Page Range | 76843-78019 | |
FR Document |
Page and Subject | |
---|---|
81 FR 76974 - Sunshine Act Meeting Notice | |
81 FR 76950 - Center for Scientific Review; Notice of Closed Meetings | |
81 FR 76914 - Grant of Authority; Establishment of a Foreign-Trade Zone, Under the Alternative Site Framework, Vancouver, Washington | |
81 FR 76916 - 1-Hydroxyethylidene-1, 1-Diphosphonic Acid From the People's Republic of China: Affirmative Preliminary Determination of Sales at Less Than Fair Value, and Postponement of Final Determination | |
81 FR 76919 - Quarterly Update to Annual Listing of Foreign Government Subsidies on Articles of Cheese Subject to an In-Quota Rate of Duty | |
81 FR 76920 - Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity To Request Administrative Review | |
81 FR 76915 - Approval of Subzone Status; Westlake Chemical Corporation; Sulphur, Louisiana | |
81 FR 76915 - Foreign-Trade Zone 44-Morris County, New Jersey; Application for Subzone; AGFA Corporation; Branchburg, New Jersey | |
81 FR 76945 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
81 FR 76946 - Agency Information Collection Activities: Submission for OMB Review; Comment Request | |
81 FR 76957 - 60-Day Notice of Proposed Information Collection: Improving the Speed of Housing Recovery Program Launch After Severe Disasters | |
81 FR 76914 - Foreign-Trade Zone (FTZ) 80-San Antonio, Texas; Notification of Proposed Production Activity; CGT U.S., Ltd.; (Polyvinyl Chloride (PVC) Coated Upholstery Fabric Cover Stock); New Braunfels, Texas | |
81 FR 76962 - Notice of Additional Scoping Meeting for the Columbia River System Operations Environmental Impact Statement | |
81 FR 76915 - Foreign-Trade Zone (FTZ) 44-Morris County, New Jersey; Authorization of Production Activity; Givaudan Flavors Corporation (Flavor Products); East Hanover, New Jersey | |
81 FR 76942 - Clean Air Act Advisory Committee (CAAAC): Notice of Meeting | |
81 FR 76962 - Notice on Outer Continental Shelf Oil and Gas Lease Sales | |
81 FR 76953 - Florida; Amendment No. 1 to Notice of an Emergency Declaration | |
81 FR 76927 - 36(b)(1) Arms Sales Notification | |
81 FR 76942 - Environmental Impact Statements; Notice of Availability | |
81 FR 76968 - Proposed Extension of Information Collection; Health Standards for Diesel Particulate Matter Exposure (Underground Coal Mines) | |
81 FR 76923 - Procurement List; Addition | |
81 FR 76923 - Procurement List; Proposed Addition and Deletions | |
81 FR 76955 - Georgia; Amendment No. 1 to Notice of an Emergency Declaration | |
81 FR 76955 - Florida; Amendment No. 2 to Notice of a Major Disaster Declaration | |
81 FR 76954 - Wisconsin; Major Disaster and Related Determinations | |
81 FR 76956 - South Carolina; Amendment No. 4 to Notice of a Major Disaster Declaration | |
81 FR 76954 - South Carolina; Amendment No. 5 to Notice of a Major Disaster Declaration | |
81 FR 76994 - National Express LLC-Acquisition of Control-Trinity, Inc., Trinity Cars, Inc., and Trinity Student Delivery, LLC | |
81 FR 76875 - Fisheries of the Exclusive Economic Zone Off Alaska; Exchange of Flatfish in the Bering Sea and Aleutian Islands Management Area | |
81 FR 76955 - South Carolina; Amendment No. 6 to Notice of a Major Disaster Declaration | |
81 FR 76956 - South Carolina; Amendment No. 3 to Notice of a Major Disaster Declaration | |
81 FR 76954 - South Carolina; Amendment No. 1 to Notice of a Major Disaster Declaration | |
81 FR 76956 - South Carolina; Amendment No. 2 to Notice of a Major Disaster Declaration | |
81 FR 76874 - Atlantic Highly Migratory Species; Atlantic Bluefin Tuna Fisheries; 2016 General Category Fishery | |
81 FR 76861 - Amendments to OFAC Regulations To Remove the Former Liberian Regime of Charles Taylor Sanctions Regulations and References to Fax-on-Demand Service | |
81 FR 76994 - Notice of Public Meeting | |
81 FR 76992 - 30-Day Notice of Proposed Information Collection: Statement of Material Change, Merger, Acquisition, or Divestment of a Registered Party | |
81 FR 76932 - 36(b)(1) Arms Sales Notification | |
81 FR 76918 - Meeting of the United States Travel and Tourism Advisory Board | |
81 FR 76934 - 36(b)(1) Arms Sales Notification | |
81 FR 76939 - Innovative Solar 47, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
81 FR 76939 - Midcontinent Independent System Operator, Inc.; Notice of Institution of Section 206 Proceeding and Refund Effective Date | |
81 FR 76938 - Quantum Power Corp; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
81 FR 76941 - Combined Notice of Filings | |
81 FR 76939 - Combined Notice of Filings #1 | |
81 FR 76965 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Currently Approved Collection: Capital Punishment Report of Inmates Under Sentence of Death | |
81 FR 76963 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Application and Permit for Permanent Exportation of Firearms (National Firearms Act) ATF F 9 (5320.9) | |
81 FR 76964 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Currently Approved Collection: National Drug Threat Survey | |
81 FR 76944 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
81 FR 76943 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
81 FR 76936 - Intent To Prepare a Draft Environmental Impact Statement, and Intent To Conduct Public Scoping Meetings for the Upper Susquehanna River Basin Comprehensive Flood Damage Reduction Study, New York | |
81 FR 76938 - President's Council of Advisors on Science and Technology | |
81 FR 76927 - Proposed Collection; Comment Request | |
81 FR 76972 - Privacy Act of 1974, as Amended; System of Records Notice | |
81 FR 76865 - Special Local Regulations; Key West World Championship, Key West, FL | |
81 FR 76966 - Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act | |
81 FR 76967 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; American Time Use Survey | |
81 FR 76966 - Federal-State Unemployment Compensation Program: Certifications for 2016 Under the Federal Unemployment Tax Act | |
81 FR 76960 - Notice of Availability of the Draft Archeological Resources Management Plan, Environmental Impact Statement, Knife River Indian Villages National Historic Site, North Dakota | |
81 FR 76929 - 36(b)(1) Arms Sales Notification | |
81 FR 77002 - Sanctions Action Pursuant to Executive Order 13224 | |
81 FR 76913 - Agenda and Notice of Public Meeting of the Maine Advisory Committee; Correction | |
81 FR 76949 - Withdrawal of 60-Day Notice of Proposed Information Collection: Unaccompanied Children Case Summary Form | |
81 FR 76937 - Notice of Availability of Record of Decision for the Northwest Training and Testing Final Environmental Impact Statement/Overseas Environmental Impact Statement | |
81 FR 77001 - Agency Information Collection Activities: Information Collection Renewal; Comment Request; Appraisals for Higher-Priced Mortgage Loans | |
81 FR 76867 - International Trademark Classification Changes | |
81 FR 76877 - Energy Conservation Program: Test Procedures for Integrated Light-Emitting Diode Lamps | |
81 FR 76870 - Suspension of Community Eligibility | |
81 FR 76924 - Agency Information Collection Activities: Comment Request | |
81 FR 76922 - Marine Mammals; File No. 15324 | |
81 FR 76922 - U.S. Integrated Ocean Observing System (IOOS®) Advisory Committee | |
81 FR 76969 - Notice of Intent To Award-Grant Awards for the Provision of Civil Legal Services to Eligible Low-Income Clients Beginning January 1, 2017 | |
81 FR 77000 - Advisory Committee on Transportation Equity | |
81 FR 76948 - Announcement of the Award of Nine Single-Source Program Expansion Supplement Grants Under the Unaccompanied Children's (UC) Program | |
81 FR 76925 - Change to the Freight Carrier Registration Program (FCRP) Open Season | |
81 FR 76912 - Black Hills National Forest Advisory Board | |
81 FR 76960 - Indian Gaming; Tribal-State Class III Gaming Compact Taking Effect in the State of California | |
81 FR 76925 - Government-Industry Advisory Panel; Notice of Federal Advisory Committee Meeting | |
81 FR 76944 - Agency Forms Undergoing Paperwork Reduction Act Review | |
81 FR 76973 - Business and Operations Advisory Committee; Notice of Meeting | |
81 FR 76931 - Charter Renewal of Department of Defense Federal Advisory Committees | |
81 FR 76974 - Advisory Committee for Education and Human Resources; Notice of Meeting | |
81 FR 77003 - Privacy Act of 1974; Department of the Treasury, Bureau of Engraving and Printing (BEP) -.051-BEP Chief Counsel Files System of Records | |
81 FR 76911 - Information Collection Request; Inventory Property Management | |
81 FR 76999 - Notice of Proposed Buy America Public Interest Waiver for Hurricane Sandy Emergency Relief Work Performed for the World Trade Center | |
81 FR 76866 - Drawbridge Operation Regulations; Tchefuncta River, Madisonville, LA | |
81 FR 76889 - Drawbridge Operation Regulations; Tchefuncta River, Madisonville, LA | |
81 FR 76997 - Notice of Proposed Buy America Waiver for Replacement Parts on Diesel Multiple Unit Rail Vehicles | |
81 FR 76953 - National Offshore Safety Advisory Committee; Vacancies | |
81 FR 76913 - Notice of Petitions by Firms for Determination of Eligibility To Apply for Trade Adjustment Assistance | |
81 FR 76962 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest | |
81 FR 76991 - Florida Disaster Number FL-00121 | |
81 FR 76977 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change Relating to the Listing and Trading of Shares of the ForceShares Daily 4X US Market Futures Long Fund and ForceShares Daily 4X US Market Futures Short Fund Under Commentary .02 to NYSE Arca Equities Rule 8.200 | |
81 FR 76975 - Order Granting a Limited Exemption From Rule 102 of Regulation M Concerning NASDAQ Stock Market LLC's New Product Support Incentives Pursuant to Regulation M Rule 102(e) | |
81 FR 76988 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Its Fee Schedule | |
81 FR 76987 - Self-Regulatory Organizations; ICE Clear Credit LLC; Order Approving Proposed Rule Change To Provide for the Clearance of Additional Credit Default Swap Contracts | |
81 FR 76990 - Florida Disaster Number FL-00120 | |
81 FR 76991 - Military Reservist Economic Injury Disaster Loans Interest Rate for First Quarter FY 2017 | |
81 FR 76990 - South Carolina Disaster Number SC-00041 | |
81 FR 76942 - Information Collections Being Reviewed by the Federal Communications Commission Under Delegated Authority | |
81 FR 76991 - Florida Disaster Number FL-00120. | |
81 FR 76990 - North Carolina Disaster Number NC-00081 | |
81 FR 76911 - Fremont and Winema Resource Advisory Committee | |
81 FR 76912 - Fremont and Winema Resource Advisory Committee | |
81 FR 76924 - Information Collection; Submission for OMB Review, Comment Request | |
81 FR 76997 - Notice of Cancellation of Environmental Impact Statement for the Norfolk International Airport, Norfolk, Virginia | |
81 FR 76997 - Passenger Facility Charge (PFC) Program; Draft FAA Order 5500.1B | |
81 FR 76848 - Airworthiness Directives; The Boeing Company Airplanes | |
81 FR 76949 - National Institute of Aging (NIA), National Institute of Mental Health (NIMH), and National Center for Advancing Translational Sciences (NCATS): Cooperative Research and Development Agreement (CRADA) and Licensing Opportunity for Ketamine for the Treatment of Depression and Other Anxiety-Related Disorders | |
81 FR 76951 - Proposed Collection; 60-Day Comment Request; The Atherosclerosis Risk in Communities Study (National Heart Lung and Blood Institute) | |
81 FR 76958 - Endangered Species; Receipt of Applications for Permit | |
81 FR 76952 - National Institute of Mental Health Amended Notice of Meeting | |
81 FR 76952 - Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting | |
81 FR 76974 - Notice of Permit Modification Received Under the Antarctic Conservation Act of 1978 | |
81 FR 76908 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Reef Fish Fishery of the Gulf of Mexico; Amendment 43 | |
81 FR 76948 - Submission for OMB Review; Comment Request | |
81 FR 76891 - Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality Planning Purposes; Louisiana; Redesignation of Baton Rouge Nonattainment Area, 2008 8-Hour Ozone Nonattainment Area to Attainment | |
81 FR 76899 - Medicare and Medicaid Programs; Fire Safety Requirements for Certain Dialysis Facilities | |
81 FR 76863 - Technical Amendments to Various Bank Secrecy Act Regulations | |
81 FR 76859 - Amendments to the Export Administration Regulations: Update of Arms Embargoes on Cote d'Ivoire, Liberia, Sri Lanka and Vietnam, and Recognition of India as Member of the Missile Technology Control Regime | |
81 FR 76961 - Record of Decision for Non-Federal Oil and Gas Regulation Revision Environmental Impact Statement (EIS) | |
81 FR 77972 - General Provisions and Non-Federal Oil and Gas Rights | |
81 FR 76958 - Federal Property Suitable as Facilities To Assist the Homeless | |
81 FR 76905 - Proposed Supplementary Rules for Fort Ord National Monument, California | |
81 FR 76857 - Establishment of Class E Airspace; Camden, AL | |
81 FR 76858 - Establishment of Class E Airspace; Murray, KY | |
81 FR 76886 - Proposed Establishment of Class E Airspace, Thermopolis, WY | |
81 FR 76855 - Amendment of Class D and Class E Airspace; Eugene, OR, and Corvallis, OR | |
81 FR 76854 - Amendment of Class E Airspace; Albany, OR | |
81 FR 76888 - Proposed Amendment of Class E Airspace, Monongahela, PA | |
81 FR 76845 - Airworthiness Directives; Pilatus Aircraft Ltd. Airplanes | |
81 FR 76883 - Airworthiness Directives; Pilatus Aircraft Ltd. Airplanes | |
81 FR 78015 - Defense Federal Acquisition Regulation Supplement: Offset Costs (DFARS Case 2015-D028) | |
81 FR 78014 - Defense Federal Acquisition Regulation Supplement: Independent Research and Development Expenses (DFARS Case 2016-D017) | |
81 FR 78012 - Defense Federal Acquisition Regulation Supplement: Pilot Program on Acquisition of Military Purpose Nondevelopmental Items (DFARS Case 2016-D014) | |
81 FR 78011 - Defense Federal Acquisition Regulation Supplement: Contiguous United States (DFARS Case 2016-D005) | |
81 FR 78008 - Defense Federal Acquisition Regulation Supplement: Enhancing the Effectiveness of Independent Research and Development (DFARS Case 2016-D002) | |
81 FR 76885 - Airworthiness Directives; Turbomeca S.A. Turboshaft Engines | |
81 FR 76843 - Airworthiness Directives; Saab AB, Saab Aeronautics (Formerly Known as Saab AB, Saab Aerosystems) Airplanes | |
81 FR 77834 - Medicare Program; End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care Model | |
81 FR 76851 - Airworthiness Directives; The Boeing Company Airplanes | |
81 FR 77008 - Medicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive Under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models |
Farm Service Agency
Forest Service
Economic Development Administration
Foreign-Trade Zones Board
Industry and Security Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Patent and Trademark Office
Army Department
Defense Acquisition Regulations System
Engineers Corps
Navy Department
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Children and Families Administration
National Institutes of Health
Coast Guard
Federal Emergency Management Agency
Fish and Wildlife Service
Indian Affairs Bureau
Land Management Bureau
National Park Service
Ocean Energy Management Bureau
Reclamation Bureau
Alcohol, Tobacco, Firearms, and Explosives Bureau
Employment and Training Administration
Mine Safety and Health Administration
Federal Aviation Administration
Federal Transit Administration
Comptroller of the Currency
Financial Crimes Enforcement Network
Foreign Assets Control Office
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.
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Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are superseding Airworthiness Directive (AD) 2012-24-06 for certain Saab AB, Saab Aeronautics Model 340A (SAAB/SF340A) and SAAB 340B airplanes. AD 2012-24-06 required replacing the stall warning computer (SWC) with a new SWC that provides an artificial stall warning in icing conditions, and modifying the airplane for the replacement of the SWC. This new AD adds airplanes to the applicability, and adds requirements to replace the existing SWCs with new, improved SWCs, and to modify the airplane for the new replacement of the SWC. This new AD also reduces the compliance time for replacing the SWCs. This AD was prompted by a determination that airplanes with certain modifications were excluded from the applicability in AD 2012-24-06, and are affected by the identified unsafe condition; and that the SWC required by AD 2012-24-06 contained erroneous logic. We are issuing this AD to prevent natural stall events during operation in icing conditions, which could result in loss of control of the airplane.
This AD is effective December 9, 2016.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of December 9, 2016.
For service information identified in this final rule, contact Saab AB, Saab Aeronautics, SE-581 88, Linköping, Sweden; telephone +46 13 18 5591; fax +46 13 18 4874; email
You may examine the AD docket on the Internet at
Shahram Daneshmandi, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1112; fax 425-227-1149.
We issued a supplemental notice of proposed rulemaking (SNPRM) to amend 14 CFR part 39 to supersede AD 2012-24-06, Amendment 39-17276 (77 FR 73279, December 10, 2012) (“AD 2012-24-06”). AD 2012-24-06 applied to certain Saab AB, Saab Aeronautics Model 340A (SAAB/SF340A) and SAAB 340B 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 2014-0218, dated September 29, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition on certain Saab AB, Saab Aeronautics Model 340A (SAAB/SF340A) and SAAB 340B airplanes. The MCAI states:
A few natural stall events, specifically when operating in icing conditions, have been experienced on SAAB 340 series aeroplanes, without receiving a prior stall warning.
This condition, if not corrected, could result in loss of control of the aeroplane.
To address this potential unsafe condition, SAAB developed a modified stall warning system, incorporating improved stall warning logic, and issued Service Bulletin (SB) 340-27-098 and SB 340-27-099, providing instructions to replace the Stall Warning Computer (SWC) with a new SWC, and instructions to activate the new SWC. The new system included stall warning curves optimized for operation in icing conditions, which are activated by selection of Engine Anti-Ice.
Consequently, EASA issued AD 2011-0219 to require installation of the improved SWC.
After that [EASA] AD was issued, in-service experience with the improved stall warning system revealed cases of premature stall warning activation during the take-off phase. In numerous recorded cases, the onset of stall warning occurred without the 6 minute delay after weight off wheels.
This condition, if not corrected, could lead to premature stick shaker activation and consequent increase in pilot workload during the take-off phase, possibly resulting in reduced control of the aeroplane.
To correct this unsafe condition, EASA issued AD 2013-0254 retaining the requirements of EASA AD 2011-0219, which was superseded, to require deactivation of the ice speed curves in the improved SWC on SAAB 340 aeroplanes, in accordance with SAAB SB 340-27-116.
Since EASA AD 2013-0254 was issued, SAAB developed a technical solution to eliminate the premature activation of the stall warning ice curves and issued SB 340-27-120 (modification of the existing Stall Warning System installation), SB 340-27-121 (activation of improved SWC for aeroplanes with a basic wing tip) and SB 340-27-122 (activation of improved SWC for aeroplanes with an extended wing tip). SAAB SB 340-27-120 provides modification and installation instructions valid for pre- and post-SB 340-27-097, 340-27-098, SB 340-27-099 and SB 340-27-116 aeroplanes. For aeroplanes modified in accordance with SAAB AB mod. No. 2650 and/or mod. No. 2859 which are no longer registered in Canada, SAAB AB issued SAAB AB SB 340-27-109 to provide modification and installation instructions to remove the ice speed curve function.
For the reasons described above, this [EASA] AD retains the requirements of EASA AD 2013-0254, which is superseded, and requires modification of the Stall Warning and Identification System and replacement of the SWC with an improved unit.
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 received no comments on the SNPRM or on the determination of the cost to the public.
We reviewed the available data and determined that air safety and the public interest require adopting 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 SNPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the SNPRM.
Saab AB, Saab Aeronautics has issued the following service information:
• Saab Service Bulletin 340-27-109, dated April 14, 2014.
• Saab Service Bulletin 340-27-116, dated October 18, 2013.
• Saab Service Bulletin 340-27-120, dated July 11, 2014.
• Saab Service Bulletin 340-27-121, dated July 11, 2014.
• Saab Service Bulletin 340-27-122, dated July 11, 2014.
The service information describes procedures for deactivating the stall warning speed curves in the SWCs for certain airplanes; replacing the existing SWCs with new, improved SWCs; and modifying the airplane for the new replacement of the SWC. These documents are distinct since they apply to different airplane models in different 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 105 airplanes of U.S. registry.
The actions required by AD 2012-24-06 and retained in this AD, take about 78 work-hours per product, at an average labor rate of $85 per work-hour. Required parts cost about $33,000 per product. Based on these figures, the estimated cost of the actions that were required by AD 2012-24-06 is $39,630 per product.
The new requirement of this AD adds no additional economic burden.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under 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 9, 2016.
This AD replaces AD 2012-24-06, Amendment 39-17276 (77 FR 73279, December 10, 2012) (“AD 2012-24-06”).
This AD applies to Saab AB, Saab Aeronautics (formerly known as Saab AB, Saab Aerosystems) Model 340A (SAAB/SF340A) and SAAB 340B airplanes, certificated in any category, as identified in paragraphs (c)(1) and (c)(2) of this AD.
(1) Model 340A (SAAB/SF340A) airplanes, serial numbers 004 through 159 inclusive.
(2) Model SAAB 340B airplanes, serial numbers 160 through 459 inclusive, except serial numbers 170, 342, 362, 363, 367, 372, 379, 385, 395, 405, 409, 431, 441, and 455.
Air Transport Association (ATA) of America Code 27, Flight Controls.
This AD was prompted by a determination that airplanes with certain modifications were excluded from the applicability in AD 2012-24-06, and are affected by the identified unsafe condition; and the stall warning computer (SWC) required by AD 2012-24-06 contained erroneous logic. We are issuing this AD to prevent natural stall events during operation in icing conditions, which could result in loss of control of the airplane.
Comply with this AD within the compliance times specified, unless already done.
For airplanes identified in paragraphs (g)(1) and (g)(2) of this AD: Within 30 days after the effective date of this AD, do the deactivation specified in paragraph (g)(1) or (g)(2) of this AD, as applicable to airplane configuration, in accordance with the Accomplishment Instructions of Saab Service Bulletin 340-27-116, dated October 18, 2013.
(1) For airplanes with a basic wing tip that has been modified using Saab Service Bulletin 340-27-098: Deactivate the stall speed curves in the SWC having part number (P/N) 0020AK6.
(2) For airplanes with an extended wing tip that has been modified using Saab Service Bulletin 340-27-099: Deactivate the stall speed curves in the SWC having P/N 0020AK7.
Within 3 months after the effective date of this AD: Do the replacement specified in paragraph (h)(1) or (h)(2) of this AD, as applicable.
Before or concurrently with the accomplishment of the applicable requirements of paragraph (h) of this AD, do the actions specified in paragraph (i)(1) or (i)(2) of this AD, as applicable to airplane configuration.
(1) For airplanes on which either Saab AB Modification 2650 or Modification 2859 is not installed: Modify the stall warning and identification system, in accordance with the Accomplishment Instructions of Saab Service Bulletin 340-27-120, dated July 11, 2014.
(2) For airplanes on which either Saab AB Modification 2650 or Modification 2859 is installed, or on which both modifications are installed: Modify the stall warning and identification system, in accordance with the Accomplishment Instructions of Saab Service Bulletin 340-27-109, dated April 14, 2014.
After the replacement required by paragraph (h) of this AD, no person may install any SWC having P/N 0020AK, 0020AK1, 0020AK2, 0020AK4, 0020AK6, 0020AK7, or 0020AK3 MOD 1, on any airplane.
The following provisions also apply to this AD:
(1)
(2)
Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2014-0218, dated September 29, 2014, for related information. This MCAI may be found in the AD docket on the Internet at
(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) Saab Service Bulletin 340-27-109, dated April 14, 2014.
(ii) Saab Service Bulletin 340-27-116, dated October 18, 2013.
(iii) Saab Service Bulletin 340-27-120, dated July 11, 2014.
(iv) Saab Service Bulletin 340-27-121, dated July 11, 2014.
(v) Saab Service Bulletin 340-27-122, dated July 11, 2014.
(3) For service information identified in this AD, contact Saab AB, Saab Aeronautics, SE-581 88, Linköping, Sweden; telephone +46 13 18 5591; fax +46 13 18 4874; email
(4) You may view this service information at the FAA, Transport Airplane Directorate, 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; request for comments.
We are adopting a new airworthiness directive (AD) for all Pilatus Aircraft Ltd. Models PC-6, PC-6-H1, PC-6-H2, PC-6/350, PC-6/350-H1, PC-6/350-H2, PC-6/A, PC-6/A-H1, PC-6/A-H2, PC-6/B-H2, PC-6/B1-H2, PC-6/B2-H2, PC-6/B2-H4, PC-6/C-H2, and PC-6/C1-H2 airplanes. This AD results from mandatory continuing airworthiness information (MCAI) issued by the aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as wear and cracks on the stabilizer-trim attachment and structural components. We are issuing this AD to require actions to address the unsafe condition on these products.
This AD is effective November 4, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of November 4, 2016.
We must receive comments on this AD by December 19, 2016.
You may send comments by any of the following methods:
•
•
•
•
For service information identified in this AD, contact Pilatus Aircraft Ltd., Customer Liaison Manager, CH-6371 STANS, Switzerland; telephone: +41 41 619 3333; fax: +41 41 619 7311; Internet:
You may examine the AD docket on the Internet at
Doug Rudolph, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4059; fax: (816) 329-4090; email:
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued Emergency AD No. 2016-0202-E, dated October 7, 2016 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:
Wear and cracks on the stabilizer-trim attachment and relevant structural components have been reported on aeroplanes having accomplished Pilatus Service Bulletin (SB) 53-001 Revision 1, as previously required by FOCA AD HB-2005-263.
Subsequent investigation identified that slightly asymmetric installation and/or operational conditions may result in strong stabilizer vibration, causing crack initiation in the stabilizer-trim attachment fitting or connecting piece.
This condition, if not detected and corrected, may lead to a failure of the fitting or connecting piece, possibly resulting in disconnection of the horizontal stabilizer rear attachment, with consequent loss of control of the aeroplane.
To address this potential unsafe condition, Pilatus issued SB No. 53-003 (hereafter referred to as `the SB' in this AD) to provide inspection instructions.
For the reason described above, this AD requires visual and non destructive inspections of the affected stabilizer-trim attachment components and the related parts and structure to detect cracks, and, depending on findings, the replacement of the affected parts. This AD also provides additional requirements for installation of these parts.
Pilatus Aircraft Ltd. has issued PC-6 Service Bulletin No. 53-003, Revision 1, dated October 13, 2016. The service information describes procedures for inspecting the stabilizer-trim attachment components and the related parts and structure to detect cracks and replacing all cracked parts. 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
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all information provided by the State of Design Authority and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.
An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because failure of the stabilizer control system fitting or connecting piece could result in disconnection of the horizontal stabilizer rear attachment, with consequent loss of control. Therefore, we determined that notice and opportunity for public comment before issuing this AD are impracticable and that good cause exists for making this amendment effective in fewer than 30 days.
This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We estimate that this AD will affect 30 products of U.S. registry. We also estimate that it will take about 5 work-hours per product to comply with the basic inspection 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 $12,750, or $425 per product.
In addition, we estimate that any necessary follow-on replacement actions will take about 6 work-hours and
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.
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 airworthiness directive (AD) becomes effective November 4, 2016.
None.
(1) This AD applies to PILATUS Models PC-6, PC-6-H1, PC-6-H2, PC-6/350, PC-6/350-H1, PC-6/350-H2, PC-6/A, PC-6/A-H1, PC-6/A-H2, PC-6/B-H2, PC-6/B1-H2, PC- 6/B2-H2, PC-6/B2-H4, PC-6/C-H2, and PC-6/C1-H2 airplanes, all manufacturer serial numbers, including MSN 2001 through 2092 (see Note 1 of paragraph c), certificated in any category.
For MSN 2001-2092, these airplanes are also identified as Fairchild Republic Company PC-6 airplanes, Fairchild Industries PC-6 airplanes, Fairchild Heli Porter PC-6 airplanes, or Fairchild-Hiller Corporation PC-6 airplanes.
(2) For the purpose of this AD, an “affected part” is any stabilizer-trim attachment component and the related parts and structure, as identified in Pilatus Aircraft Ltd. (Pilatus) PC-6 Service Bulletin (SB) No. 53-003, Revision 1, dated October 13, 2016.
Air Transport Association of America (ATA) Code 53: Fuselage.
This AD results from mandatory continuing airworthiness information (MCAI) issued by the aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as wear and cracks on the stabilizer-trim attachment and structural components. This condition, if not corrected, could cause failure of the stabilizer control system fitting or connecting piece, which could result in disconnection of the horizontal stabilizer rear attachment with consequent loss of control.
Unless already done, do the following actions.
(1)
(2)
(3)
(4)
(5)
This AD allows credit for the visual inspection required in paragraph (f)(1) of this
The following provisions also apply to this AD:
(1)
(2)
(3)
Refer to MCAI European Aviation Safety Agency (EASA) AD No. 2016-0202-E, dated October 7, 2016, and Pilatus Aircraft Ltd. PC-6 Service Bulletin No. 53-003, dated October 4, 2016. You may examine the MCAI on the Internet at
(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) Pilatus Aircraft Ltd. PC-6 Service Bulletin No. 53-003, Revision 1, dated October 13, 2016.
(ii) Reserved.
(3) For Pilatus Aircraft Ltd. service information identified in this AD, contact Pilatus Aircraft Ltd., Customer Liaison Manager, CH-6371 STANS, Switzerland; telephone: +41 41 619 3333; fax: +41 41 619 7311; Internet:
(4) You may view this service information at the FAA, FAA, Small Airplane Directorate, 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 all The Boeing Company Model MD-90-30 airplanes. This AD requires a detailed inspection of the forward and aft surfaces on the left and right sides at the cant station 1520 bulkhead for any crack in the upper cap and (cap) doubler, webs and doublers, stiffeners, and the lower tee cap between longerons 3 through 11, and repairs if necessary. This AD was prompted by a report of cracking in various structures in the fuselage cant station 1520 bulkhead. We are issuing this AD to detect and correct cracking in the bulkhead, which could result in reduced structural integrity of the airplane.
This AD is effective November 21, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of November 21, 2016.
We must receive comments on this AD by December 19, 2016.
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 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
George Garrido, Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification Office
We have received a report indicating an operator found cracking of various structures in the fuselage cant station 1520 bulkhead on a Model MD-90-30 airplane. The cracks were in the upper left area of the bulkhead, between longerons 5 and 10, in the web, lower tee cap, and the upper cap and (cap) doubler. The affected airplane had accumulated 52,993 total flight hours and 28,718 total flight cycles. Boeing analysis determined that the operational and limit loads cannot duplicate this condition, and the root cause is suspected to be the result of a high load event based on service experience. Cracking of the bulkhead, if not detected and corrected, could result in the inability of the structure to sustain limit loads, and consequent reduced structural integrity of the airplane. We are issuing this AD to correct the unsafe condition on these products.
We reviewed Boeing Alert Service Bulletin MD90-53A037, dated September 19, 2016. The service information describes procedures for a detailed inspection of the forward and aft surfaces on the left and right sides at cant station 1520 bulkhead for any crack in the upper cap and (cap) doubler, webs and doublers, stiffeners, and the lower tee cap between longerons 3 through 11, and repairs. 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 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 accomplishing the actions specified in the service information described previously, except as discussed under “Differences Between this Proposed AD and the Service Information.” For information on the procedures and compliance times, see this service information at
Boeing Alert Service Bulletin MD90-53A037, dated September 19, 2016, specifies to contact the manufacturer for certain instructions, but this AD would require accomplishment of repair methods, modification deviations, and alteration deviations in one of the following ways:
• In accordance with a method that we approve; or
• Using data that meet the certification basis of the airplane, and that have been approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) whom we have authorized to make those findings.
An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because undetected cracking of the bulkhead may result in the inability of the structure to sustain limit loads, and consequent reduced structural integrity of the airplane. Therefore, we find that notice and opportunity for prior public comment are impracticable and 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 AD. 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 71 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 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
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 21, 2016.
None.
This AD applies to all The Boeing Company Model MD-90-30 airplanes, certificated in any category.
Air Transport Association (ATA) of America Code 53, Fuselage.
This AD was prompted by a report of cracking in various structures in the fuselage cant station 1520 bulkhead. We are issuing this AD to detect and correct cracking in the bulkhead, which could result in reduced structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
At the applicable time specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin MD90-53A037, dated September 19, 2016, except as required by paragraph (j) of this AD: On the left and right sides at the cant station 1520 bulkhead, do a detailed inspection of the forward and aft surfaces, for any crack in the upper cap and (cap) doubler, webs and doublers, stiffeners, and the lower tee cap between longerons 3 through 11, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin MD90-53A037, dated September 19, 2016.
If any crack is found in the bulkhead web or doubler, do the repair in accordance with Boeing Alert Service Bulletin MD90-53A037, dated September 19, 2016. Do all repairs before further flight.
If any non-web or non-doubler crack is found in the bulkhead, repair before further flight using a method approved in accordance with the procedures specified in paragraph (l) of this AD.
Where paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin MD90-53A037, dated September 19, 2016, specifies a compliance time “after the original issue date of this service bulletin,” this AD requires compliance within the specified compliance time after the effective date of this AD.
Special flight permits may be issued in accordance with sections 21.197 and 21.199 of the Federal Aviation Regulations (14 CFR 21.197 and 21.199) to operate the airplane to a location where the airplane can be repaired, but if any crack is found as identified in Boeing Alert Service Bulletin MD90-53A037, dated September 19, 2016, concurrence by the Manager, Los Angeles Aircraft Certification Office (ACO), FAA, is required before issuance of the special flight permit.
(1) The Manager, Los Angeles ACO, 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 (m) 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, 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 (j) of this AD: For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (l)(4)(i) and (l)(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 George Garrido, Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification Office (ACO), 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5232; 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 MD90-53A037, dated September 19, 2016.
(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 Airplane Directorate, 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 superseding Airworthiness Directive (AD) 2006-20-11 for certain The Boeing Company Model 757-200, -200CB, and -200PF series airplanes. AD 2006-20-11 required initial and repetitive detailed or high frequency eddy current (HFEC) inspections for cracks around the rivets at the upper fastener row of the skin lap splice of the fuselage, and repair of any crack found. This new AD no longer allows the detailed inspections and instead requires repetitive external HFEC inspections for cracking of the skin lap splices of the fuselage, and repair if necessary. This AD was prompted by an evaluation done by the design approval holder (DAH) indicating that the fuselage skin lap splice is subject to widespread fatigue damage (WFD). We are issuing this AD to detect and correct fatigue cracking at certain skin lap splice locations of the fuselage, which could result in reduced structural integrity and rapid decompression of the airplane.
This AD is effective December 9, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of December 9, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain other publication listed in this AD as of November 8, 2006 (71 FR 58485, October 4, 2006).
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; telephone 562-797-1717; Internet
You may examine the AD docket on the Internet at
Eric Schrieber, Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification Office (ACO), 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5348; fax: 562-627-5210; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2006-20-11, Amendment 39-14781 (71 FR 58485, October 4, 2006) (“AD 2006-20-11”). AD 2006-20-11 applied to certain The Boeing Company Model 757-200, -200CB, and -200PF series airplanes. The NPRM published in the
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 provided comments that supported the intent of the NPRM.
Boeing and United Airlines (UA) asked that we change the compliance time for the repetitive HFEC inspections specified in paragraph (j) of the proposed AD. Boeing learned that some operators began doing inspections long before the 37,500-flight-cycle threshold was attained. Boeing stated that the compliance table in Boeing Special Attention Service Bulletin 757-53-0090, Revision 1, dated November 19, 2015, provided grace periods for doing the HFEC inspections after doing previous inspections, but did not provide for previous inspections being done within the grace period or before the required threshold of 37,500 flight cycles, whichever occurs later. Boeing added that, as written, the service information specifies repetitive inspections within 3,000 flight cycles after any previous detailed inspection and within 12,000 flight cycles after any previous HFEC inspection—even if the interval occurred before the 37,500-flight-cycle threshold.
UA stated that if an operator decided to proactively accomplish either a detailed or HFEC inspection before the specified compliance time in, and in accordance with either Boeing Special Attention Service Bulletin 757-53-0090, dated June 2, 2005 or Boeing Special Attention Service Bulletin 757-53-0090, Revision 1, dated November 19, 2015, then the inspection would have to be repeated within 3,000 or 12,000 flight cycles, depending on which inspection was previously done. UA stated that this compliance time could be much sooner than the intended 37,500 flight cycles. UA noted that it discussed this problem with Boeing and hoped it could be clarified in the NPRM.
We agree with the commenters' requests to change the compliance time for the repetitive HFEC inspections specified in paragraph (j) of this AD. According to the proposed AD, operators that accomplished the inspections early would be required to do the inspections before reaching the inspection threshold specified in paragraph (j) of the proposed AD. It was not the intent of Boeing or the FAA to require that the airplane be inspected
Aviation Partners Boeing stated that accomplishing the supplemental type certificate (STC) ST01518SE does not affect compliance with the actions specified in the NPRM.
We agree with the commenter. We have redesignated paragraph (c) of the proposed AD as (c)(1) and added a new paragraph (c)(2) to this AD to state that installation of STC ST01518SE does not affect the ability to accomplish the actions required by this final rule. Therefore, for airplanes on which STC ST01518SE 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.
UA asked that instructions for approved repairs be incorporated into the next revision of Boeing Special Attention Service Bulletin 757-53-0090, Revision 1, dated November 19, 2015, as an AMOC to the NPRM. UA stated that the lack of approved repairs in the service information adds a significant burden to operators, Boeing Designated Airworthiness Representatives, and the Los Angeles Aircraft Certification Office.
We acknowledge the commenter's concern. If the service information is revised to include instructions for approved repairs, affected operators may request approval to use the later revision of the referenced service information as an AMOC, under the provisions of paragraph (m) of this AD. We have made no change to this AD in this regard.
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.
We reviewed Boeing Special Attention Service Bulletin 757-53-0090, Revision 1, dated November 19, 2015. The service information describes procedures for repetitive external HFEC inspections for cracking of the skin lap splices of the fuselage. 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 572 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 a cost estimate for the on-condition repairs 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.
We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(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 9, 2016.
This AD replaces AD 2006-20-11, Amendment 39-14781 (71 FR 58485, October 4, 2006) (“AD 2006-20-11”). This AD affects AD 2006-11-11, Amendment 39-14615 (71 FR 30278, May 26, 2006) (“AD 2006-11-11”).
(1) This AD applies to The Boeing Company Model 757-200, -200CB, and -200PF series airplanes, certificated in any category, as identified in Boeing Special Attention Service Bulletin 757-53-0090, Revision 1, dated November 19, 2015.
(2) Installation of Supplemental Type Certificate (STC) ST01518SE (
Air Transport Association (ATA) of America Code 53, Fuselage.
This AD was prompted by an evaluation done by the design approval holder indicating that the fuselage skin lap splice is subject to widespread fatigue damage. We are issuing this AD to detect and correct fatigue cracking at certain skin lap splice locations of the fuselage, which could result in reduced structural integrity and rapid decompression of the airplane.
Comply with this AD within the compliance times specified, unless already done.
This paragraph restates the requirements of paragraph (f) of AD 2006-20-11, with terminating action. Do initial and repetitive detailed or high frequency eddy current (HFEC) inspections for cracking around the rivets at the upper fastener row of the skin lap splice of the fuselage by doing all the actions in accordance with the Accomplishment Instructions of Boeing Special Attention Service Bulletin 757-53-0090, dated June 2, 2005, except as provided by paragraphs (h) and (i) of this AD. Do the inspections at the applicable times specified in Paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 757-53-0090, dated June 2, 2005; except where Boeing Special Attention Service Bulletin 757-53-0090, dated June 2, 2005, specifies a compliance time “after the original release date of this service bulletin,” this AD requires compliance after November 8, 2006 (the effective date of AD 2006-20-11). Accomplishing an inspection required by paragraph (j) of this AD terminates the inspections required by this paragraph.
This paragraph restates the requirements of paragraph (g) of AD 2006-20-11, with no changes. If any crack is found during any inspection required by paragraph (g) of this AD: Before further flight, repair the crack using a method approved in accordance with the procedures specified in paragraph (m) of this AD.
This paragraph restates the provision specified in paragraph (h) of AD 2006-20-11, with no changes. Although Boeing Special Attention Service Bulletin 757-53-0090, dated June 2, 2005, recommends that inspection results be reported to the manufacturer, this AD does not include that requirement.
At the applicable time specified in table 1 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 757-53-0090, Revision 1, dated November 19, 2015, except as provided by paragraphs (j)(1), (j)(2), and (l)(1) of this AD: Do an external HFEC inspection for cracking of the skin lap splices of the fuselage, in accordance with the Accomplishment Instructions of Boeing Special Attention Service Bulletin 757-53-0090, Revision 1, dated November 19, 2015. Repeat the inspection thereafter at the applicable times specified in table 1 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 757-53-0090, Revision 1, dated November 19, 2015. Doing an inspection required by this paragraph terminates the inspections required by paragraph (g) of this AD.
(1) For airplanes on which Option 1 (detailed inspection) of Boeing Special Attention Service Bulletin 757-53-0090, dated June 2, 2005, has been done: Repeat the HFEC inspection before the accumulation of 37,500 total flight cycles, or within 3,000 flight cycles after accomplishing the most recent detailed inspection, whichever occurs later.
(2) For airplanes on which Option 2 (HFEC inspection) of Boeing Special Attention Service Bulletin 757-53-0090, dated June 2, 2005, has been done: Repeat the HFEC inspection before the accumulation of 37,500 total flight cycles, or within 12,000 flight cycles after accomplishing the most recent HFEC inspection, whichever occurs later.
If any cracking is found during any inspection required by paragraph (j) of this AD, repair before further flight using a method approved in accordance with the procedures specified in paragraph (m) of this AD.
(1) Where Boeing Special Attention Service Bulletin 757-53-0090, Revision 1, dated November 19, 2015, specifies a compliance time “after the Revision 1 date of this service bulletin,” this AD requires compliance within the specified compliance time after the effective date of this AD.
(2) Although Boeing Special Attention Service Bulletin 757-53-0090, Revision 1, dated November 19, 2015, specifies to contact Boeing for repair instructions, and specifies that action as “RC” (Required for Compliance), paragraph (k) of this AD requires repair before further flight using a method approved in accordance with the procedures specified in paragraph (m) of this AD.
(1) The Manager, Los Angeles Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. 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 (n)(1) 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, 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) AMOCs approved for AD 2006-20-11, are approved as AMOCs for the corresponding provisions of paragraphs (g) and (j) of this AD.
(5) Except as required by paragraph (l)(2) of this AD: For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (m)(5)(i) and (m)(5)(ii) 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
(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.
(6) The inspections specified in paragraph (g) of this AD are approved as an AMOC to paragraph (h) of AD 2006-11-11 for the inspections of Significant Structural Items (SSI) 53-30-07 and 53-60-07 (fuselage lap splices, left and right upper fastener row) listed in the May 2003 or June 2005 revision of the Boeing 757 Maintenance Planning Data (MPD) Document D622N001-9. This AMOC applies only to the common areas identified in paragraphs (m)(6)(i) and (m)(6)(ii) of this AD. All provisions of AD 2006-11-11 that are not specifically referenced in the above statements remain fully applicable and must be complied with as specified in AD 2006-11-11. Operators may revise their maintenance or inspection program with these alternative inspections for common areas.
(i) Common areas inspected before the effective date of this AD, in accordance with the Accomplishment Instructions of Boeing Special Attention Service Bulletin 757-53-0090, dated June 2, 2005.
(ii) Common areas inspected in accordance with the Accomplishment Instructions of Boeing Special Attention Service Bulletin 757-53-0090, Revision 1, dated November 19, 2015.
For more information about this AD, contact Eric Schrieber, Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles ACO, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5348; 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.
(3) The following service information was approved for IBR on December 9, 2016.
(i) Boeing Special Attention Service Bulletin 757-53-0090, Revision 1, dated November 19, 2015.
(ii) Reserved.
(4) The following service information was approved for IBR on November 8, 2006 (71 FR 58485, October 4, 2006).
(i) Boeing Special Attention Service Bulletin 757-53-0090, dated June 2, 2005.
(ii) Reserved.
(5) 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; telephone 562-797-1717; Internet
(6) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(7) 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.
This action amends Class E airspace at Albany Municipal Airport, Albany, OR. Advances in Global Positioning System (GPS) mapping accuracy and a reliance on precise geographic coordinates to define airport and airspace reference points have made this airspace redesign necessary for the safety and management of Instrument Flight Rules (IFR) operations.
Effective 0901 UTC, January 5, 2017. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Tom Clark, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4511.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies controlled airspace at Albany Municipal Airport, Albany, OR.
On August 15, 2016, the FAA published in the
Class D and Class E airspace designations are published in paragraph 5000, 6002, 6004, and 6005, respectively, of FAA Order 7400.11A, dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR
This document amends FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the
This action amends Title 14 Code of Federal Regulations (14 CFR) Part 71 by modifying Class E airspace extending upward from 700 feet above the surface at Albany Municipal Airport, Albany, OR. Controlled airspace extends to within a 6.7-mile radius of the airport to accommodate IFR departures up to 1,200 feet above the surface; includes a small extension to the southwest to accommodate IFR arrivals below 1,500 feet above the surface; and the segment east of longitude 123° is removed, as there are no IFR operations within that area. These modifications are necessary for the safety and management of IFR operations at the airport, while preserving the navigable airspace for aviation.
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11A, dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures”, paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (Air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface, within a 6.7-mile radius of Albany Municipal Airport, beginning at the 158° bearing from the airport clockwise to the 022° bearing, thence to the point of beginning, and that airspace 1.4 miles each side of the 230° bearing from the airport extending from the 6.7-mile radius to 8.5 miles southwest of the airport.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action amends Class E airspace designated as an extension, and Class E airspace extending upward from 700 feet above the surface at Mahlon Sweet Field Airport, Eugene, OR, to accommodate airspace redesign for the safety and management of Instrument Flight Rules (IFR) operations at the airport. Corvallis Municipal Airport is removed from the Mahlon Sweet Field Airport regulatory text by creating a stand-alone airspace designation for the airport. Additionally, this action updates the airport reference points for these airports in Class D and E airspace, as well as removes the Notice to Airmen (NOTAM) requirement noted in Class E surface area airspace.
Effective 0901 UTC, January 5, 2017. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Tom Clark, Federal Aviation Administration, Operations Support Group, Western
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies controlled airspace at Mahlon Sweet Field Airport, Eugene, OR, and Corvallis Municipal Airport, Corvallis, OR.
On August 15, 2016, the FAA published in the
Class D and Class E airspace designations are published in paragraph 5000, 6002, 6004, and 6005, respectively, of FAA Order 7400.11A, dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the
The FAA is amending Title 14 Code of Federal Regulations (14 CFR) Part 71 by modifying Class E airspace designated as an extension to a Class D or Class E surface area, and Class E airspace extending upward from 700 feet above the surface at Mahlon Sweet Field Airport, Eugene, OR. The Class E surface extension to the north is slightly enlarged to contain aircraft using the VOR-A approach, and the extension to the south is enlarged to contain aircraft using the RNP (RNAV) Z instrument approaches as they descend below 1,000 feet above the surface. Class E airspace extending upward from 700 feet above the surface is reduced to the northeast and west of the airport to only that area necessary to contain IFR arrival aircraft descending below 1,500 feet above the surface, and IFR departure aircraft, until reaching 1,200 feet above the surface. The Class E airspace area extending upward from 1,200 feet above the surface is removed, as this airspace area is provided by the Bend, OR, Class E En Route airspace area.
Also, this action creates stand-alone Class E airspace extending upward from 700 feet above the surface for Corvallis Municipal Airport, Corvallis, OR, thereby removing reference to Corvallis Municipal Airport from the Mahlon Sweet Field Airport airspace designation. The overall Class E airspace area near Corvallis Municipal Airport is slightly reduced north, and slightly enlarged west of the airport. The geographic coordinates of these airports are updated for all Class D and Class E airspace areas.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from the surface to and including 2,900 feet MSL within a 4.6-mile radius of Mahlon Sweet Field Airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.
That airspace extending upward from the surface within a 4.6-mile radius of Mahlon Sweet Field Airport.
That airspace extending upward from the surface within 3 miles west and 2 miles east of the Mahlon Sweet Field Airport 008° bearing, extending from the 4.6-mile radius of the airport to 6.8 miles north of the airport, and within the area bounded by the airport 142° bearing clockwise to the airport 213° bearing, extending from the 4.6-mile radius to 13.5 miles south of the airport, and within the area bounded by the airport 213° bearing clockwise to the airport 226° bearing, extending from the 4.6-mile radius to 14 miles southwest of the airport.
That airspace extending upward from 700 feet above the surface within a 6-mile radius of Corvallis Municipal Airport, and 2.4 miles each side of the airport 007° bearing, extending from the 6-mile radius to 12.4 miles north of the airport, and 2.6 miles each side of the airport 104° bearing extending from the 6-mile radius to 7.1 miles east of the airport, and 2 miles each side of the airport 188° bearing extending from the 6-mile radius to 7.1 miles south of the airport.
That airspace extending upward from 700 feet above the surface within a 6-mile radius of Mahlon Sweet Field Airport, and that airspace within the area bounded by the airport 098° bearing clockwise to the airport 138° bearing, extending from the 6-mile radius to 18.3 miles southeast of the airport, and within the area bounded by the airport 138° bearing clockwise to the 170° bearing, extending from the 6-mile radius to 13.5 miles southeast of the airport, and within the area bounded by the airport 170° bearing clockwise to the 234° bearing, extending from the 6-mile radius to 18.3 miles southwest of the airport, and that airspace within 3.6 miles east and 8.5 miles west of the airport 008° bearing, extending from the 6-mile radius to 16 miles north of the airport.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action establishes Class E airspace at Camden, AL to accommodate new Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedures (SIAPs) serving Camden Municipal Airport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at the airport.
Effective 0901 UTC, January 5, 2017. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class E airspace at Camden Municipal Airport, Camden, AL.
On July 22, 2016, the FAA published in the
Class E airspace designations are published in Paragraph 6005 of FAA Order 7400.11A dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 establishes Class E Airspace at Camden
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120, E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 7.7-mile radius of Camden Municipal Airport.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action establishes Class E airspace at Murray, KY, to accommodate new Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedures (SIAPs) serving Murray Calloway County Hospital Heliport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at the heliport.
Effective 0901 UTC, January 5, 2017. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class E airspace at Murray Calloway County Hospital Heliport, Murray, KY.
On July 22, 2016, the FAA published in the
Class E airspace designations are published in Paragraph 6005 of FAA Order 7400.11A dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016,
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 establishes Class E Airspace at Murray Calloway County Hospital Heliport, Murray, KY. Controlled airspace extending upward from 700 feet above the surface within a 6-mile radius of the heliport is established for IFR operations.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120, E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 6-mile radius of Murray Calloway County Hospital Heliport.
Bureau of Industry and Security, Commerce.
Final rule.
In this rule, the Bureau of Industry and Security (BIS) amends the Export Administration Regulations (EAR) to implement changes in controls on arms and related materiel to Cote d'Ivoire, Liberia, Sri Lanka, and Vietnam. BIS also updates the EAR to recognize the accession of India as a member of the Missile Technology Control Regime (MTCR).
This rule is effective November 4, 2016.
Elan Mitchell-Gee, telephone (202) 482-4252, email
In this rule, BIS amends the Export Administration Regulations (EAR) to implement certain United Nations Security Council Resolutions (UNSCRs) adopted in 2016 that terminated arms embargoes against Cote d'Ivoire (UNSCR 2283) and Liberia (UNSCR 2288). Further, BIS removes U.S. arms embargo-related controls on Sri Lanka to reflect the Consolidated Appropriations Act, 2016, and on Vietnam pursuant to a determination made by the Secretary of State and announced by the President.
BIS aims to harmonize the arms embargo-related provisions in the EAR, expressly or by reference, with the Directorate of Defense Trade Control's (DDTC) regulation of arms embargoes in § 126.1 of the International Traffic in Arms Regulations (ITAR), “Prohibited Exports, Imports, and Sales to or from Certain Countries.” These actions further ongoing efforts to harmonize the EAR and the ITAR, and the President's Export Control Reform Initiative. The ITAR list incorporates countries subject to United Nations Security Council (UNSC) and U.S. arms embargoes. BIS primarily implements such controls through Country Group D: 5 “U.S. Arms Embargoed Countries,” in Supplement No. 1 to part 740 of the EAR. BIS also identifies specific countries subject to UNSC arms embargoes in part 746 of the EAR, and maintains controls on certain items pursuant to those embargoes on the Commerce Control List (CCL) in Supplement No. 1 to part 774.
Countries listed in Country Group D:5 are subject to additional restrictions in the EAR, including on
Finally, on June 27, 2016, India acceded to the Missile Technology Control Regime (MTCR) as the 35th member. In this rule, BIS updates the EAR to recognize the status of India as a member of the Missile Technology Control Regime by amending paragraph (d) of § 742.5 to remove the reference to India as an adherent to the MTCR. This rule includes a conforming amendment.
The arms embargo against Cote d'Ivoire was initially imposed through UNSCR 1572 (2004). UNSCR 2283 terminated the arms embargo against Cote d'Ivoire on April 28, 2016, in recognition of the progress achieved in the stabilization of the country, including in relation to disarmament, demobilization and reintegration, security sector reform, national reconciliation and the fight against impunity, as well as the successful conduct of the presidential election of October 25, 2015. Accordingly, this rule removes the United Nations Embargo (UN) controls on Cote d'Ivoire by removing that country from the names of UNSC arms embargoed countries in § 746.1(b) and from Country Group D:5 in Supplement No. 1 to part 740 of the EAR.
The arms embargo against Liberia was initially imposed through UNSCR 788 on November 19, 1992, and was continued through subsequent resolutions, including UNSCR 1903 (2009). The UNSC terminated the arms embargo against Liberia on May 25, 2016, through UNSCR 2288, in recognition of that country's progress in the past 13 years in building stable, effective and resilient national institutions. Accordingly, this rule removes the UN controls on Liberia by removing that country from the names of UNSC arms embargoed countries in § 746.1(b) and from Country Group D:5 in Supplement No. 1 to part 740 of the EAR.
The Department of State imposed a U.S. arms embargo on Sri Lanka on March 24, 2008, in accordance with the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2008 (Div. J, Pub. L. 110-161). However, licensing restrictions on Sri Lanka articulated in section 7044(e) of the Consolidated Appropriations Act, 2015 (Pub. L. 113-235) and in previous appropriations acts, were not carried forward in section 7044(e) of the Consolidated Appropriations Act, 2016 (Pub. L. 114-113). On May 4, 2016, DDTC announced that it would begin reviewing license applications for Sri Lanka on a case-by-case basis. Accordingly, this rule removes Sri Lanka from Country Group D:5 in Supplement No. 1 to part 740 of the EAR.
Starting in the 1960s, the Department of State imposed a lethal arms sales embargo against Vietnam. Pursuant to a determination by the Secretary of State, the President announced the United States' termination of the U.S. arms embargo against Vietnam on May 23, 2016, in furtherance of deepening and broadening ties between the United States and Vietnam since the normalization of diplomatic relations. Accordingly, BIS removes Vietnam from Country Group D:5 in Supplement No.1 to part 740 the EAR.
On June 27, 2016, India formally acceded to the MTCR as the 35th member. Prior to India's MTCR membership, India's commitment to the U.S.-India bilateral understanding contributed to the country's status as an “MTCR adherent” and placed the country among likeminded MTCR members in Country Group A:2 in Supplement No. 1 to part 740. In this rule, BIS formally recognizes India's status as a member of MTCR by removing the reference to India as only an “MTCR adherent” from paragraph (d) of § 742.5 of the EAR.
Footnote notations appear next to countries listed in the Commerce Country Chart in Supplement No. 1 to part 738 of the EAR that are subject to UNSC arms embargos. BIS removes that notation for Cote d'Ivoire and Liberia to conform to the termination of UNSC arms embargoes against those countries.
Although the Export Administration Act expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013) and as extended by the Notice of August 4, 2016, 81 FR 52587 (August 8, 2016), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act. BIS continues to carry out the provisions of the Export Administration Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222 as amended by Executive Order 13637.
1. Executive Orders 13563 and 12866 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, distribute impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been determined to be not significant for purposes of Executive Order 12866.
2. Notwithstanding any other provision of law, no person is required to respond to, nor is subject to a penalty for failure to comply with, a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
3. This rule does not contain policies with Federalism implications as that term is defined under E.O. 13132.
4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public participation, and a delay in effective date, are inapplicable because this regulation involves a military or foreign affairs function of the United States under 5 U.S.C. 553(a)(1). This final rule implements U.S. multilateral commitments pursuant to United Nations Security Council arms embargoes. The sanctions against Cote
Exports.
Administrative practice and procedure, Exports, Reporting and recordkeeping requirements.
Exports, Terrorism.
Exports, Reporting and recordkeeping requirements.
Accordingly, parts 738, 740, 742 and 746 of the Export Administration Regulations (15 CFR parts 730-774) are amended as follows:
Authority: 50 U.S.C. 4601
Authority: 50 U.S.C. 4601
50 U.S.C. 4601
50 U.S.C. 4601
Office of Foreign Assets Control, Treasury
Final rule.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is removing from the Code of Federal Regulations the Former Liberian Regime of Charles Taylor Sanctions Regulations as a result of the termination of the national emergency on which the regulations were based. OFAC also is amending the Reporting, Procedures and Penalties Regulations and Appendix A to chapter V by making technical changes including to remove references to OFAC's fax-on-demand service in order to reflect the discontinuation of that service.
The Department of the Treasury's Office of Foreign Assets Control: Assistant Director for Licensing, tel.: 202-622-2480, Assistant Director for Regulatory Affairs, tel.: 202-622-4855, Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490, or the Department of the Treasury's Office of the Chief Counsel (Foreign Assets Control), Office of the General Counsel, tel.: 202-622-2410.
This document and additional information concerning OFAC are available from OFAC's Web site (
On July 22, 2004, the President signed Executive Order 13348, “Blocking Property of Certain Persons and Prohibiting the Importation of Certain Goods from Liberia” (E.O. 13348), in which he declared a national emergency to deal with the unusual and extraordinary threat posed to United States foreign policy by the actions and policies of former Liberian President Charles Taylor and other persons, in particular their unlawful depletion of Liberian resources and their removal from Liberia and secreting of Liberian funds and property, which undermined Liberia's transition to democracy and the orderly development of its political, administrative, and economic institutions and resources. The President further noted that the Comprehensive Peace Agreement signed on August 18, 2003, and the related ceasefire had not yet been universally implemented throughout Liberia, and that the illicit trade in round logs and timber products was linked to the proliferation of and trafficking in illegal arms, which perpetuated the Liberian conflict and fueled and exacerbated other conflicts throughout West Africa.
E.O. 13348 blocked all property and interests in property of the persons listed in the Annex to E.O. 13348 and any person determined: (1) To be or have been an immediate family member of Charles Taylor; (2) to have been a senior official of the former Liberian regime headed by Charles Taylor or otherwise to have been or be a close ally or associate of Charles Taylor or the former Liberian regime; (3) to have materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services in support of, the unlawful depletion of Liberian resources, the removal of Liberian resources from that country, and the secreting of Liberian funds and property by any person whose property or interests in property are blocked pursuant to E.O. 13348; or (4) to be owned or controlled by, or acting or purporting to act for or on behalf of, directly or indirectly, any person whose property or interests in property are blocked pursuant to E.O. 13348. E.O. 13348 also prohibited the direct or indirect importation into the United States of any round log or timber product originating in Liberia.
On May 23, 2007, OFAC issued the Former Liberian Regime of Charles Taylor Sanctions Regulations, 31 CFR part 593, as a final rule to implement E.O. 13348 (72 FR 28855, May 23, 2007).
On November 12, 2015, the President issued Executive Order 13710, “Termination of Emergency With Respect to the Actions and Policies of Former Liberian President Charles Taylor” (E.O. 13710). In E.O. 13710, the President found that the situation that gave rise to the declaration of a national emergency in E.O. 13348 had been significantly altered by Liberia's significant advances to promote democracy and the orderly development of its political, administrative, and economic institutions, including presidential elections in 2005 and 2011, which were internationally recognized as freely held; the 2012 conviction of, and 50-year prison sentence for, former Liberian President Charles Taylor and the affirmation on appeal of that conviction and sentence; and the diminished ability of those connected to former Liberian President Charles Taylor to undermine Liberia's progress. As a result, he terminated the national emergency declared in E.O. 13348 and revoked that order.
Accordingly, OFAC is removing the Former Liberian Regime of Charles Taylor Sanctions Regulations from the Code of Federal Regulations. Pursuant to section 202 of the National Emergencies Act (50 U.S.C. 1622) and section 1 of E.O. 13710, termination of the national emergency declared in E.O. 13348 shall not affect any action taken or proceeding pending that was not fully concluded or determined as of 2:00 p.m. eastern standard time on November 12, 2015 (the effective date of E.O. 13710), any action or proceeding based on any act committed prior to the effective date, or any rights or duties that matured or penalties that were incurred prior to the effective date.
On June 10, 2016, OFAC announced on its Web site that it was terminating its fax-on-demand service due to a lack of user demand. OFAC is making technical changes to its regulations including to reflect the discontinuation of the fax-on-demand service.
The Reporting, Procedures and Penalties Regulations, 31 CFR part 501 (RPPR), set forth standard reporting and recordkeeping requirements and license application and other procedures relevant to the economic sanctions programs administered by OFAC. OFAC is revising section 501.603 of the RPPR, which covers reports on blocked property, and section 501.801 of the RPPR, which covers licensing, in each case to remove references to OFAC's fax-on-demand service and to make certain other technical changes.
Appendix A to chapter V (Appendix A) sets forth information pertaining to OFAC's Specially Designated Nationals and Blocked Persons List. OFAC is making two revisions to Appendix A, in each case to remove references to OFAC's fax-on-demand service.
Because parts 501 and 593 and Appendix A to 31 CFR chapter V involve a foreign affairs function, the provisions of Executive Order 12866 and the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, opportunity for public participation, and delay in effective date are inapplicable. Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.
Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the collections of information contained in the RPPR have been approved by the Office of Management and Budget under control number 1505-0164. 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 control number.
Administrative practice and procedure, Banks, Banking, Blocking of assets, Credit, Foreign trade, Imports, Liberia, Penalties, Reporting and recordkeeping requirements, Sanctions, Securities.
For the reasons set forth in the preamble, and under the authority of 3 U.S.C. 301; 50 U.S.C. 1601-1651; E.O. 13348, 69 FR 44885, 3 CFR, 2004 Comp., p. 189; E.O. 13710, 80 FR 71679, OFAC amends 31 CFR chapter V as follows:
8 U.S.C. 1189; 18 U.S.C. 2332d, 2339B; 19 U.S.C. 3901-3913; 21 U.S.C. 1901-1908; 22 U.S.C. 287c; 22 U.S.C. 2370(a), 6009, 6032, 7205; 28 U.S.C. 2461 note; 31 U.S.C. 321(b); 50 U.S.C. 1701-1706; 50 U.S.C. App. 1-44.
(b) * * *
(2) * * *
(ii) * * * Copies of Form TDF 90-22.50 may be obtained directly from the Office of Foreign Assets Control by downloading the form from the OFAC Reporting and License Application Forms page on OFAC's Web site (
(b) * * *
(2) * * * The form, which requires information regarding the date of the blocking, the financial institutions involved in the transfer, and the beneficiary and amount of the transfer, may be obtained from the OFAC Reporting and License Application Forms page on OFAC's Web site (
3 U.S.C. 301; 8 U.S.C. 1182, 1189; 18 U.S.C. 2339 B; 21 U.S.C. 1901-1908; 22 U.S.C. 287 c; 31 U.S.C. 321(b); 50 U.S.C. App. 1-44; Public Law 110-286, 122 Stat. 2632 (50 U.S.C. 1701 note); Public Law 111-195, 124 Stat. 1312 (22 U.S.C. 8501-8551); Public Law 112-81, 125 Stat. 1298 (22 U.S.C. 8513a); Public Law 112-158, 126 Stat. 1214 (22 U.S.C. 8701-8795); Public Law 112-208, 126 Stat. 1502; Public Law 113-278, 128 Stat. 3011 (50 U.S.C. 1701 note).
Financial Crimes Enforcement Network (“FinCEN”), Treasury.
Final rule.
FinCEN is issuing this final rule to make a number of technical amendments. This final rule updates various sections of the regulations implementing the Bank Secrecy Act (“BSA”) by removing or replacing outdated references to obsolete BSA forms, removing references to outdated recordkeeping storage media, and replacing several other outdated terms and references.
Effective November 4, 2016.
FinCEN Resource Center at 1-800-767-2825 or 1-703-905-3591 (not a toll free number) and select option 3 for regulatory questions. Email inquiries can be sent to
The BSA, Titles I and II of Public Law 91-508, as amended, codified at 12 U.S.C. 1829b, 12 U.S.C. 1951-1959, and 31 U.S.C. 5311-5314 and 5316-5332, authorizes the Secretary of the Treasury (“Secretary”), among other things, to issue regulations requiring persons to keep records and file reports that are determined to have a high degree of usefulness in criminal, tax, regulatory, and counter-terrorism matters. The regulations implementing the BSA appear at 31 CFR chapter X. The Secretary's authority to administer the BSA has been delegated to the Director of FinCEN.
In 2010, FinCEN reorganized the BSA's implementing regulations previously appearing in part 103 of title 31 of the Code of Federal Regulations by transferring them to a new chapter in title 31—chapter X.
A number of recordkeeping requirements in 31 CFR chapter X refer to the use of a type of data storage media—microfilm—that is no longer in wide use (or in many cases not even available) for copies of records required to be kept. This final rule removes those outdated references. If, however, a financial institution continues to use microfilm for copies, the rule change does not require the financial institution to use a different type of media for copies, nor does it require existing copies that were made on microfilm to be transferred to newer types of media.
Finally, this final rule replaces several other outdated terms or references where appropriate such as the reference to filing reports with the Commissioner of Internal Revenue (“IRS”). Effective July 1, 2011, all BSA reports are electronically filed with FinCEN, not the IRS.
Under 5 U.S.C. 553(b)(3)(B) of the Administrative Procedure Act (“APA”), an agency may, for good cause, find (and incorporate the finding and a brief statement of reasons in the rules issued)
Under 5 U.S.C. 553(d)(3) of the APA, the required publication or service of a substantive rule shall be made not less than 30 days before its effective date, except, among other things, as provided by the agency for good cause found and published with the rule. FinCEN finds that there is good cause for shortened notice since the revisions made by this final rule are minor, non-substantive, and technical. This final rule takes effect November 4, 2016.
The Regulatory Flexibility Act (“RFA”) does not apply to a rulemaking where a general notice of proposed rulemaking is not required.
FinCEN has determined that Executive Orders 13563 and 12866 do not apply to this final rulemaking.
There are no collection of information requirements in this final rule.
Section 202 of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1532 (“Unfunded Mandates Act”), requires that an agency must prepare a budgetary impact statement before promulgating any rule likely to result in a Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year. If a budgetary impact statement is required, section 205 of the Unfunded Mandates Act also requires an agency to identify and consider a reasonable number of regulatory alternatives before promulgating a rule. FinCEN has determined that no portion of this final rule will result in expenditures by State, local, and tribal governments, or by the private sector, of $100 million or more in any one year. Accordingly, this final rule is not subject to section 202 of the Unfunded Mandates Act.
Administrative practice and procedure, Banks, banking, Brokers, Currency, Foreign banking, Foreign currencies, Gambling, Investigations, Penalties, Reporting and recordkeeping requirements, Securities, Terrorism.
For the reasons set forth in the preamble, chapter X of title 31 of the Code of Federal Regulations is amended as follows:
12 U.S.C. 1829b and 1951-1959; 31 U.S.C. 5311-5314 and 5316-5332; title III, sec. 314, Pub. L. 107-56, 115 Stat. 307; sec. 701, Pub. L. 114-74, 129 Stat. 599.
12 U.S.C. 1829b and 1951-1959; 31 U.S.C. 5311-5314 and 5316-5332; title III, sec. 314, Pub. L. 107-56, 115 Stat. 307; sec. 701, Pub. L. 114-74, 129 Stat. 599.
12 U.S.C. 1829b and 1951-1959; 31 U.S.C. 5311-5314 and 5316-5332; title III, sec. 314, Pub. L. 107-56, 115 Stat. 307; sec. 701, Pub. L. 114-74, 129 Stat. 599.
12 U.S.C. 1829b and 1951-1959; 31 U.S.C. 5311-5314 and 5316-5332; title III,
12 U.S.C. 1829b and 1951-1959; 31 U.S.C. 5311-5314 and 5316-5332; title III, sec. 314, Pub. L. 107-56, 115 Stat. 307; sec. 701, Pub. L. 114-74, 129 Stat. 599.
12 U.S.C. 1829b and 1951-1959; 31 U.S.C. 5311-5314 and 5316-5332; title III, sec. 314, Pub. L. 107-56, 115 Stat. 307; sec. 701, Pub. L. 114-74, 129 Stat. 599.
12 U.S.C. 1829b and 1951-1959; 31 U.S.C. 5311-5314 and 5316-5332; title III, sec. 314, Pub. L. 107-56, 115 Stat. 307; sec. 701, Pub. L. 114-74, 129 Stat. 599.
12 U.S.C. 1829b and 1951-1959; 31 U.S.C. 5311-5314 and 5316-5332; title III, sec. 314, Pub. L. 107-56, 115 Stat. 307; sec. 701, Pub. L. 114-74, 129 Stat. 599.
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the Key West World Championship Special Local Regulation from 9:30 a.m. until 4:30 p.m. on November 9, 11, and 13, 2016. This action is necessary to ensure safety of life on navigable waters of the United States and to protect race participants, participant vessels, spectators, and the general public from the hazards associated with high-speed boat races. During the enforcement period, and in accordance with previously issued special local regulations, no person or vessel may enter the regulated area without permission from the Captain of the Port Key West or a designated representative.
The regulations in 33 CFR 100.701 will be enforced from 9:30 a.m. until 4:30 p.m. on November 9, 11, and 13, 2016, for the marine event listed in item (c)(9) in the Table to § 100.701.
If you have questions on this notice, call or email Lieutenant Scott Ledee, Sector Key West Waterways Management Department, Coast Guard; telephone (305) 292-8768, email
The Coast Guard will enforce the Special Local Regulation for the annual Key West World Championship Super Boat Race in Table to § 100.701, item (c)(9) from 9:30 a.m. until 4:30 p.m. on November 9, 11, and 13, 2016.
On November 9, 11, and 13, 2016, Super Boat International Productions,
Under the provisions of 33 CFR 100.701, no unauthorized person or vessel may enter, transit through, anchor within, or remain in the established regulated areas unless permission to enter has been granted by the Captain of the Port Key West or designated representative. This action is to provide enforcement action of regulated area that will encompass portions of the waters of the Atlantic Ocean located southwest of Key West, Florida. The Coast Guard may be assisted by other Federal, State, or local law enforcement agencies in enforcing this regulation.
This notice of enforcement is issued under authority of 33 CFR 100.701 and 5 U.S.C. 552(a). The Coast Guard will provide notice of the regulated area by Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives. If the Captain of the Port Key West determines that the regulated area need not be enforced for the full duration stated in this publication, he or she may use a Broadcast Notice to Mariners to grant general permission to enter the regulated area.
Coast Guard, DHS.
Notice of temporary deviation from regulations; request for comments.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the State Route 22 Bridge (Madisonville (SR22) swing span bridge) across the Tchefuncta River, mile 2.5, at Madisonville, St. Tammany Parish, Louisiana. This deviation will test a change to the drawbridge operation schedule to determine whether a permanent change to the schedule is needed. This deviation will allow the bridge to only open for vessels on the hour during the day and to not open for vessels during the weekday peak traffic hours.
This deviation is effective from 6 a.m. on November 21, 2016 through midnight on May 18, 2017.
Comments and related material must reach the Coast Guard on or before January 18, 2017.
You may submit comments identified by docket number USCG-2016-0963 using the Federal eRulemaking Portal at
If you have questions on this test deviation, call or email David Frank, Bridge Administrator at 504-671-2128, email
The State Route 22 (SR 22) swing span bridge across Tchefuncta River, mile 2.5, at Madisonville, St. Tammany Parish, Louisiana presently operates under 33 CFR 117.500. The SR 22 swing bridge has a vertical clearance of 6.2 feet above Mean High Water (MHW) in the closed-to-navigation position and unlimited clearance in the open-to-navigation position.
Local governmental officials from St. Tammany Parish and the City of Madisonville, in conjunction with the Louisiana Department of Transportation and Development (LDOTD) have requested that the operating regulation of the SR 22 swing span bridge be changed in order to better accommodate the increased vehicular traffic crossing the bridge especially during the peak, weekday rush hours. A traffic study conducted by the LDOTD has determined that the existing vehicular traffic at the intersection of SR 22 and SR 21/SR 1077 is over capacity at peak hours and causes unacceptable levels of delay to roadway traffic. This situation is compounded by the opening of the bridge during these peak hours. A combination of modifications to the operating schedule of the bridge and modifications to the traffic controls at this intersection will improve traffic flow and reduce traffic delays.
Approximately 7,500 vehicles cross the bridge daily between the hours of 6 a.m. and 7 p.m. Vessel openings for the month of July indicate that the bridge opened to pass vessels 118 times during the week and 202 times during the weekend. Vessel openings for the month of August dropped to 68 openings during the week and 85 openings during the weekend.
Concurrent with the publication of the Test Deviation, a Notice of Proposed Rulemaking (NPRM) [USCG-2016-0963] has been issued to allow the LDOTD to test the proposed schedule and to obtain data and public comments. The test period will be in effect during the entire NPRM comment period. The Coast Guard will review the logs of the drawbridge, the traffic counts provided by LDOTD, and evaluate public comments from this NPRM and the above referenced Temporary Deviation to determine if the requested change to the permanent special drawbridge operating regulation is warranted.
The deviation to test the proposed schedule will allow the SR 22 Bridge, mile 2.5 at Madisonville to operate as follows: The draw of the SR22 Bridge shall open on signal from 7 p.m. to 6 a.m. From 6 a.m. to 7 p.m., the draw need only open on the hour, except that the draw need not open for the passage of vessels at 8 a.m., 5 p.m. and 6 p.m. Monday through Friday except federal holidays. The bridge will open at any time an emergency.
During the 180-day deviation, LDOTD will continue to monitor vehicular traffic counts and work to make roadway traffic control improvements to further reduce vehicular traffic delays.
There are no alternate routes available for vessels that wish to transit the bridge site; however, if vessels have a vertical clearance requirement of less than 6.2 feet above MHW, they may transit the bridge site at any time.
We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Documents mentioned in this notice of temporary deviation from regulations, and all public comments, are in our online docket at
United States Patent and Trademark Office, Commerce.
Final rule.
The United States Patent and Trademark Office (USPTO) issues a final rule to incorporate classification changes adopted by the Nice Agreement Concerning the International Classification of Goods and Services for the Purposes of the Registration of Marks (Nice Agreement). These changes are effective January 1, 2017, and are listed in the International Classification of Goods and Services for the Purposes of the Registration of Marks (11th ed., ver. 2017), which is published by the World Intellectual Property Organization (WIPO).
This rule is effective on January 1, 2017.
Catherine Cain, Office of the Deputy Commissioner for Trademark Examination Policy, at (571) 272-8946 or
The Nice Agreement is a multilateral treaty, administered by WIPO, which establishes the international classification of goods and services for the purposes of registering trademarks and service marks. As of September 1, 1973, this international classification system is the controlling system used by the United States, and it applies to all applications filed on or after September 1, 1973, and their resulting registrations, for all statutory purposes. See 37 CFR 2.85(a). Every signatory to the Nice Agreement must utilize the international classification system.
Each state party to the Nice Agreement is represented in the Committee of Experts of the Nice Union (Committee of Experts), which meets annually to vote on proposed changes to the Nice Classification. Any state that is a party to the Nice Agreement may submit proposals for consideration by the other members in accordance with agreed-upon rules of procedure. Proposals are currently submitted on an annual basis to an electronic forum on the WIPO Web site, commented upon, modified, and compiled by WIPO for further discussion and voting at the annual Committee of Experts meeting.
In 2013, the Committee of Experts began annual revisions to the Nice Classification. The annual revisions, which are published electronically and enter into force on January 1 each year, are referred to as versions and identified by edition number and year of the effective date (
The annual revisions contained in this final rule consist of modifications to the class headings that have been incorporated into the Nice Agreement by the Committee of Experts. Under the Nice Classification, there are 34 classes of goods and 11 classes of services, each with a class heading. Class headings generally indicate the fields to which goods and services belong. Specifically, this rule adds new, or deletes existing, goods and services from 15 class headings and revises spelling in one class heading. The changes to the class headings further define the types of goods and/or services appropriate to the class. As a signatory to the Nice Agreement, the United States adopts these revisions pursuant to Article 1.
The USPTO is revising § 6.1 as follows:
In Class 3, the wording “soaps; perfumery, essential oils, cosmetics, hair lotions; dentifrices” is amended to “non-medicated soaps; perfumery, essential oils, non-medicated cosmetics, non-medicated hair lotions; non-medicated dentifrices.”
In Class 6, the wording “Common metals and their alloys” is amended to “Common metals and their alloys, ores,” and the separate clause “ores” at the end of the class heading is deleted. The wording “metal building materials” is amended to “metal materials for building and construction.” The wording “materials of metal for railway tracks,” “ironmongery,” and “pipes and tubes of metal” is deleted. The wording “metal containers for storage or transport” is inserted before “safes.”
In Class 10, the spelling of “orthopedic” is amended to “orthopaedic.” A semi-colon is added after the wording “suture materials,” and the following wording is added: “therapeutic and assistive devices adapted for the disabled; massage apparatus; apparatus, devices and articles for nursing infants; sexual activity apparatus, devices and articles.”
The wording “precious stones” is amended to “precious and semi-precious stones” in Class 14.
In Class 16, the wording “and office requisites, except furniture” is added
In Class 17, the wording “plastics in extruded form for use in manufacture” is amended to “plastics and resins in extruded form for use in manufacture.” The wording “flexible pipes, not of metal” is changed to “flexible pipes, tubes and hoses, not of metal.”
In Class 18, “animal skins, hides” is amended to “animal skins and hides,” and “trunks and travelling bags” is amended to “luggage and carrying bags.” A semi-colon is added after the term “saddlery,” and the wording “collars, leashes and clothing for animals” is added thereafter.
The wording “containers, not of metal, for storage or transport” is added in Class 20 after “Furniture, mirrors, picture frames.” The term “ivory” is deleted.
“[B]rushes (except paintbrushes)” is amended to “brushes, except paintbrushes” in Class 21. The term “steelwool” is deleted. The wording “unworked or semi-worked glass (except glass used in building)” is amended to “unworked or semi-worked glass, except building glass.”
In Class 22, “tents, awnings, and tarpaulins” is amended to “tents and tarpaulins; awnings of textile or synthetic materials.” The wording “sacks” is amended to “sacks for the transport and storage of materials in bulk,” and “padding and stuffing materials (except of paper, cardboard, rubber or plastics)” is changed to “padding, cushioning and stuffing materials, except of paper, cardboard, rubber or plastics.” The wording “and substitutes therefor” is inserted after “raw fibrous textile materials.”
The wording “bed covers; table covers” is deleted, and the wording “household linen; curtains of textile or plastic” is inserted after “Textiles and substitutes for textiles” in Class 24.
In Class 26, the wording “hair decorations; false hair” is added.
“Games and playthings” in Class 28 is changed to “Games, toys and playthings,” and the wording “video game apparatus” is added.
In Class 31, the wording “Agricultural, horticultural and forestry products” is amended to “Raw and unprocessed agricultural, aquacultural, horticultural and forestry products,” and “fresh fruits and vegetables” is amended to “fresh fruits and vegetables, fresh herbs.” The wording “bulbs, seedlings and seeds for planting” is inserted after “natural plants and flowers.” “[F]oodstuffs for animals” is amended to “foodstuffs and beverages for animals.”
“[S]ecurity services for the protection of property and individuals” is amended to “security services for the physical protection of tangible property and individuals” in Class 45.
Accordingly, prior notice and opportunity for public comment for the changes in this rulemaking are not required pursuant to 5 U.S.C. 553(b) or (c), or any other law.
Administrative practice and procedure, Classification, Trademarks.
For the reasons given in the preamble and under the authority contained in 15 U.S.C. 1112, 1123 and 35 U.S.C. 2, as amended, the USPTO is amending part 6 of title 37 as follows:
Secs. 30, 41, 60 Stat. 436, 440; 15 U.S.C. 1112, 1123; 35 U.S.C. 2, unless otherwise noted.
1. Chemicals used in industry, science and photography, as well as in agriculture, horticulture and forestry; unprocessed artificial resins, unprocessed plastics; manures; fire extinguishing compositions; tempering and soldering preparations; chemical substances for preserving foodstuffs; tanning substances; adhesives used in industry.
2. Paints, varnishes, lacquers; preservatives against rust and against deterioration of wood; colorants; mordants; raw natural resins; metals in foil and powder form for use in painting, decorating, printing and art.
3. Bleaching preparations and other substances for laundry use; cleaning, polishing, scouring and abrasive preparations; non-medicated soaps; perfumery, essential oils, non-medicated cosmetics, non-medicated hair lotions; non-medicated dentifrices.
4. Industrial oils and greases; lubricants; dust absorbing, wetting and binding compositions; fuels (including motor spirit) and illuminants; candles and wicks for lighting.
5. Pharmaceuticals, medical and veterinary preparations; sanitary preparations for medical purposes; dietetic food and substances adapted for medical use or veterinary use, food for babies; dietary supplements for humans and animals; plasters, materials for dressings; material for stopping teeth, dental wax; disinfectants; preparations for destroying vermin; fungicides, herbicides.
6. Common metals and their alloys, ores; metal materials for building and construction; transportable buildings of metal; non-electric cables and wires of common metal; small items of metal hardware; metal containers for storage or transport; safes.
7. Machines and machine tools; motors and engines (except for land vehicles); machine coupling and transmission components (except for land vehicles); agricultural implements other than hand-operated; incubators for eggs; automatic vending machines.
8. Hand tools and implements (hand-operated); cutlery; side arms; razors.
9. Scientific, nautical, surveying, photographic, cinematographic, optical, weighing, measuring, signalling, checking (supervision), life-saving and teaching apparatus and instruments; apparatus and instruments for conducting, switching, transforming, accumulating, regulating or controlling electricity; apparatus for recording, transmission or reproduction of sound or images; magnetic data carriers, recording discs; compact discs, DVDs and other digital recording media; mechanisms for coin-operated apparatus; cash registers, calculating machines, data processing equipment, computers; computer software; fire-extinguishing apparatus.
10. Surgical, medical, dental and veterinary apparatus and instruments; artificial limbs, eyes and teeth; orthopaedic articles; suture materials; therapeutic and assistive devices adapted for the disabled; massage apparatus; apparatus, devices and articles for nursing infants; sexual activity apparatus, devices and articles.
11. Apparatus for lighting, heating, steam generating, cooking, refrigerating, drying, ventilating, water supply and sanitary purposes.
12. Vehicles; apparatus for locomotion by land, air or water.
13. Firearms; ammunition and projectiles; explosives; fireworks.
14. Precious metals and their alloys; jewellery, precious and semi-precious stones; horological and chronometric instruments.
15. Musical instruments.
16. Paper and cardboard; printed matter; bookbinding material; photographs; stationery and office requisites, except furniture; adhesives for stationery or household purposes; artists' and drawing materials; paintbrushes; instructional and teaching materials; plastic sheets, films and bags for wrapping and packaging; printers' type, printing blocks.
17. Unprocessed and semi-processed rubber, gutta-percha, gum, asbestos, mica and substitutes for all these materials; plastics and resins in extruded form for use in manufacture; packing, stopping and insulating materials; flexible pipes, tubes and hoses, not of metal.
18. Leather and imitations of leather; animal skins and hides; luggage and carrying bags; umbrellas and parasols; walking sticks; whips, harness and saddlery; collars, leashes and clothing for animals.
19. Building materials (non-metallic); non-metallic rigid pipes for building; asphalt, pitch and bitumen; non-metallic transportable buildings; monuments, not of metal.
20. Furniture, mirrors, picture frames; containers, not of metal, for storage or transport; unworked or semi-worked bone, horn, whalebone or mother-of-pearl; shells; meerschaum; yellow amber.
21. Household or kitchen utensils and containers; combs and sponges; brushes, except paintbrushes; brush-making materials; articles for cleaning purposes; unworked or semi-worked glass, except building glass; glassware, porcelain and earthenware.
22. Ropes and string; nets; tents and tarpaulins; awnings of textile or synthetic materials; sails; sacks for the transport and storage of materials in bulk; padding, cushioning and stuffing materials, except of paper, cardboard, rubber or plastics; raw fibrous textile materials and substitutes therefor.
23. Yarns and threads, for textile use.
24. Textiles and substitutes for textiles; household linen; curtains of textile or plastic.
25. Clothing, footwear, headgear.
26. Lace and embroidery, ribbons and braid; buttons, hooks and eyes, pins and needles; artificial flowers; hair decorations; false hair.
27. Carpets, rugs, mats and matting, linoleum and other materials for covering existing floors; wall hangings (non-textile).
28. Games, toys and playthings; video game apparatus; gymnastic and sporting articles; decorations for Christmas trees.
29. Meat, fish, poultry and game; meat extracts; preserved, frozen, dried and cooked fruits and vegetables; jellies, jams, compotes; eggs; milk and milk products; edible oils and fats.
30. Coffee, tea, cocoa and artificial coffee; rice; tapioca and sago; flour and preparations made from cereals; bread, pastries and confectionery; edible ices; sugar, honey, treacle; yeast, baking-powder; salt; mustard; vinegar, sauces (condiments); spices; ice.
31. Raw and unprocessed agricultural, aquacultural, horticultural and forestry products; raw and unprocessed grains and seeds; fresh fruits and vegetables, fresh herbs; natural plants and flowers; bulbs, seedlings and seeds for planting; live animals; foodstuffs and beverages for animals; malt.
32. Beers; mineral and aerated waters and other non-alcoholic beverages; fruit beverages and fruit juices; syrups and other preparations for making beverages.
33. Alcoholic beverages (except beers).
34. Tobacco; smokers' articles; matches.
35. Advertising; business management; business administration; office functions.
36. Insurance; financial affairs; monetary affairs; real estate affairs.
37. Building construction; repair; installation services.
38. Telecommunications.
39. Transport; packaging and storage of goods; travel arrangement.
40. Treatment of materials.
41. Education; providing of training; entertainment; sporting and cultural activities.
42. Scientific and technological services and research and design relating thereto; industrial analysis and research services; design and development of computer hardware and software.
43. Services for providing food and drink; temporary accommodation.
44. Medical services; veterinary services; hygienic and beauty care for human beings or animals; agriculture, horticulture and forestry services.
45. Legal services; security services for the physical protection of tangible property and individuals; personal and social services rendered by others to meet the needs of individuals.
Federal Emergency Management Agency, DHS.
Final rule.
This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the
The effective date of each community's scheduled suspension is the third date (“Susp.”) listed in the third column of the following tables.
If you want to determine whether a particular community was suspended on the suspension date or for further information, contact Patricia Suber, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 400 C Street SW., Washington, DC 20472, (202) 646-4149.
The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale of NFIP flood insurance unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. We recognize that some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue to be eligible for the sale of NFIP flood insurance. A notice withdrawing the suspension of such communities will be published in the
In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that identifies the Special Flood Hazard Areas (SFHAs) in these communities. The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year on FEMA's initial FIRM for the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment procedures under 5 U.S.C. 553(b), are impracticable and unnecessary because communities listed in this final rule have been adequately notified.
Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.
Flood insurance, Floodplains.
Accordingly, 44 CFR part 64 is amended as follows:
42 U.S.C. 4001
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS closes the coastwide General category fishery for large medium and giant Atlantic bluefin tuna (BFT) for 2016. This action is being taken to prevent any further overharvest of the available adjusted General category quota of 676.7 metric tons (mt).
Effective 11:30 p.m., local time, November 4, 2016, through December 31, 2016.
Sarah McLaughlin or Brad McHale, 978-281-9260.
Regulations implemented under the authority of the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971
NMFS is required, under § 635.28(a)(1), to file a closure notice with the Office of the Federal Register for publication when a BFT quota is reached or is projected to be reached. On and after the effective date and time of such notification, for the remainder of the fishing year or for a specified period as indicated in the notification, retaining, possessing, or landing BFT under that quota category is prohibited until the opening of the subsequent quota period or until such date as specified in the notice.
The base quota for the General category is 466.7 mt. See § 635.27(a). To date this year, NMFS has adjusted the General category base quota for 2016 twice, including a transfer of 125 mt from the Reserve category effective October 6 (81 FR 70369, October 12, 2016), and a transfer of 85 mt (18 mt from the Harpoon category quota and 67 mt from the Reserve category) effective October 14 (81 FR 71639, October 18, 2016), resulting in an adjusted quota of 676.7 mt.
Based on the best available landings information for the General category BFT fishery, NMFS has determined that the adjusted General category quota of 676.7 mt has been reached (
Fishermen may catch and release (or tag and release) BFT of all sizes, subject to the requirements of the catch-and-release and tag-and-release programs at § 635.26. Anglers are also reminded that all BFT that are released must be handled in a manner that will maximize survival, and without removing the fish from the water, consistent with requirements at § 635.21(a)(1). For additional information on safe handling, see the “Careful Catch and Release” brochure available at
The Assistant Administrator for NMFS (AA) finds that it is impracticable and contrary to the public interest to provide prior notice of, and an opportunity for public comment on, this action for the following reasons:
The regulations implementing the 2006 Consolidated HMS FMP and amendments provide for inseason retention limit adjustments and fishery closures to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. These fisheries are currently underway and delaying this action would be contrary to the public interest as it could result in excessive BFT landings that may result in future potential quota reductions for the General category. NMFS must close the General category fishery for 2016 to prevent the available quota from being exceeded any further. Therefore, the AA finds good cause under 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment. For all of the above reasons, there is good cause under 5 U.S.C. 553(d) to waive the 30-day delay in effectiveness.
This action is being taken under § 635.28(a)(1), and is exempt from review under Executive Order 12866.
16 U.S.C. 971
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; reallocation.
NMFS is exchanging unused flathead sole and rock sole Amendment 80 allocations of the total allowable catch for yellowfin sole Amendment 80 acceptable biological catch (ABC) reserves. This action is necessary to allow the 2016 total allowable catch of flathead sole, rock sole, and yellowfin sole in the Bering Sea and Aleutian Islands management area to be harvested.
Effective November 4, 2016, through December 31, 2016.
Steve Whitney, 907-586-7228.
NMFS manages the groundfish fishery in the Bering Sea and Aleutian Islands management area (BSAI) according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The 2016 flathead sole, rock sole, and yellowfin sole Amendment 80 allocations of the total allowable catch (TAC) specified in the BSAI are 9,853 metric tons (mt), 43,965 mt, and 115,038 mt as established by the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016) and as revised (81 FR 75740, November 1, 2016). The 2016 flathead sole, rock sole, and yellowfin sole Amendment 80 ABC reserves are 44,308 mt, 93,897 mt, and 55,531 mt as established by the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016).
The Alaska Seafood cooperative has requested that NMFS exchange 850 mt of flathead sole and 1,670 mt of rock sole Amendment 80 allocations of the TAC for 2,520 mt of yellowfin sole Amendment 80 ABC reserves under § 679.91(i). Therefore, in accordance with § 679.91(i), NMFS exchanges 850 mt of flathead sole and 1,670 mt of rock sole Amendment 80 allocations of the TAC for 2,520 mt of yellowfin sole Amendment 80 ABC reserves in the BSAI. This action also decreases and increases the TACs and Amendment 80 ABC reserves by the corresponding amounts. Tables 11 and 13 of the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016) and as revised (81 FR 75740, November 1, 2016) are further revised as follows:
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the flatfish exchange by the Alaska Seafood cooperative the BSAI. Since these fisheries are currently open, it is important to immediately inform the industry as to the revised allocations. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery, to allow the industry to plan for the fishing season, and to avoid potential disruption to the fishing fleet as well as processors. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of October 25, 2016.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Notice of proposed rulemaking.
On July 1, 2016, the U.S. Department of Energy (DOE) published a final rule adopting a test procedure for integrated light-emitting diode (LED) lamps (hereafter referred to as “LED lamps”) to support the implementation of labeling provisions by the Federal Trade Commission, as well as the ongoing general service lamps rulemaking, which includes LED lamps. This notice of proposed rulemaking (NOPR) proposes to amend the LED lamps test procedure by allowing for time to failure measurements to be taken at elevated temperatures.
DOE will accept comments, data, and information regarding this NOPR no later than December 5, 2016. See section V, “Public Participation,” for details.
Any comments submitted must identify the Test Procedure NOPR for Integrated LED Lamps, and provide docket number EERE-2016-BT-TP-0037 and/or regulatory information number (RIN) 1904-AD74. Comments may be submitted using any of the following methods:
1.
2.
3.
4.
For detailed instructions on submitting comments and additional information on the rulemaking process, see section V of this NOPR, “Public Participation.”
The docket, which includes
A link to the docket Web page can be found at
Ms. Lucy deButts, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE-2J, 1000 Independence Avenue SW., Washington, DC, 20585-0121. Telephone: (202) 287-1604. Email:
Ms. Celia Sher, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW., Washington, DC, 20585-0121. Telephone: (202) 287-6122. Email:
Title III of the Energy Policy and Conservation Act of 1975 (42 U.S.C. 6291,
Under EPCA, the energy conservation program consists essentially of four parts: (1) Testing, (2) labeling, (3) Federal energy conservation standards, and (4) certification and enforcement procedures. The testing requirements consist of test procedures that manufacturers of covered products must use as the basis for (1) certifying to DOE that their products comply with the applicable energy conservation standards adopted under EPCA (42
Under 42 U.S.C. 6293, EPCA sets forth the criteria and procedures DOE must follow when prescribing or amending test procedures for covered products. EPCA provides, in relevant part, that any test procedures prescribed or amended under this section shall be reasonably designed to produce test results which measure energy efficiency, energy use or estimated annual operating cost of a covered product during a representative average use cycle or period of use and shall not be unduly burdensome to conduct. (42 U.S.C. 6293(b)(3))
In addition, if DOE determines that a test procedure amendment is warranted, it must publish proposed test procedures and offer the public an opportunity to present oral and written comments on them. (42 U.S.C. 6293(b)(2)) Finally, in any rulemaking to amend a test procedure, DOE must determine to what extent, if any, the proposed test procedure would alter the measured energy efficiency of any covered product as determined under the existing test procedure. (42 U.S.C. 6293(e)(1)) If DOE determines that the amended test procedure would alter the measured efficiency of a covered product, DOE must amend the applicable energy conservation standard accordingly. (42 U.S.C. 6293(e)(2))
DOE published a final rule in the
In this NOPR, DOE proposes to amend the test procedures for integrated LED lamps with regard to the time to failure test method. Based on stakeholder feedback since the publication of the July 2016 LED TP final rule, DOE is proposing to allow time to failure measurements collected for DOE's LED lamps test procedure to be taken at elevated temperatures.
Any amended test procedure adopted in this rulemaking will be effective as the applicable DOE test procedure beginning 30 days after publication of a final rule in the
EPCA defines an LED as a p-n junction
The ANSI/IES standard defines an integrated LED lamp as an integrated assembly that comprises LED packages (components) or LED arrays (modules) (collectively referred to as an LED source), an LED driver, an ANSI standard base, and other optical, thermal, mechanical and electrical components (such as phosphor layers, insulating materials, fasteners to hold components within the lamp together, and electrical wiring). The LED lamp is intended to connect directly to a branch circuit through a corresponding ANSI standard socket. 81 FR 43403, 43405 (July 1, 2016). This NOPR proposes to amend the test procedures for integrated LED lamps.
In the July 2016 LED TP final rule, DOE adopted test procedures, located in appendix BB to subpart B of 10 CFR part 430, for measuring and projecting time to failure of LED lamps based on lumen maintenance data. The adopted test procedures were largely based on the industry standards IES LM-84-14, “Approved Method: Measuring Luminous Flux and Color Maintenance of LED Lamps, Light Engines, and Luminaires,” and IES TM-28-14, “Projecting Long-Term Luminous Flux Maintenance of LED Lamps and Luminaires,” for the applicable lumen maintenance measurements and time to failure projection methods, with some modifications. 81 FR 43403, 43427-43428 (July 1, 2016). IES LM-84-14 provides a method for lumen maintenance measurement of integrated LED lamps and specifies the operational and environmental conditions during testing such as operating cycle, ambient temperature, airflow, and orientation. Lumen maintenance is the measure of lumen output after an elapsed operating time, expressed as a percentage of the initial lumen output. IES TM-28-14 provides methods for projecting the lumen maintenance of integrated LED lamps depending on the available data and test duration. The provided methods include projecting time to failure using multiple lumen maintenance measurements collected over a period of time, rather than a single measurement at the end of the test duration. 81 FR at 43409 (July 1, 2016). The adopted test procedure requires that the projection calculation be completed for each individual LED lamp and the projected time to failure values then be used to calculate the lifetime of the sample using the prescribed methods. 81 FR at 43414 (July 1, 2016). The lumen maintenance measurements used in the projection are to be taken at an ambient temperature of 25 °C ± 5 °C.
Since the publication of the July 2016 LED TP final rule, DOE received a request from the National Electrical Manufacturers Association (NEMA) to approve the use of test results from the Elevated Temperature Life Test
DOE agrees that the operating temperature test conditions specified in the ENERGY STAR Elevated Temperature Life Test will more negatively affect performance values than those prescribed in DOE's LED lamps test procedure since the Elevated Temperature Life Test requires testing of LED lamps at higher ambient temperatures. Specifically, the Elevated Temperature Life Test requires directional lamps with rated wattages less than or equal to 20 W to be tested at 45 °C ± 5 °C; directional lamps with rated wattages greater than 20 W to be tested at 55 °C ± 5 °C; and all other omnidirectional and decorative lamps to be tested at 45 °C ± 5 °C. DOE's test procedure requires operating temperature to be maintained at 25 °C ± 5 °C. The Elevated Temperature Life Test applies only to lamps that do not have a “not for use in totally enclosed or recessed luminaires” statement (or an equivalent statement) on the lamp label.
In addition to a difference in ambient temperature during lumen maintenance testing, ENERGY STAR's and DOE's test procedures also differ in how to determine the value of lifetime. ENERGY STAR's test procedure provides a method to confirm a manufacturer-declared lifetime value. It requires manufacturers to meet or exceed minimum lumen maintenance values at a specific test duration to be able to claim a certain maximum lifetime. For example, for a lamp to be certified with a lifetime of 25,000 hours, that lamp must achieve a minimum lumen maintenance of 91.8% after 6,000 hours of operation. DOE's test procedure for determining lifetime depends on the time to failure of individual units, which is determined by taking lumen maintenance measurements at multiple intervals and then calculating the time to failure. For example, after 6,000 hours of testing, manufacturers can use the specified method to project a lamp's time to failure value to be up to 36,000 hours. Lifetime is then determined by calculating the median time to failure of the sample (calculated as the arithmetic mean of the time to failure of the two middle sample units when the numbers are sorted in value order). This is consistent with the statutory definition of lifetime, which is described as the length of operating time of a statistically large group of lamps between first use and failure of 50 percent of the group. 42 U.S.C. 6291(30)(P).
To maintain consistency with the statutory definition of lifetime, DOE is not allowing for an entire substitution of the ENERGY STAR lifetime test procedure in place of DOE's time to failure measurements. Instead, DOE is proposing in this NOPR to amend section 4.4.4 of appendix BB to allow time to failure testing to be conducted at elevated temperatures above the current requirement, which stipulates to maintain ambient operating temperature at 25 °C ± 5 °C. Manufacturers would then have the flexibility to conduct the Elevated Temperature Life Test for ENERGY STAR, while also following the calculation method for DOE's LED lamps test procedure, and avoid test duplication. LED lamps are sensitive to changes in ambient temperature, generally performing less favorably at higher temperatures. DOE believes this proposed change will result in, if any difference, more conservative representations of lifetime.
DOE requests comment on the proposed amendment to the integrated LED lamps test procedure to allow testing for time to failure, as prescribed in section 4 of appendix BB to subpart B of 10 CFR part 430, to be conducted at elevated temperatures.
If adopted, the effective date for the proposed test procedure amendments would be 30 days after publication of the final rule in the
The Office of Management and Budget (OMB) has determined that test procedure rulemakings do not constitute “significant regulatory actions” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, 58 FR 51735 (Oct. 4, 1993). Accordingly, this action was not subject to review under the Executive Order by the Office of Information and Regulatory Affairs (OIRA) in the OMB.
The Regulatory Flexibility Act (5 U.S.C. 601
DOE reviewed the amended test procedures for LED lamps proposed in this NOPR under the provisions of the Regulatory Flexibility Act (RFA) and the procedures and policies published on February 19, 2003. DOE certifies that the proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The factual basis for this certification is set forth in the following paragraphs.
The Small Business Administration (SBA) considers a business entity to be a small business, if, together with its affiliates, it employs less than a threshold number of workers specified in 13 CFR part 121. These size standards and codes are established by the North American Industry Classification System (NAICS). Manufacturing of LED lamps is classified under NAICS 335110, “Electric Lamp Bulb and Part Manufacturing.” The SBA sets a threshold of 1,250 employees or less for an entity to be considered as a small business for this category.
To estimate the number of companies that could be small businesses that sell LED lamps covered by this rulemaking, DOE conducted a market survey using publicly available information. DOE's research involved information from the Environmental Protection Agency's ENERGY STAR Certified Light Bulbs Database,
DOE notes that this proposed rule merely seeks to amend the existing LED test procedure in a way that would reduce test burden on manufacturers. The proposed amendment would reduce the instances in which two tests for lifetime must be conducted for the same lamp. In addition, the proposal is supported by industry, including NEMA. Manufacturers that would seek to test time to failure at elevated temperatures under the proposed amendment, if adopted, are likely to have previously accounted for testing costs associated with the ENERGY STAR program as these measurements are required to be reported to ENERGY STAR if manufacturers certify the lamps as meeting the program requirements. For manufacturers who do not test products at elevated temperatures, this proposed amendment presents no additional burden.
For these reasons, DOE tentatively concludes and certifies that the proposed amendment in this NOPR would not have a significant economic impact on a substantial number of small entities, and the preparation of an IRFA is not warranted. DOE will transmit the certification and supporting statement of factual basis to the Chief Counsel for Advocacy of the SBA for review under 5 U.S.C. 605(b).
Manufacturers of LED lamps must certify to DOE that their products comply with any applicable energy conservation standards. To certify compliance, manufacturers must first obtain test data for their products according to the DOE test procedures, including any amendments adopted for those test procedures. DOE has established regulations for the certification and recordkeeping requirements for all covered consumer products and commercial equipment, including LED lamps. (See generally 10 CFR part 429.) The collection-of-information requirement for the certification and recordkeeping is subject to review and approval by OMB under the Paperwork Reduction Act (PRA). This requirement has been approved by OMB under OMB control number 1910-1400. Public reporting burden for the certification is estimated to average 30 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
Notwithstanding any other provision of the law, no person is required to respond to, nor must any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB control number.
In this proposed rule, DOE is proposing an amendment to the test procedure for LED lamps that will be used to support the ongoing general service lamps energy conservation standards rulemaking as well as the FTC's Lighting Facts labeling program. DOE has determined that this rule falls into a class of actions that are categorically excluded from review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Executive Order 13132, “Federalism,” 64 FR 43255 (August 4, 1999), imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have Federalism implications. The Executive Order requires agencies to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and to carefully assess the necessity for such actions. The Executive Order also requires agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have Federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of such regulations. 65 FR 13735. DOE has examined this proposed rule and has determined that it 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. EPCA governs and prescribes Federal preemption of State regulations as to energy conservation for the products that are the subject of this proposed rule. States can petition DOE for exemption from such preemption to the extent, and based on criteria, set forth in EPCA. (42 U.S.C. 6297(d)) No further action is required by Executive Order 13132.
Regarding the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4729 (Feb. 7, 1996), imposes on Federal agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity, (2) write regulations to minimize litigation, (3) provide a clear legal standard for affected conduct rather than a general standard, and (4) promote simplification and burden reduction. Section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation (1) clearly specifies the preemptive effect, if any, (2) clearly specifies any effect on existing Federal law or regulation, (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction, (4) specifies the retroactive effect, if any, (5) adequately defines key terms, and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in sections 3(a) and 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, the proposed rule meets the relevant standards of Executive Order 12988.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and Tribal governments and the private sector. Public Law 104-4, sec. 201 (codified at 2 U.S.C. 1531). For a proposed regulatory action resulting in a rule that may cause the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b)) The UMRA also requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and Tribal governments on a proposed “significant intergovernmental mandate,” and requires an agency plan for giving notice and opportunity for timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect small governments. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA. 62 FR 12820; also available at
Section 654 of the Treasury and General Government Appropriations Act, 1999 (Public Law 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any rule that may affect family well-being. This rule would not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.
DOE has determined, under Executive Order 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights” 53 FR 8859 (March 18, 1988), that this regulation would not result in any takings that might require compensation under the Fifth Amendment to the U.S. Constitution.
Section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note) provides for agencies to review most disseminations of information to the public under guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (Feb. 22, 2002), and DOE's guidelines were published at 67 FR 62446 (Oct. 7, 2002). DOE has reviewed this proposed rule under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.
Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to OMB, a Statement of Energy Effects for any significant energy action. A “significant energy action” is defined as any action by an agency that promulgated or is expected to lead to promulgation of a final rule, and that (1) is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy; or (3) is designated by the Administrator of OIRA as a significant energy action. For any proposed significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use if the regulation is implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use.
This regulatory action to propose an amended test procedure for measuring the lumen maintenance and time to failure of LED lamps is not a significant regulatory action under Executive Order 12866. Moreover, it would not have a significant adverse effect on the supply, distribution, or use of energy, nor has it been designated as a significant energy action by the Administrator of OIRA. Therefore, it is not a significant energy action, and, accordingly, DOE has not prepared a Statement of Energy Effects.
Under section 301 of the Department of Energy Organization Act (Public Law 95-91; 42 U.S.C. 7101), DOE must comply with section 32 of the Federal Energy Administration Act of 1974, as amended by the Federal Energy Administration Authorization Act of 1977. (15 U.S.C. 788; FEAA) Section 32 essentially provides in relevant part that, where a proposed rule authorizes or requires use of commercial standards, the notice of proposed rulemaking must inform the public of the use and background of such standards. In addition, section 32(c) requires DOE to consult with the Attorney General and the Chairman of the Federal Trade Commission (FTC) concerning the impact of the commercial or industry standards on competition.
The proposed amendment to the test procedures for LED lamps in this NOPR does not incorporate any new standards that would require compliance under section 32(b) of the FEAA.
DOE will accept comments, data, and information regarding this proposed rule no later than the date provided in the
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Include contact information each time you submit comments, data, documents, and other information to DOE. If you submit via mail or hand delivery, please provide all items on a CD, if feasible. It is not necessary to submit printed copies. No facsimiles (faxes) will be accepted.
Comments, data, and other information submitted to DOE electronically should be provided in PDF (preferred), Microsoft Word or Excel, WordPerfect, or text (ASCII) file format. Provide documents that are not secured, written in English and free of any defects or viruses. Documents should not contain special characters or any form of encryption and, if possible, they should carry the electronic signature of the author.
Factors of interest to DOE when evaluating requests to treat submitted information as confidential include: (1) A description of the items; (2) whether and why such items are customarily treated as confidential within the industry; (3) whether the information is generally known by or available from other sources; (4) whether the information has previously been made available to others without obligation concerning its confidentiality; (5) an explanation of the competitive injury to the submitting person which would result from public disclosure; (6) when such information might lose its confidential character due to the passage of time; and (7) why disclosure of the information would be contrary to the public interest.
It is DOE's policy that all comments may be included in the public docket, without change and as received, including any personal information provided in the comments (except information deemed to be exempt from public disclosure).
Although comments are welcome on all aspects of this proposed rulemaking, DOE is particularly interested in comments on the proposed amendment to the integrated LED lamps test procedure to allow for testing to be conducted at elevated temperatures during time to failure tests as prescribed in section 4 of appendix BB to subpart B of 10 CFR part 430.
The Secretary of Energy has approved publication of this proposed rule.
Administrative practice and procedure, Confidential business information, Energy conservation, Household appliances, Imports, Incorporation by reference, Intergovernmental relations, Small businesses.
For the reasons stated in the preamble, DOE proposes to amend part 430 of Chapter II of Title 10, Code of Federal Regulations as set forth below:
42 U.S.C.6291-6309; 28 U.S.C. 2461 note.
Note: On or after [
4.4.4. Ambient temperature conditions must be as described in section 4.4 of IES LM-84. Maintain the ambient temperature at 25 °C ± 5 °C or at a manufacturer-selected temperature higher than 25 °C with the same ± 5 °C tolerance.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for Pilatus Aircraft Ltd. Models PC-6, PC-6-H1, PC-6-H2, PC-6/350, PC-6/350-H1, PC-6/350-H2, PC-6/A, PC-6/A-H1, PC-6/A-H2, PC-6/B-H2, PC-6/B1-H2, PC- 6/B2-H2, PC-6/B2-H4, PC-6/C-H2, and PC-6/C1-H2 airplanes. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as certain combinations of the aileron counterweight and the attaching parts possibly resulting in reduced thread engagement and leading to disconnection of the aileron counterweight from the aileron. We are issuing this proposed AD to require actions to address the unsafe condition on these products.
We must receive comments on this proposed AD by December 19, 2016.
You may send comments by any of the following methods:
•
•
•
•
For service information identified in this proposed AD, contact Pilatus Aircraft Ltd., Customer Technical Support (MCC), P.O. Box 992, CH-6371 Stans, Switzerland; phone: +41 (0)41 619 3333; fax: +41 (0)41 619 7311; email:
You may examine the AD docket on the Internet at
Doug Rudolph, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4059; fax: (816) 329-4090; email:
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued AD No.: 2016-0183, dated September 13, 2016 (referred to after this as “the MCAI”), to correct an unsafe condition for Pilatus Aircraft Ltd. Model PC-6, PC-6-H1, PC-6-H2, PC-6/350, PC-6/350-H1, PC-6/350-H2, PC-6/A, PC-6/A-H1, PC-6/A-H2, PC-6/B-H2, PC-6/B1-H2, PC- 6/B2-H2, PC-6/B2-H4, PC-6/C-H2, and PC-6/C1-H2 airplanes and was based on mandatory continuing airworthiness information originated by an aviation authority of another country. The MCAI states:
The proper installation of the aileron counterweight requires a combination, peculiar to each aileron, of anchor nut types, bolt types, number of washers, and the definition of the bolt torque. Some combinations of counterweight and attaching parts, which could result in reduced thread engagement, have been reported on a PC-6 aeroplane.
This condition, if not detected and corrected, may lead to a disconnection of the aileron counterweight from the aileron, possibly resulting in reduced control of the aeroplane.
To address this potential unsafe condition, Pilatus issued Service Bulletin (SB) No. 57-006 (hereafter referred to as `the SB' in this AD) to provide inspection instructions.
For the reason described above, this AD requires identification and inspection of the affected aileron mass-balance counterweight attachment parts and, depending on findings, accomplishment of applicable corrective action(s).
You may examine the MCAI on the Internet at
Pilatus Aircraft Ltd. has issued Pilatus PC-6 Service Bulletin No. 57-006, dated May 13, 2016. The service information describes procedures for removal, installation, and inspection of the ailerons, aileron balance tabs, and the aileron counterweights and their attaching parts. 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
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.
We estimate that this proposed AD will affect 30 products of U.S. registry. We also estimate that it would take about 2 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Required parts would cost about $100 per product.
Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $8,100, or $270 per product.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(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 proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by December 19, 2016.
None.
This AD applies to PILATUS Models PC-6, PC-6-H1, PC-6-H2, PC-6/350, PC-6/350-H1, PC-6/350-H2, PC-6/A, PC-6/A-H1, PC-6/A-H2, PC-6/B-H2, PC-6/B1-H2, PC- 6/B2-H2, PC-6/B2-H4, PC-6/C-H2, and PC-6/C1-H2 airplanes, all manufacturer serial numbers (MSN), including MSN 2001 through 2092 (see Note 1 of paragraph c), certificated in any category.
For MSN 2001-2092, these airplanes are also identified as Fairchild Republic Company PC-6 airplanes, Fairchild Industries PC-6 airplanes, Fairchild Heli Porter PC-6 airplanes, or Fairchild-Hiller Corporation PC-6 airplanes.
Air Transport Association of America (ATA) Code 57: Wings.
This AD was prompted by certain combinations of the aileron counterweight and the attaching parts possibly resulting in reduced thread engagement and leading to disconnection of the aileron counterweight from the aileron. We are issuing this proposed AD to prevent disconnection of the aileron counterweight from the aileron, which could result in loss of control.
Unless already done, do the following actions as specified in paragraphs (f)(1) and (2) of this AD:
(1) Within the next 12 months after the effective date of this AD or the next time the ailerons or aileron counterweights are removed or installed, whichever occurs first, and thereafter anytime the ailerons or aileron counterweights are removed or installed, remove each aileron counterweight to inspect the type and number of washers required for the installation of a counterweight on each aileron following the accomplishment instructions of paragraphs 3.B.(2) and 3.B.(3) of Pilatus PC-6 Service Bulletin (SB) No. 57-006, dated May 13, 2016.
(2) Before further flight after the inspection required by paragraph (f)(1) of this AD, reinstall each aileron counterweight on the airplane following the accomplishment instructions of paragraph 3.B.(3) of Pilatus PC-6 SB No. 57-006, dated May 13, 2016.
The following provisions also apply to this AD:
(1)
(2)
Refer to MCAI EASA AD No.: 2016-0183, dated September 13, 2016, for related information. You may examine the MCAI on the Internet at
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for all Turbomeca S.A. Arriel 2B turboshaft engines. This proposed AD was prompted by a report of an uncommanded in-flight shutdown (IFSD) on a single-engine helicopter, caused by a low returning spring rate of the needle of the hydro-mechanical metering unit (HMU). This proposed AD would require removing any pre-modification (mod) TU 158 HMU and replacing with a part eligible for installation. We are proposing this AD to prevent failure of the HMU, failure of the engine, IFSD, and loss of the helicopter.
We must receive comments on this NPRM by December 19, 2016.
You may send comments by any of the following methods:
•
•
•
•
For service information identified in this proposed AD, contact Turbomeca S.A., 40220 Tarnos, France; phone: (33) 05 59 74 40 00; fax: (33) 05 59 74 45 15. You may view this service information at the FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125. It is also available on the Internet at
You may examine the AD docket on the Internet at
Kenneth Steeves, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7765; fax: 781-238-7199; email:
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA AD 2016-0098, dated May 23, 2016 (referred to hereinafter as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:
Following a report of an un-commanded in-flight shut-down (IFSD), Turbomeca carried out an engineering investigation. This investigation concluded that the cause of the event was a low returning spring rate of the needle of the hydro-mechanical metering unit (HMU), which enabled needle oscillation during rapid engine deceleration.
This condition, if not corrected, could lead to further cases of IFSD, possibly resulting in an emergency landing on single engine.
To address this potential unsafe condition, Turbomeca developed modification (Mod) TU 158, which increases needle return spring rate to prevent oscillation during rapid deceleration, thus preventing the risk of un-commanded IFSD. Turbomeca also published Mandatory Service Bulletin (MSB) 292 73 3158 for embodiment of this modification in service.
You may obtain further information by examining the MCAI in the AD docket on the Internet at
Turbomeca S.A. has issued MSB No. 292 73 3158, Version A, dated April 7, 2016. The MSB describes procedures for removing the pre-mod TU 158 HMU and replacing with an HMU modified with mod TU 158. 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
This product has been approved by the aviation authority of France, and is approved for operation in the United States. Pursuant to our bilateral agreement with the European Community, EASA has notified us of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all information provided by EASA and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design. This AD would require removing the pre-mod TU 158 HMU and replacing with a part eligible for installation.
We estimate that this proposed AD affects 124 engines installed on helicopters of U.S. registry. We also estimate that it will take about 2.0 hours per engine to comply with this AD. The average labor rate is $85 per hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $21,080.
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,
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, 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 proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by December 19, 2016.
None.
This AD applies to all Turbomeca S.A. Arriel 2B turboshaft engines with a pre-modification (mod) TU 158 hydro-mechanical metering unit (HMU), installed.
This AD was prompted by a report of an uncommanded in-flight shutdown (IFSD) on a single engine helicopter caused by a low returning spring rate of the needle of the HMU. We are issuing this AD to prevent failure of the HMU, failure of the engine, IFSD and loss of the helicopter.
Comply with this AD within the compliance times specified, unless already done.
(1) For an engine in pre-mod TU 158 configuration, within 200 engine hours, or within 5 months, whichever occurs first after the effective date of this AD, remove the pre-mod TU 158 HMU from service and replace with a part eligible for installation.
(2) Reserved.
After the effective date of the AD, do not install any pre-mod TU 158 HMU into any engine.
For the purpose of this AD, an HMU eligible for installation is one that incorporates mod TU 158 in accordance with Turbomeca MSB No. 292 73 3158, Version A, dated April 7, 2016, or other FAA approved parts.
The Manager, Engine Certification Office, may approve AMOCs for this AD. Use the procedures found in 14 CFR 39.19 to make your request. You may email your request to:
(1) For more information about this AD, contact Kenneth Steeves, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7765; fax: 781-238-7199; email:
(2) Refer to MCAI European Aviation Safety Agency (EASA), AD 2016-0098, dated May 23, 2016, for more information. You may examine the MCAI in the AD docket on the Internet at
(3) Turbomeca Mandatory Service Bulletin MSB No. 292 73 3158, Version A, dated April 7, 2016, can be obtained from Turbomeca S.A., using the contact information in paragraph (i)(4) of this proposed AD.
(4) For service information identified in this proposed AD, contact Turbomeca S.A., 40220 Tarnos, France; phone: (33) 05 59 74 40 00; fax: (33) 05 59 74 45 15.
(5) You may view this service information at the FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.
Federal Aviation Administration (FAA), DOT.
Notice of Proposed Rulemaking (NPRM).
This action proposes to establish Class E airspace extending upward from 700 feet above the surface at Hot Springs County Airport, Thermopolis, WY, to support the development of Instrument Flight Rules (IFR) operations under standard instrument approach and departure procedures at the airport, for the safety and management of aircraft within the National Airspace System.
Comments must be received on or before December 19, 2016.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC 20590; telephone: 1-800-647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2016-8163; Airspace Docket No. 16-ANM-2, at the beginning of your comments. You may also submit comments through the Internet at
FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Tom Clark, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4511.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish Class E airspace at Hot Springs County Airport, Thermopolis, WY.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Persons wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2016-8163/Airspace Docket No. 16-ANM-2”. The postcard will be date/time stamped and returned to the commenter.
All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded through the Internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the
This document proposes to amend FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the
The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by establishing Class E airspace extending upward from 700 feet above the surface at Hot Springs County Airport, Thermopolis, WY. Class E airspace would be established within a 4.8-mile radius of Hot Springs County Airport, with segments extending from the 3.5-mile radius to 5.5 miles northwest of the airport, and 7 miles southwest of the airport. This airspace is necessary to support the development of IFR operations in standard instrument approach and departure procedures at the airport.
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11A, dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 4.8-mile radius of Hot Spring County Airport, and within 4.8 miles each side of the airport 230° bearing extending from the 4.8 mile radius to 7 miles southwest of the airport, and within 1.8 miles each side of the airport 055° bearing extending from the 4.8-mile radius to 5.5 miles northeast of the airport.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend Class E airspace at Monongahela, PA, as the Allegheny VHF Omni-directional Range, (VOR), has been decommissioned, requiring airspace reconfiguration at Rostraver Airport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at the airport.
Comments must be received on or before December 19, 2016.
Send comments on this proposal to: U. S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE., West Bldg Ground Floor Rm W12-140, Washington, DC 20590; Telephone: 1-800-647-5527, or (202) 366-9826. You must identify the Docket No. FAA-2016-9102; Airspace Docket No. 16-AEA-6, at the beginning of your comments. You may also submit and review received comments through the Internet at
FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend Class E airspace at Rostraver Airport, Monongahela, PA.
Interested persons are invited to comment on this proposed rule by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in triplicate to the address listed above. You may also submit comments through the Internet at
Persons wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2016-9102; Airspace Docket No. 16-AEA-6.” The postcard will be date/time stamped and returned to the commenter.
All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded through the internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the
This document proposes to amend FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the
The FAA is considering an amendment to Title 14, Code of Federal Regulations (14 CFR) Part 71 to amend Class E airspace extending upward from 700 feet or more above the surface within a 6.5-mile radius of Rostraver Airport, Monongahela, PA, due to the decommissioning of the Allegheny VOR, and to ensure the safety and management of the modified IFR operations at the airport.
Class E airspace designations are published in Paragraph 6005 of FAA Order 7400.11A, dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal would be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (Air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Rostraver Airport.
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to modify the operating schedule that governs the State Route 22 Bridge (Madisonville (SR22) swing span bridge) across the Tchefuncta River, mile 2.5, at Madisonville, St. Tammany Parish, Louisiana. The Louisiana Department of Transportation and Development requested changes to the present drawbridge operating regulations governing the SR 22 swing span bridge, to enhance the flow of vehicle traffic across the bridge.
Comments and related material must reach the Coast Guard on or before January 18, 2017.
You may submit comments identified by docket number USCG-2016-0963 using the Federal eRulemaking Portal at
If you have questions on this proposed rule, call or email David Frank, Bridge Administrator, at 504-671-2128, email
Local governmental officials from St. Tammany Parish and the City of Madisonville, in conjunction with the Louisiana Department of Transportation and Development (LDOTD), requested that the operating regulation of the SR 22 Bridge, a swing span bridge, be changed in order to better accommodate the increased vehicular traffic crossing the bridge especially during the peak, weekday rush hours. Currently, this bridge is governed under 33 CFR 117.500. The current regulation was created to allow for improved vehicular traffic flow during peak rush hours due to the increased population of the western portions of St. Tammany Parish.
Based on a recent study of the current vehicle traffic crossing the bridge, public officials and LDOTD requested that the operating regulation be changed to better meet current bridge use.
The traffic study conducted by the LDOTD determined that the existing vehicular traffic at the intersection of SR 22 and SR 21/SR 1077 is over capacity at peak hours and causes unacceptable levels of delay to roadway traffic. This situation is compounded by the opening of the bridge during these peak hours. A combination of modifications to the
Concurrent with the publication of the Notice of Proposed Rulemaking (NPRM), a Test Deviation [USCG-2016-0963] has been issued to allow the LDOTD to test the proposed schedule and to obtain data and public comments. The test period will be in effect during the entire NPRM comment period. The Coast Guard will review the logs of the drawbridge, the traffic counts provided by LDOTD, and evaluate public comments from this NPRM and the above referenced Temporary Deviation to determine if the requested change to the permanent special drawbridge operating regulation is warranted.
The rule proposes to amend 33 CFR 117.500. The proposed rule change would extend the time between openings from 30 minutes to an hour, between 6 a.m. and 7 p.m., and not require the bridge to open for the passage of vessels at 8 a.m., 5 p.m. and 6 p.m. during the weekday rush hours. This additional time would allow commuters and school buses to cross the bridge freely and prevent vehicular traffic from backing up for over a mile on SR 22. The bridge will open at any time in the case of an emergency.
Approximately 7,500 vehicles cross the bridge daily between the hours of 6 a.m. and 7 p.m. Vessel openings for the month of July indicate that the bridge opened to pass vessels 118 times during the week and 202 times during the weekend. Vessel openings for the month of August dropped to 68 openings during the week and 85 openings during the weekend.
Traffic studies have indicated a significant increase in highway traffic delays caused by bridge openings, consisting of mainly recreational traffic that presently passes through the bridge on scheduled openings, and can adjust their schedules to work with the needs of land transportation. There are no alternate routes available for vessels that wish to transit the bridge site; however, if vessels have a vertical clearance requirement of less than 6.2 feet above MHW, they may transit the bridge site at any time.
We developed this proposed rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on these statutes and Executive Orders and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget.
This regulatory action determination is based on a reduction of commercial vessel traffic on this waterway, and the recreational powerboats and sailboats that routinely transit this waterway can still transit the bridge under the proposed schedule. And, those vessels with a vertical clearance requirement of less than 6.2 feet above MHW, they may transit the bridge site at any time. This regulatory action takes into account the reasonable needs of vessel and vehicular traffic.
The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. While some owners or operators of vessels intending to transit the bridge may be small entities, for the reasons stated in section IV.A above, this proposed rule would not have a significant economic impact on any vessel owner or operator.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of
We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This proposed rule simply promulgates the operating regulations or procedures for drawbridges. Normally such actions are categorically excluded from further review, under figure 2-1, paragraph (32)(e), of the Instruction.
Under figure 2-1, paragraph (32)(e), of the Instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Documents mentioned in this notice, and all public comments, are in our online docket at
Bridges.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 117 as follows:
33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 0170.1.
The draw of the SR 22 Bridge, mile 2.5, at Madisonville, shall open on signal from 7 p.m. to 6 a.m. From 6 a.m. to 7 p.m., the draw need only open on the hour, except that the draw need not open for the passage of vessels at 8 a.m., 5 p.m. and 6 p.m. Monday through Friday except federal holidays. The bridge will open at any time an emergency.
Environmental Protection Agency (EPA).
Proposed rule.
On May 2, 2016, the State of Louisiana submitted a request for the Environmental Protection Agency (EPA) to redesignate the five-parish Baton Rouge Nonattainment Area (BRNA or Area) for the 2008 8-hour ozone National Ambient Air Quality Standards (NAAQS or standard) to attainment and to approve a State Implementation Plan (SIP) revision containing a maintenance plan for the area. EPA is proposing to determine that the BRNA is continuing to attain the 2008 ozone NAAQS; to approve into the SIP the State's plan for maintaining attainment of the standard in the Area, including the motor vehicle emission budgets (MVEBs) for nitrogen oxides (NO
Comments must be received on or before December 5, 2016.
Submit your comments, identified by Docket No. EPA-R06-OAR-2016-0293, at
Wendy Jacques, (214) 665-7395,
Throughout this document wherever “we”, “us”, or “our” is used, we mean the EPA.
EPA is proposing to take the following three separate but related actions, one of which involves multiple elements: (1) To determine that the BRNA continues to attain the 2008 ozone NAAQS;
EPA is proposing to approve Louisiana's maintenance plan for the BRNA as meeting the requirements of section 175A [such approval being one of the Clean Air Act (CAA or Act) criteria for redesignation to attainment status]. The maintenance plan is designed to keep the BRNA in attainment of the 2008 ozone NAAQS through 2027. The maintenance plan includes 2022 and 2027 MVEBs for NO
EPA also proposes to determine that the BRNA has met the requirements for redesignation under section 107(d)(3)(E) of the CAA. Accordingly, in this action, EPA is proposing to approve a request to change the legal designation of the BRNA, as found at 40 CFR part 81, from nonattainment to attainment for the 2008 ozone NAAQS.
EPA is also notifying the public of the status of EPA's adequacy process for the 2022 and 2027 NO
In summary, today's notice of proposed rulemaking is in response to Louisiana's May 2, 2016, redesignation request and associated SIP submission that address the specific issues summarized above and the necessary elements described in section 107(d)(3)(E) of the CAA for redesignation of the BRNA to attainment for the 2008 ozone NAAQS.
On March 12, 2008, EPA promulgated a revised 8-hour ozone NAAQS of 0.075 parts per million (ppm).
Upon promulgation of a new or revised NAAQS, the CAA requires EPA to designate as nonattainment any area that is violating the NAAQS, based on the three most recent years of complete, quality assured, and certified ambient air quality data at the conclusion of the designation process. The BRNA was designated nonattainment for the 2008 ozone NAAQS on May 21, 2012 (effective July 20, 2012) using 2008-2010 ambient air quality data.
The CAA provides the requirements for redesignating a nonattainment area to attainment. Specifically, section 107(d)(3)(E) of the CAA allows for redesignation providing that: (1) The Administrator determines that the area has attained the applicable NAAQS; (2) the Administrator has fully approved the applicable implementation plan for the area under section 110(k); (3) the Administrator determines that the improvement in air quality is due to permanent and enforceable reductions in emissions resulting from implementation of the applicable SIP and applicable Federal air pollutant control regulations and other permanent and enforceable reductions; (4) the Administrator has fully approved a maintenance plan for the area as meeting the requirements of section
On April 16, 1992, EPA provided guidance on redesignation in the General Preamble for the Implementation of title I of the CAA Amendments of 1990 (57 FR 13498), and supplemented this guidance on April 28, 1992 (57 FR 18070). EPA has provided further guidance on processing redesignation requests in the following documents:
On May 2, 2016, the State of Louisiana, through the Louisiana Department of Environmental Quality (LDEQ), requested that EPA redesignate the BRNA to attainment for the 2008 ozone NAAQS. EPA's evaluation indicates that the entire BRNA has attained the 2008 ozone NAAQS, and that the BRNA meets the requirements for redesignation as set forth in section 107(d)(3)(E), including the maintenance plan requirements under section 175A of the CAA. As a result, EPA is proposing to take the three related actions summarized in section I of this notice.
Our analysis of the State's request with respect to the five redesignation criteria provided under CAA section 107(d)(3)(E) is discussed in the following paragraphs of this section.
Criteria (1)—
For redesignating a nonattainment area to attainment, the CAA requires EPA to determine that the area has attained the applicable NAAQS (CAA section 107(d)(3)(E)(i)). For ozone, an area may be considered to be attaining the 2008 ozone NAAQS if it meets the 2008 ozone NAAQS, as determined in accordance with 40 CFR 50.15 and Appendix P of part 50, based on three complete, consecutive calendar years of quality-assured air quality monitoring data. To attain the 2008 ozone NAAQS, the 3-year average of the fourth-highest daily maximum average ozone concentrations measured at each monitor within an area over each year must not exceed 0.075 ppm. Based on the data handling and reporting convention described in 40 CFR part 50, Appendix P, the 2008 ozone NAAQS are attained if the design value is 0.075 ppm or below. The data must be collected and quality-assured in accordance with 40 CFR part 58 and recorded in the EPA Air Quality System (AQS). The monitors generally should have remained at the same location for the duration of the monitoring period required for demonstrating attainment.
EPA is proposing to determine that the BRNA is continuing to attain the 2008 ozone NAAQS. EPA reviewed ozone monitoring data from monitoring stations in the BRNA for the 2008 8-hour ozone NAAQS for 2011-2015, and the design values for each monitor in the Area are less than 0.075 ppm. These data have been quality-assured, are recorded in AQS, and indicate that the Area is attaining the 2008 ozone NAAQS. The fourth-highest 8-hour ozone values at each monitor for 2011, 2012, 2013, 2014, 2015, and the 3-year averages of these values (
The 3-year design value for 2011-2013 for the BRNA is 0.075 ppm,
Criteria (2)—
For redesignating a nonattainment area to attainment, the CAA requires EPA to determine that the state has met all applicable requirements under section 110 and part D of title I of the CAA (CAA section 107(d)(3)(E)(v)) and that the state has a fully approved SIP under section 110(k) for the area (CAA section 107(d)(3)(E)(ii)). EPA proposes to find that Louisiana has met all applicable SIP requirements for the BRNA under section 110 of the CAA (general SIP requirements) for purposes of redesignation. Additionally, EPA proposes to find that the Louisiana SIP satisfies the criterion that it meets applicable SIP requirements for purposes of redesignation under part D of title I of the CAA in accordance with section 107(d)(3)(E)(v). Further, EPA proposes to determine that the SIP is fully approved with respect to all requirements applicable for purposes of redesignation in accordance with section 107(d)(3)(E)(ii). In making these determinations, EPA ascertained which requirements are applicable to the Area and, if applicable, that they are fully approved under section 110(k). SIPs must be fully approved only with respect to requirements that were applicable prior to submittal of the complete redesignation request.
Section 110(a)(2)(D) requires that SIPs contain certain measures to prevent sources in a state from significantly contributing to air quality problems in another state. To implement this provision, EPA has required certain states to establish programs to address the interstate transport of air pollutants. The section 110(a)(2)(D) requirements for a state are not linked with a particular nonattainment area's designation and classification in that state. EPA believes that the requirements linked with a particular nonattainment area's designation and classifications are the relevant measures to evaluate in reviewing a redesignation request. The transport SIP submittal requirements, where applicable, continue to apply to a state regardless of the designation of any one particular area in the state. Thus, EPA does not believe that the CAA's interstate transport requirements should be construed to be applicable requirements for purposes of redesignation.
In addition, EPA believes other section 110 elements that are neither connected with nonattainment plan submissions nor linked with an area's attainment status are applicable requirements for purposes of redesignation. The area will still be subject to these requirements after the area is redesignated. The section 110 and part D requirements that are linked with a particular area's designation and classification are the relevant measures to evaluate in reviewing a redesignation request. This approach is consistent with EPA's existing policy on applicability (
Under section 182(a)(2)(A), states with ozone nonattainment areas that were designated prior to the enactment of the 1990 CAA amendments were required to submit, within six months of classification, all rules and corrections to existing VOC reasonably available control technology (RACT) that were required under section 172(b)(3) of the CAA (and related guidance) prior to the 1990 CAA amendments. The BRNA is subject to the section 182(a)(2) RACT “fix up” and has been approved (59 FR 23166, May 5, 1994).
Section 182(a)(2)(B) requires each state with a marginal ozone nonattainment area that implemented, or was required to implement, an inspection and maintenance (I/M)
Regarding the permitting and offset requirements of section 182(a)(2)(C) and section 182(a)(4), Louisiana does have an approved part D NSR program in place (62 FR 52948, October 10, 1997). However, EPA has determined that areas being redesignated need not comply with the requirement that a NSR program be approved prior to redesignation, provided that the area demonstrates maintenance of the NAAQS without part D NSR, because PSD requirements will apply after redesignation. A more detailed rationale for this view is described in a memorandum from Mary Nichols, Assistant Administrator for Air and Radiation, dated October 14, 1994, entitled, “Part D New Source Review Requirements for Areas Requesting Redesignation to Attainment.” Louisiana's PSD program will automatically become applicable in the BRNA upon redesignation to attainment.
Section 182(a)(3) requires states to submit periodic inventories and emissions statements. Section 182(a)(3)(A) requires states to submit a periodic inventory every three years. As discussed below in the section of this notice titled Criteria (4)(e),
EPA interprets the conformity SIP requirements
EPA has fully approved the applicable Louisiana SIP for the BRNA under section 110(k) of the CAA for all requirements applicable for purposes of redesignation. EPA may rely on prior SIP approvals in approving a redesignation request (
As indicated above, EPA believes that the section 110 elements that are neither connected with nonattainment plan submissions nor linked to an area's nonattainment status are not applicable requirements for purposes of redesignation. EPA has approved all part D requirements applicable for purposes of this redesignation.
Criteria (3)—
For redesignating a nonattainment area to attainment, the CAA requires EPA to determine that the air quality improvement in the area is due to permanent and enforceable reductions in emissions resulting from implementation of the SIP, applicable Federal air pollution control regulations, and other permanent and enforceable reductions (CAA section 107(d)(3)(E)(iii)). EPA has preliminarily determined that Louisiana has demonstrated that the observed air quality improvement in the BRNA is due to permanent and enforceable reductions in emissions resulting from Federal measures and from state measures adopted into the SIP. EPA does not have any information to suggest that the decrease in ozone concentrations in the BRNA is due to unusually favorable meteorological conditions.
Federal measures enacted in recent years have resulted in permanent emission reductions. Most of these emission reductions are enforceable through regulations. The Federal measures that have been implemented include the following:
Criteria (4)—
For redesignating a nonattainment area to attainment, the CAA requires EPA to determine that the area has a fully approved maintenance plan pursuant to section 175A of the CAA (CAA section 107(d)(3)(E)(iv)). In conjunction with its request to redesignate the BRNA to attainment for the 2008 ozone NAAQS, LDEQ submitted a SIP revision to provide for the maintenance of the 2008 ozone NAAQS for at least 10 years after the effective date of redesignation to attainment. EPA believes that this maintenance plan meets the requirements for approval under section 175A of the CAA.
Section 175A of the CAA sets forth the elements of a maintenance plan for areas seeking redesignation from nonattainment to attainment. Under section 175A, the plan must demonstrate continued attainment of the applicable NAAQS for at least 10 years after the Administrator approves a redesignation to attainment. Eight years after the redesignation, the state must submit a revised maintenance plan demonstrating that attainment will continue to be maintained for the 10 years following the initial 10-year period. To address the possibility of future NAAQS violations, the maintenance plan must contain contingency measures as necessary to assure prompt correction of any future violations of the 2008 ozone NAAQS. The Calcagni Memorandum provides further guidance on the content of a maintenance plan, explaining that a maintenance plan should address five requirements: The attainment emissions inventory, maintenance demonstration, monitoring, verification of continued attainment, and a contingency plan.
EPA is proposing to determine that the BRNA has attained the 2008 ozone NAAQS based on quality-assured monitoring data for the 3-year period from 2011-2013, and is continuing to attain the standard based on 2012-2014 and 2013-2015 data. Louisiana selected 2011 as the base year (
The emissions inventory is composed of four major types of sources: nonroad, onroad, nonpoint and point. The complete descriptions of how the inventories were developed are discussed in the Appendix F and Appendix K of the May 2, 2016, submittal, which can be found in the docket for this action. The 2011 NOx and VOC emissions for the BRNA, as well as the emissions for other years, were developed consistent with EPA guidance and are summarized in Table 2 of the following subsection discussing the maintenance demonstration.
The maintenance plan associated with the redesignation request includes a maintenance demonstration that:
(i) Shows compliance with and maintenance of the 2008 ozone NAAQS by providing information to support the demonstration that current and future emissions of NOx and VOC remain at or below 2011 emissions levels.
(ii) Uses 2011 as the attainment year and includes future emissions inventory projections for 2022 and 2027.
(iii) Identifies an “out year” at least 10 years after the time necessary for EPA to review and approve the maintenance plan. Per 40 CFR part 93, NOx and VOC
(iv) Provides actual (2011) and projected emissions inventories, in tons per day (tpd), for the BRNA, as shown in Table 2, below.
On July 5, 2016, we approved the BRNA 2011 Base Year Emissions Inventory (EI) for the 2008 8 Hour NAAQS.
There currently are 8 monitors measuring ozone in the BRNA. The State of Louisiana, through LDEQ, has committed to continue operation of the monitors in the BRNA throughout the maintenance period in compliance with 40 CFR part 58.
The State of Louisiana, through LDEQ, has the legal authority to enforce and implement the maintenance plan for the BRNA. This includes the authority to adopt, implement, and enforce any subsequent emissions control contingency measures determined to be necessary to correct future ozone attainment problems.
LDEQ will track the progress of the maintenance plan through continued ambient ozone monitoring in accordance with the requirements of 40 CFR part 58, and by performing future reviews of actual emissions from all sources in the area using the latest emissions factors, models, and methodologies. LDEQ will work with EPA to ensure that the air monitoring network continues to be effective and will quality assure the data according to Federal requirements as one way to verify continued attainment.
Additionally, under the Air Emissions Reporting Requirements (AERR), LDEQ is required to develop a comprehensive, annual, statewide emissions inventory every three years that is due twelve to eighteen months after the completion of the inventory year. As noted above, LDEQ will compare emission inventory data submitted to the National Emission Inventory with the emission growth data submitted in the maintenance plan to ensure emission reductions (from all sources, collectively) continue the downward trend.
Section 175A of the CAA requires that a maintenance plan include such contingency measures as EPA deems necessary to assure that the state will promptly correct a violation of the NAAQS that occurs after redesignation. The maintenance plan should identify the contingency measures to be adopted, a schedule and procedure for adoption and implementation, and a time limit for action by the state. A state should also identify specific indicators to be used to determine when the contingency measures need to be implemented.
The contingency plan included in the submittal includes a triggering mechanism to determine when contingency measures are needed and a process of developing and implementing appropriate control measures. The trigger of the contingency plan will be a violation of the 2008 ozone NAAQS (
Once a trigger is activated, the LDEQ has committed to adopt additional measures, if LDEQ determines that the violations are caused by sources within the State, and to implement the measures as expeditiously as practicable, but no later than 24 months following the trigger. The following contingency measures are identified for possible implementation, but may not be limited to:
• Extending the applicability of the state's NO
• Diesel retrofit/replacement initiatives;
• Programs or incentives to decrease motor vehicle use;
• Implementation of fuel programs, including incentives for alternative fuels;
• Employer-based transportation management plans;
• Anti-backsliding ordinances; and
• Programs to limit or restrict vehicle use in areas of high emissions concentration during periods of peak use.
Given the substantial amount of industrial emissions in the BRNA, and the fact the Area's ozone problem is mostly driven by NO
EPA proposes to conclude that the maintenance plan adequately addresses the five basic components of a maintenance plan: the attainment emissions inventory, maintenance demonstration, monitoring, verification of continued attainment, and a
Under section 176(c) of the CAA, new transportation plans, programs, and projects, such as the construction of new highways, must “conform” to (
Under the CAA, states are required to submit, at various times, control strategy SIPs and maintenance plans for nonattainment areas. These control strategy SIPs, including maintenance plans, create MVEBs for criteria pollutants and/or their precursors to address pollution from cars and trucks. Per 40 CFR part 93, a MVEB must be established for the last year of the maintenance plan. A state may adopt MVEBs for other years as well. The MVEB is the portion of the total allowable emissions in the maintenance demonstration that is allocated to highway and transit vehicle use and emissions.
As part of the interagency consultation process on setting MVEBs, LDEQ held discussions to determine what years to set MVEBs for the BRNA maintenance plan. According to the transportation conformity rule, a maintenance plan must establish MVEBs for the last year of the maintenance plan (in this case, 2027).
Through this rulemaking, EPA is proposing to approve the MVEBs for NO
EPA found the BRNA MVEBs adequate for transportation conformity purposes effective July 14, 2016,
EPA's substantive criteria for determining adequacy of a MVEB are set out in 40 CFR 93.118(e)(4). The process for determining adequacy consists of three basic steps: public notification of a SIP submission, a public comment period, and EPA's adequacy determination. This process for determining the adequacy of submitted MVEBs for transportation conformity purposes was initially outlined in EPA's May 14, 1999, guidance, “Conformity Guidance on Implementation of March 2, 1999, Conformity Court Decision.” EPA adopted regulations to codify the adequacy process in the Transportation Conformity Rule Amendments for the “New 8-Hour Ozone and PM
EPA's proposed actions establish the basis upon which EPA may take final action on the issues being proposed for approval today. Approval of Louisiana's redesignation request would change the legal designation of the BRNA as found at 40 CFR part 81, from nonattainment to attainment for the 2008 ozone NAAQS. Approval of Louisiana's associated SIP revision would also incorporate a plan for maintaining the 2008 ozone NAAQS in the BRNA through 2027 into the SIP. This maintenance plan includes contingency measures to remedy any future violations of the 2008 ozone NAAQS and procedures for evaluation of potential violations. The maintenance plan also establishes NOx and VOC MVEBs for 2022 and 2027 for the Baton Rouge Area. The MVEBs are listed in Table 5 in section VI. Additionally, EPA is notifying the public of the status of EPA's adequacy determination for the newly-established NOx and VOC MVEBs for 2022 and 2027 for the Baton Rouge Area.
EPA is proposing three separate but related actions regarding the redesignation and maintenance of the 2008 ozone NAAQS for the BRNA. EPA is proposing to determine that the BRNA is attaining the 2008 ozone NAAQS. EPA is also proposing to approve the maintenance plan for the BRNA, including the NO
Additionally, EPA is proposing to determine that the BRNA has met the criteria under CAA section 107(d)(3)(E) for redesignation from nonattainment to attainment for the 2008 ozone NAAQS. On this basis, EPA is proposing to approve Louisiana's redesignation request for the BRNA. If finalized, approval of the redesignation request would change the official designation of the portion of BRNA, as found at 40 CFR part 81, from nonattainment to attainment for the 2008 ozone NAAQS.
Under the CAA, redesignation of an area to attainment and the accompanying approval of a maintenance plan under section 107(d)(3)(E) are actions that affect the status of a geographical area and do not impose any additional regulatory requirements on sources beyond those imposed by state law. A redesignation to attainment does not in and of itself create any new requirements, but rather results in the applicability of requirements contained in the CAA for areas that have been redesignated to attainment. Moreover, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations.
• Are not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• do not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• are certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• do not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4);
• do not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• are not economically significant regulatory actions based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• are not significant regulatory actions subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• are not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• do not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the proposed rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
Environmental protection, Air pollution control.
42 U.S.C. 7401
Centers for Medicare & Medicaid Services (CMS), HHS.
Proposed rule.
This proposed rule would update fire safety standards for Medicare and Medicaid participating ESRD facilities, adopt the 2012 edition of the Life Safety Code and eliminate references in our regulations to all earlier editions of the Life Safety Code and adopt the 2012 edition of the Health Care Facilities Code, with some exceptions.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on January 3, 2017.
In commenting, please refer to file code CMS-3334-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one of the ways listed):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
4.
a. For delivery in Washington, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201
(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786-9994 in advance to schedule your arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.
For information on viewing public comments, see the beginning of the
Kristin Shifflett, (410) 786-4133.
Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.
The Life Safety Code (LSC) is a compilation of fire safety requirements for new and existing buildings, and is updated and published every 3 years by the National Fire Protection Association (NFPA), a private, nonprofit organization dedicated to reducing loss of life due to fire. The Medicare and Medicaid regulations have historically incorporated these requirements by reference, along with Secretarial waiver authority. The statutory basis for incorporating NFPA's LSC into the regulations we apply to Medicare and, as applicable, Medicaid providers and suppliers is the Secretary of the Department of Health and Human Services' (the Secretary) authority to stipulate health, safety and other regulations for each type of Medicare and (if applicable) Medicaid-participating facility. Specifically, section 1881(b)(1)(A) of the Social Security Act (the Act) provides for payments for “providers of services and renal dialysis facilities which meet such requirements as the Secretary shall by regulation prescribe for institutional dialysis services and supplies . . . . ” Under this statutory authority, the Secretary has set out “Conditions for Coverage,” including LSC compliance requirements, at 42 CFR part 494, subpart B. Our current LSC provisions are set out at § 494.60(e).
In implementing the LSC provisions, we have given ourselves the discretion to waive specific provisions of the LSC for facilities if application of our rules would result in unreasonable hardship for the facility, and if the health and safety of its patients would not be compromised by such waiver. For dialysis facilities, that authority is set out at § 494.60(e)(4). In addition, the Secretary may accept a State's fire and safety code instead of the LSC if the Centers for Medicare & Medicaid Services (CMS) determines that the protections of the State's fire and safety code are equivalent to, or more stringent than, the protections offered by the LSC; dialysis facility provisions to that effect are set out at § 494.60(e)(3). These flexibilities mitigate the potential unnecessary burdens of applying the requirements of the LSC to all affected health care facilities.
On May 12, 2012, we published a final rule in the
The phrase “exit to the outside at grade level from the patient treatment area level” applies to dialysis facilities that are on the ground or grade level of a building where patients do not have to traverse up or down stairways within the building to evacuate to the outside. Accessibility ramps in the exit area that provide an ease of access between the patient treatment level and the outside ground level are not considered stairways.
A dialysis facility which provides one or more exits to the outside at grade level from patient treatment level and which has a patient exit path to the outside (which may include an
In this rule, we are proposing to update our requirements for dialysis facilities that do not provide one or more exits to the outside at grade level from the patient treatment area level, by incorporating by reference the 2012 edition of NFPA 101 and NFPA 99. These facilities are already required to meet the 2000 edition of the LSC; other provider types affected by the LSC are now required to meet the 2012 edition of the NFPA 101 and the NFPA 99 (LSC final rule published May 4, 2016 at 81 FR 26872). The 2012 edition of the LSC includes new provisions that we believe are vital to the health and safety of all patients and staff. Our intention is to ensure that patients and staff continue to experience the highest degree of fire safety possible.
The NFPA 101 2012 edition of the LSC provides minimum requirements, with due regard to function, for the design, operation and maintenance of buildings and structures for safety to life from fire. Its provisions also aid life safety in similar emergencies.
The NFPA 99 2012 edition of the Health Care Facilities Code provides minimum requirements for health care facilities for the installation, inspection, testing, maintenance, performance, and safe practices for facilities, material, equipment, and appliances.
The 2012 edition of the LSC includes new provisions that we believe are vital to the health and safety of all patients and staff. Our intention is to ensure that patients and staff continue to experience the highest degree of fire safety possible. We do review each edition of the NFPA 101 and NFPA 99 every 3 years to see if there are any significant provisions that we need to adopt. CMS will continue to review revisions to ensure we meet proper standards for patient safety. We have reviewed the 2015 edition of the NFPA 101 and NFPA 99 and do not believe that there are any significant provisions that need to be addressed at this time. Newer buildings are typically built to comply with the newer versions of the LSC because state and local jurisdictions often adopt and enforce newer versions of the LSC as they become available.
CMS must emphasize that the LSC is not an accessibility code, and compliance with the LSC does not ensure compliance with the requirements of the ADA. State and local government programs and services, including health care facilities, are required to comply with Title II of the ADA. Private entities that operate public accommodations such as nursing homes, hospitals, and social service center establishments are required to comply with Title III of the ADA. Entities that receive federal financial assistance from the Department of Health and Human Services, including Medicare and Medicaid, are also required to comply with section 504 of the Rehabilitation Act of 1973. The same accessibility standards apply regardless of whether health care facilities are covered under Title II or Title III of the ADA or section 504 of the Rehabilitation Act of 1973.
This proposed rule would incorporate by reference the NFPA 101® 2012 edition of the LSC, issued August 11, 2011, and all Tentative Interim Amendments issued prior to April 16, 2014; and the NFPA 99® 2012 edition of the Health Care Facilities Code, issued August 11, 2011, and Tentative Interim Amendments issued prior to April 16, 2014 in § 494.60(g).
These materials have been previously incorporated by reference for other provider types by a final rule titled “Medicare and Medicaid Programs; Fire Safety Requirements for Certain Health Care Facilities” published on May 4, 2016 (81 FR 26872).
The materials that are incorporated by reference can be found for interested parties and are available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD 21244, or from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If any changes to this edition of the Code are incorporated by reference, CMS will publish a document in the
According to our memorandum, “Survey & Certification: 13-47-LSC/ESRD,” issued July 12, 2013, dialysis facilities that are subject to the LSC provisions must meet the requirements of the Ambulatory Health Care Occupancy chapters 20 and 21 of the LSC. Dialysis facilities that are not subject to our LSC regulations must continue to meet State and local fire codes. (See
The following are key provisions in the 2012 edition of the LSC from Chapter 20, “New Ambulatory Health Care Occupancies” and Chapter 21, “Existing Ambulatory Health Care Occupancies.” We have provided the LSC citation and a description of the requirement.
The 2012 edition of the LSC defines an “Ambulatory Health Care Occupancy” as a facility capable of treating 4 or more patients simultaneously on an outpatient basis. We believe that dialysis facilities that do not provide one or more exits to the outside at grade level from the patient treatment area should also be required to meet the provisions applicable to Ambulatory Health Care Occupancy Chapters, regardless of the number of patients served, as a matter of health and safety of patients receiving services in these facilities. In the burden reduction final rule, published in the
This provision requires all doors to hazardous areas be self-closing or close automatically.
This provision explicitly allows aerosol dispensers, in addition to gel hand rub dispensers. The aerosol dispensers are subject to limitations on size, quantity, and location, just as gel dispensers are limited. Automatic dispensers are also now permitted in ambulatory care facilities, provided, among other things, that—(1) they do not release contents unless they are activated; (2) the activation occurs only when an object is within 4 inches of the sensing device; (3) any object placed in the activation zone and left in place must not cause more than one activation; (4) the dispenser must not dispense more than the amount required for hand hygiene consistent with the label instructions; (5) the dispenser is designed, constructed and operated in a way to minimize accidental or malicious dispensing; and (6) all dispensers are tested in accordance with the manufacturer's care and use instructions each time a new refill is installed. The provision further defines prior language regarding “above or adjacent to an ignition source” as being “within 1 inch” of the ignition source.
This provision is related to sprinkler system requirements and requires the evacuation of a building or the instituting of an approved fire watch when a sprinkler system is out of service for more than 10 hours in a 24-hour period until the system has been returned to service. A facility must evacuate the building or portion of the building affected by the system outage until the system is back in service, or establish a fire watch until the system is back in service.
The 2012 edition of the NFPA 99, “Health Care Facilities Code,” addresses requirements for both health care occupancies and ambulatory care occupancies, and serves as a resource for those who are responsible for protecting health care facilities from fire and associated hazards. The purpose of this Code is to provide minimum requirements for the installation, inspection, testing, maintenance, performance, and safe practices for health care facility materials, equipment and appliances. This Code is a compilation of documents that have been developed over a 40-year period by NFPA, and is intended to be used by those persons involved in the design, construction, inspection, and operation of health care facilities, and in the design, manufacture, and testing of appliances and equipment used in patient care areas of health care facilities. It provides information on subjects, for example, medical gas and vacuum systems, electrical systems, electrical equipment, and gas equipment. The NFPA 99 applies specific requirements in accordance with the results of a risk-based assessment methodology. A risk-based approach allows for the application of requirements based upon the types of treatment and services being provided to patients or residents rather than the type of facility in which they are being performed. In order to ensure the minimum level of protection afforded by NFPA 99 is applicable to all patient and resident care areas within a health care facility, we are proposing adoption of the 2012 edition of NFPA 99, with the exception of chapters 7—“Information Technology and Communications Systems for Health Care Facilities”; 8—“Plumbing”; 12—“Emergency Management”; and 13—“Security Management”. The first three chapters of the NFPA 99 address the administration of the NFPA 99, the referenced publications, and definitions. Short descriptions of some of the more important provisions of NFPA 99 follow:
Chapter 4 provides guidance on how to apply NFPA 99 requirements to health care facilities based upon “categories” determined when using a risk-based methodology.
There are four categories utilized in the risk assessment methodology, depending on the types of treatment and services being provided to patients or residents. Section 4.1.1 of NFPA 99 describes Category 1 as, “Facility systems in which failure of such equipment or system is likely to cause major injury or death of patients or caregivers. . . .” Section A.4.1.1 provides examples of what a major injury could include, such as amputation or a burn to the eye. Section 4.1.2 describes Category 2 as, “Facility systems in which failure of such equipment is likely to cause minor injury to patients or caregivers. . . .” Section A.4.1.2 describes a minor injury as one that is not serious or involving risk of life. Section 4.1.3 describes Category 3 as, “Facility systems in which failure of such equipment is not likely to cause injury to patients or caregivers, but can cause patient discomfort. . . .” Section 4.1.4 describes Category 4 as, “Facility systems in which failure of such equipment would have no impact on patient care. . . .”
Section 4.2 requires that each facility that is a health care or ambulatory occupancy define its risk assessment methodology, implement the methodology, and document the results. We did not propose to require the use of any particular risk assessment procedure. However, if future situations indicate the need to define a particular risk assessment procedure, we would pursue that through a separate notice and comment rulemaking.
The hazards addressed in Chapter 5 include the ability of oxygen and nitrous oxide to exacerbate fires, safety concerns from the storage and use of pressurized gas, and the reliance upon medical gas and vacuum systems for patient care. Chapter 5 does not mandate the installation of any systems; rather, if they are installed or are required to be installed, the systems will be required to comply with NFPA 99. Chapter 5 covers the performance, maintenance, installation, and testing of the following:
• Nonflammable medical gas systems with operating pressure below a gauge pressure of 300 psi;
• Vacuum systems in health care facilities;
• Waste anesthetic gas disposal systems (WAGD); and
• Manufactured assemblies that are intended for connection to the medical gas, vacuum, or WAGD systems.
The hazards addressed in Chapter 6 are related to the electrical power distribution systems in health care facilities, and address issues such as electrical shock, power continuity, fire, electrocution, and explosions that might be caused by faults in the electrical system. Chapter 6 also covers the performance, maintenance, and testing of the electrical systems in health care facilities.
Chapter 9 requires HVAC systems serving spaces or providing health care functions to be in accordance with the American Society of Heating, Refrigeration and Air-Conditioning Engineers (ASHRAE) Standard 170—Ventilation of Health Care Facilities (2008 edition) (
Chapter 9 does not apply to existing HVAC systems, but applies to the construction of new health care facilities, and the altered, renovated, or modernized portions of existing systems or individual components. Chapter 9 ensures minimum levels of heating, ventilation and air conditioning performance in patient and resident care areas. Some of the issues discussed in Chapter 9 are as follows:
• HVAC system energy conservation;
• Commissioning;
• Piping;
• Ductwork;
• Acoustics;
• Requirements for the ventilation of medical gas storage and trans-filling areas;
• Waste anesthetic gases;
• Plumes from medical procedures;
• Emergency power system rooms; and
• Ventilation during construction.
Chapter 10 covers the performance, maintenance, and testing of electrical equipment in health care facilities. Much of this chapter applies to requirements for portable electrical equipment in health care facilities, but there are also requirements for fixed-equipment and information on administrative issues.
The hazards addressed in Chapter 11 relate to general fire, explosions, and mechanical issues associated with gas equipment, including compressed gas cylinders.
Chapter 14 addresses the hazards associated with hyperbaric facilities in health care facilities, including electrical, explosive, implosive, as well as fire hazards. Chapter 14 sets forth minimum safeguards for the protection of patients and personnel administering hyperbaric therapy and procedures. Chapter 14 contains requirements for hyperbaric chamber manufacturers, hyperbaric facility designers, and personnel operating hyperbaric facilities. It also contains requirements related to construction of the hyperbaric chamber itself and the equipment used for supporting the hyperbaric chamber, as well as administration and maintenance. Many requirements in this chapter are applicable only to new construction and new facilities.
Chapter 15 covers the performance, maintenance, and testing of fire protection equipment in health care facilities. Issues addressed in this chapter range from the use of flammable liquids in an operating room to special sprinkler protection. These fire protection requirements are independent of the risk-based approach, as they are applicable to all patient care areas in both new and existing facilities.
Chapter 15 has several sections taken directly from the NFPA 101, including requirements for the following:
• Construction and compartmentalization of health care facilities.
• Laboratories.
• Utilities.
• Heating, ventilation and air conditioning systems.
• Elevators.
• Escalators.
• Conveyors.
• Rubbish Chutes.
• Incinerators.
• Laundry Chutes.
• Fire detection, alarm and communication systems.
• Automatic sprinklers and other extinguishing equipment.
• Compact storage including mobile storage and maintenance.
• Testing of water based fire protection systems.
These sections have requirements for inspection, testing and maintenance which apply to all facilities, as well as specific requirements for existing systems and equipment that also apply to all facilities.
The prospective timeline for applicability of these requirements would be 60 days after the publication of the final rule in the
This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Because of the large number of public comments we normally receive on
We have examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2).
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This rule does not reach the economic threshold and thus is not considered a major rule.
The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $7.5 million to $38.5 million in any 1 year. Individuals and States are not included in the definition of a small entity. We are not preparing an analysis for the RFA because we have determined, and the Secretary certifies, that this proposed rule would not have a significant economic impact on a substantial number of small entities.
In addition, section 1102(b) of the Social Security Act (the Act) requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. We are not preparing an analysis
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2016, that threshold is approximately $146 million. This rule will have no consequential effect on State, local, or tribal governments or on the private sector.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. Since this regulation does not impose any costs on State or local governments, the requirements of Executive Order 13132 are not applicable.
We do not know how many, if any, dialysis facilities would be affected by this adoption of the 2012 editions of the NFPA 101 and NFPA 99. However, we anticipate that the impact of this rule would be less than $1,000 for each facility, and that is if they are not already meeting the requirements of the 2012 editions of the NFPA 101 and NFPA 99. Twenty states have already adopted the 2012 editions, so if there are facilities in those States, they are already following the 2012 requirements. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.
Health facilities, Incorporation by reference, Kidney diseases, Medicare, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR chapter IV as set forth below:
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395(hh)).
(e) * * *
(1) Except as provided in paragraph (e)(2) of this section, dialysis facilities that do not provide one or more exits to the outside at grade level from the patient treatment area level must comply with provisions of the 2012 edition of the Life Safety Code of the National Fire Protection Association (NFPA 101 and Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4 applicable to Ambulatory Health Care Occupancies (which is incorporated by reference in paragraph (g) of this section), regardless of the number of patients served.
(4) In consideration of a recommendation by the State survey agency or at the discretion of the Secretary, the Secretary may waive, for periods deemed appropriate, specific provisions of the Life Safety Code, which would result in unreasonable hardship upon an ESRD facility, but only if the waiver will not adversely affect the health and safety of the patients.
(5) No dialysis facility may operate in a building that is adjacent to an industrial high hazard area, as described in sections 20.1.3.7 and 21.1.3.7 of the 2012 edition of the Health Care Facilities Code of the National Fire Protection Association (NFPA 99), incorporated by reference in paragraph (g) of this section.
(f)
(2) A copy of the Code is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD.
(3) Chapters 7, 8, 12, and 13 of the NFPA 99 2012 Health Care Facilities Code do not apply to a dialysis facility.
(4) If application of the NFPA 99 would result in unreasonable hardship for the dialysis facility, CMS may waive specific provisions of the Health Care Facilities Code for such facility, but only if the waiver does not adversely affect the health and safety of patients.
(g)
(1) National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02169,
(i) NFPA 99, Standard for Health Care Facilities Code of the National Fire Protection Association 99, 2012 edition, issued August 11, 2011.
(ii) TIA 12-2 to NFPA 99, issued August 11, 2011.
(iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
(iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
(v) TIA 12-5 to NFPA 99, issued August 1, 2013.
(vi) TIA 12-6 to NFPA 99, issued March 3, 2014.
(vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 2011.
(viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
(ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
(x) TIA 12-3 to NFPA 101, issued October 22, 2013.
(xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
(2) [Reserved]
Bureau of Land Management, Interior.
Notice of proposed supplementary rules.
The California State Director of the Bureau of Land Management (BLM) is proposing to establish new supplementary rules related to dog management and public safety on public lands at Fort Ord National Monument (FONM), California.
Furthermore, these proposed rules would clarify some of the existing restrictions that have been in place on the FONM since 1996. These proposed rules are consistent with the national monument proclamation of 2012 (
Interested parties may submit written comments regarding the proposed supplementary rules until January 3, 2017.
You may submit comments by mail, hand-delivery, or electronic mail. Mail: FONM Manager, BLM, Central Coast Field Office, 940 2nd Avenue, Marina, CA 93933.
Eric Morgan, FONM Manager, Bureau of Land Management, Central Coast Field Office, 940 2nd Avenue, Marina, CA 93933, at (831) 582-2200, or
You may mail or email comments to the Central Coast Field Office, at the addresses listed above (See
Comments, including names, street addresses, and other contact information for respondents, will be available for public review at 940 2nd Avenue, Marina, CA 93933, during regular business hours (7:30 a.m. to 4 p.m., Monday through Friday, excluding Federal holidays). Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
The BLM California State Director is proposing to establish new supplementary rules related to dog management and other public safety issues for public lands on the FONM in Monterey County, California. Furthermore, the State Director is supplementing some of the existing land restrictions that have been in place on the monument since December 5, 1996 (61 FR 64530), that are consistent with the national monument proclamation of 2012 (
These proposed rules would implement restrictions prescribed within the FONM Dog Management Plan that was approved on July 5, 2016. The plan was analyzed under environmental assessment DOI-BLM-CA-C090-2016-0021-EA (Fort Ord National Monument Dog Management Plan), and associated Decision Record and Finding of No Significant Impact. The plan considered various dog management prescriptions across the monument within four different planning units. One of the planning units, the Inland Range Planning Unit, contains extremely hazardous military munitions and public use opportunities are greatly limited.
When the former Fort Ord military installation closed in 1994, the Secretary of the Army transferred administration of approximately 7,205 acres to the BLM via a letter of transfer to the Secretary of Interior on October 18, 1996. Those lands are now part of the 14,651 acre FONM that was designated by President Obama under Proclamation 8803. The Army currently manages approximately 7,446 acres of the FONM and will transfer those lands to the BLM for administration following a munitions cleanup being performed under the Comprehensive Environmental Response, Compensation, and Liability Act.
The BLM issued a notice of emergency closure and established restrictions on use of public lands on the former Fort Ord on December 5, 1996 (61 FR 64530). Since that time, the BLM has applied those restrictions as they pertain to public use, but those restrictions did not address management of dogs on these public lands. On September 7, 2007, the BLM State Director approved a Record of Decision for the Southern Diablo Mountain Range and Central Coast of California Resource Management Plan (RMP) that directed the BLM's Central Coast Field Office to develop a dog management plan for FONM due to conflicts between visitors, attacks on livestock, and impacts to wildlife. On April 8, 2015, the BLM notified the public of its intent to develop a dog management plan and, using the 1996 emergency closure, initiated an interim dog leash restriction on public lands at FONM due to increasing conflicts between visitors, attacks on livestock, hazards from munitions, and impacts to wildlife. The BLM held three public scoping workshops (July 28 and 29, 2015, and August 5, 2015) to solicit public input on the development of the draft dog management plan. The proposed supplementary rules are the logical conclusion of the dog management planning process.
On May 17, 2016, the BLM released the Draft FONM Dog Management Plan and associated environmental assessment (DOI-BLM-CA-C090-2016-0021-EA) for a 30 day comment period. The proposed supplementary rules were included with the draft plan and were analyzed within the environmental assessment. One comment was made on the proposed supplementary rules that
On July 5, 2016 the BLM approved the Final FONM Dog Management Plan and associated environmental assessment (DOI-BLM-CA-C090-2016-0021-EA). The proposed supplementary rules (when approved) will supplement some of the December 1996 restrictions and April 2015 restrictions under 43 CFR 8364.1 and 43 CFR 8341.2 and enact new rules that are specified in the Final FONM Dog Management Plan. The proposed supplementary rules also would implement existing Monterey County ordinances germane to dog use under 43 CFR 8365.1-6, 43 U.S.C. 1733(a), 16 U.S.C. 670h(c)(5), and 43 U.S.C. 315a that were disclosed and analyzed within the approved plan.
The proposed supplementary rules are broken into three categories. Proposed supplementary rules numbered 1 through 9 are new and would implement new direction from the approved dog management plan. Proposed supplementary rules 10 through 15 are not new, but would implement previous restrictions that were established in 1996 (see 61 FR 64530) and that are consistent with the national monument proclamation of 2012 (
The proposed supplementary rules are not a significant regulatory action and are not subject to review by the Office of Management and Budget under Executive Orders 12866 and 13563. They would not have an effect of $100 million or more on the economy. The proposed supplementary rules would not adversely affect in a material way the economy, productivity, competition, jobs, the environment, public health and safety, or State, local, or tribal governments or communities. The proposed supplementary rules would not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency. The proposed supplementary rules would not alter the budgetary effects of entitlements, grants, user fees or loan programs, or the rights or obligations of their recipients, nor do they raise novel legal or policy issues. They would merely impose rules of conduct and impose other limitations on certain recreational and commercial activities on certain public lands to protect natural resources and human health and safety.
Executive Order 12866 requires each agency to write regulations that are simple and easy to understand. The BLM invites your comments on how to make these proposed supplementary rules easier to understand, including answers to questions such as the following:
(1) Are the requirements in the supplementary rules clearly stated?
(2) Do the supplementary rules contain technical language or jargon that interferes with their clarity?
(3) Does the format of the supplementary rules (grouping and order of sections, use of headings, paragraphing, etc.) aid or reduce clarity?
(4) Would the supplementary rules be easier to understand if they were divided into more (but shorter) sections?
(5) Is the description of the supplementary rules in the
Please send any comments you have on the clarity of the rule to the addresses specified in the
The BLM has prepared an environmental assessment (EA) that analyzed different dog management alternatives on FONM under Section 102(2)(C) of the National Environmental Policy Act of 1969 (NEPA), 42 U.S.C. 4332(2)(C). On July 5, 2016, the BLM approved the Final FONM Dog Management Plan and associated environmental assessment (DOI-BLM-CA-C090-2016-0021-EA). The proposed supplementary rules are also consistent with the Record of Decision for the Southern Diablo Mountain Range and Central Coast of California RMP approved in 2007.
Congress enacted the Regulatory Flexibility Act (RFA) of 1980, as amended, 5 U.S.C. 601-612, to ensure that government regulations do not unnecessarily or disproportionately burden small entities. The RFA requires a regulatory flexibility analysis if a rule would have a significant economic impact, either detrimental or beneficial, on a substantial number of small entities. The proposed supplementary rules would merely impose reasonable restrictions on certain recreational or commercial activities on public lands in order to protect natural resources and the environment, and provide for human health and safety. Therefore, the BLM has determined under the RFA that the proposed supplementary rules would not have a significant economic impact on a substantial number of small entities.
The proposed supplementary rules are not a “major rule” as defined under 5 U.S.C. 804(2). The proposed supplementary rules would merely revise the rules of conduct for public use of limited areas of public lands and would not affect commercial or business activities of any kind.
The proposed supplementary rules would not impose an unfunded mandate of more than $100 million per year; on State, local, or tribal governments in the aggregate; or on the private sector; nor would they have a significant or unique effect on small governments. The proposed supplementary rules would have no effect on governmental or tribal entities and would impose no requirements on any of these entities. The proposed supplementary rules would merely revise the rules of conduct for public use of limited areas of public lands and would not affect tribal, commercial, or business activities of any kind. Therefore, the BLM is not required to prepare a statement containing the information required by the Unfunded Mandates Reform Act at 2 U.S.C. 1531.
The proposed supplementary rules do not represent a government action capable of interfering with constitutionally protected property rights. Therefore, the BLM has determined that the proposed supplementary rules would not cause a taking of private property or require further discussion of takings implications under this Executive order.
The proposed supplementary rules would not have a substantial direct effect on the States, on the relationship between the National Government and
Under Executive Order 12988, the BLM has determined that the proposed supplementary rules would not unduly burden the judicial system, and that they meet the requirements of sections 3(a) and 3(b)(2) of Executive Order 12988.
In accordance with Executive Order 13175, the BLM has found that the proposed supplementary rules do not include policies that would have tribal implications. The proposed supplementary rules would merely revise the rules of conduct for public use of limited areas of public lands.
In accordance with Executive Order 13352, the BLM has determined that these proposed consolidated supplementary rules would not impede facilitating cooperative conservation; would take appropriate account of and consider the interests of persons with ownership or other legally recognized interests in land or other natural resources. The rules would properly accommodate local participation in the Federal decision-making process, and would provide that the programs, projects, and activities are consistent with protecting public health and safety.
In developing these proposed supplementary rules, the BLM did not conduct or use a study, experiment, or survey requiring peer review under the Information Quality Act (Pub. L. 106-554). In accordance with the Information Quality Act, the DOI has issued guidance regarding the quality of information that it relies on for regulatory decisions. This guidance is available on the DOI's Web site at
Under Executive Order 13211, the BLM has determined that the proposed supplementary rules would not comprise a significant energy action, and that they would not have an adverse effect on energy supplies, production, or consumption.
The proposed supplementary rules do not directly provide for any information collection that the Office of Management and Budget must approve under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3521. Moreover, any information collection that may result from Federal criminal investigations or prosecutions conducted under the proposed supplementary rules are exempt from the provisions of 44 U.S.C. 3518(c)(1).
The principal author of these proposed supplementary rules is Eric Morgan, Monument Manager, Central Coast Field Office, 940 2nd Avenue, Marina, CA 93933.
For the reasons stated in the preamble and under the authorities for supplementary rules found under 43 CFR 8365.1-6, 43 U.S.C. 1733(a), 16 U.S.C. 670h(c)(5), and 43 U.S.C. 315a, the BLM California State Director proposes to issue supplementary rules for public lands managed by the BLM within the boundaries of the FONM, to read as follows:
Unless otherwise authorized by the BLM, the following prohibitions apply to all BLM-managed public lands on the Fort Ord National Monument (FONM):
1. You must not bring a dog into the Inland Range Planning Unit. Service animals accompanying a disabled person as accommodated by the Americans with Disabilities Act are excluded from this provision.
2. You must physically restrain, or keep your dog(s) on a leash or cord not to exceed 6 feet in length, at all times while you are on a road or trail that has not been designated as an “off-leash-opportunity-route.”
3. You and/or your dog must not walk or roam off a designated route, including any route designated as an “off-leash-opportunity route.”
4. You must physically restrain, or keep your dog on a leash or cord not to exceed 6 feet in length, on a designated “off-leash-opportunity-route” when you are within 100 feet of another person and/or dog that is not with your party.
5. You must not allow your dog to roam over 50 feet away from you while on a designated “off-leash-opportunity-route.”
6. You must not allow your dog to enter any vernal pool or pond, or roam within 20 feet of any such area, unless you and your dog are on a route designated for public use.
7. You must carry a leash for each dog you have with you.
8. You are prohibited from leaving a dog unattended, even if on tether, within a crate, or within an unoccupied motor vehicle.
9. Visitors must yield the path, on both roads and trails, to other visitors in the following manner: Bicycles must yield to pedestrians and equestrians; and pedestrians must yield to equestrians. For bicycles, the passing speed shall be no greater than 10 mph on roads, and 5 mph on single-track trails.
10. Motorized vehicles and other motorized devices, including electronic bicycles, are prohibited on all roads and trails excluding Creekside Terrace Road and Badger Hills Driveway. Motorized vehicle use on these two roadways is restricted to highway licensed street-legal vehicles.
11. Use and/or occupancy of all lands within the FONM, including leaving personal property unattended, is prohibited between
12. All use (including pet use) is restricted to designated routes and trails. Open routes and trails are indicated on BLM maps and signed with route or trail markers. Any unsigned route which does not appear on the most current BLM map is closed to all uses.
13. Campfires and other open flame fires are prohibited.
14. Possession or discharge of fireworks, including “safe and sane” fireworks, is prohibited.
15. Wood cutting and the collection of downed wood are prohibited.
16. It shall be unlawful for the owner or person having custody of any dog, either willfully or through failure to exercise due care or control, to allow said dog to defecate and to allow the feces thereafter to remain on FONM other than within trash receptacles provided for such purposes. This includes bagged feces—Reference Monterey County ordinance, 8.36.030.
17. All dogs under four months of age shall be kept under physical restraint by the owner, keeper, or harborer when on FONM—Reference Monterey County ordinance, 8.20.020.
18. Dogs on FONM shall wear a license tag with or without a chip implant at all times. The tag shall be attached at all times to a collar, harness, or other suitable device upon the dog for which the license tag was issued—Reference Monterey County ordinance, 8.08.040.
The following persons are exempt from these supplementary rules: Any Federal, State, or local officer or employee in the scope of their duties; members of any organized law enforcement, rescue, or fire-fighting force in performance of an official duty; and any person whose activities are authorized in writing by the BLM.
Any person who violates any of these supplementary rules may be tried before a United States Magistrate and fined in accordance with 18 U.S.C. 3571, imprisoned no more than 12 months under 43 U.S.C. 1733(a) and 43 CFR 8360.0-7, or both.
In accordance with 43 CFR 8365.1-7, State or local officials may also impose penalties for violations of California law.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of availability; request for comments.
The Gulf of Mexico (Gulf) Fishery Management Council (Gulf Council) has submitted Amendment 43 to the Fishery Management Plan for the Reef Fish Resources of the Gulf of Mexico (FMP) for review, approval, and implementation by NMFS. If approved by the Secretary of Commerce (Secretary), Amendment 43 would revise the hogfish fishery management unit (FMU) to be the West Florida stock and define the geographic range of this stock consistent with the South Atlantic Fishery Management Council's (South Atlantic Council) proposed boundary between the Florida Keys/East Florida and West Florida stocks, set the status determination criteria (SDC) and annual catch limits (ACLs) for the West Florida stock, increase the minimum size limit for the West Florida stock, and remove the powerhead exception for harvest of hogfish in the Gulf reef fish stressed area. The purpose of Amendment 43 is to establish management measures for the West Florida hogfish stock in the Gulf using the best scientific information available.
Written comments must be received by January 3, 2017.
You may submit comments on Amendment 43 identified by “NOAA-NMFS-2016-0126” by either of the following methods:
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Electronic copies of Amendment 43, which includes an environmental assessment, a fishery impact statement, a Regulatory Flexibility Act analysis, and a regulatory impact review, may be obtained from
Peter Hood, NMFS Southeast Regional Office, telephone: 727-824-5305, email:
The Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) requires each regional fishery management council to submit any FMP or amendment to NMFS for review and approval, partial approval, or disapproval. The Magnuson-Stevens Act also requires that NMFS, upon receiving an FMP or amendment, publish an announcement in the
The FMP being revised by Amendment 43 was prepared by the Gulf Council and, if approved, would be
Currently, hogfish in the Gulf exclusive economic zone (EEZ) are managed as a single stock with a stock ACL and no allocation between the commercial and recreational sectors. Although hogfish occur throughout the Gulf, they are caught primarily off the Florida west coast. Generally, the fishing season for both sectors is open year-round, January 1 through December 31. However, accountability measures (AMs) for hogfish specify that if commercial and recreational landings exceed the stock ACL in a fishing year, then during the following fishing year if the stock ACL is reached or is projected to be reached, the commercial and recreational sectors will be closed for the remainder of the fishing year. The hogfish ACL and AMs were implemented in 2012 (76 FR 82044, December 29, 2011). The AMs were triggered when the hogfish ACL was exceeded in 2012, and the 2013 season was closed on December 2 because NMFS determined that the 2013 hogfish stock ACL had been harvested (78 FR 72583, December 3, 2013). The stock ACL was exceeded again in 2013. However, there was no closure in 2014, and the stock ACL was not exceeded in the 2014 or 2015 fishing years.
In 2014, the Florida Fish and Wildlife Conservation Commission (FWC) completed the most recent stock assessment for hogfish through the Southeast Data, Assessment, and Review process (SEDAR 37). SEDAR 37 divided the hogfish stock into three stocks based upon genetic analysis as follows: The West Florida stock, Florida Keys/East Florida stock, and the Georgia through North Carolina stock. The West Florida stock is completely within the jurisdiction of the Gulf Council and the Georgia through North Carolina stock is completely within the jurisdiction of the South Atlantic Council. The Florida Keys/East Florida stock crosses the Councils' jurisdictional boundary, with a small portion of the stock extending into the Gulf Council's jurisdiction off the west coast of Florida. Based on SEDAR 37 and the Gulf and South Atlantic Councils' Scientific and Statistical Committee (SSC) recommendations, NMFS determined the West Florida stock is not overfished or undergoing overfishing, the Florida Keys/East Florida stock is overfished and undergoing overfishing, and the status of the Georgia-North Carolina stock status is unknown.
Amendment 43 includes actions to revise the FMU for hogfish to be the West Florida stock and define the geographic range of this stock consistent with the South Atlantic Council's proposed boundary between the Florida Keys/East Florida and West Florida stocks, and set the SDC and ACL for the West Florida stock. In addition, actions in Amendment 43 increase the minimum size limit for the West Florida stock, and remove the powerhead exception for harvest of hogfish in the Gulf reef fish stressed area.
The South Atlantic Council developed and submitted for review by the Secretary of Commerce a rebuilding plan for the Florida Keys/East Florida hogfish stock through Amendment 37 to the FMP for the Snapper-Grouper Fishery of the South Atlantic Region. Because SEDAR 37 indicated only a small portion of the Florida Keys/East Florida stock extends into the Gulf Council's jurisdiction off south Florida, the Gulf Council through Amendment 43 proposes to revise the hogfish FMU to be the West Florida stock and define the geographic range of this stock consistent with the South Atlantic Council's proposed boundary between the Florida Keys/East Florida and West Florida hogfish stocks near Cape Sable, Florida. This boundary would be a line extending west along 25°09′ N. lat. to the outer boundary of the EEZ. The Gulf Council would manage hogfish (the West Florida stock) in the Gulf EEZ except south of 25°09′ N. lat. off the west coast of Florida. The South Atlantic Council would manage hogfish (the Florida Keys/East Florida stock) in the Gulf EEZ south of 25°09′ N. lat. off the west coast of Florida, and in the South Atlantic EEZ to the state border of Florida and Georgia. The boundary line near Cape Sable is south of the line used in SEDAR 37, which defined the West Florida stock as north of the Monroe and Collier County, Florida, boundary line. Therefore, it is possible that some fish from the Florida Keys/East Florida stock will be harvested under the regulations by the Gulf Council. However, the majority of hogfish landings in Monroe County occur in the Florida Keys, and the proposed boundary is far enough north of the Florida Keys that fishing trips originating in the Florida Keys rarely travel north of the boundary, and far enough south of Naples and Marco Island, Florida, that fishing trips originating from these locations rarely travel south of the boundary. In addition, the boundary line proposed by the Gulf and South Atlantic Councils is currently used by the FWC as a regulatory boundary for certain state-managed species. Using a pre-existing management boundary will increase enforceability and help fishermen by simplifying regulations across adjacent management jurisdictions.
In accordance with section 304(f) of the Magnuson-Stevens Act, the Gulf Council requested that the Secretary designate the South Atlantic Council as the responsible Council for management of the Florida Keys/East Florida hogfish stock in Gulf Federal waters south of 25°09′ N. lat. near Cape Sable on the west coast of Florida. If the Gulf Council's request is approved, the Gulf Council would continue to manage hogfish in Federal waters in the Gulf, except in Federal waters south of this boundary. Therefore, the South Atlantic Council, and not the Gulf Council, would establish the management measures for the entire range of the Florida Keys/East Florida hogfish stock, including in Federal waters south of 25°09′ N. lat. near Cape Sable in the Gulf. Commercial and recreational for-hire vessels fishing for hogfish in Gulf Federal waters,
NMFS specifically seeks public comment regarding the revised stock boundaries and the manner in which the Councils would have jurisdiction over these stocks if both Amendment 37 for the South Atlantic and Amendment 43 for the Gulf of Mexico are approved and implemented.
Currently, the only SDC implemented for Gulf hogfish is the overfishing threshold, or maximum fishing mortality rate (MFMT). The overfished threshold, or minimum stock size threshold (MSST), and maximum sustainable yield (MSY) actions were disapproved when the Gulf Council's Sustainable Fisheries Act Generic Amendment was approved by NMFS on November 17, 1999. Amendment 43 would maintain the current MFMT
The current ACL and annual catch target (ACT) for Gulf hogfish were established based on 1999 through 2008 landings. The ACL and ACT were set using the Gulf Council's acceptable biological catch (ABC) control rule for stocks that have not been assessed but are stable over time. Amendment 43 would set the ACL for the West Florida hogfish stock at 219,000 lb (99,337 kg), round weight, for the 2017 and 2018 fishing years based on recommendations from the Gulf Council's SSC after its review of SEDAR 37. In 2019, and subsequent fishing years, the ACL would be set at the equilibrium ABC of 159,300 lb (72,257 kg), round weight. The Gulf Council decided to discontinue the designation of an ACT, because it is not used in the current AMs or for other management purposes.
Although the West Florida hogfish stock is not overfished or undergoing overfishing, the stock could be subject to seasonal closures should landings exceed the stock ACL and AMs are triggered. In 2012 and 2013, the stock ACL was exceeded, thus causing landings to be closely monitored in 2013 and 2014. This resulted in an in-season closure in 2013 but not in 2014. To reduce the likelihood of AMs being triggered, the Gulf Council determined that increasing the minimum size limit in Federal waters from 12 inches (30.5 cm), fork length (FL), to 14 inches (35.6 cm), FL, could reduce the directed harvest rate and, consequently, reduce the probability of exceeding the stock ACL and triggering AMs. This action has an additional benefit of allowing the hogfish to grow larger and have an additional spawning opportunity before being susceptible to harvest.
Currently, as described at 50 CFR 622.35(a), a regulatory exemption allows for the harvest of hogfish using powerheads in the reef fish stressed area. Amendment 43 would remove this exemption. The powerhead exemption provision is a regulatory holdover from when hogfish were listed as a species in the fishery but not in the reef fish FMU. Harvesting species in the FMU with powerheads in the stressed area was prohibited. By removing the powerhead exemption for hogfish, hogfish would be subject to the same regulations for Gulf reef fish in the stressed area as other species in the reef fish FMU. The coordinates for the reef fish stressed area are provided in 50 CFR part 622, Table 2 in Appendix B.
A proposed rule that would implement Amendment 43 has been drafted. In accordance with the Magnuson-Stevens Act, NMFS is evaluating Amendment 43 to determine whether it is consistent with the FMP, the Magnuson-Stevens Act, and other applicable law. If the determination is affirmative, NMFS will publish the proposed rule in the
The Gulf Council has submitted Amendment 43 for Secretarial review, approval, and implementation. Comments on Amendment 43 must be received by January 3, 2017. Comments received during the respective comment periods, whether specifically directed to Amendment 43 or the proposed rule, will be considered by NMFS in its decision to approve, partially approve, or disapprove Amendment 43. Comments received after the comment periods will not be considered by NMFS in this decision. All comments received by NMFS on Amendment 43 or the proposed rule during their respective comment periods will be addressed in the final rule.
16 U.S.C. 1801
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 with a revision of a currently approved information collection that supports Inventory Property Management. The collected information is used to evaluate applicant requests to purchase inventory property, determine eligibility to lease or purchase inventory property, and ensure the payment of the lease amount or purchase amount associated with the acquisition of inventory property. Revisions to the information collection includes an increase in the total amount of burden hours expected related to inventory property requests.
We will consider comments that we receive by January 3, 2017.
We invite you to submit comments on this notice. In your comments, include date, volume, and page number, the OMB control number, and the title of the information collection 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. Copies of the information collection may be requested by contacting J. Lee Nault at the above address.
J. Lee Nault, (202) 720-6834.
Abstract: FSA's Farm Loan Programs provide supervised credit in the form of loans to family farmers to purchase real estate and equipment and finance agricultural production. Inventory Property Management, as specified in 7 CFR part 767, provides the requirements for the management, lease, and sale of security property acquired by FSA. FSA may take title to real estate as part of dealing with a problem loan either by entering a winning bid in an attempt to protect its interest at a foreclosure sale, or by accepting a deed of conveyance in lieu of foreclosure. Information collections established in the regulation are necessary for FSA to determine an applicant's eligibility to lease or purchase inventory property and to ensure the applicant's ability to make payment on the lease or purchase amount.
The number of respondents and burden hours increase in the request. The increase is based on an approximate 13% increase in the number of inventory properties being held by FSA since the previous approval request. No additional forms, response actions, or time increases are added to the request.
The formula used to calculate the total burden hour is estimated average time per responses hours times total annual responses.
We are requesting comments on all aspects of this information collection 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, utility, 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 where provided, will be made a matter of public record. Comments will be summarized and included in the request for OMB approval of the information collection.
Forest Service, USDA.
Notice of meeting.
The Fremont and Winema Resource Advisory Committee (RAC) will meet in Klamath Falls, Oregon. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. RAC information can be found at the following Web site:
The meeting will be held on November 17, 2016, from 9 a.m. to 5 p.m.
All RAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under
The meeting will be held at the Klamath Ranger Station, 2819 Dahlia Street, Klamath Falls, Oregon.
Written comments may be submitted as described under
David Brillenz, Designated Federal Official by phone at 541-947-6328, or by email at
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.
The purpose of the meeting is to provide:
(1) Recommendations to the Forest Service concerning projects in Klamath County, and
(2) Funding consistent with Title II of the Act.
The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request it in writing by November 7, 2016, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time to make oral comments must be sent to Roland Giller, Partnership Coordinator, 38500 Highway 97 North, Chiloquin, Oregon 97624; or by email to
All reasonable accommodation requests are managed on a case by case basis.
Forest Service, USDA.
Notice of meeting.
The Fremont and Winema Resource Advisory Committee (RAC) will meet in Lakeview, Oregon. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. RAC information can be found at the following Web site:
The meeting will be held on November 16, 2016, from 9 a.m. to 5 p.m.
All RAC meetings are subject to cancellation. For status of the meeting prior to attendance, please contact the person listed under
The meeting will be held at the Lakeview Interagency Building, Main Conference Rooms, 1301 South G Street, Lakeview, Oregon.
Written comments may be submitted as described under
David Brillenz, Designated Federal Official by phone at 541-947-6328, or by email at
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.
The purpose of the meeting is to provide:
(1) Recommendations to the Forest Service concerning projects in Lake County; and
(2) Funding consistent with Title II of the Act.
The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request it in writing by November 7, 2016, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time to make oral comments must be sent to Roland Giller, Partnership Coordinator, 38500 Highway 97 North, Chiloquin, Oregon 97624; or by email to
Forest Service, USDA.
Notice of meeting.
The Black Hills National Forest Advisory Board (Board) will meet in Rapid City, South Dakota. The Board is established consistent with the Federal Advisory Committee Act of 1972 (5 U.S.C. App. II), the Forest and Rangeland Renewable Resources Planning Act of 1974 (16 U.S.C. 1600
The meeting will be held on Wednesday, November 16, 2016, at 1:00 p.m.
All meetings are subject to cancellation. For updated status of meeting prior to attendance, please contact the person listed under
The meeting will be held at the Mystic Ranger District, 8221 South Highway 16, Rapid City, South Dakota.
Written comments may be submitted as described under
Scott Jacobson, Board Coordinator by phone at 605-440-1409, or by email at
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.
The purpose of the meeting is to provide:
(1) Orientation Topic—Forest Plan Overview;
(2) Structural Stages of the Forest;
(3) Black Hills Resilient Landscapes (BHRL) Project update;
(4) MPB—Epidemic to Endemic; and
(5) 2016 Aerial Photo Results/Update.
The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should submit a request in writing by November 7, 2016, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the Board may file written statements with the Board's staff before or after the meeting. Written comments and time requests for oral comments must be sent to Scott Jacobson, Black Hills National Forest Supervisor's Office, 1019 North Fifth Street, Custer, South Dakota 57730; by email to
Commission on Civil Rights.
Notice; correction.
The Commission on Civil Rights published a notice in the
Evelyn Bohor, (202) 376-7533.
In the
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 planning meetings of the Maine Advisory Committee to the Commission will convene by conference call at 1:30 p.m. (ET) on: Tuesday, October 18, 2016; Tuesday, November 15, 2016; Tuesday, December 20, 2016; Tuesday, January, 17, 2017 and Tuesday, February 21, 2017. The purpose of each meeting is to discuss project planning as the Committee moves to selecting a topic as its civil rights project. The Committee will also select additional officers, as necessary. The November 15 meeting will be to discuss and vote on the Committee's report to the Commission on human trafficking in Maine.
Economic Development Administration, Department of Commerce.
Notice and Opportunity for Public Comment.
Pursuant to Section 251 of the Trade Act 1974, as amended (19 U.S.C. 2341
Any party having a substantial interest in these proceedings may request a public hearing on the matter. A written request for a hearing must be submitted to the Trade Adjustment Assistance for Firms Division, Room 71030, Economic Development Administration, U.S. Department of Commerce, Washington, DC 20230, no later than ten (10) calendar days following publication of this notice.
Please follow the requirements set forth in EDA's regulations at 13 CFR 315.9 for procedures to request a public hearing. The Catalog of Federal Domestic Assistance official number and title for the program under which these petitions are submitted is 11.313, Trade Adjustment Assistance for Firms.
Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C. 81a-81u), the Foreign-Trade Zones Board (the Board) adopts the following Order:
CGT U.S., Ltd. (CGT), submitted a notification of proposed production activity to the FTZ Board for its facility in New Braunfels, Texas. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on October 18, 2016.
A separate application for subzone designation at the CGT facility was submitted and will be processed under Section 400.38 of the Board's regulations. The facility is used for the production of PVC coated upholstery fabric cover stock. Pursuant to 15 CFR 400.14(b), FTZ activity would be limited to the specific foreign-status materials and components and specific finished product described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.
Production under FTZ procedures could exempt CGT from customs duty payments on the foreign-status components used in export production. On its domestic sales, CGT would be able to choose the duty rate during customs entry procedures that applies to the PVC coated upholstery fabric cover stock (duty free) for the foreign-status inputs noted below. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.
The components and materials sourced from abroad include: Compound stabilizer for plastics; antimony trioxide (low-tint); flat release paper; polyester knit fabric; polycotton
The request indicates that CGT will admit foreign-status polyester and polycotton knit fabrics (HTSUS 6006.31.00) in privileged foreign status (19 CFR 146.43), thereby precluding inverted tariff benefits on these inputs.
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 December 14, 2016.
A copy of the notification 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 Diane Finver at
An application has been submitted to the Foreign-Trade Zones Board (the Board) by the New Jersey Department of State, grantee of FTZ 44, requesting subzone status for the facility of AGFA Corporation, located in Branchburg, New Jersey. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the Board (15 CFR part 400). It was formally docketed on October 28, 2016.
The proposed subzone (39 acres) is located at 50 Meister Avenue, Branchburg. A notification of proposed production activity has been submitted and will be published separately for public comment. The proposed subzone would be subject to the existing activation limit of FTZ 44.
In accordance with the Board's regulations, Kathleen Boyce of the FTZ Staff is designated examiner to review the application and make recommendations to the Executive Secretary.
Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is December 14, 2016. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to December 29, 2016.
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 Board's Web site, which is accessible via
For further information, contact Kathleen Boyce at
Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C. 81a-81u), the Foreign-Trade Zones Board (the Board) adopts the following Order:
On June 13, 2016, the State of New Jersey, Department of State, grantee of FTZ 44, submitted a notification of proposed production activity to the Foreign-Trade Zones (FTZ) Board on behalf of Givaudan Flavors Corporation, within Subzone 44H in East Hanover, New Jersey.
The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (“Department”) preliminarily determines that 1-Hydroxyethylidene-1, 1-Diphosphonic Acid (“HEDP”) from the People's Republic of China (“PRC”) is being, or is likely to be, sold in the United States at less than fair value (“LTFV”), as provided in section 733 of the Tariff Act of 1930, as amended (“the Act”). The period of investigation (“POI”) is July 1, 2015 through December 31, 2015. The estimated weighted-average dumping margins are shown in the “Preliminary Determination” section of this notice. Interested parties are invited to comment on this preliminary determination.
Effective November 4, 2016.
Omar Qureshi or Kenneth Hawkins, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-5307 or (202) 482-6491, respectively.
The Department published the notice of initiation of this investigation on April 28, 2016.
The product covered by this investigation is HEDP from the PRC. For a full description of the scope of this investigation,
In accordance with the preamble to the Department's regulations,
The Department is conducting this investigation in accordance with section 731 of the Act. We calculated export prices and constructed export prices in accordance with section 772 of the Act. Because the PRC is a non-market economy within the meaning of section 771(18) of the Act, we calculated normal value (“NV”) in accordance with section 773(c) of the Act. In addition, the Department relied on adverse facts available under sections 776(a) and (b) of the Act. Specifically, the Department did not receive timely responses to its Q&V questionnaire or separate rate applications from numerous PRC exporters and/or producers of merchandise under consideration that were named in the Petition and to whom the Department issued Q&V questionnaires.
In the
The Department preliminarily determines that the following weighted-average dumping margins exist during the POI:
In calculating rates for non-individually investigated respondents in the context of non-market economy cases, the Department looks to section 735(c)(5)(A)-(B) of the Act, which provides instructions for calculating the all-others rate in an investigation. Section 735(c)(5)(A) of the Act provides that the estimated all-others rate shall be equivalent to the weighted average of the estimated weighted-average dumping margins calculated for exporters and producers individually investigated, excluding any margins that are zero,
Apart from the mandatory respondents in this investigation, two other PRC exporters of the subject merchandise during the POI established entitlement to a separate rate.
In accordance with section 733(d)(2) of the Act, the Department will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of all entries of HEDP from the PRC, as described in the “Scope of the Investigation” section, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
Pursuant to section 733(d)(1)(B) of the Act and 19 CFR 351.205(d), the Department will instruct CBP to require a cash deposit
We normally adjust antidumping duty cash deposit rates by the amount of export subsidies, where appropriate. In the companion CVD investigation, we preliminarily found that the WW Group did not receive export subsidies.
Pursuant to section 777A(f) of the Act, we normally adjust preliminary cash deposit rates for estimated domestic subsidy pass-through, where appropriate. However, in this case there is no basis to grant a domestic subsidy pass-through adjustment.
We intend to disclose the calculations performed to interested parties in this proceeding within five days of the date of announcement of this preliminary determination in accordance with 19 CFR 351.224(b). Interested parties may submit case briefs, rebuttal briefs, and hearing requests.
In accordance with section 733(f) of the Act, we will notify the ITC of our affirmative preliminary determination of sales at LTFV. If our final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after our final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.
Section 735(a)(2) of the Act provides that a final determination may be postponed until not later than 135 days after the date of the publication of the preliminary determination if, in the event of an affirmative preliminary determination, a request for such postponement is made by exporters who account for a significant proportion of exports of the subject merchandise, or in the event of a negative preliminary determination, a request for such postponement is made by Petitioners. 19 CFR 351.210(e)(2) requires that requests by respondents for postponement of a final antidumping determination be accompanied by a request for extension of provisional measures from a four-month period to a period not more than six months in duration.
On October 19 and 20, 2016, pursuant to 19 CFR 351.210(b) and (e), the WW Group and Taihe, respectively, requested that, contingent upon an affirmative preliminary determination of sales at LTFV, the Department postpone the final determination and that provisional measures be extended to a period not to exceed six months.
In accordance with section 735(a)(2)(A) of the Act and 19 CFR 351.210(b)(2)(ii), because (1) our preliminary determination is affirmative; (2) the requesting exporters account for a significant proportion of exports of the subject merchandise; and (3) no compelling reasons for denial exist, we are postponing the final determination and extending the provisional measures from a four-month period to a period not greater than six months. Accordingly, we will make our final determination no later than 135 days after the date of publication of this preliminary determination, pursuant to section 735(a)(2) of the Act.
This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).
The merchandise covered by this investigation includes all grades of aqueous acidic (non-neutralized) concentrations of 1-hydroxyethylidene-1, 1-diphosphonic acid (HEDP), also referred to as hydroxyethylidenendiphosphonic acid, hydroxyethanediphosphonic acid, acetodiphosphonic acid, and etidronic acid. The CAS (Chemical Abstract Service) registry number for HEDP is 2809-21-4.
The merchandise subject to this investigation is currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) at subheading 2931.90.9043. It may also enter under HTSUS subheadings 2811.19.6090 and 2931.90.9041. While HTSUS subheadings and the CAS registry number are provided for convenience and customs purposes only, the written description of the scope of this investigation is dispositive.
International Trade Administration, U.S. Department of Commerce.
Notice of an Open Meeting.
The United States Travel and Tourism Advisory Board (Board) will hold an open meeting on Friday, November 18, 2016. The Board was re-chartered in August 2015 and advises the Secretary of Commerce on matters relating to the U.S. travel and tourism industry. The purpose of the meeting is for Board members to discuss and prioritize longer-term travel and tourism issues and considerations regarding recommendations from the Board. The final agenda will be posted on the Department of Commerce Web site for the Board at
Friday, November 18, 2016. The deadline for members of the public to register, including requests to make comments during the meeting and for auxiliary aids, or to submit written comments for dissemination prior to the meeting, is 5 p.m. EDT on November 11, 2016.
The meeting will be held at Dulles International Airport, 1 Saarinen Cir, Dulles, VA 20166.
Requests to register (including to speak or for auxiliary aids) and any written comments should be submitted to: U.S. Travel and Tourism Advisory Board, U.S. Department of Commerce, Room 4043, 1401 Constitution Avenue NW., Washington, DC 20230,
Li Zhou, the United States Travel and Tourism Advisory Board, Room 4043, 1401 Constitution Avenue NW., Washington, DC 20230, telephone: 202-482-4501, email:
In addition, any member of the public may submit pertinent written comments concerning the Board's affairs at any time before or after the meeting. Comments may be submitted to Li Zhou at the contact information indicated above. To be considered during the meeting, comments must be received no later than 5:00 p.m. EDT on Friday, November 11, 2016, to ensure transmission to the Board prior to the meeting. Comments received after that date and time will be distributed to the members but may not be considered on the call. Copies of Board meeting minutes will be available within 90 days of the meeting.
Enforcement and Compliance, International Trade Administration Department of Commerce.
Effective November 4, 2016.
Stephanie Moore, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Ave. NW., Washington, DC 20230, telephone: (202) 482-3692.
Section 702 of the Trade Agreements Act of 1979 (as amended) (the Act) requires the Department of Commerce (the Department) to determine, in consultation with the Secretary of Agriculture, whether any foreign government is providing a subsidy with respect to any article of cheese subject to an in-quota rate of duty, as defined in section 702(h) of the Act, and to publish quarterly updates to the type and amount of those subsidies. We hereby provide the Department's quarterly update of subsidies on articles of cheese that were imported during the periods April 1, 2016, through June 30, 2016.
The Department has developed, in consultation with the Secretary of Agriculture, information on subsidies, as defined in section 702(h) of the Act, being provided either directly or indirectly by foreign governments on articles of cheese subject to an in-quota rate of duty. The appendix to this notice lists the country, the subsidy program or programs, and the gross and net amounts of each subsidy for which information is currently available. The Department will incorporate additional programs which are found to constitute subsidies, and additional information on the subsidy programs listed, as the information is developed.
The Department encourages any person having information on foreign government subsidy programs which benefit articles of cheese subject to an in-quota rate of duty to submit such information in writing to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, 14th Street and Constitution Ave. NW., Washington, DC 20230.
This determination and notice are in accordance with section 702(a) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Brenda E. Waters, Office of AD/CVD Operations, Customs Liaison Unit, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230, telephone: (202) 482-4735.
Each year during the anniversary month of the publication of an antidumping or countervailing duty order, finding, or suspended investigation, an interested party, as defined in section 771(9) of the Tariff Act of 1930, as amended (“the Act”), may request, in accordance with 19 CFR 351.213, that the Department of Commerce (“the Department”) conduct an administrative review of that antidumping or countervailing duty order, finding, or suspended investigation.
All deadlines for the submission of comments or actions by the Department discussed below refer to the number of calendar days from the applicable starting date.
In the event the Department limits the number of respondents for individual examination for administrative reviews initiated pursuant to requests made for the orders identified below, the Department intends to select respondents based on U.S. Customs and Border Protection (“CBP”) data for U.S. imports during the period of review. We intend to release the CBP data under Administrative Protective Order (“APO”) to all parties having an APO within five days of publication of the initiation notice and to make our decision regarding respondent selection within 21 days of publication of the initiation
In the event the Department decides it is necessary to limit individual examination of respondents and conduct respondent selection under section 777A(c)(2) of the Act:
In general, the Department finds that determinations concerning whether particular companies should be “collapsed” (
Pursuant to 19 CFR 351.213(d)(1), a party that requests a review may withdraw that request within 90 days of the date of publication of the notice of initiation of the requested review. The regulation provides that the Department may extend this time if it is reasonable to do so. In order to provide parties additional certainty with respect to when the Department will exercise its discretion to extend this 90-day deadline, interested parties are advised that, with regard to reviews requested on the basis of anniversary months on or after November 2016, the Department does not intend to extend the 90-day deadline unless the requestor demonstrates that an extraordinary circumstance prevented it from submitting a timely withdrawal request. Determinations by the Department to extend the 90-day deadline will be made on a case-by-case basis.
The Department is providing this notice on its Web site, as well as in its “Opportunity to Request Administrative Review” notices, so that interested parties will be aware of the manner in which the Department intends to exercise its discretion in the future.
Not later than the last day of November 2016,
In accordance with 19 CFR 351.213(b), an interested party as defined by section 771(9) of the Act may request in writing that the Secretary conduct an administrative review. For both antidumping and countervailing duty reviews, the interested party must specify the individual producers or exporters covered by an antidumping finding or an antidumping or countervailing duty order or suspension agreement for which it is requesting a review. In addition, a domestic interested party or an interested party described in section 771(9)(B) of the Act must state why it desires the Secretary to review those particular producers or exporters. If the interested party intends for the Secretary to review sales of merchandise by an exporter (or a producer if that producer also exports merchandise from other suppliers) which was produced in more than one country of origin and each country of origin is subject to a separate order, then the interested party must state specifically, on an order-by-order basis, which exporter(s) the request is intended to cover.
Note that, for any party the Department was unable to locate in prior segments, the Department will not accept a request for an administrative review of that party absent new information as to the party's location. Moreover, if the interested party who files a request for review is unable to locate the producer or exporter for which it requested the review, the interested party must provide an explanation of the attempts it made to locate the producer or exporter at the same time it files its request for review, in order for the Secretary to determine if the interested party's attempts were reasonable, pursuant to 19 CFR 351.303(f)(3)(ii).
As explained in
Further, as explained in
All requests must be filed electronically in Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (“ACCESS”) on Enforcement and Compliance's ACCESS Web site at
The Department will publish in the
For the first administrative review of any order, there will be no assessment of antidumping or countervailing duties on entries of subject merchandise entered, or withdrawn from warehouse, for consumption during the relevant provisional-measures “gap” period of the order, if such a gap period is applicable to the period of review.
This notice is not required by statute but is published as a service to the international trading community.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of permit amendment.
Notice is hereby given that Alaska Department of Fish and Game (ADF&G), Division of Wildlife Conservation, Juneau, AK (Responsible Party: Robert Small, Ph.D.) has been issued a minor amendment to Scientific Permit No. 15324.
The amendment and related documents are available for review upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.
Sara Young or Amy Sloan, phone (301) 427-8401.
The requested amendment has been granted under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361
The original permit (No. 15324), issued on May 25, 2011 (76 FR 30309) authorized taking spotted (
National Ocean Service, National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.
Notice of open meeting (via teleconference).
Notice is hereby given of a virtual meeting of the U.S. Integrated Ocean Observing System (IOOS®) Advisory Committee (Committee).
The public meeting will be held on Tuesday, November 22, 2016, from 3:00 p.m. to 4:00 p.m. ET. These times and the agenda topics described below are subject to change. Refer to the Web page listed below for the most up-to-date meeting agenda.
Jessica Snowden, Designated Federal Official, U.S. IOOS Advisory Committee, U.S. IOOS Program, 1315 East-West Highway, 2nd Floor, Silver Spring, MD 20910, Silver Spring, MD 20910; Phone 240-533-9466; Fax 301-713-3281; Email
The Committee meeting will be held via teleconference. Members of the public who wish to participate in the meeting must register in advance by 5:00 p.m. ET on November 21. 2016. Please
The Committee was established by the NOAA Administrator as directed by Section 12304 of the Integrated Coastal and Ocean Observation System Act, part of the Omnibus Public Land Management Act of 2009 (Pub. L. 111-11). The Committee advises the NOAA Administrator and the Interagency Ocean Observation Committee (IOOC) on matters related to the responsibilities and authorities set forth in section 12302 of the Integrated Coastal and Ocean Observation System Act of 2009 and other appropriate matters as the Under Secretary refers to the Committee for review and advice.
The Committee will provide advice on:
(a) administration, operation, management, and maintenance of the System;
(b) expansion and periodic modernization and upgrade of technology components of the System;
(c) identification of end-user communities, their needs for information provided by the System, and the System's effectiveness in dissemination information to end-user communities and to the general public; and
(d) any other purpose identified by the Under Secretary of Commerce for Oceans and Atmosphere or the Interagency Ocean Observation Committee.
The meeting will be open to public participation with a 10-minute public comment period on November 22, 2016, from 3:45 p.m. to 3:55 p.m. (check agenda on Web site to confirm time.) The Committee expects that public statements presented at its meetings will not be repetitive of previously submitted verbal or written statements. In general, each individual or group making a verbal presentation will be limited to a total time of three (3) minutes. Written comments should be received by the Designated Federal Official by November 18, 2016 to provide sufficient time for Committee review. Written comments received after November 18, 2016, will be distributed to the Committee, but may not be reviewed prior to the meeting date.
Committee for Purchase From People Who Are Blind or Severely Disabled.
Addition to the Procurement List.
This action adds a service to the Procurement List that will be provided by a nonprofit agency employing persons who are blind or have other severe disabilities.
Effective on December 4, 2016.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia, 22202-4149.
Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
On 10/7/2016 (81 FR 69789-69790), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed addition to the Procurement List.
After consideration of the material presented to it concerning capability of qualified nonprofit agency to provide the service and impact of the addition on the current or most recent contractors, the Committee has determined that the service listed below is suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organization that will provide the service to the Government.
2. The action will result in authorizing small entities to provide the service to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the service proposed for addition to the Procurement List.
Accordingly, the following service is added to the Procurement List:
Committee for Purchase From People Who Are Blind or Severely Disabled.
Proposed Addition to and Deletions from the Procurement List.
The Committee is proposing to add a service to the Procurement List that will be furnished by nonprofit agency employing persons who are blind or have other severe disabilities and, deletes a product and services previously furnished by such agencies.
Comments must be received on or before December 4, 2016.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia, 22202-4149.
Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
If the Committee approves the proposed addition, the entities of the Federal Government identified in this notice will be required to procure the
The following service is proposed for addition to the Procurement List for production by the nonprofit agency listed:
The following product and services are proposed for deletion from the Procurement List:
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 to renew the Office of Management and Budget (OMB) approval for an existing information collection titled, “Truth In Lending Act (Regulation Z)—Appraisals For Higher-Priced Mortgage Loans.”
Written comments are encouraged and must be received on or before January 3, 2017 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:
•
•
•
Documentation prepared in support of this information collection request is available at
Corporation for National and Community Service.
Notice.
The Corporation for National and Community Service (CNCS) has submitted a public information collection request (ICR) entitled AmeriCorps Affiliate Application Instructions for review and approval in accordance with the Paperwork Reduction Act of 1995, Public Law 104-13, (44 U.S.C. Chapter 35). Copies of this ICR, with applicable supporting documentation, may be obtained by calling the Corporation for National and Community Service, Patti Stengel, at 202-606-6745 or email to
Comments may be submitted, identified by the title of the information collection activity, within December 5, 2016.
Comments may be submitted, identified by the title of the information collection activity, to the Office of Information and Regulatory Affairs, Attn: Ms. Sharon Mar, OMB Desk Officer for the Corporation for National and Community Service, by any of the following two methods within 30 days from the date of publication in the
(1)
(2)
The OMB is particularly interested in comments which:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of CNCS, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Propose ways to enhance the quality, utility, and clarity of the information to be collected; and
• Propose ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
A 60-day Notice requesting public comment was published in the
Department of the Army, DOD.
Notice.
The Military Surface Deployment and Distribution Command (SDDC) will officially have an Open Season, effective 09 Jan 17 thru 28 Feb 17 (Applications will not be accepted prior to 9 Jan 17). This will affect domestic motor Transportation Service Providers (TSPs) only. TSPs must be registered in the Federal Motor Carrier Safety Administration (FMSCA) and have valid Department of Transportation (DOT) authority for three (3) consecutive years (without a break) prior to the 09 Jan 17. New TSPs will indicate their small business status via the Freight Carrier Registration Program (FCRP) during registration. Registration for other modes will continue to be accepted (barge, ocean, pipeline, and international carriers).
Submit comments to Military Surface Deployment and Distribution Command, ATTN: AMSSD-OPM, 1 Soldier Way, Scott AFB, IL 62225-5006. Request for additional information may be sent by email to:
FCRP Team, (618) 220-6470.
Office of the Under Secretary of Defense (Acquisition, Technology, and Logistics), Department of Defense (DoD).
Federal advisory committee meeting notice.
The Department of Defense is publishing this notice to announce the following Federal advisory committee meeting of the Government-Industry Advisory Panel. This meeting is open to the public.
The meeting will be held from 9:00 a.m. to 5:00 p.m. on Thursday, November 10, 2016. Public registration will begin at 8:45 a.m. For entrance into the meeting, you must meet the necessary requirements for entrance into the Pentagon. For more detailed information, please see the following link:
Pentagon Library, Washington Headquarters Services, 1155 Defense Pentagon, Washington, DC 20301-1155. The meeting will be held in Room B10. The Pentagon Library is located in the Pentagon Library and Conference Center (PLC2) across the Corridor 8 bridge.
LTC Andrew Lunoff, Office of the Assistant Secretary of Defense (Acquisition), 3090 Defense Pentagon, Washington, DC 20301-3090, email:
Due to circumstances beyond the control of the Designated Federal Officer and the Department of Defense, the Government-Industry Advisory Panel is unable to provide public notification, as required by 41 CFR 102-3.150(a), for its meeting on Thursday, November 10, 2016. Accordingly, the Advisory Committee Management Officer for the Department of Defense, pursuant to 41 CFR 102-3.150(b), waives the 15-calendar day notification requirement.
Minor changes to the agenda will be announced at the meeting. All materials will be posted to the FACA database after the meeting.
Individuals requiring special accommodations to access the public meeting or seeking additional information about public access procedures, should contact LTC Lunoff, the committee DFO, at the email address or telephone number listed in the
Office of the Assistant Secretary of Defense for Health Affairs, DoD.
Notice.
In compliance with the
Consideration will be given to all comments received by January 3, 2017.
You may submit comments, identified by docket number and title, by any of the following methods:
•
•
Any associated form(s) for this collection may be located within this same electronic docket and downloaded for review/testing. Follow the instructions at
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to Mr. Doug McBroom, Defense Health Agency, TRICARE Policy & Benefits Office, 7700 Arlington Blvd., Suite 5101, Falls Church, VA 22042-5101, telephone 303-676-3533.
Respondents are limited to employers who make available non-contributory TRICARE supplemental insurance plan to their employees. One certification must be completed per employer and kept on file by the employer for as long as such plans are offered.
Department of Defense, Defense Security Cooperation Agency.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Chang Suh, DSCA/SA&E/RAN, (703) 697-8975.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 16-49 with attached Policy Justification and Sensitivity of Technology.
(i)
(ii)
(iii)
(iv)
(v)
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(viii)
* as defined in Section 47(6) of the Arms Export Control Act.
The Government of Egypt has requested a possible sale of:
This request also includes the following Non-MDE: OCONUS Installation/Integration, Installation Mounting Kits, Countermeasure Dispenser Test Set AN/ALM-294, Technical Assistance, U.S. Government Training and OCONUS Contractor Training, publications and technical documents, quality assurance and other related elements of logistics and program support. The estimated cost is $81.4 million.
This proposed sale will contribute to the foreign policy and national security of the United States by helping to improve the security of a strategic partner that has been and continues to be an important force for political stability and economic progress in the Middle East.
The proposed sale of the CMWS will equip the Egyptian Air Force's fleet of multi mission helicopters with a detection system for infrared missile threats. Egypt will have no difficulty absorbing this equipment into its armed forces.
The proposed sale of this equipment and support will not alter the basic military balance in the region.
The prime contractors will be BAE Systems and DynCorp. There are no known offset agreements proposed in connection with this potential sale.
Implementation of this proposed sale will require the assignment of two (2) U.S. Government and two (2) contractor representatives to Egypt to support delivery of such equipment, installation and integration, maintenance and to provide technical support and equipment familiarization. Additionally, this program will require multiple trips involving U.S. Government and contractor personnel to participate in technical reviews, training and installation.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
(vii)
1. AN/AAR-57—Common Missile Warning System (CMWS)—The Common Missile Warning System (CMWS) provides superior detection of infrared missile threats for rotary-wing, transport, and tactical aircraft. It is the detection component of a suite of countermeasures to increase survivability of current generation combat, airlift, and special operations aircraft against the threat posed by infrared guided missiles. It also provides automatic, passive missile detection, threat declaration, crew warning, software reprograming, false alarm suppression and cues to other on-board systems, such as dispensers, which may be utilized for flare decoys. Each platform includes: Electro-optical Missile Sensors, and Electronic Control Unit (ECU), Sequencer, and the Improved Countermeasures Dispenser (ICMD). The ECU hardware is classified CONFIDENTIAL; releasable technical manuals for operation and maintenance are classified SECRET.
2. If a technologically advanced adversary were to obtain knowledge of the specific hardware and software equipment, the information could be used to develop countermeasures or equivalent systems which may reduce weapon system effectiveness or be used in the development of a system with similar or advanced capabilities.
3. A determination has been made that Egypt can provide substantially the same degree of protection for this technology as the U.S. Government. This proposed sale is necessary in furtherance of the U.S. foreign policy and national security objectives outlined in the Policy Justification.
4. All defense articles and services listed in this transmittal have been authorized for release and export to Egypt.
Defense Security Cooperation Agency, Department of Defense.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Chang Suh, DSCA/SA&E/RAN, (703) 697-8975.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 16-37 with attached Policy Justification and Sensitivity of Technology.
(i)
(ii) Total Estimated Value:
(iii)
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* as defined in Section 47(6) of the Arms Export Control Act.
The Government of Egypt has requested a possible sale of eight (8) Sentinel AN/MPQ-64F1 Radars and software and training, as well as spares and support equipment, technical manuals, Single Channel Ground and Airborne Radio System (SINCGARS) VRC-92E Radios, 16 High Mobility Multipurpose Wheeled Vehicles (HMMWV) Ml 152 with Shelter Carrier Kit, U.S. Government and contractor support, training and other associated support, equipment and services. The total estimated value of MDE is $40 million. The total overall estimated cost is $70 million.
This proposed sale will contribute to the foreign policy and national security of the United States by helping to improve the security of a strategic partner that has been and continues to be an important force for political stability and economic progress in the Middle East.
The Government of Egypt intends to expand its existing air defense architecture to counter threats posed by air attack. This will contribute to Egypt's military goal of updating its capabilities while further enhancing interoperability among Egypt, the United States, and other allies. Egypt will have no difficulty absorbing this equipment into its armed forces.
The proposed sale of this equipment and support will not alter the basic military balance in the region.
The principal contractor involved in this program is Thales Raytheon Systems, Fullerton, California. There are no known offset agreements proposed in connection with this potential sale.
Implementation of this proposed sale will require ten (10) U.S. Government or contractor representatives to travel to Egypt for a period of 8 weeks for equipment checkout and training.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
(vii)
1. The AN/MPQ-64 Sentinel Radar System is a fielded air defense radar system in the Army inventory. Sentinel is a derivative of the AN/TPQ-36 Firefinder System used for artillery detection and the AN/TPQ-36A Norwegian adapted Hawk system. The Sentinel radar (AN/MPQ-64) is the sensor for the Short Range Air Defense (SHORAD) weapon systems, including the Avenger and any ground launcher Stinger platforms. Sentinel is a mobile phased array radar that provides highly accurate 3 dimensional radar track data to using systems via the Forward Area Air Defense (FAAD) Command, Control, and Intelligence (C2I) node. Sentinel's detection range, mobility, and 360 degree azimuth coverage allow it to support SHORAD weapons located throughout the division area. Sentinel acquires, tracks, and reports cruise missiles, unmanned aerial vehicles, fixed and rotary wing aircraft in clutter and electronic counter measures environments. The Sentinel Export configuration (AN/MPQ-64Fl) is a derivative of the U.S. Army's Improved Sentinel Radar.
2. The Sentinel consists of a radar-based sensor system with the Ml 152 HMMWV as the prime mover and the MEP-1041 Advanced Mobile Medium Power Source (AMMPS) Tactical Quiet Generator as the power source. The sensor is an advanced battlefield radar capable of X-Band air defense phased-array with an instrumented range of 75 kilometers with a rotating antenna providing 360 degree azimuth coverage for acquisition and tracking.
3. Sentinel has only one item currently designated Critical Program Information (CPI) and that is the Sentinel software modules containing routines for electronic counter-counter measures (ECCM) that have been determined to be CPI.
4. These items are classified IAW EO 12958 section 1.5, Classification categories as category 1.5(e) because they contain scientific, technological, or economic matters relative to the national security. Reports, test data, and all Sentinel related media that discloses operational parameters, performance, characteristics, ECCM techniques, vulnerabilities, limitations or performance weaknesses shall be classified at the highest level based on the information being conveyed as referenced in the Sentinel Security Classification Guide. Distribution of technical performance and system capabilities reports and data shall only be released up to the CONFIDENTIAL level. It is not possible to obtain the Sentinel wartime reserved frequencies by reverse engineering, testing, or analyzing the unclassified Sentinel end item.
5. All defense articles and services listed in this transmittal are authorized for release and export to the Government of Egypt.
Department of Defense.
Renewal of Federal Advisory Committee.
The Department of Defense (DoD) is publishing this notice to announce that it is renewing the charter for the Department of Defense Wage Committee (“the Committee”).
Jim Freeman, Advisory Committee Management Officer for the Department of Defense, 703-692-5952.
The Committee's charter is being renewed in accordance with the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended) and 41 CFR 102-3.50(a). The Committee's charter and contact information for the Committee's Designated Federal Officer (DFO) can be found at
The Committee is composed of seven members—a chair and six additional members. The remaining six positions consist of two labor organization representatives and four members who are regular government employees (RGE) and are divided into two broad categories—labor and management.
The public or interested organizations may submit written statements to the Committee membership about the Committee's mission and functions. Written statements may be submitted at any time or in response to the stated agenda of planned meeting of the Committee. All written statements shall be submitted to the DFO for the Committee, and this individual will ensure that the written statements are provided to the membership for their consideration.
Defense Security Cooperation Agency, Department of Defense.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Chang Suh, DSCA/SA&E/RAN, (703) 697-8975.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 16-45 with attached Policy Justification.
(i) (U)
(ii) (U)
(iii) (U)
The United Arab Emirates Air Force requests participation in military exercises, aerial refueling, airlift and ferry support, training aids/devices/munitions, technical and logistics support services, and other related elements of logistical and program support. There is no MDE associated with this potential sale. The total estimated cost is $75.0 million.
(iv) (U)
(v) (U)
(vi) (U)
(vii) (U)
(viii) (U)
* as defined in Section 47(6) of the Arms Export Control Act.
(U) The Government of the UAE requested a possible sale to include participation in military exercises, aerial refueling, airlift and ferry support, training aids/devices/munitions, technical and logistics support services, and other related elements of logistical and program support. The estimated cost is $75 million.
(U) This proposed sale contributes to the foreign policy and national security of the United States by helping to improve the security of a major regional ally which has been, and continues to be, an important force for political stability and economic progress in the Middle East.
(U) This proposed sale contributes to the foreign policy and national security of the United States by helping to improve the ability of the UAE to employ its fighter aircraft in a multi-country coalition environment, such as Red Flag and Green Flag exercises. Participating in major exercises has enhanced the UAE's continued and consistent role in support of Coalition Operations. The UAE is a steadfast coalition partner in the fight against radical Islamic forces such as ISIL and Al Qaeda (AQAP) in the Arabian Peninsula.
(U) The proposed sale of this equipment and support does not alter the basic military balance in the region.
(U) Implementation of this proposed sale will not require the assignment of any additional U.S. Government or contractor representatives to the UAE.
(U) There will be no adverse impact on U.S. defense readiness as a result of this proposed sale. All defense articles and services are approved for release by our foreign disclosure office.
Defense Security Cooperation Agency, Department of Defense.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Chang Suh, DSCA/SA&E/RAN, (703) 697-8975.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 16-38 with attached Policy Justification.
(i)
(ii)
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* as defined in Section 47(6) of the Arms Export Control Act.
The Government of Kuwait has requested a possible total sale of six (6) Short Range Radars, otherwise known as Gap Filler Radars, one (1) Long Range Radar with Primary Surveillance Radar (PSR) and Secondary Surveillance Radar (SSR) arrays, upgrades to existing AN/FPS 117 (V) 3 Long Range Radar, upgrades to airfield radome and communications systems, upgrade to secure Identification Friend or Foe (IFF) systems, site surveys, installation and checkout, site acceptance testing, interim contractor support, construction, contractor logistics support, spares, support equipment, and training. The total estimated value of this sale is $194 million.
The Government of Kuwait requested a limited competition between three (3) U.S. vendors to procure a total of six (6) Short Range, Gap Filler Radars (e.g., AN/MPQ-64 Sentinel F1, AN/TPS-77, or AN/TPS-703) and one (1) Long Range Radar (e.g., AN/TPS-77 or AN/TPS-78). Only one of the radars under consideration, the AN/MPQ-64 is Major Defense Equipment (MDE). The remaining radars identified by Kuwait for consideration are non-MDE.
This proposed sale supports U.S. Government national security goals by aiding a Major non-NATO Ally in the reduction of transnational threats, weapons proliferation, and the movement and support of international terrorists.
The Government of Kuwait desires the radar field system in order to improve early warning, enhance internal and external security, and protect national sovereignty. The system provides situational awareness for Kuwaiti security forces to detect and interdict fixed and rotary wing aircraft. This procurement provides coverage for Kuwait's northern and eastern boarders.
The prime contractor will be determined by competition between Lockheed Martin, Bethesda Maryland, Northrop Grumman, Falls Church, Virginia, and the Raytheon Company, Waltham, Massachusetts. There are no known offset agreements proposed in connection with this potential sale.
This procurement includes a small number of U.S. contractor system and maintenance advisors under a long-term operations and maintenance support package. The exact number of personnel and period of performance is yet to be finalized. This purchase will not substantially alter the U.S. Government presence in Kuwait.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
(vii)
1. The AN/MPQ-64 Sentinel Radar System is a fielded air defense radar system in the Army inventory. Sentinel is a derivative of the AN/TPQ-36 Firefinder System used for artillery detection and the AN/TPQ-36A Norwegian adapted Hawk system. Sentinel is a mobile, phased-array radar that provides highly accurate 3 dimensional radar track data to using systems via the Forward Area Air Defense (FAAD) Command, Control, and Intelligence (C2I) node. Sentinel acquires, tracks, and reports cruise missiles, unmanned aerial vehicles, fixed and rotary wing aircraft in clutter and electronic counter measures environments. The Sentinel Export configuration (AN/MPQ-64Fl) is a derivative of the U.S. Army's Improved Sentinel Radar.
2. The Sentinel consists of a radar-based sensor system with the M1152 HighMobility Multipurpose Wheeled Vehicle (HMMWV) as the prime mover and the MEP-1041 Advanced Mobile Medium Power Source (AMMPS) Tactical Quiet Generator as the power source. The sensor is an advanced battlefield radar capable of X Band air defense phased-array with an instrumented range of 75 kilometers with a rotating antenna providing 360 degree azimuth coverage for acquisition and tracking.
3. Sentinel has only one item currently designated Critical Program Information (CPI) and that is the Sentinel software modules containing routines for electronic counter-counter measures (ECCM) that have been determined to be a CPI.
4. These items are classified IAW EO 12958 section 1.5, Classification categories as category 1.5(e) because they contain scientific, technological, or economic matters relative to the national security. Reports, test data, and all Sentinel related media that discloses operational parameters, performance, characteristics, ECCM techniques, vulnerabilities, limitations or performance weaknesses shall be classified at the highest level based on the information being conveyed as referenced in the Sentinel Security Classification Guide. Distribution of technical performance and system capabilities reports and data shall only be released up to the CONFIDENTIAL level. It is not possible to obtain the Sentinel wartime reserved frequencies by reverse engineering, testing, or analyzing the unclassified Sentinel end item.
5. This sale is necessary in furtherance of the U.S. foreign policy and national security objectives outlined in the Policy Justification. Moreover, the benefits to be derived from this sale, as outlined in the Policy Justification, outweigh the potential damage that could result if the sensitive technology were revealed to unauthorized persons.
6. All defense articles and services listed in this transmittal are authorized for release and export to the Government of Kuwait.
Department of the Army, U.S. Army Corps of Engineers, DOD.
Notice of intent.
In accordance with the National Environmental Policy Act
The public scoping meeting dates are:
1. November 21, 2016, at 1:30 p.m. and 6:30 p.m. in the Hubbard Auditorium of the Tioga County Office Building.
2. November 22, 2016 at 1:30 p.m. and 6:30 p.m. at the Town of Chenango Community Meeting Room.
3. November 30, 2016, at 6:30 p.m. in the Village of Sidney.
Two scoping meetings will be held in the Village of Owego on Monday, November 21, 2016, at 1:30 p.m. and 6:30 p.m. in the Hubbard Auditorium of the Tioga County Office Building, 56 Main Street. Two scoping meetings will be held in the Town of Chenango on Tuesday, November 22, 2016 at 1:30 p.m. and 6:30 p.m. at the Town of Chenango Community Meeting Room at 1529 Upper Front Street (NY Route 12). One meeting will be held on November 30, 2016, at 6:30 p.m. in the Village of Sidney in the Memorial Public Library located at 8 River Street.
Questions about the proposed scoping meetings, requests to be placed on the project information distribution list, information requests or written comments on the scope of the EIS and the comprehensive FRM study can be addressed to Mr. David W. Robbins, U.S. Army Corps of Engineers, ATTN: CENAB-PL-P, 10 S. Howard Street, Baltimore, MD 21201, telephone 410-962-0685; email address:
This Notice initiates formal scoping for the Environmental Impact Statement (EIS), provides information on the nature of the proposed Project, invites participation in the EIS process, and identifies potential environmental effects to be considered. It also invites comments from interested members of the public, tribes, and agencies on the scope of the EIS and announces upcoming public scoping meetings. Comments should address (1) feasible alternatives that may better achieve the Project's need and purposes with fewer adverse impacts and (2) any significant environmental impacts relating to the alternatives.
Scoping meeting information will be posted online by Baltimore District via Web site postings and social media. Meeting information will be provided electronically via the study's Web page and in printed form to local libraries, government offices, as well as mailed to interested public.
For all meetings, staff will be available to answer questions. All interested parties are invited to speak at the public meetings. The public scoping peiod will begin on the date of publication of this Notice and will continue through 30 days following the last public scoping meeting.
The study was authorized by a Resolution of the House Committee on Transportation and Infrastructure, on 24 September, 2008. The upper Susquehanna Basin includes the portions of Tioga, Broome, Chenango, Cortland, Otsego, Delaware, Schoharie, Herkimer, Oneida, Madison, Onondaga, Tompkins, Schuyler, and Chemung Counties in the Susquehanna River Watershed of New York upstream of the Chemung River confluence near Waverly. The upper Susquehanna River Basin repeatedly experiences flooding damages, with recent notable events occurring in 2006 and 2011. USACE is undertaking the FRM study in partnership with the New York State Department of Environmental Conservation (NYSDEC).
USACE and NYSDEC are seeking public input to identify areas with flooding concerns which may be of interest to address in the context of the study, and learn of area-specific considerations important in formulating any FRM plans. Study efforts will be coordinated with the Federal Emergency Management Area (FEMA), the U.S. Geological Survey (USGS), as well as other Federal and state agencies and local governments.
An initial conceptual effort will be completed using existing information to identify areas of the basin that currently do not have FRM infrastructure in place and screen these areas for FRM needs and opportunities. The study will evaluate the level of FRM currently provided by existing FRM infrastructure under current conditions and projected future conditions. Within the study area, there are 20 existing USACE FRM projects, as well as other non-Federal FRM projects. The study will investigate FRM strategies to reduce flood risk, as well as reduce residual risk in areas with existing FRM infrastructure. Structural and non-structural FRM will be considered. Hydrologic and hydraulic modeling will be developed for the majority of the Susquehanna River main stem and major tributaries in the basin to aid plan formulation.
The study will be conducted in compliance with applicable federal laws including the Clean Water Act, the Endangered Species Act, the Clean Air Act, the U.S. Fish and Wildlife Coordination Act, the National Historic Preservation Act, and the Farmland Protection Policy Act. All appropriate compliance documentation will be obtained and included as part of the EIS. It is currently anticipated that the study will take three years and may lead to the implementation of one or more FRM projects. The EIS is expected to be publicly released in Spring 2018.
Department of the Navy, DoD.
Notice.
The Department of the Navy (DoN), after carefully weighing the strategic, operational, and environmental consequences of the proposed action, announces its decision to continue and enhance training activities as identified in Alternative 1 in the Northwest Training and Testing Final Environmental Impact Statement/Overseas Environmental Impact Statement. This alternative includes adjustments to existing training and testing activities, new training and testing activities to support future requirements, and activities not previously analyzed, such as pierside sonar maintenance and testing. Implementation of Alternative 1 will enable the DoN to achieve the levels of operational readiness required under Section 5062 Title 10 U.S.C. without resulting in significant environmental impacts.
The complete text of the Record of Decision is available at
Office of Science, Department of Energy.
Notice of partially-closed meeting.
This notice sets forth the schedule and summary agenda for a partially-closed meeting of the President's Council of Advisors on Science and Technology (PCAST), and describes the functions of the Council. The Federal Advisory Committee Act requires that public notice of these meetings be announced in the
November 18, 2016 9:00 a.m. to 12:00 p.m.
The meeting will be held at the National Academy of Sciences, 2101 Constitution Avenue NW., Washington, DC in the Lecture Room.
Information regarding the meeting agenda, time, location, and how to register for the meeting is available on the PCAST Web site at:
The President's Council of Advisors on Science and Technology (PCAST) is an advisory group of the nation's leading scientists and engineers, appointed by the President to augment the science and technology advice available to him from inside the White House, cabinet departments, and other Federal agencies. See the Executive Order at
The public comment period for this meeting will take place on November 18, 2016 at a time specified in the meeting agenda posted on the PCAST Web site at
Please note that because PCAST operates under the provisions of FACA, all public comments and/or presentations will be treated as public documents and will be made available for public inspection, including being posted on the PCAST Web site.
This is a supplemental notice in the above-referenced proceeding of Quantum Power Corp's application for market-based rate authority, with an
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is November 21, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
On October 31, 2016, the Commission issued an order in Docket No. EL17-10-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e (2012), instituting an investigation into the justness and reasonableness of Midcontinent Independent System Operator, Inc.'s depreciation rates.
The refund effective date in Docket No. EL17-10-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the
Any interested person desiring to be heard in Docket No. EL17-10-000 must file a notice of intervention or motion to intervene, as appropriate, with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rule 214 of the Commission's Rules of Practice and Procedure, 18 CFR 385.214 (2016), within 21 days of the date of issuance of the order.
This is a supplemental notice in the above-referenced proceeding of Innovative Solar 47, LLC `s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is November 21, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and § 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by
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) announces an upcoming meeting for the Clean Air Act Advisory Committee (CAAAC). The EPA established the CAAAC on November 19, 1990, to provide independent advice and counsel to EPA on policy issues associated with implementation of the Clean Air Act of 1990. The Committee advises on economic, environmental, technical, scientific and enforcement policy issues.
The CAAAC will hold its next face-to-face meetings on December 1, 2016 from 08:30 a.m. to 04:30 p.m.
The meeting will take place at the DuPont Circle Hotel, 1500 New Hampshire Avenue NW., Washington, DC 20036.
Any member of the public who wants further information concerning the CAAAC's public teleconference may contact Tamara Saltman of the Office of Air and Radiation, U.S. EPA at
For information on access or services for individuals with disabilities, please contact Lorraine Reddick at
5 U.S.C. App. 2 Section 10(a)(2).
Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at:
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written PRA comments should be submitted on or before January 3, 2017. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
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 2, 2016.
A. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198-0001:
1.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than November 21, 2016.
A. Federal Reserve Bank of Richmond (Adam M. Drimer, Assistant Vice President) 701 East Byrd Street, Richmond, Virginia 23261-4528. Comments can also be sent electronically to or
1.
The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) 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; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to
Cohort Study of HIV, STIs and Preventive Interventions among Young MSM in Thailand—New—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
CDC requests OMB approval for a new three-year information collection.
In Thailand, there is a very high HIV incidence in men who have sex with men (MSM) and transgender women (TGW). It is estimated that over 50% of all new HIV infections are occurring in MSM and TGW. At Silom Community Clinic @Tropical Medicine (SCC @TropMed), there is a reported average HIV prevalence of 28% and HIV incidence of 8 per 100 person-years in young men (YMSM).
Areas with gaps of understanding regarding the HIV epidemic in Thailand, as well as globally, are the epidemiology, risk factors, and HIV beliefs and knowledge of gay identified and transgender youth. In 2013, the Joint United Nations Programme on HIV and AIDS reported that 95% of new HIV infections were in low- and middle-income countries, where more than one third of new infections were among young people (<18 years) who were unaware of their HIV status. Adolescents living with HIV are more likely to die from AIDS, and there is little tracking of the HIV epidemic and outcomes in adolescents.
We propose a study of males aged 15-29 years at risk for HIV. This study includes a longitudinal assessment (cohort) to assess HIV and sexually transmitted infection incidence and prevalence. This study will also generate critical data on HIV and STD incidence and prevalence in young men and adolescent males.
This is the first study of its kind in Bangkok to collect data on HIV and STI incidence, access to HIV prevention, and attitudes about HIV prevention in adolescents ages 15-17 years. In addition to the cohort activities in which young persons are followed over three years, this study will collect needed qualitative data in the form of focus group discussions (FGD), and key informant interviews (KII) from teens and those that serve these teens in the community on HIV prevention, access to testing, pre-exposure prophylaxis or PrEP and other issues relevant to HIV prevention. The qualitative component will assess adolescent and key leaders' HIV prevention knowledge and practices. This study is a five-year study in total, with active follow-up over three years, and a two-year enrollment period.
A study of young men at risk in Thailand is urgently needed to provide necessary data to assess and implement prevention strategies and inform policies for HIV prevention in Thailand, as well as globally. There is no cost to participants other than their time.
The total estimated annualized burden hours are 814.
Centers for Medicare & Medicaid Services, HHS.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the
Comments must be received by January 3, 2017.
When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:
1.
2.
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' Web site address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786-1326.
Reports Clearance Office at (410) 786-1326.
This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see
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. The term “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
1.
2.
3.
Centers for Medicare & Medicaid Services, HHS.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the
Comments on the collection(s) of information must be received by the OMB desk officer by December 5, 2016.
When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' Web site address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786-1326.
Reports Clearance Office at (410) 786-1326.
Under the Paperwork Reduction Act of 1995 (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. The term “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 publish a 30-day notice in the
1.
To maximize resources, CMS will focus on assisting the industry to improve their operations to ensure beneficiaries receive access to care. One way to accomplish this is CMS will develop an annual audit strategy which describes how sponsors will be selected for audit and the areas that will be audited. CMS has developed several audit protocols and these are posted to the CMS Web site each year for use by sponsors to prepare for their audit. Currently CMS utilizes the following 7 protocols to audit sponsor performance: Formulary Administration (FA), Coverage Determinations, Appeals & Grievances (CDAG), Organization Determination, Appeals and Grievances (ODAG), Special Needs Model of Care (SNPMOC) (only administered on organizations who operate SNPs), Compliance Program Effectiveness (CPE), Medication Therapy Management (MTM) and Provider Network Accuracy (PNA). The data collected is detailed in each of these protocols and the exact fields are located in the record layouts, at the end of each protocol. In addition, questionnaires are distributed as part of our CDAG, ODAG and CPE audits. These questionnaires are also included in this package.
As part of a robust audit process, CMS also requires sponsors who have been audited and found to have deficiencies to undergo a validation audit to ensure correction. The validation audit utilizes the same audit protocols, but only tests the elements where deficiencies were found, as opposed to re-administering the entire audit. Finally, to assist in improving the audit process, CMS sends sponsors a link to a survey (Appendix D) at the end of each audit to complete in order to obtain the sponsors' feedback. The sponsor is not required to complete the survey.
2.
The FDCF is revised for the 2017 and 2018 DV collection periods by changing the scoring of six standards from a binary scale to a five-point Likert-type scale. This change is expected to improve the precision of the data validation scores by increasing overall variation in total scores among the MAOs and PDPs. The revision is not expected to alter resource requirements, since the assessment by DV contractors in scoring standards will continue to be based on the percentage of records that meet the standards.
Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS).
Notice of Award of nine single-source program expansion supplement grants under the UC Program.
ACF, ORR announces the award of nine single-source program expansion supplement grants for a total of $21,164,141 under the UC's Program.
ORR has been identifying additional capacity to provide shelter for potential increases in apprehensions of UC at the U.S. Southern Border. Planning for increased shelter capacity is a prudent step to ensure that ORR is able to meet its responsibility, by law, to provide shelter for UC referred to its care by the Department of Homeland Security (DHS).
The expansion supplement grants will support the need to increase shelter capacity to accommodate the increasing numbers of UCs being referred by DHS. All nine grantees have the infrastructure, licensing, experience, and appropriate level of trained staff to meet the service requirements and the urgent need for expansion of services. The grantees provide residential services to UC in the care and custody of ORR, as well as services to include counseling, case management, and additional support services to the family or to the UC and their sponsor when a UC is released from ORR's care and custody.
Supplemental award funds will support activities from October 1, 2015, through September 30, 2016.
Jallyn Sualog, Director, Division of Children's Services, Office of Refugee Resettlement, 330 C Street SW., Washington, DC 20201. Email:
ORR is continuously monitoring its capacity to shelter the UC referred to HHS, as well as the information received from interagency partners, to inform any future decisions or actions.
ORR has specific requirements for the provision of services. Award recipients must have the infrastructure, licensing, experience, and appropriate level of trained staff to meet those requirements. The expansion of the existing program and its services through this supplemental award is a key strategy for ORR to be prepared to meet its responsibility to provide shelter for UC referred to its care by DHS and so that the U.S. Border Patrol can continue its vital national security mission to prevent illegal migration, trafficking, and protect the borders of the United States.
(A) Section 462 of the Homeland Security Act of 2002, which in March 2003, transferred responsibility for the care and custody of Unaccompanied Alien Children from the Commissioner of the former Immigration and Naturalization Service (INS) to the Director of ORR of HHS.
(B) The Flores Settlement Agreement, Case No. CV85-4544RJK (C.D. Cal. 1996), as well as the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 (Pub. L. 110-457), which authorizes post release services under certain conditions to eligible children. All programs must comply with the Flores Settlement Agreement, Case No. CV85-4544-RJK (C.D. Cal. 1996), pertinent regulations, and ORR policies and procedures.
Administration for Children and Families, HHS.
Withdrawal: Notice.
On October 4, 2016 at 81 FR 68420, ACF published a 60 Day Notice of Proposed Information Collection entitled “Unaccompanied Children Case Summary Form.” ACF is withdrawing this notice from the
Robert Sargis, Reports Clearance Officer, Office of Planning Research and Evaluation.
National Institutes of Health, HHS.
Notice.
The National Institute of Aging (NIA), National Institute of Mental Health (NIMH), and National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH), University of Maryland at Baltimore (UMB) and their collaborators are seeking Cooperative Research and Development Agreement (CRADA) partners to collaborate in the preclinical and clinical development of ketamine metabolite (2R, 6R-HNK) for the treatment of depression and other anxiety-related disorders.
Interested candidate partners must submit a statement of interest and capability, no more than five pages long, to the NCATS point of contact before January 3, 2017 for consideration.
Information on licensing and co-development research collaborations, and copies of the U.S. patent applications listed below may be obtained by contacting: Attn: Sury Vepa, Ph.D., J.D., Senior Licensing and Patenting Manager, National Center for Advancing Translational Sciences, NIH, 9800 Medical Center Drive, Rockville, MD 20850, Phone: 301-217-9197, Fax: 301-217-5736, or email
As per the Anxiety and Depression Association of America, Major depressive disorder affects 14.8 million people in America, including children, adults, and the elderly. A number of therapies currently exist to treat depression, although they suffer drawbacks such as requiring weeks to take action. One particular therapy includes the approved drug, ketamine, which has demonstrated robust and acute antidepressant activity. However, its efficacy is bridled with significant disadvantages including its addictive potential and its dissociative activities. This is the case even when administered at low doses, which limits the potential widespread use of ketamine as an antidepressant medication.
In order to improve the treatment of depression, it is important to explore the mechanism by which ketamine exerts its antidepressant effects. That is precisely what the NIH and UMB scientists and collaborators are investigating, and have found that the metabolism of ketamine is critical to its antidepressant effects, and that the (2R,6R)-2-amino-2-(2-chlorophenyl)-6-hydroxycyclohexanone ((2R,6R)-hydroxynorketamine (HNK)) metabolite, reversed depression-like behaviors in mice without triggering anesthetic, dissociative, or addictive side effects associated with ketamine. Specifically, the researchers found that the
To expedite the research, development and commercialization of 2R,6R-hydroxynorketamine (a metabolite of ketamine), the National Institutes of Health, UMB and their collaborators are seeking one or more CRADA and/or license agreements with appropriate pharmaceutical or biotechnology companies in accordance with the regulations governing the transfer of Government-developed technology and its public sector objectives, as outlined below. The purpose of a CRADA is to find a partner to collaborate in the development and commercialization of a technology that is in early phases of clinical development. Under the CRADA, key activities related to the clinical development of 2R,6R-HNK as a therapeutic to treat a variety of mental health conditions including depressive disorders will be performed. Collaborators should have proven experience in drug development with specialized expertise within depression and/or related mental health disorders. Owing to NIH's commitment to public dissemination of data, a key criterion will be that all outcomes from the collaborative effort will be published including the outcomes of all clinical trials. Further, it is the goal of NIH, UMB and other collaborators to develop the technology to the fullest extent (as therapeutic for multiple clinical indications including, but not limited to, anxiety, suicidal ideation, anhedonia, PTSD, addiction, neuropathic pain, among others).
Respondents interested in submitting a CRADA proposal should be aware that it may be necessary for them to secure a patent license to the background-patent applications in order to commercialize products arising from a CRADA. Licensing of background technology patent rights related to this CRADA opportunity and claimed in the pending patent applications are available for either exclusive or non-exclusive licensing and licensing by NIH is subject to 35 U.S.C. 207 and 37 CFR part 404. CRADA partners are afforded an option to negotiate an exclusive license from the NIH for inventions arising from the performance of the CRADA research plan.
The full CRADA proposal should include a capability statement with a detailed description of: (1) Collaborator's Expertise with mental health disorders such as depression, (2) Collaborators' expertise in preclinical development efforts including toxicology and chemistry, manufacturing and controls (CMC), (3) Expertise in regulatory affairs, particularly at the IND filing and early stage clinical trials stages, (4) Collaborator's ability to support, directly or through contract mechanisms, and upon the successful completion of relevant milestones, the ongoing pharmacokinetics and biological studies, long term toxicity studies, process chemistry and other pre-clinical development studies needed to obtain regulatory approval of a given therapy so as to ensure a high probability of eventual successful commercialization and; (5) Collaborator's ability to provide adequate funding to support some pre-clinical studies of the project as well as clinical trials.
(1) “Use Of (2R,6R)-HNK, (S)-Dehydronorketamine and (R,S)-ketamine metabolites in the treatment of depression and neuropathic pain”; Irving W. Wainer, Ruin Moaddel, Michel Bernier, Carlos A. Zarate, Mary Tanga, Marc C. Torjman, Michael Goldberg; Assignees: National Institute of Aging (NIA), National Institute of Mental Health (NIMH), SRI International, University of Medicine and Dentistry of New Jersey (UMDNJ); U.S. Provisional Patent Application # 61/547,336; Filed: October 14, 2011; NIH Reference # E-092-2011.
(2) “Methods of using (2S,6S)-HNK and (2R,6R)-HNK to treat various depressive disorders and anxiety disorders”; Craig Thomas, Todd D. Gould, Irving W. Wainer, Carlos A. Zarate, Ruin Moaddel, Patrick Morris, Panos Zanos; Assignees: National Institute of Aging (NIA), National Institute of Mental Health (NIMH), National Center for Advancing Translational Sciences (NCATS), University of Maryland at Baltimore (UMB); U.S. Provisional Patent Application # 62/313317; Filed: March 25, 2016; NIH Reference #E-036-2016.
(3) “Crystal forms and methods of synthesis of (2R, 6R)-HNK and (2S,6S)-HNK”; Craig Thomas, Patrick Morris, Carlos A. Zarate, Ruin Moaddel, Todd D. Gould, Panos Zanos; Assignees: National Center for Advancing Translational Sciences (NCATS), National Institute of Mental Health (NIMH), National Institute of Aging (NIA), University of Maryland at Baltimore (UMB); U.S. Provisional Patent Application #62/313309; Filed: March 25, 2016; NIH Reference #E-116-2016.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
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.
National Institutes of Health, HHS.
Notice.
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health, National Heart, Lung, and Blood Institute (NHLBI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.
To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Jacqueline Wright, 6701 Rockledge Drive, MSC 7936, Bethesda, MD 20892, or call non-toll-free number (301) 435-0384, or Email your request to:
Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) 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 those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 23,289.
Notice is hereby given of a change in the meeting of the National Institute of Mental Health Special Emphasis Panel, November 2, 2016, 08:30 a.m. to November 2, 2016, 05:00 p.m., Washington Marriott Georgetown, 1221 22nd Street NW., Washington, DC 20037 which was published in the
The meeting notice is amended to change the location to the Marriott Wardman Park Washington DC Hotel, 2660 Woodley Road NW., Washington, DC 2008. The meeting is closed to the public.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Board of Scientific Counselors, NICHD.
The meeting will be open to the public as indicated below, with the attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Coast Guard, Department of Homeland Security.
Request for applications.
The Coast Guard seeks applications for membership on the National Offshore Safety Advisory Committee. The National Offshore Safety Advisory Committee advises the Secretary of the Department of Homeland Security on matters and actions concerning activities directly involved with or in support of the exploration of offshore mineral and energy resources insofar as they relate to matters within Coast Guard jurisdiction. Applicants selected for service on the National Offshore Safety Advisory Committee via this solicitation will not begin their respective terms until January 31, 2018.
Completed applications should reach the Coast Guard on or before January 3, 2017.
Applicants should send a cover letter expressing interest in an appointment to the National Offshore Safety Advisory Committee that also identifies under which membership category the applicant is applying, along with a resume detailing the applicant's experience via one of the following methods:
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Mr. Patrick Clark, Alternate Designated Federal Officer of the National Offshore Safety Advisory Committee, Commandant, (CG-OES-2)/NOSAC U.S. Coast Guard, 2703 Martin Luther King Jr. Avenue SE., STOP 7509, Washington, DC 20593-7509; email
The National Offshore Safety Advisory Committee is a federal advisory committee established in accordance with the provisions of the Federal Advisory Committee Act (Title 5 U.S.C. Appendix) to advise the Secretary of the Department of Homeland Security on matters and actions concerning activities directly involved with or in support of the exploration of offshore mineral and energy resources insofar as they relate to matters within Coast Guard jurisdiction.
The Committee normally meets twice a year: Once in April in New Orleans, Louisiana, and then in November in Houston, Texas. Each National Offshore Safety Advisory Committee member serves a term of office up to three (3) years. Members may serve a maximum of two (2) consecutive terms. All members serve at their own expense and receive no salary or reimbursement of travel expenses, or other compensation from the Federal Government.
We will consider applications for the 5 positions listed below that will be vacant on January 31, 2018:
(a) One member representing companies, organizations, enterprises or similar entities engaged in offshore drilling;
(b) One member representing companies, organizations, enterprises or similar entities engaged in the production of petroleum;
(c) One member representing companies, organizations, enterprises or similar entities engaged in the construction of offshore facilities;
(d) One member representing companies, organizations, enterprises or similar entities engaged in the support, by offshore supply vessel or other vessels, of offshore operations; and,
(e) One member representing employees of companies, organizations, enterprises or similar entities engaged in offshore operations, who should have recent practical experience on vessels or units involved in the offshore industry.
To be eligible, applicants for positions (a-e) should be employed by companies, organizations, enterprises or similar entities associated with the exploration for, and the recovery of oil, gas and other mineral resources on the U.S. Outer Continental Shelf; and have expertise, knowledge and experience regarding the technology, equipment and techniques that are used or are being developed for use in the exploration for, and the recovery of, offshore mineral resources.
The Department of Homeland Security does not discriminate in selection of Committee members on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disabilities and genetic information, age membership in an employee organization, or any other non-merit factor. The Department of Homeland Security strives to achieve a widely diverse candidate pool for all of its recruitment actions.
If you are interested in applying to become a member of the Committee, send your cover letter and resume to Mr. Patrick Clark, Alternate Designated Federal Officer of the National Offshore Safety Advisory Committee, via one of the transmittal methods in the
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of an emergency declaration for the State of Florida (FEMA-3377-EM), dated October 6, 2016, and related determinations.
Effective October 19, 2016.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
Notice is hereby given that the incident period for this emergency is closed effective October 19, 2016.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of South Carolina (FEMA-4286-DR), dated October 11, 2016, and related determinations.
Effective October 14, 2016.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of South Carolina is hereby amended to include the Individual Assistance program for the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of October 11, 2016.
Marion County for Individual Assistance (already designated for assistance for debris removal and emergency protective measures [Categories A and B], including direct federal assistance, under the Public Assistance program).
Orangeburg County for Individual Assistance.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of South Carolina (FEMA-4286-DR), dated October 11, 2016, and related determinations.
Effective October 25, 2016.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of South Carolina is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of October 11, 2016.
Berkeley County for Individual Assistance (already designated for Public Assistance).
Charleston County for Individual Assistance (already designated for assistance for debris removal and emergency protective measures [Categories A and B], including direct federal assistance, under the Public assistance program).
Chesterfield County for Individual Assistance.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the State of Wisconsin (FEMA-4288-DR), dated October 20, 2016, and related determinations.
Effective October 20, 2016.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
Notice is hereby given that, in a letter dated October 20, 2016, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
I have determined that the damage in certain areas of the State of Wisconsin resulting from severe storms, flooding, and mudslides during the period of September 21-22, 2016, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses.
You are authorized to provide Public Assistance in the designated areas and Hazard Mitigation throughout the State.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Benigno Bern Ruiz, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster.
The following areas of the State of Wisconsin have been designated as adversely affected by this major disaster:
Adams, Chippewa, Clark, Crawford, Jackson, Juneau, La Crosse, Monroe, Richland, and Vernon Counties for Public Assistance.
All areas within the State of Wisconsin are eligible for assistance under the Hazard Mitigation Grant Program.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of an emergency declaration for the State of Georgia (FEMA-3379-EM), dated October 6, 2016, and related determinations.
Effective October 15, 2016.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
Notice is hereby given that the incident period for this emergency is closed effective October 15, 2016.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Florida (FEMA-4280-DR), dated September 28, 2016, and related determinations.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Florida is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of September 28, 2016.
Columbia and Gadsden Counties for Public Assistance. Hernando County for Public Assistance (already designated for Individual Assistance).
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of South Carolina (FEMA-4286-DR), dated October 11, 2016, and related determinations.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of South Carolina is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of October 11, 2016.
Chesterfield County for Public Assistance (already designated for Individual Assistance).
Kershaw and Richland Counties for Public Assistance.
Calhoun, Charleston, Clarendon, Darlington, and Marlboro Counties for Public Assistance [Categories C-G] (already designated for Individual Assistance and assistance for debris removal and emergency protective measures [Categories A and B], including direct federal assistance, under the Public Assistance program).
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of South Carolina (FEMA-4286-DR), dated October 11, 2016, and related determinations.
Effective October 19, 2016.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of South Carolina is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of October 11, 2016.
Calhoun, Clarendon, and Marlboro Counties for Individual Assistance and assistance for debris removal and emergency protective measures (Categories A and B), including direct federal assistance, under the Public Assistance program.
Horry for Individual Assistance (already designated for Public Assistance).
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of South Carolina (FEMA-4286-DR), dated October 11, 2016, and related determinations.
Effective October 17, 2016.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of South Carolina is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of October 11, 2016.
Allendale, Bamberg, Barnwell, Hampton, Lee, and Sumter Counties for Individual Assistance and assistance for debris removal and emergency protective measures (Categories A and B), including direct federal assistance, under the Public Assistance program.
Beaufort, Colleton, Darlington, Dillon, Dorchester, Florence, Georgetown, Jasper, and Williamsburg Counties for Individual Assistance (already designated for assistance for debris removal and emergency protective measures [Categories A and B], including direct federal assistance, under the Public Assistance program).
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of South Carolina (FEMA-4286-DR), dated October 11, 2016, and related determinations.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of South Carolina is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of October 11, 2016.
Allendale, Bamberg, Barnwell, Beaufort, Colleton, Dillon, Dorchester, Florence, Georgetown, Hampton, Jasper, Lee, Marion, Sumter, and Williamsburg Counties for Public Assistance [Categories C-G] (already designated for Individual Assistance and assistance for debris removal and emergency protective measures [Categories A and B], including direct federal assistance, under the Public Assistance program).
Berkeley and Horry Counties for Public Assistance [Categories C-G] (already designated for assistance for debris removal and emergency protective measures [Categories A and B], including direct federal assistance, under the Public Assistance program).
Orangeburg County for Public Assistance (already designated for Individual Assistance).
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Office of Policy Development and Research, HUD.
Notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Anna P. Guido, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Room 4176, Washington, DC 20410-5000; telephone 202-402-5534 (this is not a toll-free number) or email at
Anna P. Guido, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Anna P. Guido at
Copies of available documents submitted to OMB may be obtained from Ms. Guido.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
CDBG-DR funds are appropriated to HUD and then allocated to affected states and local governments. At that point, the grantees will be eager to move quickly, to develop programs to provide support to individuals and organizations that need it, and to begin recovery in earnest. But launching a disaster recovery program can be an enormous challenge. Some grantees have minimal previous experience with the base CDBG program. Even the more experienced grantees struggle with the scale of the challenge—both the level of need in the community and the amount of funds suddenly available for deployment. And there are, of course, many challenges unique to disaster recovery, that grantees may never have had to deal with before. All of these factors, and more, combine to hinder the recovery of disaster-affected communities. The purpose of this project is to examine factors that contribute to delays in launching housing recovery programs in the wake of severe disasters, and to produce a guidebook that will help to accelerate that process.
Conducting this research will require the research team (The Urban Institute, under HUD grant H-21670CA) to interview a variety of individuals with experience with disaster recovery, and the CDBG-DR program in particular.
All interviews will be confidential and not attributed to individuals by name or association. Interview results will be coded for analytical purposes and used to inform the study's two key deliverables: A retrospective report on factors that contribute to rapid disaster recovery and a guidebook to help disaster-affected communities recover more quickly.
The table below estimates the total burden to the public for the proposed information collection, assuming an hourly cost per response based on the GS-15 step 1 hourly wage rate.
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) 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) The accuracy of the agency'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 those who are to respond, including the use of appropriate automated collection techniques or other forms of information technology,
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Office of the Assistant Secretary for Community Planning and Development, HUD.
Notice.
This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for possible use to assist the homeless.
Juanita Perry, Department of Housing and Urban Development, 451 Seventh Street SW., Room 7266, Washington, DC 20410; telephone (202) 402-3970; TTY number for the hearing- and speech-impaired (202) 708-2565 (these telephone numbers are not toll-free), call the toll-free Title V information line at 800-927-7588 or send an email to
In accordance with the December 12, 1988 court order in
Fish and Wildlife Service, Interior.
Notice of receipt of applications for permit.
We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications to conduct certain activities with endangered species. With some exceptions, the Endangered Species Act (ESA) prohibit activities with listed species unless Federal authorization is acquired that allows such activities.
We must receive comments or requests for documents on or before December 5, 2016.
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When submitting comments, please indicate the name of the applicant and the PRT# you are commenting on. We will post all comments on
Brenda Tapia, (703) 358-2104 (telephone); (703) 358-2281 (fax);
Send your request for copies of applications or comments and materials concerning any of the applications to the contact listed under
Please make your requests or comments as specific as possible. Please confine your comments to issues for which we seek comments in this notice, and explain the basis for your comments. Include sufficient information with your comments to allow us to authenticate any scientific or commercial data you include.
The comments and recommendations that will be most useful and likely to influence agency decisions are: (1) Those supported by quantitative information or studies; and (2) Those that include citations to, and analyses of, the applicable laws and regulations. We will not consider or include in our administrative record comments we receive after the close of the comment period (see
Comments, including names and street addresses of respondents, will be available for public review at the street address listed under
To help us carry out our conservation responsibilities for affected species, and in consideration of section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
The applicant requests a permit to import biological samples for all wildlife species, both of wild-origin and captive-held or captive-bred for the purpose of scientific research. This notification covers activities to be conducted by the applicant over a 5-year period.
The applicant requests a permit to import one live male captive-born amur leopard (
On June 3, 2016, we published a
The following applicants each request a permit to import the sport-hunted trophy of one male bontebok (
Bureau of Indian Affairs, Interior.
Notice.
The State of California and the Pala Band of Mission Indians entered into a Tribal-State compact governing Class III gaming. This notice announces that the compact is taking effect.
The effective date of the compact is November 4, 2016.
Ms. Paula L. Hart, Director, Office of Indian Gaming, Office of the Assistant Secretary—Indian Affairs, Washington, DC 20240, (202) 219-4066.
Section 11 of the Indian Gaming Regulatory Act (IGRA) requires the Secretary of the Interior to publish in the
National Park Service, Interior.
Notice of availability.
The National Park Service (NPS) announces the availability of the Draft Archeological Resources Management Plan/Environmental Impact Statement (EIS), Knife River Indian Village National Historic Site (Park), North Dakota.
All comments must be postmarked or transmitted not later than January 3, 2017.
A limited number of hard-copies of the Draft EIS may be picked up in-person or may be obtained by making a request in writing to Knife River Indian Villages National Historic Site, P.O. Box 9, Stanton, North Dakota 58571. The document is also available on the internet at the NPS Planning, Environment, and Public Comment Web site at:
Superintendent Craig Hansen can be reached at the address above, by telephone at (701) 745-3741 (ext. 209), or via email at
This process has been conducted pursuant to the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Riverbank erosion has been an ongoing problem since the Park was created and this ongoing impact has the greatest adverse effect to archeological resources. Over the past few decades village remnants and archeological sites adjacent to the Knife River have experienced measurable erosion. In addition, Northern pocket gophers affect archeological sites by displacing soil and artifacts from chronologically stratified deposits. Also, the encroachment of woody and overgrown vegetation into archeological sites causes multiple issues for archeological sites. Root growth results in displacement of chronological layers, similar to that of pocket gophers.
The maintenance facility for the Park is a visual intrusion in the cultural landscape, particularly for the Big Hidatsa site, a designated National Historic Landmark. The North Dakota State Historic Preservation Office (SHPO) and the Mandan, Hidatsa, and Arikara Nation (MHA Nation) Tribal Historic Preservation Office have recommended that the facility be relocated to remove this visual impact from the site. In addition, the maintenance facility is located near burial sites and areas considered sacred by the tribes traditionally associated with the resources present in the Park.
Finally, the location of the Museum Collection Storage Facility, in the basement of the Visitor's Center, has had water infiltration issues. A final goal of this plan is to develop a remedy for this problem, or the storage facility will need to be replaced.
Management would respond to archeological resource threats but without the benefit of site prioritization and a proactive adaptive management framework. Under the no-action alternative, existing Park infrastructure would remain in place. Repairs to the existing visitor center to address water infiltration issues would occur. Ongoing riverbank erosion, pocket gopher control, and vegetation encroachment management activities would continue.
The NPS has developed indicators and standards for managing the archeological resources based on the Park's purpose, significance, objectives, and desired conditions. These indicators and standards will serve as a tool to monitor and evaluate the adaptive management actions.
Additionally, the museum collection would be moved if the project to stop water infiltration in the visitor center building is unsuccessful or if the Park identifies funding or partnership opportunities to relocate the museum collection out of the basement of the Visitor's Center to a more suitable location.
In order to comment on this plan, comments may be transmitted electronically through the project Web site (address above). If preferred, you may mail written comments directly to the Superintendent at the address above.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
National Park Service, Interior.
Notice of availability; record of decision.
The National Park Service (NPS) has prepared and approved a Record of Decision (ROD) for the Nonfederal Oil and Gas Regulations (36 CFR part 9, subpart B) Revisions. Approval of this Record of Decision completes the National Environmental Policy Act process.
November 4, 2016.
Copies of the ROD are available for public review at
David Steensen, Chief, Geologic Resources Division, National Park Service, PO Box 25287, Denver, CO 80225; phone (303) 969-2014. The responsible official for this ROD is Jonathan Jarvis, Director, National Park Service, 1849 C Street NW., Washington, DC 20240.
This process was conducted in accordance with the requirements of the National Environmental Policy Act of 1969, as amended (NEPA) (42 U.S.C. 4321
The FEIS evaluated the environmental consequences of three alternatives, Alternative A (no action), Alternative B (preferred and environmentally preferable alternative), and Alternative C.
Alternative B includes the following alternative elements:
• Elimination of two regulatory provisions that exempt 60% of the oil and gas operations in System units. All operators in System units would be required to comply with the 9B regulations.
• Elimination of the financial assurance (bonding) cap. Financial assurance would be equal to the reasonable estimated cost of site reclamation.
• Improving enforcement authority by incorporating existing NPS penalty provisions. Law enforcement staff would have authority to write citations for noncompliance with the regulations.
• Authorizing compensation to the federal government for new access on federal lands and waters outside the boundary of an operator's mineral right.
• Reformatting the regulations to make it easier to identify an operator's information requirements and operating standards that apply to each type of operation.
Alternative C includes all the proposed changes in Alternative B, except:
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The NPS consulted with traditionally associated American Indian tribes and groups, State Historic Preservation Officers, United States Fish and Wildlife Service, United States Environmental Protection Agency, state oil and gas regulatory commissions, and the state of Alaska.
The ROD includes a summary of the purpose and need for action, synopses of alternatives considered and analyzed in detail, a description of the selected alternative, including measures that are included in the rule to minimize environmental harm, the basis for the decision, a description of the environmentally preferable alternative, and findings on impairment of park resources. The ROD is not the final agency action for those elements of the EIS that require promulgation of regulations to be effective. Promulgation of such regulations will constitute the final agency action for such elements, and will be published in a separate
Bureau of Ocean Energy Management (BOEM), Interior.
List of Restricted Joint Bidders.
Pursuant to the joint bidding provisions of 30 CFR 556.511—556.515, the Director of the Bureau of Ocean Energy Management is publishing a List of Restricted Joint Bidders. Each entity within one of the following groups is restricted from bidding with any entity in any of the other following groups at Outer Continental Shelf oil and gas lease sales to be held during the bidding period November 1, 2016, through April 30, 2017. This List of Restricted Joint Bidders will cover the period November 1, 2016, through April 30, 2017, and replace the prior list published on May 17, 2016, which covered the period of May 1, 2016, through October 31, 2016.
Bureau of Reclamation, Interior.
Notice.
The Bureau of Reclamation, along with the U.S. Army Corps of Engineers and the Bonneville Power Administration as joint lead agencies, are adding one public scoping meeting to invite the public to comment on the scope of the Columbia River System Operations Environmental Impact Statement.
The additional scoping meeting will be held on Monday, November 21, 2016, 4 p.m. to 7 p.m., in Pasco, Washington.
The meeting will be held at the Holiday Inn Express & Suites Pasco-Tri Cities, 4525 Convention Place, Pasco, Washington 99301.
Call the toll-free telephone 1-(800) 290-5033 or email
One scoping meeting is being added to the schedule. All other scoping meetings for the Columbia River System Operations Environmental Impact Statement were previously announced in a notice that was published in the
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled
Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be
General information concerning the Commission may also be obtained by accessing its Internet server at United States International Trade Commission (USITC) at
The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of DSM Desotech, Inc. and DSM IP Assets B.V. on October 31, 2016. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain UV curable coatings for optical fibers, coated optical fibers, and products containing same. The complaint names as respondents Momentive UV Coatings (Shanghai) Co., Ltd. of China; and OFS Fitel, LLC of Norcross, GA. The complainant requests that the Commission issue a limited exclusion order, cease and desist orders and impose a bond upon respondents' alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).
Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) Explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) explain how the requested remedial orders would impact United States consumers.
Written submissions must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to § 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (“Docket No. 3181”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.
30-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
Comments are encouraged and will be accepted for an additional 30 days until December 5, 2016.
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 other additional information, please contact Kenneth Mason, Firearms and Explosives Services Specialist, National Firearms Act Branch, either by mail at 244 Needy Road, Martinsburg, WV 25405, 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:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
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Drug Enforcement Administration, Department of Justice.
30-Day notice.
The Department of Justice (DOJ), Drug Enforcement Administration, 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. This collection was previously published in the
Comments are encouraged and will be accepted for an additional 30 days until December 5, 2016.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Kirsten Waters, Unit Chief, Domestic Strategic Intelligence Unit, Office of Strategic Intelligence and Programs, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152. Written comments and/or suggestions can also be directed to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20530 or sent to
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:
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Bureau of Justice Statistics, Department of Justice.
30-Day notice.
The Department of Justice (DOJ), Office of Justice Programs, Bureau of Justice Statistics, 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. This proposed information collection was previously published in the
Comments are encouraged and will be accepted for 30 days until December 5, 2016.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Tracy L. Snell, Statistician, Bureau of Justice Statistics, 810 Seventh Street NW., Washington, DC 20531 (email:
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:
Overview of this information collection:
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If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405B, Washington, DC 20530.
On October 31, 2016, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the District of Connecticut in the lawsuit entitled
In the Complaint, the United States, on behalf of the U.S. Environmental Protection Agency (EPA), and the State of Connecticut, on behalf of the Connecticut Department of Energy and Environmental Protection (CT DEEP), allege that the defendant, Eastgate Plaza, LLC, is liable under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), 42 U.S.C. 9601,
The publication of this notice opens a period for public comment on the 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:
Please enclose a check or money order for $10.75 (25 cents per page reproduction cost, including Appendices), payable to the United States Treasury.
Employment and Training Administration, Labor.
Notice.
The Secretary of Labor signed the annual certifications under the Federal Unemployment Tax Act, 26 U.S.C. 3301
In accordance with the provisions of Section 3304(c) of the Internal Revenue Code of 1986 (26 U.S.C. 3304(c)), I hereby certify the following named states to the Secretary of the Treasury for the 12-month period ending on October 31, 2016, in regard to the unemployment compensation laws of those states, which heretofore have been approved under the Federal Unemployment Tax Act:
This certification is for the maximum normal credit allowable under Section 3302(a) of the Code.
In accordance with the provisions of paragraph (1) of Section 3303(b) of the Internal Revenue Code of 1986 (26 U.S.C. 3303(b)(1)), I hereby certify the unemployment compensation laws of the following named states, which heretofore have been certified pursuant to paragraph (3) of Section 3303(b) of the Code, to the Secretary of the Treasury for the 12-month period ending on October 31, 2016:
This certification is for the maximum additional credit allowable under Section 3302(b) of the Code, subject to the limitations of Section 3302(c) of the Code.
Notice.
The Department of Labor (DOL) is submitting the Bureau of Labor Statistics (BLS) sponsored information collection request (ICR) titled, “American Time Use Survey,” to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
The OMB will consider all written comments that agency receives on or before December 5, 2016.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the
Submit comments about this request by mail or courier to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-BLS, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email:
Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at
This ICR seeks to extend PRA authority for the American Time Use Survey (ATUS)
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the current approval for this collection is scheduled to expire on December 31, 2016. The DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
44 U.S.C. 3507(a)(1)(D).
Mine Safety and Health Administration, Labor.
Request for public comments.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed collections of information in accordance with the Paperwork Reduction Act of 1995. This program helps to assure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection for Health Standards for Diesel Particulate Matter Exposure (Underground Coal Mines)
All comments must be received on or before January 3, 2017.
Comments concerning the information collection requirements of this notice may be sent by any of the methods listed below.
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Sheila McConnell, Director, Office of Standards, Regulations, and Variances, MSHA, at
Section 103(h) of the Federal Mine Safety and Health Act of 1977 (Mine Act), 30 U.S.C. 813(h), authorizes the Mine Safety and Health Administration (MSHA) to collect information necessary to carry out its duty in protecting the safety and health of miners. Further, Section 101(a) of the Mine Act, 30 U.S.C. 811 authorizes the Secretary to develop, promulgate, and revise as may be appropriate, improved mandatory health or safety standards for the protection of life and prevention of injuries in coal or other mines.
MSHA established standards and regulations for diesel-powered equipment in underground coal mines that provide additional important protection for coal miners who work on and around diesel-powered equipment. The standards were designed to reduce the risks to underground coal miners of serious health hazards that are
Section 72.510(a) requires underground coal mine operators to provide annual training to all miners who may be exposed to diesel emissions. The training must include health risks associated with exposure to diesel particulate matter; methods used in the mine to control diesel particulate concentrations; identification of the personnel responsible for maintaining those controls; and actions miners must take to ensure controls operate as intended.
Section 72.510(b) requires underground coal mine operators to keep a record of the training for one year.
Section 72.520(a) and (b) requires underground coal mine operators to maintain an inventory of diesel powered equipment units together with a list of information about any unit's emission control or filtration system. The list must be updated within 7 calendar days of any change.
MSHA is soliciting comments concerning the proposed information collection related to Health Standards for Diesel Particulate Matter Exposure (Underground Coal Mines). MSHA is particularly interested in comments that:
• Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information has practical utility;
• Evaluate the accuracy of MSHA's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
• Suggest methods to enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
The information collection request will be available on
The public may also examine publicly available documents at USDOL-Mine Safety and Health Administration, 201 12th South, Suite 4E401, Arlington, VA 22202-5452. Sign in at the receptionist's desk on the 4th floor via the East elevator.
Questions about the information collection requirements may be directed to the person listed in the
This request for collection of information contains provisions for Health Standards for Diesel Particulate Matter Exposure (Underground Coal Mines). MSHA has updated the data with respect to the number of respondents, responses, burden hours, and burden costs supporting this information collection request.
Comments submitted in response to this notice will be summarized and included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.
Legal Services Corporation.
Announcement of intention to make FY 2017 Grant Awards.
The Legal Services Corporation (LSC) hereby announces its intention to award grants to provide economical and effective delivery of high quality civil legal services to eligible low-income clients, beginning January 1, 2017.
All comments and recommendations must be received on or before the close of business on December 5, 2016.
Legal Services Corporation—Grants Awards, Legal Services Corporation; 3333 K Street NW., Third Floor, Washington, DC 20007.
Reginald Haley, Office of Program Performance, at (202) 295-1545, or
Pursuant to LSC's announcement of funding availability on March 24, 2016, 81 FR 15754, and Grant Renewal applications due beginning June 1, 2016, LSC intends to award funds to provide civil legal services in the indicated service areas. Applicants for each service area are listed below. The amounts below are estimates based on the 2016 grant awards to each service area. The estimates incorporate the adjustments for the agricultural worker population as described at
LSC will post all updates and/or changes to this notice at
These grants will be awarded under the authority conferred on LSC by section 1006(a)(1) of the Legal Services Corporation Act, 42 U.S.C. 2996e(a)(l). Awards will be made so that each service area is served, although no listed organization is guaranteed an award. Grants will become effective and grant funds will be distributed on or about January 1, 2017.
This notice is issued pursuant to 42 U.S.C. 2996f(f). Comments and recommendations concerning potential grantees are invited, and should be delivered to LSC within 30 days from the date of publication of this notice.
National Archives and Records Administration (NARA).
Notice revising Privacy Act system of records (SORN) for NARA 39.
The National Archives and Records Administration (NARA) proposes to revise its system of records on visitor services in its existing inventory of systems subject to the Privacy Act of 1974, as amended (“Privacy Act”). In this notice, NARA publishes the proposed revised NARA 39, Visitor Service System (VSS) Files (formerly Visitor Ticketing Application (VISTA) Files). NARA is revising SORN 39 to reflect a move to a cloud-hosted environment, which affects the system name, location information, and safeguards.
This revised system of records, NARA 39, will become effective December 14, 2016 without further notice unless we receive comments by
You may submit comments, identified by “SORN NARA 39,” by one of the following methods:
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Kimberly Keravuori, External Policy Program Manager, by email at
The notice for this system of records states the record system's name and location, authority for and manner of operation, categories of individuals it covers, types of records it contains, sources of information in the records, and the “routine uses” from Appendix A for which the agency may use the information. Appendix B includes the business address of the NARA official you may contact to find out how you may access and correct records pertaining to yourself. You may find Appendix A and Appendix B on NARA's Web site at
The Privacy Act provides certain safeguards for an individual against an invasion of personal privacy. It requires Federal agencies that disseminate any record of personally identifiable information to do so in a manner that assures the action is for a necessary and lawful purpose, the information is current and accurate for its intended use, and the agency provides adequate safeguards to prevent misuse of such information. NARA intends to follow these principles when transferring information to another agency or individual as a “routine use,” including assuring that the information is relevant for the purposes for which it is transferred.
Visitor Service System (VSS) Files.
The system data is in a cloud-hosted environment, located in the continental United States.
Individuals covered by this system include people who purchase tickets to Presidential libraries, serve as points of contact for groups visiting the Presidential libraries, and are invited guests to special events at the libraries.
VSS files may include the following information on an individual: Name, mailing address, telephone number, email address, and credit card information.
44 U.S.C. 2108, 2111 note, 2112, and 2203(f)(1).
NARA maintains the VSS files on individuals to: Store information on groups that interact with the library; conduct outreach with the points of contact in these groups to maintain visitor levels and improve service; study visitor data over time; communicate confirmation letters to visitors, and store information on those attending special events. Libraries may disclose the information to support their Presidential library foundations, and where a library is co-located with a National Park, to the National Park Service. The routine use statements A, C, E, F, G, and H, described in Appendix A, also apply to this system of records.
Electronic records.
Staff may retrieve information in the records by the individual's name or any of the other categories of information in the database.
Staff access the electronic records via password-protected workstations located in attended offices or through a secure, remote-access network. After business hours, buildings have security guards and/or secured doors, and electronic surveillance equipment monitors all entrances.
NARA retains and disposes of the records in accordance with the NARA Records Control Schedule and the General Records Schedules approved by the National Archives and Records Administration.
The system manager is the Director, Office of Presidential Libraries. The business address for the system manager is listed in Appendix B.
People inquiring about their records should notify the NARA Privacy Act Officer at the address listed in Appendix B.
People who wish to access their records should submit a request in writing to the NARA Privacy Act Officer at the address listed in Appendix B.
NARA's rules for contesting the contents of a person's records and appealing initial determinations are in 36 CFR part 1202.
NARA obtains information in the VSS files from visitors and from NARA employees who maintain the files.
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
November 30, 2016; 8:00 a.m. to 12:00 p.m. (EST)
Welcome/Introductions; BFA/OIRM/OLPA Updates; NSF Strategic Plan; BOAC and Operations with its Subcommittees; Update from Subcommittee on National Academy of Public Administration (NAPA); Application of Lessons Learned from Other Lessons-Learned Programs.
Results from the 2016 Federal Employees Viewpoint Survey (FEVS); Discussion with Director and Chief Operating Officer; Update: Committee on Equal Opportunities in Science and Engineering (CEOSE); Meeting Wrap-Up.
National Science Foundation.
Notice of permit modification request received and permit issued under the Antarctic Conservation Act of 1978.
The National Science Foundation (NSF) is required to publish a notice of requests to modify permits issued to conduct activities regulated and permits issued under the Antarctic Conservation Act of 1978. NSF has published regulations under the Antarctic Conservation Act at Title 45 Part 671 of the Code of Federal Regulations. This is the required notice of a requested permit modification and permit issued.
Nature McGinn, ACA Permit Officer, Division of Polar Programs, Rm. 755, National Science Foundation, 4201 Wilson Boulevard, Arlington, VA 22230. Or by email:
The Foundation issued a permit (ACA 2016-008) to David Rootes, Environmental Manager, Antarctic Logistics and Expeditions, LLC, on October 23, 2015. The issued permit allows the applicant to operate a remote camp at Union Glacier, Antarctica, and provide logistical support services for scientific and other expeditions, film crews, and tourists. These activities include aircraft support, cache positioning, camp and field support, resupply, search and rescue, medevac, medical support and logistic support for some National Operators.
Now the applicant proposes a permit modification to continue permitted activities, including minimization, mitigation, and monitoring of waste, for the 2016-2017 Antarctic season. The Environmental Officer has reviewed the modification request and has determined that the amendment is not a material change to the permit, and it will have a less than a minor or transitory impact.
The permit modification was issued on October 31, 2016.
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
December 1, 2016; 8:00 a.m.-1:00 p.m.
Operated assisted teleconference is available for this meeting. Call 888-658-9757 with password EHRAC and you will be connected to the audio portion of the meeting.
To attend the meeting in person, all visitors must contact the Directorate for Education and Human Resources (
Meeting materials and minutes will also be available on the EHR Advisory Committee Web site at
November 7, 14, 21, 28, December 5, 12, 2016.
Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.
Public and Closed.
There are no meetings scheduled for the week of November 7, 2016.
There are no meetings scheduled for the week of November 14, 2016.
There are no meetings scheduled for the week of November 21, 2016.
Tuesday, November 29, 2016
This meeting will be webcast live at the Web address—
There are no meetings scheduled for the week of December 5, 2016.
This meeting will be webcast live at the Web address—
The schedule for Commission meetings is subject to change on short notice. For more information or to verify the status of meetings, contact Glenn Ellmers at 301-415-0442 or via email at
The NRC Commission Meeting Schedule can be found on the Internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (
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On September 23, 2016, NASDAQ Stock Market LLC (“Exchange” or “NASDAQ”) filed with the Securities and Exchange Commission (“Commission”) a proposal to amend NASDAQ Rule 7014(f) to, among other things, change their Lead Market Maker Program (now renamed the “Designated Liquidity Provider (“DLP”) Program”) to include a new rebate, the New Product Support Incentive (“NPSI”).
Specifically, the Exchange will pay an NPSI rebate to a DLP of $0.0070 per executed share in the first year from the ETP's launch, on a decreasing scale until the NPSI is phased out as the ETP ages, terminating three years from the ETP's launch.
With the implementation of the NPSI, issuers of newly launched ETPs that choose to list on NASDAQ are automatically enrolled in the NPSI and would indirectly benefit from this liquidity support, which is intended to incentivize market makers to engage in more quotation and trading activity than might otherwise be undertaken in the absence of payments under the NPSI in order to help facilitate the distribution of newly launched ETPs. As such, the Commission believes that participating in the NPSI could constitute an indirect attempt by the issuer to induce a bid for or purchase of a covered security during a restricted period potentially in violation of Rule 102 of Regulation M.
The Commission has provided limited, conditional exemptions from Rule 102 for issuers to participate in a number of similar programs, such as the NASDAQ MQP, which also involved an indirect attempt by the issuer to induce a bid for or a purchase of a covered security during a restricted period.
The Commission believes that potential investors in NPSI Securities should be provided with sufficient information regarding the potential impact of the NPSI on the price and liquidity of the ETPs, particularly given the temporary and limited nature of each ETP's enrollment in the program. Accordingly, the Commission is granting a limited exemption from Rule 102 of Regulation M solely to permit issuers to participate indirectly in the NPSI Rebates, subject to certain conditions described below.
Rule 102 of Regulation M prohibits issuers, selling security holders, or any affiliated purchaser of such persons, directly or indirectly, from bidding for, purchasing, or attempting to induce any person to bid for or purchase a covered security
On the basis of the conditions set out below, which in general are designed to help inform investors about the potential impact of the NPSI to potential investors of NPSI Securities, the Commission finds that it is appropriate in the public interest, and is consistent with the protection of investors, to grant a limited exemption from Rule 102 of Regulation M solely to permit NPSI Issuers to list NPSI Securities on NASDAQ while the NPSI is in effect and thus, to participate indirectly in the payment of the NPSI Rebates to DLPs.
This limited exemption is conditioned on the NPSI Issuer, or sponsor if applicable, making specific disclosures, as set forth below. The disclosures are designed to alert potential investors that the trading market for NPSI Securities may be affected by these payments. Specifically, these disclosures are designed to inform potential investors about the potential impact of the NPSI on the natural market forces of supply and demand prior to making an investment decision in these newly launched securities products. These disclosures are expected to promote greater investor protection by helping to ensure that investors adequately informed as to this potential impact. We also note that, to the extent that information about the NPSI is material, disclosure of this kind may already be required by the federal securities laws.
(1) At the beginning of the restricted period, as defined in Rule 100 of Regulation M,
(2) Immediately after launch, or immediately at the beginning of the period in which a market maker's trading activity can qualify for an NPSI Rebate in an NPSI Security, as applicable, the following disclosure shall be continuously maintained and updated until termination of the NPSI Rebate, and shall, as necessary, be supplemented with the disclosure in (3) below: “The [Specific ETP name] is listed on NASDAQ. As such, it is enrolled in NASDAQ's New Product Support Incentives Rebate (“NPSI Rebate”), which is a payment made to certain market makers depending on how actively they quote and trade [Specific ETP]. The [Specific ETP] has participated in the NPSI Rebate since [date], and will no longer be eligible to participate in the program on [date], which is three years from the launch date (unless the program is terminated or modified before then or if [Specific ETP] becomes too liquid to participate in the NPSI before then). Certain market makers quoting and trading [Specific ETP] on NASDAQ will be eligible to receive NPSI Rebates until that date, unless, again, the program is terminated or modified before then or if [Specific ETP] becomes too liquid to participate in the NPSI before then. The payment of the NPSI Rebates is intended to help provide liquidity support for newly launched exchange-traded products by generating more quotes and trading than might otherwise exist absent these payments. Investors should be aware that when these payments cease, there may be an adverse impact on the price and liquidity of [Specific ETP], which could adversely impact a purchaser's subsequent sale of the security.”; and
(3) No less than 30 days before the expected termination date, or as soon as practicable after the NPSI Issuer becomes aware or should become aware that the NPSI Security will no longer be eligible to participate in the NPSI and before the end of such eligibility, the following disclosure shall be added to the disclosure required in (2) above: “UPDATE: [Specific ETP] is expected to no longer qualify for the NPSI rebates on [or around] [date]. This may impact the price or liquidity of [Specific ETP], which could adversely impact a
This exemptive relief shall terminate upon the event of any material change to the NPSI, including a change to the types of securities permitted to participate in the program or to the terms or amount of the payments made pursuant to the NPSI.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to list and trade shares of the following under Commentary .02 to NYSE Arca Equities Rule 8.200 (“Trust Issued Receipts”): ForceShares Daily 4X US Market Futures Long Fund and ForceShares Daily 4X US Market Futures Short Fund. The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to list and trade shares (“Shares”) of the following under Commentary .02 to NYSE Arca Equities Rule 8.200, which governs the listing and trading of Trust Issued Receipts (“TIRs”):
Each of the Funds is a commodity pool that is a series of the ForceShares Trust (“Trust”), a Delaware statutory trust. The Funds' sponsor is ForceShares LLC (the “Sponsor”). ALPS Distributors, Inc. is the marketing agent for the Funds' Shares (“Marketing Agent”). U.S. Bank National Association is the Funds' custodian (“Custodian”), which, in such capacity, holds the Funds' “Cash Equivalents” (as described below) and/or cash pursuant to a custodial agreement. The Custodian is also the registrar and transfer agent for the Funds' Shares.
The Long Fund's primary investment objective is to seek daily investment results, before fees and expenses, that correspond to approximately four times (400%) the daily performance, and the Short Fund's primary investment objective is to seek daily investment results, before fees and expenses, that correspond to approximately four times
The Sponsor employs a “neutral” investment strategy intended to track the changes in the Benchmark regardless of whether the Benchmark goes up or goes down. Each Fund's “neutral” investment strategy is designed to permit investors generally to purchase and sell a Fund's Shares with the objective of gaining leveraged exposure to Big S&P Contracts and, therefore, the S&P 500® (“S&P 500 Index”), in a cost-effective manner.
Each Fund seeks to achieve its primary investment objective under normal market conditions
Permissible Other S&P Interests are the following: Swap agreements (cleared and over-the-counter), over-the-counter forward contracts, and short positions on futures contracts, in each case with respect to and referencing Primary S&P Interests or the S&P 500 Index.
Each Fund may also acquire options on futures contracts (
Each Fund's positions in S&P Interests will be changed or “rolled” on a regular basis in order to track the changing nature of the Benchmark. For example, quarterly (on the date on which a Big S&P Contract expires), the deferred month (or next-to-expire) Big S&P Contract will become the “Lead” month (or front month) Big S&P Contract and will become the Benchmark Component Futures Contract, and each Fund's investments will have to be changed accordingly. During roll periods, the Benchmark will be composed of a combination of the lead month Big S&P Contract and/or the deferred month Big S&P Contract. The Benchmark is a “rolling index”, which means that the Benchmark does not take physical possession of any commodities. An investor with a rolling futures position is able to avoid delivering (or taking delivery of) underlying physical commodities while maintaining exposure to those commodities. The Benchmark Component Futures Contract is changed from the lead month Big S&P Contract to the deferred month Big S&P Contract over a four-day period. Each quarter, the Benchmark Component Futures Contract changes start at the end of the day on the date two weeks (twelve days) prior to expiration of the lead month Big S&P Contract for that month. During the first three days of the period, the applicable value of the Benchmark is based on a combination of the lead month Big S&P Contract and the deferred month Big S&P Contract as follows:
• On day 1, the Benchmark consists of 75% of the lead month Big S&P Contract's price plus 25% of the deferred month Big S&P Contract's price;
• On day 2, the Benchmark consists of 50% of the lead month Big S&P Contract's price plus 50% of the deferred month Big S&P Contract's price;
• On day 3, the Benchmark consists of 25% of the lead month Big S&P Contract's price plus 75% of the deferred month Big S&P Contract's price; and
• On day 4, the Benchmark is entirely composed of the prior day's deferred month Big S&P Contract, which now constitutes the lead month Big S&P
On each day during the four-day rolling period, the Sponsor anticipates it will roll S&P Interests positions by closing, or selling, a percentage of positions in S&P Interests and reinvesting the proceeds from closing those positions in new S&P Interests that reflect the change in the Benchmark. The anticipated dates that the quarterly four-day roll period will commence are posted on a Fund's Web site at
The composition of a Fund's Stop Options positions may or may not need to be changed during a roll period. The Sponsor will consider whether to sell a Stop Option position based upon that Stop Option's economic viability, which is determined by examining its strike price relative to the existing Benchmark Futures Contract value, time to expiration, market demand and any other applicable considerations. In all circumstances, including during roll period and at the end of the roll period, the Stop Option positions will provide coverage, at an aggregate strike price of approximately 75 percent for the Long Fund or 125 percent for the Short Fund, for all of the S&P Interests held by the Fund. As a result, the Sponsor will purchase new Stop Options when required to meet the referenced coverage threshold.
The S&P Interests that each Fund will principally invest in are futures contracts, which are standardized contracts traded on, or subject to the rules of, an exchange that call for the future delivery of a specified quantity and type of asset at a specified time and place or, alternatively, may call for cash settlement. Each Fund expects to invest in S&P Interests to the fullest extent possible without (a) materially exceeding the leverage necessary to implement its primary investment objective or (b) being unable to satisfy its expected current or potential margin or collateral obligations with respect to its investments in S&P Interests. Each Fund will invest in Primary S&P Interests to the extent that it is not in violation of exchange position limits on such Primary S&P Interests.
Each Fund may acquire or dispose of Stop Options (puts or calls) on S&P Interests in pursuing its secondary
Stop Options are expected to average less than approximately five percent (5%) of the Long Fund's portfolio and less than approximately five percent (5%) of the Short Fund's portfolio.
On a day-to-day basis, a Fund will invest the remainder of its assets in money market funds, depository accounts with institutions with high quality credit ratings or short-term debt instruments that have terms-to-maturity of less than 397 days and exhibit high quality credit profiles, including U.S. government securities and repurchase agreements (collectively, “Cash Equivalents”). Cash Equivalents are expected to comprise approximately seventy to eighty-five percent (70-85%) of the Long Fund's portfolio and approximately seventy to eighty-five percent (70-85%) of the Short Fund's portfolio.
The Sponsor uses a mathematical approach to investing. Using this approach, the Sponsor determines the type, quantity and mix of investment positions that each Fund should hold to achieve, on a daily basis, approximately four times (400%) the daily performance, in the case of the Long Fund, or approximately four times the inverse (−400%) of the daily performance, in the case of the Short Fund, of the Benchmark. The Sponsor does not invest the assets of the Funds in securities or financial instruments based on the Sponsor's view of the investment merit of a particular security, instrument, or company, nor does it conduct conventional investment research or analysis or forecast market movement or trends, in managing the assets of the Funds. Each Fund seeks to remain invested at all times in securities and/or financial instruments that, in combination, provide leveraged exposure to the S&P 500 Index without regard to market conditions, trends or direction.
Following determination of a Fund's respective NAV each business day, each Fund will seek to position its portfolio so that its exposure to the Benchmark is consistent with a Fund's primary investment objective. The Benchmark's price movement during the day will affect whether a Fund's portfolio needs to be repositioned. For example, if the Benchmark has risen on a given day, the NAV of the Long Fund should rise and the NAV of the Short Fund should fall. As a result, the Long Fund's exposure would need to be increased and the Short Fund's exposure would need to be decreased. Conversely, if the Benchmark has fallen on a given day, the NAV of the Long Fund should fall and the NAV of the Short Fund should rise. As a result, the Long Fund's exposure would need to be decreased and the Short Fund's exposure would need to be increased.
Because of daily rebalancing of each Fund's Portfolio and the compounding of each day's return over time, the return of each Fund for periods longer than a single day will be the result of each day's returns compounded over the period, which will very likely differ from four times (400%) the total performance, in the case of the Long Fund, or four times the inverse (−400%) of the total performance, in the case of the Short Fund, of the Benchmark over the same period. Each Fund will lose money if the level of the Benchmark is flat over time, and it is possible that the Long Fund will lose money over time even if the level of the Benchmark rises, and the Short Fund will lose money over time even if the level of the Benchmark falls, as a result of daily rebalancing of the applicable Fund, the Benchmark's volatility and the effects of compounding.
Each Fund will be rebalanced daily in order to continue to reflect exposure equal to approximately four times (400%) the daily performance, in the case of the Long Fund, or approximately four times the inverse (−400%) of the daily performance, in the case of the Short Fund, of the Benchmark.
The Sponsor believes that market arbitrage opportunities will cause each Fund's Share price on the Exchange to track a Fund's NAV per Share. The Sponsor believes that the net effect of this expected relationship and the expected relationship between each Fund's NAV per Share and the Benchmark will be that the changes in the price of a Fund's Shares on the Exchange will track approximately four times (400%) the daily performance, in the case of the Long Fund, or four times the inverse (−400%) of the daily performance, in the case of the Short Fund, of the Benchmark. This relationship may be affected by various market factors, including but not limited to, the number of Shares of a Fund outstanding and the liquidity of the underlying holdings. The Sponsor believes that the market for Primary S&P Interests is among the more liquid futures markets and does not anticipate liquidity issues relating to a Fund's underlying holdings, absent extraordinary circumstances or material changes to the marketplace for Primary S&P Interests. While the Benchmark is composed of Big S&P Contracts and is therefore a measure of the future value of the S&P 500 Index, there is nonetheless expected to be a reasonable degree of correlation between the Benchmark and the then-current value of the S&P 500 Index.
The Sponsor will invest each Fund's assets in S&P Interests, Stop Options, Cash Equivalents and/or cash. The Sponsor will deposit a portion of each Fund's net assets with the FCM or other custodians to be used to meet its current or potential margin or collateral requirements in connection with its investment in S&P Interests. Each Fund will use only Cash Equivalents and/or cash to satisfy these requirements.
The Sponsor intends for such Stop Options to be maintained with an approximate level of coverage such that the Sponsor may put or call, as applicable, the S&P Interests at a strike price of approximately 75%, in the case of the Long Fund, or 125%, in the case of the Short Fund, of the value of the applicable underlying S&P Interests as of the end of the preceding business day. To the extent that the Sponsor is unable (whether through error or limitations in the availability of the required put or call options on futures contracts) to manage the Stop Options to provide coverage for all of a Fund's S&P Interests at the intended target strike price, it is possible that the Stop Options will not prevent a Fund's NAV from going to zero.
The design of the Funds' Benchmark is such that the Benchmark Component Futures Contracts will change four times per year, and the Funds' investments must be rolled periodically to reflect the changing composition of the Benchmark. For example, when the lead month Big S&P Contract expires, such contract will no longer be the
Conversely, in the event of a futures market where near-to-expire contracts trade at a lower price than longer-to-expire contracts, a situation referred to as “contango,” then absent the impact of the overall movement in the S&P 500 Index the value of the Benchmark Component Futures Contracts would tend to decline as they approach expiration. As a result the Long Fund's total return may be lower than might otherwise be the case because it would be selling less expensive contracts and buying more expensive ones, and the Short Fund's total return may be higher than might otherwise be the case because it would be selling more expensive contracts and buying less expensive ones. The impact of backwardation and contango may lead the total return of a Fund to vary significantly from the total return of other price references, such as the S&P 500 Index. Absent the impact of rising or falling S&P 500 Index values, a prolonged period of contango could have a significant negative impact on the Long Fund's NAV and total return and a prolonged period of backwardation could have a significant negative impact on the Short Fund's NAV and total return.
Each Fund invests in S&P Interests to the fullest extent possible without exceeding the leverage necessary to implement its primary investment objective or being unable to satisfy its expected current or potential margin or collateral obligations with respect to its investments in S&P Interests. After fulfilling such margin and collateral requirements and purchasing Stop Options consistent with its secondary investment objective, each Fund invests the remainder of its proceeds from the sale of baskets in Cash Equivalents and/or holds such assets in cash (generally in interest-bearing accounts). Therefore, the focus of the Sponsor in managing each Fund is investing in S&P Interests, Stop Options, Cash Equivalents and/or cash. Each Fund earns interest income from the Cash Equivalents that it purchases and on the cash it holds through the Custodian.
In managing each Fund's assets, the Sponsor does not use a technical trading system that automatically issues buy and sell orders. Instead, each time one or more baskets are purchased or redeemed, the Sponsor will purchase or sell S&P Interests, Stop Options and Cash Equivalents as required in respect of the amount of cash received or paid upon the purchase or redemption of the basket(s).
As an example, assume that a Creation Basket is sold by the Long Fund, and that the Long Fund's closing NAV per Share is $50. In that case, the Long Fund would receive $2,500,000 in proceeds from the sale of the Creation Basket ($50 NAV per Share multiplied by 50,000 Shares, and ignoring the Creation Basket fee in the amount set forth in the applicable Fund's prospectus). If one were to assume further that the Sponsor wants to invest the entire proceeds from the Creation Basket in Big S&P Contracts to obtain an aggregate value of $10,000,000 (
The specific S&P Interests purchased depend on various factors, including a judgment by the Sponsor as to the appropriate diversification of each Fund's investments. While the Sponsor anticipates that each Fund will seek to achieve its primary investment objective by investing in Primary S&P Interests, for various reasons, including the ability to enter into the precise amount of exposure to the S&P 500 Index and position limits on Primary S&P Interests, it may also invest in Other S&P Interests, including swaps, in the over-the-counter market to a potentially significant degree. Each Fund will be limited in investing up to twenty percent (20%) of its net assets in Other S&P Interests that may constitute securities for purposes of the Investment Company Act of 1940.
The Sponsor does not anticipate letting its Primary S&P Interests expire and taking delivery of or having to deliver cash. Instead, the Sponsor closes out existing positions,
Because the Long Fund seeks to track the Benchmark directly and profit when the value of the S&P 500 Index increases and, as a likely result of an increase in the value of the S&P 500 Index, the price of Primary S&P Interests increases, the Long Fund will generally be long on the S&P 500 Index, and will generally sell Primary S&P Interests only to close out existing long positions. Because the Short Fund seeks to track the Benchmark inversely and profit when the value of the S&P 500 Index decreases and, as a likely result of a decrease in the value of the S&P 500 Index, the price of Primary S&P Interests decreases, the Short Fund will generally be short on the S&P 500 Index, and will generally buy Primary S&P Interests only to close out existing short positions.
In addition to futures contracts, options on futures contracts and cleared swaps, derivative contracts that are tied to various securities will be entered into outside of public exchanges. The over-the-counter contracts that the Funds may enter into will take the form of either swaps or forward contracts, in each case providing exposure to the S&P 500 Index or to Big S&P Contracts.
To reduce the credit risk that arises in connection with over-the-counter contracts, each Fund generally will enter into an agreement with each counterparty based on the Master Agreement published by the International Swaps and Derivatives Association, Inc. that provides for the
The creditworthiness of each potential counterparty will be assessed by the Sponsor. The Sponsor assesses or reviews, as appropriate, the creditworthiness of each potential or existing counterparty to an over-the-counter contract pursuant to guidelines approved by the Sponsor. The creditworthiness of existing counterparties will be reviewed periodically by the Sponsor. There is no guarantee that the Sponsor's creditworthiness analysis will be successful and that counterparties selected for Fund transactions will not default on their contractual obligations.
Each Fund's NAV will be calculated by taking the current market value of a Fund's total assets and subtracting any liabilities and dividing the balance by the number of a Fund's Shares. Under each Fund's current operational procedures, each Fund's administrator, USBancorp Fund Services, LLC (the “Administrator”), will calculate the NAV of a Fund as of the earlier of 4:00 p.m. Eastern time (“E.T.”) or the close of the Exchange each day. The NAV for a particular trading day will be released after 4:15 p.m. E.T. The NAV for the Funds will be calculated by the Administrator once a day and will be disseminated daily to all market participants at the same time.
Each Fund's NAV includes, in part, any unrealized profits or losses on open swap agreements, futures or forward contracts. Under normal circumstances, a Fund's NAV will reflect the quoted closing settlement price of open futures contracts on the date when a Fund's NAV is being calculated. In instances when the quoted settlement price of futures contract traded on an exchange may not be reflective of fair value based on market condition, generally due to the operation of daily limits or other rules of the exchange or otherwise, a Fund's NAV may not reflect the fair value of open futures contracts on such date.
The Sponsor will recalculate each Fund's NAV where necessary to reflect the “fair value” of a futures contract when the futures contract closes at its price fluctuation limit for the day.
In determining the value of Primary S&P Interests, the Administrator will use the then current value of Big S&P Contracts and E-Minis (as reflected on the CME), and, at end of day, the closing settlement price of each such contract on the CME, except that the “fair value” of a Primary S&P Interest (as described in more detail below) may be used when Primary S&P Interests close at their price fluctuation limit for the day. The Administrator will determine the value of each Fund's other investments as of the earlier of the close of the Exchange or 4:00 p.m. E.T., in accordance with the current Services Agreement between the Administrator and the Trust. The value of over-the-counter S&P Interests is determined based on the value of the security, futures contract or index underlying such S&P Interest, except that a fair value may be determined if the Sponsor believes that a Fund is subject to significant credit risk relating to the counterparty to such S&P Interest. Cash Equivalents held by a Fund will be valued by the Administrator using values received from recognized third-party vendors (such as Reuters) and dealer quotes. NAV includes any unrealized profit or loss on open S&P Interests and any other credit or debit accruing to each Fund but unpaid or not received by a Fund. The fair value of a S&P Interest shall be determined by the Sponsor in good faith and in a manner that assesses the S&P Interest's value based on a consideration of all available facts and all available information on the valuation date.
Cash Equivalents will normally be valued on the basis of quotes obtained from brokers and dealers or pricing services. Exchange-traded options on futures will generally be valued at the settlement price determined by the applicable exchange.
With respect to specific derivatives:
• A total return swap on an index will be valued at the publicly available index price. The index price, in turn, is determined by the applicable index calculation agent, which generally values the securities underlying the index at the last reported sale price.
• Equity total return swaps will generally be valued using the actual underlying equity at local market closing.
• Over-the-counter [sic] will generally be valued on a basis of quotes obtained from a quotation reporting system, established market makers, or pricing services.
• Forwards will generally be valued in the same manner as the underlying securities. Forward settling positions for which market quotes are readily available will generally be valued at market value.
When a Primary S&P Interest has closed at its price fluctuation limit, the fair value determination attempts to estimate the price at which such Primary S&P Interest would be trading in the absence of the price fluctuation limit (either above such limit when an upward limit has been reached or below such limit when a downward limit has been reached). Typically, this estimate will be made primarily by reference to the price of comparable S&P Interests trading in the over-the-counter market. The fair value of an S&P Interest may not reflect such security's market value or the amount that a Fund might reasonably expect to receive for the S&P Interest upon its current sale.
In addition, in order to provide updated information relating to a Fund for use by investors and market professionals, the Exchange will calculate and disseminate throughout the trading day an updated “indicative fund value” (“IFV”). The IFV will be calculated by using the prior day's closing NAV per Share of a Fund as a base and updating that value throughout the trading day to reflect changes in the value of the underlying holdings. Tracking the changes in underlying holdings will be calculated as follows:
Benchmark Component Futures Contracts will be valued using their most recent quoted price during the trading day, for as long as the main pricing mechanism of the CME is open.
Primary S&P Interests will be valued using their most recent quoted price during the trading day for as long as the main pricing mechanism of the CME is open.
• Futures may be valued intraday using the relevant futures exchange data, or another proxy as determined to be appropriate by the third party market data provider. Benchmark Component Futures Contracts will be valued intraday using the main pricing mechanism of the CME or through another proxy if such data is not readily available.
• Total return swaps may be valued intraday using the underlying asset or index price, or another proxy as determined to be appropriate by the third party market data provider.
• Exchange-listed options may be valued intraday using the relevant exchange data, or another proxy as determined to be appropriate by the third party market data provider.
• Over-the-counter options may be valued intraday through option
• A third party market data provider's valuation of forwards will be similar to their valuation of the underlying interests, or another proxy as determined to be appropriate by the third party market data provider. The third party market data provider will generally use market quotes if available. Where market quotes are not available, they may fair value securities against proxies (such as swap or yield curves). Each Fund's disclosure of forward positions will include information that market participants can use to value these positions intraday.
Changes in the value of Cash Equivalents will not be included in the calculation of the IFV. For this and other reasons, the IFV disseminated during Exchange trading hours should not be viewed as an actual real time update of the NAV of a Fund. NAV will be calculated only once at the end of each trading day.
The IFV will be disseminated on a per Share basis every 15 seconds during the Exchange's Core Trading Session. The trading hours for the CME can be found at
The Exchange will disseminate the IFV through the facilities of Consolidated Tape Association (“CTA”) high speed line. In addition, IFV will be published on the Exchange's Web site and will be available through on-line information services such as Bloomberg and Reuters.
Each Fund will create and redeem Shares from time to time, but only in one or more “Creation Baskets” or “Redemption Baskets” comprised of 25,000 Shares. The size of Creation Baskets and Redemption Baskets is subject to change. The creation and redemption of baskets will only be made in exchange for delivery to a Fund or the distribution by a Fund of cash in an amount equal to the combined NAV of the number of Shares of the Fund included in the baskets being created or redeemed determined as of 4:00 p.m. E.T. on the day the order to create or redeem baskets is properly received. “Authorized Purchasers” are the only persons that may place orders to create and redeem baskets. Authorized Purchasers must be (1) either registered broker-dealers or other securities market participants, such as banks and other financial institutions, that are not required to register as broker-dealers to engage in securities transactions, and (2) Depository Trust Company (“DTC”) Participants. To become an Authorized Purchaser, a person must enter into an Authorized Purchaser Agreement with the Funds.
The amount of the purchase payment for a Creation Basket of a Fund will be equal to the aggregate NAV per Share of the Shares in the Creation Basket. The amount of the redemption proceeds for a Redemption Basket will be equal to the aggregate NAV per Share of the Shares in the Redemption Basket. The purchase price for Creation Baskets and the redemption price for Redemption Baskets of a Fund will be based on the actual NAV per Share calculated at the end of the business day when a request for a purchase or redemption is received by the applicable Fund.
On any business day, an Authorized Purchaser may place an order with the transfer agent to create one or more baskets. For purposes of processing purchase and redemption orders, a “business day” means any day other than a day when any of the Exchange or the CME is closed for regular trading. Purchase orders must be placed by 3:00 p.m. E.T. or the close of the Exchange Core Trading Session (normally, 4:00 p.m. E.T.) whichever is earlier.
The total payment required to create each Creation Basket is an amount in cash equal to the combined NAV of the number of Shares of a Fund included in the baskets being created determined as of 4:00 p.m. E.T. on the day the order to create baskets is properly received plus the applicable transaction fee.
The Sponsor acting by itself or through the Marketing Agent or Custodian may reject a purchase order if: (1) It determines that, due to position limits or otherwise (including, without limitation, lock limits or price fluctuation limits that may restrict the availability of S&P Interests), investment alternatives that will enable a Fund to meet its primary investment objective are not available or practicable at that time; (2) the acceptance of the purchase order would, in the opinion of counsel to the Sponsor, be unlawful; or (3) circumstances outside the control of the Sponsor, Marketing Agent or Custodian make it, for all practical purposes, not feasible to process creations of baskets.
The procedures by which an Authorized Purchaser can redeem one or more Redemption Baskets mirror the procedures for the creation of baskets. On any business day, an Authorized Purchaser may place an order with the transfer agent to redeem one or more baskets. Redemption orders must be placed by 3:00 p.m. E.T. or the close of the Exchange's Core Trading Session, whichever is earlier. By placing a redemption order, an Authorized Purchaser agrees to deliver the baskets to be redeemed through DTC's book-entry system to a Fund by the end of a later business day, generally, but not to exceed, three business days after the effective date of the redemption order, as agreed to between the Authorized Purchaser and the transfer agent when the redemption order is placed (the “Redemption Settlement Date”). Prior to the delivery of the redemption distribution for a redemption order, the Authorized Purchaser must also have wired to the Sponsor's account at the Custodian the non-refundable transaction fee due for the redemption order. An Authorized Purchaser may not withdraw a redemption order without the prior consent of the Sponsor in its discretion.
The redemption distribution from a Fund will consist of a transfer to the redeeming Authorized Purchaser of an amount in cash equal to the combined NAV of the number of Shares of a Fund included in the baskets being redeemed determined as of 4:00 p.m. E.T. on the day the order to redeem baskets is properly received, less the applicable transaction fee.
The redemption distribution due from a Fund will be paid to the Authorized Purchaser on the Redemption Settlement Date if a Fund's DTC account has been credited with the baskets to be redeemed. If a Fund's DTC account has not been credited with all of the baskets to be redeemed by the end of such date, the redemption distribution will be paid to the extent of whole baskets received.
The Sponsor may, in its discretion, suspend the right of redemption, or postpone the redemption settlement date with respect to a Fund, (1) for any period during which the Exchange or CME is closed other than customary weekend or holiday closings, or trading on the Exchange or CME is suspended or restricted, (2) for such other period as the Sponsor determines to be necessary for the protection of a Fund's
Each Fund's total portfolio composition will be disclosed each business day that the Exchange is open for trading on the Funds' Web site at
The Funds' Web site also includes the NAV, the 4 p.m. Bid/Ask Midpoint as reported by the Exchange, the last trade price for each Fund's Shares as reported by the Exchange, the Shares of each Fund outstanding, the Shares of each Fund available for issuance, and the Shares of each Fund created or redeemed on that day. The prospectus, monthly “Statements of Account,” “Quarterly Performance of the Midpoint versus the NAV” (as required by the CFTC), and the “Roll Dates” (
The Funds' Web site will contain the following information: (a) The current NAV per Share daily and the prior business day's NAV and the reported closing price; (b) the midpoint of the bid-ask price in relation to the NAV as of the time the NAV is calculated (the “Bid-Ask Price”); (c) calculation of the premium or discount of such price against such NAV; (d) the bid-ask price of Shares determined using the highest bid and lowest offer as of the time of calculation of the NAV; (e) data in chart form displaying the frequency distribution of discounts and premiums of the Bid-Ask Price against the NAV, within appropriate ranges for each of the four (4) previous calendar quarters; (f) the prospectus; and (g) other applicable quantitative information. The Funds will also disseminate the Funds' holdings on a daily basis on the Funds' Web site.
Intra-day and closing price information from brokers and dealers or independent pricing services will be available for S&P Interests, Stop Options, and Cash Equivalents.
The Exchange also will disseminate on a daily basis via the CTA information with respect to recent NAV, and Shares outstanding. The Exchange will also make available on its Web site daily trading volume of each of the Shares, closing prices of such Shares, and the corresponding NAV. The closing settlement prices of Primary S&P Interests are readily available from the CME, automated quotation systems, published or other public sources, or on-line information services such as Bloomberg or Reuters. Prices of Stop Options will be available on the markets on which they trade, automated quotation systems, published or other public sources, or on-line information services (or, for over the counter Stop Options, if any, by reference to available data for similar exchange traded Stop Options). The Benchmark will be disseminated by one or more major market data vendors every 15 seconds during the NYSE Arca Core Trading Session of 9:30 a.m. to 4:00 p.m. E.T. Quotation and last-sale information regarding each Fund's Shares will be disseminated through the facilities of the CTA. In addition, the Funds' Web site will display the intraday and closing Benchmark level, the IFV and NAV of each Fund's Shares.
The Funds will meet the initial and continued listing requirements applicable to TIRs in NYSE Arca Equities Rule 8.200 and Commentary .02 thereto. With respect to application of Rule 10A-3
The Exchange deems the Shares to be equity securities, thus rendering trading in the Shares subject to the Exchange's existing rules governing the trading of equity securities. Shares will trade on the NYSE Arca Marketplace from 4:00 a.m. to 8:00 p.m. E.T. The Exchange has appropriate rules to facilitate transactions in the Shares during all trading sessions. As provided in NYSE Arca Equities Rule 7.6, the minimum price variation (“MPV”) for quoting and entry of orders in equity securities traded on the NYSE Arca Marketplace is $0.01, with the exception of securities that are priced less than $1.00 for which the MPV for order entry is $0.0001.
The trading of the Shares will be subject to NYSE Arca Equities Rule 8.200, Commentary .02(e), which sets forth certain restrictions on ETP Holders acting as registered Market Makers in TIRs to facilitate surveillance.
With respect to trading halts, the Exchange may consider all relevant factors in exercising its discretion to halt or suspend trading in the Shares. Trading may be halted because of market conditions or for reasons that, in the view of the Exchange, make trading in the Shares inadvisable. These may include: (1) The extent to which trading is not occurring in the underlying futures contracts, or (2) whether other unusual conditions or circumstances detrimental to the maintenance of a fair and orderly market are present. In addition, trading in Shares will be subject to trading halts caused by extraordinary market volatility pursuant to the Exchange's “circuit breaker” rule
The Exchange represents that the Exchange may halt trading during the day in which an interruption to the dissemination of the IFV or the value of the underlying futures contracts occurs. If the interruption to the dissemination of the IFV or the value of the underlying
The Exchange represents that trading in the Shares will be subject to the existing trading surveillances administered by the Exchange, as well as cross-market surveillances administered by the Financial Industry Regulatory Authority (“FINRA”) on behalf of the Exchange, which are designed to detect violations of Exchange rules and applicable federal securities laws.
The surveillances referred to above generally focus on detecting securities trading outside their normal patterns, which could be indicative of manipulative or other violative activity. When such situations are detected, surveillance analysis follows and investigations are opened, where appropriate, to review the behavior of all relevant parties for all relevant trading violations.
The Exchange or FINRA, on behalf of the Exchange, or both, will communicate as needed regarding trading in the Shares, Primary S&P Interests and options on futures with other markets and other entities that are members of the Intermarket Surveillance Group (“ISG”), and the Exchange or FINRA, on behalf of the Exchange, or both, may obtain trading information regarding trading such securities and financial instruments from such markets and other entities. In addition, the Exchange may obtain information regarding trading in such securities and financial instruments from markets and other entities that are members of ISG or with which the Exchange has in place a comprehensive surveillance sharing agreement.
Not more than 10% of the net assets of a Fund in the aggregate invested in futures contracts or exchange-traded options contracts shall consist of futures contracts or exchange-traded options contracts whose principal market is not a member of ISG or is a market with which the Exchange does not have a comprehensive surveillance sharing agreement.
All statements and representations made in this filing regarding (a) the description of the portfolios, (b) limitations on portfolio holdings or reference assets, or (c) the applicability of Exchange rules and surveillance procedures shall constitute continued listing requirements for listing the Shares of a Fund on the Exchange.
The issuer has represented to the Exchange that it will advise the Exchange of any failure by a Fund to comply with the continued listing requirements, and, pursuant to its obligations under Section 19(g)(1) of the Act, the Exchange will monitor for compliance with the continued listing requirements. If a Fund is not in compliance with the applicable listing requirements, the Exchange will commence delisting procedures under NYSE Arca Equities Rule 5.5(m).
In addition, the Exchange also has a general policy prohibiting the distribution of material, non-public information by its employees.
Prior to the commencement of trading, the Exchange will inform its ETP Holders in an Information Bulletin of the special characteristics and risks associated with trading the Shares. Specifically, the Information Bulletin will discuss the following: (1) The risks involved in trading the Shares during the Opening and Late Trading Sessions when an updated IFV will not be calculated or publicly disseminated; (2) the procedures for purchases and redemptions of Shares in Creation Baskets and Redemption Baskets (and that Shares are not individually redeemable); (3) NYSE Arca Equities Rule 9.2(a), which imposes a duty of due diligence on its ETP Holders to learn the essential facts relating to every customer prior to trading the Shares; (4) how information regarding the IFV is disseminated; (5) that a static IFV will be disseminated, between the close of trading on the applicable futures exchange and the close of the NYSE Arca Core Trading Session; (6) the requirement that ETP Holders deliver a prospectus to investors purchasing newly issued Shares prior to or concurrently with the confirmation of a transaction; and (7) trading information.
In addition, the Information Bulletin will advise ETP Holders, prior to the commencement of trading, of the prospectus delivery requirements applicable to the Funds. The Exchange notes that investors purchasing Shares directly from each Fund will receive a prospectus. ETP Holders purchasing Shares from each Fund for resale to investors will deliver a prospectus to such investors. The Information Bulletin will also discuss any exemptive, no-action and interpretive relief granted by the Commission from any rules under the Act.
In addition, the Information Bulletin will reference that the Funds are subject to various fees and expenses. The Information Bulletin will also reference that the CFTC has regulatory jurisdiction over the trading of futures contracts traded on U.S. markets.
The Information Bulletin will also disclose the trading hours of the Shares of each Fund and that the NAV for the Shares will be calculated as of the earlier of 4:00 p.m. E.T. or the close of the Exchange each day. The NAV for a particular trading day will be released after 4:15 p.m. E.T. The Bulletin will disclose that information about the Shares of each Fund is publicly available on the Funds' Web site.
The basis under the Act for this proposed rule change is the requirement under Section 6(b)(5)
The Exchange believes that the proposed rule change is designed to prevent fraudulent and manipulative acts and practices in that the Shares will be listed and traded on the Exchange pursuant to the initial and continued listing criteria in NYSE Arca Equities Rule 8.200 and Commentary .02 thereto. The Exchange has in place surveillance procedures that are adequate to properly monitor trading in the Shares in all trading sessions and to deter and detect violations of Exchange rules and applicable federal securities laws. Not more than 10% of the net assets of a Fund in the aggregate invested in
The closing price and settlement prices of the Primary S&P Interests are readily available from the CME. In addition, such prices are available from automated quotation systems, published or other public sources, or on-line information services. The Benchmark will be disseminated by one or more major market data vendors every 15 seconds during the NYSE Arca Core Trading Session of 9:30 a.m. to 4:00 p.m. E.T. Quotation and last-sale information regarding the Shares will be disseminated through the facilities of the CTA. The IFV will be disseminated on a per Share basis by one or more major market data vendors every 15 seconds during the NYSE Arca Core Trading Session. The Exchange may halt trading during the day in which an interruption to the dissemination of the IFV or the value of the underlying futures contracts occurs. If the interruption to the dissemination of the IFV or the value of the underlying futures contracts persists past the trading day in which it occurred, the Exchange will halt trading no later than the beginning of the trading day following the interruption. In addition, if the Exchange becomes aware that the NAV with respect to the Shares is not disseminated to all market participants at the same time, it will halt trading in the Shares until such time as the NAV is available to all market participants.
The proposed rule change is designed to promote just and equitable principles of trade and to protect investors and the public interest in that a large amount of information will be publicly available regarding the Funds and the Shares, thereby promoting market transparency. Quotation and last sale information for the futures contracts are widely disseminated through a variety of major market data vendors worldwide. Complete real-time data for such contracts is available by subscription from Reuters and Bloomberg. The CME also provides delayed futures information on current and past trading sessions and market news free of charge on their Web sites. The Benchmark will be disseminated by one or more major market data vendors every 15 seconds during the NYSE Arca Core Trading Session of 9:30 a.m. to 4:00 p.m. E.T. The NAV per Share will be calculated daily and made available to all market participants at the same time. NYSE Arca will calculate and disseminate every 15 seconds throughout the NYSE Arca Core Trading Session an updated IFV.
The proposed rule change is designed to perfect the mechanism of a free and open market and, in general, to protect investors and the public interest in that it will facilitate the listing and trading of additional types of exchange-traded products that principally exposed to futures contracts and that will enhance competition among market participants, to the benefit of investors and the marketplace. As noted above, the Exchange has in place surveillance procedures relating to trading in the Shares and may obtain information via ISG from other exchanges that are members of ISG or with which the Exchange has in place a comprehensive surveillance sharing agreement.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Act. The Exchange notes that the proposed rule change will facilitate the listing and trading of additional types of actively-managed exchange-traded products that will enhance competition among market participants, to the benefit of investors and the marketplace.
No written comments were solicited or received with respect to the proposed rule change.
Within 45 days of the date of publication of this notice in the
(A) by order approve or disapprove the proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an 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 August 29, 2016, ICE Clear Credit LLC (“ICC”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act (“Act”)
The purpose of the proposed rule change is to adopt rules that will provide the basis for ICC to clear additional credit default swap contracts.
ICC has proposed amending Subchapter 26D of its Rules to provide for the clearance of additional EM Contracts, specifically the Republic of Panama, Abu Dhabi, Dubai, the State of Israel and the State of Qatar. ICC plans to offer these additional EM Contracts on the 2003 and 2014 ISDA Credit Derivatives Definitions.
ICC represents that these additional EM Contracts have terms consistent with the other EM Contracts approved for clearing at ICC and governed by Subchapter 26D of the Rules. Minor revisions to Subchapter 26D (Standard Emerging Market Sovereign (“SES”) Single Name) will also be made to provide for clearing the additional EM Contracts. Specifically, in Rule 26D-102 (Definitions), “Eligible SES Reference Entities” will be modified to include the Republic of Panama, Abu Dhabi, Dubai, the State of Israel and the State of Qatar in the list of specific Eligible SES Reference Entities to be cleared by ICC.
Additionally, ICC has proposed amending Subchapter 26I of its Rules to provide for the clearance of 2003 ISDA Definitions of SWES Contracts. ICC currently clears the 2014 ISDA Definitions of ten SWES Contracts, namely the Republic of Ireland, the Italian Republic, the Portuguese Republic, the Kingdom of Spain, the Kingdom of Belgium, the Republic of Austria, the Kingdom of the Netherlands, the Federal Republic of Germany, the French Republic and the United Kingdom of Great Britain and Northern Ireland. The proposed changes to Subchapter 26I will allow ICC to offer clearing for the 2003 ISDA Definitions of these SWES Contracts.
Minor revisions to Subchapter 26I (Standard Western European (“SWES”) Single Name) will be made to provide for clearing the 2003 ISDA Definitions of SWES Contracts. Specifically, in Rule 26I-102 (Definitions), the definitions of “Eligible SWES Reference Obligations”, “List of Eligible SWES Reference Entities” and “SWES Contract Reference Obligations” will be updated to distinguish between the 2003- and 2014-Type CDS Contracts, and the corresponding Applicable Credit Derivatives Definitions.
Rule 26I-315 (Terms of the Cleared SWES Contract) will be revised to provide reference to provisions of the proper ISDA Definitions, and corresponding changes to provision numbering will be made as necessary. Rule 26I-315(h) will be revised to refer to the Applicable Credit Derivatives Definitions and eligible Seniority Level, as appropriate.
Defined terms in Rule 26I-316 (Physical Settlement Matrix Updates) will be updated to refer specifically to SWES contracts. Rule 26I-616 (Contract Modification) will be revised to note that it shall not constitute a Contract Modification if the Board (or its designee) updates the List of Eligible SWES Reference Entities (and modifies the terms and conditions of related SWES Contracts) to give effect to determinations of Succession Events.
Finally, ICC has proposed amending Subchapter 26L of its rules to provide for the clearance of an additional Asia/Pacific Contract, namely the Kingdom of Thailand. ICC plans to offer this contract on the 2003 and 2014 ISDA Credit Derivatives Definitions.
ICC represents that the additional Asia/Pacific Contract has terms consistent with the other Asia/Pacific Contracts approved for clearing at ICC and governed by Subchapter 26L of the Rules. Minor revisions to Subchapter 26L (Asia/Pacific Sovereign (“SAS”) Single Name) will be made to provide for clearing the additional Asia/Pacific Contract. Specifically, in Rule 26L-102 (Definitions), “Eligible SAS Reference Entities” will be modified to include the Kingdom of Thailand in the list of specific Eligible SAS Reference Entities to be cleared by ICC.
Section 19(b)(2)(C) of the Act
ICC has represented that the additional EM Contracts, Asia/Pacific
On the basis of the foregoing, the Commission finds that the proposal is consistent with the requirements of the Act
It is therefore ordered, 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 the provisions of Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange is filing a proposal to amend the MIAX Options Fee Schedule (the “Fee Schedule”). While changes to the Fee Schedule pursuant to this proposal are effective upon filing, the Exchange has designated these changes to be operative on October 17, 2016.
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend the MIAX Options Fee Schedule (the “Fee Schedule”) to offer two (2) additional Limited Service MIAX Express Interface (“MEI”) Ports to Market Makers.
Currently, MIAX assesses monthly MEI Port Fees on Market Makers based upon the number of MIAX matching engines
The Exchange originally added the Limited Service MEI Ports to enhance the MEI Port connectivity made available to Market Makers, and has subsequently made additional Limited Service MEI Ports available to Market
The purpose of this amendment to the Fee Schedule is to accommodate the Exchange's introduction of complex orders and quotes, as well as to provide Market Makers with access to additional functionality to be introduced in the future thereby continuing to offer Market Makers greater and improved technical flexibility to connect additional Limited Service MEI Ports to independent servers that host their eQuote and purge functionality. The Exchange believes that the offering of additional ports will help Market Makers mitigate the risk of using the same server for all of their Market Maker simple and complex quoting. By using the additional Limited Service MEI Ports for risk purposes, Market Makers can place purge functionality on a different server than the Market Maker quoting server (via the Limited Service MEI Ports), which provides them a failsafe for getting out of the market in case they have an issue with the quote server. Market Makers can also use the extra Limited Service MEI Ports to submit eQuotes. Since eQuotes are frequently generated by a different algorithm that determines when to respond to an auction message, the Exchange believes that the offering of additional ports will further enable Market Makers to connect to a different server that processes auctions and eQuotes rather than forcing them to use their Market Maker Standard quote server as a gateway for communicating eQuotes to MIAX.
The Exchange believes that its proposal to amend its Fee Schedule is consistent with Section 6(b) of the Act
The Exchange believes that its proposal is consistent with Section 6(b)(4) of the Act because only Market Makers that decide that they need the extra Limited Service MEI Ports will be charged the additional fee. The Exchange further believes that the availability of the additional Limited Service MEI Ports is equitable and not unfairly discriminatory because it further enhances Market Makers' access to the MIAX System and consequently enhances the marketplace by helping Market Makers to better manage risk, thus preserving the integrity of the MIAX markets, all to the benefit of and protection of investors and the public as a whole.
The Exchange also believes that its proposal is consistent with the objectives of Section 6(b)(5) of the Act
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange believes that the proposal increases both intermarket and intramarket competition by enabling Market Makers to enhance their connectivity to the Exchange in a manner that is designed to provide Market Makers of different sizes and business models to be assessed a MEI Port fee and to have technical connectivity that best matches their quoting activity on the Exchange and the offering of additional Limited Service MEI Ports comports with this objective. The Exchange believes that the proposal will increase competition amongst Market Makers of different sizes and business models by encouraging Market Makers to connect additional Limited Service Ports to independent servers that host their eQuote and purge functionality. The Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive. In such an environment, the Exchange must continually adjust its fees to remain competitive with other exchanges and in order to attract market participants to use its services. The Exchange believes that the proposal reflects this competitive environment because it increases the Exchange's fees in a manner that continues to encourage market participants to register as Market Makers on the Exchange, to provide liquidity, and to attract order flow. To the extent that this purpose is achieved, all the Exchange's market participants should benefit from the improved market liquidity.
Written comments were neither solicited nor received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act,
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to 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.
U.S. Small Business Administration.
Amendment 9.
This is an amendment of the Presidential declaration of a major disaster for the State of North Carolina (FEMA-4285-DR), dated 10/10/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
The notice of the Presidential disaster declaration for the State of North Carolina, dated 10/10/2016 is hereby amended to include the following areas as adversely affected by the disaster:
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of South Carolina (FEMA-4286-DR), dated 10/18/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of South Carolina, dated 10/18/2016, is hereby amended to include the following areas as adversely affected by the disaster.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Florida (FEMA-4283-DR), dated 10/24/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of Florida, dated 10/24/2016, is hereby amended to establish the incident period for this disaster as beginning 10/03/2016 and continuing through 10/19/2016.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Amendment 2.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Florida (FEMA-4283-DR), dated 10/24/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of Florida, dated 10/24/2016, is hereby amended to include the following areas as adversely affected by the disaster.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Amendment 3.
This is an amendment of the Presidential declaration of a major disaster for the State of Florida (FEMA-4283-DR), dated 10/17/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
The notice of the President's major disaster declaration for the State of Florida, dated 10/17/2016 is hereby amended to establish the incident period for this disaster as beginning 10/03/2016 and continuing through 10/19/2016.
All other information in the original declaration remains unchanged.
In accordance with the Code of Federal Regulations 13—Business Credit and Assistance § 123.512, the following interest rate is effective for Military Reservist Economic Injury Disaster Loans approved on or after October 26, 2016.
U.S. Small Business Administration.
Amendment 4.
This is an amendment of the Presidential declaration of a major disaster for the State of Florida (FEMA-4283-DR), dated 10/17/2016.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
The notice of the Presidential disaster declaration for the State of Florida, dated 10/17/2016 is hereby amended to include the
All other information in the original declaration remains unchanged.
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 30 days for public comment preceding submission of the collection to OMB.
The Department will accept comments from the public up to
Direct comments to the Department of State Desk Officer in the Office of Information and Regulatory Affairs (OIRA) at the Office of Management and Budget (OMB). You may submit comments by the following methods:
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You must include the DS form number, information collection title, and OMB control number in any correspondence.
Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, to Steve Derscheid—Management Analyst, who may be reached at
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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.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
The International Traffic in Arms Regulations (ITAR) §§ 122.4 and 129.8 require registrants to notify the Directorate of Defense Trade Controls of the Department of State in the event of a change in registration information, in the event a foreign person or entity acquires a registered entity, or if the registrant is a party to a merger, acquisition, or divestiture (MAD) of an entity producing or marketing ITAR-controlled items. Based on certain conditions enunciated in the ITAR, respondents must notify DDTC of these changes at differing intervals—no less than 60 days prior to the event and/or within 5 days of its culmination. This information is necessary for DDTC to ensure registration records are accurate and to determine whether the transaction is in compliance with the regulations (
On June 20, 2016, DDTC published a
One commenter remarked that the proposed 2-hour burden for the DS-7789 is low and should be revised. DDTC replies that the burden is an average of all submissions using the DS-7789, and while some responses will require a longer period based on the complexity of a transaction, many will be far below the declared burden for the form. Similarly, information previously provided to the Directorate via the DS-2032, Statement of Registration, will auto-populate into the DS-7789, saving respondents the burden of re-keying their basic information multiple times. DDTC therefore believes that a 2-hour burden is accurate for this form.
Another comment centered on the name of the form itself, “Statement of Material Change, Merger, Acquisition, or Divestiture of a Registered Party.” The commenter was concerned that the term “material change” is inconsistent with current business usage and the use of this form could potentially affect the market value of the submitting company. While DDTC understands these concerns, the changes that require notification, and are therefore “material changes” for ITAR purposes, are defined in the regulations (see ITAR § 122.4).
Multiple commenters opined that the form, currently formatted in four separate sheets, is difficult to follow. DDTC notes that the form as currently written serves as a “placeholder” for a new case management system that is in development, and the focus throughout the form's creation has been to finalize discrete data fields and workflows more than format. The data fields on the form will be used to guide users through questions based on their previous responses; not all users will see all fields during each submission.
Relatedly, many commenters noted that Block 1 of the form, currently named “Applicant Information,” should be changed to “Registrant Information” to avoid confusing nomenclature. DDTC notes that the title of this block is a field designator only, as the word “Applicant” will be used throughout the case management system to collate data fields for interoperability. The title of the field has no bearing on the role of the submitter of the DS-7789 and is not intended to imply that the submitter is “applying” to declare a material change. Rather, this was done in order for the electronic system to recognize the information in this block as duplicative of information that might be contained elsewhere in the user's system profile.
DDTC believes that many of the usability issues identified by the commenters will be resolved through the guided nature of the case management system. For instance, some comments noted that the .pdf version of the DS-7789 lacked functionality to add additional supporting documentation and that text fields did not expand to accommodate easier editing. DDTC notes that the case management system will have fully functional “add” capability as well as unlimited-character text boxes which will allow for easy editing of responses. To this point, some commenters also noted that uploading information on each authorization (licenses and agreements) that will transfer ownership through a merger, acquisition, or divestiture (“MAD”) event is unduly burdensome and that respondents should have the ability to upload documentation in lieu of keying such information into the system. DDTC replies that the case management system will automatically populate this field from the registrant's information; users will then have the ability to select which authorizations will transfer under the proposed merger, acquisition, or divestiture instead of keying information on each authorization.
One commenter noted that DDTC has historically provided a limited period for an acquired entity's registration to remain current after the date of the transaction to allow for the shipment of unshipped balances on authorizations which are transferring to the new or acquiring entity, but that this practice is not reflected on the DS-7789. DDTC replies that this practice stemmed from paper-based reporting and was used to allow companies to continue exporting goods under approved licenses while the authorizations were manually updated within DDTC. Because of the automated nature of the DS-7789, authorizations will be transferred rapidly from one entity to another and therefore the “grace period” will no longer be needed nor provided in the ordinary course.
Several commenters also opined that DDTC should convene an industry working group to beta test the new form and system that is being developed. In fact, DDTC has already convened such a group, and all interested industry users are welcome to join by contacting
Many respondents provided feedback on the instructions for the DS-7789. Most comments centered on requesting more detailed guidance for specific fields on the form. DDTC is pleased to provide additional guidance and revised instructions will be made available on the DDTC Web site (
DDTC also received several comments related to the electronic signature requirement for the DS-7789. Numerous responses noted that the signature requirement for a senior officer is unduly burdensome for their executive-level managers; DDTC notes that the requirement for a senior officer to sign a notification of a change in registration information is enunciated in ITAR § 122.4. Similarly, one commenter opined that the requirement to provide information about senior officers and board members on the 60-day submission preceding a MAD event should be dispensed with since they may not be the same once the event actually occurs; however, DDTC needs this information to evaluate the entirety of a transaction, and it will still be required.
Many commenters also remarked that the “60-day Buyer” portion of the form should be removed as only registered parties are required to submit information to DDTC. DDTC notes that the requested information is
Two comments also centered on the protection of information submitted via the form's proposed electronic interface. DDTC's IT security team is working on a secure web-based system to accept proprietary data from industry users. Recognizing the sensitivity of the data submitted, the system will meet all current government standards for data security and the Privacy Act of 1974. Similarly, DDTC will protect information from public disclosure to the extent permitted by law. DDTC encourages submitters to clearly mark proprietary information in accordance with the Department of State guidelines at 22 CFR 171.12.
This information will be collected by DDTC's electronic case management system and respondents will certify the data via electronic signature. Respondents will be required to enroll in DDTC's online system and will be issued an appropriate credential based on the business the user will be transacting. Lower assurance matters (such as initial registration in the system) will require a secure username
The Department of State will conduct an open meeting at 9:00 a.m. on November 9, 2016, in Room 5L18-01 of the Douglas A. Munro Coast Guard Headquarters Building at St. Elizabeth's, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593. The primary purpose of the meeting is to prepare for the one hundred and seventeenth session of the International Maritime Organization's (IMO) Council to be held at the IMO Headquarters, United Kingdom, December 5-9, 2016.
The agenda items to be considered include:
Members of the public may attend this meeting up to the seating capacity of the room. To facilitate the building security process, and to request reasonable accommodation, those who plan to attend should contact the meeting coordinator, LCDR Tiffany Duffy, by email at
Please note that due to security considerations, two valid, government issued photo identifications must be presented to gain entrance to Coast Guard Headquarters. It is recommended that attendees arrive to Coast Guard Headquarters no later than 30 minutes ahead of the scheduled meeting for the security screening process. Coast Guard Headquarters is accessible by taxi and public transportation. Parking in the vicinity of the building is extremely limited. Additional information regarding this and other IMO public meetings may be found at:
Surface Transportation Board.
Notice tentatively approving and authorizing finance transaction.
On October 7, 2016, National Express LLC (National Express or Applicant), a noncarrier, filed an application under 49 U.S.C. 14303 to acquire control of Trinity, Inc. (Trinity), Trinity Cars, Inc. (Trinity Cars), and Trinity Student Delivery, LLC (Trinity Student) (collectively, Acquisition Carriers). The Board is tentatively approving and authorizing the transaction, and, if no opposing comments are timely filed, this notice will be the final Board action. Persons wishing to oppose the application must follow the rules at 49 CFR 1182.5 & 1182.8.
Comments must be filed by December 19, 2016. Applicant may file a reply by January 3, 2017. If no opposing comments are filed by December 19, 2016, this notice shall be effective on December 20, 2016.
Send an original and 10 copies of any comments referring to Docket No. MCF 21073 to: Surface Transportation Board, 395 E Street SW., Washington, DC 20423-0001. In addition, send one copy of comments to Applicant's representative: Andrew K. Light, Scopelitis, Garvin, Light, Hanson & Feary, P.C., 10 W. Market Street, Suite 1500, Indianapolis, IN 46204.
Jonathon Binet (202) 245-0368. Federal Information Relay Service (FIRS) for the hearing impaired: 1-800-877-8339.
Applicant, a noncarrier, states that it is a holding company organized under the laws of the state of Delaware that is indirectly controlled by a British corporation, National Express Group, PLC (Express Group). Applicant states that Express Group indirectly controls the following passenger motor carriers (collectively, National Express Affiliated Carriers): Beck Bus Transportation Corp. (Beck); Carrier Management Corporation (CMI); Diamond Transportation Services, Inc. (Diamond); Durham School Services, L.P. (Durham); MV Student Transportation, Inc. (MV); National Express Transit Corporation (NETC); National Express Transit Services Corporation (NETSC); Petermann Ltd. (LTD); Petermann Northeast LLC (Northeast); Petermann Northwest LLC (Northwest); Petermann Southwest LLC (Southwest); Petermann STSA, LLC (STSA); The Provider Enterprises, Inc. (Provider); Rainbow Management Service Inc. (Rainbow); Robertson Transit, Inc. (Robertson); Safeway Training and Transportation Services Inc. (Safeway); Septran, Inc. (Septran); Smith Bus Service, Inc. (Smith); Suburban Paratransit Service, Inc. (Suburban Paratransit); Trans Express,
Applicant asserts the following facts regarding the National Express Affiliated Carriers held by Express Group:
• Beck is a passenger motor carrier primarily engaged in providing student school bus transportation services in the states of Illinois and Indiana under contracts with regional and local school jurisdictions. Beck also provides charter passenger services to the public. It holds interstate common carrier authority from Federal Motor Carrier Safety Administration under MC-143528.
• CMI is a passenger motor carrier doing business as Matthews Bus Company and is primarily engaged in providing student school bus transportation services in the state of Pennsylvania under contracts with regional and local school jurisdictions. CMI also provides intrastate charter passenger services to the public. CMI does not have interstate carrier authority as it is not required for the operations conducted by CMI.
• Diamond is a passenger motor carrier providing exempt interstate and regulated intrastate paratransit and shuttle services in the District of Columbia metropolitan area. It does not have interstate carrier authority.
• Durham is a passenger motor carrier primarily engaged in providing student school bus transportation services in approximately 32 states under contracts with regional and local school jurisdictions. Durham also provides charter passenger services to the public. It holds interstate common carrier authority under MC-163066.
• MV is a passenger motor carrier primarily engaged in providing student school bus transportation services in the state of Missouri under contracts with regional and local school jurisdictions. MV also provides charter passenger services to the public. It holds interstate common carrier authority under MC-148934.
• NETC is an intrastate passenger motor carrier with its principal place of business in Cincinnati, Ohio. NETC does not have interstate carrier authority.
• NETSC is a passenger motor carrier engaged primarily in providing intrastate transit services in the areas of Westmoreland, PA; Arlington, VA; Greensboro, NC; Vallejo, CA; and Yuma, AZ. NETSC does not have interstate carrier authority as it is not required for the operations conducted by NETSC.
• LTD is a passenger motor carrier primarily engaged in providing non-regulated school bus transportation services in the state of Ohio under contracts with regional and local school jurisdictions. LTD also provides charter passenger services to the public. It holds interstate common carrier authority under MC-364668.
• Northeast is a passenger motor carrier primarily engaged in providing student school bus transportation services, primarily in the states of Ohio and Pennsylvania under contracts with regional and local school jurisdictions. Northeast also provides charter passenger services to the public. It holds interstate contract carrier authority under MC-723926.
• Northwest is a passenger motor carrier primarily engaged in providing non-regulated school bus transportation services under contracts with regional and local school jurisdictions. Northwest does not have interstate carrier authority as it is not required for the operations conducted by Northwest.
• Southwest is a passenger motor carrier primarily engaged in providing student school bus transportation services in the state of Texas under contracts with regional and local school jurisdictions. Southwest also provides charter passenger services to the public. It holds interstate contract carrier authority under MC-644996.
• STSA is a passenger motor carrier primarily engaged in providing student school bus transportation services, primarily in the state of Kansas under contracts with regional and local school jurisdictions. STSA also provides charter passenger services to the public. It holds interstate contract carrier authority under MC-749360.
• Provider is a passenger motor carrier doing business as Provider Bus, and is primarily engaged in providing non-regulated school bus transportation services in the state of New Hampshire under contracts with regional and local school jurisdictions. Provider does not have interstate carrier authority as it is not required for the operations conducted by Provider.
• Rainbow provides interstate and intrastate charter and special party passenger transportation services in the state of New York. It holds interstate passenger common carrier authority under MC-490015.
• Robertson is a passenger motor carrier primarily engaged in providing non-regulated school bus transportation services in the state of New Hampshire under contracts with regional and local school jurisdictions. Robertson also provides charter passenger service to the public. It does not have active interstate carrier authority, though MC-176053 is assigned to it.
• Safeway is a passenger motor carrier primarily engaged in providing non-regulated school bus transportation services in the state of New Hampshire under contracts with regional and local school jurisdictions. It does not have active interstate carrier authority, though MC-522039 is assigned to it.
• Septran is a passenger motor carrier primarily engaged in providing non-regulated school bus transportation services in the state of Illinois under contracts with regional and local school jurisdictions. It does not have active interstate carrier authority, though MC-795208 is assigned to it.
• Smith is a passenger motor carrier primarily engaged in providing non-regulated school bus transportation services in the state of Maryland and surrounding areas under contracts with regional and local school jurisdictions. Smith does not have interstate carrier authority as it is not required for the operations conducted by Smith.
• Suburban Paratransit is a motor carrier providing paratransit services primarily in Westchester County and Bronx, N.Y. Suburban Paratransit does not have interstate carrier authority as it is not required for the operations conducted by Suburban Paratransit.
• Trans Express provides interstate and intrastate passenger transportation services in the state of New York. It holds interstate passenger common carrier authority under MC-187819.
• White Plains is a passenger motor carrier doing business as Suburban Charters, and it operates primarily as a provider of non-regulated school bus transportation services in the state of New York. White Plains also operates as a motor passenger carrier providing charter service to the public. It holds interstate passenger common carrier authority under MC-160624.
Applicant asserts the following facts with regard to the Acquisition Carriers:
• Trinity is a Michigan corporation operating primarily as a provider of non-regulated school bus transportation services in southeastern Michigan, and also operates as a passenger motor carrier providing charter service to the public. Trinity holds common carrier operating authority under MC-364003.
• Trinity Cars is also a Michigan corporation, operating as an intrastate passenger motor carrier as a provider of for-hire sedan and van service in southeastern Michigan. Trinity Cars holds interstate operating authority under MC-632139.
• Trinity Student is a Michigan limited liability company and a wholly-owned subsidiary of Trinity. Trinity Student operates primarily as a provider of non-regulated school bus transportation services in the areas of Toledo and Cleveland, Ohio. Trinity
Applicant states that all of the issued and outstanding stock of Trinity and Trinity Cars is owned and held by Jerry Sheppard, Jr., Trustee of the Jerry Sheppard, Jr. Revocable Inter-Vivos Trust U/A/D Sept. 24, 2003, as amended (Jerry Sheppard Trust), and Rebetha J. Sheppard, Trustee of the Rebetha J. Sheppard Revocable Inter-Vivos Trust U/A/D Sept. 24, 2003, as amended (Rebetha Sheppard Trust) (collectively, Sellers).
Applicant asserts that there is one affiliate of the Acquisition Carriers, Trinity Coach, LLC, though it is not a part of the contemplated transaction. Applicant states that Trinity Coach, LLC, is a Michigan limited liability company that is a passenger motor carrier providing interstate services under common carrier authority under MC-537169. Jerry Sheppard, Jr., individually, holds a 100% membership interest in Trinity Coach, LLC.
Applicant further states that, other than the National Express Affiliated Carriers, the Acquisition Carriers, and Trinity Coach, there are no other affiliated carriers with regulated interstate operations, and the Sellers have no other direct or indirect ownership interest in any other interstate passenger motor carrier.
Applicant also asserts that it would acquire direct 100% control of Trinity and Trinity Cars through stock ownership, and indirect control of Trinity Student as a wholly-owned subsidiary of Trinity.
Under 49 U.S.C. 14303(b), the Board must approve and authorize a transaction that it finds consistent with the public interest, taking into consideration at least: (1) The effect of the proposed transaction on the adequacy of transportation to the public; (2) the total fixed charges that result; and (3) the interest of affected carrier employees. Applicant submitted information, as required by 49 CFR 1182.2, including information to demonstrate that the proposed transaction is consistent with the public interest under 49 U.S.C. 14303(b), and a statement that the aggregate gross operating revenues of the National Express Affiliated Carriers and the Acquisition Carriers exceeded $2 million for the preceding 12-month period.
Applicant submits that the proposed transaction would have no significant impact on the adequacy of transportation services to the public, as the Acquisition Carriers would continue to provide the services they currently provide using the same names for the foreseeable future. Applicant states that the Acquisition Carriers “will continue to operate, but going forward, will be operating within the National Express corporate family.” (Appl. 14.)
According to Applicant, “[t]he addition of the Acquisition Carriers to the carriers held by National Express is consistent with the practices within the passenger motor carrier industry of strong, well-managed transportation organizations adapting their corporate structure to operate several different passenger carriers within the same market, but in different geographic areas.” (
Applicant also claims that neither competition nor the public interest would be adversely affected by the contemplated transaction. Applicant states that the Acquisition Carriers are “relatively small carriers in the overall markets in which they compete: Unregulated metropolitan school bus operations, providers of charter services, and providers of sedan and van services.” (
Applicant asserts that there are no fixed charges associated with the contemplated transaction. Applicant also states that it does not anticipate a measurable reduction in force or changes in compensation levels and/or benefits to employees. Applicant submits, however, that staffing redundancies could potentially result in limited downsizing of back-office or managerial level personnel.
The Board finds that the acquisition proposed in the application is consistent with the public interest and should be tentatively approved and authorized. If any opposing comments are timely filed, these findings will be deemed vacated, and, unless a final decision can be made on the record as developed, a procedural schedule will be adopted to reconsider the application.
This action is categorically excluded from environmental review under 49 CFR 1105.6(c).
Board decisions and notices are available on our Web site at “
1. The proposed transaction is approved and authorized, subject to the filing of opposing comments.
2. If opposing comments are timely filed, the findings made in this notice will be deemed vacated.
3. This notice will be effective December 20, 2016, unless opposing comments are filed by December 19, 2016.
4. A copy of this notice will be served on: (1) The U.S. Department of Transportation, Federal Motor Carrier Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590; (2) the U.S. Department of Justice, Antitrust Division, 10th Street & Pennsylvania Avenue NW., Washington, DC 20530;
By the Board, Chairman Elliott, Vice Chairman Miller, and Commissioner Begeman.
Federal Aviation Administration (FAA), DOT.
Notice of withdrawal.
FAA is rescinding the draft FAA Order 5500.1B, Passenger Facility Charge published on August 5, 2016, and withdrawing its request for public review and comment.
The FAA previously extended the comment period to October 31, 2016. FAA subsequently established a public Docket FAA 2016-9346 and comments received will be entered into the public Docket.
Joe Hebert, Manager, Financial Analysis and Passenger Facility Charge Branch, APP-510, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591, telephone (202) 267-8375; facsimile (202) 267-5302.
On August 5, 2016, the FAA published a notice and request for comments titled “Passenger Facility Charge (PFC) Program; Draft FAA Order 5500.1B” (81 FR 51963). The notice requested interested parties submit written comments by September 30, 2016. On September 21, 2016, the FAA extended the original comment period by 31 days, from September 30, 2016, to October 31, 2016.
After careful consideration, the FAA has decided to rescind the draft Order and cancel the public review process. The FAA will issue a revised draft in the near future for public review and comment.
Federal Aviation Administration (FAA), DOT.
Notice of cancellation of preparation of environmental impact statement.
The Federal Aviation Administration (FAA) announces that it has discontinued preparation of an Environmental Impact Statement (EIS) for the proposed construction of new Runway 5R/23L and associated development at Norfolk International Airport, Norfolk, Virginia. The FAA's discontinued preparation of the EIS is based upon the completion of the first phase of the EIS. Based on the results of the first phase (Scoping and Purpose & Need development), the FAA has determined that the fundamental purpose and need is not supported by the current or anticipated development needs of the Airport at this time.
Marcus Brundage, Environmental Protection Specialist, Federal Aviation Administration, Washington Airports District Office, 23723 Air Freight Lane, Suite 210, Dulles, Virginia 20166; Telephone (703) 661-1365.
On June 12, 2015, the FAA, published in the
The stated purpose of the project was to “meet relevant FAA airfield safety standards and enhance airfield safety without reducing runway availability.” The proposed project included the decommissioning and demolition of Runway 14/32, the construction of new Runway 5R/23L and associated development at the airport, and improvement of roadway access to the airport by realigning Robin Hood Road. Other associated infrastructure was proposed for construction or demolition or relocation including taxiways, lighting, hangers, maintenance facilities, runway safety areas and runway protection zones.
In 2001, the FAA began preparing an EIS for similar projects based on the need to accommodate additional operations at the airport. During the first EIS process, the needs of the airport changed and it was determined that the projects were no longer justified based on the stated need and the preparation of the first EIS was cancelled. In 2013, the FAA agreed to proceed with a phased second EIS preparation to review a similar project proposed by the Norfolk Airport Authority. The first phase of the project consisted of consultant selection, EIS scoping, and an analysis of the proposed project's purpose and need to determine if the FAA should continue to the second phase, which would be completion of the EIS and determination.
At the conclusion of the first phase of the second EIS, the FAA determined that the fundamental purpose and need of the projects were not supported by the current or anticipated needs of the airport. The FAA is now terminating the second EIS process. However, the FAA recognizes the importance of ORF to the greater Norfolk/Hampton Roads region and to the Commonwealth of Virginia. Moreover, the FAA agrees that a parallel runway may still be a viable long-term plan for the future, if and when operational demand warrants. Therefore, the FAA continues to support the proposed runway remaining on the approved Airport Layout Plan, as conditionally approved pending environmental review on October 5, 2011, and protecting the associated airspace.
Federal Transit Administration, DOT.
Notice of proposed Buy America waiver and request for comment.
The Federal Transit Administration (FTA) received a request from the North County Transit District (NCTD) in California for a Buy America non-availability waiver for the procurement of specified replacement parts for Diesel Multiple Unit (DMU) rail vehicles. The 12 DMU rail vehicles were manufactured by Siemens as a part of their Desiro series and were placed in revenue service in 2008. Mid-life maintenance and replacement overhauls of vehicle parts are now required in order to ensure safe and continuous transit service. In accordance with 49 U.S.C. 5323(j)(3)(A), FTA is providing notice of the waiver request and seeks public comment before deciding whether to grant the request.
Comments must be received by November 14, 2016. Late-filed comments will be considered to the extent practicable.
Please submit your comments by one of the following means, identifying your submissions by docket number FTA-2016-0036:
1.
2.
3.
4.
Cecelia Comito, Assistant Chief Counsel, at (202) 366-2217 or
The purpose of this notice is to provide notice and seek comment on whether the FTA should grant a non-availability waiver for NCTD's purchase of replacement parts on their Siemens-manufactured Desiro series DMU rail vehicles, including, but not limited to, Power Pack Assembly, Power Truck Assembly, Jakobs Truck Assembly, Transmission, Primary Suspension, Secondary Suspension, Power Wheelset Assembly, Power Truck Brake Rotors, Jakobs Truck Brake Rotors, Power Truck Wheels, Jakobs Truck Wheels, A/C Compressors, and Carbody Brake Components, Automatic Train Couplers, and HVAC Roof Mounted Units (the “Replacement Parts”). The Replacement Parts are necessary for mid-life maintenance of the DMU rail vehicles.
With certain exceptions, FTA's Buy America requirements prevent FTA from obligating an amount that may be appropriated to carry out its program for a project unless “the steel, iron, and manufactured goods used in the project are produced in the United States.” 49 U.S.C. 5323(j)(1). A manufactured product is considered produced in the United States if: (1) All of the manufacturing processes for the product take place in the United States; and (2) all of the components of the product are of U.S. origin. A component is considered of U.S. origin if it is manufactured in the United States, regardless of the origin of its subcomponents. 49 CFR 661.5(d). If, however, FTA determines that “the steel, iron, and goods produced in the United States are not produced in a sufficient and reasonably available amount or are not of a satisfactory quality,” then FTA may issue a waiver (non-availability waiver). 49 U.S.C. 5323(j)(2)(B); 49 CFR 661.7(c).
NCTD provides transit service to the entire North San Diego County, serving more than 12 million riders annually. In 2003, NCTD requested and received from FTA a non-availability Buy America waiver for the procurement of 12 DMU vehicles for use on NCTD's Sprinter line, with 15 light rail stations between the cities of Escondido and Oceanside. NCTD purchased the 12 DMU vehicles in 2004 and placed the vehicles into revenue service in 2008 on NCTD's Sprinter line. The useful life of the vehicles is 25 years.
According to NCTD, the Replacements Parts for the DMU vehicles are nearing the end of their useful service lives and showing signs of wear and fatigue. Without periodic capital equipment replacement and/or rebuild, the likelihood of mechanical downtime increases significantly, equating to prolonged service outages for riders. In March 2013, NCTD removed the Sprinter service from revenue service for more than two months due to premature wear of one of the three braking systems and unavailability of domestic replacement parts. NCTD intends to replace the components over several phases during the coming years, from 2018 through 2026. The last phase is anticipated to be procured over a subsequent seven-year period. Any non-availability waiver granted would be effective for all phases of these projects and will expire upon completion of these projects.
As a part of its search for domestic Replacement Parts, NCTD issued a Request for Information (RFI) on November 12, 2013 to maintenance and engineering communities to determine if any firms existed that could either supply Buy America compliant parts and components, or reverse engineer the parts and components utilizing plans and specifications provided. More than 300 vendors received the RFI; 19 downloaded the RFI. One vendor responded that “with proper specifications, drawings, and samples, we may be able to design and supply Buy America Compliant, OE equivalent, air bellows, primary suspension, and passenger bellows.” However, the original equipment manufacturer (“OEM”) would not provide the requested proprietary information. NCTD undertook three additional procurements for the Replacement Parts. Three responses were received; none could certify to Buy America compliance. Under 49 CFR 661.7(c)(1), “It will be presumed that the conditions exist to grant this non-availability waiver if no responsive and responsible bid is received offering an item produced in the United States.”
NCTD's 12 vehicles are the only Siemens Sprinter vehicles in the United States. Additionally, since these vehicles were specifically designed to meet California Public Utilities Commission rail safety requirements, Sprinter is the only vehicle of its kind internationally. NCTD's multiple procurement efforts have demonstrated that there are no suppliers willing to invest in infrastructure to manufacture parts that are suitable only for NCTD's 12 vehicles.
Finally, under 49 U.S.C. 5323(j)(6), FTA cannot deny an application for a waiver based on non-availability unless FTA can certify that (i) the steel, iron, or manufactured good (the “item”) is produced in the United States in a sufficient and reasonably available amount; and (ii) the item produced in the United States is of a satisfactory quality. Additionally, FTA must provide a list of known manufacturers in the United States from which the item can be obtained. FTA is not aware of any manufacturers who produce the Replacement Parts in the United States.
The 12 DMUs purchased by NCTD were granted a waiver from Buy America. NCTD's efforts to identify domestic manufacturers for the various Replacement Parts were unsuccessful. FTA proposes to grant NCTD a non-availability waiver of the Buy America requirements for the Replacement Parts for the 12 DMUs which will be acquired for the replacement of the components over several phases from 2018 through 2026. Any non-availability waiver granted would be effective for all phases of these projects and will include Replacement Parts acquired to maintain the DMUs for their 25-year useful life.
The purpose of this notice is to publish NCTD's request and seek public comment from all interested parties in accordance with 49 U.S.C. 5323(j)(3)(A). Comments will help FTA understand completely the facts surrounding the request, including the effects of a potential waiver and the merits of the request. After consideration of the comments, FTA will publish a second notice in the
Federal Transit Administration, DOT.
Notice of Proposed Buy America waiver and request for comment.
The Federal Transit Administration (FTA) received a request from the Port Authority of New York and New Jersey (PANYNJ) for a Buy America public interest waiver for the procurement of equipment to replace what was damaged at the World Trade Center Transportation Hub (WTC Hub) project during Hurricane Sandy. PANYNJ seeks a public interest Buy America waiver for the replacement of equipment previously purchased for the WTC Hub. Hurricane Sandy damaged an existing construction site that receives federal funds but is not subject to FTA's Buy America requirements and the only option PANYNJ had to implement Sandy recovery work was to replace the damaged equipment with the same equipment previously acquired for the project. 49 U.S.C. 5323(j)(2)(A) and 49 CFR 661.7(b). In accordance with 49 U.S.C. 5323(j)(3)(A), FTA is providing notice of the public interest waiver request and seeks public comment before deciding whether to grant the request. If granted, the waiver would only apply to replacement of equipment damaged by Hurricane Sandy at the WTC Hub project and would not apply to any other PANYNJ resiliency projects for which FTA has provided funding.
Comments must be received by November 14, 2016. Late-filed comments will be considered to the extent practicable.
Please submit your comments by one of the following means, identifying your submissions by docket number FTA-2016-0035.
1.
2.
3.
4.
Cecelia Comito, FTA Assistant Chief Counsel, (202) 366-2217 or
The purpose of this notice is to provide notice and seek public comment on whether the FTA should grant a public interest waiver to the Port Authority of New York and New Jersey (PANYNJ) for the procurement of replacement equipment damaged by Hurricane Sandy at the World Trade Center Transportation Hub (WTC Hub) project.
With certain exceptions, FTA's Buy America requirements prevent FTA from obligating an amount that may be appropriated to carry out its program for a project unless “the steel, iron, and manufactured goods used in the project are produced in the United States.” 49 U.S.C. 5323(j)(1). If, however, FTA finds that the application of this requirement would be inconsistent with the public interest, it may waive this requirement. 49 U.S.C. 5323(j)(2)(A). In determining whether the conditions exist to grant a public interest waiver, FTA will consider all appropriate factors on a case-by-case basis, unless a general exception is specifically set out in this part. 49 U.S.C. 5323(j)(2)(A); 49 CFR 661.7(b).
On May 13, 2015, PANYNJ requested a Buy America waiver for the replacement or repair of equipment damaged by Hurricane Sandy at the WTC Hub because the WTC Hub project is being constructed pursuant to a grant awarded in 2003, it is not feasible to replace the damaged equipment with equipment that is different than that used in the original project and it is in the public's interest to repair the damage at the WTC Hub as quickly as possible. 49 U.S.C. 5323(j)(2)(A); 49 CFR 661.7(b). Additionally, the underlying project is not subject to FTA's Buy America requirements.
The September 11, 2001 terrorist attacks on the World Trade Center resulted in extensive damage to the WTC Hub. In August 2002, the Federal Emergency Management Agency (FEMA) entered into a memorandum of agreement with the U.S. Department of Transportation under which FEMA agreed to provide $2.75 billion to cover
In October 2012, the WTC Hub project was an active construction site, with an estimated project completion date of December 2015. Hurricane Sandy caused extensive damage to the construction site, resulting in more than $214 million in damage to the construction site. FTA awarded PANYNJ two grants—NY-44-X005 for $54.24 million and NY-44-X014 for $159.72 million—in Hurricane Sandy recovery funds to be used for recovery and emergency repair work for the WTC Hub project. Because the repair work was for an ongoing construction project, PANYNJ was required to use existing contracts that were originally procured in accordance with the requirements for the FEMA-funded WTC Hub project. To apply FTA's Buy America requirements to replace or repair equipment installed on an ongoing construction project would result in significant delay to completion of the project, impact contracts awarded under the FEMA funds, and potentially impact previously provided warranties. Moreover, if granted, the public interest waiver would maintain overall consistency of administration, oversight and implementation of both the ongoing WTC Hub project and the WTC Hurricane Sandy recovery work.
Accordingly, because the original project was funded by FEMA and therefore, not subject to FTA's Buy America regulations, FTA proposes a general public interest waiver of FTA's Buy America requirements for the two grants, NY-44-X005 for $54.24 million and NY-44-X014 for $159.72 million—awarded to PANYNJ. This public interest waiver is limited to the Hurricane Sandy recovery projects at the WTC Hub only, and does not apply to separately funded resiliency projects. FTA seeks comment from all interested parties on the above public interest waiver. After consideration of the comments, FTA will publish a second notice in the
Office of the Secretary, U.S. Department of Transportation (DOT).
Notice of establishment of Advisory Committee on Transportation Equity (ACTE).
Pursuant to Section 9(a)(2) of the Federal Advisory Committee Act (FACA), and in accordance with Title 41, Code of Federal Regulations, Section 102-3.65, and following consultation with the Committee Management Secretariat, General Services Administration, notice is hereby given that the ACTE will be established for a 2-year period.
The Committee will provide advice and recommendations to the Secretary of Transportation on comprehensive, interdisciplinary issues related to transportation equity from a variety of stakeholders involved in transportation planning, design, research, policy, and advocacy. Specifically, the ACTE will inform the Department about efforts to (1) institutionalize the U.S. DOT Opportunity principles into Agency programs, policies, regulations, and activities; (2) strengthen and establish partnerships with other governmental agencies, including other Federal agencies and State, tribal, or local governments, regarding opportunity issues; (3) promote economic and related forms of opportunity by empowering communities to have a meaningful voice in local and regional transportation decisions; and (4) sharpen enforcement tools to ensure compliance with nondiscrimination programs, policies, regulations, and activities.
The U.S. DOT Opportunity principles are to:
(1) Support transportation projects that connect people to economic and related forms of opportunity and revitalize communities;
(2) Ensure that current and future transportation projects connect and strengthen communities; and
(3) Develop transportation facilities that meaningfully reflect and incorporate the input of all the people and communities they touch.
Additionally, the establishment of the ACTE is necessary for the Department to carry out its mission and in the public interest. The Committee will operate in accordance with the provisions of the Federal Advisory Committee Act and the rules and regulations issued in implementation of that Act.
Barbara McCann, U.S. Department of Transportation, Office of the Secretary, Office of Policy, Room W84-310, 1200 New Jersey Avenue SE., Washington, DC 20590; phone (202) 366-8016; email:
The Secretary of Transportation will appoint up to 15 voting members to the ACTE. Members will be selected with a view toward achieving varied perspectives on transportation equity, including (1) academia; (2) community groups; (3) industry/business; (4) non-government organizations; (5) State and local governments; and (6) federally recognized tribal governments and indigenous groups. The Secretary of Transportation will seek a membership that is fairly balanced in terms of points of view of the affected interests.
The Advisory Committee on Transportation Equity's efforts will include evaluation of the Department's work in using the principles above to achieve Opportunity objectives when carrying out its strategic, research, technological, regulatory, community engagement, and economic policy activities related to transportation and opportunity.
The Committee shall act solely in an advisory capacity and will not exercise program management responsibilities. Decisions directly affecting implementation of transportation policy will remain with the Secretary.
Members of the Advisory Committee on Transportation Equity may be selected to serve either as representative members or as members appointed solely for their expertise. The latter will serve as special Government employees and will be subject to certain ethical restrictions, and such members will be required to submit certain information in connection with the appointment process.
Committee members may serve for a term of 2 years or less and may be reappointed for successive terms, with no more than 2 successive terms. The Chair and Vice Chair of the Committee will be appointed by the Under Secretary of Transportation for Policy from among the selected members, and the Committee is expected to meet
The Committee will make recommendations that provide timely, comprehensive, inclusive advice to the Secretary on transportation opportunity public policy issues that advance the principles of providing opportunity and access to everyone.
Office of the Comptroller of the Currency (OCC), Treasury.
Notice and request for comment.
The OCC, 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 a continuing information collection as required by the Paperwork Reduction Act of 1995 (PRA).
In accordance with the requirements of the PRA, the OCC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number.
The OCC is soliciting comment concerning renewal of its information collection titled, “Appraisals for Higher-Priced Mortgage Loans.”
Comments must be submitted on or before January 3, 2017.
Because paper mail in the Washington, DC area and at the OCC is subject to delay, commenters are encouraged to submit comments by email, if possible. Comments may be sent to: Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, Attention: 1557-0313, 400 7th Street SW., Suite 3E-218, mail stop 9W-11, Washington, DC 20219. In addition, comments may be sent by fax to (571) 465-4326 or by electronic mail to
All comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure.
Shaquita Merritt, OCC Clearance Officer, (202) 649-5490 or, for persons who are deaf or hard of hearing, TTY, (202) 649-5597, Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, 400 7th Street SW., Suite 3E-218, mail stop 9W-11, Washington, DC 20219.
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the OMB for each collection of information that they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) to include 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 title 44 requires Federal agencies to provide a 60-day notice in the
This information collection relates to section 1471 of the Dodd-Frank Act, which added a new section 129H to the Truth in Lending Act (TILA) establishing special appraisal requirements for “higher-risk mortgages.” For certain mortgages with an annual percentage rate that exceeds the average prime offer rate by a specified percentage, creditors must obtain an appraisal or appraisals meeting certain specified standards, provide applicants with a notification regarding the use of the appraisals, and give applicants a copy of the written appraisals used. The statute permits the OCC to issue a rule to include exemptions from these requirements.
The information collection requirements are found in 12 CFR 34.203(c)(1), (c)(2), (d), (e) and (f). This information is required to protect consumers and promote the safety and soundness of creditors making higher-priced mortgage loans (HPMLs) subject to 12 CFR part 34, subpart G. This information is used by creditors to evaluate real estate collateral securing HPMLs subject to 12 CFR 1026.35(c) and by consumers entering these transactions. The collections of information are mandatory for creditors making HPMLs subject to 12 CFR part 34, subpart G.
Under 12 CFR 34.203(e) and (f), a creditor must, no later than the third business day after the creditor receives a consumer's application for an HPML, provide a disclosure to the consumer that informs the consumer of the purpose of the appraisal, that the creditor will provide the consumer with a copy of any appraisal, and that the consumer may choose to have a separate appraisal conducted at the expense of the consumer (Initial Appraisal Disclosure). If a loan is an HPML subject to 12 CFR 1026.35(c), then the creditor is required to obtain a written appraisal prepared by a certified or licensed appraiser who conducts a physical visit of the interior of the property that will secure the transaction (Written Appraisal) and provide a copy of the Written Appraisal to the consumer. Under 12 CFR 34.203(d)((1), a creditor is required to obtain an additional appraisal (Additional Written Appraisal) for an HPML that is subject to 12 CFR part 34, subpart G if: (1) The seller acquired the property securing the loan 90 or fewer days prior to the date of the consumer's agreement to acquire the property and the resale price exceeds the seller's acquisition price by more than 10 percent; or (2) the seller acquired the property securing the loan 91 to 180 days prior to the date of the consumer's agreement to acquire the property and the resale price exceeds the seller's acquisition price by more than 20 percent.
Under 12 CFR 34.203(d)(3) and (4), the Additional Written Appraisal must meet the requirements described in 12 CFR 34.203(c)(1) and also include an analysis of: (1) The difference between the price at which the seller acquired the property and the price the consumer agreed to pay; (2) changes in market conditions between the date the seller acquired the property and the date the consumer agreed to acquire the property; and (3) any improvements
(a) Whether the collection of information is necessary for the proper performance of the functions of the OCC, including whether the information has practical utility;
(b) The accuracy of the OCC's estimate of the information collection burden;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of the collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
(e) Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
Office of Foreign Assets Control, Treasury.
Notice.
The Treasury Department's Office of Foreign Assets Control (OFAC) is publishing the names of 2 individuals and 1 entity whose property and interests in property are blocked pursuant to Executive Order 13224 of September 23, 2001, “Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten To Commit, or Support Terrorism.”
OFAC's action described in this notice was effective on November 1, 2016.
Associate Director for Global Targeting, tel.: 202/622-2420, Assistant Director for Sanctions Compliance & Evaluation, tel.: 202/622-2490, Assistant Director for Licensing, tel.: 202/622-2480, Office of Foreign Assets Control, or Chief Counsel (Foreign Assets Control), tel.: 202/622-2410, Office of the General Counsel, Department of the Treasury (not toll free numbers).
The SDN List and additional information concerning OFAC sanctions programs are available from OFAC's Web site (
On November 1, 2016, OFAC blocked the property and interests in property of the following 2 individuals and 1 entity pursuant to E.O. 13224, “Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten To Commit, or Support Terrorism”:
1. AL-OMGY AND BROTHERS MONEY EXCHANGE (a.k.a. AL OMGE AND BROS COMPANY MONEY EXCHANGE; a.k.a. AL OMGE AND BROS FOR EXCHANGE COMPANY; a.k.a. AL OMGI AND BROS COMPANY; a.k.a. AL-AMAQI LIL-SARAFAH COMPANY; a.k.a. AL-AMQI EXCHANGE; a.k.a. AL-AMQI MONEY EXCHANGE; a.k.a. AL-OMAG AND BROS EXCHANGE; a.k.a. AL-OMAGI & BRO. MONEY EXCHANGE COMPANY; a.k.a. AL-OMAKI EXCHANGE COMPANY; a.k.a. AL-OMAQY EXCHANGE CORPORATION; a.k.a. ALOMGE AND BROS FOR EXCHANGE COMPANY; a.k.a. AL-OMGI EXCHANGE COMPANY; a.k.a. AL-OMGY & BROS. MONEY EXCHANGE; a.k.a. ALOMGY AND BROS MONEY EXCHANGE; a.k.a. ALOMGY AND BROS. EXCHANGE; a.k.a. AL-OMGY COMPANY FOR MONEY EXCHANGE; a.k.a. AL-OMGY EXCHANGE COMPANY; a.k.a. AL-OMQI FOR EXCHANGE; a.k.a. ALOMQY & BROS. FOR MONEY EXCHANGE; a.k.a. AL-OMQY AND BROS COMPANY FOR MONEY EXCHANGE; a.k.a. AL-OMQY FOR EXCHANGING CO.; a.k.a. ALUMGY AND BROS MONEY EXCHANGE; a.k.a. AL-UMGY AND BROS MONEY EXCHANGE; a.k.a. AL-'UMQI BUREAUX DE CHANGE; a.k.a. AL-UMQI CURRENCY EXCHANGE COMPANY; a.k.a. AL-'UMQI GROUP FOR TRADE AND INVESTMENT; a.k.a. AL-UMQI HAWALA; a.k.a. AL-'UMQI MONEY EXCHANGE COMPANY; a.k.a. OMQI COMPANY; a.k.a. UMQI EXCHANGE), Al-Mukalla Branch, Al-Kabas, Near Al-Mukalla Post Office, Al-Mukalla, Hadhramout, Yemen; Galam Street, Taiz, Yemen; 6 Dr. Mostafa Abu Zahra Street, Naser, Cairo, Egypt; Ash Shihr, Hadramawt, Yemen; Qusayir, Hadramawt, Yemen; Hadhramout, Yemen; Aden, Yemen; Taix, Yemen; Abian, Yemen; Sanaa, Yemen; Hudidah, Yemen; Ibb, Yemen; Almhahra, Yemen; Albaidah, Yemen; Shabwah, Yemen; Lahej, Yemen; Suqatra, Yemen [SDGT] (Linked To: AL-QA'IDA IN THE ARABIAN PENINSULA; Linked To: AL-OMGY, Said Salih Abd-Rabbuh; Linked To: AL-OMGY, Muhammad Salih Abd-Rabbuh).
Bureau of Engraving and Printing (BEP), Treasury.
Notice of Privacy Act system of records.
In accordance with the Privacy Act of 1974, as amended, 5 U.S.C. 552a the U.S. Department of the Treasury (“Treasury” or the “Department”), Bureau of Engraving
Submit comments on or before December 5, 2016. This new system will be effective December 5, 2016.
Comments should be sent to Leslie J. Rivera-Pagán, Attorney/Adviser—Privacy Officer, Office of the Chief Counsel-Privacy Office, U.S. Department of the Treasury, Bureau of Engraving and Printing, Room 419-A, 14th & C Streets SW., Washington, DC 20228, Attention: Revisions to Privacy Act Systems of Records. Comments can also be faxed to (202) 874-2951 or emailed to
For general questions and privacy issues please contact: Leslie J. Rivera-Pagán at (202) 874-2500 or
In accordance with the Privacy Act of 1974, 5 U.S.C. 552a, the U.S. Department of the Treasury (Treasury), Bureau of Engraving and Printing (“BEP”) proposes to establish a new Treasury system of records titled, “Treasury/Bureau of Engraving and Printing (BEP)-.051—BEP Chief Counsel Files System of Records.”
The Secretary of the Treasury has delegated final legal authority within Treasury to the General Counsel, who is charged to determine the structural and functional organization of the Legal Division and to establish the policies, procedures, and standards governing its functioning. The mission of the Office of the Chief Counsel of the Bureau of Engraving and Printing (“BEP”) is to provide legal advice or representation to BEP management regarding issues of compliance, investigation, and implementation of matters related to the BEP and the statutes and regulations administered by the BEP. The purpose of this system is to assist BEP attorneys in providing legal advice to BEP management on a wide variety of legal issues. In addition, the system will assist to assess the workload of the legal staff, track the status, progress, and disposition of matters assigned to the legal staff in matters such as litigation and/or administrative proceedings in which BEP is a party, and matters in which the Office of the Chief Counsel must provide advice.
The Office of the Chief Counsel is responsible for collecting, reviewing, redacting, and producing agency records, in support of processing and resolving BEP legal matters. This system has an effect on individual privacy that is balanced by the need to collect and maintain information related to legal advice issued.
Routine uses contained in this notice include sharing with the Department of Justice (DOJ) for legal advice and representation; to a congressional office at the request of an individual; to unions recognized as exclusive bargaining representatives to the extent necessary to obtain information pertinent to an investigation or matter under consideration; to federal, state, local, or foreign agencies, or other public authority agencies responsible for investigating or prosecuting the violations of, or for enforcing, or implementing, a statute, rule, regulation, order, or license, where the disclosing agency becomes aware of a potential violation of civil, administrative, or criminal law, or regulation; to federal, state, local, or other public authority agency maintaining civil, criminal, administrative or other relevant enforcement information or other pertinent information, which has requested information relevant to, or necessary to, the requesting agency's, bureau's, or authority's hiring or retention of an individual, or issuance of a security clearance, license, contract, grant, or other benefit; to a court, adjudicative body, or other administrative body before which BEP is authorized to appear when (a) the agency, or (b) any employee of the agency in his or her official capacity, or (c) any employee of the agency in his or her individual capacity where the Department of Justice or the agency has agreed to represent the employee, or (d) the United States, when the agency determines that litigation is likely to affect the agency, is a party to litigation or has an interest in such litigation, and the use of such records by the agency is deemed to be relevant and necessary to the litigation or administrative proceeding and not otherwise privileged; to a court, magistrate, administrative tribunal, or named parties 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 court order where arguably relevant to a proceeding; to an arbitrator, mediator, or other neutral party, in the context of alternative dispute resolution, to the extent relevant and necessary for resolution of the matters presented, including asserted privileges; and to agencies, entities, or persons during a security or information compromise or breach.
This newly established system will be included in Treasury's inventory of record systems.
Below is the description of the Treasury/Bureau of Engraving and Printing (BEP)-.051—BEP Chief Counsel Files System of Records.” In accordance with 5 U.S.C. 552a(r), Treasury has provided a report of this system of records to the Office of Management and Budget and to Congress.
Department of the Treasury (Treasury)/Bureau of Engraving and Printing (BEP)-.051
Treasury/BEP-.051 BEP Chief Counsel Files
Bureau of Engraving and Printing, Office of the Chief Counsel, District of Columbia Facility, 14th & C Streets SW., Room 419-A, Washington, DC 20028 and Western Currency Facility, 9000 Blue Mound Road, Fort Worth, TX 76131.
Employees and former employees of the Bureau of Engraving and Printing, applicants for employment, adjudicators and legal counsel or other representatives, parties to and persons who have requested information or action from the Office of the Chief Counsel, who are involved in litigations, actions, personnel matters,
• Names, titles, and contact information of the parties and individuals involved, including phone and fax numbers, home and business addresses, and email addresses;
• Case management documents, case and/or matter names, and case and/or matter identification numbers;
• Information and documents relating to grievances, adverse personnel actions, discrimination complaints, and other information and documents related to administrative proceedings;
• Memoranda and litigation related materials including attorney work product;
• Descriptions, summaries, and statuses of issues, cases and/or matters, and assignments;
• Complaints;
• Claim forms;
• Reports of Investigations;
• Accident reports;
• Witness statements and affidavits;
• Pleadings;
• Discovery materials generated in connection with litigation and/or administrative actions;
• Correspondence;
• Administrative files;
• Other records collected or generated in response to matters assigned to the Office of the Chief Counsel.
5 U.S.C. 301, 5520a, 7301, 7351, 7353, 5 U.S.C. App. (Ethics in Government Act of 1978); 28 U.S.C. 2672; 31 U.S.C. 301, 321, 1353, 3721; 42 U.S.C. 659; 44 U.S.C. 3101.
The Office of the Chief Counsel creates and maintains these records to provide legal advice or representation to BEP management regarding issues of compliance, investigation, and implementation of matters related to the BEP and the statutes and regulations administered by the BEP and to maintain historical reference information pertaining to such matters. In addition, the system of records is used to assess the workload of the legal staff, track the status, progress, and disposition of matters assigned to the legal staff, and capture summary information (such as name of principal parties or subjects, case file numbers, and assignments) in matters such as litigation and/or administrative proceedings in which the BEP is a party, and matters in which the Office of the Chief Counsel must provide advice.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, all or a portion of the records or information contained in this system may be disclosed outside Treasury/BEP as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
(1) Appropriate federal, state, local, or foreign agencies, or other public authority agencies responsible for investigating or prosecuting the violations of, or for enforcing, or implementing, a statute, rule, regulation, order, or license, where the disclosing agency becomes aware of a potential violation of civil, administrative, or criminal law, or regulation;
(2) To federal, state, local, or other public authority agency maintaining civil, criminal, administrative or other relevant enforcement information or other pertinent information, which has requested information relevant to, or necessary to, the requesting agency's, bureau's, or authority's hiring or retention of an individual, or issuance of a security clearance, license, contract, grant, or other benefit;
(3) To a court, adjudicative body, or other administrative body before which BEP is authorized to appear when (a) the agency, or (b) any employee of the agency in his or her official capacity, or (c) any employee of the agency in his or her individual capacity where the Department of Justice or the agency has agreed to represent the employee, or (d) the United States, when the agency determines that litigation is likely to affect the agency, is a party to litigation or has an interest in such litigation, and the use of such records by the agency is deemed to be relevant and necessary to the litigation or administrative proceeding and not otherwise privileged;
(4) To a court, magistrate, administrative tribunal, or named parties 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 court order where arguably relevant to a proceeding;
(5) To an arbitrator, mediator, or other neutral party, in the context of alternative dispute resolution, to the extent relevant and necessary for resolution of the matters presented, including asserted privileges;
(6) The U.S. Department of Justice (“DOJ”) for its use in providing legal advice to the BEP or in representing the BEP in a proceeding before a court, adjudicative body, or other administrative body before which the BEP is authorized to appear, where the BEP deems DOJ's use of such information relevant and necessary to the litigation, and such proceeding names as a party or interests:
(a) The BEP or any component of it;
(b) Any employee of the BEP in his or her official capacity;
(c) Any employee of the BEP in his or her individual capacity where DOJ has agreed to represent the employee; or
(d) The United States, where the BEP determines that litigation is likely to affect the BEP or any of its components;
(7) Unions recognized as exclusive bargaining representatives under the Civil Service Reform Act of 1978, 5 U.S.C. 7111 and 7114 to the extent necessary to obtain information pertinent to an investigation or matter under consideration;
(8) To a congressional office in response to an inquiry made at the request of the individual to whom the record pertains;
(9) To appropriate agencies, entities, and persons when (a) the Department suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the Department has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the Department or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Department's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Records in this system are stored electronically or on paper in secure facilities in a locked drawer behind a locked door. The records are stored on magnetic disc, tape, or electronic records.
Records are retrievable by the name of the party or individual who are subjects
Access to electronic and paper records is limited to the Office of the Chief Counsel personnel. Paper records are maintained in locked facilities and/or cabinets with restricted access. Electronic records are restricted to authorized personnel who have been issued non-transferrable access passwords.
Paper and electronic records are retained and disposed in accordance with the Bureau of Engraving and Printing Records Schedule, N1-318-04-3, and General Records Schedules (GRS) 1, 2.8, 4.1, 4.2, and 23, as approved by the National Archives and Records Administration.
Chief Counsel, Bureau of Engraving and Printing, Office of the Chief Counsel, District of Columbia Facility, 14th & C Streets SW., Room 419-A, Washington, DC 20028 and Western Currency Facility, 9000 Blue Mound Road, Fort Worth, TX 76131.
Individuals seeking to determine whether this system of records contains their information should address written inquiries in accordance with 31 CFR Part1 to the Disclosure Officer, Bureau of Engraving and Printing, Office of the Chief Counsel—FOIA and Transparency Services, 14th & C Streets SW., Room 419-A, Washington, DC 20228.
See “Notification procedure” above.
See “Notification procedure” above.
The sources of the records include: (1) Existing BEP personnel and records, (2) subject of the record, (3) parties and witnesses to disputed matters of fact or law, (4) Congressional offices, and, (5) federal, state, and/or local agencies.
None.
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule with comment period.
The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) repeals the Medicare sustainable growth rate (SGR) methodology for updates to the physician fee schedule (PFS) and replaces it with a new approach to payment called the Quality Payment Program that rewards the delivery of high-quality patient care through two avenues: Advanced Alternative Payment Models (Advanced APMs) and the Merit-based Incentive Payment System (MIPS) for eligible clinicians or groups under the PFS. This final rule with comment period establishes incentives for participation in certain alternative payment models (APMs) and includes the criteria for use by the Physician-Focused Payment Model Technical Advisory Committee (PTAC) in making comments and recommendations on physician-focused payment models (PFPMs). Alternative Payment Models are payment approaches, developed in partnership with the clinician community, that provide added incentives to deliver high-quality and cost-efficient care. APMs can apply to a specific clinical condition, a care episode, or a population. This final rule with comment period also establishes the MIPS, a new program for certain Medicare-enrolled practitioners. MIPS will consolidate components of three existing programs, the Physician Quality Reporting System (PQRS), the Physician Value-based Payment Modifier (VM), and the Medicare Electronic Health Record (EHR) Incentive Program for Eligible Professionals (EPs), and will continue the focus on quality, cost, and use of certified EHR technology (CEHRT) in a cohesive program that avoids redundancies. In this final rule with comment period we have rebranded key terminology based on feedback from stakeholders, with the goal of selecting terms that will be more easily identified and understood by our stakeholders.
In commenting, please refer to file code CMS-5517-FC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways (please choose only one of the ways listed):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
4.
a. For delivery in Washington, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201.
(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786-7195 in advance to schedule your arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.
For information on viewing public comments, see the beginning of the
Molly MacHarris, (410) 786-4461, for inquiries related to MIPS. James P. Sharp, (410) 786-7388, for inquiries related to APMs.
The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, enacted April 16, 2015), amended title XVIII of the Social Security Act (the Act) to repeal the Medicare sustainable growth rate, to reauthorize the Children's Health Insurance Program, and to strengthen Medicare access by improving physician and other clinician payments and making other improvements. This rule finalizes policies to improve physician and other clinician payments by changing the way Medicare incorporates quality measurement into payments and by developing new policies to address and incentivize participation in Alternative Payment Models (APMs). These unified policies to promote greater value within the healthcare system are referred to as the Quality Payment Program.
The MACRA, landmark bipartisan legislation, advances a forward-looking, coordinated framework for health care providers to successfully take part in the CMS Quality Payment Program that rewards value and outcomes in one of two ways:
• Advanced Alternative Payment Models (Advanced APMs).
• Merit-based Incentive Payment System (MIPS).
The MACRA marks a milestone in efforts to improve and reform the health care system. Building off of the successful coverage expansions and improvements to access under the Patient Protection and Affordable Care Act (Affordable Care Act), the MACRA puts an increased focus on the quality and value of care delivered. By implementing MACRA to promote participation in certain APMs, such as the Shared Saving Program, Medical Home Models, and innovative episode payment models for cardiac and joint care, and by paying eligible clinicians for quality and value under MIPS, we support the nation's progress toward achieving a patient-centered health care system that delivers better care, smarter spending, and healthier people and communities. By driving significant changes in how care is delivered to make the health care system more responsive to patients and families, we believe the Quality Payment Program supports eligible clinicians in improving the health of their patients, including encouraging interested eligible clinicians in their successful transition into APMs. To implement this vision, we are finalizing a program that emphasizes high-quality care and patient outcomes while minimizing burden on eligible clinicians and that is flexible, highly transparent, and improves over time with input from clinical practices. To aid in this process, we have sought feedback from the health care community through various public avenues and solicited comment through the proposed rule. As we establish policies for effective implementation of the MACRA, we do so with the explicit understanding that technology, infrastructure, physician support systems, and clinical practices will change over the next few years. In addition, we are aware of the diversity of clinician practices in their experience with quality-based payments. As a result of these factors, we expect the Quality Payment Program to evolve over multiple years in order to achieve our national goals. In the early years of the program, we will begin by laying the groundwork for expansion towards an innovative, outcome-focused, patient-centered, resource-effective health system. Through a staged approach, we can develop policies that are operationally feasible and made in consideration of system capabilities and our core strategies to drive progress and reform efforts. Thus, due to this staged approach, we are finalizing the rule with a comment period. We commit to continue iterating on these policies.
The Quality Payment Program aims to do the following: (1) Support care improvement by focusing on better outcomes for patients, decreased provider burden, and preservation of independent clinical practice; (2) promote adoption of alternative payment models that align incentives across healthcare stakeholders; and (3) advance existing efforts of Delivery System Reform, including ensuring a smooth transition to a new system that promotes high-quality, efficient care through unification of CMS legacy programs.
This final rule with comment period establishes the Quality Payment Program and its two interrelated pathways: Advanced APMs and the MIPS. This final rule with comment period establishes incentives for participation in Advanced APMs, supporting the Administration's goals of transitioning from fee-for-service (FFS) payments to payments for quality and value, including approaches that focus on better care, smarter spending, and healthier people. This final rule with comment period also includes definitions of Qualifying APM Participants (QPs) in Advanced APMs and outlines the criteria for use by the Physician-Focused Payment Model Technical Advisory Committee (PTAC) in making comments and recommendations to the Secretary on physician-focused payment models (PFPMs).
MIPS is a new program for certain Medicare-participating eligible
We solicited and reviewed over 4000 comments and had over 100,000 physicians and other stakeholders attend our outreach sessions. Through this outreach, we created six strategic objectives to drive continued progress and improvement.
These objectives guided our final policies and will guide our future rulemaking in order to design, implement and evolve a Quality Payment Program that aims to improve health outcomes, promote smarter spending, minimize burden of participation, and provide fairness and transparency in operations. These strategic objectives are as follows: (1) To improve beneficiary outcomes and engage patients through patient-centered Advanced APM and MIPS policies; (2) to enhance clinician experience through flexible and transparent program design and interactions with easy-to-use program tools; (3) to increase the availability and adoption of robust Advanced APMs; (4) to promote program understanding and maximize participation through customized communication, education, outreach and support that meet the needs of the diversity of physician practices and patients, especially the unique needs of small practices; (5) to improve data and information sharing to provide accurate, timely, and actionable feedback to clinicians and other stakeholders; and (6) to ensure operational excellence in program implementation and ongoing development. More information on these objectives and the Quality Payment Program can be found at
With these objectives we recognize that the Quality Payment Program provides new opportunities to improve care delivery by supporting and rewarding clinicians as they find new ways to engage patients, families and caregivers and to improve care coordination and population health management. In addition, we recognize that by developing a program that is flexible instead of one-size-fits-all, clinicians will be able to choose to participate in a way that is best for them, their practice, and their patients. For clinicians interested in APMs, we believe that by setting ambitious yet achievable goals, eligible clinicians will move with greater certainty toward these new approaches of delivering care. To these ends, and to ensure this program works for all stakeholders, we further recognize that we must provide ongoing education, support, and technical assistance so that clinicians can understand program requirements, use available tools to enhance their practices, and improve quality and progress toward participation in alternative payment models if that is the best choice for their practice. Finally, we understand that we must achieve excellence in program management, focusing on customer needs, promoting problem-solving, teamwork, and leadership to provide continuous improvements in the Quality Payment Program.
Clinicians have told us that they do not separate their patient care into domains, and that the Quality Payment Program needs to reflect typical clinical workflows in order to achieve its goals of better patient care. Advanced APMs, the focus of one pathway of the Quality Payment Program, contribute to better care and smarter spending by allowing physicians and other clinicians to deliver coordinated, customized, high-quality care to their patients within a streamlined payment system. Within MIPS, the second pathway of the Quality Payment Program, we believe that the unification into one Quality Payment Program can best be accomplished by making connections across the four pillars of the MIPS payment structure identified in the MACRA legislation—quality, clinical practice improvement activities (referred to as “improvement activities”), meaningful use of CEHRT (referred to as “advancing care information”), and resource use (referred to as “cost”)—and by emphasizing that the Quality Payment Program is at its core about improving the quality of patient care. Indeed, the bedrock of the Quality Payment Program is high-quality, patient-centered care followed by useful feedback, in a continuous cycle of improvement. The principal way MIPS measures quality of care is through evidence-based clinical quality measures (CQMs) which MIPS eligible clinicians can select, the vast majority of which are created by or supported by clinical leaders and endorsed by a consensus-based process. Over time, the portfolio of quality measures will grow and develop, driving towards outcomes that are of the greatest importance to patients and clinicians. Through MIPS, we have the opportunity to measure quality not only through clinician-proposed measures, but to take it a step further by also accounting for activities that physicians themselves identify: Namely, practice-driven quality improvement. The MACRA requires us to measure whether technology is used meaningfully. Based on significant feedback, this area is simplified into supporting the exchange of patient information and how technology specifically supports the quality goals selected by the practice. The cost performance category has also been simplified and weighted at zero percent of the final score for the transition year of CY 2017. Given the primary focus on quality, we have accordingly indicated our intention to align these measures fully to the quality measures over time in the scoring system (see section II.E.6.a. for further details). That is, we are establishing special policies for the first year of the Quality Payment Program, which we refer to as the “transition year” throughout this final rule with comment period; this transition year corresponds to the first performance period of the program, calendar year (CY) 2017, and the first payment year, CY 2019. We envision that it will take a few years to reach a steady state in the program, and we therefore anticipate a ramp-up process and gradual transition with less financial risk for clinicians in at least the first 2 years. In the transition year in 2017, we will test this performance category alignment, for example by allowing certain improvement activities that are completed using CEHRT to achieve a bonus score in the advancing care information performance category with the intent of analyzing adoption, and in future years, potentially adding activities that reinforce integration of the program. Our hope is for the program to evolve to the point where all the clinical activities captured in MIPS across the four performance categories reflect the single, unified goal of quality improvement.
We recognize, as described through many insightful comments, that many eligible clinicians face challenges in understanding the requirements and being prepared to participate in the Quality Payment Program in 2017. As a result, we have decided to finalize transitional policies throughout this final rule with comment period, which will focus the program in its initial years on encouraging participation and educating clinicians, all with the primary goal of placing the patient at the center of the healthcare system. At the same time, we will also increase opportunities to join Advanced APMs, allowing eligible clinicians who chose to do so an opportunity to participate.
Given the wide diversity of clinical practices, the initial development period of the Quality Payment Program implementation would allow physicians to pick their pace of participation for the first performance period that begins January 1, 2017. Eligible clinicians will have three flexible options to submit data to MIPS and a fourth option to join Advanced APMs in order to become QPs, which would ensure they do not receive a negative payment adjustment in 2019.
In the transition year CY 2017 of the program, this rule finalizes a period during which clinicians and CMS will build capabilities to report and gain experience with the program. Clinicians can choose their course of participation in this year with four options.
(1) Clinicians can choose to report to MIPS for a full 90-day period or, ideally, the full year, and maximize the MIPS eligible clinician's chances to qualify for a positive adjustment. In addition, MIPS eligible clinicians who are exceptional performers in MIPS, as shown by the practice information that they submit, are eligible for an additional positive adjustment for each year of the first 6 years of the program.
(2) Clinicians can choose to report to MIPS for a period of time less than the full year performance period 2017 but for a full 90-day period at a minimum and report more than one quality measure, more than one improvement activity, or more than the required measures in the advancing care information performance category in order to avoid a negative MIPS payment adjustment and to possibly receive a positive MIPS payment adjustment.
(3) Clinicians can choose to report one measure in the quality performance category; one activity in the improvement activities performance category; or report the required measures of the advancing care information performance category and avoid a negative MIPS payment adjustment. Alternatively, if MIPS eligible clinicians choose to not report even one measure or activity, they will receive the full negative 4 percent adjustment.
(4) MIPS eligible clinicians can participate in Advanced APMs, and if they receive a sufficient portion of their Medicare payments or see a sufficient portion of their Medicare patients through the Advanced APM, they will qualify for a 5 percent bonus incentive payment in 2019.
We are finalizing the 2017 performance period for the 2019 MIPS payment year to be a transition year as part of the development period in the program. For this transition year, for MIPS the performance threshold will be lowered to a threshold of 3 points. Clinicians who achieve a final score of 70 or higher will be eligible for the exceptional performance adjustment, funded from a pool of $500 million.
For full participation in MIPS and in order to achieve the highest possible final scores, MIPS eligible clinicians are encouraged to submit measures and activities in all three integrated performance categories: Quality, improvement activities, and advancing care information. To address public comments on the cost performance category, the weighting of the cost performance category has been lowered to 0 percent for the transition year. For full participation in the quality performance category, clinicians will report on six quality measures, or one specialty-specific or subspecialty-specific measure set. For full participation in the advancing care information performance category, MIPS eligible clinicians will report on five required measures. For full participation in the improvement activities performance category, clinicians can engage in up to four activities, rather than the proposed six activities, to earn the highest possible score of 40.
For the transition year CY 2017, for quality, clinicians who submit one out of at least six quality measures will meet the MIPS performance threshold of 3; however, more measures are required for groups who submit measures using the CMS Web Interface. For the transition year CY 2017, for quality, higher measure points may be awarded based on achieving higher performance in the measure. For improvement activities, attesting to at least one improvement activity will also be sufficient to meet the MIPS performance threshold in the transition year CY 2017. For advancing care information, clinicians reporting on the required measures in that category will meet the performance threshold in the transition year. These transition year policies for CY 2017 will encourage participation by clinicians and will provide a ramp up period for clinicians to prepare for higher performance thresholds in the second year of the program.
Historical evidence has shown that clinical practices of all sizes can successfully submit data, including over 110,000 solo and small practices with 15 or fewer clinicians who participated in PQRS in 2015. The transition year and development period approach gives clinicians structured, practical choices that can best suit their practices. Resources will be made available to assist clinicians and practices through this transition. The hope is that by lowering the barriers to participation at the outset, we can set the foundation for a program that supports long-term, high-quality patient care through feedback and open communication between CMS and other stakeholders.
We anticipate that the iterative learning and development period will last longer than the first year, CY 2017, of the program as we move towards a steady state; therefore, we envision CY 2018 to also be transitional in nature to provide a ramp-up of the program and of the performance thresholds. We anticipate making proposals on the parameters of this second transition year through rule-making in 2017.
This final rule with comment period will sunset payment adjustments under the current Medicare EHR Incentive Program for EPs (section 1848(o) of the Act), the PQRS (section 1848(k) and (m) of the Act), and the VM (section 1848(p) of the Act) programs after CY2018. Components of these three programs will be carried forward into MIPS. This final rule with comment period establishes new subpart O of our regulations at 42 CFR part 414 to implement the new MIPS program as required by the MACRA.
In developing this final rule with comment period, we sought feedback from stakeholders throughout the process, including through Requests for Information in October 2015 and through the comment process for the proposed rule from April to June 2016. We received thousands of comments from a broad range of sources including professional associations and societies, physician practices, hospitals, patient
We intend to continue open communication with stakeholders, including consultation with tribes and tribal officials, on an ongoing basis as we develop the Quality Payment Program in future years.
As outlined above, protection of small, independent practices is an important thematic objective for this final rule with comment. For 2017, many small practices will be excluded from new requirements due to the low-volume threshold, which has been set at less than or equal to $30,000 in Medicare Part B allowed charges or less than or equal to 100 Medicare patients, representing 32.5 percent of pre-exclusion Medicare clinicians but only 5 percent of Medicare Part B spending. Stakeholder comments suggested setting a higher low-volume threshold for exclusion from MIPS but allowing clinicians that would be excluded by the threshold to opt in to the program if they wished to report to MIPS and receive a MIPS payment adjustment for the year. We considered this option but determined that it was inconsistent with the statutory MIPS exclusion based on the low-volume threshold. We anticipate that more clinicians will be determined to be eligible to participate in the program in future years.
MACRA also provides that solo and small practices may join “virtual groups” and combine their MIPS reporting. Many commenters suggested that we allow groups with more than 10 clinicians to participate as virtual groups. As noted, the statute limits the virtual group option to individuals and groups of not more than 10 clinicians. We are not implementing virtual groups in the transition year CY 2017 of the program; however, through the policies of the transition year and development period, we believe we have addressed some of the concerns expressed by clinicians hesitant to participate in the Quality Payment Program. CMS wants to make sure the virtual group technology is meaningful and simple to use for clinicians, and we look forward to stakeholder engagement on how to structure and implement virtual groups in future years of the program.
In keeping with the objectives of providing education about the program and maximizing participation, and as mandated by the MACRA, $100 million in technical assistance will be available to MIPS eligible clinicians in small practices, rural areas, and practices located in geographic health professional shortage areas (HPSAs), including IHS, tribal, and urban Indian clinics, through contracts with quality improvement organizations, regional health collaboratives, and others to offer guidance and assistance to MIPS eligible clinicians in practices of 15 or fewer MIPS eligible clinicians. Priority will be given to practices located in rural areas, defined as clinicians in zip codes designated as rural, using the most recent Health Resources and Services Administration (HRSA) Area Health Resource File data set available; medically underserved areas (MUAs); and practices with low MIPS final scores or in transition to APM participation. The MACRA also includes provisions requiring an examination of the pooling of financial risk for physician practices, in particular for small practices. Specifically, section 101(c)(2)(C) of MACRA requires the Government Accountability Office (GAO) to submit a report to Congress, not later than January 1, 2017, examining whether entities that pool financial risk for physician practices, such as independent risk managers, can play a role in supporting physician practices, particularly small physician practices, in assuming financial risk for the treatment of patients. We have been closely engaged with the GAO throughout their study to better understand the unique needs and challenges faced by clinicians in small practices and practices in rural or health professional shortage areas. We have provided information to the GAO, and the GAO has shared some of their initial findings regarding these challenges. We look forward to further engagement with the GAO on this topic and to the release of GAO's final report. Using the knowledge obtained from small practices, other stakeholders, and the public, as well as from GAO, we continue to work to improve the flexibility and support available to small, underserved, and rural practices. Throughout the evolution of the Quality Payment Program that will unfold over the years to come, CMS is committed to working together with stakeholders to address the unique challenges these practices encounter.
Using updated policies for the transition year and development period, we performed an updated regulatory impact analysis, including for small and solo practices. With the extensive changes to policy and increased flexibility, we believe that estimating impacts of this final rule with comment period using only historic 2015 quality submission data significantly overestimates the impact on small and solo practices. Although small and solo practices have historically been less likely to engage in PQRS and quality reporting, we believe that small and solo practices will respond to MIPS by participating at a rate close to that of other practice sizes. In order to quantify the impact of the rule on MIPS eligible clinicians, including small and solo practices, we have prepared two sets of analyses that assume the participation rates for some categories of small practices will be similar to those of other practice size categories. Specifically, our primary analysis assumes that each practice size grouping will achieve at least 90 percent participation rate and our alternative assumption is that each practice size grouping will achieve at least an 80 percent participation rate. In both sets of analyses, we estimate that over 90 percent of MIPS eligible clinicians will receive a positive or neutral MIPS payment adjustment in the transition year, and that at least 80 percent of clinicians in small and solo practices with 1-9 clinicians will receive a positive or neutral MIPS payment adjustment.
In this rule, we finalize requirements we will use for the purposes of the incentives for participation in Advanced
APMs represent an important step forward in the Administration's efforts to move our healthcare system from volume-based to value-based care. APMs that meet the criteria to be Advanced APMs provide the pathway through which eligible clinicians, who would otherwise participate in MIPS, can become Qualifying APM Participants (QPs), and therefore, earn incentive payments for their Advanced APM participation. In the proposed rule, we estimated that 30,000 to 90,000 clinicians would be QPs in 2017. With new Advanced APMs expected to become available for participation in 2017 and 2018, including the Medicare ACO Track 1 Plus (1+), and anticipated amendments to reopen applications for or modify current APMs, such as the Maryland All-Payer Model and Comprehensive Care for Joint Replacement (CJR) model, we anticipate higher numbers of QPs—approximately 70,000 to 120,000 in 2017 and 125,000 to 250,000 in 2018.
As discussed in section II.F.4.b. of this final rule with comment period, we are exploring development of the Medicare ACO Track 1+ Model to begin in 2018. The model would be voluntary for ACOs currently participating in Track 1 of the Shared Savings Program or ACOs seeking to participate in the Shared Savings Program for the first time. It would test a payment model that incorporates more limited downside risk than is currently present in Tracks 2 or 3 of the Shared Savings Program but sufficient financial risk in order to be an Advanced APM. We will announce additional information about the model in the future.
This rule finalizes two types of Advanced APMs: Advanced APMs and Other Payer Advanced APMs. To be considered an Advanced APM, an APM must meet all three of the following criteria, as required under section 1833(z)(3)(D) of the Act: (1) The APM must require participants to use CEHRT; (2) The APM must provide for payment for covered professional services based on quality measures comparable to those in the quality performance category under MIPS and; (3) The APM must either require that participating APM Entities bear risk for monetary losses of a more than nominal amount under the APM, or be a Medical Home Model expanded under section 1115A(c) of the Act. In this rule, we finalize proposals pertaining to all of these criteria.
To be an Other Payer Advanced APM, as set forth in section 1833(z)(2) of the Act, a payment arrangement with a payer (for example, Medicaid or a commercial payer) must meet all three of the following criteria: (1) The payment arrangement must require participants to use CEHRT; (2) The payment arrangement must provide for payment for covered professional services based on quality measures comparable to those in the quality performance category under MIPS and; (3) The payment arrangement must require participants to either bear more than nominal financial risk if actual aggregate expenditures exceed expected aggregate expenditures; or be a Medicaid Medical Home Model that meets criteria comparable to Medical Home Models expanded under section 1115A(c) of the Act.
We are completing an initial set of Advanced APM determinations that we will release as soon as possible but no later than January 1, 2017. For new APMs that are announced after the initial determination, we will include Advanced APM determinations in conjunction with the first public notice of the APM, such as the Request for Applications (RFA) or final rule. All determinations of Advanced APMs will be posted on our Web site and updated on an ad hoc basis, but no less frequently than annually, as new APMs become available and others end or change.
An important avenue for the creation of innovative payment models is the PTAC, created by the MACRA. The PTAC is an 11-member independent federal advisory committee to the HHS Secretary. The PTAC will review stakeholders' proposed PFPMs, and make comments and recommendations to the Secretary regarding whether the PFPMs meet criteria established by the Secretary. PTAC comments and recommendations will be reviewed by the CMS Innovation Center and the Secretary, and we will post a detailed response to them on the CMS Web site.
QPs are eligible clinicians in an Advanced APM who have a certain percentage of their patients or payments through an Advanced APM. QPs are excluded from MIPS and receive a 5 percent incentive payment for a year beginning in 2019 through 2024. We finalize our proposal that professional services furnished at Critical Access Hospitals (CAHs), Rural Health Clinics (RHCs), and Federally Qualified Health Centers (FQHCs) that meet certain criteria be counted towards the QP determination using the patient count method.
We finalize definitions of Medical Home Model and Medicaid Medical Home Model and the unique standards by which Medical Home Models may meet the financial risk criterion to be an Advanced APM.
The statute sets thresholds for the level of participation in Advanced APMs required for an eligible clinician to become a QP for a year. The Medicare Option, based on Part B payments for covered professional services or counts of patients furnished covered professional services under Part B, is applicable beginning in the payment year 2019. The All-Payer Combination Option, which utilizes the Medicare Option as well as an eligible clinician's participation in Other Payer Advanced APMs, is applicable beginning in the payment year 2021. For eligible clinicians to become QPs through the All-Payer Combination Option, an Advanced APM Entity or eligible clinician must participate in an Advanced APM under Medicare and also submit information to CMS so that we can determine whether payment arrangements with non-Medicare payers are an Other Payer Advanced APMs and whether an eligible clinician meets the requisite QP threshold of participation. We are finalizing our methodologies to evaluate eligible clinicians using the Medicare and All-Payer Combination Options.
We are finalizing the two methods by which we will calculate Threshold Scores to compare to the QP thresholds and make QP determinations for eligible clinicians. The payment amount method assesses the amount of payments for Part B covered professional services that are furnished through an Advanced APM. The patient count method assesses the amount of patients furnished Part B covered professional services through an Advanced APM.
We are finalizing our proposal to identify individual eligible clinicians by a unique APM participant identifier using the individuals' APM, APM Entity, and TIN/NPI combinations, and to assess as an APM Entity group all individual eligible clinicians listed as participating in an Advanced APM Entity to determine their QP status for a year. We are finalizing that if an individual eligible clinician who participates in multiple Advanced APM Entities does not achieve QP status through participation in any single APM Entity, we will assess the eligible
We are finalizing the method to calculate and disburse the lump-sum APM Incentive Payments to QPs, and we are finalizing a specific approach for calculating the APM Incentive Payment when a QP also receives non-FFS payments or has received payment adjustments through the Medicare EHR Incentive Program, PQRS, VM, or MIPS during the prior period used for determining the APM Incentive Payment.
We are finalizing a modified policy such that, following a final determination that an Advanced APM Entity group or eligible clinician is determined to be a Partial Qualifying APM Participant (Partial QP), the Advanced APM Entity—or eligible clinician in the case of an individual determination—will make an election on behalf of all of its eligible clinicians in the group of whether to report to MIPS, thus making all eligible clinicians in the Advanced APM Entity group subject to MIPS payment adjustments; or not report to MIPS, thus excluding all eligible clinicians in the APM Entity group from MIPS adjustments. We finalize our proposals to vet and monitor APM Entities, Advanced APM Entities, and eligible clinicians participating in those entities. We are finalizing a definition for PFPMs and criteria for use by the PTAC in fulfilling its responsibility to evaluate proposals for PFPMs.
We are finalizing an accelerated timeline for making QP determinations, and will notify eligible clinicians of their QP status as soon as possible, in advance of the end of the MIPS performance period so that QPs will know whether they are excluded from MIPS prior to having to submit information to CMS for purposes of MIPS.
We are finalizing the requirement that MIPS eligible clinicians, as well as EPs, eligible hospitals, and CAHs under the existing Medicare and Medicaid EHR Incentive Programs demonstrate cooperation with certain provisions concerning blocking the sharing of information under section 106(b)(2) of the MACRA and, separately, to demonstrate engagement with activities that support health care providers with the performance of their CEHRT such as cooperation with ONC direct review of certified health information technologies.
In establishing MIPS, this final rule with comment period will define MIPS participants as “MIPS eligible clinicians” rather than “MIPS EPs” as that term is defined at section 1848(q)(1)(C) and used throughout section 1848(q) of the Act. MIPS eligible clinicians will include physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and groups that include such clinicians who bill under Medicare Part B. The rule finalizes definitions and requirements for groups. In addition to finalizing definitions for MIPS eligible clinicians, the rule also finalizes rules for the specific Medicare-enrolled clinicians that will be excluded from MIPS, including newly Medicare-enrolled MIPS eligible clinicians, QPs, certain Partial QPs, and clinicians that fall under the finalized low-volume threshold.
For the 2017 performance period, we estimate that more than half of clinicians—approximately 738,000 to 780,000—billing under the Medicare PFS will be excluded from MIPS due to several factors, including the MACRA itself. We estimate that nearly 200,000 clinicians, or approximately 14.4 percent, are not one of the eligible types of clinicians for the transition year CY 2017 of MIPS under section 1848(q)(1)(C) of the Act. The largest cohort of clinicians excluded from MIPS is low-volume clinicians, defined as those clinicians with less than or equal to $30,000 in allowed charges or less than or equal to 100 Medicare patients, representing approximately 32.5 percent of all clinicians billing Medicare Part B services or over 380,000 clinicians. Additionally, between 70,000 and 120,000 clinicians (approximately 5-8 percent of all clinicians billing under the Medicare Part B) will be excluded from MIPS due to being QPs based on participation in Advanced APMs. In aggregate, the eligible clinicians excluded from MIPS represent only 22 to 27 percent of total Part B allowed charges.
This rule finalizes MIPS performance standards and a minimum MIPS performance period of any 90 continuous days during CY 2017 (January 1 through December 31) for all measures and activities applicable to the integrated performance categories. After consideration of public comments, this rule finalizes a shorter than annual performance period in 2017 to allow flexible participation options for MIPS eligible clinicians as the program begins and evolves over time. For performance periods occurring in 2017, MIPS eligible clinicians will be able to pick a pace of participation that best suits their practices, including submitting data, in special circumstances as discussed in section II.E.5. of this rule, for a period of less than 90 days, to avoid a negative MIPS payment adjustment. Further, we are finalizing our proposal to use performance in 2017 as the performance period for the 2019 payment adjustment. Therefore, the first performance period will start in 2017 and consist of a minimum period of any 90 continuous days during the calendar year in order for clinicians to be eligible for payment adjustment above neutral. Performance in that period of 2017 will be used to determine the 2019 payment adjustment. This timeframe is needed to allow data and claims to be submitted and data analysis to occur in the initial years. In subsequent years, we intend to explore ways to shorten the period between the performance period and the payment year, and ongoing performance feedback will be provided more frequently. The final policies for CY 2017 provide flexibilities to ensure clinicians have ample participation opportunities.
As directed by the MACRA, this rule finalizes measures, activities, reporting, and data submission standards across four integrated performance categories: Quality, cost, improvement activities, and advancing care information, each linked by the same overriding mission of supporting care improvement under the vision of one Quality Payment Program. Consideration will be given to the application of measures and activities to non-patient facing MIPS eligible clinicians.
Under the requirements finalized in this rule, there will be options for reporting as an individual MIPS eligible clinician or as part of a group. Some data may be submitted via relevant third party intermediaries, such as qualified clinical data registries (QCDRs), health IT vendors,
Within each performance category, we are finalizing specific requirements for full participation in MIPS which involves submitting data on quality measures, improvement activities, and use of certified EHR technology on a minimum of any continuous 90 days up to the full calendar year in 2017 in order to be eligible for a positive MIPS payment adjustment. It is at the MIPS eligible clinician's discretion whether to submit data for the same 90-day period for the various measures and activities or for different time periods for different measures and activities. Note that during the 2017 transition year, MIPS eligible clinicians may choose to report a minimum of a single measure in the quality performance category, a single activity in the improvement activities performance category or the required measures in the advancing care information performance category, in order to avoid a negative payment adjustment. For full participation in MIPS, the specific requirements are as follows:
Quality measures will be selected annually through a call for quality measures process, and a final list of quality measures will be published in the
Alternatively, for a minimum of a continuous 90-day period, the MIPS eligible clinician or group can report one specialty-specific measure set, or the measure set defined at the subspecialty level, if applicable. If the measure set contains fewer than six measures, MIPS eligible clinicians will be required to report all available measures within the set. If the measure set contains six or more measures, MIPS eligible clinicians can choose six or more measures to report within the set. Regardless of the number of measures that are contained in the measure set, MIPS eligible clinicians reporting on a measure set will be required to report at least one outcome measure or, if no outcome measures are available in the measure set, report another high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures) within the measure set in lieu of an outcome measure.
Improvement activities are those that support broad aims within healthcare delivery, including care coordination, beneficiary engagement, population management, and health equity. In response to comments from experts and stakeholders across the healthcare system, improvement activities were given relative weights of high and medium. We are reducing the number of activities required to achieve full credit from six medium-weighted or three high-weighted activities to four medium-weighted or two high-weighted activities to receive full credit in this performance category in CY 2017. For small practices, rural practices, or practices located in geographic health professional shortage areas (HPSAs), and non-patient facing MIPS eligible clinicians, we will reduce the requirement to only one high-weighted or two medium-weighted activities. We also expand our definition of how CMS will recognize a MIPS eligible clinician or group as being a certified patient-centered medical home or comparable specialty practice to include certification from a national program, regional or state program, private payer or other body that administers patient-centered medical home accreditation. As previously mentioned, in recognition of improvement activities as supporting the central mission of a unified Quality Payment Program, we will include a designation in the inventory of improvement activities of which activities also qualify for the advancing care information bonus score, consistent with our desire to recognize that EHR technology is often deployed to improve care in ways that our programs should recognize.
Measures and objectives in the advancing care information performance category focus on the secure exchange of health information and the use of certified electronic health record technology (CEHRT) to support patient engagement and improved healthcare quality. We are maintaining alignment of the advancing care information performance category with the other integrated performance categories for MIPS. We are reducing the total number of required measures from eleven in the proposed rule to only five in our final policy. All other measures would be optional for reporting. Reporting on all five of the required measures would earn the MIPS eligible clinician 50 percent. Reporting on the optional measures would allow a clinician to earn a higher score. For the transition year, we will award a bonus score for improvement activities that utilize CEHRT and for reporting to public health or clinical data registries.
Public commenters requested that the advancing care information performance category allow for reporting on “use cases” such as the use of CEHRT to manage referrals and consultations (“closing the referral loop”) and other practice-based activities for which CEHRT is used as part of the typical workflow. This is an area we intend to explore in future rulemaking but did not finalize any such policies in this rule. However, for the 2017 transition year, we will award bonus points for improvement activities that utilize CEHRT and for reporting to a public health or clinical data registry, reflecting the belief that the advancing care information performance category should align with the other performance categories to achieve the unified goal of quality improvement.
For the transition year, we are finalizing a weight of zero percent for the cost performance category in the final score, and MIPS scoring in 2017 will be determined based on the other three integrated MIPS performance categories. Cost measures do not require reporting of any data by MIPS eligible clinicians to CMS. Although cost measures will not be used to determine the final score in the transition year, we intend to calculate performance on certain cost measures and give this information in performance feedback to clinicians. We intend to calculate measures of total per capita costs for all attributed beneficiaries and a Medicare Spending per Beneficiary (MSPB) measure. In addition, we are finalizing 10 episode-based measures that were previously made available to clinicians in feedback reports and met standards for reliability. Starting in performance year 2018, as performance feedback is available on at least an annual basis, the cost performance category contribution to the final score will gradually increase from 0 to the 30 percent level required
We are finalizing standards for measures, scoring, and reporting for MIPS eligible clinicians across all four performance categories outlined in this section II.E.5.h of this final rule with comment period. Beginning in 2017, some APMs, by virtue of their structure, will not meet statutory requirements to be categorized as Advanced APMs. Eligible clinicians in these APMs, hereafter referred to as MIPS APMs, will be subject to MIPS reporting requirements and the MIPS payment adjustment. In addition, eligible clinicians who are in Advanced APMs but do not meet participation thresholds to be excluded from MIPS for a year will be subject to the scoring standards for MIPS reporting requirements and the MIPS payment adjustment. In response to comments, in an effort to recognize these eligible clinicians' participation in delivery system reform and to avoid potential duplication or conflicts between these APMs and MIPS, we finalize an APM scoring standard that is different from the generally applicable standard. We finalize our proposal that MIPS eligible clinicians who participate in MIPS APMs will be scored using the APM scoring standard instead of the generally applicable MIPS scoring standard.
We are finalizing that MIPS eligible clinicians have the flexibility to submit information individually or via a group or an APM Entity group; however, the MIPS eligible clinician will use the same identifier for all performance categories. The finalized scoring methodology has a unified approach across all performance categories, which will help MIPS eligible clinicians understand in advance what they need to do in order to perform well in MIPS. The three performance category scores (quality, improvement activities, and advancing care information) will be aggregated into a final score. The final score will be compared against a MIPS performance threshold of 3 points. The final score will be used to determine whether a MIPS eligible clinician receives an upward MIPS payment adjustment, no MIPS payment adjustment, or a downward MIPS payment adjustment as appropriate. Upward MIPS payment adjustments may be scaled for budget neutrality, as required by MACRA. The final score will also be used to determine whether a MIPS eligible clinician qualifies for an additional positive adjustment factor for exceptional performance. The performance threshold will be set at 3 points for the transition year, such that clinicians engaged in the program who successfully report one quality measure can avoid a downward adjustment. MIPS eligible clinicians submitting additional data for one or more of the three performance categories for at least a full 90-day period may quality for varying levels of positive adjustments.
In future years of the program, we will require longer performance periods and higher performance in order to avoid a negative MIPS payment adjustment.
We are finalizing a process for providing performance feedback to MIPS eligible clinicians. Initially, we will provide performance feedback on an annual basis. In future years, we aim to provide performance feedback on a more frequent basis, as well as providing feedback on the performance categories of improvement activities and advancing care information in line with clinician requests for timely, actionable feedback that they can use to improve care. We are finalizing our proposal to make performance feedback available using a web-based application. Further, we are finalizing our proposal to leverage additional mechanisms such as health IT vendors and registries to help disseminate data contained in the performance feedback to MIPS eligible clinicians where applicable.
We are finalizing a targeted review process under MIPS wherein a MIPS eligible clinician may request that we review the calculation of the MIPS payment adjustment factor and, as applicable, the calculation of the additional MIPS payment adjustment factor applicable to such MIPS eligible clinician for a year.
We are finalizing requirements for third party data submission to MIPS that are intended to decrease burden to individual clinicians. Specifically, qualified registries, QCDRs, health IT vendors, and CMS-approved survey vendors will have the ability to act as intermediaries on behalf of MIPS eligible clinicians and groups for submission of data to CMS across the quality, improvement activities, and advancing care information performance categories.
We are finalizing a process for public reporting of MIPS information through the Physician Compare Web site, with the intention of promoting fairness and transparency. We are finalizing public reporting of a MIPS eligible clinician's data; for each program year, we will post on a public Web site, in an easily understandable format, information regarding the performance of MIPS eligible clinicians or groups under MIPS.
We estimate that approximately 70,000 to 120,000 clinicians will become QPs in 2017 and approximately 125,000 to 250,000 clinicians will become QPs in 2018 through participation in Advanced APMs; they are estimated to receive between $333 million and $571 million in APM Incentive Payments for CY 2019. As with MIPS, we expect that APM participation will drive quality improvement for clinical care provided to Medicare beneficiaries and to all patients in the health care system.
Under the policies finalized in this rule, we estimate that, between approximately 592,000 and 642,000 eligible clinicians will be required to participate in MIPS in its transition year. In 2019, MIPS payment adjustments will be applied based on MIPS eligible clinicians' performance on specified measures and activities within three integrated performance categories; the fourth category of cost, as previously outlined, will be weighted to zero in the transition year. Assuming that 90 percent of eligible clinicians of all practice sizes participate in the program, we estimate that MIPS payment adjustments will be approximately equally distributed between negative MIPS payment adjustments ($199 million) and positive MIPS payment adjustments ($199 million) to MIPS eligible clinicians, to ensure budget neutrality. Positive MIPS payment adjustments will also include an additional $500 million for exceptional performance payments to MIPS eligible clinicians whose performance meets or exceeds a threshold final score of 70. These MIPS payment adjustments are expected to drive quality improvement in the provision of MIPS eligible clinicians' care to Medicare beneficiaries and to all patients in the health care system. However, the distribution could change based on the final population of MIPS eligible clinicians for CY 2019 and the distribution of scores under the program. We believe that starting with these modest initial MIPS payment adjustments, representing less than 0.2 percent of Medicare expenditures for physician and clinical services, is in the long-term best interest of maximizing
In January 2015, the Administration announced new goals for transforming Medicare by moving away from traditional FFS payments in Medicare towards a payment system focused on linking physician reimbursements to quality care through APMs (
The Affordable Care Act includes a number of provisions, for example, the Medicare Shared Savings Program, designed to improve the quality of Medicare services, support innovation and the establishment of new payment models, better align Medicare payments with health care provider costs, strengthen Medicare program integrity, and put Medicare on a firmer financial footing.
The Affordable Care Act created the Center for Medicare and Medicaid Innovation (Innovation Center). The Innovation Center was established by section 1115A of the Act (as added by section 3021 of the Affordable Care Act). The Innovation Center's mandate gives it flexibility within the parameters of section 1115A of the Act to select and test promising innovative payment and service delivery models. The Congress created the Innovation Center for the purpose of testing innovative payment and service delivery models to reduce program expenditures while preserving or enhancing the quality of care provided to those individuals who receive Medicare, Medicaid, or CHIP benefits. See
The Innovation Center's portfolio of models has attracted participation from a broad array of health care providers, states, payers, and other stakeholders, and serves Medicare, Medicaid, and CHIP beneficiaries in all 50 states, the District of Columbia, and Puerto Rico. We estimate that over 4.7 million Medicare, Medicaid, and CHIP beneficiaries are or soon will be receiving care furnished by the more than 61,000 eligible clinicians currently participating in models tested by the CMS Innovation Center.
Beyond the care improvements for these beneficiaries, the Innovation Center models are affecting millions of additional Americans by engaging thousands of other health care providers, payers, and states in model tests and through quality improvement efforts across the country. Many payers other than CMS have implemented alternative payment arrangements or models, or have collaborated in the Innovation Center models. The participation of multiple payers in alternative delivery and payment models increases momentum for delivery system transformation and encourages efficiency for health care organizations.
The Innovation Center works directly with other CMS components and colleagues throughout the federal government in developing and testing new payment and service delivery models. Other federal agencies with which the Innovation Center has collaborated include the Centers for Disease Control and Prevention (CDC), Health Resources and Services Administration (HRSA), Agency for Healthcare Research and Quality (AHRQ), Office of the National Coordinator for Health Information Technology (ONC), Administration for Community Living (ACL), Department of Housing and Urban Development (HUD), Administration for Children and Families (ACF), and the Substance Abuse and Mental Health Services Administration (SAMHSA). These collaborations help the Innovation Center effectively test new models and execute mandated demonstrations.
In developing this final rule with comment period, we sought feedback from stakeholders and the public throughout the process such as in the 2016 Medicare PFS Proposed Rule; the Request for Information Regarding Implementation of the Merit-based Incentive Payment System, Promotion of Alternative Payment Models, and Incentive Payments for Participation in Eligible Alternative Payment Models (hereafter referred to as the MIPS and APMs RFI); listening sessions; conversations with a wide number of stakeholders; and consultation with tribes and tribal officials through an All Tribes' Call on May 19, 2016 and several conversations with the CMS' Tribal Technical Advisory Group. Through the MIPS and APMs RFI published in the
In response to both the RFI and the proposed rule, we received a high degree of interest from a broad spectrum of stakeholders. We thank our many commenters and acknowledge their valued input throughout the proposed rule process. We discuss and respond to the substance of relevant comments in the appropriate sections of this final rule with comment period. In general, commenters continue to support establishment of the Quality Payment Program and maintain optimism as we
In several cases, commenters made suggestions for changes that we considered and ultimately found to be inconsistent with the statute. In keeping with our objectives of maintaining transparency in the program, we outline in the appropriate sections of the rule suggestions from commenters that were considered but found to be inconsistent with the statute.
Commenters have many concerns about their ability to participate effectively in MIPS in 2017 and the program's impacts on small practices, rural practitioners, and various specialty practitioner types. We have attempted to address these concerns by including transitional policies and additional flexibility in relevant sections of the final rule with comment period to encourage participation by all eligible clinicians and practitioner types, and avoid undue impact on any particular group.
Commenters present substantial enthusiasm for broadening opportunities to participate in APMs and the development of new Advanced APMs. Commenters suggest a number of resources should be made available to assist them in moving towards participation in APMs and have submitted numerous proposals for enhancing the APM portfolio and shortening the development process for new APMs. In particular, commenters urged us to modify existing Innovation Center models so they can be classified as Advanced APMs. We appreciate commenters' eagerness to participate in Advanced APMs and to be a part of transforming care. While not within the scope of this rule, we note that CMS has developed in conjunction with this rule a new strategic vision for the development of Advanced APMs over the coming years that will provide significantly enhanced opportunities for clinicians to participate in the program. We thank stakeholders again for their considered responses throughout our process, in various venues, including comments to the MIPS and APMs RFI and the proposed rule. We intend to continue open communication with stakeholders, including consultation with tribes and tribal officials, on an ongoing basis as we develop the Quality Payment Program in future years.
Section 1848(q) of the Act, as added by section 101(c) of the MACRA, requires establishment of MIPS. Section 101(e) of the MACRA promotes the development of, and participation in, Advanced APMs for eligible clinicians.
Through the implementation of the Quality Payment Program, we strive to continue to support health care quality, efficiency, and patient safety. MIPS promotes better care, healthier people, and smarter spending by evaluating MIPS eligible clinicians using a final score that incorporates MIPS eligible clinicians' performance on quality, cost, improvement activities, and advancing care information. Under the incentives for participation in Advanced APMs, our goals, described in greater detail in section II.F of this final rule with comment period, are to expand the opportunities for participation in both APMs and Advanced APMs, improve care quality and reduce health care costs in current and future Advanced APMs, create clear and attainable standards for incentives, promote the continued flexibility in the design of APMs, and support multi-payer initiatives across the health care market. The Quality Payment Program is designed to encourage eligible clinicians to participate in Advanced APMs. The APM Incentive Payment will be available to eligible clinicians who qualify as QPs through Advanced APMs. MIPS eligible clinicians participating in APMs (who do not qualify as QPs) will receive favorable scoring under certain MIPS categories.
Our strategic objectives in developing the Quality Payment Program include: (1) Improve beneficiary outcomes through patient-centered MIPS and APM policy development and patient engagement and achieve smarter spending through strong incentives to provide the right care at the right time; (2) enhance clinician experience through flexible and transparent program design and interactions with exceptional program tools; (3) increase the availability and adoption of alternative payment models; (4) promote program understanding and participation through customized communication, education, outreach and support; (5) improve data and information sharing to provide accurate, timely, and actionable feedback to clinicians and other stakeholders; (6) deliver IT systems capabilities that meet the needs of users and are seamless, efficient and valuable on the front- and back-end; and (7) ensure operational excellence in program implementation and ongoing development.
Section 101(b) of the MACRA calls for the sunsetting of payment adjustments under three existing programs for Medicare enrolled physicians and other practitioners:
• The PQRS that incentivizes EPs to report on quality measures;
• The VM that provides for budget neutral, differential payment adjustment for EPs in physician groups and solo practices based on quality of care compared to cost; and
• The Medicare EHR Incentive Program for EPs that entails meeting certain requirements for the use of CEHRT.
Accordingly, we are finalizing revisions to certain regulations
Similarly, for the Medicare EHR Incentive Program for EPs we are amending § 495.102(d) to remove references to the payment adjustment percentage for years after the 2018 payment adjustment year and add a terminal limit of the 2018 payment adjustment year.
We did not make changes to 42 CFR part 414, subpart N—Value-Based Payment Modifier Under the PFS (§§ 414.1200 through 414.1285). These regulations are already limited to certain years.
The following is a summary of the comments we received regarding sunsetting current payment adjustment programs:
We plan to provide additional educational materials so that clinicians can easily understand the timelines and requirements for the existing and the new programs.
Based on the comments received we are finalizing the revision to PQRS at § 414.90(e) introductory text and § 414.90(e)(1)(ii) and to the Medicare EHR Incentive Program at § 495.102(d) as proposed.
We proposed to require EPs, eligible hospitals, and CAHs to attest (as part of their demonstration of meaningful use under the Medicare and Medicaid EHR Incentive Programs) that they have cooperated with the surveillance and direct review of certified EHR technology under the ONC Health IT Certification Program, as authorized by 45 CFR part 170, subpart E. Similarly, we proposed to require such an attestation from all eligible clinicians under the advancing care information performance category of MIPS, including eligible clinicians who report on the advancing care information performance category as part of an APM Entity group under the APM scoring standard.
As we note below, it is our intent to support MIPS eligible clinicians, eligible clinicians part of an APM Entity, EPs, eligible hospitals, and CAHs' (hereafter collectively referred to in this section as “health care providers”) participation in health IT surveillance and direct review activities. While cooperating with these activities may require prioritizing limited time and other resources, we note that ONC will work with health care providers to accommodate their schedules and consider other circumstances (80 FR 62715). Additionally, ONC has established certain safeguards that can minimize potential burden on health care providers in the event that they are asked to cooperate with the surveillance of their certified EHR technology. Examples of these safeguards, which we described in the proposed rule (81 FR 28171), include: (1) Requiring ONC-Authorized Certification Bodies (ONC-ACBs) to use consistent, objective, valid, and reliable methods when selecting locations at which to perform randomized surveillance of certified health IT (80 FR 62715); (2) allowing ONC-ACBs to use appropriate sampling methodologies to minimize disruption to any individual provider or class of providers and to maximize the value and impact of ONC-ACB surveillance activities for all providers and stakeholders (80 FR 62715); and (3) allowing ONC-ACBs to excuse a health care provider from surveillance and select a different health care provider under certain circumstances (80 FR 62716).
As background to this proposal, we noted that on October 16, 2015, ONC published the 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications final rule (“2015 Edition final rule”). The 2015 Edition final rule made changes to the ONC Health IT Certification Program that enhance the testing, certification, and surveillance of health IT. Importantly, the rule strengthened requirements for the ongoing surveillance of certified EHR technology and other health IT certified on behalf of ONC. Under these requirements established by the 2015 Edition final rule, ONC-ACBs are required to conduct more frequent and more rigorous surveillance of certified technology and capabilities “in the field” (80 FR 62707).
The purpose of in-the-field surveillance is to provide greater assurance that health IT meets certification requirements not only in a controlled testing environment, but also when used by health care providers in actual production environments (80 FR 62707). In-the-field surveillance can take two forms: First, ONC-ACBs conduct “reactive surveillance” in response to complaints or other indications that certified health IT may not conform to the requirements of its certification (45 CFR 170.556(b)). Second, ONC-ACBs carry out ongoing “randomized surveillance” based on a randomized sample of all certified Complete EHRs and Health IT Modules to assess certified capabilities and other requirements prioritized by the National Coordinator (45 CFR 170.556(c)). Consistent with the purpose of ONC-ACB surveillance—which is to verify that certified health IT performs in accordance with the requirements of its certification when it is implemented and used in the field—an ONC-ACB's assessment of a certified capability must be based on the use of the capability in the live production environment in which the capability has been implemented and is in use (45 CFR
On October 19, 2016, ONC will publish the ONC Enhanced Oversight and Accountability final rule, which enhances oversight under the ONC Health IT Certification Program by establishing processes to facilitate ONC's direct review and evaluation of the performance of certified health IT in certain circumstances, including in response to problems or issues that could pose serious risks to public health or safety (see the October 19, 2016
When carrying out ONC-ACB surveillance or ONC direct review, ONC-ACBs and/or ONC may request that health care providers supply information (for example, by way of telephone inquiries or written surveys) about the performance of the certified EHR technology capabilities the provider possesses and, when necessary, may request access to the provider's certified EHR technology (and data stored in such certified EHR technology) to confirm that capabilities certified by the developer are functioning appropriately. Health care providers may also be asked to demonstrate capabilities and other aspects of the technology that are the focus of such efforts.
In the Quality Payment Program proposed rule, we explained that these efforts to strengthen surveillance and direct review of certified health IT are critical to the success of HHS programs and initiatives that require the use of certified health IT to improve health care quality and the efficient delivery of care. We explained that effective ONC-ACB surveillance and ONC direct review is fundamental to providing basic confidence that the certified health IT used under the HHS programs consistently meets applicable standards, implementation specifications, and certification criteria adopted by the Secretary when it is used by health care providers, as well as by other persons with whom health care providers need to exchange electronic health information to comply with program requirements. In particular, the need to ensure that certified health IT consistently meets applicable standards, implementation specifications, and certification criteria is important both at the time the technology is certified (by meeting the requirements for certification in a controlled testing environment) and on an ongoing basis to ensure that the technology continues to meet certification requirements when it is actually implemented and used by health care providers in real-world production environments. We explained that efforts to strengthen surveillance and direct review of certified EHR technology in the field will become even more important as the types and capabilities of certified EHR technology continue to evolve and with the onset of Stage 3 of the Medicare and Medicaid EHR Incentive Programs and MIPS, which include heightened requirements for sharing electronic health information with other providers and with patients. Finally, we noted that effective surveillance and direct review of certified EHR technology is necessary if health care providers are to be able to rely on certifications issued under the ONC Health IT Certification Program as the basis for selecting appropriate technologies and capabilities that support the use of certified EHR technology while avoiding potential implementation and performance issues (81 FR 28170-28171).
For all of these reasons, the effective surveillance and direct review of certified health IT, and certified EHR technology as it applies to providers covered by this provision, provide greater assurance to health care providers that their certified EHR technology will perform in a manner that meets their expectations and that will enable them to demonstrate that they are using certified EHR technology in a meaningful manner as required by sections 1848(o)(2)(A)(i) and 1886(n)(3)(A)(i) of the Act. We stressed in the proposed rule (81 FR 28170-28171), however, that such surveillance and direct review will not be effective unless health care providers are actively engaged and cooperate with these activities, including by granting access to and assisting ONC-ACBs and ONC to observe the performance of production systems (
Accordingly, we proposed that as part of demonstrating the use of certified EHR technology in a meaningful manner, a health care provider must demonstrate its good faith cooperation with authorized surveillance and direct review. We proposed to revise the definition of a meaningful EHR user at § 495.4 as well as the attestation requirements at § 495.40(a)(2)(i)(H) and § 495.40(b)(2)(i)(H) to require EPs, eligible hospitals, and CAHs to attest their cooperation with certain authorized health IT surveillance and direct review activities as part of demonstrating meaningful use under the Medicare and Medicaid EHR Incentive Programs. Similarly, we proposed to include an identical attestation requirement in the submission requirements for MIPS eligible clinicians under the advancing care information performance category proposed at § 414.1375.
We proposed that health care providers would be required to attest that they have cooperated in good faith with the authorized ONC-ACB surveillance and ONC direct review of their health IT certified under the ONC Health IT Certification Program, as authorized by 45 CFR part 170, subpart E, to the extent that such technology meets (or can be used to meet) the definition of CEHRT. Under the terms of the attestation, we stated that such cooperation would include responding in a timely manner and in good faith to requests for information (for example, telephone inquiries and written surveys) about the performance of the certified EHR technology capabilities in use by the provider in the field (81 FR 28170 through 28171). It would also include accommodating requests (from ONC-ACBs or from ONC) for access to the provider's certified EHR technology (and data stored in such certified EHR technology) as deployed by the health care provider in its production environment, for the purpose of carrying out authorized surveillance or direct review, and to demonstrate capabilities and other aspects of the technology that are the focus of such efforts, to the extent that doing so would not compromise patient care or be unduly burdensome for the health care provider.
We stated that the proposed attestation would support providers in meeting the requirements for the meaningful use of certified EHR technology while at the same time minimizing burdens for health care providers and patients (81 FR 28170 through 28171). We requested public comment on this proposal.
Through public forums, listening sessions, and correspondence received by CMS and ONC, and through the methods available for health care providers to submit
As we have explained, our proposal to require that health care providers cooperate with ONC-ACB surveillance of certified health IT and ONC direct review of certified health IT reflects the need to address technical issues with the functionality of certified EHR technology and to support health care providers with the performance of their certified EHR technology. By cooperating with these activities, health care providers would assist ONC-ACBs and ONC in working with health IT developers to identify and rectify problems and issues with their technology. In addition, a health care provider who assists an ONC-ACB or ONC with these activities is also indirectly supporting other health care providers, interoperability goals, and the health IT infrastructure by helping to ensure the integrity and efficacy of certified health IT products in health care settings. To more clearly and accurately communicate the context and role of health care providers in these activities, and consistent with our approach to clarifying terminology and references, we have adopted new terminology in this final rule with comment period that focuses on the requirements for the health care provider rather than ONC or ONC-ACB actions and processes. In this section, the activities to be engaged in by health care providers in cooperation with ONC direct review or ONC-ACB surveillance are intended to support health care providers with the performance of certified EHR technology. We therefore use the phrase “Supporting Providers with the Performance of Certified EHR technology activities” (hereinafter referred to as “SPPC activities”) to refer to a health care provider's actions related to cooperating in good faith with ONC-ACB authorized surveillance and, separately or collectively as the context requires, a health care provider's actions in cooperating in good faith with ONC direct review.
Notwithstanding the terminology used in this final rule with comment period, and to avoid any confusion for health care providers engaging with ONC-ACBs or ONC in the future, we note that, when communicating with health care providers about the surveillance or direct review of certified health IT, ONC-ACBs and ONC will use the terminology in the 2015 Edition final rule, the ONC Enhanced Oversight and Accountability final rule, or other relevant ONC rulemakings and regulations, if applicable. In particular, a request for cooperation made by an ONC-ACB to a health care provider will not refer to “SPPC activities.” Rather, the request will typically refer to the ONC-ACB's need to carry out “surveillance” of the certified health IT used by the health care provider. Similarly, if ONC requests the cooperation of a health care provider in connection with ONC's direct review of certified health IT, as described in the ONC Enhanced Oversight and Accountability final rule scheduled for publication in the
We received public comment on the proposals and our response follows.
Commenters offered a number of suggestions to reduce the potential burden of this proposal on health care providers. First, some commenters strongly endorsed the safeguards established by ONC—including methods used to select locations, such as sampling and weighting considerations and the exclusion of certain locations in appropriate circumstances. In addition, one commenter recommended that, where ONC-ACB surveillance or ONC direct review involves evaluating certified EHR technology in the field, the ONC-ACB surveillance or ONC direct review should be scheduled 30 days in advance and at a time that is convenient to accommodate the health care providers' schedules, such as after hours or on weekends. The commenter suggested that this would avoid disruption both to administrative operations and patient care.
We also understand the concerns expressed by some commenters that engaging in SPPC activities should not unreasonably disrupt the workflow or operations of a health care provider. In consultation with ONC, we expect that in most cases ONC and ONC-ACBs will accommodate providers' schedules and other circumstances, and that in most cases providers will be given ample notice of and time to respond to requests from ONC and ONC-ACBs. We note that in some cases it may be necessary to secure a health care provider's cooperation relatively quickly, such as if a potential problem or issue with certified EHR technology poses potentially serious risks to public health or safety (see the ONC Enhanced Oversight and Accountability final rule scheduled for publication in the
Finally, through public comment on the proposed rule, we note that in addition to these specific concerns expressed and addressed regarding SPPC activities, stakeholders share a general concern over the risks and potential negative impact of transitioning to MIPS and upgrading certified health IT in a short time without adequate preparation and support. Stakeholders are particularly concerned about this impact on solo practitioners, small practices, and health care providers with limited resources that may be providing vital access to health care in under-served communities. As noted previously, we believe the safeguards and policies established for ONC-ACBs' activities, discussed above, mitigate the risk of disruption to health care providers under normal circumstances. However, consistent with our overall approach for implementing new programs and requirements such as the Quality Payment Program and historically under the EHR Incentive Programs, we are modifying our final policy from the proposal to allow for additional flexibility for health care providers.
Our proposed policy would require health care providers to attest that they cooperated in good faith with ONC-ACB surveillance and ONC's direct review of certified health IT in order to demonstrate they have used certified EHR technology in a meaningful manner. In this final rule with comment period, we are finalizing a modified approach that splits the SPPC activities into two parts and draws a distinction between cooperation with ONC direct review and cooperation with ONC-ACB surveillance requests.
We are finalizing as proposed the requirement to cooperate in good faith with a request relating to ONC direct review of certified health IT. We do not believe it is appropriate to modify this requirement because ONC direct review is designed to mitigate potentially serious risk to public health and safety and to address practical challenges in reviewing certified health IT by an ONC-ACB. However, we are finalizing a modification to the requirement to cooperate with a request relating to ONC-ACB surveillance, which is different from ONC direct review (see discussion above). The modification to ONC-ACB surveillance will allow providers to choose whether to participate in SPPC activities supporting ONC-ACB surveillance of certified EHR technology.
As described in this section, ONC direct review focuses on situations involving (1) public health and safety and (2) practical challenges for ONC-ACBs, such as when a situation exceeds an ONC-ACB's resources or expertise. We maintain that cooperation in ONC direct review, when applicable, is important to demonstrating that a health care provider used certified EHR technology in a meaningful manner as required by sections 1848(o)(2)(A)(i) and 1886(n)(3)(A)(i) of the Act as stated in the proposed rule (81 FR 28170 through 28171).
We are therefore finalizing a two part attestation that splits the SPPC activities. As it relates to ONC direct review, the attestation is required. As it relates to ONC-ACB surveillance, the attestation is optional. The attestations are as follows:
• Health care providers must attest that they engaged in good faith in SPPC activities related to ONC direct review by: (1) Attesting their acknowledgment of the requirement to cooperate in good faith with ONC direct review of their health information technology certified under the ONC Health IT Certification Program if a request to assist in ONC direct review is received; and (2) if a request is received, attesting that they cooperated in good faith in ONC direct review of health IT under the ONC Health IT Certification Program to the extent that such technology meets (or can be used to meet) the definition of certified EHR technology.
• Optionally, health care providers may attest that they engaged in good faith in SPPC activities related to ONC-ACB surveillance by: (1) Attesting their acknowledgement of the option to cooperate in good faith with ONC-ACB surveillance of their health information technology certified under the ONC Health IT Certification Program if a request to assist in ONC-ACB surveillance is received; and (2) if a request is received, attesting that they cooperated in good faith in ONC-ACB surveillance of health IT under the ONC Health IT Certification Program, to the extent that such technology meets (or can be used to meet) the definition of certified EHR technology.
As noted previously, only a small percentage of providers are likely to receive a request for assistance from ONC or an ONC-ACB in a given year. Therefore under this final policy, for both the mandatory attestation and for the optional attestation, a health care provider is considered to be engaging in SPPC activities related to supporting providers with the performance of certified EHR technology first by an attestation of acknowledgment of the policy and second by an attestation of cooperation in good faith if a request to assist was received from ONC or an ONC-ACB. However, we reiterate that the attestation requirement as it pertains to cooperation with ONC-ACB surveillance is optional for health care providers.
Operationally, we expect that the submission method selected by the health care provider will influence how these attestations are accomplished (
A health care provider electronically submitting data for MIPS would be required to use the form and manner specified for the submission mechanism to indicate their attestation to the first part, and may indicate their attestation to the second part if they so choose. CMS and ONC will also offer continued support and guidance both through educational resources to support participating in and reporting to CMS programs, and through specific guidance for those health care providers who receive requests related to engaging in SPPC activities.
Several commenters stated that health care providers should not be required to cooperate with on-premises observation of their certified EHR technology because an ONC-ACB should be able to access and evaluate the performance of certified health IT capabilities using remote access methods. By contrast, other commenters stated that remote observation could create security risks and that all observations should be conducted on the premises, preferably under the direction of the health care provider's clinical staff.
We decline to limit health care providers' engagement in SPPC activities to any particular form of observation, such as on-premises or remote observation of certified capabilities. We note that in the 2015 Edition final rule, ONC explained the observation of certified health IT capabilities in a production environment may require a variety of methodologies and approaches (80 FR 62709). In addition, as the comments suggest, individual health care providers are likely to have different preferences and should have the flexibility to work with an ONC-ACB or ONC to identify an approach to these activities that is most effective and convenient. In this connection, we have consulted with ONC and expect that, where feasible, a health care provider's preference for a particular form of observation will be accommodated.
For similar reasons, we decline to limit engagement in SPPC activities to the use of test systems or test data. The use of test systems and test data may be allowed in some circumstances, but may not be appropriate in all circumstances. For example, a problem with certified EHR technology capabilities may be difficult or impossible to replicate with test systems or test data. More fundamentally, limiting cooperation to observations of test systems and test data may not provide the same degree of assurance that certified EHR technology used by health care providers (for example, production systems used with production data) continue to meet applicable certification requirements and function in a manner that supports health care providers participation in the EHR Incentive Programs and MIPS.
We disagree with commenters who maintained that the disclosure of PHI to ONC or an ONC-ACB could be inconsistent with reasonable privacy or other organizational policies or would otherwise be an unjustified invasion of privacy or any other interest. As noted, the disclosure of this information would be authorized by law on the basis that it is a disclosure to a health oversight agency (ONC) for the purpose of determining compliance with a federal program (the ONC Health IT Certification Program). In addition, we note that any further disclosure of PHI by an ONC-ACB or ONC would be limited to disclosures authorized by law, such as under the federal Privacy Act of 1974, or the Freedom of Information Act (FOIA), as applicable.
As program guidance is developed, CMS and ONC will work to ensure that requests from ONC and ONC-ACBs provide clear context and guidance for health care providers when requesting that health care providers engage in SPPC activities as part of their participation in CMS programs.
Because assistance with ONC-ACB surveillance or ONC direct review will typically be carried out at a practice or facility level, we expect that it will be rare for a health care provider to be directly involved in the conduct of many of these activities, including in-the-field observations of certified EHR technology capabilities. To comply with the attestation requirements, a health care provider should establish to their own satisfaction that appropriate processes and policies are in place in their practice to ensure that all relevant personnel, such as a practice manager or IT officer, are aware of the health care provider's obligation to engage in SPPC activities related to requests to assist in ONC direct review of certified health IT and the health care provider's option to engage in SPPC activities related to requests to assist in ONC-ACB surveillance of certified health IT. This includes understanding the requirement to cooperate in good faith with a request to assist in ONC direct review if received. Health care providers should also ensure that appropriate processes and policies are in place for the practice to document all requests and communications concerning SPPC activities as they would for other requirements of CMS programs in which they participate. We note that for a health care provider participating in a CMS program as an individual, if that health care provider practices at multiple locations or switches locations throughout the course of a year, they would only need to make inquiries about any requests to assist in ONC direct review of certified health IT during the period in which the eligible clinician or EP worked at the practice.
We acknowledge the commenter's desire for a checklist tool to provide greater certainty for clinicians. However, as ONC explained in the 2015 Edition final rule, an evaluation of certified health IT in a production environment may require a variety of methodologies and approaches (80 FR 62709) and individual health care providers are able to express different preferences and should have the flexibility to work with ONC or an ONC-ACB to identify an effective approach that is most convenient. Because the specific actions required will be addressed on a case-by-case basis, the development of a checklist tool may not be feasible. Rather, as noted previously, if any request is made, ONC or an ONC-ACB will work directly with the health care provider to provide clear guidance on the actions needed to assist in the request. The health care provider would then retain any such documentation concerning the request for their records as they would for other similar requirements in CMS programs.
After review and consideration of public comment, we are finalizing revisions to the definition of a meaningful EHR user at §§ 495.4 and 414.1305 to include “engaging in activities related to supporting providers with the performance of certified EHR technology.”
We are finalizing modifications to the attestation requirements at § 495.40(a)(2)(i)(H) and (b)(2)(i)(H) to require an EP, eligible hospital or CAH to attest that they engaged in SPPC activities by attesting that they: (1) Acknowledge the requirement to cooperate in good faith with ONC direct review of their health information technology certified under the ONC Health IT Certification Program if a request to assist in ONC direct review is received; and (2) if requested, cooperated in good faith with ONC direct review of their health information technology certified under the ONC Health IT Certification Program, as authorized by 45 CFR part 170, subpart E, to the extent that such technology meets (or can be used to meet) the definition of CEHRT, including by permitting timely access to such technology and demonstrating its capabilities as implemented and used by the EP, eligible hospital, or CAH in the field.
Additionally, we are finalizing that, optionally, the EP, eligible hospital, or CAH may also attest that they engaged in SPPC activities by attesting that they: (1) Acknowledge the option to cooperate in good faith with ONC-ACB surveillance of their health information technology certified under the ONC Health IT Certification Program if a
We are also finalizing at § 404.1375(3) that the same attestations be made by all eligible clinicians under the advancing care information performance category of MIPS, including eligible clinicians who report on the advancing care information performance category as part of an APM Entity group under the APM scoring standard, as discussed in section II.E.5.h. of this final rule with comment period (
To prevent actions that block the exchange of information, section 106(b)(2)(A) of the MACRA amended section 1848(o)(2)(A)(ii) of the Act to require that, to be a meaningful EHR user, an EP must demonstrate that he or she has not knowingly and willfully taken action (such as to disable functionality) to limit or restrict the compatibility or interoperability of certified EHR technology. Section 106(b)(2)(B) of MACRA made corresponding amendments to section 1886(n)(3)(A)(ii) of the Act for eligible hospitals and, by extension, under section 1814(l)(3) of the Act for CAHs. Sections 106(b)(2)(A) and (B) of the MACRA provide that the manner of this demonstration is to be through a process specified by the Secretary, such as the use of an attestation. Section 106(b)(2)(C) of the MACRA states that the demonstration requirements in these amendments shall apply to meaningful EHR users as of the date that is 1 year after the date of enactment, which would be April 16, 2016.
As legislative background, on December 16, 2014, in an explanatory statement accompanying the Consolidated and Further Continuing Appropriations Act,
We explained in the proposed rule that the demonstration required by section 106(b)(2) of the MACRA must provide substantial assurance not only that certified EHR technology was connected in accordance with applicable standards during the relevant EHR reporting period, but that the health care provider acted in good faith to implement and use the certified EHR technology in a manner that supported and did not interfere with the electronic exchange of health information among health care providers and with patients to improve quality and promote care coordination (81 FR 28172). We proposed that such a demonstration be made through an attestation (referred to in this section of the preamble as the “information blocking attestation”), which would comprise three statements related to health information exchange and information blocking, which were described in the proposed rule (81 FR 28172). Accordingly, we proposed to revise the definition of a meaningful EHR user at § 495.4 and to revise the corresponding attestation requirements at § 495.40(a)(2)(i)(I) and (b)(2)(i)(I) to require this attestation for all EPs, eligible hospitals, and CAHs under the Medicare and Medicaid EHR Incentive Programs, beginning with attestations submitted on or after April 16, 2016. Further, we proposed this attestation requirement (at § 414.1375(b)(3)(ii)) for all eligible clinicians under the advancing care information performance category of MIPS, including eligible clinicians who report on the advancing care information performance category as part of an APM Entity group under the APM scoring standard, as discussed in section II.E.5.h of the proposed rule (81 FR 28181).
We invited public comment on this proposal, including whether the proposed attestation statements could provide the Secretary with adequate assurances that an eligible clinician, EP, eligible hospital, or CAH has complied with the statutory requirements for information exchange. We also encouraged public comment on whether there are additional facts or circumstances to which eligible clinicians, EPs, eligible hospitals, and CAHs should be required to attest, or whether there is additional information that they should be required to report.
Many commenters expressed partial support for this proposal but voiced concerns about the particular content or form of the information blocking attestation as proposed. Several commenters stated that the language of the attestation was unclear and should provide more detail regarding the specific actions health care providers would be required to attest. Conversely, several commenters (including some of the same commenters) believe that the language of the attestation was too prescriptive. Some commenters recommended revising or removing one or more of the three statements that comprise the attestation. A few commenters suggested that we finalize only the first statement—which mirrors the statutory language in section 106(b)(2) of the MACRA—and contended that the other statements were unnecessary or, alternatively, go beyond what section 106(b)(2) requires.
Some commenters were opposed in principle to requiring health care
The majority of commenters, whether they supported or opposed the proposal, stressed that certain factors that prevent interoperability and the ability to successfully exchange and use electronic health information are beyond the ability of a health care provider to control. Many of these commenters stated that EHR vendors should be required to submit an information blocking attestation because they have greater control over these factors and, in the experience of some commenters, are more likely to engage in information blocking.
As many commenters recognized, the information blocking concerns expressed by Congress are serious and reflect a systemic problem: A growing body of evidence establishes that persons and entities—including some health care providers—have strong incentives to unreasonably interfere with the exchange and use of electronic health information, undermining federal programs and investments in the meaningful use of certified EHR technology to improve health and the delivery of care.
The proposed information blocking attestation consists of three statements that contain several specific representations about a health care provider's implementation and use of certified EHR technology. These representations, taken together, will enable the Secretary to infer with reasonable confidence that the attesting health care provider acted in good faith to support the appropriate exchange of electronic health information and therefore did not knowingly and willfully limit or restrict the compatibility or interoperability of certified EHR technology.
We believe that this level of specificity is necessary and that a more generalized attestation would not provide the necessary assurances described above. This does not mean, however, that the information blocking attestation imposes unnecessary or unreasonable requirements on health care providers. To the contrary, we have carefully tailored the attestation to the demonstration required by section 106(b)(2) of the MACRA. In particular, the attestation focuses on whether a health care provider acted in good faith to implement and use certified EHR technology in a manner that supports interoperability and the appropriate exchange of electronic health information. Recognizing that a variety of factors may prevent the exchange or use of electronic health information, and consistent with the focus of section 106(b)(2) on actions that are knowing and willful, this good faith standard takes into account health care providers' individual circumstances and does not hold them accountable for consequences they cannot reasonably influence or control.
For these and the additional reasons set forth in our responses to comments immediately below, and subject to the clarifications therein, we are finalizing this attestation requirement as proposed.
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This statement mirrors the language of section 106(b)(2) of the MACRA. We note that except for one illustrative example (concerning actions to disable functionality), the above statement does not contain specific guidance as to the types of actions that are likely to “limit or restrict” the compatibility or interoperability of certified EHR technology, nor the circumstances in which a health care provider who engages in such actions does so “knowingly and willfully.” The information blocking attestation supplements the foregoing statement with two more detailed statements concerning the specific actions a health care provider took to support interoperability and the exchange of electronic health information.
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This statement focuses on the manner in which a health care provider implemented its certified EHR technology during the relevant reporting period, which is directly relevant to whether the health care provider took any actions to limit or restrict the compatibility or interoperability of the certified EHR technology. By attesting to this statement, a health care provider represents that it acted in good faith to implement its certified EHR technology in a manner that supported—and did not limit or restrict—access to and the exchange of electronic health information, to the extent that such access or exchange was appropriate (that is, practicable under the circumstances and authorized, permitted, or required by law). More specifically, the health care provider represents that it took reasonable steps (including working with its health IT developer and others as necessary) to verify that its certified EHR technology was connected (that is, implemented and configured) in accordance with applicable standards and law.
In addition to verifying that certified EHR technology was connected and accessible during the relevant reporting period, a health care provider must represent that it took reasonable steps to implement corresponding technologies, standards, policies, practices, and agreements to enable the use of certified EHR technology, including by patients and by other health care providers, and not to limit or restrict appropriate access to or use of information in the health care provider's certified EHR technology. For example, actions to limit or restrict compatibility or interoperability could include implementing or configuring certified EHR technology so as to limit access to certain types of data elements or to the “structure” of the data, or implementing certified EHR technology in ways that limit the types of persons or entities that may be able to access and exchange information, or the types of technologies through which they may do so.
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This third and final statement builds on a health care provider's representations concerning the manner in which its certified EHR technology was implemented by focusing on how the health care provider actually
We provide further discussion and analysis of the foregoing statements and their application in our responses to the specific comments summarized in the remainder of this section. We believe that these statements, taken together, provide a clear and appropriately detailed description of a health care provider's obligations under section 106(b)(2) of the MACRA, will enable them to demonstrate compliance to the satisfaction of the Secretary, and will promote fair and consistent application of program requirements across all attesting health care providers.
One commenter suggested that we approach this question in the manner described in the Information Blocking Report, which focuses on whether actions that interfere with the exchange or use of electronic health information have any objectively reasonable justification.
• Contract terms, policies, or other business or organizational practices that restrict individuals' access to their electronic health information or restrict the exchange or use of that information for treatment and other permitted purposes.
• Charging prices or fees that make exchanging and using electronic health information cost prohibitive.
• Implementing certified EHR technology in non-standard ways that are likely to substantially increase the costs, complexity, or burden of sharing electronic health information (especially when relevant interoperability standards have been adopted by the Secretary).
• Implementing certified EHR technology in ways that are likely to “lock in” users or electronic health information (including using certified EHR technology to inappropriately limit or steer referrals).
Such actions would be contrary to section 106(b)(2) only when engaged in “knowingly and willfully.” We believe the purpose of this requirement is to ensure that health care providers are not penalized for actions that are inadvertent or beyond their control.
To illustrate these concepts, we consider several hypothetical scenarios raised by the commenters. First, we consider the situation suggested by one commenter in which a health care provider disables its computer network overnight to perform system maintenance. In this situation, the health care provider knows that the natural and probable consequence of its actions will be to prevent access to information in the certified EHR technology and in this way limit and restrict the interoperability of the technology. However, we recognize that health IT requires maintenance to ensure that capabilities function properly, including in accordance with applicable standards and law. We also appreciate that in many cases it may not be practicable to implement redundant capabilities and systems for all functionality within certified EHR technology, especially for physician practices and other health care providers with comparatively less health IT resources and expertise. Assuming that a health care provider acts in good faith to disable functionality for the purpose of performing system maintenance, it is unlikely that the health care provider would knowingly and willfully limit or restrict the compatibility or interoperability of the certified EHR technology. We note that our assumption that the health care provider acted in good faith presupposes that it did not disable functionality except to the extent and for the duration necessary to ensure the proper maintenance of its certified EHR technology, and that it took reasonable steps to minimize the impact of such maintenance on the ability of patients and other health care providers to appropriately access and exchange information, such as by scheduling maintenance overnight and responding to any requests for access or exchange once the maintenance has been completed and it is otherwise practicable to do so.
Next, we consider the situation in which a health care provider blocks access to information in its certified EHR technology due to concerns related to the security of the information. Depending on the circumstances, certain access restrictions may be reasonable and necessary to protect the security of information maintained in certified EHR technology. In contrast, restrictions that are unnecessary or unreasonably broad could constitute a knowing and willful restriction of the compatibility or interoperability of the certified EHR technology. Because of the complexity of these issues, determining whether a health care provider's actions were reasonable would require additional information about the health care provider's actions and the circumstances in which they took place.
As a final example, we consider whether it would be permissible for a health care provider to restrict access to a patient's sensitive test results until the clinician who ordered the tests, or another designated health care professional, has had an opportunity to review and appropriately communicate the results to the patient. We assume for purposes of this example that, consistent with the HIPAA Privacy Rule, the restriction does not apply to the patient herself or to the patient's request in writing to send this information to any other person the patient designates. With that assumption and under the circumstances we have described, it is likely that the health care provider is knowingly restricting interoperability. We believe that the restriction may be reasonable so long as the health care provider reasonably believes, based on its relationship with the particular patient and its best clinical judgment, that the restriction is necessary to protect the health or wellbeing of the patient. We note that our analysis would be different if the restriction were not based on a health care provider's individualized assessment of the patient's best interests and instead reflected a blanket policy to block access to test results until released by the ordering physician. Similarly, while clinical judgment and the health care provider-patient relationship are entitled to substantial deference, they may not be used as a pretext for limiting or restricting the compatibility or interoperability of certified EHR technology.
The examples provided in this section of the final rule with comment period are intended to be illustrative. We reiterate the need to consider the unique facts and circumstances in each case in order to determine whether a health care provider knowingly and willfully limited or restricted the compatibility or interoperability of certified EHR technology.
Other commenters opposed or raised concerns regarding this aspect of our proposal, stating that bi-directional information exchange may not be feasible for many health care providers or may raise a variety of technical and operational challenges and potential privacy or security concerns.
Some commenters requested that CMS clarify the term “bi-directional exchange” and the actions a health care provider would be expected to take to satisfy this aspect of the attestation. One commenter inquired specifically whether bi-directional exchange could include using a health information exchange or other intermediary to connect disparate certified EHR technology so that users could both send and receive information in an interoperable manner. If so, the commenter asked whether a health care provider would be expected to participate in multiple arrangements of this kind (and, if so, how many). Multiple commenters stated that it is not appropriate to allow bi-directional exchange in all circumstances and that privacy, security, safety, and other considerations require health care providers to restrict the types of information that the certified EHR technology will accept and the persons or other sources of that information.
We expect these trends to increase as standards and technologies improve and as health care providers, especially those participating in Advanced APMs, seek to obtain more complete and accurate information about their patients with which to coordinate care, manage population health, and engage in other efforts to improve quality and value.
We clarify that bi-directional exchange may include using certified EHR technology with a health information exchange or other intermediary to connect disparate certified EHR technology so that users could both send and receive information in an interoperable manner. Whether a health care provider could participate in
A few commenters were concerned that health care providers may be penalized for limiting or restricting access to information despite not knowing whether an unaffiliated health care provider or EHR vendor is authorized or permitted to access a patient's PHI. Another commenter noted that some state laws require written patient consent before certain types of health information may be exchanged electronically. Some commenters contested the technical feasibility of exchanging information with unaffiliated health care providers and across disparate certified EHR technologies, explaining that federally-adopted standards such as the Direct standard do not support such robust information sharing. In particular, there is no widely-accepted and standardized method to encode requests in Direct messages, which means that a receiving system will often be unable to understand what information is being requested.
We recognize that technical, legal, and other practical constraints may prevent a health care provider from responding to some requests to access, exchange, or use electronic health information in a health care provider's certified EHR technology, even when the requester has permission or the right to access and use the information. We reiterate that in these circumstances a health care provider probably would not have knowingly and willfully limited or restricted the compatibility or interoperability of the certified EHR technology. We expect that these technical and other challenges will become less significant over time and that health care providers will be able to respond to requests from an increasing range of health care providers and health IT systems.
In response to the concerns regarding the disclosure of PHI without a business associate agreement, we remind commenters that the HIPAA Privacy Rule expressly permits covered entities to disclose PHI for treatment, payment, and operations. We refer commenters to numerous guidance documents and fact sheets issued by the HHS Office for Civil Rights and ONC on this subject.
We need not contemplate whether health systems or any other class of health care provider is more predisposed to engage in information blocking, because the attestation we are finalizing implements section 106(b)(2) of the MACRA, which extends to all MIPS eligible clinicians, eligible clinicians part of an APM Entity, EPs, eligible hospitals, and CAHs.
For these reasons, many commenters suggested that CMS or ONC to require EHR vendors and other health IT developers to attest to an information blocking attestation or to impose other requirements and penalties on developers to deter them from limiting or restricting the interoperability of certified EHR technology and to encourage them to proactively facilitate the sharing of electronic health information. For example, commenters supported the decertification of EHR vendors that charge excessive fees or engage in other practices that may constitute information blocking.
We note a series of legislative proposals included in the President's Fiscal Year 2017 Budget would prohibit information blocking by health IT developers and others and to provide civil monetary penalties and other remedies to deter this behavior.
After review and consideration of public comment, we are finalizing the attestation requirement as proposed. We are finalizing this requirement for EPs, eligible hospitals, and CAHs under the Medicare and Medicaid EHR Incentive Programs and for eligible clinicians under the advancing care information performance category in MIPS, including eligible clinicians who report on the advancing care information performance category as part of an APM Entity group under the APM scoring standard. We are finalizing this requirement for attestations covering EHR reporting periods and MIPS performance periods beginning on or after January 1, 2017.
We have revised and are finalizing the proposed regulation text accordingly. Specifically, we are finalizing the revisions to the definition of a meaningful EHR user at § 495.4 and we are adding the same to the definition of a meaningful EHR user for MIPS at § 414.1305. We are finalizing the attestation requirements at § 495.40(a)(2)(i)(I) and (b)(2)(i)(I) to require such an attestation from EPs, eligible hospitals, and CAHs as part of their demonstration of meaningful EHR use under the Medicare and Medicaid EHR Incentive Programs. We are also finalizing § 414.1375(b)(3) to require this attestation from all eligible clinicians under the advancing care information performance category of MIPS, including eligible clinicians who report on the advancing care information performance category as part of an APM Entity group under the APM scoring standard as discussed in section II.E.5.h. of this final rule with comment period.
At § 414.1305, in subpart O, we proposed definitions for the following terms:
• Additional performance threshold.
• Advanced Alternative Payment Model (Advanced APM).
• Advanced APM Entity.
• Affiliated practitioner.
• Affiliated practitioner list.
• Alternative Payment Model (APM).
• APM Entity.
• APM Entity group.
• APM Incentive Payment.
• Attestation.
• Attributed beneficiary.
• Attribution-eligible beneficiary.
• Certified Electronic Health Record Technology (CEHRT).
• CMS-approved survey vendor.
• CMS Web Interface.
• Covered professional services.
• Eligible clinician.
• Episode payment model.
• Estimated aggregate payment amounts.
• Final score.
• Group.
• Health Professional Shortage Areas (HPSA).
• High priority measure.
• Hospital-based MIPS eligible clinician.
• Improvement activities.
• Incentive payment base period.
• Low-volume threshold.
• Meaningful EHR user for MIPS.
• Measure benchmark.
• Medicaid APM.
• Medical Home Model.
• Medicaid Medical Home Model.
• Merit-based Incentive Payment System (MIPS).
• MIPS APM.
• MIPS eligible clinician.
• MIPS payment year.
• New Medicare-Enrolled MIPS eligible clinician.
• Non-patient facing MIPS eligible clinician.
• Other Payer Advanced APM.
• Other payer arrangement.
• Partial Qualifying APM Participant (Partial QP).
• Partial QP patient count threshold.
• Partial QP payment amount threshold.
• Participation List.
• Performance category score.
• Performance standards.
• Performance threshold.
• Qualified Clinical Data Registry (QCDR).
• Qualified registry.
• QP patient count threshold.
• QP payment amount threshold.
• QP Performance Period.
• Qualifying APM Participant (QP).
• Rural areas.
• Small practices.
• Threshold Score.
• Topped out non-process measure.
• Topped out process measure.
Some of these terms are new in conjunction with MIPS and APMs, while others are used in existing CMS programs. For the new terms and definitions, we note that some of them have been developed alongside policies of this regulation while others are defined by statute. Specifically, the following terms and definitions were established by the MACRA: APM, Eligible Alternative Payment Entity (which we refer to as an Advanced APM Entity), Composite Performance Score (which we refer to as final score), Eligible professional or EP (which we refer to as an eligible clinician), MIPS Eligible professional or MIPS EP (which we refer to as a MIPS eligible clinician), MIPS adjustment factor (which we refer to as a MIPS payment adjustment factor), additional positive MIPS payment adjustment factor (which we refer to as additional MIPS payment adjustment factor), Qualifying APM Participant, and Partial Qualifying APM Participant.
These terms and definitions are discussed in detail in relevant sections of this final rule with comment period.
We believe a successful MIPS program fully equips clinicians identified as MIPS eligible clinicians with the tools and incentives to focus on improving health care quality, efficiency, and patient safety for all their patients. Under MIPS, MIPS eligible clinicians are incentivized to engage in proven improvement measures and activities that impact patient health and safety and are relevant for their patient population. One of our strategic goals in developing the MIPS program is to advance a program that is meaningful, understandable, and flexible for participating MIPS eligible clinicians. One way we believe this will be accomplished is by minimizing MIPS eligible clinicians' burden. We have made an effort to focus on policies that remove as much administrative burden as possible from MIPS eligible clinicians and their practices while still providing meaningful incentives for high-quality, efficient care. In addition, we hope to balance practice diversity with flexibility to address varied MIPS eligible clinicians' practices. Examples of this flexibility include special consideration for non-patient facing MIPS eligible clinicians, an exclusion from MIPS for eligible clinicians who do not exceed the low-volume threshold, and other proposals discussed below.
Section 1848(q)(1)(C)(i) of the Act, as added by section 101(c)(1) of the MACRA, outlines the general definition of a MIPS eligible clinician for the MIPS program. Specifically, for the first and second year for which MIPS applies to payments (and the performance period for such years) a MIPS eligible clinician is defined as a physician (as defined in section 1861(r) of the Act), a physician assistant, nurse practitioner, clinical nurse specialist (as such terms are defined in section 1861(aa)(5) of the Act), a certified registered nurse anesthetist (as defined in section 1861(bb)(2) of the Act), and a group that includes such professionals. The statute also provides flexibility to specify additional eligible clinicians (as defined in section 1848(k)(3)(B) of the Act) as MIPS eligible clinicians in the third and subsequent years of MIPS. As discussed in the proposed rule (81 FR 28177 through 28178), section 1848(q)(1)(C)(ii) and (v) of the Act specifies several exclusions from the definition of a MIPS eligible clinician, which includes clinicians who are determined to be new Medicare-enrolled eligible clinicians, QPs and Partial QPs, or do not exceeded the low-volume threshold pertaining to the dollar value of billed Medicare Part B allowed charges or Part B-enrolled beneficiary count. In addition, section 1848(q)(1)(A) of the Act requires the Secretary to permit any eligible clinician (as defined in section 1848(k)(3)(B) of the Act) who is not a MIPS eligible clinician the option to volunteer to report on applicable measures and activities under MIPS. Section 1848(q)(1)(C)(vi) of the Act clarifies that a MIPS payment adjustment factor (or additional MIPS payment adjustment factor) will not be applied to an individual who is not a MIPS eligible clinician for a year, even if such individual voluntarily reports measures under MIPS. For purposes of this section of the final rule with comment period, we use the term “MIPS payment adjustment” to refer to the MIPS payment adjustment factor (or additional MIPS payment adjustment factor) as specified in section 1848(q)(1)(C)(vi) of the Act.
To implement the MIPS program we must first establish and define a MIPS eligible clinician in accordance with the statutory definition. We proposed to define a MIPS eligible clinician at § 414.1305 as a physician (as defined in section 1861(r) of the Act), a physician assistant, nurse practitioner, and clinical nurse specialist (as such terms are defined in section 1861(aa)(5) of the Act), a certified registered nurse anesthetist (as defined in section 1861(bb)(2) of the Act), and a group that includes such professionals. In addition, we proposed that QPs and Partial QPs who do not report data under MIPS, low-volume threshold eligible clinicians, and new Medicare-enrolled eligible clinicians as defined at § 414.1305 would be excluded from this definition per the statutory exclusions defined in section 1848(q)(1)(C)(ii) and (v) of the Act. We intend to consider using our authority under section 1848(q)(1)(C)(i)(II) of the Act to expand the definition of a MIPS eligible
Additionally, in accordance with section 1848(q)(1)(A) and (q)(1)(C)(vi) of the Act, we proposed to allow eligible clinicians who are not MIPS eligible clinicians, as defined at proposed § 414.1305, the option to voluntarily report measures and activities for MIPS. We proposed at § 414.1310(d) that those eligible clinicians who are not MIPS eligible clinicians, but who voluntarily report on applicable measures and activities specified under MIPS, would not receive an adjustment under MIPS; however, they would have the opportunity to gain experience in the MIPS program. We were particularly interested in public comments regarding the feasibility and advisability of voluntary reporting in the MIPS program for entities such as RHCs and/or FQHCs, including comments regarding the specific technical issues associated with reporting that are unique to these health care providers. We anticipate some eligible clinicians that will not be MIPS eligible clinicians during the first 2 years of MIPS, such as physical and occupational therapists, clinical social workers, and others that have been reporting quality measures under the PQRS for a number of years, will want to have the ability to continue to report and gain experience under MIPS. We requested comments on these proposals.
The following is a summary of the comments we received regarding our proposed definition of the term MIPS eligible clinician and our proposal to allow eligible clinicians who are not MIPS eligible clinicians the option to voluntarily report measures and activities for MIPS.
In addition, we recognize that under MIPS, there will be more eligible clinicians subject to the requirements of EHR reporting than were previously eligible under the Medicare and/or Medicaid EHR Incentive Program, including hospital-based MIPS eligible clinicians, nurse practitioners, physician assistants, clinical nurse specialists, and certified registered nurse anesthetists. Since many of these non-physician clinicians are not eligible to participate in the Medicare and/or Medicaid EHR Incentive Program, we have little evidence as to whether there are sufficient measures applicable and available to these types of MIPS eligible clinicians under our proposals for the advancing care information performance category. As a result, we have provided additional flexibilities to mitigate negative adjustments for the first performance year (CY 2017) in order to allow hospital-based MIPS eligible clinicians, nurse practitioners, physician assistants, clinical nurse specialists, certified registered nurse anesthetists, and other MIPS eligible clinicians to familiarize themselves with the MIPS program. Section II.E.5.g.(8) of this final rule with comment period describes our final policies regarding the re-weighting of the advancing care information performance category within the final score, in which we would assign a weight of zero when there are not sufficient measures applicable and available.
After consideration of the public comments we received, we are finalizing the following policies. We are
Section 1848(q)(2)(C)(iv) of the Act requires the Secretary, in specifying measures and activities for a performance category, to give consideration to the circumstances of professional types (or subcategories of those types determined by practice characteristics) who typically furnish services that do not involve face-to-face interaction with a patient. To the extent feasible and appropriate, the Secretary may take those circumstances into account and apply alternative measures or activities that fulfill the goals of the applicable performance category to such non-patient facing MIPS eligible clinicians. In carrying out these provisions, we are required to consult with non-patient facing MIPS eligible clinicians.
In addition, section 1848(q)(5)(F) of the Act allows the Secretary to re-weight MIPS performance categories if there are not sufficient measures and activities applicable and available to each type of MIPS eligible clinician. We assume many non-patient facing MIPS eligible clinicians will not have sufficient measures and activities applicable and available to report under the performance categories under MIPS. We refer readers to section II.E.6.b.(2) of this final rule with comment period for the discussion regarding how we addressed performance categories weighting for MIPS eligible clinicians for whom no measures exist in a given category.
To establish policies surrounding non-patient facing MIPS eligible clinicians, we must first define the term “non-patient facing.” Currently, the PQRS, VM, and Medicare EHR Incentive Program include two existing policies for considering whether an EP is providing patient-facing services. To determine, for purposes of PQRS, whether an EP had a “face-to-face” encounter with Medicare patients, we assess whether the EP billed for services under the PFS that are associated with face-to-face encounters, such as whether an EP billed general office visit codes, outpatient visits, and surgical procedures. Under PQRS, if an EP bills for at least one service under the PFS during the performance period that is associated with face-to-face encounters and reports quality measures via claims or registries, then the EP is required to report at least one “cross-cutting” measure. EPs who do not meet these criteria are not required to report a cross-cutting measure. For the purposes of PQRS, telehealth services have not historically been included in the definition of face-to-face encounters. For more information, please see the CY 2016 PFS final rule for these discussions (80 FR 71140).
In the Stage 2 final rule (77 FR 54098 through 54099), the Medicare EHR Incentive Program established a significant hardship exception from the meaningful use payment adjustment under section 1848(a)(7)(A) of the Act for EPs that lack face-to-face interactions with patients and those who lack the need to follow-up with patients. EPs with a primary specialty of anesthesiology, pathology or radiology listed in the Provider Enrollment, Chain, and Ownership System (PECOS) as of 6 months prior to the first day of the payment adjustment year automatically receive this hardship exemption (77 FR 54100). Specialty codes associated with these specialties include 05-Anesthesiology, 22-Pathology, 30-Diagnostic Radiology, 36-Nuclear Medicine, 94-Interventional Radiology. EPs with a different specialty are also able to request this hardship exception through the hardship application process. However, telehealth services could be counted by EPs who choose to include these services within the definition of “seen by the EP” for the purposes of calculating patient encounters with the EHR Incentive Program (77 FR 53982).
In the MIPS and APMs RFI (80 FR 63484), we sought comments on MIPS eligible clinicians that should be considered non-patient facing MIPS eligible clinicians and the criteria we should use to identify these MIPS eligible clinicians. Commenters were split when it came to defining and identifying non-patient facing MIPS eligible clinicians. Many took a specialty-driven approach. Commenters generally did not support use of specialty codes alone, which is the approach used by the Medicare EHR Incentive Program. Commenters indicated that these codes do not necessarily delineate between the same specialists who may or may not have patient-facing interaction. One example is cardiologists who specialize in cardiovascular imaging which is also coded as cardiology. On the other hand, as one commenter mentioned, physicians with specialty codes other than “cardiology” (for example, internal medicine) may perform cardiovascular imaging services. Therefore, using the specialty code for cardiology to identify clinicians who typically do not provide patient-facing services would be both over-inclusive and under-inclusive. Other commenters identified specialty types that they believe should be considered non-patient facing MIPS eligible clinicians. Specific specialty types included radiologists, anesthesiologists, nuclear cardiology or nuclear medicine physicians, and pathologists. Others pointed out that certain MIPS eligible clinicians may be primarily non-patient facing MIPS eligible clinicians even though they practice within a traditionally patient-facing specialty. The MIPS and APMs RFI comments and listening sessions with medical societies representing non-patient facing MIPS eligible clinicians specified radiology/imaging, anesthesiology, nuclear cardiology and oncology, and pathology as inclusive of non-patient facing MIPS eligible clinicians. Commenters noted that roles within specific types of specialties may need to be further delineated between patient-facing and non-patient facing
• Pathologists who may be primarily dedicated to working with local hospitals to identify early indicators related to evolving infectious diseases;
• Radiologists who primarily provide consultative support back to a referring physician or provide image interpretation and diagnosis versus therapy;
• Nuclear medicine physicians who play an indirect role in patient care, for example as a consultant to another physician in proper dose administration; or
• Anesthesiologists who are primarily providing supervision oversight to Certified Registered Nurse Anesthetists.
After reviewing current policies, we proposed to define a non-patient facing MIPS eligible clinician for MIPS at § 414.1305 as an individual MIPS eligible clinician or group that bills 25 or fewer patient-facing encounters during a performance period. We considered a patient-facing encounter as an instance in which the MIPS eligible clinician or group billed for services such as general office visits, outpatient visits, and procedure codes under the PFS. We intend to publish the list of patient-facing encounter codes on a CMS Web site similar to the way we currently publish the list of face-to-face encounter codes for PQRS. This proposal differs from the current PQRS policy in two ways. First, it creates a minimum threshold for the quantity of patient-facing encounters that MIPS eligible clinicians or groups would need to furnish to be considered patient-facing, rather than classifying MIPS eligible clinicians as patient-facing based on a single patient-facing encounter. Second, this proposal includes telehealth services in the definition of patient-facing encounters.
We believed that setting the non-patient facing MIPS eligible clinician threshold for individual MIPS eligible clinician or group at 25 or fewer billed patient-facing encounters during a performance period is appropriate. We selected this threshold based on an analysis of non-patient facing Healthcare Common Procedure Coding System (HCPCS) codes billed by MIPS eligible clinicians. Using these codes and this threshold, we identified approximately one quarter of MIPS eligible clinicians as non-patient facing before MIPS exclusions, such as low-volume and newly-enrolled eligible clinician policies, were applied. The majority of clinicians enrolled in Medicare with specialties such as anesthesiology, nuclear medicine, and pathology were identified as non-patient facing in this analysis. The addition of telehealth to the analysis did not affect the outcome, as it created a less than 0.01 percent change in MIPS eligible clinicians categorized as non-patient facing.
Therefore, the proposed approach allows the definition of non-patient facing MIPS eligible clinicians, to include both MIPS eligible clinicians who practice within specialties traditionally considered non-patient facing, as well as MIPS eligible clinicians who provide occasional patient-facing services that do not represent the bulk of their practices. This definition is also consistent with the statutory requirement that refers to professional types who typically furnish services that do not involve patient-facing interaction with a patient.
In response to the MIPS and APMs RFI, some commenters believed that MIPS eligible clinicians should be defined as non-patient facing MIPS eligible clinicians based on whether their billing indicates they provide face-to-face services. Commenters indicated that the use of specific HCPCS codes in combination with specialty codes, may be a more appropriate way to identify MIPS eligible clinicians that have no patient interaction.
We also proposed to include telehealth services in the definition of patient-facing encounters. Various MIPS eligible clinicians use telehealth services as an innovative way to deliver care to beneficiaries and we believe these services, while not furnished in-person, should be recognized as patient-facing. In addition, Medicare eligible telehealth services substitute for an in-person encounter and meet other site requirements under the PFS as defined at § 410.78.
The proposed addition of the encounter threshold for patient-facing MIPS eligible clinicians was intended to minimize concerns that a MIPS eligible clinician could be misclassified as patient-facing as a result of providing occasional telehealth services that do not represent the bulk of their practice. Finally, we believed that this proposed definition of a non-patient facing MIPS eligible clinician for MIPS could be consistently used throughout the MIPS program to identify those MIPS eligible clinicians for whom certain proposed requirements for patient-facing MIPS eligible clinicians (such as reporting cross-cutting measures) may not be meaningful.
We weighed several options when considering the appropriate definition of non-patient facing MIPS eligible clinicians for MIPS; and some options were similar to those we considered in implementing the Medicare EHR Incentive Program. One option we considered was basing the non-patient facing MIPS eligible clinician's definition on a set percentage of patient-facing encounters, such as 5 to 10 percent, that was tied to the same list of patient-facing encounter codes discussed in this section of this final rule with comment period. Another option we considered was the identification of non-patient facing MIPS eligible clinicians for MIPS only by specialty, which might be a simpler approach. However, we did not consider this approach sufficient for identifying all the possible non-patient facing MIPS eligible clinicians, as some patient-facing MIPS eligible clinicians practice in multi-specialty practices with non-patient facing MIPS eligible clinician's practices with different specialties. We would likely have had to develop a separate process to identify non-patient facing MIPS eligible clinicians in other specialties, whereas maintaining a single definition that is aligned across performance categories is simpler. Many comments from the MIPS and APMs RFI discouraged use of specialty codes alone. Additionally, we believed our proposal would allow us to more accurately identify MIPS eligible clinicians who are non-patient facing by applying a threshold to recognize that a MIPS eligible clinician who furnishes almost exclusively non-patient facing services should be treated as a non-patient facing MIPS eligible clinician despite furnishing a small number of patient-facing services.
In the MIPS and APMs RFI (80 FR 63484), we also requested comments on what types of measures and/or improvement activities (new or from other payment systems) we should use to assess non-patient facing MIPS eligible clinicians' performance and how we should apply the MIPS performance categories to non-patient facing MIPS eligible clinicians. Commenters were split on these subjects. A number of commenters stated that non-patient facing MIPS eligible clinicians should be exempt from specific performance categories under MIPS or should be exempt from MIPS as a whole. Commenters who did not favor exemptions generally suggested that we focus on process measures and work with specialty societies to develop new, more clinically relevant measures for non-patient facing MIPS eligible clinicians.
We took these stakeholder comments into consideration. We note that section 1848(q)(2)(C)(iv) of the Act does not
The following is a summary of the comments we received regarding our proposal that defines non-patient facing MIPS eligible clinicians for MIPS as an individual MIPS eligible clinician or group that bills 25 or fewer patient-facing encounters (including telehealth services) during a performance period.
The initial 12-month segment of the non-patient facing determination period would span from the last 4 months of a calendar year 2 years prior to the performance period followed by the first 8 months of the next calendar year and include a 60-day claims run out, which will allow us to inform eligible clinicians and groups of their non-patient status during the month (December) prior to the start of the performance period. We believe that the initial non-patient facing determination period enables us to make eligibility determinations based on 12 months of data that is as close to the performance period as possible while informing eligible clinicians of their non-patient facing status prior to the performance period. The second 12-month segment of the non-patient facing determination period would span from the last 4 months of a calendar year 1 year prior to the performance period followed by the first 8 months of the performance period in the next calendar year and include a 60-day claims run out, which will allow us to inform additional eligible clinicians and groups of their non-patient status during the performance period.
Thus, for purposes of the 2019 MIPS payment adjustment, we will initially identify individual eligible clinicians and groups who are considered non-patient facing MIPS eligible clinicians based on 12 months of data starting from September 1, 2015 to August 31, 2016. In order to account for the identification of additional individual eligible clinicians and groups that may qualify as non-patient facing during the 2017 performance period, we will conduct another eligibility determination analysis based on 12 months of data starting from September 1, 2016 to August 31, 2017.
In regard to the comment pertaining to misclassification, we note that the definition of non-patient facing MIPS eligible clinicians creates a minimum threshold for the quantity of patient-facing encounters that MIPS eligible clinicians or groups would need to furnish to be considered patient-facing, rather than classifying MIPS eligible clinicians as patient-facing based on a single patient-facing encounter. This approach allows for the definition of non-patient facing MIPS eligible clinicians to include both MIPS eligible clinicians who practice within specialties traditionally considered non-patient facing as well as MIPS eligible clinicians who provide occasional patient-facing services that do not represent the bulk of their practices. We believe our modified policy will allow us to more accurately identify MIPS eligible clinicians who are non-patient facing by applying a threshold in recognition of the fact that a MIPS eligible clinician who furnishes almost exclusively non-patient facing services should be treated as a non-patient facing MIPS eligible clinician despite furnishing a small number of patient-facing services.
However, as discussed above, we are finalizing a modification to our proposal to define a non-patient facing MIPS eligible clinician as an individual MIPS eligible clinician that bills 100 or fewer patient-facing encounters (including Medicare telehealth services defined in section 1834(m) of the Act) during the non-patient facing determination period, and a group provided that more than 75 percent of the NPIs billing under the group's TIN meet the definition of a non-patient facing individual MIPS eligible clinician during the non-patient facing determination period. When we applied our prior methodology to make determinations at the group level, the percentage of MIPS eligible clinicians classified as non-patient facing at the group level was higher because at the group level, MIPS eligible clinicians with less than 100 encounters who would otherwise be considered patient-facing (for example, pediatricians) are included in the group level calculation for the non-patient facing determination. Thus, there would be more specialists classified as non-patient facing when we make determinations at the group level, particularly when the percentage of specialists identified as non-patient facing at the group level is compared to the overall percentage of individual MIPS eligible clinicians. We note that the reason for the increase in the number of non-patient facing determinations is due to individual MIPS eligible clinicians in groups who have with less than 100 encounters would be classified as non-patient facing and would otherwise be considered patient-facing.
A few commenters indicated that when the proposed threshold is applied to groups without scaling the threshold by the number of clinicians in a group, a single individual clinician could push the entire group into the patient-facing category, even if the other individual clinicians in the group would, otherwise, be considered non-patient facing. One commenter indicated that the proposed definition of a non-patient facing MIPS eligible clinician would impact small and rural practices whose general radiologists perform more interventional procedures even though such patient-facing encounters represent only a very small fraction of the group's total Medicare services.
Several commenters provided alternative options for determining how the definition of non-patient facing MIPS eligible clinicians could be applied to groups. One commenter suggested scaling the patient-facing encounter threshold by the number of clinicians in a group practice while another commenter suggested doing so by patient-facing encounter codes. A few other commenters recommended one or more of the following alternatives: (1) Apply a patient-facing encounter threshold that is proportional to the group size, and, for non-patient facing MIPS eligible clinicians who meet the definition, identify such MIPS eligible clinicians at the beginning of the performance year; (2) classify groups based on whether the majority of individual MIPS eligible clinicians meet the threshold; (3) compare a group's average number of patient-facing encounters to the threshold, where a group's average would be defined by the total number of patient-facing encounters billed by the group divided by the number of MIPS eligible clinicians in the group and as a result, would not be skewed by a few MIPS eligible clinicians; or (4) redefine a non-patient facing MIPS eligible clinician by using the threshold of 50 or fewer patient-facing encounters per individual such that, if 51 percent or more members of the group individually fall below the threshold, then the entire group is considered non-patient facing.
Specifically, we are modifying our proposal to define a non-patient facing MIPS eligible clinician for MIPS as an individual MIPS eligible clinician that bills 100 or fewer patient-facing encounters (including Medicare telehealth services defined in section 1834(m) of the Act) during the non-patient facing determination period, and a group provided that more than 75 percent of the NPIs billing under the group's TIN meet the definition of a non-patient facing individual MIPS eligible clinician during the non-patient facing determination period.
In regard to the threshold applying at the group level, we recognize that groups vary in size and composition and thus, we believe that a percentage-based approach applies such a threshold equally across all types of groups. Also, we believe that a percentage-based threshold for groups is a more appropriate and accurate approach for distinguishing between groups composed of certain specialty or multi-specialty practices that should be considered non-patient facing. We are establishing a percentage-based threshold pertaining to groups above 75 percent in order to succinctly identify whether or not the majority of services furnished by groups are non-patient facing. We are specifying that more than 75 percent of the NPIs billing under the group's TIN would need to meet the
A few commenters discussed the definition of telehealth. One commenter recommended a revision to the current Medicare telehealth definition to reflect simple, plain language for MIPS
Also, a few commenters recommended that telehealth services should be restricted to true direct patient encounters (which would count toward a threshold of patient-facing encounters) and exclude the use of telehealth services by clinicians to consult with one another. One commenter disagreed with the eligibility criteria for telehealth services in contributing towards the scoring of the four performance categories and recommended that CMS treat telehealth services the same as all other in-person services for purposes of calculating MIPS program requirements.
For purposes of the 2019 MIPS payment adjustment, we will initially identify individual MIPS eligible clinicians and groups who are considered non-patient facing MIPS eligible clinicians based on 12 months of data starting from September 1, 2015 to August 31, 2016. In order to account for the identification of additional individual MIPS eligible clinicians and groups that may qualify as non-patient facing during the 2017 performance period, we will conduct another eligibility determination analysis based on 12 months of data starting from September 1, 2016 to August 31, 2017. In regard to the suggestion regarding the Quality Payment Program Service Center, we strive to ensure that any MIPS eligible clinician or group that will seeks assistance through the Quality Payment Program Service Center will be provided with adequate and consistent information pertaining to the various components of MIPS.
After consideration of the public comments we received, we are finalizing a modification to our proposal to define a non-patient facing MIPS eligible clinician for MIPS at § 414.1305 as an individual MIPS eligible clinician that bills 100 or fewer patient-facing encounters (including Medicare telehealth services defined in section 1834(m) of the Act) during the non-patient facing determination period, and a group provided that more than 75 percent of the NPIs billing under the group's TIN meet the definition of a non-patient facing individual MIPS eligible clinician during the non-patient facing determination period. As noted above, we believe that it would be beneficial for individual MIPS eligible clinicians and groups to know in advance of a performance period whether or not they qualify as a non-patient facing MIPS eligible clinician.
We establish the non-patient facing determination period for purposes of identifying non-patient facing MIPS eligible clinicians in advance of the performance period using historical claims data. This eligibility determination process will allow us to identify non-patient facing MIPS eligible clinicians prior to or shortly after the start of the performance period. In order to conduct an analysis of the data prior to the performance period, we are establishing an initial non-patient facing determination period consisting of 12 months. The initial 12-month segment of the non-patient facing determination period would span from the last 4 months of a calendar year 2 years prior to the performance period followed by the first 8 months of the next calendar year and include a 60-day claims run out, which will allow us to inform MIPS eligible clinicians and groups of their non-patient facing status during the month (December) prior to the start of the performance period. The second 12-month segment of the non-patient facing determination period would span from the last 4 months of a calendar year 1 year prior to the performance period followed by the first
Thus, for purposes of the 2019 MIPS payment adjustment, we will initially identify individual MIPS eligible clinicians and groups who are considered non-patient facing MIPS eligible clinicians based on 12 months of data starting from September 1, 2015 to August 31, 2016. In order to account for the identification of additional individual MIPS eligible clinicians and groups that may qualify as non-patient facing during the 2017 performance period, we will conduct another eligibility determination analysis based on 12 months of data starting from September 1, 2016 to August 31, 2017.
Similarly, for future years, we will conduct an initial eligibility determination analysis based on 12 months of data (consisting of the last 4 months of the calendar year 2 years prior to the performance period and the first 8 months of the calendar year prior to the performance period) to determine the non-patient facing status of individual MIPS eligible clinicians and groups, and conduct another eligibility determination analysis based on 12 months of data (consisting of the last 4 months of the calendar year prior to the performance period and the first 8 months of the performance period) to determine the non-patient facing status of additional individual MIPS eligible clinicians and groups. We will not change the non-patient facing status of any individual MIPS eligible clinician or group identified as non-patient facing during the first eligibility determination analysis based on the second eligibility determination analysis. Thus, an individual MIPS eligible clinician or group that is identified as non-patient facing during the first eligibility determination analysis will continue to be considered non-patient facing for the duration of the performance period regardless of the results of the second eligibility determination analysis. We will conduct the second eligibility determination analysis to account for the identification of additional, previously unidentified individual MIPS eligible clinicians and groups that are considered non-patient facing.
In addition, we consider a patient-facing encounter as the evaluation and management services (the denominators for the cross-cutting measures). Lastly, as noted above, we are finalizing our proposal to include Medicare telehealth services (as defined in section 1834(m) of the Act) in the definition of patient-facing encounters. We intend to publish a list of patient-facing encounters on the CMS Web site located at
Section 1848(q)(6)(E) of the Act provides that the MIPS payment adjustment is applied to the amount otherwise paid under Part B for the items and services furnished by a MIPS eligible clinician during a year (beginning with 2019). In the case of MIPS eligible clinicians who practice in CAHs that bill under Method I (“Method I CAHs”), the MIPS payment adjustment would apply to payments made for items and services billed by MIPS eligible clinicians under the PFS, but it would not apply to the facility payment to the CAH itself. In the case of MIPS eligible clinicians who practice in Method II CAHs and have not assigned their billing rights to the CAH, the MIPS payment adjustment would apply in the same manner as for MIPS eligible clinicians who bill for items and services in Method I CAHs.
Under section 1834(g)(2) of the Act, a Method II CAH bills and is paid for facility services at 101 percent of its reasonable costs and for professional services at 115 percent of such amounts as would otherwise be paid under Part B if such services were not included in outpatient CAH services. In the case of MIPS eligible clinicians who practice in Method II CAHs and have assigned their billing rights to the CAHs, those professional services would constitute “covered professional services” under section 1848(k)(3)(A) of the Act because they are furnished by an eligible clinician and payment is “based on” the PFS. Moreover, this is consistent with the precedent CMS has established by applying the PQRS and meaningful use payment adjustments to Method II CAH payments. Therefore, we proposed that the MIPS payment adjustment does apply to Method II CAH payments under section 1834(g)(2)(B) of the Act when MIPS eligible clinicians who practice in Method II CAHs have assigned their billing rights to the CAH. We requested comments on this proposal.
The following is a summary of the comments we received regarding our proposal that the MIPS payment adjustment does apply to Method II CAH payments under section 1834(g)(2)(B) of the Act when MIPS eligible clinicians who practice in Method II CAHs have assigned their billing rights to the CAH.
For Method II claims, this would involve scrubbing outpatient claims for services reported with professional revenue codes (96X, 97X and 98X) that are matched up with the applicable CPT codes. Commenters recommended an alternative, in which the Method II CAHs could be benchmarked only against themselves. Commenters indicated that the penalties would be relatively small, given that Method II CAHs bill primarily under Part A, but the publishing of these negative scores on Physician Compare will cause patients to seek care elsewhere, further destabilizing the rural delivery system.
In section II.E.5.g.(8)(a)(i) of this final rule with comment period, we noted that CAHs (and eligible hospitals) are subject to meaningful use requirements under sections 1886(b)(3)(B) and (n) and 1814(l) of the Act, respectively, which were not affected by the enactment of the MACRA. CAHs (and eligible hospitals) are required to report on objectives and measures of meaningful use under the EHR Incentive Program, as outlined in the 2015 EHR Incentive Programs final rule. The objectives and measures of the EHR Incentive Programs for CAHs (and eligible hospitals) are specific to these facilities, and are more applicable and better represent the EHR technology available in these settings. Section 1848(a)(7)(D) of the Act exempts hospital-based EPs from the application of the payment adjustment under the EHR Incentive Program and section 1848(a)(7)(B) of the Act provides the authority to exempt an EP who is not a meaningful EHR user from the application of the payment adjustment if it is determined that compliance with the meaningful EHR user requirements would result in a significant hardship, such as in the case of an EP who practices in a rural area without sufficient internet access. The MACRA did not maintain these statutory exceptions for the advancing care information performance category under MIPS. Thus, the exceptions under sections 1848(a)(7)(B) and (D) of the Act are limited to the meaningful use payment adjustment under section 1848(a)(7)(A) of the Act and do not apply in the context of the MIPS program.
Section 1848(q)(5)(F) of the Act provides the authority to assign different scoring weights (including a weight of zero) for each performance category if there are not sufficient measures and activities applicable and available to each type of MIPS eligible clinician, including hospital-based clinicians. Accordingly, as described in section II.E.5.g.(8)(a)(i) of this final rule with comment period, we may assign a weight of zero percentage for the advancing care information performance category for hospital-based MIPS eligible clinicians. Under MIPS, we define a hospital-based MIPS eligible clinician as a MIPS eligible clinician who furnishes 75 percent or more of his or her covered professional services in sites of service identified by the Place of Service (POS) codes 21, 22, and 23 used in the HIPAA standard transaction as an inpatient hospital, on campus outpatient hospital or emergency room setting in the year preceding the performance period. Consistent with the
After consideration of the public comments we received, we are finalizing our proposal that the MIPS payment adjustment will apply to Method II CAH payments under section 1834(g)(2)(B) of the Act when MIPS eligible clinicians who practice in Method II CAHs have assigned their billing rights to the CAH.
As noted in section II.E.1.d. of the proposed rule (81 FR 28176), section 1848(q)(6)(E) of the Act provides that the MIPS payment adjustment is applied to the amount otherwise paid under Part B with respect to the items and services furnished by a MIPS eligible clinician during a year. Some eligible clinicians may not receive MIPS payment adjustments due to their billing methodologies. If a MIPS eligible clinician furnishes items and services in an RHC and/or FQHC and the RHC and/or FQHC bills for those items and services under the RHC's or FQHC's all-inclusive payment methodology, the MIPS adjustment would not apply to the facility payment to the RHC or FQHC itself. However, if a MIPS eligible clinician furnishes other items and services in an RHC and/or FQHC and bills for those items and services under the PFS, the MIPS adjustment would apply to payments made for items and services. We note that eligible clinicians providing services for a RHC or FQHC as an employee or contractor is paid by the RHC or FQHC, not under the PFS. When a MIPS eligible clinician furnishes professional services in an RHC and/or FQHC, the RHC bills for those services under the RHC's all-inclusive rate methodology and the FQHC bills for those services under the FQHC prospective payment system methodology, in which the MIPS payment adjustment would not apply to the RHC or FQHC payment. Therefore, we proposed that services rendered by an eligible clinician that are payable under the RHC or FQHC methodology would not be subject to the MIPS payments adjustments. However, these eligible clinicians have the option to voluntarily report on applicable measures and activities for MIPS, in which the data received would not be used to assess their performance for the purpose of the MIPS payment adjustment. We requested comments on this proposal.
The following is a summary of the comments we received regarding our proposal that services rendered by an eligible clinician that are payable under the RHC or FQHC methodology would not be subject to the MIPS payments adjustments.
After consideration of the public comments we received, we are finalizing our proposal that services rendered by an eligible clinician under the RHC or FQHC methodology, will not be subject to the MIPS payments adjustments. However, these eligible clinicians have the option to voluntarily report on applicable measures and activities for MIPS, in which the data received will not be used to assess their performance for the purpose of the MIPS payment adjustment.
Section 1848(q)(1)(D) of the Act, requires the Secretary to establish and apply a process that includes features of the PQRS group practice reporting option (GPRO) established under section 1848(m)(3)(C) of the Act for MIPS eligible clinicians in a group for purposes of assessing performance in the quality performance category. In addition, it gives the Secretary the discretion to do so for the other three performance categories. Additionally, we will assess performance either for individual MIPS eligible clinicians or for groups. As discussed in section II.E.2.b. of the proposed rule (81 FR 28177), we proposed to define a group at § 414.1305 as a single Taxpayer Identification Number (TIN) with two or more MIPS eligible clinicians, as identified by their individual National Provider Identifier (NPI), who have reassigned their Medicare billing rights to the TIN. Also, as outlined in section II.E.2.c. of the proposed rule (81 FR 28177), we proposed to define an APM Entity group at § 414.1305 identified by a unique APM participant identifier. However, we are finalizing a modification to the definition of a group as described in section II.E.2.b. of this final rule with comment period and finalizing the definition of an APM Entity group as described in section II.E.2.c. of this final rule with comment period.
To support MIPS eligible clinicians reporting to a single comprehensive and cohesive MIPS program, we need to align the technical reporting requirements from PQRS, VM, and EHR-MU into one program. This requires an appropriate MIPS eligible clinician identifier. We currently use a variety of identifiers to assess an individual eligible clinician or group under different programs. For example, under the PQRS for individual reporting, CMS uses a combination of TIN and NPI to assess eligibility and
In the MIPS and APMs RFI (80 FR 63484), we sought comments on which specific identifier(s) should be used to identify a MIPS eligible clinician for purposes of determining eligibility, participation, and performance under the MIPS performance categories. In addition, we requested comments pertaining to what safeguards should be in place to ensure that MIPS eligible clinicians do not switch identifiers to avoid being considered “poor-performing” and comments on what safeguards should be in place to address any unintended consequences, if the MIPS eligible clinician identifier were a unique TIN/NPI combination, to ensure an appropriate assessment of the MIPS eligible clinician's performance. In the MIPS and APMs RFI (80 FR 63484), we sought comment on using a MIPS eligible clinician's TIN, NPI, or TIN/NPI combination as potential MIPS eligible clinician identifiers, or creating a unique MIPS eligible clinician identifier. The commenters did not demonstrate a consensus on a single best identifier.
Commenters favoring the use of the MIPS eligible clinician's TIN recommended that MIPS eligible clinicians should be associated with the TIN used for receiving payment from CMS claims. They further commented that this approach will deter MIPS eligible clinicians from “gaming” the system by switching to a higher performing group. Under this approach, commenters suggested that MIPS eligible clinicians who bill under more than one TIN can be assigned the performance and MIPS payment adjustment for the primary practice based upon majority of dollar amount of claims or encounters from the prior year.
Other commenters supported using unique TIN and NPI combinations to identify MIPS eligible clinicians. Commenters suggested many eligible clinicians are familiar with using TIN and NPI together from PQRS and other CMS programs. Commenters also noted this approach can calculate performance for multiple unique TIN/NPI combinations for those MIPS eligible clinicians who practice under more than one TIN. Commenters who supported the TIN/NPI also believed this approach enables greater accountability for individual MIPS eligible clinicians beyond what might be achieved when using TIN as an identifier and would provide a safeguard from MIPS eligible clinicians changing their identifier to avoid payment penalties.
Some commenters supported the use of only the NPI as the MIPS identifier. They believed this approach would best provide for individual accountability for quality in MIPS while minimizing potential confusion because providers do not generally change their NPI over time. Supporters of using the NPI only as the MIPS identifier also commented that this approach would be simplest for administrative purposes. These commenters also note the continuity inherent with the NPI would address the safeguard issue of providers attempting to change their identifier for MIPS performance purposes.
In the MIPS and APMs RFI (80 FR 63484), we also solicited feedback on the potential for creating a new MIPS identifier for the purposes of identifying MIPS eligible clinicians within the MIPS program. In response, many commenters indicated they would not support a new MIPS identifier. Commenters generally expressed concern that a new identifier for MIPS would only add to administrative burden, create confusion for MIPS eligible clinicians and increase reporting errors.
After reviewing the comments, we did not propose to create a new MIPS eligible clinician identifier. However, we appreciated the various ways a MIPS eligible clinician may engage with MIPS, either individually or through a group. Therefore, we proposed to use multiple identifiers that allow MIPS eligible clinicians to be measured as an individual or collectively through a group's performance. We also proposed that the same identifier be used for all four performance categories; for example, if a group is submitting information collectively, then it must be measured collectively for all four MIPS performance categories: Quality, cost, improvement activities, and advancing care information. As discussed in the final score methodology section II.E.6. of the proposed rule (81 FR 28247 through 28248), we proposed to use a single identifier, TIN/NPI, for applying the MIPS payment adjustment, regardless of how the MIPS eligible clinician is assessed. Specifically, if the MIPS eligible clinician is identified for performance only using the TIN, we proposed to use the TIN/NPI when applying the MIPS payment adjustment. We requested comments on these proposals.
The following is a summary of the comments we received regarding our proposals to use multiple identifiers that allow MIPS eligible clinicians to be measured as an individual or collectively through a group's performance and use a single identifier, TIN/NPI, for applying the MIPS payment adjustment.
In regard to how the definition of a group corresponds facility-based outpatient clinicians, we noted that the MIPS payment adjustment applies only to the amount otherwise paid under Part B with respect to items and services furnished by a MIPS eligible clinician during a year, in which we will apply the MIPS adjustment at the TIN/NPI level (see section II.E.7. of this final rule with comment period). For items and services furnished by such clinicians practicing in a facility that are billed by the facility, such items and services may be subject to MIPS adjustment based on the MIPS eligible clinician's performance during the applicable performance period. For those billed Medicare Part B allowed charges we are
We do not believe that the definition of a group would create complications for eligible clinicians associated with multiple TINs. We note that individual eligible clinicians would be required to meet the MIPS requirements for each TIN/NPI association unless they are excluded from MIPS based on an exclusion established in section II.E.3. of this final rule with comment period.
After consideration of the public comments we received, we are finalizing the use of multiple identifiers that allow MIPS eligible clinicians to be measured as an individual or collectively through a group's performance. Additionally, we are finalizing our proposal that the same identifier be used for all four performance categories. For example, if a group is submitting information collectively, then it must be measured collectively for all four MIPS performance categories: Quality, cost, improvement activities, and advancing care information. While we have multiple identifiers for participation and performance, we are finalizing the use of a single identifier, TIN/NPI, for applying the MIPS payment adjustment, regardless of how the MIPS eligible clinician is assessed (see final score methodology outlined in section II.E.6. of this final rule with comment period). Specifically, if the MIPS eligible clinician is identified for performance only using the TIN, we will use the TIN/NPI when applying the MIPS payment adjustment.
We proposed to use a combination of billing TIN/NPI as the identifier to assess performance of an individual MIPS eligible clinician. Similar to PQRS, each unique TIN/NPI combination would be considered a different MIPS eligible clinician, and MIPS performance would be assessed separately for each TIN under which an individual bills. While we considered using the NPI only, we believe TIN/NPI is a better approach for MIPS. Both TIN and NPI are needed for payment purposes and using a combination of billing TIN/NPI as the MIPS eligible clinician identifier allows us to match MIPS performance and MIPS payment adjustments with the appropriate practice, particularly for MIPS eligible clinicians that bill under more than one TIN. In addition, using TIN/NPI also provides the flexibility to allow individual MIPS eligible clinician and group reporting, as the proposed group identifiers also include TIN as part of the identifier. We recognize that TIN/NPI is not a static identifier and can change if an individual MIPS eligible clinician changes practices and/or if a group merges with another between the performance period and payment adjustment period. Section II.E.7.a. of the proposed rule describes in more detail how we proposed to match performance in cases where the TIN/NPI changes. We requested comments on this proposal.
The following is a summary of the comments we received regarding our proposal to use a combination of billing TIN/NPI as the identifier to assess performance of an individual MIPS eligible clinician.
After consideration of the public comments we received, we are finalizing our proposed definition of a MIPS eligible clinician at § 414.1305 to use a combination of unique billing TIN and NPI combination as the identifier to assess performance of an individual MIPS eligible clinician. Each unique TIN/NPI combination will be considered a different MIPS eligible clinician, and MIPS performance will be assessed separately for each TIN under which an individual bills. We recognize that TIN/NPI is not a static identifier and can change if an individual MIPS eligible clinician changes practices and/or if a group merges with another between the performance period and payment adjustment period. We refer readers to section II.E.7.a. of this final rule with comment period, which describes our final policy for matching performance in cases where the TIN/NPI changes.
We proposed the following way a MIPS eligible clinician may have their performance assessed as part of a group under MIPS. We proposed to use a group's billing TIN to identify a group. This approach has been used as a group identifier for both PQRS and VM. The use of the TIN would significantly reduce the participation burden that could be experienced by large groups. Additionally, the utilization of the TIN benefits large and small practices by allowing such entities to submit performance data one time for their group and develop systems to improve performance. Groups that report on quality performance measures through certain data submission methods must register to participate in MIPS as described in section II.E.5.b. of the proposed rule.
We proposed to codify the definition of a group at § 414.1305 as a group that would consist of a single TIN with two or more MIPS eligible clinicians (as identified by their individual NPI) who have reassigned their billing rights to the TIN. We requested comments on this proposal.
The following is a summary of the comments we received regarding our proposal establishing the way a MIPS eligible clinician may have their performance assessed as part of a group under MIPS.
After consideration of the public comments we received, we are finalizing a modification to our proposal regarding the use of a group's billing TIN to identify a group. Thus, we are codifying the definition of a group at § 414.1305 to mean a group that consists of a single TIN with two or more eligible clinicians (including at least one MIPS eligible clinician), as identified by their individual NPI, who have reassigned their billing rights to the TIN.
We proposed the following way to identify a group to support APMs (see section II.F.5.b. of this rule). To ensure we have accurately captured all of the eligible clinicians identified as participants that are participating in the APM Entity, we proposed that each eligible clinician who is a participant of an APM Entity would be identified by a unique APM participant identifier. The unique APM participant identifier would be a combination of four identifiers: (1) APM Identifier (established by CMS; for example, XXXXXX); (2) APM Entity identifier (established under the APM by CMS; for example, AA00001111); (3) TIN(s) (9 numeric characters; for example, XXXXXXXXX); (4) EP NPI (10 numeric characters; for example, 1111111111). For example, an APM participant identifier could be APM XXXXXX, APM Entity AA00001111, TIN-XXXXXXXXX, NPI-11111111111.
We proposed to codify the definition of an APM Entity group at § 414.1305 as an APM Entity identified by a unique APM participant identifier. We requested comments on these proposals. See section II.E.5.h. of the proposed rule for proposed policies regarding requirements for APM Entity groups under MIPS.
The following is a summary of the comments we received regarding our proposal establishing the way each eligible clinician who is a participant of an APM Entity would be identified by a unique APM participant identifier.
After consideration of the public comments we received, we are finalizing our proposal that each eligible clinician who is a participant of an APM Entity will be identified by a unique APM participant identifier. The unique APM participant identifier will be a combination of four identifiers: (1) APM Identifier (established by CMS; for example, XXXXXX); (2) APM Entity identifier (established under the APM by CMS; for example, AA00001111); (3) TIN(s) (9 numeric characters; for example, XXXXXXXXX); (4) EP NPI (10 numeric characters; for example, 1111111111). For example, an APM participant identifier could be APM XXXXXX, APM Entity AA00001111, TIN-XXXXXXXXX, NPI-11111111111. Thus, we are codifying the definition of an APM Entity group at § 414.1305 to mean a group of eligible clinicians participating in an APM Entity, as identified by a combination of the APM identifier, APM Entity identifier, Taxpayer Identification Number (TIN), and National Provider Identifier (NPI) for each participating eligible clinician.
Section 1848(q)(1)(C)(v) of the Act provides that in the case of a professional who first becomes a Medicare-enrolled eligible clinician during the performance period for a year (and had not previously submitted claims under Medicare either as an individual, an entity, or a part of a physician group or under a different billing number or tax identifier), that the eligible clinician will not be treated as a MIPS eligible clinician until the subsequent year and performance period for that year. In addition, section 1848(q)(1)(C)(vi) of the Act clarifies that individuals who are not deemed MIPS eligible clinicians for a year will not receive a MIPS payment adjustment. Accordingly, we proposed at § 414.1305 that a new Medicare-enrolled eligible clinician be defined as a professional who first becomes a Medicare-enrolled eligible clinician within the PECOS during the performance period for a year and who has not previously submitted claims as a Medicare-enrolled eligible clinician either as an individual, an entity, or a part of a physician group or under a different billing number or tax identifier. These eligible clinicians will not be treated as a MIPS eligible clinician until the subsequent year and the performance period for such subsequent year. As discussed in section II.E.4. of the proposed rule (81 FR 28179 through 28181), we proposed that the MIPS performance period would be the calendar year (January 1 through December 31) 2 years prior to the year in which the MIPS payment adjustment is applied. For example, an eligible clinician who newly enrolls in Medicare within PECOS in 2017 would not be required to participate in MIPS in 2017, and he or she would not receive a MIPS payment adjustment in 2019. The same eligible clinician would be required to participate in MIPS in 2018 and would receive a MIPS payment adjustment in 2020, and so forth. In addition, in the case of items and services furnished during a year by an individual who is not an MIPS eligible clinician, there will not be a MIPS payment adjustment applied for that year. We also proposed at § 414.1310(d) that in no case would a MIPS payment adjustment apply to the items and services furnished by new Medicare-enrolled eligible clinicians. We requested comments on these proposals.
The following is a summary of the comments we received regarding our proposals to define a new Medicare-enrolled eligible clinician as a professional who first becomes a Medicare-enrolled eligible clinician within the PECOS during the performance period for a year and who has not previously submitted claims under Medicare either as an individual, an entity, or a part of a physician group or under a different billing number or tax identifier, that the eligible clinician would not be treated as a MIPS eligible clinician until the subsequent year and performance period for such subsequent year, that a MIPS payment adjustment would not be applied in the case of items and services furnished during a year by an individual who is not an MIPS eligible clinician, and that in no case would a MIPS payment adjustment apply to the items and services furnished by new Medicare-enrolled eligible clinicians.
Moreover, section 1848(q)(1)(C)(vi) of the Act clarifies that individuals who are not deemed MIPS eligible clinicians for a year will not receive a MIPS payment adjustment. Accordingly, we define a new Medicare-enrolled eligible clinician as a professional who first becomes a Medicare-enrolled eligible clinician within the PECOS during the performance period for a year and who has not previously submitted claims as a Medicare-enrolled eligible clinician either as an individual, an entity, or a part of a physician group or under a different billing number or tax identifier. These eligible clinicians will not be treated as a MIPS eligible clinician until the subsequent year and the performance period for such subsequent year. Thus, such eligible clinicians would be treated as a MIPS eligible clinician in their subsequent year of being a Medicare-enrolled eligible clinician, required to participate in MPS, and subject to the MIPS payment adjustment for the performance period of that subsequent year.
After consideration of the public comments we received, we are finalizing the definition of a new Medicare-enrolled eligible clinician at § 414.1305 as a professional who first becomes a Medicare-enrolled eligible clinician within the PECOS during the performance period for a year and had not previously submitted claims under Medicare such as an individual, an entity, or a part of a physician group or under a different billing number or tax identifier. We are finalizing our proposal at § 414.1310(c) that these eligible clinicians will not be treated as a MIPS eligible clinician until the subsequent year and the performance period for such subsequent year. As outlined in section II.E.4. of this final rule with comment period, we are finalizing a modification to the MIPS performance period to be a minimum of one continuous 90-day period within CY 2017. In the case of items and services furnished during a year by an individual who is not a MIPS eligible clinician during the performance period, there will not be a MIPS payment adjustment applied for that payment adjustment year. Additionally, we are finalizing our proposal at § 414.1310(d) that in no case would a MIPS payment adjustment apply to the items and services furnished during a year by new Medicare-enrolled eligible clinicians for the applicable performance period.
We believe that it would be beneficial for eligible clinicians to know during the performance period of a calendar year whether or not they are identified as a new Medicare-enrolled eligible clinician. For purposes of this section,
Sections 1848(q)(1)(C)(ii)(I) and (II) of the Act provide that the definition of a MIPS eligible clinician does not include, for a year, an eligible clinician who is a Qualifying APM Participant (QP) (as defined in section 1833(z)(2) of the Act) or a Partial Qualifying APM Participant (Partial QP) (as defined in section 1848(q)(1)(C)(iii) of the Act) who does not report on the applicable measures and activities that are required under MIPS. Section II.F.5. of the proposed rule provides detailed information on the determination of QPs and Partial QPs.
We proposed that the definition of a MIPS eligible clinician at § 414.1310 does not include QPs (defined at § 414.1305) and Partial QPs (defined at § 414.1305) who do not report on applicable measures and activities that are required to be reported under MIPS for any given performance period. Partial QPs will have the option to elect whether or not to report under MIPS, which determines whether or not they will be subject to MIPS payment adjustments. Please refer to the section II.F.5.c. of the proposed rule where this election is discussed in greater detail. We requested comments on this proposal.
The following is a summary of the comments we received regarding our proposal that the definition of a MIPS eligible clinician does not include QPs (defined at § 414.1305) and Partial QPs (defined at § 414.1305) who do not report on applicable measures and activities that are required to be reported under MIPS for any given performance period, in which Partial QPs will have the option to elect whether or not to report under MIPS.
After consideration of the public comments we received, we are finalizing our proposal at § 414.1305 that the definition of a MIPS eligible clinician does not include QPs (defined at § 414.1305) and Partial QPs (defined at § 414.1305) who do not report on applicable measures and activities that are required to be reported under MIPS for any given performance period in a year. Also, we are finalizing our proposed policy at § 414.1310(b) that for a year, QPs (defined at § 414.1305) and Partial QPs (defined at § 414.1305) who do not report on applicable measures and activities that are required to be reported under MIPS for any given performance period in a year are excluded from MIPS. Partial QPs will have the option to elect whether or not to report under MIPS, which determines whether or not they will be subject to MIPS payment adjustments.
Section 1848(q)(1)(C)(ii)(III) of the Act provides that the definition of a MIPS eligible clinician does not include MIPS eligible clinicians who are below the low-volume threshold selected by the Secretary under section 1848(q)(1)(C)(iv) of the Act for a given year. Section 1848(q)(1)(C)(iv) of the Act requires the Secretary to select a low-volume threshold to apply for the purposes of this exclusion which may include one or more of the following: (1) T he minimum number, as determined by the Secretary, of Part B-enrolled individuals who are treated by the MIPS eligible clinician for a particular performance period; (2) the minimum number, as determined by the Secretary, of items and services furnish to Part B-enrolled individuals by the MIPS eligible clinician for a particular performance period; and (3) the minimum amount, as determined by the Secretary, of allowed charges billed by the MIPS eligible clinician for a particular performance period.
We proposed at § 414.1305 to define MIPS eligible clinicians or groups who do not exceed the low-volume threshold as an individual MIPS eligible clinician or group who, during the performance period, have Medicare billing charges less than or equal to $10,000 and provides care for 100 or fewer Part B-enrolled Medicare beneficiaries. We believed this strategy holds more merit as it retains as MIPS eligible clinicians those MIPS eligible clinicians who are treating relatively few beneficiaries, but engage in resource intensive specialties, or those treating many beneficiaries with relatively low-priced services. By requiring both criteria to be met, we can meaningfully measure the performance and drive quality improvement across the broadest range of MIPS eligible clinician types and specialties. Conversely, it excludes MIPS eligible clinicians who do not have a substantial quantity of interactions with Medicare beneficiaries or furnish high cost services.
In developing this proposal, we considered using items and services furnished to Part B-enrolled individuals by the MIPS eligible clinician for a particular performance period rather than patients, but a review of the data reflected there were nominal differences between the two methods. We plan to monitor the proposed requirement and anticipate that the specific thresholds will evolve over time. We requested comments on this proposal including alternative patient threshold, case thresholds, and dollar values.
The following is a summary of the comments we received regarding our proposal to define MIPS eligible clinicians or groups who do not exceed the low-volume threshold as an individual MIPS eligible clinician or group who, during the performance period, have Medicare billing charges less than or equal to $10,000 and provides care for 100 or fewer Part B-enrolled Medicare beneficiaries.
A few commenters indicated that an increase in the low-volume threshold would mitigate an undue burden on small practices. One commenter stated that RHCs and such clinicians will have fewer than $10,000 in Medicare billing charges, but many of them will have more than 100 Part B beneficiaries under their care. The commenter expressed concern that RHCs may be burdened with MIPS requirements for a low level of Part B claims and thus, may either face penalties or the cost of implementing the MIPS requirements. A few commenters indicated that the low-volume threshold should be high enough to exempt physicians who have no possibility of a positive return on their investment in the cost of reporting.
Other recommendations from commenters included the following: align the patient cap with the CPC+ patient panel requirements, which would increase the number of Medicare Part B beneficiaries cared for to 150 (and would prevent clinicians from having two different low-volume thresholds within the same program); exclude groups from participation in MIPS based on an aggregated threshold for the group with the rate of $30,000 and 100 patients per clinician, in which a group of two eligible clinicians would be excluded if charging under $60,000 and caring for under 200 Medicare Part B-enrolled Medicare beneficiaries; exempt MIPS eligible clinicians for the transition year of MIPS who bill under Place of Service 20, which is the designation for a place with the purpose of diagnosing and treating illness or injury for unscheduled, ambulatory patients seeking immediate medical attention; and exempt facilities operating in Frontier areas from MIPS participation, at least until 2019 when the list of MIPS eligible clinicians expands and additional MIPS eligible clinicians are able to participate in MIPS.
There were other commenters who requested that the threshold criteria regarding the dollar value of Medicare billed charges and the number of Medicare Part B beneficiaries cared for be increased to the following: $25,000 Medicare billed charges or 50 or 100 Part B beneficiaries; $50,000 Medicare billed charges or 100 or 150 Part B beneficiaries; $75,000 Medicare billed charges or 100 or 750 Part B beneficiaries; $100,000 Medicare billed charges or 1000 Part B beneficiaries; $250,000 Medicare billed charges or 150 Part B beneficiaries; and $500,000 Medicare billed charges or 400 or 500 Part B beneficiaries.
Several commenters requested that CMS temporarily increase the low-volume threshold in order for small practices to not be immediately impacted by the implementation of MIPS. One commenter suggested that the threshold be increased to 250 unique Medicare patients and a total Medicare billing not to exceed $200,000 for 5 years. Another commenter recommended that CMS set the low-volume threshold in 2019 at $250,000 of
In regard to the comment pertaining to the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA), we note that the MHPAEA generally prevents group health plans and health insurance issuers that provide mental health or substance use disorder benefits from imposing less favorable benefit limitations on those benefits than on medical/surgical benefits. The mental health parity requirements of MHPAEA do not apply to Medicare.
Thus, for purposes of the 2019 MIPS payment adjustment, we will initially identify the low-volume status of individual eligible clinicians and groups based on 12 months of data starting from September 1, 2015 to August 31, 2016, with a 60 day claims run out. To account for the identification of additional individual eligible clinicians and groups who do not exceed the low-volume threshold during the 2017 performance period, we will conduct another eligibility determination analysis based on 12 months of data starting from September 1, 2016 to August 31, 2017, with a 60 day claims run out. For example, MIPS eligible clinicians who may have exceeded the low-volume threshold during the first determination assessment, but fall below the threshold during the performance period because their practice changed significantly, they changed practices from a prior year, etc.
In addition, we note that the low-volume threshold exclusion is determined at the individual (TIN/NPI) level for individual reporting and at the group (TIN) level for group reporting. An eligible clinician may be identified as having a status that does not exceed the low-volume threshold at the individual (TIN/NPI) level, but if such eligible clinician is part of a group that is identified as having a status exceeding the low-volume threshold, such eligible clinician would be required to participate in MIPS as part of the group because the low-volume threshold is determined at the group (TIN) level for groups. For eligibility determinations pertaining to the low-volume threshold exclusion, we will be conducting our analysis for each TIN/NPI and TIN identified in the claims data and make a determination based on the Medicare Part B allowed charges billed. Since we are making eligibility determinations for each TIN/NPI and TIN identified in the claims data, we do not need to know whether or not a group is reporting at the individual or group level prior to our analyses. Thus, groups can use the eligibility determinations we make for each TIN/NPI and TIN to determine whether or not their group would be reporting at the individual or group level. Subsequently, groups reporting at the group level would need to meet the group requirements as discussed in section II.E.3.d. of this final rule with comment period.
One commenter requested that CMS issue a clarification stating that when clinicians choose to have their performance assessed at the group level, the low-volume threshold would also be assessed at the group level. This would ensure consistent treatment. Another commenter requested clarity regarding the low-volume threshold exclusion definition for groups, and recommended that CMS apply a multiplying factor for each enrolled Medicare clinician in the group definition. One commenter recommended that CMS scale the minimum number of Part B-enrolled Medicare beneficiaries and Medicare billed charges to the number of physician group members while another commenter requested that if a practice reports as a group, the low-volume threshold should be multiplied by the number of clinicians in the group. Commenters recommended a higher threshold for groups.
A few commenters indicated that the current proposal does not provide a meaningful exclusion for small and rural practices that cannot afford the upfront investments (including investments in EHR systems) and as a result of the high costs to report for small practices, the threat of negative MIPS payment adjustments or low positive MIPS payment adjustments that do not cover the costs to report would deter small practices from participating in MIPS.
In addition, we believe that the modified proposal reduces the risk of clinicians withdrawing as Medicare suppliers and minimizing the number of Medicare beneficiaries that they treat in a year. We will monitor any effect on Medicare participation in CY 2017 and future calendar years.
After consideration of the public comments we received, we are finalizing a modification to our proposal to define MIPS eligible clinicians or groups who do not exceed the low-volume threshold. At § 414.1305, we are defining MIPS eligible clinicians or groups who do not exceed the low-volume threshold as an individual MIPS eligible clinician or group who, during the low-volume threshold determination period, has Medicare Part B billing charges less than or equal to $30,000 or provides care for 100 or fewer Part B-enrolled Medicare beneficiaries. We are finalizing our proposed policy at § 414.1310(b) that for a year, MIPS eligible clinicians who do not exceed the low-volume threshold (as defined at § 414.1305) are excluded from MIPS for the performance period with respect to a year. The low-volume threshold also applies to MIPS eligible clinicians who practice in APMs under the APM scoring standard at the APM Entity level, in which APM Entities that do not exceed the low-volume threshold would be excluded from the MIPS requirements and not subject to a MIPS payment adjustment. Such an exclusion will not affect an APM Entity's QP determination if the APM Entity is an Advanced APM. Additionally, because we agree that it would be beneficial for individual eligible clinicians and groups to know whether they are excluded under the low-volume threshold prior to the start of the performance period, we are finalizing a modification to our proposal to allow us to make eligibility determinations regarding low-volume status using historical data. This modification will allow us to inform individual MIPS eligible clinicians and groups of their low-volume status prior to the performance period. We establish the low-volume threshold determination period to refer to the timeframe used to assess claims data for making eligibility determinations for the low-volume threshold exclusion. We define the low-volume threshold determination period to mean a 24-month assessment period, which includes a two-segment analysis of claims data during an initial 12-month period prior to the performance period followed by another 12-month period during the performance period. In order to conduct an analysis of the data prior to the performance period, we are establishing an initial low-volume threshold determination period consisting of 12 months. The initial 12-month segment of the low-volume threshold determination period would span from the last 4 months of a calendar year 2 years prior to the performance period followed by the first 8 months of the next calendar year and include a 60-day claims run out, which will allow us to inform eligible clinicians and groups of their low-volume status during the month (December) prior to the start of the performance period. The second 12-month segment of the low-volume threshold determination period would span from the last 4 months of a calendar year 1 year prior to the performance period followed by the first 8 months of the performance period in the next calendar year and include a 60-day claims run out, which will allow us to inform additional eligible clinicians and groups of their low-volume status during the performance period.
Thus, for purposes of the 2019 MIPS payment adjustment, we will initially identify the low-volume status of individual eligible clinicians and groups based on 12 months of data starting from September 1, 2015 to August 31, 2016. In order to account for the identification of additional individual eligible clinicians and groups that do not exceed the low-volume threshold during the 2017 performance period, we will conduct another eligibility determination analysis based on 12 months of data starting from September 1, 2016 to August 31, 2017. For example, eligible clinicians who may have exceeded the low-volume threshold during the first determination assessment, but fall below the threshold during the performance period because their practice changed significantly, they changed practices from a prior year, etc. Similarly, for future years, we will conduct an initial eligibility determination analysis based on 12 months of data (consisting of the last 4 months of the calendar year 2 years prior to the performance period and the first 8 months of the calendar year prior to the performance period) to determine the low-volume status of individual eligible clinicians and groups, and conduct another eligibility determination analysis based on 12 months of data (consisting of the last 4 months of the calendar year prior to the performance period and the first 8 months of the performance period) to determine the low-volume status of additional individual MIPS eligible clinicians and groups. We will not change the low-volume status of any individual eligible clinician or group identified as not exceeding the low-volume threshold during the first eligibility determination analysis based on the second eligibility determination analysis. Thus, an individual eligible clinician or group that is identified as not exceeding the low-volume threshold during the first eligibility determination analysis will continue to be excluded from MIPS for the duration of the performance period regardless of the results of the second eligibility determination analysis. We will conduct the second eligibility determination analysis to account for the identification of additional, previously unidentified individual eligible clinicians and groups who do not exceed the low-volume threshold.
We recognize that the low-volume threshold determination period effectively combines two 12-month segments from 2 consecutive calendar years, in which the two 12-month periods of data that would be used for our analysis will not align with the calendar years. Also, we note that the low-volume threshold determination period may impact new Medicare-enrolled eligible clinicians who are excluded from MIPS participation for the performance period in which they are identified as new Medicare-enrolled eligible clinicians. Such clinicians would ordinarily begin participating in MIPS in the subsequent year, but under our modified low-volume threshold, are more likely to be excluded for a second year. The low-volume threshold exclusion may apply if, for example, such eligible clinician became a new Medicare-enrolled eligible clinician during the last 4 months of the calendar year and did not exceed the low-volume threshold of billed Medicare Part B allowed charges. Since the initial eligibility determination period consists of the last 4 months of the calendar year 2 years prior to the performance period
As noted in section II.E.1.e. of the proposed rule (81 FR 28176), section 1848(q)(1)(D) of the Act, requires the Secretary to establish and apply a process that includes features of the PQRS group practice reporting option (GPRO) established under section 1848(m)(3)(C) of the Act for MIPS eligible clinicians in a group for the purpose of assessing performance in the quality category and gives the Secretary the discretion to do so for the other performance categories. The process established for purposes of MIPS must, to the extent practicable, reflect the range of items and services furnished by the MIPS eligible clinicians in the group. We believe this means that the process established for purposes of MIPS should, to the extent practicable, encompass elements that enable MIPS eligible clinicians in a group to meet reporting requirements that reflect the range of items and services furnished by the MIPS eligible clinicians in the group. At § 414.1310(e), we proposed requirements for groups. For purposes of section 1848(q)(1)(D) of the Act, at § 414.1310(e)(1) we proposed the following way for individual MIPS eligible clinicians to have their performance assessed as a group: As part of a single TIN associated with two or more MIPS eligible clinicians, as identified by a NPI, that have their Medicare billing rights reassigned to the TIN (as discussed further in section II.E.2.b. of the proposed rule).
To have its performance assessed as a group, at § 414.1310(e)(2), we proposed a group must meet the proposed definition of a group at all times during the performance period for the MIPS payment year. Additionally, at § 414.1310(e)(3) we proposed in order to have their performance assessed as a group, individual MIPS eligible clinicians within a group must aggregate their performance data across the TIN. At § 414.1310(e)(3), we proposed that a group electing to have its performance assessed as a group would be assessed as a group across all four MIPS performance categories. For example, if a group submits data for the quality performance category as a group, CMS would assess them as a group for the remaining three performance categories. We solicited public comments on the proposal regarding how groups will be assessed under MIPS.
The following is a summary of the comments we received regarding our proposed requirements for groups, including: Individual MIPS eligible clinicians would have their performance assessed as a group as part of a single TIN associated with two or more MIPS eligible clinicians, as identified by a NPI, that have their Medicare billing rights reassigned to the TIN; a group must meet the definition of a group at all times during the performance period for the MIPS payment year; individual MIPS eligible clinicians within a group must aggregate their performance data across the TIN in order for their performance to be assessed as a group; and a group that elects to have its performance assessed as a group would be assessed as a group across all four MIPS performance categories.
A group electing to submit data at the group level would have its performance assessed and scored across the TIN, which could include items and services furnished by individual NPIs within the TIN who are not required to participate in MIPS. For example, excluded eligible clinicians (new Medicare-enrolled, QPs, or Partial QPs who do not report on applicable MIPS measures and activities, and do not exceed the low-volume threshold) are part of the group, and therefore, would be considered in the group's score. However, the MIPS payment adjustment would apply differently at the group level in relation to each exclusion circumstance. For example, groups reporting at the group level that include new Medicare-enrolled eligible clinicians, or QPs or Partial QPs would have the MIPS payment adjustment only apply to the Medicare Part B allowed charges pertaining to the group's MIPS eligible clinicians and the MIPS payment adjustment would not apply to such clinicians excluded from MIPS based on these two types of exclusions. We reiterate that any individual (NPI) excluded from MIPS because they are identified as new Medicare-enrolled, QP, or Partial QP would not receive a MIPS payment adjustment, regardless of their MIPS participation.
We note that the low-volume threshold is different from the other two exclusions in that it is not determined solely based on the individual NPI status, it is based on both the TIN/NPI (to determine an exclusion at the individual level) and TIN (to determine an exclusion at the group level) status. In regard to group-level reporting, the group, as a whole, is assessed to determine if the group (TIN) exceeds the low-volume threshold. Thus, eligible clinicians (TIN/NPI) who do not exceed the low-volume threshold at the individual reporting level and would otherwise be excluded from MIPS participation at the individual level, would be required to participate in MIPS at the group level if such eligible clinicians are part of a group reporting at the group level that exceeds the low-volume threshold.
We considered aligning how the MIPS exclusions would be applied at the group level for each of the three exclusion circumstances. We recognize that alignment would provide a uniform application across the three exclusions and offer simplicity, but we also believe it is critical to ensure that there are opportunities encouraging coordination, teamwork, and shared responsibility within groups. In order to encourage coordination, teamwork, and shared responsibility at the group level, we will assess the low-volume threshold so that all clinicians within the group have the same status: All clinicians collectively exceed the low-volume threshold or they do not exceed the low-volume threshold.
In addition, we recognize that individual clinicians who do not meet the definition of a MIPS eligible clinician during the first 2 years of MIPS such as physical and occupational therapists, clinical social workers, and others are not MIPS eligible. Thus, such clinicians are not required to participate in MIPS, but may voluntarily report measures and activities for MIPS. For those clinicians not MIPS eligible who voluntarily report for MIPS, they would not receive a MIPS payment adjustment. Accordingly, groups reporting at the group level may voluntarily include such eligible clinicians in its aggregated data that would be reported for measure and activities under MIPS. For groups reporting at the group level that voluntarily include eligible clinicians who do not meet the definition of a MIPS eligible clinician, they would have their performance assessed and scored across the TIN, but those clinicians would not receive a MIPS payment adjustment, regardless of their MIPS voluntary participation. We further note that these clinicians who are not eligible for MIPS, but volunteer to report, would not receive a MIPS payment adjustment.
We are finalizing our proposals regarding group requirements; however, we welcome additional comment on: How we are applying the application of group-related policies pertaining to group-level performance assessment and scoring and the MIPS payment adjustment to groups with eligible clinicians excluded from MIPS based on the three exclusions or not MIPS eligible for the first 2 years of MIPS; the advantages and disadvantages of how we are applying the application of group-related policies when groups include eligible clinicians excluded from the requirement to participate in MIPS at the individual level; and alternative approaches that could be considered.
After consideration of the public comments we received, we are finalizing a modification to the following proposed policy:
• Individual MIPS eligible clinicians who choose to report as a group will have their performance assessed as part of a single TIN associated with two or more eligible clinicians (including at least one MIPS eligible clinician), as identified by a NPI, that have their Medicare billing rights reassigned to the TIN (§ 414.1310(e)(1)).
In addition, we are finalizing the following policies:
• A group must meet the definition of a group at all times during the performance period for the MIPS payment year in order to have its performance to be assessed as a group (§ 414.1310(e)(2)).
• Eligible clinicians and MIPS eligible clinicians within a group must aggregate their performance data across the TIN in order for their performance to be assessed as a group (§ 414.1310(e)(3)).
• A group that elects to have its performance assessed as a group will be assessed as a group across all four MIPS performance categories (§ 414.1310(e)(4)).
Under the PQRS, groups are required to complete a registration process to participate in PQRS as a group. During the implementation and administration of PQRS, we received feedback from stakeholders regarding the registration process for the various methods available for data submission. Stakeholders indicated that the registration process was burdensome and confusing. Additionally, we discovered that during the registration process when groups are required to select their group submission mechanism, groups sometimes selected the option not applicable to their group, which has created issues surrounding the mismatch of data. Unreconciled data mismatching can impact the quality of data. To address this issue, we proposed to eliminate a registration process for groups submitting data using third party entities. When groups submit data utilizing third party entities, such as a qualified registry, QCDR, or EHR, we are able to obtain group information from the third party entity and discern whether the data submitted represents group submission or individual submission once the data are submitted.
At § 414.1310(e)(5), we proposed that a group must adhere to an election process established and required by CMS, as described in this section. We did not propose to require groups to register to have their performance assessed as a group except for groups submitting data on performance measures via participation in the CMS Web Interface or groups electing to report the Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS survey for the quality performance category as described further in section II.E.5.b. of the proposed rule. For all other data submission mechanisms, groups must work with appropriate third party entities to ensure the data submitted clearly indicates that the data represent a group submission rather than an individual submission. In order for groups to elect participation via the CMS Web Interface or administration of the CAHPS for MIPS survey, we proposed that such groups must register by June 30 of the applicable 12-month performance period (that is, June 30, 2017, for performance periods occurring in 2017). For the criteria regarding group reporting applicable to the four MIPS performance categories, see section II.E.5.a. of the proposed rule.
The following is a summary of the comments we received regarding our proposal that requires a group participating via the CMS Web Interface or electing to administer the CAHPS for MIPS survey to adhere to an election process established and required by CMS.
We encourage groups to review the measure specifications for each data submission mechanism and select the data submission mechanism that applies best to the group prior to registering to participate via the CMS Web Interface. We want to note that groups can determine if they would have Medicare beneficiaries to report data on behalf of for the CMS Web Interface measures. Groups that register to use the CMS Web Interface prior to the registration deadline (June 30) can cancel their registration or change their selection to report at an individual or group level only during the timeframe before the close of registration.
After consideration of the public comments we received, we are finalizing the following policy:
• A group must adhere to an election process established and required by CMS (§ 414.1310(e)(5)), which includes:
++ Groups will not be required to register to have their performance assessed as a group except for groups submitting data on performance measures via participation in the CMS Web Interface or groups electing to report the CAHPS for MIPS survey for the quality performance category. For all other data submission methods, groups must work with appropriate third party entities as necessary to ensure the data submitted clearly indicates that the data represent a group submission rather than an individual submission.
++ In order for groups to elect participation via the CMS Web Interface or administration of the CAHPS for MIPS survey, such groups must register by June 30 of the applicable performance period (that is, June 30, 2017, for performance periods occurring in 2017).
Additionally, for operational purposes, we are considering the establishment of a voluntary registration process, if technically feasible, for groups that intend to submit data on performance measures via a qualified registry, QCDR, or EHR, which will enable such groups to specify whether or not they intend to participate as a group and which submission
With the optional participation in a voluntary registration process, the assessment of a group's performance would not be impacted by whether or not a group elects to participate in voluntary registration. We note that if a group voluntarily registers, information provided by the group would be used to proactively inform MIPS eligible clinicians about the timeframe they would need to submit data, which would be provided to the group during the performance period. We intend to use the voluntary registration process as a means to provide additional educational materials that are targeted and tailored to such groups; and if technically feasible, provide such groups with access to additional toolkits. We believe it is important for groups to have such information in advance in order to prepare for the submission of data. Also, we note that the voluntary registration process differs from the registration process required for groups electing to submit data via the CMS Web Interface, such that groups registering on a voluntary basis would be able to opt out of group-level reporting and/or modify their associated settings such as the chosen submission mechanism at any time. The participation of a group in MIPS via a data submission mechanism other than the CMS Web Interface or a group electing to administer the CAHPS for MIPS survey would not be contingent upon engagement in the voluntary registration process. Whether or not a group elects to participate in voluntary registration, a group must meet all of the requirements pertaining to groups. We intend to issue further information regarding the voluntary registration process for groups in subregulatory guidance.
Section 1848(q)(5)(I) of the Act establishes the use of voluntary virtual groups for certain assessment purposes. The statute requires the establishment and implementation of a process that allows an individual MIPS eligible clinician or a group consisting of not more than 10 MIPS eligible clinicians to elect to form a virtual group with at least one other such individual MIPS eligible clinician or group of not more than 10 MIPS eligible clinicians for a performance period of a year. As determined in statute, individual MIPS eligible clinicians and groups forming virtual groups are required to make such election prior to the start of the applicable performance period under MIPS and cannot change their election during the performance period. As discussed in section II.E.4. of the proposed rule, we proposed that the performance period would be based on a calendar year.
As we assessed the timeline for the establishment and implementation of virtual groups and applicable election process and requirements for the first performance period under MIPS, we identified significant barriers regarding the development of a technological infrastructure required for successful implementation and the operationalization of such provisions that would negatively impact the execution of virtual groups as a conducive option for MIPS eligible clinicians or groups. The development of an electronic system before policies are finalized poses several risks, particularly relating to the impediments of completing and adequately testing the system before execution and assuring that any change in policy made during the rulemaking process are reflected in the system and operationalized accordingly. We believe that it would be exceedingly difficult to make a successful system to support the implementation of virtual groups, and given these factors, such implementation would compromise not only the integrity of the system, but the intent of the policies.
Additionally, we recognize that it would be impossible for us to develop an entire infrastructure for electronic transactions pertaining to an election process, reporting of data, and performance measurement before the start of the performance period beginning on January 1, 2017. Moreover, the actual implementation timeframe would be more condensed given that the development, testing, and execution of such a system would need to be completed months in advance of the beginning of the performance period in order to provide MIPS eligible clinicians and groups with an election period.
During the implementation and ongoing functionality of other programs such as PQRS, Medicare EHR Incentive Program, and VM, we received feedback from stakeholders regarding issues they encountered when submitting reportable data for these programs. With virtual groups as a new option, we want to minimize potential issues for end-users and implement a system that encourages and enables MIPS eligible clinicians and groups to participate in a virtual group. A web-based registration process, which would simplify and streamline the process for participation, is our preferred approach. Given the aforementioned dynamics discussed in this section, implementation for the CY 2017 performance period is infeasible as a result of the insufficient timeframe to develop a web-based registration process. We have assessed alternative approaches for the first year only, such as an email registration process, but believe that there are limitations and potential risks for numerous errors, such as submitted information being incomplete or not in the required format. A manual verification process would cause a significant delay in verifying registration due to the lack of an automated system to ensure the accuracy of the type of information submitted that is required for registration. We believe that an email registration process could become
The following is a summary of the comments we received regarding our intention to implement virtual groups for the CY 2018 performance period and factors we should consider regarding the establishment and implementation of virtual groups.
A few commenters recommended the following minimum standards for members of a virtual group: Have mutual interest in quality improvement; care for similar populations; and be responsible for the impact of their decisions on the whole group. A few commenters suggested that virtual groups should not have their performance ratings compared to other virtual groups, but instead, virtual groups should have their performance ratings compared to their annual performance rating during the initial implementation of virtual groups given that each virtual group's clinicians and beneficiaries may have varying risk preventing a direct comparison.
As we develop requirements applicable to virtual groups, we will also consider the ways in which virtual groups will each have unique characteristic compositions and varying patient populations and how the performance of virtual groups will be assessed, scored, and compared. We are committed to pursuing the active engagement of the stakeholders throughout the process of establishing and implementing virtual groups.
Another commenter indicated that the implementation of virtual groups could be unsuccessful based on the following factors: There is no necessary consistency in the nomenclature and methods used by different health IT vendors and developers, which would prevent prospective virtual group members from correctly understanding the degree and nature of the differences in approaches regarding data collection and submission; any vendor-related issues would be combined in unpredictable ways within virtual groups, causing the datasets to not correspond categorically and having inconsistent properties among the datasets; there is the prospect of a mismatch of properties for virtual group members on assessed measures, where neither excellence nor laggardly work would be clearly visible; and there is a risk of a practice joining a virtual group with “free riders,” which would result in a churning of membership and a serious loss of year-to-year comparison capabilities. In order to address such issues, the commenter recommended that CMS develop a system that includes the capability for clinicians and groups to participate in a service similar to online dating service applications that would allow clinicians and groups to use self-identifying descriptors to select their true peers within similar CEHRT.
A few commenters requested clarification regarding the approved methods for submitting and aggregating disparate clinician data for virtual groups, and whether or not new clinicians should be included in virtual groups if they have not been part of the original TIN throughout the reporting year.
We thank the commenters for their input regarding our intention to implement virtual groups for the CY 2018 performance period and factors we should consider regarding the establishment and implementation of virtual groups. We intend to explore the types of requirements pertaining to virtual groups, including, but not limited to, defining a group identifier for virtual groups, establishing the reporting requirements for virtual groups, identifying the submission mechanisms available for virtual group participation, and establishing methodologies for how virtual group performance will be assessed and scored. In addition, during the CY 2017 performance period, we will be convening a user group of stakeholders to receive further input on the factors CMS should consider in establishing the requirements for virtual groups and identify mechanisms for the implementation of virtual groups in future years.
Section 1848(q)(5)(I)(iii)(I) of the Act provides that the election process must occur prior to the performance period and may not be changed during the performance period. We proposed to establish an election process that would end on June 30 of a calendar year preceding the applicable performance period. During the election process, we proposed that individual MIPS eligible clinicians and groups electing to be a virtual group would be required to register in order to submit reportable data. Virtual groups would be assessed across all four MIPS performance categories. In future rulemaking, we will address all elements relating to the election process and outline the criteria and requirements regarding the formation of virtual groups. We solicited public comments on this proposal.
The following is summary of the comments we received regarding our proposals that apply to virtual groups, including: The establishment of an election process that would end on June 30 of a calendar year preceding the applicable performance period; the requirement of individual MIPS eligible clinicians and groups electing to be a virtual group to register in order to submit reportable data; and the assessment of virtual groups across all four MIPS performance categories.
After consideration of the public comments we received, and with the delay of virtual group implementation, we are not finalizing our proposal to establish a virtual group election process that would end on June 30 for the CY 2017 performance period; the proposed requirement of individual MIPS eligible clinicians and groups electing to be a virtual group to register in order to submit reportable data; or the proposed assessment of virtual groups across all four MIPS performance categories.
MIPS incorporates many of the requirements of several programs into a single, comprehensive program. This consolidation includes key policy goals as common themes across multiple categories such as quality improvement, patient and family engagement, and care coordination through interoperable health information exchange. However, each of these legacy programs included different eligibility requirements, reporting periods, and systems for clinicians seeking to participate. This means that we must balance potential impacts of changes to systems and technical requirements to successfully synchronize reporting, as noted in the discussion regarding the definition of a MIPS eligible clinician in the proposed rule (81 FR 28173). We must take operational feasibility, systems impacts, and education and outreach on participation into account in developing technical requirements for participation. One area where this is particularly important is in the definition of a performance period.
MIPS applies to payments for items and services furnished on or after January 1, 2019. Section 1848(q)(4) of the Act requires the Secretary to establish a performance period (or periods) for a year (beginning with 2019). Such performance period (or periods) must begin and end prior to such year and be as close as possible to such year. In addition, section 1848(q)(7) of the Act provides that, not later than 30 days prior to January 1 of the applicable year, the Secretary must make available to each MIPS eligible clinician the MIPS adjustment (and, as applicable, the additional MIPS adjustment) applicable to the MIPS eligible clinician for items and services furnished by the MIPS eligible clinician during the year.
We considered various factors when developing the policy for the MIPS performance period. Stakeholders have stated that having a performance period as close to when payments are adjusted is beneficial, even if such period would be less than a year. We have also received feedback from stakeholders that they prefer having a 1 year performance period and have further suggested that the performance period start during the calendar year (for example, having the performance period occurring from July 1 through June 30). We additionally considered operational factors, such as that a 1 year performance period may be beneficial for all four performance categories because many measures and activities cannot be reported in a shorter time frame. We also considered that data submission activities and claims for items and services furnished during the 1 year performance period (which could be used for claims- or administrative claims-based quality or cost measures) may not be fully processed until the following year.
These circumstances will require adequate lead time to collect performance data, assess performance, and compute the MIPS adjustment so the applicable MIPS adjustment can be made available to each MIPS eligible clinician at least 30 days prior to when the MIPS payment adjustment is applied each year. For 2019, these actions will occur during 2018. In other payment systems, we have used claims that are processed within a specified time period after the end of the performance period, such as 60 or 90 days, for assessment of performance and application of the MIPS payment adjustment. For MIPS, we proposed at § 414.1325(g)(2) to use claims that are processed within 90 days, if operationally feasible, after the end of the performance period for purposes of assessing performance and computing the MIPS payment adjustment. We proposed that if we determined that it is not operationally feasible to have a claims data run-out for the 90-day timeframe, then we would utilize a 60-day duration in the calendar year immediately following the performance period.
This proposal does not affect the performance period per se, but rather the deadline by which claims for items and services furnished during the performance period need to be processed for those items and services to be included in our calculation. To the extent that claims are used for submitting data on MIPS measures and activities to us, such claims would have to be processed by no later than 90 days after the end of the applicable performance period, in order for information on the claims to be included in our calculations. As noted in this section, if we determined that it is not operationally feasible to have a claims data run-out for the 90-day timeframe, then we would utilize a 60-day duration. As an alternative to our proposal, we also considered using claims that are paid within 60 days after 2017, for assessment of performance and application of the MIPS payment adjustment for 2019. We solicited comments on both approaches.
Given the need to collect and process information, we proposed at § 414.1320 that for 2019 and subsequent years, the performance period under MIPS would be the calendar year (January 1 through December 31) 2 years prior to the year in which the MIPS adjustment is applied. For example, the performance period for the 2019 MIPS adjustment would be the full CY 2017, that is, January 1, 2017 through December 31, 2017. We proposed to use the 2017 performance year for the 2019 MIPS payment adjustment consistent with other CMS programs. This approach allows for a full year of measurement and sufficient time to base adjustments on complete and accurate information.
For individual MIPS eligible clinicians and groups with less than 12 months of performance data to report, such as when a MIPS eligible clinician switches practices during the performance period or when a MIPS eligible clinician may have stopped practicing for some portion of the performance period (for example, a MIPS eligible clinician who is on family leave, or has an illness), we proposed that the individual MIPS eligible clinician or group would be required to report all performance data available from the performance period. Specifically, if a MIPS eligible clinician is reporting as an individual, they would report all partial year performance data. Alternatively, if the MIPS eligible clinician is reporting with a group, then the group would report all
Under this approach, MIPS eligible clinicians with partial year performance data could achieve a positive, neutral, or negative MIPS adjustment based on their performance data. We proposed this approach to incentivize accountability for all performance during the performance period. We also believe these policies would help minimize the impact of partial year data. First, MIPS eligible clinicians with volume below the low-volume threshold would be excluded from any MIPS payment adjustments. Second, MIPS eligible clinicians who report measures, yet have insufficient sample size, would not be scored on those measures and activities. Refer to section II.E.6. of this final rule with comment period for more information on scoring.
To potentially refine this proposal in future years, we solicited comments on methods to accurately identify MIPS eligible clinicians with less than a 12-month reporting period, notwithstanding common and expected absences due to illness, vacation, or holiday leave. Reliable identification of these MIPS eligible clinicians would allow us to analyze the characteristics of MIPS eligible clinicians' patient population and better understand how a reduced reporting period impacts performance.
We also solicited public comment on an alternative approach for future years for assessment of individual MIPS eligible clinicians with less than 12 months of performance data in the performance year. For example, if we can identify such MIPS eligible clinicians and confirm there are data issues that led to invalid performance calculations, then we could score the MIPS eligible clinician with a final score equal to the performance threshold, which would result in a zero MIPS payment adjustment. We note this approach would not assess a MIPS eligible clinicians' performance for partial-year performance data. We do not believe that consideration of partial year performance is necessary for assessment of groups, which should have adequate coverage across MIPS eligible clinicians to provide valid performance calculations.
We also solicited comment on reasonable thresholds for considering performance that is less than 12 months. For example, we expect that some MIPS eligible clinicians will take leave related to illness, vacation, and holidays. We would not anticipate applying special policies for lack of performance related to these common and expected absences assuming MIPS eligible clinicians' quality reporting includes measures with sufficient sample size to generate valid and reliable scores. We solicited comment on how to account for MIPS eligible clinicians with extended leave that may affect measure sample size.
We solicited comments on these proposals and approaches. The following is summary of the comments we received regarding our proposals for the MIPS performance period.
We believe the flexibilities we are providing in our modified proposal discussed above will provide time for stakeholders to engage in further education about the new requirements and make the necessary modifications to their practices to accommodate reporting under the MIPS. We note that the continuous 90-day period of time required for reporting can occur at any point within the CY 2017 performance period, up until and including October 2, 2017, which is the last date that the continuous 90-day period of time required for reporting can begin and end within the CY 2017 performance period.
For the second year under the MIPS, we are finalizing our proposal to require reporting and performance assessment
The commenters suggested various dates for the transitional or phase-in period such as: January 1, 2017 through June 30, 2017, July 1, 2017 through December 31, 2017, allowing MIPS eligible clinicians to select a 6-month performance period or allowing MIPS eligible clinicians to use the full calendar year with an optional look-back to January 1 in 2017. The commenters requested that CMS provide technical assistance and a submission verification process during the transition period.
After consideration of the comments we received regarding the MIPS performance period, we are finalizing a modification of our proposal of a 12-month performance period that occurs 2 years prior to the applicable payment year. For the transition year of MIPS, we believe it is important that we provide flexibility to MIPS eligible clinicians as they familiarize themselves with MIPS requirements while maintaining reliability. Therefore, we are finalizing at § 414.1320(a)(1) that for purposes of the 2019 MIPS payment year, for all performance categories and submission mechanisms except for the cost performance category and data for the quality performance category reported through the CMS Web Interface, for the CAHPS for MIPS survey, and for the all-cause hospital readmission measure, the performance period under MIPS is a minimum of a continuous 90-day period within CY 2017, up to and including the full CY (January 1, 2017 through December 31, 2017). Thus, MIPS eligible clinicians will only need to report for a minimum of a continuous 90-day period within CY 2017, for the majority of the
For groups that elect to utilize the CMS Web Interface or report the CAHPS for MIPS survey, we note that these submission mechanisms utilize certain assignment and sampling methodologies that are based on a 12-month period. In addition, administrative claims-based measures (this includes all of the cost measures and the all-cause readmission measure) are based on attributed population using the 12-month performance period. Accordingly, we are finalizing at § 414.1320(a)(2) that for purposes of the 2019 MIPS payment year, for data reported through the CMS Web Interface or the CAHPS for MIPS survey and administrative claims-based cost and quality measures, the performance period under MIPS is CY 2017 (January 1, 2017 through December 31, 2017). Please note that, unless otherwise stated, any reference in this final rule with comment period to the “CY 2017 performance period” is intended to be an inclusive reference to all performance periods occurring during CY 2017.
Additionally, we are finalizing at § 414.1320(b)(1) that for purposes of the 2020 MIPS payment year, the performance period for the quality and cost performance categories is CY 2018 (January 1, 2018 through December 31, 2018). For the improvement activities and advancing care information performance categories, we are finalizing the same approach for the 2020 MIPS payment year that we will have in place for the transition year of MIPS. Specifically, we are finalizing at § 414.1320(b)(2) that for purposes of the 2020 MIPS payment year, the performance period for the improvement activities and advancing care information performance categories is a minimum of a continuous 90-day period within CY 2018, up to and including the full CY 2018 (January 1, 2018 through December 31, 2018).
We are also finalizing a modification to our proposal, which was to use claims run-out data that are processed within 90 days, if operationally feasible, after the end of the performance period for purposes of assessing performance and computing the MIPS payment adjustment. Specifically, we are finalizing at § 414.1325(f)(2) to use claims with dates of service during the performance period that must be processed no later than 60 days following the close of the performance period for purposes of assessing performance and computing the MIPS payment adjustment.
Lastly, we are finalizing our proposal that individual MIPS eligible clinicians or groups who report less than 12 months of data (due to family leave, etc.) would be required to report all performance data available from the applicable performance period (for example, to any 90-day period).
Section 1848(q)(2)(A) of the Act requires the Secretary to use four performance categories in determining each MIPS eligible clinician's final score under the MIPS: Quality; cost; improvement activities; and advancing care information. Section 1848(q)(2)(B) of the Act, subject to section 1848(q)(2)(C) of the Act, describes the measures and activities that, for purposes of the MIPS performance standards, must be specified under each performance category for a performance period.
Section 1848(q)(2)(B)(i) of the Act describes the measures and activities that must be specified under the MIPS quality performance category as the quality measures included in the annual final list of quality measures published under section 1848(q)(2)(D)(i) of the Act and the list of quality measures described in section 1848(q)(2)(D)(vi) of the Act used by QCDRs under section 1848(m)(3)(E) of the Act. Under section 1848(q)(2)(C)(i) of the Act, the Secretary must, as feasible, emphasize the application of outcome-based measures in applying section 1848(q)(2)(B)(i) of the Act. Under section 1848(q)(2)(C)(iii) of the Act, the Secretary may also use global measures, such as global outcome measures and population-based measures, for purposes of the quality performance category. Section 1848(q)(2)(B)(ii) of the Act describes the measures and activities that must be specified under the cost performance category as the measurement of cost for the performance period under section 1848(p)(3) of the Act, using the methodology under section 1848(r) of the Act as appropriate, and, as feasible and applicable, accounting for the cost of drugs under Part D.
Section 1848(q)(2)(C)(ii) of the Act allows the Secretary to use measures from other CMS payment systems, such as measures for inpatient hospitals, for purposes of the quality and cost performance categories, except that the Secretary may not use measures for hospital outpatient departments, other than in the case of items and services furnished by emergency physicians, radiologists, and anesthesiologists. In the proposed rule, we solicited comment on how it might be feasible and when it might be appropriate to incorporate measures from other systems into MIPS for clinicians that work in facilities such as inpatient hospitals. For example, it may be appropriate to use such measures when other applicable measures are not available for individual MIPS eligible clinicians or when strong payment incentives are tied to measure performance, either at the facility level or with employed or affiliated MIPS eligible clinicians.
Section 1848(q)(2)(B)(iii) of the Act describes the measures and activities that must be specified under the improvement activities performance category as improvement activities under subcategories specified by the Secretary for the performance period, which must include at least the subcategories specified in section 1848(q)(2)(B)(iii)(I) through (VI) of the Act. Section 1848(q)(2)(C)(v)(III) of the Act defines a improvement activities as an activity that relevant eligible clinician organizations and other relevant stakeholders identify as improving clinical practice or care delivery and that the Secretary determines, when effectively executed, is likely to result in improved outcomes. Section 1848(q)(2)(B)(iii) of the Act
Section 1848(q)(2)(B)(iv) of the Act describes the measures and activities that must be specified under the advancing care information performance category as the requirements established for the performance period under section 1848(o)(2) for determining whether an eligible clinician is a meaningful EHR user.
As discussed in the proposed rule (81 FR 28173), section 1848(q)(2)(C)(iv) of the Act requires the Secretary to give consideration to the circumstances of non-patient facing MIPS eligible clinicians in specifying measures and activities under the MIPS performance categories and allows the Secretary, to the extent feasible and appropriate, to take those circumstances into account and apply alternative measures or activities that fulfill the goals of the applicable performance category. In doing so, the Secretary is required to consult with non-patient facing professionals.
Section 101(b) of MACRA amends certain provisions of section 1848(k), (m), (o), and (p) of the Act to generally provide that the Secretary will carry out such provisions in accordance with section 1848(q)(1)(F) of the Act for purposes of MIPS. Section 1848(q)(1)(F) of the Act provides that, in applying a provision of section 1848(k), (m), (o), and (p) of the Act for purposes of MIPS, the Secretary must adjust the application of the provision to ensure that it is consistent with the MIPS requirements and must not apply the provision to the extent that it is duplicative with a MIPS provision.
We did not request comments on this section, but we did receive a few comments which are summarized below.
Some commenters suggested that instead of focusing on four performance categories simultaneously, CMS should focus on interoperability and making that functionality fully workable before moving on to the next step.
One commenter was very concerned that the cumulative effect of four sets of largely separate measures and activities, scoring methodologies, and reporting requirements could result in more administrative work for practices, not less, and encouraged CMS to consider additional ways to reduce the MIPS reporting burden for all practices such as reducing the number of required measures or activities in each MIPS performance category, lowering measure thresholds, establishing consistent definitions (such as for “small practices”) across categories, and providing more opportunities for “partial credit.” Other commenters urged CMS to take every possible step to dramatically simplify provisions and requirements, and to revise and develop practice-focused communications to reduce any remaining perceived complexity.
Another commenter agreed with the level of flexibility CMS has proposed for MIPS eligible clinicians by allowing them to choose the specific quality performance measures most applicable to their practice and stated that CMS should design the requirements within the performance categories to work in concert with each other to ensure meaningful quality measurement. Some commenters asked if there will be interoperability between the four MIPS performance categories.
Further, we are required by statute to utilize the four performance categories to determine the final score. We appreciate the support and agree that the goal of the MIPS program is that the four performance categories should work in concert with one another. In addition, as discussed in section II.E.5. of this final rule with comment period, we have modified our policies to have the four performance categories work more in concert with one another.
We have considered the comments received and will take them into consideration in the future development of performance feedback through separate notice-and-comment rulemaking.
We proposed at § 414.1325(a) that individual MIPS eligible clinicians and groups would be required to submit data on measures and activities for the quality, improvement activities and advancing care information performance categories. We did not propose at § 414.1325(f) any data submission requirements for the cost performance category and for certain quality measures used to assess performance on the quality performance category and for certain activities in the improvement activities performance category. For the cost performance category, we proposed that each individual MIPS eligible clinician's and group's cost performance would be calculated using administrative claims data. As a result, individual MIPS eligible clinicians and groups would not be required to submit any additional information for the cost performance category. In addition, we would be using administrative claims data to calculate performance on a subset of the MIPS quality measures and the improvement activities performance category, if technically feasible. For this subset of quality measures and improvement activities, MIPS eligible clinicians and groups would not be required to submit additional information. For individual clinicians and groups that are not MIPS eligible clinicians, such as physical therapists, but elect to report to MIPS, we would calculate administrative claims cost measures and quality measures, if data are available. We proposed multiple data submission mechanisms for MIPS as outlined in Tables 1 and 2 in the proposed rule (81 FR 28182) and the final policies identified in Tables 3 and 4 in this final rule with comment period, to provide MIPS eligible clinicians with flexibility to submit their MIPS measures and activities in a manner that best accommodates the characteristics of their practice. We note that other terms have been used for these submission mechanisms in earlier programs and in industry.
We proposed at § 414.1325(d) that MIPS eligible clinicians and groups may elect to submit information via multiple mechanisms; however, they must use the same identifier for all performance categories and they may only use one submission mechanism per performance category. For example, a MIPS eligible clinician could use one submission mechanism for sending quality measures and another for sending improvement activities data, but a MIPS eligible clinician could not use two submission mechanisms for a single performance category such as submitting three quality measures via claims and three quality measures via registry. We believe the proposal to allow multiple mechanisms, while restricting the number of mechanisms per performance category, offers flexibility without adding undue complexity.
For individual MIPS eligible clinicians, we proposed at § 414.1325(b), that an individual MIPS eligible clinician may choose to submit their quality, improvement activities, and advancing care information performance category data using qualified registry, QCDR, or EHR submission mechanisms. Furthermore, we proposed at § 414.1400 that a qualified registry, health IT vendor, or QCDR could submit data on behalf of the MIPS eligible clinician for the three performance categories: Quality, improvement activities, and advancing care information. In the proposed rule (81 FR 28280), we expanded third party intermediaries' capabilities by allowing them to submit data and activities for quality, improvement activities, and advancing care information performance categories. Additionally, we proposed at § 414.1325(b)(4) and (5) that individual MIPS eligible clinicians may elect to report quality information via Medicare Part B claims and their improvement activities and advancing care information performance category data through attestation.
For groups that are not reporting through the APM scoring standard, we proposed at § 414.1325(c) that these groups may choose to submit their MIPS quality, improvement activities, and advancing care performance category information data using qualified registry, QCDR, EHR, or CMS Web Interface (for groups of 25+ MIPS eligible clinicians) submission mechanisms. Furthermore, we proposed at § 414.1400 that a qualified registry, health IT vendor that obtains data from a MIPS eligible clinician's CEHRT, or QCDR could submit data on behalf of the group for the three performance categories: Quality, improvement activities, and advancing care information. Additionally, we proposed that groups may elect to submit their improvement activities or advancing care information performance category data through attestation.
For those MIPS eligible clinicians participating in an APM that uses the APM scoring standard, we refer readers to the proposed rule (81 FR 28234), which describes how certain APM Entities submit data to MIPS, including separate approaches to the quality and cost performance categories for APMs.
We proposed one exception to the requirement for one reporting mechanism per performance category. Groups that elect to include CAHPS for MIPS survey as a quality measure must use a CMS-approved survey vendor. Their other quality information may be reported by any single one of the other proposed submission mechanisms.
While we proposed to allow MIPS eligible clinicians and groups to submit data for different performance categories via multiple submission mechanisms, we encouraged MIPS eligible clinicians to submit MIPS information for the improvement activities and advancing care information performance categories through the same reporting mechanism that is used for quality reporting. We believe it would reduce administrative burden and would simplify the data submission process for MIPS eligible clinicians by having a single reporting mechanism for all three performance categories for which MIPS eligible clinicians would be required to submit data: Quality, improvement activities, and advancing care information performance category information. However, we were concerned that not all third party entities would be able to implement the changes necessary to support reporting on all performance categories in the transition year. We solicited comments for future rulemaking on whether we should propose requiring health IT vendors, QCDRs, and qualified registries to have the capability to submit data for all MIPS performance categories.
As noted at (81 FR 28181), we proposed that MIPS eligible clinicians may report measures and activities using different submission methods for each performance category if they choose for reporting data for the CY 2017 performance period. As we gain experience under MIPS, we anticipate that in future years it may be beneficial for, and reduce burden on MIPS eligible clinicians and groups, to require data for multiple performance categories to come through a single submission mechanism.
Further, we will be flexible in implementing MIPS. For example, if a MIPS eligible clinician does submit data via multiple submission mechanisms (for example, registry and QCDR), we would score all the measures in each submission mechanism and use the highest performance score for the MIPS eligible clinician or group as described at (81 FR 28247). However, we would not be blending measure results across submission mechanisms. We encourage MIPS eligible clinicians to report data for a given performance category using a single data submission mechanism.
Finally, section 1848(q)(1)(E) of the Act requires the Secretary to encourage the use of QCDRs under section 1848(m)(3)(E) of the Act in carrying out MIPS. Section 1848(q)(5)(B)(ii)(I) of the Act requires the Secretary, under the final score methodology, to encourage MIPS eligible clinicians to report on applicable measures with respect to the quality performance category through the use of CEHRT and QCDRs. We note that the proposed rule used the term CEHRT and certified health IT in different contexts. For an explanation of these terms and contextual use within
We have multiple policies to encourage the usage of QCDRs and CEHRT. In part, we are promoting the use of CEHRT by awarding bonus points in the quality scoring section for measures gathered and reported electronically via the QCDR, qualified registry, CMS Web Interface, or CEHRT submission mechanisms see the proposed rule (81 FR 28247). By promoting the use of CEHRT through various submission mechanisms, we believe MIPS eligible clinicians have flexibility in implementing electronic measure reporting in a manner which best suits their practice.
To encourage the use of QCDRs, we have created opportunities for QCDRs to report new and innovative quality measures. In addition, several improvement activities emphasize QCDR participation. Finally, we allow for QCDRs to report data on all MIPS performance categories that require data submission and hope this will become a viable option for MIPS eligible clinicians. We believe these flexible options will allow MIPS eligible clinicians to more easily meet the submission criteria for MIPS, which in turn will positively affect their final score.
We requested comments on these proposals.
The following is summary of the comments we received on our proposals regarding MIPS data submission mechanisms.
Additionally, in section II.E.9.(b). of this final rule with comment period, we have expanded health IT vendors' opportunities by allowing health IT vendors to submit data on measures, activities, or objectives for any of the following MIPS performance categories: (i) Quality; (ii) improvement activities; or (iii) advancing care information. In addition, the health IT vendor submitting data on behalf of a MIPS eligible clinician or group would be required to obtain data from the MIPS eligible clinician's certified EHR technology. However, the health IT vendor would be able to submit the same information the qualified registry is able to. Therefore, we do not believe there is a disparity between health IT vendors and qualified registry's quality data submission capabilities.
After consideration of the comments on our proposals regarding the MIPS data submission mechanisms, we are modifying the data submission mechanisms at § 414.1325. We will not be finalizing the data submission mechanism of administrative claims for the improvement activities performance category, as it is not technically feasible at this time. All other data submission mechanisms will be finalized as proposed. Specifically, we are finalizing at § 414.1325(a) that MIPS eligible clinicians and groups must submit measures, objectives, and activities for the quality, improvement activities, and advancing care information performance categories.
Refer to Tables 3 and 4 of this final rule with comment period for the finalized data submission mechanisms. Table 3 contains a summary of the data submission mechanisms for individual MIPS eligible clinicians that we are finalizing at § 414.1325(b) and (e). Table 4 contains a summary of the data submission mechanisms for groups that are not reporting through an APM that we are finalizing at § 414.1325(c) and § 414.1325(e). Furthermore, we are finalizing our proposal at § 414.1325(d) that except for groups that elect to report the CAHPS for MIPS survey, MIPS eligible clinicians and groups may elect to submit information via multiple mechanisms; however, they must use the same identifier for all performance categories and they may only use one submission mechanism per performance category. In addition, we are finalizing at § 414.1305 the following definitions as proposed: (1) Attestation means a secure mechanism, specified by CMS, with respect to a particular performance period, whereby a MIPS eligible clinician or group may submit the required data for the advancing care information or the improvement activities performance categories of MIPS in a manner specified by CMS; (2) CMS-approved survey vendor means a survey vendor that is approved by CMS for a particular performance period to administer the CAHPS for MIPS survey and to transmit survey measures data to CMS; and (3) CMS Web Interface means a web product developed by CMS that is used by groups that have elected to utilize the CMS Web Interface to submit data on the MIPS measures and activities.
For the submission mechanisms described in the proposed rule (81 FR 28181), we proposed a submission deadline whereby all associated data for all performance categories must be submitted. In establishing the submission deadlines, we took into account multiple considerations, including the type of submission mechanism, the MIPS performance period, and stakeholder input and our experiences under the submission deadlines for the PQRS, VM, and Medicare EHR Incentive Programs.
Historically, under the PQRS, VM, or Medicare EHR Incentive Programs, the submission of data occurred after the close of the performance periods. Our experience has shown that allowing for the submission of data after the close of the performance period provides either the MIPS eligible clinician or the third party intermediary time to ensure the data they submit to us is valid, accurate and has undergone necessary data quality checks. Stakeholders have also stated that they would appreciate the ability to submit data to us on a more frequent basis so they can receive feedback more frequently throughout the performance period. We also note that, as described in the proposed rule (81 FR 28179), the MIPS performance period for payments adjusted in 2019 is CY 2017 (January 1 through December 31).
Based on the factors noted, we proposed at § 414.1325(e) that the data submission deadline for the qualified registry, QCDR, EHR, and attestation submission mechanisms would be March 31 following the close of the performance period. We anticipate that the submission period would begin January 2 following the close of the performance period. For example, for the first MIPS performance period, the data submission period would occur from January 2, 2018, through March 31, 2018. We note that this submission period is the same time frame as what is currently available to EPs and group practices under PQRS. We were interested in receiving feedback on whether it is advantageous to either (1) have a shorter time frame following the close of the performance period, or (2) have a submission period that would occur throughout the performance period, such as bi-annual or quarterly submissions; and (3) whether January 1 should also be included in the submission period. We requested comments on these items.
We further proposed that for the Medicare Part B claims submission mechanism, the submission deadline would occur during the performance period with claims required to be processed no later than 90 days following the close of the performance period. Lastly, for the CMS Web Interface submission mechanism, the submission deadline will occur during an 8-week period following the close of the performance period that will begin no earlier than January 1 and end no later than March 31. For example, the CMS Web Interface submission period could span an 8-week timeframe beginning January 16 and ending March 13. The specific deadline during this timeframe will be published on the CMS Web site.
We requested comments on these proposals.
The following is a summary of the comments we received on our proposals regarding MIPS submission deadlines.
In addition, we do not believe that allowing these various submission mechanisms impacts the ability to create reliable and accurate measure benchmarks. We discuss our policies related to measure benchmarks in more detail in section II.E.6.e. of this final rule with comment period.
After consideration of the comments received on the proposals regarding MIPS submission deadlines, we are finalizing the submission deadlines as proposed with one modification. Specifically, we are finalizing at § 414.1325(f) the data submission deadline for the qualified registry, QCDR, EHR, and attestation submission mechanisms as March 31 following the close of the performance period. The submission period will begin prior to January 2 following the close of the performance period, if technically feasible. For example, for the first MIPS performance period, the data submission period will occur prior to January 2, 2018, through March 31, 2018, if technically feasible. If it is not technically feasible to allow the submission period to begin prior to January 2 following the close of the performance period, the submission period will occur from January 2 through March 31 following the close of the performance period. In any case, the final deadline will remain March 31, 2018.
We further finalize at § 414.1325(f)(2) that for the Medicare Part B claims submission mechanism, the submission deadline must be on claims with dates of service during the performance period that must be processed no later than 60 days following the close of the performance period. Lastly, for the CMS Web Interface submission mechanism, we are finalizing at § 414.1325(f)(3) the submission deadline must be an 8-week period following the close of the performance period that will begin no earlier than January 1, and end no later than March 31. For example, the CMS Web Interface submission period could span an 8-week timeframe beginning January 16 and ending March 13. The specific deadline during this timeframe will be published on the CMS Web site.
The MIPS program is one piece of the broader health care infrastructure needed to reform the health care system and improve health care quality, efficiency, and patient safety for all Americans. We seek to balance the sometimes competing considerations of the health system and minimize burdens on health care providers given the short timeframe available under the MACRA for implementation. Ultimately, MIPS should, in concert with other provisions of the Act, support health care that is patient-centered, evidence-based, prevention-oriented, outcome driven, efficient, and equitable.
Under MIPS, clinicians are incentivized to engage in improvement measures and activities that have a proven impact on patient health and safety and are relevant to their patient population. We envision a future state where MIPS eligible clinicians will be seamlessly using their certified health IT to leverage advanced clinical quality measurement to manage patient populations with the least amount of workflow disruption and reporting burden. Ensuring clinicians are held accountable for patients' transitions across the continuum of care is imperative. For example, when a patient is discharged from an emergency department (ED) to a primary care physician office, health care providers on both sides of the transition should have a shared incentive for a seamless transition. Clinicians may also be working with a QCDR to abstract and report quality measures to CMS and commercial payers and to track patients longitudinally over time for quality improvement.
Ideally, clinicians in the MIPS program will have accountability for quality and cost measures that are related to one another and will be engaged in improvement activities that directly help them improve in both specialty-specific clinical practice and more holistic areas (for example, patient experience, prevention, population health). The cost performance category will provide clinicians with information needed to delivery efficient, effective, and high-value care. Finally, MIPS eligible clinicians will be using CEHRT and other tools which leverage interoperable standards for data capture, usage, and exchange in order to facilitate and enhance patient and family engagement, care coordination among diverse care team members, and continuous learning and rapid-cycle improvement leveraging advanced quality measurement and safety initiatives.
One of our goals in the MIPS program is to use a patient-centered approach to program development that will lead to better, smarter, and healthier care. Part of that goal includes meaningful
• Measuring performance on measures that are relevant and meaningful.
• Maximizing the benefits of CEHRT.
• Flexible scoring that recognizes all of a MIPS eligible clinician's efforts above a minimum level of effort and rewards performance that goes above and beyond the norm.
• Measures that are built around real clinical workflows and data captured in the course of patient care activities.
• Measures and scoring that can discern meaningful differences in performance in each performance category and collectively between low and high performers.
Sections 1848(q)(1)(A)(i) and (ii) of the Act require the Secretary to develop a methodology for assessing the total performance of each MIPS eligible clinician according to performance standards and, using that methodology, to provide for a final score for each MIPS eligible clinician. Section 1848(q)(2)(A)(i) of the Act requires us to use the quality performance category in determining each MIPS eligible clinician's final score, and section 1848(q)(2)(B)(i) of the Act describes the measures and activities that must be specified under the quality performance category.
The statute does not specify the number of quality measures on which a MIPS eligible clinician must report, nor does it specify the amount or type of information that a MIPS eligible clinician must report on each quality measure. However, section 1848(q)(2)(C)(i) of the Act requires the Secretary, as feasible, to emphasize the application of outcomes-based measures.
Sections 1848(q)(1)(E) of the Act requires the Secretary to encourage the use of QCDRs, and section 1848(q)(5)(B)(ii)(I) of the Act requires the Secretary to encourage the use of CEHRT and QCDRs for reporting measures under the quality performance category under the final score methodology, but the statute does not limit the Secretary's discretion to establish other reporting mechanisms.
Section 1848(q)(2)(C)(iv) of the Act generally requires the Secretary to give consideration to the circumstances of non-patient facing MIPS eligible clinicians and allows the Secretary, to the extent feasible and appropriate, to apply alternative measures or activities to such clinicians.
Previously, the PQRS, which is a pay-for-reporting program, defined requirements for satisfactory reporting and satisfactory participation to earn payment incentives or to avoid a PQRS payment adjustment EPs could choose from a number of reporting mechanisms and options. Based on the reporting option, the EP had to report on a certain number of measures for a certain portion of their patients. In addition, the measures had to span a set number of National Quality Strategy (NQS) domains, information related to the NQS can be found at
MIPS, in contrast to PQRS, is not a pay-for-reporting program, and we proposed that it would not have a “satisfactory reporting” requirement. However, to develop an appropriate methodology for scoring the quality performance category, we believe that MIPS needs to define the expected data submission criteria and that the measures need to meet a data completeness standard. In the proposed rule (81 FR 28184), we proposed the minimum data submission criteria and data completeness standard for the MIPS quality performance category for the submission mechanisms that were discussed in the proposed rule (81 FR 28181), as well as benchmarks against which eligible clinicians' performance would be assessed. The scoring methodology discussed in the proposed rule (81 FR 28220) would adjust the quality performance category scores based on whether or not an individual MIPS eligible clinician or group met these criteria and how their performance compared against the benchmarks.
In the MIPS and APMs RFI, we requested feedback on numerous provisions related to data submission criteria including: How many measures should be required? Should we maintain the policy that measures cover a specified number of NQS domains? How do we apply the quality performance category to MIPS eligible clinicians that are in specialties that may not have enough measures to meet our defined criteria? Several themes emerged from the comments. Commenters expressed concern that the general PQRS satisfactory reporting requirement to report nine measures across three NQS domains is too high and forces eligible clinicians to report measures that are not relevant to their practices. The commenters requested a more meaningful set of requirements that focused on patient care, with some expressing the opinion that NQS domain requirements are arbitrary and make reporting more difficult. Some commenters requested that we align measures across payers and consider using core measure sets. Other commenters expressed the need for flexibility and different reporting options for different types of practices.
In response to the MIPS and APMs RFI comments, and based on our desire to simplify the MIPS reporting system and make the measurement more meaningful, we proposed MIPS quality criteria that focus on measures that are important to beneficiaries and maintain some of the flexibility from PQRS, while addressing several of the issues that concerned commenters.
• To encourage meaningful measurement, we proposed to allow individual MIPS eligible clinicians and groups the flexibility to determine the most meaningful measures and reporting mechanisms for their practice.
• To simplify the reporting criteria, we are aligning the submission criteria for several of the reporting mechanisms.
• To reduce administrative burden and focus on measures that matter, we are lowering the expected number of the measures for several of the reporting mechanisms, yet are still requiring that certain types of measures be reported.
• To create alignment with other payers and reduce burden on MIPS eligible clinicians, we are incorporating measures that align with other national payers.
• To create a more comprehensive picture of the practice performance, we also proposed to use all-payer data where possible.
As beneficiary health is always our top priority, we proposed criteria to continue encouraging the reporting of certain measures such as outcome, appropriate use, patient safety, efficiency, care coordination, or patient experience measures. However, we proposed to remove the requirement for measures to span across multiple domains of the NQS. We continue to believe the NQS domains to be extremely important and we encourage MIPS eligible clinicians to continue to strive to provide care that focuses on: effective clinical care, communication,
For the 2019 MIPS adjustment year, the quality performance category will account for 50 percent of the final score, subject to the Secretary's authority to assign different scoring weights under section 1848(q)(5)(F) of the Act. Section 1848(q)(2)(E)(i)(I)(aa) of the Act states the quality performance category will account for 30 percent of the final score for MIPS. However, section 1848(q)(2)(E)(i)(I)(bb) of the Act stipulates that for the first and second years for which MIPS applies to payments, the percentage of the final score applicable for the quality performance category will be increased so that the total percentage points of the increase equals the total number of percentage points by which the percentage applied for the cost performance category is less than 30 percent. Section 1848(q)(2)(E)(i)(II)(bb) of the Act requires that, for the transition year for which MIPS applies to payments, not more than 10 percent of the of final score shall be based on performance to the cost performance category. Furthermore, section 1848(q)(2)(E)(i)(II)(bb) of the Act states that, for the second year for which MIPS applies to payments, not more than 15 percent of the final score shall be based on performance to the cost performance category. We proposed at § 414.1330 for payment years 2019 and 2020, 50 percent and 45 percent, respectively, of the MIPS final score would be based on performance on the quality performance category. For the third and future years, 30 percent of the MIPS final score would be based on performance on the quality performance category.
Section 1848(q)(5)(B)(i) of the Act requires the Secretary to treat any MIPS eligible clinician who fails to report on a required measure or activity as achieving the lowest potential score applicable to the measure or activity. Specifically, under our proposed scoring policies, a MIPS eligible clinician or group that reports on all required measures and activities could potentially obtain the highest score possible within the performance category, presuming they performed well on the measures and activities they reported. A MIPS eligible clinician or group who does not meet the reporting threshold would receive a zero score for the unreported items in the category (in accordance with section 1848(q)(5)(B)(i) of the Act). The MIPS eligible clinician or group could still obtain a relatively good score by performing very well on the remaining items, but a zero score would prevent the MIPS eligible clinician or group from obtaining the highest possible score.
The following is summary of the comments we received regarding our general strategy and the quality performance category contribution to the final score.
After consideration of the comments received regarding our general strategy and the quality performance category contribution to the final score and the additional factors described in section II.E.5.b. of this final rule with comment period, we are not finalizing this policy as proposed. Rather, as discussed in section II.E.5.e. of this final rule with comment period, the cost performance category will account for 0 percent of the final score in 2019, 10 percent of the final score in 2020, and 30 percent of the final score in 2021 and future MIPS payment years, as required by statute. In accordance with section 1848(q)(2)(E)(i)(I)(bb) of the Act, we are redistributing the final score weight from cost performance category to the quality performance category. Therefore, we are finalizing at § 414.1330(b) for MIPS payment years 2019 and 2020, 60 percent and 50 percent, respectively, of the MIPS final score will be based on performance on the quality performance category. For the third and future years, 30 percent of the MIPS final score will be based on performance on the quality performance category.
The following are the proposed criteria for the various proposed MIPS data submission mechanisms described in the proposed rule (81 FR 28181) for the quality performance category.
We proposed at § 414.1335 that individual MIPS eligible clinicians submitting data via claims and individual MIPS eligible clinicians and groups submitting via all mechanisms (excluding CMS Web Interface, and for CAHPS for MIPS survey, CMS-approved survey vendors) would be required to meet the following submission criteria. We proposed that for the applicable 12-month performance period, the MIPS eligible clinician or group would report at least six measures including one cross-cutting measure (if patient-facing) found in Table C of the Appendix in this final rule with comment period and including at least one outcome measure. If an applicable outcome measure is not available, we proposed that the MIPS eligible clinician or group would be required to report one other high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures) in lieu of an outcome measure. If fewer than six measures apply to the individual MIPS eligible clinician or group, then we proposed the MIPS eligible clinician or group would be required to report on each measure that is applicable.
MIPS eligible clinicians and groups would select their measures from either the list of all MIPS measures in Table A of the Appendix in this final rule with comment period, or a set of specialty-specific measure set in Table E of the Appendix in this final rule with comment period. We noted that some specialty-specific measure sets include measures grouped by subspecialty; in these cases, the measure set is defined at the subspecialty level.
We designed the specialty-specific measure sets to address feedback we have received in the past that the quality measure selection process can be confusing. A common complaint about PQRS was that EPs were asked to review close to 300 measures to find applicable measures for their specialty. The specialty measure sets in Table E of the Appendix in this final rule with comment period, are the same measures that are within Table A of the Appendix in this final rule with comment period, however these are sorted consistent with the American Board of Medical Specialties (ABMS) specialties. Please note that these specialty-specific measure sets are not all inclusive of every specialty or subspecialty. We requested comments on the measures proposed under each of the specialty-specific measure sets. Specifically, we solicited comments on whether or not the measures proposed for inclusion in the specialty-specific measure sets are appropriate for the designated specialty or subspecialty and whether there are additional proposed measures that should be included in a particular specialty-specific measure set.
Furthermore, in the proposed rule we noted that there were some special scenarios for those MIPS eligible clinicians who selected their measures from a specialty-specific measure set at either the specialty or subspecialty level (Table E of the Appendix in this final rule with comment period). We provided the following example in the proposed rule, where some of the specialty-specific measure sets have fewer than six measures, in these instances MIPS eligible clinicians would report on all of the available measures including an outcome measure or, if an outcome measure is unavailable, report another high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures), within the set and a cross-cutting measure if they are a patient-facing MIPS eligible clinician. To illustrate, at the subspecialty-level the electrophysiology cardiac specialist specialty-specific measure set only has three measures within the set, all of which are outcome measures. MIPS eligible clinicians and groups reporting on the electrophysiology cardiac specialist specialty-specific measure set would report on all three measures and since these MIPS eligible clinicians are patient-facing they must also report on a cross-cutting measure which is defined in Table C of the Appendix in this final rule with comment period. In other scenarios, the specialty-specific measure sets may have six or more measures, and in these instances MIPS eligible clinicians would report on at least six measures including at least one cross-cutting measure and at least one outcome measure or, if an outcome measure is unavailable, report another high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measure). Specifically, the general surgery specialty-specific measure set has eight measures within the set, including four outcome measures, three other high priority measures and one process measure. MIPS eligible clinicians and groups reporting on the general surgery specialty-specific measure set would either have the option to report on all measures within the set or could select six measures from the set and since these MIPS eligible clinicians are patient-facing one of their
As noted above, the submission criteria is provided for each specialty-specific measure set, or in the measure set defined at the subspecialty level, if applicable. Regardless of the number of measures that are contained in a specialty-specific measure set, MIPS eligible clinicians reporting on a measure set would be required to report at least one cross-cutting measure and either at least one outcome measure or, if no outcome measures are available in that specialty-specific measure set, report another high priority measure. We proposed that MIPS eligible clinicians or groups that report on a specialty-specific measure set that includes more than six measures can report on as many measures as they wish as long as they meet the minimum requirement to report at least six measures, including one cross-cutting measure and one outcome measure, or if an outcome measure is not available another high priority measure. We solicited comment on our proposal to allow reporting of specialty-specific measure sets to meet the submission criteria for the quality performance category, including whether it is appropriate to allow reporting of a measure set at the subspecialty level to meet such criteria, since reporting at the subspecialty level would require reporting on fewer measures.
Alternatively, we solicited comment on whether we should only consider reporting up to six measures at the higher overall specialty level to satisfy the submission criteria. We noted that our proposal to allow reporting of specialty-specific measure sets at the subspecialty level was intended to address the fact that very specialized clinicians who may be represented by our subspecialty categories may only have one or two applicable measures. Further, we note that we will continue to work with specialty societies and other measure developers to increase the availability of applicable measures for specialists across the board.
We proposed to define a high priority measure at § 414.1305 as an outcome, appropriate use, patient safety, efficiency, patient experience, or care coordination quality measures. These measures are identified in Table A of the Appendix in this final rule with comment period. We further note that measure types listed as an “intermediate outcome” are considered outcome measures for the purposes of scoring (see 81 FR 28247).
As an alternative to the above proposals, we also considered requiring individual MIPS eligible clinicians submitting via claims and individual MIPS eligible clinicians and groups submitting via all mechanisms (excluding the CMS Web Interface and, for CAHPS for MIPS survey, CMS-approved survey vendors) to meet the following submission criteria. For the applicable 12-month performance period, the MIPS eligible clinician or group would report at least six measures including one cross-cutting measure (if patient-facing) found in Table C of the Appendix in this final rule with comment period and one high priority measure (outcome, appropriate use, patient safety, efficiency, patient experience, and care coordination measures). If fewer than six measures apply to the individual MIPS eligible clinician or group, then the MIPS eligible clinician or group must report on each measure that is applicable. MIPS eligible clinicians and groups will have to select their measures from either the list of all MIPS Measures in Table A of the Appendix in this final rule with comment period or a set of specialty-specific measure set in Table E of the Appendix in this final rule with comment period.
As discussed in the proposed rule (81 FR 28173), MIPS eligible clinicians who are non-patient facing MIPS eligible clinicians would not be required to report any cross-cutting measures. For further details on non-patient facing MIPS eligible clinician discussions, we refer readers to section II.E.1.b. of this final rule with comment period.
In addition, in the proposed rule (81 FR 28187) we discussed our intention to develop a validation process to review and validate a MIPS eligible clinician's or group's ability to report on at least six quality measures, or a specialty-specific measure set, with a sufficient sample size, including at least one cross-cutting measure (if the MIPS eligible clinician is patient-facing) and either an outcome measure if one is available or another high priority measure. If a MIPS eligible clinician or group had the ability to report on the minimum required measures with sufficient sample size and elects to report on fewer than the minimum required measures, then, as described in the proposed scoring algorithm (81 FR 28254), the missing measures would be scored with a zero performance score.
Our proposal is a decrease from the 2016 PQRS requirement to report at least nine measures. In addition, as previously noted, we proposed to no longer require reporting across multiple NQS domains. We believed these proposals were the best approach for the quality performance category because they decrease the MIPS eligible clinician's reporting burden while focusing on more meaningful types of measures.
We also note that we believe that outcome measures are more valuable than clinical process measures and are instrumental to improving the quality of care patients receive. To keep the emphasis on such measures in the statute, we plan to increase the requirements for reporting outcome measures over the next several years through future rulemaking, as more outcome measures become available. For example, we may increase the required number of outcome measures to two or three. We also believe that appropriate use, patient experience, safety, and care coordination measures are more relevant than clinical process measures for improving care of patients. Through future rulemaking, we plan to increase the requirements for reporting on these types of measures over time.
In consideration of which MIPS measures to identify as reasonably focused on appropriate use, we have selected measures which focus on minimizing overuse of services, treatments, or the related ancillary testing that may promote overuse of services and treatments. We have also included select measures of underuse of specific treatments or services that either (1) reflected overuse of alternative treatments and services that were are not evidence-based or supported by clinical guidelines; or (2) where the intent of the measure reflected overuse of alternative treatments and services that were not evidence-based or supported by clinical guidelines. We realize there are differing opinions on what constitutes appropriate use. Therefore, we solicited comments on what specific measures of over or under use should be included as appropriate use measures.
We plan to incorporate new measures as they become available and will give the public the opportunity to comment on these provisions through future notice and comment rulemaking. Under the Improving Medicare Post-Acute Transformation (IMPACT) Act of 2014, the Office of ASPE has been conducting studies on the issue of risk adjustment for sociodemographic factors on quality measures and cost, as well as other strategies for including SDS evaluation in CMS programs. We will closely examine the ASPE studies when they are available and incorporate findings as feasible and appropriate through future rulemaking. We look forward to working with stakeholders in this process. In
The following is summary of the comments we received regarding our proposal on submission criteria for quality measures excluding CMS Web Interface and CAHPS for MIPS.
Conversely, other commenters disagreed with our proposed measure threshold of six measures, and recommended that the measure threshold be lowered. Recommendations ranged from four measures, three measures or one to two measures. These commenters indicated that a reduced threshold would allow MIPS eligible clinicians to choose a few measures that will have a high impact on care improvements. Additionally, commenters were concerned that the threshold of six may burden practices that are struggling to find relevant measures and jeopardize their ability to achieve the maximum number of points under the quality performance category. The commenters stated that fewer required measures will reduce administrative burden, better reflect the conditions and realities of medical practice, allow MIPS eligible clinicians time to focus on quality improvement, and lead to more accurate measurement and a better snapshot of quality. Some commenters requested that CMS, the Department of Health (DOH), The Joint Commission (TJC), and Det Norske Veritas (DNV) join forces to focus on meaningful improvement.
We do note that for the initial performance period under the MIPS many flexibilities have been implemented, including a modified scoring approach which ensures that MIPS eligible clinicians who prefer to only submit data on one or two measures can avoid a negative MIPS adjustment. Furthermore, our modified scoring approach incentivizes high performers who have a robust data set available. We refer readers to section II.E.6. of this final rule with comment period for more details on the scoring approach.
We are not finalizing the requirement that one of the measures must be a cross-cutting measure. Although we still believe that the concept of having a common set of measures available to clinicians that they can draw from is important we understand that not all of these measures are the most meaningful to clinicians and their scope of practice. We do strongly recommend however that where appropriate, clinicians continue to perform and submit data on these measures to CMS. Lastly, while we recognize that there are limitations in the current set of available outcome measures, we believe that a strong emphasis on outcome-based measurement is critical to improving the quality of care. Due to these limitations in the available outcome measure set, we are finalizing that MIPS eligible clinician may select another high priority measure if an outcome is not available.
Other commenters expressed concern that the ability of MIPS eligible clinicians to select their own measures could result in the reliance on low-bar measures that do not drive value-based care. The commenters recommended that CMS encourage MIPS eligible clinicians to report both an outcome and a high priority measures representative of their patient populations. Another commenter stated CMS should finalize requirements that provide more explicit standards around the type and caliber of measures that MIPS eligible clinicians and groups must report. The commenter encouraged CMS to utilize variations in weighting and scoring of measures to incentivize greater reporting on clinical and patient-reported outcomes measures. The commenter supported the inclusion of patient-reported outcomes and patient experience measures in MIPS.
Other commenters recommended re-evaluation of the quality measures required by MIPS. The commenters stated that under the proposed rule, MIPS eligible clinicians participating in MIPS would choose six quality measures to report, one of which must be an outcome measure, and another a cross-cutting measure. The commenters recognized that CMS proposed this approach to reduce administrative burden and allow clinicians the flexibility to choose appropriate measures; however, was concerned that this approach may not meaningfully advance the quality of care provided to Medicare beneficiaries. The commenters stated given the financial incentive, the commenter would expect that MIPS eligible clinicians will select those measures on which they are already high-performing and on which they believe they can be at the top of the curve. Thus, they will focus more effort on the few areas that are existing strengths, and have limited incentive to drive improvement in a broad set of areas. The commenter recommended that CMS leverage the work of the Core Quality Measure Collaborative—which brought together stakeholders from America's Health Insurance Plans (AHIP), CMS and the National Quality Forum (NQF), as well as national physician organizations, employers and consumers—and select core sets of measures for each specialty to report. The commenters also proposed bonus points for clinicians who choose to report innovative, outcome-based measures in addition to the core set.
Regardless of the number of measures that are contained in the measure set, MIPS eligible clinicians reporting on a measure set will be required to report at least one outcome measure or, if no outcome measures are available in the measure set, report another high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures) within the measure set in lieu of an outcome measure. For the commenter's specific questions, there is no penalty or harm in submitting more measures than required. Rather, this can benefit the clinician because if more measures than the six required are submitted, we would score all measures and use only those that have the highest performance, which can result in a MIPS eligible clinician receiving a higher score. Lastly, we note that since we are not finalizing the requirement of cross-cutting measures in the quality performance category, there is no difference in requirements for patient facing and non-patient facing clinicians in the quality performance category.
We do intend to provide toolkits and educational materials to MIPS eligible clinicians that will reduce the burden on determining which measures are applicable. We do not believe, however, that it is appropriate to exempt specialties from the quality performance category if they have fewer than six measures or topped out measures. Rather these specialties are still able to report on quality measures, just a lesser the number of measures. We refer the readers to section II.E.6. of this final rule with comment period for the discussion of authority under 1848(q)(5)(F) to reweight category weights when there are insufficient measures applicable and available.
After consideration of the comments regarding our proposal on submission criteria for quality measures excluding CMS Web Interface and CAHPS for MIPS, we are finalizing at § 414.1335(a)(1) that individual MIPS eligible clinicians submitting data via claims and individual MIPS eligible clinicians and groups submitting via all mechanisms (excluding CMS Web Interface, and for CAHPS for MIPS survey, CMS-approved survey vendors) are required to meet the following submission criteria. For the applicable period during the performance period as discussed in section II.E.5.b.(3) of this final rule with comment period, the MIPS eligible clinician or group will report at least six measures including at least one outcome measure. If an applicable outcome measure is not available, the MIPS eligible clinician or group will be required to report one other high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures) in lieu of an outcome measure. If fewer than six measures apply to the individual MIPS eligible clinician or group, then the MIPS eligible clinician or group will be required to report on each measure that is applicable. We define “applicable” to mean measures relevant to a particular MIPS eligible clinician's services or care rendered.
Alternatively, for the applicable performance period in 2017, the MIPS eligible clinician or group will report one specialty-specific measure set, or the measure set defined at the subspecialty level, if applicable. If the measure set contains fewer than six measures, MIPS eligible clinicians will be required to report all available measures within the set. If the measure set contains six or more measures, MIPS eligible clinicians will be required to report at least six measures within the set. Regardless of the number of measures that are contained in the measure set, MIPS eligible clinicians reporting on a measure set will be required to report at least one outcome measure or, if no outcome measures are available in the measure set, report another high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures) within the measure set in lieu of an outcome measure. MIPS eligible clinicians may choose to report measures in addition to those contained in the specialty-specific measure set will not be penalized for doing so, provided such MIPS eligible clinicians follow all requirements discussed here.
In accordance with § 414.1335(a)(1)(ii), MIPS eligible clinicians and groups will select their measures from either the list of all MIPS measures in Table A of the Appendix in this final rule with comment period, or a set of specialty-specific measure set in Table E of the Appendix in this final rule with comment period. Note that some specialty-specific measure sets include measures grouped by subspecialty; in these cases, the measure set is defined at the subspecialty level.
We also are finalizing the definition of a high priority measure at § 414.1305 means an outcome, appropriate use, patient safety, efficiency, patient experience, or care coordination quality measures. These measures are identified in Table A of the Appendix in this final rule with comment period.
We are not finalizing our proposal to require MIPS eligible clinicians and groups to report a cross-cutting measure because we believe we should provide flexibility during the transition year of the program as MIPS eligible clinicians adjust to MIPS. However, we are seeking comments on adding a requirement to our modified proposal that patient-facing MIPS eligible clinicians would be required to report at least one cross-cutting measure in addition to the high priority measure requirement for further consideration for MIPS year 2 and beyond. We are interested in feedback on how we could construct a cross-cutting measure requirement that would be most meaningful to MIPS eligible clinicians from different specialties and that would have the greatest impact on improving the health of populations.
We proposed at § 414.1335 the following criteria for the submission of data on quality measures by registered groups of 25 or more MIPS eligible clinicians who want to report via the CMS Web Interface. For the applicable 12-month performance period, we proposed that the group would be required to report on all measures included in the CMS Web Interface completely, accurately, and timely by populating data fields for the first 248 consecutively ranked and assigned Medicare beneficiaries in the order in which they appear in the group's sample for each module/measure. If the pool of eligible assigned beneficiaries is less than 248, then the group would
Lastly, from our experience with using the CMS Web Interface under prior Medicare programs we are aware groups may register for this mechanism and have zero Medicare patients assigned and sampled to them. We note that should a group have no assigned patients, then the group, or individual MIPS eligible clinicians within the group, would need to select another mechanism to submit data to MIPS. If a group does not typically see Medicare patients for which the CMS Web Interface measures are applicable, or if the group does not have adequate billing history for Medicare patients to be used for assignment and sampling of Medicare patients into the CMS Web Interface, we advise the group to participate in the MIPS via another reporting mechanism.
As discussed in the CY 2016 PFS final rule with comment period (80 FR 71144), beginning with the 2017 PQRS payment adjustment, the PQRS aligned with the VM's beneficiary attribution methodology for purposes of assigning patients for groups that registered to participate in the PQRS Group Reporting Option (GPRO) using the CMS Web Interface (formerly referred to as the GPRO Web Interface). For certain quality and cost measures, the VM uses a two-step attribution process to associate beneficiaries with TINs during the period in which performance is assessed. This process attributes a beneficiary to the TIN that bills the plurality of primary care services for that beneficiary (79 FR 67960-67964). We proposed to continue to align the 2019 CMS Web Interface beneficiary assignment methodology with the measures that used to be in the VM: The population quality measures discussed in the proposed rule (81 FR 28188) and total per capita cost for all attributed beneficiaries discussed in proposed rule (81 FR 28188). As MIPS is a different program, we proposed to modify the attribution process to update the definition of primary care services and to adapt the attribution to different identifiers used in MIPS. These changes are discussed in the proposed rule (81 FR 28188). We requested comments on these proposals.
The following is summary of the comments we received regarding our proposal on submission criteria for quality measures for groups reporting via the CMS Web Interface.
Another problematic example the commenter provided was the medication safety measure (CARE 3). The commenter stated that the score includes all medications the patient is taking, including over-the-counter and herbal medications, and therefore relies on the patient recalling and accurately reporting this information. For each medication on the list, clinicians must include the dose, route (for example, by mouth or by injection), and frequency. This measure is difficult to meet, even if medication lists are substantially complete. According to the specifications, if a multi-vitamin is listed but “by mouth” is not recorded then the encounter(s) is scored as non-performance. Finally, the commenter believed that the blood pressure measure must be updated to reflect recent national consensus about appropriate blood pressure measurements. The commenter stated that a national consensus has developed that blood pressure should vary by age and diagnosis. However, the measure requires a strict policy of controlling to less than 140/90 for hypertensive patients, regardless of age, and 120/80 for screening purposes. These levels are not consistent with current medical evidence or opinion such as those noted in the Eighth Joint National Committee.
After consideration of the comments regarding our proposal on submission criteria for quality measures for groups reporting via the CMS Web Interface, we are finalizing the policies as proposed. Specifically, we are finalizing at § 414.1335(a)(2) the following criteria for the submission of data on quality measures by registered groups of 25 or more MIPS eligible clinicians who want to report via the CMS Web Interface. For the applicable 12-month performance period, the group will be required to report on all measures included in the CMS Web Interface completely, accurately, and timely by populating data fields for the first 248 consecutively ranked and assigned Medicare beneficiaries in the order in which they appear in the group's sample for each module or measure. If the sample of eligible assigned beneficiaries is less than 248, then the group will report on 100 percent of assigned beneficiaries. A group will be required to report on at least one measure for which there is Medicare patient data. Groups reporting via the CMS Web Interface are required to report on all of the measures in the set. Any measures not reported will be considered zero performance for that measure in our scoring algorithm.
We are finalizing our proposal to continue to align the 2019 CMS Web Interface beneficiary assignment methodology with the measures that used to be in the VM: The population quality measure discussed in the proposed rule (81 FR 28188) and total per capita cost for all attributed beneficiaries discussed in the proposed rule (81 FR 28196). We are also finalizing our proposal to modify the attribution process to update the definition of primary care services and to adapt the attribution to different identifiers used in MIPS. These changes are discussed in the proposed rule (81 FR 28196).
(iii) Performance Criteria for Quality Measures for Groups Electing to Report Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS Survey
The CAHPS for MIPS survey (formerly known as the CAHPS for PQRS survey) consists of the core CAHPS Clinician & Group Survey developed by Agency for Health Care Research (AHRQ), plus additional survey questions to meet CMS's information and program needs. For more information on the CAHPS for MIPS survey, please see the explanation of the CAHPS for PQRS survey in the CY 2016 PFS final rule with comment period (80 FR 71142 through 71143). While we anticipate that the CAHPS for MIPS survey will closely align with the CAHPS for PQRS survey, we may explore the possibility of updating the CAHPS for MIPS survey under MIPS, specifically we may not finalize all proposed Summary Survey Measures (SSM).
We proposed to allow registered groups to voluntarily elect to participate in the CAHPS for MIPS survey. Specifically, we proposed at § 414.1335 the following criteria for the submission of data on the CAHPS for MIPS survey by registered groups via CMS-approved survey vendor: For the applicable 12-month performance period, the group must have the CAHPS for MIPS survey reported on its behalf by a CMS-approved survey vendor. In addition, the group will need to use another submission mechanism (that is, qualified registries, QCDRs, EHR etc.) to complete their quality data submission.
The administration of the CAHPS for MIPS survey would contain a 6-month look-back period. In previous years the CAHPS for PQRS survey was administered from November to February of the reporting year. We proposed to retain the same survey administration period for the CAHPS for MIPS survey. Groups that voluntarily elect to participate in the CAHPS for MIPS survey would bear the cost of contracting with a CMS-approved survey vendor to administer the CAHPS for MIPS survey on the group's behalf, just as groups do now for the CAHPS for PQRS survey.
Under current provisions of PQRS, the CAHPS for PQRS survey is required for groups of 100 or more eligible clinicians. Although we are not requiring groups to participate in the CAHPS for MIPS survey, we do still believe patient experience is important, and we therefore proposed a scoring incentive for those groups who report the CAHPS for MIPS survey. As described in the proposed rule (81 FR 28188), we proposed that groups electing to report the CAHPS for MIPS survey, would be required to register for the reporting of data. Because we believe assessing patients' experiences as they interact with the health care system is important, our proposed scoring methodology would give bonus points for reporting CAHPS data (or other patient experience measures). Please refer to the proposed rule (81 FR 28247), for further details. We solicited comments on whether the CAHPS for MIPS survey should be required for groups of 100 or more MIPS eligible clinicians or whether it should be voluntary.
Currently, the CAHPS for PQRS beneficiary sample is based on Medicare claims data. Therefore, only Medicare beneficiaries can be selected to participate in the CAHPS for PQRS survey. In future years of the MIPS program, we may consider expanding the potential patient experience measures to all payers, so that Medicare and non-Medicare patients can be included in the CAHPS for MIPS survey sample. We solicited comments on criteria that would ensure comparable samples and on these proposals.
The following is a summary of the comments we received regarding our proposed performance criteria for quality measures for groups electing to report the CAHPS for MIPS survey.
After consideration of the comments regarding our proposed performance criteria for quality measures for groups electing to report the CAHPS for MIPS survey we are finalizing the policies as proposed. Specifically, we are finalizing at § 414.1335(a)(3) the following criteria for the submission of data on the CAHPS for MIPS survey by registered groups via CMS-approved survey vendor: For the applicable 12-month performance period, a group that wishes to voluntarily elect to participate in the CAHPS for MIPS survey measures must use a survey vendor that is approved by CMS for a particular performance period to transmit survey measures data to CMS. The CAHPS for MIPS survey counts for one measure towards the MIPS quality performance category and, as a patient experience measure, also fulfills the requirement to report at least one high priority measure in the absence of an applicable outcome measure. In addition, groups that elect this data submission mechanism must select an additional group data submission mechanism (that is, qualified registries, QCDRs, EHR etc.) in order to meet the data submission criteria for the MIPS quality performance category. The CAHPS for MIPS survey will count as one patient experience measure, and the group will be required to submit at least five other measures through one other data submission mechanisms. A group may report any five measures within MIPS plus the CAHPS for MIPS survey to achieve the six measures threshold. We will retain the survey administration period for the CAHPS for MIPS survey November to February. Groups that voluntarily elect to participate in the CAHPS for MIPS survey will bear the cost of contracting with a CMS-approved survey vendor to administer the CAHPS for MIPS survey on the group's behalf. Groups electing to report the CAHPS for MIPS survey will be required to register for the reporting of data. Only Medicare beneficiaries can be selected to participate in the CAHPS for MIPS survey.
We want to ensure that data submitted on quality measures are complete enough to accurately assess each MIPS eligible clinician's quality performance. Section 1848(q)(5)(H) of the Act provides that analysis of the quality performance category may include quality measure data from other payers, specifically, data submitted by MIPS eligible clinicians with respect to items and services furnished to individuals who are not individuals entitled to benefits under Part A or enrolled under Part B of Medicare.
To ensure completeness for the broadest group of patients, we proposed at § 414.1340 the criteria below. MIPS eligible clinicians and groups who do not meet the proposed reporting criteria noted below would fail the quality component of MIPS.
• Individual MIPS eligible clinicians or groups submitting data on quality measures using QCDRs, qualified registries, or via EHR need to report on at least 90 percent of the MIPS eligible clinician or group's patients that meet the measure's denominator criteria, regardless of payer for the performance period. In other words, for these submission mechanisms, we would expect to receive quality data for both Medicare and non-Medicare patients.
• Individual MIPS eligible clinicians submitting data on quality measures data using Medicare Part B claims would report on at least 80 percent of the Medicare Part B patients seen during the performance period to which the measure applies.
• Groups submitting quality measures data using the CMS Web Interface or a CMS-approved survey vendor to report the CAHPS for MIPS survey would need to meet the data submission requirements on the sample of the Medicare Part B patients CMS provides.
We proposed to include all-payer data for the QCDR, qualified registry, and EHR submission mechanisms because we believe this approach provides a more complete picture of each MIPS eligible clinicians scope of practice and provides more access to data about specialties and subspecialties not currently captured in PQRS. In addition, we proposed the QCDR, qualified registry, or EHR submission must contain a minimum of one quality measure for at least one Medicare patient.
We desire all-payer data for all reporting mechanisms, yet certain reporting mechanisms are limited to Medicare Part B data. Specifically, the claims reporting mechanism relies on individual MIPS eligible clinicians attaching quality information on Medicare Part B claims; therefore only Medicare Part B patients can be reported by this mechanism. The CMS Web Interface and the CAHPS for MIPS survey currently rely on sampling protocols based on Medicare Part B billing; therefore, only Medicare Part B beneficiaries are sampled through that methodology. We welcomed comments on ways to modify the methodology to assign and sample patients for these mechanisms using data from other payers.
The data completeness criteria we proposed are an increase in the percentage of patients to be reported by each of the mechanisms when compared to PQRS. We believe the proposed thresholds are appropriate to ensure a more accurate assessment of a MIPS eligible clinician's performance on the quality measures and to avoid any selection bias that may exist under the current PQRS requirements. In addition, we would like to align all the reporting mechanisms as closely as possible with achievable data completeness criteria. We intend to continually assess the proposed data completeness criteria and will consider increasing these
We were also interested in data that would indicate these data completeness criteria are inappropriate. For example, we could envision that reporting a cross-cutting measure would not always be appropriate for every telehealth service or for certain acute situations. We would not want a MIPS eligible clinician to fail reporting the measure in appropriate circumstances; therefore, we solicited feedback data and circumstances where it would be appropriate to lower the data completeness criteria.
The following is summary of the comments we received regarding our proposed data completeness criteria.
Another commenter noted that MIPS eligible clinicians reporting outcomes should document all factors affecting outcomes, especially adversely affecting outcomes. The commenter stated that socioeconomic status, family support systems, cognitive dysfunction and mental health issues affect compliance and outcomes. Therefore, coding for some of these factors can be misleading, even if there are available options for diagnostic coding. The commenter noted that open access to all physician notes would jeopardize proper documentation of these issues. The commenter added that diagnostic coding must not inhibit documentation of issues and concerns for physicians, and that there must be proper acuity adjustment in measuring physician or team performance. The commenter suggested that all charts have certain areas of restricted protected access to allow documentation of such issues, and that this type of charting must be available to physicians who are not categorized as mental health professionals.
As a result of the comments regarding our proposal on data completeness criteria we are not finalizing our policy as proposed. Rather we are finalizing at § 414.1340 the data completeness criteria below for MIPS during the 2017 performance period.
• Individual MIPS eligible clinicians or groups submitting data on quality measures using QCDRs, qualified registries, or via EHR must report on at least 50 percent of the MIPS eligible clinician or group's patients that meet the measure's denominator criteria, regardless of payer for the performance period. In other words, for these submission mechanisms, we expect to receive quality data for both Medicare and non-Medicare patients. For the transition year, MIPS eligible clinicians whose measures fall below the data completeness threshold of 50 percent would receive 3 points for submitting the measure.
• Individual MIPS eligible clinicians submitting data on quality measures data using Medicare Part B claims, would report on at least 50 percent of the Medicare Part B patients seen during the performance period to which the measure applies. For the transition year, MIPS eligible clinicians whose measures fall below the data completeness threshold of 50 percent would receive 3 points for submitting the measure.
• Groups submitting quality measures data using the CMS Web Interface or a CMS-approved survey vendor to report the CAHPS for MIPS survey must meet the data submission requirements on the sample of the Medicare Part B patients CMS provides.
We are also finalizing to ramp up the data completeness threshold to 60 percent for MIPS for performance periods occurring in 2018 for data submitted on quality measures using QCDRs, qualified registries, via EHR, or Medicare Part B claims. We note that these thresholds for data submitted on quality measures using QCDRs, qualified registries, via EHR, or Medicare Part B claims will increase for performance periods occurring in 2019 and onward. As noted in our proposal, we believe higher thresholds are appropriate to ensure a more accurate assessment of a MIPS eligible clinician's performance on the quality measures and to avoid any selection bias. In addition, we would like to align all the reporting mechanisms as closely as possible with achievable data completeness criteria.
We are finalizing our approach of including all-payer data for the QCDR,
We are not finalizing our proposal that MIPS eligible clinicians and groups who do not meet the proposed submission criteria noted below would fail the quality component of MIPS. Instead, those MIPS eligible clinicians who fall below the data completeness thresholds would have their specific measures that fall below the data completeness threshold not scored for the transition year of MIPS. The MIPS eligible clinicians would receive 3 points for measures that fall below the data completeness threshold.
Table 5 of the rule, reflects our final Quality Data Submission Criteria for MIPS:
Section 1848(q)(2)(C)(iv) of the Act provides that the Secretary must give consideration to the circumstances of non-patient facing MIPS eligible clinicians and may, to the extent feasible and appropriate, take those circumstances into account and apply alternative measures or activities that fulfill the goals of the applicable performance category to such clinicians. In doing so, the Secretary must consult with non-patient facing MIPS eligible clinicians.
In addition, section 1848(q)(5)(F) to the Act allows the Secretary to re-weight MIPS performance categories if there are not sufficient measures and activities applicable and available to each type of MIPS eligible clinician. We assume many non-patient facing MIPS eligible clinician will not have sufficient measures and activities applicable and available to report and will not be scored on the quality performance category under MIPS. We refer readers to the proposed rule (81 FR 28247) to the discussion on how we address performance categories weighting for MIPS eligible clinicians for whom no measures exist in a given performance category.
In the MIPS and APMs RFI, we solicited feedback on how we should apply the four MIPS performance categories to non-patient facing MIPS eligible clinicians and what types of measures and/or improvement activities (new or from other payments systems) would be appropriate for these MIPS
We understand that non-patient facing MIPS eligible clinicians may have a limited number of measures on which to report. Therefore, we proposed at § 414.1335 that non-patient facing MIPS eligible clinicians would be required to meet the otherwise applicable submission criteria, but would not be required to report a cross-cutting measure.
Thus we would employ the following strategy for the quality performance criteria to accommodate non-patient facing MIPS eligible clinicians:
• Allow non-patient facing MIPS eligible clinicians to report on specialty-specific measure set (which may have fewer than the required six measures).
• Allow non-patient facing MIPS eligible clinicians to report through a QCDR that can report non-MIPS measures.
• Non-patient facing MIPS eligible clinicians would be exempt from reporting a cross-cutting measure as proposed at § 414.1340.
We requested comments on these proposals.
The following is summary of the comments we received regarding our proposals on the application of quality measures to non-patient facing MIPS eligible clinicians:
After consideration of the comments received regarding our proposals on application of the quality category to non-patient facing MIPS eligible clinicians we are not finalizing as proposed. As previously noted in this rule, we are not finalizing the criteria proposed at § 414.1335 that MIPS eligible clinicians that are considered patient facing must report a cross-cutting measure. The only distinction within the quality performance for non-patient facing MIPS eligible clinicians as proposed at § 414.1335 is that they were not required to report a cross-cutting measure. We are therefore finalizing at § 414.1335 that non-patient facing MIPS eligible clinicians would be required to meet the otherwise applicable submission criteria that apply for all MIPS eligible clinicians for the quality performance category.
Section 1848(q)(2)(C)(ii) of the Act provides that the Secretary may use measures used for payment systems other than for physicians, such as measures used for inpatient hospitals, for purposes of the quality and cost performance categories. The Secretary may not, however, use measures for hospital outpatient departments, except in the case of items and services furnished by emergency physicians, radiologists, and anesthesiologists.
In the MIPS and APMs RFI, we sought comment on how we could best use this authority. Some facility-based commenters requested a submission option that allows the MIPS eligible clinician to be scored based on the facility's measures. These commenters noted that the care they provide directly relates to and affects the facility's overall performance on quality measures and that using this score may be a more accurate reflection of the quality of care they provide than the quality measures in the PQRS or the VM program.
We will consider an option for facility-based MIPS eligible clinicians to elect to use their institution's performance rates as a proxy for the MIPS eligible clinician's quality score. We are not proposing an option for the transition year of MIPS because there are several operational considerations that must be addressed before this option can be implemented. We requested comment on the following issues: (1) whether we should attribute a facility's performance to a MIPS eligible clinician for purposes of the
The following is summary of the comments we received regarding our approaches to application of additional system measures:
One commenter believed that hospital quality reporting should substitute for MIPS quality reporting for hospital based clinicians. While another commenter specified that hospital measures should only be used for the quality performance category, not for the cost performance category. Another commenter strongly recommended CMS either allow hospital based clinicians to use hospital quality measures for MIPS reporting, or exempt hospital based clinicians from the quality performance category until there is substantial alignment of clinician and hospital measures. This commenter requested that such exemption be the same as the hospital based clinician exemption under the advancing care information performance category.
Another commenter opposed our proposed use of facility level measures for accountability at the individual level as facility performance as they believed it is not within the control of individual clinicians. Another commenter requested that facility-based MIPS eligible clinicians leverage continued expansion of specialty-specific measure sets through QCDRs and qualified registries instead of using facility-based scores. Another commenter noted that adding an additional group reporting option for facility-based MIPS eligible clinicians on top of the existing group reporting option is confusing. The commenter therefore recommended CMS remove this reporting option from the proposal. One commenter encouraged revisiting this proposal in future years.
The same commenter proposed the following options for attribution: Option 1: The facility-based MIPS eligible clinician performed a plurality of his or her services at the facility in the performance period. This proposed method for attribution generally aligned with the Value-Based Payment Modifier two-step attribution methodology for purposes of MIPS quality and cost measurement proposed in other parts of the MACRA rule, which attributes a given patient to a clinician if the clinician has performed a plurality of the primary care services for a patient in the performance period. Option 2: The facility-based MIPS eligible clinician or group would have a payment amount threshold or patient count threshold at the facility that meets the payment amount threshold or patient count threshold finalized for purposes of eligibility to participate in an Advanced APM.
Another commenter mentioned that in adopting additional system measures, CMS should ensure that attribution is appropriate and relevant to clinicians, to consider a methodology that enables proportional attribution that is as close a proxy for a group as possible, and to ensure that clinician performance is captured across settings.
One commenter recommended CMS explore the possibility of allowing some clinicians to report their skilled nursing facility (SNF) scores as their MIPS scores. Another commenter urged as much flexibility as possible in the program and believed that SNF-based measurement should always be an optional approach, particularly for those who practice in a single facility. Another commenter recommended that quality and cost performance measures under MIPS always be attributed to the SNF TIN, as incentive payment adjustments would only be applicable at the facility TIN level. Furthermore, the commenter stated that the attribution to the SNF TIN would need to be automatic for clinicians working in facility-based outpatient environments. One commenter recommends self-nomination at the TIN level because this would allow a group to attest that it is apprised of primarily hospital-based clinicians. This commenter noted that it would ensure that only the clinicians who wish to have this level of facility alignment are included in the program. It will also permit clinicians to select which hospitals are appropriate for alignment, allows for the inclusion of multiple hospitals, and would allow for the fact that many hospitalist groups practice in multiple locations. They also stated that this option would allow clinicians to align their performance on selected measures with their hospitals, which would support the drive towards team-based, coordinated care.
One commenter noted the challenges faced by clinicians and groups that provide care across multiple facilities and recommended hospital-level risk-adjusted outcome measurement that is attributable to the principal clinician or group responsible for the primary diagnosis. Another commenter stated that as an alternative to substituting facility measures under the MIPS program, facility-based clinicians ought to be given the option of being treated as participating in an Advanced APM.
One commenter requested further clarification on the proxy scoring using facility's quality reporting. This commenter requested examples of proxy scoring, and wanted to see quality performance category scoring in practice before making a recommendation. Another commenter urged CMS to allow the use of PCHQR scores as a proxy for quality performance, for clinicians at PPS-exempt cancer hospitals. A couple of commenters urged CMS to make nearly all of the measures from CMS's hospital quality reporting and pay-for-performance programs available for use in hospital-based clinician reporting options. One commenter proposed the following criteria for evaluating measures: clinicians could use quality and cost measures for patient conditions and episode groups (currently under development) for which CMS has assigned them a clearly defined and clinically meaningful relationship under the patient relationship assignment methodology (currently under development). This commenter suggested that each evidence-based quality measure would be counter-balanced with an appropriate cost measure and that measures potentially could focus on patient safety, high quality care delivery, patient-centered care, communication, care coordination, and cost efficiency.
Several commenters suggested measures to be adopted. One commenter suggested the following: PCP notification at admission, PCP
One commenter believed that clinicians who are MIPS eligible clinicians, and work primarily in either an outpatient or inpatient site—or both, as cancer care clinicians often do—should have the ability to choose the measures most relevant to them. A commenter recommended that MIPS eligible clinicians be able to align with hospitals, surgery centers, or other types of institutions to utilize patient experience survey metrics that are already collected as part of other quality reporting programs, in order to enable these metrics to be used as facility-based measures. Another commenter believed it was important for CMS to ensure that only visits, medications, tests, surgeries, and other components of maintenance for a disease that are ordered by a MIPS eligible clinician are attributed to the MIPS eligible clinician's quality and cost scores.
One commenter urged CMS to enable a transplant surgeon and other members of the transplant team to elect to use their institution's performance rates under the outcomes requirements set forth at 42 CFR 482.80(c) and 482.82(c) as a proxy for their quality performance category score. This commenter believed that a transplant surgeon or other MIPS eligible clinician or group's election to use their institutions performance data should not be automatic but the clinician's choice. Another commenter noted that a facility-based performance option would be beneficial to those clinicians involved in palliative care, and requested CMS allow for measures such as those used under the Hospice Quality Reporting Program to be considered facility-based measures under MIPS.
We will take these comments into consideration in future rulemaking.
Section 1848(q)(2)(C)(iii) of the Act provides that the Secretary may use global measures, such as global outcome measures, and population-based measures for purposes of the quality performance category.
Under the current PQRS program and Medicare EHR Incentive Program quality measures are categorized by domains which include global and population-based measures. We identified population and community health measures as one of the quality domains related to the CMS Quality Strategy and the NQS priorities for health care quality improvement discussed in the proposed rule (81 FR 28192). Population-based measures are also used in the Medicare Shared Savings Program and for groups in the VM Program. For example, in 2015, clinicians were held accountable for a component of the AHRQ population-based, Ambulatory Care Sensitive Condition measures as part of a larger set of Prevention Quality Indicators (PQIs). Two broader composite measures of acute and chronic conditions are calculated using the respective individual measure rates for VM Program calculations. These PQIs assess the quality of the health care system as a whole, and especially the quality of ambulatory care, in preventing medical complications that lead to hospital admissions.
In the CY 2015 PFS final rule with comment period (79 FR 67909), Medicare Payment Advisory Commission (MedPAC) commented that we should move quality measurement four ACOs, Medicare Advantage (MA) plans, and FFS Medicare in the direction of a small set of population-based outcome measures, such as potentially preventable inpatient hospital admissions, ED visits, and readmissions. In the June 2014 MedPAC Report to the Congress:
In creating policy for global and population-based measures for MIPS we considered a more broad-based approach to the use of “global” and “population-based” measures in the MIPS quality performance category. After considering the above we proposed to use the acute and chronic composite measures of AHRQ PQIs that meet a minimum sample size in the calculation of the quality measure domain for the MIPS total performance score; see Table B of the Appendix in this final rule with comment period. MIPS eligible clinicians would be evaluated on their performance on these measures in addition to the six required quality measures discussed previously and summarized in Table A of the Appendix in this final rule with comment period. Based on experience in the VM Program, these measures have been determined to be reliable with a minimum case size of 20. Average reliabilities for the acute and chronic measures range from 0.64 to 0.79 for groups and individual MIPS eligible clinicians. We intend to incorporate a clinical risk adjustment as soon as feasible to the PQI composites and continue to research ways to develop and use other population-based measures for the MIPS program that could be applied to greater numbers of MIPS eligible clinicians going forward. In addition to the acute and chronic composite measure, we also proposed to include the all-cause hospital readmissions (ACR) measure from the VM Program as we believe this measure also encourages care coordination. In
Furthermore, the proposed claims-based population measures would rely on the same two-step attribution methodology that is currently used in the VM Program (79 FR 67961 through 67694). The attribution focuses on the delivery of primary care services (77 FR 69320) by both primary care physicians and specialists. This attribution logic aligns with the total per capita measure and is similar to, but not exactly the same, as the assignment methodology used for the Shared Savings Program. For example, the Shared Savings Program definition of primary care services can be found at § 425.20 and excludes claims for certain Skilled Nursing Facility (SNF) services that include the POS 31 modifier). In the proposed rule (81 FR 28199), we proposed to exclude the POS 31 modifier from the definition of primary care services. As described in the proposed rule (81 FR 28199), the attribution would be modified slightly to account for the MIPS eligible clinician identifiers. We solicited comments on additional measures or measure topics for future years of MIPS and attribution methodology. We requested comments on these proposals.
The following is summary of the comments we received regarding our proposal on global and population-based measures:
A few commenters supported the inclusion of risk adjustment in measures and suggested that CMS examine ASPE's future recommendations. One commenter recommended that CMS examine ASPE's recommendations to consider other strategies as well such as stratification. Other commenters stated that the stakeholders affected by these decisions should have an opportunity to review the risk adjustment findings once issued by ASPE, and comment on how CMS proposes to incorporate the ASPE findings into its quality metrics.
Several commenters urged CMS to work with the National Quality Forum (NQF) on how best to proceed with risk adjustment of quality and cost measures for sociodemographic status. One commenter recommended CMS adopt the NQF recommendation to consider risk adjustment for measures that have a conceptual relationship between sociodemographic factors and outcomes.
We additionally note that the National Quality Forum (NQF) is currently undertaking a 2-year trial period in which new measures and measures undergoing maintenance review will be assessed to determine if risk adjusting for sociodemographic factors is appropriate. This trial entails temporarily allowing inclusion of sociodemographic factors in the risk-adjustment approach for some performance measures. At the conclusion of the trial, NQF will issue recommendations on inclusion of sociodemographic factors in risk adjustment. We intend to continue engaging in the NQF process as we consider the appropriateness of adjusting for sociodemographic factors in our MIPS measures.
We would like to explain that the all-cause hospital readmission measure from VM uses 1 year of inpatient claims to identify eligible admissions and readmissions, as well as up to 1 year prior of inpatient data to collect diagnoses for risk adjustment. The measure reports a single composite risk-standardized rate derived from the volume-weighted results of hierarchical regression models for five specialty cohorts. Each specialty cohort model uses a fixed, common set of risk-adjustment variables. It is important to note a couple features of the risk adjustment design developed for CMS by the Yale School of Medicine Center for Outcomes Research & Evaluation (CORE). First, the ACR measure involves estimating separate risk adjustment models for seven different cohorts of medical professionals (general medicine, surgery/gynecology, cardiorespiratory, cardiovascular, neurology, oncology, and psychiatry because conditions typically cared for by the same team of clinicians are likely to reflect similar levels of readmission risk. The risk-adjusted readmission rates for each cohort that are then combined into a single adjusted rate. Second, for each cohort, the risk adjustment models control for age, principal diagnoses, and a broad range of comorbidities (identified from the patient's clinical history over the year preceding the index admission, not just at the time of the hospitalization). Please note that the measure has been included for the last several years in the Annual Quality Resource and Use Reports so clinician groups and clinicians can find out how they perform on the measure and use the data in the reports to improve their performance. We will not apply the readmission measure to solo practices or small groups (groups of 15 or less). We will apply the readmission measure to groups of more than 15 who meet the case volume of 200 cases. In addition, we continually reassess reliability and will monitor MIPS eligible clinicians' performance under the MIPS for unintended consequences.
It is important to note that for the VM Program, an index episode for the readmission measure is triggered when a beneficiary who has been attributed to a TIN is hospitalized with an eligible hospital admission for the measure. Note that the index admission is not directly attributed to a TIN as in the case of an episode for the Medicare Spending per Beneficiary measure; rather, index admissions are tied to the beneficiaries attributed to the TIN per the two-step methodology. Regarding evidence for whether the measure incentivizes reductions in readmissions, we refer readers to The New England Journal of Medicine article available at
We can understand why commenters see these measures as less transparent and actionable compared to the PQRS process measures. However, this is largely driven by risk adjustment and shrinkage (in the case of the ACR measure), both of which are attempts to protect clinicians from “unfair” outcomes, albeit at the cost of decreased transparency. In the context of the QRURs, we have provided supplementary tables to the QRUR containing patient level information on admissions, including reason for admission (principal diagnosis) and whether it was followed by an unplanned readmission, to support both more transparency as well as actionability. We intend to work with MIPS eligible clinicians and other stakeholders to continue improving available measures and reporting methods for MIPS.
We continually reassess measures and this is why we have worked with measure owner and stakeholders to improve the risk adjustment methodology for these measures. In addition, we have used these measures under the VM Program and have provided feedback to groups and individual clinicians for the last several years. Further, we apply case minimums to ensure measures are reliable for groups and individual clinicians. The measures are outcome focused and are calculated on behalf of the clinician using Medicare claims and other administrative data. In addition, they are low burden with the goal for groups and individual clinicians to invest in care redesign activities to improve outcomes for patients where good ambulatory coordination reduces avoidable admissions.
In addition, we have examined the global and population-based measures closely and have decided to not finalize two of these measures as part of the quality performance category score. Specifically, we are not finalizing use of the acute and chronic composite measures of AHRQ PQIs. We agree with commenters that additional enhancements need to be made to these measures for inclusion of risk adjustment. We will, however, calculate these measures for all MIPS eligible clinicians and provide feedback for informational purposes as part of the MIPS feedback.
After consideration of the comments regarding our proposal on global and population-based measures we are not finalizing all of these measures as part of the quality score. Specifically, we are not finalizing our proposal to use the acute and chronic composite measures of AHRQ PQIs. We agree with commenters that additional enhancements, including the addition of risk adjustment, needed to be made to these measures prior to inclusion in MIPS. We will, however, calculate these measures for all MIPS eligible clinicians and provide feedback for informational purposes as part of the MIPS feedback.
Lastly, we are finalizing the ACR measure from the VM Program as part of the quality measure domain for the MIPS total performance score. We are finalizing this measure with the following modifications as proposed. We will not apply the ACR measure to solo practices or small groups (groups of 15 or less). We will apply the ACR measure to groups of 16 or more who meet the case volume of 200 cases. A group would be scored on the ACR measure even if it did not submit any quality measures, if it submitted in other performance categories. Otherwise, then the group would not be scored on the readmission measure. In our transition year policies, the readmission measure alone would not produce a neutral to positive MIPS payment adjustment since in order to achieve a neutral to positive MIPS payment adjustment, a MIPS eligible clinician or group must submit information to one of the three performance categories as discussed in section II.E.7. of the final rule with comment period. In addition, the ACR measure in the MIPS transition year CY 2017 will be based on the performance period (January 1, 2017, through December 31, 2017). However, for MIPS eligible clinicians who do not meet the minimum case requirements the ACR measure is not applicable.
Under section 1848(q)(2)(D)(i) of the Act, the Secretary, through notice and comment rulemaking, must establish an annual list of quality measures from which MIPS eligible clinicians may choose for purposes of assessment for a performance period. The annual list of quality measures must be published in the
Under section 1848(q)(2)(D)(ii) of the Act, the Secretary must solicit a “Call for Quality Measures” each year. Specifically, the Secretary must request that eligible clinician organizations and other relevant stakeholders identify and submit quality measures to be considered for selection in the annual list of quality measures, as well as updates to the measures. Although we will accept quality measures submissions at any time, only measures submitted before June 1 of each year will be considered for inclusion in the annual list of quality measures for the performance period beginning 2 years after the measure is submitted. For example, a measure submitted prior to June 1, 2016 would be considered for the 2018 performance period. Of those quality measures submitted before June 1, we will determine which quality measures will move forward as potential measures for use in MIPS. Prior to finalizing new measures for inclusion in the MIPS program, those measures that we determine will move forward must also go through notice-and-comment rulemaking and the new proposed measures must be submitted to a peer review journal. Finally, for quality measures that have undergone substantive changes, we propose to identify measures including but not limited to measures that have had measure specification, measure title, and domain changes. Through NQF's or the measure steward's measure maintenance process, NQF-endorsed measures are sometimes updated to incorporate changes that we believe do not substantively change the intent of the measure. Examples of such changes may include updated diagnosis or procedure codes or changes to exclusions to the patient population or definitions. While we address such changes on a case-by case basis, we generally believe these types of maintenance changes are distinct from substantive changes to measures that result in what are considered new or different measures.
In the transition year of MIPS, we proposed to maintain a majority of previously implemented measures in PQRS (80 FR 70885-71386) for inclusion in the annual list of quality measures. These measures could be found in Table A of the Appendix of the proposed rule: Proposed Individual Quality Measures Available for MIPS Reporting in 2017 (81 FR 28399 through 28446). Also included in the Appendix in Table B of the proposed rule (81 FR 28447) was a list of proposed quality measures that do not require data submission, some of which were previously implemented in the VM (80 FR 71273-71300), that we proposed to include in the annual list of MIPS quality measures. These measures can be calculated from administrative claims data and do not require data submission. We also proposed measures that were not previously finalized for implementation in the PQRS program. These measures and their draft specifications are listed in Table D of the Appendix in the proposed rule (81 FR 28450 through 28460). The proposed specialty-specific measure sets are listed in Table E of the Appendix in the proposed rule (81 FR 28460 through 28522). As we continue to develop measures and specialty-specific measure sets, we recognize that there are many MIPS eligible clinicians who see both Medicaid and Medicare patients and seek to align our measures to utilize Medicaid measures in the MIPS quality performance category. We believe that aligning Medicaid and Medicare measures is in the interest of all clinicians and will help drive quality improvement for our beneficiaries. For future years, we solicited comment about the addition of a “Medicaid measure set” based on the Medicaid Adult Core Set (
The following is a summary of the comments we received on our proposals regarding the Annual List of Quality Measures Available for MIPS Assessment.
Based on this feedback, ONC has added a requirement to the 2015 Edition “CQM—record and export” and “CQM—import and calculate” criteria that the export and import functions must be executable by a user at any time the user chooses and without subsequent developer assistance to operate. This is an example of one way ONC is incentivizing more automated quality measurement through regulatory requirements. In addition, CMS and
The CMS Equity Plan is based on a core set of quality improvement priorities that target the individual, interpersonal, organizational, community, and policy levels of the United States health system in order to achieve equity in Medicare quality. It includes six priorities that were developed with significant input and feedback from national and regional stakeholders and reflect our guiding framework of understanding and awareness, solutions, and actions. They provide an integrated approach to build health equity into existing and new efforts by CMS and stakeholders.
Priority 1 of the CMS Equity Plan focuses on expanding the collection, reporting, and analysis of standardized demographic and language data across health care systems. Though research has identified evidence-based guidelines and practices for improving the collection of data on race, ethnicity, language, and disability status in health care settings, these guidelines are often not readily available to health care providers and staff. Preliminary research has been conducted to determine best practices for collecting sexual orientation and gender identity information in some populations, but currently there are no evidence-based guidelines to standardize this collection.
We will facilitate quality improvement efforts by disseminating best practices for the collection, reporting, and analysis of standardized data on race, ethnicity, language, sexual orientation, gender identity, and disability status so that stakeholders are able to identify and address the specific needs of their target audience(s) and monitor health disparities.
After consideration of the comments, correcting, and revising specific information, we are finalizing at § 414.1330(a)(1) that for purposes of assessing performance of MIPS eligible clinicians on the quality performance category, CMS will use quality measures included in the MIPS final list of quality measures. Specifically, we are finalizing the Final Individual Quality Measures Available for MIPS Reporting in 2017 in Table A of the Appendix in this final rule with comment period. Included in Table B of the Appendix in this final rule with comment period is a final list of quality measures that do not require data submission. Newly proposed measures that we are finalizing are listed in Table D of the Appendix in this final rule with comment period. The final specialty-specific measure sets are listed in Table E of the Appendix in this final rule with comment period. Measures that we are finalizing for removal can be found in Table F of the Appendix and measures that will have substantive changes for the 2017 performance period can be found in Table G of the Appendix in this final rule with comment period.
Each year, we have historically solicited a “Call for Quality Measures” from the public for possible quality measures for consideration for the PQRS. Under MIPS, we proposed to continue the annual “Call for Quality Measures” as a way to engage eligible clinician organizations and other relevant stakeholders in the identification and submission of quality measures for consideration. Under section 1848(q)(2)(D)(ii) of the Act, eligible clinician organizations are professional organizations as defined by nationally recognized specialty boards of certification or equivalent certification boards. However, we do not believe there needs to be any special restrictions on the type or make-up of the organizations carrying out the process of development of quality measures. Any such restriction would limit the development of quality measures and the scope and utility of the quality measures that may be considered for endorsement. Submission of potential quality measures regardless of whether they were previously published in a proposed rule or endorsed by an entity with a contract under section 1890(a) of the Act, which is currently the National Quality Forum, is encouraged.
As previously noted, we encourage the submission of potential quality measures regardless of whether such measures were previously published in a proposed rule or endorsed by an entity with a contract under section 1890(a) of the Act. However, consistent with the expectations established under PQRS, we proposed to request that stakeholders apply the following considerations when submitting quality measures for possible inclusion in MIPS:
• Measures that are not duplicative of an existing or proposed measure.
• Measures that are beyond the measure concept phase of development and have started testing, at a minimum.
• Measures that include a data submission method beyond claims-based data submission.
• Measures that are outcome-based rather than clinical process measures.
• Measures that address patient safety and adverse events.
• Measures that identify appropriate use of diagnosis and therapeutics.
• Measures that address the domain for care coordination.
• Measures that address the domain for patient and caregiver experience.
• Measures that address efficiency, cost and utilization of healthcare resources.
• Measures that address a performance gap or measurement gap.
We requested comment on these proposals.
The following is summary of the comments we received regarding our proposal for the Call for Quality Measures.
After consideration of the comments we are finalizing our proposal to continue the annual “Call for Quality Measures” under MIPS. Specifically, eligible clinician organizations and other relevant stakeholders may submit potential quality measures regardless of whether such measures were previously published in a proposed rule or endorsed by an entity with a contract under section 1890(a) of the Act. We do encourage measure developers and stakeholders to submit measures for NQF-endorsement as this provides a scientifically rigorous review of measures by a multi-stakeholder group of experts. Furthermore, we are finalizing that stakeholders shall apply the following considerations when submitting quality measures for possible inclusion in MIPS:
• Measures that are not duplicative of an existing or proposed measure.
• Measures that are beyond the measure concept phase of development and have started testing, at a minimum.
• Measures that include a data submission method beyond claims-based data submission.
• Measures that are outcome-based rather than clinical process measures.
• Measures that address patient safety and adverse events.
• Measures that identify appropriate use of diagnosis and therapeutics.
• Measures that address the domain for care coordination.
• Measures that address the domain for patient and caregiver experience.
• Measures that address efficiency, cost and utilization of healthcare resources.
• Measures that address a performance gap.
Section 1848(q)(2)(D)(iii) of the Act provides that, in selecting quality measures for inclusion in the annual final list of quality measures, the Secretary must provide that, to the extent practicable, all quality domains (as defined in section 1848(s)(1)(B) of the Act) are addressed by such measures and must ensure that the measures are selected consistent with the process for selection of measures under section 1848(k), (m), and (p)(2) of the Act.
Section 1848(s)(1)(B) of the Act defines “quality domains” as at least the following domains: clinical care, safety, care coordination, patient and caregiver experience, and population health and prevention. We believe the five domains applicable to the quality measures under MIPS are included in the NQS's six priorities as follows:
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Section 1848(q)(2)(D)(viii) of the Act provides that the pre-rulemaking process under section 1890A of the Act is not required to apply to the selection of MIPS quality measures. Although not required to go through the pre-rulemaking process, we have found the NQF convened Measure Application Partnership's (MAP) input valuable. We proposed that we may consider the MAP's recommendations as part of the comprehensive assessment of each measure considered for inclusion under MIPS. Elements we proposed to consider in addition to those listed in the “Call for Quality Measures” section of this final rule with comment period include a measure's fit within MIPS, if a measure fills clinical gaps, changes or updates to performance guidelines, and other program needs. Further, we will continue to explore how global and population-based measures can be expanded and plan to add additional population-based measures through future rulemaking. We requested comment on these proposals.
The following is summary of the comments we received regarding our proposal on requirements for selecting quality measures.
After consideration of the comments, we are finalizing the requirements for the selection of the Annual MIPS Quality Measures. Specifically, we will categorize measures into the six NQS domains and we intend to place future MIPS quality measures within the NQF convened Measure Application Partnership's (MAP), as appropriate. We intend to consider the MAP's recommendations as part of the comprehensive assessment of each measure considered for inclusion under MIPS.
Section 1848(q)(2)(D)(iv) of the Act, requires the Secretary to submit new measures for publication in applicable specialty-appropriate, peer-reviewed journals before including such measures in the final annual list of quality measures. The submission must include the method for developing and selecting such measures, including clinical and other data supporting such measures. We believe this opportunity for peer review helps ensure that new measures published in the final rule with comment period are meaningful and comprehensive. We proposed to use the Call for Quality Measures process as an opportunity to gather the information necessary to draft the journal articles for submission from measure developers, measure owners and measure stewards since we do not always develop measures for the quality programs. Information from measure developers, measure owners and measure stewards will include but is not limited to: background, clinical evidence and data that supports the intent of the measure; recommendation for the measure that may come from a study or the United States Preventive Services Task Force (USPSTF) recommendations; and how this measure would align with the CMS Quality Strategy. The Call for Quality Measures is a yearlong process; however, to be aligned with the regulatory timelines, establishing the proposed measure set for the year generally begins in April and concludes in July. We will submit new measures for publication in applicable specialty-appropriate, peer-reviewed journals before including such measures in the final annual list of quality measures. We requested comments on this proposal. Additionally, we solicited comment on mechanisms that could be used, such as the CMS Web site, to notify the public that the requirement to submit new measures for publication in applicable specialty-appropriate, peer-reviewed journals is met. Additionally, we solicited comment on the type of information that should be included in such notification.
The following is summary of the comments we received regarding the submission of MIPS quality measures to a peer reviewed journal.
After consideration of the comments, we are finalizing our proposal to use the Call for Quality Measures process as a forum to gather the information necessary to draft the journal articles for submission from measure developers, measure owners and measure stewards since we do not always develop measures for the quality programs. Information from measure developers, measure owners and measure stewards shall include but is not limited to: Background, clinical evidence and data that supports the intent of the measure; recommendation for the measure that may come from a study or the United States Preventive Services Task Force (USPSTF) recommendations; and how this measure would align with the CMS Quality Strategy. The submission of this information will not preclude us from conducting our own research using Medicare claims data, Medicare survey results, and other data sources that we possess. We will submit new measures for publication in applicable specialty-appropriate, peer-reviewed journals before including such measures in the final annual list of quality measures.
Under section 1848(q)(2)(D)(v) of the Act, the final annual list of quality measures must include, as applicable, measures from under section 1848(k), (m), and (p)(2) of the Act, including quality measures among: (1) Measures endorsed by a consensus-based entity; (2) measures developed under section 1848(s) of the Act; and (3) measures submitted in response to the “Call for Quality Measures” required under section 1848(q)(2)(D)(ii) of the Act. Any measure selected for inclusion that is not endorsed by a consensus-based entity must have an evidence-based focus. Further, under section 1848(q)(2)(D)(ix), the process under section 1890A of the Act is considered optional.
Section 1848(s)(1) of the Act, as added by section 102 of the MACRA, also requires the Secretary of Health and Human Services to develop a draft plan for the development of quality measures by January 1, 2016. We solicited comments from the public on the “Draft CMS Measure Development Plan” through March 1, 2016. The final CMS Measure Development Plan was finalized and posted on the CMS Web site on May 2, 2016, available at
Section 1848(q)(2)(D)(vi) of the Act provides that quality measures used by a QCDR under section 1848(m)(3)(E) of the Act are not required to be established through notice-and-comment rulemaking or published in the
Quality measures that are owned or developed by the QCDR entity and proposed by the QCDR for inclusion in MIPS but are not a part of the MIPS quality measure set are considered non-MIPS measures. If a QCDR wants to use a non-MIPS measure for inclusion in the MIPS program for reporting, we propose that these measures go through a rigorous CMS approval process during the QCDR self-nomination period. Specific details on third party intermediaries' requirements can be found in section II.E.9 of the proposed rule. The measure specifications will be reviewed and each measure will be analyzed for its scientific rigor, technical feasibility, duplication to current MIPS measures, clinical performance gaps, as evidenced by background, and literature review, and relevance to specialty practice quality improvement. Once the measures are analyzed, the QCDR will be notified of which measures are approved for implementation. Each non-MIPS measure will be assigned a unique ID that can only be used by the QCDR that proposed it. Although non-MIPS measures are not required to be NQF-endorsed, we encourage the use of NQF-endorsed measures and measures that have been in use prior to implementation in MIPS. Lastly, we note that MIPS eligible clinicians reporting via QCDR have the option of reporting MIPS measures included in Table A in the Appendix in this final rule with comment period to the extent that such measures are appropriate for the specific QCDR and have been approved by CMS. We requested comment on these proposals.
The following is a summary of the comments we received regarding our proposals on QCDR measures.
After consideration of the comments, we are finalizing at § 414.1330(a)(2) our proposal that for purposes of assessing performance of MIPS eligible clinicians on the quality performance category, CMS will use quality measures used by QCDRs. In the circumstances where a QCDR wants to use a non-MIPS measure for inclusion in the MIPS program for reporting, those measures will go through a CMS approval process during the QCDR self-nomination period. We also are finalizing our proposal to post the quality measures for use by qualified clinical data registries in the spring of 2017 for the initial performance period and no later than January 1 for future performance periods.
Section 1848(q)(2)(D)(vii)(II) of the Act provides that any quality measure specified by the Secretary under section 1848(k) or (m) of the Act and any measure of quality of care established under section 1848(p)(2) of the Act for a performance or reporting period beginning before the first MIPS performance period (herein referred to collectively as “existing quality measures”) must be included in the annual list of MIPS quality measures unless removed by the Secretary. As discussed in section II.E.4 of the proposed rule, we proposed that the performance period for the 2019 MIPS adjustment would be CY 2017, that is, January 1, 2017 through December 31, 2017. Therefore, existing quality measures would consist of those that have been specified or established by the Secretary as part of the PQRS measure set or VM measure set for a performance or reporting period beginning before CY 2017.
Section 1848(q)(2)(D)(vii)(I) of the Act provides that existing quality measures are not required to be established through notice-and-comment rulemaking or published in the
The following is a summary of the comments we received regarding our proposal on the Exception for Existing Quality Measures.
After consideration of comments received from stakeholders on our proposals for exceptions to existing quality measures, we are finalizing our policies as proposed. While CMS has modified its performance period proposal as discussed in section II.E.4 of this final rule with comment period, this policy would not be affected since the minimum 90-day performance period would not begin any earlier that January 1, 2017.
Section 1890A of the Act, as added by section 3014(b) of the Affordable Care Act, requires that the Secretary establish a pre-rulemaking process under which certain steps occur for the selection of certain categories of quality and efficiency measures, one of which is that the entity with a contract with the Secretary under section 1890(a) of the Act (that is, the NQF) convenes multi-stakeholder groups to provide input to the Secretary on the selection of such measures. These categories are described in section 1890(b)(7)(B) of the Act and include the quality measures selected for the PQRS. In accordance with section 1890A(a)(1) of the Act, the NQF convened multi-stakeholder groups by creating the MAP. Section 1890A(a)(2) of the Act requires that the Secretary make publicly available by December 1 of each year a list of the quality and efficiency measures that the Secretary is considering under Medicare. The NQF must provide the Secretary with the MAP's input on the selection of measures by February 1 of each year. The lists of measures under consideration for selection are available at
Section 1848(q)(2)(D)(viii) of the Act provides that relevant eligible clinician organizations and other relevant stakeholders, including state and national medical societies, must be consulted in carrying out the annual list of quality measures available for MIPS assessment. Section 1848(q)(2)(D)(ii)(II) of the Act defines an eligible clinician organization as a professional organization as defined by nationally recognized specialty boards of certification or equivalent certification boards. Section 1848(q)(2)(D)(viii) of the Act further provides that the pre-rulemaking process under section 1890A of the Act is not required to apply to the selection of MIPS quality measures.
Although MIPS quality measures are not required to go through the pre-rulemaking process under section 1890A of the Act, we have found the
The following is a summary of the comments we received regarding consultation with relevant eligible clinician organizations and other relevant stakeholders.
Under PQRS we realized the value in requiring EPs to report a cross-cutting measure and have proposed to continue the use of cross-cutting measures under MIPS. The cross-cutting measures help focus our efforts on population health improvement and they also allow for meaningful comparisons between MIPS eligible clinicians. Under MIPS, we proposed fewer cross-cutting measures than those available under PQRS for 2016 reporting; however, we believe the list contains measures for which all patient-facing MIPS eligible clinicians should be able to report, as the measures proposed include commonplace health improvement activities such as checking blood pressure and medication management. We proposed to eliminate some measures for which the reporting MIPS eligible clinician may not actually be providing the care, but are just reporting another MIPS eligible clinician's performance result. An example of this would be a MIPS eligible clinician who never manages a diabetic patient's glucose, yet previously could have reported a measure about hemoglobin A1c based on an encounter. This type of reporting will likely not help improve or confirm the quality of care the MIPS eligible clinician provides to his or her patients. Although there are fewer proposed cross-cutting measures under MIPS, in previous years some measures were too specialized and could not be reported on by all MIPS eligible clinicians. The proposed cross-cutting measures under MIPS are more broadly applicable and can be reported on by most specialties. Non-patient facing MIPS eligible clinicians do not have a cross-cutting measure requirement. The cross-cutting measures that were available under PQRS for 2016 reporting that are not being proposed as cross-cutting measures for 2017 reporting are:
• PQRS #001 (Diabetes: Hemoglobin A1c Poor Control).
• PQRS #046 (Medication Reconciliation Post Discharge).
• PQRS #110 (Preventive Care and Screening: Influenza Immunization).
• PQRS #111 (Pneumonia Vaccination Status for Older Adults).
• PQRS #112 (Breast Cancer Screening).
• PQRS #131 (Pain Assessment and Follow-Up).
• PQRS #134 (Preventive Care and Screening: Screening for Clinical Depression and Follow-Up Plan).
• PQRS #154 (Falls: Risk Assessment).
• PQRS #155 (Falls: Plan of Care).
• PQRS #182 (Functional Outcome Assessment).
• PQRS #240 (Childhood Immunization Status).
• PQRS #318 (Falls: Screening for Fall Risk).
• PQRS #400 (One-Time Screening for Hepatitis C Virus (HCV) for Patients at Risk).
While we proposed to remove the above listed measures from the cross-cutting measure set, these measures were proposed to be available as individual quality measures available for MIPS reporting, some of which have proposed substantive changes.
The following is a summary of the comments we received regarding our proposal on cross-cutting measures for 2017 and beyond.
As a result of the comments, and based on our other finalized policies, we are not finalizing the set of cross-cutting measures as proposed to reduce the complexity of the program. Rather we are incorporating these measures within the MIPS individual (Table A) and specialty measure sets (Table E) within the appendix of this final rule with comment period. We continue to value the reporting of cross-cutting measures to incentivize improvements in population health and in order to be better able to compare large numbers of physicians on core quality measures that are important to patients and the health of populations. We understand that many clinicians believe that cross-cutting measures may not apply to them. We are seeking additional comments in this final rule with comment period from the public for future notice-and-comment rulemaking on approaches to implementation of cross-cutting measures in future years of the MIPS program that could achieve these program goals and be meaningful to MIPS eligible clinicians and the patients they serve.
We received a number of comments for this section that are not related to specific measure proposals as well as comments spanning multiple measure proposals that contained common themes. We have summarized those comments below.
We have considered the comments received and will take them into consideration in future notice-and-comment rulemaking.
Measuring cost is an integral part of measuring value. We envision the measures in the MIPS cost performance category would provide MIPS eligible clinicians with the information they need to provide appropriate care to their patients and enhance health outcomes. In implementing the cost performance category, we proposed to start with existing condition and episode-based measures, and the total per capita costs for all attributed beneficiaries measure (total per capita cost measure). We also proposed that all cost measures would be adjusted for geographic payment rate adjustments and beneficiary risk factors. In addition, a specialty adjustment would be applied to the total per capita cost measure. We proposed that all of the measures attributed to a MIPS eligible clinician or group would be weighted equally within the cost performance category, and there would be no minimum number of measures required to receive a score under the cost performance category. Lastly, we indicated that we plan to draw on standards for measure reliability, patient attribution, risk adjustment, and payment standardization from the VM as well as the Physician Feedback Program, as we believe many of the same measurement principles for cost measurement in the VM are applicable for measurement in the cost performance category in MIPS (81 FR 28196).
We proposed that all measures used under the cost performance category would be derived from Medicare administrative claims data and as a result, participation would not require use of a data submission mechanism.
In response to public comments, as detailed in section II.E.5.e.(2) of this final rule with comment period, we are lowering the weight of the cost performance category in the MIPS final score from 10 percent in the proposed rule to 0 percent for the transition year (MIPS payment year 2019). We are finalizing a weight of 10 percent for MIPS payment year 2020. For MIPS payment year 2021 and beyond, the cost performance category will have a weight of 30 percent of the final score as required by section 1848(q)(5)(E)(i) of the Act. Reducing the weight of the cost performance category provides MIPS eligible clinicians and groups the opportunity to better understand the cost measures in MIPS without an effect on their payments, especially the impact of adjustments to the attribution methodologies and their performance based on the MIPS decile scoring system. We are also limiting the cost measures finalized for the CY 2017 performance period to those that have been included in the VM or the 2014 sQRUR and that are reliable for both individual and group reporting. We plan to continue developing care episode groups, patient condition groups, and patient relationship categories (and codes for such groups and categories). We plan to incorporate new measures as they become available and will give the public the opportunity to comment on these provisions through future notice and comment rulemaking.
The following is a summary of the comments we received on the general provisions of cost measurement within the MIPS program.
Section 1848(q)(2)(A)(ii) of the Act establishes cost as a performance category under the MIPS. Section 1848(q)(2)(B)(ii) of the Act describes the measures of the cost performance category as the measurement of resource use for a MIPS performance period under section 1848(p)(3) of the Act, using the methodology under section 1848(r) of the Act as appropriate, and, as feasible and applicable, accounting for the cost of drugs under Part D.
As discussed in section II.E.5.e.(1)(c) of the proposed rule, we previously established in rulemaking the VM, as required by section 1848(p) of the Act, that provides for differential payment to a physician or a group of physicians (and EPs as the Secretary determines appropriate) under the PFS based on the quality of care furnished compared to cost. For the evaluation of costs of care, section 1848(p)(3) of the Act refers to appropriate measures of costs established by the Secretary that eliminate the effect of geographic adjustments in payment rates and take into account risk factors (such as socioeconomic and demographic characteristics, ethnicity, and health status of individuals, such as to recognize that less healthy individuals
Section 1848(r) of the Act specifies a series of steps and activities for the Secretary to undertake to involve the physician, practitioner, and other stakeholder communities in enhancing the infrastructure for cost measurement, including for purposes of MIPS and APMs. Section 1848(r)(2) of the Act requires the development of care episode and patient condition groups, and classification codes for such groups. That section provides for care episode and patient condition groups to account for a target of an estimated one-half of expenditures under Medicare Parts A and B (with this target increasing over time as appropriate). We are required to take into account several factors when establishing these groups. For care episode groups, we must consider the patient's clinical issues at the time items and services are furnished during an episode of care, such as clinical conditions or diagnoses, whether or not inpatient hospitalization occurs, the principal procedures or services furnished, and other factors determined appropriate by the Secretary. For patient condition groups, we must consider the patient's clinical history at the time of a medical visit, such as the patient's combination of chronic conditions, current health status, and recent significant history (such as hospitalization and major surgery during a previous period), and other factors determined appropriate. We are required to post on the CMS Web site a draft list of care episode and patient condition groups and codes for solicitation of input from stakeholders, and subsequently, post on the CMS Web site an operational list of such groups and codes. As required by section 1848(r)(2)(H) of the Act, no later than November 1 of each year (beginning with 2018), the Secretary shall, through rulemaking, revise the operational list as the Secretary determines may be appropriate.
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. These categories shall include different relationships of the clinician to the patient and reflect various types of responsibility for and frequency of furnishing care. We are required to post on the CMS Web site a draft list of patient relationship categories and codes for solicitation of input from stakeholders, and subsequently, post on the CMS Web site an operational list of such categories and codes. As required by section 1848(r)(3)(F) of the Act, not later than November 1 of each year (beginning with 2018), the Secretary shall, through rulemaking, revise the operational list as the Secretary determines may be appropriate.
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).
Under section 1848(r)(5) of the Act, to evaluate the resources used to treat patients, the Secretary shall, as determined appropriate, use the codes reported on claims under section 1848(r)(4) of the Act to attribute patients to one or more physicians and applicable practitioners and as a basis to compare similar patients, and conduct an analysis of resource use. In measuring such resource use, the Secretary shall use per patient total allowed charges for all services under Medicare Parts A and B (and, if the Secretary determines appropriate, Medicare Part D) and may use other measures of allowed charges and measures of utilization of items and services. The Secretary shall seek comments through one or more mechanisms (other than notice and comment rulemaking) from stakeholders regarding the resource use methodology established under section 1848(r)(5) of the Act.
On October 15, 2015, as required by section 1848(r)(2)(B) of the Act, we posted on the CMS Web site for public comment a list of the episode groups developed under section 1848(n)(9)(A) of the Act with a summary of the background and context to solicit stakeholder input as required by section 1848(r)(2)(C) of the Act. That posting is available at
Currently, the VM established under section 1848(p) of the Act utilizes six cost measures (see 42 CFR 414.1235): (1) A total per capita costs for all attributed beneficiaries measure (which we will refer to as the total per capita cost measure); (2) a total per capita costs for all attributed beneficiaries with chronic obstructive pulmonary disease (COPD) measure; (3) a total per capita costs for all attributed beneficiaries with congestive heart failure (CHF) measure; (4) a total per capita costs for all attributed beneficiaries with coronary artery disease (CAD) measure; (5) a total per capita costs for all attributed beneficiaries with diabetes mellitus (DM) measure; and (6) an MSPB measure.
Total per capita costs (measures 1-5) and the MSPB measure include payments under both Medicare Part A and Part B, but do not include Medicare payments under Part D for drug expenses. Cost measures for the VM are attributed at the physician group and solo practice level using the Medicare-enrolled billing TIN. They are risk adjusted and payment standardized, and the expected cost is adjusted for the TIN's specialty composition. We refer readers to our discussions of these total per capita cost measures (76 FR 73433 through 73434, 77 FR 69315 through 69316), MSPB measure (78 FR 74774 through 74780, 80 FR 71295 through 71296), payment standardization methodology (77 FR 69316 through 69317
The total per capita cost measures use a two-step attribution methodology that is similar to, but not exactly the same, as the assignment methodology used for the Shared Savings Program. The attribution focuses on the delivery of primary care services (77 FR 69320) by both primary care clinicians and specialists. The MSPB measure has a different attribution methodology. It is attributed to the TIN that provides the
These total per capita cost measures include payments for a calendar year and have been reported to TINs for several years through the Quality and Resource Use Reports (QRURs), which are issued as part of the Physician Feedback Program under section 1848(n) of the Act. The total per capita cost measures have been used in the calculation of the VM payment adjustments beginning with the 2015 payment adjustment period and the MSPB measure has been used in the calculation of the VM payment adjustments beginning with the 2016 payment adjustment period. More information about the current attribution methodology for these measures is available in the “Fact Sheet for Attribution in the Value-Based Payment Modifier Program” document available at
In the MIPS and APMs RFI (80 FR 59102 through 59113), we solicited feedback on the cost performance category. A summary of those comments is located in the proposed rule (81 FR 28198).
As required by section 1848(q)(5)(E)(i)(II)(bb) of the Act, the cost performance category shall make up no more than 10 percent of the final score for the first MIPS payment year (CY 2019) and not more than 15 percent of the final score the second MIPS payment year (CY 2020). Therefore, we proposed at § 414.1350 that the cost performance category would make up 10 percent of the final score for the first MIPS payment year (CY 2019) and 15 percent of the final score for the second MIPS payment year (CY 2020) (81 FR 28384). As required by section 1848(q)(5)(E)(i)(II)(aa) of the Act and proposed at § 414.1350 (81 FR 28384), starting with the third MIPS payment year and for each MIPS payment year thereafter, the cost performance category would make up 30 percent of the final score.
The following is a summary of the comments we received regarding our proposals for the cost performance category weight in the final score for the first and second MIPS payment years.
In addition, as discussed in section II.E.6.a.(3) of this final rule with comment period, scoring for the cost performance category under MIPS is different from the VM because it is based on performance within a decile system as opposed to the quality-tiering scoring system used in the VM. A group or solo practitioner that scored in the average range under the VM quality-tiering methodology may be scored “above average” or “below average” in MIPS because of the difference in the scoring methods. We believe it is important for this transition year for MIPS eligible clinicians to have the opportunity to become familiar with the attribution changes and the scoring changes by receiving performance feedback showing what their performance on the cost measures will look like under the MIPS attribution and scoring rules before cost measures affects payment.
Section 1848(q)(5)(E)(i)(II)(bb) of the Act provides that for the first and second MIPS payment years, “not more than” 10 percent and 15 percent, respectively, of a MIPS eligible clinician's final score shall be based on performance in the cost performance category. Accordingly, we believe that the statute affords discretion to adopt a weighting for the cost performance category lower than 10 percent and 15 percent for the first and second payment years, respectively. For these reasons described above, we believe that a transition period would be appropriate; we are lowering the weight of the cost performance category for the first and second MIPS payment years. We are not finalizing our proposal for a weighting of 10 percent for the transition year and 15 percent for the second MIPS payment year. Instead we are finalizing a weighting of 0 percent for the transition year and 10 percent for the second MIPS payment year.
We are not reducing the weight of the cost category due to concerns with attribution, risk adjustment, or the measure specifications. We intend to continue improving all aspects of the cost measures, but we believe our final methods are sound. However, due to the changes in scoring and attribution, we
After consideration of the comments, we believe that a transition period for measuring cost would be appropriate; therefore, we are not finalizing the weighting of the cost performance category in the MIPS final score as proposed. Instead, we are finalizing at § 414.1350(b) a weighting of 0 percent for the 2019 MIPS payment year and 10 percent for the 2020 MIPS payment year. Starting with the 2021 MIPS payment year, the cost performance category will be weighted at 30 percent, as required by section 1848(q)(5)(E)(i)(II)(aa) of the Act. We recognize that the individual attribution of cost measures for those MIPS eligible clinicians in group practices and the new MIPS scoring system is a change for clinicians and we would like to give them an opportunity to gain experience with the cost measures before increasing the weight of the performance category within the final score.
As discussed in section II.E.5.a. of the proposed rule (81 FR 28181), performance in the cost performance category would be assessed using measures based on administrative Medicare claims data. We did not propose any additional data submissions for the cost performance category. As such, MIPS eligible clinicians and groups would be assessed based on cost for Medicare patients only and only for patients that are attributed to them. MIPS eligible clinicians or groups that do not have enough attributed cases to meet or exceed the case minimums proposed in sections II.E.5.e.(3)(a)(ii) and II.E.5.e.(3)(b)(ii) of the proposed rule would not be measured on cost. For more discussion of MIPS eligible clinicians and groups without a cost performance category score, please refer to II.E.6.a.(3)(d) and II.E.6.b.(2) of this final rule with comment period.
For purposes of assessing performance of MIPS eligible clinicians on the cost performance category, we proposed at § 414.1350(a) to specify cost measures for a performance period (81 FR 28384). For the CY 2017 MIPS performance period, we proposed to utilize the total per capita cost measure, the MSPB measure, and several episode-based measures discussed in section II.E.5.e.(3)(b). of the proposed rule (81 FR 28200) for the cost performance category. The total per capita costs measure and the MSPB measure are described in section II.E.5.e.(1)(c) of the proposed rule (81 FR 28197). We proposed including the total per capita cost measure as it is a global measure of all Medicare Part A and Part B resource use during the MIPS performance period and inclusive of the four condition-specific total per capita cost measures under the VM (chronic obstructive pulmonary disease, congestive heart failure, coronary artery disease, and diabetes mellitus) for which performance tends to be correlated and its inclusion was supported by commenters on the MIPS and APMs RFI (80 FR 59102 through 59113). We also anticipate that MIPS eligible clinicians are familiar with the total per capita cost measure as the measure has been in the VM since 2015 and feedback has been reported through the annual QRUR to all groups starting in 2014.
We proposed to adopt the MSPB measure because by the beginning of the initial MIPS performance period in 2017, we believe most MIPS eligible clinicians will be familiar with the measure in the VM or its variant under the Hospital Value-Based Purchasing (VBP) Program. However, we proposed two technical changes to the MSPB measure calculations for purposes of its adoption in MIPS which were discussed in the proposed rule at 81 FR 28200.
We proposed to use the same methodologies for payment standardization, and risk adjustment for these measures for the cost performance category as are defined for the VM. For more details on the previously adopted payment standardization methodology, see 77 FR 69316 through 69317. For more details on the previously adopted risk adjustment methodology, see 77 FR 69317 through 69318.
We did not propose to include the four condition-specific total per capita cost measures (chronic obstructive pulmonary disease, congestive heart failure, coronary artery disease, and diabetes mellitus). Instead, we generally proposed to assess performance in part using the episode-based measures (81 FR 28200). This shift is in response to feedback received as part of the MIPS and APMs RFI (80 FR 59102 through 59113). In the MIPS and APMs RFI, commenters stated that they do not believe the existing condition-specific total per capita cost measures under the VM are relevant to their practice and expressed support for episode-based measures under MIPS.
The following is summary of the comments we received regarding our proposal to include the total per capita cost measure and MSPB measure as cost measures.
In the VM, all cost measures are attributed to a TIN. In MIPS, however, we proposed to evaluate performance at the individual and group levels. Please refer to section II.E.5.e.(3)(c) of this rule for our discussion to address attribution differences for individuals and groups. For purposes of this section, we will use the general term MIPS eligible clinicians to indicate attribution for individuals or groups.
For the MSPB measure, we proposed to use attribution logic that is similar to what is used in the VM. MIPS eligible clinicians with the plurality of claims (as measured by allowed charges) for Medicare Part B services, rendered during an inpatient hospitalization that is an index admission for the MSPB measure during the applicable performance period would be assigned the episode. The only difference from the VM attribution methodology would be that the MSPB measure would be assigned differently for individuals than for groups. For the total per capita cost measure, we proposed to use a two-step attribution methodology that is similar to the methodology used in the 2017 and 2018 VM. We also proposed to have the same two-step attribution process for the claims-based population measures in the quality performance category (81 FR 28192), CMS Web Interface measures, and CAHPS for MIPS. However, we also proposed to make some modifications to the primary care services definition that is used in the attribution methodology to align with policies adopted under the Shared Savings Program.
The VM currently defines primary care services as the set of services identified by the following Healthcare Common Procedure Coding System (HCPCS)/CPT codes: 99201 through 99215, 99304 through 99340, 99341 through 99350, the welcome to Medicare visit (G0402), and the annual wellness visits (G0438 and G0439). We proposed to update this set to include new care coordination codes that have been implemented in the PFS: Transitional care management (TCM) codes (CPT codes 99495 and 99496) and the chronic care management (CCM) code (CPT code 99490). These services were added to the primary care service definition used by the Shared Saving Program in June 2015 (80 FR 32746 through 32748). We believe that these care coordination codes would also be appropriate for assigning services in the MIPS.
In the CY 2016 PFS final rule, the Shared Saving Program also finalized another modification to the primary care service definition: To exclude nursing visits that occur in a skilled nursing facility (SNF) (80 FR 71271 through 71272). Patients in SNFs (place of service (POS) 31) are generally shorter stay patients who are receiving continued acute medical care and rehabilitative services. While their care may be coordinated during their time in the SNF, they are then transitioned back to the community. Patients in a SNF (POS 31) require more frequent practitioner visits—often from 1 to 3 times a week. In contrast, patients in nursing facilities (NFs) (POS 32) are almost always permanent residents and generally receive their primary care services in the facility for the duration of their life. Patients in the NF (POS 32) are usually seen every 30 to 60 days unless medical necessity dictates otherwise. We believe that it would be appropriate to follow a similar policy in MIPS; therefore, we proposed to exclude services billed under CPT codes 99304 through 99318 when the claim includes the POS 31 modifier from the definition of primary care services.
We believe that making these two modifications would help align the primary care service definition between MIPS and Shared Savings Program and would improve the results from the two-step attribution process.
We note, however, that while we are aligning the definition for primary care services, the two-step attribution for MIPS would be different from the one used for the Shared Saving Program. We believe there are valid reasons to have differences between MIPS and the Shared Savings Program attribution. For example, as discussed in CY 2015 PFS final rule (79 FR 67960 through 67962), we eliminated the primary care service pre-step that is statutorily required for the Shared Savings Program from the VM. We noted that without the pre-step, the beneficiary attribution method would more appropriately reflect the multiple ways in which primary care services are provided, which are not limited to physician groups. As MIPS eligible clinicians include more than physicians, we continue to believe it is appropriate to exclude the pre-step.
In addition, in the 2015 Shared Savings Program final rule, we finalized a policy for the Shared Savings Program that we did not extend to the VM two-step attribution: To exclude select specialties (such as several surgical specialties) from the second attribution step (80 FR 32749 through 32754). We do not believe it is appropriate to restrict specialties from the second attribution step for MIPS. If such a policy were adopted under MIPS, then all specialists on the exclusion list, unless they were part of a multispecialty group, would automatically be excluded from measurement on the total per capita cost measure, as well as on claims-based population measures which rely on the same two-step attribution. While we do not believe that many MIPS eligible clinicians or groups with these specialties would be attributed enough cases to meet or exceed the case minimum, we believe that an automatic exclusion could remove some MIPS eligible clinicians
We requested comments on these proposed changes.
The following is a summary of the comments we received regarding our proposal to use the attribution methods from the VM for the MSPB and total per capita cost measure with changes to the definition of primary care services.
After considering comments, we are finalizing our proposal to use modified attribution methods from the VM for the total per capita cost measure and the MSPB. Specifically, we are also finalizing the removal of skilled nursing facility codes (CPT codes 99304-99318) from and addition of transitional care management (CPT codes 99495-99496) and chronic care management codes (CPT code 99490) to the list of primary care services used to attribute the total per capita cost measure. We believe that the changes to the attribution methodology allow us to better identify the clinician or group and the extent of accountability for total per capita cost.
We seek to ensure that MIPS eligible clinicians and groups are measured reliably; therefore, we intend to use the 0.4 reliability threshold currently applied to measures under the VM to evaluate their reliability. A 0.4 reliability threshold standard means that the majority of MIPS eligible clinicians and groups who meet the case minimum required for scoring under a measure have measure reliability scores that exceed 0.4. We generally consider reliability levels between 0.4 and 0.7 to indicate “moderate” reliability and levels above 0.7 to indicate “high” reliability. In cases where we have considered high participation in the applicable program to be an important programmatic objective, such as the Hospital VBP Program, we have selected this 0.4 moderate reliability standard. We believe this standard ensures moderate reliability, but does not substantially limit participation.
To ensure sufficient measure reliability for the cost performance category in MIPS, we also proposed at § 414.1380(b)(2)(ii) to use the minimum of 20 cases for the total per capita cost measure (81 FR 28386), the same case minimum that is being used for the VM. An analysis in the CY 2016 PFS final rule (80 FR 71282) confirms that this measure has high average reliability for solo practitioners (0.74) as well as for groups with more than 10 professionals (0.80).
In the CY 2016 PFS final rule, we finalized a policy that increases the minimum cases for the MSPB measure from 20 to 125 cases (80 FR 71295 through 71296) due to reliability concerns with the measure including the specialty adjustment. That said, we recognize that a case size increase of this nature also may limit the ability of MIPS eligible clinicians to be scored on the MSPB measure, and have been evaluating alternative measure calculation strategies for potential inclusion under MIPS that better balance participation, accuracy, and reliability. As a result of this, we
The first technical change we proposed was to remove the specialty adjustment from the MSPB measure's calculation. As currently reported on the QRURs, the MSPB measure is risk adjusted to ensure that these comparisons account for case-mix differences between practitioners' patient populations and the national average. It is unclear that the current additional adjustment for physician specialty improves the accounting for case-mix differences for acute care patients, and thus, may not be needed, and as our analysis below indicated, reliability for the measure improves when then adjustment is removed.
The second technical change we proposed was to modify the cost ratio used within the MSPB equation to evaluate the difference between observed and expected episode cost at the episode level before comparing the two at the individual or group level. In other words, rather than summing all of the observed costs and dividing by the sum of all the expected costs, we would take the observed to expected cost ratio for each MSPB episode assigned to the MIPS eligible clinician or group and take the average of the assigned ratios. As we did previously, we would take the average ratio for the MIPS eligible clinician or group and multiply it by the average of observed costs across all episodes nationally, in order to convert a ratio to a dollar amount.
Our analysis, which is based on all Medicare Part A and B claims data for beneficiaries discharged from an acute inpatient hospital between January 1, 2013 and December 1, 2013, indicates that these two changes would improve the MSPB measure's ability to calculate costs and the accuracy with which it can be used to make clinician-level performance comparisons. We also believe that these changes would help ensure the MSPB measure can be applied to a greater number of MIPS eligible clinicians while still maintaining its status as a reliable measure. More specifically, our analysis indicated that after making these changes to the MSPB measure's calculations, the MSPB measure meets the desired 0.4 reliability threshold used in the VM for over 88 percent of all TINs with a 20-case minimum, including solo practitioners. While this percentage is lower than our current policy for the VM (where virtually all TINs with 125 or more episodes have moderate reliability), setting the case minimum at 20 allows for an increase in participation in the MSPB measure. Therefore, we proposed to use a minimum of 20 cases for the MSPB measure (81 FR 28386). As noted previously, we consider expanded participation of MIPS eligible clinicians, particularly individual reporters, to be of great import for the purposes of transitioning to MIPS and believe that this justifies a slight decrease of the percentage of TINs meeting the reliability threshold.
We welcomed public comment on these proposals.
The following is summary of the comments we received regarding our proposals to use a 0.4 reliability threshold and a minimum of 20 cases for the total per capita cost measure.
We will finalize our reliability threshold of 0.4 but will continue to work to develop measures and improve specifications to ensure the highest level of reliability feasible within the cost measures in the MIPS program. We did not receive any specific comments on the our proposal to use a minimum of 20 cases for the total per capita cost measure. We are finalizing at § 414.1380(b)(2)(ii) that a MIPS eligible clinician must meet the minimum case volume specified by CMS to be scored on a cost measure. Therefore, a MIPS eligible clinician must have a minimum of 20 cases to be scored on the total per capta cost measure.
The following is a summary of the comments we received regarding our proposal to modify the case minimum for the MSPB, the proposal to remove the specialty adjustment from the MSPB measure's calculation, and the proposal to modify the cost ratio used within the MSPB equation.
We are finalizing at § 414.1380(b)(2)(ii) that a MIPS eligible clinician must meet the minimum case volume specified by CMS to be scored on a cost measure. Following our consideration of the comments, we are not finalizing our proposal of a minimum case volume of 20 for the MSPB measure. Instead, we are finalizing a minimum case volume of 35 for the MSPB. We are also adopting our proposals to not adjust the MSPB measure by specialty and to calculate observed to expected ratio at an episode level. We will continue to analyze the measure to ensure reliability.
As noted in the previous section, we proposed to calculate several episode-based measures for inclusion in the cost performance category. Groups have received feedback on their performance on episode-based measures through the Supplemental Quality and Resource Use Report (sQRUR), which are issued as part of the Physician Feedback Program under section 1848(n) of the Act; however, these measures have not been used for payment adjustments through the VM. Several stakeholders expressed in the MIPS and APMs RFI the desire to transition to episode-based measures and away from the general total per capita cost measures used in the VM. Therefore, in lieu of using the total per capita cost measures for populations with specific conditions that are used for the VM, we proposed episode-based measures for a variety of conditions and procedures that are high cost, have high variability in resource use, or are for high impact conditions. In addition, as these measures are payment standardized and risk adjusted, we believe they meet the statutory requirements for appropriate measures of cost as defined in section 1848(p)(3) of the Act because the methodology eliminates the effects of geographic adjustments in payment rates and takes into account risk factors.
We also reiterated that while we transition to using episode-based measures for payment adjustments, we will continue to engage stakeholders through the process specified in section 1848(r)(2) of the Act to refine and improve the episodes moving forward.
As noted earlier, we have provided performance information on episode-based measures to MIPS eligible clinicians through the sQRURs, which are released in the fall. The sQRURs provide groups and solo practitioners with information to evaluate their resource utilization on conditions and procedures that are costly and prevalent in the Medicare FFS population. To accomplish this goal, various episodes are defined and attributed to one or more groups or solo practitioners most responsible for the patient's care. The episode-based measures include Medicare Part A and Part B payments for services determined to be related to the triggering condition or procedure. The payments included are standardized to remove the effect of differences in geographic adjustments in payment rates and incentive payment programs and they are risk adjusted for the clinical condition of beneficiaries. Although the sQRURs provide detailed information on these care episodes, the calculations are not used to determine a TIN's VM payment adjustment and are only used to provide feedback.
We proposed to include in the cost performance category several clinical condition and treatment episode-based measures that have been reported in the sQRUR or were included in the list of the episode groups developed under section 1848(n)(9)(A) of the Act published on the CMS Web site:
While we proposed the measures listed in Tables 4 and 5 of the proposed rule for the cost performance category, we stated in the proposed rule that we were uncertain as to how many of these measures we would ultimately include in the final rule with comment period. As these measures have never been used for payment purposes, we indicated that we may choose to specify a subset of these measures in the final rule with comment period. We requested public comment on which of the measures listed in Tables 4 and 5 of the proposed rule to include in the final rule with comment period. In addition to considering public comments, we intended to consider the number of MIPS eligible clinicians able to be measured, the episode's impact on Medicare Part A and Part B spending, and whether the measure has been reported through sQRUR. In addition, while we do not believe specialty adjustment is necessary for the episode-based measures, we will continue to explore this further given the diversity of episodes. We solicited comment on whether we should specialty adjust the episode-based measures.
The following is summary of the comments we received regarding the episode-based measures proposed for the cost performance category for the CY 2017 performance period.
In addition, we intend to provide performance feedback to clinicians on additional episode-based measures that we are not finalizing for inclusion in the MIPS cost performance category for the CY 2017 performance period but may want to consider proposing for inclusion in the MIPS cost performance category in the future. Section 1848(q)(12)(A)(i) of the Act requires that we provide timely confidential feedback to MIPS eligible clinicians on their performance under the cost performance category. While the feedback on these additional episode-based measures would be for informational purposes only, we believe it will aid in MIPS eligible clinicians' ability to understand the measures and the attribution rules and methods that we use to calculate performance on these measures, which may be helpful in the event that we decide to propose the measures for the MIPS cost performance category in future rulemaking.
As discussed in the preceding response, we also intend to provide performance feedback to MIPS eligible clinicians under section 1848(q)(12)(A)(i) of the Act on additional episode-based measures for informational purposes only.
We appreciate the enthusiasm expressed by many commenters for the development of episode-based measures and their more nuanced focus on particular types of care. We also understand the concerns expressed regarding lack of familiarity with the episode-based measures. For this reason, we are modifying our proposal and finalizing for the CY 2017 performance period only 10 episode-based measures from the proposed rule. All of these measures were included in the 2014 sQRUR and meet the reliability threshold of 0.4 for the majority of clinicians and groups at a case minimum of 20. Table 7 includes the episode-based measures that are finalized for the CY 2017 performance period and includes their reliability, which we calculated using data from the 2015 sQRUR when the measure is attributed at the TIN level, as in the VM, and when attributed at the TIN/NPI level, as we will do under the MIPS program. The measures listed in Table 7 will be used (along with the total per capita cost measure and the MSPB measure finalized in this rule) to determine the cost performance category score. As we noted earlier, the weight of the cost category is 0 percent for 2019 MIPS payment year, therefore the performance category score will provide information to MIPS eligible clinicians, but performance will not affect the final score for the 2019 MIPS payment year.
In addition, for informational purposes, we intend to provide feedback to MIPS eligible clinicians under section 1848(q)(12)(A)(i) of the Act on the additional episode-based measures which may be introduced into MIPS in future years. We believe it will aid in MIPS eligible clinicians' ability to understand the measures and the attribution rules and methods that we use to calculate performance on these measures, which may be helpful in the event that we decide to propose the measures for the MIPS cost performance category in future rulemaking.
For the episode-based measures listed in Tables 4 and 5 of the proposed rule (81 FR 28202), we proposed to use the attribution logic used in the 2014 sQRUR (full description available at
Acute condition episode-based measures would be attributed to all MIPS eligible clinicians that bill at least 30 percent of inpatient evaluation and management (IP E&M) visits during the initial treatment, or “trigger event,” that opened the episode. E&M visits during the episode's trigger event represent services directly related to the management of the beneficiary's acute condition episode. MIPS eligible clinicians that bill at least 30 percent of IP E&M visits are therefore likely to have been responsible for the oversight of care for the beneficiary during the episode. It is possible for more than one MIPS eligible clinician to be attributed a single episode using this rule. If an acute condition episode has no IP E&M claims during the episode, then that episode is not attributed to any MIPS eligible clinician.
Procedural episodes would be attributed to all MIPS eligible clinicians that bill a Medicare Part B claim with a trigger code during the trigger event of the episode. For inpatient procedural episodes, the trigger event is defined as the IP stay that triggered the episode plus the day before the admission to the IP hospital. For outpatient procedural episodes constructed using Method A, the trigger event is defined as the day of the triggering claim plus the day before and 2 days after the trigger date. For outpatient procedural episodes constructed using Method B, the trigger event is defined as only the day of the triggering claim. Any Medicare Part B claim or line during the trigger event with the episode's triggering procedure code is used for attribution. If more than one MIPS eligible clinician bills a triggering claim during the trigger event, the episode is attributed to each of the MIPS eligible clinicians. If co-surgeons bill the triggering claim, the episode is attributed to each MIPS eligible
The following is a summary of the comments we received regarding our attribution methodology for the episode-based measures:
Following our consideration of the comments, we will finalize the attribution methodology for episode-based measures as proposed.
To ensure moderate reliability, we proposed at § 414.1380(b)(2)(ii) to use the minimum of 20 cases for all episode-based measures listed in Tables 4 and 5 of the proposed rule (81 FR 28386). We proposed to not include any measures that do not have average moderate reliability (at least 0.4) at 20 episodes.
Please see section II.E.5.e.(3)(b) for additional discussion of using 0.4 as the reliability threshold. All of the episode-based measures that we are finalizing are reliable at this threshold for 20 cases at both the individual and group level. We are finalizing at § 414.1380(b)(2)(ii) that a MIPS eligible clinician must meet the minimum case volume specified by CMS to be scored on a cost measure. After considering the comments, we are finalizing our proposal that a MIPS eligible clinician must have a minimum of 20 cases to be scored on an episode-based measure.
In the VM and sQRUR, all cost measurement was attributed at the solo practitioner and group level, as identified by the TIN. In MIPS, however, we proposed to evaluate performance at the individual and group levels. For MIPS eligible clinicians whose performance is being assessed individually across the other MIPS performance categories, we proposed to attribute cost measures using the TIN/NPI rather than the TIN. Attribution at the TIN/NPI level allows individual MIPS eligible clinicians, as identified by their TIN/NPI, to be measured based on cases that are specific to their practices, rather than being measured on all the cases attributed to the group TIN. For MIPS eligible clinicians that choose to have their performance assessed as a group across the other MIPS performance categories, we proposed to attribute cost measures at the TIN level (the group TIN under which they report). The logic for attribution would be similar whether attributing to the TIN/NPI level or the TIN level. As an alternative proposal, we solicited comment on whether MIPS eligible clinicians that choose to have their performance assessed as a group should first be attributed at the individual TIN/NPI level and then have all cases assigned to the individual TIN/NPIs attributed to the group under which they bill. This alternative would apply one consistent methodology to both groups and individuals, compared to having a methodology that assigns cases using TIN/NPI for assessment at the individual level and another that assigns cases using only TIN for assessment at the group level. For example, the general attribution logic for the MSPB is to assign the MSPB measure based on the plurality of claims (as measured by allowed charges) for Medicare Part B services rendered during an inpatient hospitalization that is an index admission for the MSPB measure. Our proposed approach would determine “plurality of claims” separately for individuals and groups. For individuals, we would assign the MSPB measure using the “plurality of claims” by TIN/NPI, but for groups we would determine the “plurality of
We requested comment on this proposal and alternative considered.
To reduce complexity in the MIPS program, we are finalizing the alternative proposal to attribute cost measures for all clinicians at the TIN/NPI level. For those groups that participate in group reporting in other MIPS performance categories, their cost performance category scores will be determined by aggregating the scores of the individual clinicians within the TIN. For example, if a TIN had one surgeon that billed for 11 codes and another surgeon in that TIN billed for 12 codes that would trigger the knee arthroplasty episode-based measure, neither surgeon would have enough cases to be measured individually. However, if the TIN elects group reporting, the TIN would be assessed on the 23 combined cases.
Section 101(c) of the MACRA added section 1848(q)(2)(C)(iv) to the Act, which requires the Secretary to give consideration to the circumstances of professional types who typically furnish services without patient facing interaction (non-patient facing) when determining the application of measures and activities. In addition, this section allows the Secretary to apply alternative measures or activities to non-patient facing MIPS eligible clinicians that fulfill the goals of a performance category. Section 101(c) of the MACRA also added section 1848(q)(5)(F) to the Act, which allows the Secretary to re-weight MIPS performance categories if there are not sufficient measures and activities applicable and available to each type of MIPS eligible clinician involved.
For the 2017 MIPS performance period, we did not propose any alternative measures for non-patient facing MIPS eligible clinicians or groups. This means that non-patient facing MIPS eligible clinicians or groups may not be attributed any cost measures that are generally attributed to clinicians who have patient facing encounters with patients. We therefore anticipate that, similar to MIPS eligible clinicians or groups that do not meet the required case minimum for any cost measures, many non-patient facing MIPS eligible clinicians may not have sufficient measures and activities available to report and would not be scored on the cost performance category under MIPS. We refer readers to section II.E.6.b.2. of this final rule with comment period where we discussed how we would address performance category weighting for MIPS eligible clinicians or groups who do not receive a performance category score for a given performance category. We also intend to work with non-patient facing MIPS eligible clinicians and specialty societies to propose alternative cost measures for non-patient facing MIPS eligible clinicians and groups under MIPS in future years. Lastly, we solicited comment on how best to incorporate appropriate alternative cost measures for all MIPS eligible clinician types, including non-patient facing MIPS eligible clinicians.
The following is summary of the comments we received.
We appreciate the comments received and will attribute cost measures to non-patient facing MIPS eligible clinicians who have sufficient case volume, in accordance with the attribution methodology.
Section 1848(q)(2)(C)(ii) of the Act, as added by section 101(c) of MACRA provides that the Secretary may use measures used for a payment system other than for physicians, such as measures for inpatient hospitals, for purposes of the quality and cost performance categories of MIPS. The Secretary, however, may not use measures for hospital outpatient departments, except in the case of items and services furnished by emergency physicians, radiologists, and anesthesiologists.
We intend to align any facility-based MIPS measure decision across the quality and cost performance categories to ensure consistent policies for MIPS in future years. We refer readers back to section II.E.5.b.(5) of this rule which discusses our strategy and solicits comments related to this provision. Below is our response to comments related to measuring the cost of facility-based clinicians.
We appreciate the comments and will take all comments into consideration as we develop future cost measures.
In the future, we intend to consider how best to incorporate Medicare Part D costs into the cost performance category, as described in section 1848(q)(2)(B)(ii) of the Act. We solicited public comments on how we should incorporate those costs under MIPS for future years. We also intend to continue developing and refining episode-based measures for purposes of cost performance category measure calculations.
The following is summary of the comments we received regarding the inclusion of Medicare Part D costs within cost measurement.
We appreciate the comments and will take all comments into consideration as we develop future cost measures.
The improvement activities performance category focuses on one of our MIPS strategic goals, to use a patient-centered approach to program development that leads to better, smarter, and healthier care. We believe improving the health of all Americans can be accomplished by developing incentives and policies that drive improved patient health outcomes. Improvement activities emphasize activities that have a proven association with better health outcomes. The improvement activities performance category also focuses on another MIPS strategic goal which is to use design incentives that drive movement toward delivery system reform principles and participation in APMs. A further MIPS strategic goal we are striving to achieve is to establish policies that can be scaled in future years as the bar for improvement rises. Under the improvement activities performance category, we proposed baseline requirements that will continue to have more stringent requirements in future years, and lay the groundwork for expansion towards continuous improvement over time.
Section 1848(q)(2)(C)(v)(III) of the Act defines an improvement activity as an activity that relevant eligible clinician organizations and other relevant stakeholders identify as improving clinical practice or care delivery, and that the Secretary determines, when effectively executed, is likely to result in improved outcomes. Section 1848(q)(2)(B)(iii) of the Act requires the Secretary to specify improvement activities under subcategories for the performance period, which must include at least the subcategories specified in section 1848(q)(2)(B)(iii)(I) through (VI) of the Act, and in doing so to give consideration to the circumstances of small practices, and practices located in rural areas and geographic health professional shortage areas (HPSAs).
Section 1848(q)(2)(C)(iv) of the Act generally requires the Secretary to give consideration to the circumstances of non-patient facing MIPS eligible clinicians or groups and allows the Secretary, to the extent feasible and appropriate, to apply alternative measures and activities to such MIPS eligible clinicians and groups.
Section 1848(q)(2)(C)(v) of the Act required the Secretary to use a request for information (RFI) to solicit recommendations from stakeholders to identify improvement activities and specify criteria for such improvement activities, and provides that the Secretary may contract with entities to assist in identifying activities, specifying criteria for the activities, and determining whether MIPS eligible clinicians or groups meet the criteria set. In the MIPS and APMs RFI, we requested recommendations to identify activities and specify criteria for activities. In addition, we requested details on how data should be submitted, the number of activities, how performance should be measured, and what considerations should be made for small or rural practices. There were two overarching themes from the comments that we received in the MIPS and APMs RFI. First, the majority of the comments indicated that all subcategories should be weighted equally and that MIPS eligible clinicians or groups should be allowed to select from whichever subcategories are most applicable to them during the performance period. Second, commenters supported inclusion of a diverse set of activities that are meaningful for individual MIPS eligible clinicians or groups. We have reviewed all of the comments that we received and took these recommendations into consideration
We are finalizing at § 414.1305 the definition of improvement activities, as proposed, to mean an activity that relevant MIPS eligible clinician, organizations and other relevant stakeholders identify as improving clinical practice or care delivery and that the Secretary determines, when effectively executed, is likely to result in improved outcomes.
Section 1848(q)(5)(E)(i)(III) of the Act specifies that the improvement activities performance category will account for 15 percent of the final score, subject to the Secretary's authority to assign different scoring weights under section 1848(q)(5)(F) of the Act. Therefore, we proposed at § 414.1355, that the improvement activities performance category would account for 15 percent of the final score.
Section 1848(q)(5)(C)(i) of the Act specifies that a MIPS eligible clinician or group that is certified as a patient-centered medical home or comparable specialty practice, as determined by the Secretary, must be given the highest potential score for the improvement activities performance category for the performance period. For a further description of APMs that have a certified patient centered-medical home designation, we refer readers to the proposed rule (81 FR 28234).
A patient-centered medical home would be recognized if it is a nationally recognized accredited patient-centered medical home, a Medicaid Medical Home Model, or a Medical Home Model. The NCQA Patient-Centered Specialty Recognition would also be recognized, which qualifies as a comparable specialty practice. Nationally recognized accredited patient-centered medical homes are recognized if they are accredited by: (1) The Accreditation Association for Ambulatory Health Care; (2) the National Committee for Quality Assurance (NCQA) patient-centered medical home recognition; (3) The Joint Commission Designation; or (4) the Utilization Review Accreditation Commission (URAC).
Section 1848(q)(5)(C)(ii) of the Act provides that MIPS eligible clinicians or groups who are participating in an APM (as defined in section 1833(z)(3)(C) of the Act) for a performance period must earn at least one half of the highest potential score for the improvement activities performance category for the performance period. For further description of improvement activities and the APM scoring standard for MIPS, we refer readers to the proposed rule (81 FR 28234). For all other MIPS eligible clinicians or groups, we refer readers to the scoring requirements for MIPS eligible clinicians and groups in the proposed rule (81 FR 28247).
Section 1848(q)(5)(C)(iii) of the Act provides that a MIPS eligible clinician or group must not be required to perform activities in each improvement activities subcategory or participate in an APM to achieve the highest potential score for the improvement activities performance category.
Section 1848(q)(5)(B)(i) of the Act requires the Secretary to treat a MIPS eligible clinician or group that fails to report on an applicable measure or activity that is required to be reported, they will receive the lowest potential score applicable to the measure or activity.
The following is a summary of the comments we received regarding the improvement activities performance category contribution to the final score.
While we believe that some of the advanced primary care functions in the Joint Principles of the Patient-Centered Medical Home and key functions of the Comprehensive Primary Care Initiative might count as improvement activities there is a distinction maintained between being an actual certified patient-centered medical home per the statute and performing some functions of one. Therefore, performing these functions alone would not qualify for full credit. Other certifications that are not for patient-centered medical homes or comparable specialty practices would also not qualify automatically for the highest score.
MIPS eligible clinicians and groups that receive certification from other accreditation organizations that certify for a patient-centered medical home or comparable specialty practice, including accredited organizations that receive deeming authority from CMS, such as The Compliance Team, would receive full credit as long as those accredited bodies meet the two criteria. These two criteria are: (1) The accredited body must have certified 500 or more member practices as a patient-centered medical home or comparable practice; and (2) they must meet national guidelines.
After consideration of the comments regarding the contribution to final score we are finalizing at § 414.1355, that the improvement activities performance category would account for 15 percent of the final score. We are not finalizing our policy on recognizing only practices that have received nationally recognized accredited or certified-patient centered
For the purpose of submitting under the improvement activities performance category, we proposed in the proposed rule (81 FR 28181) to allow for submission of data for the improvement activities performance category using the qualified registry, EHR, QCDR, CMS Web Interface, and attestation data submission mechanisms. If technically feasible, we would use administrative claims data to supplement the improvement activities submission. Regardless of the data submission method, all MIPS eligible clinicians or groups must select activities from the improvement activities inventory provided in Table H in in the Appendix to this final rule with comment period. We believe the proposed data submission methods would allow for greater access and ease in submitting data, as well as consistency throughout the MIPS program.
In addition, we proposed at § 414.1360, that for the transition year only, all MIPS eligible clinicians or groups, or third party intermediaries such as health IT intermediaries, QCDRs and qualified registries that submit on behalf of a MIPS eligible clinician or group, must designate a yes/no response for activities on the improvement activities inventory. In the case where a MIPS eligible clinician or group is using a health IT intermediary, QCDR, or qualified registry for their data submission, the MIPS eligible clinician or group will certify all improvement activities have been performed and the health IT intermediary, QCDR, or qualified registry will submit on their behalf. An agreement between a MIPS eligible clinician or group and a health IT vendor, QCDR, or qualified registry for data submission for improvement activities as well as other performance data submitted outside of the improvement activities performance category could be contained in a single agreement, minimizing the burden on the MIPS eligible clinician or group. See the proposed rule (81 FR 28281) for additional details.
We proposed to use the administrative claims method, if technically feasible, only to supplement improvement activities performance category submissions. For example, if technically feasible, MIPS eligible clinicians or groups, using the telehealth modifier GT, could get automatic credit for this activity. We requested comments on these proposals.
The following is a summary of the comments we received regarding the improvement activities performance category data submission criteria and mechanisms.
After consideration of the comments received regarding the improvement activities data submission criteria we are not finalizing the policies as proposed. Specifically, we are not finalizing the data submission method of administrative claims data to supplement the improvement activities as it is not technically feasible at this time.
We are finalizing at § 414.1360 to allow for submission of data for the improvement activities performance category using the qualified registry, EHR, QCDR, CMS Web Interface, and attestation data submission mechanisms. Regardless of the data submission method, with the exception of MIPS APMs, all MIPS eligible clinicians or groups must select activities from the improvement activities inventory provided in Table H in in the Appendix to this final rule with comment period.
In addition, we are finalizing at § 414.1360 that for the transition year of MIPS, all MIPS eligible clinicians or groups, or third party intermediaries such as health IT vendors, QCDRs and qualified registries that submit on behalf of a MIPS eligible clinician or group, must designate a yes response for activities on the improvement activities inventory. In the case where a MIPS eligible clinician or group is using a health IT vendor, QCDR, or qualified registry for their data submission, the MIPS eligible clinician or group will certify all improvement activities have been performed and the health IT vendor, QCDR, or qualified registry will submit on their behalf.
We are also including a designation column in the improvement activities inventory that will show which activities qualify for the advancing care information bonus finalized at § 414.1380 and refer readers to Table H in in the Appendix to this final rule with comment period.
While we considered both equal and differentially weighted scoring in this performance category, the statute requires a differentially weighted scoring model by requiring 100 percent of the potential score in the improvement activities performance category for patient-centered medical home participants, and a minimum 50 percent score for APM participants. For additional activities in this category, we proposed at § 414.1380 a differentially weighted model for the improvement activities performance category with two categories: Medium and high. The justification for these two weights is to provide flexible scoring due to the undefined nature of activities (that is, improvement activities standards are not nationally recognized and there is no entity for improvement activities that serves the same function as the NQF does for quality measures). Improvement activities are weighted as high based on alignment with our national public health priorities and programs such as the Quality Innovation Network-Quality Improvement Organization (QIN/QIO) or the Comprehensive Primary Care Initiative which recognizes specific activities related to expanded access and integrated behavioral health as important priorities. Programs that require performance of multiple activities such as participation in the Transforming Clinical Practice Initiative, seeing new and follow-up Medicaid patients in a timely manner in the clinician's state Medicaid Program, or an activity identified as a public health priority (such as emphasis on anticoagulation management or utilization of prescription drug monitoring programs) were weighted as high.
The statute references certified patient-centered medical homes as achieving the highest score for the MIPS program. MIPS eligible clinicians or groups may use that to guide them in the criteria or factors that should be taken into consideration to determine whether to weight an activity medium or high. We requested comments on this proposal, including criteria or factors we should take into consideration to determine whether to weight an activity medium or high.
The following is a summary of the comments we received regarding weighted scoring for improvement activities.
After consideration of the comments regarding weighted scoring we are finalizing at § 414.1380 a differentially weighted model for the improvement activities performance category with two categories: Medium and high. We refer readers to the following sections of this final rule with comment period in reference to the improvement activities performance category: Section VI.H for the modified list of high-weighted and medium-weighted activities, section II.E.5.f.(3)(c) for information on the number of activities required to achieve the highest score, section II.E.6.a.(4)(a) for information on how points will be assigned, section II.E.6.a.(4)(b) how the highest potential score can be achieved, section II.E.6.a.(4)(c) on how we will recognize a MIPS eligible clinician or group for qualifying for the points for a certified patient-centered medical home or comparable specialty practices, and section II.E.6.a.(4)(d) for how the improvement performance activities will be calculated.
We proposed at § 414.1380 to set the improvement activities submission criteria under MIPS, to achieve the highest potential score of 100 percent, at three high-weighted improvement activities (20 points each) or six medium-weighted improvement activities (10 points each), or some combination of high and medium-weighted improvement activities to achieve a total of 60 points for MIPS eligible clinicians participating as individuals or as groups (refer to Table H in in the Appendix to this final rule with comment period for improvement activities and weights). MIPS eligible clinicians or groups that select less than the designated number of improvement activities will receive partial credit based on the weighting of the improvement activity selected. To achieve a 50 percent score, one high-weighted and one medium-weighted improvement activity or three medium-weighted improvement activities are required for these MIPS eligible clinicians or groups.
Exceptions to the above apply for: Small practices, MIPS eligible clinicians and groups located in rural areas, MIPS eligible clinicians and groups that are located in geographic HPSAs, non-patient facing MIPS eligible clinicians or groups or MIPS eligible clinicians, or groups that participate in an APM or a patient-centered medical home submitting in MIPS.
For MIPS eligible clinicians and groups that are small practices, located in rural areas or geographic HPSAs, or non-patient facing MIPS eligible clinicians or groups, to achieve the highest score of 100 percent, two improvement activities are required (either medium or high). For MIPS eligible clinicians or groups that are small practices, located in rural areas, located in HPSAs, or non-patient facing MIPS eligible clinicians or groups, in order to achieve a 50 percent score, one improvement activity is required (either medium or high).
MIPS eligible clinicians or groups that participate in APMs are considered eligible to participate under the improvement activities performance category unless they are participating in an Advanced APM and they have met the Qualifying APM Participant (QP) thresholds or are Partial QPs that elect not to report information. A MIPS eligible clinician or group that is participating in an APM and participating under the improvement activities performance category will receive one half of the total improvement activities score just through their APM participation. These are MIPS eligible clinicians or groups that we identify as participating in APMs for MIPS and may participate under the improvement activities performance category. To achieve the total improvement activities score, such MIPS eligible clinicians or groups will need to identify that they participate in an APM and this APM will submit the eligible clinicians' improvement activities score for that specific model type.
For further description of MIPS eligible clinicians or groups that are required to report to MIPS under the APM scoring standard and their improvement activities scoring requirements, we refer readers to the proposed rule (81 FR 28234). For all other MIPS eligible clinicians or groups participating in APMs that would report to MIPS, this section applies and we also refer readers to the scoring requirements for these MIPS eligible clinicians or groups in the proposed rule (81 FR 28237).
Since we cannot measure variable performance within a single improvement activity, we proposed at § 414.1380 to compare the improvement activities points associated with the reported activities against the highest number of points that are achievable under the improvement activities performance category which is 60 points. We proposed that the highest potential score of 100 percent can be achieved by selecting a number of activities that will add up to 60 points. MIPS eligible clinicians and groups, including those that are participating as an APM, and all those that select activities under the improvement activities performance category can achieve the highest potential score of 60 points by selecting activities that are equal to the 60-point maximum. We refer readers to the scoring section of the proposed rule (81 FR 28237) for additional rationale for using 60 points for the transition year of MIPS.
If a MIPS eligible clinician or group reports only one improvement activity, we would score that activity accordingly, as 10 points for a medium-level activity or 20 points for a high-level activity. If a MIPS eligible clinician or group reports no improvement activities, then the MIPS eligible clinician or group would receive a zero score for the improvement activities performance category. We
In addition, we believe these are reasonable criteria for MIPS eligible clinicians or groups to accomplish within the transition year for three reasons: (1) In response to several stakeholder MIPS and APMs RFI comments, we are not recommending a minimum number of hours for performance of an activity; (2) we are offering a broad list of activities from which MIPS eligible clinicians or groups may select; and (3) also in response to MIPS and APMs RFI comments, we proposed that an activity must be performed for at least 90 days during the performance period for improvement activities credit. We intend to reassess this requirement threshold in future years. We do not believe it is appropriate to require a determined number of activities within a specific subcategory at this time. This proposal aligns with the requirements in section 1848(q)(2)(C)(iii) of the Act that states MIPS eligible clinicians or groups are not required to perform activities in each subcategory.
Lastly, we recognize that working with a QCDR could allow a MIPS eligible clinician or group to meet the measure and activity criteria for multiple improvement activities. For the transition year of MIPS, there are several improvement activities in the inventory that incorporate QCDR participation. Each activity must be selected and achieved separately for the transition year of MIPS. A MIPS eligible clinician or group cannot receive credit for multiple activities just by selecting one activity that includes participation in a QCDR. As the improvement activities inventory expands over time we were interested in receiving comments on what restrictions, if any, should be placed around improvement activities that incorporate QCDR participation.
The following is a summary of the comments we received regarding submission criteria.
After consideration of the comments received regarding the submission criteria, we are not finalizing the policies as proposed. Rather, we are reducing the maximum number of activities required to achieve the highest possible score in this performance category. Specifically, we are finalizing at § 414.1380 to set the improvement activities submission criteria under MIPS, to achieve the highest potential score, at two high-weighted improvement activities or 4 medium-weighted improvement activities, or some combination of high and medium-weighted improvement activities which will be less than four total number of activities for MIPS eligible clinicians participating as individuals or as groups (refer to Table H in in the Appendix to this final rule with comment period for improvement activities and weights).
Exceptions to the above apply for: Small practices, located in rural areas, practices located in geographic HPSAs, non-patient facing MIPS eligible clinicians or groups or MIPS eligible clinicians, or groups that participate in a MIPS APM or a patient-centered medical home submitting in MIPS. As discussed in sections II.E.5.h. and II.E.6. of this final rule with comment period, we are reducing the maximum number of activities required for these MIPS eligible clinicians and groups to achieve the highest possible score in this performance category.
Specifically, for MIPS eligible clinicians and groups that are small practices, practices located in rural areas or geographic HPSAs, or non-patient facing MIPS eligible clinicians or groups, to achieve the highest score, one high-weighted or two medium-weighted improvement activities are required. For these MIPS eligible clinicians and groups, in order to achieve one-half of the highest score, one medium-weighted improvement activity is required.
We will also provide full credit for the improvement activities performance category for a MIPS eligible clinician or group that has received certification or accreditation as a patient-centered medical home or comparable specialty practice from a national program or from a regional or state program, private payer or other body that administers patient-centered medical home accreditation and certifies 500 or more practices for patient-centered medical home accreditation or comparable specialty practice certification.
We believe that this approach is appropriate for the transition year of MIPS since this is a new performance category of requirements for MIPS eligible clinicians and we want to ensure all MIPS eligible clinicians understand what is required of them, while not being overly burdensome.
All clinicians identified on the Participation List of an APM receive at least one-half of the highest score. To develop the improvement activities additional score assigned to all MIPS APMs, CMS will compare the requirements of the specific APM with the list of activities in the Improvement Activities Inventory in Table H in in the Appendix to this final rule with comment period and score those activities in the same manner that they are otherwise scored for MIPS eligible clinicians according to section II.E.6.a.(4) of this final rule with comment period. For further explanation of how MIPS APMs scores will be calculated, we refer readers to section II.E.5.h of this final rule with comment period. Should the MIPS APM not receive the maximum improvement activities performance category score then the APM entity can submit additional improvement activities. All other MIPS eligible clinicians or groups that we identify as participating in APMs will need to select additional improvement activities to achieve the improvement activities highest score.
We proposed § 414.1360 that MIPS eligible clinicians or groups must perform improvement activities for at least 90 days during the performance period for improvement activities credit. We understand there are some activities that are ongoing whereas others may be episodic. We considered setting the threshold for the minimum time required for performing an activity to longer periods up to a full calendar year. However, after researching several organizations we believe a minimum of 90 days is a reasonable amount of time. One illustrative example of organizations that used 90 days as a window for reviewing clinical practice improvements are practice improvement activities undertaken by a large Veteran's Administration health care program that set a 90-day window for reviewing improvements in the management of opioid dispensing.
Additional clarification for how some activities meet the 90-day rule or if additional time is required are reflected in the description of that activity in Table H in in the Appendix to this final rule with comment period. In addition, we proposed that activities, where applicable, may be continuing (that is, could have started prior to the performance period and are continuing) or be adopted in the performance period as long as an activity is being performed for at least 90 days during the performance period.
We anticipate in future years that extended improvement activities time periods will be needed for certain activities. We will monitor the time period requirement to assess if allowing for extended time requirements may enhance the value associated with generating more effective outcomes, or conversely, the extended time may reveal that more time has little or no value added for certain activities when associated with desired outcomes. We requested comments on this proposal.
The following is a summary of the comments we received regarding the required period of time for performing an activity.
We do not believe that reporting periods as short as 30 days are sufficient to ensure that the activities being performed are robust enough to result in actual practice improvements. However, we are also cognizant of the inherent challenges associated with implementing new improvement activities, which is why we are finalizing our requirement that these activities be performed during a continuous 90-day period during the performance period. We view that reporting period as an appropriate balance for the transition year of MIPS, and will re-examine reporting periods for improvement activities in the future.
After consideration of the comments regarding the required period of time for performing an activity, we are finalizing at § 414.1360 that MIPS eligible clinicians or groups must perform improvement activities for at least 90 consecutive days during the performance period for improvement activities performance category credit. Activities, where applicable, may be continuing (that is, could have started prior to the performance period and are continuing) or be adopted in the performance period as long as an activity is being performed for at least 90 days during the performance period.
We understand that non-patient facing MIPS eligible clinicians and groups may have a limited number of measures and activities to report. Therefore, we proposed at § 414.1360 allowing non-patient facing MIPS eligible clinicians and groups to report on a minimum of one activity to achieve partial credit or two activities to achieve full credit to meet the improvement activities submission criteria. These non-patient facing MIPS eligible
We anticipate the number of activities for non-patient facing MIPS eligible clinicians or groups will increase in future years as we gather more data on the feasibility of performing improvement activities. As part of the process for identifying activities, we consulted with several organizations that represent a cross-section of non-patient facing MIPS eligible clinicians and groups. An illustrative example of those consulted with include organizations that represent cardiologists involved in nuclear medicine, nephrologists who serve only in a consulting role to other clinicians, or pathologists who, while they typically function as a team, have different members that perform different roles within their specialty that are primarily non-patient facing.
In the course of those discussions these organizations identified improvement activities they believed would be applicable. The comments on activities appropriate for non-patient facing MIPS eligible clinicians or groups are reflected in the proposed improvement activities inventory across multiple subcategories. For example, several of these organizations suggested consideration for Appropriate Use Criteria (AUC). As a result, we have incorporated AUC into some of the activities. We encourage MIPS eligible clinicians or groups who are already required to use AUC (for example, for advanced imaging) to report an improvement activity other than one related to appropriate use. Another example, under Patient Safety and Practice Assessment, is the implementation of an antibiotic stewardship program that measures the appropriate use of antibiotics for several different conditions (Upper Respiratory Infection (URI) treatment in children, diagnosis of pharyngitis, and bronchitis treatment in adults) according to clinical guidelines for diagnostics and therapeutics. In addition, we requested comments on what activities would be appropriate for non-patient facing MIPS eligible clinicians or groups to add to the improvement activities inventory in the future. We requested comments on this proposal.
The following is a summary of the comments we received regarding the application of improvement activities to non-patient facing MIPS eligible clinicians and groups.
After consideration of the comments regarding the application of improvement activities to non-patient facing MIPS eligible clinicians and groups we are not finalizing the policies as proposed. Rather, based on commenters' feedback, we believe that it is appropriate to reduce the number of activities that a non-patient facing MIPS eligible clinician must select to achieve credit to meet the improvement activities data submission criteria. Specifically, we are finalizing at § 414.1380 that for non-patient facing MIPS eligible clinicians or groups, to achieve the highest score one high-weighted or two medium-weighted improvement activities are required. For these MIPS eligible clinicians and groups, in order to achieve one-half of the highest score, one medium-weighted improvement activity is required.
Section 1848(q)(2)(B)(iii) of the Act requires the Secretary, in establishing improvement activities, to give consideration to small practices and practices located in rural areas as defined at § 414.1305 and in geographic based HPSAs as designated under section 332(a)(1)(A) of the Public Health Service Act. In the MIPS and APMs RFI, we requested comments on how improvement activities should be applied to MIPS eligible clinicians or groups in small practices, in rural areas, and geographic HPSAs: if a lower performance requirement threshold or different measures should be established that will better allow those MIPS eligible clinicians or groups to perform well in this performance category, what methods should be leveraged to appropriately identify these practices, and what best practices should be considered to develop flexible and adaptable improvement activities based on the needs of the community and its population.
We engaged high performing organizations, including several rural health clinics with 15 or fewer clinicians that are designated as geographic HPSAs, to provide feedback on relevant activities based on their specific circumstances. Some examples provided include participation in implementation of self-management programs such as for diabetes, and early use of telemedicine, as in the one case for a top performing multi-specialty rural practice that covers 20,000 people over a 25,000-mile radius in a rural area of North Dakota. Comments on activities appropriate for MIPS eligible clinicians or groups located in rural areas or practices that are designated as geographic HPSAs are reflected in the proposed improvement activities inventory across multiple subcategories.
After consideration of comments and listening sessions, we proposed at § 414.1360 to accommodate small practices and practices located in rural areas, or geographic HPSAs for the
The following is a summary of the comments we received regarding special consideration for MIPS small practices, or practices located in rural areas or geographic HPSAs.
After consideration of the comments regarding special consideration for small practices, rural, or geographic HPSAs practices we are not finalizing the policies as proposed. Rather, based on stakeholders' feedback, we believe that it is appropriate to reduce the required number of activities required to achieve full credit in this performance category for small practices, rural, or health professional shortage areas practices. Specifically, we are finalizing at § 414.1380 that for MIPS eligible clinicians and groups that are small practices or located in rural areas, or geographic HPSAs, to achieve full credit, one high-weighted or two medium-weighted improvement activities are required. In addition, we are modifying our proposed definition of rural area and finalizing at § 414.1305 that a rural area means clinicians in zip codes designated as rural, using the most recent HRSA Area Health Resource File data set available. We proposed using HRSA's 2014-2015 Area Resource File but decided a non-specific reference would be more broadly applicable. In addition, we are finalizing the following definitions, as proposed, at § 414.1305: (1) small practices means practices consisting of 15 or fewer clinicians and solo practitioners; and (2) Health Professional Shortage Areas (HPSA) means areas as designated under section 332(a)(1)(A) of the Public Health Service Act.
We refer readers to section II.E.6.a.(4) of this final rule with comment period for a more detailed explanation of the number of points and scoring for the improvement activities performance category.
Section 1848(q)(2)(B)(iii) of the Act provides that the improvement activities performance category must include at least the subcategories listed below. The statute also provides the Secretary discretion to specify additional subcategories for the improvement activities performance category, which have also been included below.
• Expanded practice access, such as same day appointments for urgent needs and after-hours access to clinician advice.
• Population management, such as monitoring health conditions of individuals to provide timely health care interventions or participation in a QCDR.
• Care coordination, such as timely communication of test results, timely exchange of clinical information to patients and other MIPS eligible clinicians or groups, and use of remote monitoring or telehealth.
• Beneficiary engagement, such as the establishment of care plans for individuals with complex care needs, beneficiary self-management assessment and training, and using shared decision-making mechanisms.
• Patient safety and practice assessment, such as through the use of clinical or surgical checklists and practice assessments related to maintaining certification.
• Participation in an APM, as defined in section 1833(z)(3)(C) of the Act.
In the MIPS and APMs RFI, we requested recommendations on the inclusion of the following five potential new subcategories:
• Promoting Health Equity and Continuity, including (a) serving Medicaid beneficiaries, including individuals dually eligible for Medicaid and Medicare, (b) accepting new Medicaid beneficiaries, (c) participating in the network of plans in the Federally Facilitated Marketplace or state exchanges, and (d) maintaining adequate equipment and other accommodations (for example, wheelchair access, accessible exam tables, lifts, scales, etc.) to provide comprehensive care for patients with disabilities.
• Social and Community Involvement, such as measuring completed referrals to community and social services or evidence of partnerships and collaboration with the community and social services.
• Achieving Health Equity, such as for MIPS eligible clinicians or groups that achieve high quality for underserved populations, including persons with behavioral health conditions, racial and ethnic minorities, sexual and gender minorities, people with disabilities, people living in rural areas, and people in geographic HPSAs.
• Emergency preparedness and response, such as measuring MIPS eligible clinician or group participation in the Medical Reserve Corps, measuring registration in the Emergency System for Advance Registration of Volunteer Health Professionals, measuring relevant reserve and active duty uniformed services MIPS eligible clinician or group activities, and measuring MIPS eligible clinician or group volunteer participation in domestic or international humanitarian medical relief work.
• Integration of primary care and behavioral health, such as measuring or evaluating such practices as: Co-location of behavioral health and primary care services; shared/integrated behavioral health and primary care records; or cross-training of MIPS eligible clinicians or groups participating in integrated care. This subcategory also includes integrating behavioral health with primary care to address substance use disorders or other behavioral health conditions, as well as integrating mental health with primary care.
We recognize that quality improvement is a critical aspect of
Therefore, for the transition year of MIPS, we proposed at § 414.1365 that the improvement activities performance category include the subcategories of activities provided at section 1848(q)(2)(B)(iii) of the Act. In addition, we proposed at § 414.1365 adding the following subcategories: “Achieving Health Equity,” “Integrated Behavioral and Mental Health,” and “Emergency Preparedness and Response.” In response to multiple MIPS and APMs RFI comments requesting the inclusion of “Achieving Health Equity,” we proposed to include this subcategory because: (1) It is important and may require targeted effort to achieve and so should be recognized when accomplished; (2) it supports our national priorities and programs, such as Reducing Health Disparities; and (3) it encourages “use of plans, strategies, and practices that consider the social determinants that may contribute to poor health outcomes.” (CMS, Quality Innovation Network Quality Improvement Organization Scope of Work: Excellence in Operations and Quality Improvement, 2014).
Similarly, MIPS and APMs RFI comments supported the inclusion of the subcategory of “Integrated Behavioral and Mental Health,” citing that “statistics show 50 percent of all behavioral health disorders are being treated by primary care and behavioral health integration.” Additionally, according to MIPS and APMs RFI comments, behavioral health integration with primary care is already being implemented in numerous locations throughout the country. The third additional subcategory we proposed to include is “Emergency Preparedness and Response,” based on MIPS and APMs RFI comments that encouraged us to consider this subcategory to help ensure that practices remain open during disaster and emergency situations and support emergency response teams as needed. Additionally, commenters were able to provide a sufficient number of recommended activities (that is, more than one) that could be included in the improvement activities inventory in all of these proposed subcategories and the subcategories included under section 1848(q)(2)(B)(iii) of the Act.
We also solicited public comments on two additional subcategories for future consideration:
• Promoting Health Equity and Continuity, including (a) serving Medicaid beneficiaries, including individuals dually eligible for Medicaid and Medicare, (b) accepting new Medicaid beneficiaries, (c) participating in the network of plans in the Federally Facilitated Marketplace or state exchanges, and (d) maintaining adequate equipment and other accommodations (for example, wheelchair access, accessible exam tables, lifts, scales, etc.) to provide comprehensive care for patients with disabilities; and
• Social and Community Involvement, such as measuring completed referrals to community and social services or evidence of partnerships and collaboration with community and social services.
For these two subcategories, we requested activities that can demonstrate some improvement over time and go beyond current practice expectations. For example, maintaining existing medical equipment would not qualify for an improvement activity, but implementing some improved clinical workflow processes that reduce wait times for patients with disabilities or improve coordination of care including activities that regularly provide additional assistance to find other care needed for patients with disabilities, would be some examples of activities that could show improvement in clinical practice over time.
We requested comments on these proposals.
The following is summary of the comments we received regarding improvement activities subcategories.
One commenter recommended that for this subcategory, CMS require both MIPS eligible clinicians and community service clinicians to demonstrate improvement in their respective functions, processes, or outcomes and consider developing metrics to evaluate the quality of health and well-being services that community-based organizations provide. Another commenter recommended that activities in the Social and Community Involvement subcategory include employing community health workers (CHWs) or integrating CHWs employed by community-based organizations into care teams, establishing a community advisory council, and creating formal linkages with social services clinicians and community-based organizations.
After consideration of the comments regarding improvement activities subcategories we are finalizing at § 414.1365 that the improvement activities performance category will include the subcategories of activities provided at section 1848(q)(2)(B)(iii) of the Act. In addition, we are finalizing at § 414.1365 the following additional subcategories: “Achieving Health Equity,” “Integrated Behavioral and Mental Health,” and “Emergency Preparedness and Response.”
To implement the MIPS program, we are required to create an inventory of improvement activities. Consistent with our MIPS strategic goals, we believe it is important to create a broad list of activities that can be used by multiple practice types to demonstrate improvement activities and activities that may lend themselves to being measured for improvement in future years.
We took several steps to ensure the initial improvement activities inventory is inclusive of activities in line with the statutory language. We had numerous interviews with highly performing organizations of all sizes, conducted an environmental scan to identify existing models, activities, or measures that met all or part of the improvement activities performance category, including the patient-centered medical homes, the Transforming Clinical Practice Initiative (TCPI), CAHPS surveys, and AHRQ's Patient Safety Organizations. In addition, we reviewed the CY 2016 PFS final rule with comment period (80 FR 70886) and the comments received in response to the MIPS and APMs RFI regarding the improvement activiies performance category. The improvement activities inventory was compiled as a result of the stakeholder input, an environmental scan, MIPS and APMs RFI comments, and subsequent working sessions with AHRQ and ONC and additional communications with CDC, SAMHSA and HRSA.
Based on the above discussions we established guidelines for improvement activities inclusion based on one or more of the following criteria (in any order):
• Relevance to an existing improvement activities subcategory (or a proposed new subcategory);
• Importance of an activity toward achieving improved beneficiary health outcome;
• Importance of an activity that could lead to improvement in practice to reduce health care disparities;
• Aligned with patient-centered medical homes;
• Representative of activities that multiple MIPS eligible clinicians or groups could perform (for example, primary care, specialty care);
• Feasible to implement, recognizing importance in minimizing burden, especially for small practices, practices in rural areas, or in areas designated as geographic HPSAs by HRSA;
• CMS is able to validate the activity; or
• Evidence supports that an activity has a high probability of contributing to improved beneficiary health outcomes.
Activities that overlap with other performance categories were included if there was a strong policy rationale to include it in the improvement activities inventory. We proposed to use the improvement activities inventory for the transition year of MIPS, as provided in Table H in in the Appendix to this final rule with comment period. For further description of how MIPS eligible clinicians or groups would be designated to submit to MIPS for improvement activities, we refer readers to the proposed rule (81 FR 28177). For all other MIPS eligible clinicians or groups participating in APMs that would report to MIPS, this section applies and we also refer readers to the scoring requirements for these MIPS eligible clinicians or groups in the proposed rule (81 FR 28234).
We requested comments on the improvement activities inventory and suggestions for improvement activities for future years as well.
The following is a summary of the comments we received regarding the statutory requirements for improvement activities related to the activities that must be specified under the improvement activities performance category. We refer readers to Table H in in the Appendix to this final rule with comment period.
We note that because anticoagulants have been consistently identified as the most common causes of adverse drug events across health care settings, the Population Management activity starting with “Participation in a systematic anticoagulation program (coagulation clinic, patient self-reporting program, patient self-management program highlights)” highlights the importance of close monitoring of Vitamin K antagonist therapy (warfarin) and the use of other coagulation cascade inhibitors.
After consideration of the comments regarding the improvement activities inventory, we are finalizing the improvement activities and weighting provided in Table H in the Appendix to this final rule with comment period as proposed with the exception of the following: One change for one activity in the Emergency Response and Preparedness Subcategory from a medium to a high-weighted activity; one change for one activity in the Population Management Subcategory from a medium to a high-weighted activity; we have included the addition of an asterisk (*) in Table H in the Appendix to this final rule with comment period, next to activities that also qualify for the advancing care information bonus, and refer readers to section II.E.6.a.(5) of this final rule with comment period. We also included language, elaborating on the requirements for the Consultation PDMP activity. We are correcting the reference to Million Hearts Cardiovascular Risk Reduction Model instead of describing it as a “campaign;” and revising the wording of the proposed activity “Use decision support and protocols to manage workflow in the team to meet patient needs” to read “Use decision support and standardized treatment protocols to manage workflow in the team to meet patient needs;” and “removing the State Innovation Model participation activity.” Our reasoning for these changes is to alleviated confusion related to the activity based on comments, to correct a previous incorrect term such as the use of the word “campaign” or as a result of some other change in another section of the final rule with comment period, specifically inclusion of qualifying improvement activities for the advancing care information bonus. Our reasoning for changing the CAHPS for MIPS survey weighting to high is because the CAHPS for MIPS survey will be optional for large groups under the quality performance category and we want to encourage use of this survey. Another contributing element was the need to ensure options beyond the CAHPS for MIPS survey were available to provide credit for surveying and for CAHPS that did not meet thresholds/standards for reporting in measure category (largely because they did not have enough beneficiaries). Our reasoning for removing the State Innovation Model (SIM) activity is that SIM is a series of a different agreements between CMS and states. Clinicians are not direct participants. In addition, we do not collect TIN/NPI combinations, so there is no way to validate participation based on attestation. Our reasoning for changing the weighting on the Emergency Response and Preparedness activity is that this improvement activity requires the clinician pay out of pocket to travel and do volunteer work (personal costs/risks), likely contributing some donated medical durables/expendables (practice material resources). In addition, the clinician also misses scheduled appointments with patients (foregoing practice financial revenue). Our reasoning for changing the weighting on the Population Management activity is that this improvement activity is consistent with section 1848(q)(2)(B)(iii) of the Act, which requires the Secretary to give consideration to the circumstances of practices located in rural areas and geographic HPSAs. Rural health clinics would be included in that definition for consideration of practices in rural areas. All of these changes are reflected in Table H in the Appendix to this final rule with comment period.
Previous experience with the PQRS, VM, and Medicare EHR Incentive programs have shown that many clinicians have errors within their data sets, as well as problems in understanding and choosing the data that corresponds to their selected quality measures. In CMS' quest to create a culture of improvement using evidence based medicine on a consistent basis, fully understanding the strengths and limitations of the current processes is crucial to better understand the current processes, we proposed to conduct a study on clinical improvement activities and measurement to examine clinical quality workflows and data capture using a simpler approach to quality measures.
The lessons learned in this study on practice improvement and measurement may influence changes to future MIPS data submission requirements. The goals of the study are to see whether there will be improved outcomes, reduced burden in reporting, and enhancements in clinical care by selected MIPS eligible clinicians desiring:
• A more data driven approach to quality measurement.
• Measure selection unconstrained by a CEHRT program or system.
• Improving data quality submitted to CMS.
• Enabling CMS get data more frequently and provide feedback more often.
This present study will select 10 non-rural individual MIPS eligible clinicians or groups of less than three non-rural MIPS eligible clinicians, 10 rural individual MIPS eligible clinicians or groups of less than three rural MIPS eligible clinician's, 10 groups of three to eight MIPS eligible clinicians, five groups of nine to 20 MIPS eligible clinicians, three groups of 21 to 100 MIPS eligible clinicians, two groups of greater than 100 MIPS eligible clinicians, and two specialist groups of MIPS eligible clinicians. Participation would be open to a limited number of MIPS eligible clinicians in rural settings and non-rural settings. A rural area is defined at § 414.1305 and a non-rural area would be any MIPS eligible clinicians or groups not included as part of the rural definition. MIPS eligible clinicians and groups would need to sign up from January 1, 2017, to January 31, 2017. The sign up process will utilize a web-based interface. Participants would be approved on a first come first served basis and must meet all the required criteria. Selection criteria will also be based on different states and also within different clinician settings that falls in the participation eligibility criteria.
MIPS eligible clinicians and groups in the CMS study on practice improvement and measurement will receive full credit (40 points) for the improvement activities performance category of MIPS after successfully electing, participating and submitting data to the study coordinators at CMS for the full calendar year.
Based on feedback and surveys from MIPS eligible clinicians, study measurement data will be collected at baseline and at every three months (quarterly basis) afterwards for the duration of the calendar year. Study participants who can submit data on a more frequent basis will be encouraged to do so.
Participants will be required to attend a monthly focus group to share lessons learned along with providing survey feedback to monitor effectiveness. The focus group would also include providing visual displays of data, workflows, and best practices to be shared amongst the participants to obtain feedback and make further improvements. The monthly focus groups would be used to learn from the practices on how to be more agile as we test new ways of measure recording and workflow.
For CY 2017, the participating MIPS eligible clinicians or groups would submit their data and workflows for a minimum of three MIPS CQMs that are relevant and prioritized by their practice. One of the measures must be an outcome measure, and one must be a patient experience measure. The participating MIPS eligible clinicians could elect to report on more measures as this would provide more options from which to select in subsequent years for purposes of measuring improvement.
If MIPS eligible clinicians or groups calculate the measures working with a QCDR, qualified registry, or CMS-approved third party intermediary, we would use the same data validation process described in the proposed rule (81 FR 28279). We would only collect the numerator and denominator for the measures selected for the overall population, all patients/all payers. This would enable the practices to build the measures based on what is important for their area of practice while increasing the quality of care.
The first round of the study will last for 1 year after which new participants will be recruited. Participants electing to continue in future years would be afforded the opportunity to opt-in or opt-out following the successful submission of data to us. The first opportunity to continue in the study would be at the end of the 2017 performance period. Eligible clinicians who elect to join the study but fail to participate in the study requirements and/or fail to successfully submit the data required will be removed from the study. Unsuccessful study participants will then be subject to the full requirements for the improvement activities performance category.
In future years, participating MIPS eligible clinicians or groups would select three of the measures for which they have baseline data from the 2017 performance period to compare against later performance years.
We requested comment on the study and welcome suggestions on future study topics.
The following is a summary of the comments we received regarding the CMS study on improvement activities and measurement.
After consideration of the comments regarding the CMS study on improvement activities and measurement we are finalizing the policies with the exception that successful participation in the pilot would result in full credit for the improvement activities performance category of 40 points, not 60 points, in accordance with the revised finalized scoring. If participants do not meet the study guidelines they will be removed from the study and need to follow the current improvement activities guidelines.
We proposed, for future years of MIPS, to consider the addition of a new subcategory to the improvement activities performance category only when the following criteria are met:
• The new subcategory represents an area that could highlight improved beneficiary health outcomes, patient engagement and safety based on evidence.
• The new subcategory has a designated number of activities that meet the criteria for an improvement activity and cannot be classified under the existing subcategories.
• Newly identified subcategories would contribute to improvement in patient care practices or improvement in performance on quality measures and cost performance categories.
In future years, MIPS eligible clinicians or groups would have an opportunity to nominate additional subcategories, along with activities associated with each of those subcategories that are based on criteria specified for these activities, as discussed in the proposed rule. We requested comments on this proposal.
We did not receive any comments regarding policies for identifying new improvement activities subcategories in future years of the MIPS program. We therefore are finalizing the addition of a new subcategory to the improvement activities performance category only when the following criteria are met:
• The new subcategory represents an area that could highlight improved beneficiary health outcomes, patient engagement and safety based on evidence.
• The new subcategory has a designated number of activities that meet the criteria for an improvement activity and cannot be classified under the existing subcategories.
• Newly identified subcategories would contribute to improvement in patient care practices or improvement in performance on quality measures and cost performance categories.
We plan to develop a call for activities process for future years of MIPS, where MIPS eligible clinicians or groups and other relevant stakeholders may recommend activities for potential inclusion in the improvement activities inventory. As part of the process, MIPS eligible clinicians or groups would be able to nominate additional activities that we could consider adding to the improvement activities inventory. The MIPS eligible clinician or group or relevant stakeholder would be able to provide an explanation of how the activity meets all the criteria we have identified. This nomination and acceptance process would, to the best extent possible, parallel the annual call for measures process already conducted by CMS for quality measures. The final improvement activities inventory for the performance year would be published in accordance with the overall MIPS rulemaking timeline. In addition, in future years we anticipate developing a process and establishing criteria to remove or add new activities to improvement activities performance category.
Additionally, prospective activities that are submitted through a QCDR could also be included as part of a beta-test process that may be instrumental for future years to determine whether that activity should be included in the improvement activities inventory based on specific criteria noted above. MIPS eligible clinicians or groups that use QCDRs to capture data associated with an activity, for example the frequency in administering depression screening and a follow-up plan, may be requested to voluntarily submit that same data in year 2 to begin identifying a baseline for improvement for subsequent year analysis. This is not intended to require any MIPS eligible clinician or group to submit improvement activities only via QCDR from 1 year to the next or to require the same activity from 1 year to the next. Participation in doing so, however, can help to identify how activities can contribute to improve outcomes. This data submission process will be considered part of a beta-test to: (1) Determine if the activity is being regularly conducted and effectively executed and (2) if the activity warrants continued inclusion on the improvement activities inventory. The data would help capture baseline information to begin measuring improvement and inform the Secretary of the likelihood that the activity would result in improved outcomes. If an activity is submitted and reported by a QCDR, it would be reviewed by us for final inclusion in the improvement activities inventory the following year, even if these activities are not submitted through the future call for measures and activities process. We intend, in future performance years, to begin measuring improvement activities data points for all MIPS eligible clinicians and to award scores based on performance and improvement. We solicited comment on how best to collect such improvement activities data and factor it into future scoring under MIPS.
We requested comments on these approaches and on any other considerations we should take into account when developing these type of approaches for future rulemaking.
The following is summary of the comments we received regarding improvement activities policies for identifying new improvement activities in future years of the MIPS program.
Other commenters recommended that CMS allow MIPS eligible clinicians to maintain improvement activities over time and opposed CMS proposals to have more stringent requirements. These commenters were concerned that by imposing limits on frequency of reporting of the same activity over several years, CMS would be encouraging practices to implement temporary instead of permanent improvements and would risk creating short-lived activities that lack consistency across time, which is not beneficial to patients and is confusing and disruptive to MIPS eligible clinicians' workflow.
A few commenters recommended that CMS permit MIPS eligible clinicians to select from a wide range of improvement activities, allow MIPS eligible clinicians to perform them in a way that is effective and reasonable for both the MIPS eligible clinicians and their patient population, and refrain from imposing restrictive specifications
We intend to monitor MIPS eligible clinicians' participation in improvement activities carefully, and as the commenters suggested, we will continue examining potential relationships to quality measurement, advancing care information measures leveraging CEHRT, and APM participation readiness. We intend to continue collaborating with specialty clinicians, medical societies, and other stakeholders when conducting these evaluations.
We will take the comments regarding improvement activities policies for identifying new improvement activities in future years of the MIPS program into consideration for future rulemaking.
In future years, we expect to learn more about improvement activities and how the inclusion of additional measures and activities captured by QCDRs could enhance the ability of MIPS eligible clinicians or groups to capture and report on more meaningful activities. This is especially true for specialty groups. In the future, we may propose use of QCDRs for identification and acceptance of additional measures and activities which is in alignment with section 1848(q)(1)(E) of the Act which encourages the use of QCDRs, as well as under section 1848(q)(2)(B)(iii)(II) of the Act related to the population management subcategory. We recognize, through the MIPS and APMs RFI comments and interviews with organizations that represent non-patient facing MIPS eligible clinicians or groups and specialty groups that QCDRs may provide for a more diverse set of measures and activities under improvement activities than are possible to list under the current improvement activities inventory. This diverse set of measures and activities, which we can validate, affords specialty practices additional opportunity to report on more meaningful activities in future years. QCDRs may also provide the opportunity for longer-term data collection processes which will be needed for future year submission on improvement, in addition to achievement. Use of QCDRs also supports ongoing performance feedback and allows for implementation of continuous process improvements. We believe that for future years, QCDRs would be allowed to define specific improvement activities for specialty and non-patient facing MIPS eligible clinicians or groups through the already-established QCDR approval process for measures and activities. We requested comments on this approach. We did not receive any comments regarding the use of QCDRs for identification and tracking of future activities.
The use of health IT is an important aspect of care delivery processes described in many improvement activities. In this final rule with comment period we have finalized a policy to allow MIPS eligible clinicians to achieve a bonus in the advancing care information performance category when they use functions included in CEHRT to complete eligible activities from the improvement activities inventory. Please refer to section II.E.5.g. of this final rule with comment period for details on how improvement activities using CEHRT relate to the objectives and measures of the advancing care information and improvement activities performance categories.
In addition to those functions included under the CEHRT definition, ONC certifies technology for additional emerging health IT capabilities which may also be important for enabling activities included in the improvement activities inventory, such as technology certified to capture social, psychological, and behavioral data according to the criterion at 80 FR 62631, and technology certified to generate and exchange an electronic care plan (as described at 80 FR 62648). In the future, we may consider including these emerging certified health IT capabilities as part of activities within the improvement activities inventory. By referencing these certified health IT capabilities in improvement activities, clinicians would be able to earn credit under the improvement activities performance category while gaining experience with certification criteria that may be reflected as part of the CEHRT definition at a later time. Moreover, health IT developers will be able to innovate around these relevant standards and certification criteria to better serve clinicians' needs.
We invite comments on this approach to encourage continued innovation in health IT to support improvement activities.
The American Recovery and Reinvestment Act of 2009 (ARRA), which included the Health Information Technology for Economic and Clinical Health Act (HITECH Act), amended Titles XVIII and XIX of the Act to authorize incentive payments and Medicare payment adjustments for EPs to promote the adoption and meaningful use of CEHRT. Section 1848(o) of the Act provides the statutory basis for the Medicare incentive payments made to meaningful EHR users. Section 1848(a)(7) of the Act also establishes downward payment adjustments, beginning with CY 2015, for EPs who
A primary policy goal of the EHR Incentive Program is to encourage and promote the adoption and use of CEHRT among Medicare and Medicaid health care providers to help drive the industry as a whole toward the use of CEHRT. As described 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” (hereinafter referred to as the “2015 EHR Incentive Programs final rule”) (80 FR 62769), the HITECH Act outlined several foundational requirements for meaningful use and for EHR technology. CMS and ONC have subsequently outlined a number of key policy goals which are reflected in the current objectives and measures of the program and the related certification requirements (80 FR 62790). Current Medicare EP performance on these key goals is varied, with EPs demonstrating high performance on some objectives while others represent a greater challenge.
Section 1848(q)(2)(A) of the Act, as added by section 101(c) of the MACRA, includes the meaningful use of CEHRT as a performance category under the MIPS, referred to in the proposed rule and in this final rule with comment period as the advancing care information performance category, which will be reported by MIPS eligible clinicians as part of the overall MIPS program. As required by sections 1848(q)(2) and (5) of the Act, the four performance categories shall be used in determining the MIPS final score for each MIPS eligible clinician. In general, MIPS eligible clinicians will be evaluated under all four of the MIPS performance categories, including the advancing care information performance category. This includes MIPS eligible clinicians who were not previously eligible for the EHR Incentive Program incentive payments under section 1848(o) of the Act or subject to the EHR Incentive Program payment adjustments under section 1848(a)(7) of the Act, such as physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and hospital-based EPs (as defined in section 1848(o)(1)(C)(ii) of the Act). Understanding that these MIPS eligible clinicians may not have prior experience with CEHRT and the objectives and measures under the EHR Incentive Program, we proposed a scoring methodology within the advancing care information performance category that provides flexibility for MIPS eligible clinicians from early adoption of CEHRT through advanced use of health IT. In the proposed rule (81 FR 28230 through 28233), we also proposed to reweight the advancing care information performance category to zero in the MIPS final score for certain hospital-based and other MIPS eligible clinicians where the measures proposed for this performance category may not be available or applicable to these types of MIPS eligible clinicians.
In implementing MIPS, we intend to develop the requirements for the advancing care information performance category to continue supporting the foundational objectives of the HITECH Act, and to encourage continued progress on key uses such as health information exchange and patient engagement. These more challenging objectives are essential to leveraging CEHRT to improve care coordination and they represent the greatest potential for improvement and for significant impact on delivery system reform in the context of MIPS quality reporting.
In developing the requirements and structure for the advancing care information performance category, we considered several approaches for establishing a framework that would naturally integrate with the other MIPS performance categories. We considered historical performance on the EHR Incentive Program objectives and measures, feedback received through public comment, and the long term goals for delivery system reform and quality improvement strategies.
One approach we considered would be to maintain the current structure of the Medicare EHR Incentive Program and award full points for the advancing care information performance category for meeting all of the objectives and measures finalized in the 2015 EHR Incentive Programs final rule, and award zero points for failing to meet all of these requirements. This method would be consistent with the current EHR Incentive Program and is based on objectives and measures already established in rulemaking. However, we considered and dismissed this approach as it would not allow flexibility for MIPS eligible clinicians and would not allow us to effectively measure performance for MIPS eligible clinicians in the advancing care information performance category who have taken incremental steps toward the use of CEHRT, or to recognize exceptional performance for MIPS eligible clinicians who have excelled in any one area. This is particularly important as many MIPS eligible clinicians may not have had past experience relevant to the advancing care information performance category and use of EHR technology because they were not previously eligible to participate in the Medicare EHR Incentive Program. This approach also does not allow for differentiation among the objectives and measures that have high adoption and those where there is potential for continued advancement and growth.
We subsequently considered several methods which would allow for more flexibility and provide CMS the opportunity to recognize partial or exceptional performance among MIPS eligible clinicians for the measures under the advancing care information performance category. We decided to design a framework that would allow for flexibility and multiple paths to achievement under this category while recognizing MIPS eligible clinicians' efforts at all levels. Part of this framework requires moving away from the concept of requiring a single threshold for a measure, and instead incentivizes continuous improvement, and recognizes onboarding efforts among late adopters and MIPS eligible clinicians facing continued challenges in full implementation of CEHRT in their practice.
Below is a summary of the comments received on our overall approach to the advancing care information performance category under MIPS:
In defining the advancing care information performance category for the MIPS, we considered stakeholder feedback and lessons learned from our experience with the Medicare EHR Incentive Program. Specifically, we considered feedback from the Stage 1 (75 FR 44313) and Stage 2 (77 FR 53967) EHR Incentive Program rules, and the 2015 EHR Incentive Programs final rule (80 FR 62769), as well as comments received from the MIPS and APMs RFI (80 FR 59102). We have learned from this feedback that clinicians desire flexibility to focus on health IT implementation that is right for their practice. We have also learned that updating software, training staff and changing practice workflows to accommodate new technology can take time, and that clinicians need time and flexibility to focus on the health IT activities that are most relevant to their patient population. Clinicians also desire consistent timelines and reporting requirements to simplify and streamline the reporting process. Recognizing this, we have worked to align the advancing care information performance category with the other MIPS performance categories, which would streamline reporting requirements, timelines and measures in an effort to reduce burden on MIPS eligible clinicians.
The implementation of the advancing care information performance category is an important opportunity to increase clinician and patient engagement, improve the use of health IT to achieve better patient outcomes, and continue to meet the vision of enhancing the use of CEHRT as defined under the HITECH Act. In the proposed rule (81 FR 28220), we proposed substantial flexibility in how we would assess MIPS eligible clinician performance for the new advancing care information performance category. We proposed to emphasize performance in the objectives and measures that are the most critical and would lead to the most improvement in the use of health IT to advance health care quality. We intend to promote innovation so that technology can be interconnected easily and securely, and data can be accessed and directed where and when it is needed to support patient care. These objectives include Patient Electronic Access, Coordination of Care Through Patient Engagement and Health Information Exchange, which are essential to leveraging CEHRT to improve care. At the same time, we proposed to eliminate reporting on objectives and measures in which the vast majority of clinicians already achieve high performance—which would reduce burden, encourage greater participation and direct MIPS eligible clinicians' attention to higher-impact measures. Our proposal balances program participation with rewarding performance on high-impact objectives and measures, which we believe would make the overall program stronger and further the goals of the HITECH Act.
Section 1848(o)(2)(A) of the Act requires that the Secretary seek to improve the use of EHRs and health care quality over time by requiring more stringent measures of meaningful use. In implementing MIPS and the advancing care information performance category, we sought to improve and encourage the use of CEHRT over time by adopting a new, more flexible scoring methodology, as discussed in the proposed rule (81 FR 28220) that would more effectively allow MIPS eligible clinicians to reach the goals of the HITECH Act, and would allow MIPS eligible clinicians to use EHR technology in a manner more relevant to their practice. This new, more flexible scoring methodology puts a greater focus on Patient Electronic Access, Coordination of Care Through Patient Engagement, and Health Information Exchange—objectives we believe are essential to leveraging CEHRT to improve care by engaging patients and furthering interoperability. This methodology would also de-emphasize objectives in which clinicians have historically achieved high performance with median performance rates of over 90 percent for the last 2 years. We believe shifting focus away from these objectives would reduce burden, encourage greater participation, and direct attention to other objectives and measures which have significant room for continued improvement. Through this flexibility, MIPS eligible clinicians would be incentivized to focus on those aspects of CEHRT that are most relevant to their practice, which we believe would lead to improvements in health care quality.
We also sought to increase the adoption and use of CEHRT by incorporating such technology into the other MIPS performance categories. For example, in section II.E.6.a.(2)(f) of the proposed rule (81 FR 28247), we proposed to incentivize electronic reporting by awarding a bonus point for submitting quality measure data using CEHRT. Additionally, in section II.E.5.f. of the proposed rule (81 FR 28209), we aligned some of the activities under the improvement activities performance category such as Care Coordination, Beneficiary Engagement and Achieving Health Equity with a focus on enhancing the use of CEHRT. We believe this approach would strengthen the adoption and use of certified EHR systems and program participation consistent with the provisions of section 1848(o)(2)(A) of the Act.
Below is a summary of the comments received regarding our overall approach to requirements under the advancing care information performance category:
We hope to continue to work with our stakeholders over the coming years so that we can continue to improve the framework and implementation of this performance category in order to improve health outcomes for patients across the country.
The restructuring of program requirements described in this final rule with comment period are geared toward increasing participation and EHR adoption. We believe this is the most effective way to encourage the adoption of CEHRT, and introduce new MIPS eligible clinicians to the use of certified EHR technology and health IT overall.
We will continue to review and evaluate MIPS eligible clinician performance in the advancing care information performance category, and will consider evolutions in health IT over time as it relates to this performance category. Based on our ongoing evaluation, we expect to adopt changes to the scoring methodology for the advancing care information performance category to ensure the efficacy of the program and to ensure increased value for MIPS eligible clinicians and the Medicare Program, as well as to adopt more stringent measures of meaningful use as required by section 1848(o)(2)(A) of the Act.
Potential changes may include establishing benchmarks for MIPS eligible clinician performance on the advancing care information performance category measures, and using these benchmarks as a baseline or threshold for future reporting. This may include scoring for performance improvement over time and the potential to reevaluate the efficacy of measures based on these analyses. For example, in future years we may use a MIPS eligible clinician's prior performance on the advancing care information performance category measures as comparison for the subsequent year's performance category score, or compare a MIPS eligible clinician's performance category score to peer groups to measure their improvement and determine a performance category score based on improvement over those benchmarks or peer group comparisons. This type of approach would drive continuous improvement over time through the adoption of more stringent performance standards for the advancing care information performance category measures.
We are committed to continual review, improvement and increased stringency of the advancing care information performance category measures as directed under section 1848(o)(2)(A) of the Act both for the purposes of ensuring program efficacy, as well as ensuring value for the MIPS eligible clinicians reporting the advancing care information performance category measures. We solicited comment on further methods to increase the stringency of the advancing care information performance category measures in the future.
We additionally solicited comment on the concept of a holistic approach to health IT—one that we believe is similar to the concept of outcome measures in the quality performance category in the sense that MIPS eligible clinicians could potentially be measured more directly on how the use of health IT contributes to the overall health of their patients. Under this concept, MIPS eligible clinicians would be able to track certain use cases or patient outcomes to tie patient health outcomes with the use of health IT.
We believe this approach would allow us to directly link health IT adoption and use to patient outcomes, moving MIPS beyond the measurement of EHR adoption and process measurement and into a more patient-focused health IT program. From comments and feedback we have received from the health care provider community, we understand that this type of approach would be a welcome enhancement to the measurement of health IT. At this time, we recognize that technology and measurement for this type of program is currently unavailable. We solicited comment on what this type of measurement would look like under MIPS, including the type of measures that would be needed within the advancing care information performance category and the other performance categories to measure this type of outcome, what functionalities with CEHRT would be needed, and how such an approach could be implemented.
The following is a summary of the comments we received:
In Table 8, we identify a set of improvement activities from the improvement activities performance category that can be tied to the objectives, measures, and CEHRT functions of the advancing care information performance category and would thus qualify for the bonus in the advancing care information performance category. For further explanation of these improvement activities, we refer readers to the discussion in section II.E.5.f. of this final rule with comment period. While we note that these activities can be greatly enhanced through the use of CEHRT, we are not suggesting that these activities require the use of CEHRT for the purposes of
After consideration of the comments, we will award a 10 percent bonus in the advancing care information performance category if a MIPS eligible clinician attests to completing at least one of the improvement activities specified in Table 8 using CEHRT. We note that 10 percent is the maximum bonus a MIPS eligible clinician will receive whether they attest to using CEHRT for one or more of the activities listed in the table. This bonus is intended to support progression toward holistic health IT use and measurement; attesting to even one improvement activity demonstrates that the MIPS eligible clinician is working toward this holistic approach to the use of their CEHRT. We additionally note that the weight of the improvement activity has no bearing on the bonus awarded in the advancing care information performance category.
We are seeking comment on this integration of the improvement activities with the advancing care information performance category, and other ways to further the advancement of health IT measurement.
Section 1848(o)(2)(A)(iii) of the Act requires the reporting of CQMs using CEHRT. Section 1848(q)(5)(B)(ii)(II) of the Act provides that under the methodology for assessing the total performance of each MIPS eligible clinician, the Secretary shall, for a performance period for a year, for which a MIPS eligible clinician reports applicable measures under the quality performance category through the use of CEHRT, treat the MIPS eligible clinician as satisfying the CQM reporting requirement under section 1848(o)(2)(A)(iii) of the Act for such year. We note that in the context and overall structure of MIPS, the quality performance category allows for a greater focus on patient-centered measurement, and multiple pathways for MIPS eligible clinicians to report their quality measure data. Therefore, we did not propose separate requirements for CQM reporting within the advancing care information performance category and instead would require submission of quality data for measures specified for the quality performance category, in which we encourage reporting of CQMs with data captured in CEHRT. We refer readers to section II.E.5.a.of the proposed rule (81 FR 28184-28196) for discussion of reporting of CQMs with data captured in CEHRT under the quality performance category.
Below is a summary of the comments received regarding CQM reporting for the advancing care information category:
In the Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Stage 3 proposed rule, we proposed to eliminate the 90-day EHR reporting period beginning in 2017 for EPs who had not previously demonstrated meaningful use, with a limited exception for the Medicaid EHR Incentive Program (80 FR 16739-16740, 16774-16775). We received many comments from respondents stating their preference for maintaining the 90-day EHR reporting period to allow first time participants to avoid payment adjustments. In addition, commenters indicated that the 90-day time period reduced administrative burden and allowed for needed time to adapt their EHRs to ensure they could achieve program objectives. As a result, we did not finalize our proposal and established a 90-day EHR reporting period for all EPs in 2015 and for new participants in 2016, as well as a 90-day EHR reporting period for new participants in 2015, 2016, and 2017 with regard to the payment adjustments (80 FR 62777-62779; 62904-62906). In addition we have proposed a 90-day EHR reporting period in 2016 for the EHR Incentive Programs in a recent proposed rule, the Calendar Year (CY) 2017 Changes to the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) (81 FR 45753).
Moving forward, the implementation of MIPS creates a critical opportunity to align performance periods to ensure that quality, improvement activities, cost, and the advancing care information performance categories are all measured and scored based on the same period of time. We believe this would lower reporting burden, focus clinician quality improvement efforts and align administrative actions so that MIPS eligible clinicians can use common systems and reporting pathways.
Under MIPS, we proposed to align the performance period for the advancing care information performance category to the proposed MIPS performance period of one full calendar year and the intent of the proposal was to reduce reporting burden and streamline requirements so that MIPS eligible clinicians and third party intermediaries, such as registries and QCDRs, would have a common timeline for data submission to all performance categories (81 FR 28179-28181). Therefore, we noted there would not be a separate 90-day performance period for the advancing care information performance category and MIPS eligible clinicians would need to submit data based on performance period starting January 1, 2017, and ending December 31, 2017 for the first year of MIPS. We also stated that MIPS eligible clinicians that only have data for a portion of the year can still submit data, be assessed and be scored for the advancing care information performance category (81 FR 28179-28181). Under that proposal, MIPS eligible clinicians would need to possess CEHRT and report on the objectives and measures (without meeting any thresholds) during the calendar year performance period to achieve the advancing care information performance category base score. Finally, we stated that MIPS eligible clinicians would be required to submit all of the data they have available for the performance period, even if the time period they have data for is less than one full calendar year.
The following is a summary of the comments we received regarding our advancing care information performance period proposal.
Other commenters noted that MIPS eligible clinicians must perform improvement activities for the improvement activities performance category for at least a 90-day performance period, and suggested adopting the same for the advancing care information performance category as it would create alignment. Some commenters requested a performance period of 90-days for the first several years of the program. A few recommended a 90-day performance period every time a new edition of
Additionally, we understand the commenters' concerns and rationale for requesting a 90-day performance period. As discussed in section II.E.4. of this final rule with comment period, for the first performance period of CY 2017, we will accept a minimum of 90 days of data within CY 2017, although we greatly encourage MIPS eligible clinicians to submit data for the full year performance period. Also in recognition of the switch from CEHRT certified to the 2014 Edition to CEHRT certified to the 2015 Edition, for the 2018 performance period we will also accept a minimum of 90 days of data within CY 2018. We refer readers to section II.E.4. of this final rule with comment period for further discussion about the MIPS performance period and the 90-day minimum.
After consideration of the public comments received, we are finalizing our proposal to align the performance period for the advancing care information performance category with the MIPS performance period of one full calendar year. For the first performance period of MIPS (CY 2017), we will accept a minimum of 90 consecutive days of data in CY 2017, however, we encourage MIPS eligible clinicians to report data for the full year performance period. For the second performance period of MIPS (CY 2018), we will accept a minimum of 90 consecutive days of data in 2018, however, we encourage MIPS eligible clinicians to report data for the full year performance period. We refer readers to section II.E.4. of this final rule with comment period for further discussion of the MIPS performance period.
In the 2015 EHR Incentive Programs final rule (80 FR 62873), we outlined the requirements for EPs using CEHRT in 2017 for the Medicare and Medicaid EHR Incentive Programs as it relates to the objectives and measures they select to report. In the proposed rule, we proposed to adopt a definition of CEHRT at § 414.1305 for MIPS eligible clinicians that is based on the definition that applies in the EHR Incentive Programs under § 495.4.
We proposed for 2017, the first MIPS performance period, MIPS eligible clinicians would be able to use EHR technology certified to either the 2014 or 2015 Edition certification criteria as follows:
• A MIPS eligible clinician who only has technology certified to the 2015 Edition may choose to report: (1) On the objectives and measures specified for the advancing care information performance category in section II.E.5.g.(7) of the proposed rule (81 FR 28221 through 28223), which correlate to Stage 3 requirements; or (2) on the alternate objectives and measures specified for the advancing care information performance category in section II.E.5.g.(7) of the proposed rule (81 FR 28223 and 28224), which correlate to modified Stage 2 requirements.
• A MIPS eligible clinician who has technology certified to a combination of 2015 Edition and 2014 Edition may choose to report: (1) On the objectives and measures specified for the advancing care information performance category in section II.E.5.g.(7) of the proposed rule (81 FR 28221 through 28223), which correlate to Stage 3; or (2) on the alternate objectives and measures specified for the advancing care information performance category as described in section II.E.5.g.(7) of the proposed rule (81 FR 28223 and 28224), which correlate to modified Stage 2, if they have the appropriate mix of technologies to support each measure selected.
• A MIPS eligible clinician who only has technology certified to the 2014 Edition would not be able to report on any of the measures specified for the advancing care information performance category described in section II.E.5.g.(7) of the proposed rule (81 FR 28221 through 28223) that correlate to a Stage 3 measure that requires the support of technology certified to the 2015 Edition. These MIPS eligible clinicians would be
We proposed beginning with the performance period in 2018, MIPS eligible clinicians:
• Must only use technology certified to the 2015 Edition to meet the objectives and measures specified for the advancing care information performance category in section II.E.5.g.(7) of the proposed rule (81 FR 28222 and 28223), which correlate to Stage 3.
We welcomed comments on the proposals, which were intended to maintain consistency across MIPS, the Medicare EHR Incentive Program and the Medicaid EHR Incentive Program.
Finally, we proposed to define at § 414.1305 a meaningful EHR user under MIPS as a MIPS eligible clinician who possesses CEHRT, uses the functionality of CEHRT, and reports on applicable objectives and measures specified for the advancing care information performance category for a performance period in the form and manner specified by CMS.
The following is a summary of the comments we received regarding our proposal for EHR certification requirements.
After consideration of the comments we received, we are finalizing our proposal regarding EHR certification requirements at § 414.1305 as proposed and encourage MIPS eligible clinicians to prepare for the migration to the 2015 Edition of CEHRT in 2018. In 2017, MIPS eligible clinicians may use EHR technology certified to the 2014 Edition or the 2015 Edition or a combination of the two. We note that a MIPS eligible clinician who only has technology certified to the 2014 Edition would not be able to report certain measures specified for the advancing care information performance category that correlate to a Stage 3 measure for which there was no Stage 2 equivalent. These MIPS eligible clinicians may instead report the objectives and measures specified for the advancing care information performance category which correlate to Modified Stage 2 objectives and measures. In 2018, MIPS eligible clinicians must use EHR technology certified to the 2015 Edition.
The following is a summary of the comments we received regarding our proposal for defining a meaningful EHR user under MIPS.
After consideration of the public comments we received, we are finalizing our proposal to define a meaningful EHR user for MIPS under § 414.1305 as a MIPS eligible clinician who possesses CEHRT, uses the functionality of CEHRT, and reports on applicable objectives and measures specified for the advancing care information performance category for a performance period in the form and manner specified by CMS.
Under the Medicare EHR Incentive Program, EPs attest to the numerators and denominators for certain objectives and measures, through a CMS Web site. For the purpose of reporting advancing care information performance category objectives and measures under the MIPS, we proposed at § 414.1325 to allow for MIPS eligible clinicians to submit advancing care information performance category data through qualified registry, EHR, QCDR, attestation and CMS Web Interface submission methods. Regardless of data submission method, all MIPS eligible clinicians must follow the reporting requirements for the objectives and measures to meet the requirements of the advancing care information performance category.
We note that under this proposal, 2017 would be the first year that EHRs (through the QRDA submission
The following is a summary of the comments we received regarding our proposal to allow for multiple methods for data submission for the advancing care information performance category.
We note that there were several other comments related to data submission for MIPS, and we direct readers to section II.E.5.a. of this final rule with comment period for discussion of those comments. After consideration of the comments we received, we are finalizing our policy as proposed.
Under the Medicare EHR Incentive Program, we adopted a reporting mechanism for EPs that are part of a group, to attest using one common form, or a batch reporting process. To determine whether those EPs meaningfully used CEHRT, under that batch reporting process, we assessed the individual performance of the EPs that made up the group, not the group as a whole.
The structure of the MIPS and our desire to achieve alignment across the MIPS performance categories appropriately necessitates the ability to assess the performance of MIPS eligible
Under this option, we proposed that performance on advancing care information performance category objectives and measures would be assessed and reported at the group level, as opposed to the individual MIPS eligible clinician level. We note that the data submission criteria would be the same when submitted at the group-level as if submitted at the individual-level, but the data submitted would be aggregated for all MIPS eligible clinicians within the group practice. We believe this approach to data submission better reflects the team dynamics of the group, and would reduce the overall reporting burden for MIPS eligible clinicians that practice in groups, incentivize practice-wide approaches to data submission, and provide enterprise-level continuous improvements strategies for submitting data to the advancing care information performance category. Please see section II.E.1.e. of the proposed rule (81 FR 28178 and 28179) for more discussion of how to participate as a group under MIPS.
The following is a summary of the comments we received regarding our proposal to allow for group reporting starting in 2017.
As with group reporting for the other MIPS performance categories, to report as a group, the group will need to aggregate data for all the individual MIPS eligible clinicians within the group for whom they have data in CEHRT. For those who choose to report as a group, performance on the advancing care information performance category objectives and measures would be reported and evaluated at the group level, as opposed to the individual MIPS eligible clinician level. For example, the group calculation of the numerators and denominators for each measure must reflect all of the data from all individual MIPS eligible clinicians that have been captured in CEHRT for the given advancing care information measure. If the group practice has CEHRT that is capable of supporting group reporting, they would submit the aggregated data produced by the CEHRT. If the group practice does not have CEHRT that is capable of or updated to support group reporting, the group would aggregate the data by adding together the numerators and denominators for each MIPS eligible clinician within the group for whom the group has data captured in their CEHRT. If an individual MIPS eligible clinician meets the criteria to exclude a measure, their data can be excluded from the calculation of that particular measure only.
We understand and agree that it can be difficult to identify unique patients across a group for the purposes of aggregating performance on the advancing care information measures, particularly when that group is using multiple CEHRT systems. We further recognize that for 2017, groups may be using systems which are certified to different CEHRT editions further adding to this challenge. We consider “unique patients” to be individual patients treated by the group who would typically be counted as one patient in the denominator of an advancing care information measure. This patient may see multiple MIPS eligible clinicians within the group, or may see MIPS eligible clinicians at multiple group locations. When aggregating performance on advancing care information measures for group reporting, we do not require that the group determine that a patient seen by one MIPS eligible clinician (or at one location in the case of groups working with multiple CEHRT systems) is not also seen by another MIPS eligible clinician in the group or captured in a different CEHRT system. While this could result in the same patient appearing more than once in the denominator, we believe that the burden to the group of identifying these patients is greater than any gain in measurement accuracy. Accordingly, this final policy will allow groups some flexibility as to the method for counting unique patients in the denominators to accommodate these scenarios where aggregation may be hindered by systems capabilities across multiple CEHRT platforms. We note that this is consistent with our data aggregation policy for providers practicing in multiple locations under the EHR Incentive Program (77 FR 53982).
After consideration of the comments, we are finalizing our proposal to allow group reporting for the advancing care information performance category with the additional explanation of data aggregation requirements for group reporting provided in our response above, particularly as it relates to aggregating unique patients seen by the group.
For our final policy, we considered and rejected imposing a threshold for group reporting. For example, in future years we may require that groups can only submit their advancing care information performance category data as a group if 50 percent or more of their eligible patient encounters are captured in CEHRT. While we considered this as an option for 2017, the transition year of MIPS, we chose not to institute such a policy at this time and will instead consider it for future years. We are seeking comment in this final rule with comment period on what would be an appropriate threshold for group reporting in future years.
We note that group reporting policies for the MIPS program, including the other performance categories, are discussed in section II.E.5.a. of this final rule with comment period, and we refer readers to that section for additional discussion of group reporting.
Section 1848(q)(5)(E)(i)(IV) of the Act, as added by section 101(c) of the MACRA, states that 25 percent of the MIPS final score shall be based on performance for the advancing care information performance category. Therefore, we proposed at § 414.1375 that performance in the advancing care information performance category will comprise 25 percent of a MIPS eligible clinician's MIPS final score for payment year 2019 and each year thereafter. We received many comments in the MIPS and APMs RFI from stakeholders regarding the importance of flexible scoring for the advancing care information performance category and provisions for multiple performance pathways. We agree that this is the best approach moving forward with the adoption and use of CEHRT as it becomes part of a single coordinated program under the MIPS. For the reasons described here and previously in this preamble, we are proposing a methodology which balances the goals of incentivizing participation and reporting while recognizing exceptional performance by awarding points through a performance score. In this methodology, we proposed at § 414.1380(b)(4) that the score for the advancing care information performance category would be comprised of a score for participation and reporting, hereinafter referred to as the “base score,” and a score for performance at varying levels above the base score requirements, hereinafter referred to as the “performance score”.
The following is a summary of the comments we received regarding overall scoring for the advancing care information performance category.
To earn points toward the base score, a MIPS eligible clinician must report the numerator and denominator of certain measures specified for the advancing care information performance category (see measure specifications in section II.E.5.g.(7) (81 FR 28226 through 28228)), which are based on the measures adopted by the EHR Incentive Programs for Stage 3 in the 2015 EHR Incentive Programs final rule, to account for 50 percent (out of a total 100 percent) of the advancing care information performance category score. For measures that include a percentage-based threshold for Stage 3 of the EHR Incentive Program, we would not require those thresholds to be met for purposes of the advancing care information performance category under MIPS, but would instead require MIPS eligible clinicians to report the numerator (of at least one) and denominator (or a yes/no statement for applicable measures, which would be submitted together with data for the other measures) for each measure being reported. We note that for any measure requiring a yes/no statement, only a yes statement would qualify for credit under the base score. Under the proposal, the base score of the advancing care information performance category would incorporate the objective and measures adopted by the EHR Incentive Programs with an emphasis on privacy and security. We proposed two variations of a scoring methodology for the base score, a primary and an alternate proposal, which are outlined below. Both proposals would require the MIPS eligible clinician to meet the requirement to protect patient health information created or maintained by CEHRT to earn any score within the advancing care information performance category; failure to do so would result in a base score of zero, a performance score of zero (discussed in section II.E.5.g of the proposed rule (81 FR 28221), and an advancing care
The primary proposal at section II.E.5.g.(6)(b)(ii) of the proposed rule (81 FR 28221) would require a MIPS eligible clinician to report the numerator (of at least one) and denominator or yes/no statement (only a yes statement would qualify for credit under the base score) for a subset of measures adopted by the EHR Incentive Program for EPs in the 2015 EHR Incentive Programs final rule. In an effort to streamline and simplify the reporting requirements under the MIPS, and reduce reporting burden on MIPS eligible clinicians, we proposed that two objectives (Clinical Decision Support and Computerized Provider Order Entry) and their associated measures would not be required for reporting the advancing care information performance category. Given the consistently high performance on these two objectives in the EHR Incentive Program with EPs accomplishing a median score of over 90 percent for the last 3 years, we stated our belief that these objectives and measures are no longer an effective measure of EHR performance and use. In addition, we do not believe these objectives and associated measures contribute to the goals of patient engagement and interoperability, and thus, we believe these objectives can be removed in an effort to reduce reporting burden without negatively impacting the goals of the advancing care information performance category. We note that the removed objectives and associated measures would still be required as part of ONC's functionality standards for CEHRT, however, MIPS eligible clinicians would not be required to report the numerator and denominator or yes/no statement for those measures. In the 2015 EHR Incentive Programs final rule we also established that, for measures that were removed, the technology requirements would still be a part of the definition of CEHRT. For example, in that final rule, the Stage 1 Objective to Record Demographics was removed, but the technology and standard for this function in the EHR were still required (80 FR 62784). This means that the MIPS eligible clinician would still be required to have these functions as a part of their CEHRT.
The alternate proposal at section II.E.5.g.(6)(b)(iii) of the proposed rule (81 FR 28222) would require a MIPS eligible clinician to report the numerator (of at least one) and denominator or yes/no statement (only a yes statement would qualify for credit under the base score) for all objectives and measures adopted for Stage 3 in the 2015 EHR Incentive Programs final rule to earn the base score portion of the advancing care information performance category, which would include reporting a yes/no statement for CDS and a numerator and denominator for CPOE objectives. We included these objectives in the alternate proposal as MIPS eligible clinicians may believe the continued measurement of these objectives is valuable to the continued use of CEHRT as this would maintain the previously established objectives under the EHR Incentive Program.
We stated our belief that both proposed approaches to the base score are consistent with the statutory requirements under HITECH and previously established CEHRT requirements as we transition to MIPS. We also believe both approaches, in conjunction with the advancing care information performance score, recognize the need for greater flexibility in scoring CEHRT use across different clinician types and practice settings by allowing MIPS eligible clinicians to focus on the objectives and measures most applicable to their practice.
In regard to the base score calculation, most commenters requested that we remove the all-or-nothing scoring of the base score. Some asked that CMS give clinicians the option to report on a subset of measures to satisfy the base score. Many requested partial credit. Some commenters expressed concern that not reporting at least a numerator of one for the base measures will result in a score or zero for the entire category. A commenter proposed reporting a zero numerator or denominator on a measure would satisfy successfully submitting data, and thus, the clinician should achieve full points for the base score. Another recommended CMS grant credit for each reported measure under the base score and make clear that a physician will not fail the entire advancing care category if they fail to report all base score measures.
Commenters also suggested giving full credit in the advancing care information performance category if a MIPS eligible clinician attests to using technology certified to the 2014 or 2015 Edition for MIPS year 1, and 75 percent credit toward advancing care information performance category for subsequent years. Another asked that 50 percent in the base score be awarded to clinicians that implemented CEHRT for at least 90 days of the performance period to ease newer users into EHR. While most requested less stringent requirements, some thought that it is too easy to achieve the 50 percent base score. Others believed the “one patient threshold” for advancing care information performance category reporting for all measures in the base score is far too low.
We are finalizing our policy that a MIPS eligible clinician must report either a one in the numerator for numerator/denominator measures, or a “yes” response for yes/no measures in order to earn points in the base score, and a MIPS eligible clinician must report all required measures in the base score in order to earn a score in the advancing care information performance category. We note that the remainder of a MIPS eligible clinician's score will be based on performance and/or meeting the requirements to earn a bonus score for Public Health and Clinical Data Registry Reporting or improvement activities as described in section II.E.5.g.(7)(b) and II.E.5.g.(2)(b) of this final rule with comment period.
In the 2015 EHR Incentive Programs final rule (80 FR 62832), we finalized the Protect Patient Health Information objective and its associated measure for Stage 3, which requires EPs to protect electronic protected health information (ePHI, as defined in 45 CFR 160.103) created or maintained by the CEHRT through the implementation of appropriate technical, administrative, and physical safeguards. As privacy and security is of paramount importance and applicable across all objectives, the Protect Patient Health Information objective and measure would be an overarching requirement for the base score under both the primary proposal and alternate proposal, and therefore would be an overarching requirement for the advancing care information performance category. We proposed that a MIPS eligible clinician must meet this objective and measure to earn any score within the advancing care information performance category. Failure to do so would result in a base score of zero under either the primary proposal or alternate outlined proposal, as well as a performance score of zero (discussed in section II.E.5.g. of the proposed rule (81 FR 28215) and an advancing care information performance category score of zero.
The following is a summary of the comments we received regarding our proposal to require that a MIPS eligible clinician must meet the Protect Patient Health Information objective and measure to earn any score within the advancing care information performance category.
We are finalizing the requirement that a MIPS eligible clinician must meet the Protect Patient Health Information objective and measure in order to earn any score within the advancing care information performance category.
In the 2015 EHR Incentive Programs final rule (80 FR 62829-62871), we finalized certain objectives and measures EPs would report to demonstrate meaningful use of CEHRT for Stage 3. Under our proposal for the base score of the advancing care information performance category, MIPS eligible clinicians would be required to submit the numerator (of at least one) and denominator, or yes/no statement as appropriate (only a yes statement would qualify for credit under the base score), for each measure within a subset of objectives (Electronic Prescribing, Patient Electronic Access to Health Information, Care of Coordination Through Patient Engagement, Health Information Exchange, and Public Health and Clinical Data Registry Reporting) adopted in the 2015 EHR Incentive Programs final rule for Stage 3 to account for the base score of 50 percent of the advancing care information performance category score. Successfully submitting a numerator and denominator or yes/no statement for each measure of each objective would earn a base score of 50 percent for the advancing care information performance category. As proposed in the proposed rule, failure to meet the submission criteria (numerator/denominator or yes/no statement as applicable) and measure specifications (81 FR 28226 through 28230) for any measure in any of the objectives would result in a score of zero for the advancing care information performance category base score, a performance score of zero (discussed in section II.E.5.g. of the proposed rule 81 FR 28215) and an advancing care information performance category score of zero.
For the Public Health and Clinical Data Registry Reporting objective there is no numerator and denominator to measure; rather, the measure is a “yes/no” statement of whether the MIPS eligible clinician has completed the measure, noting that only a yes statement would qualify for credit under the base score. Therefore we proposed that MIPS eligible clinicians would include a yes/no statement in lieu of the numerator/denominator statement within their submission for the advancing care information performance category for the Public Health and Clinical Data Registry Reporting objective. We further proposed that, to earn points in the base score, a MIPS eligible clinician would only need to complete submission on the Immunization Registry Reporting measure of this objective. Completing any additional measures under this objective would earn one additional bonus point in the advancing care information performance category score. For further information on this proposed objective, we direct readers to 81 FR 28230.
Under our alternate proposal for the base score of the advancing care information performance category, a MIPS eligible clinician would be required to submit the numerator (of at least one) and denominator, or yes/no statement as appropriate, for each measure, for all objectives and measures for Stage 3 in the 2015 EHR Incentives Program final rule (80 FR 62829-62871) as outlined in Table 7 of the proposed rule (81 FR 28223). Successfully submitting a numerator and denominator for each measure of each objective would earn a base score of 50 percent for the advancing care information performance category. Failure to meet the submission requirements, or measure specifications for any measure in any of the objectives would result in a score of zero for the advancing care information performance category base score, a performance score of 0 (discussed in section II.E.5.g. of the proposed rule), and an advancing care information performance category score of 0.
We proposed the same approach in the alternate proposal for the Public Health and Clinical Data Registry Reporting objective as for the primary outlined proposal. We direct readers to 81 FR 28226 through 28230 for further details on the individual objectives and measures.
The following is a summary of the comments we received regarding our base score primary and alternate proposals which differ based on whether reporting the CDS and CPOE objectives would be required.
After consideration of the comments, we are finalizing our primary proposal with modifications described in section II.E.5.g.(6)(a) for the base score. This proposal does not require the reporting of the objectives and measures for CDS and CPOE. We note that the functionalities required for these objectives and associated measures are still required as part of ONC's certification criteria for CEHRT.
The following is a summary of the comments we received related to the bonus for Public Health and Clinical Data Registry Reporting.
After consideration of the comments we received, and for the reasons mentioned above, we are increasing the bonus score to 5 percent in the advancing care information performance category score for reporting to one or more public health or clinical data registries beyond the Immunization Registry Reporting measure. We note that in our effort to reduce the number of required measures in the base score and simplify reporting requirements, the Immunization Registry Reporting measure is no longer required as part of the base score, however MIPS eligible clinicians can earn 10 percent in the performance score for reporting this measure. Additionally, if the MIPS eligible clinician reports to one or more additional registries under the Public Health and Clinical Data Registry Reporting objective, they will earn the 5
In the 2015 EHR Incentive Programs final rule (80 FR 62772), we streamlined reporting for EPs by adopting a single set of objectives and measures for EPs regardless of their prior stage of participation. This was the first step in synchronizing the objectives and eliminating the separate stages of meaningful use in the EHR Incentive Program. In doing so, we also sought to provide some flexibility and to allow adequate time for EPs to move toward the more advanced use of EHR technology. This flexibility included alternate exclusions and specifications for EPs scheduled to demonstrate Stage 1 in 2015 and 2016 (80 FR 62788) and allowed clinicians to select either the Modified Stage 2 Objectives or the Stage 3 Objectives in 2017 (80 FR 62772) with all EPs moving to the Stage 3 Objectives in 2018. We note that in section II.E.5.g (81 FR 28218 and 28219) of the proposed rule, we proposed the requirements for MIPS eligible clinicians using various editions of CEHRT in 2017 as it relates to the objectives and measures they select to report.
In connection with that proposal, and in an effort not to unfairly burden MIPS eligible clinicians who are still utilizing EHR technology certified to the 2014 Edition certification criteria in 2017, we proposed at § 414.1380(b)(4) modified primary and alternate proposals for the base score for those MIPS eligible clinicians utilizing EHR technology certified to the 2014 Edition. We note that these modified proposals are the same as the primary and alternate outlined proposals in regard to scoring and data submission, but vary in the number of measures required under the Coordination of Care Through Patient Engagement and Health Information Exchange objectives as demonstrated in Table 8 of the proposed rule (81 FR 28224).
This approach allows MIPS eligible clinicians to continue moving toward advanced use of CEHRT in 2018, but allows for flexibility in the implementation of upgraded technology and in the selection of measures for reporting in 2017.
The following is a summary of the comments we received regarding the proposals for reporting on the Modified Stage 2 objectives and measures for the advancing care information performance category in 2017. We note that in this final rule with comment period we will refer to these measures as the 2017 Advancing Care Information Transition objectives and measures instead of Modified Stage 2, which is a term specific to the EHR Incentive Program.
After consideration of the comments we received, we are finalizing our proposal as proposed. We note that because we will accept a minimum of 90 consecutive days of data from the CY 2017 performance period, MIPS eligible clinicians who have EHR technology certified to the 2014 Edition and then transition to EHR technology certified to the 2015 Edition in 2017 have flexibility and may select which measures they want to report on for the 2017 performance period.
In addition to the base score, which includes submitting each of the objectives and measures to achieve 50 percent of the possible points within the advancing care information performance category, we proposed to allow multiple paths to achieve a score greater than the 50 percentage base score. The performance score is based on the priority goals established by us to focus on leveraging CEHRT to support the coordination of care. A MIPS eligible clinician would earn additional points above the base score for performance in the objectives and measures for Patient Electronic Access, Coordination of Care through Patient Engagement, and Health Information Exchange. These measures have a focus on patient engagement, electronic access and information exchange, which promote healthy behaviors by patients and lay the ground work for interoperability. These measures also have significant opportunity for improvement among MIPS eligible clinicians and the industry as a whole based on adoption and performance data. We believe this approach for achievement above a base score in the advancing care information performance category would provide MIPS eligible clinicians a flexible and realistic incentive towards the adoption and use of CEHRT.
We proposed at § 414.1380(b)(4) that, for the performance score, the eight associated measures under these three objectives would each be assigned a total of 10 possible points. For each measure, a MIPS eligible clinician may earn up to 10 percent of their performance score based on their performance rate for the given measure. For example, a performance rate of 95 percent on a given measure would earn 9.5 percentage points of the performance score for the advancing care information performance category. This scoring approach is consistent with the performance score approach outlined for other MIPS categories in the proposed rule. Table 9 of the proposed rule (81 FR 28225), provided an example of the proposed performance score methodology.
We noted that in this methodology, a MIPS eligible clinician has the potential to earn a performance score of up to 80 percent, which, in combination with the base score would be greater than the total possible 100 percent for the advancing care information performance category. We stated that this methodology would allow flexibility for MIPS eligible clinicians to focus on measures which are most relevant to their practice to achieve the maximum performance category score, while deemphasizing concentration in other measures which are not relevant to their practice.
This proposed methodology recognizes the importance of promoting health IT adoption and standards and the use of CEHRT to support quality improvement, interoperability, and patient engagement. We invited comments on our proposal.
The following is a summary of the comments we received regarding our proposal.
To determine the MIPS eligible clinician's overall advancing care information performance category score, we proposed to use the sum of the base score, performance score, and the potential Public Health and Clinical Data Registry Reporting bonus point. We note that if the sum of the MIPS eligible profession's base score (50 percent) and performance score (out of a possible 80 percent) with the Public Health and Clinical Data Registry Reporting bonus point are greater than 100 percent, we would apply an advancing care information performance category score of 100 percent. For example, if the MIPS eligible clinician earned the base score of 50 percent, a performance score of 60 percent and the bonus point for Public Health and Clinical Data Registry Reporting for a total of 111 percent, the MIPS eligible clinician's overall advancing care information performance category score would be 100 percent. The total percentage score (out of 100)
Under the final policy, a MIPS eligible clinician must report all required measures of the base score to earn any base score, and thus to earn any score in the advancing care information performance category. We understand that many commenters preferred that we do away entirely with the all-or-nothing approach to the base score and we have made adjustments to the base score to be responsive to those commenters' concerns. We note that section 1848(o)(2)(A) of the Act includes certain requirements that we have chosen to implement through certain measures such as e-Prescribing, Send a Summary of Care and Request/Accept Summary, and thus, we continue to require these measures in the advancing care information performance category base score. In addition, we have maintained the Security Risk Analysis measure as a required measure as we believe it is essential to protecting patient privacy as discussed in the proposed rule (81 FR 28221), and thus, we believe should be mandatory for reporting. We have also maintained Provide Patient Access as the fifth required measure under the base score because we believe it is essential for patients to have access to their health care information in order to improve health, provide transparency and drive patient engagement. To address commenters' concerns, we have reduced the total number of required measures in the base score to only these five, and moved other measures to the performance score where MIPS eligible clinicians can choose which measures to report based on their individual practice. While we believe all measures under the advancing care information performance category are of upmost importance, we acknowledge that we must balance the need for these data with data collection and reporting burden. Given the considerable reduction in required measures, we do not believe it is appropriate to increase the weight of the base score, and thus, it remains at 50 percent of the advancing care information performance category score.
The performance score builds upon the base score and is based on a MIPS eligible clinician's performance rate for each measure reported for the performance score (calculated using the numerator/denominator). A performance rate of 1-10 percent would earn 1 percentage point, a performance rate of 11-20 percent would earn 2 percentage points and so on. For example, if the clinician reports a numerator/denominator of 85/100 for the Patient-Specific Education measure, their performance rate would be 85 percent and they would earn 9 percentage points toward their performance score for the advancing care information performance category. With nine measures included in the performance score, a MIPS eligible clinician has the ability to earn up to 90 percentage points if they report all measures in the performance score.
We note that the measures under the Public Health and Clinical Data Registry Reporting objective are yes/no measures and do not have a numerator/denominator to calculate the performance rate. For the Immunization Registry Reporting measure, we will award 0 or 10 percentage points for the performance score (0 percent for a “no” response, 10 percent for a “yes” response). Active engagement with a public health or clinical data registry to meet any other measure associated with the Public Health and Clinical Data Registry Reporting objective will earn the MIPS eligible clinician a bonus of 5 percentage points as outlined in section II.E.5.g.(6)(b)f this final rule with comment period. MIPS eligible clinicians are not required to report the Immunization Registry Reporting measure in order to earn the bonus 5 percent for reporting to one or more additional registries.
Two of the measures in the base score are not included in the performance score. The Security Risk Analysis and e-Prescribing measures are required under the base score, but a MIPS eligible clinician will not earn additional points under the performance score for reporting these measures. Due to the critical nature of the Security Risk Analysis measure, and as we stated in the proposed rule, we believe this measure is of paramount importance and applicable across all objectives. Therefore, the Protect Patient Health Information objective and Security Risk Analysis measure are foundational requirements for the advancing care information performance category (81 FR 28221). For this reason, we are including it as a required measure in the base score, but are not awarding any additional score for performance. The e-Prescribing measure is one of the measures that fulfills a statutory requirement under section 1848(o)(2)(A) of the Act, and thus, we are requiring it as part of the base score. Given the historically high performance on this measure under the EHR Incentive Program with EPs achieving an average of 87 percent of all permissible prescriptions written and transmitted electronically using CEHRT in 2015, we are not including it in the performance score for the advancing care information performance category.
Under our final policy, MIPS eligible clinicians have the ability to earn an overall score for the advancing care information performance category of up to 155 percentage points, which will be capped at 100 percent when the base score, performance score and bonus score are all added together. We believe this addresses commenters' requests for additional opportunities to earn credit in all aspects of the advancing care information performance category including the base score, performance score and bonus score. In addition, we believe this scoring approach adds flexibility for MIPS eligible clinicians to choose measures that are most applicable to their practice and best represent their performance. While certain measures are still required for reporting, we have reduced this number from 11 required measures in the proposed base score to only five in this final policy. We have also increased the number of measures for which a MIPS eligible clinician has the ability to earn performance score credit from eight measures in the proposed performance score to nine in this final policy. We note that MIPS eligible clinicians can choose which of these measures to focus on for their performance score allowing clinicians to customize their reporting and score.
We are seeking comment on our final scoring methodology policies, and future enhancements to the methodology.
Section 1848(q)(5)(E)(ii) of the Act, as added by section 101(c) of the MACRA, provides that in any year in which the Secretary estimates that the proportion of EPs (as defined in section 1848(o)(5) of the Act) who are meaningful EHR users (as determined under section 1848(o)(2) of the Act) is 75 percent or greater, the Secretary may reduce the applicable percentage weight of the advancing care information performance category in the MIPS final score, but not below 15 percent, and increase the weightings of the other performance categories such that the total percentage points of the increase equals the total percentage points of the reduction. We note section 1848(o)(5) of the Act defines an EP as a physician, as defined in section 1861(r) of the Act. For purposes of applying section 1848(q)(5)(E)(ii) of the Act, we proposed to estimate the proportion of physicians as defined in section 1861(r) who are meaningful EHR users as those physician MIPS eligible clinicians who earn an advancing care information performance category score of at least 75 percent under our proposed scoring methodology for the advancing care information performance category for a performance period. This would require the MIPS eligible clinician to earn the advancing care information performance category base score of 50 percent, and an advancing care information performance score of at least 25 percent (or 24 percent plus the Public Health and Clinical Data Registry Reporting bonus point) for an overall performance category score of 75 percent for the advancing care information performance category. We are alternatively proposing to estimate the proportion of physicians as defined in section 1861(r) who are meaningful EHR users as those physician MIPS eligible clinicians who earn an advancing care information performance category score of 50 percent (which would only require the MIPS eligible clinician to earn the advancing care information performance category base score) under our proposed scoring methodology for the advancing care information performance category for a performance period, and we solicited comments on both of these proposed thresholds.
We proposed to base this estimation on data from the relevant performance period, if we have sufficient data available from that period. For example, if feasible, we would consider whether to reduce the applicable percentage weight of the advancing care information performance category in the MIPS final score for the 2019 MIPS payment year based on an estimation using the data from the 2017 performance period. We noted that in section II.E.5.g.(8) of the proposed rule (81 FR 28231-28232) we proposed to reweight the advancing care information performance category to zero for certain hospital-based physicians and other physicians. These physicians meet the definition of MIPS eligible clinicians, but would not be included in the estimation because the advancing care information performance category would be weighted at zero for them. We note that any adjustments of the performance category weights specified in section 1848(q)(5)(E) of the Act based on this policy would be established in future notice and comment rulemaking.
The following is a summary of the comments we received regarding our proposed definition of meaningful EHR user.
After consideration of the comments we received, in combination with our final scoring methodology and its impact on this policy, we are finalizing as proposed our primary proposal for purposes of applying section 1848(q)(5)(E)(ii) of the Act, to estimate the proportion of physicians as defined in section 1861(r) of the Act who are meaningful EHR users as those physician MIPS eligible clinicians who earn an advancing care information performance category score of at least 75 percent for a performance period. We will base this estimation on data from the relevant performance period, if we have sufficient data available from that period. We will not include in this estimation physicians for whom the advancing care information performance category is weighted at zero percent under section 1848(q)(5)(F) of the Act.
We proposed the objectives and measures for the advancing care information performance category of MIPS as outlined in the proposed rule. We noted that these objectives and measures have been adapted from the Stage 3 objectives and measures as finalized in the 2015 EHR Incentive Programs final rule (80 FR 62829 through 62871), however, we did not propose to maintain the previously established thresholds for MIPS. Any additional changes to the objectives and measures were outlined in the proposed rule. For a more detailed discussion of the Stage 3 objectives and measures, including explanatory material and defined terms, we refer readers to the 2015 EHR Incentive Programs final rule (80 FR 62829 through 62871).
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For this objective, we note that the 2015 EHR Incentive Program final rule included a discussion of controlled substances in the context of the Stage 3 objective and measure (80 FR 62834), which we understand from stakeholders has caused confusion. We therefore proposed for both MIPS and for the EHR Incentive Programs that health care providers would continue to have the option to include or not include controlled substances that can be electronically prescribed in the denominator. This means that MIPS eligible clinicians may choose to include controlled substances in the definition of “permissible prescriptions” at their discretion where feasible and allowable by law in the jurisdiction where they provide care. The MIPS eligible clinician may also choose not to include controlled substances in the definition of “permissible prescriptions” even if such electronic prescriptions are feasible and allowable by law in the jurisdiction where they provide care.
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We proposed the 2017 Advancing Care Information Transition objectives and measures for the advancing care information performance category of MIPS as outlined in this section of the proposed rule. We note that these objectives and measures have been adapted from the Modified Stage 2 objectives and measures as finalized in the 2015 EHR Incentive Programs final rule (80 FR 62793-62825), however, we have not proposed to maintain the previously established thresholds for MIPS. Any additional changes to the objectives and measures are outlined in this section of the proposed rule. For a more detailed discussion of the Modified Stage 2 objectives and measures, including explanatory material and defined terms, we refer readers to the 2015 EHR Incentive Programs final rule (80 FR 62793-62825).
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We note that the 2017 Advancing Care Information Transition objectives and measures specifications that we proposed are for those MIPS eligible clinicians that are using 2014 Edition CEHRT. We are referring to this as the “2017 Advancing Care Information Transition objectives and measures” in this final rule with comment period, although it was referred to in the proposed rule as the “Modified Stage 2 objectives and measures” set. In addition, in this final rule with comment period, we refer to the measures specified for the advancing care information performance category described in section II.E.5.g.(7) of the proposed rule (81 FR 28221 through 28223) that correlate to a Stage 3 as the “Advancing Care Information objectives and measures” although it was referred to in the proposed rule as “MIPS objectives and measures” set. We note that these terms more are more specific
We will be referring to these measures by their revised titles throughout the remainder of this final rule with comment period.
The following is a summary of the comments we received regarding the proposal to adopt the objectives and measures detailed at 81 FR 28226-28230 for the advancing care information performance category.
We additionally note that we have increased flexibility of our scoring methodology allowing MIPS eligible clinicians to focus on measures that best represent their practice in the performance score, and thus this measure is optional for reporting as part of the performance score.
We disagree with the suggestion to change Secure Messaging to a yes/no measure, or to change the numerator and denominator as this measure is meant to promote the sending of secure messages by the MIPS eligible clinician and not by patients. We believe that it is more appropriate for the numerator to consist of the number of patients found in the denominator to whom a secure electronic message is sent or in response
We disagree that the Advancing Care Information measure should be limited to only include recipients who possess CEHRT for the Request/Accept Summary of Care measure, as that would limit support for MIPS eligible clinicians exchanging health information with providers and clinicians across a wide range of settings. We further note that, consistent with the policy set forth in the 2015 EHR Incentive Programs final rule (80 FR 62852-62862), MIPS eligible clinicians and groups may send the electronic summary of care document via any electronic means so long as the MIPS eligible clinician sending the summary of care record is using the standards established for the creation of the electronic summary of care document.
Several commenters indicated that the Public Health Registry reporting objective would be better suited as an activity in the improvement activities performance category and public health registry reporting should be counted for points in that performance category rather than the advancing care information performance category.
We disagree that the Public Health and Clinical Data Registry reporting objective should be in the improvement activities performance category. The proposed measures in the Public Health and Clinical Data Registry Reporting objective focus on active, ongoing engagement with registries, as well as electronic submission of data, which we believe are within the scope of effectively using CEHRT to achieve the goals of the advancing care information performance category.
If a MIPS eligible clinician is reporting under the 2017 Advancing Care Information Transition objectives and measures, they may report cancer registry data under the Specialized Registry measure. If they are reporting under the Advancing Care Information objectives and measures, they would report under the Public Health Registry Reporting measure.
After consideration of the comments, we are finalizing our proposal for the Advancing Care Information objectives and measures and the 2017 Advancing Care Information Transition objectives and measures as proposed with modifications to correct language in certain measures as noted as follows:
We note that we will consider new measures for future years of the program, and invite comment on what types of EHR measures and measurement should be considered for inclusion in the program. In addition we invite comments on how to make the measures that we are adopting in this final rule more stringent in the future, especially in light of the statutory requirements.
In the 2015 EHR Incentive Programs final rule (80 FR 62829 through 62871) we outlined certain exclusions from the objectives and measures of meaningful use for EPs who perform low numbers of a particular action or activity for a given measure (for example, an EP who writes fewer than 100 permissible prescriptions during the EHR reporting period would be granted an exclusion for the Electronic Prescribing measure) or for EPs who had no office visits during the EHR reporting period. Moving forward, we believe that the proposed MIPS exclusion criteria as proposed at (81 FR 28173-28176) and as further discussed in section II.E.1. of this final rule with comment period, and advancing care information performance category scoring methodology together accomplish the same end as the previously established exclusions for the majority of the advancing care information performance category measures. By excluding from MIPS those clinicians who do not exceed the low-volume threshold (proposed in section II.E.3.c. of the proposed rule, as MIPS eligible clinicians who, during the performance period, have Medicare billing charges less than or equal to $10,000 and provide care for 100 or fewer Part B-enrolled Medicare beneficiaries), we believe exclusions for most of the individual advancing care information performance category measures are no longer necessary. The additional flexibility afforded by the proposed advancing care information performance category scoring methodology eliminates required thresholds for measures and allows MIPS eligible clinicians to focus on, and therefore report higher numbers for, measures that are more relevant to their practice.
We noted that EPs who write less than 100 permissible prescriptions during the EHR reporting period are allowed an exclusion for the e-Prescribing measure under the EHR Incentive Program (80 FR 62834), which we did not propose for MIPS. We note that the Electronic Prescribing objective would not be part of the performance score under our proposals, and thus, MIPS eligible clinicians who write very low numbers of permissible prescriptions would not be at a disadvantage in relation to other MIPS eligible clinicians when seeking to achieve a maximum advancing care information performance category score. For the purposes of the base score, we proposed that those MIPS eligible clinicians who write fewer than 100 permissible prescriptions in a performance period may elect to report their numerator and denominator (if they have at least one permissible prescription for the numerator), or they may report a null value. This is consistent with prior policy which allowed flexibility for clinicians in similar circumstances to choose an alternate exclusion (80 FR 62789).
In addition, in the 2015 EHR Incentive Programs final rule, we adopted a set of exclusions for the Immunization Registry Reporting measure under the Public Health and Clinical Data Registry Reporting objective (80 FR 62870). We recognize that some types of clinicians do not administer immunizations, and therefore proposed to maintain the previously established exclusions for the Immunization Registry Reporting measure. We therefore proposed that these MIPS eligible clinicians may elect to report their yes/no statement if applicable, or they may report a null value (if the previously established exclusions apply) for purposes of reporting the base score.
We note that we did not propose to maintain any of the other exclusions established under the EHR Incentive Program, however, we solicited comment on whether other exclusions should be considered under the advancing care information performance category under the MIPS.
The following is a summary of the comments we received regarding our exclusion proposal.
After consideration of the comments, we are finalizing our exclusion policy as proposed with the following modification. We are not finalizing the exclusions for the Immunization Registry Reporting measure under the Public Health and Clinical Data Registry Reporting objective for those MIPS eligible clinicians who do not administer immunizations as part of their practice.
As discussed in the proposed rule, section 101(b)(1)(A) of the MACRA amended section 1848(a)(7)(A) of the Act to sunset the meaningful use payment adjustment at the end of CY 2018. Section 1848(a)(7) of the Act includes certain statutory exceptions to the meaningful use payment adjustment under section 1848(a)(7)(A) of the Act. Specifically, section 1848(a)(7)(D) of the Act exempts hospital-based EPs from the application of the payment adjustment under section 1848(a)(7)(A) of the Act. In addition, section 1848(a)(7)(B) of the Act provides that the Secretary may exempt an EP who is not a meaningful EHR user for the EHR reporting period for the year from the application of the payment adjustment under section 1848(a)(7)(A) of the Act if the Secretary determines that compliance with the requirements for being a meaningful EHR user would result in a significant hardship, such as in the case of an EP who practices in a rural area without sufficient internet access. The MACRA did not maintain these statutory exceptions for the advancing care information performance category of the MIPS. Thus, the exceptions under sections 1848(a)(7)(B) and (D) of the Act are limited to the meaningful use payment adjustment under section 1848(a)(7)(A) of the Act and do not apply in the context of the MIPS.
Section 1848(q)(5)(F) of the Act provides, if there are not sufficient measures and activities applicable and available to each type of MIPS eligible clinician, the Secretary shall assign different scoring weights (including a weight of zero) for each performance category based on the extent to which the category is applicable to each type of MIPS eligible clinician, and for each measure and activity specified for each such category based on the extent to which the measure or activity is applicable and available to the type of MIPS eligible clinician.
We believe that under our proposals for the advancing care information performance category of the MIPS, there may not be sufficient measures that are applicable and available to certain types of MIPS eligible clinicians as outlined in the proposed rule, some of whom may have qualified for a statutory exception to the meaningful use payment adjustment under section 1848(a)(7)(A) of the Act. For the reasons stated in the proposed rule, we proposed to assign a weight of zero to the advancing care information performance category for purposes of calculating a MIPS final score for these MIPS eligible clinicians. We refer readers to section II.E.6. of the proposed rule for more information regarding how the quality, cost and improvement activities performance categories would be reweighted.
Section 1848(a)(7)(D) of the Act exempts hospital-based EPs from the application of the meaningful use payment adjustment under section 1848(a)(7)(A) of the Act. We defined a hospital-based EP for the EHR Incentive Program under § 495.4 as an EP who furnishes 90 percent or more of his or her covered professional services in sites of service identified by the codes used in the HIPAA standard transaction as an inpatient hospital or emergency room setting in the year preceding the payment year, or in the case of a payment adjustment year, in either of the 2 years before the year preceding such payment adjustment year. Under this definition, EPs that have 90 percent or more of payments for covered professional services associated with claims with Place of Service Codes 21 (inpatient hospital) or 23 (emergency department) are considered hospital-based (75 FR 44442).
We believe there may not be sufficient measures applicable and available to hospital-based MIPS eligible clinicians under our proposals for the advancing care information performance category of MIPS.
Hospital-based MIPS eligible clinicians may not have control over the decisions that the hospital makes regarding the use of health IT and CEHRT. These MIPS eligible clinicians therefore may have no control over the type of CEHRT available, the way that the technology is implemented and used, or whether the hospital continually invests in the technology to ensure it is compliant with ONC certification criteria. In addition, some of the specific advancing care information performance category measures, such as the Provide Patient Access measure under the Patient Electronic Access objective requires that patients have access to view, download and transmit their health information from the EHR which is made available by the health care clinician, in this case the hospital. Thus the measure is more attributable and applicable to the hospital and not to the MIPS eligible clinician, as the hospital controls the availability of the EHR technology. Further, the requirement under the Protect Patient Health Information objective to conduct a security risk analysis, would rely on the actions of the hospital, rather than the actions of the MIPS eligible clinician, as the hospital controls the access and availability and secure implementation of the EHR technology. In this case, the measure is again more attributable and applicable to the hospital than to the MIPS eligible clinician. Further, certain specialists (such as pathologists, radiologists and anesthesiologists) who often practice in a hospital setting and may be hospital-based MIPS eligible clinicians often lack face-to-face interaction with patients, and thus, may not have sufficient measures applicable and available to them under our proposals. For example, hospital-based MIPS eligible clinicians who lack face-to-face patient interaction may not have patients for which they could transfer or create an electronic summary of care record.
In addition, we noted that eligible hospitals and CAHs are subject to meaningful use requirements under sections 1886(b)(3)(B) and (n) and 1814(l) of the Act, respectively, which were not affected by the enactment of the MACRA. Eligible hospitals and CAHs are required to report on objectives and measures of meaningful use under the EHR Incentive Program, as outlined in the 2015 EHR Incentive Programs final rule. We noted the objectives and measures of the EHR Incentive Programs for eligible hospitals and CAHs are specific to these facilities, and are more applicable and better represent the EHR technology available in these settings.
For these reasons, we proposed to rely on section 1848(q)(5)(F) of the Act to assign a weight of zero to the advancing care information performance category for hospital-based MIPS eligible clinicians. We proposed to define a “hospital-based MIPS eligible clinician” at § 414.1305 as a MIPS eligible clinician who furnishes 90 percent or more of his or her covered professional services in sites of service identified by the codes used in the HIPAA standard transaction as an inpatient hospital or emergency room setting in the year preceding the performance period, otherwise stated as the year 3 years preceding the MIPS payment year. For example, under this proposal, hospital-based determinations would be made for the 2019 MIPS payment year based on covered professional services furnished in 2016. We also proposed, consistent with the EHR Incentive Program, that we would determine which MIPS eligible clinicians qualify as “hospital-based” for a MIPS payment year. We invited comments on these proposals.
In addition, we sought comment on how the advancing care information performance category could be applied to hospital-based MIPS eligible clinicians in future years of MIPS, and the types of measures that would be applicable and available to these types of MIPS eligible clinicians.
We also sought comment on whether the previously established 90 percent threshold of payments for covered professional services associated with claims with Place of Service (POS) Codes 21 (inpatient hospital) or 23 (emergency department) is appropriate, or whether we should consider lowering this threshold to account for hospital-based MIPS eligible clinicians who bill more than 10 percent of claims with a POS other than 21 or 23. Although we proposed a threshold of 90 percent, we are considering whether a lower threshold would be more appropriate for hospital-based MIPS eligible clinicians. In particular, we are interested in what factors should be applied to determine the threshold for hospital-based MIPS eligible clinicians. We will continue to evaluate the data to determine whether there are certain thresholds which naturally define a hospital-based MIPS eligible clinician.
The following is a summary of the comments we received regarding our proposal for defining hospital-based MIPS eligible clinicians.
After consideration of the public comments and the data we have available, we are finalizing our proposal for MIPS under § 414.1305 with the following modifications. Under the MIPS, a hospital-based MIPS eligible clinicians is defined as a MIPS eligible clinician who furnishes 75 percent or more of his or her covered professional services in sites of service identified by the Place of Service (POS) codes used in the HIPAA standard transaction as an inpatient hospital (POS 21), on campus outpatient hospital (POS 22), or emergency room (POS 23) setting, based on claims for a period prior to the performance period as specified by CMS. We intend to use claims with dates of service between September 1 of the calendar year 2 years preceding the performance period through August 31 of the calendar year preceding the performance period, but in the event it is not operationally feasible to use claims from this time period, we will use a 12-month period as close as practicable to this time period.
We note that this expanded definition of hospital-based MIPS eligible clinician will include a greater number of MIPS eligible clinicians than the previously proposed definition. We have expanded this definition because we believe it better represents hospital-based eligible clinicians and acknowledges the challenges they face with regard to EHR reporting as stated above. For the reasons stated in the proposed rule, our assumption remains that MIPS eligible clinicians who are determined hospital-based do not have sufficient advancing care information measures applicable to them, and thus we will reweight the advancing care information performance category to zero percent of the MIPS final score for the MIPS payment year in accordance with section 1848(q)(5)(F) of the Act. If a MIPS eligible clinician disagrees with our assumption and believes there are sufficient advancing care information measures applicable to them, they have the option to report the advancing care information measures for the performance period for the MIPS payment year for which they are determined hospital-based. However, if a MIPS eligible clinician who is determined hospital-based chooses to report on the advancing care information measures, they will be scored on the advancing care information performance category like all other MIPS eligible clinicians, and the performance category will be given the weighting prescribed by section 1848(q)(5)(E) of the Act regardless of their advancing care information performance category score.
Section 1848(a)(7)(B) of the Act provides that the Secretary may exempt an EP who is not a meaningful EHR user for the EHR reporting period for the year from the application of the payment adjustment under section 1848(a)(7)(A) of the Act if the Secretary determines that compliance with the requirements for being a meaningful EHR user would result in a significant hardship. In the Stage 2 final rule (77 FR 54097-54100),
• Insufficient Internet Connectivity (as specified in 42 CFR 495.102(d)(4)(i)).
• Extreme and Uncontrollable Circumstances (as specified in 42 CFR 495.102(d)(4)(iii)).
• Lack of Control over the Availability of CEHRT (as specified in 42 CFR 495.102(d)(4)(iv)(A)).
• Lack of Face-to-Face Patient Interaction (as specified in 42 CFR 495.102(d)(4)(iv)(B)).
We believe that under our proposals for the advancing care information performance category, there may not be sufficient measures applicable and available to MIPS eligible clinicians within the categories above. For these MIPS eligible clinicians, we proposed to rely on section 1848(q)(5)(F) of the Act to re-weight the advancing care information performance category to zero.
Sufficient internet access is fundamental to many of the measures proposed for the advancing care information performance category. For example, the e-Prescribing measure requires sufficient access to the Internet to transmit prescriptions electronically, and the Secure Messaging measure requires sufficient Internet access to receive and respond to patient messages. These measures may not be applicable to MIPS eligible clinicians who practice in areas with insufficient internet access. We proposed to require MIPS eligible clinicians to demonstrate insufficient internet access through an application process in order to be considered for a reweighting of the advancing care information performance category. The application would have to demonstrate that the MIPS eligible clinicians lacked sufficient internet access, during the performance period, and that there were insurmountable barriers to obtaining such infrastructure, such as a high cost of extending the internet infrastructure to their facility.
Extreme and uncontrollable circumstances, such as a natural disaster in which an EHR or practice building are destroyed, can happen at any time and are outside a MIPS eligible clinician's control. If a MIPS eligible clinician's CEHRT is unavailable as a result of such circumstances, the measures specified for the advancing care information performance category may not be available for the MIPS eligible clinician to report. We proposed that these MIPS eligible clinicians submit an application to include the circumstances by which the EHR technology was unavailable, and for what period of time it was unavailable, to be considered for reweighting of their advancing care information performance category.
In the Stage 2 final rule (77 FR 54100) we discussed EPs who practice at multiple locations, and may not have the ability to impact their practices' health IT decisions. We noted the case of surgeons using ambulatory surgery centers or a physician treating patients in a nursing home who does not have any other vested interest in the facility, and may have no influence or control over the health IT decisions of that facility. If MIPS eligible clinicians lack control over the CEHRT in their practice locations, then the measures specified for the advancing care information performance category may not be available to them for reporting. To be considered for a reweighting of the advancing care information performance category, we proposed that these MIPS eligible clinicians would need to submit an application demonstrating that a majority (50 percent or more) of their outpatient encounters occur in locations where they have no control over the health IT decisions of the facility, and request their advancing care information performance category score be reweighted to zero. We noted that in such cases, the MIPS eligible clinician must have no control over the availability of CEHRT. Control does not imply final decision-making authority. For example, we would generally view MIPS eligible clinicians practicing in a large, group as having control over the availability of CEHRT, because they can influence the group's purchase of CEHRT, they may reassign their claims to the group, they may have a partnership/ownership stake in the group, or any payment adjustment would affect the group's earnings and the entire impact of the adjustment would not be borne by the individual MIPS eligible clinician. These MIPS eligible clinicians can influence the availability of CEHRT and the group's earnings are directly affected by the payment adjustment. Thus, such MIPS eligible clinicians would not, as a general rule, be viewed as lacking control over the availability of CEHRT and would not be eligible for their advancing care information performance category to be reweighted based on their membership in a group practice that has not adopted CEHRT.
In the Stage 2 final rule (77 FR 54099), we noted the challenges faced by EPs who lack face-to-face interaction with patients (EPs that are non-patient facing), or lack the need to provide follow-up care with patients. Many of the measures proposed under the advancing care information performance category require face-to-face interaction with patients, including all eight of the measures that make up the three performance score objectives (Patient Electronic Access, Coordination of Care Through Patient Engagement and Health Information Exchange). Because these proposed measures rely so heavily on face-to-face patient interactions, we do not believe there would be sufficient measures applicable to non-patient facing MIPS eligible clinicians under the advancing care information performance category. We proposed to automatically reweight the advancing care information performance category to zero for a MIPS eligible clinician who is classified as a non-patient facing MIPS eligible clinician (based on the number of patient-facing encounters billed during a performance period) without requiring an application to be submitted by the MIPS eligible clinician. We refer readers to section II.E.1.b. of the proposed rule for further discussion of non-patient facing MIPS eligible clinicians. We also sought comment on how the advancing care information performance category could be applied to non-patient facing MIPS eligible clinicians in future years of MIPS, and the types of measures that would be applicable and available to these types of MIPS eligible clinicians.
We proposed that all applications for reweighting the advancing care information performance category be submitted by the MIPS eligible clinician or designated group representative in the form and manner specified by CMS. We proposed that all applications may be submitted on a rolling basis, but must be received by us no later than the close of the submission period for the relevant performance period, or a later date specified by us. For example, for the 2017 performance period, applications must be submitted no later than March 31, 2018 (or later date as specified by us) to be considered for reweighting the advancing care information performance category for the 2019 MIPS payment year. An application would need to be submitted annually to be considered for reweighting each year.
The following is a summary of comments received.
After consideration the comments, we are finalizing our policy to re-weight the advancing care information performance category to zero percent of the MIPS final score for MIPS eligible clinicians facing a significant hardships as proposed. For the reasons discussed in the proposed rule, we continue to assume that these clinicians may not have sufficient measures applicable and available to them for the advancing care information performance category. Should a MIPS eligible clinician apply for their advancing care information performance category to be reweighted under this policy but subsequently determine that their situation has changed such that they believe there are sufficient measures applicable and available to them for the advancing care information performance category, they may report on the measures. If they choose to report, they will be scored on the advancing care information performance category like any other MIPS eligible clinician, and the category will be given the weighting prescribed by section 1848(q)(5)(E) of the Act regardless of the MIPS eligible clinician's advancing care information performance category score.
The definition of a MIPS eligible clinician under section 1848(q)(1)(C) of the Act includes certain non-physician practitioners, including Nurse Practitioners (NPs), Physicians Assistants (PAs), Certified Registered Nurse Anesthetists (CRNAs) and Clinical Nurse Specialists (CNSs)). CRNAs and CNSs are not eligible for the incentive payments under Medicare or
Because many of these non-physician clinicians are not eligible to participate in the Medicare and/or Medicaid EHR Incentive Program, we have little evidence as to whether there are sufficient measures applicable and available to these types of MIPS eligible clinicians under our proposals for the advancing care information performance category. The low numbers of NPs and PAs who have attested for the Medicaid incentive payments may indicate that EHR Incentive Program measures required to earn the incentive are not applicable or available, and thus, would not be applicable or available under the advancing care information performance category. For these reasons, we proposed to rely on section 1848(q)(5)(F) of the Act to assign a weight of zero to the advancing care information performance category if there are not sufficient measures applicable and available to NPs, PAs, CRNAs, and CNSs. We would assign a weight of zero only in the event that an NP, PA, CRNA, or CNS does not submit any data for any of the measures specified for the advancing care information performance category. We encourage all NPs, PAs, CRNAs, and CNSs to report on these measures to the extent they are applicable and available, however, we understand that some NPs, PAs, CRNAs, and CNSs may choose to accept a weight of zero for this performance category if they are unable to fully report the advancing care information measures. We believe this approach is appropriate for the first MIPS performance period based on the payment consequences associated with reporting, the fact that many of these types of MIPS eligible clinicians may lack experience with EHR use, and our current uncertainty as to whether we have proposed sufficient measures that are applicable and available to these types of MIPS eligible clinicians. We noted that we would use the first MIPS performance period to further evaluate the participation of these MIPS eligible clinicians in the advancing care information performance category and would consider for subsequent years whether the measures specified for this category are applicable and available to these MIPS eligible clinicians.
We invited comments on our proposal. We additionally sought comment on how the advancing care information performance category could be applied to NPs, PAs, CRNAs, and CNSs in future years of MIPS, and the types of measures that would be applicable and available to these types of MIPS eligible clinicians.
The following is a summary of the comments we received regarding our proposal.
After consideration of the comments, we are finalizing our NPs, PAs, CRNAs, and CNSs policy as proposed. These MIPS eligible clinicians may choose to submit advancing care information measures should they determine that these measures are applicable and available to them; however, we note that if they choose to report, they will be scored on the advancing care information performance category like all other MIPS eligible clinicians and the performance category will be given the weighting prescribed by section 1848(q)(5)(E) of the Act regardless of
In the 2015 EHR Incentive Programs final rule we adopted an alternate method for demonstrating meaningful use for certain Medicaid EPs that would be available beginning in 2016, for EPs attesting for an EHR reporting period in 2015 (80 FR 62900). Certain Medicaid EPs who previously received an incentive payment under the Medicaid EHR Incentive Program, but failed to meet the eligibility requirements for the program in subsequent years, are permitted to attest using the CMS Registration and Attestation system for the purpose of avoiding the Medicare payment adjustment (80 FR 62900). However, as discussed in the proposed rule, section 101(b)(1)(A) of the MACRA amended section 1848(a)(7)(A) of the Act to sunset the meaningful use payment adjustment for Medicare EHR Incentive Program EPs at the end of CY 2018. This means that after the CY 2018 payment adjustment year, there will no longer be a separate Medicare EHR Incentive Program for EPs, and therefore Medicaid EPs who may have used this alternate method for demonstrating meaningful use cannot potentially be subject to a payment adjustment under the Medicare EHR Incentive Program at that time. Accordingly, there will no longer be a need for this alternate method of demonstrating meaningful use after the CY 2018 payment adjustment year.
Similarly, beginning in 2014, states were required to collect, upload and submit attestation data for Medicaid EPs for the purposes of demonstrating meaningful use to avoid the Medicare payment adjustment (80 FR 62915). This form of reporting will also no longer need to continue with the sunset of the meaningful use payment adjustment for Medicare EHR Incentive Program EPs at the end of CY 2018. Accordingly, we proposed to amend the reporting requirement described at 42 CFR 495.316(g) by adding an ending date such that after the CY 2018 payment adjustment year states would no longer be required to report on meaningful EHR users.
We noted that the Medicaid EHR Incentive Program for EPs was not impacted by the MACRA and the requirement under section 1848(q) of the Act to establish the MIPS program. We did not propose any changes to the objectives and measures previously established in rulemaking for the Medicaid EHR Incentive Program, and thus, EPs participating in that program must continue to report on the objectives and measures under the guidelines and regulations of that program.
Accordingly, reporting on the measures specified for the advancing care information performance category under MIPS cannot be used as a demonstration of meaningful use for the Medicaid EHR Incentive Programs. Similarly, a demonstration of meaningful use in the Medicaid EHR Incentive Programs cannot be used for purposes of reporting under MIPS.
Therefore, MIPS eligible clinicians who are also participating in the Medicaid EHR Incentive Programs must report their data for the advancing care information performance category through the submission methods established for MIPS in order to earn a score for the advancing care information performance category under MIPS and must separately demonstrate meaningful use in their state's Medicaid EHR Incentive Program in order to earn a Medicaid incentive payment. The Medicaid EHR Incentive Program continues through payment year 2021, with 2016 being the final year an EP can begin receiving incentive payments (§ 495.310(a)(1)(iii)). We solicited comments on alternative reporting or proxies for EPs who provide services to both Medicaid and Medicare patients and are eligible for both MIPS and the Medicaid EHR Incentive Payment.
The following is a summary of the comments we received regarding our proposal to separate the reporting requirements of MIPS and the Medicaid EHR Incentive Programs:
We remind commenters that while MIPS eligible clinicians would be required to meet the requirements of the advancing care information performance category to earn points toward their MIPS final score, there is no longer a requirement that EPs demonstrate meaningful use under the Medicaid EHR incentive program as a way to avoid the Medicare EHR payment adjustments. However, MIPS eligible clinicians who meet the Medicaid EHR Incentive Program eligibility requirements are encouraged to additionally participate in the Medicaid EHR Incentive Program to be eligible for Medicaid incentive payments through program year 2021.
We are finalizing our Medicaid policy as proposed.
Under section 1848(q)(1)(C)(ii) of the Act, as added by section 101(c)(1) of MACRA and as discussed in section II.F.5. of this final rule with comment period, Qualifying APM Participants (QPs) are not MIPS eligible clinicians and are thus excluded from MIPS payment adjustments. Partial Qualifying APM Participants (Partial QPs) are also not MIPS eligible clinicians unless they opt to report and be scored under MIPS. All other eligible clinicians participating in APMs who are MIPS eligible clinicians are subject to MIPS requirements, including reporting requirements and payment adjustments. However, most current APMs already assess their participants on cost and quality of care and require engagement in certain care improvement activities.
We proposed at § 414.1370 to establish a scoring standard for MIPS eligible clinicians participating in certain types of APMs (“APM scoring standard”) to reduce participant reporting burden by eliminating the need for such APM eligible clinicians to submit data for both MIPS and their respective APMs. In accordance with section 1848(q)(1)(D)(i) of the Act, we proposed to assess the performance of a group of MIPS eligible clinicians in an APM Entity that participates in certain types of APMs based on their collective performance as an APM Entity group, as defined at § 414.1305.
In addition to reducing reporting burden, we sought to ensure that eligible clinicians in APM Entity groups are not assessed in multiple ways on the same performance activities. For instance, performance on the generally applicable cost measures under MIPS could contribute to upward or downward adjustments to payments under MIPS in a way that is not aligned with the strategy in an ACO initiative for reducing total Medicare costs for a specified population of beneficiaries attributed through the unique ACO initiative's attribution methodology. Depending on the terms of the particular APM, we believe similar misalignments could be common between the MIPS quality and cost performance categories and the evaluation of quality and cost in APMs. We believe requiring eligible clinicians in APM Entity groups to submit data, be scored on measures, and be subject to payment adjustments that are not aligned between MIPS and an APM could potentially undermine the validity of testing or performance evaluation under the APM. We also believe imposition of these requirements would result in reporting activity that provides little or no added value to the assessment of eligible clinicians, and could confuse eligible clinicians as to which CMS incentives should take priority over others in designing and implementing care activities.
We proposed to apply the APM scoring standard to MIPS eligible clinicians in APM Entity groups participating in certain APMs (“MIPS APMs”) that meet the criteria listed below (and would be identified as “MIPS APMs” on the CMS Web site). In the proposed rule, we defined the proposed criteria for MIPS APMs, the MIPS performance period for APM Entity groups, the proposed MIPS scoring methodology for APM Entity groups, and other information related to the APM scoring standard (81 FR 28234-28247).
We proposed at § 414.1370 to specify that the APM scoring standard under MIPS would only be applicable to eligible clinicians participating in MIPS APMs, which we proposed to define as APMs (as defined in section II.F.4. of the proposed rule) that meet the following criteria: (1) APM Entities participate in the APM under an agreement with CMS; (2) the APM requires that APM Entities include at least one MIPS eligible clinician on a Participation List; and (3) the APM bases payment incentives on performance (either at the APM Entity or eligible clinician level) on cost/utilization and quality measures. We understood that under some APMs the APM Entity may enter into agreements with clinicians or entities that have supporting or ancillary roles to the APM Entity's performance under the APM, but are not participating under the APM Entity and therefore are not on a Participation List. We proposed not to consider eligible clinicians under such arrangements to be participants for purposes of the APM Entity group to which the APM scoring standard would apply. We also proposed that the APM scoring standard would not apply for certain APMs in which the APM Entities participate under statute or our regulations rather than under an agreement with us. We solicited comments on how the APM scoring standard should apply to those APMs as well.
The criteria for the identification of MIPS APMs are independent of the criteria for Advanced APM determinations discussed in section II.F.4. of this final rule with comment period, so a MIPS APM may or may not also be an Advanced APM. As such, it would be possible that an APM meets all three proposed criteria to be a MIPS APM, but does not meet the Advanced APM criteria described in section II.F.4. of this final rule with comment period. Conversely, it would be possible that an Advanced APM does not meet the criteria listed above because it does not include MIPS eligible clinicians as participants.
The APM scoring standard would not apply to MIPS eligible clinicians involved in APMs that include only facilities as participants. APMs that do not base payment on cost/utilization and quality measures also would not meet the proposed criteria for the APM scoring standard. Instead, MIPS eligible clinicians participating in these APMs would need to meet the generally applicable MIPS data submission requirements for the MIPS performance period, and their performance would be assessed using the generally applicable MIPS standards, either as individual eligible clinicians or as a group under MIPS.
As we explained in the proposed rule, we believe the proposed APM scoring standard would help alleviate certain duplicative, unnecessary, or competing data submission requirements for MIPS eligible clinicians participating in MIPS APMs. However, we were interested in public comments on alternative methods that could reduce MIPS data submission requirements to enable MIPS eligible clinicians participating in Advanced APMs to maximize their focus on the care delivery redesign necessary to succeed within the Advanced APM while maintaining the statutory framework that excludes only certain eligible clinicians from MIPS and reducing reporting burden on Advanced APM participants.
We proposed that the APM scoring standard would not apply to MIPS eligible clinicians participating in APMs that are not MIPS APMs. Rather, such MIPS eligible clinicians would submit data to MIPS and have their performance assessed either as an individual MIPS eligible clinician or group as described in section II.E.2 of this final rule with comment period. Some APMs may involve certain types of MIPS eligible clinicians that are affiliated with an APM Entity but not included in the APM Entity group because they are not participants of the APM Entity. We proposed that even if the APM meets the criteria to be a MIPS APM, MIPS eligible clinicians who are not included in the MIPS APM Participation List would not be considered part of the participating APM Entity group for purposes of the
The following is a summary of the comments we received regarding our proposals for the criteria for an APM to be a MIPS APM, and for the APM scoring standard to apply only to MIPS eligible clinicians who are included in the APM Entity group on a MIPS APM Participation List.
Particularly relevant to facility- or hospital-based APMs (because some do not require APM Entities to maintain Participation Lists), any MIPS eligible clinicians that do not qualify as QPs or Partial QPs, and are not included on a Participation List of an APM Entity that participates in the MIPS APM, would report to MIPS and be scored according to the generally applicable MIPS requirements for an individual or group. The APM scoring standard is intended to ensure that the MIPS eligible clinicians that are directly and collectively accountable for beneficiary attribution and quality and cost/utilization performance under the MIPS APM are able to focus their efforts on the care transformation objectives of the APM rather than on potentially duplicative reporting of measures. We note that the MIPS eligible clinicians that are subject to the APM scoring
We agree with commenters that we should continue to consider whether there are opportunities for additional APMs, including existing episode payment models, to become MIPS APMs. As we work toward that goal we believe we should move forward with the policy to avoid potentially duplicative or conflicting reporting or incentives for MIPS eligible clinicians participating in APMs that currently meet the MIPS APM criteria. In the future, we may consider amending existing APMs to meet MIPS APM criteria. However, as stated in the previous response, we do not believe that application of the APM scoring standard should be expanded to include MIPS eligible clinicians such as Affiliated Practitioners whose roles are not directly linked to quality and cost/utilization measures under the APM, or that the MIPS APM criteria should be expanded to include APMs that do not tie payment incentives to performance on quality and cost/utilization measures or APMs (such as CJR) that do not require APM Entities to have at least one eligible clinician on a Participation List. In these instances, we do not believe the requirements of the APM are sufficiently connected to MIPS reporting requirements and scoring such that there is significant potential for duplicative reporting or conflicting incentives between the APM and MIPS, the avoidance of which is the underlying purpose of the APM scoring standard.
After considering these comments, we are finalizing the criteria for an APM to be a MIPS APM as proposed with one modification to the first criterion in order to encompass APMs with terms defined through law or regulation. MIPS APMs are APMs that meet the following criteria: (1) APM Entities participate in the APM under an agreement with CMS or by law or regulation; (2) the APM requires that APM Entities include at least one MIPS eligible clinician on a Participation List; and (3) the APM bases payment incentives on performance (either at the APM Entity or eligible clinician level) on cost/utilization and quality measures.
Below we describe in detail how MIPS APM participants will be identified from an APM Participation List to be included in the APM Entity group under the APM scoring standard.
We are also finalizing the proposal that the APM scoring standard does not apply to MIPS eligible clinicians who are not on a Participation List for an APM Entity group in a MIPS APM. MIPS eligible clinicians who are not part of the APM Entity group to which the APM scoring standard applies may choose to report to MIPS as individuals or groups according to the generally applicable MIPS rules.
We proposed that the performance period for MIPS eligible clinicians participating in MIPS APMs would match the generally applicable performance period for MIPS proposed in section II.E.4. of the proposed rule. We proposed this policy would apply to all MIPS eligible clinicians participating in MIPS APMs (those that meet the criteria specified in section II.E.5.h.1. of the proposed rule) except in the case of a new MIPS APM for which the first APM performance period begins after the start of the corresponding MIPS performance period. In this instance, the participating MIPS eligible clinicians in the new MIPS APM would submit data to MIPS in the first MIPS performance period for the APM either as individual MIPS eligible clinicians or as a group using one of the MIPS data submission mechanisms for all four performance categories, and report to us using the APM scoring standard for subsequent MIPS performance period(s). Additionally, we anticipate that there might be MIPS APMs that would not be able to use the APM scoring standard (even though they met the criteria for the APM scoring standard and were treated as a MIPS APMs in the prior MIPS performance period) in their last year of operation because of technical or resource issues. For example, a MIPS APM in its final year may end earlier than the end of the MIPS performance period (proposed to be December 31). We might not have continuing resources dedicated or available to continue to support the MIPS APM activities under the APM scoring standard if the MIPS
The following is a summary of the comments we received regarding our proposal that the APM scoring standard performance period will be same as the MIPS performance period.
We are finalizing the APM scoring standard performance period to align with the MIPS performance period.
We believe that establishing an APM scoring standard under MIPS will allow APM Entities and their participating eligible clinicians to focus on the goals and objectives of the MIPS APM to improve quality and lower costs of care while avoiding potentially conflicting incentives and duplicative reporting that could occur as a result of having to submit separate or additional data to MIPS. The APM scoring standard we proposed is similar to group assessment under MIPS as described in section II.E.3.d. of the proposed rule, but would differ in one or more of the following ways: (1) Depending on the terms and conditions of the MIPS APM, an APM Entity could be comprised of a sole MIPS eligible clinician (for example, a physician practice with only one eligible clinician could be considered an APM Entity); (2) the APM Entity could include more than one unique TIN, as long as the MIPS eligible clinicians are identified as participants in the APM by their unique APM participant identifiers; (3) the composition of the APM Entity group could include APM participant identifiers with TIN/NPI combinations such that some MIPS eligible clinicians in a TIN are APM participants and other MIPS eligible clinicians in that same TIN are not APM participants. In contrast, assessment as a group under MIPS requires a group to be comprised of at least two MIPS eligible clinicians who have assigned their billing rights to a TIN. It also requires that all MIPS eligible clinicians in the group use the same TIN.
In addition to the APM Entity group composition being potentially different than that of a group as generally defined under MIPS, we proposed for the APM scoring standard that we would generate a MIPS final score by aggregating all scores for MIPS eligible clinicians in the APM Entity that is participating in the MIPS APM to the level of the APM Entity. As we explained in the proposed rule, we believe that aggregating the MIPS performance category scores at the level of the APM Entity is more meaningful to, and appropriate for, these MIPS eligible clinicians because they have elected to participate in a MIPS APM and collectively focus on care transformation activities to improve the quality of care.
Further, depending on the type of MIPS APM, we proposed that the weights assigned to the MIPS performance categories under the APM scoring standard for MIPS eligible clinicians who are participating in a MIPS APM may be different from the performance category weights for MIPs eligible clinicians not participating in a MIPS APM for the same performance period. For example, we proposed that under the APM scoring standard, the weight for the cost performance category will be zero and that for certain MIPS APMs, the weight for the quality performance category will be zero for the 2019 payment year. Where the weight for the performance category is zero, neither the APM Entity nor the MIPS eligible clinicians in the MIPS APM would need to report data in these categories, and we would redistribute the weights for the quality and cost performance categories to the improvement activities and advancing care information performance categories to maintain a total weight of 100 percent.
To implement certain elements of the APM scoring standard, we need to use the Shared Savings Program (section 1899 of the Act) and CMS Innovation Center (section 1115A of the Act) authorities to waive specific statutory provisions related to MIPS reporting and scoring. Section 1899(f) of the Act authorizes waivers of title XVIII requirements as may be necessary to carry out the Shared Savings Program, and section 1115A(d)(1) of Act authorizes waivers of title XVIII requirements as may be necessary solely for purposes of testing models under section 1115A of the Act. For each section in which we proposed scoring methodologies and waivers to enable the proposed approaches, we described how the use of waivers is necessary under the respective waiver authority standards. The underlying purpose of APMs is for CMS to pay for care in ways that are unique from FFS payment and to test new ways of measuring and assessing performance. If the data submission requirements and associated adjustments under MIPS are not aligned with APM-specific goals and incentives, the participants receive conflicting messages from us on priorities, which could create uncertainty and severely degrade our ability to evaluate the impact of any particular APM on the overall cost and quality of care. Therefore, we explained our belief that, for the reasons stated in section II.E.5.h. of the proposed rule certain waivers are necessary for testing and operating
In the proposed rule we noted that for at least the first performance year, we do not anticipate that any APMs other than those under sections 1115A or 1899 of the Act would meet the criteria to be MIPS APMs. In the event that we do anticipate other types of APMs (demonstrations under section 1866C of the Act or required by federal law) will become MIPS APMs for a future year, we will address MIPS scoring for eligible clinicians in those APMs in future rulemaking.
The following is a summary of the comments we received regarding our proposals to use the Shared Savings Program (section 1899 of the Act) and CMS Innovation Center (section 1115A of the Act) authorities to waive specific statutory provisions related to MIPS reporting and scoring to implement the APM Scoring Standard for MIPS APMs and to apply the MIPS final score at the APM Entity level.
The APM Entity final score is derived by aggregating the scores for each of the performance categories as applicable. For example, if the CPC+ model is determined to be a MIPS APM, participating MIPS eligible clinicians in CPC+ will not be evaluated in the cost and quality performance categories, which will have a zero weight for the first performance year. In this example, the final score will be calculated for MIPS eligible clinicians at the APM Entity level by adding the weighted advancing care information score and the assigned improvement activities score for the MIPS APM (see below for the final policies on the scoring for these performance categories). This same final score calculated at the APM Entity level will be applied to each MIPS eligible clinician TIN/NPI combination in the APM Entity as identified on the APM Entity's Participation List.
We are finalizing the proposal to use the Shared Savings Program and CMS Innovation Center authorities under sections 1899 and 1115A of the Act, respectively, to waive specific statutory requirements related to MIPS reporting and scoring in order to implement the APM scoring standard. We note that although we proposed to use our authority under section 1899(f) of the Act to waive these statutory requirements in order to implement the APM scoring standard for MIPS eligible clinicians participating in Shared Savings Program ACOs, we believe we could also use our authority under section 1899(b)(3)(D) of the Act to accomplish this result. Section 1899(b)(3)(D) of the Act allows us to incorporate reporting requirements under section 1848 of the Act into the reporting requirements for the Shared Savings Program, as we determine appropriate, and to use alternative criteria than would otherwise apply. Thus, we believe that section 1899(b)(3)(D) of the Act also provides authority to apply the APM scoring standard for MIPS eligible clinicians participating in a Shared Savings Program ACO rather than requiring these MIPS eligible clinicians to report individually or as a group using one of the MIPS data submission mechanisms.
We are also finalizing our proposal to score MIPS eligible clinicians in the MIPS APM at the APM Entity level. The final score calculated at the APM Entity level will be applied to each MIPS eligible clinician in the APM Entity group.
To ensure we have accurately captured performance data for all of the MIPS eligible clinicians that are participating in an APM, we proposed to establish and maintain an APM participant database that would include all of the MIPS eligible clinicians who are part of the APM Entity. We would establish this database to track participation in all APMs, in addition to specifically tracking participation in MIPS APMs and Advanced APMs. We proposed that each APM Entity be identified in the MIPS program by a unique APM Entity identifier, and we also proposed that the unique APM participant identifier for a MIPS eligible clinician would be a combination of four identifiers including: (1) APM identifier established by CMS (for example, AA); (2) APM Entity identifier established by CMS (for example, A1234); (3) the eligible clinician's billing TIN (for example, 123456789); and (4) NPI (for example, 1111111111). The use of the APM participant identifier will allow us to identify all MIPS eligible clinicians participating in an APM Entity, including instances in which the MIPS eligible clinicians use a billing TIN that is shared with MIPS eligible clinicians who are not participating in the APM Entity. In the proposed rule, we stated that we would plan to communicate to each APM Entity the MIPS eligible clinicians who are included in the APM Entity group in advance of the applicable MIPS data submission deadline for the MIPS performance period.
Under the Shared Savings Program, each ACO is formed by a collection of Medicare-enrolled TINs (ACO participants). Under our regulation at 42 CFR 425.118, all Medicare enrolled individuals and entities that have reassigned their rights to receive Medicare payment to the TIN of the ACO participant must agree to participate in the ACO and comply with the requirements of the Shared Savings Program. Because all providers and suppliers that bill through the TIN of an ACO participant are required to agree to participate in the ACO, all MIPS eligible clinicians that bill through the TIN of an ACO participant are considered to be participating in the ACO. For purposes of the APM scoring standard, the ACO
We recognize that there may be scenarios in which MIPS eligible clinicians may change TINs, use more than one TIN for billing Medicare, change their APM participation status, and/or change other practice affiliations during a performance period. Therefore, we proposed that only those MIPS eligible clinicians who are on the Participation List for the APM Entity in a MIPS APM on December 31 (the last day of the performance period) would be considered part of the APM Entity group for purposes of the APM scoring standard. Consequently, MIPS eligible clinicians who are not listed as participants of an APM Entity in a MIPS APM at the end of the performance period would need to submit data to MIPS through one of the MIPS data submission mechanisms and would have their performance assessed either as individual MIPS eligible clinicians or as a group for all four MIPS performance categories. For example, under the proposal, a MIPS eligible clinician who participates in the APM Entity on January 1, 2017, and leaves the APM Entity on June 15, 2017, would need to submit data to MIPS using one of the MIPS data submission mechanisms and would have their performance assessed either as an individual MIPS eligible clinician or as part of a group. This approach for defining the applicable group of MIPS eligible clinicians was consistent with our proposal for identifying eligible clinician groups for purposes of QP determinations outlined in section II.F.5.b. of the proposed rule; the group of eligible clinicians we use for purposes of a QP determination would be the same as that used for the APM scoring standard. This would be an annual process for each MIPS performance period.
The following is a summary of the comments we received regarding our proposals to establish an APM participant identifier, a CMS database to identify and track the APM participants, and the dates that we will use to determine if an MIPS APM eligible clinician will be included in the MIPS APM for purposes of MIPS reporting under the APM scoring standard.
We are finalizing the use of the proposed APM participant identifier to define the APM Entity group that is participating in a MIPS APM. The APM Participation List information will be stored in a database so that, among other uses, we can identify and include the appropriate MIPS eligible clinicians in an APM Entity group to which the APM scoring standard applies. We are revising our proposal to use December 31 as the date on which an eligible clinician must appear on the Participation List to be included in the APM Entity group for a MIPS APM. Instead of identifying MIPS eligible clinicians participating in a MIPS APM at a single point in time on December 31 of the performance year, we will review the MIPS APM Participation Lists on March 31, June 30 and August 31. All eligible clinicians who appear on an APM Entity's list for a MIPS APM on at least one of those three dates will be included in the APM Entity group for purposes of the APM scoring standard for the year. We describe the determination of the APM Entity group in full detail in section II.F.5. of this final rule with comment period.
As mentioned previously, section 1848(q)(3)(A) of the Act requires the Secretary to establish performance standards for the measures and activities under the following performance categories: (1) Quality; (2) cost; (3) improvement activities; and (4) advancing care information. We proposed at § 414.1370 to calculate one final score that is applied to the billing TIN/NPI combination of each MIPS eligible clinician in the APM Entity group. Therefore, each APM Entity group (for example, the MIPS eligible clinicians in a Shared Savings Program ACO or an Oncology Care Model practice) would receive a score for each of the four performance categories according to the proposals described in the proposed rule, and we would calculate one final score for the APM Entity group. The APM Entity group score would be applied to each MIPS eligible clinician in the group, and subsequently used to develop the MIPS payment adjustment that is applicable to each MIPS eligible clinician in the group. Thus, the final score for the APM Entity group and the participating MIPS eligible clinician score are the same. For
We explained in the proposed rule that we want to avoid situations in which different MIPS eligible clinicians in the same APM Entity group receive different MIPS scores. APM Entities have a goal of collective success under the terms of the APM, so having a variety of differing MIPS adjustments for eligible clinicians within that collective unit would undermine the intent behind the APM to test a departure from a purely FFS system based on independent clinician activity.
We proposed, for the first MIPS performance period, a specific scoring and reporting approach for the MIPS eligible clinicians participating in MIPS APMs, which would include the Shared Savings Program, the Next Generation ACO Model, and other APMs that meet the proposed criteria for a MIPS APM. In the proposed rule, we described the APM Entity data submission requirements and proposed a scoring approach for each of the MIPS performance categories for specific MIPS APMs (the Shared Savings Program, Next Generation ACO Model, and all other MIPS APMs).
The following is a summary of the comments we received regarding our proposal to calculate one final score per APM Entity group in a MIPS APM, and to apply that final score to each MIPS eligible clinician (identified by the billing TIN/NPI combination) in the APM Entity group and our proposal to give one-half of the maximum improvement activities score to any MIPS eligible clinicians who are on a list of participants and identified by the APM participant identifier, regardless of whether they participate in an Advanced APM, MIPS APM, or other APM.
Under specific circumstances, described below, in which a Shared Savings Program ACO fails to report quality under the Shared Savings Program requirements, participant TINs of such ACOs would be considered the APM Entity groups for purposes of the APM scoring standard. Even under this exception, those TIN groups would still be scored as a cohesive unit, with no individual final score variation within the TIN.
We are finalizing our proposal to calculate one final score at the APM Entity level that will be applied to the billing TIN/NPI combination of each MIPS eligible clinician in the APM Entity group. We are also finalizing our policy to give one-half of the maximum improvement activities score to eligible clinicians who are APM participants, with the clarification that we would extend such improvement activities scoring credit to any MIPS eligible clinicians identified by an APM participant identifier on a Participation List, an Affiliated Practitioners List, or other CMS-maintained list of participants at any time during the MIPS performance period.
In the event that a Shared Savings Program ACO does not report quality measures as required under the Shared Savings Program regulations, then scoring on all MIPS performance categories will be at the ACO participant TIN level, and the resulting TIN-level final score will be applied to each of its constituent TIN/NPI combinations. For purposes of both the Shared Savings Program quality performance requirement and the APM scoring standard, any “partial” reporting of quality measures through the CMS Web Interface that does not satisfy the quality reporting requirements under the Shared Savings Program will be considered a failure to report. We note that in this scenario, each ACO participant TIN would need to report quality data to MIPS according to MIPS group reporting requirements in order to avoid a score of zero for the quality performance category.
We believe that this exception for the Shared Savings Program recognizes the recommendations of several commenters that the APM scoring standard should apply at the TIN level and concerns that in some cases ACOs are not representative of the potentially widely-varying MIPS performance across ACO participant TINs. Although we maintain that the APM Entity-level scoring is generally appropriate to reflect the collective goals and responsibilities of the group, we believe that ACOs that fail to report quality as required under the Shared Savings Program do not necessarily represent the quality performance of their constituent TINs. Therefore, we believe it is appropriate in such cases to allow ACO participant TINs to avoid a score of zero in the quality performance category and to take responsibility for their own MIPS reporting and scoring independent of the ACO and other TINSs in the ACO. Further, this policy is generally consistent with similar policies that have been proposed for ACO participant TINs under PQRS and the Value Modifier program at (81 FR 46408-46409, 46426-46427).
Additionally, we recognize that there may be instances when an APM Entity's participation in the APM is terminated during the MIPS performance period. As we state in section II.F.5. of this final rule with comment period, we will not make the first assessment to determine whether a MIPS eligible clinician is on an APM Entity's Participation List until March 31 of the performance period. Therefore if an APM Entity group terminates its participation in the APM prior to March 31, the MIPS eligible clinicians would not be considered part of an APM Entity group for purposes of the APM scoring standard.
If an APM Entity's participation in the APM is terminated on or after March 31 of a performance period, the MIPS eligible clinicians in the APM Entity group would still be considered an APM Entity group in a MIPS APM for the year, and would report and be scored under the APM scoring standard.
We proposed that beginning with the first MIPS performance period Shared Savings Program ACOs would only need to submit their quality measures to CMS once using the CMS Web Interface through the same process that they use to report to the Shared Savings Program to report quality measures to MIPS. These data would be submitted once but used for both the Shared Savings Program and for MIPS. Shared Savings Program ACOs have used the CMS Web Interface for submitting their quality measures since the program's inception, making this a familiar data submission process. The Shared Savings Program quality measure data reported to the CMS Web Interface would be used by CMS to calculate the MIPS quality performance category score at the APM Entity group level. The Shared Savings Program quality performance data that is not submitted to the CMS Web Interface, for example the CAHPS survey and claims-based measures, would not be included in the MIPS APM quality performance category score. The MIPS quality performance category requirements and performance benchmarks for quality measures submitted via the CMS Web Interface would be used to determine the MIPS quality performance category score at the ACO level for the APM Entity group. We stated that we believe this would reduce the reporting burden for Shared Savings Program MIPS eligible clinicians by requiring quality measure data to be submitted only once and used for both programs.
In the proposed rule, we explained that we believe that no waivers are necessary to adopt this approach because the quality measures submitted via the CMS Web Interface under the Shared Savings Program are also MIPS quality measures and would be scored under MIPS performance standards. In the event that Shared Savings Program quality measures depart from MIPS measures in the future, we would address such changes including whether further waivers are necessary at such a time in future rulemaking.
The following is a summary of the comments we received regarding our proposal to have Shared Savings Program ACOs report quality measures to MIPS using the CMS Web Interface as
We are finalizing our proposal that a Shared Savings Program ACO's quality data reported to the CMS Web Interface as required by Shared Savings Program rules will also be used for purposes of scoring the MIPS quality performance category using MIPS performance benchmarks. We note that for purposes of the Shared Savings Program quality reporting requirement and the APM scoring standard, any “partial” reporting of quality measures through the CMS Web Interface that does not satisfy the requirements under the Shared Savings Program will be considered a failure to report, triggering the exception finalized above in which we will separately assess each ACO participant TIN under the APM scoring standard.
We proposed that for the first MIPS performance period, we would not assess MIPS eligible clinicians participating in the Shared Savings Program (the MIPS APM) under the cost performance category. We proposed this approach because: (1) Eligible clinicians participating in the Shared Savings Program are already subject to cost and utilization performance assessments under the APM; (2) the Shared Savings Program measures cost in terms of an objective, absolute total cost of care expenditure benchmark for a population of attributed beneficiaries, and participating ACOs may share savings and/or losses based on that standard, whereas the MIPS cost measures are relative measures such that clinicians are graded relative to their peers, and therefore different than assessing total cost of care for a population of attributed beneficiaries; and (3) the beneficiary attribution methodologies for measuring cost under the Shared Savings Program and MIPS differ, leading to an unpredictable degree of overlap (for eligible clinicians and for us) between the sets of beneficiaries for which eligible clinicians would be responsible that would vary based on unique APM Entity characteristics such as which and how many TINs comprise an ACO. We believe that with an APM Entity's finite resources for engaging in efforts to improve quality and lower costs for a specified beneficiary population, the population identified through an APM must take priority to ensure that the goals and program evaluation associated with the APM are as clear and free of confounding factors as possible. The potential for different, conflicting results across Shared Savings Program and MIPS assessments—due to the differences in attribution, the inclusion in MIPS of episode-based measures that do not
For example, Shared Savings Program ACOs are held accountable for expenditure benchmarks that reflect the total Medicare Parts A and B spending for their assigned beneficiaries, whereas many of the proposed MIPS cost measures focus on spending for particular episodes of care or clinical conditions. We consider it a programmatic necessity that the Shared Savings Program has the ability to structure its own measurement and payment for performance on total cost of care independent from other incentive programs such as the cost performance category under MIPS. Thus, we proposed to reduce the MIPS cost performance category weight to zero for all MIPS eligible clinicians in APM Entities participating in the Shared Savings Program.
Accordingly, under section 1899(f) of the Act, we proposed to waive—for MIPS eligible clinicians participating in the Shared Savings Program—the requirement under section 1848(q)(5)(E)(i)(II) of the Act that specifies the scoring weight for the cost performance category. With the proposed reduction of the cost performance category weight to zero, we believed it would be unnecessary to specify and use cost measures in determining the MIPS final score for these MIPS eligible clinicians. Therefore, under section 1899(f) of the Act, we proposed to waive—for MIPS eligible clinicians participating in the Shared Savings Program—the requirements under sections 1848(q)(2)(B)(ii) and 1848(q)(2)(A)(ii) of the Act to specify and use, respectively, cost measures in calculating the MIPS final score for such MIPS eligible clinicians.
Given the proposal to waive requirements under section 1848(q)(5)(E)(i)(II) of the Act in order to reduce the weight of the cost performance category to zero, we also needed to specify how that weight would be redistributed among the remaining performance categories in order to maintain a total weight of 100 percent. We proposed to redistribute the cost performance category weight to both the improvement activities and advancing care information performance categories as specified in Table 11 of this final rule with comment period. The MIPS cost performance category is proposed to have a weight of 10 percent for the first performance period. Because the MIPS quality performance category bears a relatively higher weight than the other three MIPS performance categories, and in accordance with section 1848(q)(5)(E)(i)(I) and (II) of the Act, the weight for this category will be reduced from 50 to 30 percent as of the 2021 MIPS payment period, we proposed to evenly redistribute the 10 percent cost performance category weight to the improvement activities and advancing care information performance categories so that the distribution does not change the relative weight of the quality performance category. Because the MIPS quality performance category weight is required under the statute to be reduced to 30 percent after the first 2 years of MIPS, we believe that increasing the quality performance category weight would be incongruous in light of the eventual balance of the weights set forth in the statute. The redistributed cost performance category weight of 10 percent would result in a 5 percentage point increase (from 15 to 20 percent) for the improvement activities performance category and a 5 percentage point increase (from 25 to 30 percent) for the advancing care information performance category. We invited comments on the proposed weights and specifically whether we should increase the MIPS quality performance category weight.
In the proposed rule we explained that as the MIPS cost performance category evolves over time, there might be greater potential for alignment and less potential duplication or conflict with MIPS cost measurement for MIPS eligible clinicians participating in APMs such as the Shared Savings Program. We will continue to monitor and consider how we might incorporate an assessment in the MIPS cost performance category into the APM scoring standard for MIPS eligible clinicians participating in the Shared Savings Program. We also understand that reducing the cost performance category weight to zero and redistributing the weight to the improvement activities and advancing care information performance categories could, to the extent that improvement activities and advancing care information scores are higher than the scores these MIPS eligible clinicians would have received under the cost performance category, would result in higher final scores on average for MIPS eligible clinicians participating in the Shared Savings Program. We solicited comment on the possibility of assigning a neutral score to the Shared Savings Program APM Entity groups for the cost performance category to moderate MIPS final scores for APM Entities participating in the Shared Savings Program. We also generally solicited comment on our proposed policy, and on whether and how we should incorporate the cost performance category into the APM scoring standard under MIPS for eligible clinicians participating in the Shared Savings Program for future years.
The following is a summary of the comments we received regarding our proposal to reduce the MIPS cost performance category weight to zero for APM Entity groups participating in the Shared Savings Program.
One commenter recommended that MIPS eligible clinicians in Shared Savings Program ACOs receive extra credit in the cost performance category if their ACO achieved expenditures below its benchmark. The commenter suggested that CMS consider having a sliding scale of cost category points awarded to MIPS eligible clinicians that participate in Shared Savings Program ACOs with benchmarks of less than $10,000 per beneficiary per year. One commenter proposed that CMS reward Shared Savings Program ACOs that score at or above the average on cost measures, and hold harmless Shared Savings Program ACOs scoring below average. One commenter was opposed to reducing the cost performance category weight to zero.
We are finalizing our proposal to reduce the cost performance category to zero percent for APM Entity groups in the Shared Savings Program and to evenly redistribute the 10 percent cost performance category weight to the improvement activities and advancing care information performance categories. We note that this policy may seem unnecessary given that the MIPS policy for the initial performance year reduces the cost performance category weight to zero for all MIPS eligible clinicians. However, the zero weight for the cost performance category for APM Entity groups in the Shared Savings Program will remain in place for subsequent years unless we modify it through future notice and comment rulemaking, whereas the zero weight given to the cost performance category under the generally applicable MIPS scoring standard is limited to the first performance period, will increase to 10 percent in the second performance period, and will increase to 30 percent in the third performance period. We believe that setting this foundation from the outset of the Quality Payment Program will contribute to consistency and minimize uncertainty for MIPS APM participants at least until such a time as we might identify a means to consider performance in the MIPS cost performance category that is congruent with cost evaluation under the Shared Savings Program.
We further note that although we proposed to use our authority under section 1899(f) of the Act to waive the requirement under section 1848(q)(5)(E)(i)(II) of the Act to specify the scoring weight for the cost performance category because it was necessary to waive this requirement in order to ensure that the Shared Savings Program retains the ability to structure its own measurement and payment for performance on total cost of care independent of other incentive programs, we believe we could also use our authority under section 1899(b)(3)(D) of the Act to accomplish this result. Section 1899(b)(3)(D) of the Act allows us to incorporate reporting requirements under section 1848 into the reporting requirements for the Shared Savings Program, as we determine appropriate, and to use alternative criteria than would otherwise apply. Thus, we believe that section 1899(b)(3)(D) of the Act also provides authority to reduce the weight of the cost performance category to zero percent for eligible clinicians participating in Shared Savings Program ACOs and to redistribute the 10 percent weight to the improvement categories and advancing care information categories.
We proposed that MIPS eligible clinicians participating in the Shared Savings Program would submit data for the MIPS improvement activities and advancing care information performance categories through their respective ACO participant billing TINs independent of the Shared Savings Program ACO. Under section 1848(q)(5)(C)(ii) of the Act, all ACO participant group billing TINs would receive a minimum of one half of the highest possible score for the improvement activities performance category. Additionally, under section 1848(q)(5)(C)(i) of the Act, any ACO participant TIN that is determined to be a patient-centered medical home or comparable specialty practice will receive the highest potential score for the improvement activities performance category. The improvement activities and advancing care information scores from all the ACO participant billing TINs would be averaged to a weighted mean MIPS APM Entity group level score. We proposed to use a weighted mean in computing the overall improvement activities and advancing care information quality performance category score to account for difference in the size of each TIN and to allow each TIN to contribute to the overall score based on its size. Then all MIPS eligible clinicians in the APM Entity group, as identified by their APM participant identifiers, would receive that APM Entity score. The weights used for each ACO participant billing TIN would be the number of MIPS eligible clinicians in that TIN. Because all providers and suppliers that bill through the TIN of an ACO participant are required to agree to participate in the ACO, all MIPS eligible clinicians that bill through the TIN of an ACO participant are considered to be participating in the ACO. Any Shared Savings Program ACO participant billing TIN that does not submit data for the MIPS improvement activities and/or advancing care information performance categories would contribute a score of zero for each performance category for which it does not report; and that score would be incorporated into the resulting weighted average score for the Shared Savings Program ACO. All MIPS eligible clinicians in the ACO (the APM Entity group) would receive the same score that is calculated at the ACO level (the APM Entity level).
In the proposed rule, we recognized that the Shared Savings Program eligible clinicians participate as a complete TIN because all of the eligible clinicians that have reassigned their Medicare billing rights to the TIN of an ACO participant must agree to participate in the Shared Savings Program. This is different from other APMs, which may include APM Entity groups with eligible clinicians who share a billing TIN with other eligible clinicians who do not participate in the APM Entity. We solicited comment on a possible alternative approach in which improvement activities and advancing care information performance category scores would be applied to all MIPS eligible clinicians at the individual billing TIN level, as opposed to aggregated to the ACO level, for Shared Savings Program participants. We also indicated that if MIPS APM scores were applied to each TIN in an ACO at the TIN level, we would also likely need to permit those TINs to make the Partial QP election, as discussed elsewhere in this final rule with comment, at the TIN level. We proposed that under the APM scoring standard, the ACO-level APM Entity group score would be applied to each participating MIPS eligible clinician to determine the MIPS payment adjustment. We explained that we believe calculating the score at the APM Entity level mirrors the way APM participants are assessed for their shared savings and other incentive payments in the APM, but we understand there may be reasons why a group TIN, particularly one that believes it would achieve a higher score than the weighted average APM Entity level score, would prefer to be scored in the improvement activities and advancing care information performance categories at the level of the group billing TIN rather than the ACO (APM Entity level).
We solicited comment as to whether Shared Savings Program ACO eligible clinicians should be scored at the ACO level or the group billing TIN level for the improvement activities and advancing care information performance categories.
The following is a summary of the comments we received regarding our proposals for how to score and weight the improvement activities and
For the Shared Savings Program we are finalizing the weights assigned to each of the MIPS performance categories as proposed for Shared Savings Program ACOs: Quality 50 percent; cost 0 percent; improvement activities 20 percent; and advancing care information 30 percent for purposes of the APM scoring standard. We are finalizing the proposal that for the advancing care information performance category, ACO participant TINs will report the category to MIPS, and the TIN scores will be aggregated and weighted in order to calculate one APM Entity score for the category. In the event a Shared Savings Program ACO fails to satisfy quality reporting requirements for measures reported through the CMS Web Interface, advancing care information group TIN scores will not be aggregated to the APM Entity level. Instead, each ACO participant TIN will be scored separately based on its TIN-level group reporting for the advancing care information performance category.
We are revising our proposal with respect to the scoring of the improvement activities performance category for the Shared Savings Program. We will assign an improvement activities score for the Shared Savings Program based on the improvement activities required under the Shared Savings Program. We consider all Shared Savings Program tracks together for purposes of assigning an improvement activities performance category score because the tracks all require the same activities of their participants. All APM Entity groups in the Shared Savings Program will receive that baseline improvement activities score. To develop the improvement activities score for the Shared Savings Program, we will compare the requirements of the Shared Savings Program with the list of improvement activities measures in section II.E.5.f. of
We proposed that beginning with the first MIPS performance period, Next Generation ACOs would only need to submit their quality measures to CMS once using the CMS Web Interface through the same process that they use to report to the Next Generation ACO Model. These data would be submitted once but used for purposes of both the Next Generation ACO Model and MIPS. Next Generation ACO Model ACOs have used the CMS Web Interface for submitting their quality measures since the model's inception and would most likely continue to use the CMS Web Interface as the submission method in future years. The Next Generation ACO Model quality measure data reported to the CMS Web Interface would be used by CMS to calculate the MIPS APM quality performance score. The MIPS quality performance category requirements and performance benchmarks for reporting quality measures via the CMS Web Interface would be used to determine the MIPS quality performance category score at the ACO level for the APM Entity group. The Next Generation ACO Model quality performance data that are not submitted to the CMS Web Interface, for example the CAHPS survey and claims-based measures, would not be included in the APM Entity group quality performance score. The APM Entity group quality performance category score would be calculated using only quality measure data submitted through the CMS Web Interface and scored using the MIPS benchmarks, whereas the quality reporting requirements and performance benchmarks calculated for the Next Generation ACO Model would continue to be used to assess the ACO under the APM-specific requirements. We stated in the proposed rule that we believe this approach would reduce the reporting burden for Next Generation ACO Model participants by requiring quality measure data to be submitted only once and used for both MIPS and the Next Generation ACO Model.
In the proposed rule, we indicated that we believe that no waivers are necessary here because the quality measures submitted via the CMS Web Interface under the Next Generation ACO Model are MIPS quality measures and would be scored under MIPS performance standards. In the event that Next Generation ACO Model quality measures depart from MIPS measures in the future, we stated that we would address such changes, including whether further waivers are necessary, at such a time in future rulemaking.
The following is a summary of the comments we received regarding our proposal to have Next Generation ACOs report quality measures to MIPS using the CMS Web Interface as they normally would under Next Generation ACO Model rules and our proposal for CMS to calculate the MIPS quality performance category score at the APM Entity group level based on the data reported to the CMS Web Interface and using the MIPS performance standards.
We are finalizing the scoring policy for the quality performance category for the Next Generation ACO Model as proposed. We will use Next Generation ACO Model quality measures submitted by the ACO to the CMS Web Interface and MIPS benchmarks to score quality for MIPS eligible clinicians in a Next Generation ACO at the APM Entity level. An ACO's failure to report quality as required by the Next Generation ACO Model will result in a quality score of zero for the APM Entity group.
We proposed that for the first MIPS performance period, we would not assess MIPS eligible clinicians in the Next Generation ACO Model participating in the MIPS APM under the cost performance category. We proposed this approach because: (1) MIPS eligible clinicians participating in the Next Generation ACO Model are already subject to cost and utilization performance assessments under the APM; (2) the Next Generation ACO Model measures cost in terms of an objective, absolute total cost of care expenditure benchmark for a population of attributed beneficiaries, and participating ACOs may share savings and/or losses based on that standard, whereas the MIPS cost measures are relative measures such that clinicians are graded relative to their peers and therefore different than assessing total cost of care for a population of attributed beneficiaries; and (3) the beneficiary attribution methodologies for measuring cost under the Next Generation ACO Model and MIPS differ, leading to an unpredictable degree of overlap (for eligible clinicians and for us) between the sets of beneficiaries for which eligible clinicians would be responsible that would vary based on unique APM Entity characteristics such as which and how many eligible clinicians comprise an ACO. We believe that with an APM Entity's finite resources for engaging in efforts to improve quality and lower costs for a specified beneficiary population, the population identified through the Next Generation ACO Model must take priority to ensure that the goals and model evaluation associated with the APM are as clear and free of confounding factors as possible. The potential for different, conflicting results across the Next Generation ACO Model and MIPS assessments—due to the differences in attribution, the inclusion in MIPS of episode-based measures that do not reflect the total cost of care, and the objective versus relative assessment factors listed above—creates uncertainty for eligible clinicians who are attempting to strategically transform their respective practices and succeed under the terms of the Next Generation ACO Model. For example, Next Generation ACOs are held accountable for expenditure benchmarks that reflect the total Medicare Parts A and B spending for their attributed beneficiaries, whereas many of the proposed MIPS cost measures focus on spending for particular episodes of care or clinical conditions. Therefore, we proposed to reduce the MIPS cost performance category weight to zero for all MIPS eligible clinicians participating in the Next Generation ACO Model. Accordingly, under section 1115A(d)(1) of the Act, we proposed to waive—for MIPS eligible clinicians participating in the Next Generation ACO Model—the requirement under section 1848(q)(5)(E)(i)(II) of the Act that specifies the scoring weight for the cost performance category. With the proposed reduction of the cost performance category weight to zero, we believe it would be unnecessary to specify and use cost measures in determining the MIPS final score for these MIPS eligible clinicians. Therefore, under section 1115A(d)(1) of the Act, we proposed to waive—for MIPS eligible clinicians participating in the Next Generation ACO Model—the requirements under sections 1848(q)(2)(B)(ii) and 1848(q)(2)(A)(ii) of the Act to specify and use, respectively, cost measures in calculating the MIPS final score for such eligible clinicians.
Given the proposal to waive requirements under section 1848(q)(5)(E) of the Act to reduce the weight of the cost performance category to zero, we must subsequently specify how that weight would be redistributed among the remaining performance categories to maintain a total weight of 100 percent. We proposed to redistribute the cost performance category weight to both the improvement activities and advancing care information performance categories as specified in Table 13 of the proposed rule. The MIPS cost performance category is proposed to have a weight of 10 percent. Because the MIPS quality performance category bears a relatively higher weight than the other three MIPS performance categories and the weight for this category will be reduced from 50 to 30 percent as of the 2021 payment year, we proposed to evenly redistribute the 10 percent cost weight to the improvement activities and advancing care information performance categories so that the distribution does not change the relative weight of the quality performance category in the opposite of the direction it will change in the future. Because the quality performance category weight is required under the statute to be reduced to 30 percent after the first 2 years of MIPS we believe that increasing the quality performance category weight is incongruous with the eventual balance of the weights set forth in the statute. The redistributed cost performance category weight of 10 percent would result in a 5 percentage point increase (from 15 to 20 percent) for the improvement activities performance category and a 5 percentage point increase (from 25 to 30 percent) for the advancing care information performance category. We invited comments on the proposed redistributed weights and specifically on whether we should also increase the MIPS quality performance category weight.
In the proposed rule, we explained that we understand that as the MIPS cost performance category evolves over time, there might be greater potential for alignment and less potential duplication or conflict with MIPS cost measurement for MIPS eligible clinicians participating in MIPS APMs such as the Next Generation ACO Model. We stated that we would continue to monitor and consider how we might incorporate an assessment in the MIPS cost performance category into the APM scoring standard for the Next Generation ACO Model. We also understand that reducing the cost weight to zero and redistributing the weight to the improvement activities and advancing care information performance categories could, to the extent that improvement activities and advancing care information performance category scores are higher than the scores MIPS eligible clinicians would have received under the cost performance category, result in higher final scores on average for MIPS eligible clinicians in APM Entity groups participating in the Next Generation ACO Model. We solicited comment on the possible alternative of assigning a neutral score to APM Entity groups participating in the Next Generation ACO model for the cost performance category in order to moderate APM Entity scores. We also generally sought comment on our proposed policy, and on whether and how we should incorporate the cost performance category into the APM scoring standard for MIPS eligible clinicians in APM Entity groups participating in the Next Generation ACO model for future years.
The following is a summary of the comments we received regarding our proposal to reduce the MIPS cost performance category weight to zero for APM Entity groups in the Next Generation ACO Model.
We are finalizing our proposal to reduce the cost performance category weight to zero for MIPS eligible clinicians in APM Entity groups participating in the Next Generation ACO Model and to evenly redistribute the 10 percent cost weight to the improvement activities and advancing care information performance categories without changes.
We proposed that all MIPS eligible clinicians participating in the Next Generation ACO Model would submit data for the improvement activities and advancing care information performance categories. MIPS eligible clinicians participating in the Next Generation ACO Model may bill through a TIN that includes other MIPS eligible clinicians not participating in the APM. Therefore for both the improvement activities and advancing care information performance categories, we proposed that MIPS eligible clinicians participating in the Next Generation ACO Model would submit individual level data to MIPS and not group level data.
For both the improvement activities and advancing care information performance categories, the scores from all of the individual MIPS eligible clinicians in the APM Entity group would be aggregated to the APM Entity level and averaged for a mean score. Any individual MIPS eligible clinicians that do not report for purposes of the improvement activities performance category or the advancing care information performance category would contribute a score of zero for that performance category in the calculation of the APM Entity score. All MIPS eligible clinicians in the APM Entity group would receive the same APM Entity score.
Because the MIPS quality performance category bears a relatively higher weight than the other three MIPS performance categories, we proposed to evenly redistribute the 10 percent cost performance category weight to the improvement activities and advancing care information performance categories. Section 1848(q)(5)(C)(i) of the Act requires that MIPS eligible clinicians who are in a practice that is certified as a patient-centered medical home or comparable specialty practice, as determined by the Secretary, for a performance period shall be given the highest potential score for the improvement activities performance category. Accordingly, a MIPS eligible clinician participating in an APM Entity that meets the definition of a patient-centered medical home or comparable specialty practice will receive the highest potential improvement activities score. Additionally, section 1848(q)(5)(C)(ii) of the Act requires that MIPS eligible clinicians participating in APMs that are not patient-centered medical homes for a performance period shall earn a minimum score of one-half of the highest potential score for improvement activities.
For the APM scoring standard for the first MIPS performance period, we proposed to weight the improvement activities and advancing care information performance categories for the Next Generation ACO Model in the same way that we proposed to weight those categories for the Shared Savings Program: 20 percent and 30 percent for improvement activities and advancing care information, respectively. We solicited comment on our proposals for reporting and scoring the improvement activities and advancing care information performance categories under the APM scoring standard. In particular, we solicited comment on the appropriate weight distributions in the first performance year.
The following is a summary of the comments we received regarding our proposals to score and weight the improvement activities and advancing care information performance categories for APM Entity groups in the Next Generation ACO under the APM scoring standard.
Regarding the advancing care information performance category, we do not believe that there is a compelling reason to exclude assessment in this performance category from the APM scoring standard in the same way that we are reducing the weight of the cost performance category. We do not see advancing care information measurement as duplicative or in conflict with Next Generation ACO Model goals and requirements. Participation in the Next Generation ACO Model is aligned with many MIPS improvement activities measures. This is why we are finalizing a policy that further reduces MIPS reporting burdens for Next Generation ACO Model participants and recognizes the similarities between MIPS improvement activities and the requirements of participating in the Next Generation ACO Model.
In response to comments, we are revising our proposal with respect to the scoring of the improvement activities performance category for the Next Generation ACO Model. CMS will assign all APM Entity groups in the Next Generation ACO Model the same improvement activities score based on the improvement activities required by the Next Generation ACO Model. To develop the improvement activities score assigned to all APM Entity groups in the Next Generation ACO Model, CMS will compare the requirements under the Next Generation ACO Model with the list of improvement activities measures in section II.E.5.f. of this final rule with comment period and score those measures in the same manner that they are otherwise scored for MIPS eligible clinicians according to section II.E.5.f. of this final rule with comment period. Thus, points assigned for participation in the Next Generation ACO Model will relate to documented requirements under the terms of the Next Generation ACO Model. We will publish the assigned improvement activities performance category score for the Next Generation ACO Model, based on the APM's improvement activity requirements, prior to the start of the performance period. In the event that the assigned score does not represent the maximum improvement activities score, APM Entities will have the opportunity to report additional improvement activities that would be applied to the baseline APM Entity group score. In the event that the baseline assigned score represents the maximum improvement activities score, APM Entities will not need to report additional improvement activities.
In order to further reduce reporting burden and align with the generally applicable MIPS group reporting option, we are revising the advancing care information scoring policy for the Next Generation ACO Model. A MIPS eligible clinician may receive a score for the advancing care information performance category either through individual reporting or through group reporting based on a TIN according to the generally applicable MIPS reporting and scoring rules for the advancing care information performance category, described in section II.E.5.g of this final rule with comment period. We will attribute one advancing care information score to each MIPS eligible clinician in an APM Entity by looking at both individual and group data submitted for a MIPS eligible clinician and using the highest reported score. Thus, instead of only using individual scores to derive an APM Entity-level advancing care information score as proposed, we will use the highest score attributable to each MIPS eligible clinician in an APM Entity group in order to determine the APM Entity group score based on the average of the highest scores for all MIPS eligible clinicians in the APM Entity group.
Like the proposed policy, each MIPS eligible clinician in the APM Entity group will receive one score, weighted equally with that of the other clinicians in the group, and CMS will calculate a single APM Entity-level advancing care information performance category score. Also like the proposed policy, for a MIPS eligible clinician who has no advancing care information performance category score—if the individual's TIN did not report as a group and the individual did not report—that MIPS eligible clinician will contribute a score of zero to the aggregate APM Entity group score.
In summary, we will attribute one advancing care information performance category score to each MIPS eligible clinician in an APM Entity group, which will be averaged with the scores of all other MIPS eligible clinicians in the APM Entity group to derive a single APM Entity score. In attributing a score to an individual, we will use the highest score attributable to the TIN/NPI combination of a MIPS eligible clinician. Finally, if there is no group or individual score, we will attribute a zero to the MIPS eligible clinician, which will be included in the aggregate APM Entity score.
We have revised this policy for the advancing care information performance category for Next Generation ACOs under the APM scoring standard because we recognize that individual reporting in the advancing care information performance category for all MIPS eligible clinicians in an APM Entity group may be more burdensome than allowing some degree of group reporting where applicable, and we believe that requiring individual reporting on advancing care information in the Next Generation ACO Model context will not supply a meaningfully greater amount of information regarding the use of EHR technology as prescribed by the advancing care information performance category. We believe that this revised policy maintains the alignment with the generally applicable MIPS reporting and scoring requirements under the advancing care information performance category while responding to commenters' desires for reduced reporting requirements for MIPS APM participants. Therefore, we believe that the revised policy, relative to the proposed policy, has the potential to substantially reduce reporting burden with little to no reduction in our ability to accurately evaluate the adoption and use of EHR technology. We also believe this final policy balances the simplicity of TIN-level group reporting, which can reduce burden, with the flexibility needed to address partial TIN scenarios common among Next Generation ACOs in which a TIN may have some MIPS eligible clinicians participating in the ACO and some MIPS eligible clinicians not in the ACO. Table 12 summarizes the final APM scoring standard rules for the Next Generation ACO Model.
For MIPS APMs other than the Shared Savings Program and the Next Generation ACO Model, we proposed that eligible clinicians or APM Entities would submit APM quality measures under their respective MIPS APM as usual, and those eligible clinicians or APM Entities would not also be required to submit quality information under MIPS for the first performance period. Current MIPS APMs have requirements regarding the number of quality measures, measure specifications, as well as the measure reporting method(s) and frequency of reporting, and have an established mechanism for submission of these measures to us. We believe there are operational considerations and constraints that would prevent us from being able to use the quality measure data from some MIPS APMs for the purpose of satisfying the MIPS data submission requirements for the quality performance category in the first performance period. For example, some current APMs use a quality measure data collection system or vehicle that is separate and distinct from the MIPS systems. We do not believe there is sufficient time to adequately implement changes to the current APM quality measure data collection timelines and infrastructure to conduct a smooth hand-off to the MIPS system that would enable use of APM quality measure data to satisfy the MIPS quality performance category requirements in the first MIPS performance period. As we have noted, we are concerned about subjecting MIPS eligible clinicians who participate in MIPS APMs to multiple performance assessments—under MIPS and under the APMs—that are not necessarily aligned and that could potentially undermine the validity of testing or performance evaluation under the APM. As stated in the proposed rule, our goal is to reduce MIPS eligible clinician reporting burden by not requiring APM participants to report quality data twice to us, and to avoid misaligned performance incentives. Therefore, we proposed that, for the first MIPS performance period only, for MIPS eligible clinicians participating in APM Entity groups in MIPS APMs (other than the Shared Savings Program or the Next Generation ACO Model), we would reduce the weight for the quality performance category to zero. As we explained in the proposed rule, we believe it is necessary to do this because we require additional time to make adjustments in systems and processes related to the submission and collection of APM quality measures to align APM quality measures with MIPS and ensure APM quality measure data can be submitted in a time and manner sufficient for use in assessing quality performance under MIPS and under the APM. Additionally, due to the implementation of a new program that does not account for non-MIPS measures sets, the operational complexity of connecting APM performance to valid MIPS quality performance category scores in the necessary timeframe, as well as the uncertainty of the validity and equity of scoring results could unintentionally undermine the quality performance assessments in MIPS APMs. Finally, for purposes of performing valid evaluations of MIPS APMs, we must reduce the number of confounding factors to the extent feasible, which, in this case, would include reporting and assessment on non-APM quality measures. Thus, we proposed to waive certain requirements of section 1848(q) of the Act for the first MIPS performance year to avoid risking adverse operational or program evaluation consequences for MIPS APMs while we work toward incorporating MIPS APM quality measures into MIPS scoring for future MIPS performance periods.
Accordingly, under section 1115A(d)(1) of the Act, we proposed to waive—for MIPS eligible clinicians participating in MIPS APMs other than the Shared Savings Program or the Next Generation ACO Model—the requirement under section 1848(q)(5)(E)(i)(I) of the Act that specifies the scoring weight for the quality performance category. With the proposed reduction of the quality performance category weight to zero, we believe it would be unnecessary to establish an annual final list of quality measures as required under section 1848(q)(2)(D) of the Act, or to specify
We anticipated that beginning in the second MIPS performance period, the APM quality measure data submitted to us during the MIPS performance period would be used to derive a MIPS quality performance score for APM Entities in all APMs that meet criteria for application of the APM scoring standard. We also anticipated that it may be necessary to propose policies and waivers of different requirements of the statute—such as one for section 1848(q)(2)(D) of the Act, to enable the use of non-MIPS quality measures in the quality performance category score—through future rulemaking. We indicated that we expect that by the second MIPS performance period we will have had sufficient time to resolve operational constraints related to use of separate quality measure systems and to adjust quality measure data submission timelines. Therefore, beginning with the second MIPS performance period, we anticipated that through use of the waiver authority under section 1115A(d)(1) of the Act, the quality measure data for APM Entities for which the APM scoring standard applies would be used for calculation of a MIPS quality performance score in a manner specified in future rulemaking. We solicited comment on this transitional approach to use of APM quality measures for the MIPS quality performance category for purposes of the APM scoring standard under MIPS in future years.
The following is a summary of the comments we received regarding our proposal to, for the first MIPS performance period, reweight the quality performance category to zero for APM Entity groups in MIPS APMs other than the Shared Savings Program or the Next Generation ACO Model.
We are finalizing as proposed the policy to reweight the MIPS quality performance category to zero percent for APM Entity groups in MIPS APMs other than the Shared Savings Program or the Next Generation ACO Model for the first performance year.
For the first MIPS performance period, we proposed that, for MIPS eligible clinicians participating in MIPS APMs other than the Shared Savings Program or the Next Generation ACO Model, to reduce the weight of the cost performance category to zero. We proposed this approach because: (1) APM Entity groups are already subject to cost and utilization performance assessments under MIPS APMs; (2) MIPS APMs usually measure cost in terms of total cost of care, which is a broader accountability standard that inherently encompasses the purpose of the claims-based measures that have relatively narrow clinical scopes, and MIPS APMs that do not measure cost in terms of total cost of care may depart entirely from MIPS measures; and (3) the beneficiary attribution methodologies differ for measuring cost under APMs and MIPS, leading to an unpredictable degree of overlap (for eligible clinicians and for CMS) between the sets of beneficiaries for which eligible clinicians would be responsible that would vary based on unique APM Entity characteristics such as which and how many eligible clinicians comprise an APM Entity. We believe that with an APM Entity's finite resources for engaging in efforts to improve quality and lower costs for a specified beneficiary population, the population identified through an APM must take priority to ensure that the goals and model evaluation associated with the APM are as clear and free of confounding factors as possible. The potential for different, conflicting results across APM and MIPS assessments creates uncertainty for MIPS eligible clinicians who are attempting to strategically transform their respective practices and succeed under the terms of an APM. Accordingly, under section 1115A(d)(1) of the Act, we proposed to waive—for MIPS eligible clinicians participating in MIPS APMs other than the Shared Savings Program or the Next Generation ACO Model—the requirement under section 1848(q)(5)(E)(i)(II) of the Act that specifies the scoring weight for the cost performance category.
With the proposed reduction of the cost performance category weight to zero, we believed it would be unnecessary to specify and use cost measures in determining the MIPS final score for these MIPS eligible clinicians. Therefore, under section 1115A(d)(1) of the Act, we proposed to waive—for MIPS eligible clinicians participating in MIPS APMs other than the Shared Savings Program or the Next Generation ACO Model—the requirements under section under sections 1848(q)(2)(B)(ii) and 1848(q)(2)(A)(ii) of the Act to specify and use, respectively, cost measures in calculating the MIPS final score for such eligible clinicians.
Given the proposal to waive requirements of section 1848(q) of the Act to reduce the weight of the quality and cost performance categories to zero, we also needed to specify how those weights would be redistributed among the remaining improvement activities and advancing care information categories in order to maintain a total weight of 100 percent. We proposed to redistribute the quality and the cost performance category weights as specified in Table 14 of the proposed rule.
We understand that as the cost performance category evolves, the rationale we discussed in the proposed rule for establishing a weight of zero for this performance category might not be applicable in future years. We solicited comment on whether and how we should incorporate the cost performance category into the APM scoring standard
The following is a summary of the comments we received regarding our proposal to establish a MIPS cost performance category weight of zero for all MIPS eligible clinicians in APM Entities participating in the MIPS APMs other than the Shared Savings Program and the Next Generation ACO model.
We are finalizing the proposal to reduce the cost performance category weight to zero percent for APM Entity groups in MIPS APMs other than the Shared Savings Program or the Next Generation ACO Model.
We proposed that all MIPS eligible clinicians participating in a MIPS APM other than the Shared Savings Program or the Next Generation ACO Model would submit data for the improvement activities and advancing care information performance categories as individual MIPS eligible clinicians. MIPS eligible clinicians in these other APMs may bill through a TIN that includes MIPs eligible clinicians that do not participate in the APM. Therefore for both the improvement activities and the advancing care information performance categories, we proposed that these MIPS eligible clinicians submit individual level data to MIPS and not group level data. For both the improvement activities and advancing care information performance categories, the scores from all of the individual MIPS eligible clinicians in the APM Entity group would be aggregated to the APM Entity level and averaged for a mean score. Any individual MIPS eligible clinicians that do not submit data for the improvement activities performance category or the advancing care information performance category would contribute a score of zero for that performance category in the calculation of the APM Entity score. All MIPS eligible clinicians in the APM Entity group would receive the same APM Entity group score.
Section 1848(q)(5)(C)(i) of the Act requires that MIPS eligible clinicians who are in a practice that is certified as a patient-centered medical home or comparable specialty practice, as determined by the Secretary, for a performance period shall be given the highest potential score for the improvement activities performance category. Accordingly, a MIPS eligible clinician in an APM Entity group that meets the definition of a patient-centered medical home or comparable specialty practice will receive the highest potential score. Additionally, section 1848(q)(5)(C)(ii) of the Act requires that MIPS eligible clinicians participating in APMs that are not patient-centered medical homes for a performance period shall earn a minimum score of one-half of the highest potential score for improvement activities. We acknowledged that using this increased weight for improvement activities may make it easier in the first performance period for eligible clinicians in a MIPS APM to attain a higher MIPS score. We do not have historical data to assess the range of scores under improvement activities because this is the first time such activities are being assessed in such a manner.
For the advancing care information performance category, we explained our belief that MIPS eligible clinicians participating in MIPS APMs would be using certified health IT and other health information technology to coordinate care and deliver better care to their patients. Most MIPS APMs encourage participants to use health IT to perform population management, monitor their own quality improvement activities and, better coordinate care for their patients in a way that aligns with the goals of the advancing care information performance category. In the proposed rule, we indicated that we want to ensure that where we proposed reductions in weights for other MIPS performance categories, such weights are appropriately redistributed to the advancing care information performance category.
Therefore, for the first MIPS performance period, we proposed that the weights for the improvement activities and advancing care information performance categories would be 25 percent and 75 percent, respectively. We solicited comment on our proposals for reporting and scoring the improvement activities and advancing care information performance categories under the APM scoring standard. In particular, we solicited comment on the appropriate weight distributions in the first performance year and subsequent years when we anticipate incorporating assessment in the quality performance category for all MIPS eligible clinicians participating in MIPS APMs.
The following is a summary of the comments we received regarding our proposals to score and weight the improvement activities and advancing care information performance categories for MIPS eligible clinicians participating in APM Entity groups in MIPS APMs other than the Shared Savings Program and the Next Generation ACO Model under the APM scoring standard.
We agree with commenters that reporting in the improvement activities performance category could be more efficient if done by an APM Entity on behalf of the APM Entity group. In order to further reduce reporting burden on all parties and to better recognize improvement activities work performed through participation in MIPS APMs, we are modifying our proposal with respect to scoring for the improvement activities performance category under the MIPS APM scoring standard. As described above, we will assign an improvement activities performance category score at the MIPS APM level based on the requirements of participating in the particular MIPS APM. The baseline score will be applied to each APM Entity group in the MIPS APM. In the event that the assigned score is less than the maximum score, we would allow the APM Entity to report additional activities to add points to the APM Entity group score. With regards to the comment suggesting scoring improvement activities at the individual level, we believe that reporting and scoring improvement activities at the APM Entity level support the goals of APM participation, which focus on collective responsibility for the cost and quality of care for beneficiaries. Similarly, we agree with the comments pointing out that eligible clinicians participating in MIPS APMs are actively engaged in improvement activities by virtue of participating in the APM.
We are revising the proposed improvement activities scoring policy for MIPS APMs other than the Shared Savings Program or the Next Generation ACO Model. CMS will assign a score for the improvement activities performance category to each MIPS APM, and that score will be applied to each APM Entity group in the MIPS APM. To develop the improvement activities score for a MIPS APM, CMS will compare the requirements of the MIPS APM with the list of improvement activities measures in section II.E.5.f. of this final rule with comment period and score those measures in the same manner that they are otherwise scored for MIPS eligible clinicians according to section II.E.5.f. of this final rule with comment period. Thus, points assigned to an APM Entity group in a MIPS APM under the improvement activities performance category will relate to
In order to further reduce reporting burden and align with the generally applicable MIPS group reporting option, we are also revising the proposed advancing care information scoring policy for MIPS APMs other than the Shared Savings Program and the Next Generation ACO Model.
A MIPS eligible clinician may receive a score for the advancing care information performance category either through individual reporting or through group reporting based on a TIN according to the generally applicable MIPS reporting and scoring rules for the advancing care information performance category, described in section II.E.5.g. of this final rule with comment period. We will attribute one score to each MIPS eligible clinician in an APM Entity group by looking for both individual and group data submitted for a MIPS eligible clinician and using the highest score. Thus, instead of only using individual scores to derive an APM Entity-level advancing care information score as proposed, we will use the highest score attributable to each MIPS eligible clinician in an APM Entity group in order to create the APM Entity group score based on the average of the highest scores for all MIPS eligible clinicians in the APM Entity group.
Like the proposed policy, each MIPS eligible clinician in the APM Entity group will receive one score, weighted equally with that of the other clinicians in the group, and we will calculate a single APM Entity-level advancing care information score. Also like the proposed policy, for a MIPS eligible clinician who has no advancing care information score attributable to the individual—the individual's TIN did not report as a group and the individual did not report—that MIPS eligible clinician will contribute a score of zero to the aggregate APM Entity group score.
In summary, we will attribute one advancing care information score to each MIPS eligible clinician in an APM Entity group, which will be averaged with the scores of all other MIPS eligible clinicians in the APM Entity group to derive a single APM Entity score. In attributing a score to an individual, we will use the highest score attributable to the TIN/NPI combination of a MIPS eligible clinician. Finally, if there is no group or individual score, we will attribute a zero to the MIPS eligible clinician, which will be included in the aggregate APM Entity score.
We have revised the proposed policy for the advancing care information performance category for MIPS APM participants under the APM scoring standard because we recognize that individual reporting in the advancing care information performance category for all MIPS eligible clinicians in an APM Entity group may be more burdensome than allowing some degree of group reporting where applicable, and we believe that requiring individual reporting on advancing care information in the MIPS APM context will not supply a meaningfully greater amount of information regarding the use of EHR technology as prescribed by the advancing care information performance category. We believe that this revised policy maintains the alignment with the generally applicable MIPS reporting and scoring requirements under the advancing care information performance category while responding to commenters' desires for reduced reporting requirements for MIPS APM participants. Therefore, we believe that the revised policy, relative to the proposed policy, has the potential to substantially reduce reporting burden with little to no reduction in our ability to accurately evaluate the adoption and use of EHR technology. We also believe this final policy balances the simplicity of TIN-level group reporting, which can reduce burden, with the flexibility needed to address partial TIN scenarios common among APM Entities in MIPS APMs in which a TIN may have some MIPS eligible clinicians participating in the APM Entity and some MIPS eligible clinicians not in the APM Entity. Table 13 summarizes the finalized APM scoring standard rules for MIPS APMs other than the Shared Savings Program and Next Generation ACO Model.
Presently, we require APM Entities in MIPS APMs to either use the CMS Web Interface or another data submission mechanism for submitting data on the quality measures for purposes of the APM. We are not currently proposing to change the method used by APM Entities to submit their quality measure data to CMS. Therefore, we expect that APM Entities like the Shared Savings Program ACOs will continue to submit their data on quality measures using the CMS Web Interface data submission mechanism. Similarly, in the event that the Comprehensive ESRD Care (CEC) Initiative is determined to be a MIPS APM, APM Entities in the CEC would continue to submit their quality measures to CMS using the Quality Measures Assessment Tool (QMAT) for purposes of the CEC quality performance assessment under the APM. We proposed that all MIPS eligible clinicians in APM Entities participating in MIPS APMs would be required to use one of the proposed MIPS data submission mechanisms to submit data for the advancing care information performance category.
The following is a summary of the comments we received regarding the method used by APM Entities to submit quality data for purposes of MIPS.
We are finalizing without changes our proposal regarding APM Entity data submission for the quality performance category in all MIPS APMs and the advancing care information performance category in the Shared Savings Program. APM Entity groups will not submit data for the improvement activities performance category unless the improvement activities performance category score we assign at the MIPS APM level is less than the maximum score. In this instance, the APM Entities in the MIPS APM would use one of the MIPS data submission mechanisms if they opt to report additional improvement activities in order to increase their score for the improvement activities performance category. MIPS eligible clinicians in APM Entity groups participating in MIPS APMs other than the Shared Savings Program may report advancing care information performance category to MIPS using a MIPS data submission mechanism for either group reporting at the TIN level or individual reporting. Table 14 describes data submission methods for the MIPS performance categories under the APM scoring standard.
For the first MIPS performance feedback specified under section 1848(q)(12) of the Act to be published by July 1, 2017, we proposed that all MIPS eligible clinicians participating in MIPS APMs would receive the same historical information prepared for all MIPS eligible clinicians except the report would indicate that the historical information provided to such MIPS eligible clinicians is for informational purposes only. MIPS eligible clinicians participating in APMs have been evaluated for performance only under the APM. Thus, historical information may not be representative of the scores that these MIPS eligible clinicians would receive under MIPS.
For MIPS eligible clinicians participating in MIPS APMs, we proposed that the MIPS performance feedback would consist only of the scores applicable to the APM Entity group for the specific MIPS performance period. For example, the MIPS eligible clinicians participating in the Shared Savings Program and Next Generation ACO Model would receive performance feedback for the quality, improvement activities, and advancing care information performance categories for the 2017 performance period. Because these MIPS eligible clinicians would not be assessed for the cost performance category, information on MIPS performance scores for the cost performance category would not be applicable to these MIPS eligible clinicians.
We also proposed that, for the Shared Savings Program, the performance feedback would be available to the eligible clinicians participating in the Shared Savings Program at the group billing TIN level. For the Next Generation ACO Model we proposed that the performance feedback would be available to all MIPS eligible clinicians participating in the MIPS APM Entity.
We proposed that in the first MIPS performance period, the MIPS eligible clinicians participating in MIPS APMs other than the Shared Savings Program or the Next Generation ACO Model would receive performance feedback for the improvement activities and advancing care information performance categories only, as they would not be assessed under the quality or cost performance categories. The information such as MIPS measure score comparisons for the quality and cost performance categories would not be applicable to these MIPS eligible clinicians because no such comparative data would exist. We proposed the performance feedback for MIPS eligible clinicians participating in these other APMs would be available for each MIPS eligible clinician that submitted MIPS data for these performance categories under their respective APM Entities. We invited comment on these proposals.
The following is a summary of the comments we received regarding our proposals to provide the same historical information as those participating in MIPS, provide feedback on scores for applicable performance categories to the APM Entity group for the specific MIPS performance period, and provide feedback for those participating in the Shared Savings Program at the group TIN level and feedback for those participating in the Next Generation ACO Model and all other MIPS APMs at the individual level.
We are revising the proposed policy in order to maintain alignment with the generally applicable MIPS performance feedback policies. As noted in section II.E.8.a. of this final rule with comment period, the September 2016 QRUR will be used to satisfy the requirement under section 1848(q)(12)(A)(i) of the Act to provide MIPS eligible clinicians performance feedback on the quality and cost performance categories beginning July 1, 2017. We are finalizing a policy that all MIPS eligible clinicians scored under the APM scoring standard will also receive this performance feedback to the extent applicable, unless they did not have data included in the September 2016 QRUR. MIPS eligible clinicians without data included in the September 2016 QRUR will not receive performance feedback until CMS is able to use data acquired through the Quality Payment Program for performance feedback.
By incentivizing quality and value for all MIPS eligible clinicians, MIPS creates a new mechanism for calculating MIPS eligible clinician payments. To implement this vision, we proposed a scoring methodology that allows for accountability and alignment across the performance categories and minimizes burden on MIPS eligible clinicians. Further, we proposed a scoring methodology that is meaningful, understandable and flexible for all MIPS eligible clinicians. Our proposed methodology would allow for multiple pathways to success with flexibility for the variety of practice types and reporting options. First, we proposed multiple ways that MIPS eligible clinicians may submit data to MIPS for the quality performance category. Second, we provided greater flexibility in the reporting requirements and scoring for MIPS. Third, we proposed that bonus points would be available for reporting high priority measures and electronic reporting of quality data. Recognizing that MIPS is a new program, we also outlined proposals which we believed are operationally feasible for us to implement in the transition year, while maintaining our longer-term vision.
Section 1848(q) of the Act requires the Secretary to: (1) Develop a methodology for assessing the total performance of each MIPS eligible clinician according to performance standards for a performance period for a year; (2) using the methodology, provide a final score for each MIPS eligible clinician for each performance period; and (3) use the final score of the MIPS eligible clinician for a performance period to determine and apply a MIPS payment adjustment factor (and, as applicable, an additional MIPS payment adjustment factor) to the MIPS eligible clinician for the MIPS payment year. In section II.E.5 of the proposed rule (81 FR 28181), we proposed the measures and activities for each of the four MIPS performance categories: Quality, cost, improvement activities, and advancing care information. This section of the final rule with comment period discusses our proposals of the performance standards for the measures and activities for each of the four performance categories under section 1848(q)(3) of the Act, the methodology for determining a score for each of the four performance categories (referred to as a “performance category score”), and the methodology for determining a final score under section 1848(q)(5) of the Act based on the scores determined for each of the four performance categories. We proposed to
As noted in section II.E.2 of the proposed rule (81 FR 28176), we proposed to use multiple identifiers to allow MIPS eligible clinicians to be measured as individuals, or collectively as part of a group or an APM Entity group (an APM Entity participating in a MIPS APM). Further, in section II.E.5.a.(2) of the proposed rule (81 FR 28182), we proposed that data for all four MIPS performance categories would be submitted using the same identifier (either individual or group) and that the final score would be calculated using the same identifier. Section II.E.5.h of the final rule with comment period describes our policies in the event that an APM Entity scored through the APM scoring standard fails reporting. The scoring proposals in section II.E.6 of the proposed rule (81 FR 28247), would be applied in the same manner for either individual submissions, proposed as TIN/NPI, or for the group submissions using the TIN identifier. Unless otherwise noted, for purposes of this section on scoring, the term “MIPS eligible clinician” will refer to clinicians that are reporting and are scored at either the individual or group level, but will not refer to clinicians participating in an APM Entity scored through the APM scoring standard.
Comments related to APM Entity group reporting and scoring for MIPS eligible clinicians participating in MIPS APMs are summarized in section II.E.5.h of this final rule with comment period. All eligible clinicians that participate in APMs are considered MIPS eligible clinicians unless and until they are determined to be either QPs or Partial QPs who elect not to report under MIPS, and are excluded from MIPS, or unless another MIPS exclusion applies. We finalize at § 414.1380(d) that MIPS eligible clinicians in APM Entities that are subject to the APM scoring standard are scored using the methodology under § 414.1370, as described in II.E.5.h of this final rule with comment period.
MIPS eligible clinicians who participate in APMs that are not MIPS APMs as defined in section II.E.5.h of the proposed rule (81 FR 28234) would report to MIPS as an individual MIPS eligible clinician or group. Unless otherwise specified, the proposals in section II.E.6.a of the proposed rule (81 FR 28247) that relate to reporting and scoring of measures and activities do not affect the APM scoring standard.
Our rationale for our scoring methodology is grounded in the understanding that the MIPS scoring system has many components and numerous moving parts. Thus, we believe it is necessary to set up key parameters around scoring, including requiring MIPS eligible clinicians to report at the individual or group level across all performance categories and generally, to submit information for a performance category using a single submission mechanism. Too many different permutations would create additional complexities that could create confusion amongst MIPS eligible clinicians as to what is or is not allowed.
We have heard from stakeholders about our MIPS proposals. There are some major concerns, particularly for the transition year (MIPS payment year 2019), about program complexity, not having sufficient time to understand the program before being measured, and potentially receiving negative adjustments. Based on stakeholder feedback discussed in this section, we are adjusting multiple parts of our proposed scoring approach to enhance the likelihood MIPS eligible clinicians who may have not had time to prepare can succeed under the program. We believe that these adjustments will enable more robust and thorough engagement with the program over time. Specifically, we have modified performance standards for the performance categories used to evaluate the measures and activities as well as the methodology to create a final score, and we lowered the performance threshold. Thus, we have created a transition year scoring methodology that does the following:
• Provides a negative 4 percent payment adjustment to MIPS eligible clinicians who do not submit any data to MIPS;
• Ensures that MIPS eligible clinicians who submit data and meet program requirements under any of the three performance categories for which data must be submitted (quality, improvement activities, and advancing care information) for at least a 90-day period,
• Ensures that MIPS eligible clinicians who submit data and meet program requirements under each of the three performance categories for which data must be submitted (quality, improvement activities, and advancing care information) for at least a 90-day period, and have average to high overall performance across the three categories may receive a final score above the performance threshold and thus a higher positive adjustment, and, for those MIPS eligible clinicians who receive a final score at or above the additional performance threshold, an additional positive adjustment.
The detailed policies for scoring the four performance categories are described in section II.E.6.a of the proposed rule (81 FR 28248). However, as the four performance categories collectively create a single MIPS final score, there are some cross-cutting policies that we proposed to apply to multiple performance categories.
Section 1848(q)(3)(A) of the Act requires the Secretary to establish performance standards for the measures and activities in the four MIPS performance categories. Section 1848(q)(3)(B) of the Act requires the Secretary, in establishing performance standards for measures and activities for the four MIPS performance categories, to consider historical performance standards, improvement, and the opportunity for continued improvement. We proposed to define the term, performance standards, at § 414.1305 as the level of performance and methodology that the MIPS eligible clinician is assessed on for a MIPS performance period at the measures and activities level for all MIPS performance categories. We defined the term, MIPS payment year, at § 414.1305 as the calendar year in which MIPS payment adjustments are applied. Performance
The following is a summary of the comments we received regarding our performance standard proposals.
When performance standards for certain quality measures are not known prior to the performance period, we are implementing protections for MIPS eligible clinicians who ultimately perform poorly on these measures. For example, as discussed in section II.E.6.a.(2)(b) of this final rule with comment period, we have added quality performance floors for the transition year to protect MIPS eligible clinicians against unexpectedly low performance scores. For cost measures, the benchmarks will be based on performance period data and cannot be published in advance. However, we do plan to provide feedback on performance so that MIPS eligible clinicians can understand their performance and improve in subsequent years. We will provide feedback before the performance period based on prior period data, illustrating how MIPS eligible clinicians might perform on these measures and we will provide feedback after the performance period based on performance period data, illustrating how MIPS eligible clinicians actually performed on these measures.
In addition, as discussed in section II.E.5.e.(2) of this final rule with comment period, we are also lowering the weight of the cost performance category to 0 percent of the final score for the transition year.
Finally, as discussed in section II.E.7.c of this final rule with comment period, we are lowering the performance threshold for this transition year.
After consideration of the comments, we are finalizing the term, performance standards, at § 414.1305 as the level of performance and methodology that the MIPS eligible clinician is assessed on for a MIPS performance period at the measures and activities level for all MIPS performance categories. We are finalizing at § 414.1380(a) that MIPS eligible clinicians are scored under MIPS based on their performance on measures and activities in four performance categories. MIPS eligible clinicians are scored against performance standards for each performance category and receive a final score, composed of their scores on individual measures and activities, and calculated according to the final score methodology. We are also finalizing at § 414.1380(a)(1) that measures and activities in the four performance categories are scored against performance standards.
MIPS eligible clinicians will know, in advance of the performance period, the methodology for determining the performance standards and the methodology that will be used to score their performance. MIPS eligible clinicians will know the numerical performance standards in the quality performance category in advance of the performance period, when possible. A summary of the performance standards per performance category is provided in Table 15. As discussed in section II.E.6.a.(2) of this final rule with comment period, we are finalizing at § 414.1380(a)(1)(i) that for the quality performance category, measures are scored between zero and 10 points. Performance is measured against benchmarks. Bonus points are available for both submitting specific types of measures and submitting measures using end-to-end electronic reporting. As discussed in section II.E.6.a.(3) of this final rule with comment period, we are finalizing at § 414.1380(a)(1)(ii) that for the cost performance category, that measures are scored between one and 10 points. Performance is also measured against benchmarks. As discussed in section II.E.6.a.(4), we are also finalizing at § 414.1380(a)(1)(iii) that for the improvement activities performance category each improvement activity is worth a certain number of points. The points for each reported activity are summed and scored against a total potential performance category score of 40 points as discussed in section. As discussed in section II.E.6.a.(5) of this final rule with comment period, we are finalizing at § 414.1380(a)(1)(iv), that for the advancing care information performance category, the performance category score is the sum of a base score, performance score, and bonus score.
As discussed in section II.E.6.a.(2) of this final rule with comment period, we are making changes to the quality performance category in response to comments received and are providing a minimum floor for all submitted measures to provide additional safeguards in the transition year. As discussed in section II.E.6.a.(4) of this final rule with comment period, we are making a minor modification to the improvement activities standard to provide additional clarification on improvement activities scoring and to align with comments received. Further, as discussed in section II.E.5.f of this final rule with comment period, we are making additional changes to the advancing care information performance category to align with comments
Section 1848(q)(5)(A) of the Act requires the Secretary to develop a methodology for assessing the total performance of each MIPS eligible clinician according to performance standards for applicable measures and activities in each performance category applicable to the MIPS eligible clinician for a performance period. While MIPS has four different performance categories, we proposed a unified scoring system that enables MIPS eligible clinicians, beneficiaries, and stakeholders to understand what is required for a strong performance in MIPS while being consistent with statutory requirements. We sought to keep the scoring as simple as possible, while providing flexibility for the variety of practice types and reporting options. We proposed to incorporate the following characteristics into the scoring methodologies for each of the four MIPS performance categories:
• For the quality and cost performance categories, all measures would be converted to a 10-point scoring system which provides a framework to universally compare different types of measures across different types of MIPS eligible clinicians. We noted that a similar point framework has been successfully implemented in several other CMS quality programs including the Hospital VBP Program.
• The measure and activity performance standards would be published, where feasible, before the performance period begins, so that MIPS eligible clinicians can track their performance during the performance period. This transparency would make the information more actionable to MIPS eligible clinicians.
• Unlike the PQRS or the EHR Incentive Program, we proposed that we generally would not include “all-or-nothing” reporting requirements for MIPS. The methodology would score measures and activities that meet certain standards defined in section II.E.5 of the proposed rule (81 FR 28181 through 28247) and this section of the final rule with comment period. However, section 1848(q)(5)(B)(i) of the Act provides that under the MIPS scoring methodology, MIPS eligible clinicians who fail to report on an applicable measure or activity that is required to be reported shall be treated as receiving the lowest possible score for the measure or activity. Therefore, MIPS eligible clinicians that fail to report specific measures or activities would receive zero points for each required measure or activity that they do not submit to MIPS.
• The scoring system would ensure sufficient reliability and validity by only scoring the measures that meet certain standards (such as the required case minimum). The standards are described later in this section.
• The scoring proposals provide incentives for MIPS eligible clinicians to invest and focus on certain measures and activities that meet high priority policy goals such as improving beneficiary health, improving care coordination through health information exchange, or encouraging APM Entity participation.
• Performance at any level would receive points towards the performance category scores.
We noted that we anticipated scoring in future years would continue to align and simplify. We requested comment on the characteristics of the proposed unified scoring system.
We also proposed at § 414.1325 that MIPS eligible clinicians and groups may elect to submit information via multiple mechanisms; however, they must use the same identifier for all performance categories and they may only use one
In carrying out MIPS, section 1848(q)(1)(E) of the Act requires the Secretary to encourage the use of QCDRs under section 1848(m)(3)(E) of the Act. In addition, section 1848(q)(5)(B)(ii) of the Act provides that under the methodology for assessing the total performance of each MIPS eligible clinician, the Secretary shall encourage MIPS eligible clinicians to report on applicable measures under the quality performance category through the use of CEHRT and QCDRs. To encourage the use of QCDRs, we proposed opportunities for QCDRs to report new and innovative quality measures. In addition, several improvement activities emphasize QCDR participation. Finally, we proposed under section II.E.5.a of the proposed rule (81 FR 28181) for QCDRs to be able to submit data on all MIPS performance categories. We believe these flexible options would allow MIPS eligible clinicians to meet the submission criteria for MIPS in a low burden manner, which in turn may positively affect their final score. We further believe these flexibilities encourage use of end-to-end electronic data extraction and submission where feasible today, and foster further development of methods that avoid manual data collection where automation is a valid, reliable option and that promote the goal of capturing data once and re-using it for multiple appropriate purposes.
In addition, section 1848(q)(5)(D) of the Act lays out the requirements for incorporating performance improvement into the MIPS scoring methodology beginning with the second MIPS performance period, if data sufficient to measure improvement is available. Section 1848(q)(5)(D)(ii) of the Act also provides that achievement may be weighted higher than improvement. Stated generally, we consider achievement to mean how a MIPS eligible clinician performs relative to performance standards, and improvement to mean how a MIPS eligible clinician performs compared to the MIPS eligible clinician's own previous performance on measures and activities in a performance category. Improvement would not be scored for the transition year of MIPS, but we solicited comment on how best to incorporate improvement scoring for all performance categories.
The following is a summary of the comments we received regarding our proposal for a unified scoring system.
We have simplified the overall scoring approach for MIPS eligible clinicians in the transition year. Under this scoring approach, MIPS eligible clinicians who report measures/activities with minimal levels of performance will not be subject to negative payment adjustments if their final score is at or above the performance threshold. We believe having scores for individual performance categories aligns with the statute; however, we have provided numerous examples within section II.E.6.a.(2)(g) of this final rule with comment period to provide transparency as to how we will calculate MIPS eligible clinicians' scores and help MIPS eligible clinicians to understand how to succeed in the program. Further, we will continue to provide additional materials to create a transparent and standardized scoring system.
After consideration of these comments, we are finalizing all of our policies related to unified scoring as proposed, except we are modifying our proposed policy on scoring quality measures.
We list below all policies we are finalizing related to our proposed unified scoring system.
• For the quality and cost performance categories, all measures will be converted to a 10-point scoring system which provides a framework to universally compare different types of measures across different types of MIPS eligible clinicians.
• The measure and activity performance standards will be published, where feasible, before the performance period begins, so that MIPS eligible clinicians can track their performance during the performance period.
• MIPS eligible clinicians who fail to report specific measures or activities would receive zero points for each required measure or activity that they do not submit to MIPS.
• The scoring policies provide incentives for MIPS eligible clinicians to invest and focus on certain measures and activities that meet high priority policy goals such as improving beneficiary health, improving care coordination through health information exchange, or encouraging APM Entity participation.
• Performance at any level would receive points towards the performance category scores.
We also are finalizing at § 414.1325 that MIPS eligible clinicians and groups may elect to submit information via multiple mechanisms; however, they must use the same identifier for all performance categories and they may only use one submission mechanism per performance category. For example, a MIPS eligible clinician could use one submission mechanism for sending quality measures and another for sending improvement activities data, but a MIPS eligible clinician could not use two submission mechanisms for a single performance category, such as submitting three quality measures via claims and three quality measures via registry. We did intend to allow flexibility, for example, in rare situations where a MIPS eligible clinician submits data for a performance category via multiple submission mechanisms (for example, submits data for the quality performance category through a registry and QCDR), we will score all the options (such as scoring the quality performance category with data from a registry, and also scoring the quality performance category with data from a QCDR) and use the highest performance category score for the MIPS eligible clinician final score. We will not however, combine the submission mechanisms to calculate an aggregated performance category score. The one exception to this policy is CAHPS for MIPS, which is submitted using a CMS-approved survey vendor. CAHPS for MIPS can be scored in conjunction with other submission mechanisms.
With regard to the above policy, we note that some submission mechanisms allow for multiple measure types, such as a QCDR could submit data on behalf of an eligible clinician for a mixture of MIPS eCQMs and non-MIPS measures. However, we recognize that the scoring of only one submission mechanism in the transition year may influence which measures a MIPS eligible clinician selects to submit for the performance period. For example, a MIPS eligible clinician or group may only be able to report a limited number of measures relevant to their practice through a given submission mechanism, and therefore they may elect to choose a different submission mechanism through which a more robust set of measures relevant to their practice is available. We are seeking comment on whether we should modify this policy to allow combined scoring on all measures submitted across multiple submission mechanisms within a performance category. Specifically, we are seeking comment on the following questions:
• Would offering a combined performance category score across submissions mechanisms encourage electronic reporting and the development of more measures that effectively use highly reliable, accurate clinical data routinely captured by CEHRT in the normal course of delivering safe and effective care? If so, are there particular approaches to the performance category score combination that would provide more encouragement than others?
• What approach should be used to combine the scores for quality measures from multiple submission mechanisms into a single aggregate score for the quality performance category? For example, should CMS offer a weighted average score on quality measures submitted through two or more different mechanisms? Or take the highest scores for any submitted measure regardless of how the measure is submitted?
• What steps should CMS and ONC consider taking to increase clinician and consumer confidence in the reliability of the technology used to extract, aggregate, and submit electronic quality measurement data to CMS?
• What enhancements to submission mechanisms or scoring methodologies for future years might reinforce incentives to encourage electronic reporting and improve reliability and comparability of CQMs reported by different electronic mechanisms?
We are modifying our proposed policy on scoring quality measures. Specifically, as discussed in section II.E.6.a.(2)(b) of this final rule with comment period, for the transition year, we are providing a global minimum floor of 3 points for all quality measures submitted. As discussed in section II.E.6.a.(2)(c) of the final rule with comment period, we are also modifying our proposed policy in which we would only score the measures that meet certain standards (such as required case minimum). For the transition year, we are automatically providing 3 points for quality measures that are submitted, regardless of whether they lack a benchmark or do not meet the case minimum or data completeness requirements. Finally, as discussed in section II.E.6.h of this final rule with comment period, we intend to propose options for scoring based on improvement through future rulemaking.
Various policies related to scoring the four performance categories are finalized at § 414.1380(b) and described in more detail in sections II.E.6.a.(2), II.E.6.a.(3), II.E.6.a.(4), and II.E.5.g.(6) of this final rule with comment period.
In other Medicare quality programs, such as the Hospital VBP Program, we have adopted a baseline period that occurs prior to the performance period for a program year to measure improvement and to establish performance standards. We view the MIPS Program as necessitating a similar baseline period for the quality performance category. We intend to establish a baseline period for each performance period for a MIPS payment year to measure improvement for the quality performance category and to enable us to calculate performance standards that we can establish and announce prior to the performance period. As with the Hospital VBP Program, we intend to adopt one baseline period for each MIPS payment year that is as close as possible in duration to the performance period specified for a MIPS payment year. In addition, evaluating performance compared to a baseline period may enable other payers to incorporate MIPS benchmarks into their programs. For each MIPS payment year, we proposed at section II.E.6.a.(1)(c) of the proposed rule (81 FR 28250) that the baseline period would be the 12-month calendar year that is 2 years prior to the performance period for the MIPS payment year. Therefore, for the first MIPS payment year (CY 2019 payment adjustments), for the quality performance category, we proposed that the baseline period would be CY 2015 which is 2 years prior to the proposed CY 2017 performance period. As discussed in section II.E.6.a.(2)(a) of the proposed rule (81 FR 28251), we proposed to use performance in the baseline period to set benchmarks for the quality performance category, with the exception of new measures for which we would set the benchmarks using performance in the performance period and an exception for CMS Web Interface reporters, which will use the benchmarks associated with Shared Savings Program. For the cost performance category, we proposed to set the benchmarks using performance in the performance period and not the baseline period, as discussed in section II.E.6.a.(3) of the proposed rule (81 FR 28259). For the cost performance category, we also made an alternative proposal to set the benchmarks using performance in the baseline period. We proposed to define the term “measure benchmark” for the quality and cost performance categories (81 FR 28250) as the level of performance that the MIPS eligible clinician will be assessed on for a performance period at the measures and activities level.
The following is a summary of the comments we received regarding our proposal to define the baseline period.
We will use performance in the baseline period to set benchmarks for the quality performance category, with the exception of new quality measures, or quality measures that lack historical data, for which we would set the benchmarks using performance in the performance period, and an exception for CMS Web Interface reporters which we will use the benchmarks associated with the Shared Savings Program. For the cost performance category, we will set the benchmarks using performance in the performance period and not the baseline period. We are defining the term “measure benchmark” for the quality and cost performance categories at § 414.1305 as the level of performance that the MIPS eligible clinician is assessed on for a specific performance period at the measures and activities level.
In section II.E.5.b.(3) of the proposed rule, we proposed multiple ways that MIPS eligible clinicians may submit data for the quality performance category to MIPS; however, we proposed that the scoring methodology would be consistent regardless of how the data is submitted. In summary, we proposed at § 414.1380(b)(1) to assign 1-10 points to each measure based on how a MIPS eligible clinician's performance compares to benchmarks. Measures must have the required case minimum to be scored. We proposed that if a MIPS eligible clinician fails to submit a measure required under the quality performance category criteria, then the MIPS eligible clinician would receive zero points for that measure. We proposed that MIPS eligible clinicians would not receive zero points if the required measure is submitted (meeting the data completeness criteria as defined in section II.E.5.b.(3)(b) of the proposed rule (81 FR 28188) but is unable to be scored for any of the reasons listed in section II.E.6.a.(2) of the proposed rule (81 FR 28250), such as not meeting the required case minimum or a measure lacks a benchmark. We described in section II.E.6.a.(2)(d) of the proposed rule (81 FR 28254), examples of how points would be allocated and how to compute the overall quality performance category score under these scenarios. Bonus points would be available for reporting high priority measures, defined as outcome, appropriate use, efficiency, care coordination, patient safety, and patient experience measures.
As discussed in section II.E.6.a.(2)(g) of the proposed rule (81 FR 28256), the quality performance category score would be the sum of all the points assigned for the scored measures required for the quality performance category plus the bonus points (subject
In section II.E.6.b of the proposed rule (81 FR 28269), we discussed how we would score MIPS eligible clinicians who do not have any scored measures in the quality performance category. The details of the proposed scoring methodology for the quality performance category are described below.
For the quality performance category, we proposed at section II.E.6.a.(2)(a) of the proposed rule (81 FR 28251) that the performance standard is measure-specific benchmarks. Benchmarks would be determined based on performance on measures in the baseline period. For quality performance category measures for which there are baseline period data, we proposed to calculate an array of measure benchmarks based on performance during the baseline period, breaking baseline period measure performance into deciles. Then, a MIPS eligible clinician's actual measure performance during the performance period would be evaluated to determine the number of points that should be assigned based on where the actual measure performance falls within these baseline period benchmarks. If a measure does not have baseline period information (for example, new measures), or if the measure specifications for the baseline period differ substantially from the performance period (for example, when the measure requirements change due to updated clinical guidelines), then we proposed to determine the array of benchmarks based on performance on the measure in the performance period, breaking the actual performance on the measure into deciles. In addition, we proposed to create separate benchmarks for submission mechanisms that do not have comparable measure specifications. For example, several eCQMs have specifications that are different than the corresponding measure from registries. We proposed to develop separate benchmarks for EHR submission mechanisms, claims submission mechanisms, and QCDRs and qualified registry submission mechanisms.
For CMS Web Interface reporting, we proposed to use the benchmarks from the Shared Savings Program as described at
As an alternative approach, we considered creating CMS Web Interface specific benchmarks for MIPS instead of using the Shared Savings Program benchmarks. This alternative approach for MIPS benchmarks would be restricted to CMS Web Interface reporters and would not include other MIPS data submission methods or other data sources which are currently used to create the Shared Saving Program benchmarks. This alternative would also apply the topped out cluster approach if any measures are topped out. While we see benefit in having CMS Web Interface methodology match the other MIPS benchmarks, we are also concerned about the Shared Saving Program and the Next Generation ACO Model participants having conflicting benchmark data. We requested comments on building CMS Web Interface specific benchmarks.
We proposed that all MIPS eligible clinicians, regardless of whether they report as an individual or group, and regardless of specialty, that submit data using the same submission mechanism would be included in the same benchmark. We proposed to unify the calculation of the benchmark by using the same approach as the VM of weighting the performance rate of each MIPS eligible clinician and group submitting data on the quality measure by the number of beneficiaries used to calculate the performance rate so that group performance is weighted appropriately (77 FR 69321 through 69322). We would also include data from APM Entity submissions in the benchmark but would not score APM Entities using the MIPS scoring methodology. For APM scoring, we refer to section II.E.5.h. of the proposed rule (81 FR 28234).
To ensure that we have robust benchmarks, we proposed that each benchmark must have a minimum of 20 MIPS eligible clinicians who reported the measure meeting the data completeness requirement defined in section II.E.5.b.(3) of the proposed rule (81 FR 28185), as well as meeting the required case minimum criteria for scoring that is defined later in this section. We proposed a minimum of 20 because, as discussed below, our benchmarking methodology relies on assigning points based on decile distributions with decimals. A decile distribution requires at least 10 observations. We doubled the requirement to 20 so that we would be able to assign decimal point values and minimize cliffs between deciles. We did not want to increase the benchmark sample size requirement due to concerns that an increase could limit the number of measures with benchmarks.
We also proposed that MIPS eligible clinicians who report measures with a performance rate of 0 percent would not be included in the benchmarks. In our initial analysis, we identified some measures that had a large cluster of eligible clinicians with a 0 percent performance rate. We were concerned that the 0 percent performance rate represents clinicians who are not actively engaging in that measurement activity. We did not want to inappropriately skew the distribution. We solicited comment on whether or not to include 0 percent performance in the benchmark.
We proposed at § 414.1380(b)(1)(i) to base the benchmarks on performance in the baseline period when possible. We
We considered not scoring measures that either are new to the MIPS program or do not have a historical benchmark based on performance in the baseline period. This policy would be consistent with the VM policy in which we do not score measures that have no benchmark (77 FR 69322). However, in the proposed rule (81 FR 28252), we expressed concerned that such a policy could stifle reporting on innovative new measures because it would take several years for the measure to be incorporated into the performance category score. We also believed that any issues related to reporting a new measure would not disproportionately affect the relative performance between MIPS eligible clinicians.
We also considered a variation on the scoring methodology that would provide a floor for a new MIPS measure. Under this variation, if a MIPS eligible clinician reports a new measure under the quality performance category, the MIPS eligible clinician would not score lower than 3 points for that measure. This would encourage reporting on new measures, but also prevent MIPS eligible clinicians from receiving the lowest scores for a new measure, while still measuring variable performance. Finally, we also considered lowering the weight of a new measure, so that new measures would contribute relatively less to the score compared to other measures. In the end, we did not propose the alternatives we considered, because we wanted to encourage adoption and measured performance of new measures, however, we did request comment on these alternatives, including comments on what the lowest score should be for MIPS eligible clinicians who report a new measure under the quality performance category and protections against potential gaming related to reporting of new measures only. We also sought comments on alternative methodologies for scoring new measures under the quality performance category, which would assure equity in scoring between the methodology for measures for which there is baseline period data and for new measures which do not have baseline period data available.
Finally, we clarified that some PQRS reporting mechanisms have limited experience with all-payer data. For example, under PQRS, all-payer data was permitted only when reporting via registries for measure groups; reporting via registries for individual measures was restricted to Medicare only. Under MIPS, however, we proposed to have more robust data submissions, as described in section II.E.5.b.(3) of the proposed rule (81 FR 28188). We recognized that comparing all-payer performance to a benchmark that is built, in part, on Medicare data is a limitation and noted we would monitor the benchmarks to see if we need to develop separate benchmarks. We also noted that this data issue would resolve in a year or two, as new MIPS data becomes the historical benchmark data in future years.
The following is a summary of the comments we received regarding our proposals for quality measure benchmarks.
When no comparable data exists from the baseline period, then we finalize that we will use information from the performance period (CY 2017 for the transition year, during which MIPS eligible clinicians may report for a minimum of any continuous 90-day period, as discussed in section II.E.4 of this final rule with comment period) to assess measure benchmarks. In this case, while the benchmark methodology is being finalized in this final rule with comment period, the numerical benchmarks will not be known in advance of the performance period. However, as discussed throughout this final rule with comment period, we have added protections to protect MIPS eligible clinicians from poor performance, particularly in the transition year.
We estimated quality performance scores by practice size based on historical data and did not see a systematic difference in performance by practice among MIPS eligible clinicians that submitted complete and reliable data to require a need for separate benchmarks. However, as we monitor the MIPS program, we will continue to evaluate whether we need to further refine and stratify the benchmarks.
The VM defines relative performance as statistical difference from the mean for a measure, and weights each clinician's performance rate by the number of beneficiaries to identify the average score for a measure, a single unit. However, unlike the VM, in MIPS, we are not defining relative performance by using a single point, but rather a percentile distribution of the reliable clinician summary performance scores. We have taken steps to ensure that each clinician or group score meets certain standards to promote reliability at the group or individual clinician level. For example, the group or individual reporter must meet certain case volume and data completeness standards to be included in the MIPS benchmark. In MIPS, weighting individual or group values by the number of patients is similar to cloning or replicating that individual or group score in the percentile distribution. In a distribution benchmark, weighting will not have an impact in the following cases: When the distribution of scores is highly compressed (low variance); the distribution of cases is highly compressed (such as, all practices have fairly similar numbers of cases); or when the number of practices is large relative to the typical number of eligible cases for any practice for the measure. However, the difference between unweighted and weighted benchmarks is more likely to have an impact is when the number of eligible cases and corresponding performance scores vary widely across practices. The difference will be exacerbated if there are relatively few practices and/or if practices with especially high or low scores also have a disproportionately large number of cases. For example, assume a given benchmark has one large group and several smaller groups and individual reporters. The large group cares for 20 percent of the beneficiaries represented in the benchmark. If we weight the benchmark by patient weight, then another MIPS eligible clinician with a score just above or just below that performance rate will have a score that is different by a point or two, not because of differences in performance but because of differences in the number of beneficiaries cared for by the group or individual MIPS eligible clinician.
Therefore, we are not finalizing our proposal to patient weight the benchmarks. Instead, we will count each submission, either by individual or group, as a single data point for the benchmark. We believe this data is reliable and the revision simplifies the combination of group and individual performance.
We considered giving a set number of points for submitting a new measure, rather than measuring performance. We do not think it is equitable to give the maximum performance score (a score equal to the 90th percentile or the top decile) when other eligible clinicians may receive fewer points based on performance.
In addition, for the transition year (first year) only, we are also implementing a global floor of 3 points for all submitted quality measures, not only new measures. This floor, along with changes in the performance threshold, affords MIPS eligible clinicians the ability to learn about MIPS and be protected from a negative adjustment in the transition year for any level of performance.
In this example, we still create an array of percentile distributions for benchmarks and decile breaks. However, where we would normally assign between 1.0-2.9 points for MIPS eligible clinicians with performance in the first or second deciles (in this example, performance between 0 and 15.7 percent), we will now assign 3.0
After consideration of the comments on quality measure benchmarks, we are finalizing many policies as proposed. Specifically:
• For quality measures for which baseline period data is available, we are establishing at § 414.1380(b)(1)(i) measure benchmarks are based on historical performance for the measure based on a baseline period. Each benchmark must have a minimum of 20 individual clinicians or groups who reported the measure meeting the data completeness requirement and minimum case size criteria and performance greater than zero. We will restrict the benchmarks to data from MIPS eligible clinicians, and, as discussed above, comparable APM data, including data from QPs and Partial QPs.
We will publish the numerical baseline period benchmarks prior to the start of the performance period (or as soon as possible thereafter).
• For quality measures for which there is no comparable data from the baseline period, we are establishing at § 414.1380(b)(1)(ii) that CMS will use information from the performance period to create measure benchmarks. We will publish the numerical performance period benchmarks after the end of the performance period. In section II.E.4 of this final rule with comment period, we are finalizing that for the transition year, the performance period will be a minimum of any continuous 90-day period within CY 2017. Therefore, for MIPS payment year 2019, we will use data submitted for performance in CY 2017, during which MIPS eligible clinicians may report for a minimum of any continuous 90-day period.
• We are establishing at § 414.1380(b)(1)(iii) separate benchmarks are used for the following submission mechanisms: EHR submission options; QCDR and qualified registry submission options; claims submission options; CMS Web Interface submission options; CMS-approved survey vendor for CAHPS for MIPS submission options, and administrative claims submission options. As discussed above, we are not stratifying benchmarks by other practice characteristics, such as practice size. For the reasons discussed above, we do not believe that there is a compelling rationale for such an approach, and we believe that stratifying could have unintended negative consequences for the stability of the benchmarks, equity across practices, and quality of care for beneficiaries. However, we continue to receive feedback that small practices should have a different benchmark, so we seek comment on any rationales for or against stratifying by practice size we may not have considered.
• We are establishing at § 414.1380(b)(1)(ii)(A) that the CMS Web Interface submission will use benchmarks from the corresponding reporting year of the Shared Savings Program. We will post the MIPS CMS Web Interface benchmarks in the same manner as the other MIPS benchmarks. We are not building CMS Web Interface-specific benchmarks for the MIPS. We will apply the MIPS scoring methodology to each measure. Measures below the 30th percentile will be assigned a value of 3 points during the transition year to be consistent with the global floor established in this rule for other measures. We will revisit this global floor for future years.
We are modifying our proposed policy with regards to patient weighting. Based on public comments, we are not finalizing our proposal to weight the performance rate of each MIPS eligible clinician and group submitting data on the quality measure by the number of beneficiaries used to calculate the performance rate. Instead, we will count each submission, either by an individual or group, as a single data point for the benchmark. We believe the original proposal could create potential unintended distortions in the benchmark. Therefore we believe it is more appropriate to use a distribution of each individual or group submission that meets our criteria to ensure reliable and valid data.
We are also modifying our proposed policy for scoring new measures. Based on public comments, for the transition year and subsequent years of MIPS, we are adding protection against being unfairly penalized for poor performance on measures without benchmarks by finalizing a 3-point floor for new measures and measures without a benchmark. As discussed in more detail in the next section, for the transition year of MIPS we are also finalizing a 3-point floor for all submitted measures. We will revisit this policy in future years.
We proposed in § 414.1380(b)(1)(x) of the proposed rule (81 FR 28251) to establish benchmarks using a percentile distribution, separated into deciles, because it translates measure-specific score distributions into a uniform distribution of MIPS eligible clinicians based on actual performance values. For each set of benchmarks, we proposed to calculate the decile breaks for measure performance and assign points for a measure based on the benchmark decile range in which the MIPS eligible clinician's performance rate on the measure falls. For example, MIPS eligible clinicians in the top decile would receive 10 points for the measure, and MIPS eligible clinicians in the next lower decile would receive points ranging from 9 to 9.9. We proposed to assign partial points to prevent performance cliffs for MIPS eligible clinicians near the decile breaks. The partial points would be assigned based on the percentile distribution.
Table 17 of the proposed rule (81 FR 28252) illustrated an example of using decile points along with partial points to assign achievement points for a sample quality measure. We noted in the proposed rule (81 FR 28252) that any MIPS eligible clinician who reports some level of performance would receive a minimum of one point for reporting if the measure has the required case minimum, assuming the measure has a benchmark.
We did not propose to base scoring on decile distributions for the same measure ranges as described in Table 17 of the proposed rule when performance is clustered at the high end (that is, “topped out” measures), as true variance cannot be assessed. MIPS eligible clinicians report on different measures and may elect to submit measures on which they expect to perform well. For MIPS eligible clinicians electing to report on measures where they expect to perform well, we anticipated many measures would have performance distributions clustered near the top. We proposed to identify “topped out” measures by using a definition similar to the definition used in the Hospital VBP Program: Truncated
Using 2014 PQRS quality reported data measures, we modeled the proposed benchmark methodology and identified that approximately half of the measures proposed under the quality performance category are topped out. Several measures have a median score of 100 percent, which makes it difficult to assess relative performance needed for the quality performance category score.
However, we did not believe it would be appropriate to remove topped out measures at this time. As not all MIPS eligible clinicians would be required to report these measures under our proposals for the quality performance category in section II.E.5.b. of the proposed rule (81 FR 28184), it would be difficult to determine whether a measure is truly topped out or if only excellent performers are choosing to report the measure. We also believed removing such a large volume of measures would make it difficult for some specialties to have enough applicable measures to report. At the same time, we did not believe that the highest values on topped out measures convey the same meaning of relative quality performance as the highest values for measures that are not topped out. In other words, we did not believe that eligible clinicians electing to report topped out process measures should be able to receive the same maximum score as eligible clinicians electing to report preferred measures, such as outcome measures.
Therefore, we proposed to modify the benchmark methodology for topped out measures. Rather than assigning up to 10 points per measure, we proposed to limit the maximum number of points a topped out measure can achieve based on how clustered the scores are. We proposed to identify clusters within topped out measures and would assign all MIPS eligible clinicians within the cluster the same value, which would be the number of points available at the midpoint of the cluster. That is, we proposed to take the midpoint of the highest and lowest scores that would pertain if the measure was not topped out and the values were not clustered. We proposed to only apply this methodology for benchmarks based on the baseline period. When we develop the benchmarks, we would identify the clusters and state the points that would be assigned when the measure performance rate is in a cluster. We proposed to notify MIPS eligible clinicians when those benchmarks are published with regard to which measures are topped out.
We proposed this approach because we wanted to encourage MIPS eligible clinicians not to report topped out measures, but to instead choose other measures that are more meaningful. We also sought feedback on alternative ways and an alternative scoring methodology to address topped out measures so that topped out measures do not disproportionately affect a MIPS eligible clinician's quality performance category score. Other alternatives could include placing a limit on the number of topped out measures MIPS eligible clinicians may submit or reducing the weight of topped out measures. We also considered whether we should apply a flat percentage in building the benchmarks, similar to the Shared Savings Program, where MIPS eligible clinicians are scored on their percentage of their performance rate and not on a decile distribution and requested comment on how to apply such a methodology without providing an incentive to report topped out measures. Under the Shared Savings Program, 42 CFR 425.502, there are circumstances when benchmarks are set using flat percentages. For some measures, benchmarks are set using flat percentages when the 60th percentile was equal to or greater than 80.00 percent, effective beginning with the 2014 reporting year (78 FR 74759-74763). For other measures benchmarks are set using flat percentages when the 90th percentile was equal to or greater than 95.00 percent, effective beginning in 2015 (79 FR 67925). Flat percentages allow those with high scores to earn maximum or near maximum quality points while allowing room for improvement and rewarding that improvement in subsequent years. Use of flat percentages also helps ensure those with high performance on a measure are not penalized as low performers. We also noted that we anticipate removing topped out measures over time, as we work to develop new quality measures that will eventually replace these topped out measures. We requested feedback on these proposals.
The following is a summary of the comments we received regarding our proposal to assign points based on achievement.
We plan to identify topped out measures for benchmarks based on the baseline period when we post the detailed measures specifications and the measure benchmarks prior to the start of the performance period. This will count as the first year a measure is identified as topped out. The second year the same measure is topped out, we will apply a topped out measure scoring standard beginning in performance periods occurring in 2018. We note as reflected above we are seeking comment on the topped out measure scoring standard. We also plan to identify topped out measures for benchmarks based on the performance period.
After consideration of the comments, we are not finalizing all of our policies as proposed.
We are establishing that the performance standard with respect to the quality performance category is measure-specific benchmarks. Specifically, we are finalizing at § 414.1380(b)(1) that, for the 2017 performance period, MIPS eligible clinicians receive three to ten achievement points for each scored quality measure in the quality performance category based on the MIPS eligible clinician's performance compared to measure benchmarks. A MIPS quality measure must have a measure benchmark to be scored based on performance. MIPS quality measures that do not have a benchmark will not be scored based on performance. Instead, these measures will receive 3 points for the 2017 performance period.
We are finalizing at § 414.1380(b)(1)(ix), that measures submitted by MIPS eligible clinicians are scored using a percentile distribution, separated by decile categories. As discussed below, for MIPS payment year 2019, topped out quality measures are not scored differently than quality measures that are not considered topped out. At § 414.1380(b)(1)(x), we finalize that for each set of benchmarks, CMS calculates the decile breaks for measure performance and assigns points based on which benchmark decile range the MIPS eligible clinician's measure rate is between. At § 414.1380(b)(1)(xi) we assign partial points based on the percentile distribution. In § 414.1380(b)(1)(xii) MIPS eligible clinicians are required to submit measures consistent with § 414.1335.
Based on public comments, we are finalizing a modification to our proposal for the benchmark methodology for topped out measures. Specifically, we will not modify the benchmark methodology for topped out measures for the first year that the measure has been identified as topped out. Rather, for the first year the measure has been identified as topped out we will score topped out measures in the same manner as other measures until the second year the measure has been identified as topped out. The first year that any measure can be identified as topped out is the transition year, that is, the CY 2017 performance period. Thus, we will not modify the benchmark methodology for any topped out measures for the CY 2017 performance period. We will modify the benchmark methodology for topped out measures beginning with the CY 2018 performance period, provided that it is the second year the measure has been identified as topped out. We seek comment on how topped out measures would be scored provided that it is the second year the measure has been identified as topped out. One option would be to score the measures using a mid-cluster approach. Under this approach, beginning with the CY 2018 performance period, we would limit the maximum number of points a topped out measure can achieve based on how clustered the scores are. We would identify clusters within topped out measures and assign all MIPS eligible clinicians within the cluster the same value, which will be the number of points available at the midpoint of the cluster. That is, we would take the midpoint of the highest and lowest scores that would pertain if the measure were not topped out and the values were not clustered. We would only apply this methodology for measures with benchmarks based on the baseline period. When we develop the benchmarks, we would identify the clusters and state the points that would be assigned when the measure performance rate is in a cluster. We would notify MIPS eligible clinicians when those benchmarks are published with regard to which measures are topped out. Another approach would be to remove topped out measures in the CY 2018 performance period, provided that it is the second year the measure has been identified as topped out. In this instance, we would not score these measures. Finally, a third approach would be to apply a flat percentage in building the benchmarks for topped out measures, similar to the Shared Savings Program, where MIPS eligible clinicians are scored on the performance rate rather than their place in the performance rate distribution. We request comment on how to apply such a methodology without providing an incentive to report topped out measures. Under the Shared Savings Program, 42 CFR 425.502, there are circumstances when benchmarks are set using flat percentages. For some measures, benchmarks are set using flat percentages when the 60th percentile was equal to or greater than 80.00 percent, effective beginning with the 2014 reporting year (78 FR 74759-74763). For other measures benchmarks are set using flat percentages when the 90th percentile was equal to or greater than 95.00 percent, effective beginning in 2015 (79 FR 67925). Flat percentages allow those with high scores to earn maximum or near maximum quality points while allowing room for improvement and rewarding that improvement in subsequent years. Use of flat percentages also helps ensure those with high performance on a measure are not penalized as low performers. We seek comment on each of these three options. Finally, we also note that we anticipate removing topped out measures over time, as we work to develop new quality measures that will eventually replace these topped out measures. We seek comment on at what point in time should measures that are topped out be removed from the MIPS.
We are modifying our proposed approach to identify topped out measures. We had proposed to identify all topped out measures by using a definition similar to the definition used in the Hospital VBP Program: Truncated Coefficient of Variation
In addition, as discussed in section II.E.6.a.(2)(a) of this final rule with comment period, we will add a global 3-point floor for all submitted measures for the transition year by assigning the decile breaks for measure performance between 3 and 10 points. We will revisit
We provide some examples below of the total possible points that MIPS eligible clinicians could receive under the quality performance category under our revised methodology. As described in section II.E.5.b. of this rule, MIPS eligible clinicians are required to submit six measures or measures from a specialty measure set, and we would also score MIPS eligible clinicians on the all-cause hospital readmission measure for groups of 16 or more with sufficient case volume (200 cases). The total possible points for the quality performance category would be 70 points for groups of 16 or more clinicians (6 submitted measures × 10 points + 1 all-cause hospital readmission measure × 10 points = 70). Further, the total possible points for small practices of 15 or fewer clinicians and solo practitioners and MIPS individual reporters (or for groups with less than 200 cases for the readmission measure) would be 60 points (6 submitted measures × 10 points = 60) because the all-cause hospital readmissions measure would not be applicable.
However, for groups reporting via CMS Web Interface and that have sufficient case volume for the readmission measure, the total possible points for the quality performance category would vary between 120-150 points as discussed in Table 24 in section II.E.6.a.(2)(g)(ii) of this rule. If all measures are reported, then the total possible points is 120 points: (11 measures × 10 points) + (1 all-cause hospital readmission measures × 10 points) = 120; for those groups with sufficient case volume (200 cases) to be measured on readmissions. We discuss in section II.E.6.a.(2)(g)(ii) why the total possible points vary based on whether measures without a benchmark are reported. For other CMS Web Interface groups without sufficient volume for the readmissions measure, the readmission measure will not be scored, and the total possible points for the quality performance category would vary between 110-140 points, instead of 120-150 as discussed in section II.E.6.a.(2)(g)(ii).
We seek to ensure that MIPS eligible clinicians are measured reliably; therefore, we proposed at § 414.1380(b)(1)(iv) to use for the quality performance category measures the case minimum requirements for the quality measures used in the 2018 VM (see § 414.1265): 20 cases for all quality measures, with the exception of the all-cause hospital readmissions measure, which has a minimum of 200 cases. We referred readers to Table 46 of the CY 2016 PFS final rule (80 FR 71282), which summarized our analysis of the reliability of certain claims-based measures used for the 2016 VM payment adjustment. MIPS eligible clinicians that report measures with fewer than 20 cases (and the measure meets the data completeness criteria) would receive recognition for submitting the measure, but the measure would not be included for MIPS quality performance category scoring. Since the all-cause hospital readmissions measure does not meet the threshold for what we consider to be moderate reliability for solo practitioners and groups of less than ten MIPS eligible clinicians for purposes of the VM (see Table 46 of the CY 2016 PFS final rule, referenced above), for consistency, we proposed to not include the all-cause hospital readmissions measure in the calculation of the quality performance category for MIPS eligible clinicians who individually report, as well as solo practitioners or groups of two to nine MIPS eligible clinicians.
We also proposed that if we identify issues or circumstances that would impact the reliability or validity of a measure score, we would also exclude those measures from scoring. For example, if we discover that there was an unforeseen data collection issue that would affect the integrity of the measure information, we would not include that measure in the quality performance category score. If a measure is excluded, we would recognize that the measure had been submitted and would not disadvantage the MIPS eligible clinicians by assigning them zero points for a non-reported measure.
The following is a summary of the comments we received regarding our proposal to score measures with minimum case volume and validity.
After consideration of the comments, we are finalizing case minimum policies for measures at § 414.1380(b)(1)(iv) and (v). For the quality performance category measures, we will use the following case minimum requirements: 20 cases for all quality measures, with the exception of the all-cause hospital readmissions measure, which has a minimum of 200 cases. We reiterate that we will only apply the all-cause readmission measure to groups of 16 or more MIPS eligible clinicians that meet the case minimum requirement.
Based on public comments, we are revising our proposed policy for all measures, except CMS Web Interface measures and administrative claims-based measures, that are submitted but for which performance cannot be reliably measured because the measures do not meet the required case minimum, do not have a benchmark, or do not meet the data completeness requirement, benchmark or is below the data completeness requirement, it will receive a floor of 3 points. At § 414.1380(b)(1)(vii), for the transition year, we finalize that if the measure is submitted but is unable to be scored because it does not meet the required case minimum, does not have a benchmark, or does not meet the data completeness requirement, the measure will receive a score of 3 points.
We are finalizing our proposed policy for CMS Web Interface measures that are submitted but for which performance cannot be reliably measured because the measures do not meet the required case minimum or do not have a benchmark. At § 414.1380(b)(1)(viii), we are finalizing that the MIPS eligible clinician will receive recognition for submitting such measures, but the measure will not be included for MIPS quality performance category scoring. CMS Web Interface measures that do not meet the data completeness requirement will receive a score of 0. We are also finalizing our proposed policy for administrative claims-based measures for which performance cannot be reliably measured because the measures do not meet the required case minimum or do not have a benchmark. For the transition year, this policy would only apply to the readmission measure since the only administrative claims-based quality measure is the readmission measure. However, this policy will apply to additional administrative claims-based measures that are added in future years. At § 414.1380(b)(1)(viii), we are finalizing that such measures will not be included in the MIPS eligible clinician's quality performance category score. We note that the data completeness requirement does not apply to administrative claims-based measures. Overall, at § 414.1380, we will provide points for all submitted
Generally, if we
We provide below examples of our new scoring approach. For simplicity, the examples not only explain how the to calculate the quality performance category score, but also how the quality performance category score contributes to the final score as described in section II.E.6.b of this final rule with comment period, assuming a quality performance category weight of 60 percent. We use the term weighted score to represent a performance category score that is adjusted for the performance category weight.
If the MIPS eligible clinician, as a solo practitioner, scored 10 out of 10 on each of five measures submitted, one of which was an outcome measure, and had one measure that was below the required case minimum, the MIPS eligible clinician would receive the following weighted score for the quality performance category: (5 measures × 10 points) + (1 measure × 3 points) or 53 out of 60 possible points × 60 (weight of quality performance category) = 53 points toward the final score. Similarly, if the MIPS eligible clinician, as a solo practitioner, scored 10 out of 10 on each of five measures submitted, one of which was an outcome measure, but failed to submit a sixth measure even though there were applicable measures that could have been submitted, the MIPS eligible clinician would receive the following weighted score in the quality performance category: (5 measures × 10 points) + (1 measure × 0 points) or 50 out of 60 possible points × 60 (weight of quality performance category) = 50 points toward the final score.
We also provide examples of instances where MIPS eligible clinicians either do not have 6 applicable measures or the applicable specialty set has less than six measures.
For example, if a specialty set only has 3 measures or if a MIPS eligible clinician only has 3 applicable measures, then, in both instances, the total possible points for the MIPS eligible clinician is 30 points (3 measures × 10 points). If the MIPS eligible clinician scored 8 points on each of the 3 applicable measures submitted, one of which was an outcome measure, then the MIPS eligible clinician would receive the following weighted score in the quality performance category: (3 measures × 8 points) or 24 out of 30 possible points × 60 (weight of quality performance category) = 48 points toward the final score.
Section II.E.5.b. of the proposed rule outlined our proposed quality performance category criteria for the different reporting mechanisms. The criteria vary by reporting mechanism, but generally we proposed to include a minimum of six measures with at least one cross-cutting measure (for patient facing MIPS eligible clinicians) (Table C of the proposed rule at 81 FR 28447) and an outcome measure if available. If an outcome measure is not available, then we proposed that the eligible clinician would report one other high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures) in lieu of an outcome measure. We proposed that MIPS eligible clinicians and groups would have to select their measures from either the list of all MIPS Measures in Table A of the Appendix in the proposed rule (81 FR 28399) or a set of specialty specific measures in Table E of the Appendix in the proposed rule (81 FR 28460). As discussed in section II.E.5.b.(3) of this final rule with comment period, we are not finalizing the requirement for a cross-cutting measure. As discussed in II.E.5.b.(6) of this final rule with comment period, we are also not including two of the three population measures in the scoring.
We noted that there are some special scenarios for those MIPS eligible clinicians who select their measures from the Specialty Sets (Table E of the
For groups using the CMS Web Interface and MIPS APMs, we proposed to have different quality performance category criteria described in sections II.E.5.b. and II.E.5.h. of the proposed rule (81 FR 28187 and 81 FR 28234). Additionally, as described in section II.E.5.b of the proposed rule, we also proposed to score MIPS eligible clinicians on up to three population-based measures.
Previously in PQRS, EPs had to meet all the criteria or be subject to a negative payment adjustment. However, we proposed that MIPS eligible clinicians receive credit for measures that they report, regardless of whether or not the MIPS eligible clinician meets the quality performance category submission criteria. Section 1848(q)(5)(B)(i) of the Act provides that under the MIPS scoring methodology, MIPS eligible clinicians who fail to report on an applicable measure or activity that is required to be reported shall be treated as receiving the lowest possible score for the measure or activity; therefore, for any MIPS eligible clinician who does not report a measure required to satisfy the quality performance category submission criteria, we proposed that the MIPS eligible clinician would receive zero points for that measure. For example, a MIPS eligible clinician who is able to report on six measures, yet reports on four measures, would receive two “zero” scores for the missing measures. However, we proposed that MIPS eligible clinicians who report a measure that does not meet the required case minimum would not be scored on the measure but would also not receive a “zero” score.
We also noted that if MIPS eligible clinicians are able to submit measures that can be scored, we want to discourage them from continuing to submit the same measures year after year that cannot be scored due to not meeting the required case minimum. Rather, to the fullest extent possible, MIPS eligible clinicians should select measures that would meet the required case minimum. We sought comment on any safeguards we should implement in future years to minimize any gaming attempts. For example, if the measures that a MIPS eligible clinician submits for a performance period are not able to be scored due to not meeting the required case minimum, we sought comment on whether we should require these MIPS eligible clinicians to submit different measures with sufficient cases for the next performance period (to the extent other measures are applicable and available to them).
We proposed that MIPS eligible clinicians who report a measure where there is no benchmark due to less than 20 MIPS eligible clinicians reporting on the measure would not be scored on the measure but would also not receive a “zero” score. Instead, these MIPS eligible clinicians would be scored according to the following example: A MIPS eligible clinician who submits six measures through a group of 10 or more clinicians, with one measure lacking a benchmark, would be scored on the five remaining measures and the three population-based measures based on administrative claims data
We stated our intent to develop a validation process to review and validate a MIPS eligible clinician's inability to report on the quality performance requirements as proposed in section II.E.5.b. of the proposed rule. We anticipate that this process would function similar to the Measure Applicability Validity (MAV) process that occurred under PQRS, with a few exceptions. First, the MAV process under PQRS was a secondary process after an EP was determined to not be a satisfactory reporter. Under MIPS, we intend to build the process into our overall scoring approach to reduce confusion and burden on MIPS eligible clinicians by having a separate process. Second, as the requirements under PQRS are different than those proposed under MIPS, the process must be updated to account for different measures and different quality performance requirements. More information on the MAV process under PQRS can be found at
The following is a summary of the comments we received regarding our proposal to score MIPS eligible clinicians that do not meet quality performance category criteria.
After consideration of the comments, we are finalizing at § 414.1380(b)(1)(vi) that MIPS eligible clinicians who fail to report a measure that is required to satisfy the quality performance category submission criteria will receive zero points for that measure. Further, we are finalizing implementation of a validation process for claims and registry submissions to validate whether MIPS eligible clinicians have six applicable and available measures, whether an outcome measure is available or another other high priority measure if an outcome measure is not available.
However, we are not finalizing our proposal that MIPS eligible clinicians who report a measure that does not meet the required case minimum, the data completeness criteria, or for which there is no benchmark due to less than 20 MIPS eligible clinicians reporting the measure, would not receive any points for submission and would not be scored on performance against a benchmark. Rather, as discussed in section II.E.6.a.(2)(c) of this final rule with comment period, for “class 2” measure, as defined in Table 17, that are submitted, but unable to be scored, we will add a 3-point floor for all submitted measures for the transition year. That is, if a MIPS eligible clinician submits a “class 2” measure, as defined in Table 17 we will assign 3 points to the MIPS eligible clinician for submitting that measure regardless of whether the measure meets the data completeness requirement or required case minimum requirement or whether the measure has a benchmark for the transition year. For example, a MIPS eligible clinician who is a solo practitioner could submit 6 measures as follows: 2 measures (one of which is an outcome measure) with high performance, scoring 10 out of 10 on each of these measures, 1 measure that lacks minimum case size, 1 measure that lacks a benchmark, 1 measure that does not meet the data completeness requirement and 1 measure with low performance. In this case, the MIPS eligible clinician would receive 32 out of 60 possible points in the quality performance category (2 measures × 10 points plus 4 measures × 3 points). We will revisit this policy in future years.
Consistent with other CMS value-based payment programs, we proposed that MIPS scoring policies would emphasize and focus on high priority measures that impact beneficiaries. These high priority measures are defined as outcome, appropriate use, patient safety, efficiency, patient experience and care coordination measures; see Tables A through D of the Appendix in the proposed rule (81 FR 28399-28460) for these measures. We proposed these measures as high priority measures given their critical importance to our goals of meaningful measurement and our measure development plan. We note that many of these measures are grounded in NQS domains. For patient safety, efficiency, patient experience and care coordination measures, we refer to the measures within the respective NQS domains and measure types. For outcomes measures, we include both outcomes measures and intermediate outcomes measures. For appropriate use measures, we have noted which measures fall within this category in Tables A through D and provided
We proposed scoring adjustments to create incentives for MIPS eligible clinicians to submit high priority measures and to allow these measures to have more impact on the total quality performance category score.
We proposed to create an incentive for MIPS eligible clinicians to voluntarily report additional high priority measures. We proposed to provide 2 bonus points for each outcome and patient experience measure and 1 bonus point for other high priority measures reported in addition to the one high priority measure (an outcome measure, but if one is not available, then another high priority measure) that would already be required under the proposed quality performance category criteria. For example, if a MIPS eligible clinician submitted 2 outcome measures, and two patient safety measures, the MIPS eligible clinician would receive 2 bonus points for the second outcome measure reported and 2 bonus points for the two patient safety measures. The MIPS eligible clinician would not receive any bonus points for the first outcome measure submitted since that is a required measure. We selected 2 bonus points for outcome measures given the statutory requirements under section 1848(q)(2)(C)(i) of the Act to emphasize outcome measures. We selected 2 bonus points for patient experience measures given the importance of patient experience measures to our measurement goals. We selected 1 bonus point for all other high priority measures given our measurement goals around each of those areas of measurement. We believe the number of bonus points provides extra credit for submitting the measure, yet would not mask poor performance on the measure. For example, a MIPS eligible clinician with poor performance receives only 3 points for performance for a particular high priority measure. The bonus points would increase the MIPS eligible clinician's points to 4 (or 5 if the measure is an outcome measure or patient experience measure), but that amount is far less than the 10 points a top performer would receive. We noted that population-based measures would not receive bonus points.
We noted that a MIPS eligible clinician who submits a high priority measure but had a performance rate of 0 percent would not receive any bonus points. MIPS eligible clinicians would only receive bonus points if the performance rate is greater than zero. Bonus points are also available for measures that are not scored (not included in the top 6 measures for the quality performance category score) as long as the measure has the required case minimum and data completeness. We believe these qualities would allow us to include the measure in future benchmark development.
Groups submitting data through the CMS Web Interface, including MIPS APMs that report through the CMS Web Interface, are required to submit a set of predetermined measures and are unable to submit additional measures (other than the CAHPS for MIPS survey). For that submission mechanism, we proposed to apply bonus points based on the finalized set of measures. We would assign two bonus points for each outcome measure (after the first required outcome measure) and for each patient experience measure. We would also have one additional bonus point for each other high priority measure (patient safety, efficiency, appropriate use, care coordination). We believe MIPS eligible clinicians or groups should have the ability to receive bonus points for reporting high priority measures through all submission mechanisms, including the CMS Web Interface. In this final rule with comment period, we will publish how many bonus points the CMS Web Interface measure set would have available based on the final list of measures (See Table 21).
We proposed to cap the bonus points for the high priority measures (outcome, appropriate use, patient safety, efficiency, patient experience, and care coordination measures) at 5 percent of the denominator of the quality performance category score. Tables 19 and 20 of the proposed rule (81 FR 28257-28258) illustrated examples of how to calculate the bonus cap. We also proposed an alternative approach of capping bonus points for high priority measures at 10 percent of the denominator of the quality performance category score. Our rationale for the 5 percent cap was that we do not want to mask poor performance by allowing a MIPS eligible clinician to perform poorly on a measure but still obtain a high quality performance category score by submitting numerous high priority measures in order to obtain bonus points; however, we were also concerned that 5 percent may not be enough incentive to encourage reporting. We requested comment on the appropriate threshold for this bonus cap.
The following is a summary of the comments we received regarding our proposal to provide bonus points for high priority quality measures.
After consideration of the comments, we are finalizing at § 414.1380(b)(1)(xiii) our proposal to award 2 bonus points for each outcome or patient experience measure and 1 bonus point for each other high priority measure that is reported in addition to the 1 high priority measure that is already required to be reported under the quality performance category submission criteria. We will revisit this policy in future years. High priority measures are defined as outcome, appropriate use, patient safety, efficiency, patient experience and care coordination measures, as identified in Tables A through D in the Appendix of this final rule with comment period. For the CMS Web Interface, we will apply bonus points based on the finalized set of measures reportable through that submission mechanism. MIPS eligible clinicians will only receive bonus points if they submit a high priority measure with a performance rate that is greater than zero, provided that the measure meets the case minimum and data completeness requirements. We believe that this will encourage stronger reporting of those measures that are
The following is a summary of the comments we received regarding our proposal for establishing a cap on bonus points awarded for the reporting of additional high priority measures:
After consideration of the comments, we are finalizing at § 414.1380(b)(1)(xiii) a modification to the proposed high priority measure cap. Specifically, we are increasing the cap for high priority measures from 5 percent to 10 percent of the denominator (total possible points the MIPS eligible clinician could receive in the quality performance category)
Section 1848(q)(5)(B)(ii) of the Act provides that under the methodology for assessing the total performance of each MIPS eligible clinician, the Secretary shall: (1) Encourage MIPS eligible clinicians to report on applicable measures under the quality performance category through the use of CEHRT and QCDRs; and (2) for a performance period for a year, for which a MIPS eligible clinician reports applicable measures under the quality performance category through the use of CEHRT, treat the MIPS eligible clinician as satisfying the CQMs reporting requirement under section 1848(o)(2)(A)(iii) of the Act for such year. To encourage the use of CEHRT for quality improvement and reporting on measures under the quality performance category, we proposed a scoring incentive to MIPS eligible clinicians who use their CEHRT systems to capture and report quality information.
We proposed to allow one bonus point for each measure under the quality performance category score, up to a maximum of 5 percent of the denominator of the quality performance category score if:
• The MIPS eligible clinician uses CEHRT to record the measure's demographic and clinical data elements in conformance to the standards relevant for the measure and submission pathway, including but not necessarily limited to the standards included in the CEHRT definition proposed in § 414.1305;
• The MIPS eligible clinician exports and transmits measure data electronically to a third party using relevant standards or directly to us using a submission method as defined at § 414.1325; and
• The third party intermediary (for example, a QCDR) uses automated software to aggregate measure data, calculate measures, perform any filtering of measurement data, and submit the data electronically to us using a submission method as defined at § 414.1325.
These requirements are referred to as “end-to-end electronic reporting.”
We note that this bonus would be in addition to the bonus points for reporting high priority measures. MIPS eligible clinicians would be eligible for both this bonus option and the high priority bonus option with separate bonus caps for each option. We also proposed an alternative approach of capping bonus points for this option at 10 percent of the denominator of the quality performance category score. Our rationale for the 5 percent cap was that we do not want to mask poor performance by allowing a MIPS eligible clinician to perform poorly on a measure but still obtain a high quality performance category score; however, we were also concerned that 5 percent may not be enough incentive to encourage end-to-end electronic reporting. We sought comment on the appropriate threshold for this bonus cap. We proposed the CEHRT bonus would be available to all submission mechanisms except claims submissions. This incentive would also be available for MIPS APMs reporting through the CMS Web Interface (except in cases where measures are entered manually into the CMS Web Interface). Specifically, MIPS eligible clinicians who report via qualified registries, QCDRs, EHR submission mechanisms, and CMS Web Interface in a manner that meets the end-to-end reporting requirements may receive one bonus point for each reported measure with a cap as described. We did not propose to allow this option for claims submission, because there is no mechanism for MIPS eligible clinicians to identify the information was pulled using an EHR. This approach supports and encourages innovative approaches to measurement using the full array of standards ONC adopts, and the data elements MIPS eligible clinicians capture and exchange, to support patient care. Thus, approaches where a qualified registry or QCDR obtains data from a MIPS eligible clinician's CEHRT using any of the wide range of ONC-adopted standards and then uses automated electronic systems to perform aggregation, calculation, filtering, and reporting would qualify each such measure for the CEHRT bonus point. In addition, measures submitted using the EHR submission mechanism or the EHR submission mechanism through a third party would also qualify for the CEHRT bonus.
We requested comment on this proposed approach.
The following is a summary of the comments we received regarding our proposal to award CEHRT bonus points for end-to-end electronic submissions.
We recommend and encourage all registries to pursue standards-based, fully electronic methods for accurately extracting and importing data from other electronic sources, in addition to data supported by CEHRT and other ONC-Certified Health IT, as appropriate to their measures. However, we recognize that for some types of measures some supplementation of the data normally recorded in EHRs in the course of care may in the near future still require registries to continue alternate, including manual, means of harvesting the data elements not yet practically available using electronic means. In future years, we anticipate evolving data standards and data aggregation and management services infrastructure, including robust registries capable of seamlessly aggregating and analyzing data across multiple electronic types and sources, will eventually eliminate the burden of manual processes including abstraction.
Any submission pathway that involves manual abstraction and re-entry of data elements that are captured and managed using certified health IT is not end-to-end electronic quality reporting and is not consistent with the goal of bonus. Thus, the bonus points would not apply to measures entered manually into the CMS Web Interface, though those measurements would be included in the MIPS eligible clinician's scoring for the performance category.
We do not believe limiting the bonus points to the relatively small number of measures that we will be able to accept directly from CEHRT for the 2017
After consideration of the comments, we are finalizing at § 414.1380(b)(1)(xiv) one bonus point is available for each measure submitted with end-to-end electronic reporting for a quality measure under certain criteria described in this section. We are modifying the CEHRT bonus cap. Specifically, we are increasing the cap for using CEHRT for end-to-end reporting from 5 percent to 10 percent of the denominator of the quality performance category (total possible points for the quality performance category) for the first 2 years. We intend to decrease this cap in future years through future notice and comment rulemaking. MIPS eligible clinicians will be eligible for both the CEHRT bonus option and the high priority bonus option with separate bonus caps for each option. The CEHRT bonus will be available to all submission mechanisms except claims submissions.
We are finalizing that the CEHRT bonus would be available to all submission mechanisms except claims submissions. Specifically, MIPS eligible clinicians who report via qualified registries, QCDRs, EHR submission mechanisms, and CMS Web Interface in a manner that meets the end-to-end reporting requirements may receive one bonus point for each reported measure with a cap as described. For Web Interface users, we define end-to-end electronic reporting as cases where users upload data that has been electronically exported or extracted from EHRs, electronically calculated, and electronically formatted into a CMS-specified file that is then electronically uploaded via the Web Interface as opposed to cases where measures are entered manually into the CMS Web Interface.
Due to requests from many commenters that we provide more clarity around the various options for a MIPS eligible clinician to satisfy the “end-to-end electronic” requirements and to earn the CEHRT bonus points, we are providing additional explanation regarding the final policy.
There are several key steps common across all of the submission pathways for end-to-end electronic reporting: (1) The collection of data at the point of care; (2) calculation of CQM performance as a numerator/denominator ratio; and (3) submission of the data to CMS using a standard format. ONC's certification regulations (45 CFR 170.315(c)(1) through (3) in the 2015 edition) have established several independent but complementary quality measurement capability criteria to which health IT modules can be certified because some health IT may not support all of the steps in the measurement process. For example, one application may support capturing the clinical data at the point of care (step 1), but not the calculation of measure results (step 2) or reporting of them to payers like CMS (step 3). Instead, that application may be built to export the measurement data in standard format to another application that performs the calculation and reporting functions but may not support initial data capture provide that feature. Some health IT applications are capable of performing each step necessary from data capture to CMS submission.
Although certification for each of these steps helps to ensure accurate calculation and reporting measures, our final policy seeks to offer MIPS eligible clinicians the opportunity to earn bonus points for a wider array of measurement pathways rather than the EHR submission method currently available only for eCQMs for which a health IT product, service, or registry could be certified under ONC's Health IT Certification Program as being in conformance with CMS-published specifications. At this time, we believe it is important to ensure incentives are tied to a wider array of submission pathways that facilitate automated, electronic reporting.
However, we continue to believe that standards-based, interoperable methods for managing quality measurement data are essential for both improving the value of measures to eligible clinicians while reducing these clinicians' data-handling burdens.
In a 2014 concept paper,
Table 18, summarizes at a high level several pathways we expect to be widely available to MIPS eligible clinicians in 2017 and 2018 for quality performance reporting and which of these pathways would earn bonus points for use of CEHRT to report quality measures electronically from capture to CMS (“end-to-end”).
In the first example in Table 18, for MIPS eCQMs, when a MIPS eligible clinician wishes to use CEHRT for the entire process of data capture to CMS submission, the health IT solution must be certified to § 170.315(c)(1) through (3) in order to achieve the bonus point.
In the second and third examples, the MIPS eligible clinician has chosen to participate in a registry or QCDR and report eCQMs. This MIPS eligible clinician sends quality data electronically from CEHRT to the registry, and the registry calculates the measure results and eventually submits the eCQMs data to CMS on the eligible clinician's behalf. In the second case, the registry uses health IT that is certified to § 170.315(c)(2) through (3) in order for the MIPS eligible clinician to earn the bonus points for end-to-end electronic reporting. In the third case, the QCDR does not use health IT that is certified to a particular standard, but uses automated, verifiable software to process data, calculate and electronically report a MIPS eCQM to MIPS consistent with CMS-vetted protocols. In both of these cases, a MIPS eligible clinician or group would earn a bonus point for each measure submitted in this manner, up to a 10 percent cap.
In both the fourth and fifth examples, the MIPS eligible clinician has chosen to participate in a QCDR and report on the MIPS-accepted non-MIPS (registry) measures. The MIPS eligible clinician uses CEHRT, and perhaps some additional certified health IT modules, in the normal course of clinical documentation and this certified health IT captures clinical data needed for the MIPS eligible clinician's selected registry measures. In both the fourth and fifth examples, the QCDR has satisfied the MIPS criteria, including obtaining CMS' approval of the non-MIPS measures this MIPS eligible clinician is using. In these cases, the QCDR processes the clinical data to calculate measure results and reports the MIPS-approved non-MIPS measures consistent with CMS-vetted protocols. The only difference between these two examples is how the data gets from the MIPS eligible clinician's certified health IT to the QCDR. In the fourth example, the MIPS eligible clinician's certified health IT transmits quality data documents to the registry in QRDA or other Clinical Document Architecture standard format. In the fifth example, the MIPS eligible clinician has made appropriate arrangements to grant the registry access to the quality measurement information via a secure application programming interface (API). We have presented both examples to emphasize that the MIPS eligible clinician would receive the bonus point under each scenario. Either the secure transmission of data within CDA documents or a secure API is an electronic method of managing and moving the quality measurement data to where it is needed.
In the sixth example, the group, or a third party submitting data on their behalf, may use the CMS Web Interface to submit electronic data for quality measure submissions. However, such a submission would only be awarded the bonus for end-to-end reporting if the submission included uploading an electronic file without modification. This is to preserve the electronic flow of data end-to-end and provide a verifiable method to ensure that manual abstraction, manual calculation, or subsequent manual correction or manipulation of the measures using abstraction did not occur.
Finally, in the last example, the MIPS eligible clinician initially captures data electronically, but manually abstracts the data for analysis and keys it into a web portal used by a registry. The registry then calculates and submits the measure results to CMS electronically. In this case, no bonus point would be given as the manual abstraction process interrupted the complete end-to-end electronic data flow.
The next two subsections provide a detailed description of how the quality performance category score would be calculated under our finalized policies.
To calculate the quality performance category score, we proposed to sum the weighted points assigned for the measures required by the quality performance category criteria plus the bonus points and divide by the weighted sum of total possible points. (81 FR 28256)
If a MIPS eligible clinician elects to report more than the minimum number of measures to meet the MIPS quality performance category criteria, then we would only include the scores for the measures with the highest number of assigned points. In the proposed rule (81 FR 28257), we provided an example for how this logic would work. The quality performance category score would be capped at 100 percent.
We proposed that if a MIPS eligible clinician has met the quality performance category submission criteria for reporting quality information, but does not have any scored measures as discussed in section II.E.6.b.(2) of the proposed rule, then a quality performance category score would not be calculated. Refer to section II.E.6.a.2.d. of the proposed rule (81 FR 28254) for details on how we proposed to address scenarios where a quality performance category score is not calculated for a MIPS eligible clinician. We requested comment on our proposals to calculate the quality performance category score.
The following is summary of the comments we received on our proposals to calculate the quality performance category score.
After consideration of the comments, we are finalizing our policy at § 414.1380(b)(1)(xv) to calculate the quality performance category score as proposed. We will sum the points assigned for the measures required by the quality performance category criteria plus the bonus points and divide by the weighted sum of total possible points. The quality performance category score cannot exceed the total possible points for the quality performance category. If a MIPS eligible clinician elects to report more than the minimum number of measures to meet the MIPS quality performance category criteria, then we will only include the scores for the measures with the highest number of assigned points, once the first outcome measure is scored, or if an outcome measure is not available, once another high priority measure is scored.
We are finalizing our proposal that if a MIPS eligible clinician does not have any scored measures, then a quality performance category score will not be calculated. However, we also note that during the transition year, with the implementation of the 3-point floor for class 2 measures as described in Table 17 that all MIPS eligible clinicians who are non-CMS Web Interface users, that submit some quality data will have a quality performance category score in year 1 of MIPS. The MIPS eligible clinician will receive:
• 3 points for submitted measures that do not meet the minimum case size, do not have a benchmark or do not meet data completeness criteria, even if the measure is reported with a 0 percent performance rate.
• 3 points or more for submitted or calculated measures that meet the minimum case size, have a benchmark and meet data completeness criteria, even if the measure is reported with a 0 percent performance rate.
However, as we will illustrate below, because we have changed the performance standards, submission criteria, and other scoring elements, we believe the scoring system will be simpler to understand and that it will reduce burden on MIPS eligible clinicians trying to achieve a higher quality performance category score. Thus, based on public comments, we are adjusting multiple parts of our proposed scoring approach to ensure that we do not unfairly penalize MIPS eligible clinicians who have not had time to prepare adequately to succeed under our proposed approach while still rewarding high performers.
For example, we are no longer requiring a cross-cutting measure for patient facing MIPS eligible clinicians, as discussed in section II.E.5.(b)(3) of this final rule with comment period. Additionally, we are no longer requiring two of the 3 population health measures and are only requiring the all-cause hospital readmission measure for groups of 16 or more clinicians instead of our proposed approach of groups of 10 or more, assuming the case minimum of 200 cases has been met, as discussed in section II.E.5.b.(6) of this final rule with comment period. If the case minimum of 200 cases has not been met, we will not score this measure. Thus, the MIPS eligible clinician will not receive a zero for this measure, but rather this measure will not apply to the MIPS eligible clinician's quality performance category score.
We also note that if a group of 16 or more, does not report any quality performance category data, the group would be scored on the all-cause readmission measure (assuming the group meets the readmission measure minimum case size requirements) even if they did not submit any other quality performance category measures if they submitted information in other performance categories. If a group of 16 or more did not report any information in any of the performance categories, then the readmission measure would not be scored.
We are now capping both the high priority bonus and the CEHRT bonus at 10 percent instead of 5 percent of the denominator of the quality performance category score. Further, all measures reported can now be scored with a floor of 3 points even if the measure is below the case minimum, lacks a benchmark or is below the completeness requirement. We believe that all of these modified elements, when combined, will significantly increase participation in the MIPS, will reduce burden and confusion on MIPS eligible clinicians and will allow MIPS eligible clinicians to gain experience under the MIPS while penalties are smaller in nature.
For example, a MIPS eligible clinician who is in a group of 20 practitioners that reports as a group, and reports 4 quality measures instead of the required 6 measures. Of the 4 measures submitted, which include an outcome measure, each measure has a performance rate that is low. The clinician is also scored on an additional measure, the all-cause hospital readmission measure, but has a poor performance rate on this measure as well. Under this revised scoring approach, we allow all MIPS eligible clinicians who submit quality measures to receive a 3-point floor per measure in the quality performance category. Under this scenario, the MIPS eligible clinician receives the 3-point floor for each of the 4 submitted measures and the all-cause hospital readmission measure. The MIPS eligible clinician's quality performance category weighted score is calculated as follows: 5 measures × 3 points each/total possible points of 70 points × (quality performance category weight of 60) = 12.9 points towards the final score.
In another example, a MIPS eligible clinician who is a solo practitioner reports all 6 measures, including an outcome measure, although all are
In another example, a MIPS eligible clinician is in a group of 25 that reports as a group via registry 3 process measures, 1 outcome measure, 1 other high priority (for example, patient safety) measure and 1 process measure that is below the case minimum requirement. Two of the process measures and one outcome measure qualify for the CEHRT bonus. Measures that do not meet the required case minimum or do not have a benchmark or fall below the data completeness requirement will be given 3 points. We emphasize that these measures are treated differently than a required measure that is not reported. Any required measure that is not reported would receive a score of zero points and be considered a scored measure. Table 19 illustrates the example.
The total possible points for the MIPS eligible clinician is 70 points. The eligible clinician has 49.9 points based on performance. The MIPS eligible clinician also qualifies for 1 bonus point for reporting an additional high priority patient safety measure and 3 bonus points for end-to-end electronic reporting of quality measures. The bonus points for high priority measures and CEHRT reporting are subject to two separate caps, which are each 10 percent of 70 possible points or 7 points. The quality performance category score for this MIPS eligible clinician is (49.9 points + 4 bonus points = 53.9)/70 total possible points × 60 (quality performance category weight) = 46.2 points towards the final score. The quality performance category score would be capped at 100 percent.
The example in Table 20 illustrates how to calculate the bonus cap for the high priority measure bonus and the CEHRT bonus. In this scenario, the MIPS eligible clinician is a solo practitioner who has submitted 6 measures, as an individual, all above the case minimum requirement. Since the MIPS eligible clinician is a solo practitioner, the all-cause hospital readmission measure does not apply. The MIPS eligible clinician below successfully submitted six quality measures using end-to-end electronic reporting, and therefore, qualifies for the CEHRT bonus of one point for each of those measures. In addition to CEHRT bonus points, the MIPS eligible clinician reported 4 outcome measures (6 bonus points), a patient experience measure (2 bonus points) and a care coordination measure (1 bonus point) for 9 total high priority bonus points. The MIPS eligible clinician receives 2 bonus points for the second, third and fourth outcome measures, given that no bonus points are given for the first required measure. However, the number of high priority measure bonus points (9 points) is over the cap (which is 10 percent of 60 possible points or 6 points), and the number of CEHRT bonus points (6 points) is at the cap (which is 10 percent of 60 possible points or six points). The quality performance category score for this MIPS eligible clinician is 50.8 + 6 CEHRT bonus points + 6 high priority bonus points/60 points = 62.8/60 or 100 percent since the overall number of points is capped at 60 or 100 percent score. Note, in section II.E.5.b.(2) of this final rule with comment period, we proposed to weight the quality performance category at 60 percent of the MIPS final score, so a 100 percent quality performance category score would account for 60 percent of the final score.
CMS Web Interface reporters have different quality performance category submission criteria; therefore, we proposed to modify our scoring logic slightly to accommodate this submission mechanism. CMS Web Interface users report on the entire set of measures specified for that mechanism. Therefore, rather than scoring the top six reported measures, we proposed to score all measures. If a group does not meet the reporting requirements for one of the measures, then the group would receive 0 points for that measure. We note that since groups reporting through the CMS Web Interface are required to report on all measures, and since some of those measures are “high priority,” these groups would always have some bonus points for the quality performance category score if all the measures are reported. That is, the group would either report on less than all CMS Web Interface measures, in which case the group would receive zeroes for unreported measures, or the group would report on all measures, in which case the group would automatically be eligible for bonus points. The other proposals for scoring discussed in section II.E.6.a.2.(g)(i) of the proposed rule, including bonus points, would still apply for CMS Web Interface. We requested comment on this proposal.
The following is a summary of the comments we received regarding our proposal to score CMS Web Interface.
After considering all comments, we are finalizing our policy as proposed with regard to scoring CMS Web
We also highlight that unless otherwise noted, this section on CMS Web Interface scoring will not apply to clinicians participating in an APM Entity scored through the APM scoring standard. APM Entity group reporting and scoring for MIPS eligible clinicians participating in MIPS APMs are summarized in section II.E.5.h. of this final rule with comment period. All eligible clinicians that participate in APMs are considered MIPS eligible clinicians unless and until they are determined to be either QPs or Partial QPs who elect not to report under MIPS, and are excluded from MIPS, or unless another MIPS exclusion applies.
We are finalizing the following modifications for our CMS Web Interface scoring policies. First, we will be providing a global floor of 3 points for all CMS Web Interface measures submitted in the transition year, even with measures at 0 percent performance rate, assuming that these measures have met the data completeness criteria, have a benchmark and meet the case minimum requirements. However, measures with performance below the 30th percentile will be assigned a value of 3 points during the transition year to be consistent with the floor established in this rule for other measures and because the Shared Savings Program does not publish benchmarks below the 30th percentile. We will reassess scoring for measures below the 30th percentile in future years. Table 22 illustrates how the decile score works for Shared Saving Program benchmarks. For example, a performance rate of 9.6 percent (below 30th percentile), would receive 3.0 points. This methodology will not affect the scoring for MIPS eligible clinicians with performance in the third decile or higher. In addition, this methodology will not affect the calculation of future benchmarks.
We will not score CMS Web Interface measures that do not meet the case minimum requirement or lack a benchmark unless that measure is not submitted. We believe that this policy is appropriate since, unlike with non-CMS Web Interface users where MIPS eligible clinicians can report additional measures beyond the required six to ensure that there are sufficient measures to be scored on performance, CMS Web Interface users are limited to reporting the 14 measures (13 individual measures and the 2-component diabetes composite measure) listed in Table 21. Given that these CMS Web Interface users cannot report additional measures in instances where a measure does not have a benchmark or is below the case minimum, we have decided not to score these measures.
However, measures that are not reported and measures reported below the data completeness requirements will receive a 0 score. We have decided to give a zero to measures that are below the data completeness requirements for CMS Web Interface users because we believe that these users generally have more experience in reporting measures than the non-CMS Web Interface users and therefore should not have any challenges in meeting the data completeness criteria. Table 23 summarizes the scoring approach for Web Interface and Non-Interface Measures.
We provide in Table 24 examples of this scoring approach. For example, for each measure that lacks a benchmark that is not reported, a zero will be added to the numerator and 10 points will be added to the denominator. This is because normally these measures are not scored but since these measures were not reported, the group will be penalized with a lower quality performance category score accordingly. For each measure that does not lack a benchmark that is not reported, then a zero will be added to the numerator but no points will be added to the denominator since these measures are normally scored so the denominator is static. We are finalizing the policy to score measures with benchmarks because CMS Web Interface reporters have to report on more than 6 measures, so we believe we have a comparable number of measures compared to other reporting mechanisms. In addition, we believe this policy to not score measures without a benchmark is consistent with Shared Savings Program and NextGen ACO programs which do not measure performance on selected measures.
Section 1848(q)(3)(B) of the Act requires the Secretary, in establishing performance standards for measures and activities for the MIPS performance categories, to consider: historical performance standards; improvement; and the opportunity for continued improvement. In addition, under section 1848(q)(5)(D) of the Act, beginning with the second year of the MIPS, if data sufficient to measure improvement are available, the final score methodology shall take into account improvement of the MIPS eligible clinician in calculating the performance score for the quality and cost performance categories and may take into account improvement for the improvement activities and advancing care information performance categories.
We solicited public comments on potential ways to incorporate improvement into the scoring methodology moving forward. We were especially interested in feedback on the following three options, with the assumption that eligible clinicians would report the same measures year-to-year (where possible). We were also interested in feedback on how to score improvement given that a MIPS eligible clinician can change measures and submission mechanisms from year-to-year. In addition, a MIPS eligible clinician can elect to report as an individual or a member of a group and that election can vary from year to year. Finally, we sought feedback on whether to score improvement where MIPS eligible clinicians do not have the required case minimum for measures to be scored.
We appreciate the comments regarding the three proposed options to score improvement; however, we are not proposing an approach for scoring improvement at this time. We will consider these comments and outline a proposal in future rulemaking.
As we described in the proposed rule (81 FR 28259), we proposed to align scoring across the MIPS performance categories. For the cost performance category, we proposed to score the cost measures similarly to the quality performance category. Specifically, we proposed at § 414.1380(b)(2) to assign one to ten points to each cost measure based on a MIPS eligible clinician's performance compared to a benchmark (81 FR 28260). However, we proposed that for the cost performance category (unlike the quality performance category), the benchmark would be based on the performance period, rather than the baseline period. The details of the scoring for cost measures are described below.
For the cost performance category, we proposed at § 414.1380(b)(2) that the performance standard is measure-specific benchmarks (81 FR 28259). We would calculate an array of measure benchmarks based on performance. Then, a MIPS eligible clinician's actual performance on the cost measure during the performance period would be evaluated to determine the number of points that should be assigned based on where the clinician's actual performance falls within these benchmarks.
We proposed at § 414.1380(b)(2) to create benchmarks for the cost measures based on the performance period (81 FR 28260). Changes in payment policies, including changes in relative value units, and changes that affect how hospitals, clinicians and other health care providers are paid under Medicare Parts A and B, can make it challenging to compare performance on cost measures in a performance period with a historical baseline period. In addition, for the Hospital VBP Program and the VM, we use the performance period to establish the benchmarks for scoring Hospital VBP Program's efficiency measures and the VM's cost measures (80 FR 49562, 80 FR 71280). We proposed that if we use the performance period, we would publish the benchmark methodology in a final rule, but would not be able to publish the actual numerical benchmarks in advance of the performance period. We stated we believe that it is important for MIPS eligible clinicians to know in advance how they might be scored so we would continue to provide performance feedback with information on the MIPS eligible clinician's relative performance.
We considered an alternative to base the cost performance category measure benchmarks on the baseline period proposed rather than the performance period (81 FR 28259). This option would further align the cost performance category benchmark methodology with the quality performance category benchmark methodology. This option would also allow us to publish the numerical benchmarks before the performance period ends; however, we believe the benefits of earlier published benchmarks are more limited for cost measures. MIPS eligible clinicians would not be able to track their daily progress because they would not have all the necessary information to determine the attribution, price standardization, and other adjustments to the measures. We believe the relative performance that we provide through performance feedback would provide MIPS eligible clinicians the information they need to track performance and to learn about their resource utilization. In addition, we believe that using benchmarks based in the performance period is a better approach than using benchmarks based in the baseline period because different payment policies could apply during the baseline period than during the performance period which could affect the cost of care for patients treated by MIPS eligible clinicians. We would also have to identify the baseline benchmark and trend it forward so that the dollars in the baseline period are comparable to the performance period, whereas we would not have to make a trending adjustment for benchmarks based on the performance period. For these reasons, we elected to propose to base the benchmarks on the performance period rather than the baseline period.
We proposed to create a single set of benchmarks for each measure specified for the cost performance category. We proposed that all MIPS eligible clinicians that are attributed sufficient cases for the measure would be included in the same benchmark. In addition, we proposed that a minimum of 20 MIPS eligible clinicians or groups must be attributed the case minimum in order to develop the benchmark. If a measure does not have enough MIPS eligible clinicians or groups that are attributed enough cases to create a benchmark, then we proposed not including that measure in the scoring for the cost performance category.
We requested comment on the proposal to establish cost measure benchmarks based on the performance period as well as the alternative proposal.
The following is a summary of the comments we received regarding our proposals on the benchmarking of cost measures:
We also believe that it is appropriate to have a national versus regional benchmark. The cost measures are price standardized to remove geographic adjustments such as wage indices and cost of living adjustments, so that measures would reflect the same payment rate for a particular service regardless of the region in which it is provided. Other CMS performance programs such as VM and HVBP use national benchmarks and we believe it is appropriate to continue that policy for MIPS. After considering the comments, we are finalizing our proposals at § 414.1380(b)(2) to establish a single benchmark for each cost measure and to base those benchmarks on the performance period. We are finalizing the methodology proposed at § 414.1380(b)(2) to assign one to ten points to each cost measure attributed to the MIPS eligible clinician based on the MIPS eligible clinician's performance compared to the measure benchmark. Because we are basing the benchmarks on the performance period, we will not be able to publish the actual numerical benchmarks in advance of the performance period, as indicated in the proposed rule (81 FR 28259).
While we understand there are some opportunities associated with benchmarking to a previous year, we believe they are overwhelmed by the disadvantages. This is particularly true as we continue to develop episode-based measures in which the development of a new technology or a change in payment policy could result in a significant change in typical cost of care from year to year. This could potentially result in the majority of clinicians being found to perform well above or well below the benchmark, even if they did not change their practice patterns in relation to their peers. While we did not receive any comments on our proposal to only develop a benchmark for a measure if a minimum 20 MIPS eligible clinicians or groups are attributed the case minimum, we are finalizing that proposal incorporating the changes made to the attribution methodology used for cost measures discussed in II.E.5.e.(3) of this final rule with comment period. We will develop a benchmark for a measure only if at least 20 groups (for those MIPS eligible clinicians participating in MIPS as a group practice) or TIN/NPI combinations (for those MIPS eligible clinicians participating in MIPS as an individual) can be attributed the case minimum for the measure. We are also finalizing our proposal that if a benchmark is not developed, the measure is not scored or included in the performance category.
For each set of benchmarks, we proposed to calculate the decile breaks based on measure performance during the performance period and assign points for a measure based on which benchmark decile range the MIPS-eligible clinician's performance on the measure is between. We proposed that for cost measures, lower costs represent better performance. In other words, MIPS-eligible clinicians in the top decile would have the lowest cost of care. We proposed to use a methodology generally consistent with the methodology proposed for the quality performance category. We refer readers to Tables 21 and 22 of the proposed rule (81 FR 28260 through 28261), for details on assigning points based on decile distribution. We requested comments on the methodology for assigning points based on performance period deciles for the cost performance category and solicited comments on alternative methodologies for assigning points for performance under this performance category for future rulemaking.
For clarity, we have reproduced Table 21 from the proposed rule in Table 25. Table 25 illustrates an example of using decile points along with partial points to assign achievement points for a sample cost measure.
The following is summary of the comments we received regarding our proposal to assign points for a measure based on performance period deciles for the cost performance category.
After considering the comments, we are finalizing our proposal to assign 1 to 10 achievement points for each measure based on which benchmark decile range the MIPS eligible clinician's performance on the measure is between.
We seek to ensure that MIPS eligible clinicians are measured reliably; therefore, we proposed in section II.E.5.e.(3) (81 FR 28198) of the proposed rule, to establish a 20 case minimum for each cost measure. We noted that this would include the MSPB measure. In the CY 2016 PFS final rule, we finalized a policy that increases the required case minimum for MSPB from 20 to 125 cases (80 FR 71295 through 71296). As discussed further in section II.E.5.e.(3)(a)(ii) of this final rule with comment period, after considering the comments and reviewing additional data sources, we finalized a higher case minimum of 35 for a MIPS eligible clinician or group to be attributed the MSPB cost measure. This newly established case minimum of 35 will ensure that the measure meets our reliability threshold for both groups and individual clinicians. We finalized a case minimum of 20 for all other cost measures and finalized at § 414.1380(b)(2)(ii) that MIPS eligible clinicians and groups must meet the minimum case volume specified by CMS to be scored on a cost measure for the cost performance category for the clinician or group.
To calculate the cost performance category score, we proposed at § 414.1380(b)(2)(iii) to average all the scores of all the cost measures attributed to the MIPS eligible clinician. All measures in the cost performance category as described in section II.E.5.e. of the proposed rule would be weighted equally. If a MIPS eligible clinician has only one cost measure with a required case minimum to be scored, we proposed to score that measure accordingly, and the MIPS eligible clinician's cost performance category score would consist of the score for that one measure. We noted that MIPS eligible clinicians cannot receive a zero score for any cost measure for failure to submit the measure since none of the cost performance category measures are submitted by MIPS eligible clinicians. Rather, these measures are attributed to MIPS eligible clinicians through claims data. However, if a MIPS eligible clinician is not attributed any cost measures (for example, because the case minimum requirements have not been met for any measure or there is not a sufficient number of MIPS eligible clinicians to create a benchmark for any measure), then a cost performance category score would not be calculated. Refer to section II.E.6.b.(2) of this final rule with comment period for details on how we address scenarios where a performance category score is not calculated for a MIPS eligible clinician. MIPS eligible clinicians would receive performance feedback as required under section 1848(q)(12) of the Act and discussed in section II.E.8.a. of this final rule with comment period. Over time, performance feedback may include a list of attributed cases for each measure by MIPS eligible clinician. We requested comment on our proposals to calculate the cost performance category score.
Table 22 of the proposed rule illustrated a sample scoring methodology for a limited set of measures (81 FR 28261). Measures that do not meet the required case minimum are not used for scoring. Unlike the quality performance category score, we did not propose bonus points as part of the cost performance category score. The following is summary of the comments we received regarding our proposed calculation of the cost performance category score:
We also understand that there are cases in which an individual clinician or group might have the same individual patient costs attributed for multiple cost measures. However, we do not believe that this justifies limiting the number of measures in the cost performance category score for a particular clinician or group. In the quality performance category, if a clinician submits more measures than required, we will only include those with the highest score in the performance category score. We do this in part to encourage quality reporting on new and diverse measures. Because cost measures do not require reporting, we do not believe this rationale applies for the cost performance category. We will use all cost measures that meet the case minimums in calculating the cost performance category score, as long as those measures have also met our standards for the minimum number of attributed clinicians or groups needed to calculate a benchmark.
After consideration of the comments, we are finalizing our proposal at § 414.1380(b)(2)(iii) that a MIPS eligible clinician's cost performance category score is the equally-weighted average of all scored costs measures. We are also finalizing our proposal to not calculate a cost performance category score if a clinician or group is not attributed any cost measures, because the clinician or group has not met the case minimum requirements for any of the cost measures or a benchmark has not been created for any of the cost measures that would otherwise be attributed to the clinician or group. As described in section II.E.5.e.(2) of this final rule with comment period, we are finalizing a 0 percent weight for the cost performance category for the transition year of MIPS, a 10 percent weight for MIPS payment year 2020. For MIPS payment year 2021 and beyond, the cost performance category will be 30 percent. This reduced weighting provides an opportunity for MIPS eligible clinicians to become familiar with the scoring in the cost performance category of MIPS.
Section 1848(q)(5)(C) of the Act outlines specific scoring rules for the improvement activities performance category. Section 1848(q)(5)(C)(i) of the Act provides that a MIPS eligible clinician who is in a practice that is a certified patient-centered medical home or comparable specialty practice for a performance period shall receive the highest potential score for the improvement activities performance category for such period. Section 1848(q)(5)(C)(ii) of the Act provides that MIPS eligible clinicians participating in an APM for a performance period shall earn a minimum score of one-half of the highest potential score for the improvement activities performance category for such period. We refer readers to section II.E.5.h. of this final rule with comment period for a description of the APM scoring standard for MIPS APMs. Section 1848(q)(5)(C)(iii) of the Act states that MIPS eligible clinicians are not required to perform activities in each subcategory or participate in an APM to receive the highest possible score for the improvement activities performance category. Based on these criteria, we proposed a scoring methodology that assigns points for the improvement activities performance category (based on certified patient-centered medical home participation and the improvement activities reported by the MIPS eligible clinician). A MIPS eligible clinician's performance would be evaluated by comparing the reported improvement activities to the highest possible score.
Improvement activities is a new performance category that has not been implemented in our previous programs. Therefore, in the transition year, we cannot assess how well the MIPS eligible clinician has performed on the activity against data from a baseline year. We can only assess whether the MIPS eligible clinician has participated sufficiently to receive credit in the improvement activities performance category. Therefore, we proposed at § 414.1380(b)(3) to assign points for each reported activity within two categories: Medium-weighted and high-weighted activities (81 FR 28261). Medium-weighted activities are worth 10 points. High-weighted activities are worth 20 points. Table 26 under section II.E.6.a(4)(a) of this final rule with comment period lists all of the improvement activities that are high-weighted. All other activities not listed as high-weighted activities are considered medium activities. Table H in the Appendix of this final rule with comment period provides the Improvement Activities Inventory of all activities, both medium-weighted and high-weighted. Consistent with our unified scoring system principles, MIPS eligible clinicians would know in advance how many potential points they could receive for each improvement activity.
Activities are proposed to be weighted as high based on the extent to which they align with activities that support the certified patient-centered medical home, since that is the standard under section 1848(q)(5)(C)(i) of the Act for achieving the highest potential score for the improvement activities performance category, as well as with our priorities for transforming clinical practice. Additionally, activities that require
We also considered an approach of equal weighting for all improvement activities. We solicited comment on a multi-tier weighting approach such as low, medium and high activity categories for future years of MIPS.
The following is a summary of the comments we received regarding our proposal on the assigning of points to reported improvement activities.
After consideration of the comments, we are finalizing our proposals at § 414.1380(b)(3) to assign points for improvement activities according to two weightings: Medium-weighted; and high-weighted activities. Each medium-weighted activity is worth 10 points toward the total category score, and each high-weighted activity is worth 20 points toward the total category score of 40 points. These points are doubled for small practices, rural practices, or practices located in geographic health professional shortage areas (HPSAs), and non-patient facing MIPS eligible clinicians. We refer readers to section II.E.6.a.(4)(d) of this final rule with comment period for further detail on improvement activities scoring.
We are finalizing Table 23 of the proposed rule (81 FR 28263) with modifications that include clarifying language for one of the existing PDMP activities that is assigned the highest points for an activity (20 points), revising the description of one existing activity under the Emergency Response and Preparedness Subcategory that is also assigned the highest points for an activity (20 points) and changing the period for this activity to be performed from a minimum of 6 months to 60 days, which is better aligned with the new overall performance period for the Quality Payment Program of a 90-day reporting period, and we are changing the weighting of one existing activity in the Population Management subcategory from medium-weighted and instead assigning it the highest points for an activity (20 points). We are changing this existing activity from a medium to a high-weighted activity to incentivize caring for these vulnerable populations. These modifications are reflected in Table 26, which lists the improvement activities that are assigned the highest points for an activity (high-weighted activities are double-weighted to 40 points for MIPS eligible clinicians that are small practices, practices located in rural areas, geographic HPSAs, or non-patient facing MIPS eligible clinicians and 20 points for all other MIPS eligible clinicians). Table H in the Appendix to this final rule with comment period provides the Improvement Activities Inventory of all activities, both medium-weighted and high-weighted.
Although there is likely to be variability in the level at which each MIPS eligible clinician may perform improvement activities, we currently do not have a standard way of measuring that variability. In future years, we plan to capture data to begin to develop a baseline for measuring improvement in performing improvement activities. Because we cannot measure variable performance within an improvement activity at this time, we proposed at § 414.1380(b)(3)(v) to compare the points associated with the reported activities against the highest potential score (81 FR 28265). We proposed the highest potential score to be 60 points for the transition year performance period based on the following rationale.
Based on discussions with several high performing organizations, we believed that MIPS eligible clinicians would be able to report on as many as six activities of medium weight. Examples of these organizations include one that led a major redesign of patient workflow after Hurricane Katrina, implementing clinical practice improvements to ensure patients receive faster treatment in the event of future disasters, ranked nationally in six adult specialties and high-performing in six adult specialties;
We also believed that a top performing small practice or practice in a rural area or geographic HPSA, or a non-patient facing MIPS eligible clinician would be able to report on at least two activities. In consideration of special circumstances for these small practices, as well as practices located in rural areas and in HPSAs or non-patient facing MIPS eligible clinicians, we proposed that the weight for any activity selected would be 30 points. For any MIPS eligible clinician, the maximum total points achievable in this performance category is 60 points. Based on the above rationale, we believed it was reasonable to expect all MIPS eligible clinicians to be able to report improvement activities, and as such, a MIPS eligible clinician reporting no improvement activities would receive a zero score for the improvement activities performance category. We believed this proposal would allow us to capture variation in reporting the improvement activities performance category.
Section 414.1355(a) of the proposed rule presented the CMS Study on Improvement Activities and Measurement (81 FR 28214). Given the burden for participants completing the year-long study and the value of collectively examining innovation and practice activities to improve clinical quality data submissions and further reduce time requirements for eligible clinicians and groups to report, we proposed that MIPS eligible clinicians and groups that successfully participate and submit data to fulfill study requirements would receive the highest potential score of 60 points for the improvement activities performance category.
The following is a summary of the comments we received regarding our proposal on the methodology for achieving the highest score.
All other MIPS eligible clinicians, other than a MIPS APM, will receive 10 points by selecting one medium-weighted activity (a medium-weighted activity is double-weighted for small practices, practices located in rural areas and geographic HPSAs, and non-patient facing MIPS eligible clinicians); 20 points by selecting two medium-weighted activities; 30 points by selecting three medium activities; and 40 points by selecting four medium-weighted activities. An APM, other than a MIPS APM, only needs to select two medium or one high-weighted activity to add to their automatic score of at least one-half of the highest score. Alternatively, these same MIPS eligible clinicians may receive 20 points by selecting one high-weighted activity (a high-weighted activity is double-weighted for small practices, practices located in rural areas and geographic HPSAs, and non-patient facing MIPS eligible clinicians), or 40 points by selecting two high-weighted activities. With the exception of small practices, practices in rural areas and geographic HPSAs and non-patient facing MIPS eligible clinicians, a combination of one medium-weighted activity and one high-weighted activity would achieve 30 points and two medium- and one high-weighted activity would achieve 40 points. MIPS eligible clinicians or
After consideration of the comments, we are not finalizing our proposal at § 414.1380(b)(3)(v) to compare the points associated with the reported activities against the highest potential score of 60 points but are using 40 points instead as the total points possible to achieve the highest score for the transition year performance period (81 FR 28265). For small practices, rural and geographic HPSA practices and non-patient facing MIPS eligible clinicians, the weight for any activity selected would be doubled so that these practices only need to select one high- or two medium-weighted activities to achieve the highest score of 40 points. We are finalizing our proposal that MIPS eligible clinicians participating in APMs will automatically receive one-half of the highest score for improvement activities and in addition, MIPS APMs may receive a higher score based on the improvement activities performance category score that CMS assigns for each MIPS APM based on the extent to which the requirements of the specific model meet the list of activities in the Improvement Activities Inventory. We note that one-half of the highest score for improvement activities is the minimum amount that eligible clinicians participating in APMs could achieve, in accordance with the statute. We refer readers to section II.E.5.h of this final rule with comment period for additional information about how a MIPS APM can achieve the highest score.
The following is a summary of the comments we received regarding our proposal to conduct the CMS Study on Improvement Activities and Measurement.
After consideration of the comments, we are finalizing our proposal that MIPS eligible clinicians and groups that successfully participate and submit data to fulfill study requirements will receive the highest score for the improvement activities performance category.
Section 1848(q)(5)(C)(i) of the Act specifies that a MIPS eligible clinician who is in a practice that is certified as a patient-centered medical home or comparable specialty practice, as determined by the Secretary, for a performance period must be given the highest potential score for the improvement activities performance category for the performance period. We proposed that certified patient-centered medical home practices are those that have received accreditation from any of the following four nationally recognized accreditation organizations the Accreditation Association for Ambulatory Health Care, the National Committee for Quality Assurance (NCQA), The Joint Commission, and the Utilization Review Accreditation Commission (URAC);
We outlined at § 414.1355(b) of the proposed rule the policy for certified patient-centered medical homes (81 FR 28209). The organizations identified above maintain a list of certified patient-centered medical homes, including the Medical Home Models and the Medicaid Medical Home Models, that would be used to determine whether a MIPS eligible clinician qualifies for the highest potential score for the improvement activities performance category because the MIPS eligible clinician is in a certified patient-centered medical home. The NCQA maintains a list of practices that have received the Patient-Centered Specialty Recognition which would be used to determine whether a MIPS eligible clinician qualifies for the highest potential score for the improvement activities performance category because the MIPS eligible clinician is in a comparable specialty practice.
We proposed at § 414.1380(b)(3) that a MIPS eligible clinician who is in a practice that is certified as a patient-centered medical home, including a Medical Home Model, Medicaid Medical Home Model or comparable specialty practice in accordance with those proposals would receive the highest potential score (in accordance with section 1848(q)(5)(C)(i) of the Act) of 60 points for the improvement activities performance category (81 FR 28210).
The following is summary of the comments we received regarding our proposal to provide practices defined as certified patient-centered medical homes with the highest score for the improvement activities performance category. We address comments
After consideration of these comments we are finalizing our proposal at § 414.1380(b)(3) that a MIPS eligible clinician who is in a practice that is certified as a patient-centered medical home, including a Medicaid Medical Home, Medical Home Model, or comparable specialty practice, will receive the highest potential score (in accordance with section 1848(q)(5)(C)(i) of the Act) for the improvement activities performance category (81 FR 28210). However, as noted in section II.E.5.f.(3)(b) of this final rule with comment period, we are not finalizing our proposal at § 414.1380(b)(3)(v) to compare the points associated with the reported activities against the highest potential score of 60 points (81 FR 28210), but instead are using 40 points as the total points required to achieve the highest score for the transition year performance period. We also are not finalizing our proposal at § 414.1355(b) to only define certified patient-centered medical home practices as those that have received accreditation from four nationally recognized accreditation organizations (the Accreditation Association for Ambulatory Health Care, the National Committee for Quality Assurance (NCQA), The Joint Commission, and the Utilization Review Accreditation Commission (URAC)); or comparable specialty practices as those that are a Medicaid Medical Home Model or Medical Home Model or from the NCQA Patient-Centered Specialty Recognition (81 FR 26210), rather we are finalizing an expanded definition of these practices at section II.E.5.f.(3)(b) of this final rule with comment period, and we refer readers to the specifics of this definition in section II.E.5.f.(3)(b) of this final rule with comment period.
To determine the improvement activities performance category score, we proposed to sum the points for all of the MIPS eligible clinician's reported activities and divide by the proposed improvement activities performance category highest potential score of 60. A perfect score would be 60 points divided by 60 possible points, which equals 100 percent. If MIPS eligible clinicians have more than 60 improvement activities points, then we proposed to cap the resulting improvement activities performance category score at 100 percent.
Table 24 of the proposed rule illustrated a sample scoring methodology for the improvement activities performance category for a MIPS eligible clinician that is not an APM participant (81 FR 28267). For example, the MIPS eligible clinician was not an APM participant and did not immediately earn the minimum score of one-half of the highest potential score or 30 points that are available for APM participation. The MIPS eligible clinician completed two high-weighted activities worth 20 points each and two medium-weighted activities for 10 points each to receive the maximum 60 points available in the improvement activities performance category score of 100 percent.
Alternatively, the MIPS eligible clinician could have selected three high-weighted activities for 20 points each, six medium-weighted activities for ten points each, or some combination to reach 60 points. The score however is capped at 100 percent (60/60). This means that a MIPS eligible clinician who selects four high-weight activities (80 possible points) would still be given a score of 100 percent (60/60). Please refer to Table 24 of the proposed rule for the illustration of the proposed methodology (81 FR 28267).
Section 1848(q)(2)(B)(iii) of the Act requires the Secretary to give consideration to the circumstances of small practices and practices located in rural areas and in geographic HPSAs (as designated under section 332(a)(1)(A) of the Public Health Service Act) in defining activities. Section 1848(q)(2)(C)(iv) of the Act also requires the Secretary to give consideration to non-patient facing MIPS eligible clinicians. Further, section 1848(q)(F)(5) of the Act allows the Secretary to assign different scoring weights for measures, activities, and performance categories, if there are not sufficient measures and activities applicable and available to each type of eligible clinician.
For MIPS eligible clinicians and groups that are small practices, practices located in rural areas, practices located in geographic HPSAs, or non-patient facing MIPS eligible clinicians or non-patient facing MIPS eligible clinician groups, we proposed alternative scoring requirements for the improvement activities performance category. The rationale for this alternative scoring is grounded in the resource constraints these MIPS eligible clinicians face which was further discovered during listening sessions with small, rural and geographic HPSAs and medical societies for non-patient facing MIPS eligible clinicians and groups. We believe that while non-patient facing MIPS eligible clinicians and non-patient facing groups could select activities from some sub-categories (such as care coordination and patient safety), for other sub-categories (such as beneficiary engagement and population
All MIPS eligible clinicians would be allowed to self-identify as a certified patient-centered medical home or comparable specialty practice, a non-patient facing MIPS eligible clinician, a small practice, a practice located in a rural area, or a practice in a geographic HPSA or any combination thereof as applicable during attestation following the performance period. We refer readers to
We would validate these self-identifications as appropriate. We proposed that the following scoring would apply to MIPS eligible clinicians who are a non-patient facing MIPS eligible clinician, a small practice (consisting of 15 or fewer professionals), a practice located in a rural area, or practice in a geographic HPSA or any combination thereof:
• Reporting of one medium-weighted or high-weighted activity would result in 50 percent of the highest potential score.
• Reporting of two medium-weighted or high-weighted activities would result in 100 percent of the highest potential score.
In future years, we may adjust the weighting of activities at the MIPS eligible clinician level based on initial patterns of improvement activities reporting. For example, if a MIPS eligible clinician reports on the same medium-weighted activity over several performance periods, in a subsequent year that MIPS eligible clinician may not be allowed to continue to select that same activity. This is because section 1848(q)(2)(C)(v)(III) of the Act provides that the intent of the improvement activities performance category is to demonstrate improvement over time and not just demonstrate same benefit from year to year. Specifically, the statute defines that an activity is expected, when effectively executed, to result in improved outcomes, which would be demonstrated over time. If a MIPS eligible clinician reports on the same activity from year to year that does not show improved outcomes, it would not be in line with the spirit of statute.
For example, continuing to provide expanded practice access year after year would not demonstrate improved outcomes over time. Further, should the weighting of activities change in future years, we may also adjust the improvement activities performance category point target accordingly. We requested comment on our proposed approach to score the improvement activities performance category, and solicited comment on alternative methodologies for the improvement activities performance category. We sought to assure equity in scoring MIPS eligible clinicians while still considering activity variation, impact and burden.
The following is summary of the comments we received regarding our proposal to calculate the improvement activities performance score.
After consideration of the comments, we are not finalizing our proposal to require achievement of 60 points to receive the highest score for the improvement activities performance category. Rather, we are only requiring a total of 40 points to receive the highest score for the improvement activities performance category. In alignment with the reduction in total points required, we are finalizing that the following scoring that will apply to MIPS eligible clinicians who are a non-patient facing clinician, a small practice, a practice located in a rural area, or practice in a geographic HPSA or any combination thereof:
• Reporting of one medium-weighted activity would result in 20 points or one-half of the highest score.
• Reporting of two medium-weighted activities would result in 40 points or the highest score.
• Reporting of one high-weighted activity would result in 40 points or the highest score.
In alignment with the reduction in total points required, we are finalizing the following scoring that will apply to MIPS eligible clinicians who are not a non-patient facing clinician, a small practice, a practice located in a rural area, or a practice in a geographic HPSA:
• Reporting of one medium-weighted activity would result in 10 points which is one-fourth of the highest score.
• Reporting of two medium-weighted activities would result in 20 points which is one-half of the highest score.
• Reporting of three medium-weighted activities would result in 30 points which is three-fourths of the highest score.
• Reporting of four medium-weighted activities would result in 40 points which is the highest score.
• Reporting of one high-weighted activity would result in 20 points which is one-half of the highest score.
• Reporting of two high-weighted activities would result in 40 points which is the highest score.
• Reporting of a combination of medium-weighted and high-weighted activities where the total number of points achieved are calculated based on the number of activities selected and the weighting assigned to that activity (number of medium-weighted activities selected × 10 points + number of high-weighted activities selected × 20 points).
The most any MIPS eligible clinician or group can achieve for the improvement activities performance category is 40 points, so if more activities are selected than, for example, 4 medium-weighted activities, the total points that could be achieved is still 40 points. We refer readers to section II.E.5.g. of this final rule with comment period, regarding activities in the improvement activities performance category that would also qualify for a bonus under the advancing care information performance category. This bonus would be calculated under the Advancing Care Information Performance Category and not under the improvement activities Performance Category.
We also are not finalizing Table 24 of the proposed rule which provided an example of the scoring methodology based on a highest potential score of 60 points for the improvement activities performance category (81 FR 28267). We are instead finalizing Tables 27 and 28 that illustrate the sample scoring methodology for the improvement activities performance category based on a policy of a highest potential score of 40 points, which we are finalizing in this final rule with comment period. The first example in Table 27 illustrates a sample scoring methodology for the improvement activities category for a MIPS eligible clinician that is not an APM participant or certified patient-centered medical home or comparable specialty practice or Medical Home Model and does not qualify as a small practice or a practice located in a rural or HPSA and is not a non-patient facing MIPS eligible clinician.
The next example in Table 28 illustrates two examples of the scoring methodology for MIPS eligible clinicians that are small, rural or geographic HPSA practices or are a non-patient facing MIPS eligible clinician.
We also finalize our proposal to calculate a score of zero points for any MIPS eligible clinician, except for an APM, if they do not report at least one activity. We further finalize that MIPS eligible clinicians or groups participating in APMs are not required to self-identify as part of an APM, but all MIPS eligible clinicians will be required to self-identify as part of a certified patient-centered medical home or comparable specialty practice, a non-patient facing MIPS eligible clinician, a small practice, a practice located in a rural area, or a practice in a geographic HPSA or any combination thereof to self-identify as applicable during attestation following the performance period. We will validate these self-identifications as appropriate.
We refer readers to section II.E.5.g.(6) of this final rule with comment period, for our final methodology for scoring the advancing care information performance category.
Section II.E.6.a. of the proposed rule describes our proposed methodology for assessing and scoring MIPS eligible clinician performance for each of the four performance categories (81 FR 28248-28268). In this section, we proposed the methodology to determine the composite performance score (now called final score) based on the scores for each of the four performance categories. We proposed to define at § 414.1305 the final score as a composite assessment (using a scoring scale of 0 to 100) for each MIPS eligible clinician for a specific performance period determined using the methodology for assessing the total performance of each MIPS eligible clinician according to the performance standards for the applicable measures and activities for each applicable performance category. The final score is the sum of the products of each performance category score and each performance category's assigned weight multiplied by 100.
Section 1848(q)(5)(A) of the Act requires the Secretary to develop a methodology for assessing the total performance of each MIPS eligible clinician according to the performance standards for the applicable measures and activities for each performance category applicable to such clinician for a performance period, and using the methodology, provide for a final score (using a scoring scale of 0 to 100) for
To create a final score from 0-100 based on the individual performance category scores, we proposed to multiply the score for each performance category by the assigned weight for the performance category. We provided in Table 25 of the proposed rule (81 FR 28269), the weights for each performance category for the 2019, 2020 and 2021 MIPS payment years. The resulting weighted performance category scores would be summed to create a single final score. As described in section II.E.2. of the proposed rule (81 FR 28176-28177), we proposed that the identifier for MIPS performance would be the same for all four performance categories, and therefore, the methodology to calculate a final score would be the same for both individual and group performance.
The following equation summarizes the proposed final score calculation at § 414.1380(c): Final score = [(quality performance category score × quality performance category weight) + (cost performance category score × cost performance category weight) + (improvement activities performance category score × improvement activities performance category weight) + (advancing care information performance category score × advancing care information performance category weight)] × 100.
We did not receive comments on our proposal to define at § 414.1305 the final score as a composite assessment (using a scoring scale of 0 to 100) for each MIPS eligible clinician for a specific performance period.
We did receive several comments on our proposal to define at § 414.1380(c) the MIPS final score calculation.
We have aligned the approach to scoring across the performance categories. Measures in the quality, cost, and the advancing care information performance categories are scored based on a point scale between 0 and 10. The measures and activities within each performance category are designed to measure performance on different aspects of high value healthcare within each performance category, therefore the performance requirements and scoring calculations within the performance categories are differentiated as appropriate.
After consideration of the comments, we are codifying our final score definition and final score formula with minor changes for accuracy and to change the labeling of composite performance score to final score. At § 414.1305, final score means a composite assessment (using a scoring scale of 0 to 100) for each MIPS eligible clinician for a performance period determined using the methodology for assessing the total performance of a MIPS eligible clinician according to performance standards for applicable measures and activities for each performance category. The final score is the sum of each of the products of each performance category score and each performance category's assigned weight, multiplied by 100. At § 414.1380(c), we finalize that each MIPS eligible clinician receives a final score of 0 to 100 points equal to the sum of each of the products of each performance category score and each performance category's assigned weight, multiplied by 100.
Section 1848(q)(1)(G) of the Act requires us to consider risk factors in our scoring methodology. Specifically, that section provides that the Secretary, on an ongoing basis, shall, as the Secretary determines appropriate and based on individuals' health status and other risk factors, assess appropriate adjustments to quality measures, cost measures and other measures used under MIPS and assess and implement appropriate adjustments to payment adjustments, final scores, scores for performance categories or scores for measures or activities under the MIPS. In doing this, the Secretary is required to take into account the relevant studies conducted under section 2(d) of the IMPACT Act of 2014 and, as appropriate, other information, including information collected before completion of such studies and recommendations. ASPE is conducting studies on the issue of risk adjustment for socioeconomic status on quality measures and cost measures as required by section 2(d) of the IMPACT Act and expects to issue a report to Congress in October 2016. We will closely examine the ASPE studies when they are available and incorporate findings as feasible and appropriate through future rulemaking. We also note that several MIPS measures, as appropriate, include risk adjustment in their measure specifications. For example, outcome measures in the quality performance category generally have risk adjustment embedded in the measure calculation specification, while process measures generally do not. Similarly, in the cost performance category, the proposed total per capita costs for all attributed beneficiaries measure is adjusted for demographic and clinical factors. That measure also has a specialty adjustment that is applied after the measure calculation to account for differences in specialty mix within a practice. The MSPB measure and other cost measures have different risk adjustments that are specific to the individual measure. For the transition year of MIPS (MIPS payment year 2019), for the quality and cost performance categories, we proposed to use the measure-specific
We invited public comments on this proposal. For discussion of comments specific to risk adjustment for sociodemographic and/or socioeconomic factors we refer readers to section II.E.5.b.(6) of this final rule with comment period.
The following is summary of the comments we received regarding our proposal to use the measure-specific risk adjustment for all measures (where applicable), as well as the additional specialty adjustment for the total per capita costs for all attributed beneficiaries.
After consideration of the comments, we are finalizing our proposal for the quality and cost performance categories to use the measure-specific risk adjustment for all measures (where applicable), as well as the additional specialty adjustment for the total per capita costs measure. Cost measures in the cost performance category are risk adjusted as previously discussed in detail at 77 FR 69317 through 69318 and referenced in section II.E.5.e.(3). Measures finalized for MIPS (see Tables A through D in the Appendix) may be risk adjusted as described in the measure specification using statistical processes to identify and adjust for extraneous variables not associated with care. However, many quality measures are process measures for which the measure outcome is not subject to influence by factors outside the eligible clinicians' control.
Section 1848(q)(5)(E)(i) of the Act specifies weights for the performance categories included in the MIPS final score: in general, 30 percent for the quality performance category, 30 percent for the cost performance category, 25 percent for the advancing care information performance category, and 15 percent for the improvement activities performance category. However, that section also specifies different weightings for the quality and cost performance categories for the first and second years for which the MIPS applies to payments. Section 1848(q)(5)(E)(i)(II)(bb) of the Act specifies that for year 1, not more than 10 percent of the final score will be based on the cost performance category and for year 2, not more than 15 percent will be based on cost performance category. Under section 1848(q)(5)(E)(i)(I)(bb) of the Act, the weight of the quality performance category for each of the first 2 years will increase by the difference of 30 percent minus the weight specified for the cost performance category for the year.
We have proposed the performance category weights for the first MIPS payment year of 2019. In section II.E.5.e.(2) of the proposed rule (81 FR 28198), we proposed to set the cost performance category weight at 10 percent for the 2019 payment year and 15 percent for the 2020 payment year. Correspondingly, in section II.E.5.b.(2), we proposed to set the quality performance category weight to 50 percent for the 2019 payment year and 45 percent for the 2020 payment (81 FR
We received comments on the proposed weights of the MIPS performance categories which are addressed in section II.E.5.b.(2) for quality, section II.E.5.e.(2) for cost, section II.E.5.f.(2) for improvement activities and section II.E.5.g.(2) for advancing care information. As noted in those sections, many commenters expressed concern regarding the proposed weight for the cost performance category. After consideration of the comments and for the reasons stated in those sections, we are adjusting our proposed category weights for the first 2 years of MIPS. We are finalizing that for the first MIPS payment year (2019), the quality performance category will account for 60 percent of the final score and the cost performance category will account for 0 percent of the final score. We are also finalizing that for the second MIPS payment year (2020), the quality performance category will account for 50 percent of the final score and the cost performance category will account for 10 percent of the final score. The final score weights for the improvement activities and advancing care information performance categories are specified in section 1848(q)(5)(E)(i) of the Act, and we did not propose to deviate from those values.
Table 29 summarizes the weights specified for each performance category under section 1848(q)(5)(E)(i) of the Act and in accordance with our final policies which are summarized at § 414.1380(c)(1) and detailed at §§ 414.1330(b), 414.1350(b), 414.1355(b), and 414.1375(a).
Under section 1848(q)(5)(F) of the Act, if there are not sufficient measures and activities applicable and available to each type of MIPS eligible clinician involved, the Secretary shall assign different scoring weights (including a weight of zero) for each performance category based on the extent to which the category is applicable and for each measure and activity based on the extent to which the measure or activity is applicable and available to the type of MIPS eligible clinician involved.
In section II.E.6.a (81 FR 28248-28268) and section II.E.5.g.(8) (81 FR 28230-28234) of the proposed rule, we describe scenarios where certain MIPS eligible clinicians might not receive a performance category score in the quality, cost, or advancing care information performance categories. We proposed that in such scenarios we would use the authority under section 1848(q)(5)(F) of the Act to assign a weight of zero to the performance category and redistribute the weight for that performance category or categories as described in the next section.
Below we summarize these scenarios from the proposed rule. However, our transition year policies and modifications in this final rule to simplify scoring affect many of these scenarios, so we describe both the proposed scenario and how our final policies have impacted that scenario.
For the quality and cost performance categories, in the proposed rule (81 FR 28269-28270), we stated our belief that having sufficient measures applicable and available meant that we are able to reliably calculate a score for the measures that adequately captures and reflects the performance of the MIPS eligible clinician. For the quality and cost performance categories, we proposed in sections II.E.6.a.(2)(d) (81 FR 28254-28255), II.E.6.a.(3)(a) (81 FR 28259-28260), and II.E.6.a.(3)(d) (81 FR 28260-28261) of the proposed rule that we would not calculate a performance category score if a MIPS eligible clinician does not have any measures with the required case minimum or any measures with a sufficient number of MIPS eligible clinicians to create a benchmark. We had proposed that measures that do not meet the required case minimum or a sufficient number of MIPS eligible clinicians to create a benchmark would be excluded from scoring, and the MIPS eligible clinician would not receive a quality or cost performance category score. (Note, this situation is different from a MIPS eligible clinician who elects not to submit any quality measures. A MIPS eligible clinician who elects not to submit any quality measures would receive a quality performance category score of zero.) In our segment II.E.6.a.(2). of the final rule with comment period, we noted that this policy has changed for the quality performance category. We established a policy to assign 3 points for scenarios where a MIPS eligible clinician has quality measures that do not meet case minimum thresholds, do not meet data completeness criteria, or do not have a benchmark. As we noted in those sections we believe that in the initial
In the proposed rule, we anticipated that most MIPS eligible clinicians would select the measures for the quality performance category that are most relevant to their practice and that in most cases, the measures they select would meet the required case minimum. We planned to monitor measure selection trends under the performance category and would revise this policy if it appears MIPS eligible clinicians are reporting measures that are not relevant to their practice or measures that do not meet the required case minimum. With the new 3-point policy, we do not believe MIPS eligible clinicians would purposefully select measures with low case volume in order to avoid a score. Rather, we believe that the overwhelming majority of MIPS eligible clinicians aim to meet our performance criteria in the most straightforward manner possible. As described in II.E.5.b.(3)(a)(i) and II.E.6.a.(2)(d) of this final rule with comment period, we will continue to monitor the selection of measures and may adjust policies if we determine MIPS eligible clinicians are not reporting measures for which they can be scored.
In the cost performance category, we believe MIPS eligible clinicians who are not attributed enough cases to be reliably measured should not be scored for the performance category. We have finalized in section II.E.5.e. of this final rule with comment period, the measures for the cost performance category; however, if a MIPS eligible clinician is not attributed a sufficient number of cases for a measure (in other words, has not met the required case minimum for the measure) or if a measure does not have a benchmark, then the measure will not be scored for that clinician in accordance with the final policy in section II.E.6.(a)(3) of this final rule with comment period. However, while we are scoring cost measures in the transition year of MIPS (MIPS payment year 2019), they are not contributing to transition year final scores as we have set the cost performance category weight to 0 percent in the transition year.
We refer readers to section II.E.5.g.(8) of this final rule with comment period for a detailed discussion of the scenarios in which a MIPS eligible clinician may not have sufficient measures applicable and available under the advancing care information performance category. For the improvement activities performance category, however, we envision that all MIPS eligible clinicians would have sufficient activities applicable and available and did not propose any scenario where a MIPS eligible clinician would not receive an improvement activities performance category score.
In addition to scenarios where a MIPS eligible clinician would have no scored measures for a performance category, we stated in the proposed rule that we believe there may be scenarios in which a MIPS eligible clinician would have too few scored measures under the quality performance category for us to reliably calculate a performance category score that is worth half the weight of the final score for the 2019 MIPS payment year. We proposed that if a MIPS eligible clinician has fewer than three scored quality measures (either submitted measures or measures calculated from administrative claims data) for a performance period, we would consider the MIPS eligible clinician not to have a sufficient number of measures applicable and available for the 2019 MIPS payment year quality performance category weight and would therefore lower the weight of the quality performance category. In this situation, we stated in the proposed rule that the MIPS eligible clinician has a quality performance category score, but has data for only one or two scored measures, which is not a sufficient number of measures for the quality performance category because the quality performance category would constitute half of the final score for the 2019 MIPS payment year. In addition, as described in the next section, for MIPS eligible clinicians that are not scored on the cost or advancing care information performance category, we proposed to increase the weight of the quality performance category. For these reasons, we proposed that for the transition year of MIPS (MIPS payment year 2019), the quality performance category requires a sufficient number of measures to justify its weight in the final score. We noted we would reconsider this policy in future years as the weights for the performance categories change. We proposed that we would consider implementing a similar policy for the cost performance category for future years, but not for the transition year of MIPS based upon the lower weighting of the cost performance category.
In the proposed rule (81 FR 28186), we proposed for the quality performance category, generally, that MIPS eligible clinicians submit a minimum of six measures for scoring in MIPS. In addition, we proposed to include up to three population-based measures derived from claims data. As described in section II.E.6.a.(2) of the proposed rule (81 FR 28250-28259), a MIPS eligible clinician may submit a measure that is not scored, either because the measure did not meet the required case minimum to be reliably measured or because fewer than 20 MIPS eligible clinicians with sufficient volume submitted a measure through a similar reporting mechanism and a benchmark could not be created for the performance or baseline period. We reiterated that a measure that is not scored due to not meeting the required case minimum or lack of a measure benchmark, is different than a required measure that is not reported. Any required measure that is not reported or reported with in a way that does not meet the data completeness requirements would receive a score of zero points and would be considered a scored measure. In section II.E.5.b.(6), we have modified our final policies to reflect that only one of the three population-based measures is being finalized. Additionally, in section II.E.6.a.(2)(d), we have modified our approach for quality measures that fall below case minimum requirements, data completeness thresholds and measures without a benchmark to include a 3-point measure floor.
We stated in the proposed rule that we are concerned that if a large percentage of the expected measures are not able to be scored due to not meeting the required case minimums or a missing benchmark, then just one or two measures would contribute disproportionately to the final score because the quality performance category score is worth 30 to 50 percent (depending on the year) of the final score under section 1848(q)(5)(E)(i) of the Act. We did not believe a score for one or two quality measures can capture all the elements of quality performance during a performance period. We believed the lack of a sufficient number of measures for scoring limits the value of quality performance measurement toward the final score. Therefore, we
We requested comment on these proposals to identify MIPS eligible clinicians without sufficient measures and activities applicable and available and our proposals to reweight those performance categories. We also sought comment on alternative methods for reweighting performance categories for MIPS eligible clinicians without sufficient measures and activities in certain performance categories. We seek to ensure that reweighting would not cause an eligible clinician to be either advantaged or disadvantaged due to a lack of sufficient measures and activities applicable and available, and a corresponding inability to generate a score for a certain performance category.
The following is summary of the comments we received regarding our proposal to consider MIPS eligible clinicians with fewer than three scored quality measures as having insufficient measures applicable and available for the 2019 MIPS payment year quality performance category and to, therefore, lower the weight of the quality performance category.
We will not finalize our proposed policy to reduce and redistribute the weight of the quality performance category if only one or two measures are scored. We will finalize with modification our proposed policy to reduce and redistribute the quality performance category weight if a MIPS eligible clinician has no scored measures for the quality performance category for the transition year (MIPS payment year 2019), although we believe this scenario will be unlikely. We have modified our approach because, under our policies for the quality performance category for the transition year, we believe it is less likely that a MIPS eligible clinician will have only 1 or 2 scored measures. As discussed in section II.E.6.a.(2), all quality performance category measures that are submitted receive at least 3 points. In addition, any required measure that is not submitted receives a score of 0 points. Therefore, a MIPS eligible clinician submitting data as an individual, who has at least 6 measures applicable and available, who submits one measure is still scored on six measures. One measure receives a score of at least 3 points and the other five measures receive zero points. With this adjustment in the quality scoring, we believe the number of instances where a MIPS eligible clinician has fewer than 3 scored measures will be reduced. Eliminating the proposed reduction and redistribution of the weight of the quality performance category if only one or two measures are scored further simplifies scoring for the transition year. We refer readers to section II.E.6.b.(2)(c) of this final rule with comment period for discussion of how the quality performance category weight will be redistributed in instances where a MIPS eligible clinician is not scored on any quality measures and receives a null score in the quality performance category.
In Table 17 in section II.E.6.a.(2)(c), we summarize two classes of quality measures for the quality performance category: “Class 1” are those measures for which performance can be reliably scored against a benchmark and “class 2” are measures for which performance cannot be reliably scored against a benchmark. For the transition year (MIPS payment year 2019), we have modified our proposed approach on how we will score measures submitted that are unreliable because they are below the case minimum requirements, or lack a benchmark or do not meet data completeness criteria. These measures will not be scored based on performance against a benchmark, but will receive an automatic three points. We believe this policy will simplify quality performance category scoring. We want to ensure that every clinician that submits quality data will receive a quality performance category score, even if the quality data submitted is class 2 measures. This is particularly important in the transition year because with a minimum 90-day performance period, we anticipate more MIPS eligible clinicians will submit measures below the case minimum requirements. We selected three points because we did not want to provide more credit for reporting a measure than cannot be reliably scored against a benchmark than for measures for which we can measure performance against a benchmark. Again, any measure that was not submitted would also receive a zero score.
As noted in this final rule with comment period, we have decided not to finalize our proposed approach to reduce the weight of the quality performance category in the final score if only one or two measures are scored for the following reasons. First, we want to create an opportunity for all MIPS eligible clinicians to participate and succeed in MIPS through minimal quality performance category measure submission during the transition year. Second, we want to create a thoughtful “ramp” into the program for participants that is sensitive to stakeholder concerns. Many commenters in section II.E.6.a.(2)(c) requested that we provide “credit” for measures that were submitted that did not meet the quality submission criteria.
In response to the request for clarification on how we would identify clinicians without sufficient measures and activities, we refer readers to section II.E.5.b.(3)(a)(i) and II.E.6.a.(2)(d) of this rule for a discussion of our validation process to assess whether measures for the quality performance category are applicable and available, section II.E.5.g.(8) of this rule for a discussion of when measures for the advancing care information performance category may not be applicable and available, and section II.E.6.a.(3) of this rule for a discussion of when measures for the cost performance category may not be are applicable and available. As we stated in the proposed rule, we believe the activities specified for the improvement activities performance category will always be applicable and available to all MIPS eligible clinicians.
After consideration of the comments, and for the reasons explained in our responses above, we are not finalizing our proposal to reduce and redistribute the weight of the quality performance category when a MIPS eligible clinician has only one or two scored quality measures. Maintaining a consistent quality performance category weight whenever at least one measure can be scored will increase simplicity and predictability of scoring for MIPS eligible clinicians. We may revisit this policy at a future date through rulemaking. See section II.E.6.b.(2)(c) of this final rule with comment period for discussion of how we will reduce and redistribute the weight of the quality performance category to other performance categories when a MIPS eligible clinician has no scored measures in the quality performance category.
We proposed at § 414.1380(c)(2) to redistribute the weights of the performance categories for MIPS eligible clinicians when there are not sufficient measures and activities applicable and available to them. We proposed to redistribute the weights of the performance categories in the following situations.
If the MIPS eligible clinician does not receive a cost or advancing care information performance category score, and has at least three scored measures (either submitted measures or those calculated from administrative claims) in the quality performance category, then we proposed to reassign the weights of the performance categories without a score to the quality performance category. We believed this policy was appropriate for several reasons. First, section 1848(q)(5)(E)(i)(I)(bb) of the Act redistributes weight from the cost performance category to the quality performance category in the first 2 years of MIPS. This proposal is consistent with that redistribution logic. In addition, MIPS eligible clinicians have experience reporting quality measures through the PQRS program, and measurement in this performance category is more mature. Finally, for the 2019 MIPS payment year, quality performance would be worth at least half of the final score. By requiring the MIPS eligible clinician to have at least three scored quality measures, we believe the quality performance category would be robust enough to support more weight reassigned to it than other performance categories. We stated that we may revisit this policy in future years as the weight for the cost performance category increases and the weight for the quality performance category decreases.
We also proposed an alternative that does not reassign all the weight to the quality performance category, but rather
We requested public comments on the proposal to reassign the weights to the quality performance category, as well as the alternate proposal to redistribute proportionately to other performance categories.
If the MIPS eligible clinician has fewer than three scored measures in the quality performance category score, then we proposed to reassign the weights for the performance categories without scores proportionately to the other performance categories for which the MIPS eligible clinician has received a performance category score. We requested comment on this proposal.
Finally, because the final score is a composite score, we stated in the proposed rule that we believe the intention of section 1848(q)(5) of the Act is for MIPS eligible clinicians to be scored based on multiple performance categories. Basing a final score on a single performance category, even a robust and familiar performance category like quality, would frustrate that intent. In our proposals, improvement activities is the only performance category which would always have a performance category score. We were particularly concerned about the possibility that a MIPS eligible clinician might, for the reasons discussed above, not have sufficient measures applicable and available for the quality, cost, and advancing care information performance categories, and would only receive a score for the improvement activities performance category. The improvement activities performance category is based on activities that are reported by attestation, not on measured performance. In addition, because the improvement activities performance category is not as mature as the other performance categories, each of which include certain aspects of existing CMS programs, we were unsure how much variation we will have in the improvement activities performance category. We did not believe it would be equitable to allow MIPS eligible clinicians that attest to receive the maximum points for that performance category and then base the final score solely on the improvement activities performance category. Such a scenario may result in higher final score and MIPS adjustment factors for some MIPS eligible clinicians based solely on the improvement activities performance category, while other MIPS eligible clinicians are measured based on their performance under the other performance categories. Therefore, we proposed that if a MIPS eligible clinician receives a score for only one performance category, we would assign the MIPS eligible clinician a final score that is equal to the performance threshold described in section II.E.7.c of the proposed rule (81 FR 28273), which means the eligible clinician would receive a MIPS payment adjustment factor of 0 percent for the year. We anticipated this proposal would affect very few MIPS eligible clinicians in year 1 and even fewer in future years as more eligible clinicians are able to report on and receive scores for more of the performance categories.
We requested public comment on this proposal.
The following is summary of the comments we received regarding our proposal to reassign performance category weights to the quality performance category when an eligible clinician cannot be scored in a category and has at least three scored measures in the quality performance category.
The cost performance category is weighted at zero percent in the final score under our transition year policies. As discussed earlier in this section, we believe it would not be appropriate to allocate substantial additional weight to improvement activities in the transition year of MIPS before we have gained additional experience with the improvement activities performance category. Therefore, while we understand the commenters concerns about placing additional weight in the quality category, section 1848(q)(5)(E)(i) of the Act seems to favor an approach where quality is given substantial weight in the final score during the first 2 years of MIPS. We may revisit this policy in future years.
After consideration of the comments, we are codifying at § 414.1380(c)(2) that we will assign different weights than the ones listed in § 414.1380(c)(1) when we determine that there are not sufficient measures and activities applicable and available to MIPS eligible clinicians.
For the transition year (MIPS payment year 2019), we are codifying with modification our proposal to redistribute the weight of the cost and advancing care information performance categories to the quality performance category when there are not sufficient measures applicable and available to a MIPS eligible clinician under the cost and advancing care information performance categories and thus the clinician does not receive a score for those performance categories. We are not finalizing the requirement that the quality performance category have a minimum of three scored measures in order to redistribute the weight of the cost and advancing care information performance categories to the quality performance category. Maintaining a consistent quality performance category weight whenever at least one measure can be scored will increase simplicity and predictability of scoring for MIPS eligible clinicians while learning the program.
The following is a summary of the comments regarding our proposal to reduce the weight of the quality performance category and redistribute the amount by which it is reduced to the other performance categories, in the event a MIPS eligible clinician has fewer than three scored measures in the quality performance category.
After consideration of the comments, and for the reasons discussed in our responses above, we are finalizing a modification of our proposal to reduce the weight of the quality performance category and redistribute the amount by which it is reduced to the other performance categories if the eligible clinician has fewer than three scored quality measures. MIPS eligible clinicians will receive a quality performance category score as long as they are scored on at least one quality measure. We believe it is unlikely that a MIPS eligible clinician will not receive a score for at least one quality measure as a result of our final policy for the transition year to provide a 3-point floor for all reported quality measure in the quality performance category (see II.E.6.a.(2) of this final rule with comment period). In the event a MIPS eligible clinician is not scored on at least one measure in the quality performance category because there are not sufficient measures applicable and available, for the transition year (MIPS payment year 2019), we will redistribute the 60 percent weight of the quality performance category so that the performance category weights are 50 percent for advancing care information and 50 percent for improvement activities. We are finalizing this policy for the MIPS payment year 2019 and will revisit this approach for later years through future rulemaking. With the 3-point floor policy, we anticipate almost all MIPS eligible clinicians will have a quality performance category score. We believe that only in rare circumstances would a MIPS eligible clinician have no applicable and available quality measures. This approach is similar to our proposal but takes into account our final policy to weight the cost performance category at 0 percent in the transition year of MIPS and responds to commenter requests for additional simplicity in our policies for reweighting the performance categories. Table 30 summarizes these final policies.
The following is summary of the comments we received regarding our proposal to assign MIPS eligible clinicians with only one scored performance category a final score that is equal to the performance threshold.
After consideration of the comments, we are finalizing our proposal to assign MIPS eligible clinicians with only one scored performance category a final score that is equal to the performance threshold. We note that with the scoring changes to the quality performance category, we do anticipate that almost all MIPS eligible clinicians will have
Based upon the policies we are finalizing; we summarize in Table 30 the potential reweighting scenarios for the transition year of MIPS (MIPS payment year 2019):
We do not include a scenario where a MIPS eligible clinician does not receive an improvement activities performance category score. MIPS eligible clinicians that do not submit any improvement activities data receive a zero percent score for that performance category.
As we described in section II.E.2. of the proposed rule (81 FR 28271), we proposed to allow MIPS eligible clinicians to measure performance as an individual, as a group defined by TIN, or as an APM Entity group using the APM scoring standard. However, for purposes of the application of the MIPS payment adjustment factors to payments in accordance with section 1848(q)(6)(E) of the Act (referred to as the MIPS payment adjustment), we proposed to use a single identifier, TIN/NPI, for all MIPS eligible clinicians, regardless of whether the TIN/NPI was measured as an individual, group or APM Entity group. In other words, a TIN/NPI may receive a final score based on individual, group, or APM Entity group performance, but the MIPS payment adjustment would be applied at the TIN/NPI level.
We proposed to use the single identifier, TIN/NPI, for the MIPS payment adjustment for several reasons. First, the final eligibility status of some clinicians would not be known until after the performance period ends. For example, the calculations determining which clinicians would be excluded from MIPS, such as identifying clinicians that are QPs or are below the low-volume threshold, occur after the performance period ends. Using TIN/NPI would allow us to correctly identify which TIN/NPIs are still MIPS eligible clinicians after the exclusion criteria have been applied.
Second, the identifiers for quality measurement are not mutually exclusive, and using TIN/NPI to apply the MIPS payment adjustment would allow us to resolve any inconsistencies that arise from the measurement identifiers. For example, a TIN may have 40 percent of its eligible clinicians participating in a MIPS APM and the remaining 60 percent are not participating in any APM. The TIN elects to submit performance information for all the eligible clinicians in the TIN, including those that are participating in the MIPS APM, so that it can ensure all of its eligible clinicians are being measured in MIPS. We cannot simply use the APM Entity and TIN identifiers because in this case, we either have eligible clinicians with duplicative data and overlapping scores, or we have portions of the measurement identifier carved out if we eliminate the overlap. In our example, the eligible clinicians participating in the MIPS APM would have data for two final scores (one based on the APM Entity group performance and one based on the group TIN performance). The eligible clinicians not participating in the MIPS APM would have only one final score (one based on the group TIN performance). Applying the MIPS payment adjustment at the TIN/NPI level provides us the flexibility to correctly identify and resolve the conflicts emerging when measurement identifiers overlap. The TIN/NPI identifier is mutually exclusive on all of our measurement identifier options; therefore, we believe this identifier can be consistently used for individual, group, or APM scoring standard identifiers. We refer readers to 81 FR 28271 for a discussion of identifiers and our proposals related to them.
The following is summary of the comments we received regarding our proposal to use the TIN/NPI combination as the MIPS payment adjustment identifier.
Eligible clinicians will be scored across the four performance categories either as an individual or through their group. It is our intent that an eligible clinician reporting through a group will be scored as part of that group for all performance categories, or conversely, that an eligible clinician reporting as an individual will be scored on their individual data for all performance categories.
We would also like to note that all TIN/NPIs participating in a group practice or APM Entity will have the same final score and the same MIPS payment adjustment. The only time the TIN/NPIs will vary across a group practice will be when a TIN/NPI: (1) Is excluded from MIPS; (2) has multiple possible final score submissions (for example an APM Entity final score and a TIN final score); or (3) the TIN/NPI is new to a TIN or a TIN is new and therefore does not have historical data associated with the TIN/NPI.
After consideration of these comments, we are finalizing our proposal to adopt the TIN/NPI combination as the MIPS payment adjustment identifier.
Because we proposed to use only TIN/NPI to apply the MIPS payment adjustments and because there is a gap between the performance period and the MIPS payment year, we believe we should assign the historical final score to each TIN/NPI that is subject to MIPS for the payment year.
In general, we proposed to use the final score associated with the TIN/NPI combination in the performance period. For groups submitting data using the TIN identifier, we proposed to apply the group final score to all the TIN/NPI combinations that bill under that TIN during the performance period. For individual MIPS eligible clinicians submitting data using TIN/NPI, we proposed to use the final score associated with the TIN/NPI that is used during the performance period. For eligible clinicians in MIPS APMs, we proposed to assign the APM Entity group's final score to all the APM Entity Participant Identifiers that are associated with the APM Entity. We refer readers to section II.E.5.h. of this final rule with comment period for more information about the process to identify participating APM Entities. For eligible clinicians that participate in APMs for which the APM scoring standard does not apply, we proposed to assign a final score using either the individual or group data submission assignments described above.
In the case where a MIPS eligible clinician starts working in a new practice or otherwise establishes a new TIN that did not exist during the performance period, there would be no corresponding historical performance information or final score for the new TIN/NPI. Because we want to connect actual performance to the individual MIPS eligible clinician as often as possible, in cases where there is no final score associated with a TIN/NPI from the performance period, we proposed to use the NPI's performance for the TIN(s) the NPI was billing under during the performance period. If the MIPS eligible clinician has only one final score associated with the NPI from the performance period, then we proposed to use that final score. For example, if a MIPS eligible clinician worked in one practice (TIN A) in the performance period, but is working at a new practice (TIN B) during the payment year, then we would use the final score for the old practice (TIN A/NPI) to apply the MIPS payment adjustment for the NPI in the new practice (TIN B/NPI). This proposal most closely linked the MIPS eligible clinician's performance during the performance period to the MIPS payment adjustment. It also ensured that MIPS eligible clinicians that qualify for a positive MIPS payment adjustment are able to keep it, even if they change practices. For those who have a negative MIPS payment adjustment, this proposal also ensured MIPS eligible clinicians are still accountable for their performance.
In scenarios where the MIPS eligible clinician billed under more than one TIN during the performance period, and the MIPS eligible clinician starts working in a new practice or otherwise establishes a new TIN that did not exist during the performance period, we proposed to use a weighted average final score based on total allowed charges associated with the NPI from the performance period. This proposal would provide a final score that is based on all the services the NPI billed to Medicare during the performance period. Table 26 of the proposed rule (81 FR 28272), presents an example of how the weighted average proposed approach would work. If an NPI did not have any allowed charges in the performance period, then the clinician
We also proposed an alternative policy where in lieu of taking the weighted average, we take the highest final score from the performance period. We believe the alternative approach rewards MIPS eligible clinicians for their prior performance and may be easier to implement in the transition year of MIPS. Our concern with this approach is that the highest final score may represent a relatively small portion of the MIPS eligible clinician's practice during the performance period.
We requested comment on the proposal to use the final score associated with the TIN(s) the NPI was billing under during the performance period when the TIN/NPI does not have a final score from the performance period. We also requested comment on our proposal to use a weighted average, and the alternative proposal to select the highest final score from the performance period.
We also considered, but did not propose, a policy to have the performance follow the group (TIN) rather than the individual (NPI). In other words, the MIPS eligible clinician's performance would be based on the historical performance of the new TIN that the MIPS eligible clinician moved to after the performance period, even though the MIPS eligible clinician was not part of this group during the performance period. This policy is consistent with the VM and would create incentives for MIPS eligible clinicians to move to higher performing practices (77 FR 69308). We also believe this policy would provide a lower burden for practice administrators as all MIPS eligible clinicians in the TIN would have the same MIPS payment adjustment. On the other hand, having performance follow the TIN creates some challenges. We are concerned that MIPS eligible clinicians who earned a positive MIPS payment adjustment based on their performance during the performance period would not retain the positive MIPS payment adjustment if the new TIN had a lower final score. Finally, we believe that having performance follow the TIN could create some unanticipated issues with budget neutrality if high-performing TINs expand. For all of these reasons, we did not propose to have performance follow the TIN, but rather have performance follow the NPI; however, we solicited comment on this option.
In some cases, a TIN/NPI could have more than one final score associated with it from the performance period, if the MIPS eligible clinician submitted duplicative data sets. In this situation, the MIPS eligible clinician has not changed practices, rather for example, a MIPS eligible clinician has a final score for an APM Entity and a final score for a group TIN. If a MIPS eligible clinician has multiple final scores, we proposed a multi-pronged approach to select the final score that would be used to determine the MIPS payment adjustment. First, we proposed that if a MIPS eligible clinician is a participant in MIPS APM, then the APM Entity final score would be used instead of any other final score (such as a group TIN final score or individual final score). We proposed that if a MIPS eligible clinician has more than one APM Entity final score for the same TIN (by participating in multiple MIPS APMs), we would apply the highest APM Entity final score to the MIPS eligible clinician. Second, if a MIPS eligible clinician reports as a group and as an individual, we would calculate a final score for the group and individual identifier and use the highest final score for the TIN/NPI. We requested comment on this proposed approach.
The following is summary of the comments we received regarding our proposals for the final score used in the MIPS payment adjustment calculation.
We do not believe it would be appropriate to assign a neutral score when performance data for the NPI is available.
In response to concerns that an undue burden would be placed on the hiring entity, we are not asking TINs to perform any of the calculations. We will apply the specific MIPS payment adjustment that needs to be applied for that specific TIN/NPI for the payment year. We seek feedback on ways to provide the necessary information to practices to minimize burden for them.
In response to concerns about the adverse effect on a new TIN that hires an individual that had a lower final score in the performance period, we want to reiterate that the MIPS payment adjustment is only being applied to that individual TIN/NPI and not all NPIs in that same hiring TIN and that in some cases the MIPS payment adjustment is positive. We believe that our policy tracks accountability to the clinician and will actually encourage all clinicians to seek high performance.
After consideration of these comments, we are finalizing our policy to use the TIN/NPI's historical performance from the performance period associated with the MIPS payment adjustment, regardless of whether that NPI is billing under a new TIN after the performance period. In the event that an NPI bills under multiple TINs in the performance period and bills under a new TIN in the MIPS payment year, we are finalizing our alternative policy of taking the highest final score associated with that NPI in the performance period.
Section 1848(q)(6)(A) of the Act requires the Secretary to specify a MIPS adjustment factor (referred to as a MIPS payment adjustment factor) for each MIPS eligible clinician for a year determined by comparing the final score of the MIPS eligible clinician for such year to the performance threshold established under paragraph (D)(i) for such year, in a manner such that the adjustment factors specified for a year result in differential payments. Section 1848(q)(6)(A)(iii) of the Act provides that MIPS eligible clinicians with a final score at or above the performance threshold receive a zero or positive MIPS adjustment factor on a linear sliding scale such that a MIPS adjustment factor of 0 percent is assigned for a final score at the performance threshold and a MIPS adjustment factor of the applicable percent is assigned for a final score of 100. Positive MIPS adjustment factors may be increased or decreased by a scaling factor (not to exceed 3.0) to ensure the budget neutrality requirement is met.
Section 1848(q)(6)(A)(iv) of the Act provides that MIPS eligible clinicians with a final score below the performance threshold receive a negative MIPS adjustment factor on a linear sliding scale such that a MIPS adjustment factor of 0 percent is assigned for a final score at the performance threshold and a MIPS adjustment factor of the negative of the applicable percent is assigned for a final score of 0; further, MIPS eligible clinicians with final scores that are equal to or greater than zero, but not greater than one-fourth of the performance threshold, receive a negative MIPS adjustment factor that is equal to the negative of the applicable percent. Section 1848(q)(6)(B) of the Act defines the applicable percent for each year as follows: (i) For 2019, 4 percent; (ii) for 2020, 5 percent; (iii) for 2021, 7 percent; and (iv) for 2022 and subsequent years, 9 percent.
Section 1848(q)(6)(C) of the Act provides for an additional positive MIPS payment adjustment factor for exceptional performance (referred to as an additional MIPS payment adjustment factor), for each of the years 2019 through 2024, for each MIPS eligible clinician with a final score for a year at or above the additional performance threshold under paragraph (D)(ii) for such year. The additional MIPS payment adjustment factor shall be in the form of a percent and determined in a manner such that MIPS eligible clinicians having higher final scores above the additional performance threshold receive higher additional MIPS payment adjustment factors.
We are codifying these requirements as follows:
At § 414.1405(a), we are codifying that each MIPS eligible clinician receives a MIPS payment adjustment factor, and if applicable an additional MIPS payment adjustment factor for exceptional performance, for a MIPS payment year determined by comparing their final score to the performance threshold and additional performance threshold for the year.
At § 414.1405(b)(1), we are codifying that MIPS eligible clinicians with a final score at or above the performance threshold receive a zero or positive
At § 414.1405(b)(2), we are codifying that MIPS eligible clinicians with a final score below the performance threshold receive a negative MIPS payment adjustment factor on a linear sliding scale such that an adjustment factor of 0 percent is assigned for a final score at the performance threshold and an adjustment factor of the negative of the applicable percent is assigned for a final score of 0; further, MIPS eligible clinicians with final scores that are equal to or greater than zero, but not greater than one-fourth of the performance threshold, receive a negative MIPS payment adjustment factor that is equal to the negative of the applicable percent.
At § 414.1405(c), we are codifying the applicable percent.
Under section 1848(q)(6)(D)(i) of the Act, for each year of the MIPS, the Secretary shall compute a performance threshold for which the final scores of MIPS eligible clinicians are compared for purposes of determining the MIPS payment adjustment factors under section 1848(q)(6)(A) of the Act for a year. The performance threshold for a year must be either the mean or median (as selected by the Secretary, and which may be reassessed every 3 years) of the final scores for all MIPS eligible clinicians for a prior period specified by the Secretary. Section 1848(q)(6)(D)(iii) of the Act outlines a special rule for the initial 2 years of MIPS, which requires the Secretary, prior to the performance period for such years, to establish a performance threshold for purposes of determining the MIPS payment adjustment factors under section 1848(q)(6)(A) of the Act and an additional performance threshold for purposes of determining the additional MIPS payment adjustment factors under section 1848(q)(6)(C) of the Act, each of which shall be based on a period prior to the performance periods and take into account data available for performance on measures and activities that may be used under the performance categories and other factors determined appropriate by the Secretary.
We are codifying the definition of the term “performance threshold” at § 414.1305 as the numerical threshold for a MIPS payment year against which the final scores of MIPS eligible clinicians are compared to determine the MIPS payment adjustment factors. Final scores above the performance threshold receive a positive MIPS payment adjustment factor and final scores below the performance threshold receive a negative MIPS payment adjustment factor. Final scores that are equal to or greater than 0, but not greater than one-fourth of the performance threshold receive the maximum negative MIPS payment adjustment factor for the MIPS payment year. Final scores at the performance threshold receive a neutral MIPS payment adjustment factor.
To establish the performance threshold for the 2019 MIPS payment year, we proposed to model 2014 and 2015 Medicare Part B allowed charges, 2014 and 2015 PQRS data submissions, 2014 and 2015 QRUR and sQRUR feedback data, and 2014 and 2015 Medicare and Medicaid EHR Incentive Program data to inform where the performance threshold should be. We would use this data to estimate the impact of the quality and cost scoring proposals. We would also use the EHR Incentive Program information to estimate which MIPS eligible clinicians are likely to receive points for the advancing care information performance category. Because of the lack of historical data for the improvement activities performance category, we would apply some sensitivity analyses to help inform where the performance threshold should be.
For the 2019 MIPS payment year, we proposed to set the performance threshold at a level where approximately half of the eligible clinicians would be below the performance threshold and half would be above the performance threshold, which we believe is consistent with the intent of section 1848(q)(6)(D)(i) of the Act which requires the performance threshold in year 3 and beyond to be equal to the mean or median of final scores from a prior period. We also considered other policy options when setting the performance threshold. For example, we considered setting the performance threshold so that the scaling factor (which is described in section II.E.7.b. of the proposed rule (81 FR 28273) is 1.0. We could set the performance threshold based on policy goals to ensure a minimum number of points are earned before an eligible clinician is able to receive a positive MIPS adjustment factor and potentially an additional adjustment factor for exceptional performance. We solicited comment on the policy options for setting the performance threshold.
The following is summary of the comments we received regarding our proposals for setting the performance threshold for the 2019 MIPS payment year.
One commenter referred to the estimate that half of eligible clinicians would fall below the performance threshold and recommended that CMS create a structure whereby fewer clinicians are penalized during the
Section 1848(q)(6)(D)(iii) of the Act includes a special rule to establish the performance threshold and the additional performance threshold for the first 2 years of MIPS. Specifically, the Secretary shall, prior to the performance period for such years, establish a performance threshold for purposes of determining the MIPS payment adjustment factors under section 1848(q)(6) (A) of the Act and an additional performance threshold for purposes of determining the additional MIPS payment adjustment factors under section 1848(q)(6)(C) of the Act, each of which shall be based on a period prior to the performance periods and take into account data available for performance on measures and activities that may be used under the performance categories and other factors determined appropriate by the Secretary.
We are relying on the special rule under section 1848(q)(6)(D)(iii) of the Act to establish the performance threshold and the additional performance threshold for the 2019 MIPS payment year to create a transition year policy that encourages participation and provides an opportunity for MIPS eligible clinicians to become familiar with MIPS and other aspects of the Quality Payment Program.
We considered available data regarding performance on measures and activities that may be used under the MIPS performance categories. With regard to the quality performance category, we took several steps to identify PQRS participation rates for MIPS eligible clinicians. First, we identified the TIN/NPIs who billed a Medicare Part B service in 2015. We used clinician type and specialty information from NPPES to establish a subset of those clinician types who are eligible for MIPS as described in section II.E.1 of this rule. We then used 2015 Part B data to exclude those who did not exceed the low-volume threshold as defined in section II.E.3 of this rule. We used 2015 PQRS data to assess whether to apply the low-volume at the individual (TIN/NPI) or group (TIN) level. We assumed all Shared Savings Program participants would exceed the low volume threshold because the Shared Savings Program has a requirement that the ACOs be attributed a minimum number of patients.
Due to data limitations, we had to proxy new enrollment by identifying NPIs who billed PFS services in 2015 and not in 2014. We also excluded 2015 Pioneer ACO participants and CPC participants as we estimated they might represent QPs in the future. We were not able to specifically identify the exact number of QPs or Partial QPs. We refer readers to the regulatory impact analysis in section V.C. of this final rule with comment period for more details on this analysis. We estimate between 592,119-642,119 MIPS eligible clinicians, but due to the model limitations to identify QP and Partial QPs, we included 676,722 MIPS eligible clinicians in our model.
We used the 2015 PQRS data to create benchmarks for our model based on our final policies and assign points under the quality performance category based on performance. For the readmission measure we used the 2014 VM analytic file, which was the most recent data available. We then estimated final scores using the quality performance category scores. We did not include cost measures because the cost performance category has 0 percent weight in the 2019 final score. We did not include data for improvement activities or advancing care information because we did not have detailed performance data available for all MIPS eligible clinicians. While we have some performance data for the Medicare EHR Incentive Program, we do not have detailed performance data for the Medicaid EHR Incentive Program. Having performance data for only a portion of MIPS eligible clinicians would have skewed the analysis; therefore, we restricted our analysis to the quality performance data only.
Using 2015 PQRS data, we determined which of these MIPS eligible clinicians participated and calculated participation rates for the MIPS quality performance category, the performance category that accounts for a minimum of 60 percent of the transition year final score. For our participation counts, we did not include other data files because 2015 information was either not available or would not have impacted the participation score. We noted that 87.2 percent of the estimated MIPS eligible clinicians submitted data to PQRS, but the participation rate is lower for solo practitioners and practices with 2-9 clinicians at 58.2 percent. As mentioned in this final rule with comment period, we want to create a scenario where many MIPS eligible clinicians have the ability to participate while transitioning to the MIPS.
We are setting the performance threshold at 3 points for the 2019 MIPS payment year taking into account the data available as described above, but also based on other factors we believe are appropriate, such as encouraging participation in the first year of MIPS. We want to ensure that MIPS eligible clinicians are allowed time to gain understanding of the MIPS and pick their pace as they report on the MIPS performance categories. We believe that setting the performance threshold at 3 points will encourage more MIPS
As commenters note above, the lower performance threshold will “flatten the curve” in that relatively fewer MIPS eligible clinicians would receive a negative MIPS payment adjustment which would lower the scaling factor required by budget neutrality. In other words, the amount of the positive MIPS payment adjustment from the adjustment factor on a per-clinician basis will be less than under our initial proposal as more MIPS eligible clinicians would qualify for a positive MIPS payment adjustment; however, we believe this is necessary in order to achieve our transition year goals.
While we have lowered the performance threshold as part of our transition year policies, we do not think it would be appropriate to lower the additional performance threshold, as the additional performance threshold is the point at which MIPS eligible clinicians can receive an additional adjustment factor for exceptional performance. As we discuss in the next section, we will decouple the performance threshold and the additional performance threshold and set the additional performance threshold at 70 points. The lower performance threshold of 3 points will meet our policy goal to increase participation in the first year of MIPS and transparency in the scoring methodology; however, we believe that MIPS eligible clinicians must demonstrate exceptional performance to receive an additional adjustment factor.
We intend to increase the performance threshold in year 2 and beginning in year 3 we will use the mean or median final score from a prior period as required by section 1848(q)(6)(D)(i) of the Act. The performance threshold and other transition year policies provide an opportunity for MIPS eligible clinicians to pick their pace in participation. This encourages MIPS eligible clinicians to participate and become familiar with the MIPS requirements.
Also, while we are finalizing a performance threshold of 3 and an additional performance threshold of 70 in this rule, in future years we may not publish the numerical performance threshold and additional performance threshold in a final rule. We would finalize our methodology for calculating these thresholds via notice and comment rulemaking and then utilize that methodology to calculate and announce the performance threshold and additional performance threshold for a MIPS payment year on a Web site prior to the performance period, rather than publishing the numerical thresholds within a final rule.
Beginning with the third MIPS payment year (2021), we must set the performance threshold according to section 1848(q)(6)(D)(i) of the Act at the mean or median of the final scores for all MIPS eligible clinicians for a prior period.
After consideration of the public comments, we are finalizing at § 414.1405(b) that a performance threshold will be specified for each MIPS payment year. Specifically, we are finalizing a performance threshold of 3 points for the 2019 MIPS payment year in accordance with the special rule set forth in section 1848(q)(6)(D)(iii) of the Act. We believe this approach to establishing the performance threshold will enable more robust and thorough engagement with the program over time consistent with our goal for a transition year. As noted above, however, we intend to increase the performance threshold in year 2, and beginning in year 3 we will use the mean or median final score from a prior period as required by section 1848(q)(6)(D)(i) of the Act.
In addition to the performance threshold, section 1848(q)(6)(D)(ii) of the Act requires the Secretary to compute, for each year of the MIPS, an additional performance threshold for purposes of determining the additional MIPS payment adjustment factors for exceptional performance under paragraph (C). For each such year, the Secretary shall apply either of the following methods for computing the additional performance threshold: (1) The threshold shall be the score that is equal to the 25th percentile of the range of possible final score above the performance threshold determined under section 1848(q)(6)(D)(i) of the Act; or (2) the threshold shall be the score that is equal to the 25th percentile of the actual final score for MIPS eligible clinicians with final score at or above the performance threshold for the prior period described in section 1848(q)(6)(D)(i) of the Act.
For each year of the MIPS, we will compute an additional performance threshold for purposes of determining the additional MIPS payment adjustment factors under section 1848(q)(6)(C) of the Act. We proposed at § 414.1405(e) the following methods for computing the additional performance threshold: The threshold shall be equal to the 25th percentile of the range of possible final score above the performance threshold; or it shall be equal to the 25th percentile of the actual final score for MIPS eligible clinicians with final scores at or above the performance threshold for the prior period used to determine the performance threshold.
As discussed above, section 1848(q)(6)(D)(iii) of the Act outlines a special rule for establishing the additional performance threshold for the initial 2 years of MIPS. Because 2019 is the first MIPS payment year, we do not have any actual final score for MIPS eligible clinicians to use for purposes of defining an additional performance threshold under the methodology proposed above. Therefore, we proposed to establish the additional performance threshold at the 25th percentile of the range of possible final scores above the performance threshold. For example, if the performance threshold is 60, then the range of possible final scores above the performance threshold would be 61-100. The 25th percentile of those possible values is 70. We intended to publish the additional performance threshold with the performance threshold prior to the performance period.
The following is a summary of the comments we received regarding our proposal to establish the additional performance threshold at the 25th percentile of the range of possible final scores above the performance threshold for exceptional performance.
After consideration of the public comments, we are codifying at § 414.1305 the definition of additional performance threshold as the numerical threshold for a MIPS payment year against which the final scores of MIPS eligible clinicians are compared to determine the additional MIPS payment adjustment factors for exceptional performance. We are also finalizing at § 414.1405(d) that an additional performance threshold will be specified for each of the MIPS payment years 2019 through 2024. Specifically, the additional performance threshold for the 2019 MIPS payment year is 70 points.
Section 1848(q)(6)(F)(i) of the Act provides, for positive MIPS payment adjustment factors for MIPS eligible clinicians whose final score is above the performance threshold under paragraph (D)(i) for such year, the Secretary shall increase or decrease such adjustment factors by a scaling factor (not to exceed 3.0) to ensure that the budget neutrality requirement of clause (ii) is met. Stated generally, budget neutrality as required by section 1848(q)(6)(F)(ii) of the Act means the estimated increase in the aggregate allowed charges resulting from the application of positive MIPS payment adjustment factors under section 1848(q)(6)(A) of the Act (after application of the scaling factor) is equal to the estimated decrease in the aggregate allowed charges resulting from the application of negative MIPS payment adjustment factors under section 1848(q)(6)(A) of the Act. Under section 1848(q)(6)(F)(iii) of the Act, budget neutrality requirements shall not apply if all MIPS eligible clinicians receive final scores for a year that are below the performance threshold under paragraph (D)(i) for such year, or if the maximum scaling factor (3.0) is applied for a year. We are codifying at § 414.1405(b)(3) that a scaling factor not to exceed 3.0 may be applied to positive MIPS payment adjustment factors to ensure budget neutrality such that the estimated increase in aggregate allowed charges resulting from the application of the positive MIPS payment adjustment factors for the MIPS payment year equals the estimated decrease in aggregate allowed charges resulting from the application of negative MIPS payment adjustment factors for the MIPS payment year.
Section 1848(q)(6)(C) of the Act requires, for each of the years 2019 through 2024, the Secretary to specify an additional MIPS payment adjustment factor for each MIPS eligible clinician whose final score for a year is at or above the additional performance threshold established under paragraph (D)(ii) for that year. This additional adjustment factor is required to take the form of a percentage and to be determined by the Secretary such that MIPS eligible clinicians with higher final scores above the additional performance threshold receive higher additional MIPS payment adjustment factors. Section 1848(q)(6)(F)(iv)(I) of the Act provides, in specifying the additional adjustment factors under paragraph (C) for each applicable MIPS eligible clinician for a year, the Secretary shall ensure that the estimated aggregate increase in payments under Medicare Part B resulting from the application of such additional adjustment factors shall be equal to $500,000,000 for each year beginning with 2019 and ending with 2024. We refer to the $500,000,000 increase in payments as aggregate incentive payments. Section 1848(q)(6)(F)(iv)(II) of the Act provides that the additional adjustment factor for each applicable MIPS eligible clinician shall not exceed 10 percent, which may result in an aggregate increase in payments that is less than $500,000,000 as described in subclause (I).
To be consistent with the MIPS payment adjustment factors under section 1848(q)(6)(A) of the Act, we proposed to apply a linear sliding scale where MIPS eligible clinicians with a final score at the additional performance threshold would receive 0.5 percent additional adjustment factor and MIPS eligible clinicians with a final score equal to 100 would receive a 10 percent maximum additional adjustment factor. Similar to the adjustment factor, we would apply a scaling factor that is greater than 0 and less than or equal to 1.0 if needed to ensure distribution of the $500,000,000 increase in payments. The scaling factor must be greater than 0 to ensure that MIPS eligible clinicians with higher final scores receive a higher additional adjustment factor. The scaling factor cannot exceed 1.0; the 10 percent maximum additional adjustment factor could only decrease and not increase because section 1848(q)(6)(F)(iv)(II) of the Act provides that the additional adjustment factor shall not exceed 10 percent. We proposed the starting point for the additional adjustment factor at 0.5 percent for a final score at the additional performance threshold because this would provide a large enough incentive for MIPS eligible clinicians to strive for the additional performance threshold, while still providing the opportunity for a positive slope on the linear sliding scale. If we are unable to achieve a linear sliding scale starting at 0.5 percent (because the estimated aggregate increase in payments for a year would exceed $500 million), then we proposed to lower the starting percentage for a final score at the additional performance threshold until we are able to create the linear sliding scale with a scaling factor greater than 0 and less than or equal to 1.0. A MIPS eligible clinician with a final score that is below the additional performance threshold would not be eligible for an additional adjustment factor. We requested comments on these proposals.
The following is summary of the comments we received regarding the additional adjustment factor.
After consideration of the public comments, we are finalizing our proposal at § 414.1405(d)(1), MIPS eligible clinicians with a final score at or above the additional performance threshold receive an additional MIPS payment adjustment factor for exceptional performance on a linear sliding scale such that an additional adjustment factor of 0.5 percent is assigned for a final score at the additional performance threshold and an additional adjustment factor of 10 percent is assigned for a final score of 100, subject to the application of a scaling factor as determined by CMS, such that the estimated aggregate increase in payments resulting from the application of the additional MIPS payment adjustment factors for the MIPS payment year shall not exceed $500,000,000 for each of the MIPS payment years 2019 through 2024.
Section 1848(q)(6)(E) of the Act provides that for items and services furnished by a MIPS eligible clinician during a year (beginning with 2019), the amount otherwise paid under Part B for such items and services and MIPS eligible clinician for such year, shall be multiplied by 1 plus the sum of the MIPS payment adjustment factor determined under section 1848(q)(6)(A) of the Act divided by 100, and as applicable, the additional MIPS payment adjustment factor determined under section 1848(q)(6)(C) of the Act divided by 100. We would apply the adjustment factors in accordance with section 1848(q)(6)(E) of the Act.
We requested comment on our proposals.
The following is summary of the comments we received regarding our proposal to apply the MIPS payment adjustment factors for items and services furnished by a MIPS eligible clinician during a year in accordance with section 1848(q)(6)(E) of the Act.
After consideration of the public comments, we are finalizing our proposed application of the MIPS payment adjustment factors at § 414.1405(e). For each MIPS payment year, the MIPS payment adjustment factor, and if applicable the additional MIPS payment adjustment factor, are applied to Medicare Part B payments for items and services furnished by the MIPS eligible clinician during the year.
Figure A of the proposed rule, provided an example of how various final scores would be converted to an adjustment factor and potentially an additional adjustment factor, using the statutory formula. We direct readers to 81 FR 28276 for an illustration of the proposed policies.
Figure A in this final rule with comment period shows an illustrative picture based on the final policies. In Figure A, the performance threshold is 3 points. The applicable percentage is 4 percent for 2019. The adjustment factor is determined on a linear sliding scale from zero to 100, with zero being the lowest negative applicable percentage (negative 4 percent for 2019), and 100 being the highest positive applicable percentage. However, there are two modifications to this linear sliding scale. First, there is an exception for a final score between 0 and
Figure A of this final rule with comment period illustrates an example slope. In this example, the scaling factor for the adjustment factor is 0.214, which is much lower than 1.0. MIPS eligible clinicians with a final score equal to 100 would have an adjustment factor of 0.856 percent (4.0 percent × 0.214).
The additional performance threshold is 70 points. An additional adjustment factor of 0.5 percent starts at the additional performance threshold and increases on a linear sliding scale up to 10 percent times a scaling factor that is greater than 0 and less than or equal to 1.0. In Figure A of this final rule with comment period, the example scaling factor for the additional adjustment factor is 0.1523. Therefore, MIPS eligible clinicians with a final score of 100 would have an additional adjustment factor of 1.523 percent (10 percent × 0.1523). The total adjustment for a MIPS eligible clinician with a final score equal to 100 would be 1 + 0.00856 + 0.01523 = 1.02379, for a total positive MIPS payment adjustment of 2.379 percent. Note that in calculating payment adjustments, we will not round any numbers until the final step of the process. After we have calculated the total adjustment for a MIPS eligible clinician, we will round the percentage upward or downward to one decimal point. Thus, a total adjustment of 1.02379 will be rounded to a positive payment adjustment of 2.4 percent.
The adjustment factor for final score values above the performance threshold is illustrative. For MIPS eligible clinicians with a final score of 100, the adjustment factor would be 4 percent times a scaling factor greater than 0 and less than or equal to 3.0. The scaling factor is intended to ensure budget neutrality, but cannot be higher than 3.0. The additional adjustment factor is also illustrative. The additional adjustment factor starts at 0.5 percent and cannot exceed 10 percent. MIPS eligible clinicians at or above the additional performance threshold will receive the amount of the adjustment factor plus the additional adjustment factor.
The final MIPS payment adjustments would be determined by the distribution of final scores across MIPS eligible clinicians and the performance threshold. More MIPS eligible clinicians above the performance threshold means the scaling factors would decrease because more MIPS eligible clinicians receive a positive MIPS payment adjustment. More MIPS eligible clinicians below the performance threshold means the scaling factors would increase because more MIPS eligible clinicians would have negative MIPS payment adjustments and relatively fewer MIPS eligible clinicians receive positive MIPS payment adjustments.
We requested comment on these examples, but we did not receive any comments on them. We have however provided in Table 31 a summary of the MIPS payment adjustments based on different final scores.
We have provided the following examples to demonstrate to readers how the MIPS calculations and performance threshold of 3 points will operate for various performance scenarios.
As discussed in section II.E.6.a.(4) of this final rule with comment period, different improvement activities scoring rules apply to a solo practitioner (or small group) than apply to groups of 16 or more clinicians. Under these special scoring rules, a solo practitioner who performs one medium-weighted activity receives 20 out of 40 potential points in the improvement activities performance category score, and one who performs one high-weighted activity receives 40 out of 40 of the improvement activities performance category score. The improvement activities performance category score is weighted as 15 percent of the final score. In this example, the MIPS eligible clinician that is a solo practitioner who performs only one medium-weighted activity, which equals 20 out of the 40 possible points, or 50 percent, for the improvement activities performance category score, which has a weight of 15 percent of the final score. The MIPS eligible clinician's total improvement activities performance category score is 7.50 (50 percent × 15 =7.50).
For advancing care information performance category scoring, the eligible clinician submits the required elements of the base for advancing care information only which is worth 50 percent of the advancing care information performance category score. The advancing care information performance category is worth 25 percent of the final score. In this scenario, the eligible clinician would receive an advancing care information score of (50 percent × 25) =12.5.
As a result, the total final score = 3 +7.5+12.5= 23.0 points which is above the performance threshold of 3 points.
As discussed in section II.E.6.a.(4) of this final rule with comment period, different improvement activities scoring rules apply to a solo practitioner (or small group) than apply to groups of 16 or more clinicians. Under these special scoring rules, a solo practitioner who performs one medium-weighted activity receives 20 out of 40 potential points in the improvement activities performance category score, and one who performs one high-weighted activity receives 40 out of 40 of the improvement activities performance category score. The improvement activities performance category score is weighted as 15 percent of the final score. In this example, the MIPS eligible clinician performs two medium-weighted activities, which
Under this scenario, the MIPS eligible clinician's final score is 56 for the quality performance category score +15 for the improvement activities performance category score + 0 for advancing care information performance category score = 71 points which is above the additional performance threshold of 70.
We cannot guarantee that establishing the performance threshold of 3 for the transition year will always provide a positive MIPS payment adjustment for MIPS eligible clinicians; however, it does provide more opportunities for MIPS eligible clinicians to participate and become familiar with MIPS. In addition, the additional adjustment factor provides incentives for MIPS eligible clinicians to strive for good performance.
Through the MIPS and APMs RFI, we solicited comment on various questions related to performance feedback under section 1848(q)(12) of the Act, such as what type of information should be contained in the performance feedback data, how often the feedback should be made available, and who should be able to access the data. Several commenters stated that it would be beneficial if the performance feedback under MIPS contained all the data that contributes to an EP's final score and any MIPS adjustment. Further, several commenters suggested that performance feedback allow for interactive use of the data. Commenters supported frequent availability of such data and many noted that a minimum of quarterly feedback data would be preferred. Commenters also noted that access to PQRS feedback reports currently was a challenge and some suggested that the EPs should be able to control who can access the feedback reports.
Under section 1848(q)(12)(A)(i) of the Act, as added by section 101(c)(1) of the MACRA, we are at a minimum required to provide MIPS eligible clinicians with timely (such as quarterly) confidential feedback on their performance under the quality and cost performance categories beginning July 1, 2017, and we have discretion to provide such feedback regarding the improvement activities and advancing care information performance categories.
Beginning July 1, 2017, we proposed to include information on the quality and cost performance categories in the performance feedback. Within these performance categories, we proposed to use fields similar (that is, quality and cost) to those currently available in the Quality and Resource Use Reports (QRURs). Since the QRURs already provide information on quality and cost we believe this is a good starting point for the data fields to be included in the performance feedback. Additional information on the current QRURs can be found at
The first performance feedback is due on July 1, 2017. As this is prior to us having received any MIPS data, we proposed to initially provide feedback to MIPS eligible clinicians who are participating in MIPS using historical data set(s), as available and applicable. For example, these historical data set(s) could be a baseline report, using data based off performance that occurred in CY 2015 or CY 2016 for applicable and available quality and cost data. Since 2017 is the first MIPS performance period (as finalized in section II.E.8.a.), we do not anticipate receiving the first set of data for MIPS until 2018 (see 81 FR 28181). At a minimum for the transition year, we proposed to provide performance feedback on an annual basis since the first performance feedback, required on July 1, 2017 would be based on historic data set(s). As the program evolves, and we can operationally assess/analyze the MIPS data, we may consider in future years providing performance feedback on a more frequent basis, such as quarterly. Section 1848(q)(12)(A)(i) of the Act requires the performance feedback to be provided “timely” (such as quarterly), which is our goal as MIPS evolves. In addition, we solicited comments on whether we should include first year measures in the performance feedback, meaning new measures that have been in use for less than 1 year, regardless of submission methods. The reasoning behind first-year measures potentially not being reported is we need to review the data from the measures before these data are incorporated into performance feedback, as we want to ensure the data we are providing in the performance feedback is useful and actionable for our stakeholders. We requested comments on these proposals.
In future years and as the program evolves, we intend to seek comment on the template, including but not limited to the data fields, for performance feedback. While section 1848(q)(12)(A)(i) of the Act only requires us to provide performance feedback for the quality and cost performance categories, we understand
The following is a summary of the comments we received regarding our proposal to provide annual performance feedback on the quality and cost performance categories starting July 1, 2017, which would be based on historic/baseline information and include fields similar to QRURs.
With regard to the frequency of providing performance feedback, commenters' suggestions ranged from annually to 6 weeks of the performance period. The majority of commenters stated that annual feedback would not provide timely information or frequent feedback, due to the long look-back periods hindering the ability for improvements of care. Many commenters supported real-time feedback to eligible clinicians and groups, and suggested making feedback available during the performance periods so clinicians could correct errors in a timely fashion. The majority of comments supported quarterly feedback from CMS, some commenters noting this should begin in 2017. One commenter requested that CMS adopt a requirement that eligible clinicians be furnished quarterly feedback on the advancing care information performance category during the performance period.
One commenter stated that 6 months is the ideal target to provide feedback, to allow for unavoidable claim run-out and review processes. While some commenters supported a monthly performance feedback so adjustments could be made in workflow to improve performance. Another commenter noted that performance feedback should be provided no later than 45 days following the end of a performance period. One commenter requested that performance feedback be available and accessible upon request. One commenter recommended that CMS allow eligible clinicians to choose if they want to receive more current feedback, such as quarterly.
Another commenter recommended that performance feedback be provided prior to the end of the performance period. Other commenters suggested that the final performance feedback is provided no later than October 1 of the reporting year. Another commenter expressed that performance feedback to eligible clinicians would only be effective if it would come in time to make meaningful changes to the practice, and that subsequently July 1 was too late in the year for feedback.
Some commenters believed there is value in submitting data more frequently (for example, an iterative process where practices and vendors submit data routinely); but if CMS intends to provide feedback after eligible clinicians submit their data and not on a frequent basis, then eligible clinicians should not be required to submit data more frequently.
Another commenter recommended an approach that allows for timely, actionable feedback, such as the Bundled Payments for Care Improvement (BPCI) model, which offers monthly data files and quarterly reconciliation reports with subsequent true-ups.
One commenter noted that clinicians need real-time information, including attribution for cost to perform well and achieve the Quality Payment Program's goals. One commenter requested that
Some commenters recommended that CMS provide the ability for eligible clinicians and organizations to run real-time cost measure reports on the CMS Web site, as waiting for CMS to publish mid-year or even quarterly reports does not provide sufficient time to design and implement improvement interventions.
One commenter encouraged CMS to provide cost performance feedback that makes it possible for the data to be incorporated into other reporting and analytics tools the clinician might be using and allows the clinician to monitor their scores throughout the reporting period.
Additionally, section 1848(q)(12)(B)(i) of the Act, states that beginning July 1, 2018, the Secretary shall make available to MIPS eligible clinicians information about the items and services for which payment is made under Title 18 that are furnished to individuals who are patients of MIPS eligible clinicians by other suppliers and providers of services. This information may be made available through mechanisms determined appropriate by the Secretary. We agree this information would be useful to eligible clinicians, and are therefore targeting to include this information in the performance feedback beginning July 1, 2018.
One commenter requested that CMS continue to provide timely mid-year and end-of-year QRURs to eligible clinicians in order for them to receive timely feedback about their performance and payment adjustments under MIPS. Some commenters supported quicker and broader access to performance scores and “feedback reports” such as those provided to clinicians as part of the Physician Feedback Program (QRURs), and the Medicare Shared Savings Program for ACOs for quality improvement purposes. One commenter suggested the QRURs be provided on a quarterly basis moving forward with the Quality Payment Program so the information is timely for performance feedback.
One commenter noted concerns with the implementation feasibility of getting performance feedback out for mid-year performance given past experience with the PQRS and QRURs, and urged CMS to make the investments needed in resources and systems to ensure timely feedback.
One commenter requested that CMS expedite the performance feedback process so that partial‐year data on performance in the transition year of the MIPS is available to physicians prior to July 1, 2018—and preferably prior to January 1, 2018.
After consideration of the comments, we are finalizing that we will use the QRUR released on September 26, 2016 (referred to as the 2015 Annual QRUR) as the first MIPS performance feedback provided under section 1848(q)(12)(A)(i) of the Act, which will contain quality and cost data. The September 2016 QRURs are available and can be accessed at
Lastly, we note that these QRURs are produced at the TIN level, which is the level for applying adjustments under the VM program. We recognize that assessments under MIPS may be conducted at either the individual or group level, and that payment adjustments will be made at the TIN/NPI level; therefore, QRURs may not provide sufficient detail for those clinicians who are currently assessed at the TIN level under the VM, but who may choose to be assessed at the individual level under the Quality Payment Program. To address this issue, we intend, prior to the 2018 performance period, to provide as much feedback as technically possible to clinicians at the individual level. Since at this time CMS will not have performance data for the 2017 performance period (as that data is not yet available), we will not be able to provide feedback on that data. We intend to look into providing feedback to clinicians on the data it does have available, for instance, on claims based cost data or claims based outcome measures.
The September 26, 2016 QRURs show how physician groups and physician solo practitioners performed in 2015 on quality and cost measures relative to national benchmarks and indicate whether physicians will receive an upward, neutral or downward adjustment under the VM in 2017. The QRURs also contain important information about care delivered to Medicare beneficiaries that can be used to better understand and improve quality and cost performance under the VM including information about hospitalizations and other providers that can be used to improve quality and better coordinate care.
By utilizing an already existing report, that provides quality and resource use (for example, cost) feedback, we intend to focus resources on continued user testing with front-line clinicians and other stakeholders and development of new and improved methods and mechanisms for performance feedback, including but not limited to those suggested in these comments. We are utilizing an existing report because it does not make sense for us to create a duplicative report containing the same information and provide it to clinicians beginning July 1, 2017, which would only confuse clinicians by continuing to use the same data as provided in the September 26, 2016 QRUR. Additionally, no clinicians would have submitted data for the Quality Payment Program to us before July 1, 2017. Therefore, we intend to invest our resources in creating an easy to understand and meaningful performance feedback for the Quality Payment Program beginning July 1, 2018.
We note, however, that we expect to provide the 2016 annual QRUR in early fall 2017 that will show how groups and solo practitioners performed in 2016 on the quality and cost measures used to calculate the 2018 VM, as well as their 2018 VM payment adjustment. The 2016 annual QRUR will be the last annual QRUR provided to groups and solo practitioners, as the VM program is sunsetting. We believe the 2016 annual QRUR is important to provide ongoing feedback to clinicians and groups to support their successful transition to the Quality Payment Program.
Further we note that in the next performance feedback, we intend to provide performance feedback for MIPS data collected in 2017. This data could potentially include all applicable data reflecting CY 2017 performance, including data on the quality and cost performance categories; as well as, data regarding the final score and payment adjustment. This reflects our commitment to providing as timely information as possible to eligible clinicians in order to help them predict their performance in MIPS. CMS intends for this performance feedback to be available in the new format for the 2017 performance period by summer 2018, after the 2017 reporting closes.
In addition, we solicited comments on whether we should include first year measures in the performance feedback, meaning new measures that have been in use for less than 1 year, regardless of submission methods. We also solicited comments on including the final score in performance feedback as the program evolves. The following is a summary of the comments we received.
For detailed information regarding first year measures and public reporting on Physician Compare, we refer commenters to section II.E.10. of this final rule with comment period.
We have considered the comments received and will take them into consideration in the future development of performance feedback through separate notice-and-comment rulemaking.
In the proposed rule, we proposed that MIPS eligible clinicians who participate in MIPS APM Entities would receive performance feedback, as technically feasible (81 FR 28247). A summary of comments on those proposals can be found in section II.E.5.h.(16) of this final rule with comment period.
Under section 1848(q)(12)(A)(ii) of the Act, the Secretary may use one or more mechanisms to make performance feedback available, which may include use of a web-based portal or other mechanisms determined appropriate by the Secretary. For the quality performance category, described in section 1848(q)(2)(A)(i) of the Act, the feedback shall, to the extent an eligible clinician chooses to participate in a data registry for purposes of MIPS (including registries under sections 1848(k) and (m) of the Act), be provided based on performance on quality measures reported through the use of such registries. For any other performance category (that is, cost, improvement activities, or advancing care information), the Secretary shall encourage provision of feedback through qualified clinical data registries (QCDRs) as described in sections 1848(m)(3)(E) of the Act.
We understand that the PQRS and VM programs have employed various communication strategies to notify health care clinicians of the availability of their PQRS feedback reports and QRURs, respectively, through the CMS portal. However, many health care clinicians are still unaware of these reports and/or have difficulty accessing their reports in the portal. Further, we are aware that some health care clinicians perceive the current reports as complex and often difficult to understand; while others find the QRURs, and the drill down data included in them on the Medicare beneficiaries they serve, very useful. We are continuing to work with stakeholders to improve the usability of these reports. As we transition to MIPS, we are committed to ensuring that eligible clinicians are able to access their performance feedback, and that the data are easy to understand while providing information that will help drive quality improvement. We proposed to initially make performance feedback available using a CMS designated system, such as a web-based portal; and if technically feasible perhaps an interactive dashboard. As further discussed in the proposed rule (81 FR 28280), we also proposed to leverage additional mechanisms such as health IT vendors, registries, and QCDRs to help disseminate data/information contained in the performance feedback to eligible clinicians, where applicable. At this time, we believe that these additional mechanisms will only be able to provide information on the quality performance category for MIPS in regard to performance feedback.
We plan to coordinate with third party intermediaries such as health IT vendors and QCDRs as MIPS evolves to enable additional feedback to be sent on the cost, advancing care information and improvement activities performance categories. We solicited comment on this for future rulemaking.
Comments received through the MIPS and APMs RFI noted issues associated with access to the current feedback reports for PQRS. Specifically, comments were received noting issues with Enterprise Identity Management (EIDM) and access to the portal to view PQRS feedback reports. Commenters also noted the need for a mechanism to be put in place to notify EPs when their PQRS feedback report is available. We proposed to use the information contained in the provider or supplier's Medicare enrollment records, and stored in the Provider Enrollment, Chain, and Ownership System (PECOS), as the system of records for eligible clinicians' contact information that should be used when the MIPS performance feedback is available. It is therefore critical that eligible clinicians ensure that their Medicare enrollment records (especially in regard to phone and email contact information) are updated, meaning current, on a consistent basis in PECOS. If more than one email address is listed, then the email address that should be used for communication should be designated. We also intend to provide education and outreach on how to access performance feedback. We solicited comment on additional means that could be used to notify or contact MIPS eligible clinicians and groups
The following is a summary of the comments we received regarding our proposal to provide performance feedback through a CMS designated system (such as a web-based portal or interactive dashboard), and to leverage additional mechanisms such as health IT vendors, registries, and QCDRs to help disseminate data/information contained in the performance feedback to eligible clinicians, where applicable.
Many commenters recommended an interactive web-based dashboard for feedback delivery that provides data in real-time to eligible clinicians, at least on a quarterly basis. Some commenters recommended the display of such a dashboard show performance feedback through graphics. A few commenters recommended to not implement performance feedback for the quality and cost performance categories until CMS has had a chance to bring online a web portal where MIPS eligible clinicians can log in and see their final score. The commenters explained that without understanding how they are scoring versus their peers under MIPS, many may fall inadvertently to the bottom of the quality or cost performance categories.
One commenter recommended that CMS work with health IT vendors to develop a real-time feedback dashboard that can be incorporated into health IT products, such as EHRs, as eligible clinicians will not know where they are relative to the performance threshold on an annual basis until after the close of the performance period. While another commenter recommended that, to the extent it is feasible, CMS consider partnering with registry vendors to integrate reports in registry interfaces, enabling those eligible clinicians reporting via an EHR or QCDR to view performance feedback in a dashboard setting that is familiar to them.
Some commenters suggested that CMS create an electronic interactive tool for eligible clinicians to quickly gauge their progress by calculating scores, which can help eligible clinicians identify measures that are applicable to their practice. Another commenter noted that an important aspect for clinicians and groups in small, rural and underserved areas are intuitive tools to easily calculate their MIPS score, whether this tool is embedded within the health IT vendor, registry, or available on the CMS Web site. The commenter also stated that this must be a robust tool which would allow clinicians and groups the ability to securely visualize external data such as aggregate claims data used to calculate episode measures.
One commenter recommended performance feedback be available online and in a timely fashion, ideally in the way that the same information would be available to the public, but well in advance of publication. One commenter suggested CMS leverage the My Quality Net Web site to provide performance feedback to clinicians, since hospitals and other clinicians are already accustomed to using it for federal quality reporting programs.
Another commenter recommended that CMS create a clinician portal that will allow eligible clinicians and other clinicians to estimate their payment adjustment.
Some commenters requested that performance feedback provide the ability to drill down for use by individual physicians.
Another commenter agreed with utilizing vendors, such as registries, to communicate performance feedback in real-time so that performance can be monitored at any time. While another commenter recommended that CMS continue to evaluate and work with vendors to determine how health IT vendors and QCDRs can be leveraged to provide more ongoing performance feedback to clinicians, as the goal being an agile method of analyzing performance without manual entry or mistake. One commenter requested that CMS leverage advanced electronic reporting mechanisms to reduce the long feedback turnaround time in claims-based systems and to provide performance data on improvement activities and advancing care information in addition to quality and cost.
One commenter recommended that CMS provide third party intermediaries access to clinician performance feedback for the clinicians for whom they are submitting information for in order to allow third party intermediaries to validate and troubleshoot any issues with the data.
One commenter suggested that CMS allow clinicians to elect to receive their performance feedback through a Regional Healthcare Innovative Collaborative (RHIC) that are able to provide a multi-payer perspective.
One commenter agreed with offering clinicians the option to receive performance feedback through one channel, and requested that CMS make this a priority for future performance feedback years. The commenter also recommended that as part of this initiative, CMS work with stakeholders toward creating a channel for eligible clinicians to view their performance on both quality and cost measures across all (or multiple) payers. The commenter also noted that it is critical for eligible clinicians to have access to a resource that provides them with a complete picture of their practice across all payers.
Other commenters stated that many clinicians are unaware of the current QRURs or have had trouble accessing them, noting difficulty with the login process which they believed was being unnecessarily complicated, not always clear who has access, and those that have access are not usually front-line clinicians. The commenter strongly encouraged CMS to push performance feedback out to clinicians as opposed to waiting for clinicians to access the feedback.
After consideration of the comments we are finalizing these polices as proposed. In future years of the program, performance feedback will continue to be available through a CMS designated system, which we intend to be a web-based application. The intent is that in the next performance feedback, anticipated to be released around July 1, 2018, this feedback will be the first in the anticipated new dashboard format. It will be provided via the new Quality Payment Program portal and we intend to leverage additional mechanisms such as health IT vendors, registries, and QCDRs to help disseminate data/information contained in the performance feedback to eligible clinicians, where applicable. As we have stated previously, we will continue to engage in user research with front-line clinicians to ensure we are providing the performance feedback data in a user-friendly format, and that we are including the data most relevant to clinicians. For updates and more information, please see QualityPaymentProgram.cms.gov.
Additionally, we did not receive comments on our proposal to use the information contained in the provider or supplier's Medicare enrollment records, and stored in the Provider Enrollment, Chain, and Ownership System (PECOS), as the system of records for eligible clinicians' contact information that should be used when the MIPS performance feedback is available. Therefore, we are finalizing this policy as proposed.
We also sought comment for future rulemaking on coordinating with third party intermediaries such as health IT vendors and QCDRs as MIPS evolves to enable additional feedback to be sent on the cost, advancing care information and improvement activities performance categories. We did not receive comments on additional feedback that could be sent through third party intermediaries. We plan to work with third party intermediaries as we continue to develop the mechanisms for performance feedback, to see where we may be able to develop and implement efficiencies for the Quality Payment Program. Any regulatory changes would be made through future notice-and-comment rulemaking.
Under section 1848(q)(12)(A)(iii) of the Act, for purposes of providing performance feedback, the Secretary may use data, for a MIPS eligible clinician, from periods prior to the current performance period and may use rolling periods in order to make illustrative calculations about the performance of such professional. We believe “illustrative calculations” means an interim, snap shot in time of performance, or perhaps a “dry-run” of the data including measure rates. This would provide an indication of how a MIPS eligible clinician might be performing, but would not be conclusive. Since MIPS will not likely have comparable data until year 3 of the program, these “illustrative calculations” could be based on historical data sets available to CMS until actual data for MIPS is available.
We did not request comments in this section, but did receive a comment which is summarized below.
We have considered the comments received and will take them into consideration in the future development of performance feedback through separate notice-and-comment rulemaking.
As stated under section 1848(q)(12)(A)(iv) of the Act, feedback made available under section 1848(q)(12)(A) of the Act shall be exempt from disclosure under 5 U.S.C. 552 (the Freedom of Information Act) (FOIA).
We did not request comments in this section, but we received the following comment:
Section 1848(q)(12)(A)(v) of the Act, states that the Secretary may use the mechanisms established under section 1848(q)(12)(A)(ii) of the Act to receive information from professionals. This allows for expanded use of the feedback mechanism to not only provide feedback on performance to eligible clinicians, but to also receive information from professionals.
We intend to explore the possibility of adding this feature to the CMS designated system, such as a portal, in future years under MIPS. This feature could be a mechanism where MIPS eligible clinicians can send their feedback (that is, if they are experiencing issues accessing their data, technical questions about their data, etc.) to us. We appreciate that MIPS eligible clinicians may have questions regarding the information contained in their performance feedback. To assist MIPS eligible clinicians, we intend to establish resources, such as a helpdesk or offer technical assistance, to help address questions with the goal of linking these resource features to the CMS designated system, such as a portal.
Additionally, we solicited comment on the types of information eligible clinicians would like to send to us via this mechanism.
The following is a summary of the comments we received.
Other commenters requested that CMS guarantee firm turnaround times for performance feedback, and offer teleconferences to work with eligible clinicians in reviewing the patient data. While some commenters urged CMS to devote the necessary resources, including staff, to help clinicians and administrators interpret the performance feedback (for example, helpdesk).
One commenter recommended that CMS provide technical assistance to eligible clinicians to help understand performance feedback (for example, more practical and specific tips in the help documents for education and outreach, especially as this is a new program).
We have considered the comments received and will take them into consideration in the future development of performance feedback through separate notice-and-comment rulemaking.
Section 1848(q)(12)(B)(i) of the Act, states that beginning July 1, 2018, the Secretary shall make available to MIPS eligible clinicians information about the items and services for which payment is made under Title 18 that are furnished to individuals who are patients of MIPS eligible clinicians by other suppliers and providers of services. This information may be made available through mechanisms determined appropriate by the Secretary, such as the proposed CMS designated system that would also provide performance feedback. Section 1848(q)(12)(B)(ii) of the Act specifies that the type of information provided may include the name of such providers, the types of items and services furnished, and the dates items and services were furnished. Historical data regarding the total, and components of, allowed charges (and other figures as determined appropriate by the Secretary) may also be provided. We solicited comment on the type of information MIPS eligible clinicians would find useful and the preferred mechanisms to provide such information, as well as, arrangements that should be in place regarding these data (that is, eligible clinicians sharing data). We also solicited comment as to whether additional information regarding beneficiaries attributed to a MIPS eligible clinician under the cost performance category or information about which MIPS eligible clinician(s) beneficiaries to whom a given MIPS eligible clinician provides services were attributed would be useful feedback in regards to quality improvement efforts.
The following is a summary of the comments we received.
We have considered the comments received and will take them into consideration in the future development of performance feedback through separate notice-and-comment rulemaking.
The performance feedback under section 1848(q)(12)(A) of the Act is meant to be meaningful and usable to eligible clinicians. In an effort to ensure these data are tailored to the needs of eligible clinicians, we solicited comment through the MIPS and APMs RFI and received numerous comments regarding overall format of the performance feedback template. Suggestions were made on what this feedback should include for MIPS. We intend to collaborate with stakeholders outside of notice-and-comment rulemaking on how the performance feedback should look for MIPS; as well as, what data elements would be useful for eligible clinicians.
We solicited comment on the fields that should be included in the performance feedback template for MIPS eligible clinicians. The following is a summary of the comments we received.
One commenter suggested that other information could be used in performance feedback by providing data on alternatives to the items or services provided that would have been more cost effective while delivering the same quality of care. Some commenters requested that CMS provide individual eligible clinician and group performance feedback in order to help eligible clinicians determine whether to continue reporting with the group or change to individual reporting.
Another commenter recommended that performance feedback include improved transparency, and additional data points for each reported measure. One commenter recommended that the performance feedback would show both scoring and decile placement for individual eligible clinicians across the areas scored. One commenter believes that all reported measures should be included in performance feedback, and every field that contributed to the score should be included as well. Some commenters suggested performance feedback include data fields that would assist with identification of patients served, costs, outcomes, where and what type of care was provided, quality of care for patients, and care coordination activities and needs; and functionality to compare (for example, regionally and nationally) directly against other eligible clinicians. One commenter suggested more relevant non-patient facing specialties be included in performance feedback.
Some commenters suggested performance feedback include the place of service (POS) codes, geography (including state and Medicare locality), health system NPI, the subpart NPI where the services were delivered, and the NPI of the entity receiving assignment for professional services; as well as the ability to include additional identifiers if needed in the future to account for specialties. While another commenter recommended performance feedback include information for suggested areas where the eligible clinician can improve, which promotes quality and helps eligible clinicians avoid penalties. Other commenters recommended that the cause for a penalty be clearly articulated.
Some commenters suggested performance feedback include as much data as possible as long as it is easy to understand, and recommended options for the format of performance feedback. Some commenters recommended a basic report containing the following information: performance threshold to date, where the clinician stands in performance, current possible payment adjustments (with exact reasoning for negative payment adjustment in order to improve for future reporting), and a roadmap to improve performance and avoid a downward adjustment. Some commenters recommended CMS use one comprehensive document for the MIPS performance feedback. Some commenters suggested a second report be included in the performance feedback on a more granular level, and contain MIPS specific components. Commenters also suggested that CMS put certain data in supplemental materials (for example, advancing care information) or appendices so that it does not detract from the main report for performance feedback.
One commenter suggested that CMS issue an advancing care information experience report similar to the annual PQRS Experience Report with as much information as possible, including reporting experiences by specialty. The commenter noted that CMS could include information on whether each objective was met/not met for the base score; performance data on the objectives being assessed for the performance score; and whether an eligible clinician or group earned bonus points for each measure reported under the Public Health and Clinical Data Registry Reporting objective other than the Immunization Registry Reporting measure. Another commenter recommended that feedback for the advancing care information category include the objectives in which the practice attested for the previous reporting period and the points attributed to those objectives for purposes of calculating the composite score.
A commenter recommended that CMS provide aggregate information by specialty to medical societies, as specialty societies do not have access to QRUR information at the individual clinician level or in aggregate, so they cannot provide meaningful analysis of current cost measures and assistance to clinician members. Another commenter requested that CMS provide additional data to support performance improvement efforts, because while the QRUR provides some ability to drill down into the data, the reports only provide patient-level expenditure data at the aggregate level compared to national benchmarks. While another commenter noted that performance feedback should include sufficient details on what patients and care have been attributed to the clinician and what other clinicians have partnered in that care.
One commenter requested detailed performance feedback highlighting options for improvement activities, discussing incorrect reporting, and include geographical components to allow eligible clinicians to review geographical variations in care processes to acclimate eligible clinicians to this new reporting category. Another commenter recommended that
Some commenters suggested that CMS should make available performance feedback to eligible clinicians on their high-utilization patients in as close to real time as possible or provide practices with reports similar to the Hospital Readmission Reductions Program. Another commenter requested that CMS provide files to clinician practices similar to what are provided to hospitals for the Medicare Spend Per Beneficiary measure that is part of Hospital Value-Based Purchasing.
Some commenters suggested that performance feedback be available via paper reports. Another commenter suggested that performance feedback be provided in an importable form such as a worksheet as opposed to a PDF file, which would allow the eligible clinician more options when reviewing with other tools already in use by the eligible clinician. While other commenters noted performance feedback should be provided in a format that allows eligible clinicians to sort, analyze, and review.
We intend to do as much as we can of the development of the template for performance feedback by working with the stakeholder community in a transparent manner. We think this will both encourage stakeholder commentary and make sure we end up with the best possible format(s) for feedback. CMS intends for this performance feedback to be available in the new format on the 2017 performance period by summer 2018, after the 2017 reporting closes.
We have considered the comments received and will take them into consideration in the future development of performance feedback through separate notice-and-comment rulemaking.
Section 1848(q)(7) of the Act requires that under the MIPS, the Secretary shall, not later than 30 days prior to January 1 of the year involved, make available to MIPS eligible clinicians the MIPS payment adjustment factor (and, as applicable, the additional MIPS payment adjustment factor) applicable to the MIPS eligible clinician for items and services furnished by the professional for such year. The Secretary may include such information in the confidential feedback under section 1848(q)(12) of the Act.
If technically feasible, we proposed to include the MIPS payment adjustment factor and, as applicable, the additional MIPS payment adjustment factor (collectively referred to as the “MIPS payment adjustment factors”) in the performance feedback for eligible clinicians provided under section 1848(q)(12)(A) of the Act. If it is not technically feasible to provide this information in the performance feedback, we proposed to make it available through another mechanism as determined appropriate by the Secretary (such as a portal or a CMS designated Web site) and solicited comment on mechanisms that might be appropriate. The first announcement will be available no later than December 1, 2018 to meet statutory requirements. We requested comment on these proposals.
The following is summary of the comments we received regarding our proposal to include the MIPS payment adjustment factors in the performance feedback, if technically feasible.
After consideration of the comments we are finalizing the policy as proposed that if technically feasible we will include the MIPS payment adjustment factors in the performance feedback. If it is not technically feasible to include the MIPS payment adjustment factors in the performance feedback, we will notify MIPS eligible clinicians through guidance documents or other program communication channels as to when and how this information will be announced prior to the statutory deadline of December 1, 2018. As discussed above, in future years of the program, performance feedback will be available via a CMS designated system, which we intend to be a web-based application. We also anticipate the announcement of the adjustment factors will be available via a web-based
Section 1848(q)(13)(A) of the Act requires the establishment of a process under which a MIPS eligible clinician or group may seek an informal review of the calculation of the MIPS payment adjustment factor (or factors) applicable to such MIPS eligible clinician or group for a year.
We recognize that a principled approach to requesting and conducting a targeted review is required under the MACRA to minimize burdens on MIPS eligible clinicians or groups and ensure transparency under MIPS. We also believe it is important to retain the flexibility to modify MIPS eligible clinicians' or groups' final score or MIPS payment adjustment based on the results of targeted review. This will lend confidence to the determination of the final score and MIPS payment adjustments, as well as, providing finality for the MIPS eligible clinician or group after the targeted review is completed. It will also minimize the need for claims reprocessing. We proposed an approach below that outlines the factors that we would use to determine if a targeted review may be conducted. In keeping with the statutory direction that this process be “informal,” we have attempted to minimize the associated burden on the MIPS eligible clinician to the extent possible.
In accordance with section 1848(q)(13)(A) of the Act, we proposed at § 414.1385 to adopt a targeted review process under MIPS wherein a MIPS eligible clinician or group may request we review the calculation of the MIPS payment adjustment factor under section 1848(q)(6)(A) of the Act and, as applicable, the calculation of the additional MIPS payment adjustment factor under section 1848(q)(6)(C) of the Act applicable to such MIPS eligible clinician or group for a year. Because this review will be limited to the calculation of the MIPS payment adjustment factor and, as applicable, the additional MIPS payment adjustment factor, we anticipate we may find it necessary to review data related to the measures and activities and the calculation of the final score according to the defined methodology. The following are examples of circumstances under which a MIPS eligible clinician or group may wish to request a targeted review. This is not a comprehensive list of circumstances:
• The MIPS eligible clinician or group believes that measures or activities submitted to us during the submission period and used in the calculations of the final score and determination of the adjustment factors have calculation errors or data quality issues. These submissions could be with or without the assistance of a third party intermediary; or
• The MIPS eligible clinician or group believes that there are certain errors made by us, such as performance category scores were wrongly assigned to the MIPS eligible clinician or group (for example, the MIPS eligible clinician or group should have been subject to the low-volume threshold exclusion and should not have received a performance category score).
We believe that a fair targeted review request process requires accessibility to all MIPS eligible clinicians or groups within a reasonable period of time and provides electronic and telephonic communication for questions regarding the targeted review process, as well as for the actual request for review and receipt of the decision on that request. The targeted review process will use the same Quality Payment Program Service Center (referred to as the “help desk” in the proposed rule) support mechanism as is provided for MIPS as a whole.
We further proposed at § 414.1385 to adopt the following general process for targeted reviews under section 1848(q)(13)(A):
• A MIPS eligible clinician or group electing to request a targeted review may submit their request within 60 days (or a longer period specified by us) after the close of the data submission period. All requests for targeted review must be submitted by July 31 after the close of the data submission period or by a later date that we specify in guidance.
• We will provide a response with our decision on whether or not a targeted review is warranted. If a targeted review is warranted, the timeline for completing that review may be dependent on the number of reviews requested (for example, multiple reviews versus a single review by one MIPS eligible clinician or group) and general nature of the review.
• As this process is informal and the statute does not require a formal appeals process, we will not include a hearing process. The MIPS eligible clinician or group may submit additional information to assist in their targeted review at the time of request. If we or our contractors request additional information from the MIPS eligible clinician or group, the supporting information must be received from the MIPS eligible clinician or group by us or our contractors within 10 calendar days of the request. Non-responsiveness to the request for additional information will result in the closure of that targeted review request, although another review request may be submitted if the targeted review submission deadline has not passed.
• Since this is an informal review process and given the limitations on review under section 1848(q)(13)(B) of the Act, decisions based on the targeted review will be final, and there will be no further review or appeal.
If a request for targeted review is approved, the outcome of such review may vary. For example, we may determine that the clinician should have been excluded from MIPS, re-distribute the weights of certain performance categories within the final score (for example, if a performance category should have been weighted at zero), or recalculate a performance category score in accordance with the scoring methodology for the affected category, if technically feasible.
We requested comments on these proposals.
The following is summary of the comments we received regarding our proposals for a targeted review process.
One commenter stated that clinician experiences with the informal review processes in PQRS and the physician value-based payment modifier have been frustrating. Further, it has been difficult to understand why requests for review were denied. The commenter suggested that CMS create a transparent, effective review process.
Additionally, we regret the frustrations stakeholders have had under the PQRS and VM informal review processes. Under those processes, we provided reasons for our decisions about the requests for informal review we received. Under the MIPS targeted review process, we intend to continue to provide MIPS eligible clinicians or groups with our reasons for granting or denying a request for review, and we will make an effort to provide additional clarifications of our reasons, if needed.
Furthermore, we would like to note that for the MIPS, targeted review, data validation, and audits are separate and distinct processes. Request for targeted reviews are an optional process available to MIPS eligible clinicians and groups, and a request for targeted review has no bearing on the initiation of a data validation and audit request. Lastly, data validation and audit requests do not initiate targeted reviews.
Additionally, we will continue to review the consideration to publically post information regarding the number of reviews requested and number of reviews that are granted each year.
Several commenters proposed that the timeframe to request a targeted review should be based on when the MIPS eligible clinician or group receives performance feedback and MIPS payment adjustment factors from CMS, not 60 days from the close of the data submission period. Another commenter suggested that most MIPS eligible clinicians or groups would prefer to request targeted reviews after performance feedback is released or at the beginning of a MIPS payment adjustment year. The commenter further suggested that CMS develop a timeline for targeted review that anticipates the
A few commenters noted that the 60-day deadline to submit a targeted review request may be inadequate, because MIPS eligible clinicians or groups may not have the data necessary to determine whether a targeted review is needed until performance feedback is received and analyzed. One commenter requested that MIPS eligible clinicians or groups get as much time as needed to submit to the targeted review process.
Several commenters had concerns about the targeted review process timeline and urged CMS to allow for review requests on rolling basis from data submission deadline until a minimum 90 days after performance feedback and MIPS payment adjustment information is provided. Another commenter believed that CMS should allow MIPS eligible clinicians or groups at least 45 days to review its reports before requesting a targeted review. In addition, the commenter stated that CMS should allow test submissions in order for MIPS eligible clinicians or groups and third party intermediaries to identify any issues prior to final submission.
In regards to the request to allow for “test submissions,” as noted in section II.E.9. of this final rule with comment period, we intend to provide testing tools prior to the beginning of the submission process to reduce any data errors associated with data submissions.
After consideration of the comments, we are finalizing policies as proposed, except for changes specifically discussed to reflect the modified policy for the submission deadline to request a targeted review from July 31 to September 30 of the year prior to the MIPS payment year or a later date specified by CMS, as well as the change for the timeframe whereby MIPS eligible clinician or group may submit additional information to assist in their targeted review at the time of request from 10 days to 30 days.
Specifically, we are finalizing at § 414.1385(a) that MIPS eligible clinicians or groups may request a targeted review of the calculation of the MIPS payment adjustment factor under section 1848(q)(6)(A) of the Act and, as applicable, the calculation of the additional MIPS payment adjustment factor under section 1848(q)(6)(C) of the Act applicable to such MIPS eligible clinician or group for a year. The process for targeted reviews is:
(1) MIPS eligible clinicians and groups have a 60-day period to submit a request for targeted review, which begins on the day CMS makes available the MIPS payment adjustment factor, and if applicable the additional MIPS payment adjustment factor, for the MIPS payment year and ends on September 30 of the year prior to the MIPS payment year or a later date specified by CMS.
(2) CMS will respond to each request for targeted review timely submitted and determine whether a targeted review is warranted.
(3) The MIPS eligible clinician or group may include additional information in support of their request for targeted review at the time the request is submitted. If CMS requests additional information from the MIPS eligible clinician or group, it must be provided and received by CMS within 30 days of the request. Non-responsiveness to the request for additional information may result in the closure of the targeted review request, although the MIPS eligible clinician or group may submit another request for targeted review before the deadline.
(4) Decisions based on the targeted review are final, and there is no further review or appeal.
Section 1848(q)(13)(B) of the Act, as added by section 101(c)(1) of the MACRA, provides there shall be no administrative or judicial review under sections 1869 and 1878 of the Act, or otherwise of the following:
• The methodology used to determine the amount of the MIPS payment adjustment factor and the amount of the additional MIPS payment adjustment factor and the determination of such amounts;
• The establishment of the performance standards and the performance period;
• The identification of measures and activities specified for a MIPS performance category and information made public or posted on the Physician Compare Internet Web site of the CMS; and
• The methodology developed that is used to calculate performance scores and the calculation of such scores, including the weighting of measures and activities under such methodology.
We proposed at § 414.1385 to implement these provisions as written in the statute.
We would reject any requests for targeted review under section 1848(q)(13)(A) of the Act that focus on the areas precluded from review under section 1848(q)(13)(B) of the Act. We requested but did not receive any comments on this proposal.
Therefore, we are finalizing § 414.1385 as proposed.
Our experience with the PQRS, VM and Medicare EHR Incentive Programs, has demonstrated the value of data validation and auditing as an important part of program integrity, which is necessary to ensure valid, reliable data. The current voluntary data validation process for PQRS and the audit process for the Medicare EHR Incentive Program are multi-step processes. We communicate the types of data elements that may be included for data validation across multiple Web sites and our documents. This includes defining specific data that may be abstracted from the CEHRT, as well as other documented records.
As we begin the MIPS, our strategy is to combine our past program integrity processes of the data validation process used in PQRS, and the auditing process used in the Medicare EHR Incentive Program into one set of requirements for MIPS eligible clinicians and groups, which we refer to as “data validation and auditing.” Based on our need for valid and reliable data on which to base a MIPS eligible clinician's or group's payment, we proposed certain requirements for MIPS eligible clinicians and groups submitting data for the 2017 performance period (see section II.E.4. of the proposed rule) under MIPS. Further, we proposed at § 414.1390 to selectively audit MIPS eligible clinicians on a yearly basis, and that if a MIPS eligible clinician or group is selected for audit, the MIPS eligible clinician or group would be required to do the following in accordance with applicable law:
• Comply with data sharing requests, providing all data as requested by us or our designated entity. All data must be shared with us or our designated entity within 10 business days or an alternate timeframe that is agreed to by us and the MIPS eligible clinician or group. Data would be submitted via email, facsimile, or an electronic method via a secure Web site maintained by us.
• Provide substantive, primary source documents as requested. These documents may include: Copies of claims, medical records for applicable patients, or other resources used in the data calculations for MIPS measures, objectives and activities. Primary source documentation also may include verification of records for Medicare and non-Medicare beneficiaries where applicable.
We proposed that we would monitor MIPS eligible clinicians and groups on an ongoing basis for data validation, auditing, program integrity issues and instances of non-compliance with MIPS requirements. If a MIPS eligible clinician or group is found to have submitted inaccurate data for MIPS, we proposed that we would reopen, revise, and recoup any resulting overpayments in accordance with the rules set forth at §§ 405.980 (re-opening rules), 450.982 and 450.984 (revising rules); and 405.370 and 405.373 (recoupment rules). It is important to note that at § 405.980(b)(3) there is an exception whereby we have the authority to re-open at any time for fraud or similar fault. If we re-open the initial determination we must revise it, and send out a notice of the revised determination under § 450.982. We also proposed that we would recoup any payments from the MIPS eligible clinician by the amount of any debts owed to us by the MIPS eligible clinician and likewise, we would recoup any payments from the group by the amount of any debts owed to us by the group. We also note that we would need to limit each such data validation and audit request to the minimum data necessary to conduct validation.
We proposed all MIPS eligible clinicians and groups that submit data to us electronically must attest to the accuracy and completeness to the best of their knowledge of any data submitted to us. This attestation would occur prior to any electronic data submissions, via a Web site maintained by us.
We requested comments on these proposals, and the following is a summary of the comments we received.
One commenter expressed concern that audit documentation requirements are not specified in the proposed rule because commenter believed such requirements in the past were not published until after the beginning of the performance year.
After consideration of the comments, we are finalizing the data validation policies as revised in this final rule with comment period. Specifically, we are finalizing § 414.1390 as proposed to selectively audit MIPS eligible clinicians and groups on a yearly basis, and that if a MIPS eligible clinician or group is selected for audit, the MIPS eligible clinician or group will be required to do the following in accordance with applicable law and timelines CMS establishes:
• Comply with data sharing requests, providing all data as requested by CMS or our designated entity. All data must be shared with CMS or our designated entity within 45 days of the data sharing request, or an alternate timeframe that is agreed to by CMS and the MIPS eligible clinician or group. Data will be submitted via email, facsimile, or an electronic method via a secure Web site maintained by CMS.
• Provide substantive, primary source documents as requested. These documents may include: copies of claims, medical records for applicable patients, or other resources used in the data calculations for MIPS measures, objectives and activities. Primary source documentation also may include verification of records for Medicare and non-Medicare beneficiaries where applicable.
We are also finalizing that we will perform ongoing monitoring of MIPS eligible clinicians and groups on an ongoing basis for data validation, auditing, program integrity issues and instances of non-compliance with MIPS requirements. If a MIPS eligible clinician or group is found to have submitted inaccurate data for MIPS, we are finalizing that we would reopen and revise the determination in accordance with the rules set forth at §§ 405.980 (re-opening rules), 450.982 and 450.984 (revising rules); and we would collect any overpayment in accordance with §§ 405.370 and 405.373 (recoupment rules). It is important to note that at § 405.980(b)(3) there is an exception whereby we have the authority to re-open at any time for fraud or similar fault. If we re-open the initial determination we must revise it, and send out a notice of the revised determination under § 450.982. We also are finalizing our approach to recoup improper payments from the MIPS eligible clinician by the amount of any debts owed to us by the MIPS eligible clinician and likewise, we would recoup any payments from the group by the amount of any debts owed to us by the group. We also note that we would limit each data validation and audit request to the minimum data necessary to conduct validation. Based on comments received, we intend to use data validation and audits as an educational opportunity for MIPS eligible clinicians and groups; therefore, during the transition year, the data validation and audit process will include education and support for MIPS eligible clinicians and groups selected for an audit.
Lastly, we are finalizing that all MIPS eligible clinicians and groups that submit data to us electronically must attest to the best of their knowledge that the data submitted to us is accurate and complete.
One of our strategic goals in developing MIPS includes developing a program that is meaningful, understandable, and flexible for participating MIPS eligible clinicians. One way we believe this will be accomplished is through flexible reporting options to accommodate different practices and make measurement meaningful. We believe this goal can be accomplished by allowing MIPS eligible clinicians the flexibility of using third party intermediaries to collect or submit data on their behalf. In this section, we are specifying the criteria that must be met to be approved by CMS as a third party intermediary. For purposes of this section, the use of the term “third party” refers to a qualified registry, a QCDR, a health IT vendor that obtains data from a MIPS eligible clinician's CEHRT, or a CMS-approved survey vendor.
In the PQRS program, quality measures data may be collected or submitted by third party vendors on behalf of an individual EP or group by: (1) A registry; (2) a QCDR; or (3) an EHR vendor that obtains data from an EP's CEHRT; or (4) a CMS-approved survey vendor. We proposed at § 414.1400(a)(1) that MIPS data may be submitted by third party intermediaries on behalf of a MIPS eligible clinician or group by: (1) A qualified registry; (2) a QCDR; (3) a health IT vendor; or (4) a CMS-approved survey vendor. Furthermore, we proposed at § 414.1400(a)(3) that third party intermediaries must meet all the criteria designated by us as a condition of their qualification or approval to participate in MIPS as a third party intermediary. As proposed at § 414.1400(a)(3)(ii), all submitted data must be submitted in the form and manner specified by us.
The following is a summary of the comments we received regarding our proposed definition of third party data intermediaries.
After consideration of the comments, we are finalizing our policies as proposed. Specifically, we are finalizing at § 414.1400(a)(1) that MIPS data may be submitted by third party intermediaries on behalf of a MIPS eligible clinician or group by: (1) A qualified registry; (2) a QCDR; (3) a health IT vendor; or (4) a CMS-approved survey vendor. Additionally, we are finalizing at § 414.1400(a)(3) that third party intermediaries must meet all the criteria designated by CMS as a condition of their qualification or approval to participate in MIPS as a third party intermediary. Lastly, we are finalizing at § 414.1400(a)(3)(ii), all submitted data must be submitted in the form and manner specified by CMS.
Section 1848(q)(1)(E) of the Act requires the Secretary to encourage the use of QCDRs under section 1848(m)(3)(E) of the Act in carrying out MIPS. Section 1848(q)(5)(B)(ii)(I) of the Act requires the Secretary, under the final score methodology, to encourage MIPS eligible clinicians to report on applicable measures for the quality performance category through the use of certified EHR technology and QCDRs. Section 1848(q)(2)(B)(iii)(II) of the Act requires that the improvement activities subcategories specified by the Secretary include population management, such as monitoring health conditions of individuals to provide timely health care interventions or participation in a QCDR. Section 1848(q)(12)(A)(ii) of the Act requires the Secretary to encourage the provision of performance feedback through QCDRs.
Section 1848(m)(3)(E)(i) of the Act requires the Secretary to establish requirements for an entity to be considered a QCDR, which must include a requirement that the entity provide the Secretary with such information, at such times, and in such manner, as the Secretary determines necessary to carry out section 1848(m) of the Act. Section 1848(m)(3)(E)(iv) of the Act requires the Secretary to consult with interested parties in carrying out section 1848(m)(3)(E) of the Act.
Currently, the QCDR reporting mechanism provides a method to satisfy PQRS requirements based on satisfactory participation. We proposed that entities interested in becoming a QCDR for MIPS go through a qualification process. This includes the QCDR meeting the definition of a QCDR, self-nomination criteria, and the criteria of a QCDR, including the deadlines listed below. This qualification process allows us to ensure that the entity has the capability to successfully report MIPS eligible clinicians' data to us and allows for review and approval of the QCDR's proposed non-MIPS quality measures. We intend to compile and post a list of entities that we “qualify” to submit data to us as a QCDR for purposes of MIPS on a Web site maintained by us.
Section 1848(q)(1)(E) of the Act encourages the use of QCDRs in carrying out the MIPS. Although section 1848(q)(5)(B)(ii)(I) of the Act specifically requires the Secretary to encourage MIPS eligible clinicians to use QCDRs to report on applicable measures for the quality performance category and section 1848(q)(12)(A)(ii) of the Act requires the Secretary to encourage the provision of performance feedback through QCDRs, the statute does not specifically address usage of QCDRs for the other MIPS performance categories. Although we could limit the usage of QCDRs to assessing the quality performance category under MIPS and providing performance feedback, we believe it would be less burdensome for MIPS eligible clinicians if we expand the QCDRs capabilities. By allowing QCDRs to report on the quality, advancing care information, and improvement activities performance categories we would alleviate the need for individual MIPS eligible clinicians and groups to use a separate mechanism to report data for these performance categories. It is important to note that no data will need to be reported for the cost performance category since these measures are administrative claims-based. Therefore, we proposed at § 414.1400(a)(2) to expand QCDRs' capabilities by allowing QCDRs to submit data on measures, activities, or objectives for any of the following MIPS performance categories:
• Quality;
• Improvement activities; or
• Advancing care information, if the MIPS eligible clinician or group is using CEHRT.
We believe this approach would permit a single QCDR to report on the quality, advancing care information, and improvement activities performance category requirements for MIPS and should mitigate the risks, costs, and burden of MIPS eligible clinicians having to report multiple times to meet the requirements of MIPS.
We proposed to define a QCDR at § 414.1305 as a CMS-approved entity that has self-nominated and successfully completed a qualification process to determine whether the entity may collect medical or clinical data for the purpose of patient and disease tracking to foster improvement in the quality of care provided to patients. Examples of the types of entities that may qualify as QCDRs include, but are not limited to, regional collaboratives and specialty societies using a commercially available software platform, as appropriate.
The following is a summary of the comments we received regarding our proposals on the definition of a QCDR and the performance categories for which a QCDR is allowed to submit data on behalf of MIPS eligible clinicians.
After consideration of the comments received, we are finalizing the QCDR policies as proposed. Specifically, we are finalizing at § 414.1400(a)(2) to expand QCDRs' capabilities by allowing QCDRs to submit data on measures, activities, or objectives for any of the following MIPS performance categories:
• Quality;
• Improvement activities; or
• Advancing care information, if the MIPS eligible clinician or group is using CEHRT.
Additionally, we are finalizing to define a QCDR at § 414.1305 as a CMS-approved entity that has self-nominated and successfully completed a qualification process to determine whether the entity may collect medical or clinical data for the purpose of patient and disease tracking to foster improvement in the quality of care provided to patients. Examples of the types of entities that may qualify as QCDRs include, but are not limited to, regional collaboratives and specialty societies using a commercially available software platform, as appropriate.
We proposed at § 414.1400(c) the establishment of a QCDR entity is required as follows: for an entity to become qualified for a given performance period as a QCDR, the entity must be in existence as of January 1 of the performance period for which the entity seeks to become a QCDR (for example, January 1, 2017, to be eligible to participate for purposes of performance periods beginning in 2017). The QCDR must have at least 25 participants by January 1 of the performance period. These participants do not need to be using the QCDR to report MIPS data to us; rather, they need to be submitting data to the QCDR for quality improvement.
The following is a summary of the comments we received regarding the establishment of an entity seeking to qualify as a QCDR.
After consideration of the comments received on the establishment of an entity seeking to qualify as a QCDR we are finalizing the policies as proposed. Specifically, we are finalizing at § 414.1400(c) the establishment of a QCDR entity is required as follows: for an entity to become qualified for a given performance period as a QCDR, the entity must be in existence as of January 1 of the performance period for which the entity seeks to become a QCDR (for example, January 1, 2017, to be eligible to participate for purposes of performance periods beginning in 2017). The QCDR must have at least 25 participants by January 1 of the performance period. These participants do not need to be using the QCDR to report MIPS data to us; rather, they need to be submitting data to the QCDR for quality improvement.
For the 2017 performance period we proposed at § 414.1400(b) a self-nomination period from November 15, 2016 until January 15, 2017. For future years of the program, starting with the 2018 performance period, we proposed to establish the self-nomination period from September 1 of the prior year until November 1 of the prior year. Entities that desire to qualify as a QCDR for the purposes of MIPS for a given performance period would need to self-nominate for that year and provide all information requested by us at the time of self-nomination. Having qualified as a QCDR in a prior year does not automatically qualify the entity to participate in MIPS as a QCDR in subsequent performance periods. For example, a QCDR may choose not to continue participation in the program in future years, or the QCDR may be precluded from participation in a future year due to multiple data or submission errors as noted below. Finally, QCDRs may want to update or change the measures or services or performance categories they intend to provide. As such, we believe an annual self-nomination process is the best process to ensure accurate information is conveyed to MIPS eligible clinicians and accurate data is submitted to MIPS.
We proposed to require other information (described below) of QCDRs at the time of self-nomination. If an entity becomes qualified as a QCDR, they will need to sign a statement confirming this information is correct prior to listing it on their Web site. Once we post the QCDR on our Web site, including the services offered by the QCDR, we will require the QCDR to support these services or measures for its clients as a condition of the entity's qualification as a QCDR for purposes of MIPS. Failure to do so will preclude the QCDR from participation in MIPS in the subsequent year.
The following is a summary of the comments we received regarding the self-nomination period.
After consideration of the comments received on the self-nomination period we are finalizing the policies as proposed. Specifically, for the 2017 performance period we are finalizing at § 414.1400(b) a self-nomination period from November 15, 2016 until January 15, 2017. For future years of the program, starting with the 2018 performance period, the self-nomination period must occur from September 1 of the prior year until November 1 of the prior year. Entities that desire to qualify as a QCDR for the purposes of MIPS for a given performance period would need to self-nominate for that year and
We are finalizing our proposal to require other information (described below) of QCDRs at the time of self-nomination. All self-nomination information must be submitted to
We proposed that a QCDR must provide the following information to us at the time of self-nomination to ensure that QCDR data is valid:
• Organization Name (Specify Sponsoring Organization name and software vendor name if the two are different. For example, a specialty society in collaboration with a software vendor).
• MIPS performance categories (that is, categories for which the entity is self-nominating. For example, quality, advancing care information, or improvement activities).
• Performance Period.
• Vendor Type (for example, qualified clinical data registry).
• Provide the method(s) by which the entity obtains data from its customers for each performance category for which it is approved: claims, web-based tool, practice management system, CEHRT, other (please explain). If a combination of methods (Claims, web-based tool, Practice Management System, CEHRT, or other) is utilized, the entity should state which method(s) it utilizes to collect data (for example, performance numerator and denominator).
• Indicate the method the entity will use to verify the accuracy of each TIN/NPI it is intending to submit (for example, National Plan and Provider Enumeration System (NPPES), CMS claims, tax documentation).
• Describe the method that the entity will use to accurately calculate performance rates for quality measures based on the appropriate measure type and specification. For composite measures or measures with multiple performance rates, the entity must provide us with the methodology the entity uses to calculate these composite measures and measures with multiple performance rates. The entity should be able to report to us a calculated composite measure rate if applicable.
• Describe the method that the entity will use to accurately calculate performance data for improvement activities and advancing care information based on the appropriate parameters or activities.
• Describe the process that the entity will use for completion of a randomized audit of a subset of data prior to the submission to us (for all performance categories the QCDR is submitting data on, that is, quality, improvement activities, and advancing care information, as applicable). Periodic examinations may be completed to compare patient record data with submitted data or ensure MIPS quality measures or other performance category (improvement activities, advancing care information) activities were accurately reported and performance calculated based on the appropriate measure specifications (that is, accuracy of numerator, denominator, and exclusion criteria) or performance category requirements.
• Provide information on the entity's process for data validation for both individual MIPS eligible clinicians and groups within a data validation plan. For example, for individuals it is encouraged that 3 percent of the TIN/NPIs submitted to us by the QCDR be sampled with a minimum sample of 10 TIN/NPIs or a maximum sample of 50 TIN/NPIs. For each TIN/NPI sampled, it is encouraged that 25 percent of the TIN/NPI's patients (with a minimum sample of five patients or a maximum sample of 50 patients) should be reviewed for all measures applicable to the patient.
• Provide the results of the executed data validation plan by May 31 of the year following the performance period. If the results indicate the QCDR's validation reveals inaccuracy or low compliance provide to CMS an improvement plan. Failure to implement improvements may result in the QCDR being placed in a probationary status or disqualification from future participation.
• For non-MIPS quality measures, if the measure is risk-adjusted, the QCDR is required to provide details to us on their risk adjustment methodology (risk adjustment variables, and applicable calculation formula) at the time of the QCDR's self-nomination. The QCDR must submit the risk adjusted results to us when submitting a risk-adjusted measure on behalf of the QCDR's MIPS eligible clinicians for the performance period.
The following is a summary of the comments we received regarding information required at the time of self-nomination for QCDRs.
After consideration of the comments received on the information required at the time of self-nomination for QCDRs we are finalizing the policies as proposed. Specifically, a QCDR must provide the information described above to us at the time of self-nomination to ensure that the QCDR data is valid.
In addition, we proposed that a QCDR must perform the following functions:
• For measures under the quality performance category and as proposed at § 414.1400(a)(4)(i), if the data is derived from CEHRT, the QCDR must be able to indicate this data source.
• QCDRs must provide complete quality measure specifications including data elements to us for non-MIPS quality measures intended for reporting from CEHRT.
• QCDRs must provide a plan to risk adjust (if appropriate for the measure) the non-MIPS quality measures data for which it collects and intends to transmit to us and must submit the risk-adjusted results (not the non-risk adjusted rates), to CMS. The risk adjustment methodology (formula and variables) must be integrated with the complete quality measure specifications. Specifically, for risk-adjusted non-MIPS quality measures, a QCDR is required to provide details to us on their risk adjustment methodology. The data elements used for risk adjustment may vary by measure and measure type. The risk adjustment methodology, including the risk adjustment variables, must be posted along with the measure's specifications on the QCDR's Web site. We believe risk-adjustment for certain outcomes measures is important to account for the differences in the complexities of care provided to different patients. That is, some patients may have additional comorbidities which could affect their response to treatment and subsequently their outcome. Risk adjustment will help offset potential poorer outcomes for those MIPS eligible clinicians caring for sicker patients.
• QCDRs submitting MIPS quality measures that are risk-adjusted (and have the risk-adjusted variables and methodology listed in the measure specifications) must submit the risk-adjusted measure results to CMS when submitting the data for these measures.
• Submit quality, advancing care information, or improvement activities data and results to us in the applicable MIPS performance categories for which the QCDR is providing data.
• A QCDR must have in place mechanisms for the transparency of data elements and specifications, risk models, and measures. That is, we expect that the non-MIPS measures and their data elements (that is, specifications) comprising these measures be listed on the QCDR's Web site unless the measure is a MIPS measure, in which case the specifications will be posted by us.
• Submit to us data on measures, activities, and objectives for all patients, not just Medicare patients.
• Provide timely feedback, at least 6 times a year, on all of the MIPS performance categories that the QCDR will report to us. That is, if the QCDR will be reporting on data for the improvement activities, advancing care information, or quality performance category, all results as of the performance feedback date should be included in the information sent back to the MIPS eligible clinician. The feedback should be given to the individual MIPS eligible clinician or group (if participating as a group) at the individual participant level or group level, as applicable, for which the QCDR reports. The QCDR is only required to provide feedback based on the MIPS eligible clinician's data that is available at the time the performance feedback is generated.
• Possess benchmarking capability (for non-MIPS quality measures) that
• QCDRs must comply with any request by us to review the data submitted by the QCDR for purposes of MIPS in accordance with applicable law. Specifically, data requested would be limited to the minimum necessary for us to carry out, for example, health care operations or health oversight activities.
• Mandatory participation in ongoing support conference calls hosted by us (approximately one call per month), including an in-person QCDR kick-off meeting (if held) at our headquarters in Baltimore, MD. More than one unexcused absence could result in the QCDR being precluded from participation in the program for that year. If a QCDR is precluded from participation in MIPS, the individual MIPS eligible clinician or group would need to find another QCDR or utilize another data submission mechanism to submit their MIPS data.
• Agree that data inaccuracies including (but not limited to) TIN/NPI mismatches, formatting issues, calculation errors, data audit discrepancies affecting in excess of 3 percent of the total number of MIPS eligible clinicians submitted by the QCDR may result in notations on our qualified QCDR posting of low data quality and would place the QCDR on probation (if they decide to self-nominate for the next program year). If the QCDR does not reduce their data error rate below 3 percent in the subsequent year, they would continue to be on probation and have their listing on the CMS Web site continue to note the poor quality of the data they are submitting for MIPS. Data errors affecting in excess of 5 percent of the MIPS eligible clinicians submitted by the QCDR may lead to the disqualification of the QCDR from participation in the following year's program. As we gain additional experience with QCDRs, we intend to revisit and enhance these thresholds in future years.
• Be able to submit results for at least six quality measures including one cross-cutting measure and one outcome measure. If an outcome measure is not available, be able to submit results for at least one other high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures). If no outcome measure is available, then the QCDR must provide a justification for not including an outcome measure.
• QCDRs may request to report on up to 30 quality measures not in the annual list of MIPS quality measures. Full specifications will need to be provided to us at the time of self-nomination. We will review the quality measures and determine if they are appropriate for QCDR reporting.
• Enter into and maintain with its participating MIPS eligible clinicians an appropriate Business Associate agreement that provides for the QCDR's receipt of patient-specific data from an individual MIPS eligible clinician or group, as well as the QCDR's disclosure of quality measure results and numerator and denominator data or patient specific data on Medicare and non-Medicare beneficiaries on behalf of MIPS eligible clinicians and groups.
• Obtain and keep on file signed documentation that each holder of an NPI whose data are submitted to the QCDR, has authorized the QCDR to submit quality measure results, improvement activities measure and activity results, advancing care information objective results and numerator and denominator data or patient-specific data on Medicare and non-Medicare beneficiaries to CMS for the purpose of MIPS participation. This documentation should be obtained at the time the MIPS eligible clinician or group signs up with the QCDR to submit MIPS data to the QCDR and must meet the requirements of any applicable laws, regulations, and contractual business associate agreements. Groups participating in MIPS via a QCDR may have their group's duly authorized representative grant permission to the QCDR to submit their data to us. If submitting as a group, each individual MIPS eligible clinician does not need to grant their individual permission to the QCDR to submit their data to us.
• Not be owned and managed by an individual locally owned single specialty group (for example, single specialty practices with only one practice location or solo practitioner practices are prohibited from self-nominating to become a qualified QCDR).
• Be able to separate out and report on all payers including Medicare Part B FFS patients and non-Medicare patients.
• Provide the measure numbers for the MIPS quality measures on which the QCDR is reporting.
• Provide the measure title for the MIPS quality measures and improvement activities (if applicable) on which the QCDR is reporting.
• Report the number of eligible instances (reporting denominator).
• Report the number of instances a quality service is performed (performance numerator).
• Report the number of performance exclusions, meaning the quality action was not performed for a valid reason as defined by the measure specification.
• Comply with a CMS-specified secure method for data submission, such as submitting the QCDR's data in an XML file.
• Sign a document verifying the QCDR's name, contact information, cost for MIPS eligible clinicians or groups to use the QCDR, services provided, and the measures and specialty-specific measure sets the QCDR intends to report. Once posted, on the QCDR's or CMS Web site, the QCDR will need to support the measures or measure sets confirmed by the QCDR. Failure to do so will preclude the QCDR from participation in MIPS in the subsequent year.
• Must provide attestation statements during the data submission period that all of the data (quality measures, improvement activities, and advancing care information measures and objectives, if applicable) and results are accurate and complete.
• For purposes of distributing performance feedback to MIPS eligible clinicians, collect a MIPS eligible clinician's email addresses and have documentation from the MIPS eligible clinician authorizing the release of his or her email address.
• Be able to calculate and submit measure-level reporting rates or, upon request, the data elements needed to calculate the reporting and performance rates by TIN/NPI and/or TIN.
• Be able to calculate and submit, by TIN/NPI and/or TIN, a performance rate (that is the percentage of a defined population who receive a particular process of care or achieves a particular outcome based on a calculation of the measures' numerator and denominator specifications) for each measure on which the TIN/NPI or TIN reports or, upon request the Medicare beneficiary data elements needed to calculate the performance rates.
• Provide the performance period start date the QCDR will cover.
• Provide the performance period end date the QCDR will cover.
• Report the number of reported instances, performance not met, meaning the quality actions was not performed for no valid reason as defined by the measure specification.
• For data validation purposes, provide information on the entity's sampling methodology. For example, it is encouraged that 3 percent of the MIPS eligible clinicians be sampled with a minimum sample of 10 MIPS eligible clinicians or a maximum sample of 50 MIPS eligible clinicians. For each MIPS eligible clinicians sampled, it is encouraged that 25 percent of the MIPS eligible clinicians' patients (with a minimum sample of five patients or a maximum sample of 50 patients) should be reviewed for all measures applicable to the patient.
• Submit all of the measures (MIPS measures and non-MIPS measures) including specifications for the non-MIPS measures to us on a designated Web page. The measures must address a gap in care. Outcome or other high priority types of measures are preferred. Simple documentation or “check box” measures are discouraged.
The following is a summary of the comments we received regarding QCDR criteria for data submission.
Under the regulations at § 401.722, QCDRs are allowed to serve as quasi qualified entities, provided the QCDR agrees to meet all the requirements of the program with the exception of the requirement at § 401.707(d) that the organization submit information about the claims data it possesses from other sources. In addition, for the purposes of QCDRs serving as quasi qualified entities, we defined combined data as, at a minimum, CMS claims data combined with clinical data or a subset of clinical data. We believe that the requirements of the qualified entity program create an appropriate framework for QCDRs to conduct analyses to support quality improvement and patient safety and to work directly with providers and suppliers on issues related to quality improvement and patient safety.
With regard to the SSDMF, we recognize that death information is a key aspect of analyses of patient outcomes, but we do not have the authority to disclose the SSDMF to QCDRs. However, we have the date of death information for Medicare patients and we include this date of death information on the data files that are shared with qualified entities and those that are shared with QCDRs who are approved as quasi qualified entities.
After consideration of the comments received on the QCDR criteria for data submission we are finalizing our policies as proposed, with the following exceptions: Specifically, we have decided to alter the requirement to provide timely feedback to MIPS eligible clinicians six times a year. Rather based on feedback from stakeholders we will finalize the requirement as follows: Provide timely feedback, at least four times a year, on all of the MIPS performance categories that the QCDR will report to us. That is, if the QCDR will be reporting on data for the improvement activities, advancing care information, or quality performance category, all results as of the performance feedback date should be included in the information sent back to the MIPS eligible clinician. The feedback should be given to the individual MIPS eligible clinician or group (if participating as a group) at the individual participant level or group level, as applicable, for which the QCDR reports. The QCDR is only required to provide feedback based on the MIPS eligible clinician's data that is available at the time the performance feedback is generated.
Additionally, based on our policies finalized in section II.E.5.b.(3) of this final rule with comment period, we are not requiring MIPS eligible clinicians to submit data on cross-cutting measures. Therefore, we are finalizing the requirement at § 414.1335(a)(1)(i) for QCDRs as follows: Be able to submit results for at least six quality measures including one outcome measure. If an outcome measure is not available, be able to submit results for at least one other high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures). If no outcome measure is available, then the QCDR must provide a justification for not including an outcome measure.
A QCDR must provide specifications for each measure, activity, or objective the QCDR intends to submit to CMS. We proposed at § 414.1400(f) the QCDR must provide the following information:
• Provide descriptions and narrative specifications for each measure activity, or objective for which it will submit to us by no later than January 15 of the applicable performance period for which the QCDR wishes to submit quality measures or other performance category (improvement activities and advancing care information) data. In future years, starting with the 2018 performance period, those specifications must be provided to us by no later than November 1 prior to the applicable performance period for which the QCDR wishes to submit quality measures or other performance category (improvement activities and advancing care information) data.
• For non-MIPS quality measures, the quality measure specifications must include: name or title of measures, NQF number (if NQF-endorsed), descriptions of the denominator, numerator, and when applicable, denominator exceptions, denominator exclusions, risk adjustment variables, and risk adjustment algorithms. The narrative
• For MIPS measures, the QCDR only needs to submit the MIPS measure numbers and the specialty-specific measure sets (if applicable).
• The QCDR must publicly post the measure specifications (no later than 15 days following our approval of these measure specifications) for each non-MIPS quality measure it intends to submit for MIPS. The QCDR may use any public format it prefers. Immediately following posting of the measures specification information, the QCDR must provide us with the link to where this information is posted. We would then post this information when it provides its list of QCDRs for the year.
The following is a summary of the comments we received regarding QCDR measure specifications criteria.
After consideration of the comments regarding the proposal on the QCDR measure specifications criteria we are finalizing the policies as proposed at § 414.1400(f).
To explain the definition of a non-MIPS quality measures for purposes of QCDRs submitting data for the MIPS quality performance category, we proposed at § 414.1400(e) to consider the following types of quality measures to be non-MIPS quality measures:
• A measure that is not contained in the annual list of MIPS quality measures for the applicable performance period.
• A measure that may be in the annual list of MIPS quality measures but has substantive differences in the manner it is submitted by the QCDR. For example, if a MIPS quality measure is only reportable via the CMS Web Interface and a QCDR wishes to report this quality measure on behalf of its MIPS eligible clinicians, the quality measure would be considered a non-MIPS quality measure. This is because we would have only extracted the data collected from this quality measure using the CMS Web Interface, in which we utilize a claims-based assignment and sampling methodology to inform the groups on which patients they are to report, and the reporting of this quality measure would require changes to the way that the quality measure is calculated and reported to us via a QCDR instead of through the CMS Web Interface. Therefore, due to the substantive changes needed to report this quality measure via a QCDR, this CMS Web Interface quality measure would be considered a non-MIPS quality measure. CMS would not be able to directly compare MIPS eligible clinicians submitting the quality measure using the CMS Web Interface to those submitting the quality measure using the QCDR. Thus, this would be considered a non-MIPS quality measure.
• In addition, the CAHPS for MIPS survey currently could be submitted only using a CMS-approved survey vendor. Although the CAHPS for MIPS survey is proposed for inclusion in the MIPS measure set, we consider the changes that will need to be made available for reporting by individual MIPS eligible clinicians (and not as a part of a group) significant enough as to treat the CAHPS for MIPS survey as a non-MIPS quality measure for purposes of reporting the CAHPS for MIPS survey via a QCDR. To the extent that further clarification on the distinction between a MIPS and a non-MIPS measure is necessary, we will provide additional guidance on our Web site.
The following is a summary of the comments we received regarding identifying non-MIPS quality measures.
The MIPS measures for which eCQM specifications are available can be readily identified by presence of a CMS e-Measure ID and by inclusion of “EHR” in the “Data Submission Method” column for that measure in the Appendix Table A: Individual Quality Measure Available for MIPS Reporting in 2017 of this final rule with comment period. Specifications and additional information relevant to submitting eCQMs to CMS are available at
A QCDR that is submitting non-MIPS measures is not required to use HQMF or QRDA, and may choose to use an API or other relevant standards supported by its participants' health IT to achieve standards-based access to quality measurement data. Because the HQMF and QRDA standards are familiar to many health IT vendors and EHR vendors, a registry might choose to use one or both of these standards to implement non-MIPS measures. In this case, we would encourage the registry to use the development and testing tools available via the CMS-ONC eCQI Resource Center Web site (
After consideration of the comments regarding the proposal regarding identifying non-MIPS quality measures we are finalizing the policies as proposed at § 414.1400(e).
In the CY 2016 PFS final rule (80 FR 71136 through 71138) we finalized our proposal to allow collaboration of entities to become a QCDR based on our experience with the qualifying entities wishing to become QCDRs for performance periods. We received feedback from organizations who expressed concern that the entity wishing to become a QCDR may not meet the criteria of a QCDR solely on its own. We believe this policy supporting entity collaboration should be continued under MIPS. Therefore, we proposed at § 414.1400 that an entity that may not meet the criteria of a QCDR solely on its own but could do so in conjunction with another entity, would be eligible for qualification through collaboration with another entity.
We proposed to allow that an entity that uses an external organization for purposes of data collection, calculation, or transmission may meet the definition of a QCDR provided the entity has a signed, written agreement that specifically details the relationship and responsibilities of the entity with the external organization effective as of September 1 the year prior to the year for which the entity seeks to become a QCDR (for example, September 1, 2016, to be eligible to participate for purposes of the 2017 performance period). Entities that have a mere verbal, non-written agreement to work together to become a QCDR by September 1 the year prior to the year for which the entity seeks to become a QCDR would not fulfill this proposed requirement. We requested comments on these proposals.
The following is a summary of the comments we received regarding collaboration of entities to become a QCDR.
After consideration of the comments received on the collaboration of entities to become a QCDR we are finalizing the policies as proposed. Specifically, we are finalizing at § 414.1400 that an entity that may not meet the criteria of a QCDR solely on its own but could do so in conjunction with another entity, would be eligible for qualification through collaboration with another entity.
Currently, clinicians seeking to meet CMS quality program technology requirements must use EHR technology that is certified and meets the CEHRT definition established under the EHR Incentive Programs at 42 CFR 495.4. The Office of the National Coordinator for Health Information Technology (ONC) health IT certification program has established standards and other criteria for structured data that EHRs must use in order to be successfully tested and certified. We proposed to maintain this standard and require EHR-based data submission (whether transmitted directly from the EHR or from a data intermediary) to be CEHRT to submit quality measures, advancing care information, and improvement activities data for MIPS. In addition, we proposed at § 414.1400(a)(4) that health IT vendors that obtain data from a MIPS eligible clinician's CEHRT, like other third party intermediaries, would have to meet all criteria designated by us as a condition of their qualification or approval to participate in MIPS as a third party intermediary. This includes submitting data in the form and manner specified by us as proposed at § 414.1400(a)(4)(ii). We anticipate that for the initial years of MIPS the form and manner requirements would be similar to what was used in the PQRS program. However, at a minimum these will be modified to address the four performance categories under MIPS and MIPS data calculation needs. As we gain experience under MIPS we anticipate that these form and manner requirements may change in future years to ease reporting burden. Historical form and manner requirements under the PQRS program are available at
Although section 1848(q)(5)(B)(ii)(I) of the Act specifically requires the Secretary to encourage MIPS eligible clinicians to report on applicable measures using EHR technology with respect to the quality performance category, the statute does not specifically address allowing a third party intermediary—such as a health IT vendor—to submit on a MIPS eligible clinician's behalf for the other performance categories. Although we could limit the usage of health IT vendors assessing the quality performance category under MIPS, we believe it would be less burdensome for MIPS eligible clinicians if we expand the health IT vendors' capabilities. By allowing health IT vendors to report on the quality, advancing care information, and improvement activities performance categories we would alleviate the need for individual MIPS eligible clinicians and groups to use a separate mechanism to report data for these performance categories. Our intention is to encourage health IT vendors to design systems that are able to support new types of EHR reporting (for example, improvement activities and advancing care information) from MIPS eligible clinicians and groups—this would be in addition to the quality measure data that we already can accept. Therefore, we proposed at § 414.1400(a)(2) to expand health IT vendors' capabilities by allowing health IT vendors to submit data on measures, activities, or objectives for any of the following MIPS performance categories:
• Quality;
• Improvement activities; or
• Advancing care information.
As proposed at § 414.1400(a)(1), health IT vendors submitting data on behalf of a MIPS eligible clinician or group would be required to obtain data from the MIPS eligible clinician's CEHRT. We believe this approach would permit a single health IT vendor to report on quality, advancing care information, and improvement activities performance category requirements for MIPS on behalf of multiple eligible clinicians or groups and should mitigate the risks, costs, and burden of MIPS eligible clinicians having to report multiple times to meet the requirements of MIPS.
We further proposed that health IT vendors must be able to do the following:
• For measures, activities, and objectives under the quality, advancing care information, and improvement activities performance categories, and as proposed at § 414.1400(a)(4)(i); if the data is derived from CEHRT, the health IT vendor must be able to indicate this data source.
• Either transmit data from the certified EHR technology or through a data intermediary in the CMS-specified form and manner, or have the ability for the individual MIPS eligible clinician and group to be able to submit data directly from their CEHRT, in the CMS-specified form and manner.
For MIPS eligible clinicians who choose to electronically submit quality, advancing care information, and improvement activities data extracted from their CEHRT to an intermediary, the intermediary would then submit the measure and activity data to us in a CMS-specified form and manner on the MIPS eligible clinician's behalf for the respective performance period. In addition to meeting the appropriate data submission criteria for the quality, advancing care information, and improvement activities performance categories for the MIPS EHR submission mechanism, MIPS eligible clinicians who choose the EHR submission mechanism would be required to have CEHRT meeting the proposed definition at § 414.1305. We requested comments on these proposals.
The following is a summary of the comments we received regarding health IT vendors and other third parties that obtain data from an eligible clinician's CEHRT, referred to throughout this section as “health IT vendors.”
We established the definition of CEHRT to set the federal specifications for clinicians using certified health IT within our programs. For a certified health IT product or products to meet the CEHRT definition they must include Health IT Modules which are certified to certification criteria under the ONC Health IT Certification Program and are related to certain CMS program reporting. These include the ability to calculate the advancing care information measures, as well as the ability to accurately capture and export
We note that form and manner requirements for the submission are related to the requirements defined for the measures and activities in each performance category within this final rule with comment period. Therefore, we note that while there is no specific standard or certification requirement for a health IT vendor or other authorized third party submitting data on behalf of an eligible clinician or group beyond the form and manner specifications for the submission mechanism, the eligible clinician or group must still meet the category or measure specific requirements. For example, within the quality performance category there are different requirements for CQMs which must be met depending on the measures an MIPS eligible clinician or group chooses to report, and the form and manner must be used for the submission mechanism appropriate for reporting those selected measures. This is consistent with prior CMS policy for PQRS and the EHR Incentive Programs, and is reflected in the CEHRT definition for the quality payment programs at § 414.1305 for MIPS eligible clinicians or groups supported by these services. For example, the CQM submission requirement within that CEHRT definition states at paragraph (1)(ii)(B)(
We appreciate the commenter's concern however on health IT vendors becoming a QCDR without the sponsorship or governance of a professional organization and would like to refer the commenter above to section II.E.9.a.(7) of this final rule with comment period, where we discuss the requirements of allowable partnerships between IT vendors and specialty organizations. We further disagree with setting no requirements for any third party intermediary as these policies ensure both that the MIPS eligible clinician is provided appropriate supports and protections and that CMS is able to accept and use the data submitted on their behalf.
Some commenters agreed with the health IT vendor criteria at § 414.1400(a)(2). However, the commenters were concerned about the ability of health IT vendors to incorporate mechanisms for reporting the new advancing care information and improvement activities performance
However, we do agree with the commenters who note that the inclusion of improvement activities performance category reporting should be allowed for health IT vendors and we intend to allow MIPS eligible clinicians and groups the option to submit improvement activities performance category data in a manner similar to current reporting. In this way, we maintain our intent to encourage health IT vendors to design systems to be able to accept and support new types of data reporting within EHR systems. We further note that for MIPS, we are maintaining the requirement that submissions be reported in the form and manner specified by CMS. That form and manner will be specified by CMS for each available submission method through subregulatory guidance consistent with prior CMS quality reporting programs.
We appreciate the commenter's feedback regarding the use of the QRDA and note than in prior years the CMS Implementation Guide (IG) included updated specifications for the QRDA that are similar to the types of updates that could potentially be included for reporting on advancing care information and improvement activities performance categories in MIPS. We do, however, understand and acknowledge the commenters concern on the timing of development to the IG as well as the need for adequate time for development, testing, and verification of any future updates to the QRDA Implementation Guide. We note that we will provide additional details related to the Quality Payment Program data submission standard at
We note that it is not our intent to move away from the use of certified health IT for calculating measures, but rather our intent is to recognize and accommodate the variability among MIPS eligible clinicians in technology use and adoption. Through these policies, we are seeking to reduce the burden and remove entry barriers to participation where possible for those MIPS eligible clinicians who may be engaging with CEHRT, meaningful use, quality measurement, and improvement activities for the first time as an individual MIPS eligible clinician or group. By allowing for greater flexibility in the first few years of the program, we are establishing a guide path to move toward expanded adoption, implementation, use, and innovation of certified health IT. In this way, we are allowing for adequate time for MIPS eligible clinicians, health IT vendors, and other third party entities like QCDRs to develop, test, implement, and monitor health IT systems designed to support participation in MIPS. However, where relevant standards have been established as part of the certification program, we believe that applying these standards will support more reliable, accurate quality measurement, and we will work with Quality Payment Program participants and the health IT vendor community to continue to expand the availability and applicability of these tools. Finally, we are maintaining our focus on electronic reporting that is standards-based. We also believe this approach encourages increased adoption and use within the health care industry of advanced health IT amongst MIPS eligible clinicians and APM entities. We intend to publish specific standards that third party intermediaries will need to follow for data submission through subregulatory guidance and will work with health IT vendors to develop, test, and verify that guidance for MIPS data submission.
Second, there are not separate CEHRT requirements for separate CMS programs which reference CEHRT. The ONC-established certification criteria which are included in the CEHRT definition for the Quality Payment Program at § 414.1305 and required for MIPS are not specific to a single component of CMS programs. Instead, ONC certifies individual Health IT Modules to perform specific functions using specific standards and implementation specifications that are part of the ONC Editions of certification criteria which are required only for those health IT vendors which are seeking to have their health IT certified. CMS then defines a package or collection of those certified Health IT Modules which an MIPS eligible clinician or group must possess to meet the CMS definition of CEHRT. The definition of CEHRT is currently substantively the same for MIPS, the EHR Incentive Programs, and Advanced Alternate Payment Models. This means that if an MIPS eligible clinician has an EHR system that meets the CEHRT definition, that system can support participation in each program (MIPS, EHR Incentive Program of AAPM) for which that clinician is eligible. The MIPS eligible clinician, or a health IT vendor submitting on their behalf, can report using data from that CEHRT for any such program without any additional certification as long as the submission meets the form and manner requirements established by CMS.
Finally, there are multiple data submission methods available to MIPS eligible clinicians and groups. These multiple paths for reporting are designed to allow for flexibility to select the method most relevant for their practice, processes, and available features. For each of these submission methods, any submission on behalf of an MIPS eligible clinician or group must meet the form and manner requirements for data submission to us for that method. We understand a third party may offer a wide range of services to an MIPS eligible clinician or group beyond data submission to us. However, if that third party is offering data submission services for MIPS eligible clinicians, they must meet the form and manner specifications related to the chosen submission method. It is essential to maintain form and manner requirements specific to each of those methods in order to ensure the data can be accurately received, validated, and used to establish the appropriate payment adjustment for the performance period. We believe the flexibility of multiple paths will help to minimize burden on MIPS eligible clinicians, groups, and authorized third party intermediaries submitting on their behalf.
After consideration of the comments regarding health IT vendors that obtain data from MIPS eligible clinician's CEHRT, we are finalizing that the MIPS eligible clinicians who choose the EHR submission mechanism would be required to have certified EHR technology meeting the CEHRT definition for the quality payment program at § 414.1305 as proposed. In addition, we are finalizing the proposed policies for submission with modifications as follows.
We are not finalizing a requirement for any certification criteria related to the submission of data beyond those which are currently defined within the CEHRT definition for the quality payment programs at § 414.1305.
In addition, we are further noting that the requirements within the CEHRT definition apply to the MIPS eligible clinician or group, not to the health IT vendor or other third party intermediary supporting that MIPS eligible clinician with data submission. We are finalizing at § 414.1325(b)(2) and (c)(2) to allow MIPS eligible clinicians and groups to submit data for the improvement activities performance category, and data exported or extracted from CEHRT for the quality and advancing care information performance categories, either directly to CMS or with the support of a third party intermediary such as a health IT vendor or other authorized third party.
Additionally, we are finalizing modifications to our proposal at § 414.1400(a)(1) and (a)(2) that a health IT vendor or other authorized third party intermediary may submit data for the improvement activities performance category, and data exported or extracted from CEHRT for the quality and advancing care information performance categories, on behalf of an MIPS eligible clinician or group.
We are finalizing at § 414.1400(a)(4) that health IT vendors and other authorized third party intermediaries that obtain data exported or extracted from a MIPS eligible clinician's CEHRT would have to meet all criteria designated by us as a condition of their qualification or approval to participate in MIPS as a third party intermediary. As noted, this would include authorization by the MIPS eligible clinician or group to submit on their behalf and also includes submitting data in the form and manner specified at § 414.1400(a)(4)(ii).
Finally, we are finalizing a modification to the proposed policy regarding the requirements for health IT vendors to state that health IT vendors or other authorized third party intermediary that are submitting on behalf of an MIPS eligible clinician or group must be able to do the following to submit MIPS data to us:
• For measures, activities, and objectives under the quality, advancing care information, and improvement activities performance categories, and as proposed at § 414.1400(a)(4)(i); if the data is exported or extracted from certified EHR technology, the health IT vendor or third party must be able to indicate this data source; and
• Transmit the data electronically exported or extracted from the CEHRT to us directly or through a data intermediary in the CMS-specified form and manner.
We proposed to define a qualified registry at § 414.1305 as a medical registry, a maintenance of certification program operated by a specialty body of the American Board of Medical Specialties or other data intermediary that, with respect to a particular performance period, has self-nominated and successfully completed a vetting process (as specified by CMS) to demonstrate its compliance with the MIPS qualification criteria specified by CMS for that performance period. The registry must have the requisite legal authority to submit MIPS data (as specified by CMS) on behalf of a MIPS eligible clinician or group to CMS. In addition, we proposed at § 414.1400(a)(2) to expand a qualified registry's capabilities by allowing qualified registries to submit data on measures, activities, or objectives for any of the following MIPS performance categories:
• Quality;
• Improvement Activities; or
• Advancing care information, if the MIPS eligible clinician or group is using certified EHR technology.
The following is a summary of the comments we received regarding the proposed qualified registry definition and expanded capabilities proposal.
After consideration of the comments on the qualified registry policies above we are finalizing the policies at §§ 414.1305 and 414.1400(a)(2) as proposed.
We proposed at § 414.1400(h) that in order for an entity to become qualified for a given performance period as a qualified registry, the entity must be in existence as of January 1 of the performance period for which the entity seeks to become a qualified registry (for example, January 1, 2017, to be eligible to participate for purposes of performance periods beginning in 2017). The qualified registry must have at least 25 participants by January 1 of the performance period. These participants do not necessarily need to be using the qualified registry to report MIPS data to us; rather, they need to be submitting data to the qualified registry for quality improvement. We also proposed a qualified registry must provide attestation statements from the qualified registry/MIPS eligible clinicians during the data submission period that all of the data (quality measures, improvement activities, and advancing care information measures and objectives, if applicable) and results are accurate and complete.
The following is a summary of the comments we received regarding our proposal for the establishment of an entity seeking to qualify as a registry.
After consideration of the comments received regarding our proposal for the establishment of an entity seeking to qualify as a registry, we are finalizing the policies at § 414.1400(h) as proposed.
For the 2017 performance period, we proposed at § 414.1400(g) a self-nomination period from November 15, 2016 until January 15, 2017. For future years of the program, starting with the 2018 performance period, we proposed to establish the self-nomination period from September 1 of the prior year until November 1 of the year in which the qualified registry seeks to be qualified. Entities that desire to qualify as a qualified registry for purposes of MIPS for a given performance period would need to provide all requested information to us at the time of self-nomination and would need to self-nominate for that performance period. Having qualified as a qualified registry does not automatically qualify the entity to participate in subsequent MIPS performance periods. For example, a qualified registry may choose not to continue participation in the program in future years, OR the qualified registry may be precluded from participation in a future year, due to multiple data or submission errors as noted below. As such, we believe an annual self-nomination process is the best process to ensure accurate information is conveyed to MIPS eligible clinicians and accurate data is submitted to MIPS.
We proposed to require further information of qualified registries at the time of self-nomination. All self-nomination information must be submitted to
We did not receive any comments regarding our proposals for the qualified registry self-nomination period. Therefore, we are finalizing the policies at § 414.1400(g) as proposed.
We proposed that a qualified registry must provide the following information to us at the time of self-nomination:
• Organization Name (Specify Sponsoring Organization name and software vendor name if the two are different. For example, a specialty society in collaboration with a software vendor).
• MIPS performance categories (that is, categories for which the entity is self-nominating to report. For example, quality measures, advancing care information, or improvement activities).
• Performance Period.
• Vendor Type (for example, qualified registry).
• Provide the method(s) by which the entity obtains data from its customers for each performance category for which it is approved: Claims; web-based tool; practice management system; CEHRT; other (please explain). If a combination of methods (Claims, web-based tool, Practice Management System, CEHRT, or other) is utilized, please state which method(s) the entity utilizes to collect data (performance numerator and denominator).
• Indicate the method the entity will use to verify the accuracy of each TIN/NPI and/or TIN it is intending to submit (for example; National Plan and Provider Enumeration System (NPPES), CMS claims, tax documentation).
• Describe the method the entity will use to accurately calculate performance rates for quality measures based on the appropriate measure type and specification. For composite measures or measures with multiple performance rates, the entity must provide us with the methodology the entity uses to calculate these composite measures and measures with multiple performance rates. The entity should be able to report to us a calculated composite measure rate, if applicable.
• Describe the method that the entity will use to accurately calculate performance data for improvement activities and advancing care information performance categories based on the appropriate parameters or activities.
• Describe the process that the entity will use for completion of a randomized audit of a subset of data prior to the submission to us (for all performance categories the qualified registry is submitting data on; that is, quality, improvement activities, and advancing care information, as applicable). Periodic examinations may be completed to compare patient record data with submitted data or ensure MIPS quality measures or other performance category (improvement activities and advancing care information) activities, measures, or objectives were accurately reported and performance calculated based on the appropriate measure specifications (that is, accuracy of numerator, denominator, and exclusion criteria) or performance category criteria.
• Provide information on the entity's process for data validation for both individual MIPS eligible clinicians and groups within a data validation plan. For example, for individuals, it is encouraged that 3 percent of the MIPS eligible clinicians submitted to CMS by the qualified registry be sampled with a minimum sample of 10 TIN/NPIs or a maximum sample of 50 MIPS eligible clinicians. For each MIPS eligible clinician sampled, it is encouraged that 25 percent of the MIPS eligible clinicians' patients (with a minimum sample of five patients or a maximum sample of 50 patients) should be reviewed for all measures applicable to the patient.
• Provide the results of the executed data validation plan by May 31st of the year following the performance period. If the results indicate the qualified registry's validation reveals inaccuracy or low compliance provide to us an improvement plan. Failure to implement improvements may result in the qualified registry being placed in a probationary status or disqualification from future participation.
We did not receive any comments on the proposal regarding information required at the time of self-nomination for a qualified registry. Therefore, we are finalizing the above policies as proposed.
Further, we proposed that a qualified registry must perform the following functions:
• For measures, activities, and objectives under the quality, advancing care information, and improvement activities performance categories and as proposed at § 414.1400(a)(4)(i); if the data is derived from CEHRT, the qualified registry must be able to indicate this data source.
• A qualified registry submitting MIPS quality measures that are risk-adjusted (and have the risk-adjusted variables and methodology listed in the measure specifications) must submit the risk-adjusted measure results to CMS when submitting the data for these measures.
• Submit to us, quality measures and activities data on all patients, not just Medicare patients.
• Submit quality measures, advancing care information, or improvement activities performance categories data and results to us in the applicable MIPS performance categories for which the qualified registry is providing data.
• Provide timely feedback, at least four times a year, on all of the MIPS performance categories that the qualified registry will report to us. That is, if the qualified registry will be reporting on data for the improvement activities, advancing care information, or quality performance category, all results as of the performance feedback date should be included in the information sent to the MIPS eligible clinician. The feedback should be given to the individual MIPS eligible clinician or group (if participating as a group) at the individual participant level or group level, as applicable, for which the qualified registry reports. The qualified registry is only required to provide feedback based on the MIPS eligible clinician's data that is available at the time the performance feedback is generated.
• A qualified registry must comply with any request by us to review the data submitted by the qualified registry for purposes of MIPS in accordance with applicable law. Specifically, data requested would be limited to the minimum necessary for us to carry out, for example, health care operations or health oversight activities.
• Mandatory participation in ongoing support conference calls hosted by us (approximately one call per month), including an in-person qualified registry kick-off meeting (if held) at our headquarters in Baltimore, MD. More than one unexcused absence could result in the qualified registry being precluded from participation in the program for that year. If a qualified registry is precluded from participation in MIPS, the individual MIPS eligible clinician or group would need to find another entity to submit their MIPS data.
• Agree that data inaccuracies including (but not limited to) TIN/NPI mismatches, formatting issues, calculation errors, data audit discrepancies affecting in excess of 3 percent of the total number of MIPS eligible clinicians submitted by the qualified registry may result in notations on our qualified registry posting of low data quality and would place the qualified registry on probation (if they decide to self-nominate for the next program year). If the qualified registry does not reduce their data error rate below 3 percent in the subsequent year, they would continue to be on probation and have their listing on the CMS Web site continue to note the poor quality of the data they are submitting for MIPS. Data errors affecting in excess of 5 percent of the MIPS eligible clinicians submitted by the qualified registry may lead to the disqualification of the qualified registry from participation in the following year's program. As we gain additional experience with qualified registries, we
• Be able to report at least six quality measures including one cross-cutting measure and one outcome measure. If an outcome measure is not available, be able to report another high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures).
• Enter into and maintain with its participating MIPS eligible clinicians an appropriate Business Associate agreement that provides for the qualified registry's receipt of patient-specific data from an individual MIPS eligible clinician or group, as well as the qualified registry's disclosure of quality measure results and numerator and denominator data and/or patient specific data on Medicare and non-Medicare beneficiaries on behalf of MIPS eligible clinicians or group.
• Obtain and keep on file signed documentation that each holder of an NPI whose data are submitted to the qualified registry, has authorized the qualified registry to submit quality measure results, improvement activities measure and activity results, advancing care information objective results and numerator and denominator data or patient-specific data on Medicare and non-Medicare beneficiaries to us for the purpose of MIPS participation. This documentation should be obtained at the time the MIPS eligible clinician or group signs up with the qualified registry to submit MIPS data to the qualified registry and must meet any applicable laws, regulations, and contractual business associate agreements. Groups participating in MIPS via a qualified registry may have their group's duly authorized representative grant permission to the qualified registry to submit their data to us. If submitting as a group each individual MIPS eligible clinician does not need to grant their individual permission to the qualified registry to submit their data to us.
• Not be owned and managed by an individual locally-owned single specialty group (for example, single specialty practices with only one practice location or solo practitioner practices are prohibited from self-nominating to become a MIPS qualified registry).
• Be able to separate out and report on all payers, including Medicare Part B FFS patients and non-Medicare patients.
• Provide the measure numbers for the MIPS quality measures on which the qualified registry is reporting.
• Provide the measure title (and specialty-specific measure set title, if applicable) for the MIPS quality measures and improvement activities (if applicable) on which the qualified registry is reporting.
• Indicate if the qualified registry will be reporting the advancing care information component measures and objectives.
• Report the number of eligible instances (reporting denominator).
• Report the number of instances a quality service is performed (performance numerator).
• Report the number of performance exclusions, meaning the quality action was not performed for a valid reason as defined by the measure specification.
• Comply with a CMS-specified secure method for data submission, such as submitting the qualified registry's data in an XML file.
• Sign a document verifying the qualified registry's name, contact information, cost for MIPS eligible clinicians or groups to use the qualified registry, services provided, and the specialty-specific measure sets the qualified registry intends to report. Once posted on the qualified registry's CMS Web site, the qualified registry will need to support the measures or measure sets confirmed by the qualified registry. Failure to do so will may preclude the qualified registry from participation in MIPS in the subsequent year.
• Must provide attestation statements during the data submission period that all of the data (quality measures, improvement activities, and advancing care information measures and objectives, if applicable) and results are accurate and complete.
• For purposes of distributing performance feedback to MIPS eligible clinicians, collect a MIPS eligible clinician's email address(es) and have documentation from the MIPS eligible clinician authorizing the release of his or her email address.
• Be able to calculate and submit measure-level reporting rates or, upon request, the data elements needed to calculate the reporting and performance rates by TIN/NPI and/or TIN.
• Be able to calculate and submit, by TIN/NPI or TIN, a performance rate (that is the percentage of a defined population who receive a particular process of care or achieves a particular outcome based on a calculation of the measures' numerator and denominator specifications) for each measure on which the TIN/NPI and/or TIN reports or, upon request the Medicare and non-Medicare level data elements needed to calculate the performance rates.
• Provide the performance period start date the qualified registry will cover.
• Provide the performance period end date the qualified registry will cover.
• Report the number of instances in which the applicable submission criteria were not met, for example, the quality measure was not reported and a performance exclusion did not apply.
• For data validation purposes, provide information on the entity's sampling methodology. For example, if is encouraged that 3 percent of the MIPS eligible clinicians be sampled with a minimum sample of 10 MIPS eligible clinicians or a maximum sample of 50 MIPS eligible clinicians. For each MIPS eligible clinician sampled, it is encouraged that 25 percent of the MIPS eligible clinicians' patients (with a minimum sample of five patients or a maximum sample of 50 patients) should be reviewed for all measures applicable to the patient.
The following is a summary of the comments we received regarding our proposal for the qualified registry criteria for data submission.
After consideration of the comments regarding qualified registry criteria for data submission we are finalizing the above policies as proposed with one modification. Based on our policies finalized in section II.E.5.b.(3) of this final rule with comment period, we are not requiring MIPS eligible clinicians to submit data on cross-cutting measures. Therefore, we are finalizing at § 414.1335(a)(1)(i) the requirement for registries as follows: Be able to submit results for at least six quality measures including one outcome measure. If an outcome measure is not available, be able to submit results for at least one other high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures). If no outcome measure is available, then the registry must provide a justification for not including an outcome measure.
As discussed in the proposed rule (81 FR 28188), we proposed to allow groups to report CAHPS for MIPS survey measures. We proposed the data collected on the CAHPS for MIPS survey measures would be transmitted to us via a CMS-approved survey vendor.
For purposes of MIPS, we proposed to define a CMS-approved survey vendor at § 414.1305 as a survey vendor that is approved by us for a particular performance period to administer the CAHPS for MIPS survey and transmit survey measures data to us. We proposed at § 414.1400(i) that vendors are required to undergo the CMS approval process for each year in which the survey vendor seeks to transmit survey measures data to us. We anticipate retaining the same policies and procedures we currently follow for a CMS-approved survey vendor for PQRS and apply them to a MIPS CMS-approved survey vendor. We proposed the following criteria for a CMS-approved survey vendor for the CAHPS for MIPS survey. A CMS-approved survey vendor for CAHPS for MIPS must:
(1) Comply with and complete the Vendor Participation Form—We anticipate retaining the same application process and Vendor Participation Form that was required for the CAHPS for PQRS survey. Please refer to
• Meet all of the Minimum Survey Vendor Business Requirements at the time of the submission of the Vendor Participation Form; and
• Complete the Vendor Participation Form.
(2) Comply with the Minimum Survey Vendor Business Requirements—We anticipate retaining the same minimum survey business requirements that were required for the CAHPS for PQRS survey. Please refer to
• Relevant organization and survey experience.
• Survey capability and capacity.
• Adherence to quality assurance guidelines and participation in quality assurance activities.
• Documentation requirements.
• Adhere to all protocols and specifications, and agree to participate in training sessions
Specifically, to obtain our approval, we proposed that survey vendors would be required to undergo training, meet our standards on how to administer the survey, and submit a quality assurance plan. We would provide the identified survey vendor with an appropriate sample frame of beneficiaries from each group that has contracted with the survey vendor and elected to participate in the CAHPS for MIPS survey. The survey vendor would also be required to administer the survey according to established protocols to ensure valid and reliable results. More information on quality assurance and protocols can be reviewed at
The following is a summary of the comments we received regarding the CMS-approved survey vendors.
After consideration of the comments regarding CMS-approved survey vendors we are finalizing §§ 414.1305 and 414.1400(i) and the above policies as proposed.
We proposed at § 414.1400(k) a process for placing third party intermediaries on probation and for disqualifying such entities for failure to meet certain standards established by CMS. Specifically, we proposed that if at any time we determine that a third party intermediary (that is, a QCDR, health IT vendor, qualified registry, or CMS-approved survey vendor) has not met all of the applicable criteria for qualification, we may place the third party intermediary on probation for the current performance period and/or the following performance period, as applicable.
In addition, we proposed that we require a corrective action plan from the
We proposed probation to mean that, for the applicable performance period, the third party intermediary would not be allowed to miss any meetings or deadlines and would need to submit a corrective action plan for remediation or correction of deficiencies identified that resulted in the probation.
In addition, we proposed that if the third party intermediary has data inaccuracies including (but not limited to) TIN/NPI mismatches, formatting issues, calculation errors, data audit discrepancies affecting in excess of 3 percent (but less than 5 percent) of the total number of MIPS eligible clinicians or groups submitted by the third party intermediary, we would annotate on the CMS qualified posting that the third party intermediary furnished data of poor quality and would place the entity on probation for the subsequent MIPS performance period with the opportunity to go on probation for a year to correct their deficiencies.
Further, we proposed if the third party intermediary does not reduce their data error rate below 3 percent for the subsequent performance period, the third party intermediary would continue to be on probation and have their listing on the CMS Web site continue to note the poor quality of the data they are submitting for MIPS for one additional performance year. After 2 years on probation, the third party intermediary would be disqualified for the subsequent performance year. Data errors affecting in excess of 5 percent of the MIPS eligible clinicians or groups submitted by the third party intermediary may lead to the disqualification of the third party intermediary from participation for the following performance period. In placing the third party intermediary on probation; we would notify the third party intermediary of the identified issues, at the time of discovery of such issues.
Finally, we proposed if the third party intermediary does not submit an acceptable corrective action plan within 14 days of notification of the deficiencies and correct the deficiencies within 30 days or before the submission deadline—whichever is sooner, we may disqualify the third party intermediary from participating in MIPS for the current performance period and/or the following performance period, as applicable. We requested comments on these proposals.
The following is a summary of the comments we received regarding probation and disqualification of a third party intermediary.
Some commenters proposed that at least 30 days be allowed for the corrective action plan and an additional 45 days to deploy the solution; the imminence of a reporting deadline should not limit the time available to deploy a solution; such haste could create additional problems for clinicians and CMS. The commenters also recommended that CMS have provisions in place to use updated data submitted after the reporting deadline. The commenters stated that 14 days could be much too little time to properly diagnose a problem and propose and test a solution. Similarly, 30 days could be much too little time to deploy a solution that could require patching software and changes in clinician workflows.
Other commenters stated that timeframes in this section are unreasonably short and recommended they be extended. They believed that it is unreasonable for CMS to expect that a health IT vendor would be able to verify that a problem exists, identify and troubleshoot the source of the problem, and present a precise solution for correcting the problem, within 14 days. The commenters requested that CMS extend this to 30 days, at a minimum. The commenters believed for the correcting deficiencies, 30 days may be unreasonably short and depending on the nature of the problem, believed it can take anywhere from a week to several months to program a software patch, and even longer to correct the problem through a software upgrade. The commenters requested that CMS extend this to 90 days, at a minimum.
Another commenter believed it would be virtually impossible for most QCDRs to meet the 3 percent error rate criteria to avoid the low data quality notation and threatened probation. The commenter recommended that CMS review the proposal for a 3 percent error rate and adopt an error rate that is more feasible for QCDRs to achieve at this early stage in their development. A few commenters stated it will be important not to penalize submitters with errors in calculations in excess of the three to five percent in the proposed rule if the calculation error is due to a different interpretation of an imprecisely-specified measure.
After consideration of the comments regarding auditing of third party intermediaries submitting MIPS data, we are finalizing the proposal at § 414.1400(k) to include that if at any time we determine that a third party intermediary (that is, a QCDR, health IT vendor, qualified registry, or CMS-approved survey vendor) has not met all of the applicable criteria for qualification, we may place the third party intermediary on probation for the current performance period and/or the following performance period, as applicable. In addition, we are finalizing that we require a corrective action plan from the third party intermediary to address any deficiencies or issues and prevent them from recurring. We are finalizing the corrective action plan must be received and accepted by us within 14 days of the CMS notification to the third party intermediary of the deficiencies or probation. Failure to comply with this would lead to disqualification from MIPS for the subsequent performance period. In addition, we are finalizing that probation means for the applicable performance period, the third party intermediary would not be allowed to miss any meetings or deadlines and would need to submit a corrective action plan for remediation or correction of deficiencies identified that resulted in the probation. Further, we are finalizing that if the third party intermediary has data inaccuracies including (but not limited to) TIN/NPI mismatches, formatting issues, calculation errors, data audit discrepancies affecting in excess of 3 percent (but less than 5 percent) of the total number of MIPS eligible clinicians or groups submitted by the third party intermediary, we would annotate on the CMS qualified posting that the third party intermediary furnished data of poor quality and would place the entity on probation for the subsequent MIPS performance period with the opportunity to go on probation for a year to correct their deficiencies. In addition, we are finalizing that if the third party intermediary does not reduce their data error rate below 3 percent for the subsequent performance period, the third party intermediary would continue to be on probation and have their listing on the CMS Web site continue to note the poor quality of the data they are submitting for MIPS for one additional performance year. After 2 years on probation, the third party intermediary would be disqualified for the subsequent performance year. Data errors affecting in excess of 5 percent of the MIPS eligible clinicians or groups submitted by the third party intermediary may lead to the disqualification of the third party intermediary from participation for the following performance period. In placing the third party intermediary on probation; we would notify the third party intermediary of the identified issues, at the time of discovery of such issues. Further, we are finalizing that if the third party intermediary does not submit an acceptable corrective action plan within 14 days of notification of the deficiencies and correct the deficiencies within 30 days or before the submission deadline—whichever is sooner, we may disqualify the third party intermediary from participating in MIPS for the current performance period and/or the following performance period, as applicable.
We proposed at § 414.1400(j) that any third party intermediary (that is, a QCDR, health IT vendor, qualified registry, or CMS-approved survey vendor) must comply with certain auditing criteria as a condition of their qualification or approval to participate in MIPS as a third party intermediary. Specifically, we proposed the entity must make available to us the contact information of each MIPS eligible clinician or group on behalf of whom it submits data. The contact information would include, at a minimum, the MIPS eligible clinician or group's practice phone number, address, and, if available, email. Further, we proposed the entity must retain all data submitted to us for MIPS for a minimum of 10 years. We requested comments on this proposal.
The following is a summary of the comments we received regarding auditing of third party intermediaries submitting MIPS data.
Another commenter stated that CMS should only require a QCDR to obtain and keep on file signed documentation that each holder of an NPI whose data is submitted to the QCDR and who has authorized the QCDR to submit quality measure results, improvement activities (if applicable), advancing care information objective results and numerator and denominator data (if applicable) and/or patient-specific data on Medicare and non-Medicare beneficiaries to CMS for the purpose of MIPS participation for 3 years beyond each reporting year for which a user participates via the QCDR.
After consideration of the comments regarding auditing of third party intermediaries submitting MIPS data, we are modifying the proposal at § 414.1400(j) to include the proposed policies that any third party intermediary (that is, a QCDR, health IT vendor, qualified registry, or CMS-approved survey vendor) must comply with the following procedures as a condition of their qualification and approval to participate in MIPS as a third party intermediary: (1) The entity must make available to CMS the contact information of each MIPS eligible clinician or group on behalf of whom it submits data. The contact information will include, at a minimum, the MIPS eligible clinician or group's practice phone number, address, and, if available, email; and (2) the entity must retain all data submitted to CMS for MIPS for a minimum of 10 years. In addition, we are adding that for the purposes of auditing, CMS may request any records or data retained for the purposes of MIPS for up to 6 years and 3 months.
This section contains the approach for public reporting on Physician Compare for the MIPS, APM, and other information as required by the MACRA.
Physician Compare draws its operating authority from section 10331(a)(1) of the Affordable Care Act. As required, by January 1, 2011, we developed a Physician Compare Internet Web site with information on physicians enrolled in the Medicare program under section 1866(j) of the Act, as well as information on other EPs who participate in the PQRS under section 1848 of the Act. More information about Physician Compare can be accessed on the Physician Compare Initiative Web site at
The first phase of Physician Compare was launched on December 30, 2010 (
Consistent with section 10331(a)(2) of the Affordable Care Act, Physician Compare also phased in public reporting of information on physician performance that provides comparable information on quality and patient experience measures for reporting periods beginning January 1, 2012. To the extent that scientifically sound measures are developed and are available, Physician Compare is required to include, to the extent practicable, the following types of measures for public reporting, for example: Measures collected under PQRS and an assessment of efficiency, patient health outcomes, and patient experience, as specified. The first set of quality measures were publicly reported on Physician Compare in February 2014. Currently, Physician Compare publicly reports 14 group practice level measures collected through the Web Interface for groups of 25 or more EPs participating in 2014 under the PQRS and for ACOs participating in the Shared Savings Program or Pioneer ACO program, and six individual level measures collected through claims for individual EPs participating in 2014 under the PQRS. A complete history of public reporting on Physician Compare is detailed in the CY 2016 PFS final rule (80 FR 71117 through 71122).
As finalized in the CY 2015 and CY 2016 PFS final rules (79 FR 67547 and 80 FR 70885) Physician Compare will expand public reporting over the next several years. This expansion includes publicly reporting both individual EP (now referred to as clinician) and group practice level QCDR measures starting with 2015 individual clinician measures on Physician Compare in late 2016, and expanding public reporting of group practice QCDR measures in late 2017 (80 FR 71125).
Section 1848(q)(9)(A) and (D) of the Act facilitates the continuation of the phased approach to public reporting by requiring the Secretary to make available on the Physician Compare Web site, in an easily understandable format, individual MIPS eligible clinician and groups performance information, including:
• The MIPS eligible clinician's final score;
• The MIPS eligible clinician's performance under each MIPS performance category (quality, cost, improvement activities, and advancing care information);
• Names of eligible clinician's in Advanced APMs and, to the extent feasible, the names of such Advanced APMs and the performance of such models; and
• Aggregate information on the MIPS, posted periodically, including the range of final scores for all MIPS eligible clinician's and the range of the performance of all MIPS eligible clinician's for each performance category.
The proposals related to each of these requirements are addressed below.
Section 1848(q)(9)(B) of the Act also requires that this information indicate, where appropriate, that publicized information may not be representative of the eligible clinician's entire patient population, the variety of services furnished by the eligible clinician, or the health conditions of individuals treated. The information mandated for Physician Compare under section 1848(q)(9) of the Act will generally be publicly reported consistent with section 10331(a)(2) and 10331(b) of the Affordable Care Act, and like all measure data included on Physician Compare, will be comparable. In addition, section 10331(b) of the Affordable Care Act requires that we include, to the extent practicable, processes to ensure that data made public are statistically valid, reliable, and accurate, including risk adjustment mechanisms used by the Secretary. In addition to the public reporting standards identified in the Affordable Care Act—statistically valid and reliable data that are accurate and comparable—we have established a policy that, as determined through consumer testing, the data we disclose generally should resonate with and be accurately interpreted by consumers to be included on Physician Compare profile pages. Together, we refer to these conditions as the Physician Compare public reporting standards (80 FR 71118 through 71120). Section 10331(d) of the Affordable Care Act also requires us to consider input from multi-stakeholder groups, consistent with sections 1890(b)(7) and 1890A of the Act. We also continue to receive general input from stakeholders on Physician Compare through a variety of means, including rulemaking and different forms of stakeholder outreach (for example, Town Hall meetings, Open Door Forums, webinars, education and outreach, Technical Expert Panels, etc.).
In addition, section 1848(q)(9)(C) of the Act requires the Secretary to provide an opportunity for MIPS eligible clinicians to review the information that will be publicly reported prior to such information being made public. This is generally consistent with section 10331(a)(2) of the Affordable Care Act, under which we have established a 30-day preview period for all measurement performance data that allows physicians and other eligible clinicians to view their data as it will appear on the Web site in advance of publication on Physician Compare (80 FR 71120). Section 1848(q)(9)(C) of the Act also requires that MIPS eligible clinicians be able to submit corrections for the information to be made public. We proposed that this extension of the current Physician Compare 30-day preview period will be implemented starting with data from the 2017 MIPS performance period. We proposed a 30-day preview period in advance of the publication of data on Physician Compare (81 FR 28290). We proposed to coordinate efforts between Physician Compare and the four performance categories of MIPS in terms of data review and any relevant data resubmission or correction. All data available for public reporting—measure rates, scores, and attestations—would be available for review and correction during the targeted review process (81 FR 28278). The process would begin at least 30 days in advance of the publication of new data. Data under review will not be publicly reported until the review is complete. All corrected measure rates, scores, and attestations submitted would be available for public reporting. The technical details of the process would be communicated directly to affected MIPS eligible clinicians and groups and detailed outside of rulemaking.
As with the current process, the details would be made public on the Physician Compare Initiative page on cms.gov and communicated through Physician Compare and other CMS listservs.
The following is a summary of the comments we received regarding our proposal to implement a 30-day preview
After consideration of the comments, we are finalizing our policy as proposed. As consistent with current practice (80 FR 71120), we are adopting a 30-day preview period in advance of the publication of data on Physician Compare.
In addition, section 1848(q)(9)(D) of the Act requires that aggregate information on the MIPS be periodically posted on the Physician Compare Web site; including the range of final scores for all MIPS eligible clinicians and the range of performance for all MIPS eligible clinicians for each performance category.
Lastly, section 104(e) of the MACRA requires the Secretary to make publicly available, on an annual basis (beginning with 2015), in an easily understandable format, information for physicians and other eligible clinician's on items and services furnished to Medicare beneficiaries, and to include, at a minimum:
• Information on the number of services furnished under Part B, which may include information on the most frequent services furnished or groupings of services;
• Information on submitted charges and payments for Part B services; and
• A unique identifier for the physician or other eligible clinician that is available to the public, such as an NPI.
The information would further be required to be made searchable by at least specialty or type of physician or other eligible clinician; characteristics of the services furnished (such as, volume or groupings of services); and the location of the physician or other eligible clinician.
Therefore, at § 414.1395(a) we proposed public reporting of an eligible clinician's MIPS data; in that for each program year, we would post on a public Web site, in an easily understandable format, information regarding the performance of MIPS eligible clinicians or groups under the MIPS. This proposal and related public comments are addressed in detail below.
Furthermore, in accordance with section 104(e) of the MACRA, we finalized a policy in the CY 2016 PFS final rule (80 FR 71130) to add utilization data to the Physician Compare downloadable database. Utilization data is currently available at
We believe section 10331 of the Affordable Care Act supports our overarching goals of the MACRA by providing consumers with quality information that will help them make informed decisions about their health care, while encouraging clinicians to improve the quality of care they provide to their patients. In accordance with section 10331 of the Affordable Care Act, section 1848(q)(9) of the Act, and section 104(e) of the MACRA, we plan to continue to publicly report performance information on Physician Compare. As a result, we proposed inclusion of the following information on Physician Compare (81 FR 28291 through 28293).
As noted, section 1848(q)(9)(A) and (D) of the Act requires that we publicly report on Physician Compare the final score for each MIPS eligible clinician, performance of each MIPS eligible clinician for each performance category, and periodically post aggregate information on the MIPS, including the range of final scores for all MIPS eligible clinicians and the range of performance of all the MIPS eligible clinicians for each performance category. We proposed that these data would be added to Physician Compare for each MIPS eligible clinician or group, either on the profile pages or in the downloadable database, as technically feasible. Statistical testing and consumer testing, as well as consultation of the Physician Compare Technical Expert Panel (TEP), would determine how and where these data are reported on Physician Compare. We requested comments on these proposals.
The following is a summary of the comments we received regarding our proposal to publicly report on Physician Compare the final score for each MIPS eligible clinician, performance of each MIPS eligible clinician for each performance category, and periodically post aggregate information on the MIPS, including the range of final scores for all MIPS eligible clinicians and the range of performance of all the MIPS eligible clinicians for each performance category.
Some commenters believe all category scores should be visible on Physician Compare rather than just the final score noting the final score oversimplifies performance without taking into consideration things like higher costs. Another commenter recommended that in the first few years of MIPS data be shared only with clinicians and after this period consider all MIPS data for public reporting.
Other commenters suggested that CMS implement precautions before releasing certain information (for example, quality, cost, and utilization data) on Physician Compare as individualized data without explanation could be misleading, and instead encouraged CMS to release this information only to professional societies. Another commenter encouraged CMS to include contextual information to clarify which eligible clinicians could and could not submit data in the first 2 years of MIPS so lack of reporting is not misinterpreted by consumers.
Additional commenters encouraged CMS to obtain ample feedback from patients and clinicians prior to posting information to Physician Compare to ensure that public reporting standards are upheld, including the requirement that all data resonate with and be accurately interpreted by consumers. Another commenter stated it is important for CMS to determine the accuracy of the data posted on Physician Compare.
The statistical and consumer testing done ensures the data are accurate, they represent quality of care, and they are well understood and correctly interpreted by consumers. The nature of how clinicians and groups are searched on Physician Compare facilitates comparison within specialty, not across. And, language is currently available on the site to explain that lack of data does not mean lack of quality care, and this concept has been well understood in previous consumer testing. Previous testing has also shown that consumers not only accurately interpret but need aggregate scoring, such as composite scores and star ratings, to best understand what are often complex data. These aggregations are not oversimplifications, but beneficial tools for the average consumer to use to best interpret the data. And, although we appreciate the request to have more time to learn from and improve on the data collected, as a continuation of the existing public reporting plan, we believe clinicians have had the opportunity to benefit from previous years of data submission as public reporting was slowly phased in under the PQRS and the data under MIPS are well timed for public reporting.
After consideration of the comments and for the reasons we explained previously, we are finalizing our proposal to report on Physician Compare the final score for each MIPS eligible clinician, performance of each MIPS eligible clinician for each performance category, and to periodically post aggregate information of such data. Accordingly, we are finalizing § 414.1395(a), which provides
In addition, we solicited comment on the advisability and technical feasibility of including data voluntarily reported by eligible clinicians and groups that are not subject to MIPS payment adjustments, such as those practicing through RHCs, FQHCs, etc., on Physician Compare, which would be addressed through separate notice-and-comment rulemaking.
The following is a summary of the comments we received regarding our solicitation of comments for including data voluntarily reported by eligible clinicians and groups that are not subject to MIPS payment adjustments.
As detailed in the proposed rule, consistent with the current policy that makes all current PQRS measures available for public reporting, we proposed to make all measures under the MIPS quality performance category (81 FR 28184) available for public reporting on Physician Compare (81 FR 28291). This would include all available measures reported via all available submission methods, and applies to both MIPS eligible clinicians and groups. Also consistent with current policy, although all measures will be available for public reporting not all measures will be made available on the consumer-facing Web site profile pages. As explained in the proposed rule (81 FR 28291), providing too much information can overwhelm consumers and lead to poor decision making. Therefore, consistent with section 1848(q)(9)(A)(i)(II) of the Act, we proposed that all measures in the quality performance category that meet the statistical public reporting standards would be included in the downloadable database, as technically feasible. We also proposed that a subset of these measures would be publicly reported on the Web site's profile pages, as technically feasible, based on consumer testing. Statistical testing and consumer testing would determine how and where measures are reported on Physician Compare. In addition, we proposed to apply our existing policy of not publicly reporting first year measures, meaning new measures that have been in use for less than 1 year, regardless of submission methods. After a measure's first year in use, we would evaluate the measure to see if and when the measure is suitable for pubic reporting (81 FR 28291).
Currently, there is a minimum sample size requirement of 20 patients for performance data to be included on the Web site. As part of the MIPS and APMs RFI we asked for comment on moving away from this requirement and moving to a reliability threshold for public reporting. In general, commenters supported a minimum reliability threshold. As a result, we proposed to institute a minimum reliability threshold for public reporting this data on Physician Compare (81 FR 28291).
The reliability of a measure refers to the extent to which the variation in measure is due to variation in quality of care as opposed to random variation due to sampling. Statistically, reliability depends on performance variation for a measure across entities, the random variation in performance for a measure within an entity's panel of attributed beneficiaries, and the number of beneficiaries attributed to the entity. High reliability for a measure suggests that comparisons of relative performance across entities, in this case groups or eligible clinicians, are likely to be stable and consistent, and that the performance of one entity on the quality measure can confidently be distinguished from another. Conducting analysis to determine reliability of the data collected will allow us to calculate the minimum reliability threshold for those data. Once an appropriate minimum reliability threshold is determined, the reporting of reporters' performance rates for a given measure can be restricted to only those meeting the minimum reliability threshold.
We proposed to also include the total number of patients reported on per measure in the downloadable database to facilitate transparency and more accurate understanding and use of the data. We requested comments on these proposals (81 FR 28291).
We also solicited comment on the types of data that should be reported on Physician Compare as the MIPS program evolves, specifically in regard to the quality performance category. Any regulatory changes would be made in separate notice-and-comment rulemaking.
The following is a summary of the comments we received regarding our proposal related to public reporting data from the MIPS quality performance category (81 FR 28291).
After consideration of the comments and for the reasons we discussed in this final rule with comment period, we are finalizing our policies as proposed.
As detailed in the proposed rule, we proposed, consistent with section 1848(q)(9)(A)(i)(II) of the Act, to make all measures under the MIPS cost performance category (see 81 FR 28196) available for public reporting on Physician Compare. This includes all available measures reported via all available submission methods, and applies to both MIPS eligible clinicians and groups.
We have found that cost data do not resonate with consumers and can instead lead to significant misinterpretation and misunderstanding. Therefore, we proposed to include a sub-set of cost measures, that meet the aforementioned public reporting standards, on Physician Compare, either on profile pages or in the downloadable database, if technically feasible (81 FR 28291 through 28292). Statistical testing and consumer testing would determine how and where measures are reported on Physician Compare. In addition, we proposed not to publicly report first year measures, meaning new measures that have been in use for less than 1 year, regardless of submission methods. After a measure's first year in use, we would evaluate the measure to see if and when the measure is suitable for pubic reporting (81 FR 28292). We requested comments on these proposals.
We also solicited comment on the types of data that should be reported on Physician Compare as the MIPS program evolves, specifically in regard to the cost performance category. Any regulatory changes would be made in separate notice-and-comment rulemaking.
The following is a summary of the comments we received regarding our proposal related to public reporting of data from the MIPS cost performance category.
Another commenter appreciated the proposal to limit public reporting on the Physician Compare Web site to a subset of cost measures that meet the public reporting standards, and to include the total number of patients reported on per measure in the downloadable database so that quality data is accurately interpreted per practice size.
After consideration of the comments and for the reasons we discussed in this final rule with comment period, we are finalizing our policies as proposed. Based on the policies being finalized in II.E.5.e. of this final rule with comment period we may not have data for public reporting in year 1, the transition year, of MIPS for the cost performance category.
As detailed in the proposed rule, we proposed, consistent with section 1848(q)(9)(A)(i)(II) of the Act, to make all activities under the MIPS improvement activities performance category (81 FR 28209) available for public reporting on Physician Compare (81 FR 28292). This includes all available improvement activities reported via all available submission methods, and applies to both MIPS eligible clinicians and groups.
We proposed to include a subset of improvement activities data that meet the aforementioned public reporting standards, on Physician Compare, either on the profile pages or in the downloadable database, if technically feasible (81 FR 28292). For those eligible clinicians that successfully meet the improvement activities performance category requirements this may be posted on Physician Compare as an indicator. The improvement activities performance category is a new field of data for Physician Compare so concept and consumer testing will be needed to ensure these data are understood by consumers. Therefore, we proposed that statistical testing and consumer testing would determine how and where improvement activities are reported on Physician Compare. In addition, since we do not publicly report first year measures, we proposed to also apply this policy to improvement activities, meaning new improvement activities that have been in use for less than 1 year, regardless of submission methods. After an improvement activity's first year in use, we would evaluate the activity to see if and when the activity is suitable for pubic reporting (80 FR 71118). We requested comments on these proposals.
We also solicited comment on the types of data that should be reported on Physician Compare as the MIPS program evolves, specifically in regard to the improvement activities performance category. Any regulatory changes would be made in separate notice-and-comment rulemaking.
The following is a summary of the comments we received regarding our proposal related to public reporting of data from the MIPS improvement activities performance category.
After consideration of the comments and for the reasons we articulated previously, we are finalizing our policies as proposed.
Since the beginning of the EHR Incentive Programs in 2011, participant performance data has been publicly available in the form of public use files on the CMS Web site. In the 2015 EHR Incentive Programs final rule, we addressed comments requesting that we not only continue this practice but also include a wider range of information on participation and performance. In that rule, we stated our intent to publish the performance and participation data on Stage 3 objectives and measures of meaningful use in alignment with quality programs which utilize publicly available performance data such as Physician Compare (80 FR 62901). At this time there is only a green check mark on Physician Compare profile pages to indicate that an eligible clinician successfully participated in the current Medicare EHR Incentive Program for eligible clinicians.
As MIPS will now include advancing care information as one of the four MIPS performance categories, we proposed, consistent with section 1848(q)(9)(i)(II) of the Act, to include more information on an eligible clinician's performance on the objectives and measures of meaningful use on Physician Compare (81 FR 28292). An important consideration is that to meet the aforementioned public reporting standards, the data added to Physician Compare must resonate with the average Medicare consumer and their caregivers. Consumer testing to date has shown that people with Medicare value the use of certified EHR technology and see EHR use as something that if used well can improve the quality of their care. In addition, we believe the inclusion of indicators for clinicians who achieve high performance in key care coordination and patient engagement activities provide significant value for consumers.
We therefore proposed to include an indicator for any eligible clinician or group who successfully meets the advancing care information performance category, as detailed in the proposed
We also solicited comment on potentially including an indicator to show low performance in the advancing care information performance category, as well as, the types of data that should be reported on Physician Compare as the MIPS program evolves, specifically in regard to the advancing care information performance category. Additionally, we would need to perform consumer testing and evaluate the feasibility of potentially including an indicator to show low performance in the advancing care information performance category to ensure this is understood by consumers. Any regulatory changes would be made in separate notice-and-comment rulemaking.
The following is a summary of the comments we received regarding our proposal related to public reporting of data from the MIPS advancing care information performance category.
After consideration of the comments and for the reasons we discussed in this final rule with comment period, we are finalizing our policies as proposed.
We previously finalized a policy to include utilization data in the Physician Compare downloadable database in late 2017 using the most currently available data (80 FR 71130) to meet section 104(e) of the MACRA. As there are thousands of Healthcare Common Procedure Coding System (HCPCS) codes in use, not all available data will be included. The specific HCPCS codes included will be determined based on analysis of the available data, focusing on the most used codes. The goal will be to include counts that can facilitate a greater understanding and more in-depth analysis of the other measure and performance data being made available. We proposed to continue to include utilization data in the Physician Compare downloadable database (81 FR 28292). We requested comment on this proposal.
The following is a summary of the comments we received regarding our proposal to continue to include utilization data in the Physician Compare downloadable database.
After consideration of the comments and for the reasons we articulated, we are finalizing the policy as proposed.
As discussed above, section 1848(q)(9)(A)(ii) of the Act requires us to publicly report names of eligible clinicians in Advanced APMs and, to the extent feasible, the names and performance of Advanced APMs. We see this as an opportunity to continue and build on reporting we are now doing of ACO data on Physician Compare. At this time, if a clinician or group submitted quality data as part of an ACO, there is an indicator on the clinician's or group's profile page indicating this. In this way, it is known which clinicians and groups took part in an ACO. Also, currently, all ACOs have a dedicated page on the Web site to showcase their data. If technically feasible, we proposed to use this model as a guide as we add APM data to Physician Compare. We proposed to indicate on eligible clinician and group profile pages when the eligible clinician or group is participating in an APM (81 FR 28293). We also proposed to link eligible clinicians and groups to their APM's data, as relevant and possible, through Physician Compare. Data posting would be considered for both Advanced APMs and APMs that are not considered Advanced APMs.
At the outset, APMs will be very new concepts for consumers. Testing shows that at this time, ACOs are not a familiar concept to the average Medicare consumer. It is very easy for consumers to misunderstand an ACO as just a type of group. We expect at least the same lack of familiarity when introducing the broader concept of APM, of which ACOs comprise only one type. In these early years, indicating who participated in APMs and testing language to accurately explain that to consumers provides useful and valuable information as we continue to evolve Physician Compare. As we come to understand how to best explain this concept to consumers, we can continue to assess how to most fully integrate these data on the Web site. We requested comment on these proposals.
The following is a summary of the comments we received regarding our proposal to publicly report names of eligible clinicians in Advanced APMs and, to the extent feasible, the names and performance of Advanced APMs.
After consideration of the comments and for the reasons we set forth, we are finalizing this policy as proposed.
Some of the comments received did not specifically relate to the public reporting proposals in the proposed rule. The following is a summary of these miscellaneous comments.
One commenter supported the inclusion of ABMS board certification and participation in Maintenance of Certification (MOC) Programs on Physician Compare. Another commenter recommended MOC participation as a measure in future rulemaking as part of quality performance data publicly reported on Physician Compare.
One commenter believed that payers, providers, large group purchasers, and consumers should be fully empowered to access, use, share, contribute, and benefit from data that improve their health care decision making. Another commenter recommended including Medicare Advantage plan quality information that is comparable to FFS information on Physician Compare. One commenter recommended that Physician Compare provide comparative quality information and comparative pricing data across services; estimated costs for in network and out of network costs; allow consumer to customize the provider information to highlight the most relevant information; expand provider information to include the most relevant topics for consumers, such as patient-reported outcome measures; online decision-support tools, as well as assistive and cognitive technology tools.
One commenter recommended CMS provide a method for comparing IHS, Tribal, and urban Indian providers. The commenter also recommended that CMS remain aware of these providers as distinct when collecting and reporting data.
One commenter recommended providing a disclaimer that publicly reported final scores are not admissible judicially. Another commenter recommended a disclaimer on Physician Compare that performance information should not be used to determine whether an act of medical negligence has occurred.
One commenter recommended that CMS provide a disclaimer where insufficient performance data exists on Physician Compare which explains why certain eligible clinicians do not have data publicly reported. Another commenter recommended that CMS indicate whether an eligible clinician has been excluded from reporting data so consumers do not potentially misinterpret limited performance data on the eligible clinicians profile page.
One commenter recommended a principal focus be on providing reliable and useful data rather than expediency.
Section 1833(z) of the Act, as added by section 101(e)(2) of the MACRA, requires that an incentive payment be made to Qualifying APM Participants (QPs) for participation in eligible alternative payment models (referred to as Advanced APMs). Key statutory elements of the incentives for participation in Advanced APMs under the Quality Payment Program addressed in the proposed rule include:
• Beginning in 2019, if an eligible clinician participates in a certain type of APM (an Advanced APM), that eligible
• For years from 2019 through 2024, QPs receive a lump sum incentive payment equal to 5 percent of their prior year's payments for Part B covered professional services, and beginning in 2026, QPs receive a higher update under the PFS than non-QPs.
• For 2019 and 2020, eligible clinicians may become QPs only through participation in Advanced APMs.
• For 2021 and later, eligible clinicians may become QPs through a combination of participation in Advanced APMs and Other Payer Advanced APMs.
This section of the rule discusses public comments and finalizes the definitions, requirements, procedures, and thresholds of participation that will govern this program.
Several core policy principles are derived from both the MACRA law and the Department's broad vision for better care, smarter spending, and healthier people. These principles drive many of our decisions in developing the overall framework for making APM Incentive Payments to QPs and for approaching interactions between MIPS and APMs discussed in the proposed rule. In addition to increasing the quality and efficiency of care delivered in the Medicare program and across the health system, these principles include the following seven goals:
• To the greatest extent possible, continue to build a portfolio of APMs that collectively allows participation for a broad range of physicians and other practitioners. We believe finding better ways to deliver care across settings and specialties can lead to improved health outcomes and more efficient health care spending. Doing this requires active CMS engagement with stakeholders, as well as input from those stakeholders to refine ideas in ways that meet statutory and delivery system reform goals.
• Design the program such that the APM Incentive Payment is attainable by increasing numbers of Advanced APM participants over time, yet remains reserved for those eligible clinicians participating in organizations that are truly engaged in care transformation. We believe the structure of the law is clear in that the APM Incentive Payments are earned through participation in APMs that are designed to be challenging and involve rigorous care improvement activities. In general, we believe eligible clinicians that receive incentives should be those who: take on financial risk for potential losses under an APM; are accountable for performance based on meaningful quality metrics; and use certified EHR technology.
• Maximize participation in both Advanced APMs and other APMs. Although we want to maintain high standards for eligible clinicians to earn the APM Incentive Payment, we also want to enable and encourage high levels of participation in a broad range of APMs, including those that are not Advanced APMs. We believe participation in any APM offers eligible clinicians and beneficiaries significant benefits.
• Create policies that allow for flexibility in future innovative Advanced APMs. We do not want to constrain the robust development of new Advanced APMs by framing standards only in terms of today's APMs but rather in ways that allow many avenues for meeting the Advanced APM criteria.
• Support multi-payer models and participation in innovative models in Medicaid and commercial markets in order to promote high quality and efficient care across the health care market.
• Minimize burden on organizations and professionals. Between APM participation and MIPS reporting, we hope to coordinate administrative processes, minimize overall reporting burden, and make transitioning between being a QP and being subject to MIPS as seamless as possible.
• We do not intend to create additional performance assessments or audits beyond those specified under an APM. Rather, we believe the process for determining whether an eligible clinician receives the APM Incentive Payment should focus on the relative degree of participation by eligible clinicians in Advanced APMs, not on their performance within the APM. The Quality Payment Program does not alter how each particular APM measures and rewards success within its design. Rather, it rewards a substantial degree of participation in certain APMs.
The incentives for Advanced APM participation established by the statute include several sets of related requirements that must be met. Three distinct roles play important parts in the program structure: (1) The Advanced Alternative Payment Model (Advanced APM), which is a health care payment and/or delivery model that includes payment arrangements and other design elements as part of a particular approach to care improvement and that by its design satisfies the criteria set forth in section 1833(z) of the Act; (2) the Advanced APM Entity, which is the entity participating in the Advanced APM; and (3) the eligible clinician, who is the individual physician or practitioner, or group of physicians or practitioners, who is a participant of the Advanced APM Entity and may be determined to be a QP.
In this final rule with comment period, we describe a series of steps that result in the determination of certain eligible clinicians as QPs for a particular year (the payment year). QPs will receive the APM Incentive Payment as specified in section 1833(z) of the Act for each of the years they qualify from 2019 through 2024, and the differential update incentive in section 1848(d)(20) of the Act for each of the years they qualify beginning in 2026. Per section 1833(z)(1)(A) of the Act, the APM Incentive Payment that an eligible clinician receives as a QP for a year between 2019 and 2024 is a lump sum payment equal to 5 percent of the QP's estimated aggregate payments for Medicare Part B covered professional services (services paid under or based on the Medicare PFS) for the prior year. Eligible clinicians who are QPs for a year are also excluded from MIPS for that year. In addition, beginning in 2026, QPs receive a higher Medicare PFS update (the “qualifying APM conversion factor”) than non-QPs. This QP determination is made for one calendar year at a time.
The steps that will result in a QP determination can be summarized as follows: (1) We determine whether the design of an APM meets three specified criteria for it to be deemed an Advanced APM; (2) an entity (the Advanced APM Entity) with a group of individual eligible clinicians participates in the Advanced APM; (3) we determine whether, during a performance period (the QP Performance Period), the eligible clinicians in the Advanced APM Entity collectively have at least a specified percentage of their aggregate Medicare Part B payments for covered professional services, or patients who received covered professional services, through the Advanced APM; (4) all of the eligible clinicians in the Advanced APM Entity are designated QPs for the payment year associated with that QP Performance Period. Those QPs would receive the 5 percent lump-sum APM Incentive Payments mentioned above for the payment year. This QP determination process would occur each year following the QP Performance Period, with the first payment year being 2019. Figure B illustrates the
The following is a summary of the comments we received generally regarding the incentives for participation in Advanced APMs.
Some commenters appreciated that the inception of this part of the Quality Payment Program will serve as a catalyst for more Advanced APMs and an acceleration of the movement from volume- to value-based payment. One commenter expressed concern that the process used to create and approve new Advanced APMs is too slow. One commenter expressed concern that because QPs in an Advanced APM Entity can earn the 5 percent APM Incentive Payment without demonstrating improved quality, controlled cost, or both, there will be no change to health care delivery, and that clinicians would not have a strong incentive to change their practice patterns. One commenter recommended CMS evaluate its overall approach and perhaps abandon Advanced APMs.
We plan to achieve these goals in the immediate and long-term future by expanding opportunities for clinicians to participate in existing Advanced APMs, changing certain existing APMs to meet the Advanced APM criteria, and developing new Advanced APMs, especially based on recommendations from the PTAC. The PTAC is discussed in section II.F.10. of this final rule with comment period. We note that not all models that are derived from PTAC recommendations must be Advanced APMs.
The incentives for Advanced APM participation, as specified under section 1833(z) of the Act, do not provide for consideration of eligible clinicians' performance in terms of quality, cost, or other factors in making determinations as to whether eligible clinicians are QPs for a year. However, we believe the performance requirements that are applicable to eligible clinicians under each Advanced APM will incentivize participants to make improvements in care delivery so as to improve quality of care and reduce expenditures. Additionally, the Transforming Clinical Practice Initiative (TCPI) is a $685 million CMS Innovation Center initiative designed to support 140,000 clinicians in sharing, adopting, and further developing comprehensive quality improve strategies, which are expected to lead to greater improvements in patient health and reduction in health care costs.
In regard to the request for transitional pathways to Advanced APM participation, section 1848(q)(11) of the Act provides $100 million in funding over 5 years for CMS to provide technical assistance to help clinicians develop the capabilities to be successful
The planned technical assistance will support small practices by helping them think through what they need to be successful under the Quality Payment Program, such as what quality measures and/or EHR may be appropriate for their practices' needs. The planned technical assistance would also educate clinicians about clinical practice improvement activities and how these activities could fit into their practices' workflow, or help practices evaluate their options for joining an APM. We believe this technical assistance, combined with our continued outreach and education efforts, will provide substantial support to eligible clinicians in their transition into APMs and Advanced APMs.
The APM track of the Quality Payment Program uses a set of interrelated defined terms. The basis for some core terms are set forth at sections 1833(z)(3) and 1848(q)(1)(C)(iii) of the Act, and others we will define in this final rule with comment period.
We use the statutory text as a foundation to develop definitions for other key terms used in this final rule with comment period. The terms cover three primary topics: (1) The different types of APMs and their participating entities and clinicians; (2) the timing, process and thresholds for determining QPs and Partial Qualifying APM Participants (Partial QPs); and (3) the payment of the 5 percent lump sum incentive (APM Incentive Payment) to QPs.
We are finalizing definitions for the following terms specific to incentives for participation in Advanced APMs, which are located at § 414.1302 of new subpart O:
• Affiliated Practitioner.
• APM Entity.
• APM Incentive Payment.
• Attributed beneficiary.
• Attribution-eligible beneficiary.
• Alternative Payment Model (APM).
• Advanced Alternative Payment Model (Advanced APM).
• Advanced APM Entity.
• Eligible clinician.
• Episode payment model.
• Incentive Payment Base Period.
• Medicaid APM.
• Medicaid Medical Home Model.
• Medical Home Model.
• Other Payer Advanced APM.
• Other payer arrangement.
• Partial Qualifying APM Participant (Partial QP).
• Partial QP Patient Count Threshold.
• Partial QP Payment Amount Threshold.
• Qualifying APM Participant (QP).
• QP Patient Count Threshold.
• QP Payment Amount Threshold.
• QP Performance Period.
• Threshold Score.
The MACRA uses the term “Eligible APM” in the heading for section 1833(z) of the Act, in section 1848(q)(9)(A)(ii) of the Act, and indirectly defines it at section 1833(z)(3)(D) of the Act as the APM in which “eligible alternative payment entities” participate. We have decided to use the term “Advanced” in lieu of “Eligible,” for those APMs defined by section 1833(z)(3)(C) of the Act that meet the criteria under section 1833(z)(3)(D) of the Act. Rather than referring indirectly, as is done in section 1833(z)(3)(D)(i) of the Act, to the APM in which an eligible alternative payment entity participates, we believe it is essential to the understanding of this final rule with comment period to be able to identify and finalize requirements directly for an Advanced APM.
Similarly, we proposed to use the term “Advanced APM Entity” instead of “alternative payment entity” because it highlights the connected but different roles of the Advanced APM (for example, a CMS Innovation Center ACO model meeting specified criteria) and the Advanced APM Entity (for example, a specific ACO participating in that ACO model). We also believed that it was important to the clarity of the proposed rule to define “APM Entity” in addition to “Advanced APM Entity” so that we can easily distinguish between the two under both MIPS and the APM incentives. We proposed that an APM Entity is an entity that participates in an APM or Other Payer APM through a direct agreement with CMS or a non-Medicare other payer, respectively. These APM Entities will be primarily responsible for the cost and quality of care provided to beneficiaries through the APM. The term “eligible alternative payment entity” (which we refer to as an “Advanced APM Entity”) is defined under section 1833(z)(3)(D) of the Act. We proposed that an Advanced APM Entity is an APM Entity that participates in an Advanced APM that, through terms of a direct agreement with CMS or through federal law or regulation, meets the criteria finalized in this rule.
The following is a summary of the comments we received regarding our proposed definitions of the terms APM Entity and Advanced APM Entity.
We are modifying our proposed definition of APM Entity to no longer require a direct agreement with CMS in all cases. Instead, we are defining APM Entity to mean an entity that participates in an APM or payment arrangement with CMS or another payer, respectively, through a direct agreement with CMS or the other payer, or through federal or state law or regulation. We are also finalizing the definition of Advanced APM Entity to mean an APM Entity that participates in an Advanced APM or Other Payer Advanced APM with CMS or a non-Medicare other payer, respectively, through a direct agreement with CMS or
These changes are important because some APMs define participation through a voluntarily signed agreement whereas other APMs may define participation through rulemaking or based on federal or state statutory requirements. For example, the CJR model defines participant hospitals (the APM Entities) in regulation based on their geographic location in specified Metropolitan Statistical Areas (MSAs). These definitions ensure that entities participating in APMs and Advanced APMs by various binding legal means are included in the definitions of APM Entity and Advanced APM Entity, respectively.
We also proposed to define the terms “Medical Home Model” and “Medicaid Medical Home Model” as subsets of APMs and Other Payer APMs, respectively. The MACRA does not define “medical homes” but sections 1848(q)(5)(C)(i), 1833(z)(2)(B)(iii)(II)(cc)(BB), 1833(z)(2)(C)(iii)(II)(cc)(BB), and 1833(z)(3)(D)(ii)(II) of the Act make medical homes an instrumental piece of the law.
We note that medical homes would be the APM Entities in an APM, not the APM itself. The requirements in the MACRA and in this final rule with comment period actually relate to the disposition of the APM, not the participating APM Entities. For instance, as described in section II.F.4.b.(6) of this final rule with comment period, section 1115A(c) of the Act relates to the expansion of models (APMs), not the participants (APM Entities) of such models. APM participants are not expanded under section 1115A(c) of the Act. Therefore, we discuss medical homes in terms of the Medical Home Model, which is the concept to which the MACRA and this final rule with comment period actually refer. Although the definitions are identical but for their payer context, we distinguish Medicaid Medical Home Models because there are specific requirements for them under the determination of Other Payer Advanced APMs as described in section II.F.7.b.(3) of this final rule with comment period.
We proposed that a Medical Home Model must have the following elements:
• Model participants include primary care practices or multispecialty practices that include primary care physicians and practitioners and offer primary care services.
• Empanelment of each patient to a primary clinician.
In addition to these elements, we proposed that a Medical Home Model must have at least four of the following elements:
• Planned coordination of chronic and preventive care.
• Patient access and continuity of care.
• Risk-stratified care management.
• Coordination of care across the medical neighborhood.
• Patient and caregiver engagement.
• Shared decision-making.
• Payment arrangements in addition to, or substituting for, FFS payments (for example, shared savings or population-based payments).
The two required elements are consistent with the fundamental characteristics of medical homes in the various incarnations and accreditation standards across the health care market. Therefore, we believe that an APM cannot be a Medical Home Model unless it has a primary care focus with an explicit relationship between patients and their practitioners. To determine that an APM has a primary care focus, we proposed that the Medical Home Model will have to involve specific design elements related to eligible clinicians practicing under one or more of the following Physician Specialty Codes: 01 General Practice; 08 Family Medicine; 11 Internal Medicine; 37 Pediatric Medicine; 38 Geriatric Medicine; 50 Nurse Practitioner; 89 Clinical Nurse Specialist; and 97 Physician Assistant. We solicited comment on whether this proposal for determining that an APM has a primary care focus is sufficiently specified.
We believe the optional elements should be present in Medical Home Models, but individually, each is less definitive of a characteristic than the two required elements. We also want to adhere to our principle of supporting future flexibility of APM design. Extensive rigid Medical Home Model criteria would not serve the purpose of promoting the development of new and potentially better ways of managing patient care through primary care.
We solicited comment on these elements and which of the elements should be required as opposed to optional. Our proposed definition of Medicaid Medical Home Model is identical to Medical Home Model, except that it specifically describes a payment arrangement operated by a State under title XIX. It is important to separate the terms because Medicaid Medical Home Models have distinct implications in the Other Payer Advanced APM determination and the QP determination under the All-Payer Combination Option.
The following is a summary of the comments we received regarding our proposed definitions of the terms Medical Home Model and Medicaid Medical Home Model.
In addition, the commenter expressed concern with our proposal to include certain eligible clinicians within Medical Home Models, as they are not always primary care practitioners, that is, 50 Nurse Practitioner; 89 Clinical Nurse Specialist; and 97 Physician Assistant. One commenter wanted more information on the licensing description for each category of eligible clinician and more information on the list of physician specialty codes. Another commenter sought clarification on whether or not the code for Nurse Practitioners includes all Nurse Practitioner codes or if the APM should specify codes for certain primary care certifications, and another commenter recommended that codes for family nurse practitioners, geriatric nurse practitioners, adult nurse practitioners, and others be included. A few other commenters recommended that CMS add code “16 Obstetrics and Gynecology” to the list of specialties that we would use to determine a primary care focus in a Medical Home Model. One commenter requested that occupational therapists to be considered a required component of any Medical Home Model. Another commenter suggested that behavioral health organizations be included in the definition of Medical Home Model. Some commenters requested clarification regarding the definition of “parent organization” and “empanelment” as it relates to Medical Home Models.
A few commenters recommended CMS to broaden its definition of a Medical Home Model to include APMs that focus on specialty care. Another commenter suggested CMS to include specialist-focused Medical Home Models as a viable option for qualifying as an Advanced APM regardless of risk, much like it proposed for primary care-focused Medical Home Models. One commenter appreciated that CMS provided for elements such as continuity of care, coordination of chronic and preventive care, and coordination across the medical neighborhood, which will assist multispecialty practices when seeking to participate in an Advanced APM, but believed the definition we proposed for a Medical Home Model would largely exclude specialty-focused models. An additional commenter requested CMS to consider adding additional specialties to the approved list of Physician Specialty Codes to whom the patient may be assigned within the Medical Home Model. Another commenter expressed concern that Medicaid Medical Home Models might be prohibited from empaneling patients to any specialists, and one other commenter suggested that we add to the definition of Medical Home Models as a requirement the attribution of patients to specialists. One commenter suggested we address the special needs of children as a requirement in our definition. Another commenter requested information clarifying the relationship between the Medical Home Model definition and certified patient-centered medical home, and asked whether patient-centered medical home certification is a requirement to be considered a Medical Home Model.
We clarify that the definition of Medical Home Model does not include a requirement for patient-centered medical home certification. A certified patient-centered medical home is a practice-level designation, whereas a Medical Home Model is a type of APM (a payment model) defined in this final rule with comment period.
We believe that empanelment is a commonly understood term used in existing APMs and primary care practices that does not need to be defined in this rulemaking. We believe that empanelment methodologies are specific to each Medical Home Model, and we do not want to unduly restrict APM design flexibility by prescribing how and to whom empanelment may be done. Although we note that Medical Home Models must have a primary care focus, we do not specify that empanelment in a Medical Home Model must be only to primary care practitioners. Finally, we discuss the meaning of “parent organization” in section II.F.4.b.(4) of this final rule with comment period in the context of the Advanced APM financial risk criterion.
We are finalizing the definitions of Medical Home Model and Medicaid Medical Home Model with modifications to emphasize the requirement that the APM have a primary care focus, clarify the required versus additional elements, and add Obstetrics and Gynecology (specialty code 16) as a primary care specialty. We are finalizing the definitions as follows:
A Medical Home Model or Medicaid Medical Home Model is an APM or payment arrangement under title XIX, respectively that we determine to have the following required elements:
• Primary care focus with participants that include primary care practices or multispecialty practices that include primary care physicians and practitioners and offer primary care services. For the purposes of this provision, primary care focus means involving specific design elements related to eligible clinicians practicing under one or more of the following Physician Specialty Codes: 01 General Practice; 08 Family Medicine; 11 Internal Medicine; 16 Obstetrics and Gynecology; 37 Pediatric Medicine; 38 Geriatric Medicine; 50 Nurse Practitioner; 89 Clinical Nurse Specialist; and 97 Physician Assistant.
• Empanelment of each patient to a primary clinician.
In addition to these required elements, a Medical Home Model or Medicaid Medical Home Model must have at least four of the following additional elements:
• Planned coordination of chronic and preventive care.
• Patient access and continuity of care.
• Risk-stratified care management.
• Coordination of care across the medical neighborhood.
• Patient and caregiver engagement.
• Shared decision-making.
• Payment arrangements in addition to, or substituting for, FFS payments (for example, shared savings, population-based payments).
We believe that the proposed terms and definitions are sufficient to clearly implement the Quality Payment Program. These terms cover all steps of the APM Incentive Payment process, from participation in Advanced APMs to QP determinations and payment of incentives. We are aware that this is a complex program and that we propose to define a significant number of terms. We believe that, in general, it is preferable to use more, distinctive terms than to use fewer broader terms that could overlap and convey different meanings in different contexts. For instance, Partial QP Patient Count Threshold is a highly specific term, but we believe that it is necessary in context because there are differences between QPs and Partial QPs, and there are differences between the payment amount and patient count thresholds used to determine whether an eligible clinician becomes a QP or a Partial QP.
We sought comment on these terms, including our proposed definitions, the relationship between terms, any additional terms that we should formally define to clarify the explanation and implementation of this program, and potential conflicts with other terms used by CMS in similar contexts. We also sought comment on the naming of the terms and whether there are ways to name or describe their relationships to one another that make the definitions more distinct and easier to understand. For instance, we wanted to know if commenters believe there are more intuitive or efficient terms than those proposed that would still adhere to the statutory language and the intended purposes of the terms. In particular, we indicated that we would consider options for a framework of definitions that might more intuitively distinguish between APMs and Other Payer APMs and between APMs and Advanced APMs.
We also sought comment on alternative terms or definitions that could be useful in the calculations described in the proposed regulations in §§ 414.1430, 414.1435, 414.1440, and 414.1445 of this final rule with comment period and easily understood by stakeholders.
Therefore, any of those eligible clinicians who participate in Advanced APMs can become QPs for a year and receive the associated APM Incentive Payment. Each APM has its own focus, and many offer opportunities for non-physician practitioners to be participants. Although altering the design of existing or future APMs is beyond the scope of this final rule with comment, we welcome ideas on how to further engage underrepresented clinicians as we work hard to develop more APM opportunities. Finally, we do not believe it would be appropriate to waive the Advanced APM CEHRT requirement for APM Entities that may comprise non-physician practitioners. We believe it is also important to note that, as described in full in section II.F.4.b.(1) of this final rule with comment period, the Advanced APM criteria describe requirements that apply within APMs, but not necessarily to all APM Entities or eligible clinicians in the APM. Under the finalized policy in section II.F.4.b.(1), an APM does not necessarily have to specify that all non-physician practitioners use CEHRT in order to be an Advanced APM.
We are finalizing the definition of “eligible clinician” as proposed. Eligible clinician has the meaning of the term “eligible professional” as defined in section 1848(k)(3) of the Act, is
We received no comments in response to our other proposed terms and definitions.
We are finalizing all other definitions listed in this section as proposed.
This section defines and outlines the proposed criteria for Advanced APMs, APMs through which eligible clinicians would have the opportunity to become QPs as specified in section 1833(z)(3)(C) and (D) of the Act. Other Payer Advanced APMs, types of alternative payment arrangements related to the All-Payer Combination Option, are addressed in section II.F.7. of this final rule with comment period.
An Advanced APM must, by statute, meet certain requirements, and we are finalizing policies for these requirements within this section. First, the broad category of APMs is defined at section 1833(z)(3)(C) of the Act, which states that an APM is any of the following: (i) A model under section 1115A (other than a health care innovation award); (ii) the Shared Savings Program under section 1899; (iii) a demonstration under section 1866C; or (iv) a demonstration required by federal law.
We believed it was necessary to propose additional clarification around the requirements as defined in section 1833(z)(3)(C)(iv) of the Act given the broad scope of programs and demonstrations required by federal legislation that are administered by the Department. We proposed that in order to be an APM as a “demonstration required by Federal law,” the demonstration must meet the following 3 criteria: (1) The demonstration must be compulsory under the statute, not just a provision of statute that gives the agency authority, but one that requires the agency to undertake a demonstration; (2) there must be some “demonstration” thesis that is being evaluated; and (3) the demonstration must require that there are entities participating in the demonstration under an agreement with CMS or under a statute or regulation. We solicited comments on our proposal for these criteria defining a demonstration required under federal law.
We received no comments regarding our proposal that these three criteria must be satisfied in order for a demonstration to be considered an APM as a “demonstration required by Federal law.”
We are finalizing our proposal that an APM that is considered a demonstration required by Federal law is one that meets the following 3 criteria: (1) The demonstration must be compulsory under the statute, not just a provision of statute that gives the agency authority, but one that requires the agency to undertake a demonstration; (2) there must be some “demonstration” thesis that is being evaluated; and (3) the demonstration must require that there are entities participating in the demonstration under an agreement with CMS or under a statute or regulation.
Second, to be considered an Advanced APM, an APM must meet all three of the following criteria, as required under section 1833(z)(3)(D) of the Act. The criteria are:
• The APM must require participants to use CEHRT;
• The APM must provide for payment for covered professional services based on quality measures comparable to those in the quality performance category under MIPS;
• The APM must either require that participating APM Entities bear risk for monetary losses of a more than nominal amount under the APM, or be a Medical Home Model expanded under section 1115A(c) of the Act. For a discussion of Medical Home Models under this criterion, see section II.F.4.b.(6) of this final rule with comment period.
In some cases, APMs offer multiple options or tracks with variations in the level of financial risk, or multiple tracks designed for different types of organizations, and we proposed to assess the eligibility of each such track or option within the APM independently. For instance, the Shared Savings Program has three distinct tracks, the Comprehensive ESRD Care Initiative (CEC) consists of a two-sided track for large dialysis organizations and a one-sided track for non-large dialysis organizations with the option for non-large dialysis organizations to elect to participate in the two-sided risk track beginning in 2017, and the Next Generation ACO Model has two risk arrangement options that feature different levels of financial risk.
Significant distinctions between the design of different tracks or options may mean that some tracks or options within an APM would meet the Advanced APM criteria while other tracks or options would not. For example, APM Entities may have the option to assume two-sided risk (meaning that they bear a portion of the losses when spending exceeds expectations and share in the savings when spending is below expectations) or one-sided risk (meaning that they share in the savings when spending is below expectations, but do not bear a portion of the losses when spending exceeds expectations) under an APM. If the one-sided risk track does not meet the standard for financial risk as discussed in section II.F.4.b.(3) of this final rule with comment period, APM Entities in this track would not be Advanced APM Entities, whereas those in the two-sided risk track could be Advanced APM Entities. In these instances, we would distinguish that the APM is only an Advanced APM for specific options or tracks.
The following is a summary of the comments we received regarding our proposal to make Advanced APM determinations for each individual track or option within in APM when applicable.
We are finalizing the proposal to consider different tracks or options within an APM separately for purposes of making Advanced APM determinations. All entities participating in Advanced APMs are Advanced APM Entities, and distinguishing between the model and the participating entities allows us to directly identify and discuss the requirements unique to each. This approach to identifying Advanced APMs and Advanced APM Entities is also consistent with our finalized proposals for determining QPs, described in section II.F.5. of this final rule with comment period, at the Advanced APM Entity level.
To determine Advanced APMs and to support transparency for the Quality Payment Program, we proposed to establish a process by which we identify and notify the public of the APMs (including specific APM tracks or options) that would be considered Advanced APMs for a QP Performance Period. We indicated that we would post an initial notification to our Web site prior to the beginning of the first QP Performance Period and update the information on a rolling basis as explained below. We believed that making this information available in a timely and accessible format is
We proposed two phases of Advanced APM determinations and notice. First, we proposed to release an initial set of Advanced APM determinations no later than January 1, 2017, for APMs that will be operating during the first QP Performance Period. Second, for new APMs announced after January 1, 2017, we would include its Advanced APM determination in conjunction with the first public notice of the APM, such as the Request for Applications (RFA) or final rule. In preliminary discussions of potential APMs, such as proposed rules, we will provide a non-binding determination based on the proposed APM design. We proposed that determinations of Advanced APMs would be posted on our Web site and updated on an ad hoc basis to the extent feasible, but no less frequently than annually, as new APMs become available and others end or change. Both the initial and ad hoc notifications would contain descriptions of whether each track or option within an APM would have in different Advanced APM statuses. We believe that this proposal incorporates both the interest in immediate dissemination of Advanced APM determinations for the existing APM portfolio following finalization of this rule and the structure for making the Advanced APM status a regular part of the development and release of new APMs in the future.
We solicited comment on the proposals for both the initial and ad hoc notices of Advanced APM determinations. In particular, we solicited comments on optimal times, locations, formats, and other methods of notice of Advanced APM determinations to promote clarity and consistency as to which APMs are considered Advanced APMs for a particular QP Performance Period.
The following is a summary of the comments we received regarding our proposed process to make and notify the public of Advanced APM determinations.
However, we do not find it practical or meaningful to hold a public comment process regarding each Advanced APM determination. These determinations will be factual applications of the Advanced APM criteria, as prescribed by statute and established in this final rule, to the design of a particular APM. The opportunities for meaningful input are in the development of the criteria and the APMs, but not in the administrative task of determining whether the APM meets the Advanced APM criteria. Soliciting input on Advanced APM determinations for individual models could also significantly delay when stakeholders would know whether an APM is an Advanced APM.
We understand the difficulties of a notice and comment rulemaking process when eligible clinicians and entities are trying to make business decisions that can be impacted by policy decisions in a final rule. The proposed rule offered our early thoughts as to which APMs might be considered Advanced APMs in 2017. We encourage stakeholders keep in mind that the designs of APMs themselves offer substantial rewards, and we believe that those design elements should be the primary considerations for eligible clinicians and entities in deciding whether or not to participate in a given APM. Also, in sections II.F.1. and II.F.10. of this final rule with comment period we discuss how we plan to increase the number of Advanced APM opportunities each year.
Some concerns expressed by commenters about Advanced APM determinations are closely linked with our policies on the QP Performance Period and the MIPS performance period, and the interaction between these policies. We encourage commenters to see the discussion of the QP Performance Period in section II.F.5.a. of this final rule with comment period, which describes the operational relationships that address the need to make QP determinations in time for their exclusion from MIPS.
We are finalizing the process for determining Advanced APMs and notifying the public of those determinations as proposed. We will release an initial set of Advanced APM determinations as soon as possible but no later than January 1, 2017. For new APMs that are announced after the release of our initial set of Advanced APM determinations, we will include Advanced APM determinations in conjunction with the first public notice of the APM, such as the Request for Applications (RFA) or final rule. Likewise, if we make changes to an APM that change the determination of whether the APM is an Advanced APM, we will include public notice with the announcement. All determinations of Advanced APMs will be posted on our Web site and updated on an ad hoc basis, but no less frequently than annually, as new APMs become available and others end or change. Both the initial and ad hoc determinations will include descriptions of whether each track or option within an APM is or is not an Advanced APM.
In section II.F.7. of this final rule with comment period, we finalize how we would identify Other Payer Advanced APMs. The Other Payer Advanced APM identification process goes into effect starting in the third QP Performance Period (applicable for payment year 2021) and aligns with the availability of the All-Payer Combination Option for QP determinations.
Under the statute, for an APM to be an Advanced APM it must meet the criteria set forth in sections 1833(z)(3)(C) and (D) of the Act and discussed below. An Advanced APM must be an APM that:
• Requires its participants to use certified EHR technology (CEHRT), as described in section II.F.4.b.(1) of this final rule with comment period;
• Provides for payment for covered professional services based on quality measures comparable to measures under the quality performance category under MIPS, as described in section II.F.4.b.(2) of this final rule with comment period; and
• Either (a) requires its participating Advanced APM Entities to bear financial risk for monetary losses that are in excess of a nominal amount, as described in section II.F.4.b.(3) of this final rule with comment period, or (b) is a Medical Home Model expanded under section 1115A(c) of the Act, as described in section II.F.4.b.(4) of this final rule with comment period.
These requirements as set forth in the statute and as proposed must be met through the design of the APM. Whether an APM is an Advanced APM depends solely upon how the APM is designed, rather than on assessments of participant performance within the APM. Some stakeholders have suggested that actual performance (for example, on CQMs or on whether the Advanced APM Entity generates savings) be considered in the determination of QPs. However, the incentives for Advanced APM participation, as specified under section 1833(z) of the Act, do not provide for consideration of actual performance in making such determinations. Performance assessments are already part of APMs, and we believe it is important and consistent with the statutory framework to continue to foster flexibility in structuring the specific rewards and consequences of performance within each APM.
For example, an APM that ties payments to performance on quality measures comparable to those under MIPS may be an Advanced APM regardless of an Advanced APM Entity's actual performance on those quality measures. If an Advanced APM Entity fails to meet quality performance standards under the Advanced APM, it would face consequences within the Advanced APM, such as financial penalties, loss of access to data or certain waivers, or termination of its participation agreement. The termination scenario would have the downstream effect of terminating Advanced APM Entity status and the eligible clinicians' potential eligibility for the APM Incentive Payment because the entity would no longer be participating in the Advanced APM. As another example, an Advanced APM Entity that bears more than nominal financial risk for monetary losses in accordance with the standards set forth in section II.F.4.b.(3) of this final rule with comment period would be an Advanced APM Entity regardless of whether it actually earns savings or generates losses under the Advanced APM. This would work similarly for an Other Payer Advanced APM.
We do not intend to add additional performance assessments on top of existing Advanced APM standards. As stated in the discussion of policy principles at the beginning of section II.F.1. of this final rule with comment period, the proposed QP determination process assesses the relative degree of participation of the Advanced APM Entity and eligible clinician in Advanced APMs, not their performance as assessed under the APM. The Quality Payment Program would not alter how each particular APM measures and rewards success within its design. Rather, the APM incentive track of the Quality Payment Program rewards a substantial degree of participation in Advanced APMs.
The following is a summary of the comments we received generally regarding our Advanced APM criteria proposals.
Regarding the stringency of the criteria, we agree with some of the concerns raised by commenters. In particular, we agree in that the magnitude of the proposed requirements for the financial risk criterion was too
Finally, it is important for commenters and stakeholders to keep in mind that no eligible clinicians or APM Entities are directly subject to these Advanced APM criteria. These are standards used to determine which APMs are Advanced APMs. The APM designs contain the terms under which APM Entities participate, and many Advanced APMs will have requirements that far exceed the Advanced APM criteria set in this final rule. Changing the Advanced APM criteria will not affect the requirements for participants in any particular Advanced APM.
Some commenters were supportive of the Advanced APM framework but expressed support for additional criteria for determining Advanced APMs, such as demonstrating that the payment approach will reinforce the delivery of coordinated patient- and family-centered care; requiring a clinical care model that reinforces a strong primary care foundation; a focus on care coordination; shared care planning; health IT infrastructure development; population health management; risk management; emphasis on consumer experience; and several more. One commenter suggested that we remove the Advanced APM designation from Advanced APMs that fail to demonstrate successful outcomes.
The first criterion an APM must meet to be considered an Advanced APM is that it requires participants in the APM to use certified EHR technology (as defined in section 1848(o)(4) of the Act), as specified in section 1833(z)(3)(D)(i)(I) of the Act.
For this Advanced APM criterion, we proposed to adopt the definition of CEHRT proposed for MIPS under § 414.1305. In the 2015 EHR Incentive Programs final rule (80 FR 62872 through 62873), we established the definition of CEHRT that must be used by EPs to meet the Meaningful Use objectives and measures in specific years. This definition is similar to the definition that applies to eligible hospitals, CAHs, and EPs in the Medicare EHR Incentive Programs. The definition includes the certification criteria for a wide range of standards for use in capturing patient health information like vital signs, medications and medication allergies, problem list, and lab results among other data elements included in the common clinical data set (CCDS). It also includes the certification criteria and standards for functions related to information exchange, patient engagement, quality reporting, and protecting the privacy of electronic protected health information. For further information on the certification criteria, see the 2015 Edition Certification Criteria final rule (80 FR 62602 through 62759) and for example Table 8: “Common Clinical Data Set” (80 FR 62696).
This approach aligns the APM health IT certification requirements for Advanced APMs with those used by MIPS eligible clinicians. We understand this proposed CEHRT definition may include some EHR functionality used by MIPS eligible clinicians which may be less relevant for an APM participant, and likewise APM participants may use additional functions that are not required for MIPS participation. However, we observe that APM participants often work in the same office space, group, entity, or organization with eligible clinicians that are not APM participants. At times they might share common resources, such as the same EHR system. Using the same CEHRT definition for both MIPS and Advanced APMs would allow eligible clinicians to continue to use shared EHR systems and give eligible clinicians flexibility of participation as a MIPS eligible clinician or an eligible clinician in an Advanced APM without needing to change or upgrade EHR systems. Although updates to the certified health IT for APM participants, MIPS participants, or both may be necessary in future years, we believe that aligning the APM and MIPS definition for CEHRT is appropriate at this time.
We solicited comment on the proposed definition of CEHRT for Advanced APMs.
The following is a summary of the comments we received regarding our proposal to adopt the same definition of CEHRT for Advanced APMs as proposed for MIPS.
The CEHRT definition merely sets the baseline requirements that eligible clinicians must have to meet the meaningful use objectives and measures, which are designed to be applicable for a wide range of clinician types in a diverse range of settings. These requirements are not intended to limit clinicians electing to use more advanced functions or to use health IT in other ways. Rather, the CEHRT definition is intended to ensure that a user has the tools needed to succeed in meeting the objectives and measures, without creating additional burden to obtain health IT unrelated to their practice. As stated in the proposed rule at 81 FR 28299, we intend to maintain continuity for APM participants with the definition recently finalized for the eligible clinicians participating in the MIPS advancing care information performance category, described at § 414.1305. This is also consistent with the EHR Incentive Program's CEHRT definition at 42 CFR 495.4. Therefore, we are finalizing the same definition of CEHRT under the Advanced APM CEHRT use criterion as we have finalized for MIPS at § 414.1305. We will consider whether to include the care plan and other potentially new or advanced certified health IT modules in future rulemaking.
We are finalizing the definition of CEHRT for Advanced APMs as proposed. We believe the CEHRT definition for Advanced APMs aligns the APM health IT certification requirements for Advanced APMs with those used by MIPS eligible clinicians and will permit eligible clinicians using shared systems to participate in both programs without requiring changes to their health IT systems.
The statute does not specify the number of eligible clinicians who must use CEHRT or how CEHRT must be used in an Advanced APM. We believe we have discretion to define the ways in which an Advanced APM requires the use of CEHRT. In accordance with section 1833(z)(3)(D)(i)(I) of the Act, we proposed that an Advanced APM must require at least 50 percent of eligible clinicians (or each hospital if hospitals are the APM participants) to use the certified health IT functions outlined in the proposed definition of CEHRT to document and communicate clinical care with patients and other health care professionals. Communicating clinical care means that other eligible clinicians and/or the patient can view the clinical care information. We also proposed an alternative set of criteria that would be applicable to the Shared Savings Program to demonstrate the use of CEHRT by eligible clinicians participating in ACOs to allow the Shared Savings Program to be an Advanced APM, as discussed further below. We proposed the 50 percent CEHRT use threshold would be confined to the first QP Performance Period (proposed to be 2017, as discussed later in this final rule with comment period). That is, only in 2017 could APMs use the 50 percent threshold for eligible clinicians in each participating entity to meet the use of CEHRT requirement. We proposed that the threshold requirement for use of CEHRT would increase to 75 percent beginning for the second QP Performance Period (proposed to be 2018). The CEHRT requirement for Advanced APMs in which hospitals are the participants would remain the same over time because it is an all-or-nothing requirement of the hospital as a single entity.
We believe there are a few reasons why having a lower threshold requirement for the use of CEHRT by the eligible clinicians participating in an APM Entity in the first year is appropriate. First, we wanted to ensure that APMs have sufficient time to alter their terms and conditions to meet this standard. We also acknowledge that eligible clinicians would be expected to upgrade from technology certified to the 2014 Edition to technology certified to the 2015 Edition for use in 2018, and some eligible clinicians who have not yet adopted CEHRT may wish to delay acquiring CEHRT products until a 2015 Edition certified product is available.
This CEHRT requirement would be based on the requirements that an APM places on its participating APM Entities. In determining whether an APM meets this criterion, we did not propose to assess the level of use of each APM Entity or individual eligible clinician participating in the APM but rather whether the APM requirements meet the standard set forth in the proposed rule.
We invited comment on whether the proposed thresholds for use of CEHRT for APM Entities that are not hospitals (50 percent for the first QP Performance Period (proposed 2017) and 75 percent for the second QP Performance Period (proposed 2018) and later are appropriate, or if we should consider additional options such as a higher or lower percentage in 2018, or an additional incremental increase for 2019. We also invited comment on whether we should consider higher thresholds for APMs that target eligible clinician populations with higher-than-average adoption of certified health IT, such as eligible clinicians in patient-centered medical homes. Finally, we
The following is a summary of the comments we received regarding the proposed thresholds for use of CEHRT for APM Entities that are not hospitals.
We are finalizing our proposal that an Advanced APM must require at least 50 percent of eligible clinicians in each APM Entity to use the certified health IT functions outlined in the proposed definition of CEHRT to document and communicate clinical care with patients and other health care professionals. However, we are not finalizing our proposal to increase the requirement of Advanced APMs to require 75 percent CEHRT use in the subsequent year. We will maintain the 50 percent CEHRT use requirement for the second performance year and beyond and consider making any potential changes through future rulemaking. If the APM has hospitals as its APM Entities, the APM would need to require the hospitals to use CEHRT in order to be an Advanced APM, and the 50 percent threshold does not apply. We will monitor the level of CEHRT use that is required in current APMs and assess the applicability of this criterion to new APMs. We will continue to consider additional changes to the CEHRT use criterion for Advanced APMs in future rulemaking, particularly considering Other Payer Advanced APMs.
We also proposed an alternative criterion for determining whether an APM meets the CEHRT use requirement, exclusively for the Shared Savings Program. We believe this method is appropriate for the Shared Savings Program because although the Shared Savings Program requires ACOs to encourage and promote the use of enabling technologies (such as EHRs) to coordinate care for assigned beneficiaries, a specific level of CEHRT use is not required for participation in the program. Instead, the Shared Savings Program includes an assessment of EHR use as part of the quality performance standard which directly impacts the amount of shared savings/losses generated by the Shared Savings Program ACO. In contrast to APMs authorized by section 1115A of the Act, we would have to undertake significant rulemaking to adopt an eligibility standard for the Shared Savings Program that is consistent with the criterion for other APMs. Following such rulemaking, we would have to collect additional information from each existing and applying ACO outside the routine application process in the weeks prior to the start of the 2017 performance year. We believed this process could introduce uncertainty and burden for CMS, ACOs, and participating eligible clinicians. Moreover, we stated that we believed that the proposed alternative criterion would build on established Shared Savings Program rules and incentives that directly tie the level of CEHRT use to the ACO's financial reward which in turn has the effect of directly incentivizing ever-increasing levels of CEHRT use among eligible clinicians. We believe that the proposed alternative criterion for the Shared Savings Program is consistent with the goals of the APM incentive and reduces burden and uncertainty for the Shared Savings Program participants. Therefore, because most other APMs can accommodate a new CEHRT use requirement for eligible clinicians without modification to our regulations, we proposed to restrict this method to the Shared Savings Program. We proposed that this alternative would allow the Shared Savings Program to meet the criterion if it holds APM Entities accountable for their eligible clinicians' use of CEHRT by applying a financial penalty or reward based on the degree of CEHRT use (such as the percentage of eligible clinicians that use
We are finalizing this alternative criterion exclusively for the Shared Savings Program as proposed. This alternative criterion would allow the Shared Savings Program to meet the criterion if it holds APM Entities accountable for their eligible clinicians' use of CEHRT by applying a financial penalty or reward based on the degree of CEHRT use.
The Shared Savings Program meets this criterion by tying performance on ACO-11, a quality measure that assesses the meaningful use of EHR technology by certain eligible clinicians in the ACO, to the amount of shared savings earned or shared losses incurred by an ACO. We will use data submitted to us through the MIPS advancing care information performance category for purposes of assessing performance on ACO-11 under all tracks of the Shared Savings Program.
Eligible clinicians who become QPs by participating in an Advanced APM will be exempt from reporting in the advancing care information performance category for purposes of MIPS. However, under § 425.500(c) of our regulations, Shared Savings Program ACOs must submit data on ACO quality performance measures according to the method of submission established by CMS. Thus, certain eligible clinicians, as designated in the specifications of ACO-11, participating in ACOs under all tracks of the Shared Savings Program must report for purposes of the advancing care information performance category according to MIPS specifications, regardless of whether they are excluded from MIPS for the year, in order for the Shared Savings Program to assess the ACO's performance on ACO-11, as required by the Advanced APM CEHRT use criterion. As discussed above, we will establish our final policies with respect to the specifications of ACO-11 in the forthcoming CY 2017 PFS final rule with comment period.
We also note that in the CY 2017 PFS Proposed Rule, we propose certain modifications to the EHR measure under the Shared Savings Program (81 FR 46429 through 46430). We will establish our final policies for the specifications of ACO-11 that will be used to assess ACO performance on this measure in 2017 and subsequent years as finalized in the forthcoming CY 2017 PFS final rule.
In addition to the previous proposals, we were interested in what other health IT functionalities APM participants might need to effectively provide care to their patients and how the use of interoperable health IT can strengthen and encourage higher quality patient care and more effective care coordination across all APMs. Recent research and input from experts, practitioners, and the public have identified priority health IT capabilities that would be important for participants in APMs but are not yet widely available in current health IT systems, such as the ability to manage and track status of referrals and create and maintain electronic shared care plans for team-based care management. More information about this research is available at
We believe that all patients, families, and healthcare professionals should have consistent and timely access to health information in a standardized format that can be securely exchanged between these parties (See HHS August 2013 Statement, “Principles and Strategies for Accelerating Health Information Exchange”). The secure, appropriate exchange of health information can help health care professionals improve quality of care through more robust care coordination, and improve the efficiency of care through access to patient information across settings. Interoperability is a key priority for the healthcare industry. HHS recently received pledges from companies that provide 90 percent of the EHRs used by hospitals nationwide, available at
A growing number of organizations across the country are now focused on facilitating health information exchanges (HIEs) among healthcare professionals at the national, state, and community levels. There were 267 organizations providing HIE services operating in the U.S. in 2014, including community-based organizations, statewide efforts, and other healthcare delivery entities supporting exchange, according to
We solicited comment on how requirements for the use of CEHRT within APMs could evolve to support expanded participation in organizations supporting HIEs. The following are the comments received in response to our request for comment related to advancing participation in HIE through the use of CEHRT in Advanced APMs.
The second criterion for an APM to be an Advanced APM is that it provides for payment for covered professional services based on quality measures comparable to measures under the performance category described in section 1848(q)(2)(B)(i) of the Act, which is the MIPS quality performance category. We interpret this criterion to require the APM to incorporate quality measure results as a factor when determining payment to participants under the terms of the APM.
Our proposed policy for this criterion was informed by our proposed policy for the MIPS quality performance category. Quality measures under the MIPS quality performance category are discussed in section II.E.3.b. of this final rule with comment period. In that section, we discuss our proposal for eligible clinicians to select quality measures from the MIPS measures list for the first MIPS performance period. We indicated that we would publish a list of quality measures annually, through notice and comment rulemaking, from which MIPS eligible clinicians may choose measures for assessment under the MIPS quality performance category. The measures included in the annual list of MIPS measures must adhere to specific criteria that include the following: (1) Measures must have an evidence-based focus if the measures are not endorsed by a consensus-based entity as described in section 1848(q)(2)(D)(v) of the Act; and (2) new measures and the method for developing and selecting such measures, including clinical and other data supporting such measures, must be submitted to a specialty-appropriate, peer-reviewed journal prior to inclusion of the measure in MIPS as described in section 1848(q)(2)(D)(iv) of the Act.
The statute also established priorities for both the quality domains of measures to be developed and the types of measures to be prioritized in the measure development plan, which are located, respectively, at sections 1848(s)(1)(B) and (D) of the Act. The priority measure types include outcome, patient experience, care coordination, and measures of appropriate use of services such as measures of overuse.
We wanted to ensure that APMs have the latitude to base payment on quality measures that meet the goals of the APM and assess the quality of care provided to the population of patients that the APM participants are serving. It is important to note that many APMs include some common measures that are proposed for inclusion in MIPS. For example, many of the quality measures used in the Shared Savings Program and the Next Generation ACO Model are also proposed for inclusion in MIPS.
However, APMs that focus on patients with specific clinical conditions such as end-stage renal disease (ESRD), or on patients undergoing specific surgical procedures, would have valid reasons for including different quality measures than those that target more general populations. Similarly, some APMs may focus on specialist eligible clinicians for whom there may be only a small number of valid and relevant quality measures. Lastly, we cannot predict the specific care goals and payment designs of future PFPMs and other APMs. Consequently, we did not want to impose measure requirements that would prevent us from including quality measures that may be better suited to the specific aims of new innovative APMs.
We proposed that the quality measures on which the Advanced APM bases payment must include at least one of the following types of measures provided that they have an evidence-based focus, and are reliable, and are valid:
(1) Any of the quality measures included on the proposed annual list of MIPS quality measures;
(2) Quality measures that are endorsed by a consensus-based entity;
(3) Quality measures developed under section 1848(s) of the Act;
(4) Quality measures submitted in response to the MIPS Call for Quality Measures under section 1848(q)(2)(D)(ii) of the Act; or
(5) Any other quality measures that CMS determines to have an evidence-based focus and be reliable and valid.
We believe that quality measures that are endorsed by the National Quality
We also proposed to establish an Innovation Center quality measure review process for those measures that are not NQF-endorsed or included on the final MIPS measure list to assess whether the quality measures have an evidence-based focus, and are reliable and valid. For example, the Comprehensive ESRD Care Model includes NQF# 0226 Influenza Immunization for the ESRD Population which is not a measure included for reporting in MIPS but meets the proposed criteria for MIPS-comparable quality measures. We stated that we believe, under the proposed categories, MIPS-comparable quality measures could include measures that are fully developed after being tested in an APM and found to be reliable and valid. Similarly, we indicated that we believe MIPS-comparable quality measures could include QCDR measures provided that the QCDR measures used by the Advanced APM for payment have an evidence-based focus and are reliable and valid.
The statute identifies outcome measures as a priority measure type, and we wanted to encourage the use of outcome measures for quality performance assessment in APMs. Therefore, we proposed that in addition to the general comparable quality measure requirements proposed, an Advanced APM must include at least one outcome measure if an appropriate measure (that is, the measure addresses the specific patient population and is specified for the APM participant setting) is available on the MIPS list of measures for that specific QP Performance Period, determined at the time when the APM is first established. If there is no such measure available on the MIPS list at the time the APM is established, then we would not require an outcome measure be included after APM implementation.
We also noted that under the statute and in this proposal, not all quality measures under which an APM is assessed are required to be “comparable” and not all payments under the APM must be based on comparable measures. However, at least some payments must be tied to measures comparable to MIPS, regardless of whether those comparable measures are the only ones the APM uses. Under this proposal, APMs retain sufficient freedom to innovate in paying for services and measuring quality. For instance, an APM may have incentive payments related to quality, total cost of care, participation in learning activities, and adoption of health IT. The existence of all of the payments associated with non-quality aspects does not preclude the APM from meeting this Advanced APM criterion. In other words, this criterion only sets standards for payments tied to quality measurement, not other methods of payment. Conversely, an APM may, as current models at the CMS Innovation Center currently do, test new quality measures that do not fall into the MIPS-comparable standard. So long as the APM meets the requirements set forth in this criterion, there is no additional prescription for how the APM tests additional measures that may or may not meet the standards under this criterion.
We indicated that we believe this framework would provide the flexibility needed to ensure APM quality performance metrics meet the APM's goals. We invited comments on whether measures to be considered comparable to MIPS should all be reliable and valid and have an evidenced-based focus.
The following is a summary of the comments we received regarding our proposed Advanced APM quality measures criterion.
The following is a summary of the comments we received regarding our proposal to require that an Advanced APM must include at least one outcome measure if an appropriate measure is available on the MIPS list of measures for that specific QP Performance Period, as determined at the time when the APM is first established.
We are finalizing as proposed that to be an Advanced APM, an APM must base payment on quality measures that are evidence-based, reliable, and valid; and that at least one such measure must be an outcome measure unless there is not an applicable outcome measure on the MIPS quality measure list at the time the APM is developed. The required outcome measure does not have to be one of those on the MIPS quality measure list. We are also finalizing the proposal to establish an internal Innovation Center quality measure review process for measures that are not NQF-endorsed or on the final MIPS measure list in order to assess whether the measures meet these criteria.
The third criterion that an APM must meet to be an Advanced APM is that it must either be a Medical Home Model expanded under section 1115A(c) of the Act as described below, or the APM Entities under the APM must bear financial risk for monetary losses under such APM that are in excess of a nominal amount. We refer to the latter criterion as the “financial risk criterion.” The correlating financial risk criterion for Other Payer Advanced
The financial risk criterion we proposed for Advanced APMs would apply to the design of the APM financial risk arrangement between CMS and the participating APM Entity. If the structure of the arrangement meets the proposed financial risk requirements, then this criterion would be met. This proposal would not impose any additional performance criteria related to bearing financial risk. For example, eligible clinicians under the Advanced APM Entity would not need to bear financial risk under the APM so long as the APM Entity bears that risk. Furthermore, an APM Entity would not need to actually achieve savings or other metrics for success under the APM in order for the APM to meet this criterion.
In describing our proposal, we divided the discussion into two main topics: (1) what it means for an APM Entity to bear financial risk for monetary losses under an APM; and (2) what levels of risk we would consider to be in excess of a nominal amount. In developing our proposed policies we prioritized keeping these standards consistent across different types of APMs, including Other Payer Advanced APMs as described in section II.F.7.b.(6) of this final rule with comment period. We believe that keeping these standards consistent to the extent possible would make it easier for stakeholders, APM Entities, and eligible clinicians to understand the type of financial risk required for an APM to be an Advanced APM. However, we proposed to specify small variations in the requirements to accord with the differing characteristics of certain types of APMs.
We proposed a generally applicable financial risk standard for Advanced APMs and a unique standard that would apply only for Advanced APMs that are identified as Medical Home Models.
First, we proposed that the generally applicable financial risk standard for Advanced APMs would be that an APM must include provisions that, if actual expenditures for which the APM Entity is responsible under the APM exceed expected expenditures during a specified performance period, we can:
• Withhold payment for services to the APM Entity and/or the APM Entity's eligible clinicians;
• Reduce payment rates to the APM Entity and/or the APM Entity's eligible clinicians; or
• Require the APM Entity to owe payment(s) to CMS.
The proposed financial risk standard for Advanced APMs reflected our interpretation of the statutory requirement that Advanced APM Entities must bear financial risk for monetary losses to encompass “losses” that could be incurred through either direct repayments to CMS or reductions in payments for services. The former would cover two-sided risk arrangements such as shared savings initiatives in which an Advanced APM Entity may receive shared savings or be liable for shared losses. The latter would cover a range of alternative methods for linking performance to payment, such as payment withholds subject to successful performance, or discounts in payment rates retrospectively applied at reconciliation similar to those in many episode-based bundled payment models.
We solicited comments on how we could potentially create an objective and meaningful financial risk criterion that would define financial risk for monetary losses differently.
The following is a summary of the comments we received regarding our proposal for the generally applicable Advanced APM financial risk standard.
Some commenters suggested that we increase the rigor of the financial risk standard so that Advanced APM performance is considered in addition to its financial risk design. For instance, an Advanced APM would have to demonstrate that its payment model is driving care delivery improvements for better outcomes and patient experience. They also suggested design changes for APMs such as enhancing consumer protections as APMs expand in scope or allowing sharing savings with beneficiaries.
For suggestions that we add more layers of requirements for an APM to become an Advanced APM, we do not believe that is the purpose of the APM incentive. In particular, as stated in our principles under section II.F.1. of this final rule with comment period, we believe the APM Incentive Payment is a time-limited incentive (with the combination of the favorable fee schedule update and the potential rewards inherent to APMs being the long-term incentives) intended to encourage movement into the most challenging and potentially most rewarding APMs available as defined by the three Advanced APM criteria described in this section. Each APM has many unique characteristics other than those involving CEHRT use, quality measurement, and financial risk, and we believe that it is important to support rather than constrain flexibility in APM design to the extent feasible. Additionally, we assess all of our APMs continuously, and the measurable success of an APM will determine our ability to expand it in the future, not whether the APM is determined to be an Advanced APM. Moreover, the ultimate evaluation of APM success is: (1) Retrospective in nature, so that if Advanced APM status were to hinge on such results, an APM's status would be uncertain until several years after its launch; and (2) distinct from the challenge of participating in a model with CEHRT use requirements, payment based on MIPS-comparable quality measures, and more than nominal financial risk.
Regarding the comments on consumer protections, just as each APM has its own set of requirements and rewards, it also has its own set of program integrity protections, in addition to those for the overall Medicare program, in which we operate rigorous monitoring programs for each APM.
Some commenters similarly suggested that uncompensated care costs be considered financial risk. Other commenters suggested that we use the Medical Home Model financial risk standard for all APMs, such that the Track 1 adjustment to shared savings based on quality scores would be considered financial risk. Another commenter recommended that APMs that do not have downside risk be considered Advanced APMs for the first 2 years of the Quality Payment Program.
One commenter submitted research suggesting that there is limited uptake and performance in ACOs with downside risk in comparison to Track 1 of the Shared Savings Program, and recommended that CMS recognize the shortcomings of the current two-sided ACO risk models and develop a new APM that includes more appropriate levels of risk. One commenter believes the proposed financial risk standard is inconsistent with the statutory intent to encourage proliferation of, and participation in, Advanced APMs. One commenter suggested that the focus of the financial risk standard should be on the motivation of APM participants to reduce costs rather than whether or not they bear financial risk.
Second, although the cited activities and investments may be geared toward success in an APM, we believe the same activities and investments are likely to be aligned with success under any value-based payment system such as MIPS.
Third, business risk is generally a sunk cost that is unrelated to performance-based payment under an APM. No matter how well or poorly an APM Entity performs, those costs are not reduced or increased correspondingly. Therefore, business “risk” is not analogous to performance risk in the APM context because those activities and investments are simply costs that are not incorporated into the financial calculations of an APM. In fact, we believe the placement of any objective monetary standard for how much investment could be considered more than nominal would inherently offer an incentive for excessive or wasteful investment that might be unrelated to performance.
We also believe that maintaining a clear distinction between APMs and Advanced APMs is consistent with the statute, which did not envision that all APMs would meet this standard. We believe that section 1833(z) of the Act recognizes that not all APMs would meet this criterion. We believe the purpose of the APM incentives is to provide a boost for participation in the most challenging APMs, not to provide funding for infrastructure support for participation in any APM. Several APMs such as the ACO Investment Model, Next Generation ACO Model, and CPC+ model have those investment funds built into the APM.
In addition, we have a stated interest in encouraging movement from one-sided risk arrangements to two-sided risk arrangements, that is, for example from Track 1 to Track 2 or 3 of the Shared Savings Program. Designating a Track 1 ACO as an Advanced APM by permitting business risk to meet the financial risk standard would provide no additional incentive for Track 1 ACOs to transition to two-sided risk models.
With respect to uncompensated care, we do not wish to downplay the financial impact of uncompensated care, but we believe that addressing such costs in the context of APMs is beyond the scope of this final rule with comment period. We do not believe that such costs can be considered as financial risk under an APM in any systematic, quantifiable manner. Even more than with business risk, we do not believe uncompensated care can be considered “monetary losses under such alternative payment model” as stated in section 1833(z)(3)(D)(ii)(I) of the Act. Further, we do not believe that an APM Entity that provides uncompensated care and also participates in an APM that does not meet the financial risk criterion should be considered to be participating in an Advanced APM. Losses resulting from the provision of uncompensated care would be unrelated to the performance requirements under the APM.
With respect to the Medical Home Model financial risk standard, we believe that it is important to maintain the distinction between Medical Home Models and other APMs because we believe that Medical Home Models are categorically different than other types of APMs, as supported by specific provisions in the statute enabling unique treatment of Medical Home Models. Also, Medical Home Model participants tend to be smaller in size and have lower Medicare revenues relative to total Medicare spending than other APM Entities, which affects their ability to bear substantial risk, especially in relation to total cost of care. We believe that the meaning of nominal financial risk varies according to context, and that smaller practices participating in Medical Home Models, as a category, experience risk differently than much larger, multispecialty-
Several commenters suggested that we create a new Shared Savings Program track that closely aligns with the finalized Advanced APM nominal amount standard in this final rule so that there is an option for ACOs, particularly ACOs with relatively low revenue or small numbers of participating eligible clinicians, to participate in an Advanced APM without accepting the higher degrees of risk involved in Tracks 2 and 3. Commenters believe this would be an attractive and meaningful middle path between Tracks 1 and 2 and would be a viable on-ramp for assuming greater amounts of risk in the future. Commenters suggested this opportunity should be coupled with the ability for Track 1 ACOs to move into this new “Track 1.5” before the end of their current agreement periods. Another commenter specifically suggested an asymmetrical ACO model with a low marginal risk rate for losses, such as 25-30 percent of shared losses, and a higher marginal risk rate for savings, such as 70-75 percent of shared savings, with no minimum savings rate or minimum loss ratio.
However, we also noted that although a one-sided model could provide incentives for participants to improve quality, it might not be sufficient incentive for participants to improve the efficiency and cost of health care delivery (76 FR 67904 and 80 FR 32759). Therefore, we have used our authority under section 1899(i)(3) of the Act to create two performance-based risk options, Track 2 and Track 3, where ACOs are not only eligible to share in savings, but also must share in losses. We believe performance-based risk options have the advantage of providing more experienced ACOs an opportunity to enter a sharing arrangement that provides greater reward for greater responsibility, and we have designed our policies for the Shared Savings Program to offer a pathway for ACOs to transition from the one-sided model to performance risk-based arrangements. Therefore, we require that ACOs that elect to enter the Shared savings Program under Track 1 can remain in Track 1 for no longer than 2 agreement periods, and must transition to Track 2 or Track 3 for all subsequent agreement periods. We believe this approach increases interest in the Shared Savings Program by providing a gentler on-ramp while maintaining the flexibility for more advanced ACOs to take on greater performance-based risk in return for a greater share of savings immediately upon entering the program.
Many of the program requirements that apply to ACOs in Tracks 1, 2, and 3 are the same but there are some significant differences that encourage progression along the risk continuum. For example, the financial reconciliation methodology was designed so that ACOs that accept performance-based risk under Track 2 or Track 3 have the opportunity to earn a greater share of savings, in exchange for their willingness to accept performance-based risk. Specific differences between the tracks are summarized in the June 2015 final rule at (80 FR 32811 through 32812).
In June 2016, we issued a final rule (81 FR 37950) to incorporate regional FFS expenditures into the methodology for establishing, adjusting, and updating the benchmarks of ACOs that continue their participation in the Shared Savings Program after an initial 3-year agreement period. In an effort to continue to provide a pathway to increasing performance-based risk, the June 2016 final rule also added a participation option to encourage ACOs to transition to performance-based risk arrangements. Specifically, in the June 2016 final rule, we finalized a policy to give ACOs that participate in Track 1 for their first agreement period an additional option when they apply to renew for a second agreement period under a two-sided model (Track 2 or Track 3). If the ACO's renewal request is approved, the ACO may request that its initial participation agreement under Track 1 be extended for an additional year (that is, the ACO would enter a fourth performance year under Track 1). As a result of this deferral, we will also defer rebasing the ACO's benchmark for 1 year. At the end of this fourth performance year under Track 1, the ACO will transition to the selected performance-based risk track for a three-year agreement period. This option became available beginning with the 2017 application cycle.
However, even with this pathway to performance-based risk, we have heard from stakeholders, as exemplified by the comments above, that we should consider offering ACOs an even more gradual transition to performance-based risk. In the June 2016 final rule, we signaled that we are committed to facilitating entry and continued participation in the Shared Savings Program by ACOs with varying levels of experience with accountable care models and differing degrees of readiness to take on performance-based risk, and to encourage ACOs to transition to performance-based risk
Therefore, we are considering using our authority under section 1115A of the Act to develop and test a “Medicare ACO Track 1+ Model” starting for the 2018 performance year. The Track 1+ Model would test a payment model that incorporates more limited downside risk than is currently present in Tracks 2 or 3 of the Shared Savings Program in order to encourage more rapid progression to performance-based risk. In other words, this potential Track 1+ Model is envisioned as an on-ramp to Tracks 2 or 3. The model could be open to Track 1 ACOs that are within their current agreement period, initial applicants to the Shared Savings Program, and Track 1 ACOs renewing their agreement that meet model eligible criteria. The model would be voluntary for organizations currently participating in Track 1 or seeking to participate in the Shared Savings Program. For Track 1 ACOs that have renewed their agreements, the benchmark that would apply under the model could also incorporate a regional benchmark adjustment consistent with the timing and phase-in of the regional benchmark adjustment as outlined in the June 2016 final rule for the Shared Savings Program. We will announce additional information about the Track 1+ Model in the future.
We are finalizing the Advanced APM financial risk standard as proposed. To be an Advanced APM, an APM must provide that, if actual expenditures for which an APM Entity is responsible under the APM exceed expected expenditures during a specified performance period, CMS can:
• Withhold payment for services to the APM Entity and/or the APM Entity's eligible clinicians;
• Reduce payment rates to the APM Entity and/or the APM Entity's eligible clinicians; or
• Require the APM Entity to owe payment(s) to CMS.
We note that this generally applicable financial risk standard does not include reductions in otherwise guaranteed payments made under the terms of the APM—such as care management fees that vary based on quality performance—whereas, as described below, the Medical Home Model financial risk standard does take into consideration reductions in otherwise guaranteed payments under certain circumstances. As such, one-sided risk arrangements would not meet this financial risk criterion.
We proposed to adopt a slightly different financial risk standard for Medical Home Models. For a Medical Home Model to be an Advanced APM, it must include provisions that CMS:
• Withhold payment for services to the APM Entity and/or the APM Entity's eligible clinicians;
• Reduce payment rates to the APM Entity and/or the APM Entity's eligible clinicians;
• Require the APM Entity to owe payment(s) to CMS; or
• Cause the APM Entity to lose the right to all or part of an otherwise guaranteed payment or payments, if either:
++ Actual expenditures for which the APM Entity is responsible under the APM exceed expected expenditures during a specified performance period; or
++ APM Entity performance on specified performance measures does not meet or exceed expected performance on such measures for a specified performance period.
With regard to the proposed financial risk standard for Medical Home Models, we believe that the Medical Home Model is a unique type of APM that is treated differently under both the MIPS and APM programs. For example, under the MIPS clinical practice improvement activity performance category, as described in section II.E.3.f. of this final rule with comment period, eligible clinicians participating in medical homes receive an automatic 100 percent score, whereas eligible clinicians participating in other APM Entities receive a minimum of a 50 percent score. Additionally, Medical Home Models are distinct from other APMs in that, if they are models tested under section 1115A of the Act, there is the possibility of having an alternate pathway to meet the financial risk criterion through expansion under section 1115A(c) of the Act; and the presence of Medicaid Medical Home Models in a state can affect whether Medicaid payments or patients are excluded in the All-Payer Combination Option for QP determinations (see sections 1833(z)(2)(B)(ii)(I)(bb) and (iii)(II)(cc)(BB), 1833(z)(2)(C)(ii)(I)(bb) and (iii)(II)(cc)(BB), 1833(z)(3)(C)(ii)(II), and 1848(q)(5)(C)(i) of the Act). Medical Home Models and their participating APM Entities (medical homes) are different from other APMs and their respective APM Entities in that: (1) Medical homes tend to be smaller in size and have lower Medicare revenues relative to total Medicare spending than other APM Entities, which affects their ability to bear substantial risk, especially in relation to total cost of care; and (2) to date, neither publicly nor commercially-sponsored medical homes have been required to bear the risk of financial loss, which means the assumption of any financial risk presents a new challenge for medical homes. For example, a common group practice in the Comprehensive Primary Care (CPC) initiative may consist of less than 20 individuals, including physicians, non-physician practitioners, and administrative staff. Making large lump sum loss payments or going without regular payment for a substantial period of time could put such practices out of business, whereas large ACOs may comprise an entire integrated delivery system with sufficient financial reserves to weather direct short-term losses.
We therefore believe that the unique characteristics of Medical Home Models warrant the application of a financial risk standard that reflects these differences to provide incentives for participation in the most advanced financial risk arrangements available to medical homes practitioners.
The proposed financial risk standard for Medical Home Models is similar to the generally applicable Advanced APM standard in its first three conditions. The difference is in the inclusion of the fourth condition for the proposed financial risk standard for Medical Home Models, which would allow a performance-based forfeiture of part or all of a payment under an APM to be considered a monetary loss. For example, a Medical Home Model would meet this standard if it conditions the payment of some or all of a regular care management fee to APM Entities upon meeting specified performance standards. Because the APM does not require any direct payment or repayment to us, a medical home penalized in such a manner would not necessarily be in a weaker financial position than it had been prior to the decreased payment; however, it would be in a comparatively worse position in the future than it otherwise would have been had it met performance standards. We believe that this financial risk standard respects the unique challenges of medical homes in bearing risk for losses while maintaining a more rigorous standard than business risk.
We solicited comment on the proposed standards set forth for both Advanced APM Medical Home Models and for all other APMs, including any comments on alternative standards suggested by the public that could achieve our stated goals and the
The following is a summary of the comments we received regarding our proposal for a unique Advanced APM financial risk standard for Medical Home Models.
We disagree with comments stating that the statute supports no financial risk for Medical Home Model participants. Section 1833(z)(3)(D)(ii)(II) of the Act is clear that a Medical Home Model must be actually expanded under section 1115A(c) of the Act to meet the financial risk criterion without requiring APM Entities to bear more than nominal financial for monetary losses. The expanded Medical Home Model aspect of the financial risk criterion is described in full below in section II.F.4.(b) of this final rule with comment period.
We also disagree that our financial risk criterion for Medical Home Models to be Advanced APMs imposes undue risk on clinicians. This financial risk requirement only pertains to how a Medical Home Model must generally be structured in order to be an Advanced APM. There is no requirement that all Medical Home Models be Advanced APMs, and, to date, we have not created any mandatory Medical Home Models. Clinicians receive substantial credit under MIPS in the improvement activities performance category for participation in Medical Home Models or receiving certain certified patient-centered medical home certifications, regardless of whether they participate in an Advanced APM.
In fact, the financial risk policy that we finalize here for Medical Home Models is an exception to the generally applicable rule in recognition that Medical Home Models are categorically different than other types of APMs. However, we do not have the authority to dispense with the statutory requirement that an Advanced APM is one in which participating APM Entities bear more than nominal financial risk for monetary losses unless the APM is a Medical Home Model expanded as permitted under section 1115A(c).
Lastly, we agree with commenters that we should focus on improving APM and Advanced APM participation opportunities for small and rural practices. However, we do not believe that pursuing those goals is mutually exclusive with creating Advanced APM participation opportunities through the Medical Home Model financial risk standard.
We are finalizing the Advanced APM financial risk standard for Medical Home Models as proposed. For a Medical Home Model to be an Advanced APM, it must include provisions such that CMS could:
• Withhold payment for services to the APM Entity and/or the APM Entity's eligible clinicians;
• Reduce payment rates to the APM Entity and/or the APM Entity's eligible clinicians;
• Require the APM Entity to owe payment(s) to CMS; or
• Cause the APM Entity to lose the right to all or part of an otherwise guaranteed payment or payments,
if either:
• Actual expenditures for which the APM Entity is responsible under the APM exceed expected expenditures during a specified performance period; or
• APM Entity performance on specified performance measures does not meet or exceed expected performance on such measures for a specified performance period.
If the APM risk arrangement meets the proposed financial risk standard, we would then consider whether the amount of the risk is in excess of a nominal amount in order for this Advanced APM criterion to be met. We believe the statutory requirement that an APM Entity bear risk under an APM in excess of a nominal amount (which we would term the “nominal amount standard”) relates to a particular quantitative risk value at which we would consider the risk arrangement to involve potential losses of more than a nominal amount. Similar to the financial risk portion of this assessment, we proposed to adopt a generally applicable nominal amount standard for Advanced APMs and a unique nominal amount standard for Medical Home Models. Under the proposed generally applicable nominal amount standard, the total risk percentages are of the APM Entity benchmark or, in the case of episode payment models, the target price, which is the amount of Medicare expenditures (which can vary as to the involvement of Parts A and B depending on the APM) above which an APM Entity owes losses and below which an APM Entity earns savings. In the case of Medical Home Models, the proposed risk percentages for Medical Home Models are based on Medicare Parts A and B revenue. As an alternative, we considered assessing total risk under the generally applicable nominal amount
In general, we believe that the meaning of “nominal” is, as plain language implies, minimal in magnitude. However, in the context of financial risk arrangements, we do not believe it to be a mere formality. For instance, we do not believe the law was intended to consider one dollar of risk to be more than nominal. That would create an arbitrary distinction between an APM that has only upside reward potential and one that has the same upside reward potential with a fractional and relatively meaningless downside risk. Therefore, in arriving at the proposed values, we sought amounts that would be meaningful for the entity but not excessive. As reference points to anchor the proposed values, we used the percentage amounts of MIPS adjustments in the MACRA and surveyed current APM risk arrangements, including those in Tracks 2 and 3 of the Shared Savings Program, the Pioneer ACO Model, and the Bundled Payments for Care Improvement (BPCI) Initiative. We considered the potential losses and marginal risk rates of those initiatives to be optimal in that they have been vetted through the APM development process and determined to be the appropriate amount of risk for each initiative such that, in the context of the APM, it is anticipated that the amount of risk would motivate the desired changes in care patterns to reduce costs and improve quality. As stated previously, we believe that the term “nominal” is clearly an amount that is lower than optimal but substantial enough to drive performance. In other words, we are confident that risk levels in current APMs with downside risk are sufficient for a wide variety of providers and suppliers, but in certain circumstances, we would want to encourage participation in APMs with slightly lower levels of risk, though not levels of risk that are so low that an APM becomes no more effective at motivating desired changes than APMs with no downside risk.
Except for risk arrangements described under section II.F.4.b.(4) of this final rule with comment period, we proposed to measure three dimensions of risk described in this section to determine whether an APM meets the nominal amount standard: (a) Marginal risk, which is a common component of risk arrangements—particularly those that involve shared savings—that refers to the percentage of the amount by which actual expenditures exceed expected expenditures for which an APM Entity would be liable under the APM; (b) minimum loss rate (MLR), which is a percentage by which actual expenditures may exceed expected expenditures without triggering financial risk; and (c) total potential risk, which refers to the maximum potential payment for which an APM Entity could be liable under the APM. Except for risk arrangements described under section II.F.4.b.(3) of this final rule with comment period, we proposed that for an APM to meet the nominal amount standard the specific level of marginal risk must be at least 30 percent of losses in excess of expected expenditures, and a minimum loss rate, to the extent applicable, must be no greater than 4 percent of expected expenditures, and total potential risk must be at least 4 percent of expected expenditures. As described in greater detail in section II.F.7. of this final rule with comment period, the proposed Other Payer Advanced APM nominal amount standard paralleled the proposed standard described here for Advanced APMs. In general, we proposed to define expected expenditures to be the level of expenditures reflected in the APM benchmark. However, for episode payment models, we proposed to define expected expenditures to be the level of expenditures reflected in the target price.
To determine whether an APM satisfies the marginal risk portion of the nominal amount standard, we would examine the payment required under the APM as a percentage of the amount by which actual expenditures exceeded expected expenditures. We proposed that we would require that this percentage exceed the required marginal risk percentage regardless of the amount by which actual expenditures exceeded expected expenditures. APM arrangements with less than 30 percent marginal risk would not meet the nominal amount standard. We believed that meaningful risk arrangements can be designed with marginal risk rates of greater than 30 percent. We believed that any marginal risk below 30 percent could create scenarios in which the total risk could be very high, but the average or likely risk for an APM Entity could actually be very low. We also proposed that the payment required by the APM could be smaller when actual expenditures exceed expected expenditures by enough to trigger a payment greater than or equal to the total risk amount required under the nominal amount standard. This was essentially an exception to the marginal risk requirement so that the standard would not effectively require APMs to incorporate total risk greater than the amount required by the total risk portion of the standard.
We proposed a maximum allowable “minimum loss rate” (MLR) of 4 percent in which the payment required by the APM could be smaller than the nominal amount standard would otherwise require when actual expenditures exceed expected expenditures by less than 4 percent; this exception accommodates APMs that include zero risk with respect to small losses but otherwise satisfy the marginal risk standard. If actual expenditures exceed expected expenditures by an amount exceeding the MLR, then all excess expenditures (including excess expenditures within the MLR) would be subject to the marginal risk requirements. For example, ACOs participating in performance-based risk arrangements under Tracks 2 and 3 of the Shared Savings Program are permitted to choose their own minimum savings rate (MSR) and MLR between zero and 2.0 percent or a variable MSR and MLR up to 3.9 percent based on the number of assigned beneficiaries as long as the MSR and MLR are symmetrical. If losses do not exceed the chosen MLR, the ACO is not held responsible for losses. If the ACO has a very large MLR, there may be little to no risk with respect to losses below a certain percentage of the benchmark. Therefore, we believed it was appropriate to propose a maximum allowable MLR. We
To determine whether an APM satisfies the total risk portion of the nominal amount standard, we would identify the maximum potential loss an APM Entity could be required to incur as a percentage of expected expenditures under the APM. If that percentage exceeded the required total risk percentage, then the APM would satisfy the total risk portion of the nominal amount standard.
In evaluating both the total and marginal risk portions of the nominal amount standard, we would not include any payments the APM Entity or its eligible clinicians would make to us under the APM if actual expenditures exactly matched expected expenditures. In other words, payments made to us outside the risk arrangement related to expenditures would not count toward the nominal amount standard. This requirement ensures that perfunctory or pre-determined payments do not supersede incentives for improving efficiency. For example, an APM that simply requires an APM Entity to make a payment equal to 5 percent of the APM benchmark at the end of the year, regardless of actual expenditure performance, would not satisfy the nominal amount standard.
In particular, the financial risk an Advanced APM Entity would bear under an Advanced APM need not take a shared savings structure in which the financial risk increases smoothly based on the amount by which an Advanced APM Entity's actual expenditures exceed expected expenditures. Examples of a risk arrangement based on shared savings are Tracks 2 and 3 of the Shared Savings Program, where the greater the losses in relation to the expenditure benchmark, the greater the potential amount of shared losses an ACO would be required to repay us. On the other hand, an Advanced APM could require APM Entities to pay a penalty based on expenditure targets, regardless of the degree to which the APM Entity actually exceeded those expenditure targets, provided that the payments are otherwise structured in a way that satisfies both the marginal and total risk requirements under the nominal amount standard.
We solicited comment on appropriate levels for the allowable minimum loss rate and the parameters we should consider when determining whether a risk arrangement should warrant an exception from the minimum loss rate portion of the nominal amount standard.
We solicited comment on the Advanced APM nominal amount standard. In particular, we solicited comment on whether the Advanced APM benchmark or the Advanced APM Entity revenue is a more appropriate basis for assessing total risk and on the proposed amounts of total potential risk, marginal risk, and maximum allowable minimum loss rate. In particular, we solicited comment on whether 30 percent is a sufficient level of marginal risk to be considered “more than nominal.” We also solicited comment on whether there could be a meaningful standard that we could adopt that only includes total and marginal risk without the minimum loss rate component. Finally, we solicited comment on a tiered nominal risk structure in which different levels of marginal risk could be paired with different levels of total risk.
In commenting on possible alternatives, we encouraged commenters to refer to the policy principles articulated in section II.F.1. of this final rule with comment period and to consider the extent to which their proposed alternatives would be more or less consistent with those principles.
The following is a summary of the comments we received regarding our proposal to set the generally applicable nominal amount standard such that, to be an Advanced APM, an APM must have total risk of at least 4 percent of expected expenditures, marginal risk of at least 30 percent, and, if applicable, a minimum loss rate (MLR) of no more than 4 percent, for which we would also have a process to determine whether a higher MLR is appropriate for particular APMs.
Many commenters also believe that the proposed standard's amount of risk was too high because 4 percent of total cost of care could equate to upwards of 20 percent of an entity's revenue depending on the composition of the APM Entity, and discourages all but the most highly-resourced organizations from Advanced APM participation. Some commenters suggested starting at a lower amount of total risk and increasing over time. Many commenters believe that between 1 and 3 percent of Parts A and B revenue would be a reasonable definition of “more than nominal,” particularly in light of not including up-front or investment costs in the determination. Some commenters recommended tailoring risk standards based on various factors or adjusting marginal risk and total risk in relation to one another to the degree that marginal risk could be paired with lower total risk. One commenter stated that level of risk is too high because clinicians would not have access to information on the expenditures outside an APM Entity until the end of a given year. One commenter was concerned that the nominal amount standard would be burdensome for rural practices and potentially reduce access to care in rural settings. Some commenters requested that CMS make the generally applicable nominal risk definition more like that proposed for medical homes.
Finally, many commenters stressed that basing the nominal amount standard on APM Entity revenue, rather than expected expenditures as proposed, would be a more meaningful standard that allows for tailoring risk to the size of APM Entities. Several commenters suggested values of between 2 and 15 percent of eligible clinician or APM Entity revenue would be an appropriate standard. Some commenters noted that this would also make the standard more comparable to MIPS.
Regarding the total risk portion of the proposed standard, we agree with commenters that the meaning of “nominal” can be relative and that for many APM Entities, 4 percent of a total cost of care benchmark could represent a significant fraction of an APM Entity's revenue. We believe such amounts of risk would be more than nominal for all APM Entities, but much more substantial for some APM Entities. We recognize that a revenue-based standard would provide an alternative approach under the nominal amount standard that would be particularly meaningful to practices of certain sizes. However, we caution that a revenue-based standard is not easily applied to most current APMs, which tend to base risk arrangements on expenditure benchmarks that are unrelated to a particular APM Entity's revenue. We believe that total cost of care benchmarks are optimal for many APMs, and those will continue to represent the preferred standard for assessing performance in terms of cost. We also caution that, under a revenue-based standard, certain types of APM Entities may have a significant probability of incurring losses outside the stop loss and thus bear no responsibility for increases in expected expenditures beyond that point, which may undermine the ability of such APMs to drive performance for those APM Entities. In seeking a risk standard that is meaningful but not excessive, we sought to balance these considerations.
In deciding on the policy that we finalize below, we considered several alternatives. For instance, we considered setting the revenue-based standard at up to 15 percent of revenue or setting the revenue-based standard at 10 percent so long as risk is at least equal to 1.5 percent of expected expenditures for which an APM Entity is responsible under an APM. While we are finalizing lower revenue-based standards for the first two QP Performance Periods in 2017 and 2018, we intend to increase the standard to one of the alternatives discussed above for the QP Performance Period in 2019 and later years. We will weigh public comments on this final rule with comment period and assess the impact of this standard, particularly on the design of Other Payer Advanced APMs by non-Medicare payers, in establishing the nominal amount standard for the QP Performance Period in 2019 and later. We particularly seek comments on a standard that tailors the level of risk to particular APM Entities' circumstances while also ensuring that APMs include strong incentives to improve performance and coordinate care across clinician types. In addition, we will consider the amount of risk taken in APM contracts (with Medicare and other payers) and seek comment on trends in those amounts and other factors that may inform the nominal risk standard for 2019.
Finally, although we are finalizing a policy that is responsive to these comments in that we are not finalizing marginal risk components and we are generally reducing the requisite total risk for an APM to be an Advanced APM, we encourage commenters and other stakeholders to understand that, based on our preliminary analysis, all APMs that could be Advanced APMs for 2017 would have higher levels of risk than would be required under the proposed or the finalized standard. We also point out that reducing the standard for what constitutes a more than nominal amount of risk for losses for purposes of deciding whether an APM is an Advanced APM would not reduce the level of risk under any particular APM, nor is it likely to change the list of Advanced APMs in 2017. Rather, it opens the opportunity for future APMs to be considered Advanced APMs with lower levels of risk than those currently identified as potential Advanced APMs. However, as discussed above, we intend that such future APMs will meet the proposed marginal risk and minimum loss rate standards.
We are finalizing two ways that an APM can meet the Advanced APM nominal amount standard. An APM would meet the nominal amount standard if, under the terms of the APM, the total annual amount that an APM Entity potentially owes us or foregoes is equal to at least: (1) For QP Performance Periods in 2017 and 2018, 8 percent of the average estimated total Medicare Parts A and B revenues of participating APM Entities (the “revenue-based standard”); or (2) for all QP Performance Periods, 3 percent of the expected expenditures for which an APM Entity is responsible under the APM (the “benchmark-based standard”). For episode payment models, expected expenditures means the target price for an episode. We note that we are only finalizing the amount of the revenue-based nominal amount standard for the first two QP Performance Periods at this time. However, we intend to increase the revenue-based nominal amount standard for the third and subsequent QP Performance Periods. We seek comment on the amount and structure of the revenue-based nominal amount standard for QP Performance Periods in 2019 and later. Specifically, we seek comment on: (1) Setting the revenue-based standard for 2019 and later at up to 15 percent of revenue; or (2) setting the revenue-based standard at 10 percent so long as risk is at least equal to 1.5 percent of expected expenditures for which an APM Entity is responsible under an APM.
The standard we are finalizing for the 2017 and 2018 QP Performance Periods is a change from the proposed nominal amount standard. Under this final standard, we would not assess marginal risk or MLRs. Additionally, instead of replacing the proposed benchmark-based total risk standard with the revenue-based standard, we are adopting the revenue-based standard as an additional option. Therefore, if an APM's financial design meets either of the two nominal amount standards, we would consider the nominal amount standard to be met. This makes the finalized standard more accommodating of the increasing variety of financial designs in APMs. For instance, current APMs that have total cost of care benchmarks, such as the Next Generation ACO Model, would be easily assessed as to whether they meet the benchmark-based standard because the standard and the APM design use the same metric. Other potential APM designs might be more easily assessed under the revenue-based standard. The nominal amount standard we are finalizing for the 2017 and 2018 QP Performance Periods further increases flexibility because, in the event that an APM using a total cost of care benchmark does not meet the benchmark-based standard, we would still assess it under the revenue-based standard by calculating the total potential risk as a percentage of the average estimated Medicare Parts A and B revenue of the participating APM Entities.
Although we are finalizing a standard based in part on revenue, for episode payment models we believe the standard based on the target price is most relevant, as target price is the focal point for risk under such APMs. Using a revenue-based standard for episode payment models would likely disqualify most potential episode payment models from becoming Advanced APMs because their relatively narrow scope makes the amount at risk a smaller percentage of APM Entity revenue when compared to APMs like ACO initiatives.
As discussed above, our intention in setting a revenue-based nominal amount standard is to tailor the level of risk an APM Entity must bear relative to the resources available to it. In instances where an APM Entity is one component of a larger health care provider organization, we believe that the revenue of the larger organization is a more accurate measure of the resources available to the APM Entity and should be the basis for setting the revenue-based nominal amount standard, even if only a portion of the organization is participating in the APM Entity.
However, we believe that it will not be operationally feasible to apply the nominal amount standard in this fashion during the first two QP Performance Periods, so this final rule sets the revenue-based nominal amount standard based solely on the revenue of the APM Entity. Nevertheless, ideally, the nominal amount standard would take into consideration the resources available to an APM Entity using a measure such as revenue for the parent organization. We are evaluating the feasibility of implementing such a measure in lieu of APM Entity revenue for the third year of the program and later years. Under such an approach, we would anticipate basing the revenue-based nominal amount standard on the total Medicare Parts A and B revenues across the APM Entity, any parent organizations, any subsidiary organizations, and any subsidiaries of parent organizations for all eligible clinicians and groups who are participants of an APM Entity. We seek comment on this approach and how such an approach could be implemented while minimizing burden on participants.
We proposed that for Medical Home Models, the total annual amount that an Advanced APM Entity potentially owes us or foregoes under the Medical Home Model must be at least the following amounts in a given performance year:
• In 2017, 2.5 percent of the APM Entity's total Medicare Parts A and B revenue.
• In 2018, 3 percent of the APM Entity's total Medicare Parts A and B revenue.
• In 2019, 4 percent of the APM Entity's total Medicare Parts A and B revenue.
• In 2020 and later, 5 percent of the APM Entity's total Medicare Parts A and B revenue.
We believe the statute's explicit discussion of medical homes gives us unique latitude to separately set financial risk and nominal amount standards for Medical Home Models that fall below an amount we consider sufficient to be “more than nominal” in the context of other types of APMs. We also believe that the meaning of the term “nominal” depends on the situation in which it is applied, so we believe it is appropriate to consider the characteristics of the APM Entities in Medical Home Models in setting the nominal amount standard for Medical Home Models. As we noted in discussing the financial risk standard, few APM Entities in Medical Home Models have had experience with financial risk, and many would be financially unable to provide sufficient care or even remain a viable business in the event of substantial disruptions in revenue. As such, we believe we should base the nominal amount standard on the APM Entity's total Medicare Parts A and B revenues and also avoid a potentially excessive level of risk for such entities. Our proposal set forth a gradually increasing but achievable long-term amount of risk that would apply in subsequent years. In general, we believe that this scheme allows
Even more than for participants in non-Medical Home Models, basing the Medical Home Model nominal amount standard on percentage of risk in relation to a total cost of care benchmark would mean that participants would be required to bear greater total risk in relation to their revenues than other entities, which we believe would be undesirable in light of the special characteristics of Medical Home Models.
For the Medical Home Model nominal amount standard, we solicited additional comment on the length of the proposed multi-year “ramp up period” and the magnitude of the total risk amounts during such a period. We also solicited comment on the potential addition of a marginal risk amount to the extent applicable and on whether the Advanced APM benchmark or Advanced APM Entity revenue is the most appropriate standard for measuring total risk.
In commenting on possible alternatives, we encouraged commenters to refer to the policy principles articulated in section II.F.1. of this final rule with comment period and to consider the extent to which their proposed alternatives would be more or less consistent with those principles.
The following is a summary of the comments we received regarding our proposal for the Advanced APM nominal amount standard for Medical Home Models.
We also reiterate, as we note for the generally applicable nominal amount standard, that the terms and conditions in the particular APM govern the actual risk that participants experience; the nominal amount standard we are setting in this final rule with comment period merely sets a floor on the level of risk required to be an Advanced APM. Therefore, we do not believe that this nominal amount standard for Medical Home Models will in itself limit Advanced APM participation opportunities. Rather, we believe that developing more APMs, amending existing APMs, expanding successful APMs, and reopening applications for certain APMs could result in increased opportunities to participate in Advanced APMs in the near future.
We are finalizing the Medical Home Model nominal amount standard as proposed.
To be an Advanced APM, a Medical Home Model must require that the total annual amount that an Advanced APM Entity potentially owes us or foregoes under the Medical Home Model be at least the following amounts in a given performance year:
• In 2017, 2.5 percent of the APM Entity's total Medicare Parts A and B revenue.
• In 2018, 3 percent of the APM Entity's total Medicare Parts A and B revenue.
• In 2019, 4 percent of the APM Entity's total Medicare Parts A and B revenue.
• In 2020 and later, 5 percent of the APM Entity's total Medicare Parts A and B revenue.
Also, parallel with the generally applicable nominal amount standard, if the financial risk arrangement under the Medical Home Model is not based on revenue (for example, it is based on total cost of care or a per beneficiary per month dollar amount), we will make a determination for the APM based on the risk under the Medical Home Model compared to the average estimated Parts A and B revenue of its participating APM Entities using the most recently available data.
We believe that, given the unique financial risk and nominal amount standards we proposed for Medical Home Models, it would be appropriate to impose size and composition limits for the Medical Home Models to which the unique standards would apply to ensure that the focus is on organizations with a limited capacity for bearing the same magnitude of financial risk as larger APM Entities do. We proposed that, beginning in the second QP Performance Period (proposed to be 2018), the Medical Home Model financial risk standard and nominal amount standard, described in section II.F.4.b.(4) of this final rule with comment period, would only apply to APM Entities that participate in Medical Home Models and that have 50 or fewer eligible clinicians in the organization through which the APM Entity is owned and operated. Thus, in a Medical Home Model that meets the criteria to be an Advanced APM, the proposed Medical Home Model financial risk and nominal amount standards would only apply to those APM Entities owned and operated by organizations with 50 or fewer eligible clinicians. We believe it is appropriate to use the number of eligible clinicians as the basis, rather than physicians, for this threshold because the number of eligible clinicians reflects organizational resources and capacity, and also may fluctuate widely around a specific number of physicians. We also believe that the size threshold of 50 eligible clinicians is appropriate because organizations of that size have demonstrated the capacity and interest in taking on higher levels of two-sided risk either by themselves or by joining with other organizations. In the event that a Medical Home Model happens to meet the generally applicable financial risk and nominal amount standards, this organizational size limitation would not be applicable. We proposed the same restriction on Medicaid Medical Home Models as discussed in section II.F.7 of this final rule with comment period.
Measuring organizational size based on the size of the “parent organization” differs from measuring it based on the size of the APM Entity. Collecting accurate information on the number of eligible clinicians affiliated with a parent organization would require additional, but we believe achievable, reporting by APM Entities. We believe that size of the organization is generally a better indication of risk-bearing
We proposed to implement this size limitation for Advanced APMs that are Medical Home Models beginning in the second year of the Quality Payment Program (2018 QP Performance Period) because we understand that applications for many APMs would be due to us prior to this final rule, precluding APM Entities from having time to substantially adjust their APM participation strategies for the 2017 QP Performance Period. We proposed that we would make a determination of whether an APM Entity meets the size limitation prospectively before a QP Performance Period, and that the determinations would not subsequently change based on changes in organizational size during or after the QP Performance Period (although changes in organizational size would, as applicable, affect determinations for subsequent QP Performance Periods).
We solicited comment on this proposal, particularly with regard to the use of the count of eligible clinicians in the parent organization of the APM Entity as the metric of organizational size for Medical Home Models, and whether setting the limit at 50 for the number of eligible clinicians in the organization would constitute a reasonable threshold to distinguish between organizations that we could expect to have the financial capability to join APMs, such as ACO initiatives, that have two-sided risk. We also solicited comment on an alternative option to establish the size limitation based on the number of eligible clinicians in the entire Medical Home Model, rather than on number of eligible clinicians in a particular APM Entity's organization.
The following is a summary of the comments we received regarding our proposal to, starting in the second QP Performance Period, restrict the Medical Home Model financial risk and nominal amount standards applicable only to APM Entities with 50 or fewer eligible clinicians in their parent organizations. Comments regarding our proposal to apply the same restriction on Medicaid Medical Home Models are also included.
Some commenters believe that our proposed size criterion of 50 eligible clinicians in the organization is an arbitrary cutoff that does not accurately represent a distinction between organizations that can and cannot reasonably assume downside risk, and some asked for clarification for why the cutoff was set at 50. Some suggested that if we do not eliminate the size limit, we should increase it to 100 or 200 clinicians. Other clinicians suggested that the limit be applied to APM Entities rather than parent organizations.
We also believe that a Medical Home Model such as CPC+ offers many inherent benefits to its participants regardless of the opportunity to earn the APM Incentive Payment. The 5 percent APM Incentive Payment will be one benefit to certain Advanced APM participants, but the opportunities within APMs themselves should be the primary drivers of participation decisions because those risks and rewards within the APMs can outweigh the 5 percent APM Incentive Payment. Therefore, we encourage organizations with both greater and fewer than 50 clinicians to consider the ability of Medical Home Models such as CPC+ to help develop care infrastructure and transform practices to be more patient-centered and value-oriented.
We are finalizing as proposed the limitation on applicability of the Medical Home Model financial risk and nominal amount standard to APM Entities with fewer than 50 eligible clinicians in their parent organizations. This limitation would not apply to the first QP Performance Period that begins in 2017. Therefore, any APM Entity participating in a Medical Home Model that meets the unique Medical Home Model Advanced APM standards will be considered to be participating in an Advanced APM and have the opportunity to become a QP for purposes of payment year 2019. Starting in the QP Performance Period that begins in 2018, the Medical Home Model Advanced APM financial risk standard would not apply for APM Entities that are owned and operated by organizations with greater than 50 eligible clinicians. As such, participation in a Medical Home Model Advanced APM by such an Advanced APM Entity would not offer the opportunity to attain QP status through that Medical Home Model unless the Medical Home Model meets the generally applicable Advanced APM financial risk criterion. Beginning for the QP Performance Period starting in 2018, we will make this size limit determination for APM Entities in relevant Medical Home Models prior to a QP Performance Period using the most recently available information from the year prior to the QP Performance Period. Therefore, the first determinations of organization size will take place in 2017 using information gathered in 2017. We intend to collect the necessary information through the Medical Home Model operations and will issue guidance on how and when we will do so.
We proposed that full capitation risk arrangements would meet the Advanced APM financial risk criterion. We proposed that, for purposes of this rulemaking, a capitation risk arrangement means a payment arrangement in which a per capita or otherwise predetermined payment is made to an APM Entity for all items and services furnished to a population of beneficiaries, and no settlement is performed for the purpose of reconciling or sharing losses incurred or savings earned by the APM Entity. We also reiterated that Medicare Advantage and other private plans paid to act as insurers on the Medicare program's behalf are not Advanced APMs.
We believe that capitation risk arrangements, as defined here, involve full risk for the population of beneficiaries covered by the arrangement, recognizing that it might require no services whatsoever or could require exponentially more services than were expected in calculating the capitation rate. The APM Entity bears the full downside and upside risk in this regard. Thus, we believe capitation arrangements inherently require an APM Entity to bear financial risk for monetary losses in excess of a nominal amount. We proposed that, where payment is made to participating entities in an APM using a capitation risk arrangement, the APM and participating entities would meet the criterion under section 1833(z)(3)(D)(ii)(I) of the Act.
In implementing this proposed policy, it is important to distinguish capitation as a risk arrangement from capitation as only a cash flow mechanism. A capitation risk arrangement adheres to the idea of a global budget for all items and services to a population of beneficiaries during a fixed period of time. Cash flow mechanisms that make payments in predetermined amounts that are later reconciled or adjusted based on actual services are not necessarily a full risk arrangement. For example, an APM Entity has a capitation arrangement under an APM that pays $1,000 per beneficiary per month for a population of 100 beneficiaries, totaling $1.2 million per year. If expenditures for services actually furnished to these beneficiaries would have totaled $1.3 million if paid on a FFS basis, a payment mechanism without risk might make a reconciliation payment of $100,000 to the entity. In that case, the APM Entity is not bearing any financial risk for monetary losses under the APM. If there is partial reconciliation, the arrangement would not meet the proposed capitation risk arrangement definition but still may meet the financial risk and nominal amount standards through the assessments described in this section above. In contrast, if this arrangement is a capitation risk arrangement, there would be zero reconciliation for those losses. Under our proposal, we would categorically accept that a capitation risk arrangement under an APM would meet the Advanced APM financial risk criterion.
We solicited comment on our proposal for the categorical acceptance of capitation risk arrangements as satisfying the Advanced APM financial risk criterion and on our proposed definition of a capitation risk arrangement. We also solicited comment on other types of arrangements that may be suitable for such treatment for purposes of this financial risk criterion. Finally, we solicited comment on potential limits or qualifications to the capitation standard to prevent potential abuse or incentives that are not consistent with the provision of high value care.
The following is a summary of the comments we received regarding our proposal to consider full capitation risk arrangements to meet the Advanced APM financial risk criterion.
For payment arrangements that do not meet this definition of full capitation, we would still assess the arrangement under the applicable financial risk criterion. Therefore, partial capitation arrangements could meet the criterion so long as the magnitude of the payments at risk involved in the arrangement meets the nominal amount standard and the arrangement is actually a risk arrangement rather than a cash flow mechanism.
Finally, we appreciate the commenter's concern that a high prevalence of capitation arrangements without sufficient quality performance requirements could misplace incentives for delivering high value care. We will monitor the impact of Advanced APMs with capitation arrangements in the future, especially as the All-Payer Combination Option becomes available beginning in payment year 2021. We also believe that this concern is mitigated in part by the Advanced APM MIPS-comparable quality measure requirement, described earlier in this section, because Advanced APMs must also base payment at least in part on meaningful quality measures instead of entirely on cost performance.
We are finalizing the policy that full capitation arrangements would meet the Advanced APM financial risk criterion. All other payment arrangements would be assessed against the applicable nominal amount standards set forth in this final rule.
Section 1833(z)(3)(D)(ii)(II) of the Act states that an Advanced APM must either meet the financial risk criterion or be a Medical Home Model expanded under section 1115A(c) of the Act. We refer to the latter criterion as the expanded Medical Home Model criterion. We proposed that a Medical Home Model that has been expanded under section 1115A(c) of the Act would meet the expanded Medical Home Model criterion and thus would not need to meet the Advanced APM financial risk criterion as described above. Under this proposal, an APM would have to both be determined to be a Medical Home Model as defined in this rulemaking and in fact be expanded using the authority under section 1115A(c) of the Act. Such expansion is contingent upon whether, for an APM tested under section 1115A(b) of the Act:
• The Secretary determines that such expansion is expected to reduce spending under the applicable title without reducing the quality of care; or improve the quality of patient care without increasing spending;
• CMS' Chief Actuary certifies that such expansion would reduce (or would not result in any increase in) net program spending under the applicable titles; and
• The Secretary determines that such expansion would not deny or limit the coverage or provision of benefits under the applicable title for applicable individuals. In determining which models or demonstration projects to expand under the preceding sentence, the Secretary shall focus on models and demonstration projects that improve the quality of patient care and reduce spending.
We note that the expanded Medical Home Model criterion cannot be met unless a Medical Home Model has been expanded under section 1115A(c). Merely satisfying expansion criteria would not be sufficient to meet this Advanced APM criterion. This expanded Medical Home Model criterion is directly related to a similar criterion addressed in the proposed rule for Medicaid Medical Home Models, which addresses how such APMs can meet the Other Payer Advanced APM financial risk criterion by having criteria comparable to an expanded Medical Home Model. We requested comments on the proposed requirements for this and all proposed Advanced APM criteria.
The following is a summary of the comments we received regarding our proposal that Medical Home Models that are expanded under section 1115A(c) of the Act would meet the Advanced APM financial risk criterion.
With respect to the narrowness of this policy, we believe that we do not have the statutory authority to broaden the standard to include Medical Home Models that have not actually been expanded. Section 1833(z)(3)(D)(ii)(II) of the Act is quite clear in its reference to expansion under section 1115A(c) of the Act.
We are finalizing the expanded Medical Home Model policy as proposed. An APM that is determined to be a Medical Home Model and has in fact been expanded using the authority under section 1115A(c) of the Act meets the Advanced APM financial risk criterion.
In the proposed rule, we used the proposed Advanced APM criteria to identify the current APMs that we anticipate would be Advanced APMs for the first QP Performance Period. The list of proposed Advanced APMs was based on the application of criteria in the proposed rule and did not preclude any changes to the list based on: (1) any changes made to the proposed criteria or their application in this final rule; (2) any modifications to the design of
The following is a summary of the comments we received on the preliminary assessment of which current APMs meet the Advanced APM criteria.
In the proposed rule, we noted that the CJR model did not meet the proposed Advanced APM criteria. We solicited comment on how we might change the design of CJR through future rulemaking to make it an Advanced APM, and we solicited comment on how to include eligible clinicians in CJR for purposes of the QP determination as described in section II.F.5. of this final rule with comment period.
The following is a summary of the comments we received regarding our request for comments on how to redesign the CJR model to make it an Advanced APM.
We agree with commenters that one way for CMS to encourage more participation in Advanced APMs is to assess and modify existing APMs to meet the criteria for Advanced APMs. We considered this in developing proposed amendments to CJR (81 FR 50793), and we are considering implementing a new voluntary bundled payment APM for CY 2018 that could meet the Advanced APM criteria.
The QP determination process is specified under section 1833(z)(2) of the Act, in which QPs are defined as those eligible clinicians who meet the specified threshold(s). We proposed a process for determining which eligible clinicians would be QPs or Partial QPs for a given payment year through their participation in Advanced APMs during a corresponding QP Performance Period. Per sections 1833(z)(2) and 1848(q)(1)(C)(ii)(I) and (II) of the Act, an eligible clinician would become a QP or Partial QP for a payment year if they are determined at the end of the performance period to be eligible clinicians in an Advanced APM Entity that collectively meets the threshold values for participation in an Advanced APM during the corresponding QP Performance Period, and starting in 2021, the threshold values for participation in an Other Payer Advanced APM as proposed here. We proposed to determine each year whether an eligible clinician achieved the threshold level of participation to become a QP or Partial QP during the corresponding QP Performance Period. We would make this assessment independent of QP or Partial QP determinations made in previous years and accounting for Advanced APMs that begin or end on timeframes that do not align precisely with the QP Performance Period. The following would apply to an eligible clinician whom CMS determines to be a QP for a particular year:
• For payment years 2019-2024, the QP will receive a lump sum payment equal to 5 percent of the estimated aggregate payment amounts for Medicare Part B covered professional services for the prior year, as described in section II.F.8. of this final rule with comment period;
• The QP will be excluded from MIPS payment adjustments, as described in section II.E.3. of this final rule with comment period; and
• For payment years 2026 and later, payment rates under the Medicare PFS for services furnished by the eligible clinician will be updated by the 0.75 percent qualifying APM conversion factor as specified in sections 1848(d)(1)(A) and (d)(20) of the Act.
Through the APM Entity group determination described in section II.F.5.b. of this final rule with comment period, we would identify eligible clinicians who do not meet the QP Threshold but reach the Partial QP Threshold for a year to be Partial QPs. Partial QPs would not be eligible for the 5 percent APM Incentive Payment for years from 2019 through 2024 or, beginning for 2026, the qualifying APM conversion factor. However, Partial QPs would have an opportunity to decide whether they wish to be subject to a MIPS payment adjustment, which could be positive or negative.
The statute requires that we use two options to determine whether an eligible clinician is a QP or a Partial QP for a payment year—one is the Medicare Option and, beginning in 2021, the other is the All-Payer Combination Option. While these are the terms based on statutory language that we have chosen to use for the purposes of describing the process by which we can calculate an eligible clinician's Threshold Score, we note that the use of the word “option” does not imply that an eligible clinician will have the ability to choose between the two. We further outlined in the proposed rule our proposed process by which we will assess eligible clinicians under both options (beginning in 2021) to the extent that sufficient data is submitted to us.
The Medicare Option focuses on participation in Advanced APMs, and we would make determinations under this option based on Medicare Part B covered professional services attributable to services furnished through an Advanced APM Entity. The Medicare Option is the only option available for QP determinations during the first 2 years of this program (payment years 2019-2020). The All-Payer Combination Option, described in section II.F.7. of this final rule with comment period, is applicable beginning in the third payment year (2021) and would allow us to make determinations based on participation in both Advanced APMs and Other Payer Advanced APMs. The All-Payer Combination Option would not replace or supersede the Medicare Option; instead, it would allow eligible clinicians to become QPs by meeting a relatively lower threshold based on Medicare Part B covered professional services through Advanced APMs and an overall threshold based on services through both Advanced APMs and Other Payer Advanced APMs. With our QP Threshold Score methodologies finalized in this rule, we generally interpret payments “through” an Advanced APM Entity to mean payments made by us for services furnished to attributed beneficiaries, who are the beneficiaries for whose costs and quality of care an Advanced APM Entity is responsible under the Advanced APM. Under section 1848(q)(1)(C)(iii) of the Act, the calculations used for Partial QP determinations are the same, but the threshold percentages to be a Partial QP for each year are lower than those required to be a QP.
The QP and Partial QP Thresholds under the Medicare Option are shown in Tables 32 and 34 of this final rule with comment period. The QP and Partial QP Threshold values under the All-Payer Combination Option are shown in Tables 33 and 35 of this final rule with comment period. We will determine an eligible clinician's QP status for a payment year by calculating an eligible clinician's Threshold Score, and comparing the eligible clinician's Threshold Score (either based on payment amounts or patient counts) to the relevant QP Threshold or Partial QP Threshold. In addition, we discussed our proposal to make QP determinations at a group level based on an entire Advanced APM Entity in section II.F.5.b of the proposed rule (81 FR 28319-28321).
According to section 1833(z)(2)(D) of the Act, the Secretary may base the determination of whether an eligible
By performing preliminary analyses using our proposed QP determination methodologies with historical APM data, we found that the proposed QP and Partial QP Patient Count Thresholds are similar in magnitude and trajectory to those specified in the statute for the payment-based calculations. Due to varying attribution and organizational characteristics, we anticipate that using our proposed thresholds, the method—payment amount or patient count—that results in the most favorable QP status will likely vary across different Advanced APMs and Advanced APM Entities. We believe that each eligible clinician should have every opportunity to reach the QP threshold for each year, and do not intend to limit this opportunity by preemptively selecting one method over another.
We solicited comment on the proposed QP Patient Count Threshold and Partial QP Patient Count Threshold percentage values for both the Medicare Option and the All-Payer Combination Option.
The following is a summary of the comments we received regarding our proposed QP Patient Count Thresholds and Partial QP Patient Count Thresholds.
After considering the public comments, we are finalizing the QP Patient Count Thresholds and Partial QP Patient Count Thresholds as proposed, and we are finalizing the QP Payment Amount Threshold and Partial QP Payment Amount Thresholds as specified in statute.
We proposed that, beginning with payment year 2021, we would conduct the QP determination sequentially so that the Medicare Option is applied before the All-Payer Combination Option. We proposed to apply the All-Payer Combination Option only to an Advanced APM Entity group of eligible clinicians or eligible clinicians who do not meet either the QP Payment Amount or Patient Count Threshold under the Medicare Option but who do meet the lower Medicare threshold for the All-Payer Combination Option. This process is illustrated in Figures C and D of this final rule with comment period, which show that the first assessment is whether the Medicare QP Threshold has been met under either the Medicare Option or the All-Payer Combination Option.
Because in addition to being a standalone path to QP status, the Medicare Option (either based on payment amounts or patient counts) is also a component of the All-Payer Combination Option, and because all eligible clinicians must reach at least a minimum Threshold Score through Advanced APMs to be QPs, we believe that this sequential approach streamlines the analytic and operational requirements to make QP determinations under the All-Payer Combination Option. Figure C illustrates the proposed process for making QP determinations under the Medicare Option for 2019 and 2020. Figure D illustrates the process proposed for making QP determinations under both the Medicare and All-Payer Combination Options for payment years 2021-2024. Figure E provides an example of the proposed process for making QP determinations in payment years 2023-2024. Figures C, D, and E only illustrate the payment amount method, but a similar process would apply for the patient count method.
The following is a summary of the comments we received regarding our proposal to assess Advanced APM Entities sequentially under the Medicare Option and, only if necessary, under the All-Payer Combination Option.
We are finalizing the policy as proposed. Beginning with payment year 2021, we will conduct the QP determination sequentially so that the Medicare Option is applied before the All-Payer Combination Option. We will apply the All-Payer Combination Option only to an Advanced APM Entity group of eligible clinicians who do not meet either the QP Payment Amount or Patient Count Thresholds under the Medicare Option but who do meet the lower Medicare threshold for the All-Payer Combination Option.
The following is a summary of comments regarding the QP determination process generally.
We disagree with the commenter that current APM participants should have an easier path to QP status than APM participants who have never previously participated in APMs. While we greatly appreciate the early adopters of Advanced APMs, we find no policy justification for making it relatively more difficult for those who have never participated in an Advanced APM to achieve QP status because, as stated above, a core purpose of this program is to increase Advanced APM participation.
The statute consistently refers to an eligible clinician throughout section 1833(z) of the Act and clearly identifies that the QP determinations are to be made for an eligible clinician, whom we identify by a unique NPI. Thus, an eligible clinician is a person who may have multiple TIN/NPI combinations but only one NPI. In section 1833(z)(3)(B) of the Act, the definition of an eligible clinician includes a group of such clinicians.
We proposed, in general, to make the QP determination at a group level. As a result, the QP determination for the group would apply to all the individual eligible clinicians who are identified as part of an Advanced APM Entity. If that eligible clinician group's collective Threshold Score meets the relevant QP threshold, all eligible clinicians in that group would receive the same QP determination, applied to their NPI, for the relevant year. The QP determination calculations described in the proposed rule would be aggregated using data for all eligible clinicians participating in the Advanced APM Entity during the QP Performance Period.
We believe that this policy promotes administrative simplicity and collaboration among group members instead of promoting barriers, and while many beneficiaries are attributed to an APM Entity based on the services rendered by one eligible clinician, many of the eligible clinicians participating in the APM Entity may play a role in the actual diagnosis, treatment, and management of many beneficiaries in the APM Entity population. Each of these individual eligible clinicians could potentially view themselves as being instrumental in providing quality care to the beneficiary that is in line with the objectives of the APM, regardless of whether their individual services are counted towards APM-specific attribution methods.
An Advanced APM Entity faces the risks and rewards of participation in an Advanced APM as a single unit, and is responsible for performance metrics that are aggregated to the level of that entity. This policy is based on the premise that positive change occurs when entire organizations commit to participating in an Advanced APM and focusing on its cost and quality goals as a whole. It also mitigates situations in which individual eligible clinicians who practice together in an Advanced APM Entity receive different QP determinations and thus are treated differently for purposes of APM Incentive Payments, MIPS payment adjustments, and eventually, differential fee schedule updates under the PFS. We believe that such discrepancies could potentially lead to confusion and lack of cohesion among eligible clinicians and Advanced APM Entities and place additional burdens on eligible clinicians and organizations to track these differences. Additionally, we wish to avoid any additional burden, confusion, and operational difficulties for both eligible clinicians and CMS that would result from allowing eligible clinicians or Advanced APM Entities to elect whether to be assessed at the Advanced APM Entity level. We believe that a simple, overarching rule is preferable to adding extra variables to the already complex processes under this program.
The following is a summary of the comments we received regarding our proposal to make the QP determination at the Advanced APM Entity group level.
Except as explained further below, we are finalizing the proposed policy to make QP determinations collectively using the group of eligible clinicians in an Advanced APM Entity. We are finalizing two exceptions to this policy. First, if the eligible clinicians are identified on an Affiliated Practitioner List rather than a Participation List, as described in this section below, we will perform the QP determination individually for each eligible clinician on the Affiliated Practitioner List. We believe that eligible clinicians on Affiliated Practitioner Lists are unlike eligible clinicians on Participation Lists because, although they may have similar relationships with the Advanced APM Entity, they may not have any relationship with one another and do not represent a single organization unified in APM-related goals. Therefore, we believe considering these eligible clinicians individually is the most appropriate approach. We finalize the other exception regarding eligible clinicians participating in multiple Advanced APMs in section II.F.5.a.3. of this final rule with comment period.
We understand that, as with any group assessment, there will be some situations in which individual Threshold Scores would differ from group Threshold Scores if assessed separately. This could lead to some eligible clinicians becoming QPs when they would not have met the QP Threshold individually (a “free-rider” scenario) or, conversely, some eligible clinicians not becoming QPs within an Advanced APM Entity when they might have qualified individually (a dilution scenario). We believe that through the methodology we are finalizing for QP determinations in this final rule, the magnitude of such discrepancies will be relatively small compared to the value of maintaining Advanced APM Entity cohesion.
We proposed that the group of eligible clinicians used for a collective QP determination would consist of all the eligible clinicians participating in an Advanced APM Entity during a QP Performance Period. This would be defined by an Advanced APM Entity's Participation List provided to CMS. We proposed that the Participation List for each Advanced APM Entity would be compiled from CMS-maintained lists that identify each eligible clinician by a unique TIN/NPI combination attached to the identifier of the Advanced APM Entity.
We proposed two exceptions to this rule. One exception is for Advanced APMs that do not identify eligible clinicians on a Participation List. In certain Advanced APMs, a Participation List may not include eligible clinicians. For example, in an APM where all Advanced APM Entities are hospitals, the Advanced APM Entity may not have eligible clinicians identified by a unique TIN/NPI combination attached to the identifier of the Advanced APM Entity on a Participation List. On the other hand, in certain Advanced APMs, an Advanced APM Entity may have a list (Affiliated Practitioner List) of other entities, including eligible clinicians, who are affiliated with and support the Advanced APM Entity in its participation in the Advanced APM but are not on the Participation List. For example, an Affiliated Practitioner List comprised of gainsharers under an APM might include eligible clinicians whereas a Participation List may only include hospitals.
Where there is a Participation List that can be used to identify eligible clinicians, we proposed that it be the only list that is considered for the QP determination. We proposed that for Advanced APMs where the Participation List does not identify eligible clinicians, but there is an Affiliated Practitioners List of eligible clinicians who have a contractual relationship with the Advanced APM Entity based at least in part on supporting the Advanced APM Entity's quality or cost goals under the Advanced APM, we would use the eligible clinicians on the Affiliated Practitioner List for purposes of the QP determination. Where there is both a Participation List and an Affiliated Practitioner List that can be used to identify eligible clinicians under an Advanced APM, we proposed to only use the Participation List for purposes of the QP determination.
This proposed policy was developed to capture the group or groups of eligible clinicians who are the most closely associated with the performance of the Advanced APM Entity under an Advanced APM and to recognize their role in supporting the Advanced APM Entity. We believe this policy provides for flexibility in the design of Advanced APMs while providing the APM Incentive Payment to those eligible clinicians who are the most engaged in the Advanced APM.
We solicited comment on our proposals to define the eligible clinician group for QP determination based on the Participation List and the exception to use the Affiliated Practitioners List for Advanced APMs in which there are not eligible clinicians on the Participation List. We also solicited comment on whether to limit the proposed policy to the Medicare Option, as it may be less likely that Affiliated Practitioners support the Advanced APM Entity in Other Payer Advanced APMs and may be more difficult for us to distinguish based on information submitted to CMS by Advanced APM Entities. Because there may be Advanced APMs in the future that have
The following is a summary of the comments we received regarding our proposals pertaining to defining the eligible clinician groups for QP determination.
A few commenters made specific comments on how the proposed policy relates to episode payment models. Some commenters suggested that if BPCI or CJR become Advanced APMs, CMS should accept a hospital's Affiliated Practitioner List for the QP determination. A commenter suggested that CMS create a process for APM Entities in episode payment models to report their Affiliated Practitioners out of concern that ACOs will exclude specialists so that their primary care physicians will as a group be QPs.
In response to the comment requesting that we identify Affiliated Practitioners for the QP determination in BPCI, we are finalizing an exception that would allow for the appropriate identification of eligible clinicians in APMs that, like BPCI, have multiple types of participating APM Entities. Under this exception, we will use either the Participation List or the Affiliated Practitioner List depending on the type of APM Entity. This exception applies to Advanced APMs, such as some episode payment models, in which different types of APM Entities participate and some Advanced APM Entities may identify eligible clinicians on a Participation List, and others may have only an Affiliated Practitioner List. For these models, we will identify the eligible clinicians for QP determinations based on the composition of the Advanced APM Entity instead of at the Advanced APM level. Specifically, for these episode payment model Advanced APMs, we will determine which eligible clinicians will be included in the QP determination as follows: (1) For Advanced APM Entities that include and identify eligible clinicians on a Participation List, that Participation List will be used to define the Advanced APM Entity group, regardless of whether or not there is also an Affiliated Practitioner List or other list of eligible clinicians, and we will make QP determinations at the APM Entity group level; (2) for Advanced APM Entities that do not include and identify eligible clinicians on a Participation List and there is an Affiliated Practitioner List that identifies eligible clinicians, that Affiliated Practitioner List will be used to identify the eligible clinicians for purposes of QP determination, and those eligible clinicians will be assessed individually. The structure of BPCI serves as a useful example to show how we would apply this policy. In a model like BPCI, when the APM Entity is a physician group practice that identifies eligible clinicians on a Participation List, we would use that list for purposes of the QP determination, even if there is also an Affiliated Practitioner List. When the APM Entity is a hospital that does not identify eligible clinicians on a Participation List, but it identifies eligible clinicians on an Affiliated Practitioner List, we would use that list for purposes of identifying eligible clinicians for the QP determination, and those eligible clinicians would be evaluated individually. While this policy is responsive to comments about APMs like BPCI, this policy does not change the design of the models within BPCI. We are also considering implementing a new voluntary APM that is an episode payment model for CY 2018 that could meet the criteria for this exception (81 FR 50793).
We believe this exception to making QP determinations at a group level appropriately identifies the eligible clinicians with the closest supporting role to the Advanced APM Entity in episode payment models. We would assess affiliated practitioners individually because affiliated practitioners do not necessarily have the same organizational relationship with one another as eligible clinicians on a Participation List have with one another. Unlike APM Entities that are defined as a group of eligible clinicians, affiliated practitioners may have no common connection to each other aside from their mutual relationship with a facility. Therefore, we believe that the rationale for group assessments does not apply to these individual eligible clinicians.
The policy we are finalizing addresses which eligible clinicians, those on a Participation List or those on an Affiliated Practitioner List, will be considered for the QP determination. We believe that we should only capture those eligible clinicians affirmatively identified as the most central participants supporting an Advanced APM Entity for purposes of the QP determination. Many APMs have multiple “tiers” of eligible clinicians who may play different roles for an APM Entity, and the policy we are finalizing reflects those tiers so that only the eligible clinicians most responsible for the requirements of the Advanced APM relative to other tiers of eligible clinicians will be considered the central participants of an Advanced APM Entity. Where Advanced APM Entities have eligible clinicians identified on a Participation List, those eligible clinicians are the most central participants. Where Advanced APM Entities do not have eligible clinicians identified on a Participation List, but they do have eligible clinicians on an Affiliated Practitioner List, those eligible clinicians are the most central participants.
We are finalizing the proposed policy with certain modifications, as follows:
• For Advanced APMs for which there is a Participation List that identifies eligible clinicians, that Participation List will be used to define the Advanced APM Entity group, regardless of whether there is also an Affiliated Practitioner List or other list of eligible clinicians associated with the Advanced APM. QP determinations will be made at the Advanced APM Entity group level.
• For Advanced APMs for which there is not a Participation List that identifies eligible clinicians and there is an Affiliated Practitioner List that identifies eligible clinicians, that Affiliated Practitioner List will be used to identify the eligible clinicians for purposes of QP determinations. Eligible clinicians on an Affiliated Practitioner List will be assessed individually, unlike eligible clinicians on a Participation List who are assessed as a group.
• For Advanced APMs, such as episode payment models, in which there are some Advanced APM Entities that include eligible clinicians on a Participation List and other Advanced APM Entities that identify eligible clinicians only on an Affiliated Practitioner List, we will identify eligible clinicians for QP determinations based on the composition of the Advanced APM Entity: (1) For Advanced APM Entities that include and identify eligible clinicians on a Participation List, that Participation List will be used to define the Advanced APM Entity group, regardless of whether or not there is also an Affiliated Practitioner List or other list of eligible clinicians, and those eligible clinicians will be assessed as a group; (2) for Advanced APM Entities that do not include and identify eligible clinicians on a Participation List and there is an Affiliated Practitioner List that identifies eligible clinicians, that Affiliated Practitioner List will be used to identify the eligible clinicians for purposes of QP determinations, and those eligible clinicians will be assessed individually.
As discussed in our response to comments above, we believe the relationship between eligible clinicians and APM Entities in APMs such as episode payment models can vary and that eligible clinicians on an Affiliated Practitioner List can be engaged in the goals of the Advanced APM in a similar manner as eligible clinicians on a Participation List depending on the characteristics of the Advanced APM Entity.
We are finalizing these policies on the identification of eligible clinicians for purposes of QP determinations only for the Medicare Option. We did not receive public comment on whether to extend this policy to the All-Payer Combination Option and believe it is prudent to first apply this policy in the Medicare Option before considering whether to apply it in the All-Payer Combination Option through future rulemaking.
We proposed an exception to making QP determinations at the group level. Some eligible clinicians may participate in multiple Advanced APMs. For instance, an eligible clinician could participate in an ACO under the Shared Saving Program and an episode payment model with another entity, both of which have been determined to be Advanced APM Entities. In such a case, we proposed the following (81 FR 28320):
• Consistent with the general policy proposed above, if one or more of the Advanced APM Entities in which the eligible clinician participates meets the QP threshold, the eligible clinician becomes a QP.
• If none of the Advanced APM Entities in which the eligible clinician participates meet the QP threshold, CMS proposes to assess the eligible clinician individually, using combined information for services associated with that individual's NPI and furnished through all such eligible clinician's Advanced APM Entities during the QP Performance Period. We would adjust to assure that services are not double-counted (for example, a surgeon participating in an episode payment model, in which some of the procedures are performed on patients affiliated with an ACO that the surgeon is also a part of, would only have payments or patients from those procedures count once towards the QP determination).
We believe that this policy maintains the general simplicity of the Advanced APM Entity-level QP determination while acknowledging individual eligible clinicians who are participating in multiple advanced initiatives that support CMS goals. This also complements the policy described under the All-Payer Combination Option for QP determinations in which an eligible clinician may submit information on participation in Other Payer Advanced APMs to be assessed as an individual under that option in the event that the APM Entity or Entities in which the eligible clinician participates do not submit sufficient information.
We solicited comment on the proposal for exceptions to making QP determinations at the Advanced APM Entity level. In particular, we solicited comment on the merits of making all determinations at the individual eligible clinician level versus through some alternative grouping methodology. We also solicited comment on our proposal to assess an eligible clinician who participates in multiple Advanced APM Entities, and any other potential exceptions to the proposed general policy to make QP determinations at the Advanced APM level.
The following is a summary of the comments we received regarding our proposal to assess an eligible clinician individually for purposes of a QP determination in the event that the eligible clinician participates in multiple Advanced APM Entities, none of which meet the QP thresholds as a group.
We are finalizing the policy as proposed. If an eligible clinician participates in multiple Advanced APM Entities during a QP Performance Period, and is not determined to be a QP based on participation in any of those Advanced APM Entities, then we will assess the eligible clinician individually using combined information for services associated with that individual's NPI and furnished through all the eligible clinician's Advanced APM Entities during the QP Performance Period. This includes all Advanced APM Entities for which the eligible clinician is represented on either a Participation List or Affiliated Practitioner List that CMS uses for QP determinations in accordance with the identification policies described in this section of the final rule with comment period. We will make adjustments to ensure that patients and payments for services that may be counted in the QP calculations for multiple Advanced APM Entities (for example, payments for services furnished to a beneficiary attributed to an ACO that are also part of an episode in an episode payment model) are not double-counted for the individual.
We believe that this policy maintains the general principles behind Advanced APM Entity-level QP determinations while acknowledging the broader commitment of individual eligible clinicians who are participating in multiple Advanced APMs. We believe considering these eligible clinicians individually is the most reasonable approach to capturing the multiple potential permutations of participation in Advanced APMs and providing eligible clinicians an equitable opportunity to become a QP.
We proposed that we would identify the eligible clinician group for each Advanced APM Entity at a specified point in time for each QP Performance Period. We proposed that this point-in-time assessment will occur on December 31 of each QP Performance Period.
We solicited comments on our proposal to define the Advanced APM Entity group based on the Participation List for each Advanced APM Entity at a specified point in time during the QP Performance Period. We also solicited comment on the proposed date of the Participation List assessment, and whether this date should be earlier in the QP Performance Period or should instead be a range of time (81 FR 28320).
The following is a summary of the comments we received regarding our proposal to define the Advanced APM Entity group for purposes of the QP determination by take a point-in-time snapshot of eligible clinicians in an Advanced APM Entity according to Participation Lists on December 31 of the QP Performance Period.
To address the comments we received, especially the concerns regarding eligible clinicians not knowing whether they are part of an Advanced APM Entity for purposes of QP determinations until the end of the calendar year, we are finalizing a modified process for identifying the APM Entity group (individual eligible clinicians in the case of an Affiliated Practitioner List) to use a series of three “snapshots” of an APM Entity's Participation List (or Affiliated Practitioner List) during the QP Performance Period. Each snapshot may add eligible clinicians to the APM Entity group or capture new affiliated practitioners who were not previously identified as part of the group or as individuals in the Advanced APM, but once determined to be a participant in an APM Entity for the QP Performance Period at any of the three snapshots, an eligible clinician will be considered by CMS for QP determinations as part of an APM Entity group, or as an individual, as appropriate, regardless of whether they are included on a Participation List or Affiliated Practitioner List in later snapshots. The first snapshot will be on March 31 of the QP Performance Period, the second snapshot will be on June 30 of the QP Performance Period, and the third snapshot will be on the August 31, which will be the last day of the QP Performance Period.
Each of these snapshots will establish and then add to the APM Entity group used for purposes of the QP determinations made for the QP Performance Period described in this section. In the event that the APM Entity participates in a MIPS APM and is not excluded from MIPS, the final APM Entity group after the third snapshot will be also be the APM Entity group used for purposes of MIPS group reporting and scoring under the APM scoring standard described in section II.e.3.h. of this final rule with comment period.
We believe that this final policy accommodates the variety of policies in different models regarding the adding or dropping of APM participants so that we capture the eligible clinicians who have meaningfully participated in an Advanced APM Entity during a QP Performance Period. Most importantly, we believe that, in combination with the final policy on the QP Performance Period, this policy allows for substantially greater certainty at an earlier point in time of an eligible clinician's status, first as a participant or
We acknowledge that use of point-in-time snapshots may result in some eligible clinicians being captured on Participation Lists or Affiliated Practitioner Lists when they have only been on such a list for a short period of time. Although we believe that most APMs have list management rules to inhibit potential manipulation and that large numbers of additions to a Participation List may reduce an Advanced APM Entity's Threshold Score, we will monitor whether APM Entities systematically construct their lists in a manner that inappropriately affects the assessment of participation in Advanced APMs. In response, we may modify our policy through future rulemaking to address any such issues.
According to section 1833(z)(2) of the Act, we are required to determine QP and Partial QP status based on payment amounts or patient counts during the most recent period for which data are available, which may be less than a year. We proposed that the QP Performance Period is the full calendar year that aligns with the MIPS performance period (for instance, 2017 would be the QP Performance Period for the 2019 payment year). We believe that having a QP Performance Period that concludes 1 year and one day before the payment year would enable us to provide all eligible clinicians participating in Advanced APMs the best opportunity to monitor their performance through the Advanced APM and make the most informed decisions regarding their decision whether to not to be subject to MIPS in the event that they become a Partial QP. We solicited comment on this proposal and any alternative QP Performance Period timeframes that would both enable meaningful QP assessment and ensure operational alignment with MIPS.
The following is a summary of the comments we received regarding our proposal that the QP Performance Period would be the full calendar year 2 years prior to the payment year.
That said, we agree in principle that earlier notification of QP status is optimal and would prevent wasted time and resources. Our analyses indicate that one calendar quarter's data is sufficiently reliable and consistent with full year results to make early final QP determinations using those data. Thus, we are modifying our proposed policy in this final rule, as explained more fully below, to incorporate QP determinations during the calendar year based on data from less than the full QP Performance Period. Any such QP determination made during the QP Performance Period will be considered final. QP determinations may be rescinded in the event that an Advanced APM Entity is terminated from an Advanced APM, voluntarily or involuntarily, prior to August 31 of the QP Performance Period, or in the event of eligible clinician or Advanced APM Entity program integrity violations, as described in section II.F.9. of this final rule with comment period. We also intend to provide preliminary information to eligible clinicians participating in an Advanced APM early in the QP Performance Period in order to help participants assess their likelihood of becoming a QP for a year. For the first performance year, we will calculate hypothetical Threshold Scores based on historical claims data and current attribution data that represent an approximation of QP status as if the eligible clinicians had participated in an Advanced APM in 2016.
We are modifying our proposals for the QP Performance Period and the timing of QP determinations. Instead of the proposed policy, we are finalizing a QP Performance Period that runs from January 1 through August 31 of the calendar year that is 2 years prior to the payment year. During that QP Performance Period, we will make QP determinations at three separate times, each of which would be a final determination for the eligible clinicians who are determined to be QPs. The QP Performance Period and the three separate QP determinations apply similarly for both the group of eligible clinicians on a Participation List and the individual eligible clinicians on an Affiliated Practitioner List.
The first QP determination of the QP Performance Period will be made for all eligible clinicians who are identified as Advanced APM participants eligible to be QPs, either through a Participation List or Affiliated Practitioner List as described above, as of March 31 using data for that Advanced APM Entity group from January 1 through March 31 of that year. If the APM Entity group meets the QP threshold under this first assessment, then all eligible clinicians in the Advanced APM Entity group will be QPs for purposes of the respective payment year unless the Advanced APM Entity's participation in the Advanced APM is voluntarily or involuntarily terminated prior to the end of the QP Performance Period, or in the event of eligible clinician or Advanced APM Entity program integrity violations, as described in section II.F.9. of this final rule with comment period. These same procedures apply to the first QP determination made for individual eligible clinicians on an Advanced APM
In the event that the Advanced APM Entity group did not meet the QP threshold at the first QP determination, or if the Advanced APM Entity group includes eligible clinicians who were not part of the Advanced APM Entity group at the first QP determination, we will make a second QP determination for all eligible clinicians in the Advanced APM Entity at the first QP determination plus any additional eligible clinicians who are on the Participation List as of June 30 using data for that Advanced APM Entity group from January 1 through June 30 of that QP Performance Period. If the Advanced APM Entity group meets the QP threshold, then all eligible clinicians in the Advanced APM Entity group will be QPs for the payment year unless the Advanced APM Entity's participation in the Advanced APM is voluntarily or involuntarily terminated prior to the end of the QP Performance Period, or in the event of eligible clinician or Advanced APM Entity program integrity violations, as described in section II.F.9. of this final rule with comment period. If the Advanced APM Entity group does not meet the QP threshold at the second determination but did meet the QP threshold at the first determination, CMS would not revise the QP status of the eligible clinicians who were previously determined to be QPs, but any additional eligible clinicians who were in the Advanced APM Entity group at the second determination would not be QPs for the payment year through the group determination. If an Advanced APM Entity group meets the threshold in both the first and second determination, but some eligible clinicians no longer remain on the Participation List for the second determination, those eligible clinicians will still be considered QPs. These same procedures apply to the second QP determination made for individual eligible clinicians on the Advanced APM Entity's Affiliated Practitioner List or individual eligible clinicians in multiple Advanced APMs whose Advanced APM Entity groups did not meet the QP threshold.
In the event that the Advanced APM Entity group did not meet the QP threshold under the first or second QP determination or if the Advanced APM Entity group includes eligible clinicians who were not part of the Advanced APM Entity group at the second QP determination, we will make a third QP determination for all eligible clinicians on the Advanced APM Entity's Participation List from the first and second QP determinations plus any additional eligible clinicians who are on the Participation List as of August 31 using data for that Advanced APM Entity group from January 1 through August 31 of that QP Performance Period. If the Advanced APM Entity group meets the QP thresholds, then all eligible clinicians in the Advanced APM Entity group will be QPs for the payment year unless the Advanced APM Entity's participation in the Advanced APM is voluntarily or involuntarily terminated prior to the end of the QP Performance Period. If the Advanced APM Entity group does not meet the QP threshold at the third determination but did meet the QP threshold at a previous determination, CMS would not revise the QP status of the eligible clinicians who were previously determined to be QPs, but any additional eligible clinicians who were only in the Advanced APM Entity group at the third QP determination would not be QPs for the payment year. If an Advanced APM Entity group meets the QP threshold in both the third determination and a previous determination, but some eligible clinicians no longer remain in the Advanced APM Entity at the third determination, those eligible clinicians will still be considered QPs. These same procedures apply to the third QP determination made for individual eligible clinicians on the Advanced APM Entity's Affiliated Practitioner List or individual eligible clinicians in multiple Advanced APMs whose Advanced APM Entity groups did not meet the QP threshold.
For each of the three QP determinations, we will allow for 3 months' claims run-out before calculating the Threshold Scores so that the three QP determinations will be made approximately 4 months after the end of that determination time period. Therefore, the last of these three QP determinations will take place on or around January 1 of the subsequent calendar year, which is the year immediately prior to the payment year. This way, eligible clinicians will know of their QP status prior to or near the beginning of the MIPS data submission period and know whether they should report to MIPS for the applicable year. Additionally, for purposes of this policy, we do not consider the ending of an Advanced APM's operations to be the voluntary or involuntary termination of an Advanced APM Entity. We consider an Advanced APM's end to be the natural and scheduled close rather than a “dropping out” of participants from the Advanced APM.
Figure G illustrates the three QP determinations during a QP Performance Period and the associated period of claims data used for QP determination (A), the Participation List or Affiliated Practitioner List snapshot date (B), the claims run-out period (C), and the estimated completion date of the QP determination (D).
Section 1848(q)(1)(C)(ii)(II) of the Act excludes from the definition of MIPS eligible clinician an eligible clinician who is a Partial QP for a year. However, under section 1848(q)(1)(C)(vii) of the Act, an eligible clinician who is a Partial QP for a year and reports on applicable measures and activities as required under the MIPS is considered to be a MIPS eligible clinician for the year. To carry out these provisions, we proposed to require that each Advanced APM Entity must make an election each year on behalf of all of its identified participating eligible clinicians on whether to report under MIPS in the event that the eligible clinicians participating in the Advanced APM Entity are determined as a group to be Partial QPs for a year. We proposed that the Advanced APM Entity could change its election for a year at any time during the QP Performance Period, but the election would become permanent at the close of the QP Performance Period. We believe that this is consistent with our proposed general policy to make QP determinations at the Advanced APM Entity level, and with related MIPS policies described in section II.E.3.h. of this final rule with comment period, under which we proposed that each APM Entity would be considered a group for purposes of MIPS reporting. Therefore, we believe that the decision of whether to report and subsequently be subject to MIPS adjustments should also be made at the group level. We solicited comment on whether the Advanced APM Entity or each individual eligible clinician should make the Partial QP MIPS reporting election.
As discussed in section II.E.3.h. of this final rule with comment period, we recognize that the Shared Savings Program eligible clinicians participate as a complete TIN such that all of the eligible clinician participants in the participant billing TIN participate in the Shared Savings Program. Therefore, we also solicited comment on an alternative approach for Shared Savings Program APM Entities in which each individual billing TIN participating in the APM Entity would make the Partial QP election on behalf of its individual eligible clinicians and that election would be applied to all eligible clinicians in that individual billing TIN, as opposed to having the APM Entity (ACO) make the Partial QP election. We stated that we would only undertake this alternative paired with determining a MIPS final score for each TIN within an APM Entity (ACO) at the TIN level, an alternative discussed under the APM scoring standard in the proposed rule.
Our proposal that Partial QPs may choose whether to report to MIPS has two additional interactions with other proposed policies. First, because we proposed unique MIPS scoring policies for MIPS eligible clinicians participating in certain APMs, the election by the APM Entity not to report under MIPS is in effect a decision to tell us not to score the information submitted by the APM Entity under MIPS. Under our proposal, that decision would be made at the APM Entity level. APM Entities and eligible clinicians would continue to report to their respective APMs as required under the terms of their participation agreements with us.
Second, given the proposed timeframe for QP determinations under section II.F.5.a. of the proposed rule (81 FR 28313), our proposed treatment of claims run-out, claims adjustments, supplemental service payments, and alternative payment methods for purposes of QP determination (further detailed in section II.F.8 of the proposed rule (81 FR 28339)), and the and subsequent notification of QP determinations proposed under section II.F.5.d. of the proposed rule (81 FR 28322), eligible clinicians who become Partial QPs would not receive notification of this status until after the proposed timeframe for the MIPS reporting period will have closed. Although the information necessary for MIPS reporting would already be prepared in our systems by the time the Partial QP determination is made, a prospective election by the Advanced APM Entity to not be scored under MIPS and receive a MIPS payment adjustment would signal us to not transfer information from our reporting system to the MIPS scoring system in the event of a Partial QP determination, and that any submitted information is not to be used for purposes of a MIPS assessment or payment adjustment. Thus, by choosing not to report under MIPS, those Advanced APM Entities and eligible clinicians determined to be Partial QPs would be exempted from the MIPS payment adjustment for that year. We solicited comment on the timing and process for Advanced APM Entities to elect whether to be subject to MIPS in the event of a Partial QP determination.
The following is a summary of the comments we received regarding our proposal for Advanced APM Entities to determine whether or not to be subject to MIPS in the event that their eligible clinicians are determined to be Partial QPs.
In consideration of the comments and the modifications we are making to the proposed QP Performance Period policies, we are not finalizing the proposed policy that Advanced APM Entities would make prospective elections regarding whether or not to score their MIPS data in the event that they are determined to be Partial QPs. Instead, we are finalizing a modified policy such that, following a final determination that eligible clinicians in an Advanced APM Entity group are Partial QPs for a year, the Advanced APM Entity will make an election whether to report to MIPS, thus making all eligible clinicians in the Advanced APM Entity group subject to MIPS reporting requirements and payment adjustments for the year; if the Advanced APM Entity elects not to report, all eligible clinicians in the APM Entity group will be excluded from MIPS adjustments. In the cases where the QP determination is made at the individual eligible clinician level, if the eligible clinician is determined to be a Partial QP, the eligible clinician will make the election whether to report to MIPS and then be subject to MIPS reporting requirements and payment adjustments.
A Partial QP who elects not to report to MIPS, whether based on the decision of the APM Entity or the individual eligible clinician, similar to QPs, is excluded from MIPS across all TINs associated with that Partial QP's NPI. Partial QPs do not under any circumstance receive the APM Incentive Payment.
Under this finalized policy, only Partial QPs must make this election after the Partial QP determination is made. The finalized QP Performance Period and QP determination policies apply to Partial QP determinations and enable Partial QP determinations to be made in a timeframe that makes the proposed prospective elections unnecessary. This means that Advanced APM Entities do not make a Partial QP decision on behalf of their constituent eligible clinicians unless and until that group actually is determined to be a Partial QP. Similarly, eligible clinicians for whom we make individual QP determinations do not elect whether to report to MIPS unless and until the eligible clinician is determined to be a Partial QP for the year.
We also clarify how we consider the absence of an explicit election. For situations in which the APM Entity is responsible for making the determination on behalf of all eligible clinicians in the APM Entity group, the group of Partials QPs will not participate in MIPS unless the APM Entity opts the group into MIPS participation so that no actions other than the APM Entity's election for the group to participate in MIPS would result in MIPS participation. We believe that this default minimizes the possibility of unexpected participation in MIPS and also recognizes that most APM Entity groups in this situation would be scored collectively under the APM scoring standard in MIPS, thus necessitating group decision-making.
For situations in which an eligible clinician is determined to be a Partial QP individually, we will use the eligible clinician's actual reporting activity to determine whether to exclude the Partial QP from MIPS in the absence of an explicit election. Therefore, if an eligible clinician determined as an individual to be Partial QP submits information to MIPS (which does not include information automatically populated or calculated by CMS on the Partial QP's behalf), we will consider the Partial QP to have reported and thus be participating in MIPS. Likewise, if an eligible clinician determined as an individual to be a Partial QP does not take any action to submit information to MIPS, then we will consider the Partial QP to have elected to be excluded from MIPS.
We anticipate that there will be relatively few Partial QPs, especially in the first few years of the Quality Payment Program; therefore, we believe that this finalized policy will reduce administrative burden on Advanced APM participants and operate most smoothly with our finalized policies for QP determinations.
We proposed to notify both Advanced APM Entities and their participating eligible clinicians of their QP or Partial QP status as soon as we have made the determination and performed all necessary validation of the results. We proposed that this notification would be made directly to the Advanced APM Entity and eligible clinician, and made in combination with a general public notice on the CMS Web site that such determinations have been completed for the applicable QP Performance Period. We proposed that this notification would also contain other necessary and useful information, such as what actions, if any, an Advanced APM Entity or eligible clinician may or should take with respect to MIPS.
We solicited comment on our proposals to make the QP and Partial QP status notifications. We also solicited comment on other methods and media for the notification of QP and Partial QP status. We also solicited comment on the content of such notifications so that they may be as clear and useful as possible.
The following is a summary of the comments we received regarding our proposal to make notifications regarding the results of QP and Partial QP determinations.
We are finalizing the proposal to notify Advanced APM Entities and eligible clinicians of their QP or Partial QP status as soon as we have made the determination and performed all necessary validation of the results. This notification process will occur for each of the three QP determinations that we will perform during a QP Performance Period. We will provide additional information on the format of such notifications and the data we will include as part of our public communications following this final rule with comment period.
Under the Medicare Option, we proposed to calculate a Threshold Score for an Advanced APM Entity—or eligible clinician in the cases of an exception described in section II.F.5.b. of the proposed rule (81 FR 28319)—based on participation in an Advanced APM by analyzing claims for Medicare Part B covered professional services. Under the alternative calculation using patient counts in lieu of payments (patient count method), we proposed to similarly calculate a Threshold Score for the Advanced APM Entity based on patient attribution as described in the proposed rule. Under either the payment amount or patient count method, only Medicare Part B covered professional services under the PFS will count toward the numerator and denominator of the Threshold Score calculation.
Section 1833(z)(2)(A), (B)(i) and (C)(i) of the Act describes the QP determination using the Medicare payment method as follows: A QP is an eligible clinician whose payments under this part for covered professional services furnished by such professional during the most recent period for which data are available (which may be less than a year) were attributable to such services furnished under this part through an Advanced APM Entity. Section 1833(z)(2)(D) of the Act describes the basis for the patient count method.
In section II.F.3. of the proposed rule (81 FR 28295), we proposed two definitions that would apply specifically for the purposes of QP determination: Attributed beneficiary and attribution-eligible beneficiary. Each term describes a particular relationship between an Advanced APM Entity and the beneficiaries for whose cost and quality of care the participating eligible clinicians are held accountable. These terms are the foundation for how we propose to count services furnished through an Advanced APM Entity.
We proposed that “attributed beneficiary” be defined as a beneficiary attributed to the Advanced APM Entity on the latest available list of attributed beneficiaries during the QP Performance Period based on each APM's respective attribution rules. There are some natural advantages to using this term for the purposes of QP determination because it is consistent with how many APMs—including the Shared Savings Program (assigned beneficiaries), Next Generation ACO Model (aligned beneficiaries), and BPCI Model (attributed beneficiaries)—identify the beneficiaries whose outcomes and costs are included in an APM Entity's assessment. We believe that using the same construct also coordinates the incentives under the Advanced APM with the incentives under the MACRA by addressing the same beneficiary population.
In most episode payment models, such as the CJR Model, attribution is defined by the beneficiaries who trigger the defined episode of care under the model, often by presenting with a specific condition at the location of a participating APM Entity. In many attribution-based APMs, such as ACO initiatives or the Comprehensive Primary Care Initiative, CMS attributes beneficiaries to APM Entities through claims-based algorithms that identify the APM Entity with the plurality of evaluation and management visits for a beneficiary. In addition, most APMs do not allow beneficiaries to be attributed to more than one APM Entity. This means that the greater the APM Entity density in a market, the lower the attributed population for a given APM Entity will be as a percent of its total beneficiaries. We solicited comment on the proposed methodology for defining the attributed beneficiary population, including comment on alternative methods for capturing the most meaningful cohort of attributed beneficiaries.
Under these plurality-based approaches, typically only 30-50 percent of an Advanced APM Entity's total population of beneficiaries for whom its eligible clinicians furnish services are actually attributed to the Advanced APM Entity for a performance period. These percentages reflect a combination of CMS' design decisions, beneficiaries' underlying care patterns, and the fact that beneficiaries in Medicare FFS retain freedom of choice to select clinicians. These percentages reflect conditions that are not entirely under the control of the APM Entity or its eligible clinicians. Thus, we recognize that because Advanced APMs have different attribution methodologies, using the specific Advanced APM attributed beneficiary as the definition may create a standard that advantages or disadvantages participation in certain Advanced APMs relative to others simply based on the specific attribution policies.
We proposed to use the attributed beneficiaries on Advanced APM attribution lists generated by each Advanced APM in making QP determinations. We also proposed that the attributed beneficiary list would be taken from the Advanced APM's latest available list at the end of the QP Performance Period prior to making the QP determinations. For episode payment models, attributed beneficiaries would be those beneficiaries who trigger episodes of care under the terms of the APM.
We believe that this approach to attribution lists maintains consistency with the panel of beneficiaries for whom Advanced APM Entities are responsible under their respective Advanced APMs during the QP Performance Period. Therefore, we believe that such lists would be appropriate for use in QP determinations. Advanced APM Entities are already accustomed to providing care for the panel of beneficiaries represented by their APM Entity-specific list. We believe that our proposal to link attribution for QP determination to Advanced APM attribution lists further strengthens the goals of the Advanced APMs in which these Advanced APM Entities participate. By using the same beneficiary population for QP determination purposes, Advanced APM Entities may continue focusing on the care they furnish to the same panel of attributed beneficiaries, instead of shifting focus and changing practice patterns to reach a QP threshold. As stated in our principles in section II.F.1. of the proposed rule (81 FR 28293), we intend for the QP determination process to seamlessly reward participation in Advanced APMs, not to create a new set of performance standards distinct from the goals of APMs.
We solicited comment on our proposal for determining which beneficiaries are considered attributed to an Advanced APM Entity.
The following is a summary of the comments we received regarding our proposal to define the attributed beneficiary population based on actual Advanced APM attribution and to use the latest available attribution list at the end of the QP Performance Period for QP determinations.
We are finalizing the definition of attributed beneficiary as proposed. We are finalizing that we would identify the attributed beneficiaries for an Advanced APM Entity based on the latest available attribution list at the time of a QP determination. This differs slightly from the proposed policy in order to align with the finalized QP Performance Period policies in this section and enable QP determinations to be made earlier in the QP Performance Period.
Consistent with our proposed definition of attributed beneficiary, our proposed definition for an attribution-eligible beneficiary would allow us to be consistent across Advanced APMs in how we consider the population of beneficiaries served by an Advanced APM Entity for the purposes of QP determination. To be attributed to an Advanced APM Entity in an Advanced APM, a beneficiary is first required to meet certain eligibility criteria. Specifically, for purposes of QP determinations, we propose that an attribution-eligible beneficiary would be one who:
(1) Is not enrolled in Medicare Advantage or a Medicare cost plan.
(2) Does not have Medicare as a secondary payer.
(3) Is enrolled in both Medicare Parts A and B.
(4) Is at least 18 years of age.
(5) Is a United States resident.
(6) Has a minimum of one claim for evaluation and management services by an eligible clinician or group of eligible clinicians within an APM Entity for any period during the QP Performance Period.
An attribution-eligible beneficiary may or may not be an attributed beneficiary. Attributed beneficiaries are a subset of attribution-eligible beneficiaries. Much like the term “attributed beneficiary,” the term attribution-eligible beneficiary is generally consistent with the attribution methodologies used in most current APMs to identify the beneficiaries who could potentially be attributed to an APM Entity. Although the factors we proposed for the definition of an attribution-eligible beneficiary in this context would only apply for the purposes of QP determinations, and would not change APM-specific methodologies, we believe that the factors in the proposed definition are representative of the methodologies most current APMs use to perform attribution. Therefore, we believe it would serve as a practical common set to apply in QP threshold calculations.
The purpose of using the attribution-eligible construct is to ensure that the denominator of QP determination calculations described in this section only includes payments for services furnished to patients who could potentially be attributed to an Advanced APM Entity under the Advanced APM, and thus could also appear in the numerator of the QP determination calculations. We believe that including amounts in the denominator that could not possibly be included in the numerator would be arbitrarily punitive toward certain Advanced APM Entities that furnish services to a substantial population of non-attribution-eligible beneficiaries.
We note that specialty-focused or disease-specific APMs may have attribution methodologies that are not based on evaluation and management services. Therefore, we anticipate needing targeted exceptions, especially related to the sixth factor of the definition of attribution-eligible beneficiary, for such APMs so that the attributed beneficiary population is truly a subset of the attribution-eligible population. Such exceptions would be made either through rulemaking or using available waiver authority and would be announced when the APM is announced.
For example, under the CEC Model, one criterion, among others, to be an aligned beneficiary requires that the beneficiary receive maintenance dialysis services. In the event that the CEC Model were determined to be an Advanced APM, we would consider
Although the availability of such exceptions, as outlined above, would create multiple standards for the beneficiaries that are attribution-eligible, we believe this slightly more complex approach is more appropriate and equitable because it is consistent with the design of APMs. An alternative approach could be to have a simple standard that includes in the denominator all beneficiaries who are furnished any Medicare Part B covered professional service by eligible clinicians participating in the Advanced APM Entity.
We solicited comment on the proposed general definition of attribution-eligible beneficiary and on our proposal to use of APM-specific standards as necessary to fulfill our expressed goals for specialty- or disease-focused APMs that may use alternative attribution methodologies.
The following is a summary of the comments we received regarding our proposal to define attribution-eligible beneficiaries.
We are finalizing the definition of attribution-eligible to mean a beneficiary who:
• Is not enrolled in Medicare Advantage or a Medicare cost plan.
• Does not have Medicare as a secondary payer.
• Is enrolled in both Medicare Parts A and B.
• Is at least 18 years of age.
• Is a United States resident.
• Has a minimum of one claim for evaluation and management services by an eligible clinician or group of eligible clinicians within an APM Entity for any period during the QP Performance Period.
We are also finalizing that, for Advanced APMs that do not base attribution on evaluation and management services and for which attributed beneficiaries are not, in fact, a subset the attribution-eligible beneficiary population based on the requirement to have at least one claim for evaluation and management services furnished by an eligible clinician who is in the APM Entity for any period during the QP Performance Period, then we will modify the definition of attribution-eligible beneficiary for that Advanced APM only in order to identify the appropriate attribution-eligible population based upon the attribution methodology of the Advanced APM (for example, a combination of evaluation and management services and/or other Part B covered professional services). We will announce these exceptions to the extent applicable in a manner consistent with the Advanced APM notification process under section II.F.4. of this final rule with comment period.
For example, we would develop such an exception for the CEC Model to the extent it is determined to be an Advanced APM to ensure that the denominator of QP determination calculations described in this section only includes payments for services furnished to patients who could potentially be attributed to ESRD Seamless Care Organizations (ESCOs).
This section describes how we will calculate a Threshold Score for the eligible clinician group in an Advanced APM Entity—or individual eligible clinician in the exception situations under section II.F.6. of this final rule with comment period—using the payment amount method, which would then be compared to the relevant QP Payment Amount Threshold and Partial QP Payment Amount Threshold to determine if the eligible clinician meets the QP status for a payment year.
For the payment amount method, sections 1833(z)(2)(A), (B)(i) and (C)(i) of the Act requires that we use payments for Medicare Part B covered professional services to make QP determinations. Covered professional services are defined under section 1848(k)(3)(A) of the Act as services for which payment is made under, or based on, the PFS. The payment amounts discussed in this proposal only include payments for Medicare Part B services under, or based on, the PFS, even if an Advanced APM bases attribution and/or financial risk on payments other than or in addition to Medicare Part B payments.
We proposed to use all available Medicare Part B claims information generated during the QP Performance Period. Additionally, we propose that CMS will treat claims run-out, claims adjustments, supplemental service payments, and alternative payment methods in the same manner for purposes of calculating both the Threshold Score and for determining the APM Incentive Payment amount. We further detailed our proposals to account for claims run-out, claims
We believe it is appropriate to maintain consistency across the QP determination and the incentive payment calculation in order to support internal CMS operational consistencies. It also ensures that any unique payment mechanisms within an Advanced APM do not affect the opportunity for an eligible clinician to reach the QP threshold.
We solicited comment on whether the claims methodology we use under the Medicare payment method should align with the proposed claims methodology for purposes of calculating the estimated aggregate payment amount for the APM Incentive Payment.
The following is a summary of the comments we received regarding our proposal for the QP payment amount method to use all available claims information for Medicare Part B covered professional services during the QP Performance Period and to treat claims run-out, claims adjustments, supplemental service payments, and alternative payment methods in the same manner as that used for the APM Incentive Payment calculation.
We are finalizing that for the QP payment amount method we will use all available claims information for Medicare Part B covered professional services during the applicable QP determination period as described in this section of the final rule with comment period.
In general, our method for deriving a Threshold Score for an Advanced APM Entity is to divide the value described under paragraph (a) in this section by the value described under paragraph (b) of this section. This calculation will result in a percent value that CMS will compare to the QP Payment Amount Threshold and the Partial QP Payment Amount Threshold to determine the QP status for all eligible clinicians in the Advanced APM Entity for the payment year.
We proposed that the numerator for this calculation would be the aggregate of all payments for Medicare Part B covered professional services furnished by the eligible clinicians in the Advanced APM Entity to attributed beneficiaries during the QP Performance Period.
We believe that this method is the most logical reading of the statute and is reflective of the population of beneficiaries for whom an Advanced APM Entity is responsible for cost and quality. Therefore, we believe that counting payments for covered professional services furnished to attributed beneficiaries is the most suitable metric for payments that are attributable to services furnished “through” an Advanced APM Entity. In episode payment models, because a beneficiary is considered attributed during the course of an episode, the payments included in the numerator for this calculation are those for Medicare Part B covered professional services furnished to an attributed beneficiary by eligible clinicians in the Advanced APM Entity during the course of an episode.
One program integrity concern is that an Advanced APM Entity might meet the higher QP Payment Amount Threshold in later years by providing substantially disproportionate amounts of care for attributed beneficiaries relative to all others. However, because of the financial risk an Advanced APM Entity bears, which is usually based on expenditures, we believe that the relatively large potential loss under the Advanced APM would outweigh the advantage of any overutilization geared toward abusing Threshold Score calculations. We solicited comment on any alternative numerators we could use for purposes of the Medicare payment method that meaningfully meet statutory requirements, are understandable, and operationally feasible.
The following is a summary of the comments we received regarding our proposal to calculate the numerator of the Threshold Score under the QP payment amount method using the aggregate of all payments for Medicare Part B covered professional services furnished by the eligible clinicians in the Advanced APM Entity to attributed beneficiaries during the QP Performance Period.
We are finalizing the numerator of the Threshold Score under the QP payment amount method to be the aggregate of all payments for Medicare Part B covered professional services furnished by the
This is identical to the proposed policy except that the applicable range of service dates will vary depending on which of the three QP determinations during a QP Performance Period is being performed in accordance with the finalized QP Performance Period policy in this section and illustrated in Figure G.
We proposed that the denominator in the Medicare payment method would be the aggregate of all payments for Medicare Part B covered professional services furnished by the eligible clinicians in the Advanced APM Entity to attribution-eligible beneficiaries during the QP Performance Period. We proposed that when the QP determination is made at the eligible clinician level as described in section II.F.5. of the proposed rule (81 FR 28313), the denominator would be the total of all payments for Medicare Part B covered professional services furnished to attribution-eligible beneficiaries by the eligible clinician. In episode payment models, the payments included in the denominator for this calculation as proposed would be those for Medicare Part B covered professional services furnished to any attribution-eligible beneficiary by eligible clinicians in the Advanced APM Entity. This would include all such services to all attribution-eligible beneficiaries whether or not such services occur during the course of an episode under the Advanced APM.
Including payment for services furnished only to attribution-eligible beneficiaries standardizes the denominator to ensure fairness across types of eligible clinicians and geographic regions. By using the attribution-eligible population, the denominator will not penalize entities for furnishing services to beneficiaries who could not possibly be in the numerator through attribution under an Advanced APM. For example, an ACO's eligible clinicians may furnish services to a large population of beneficiaries with Medicare as a secondary payer. Those beneficiaries may not be eligible for attribution to the ACO, and could never be included in the numerator. Therefore, we believe that this methodology focuses on factors for which Advanced APM Entities have some control rather than those for which they may have no control or that disadvantage certain organizational structures or types of APMs. We solicited comment on alternative methods that are consistent with the statutory language.
The following is a summary of the comments we received regarding our proposal to calculate the denominator of the Threshold Score for the QP payment amount method using the aggregate of all payments for Medicare Part B covered professional services furnished by the eligible clinicians in the Advanced APM Entity to attribution-eligible beneficiaries during the QP Performance Period.
We will closely monitor Threshold Scores, particularly with respect to the impact of specialist participation, the fragmentation of where beneficiaries seek their care, or circumstances such as high rates of “snowbird” patients affecting the denominator. We will monitor Threshold Scores at both the APM Entity and individual levels to understand how group Threshold Scores may vary based on characteristics of attributed beneficiary populations and the eligible clinicians in an Advanced APM Entity.
We believe that ACOs, which on average have specialist representation on their Participation Lists approximately representative of the specialist distribution nationally, will generally be able to meet the QP thresholds. We also believe that participation in any episode payment models that are Advanced APMs could be an opportunity, consistent with the relatively narrow scope of many episode payment models, for eligible clinicians to become a QP.
We are finalizing the denominator of the Threshold Score under the QP payment amount method to be the aggregate of all payments for Medicare Part B covered professional services furnished by the eligible clinicians in the Advanced APM Entity to attribution-eligible beneficiaries during the timeframe used for QP determination. This is identical to the proposed policy except that the applicable range of service dates will vary depending on which of the three QP determinations during a QP Performance Period is being performed in accordance with the finalized QP Performance Period policy in this section.
Similar to the Medicare payment amount method, this section describes our proposal for calculating a Threshold Score for the eligible clinicians participating in an Advanced APM Entity—or eligible clinician in situations under section II.F.6. of this final rule with comment period—using the Medicare patient count method, which would then be compared against the relevant QP Patient Count Threshold and Partial QP Patient Count Threshold to determine the QP status of an eligible clinician for the year. Given our authority under section 1833(z)(2)(D) of the Act to use patient counts in lieu of payments “as the Secretary determines appropriate,” we are interpreting the patient count method to offer a more flexible alternative to the payment method. As previously mentioned, the purpose of the proposed design of the Medicare patient count method is to make QP status determinations accessible to entities and individuals who are clearly and significantly engaged in delivering value-based care through participation in Advanced APMs.
We proposed that when counting the number of beneficiaries under this method, we may count a given beneficiary in the numerator and denominator for multiple different Advanced APM Entities or eligible clinicians.
We proposed that we would not count any beneficiary more than once for any single Advanced APM Entity or eligible clinician. In other words, for each Advanced APM Entity or eligible clinicians, we would count each unique beneficiary no more than one time in the numerator and one time in the denominator.
We believe that counting beneficiaries this way retains the integrity of the Threshold Scores by preventing double counting of beneficiaries within an Advanced APM Entity while recognizing the reality that beneficiaries often have relationships with multiple different organizations.
To be consistent with the Medicare payment method, we proposed that beneficiary counts would be based on any beneficiary for whom the eligible clinicians within an Advanced APM Entity receive payments for Part B covered professional services, or professional services furnished at an RHC or FQHC as described in this section, even if an Advanced APM bases its attribution and/or financial risk on both Parts A and B. We proposed that for this Threshold Score calculation, we would use any and all available Part B claims information generated during the QP Performance Period. We received no specific comments regarding our proposals to enable a beneficiary to be counted for multiple APM Entities but to count a beneficiary no more than once per APM Entity.
We are finalizing the policy for the Medicare patient count method to enable a beneficiary to be counted in the numerator and denominator for multiple APM Entities or eligible clinicians but to count a beneficiary no more than once in the numerator and once in the denominator per APM Entity or eligible clinician. We are also finalizing the policy to base patient counts on any beneficiary for whom the eligible clinicians within an Advanced APM Entity receive payments for Part B covered professional services, or professional services furnished at an RHC or FQHC as described in this section, and to use any and all available Part B claims information generated during the QP Performance Period.
We proposed that the Threshold Score would be calculated under the Medicare patient count method as a percent by dividing the value described under paragraph (a) of this section by the value described under paragraph (b) of this section. We include the formula and examples in the summary equation below.
We proposed that the numerator would be the number of unique attributed beneficiaries to whom eligible clinicians in the Advanced APM Entity furnish Medicare Part B covered professional services during the QP Performance Period. For episode payment models, this would include the number of attributed beneficiaries furnished Medicare Part B covered professional services, or professional services at an RHC or FQHC as described in this section, by eligible clinicians in the Advanced APM Entity during the course of an episode under the Advanced APM.
We did not receive any comments uniquely responding to our proposal for the numerator in the patient count method that were not also applicable to the payment amount method. Therefore, relevant comments were addressed in the payment amount numerator section.
We are finalizing the policy that the numerator of the Threshold Score for the QP patient count method will be the number of unique attributed beneficiaries to whom eligible clinicians in the Advanced APM Entity furnish Medicare Part B covered professional services, or professional services at an RHC or FQHC as described in this section, during the QP determination timeframe. For episode payment models, the numerator will be the number of attributed beneficiaries furnished Medicare Part B covered professional services by eligible clinicians in the Advanced APM Entity during the course of an episode under the Advanced APM. This policy is identical to the proposed policy except that the applicable range of service dates will vary depending on which of the three QP determinations during a QP Performance Period is being performed in accordance with the finalized QP Performance Period policy in this section.
We proposed that the denominator would be the number of attribution-eligible beneficiaries to whom eligible clinicians in the Advanced APM Entity furnish covered professional services during the QP Performance Period. For episode payment models, this would include the number of attribution-eligible beneficiaries furnished Medicare Part B covered professional services by eligible clinicians in the Advanced APM Entity group at any point during the QP Performance Period, irrespective of whether such services occur during the course of an episode.
We solicited comment on alternative approaches to the patient count method that would achieve our goal of a simple and meaningful Threshold Score calculation.
We did not receive any comments uniquely responding to our proposal for the denominator in the patient count method that were not also applicable to the payment amount method. Therefore, relevant comments were addressed in the payment amount denominator section.
We are finalizing the denominator of the Threshold Score under the QP patient count method to be the number of attribution-eligible beneficiaries to whom eligible clinicians in the Advanced APM Entity furnish covered professional services during the timeframe used for QP determination.
This is identical to the proposed policy except that the applicable range of service dates will vary depending on which of the three QP determinations during a QP Performance Period is being performed in accordance with the finalized QP Performance Period policy in this section. In general, we believe that through consistency with the payment amount method, this approach balances our interests of relative simplicity and having a meaningful standard that recognizes the common aspects of attribution and accountability under Advanced APMs. Similar to the payment amount method, the patient count method represents a proportion of the patients for whom an Advanced APM Entity is accountable under the Advanced APM with respect to all patients who could potentially be attributed to the Advanced APM Entity under the Advanced APM.
We proposed that if the same Advanced APM Entity participates in multiple Advanced APMs and if at least one of those Advanced APMs is an episode payment model, we would add the number of unique beneficiaries in the numerator of the episode payment model Advanced APM Entity to the numerator(s) for non-episode payment models in which the Advanced APM Entity participates. For example, if an Advanced APM Entity is an ACO in Track 3 of the Shared Savings Program and also in the OCM (assuming these are both Advanced APMs for purposes of this example), we would add the entity's unique attributed beneficiaries in OCM to the numerator for its Shared Savings Program Track 3 Threshold Score calculation. We proposed that for purposes of the APM incentive, Advanced APM Entities would be considered the same if we determine that the eligible clinician Participation Lists are the same or substantially similar, or if the Advanced APM Entity participating in one Advanced APM is the same as, or is a subset of, the other.
The purpose of this proposal was to allow the logical combination of activities under multiple Advanced APMs where appropriate. We believe that the purpose of the incentives for Advanced APM participation is to capture the degree of Advanced APM participation generally, not simply the degree of participation within a single Advanced APM. Where relevant and operationally feasible, we want this program to encourage participation in multiple Advanced APMs. The counterfactual where we would not account for a single Advanced APM Entity's participation in multiple Advanced APMs could be seen as punitive. For instance, an Advanced APM Entity could serve the vast majority of its beneficiaries through several Advanced APMs, but unless that participation is aggregated, the entity could end up with several lower Threshold Scores that are below the QP Patient Count Threshold and not indicative of its broader participation.
We understand the difficulty associated with determining whether two Advanced APM Entities are in fact the same organization. It is highly unlikely that their Participation Lists would be exactly the same. Therefore, we solicited comment on how best to make a determination of substantial similarity, which includes, for example, matching organizational information, aligning TINs, and comparing Participation Lists. We also solicited comment on percentages of Participation List or TIN similarity that would be sufficient for APM Entities to be considered under this policy.
The following is a summary of the comments we received regarding our proposal that if the same Advanced APM Entity participates in multiple Advanced APMs and if at least one of those Advanced APMs is an episode payment model, we would add the number of unique beneficiaries in the numerator of the episode payment model Advanced APM Entity to the
After considering the comments and the difficulty of implementing this policy as proposed, we are not finalizing the proposed policy to combine the numerators of Advanced APM Entities that participate in multiple Advanced APMs with substantially similar Participation Lists. We do not believe that we have a reliable, precise mechanism for determining substantial similarity of Participation Lists. Further, we believe that the policy we finalized earlier in this section regarding how we would assess eligible clinicians who are in multiple Advanced APMs serves the intended purpose of this proposed policy because it gives an eligible clinician the opportunity to become a QP in the event that the eligible clinician does not become a QP through any one of the multiple Advanced APMs in which the eligible clinician participates. Therefore, we do not believe that our reconsideration of this policy will limit the opportunity of eligible clinicians to become QPs, and we believe that not finalizing this policy will promote operational and conceptual simplicity.
We proposed that we would calculate Threshold Scores for eligible clinicians in an Advanced APM Entity under both the payment amount and patient count methods for each QP Performance Period. We also proposed that we would assign QP status using the more advantageous of the Advanced APM Entity's two scores.
We believe that both the payment amount and patient count methods produce valid Threshold Scores, even as there may be cases in which Threshold Scores vary enough that different QP determinations could result depending on which is used. In such an event, we do not believe that prioritizing the Threshold Score using one calculation over the other would yield an appropriate, non-arbitrary result. By using the more advantageous of the Threshold Scores achieved, we hope to promote simplicity in QP determinations and to maximize the number of eligible clinicians that attain QP status each year. We solicited comment on the use of the payment and patient count methods for the Medicare Option.
The following is a summary of the comments we received regarding our proposal to calculate for each Advanced APM Entity of eligible clinician the Threshold Score using both the payment amount and patient count methods and use the more advantageous of the two scores.
We are finalizing the policy as proposed. We will calculate Threshold Scores for each Advanced APM Entity or eligible clinician using both the payment amount and patient count methods and apply the more advantageous QP result.
To clarify the meaning of “more advantageous,” we mean that a QP determination takes precedence over a Partial QP determination, which takes precedence over not meeting either threshold. Therefore, if one method results in a QP determination and the other results in a Partial QP determination, we would apply the QP determination and disregard the Partial QP determination. We note that this is distinct from the numerical score, which is not directly comparable across the payment amount and patient count methods due to the different percentage thresholds for the respective methods. A lower numerical patient count Threshold Score may actually result in a more advantageous QP result than a relatively higher numerical payment amount Threshold Score.
We proposed that professional services billed by CAHs under section 1834(g)(2)(B) of the Act (Method II CAH professional services) would count towards the QP determination threshold calculations for both the Medicare payment amount and patient count methods in both the numerator and the denominator, as applicable. These services would constitute “covered professional services” under section 1848(k)(3) of the Act because they are furnished by an eligible clinician and payment is based on the Medicare PFS. This policy is consistent with our treatment of payments for Method II CAH professional services for purposes of the EHR Incentive Program and PQRS adjustments under sections 1848(a)(7) and (8) of the Act, respectively. Under section 1848(a)(7) and (8) of the Act, the PQRS and EHR Incentive Program adjustments are applied to payments for covered professional services furnished by an eligible clinician in a Method II CAH.
CAHs were established under the Balanced Budget Act (BBA) of 1997 as a separate provider type with a distinct set of Medicare Conditions of Participation and their own payment methodology. CAHs are not subject to the Medicare Inpatient Prospective Payment System (IPPS) or the Medicare Outpatient Prospective Payment System (OPPS). Instead, CAHs are generally paid based on 101 percent of reasonable costs for inpatient services and are paid for outpatient services under one of two methods: the Standard Payment method outlined in section 1834(g)(1) of the Act (Method I), or the Optional Payment Method outlined in section 1834(g)(2) of the Act (Method II). A CAH is paid under Method I unless it elects to be paid under Method II.
Under Method I, for cost reporting periods beginning on or after January 1, 2004, payments to CAHs are made for outpatient CAH facility services at 101 percent of reasonable costs. Physicians and practitioners receive payment for professional services under the Medicare PFS. A CAH may elect Method II billing, under which the CAH bills Medicare for both facility services and professional services furnished to its outpatients by a physician or
As of January 1, 2004, payment for a physician's professional services provided at a CAH billing under Method II is 115 percent of the allowed amount, after applicable deductions, under the Medicare PFS. For a non-physician practitioner's professional services, the payment amount is 115 percent of the amount that otherwise would be paid for the practitioner's professional services, after applicable deductions, under the Medicare PFS.
RHCs and FQHCs are facilities that furnish services that are typically furnished in an outpatient clinic setting. They are located in areas that have been designated as underserved or health professional shortage areas (HPSAs), and meet other requirements.
Under section 1833(a)(3) of the Act, RHCs are paid an all-inclusive rate (AIR) based on reasonable costs, subject under section 1833(f) of the Act to a maximum payment per visit that is established by Congress and updated annually based on the percentage change in the Medicare Economic Index (MEI) and subject to annual reconciliation. The per-visit limit does not apply to RHCs determined to be an integral and subordinate part of a hospital with fewer than 50 beds. Laboratory tests (excluding venipuncture) and technical components of RHC services are paid separately. The RHC payment limit per visit for CY 2016 is $81.32, effective January 1, 2016, through December 31, 2016.
The FQHC Medicare benefit was added when section 1861(aa) of the Act was amended by section 4161 of the Omnibus Budget Reconciliation Act of 1990. FQHCs are paid according to the FQHC PPS set out under section 1834(o) of the Act, in which Medicare pays a national encounter-based rate per beneficiary per day, with some adjustments. The unadjusted 2016 PPS rate is $160.60.
We proposed that professional services furnished at RHCs and FQHCs that participate in ACOs, and are reimbursed under the RHC AIR or FQHC PPS (respectively), be counted towards the QP determination calculations under the patient count method but not under the payment amount method.
In certain Medicare ACO APMs, RHC and FQHC services can be counted for purposes of attributing beneficiaries to an ACO. Therefore, we proposed to include beneficiaries attributed to an Advanced APM Entity in full or in part because of services furnished by RHCs or FQHCs in the patient counts used for QP determination calculations.
As previously stated, section 1833(z)(2)(D) of the Act permits us to use patient counts in lieu of payments when determining whether an eligible clinician is a QP “as the Secretary determines appropriate.” Our proposal to include the professional services furnished by eligible clinicians at RHCs and FQHCs in the QP threshold calculations for the patient count method is essential to assure consistency with this program and existing APM attribution methodologies. An Advanced APM Entity is responsible for the cost and quality of care for all beneficiaries attributed to an APM Entity, including all professional services furnished to such beneficiaries, regardless of whether or not attribution was based on services furnished by an eligible clinician or by an RHC or FQHC. We believe such beneficiaries are clearly served through the Advanced APM Entity, and it would be potentially confusing to eligible clinicians and Advanced APM Entities to track this distinction strictly for purposes of QP determination. We also believe that it would be unduly burdensome and impractical for us to develop and maintain a separate list of beneficiaries aligned to each Advanced APM Entity from the full list of beneficiaries for whom an Advanced APM Entity is responsible under an Advanced APM.
Because professional services furnished by eligible clinicians at RHCs and FQHCs are not reimbursed under, or based on, the Medicare PFS, professional services furnished in these settings do not constitute “covered professional services” under section 1848(k)(3)(A) of the Act. In the Medicare Payment Amount Method, where payments for specified covered professional services are summed, only payments for covered professional services can be included.
We believe that our proposal will continue to encourage the development of APMs that span rural and/or underserved areas. We solicited comment on this proposal.
The following is a summary of the comments we received regarding our proposal to (1) include payments for Method II CAH professional services furnished by eligible clinicians in an Advanced APM Entity in the numerator of the Threshold Score for the payment amount method and (2) to allow Method II CAH professional services furnished by eligible clinicians in an Advanced APM Entity and professional services furnished by eligible clinicians in an Advanced APM Entity at RHCs and FQHCs to place a beneficiary in the numerator of the Threshold Score for the patient count method.
We are finalizing the policy as proposed. We will include payments for Method II CAH professional services furnished by eligible clinicians in an Advanced APM Entity in the numerator of the Threshold Score for the payment amount method. We will also count a beneficiary in the numerator of the Threshold Score for the patient count method if the beneficiary receives Method II CAH professional services furnished by eligible clinicians in an Advanced APM Entity and professional services furnished by eligible clinicians in an Advanced APM Entity at RHCs and FQHCs.
Beginning in 2021, in addition to the Medicare Option, eligible clinicians may alternatively become QPs through the All-Payer Combination Option, described under section 1833(z)(2)(B)(ii) and (C)(ii) of the Act as the Combination All-Payer and Medicare Payment Threshold Option. Thus, there will be two avenues for eligible clinicians to become QPs—the Medicare Option and the All-Payer Combination Option. An eligible clinician need only meet the QP threshold under one of the two options to be a QP for the payment year. The All-Payer Combination Option provides an incentive for eligible clinicians to participate in payment arrangements with payers other than Medicare Part B that have payment designs similar to Advanced APMs. The All-Payer Combination Option uses both the methods described in the Medicare Option and methods that calculate payments for all services from all payers, with certain exceptions, that are attributable to participation in both Advanced APMs and Other Payer Advanced APMs.
Although the statutory QP threshold for an eligible clinician to be a QP (the QP Payment Amount Threshold) under the Medicare Option increases from 25 percent in 2019 and 2020 under section 1833(z)(2)(A) of the Act, to 50 percent in 2021 and 2022 under section 1833(z)(2)(B)(i) of the Act, to 75 percent beginning in 2023 under section 1833(z)(2)(C)(i) of the Act, the All-Payer Combination Option allows eligible clinicians with lower levels of participation in Advanced APMs to become QPs through sufficient participation in Other Payer Advanced APMs with payers such as State Medicaid programs and commercial payers, including Medicare Advantage plans. Section 1833(z)(2)(D) of the Act also allows the QP determination to be based on payment amount or on counts of patients in lieu of payments using the same or similar percentage criteria. These QP thresholds are presented in Tables 36 and 37 of this final rule with comment, and the process for the payment amount method is shown in Figures H and I of this final rule with comment. We may reassess the QP Patient Count Thresholds in future years based on the experience gained during the first years of operations.
In summary, in addition to becoming QPs through the Medicare Option, eligible clinicians may alternatively become QPs through the All-Payer Combination Option if the following steps occur as described in the associated sections of the proposed rule: (1) the eligible clinician submits to CMS sufficient information on all relevant payment arrangements with other payers; (2) based upon that information CMS determines that at least one of those payment arrangements is an Other Payer Advanced APM; (3) the eligible clinician meets the relevant QP thresholds by having sufficient payments or patients attributed to a combination of participation in Other Payer Advanced APMs and Advanced APMs.
Sections 1833(z)(2)(B)(ii) and (C)(ii) of the Act describe the payment amount method for making the QP determination under the All-Payer Combination Option. For purposes of making a QP determination under this option, a QP is an eligible clinician for whom it is determined that items and services furnished by such a professional during the most recent period for which data are available (which may be less than a year) and where the specified percent of the sum of combined Medicare payments and all other payments regardless of payer are through Advanced APMs and Other Payer Advanced APMs that meet the criteria set forth in this section.
The following is a summary of the comments we received regarding our overall approach to the All-Payer Combination Option.
By contrast, one commenter expressed concern about extending Advanced APMs to other payer arrangements by identifying Other Payer Advanced APMs. Another commenter noted we have historically emphasized the importance of engaging multiple payers in payment reform, but has never suggested that commercial payers must offer identical arrangements to those CMS offers or replicate CMS payment models. One commenter opposed using the same criteria to determine both Advanced APM and Other Payer Advanced APMs, noting that these criteria would require large-scale renegotiation of payer contracts, which may not be within an organization's control. One commenter recommended CMS abandon the All-Payer
Another commenter recommended that CMS establish a process to approve state-operated APMs so that clinicians can be aware of which payment arrangements will be Other Payer Advanced APMs. One commenter believes CMS needs to clearly articulate a process for how it will determine Other Payer Advanced APMs in states that are engaged with CMS in the development of Other Payer Advanced APMs.
One commenter supported the proposal to assess Medicaid APMs under the Other Payer Advanced APM criteria and to include the Medicaid APM as part of the All-Payer Combination Option. This commenter agreed that CMS should generally defer to states in their design of these payment arrangements. The commenter also agreed with the proposal that if a state does not offer a Medicaid APM that meets the Other Payer Advanced APM criteria, then Medicaid payments and patients would be excluded from the All-Payer Combination Option calculations. Another commenter supported the criteria for Other Payer Advanced APMs and recommended including Medicare Advantage and state programs created through the Medicaid Health Home State Plan Option in the All-Payer Combination Option calculations.
After considering public comments, we are finalizing our overall approach to the All-Payer Combination Option as proposed. We are seeking additional comments on the creation of an optional pathway for states to seek a determination from CMS on whether a Medicaid payment arrangement is an Other Payer Advanced APM. We are also seeking additional comments on the overall process for reviewing payment arrangements in order to determine whether they are Other Payer Advanced APMs.
According to section 1833(z)(2)(B)(iii) of the Act, a payment arrangement is an Other Payer Advanced APM if it meets three criteria:
• CEHRT is used;
• Quality measures comparable to measures under the MIPS quality performance category apply; and
• The payment arrangement either: (1) requires APM Entities to bear more than nominal financial risk if actual aggregate expenditures exceed expected aggregate expenditures; or (2) for beneficiaries under title XIX, is a Medicaid Medical Home Model that meets criteria comparable to Medical Home Models expanded under section 1115A(c) of the Act.
Payment arrangements under any payer other than traditional Medicare, including Medicare Advantage and other Medicare-funded private plans, will be Other Payer Advanced APMs if they meet all three criteria.
We proposed to define a Medicaid APM as a payment arrangement under title XIX that meets the criteria to be an Other Payer Advanced APM as proposed. States can choose from different authorities in title XIX when implementing new payment models. We believe this proposal would provide some flexibility for States but align the core requirements for Medicaid APMs with the broader Advanced APM and Other Payer Advanced APM criteria. Otherwise, we intend to generally defer to states in their design of payment arrangements.
We proposed that a Medicaid Medical Home Model is a Medical Home Model that is operated under title XIX instead of under section 1115A of the Act. We specifically identified Medicaid Medical Home Models because section 1833(z) of the Act mentions both medical homes generally and medical homes for beneficiaries under title XIX several times, but does not define the terms. Medicaid Medical Home is also not defined in title XIX or in Medicaid laws or regulations. Therefore, we needed to define the terms because of their importance in the Quality Payment Program. This definition of Medicaid Medical Home Model applies only for the purposes of the Quality Payment Program. We proposed that a Medicaid Medical Home Model must have the following elements at a minimum:
• Model participants include primary care practices or multispecialty practices that include primary care physician and practitioners and offer primary care services, and
• Empanelment of each patient to a primary clinician.
In addition to these elements, we proposed that a Medicaid Medical Home Model must have at least four of the following elements:
• Planned chronic and preventive care.
• Patient access and continuity.
• Risk-stratified care management.
• Coordination of care across the medical neighborhood.
• Patient and caregiver engagement.
• Shared decision-making.
• Payment arrangements in addition to, or substituting for, FFS payments (for example, shared savings, population-based payments).
This definition of Medicaid Medical Home Model applies only for the purposes of the Quality Payment Program, and could be defined differently for other purposes. To define these terms, we reviewed existing and
We solicited comment on the proposed definitions of Medicaid APMs and Medicaid Medical Homes Models.
The following is a summary of the comments we received regarding our definitions of Medicaid APMs and Medicaid Medical Home Models. Additional comments on the definition of Medicaid Medical Home Models were considered as part of the response to the definition of Medical Home Models in section II.F.3. of this final rule with comment period.
Several commenters believed CMS should provide states flexibility in designing and implementing their Medicaid Medical Home Models. One commenter suggested the rule should enable states to deem and define their own patient-centered medical home programs and determine if it is a Medicaid Medical Home Model. Another commenter recommended that Other Payer Advanced APMs should include state-sponsored patient-centered medical home models that have demonstrated improvements in cost, quality, and patient experience through an evaluative process. Another commenter recommended CMS permit greater flexibility in enabling Medicaid Medical Home Models to qualify as Other Payer Advanced APMs. One commenter recommended state-based medical homes models should be considered Other Payer Advanced APMs.
One commenter recommended CMS recognize robust regional programs when assigning credit for nationally recognized medical home models. Another commenter recommended that the proposed Medicaid Medical Home Model definition be expanded to include partnerships across sectors designed to improve population health and achieve health equity.
One commenter recommended that CMS require Other Payer Advanced APMs to meet all of the proposed primary care practice criteria and characteristics required of Medical Home Models.
To be an Other Payer Advanced APM, as described under section 1833(z)(2)(B)(iii)(II)(bb) and (z)(2)(C)(iii)(II)(bb) of the Act, payments must be made under arrangements in which CEHRT is used. This requirement is slightly different than the requirement for Advanced APMs that “requires participants in such model to use certified EHR technology (as defined in section 1848(o)(4) of the Act),” as specified in section 1833(z)(3)(D)(i)(I) of the Act. Although the statutory requirements are phrased slightly differently, we believe that there is value in keeping the two standards—for Advanced APMs and Other Payer Advanced APMs—as similar as possible.
We proposed that payment arrangements would meet this Other Payer Advanced APM criterion under sections 1833(z)(2)(B)(iii)(II)(bb) and (z)(2)(C)(iii)(II)(bb) of the Act by requiring participants to use CEHRT as defined for MIPS and APMs under § 414.1305. This approach is consistent with the approach for Advanced APMs as described in section II.F.4.b.(1) of this final rule with comment period. In the 2015 EHR Incentive Programs final rule (80 FR 62872 through 62873), we established the definition of CEHRT for EHR technology that must be used by eligible clinicians to meet the meaningful use objectives and measures in specific years. In the proposed rule, we proposed to adopt the specifications from within the current definition of CEHRT in our regulation at § 414.1305 for eligible clinicians participating in MIPS or in APMs. This definition is identical to the definition for use by eligible hospitals and CAHs and Medicaid eligible clinicians in the EHR Incentive Programs.
In accordance with section 1833(z)(2)(C)(iii)(II) of the Act, we proposed that an Other Payer Advanced APM must require at least 75 percent of eligible clinicians in each participating APM Entity (or each hospital if hospitals are the APM participants) to use the certified health IT functions outlined in the proposed definition of CEHRT to document and communicate
We solicited comment on the proposed definition of CEHRT for Advanced APMs and Other Payer Advanced APMs and whether they should be the same for both. We solicited comment on the proposed method for Other Payer Advanced APMs to meet the CEHRT use criterion.
The following is a summary of the comments we received regarding our proposal to require a payment arrangement to use CEHRT in order to become an Other Payer Advanced APM.
An additional commenter stated CMS should not dictate which edition of CEHRT must be included in a third party contract. Likewise, the commenter stated that CMS should not lock in a level of participation at this time, but instead monitor the performance and make a determination in a later rule. Another commenter expressed concern about an increased EHR burden on clinicians because of the cost of implementing the technology. One commenter recommended a requirement that Other Payer Advanced APMs meet all measures that currently exist in Meaningful Use standards, including access to discrete records, reference disease registries, receive care alerts, provide decision support, have access to lab results, and support a patient portal.
After considering public comments, we are modifying our proposal and finalizing that to be an Other Payer Advanced APM, a payment arrangement must require at least 50 percent of participating eligible clinicians in each APM Entity to use CEHRT to document and communicate clinical care.
Sections 1833(z)(2)(B)(ii)(II)(aa) and (C)(iii)(II)(aa) of the Act specify that, to be an Other Payer Advanced APM, a payment arrangement must apply quality measures comparable to those under the MIPS quality performance category. We proposed that the quality measures on which the Other Payer Advanced APM bases payment must include at least one of the following types of measures provided that they have an evidence-based focus and are reliable and valid:
(1) Any of the quality measures included on the proposed annual list of MIPS quality measures;
(2) Quality measures that are endorsed by a consensus-based entity;
(3) Quality measures developed under section 1848(s) of the Act;
(4) Quality measures submitted in response to the MIPS Call for Quality Measures under section 1848(q)(2)(D)(ii) of the Act; or
(5) Any other quality measures that CMS determines to have an evidence-based focus and are reliable and valid.
We proposed that not all quality measures in an APM are required to be “MIPS comparable” and not all payments under the APM must be based on comparable measures. This approach is similar to the requirement for Advanced APMs as described in section II.F.4.b.(2) of this final rule with comment period. We believe that under the proposed policy, Other Payer Advanced APMs would retain sufficient freedom to innovate in paying for services and measuring quality. In other words, this criterion only sets standards for payments tied to quality measurement, not other methods of payment. Conversely, a payment arrangement may test new quality measures that do not fall into the MIPS-comparable standard. So long as the payment arrangement meets the requirements set forth in this criterion, there is no additional prescription for how the payment arrangement tests additional measures that may or may not meet the standards under this criterion.
We want to encourage the use of outcome measures for quality performance assessment in Other Payer Advanced APMs, so we also proposed that an Other Payer Advanced APM must include at least one outcome measure if an appropriate measure (that is, the measure addresses the specific patient population and is specified for the participants' clinical setting) is available on the MIPS list of measures for that specific QP Performance Period.
We believe that this framework will provide other payers the flexibility needed to ensure that their quality performance metrics meet their unique goals. We solicited comment on this proposed criterion.
The following is a summary of the comments we received regarding our proposal that an Other Payer Advanced APM must provide for payment for covered professional services to include quality measures comparable to MIPS measures under the performance category.
After considering public comments, we are finalizing our proposal without changes. To be an Other Payer Advanced APM, a payment arrangement must base payment on quality measures that are evidence-based, reliable, and valid. At least one such measure must be an outcome measure unless there is not an applicable outcome measure on the MIPS quality measure list for the QP Performance Period. The outcome measure used does not have to be one of those on the MIPS quality measure list.
As described in sections 1833(z)(2)(B)(iii)(II)(cc) and (C)(iii)(II)(cc) of the Act, the third criterion that a payment arrangement must meet to be an Other Payer Advanced APM is that under the arrangement, the APM Entity must either bear more than nominal financial risk if actual aggregate expenditures exceed expected aggregate expenditures or the arrangement is a Medicaid Medical Home Model that meets criteria comparable to Medical Home Models expanded under section 1115A(c) of the Act.
The financial risk standard under this criterion is similar to the criterion we are finalizing for Advanced APMs. For purposes of determining whether the payment arrangement is an Other Payer Advanced APM, this proposal does not impose any additional performance criteria, such as actual achievement of savings, on APM Entities in other payer arrangements. As with all of the Advanced APM criteria, this requirement pertains to the payment arrangement structure, not to the performance of the participants within the payment arrangement.
This section is divided into two main parts: (1) What it means for an APM Entity to bear financial risk if actual aggregate expenditures exceed expected aggregate expenditures under a payment arrangement; and (2) what amounts of risk are considered to be more than nominal.
We proposed a generally applicable standard for Other Payer Advanced APMs and a slightly different standard for Medicaid Medical Home Models. We want to be consistent with and comparable to the Advanced APM financial risk standard within the limits of the statute.
We proposed that the generally applicable financial risk standard for Other Payer Advanced APMs would be that a payment arrangement must, if APM Entity actual aggregate expenditures exceed expected aggregate expenditures during a specified performance period:
• Withhold payment for services to the APM Entity and/or the APM Entity's eligible clinicians;
• Reduce payment rates to the APM Entity and/or the APM Entity's eligible clinicians; or
• Require direct payments by the APM Entity to the payer.
We believe this financial risk criterion best distinguishes most payment arrangements from those that are focused on challenging physicians and practitioners to assume risk and provide high value care. We expect that an increasing proportion of other payer arrangements will meet that bar over time. This proposal is based on the statutory requirement that the APM Entity bear risk if aggregate actual expenditures exceed aggregate expected expenditures under the model, and is consistent with our proposal for the corresponding criterion proposed for Advanced APMs. We understand that many stakeholders believe that business risk should be sufficient to meet this Advanced APM criterion. We do not intend to minimize the substantial time and financial commitments that APM Entities invest to become successful APM participants. We note that there is also difficulty in creating an objective and enforceable standard for determining whether an entity's business risk exceeds a nominal amount, and that the statutory framework for the APM Incentive Payment recognizes that not all alternative payment arrangements will meet the criteria to be considered for purposes of the QP determination. We solicited comments regarding the proposed standard and whether there are other types of arrangements that should be incorporated into the standard.
The following is a summary of the comments we received regarding our proposal to set a generally applicable Other Payer Advanced APM financial risk standard.
After considering public comments, we are finalizing our proposal to set a generally applicable Other Payer Advanced APM financial risk standard, as proposed, without changes. The generally applicable financial risk standard for Other Payer Advanced APMs is that, if the APM Entity's actual aggregate expenditures exceed expected aggregate expenditures during a specified performance period, the payer will:
• Withhold payment for services to the APM Entity and/or the APM Entity's eligible clinicians;
• Reduce payment rates to the APM Entity and/or the APM Entity's eligible clinicians; or
• Require direct payments by the APM Entity to the payer.
We proposed that for a Medicaid Medical Home Model to be an Other Payer Advanced APM if the APM Entity's actual aggregate expenditures exceed expected aggregate expenditures, the Medicaid Medical Home Model must:
• Withhold payment for services to the APM Entity and/or the APM Entity's eligible clinicians;
• Reduce payment rates to the APM Entity and/or the APM Entity's eligible clinicians;
• Require direct payment by the APM Entity to the Medicaid program; or
• Require the APM Entity to lose the right to all or part of an otherwise guaranteed payment or payments.
For instance, a Medicaid Medical Home Model would meet our proposed financial risk criterion if it conditions the payment of some or all of a regular care management fee to medical home APM Entities upon expenditure performance in relation to a benchmark. Because the arrangement would require no direct payment as a consequence for failure to meet expenditure standards, such a medical home would not necessarily be worse off than it had been prior to the decreased payment. However, it would be worse off in the future than it otherwise would have been had it met expenditure standards. Similarly, a Medicaid Medical Home Model that offers expenditure and quality performance payments in addition to payment withholds that can be earned back for meeting minimum requirements would also meet this criterion. Consistent with the treatment of Medical Home Models under the statute, this proposal acknowledges the unique challenges of medical homes in bearing risk for losses while maintaining a more rigorous standard than mere business risk.
We believe that because Medicaid Medical Home Models are unique types of Medicaid APMs and because they are identified and treated differently under the statute, it is appropriate to establish a unique standard for bearing financial risk that reflects these differences and
Similar to Medical Home Model standards for Advanced APMs, which are discussed in II.F.4.b.(3) of this final rule with comment period, we believe that it would be appropriate to impose size and composition limits for Medicaid Medical Home Models to ensure that the focus is on organizations with a limited capacity for bearing the same magnitude of financial risk as larger organizations do, namely, small primary care-focused organizations. We proposed that this limit would only apply to APM Entities that participate in Medicaid Medical Home Models and that have 50 or fewer eligible clinicians in the organization through which the APM Entity is owned and operated. Thus, in a Medicaid Medical Home Model that is an Other Payer Advanced APM, only those APM Entities that are part of a parent organization with 50 or fewer eligible clinicians would be APM Entities. We believe it is appropriate to use eligible clinicians, rather than physicians, when setting this threshold as the number of eligible clinicians both reflects organizational resources and capacity and also may differ substantially across organizations with the same number of physicians.
We also believe that this size threshold of 50 eligible clinicians is appropriate as organizations of that size have demonstrated the capacity and interest in taking on risk, and organizations may also join together to take on risk collectively, for example, in an ACO. In the event that a Medicaid Medical Home Model happens to have criteria that meet the Advanced APM financial risk criterion that is generally applicable to all Other Payer Advanced APMs, this organizational size limitation would be moot.
There are several unique aspects of Medicaid Medical Home Models, which statute specifically singles out for unique treatment, and their participating APM Entities (medical homes) that support the need for a separate standard to assess financial risk if actual expenditures exceed expected expenditures. Medical homes are generally more limited in their ability to bear financial risk than other entities because they tend to be smaller and predominantly include primary care practitioners, whose revenues are a smaller fraction of the beneficiaries' total cost of care than those of other eligible clinicians. Moreover, Medicaid medical home practices serve low income populations and those with significant health disparities; due to the method of payment for care for these populations, Medicaid medical home practices often have relatively low revenues. Lastly, Medicaid Medical Home Models to date have not required participants to bear substantial downside risk, and including such a requirement under this program would create a significant challenge for medical homes to serve their patients.
We solicited comment on the proposed financial risk standard set forth for Medicaid Medical Home Models and on alternative standards that would be consistent with the statute and could achieve our stated goals. We also solicited comment on types of financial risk arrangements that may not be clearly captured in this proposal.
The following is a summary of the comments we received regarding our proposal for the Medicaid Medical Home Model financial risk standard. Comments on the 50 eligible clinician size limit are aggregated in the comments on the correlating Medical Home Model financial risk criterion in section II.F.4. of this final rule with comment period.
Another commenter recommended that Medicaid Medical Home Models not be subjected to downside risk unless and until it can be clearly demonstrated generally that they are capable or caring for patients without any decrease in access or quality under the limited payments provided by Medicaid in most states. An additional commenter recommended CMS eliminate the nominal risk requirements for Medicaid Medical Home Models. By definition, physicians who treat Medicaid and dual eligible patients are assuming more than nominal financial risk, given the very low reimbursement rates.
One commenter stated that the financial risk standard needs to be revised to ensure that Medicaid medical homes serving vulnerable populations are not forced to assume financial risks that would jeopardize patients' access to care. Another commenter agreed that APM Entities should bear the financial risk, but noted that special considerations may be appropriate for Medicaid Medical Home Models depending on size as some FQHCs, RHCs, and Tribal 638 safety net clinics may be smaller with more diverse group of primary care practitioners. The same commenter noted that CMS has historically allowed states to implement APMs for FQHC/RHCs from the traditional PPS method, and requested CMS specifically address how states' models that include FQHCs and RHCs would be assessed to meet the Other Payer Advanced APM criteria.
We are also finalizing certain provisions at section II.F.6.d. of this final rule with comment period to ensure that CAH, RHC and FQHC participation in Advanced APMs is considered to the extent applicable when calculating Threshold Scores under the patient count method.
After considering public comments, we are finalizing our proposal for the Medicaid Medical Home Model financial risk standard without changes. The Medicaid Medical Home Model financial risk standard is that, if the APM Entity's actual aggregate expenditures exceed expected aggregate expenditures during a specified performance period, the payer will:
• Withhold payment for services to the APM Entity and/or the APM Entity's eligible clinicians;
• Reduce payment rates to the APM Entity and/or the APM Entity's eligible clinicians;
• Require direct payment by the APM Entity to the Medicaid program; or
• Require the APM Entity to lose the right to all or part of an otherwise guaranteed payment or payments.
When an other payer risk arrangement meets the proposed financial risk standard, we would then consider whether the risk is of a more than nominal amount such that it meets this nominal amount standard. Similar to the financial risk portion of this assessment, we proposed to adopt a generally applicable nominal amount standard for Other Payer Advanced APMs and a unique nominal amount standard for Medicaid Medical Home Models.
We proposed to measure three dimensions of risk to determine whether a payment arrangement meets the nominal amount standard: (a) Marginal risk, which is a common component of risk arrangements—particularly those that involve shared savings—that refers to the percentage of the amount by which actual expenditures exceed expected expenditures for which an APM Entity would be liable under a payment arrangement; (b) minimum loss rate (MLR), which is a percentage by which actual expenditures may exceed expected expenditures without triggering financial risk; and (c) total potential risk, which refers to the maximum potential payment for which an APM Entity could be liable under a payment arrangement. An example of marginal risk is an ACO that has a sharing rate, or marginal risk, of 50 percent and exceeds its benchmark (expected expenditures) by $1 million, the ACO would be liable for $500,000 of those losses. The marginal risk could also vary with the amount of losses.
To determine whether a payment arrangement satisfies the total risk portion of the nominal amount standard, we would identify the maximum potential payment an APM Entity could be required to make as a percentage of the expected expenditures under the payment arrangement. If that percentage exceeded the required total risk percentage, then the arrangement would satisfy the total risk portion of the nominal amount standard.
To determine whether a payment arrangement satisfies the marginal risk portion of the nominal amount standard, we would examine the payment required under the payment arrangement as a percentage of the amount by which actual expenditures exceeded expected expenditures. We proposed that we would require that this percentage exceed the required marginal risk percentage regardless of the amount by which actual expenditures exceeded expected expenditures, with two exceptions.
First, we proposed a maximum allowable “minimum loss rate” (MLR) of 4 percent in which the payment required by the payment arrangement could be smaller than the nominal amount standard would otherwise require when actual expenditures exceed expected expenditures by less than 4 percent; this exception accommodates payment arrangements that include zero risk for small losses but otherwise satisfy the marginal risk standard. We also proposed a process through which we could determine that a risk arrangement with an MLR higher than 4 percent could meet the nominal amount standard, provided that the other portions of the nominal amount standard are met. In determining whether such an exception would be appropriate, we would consider: (1) Whether the size of the attributed patient population is small; (2) whether the relative magnitude of expenditures assessed under the payment arrangement is particularly small; and (3) in the case of test of limited size and scope, whether the difference between actual expenditures and expected expenditures would not be statistically significant even when actual expenditures are 4 percent above expected expenditures. We note that we would grant such exceptions rarely, and we would expect APMs considered for such exceptions to demonstrate that a sufficient number of APM Entities are likely to incur losses in excess of the higher MLR. In other words, the potential for financial losses based on statistically significant expenditures in excess of the benchmark remains meaningful for participants.
Second, we proposed that the payment required by the payer could be smaller when actual expenditures exceed expected expenditures by enough to trigger a payment greater than or equal to the total risk amount required under the nominal amount standard. This exception ensures that the marginal risk requirement does not effectively require payers to incorporate total risk greater than the amount required by the total risk portion of the standard to become Other Payer Advanced APMs.
In evaluating both the total and marginal risk portions of the nominal amount standard, we would not include any payments the APM Entity or its participating eligible clinicians would make to the other payer if actual expenditures exactly matched expected expenditures. In other words, payments made to a payer outside the risk arrangement related to expenditures would not count toward the nominal amount standard. This requirement ensures that perfunctory or pre-determined payments do not supersede incentives for improving efficiency. For example, a payment arrangement that simply requires an APM Entity to make a payment equal to 5 percent of the payment arrangement benchmark at the end of the year, regardless of actual expenditure performance, would not satisfy the nominal amount standard.
Finally, we proposed that the amounts described in this section need not take a shared savings structure in which financial risk increases smoothly based on the amount by which an APM Entity's actual expenditures exceed expected expenditures. The risk arrangement must be tied to expenditures, but the amount of that risk would not have to be directly proportional to expenditures. For instance, an APM Entity could be required to pay the payer a flat amount or an amount tied to the number of attributed beneficiaries in the case of exceeding an expenditure benchmark, provided that these amounts are otherwise structured in a way that satisfies the nominal amount standard.
Except for risk arrangements described under the Medicaid Medical Home Model Standard, we proposed that for a payment arrangement to meet the nominal amount standard the specific level of marginal risk must be at least 30 percent of losses in excess of the expected expenditures and total potential risk must be at least four percent of the expected expenditures.
In establishing the proposed criteria for Other Payer Advanced APMs, we kept the approach to nominal risk as consistent as possible with the approach for the proposed Advanced APM criteria. The statute specifies that the Advanced APM Entity must bear more than nominal financial risk if actual aggregate expenditures exceed expected aggregate expenditures. We believe it is important, to the extent possible and consistent with the statute, to adopt consistent financial risk standards with the Advanced APM standard as described in section II.F.4.a of the proposed rule, so that eligible clinicians can base their decisions on participation in these Other Payer Advanced APMs on a consistent set of criteria. The Advanced APM nominal amount standard section of the proposed rule,
For Medicaid APMs we proposed the same standard as for Other Payer Advanced APMs. However, we recognize that Medicaid practitioners may be less able to bear substantial financial risk because they serve low-income populations and those with significant health disparities. Therefore, we solicited comment and supporting evidence on whether the proposal offered identifies the appropriate amounts of nominal risk for Medicaid APMs.
The following is a summary of the comments we received regarding our proposal to set a generally applicable Other Payer Advanced APM nominal amount standard.
An additional commenter requested that the nominal amount standard initially mirror the medical home approach so that it is assessed through APM Entity revenue or a choice between APM Entity revenue and Advanced APM benchmarks, and has low requirements with phased increases mirroring the approach taken with Medicaid Medical Home Models.
We put these protections in place for Other Payer Advanced APMs and not Advanced APMs because we have direct control over the design of Advanced APMs but not of payment arrangements of other payers We must act in the interest of the Medicare Trust Funds when designing Advanced APMs, but other payers do not have the same obligation and thus may be interested in assisting APM Entities to receive the APM Incentive Payment. Although states design and implement Medicaid APMs that are generally subject to federal approval processes such as state plan amendment approvals, we have no direct or indirect control over the payment arrangements of private payers. Including marginal risk as a component of the nominal amount standard prevents the consideration of payment arrangement designs that could contribute to the attainment of QP status through arrangements far less rigorous than those in Advanced APMs. There may be other ways of achieving the same program integrity goals and we seek comment on this policy. For instance, we are considering ways to issue guidance or design federal approval processes to promote Medicaid APMs focused on high value care to Medicaid beneficiaries that also align with our program integrity objectives.
One commenter recommended that CMS use risk corridors across programs to allow APMs to align their operations and financial approach, while reducing administrative overhead. One commenter suggested a 30 percent marginal risk threshold, with a 1-2 percent minimum loss rate, and recommended that CMS consider using the full-risk structure within the Next Generation ACO model as a framework when assessing nominal risk.
After considering the comments, we are finalizing the proposed policy with modifications. First, we are finalizing the marginal risk and MLR components as proposed. To meet the Other Payer Advanced APM nominal amount standard, a payment arrangement's level of marginal risk must be at least 30 percent of losses in excess of the expected expenditures, and the maximum allowable MLR must be 4 percent. We seek additional comments on this approach for Other Payer Advanced APMs and additional information on other approaches that ensure payment arrangements are not engineered to meet the financial risk criterion but avoid the likelihood of APM Entities experiencing losses based on their performance.
Second, we are finalizing that a payment arrangement must require APM Entities to bear financial risk for at least 3 percent of the expected expenditures for which an APM Entity is responsible under the payment arrangement. For episode payment models, expected expenditures means the target price for an episode. We also note that we intend to establish through future rulemaking a total risk standard based on the revenue of the APM Entity from the payer in a manner that would parallel the standard we are finalizing in the Advanced APM nominal amount standard under section II.F.4.b.(4) of this final rule with comment period. Therefore, we seek comment for future consideration on the amount and structure of the revenue-based nominal amount standard for QP Performance Periods in 2019 and later. Specifically, we seek comment on: (1) Setting the revenue-based standard for 2019 and later at up to 15 percent of revenue; or (2) setting the revenue-based standard at 10 percent so long as risk is at least equal to 1.5 percent of expected expenditures for which an APM Entity is responsible under an APM. We expect to apply the same percentage standards for Other Payer Advanced APMs as for Advanced APMs; however, we seek comment on how and why this standard could differ for Medicaid APMs relative to the generally applicable Other Payer Advanced APM standard.
Our intention in setting a revenue-based nominal amount standard is to tailor the level of risk an APM Entity must bear relative to the resources available to it. In instances where an APM Entity is one component of a larger health care provider organization, we believe that the revenue of the larger organization is a more accurate measure of the resources available to the APM Entity and should be the basis for setting the revenue-based nominal amount standard, even if only a portion of the organization is participating in the APM Entity.
However, we do not believe that applying the nominal amount standard at a level other than the APM Entity is operationally feasible at this point in time, and doing so in the other payer context may pose unique challenges relative to those we face under Medicare. Nevertheless, ideally, the nominal amount standard would take into consideration the resources available to an APM Entity using a measure such as revenue for the parent organization. We are evaluating the feasibility of implementing such a measure in lieu of APM Entity revenue for the third year of the program and later years. Under such an approach, we would anticipate basing the revenue-based nominal amount standard on the total revenues from a payer across the APM Entity, any parent organizations, any subsidiary organizations, and any subsidiaries of parent organizations for all eligible clinicians and groups who are participants of an APM Entity. We seek comment on this approach and how such an approach could be implemented while minimizing burden on participants.
For Medicaid Medical Home Models, we proposed that the minimum total annual amount that an APM Entity must potentially owe or forego to be considered an Other Payer Advanced APM must be at least:
• In 2019, 4 percent of the APM Entity's total revenue under the payer.
• In 2020 and later, 5 percent of the APM Entity's total revenue under the payer.
We believe that because few Medicaid Medical Home Model participants have experience with financial risk, and because they tend to be smaller in size, both in terms of the number of clinicians and revenue, than other APM Entities, we should not include a potentially excessive nominal amount for such entities in the first year of the program. We have also taken into account that the statute explicitly highlights Medical Home Models for special treatment under the Quality Payment Program. We generally have less information on Medicaid Medical Home Models and their performance to date compared to our information on Medical Home Models. Medicaid Medical Home Models are still developing, and we believe the introduction of a nominal amount standard that is not currently widely represented in the marketplace should be approached in a measured manner. We therefore believe that the unique characteristics of Medicaid Medical Home Models warrant the application of
We solicited comment on the proposed nominal amount standard. We also solicited comment on the potential inclusion of a marginal risk amount in the standard and the extent to which it would be applicable.
The following is a summary of the comments we received regarding our proposal to set a Medicaid Medical Home Model nominal amount standard.
After considering public comments, we are finalizing the Medicaid Medical Home Model nominal amount standard as proposed. In order to be an Other Payer Advanced APM, the minimum total annual amount that a Medicaid Medical Home Model must require an APM Entity to potentially owe or forego must be at least:
• In 2019, 4 percent of the APM Entity's total revenue under the payer.
• In 2020 and later, 5 percent of the APM Entity's total revenue under the payer.
We proposed that full capitation risk arrangements would meet the Other Payer Advanced APM financial risk criterion. We proposed that for purposes of this rulemaking, a capitation risk arrangement means a payment arrangement in which a per capita or otherwise predetermined payment is made to an APM Entity for services furnished to a population of beneficiaries, and no settlement is performed for the purpose of reconciling or sharing losses incurred or savings earned by the APM Entity. Our rationale for this policy is the same as the rationale on capitation for Advanced APMs described in section II.F.4.b.(3) of this final rule with comment period. As such, we reiterated that full capitation risk arrangements are not simply a cash flow mechanism.
We solicited comment on our proposal that capitation risk arrangements would meet the financial risk criterion for Other Payer Advanced APMs and on our proposed definition of a capitation risk arrangement. We also solicited comment on other types of arrangements that may be suitable for such treatment for purposes of this financial risk criterion.
The following is a summary of the comments we received regarding our proposal that full capitation risk arrangements will automatically meet the Other Payer Advanced APM financial risk criterion.
One commenter supported the proposal that that full capitation risk arrangements meet the financial risk criterion for APM Entities with full downside risk, but noted that some entities are in the middle of transforming their practices. The commenter stated that risk during transition could be mitigated through risk corridors and other methods that could be used while payers are obtaining and improving data necessary to improve the appropriateness of rates to health plans and clinicians.
After considering public comments, we are finalizing our proposal that full capitation risk arrangements will automatically meet the Other Payer Advanced APM financial risk criterion and our proposal to define capitation risk arrangement without changes.
In accordance with sections 1833(z)(2)(B)(iii)(II)(cc)(BB) and (C)(iii)(II)(cc)(BB) of the Act, we proposed that Medicaid Medical Home Models that meet criteria comparable to a Medical Home Model expanded under section 1115A(c) of the Act would meet the Other Payer Advanced APM financial risk criterion. We proposed that we would specify in subsequent rulemaking the criteria of any Medical Home Model that is expanded under section 1115A(c) of the Act that would be used for purposes of making this comparability assessment. We believe that the expanded Medical Home Model criteria can only be used for comparison when a Medical Home Model is, in fact, expanded as described in section II.F.4.b.(6) of the proposed rule, not merely by satisfying the expansion criteria under section 1115A(c) of the Act. If no such Medical Home Model has actually been expanded under section 1115A(c) of the Act, we would not have any criteria for comparison. In the absence of any expanded Medical Home Model to which we could draw comparisons, Medicaid Medical Home Models must meet the financial risk criterion through the other provisions (the financial risk and nominal amount
The following is a summary of the comments we received regarding our proposal to address criteria comparable to expanded Medicaid Medical Home Models in future rulemaking.
We are finalizing our proposal that Medicaid Medical Home Models that meet criteria comparable to a Medical Home Model expanded under section 1115A(c) of the Act would meet the Other Payer Advanced APM financial risk criterion. We will specify in future rulemaking the criteria for any Medical Home Model that is expanded under section 1115A(c) of the Act, and specify how they would be used for purposes of making this comparability assessment.
For the APM Incentive Payment, section 1833(z)(1)(A) of the Act states that the APM Incentive Payment is based on payments for Part B covered professional services, which do not include payments for services furnished to MA enrollees. For QP determination calculations, we believe it is important to note that Advanced APMs may involve MA plans and payers other than Medicare. Under the All-Payer Combination Option for QP determinations, eligible clinicians can meet the QP threshold based in part on payment amounts or patients counts associated with MA plans and other payers, provided that such arrangements meet the criteria to be considered Other Payer Advanced APMs. However, under sections 1833(z)(2)(A), (2)(B)(i), and (3)(B)(i) of the Act, payments under MA and other payer arrangements cannot be included in the QP determination calculations under the Medicare Option, which requires that we only consider payment amounts or patient counts for Medicare Part B covered professional services.
Regardless of which option—Medicare or All-Payer Combination—is used to determine that an eligible clinician is a QP for a year, the APM Incentive Payment calculation will only be based upon payments for Medicare Part B covered professional services, which does not include payments for services furnished to MA enrollees.
We recognize that MA contracts can include financial risk as well as quality performance standards, CEHRT, and other health IT requirements that support high-value care. We proposed to evaluate payment arrangements between eligible clinicians, APMs Entities, and MA plans according to the proposed Other Payer Advanced APM criteria. In the assessment of MA plans for the Other Payer Advanced APM criteria, it is important to note that the requirements refer to aspects of the payment arrangement between the MA plan and the participating APM Entity, and this includes the criterion for bearing more than a nominal amount of financial risk. We noted that we will not consider an arrangement in which the MA plan meets the CEHRT and quality measures criteria, but pays the APM Entity on a FFS basis, to be an Other Payer Advanced APM because there is no risk connected to actual cost of care exceeding projected cost of care. Because this arrangement would not be an Other Payer Advanced APM, it would not be considered for purposes of QP determinations. In addition, the financial relationship between CMS and the MA plan—even if the relationship is part of an APM—is not relevant to this assessment because there would not be a direct payment arrangement between CMS and the APM Entities or eligible clinicians.
The following is a summary of the comments we received regarding how MA plans will be treated in the Medicare Option and the All-Payer Combination Option.
A few commenters stated that if CMS included MA under the Medicare Option, several high-performing plans would meet the Advanced APM criteria. The commenters stated that CMS could use its section 1115A authority to designate MA plans as Advanced APMs.
Therefore, we understand the value of aligning measures across payers. Although measures of health plans are beyond the scope of this rule and do not necessarily measure the same performance as measures used under MIPS and APMs, which relate directly to health care provider performance, we
We may apply one or both of two different methods—using payment amounts or patient counts—to arrive at an eligible clinician's Threshold Score. We would compare the Threshold Score against the relevant QP Threshold or Partial QP Threshold to determine an eligible clinician's QP status for the year.
We proposed that we would calculate Threshold Scores for eligible clinicians in an Advanced APM Entity under both the payment amount and patient count methods for each QP Performance Period. We also proposed that we would assign QP status using the more advantageous of the Advanced APM Entity's two scores.
We believe that both the payment amount and patient count methods should be considered in order to produce Threshold Scores. As the two calculations differ there may be cases in which Threshold Scores vary enough that different QP determinations could result depending on which is used. In such an event, we do not believe that prioritizing the Threshold Score using one calculation over the other would yield an appropriate, non-arbitrary result. By using the greater of the Threshold Scores achieved, we hope to promote simplicity in QP determinations and to maximize the number of eligible clinicians that attain QP status each year. We solicited comment on the use of the payment and patient count methods for the All-Payer Combination Option.
The following is a summary of the comments we received regarding our proposal to calculate the Threshold Score for eligible clinicians participating in Other Payer Advanced APMs by either the payment amount or patient count method.
We are finalizing our proposal to calculate Threshold Scores for eligible clinicians in an APM Entity under both the payment amount and patient count methods for each QP Performance Period. We will make QP determinations using the more advantageous of the APM Entity's two scores.
Section 1833(z)(2)(B)(ii)(I) and (C)(ii)(I) of the Act specifies that the calculation under the All-Payer Combination Option is based on the sum of both payments for Medicare Part B covered professional services and, with certain exceptions, all other payments, regardless of payer. We proposed that we would include such “all other” payments in the numerator and the denominator, and we would exclude payments as specified in the statute. We also proposed to exclude patients associated with these excluded payments from the patient count method.
The statute excludes payments made:
• By the Secretary of Defense for the costs of Department of Defense health care programs;
• By the Secretary of Veterans Affairs for the costs of Department of Veterans Affairs health care programs; and
• Under Title XIX in a state in which no Medicaid Medical Home Model or APM is available under the state plan.
We proposed that title XIX payments or patients would be excluded in the numerator and denominator for the QP determination unless: (1) A state has at least one Medicaid Medical Home Model or Medicaid APM in operation that is determined to be an Other Payer Advanced APM; and (2) the relevant Advanced APM Entity is eligible to participate in at least one of such Other Payer Advanced APMs during the QP Performance Period, regardless of whether the APM Entity actually participates in such Other Payer Advanced APMs. This would apply to both the payment amount and patient count methods. We believe this Medicaid exclusion avoids penalizing eligible clinicians who do not have the possibility of participation in an Other Payer Advanced APM under Medicaid. We believe that failing to exclude such payments and/or patients would unduly disadvantage potential QPs by inflating denominators based on circumstances beyond their control. For example, if a state's Medicaid Medical Home Model is determined to be an Other Payer Advanced APM and is operated on a statewide basis, Medicaid payments would be included in the denominator for all eligible clinicians in that state assessed under the All-Payer Combination Option. However, if the state operates such an Other Payer Advanced APM at a sub-state level, and eligible clinicians who do not practice in the geographic area where the Medicaid Medical Home Model is available are not eligible to participate, Medicaid payments would not be included in such eligible clinicians' QP calculations. We plan to more fully develop the approach to identify Medicaid Medical Home Models and Medicaid APMs, as well as eligible clinicians participating in them, through subsequent rulemaking.
We solicited comment on our proposals to determine payment exclusions and on how we could account for eligible clinician participation in Medicaid APM or Medicaid Medical Home Models, such as pilots where participation may be intentionally limited by the state.
After considering the public comments, we are finalizing our proposal for determining exclusions of payments in the numerator and denominator for the QP determination without changes. The calculation under the All-Payer Combination Option is based on the sum of both payments for Medicare Part B covered professional services and, with certain exceptions, all other payments, regardless of payer. We will include such “all other” payments in the numerator and the denominator and exclude payments as specified in the statute. We will also exclude patients associated with these excluded payments from the patient count method, as proposed.
The payments excluded are those made:
• By the Secretary of Defense for the costs of Department of Defense health care programs;
• By the Secretary of Veterans Affairs for the costs of Department of Veterans Affairs health care programs; and
• Under Title XIX in a state in which no Medicaid Medical Home Model or APM is available under the state plan.
We proposed to calculate an All-Payer Combination Option Threshold Score for eligible clinicians in an Advanced APM Entity using the proposed payment amount method, which would then be compared to the relevant QP Payment Amount Threshold and Partial QP Payment Amount Threshold to make a QP determination.
We proposed to calculate the All-Payer Threshold Score for eligible clinicians in an Advanced APM Entity (or an eligible clinician that participates in multiple APMs, as this exception was discussed in the proposed rule) by dividing the numerator value described under section II.F.7.c.(3)(a)(ii) of this final rule with comment period by the denominator value described under section II.F.7.c.(3)(a)(iii) of this final rule with comment period. This calculation would result in a percent value Threshold Score that we would compare to the QP Payment Amount Threshold and the Partial QP Payment Amount Threshold to determine the QP status of the eligible clinicians for the payment year. The calculations occur in two steps because there is a Medicare QP Threshold and an All-Payer QP Threshold.
We proposed that the numerator would be the aggregate of all payments from all other payers, except those excluded under sections 1833(z)(2)(B)(ii)(I) and (C)(ii)(I) of the Act, to the Advanced APM Entity's eligible clinicians—or the eligible clinician in the event of an individual eligible clinician assessment—under the terms of all Other Payer Advanced APMs during the QP Performance Period. Medicare Part B covered professional services will be calculated under the All-Payer Combination Option in the same manner as it will be under the Medicare Option.
We proposed that the denominator would be the aggregate of all payments from all payers, except those excluded under sections 1833(z)(2)(B)(ii)(I) and (C)(ii)(I) of the Act, to the Advanced APM Entity's eligible clinicians—or the eligible clinician in the event of an
In this example, an Advanced APM Entity participates in a Medicare ACO initiative, a commercial ACO arrangement, and a Medicaid APM. Each of the APMs is determined to be an Advanced APM. In the QP Performance Period for payment year 2021 (proposed in the proposed rule to be 2019), the Advanced APM Entity receives the following payments:
In Table 38, the Advanced APM Entity meets the minimum Medicare threshold (30% > 25%) to be considered under the All-Payer Combination Option. However, it fell short of the QP Payment Amount Threshold (43% < 50%). In this case, the Advanced APM Entity would meet the Partial QP Payment Amount Threshold (43% > 40%).
Another Advanced APM Entity in the same year receives the following payments:
In Table 39, the Advanced APM Entity meets the minimum Medicare threshold (40% > 25%) to be considered under the All-Payer Combination Option. It also exceeds the QP Payment Amount Threshold (61% > 50%). In this case, the eligible clinicians in the Advanced APM Entity would become QPs.
We solicited comment on the payment amount method described in this proposal and any potential alternative approaches.
The following is a summary of the comments we received regarding our payment amount method proposal.
An additional commenter requested more details around how the data for the Threshold Score numerator and denominator under the All-Payer Combination Option would be collected and calculated. One commenter requested clarification as to whether 100 percent of a clinician's qualifying risk-based payments for Medicaid services from an Other Payer Advanced APM would be eligible to count towards the All Payer Combination Option.
We are finalizing our proposal to calculate the All-Payer Combination Option Threshold Score for eligible clinicians in an Advanced APM Entity (or an eligible clinician that participates in multiple APMs) by dividing the numerator by the denominator value, as described above. This calculation will result in a percent value Threshold Score that we would compare to the QP Payment Amount Threshold and the Partial QP Payment Amount Threshold to determine the QP status of the eligible clinicians for the payment year. The calculations occur in two steps because there is a Medicare QP Threshold and an All-Payer QP Threshold. We are finalizing our proposal that the numerator is the aggregate of all payments from all other payers, except those excluded under sections 1833(z)(2)(B)(ii)(I) and (C)(ii)(I) of the Act, to the Advanced APM Entity's eligible clinicians—or the eligible clinician in the event of an individual eligible clinician
We are finalizing our proposal that the denominator is the aggregate of all payments from all payers, except those excluded under sections 1833(z)(2)(B)(ii)(I) and (C)(ii)(I) of the Act, to the Advanced APM Entity's eligible clinicians—or the eligible clinician in the event of an individual eligible clinician assessment—during the QP Performance Period.
We proposed to calculate a Threshold Score for the eligible clinician group in an Advanced APM Entity—or eligible clinician in the exception situations under sections II.F.5 and II.F.6 of the proposed rule—using the patient count method, which would then be compared against the relevant QP Patient Count Threshold and Partial QP Patient Count Threshold to determine the QP status of an eligible clinician for the year based on the higher of the two values.
We proposed that the Threshold Score calculation for the patient count method would include patients for whom the eligible clinicians in an Advanced APM Entity furnish services and receive payment under the terms of an Other Payer Advanced APM, with certain exceptions as outlined in the previous section. This calculation would result in a percent value Threshold Score that CMS would compare to the QP Patient Count Threshold and the Partial QP Patient Count Threshold to determine the eligible clinicians' QP status for the payment year. The calculations occur in two steps as there is a Medicare Threshold requirement and an All-Payer Threshold requirement.
First, we proposed that, like the Medicare Option, the patient count method under the All-Payer Combination Option would only count unique patients, with multiple eligible clinicians able to count the same patient. Similarly, we proposed to count a single patient, where appropriate, in the numerator and denominator for multiple different Advanced APM Entities when counting the number of beneficiaries under this method section II.F.6 of the proposed rule. We also proposed that we would not count any patient more than once for any single Advanced APM Entity. In other words, for each Advanced APM Entity, we would count each unique patient one time in the numerator, and one time in the denominator.
We believe that counting patients this way maintains integrity by preventing double counting of patients within an Advanced APM Entity while recognizing the reality that patients often have relationships with eligible clinicians in different organizations. We expect to avoid distorting patient counts for such overlap situations, especially in Advanced APM Entity-dense markets.
We solicited comment on our proposal for counting unique patients for the patient count method.
We proposed that the numerator would be the number of unique patients to whom eligible clinicians in the Advanced APM Entity furnish services that are included in the measures of aggregate expenditures used under the terms of all of their Other Payer Advanced APMs during the QP Performance Period, plus the patient count numerator for Advanced APMs. A patient would count in the non-Medicare portion of this numerator only if, as stated in the proposed rule, the eligible clinician furnishes services to the patient and receives payment(s) for furnishing those services under the terms of an Other Payer Advanced APM.
We proposed that the denominator would be the number of unique patients to whom eligible clinicians in the Advanced APM Entity furnish services under all non-excluded payers during the QP Performance Period.
In the QP Performance Period for payment year 2021the Advanced APM Entity experienced the following patient counts:
In Table 40, the Advanced APM Entity meets the minimum Medicare threshold (30% > 20%) to be considered under the All-Payer Combination Option. However, it fell short of the QP Patient Count Threshold (30% < 35%). In this case, the Advanced APM Entity would meet the Partial QP Patient Count Threshold (30% > 25%).
Another Advanced APM Entity in the same year experienced the following patient counts:
In Table 41, the Advanced APM Entity meets the minimum Medicare threshold (40% > 20%) to be considered under the All-Payer Combination Option. It also exceeds the minimum QP Patient Count Threshold (61% > 35%). In this case, the eligible clinicians in the Advanced APM Entity would become QPs.
We solicited comment on the patient count method described above and any potential alternative approaches.
We received no comments in response to our proposed patient count method. Section II.F.6.(c) of this final rule with comment has a detailed discussion of comments on this policy as it pertains to the Medicare Option.
We are finalizing our proposal to calculate the All-Payer Combination Option Threshold Score for eligible clinicians in an Advanced APM Entity (or an eligible clinician that participates in multiple APMs) by dividing the numerator by the denominator value, as described above. This calculation will result in a percent value Threshold Score that we would compare to the QP Patient Count Threshold and the Partial QP Patient Count Threshold to determine the QP status of the eligible clinicians for the payment year. The calculations occur in two steps because there is a Medicare QP threshold and an All-Payer QP threshold. We are finalizing our proposal that the numerator is the number of unique patients to whom eligible clinicians in the Advanced APM Entity furnish services that are included in the measures of aggregate expenditures used under the terms of all of their Other Payer Advanced APMs during the QP Performance Period, plus the patient count numerator for Advanced APMs.
We are finalizing our proposal that the denominator is the number of unique patients to whom eligible clinicians in the Advanced APM Entity furnish services under all non-excluded payers during the QP Performance Period.
Under sections 1833(z)(2)(B)(ii)(III) and (C)(ii)(III) of the Act, an eligible clinician can only become a QP using the All-Payer Combination Option by providing the Secretary such information as is necessary for the Secretary to determine whether a payment arrangement is an Other Payer Advanced APM and to determine the eligible clinician's Threshold Score.
We have the necessary data to make QP determinations and an APM Incentive Payments for Advanced APMs because they are administered within the Medicare program. Because Other Payer Advanced APMs are administered outside of the Medicare program, CMS needs to collect analogous data from specific sources who have that data to make QP determinations and APM Incentive Payments to those participating in Other Payer Advanced APMs. In order for CMS to perform QP determinations using the All-Payer Combination Option, submissions must include specific payment and patient numbers for each payer from whom the eligible clinician has received payments during the QP Performance Period.
We proposed that APM Entities or individual eligible clinicians must submit by a date and in a manner determined by us: (1) Payment arrangement information necessary to assess whether each payment arrangement is an Other Payer Advanced APM, including information on financial risk arrangements, use of certified EHR technology, and payment based on quality measures; and (2) for each payment arrangement, the amounts of revenues for services furnished through the arrangement, the total revenues from the payer, the numbers of patients furnished any service through the arrangement (that is, patients for whom the eligible clinician is at risk if actual expenditures exceed expected expenditures), and (3) the total number of patients furnished any service through the payer.
If we do not receive sufficient information to complete our evaluation of all other payer arrangements to perform the QP threshold calculation, we would not evaluate the eligible clinicians under the All-Payer Combination Option. If sufficient information is submitted, we would then assess the characteristics of the other payer arrangement to determine if it is an Other Payer Advanced APM and would notify the APM Entities and/or eligible clinicians of the Other Payer Advanced APM determinations based on their submissions. Because we proposed that an Other Payer Advanced APM is required to have an outcome measure, we propose that if an Other Payer Advanced APM has no outcome measure, the Advanced APM Entity must attest that there is no applicable outcome measure on the MIPS list. We intend to establish specific requirements regarding the timing and manner of submission of such information through future rulemaking.
We proposed that each payer attest to the accuracy of all submitted information including the reported payment and patient data. We proposed that if a payer does not attest to the accuracy of the reported payment and patient data, these data would not be assessed under the All-Payer Combination Option. However, we recognize that such a requirement leaves eligible clinicians dependent on a payer over which they may have limited control. We therefore solicited comment on alternatives to requiring payer attestation, such as addressing the scope and intensity of audits to verify the submitted data. For APM Entities and eligible clinicians participating in Medicaid, we would initiate a review and determine in advance of the QP Performance Period the existence of Medicaid Medical Home Models and Medicaid APMs based on information obtained from state Medicaid agencies and other authorities, such as professional organizations or research entities.
We solicited comment from stakeholders on the specific types of payment arrangement information that would be necessary to assess whether payment arrangement is an Other Payer Advanced APM, and the format in which we could reasonably expect to receive this information. We solicited comment on the level of detail which we should require, and whether certain pieces of information would be most easily submitted directly from individual eligible clinicians or from an APM Entity. We also solicited comment on the timing of when we could expect to receive this information from individual eligible clinicians and APM
We solicited comment on the possibility of receiving information on Other Payer Advanced APMs and their participants directly from other payers in order to minimize reporting burden for APM Entities and eligible clinicians. We solicited comment on the extent to which collecting voluntary submissions of data from other payers could reduce burden and increase program integrity through more accurate determinations of QP status based on payment or patient threshold calculations for Other Payer Advanced APMs. Likewise, we solicited comment on the extent to which such data collection is operationally feasible or could infringe upon other payers' interests in maintaining the confidentiality of their business practices.
In addition, we proposed to make early Other Payer Advanced APM determinations on other payer arrangements if sufficient information is submitted at least 60 days before the beginning of a QP Performance Period. This would allow us to offer eligible clinicians advance notice of their prospects of achieving QP status in the event they are assessed under the All-Payer Combination Option. This early determination would be considered final for the QP Performance Period based on the payment arrangement information submitted. If new information is submitted based on a change in the payment arrangement during the QP Performance Period, the initial determination could be subject to review and revision. We also proposed that, to the extent permitted by federal law, we would maintain confidentiality of certain information that the APM Entities and/or eligible clinicians submit regarding Other Payer Advanced APM status to avoid dissemination of potentially sensitive contractual information or trade secrets. We proposed that, unlike our proposal for Advanced APM determinations, the Other Payer Advanced APM determinations would be made available directly to participating APM Entities and eligible clinicians rather than through public notice, and we would explain how and within what timeframes such notifications will occur in subregulatory guidance. We may consider publicly releasing information on Other Payer Advanced APMs on the CMS Web site with general and/or aggregate information on the payers involved and the scopes of such agreements.
We solicited comment on the proposed timing and method of feedback to APM Entities and eligible clinicians regarding the status of Other Payer Advanced APMs for which they have submitted information and on the proposed early determination process and the ability of APM Entities and eligible clinicians to submit sufficient information prior to the beginning of a QP Performance Period. We also solicited comment on the types of information that contain potentially sensitive information.
The information submitted to determine whether an eligible clinician is a QP under the All-Payer Combination Option may be subject to audit, and eligible clinicians and APM Entities will be required to maintain copies of any supporting documentation. If an audit reveals a material discrepancy in the information submitted to us, and such discrepancy affected the eligible clinician's QP status, the APM Incentive Payment may be recouped. Providing false information may reflect a false claim subject to investigation and prosecution. We may provide further details on the audit and recoupment process under the All-Payer Combination Option in future rulemaking.
The following is a summary of the comments we received regarding our proposal to require APM Entities or eligible clinicians to submit information regarding their payment arrangements in order to be assessed under the All-Payer Combination Option.
Several commenters expressed concern or opposition to CMS requiring APM Entities and eligible clinicians to submit information for CMS to assess whether other payer arrangements meet the Other Payer Advanced APM criteria. Some of these commenters stated that payers should be required to submit the information because clinicians may not have the necessary information readily available. One of these commenters stated that, in order to ensure that plans and clinicians can continue to focus on delivering high-quality care, CMS should minimize the reporting required under the All-Payer Combination Option. Another commenter expressed concern that eligible clinicians could be reluctant to share their non-Medicare payment information with CMS. One commenter opposed CMS requiring eligible clinicians to submit the entirety of a contract with another payer, particularly sections including negotiated fee schedule or payment rates.
One commenter recommended that CMS should consider the same approach for Other Payer Advanced APMs that is used for Medicare Advantage plans. However, the commenter suggested that if CMS believes a different standard should apply to MA plans because of their contractual relationship with CMS, then CMS should apply the reasonableness standard that is enforced through the Medicare Advantage program in which a health plan would acknowledge, to the best of its knowledge, information, and belief, that the reported payment and patient counts were accurate. The commenter recommended that CMS apply this standard in a way that minimizes the reporting burden on MA plans. Another commenter encouraged CMS to consider establishing a data submission process that would allow MA plans to submit data on their arrangements in lieu of attestation. One commenter requested more detailed requirements for MA contracts and an explanation for how ACOs can attest to participating in such contracts.
Another commenter recommended CMS to consider expanding the third-party data partners to include state all-payer claims databases (APCDs) as a data submitter for those payment arrangement electing to utilize the state aggregator for reporting. This option would also have the potential to enhance the analytic opportunities for the APM Entity to work with the APCD to implement analytic tools and data products that benefit the patient population and the APM Entity beyond Medicare reporting requirements.
After considering the public comments, we are finalizing our proposed information submission requirements with no changes, but seek further comments on the process for submitting information. APM Entities or individual eligible clinicians must submit by a date and in a manner determined by CMS: (1) payment arrangement information necessary to assess whether each payment arrangement is an Other Payer Advanced APM, including information on financial risk arrangements, use of certified EHR technology, and payment tied to quality measures; and (2) for each payment arrangement, the amounts of payments for services furnished through the arrangement, the total payments from the payer, the numbers of patients furnished any service through the arrangement (that is, patients for whom the eligible clinician is at risk if actual expenditures exceed expected expenditures), and (3) the total numbers of patients furnished any service through the payer.
We are also finalizing our proposal that each payer attest to the accuracy of all submitted information including the reported payment and patient data. We proposed that if a payer does not attest to the accuracy of the reported payment and patient data, these data would not be assessed under the All-Payer Combination Option. We note that while we cannot require other payers to submit information, we could only be confident in the accuracy of information eligible clinicians submitted to us—and use such information in the All-Payer Combination Option—if other payers attest to the accuracy of that information.
The APM Incentive Payment is specified under section 1833(z)(1) of the Act.
This section describes our proposal for calculating the amount of the APM Incentive Payment and accounts for the specific scenarios outlined under sections 1833(z)(1)(A)(i) and 1833(z)(1)(A)(ii) of the Act. This section also describes the process by which we proposed to disburse these APM Incentive Payments to QPs.
In accordance with section 1833(z)(1)(A) of the Act, we would make an APM Incentive Payment for a year to eligible clinicians that achieve QP status for the year during years 2019 through 2024. In accordance with the statute, we proposed that this APM Incentive Payment must be equal to 5 percent of the estimated aggregate amounts paid for Medicare Part B covered professional services furnished by the eligible clinician from the preceding year across all billing TINs associated with the QP's NPI.
The following is a summary of the comments we received in response to our proposals regarding the amount of the APM Incentive Payment.
After considering public comments, we are finalizing our proposals regarding the calculation of the amount of the APM Incentive Payment as required by section 1833(z)(1)(A) of the Act. Specifically, we finalize our proposals that APM Incentive Payments will be made to eligible clinicians who are determined to be QPs during years 2019 through 2024. In accordance with the statute, we are finalizing our proposal that this APM Incentive Payment must be equal to 5 percent of the estimated aggregate payment amounts for Medicare Part B covered professional services furnished by the QP during the preceding year across all billing TINs associated with the QP's NPI.
The incentive payment base period is the range of dates that would be used to calculate the estimated aggregate payment amounts for the year preceding the QP payment year that would serve as the basis for the incentive payment. Section 1833(z)(1)(A) of the Act states that in calculating the amount that is equal to 5 percent of the estimated aggregate payment amounts for Medicare Part B covered professional services under this part for the preceding year, the payment amount for the preceding year may be an estimation for the full preceding year based on a period of such preceding year that is less than the full year. We believe this provision provides flexibility in determining the incentive payment base period. We proposed to use the full calendar year prior to the payment year as the incentive payment base period from which to calculate the estimated aggregated payment amounts.
Using a complete calendar year of claims would allow for the most accurate representation of the covered professional services delivered by each eligible clinician, which we believe outweighs a modest potential delay in making the APM Incentive Payment. We solicited comment on our proposal to use the entire preceding calendar year as the incentive payment base period.
The following is a summary of the comments we received in response to our proposal pertaining to the APM incentive payment base period.
After considering public comments, we are finalizing our proposal that the incentive payment base period is the full calendar year prior to the payment year.
Section 1833(z)(1)(A) of the Act directs us to make the APM Incentive Payment in a lump sum on an annual basis “as soon as practicable.” We believe that, in implementing this provision, it is important to balance the desire for accuracy in the data used to calculate the APM Incentive Payment with the desire to expedite the payments so that the APM Incentive Payments are made in an appropriate and timely manner.
We proposed to calculate the APM Incentive Payment based on data available 3 months after the end of the incentive payment base period in order to allow time for claims to be processed. For example, for the 2019 payment year, we would capture claims submitted with dates of service from January 1, 2018 through December 31, 2018 and processing dates of January 1, 2018 through March 31, 2019. We believe that 3 months of claims run-out is sufficient to conduct the APM Incentive Payment calculations in an accurate and timely manner. This methodology is consistent with the claims run-out timeframes used for reconciliation payments in several current APMs, such as the Shared Savings Program, the Pioneer and Next Generation ACO Models, and the CEC model. We solicited comment on the potential use of a completion factor. We note that several current APMs apply the 3-month claims run-out in conjunction with a completion factor. However, where a completion factor may be appropriate for payments based on claims submitted by groups of providers and suppliers that may be billing under multiple TINs, we believe that with payments based on individual eligible clinician claims, categorical variability in claims completion across types of eligible clinicians would cause inequitable results.
In summary, for the incentive payment base period we proposed to use a complete calendar year of claims with 3 months of claims run-out from the end of the calendar year. We believe our proposed approach balances our goals of providing incentive payments in a reasonable timeframe while being able to account for the vast majority (on average, 99.3 percent of claims for) covered professional services. Given these parameters, we estimated that APM Incentive Payments could be made approximately 6 months after the end of the incentive payment base period, or roughly mid-way through the payment year. However, we proposed that the APM Incentive Payment would be made no later than 1 year from end of the incentive payment base period. We did not propose to set a specific deadline mid-way during the payment year because we believe doing so could pose operational risks in the event that 6 months is impracticable in a given year for reasons that CMS cannot predict. We solicited comment on our proposed timing for when we will make the APM Incentive Payment during a payment year.
The following is a summary of the comments we received regarding our proposals for using 3 months of claims run-out when calculating the APM Incentive Payment and for the timing of making the APM Incentive Payment.
After considering public comments, we are finalizing our proposal to use 3 months of claims run-out when calculating the amount of APM Incentive Payment, and we are finalizing our proposal to make the APM Incentive Payment no later than 1 year from end of the incentive payment base period.
Part B covered professional services under the Medicare PFS are currently subject to several statutory provisions that are geared towards improving quality and efficiency in service delivery. Eligible clinicians are subject to payment adjustments under the Medicare EHR Incentive Program for Eligible Professionals (MU), the PQRS, and the VM. Beginning in 2019, the MIPS adjustment, as described in section II.E.5. of the final rule, will replace payment adjustments under the MU, PQRS, and VM for all MIPS eligible clinicians. These special payment adjustments directly adjust the payment amount that eligible clinicians receive under the PFS. In contrast, we consider the APM Incentive Payment to be separate from, and, as indicated under section 1833(z)(1)(A) of the Act, in addition to the amount of payments made for covered professional services under the Medicare PFS.
We proposed to exclude the MIPS, VM, MU and PQRS payment adjustments when calculating the estimated aggregate payment amount for covered professional services upon which to base the APM Incentive Payment amount. For example, a QP who receives an upward fee adjustment during 2018 in VM would not see that adjustment reflected in the estimated aggregate payment amount for covered professional services used to calculate his or her APM Incentive Payment in
We believed this proposed policy is most consistent with the specification in section 1833(z)(1)(A) of the Act that the APM Incentive Payment is based on the estimated aggregate payment amounts for “such” covered professional services for the preceding year, which refers to the Part B covered professional services furnished by the particular eligible clinician.
While we considered the alternative of including these performance-related payment adjustments in calculating the APM Incentive Payment, we were concerned that such a policy would create incentives that are not aligned with the intent of the APM Incentive Payment. As previously stated in our policy principles, we believe that the APM Incentive Payment is best viewed as a complementary reward for eligible clinicians that have a substantial degree of participation in the most advanced APMs, not an evaluation of their performance within the APM or in another statutorily required performance-based payment adjustment.
We also proposed in section II.F.6.b.(1) of the proposed rule to account for payment adjustments in the QP determination process in the same manner as when calculating the amount of the APM Incentive Payment. If we were to include statutory payment adjustments when determining QP status, there could be situations where an eligible clinician could become a QP because of a positive payment adjustment amount, or conversely, there could be situations where an eligible clinician would not meet the QP threshold because of a negative payment adjustment. We believe that our proposal to not include payment adjustments when determining QP status for a year, or when calculating the amount of the APM Incentive Payment, allows us to assess all eligible clinicians on the same merits throughout the entire QP determination and when calculating the APM Incentive Payment. We do not believe the intent of the statute was to enhance or negate an eligible clinician's opportunity to become a QP in a given performance year, or to enhance or negate the amount of APM Incentive Payment a QP receives, based on factors that are extraneous to APM participation.
We solicited comment on this proposed approach to coordinating the various PFS payment adjustments when calculating the amount of the APM Incentive Payment.
The following is a summary of the comments we received regarding our proposals for how to treat PFS payment adjustments when calculating the amount of the APM Incentive Payment.
After considering public comments, we are finalizing our proposal to exclude the MIPS, VM, MU and PQRS payment adjustments when calculating the estimated aggregate payment amount for covered professional services upon which to base the APM Incentive Payment amount.
We recognize that many APMs use incentives and financial arrangements that differ from usual fee schedule payments. Section 1833(z)(1)(A)(i) of the Act requires us to establish policies for payments that are made to an Advanced APM Entity rather than directly to the QP. Section 1833(z)(1)(A)(ii) of the Act requires us to establish policies for when payment is made on a basis other than FFS. For the purposes of this rule, we place such payments into three categories: Financial risk payments, supplemental service payments, and cash flow mechanisms. We also recognize that payment methods and financial arrangements may evolve over time and those would need to be addressed in future rulemaking. We solicited comment on the proposals for accounting for risk-based payments, supplemental service payments, and cash flow mechanisms when calculating the amount of APM Incentive Payment.
Financial risk payments are non-claims-based payments based on performance in an APM when an APM Entity assumes responsibility for the cost of a beneficiary's care, whether it be for an entire performance year, or for a shorter duration of time, such as over the course of a defined episode of care. We note that in the context of categorizing these types of payments as “financial risk payments,” we refer to payments that may be based on the cost of a beneficiary's care and do not necessarily limit these payments to financial arrangements that would require an APM Entity to accept downside risk. For instance, we would consider the shared savings payments made to ACOs in all tracks of the Shared Savings Program to be financial risk payments. We would also consider net payment reconciliation amounts from us to an Awardee (or vice versa) under the BPCI Initiative, and reconciliation payments from us to a participant hospital or repayment amounts from a participant hospital to us under the CJR model to be examples of financial risk payments.
We proposed to exclude financial risk payments when calculating the estimated aggregate payment amount for covered professional services upon which to base the APM Incentive Payment amount. Financial risk payments are not for specific Medicare Part B covered professional services; rather they are for performance in an APM. Therefore, we believe their inclusion in the estimated aggregate payment amount would be inconsistent with the statutory language and our stated policy principles. In addition, the difficulty of disaggregating payments to individual QPs and the lagged timing of some financial risk payments creates significant policy and operational barriers that we do not believe are in line with our objective of making APM Incentive Payments in a timely manner.
The following is a summary of the comments we received regarding our proposal to exclude financial risk payments when calculating the amount of the APM Incentive Payment.
Additionally, we note that many financial risk payments are calculated based on the performance of the APM Entity as a whole, not on the performance of individual eligible clinicians that participate in the APM Entity. We do not currently have a way in which we are able to attribute portions of a financial risk payment to an APM Entity to individual eligible clinicians.
After considering public comments, we are finalizing our proposal to exclude financial risk payments when calculating the amount of APM Incentive Payment.
Supplemental service payments are Medicare Part B payments for longitudinal management of a beneficiary's health or for services that are within the scope of medical and other health services under Medicare Part B that are not separately reimbursed through the PFS. Often these are per-beneficiary per-month (PBPM) payments that are made for care management services or separately billable services that share the goal of improving quality of care overall, enabling investments in care improvement, and reducing Medicare expenditures for services that could be avoided through care coordination. For example, OCM makes a per beneficiary Monthly Enhanced Oncology Services (MEOS) payment to practices for care management and coordination during episodes of care initiated by chemotherapy treatment.
We proposed to determine whether certain supplemental service payments are in lieu of covered services that are reimbursed under the PFS. In cases where payments are for covered services that are in lieu of services reimbursed under the PFS, those payments would be considered covered professional services and would be included in the APM Incentive Payment amounts. We proposed to include a supplemental service payment in calculation of the APM Incentive Payment amount if it meets all of the following 4 criteria:
(1) Payment is for services that constitute physicians' services authorized under section 1832(a) of the Act and defined under section 1861(s) of the Act;
(2) Payment is made for only Part B services under the first criterion above, that is, payment is not for a mix of Part A and Part B services;
(3) Payment is directly attributable to services furnished to an individual beneficiary; and
(4) Payment is directly attributable to an eligible clinician.
We further proposed to establish a process by which we notify the public of the supplemental service payments in all APMs and identify the supplemental service payments that meet our proposed criteria and would be included in the APM Incentive Payment calculations. Similar to our proposal to announce Advanced APM determinations, we proposed to post an initial list of supplemental service payments that would be included in our APM Incentive Payment calculations on the CMS Web site. As new APMs are announced, we would include the determination of whether supplemental service payment related to that APM would be included in our APM Incentive Payment calculations, if applicable, in conjunction with the first public notice of the APM. We proposed to update the list of supplemental service payments that would be included in our APM Incentive Payment calculations on an ad hoc basis, but no less frequently than on an annual basis.
We solicited comment on this proposed approach to include certain supplemental service payments when calculating the basis for the amount of the APM Incentive Payment. Specifically, we solicited comment on our proposed criteria to include supplemental service payments in the basis for the APM Incentive Payment amounts, and our proposed method for announcing which supplemental service payments would be included in the basis for the APM Incentive Payment amounts.
The following is a summary of the comments we received regarding our proposals for how to consider certain supplemental service payments when calculating the amount of the APM Incentive Payment.
Other commenters stated that CMS should withdraw its proposal to make specific determinations on each supplemental services payment based on the proposed criteria. These commenters were concerned this proposal adds unnecessary complexity and uncertainty to the calculations and could provide a disincentive for physicians who want to transition away from a FFS approach.
After considering public comments, we are finalizing our proposal to determine whether certain supplemental service payments are in lieu of covered professional services that are paid under the PFS on the basis of the four proposed criteria:
(1) Payment is for services that constitute physicians' services authorized under section 1832(a) of the Act and defined under section 1861(s) of the Act;
(2) Payment is made for only Part B services under the first criterion above, that is, payment is not for a mix of Part A and Part B services;
(3) Payment is directly attributable to services furnished to an individual beneficiary; and
(4) Payment is directly attributable to an eligible clinician.
We are also finalizing our proposal to establish a process by which we notify the public of the supplemental service payments in all APMs and identify the supplemental service payments that will be included in the APM Incentive Payment calculations. This process includes posting an initial list of supplemental service payments that would be included in our APM Incentive Payment calculations on the CMS Web site. We are finalizing our proposal that we will update this list no less frequently than annually and that we will include determinations and updates to this list as new APMs with supplemental service payments are announced.
Cash flow mechanisms involve changes in the method of payments for services furnished by providers and suppliers participating in an APM Entity. In themselves, cash flow mechanisms do not change the overall amount of payments. Rather, they change cash flow by providing a different method of payment for services. An example of a cash flow mechanism is the population-based payment (PBP) available in the Pioneer ACO Model and the Next Generation ACO Model. A PBP is a monthly lump sum payment in exchange for a percentage reduction in Medicare FFS payments to certain ACO providers and suppliers.
For expenditures affected by cash flow mechanisms, we proposed to calculate the estimated aggregate payment amount using the payment amounts that would have been incurred for Part B covered professional services if the cash flow mechanism had not been in place. For example, for QPs in an ACO receiving a PBP that have agreed to a 50 percent reduction in FFS payments, we would use the amount that would have been paid for Part B covered professional services in the absence of the 50 percent reduction. Cash flow mechanisms represent a potential reallocation of dollars between eligible clinicians and APM Entities for specific purposes related to care improvement. We do not believe that the presence of cash flow mechanisms should impact the APM Incentive Payment amount, and we do not intend for the APM Incentive Payment to influence the use or attractiveness of cash flow mechanisms in current and future APMs.
The following is a summary of the comments we received regarding our proposal for how to account for payments affected by any cash flow mechanism when calculating the amount of the APM Incentive Payment.
After considering public comments, we are finalizing our proposal to calculate the estimated aggregate payment amount using the payment amount that would have been made for Part B covered professional services if the cash flow mechanism had not been in place.
Section 1833(z)(1)(A)(i) of the Act requires us to establish policies for payments that are made to an Advanced APM Entity rather than directly to a QP. We recognize that new payment methods and financial arrangements may be developed as part of APMs that meet this criterion. For instance, in the recently announced CPC+ Model, the supplemental service payments (that is, the CMFs) would meet all of our proposed criteria to be included in the APM Incentive Payment calculations. The CMFs are for Medicare Part B covered professional services and only Medicare Part B covered professional services. The CMF payment amounts would be risk-adjusted based on each individual beneficiary's HCC risk scores; therefore, these payments will be attributable to individual beneficiaries. Additionally, the attribution method in the CPC+ Model uses a combination of the TIN/Individual NPI/Practice Address when attributing an individual beneficiary to a CPC+ Practice site. However, the CMF payments for attributed beneficiaries are aggregate payments made to each CPC+ Practice Site. We recognize that throughout the course of a QP Performance Period more than one NPI may furnish covered professional services to an attributed beneficiary. If that occurs, more than one NPI could potentially receive the corresponding CMF for that eligible beneficiary. We do not believe it would be appropriate to count the same CMF for more than one NPI. Therefore, assuming that the CPC+ Model is determined to be an Advanced APM and the APM Entity group achieves the QP threshold for a year, we could split the CMF amounts equally between the multiple NPIs, or we could develop a method based on the plurality of visits with that beneficiary to “assign” the NPI to which the CMFs would be credited for purposes of the APM Incentive Payment calculation.
We solicited comment on how to allocate payments made to an APM Entity rather than an eligible clinician.
The following is a summary of the comments we received regarding our proposal.
After considering public comments, we are finalizing our proposal that when payments are paid to an APM Entity instead of to an individual eligible clinician, and those payments are not attributable to an individual eligible clinician, we will divide the amount of such payments s equally across all eligible clinicians who are on the Participation List for that APM Entity, and each eligible clinician who is a QP will be considered to have been paid that portion of the payments for
Section 1833(z)(1)(D) of the Act specifies that we shall not include certain existing Medicare incentive payments in the calculation of the APM Incentive Payment. This includes payments made under section 1833 of the Act (sections (m), (x), and (y)).
Section 1833(m) of the Act describes the HPSA Physician Bonus Program. The HPSA Physician Bonus Program provides bonus payments to physicians for physicians' services furnished in geographic areas that are designated as of December 31 of the prior year by HRSA as HPSAs under section 332(a)(1)(A) of the PHS Act. The HPSA bonus payment is 10 percent of the Medicare Part B payment amount for the service; and this bonus is paid as a quarterly lump sum payment.
Section 1833(x) of the Act describes the Primary Care Incentive Payment (PCIP) program. The PCIP payment amount was 10 percent of the payment amount for Medicare Part B primary care services furnished by primary care practitioners for whom primary care services accounted for at least 60 percent of their allowed FFS charges in a prior qualification period. For purposes of the PCIP program, primary care practitioners were defined as physicians with certain Medicare specialty codes and as certain types of non-physician practitioners. The PCIP payment was made on a quarterly basis. This bonus payment expired under the statute on December 31, 2015.
Section 1833(y) of the Act describes the HPSA Surgical Incentive Payment (HSIP). For major surgical procedures furnished by physicians with a primary specialty designation of “general surgeon” in HPSAs (under section 332(a)(1)(A) of the PHS Act), physicians received an additional 10 percent bonus payment in addition to the amount of payment that would have otherwise been made. This additional payment was combined with any other HPSA payment outlined in section 1833(m) of the Act and was paid on a quarterly basis. This bonus payment expired under the statute on December 31, 2015.
Section 1833(z)(1)(D) of the Act also directs us not to include APM Incentive Payments when calculating payments made under section 1833 (sections (m), (x), and (y)) of the Act. We consider the APM Incentive Payment to be separate from the incentive payments as previously discussed in the proposed rule, and we have established procedures to ensure that the APM Incentive Payment would not be included when calculating the amount of incentive payments made under section 1833(m), (x), and (y) of the Act.
We received no comments in response to our proposal this section.
As directed by the statute, we are finalizing our proposal not to include incentive payments made under section 1833(m), (x), and (y) of the Act when calculating the amount of the APM Incentive Payment, and not to include APM Incentive Payments when calculating payments made under section 1833(m), (x), and (y) of the Act.
Section 1833(z)(1)(C) of the Act states that the amount of the APM Incentive Payment shall not be taken into account for purposes of determining actual expenditures under an APM and for purposes of determining or rebasing any benchmarks used under the APM. As a lump sum payment, the APM Incentive Payments will be made outside of the Medicare claims processing system. Current APMs, such as the Medicare ACO initiatives and the CJR model, have established procedures for ensuring that lump sum payments from other APMs are excluded when they do their APM reconciliations and rebasing calculations. We anticipate that each APM will have in place a procedure to avoid counting APM Incentive Payments toward determining actual expenditures or rebasing any benchmarks under the APM.
The following is a summary of comments we received in response to our proposals for how to treat the APM Incentive Payment in APM-related calculations.
Another commenter requested further confirmation from CMS that the MIPS payment adjustments are not included in Medicare ACO expenditures for benchmark calculations. The commenter stated that if this were not the case, it would create a disincentive for participation in an ACO and nullify the incentive of an upward payment adjustment.
Eligible clinicians who furnish services at CAHs that have elected to be paid for outpatient services under section 1834(g)(2)(B) of the Act (Method II) will be eligible to become QPs and receive the APM Incentive Payment if they are part of an Advanced APM Entity. As stated in section II.F.6.d.(1) of this final rule with comment, professional services furnished at a Method II CAH are considered “covered professional services” because they are furnished by an eligible clinician and payments are based on the Medicare PFS. Therefore, we proposed that the APM Incentive Payment would be based on the amounts paid for those services attributed to the eligible clinician in the same manner as all other covered professional services.
For an eligible clinician who becomes a QP based on covered professional services furnished at a Method II CAH, we proposed that the APM Incentive Payment would be made to the CAH TIN that is affiliated with the Advanced APM Entity. This proposal was consistent with the way in which we proposed to make the APM Incentive Payment to eligible clinicians who practice at locations other than Method II CAHs. We solicited comment on this proposal.
We did not receive any specific comments on this proposal, and we are finalizing our proposal to make the APM Incentive Payment for an eligible clinician who becomes a QP based on covered professional services furnished at a Method II CAH to the CAH TIN that is affiliated with the Advanced APM Entity.
As explained in section II.F.6.d.(2) of this final rule with comment, payment for services furnished by eligible clinicians in RHCs and FQHCs is not
We did not receive any specific comments on our proposal for eligible clinicians who become a QP who may also practice at an RHC or FQHC.
We are finalizing our proposal that professional services furnished in RHCs and FQHCs would not constitute covered professional services under section 1848(k)(3)(A) of the Act and would not be considered part of the amount upon which the APM Incentive Payment is based.
In the proposed rule, we proposed that the APM Incentive Payment would be made to QPs who are identified by their unique NPI. We proposed that we would make the APM Incentive Payment for a QP to the eligible clinician's TIN that is affiliated with the Advanced APM Entity through which the eligible clinician was determined to be a QP. For both individual eligible clinicians and group practices, we would use the TIN as the billing unit. We proposed that the APM Incentive Payment would be calculated across all billing TINs associated with an NPI. Medicare has the ability to track all unique TIN/NPI combinations associated with an individual NPI, including which TINs are affiliated with an Advanced APM Entity. We considered making separate payments for each TIN/NPI combination associated with the individual eligible clinician's APM Incentive Payment, similar to how the current PQRS incentive payment program operates. Under the current PQRS incentive payment program, incentive payments are paid to the holder of the TIN, aggregating individual incentive payments for groups that bill under one TIN. For eligible clinicians who submit claims under multiple TINs, we group claims by TIN for payment purposes, and any incentive payments earned are paid to that specific TIN. As a result, an eligible clinician with multiple TINs who qualifies for the PQRS incentive payment under more than one TIN would receive a separate PQRS incentive payment associated with each TIN.
However, we believe that making the APM Incentive Payments to the TIN associated with the Advanced APM Entity during the QP Performance Period would be most consistent with the requirements of section 1833(z) of the Act and would incentivize participation in Advanced APMs. Rewarding TINs that are not involved in an Advanced APM for their constituent NPI's activities through separate entities is antithetical to the objective of the Quality Payment Program. We also believe that making the APM Incentive Payments to the TIN associated with the Advanced APM Entity during the QP Performance Period is most consistent with section 1833(z) of the Act with regards to making the APM Incentive Payments to eligible clinicians who become QPs. We believe that making multiple separate payments would increase complexity for both CMS and eligible clinicians.
Additionally, we finalized in section II.F.5. of this final rule with comment, that to be a QP, an eligible clinician must be identified on a CMS-maintained Participation List of an Advanced APM Entity. That will allow us to track the APM participant identifiers for each eligible clinician, and we believe that this information will allow us to determine which of the QPs' TINs should receive APM Incentive Payments.
We recognize that there may be scenarios in which an eligible clinician may change his or her affiliation between the QP Performance Period and the payment year such that the eligible clinician no longer practices at the TIN affiliated with the Advanced APM Entity. In this instance, we proposed to make the APM Incentive Payment to the TIN provided on the eligible clinician's CMS-588 EFT Application. This proposal is consistent with the process that we have used to make incentive payments under other programs, such as the PCIP program.
We solicited comment on our proposal to make the APM Incentive Payments to the TIN affiliated with the Advanced APM Entity through which an individual eligible clinician becomes a QP and our proposal to make the APM Incentive Payment to the TIN provided on the eligible clinician's CMS-588 EFT Application in the event that an eligible clinician no longer practices at the TIN affiliated with the Advanced APM Entity at the time of payment. We also solicited comment on alternative options that maintain the goals of equity and simplicity and encourage and reward participation in Advanced APMs.
The following is a summary of the comments we received regarding our proposal to make the APM Incentive Payment to the TIN affiliated with the APM Entity through which an eligible clinician becomes a QP.
We received several comments suggesting alternatives to our proposal. Some commenters stated that they believe the APM Incentive Payment should be made directly to the QP, as identified by either the QP's NPI or by the QP's unique TIN/NPI combination. Some commenters also cited statutory language in section 1833(z) of the Act stating that APM Incentive Payments should be made to “such professionals.” Some of the commenters also stated that paying eligible clinicians directly will encourage them to become more engaged in an Advanced APM and its potential impact on patient care. One commenter stated that eligible clinicians have more control over their performance and can respond more quickly to incentives.
Conversely, we received some comments stating that the APM Incentive Payment should be made to the Advanced APM Entity TIN, similar to how shared savings payments are
Even in instances where an incentive payment has been calculated at an NPI level, CMS has traditionally used the TIN as the billing unit such that any incentive payments earned are paid to the TIN holder of record. This precedent has been followed in various other incentive payment programs, such as the Physician Quality Reporting Initiative (PQRI) incentive payment and the PQRS incentive payment program, and we intend to follow this established precedent of making incentive payments to billing TINs. However, under those incentive payment programs, CMS grouped eligible clinician' claims by TIN for payment purposes, and any incentive payments earned were paid to that TIN. As a result, an eligible clinician with multiple TINs who qualified for an incentive payments under more than one TIN would have received a separate incentive payment associated with each TIN.
We believe that making the APM Incentive Payments to the TIN associated with the Advanced APM Entity through which an eligible clinician becomes a QP would be most consistent with the requirements of section 1833(z) of the Act and would incentivize participation in Advanced APMs. We also believe that making the APM Incentive Payments to the TIN associated with the Advanced APM Entity during the QP Performance Period is most consistent with section 1833(z) of the Act with regards to making the APM Incentive Payments to eligible clinicians who become QPs.
Given the precedent of making incentive payments to the TIN holder of record, we will make APM Incentive Payments to the Medicare-enrolled billing TIN of a QP's NPI that is in the Advanced APM Entity. We do not prescribe whether or how APM Incentive Payments are to be distributed to QPs within the TIN.
After considering public comments, we are finalizing our proposal to make the APM Incentive Payment to the TIN affiliated with the Advanced APM Entity through which an eligible clinician becomes a QP, and we further clarify that the APM Incentive Payment would be sent to the Medicare-enrolled billing TIN associated with the Advanced APM Entity. As discussed in our responses to comments, we note that all Medicare payments are made to a billing TIN, and the ultimate distribution of the APM Incentive Payment is a consideration of the Medicare-enrolled billing TIN and their associated QPs. We are also finalizing our proposal to make the APM Incentive Payment to the TIN provided on the eligible clinician's CMS-588 EFT Application in the event that an eligible clinician no longer practices at the TIN affiliated with the Advanced APM Entity at the time of payment. QP status is determined for, and attached to, an eligible clinician for the payment year based on Advanced APM participation during the QP Performance Period; therefore, changes in practice afterward should not affect a QP's ability to receive the APM Incentive Payment or to be excluded from MIPS reporting requirements and payment adjustments.
We recognize that there may be instances where none of the multiple Advanced APM Entities with which an individual eligible clinician participates meets the QP threshold. In this instance, we have proposed to assess the eligible clinician individually, using services furnished through all Advanced APM Entities during the QP Performance Period. When we make the QP determination at the individual eligible clinician level, we proposed to split the APM Incentive Payment amount proportionally across all of the QP's TINs associated with Advanced APM Entities. For example, if an eligible clinician is determined to be a QP at the individual level based on participation in two Advanced APM Entities (Advanced APM Entity 1 and Advanced APM Entity 2), and has 75 percent of his or her payments used to make the QP determination are through Advanced APM Entity 1 and 25 percent of his or her payments used to make the QP determination are through Advanced APM Entity 2, we would make 75 percent of the APM Incentive Payment to the QP's billing TIN associated with Advanced APM Entity 1, and 25 percent of the APM Incentive Payment to the QP's billing TIN affiliated with Advanced APM Entity 2. We believe that splitting the APM Incentive Payment in this way is consistent with section 1833(z) of the Act as well as our goal to encourage participation in multiple Advanced APMs where applicable. We also believe that splitting the incentive payment in this way appropriately recognizes the several activities of the individual eligible clinician toward achieving the QP threshold.
We solicited comment on the proposal to split the APM Incentive Payment among the QP's TINs associated with Advanced APM Entities in instances where the QP determination is made at the individual level based on participation in multiple Advanced APMs. We also welcomed comments regarding to which TIN(s) payments should be made in the cases where the QP changes TIN affiliations between the QP Performance Period and the payments of the APM Incentive Payment.
We did not receive any comments with regards to our proposal to split the APM Incentive Payment among a QP's TINs associated with Advanced APM Entities in instances where the QP determination is made at the individual eligible clinician level.
Some commenters questioned why, in the event an eligible clinician is no longer associated with the TIN associated with the Advanced APM Entity, the APM Incentive Payment would be made to a new entity, and questioned why the APM Incentive Payment would not stay with the billing TIN participating in the Advanced APM Entity. In this instance, the commenter suggested we split the payment amount based on either the predominance of where that clinician provided services or based on an end date.
We are finalizing the proposal to split the APM Incentive Payment amount proportionally, based on the payment amounts used to make the QP determination across all of the QP's TINs associated with Advanced APM Entities when the QP determination is made at the individual level.
We also further clarify that in the event that an eligible clinician participates in more than one Advanced APM Entity, and that eligible clinician meets the QP threshold through more than one Advanced APM Entity, as determined at the group level, we would split the total amount of the APM Incentive Payment in the same manner.
We proposed to send notification to both Advanced APM Entities and QPs of the APM Incentive Payment amount as soon as we have calculated the amount of the APM Incentive Payment and performed all necessary validation of the results. Following our proposed method to notify eligible clinicians of their QP status, we proposed that the APM Incentive Payment amount notification would be made directly to QPs in combination with a general public notice that such calculations have been completed for the year. For the direct QP notification, we intended to include the amount of APM Incentive Payment and the TIN to which the incentive payments will be made. In the case that the APM Incentive Payment is split across multiple TINs, we proposed to identify which TINs would receive the payment and include the amount that would be paid to each TIN. For the notification to Advanced APM Entities, and other recipient TINs, we intend to include the total amount of APM Incentive Payments that will be made to each participating TIN within the Advanced APM Entity, as well as QP-specific payment amounts. We believed that this would be the most efficient method to disseminate of this information to all QPs.
We solicited comment on other methods for the notification of the APM Incentive Payment amount. We also solicited comment on the content of such notifications so that they may be as clear and useful as possible.
The following is a summary of the comments we received regarding our proposal to notify Advanced APM Entities and QPs of the amount of the APM Incentive Payment.
After considering public comments, we are finalizing our proposal to send a notification to both Advanced APM Entities and QPs of the APM Incentive Payment amount as soon as CMS has calculated the amount of the APM Incentive Payment and performed all necessary validation of the results as proposed.
In an effort to accurately award the APM Incentive Payment and preserve the integrity of the Medicare program, we will monitor APM Entities, Advanced APM Entities, and eligible clinicians on an ongoing basis for non-compliance with Medicare program requirements and for non-compliance with the law, regulation, or agreement governing the relevant Advanced APMs during the QP Performance Period. These efforts include vetting of the individuals and entities applying to participate in Advanced APMs and periodically assessing Advanced APM Entities and eligible clinicians by Advanced APMs in conjunction with the CMS Center for Program Integrity and other relevant federal departments and agencies. This vetting and monitoring already takes place for APMs and will continue.
We proposed that if an Advanced APM terminates an Advanced APM Entity or eligible clinician during the QP Performance Period for program integrity reasons, or if the Advanced APM Entity or eligible clinician is out of compliance with program requirements, we may reduce or deny the APM Incentive Payment to such eligible clinicians. In addition, if the APM Incentive Payment is paid based on a QP Performance Period and the Advanced APM Entity or eligible clinician is later terminated due to a program integrity matter arising during that QP Performance Period, we may recoup all or a portion of the amount of the APM Incentive Payment from the individual or entity to which we made the payment.
We also proposed that we would reopen and recoup any payments that
As discussed in section II.F.7.b.(7) of this final rule with comment period, APM Entities or eligible clinicians who seek to be assessed under the All-Payer Combination Option must submit certain information for us to assess whether their other payer arrangements meet the Other Payer Advanced APM criteria and to calculate the Threshold Score for a QP determination under the All-Payer Combination Option.
Relatedly, we proposed that Advanced APM Entities and eligible clinicians must maintain copies of all records related to assessment under the All-Payer Combination Option for at least 10 years from the time of submission and must provide the government with access to these records for auditing and inspection purposes. If an audit reveals that the information submitted is inaccurate, we may recoup the APM Incentive Payment.
Nothing in this final rule imposes any limitations or restrictions on the authority of the Department of Health and Human Services Office of Inspector General.
We solicited comment on our monitoring and program integrity proposals.
The following is a summary of the comments we received regarding our proposals to continue CMS vetting of those applying to be and ongoing monitoring of those Advanced APM Entities and eligible clinicians.
We are finalizing our proposals to vet and monitor APM Entities, Advanced APM Entities, and eligible clinicians.
The following is a summary of the comments we received regarding our proposals to deny, reduce, or recoup APM Incentive Payments made to eligible clinicians if an Advanced APM Entity or eligible clinician is either out of compliance with the Advanced APM's program requirements or if the Advanced APM Entity or eligible clinician is terminated from participating in the APM for program integrity reasons and to reopen and recoup any payments that were made in error in accordance with procedures similar to those set forth at §§ 405.980 and 405.370
Providers or suppliers who wish to voluntarily disclose self-discovered evidence of potential fraud to CMS or the Office of Inspector General may do so under their respective self-disclosure protocols.
We are finalizing our proposals with no changes. We will deny, reduce, or recoup APM Incentive Payments made to eligible clinicians if an Advanced APM Entity or eligible clinician is either out of compliance with the Advanced APM's program requirements or if the Advanced APM Entity or eligible clinician is terminated from participating in the APM for program integrity reasons and to reopen and recoup any payments that were made in error in accordance with procedures similar to those set forth at §§ 405.980 and 405.370
The following is a summary of the comments we received regarding our proposal to require that all Advanced APM Entities and eligible clinicians who submit information in order to obtain a QP determination under the All-Payer Combination Option retain all records, and provide the government with access to these records for auditing and inspection purposes, for at least 10 years.
In order to address the requests for more detail, we intend to issue further details regarding the All-Payer Combination Option before the 2019 QP Performance Period, which is when it first becomes available.
We are finalizing that Advanced APM Entities and eligible clinicians must retain, maintain, and provide the government with access to copies of all records related to submitting data or information to CMS for purposes of QP determinations under the All-Payer Combination Option for at least 10 years from the date that the record was created. We clarify that for any single record, the responsibilities finalized here may be carried out by either an Advanced APM Entity or an eligible clinician so that collectively, all necessary records are retained, maintained, and accessible to the government.
Section 101(e)(1) of the MACRA statute entitled, “Increasing the Transparency of Physician-Focused Payment Models,” adds a new section 1868(c) to the Act. In general, this subsection establishes an innovative process for individuals and stakeholder entities (stakeholders) to propose PFPMs to the Physician-Focused Payment Model Technical Advisory Committee (PTAC). A copy of the PTAC's charter, established by the Secretary on January 5, 2016, is available at
Section 1868(c)(2)(A) of the Act requires the Secretary to establish, through notice and comment rulemaking following an RFI, criteria for PFPMs (PFPM criteria), including models for specialist physicians, that could be used by the PTAC in making comments and recommendations on PFPMs. We issued the MIPS and APMs RFI requesting stakeholder input on PFPMs on October 1, 2015, and we proposed PFPM criteria in section II.F.10.c. of the Quality Payment Program proposed rule.
The PTAC, established under section 1868(c)(1)(A) of the Act, is a federal advisory committee comprised of 11 members that provides independent advice to the Secretary. As required under section 1868(c)(1)(B) of the Act, the initial appointments to the PTAC were made by the Comptroller General of the United States (GAO) on October 9, 2015.
Section 1868(c)(2)(B) of the Act specifies that stakeholders may submit proposals to the PTAC on an ongoing basis for PFPMs that they believe meet the PFPM criteria established by the Secretary. We recognize this statutory directive, but did not propose to define “ongoing basis” because we believe that the process for submitting proposals to the PTAC should be determined by the PTAC.
Section 1868(c)(2)(C) of the Act requires the PTAC to review stakeholders' proposed PFPMs, prepare comments and recommendations regarding whether such proposed PFPMs meet the PFPM criteria established by the Secretary, and submit those comments and recommendations to the Secretary.
Section 1868(c)(2)(D) of the Act requires the Secretary to review the PTAC's comments and recommendations on proposed PFPMs and to post “a detailed response” to those comments and recommendations on the CMS Web site.
Without being able to predict the volume, quality, or appropriateness of the proposed PFPMs that the PTAC will make comments and recommendations on, we are not in a position to propose a commitment to test all such models. Section 1868(c) of the Act does not require us to test models that are recommended by the PTAC. However, this does not imply that we would not give serious consideration to proposed PFPMs recommended by the PTAC.
The PTAC serves an important advisory role in the implementation of PFPMs, but there are additional considerations that must be made by the Secretary beyond what is provided by the PTAC, such as competing priorities and available resources. We believe that this flexibility is important because the Secretary and CMS must retain the ability to make final decisions on which models to test and when, based on multiple factors including those that the Innovation Center currently uses to determine which payment models to test, available on the Innovation Center Web site:
While we would consider these factors separately from the PTAC's comments and recommendations, the decision to test a model recommended by the PTAC would not require submission of a second proposal to us; we would review the proposal submitted to the PTAC along with comments from the PTAC and the Secretary, and any other resources we believe would be useful. In order to test
Proposed PFPMs that the PTAC recommends to the Secretary but that are not immediately tested by us may be considered for testing at a later time. We may continue to test PFPMs that are developed within CMS but believe that the PTAC process will be instrumental in our goal to develop more PFPMs.
We did not propose to set deadlines for these tasks through regulations. We believe that setting a deadline for the PTAC's comments and recommendations could potentially interfere with the PTAC's ability to develop its own process and timeline for reviewing proposed PFPMs. We wish to preserve the PTAC's ability to determine how and when it would review proposed PFPMs.
We believe that setting a deadline through rulemaking for the Secretary's review of the PTAC's comments and recommendations, publication of a response to them, and our potential testing of a proposed PFPM submitted to the PTAC is inappropriate because these tasks would take varying amounts of time depending on factors that we cannot predict. Proposed PFPMs may be submitted to the PTAC on “an ongoing basis” in accordance with section 1868(c)(2)(B) of the Act, and given that there may be variation in the number and frequency of proposals, setting a deadline for the Secretary's response would be difficult. We do not believe we can effectively set deadlines through rulemaking because we do not know how many PFPM proposals the PTAC would receive or review. The Secretary would need varying lengths of time to review, comment on, and respond to PFPM proposals depending on the volume and nature of each proposal.
We do not believe it would be reasonable to require that we adhere to a deadline in deciding whether to test a particular proposed PFPM. It is important for us to retain the flexibility to test APMs when we believe that it is the right time to do so, taking into account the other APMs we are currently testing, any potential design changes to the proposed PFPM, interactions with our other policies, and resource allocation. APMs generally take 18 months for us to develop, although the period of development may vary in length significantly, making a deadline difficult to establish.
We believe that setting deadlines for testing proposed PFPMs would be inappropriate. Entities need time to complete applications for voluntary models and we need time to review applications and prepare participation agreements for entities to sign. Entities need time to review these participation agreements and to begin planning for implementation of the model. To maintain rigorous evaluation of model outcomes, we also need time to build the necessary model infrastructure for such functions as quality measurement, financial calculations, and payment disbursements, and to coordinate with other payers if they are included in the model's design.
We believe that proposed PFPMs that meet all of the PFPM criteria and are recommended by the PTAC may need less time to go through the development process; however, we cannot guarantee that the development process would be shortened, or estimate by how much it would be shortened. These processes depend on the nature of the PFPM's design, and any attempt to impose a deadline on them would not benefit stakeholders because it would not allow us to tailor the review and development process to the needs of the proposed PFPM.
The following is a summary of the comments we received regarding the roles of the Secretary, the PTAC, and CMS.
Section 1868(c) of the Act does not define the term “physician-focused payment model” (PFPM). In § 414.1465 of the proposed regulatory text, we proposed to add the following definition of PFPM: An Alternative Payment Model wherein Medicare is a payer, which includes physician group practices (PGPs) or individual physicians as APM Entities and targets the quality and costs of physicians' services. We proposed to require that a PFPM target physicians' services to meet the definition of PFPM. To address physicians' services, we proposed PFPMs might address such elements as physician behavior or clinical decision-making. APM Entities may be individual eligible clinicians, physician group practices (PGPs), or other entities, depending on the payment model's design. We proposed a PFPM must focus on physicians' services and contain either individual physicians or PGPs as APM Entities, although it might also include facilities or other practitioner types.
We proposed to require that PFPMs be designed to be tested as APMs with Medicare as a payer. Other Payer APMs would therefore not be PFPMs. We believe this is an appropriate standard for PFPMs because the Secretary is interested in reviewing comments and recommendations from the PTAC on models that may be tested with Medicare as a payer and because the statutory provisions regarding PFPMs and the PTAC are within section 1868 of the Act and title XVIII of the Act, which governs Medicare. A PFPM may include other payers in addition to Medicare under the proposed definition. We believe this definition is appropriate because it could include APMs with arms of their design that would include other payers beyond Medicare, but would not include models that involve only Other Payer APMs.
We did not propose to limit a PFPM to exclusively targeting physicians and physicians' services because we believe that stakeholders should be able to propose payment models that include additional types of entities, as well as additional services. We did not propose to define PFPM as an APM that exclusively addresses Medicare FFS payments. A proposed PFPM may also include other payers in addition to Medicare, including Medicaid, Medicare Advantage, CHIP, and private payers, which may promote broader participation in PFPMs and greater potential for cost reduction. A PFPM that includes payers in addition to Medicare could potentially include an Other Payer Advanced APM as part of its design in addition to being an APM.
Section 1868(c) of the Act does not require PFPMs to meet the criteria to be an Advanced APM for purposes of the incentives for participation in Advanced APMs under section 1833(z) of the Act, and we did not propose to define PFPMs solely as Advanced APMs. Stakeholders may therefore propose as PFPMs either Advanced APMs or other APMs that might lead to better care for patients, better health for our communities, and lower health care spending.
The following is a summary of the comments we received regarding our proposal to define Physician-Focused Payment Model as an APM wherein Medicare is a payer, which includes physician group practices (PGPs) or individual physicians as APM Entities and targets the quality and costs of physicians' services.
If a PFPM meets criteria for Advanced APMs under section 1833(z)(3)(D) of the Act, as finalized in this rule, it is an Advanced APM. The criteria for Advanced APMs are specified by statute: The APM must require participants to use certified EHR technology; the APM must provide for payment for covered professional services based on quality measures comparable to those in the quality performance category under MIPS; and the APM must either require that participating APM Entities bear risk for monetary losses of a more than nominal amount under the APM, or be a Medical Home Model expanded under section 1115A(c) of the Act. For example, if a model is tested under section 1115A of the Act and it is not a health care innovation award, it is by definition an APM. If it is tested under section 1115A of the Act, is not a health care innovation award, and meets the criteria for Advanced APMs, it is an Advanced APM. We will not categorically waive the requirements for Advanced APMs for PFPMs we test. Section 1833(z)(3)(C) and (D) of the Act makes a clear distinction between APMs and Advanced APMs, and we do not believe the statutory requirements for Advanced APMs can or should be categorically waived for PFPMs. We retain the flexibility to consider and test PFPMs that are developed within CMS.
For the QP determination timeline, we note that under the proposed and final policies in section II.F.5. of this final rule with comment period, participation in a PFPM that is determined to be an Advanced APM for 2017, which is the QP Performance Period for the 2019 APM Incentive Payment, offers the opportunity for participants to become QPs. Because eligible clinicians would have the opportunity to become QPs through participation in PFPMs that are Advanced APMs in the same way they would through participation in other Advanced APMs, we do not believe it would be appropriate to modify the QP determination process and APM Incentive Payment timeframe. Further, as stated in section II.F.5. of this final rule with comment period, the exclusion of QPs from MIPS reporting requirements and payment adjustments dictates an operational timeline that permits us to determine and communicate an eligible clinician's status for a payment year (whether QP, Partial QP, or MIPS eligible clinician) to facilitate timely decisions that impact payment and budget neutrality for the relevant payment year. We do not believe this operational timeline would allow us to retrospectively exclude eligible clinicians from MIPS adjustments already in effect based on later participation in a PFPM that is an Advanced APM.
In response to the comments requesting that we include a broader category of clinicians than physicians in PFPMs and that PFPMs be flexible in their focus on the leadership and decision-making of such clinicians, we have changed the definition of PFPM to not require that PGPs or individual physicians be included as APM Entities. Instead, PFPMs must give eligible clinicians a core role in implementing the payment methodology. In response to the comments, we are changing the definition of PFPMs to include models that include any eligible clinicians that fall under the definition of EP in section 1848(k)(3)(B) of the Act. We are also changing the definition to include models that address the services of all clinicians that fall under the definition of EP within section 1848(k)(3)(B) of the Act. We are finalizing our proposal not to limit PFPMs to Advanced APMs but instead to include models that, if tested, would be APMs and could potentially be Advanced APMs.
We are finalizing the definition of PFPM to mean an APM: (1) In which Medicare is a payer; (2) in which eligible clinicians that are EPs as defined in section 1848(k)(3)(B) of the Act are participants and play a core role in implementing the APM's payment methodology, and (3) which targets the quality and costs of services that eligible clinicians participating in the Alternative Payment Model provide, order, or can significantly influence.
Section 1868(c)(2)(A) of the Act requires the Secretary to establish criteria for PFPMs, including models for specialist physicians, not later than November 1, 2016. The PFPM criteria would be used by the PTAC in discharging its duties under section 1868(c)(2)(C) of the Act to make comments and recommendations to the Secretary on proposed PFPMs. The proposed PFPM criteria were listed in section II.F.10.c.(1). of the proposed rule and at § 414.1465(b) of the proposed regulatory text. We designed the proposed criteria to be broad enough to encompass all physician specialties and provide stakeholders with flexibility in designing PFPMs.
We proposed PFPM criteria organized into three categories that are consistent with the Administration's strategic goals for achieving better care, smarter spending and healthier people: Payment incentives; care delivery; and information availability. First, we proposed a category of criteria that promote payment incentives for higher-value care, including paying for value over volume and providing resources and flexibility necessary for practitioners to deliver high-quality health care.
To address paying for value over volume, we proposed a criterion that PFPMs should provide incentives to practitioners to deliver high-quality health care, and that these incentives should be specifically expected to lead to high-quality health care. We believe that the correct incentives are necessary to drive change to improve quality of care. Similarly, we believe that it is important for a PFPM to provide sufficient flexibility for practitioners to deliver high-quality health care. Flexibility relates to operational feasibility, the PFPM's ability to adapt to accommodate clinical differences in patient subgroups, and the APM Entity's ability to respond to changes in health care.
This category of criteria also aligns with the Innovation Center's statutory authority under section 1115A of the Act to test models aimed to improve care, reduce expenditures, or achieve both of these goals, by proposing a criterion that assesses to what extent a PFPM proposal is expected to achieve these goals. We believe estimates of any cost reduction under the PFPM to the most precise extent possible would also be useful in addressing this criterion.
We proposed a criterion that the PFPM proposal must be designed to pay APM Entities under a payment methodology that furthers the PFPM Criteria. The payment methodology must address how it is different from current Medicare payment methodologies, and why the payment methodology cannot be tested under current payment methodologies. We believe it is necessary for PFPM proposals to contain such a payment methodology because the PTAC is tasked with reviewing payment models and therefore cannot evaluate a proposal without knowing the payment methodology.
We also proposed to include in the first category a criterion that the PFPM must either aim to solve an issue in payment policy not addressed in the CMS APM portfolio at the time it is proposed or include in its design APM Entities who have had limited opportunities to participate in APMs. For a list of models in the CMS APM portfolio, please see
We also proposed a criterion that a PFPM proposal must have evaluable goals for the impact of cost and quality under the PFPM. To make the decision
Second, we proposed a category of criteria that address care delivery improvements that promote better care. Here we proposed criteria to address integration and care coordination, patient choice, and patient safety.
Third, we proposed a category of criteria that address information enhancements that improve the availability of information to guide decision-making. We believe that information enhancements, particularly through use of technology are important to improving Medicare payment policy and delivering better care. Here we proposed a criterion for encouraging use of health information technology.
In carrying out its review of PFPM proposals, the PTAC shall assess whether the PFPM meets the following criteria for PFPMs sought by the Secretary as required by section 1868(c)(2)(C) of the Act. We proposed the following PFPM criteria. The Secretary seeks PFPMs that:
(1)
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•
•
•
•
•
(2)
•
•
•
(3)
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In the proposed rule, we described “supplemental information elements” that we find particularly useful in our review when we consider potential APMs. The “supplemental information” is meant to increase the transparency of our process and is not included within the PFPM criteria.
The following is summary of the comments we received regarding the Secretary's proposed PFPM criteria and the supplemental information.
We are finalizing our proposed criteria with one modification. We are broadening the proposed scope criterion. The final scope criterion now requires that PFPMs aim to broaden or expand the CMS APM portfolio by addressing an issue in payment policy in a new way or including APM Entities whose opportunities to participate in APMs have been limited. We are finalizing the other PFPM criteria as proposed.
Under the Paperwork Reduction Act of 1995, we are required to provide 30-day notice in the
• The need for the information collection and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our estimate of the information collection burden.
• The quality, utility, and clarity of the information to be collected.
• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
In the proposed rule (81 FR 28350 through 28364), we solicited public comment on each of the section 3506(c)(2)(A)-required issues for the following information collection requirements. PRA-related comments were received as indicated below under the relevant information collection requirements (ICRs).
In response to our request for public comment on our Information Collections, we received several general comments regarding the burden of data collection and the privacy of CMS information collection.
In summary, we are finalizing policies that further streamline reporting and reduce burden and have provided additional information to commenters on privacy protections in response to public comments.
The remainder of this section focuses on the estimated burden of clinicians and groups that submit data in response to information collections established by this final rule with comment period. This estimated burden is expressed in terms of time and labor costs. First, we discuss the wage estimates that are used to calculate the labor costs associated with data submission for all the information collection requirements established by this final rule with comment period. Second, we provide a framework summarizing how the information collection requirements vary by the type of data submitted and the type of respondent submitting the data (individual clinician, group, APM Entity, or APM billing TIN). Third, we provide burden estimate calculations for each of the information collection requirements established by this final rule with comment period. Finally, we calculate the total gross and net burden across all information collection requirements.
To derive wage estimates, we used data from the U.S. Bureau of Labor Statistics' (BLS) May 2015 National Occupational Employment and Wage Estimates. Table 42 presents the mean hourly wage, the cost of fringe benefits and overhead, and the adjusted hourly wages for billing and posting clerks, computer systems analysts, physicians, practice administrators, and licensed practical nurses as derived from this data. We believe these are the primary positions that will be involved in the collection and reporting of information under this regulation. We have adjusted these employee hourly wage estimates by a factor of 100 percent to reflect current HHS department-wide guidance on estimating the cost of fringe benefits and overhead. These are necessarily rough adjustments, 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 these are reasonable estimation methods. In addition, to calculate beneficiary time costs, we have used wage estimates for Civilian, all occupations, using the same BLS data discussed above. We have not adjusted these costs for fringe benefits and overhead because direct wage costs represent the “opportunity cost” to beneficiaries themselves for time spent in health care settings.
We added additional occupational titles to the list of occupational titles used in the proposed rule as part of our burden estimates here in order to better reflect the skill mix of the staff that we believe will take part in reviewing measure specifications. Specifically, we are adding practice administrator and licensed practical nurse (LPN) to this list. These changes were in response to comments discussed below under section III.C. ICRs Related to Quality Performance Category and Previously Approved under PQRS.
Because of the wide range of information collection requirements under MIPS, Table 43 presents a framework for understanding how the organizations permitted or required to submit data on behalf of clinicians varies across the types of data, and whether the clinician is a MIPS eligible clinician, MIPS APM participant, or an Advanced APM participant. As shown in the first row of Table 43, MIPS eligible clinicians that are not in MIPS APMs and other clinicians voluntarily submitting data will submit data either as individuals or groups to the quality, advancing care information, and improvement activities performance categories.
For MIPS APMs, the organizations submitting data on behalf of participating MIPS eligible clinicians will vary across categories of data, and in some instances across APMs. For the performance period in 2017, the quality data submitted by Shared Savings Program Accountable Care Organizations (ACOs) and Next Generation ACOs on behalf of their participants will fulfill both MIPS submission requirements for the quality performance category. For the advancing care information performance category, billing TINs will submit data on behalf of participants who are MIPS eligible clinicians. For the improvement activities performance category, we will assume no reporting burden for MIPS APM participants because CMS will assign the improvement activities performance category score at the MIPS APM level and all APM Entity groups in the same MIPS APM will receive the same score. Advanced APM participants who are determined to be Partial QPs will be required to submit elections as to whether they will participate in MIPS, which is discussed in more detail in section III.I. of this final rule with comment period.
We did
We anticipate that two groups of clinicians will submit quality data under MIPS, those who submit as MIPS eligible clinicians and other clinicians who opt to submit data voluntarily in, but will not be subject to MIPS payment adjustments. Based on 2015 data from the PQRS and other CMS sources,
Our burden estimates for quality data submission combine the burden for MIPS eligible clinicians and other clinicians submitting data voluntarily.
For clinicians or groups, the burden associated with the requirements of the MIPS quality performance category is the time and effort associated with clinicians identifying applicable quality measures, and submission of the measures.
The burden estimates were revised to reflect differences between the policies established in this final rule with comment period, and those proposed in the proposed rule. In addition, the burden estimates were revised in response to public comments about the underlying assumptions, which are discussed at the end of this section. As a result of these revisions, the gross burden estimate in the proposed rule was 12,493,654 burden hours with an associated burden cost of$1,327,177,693 (81 FR 28362). The finalized burden estimates are 10,894,214 burden hours with an associated burden cost of $1,311,245,806.
Several differences between the revised policies set forth in this final rule with comment period and the policies in the proposed rule are reflected in the burden estimates, including the reduction in the number of required advancing care information measures from 11 to five and the reduction in the number of recommended improvement activities from six to four. The burden estimates also reflect a simplification of the data submission requirements for MIPS APM participants. Specifically, this final rule with comment period does not generally require MIPS APM participants to submit improvement activities data, whereas the proposed rule did. For the advancing care information performance category, this final rule with comment period establishes the capability for participants in MIPS APMs other than the Shared Savings Program to submit data at the billing TIN level. In contrast, we had proposed that participants in Shared Savings Program ACOs submit advancing care information data at the billing TIN level and participants in other MIPS APMs submit advancing care information data at the individual clinician level.
Finally, under the revised policy set forth in this final rule with comment period, Advanced APM participants will be notified about their QP or Partial QP status before the end of the performance period, whereas in the proposed rule, Advanced APM participants would not have been notified of their QP or Partial QP status until after the end of the submission period. Due to the timing of the QP and Partial QP status data, the proposed rule's burden estimates assumed that all Advanced APM Entities would be required to submit Partial QP election data. In the final rule with comment period, we assume the vast majority of Advanced APM participants will not be required to submit Partial QP election data.
In addition to policy differences between the proposed rule and final rule with comment period, the burden estimates also reflect changes in methods. In response to public comments, we have changed our assumptions about the number of hours and skill mix of labor needed to review quality measure specifications. We have also changed our assumptions to more accurately reflect the efficiency gains from group reporting. In the proposed rule, we assumed that the burden per clinician was the same whether they submitted as an individual or as part of a group. In this final rule with comment period's burden estimates, we calculate the burden at the level of the respondent (group or individual clinician) submitting data, and assume the average burden per respondent is the same.
These burden estimates have some limitations. We believe it is difficult to quantify the burden accurately because clinicians and groups may have different processes for integrating quality data submission into their practices' work flows. Moreover, the time needed for a clinician to review quality measures and other information, select measures applicable to their patients and the services they furnish, and incorporate the use of quality data codes into the office workflows is expected to vary along with the number of measures that are potentially applicable to a given clinician's practice. Further, the final burden estimates are based on historical rates of participation in the PQRS program, and the rate of participation in MIPS are expected to differ.
We believe the burden associated with actually submitting the quality measures will vary depending on the submission method selected by the clinician or group. As such, we break down the burden estimates by clinicians and groups according to the submission method used.
We anticipate that clinicians and groups using claims, QCDR and registry, and EHR submission mechanisms will have the same start-up costs related to reviewing measure specifications. As such, we estimate for clinicians and groups using any of these three submission mechanisms a total of 8 staff hours needed to review the quality measures list, review the various submission options, select the most appropriate submission option, identify the applicable measures or specialty measure sets for which they can report the necessary information, review the measure specifications for the selected measures or measures group, and incorporate submission of the selected measures or specialty measure sets into the office work flows. Building on data in a recent
For the purposes of our burden estimates for the claims, registry and QCDR, and EHR submission mechanisms, we also assume that, on average, each clinician or group will submit six quality measures. Given the lack of historical data on MIPS, it is difficult to estimate the number of physicians who will voluntary elect to test this system by submitting fewer than the six measures required for many clinicians. We believe that the number of clinicians and groups that submit fewer than six measures as they gain experience with the new system may be balanced out by the number of clinicians and groups that continue to submit more than six measures because they were required to submit nine measures under the PQRS.
The revised quality performance requirements and burden estimates were submitted along with all other ICRs listed below under a new OMB control number (0938-NEW). Given that in the first year of implementation CAHPS for MIPS is replacing and using the same questions as CAHPS for the PQRS, the CAHPS for MIPS performance requirements and burden estimates were submitted as a request for continuation of OMB control number (0938-1222), CAHPS for PQRS.
We received several general comments on the quality performance category burden estimates.
In summary, CMS made several changes to the quality performance category data burden estimates in response to comments, including increasing our estimate of the time required to review measure specifications from 7 to 8 hours, and assuming that a broader and more skilled mix of occupational titles would be needed to review measure specifications. In addition, the burden estimates were revised to reflect updated 2015 wage and PQRS data, and to more accurately reflect the burden of group reporting.
As noted above, we assume that 332,729 individual clinicians will submit quality data via claims based on 2015 PQRS data. We anticipate the claims submission process for MIPS will be operationally similar to the way it functioned under the PQRS. Specifically, clinicians will need to gather the required information, select the appropriate quality data codes (QDCs), and include the appropriate QDCs on the claims they submit for payment. Clinicians will collect QDCs as additional (optional) line items on the CMS-1500 claim form or the electronic equivalent HIPAA transaction 837-P, approved by OMB under control number 0938-0999.
The total estimated burden of claims-based submission will vary along with the volume of claims on which the submission is based. Based on our experience with the PQRS, we estimate that the burden for submission of quality data will range from 0.22 hours to 10.8 hours per clinician. The wide range of estimates for the time required for a clinician to submit quality measures via claims reflects the wide variation in complexity of submission across different clinician quality measures. As shown in Table 44, we also estimate that the cost of quality data submission using claims will range from $19.08 (0.22 hours × $86.72) to $936.58 (10.8 hours × $86.72). The total estimated annual cost per clinician ranges from the minimum burden estimate of $878.60 to a maximum burden estimate of $1,796.10. The burden will involve becoming familiar with MIPS data submission requirements. We believe that the start-up cost for a clinician's practice to review measure specifications total 8, which includes 3 hours of a practice administrator's time (3 hours × $101.98 = $305.94), 2 hours of a clinician's time (2 hours × $194.66/hour = $389.32), 1 hour of a LPN/medical assistant's time (1 hour × $42.34 = $42.34), 1 hour of a computer systems analyst's time (1 hour × $86.72 = $86.72), and 1 hour of a billing clerk's time (1 hour × $35.20/hour = $35.20). These start-up costs pertain to the specific quality submission methods below, and hence appear in the burden estimate tables.
Considering both data submission and start-up costs, the total estimated burden hours per clinician ranges from a minimum of 8.22 hours (0.22 + 3 + 2 + 1 + 1 + 1) to a maximum of 18.8 hours (10.8 + 3 + 2 + 1 + 1 + 1). The total estimated annual cost per clinician ranges from the minimum estimate of $878.60 ($19.08 + $305.94 + $389.32 + $42.34 + $86.72 + $35.20) to a maximum estimate of $1,796.10 ($936.58 + $305.94 + $389.32 + $42.34 + $86.72 + $35.20). Therefore, total annual burden cost is estimated to range from a minimum burden estimate of $292,335,167 (332,729 × $878.60) to a maximum burden estimate of $597,613,226 (332,729 × $1,796.10).
Based on the assumptions discussed above, Table 44 summarizes the range of total annual burden associated with clinicians using the claims submission
We did not receive comments specific to the claims-based submission burden. We have updated the numbers to reflect updates based on 2015 data and to reflect new assumptions on the staff time required to review measure specifications, but no other changes were made.
As noted above, we assume that 258,993 clinicians will submit quality data as individuals or groups via qualified registry or QCDR submissions based on 2015 PQRS data. Of these, we expect 119,201 clinicians to submit as individuals and 2,678 groups are expected to submit on behalf of the remaining 139,792 clinicians. Given that the number of measures required is the same for clinicians and groups, we expect the burden to be the same for each respondent submitting data via qualified registry or QCDR, whether the clinician is participating in MIPS as an individual or group.
We estimate that burdens associated with QCDR submissions are similar to the burdens associated with qualified registry submissions. Therefore, we discuss the burden for both data submissions together below. For qualified registry and QCDR submissions, we estimate an additional time burden for respondents (clinicians and groups) to become familiar with MIPS submission requirements and, in some cases, new specialty measure sets. Therefore, we believe that the start-up cost for an individual clinician or group to review measure specifications and report quality data to total $1,126.88. This total includes 3 hours per respondent to submit quality data (3 hours × $86.72/hour = $260.16), 3 hours of a practice administrator's time (3 hours × $101.98/hour = $305.94), 2 hours of a clinician's time (2 hours × $194.66/hour = $389.32), 1 hour of a computer systems analyst's time (1 hour × $86.72/hour = $86.72), 1 hour of LPN/medical assistant's time, (1 hour × $42.34/hour = $42.34), and 1 hour of a billing clerk's time (1 hour × $35.20/hour = 35.20). Clinicians and groups will need to authorize or instruct the qualified registry or QCDR to submit quality measures' results and numerator and denominator data on quality measures to CMS on their behalf. We estimate that the time and effort associated with authorizing or instructing the quality registry or QCDR to submit this data will be approximately 5 minutes (0.083 hours) per clinician or group (respondent) for a total burden cost of $7.20, at a computer systems analyst's labor rate (.083 hours × $86.72/hour). Hence, we estimate 11.083 burden hours per respondent, with annual total burden hours of 1,350,785 (11.083 burden hours × 121,879 respondents). The total estimated annual cost per respondent is estimated to be approximately $1,126.88. Therefore, total annual
The following is a summary of the comments we received regarding our burden estimate for the quality performance category using registry or QCDR.
In summary, no changes were made to the registry or QCDR data submission burden estimate in response to comments specific to that section. We have updated the numbers to reflect updates based on 2015 data and to reflect new assumptions on group submission and the staff time required to review measure specifications.
As noted above, based on 2015 PQRS data, we assume that 105,987 clinicians will submit quality data as individuals or groups via EHR submissions; 51,527 clinicians are expected to submit as individuals; and 903 groups are expected to submit on behalf of 54,460 clinicians. We expect the burden to be the same for each respondent submitting data via qualified registry or QCDR, whether the clinician is participating in MIPS as an individual or group.
Under the EHR submission mechanism, the individual clinician or group may either submit the quality measures data directly to CMS from their EHR or utilize an EHR data submission vendor to submit the data to CMS on the clinician's or group's behalf.
Based on our experience with the PQRS, we estimate that the time needed to perform all the steps necessary for clinicians or groups to submit quality performance measures includes the time to prepare for participating in quality performance category submissions for MIPS calculated at 8 hours of time to for reviewing specifications: (3 hours of a practice administrator's time, 2 hours of clinician's time, 1 hour of a LPN/medical assistant's time, plus 1 hour of a billing clerk's time). The time preparing for participating in EHR data submission also includes 1 hour for the respondent to obtain an account in the CMS identity management system plus 1 hour for submission of a test data file. This means the final step for quality data via an EHR submission mechanism is an additional 2 hours for data submission.
To prepare for the EHR submission mechanism, the clinician or group must review the quality measures on which we will be accepting MIPS data extracted from EHRs, select the appropriate quality measures, extract the necessary clinical data from their EHR, and submit the necessary data to the CMS-designated clinical data warehouse or use a health IT vendor to submit the data on behalf of the clinician or group. We assume the burden for submission of quality measures data via EHR is similar for clinicians and groups who submit their data directly to CMS from their CERHT and clinicians and groups who use an
Based on these burden requirements and the number of clinicians and groups historically using the EHR submission mechanism, we have calculated a burden estimate for the quality data submission using EHR submission mechanism:
We did not receive comments specific to the EHR submission burden. We have updated the numbers to reflect updates based on 2015 data and to reflect new assumptions on the staff time required to review measure specifications, but no other changes were made.
Based on 2015 PQRS data and 2016 Shared Savings Program and Next Generation ACO participation data, we assume that 750 organizations will submit quality data via the CMS Web Interface in the 2017 performance period (299 groups, 433 Shared Savings Program ACOs, and 18 Next Generation ACOs). Approximately 272,369 clinicians will be represented (107,885 clinicians not participating in ACOs; 140,341 Shared Savings Program participants, and 24,144 Next Generation ACO participants). Groups interested in participating in MIPS using the CMS Web Interface must complete a registration process, whereas Shared Savings Program ACOs and Next Generation ACOs do not need to complete a separate registration process. We estimate that the registration process for groups under MIPS involves approximately 1 hour of administrative staff time per group. The weighted average of the time required to register for the CMS Web Interface across all organizations is 0.40 hours (1 hour for each of the 299 groups and zero hours for each of the 433 Shared Savings Program ACOs or 18 Next Generation ACOs.) We assume that a billing clerk will be responsible for registering the group and that therefore, this process has an average labor cost of $35.20 per hour. Therefore, assuming the total burden hours per group associated with the group registration process is 1 hour, we estimate the total cost to a group
The burden associated with the group submission requirements under the CMS Web Interface is the time and effort associated with submitting data on a sample of the organization's beneficiaries that is prepopulated in the CMS Web Interface. Based on experience with PQRS GPRO Web Interface submission mechanism, we estimate that, on average, it will take each group 79 hours of a computer system analyst's time to submit quality measures data via the CMS Web Interface at a cost of $86.72 per hour, for a total cost of $6,850.88 (79 hours × $86.72/hour).
Our estimate of 79 hours for submission includes the time needed for each group to populate data fields in the web interface with information on approximately 248 eligible assigned Medicare beneficiaries and then submit the data (CMS will partially pre-populate the CMS Web Interface with claims data from their Medicare Part A and B beneficiaries). The patient data can either be manually entered or uploaded into the CMS Web Interface via a standard file format, which can be populated by CEHRT. Because each group must provide data on 248 eligible assigned Medicare beneficiaries (or all eligible assigned Medicare beneficiaries if the pool of eligible assigned beneficiaries is less than 248), we are assuming that entering or uploading data for one Medicare beneficiary requires 19 minutes of a computer systems analyst's time (79 hours ÷248 patients).
We also estimate that for each organization (group or ACO) submitting data, a clinician will need to spend 1 hour per year to review quality measure specifications, for a total cost of $194.66. The estimated time for reviewing quality measure specifications is lower than under the quality submission mechanisms because the CMS Web Interface measures are very similar to the GPRO Web Interface measures used in the 2016 PQRS. As mentioned above, we estimate it will take an average of 0.40 hours for each organization to register to submit through the CMS Web Interface, for a total of cost of $14.03 (0.40 × $35.20). The cost of these 1.40 hours is included in the total estimated annual cost per organization of $7,059.57. The total annual burden hours are estimated to be 60,299 (750 organizations × 80.40 annual hours), and the total annual burden cost is estimated to be $5,294,680 (750 organizations × $7.059.57).
Based on the assumptions discussed above we have calculated the following burden estimate for groups, Shared Savings Program ACOs, and Next Generation ACOs submitting to MIPS with the CMS Web Interface.
We did not receive comments specific to the Web Interface submission reporting burden. We have updated the numbers to reflect updates based on 2015 data, but no other edits were made.
For CY 2016, 114 qualified registries and 69 QCDRs were qualified to report quality measures data to CMS for purposes of the PQRS, an increase from 98 qualified registries and 49 QCDRs in CY2015.
We estimate that the self-nomination process for qualifying additional qualified registries or QCDRs to submit on behalf of MIPS eligible clinicians or groups for MIPS will involve approximately 1 hour per qualified registry or QCDR to complete the online self-nomination process.
Please note that the self-nomination statement will occur by submission of an email to CMS, or if technically feasible it will occur via an online form that organizations will use to provide information on their business. We estimate that either of these mechanisms will require the same amount of time for respondents.
In addition to completing a self-nomination statement, qualified registries and QCDRs will need to perform various other functions, such as meet with CMS officials when additional information is needed. In addition, QCDRs must benchmark and calculate their measure results. The time it takes to perform these functions may vary depending on the sophistication of the entity, but we estimate that a qualified registry or QCDR will spend an additional 9 hours performing various other functions related to being a MIPS qualified registry or QCDR.
We estimate that the staff involved in the qualified registry or QCDR self-nomination process will mainly be computer systems analysts or their equivalent, who have an average labor cost of $86.72/hour. Therefore, assuming the total burden hours per qualified registry or QCDR associated with the self-nomination process is 10 hours, the annual burden hours is 1,830 (183 QCDRs or qualified registries × 10 hours). We estimate that the total cost to a qualified registry or QCDR associated with the self-nomination process will be approximately $867.20 ($86.72 per hour × 10 hours per qualified registry). We also estimate that 183 new qualified registries or QCDRs will go through the self-nomination process leading to a total burden of $158,697.60 ($867.20 × 183).
The burden associated with the qualified registry and QCDR submission requirements in MIPS will be the time and effort associated with calculating quality measure results from the data submitted to the qualified registry or QCDR by its participants and submitting these results, the numerator and denominator data on quality measures, the advancing care information performance category, and improvement activities data to CMS on behalf of their participants. We expect that the time needed for a qualified registry to accomplish these tasks will vary along with the number of MIPS eligible clinicians submitting data to the qualified registry or QCDR and the number of applicable measures. However, we believe that qualified registries and QCDRs already perform many of these activities for their participants. We believe the estimate above represents the upper bound of QCDR burden, with the potential for less additional MIPS burden if the QCDR already provides similar data submission services.
Based on the assumptions previously discussed, we provide an estimate of total annual burden hours and total annual cost burden associated with a qualified registry or QCDR self-nominating to be considered “qualified” for the purpose of submitting quality measures results and numerator and denominator data on MIPS eligible clinicians.
With regard to the QCDR and registry self-nomination and data submission, we did not receive any public comments regarding the proposed requirements or burden and are adopting them without change.
Under MIPS, a CMS contractor will conduct the MIPS Data Validation Survey in order to identify and address problems with data handling, data accuracy, and incorrect payments. The survey will be part of a broader MIPS strategy to combine our past program integrity processes, including the data validation process used in PQRS and the auditing process used in the Medicare EHR Incentive Program, into one set of requirements for MIPS eligible clinicians and groups, which we refer to as “data validation and auditing”.
Because the data that will be submitted to CMS by, or on behalf of, MIPS eligible clinicians and will be used to calculate payment adjustments, it is critical that this data be accurate. Additionally, the data will be used to generate performance feedback for MIPS eligible clinicians and groups and, in some cases, will be posted publicly on the CMS Web site. This further supports the need for accurate and complete data. The CMS data validation contractor will conduct surveys of groups, registries, QCDRs, health IT vendors, and MIPS eligible clinicians in support of evaluating the data submitted for MIPS. It will be similar to the PQRS Data Validation Survey, which uses a series of approximately 30 questions, arranged by category, to gather information about data handling practices, training, quality assurance, and the challenges that stakeholders face as part of PQRS participation. Under MIPS, the survey's topics will be expanded beyond validation of quality measures to include improvement activities and potentially advancing care information performance category data.
The MIPS Data Validation Survey for performance period 2017 will be conducted in late 2018 for data reported in early 2018. Because the MIPS verification process is still under development, the precise sample size for respondents has not yet been determined. We anticipate that at most 500 organizations would be contacted for MIPS data verification for
We estimate the total annual burden for the ongoing MIPS data validation survey will be up to 645 hours each performance period (430 responses × 1.5 hours), and the data validation will be conducted at a billing clerk's labor rate of $35.20 per hour for a total burden cost of $22,704 ($35.20/hour × 1.5 hours × 430 responses).
With regard to the MIPS data validation survey, we did not receive any public comments regarding the proposed requirements or burden and are adopting them without change.
Under MIPS, groups of two or more clinicians can elect to contract with a CMS-approved survey vendor and use the CAHPS for MIPS survey as one of their six required quality measures. Beneficiaries will experience burden under the CAHPS for MIPS Survey.
The usual practice in estimating the burden on public respondents to surveys such as CAHPS is to assume that respondent time is valued, on average, at civilian wage rates. As previously explained, the BLS data show the average hourly wage for civilians in all occupations to be $23.23. Although most Medicare beneficiaries are retired, we believe that their time value is unlikely to depart significantly from prior earnings expense, and have used the average hourly wage to compute the dollar cost estimate for these burden hours.
Under the first performance period of MIPS, we assume that 461 groups will elect to report on the CAHPS for MIPS survey, which is equal to the number of groups reporting via CAHPS for the PQRS in 2014. Table 50 shows the estimated annualized burden for beneficiaries to participate in the CAHPS for MIPS Survey. Based on historical information on the numbers of CAHPS for PQRS survey respondents, we assume that an average of 287 beneficiaries will respond per group. Therefore, the CAHPS for MIPS survey will be administered to approximately 132,307 beneficiaries per year (461 groups × an average of 287 beneficiaries per group responding). The survey contains 81 items and is estimated to require an average administration time of 18.0 minutes in English (at a pace of 4.5 items per minute) and 21.6 minutes in Spanish (assuming 20 percent more words in the Spanish translation), for an average response time of 19.8 minutes or 0.33 hours. These burden and pace estimates are based on CMS's experience with surveys of similar length that were fielded with Medicare beneficiaries. Given that we expect approximately 132,307 respondents per year, the annual total burden hours are estimated to be 43,661 hours (132,307 respondents × .33 burden hours per respondent). The estimated total burden annual burden cost is $1,014,252 (43,661 total burden hours × $23.23 per hour)
With regard to the CAHPS for MIPS Survey, we did not receive any public comments regarding the proposed requirements or burden. We are updating the CAHPS burden estimates to reflect 2015 data, but no further changes were made.
During the transition year, clinicians and groups can submit advancing care information data through qualified registry, QCDR, EHR, CMS Web Interface, and attestation data submission methods. Also, we have streamlined the submission requirements for advancing care information under the MIPS. Compared to the reporting requirements in the 2015 Medicare EHR Incentive Program Final Rule, two objectives and their associated measures (Clinical Decision Support and Computerized Provider Order Entry) will no longer be required for submission purposes. We have also worked to align the advancing care information performance category with other MIPS performance categories, such as submitting eCQMs to the quality category, which will streamline submission requirements and reduce MIPS eligible clinician confusion. In addition, as part of our efforts to align and streamline submission requirements, we are providing a group reporting option (which did not exist under the Medicare EHR Incentive Program). Hence, a MIPS eligible clinician's estimated burden for the advancing care information performance category is lower than the estimated 7 hours per MIPS eligible clinician in the Medicare EHR Incentive Program —Stage 3 PRA (OMB control number 0938-1278) currently under review at OMB. We are requesting that effective
As noted above in section B, billing TINs may report advancing care information performance category data on behalf of MIPS eligible clinicians in MIPS APMs, or, except for participants in the Shared Savings Program, MIPS eligible clinicians in MIPS APMs may report advancing care information performance category data individually. Because billing TINs in APM Entities will be report advancing care information performance category data to fulfill the requirements of submitting to MIPS, we have included MIPS APMs in our burden estimate for the advancing care information performance category. Consistent with the proposed list of APMs that are MIPS APMs in the proposed rule, we assume that three MIPS APMs that do not also qualify as Advanced APMs will operate in the first performance period: Track 1 of the Shared Savings Program, CEC (one-sided risk arrangement), and OCM (one-sided risk arrangement).
Because performance year 2017 will be the first year for clinicians to report the advancing care information performance category data as groups, there is considerable uncertainty about what number of clinicians will report as part of a groups. Given the limitations of historical 2015 EHR Incentive Program data, some of our burden estimate's assumptions are based on 2015 PQRS data. Specifically, we assume that the number of individual clinicians and groups submitting advancing care information data will be the same as the number of individual clinicians and groups submitting data under the 2015 PQRS. Hence, we assume 503,457 clinicians will submit as individuals and 3,880 groups submitting data on behalf of 194,192 clinicians. Further we anticipate that the 433 Shared Savings Program ACOs will submit data at the ACO participant billing TIN level, for a total of 14,384 billing TINS representing 140,341 participants. We anticipate that the APM Entity in the CEC model one-sided risk arrangement (at the time of publication, there is only one APM Entity in this track) will submit data at the billing TIN level, for an estimated total of 33 billing TINs submitting data. Finally, we anticipate that the 195 APM Entities in the OCM one-sided risk arrangement will submit at the billing TIN level, for an estimated 6,478 billing TINs submitting data. Hence, as shown in Table 51, we estimate that up to approximately 528,231 respondents will be submitting data under the advancing care information performance category (503,457 MIPS eligible clinicians + 3,880 groups submitting on behalf of clinicians + 14,384 billing TINs within the Shared Savings Program ACOs + 33 billing TINs within the APM Entity participating in CEC one-sided risk arrangement and 6,578 billing TINs within the OCM one-sided risk arrangement). The total burden hours for a clinician or group to report on the specified Advancing Care Information Objectives and Measures will be 3 hours. The total estimated burden hours are 1,584,694 (528,231 responses × 3 hours). At a clinician's hourly rate, the total burden cost is $304,476,511 (1,584,694 hours × $194.66/hour).
The following is summary of the comments we received regarding our burden estimate for the advancing care information performance category.
In summary, we have modified our advancing care information data submission requirements in response to public comment, and reduced the corresponding burden estimates as compared to the proposal. In response to public comments, we have also adjusted our estimates to more accurately reflect the burden due to group reporting. Further, the burden estimates have been revised to reflect changes advancing care information data submission requirements for APM Entities under the APM scoring standard between the proposal and final rule, and changed to incorporate updated data on wages, PQRS, and counts of ACOs and their participants.
Requirements for submitting improvement activities are new, and we do not have historical data which is directly relevant. As noted in section II.E.F of this final rule with comment period, a variety of organizations and in some cases, individual clinicians, will report improvement activity performance category data. For clinicians who are not part of APMs, we assume that the number of clinicians submitting improvement activities as part of a group will be approximately the same as the number of clinicians submitting PQRS data as part of a group through the QCDR and registry, EHR, and GPRO Web Interface submission mechanisms in 2015. As noted above, MIPS eligible clinicians participating in MIPS APMs do not need to report improvement activities data unless the CMS-assigned improvement activities score is below the maximum improvement activities score. We estimate that that there could be as many as 503,547 clinicians submitting improvement activities performance category data as individuals, which is equal to the number of clinicians submitting as individuals using the claims, QCDR or qualified registry, or EHR submission mechanisms under the 2015 PQRS.
During the transition year, clinicians and groups can submit data via qualified registry, QCDR, EHR, CMS Web Interface, or attestation data submission mechanisms. In addition to collecting necessary supporting documentation, each clinician and group, will provide a yes/no attestation submitted during the data submission period for successfully completed improvement activities. We estimate that up to approximately 507,457 groups or individuals (3,880 groups and + 503,337 individual clinicians) will be submitting data for improvement
We received comments regarding the improvement activities submission burden estimates.
We have also simplified the improvement activities data submission requirements for MIPS APM participants. The proposal was to require individual MIPS eligible clinicians participating in MIPS APMs to submit improvement activities data. Under the policies finalized in this final rule with comment period, MIPS APM participants will not be required to submit improvement activities data because CMS will assign the score at the MIPS APM level. As noted above, APM Entities in MIPS APMs may submit improvement activities data if the CMS-assigned improvement activities scores is below the maximum improvement activities score.
In summary, we have simplified the improvement activities submission requirements in response to public comments. We have updated the improvement activities burden estimate to reflect the updated data submission requirement, to reflect 2015 data and to more accurately reflect the proportion of clinicians that will submit data as groups.
The cost performance category relies on administrative claims data. For claims-based submitting, the Medicare Parts A and B claims submission process is used to collect data on resource measures from MIPS eligible clinicians. MIPS eligible clinicians are not asked to provide any documentation by CD or hardcopy. Therefore, under the cost performance category, we do not anticipate any new or additional submission requirements for MIPS eligible clinicians.
In the proposed rule, we discussed the MIPS-related submission requirements for participants in MIPS APMs. Advanced APM Entities may face an additional submission requirement under MIPS related to Partial QP elections. The final rule has changed the timing of when eligible clinicians in Advanced APMs receive notification about their Partial QP status, which reduced the burden estimates. Under the revised policy set forth in this final rule with comment period, Advanced APM participants will be notified about their QP or Partial QP status before the end of the performance period, whereas in the proposed rule, Advanced APM participants would not have been notified of their QP or Partial QP status until after the end of the submission period. If an Advanced APM Entity is notified its eligible clinicians are determined as a group to be Partial QPs, a representative from the Advanced APM Entity will log into the MIPS portal to indicate whether MIPS eligible clinicians determined to be Partial QPs wish to participate in MIPS.
In addition, Affiliated Practitioners participating as gainsharers in the CJR model and assessed individually for purposes of the QP determination may face a data submission requirement for Partial QP elections. Under the proposed rule, we did not discuss the CJR model as potentially contributing to the burden for Partial QP elections. However, CMS has recently proposed changes to the CJR model in the proposed Advancing Care Coordination Through Episode Payment Models rule (81 FR 50794 through 28364) that, if finalized, would allow the CJR model to meet the Advanced APM criteria. Because CMS will assess Affiliated Practitioners in the CJR model individually, Affiliated Practitioners must make a Partial QP election at the individual eligible clinician level if they are determined to be Partial QPs. We also estimate that CJR participants are much more likely to be Partial QPs than participants in other Advanced APMs. We therefore estimate that up to 12,800 individual participants in the CJR model may submit partial QP election data.
We estimate it will take each Advanced APM Entity representative or CJR model participant 15 minutes to make this election, and an additional 15 minutes to register for the MIPS Portal. As noted above, we assume that 12,800 participants in the CJR model and no Advanced APM Entities will make this election. Hence, we assume that 12,800 APM Entities' participants will make this election on the MIPS Portal, for a total burden estimate of 6,400 hours (12,800 participants × 0.5 hours). At a computer systems analyst's hourly labor cost, the total burden cost of these elections is collectively estimated to be $555,008 (6,400 × $86.72/hour).
We did not receive any comments on the Partial QP election burden estimates. As noted above, we are adopting changes in the Partial QP burden estimates that reflect policy changes between the proposed rule and final rule with comment period, and the
The total gross burden estimate includes the total burden of recordkeeping and data submission under MIPS. Table 56 provides an estimate of the total annual burden of MIPS of 10,947,453 hours and a total labor cost of reporting of $1,311,245,806. Some of the information collection burden under MIPS does not represent an additional burden to the public, but replaces information collection burden that existed under two of its predecessor programs, the PQRS and the Medicare EHR Incentive Program. The estimated total existing burden approved for information collections related to PQRS and the Medicare EHR Incentive Program (for EPs) was 11,954,112 hours for a total labor cost of reporting of $1,318,689,857. The net burden estimate reflects only the incremental burden associated with this rule, and excludes the burden of existing recordkeeping and data submission under the PQRS, the Medicare EHR Incentive Program, CAHPS for PQRS, and PQRS Data Validation.
We received one general comment regarding our calculations for the burden of the data submission requirements.
In summary, no changes were made to the rule as a result of general comments on the burden estimates.
We have submitted a copy of this rule's information collection and
To obtain copies of the supporting statement and any related forms for the proposed collections discussed above, please visit CMS's Web site at
We invite public comments on these potential information collection requirements. If you wish to comment, please identify the rule (CMS-5517-FC) and submit your comments to the OMB desk officer via one of the following transmissions: Mail: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: 202-395-5806 OR, Email:
This final rule with comment period is necessary to make payment and policy changes under the PFS and to make statutorily-required changes under the MACRA. The MACRA's enactment consolidated certain aspects of physician quality data submission and performance programs into the new Merit-based Incentive Payment System (MIPS), including using certified EHR technology (section 1848(o) of the Act), the PQRS (sections 1848(k) and (m) of the Act), and the VM (section 1848(p) of the Act). These programs have been developed and most recently implemented by us as the Medicare EHR Incentive Program (80 FR 62761), the PQRS (80 FR 71135), and the VM (80 FR 71273). The MACRA's enactment altered the Medicare EHR Incentive Program such that the existing Medicare payment adjustment for EPs under section 1848(a)(7)(A) of the Act will end in CY 2018. Similarly, the MACRA ends the separate PQRS in CY 2018 and provides for the inclusion of various aspects of PQRS in MIPS, and sunsets the VM, ending it in CY 2018 and establishing certain aspects of the VM as a component of MIPS in CY 2019. Finally, the MACRA introduces incentive payment to eligible clinicians who become Qualifying APM Participants (QPs) through participation in Advanced APMs.
This consolidated program for MIPS eligible clinicians represents a new approach to the delivery of health care in this care setting aimed at reducing burden on Medicare-enrolled eligible clinicians, improving population health, lowering growth in overall health care costs, and providing clear incentives for the provision of the best quality care for Medicare beneficiaries. MIPS provides payment adjustments for MIPS eligible clinicians for providing value-driven health care services to their patients, and APMs offer a variety of opportunities that substantially alter the methods of payment for health care and enable clinicians to make fundamental changes to their day-to-day operations to improve the quality and reduce the cost of health care.
We have examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (February 2, 2013), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 14-04), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). We estimate, as discussed below in this section, that the PFS provisions included in this final rule with comment period will redistribute more than $199 million in budget neutral payments in the initial performance year. In addition, this final rule with comment period will increase government outlays for the exceptional performance payments under MIPS ($500 million), and incentive payments to QPs (approximately $333-$571 million). Therefore, we estimate that this rulemaking is “economically significant” as measured by the $100 million threshold, and hence also a major rule under the Congressional Review Act. Accordingly, we have prepared a RIA that, to the best of our ability, presents the costs and benefits of the rulemaking. The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals, 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 (SBA) 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.
There are over 1 million physicians, other practitioners, and medical suppliers that receive Medicare payment under the PFS. Approximately 95 percent of practitioners, other providers and suppliers are considered to be small entities, based upon the SBA standards. As shown later in this analysis, however, potential losses to MIPS eligible clinicians under the MIPS are a small percentage of their total Medicare Part B PFS revenue—4 percent in the initial payment year—though rising to as high as 9 percent in subsequent years. On average, clinicians' Medicare billings are only about 23 percent of total revenue,
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 are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary certifies, that this final rule with comment period 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 (UMRA) 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 2016, that threshold is approximately $146 million. This final rule with comment period would impose no mandates on state, local, or tribal governments or on the private sector because participation in Medicare is voluntary and because physicians and other clinicians have multiple options as to how they will participate under MIPS and discretion over their performance. Moreover, HHS interprets UMRA as applying only to “unfunded” mandates. We do not interpret Medicare payment rules as being “unfunded mandates,” but simply as conditions for the receipt of payments from the federal government for providing services that meet federal standards. This interpretation applies whether the facilities or providers are private, state, local, or tribal.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. Since this regulation does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable.
We have prepared the following analysis, which together with the information provided in the rest of this final rule with comment period, meets all assessment requirements. The analysis explains the rationale for and purposes of this final rule with comment period; details the costs and benefits of the rule; analyzes alternatives; and presents the measures we would use to minimize the burden on small entities. As indicated elsewhere in this final rule with comment period, we are implementing a variety of changes to our regulations, payments, or payment policies to implement statutory provisions. We provide information for each of the policy changes in the relevant sections of this final rule with comment period. We are unaware of any relevant federal rules that duplicate, overlap, or conflict with this final rule with comment period. The relevant sections of this final rule with comment period contain a description of significant alternatives if applicable.
Section 101 of the MACRA, (1) repeals the SGR formula for physician payment updates in Medicare, and (2) requires that we establish MIPS for eligible clinicians under which the Secretary must use a MIPS eligible clinician's final score to determine and apply a MIPS payment adjustment factor to the clinician for a year.
Repealing the SGR formula eliminated significant and immediate problems with Medicare's annual PFS payment updates, including implausible payment reductions (such as the 21.2 percent decrease that was scheduled for April 1, 2015). The Office of the Actuary estimated that avoiding those payment reductions results in a budgetary cost of $150.5 billion for fiscal years 2015 through 2025 compared to the prior law baseline. However, that cost is partially offset by other MACRA provisions that are estimated to have a net reduction in federal expenditures of $47.7 billion, bringing the net cost of the legislation to $102.8 billion.
As required by the MACRA, overall payment rates for services for which payment is made under the PFS would remain at the 2019 level through 2025, but starting in 2019, the amounts paid to individual MIPS eligible clinicians and other eligible clinicians would be subject to adjustment through one of two mechanisms, depending on whether the MIPS eligible clinician or other eligible clinician meets the threshold for participation in Advanced APMs to be considered a Qualifying APM Participant (QP) or Partial QP, or is instead evaluated under MIPS.
For APMs, from 2019 through 2024, eligible clinicians receiving a substantial portion of their revenue through Advanced APMs and meeting other applicable requirements to become QPs would receive a lump-sum APM Incentive Payment equal to 5 percent of their estimated aggregate payment amounts for Medicare covered professional services in the preceding year. The APM Incentive Payment is separate from, and in addition to, the payment for services furnished by an eligible clinician during that year. Eligible clinicians who become QPs would not receive a MIPS payment adjustment under the PFS. Eligible clinicians who do not become QPs, but meet a slightly lower threshold, would be deemed Partial QPs for that year, and may elect to report to and be scored under MIPS but do not receive the APM Incentive Payment. In the 2017 QP Performance Period, we define Partial QPs to be eligible clinicians in Advanced APMs who have at least 20 percent, but less than 25 percent, of their payments for Part B covered professional services through an
Beginning in 2026, payment rates for clinicians who achieve QP status for a year would be increased each year by 0.75 percent, while payment rates for clinicians who do not achieve QP status would be increased each year by 0.25 percent. In addition, MIPS eligible clinicians would receive positive, neutral, or negative MIPS payment adjustments to their Part B payments in a payment year based on performance during a prior performance period. Although the legislation establishes overall payment rate and procedure parameters until 2026 and beyond, this impact analysis covers only the initial payment year (2019) in detail. After 2019, while overall payment levels will be partially bounded, we have also acknowledged in the preamble that the Department will likely revise its quality and other payment measures and overall payment thresholds and other parameters as clinicians' behavior changes.
As discussed further in this final rule with comment period, we are finalizing requirements for MIPS that may result in the exclusion of certain clinicians for various reasons. For example, the MACRA requires us to restrict eligibility for the 2019 and 2020 MIPS payment year to selected clinician types as described in section II.E.1 of this final rule with comment period. Additionally, we are excluding eligible clinicians that do not exceed the low volume threshold as defined in section II.E.3 of this rule: Those with $30,000 or less in Part B allowed charges or 100 or fewer Medicare patients as measured at the TIN/NPI level for individual reporting, the TIN level for group reporting, and the APM Entity level for reporting under the APM scoring standard. We also exclude those who are newly enrolled to Medicare and those eligible clinicians who are QPs.
We projected the number of clinicians that would be excluded from MIPS due to their being QPs using several sources of information. First, the projections are anchored in the most recently available public information on Advanced APMs. The projections reflect APMs operating in 2017 that we indicated in the proposed rule would be Advanced APMs under proposed policies, including the Next Generation ACO Model, Comprehensive Primary Care (CPC) Plus, Comprehensive ESRD Care (CEC) Model, and the Shared Savings Program Tracks 2 and 3. We also factored in information about potential new Advanced APM opportunities including the Advanced APM criteria finalized in § 414.1415 of this final rule with comment period and the updates to the CJR model that were proposed in the Advancing Care Coordination Through Episode Payment Models proposed rule (81 FR 50794 through 28364). We also projected Advanced APM participation based on applicant counts and estimated acceptance rates to Advanced APMs that had open application periods as of September 2016. Finally, we used historical data to examine the extent to which Advanced APM participants would meet the QP thresholds of having at least 25 percent of their Part B covered professional services or at least 20 percent of their Medicare beneficiaries furnished Part B covered professional services through the Advanced APM Entity. We followed the methodologies for group determination of QP status outlined in section II.F.5 of this final rule with comment period, and we determined that all participants in the Advanced APMs that were in operation in 2014 and 2015 would have met the QP thresholds. Based on that information, we assumed that during the first QP Performance Period, the vast majority of eligible clinicians participating in Advanced APM would be QPs.
Using those procedures, we estimated that between approximately 70,000 and 120,000 clinicians would become QPs in the transition year with total Part B allowed charges of approximately $6,666 to $11,428 million. We estimated that the total incentive payment of 5 percent of Part B allowed charges would be between approximately $333 and $571 million. In this regard, it is longstanding HHS policy not to attempt to predict the effects of future rulemakings in order to maximize future Secretarial discretion over whether, and if so how, payment or other rules would be changed.
To estimate the number of clinicians that are not in MIPS due to their clinician type not being eligible, or exclusions due to the low-volume or newly-enrolled eligible clinicians, we began with a list of the clinicians participating in Medicare Part B in 2015.
We estimated the number of excluded clinicians by identifying and counting the clinicians on this list who in 2015 (a) exceeded the low-volume threshold; or (b) were assumed to be newly enrolled in Medicare by virtue of having PFS charges in 2015 but not 2014. We have estimated the effects of these various exclusions in Table 57. More than half (53-57 percent) of 1,380,209 Medicare clinicians billing to Part B will be ineligible for or excluded from MIPS. The excluded or ineligible clinicians represent approximately one-fourth (22-27 percent) of allowed Medicare Part B charges.
According to National Health Expenditure data,
We have estimated the number of clinicians that we believe will be excluded from MIPS in CY 2017 by specialty. Our estimates follow in Table 58. The estimates in Table 58 are based on clinicians in eligible specialties that were excluded because they were newly enrolled, QPs, or met the proposed low-volume exclusion. However, due to data limitations, the estimates in Table 58 include only a portion of the 70,000-120,000 QPs that are listed in Table 57.
Among eligible clinicians, Table 58 shows that the percent excluded from MIPS varies widely across specialties, ranging from a low of 16.8 percent in gastroenterology to a high of 90.2 percent for chiropractors.
We have also estimated the numbers of eligible clinicians that will be excluded from MIPS in CY 2017 by practice size as shown in Table 59. Eligible clinicians in small practices are much more likely to be excluded from MIPS than those in larger practices. For example, more than half (51.6 percent) of eligible clinicians in practices of 1-9 clinicians will be excluded from MIPS, whereas about one-fourth (27.3 percent) of eligible clinicians in practices of 100 or more clinicians will be excluded.
Based on the estimates of excluded clinicians in Table 57, we estimate that between approximately 592,119 and 642,119 eligible clinicians will be required to submit MIPS data to CMS in year 1.
Payment impacts in this final rule with comment period reflect averages by specialty and practice size based on Medicare utilization. The payment impact for a MIPS eligible clinician could vary from the average and would depend on the mix of services that the MIPS eligible clinician furnishes. The average percentage change in total revenues would be less than the impact displayed here because MIPS eligible clinicians generally furnish services to both Medicare and non-Medicare patients. In addition, MIPS eligible clinicians may receive substantial Medicare revenues for services under other Medicare payment systems that would not be affected by MIPS payment adjustment factors.
In order to estimate the impact of MIPS on clinicians required to report, we used the most recently available data, including data from 2015 PQRS, NPPES data and other available data to model the scoring provisions described in this regulation. First, we arithmetically calculated a hypothetical final score for each MIPS eligible clinician based on quality performance. Because the cost performance category has a zero percent weight for the initial payment year, we did not include any cost measures in the final score. Because of the lack of historical data for the advancing care information and improvement activities measures, the model does not estimate scores for the advancing care information and improvement activities performance categories either.
Then, we implemented an exchange function based on the provisions of this final rule with comment period to translate the hypothetical final score into a negative MIPS payment adjustment or positive MIPS payment adjustment. This entailed modifying parameters of the exchange function iteratively in order to achieve distributions in MIPS payment adjustments that meet requirements related to budget neutrality and aggregate exceptional performance payment amounts using a 3 point performance threshold and a 70 point additional performance threshold.
Given the wide diversity of clinical practices, the initial development period of the Quality Payment Program implementation was designed to allow physicians to pick their pace of participation for the first performance period that begins January 1, 2017. Eligible clinicians will have three flexible options to submit data to MIPS and a fourth option to join Advanced APMs in order to become QPs, all of which would ensure they do not receive a negative payment adjustment in 2019. With the extensive changes to policy and flexibility, estimating impacts of this final rule with comment period using only historic 2015 quality submission data significantly overestimates the impact on clinicians, particularly on clinicians in practices with 1-9 clinicians, which have traditionally had lower participation rates. In order to assess the sensitivity of the impact to the participation rate, we have prepared two sets of analyses.
The first analysis, which we label as “standard participation assumptions,” relies on the assumption that policy goals are designed to encourage a minimum 90 percent of MIPS eligible clinicians to participate, regardless of practice size. Therefore, we assumed that, on average, the categories of practices with 1-9 clinicians and practices with 10-24 clinicians would have 90 percent participation. This assumption is an increase from existing historical data. PQRS participation rates have increased steadily since the program began; the 2014 PQRS experience report showed an increase in the participation rate from 15 percent in 2007 to 62 percent in 2014.
The second analysis, which we label as “alternative participation assumptions,” assumes a minimum participation rate of 80 percent. Because the 2015 PQRS participation rates for practices of more than 10 clinicians are greater than 80 percent, this analysis assumes increased participation for practices of 1-9 clinicians. Practices of more than 10 clinicians are included in the model at their historic participation rates.
Table 60 summarizes the impact on Part B services of MIPS eligible clinicians by specialty for the standard participation assumptions. Table 61 summarizes the impact on Part B services of MIPS eligible clinicians by specialty under the alternative participation assumptions.
Tables 62 and 63 summarize the impact on Part B services of MIPS eligible clinicians by practice size for the standard participation assumptions (Table 62) and the alternative participation assumptions (Table 63).
Tables 60 and 62 show that under our standard participation assumptions, the vast majority (94.7percent) of MIPS eligible clinicians are anticipated to receive positive or neutral payment adjustments for the 2019 MIPS payment year, with only 5.3 percent receiving negative MIPS payment adjustments. Using the alternative participation assumptions, Table 63 shows that 91.9 percent of MIPS eligible clinicians are expected to receive positive or neutral payment adjustments. Due to limitations of modeling the new payment policies using historic data, it is not possible to differentiate between positive and neutral adjustment expectations. However, in both the standard and alternative assumptions, participating practices of all sizes are expected to experience a neutral or small net
The distribution of funds reflects this final rule with comment period's emphasis on increasing participation of MIPS eligible clinicians for the transition year of MIPS, which creates a ramp to more robust participation in future MIPS performance years.
The following policy changes were made between the proposed and final rule with comment period to support that emphasis: modifying the low-volume threshold to exclude more clinicians, modifying the performance threshold to 3 for the initial payment year, and adding a performance floor on quality measure benchmarks.
We received several comments about the data used in the RIA.
In summary, in response to comments, the RIA was updated with more recent data where feasible.
As noted earlier, our impact does not include either the advancing care information or the improvement activities performance categories. The proposed rule discussed preliminary data on potential advancing care information scores (81 FR 28370). While we estimate the final score using only the quality performance category score, we recognize the final scores for the 2019 MIPS payment year would be estimated using advancing care information and improvement activities data.
The costs for implementation and complying with the advancing care information performance category requirements could potentially lead to higher operational expenses for MIPS eligible clinicians. However, we believe that the combination of MIPS payment adjustments and long-term overall gains in efficiency will likely offset the initial expenditures. Because section II.E.5.g of this final rule with comment period establishes a policy to reweight the advancing care information performance category scores for MIPS eligible clinicians that were exempt from the Medicare EHR Incentive Program or received hardship exemptions (see 81 FR 28232), the final rule with comment period would not impose additional requirements for EHR adoption during the transition year. Health IT vendors may face additional costs in the transition year of MIPS if they choose to develop additional capabilities in their systems in order to submit advancing care information and improvement activities performance category data on behalf of MIPS eligible clinicians.
Additionally, we believe a majority of MIPS eligible clinicians who are able to report the advancing care information performance category of MIPS have already adopted an EHR during Stage 1 and 2 of the prior Medicare EHR Incentive Program. As we have stated with respect to the Medicare EHR Incentive Program, we believe that future retrospective studies on the costs to implement an EHR and the return on investment (ROI) will demonstrate efficiency improvements that offset the actual costs incurred by MIPS eligible clinicians participating in MIPS and specifically in the advancing care information performance category, but we are unable to quantify those costs and benefits at this time.
At present, evidence on EHR benefits in either improving quality of care or reducing health care costs is mixed. This is not surprising since the adoption of EHR as a fully functioning part of medical practice is progressing, with numerous areas of adoption, use, and sophistication demonstrating need for improvement. Even physicians and hospitals that can meet Medicare EHR Incentive Program standards have not necessarily fully implemented all the functionality of their systems or fully exploited the diagnostic, prescribing, and coordination of care capabilities that these systems promise. Moreover, many of the most important benefits of EHR depend on interoperability among systems and this functionality is still lacking in many EHR systems. A recent RAND report prepared for the ONC reviewed 236 recent studies that related the use of health IT to quality, safety, and efficacy in ambulatory and non-ambulatory care settings and found that—
A majority of studies that evaluated the effects of health IT on healthcare quality, safety, and efficiency reported findings that were at least partially positive. These studies evaluated several forms of health IT: metrics of satisfaction, care process, and cost and health outcomes across many different care settings . . . Our findings agree with previous [research] suggesting that health IT, particularly those functionalities included in the Medicare EHR Incentive Program regulation, can improve healthcare quality and safety. The relationship between health IT and [health care] efficiency is complex and remains poorly documented or understood, particularly in terms of healthcare costs, which are highly dependent upon the care delivery and financial context in which the technology is implemented.
Other recent studies have not found definitive quantitative evidence of benefits.
Similarly, the costs for implementation and complying with the improvement activities performance category requirements could potentially lead to higher expenses for MIPS eligible clinicians. Costs per full-time equivalent primary care clinician for improvement activities will vary across practices, including for some activities or certified patient-centered medical home practices, in incremental costs per encounter, and in estimated costs per member per month. Costs may vary based on panel size and location of practice among other variables. For example, Magill (2015), conducted a study of certified patient-centered medical home practices in two states.
There are a number of changes in this final rule with comment period that would have an effect on beneficiaries. In general, we believe that the changes will have a positive impact and improve the
More broadly, we expect that over time clinician engagement in the Quality Payment Program will increasingly result in improved quality of care, resulting in lower morbidity and mortality, and in reduced spending, as physicians respond to the incentives offered by MIPS and APMs and adjust their clinical practices in order to maximize their performance on specified quality measures and activities. The various shared savings initiatives already operating have demonstrated that all three outcomes are possible. For example, in August of 2015, we issued 2014 quality and financial performance results showing that Medicare ACOs continue to improve the quality of care for Medicare beneficiaries while generating net savings to the Medicare trust fund as well as shared savings to some model participants.
Results from the first year of the CPC Initiative indicate that it has generated nearly enough savings in Medicare health care expenditures to offset care management fees paid by CMS. The primary sources of the savings were reduced rates of hospital admissions and ED visits. The bulk of the savings was generated by patients in the highest-risk quartile, but favorable results were also seen in other patients. Over 90 percent of practices successfully met all first-year transformation requirements. The expenditure impact estimates differ across the seven regions. Additional time and data are needed to assess impact on care quality. The results from the first year of the CPC Initiative should be interpreted cautiously as effects are emerging earlier than anticipated, and additional research is needed to assess how the initiative affects cost and quality of care beyond the first year. Because the effects of the CPC Initiative are likely to be larger in subsequent years, these early results suggest it is likely the model will eventually break even or generate savings.
Basing payment in part on performance metrics is still an evolving art and, as discussed throughout this preamble, there are multiple variables and as yet no definitive answers as to what combinations of measures, benchmarks, and other variables will achieve the best results over time. Accordingly, we are unable at this time to provide specific dollar estimates of these benefits and cost reductions.
The MIPS is aimed at Medicare FFS physicians and other clinicians paid under the PFS. These physicians and other clinicians are almost all engaged in serving patients covered by other payers as well. Because Medicare covers only about one in seven persons (though a considerably higher share of total healthcare spending, since older persons incur far higher expenses on average than younger persons), for most of those services that will be subject to MIPS payment adjustments, Medicare provides only a fraction of practice revenues. Moreover, it is unlikely that many insurance payers will adopt MIPS or MIPS-like payment models in the short run. Hence, MIPS incentives are necessarily attenuated. On the other hand, changing practices for one group of patients will possibly lead to changes for other patients (for example, EHR systems are almost always used for all patients served by a physician). Physicians and other clinicians may find it simpler and more efficient to adopt clinical practice improvements for all patients, regardless of payer, in response to the Quality Payment Program's incentives, through the use of both MIPS measures and activities and APMs. Furthermore, since the Quality Payment Program eventually rewards participation in APMs based on services furnished to patients beyond those in Medicare, other payers may start to develop more models in which clinicians and patients can participate. Hence, there are likely to be beneficial effects on a far broader range of patients in the health care system than simply Medicare patients, and we believe those effects would include improved health care quality and lower costs over time. However, we have no basis at this time for quantifying such effects.
We note that large proportions of the Medicare and Medicaid programs are already delivered through capitated insurance payments to HMOs, PPOs, and related organizations. The Medicare Advantage Plans and related State programs therefore already have substantial incentives to improve quality and reduce costs. MIPS does not affect provider payments under those programs directly, which have their own reimbursement mechanisms for physicians and other clinicians. In many but not all cases, those insurance carriers do use incentive mechanisms that are similar in purpose and design to the kinds of APMs that we expect will arise under the new payment adjustments. We would not expect major near-term changes in HMO and PPO payment arrangements, or performance, from any MIPS or APM spillover effects. Regardless, we have no basis at this time for quantifying any such effects.
There are other potentially affected provider entities, including hospitals, skilled nursing facilities, CAHs (largely small rural hospitals), and providers serving unique populations, such as providers of tribal health care services. In none of these cases do we believe that MIPS would have significant effects on substantial numbers of providers. But to the extent that MIPS and increasing participation in APMs over time succeed in improving quality and reducing costs, there may be some beneficial effects not only on patients but also on some providers.
As noted previously in this section of the final rule with comment period, and as discussed in this subsection, we have concluded that financial effects on either directly or indirectly affected small entities, including rural hospitals, will be minimal. We welcomed comments on these conclusions.
The following is summary of the comments we received regarding the financial effects on either directly or indirectly affected small entities, including rural hospitals.
We will consider whether we should adopt any policies aimed specifically at IHS and other tribal providers in the future.
We understand commenters' concerns about the costs of purchasing and implementing EHR systems in order to participate in MIPS. In response to public comments, we have further simplified the advancing care information reporting requirement and modified the low-volume threshold to exclude more small and solo clinicians with few encounters and low Medicare allowed costs.
In summary, we received many comments about the potential impacts of the rule on small, solo, or rural clinicians. In response to many comments, we modified the low-volume threshold to increase the number of small, solo, and rural clinicians exempt from MIPS requirements. Further, as a result of comments, we have decided to finalize policies throughout the rule, which will focus the Quality Payment Program in its transition year on encouraging participation and educating clinicians while minimizing the risks for negative MIPS payment adjustment. The transition year policies will create a ramp to more robust participation in future years. The policy changes are reflected in the RIA estimates, which show that the risk for negative MIPS payment adjustment is minimal for MIPS eligible clinicians, including small and solo practices that participate.
This final rule with comment period contains a range of policies, including many provisions related to specific statutory provisions. The preceding preamble provides descriptions of the statutory provisions that are addressed, identifies those policies where discretion has been exercised, presents our rationale for our finalized policies and, where relevant, analyzes alternatives that we considered. Although it is hard to single out any one alternative for public comment, the proposed rule particularly called attention to and requested comments on the performance threshold and the level at which it is set for scoring purposes under MIPS.
As described previously, under section 1848(q)(6)(D)(i) of the Act, for each year of MIPS, the Secretary shall
Depending on where the threshold is set within those parameters, the proportions and distributions of MIPS eligible clinicians receiving payment reductions versus positive payment adjustments can change dramatically from our estimates. For example, in Table 60, we estimated (based on available data) that 3.7 percent of Colon/Rectal Surgery specialists will receive a negative payment adjustment under MIPS. Setting the performance threshold at a lower level would enable more Colon/Rectal Surgery specialists to avoid negative MIPS payment adjustments and potentially qualify for more positive MIPS payment adjustments. Conversely, we estimated above that 96.7 percent of Interventional Radiology specialists would receive a positive MIPS payment adjustment under the current proposal. Setting the performance threshold at a higher level would result in fewer Interventional Radiology specialists qualifying for positive MIPS payment adjustments, and potentially more of them receiving negative MIPS payment adjustments. But any payment changes resulting from changes to the performance threshold policy will depend primarily on changes to practices and other responses from MIPS eligible clinicians.
The proposed rule requested comment on these alternatives, on all previous estimates of effects, and on any other issues or options that might improve the substantive effects of the proposed rule, or our estimates of those effects. We were particularly interested in comments on any aspects of the proposed rule that might inadvertently or unintentionally create adverse effects on the delivery of high quality and high value health care, and on options that might reduce such effects.
Comments on the alternatives to the proposed performance threshold are discussed in section II.E.7.c. of this final rule with comment period.
We would like to note several limitations to the analyses that estimated MIPS eligible clinicians' eligibility, negative MIPS payment adjustments, and positive payment adjustments based for the first MIPS performance period (2017) based primarily on 2015 data described above:
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There are additional limitations to our estimates. To the extent that there are year-to-year changes in the data submission, volume and mix of services provided by MIPS eligible clinicians, the actual impact on total Medicare revenues will be different from those shown in Tables 60-63. Due the limitations above, there is considerable uncertainty around our estimates that is difficult to quantify in detail.
As required by OMB Circular A-4 (available at
We have not attempted to quantify the benefits of this rule because of the many uncertainties as to both clinician behaviors and resulting effects on patient health and cost reductions. For example, the applicable percentage for MIPS incentives changes over time, increasing from 4 percent in 2019 to 9 percent in 2022 and subsequent years, and we are unable to estimate precisely how physicians will respond to the increasing incentives. As noted above, in CY 2019, we estimate that we will distribute approximately $199 million in payment adjustments on a budget-neutral basis, which represents the applicable percent for 2019 required under section 1848(q)(6)(B)(i) of the Act and excludes $500 million in exceptional performance payments. In 2020, section 1848(q)(6)(B)(ii) of the Act specifies that the applicable percent will be 5 percent, which we estimate would mean that we will distribute approximately $249 million in payment adjustments on a budget-neutral basis, ignoring changes in clinical practice, volume growth, inflation, or other changes that may affect Medicare physician payments, effects of changes in data submission practices, advancing care information scores, and innovation activities scores, as well as the $500 million in exceptional performance payments. Finally, in 2021, section 1848(q)(6)(B)(iii) of the Act specifies that the applicable percent will be 7 percent, which we estimate would mean that we will distribute approximately $435 million in payment adjustments on a budget-neutral basis, again ignoring changes in clinical practice, volume growth, inflation or other changes that may affect Medicare physician payments, as well as the $500 million in exceptional performance payments.
Further, the addition of new Advanced APMs and growth in Advanced APM participation over time will affect the pool of MIPS eligible clinicians, and for those that are MIPS eligible clinicians, may change their relative performance. The $500 million
The percentage of the final score attributable to each performance category will change over time, and we will incorporate improvement scoring in future years. The Improvement activities category represents an entirely new category for measuring MIPS eligible clinicians' performance. We may also propose policy changes in future years as we continue implementing MIPS and as MIPS eligible clinicians accumulate experience with the new system. Moreover, there are interactions between the MIPS and APM incentive programs and other shared savings and incentive programs that we cannot model or project. Nonetheless, even if ultimate savings and health benefits represent only low fractions of current experience, benefits are likely to be substantial in overall magnitude.
Table 64 includes our estimate for MIPS payment adjustments ($199 million), the exceptional performance payments under MIPS ($500 million), and incentive payments to QPs (using the range described in the preceding analysis, approximately $333-$571 million). However, of these three elements, only the negative MIPS payment adjustments are shown as estimated
We received three comments in response to the estimated federal costs of implementing the rule in Table 64.
Based on National Health Expenditure data,
In summary, after considering comments on government costs, no changes were made to the accounting table.
Administrative practice and procedure, Biologics, Drugs, Health facilities, Health professions, Kidney diseases, Medicare, Reporting and recordkeeping requirements.
Administrative practice and procedure, Health facilities, Health maintenance organizations (HMO), Health professions, Health records, Medicaid, Medicare, Penalties, 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. 1102, 1871, and 1881(b)(l) of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)).
(a)
(1) Section 1833(z)—Incentive Payments for Participation in Eligible Alternative Payment Models.
(2) Section 1848(a)—Payment for Physicians' Services Based on Fee Schedule.
(3) Section 1848(k)—Quality Reporting System.
(4) Section 1848(q)—Merit-based Incentive Payment System.
(b)
(1) The circumstances under which eligible clinicians are not considered MIPS eligible clinicians with respect to a year.
(2) How individual MIPS eligible clinicians can have their performance assessed as a group.
(3) The data submission methods and data submission criteria for each of the MIPS performance categories.
(4) Methods for calculating a performance category score for each of the MIPS performance categories.
(5) Methods for calculating a MIPS final score and applying the MIPS payment adjustment to MIPS eligible clinicians.
(6) Requirements for an APM to be designated an “Advanced APM.”
(7) Methods for eligible clinicians and entities participating in Advanced APMs to meet the participation thresholds to become Qualifying APM Participants (QPs) and Partial QPs.
(8) Methods and processes for counting participation in Other Payer Advanced APMs in making QP and Partial QP determinations.
(9) Methods for calculating and paying the APM Incentive Payment to QPs.
(10) Criteria for Physician-Focused Payment Models (PFPMs).
As used in this section, unless otherwise indicated—
(1) A model under section 1115A of the Act (other than a health care innovation award).
(2) The shared savings program under section 1899 of the Act.
(3) A demonstration under section 1866C of the Act.
(4) A demonstration required by Federal law.
(1) Is not enrolled in Medicare Advantage or a Medicare cost plan;
(2) Does not have Medicare as a secondary payer;
(3) Is enrolled in both Medicare Parts A and B;
(4) Is at least 18 years of age;
(5) Is a United States resident; and
(6) Has a minimum of one claim for evaluation and management services
(1) For any calendar year before 2018, EHR technology (which could include multiple technologies) certified under the ONC Health IT Certification Program that meets one of the following:
(i) The 2014 Edition Base EHR definition (as defined at 45 CFR 170.102) and that has been certified to the certification criteria that are necessary to report on applicable objectives and measures specified for the MIPS advancing care information performance category, including the applicable measure calculation certification criterion at 45 CFR 170.314(g)(1) or (2) for all certification criteria that support an objective with a percentage-based measure.
(ii) Certification to—
(A) The following certification criteria:
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(B) Clinical quality measures at—
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(C) Privacy and security at—
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(D) The certification criteria that are necessary to report on applicable objectives and measures specified for the MIPS advancing care information performance category, including the applicable measure calculation certification criterion at 45 CFR 170.314(g)(1) or (2) or 45 CFR 170.315(g)(1) or (2) for all certification criteria that support an objective with a percentage-based measure.
(iii) The definition for 2018 and subsequent years specified in paragraph (2) of this definition.
(2) For 2018 and subsequent years, EHR technology (which could include multiple technologies) certified under the ONC Health IT Certification Program that meets the 2015 Edition Base EHR definition (as defined at 45 CFR 170.102) and has been certified to the 2015 Edition health IT certification criteria—
(i) At 45 CFR 170.315(a)(12) (family health history) and 45 CFR 170.315(e)(3) (patient health information capture); and
(ii) Necessary to report on applicable objectives and measures specified for the MIPS advancing care information performance category including the following:
(A) The applicable measure calculation certification criterion at 45 CFR 170.315(g)(1) or (2) for all certification criteria that support an objective with a percentage-based measure.
(B) Clinical quality measure certification criteria that support the calculation and reporting of clinical quality measures at 45 CFR 170.315(c)(2) and (c)(3)(i) and (ii) and optionally (c)(4), and can be electronically accepted by CMS.
(1) A physician.
(2) A practitioner described in section 1842(b)(18)(C) of the Act.
(3) A physical or occupational therapist or a qualified speech-language pathologist.
(4) A qualified audiologist (as defined in section 1861(ll)(3)(B) of the Act).
(1) The APM has a primary care focus with participants that primarily include primary care practices or multispecialty practices that include primary care physicians and practitioners and offer primary care services. For the purposes of this provision, primary care focus means the inclusion of specific design elements related to eligible clinicians practicing under one or more of the following Physician Specialty Codes: 01 General Practice; 08 Family Medicine; 11 Internal Medicine; 16 Obstetrics and Gynecology; 37 Pediatric Medicine; 38 Geriatric Medicine; 50 Nurse Practitioner; 89 Clinical Nurse Specialist; and 97 Physician Assistant;
(2) Empanelment of each patient to a primary clinician; and
(3) At least four of the following:
(i) Planned coordination of chronic and preventive care.
(ii) Patient access and continuity of care.
(iii) Risk-stratified care management.
(iv) Coordination of care across the medical neighborhood.
(v) Patient and caregiver engagement.
(vi) Shared decision-making.
(vii) Payment arrangements in addition to, or substituting for, fee-for-service payments (for example, shared savings or population-based payments).
(1) The payment arrangement has a primary care focus with participants that primarily include primary care practices or multispecialty practices that include primary care physicians and practitioners and offer primary care services. For the purposes of this provision, primary care focus means the inclusion of specific design elements related to eligible clinicians practicing under one or more of the following Physician Specialty Codes: 01 General Practice; 08 Family Medicine; 11 Internal Medicine; 16 Obstetrics and Gynecology; 37 Pediatric Medicine; 38 Geriatric Medicine; 50 Nurse Practitioner; 89 Clinical Nurse Specialist; and 97 Physician Assistant;
(2) Empanelment of each patient to a primary clinician; and
(3) At least four of the following:
(i) Planned coordination of chronic and preventive care.
(ii) Patient access and continuity.
(iii) Risk-stratified care management.
(iv) Coordination of care across the medical neighborhood.
(v) Patient and caregiver engagement.
(vi) Shared decision-making.
(vii) Payment arrangements in addition to, or substituting for, fee-for-service payments (for example, shared savings or population-based payments).
(1) A physician as defined in section 1861(r) of the Act.
(2) A physician assistant, a nurse practitioner, and clinical nurse specialist as such terms are defined in section 1861(aa)(5) of the Act.
(3) A certified registered nurse anesthetist as defined in section 1861(bb)(2) of the Act.
(4) A group that includes such clinicians.
(a)
(b)
(i) Is a Qualifying APM Participant (as defined at § 414.1305);
(ii) Is a Partial Qualifying APM Participant (as defined at § 414.1305) and does not report on applicable measures and activities that are required to be reported under MIPS for any given performance period in a year; or
(iii) For the performance period with respect to a year, does not exceed the low-volume threshold as defined at § 414.1305.
(2) Eligible clinicians, as defined at § 414.1305, who are not MIPS eligible clinicians, as defined at § 414.1305, have the option to voluntarily report measures and activities for MIPS.
(c)
(d)
(e)
(i) As part of a single TIN associated with two or more eligible clinicians (including at least one MIPS eligible clinician), as identified by a NPI, that
(ii) [Reserved]
(2) A group must meet the definition of a group at all times during the performance period for the MIPS payment year in order to have its performance assessed as a group.
(3) Eligible clinicians and MIPS eligible clinicians within a group must aggregate their performance data across the TIN in order for their performance to be assessed as a group.
(4) A group that elects to have its performance assessed as a group will be assessed as a group across all four MIPS performance categories.
(5) A group must adhere to an election process established and required by CMS.
(a) For purposes of the 2019 MIPS payment year, the performance period for all performance categories and submission mechanisms except for the cost performance category and data for the quality performance category reported through the CMS Web Interface, for the CAHPS for MIPS survey, and for the all-cause hospital readmission measure, is a minimum of a continuous 90-day period within CY 2017, up to and including the full CY 2017 (January 1, 2017 through December 31, 2017). For purposes of the 2019 MIPS payment year, for data reported through the CMS Web Interface or the CAHPS for MIPS survey and administrative claims-based cost and quality measures, the performance period under MIPS is CY 2017 (January 1, 2017 through December 31, 2017).
(b) For purposes of the 2020 MIPS payment year, the performance period for:
(1) The quality and cost performance categories is CY 2018 (January 1, 2018 through December 31, 2018).
(2) The advancing care information and improvement activities performance categories is a minimum of a continuous 90-day period within CY 2018, up to and including the full CY 2018 (January 1, 2018 through December 31, 2018).
(a)
(b)
(1) A qualified registry for the quality, improvement activities, or advancing care information performance categories;
(2) The EHR submission mechanism (which includes submission of data by health IT vendors or other authorized providers on behalf of MIPS eligible clinicians) for the quality, improvement activities, or advancing care information performance categories;
(3) A QCDR for the quality, improvement activities, or advancing care information performance categories;
(4) Medicare Part B claims for the quality performance category; or
(5) Attestation for the improvement activities and advancing care information performance categories.
(c)
(1) A qualified registry for the quality, improvement activities, or advancing care information performance categories;
(2) The EHR submission mechanism (which includes the submission of data by health IT vendors on behalf of groups) for the quality, improvement activities, or advancing care information performance categories;
(3) A QCDR for the quality, improvement activities, or advancing care information performance categories;
(4) A CMS Web Interface (for groups comprised of at least 25 MIPS eligible clinicians) for the quality, improvement activities, and advancing care information performance categories;
(5) Attestation for the improvement activities and advancing care information performance categories; or
(6) A CMS-approved survey vendor for groups that elect to include the CAHPS for MIPS survey as a quality measure. Groups that elect to include the CAHPS for MIPS survey as a quality measure must select one of the above data submission mechanisms to submit their other quality information.
(d)
(e)
(f)
(1) For the qualified registry, QCDR, EHR, and attestation submission mechanisms are March 31 following the close of the performance period.
(2) For Medicare Part B claims, data must be submitted on claims with dates of service during the performance period that must be processed no later than 60 days following the close of the performance period.
(3) For the CMS Web Interface, data must be submitted during an 8-week period following the close of the performance period. The period must begin no earlier than January 2 and end no later than March 31.
(a) For purposes of assessing performance of MIPS eligible clinicians on the quality performance category, CMS will use:
(1) Quality measures included in the MIPS final list of quality measures.
(2) Quality measures used by QCDRs.
(b) Subject to CMS's authority to reweight performance category weights under section 1848(q)(5)(F) of the Act, performance in the quality performance category will comprise:
(1) 60 percent of a MIPS eligible clinician's final score for MIPS payment year 2019.
(2) 50 percent of a MIPS eligible clinician's final score for MIPS payment year 2020.
(3) 30 percent of a MIPS eligible clinician's final score for each MIPS payment year thereafter.
(a)
(1)
(i) Submit data on at least six measures including at least one outcome measure. If an applicable outcome measure is not available, report one other high priority measure (appropriate use, patient safety, efficiency, patient experience, and care coordination measures). If fewer than six measures apply to the MIPS eligible clinician or
(ii) Subject to paragraph (a)(1)(i) of this section, MIPS eligible clinicians and groups can either select their measures from the complete MIPS final measure list or a subset of that list, MIPS specialty-specific measure sets, as designated by CMS.
(2)
(i) For a group of 25 or more MIPS eligible clinicians, report on all measures included in the CMS Web Interface. The group must report on the first 248 consecutively ranked beneficiaries in the sample for each measure or module.
(ii) If the sample of eligible assigned beneficiaries is less than 248, then the group must report on 100 percent of assigned beneficiaries. In some instances, the sampling methodology will not be able to assign at least 248 patients on which a group may report, particularly those groups on the smaller end of the range of 25-99 MIPS eligible clinicians.
(iii) The group is required to report on at least one measure for which there is Medicare patient data.
(iv) Groups reporting via the CMS Web Interface are required to report on all of the measures in the set.
(3)
(A) The CAHPS for MIPS survey counts for one measure towards the MIPS quality performance category and, as a patient experience measure, also fulfills the requirement to report at least one high priority measure in the absence of an applicable outcome measure.
(B) Groups that elect this data submission mechanism must select an additional group data submission mechanism in order to meet the data submission criteria for the MIPS quality performance category.
(ii) [Reserved]
(b) [Reserved]
(a) MIPS eligible clinicians and groups submitting quality measures data using the QCDR, qualified registry, or EHR submission mechanism must submit data on:
(1) At least 50 percent of the MIPS eligible clinician or group's patients that meet the measure's denominator criteria, regardless of payer for MIPS payment year 2019.
(2) At least 60 percent of the MIPS eligible clinician or group's patients that meet the measure's denominator criteria, regardless of payer for MIPS payment year 2020.
(b) MIPS eligible clinicians submitting quality measures data using Medicare Part B claims, must submit data on:
(1) At least 50 percent of the applicable Medicare Part B patients seen during the performance period to which the measure applies for MIPS payment year 2019.
(2) At least 60 percent of the applicable Medicare Part B patients seen during the performance period to which the measure applies for MIPS payment year 2020.
(c) Groups submitting quality measures data using the CMS Web Interface or a CMS-approved survey vendor to submit the CAHPS for MIPS survey must meet the data submission requirement on the sample of the Medicare Part B patients CMS provides.
(a) For purposes of assessing performance of MIPS eligible clinicians on the cost performance category, CMS specifies cost measures for a performance period.
(b) Subject to CMS's authority to reweight performance category weights under section 1848(q)(5)(F) of the Act, performance in the cost performance category comprises:
(1) 0 percent of a MIPS eligible clinician's final score for MIPS payment year 2019.
(2) 10 percent of a MIPS eligible clinician's final score for MIPS payment year 2020.
(3) 30 percent of a MIPS eligible clinician's final score for each MIPS payment year thereafter.
(a) For purposes of assessing performance of MIPS eligible clinicians on the improvement activities performance category, CMS specifies an inventory of measures and activities for a performance period.
(b) Subject to CMS's authority to reweight performance category weights under section 1848(q)(5)(F) of the Act, performance in the improvement activities performance category comprises:
(1) 15 percent of a MIPS eligible clinician's final score for MIPS payment year 2019 and for each MIPS payment year thereafter.
(2) [Reserved].
(c) For purposes of assessing performance of MIPS eligible clinicians on the improvement activities performance category, CMS uses activities included in the improvement activities inventory established by CMS through rulemaking.
(a) MIPS eligible clinicians must submit data on MIPS improvement activities in one of the following manners:
(1) Via qualified registry, EHR submission mechanisms, QCDR, CMS Web Interface or Attestation. For activities that are performed for at least a continuous 90-days during the performance period, MIPS eligible clinicians must—
(i) Submit a yes response for activities within the improvement activities inventory.
(ii) [Reserved]
(2) [Reserved]
(b) [Reserved]
(a) The following are the list of subcategories, of which, with the exception of Participation in an APM, include activities for selection by a MIPS eligible clinician or group:
(1) Expanded practice access, such as same day appointments for urgent needs and after-hours access to clinician advice.
(2) Population management, such as monitoring health conditions of individuals to provide timely health care interventions or participation in a QCDR.
(3) Care coordination, such as timely communication of test results, timely exchange of clinical information to patients or other clinicians, and use of remote monitoring or telehealth.
(4) Beneficiary engagement, such as the establishment of care plans for individuals with complex care needs, beneficiary self-management assessment and training, and using shared decision-making mechanisms.
(5) Patient safety and practice assessment, such as through the use of clinical or surgical checklists and practice assessments related to maintaining certification.
(6) Participation in an APM.
(7) Achieving health equity, such as for MIPS eligible clinicians that achieve high quality for underserved populations, including persons with behavioral health conditions, racial and
(8) Emergency preparedness and response, such as measuring MIPS eligible clinician participation in the Medical Reserve Corps, measuring registration in the Emergency System for Advance Registration of Volunteer Health Professionals, measuring relevant reserve and active duty uniformed services MIPS eligible clinician activities, and measuring MIPS eligible clinician volunteer participation in domestic or international humanitarian medical relief work.
(9) Integrated behavioral and mental health, such as measuring or evaluating such practices as: Co-location of behavioral health and primary care services; shared/integrated behavioral health and primary care records; cross-training of MIPS eligible clinicians, and integrating behavioral health with primary care to address substance use disorders or other behavioral health conditions, as well as integrating mental health with primary care.
(b) [Reserved]
(a)
(b)
(1) APM Entities participate in the APM under an agreement with CMS or through a law or regulation;
(2) The APM is designed such that APM Entities participating in the APM include at least one MIPS eligible clinician on a Participation List;
(3) The APM bases payment on cost/utilization and quality measures; and
(4) The APM is not either of the following:
(i)
(ii)
(c)
(d)
(1) APM identifier (established for the APM by CMS);
(2) APM Entity identifier (established for the APM Entity by CMS);
(3) Medicare-enrolled billing TIN; and
(4) Eligible clinician NPI.
(e)
(f)
(g)
(ii) [Reserved]
(2)
(3)
(ii) [Reserved]
(4)
(ii) For APM Entity groups in MIPS APMs other than the Shared Savings Program, CMS uses one score for each MIPS eligible clinician in the APM Entity group to derive a single average APM Entity group score for advancing care information. The score for each MIPS eligible clinician is the higher of either:
(A) A group score based on the measure data for the advancing care information performance category reported by a TIN for the MIPS eligible clinician according to the MIPS submission and reporting requirements for groups; or
(B) An individual score based on the measure data for the advancing care information performance category reported by the MIPS eligible clinician according to the MIPS submission and reporting requirements for individuals.
(h)
(1)
(ii) For 2017, for MIPS APMs that do not require APM Entities to submit quality data through the CMS Web Interface: 0 percent.
(2)
(3)
(ii) For 2017, for MIPS APMs that do not require APM Entities to submit quality data through the CMS Web Interface: 25 percent.
(4)
(ii) For 2017, for MIPS APMs that do not require APM Entities to submit quality data through the CMS Web Interface: 75 percent.
(a)
(b)
(1)
(2)
(i) Report the numerator (of at least one) and denominator, or yes/no statement as applicable, for each required measure; or
(ii) Report a null value for each required measure that includes a null value as an acceptable result in the measure specification.
(3)
(A) Must attest that he or she:
(
(
(B) Optionally, may also attest that he or she:
(
(
(ii)
(A) Did not knowingly and willfully take action (such as to disable functionality) to limit or restrict the compatibility or interoperability of certified EHR technology.
(B) Implemented technologies, standards, policies, practices, and agreements reasonably calculated to ensure, to the greatest extent practicable and permitted by law, that the certified EHR technology was, at all relevant times—
(
(
(
(
(C) Responded in good faith and in a timely manner to requests to retrieve or exchange electronic health information, including from patients, health care providers (as defined by 42 U.S.C. 300jj(3)), and other persons, regardless of the requestor's affiliation or technology vendor.
(a)
(1) Measures and activities in the four performance categories are scored against performance standards.
(i) For the quality performance category, measures are scored between zero and 10 points. Performance is measured against benchmarks. Bonus points are available for both submitting specific types of measures and submitting measures using end-to-end electronic reporting.
(ii) For the cost performance category, measures are scored between one and 10 points. Performance is measured against a benchmark.
(iii) For the improvement activities performance category, each improvement activity is worth a certain number of points. The points for each reported activity are summed and scored against a total potential performance category score of 40 points.
(iv) For the advancing care information performance category, the performance category score is the sum of a base score, performance score, and bonus score.
(2) [Reserved]
(b)
(1)
(i) Measure benchmarks are based on historical performance for the measure based on a baseline period. Each benchmark must have a minimum of 20 individual clinicians or groups who reported the measure meeting the data completeness requirement and minimum case size criteria and performance greater than zero. We will restrict the benchmarks to data from MIPS eligible clinicians and comparable APM data, including data from QPs and Partial QPs.
(ii) As an exception, if there is no comparable data from the baseline period, CMS would use information from the performance period to create measure benchmarks, which would not be published until after the performance period. For the 2017 performance period, CMS would use information from CY 2017 during which MIPS eligible clinicians may report for a minimum of any continuous 90-day period.
(A) CMS Web Interface submission uses benchmarks from the corresponding reporting year of the Shared Savings Program.
(B) [Reserved]
(iii) Separate benchmarks are used for the following submission mechanisms:
(A) EHR submission options;
(B) QCDR and qualified registry submission options;
(C) Claims submission options;
(D) CMS Web Interface submission options;
(E) CMS-approved survey vendor for CAHPS for MIPS submission options; and
(F) Administrative claims submission options.
(iv) Minimum case requirements for quality measures are 20 cases, unless a measure is subject to an exception.
(v) As an exception, the minimum case requirements for the all-cause hospital readmission measure is 200 cases.
(vi) MIPS eligible clinicians failing to report a measure required under this category receive zero points for that measure.
(vii) MIPS eligible clinicians do not receive zero points if the expected measure is submitted but is unable to be scored because it does not meet the required case minimum or if the measure does not have a measure benchmark for MIPS payment year 2019. Instead, these measures as well as measures that are below the data completeness requirement receive a score of 3 points in MIPS payment year 2019.
(viii) As an exception, the administrative claims-based measures and CMS Web Interface measures will not be scored if these measures do not meet the required case minimum. For CMS Web Interface measures, we will recognize the measure was submitted but exclude the measure from being scored. For CMS Web Interface measures: measures that do not have a measure benchmark will also not be scored, although we will recognize that the measure was submitted, and measures that are below the data completeness requirement receive 0 points.
(ix) Measures submitted by MIPS eligible clinicians are scored using a percentile distribution, separated by decile categories.
(x) For each set of benchmarks, CMS calculates the decile breaks for measure performance and assigns points based on which benchmark decile range the MIPS eligible clinician's measure rate is between.
(xi) CMS assigns partial points based on the percentile distribution.
(xii) MIPS eligible clinicians are required to submit measures consistent with § 414.1335.
(xiii) Bonus points are available for measures determined to be high priority measures when two or more high priority measures are reported.
(A) Bonus points are not available for the first reported high priority measure which is required to be reported. To qualify for bonus points, each measure must be reported with sufficient case volume to the meet the required case minimum and the required data completeness criteria and does not have a zero percent performance rate, regardless of whether it is included in the calculation of the quality performance category score.
(B) Outcome and patient experience measures receive two bonus points.
(C) Other high priority measures receive one bonus point.
(D) Bonus points for high priority measures cannot exceed 10 percent of the total possible points for MIPS payment year 2019 and 2020.
(xiv) One bonus point is also available for each measure submitted with end-to-end electronic reporting for a quality measure under certain criteria determined by the Secretary. Bonus points cannot exceed 10 percent of the total possible points for MIPS payment year 2019 and 2020.
(xv) A MIPS eligible clinician's quality performance category score is the sum of all the points assigned for the measures required for the quality performance category criteria plus the bonus points in paragraph (b)(1)(xiii) of this section and bonus points in paragraph (b)(1)(xiv) of this section. The sum is divided by the sum of total possible points. The quality performance category score cannot exceed the total possible points for the quality performance category.
(2)
(i) Cost measure benchmarks are based on the performance period. Cost measures must have a benchmark to be scored.
(ii) A MIPS eligible clinician must meet the minimum case volume specified by CMS to be scored on a cost measure.
(iii) A MIPS eligible clinician's cost performance category score is the equally-weighted average of all scored cost measures.
(3)
(i) CMS assigns credit for the total possible category score for each reported improvement activity based on two weights: Medium-weighted; and high-weighted activities.
(ii) Improvement activities with a high weighting receive credit for 20 points, toward the total possible category score.
(iii) Improvement activities with a medium weighting receive credit for
10 points toward the total possible category score.
(iv) A MIPS eligible clinician or group in a practice that is certified as a patient-centered medical home or comparable specialty practice, as determined by the Secretary, receives full credit for performance on the improvement activities performance category. For purposes of this paragraph (b)(3)(iv), “full credit” means that the MIPS eligible clinician or group has met the highest potential score of 40 points. A practice is certified as a patient-centered medical home if it meets any of the following criteria:
(A) The practice has received accreditation from one of four accreditation organizations that are nationally recognized;
(
(
(
(
(B) The practice is participating in a Medicaid Medical Home Model or Medical Home Model.
(C) The practice is a comparable specialty practice that has received the NCQA Patient-Centered Specialty Recognition.
(D) The practice has received accreditation from other certifying bodies that have certified a large
(
(
(
(
(
(v) CMS compares the points associated with the reported activities against the highest potential category score of 40 points.
(vi) A MIPS eligible clinician or group's improvement activities category score is the sum of points for all of their reported activities, which is capped at 40 points, divided by the highest potential category score of 40 points.
(vii) Non-patient facing MIPS eligible clinicians and groups, small practices, and practices located in rural areas and geographic HPSAs receive full credit for improvement activities by selecting one high-weighted improvement activity or two medium-weighted improvement activities. Non-patient facing MIPS eligible clinicians and groups, small practices, and practices located in rural areas and geographic HPSAs receive half credit for improvement activities by selecting one medium-weighted improvement activity.
(viii) To receive full credit as a certified patient-centered medical home or comparable specialty practice requires that a TIN that is reporting includes at least one practice which is a certified patient-centered medical home or comparable specialty practice.
(ix) MIPS eligible clinicians participating in APMs that are not patient-centered medical homes for a performance period shall earn a minimum score of one-half of the highest potential score for the improvement activities performance category.
(4)
(A) A MIPS eligible clinician earns a base score by reporting the numerator (of at least one) and denominator or yes/no statement or null value as applicable, for each required measure
(B) A MIPS eligible clinician earns a performance score by reporting on certain measures specified by CMS. MIPS eligible clinicians may earn up to 10 or 20 percentage points as specified by CMS for each measure reported for the performance score.
(C) A MIPS eligible clinician earn a bonus of five percentage points for reporting any measures beyond than the Immunization Registry Reporting measure for the Public Health and Clinical Data Registry objective.
(D) A MIPS eligible clinician earns a bonus of 10 percentage points for attesting to completing one or more improvement activities specified by CMS using CEHRT.
(ii) [Reserved]
(c)
(1)
(i) Quality performance category weight is defined under § 414.1330(b).
(ii) Cost performance category weight is defined under § 414.1350(b).
(iii) Improvement activities performance category weight is defined under § 414.1355(b).
(iv) Advancing care information performance category weight is defined under § 414.1375(a).
(2)
(d)
(a)
(1) MIPS eligible clinicians and groups have a 60-day period to submit a request for targeted review, which begins on the day CMS makes available the MIPS payment adjustment factor, and if applicable the additional MIPS payment adjustment factor, for the MIPS payment year and ends on September 30 of the year prior to the MIPS payment year or a later date specified by CMS.
(2) CMS will respond to each request for targeted review timely submitted and determine whether a targeted review is warranted.
(3) The MIPS eligible clinician or group may include additional information in support of their request for targeted review at the time the request is submitted. If CMS requests additional information from the MIPS eligible clinician or group, it must be provided and received by CMS within 30 days of the request. Non-responsiveness to the request for additional information may result in the closure of the targeted review request, although the MIPS eligible clinician or group may submit another request for targeted review before the deadline.
(4) Decisions based on the targeted review are final, and there is no further review or appeal.
(b)
(1) The methodology used to determine the amount of the MIPS payment adjustment factor and the amount of the additional MIPS payment adjustment factor and the determination of such amounts;
(2) The establishment of the performance standards and the performance period;
(3) The identification of measures and activities specified for a MIPS performance category and information made public or posted on the Physician Compare Internet Web site of the CMS; and
(4) The methodology developed that is used to calculate performance scores and the calculation of such scores, including the weighting of measures and activities under such methodology.
(a)
(1) Comply with data sharing requests, providing all data as requested
(2) Provide substantive, primary source documents as requested. These documents may include: Copies of claims, medical records for applicable patients, or other resources used in the data calculations for MIPS measures, objectives, and activities. Primary source documentation also may include verification of records for Medicare and non-Medicare beneficiaries where applicable.
(b) [Reserved]
(a)
(b) [Reserved]
(a)
(i) A qualified registry;
(ii) A QCDR;
(iii) A health IT vendor or other authorized third party that obtains data from a MIPS eligible clinician's CEHRT; or
(iv) A CMS-approved survey vendor.
(2) Qualified registries, QCDRs, and health IT vendors or other authorized third parties may submit data on measures, activities, or objectives for any of the following MIPS performance categories:
(i) Quality;
(ii) Improvement activities; or
(iii) Advancing care information, if the MIPS eligible clinician or group is using CEHRT.
(3) CMS-approved survey vendors may submit data for the CAHPS for MIPS survey under the MIPS quality performance category.
(4) Third party intermediaries must meet all the criteria specified by CMS to qualify and be approved as a third party intermediary for purposes of MIPS, including, but not limited to, the following criteria:
(i) For measures, activities, and objectives under the quality, advancing care information, and improvement activities performance categories, if the data is derived from CEHRT, the QCDR, qualified registry, or health IT vendor must be able to indicate its data source.
(ii) All submitted data must be submitted in the form and manner specified by CMS.
(b)
(c)
(1) Be in existence as of January 1 of the performance period for which the entity seeks to become a QCDR.
(2) Have at least 25 participants by January 1 of the performance period.
(d)
(1) An entity that uses an external organization for purposes of data collection, calculation, or transmission may meet the definition of a QCDR as long as the entity has a signed, written agreement that specifically details the relationship and responsibilities of the entity with the external organization effective as of September 1 the year prior to the year for which the entity seeks to become a QCDR.
(2) [Reserved]
(e)
(1) A measure that is not contained in the annual list of MIPS quality measures for the applicable performance period.
(2) A measure that may be in the annual list of MIPS quality measures but has substantive differences, as determined by the Secretary, in the manner it is reported by the QCDR.
(3) CAHPS for MIPS survey. Although the CAHPS for MIPS survey included in the MIPS measure set, we consider the changes that need to be made for reporting by individual MIPS eligible clinicians (and not as a part of a group) significant enough as to treat the CAHPS for MIPS survey as a non-MIPS quality measure for purposes of individual MIPS eligible clinicians reporting the CAHPS for MIPS survey via a QCDR.
(f)
(1) For non-MIPS quality measures, the quality measure specifications must include the following for each measure: Name/title of measures, NQF number (if NQF-endorsed), descriptions of the denominator, numerator, and when applicable, denominator exceptions, denominator exclusions, risk adjustment variables, and risk adjustment algorithms. The narrative specifications provided must be similar to the narrative specifications we provide in our measures list. CMS will consider all non-MIPS quality measures submitted by the QCDR but the measures must address a gap in care and outcome or other high priority measures are preferred. Documentation or “check box” measures are discouraged. Measures that have very high performance rates already or address extremely rare gaps in care (thereby allowing for little or no quality distinction between eligible clinicians) are also unlikely to be approved for inclusion.
(2) For MIPS quality measures, the QCDR only needs to submit the MIPS measure numbers or specialty-specific measure sets (if applicable).
(3) The QCDR must publicly post the measure specifications (no later than 15 days following CMS approval of the measure specifications) for each non-MIPS quality measure it intends to submit for MIPS. The QCDR may use any public format it prefers. Immediately following posting of the measures specification, the QCDR must
(g)
(h)
(1) Be in existence as of January 1 of the performance period for which the entity seeks to become a qualified registry.
(2) Have at least 25 participants by January 1 of the performance period.
(i)
(j)
(1) The entity must make available to CMS the contact information of each MIPS eligible clinician or group on behalf of whom it submits data. The contact information will include, at a minimum, the MIPS eligible clinician or group's practice phone number, address, and, if available, email.
(2) The entity must retain all data submitted to CMS for MIPS for a minimum of 10 years.
(3) For the purposes of auditing, CMS may request any records or data retained for the purposes of MIPS for up to 6 years and 3 months.
(k)
(2) For purposes of this section, probation means that, for the applicable performance period, the third party intermediary must meet all applicable criteria for qualification and approval and must submit a corrective action plan for remediation or correction of any deficiencies identified by CMS that resulted in the probation.
(3) CMS requires a corrective action plan from the third party intermediary to address any deficiencies or issues and prevent them from recurring. The corrective action plan must be received and accepted by CMS within 14 days of the CMS notification to the third party intermediary of the deficiency or probation. If the corrective action plan is not received and accepted by CMS within the specified time, CMS may disqualify the third party intermediary from the MIPS program for the subsequent performance period.
(4) If the third party intermediary has data inaccuracies including (but not limited to) TIN/NPI mismatches, formatting issues, calculation errors, data audit discrepancies affecting in excess of 3 percent (but less than 5 percent) of the total number of MIPS eligible clinicians or groups submitted by the third party intermediary, such inaccuracies will trigger paragraph (k)(3) of this section and may result in this information being posted on the CMS Web site.
(5) If the third party intermediary does not reduce their data error rate below 3 percent for the subsequent performance period, the third party intermediary will continue to be on probation and have their listing on the CMS Web site continue to note the poor quality of the data they are submitting for MIPS for one additional year. After 2 years on probation, the third party intermediary will be disqualified for the subsequent performance period.
(6) Before placing the third party intermediary on probation; CMS would notify the third party intermediary of the identified issues, at the time of discovery of such issues.
(7) If the third party intermediary does not submit an acceptable corrective action plan within 14 days of notification of deficiencies, and correct the deficiencies within 30 days or before the submission deadline—whichever is sooner, CMS may disqualify the third party intermediary from participating in MIPS for the current performance period or the following performance period, as applicable.
(a)
(b)
(1) MIPS eligible clinicians with a final score at or above the performance threshold receive a zero or positive MIPS payment adjustment factor on a linear sliding scale such that an adjustment factor of 0 percent is assigned for a final score at the performance threshold and an adjustment factor of the applicable percent is assigned for a final score of 100.
(2) MIPS eligible clinicians with a final score below the performance threshold receive a negative MIPS payment adjustment factor on a linear sliding scale such that an adjustment factor of 0 percent is assigned for a final score at the performance threshold and an adjustment factor of the negative of the applicable percent is assigned for a final score of 0; further, MIPS eligible clinicians with final scores that are equal to or greater than zero, but not greater than one-fourth of the performance threshold, receive a negative MIPS payment adjustment factor that is equal to the negative of the applicable percent.
(3) A scaling factor not to exceed 3.0 may be applied to positive MIPS payment adjustment factors to ensure budget neutrality such that the estimated increase in aggregate allowed charges resulting from the application of the positive MIPS payment adjustment factors for the MIPS payment year equals the estimated decrease in aggregate allowed charges resulting from the application of negative MIPS payment adjustment factors for the MIPS payment year.
(c)
(d)
(1) In addition to the MIPS payment adjustment factor, MIPS eligible
(2) [Reserved]
(e)
(a)
(b)
(1)
(ii) CMS updates the Advanced APM list on its Web site at intervals no less than annually.
(iii) CMS will include notice of whether a new APM is an Advanced APM in the first public notice of the new APM.
(2)
(ii) CMS makes Other Payer Advanced APM determinations prior to QP determinations under § 414.1440.
(iii) CMS makes final Other Payer Advanced APM determinations and notifies Advanced APM Entities and eligible clinicians of such determinations as soon as practicable.
(a)
(i) Require at least 50 percent of eligible clinicians in each participating APM Entity group, or, for APMs in which hospitals are the APM Entities, each hospital, to use CEHRT to document and communicate clinical care to their patients or other health care providers; or
(ii) For the Shared Savings Program, apply a penalty or reward to an APM Entity based on the degree of the use of CEHRT of the eligible clinicians in the APM Entity.
(b)
(2) At least one of the quality measures upon which an Advanced APM bases the payment in paragraph (b)(1) of this section must have an evidence-based focus, be reliable and valid, and meet at least one of the following criteria:
(i) Used in the MIPS quality performance category as described in § 414.1330;
(ii) Endorsed by a consensus-based entity;
(iii) Developed under section 1848(s) of the Act;
(iv) Submitted in response to the MIPS Call for Quality Measures under section 1848(q)(2)(D)(ii) of the Act; or
(v) Any other quality measures that CMS determines to have an evidence-based focus and to be reliable and valid.
(3) In addition to the quality measure requirements under paragraph (b)(2) of this section, the quality measures upon which an Advanced APM bases the payment in paragraph (b)(1) of this section must include at least one outcome measure. This requirement does not apply if CMS determines that there are no available or applicable outcome measures included in the MIPS quality measures list for the Advanced APM's first QP Performance Period.
(c)
(1)
(i) Withhold payment for services to the APM Entity or the APM Entity's eligible clinicians;
(ii) Reduce payment rates to the APM Entity or the APM Entity's eligible clinicians; or
(iii) Require the APM Entity to owe payment(s) to CMS.
(2)
(i) Withholds payment for services to the APM Entity or the APM Entity's eligible clinicians;
(ii) Reduces payment rates to the APM Entity or the APM Entity's eligible clinicians;
(iii) Requires the APM Entity to owe payment(s) to CMS; or
(iv) Causes the APM Entity to lose the right to all or part of an otherwise guaranteed payment or payments.
(3)
(A) For QP Performance Periods 2017 and 2018, 8 percent of the estimated average total Medicare Parts A and B revenues of participating APM Entities; or
(B) 3 percent of the expected expenditures for which an APM Entity is responsible under the APM.
(ii) [Reserved]
(4)
(A) For QP Performance Period 2017, 2.5 percent of the estimated average
(B) For QP Performance Period 2018, 3 percent of the estimated average total Medicare Parts A and B revenues of participating APM Entities;
(C) For QP Performance Period 2019, 4 percent of the estimated average total Medicare Parts A and B revenues of participating APM Entities.
(D) For QP Performance Period 2020 and later, 5 percent of the estimated average total Medicare Parts A and B revenues of participating APM Entities.
(5)
(6)
(a)
(1) Use of CEHRT, as described in paragraph (b) of this section;
(2) Quality measures comparable to measures under the MIPS quality performance category apply, as described in paragraph (c) of this section; and
(3) Either:
(i) Requires APM Entities to bears more than nominal financial risk if actual aggregate expenditures exceed expected aggregate expenditures, as described in paragraph (d) of this section; or
(ii) Is a Medicaid Medical Home Model that meets criteria comparable to Medical Home Models expanded under section 1115A(c) of the Act, as described in paragraph (d)(3) of this section.
(b)
(c)
(2) At least one of the quality measures used in the payment arrangement with an APM Entity must have an evidence-based focus, be reliable and valid, and meet at least one of the following criteria:
(i) Used in the MIPS quality performance category, as described in § 414.1330;
(ii) Endorsed by a consensus-based entity;
(iii) Developed under section 1848(s) of the Act;
(iv) Submitted in response to the MIPS Call for Quality Measures under section 1848(q)(2)(D)(ii) of the Act; or
(v) Any other quality measures that CMS determines to have an evidence-based focus and to be reliable and valid.
(3) To meet the quality measure use criterion, an other payment arrangement must use an outcome measure if there is an applicable outcome measure on the MIPS quality measure list. If an Other Payer Advanced APM has no outcome measure, the Advanced APM Entity must attest that there is no applicable outcome measure on the MIPS list.
(d)
(1)
(i) Withhold payment for services to the APM Entity or the APM Entity's eligible clinicians;
(ii) Reduce payment rates to the APM Entity or the APM Entity's eligible clinicians; or
(iii) Require direct payment by the APM Entity to the payer.
(2)
(i) Withhold payment for services to the APM Entity or the APM Entity's eligible clinicians;
(ii) Require direct payment by the APM Entity to the Medicaid program;
(iii) Reduce payment rates to the APM Entity or the APM Entity's eligible clinicians; or
(iv) Require the APM Entity to lose the right to all or part of an otherwise guaranteed payment or payments.
(3)
(ii) Except for risk arrangements described under paragraph (d)(2) of this section, the risk arrangement must have:
(A) A marginal risk rate of at least 30 percent; and
(B) Total potential risk of at least 4 percent of expected expenditures.
(4)
(i) For QP Performance Period 2019, 4 percent of the estimated average total revenue of participating APM Entities from the payer.
(ii) For QP Performance Period 2020 and later, 5 percent of the estimated average total revenue of participating APM Entities for the payer.
(5)
(i) In the event that the marginal risk rate varies depending on the amount by which actual expenditures exceed expected expenditures, the lowest marginal risk rate across all possible levels of actual expenditures would be used for comparison to the marginal risk rate specified in paragraph (d)(3)(ii)(A) of this section, with exceptions for large losses as described in paragraph (d)(5)(ii) of this section and small losses as described in paragraph (d)(5)(iii) of this section.
(ii) Allowance for large losses. The determination in paragraph (d)(3)(ii)(A) of this section may disregard the marginal risk rates that apply in cases when actual expenditures exceed expected expenditures by an amount sufficient to require the APM Entity to make financial risk payments under the Other Payer Advanced APM greater than or equal to the total risk requirement under paragraph (d)(3)(i) of this section.
(iii) Allowance for minimum loss rate. The determination in paragraph (d)(3)(ii)(A) of this section may disregard the marginal risk rates that apply in cases when actual expenditures exceed expected expenditures by less than 4 percent of expected expenditures.
(6)
(7)
(a)
(2) For Advanced APMs with Advanced APM Entities that do not include eligible clinicians on a Participation List but do include eligible clinicians on an Affiliated Practitioner List, the Affiliated Practitioner List defines the eligible clinicians who will be assessed to become QPs.
(3) For Advanced APMs with some Advanced APM Entities that include eligible clinicians on a Participation List and other Advanced APM Entities that only include eligible clinicians on an Affiliated Practitioner List, paragraph (a)(1) applies to APM Entities that include eligible clinicians on a Participation List, and paragraph (a)(2) applies to APM Entities that only include eligible clinicians on an Affiliated Practitioner List.
(b)
(2)
(c)
(2) An eligible clinician cannot be both a QP and a Partial QP for a year. A determination that an eligible clinician is a QP means that the eligible clinician is not a Partial QP.
(3) An eligible clinician is a QP for a year if the eligible clinician is in an APM Entity group that achieves a Threshold Score that meets or exceeds the corresponding QP payment amount threshold or QP patient count threshold for that QP Performance Period, as described in § 414.1430(a)(1) and (3) and (b)(1) and (3).
(4) Notwithstanding paragraph (c)(3) of this section, an eligible clinician is a QP for a year if:
(i) The eligible clinician is included in more than one Advanced APM Entity group and none of the Advanced APM Entity groups in which the eligible clinician is included meets the QP payment amount threshold or the QP patient count threshold, or the eligible clinician is an Affiliated Practitioner; and
(ii) CMS determines that the eligible clinician individually achieves a Threshold Score that meets or exceeds the QP payment amount threshold or the QP patient count threshold.
(5) Notwithstanding paragraph (c)(3) of this section, an eligible clinician is not a QP for a year if the APM Entity group voluntarily or involuntarily terminates from an Advanced APM before the end of the QP Performance Period.
(6) Notwithstanding paragraph (c)(4) of this section, an eligible clinician is not a QP for a year if any of the Advanced APM Entities in which the eligible clinician participates voluntarily or involuntarily terminates from the Advanced APM before the end of the QP Performance Period.
(d)
(2) Notwithstanding paragraph (d)(1) of this section, an eligible clinician is a Partial QP for a year if:
(i) The eligible clinician is included in more than one APM Entity group and none of the APM Entity groups in which the eligible clinician is included meets the corresponding QP or Partial QP threshold, or the eligible clinician is an Affiliated Practitioner; and
(ii) CMS determines that the eligible clinician individually achieves a Threshold Score that meets or exceeds the corresponding Partial QP Threshold.
(3) Notwithstanding paragraph (d)(1) of this section, an eligible clinician is not a Partial QP for a year if the APM Entity group voluntarily or involuntarily terminates from an Advanced APM before the end of the QP Performance Period.
(4) Notwithstanding paragraph (d)(2) of this section, an eligible clinician is not a Partial QP for a year if any of the Advanced APM Entities in which the eligible clinician participates voluntarily or involuntarily terminates from the Advanced APM before the end of the QP Performance Period.
(e)
(f)
(2) For payment years 2021 and later, CMS performs QP determinations for eligible clinicians under the Medicare Option, as described in § 414.1435 and, except as specified in paragraphs (d)(2)(i) and (ii) of this section, the All-Payer Combination Option, described in § 414.1440.
(i) If CMS determines the eligible clinician to be a QP under the Medicare Option, then CMS does not calculate a Threshold Score for such eligible clinician under the All-Payer Combination Option.
(ii) If the Threshold Score for an eligible clinician under the Medicare Option is less than the amount specified in § 414.1430(b)(2)(ii) and (b)(3)(iii), then CMS does not perform a QP determination for such eligible clinician(s) under the All-Payer Combination Option.
(a)
(i) 2019 and 2020: 25 percent.
(ii) 2021 and 2022: 50 percent.
(iii) 2023 and later: 75 percent.
(2)
(i) 2019 and 2020: 20 percent.
(ii) 2021 and 2022: 40 percent.
(ii) 2023 and later: 50 percent.
(3)
(i) 2019 and 2020: 20 percent
(ii) 2021 and 2022: 35 percent
(ii) 2023 and later: 50 percent
(4)
(i) 2019 and 2020: 10 percent
(ii) 2021 and 2022: 25 percent
(iii) 2023 and later: 35 percent
(b)
(i) The QP payment amount thresholds are the following values for the indicated payment years:
(A) 2021 and 2022: 50 percent.
(B) 2023 and later: 75 percent.
(ii) To meet the QP payment amount threshold under this option, the eligible clinician must also meet a 25 percent QP payment amount threshold under the Medicare Option.
(2)
(A) 2021 and 2022: 40 percent.
(B) 2023 and later: 50 percent.
(ii) To meet the QP payment amount threshold under this option, the eligible clinician must also meet a 20 percent Partial QP payment amount threshold under the Medicare Option.
(3)
(A) 2021 and 2022: 35 percent.
(B) 2023 and later: 50 percent.
(ii) To meet the QP patient count threshold under this option, the eligible clinician must also meet a 20 percent QP patient count threshold under the Medicare Option.
(4)
(A) 2021 and 2022: 25 percent.
(B) 2023 and later: 35 percent.
(ii) To meet the Partial QP patient count threshold under this option, the eligible clinician group or eligible clinician must also meet a 10 percent QP patient count threshold under the Medicare Option.
(a)
(1)
(2)
(3)
(b)
(1)
(2)
(3)
(4)
(c)
(2) When operationally feasible, this attributed beneficiary list will be the final beneficiary list used for reconciliation purposes in the Advanced APM.
(3) When it is not operationally feasible to use the final attributed beneficiary list, the attributed beneficiary list will be taken from the Advanced APM's most recently available attributed beneficiary list at the end of the QP Performance Period.
(d)
(a)
(i) The Secretary of Defense for the costs of Department of Defense health care programs;
(ii) The Secretary of Veterans Affairs for the cost of Department of Veterans Affairs health care programs; and
(iii) Under Title XIX in a State in which no Medicaid Medical Home Model or APM is available.
(2) Title XIX payments will only be included in the numerator and denominator as specified in paragraphs (b)(2) and (3) of this section for an Advanced APM Entity if:
(i) A State has at least one Medicaid Medical Home Model or Medicaid APM in operation that is determined to be an Other Payer Advanced APM; and
(ii) The Advanced APM Entity is eligible to participate in at least one of such Other Payer Advanced APMs during the QP Performance Period, regardless of whether the Advanced APM Entity actually participates in such Other Payer Advanced APMs. This will apply to both the payment amount and patient count methods.
(b)
(2)
(3)
(c)
(2)
(3)
(d)
(2) CMS may count a single patient in the numerator and/or denominator for multiple different Advanced APM Entities or eligible clinicians.
(3) For purposes of this section, Advanced APM Entities are considered the same entity across Other Payer Advanced APMs if CMS determines that the Participation Lists are substantially similar or if one entity is a subset of the other.
(a)
(b)
(1) Payment arrangement information necessary to assess the other payer arrangement on all Other Payer Advanced APM criteria under § 414.1420;
(2) For each other payment arrangement, the amount of revenues for services furnished through the arrangement, the total revenues from the payer, the numbers of patients furnished any service through the arrangement, and the total numbers of patients furnished any service through the payer.
(3) An attestation from the payer that the submitted information is accurate.
(c)
(i) The eligible clinician's Advanced APM Entity submits the information required under this section for CMS to assess the APM Entity group under the All-Payer Combination Option; or
(ii) The eligible clinician submits adequate information under this section.
(2) If neither the Advanced APM Entity nor the eligible clinician submits all of the information required under this section, then CMS does not make a QP assessment for such eligible clinician under the All-Payer Combination Option.
(d)
(1)
(2) [Reserved]
(a)
(2) CMS provides notice of the amount of the APM Incentive Payment to QPs as soon as practicable following the calculation and validation of the APM Incentive Payment amount, but in any event no later than 1 year after the incentive payment base period.
(b)
(2) The estimated aggregate payment amount for covered professional services includes all such payments to any and all of the TIN/NPI combinations associated with the NPI of the QP.
(3) In calculating the estimated aggregate payment amount for a QP, CMS uses claims submitted with dates of service from January 1 through December 31 of the incentive payment base period, and processing dates of January 1 of the base period through March 31 of the subsequent payment year.
(4) The payment adjustment amounts, negative or positive, as described in sections 1848(m), (o), (p), and (q) of the Act are not included in calculating the APM Incentive Payment amount.
(5) Incentive payments made to eligible clinicians under sections 1833(m), (x), and (y) of the Act are not included in calculating the APM Incentive Payment amount.
(6) Financial risk payments such as shared savings payments or net reconciliation payments are excluded from the amount of covered professional services in calculating the APM Incentive Payment amount.
(7) Supplemental service payments in the amount of covered professional services are included in calculating the APM Incentive Payment amount according to this paragraph (b). Supplemental service payments are included in the amount of covered professional services when calculating the APM Incentive Payment amount when the supplemental service payment meets the following four criteria:
(i) Is payment for services that constitute physicians services authorized under section 1832(a) and defined under section 1861(s) of the Act.
(ii) Is made for only Part B services under the criterion in paragraph (b)(9)(i) of this section.
(iii) Is directly attributable to services furnished to an individual beneficiary.
(iv) Is directly attributable to an eligible clinician, including an eligible clinician that is a group of individual eligible clinicians.
(8) For payment amounts that are affected by a cash flow mechanism, the payment amounts that would have occurred if the cash flow mechanism were not in place are used in calculating the APM Incentive Payment amount.
(c)
(2) In the event that an eligible clinician is no longer affiliated with the TIN associated with the QP's participation in the Advanced APM Entity that met the applicable QP threshold during the QP Performance Period at the time of the APM Incentive Payment distribution, CMS makes the APM Incentive Payment to the TIN listed on the eligible clinician's CMS-588 EFT Application form on the date that the APM Incentive Payment is distributed.
(3) In the event that an eligible clinician becomes a QP through participation in multiple Advanced APMs, CMS divides the APM Incentive Payment amount between the TINs associated with the QP's participation in each Advanced APM during the QP Performance Period. Such payments will be divided in proportion to the amount of payments associated with each TIN that the eligible clinician received for covered professional services during the QP Performance Period.
(d)
(e)
(2) APM Incentive Payments made under this section are not included in calculations for the purposes of rebasing benchmarks in an APM.
(f)
There is no administrative or judicial review under sections 1869, 1878, or otherwise, of the Act of the following:
(a) The determination that an eligible clinician is a QP or Partial QP under § 414.1425 and the determination that an APM Entity is an Advanced APM Entity under § 414.1410.
(b) The determination of the amount of the APM Incentive Payment under § 414.1450, including any estimation as part of such determination.
(a)
(b)
(c)
(d)
(e)
(1) CMS determines there is a special need to retain a particular record or group of records for a longer period and notifies the Advanced APM Entity of eligible clinician at least 30 days before the formal disposition date; or
(2) There has been a termination, dispute, or allegation of fraud or similar fault against the Advanced APM Entity or eligible clinician, in which case the Advanced APM Entity or eligible clinician must retain records for an additional 6 years from the date of any resulting final resolution of the termination, dispute, or allegation of fraud or similar fault.
(f)
(a)
(1) In which Medicare is a payer;
(2) In which eligible clinicians that are eligible professionals as defined in section 1848(k)(3)(B) of the Act are participants and play a core role in implementing the APM's payment methodology; and
(3) Which targets the quality and costs of services that eligible professionals participating in the Alternative Payment Model provide, order, or can significantly influence.
(b)
(1)
(ii) Flexibility: provide the flexibility needed for practitioners to deliver high-quality health care.
(iii) Quality and Cost: are anticipated to improve health care quality at no additional cost, maintain health care quality while decreasing cost, or both improve health care quality and decrease cost.
(iv) Payment methodology: pay APM Entities with a payment methodology designed to achieve the goals of the PFPM Criteria. Addresses in detail through this methodology how Medicare, and other payers if applicable, pay APM Entities, how the payment methodology differs from current payment methodologies, and why the PFPM cannot be tested under current payment methodologies.
(v) Scope: aim to broaden or expand the CMS APM portfolio by addressing an issue in payment policy in a new way or including APM Entities whose opportunities to participate in APMs have been limited.
(vi) Ability to be evaluated: have evaluable goals for quality of care, cost, and any other goals of the PFPM.
(2)
(ii) Patient Choice: encourage greater attention to the health of the population served while also supporting the unique needs and preferences of individual patients.
(iii) Patient Safety: aim to maintain or improve standards of patient safety.
(3)
(ii) [Reserved]
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
(1) Subject to paragraph (3) of this definition, an EP, eligible hospital or CAH that, for an EHR reporting period for a payment year or payment adjustment year, demonstrates in accordance with § 495.40 meaningful use of certified EHR technology by meeting the applicable objectives and associated measures under §§ 495.20, 495.22, and 495.24, supporting information exchange and the prevention of health information blocking and engaging in activities related to supporting providers with the performance of CEHRT, and 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; and
(2)(i) Except as specified in paragraph (2)(ii) of this definition, a Medicaid EP or Medicaid eligible hospital, that meets the requirements of paragraph (1) of this definition and any additional criteria for meaningful use imposed by the State and approved by CMS under §§ 495.316 and 495.332.
(ii) An eligible hospital or CAH is deemed to be a meaningful EHR user for purposes of receiving an incentive payment under subpart D of this part, if the hospital participates in both the Medicare and Medicaid EHR incentive programs, and the hospital meets the
(3) To be considered a meaningful EHR user, at least 50 percent of an EP's patient encounters during an EHR reporting period for a payment year (or, in the case of a payment adjustment year, during an applicable EHR reporting period for such payment adjustment year) must occur at a practice/location or practices/locations equipped with certified EHR technology.
The revisions and additions read as follows:
(a)
(2) * * *
(i) * * *
(E) For CY 2015 and 2016, satisfied the required objectives and associated measures under § 495.22(e) for meaningful use.
(F) For CY 2017, the EP may satisfy either the objectives and measures specified in § 495.22(e), or the objectives and measures specified in § 495.24(d).
(G) For CY 2018 and subsequent years, satisfied the required objectives and associated measures under § 495.24(d) for meaningful use.
(H) Supporting providers with the performance of CEHRT (SPPC). To engage in activities related to supporting providers with the performance of CEHRT, the EP—
(1) Must attest that he or she:
(i) Acknowledges the requirement to cooperate in good faith with ONC direct review of his or her health information technology certified under the ONC Health IT Certification Program if a request to assist in ONC direct review is received; and
(ii) If requested, cooperated in good faith with ONC direct review of his or her health information technology certified under the ONC Health IT Certification Program as authorized by 45 CFR part 170, subpart E, to the extent that such technology meets (or can be used to meet) the definition of CEHRT, including by permitting timely access to such technology and demonstrating its capabilities as implemented and used by the EP in the field.
(2) Optionally, may also attest that he or she:
(i) Acknowledges the option to cooperate in good faith with ONC-ACB surveillance of his or her health information technology certified under the ONC Health IT Certification Program if a request to assist in ONC-ACB surveillance is received; and
(ii) If requested, cooperated in good faith with ONC-ACB surveillance of his or her health information technology certified under the ONC Health IT Certification Program as authorized by 45 CFR part 170, subpart E, to the extent that such technology meets (or can be used to meet) the definition of CEHRT, including by permitting timely access to such technology and demonstrating capabilities as implemented and used by the EP in the field.
(I) Support for health information exchange and the prevention of information blocking. For an EHR reporting period in CY 2017 and subsequent years, the EP must attest that he or she—
(
(
(
(
(
(
(
(b)
(2) * * *
(i) * * *
(H) Supporting providers with the performance of CEHRT (SPPC). To engage in activities related to supporting providers with the performance of CEHRT, the eligible hospital or CAH—
(
(
(
(
(
(
(I) Support for health information exchange and the prevention of information blocking. For an EHR reporting period in CY 2017 and subsequent years, the eligible hospital or CAH must attest that it—
(
(
(
(
(
(
(
(d) * * *
(1) Subject to paragraphs (d)(3) and (4) of this section, for CY 2015 through the end of CY 2018, for covered professional services furnished by an EP who is not hospital-based, and who is not a qualifying EP by virtue of not being a meaningful EHR user (for the EHR reporting period applicable to the payment adjustment year), the payment amount for such services is equal to the product of the applicable percent specified in paragraph (d)(2) of this section and the Medicare physician fee schedule amount for such services.
(2) * * *
(iv) For 2018, 97 percent, except as provided in paragraph (d)(3) of this section.
(3)
(g) * * *
(2) Subject to paragraph (h)(2) of this section, provider-level attestation data for each eligible hospital that attests to demonstrating meaningful use for each payment year beginning with 2013.
(3) Subject to paragraph (h)(2) of this section, provider-level attestation data for each eligible EP that attests to demonstrating meaningful use for each payment year beginning with 2013 and ending after 2016.
The following Appendix will not appear in the Code of Federal Regulations.
NOTE: “TABLE C: Individual Quality Cross-Cutting Measures for the MIPS to Be Available to Meet the Reporting Criteria Via Claims, Registry, and EHR Beginning in 2017” has been removed per policy change—See (add reference) for Rationale]
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule.
This rule updates and makes revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year 2017. It also finalizes policies for coverage and payment for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. This rule also sets forth requirements for the ESRD Quality Incentive Program, including the inclusion of new quality measures beginning with payment year (PY) 2020 and provides updates to programmatic policies for the PY 2018 and PY 2019 ESRD QIP.
This rule also implements statutory requirements for bid surety bonds and state licensure for the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). This rule also expands suppliers' appeal rights in the event of a breach of contract action taken by CMS, by revising the appeals regulation to extend the appeals process to all types of actions taken by CMS for a supplier's breach of contract, rather than limit an appeal for the termination of a competitive bidding contract. The rule also finalizes changes to the methodologies for adjusting fee schedule amounts for DMEPOS using information from CBPs and for submitting bids and establishing single payment amounts under the CBPs for certain groupings of similar items with different features to address price inversions. Final changes also are made to the method for establishing bid limits for items under the DMEPOS CBPs. In addition, this rule summarizes comments on the impacts of coordinating Medicare and Medicaid Durable Medical Equipment for dually eligible beneficiaries. Finally, this rule also summarizes comments received in response to a request for information related to the Comprehensive ESRD Care Model and future payment models affecting renal care.
These regulations are effective January 1, 2017.
Stephanie Frilling, (410) 786-4597, for issues related to the ESRD QIP.
Julia Howard, (410) 786-8645, for issues related to DMEPOS CBP and bid surety bonds, state licensure, and the appeals process for breach of DMEPOS CBP contract actions.
Anita Greenberg, (410) 786-4601, or Hafsa Vahora, (410) 786-7899, for issues related to competitive bidding and payment for similar DMEPOS items with different features and bid limits.
Kristen Zycherman, for issues related to DME access issues.
Tom Duvall, (410) 786-8887 or email
In the past, a majority of the Addenda referred to throughout the preamble of our proposed and final rules were available in the
To assist readers in referencing sections contained in this preamble, we are providing a Table of Contents. Some of the issues discussed in this preamble affect the payment policies, but do not require changes to the regulations in the Code of Federal Regulations (CFR).
Because of the many terms to which we refer by acronym in this final rule, we are listing the acronyms used and their corresponding meanings in alphabetical order below:
On January 1, 2011, we implemented the ESRD PPS, a case-mix adjusted, bundled prospective payment (PPS) system for renal dialysis services furnished by ESRD facilities. This rule updates and makes revisions to the End-Stage Renal Disease (ESRD) (PPS) for calendar year (CY) 2017. Section 1881(b)(14) of the Social Security Act (the Act), as added by section 153(b) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275), and section 1881(b)(14)(F) of the Act, as added by section 153(b) of MIPPA and amended by section 3401(h) of the Affordable Care Act (Pub. L. 111-148), established that beginning CY 2012, and each subsequent year, the Secretary shall annually increase payment amounts by an ESRD market basket increase factor, reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act.
On June 29, 2015, the President signed the Trade Preferences Extension Act of 2015 (TPEA) (Pub. L. 114-27). Section 808(a) of TPEA amended section 1861(s)(2)(F) of the Act to provide coverage for renal dialysis services furnished on or after January 1, 2017, by a renal dialysis facility or a provider of services paid under section 1881(b)(14) to an individual with AKI. Section 808(b) of TPEA amended section 1834 of the Act by adding a new paragraph (r) of the Act that provides for payment for renal dialysis services furnished by renal dialysis facilities or providers of services paid under section 1881(b)(14) to individuals with AKI at the ESRD PPS base rate beginning January 1, 2017.
This rule also sets forth requirements for the ESRD QIP, including for payment years (PYs) 2018, 2019, and 2020. The program is authorized under section 1881(h) of the Social Security Act (the Act). The ESRD QIP is the most recent step in fostering improved patient outcomes by establishing incentives for dialysis facilities to meet or exceed performance standards established by CMS.
This rule implements statutory requirements for Bid Surety Bonds and State Licensure. We are revising the appeals regulation to expand suppliers' appeal rights in the event of a breach of contract determination to allow suppliers to appeal any breach of contract action CMS takes, rather than just a termination action.
This rule adjusts the method for adjusting DMEPOS fee schedule amounts for certain groupings of similar items with different features using information from DMEPOS competitive bidding programs (CBPs), submitting bids and determining single payment amounts for certain groupings of similar items with different features under the DMEPOS CBPs, and establishing bid limits for individual items under the DMEPOS CBP.
•
•
•
•
•
We are implementing the TPEA amendments to sections 1834(r) and 1861(s)(2)(F) by finalizing coverage of renal dialysis services furnished by renal dialysis facilities paid under section 1881(b)(14) of the Act to individuals with AKI. We will pay ESRD facilities for renal dialysis services furnished to individuals with AKI at the amount of the ESRD PPS base rate, as adjusted by the ESRD PPS wage index. In addition, drugs, biologicals, and laboratory services that ESRD facilities are certified to furnish, but that are not renal dialysis services, may be paid for separately when furnished by ESRD facilities to individuals with AKI. In addition, because AKI patients are often under the care of a hospital, physician, or other practitioner, these providers and practitioners may continue to bill Medicare for services in the same manner as they did before the payment rate for renal dialysis services furnished by dialysis facilities to individuals with AKI was adopted.
This rule sets forth requirements for the ESRD QIP for payment years (PYs) 2018, 2019 and 2020.
Specifically, for PY 2019, we are assigning 15 percent of a facility's total performance score (TPS) to the Safety Measure Domain, 75 percent of the TPS to the Clinical Measure Domain and 10 percent to the Reporting Measure Domain. To accommodate the removal of the Safety Subdomain from the Clinical Measure Domain, we are adjusting individual measure weights for the measures that remain in the Clinical Measure Domain. In response to comments received, for PY 2020, we are maintaining the weight of the Safety Measure Domain at 15 percent of a facility's TPS rather than at 10 percent as proposed.
For PY 2019, we are increasing the size of the NHSN BSI Data Validation study. Specifically, we will randomly select 35 facilities to participate in an NHSN dialysis event validation study for two quarters of data reported in CY 2017. A CMS contractor will send these facilities requests for medical records for all patients with “candidate events” during the evaluation period, as well as randomly selected patient records. Each facility selected will be required to submit 10 records total to the validation contractor. The CMS contractor will utilize a methodology for reviewing and validating the candidate events and will analyze those records to determine whether the facility reported dialysis events for those patients in accordance with the NHSN Dialysis Event Protocol. Information from the validation study may be used to develop a methodology to score facilities based on the accuracy of their reporting of the NHSN BSI measure.
This final rule implements statutory requirements for the DMEPOS CBP for bid surety bonds and state licensure. In addition, we are finalizing a definition for the term “bidding entity” for purposes of the DMEPOS CBP. We also are finalizing revisions to the appeals regulations to expand suppliers' appeal
• A bidding entity must obtain a bid surety bond from an authorized surety on the Department of the Treasury's Listing of Certified Companies, submit proof of the surety bond by the deadline for bid submission, and the bond must meet certain specifications. We define the term “bidding entity” to mean the entity whose legal business name is identified in the “Form A: Business Organization Information” section of the bid.
• If the bidding entity is offered a contract for any product category for a competitive acquisition area (herein referred to as a “Competitive Bidding Area” or “CBA”), and its composite bid for such product category and area is at or below the median composite bid rate for all bidding entities included in the calculation of the single payment amounts for the product category/CBA combination (herein also referred to as “competition”), and the entity does not accept the contract offered, the entity's bid surety bond for the applicable CBA will be forfeited and CMS will collect on the bid surety bond via Electronic Funds Transfer from the respective authorized surety. If the forfeiture conditions are not met, the bond liability will be returned to the bidding entity. Bidding entities that provide a falsified bid surety bond will be prohibited from participation in the DMEPOS CBP for the current round of the CBP in which they submitted a bid and also from bidding in the next round of the CBP. Bidding entities that provide a falsified bid surety bond will also be referred to the Office of Inspector General and Department of Justice for further investigation.
• We are conforming the language of our regulation at 42 CFR 414.414(b)(3) to the language of section 1847(b)(2)(A)(v) of the Act, as added by section 522 of MACRA, which requires bidding entities to meet applicable State licensure requirements in order to be eligible for a DMEPOS CBP contract. We note, however, that this does not reflect a change in policy as CMS already has a regulation in place that requires suppliers to meet applicable State licensure requirements.
• We are finalizing changes to § 414.423 to extend the appeals process to all breach of contract actions taken by CMS specified in § 414.422(g)(2). We are finalizing revisions to § 414.422(g)(2) to eliminate certain breach of contract actions. We also are finalizing revisions to § 414.423(l) to describe the effects of certain breach of contract actions that CMS takes.
This final rule sets forth requirements for the CBP and Fee Schedule Adjustments.
• Methodologies for Adjusting DMEPOS Fee Schedule Amounts for Certain Groupings of Similar Items with Different Features using Information from Competitive Bidding Programs: Within the Healthcare Common Procedure Coding System (HCPCS), there are many instances where there are multiple codes for an item that are distinguished by the addition of a feature (for example, non-powered versus powered mattress, Group 1 versus Group 2 power wheelchair, pump without alarm versus pump with alarm, walker without wheels versus walker with wheels, etc.) Under CBPs, the code with the higher utilization (typically the item with additional features and higher fee schedule amounts) receives a higher weight and the bid for this item has a greater impact on the supplier's composite bid than the bids for the less frequently used codes. This is resulting in price inversions where the single payment amounts (SPAs) for the item without the feature are higher than the SPAs for the item with the feature. This could lead to program vulnerability by shifting beneficiaries from products with features to less appropriate products without the features because the product without the features receives higher payment under competitive bidding. We are finalizing provisions of § 414.210 to limit SPAs for certain items without a feature to the weighted average of the SPAs for the items both with and without the feature prior to using the SPAs to adjust the fee schedule amounts for certain groupings of similar items specified below. The item weights will be the same weights used in calculating the composite bids under the CBP.
• Submitting Bids and Determining Single Payment Amounts for Certain Groupings of Similar Items with Different Features under the DMEPOS CBP: This rule addresses the price inversions under competitive bidding to prevent situations where beneficiaries receive items with fewer features at a higher price than items with more features. In addition to affecting the appropriateness of items supplied to beneficiaries, these price inversions also undermine the CBP and diminish the savings intended from implementation of the program. We are finalizing provisions of § 414.412 to add a lead item bidding method where all of the HCPCS codes for similar items with different features will be grouped together and will be priced relative to the bid for the lead item in order to prevent price inversions under the DMEPOS CBPs. We are applying this as an alternative to the current bidding method so that CMS will be able to apply this method to situations where groupings of similar items have resulted in price inversions based on past experience. This alternative method will only replace the current method of bidding for select groupings of similar items within product categories.
• Bid Limits for Individual Items under the DMEPOS CBP: Current regulations require that bids submitted by suppliers under the CBP be lower than the amount that would otherwise apply (that is, the fee schedule amount). This ensures that total payments expected to be made to contract suppliers in a CBA are less than the total amounts that would otherwise be paid, as required by section 1847(b)(2)A)(iii) of the Act for awarding contracts under the program in an area. Beginning in 2016, the fee schedule amounts for DMEPOS items and services are adjusted based on information from the CBPs. We indicated in the final rule (79 FR 66232), which was published in the
In section XV.A of this final rule, we set forth a detailed analysis of the impacts of the finalized changes for affected entities and beneficiaries. The impacts include the following:
The impact chart in section XV.B.1 of this final rule displays the estimated change in payments to ESRD facilities in CY 2017 compared to estimated payments in CY 2016. The overall impact of the CY 2017 changes is projected to be a 0.73 percent increase in payments. Hospital-based ESRD facilities have an estimated 0.9 percent increase in payments compared with freestanding facilities with an estimated 0.7 percent increase.
We estimate that the aggregate ESRD PPS expenditures will increase by approximately $80 million from CY 2016 to CY 2017. This reflects a $60 million increase from the payment rate update and a $20 million increase due to the updates to the outlier threshold amounts. As a result of the projected 0.73 percent overall payment increase, we estimate that there will be an increase in beneficiary co-insurance payments of 4.2 percent in CY 2017, which translates to approximately $10 million.
We anticipate an estimated $2 million being redirected from hospital outpatient departments to ESRD facilities in CY 2017 as a result of some AKI patients receiving renal dialysis services in the ESRD facility at the lower ESRD PPS base rate versus continuing to receive those services in the hospital outpatient setting.
The impact chart in section XVI.B.3.a of this final rule displays estimated QIP impacts for payment year (PY) 2020. The overall impact is an expected reduction in payment to all facilities of $31 million, with an estimated total facility burden for the collection of data of $91 million.
The DMEPOS CBP bidding entities will be impacted by the bid surety bond requirement as they will be required to purchase a bid surety bond for each CBA in which they are submitting a bid. The state licensure requirement will have no new impact on the supplier community because this is already a Medicare DMEPOS supplier requirement and the appeals process for a breach of a DMEPOS CBP contract actions expected to have a beneficial, positive impact on suppliers.
Overall, the bid surety bond requirement may have a positive financial impact on the program as CMS anticipates that the requirement will encourage all bidding entities to submit substantiated bids. However, there will be an administrative burden for implementation of the bid surety bond requirement for CMS. The final state licensure and appeals process for breach of DMEPOS CBP contract actions regulations will have minimal administrative costs.
We do not anticipate that the final DMEPOS CBP regulations for bid surety bonds, state licensure, and the appeals process for breach of DMEPOS CBP contract actions will have an impact on Medicare beneficiaries.
The overall economic impact for the final changes to the DMEPOS CBPs and Fee Schedule Adjustments would be about $20 million dollars in savings to the Part B Trust Fund over 5 years beginning January 1, 2017. The savings are a result of avoiding price inversions. This final rule should have a minor impact on the suppliers of CBAs and in the non-competitive bidding areas (non-CBAs). Beneficiaries would have lower coinsurance payments and receive the most appropriate items as a result of this final rule.
On January 1, 2011, we implemented the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS), a case-mix adjusted bundled PPS for renal dialysis services furnished by ESRD facilities as required by section 1881(b)(14) of the Social Security Act (the Act), as added by section 153(b) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275). Section 1881(b)(14)(F) of the Act, as added by section 153(b) of MIPPA and amended by section 3401(h) of the Patient Protection and Affordable Care Act (the Affordable Care Act) (Pub. L. 111-148), established that beginning with calendar year (CY) 2012, and each subsequent year, the Secretary of the Department of Health and Human Services (the Secretary) shall annually increase payment amounts by an ESRD market basket increase factor, reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act.
Section 632 of the American Taxpayer Relief Act of 2012 (ATRA) (Pub. L. 112-240) included several provisions that apply to the ESRD PPS. Section 632(a) of ATRA added section 1881(b)(14)(I) to the Act, which required the Secretary, by comparing per patient utilization data from 2007 with such data from 2012, to reduce the single payment for renal dialysis services furnished on or after January 1, 2014 to reflect the Secretary's estimate of the change in the utilization of ESRD-related drugs and biologicals (excluding oral-only ESRD-related drugs). Consistent with this requirement, in the CY 2014 ESRD PPS final rule we finalized $29.93 as the total drug utilization reduction and finalized a policy to implement the amount over a 3- to 4-year transition period (78 FR 72161 through 72170).
Section 632(b) of ATRA prohibited the Secretary from paying for oral-only ESRD-related drugs and biologicals under the ESRD PPS prior to January 1, 2016. And section 632(c) of ATRA required the Secretary, by no later than January 1, 2016, to analyze the case-mix payment adjustments under section 1881(b)(14)(D)(i) of the Act and make appropriate revisions to those adjustments.
On April 1, 2014, Congress enacted the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93). Section 217 of PAMA included several provisions that apply to the ESRD PPS. Specifically, sections 217(b)(1) and (2) of PAMA amended sections 1881(b)(14)(F) and (I) of the Act and replaced the drug utilization adjustment that was finalized in the CY 2014 ESRD PPS final rule (78 FR 72161 through 72170) with specific provisions that dictated the market basket update for CY 2015 (0.0 percent) and how the market basket should be reduced in CYs 2016 through CY 2018.
Section 217(a)(1) of PAMA amended section 632(b)(1) of ATRA to provide that the Secretary may not pay for oral-only ESRD-related drugs under the ESRD PPS prior to January 1, 2024. Section 217(a)(2) further amended section 632(b)(1) of ATRA by requiring that in establishing payment for oral-only drugs under the ESRD PPS, the Secretary must use data from the most recent year available. Section 217(c) of PAMA provided that as part of the CY 2016 ESRD PPS rulemaking, the Secretary shall establish a process for (1) determining when a product is no longer an oral-only drug; and (2) including new injectable and intravenous products into the ESRD PPS bundled payment.
Finally, on December 19, 2014, the President signed the Stephen Beck, Jr.,
Under the ESRD PPS, a single, per-treatment payment is made to an ESRD facility for all of the renal dialysis services defined in section 1881(b)(14)(B) of the Act and furnished to individuals for the treatment of ESRD in the ESRD facility or in a patient's home. We have codified our definitions of renal dialysis services at 42 CFR 413.171 and our other payment policies are included in regulations in subpart H to 42 CFR part 413. The ESRD PPS base rate is adjusted for characteristics of both adult and pediatric patients and accounts for patient case-mix variability. The adult case-mix adjusters include five categories of age, body surface area (BSA), low body mass index (BMI), onset of dialysis, four comorbidity categories, and pediatric patient-level adjusters consisting of two age categories and two dialysis modalities (42 CFR 413.235(a) and (b)).
In addition, the ESRD PPS provides for three facility-level adjustments. The first payment adjustment accounts for ESRD facilities furnishing a low volume of dialysis treatments (42 CFR 413.232). The second adjustment reflects differences in area wage levels developed from Core Based Statistical Areas (CBSAs) (42 CFR 413.231). The third payment adjustment accounts for ESRD facilities furnishing renal dialysis services in a rural area (42 CFR 413.233).
The ESRD PPS allows for a training add-on for home and self-dialysis modalities (42 CFR 413.235(c)). Lastly, the ESRD PPS provides additional payment for high cost outliers due to unusual variations in the type or amount of medically necessary care when applicable (42 CFR 413.237).
Policy changes to the ESRD PPS are proposed and finalized annually in the
On November 6, 2015, we published in the
The proposed rule, titled “End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care Model” (81 FR 42802 through 42880), hereinafter referred to as the CY 2017 ESRD PPS proposed rule, was published in the
In this final rule, we provide a summary of each proposed provision, a summary of the public comments received and our responses to them, and the policies we are finalizing for the CY 2017 ESRD PPS. Comments related to the paperwork burden are addressed in the “Collection of Information Requirements” section in this final rule. Comments related to the impact analysis are addressed in the “Economic Analyses” section in this final rule.
Since the composite rate payment system was implemented in the 1980s, we have reimbursed ESRD facilities for up to three hemodialysis (HD) treatments per week and only paid for weekly dialysis treatments beyond this limit when those treatments were medically justified due to the presence of specific comorbid diagnoses that necessitate additional dialysis treatments (see paragraph (c) of this section). When we implemented the ESRD PPS in 2011, we adopted a per treatment unit of payment (75 FR 49064). This per treatment unit of payment is the same base rate that is paid for all dialysis treatment modalities furnished by an ESRD facility (HD and the various forms of peritoneal dialysis (PD) (75 FR 49115). Consistent with our policy since the composite rate payment system was implemented in the 1980s, we also adopted the 3-times weekly payment limit for HD under the ESRD PPS (74 FR 49931). When a beneficiary's plan of care requires more than 3 weekly dialysis treatments, whether HD or daily PD, we apply payment edits to ensure that Medicare payment on the monthly claim is consistent with the 3-times weekly dialysis treatment payment limit. Thus, for a 30-day month, payment is limited to 13 treatments, and for a 31-day month payment is limited to 14 treatments.
Because PD is typically furnished more frequently than HD, we calculate HD-equivalent payment rates for PD that are based on the ESRD PPS base rate per treatment. To do this, we adjust the base rate by any applicable patient- or facility-level adjustments, and then multiply the adjusted base rate by 3 (the weekly treatment limit), and divide this number by 7. This approach creates a per treatment amount that is paid for each day of PD treatment and that complies with the monthly treatment payment limit. With regard to HD, because we do not have a payment mechanism for the ESRD facility to bill
In recent years, ESRD facilities have increasingly begun to offer HD where the standard treatment regimen exceeds 3 treatments per week. At the same time, we observed variation in how Medicare Administrative Contractors (MACs) processed claims for HD treatments exceeding three treatments per week, resulting in payment of more than 13 or 14 treatments per month. As a result, in the CY 2015 ESRD PPS final rule (79 FR 66145 through 66147), we reminded ESRD facilities and MACs that the Medicare ESRD benefit allows for the payment of 3 weekly dialysis treatments, and that additional weekly dialysis treatments may be paid only if there is documented medical justification. Additional conventional HD treatments are reimbursed at the full ESRD PPS payment if the facility's MAC determines the treatments are medically justified based on a patient condition, such as congestive heart failure or pregnancy. MACs have developed Local Coverage Determinations (LCDs) and automated processes to pay for all the treatments reported on the claim if the ESRD facility reports diagnoses determined by the MAC to medically justify treatments beyond 3 times per week.
The option to furnish more than 3 HD treatments per week is the result of evolving technology. We believe that, in some cases, use of this treatment option provides a level of toxin clearance on a weekly basis similar to that achieved through 3-times weekly conventional in-center HD. However, HD treatments exceeding 3 times per week are generally shorter and afford patients greater flexibility in managing their ESRD and other activities. As stated above, under the ESRD PPS, we currently do not have a payment mechanism that could apply a 3 treatments-per week equivalency to claims for patients with prescriptions for more than 3 HD treatments per week that do not have medical justification (see paragraph (c) of this section). As a result, the additional payments for treatments beyond 3 per week are denied, except where medically justified. Payment for HD treatments that exceed 3 treatments per week occurs when those treatments are medically justified, as indicated by diagnosis codes. There are specific conditions that require more medical attention, documentation in the medical record, and the results of the higher frequency treatments can be objectively measured through the collection of testing data and are therefore justified as necessary. In cases where the HD exceeds 3 treatments per week for reasons other than medical justification, there is a lack of objective data to justify additional payment for HD treatments beyond 3 treatments per week.
ESRD facilities have expressed concern that due to the monthly payment limit of 13 or 14 treatments, they are unable to report all dialysis treatments on their monthly claim, and therefore, they are not appropriately paid for each treatment furnished. We understand ESRD facilities' concerns and also would like to ensure that facilities are able to accurately report all of the treatments they furnish. Therefore, we analyzed 2015 ESRD facility claims data and found that there is a discrepancy between treatments furnished and treatments billed and paid for HD patients. The data indicate that HD patients are receiving HD treatments in excess of 3 per week, but facilities are usually only being paid for 3 treatments per week. The creation of an equivalency payment mechanism serves multiple purposes. First, it allows for payment for situations in which more than 3 HD treatments are furnished in a week that complies with the 3 treatment per week payment limit. Second, it encourages facilities to report all treatments furnished. This, in turn, would provide us with the information necessary to determine exactly how many treatments are being furnished. Finally, it would allocate the total amount of payment based on 3 HD sessions per week in accordance with the number of treatments actually furnished. For these reasons, we proposed a payment equivalency for HD treatment regimens when more than 3 treatments are furnished per week, similar to the HD-equivalency payment that has been used for PD since the composite rate payment system was implemented in 1983. While the policy would be effective January 1, 2017, we proposed not to implement the HD equivalency payments until July 1, 2017, to allow time to make operational changes to accommodate this new payment mechanism.
For CY 2017, for adult patients, we proposed to calculate a per treatment payment amount that would be based upon the number of treatments prescribed by the physician and would be composed of the ESRD PPS base rate as adjusted by applicable patient and facility-level adjustments, the home dialysis training add-on (if applicable), and the outlier payment adjustment (if applicable). To calculate the equivalency payment where more than 3 HD treatments are furnished per week, we would first adjust the ESRD PPS base rate by the applicable patient-level adjustments (patient age, body surface area, low body mass index, comorbidities, and onset of dialysis) and facility-level adjustments (wage index, rural facility, and low-volume facility). Second, we would multiply the adjusted ESRD PPS base rate by 3 to develop the weekly treatment amount and then we would divide this number by the number of treatments prescribed to determine the per treatment amount. Third, we would multiply the calculated outlier payment amount by 3 and divide this number by the number of treatments prescribed to determine the per treatment outlier amount. Finally, we would add the per-treatment ESRD PPS base rate and the per treatment outlier amount together to determine the final per treatment payment amount. For example, a beneficiary whose prescription indicates 5 treatments per week would be paid as follows: (Adjusted Base Rate * 3/5) + (Outlier Payment * 3/5) = per treatment payment amount.
While we proposed an equivalency payment based on 3 HD treatments per week, ESRD facilities submit bills monthly and, as a result, the monthly maximums presented below are the treatment limits that would be applied to 30-day and 31-day months:
For pediatric patients, the calculation would be the same as that proposed for adult patients, except that the ESRD PPS payment amount for pediatric patients would be based on the pediatric case mix adjustments and would not include the rural or low-volume facility-level adjustments.
In order to accommodate this policy change, we would establish new claim processing guidelines and edits that would allow facilities to report the prescribed number of HD treatments for each patient. There would be individual claims processing system identifiers established for treatments provided 4 times per week, 5 times per week, 6 times per week, and 7 times per week. These identifiers would allow the claims processing system to adjust the payment calculation and allow the appropriate payment for each treatment. The comments and our responses to the comments for these proposals are set forth in section II.B.1.d below.
While the majority of ESRD patients are prescribed conventional 3-times-per-week HD, we have always recognized that some patient conditions benefit from more than 3 HD sessions per week and as such, we developed a policy for payment of medically necessary dialysis treatments beyond the 3-treatments-per-week payment limit. Under this policy, the MACs determine whether additional treatments furnished during a month are medically necessary and when the MACs determine that the additional treatments are medically justified, we pay the full base rate for the additional treatments. While Medicare does not define specific patient conditions that meet the requirements of medical necessity, the MACs consider appropriate patient conditions that would result in a patient's medical need for additional dialysis treatments (for example, excess fluid). When such patient conditions are indicated on the claim, we instruct MACs to consider medical justification and the appropriateness of payment for the additional sessions.
The medical necessity for additional dialysis sessions must be documented in the patient's medical record at the dialysis facility and available for review upon request. The documentation should include the physician's progress notes, the dialysis records and the results of pertinent laboratory tests. The submitted medical record must support the use of the diagnosis code(s) reported on the claim and the medical record documentation must support the medical necessity of the services. This documentation would need to be available to the contractor upon request.
In section 50.A of the Medicare Benefit Policy Manual (Pub. 100-02), we explain our policy regarding payment for HD-equivalent PD and payment for more than 3 dialysis treatments per week under the ESRD PPS. This proposal does not affect our policy to pay the full ESRD PPS base rate for medically justified treatments beyond 3 treatments per week. Rather, the intent is to provide a payment mechanism for patients with more than 3 HD treatments per week that do not have medical justification. In the event that a beneficiary receives traditional HD treatments in excess of 3 per week without medical justification for the additional treatments, these additional treatments will not be paid. The comments and our responses to the comments for these proposals are set forth in section II.B.1.d below.
Beneficiary training is crucial for the long-term efficacy of home dialysis. Under our current policy for PD training, we pay the full ESRD PPS base rate, not the daily HD-equivalent payment amount, for each PD training treatment a beneficiary receives up to the limit of 15 training treatments for PD. As we discussed in section II.B.2 of the proposed rule (81 FR 42812) and in section II.B.2 below, we are investigating payments and costs related to training and plan to refine training payments in the future. Until that time, we believe that paying the full base rate during training continues to support home dialysis modalities. When training accompanies HD treatments exceeding 3 per week, the training would continue to be limited to 25 total sessions, in accordance with our policy for training for conventional HD.
Because the home dialysis training add-on under the ESRD PPS is applied to each treatment on training claims up to the applicable limits for HD or PD, we anticipate that ESRD facilities will appreciate the ability to receive payment for each training treatment when more than 3 HD treatments are furnished per week and training is furnished with each of those treatments. We believe this effect of our proposed policy would be beneficial to facilities and beneficiaries receiving HD treatment more than 3 times per week because, as mentioned above, under our current policy, our claim edits only allow payment for 13 or 14 HD treatments in a monthly billing cycle. This means that ESRD facilities can only bill for 13 or 14 treatments for the month and may not receive the full number of home dialysis training add-on for the treatments that would otherwise be billable because of these payment limits. We believe that permitting facilities to bill for training treatments that are furnished to beneficiaries receiving more than 3 HD treatments per week will allow these facilities to receive payment for training more consistently with how they are furnishing these treatments. We expect ESRD facilities to engage patients in the decision making process for determining the best candidates for additional weekly hemodialysis beyond 3 treatments per week and thoroughly discuss with the patient the potential benefits and adverse effects associated with more frequent dialysis. For example, while there could be potential quality of life and physiological benefits there is also risk of a possible increase in vascular access procedures and the potential for hypotension during dialysis.
In the CY 2017 ESRD PPS proposed rule (81 FR 42812), we explained that we believe this payment mechanism would provide several benefits. Facilities would be able to bill for treatments accurately and be paid appropriately for the treatments they furnish. This policy would provide clarity for the MACs and providers on billing and payment for HD regimens that exceed 3 treatments per week and assist MACs in determining which HD treatments should be paid at the equivalency payment rate and which HD treatments should be paid at the full base rate because the facility has provided adequate evidence of medical justification. Beneficiaries and facilities would have more flexibility to request and furnish patient-centered treatment options. Finally, the proposal would increase the accuracy of payments and data and would provide CMS the ability to monitor outcomes for beneficiaries utilizing various treatment frequencies.
The comments and our responses to the comments for the proposals related to payment for HD when more than 3 treatments are furnished per week are set forth below.
Other commenters indicated that their more frequent home dialysis resulted in more hours of dialysis treatment than is typically furnished in-center. One commenter pointed out that typically patients on more frequent dialysis generally treat 30-40 percent longer than patients receiving 3 times per week therapy in-center. Commenters also described the health advantages of nocturnal dialysis and other dialysis schedules that provide a similar level of toxin and fluid removal to in-center dialysis, but spread out the treatments over 4 or more days. Another commenter pointed out that with the same weekly volume of fluid to be removed it is clearly demonstrable that removal in five treatments is safer, protects vital organs and is far more stable for patients. This does not mean that all patients must be treated 5 times per week or that all patients receiving that frequency are necessarily fully dialyzed. Therefore, some flexibility in approach is necessary. The commenter concluded that dialysis patients are in general intolerant of fluid removal. Elderly nursing home patients are at greater risk of problems that can be alleviated substantially by more frequent dialysis.
Many other commenters urged CMS to provide payment for customizing the dialysis treatment to the patient. One commenter indicated that unlike in-center dialysis, which is one size fits all, they are able to tailor each treatment to their physical needs; for example, if the beneficiary has too much fluid after travelling, then a few extra, longer, slower treatments could be done to gently remove the fluid. The commenter stated that a diabetic controls their treatment by regulating their blood sugar, and a patient on dialysis should be allowed the same freedom to treat accordingly. More frequent treatments, as needed, are a must for maintaining maximum health. There must not be a one size fits all dialysis treatment mentality.
Several commenters objected to the proposed update to home HD payment policies because they believed that it locks in the 3-times-per-week schedule. The comments indicated that there is no research that supports capping the dialysis dose in such an unsafe way. A 3-day a week schedule requires a nearly 3-day “dialysis weekend” every week, which is a risky choice. Another commenter stated that 3-times-per-week dialysis (Monday, Wednesday, Friday and Tuesday, Thursday, Saturday schedules) was not based on clinical research, but rather was a way to dialyze two groups of patients and allow the nurses to have Sunday off. Another commenter believes the 3-times-per-week scheduling reflects the shortage of dialysis machines and supplies in the 1960s when HD began. Other commenters pointed out that alternative schedules are unavailable in-center, other than in very narrow circumstance where there is medical justification, and thus are generally furnished at home.
We acknowledge that the proposed HD equivalency would have maintained the current policy which limits monthly payment to 13 or 14 treatments, which reflects the number of treatments received by the vast majority of ESRD patients; but our intention was to provide more flexibility for patients, not to increase the overall amount of payment. Patients with certain medical conditions reportedly benefit from shorter and/or longer and more frequent HD and, as a result, MACs can approve additional treatments. While we have reviewed the studies regarding more frequent HD that have been conducted, many of the studies are too small in scope and do not provide a sufficient basis for a national payment policy change of this magnitude. In particular, in a literature review reported November 2015 in the American Journal of Kidney Diseases, titled “Timing of Dialysis Initiation, Duration and Frequency of Hemodialysis Sessions, and Membrane Flux: A Systematic Review for a KDOQI Clinical Practice Guideline”,
Dialysis organizations pointed out that use of the prescribed number of treatments as the basis of payment increases the burden. An LDO pointed
An MDO agreed and expressed serious reservations about substituting prescribed treatments for delivered treatments in the calculation of payments, as the proposal contemplates. The commenter indicated the proposed HD equivalency policy would increase the reporting burden in order to correct claims for patients who do not attend the prescribed number of treatments. The line item billing requirements would impose further burden in billing for patients treated on schedules, such as every other day treatments. Moreover, months ending in the middle of a week would pose additional complexity, since it would be necessary to use 2 monthly claims to determine whether there had been more than three treatments during the week.
The commenters stated these additional burdens would represent additional administrative cost for every dialysis provider, for every vendor supplying dialysis billing software, for every MAC receiving these claims, and for CMS itself. They stated that this will be particularly burdensome for smaller organizations and independent providers which are not highly automated and tightly integrated with clinical systems. Another organization representing nonprofit facilities pointed out that with all the other requirements being placed on providers, particularly smaller providers, they do not see how CMS' need for better data outweighs the additional burden at this time and strongly opposed CMS finalizing the proposal.
Many other commenters objected to the proposal to pay for shorter, more frequent HD in a similar manner as PD, pointing out that PD and home HD are vastly different therapies and should not be compared to one another clinically or paid as if they are equivalent therapies. The comments indicated that PD is currently paid as the equivalent to 3 treatments per week HD because it requires multiple exchanges per day to achieve the same basic outcomes for patients.
Many commenters recommended that CMS issue simple billing clarifications to ESRD facilities to encourage reporting of all treatments and remind the MACs that their LCD or similar policies should include criteria for additional, medically justified dialysis treatments. Otherwise, the commenters indicated that CMS' current policies are sufficient to meet the needs of beneficiaries, providers, and Medicare, and the HD equivalency is not necessary.
Another commenter pointed out that current reimbursement for more frequent home HD creates for this one particular therapy a reimbursement level that can be double that of conventional 3-times-per-week HD if all the HD treatments are paid as medically justified treatments. The commenter stated that the cost to the provider for additional treatments (beyond 3 per week) delivered at home with more frequent home HD should be a relatively small incremental cost as compared to the first 3 treatments per week. Within the reimbursement of the first 3 treatments (the conventional schedule) the cost of the machine, the patient training, the nursing support, etc., would already have been covered and the incremental cost for additional home HD treatments is strictly the treatment supplies.
The commenter stated that reimbursing for the additional treatments beyond 3 treatments per week at the full bundled base rate does not seem appropriate and creates at least the appearance of a profit incentive for providers (and their physician partners) to utilize this therapy. Patients should have access to more frequent home HD as a therapy option, but the reimbursement for this therapy should be more straightforward and transparent, and on a level playing field with other dialysis therapy options, such as conventional 3 times weekly HD or PD. The commenter believes the CMS equivalency proposal would do that.
The commenter suggested that CMS consider adding a new lower incremental treatment rate for home HD treatments beyond 3 treatments per week to cover the additional incremental supply cost beyond the first 3 treatments per week, if CMS feels that is appropriate and is interested in promoting more frequent home HD therapy. However, another commenter stated that dialysis centers not only incur the cost of supplies for the additional treatments, but also incur the cost for staff to manage the treatments. It makes sense they should be paid accordingly and therefore avoid costly emergency rooms visits for episodes of fluid overload or hyperkalemia.
Several commenters stated that Medicare reimbursement should signal its willingness to support safe schedules, especially every other day (EOD) HD schedules. The commenter recommended that the PPS should base home HD reimbursement on 7 treatments every 2 weeks, that is, reimburse home HD fully, equivalent to EOD schedules, and to reimburse a partial bundle amount for treatments in excess of EOD.
Other commenters implored CMS to explore paying for HD by the hour rather than by the treatment, or, minimally, to pay for up to 15 standard in-center HD treatments per month without medical justification to allow dialysis every other day and eliminate the 3-day dialysis weekend.
Another commenter objected to statements in the proposed rule stating that more frequent HD is the result of evolving or new technology. The commenter believes it is more accurate to say that the option to furnish more than 3 HD treatments per week is an existing option that is increasingly utilized because of evolving technology that facilitates treatment in the home setting, where more frequent HD is more feasible, as well as increasing awareness of the unsolved clinical problems that more frequent HD can positively address. The commenter also pointed out evidence that more frequent HD is not new and referred to a systematic review of clinical outcomes in patients on more frequent HD that studied patients who initiated more frequent hemodialysis in Asia, Europe, North America, and South America as early as 1972. In other words, more frequent hemodialysis was an internationally-recognized prescription long before the advent of the currently dominant home HD technology in the US.
One commenter expressed concern about the implication that a significant number of prescribed extra HD sessions are not predicated upon medical necessity. The commenter pointed out that more frequent HD requires a greater investment of time on therapy than thrice-weekly therapy, no matter how it is prescribed. This therapy is not prescribed for convenience. The commenter pointed out that CMS has noted that no HD session is without risks, and more frequent therapy would not be prescribed unless it is clinically necessary to address a particular patient's needs. The commenter believed suggesting otherwise is inconsistent with the responsible practice of medicine. Another commenter explained that the hemodynamic benefits are a major reason why doctors prescribe, and patients embrace, this form of therapy. As such, the hemodynamic benefits are at the very core of the basis for the medical necessity for more frequent HD therapy.
A dialysis nursing association expressed concern that despite the promulgation of LCDs for additional dialysis treatments, there are substantial differences in the MAC's assessment of medical justification for these treatments. They urged CMS to continue to educate the MACs on what constitutes medical justification and ensure the MACs are thoroughly examining each medical record in its entirety when assessing whether there is medical justification for additional treatments. They pointed out that differences in documentation requirements necessitate additional work for their members, and it is imperative that the MACs exhibit greater consistency when determining the appropriateness of payment based upon the medical documentation.
However, many other commenters, primarily physicians, implored Medicare not to interfere with the physician's clinical judgment in determining the best treatment regimen that meets the needs of their patients. Physicians indicated that all the treatments they prescribe are medically necessary. Several commenters expressed concern the proposal may limit the physician's freedom to prescribe additional HD sessions for patients who could benefit. Commenters pointed out that currently there is no national policy that restricts a physician's ability to prescribe medically appropriate extra HD sessions for their patients and that the decision about whether the therapy prescribed is medically appropriate is made locally, between the physician and the local MAC. The commenter expressed concern that the HD equivalency proposal may take away some of that freedom if certain language in the rule is not changed. One commenter stated they are not asking CMS to specify what the MACs should or should not pay for, but rather that CMS should leave that decision to physicians.
A clinical association stated that while they are generally supportive of the current medical justification approach, they noted that it can create administrative burdens and, in some cases, interfere with the patient-physician relationship. Due to the heterogeneity with which various MACs interpret what is medically justified, clinicians in some areas have less latitude to provide what they believe is medically justified care. For example, it may be appropriate for certain patients who have benefitted from a fourth dialysis session in 1 week to receive a fourth dialysis session in the following week as a prophylactic measure to prevent an adverse outcome from occurring again. The commenter believes CMS should urge all MACs to approach medical justification with a consistent, broad view and a respect for physicians' responsibility in determining, in consultation with their patients, what constitutes medically necessary additional dialysis sessions.
Another commenter agreed, stating that absence of documentation on some claims forms requesting payment for extra prescribed sessions does not indicate absence of medical necessity. Instead, it may be due to variations in the documentation particular MACs are seeking, or a misunderstanding of how to properly submit a claim for a type of therapy that is rarely prescribed. In these instances, documentation of medical necessity likely is to be found in the prescribing physician's patient records. The commenter stated that it is rational to assume that a reiteration of clear instructions on this point, from CMS and the MACs, would address the discrepancies in claims submissions that CMS has noted.
An advocacy organization asked that CMS reiterate again in final rulemaking that there is no national coverage decision for additional hemodialysis sessions, that the determination of medical justification for both acute and chronic prescriptions involving more than three sessions per week is left entirely to the discretion of the MACs and that if a MAC wishes to restrict coverage to any certain conditions or require any unique documentation, it must execute a formal LCD process with public comment.
Other commenters stated that the overwhelming clinical evidence shows that the closer HD treatment approximates the functioning of the healthy human kidney (24 hours/per day, 7 days/per week), the better the patient outcomes. Therefore, they believe Medicare should presume that longer, more frequent dialysis is medically justifiable in all cases, and that the actual treatment regimen should be determined by the patient, in consultation with their physician, taking into account both anticipated clinical outcomes and the patient's overall life goals.
Another commenter suggested that a conversation should be opened with Medicare contractors to permit a full understanding for the reasons for more frequent HD therapy. Justifications for on-going more frequent HD therapy are not necessarily the same as that for a one-time only justification for an extra treatment for a conventionally treated patient. The justifications for the two groups should be separated. The commenter stated that Medicare should unequivocally signal support for the concept of more frequent HD and should also clearly signal that more frequent HD treatments, when justified, will be funded. Lastly, the commenter stated that should more frequent HD be prescribed without justification, then treatments in excess of 3-per-week should not be reimbursed. Another commenter agreed, stating that all home HD treatments provided should be reported and, through use of a modifier, be indicated as medically supported or not medically supported with all supported treatments being paid at the designated HD facility rate.
However, another commenter pointed out that the need for more than 3 HD treatments per week occurs in less than 1 percent of the ESRD population and the need for additional treatments is very brief in duration. This commenter indicated that after receiving perhaps a few extra treatments, the patient should be able to be managed with 3 treatments a week. The commenter indicated that if facilities report a diagnostic code such as congestive heart failure (CHF), the extra treatments are automatically paid by the MAC without pre-payment review and, moreover, the MAC will continue to pay for these treatments as long as the diagnosis is included on the claim. The commenter believes that this payment procedure is an invitation to serious Medicare abuse and recommended that CMS demand pre-payment review of every patient requiring more than 3 treatments a week for a period of more than 1 week. Specifically, the facility should be required to provide monthly physician progress notes, chest x-ray reports, and other confirmatory testing and medical justification for the ongoing need for extra treatments and the patient's inability to return to 3 times a week treatments.
However, we reiterate that we are finalizing our proposal to pay the full ESRD PPS base rate for all training treatments even when they exceed 3 times per week with a limit of 25 sessions as proposed.
In 2014, Medicare paid approximately $30 million to ESRD facilities for home and self-dialysis training claims, $6 million of which is in the form of home dialysis training add-on payments. These payments accounted for 115,593 dialysis training treatments (77,481 peritoneal dialysis (PD) training treatments and 38,112 hemodialysis (HD) training treatments) for 12,829 PD beneficiaries and 2,443 HD beneficiaries. Hereinafter, we will refer to this training as home dialysis training. Under the ESRD PPS, there are three components to payment for home dialysis training: The base rate, a wage-adjusted home dialysis training add-on payment, and an allowable number of training treatments to which the training add-on payment can be applied.
When the ESRD PPS was implemented in 2011, we proposed that the cost for all home dialysis services would be included in the bundled payment (74 FR 49930), and therefore, the computation of the base rate included home dialysis training add-on payments made to facilities as well as all composite rate payments, which account for facility costs associated with equipment, supplies, and staffing. In response to public comments, in the CY 2011 ESRD PPS final rule (75 FR 49062), we noted that although we were continuing to include training payments in computing the ESRD PPS base rate, we agreed with commenters that we should treat training as an adjustment under the ESRD PPS. Accordingly, we finalized the home dialysis training add-on amount of $33.44 per treatment as an additional payment made under the ESRD PPS when one-on-one home dialysis training is furnished by a nurse for either HD or PD training or retraining (75 FR 49063). In addition, we continued the policy of paying the home dialysis training add-on payment for 15 training treatments for PD and 25 training treatments for HD. In 2011, the amount we finalized for the home dialysis training add-on was $33.44, which was updated from the previous adjustment amount of $20. This updated amount of $33.44 per treatment was based on the national average hourly wage for Registered Nurses (RN), from the Bureau of Labor Statistics (BLS) data updated to 2011 (75 FR 49063), and reflects 1 hour of training time by a RN for both HD and PD. Section 494.100(a)(2) of the Conditions for Coverage for ESRD Facilities stipulates that the RN must conduct the home dialysis training, but in the ESRD Program Interpretive Guidance published October 3, 2008 (
The $33.44 amount of the home dialysis training add-on was based on the national mean hourly wage for RNs as published in the Occupational Employment Statistics (OES) data compiled by BLS. This mean hourly wage was then inflated to 2011 by the ESRD wages and salaries proxy used in the 2008-based ESRD bundled market basket. In the calendar year (CY) 2014 ESRD PPS final rule (78 FR 72185), CMS further increased this amount from $33.44 to $50.16 to reflect 1.5 hours of training time by an RN in response to stakeholder concerns that the training add-on was insufficient.
In response to the CY 2016 ESRD PPS proposed rule, we received a significant number of stakeholder comments
While some commenters, primarily patients on home HD and a manufacturer of home HD machines, requested that we increase the home dialysis training add-on payment adjustment so that more ESRD patients could receive the benefit of home HD, we also heard from large dialysis organizations (LDOs) that the current home dialysis training add-on amount is sufficient. In addition to these differing viewpoints, we received public comments indicating a wide variance in training hours per treatment and the number of training sessions provided. As we indicated in the CY 2016 ESRD PPS final rule (80 FR 69004), patients who have been trained for home HD and their care partners have stated that the RN training time per session spanned from 2 to 6 hours per training treatment, that the number of training sessions ranged from 6 to 25 sessions, and that the training they received took place in a group setting. The range of hours per training treatment may indicate that the amount of RN training time gradually decreased over the course of training so that by the end of training, the patient was able to perform home dialysis independently.
In order to incentivize the use of PD when medically appropriate, Medicare pays the same home dialysis training add-on for all home dialysis training treatments for both PD and HD, even though PD training takes fewer hours per training treatment. It has never been our intention that the training add-on payment adjustment would reimburse a facility for all of its costs associated with home dialysis training treatments. Rather, for each home dialysis training treatment, Medicare pays the ESRD PPS base rate, all applicable case-mix and facility-level adjustments, and outlier payments plus a training add-on payment of $50.16 to account for RN time devoted to training. The home dialysis training add-on payment provides ESRD facilities with payment in addition to the ESRD PPS payment amount. Therefore, the ESRD PPS payment amount plus the $50.16 training add-on payment should be considered the Medicare payment for each home dialysis training treatment and not the home dialysis training add-on payment alone.
We are committed to analyzing the home dialysis training add-on to determine whether an increase in the amount of the adjustment is appropriate. To begin an analysis of the home dialysis training add-on payment adjustment, we looked at the information on 2014 ESRD facility claims and cost reports.
We analyzed the ESRD facility claims data to evaluate if the information currently reported provides a clear representation of the utilization of training. We note that after an initial home dialysis training program is completed, ESRD facilities may bill for the retraining of patients who continue to be good candidates for home dialysis. We indicated in the proposed rule that retraining is allowed for certain reasons as specified in the Medicare Claims Processing Manual (Pub 100-4, Chapter 8, section 50.8): The patient changes from one dialysis modality to another (for example, from PD to HD); the patient's home dialysis equipment changes; the patient's dialysis setting changes; the patient's dialysis partner changes; or the patient's medical condition changes (for example, temporary memory loss due to stroke, physical impairment) (81 FR 42813). We also noted that we are not able to differentiate training treatments from retraining treatments. That is, all training claims are billed with condition code 73, which is what an ESRD facility would use for both training and retraining treatments. Under the current claims processing systems, we are unable to identify in the data when the maximum number of training treatments have been completed, 25 for HD and 15 for PD, however, administrative guidance will be forthcoming on this issue. Therefore, we are unable to clearly tell when the patient is still training on the modality versus when they have completed the initial training and need retraining for one of these reasons provided in the claims processing manual noted above.
To be able to make informed decisions on future training payment policies we would need to have specificity regarding the utilization for each service. We are interested in assessing the extent to which patients are retrained and the number of retraining sessions furnished. The findings of this assessment will inform future decisions about how we compute the training add-on payment and whether we should consider payment edits for retraining treatments. For this reason, we stated our intention to issue sub-regulatory guidance to provide a method for facilities to report retraining treatments. We solicited input from stakeholders on retraining, how often retraining occurs, how much RN time is involved, and the most common reason for retraining.
A summary of these comments and our responses are provided below. In addition, historically ESRD facilities have indicated they are unable to report all treatments furnished on the monthly claim. For this reason, we believe the number of training treatments currently reported on claims may be inaccurate. As discussed in detail in section II.B.1.a of the proposed rule (81 FR 42813), there are claims processing edits in place that may prevent reporting of HD treatments, including both training and maintenance treatments, that exceed the number of treatments typically furnished for conventional HD, that is, 3 per week, unless the additional treatments are medically justified. This is because of the longstanding Medicare payment policy of basing payment on 3 HD treatments per week, which, for claims processing purposes is 13 to 14 treatments per month. For PD, which is furnished multiple times each day, ESRD facilities report a treatment every day of the month and MACs pay for these treatments by applying an HD-equivalent daily rate. We proposed a similar payment approach for HD treatments furnished more than 3 times per week, which would allow facilities to report all HD treatments furnished, but payment would be made based on a 3 treatments per week daily rate.
As we explain in section II.B.1 of this final rule, we are not finalizing the HD payment equivalency proposal due to the burden it would have on facilities, however, we are pursuing other methods for identifying medically justified treatments and treatments that do not meet the MAC's LCD for additional dialysis treatments, such as through the use of modifiers. We are also finalizing that we would not limit the number of home HD training treatments per week for which we would pay the full ESRD PPS base rate to be consistent with how we pay for PD training and to better align Medicare payments for training to when facilities are incurring the cost for training. We believe these changes will greatly improve the accuracy of the reporting of training treatments.
We solicited comments on implementing the HD payment equivalency and sought information on the use of retraining and the establishment of coding on the ESRD
A physician organization agreed, stating that some research has shown that individuals starting PD commonly develop complications like peritonitis, need hospitalization, and are transferred to catheter-based HD within the first 90 days of dialysis initiation. The organization noted that adapting to home dialysis is challenging and may indicate a need for improved initial training and a targeted increase in early retraining interventions.
Based on an informal survey of their members, the organization suggests that retraining is warranted in the following circumstances: After any episode of peritonitis, bacteremia, or infection in which root-cause analyses suggests that the condition resulted from a break in sterility of technique; after prolonged period of hospitalization or skilled nursing facility care, when the patient or caregiver may be out of practice; after changes in HD access (catheter to fistula or graft, new fistula or graft, especially if on the opposite side, or difficulty with cannulation at a particular part of a fistula or graft); training for use of a heparin pump; change in dialysis machine or equipment; when there is a change in who is going to perform or assist with home PD or HD (for example, if a patient has had a stroke and now their spouse will do PD or if one caregiver is replaced by another); when home dialysis patients move or transfer to another program (whether permanently or temporarily), reflecting that protocols, equipment and care practices may differ among programs.
An LDO indicated that in its experience retraining typically occurs at six-month intervals and following a hospitalization, infection, or return to therapy. The commenter agreed that in some circumstances, it can be difficult to differentiate training from retraining treatments. A patient advocacy organization urged CMS to allow flexibility for facilities to deliver retraining, when it is necessary, to ensure patients continue to dialyze safely at home. They also noted that training currently is and should continue to be individualized and tailored to the patients' needs and learning aptitude, and policies should remain flexible to ensure a patient-centered approach is attainable. A manufacturer stated that the first step will be to establish nomenclature and definitions. The commenter indicated that they plan to send a communication on this point separately, not as part of this comment process.
In the CY 2016 ESRD PPS final rule (80 FR 60093), we incorrectly cited the payment amount to facilities for HD training as $1,881 based on a total of 37.5 hours of training. The amount we should have cited is $1,254. This is the result of a multiplication error.
We did not receive any comments on this technical correction.
CMS evaluated 2014 ESRD cost report data in an effort to identify the nature of the specific costs reported by ESRD facilities associated with home dialysis training treatments. We found that there is a significant disparity among facilities with regard to their reported average cost per home dialysis training treatment particular to HD training, ranging from under $100 per treatment to as high as several thousand dollars per treatment. Because of this substantial variation, we believe that the cost report data we currently collect cannot be used to accurately gauge the adequacy of the current $50.16 amount of the per treatment training add-on and that additional cost reporting instructions are necessary. We believe that the cost difference between training treatment costs and maintenance treatment costs is primarily the additional staff time required for training and inconsistencies in how to report related costs. All other training costs, that is, equipment, supplies, and support staff are accounted for in the ESRD PPS base rate. Based on this understanding, extreme variations in staff time should not occur as the number of hours required should fluctuate only slightly for some patients depending on modality or other factors. However, one patient needing a total nursing time of 1-2 hours compared to another patient needing 50 hours for the same modality indicates a lack of precision in the data.
In response to these findings and in an effort to obtain a greater understanding of costs for dialysis facilities, and as we discussed in the CY 2017 ESRD PPS proposed rule (81 FR 42814), we are considering a 3-pronged approach to improve the quality and the value of the cost report data and to enable us to use the average cost per home dialysis training treatment reported by ESRD facilities to set the amount of the training add-on payment adjustment in the future. First, CMS would complete an in-depth analysis of cost report data elements. The analysis would assist CMS in determining what
Second, in accordance with section 217(e) of PAMA, CMS is currently performing comprehensive audits of ESRD facility cost reports. We anticipate the audits will also result in greater uniformity in reporting methods and in turn, heightened data quality in future years.
Third, we are considering an update to the independent ESRD facility cost report (CMS-265-11) to include new fields and to rework several worksheets in an effort to obtain more granularity in data on home dialysis training. Also, we are considering a locking mechanism that would prevent a facility from submitting a cost report if certain key fields have not been completed, such as those in Worksheet S, allowing CMS to capture the needed information to appropriately pay home dialysis training by an RN.
The comments and our responses to the comments for this 3-pronged strategy to improve the ESRD cost report data are set forth below.
One commenter indicated that new fields on the cost report can provide additional information on patient training resource allocation (among other issues), however, they strongly recommended that the new fields be designed to have clear and concise micro specifications (that is, specific description of definitions, criteria, and contents) to avoid ambiguity and multiple interpretations among dialysis facility personnel and vendors. They further recommended that these micro specifications be released for public comment in order for CMS to appreciate how the different stakeholders interpret them and to allow for feedback and questions, thereby allowing for clarification and modifications prior to implementation. They also urged CMS to implement changes in a manner that recognizes that providers have different cost reporting periods, requiring longer—at least 6 months—lead time to implement. As CMS begins this data collection and analysis initiative, they recommended inclusion of industry stakeholders to provide input on appropriate changes.
Another commenter indicated that the proposed approach to improving the quality of cost report data, and to improve the estimate of the cost of home training, is very reasonable, as long as the locking mechanism is implemented cautiously. New fields on cost reports will probably require new fields in electronic health records and bookkeeping systems. Users should receive warnings and notifications when they skip mandatory fields, to avoid last-minute crises when they discover that they have omitted required data. If not prepared by such warnings, commenters fear that the requirement to meet a filing deadline might lead some users to submit less precise data.
Another commenter strongly supports CMS' multi-pronged effort to improve the data associated with the cost of home dialysis training treatments. In their analysis of resources necessary to deliver home training, they found similar data variances, especially between those programs with a higher volume of home patients and those who were training only a few individuals. The commenters believe that the analysis and audits proposed will result in a greater understanding of common errors, and lead to agency clarification and guidance around the reporting elements that will greatly improve data quality.
MedPAC supports CMS' effort to collect more reliable data on the cost of providing home dialysis training. Once CMS collects sufficiently reliable data about the duration and composition of training treatments, MedPAC believes the agency should assess the need to adjust the training add-on payment amount from the current rate.
A dialysis industry organization had thoughtful suggestions on how the current cost report might be used in a way that avoids issues with data variability. They proposed using an alternative weighting scheme based on an analysis of total HD treatments versus PD treatments that yielded a training add-on payment of $229.83 for 2017. Using cost report data, the analysis established 4.65 hours of additional staff time per training treatment and RN hourly compensation of $49.43. As a result, the organization urged CMS to increase the proposed training add-on adjustment to $229.83 per treatment for 2017.
We appreciate the views expressed by commenters and are proceeding with changes to the ESRD facility cost report as proposed. As we work to improve the data reporting ability on claims and cost reports, we will keep in mind the various helpful suggestions made by commenters on this topic. We are considering various options for obtaining assistance from stakeholders, such as obtaining feedback via the ESRD Payment mailbox at
Based on our analysis of ESRD facility claims and cost reports which we
Under the ESRD PPS, and in accordance with section 1881(b)(14)(A)(i) of the Act, we implemented a single base rate that applies to all treatments, even though PD costs facilities less than HD in terms of staff time, equipment, and supplies. To be consistent with this payment approach for routine maintenance dialysis treatments, we implemented a single home dialysis training add-on for both PD and HD, even though home dialysis training for PD takes half the time per training treatment on average than HD.
In order to maintain this payment approach and provide an increase in the payment for home dialysis training treatments, we proposed an increase in the single home dialysis training add-on amount for PD and HD, based on the average treatment time for PD and HD and the percentage of total training treatments for each modality as a proxy for nurse training time as described below, until such time as we have data that concretely indicates what an adequate payment should be.
For wages, we proposed to use the latest Occupational Employment Statistics (
Since PD training is approximately 67 percent of total training treatments and takes an average of 2 hours per treatment and HD is 33 percent of total training treatments and takes an average of 4 hours per treatment, we proposed to base the payment for home dialysis training on 2.66 hours of treatment time ((.67 × 2 hours) + (.33 × 4 hours) = 2.66 hours) resulting in a training add-on payment of $95.57 (2.66 hours × $35.93 = $95.57). This would provide for an increase of $45.41 per training treatment (that is, $95.57−$50.16 = $45.41). This approach would provide a significant increase in payment for home dialysis training for CY 2017 while maintaining consistent payment for both PD and HD modalities.
As we did in CY 2014 when we last increased the training add-on payment, we proposed that the increase in the training add-on payment would be made in a budget neutral manner by applying a budget neutrality adjustment to the ESRD PPS base rate. The proposed increase resulted in a budget neutrality adjustment of 0.999729.
The comments and our responses to the comments for the proposed increase to the home dialysis training add-on are set forth below.
One LDO noted that dialysis modality selection is a complex decision for any individual and believes that too much attention has been paid to the training an individual receives (and the cost of such training) and too little has been paid to the myriad other factors that influence this decision. The commenter pointed out that numerous comment letters from the community and a recent report from the General Accounting Office (GAO) have identified factors that influence decisions regarding home dialysis, including everything from an individual's home life to their familial support structure to their clinical status, as well as their physician's familiarity with home therapies.
One commenter urged CMS to set separate payment rates for home HD and for PD training to eliminate any payment incentive for a center to favor PD training over the more-costly home HD training. The commenter indicated that the only incentive for choosing one mode of home dialysis over the other should be how closely each modality comes to making it possible for patient to meet his or her treatment and lifestyle goals, after being fully informed about the clinical and lifestyle implications of each type of dialysis modality. Another commenter expressed support for CMS' proposals to obtain better data, and noted that separately evaluating the adequacy of the payment for each unique modality may be warranted.
A physician stated that home HD is ultimately a better treatment option medically for many patients and would like to see improved access to home training. This commenter went on to explain that in order to accomplish this dialysis centers would need to invest additional resources into home training, and the physician is hopeful that the proposed increased training payment would allow for this. The commenter noted that in their experience most dialysis centers do not offer home HD training and those that do offer training usually have a long waitlist for patients to receive the training, resulting in delays in training for patients. The commenter indicated that applying the same training payment for PD and home HD seems to benefit PD because they have not experienced delays in training PD patients due to lack of staff resources. Finally, the commenter indicated that training treatments are an essential process to transitioning patients home safely and agrees that these treatments should all be paid.
With respect to the comments requesting that we establish separate training rates for PD and HD, we will take these views into account as we contemplate revisions to the cost report to better capture training costs. However, we note that historically, we have paid the same base rate and per treatment training add-on to both PD and HD to encourage use of PD for those patients who can benefit from that modality. As we explained in the CY 2011 ESRD PPS proposed rule (74 FR 49115), composite rate costs and separately billable payments are lower for PD, and as a result, the use of a modality payment variable would result in substantially lower payments for PD patients. We stated that we believed the substantially lower payments for PD patients that would result if modality were used as a payment adjuster in the ESRD PPS would discourage the increased use of PD for patients able to use that modality (74 FR 49967). Because we want to encourage home dialysis, in which PD is currently the prevailing mode of treatment, we adopted an ESRD PPS base rate that did not rely on separate payment rates based on modality.
With regard to the comment about the proposal to pay for all treatments during training, we will no longer apply weekly training limits during HD training. However, we continue to believe that the limit of 25 home HD training treatments is appropriate. In response to the CY 2011 ESRD PPS proposed rule, we received numerous comments requesting that CMS retain the existing policy that limits coverage of the total number of training treatments at the current levels of 15 for PD (CAPD and CCPD) and 25 for HD. In the CY 2011 ESRD PPS final rule (75 FR 49063, we agreed with the commenters and stated that under the ESRD PPS, we will continue the current cap on training treatments at 15 for PD (CAPD and CCPD) and 25 for HD training because most commenters indicated that they can complete training within these training treatment parameters. Based on an analysis of claims data, it appears that patients are still able to be trained for home dialysis within the existing limits and we are finalizing the proposal to pay the full base rate for all treatments furnished during home dialysis training, up to the current limits of 15 for PD and 25 for HD.
Many commenters argued that the training add-on is different than other adjusters. For example, case-mix adjusters seek to tailor the more general base rate to ensure that facilities are not penalized for caring for patients who require more resources than those who do not. So, while the rate goes up slightly for the more expensive patients, it is reduced for the less expensive patients. This approach seeks to even out the resources being provided.
However, due to the fact that the training rate is an add-on and not an adjuster, the commenter contends that the training add-on is not redistributing existing resources according to patient need. Rather, it is meant to reimburse facilities for additional costs that otherwise would not be necessary for the typical in-center patient. These costs are outside of the base rate and, as such, the commenter believes there is no rationale for making the adjustment budget-neutral.
The commenter acknowledged that CMS has historically made modifications to the home dialysis training add-on in a budget-neutral manner. However, given the ongoing concerns related to the integrity of the ESRD PPS bundle, underpayments, and the growing instability of the economics of the ESRD system overall, the commenter believes there is a solid rationale for changing this policy. The commenter indicated that the ESRD PPS bundle continues to erode each year and creating further erosion by imposing budget neutrality in the context of the training add-on is inappropriate. While it may be true that a 6-cents-per-treatment reduction is small, the problem is that the ongoing systemic reduction of the base rate places in-center patients, as well as those receiving home dialysis, at risk.
MedPAC, however, believes that CMS should make a change to the training add-on payment in a budget-neutral manner. They stated that it is unclear whether the proposed budget-neutrality adjustment factor accounts for any increase in the number of home HD training treatments eligible for Medicare payment that may result from the proposed claims adjudication process change and recommended that CMS clearly explain the methods used to calculate the budget-neutrality adjustment factor and identify the total number of training treatments accounted for by the factor.
In the CY 2011 ESRD PPS final rule, we explained that we received comments encouraging us to consider utilizing an add-on payment adjustment to pay for the costs of home dialysis training. In response to those comments, we explained that although we were continuing to include training payments in computing the ESRD PPS base rate, we agreed with commenters that we should treat training as an adjustment under the ESRD PPS. Thus, we finalized the home dialysis training add-on payment adjustment of $33.44 per treatment as an additional payment made under the ESRD PPS when one-on-one home dialysis training is furnished by a nurse for either hemodialysis or peritoneal dialysis training and retraining (75 FR 49063). We chose to calculate a home dialysis training add-on payment adjustment based on one hour of nursing time because it was similar to the existing training add-on payments under the basic case-mix payment system (75 FR 49062). The amount we finalized for the adjustment—$33.44 per training treatment—was updated from the previous adjustment amount of $20 per hour and was based on the national
We clarified our policy on payment for home dialysis training again in the CY 2013 ESRD PPS final rule in which we stated that training costs are included in the ESRD PPS base rate, however, we also provide an add-on adjustment for each training treatment furnished by a Medicare-certified home dialysis training facility (77 FR 67468). As such, we explained that it is not the intent of the add-on treatment to reimburse a facility for all of the training costs furnished during training treatments. Rather, the single ESRD PPS base rate, all applicable case-mix and facility-level adjustments, as well as the add-on payment should be considered the Medicare payment for each training treatment and not the training add-on payment alone. We noted that the fact that the add-on payment for training accounts for one hour of training time per treatment is not intended to imply that it only takes one hour per training session to properly educate a beneficiary to perform home dialysis.
Then in the CY 2014 ESRD PPS final rule (78 FR 72183), we concluded in response to public comments that the training add-on, which represented 1 hour of nursing time, did not adequately represent the staff time required to ensure that a patient is able to perform home dialysis safely. We had received numerous comments on the home dialysis training add-on payment adjustment raising concerns about access to home dialysis and identifying training elements that were not contemplated in 2011, such as self-cannulation and certain aspects of operating an HHD machine. As a result, we recomputed the add-on based upon 1.5 hours of nursing time per training treatment, which amounted to a 50 percent payment increase of $16.72 per training treatment in addition to the training treatment costs included in the base rate. Therefore, the add-on payment rose from $33.44 to $50.16. In calculating the budget neutrality factor, the historical number of home HD training treatments was used. We did not attempt to guess how much that number would change in the future under the new reporting principles. This is consistent with the approach taken for other issues in the past such as the number of patients with comorbidity adjusters or outlier thresholds. Historic data, not speculation about future behavior, were used to set the payment parameters. We have the flexibility to make adjustments budget neutral and have chosen to do so with past adjustments. Our decision to make the training add-on adjustment budget neutral is consistent with other past adjustments.
We believe increasing the training adjustment in a budget-neutral manner is appropriate. As noted above, we consider this increase to be a temporary accommodation while we collect cost and claims data to determine a more accurate training add-on payment adjustment in the future. We are increasing the training adjustment before we are able to collect that data to ensure continued access to this important modality. However, we do not believe it is appropriate to increase overall expenditures under the ESRD PPS during this interim period. As we note above, home dialysis training is also accounted for in the base rate and not just paid for through the home dialysis training adjustment. Because of this, we view moving dollars from the base rate to the home dialysis training adjustment as a way to effectively target this modality. When we have collected sufficient data to examine the cost and utilization of home dialysis training, we will be in a better position to evaluate whether it may be more appropriate to not make the adjustment budget neutral.
Finally, in terms of how we calculated the budget neutrality adjustment factor, we first evaluated the impact of increasing the home and self-dialysis training add-on from $50.16 (as of CY 2016) to $95.60 (which is being finalized for CY 2017). This was done by comparing the Medicare Allowable Payments (MAP) that were estimated under a PPS with the existing training add-on of $50.16 with those that were estimated under a PPS with the revised training add-on of $95.60. This comparison was made while holding other aspects of the ESRD PPS policy constant, and before determining estimated outlier payments. The number of training treatments estimated to be eligible for the adjustment was based on the most recent year of claims data. Training treatments were identified on 2015 claims containing pricer return codes that indicated the training adjustment was applied, which included 72,364 training treatments during 2015 based on the claims data used for the final rule. In estimating payments, the existing training-add on for CY 2016 and the revised training add-on for CY 2017 were applied to the eligible training treatments identified on the 2015 claims. The training budget neutrality adjustment factor was calculated as the ratio of the estimated MAP when applying the CY 2016 training add-on to the total estimated MAP when applying the CY 2017 training add-on. This calculation resulted in a training budget neutrality adjustment factor of 0.999737 for CY 2017.
Many other commenters pointed out that the proposed payment is a move in the right direction; however, the training add-on falls short of covering training costs. One commenter stated that while they appreciate CMS' proposal to increase the training add-on payment adjustment in 2017, they strongly urged CMS to raise the amount to $229.83 per treatment to better account for facility training costs. The commenters contend that the proposed amount simply does not adequately cover facility training costs to sufficiently promote and facilitate greater use of home and self-dialysis, particularly for small and medium dialysis facilities.
In order to provide additional payments to support home dialysis in the interim until we are able to make changes to the home dialysis training add-on based on claims and cost report data, we looked for a reasonable proxy for the home dialysis training add-on. We believe the interim rate, which is not intended to reflect the full cost of the RN, and almost doubles the current training add-on payment amount, is sufficient. Once reliable data is available, we will consider whether the adjustment needs to be increased or decreased.
However, another commenter pointed out that increasing the training add-on from 1.5 to 2.66 hours of RN labor is a move in the right direction. Providing training for patients and care partners is a critical element of facilitating and maintaining a home treatment regimen for the highest number of patients who are candidates for home dialysis. The commenter stated that as CMS works to improve their own data related to costs, this is an appropriate interim step.
Another commenter agreed indicating that the KDOQI guidelines are clinical practice guidelines which are not based on time studies of actual training sessions. While guidelines may provide an outline of the expected time for training sessions, they do not accurately represent the time spent training home dialysis patients. The commenter encouraged CMS to continue to research and evaluate this issue to align payments with the true cost of training services.
We thank the commenter for their suggestion. Our policy is to pay for 25 training treatments for home hemodialysis patients and 15 training treatments for peritoneal dialysis patients, which remains unchanged at this time. The goal of training is to ensure that beneficiaries are able to safely dialyze independently at home once complete. We do allow for additional retraining treatments under specific reasons detailed in the Medicare Claims Processing Manual (Pub 100-4, Chapter 8, section 50.8). We will consider this comment as we evaluate our training and retraining policies as we collect data.
We do not believe that use of the Outpatient Care Center group wage is a better reflection of the training performed by these RNs, and, for this reason, we are utilizing the BLS wage rate we proposed.
In accordance with section 1881(b)(14)(F)(i) of the Act, as added by section 153(b) of MIPPA and amended by section 3401(h) of the Affordable Care Act, beginning in 2012, the ESRD PPS payment amounts are required to be annually increased by an ESRD market basket increase factor and reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. The application of the productivity adjustment may result in the increase factor being less than 0.0 for a year and may result in payment rates for a year being less than the payment rates for the preceding year. The statute also provides that the market basket increase factor should reflect the changes over time in the prices of an appropriate mix of goods and services used to furnish renal dialysis services.
Section 1881(b)(14)(F)(i)(I) of the Act, as added by section 217(b)(2)(A) of PAMA, provides that in order to accomplish the purposes of subparagraph (I) with respect to 2016, 2017, and 2018, after determining the market basket percentage increase factor for each of 2016, 2017, and 2018, the Secretary shall reduce such increase factor by 1.25 percentage points for each of 2016 and 2017 and by 1.0 percentage point for 2018. Accordingly, for CY 2017, we proposed to reduce the amount of the market basket percentage increase by 1.25 percent and to further reduce it by the productivity adjustment.
We proposed to use the CY 2012-based ESRDB market basket as finalized and described in the CY 2015 ESRD PPS final rule (79 FR 66129 through 66136) to compute the CY 2017 ESRDB market basket increase factor and labor-related share based on the best available data. Consistent with historical practice, we estimate the ESRDB market basket update based on the IHS Global Insight (IGI), Inc. forecast using the most recently available data. IGI is a nationally recognized economic and financial forecasting firm that contracts with CMS to forecast the components of the market baskets.
As a result of these provisions, and using the IGI forecast for the first quarter of 2016 of the CY 2012-based ESRDB market basket (with historical data through the fourth quarter of 2015), the proposed CY 2017 ESRD market basket increase was 0.35 percent. This market basket increase was calculated by starting with the proposed CY 2017 ESRDB market basket percentage
For the CY 2017 ESRD payment update, we proposed to continue using a labor-related share of 50.673 percent for the ESRD PPS payment, which was finalized in the CY 2015 ESRD final rule (79 FR 66136).
We did not receive any comments on the proposed market basket update, multi-factor productivity (MFP) adjustment, or labor-related share.
Section 1881(b)(14)(D)(iv)(II) of the Act provides that the ESRD PPS may include a geographic wage index payment adjustment, such as the index referred to in section 1881(b)(12)(D) of the Act, as the Secretary determines to be appropriate. In the CY 2011 ESRD PPS final rule (75 FR 49117), we finalized the use of the Office of Management and Budget's (OMB) Core-Based Statistical Area (CBSA)-based geographic area designations to define urban and rural areas and their corresponding wage index values. OMB publishes bulletins regarding CBSA changes, including changes to CBSA numbers and titles. The latest bulletin, as well as subsequent bulletins, is available online at
For CY 2017, we stated that we would continue to use the same methodology as finalized in the CY 2011 ESRD PPS final rule (75 FR 49117) for determining the wage indices for ESRD facilities. Specifically, we are updating the wage indices for CY 2017 to account for updated wage levels in areas in which ESRD facilities are located. We use the most recent pre-floor, pre-reclassified hospital wage data collected annually under the inpatient prospective payment system. The ESRD PPS wage index values are calculated without regard to geographic reclassifications authorized under section 1886(d)(8) and (d)(10) of the Act and utilize pre-floor hospital data that are unadjusted for occupational mix. The final CY 2017 wage index values for urban areas are listed in Addendum A (Wage Indices for Urban Areas) and the final CY 2017 wage index values for rural areas are listed in Addendum B (Wage Indices for Rural Areas). Addenda A and B are located on the CMS Web site at
In the CY 2011 and CY 2012 ESRD PPS final rules (75 FR 49116 through 49117 and 76 FR 70239 through 70241, respectively), we also discussed and finalized the methodologies we use to calculate wage index values for ESRD facilities that are located in urban and rural areas where there is no hospital data. For urban areas with no hospital data, we compute the average wage index value of all urban areas within the State and use that value as the wage index. For rural areas with no hospital data, we compute the wage index using the average wage index values from all contiguous CBSAs to represent a reasonable proxy for that rural area.
We apply the wage index for Guam as established in the CY 2014 ESRD PPS final rule (78 FR 72172) (0.9611) to American Samoa and the Northern Mariana Islands. We apply the statewide urban average based on the average of all urban areas within the state (78 FR 72173) (0.8637) to Hinesville-Fort Stewart, Georgia. We note that if hospital data becomes available for these areas, we will use that data for the appropriate CBSAs instead of the proxy.
A wage index floor value has been used in lieu of the calculated wage index values below the floor in making payment for renal dialysis services under the ESRD PPS. In the CY 2011 ESRD PPS final rule (75 FR 49116 through 49117), we finalized that we would continue to reduce the wage index floor by 0.05 for each of the remaining years of the ESRD PPS transition. In the CY 2012 ESRD PPS final rule (76 FR 70241), we finalized the 0.05 reduction to the wage index floor for CYs 2012 and 2013, resulting in a wage index floor of 0.5500 and 0.5000, respectively. We continued to apply and to reduce the wage index floor by 0.05 in the CY 2013 ESRD PPS final rule (77 FR 67459 through 67461). Although our intention initially was to provide a wage index floor only through the 4-year transition to 100 percent implementation of the ESRD PPS (75 FR 49116 through 49117; 76 FR 70240 through 70241), in the CY 2014 ESRD PPS final rule (78 FR 72173), we continued to apply the wage index floor and continued to reduce the floor by 0.05 per year for CY 2014 and for CY 2015.
In the CY 2016 ESRD PPS final rule (80 FR 69006 through 69008), we finalized the continuation of the application of the wage index floor of 0.4000 to areas with wage index values below the floor, rather than reducing the floor by 0.05. We stated in that rule that we needed more time to study the wage indices that are reported for Puerto Rico to assess the appropriateness of discontinuing the wage index floor. Also, in that rule a commenter provided several alternative wage indexes for Puerto Rico for the CY 2016 ESRD PPS final rule: (1) Utilize our policy for areas that do not have reliable hospital data by applying the wage index for Guam as we did in implementing the ESRD PPS in the Northern Marianas and American Samoa; (2) use the U.S. Virgin Islands as a proxy for Puerto Rico, given the geographic proximity and its “non-mainland” or “island” nature; or (3) reestablish the wage index floor in effect in 2010 when Puerto Rico became the only wage areas subject to the floor, that is, 0.65.
For the CY 2017 proposed rule, we analyzed ESRD facility cost report and claims data submitted by facilities located in Puerto Rico and compared them to mainland facilities. Specifically, we analyzed CY 2013 claims and cost report data for 37 freestanding Puerto Rico facilities and compared it to 5,024 non-Puerto Rico freestanding facilities. We found that the freestanding facilities in Puerto Rico are bigger than facilities elsewhere in the United States. The Puerto Rico facilities produce roughly twice the number of treatments as other facilities and this larger size likely results in higher labor productivity. Finally, dialysis patients in Puerto Rico are much more likely to be non-Medicare. We discussed the findings in
Therefore, for CY 2017, we solicited public comments on the wage index for CBSAs in Puerto Rico as part of our continuing effort to determine an appropriate course of action. We did not propose to change the wage index floor for CBSAs in Puerto Rico, but requested public comments in which stakeholders can provide useful input for consideration in future decision-making. Specifically, we solicited comment on the useful suggestions that were submitted in last year's final rule (80 FR 69007) and reiterated above.
The comments and our responses to the comments for the proposal and solicitation are set forth below.
An organization of community stakeholders agreed, suggesting that CMS apply ESRD wage indexes in Puerto Rico that are consistent with other territories through the use of a temporary proxy. This group is requesting urgent administrative action from CMS. They are requesting that CMS: (1) Re-establish a fair and meaningful wage index floor given factual uncertainties and the demonstrated anomalies with the wage index for Puerto Rico; (2) Establish a temporary alternative wage index for Puerto Rico, given the observed disadvantage and the inconsistencies with the indexes used for other Territories; and (3) Ensure the corresponding adjustment in MA benchmarks for ESRD to secure the appropriate support to the Medicare program that serves 90 percent of all the Medicare A & B beneficiaries in Puerto Rico.
However, an industry organization expressed support for our current methodology for determining the wage indices and the continued application of the wage index floor of 0.4000.
One of the commenters who addressed the proposed wage index alternatives expressed an interest in basing the wage indices for Puerto Rico CBSAs on the wage values applied to other U.S. Territories and another commenter suggested applying the wage value for the U.S. Virgin Islands. The only other recommendation was maintenance of the current floor of 0.4000 with no comment on the alternatives in the proposed rule.
When we developed the wage indices for the Pacific Rim territories in the CY 2014 ESRD PPS final rule (78 FR 40845), we applied the methodologies we use to calculate wage index values for ESRD facilities that are located in urban and rural areas where there is no hospital data. Those policies were finalized in the CY 2011 and CY 2012 ESRD PPS final rules (75 FR 49116 through 49117 and 76 FR 70239 through 70241, respectively). For urban areas with no hospital data, we compute the average wage index value of all urban areas within the State and use that value as the wage index. For rural areas with no hospital data, we compute the wage index using the average wage index values from all contiguous CBSAs to represent a reasonable proxy for that rural area.
As we explained in the CY 2014 ESRD PPS final rule (78 FR 72172 through 72173), in the case of American Samoa and the Northern Mariana Islands, we determined that Guam represented a reasonable proxy because the islands are located within the Pacific Rim and share a common status as United States Territories. In addition, the Northern Marianas and American Samoa are rural areas with no hospital data. Therefore, we used the established methodology to compute an appropriate wage index using the average wage index values from contiguous CBSAs, to represent a reasonable proxy. While the islands of the Pacific Rim are not actually contiguous, we determined that Guam is a reasonable proxy for American Samoa and the Northern Marianas.
The primary difference between how we handled the wage index for the Pacific Rim islands and the situation in Puerto Rico is that we were able to rely upon existing policy for determining a wage index for areas with no hospital data for the Pacific Rim islands. We have hospital data upon which to base wage index values for Puerto Rico CBSAs, so our policy for CBSAs without wage index data does not apply to Puerto Rico, despite the fact that its, wage index data results in very low wage index values compared to other Territories and mainland CBSAs. This is a complex policy issue that cannot be resolved for CY 2017. We intend to continue analysis in this area so that we can address this issue in a future rulemaking.
A facility's wage index is applied to the labor-related share of the ESRD PPS base rate. In the CY 2015 ESRD PPS final rule (79 FR 66136), we finalized a new labor-related share of 50.673 percent, which was based on the 2012-based ESRDB market basket finalized in that rule, and transitioned the new labor-related share over a 2-year period. Thus, for CY 2017, the labor-related share to which a facility's wage index would be applied is 50.673 percent.
Section 1881(b)(14)(D)(ii) of the Act requires that the ESRD PPS include a payment adjustment for high cost outliers due to unusual variations in the
In the CY 2011 ESRD PPS final rule (75 FR 49142), we stated that for purposes of determining whether an ESRD facility would be eligible for an outlier payment, it would be necessary for the facility to identify the actual ESRD outlier services furnished to the patient by line item (that is, date of service) on the monthly claim. Renal dialysis drugs, laboratory tests, and medical/surgical supplies that are recognized as outlier services were originally specified in Attachment 3 of Change Request 7064, Transmittal 2033 issued August 20, 2010, rescinded and replaced by Transmittal 2094, dated November 17, 2010. Transmittal 2094 identified additional drugs and laboratory tests that may also be eligible for ESRD outlier payment. Transmittal 2094 was rescinded and replaced by Transmittal 2134, dated January 14, 2011, which was issued to correct the subject on the Transmittal page and made no other changes.
Furthermore, we use administrative issuances and guidance to continually update the renal dialysis service items available for outlier payment via our quarterly update CMS Change Requests, when applicable. We use this separate guidance to identify renal dialysis service drugs that were or would have been covered under Part D for outlier eligibility purposes and in order to provide unit prices for calculating imputed outlier services. In addition, we also identify through our monitoring efforts items and services that are either incorrectly being identified as eligible outlier services or any new items and services that may require an update to the list of renal dialysis items and services that qualify as outlier services, which are made through administrative issuances.
Our regulations at 42 CFR 413.237 specify the methodology used to calculate outlier payments. An ESRD facility is eligible for an outlier payment if its actual or imputed MAP amount per treatment for ESRD outlier services exceeds a threshold. The MAP amount represents the average incurred amount per treatment for services that were or would have been considered separately billable services prior to January 1, 2011. The threshold is equal to the ESRD facility's predicted ESRD outlier services MAP amount per treatment (which is case-mix adjusted) plus the fixed-dollar loss amount. In accordance with § 413.237(c) of our regulations, facilities are paid 80 percent of the per treatment amount by which the imputed MAP amount for outlier services (that is, the actual incurred amount) exceeds this threshold. ESRD facilities are eligible to receive outlier payments for treating both adult and pediatric dialysis patients.
In the CY 2011 ESRD PPS final rule, using 2007 data, we established the outlier percentage at 1.0 percent of total payments (75 FR 49142 through 49143). We also established the fixed-dollar loss amounts that are added to the predicted outlier services MAP amounts. The outlier services MAP amounts and fixed-dollar loss amounts are different for adult and pediatric patients due to differences in the utilization of separately billable services among adult and pediatric patients (75 FR 49140). As we explained in the CY 2011 ESRD PPS final rule (75 FR 49138 through 49139), the predicted outlier services MAP amounts for a patient are determined by multiplying the adjusted average outlier services MAP amount by the product of the patient-specific case-mix adjusters applicable using the outlier services payment multipliers developed from the regression analysis to compute the payment adjustments.
For the CY 2017 outlier policy, we used the existing methodology for determining outlier payments by applying outlier services payment multipliers that were developed for the CY 2016 ESRD PPS final rule (80 FR 68993-68994, 69002). We used these outlier services payment multipliers to calculate the predicted outlier service MAP amounts and projected outlier payments for CY 2017.
For CY 2017, we proposed that the outlier services MAP amounts and fixed-dollar loss amounts would be derived from claims data from CY 2015. Because we believe that any adjustments made to the MAP amounts under the ESRD PPS should be based upon the most recent data year available in order to best predict any future outlier payments, we proposed that the outlier thresholds for CY 2017 would be based on utilization of renal dialysis items and services furnished under the ESRD PPS in CY 2015. We recognize that the utilization of ESAs and other outlier services have continued to decline under the ESRD PPS, and that we have lowered the MAP amounts and fixed-dollar loss amounts every year under the ESRD PPS. We continue to believe that since the implementation of the ESRD PPS, data for CY 2015 are reflective of relatively stable ESA use, in contrast with the relatively large initial declines in the use of both EPO and darbepoetin in the first 2 years of the ESRD PPS. In 2015, there were both decreases in the use of EPO and increases in the use of darbepoetin based on estimates of average ESA utilization per session, suggesting a relative shift towards the use of darbepoetin between 2014 and 2015.
For CY 2017, we did not propose any change to the methodology used to compute the MAP or fixed-dollar loss amounts. Rather, we proposed to update the outlier services MAP amounts and fixed-dollar loss amounts to reflect the utilization of outlier services reported on 2015 claims. For this final rule, the outlier services MAP amounts and fixed-dollar loss amounts were updated using 2015 claims data. The impact of this update is shown in Table 1, which compares the outlier services MAP amounts and fixed-dollar loss amounts used for the outlier policy in CY 2016 with the updated estimates for this final rule. The estimates for the final CY 2017 outlier policy, which are included in Column II of Table 1, were inflation adjusted to reflect projected 2017 prices for outlier services.
As demonstrated in Table 1, the estimated fixed-dollar loss amount per treatment that determines the CY 2017 outlier threshold amount for adults (Column II; $82.92) is lower than that used for the CY 2016 outlier policy (Column I; $86.97). The lower threshold is accompanied by a decline in the adjusted average MAP for outlier services from $50.81 to $45.00. For pediatric patients, there is an increase in the fixed-dollar loss amount from $62.19 to $68.49, and a decrease in the adjusted average MAP for outlier services from $39.20 to $38.29.
We estimate that the percentage of patient months qualifying for outlier payments in CY 2017 will be 6.7 percent for adult patients and 4.6 percent for pediatric patients, based on the 2015 claims data. The pediatric outlier MAP and fixed dollar loss amounts continue to be lower for pediatric patients than adults due to the continued lower use of outlier services (primarily reflecting lower use of ESAs and other injectable drugs).
In the CY 2011 ESRD PPS final rule (75 FR 49081), in accordance with 42 CFR 413.220(b)(4), we reduced the per treatment base rate by 1 percent to account for the proportion of the estimated total payments under the ESRD PPS that are outlier payments. Based on the 2015 claims, outlier payments represented approximately 0.93 percent of total payments, close to the 1 percent target. Recalibration of the thresholds using 2015 data is expected to result in aggregate outlier payments close to the 1 percent target in CY 2017. We believe the update to the outlier MAP and fixed-dollar loss amounts for CY 2017 will increase payments for ESRD beneficiaries requiring higher resource utilization and move us closer to meeting our 1 percent outlier policy. We note that recalibration of the fixed-dollar loss amounts in this final rule would result in no change in payments to ESRD facilities for beneficiaries with renal dialysis items and services that are not eligible for outlier payments, but would increase payments to ESRD facilities for beneficiaries with renal dialysis items and services that are eligible for outlier payments. Therefore, beneficiary co-insurance obligations would also increase for renal dialysis services eligible for outlier payments.
The comments and our responses to the comments for the proposal to update the outlier thresholds using CY 2015 data are set forth below.
Other industry organization indicated that, since the outlier threshold has not been met since the implementation of the ESRD PPS and continues to fall short of 1 percent, CMS should propose a 0.5 outlier percentage for CY 2018. This 0.5 percent outlier percentage would reduce the offset to the base rate yet continue to provide payment for extraordinary costs. An MDO would prefer that CMS remove the outlier provision from the payment system, however, they understand that an outlier policy is statutorily required. Since CMS does not have the authority to remove the provision, they also suggested that the outlier percentage be reduced to 0.5 percent.
A professional association stated that they appreciate the efforts of CMS to recognize that the needs of all patients are not universally equal, and that a minority of patients will require treatments that carry markedly higher costs than the average ESRD patient. They support the concept of an outlier policy to sufficiently reimburse dialysis facilities for implementing necessary dialysis-related treatments to meet the needs of these patients and established therapeutic goals. However, in their view the outlier payments amount should equal the withhold amount.
As CMS continues to assess the outlier policy in future years, they suggested that future adjustments to the threshold for outlier payments be done annually to fully expend the withholding or adjust the withholding based on the running average expenditures from the prior 3 years (not to exceed 1 percent).
Also discussed in the CY 2016 ESRD PPS final rule (80 FR 69010 through 69011) we acknowledge that the 1.0 percent target has not been achieved since 2011 primarily because our annual update of the fixed-dollar loss amounts and MAP amounts could not keep up with the continued decline in the use of outlier services (primarily ESAs). That is, facilities incurred lower costs than anticipated, and those savings accrued to facilities more than offsetting the extent to which the consequent outlier payments fell short of the 1.0 percent target. In last year's rule we stated that we believed that decline was leveling off, which would make our projections of outlier payments more accurate. Using the most recent data, we found outlier payments to come close to the 1 percent target (at 0.93 percent). Outlier payments may not have reached 1 percent during 2015 primarily due to patterns in ESA utilization. There is evidence in the 2015 claims of increased use of epoetin beta, which may have been used as a lower cost substitute for other ESAs (at a clinically equivalent dose) and contributed to a decrease in the average outlier service MAP amounts for 2015.
With regard to the suggestion that we annually adjust the withholding based on the running average of the expenditure from the prior three years, with the total withholding not to exceed 1.0 percent, as we explain above, each year we simulate payments under the ESRD PPS in order to set the outlier fixed-dollar loss and MAP amounts for adult and pediatric patients to try to achieve the 1.0 percent outlier policy. We would not increase the base rate to account for years where outlier payments were less than 1.0 percent of total ESRD PPS payments and, more importantly we would not reduce the base rate if the outlier payments exceed 1.0 percent of total ESRD PPS payments. Rather than increasing and decreasing the base rate, we re-estimate the fixed-dollar loss threshold and MAP amounts so that outlier payments in the following year are 1.0 percent of total ESRD PPS payments. This is the approach used in other Medicare payment systems that include an outlier policy, such as the Inpatient Psychiatric Facility PPS. As we have done since 2011, we will continue to monitor outlier payments and assess annually the extent to which adjustments need to be made in the fixed-dollar loss and MAP amounts in order to achieve outlier payments that are 1.0 percent of total ESRD PPS payments.
In the CY 2011 ESRD PPS final rule (75 FR 49071 through 49083), we discussed the development of the ESRD PPS per treatment base rate that is codified in the Medicare regulations at §§ 413.220 and 413.230. The CY 2011 ESRD PPS final rule also provides a detailed discussion of the methodology used to calculate the ESRD PPS base rate and the computation of factors used to adjust the ESRD PPS base rate for projected outlier payments and budget neutrality in accordance with sections 1881(b)(14)(D)(ii) and 1881(b)(14)(A)(ii) of the Act, respectively. Specifically, the ESRD PPS base rate was developed from CY 2007 claims (that is, the lowest per patient utilization year as required by section 1881(b)(14)(A)(ii) of the Act), updated to CY 2011, and represented the average per treatment Medicare Allowable Payment (MAP) for composite rate and separately billable services. In accordance with section 1881(b)(14)(D) of the Act and regulations at § 413.230, the ESRD PPS base rate is adjusted for the patient specific case-mix adjustments, applicable facility adjustments, geographic differences in area wage levels using an area wage index, as well as applicable outlier payments or training payments.
The ESRD PPS base rate for CY 2017 is $231.55. This update reflects several factors, described in more detail below.
In summary, the final CY 2017 ESRD PPS base rate is $231.55. This amount reflects a payment rate update of 0.55 percent, the CY 2017 wage index budget-neutrality adjustment factor of 0.999781, and the home dialysis training add-on payment adjustment budget-neutrality adjustment of 0.999737.
The comments and our responses to the comments for the base rate proposals are set forth below:
We received many comments from Medicare beneficiaries, family members, ESRD facilities, nurses, physicians, professional organizations, renal organizations, and manufacturers related to issues that were not specifically addressed in the CY 2017 ESRD PPS proposed rule. Some of these comments are discussed below.
A congressional delegation also submitted a comment regarding the application of the TDAPA for an injectable drug that replaces iron and maintains hemoglobin in dialysis patients. An industry organization, an MDO, and a pharmaceutical company had similar concerns, adding that the benefits of new injectable drugs must be accounted for as an increase in the bundle, and specifically pointed to an injectable calcimimetic that has not received FDA approval to date.
An LDO and an MDO stressed that the drug designation policy is a critical issue for ESRD providers and urges CMS to confirm and clarify how the drug designation policy will be implemented. These commenters also asked for clarification regarding how payment for oral-only drugs that will be transitioned into the bundle as well.
With regard to the application of the TDAPA for an injectable anemia management drug, the anemia management functional category is one of the drug categories for which we have included dollars in the base rate and that has been updated with the annual ESRD market basket percentage increase factor. As a result, there is no separate transitional drug-add-on payment adjustment available for drugs and biologicals that manage an ESRD beneficiary's anemia. As we stated above, the transitional drug add-on adjustment payment is intended to capture those drugs and biologicals that are not reflected in the base rate. We note that drugs and biologicals that are accounted for in the ESRD PPS base rate could qualify as an outlier service when the manufacturer reports the Average Sales Price to CMS.
Finally, another commenter urges CMS to reevaluate and update the pediatric case mix adjuster utilizing the most recent data available. This commenter elaborates that pediatric patients have an increased level of acuity of nursing care when compared to adult dialysis patients, these patients often need developmental or behavioral specialists, social workers or school-based specialists to assist with optimizing school performance, as well as increased assessments from dietitians to adjust formulas and diet for the patient's growth and nutrition requirements. The array of dialysis supplies required by these patients is also broader.
Another LDO urged CMS to repair the underlying methodology of the ESRD PPS, which, based on their analysis, results in millions of dollars intended by CMS for patients' care to leak from the system. The organization stated that returning resources to the ESRD base rate will improve treatment for all Medicare dialysis beneficiaries, including home dialysis patients.
An industry organization commented that the ESRD PPS has underpaid providers by over $1 billion since 2011 and are predicting negative profit margins through 2018. The organization provided the same critique of the ESRD PPS regression methodology that they provided in response to the CY 2016 ESRD PPS proposed rule, reiterating their view that the ESRD PPS refinement regression methodology used by CMS violates the core assumptions for a valid analysis.
One commenter noted that the U.S. Food and Drug Administration approvals for dialysis machines for home use require that the patient have a care partner who can assist in emergencies. This requirement prevents people who live alone (or whose care partner is temporarily absent) from doing home HD, and may place an undue burden on the family unit. The commenter believes that a dialyzer should be able to choose to perform home HD with or without a care partner, as their training and comfort level dictates. The ESRD facility should discuss with the patient the risks of dialyzing alone, assess the dialyzer's ability to perform his or her own treatments without assistance, and discuss alternate safety precautions available to the patient if the patient chooses to forego having a care partner.
One LDO expressed concern that some home HD machines are designed in such a way that the patient must dialyze more frequently than three times per week and has found that a significant number of patients “burn out.” That is, they begin therapy on home HD but later decide they cannot effectively manage such a complex task at home and choose to dialyze in-center instead. The LDO's own data indicate that the average year-over-year “burn out” rate for home HD is 42 percent, compared to 24 percent for their PD patients. The primary cause for the drop-off among home HD patients is the burden on the patient's care partner.
Another commenter suggested that CMS standardize the elements of the training manuals across dialysis machine manufacturers for patients. The commenter noted that they appreciated having a professionally written training manual, which was provided by one manufacturer, and believes that similar manuals would enhance dialyzer's confidence in what they were learning. Another improvement the commenter suggested is to require that training clinic managers be more experienced. The commenter described their experience of having a training clinic that only required 3 months of training experience for their clinical nurse managers. The commenter believes that this amount of training experience does not seem sufficient for them to manage their staff and know how to evaluate and improve their work. The commenter also suggested that CMS implement a requirement for ongoing home dialysis training because in the commenter's experience when some training clinics
Another commenter noted that home dialysis innovations are limited by the local scale of the provider census and the resultant experience of providers' training programs. In the current ESRD market, home dialysis training is a small percentage of the activity at any single center; therefore, the level of expertise needed to develop certain skills and cost benefits is unattainable for many. As an alternative to the current model, many have identified the need for regional home training centers that service a network of traditional dialysis centers. Yet regional training centers are not the norm because centers do not want to refer patients to other programs for fear of losing the patient and their corresponding revenue. The commenter stated that CMS should strive to
On June 29, 2015, the Trade Protection Extension Act of 2015 (TPEA) (Pub. L. 114-27) was enacted. In the TPEA, the Congress amended the Act to include coverage and provide for payment for dialysis furnished by an ESRD facility to an individual with AKI. Specifically, section 808(a) of the TPEA amended section 1861(s)(2)(F) of the Social Security Act (the Act by including coverage for renal dialysis services furnished on or after January 1, 2017 by a renal dialysis facility or provider of services currently paid under section 1881(b)(14) of the Act to an individual with AKI. In addition, section 808(b) of TPEA amended section 1834 of the Act by adding a new subsection (r). Subsection (r)(1) of section 1834 of the Act provides that in the case of renal dialysis services (as defined in subparagraph (B) of section 1881(b)(14) of the Act) furnished under Part B by a renal dialysis facility or a provider of services paid under such section during a year (beginning with 2017) to an individual with acute kidney injury, the amount of payment under Part B for such services shall be the base rate for renal dialysis services determined for such year under such section, as adjusted by any applicable geographic adjustment applied under subparagraph (D)(iv)(II) of such section and may be adjusted by the Secretary (on a budget neutral basis for payments under section 1834(r) of the Act) by any other adjustment factor under subparagraph (D) of section 1881(b)(14) of the Act. Section 1834(r)(2) of the Act defines “individual with acute kidney injury” to mean an individual who has acute loss of renal function and does not receive renal dialysis services for which payment is made under section 1881(b)(14) of the Act.
The proposed rule, titled “End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care Model” (81 FR 42802 through 42880), was published in the
In this final rule, we provide a summary of each proposed provision, a summary of the public comments received and our responses to them, and the policies we are finalizing for the Coverage and Payment for Renal Dialysis Services Furnished to Individuals with AKI. Comments related to the impact analysis are addressed in the “Economic Analyses” section in this final rule.
Consistent with section 1834(r)(2) of the Act, we proposed to define an individual with AKI as an individual who has acute loss of renal function and does not receive renal dialysis services for which payment is made under section 1881(b)(14) of the Act. Section 1881(b)(14) of the Act contains all of the provisions related to the ESRD PPS. We interpret the reference to section 1881(b)(14) of the Act to mean that we would pay renal dialysis facilities for renal dialysis services furnished to individuals with acute loss of kidney function when the services furnished to those individuals are not payable under section 1881(b)(14) of the Act because the individuals do not have ESRD. We proposed to codify the statutory definition of individual with acute kidney injury at 42 CFR 413.371 and we solicited comments on this definition.
The comments and our responses to the comments for this proposal are set forth below.
One industry organization commented that CMS should reaffirm the distinct needs of AKI patients and support the flexibility for physicians to determine the classification, frequency of treatment, and types of services provided to these patients. A dialysis organization stated that the most meaningful definition for an AKI patient would be “a patient needing dialysis who does not require acute inpatient care for whom the nephrologist believes that there is a reasonable chance of kidney function recovery, and for whom the nephrologist therefore declines to sign the form 2728 (the physician's certification that a patient has reached stage 5 chronic kidney disease, or end-stage renal disease)”. A patient advocacy group recommended that CMS convene a technical expert panel of dialysis clinicians, nephrologists, and beneficiary organization to discuss how AKI patients can have guaranteed access to this new benefit.
Section 1834(r)(1) of the Act, as added by section 808(b) of TPEA, provides that the amount of payment for AKI services shall be the base rate for renal dialysis services determined for a year under section 1881(b)(14) of the Act. We proposed to interpret this provision to mean the ESRD PPS per treatment base rate as set forth in 42 CFR 413.220, which is updated annually by the market basket less the productivity adjustment as set forth in 42 CFR 413.196(d)(1), and adjusted by any other adjustment factor applied to the ESRD PPS base rate. The ESRD PPS per-treatment base rate is established on an annual basis through rulemaking and finalized in the CY ESRD PPS final rule. We recognize that there could be rulemaking years in which legislation or policy decisions could directly impact the ESRD PPS base rate because of changes to ESRD PPS policy that may not relate to the services furnished for AKI dialysis. For example, for CY 2017 we are applying a training add-on budget-neutrality adjustment factor to the otherwise applicable base rate. In those situations, we would still consider the ESRD PPS base rate as the payment rate for AKI dialysis. We believe that the statute was clear in that the payment rate for AKI dialysis shall be the ESRD PPS base rate determined for a year under section 1881(b)(14) of the Act, which we interpret to mean the finalized ESRD PPS base rate and not to be some other determined amount. As described below, ESRD facilities will have the ability to bill Medicare for non-renal dialysis items and services and receive separate payment in addition to the payment rate for AKI dialysis. For example, beneficiaries with AKI may require certain laboratory tests so that their practitioner can gauge organ function and accurately adjust the dialysis prescription that would be optimal for kidney recovery. These beneficiaries would require laboratory tests specific to their condition which would not be included in the ESRD PPS and thus, would be paid for separately. For instance, an individual with AKI might need to be tested for a biochemical indication of a urea cycle defect resulting in hyperammonemia. We proposed to codify the AKI dialysis payment rate in our regulations at 42 CFR 413.372 and solicited comment on this proposal.
The comments and our responses to the comments for this proposal are set forth below.
The CY 2017 final ESRD PPS base rate is $231.55. Accordingly, we are finalizing a CY 2017 payment rate for renal dialysis services furnished by ESRD facilities to individuals with AKI as $231.55.
Section 1834(r)(1) of the Act further provides that the amount of payment for AKI dialysis services shall be the base rate for renal dialysis services determined for a year under section 1881(b)(14) of the Act, as adjusted by any applicable geographic adjustment factor applied under section 1881(b)(14)(D)(iv)(II) of the Act. We interpret the reference to “any applicable geographic adjustment factor applied under section (D)(iv)(II)” of such section to mean the geographic adjustment factor that is actually applied to the ESRD PPS base rate for a particular facility. Accordingly, we proposed to apply the same wage index that is used under the ESRD PPS that is based on the most recent pre-floor, pre-reclassified hospital wage data collected annually under the inpatient prospective payment system that are unadjusted for occupational mix to the AKI dialysis payment rate. The ESRD PPS wage index policy was finalized in the CY 2011 ESRD PPS final rule (75 FR 49117) and codified at 42 CFR 413.231. We explained in the CY 2017 ESRD PPS proposed rule (81 FR 42821) that the AKI dialysis payment rate would be adjusted by the wage index for a particular facility in the same way that the ESRD PPS base rate is adjusted by the wage index for that facility. Specifically, we would apply the wage index to the labor-related share of the ESRD PPS base rate that we will utilize for AKI dialysis to compute the wage-adjusted per-treatment AKI dialysis payment rate. We proposed that for CY 2017, the AKI dialysis payment rate would be the CY 2017 ESRD PPS base rate (established in the CY 2017 ESRD PPS final rule), adjusted by the ESRD facility's wage index. In proposed 42 CFR 413.372(a), we refer to the ESRD PPS wage index regulation at 42 CFR 413.231 as an adjustment we will apply to the ESRD PPS base rate.
The comments and our responses to the comments for these proposals are set forth below.
Section 1834(r)(1) of the Act also provides that the payment rate for AKI dialysis may be adjusted by the Secretary (on a budget neutral basis for payments under section 1834(r) of the Act) by any other adjustment factor under subparagraph (D) of section 1881(b)(14) of the Act. For purposes of payment for AKI dialysis, we did not propose to adjust the AKI payment rate by any other adjustments at this time. Therefore, for at least the first year of implementation of the AKI payment rate, we did not propose to apply any of the optional payment adjustments under subparagraph (D) of section 1881(b)(14) of the Act. We proposed to codify our authority to adjust the AKI payment rate by any of the adjustments under section 1881(b)(14)(D) of the Act in our regulations at 42 CFR 413.373.
The comments and our responses to the comments for these proposals are set forth below.
A health system disagreed with the CMS' proposal of paying the ESRD base rate with no adjustments and expressed that the AKI patients cost substantially more than ESRD patients. The commenter suggested that CMS develop an AKI adjustor to be applied to the ESRD PPS base rate. A dialysis industry association suggested that in the future, CMS apply patient and facility-level adjustments to the AKI dialysis payment rate, similar to how CMS adjusts for ESRD beneficiaries.
With regard to the higher costs associated with AKI patients as compared to ESRD patients, we are finalizing a policy of paying for all treatments provided to a patient, without applying the monthly treatment limits applicable under the ESRD PPS. We are also finalizing a policy to pay separately for all items and services that are not part of the ESRD PPS base rate. Once we have substantial data related to the AKI population and its associated utilization, we will determine the appropriate steps toward further developing the AKI payment rate.
Section 1834(r)(1) of the Act provides that the AKI payment rate applies to renal dialysis services (as defined in subparagraph (B) of section 1881(b)(14) of the Act) furnished under Part B by a renal dialysis facility or provider of services paid under section 1881(b)(14) of the Act. We proposed that drugs, biologicals, laboratory services, and supplies that are considered to be renal dialysis services under the ESRD PPS as defined in 42 CFR 413.171, would be considered to be renal dialysis services for patients with AKI. As such, no separate payment would be made for renal dialysis drugs, biologicals, laboratory services, and supplies that are included in the ESRD PPS base rate when they are furnished by an ESRD facility to an individual with AKI. We proposed to codify this policy in the regulations at 42 CFR 413.374(a).
However, we recognize that the utilization of items and services for beneficiaries with AKI receiving dialysis may differ from the utilization of these same services by ESRD beneficiaries. This is because we expect that individuals with AKI will only need dialysis for a finite number of days while they recover from kidney injury, while ESRD beneficiaries require dialysis indefinitely unless they receive a kidney transplant. We recognize that the intent of dialysis for patients with AKI is curative; therefore, we proposed to pay for all hemodialysis treatments furnished to beneficiaries with AKI in a week, even if the number of treatments exceeds the three times-weekly limitation we apply to HD treatments furnished to beneficiaries with ESRD.
Other items and services furnished to beneficiaries with AKI that are not considered to be renal dialysis services as defined in 42 CFR 413.171, but that are related to their dialysis treatment as a result of their AKI and that an ESRD facility might furnish to a beneficiary with AKI, would be separately payable. In particular, an ESRD facility could seek separate payment for drugs, biologicals, laboratory services, and supplies that ESRD facilities are certified to furnish and that would otherwise be furnished to a beneficiary with AKI in a hospital outpatient setting. Therefore, we proposed to pay for these items and services separately when they are furnished to beneficiaries with AKI receiving dialysis in ESRD facilities. We proposed to codify this policy at 42 CFR 413.374(b).
The comments and our responses to the comments for these proposals are set forth below.
The commenters cautioned CMS that when analyzing historic utilization that the data may not be representative of the actual prevalence of AKI patients who require dialysis. A dialysis industry association urged CMS to closely track the utilization of items and services that patients with AKI dialysis receive that are in the bundle because the utilization could be higher.
A dialysis industry organization supported CMS' decision not to modify payment until there is more experience with these patients in the ESRD facility setting. Another dialysis industry organization concurred with CMS' intent to monitor separately billable services for appropriate utilization and urges CMS to strike a careful balance between monitoring and recognizing that utilization will be higher. A different dialysis industry organization commented that CMS should reaffirm the distinct needs of AKI patients and be supportive of flexibility for physicians to determine AKI versus ESRD classification, frequency of treatment, and the types of services provided.
We acknowledge the commenters' concerns regarding AKI patients' more frequent use of renal dialysis services when compared to ESRD beneficiaries. We encourage the reporting of all items and services furnished to beneficiaries with AKI. We also expect ESRD facilities to continue to report all services that are furnished to ESRD beneficiaries. We plan to monitor the utilization of these items and services to support any necessary changes in future rulemaking.
With regard to the flexibility for physicians to determine when an AKI patient has regained kidney function, or whether the transition must be made to ESRD treatment, we agree that this is a medical decision that should be supported by lab tests and a dialysis scheduling protocol, including withdrawing dialysis to determine the extent of recovery of renal function. The goal of AKI should be to have the kidneys return to normal functioning.
Generally, we would pay for only one treatment per day across all settings. However, similar to the policy applied under the ESRD PPS for treatments for patients with ESRD, in the interest of fairness and in accordance with Chapter 8, section 10.2 of the Medicare Claims Processing Manual, if a dialysis treatment is started, that is, a patient is connected to the machine and a dialyzer and blood lines are used, but the treatment is not completed for some unforeseen, but valid reason, for example, a medical emergency when the patient must be rushed to an emergency room, both the ESRD facility and the hospital would be paid. We consider this to be a rare occurrence that must be fully documented to the A/B MAC's satisfaction.
We do not expect that beneficiaries with AKI will receive dialysis in their homes due to the duration of treatment and the unique needs of AKI. Specifically, it is our understanding that these patients require supervision by qualified staff during their dialysis and close monitoring through laboratory tests to ensure that they are receiving the necessary care to improve their condition and get off of dialysis. Therefore, we did not propose to extend the home dialysis benefit to beneficiaries with AKI.
Section 1881(b)(14)(B) of the Act specifically excludes vaccines covered under section 1861(s)(10) of the Act from the ESRD PPS. However, ESRD facilities are identified as an entity that can bill Medicare for vaccines and their administration. Therefore, we proposed to allow ESRD facilities to furnish vaccines to beneficiaries with AKI and bill Medicare in accordance with billing requirements in the Medicare Claims Processing Manual (Pub. 100-04, Chapter 18 Preventive and Screening Services, section 10.2 which is located on the CMS Web site:
The comments and our responses to the comments for these proposals are set forth below.
With regard to the commenter's concern regarding modalities, we agree with commenters that individuals with AKI should have the ability, if they are candidates, for other modalities of dialysis while they are in the facility. Therefore, in response to commenters we will apply our policy of payment for AKI dialysis to both in-center PD and HD. We are finalizing payment for both of these dialysis modalities furnished to individuals with AKI in a week, including peritoneal dialysis when clinically appropriate, when the dialysis is furnished in the ESRD facility. Further discussion regarding home dialysis is below.
With regard to the commenter's suggestion to clarify the ESRD policies that do not apply to AKI, as we stated below, we anticipate that most of the policies laid out in Chapter 8 of the Medicare Claims Processing Manual will also apply to claims for dialysis furnished to individuals with AKI. In the timeframe available for the implementation of the payment for dialysis furnished to individuals with AKI, we believe that it is prudent to move into CY 2017 with payment policies that ESRD facilities are accustomed to following. As we monitor utilization of renal dialysis services and other items and services that the ESRD facilities furnish to individuals with AKI, we plan to engage the dialysis community to determine through rulemaking the continuation or discontinuation of certain policies which are or are not applicable to this population.
Because we are aware of the unique acute medical needs of the AKI population, we plan to closely monitor utilization of dialysis and all separately billable items and services furnished to individuals with AKI by ESRD facilities. For example, stakeholders have stated that beneficiaries with AKI will require frequent labs to monitor renal function or they will be at risk for developing chronic renal failure. Another recurrent concern is the flexibility necessary in providing dialysis sessions to beneficiaries with AKI. Stakeholders have told us that these patients may need frequent dialysis, but will also require days with no dialysis to test for kidney recovery. Consequently, we will closely monitor utilization of dialysis treatments and the drugs, labs and services provided to these beneficiaries.
We met with both physician and provider associations with regard to the care of patients with AKI. Both have expressed concerns that physician oversight will be limited for these beneficiaries, based on current operational models used by ESRD facilities. They encouraged CMS to support close monitoring of this patient population, particularly with regard to lab values, in the interest of preventing these patients from becoming ESRD patients. A close patient-physician relationship is critical for the successful outcome of the AKI patient.
The comments and our responses to the comments for this approach are set forth below.
The ESRD Conditions for Coverage (CfCs) at 42 CFR part 494 are health and safety standards that all Medicare-participating dialysis facilities must meet. These standards set baseline requirements for patient safety, infection control, care planning, staff qualifications, record keeping, and other
We did not propose changes to the CfCs specific to AKI, but did request comment from the dialysis community as to whether revisions to the CfCs might be appropriate for addressing treatment of AKI in ESRD facilities. We received 11 timely comments addressing this issue and thank the commenters for their input. While we are not formally responding to the comments at this time, the comments are summarized (with some clarification on our part), below.
All commenters agreed that we do not need to revise the ESRD CfCs to address AKI at this time. About half of the commenters recommended that we not revise the CfCs to directly address AKI at all, while the remaining commenters suggested we consider revisions to requirements addressing the comprehensive patient assessment, care planning, modality options, and transplantation. A few commenters recommended that we not revise the ESRD CfCs to address AKI because AKI and ESRD are different diseases. We understand the reasoning behind this statement but wish to clarify that the ESRD CfCs apply to ESRD
We thank the commenters, and will consider their comments for future rulemaking and regulatory guidance.
For payment purposes, claims for beneficiaries with AKI would be identified through a specific condition code, an AKI diagnosis, an appropriate revenue code, and an appropriate Common Procedural Terminology code. These billing requirements would serve to verify that a patient has AKI and differentiate claims for AKI from claims for patients with ESRD. ESRD facilities are expected to report all items and services furnished to individuals with AKI and include comorbidity diagnoses on their claims for monitoring purposes. We anticipate that with exceptions for separately billable items and services, most of the claims policies laid out in Chapter 8 of the Medicare Claims Processing Manual will also apply to claims for dialysis furnished to AKI beneficiaries. All billing requirements will be implemented and furnished through sub-regulatory guidance.
The comments and our responses to the comments for these proposals are set forth below.
In future years, we anticipate announcing the AKI payment rate in the annual ESRD PPS rule or in a
The comments and our responses to the comments for this proposal are set forth below.
Section 1881(h) of the Act requires the Secretary to establish an End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP) by (1) selecting measures; (2) establishing the performance standards that apply to the individual measures; (3) specifying a performance period with respect to a year; (4) developing a methodology for assessing the total performance of each facility based on the performance standards with respect to the measures for a performance period; and (5) applying an appropriate payment reduction to facilities that do not meet or exceed the established Total Performance Score (TPS). This final rule discusses each of these elements and our policies for their application to the ESRD QIP.
The proposed rule, titled “End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care Model” (81 FR 42802 through 42880), was published in the
In that proposed rule, for the ESRD QIP, we proposed updates to the ESRD QIP, including updates for the PY 2018 through PY 2020 programs. We received approximately 50 public comments on our proposals related to the ESRD QIP, including comments from large dialysis organizations, ESRD facilities; national renal groups, nephrologists, patient organizations, patients and care partners, manufacturers, health care systems; nurses, and other stakeholders.
In this final rule, we provide a summary of each proposed provision, a summary of the public comments received and our responses to them, and the policies we are finalizing for the ESRD QIP. Comments related to the paperwork burden are addressed in the “Collection of Information Requirements” section in this final rule. Comments related to the impact analysis are addressed in the “Economic Analyses” section in this final rule.
We received comments about general policies and principles of the ESRD QIP. The comments and our responses are set forth below.
Many commenters raised particular concerns about the lack of measures in the QIP that adequately address the needs of the pediatric population or of home hemodialysis patients. They argued that the current measurement criteria do not take their unique needs into consideration. Commenters asked CMS to ensure that the reporting structure is viable for all providers, whether they service patients in-center or at home. Many of the smaller facilities enter data manually into CROWNWeb, and commenters argued that given the current structure of the QIP, many pediatric facilities in particular are unable to participate. They recommended that CMS focus its attention on aligning quality metrics and value-based programs with the goal of achieving a high quality of care for pediatric patients. One commenter argued that it is counter-productive to subject providers who care for unique populations to penalties for not achieving results which are unrealistic in their populations.
One objective measure we can examine is the improvement of performance standards over time. Table 2 below shows that as the ESRD QIP has refined its measure set and as facilities have gained experience with the measures included in the program, performance standards have generally continued to rise. We view this as evidence that facility performance is objectively improving. It remains difficult to disentangle these results from the impact of the ESRD QIP policies or those of other policies and developments in the field, but they show a steady rise in the quality of care received by patients with ESRD.
Regarding commenter's concern that facilities may be forced to close based upon the ESRD QIP's payment reductions, we have reviewed data on facility closures from 2008 through 2013 and we have seen a steady decrease in the number of facilities that have closed from 80 in 2010 to 56 in 2013. We recognize that the absolute number rose slightly from 45 in 2012 to 56 in 2013. However these numbers must be looked at in context. As a percentage of the total number of dialysis facilities nationwide, the number of facilities closing each year is not significant. Additionally, facility closures cannot be definitively attributed to any single factor. The ESRD QIP policies may play a small role in these numbers, but many other factors, both within and outside of healthcare, have an impact. Table 3 below shows the number of facilities closed from 2008 through 2013.
In developing this core set of measures, commenters urged CMS to adopt a set of minimum global exclusions that would be automatically applied to all measures. Specifically, they recommended the following exclusions: (1) Beneficiaries who die within the applicable month; (2) Beneficiaries who receive fewer than 7 treatments in a month; (3) Beneficiaries receiving home dialysis therapy who miss their in-center appointments when there is a documented good faith effort to have them participate in such a visit during the applicable month; (4) Transient dialysis patients; (5) Pediatric patients (unless the measure is specific to pediatric patients); and (6) Kidney transplant recipients with a functioning graft. Additionally, commenter asked that CMS clarify that beneficiaries must have treatment for at least 60 days to be assigned to a facility. One commenter added that CMS should particularly consider the needs of small facilities, pediatric patients, and patients who have received a transplant when developing exclusions which would apply across the board.
As we stated in the CY 2015 ESRD PPS Final Rule (79 FR 66164), we considered applying these six global exclusion criteria in response to comments on the CY 2014 ESRD PPS proposed rule (78 FR 72192). We agree with commenters that exclusion criteria for the ESRD QIP measures should be consistent, where feasible. We further believe, however, that exclusions also need to take into account the population to which a measure applies and the settings for which the measures were developed (for example, in-center hemodialysis as opposed to home hemodialysis). As stated in previous rules, we will continue to look for ways to align exclusion criteria for measures in the ESRD QIP, as long as there is evidence to support such consistency.
In the CY 2016 ESRD PPS Final Rule, we revised the calculation of the Small Facility Adjuster (SFA) (80 FR 69039). In that rule we proposed to correct our description of the SFA for payment year (PY) 2017 and future years. Our original proposal pegged the SFA to the national mean, such that small facilities scoring below the national mean would receive an adjustment, but small facilities scoring above the national mean would not. Several commenters supported the overall objectives of the proposed SFA modification but were concerned that too few facilities would receive an adjustment under our proposed methodology. They recommended that rather than pegging the SFA to the national mean, we peg the SFA to the benchmark, which is the 90th percentile of national facility performance on a measure, such that facilities scoring below the benchmark would receive an adjustment, but those scoring above the benchmark would not. In the process of updating the finalized policy to reflect public comment, we inadvertently neglected to update this sentence from our statement of finalized policy: “For the standardized ratio measures, such as the Standardized Readmission Ratio (SRR) and Standardized Transfusion Ratio (STrR) clinical measures, the national mean measure rate (that is,
Setting the ratio measures at the national mean in the SFA equation would have been inconsistent with our desired policy position and would have been unresponsive to the commenter's point. It was also inconsistent with another part of our statement on the finalized SFA methodology and was more punitive for facilities because it did not provide an adjustment for a number of small facilities that may have been adversely affected by a small number of outlier patients. Therefore, in this year's rule making we proposed to correct the description of the SFA methodology such that, for the standardized ratio measures such as the SRR and STrR clinical measures,
We sought comments on this proposal. The comments and our responses to comments are set forth below.
During the measure maintenance process at National Quality Forum (NQF), two substantive changes were made to the Hypercalcemia clinical measure. First, plasma was added as an acceptable substrate in addition to serum calcium. Second, the denominator definition changed such that it now includes patients regardless of whether any serum calcium values were reported at the facility during the 3-month study period. Functionally, this means that a greater number of patient-months will be included in this measure, because patient-months will not be excluded from the measure calculations solely because a facility reports no calcium data for that patient during the entire 3-month study period.
We proposed to update the measure's technical specifications for PY 2018 and future years to include these two substantive changes to the Hypercalcemia clinical measure included in the ESRD QIP. These changes will positively impact data completeness in the ESRD QIP because facilities' blood tests typically use plasma calcium rather than serum calcium. Including patients with unreported calcium values in the measure calculations will encourage more complete reporting of this data. Additionally, these changes will ensure that the measure aligns with the NQF-endorsed measure and can continue to satisfy the requirements of the Protecting Access to Medicare Act of 2014 (PAMA), which requires that the ESRD QIP include in its measure set measures (outcomes-based, to the extent feasible), that are specific to the conditions treated with oral-only drugs.
We sought comments on this proposal. The comments and our responses are set forth below.
Because we are now finalizing the changes proposed to the Hypercalcemia Clinical Measure for PY 2019, we have provided updated Technical Specifications for PY 2018 at
Commenters also asserted that the measure provides no value to the patient and does not relate to the provision of quality care. Despite these concerns, they expressed an understanding that maintaining this measure in the ESRD QIP measure set meets the statutory requirements of PAMA, and encouraged CMS to work with the kidney care community to find replacement measures. They added that CMS should continue to track hypercalcemia, but stated that linking hypercalcemia to specific medications without including the influence of active Vitamin D is problematic and unlikely to produce reliable data. In the interim, commenters expressed support for the proposed changes to the measure to ensure that the measure continues to satisfy NQF recommendations, but urged CMS to continue monitoring the Food and Drug Administration's (FDA's) approach to new injectables because that may require CMS to reconsider its approach.
We recognize that the Hypercalcemia measure is not a comprehensive measure of all oral-only medications, but limitations in available evidence have prevented us from developing measures that might address oral-only medications more broadly used in the ESRD dialysis population. We will continue to work with the community to develop more comprehensively applicable measures that meet these requirements. Three TEPs have been convened in 2006, 2010, and 2013 to address the topic of mineral bone disease measures, but the limited clinical evidence available has prevented those panels from recommending any measures that identify elevated levels of parathyroid hormone (PTH) or phosphorus. We have consulted with the dialysis community on this matter and will continue to do so, but we are unaware of any other specified and NQF-endorsed measure that would meet the requirements in PAMA. As evidence evolves to support more comprehensive measures of conditions treated by and these measures earn consensus endorsement, we agree that it will be appropriate to carefully consider the role of the Hypercalcemia measure in the ESRD QIP.
The 2013 Mineral and Bone Disorder TEP recognized the current limited evidence supporting development of a new MBD measure. They repeatedly raised the issue of the overall lack of evidence that was available due to the lack of randomized clinical trials that exist in order to inform recommendations for proposed measures, and meet the criterion of scientific acceptability. The TEP did discuss the strength of evidence regarding PTH as a risk factor in light of recent randomized trials including EVOLVE (2012) and the ADVANCE study (2011).
EVOLVE Trial Investigators, Chertow GM, Block GA, et al. “Effect of cinacalcet on cardiovascular disease in patients undergoing dialysis.” The New England journal of medicine (2012) 367:2482-94. PMID: 23121374.
The 2013 TEP members agreed that the combination of laboratory values (PTH with calcium and phosphorus) may be more predictive of mortality, but since each lab value changes individually, it would be very difficult to make a recommendation based on a combination. It should also be noted that, the kidney care community would more readily support such a composite measure if each constituent measure were NQF endorsed. Previously one PTH measure, and two phosphorous measures were submitted to NQF (in 2010). These measures, respectively, were not endorsed due to the lack of evidence supporting a PTH target or range, and similarly lack of evidence to support a target for phosphorous. The suggested composite measure may be conceptually satisfying, but we are concerned that we lack sufficient evidence to justify implementing such a measure at this time.
We first adopted the National Healthcare Safety Network (NHSN) Dialysis Event Reporting Measure for the PY 2014 ESRD QIP. For that program year, we required facilities to (1) enroll in the NHSN and complete any training required by the Centers for Disease Control and Prevention (CDC); and (2) submit 3 or more consecutive months of dialysis event data to the NHSN (76 FR 70268 through 69). For PY 2015, we retained the requirement for facilities to enroll in the NHSN and complete any training required by the CDC, but expanded the reporting period to require facilities to report a full 12 months of dialysis event data (77 FR 67481 through 84). Beginning with PY 2016, we replaced the NHSN Dialysis Event Reporting Measure with the clinical version of the measure (78 FR 72204 through 07). As a result, facilities were scored for purposes of the ESRD QIP based on how many dialysis events they reported to the NHSN in accordance with the NHSN protocol. We introduced the clinical version of the measure because we believed that the measure would hold facilities accountable for monitoring and preventing infections in the ESRD population. We continue to believe it is vitally important to hold facilities accountable for their actual clinical performance on this measure.
Since we introduced the NHSN Bloodstream Infection (BSI) Clinical Measure into the ESRD QIP, some stakeholders have expressed significant concerns about two distinct types of accidental or intentional under-reporting. First, these stakeholders believe that many facilities do not consistently report monthly dialysis event data for the full 12-month performance period. Second, these stakeholders believe that even with respect to the facilities that report monthly dialysis event data, many of those facilities do not consistently report all of the dialysis events that they should be reporting. (80 FR 69048). These public comments, as well as our thorough review of data reported for the PY 2015 NHSN Dialysis Event Reporting Measure and results from the PY 2014 NHSN data validation feasibility study, suggest that as many as 60 to80 percent of dialysis events are under-reported.
We believe that there are delicate tradeoffs associated with incentivizing facilities to both report monthly dialysis event data and to accurately report such data. On the one hand, if we incentivize facilities to report monthly dialysis event data but do not hold them accountable for their performance, we believe that facilities will be more likely to accurately report all dialysis events. Complete and accurate reporting is critical to maintaining the integrity of the NHSN surveillance system, enables facilities to implement their own quality improvement initiatives, and enables the CDC to design and disseminate prevention strategies. Nevertheless, incentivizing full and accurate reporting without financial consequences for poor performance will not necessarily improve patient safety. On the other hand, if we incentivize facilities to achieve high clinical performance scores without also incentivizing them to accurately report monthly dialysis event data, we believe that facilities will be less likely to report complete and accurate monthly data, which could diminish the integrity of the NHSN surveillance system and the quality improvement efforts that it supports. Maintaining an incentive structure along these lines increases the financial consequences for not achieving high clinical scores, but jeopardizes the accuracy and completeness of the dialysis event data upon which those scores are based.
In light of these considerations, we believe that the best way to strike the proper balance between these competing interests is to propose to reintroduce the expanded NHSN Dialysis Event Reporting Measure, beginning with PY 2019, and to include both this measure and the NHSN BSI Clinical Measure in the ESRD QIP measure set.
In combination with other programmatic features described in the proposed rule (see sections IV.C.2. and IV.C.8. of the proposed rule (81 FR 42824)), we believe this reporting measure will bolster incentives for facilities to report complete and accurate data to NHSN, while the clinical measure will preserve incentives to reduce the number of dialysis events. We believe that including both of these measures in the ESRD QIP measure set will ensure that we hold facilities accountable for the frequency with which they report data to the NHSN and will address validation concerns related to the two distinct types of under-reporting of data, described above.
Beginning with PY 2019, we proposed that facilities must enroll in NHSN and complete any training required by the CDC related to reporting dialysis events via NHSN, and that they must report monthly dialysis event data on a quarterly basis to the NHSN. We also proposed that each quarter's data would be due 3 months after the end of the quarter. For example, data from January 1 through March 31, 2017 would need to be submitted to NHSN by June 30, 2017; data from April 1 through June 30, 2017 would need to be submitted by September 30, 2017; data from July 1 through September 30, 2017 would need to be submitted by December 31, 2017;
Section 1881(h)(2)(B)(i) of the Act requires that, unless the exception set forth in section 1881(h)(2)(B)(ii) of the Act applies, the measures specified for the ESRD QIP under section 1881(h)(2)(A)(iii) of the Act must have been endorsed by the entity with a contract under section 1890(a) of the Act (which is currently NQF). Under the exception set forth in 1881(h)(2)(B)(ii) of the Act, in the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the entity with a contract under section 1890(a) of the Act, the Secretary may specify a measure that is not so endorsed so long as due consideration is given to measures that have been endorsed or adopted by a consensus organization identified by the Secretary. The proposed NHSN Dialysis Event Reporting Measure is not endorsed by the NQF, but for the reasons explained above, we believe that it is appropriate to assess facilities solely based on whether they actually report full and accurate monthly dialysis event data to the NHSN. Although we recognize that the NHSN BSI Clinical Measure is currently included in the ESRD QIP measure set and that this measure and the proposed NHSN Dialysis Event Reporting Measure would be calculated using the same set of data, the two measures assess different outcomes. We believe that including both of these measures in the ESRD QIP measure set will collectively support our efforts to ensure that facilities report, and are scored based on, complete and accurate dialysis event data.
We sought comments on this proposal. The comments and our responses are set forth below.
The NHSN BSI measure has been endorsed by the National Quality Forum (NQF). The quantitative centerpiece of the NQF-endorsed NHSN Dialysis Event Bloodstream Infection Measure is the Standardized Infection Ratio (SIR), which is the ratio of observed to predicted events. Because the SIR has withstood scrutiny from NQF, which explicitly considered the measure's reliability, we continue to believe that it is reliable enough to remain in the ESRD QIP measure set.
We recognize that there are shortfalls in BSI ascertainment for purposes of reporting and that more needs to be done to improve the quality and completeness of data used in the NHSN BSI measure. Nevertheless, the measure itself remains an important tool for assessing the quality of care and closing performance gaps when and where they are identified, and there is no other measure available that would serve this purpose. We believe that further improvements in the reliability of NSHN data can be achieved through more complete communications between hospitals and dialysis facilities of relevant measure data, in particular the results of diagnostic microbiology testing by hospitals that are indicative of bloodstream infections in dialysis patients. We also believe that more robust validation of measure data, such as the validation approach we are finalizing, offer additional safeguards against incomplete case finding and shortcomings in measure data. Additionally, the CDC has encouraged dialysis providers, especially large dialysis organizations, to perform a validation of their own data. The CDC has provided a validation toolkit, available for any facility to use on its own. The goal of the validation, whether performed internally or by an external observer, is to improve the quality of the data. Taking all these considerations into account, we believe that on balance the ESRD QIP and patients' interests are best served by retaining the NHSN BSI measure in the ESRD QIP measure set.
With respect to the NHSN Dialysis Event Reporting measure, we proposed to score facilities with a CCN Open Date on or before January 1, 2017. Using the methodology described below, we proposed to assign the following scores for reporting different quantities of data:
We selected these scores for the following reasons: First, due to the seasonal variability of bloodstream infection rates, we want to incentivize facilities to report the full 12 months of data and reward reporting consistency over the course of the entire performance period. We therefore proposed that facilities will receive 10 points for submitting 12 months of data. Second, we recognized, however, that from the perspective of national prevention strategies and internal quality improvement initiatives, there is still some value in collecting fewer than 12 months of data from facilities. We also stated that we would need at least 6 months of data in order to calculate reliable scores on the NHSN BSI Clinical Measure. For these reasons, we proposed that facilities will receive 2 points for reporting between 6 and 11 months of dialysis event data. Finally, in consultation with the CDC, we have determined that NHSN BSI Clinical Measure rates are not reliable when they are calculated using fewer than 6 months of data. For that reason, we proposed that a facility will receive 0 points on the NHSN Dialysis Event Reporting Measure if it reports fewer than 6 months of data.
The proposed scoring methodology for the NHSN Dialysis Event Reporting Measure differs slightly from what we finalized for PY 2015. For that year of the program, facilities were awarded 0 points for reporting fewer than 6 months of data, 5 points for reporting 6 consecutive months, and 10 points for reporting all 12 months of data. We believe that it is appropriate to reduce the number of points facilities receive for reporting 6-11 months of data from 5 to 2 because by PY 2019, facilities will have had 3 more years of experience reporting data to NHSN than they had for PY 2015.
We sought comments on this proposal. The comments and our responses are set forth below.
Beginning with PY 2019, we proposed to create a new NHSN BSI Measure Topic. We proposed that this measure topic would consist of the following two measures:
(i) NHSN Bloodstream Infection (BSI) in Hemodialysis Patients, a clinical measure;
(ii) NHSN Dialysis Event Reporting Measure.
We sought comments on this proposal. The comments and our responses are set forth below.
In a small study, CDC compared the NHSN denominator to various denominator measures including the last 2 days of the month and the entire month using electronically captured data and found that the first two working days was a generally good estimate of the entire month denominator.
Specifically, the results revealed a strong correlation between monthly total denominator and NHSN denominator and between the NHSN denominator and the other denominator methods [p< 0.0001].
We note that although a “growing clinic” might have an NHSN denominator that is low in one month (if there is a drastic increase during that month), the denominator should be a good estimator of the number of patients at the facility for all subsequent months. If the growth is more gradual, then the NHSN denominator is still a relatively good estimator of the month census. The only way this would not be the case is if census fluctuated drastically within each month so that the first 2 days were always somehow different than the rest of the month (for example, patients always added in the middle of the month and then removed before the start of the next month). We have not encountered a systematically occurring example of this type of phenomenon.
We currently use two domains in the ESRD QIP for purposes of scoring. The first domain, termed the Clinical Measure Domain, is defined as an aggregated metric of facility performance on the clinical measures and measure topics in the ESRD QIP, and we use subdomains within the Clinical Measure Domain for the purposes of calculating the Clinical Measure Domain score (79 FR 66213). Second is a Reporting Measure Domain, in which scores on reporting measures are weighted equally (79 FR 66218 through 66219).
In section IV.C.2 of the proposed rule (81 FR 42825), we described the NHSN BSI Measure Topic. We believe that this measure topic, consisting of both the NHSN Dialysis Event Reporting Measure and the NHSN BSI Clinical Measure, is fundamentally different from the other measures and measure topics included in the ESRD QIP's measure set. The two measures included in this measure topic are inextricably linked because data from the reporting measure is used to calculate the clinical measure. No other reporting measures currently included in the ESRD QIP's measure set are used for this purpose. Placing these two measures together in a single measure topic to which we can assign a single measure topic score, creates the important linkage between the two measures and balances out the competing incentives involved: Incentivizing complete and accurate reporting of data to NHSN while also incentivizing facilities to achieve high clinical scores on the clinical measure. Therefore, it does not appropriately belong in either the Reporting Measure Domain or the Clinical Measure Domain.
Because of these fundamental differences, we proposed to remove the Safety Subdomain from the Clinical Measure Domain for PY 2019 and future payment years. We proposed that the Safety Subdomain will instead be a new, third Domain, separate from and in addition to the existing Clinical and Reporting Measure Domains. Additionally, we proposed that facilities will receive a Safety Measure Domain score in addition to their Reporting Measure Domain and Clinical Measure Domain scores. We describe our proposed scoring methodology more fully in section IV.C.6 of our proposed rule (81 FR 42826), and note that these three Domain scores will be combined and weighted to produce a Total Performance Score (TPS) for each facility.
We sought comments on these proposals. The comments and our responses are set forth below.
We proposed to assign significant weight to the NHSN Dialysis Event Reporting Measure in the overall NHSN BSI Measure Topic score. However, our proposed weighting scheme also reflects our goal to incentivize strong performance on the clinical measure. For these reasons, we proposed that the NHSN Dialysis Event Reporting Measure be weighted at 40 percent of the measure topic score and the NHSN BSI Clinical Measure be weighted at 60 percent of the measure topic score. The formula below depicts how the NHSN BSI Measure Topic would be scored.
We sought comment on this proposal. The comments and our responses are set forth below.
In the calendar year (CY) 2016 ESRD PPS final rule, we finalized that for PY 2019, the performance standards, achievement thresholds, and benchmarks for the clinical measures would be set at the 50th, 15th and 90th percentile, respectively, of national performance in CY 2015, because this will give us enough time to calculate and assign numerical values to the proposed performance standards for the PY 2019 program prior to the beginning of the performance period. (80 FR 69060). At the time the proposed rule was published, we did not have the necessary data to assign numerical values to the proposed performance standards, achievement thresholds, and benchmarks because we did not yet have complete data from CY 2015. Nevertheless, we were able to estimate these numerical values based on the most recent data available at the time. For the Vascular Access Type, Hypercalcemia, NHSN BSI and ICH CAHPS clinical measures, this data came from the period of January through December 2015. For the SRR and STrR clinical measures, this data came from the period of January through December 2014. In Table 5, we provided the estimated numerical values for all of the finalized PY 2019 ESRD QIP clinical measures.
In previous rulemaking, we have finalized policies to the effect that if final numerical values for the performance standard, achievement threshold, and/or benchmark were worse than they were for that measure in the previous year of the ESRD QIP, then we would substitute the previous year's performance standard,
We sought comments on this proposal. The comments and our responses are set forth below.
As discussed in section IV.C.3 of the proposed rule (81 FR 42825), we proposed to remove the Safety Subdomain from the Clinical Measure Domain and establish it as a third domain alongside the Clinical Measure and Reporting Measure Domains for the purposes of scoring facilities and determining Total Performance Scores (TPSs).
In light of stakeholder comments we have received about the prevalence of under-reporting for the NHSN BSI Clinical Measure, as well as the tradeoffs (discussed more fully in section IV.C.1.a. of the proposed rule (81 FR 42823) between our desire to maintain strong incentives for facilities to report bloodstream infections and to prevent those infections, and because the Safety Domain is comprised of a single measure topic, we believe it is necessary to reduce the weight of the Safety Measure Domain as a percentage of the TPS. However, we believe it is important to maintain as much consistency as possible in the ESRD QIP scoring methodology. Therefore, we proposed to gradually reduce the weight of the Safety Measure Domain to 15 percent of the TPS in PY 2019, and then reduce it further in PY 2020, as proposed below. We further proposed that the Clinical Measure Domain will be weighted at 75 percent of the TPS, and the Reporting Measure Domain will continue to be weighted at 10 percent of the TPS because we do not want to diminish the incentives to report data on the reporting measures.
In the CY 2015 ESRD PPS final rule, we finalized the criteria we will use to
With respect to criterion 3, one of our top priorities for improving the quality of care furnished to ESRD patients includes increasing the number and significance of both outcome and patient experience of care measures because these measures track important patient outcomes, instead of focusing on the implementation and achievement of clinical processes that may not result in improved health for patients.
In light of the proposed addition of the Safety Measure Domain as well as the policy priorities discussed above, we proposed to change the Clinical Measure Domain weighting for the PY 2019 ESRD QIP. Specifically, we proposed to increase the weight of the Vascular Access Type, Dialysis Adequacy and Hypercalcemia measures by 1 percentage point each in the Clinical Measure Domain. This will result in a minor reduction of the weight that each of these measures receives as a percentage of the TPS, which is consistent with our policy to assign greater weight to outcome and experience of care measures. We also proposed to apportion six percent of the Clinical Measure Domain to the standardized readmission ratio (SRR) and In-center hemodialysis consumer assessment of healthcare providers and systems (ICH CAHPS) measures, and to apportion the remaining 5 percent to the standardized transfusion ratio (STrR) measure. We believe this is appropriate because it distributes points as equally as possible among the outcome and experience of care measures, with a slight preference for SRR and ICH CAHPS because facilities will have had more experience with these measures than they will have had with STrR.
For the reasons discussed above, we proposed to use the following weighting system in Table 7 below, for calculating a facility's Clinical Measure Domain score for PY 2019. For comparison, in Table 8, we have also provided the Measure Weights we originally finalized for PY 2019 in the CY 2016 ESRD PPS Final Rule (80 FR 69063).
In the CY 2016 ESRD PPS Final Rule, we finalized a requirement that, to be eligible to receive a TPS, a facility had to be eligible for at least one reporting measure and at least one clinical measure (80 FR 69064). With the proposed addition of the Safety Measure Domain for PY 2019, we proposed a change to this policy. Specifically, for PY 2019, we proposed that to be eligible to receive a TPS, a facility must be eligible for at least one measure in the Clinical Measure Domain and at least one measure in the Reporting Measure Domain. As such, facilities do not need to receive a score on a measure in the Safety Measure Domain in order to be eligible to receive a TPS. The NHSN BSI Clinical Measure and the NHSN Dialysis Event Reporting Measure have the same eligibility requirements (specifically they require that a facility treated at least 11 eligible patients during the performance period). We proposed this change in policy to avoid a situation in which a facility is eligible to receive a TPS when it only receives a score for a single measure topic. We did not propose any changes to the policy that a facility's TPS will be rounded to the nearest integer, with half of an integer being rounded up.
We sought comments on these proposals. The comments and our responses for these proposals are set forth below.
The weights we are finalizing appear in Table 9, below:
In this section, we provide examples to illustrate the proposed scoring methodology for PY 2019. Figures 1 through 4 illustrate how to calculate the Clinical Measure Domain score, the Reporting Measure Domain score, the Safety Measure Domain score, and the TPS. Figure 5 illustrates the full proposed scoring methodology for PY 2019. Note that for this example, Facility A, a hypothetical facility, has performed very well.
Figure 1 illustrates the methodology used to calculate the Clinical Measure Domain score for Facility A.
Figure 2 illustrates the general methodology for calculating the Reporting Measure Domain score for Facility A.
Figure 3 illustrates the methodology used for calculating the Safety Measure Domain score for Facility A.
Figure 4 illustrates the methodology used to calculate the TPS for Facility A.
Figure 5 illustrates the full scoring methodology for PY 2019.
Section 1881(h)(3)(A)(ii) of the Act requires the Secretary to ensure that the application of the ESRD QIP scoring methodology results in an appropriate distribution of payment reductions across facilities, such that facilities achieving the lowest TPSs receive the largest payment reductions. In the CY 2016 ESRD PPS final rule, we finalized our proposal for calculating the minimum TPS for PY 2019 and future payment years (80 FR 69067). Under our current policy, a facility will not receive a payment reduction if it achieves a minimum TPS that is equal to or greater than the total of the points it would have received if: (i) It performs at the performance standard for each clinical measure; and (ii) it receives the number of points for each reporting measure that corresponds to the 50th percentile of facility performance on each of the PY 2017 reporting measures (80 FR 69067).
We were unable to calculate a minimum TPS for PY 2019 in the CY 2016 ESRD PPS final rule because we were not yet able to calculate the performance standards for each of the clinical measures. We therefore stated that we would publish the minimum TPS for the PY 2019 ESRD QIP in the CY 2017 ESRD PPS final rule (80 FR 69068).
Based on the estimated performance standards listed above, we estimated that a facility must meet or exceed a minimum TPS of 59 for PY 2019. For all of the clinical measures except the SRR and STrR, these data come from CY 2015. The data for the SRR and STrR clinical measures come from CY 2014 Medicare claims. For the ICH CAHPS clinical measure, we set the performance standard to zero for the purposes of determining this minimum TPS, because we are not able to establish a numerical value for the performance standard through the rulemaking process before the beginning of the PY 2019 performance period. We proposed that a facility failing to meet the minimum TPS, as established in the CY 2017 ESRD PPS final rule, will receive a payment reduction based on the estimated TPS ranges indicated in Table 10.
We sought comments on these proposals. The comments and our responses are set forth below.
One of the critical elements of the ESRD QIP's success is ensuring that the data submitted to calculate measure scores and TPSs are accurate. We began a pilot data validation program in CY 2013 for the ESRD QIP, and procured the services of a data validation contractor that was tasked with validating a national sample of facilities' records as reported to Consolidated Renal Operations in a Web-Enabled Network (CROWNWeb). For validation of CY 2014 data, our first priority was to develop a methodology for validating data submitted to CROWNWeb under the pilot data validation program. That methodology was fully developed and adopted through the rulemaking process. For the PY 2016 ESRD QIP (78 FR 72223 through 72224), we finalized a requirement to sample approximately 10 records from 300 randomly selected facilities; these facilities had 60 days to comply once they received requests for records. We continued this pilot for the PY 2017 and PY 2018 ESRD QIP, and proposed to continue doing so for the PY 2019 ESRD QIP. Under this continued validation study, we will sample the same number of records (approximately 10 per facility) from the same number of facilities (that is, 300) during CY 2017. If a facility is randomly selected to participate in the pilot validation study but does not provide us with the requisite medical records within 60 calendar days of receiving a request, then we propose to deduct 10 points from the facility's TPS. Once we have developed and adopted a methodology for validating the CROWNWeb data, we intend to consider whether payment reductions under the ESRD QIP should be based, in part, on whether a facility has met our standards for data validation.
In the CY 2015 ESRD PPS final rule, we also finalized that there will be a feasibility study for validating data reported to the Centers for Disease Control and Prevention (CDC's) National Healthcare Safety Network (NHSN) Dialysis Event Module for the NHSN BSI Clinical Measure. Healthcare-Acquired Infections (HAI) are relatively
For the PY 2019 ESRD QIP, we proposed to randomly select 35 facilities to participate in an NHSN dialysis event validation study by submitting 10 patient records covering two quarters of data reported in CY 2017. A CMS contractor will send these facilities requests for medical records for all patients with “candidate events” during the evaluation period;
We recognize that facilities have previously had 60 days to respond to these requests. However, in the process of implementing the pilot validation study for CY 2015 data, we recognized that the validation contractor did not have enough time to initiate requests, receive responses, validate data reported to NHSN, and generate a comprehensive validation report before the end of the contract cycle. Although facilities will have less time, the 30-day response requirement is consistent with validation studies conducted in the Hospital IQR Program, and we believe that 30 days is a reasonable amount of time for facilities to obtain and transmit the requisite medical records.
We sought comments on this proposal. The comments and our responses for these proposals are set forth below.
CDC agrees that there are substantial benefits that occur when health departments conduct on-site assessments of facility data and direct education of staff to improve surveillance practices. The CDC supports the suggestion of providing state health departments with funds to conduct data validation activities. Few states are currently funded via the CDC cooperative agreement (Epidemiology and Laboratory Capacity grant) to conduct external HAI data validation. These states have conducted data validation of patient safety modules that resulted in an improvement in states' understanding of gaps in HAI reporting, commonly made errors, improved partnerships and communication between state health departments and healthcare facilities.
With respect to the proposed reduced response time, one commenter argued that facilities often do not receive the faxed or written request for records or they are lost, leaving them with less time to respond to the request, and recommended that CMS instead email the requests to all of the NHSN users within each facility to ensure that the request is received. Another argued that 30 days is simply too short a period of time to ensure the request is received and can be completed. One commenter also added that providers often must obtain documentation from other healthcare providers in order to respond to the request and that 60 days is simply not enough time to receive the request, coordinate with other providers, and send in the required documentation. One commenter suggested that while the data validation study is ongoing, CMS should not reduce a facility's TPS since the purpose of the study, as commenter sees it, is to assess future policies to ensure the accuracy of the data submitted to NHSN.
With regards to the penalty for non-response, commenters urged CMS to eliminate the proposed 10-point reduction in a facility's TPS due to non-compliance with the NHSN Data Validation Study for two reasons. First, they argued that compliance with a data validation study is unrelated to the quality of care provided at a facility and therefore is inappropriate for inclusion in a facility's TPS. Second, they suggested that reducing a facility's TPS score confuses and misinforms patients, caregivers and families about the quality of care provided at a given facility.
We disagree with the comment about deducting points from a facility's TPS for noncompliance with the CROWNWeb and NHSN validation studies. As stated previously at (79 FR 66189), our policy to deduct points from a facility's TPS is consistent with section 1881(h)(3)(A)(i) of the Act, because it is part of our methodology for assessing the total performance of each provider of services and renal dialysis facility based on performance standards with respect to the measures selected. The main purpose of these studies is to assess whether facilities are reporting accurate data, and we have determined that review of medical records is integral to that determination.
We consider a quality measure for removal or replacement if: (1) Measure performance among the majority of ESRD facilities is so high and unvarying that meaningful distinctions in improvements or performance can no longer be made (in other words, the measure is topped-out); (2) performance or improvement on a measure does not result in better or the intended patient outcomes; (3) a measure no longer aligns with current clinical guidelines or practice; (4) a more broadly applicable (across settings, populations, or conditions) measure for the topic
Subsequent to the publication of the CY 2016 ESRD PPS final rule, we evaluated the finalized PY 2019 ESRD QIP measures that would be continued in PY 2020 against all of these criteria. We determined that none of these measures met criterion (1), (2), (3), (4), (5) or (6). As part of this evaluation for criterion one, we performed a statistical analysis of the PY 2019 measures to determine whether any measures were “topped out.” The full results of this analysis can be found at
As the information in Table 12 indicates, none of these clinical measures are currently topped-out in the ESRD QIP. Accordingly, we did not propose to remove any of these measures from the ESRD QIP for PY 2020 because they are topped out.
We consider the data sources we use to calculate our measures based on the reliability of the data, and we also try to use CROWNWeb data whenever possible. The Mineral Metabolism measure currently in the ESRD QIP measure set uses CROWNWeb data to determine how frequently facilities report serum phosphorus data, but it also uses Medicare claims data to exclude patients when they were treated at a facility fewer than seven times in a month. There is no evidence to suggest that the Mineral Metabolism reporting measure is leading to negative or unintended clinical consequences. However, we do not think it is optimal to use claims data to calculate the measure because that is inconsistent with our intention to increasingly use CROWNWeb as the data source for calculating measures in the ESRD QIP. There is also another available measure that can be calculated using only CROWNWeb data and that we believe is as reliable as the Mineral Metabolism Reporting Measure. The measure also excludes patients using criteria consistent with that used by other ESRD QIP measures. For these reasons, we proposed to remove the Mineral Metabolism Reporting Measure from the ESRD QIP measure set beginning with the PY 2020 program and to replace that measure with the proposed Serum Phosphorus Reporting measure, the specifications for which are described in section IV.D.2.c.i. of the proposed rule (81 FR 42838)
We sought comments on this proposal. The comments and our responses for these proposals are set forth below.
We previously finalized 12 measures in the CY 2016 ESRD PPS final rule for the PY 2019 ESRD QIP, and these measures are summarized in Table 13. In accordance with our policy to continue using measures unless we propose to remove or replace them, (77 FR 67477), we will continue to use 11 of these measures in the PY 2020 ESRD QIP. As noted above, we proposed to replace the Mineral Metabolism Reporting Measure with the Serum Phosphorus Reporting Measure and we proposed to reintroduce the NHSN Dialysis Event Reporting Measure into the ESRD QIP measure set beginning with PY 2019.
We received general comments on the PY 2020 measure set. The comments and our responses for these proposals are set forth below.
For Hypercalcemia and Phosphorus, commenter recommended that CMS modify the exclusion criteria to state: “home dialysis patients for whom a facility does not submit a claim during the claim month or PD patients with fewer than 15 billable days or home HD patients with fewer than seven treatments during claim month.” Commenter argued that the way the specifications are currently written, home patients are required to receive a lab result while in-center patients have a six-treatment grace period. Additionally, if a home patient receives a treatment on the first of the month and then goes to the hospital for the remainder of the month, the patient-month will be counted as not meeting the standard. Patients are therefore being treated to medically unnecessary tests, and the commenter argued that this modification to the specifications for these measures will address this problem for patients who sift from in-center HD to home PD in relation to the hypercalcemia and phosphorus measures.
With regard to hypercalcemia and phosphorus, the commenter describes a claims-based exclusion paradigm that is not used for the hypercalcemia or phosphorus measures, nor is it consistent with the DFC specification of Kt/V. Irrespective of modality, patients are included in the measures' denominator based primarily on CROWNWeb admission and discharge data and not primarily on the number of Medicare Claims treatment events. In addition, assessment of calcium and phosphorus concentrations and avoidance of hypercalcemia apply equally to both In-center HD and home dialysis patients.
The concerns expressed by commenters include: (1) Patients need to be involved with the survey in a meaningful way; (2) The ESRD National Coordinating Center (NCC) LAN Affinity Group is in the process of trying to address #1; (3) Patients remain concerned with inconsistencies in the administration and understanding of the survey; (4) Patients remain concerned that while a minority of patients may see benefits from the results of the survey, it will not improve the patient experience of care or have a meaningful impact on process change at the facility level as it currently exists; (5) In light of these concerns, the current weight being assigned to this metric appears to be excessive. They recommended reconsideration for the weighting assigned to the CAHPS measure until these concerns are addressed.
The changes commenters recommended include: (1) Provide a specific list of the exclusions that would exclude homeless patients as well; (2) Expand the ICH CAHPS survey to include peritoneal dialysis and home hemodialysis patients in future rulemaking; (3) Administer the survey consistent with the AHRQ specifications, including by dividing it into three sections that were independently tested; (4) Require that the survey be administered only once each year, consistent with the findings of the American Institutes for Research/RAND et al.; (5) Coordinate with the ESRD Networks to reduce duplication in its administration; (6) Implement a mechanism for facilities to ensure that patients' contact information is as accurate and up-to-date as possible; (7) Review the lingual translations of the surveys to ensure that they are accurate.
Another commenter supported CMS's willingness to consider expanding the ICH CAHPS survey in future years to include peritoneal dialysis, home hemodialysis patients, and homeless patients. In the interim, they recommended that CMS consider certain modifications to the measure to make it less burdensome to facilities and patients. First, they recommended addressing concerns about the burden on patients by aligning the ICH CAHPS measure specifications with those AHRQ relied upon when testing the measure. Specifically, they recommended that CMS divide the survey into three sections, which were each independently tested, and they suggested reducing the requirement to a single administration of the survey each year. They also urged CMS to work with facilities to develop a mechanism to ensure that patients' contact information is accurate and up-to-date so that facilities are not penalized for non-response when the patient's address was incorrect and encouraged CMS to ensure that the ICH CAHPS survey is correctly translated for all foreign-language speakers, and that the translation is meaningful and accurate.
The AHRQ guidelines were not designed to support public reporting. They are, therefore, less detailed than the CMS guidelines, which are designed to improve data quality for public reporting. We conduct the survey twice a year in order to provide patients with multiple opportunities to report their experiences. We also report the data from two survey administrations to improve the possibility that the sample
Since short-term visitors can transmit or acquire influenza even when in a healthcare facility for a limited amount of time, all healthcare personnel working one day or more during the reporting period are included in the NHSN measure. Facilities are encouraged to develop tracking systems that will capture these data from short-term HCP when they come into the facility during the reporting period. Among short-term healthcare personnel, adult students/trainees and volunteers may be reasonably anticipated to have substantial contact with patients and/or other healthcare personnel in a healthcare facility, increasing the risk of acquiring or transmitting influenza infection during the influenza season. To alleviate the challenges associated with collecting data on groups that do not regularly work in a facility, CDC encourages facilities to devise tracking systems to reach these individuals. CDC developed an information sheet that lists methods and strategies on how this can be accomplished, based on interviews conducted with a sample of acute care facilities that collected these data during the 2012-2013 influenza season:
Commenter explained that one of the most problematic aspects of the STrR measure is that dialysis facilities are not always able to obtain information from other providers about patient transfusions that they need to understand the metric and act upon it. If this measure is going to be of value, dialysis facilities need to obtain quarterly data bout the raw transfusion, hospitalization, readmissions, and mortality data using DFR calculations, and the six-month lagged data file. Without this important information, facilities have no insight on patients who may or may not be receiving transfusions.
Dialysis providers are responsible for anemia management as part of the ESRD Conditions for Coverage. Best dialysis provider practice should include effective anemia management algorithms that focus on (1) prevention and treatment of iron deficiency, inflammation and other causes of ESA resistance, (2) use of the lowest dose of ESAs that achieves an appropriate target hemoglobin that is consistent with FDA guidelines and current best practices including transfusion avoidance, and (3) education of patients, their families and medical providers to avoid unnecessary blood transfusion so that risk of allosensitization is minimized, eliminating or reducing one preventable barrier to successful kidney transplantation.
The STrR measures dialysis facility performance in avoidance of transfusions for their patients. We agree that the majority of blood transfusions occur during hospitalization. However, the results of pre-hospitalization anemia management, reflected in achieved hemoglobin concentration prior to hospitalization, are a significant contributor to transfusion risk. The decision to transfuse blood is intended to improve or correct the pathophysiologic consequences of severe anemia, defined by achieved hemoglobin or hematocrit, in a specific clinical context for each patient situation (8). Consensus guidelines in the U.S. and other consensus guidelines defining appropriate use of blood transfusions are based, in large part, on the severity of anemia (9-11). Given the role of hemoglobin as a clinical outcome that defines anemia as well as forms a basis for consensus recommendations regarding use of blood transfusion, it is not surprising that the presence of decreased hemoglobin concentration is a strong predictor of subsequent risk for blood transfusion in multiple settings, including chronic dialysis (12-21). For example, Gilbertson, et al. found a nearly four-fold higher risk-adjusted transfusion rate in dialysis patients with achieved hemoglobin <10 gm/dl compared to those with >10 gm/dl hemoglobin. (19) In addition to achieved hemoglobin, other factors related to dialysis facility practices, including the facility's response to their patients achieved hemoglobin, may influence blood transfusion risk in the chronic dialysis population (22, 25). In an observational study recently published by Molony, et al. (2016) comparing different facility level titration practices, among patients with hemoglobin <10 and those with hemoglobin >11, they found increased transfusion risk in patients with larger ESA dose reductions and smaller dose escalations, and reduced transfusion risk in patients with larger ESA dose increases and smaller dose reductions (25). The authors reported no clinically meaningful differences in all-cause or cause-specific hospitalization events across groups.
We appreciate the offer to consider additional measures that might more comprehensively assess anemia management care provided by dialysis facilities and are willing to discuss this issue with stakeholders in the future. We are also aware of the desire within the community for more granular detail with regard to quality of care and we will look into ways to provide this level of detail. The recently released ESRD Measures Manual does provide a great amount of detail on technical microspecifications related to the ways in which measures are calculated and we are continuing to find ways to make the process more transparent for the community. The commenter mentioned the DFRs, and it may be that other quality programs, such as Dialysis Facility Compare and the DFR offer more opportunity for this type of quality improvement data.
The Comprehensive Dialysis Adequacy Clinical Measure does not clinically co-mingle different groups of patients. Rather, peritoneal dialysis patients are assessed based on clinical standards appropriate for these patients, while hemodialysis patients are assessed based on clinical standards appropriate for them. Similarly, adult and pediatric patients are assessed based on clinical standards that are appropriate for each of those groups. We understand that patient groups that comprise a smaller percentage of a facility's total population will have less impact on the facility's performance score for the Comprehensive Dialysis Adequacy clinical measure. The alternative, however, is to implement individual measures for each subpopulation in the Comprehensive Dialysis Adequacy clinical measure, as we had done previously. This would reintroduce the problem of limiting our ability to assess dialysis adequacy for patients in facilities large enough to provide reliable assessments using the Comprehensive Dialysis Adequacy clinical measure, but also lacking enough patients within the individual subpopulations to provide reliable assessments using the more granular measures of dialysis adequacy previously implemented in the ESRD QIP.
With regard to the question of whether the measure was described as “pooled” or “composite” at the Measures Application Partnership, we don't believe characterizing it as a composite measure at the time of MAP review changes the substance of what the MAP discussed; “pooled” was always part of the measure concept. The measure design and specifications are not substantively changed from those reviewed by the MAP.
Finally, this measure was not endorsed due to a limited performance gap criterion. This was also identified for some the previously implemented Kt/V dialysis adequacy measures that had been previously endorsed and implemented on ESRD QIP, but exhibited limited variation in performance. These measures retained a “reserve” endorsed status, which reflects that while other NQF criteria are met, performance on the measure is extremely high. The Comprehensive Dialysis Adequacy measure is not eligible for this designation by NQF because it had not been previously endorsed. However, it is methodologically aligned with these “reserve” measures, leading us to conclude that it is methodologically sound. Returning to the use of the more granular measures of dialysis adequacy would not address the underlying concern reflected in this comment, which is that the performance gap is limited, as this is reflected by these measures current “reserve” status. Under MIPPA, we are required to assess dialysis adequacy as part of the QIP. Because the Comprehensive Dialysis Adequacy clinical measure allows us to assess dialysis adequacy among the greater number of dialysis patients, we believe its continued implementation is appropriate.
We thank commenters for their suggestions on improving the measures included in the program and we will consider the feasibility of making some of their recommended changes in future years of the program.
Hospitalization rates are an important indicator of patient morbidity and quality of life. On average, dialysis patients are admitted to the hospital nearly twice a year and spend an average of 11.2 days in the hospital per year.
At the end of 2013 there were 661,648 patients being dialyzed, of which 117,162 were new (incident) ESRD patients.
Hospitalization measures have been in use in the Dialysis Facility Reports (formerly Unit-Specific Reports) since 1995. The Dialysis Facility Reports are used by the dialysis facilities and ESRD Networks for quality improvement, and by ESRD state surveyors for monitoring and surveillance. In particular, the Standardized Hospitalization Ratio (SHR) for Admissions is used in the CMS ESRD Core Survey Process, in conjunction with other standard criteria for prioritizing and selecting facilities to survey. In addition, the SHR has been found to be predictive of dialysis facility deficiency citations in the past (ESRD State Outcomes List). The SHR is also a measure that has been publicly reported since January 2013 on the Centers for Medicare and Medicaid Services (CMS) Dialysis Facility Compare Web site.
The SHR measure is an NQF-endorsed all-cause, risk-standardized rate of hospitalizations during a 1-year observation window. The Measures Application Partnership supports the direction of this measure for inclusion in the ESRD QIP.
We proposed to adopt a modified version of the SHR currently endorsed by NQF (NQF #1463). We have submitted this modified measure to NQF for endorsement consideration as part of the standard maintenance process for NQF #1463. When we previously proposed the SHR for implementation in the QIP, we received public comments urging us to not rely solely on CMS Medical Evidence Form 2728 as the only source of patient comorbidity data in the risk-adjustment calculations for the SHR measure. These comments correctly stated that incident comorbidity data are collected for all ESRD patients on CMS Form 2728 when patients first become eligible to receive Medicare ESRD benefits, regardless of payer. Although CMS Form 2728 is intended to inform both facilities and us whether one or more comorbid conditions are present at the start of ESRD, “there is currently no mechanism for either correcting or updating patient comorbidity data on CMS' Medical Evidence Reporting Form 2728” (76 FR 70267). Commenters were concerned that risk-adjusting the SHR solely on the basis of comorbidity data from CMS Form 2728 would create access to care problems for patients, because patients typically develop additional comorbidities after they begin chronic dialysis, and facilities would have a disincentive to treat these patients if recent comorbidities were not included in the risk-adjustment calculations (77 FR 67495 through 67496).
In the CY 2013 ESRD PPS proposed rule, we noted that updated comorbidity data could be captured on the ESRD 72x claims form. Some public comments stated that, “reporting comorbidities on the 72x claim could be a huge administrative burden for facilities, including time associated with validating that the data they submit on these claims is valid” (77 FR 67496). In response to these comments, we stated that we would “continue to assess the best means available for risk-adjustment for both the SHR and Standardized Mortality Ratio (SMR) measures, taking both the benefits of the information and the burden to facilities into account, should we propose to adopt these measures in future rulemaking” (77 FR 67496). We proposed to adopt a Comorbidity Reporting Measure for the PY 2016 ESRD QIP. This measure would have allowed us to collect and analyze the updated comorbidity data “to develop risk adjustment methodologies for possible use in calculating the SHR and SMR measures” (78 FR 72208). We chose not to finalize the comorbidity measure “as a result of the significant concerns expressed by commenters (78 FR 72209).
In response to the comments on the SHR when originally proposed, and subsequently the proposed comorbidity reporting measure, we have made revisions to the SHR specifications. The modified SHR that we have proposed to adopt beginning with the PY 2020 ESRD QIP includes a risk adjustment for 210 prevalent comorbidities in addition to the incident comorbidities from the CMS Medical Evidence Form 2728. The 210 prevalent comorbidities were identified through review by a Technical Expert Panel (TEP) first convened in late 2015. The details of how the 210 comorbidities were identified are described below. We proposed to identify these prevalent comorbidities for purposes of risk adjusting the measure using available Medicare claims data. We believe this approach allows us to address commenters' concerns about increased reporting burden, while also resulting in
Our understanding is that the NQF evaluates measures on the basis of four criteria: Importance, scientific acceptability, feasibility, and usability. The validity and reliability of a measure's risk-adjustment calculations fall under the “scientific acceptability” criterion, and Measure Evaluation Criterion 2b4 specifies NQF's preferred approach for risk-adjusting outcome measures (
Reflecting these criteria, the TEP evaluated a list of prevalent comorbidities derived through the following process. First, the ESRD Hierarchical Comorbidity Conditions (ESRD-HCCs) were used as a starting point to identify ICD-9 diagnosis codes that could be used for risk adjustment. Those individual ICD-9 conditions that comprised the respective ESRD HCCs, with a prevalence of at least 0.1 percent in the patient population, were then selected for analysis to determine their statistical relationship to mortality or hospitalization. This step resulted in 555 diagnoses for comorbidities (out of over 3000 ICD-9 diagnosis codes in the ESRD-HCCs). Next, an adaptive lasso variable selection method was applied to these 555 diagnoses to identify those with a statistically significant relationship to mortality and/or hospitalization (p < 0.05). This process identified 242 diagnoses. The TEP members then scored each of these diagnoses as follows:
1. Very likely the result of dialysis facility care.
2. Likely the result of dialysis facility care.
3. May or may not be the result of dialysis facility care.
4. Unlikely to be the result of dialysis facility care.
5. Very likely not the result of dialysis facility care.
This scoring exercise aimed at identifying a set of prevalent comorbidities are not likely the result of facility care and therefore potentially are risk adjusters for SHR and SMR. The TEP concluded that comorbidities scored as “unlikely” or “very unlikely the result of facility care” by at least half of TEP members (simple majority) were appropriate for inclusion as risk-adjusters. This process resulted in 210 conditions as risk adjustors. The TEP recommended incorporation of these adjustors in the risk model for the SHR, and CMS concurred.
Section 1881(h)(2)(B)(i) of the Act requires that, unless the exception set forth in section 1881(h)(2)(B)(ii) of the Act applies, the measures specified for the ESRD QIP under section 1881(h)(2)(A)(iv) of the Act must have been endorsed by the entity with a contract under section 1890(a) of the Act (that entity currently is NQF). Under the exception set forth in section 1881(h)(2)(B)(ii) of the Act, in the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the entity with a contract under section 1890(a) of the Act, the Secretary may specify a measure that is not so endorsed, so long as due consideration is given to measures that have been endorsed or adopted by a consensus organization identified by the Secretary. We have given due consideration to endorsed measures, including the endorsed SHR (NQF #1463), as well as those adopted by a consensus organization, and we proposed this measure under the authority of 1881(h)(2)(B)(ii) of the Act. Although the NQF has endorsed a hospitalization measure (NQF #1463), our analyses suggest that incorporating prevalent comorbidities results in a more robust and reliable measure of hospitalization.
We have analyzed the measure's reliability, the results of which are provided below and in greater detail in the SHR Measure Methodology report, available at:
Overall, we found that IURs for the 1-year SHRs have a range of 0.70 through 0.72 across the years 2010, 2011, 2012 and 2013, which indicates that two-thirds of the variation in the 1-year SHR can be attributed to the between-facility differences and one-third to within-facility variation. Table 14 below shows the IURs for the 1-year SHR.
In addition, SHR is negatively correlated in each of the 4-years with the measure assessing percentage of patients in the facility with an AV Fistula (Spearman's rho = −0.12, −0.15, −0.12, −0.13). Thus higher values of SHR are associated with lower usage of AV Fistulas. Further, SHR is positively correlated with catheter use >=90 days (Spearman's rho = 0.21, 0.21, 0.18, 0.16), indicating that higher values of SHR are associated with increased use of catheters. These correlations are all highly significant (p < 0.001). For each year of 2010 through 2013, the SHR is also found to be negatively correlated with the percent of hemodialysis patients with Kt/V >= 1.2, again in the direction expected (Spearman's rho = −0.11, −0.13, −0.10, −0.11; p < 0.0001). Lower SHRs are associated with a higher percentage of patients receiving adequate dialysis dose.
Data are derived from an extensive national ESRD patient database, which is largely derived from the CMS Consolidated Renal Operations in a Web-enabled Network (CROWN), which includes Renal Management Information System (REMIS), and the Standard Information Management System database, the Enrollment Database, Medicare dialysis and hospital payment records, the CMS Medical Evidence Form (Form CMS-2728), transplant data from the Organ Procurement and Transplant Network, the Death Notification Form (Form CMS-2746), the Nursing Home Minimum Dataset, the Dialysis Facility Compare and the Social Security Death Master File. The database is comprehensive for Medicare Parts A and B patients. Non-Medicare patients are included in all sources except for the Medicare payment records. Standard Information Management System/CROWNWeb provides tracking by dialysis provider and treatment modality for non-Medicare patients. Information on hospitalizations and patient comorbidities are obtained from Medicare Inpatient Claims Standard Analysis Files.
The outcome for this measure is the number of inpatient hospital admissions among eligible chronic dialysis patients under the care of the dialysis facility during the 1-year reporting period.
The measure eligible population includes adult and pediatric Medicare ESRD patients who have reached day 91 of ESRD treatment and who received dialysis within the 1-year period.
Patients are included in the measure after the first 90 days of treatment. For each patient, we identify the dialysis provider at each point in time. Starting with day 91 of ESRD treatment, we attribute patients to facilities according to the following rules. A patient is attributed to a facility once the patient has been treated there for 60 days. When a patient transfers from one facility to another, the patient continues to be attributed to the original facility for 60 days and then is attributed to the destination facility. In particular, a patient is attributed to his or her current facility on day 91 of ESRD treatment if that facility had treated him or her for at least 60 days. If on day 91, the facility had treated a patient for fewer than 60 days, we wait until the patient reaches day 60 of treatment at that facility before attributing the patient to the facility. When a patient is not treated in a single facility for a span of 60 days (for instance, if there were two switches within 60 days of each other), we do not attribute that patient to any facility. Patients are removed from facilities 3 days prior to transplant in order to exclude the transplant hospitalization. Patients who withdrew from dialysis or recovered renal function remain assigned to their treatment facility for 60 days after withdrawal or recovery.
The SHR measure estimates expected hospitalizations calculated from a Cox model that adjusts for patient risk factors and demographic characteristics. This model accounts for clustering of patients in particular facilities and allows for an estimate of the performance of each individual facility, while applying the risk adjustment model to obtain the expected number of hospitalizations for each facility. The model does not adjust for sociodemographic status. We understand the important role that sociodemographic status plays in the care of patients. However, we continue to have concerns about holding dialysis facilities to different standards for the outcomes of their patients of diverse sociodemographic status because we do not want to mask potential disparities or minimize incentives to improve the outcomes of disadvantaged populations. We routinely monitor the impact of sociodemographic status on facilities' results on our measures.
NQF is currently undertaking a 2-year trial period in which new measures and measures undergoing maintenance review will be assessed to determine if risk-adjusting for sociodemographic factors is appropriate. For 2-years, NQF will conduct a trial of a temporary policy change that will allow inclusion of sociodemographic factors in the risk-adjustment approach for some performance measures. At the conclusion of the trial, NQF will determine whether to make this policy change permanent. Measure developers must submit information such as analyses and interpretations as well as performance scores with and without sociodemographic factors in the risk adjustment model.
Furthermore, the Office of the Assistant Secretary for Planning and Evaluation is conducting research to examine the impact of sociodemographic status on quality measures, resource use, and other measures under the Medicare program as directed by the Improving Medicare Post-Acute Care Transformation Act. We will closely examine the findings of the Assistant Secretary for Planning and Evaluation studies and consider how they apply to our quality programs at such time as they are available.
The SHR measure is calculated as the ratio of the number of observed hospitalizations to the number of expected hospitalizations. A ratio greater than one means that facilities have more hospitalizations than would be expected for an average facility with a similar patient-mix; a ratio less than one means the facility has fewer hospitalizations than would be expected for an average facility with a similar patient-mix.
The SHR uses expected hospital admissions calculated from a Cox model as extended to handle repeated events, with piecewise constant baseline rates. The model is fit in two stages. The stage 1 model is first fitted to the national data with piecewise constant baseline rates applied to each facility. Hospitalization rates are adjusted for patient age, sex, diabetes, duration of ESRD, nursing home status, BMI at
The SHR is a point estimate—the best estimate of a facility's hospitalization rate based on the facility's patient-mix. For more detailed information on the calculation methodology please refer to our Web site at:
We sought comments on our proposal to adopt the SHR measure for the ESRD QIP beginning with PY 2020. The comments and our responses for these proposals are set forth below.
Several commenters appreciated CMS's proposal to cast the SHR measure in terms of patient-years rather than patient numbers but noted that even under a scenario of a small facility with 50 patients, for example, where all 50 contribute 12 months of data to the denominator, the data indicate that the facility's performance score would still be more due to random chance than actual performance. These commenters stated that smaller facilities will have even lower reliability, possibly low enough to make the measure completely unreliable. One commenter added that even for medium sized facilities, the IUR is below the 0.7 threshold and argued that it is therefore inappropriate to penalize facilities when so much of their performance on the measure is due to random chance.
Given the established effect of sample size on IUR calculations, it is expected that large facilities will have higher IUR values and small facilities will have lower IUR values for any given measure. CMS and consensus-endorsement bodies consider the overall reliability in determining the acceptability of the measure. We are aware of no published literature standard requiring an IUR of 0.7 for quality measure implementation, and are aware of no standard by NQF requiring this threshold as the minimum for endorsement or implementation. Nonetheless, the SHR does achieve an overall IUR of >.7.
Table 15 below stratifies facilities into three strata based on patient years at risk for each facility.
Table 16 below stratifies into three strata based on the number of patients for each facility.
Additionally, commenters are concerned that the proposed SHR measure inappropriately penalizes facilities for hospitalizations over which they have little to no control, such as from foot ulcers, lupus flare-ups, myocardial infarction, congestive heart failure, etc. They pointed out that many providers are involved in the care of ESRD patients and that while there is a need to coordinate with other providers, it is not always feasible. Providers struggle with different EMR systems which often do not communicate with one another and there is often a lack of resources on either side which prevents effective communication efforts. Commenters recommended that rather than implementing an all-cause hospitalization measure, CMS should consider specific measures such as hospitalization for catheter infection, hospitalization for volume overload, hospitalization for anemia/blood transfusions, etc. so that facilities are only being held accountable for hospitalizations related to conditions directly related to the patient's dialysis treatment.
The 2007 TEP that participated in developing the SHR considered the possibility of developing cause specific SHRs, but recommended the use of all-cause SHR measures due to various reasons including the lack of clear research to indicate what causes (that is, reason for admission) should be selected as valid indicators of poor ESRD care, and issues associated with inter-rater reliability in assessing cause of hospitalization. The TEP reached a strong consensus that the all-cause measure would be reliable and valid and the measure would typically be related to quality of care. We have some crude measures of cause of hospitalization which we have used to assess the relationship between the all-cause measure and cause specific components. These measures are useful in assessing the overall SHR measures, but we caution that the cause specific hospitalizations have not been tested or validated at this time. All correlations are in the expected direction and highly significant, (p<0.0001). Thus these preliminary analyses show that the overall hospitalization rate also correlates with specific causes that are commonly thought to be potentially related to poor quality of care.
As mentioned above, for PY 2020 we proposed to adopt a new Proposed Serum Phosphorus Reporting Measure. Section 1881(h)(2)(A)(iii) of the Act states that the measures specified for the ESRD QIP shall include other measures as the Secretary specifies, including, to the extent feasible, measures of bone mineral metabolism. Abnormalities of bone mineral metabolism are exceedingly common and contribute significantly to morbidity and mortality in patients with advanced Chronic Kidney Disease (CKD). Numerous studies have associated disorders of mineral metabolism with morbidity, including fractures, cardiovascular disease, and mortality. Overt symptoms of these abnormalities often manifest in only the most extreme states of calcium-phosphorus dysregulation, which is why we believe that routine blood testing of calcium and phosphorus is necessary to detect abnormalities.
The proposed Serum Phosphorus Reporting Measure is based on a serum phosphorus measure that is endorsed by the NQF (NQF #0255), which evaluates the extent to which facilities monitor and report patient phosphorus levels. In addition, and as explained above, the proposed Serum Phosphorus Reporting Measure is collected using CROWNWeb data and excludes patients using criteria consistent with other ESRD QIP measures. The Measure Applications Partnership expressed full support for this measure.
For PY 2020 and future payment years, we proposed that facilities must report serum or plasma phosphorus data to CROWNWeb at least once per month for each qualifying patient. Qualifying patients for this proposed measure are defined as patients 18 years of age or older, who have a completed CMS Medical Evidence Form 2728, who have not received a transplant with a functioning graft, and who are assigned to the same facility for at least the full calendar month (for example, if a patient is admitted to a facility during the middle of the month, the facility will not be required to report for that patient for that month). We further propose that facilities will be granted a one-month period following the calendar month to enter this data. For example, we would require a facility to report Serum Phosphorus rates for January 2018 on or before February 28, 2018. Facilities would be scored on whether they successfully report the required data within the timeframe provided, not on the values reported. Technical specifications for the Serum Phosphorus reporting measure can be found at:
We sought comments on this proposal. The comments and our responses are set forth below.
The ultrafiltration rate measures the rapidity with which fluid (ml) is removed during dialysis per unit (kg) of body weight in unit (hour) time. A patient's ultrafiltration rate is under the control of the dialysis facility and is monitored throughout a patient's hemodialysis session. Studies suggest that higher ultrafiltration rates are associated with higher mortality and higher odds of an “unstable” dialysis session,
We have given due consideration to endorsed measures, as well as those adopted by a consensus organization. Because no NQF-endorsed measures or measures adopted by a consensus organization that require reporting of relevant ultrafiltration data currently
The proposed Ultrafiltration Rate reporting measure is based upon the NQF-endorsed Avoidance of Utilization of High Ultrafiltration Rate (>/= 13 ml/kg/hr) (NQF #2701). This measure assesses the percentage of patient-months for patients with an ultrafiltration rate greater than or equal to 13 ml/kg/hr. The Measure Applications Partnership expressed full support for this measure.
For PY 2020 and future payment years, we proposed that facilities must report the following data to CROWNWeb for all hemodialysis sessions during the week of the monthly Kt/V draw submitted to CROWNWeb for that clinical month, for each qualifying patient (defined below):
We sought comments on this proposal. The comments and our responses for these proposals are set forth below.
Several commenters expressed concern about the clinical rationale behind the UFR measure's technical specifications. Specifically, one commenter noted that the KDOQI hemodialysis adequacy clinical practice guidelines do not include a target for UFR and instead recommend minimizing UFR as much as possible to maximize hemodynamic stability and tolerability of the hemodialysis procedure. The commenter stated that the reason for this is that there is limited evidence for setting a specific target, and that one study suggested an increased risk for individuals with heart failure with a UFR between 10-14 ml/h/kg but improvements for those without heart failure with a UFR in that range. The commenter therefore stated that they would support the implementation of NQF #2701 in the QIP with the knowledge that there will be challenges in the implementation process that will require efforts from facilities, staff, physicians and patients to ensure patient participation and adherence to their dialysis prescription and fluid restrictions. The commenter stated that the KCQA measure excludes patients who dialyze for less time than the average patient, and commenter urged CMS to include this exclusion. Commenters added that due to individualized patient responses to fluid removal, it is difficult to arrive at a single rate for UFR that is “too high” for patients. Rather than the UFR >/= 13 ml/kg/hr that CMS has proposed, commenters urged CMS to consider a measure of UFR >/= 10 ml/kg/hr. One commenter suggested that they would not recommend excluding patients who dialyze more than 3 times per week, transient patients or patients who are new to ESRD because these patients would not be expected to be at risk of developing intradialytic hypotension when compared to the general ESRD population. Another commenter specifically recommended that CMS exclude patients with <3 hemodialysis treatments in the facility during the reporting month. One commenter also suggested that patients who are new to ESRD and in their first 90 days of treatment should not be excluded from any UFR reporting requirements because of their particularly high mortality risk. Finally, one commenter stated that they would support efforts by CMS to ensure that time on dialysis is adjusted in such a way that patients would not suffer from symptoms related to rapid ultrafiltration. The commenter stated that monitoring Kt/V solely instead of taking into consideration the greater role of fluid management and removal is likely to result in more problems with sickness for patients, potentially impacting quality of life, and that while correction of uremia remains important, limiting our focus on the rate of fluid removal is to the detriment of patients, leading to an increase in the risk of cardiovascular disease.
The rate threshold of >13 ml/kg/hr was chosen to be consistent with the NQF endorsed threshold, and is also consistent with most of the published evidence demonstrating associations of poorer outcomes with UFR between 10-15 ml/kg/hr.
We thank the commenter for generally supporting the importance of the UFR
Specifically, commenters requested that CMS retain the exclusion of facilities with 25 or fewer patients, rather than the modified “fewer than 11 patients” that CMS proposed, because commenters believe this modification would hurt small facilities. Additionally, commenters requested that CMS expressly state that reporting the number of hemodialysis sessions delivered during the Kt/V week will be required for the reporting measure because the NQF-endorsed measure excludes patients regularly prescribed >3 sessions/week. They noted that CMS has not indicated this requirement and that NQF 2701 excludes patients regularly prescribed >3 sessions/week. Commenters asked for confirmation that the intent is to implement this measure as specified for those patients receiving thrice weekly HD. Commenters requested clarification as to whether excluding patients on dialysis <90 days at the beginning of the reporting month, an exclusion not present in the KCQA measure, was a data collection issue, or whether CMS has any additional justification for this approach.
We proposed to establish CY 2018 as the performance period for the PY 2020 ESRD QIP for all but the NHSN Healthcare Personnel Influenza Vaccination reporting measure because it is consistent with the performance periods we have historically used for these measures and accounts for seasonal variations that might affect a facility's measure score.
We proposed that the performance period for the NHSN Healthcare Personnel Influenza Vaccination reporting measure will be from October 1, 2016 through March 31, 2017, because this period spans the length of the 2016-2017 influenza season.
We sought comments on these proposals. The comments and our responses for these proposals are set forth below.
One commenter also expressed concerns with the CCN Open Date criteria for the NHSN HCP Influenza Vaccination Reporting Measure. They suggested that if the flu season spans from October 1, 2016 through March 31, 2017, then the CCN open date should be January 1, 2016 rather than January 1, 2017. Similarly, for the flu season that spans from October 1, 2017 through March 31, 2018, facilities should be required to have a CCN open date of January 1, 2017. The reason for this is that if a facility is certified on December 31, 2016, they are still required to report this data for the full 2016/2017 flu season even though they were not certified for the full flu season and they should not be required to create a detailed employee log to track the vaccination status of each employee while also having to focus on opening a new facility, keeping track of new admits, and registering for CROWNWeb and NHSN access.
With regards to commenter's suggestion about our CCN Open Date policy, we accounted for this concern in the CY 2015 ESRD PPS Final Rule (79 FR 66212). We stated that facilities with a CCN open date
Section 1881(h)(4)(A) of the Act provides that “the Secretary shall establish performance standards with respect to measures selected . . . for a performance period with respect to a year.” Section 1881(h)(4)(B) of the Act further provides that the “performance standards . . . shall include levels of achievement and improvement, as determined appropriate by the Secretary.” We use the performance standards to establish the minimum score a facility must achieve to avoid a Medicare payment reduction. We use achievement thresholds and benchmarks to calculate scores on the clinical measures.
For the same reasons stated in the CY 2013 ESRD PPS final rule (77 FR 67500 through 76502), we proposed for PY 2020 to set the performance standards, achievement thresholds, and benchmarks for the clinical measures at the 50th, 15th, and 90th percentile, respectively, of national performance in CY 2016, because this will give us enough time to calculate and assign numerical values to the proposed performance standards for the PY 2020 program prior to the beginning of the performance period. We continue to believe these standards will provide an incentive for facilities to continuously improve their performance, while not
We sought comments on these proposals. The comments and our responses for these proposals are set forth below.
At this time, we do not have the necessary data to assign numerical values to the proposed performance standards for the clinical measures, because we do not yet have data from CY 2016 or the first portion of CY 2017. We will publish values for the clinical measures, using data from CY 2016 and the first portion of CY 2017, in the CY 2018 ESRD PPS final rule.
In the CY 2014 ESRD PPS final rule, we finalized performance standards for the Anemia Management and Mineral Metabolism reporting measures (78 FR 72213). We did not propose any changes to these policies for the PY 2020 ESRD QIP.
In the CY 2016 ESRD PPS final rule, we finalized performance standards for the Screening for Clinical Depression and Follow-Up, Pain Assessment and Follow-Up, and NHSN Healthcare Provider Influenza Vaccination reporting measures (79 FR 66209). We did not propose any changes to these policies.
For the proposed Ultrafiltration Rate Reporting Measure, we proposed to set the performance standard as successfully reporting the following data to CROWNWeb for all hemodialysis sessions during the week of the monthly Kt/V draw for that clinical month, for each qualifying patient (1) HD Kt/V Date; (2) Post-Dialysis Weight; (3) Pre-Dialysis Weight; (4) Delivered Minutes of BUN Hemodialysis; and (5) Number of sessions of dialysis delivered by the dialysis unit to the patient in the reporting month. This information must be submitted for each qualifying patient in CROWNWeb on a monthly basis, for each month of the reporting period. For the proposed Serum Phosphorus Reporting measure, we proposed to set the performance standard as successfully reporting a serum phosphorus value for each qualifying patient in CROWNWeb on a monthly basis, for each month of the reporting period. For the proposed NHSN Dialysis Event Reporting measure, we proposed to set the performance standard as successfully reporting 12 months of data from CY 2018.
We sought comments on these proposals. We did not receive any comments on these proposed policies for setting Performance Standards for the PY 2020 Reporting Measures.
In the CY 2014 ESRD PPS Final Rule, we finalized a policy for scoring performance on clinical measures based on achievement (78 FR 72215). Under this methodology, facilities receive points along an achievement range based on their performance during the performance period for each measure, which we define as a scale between the achievement threshold and the benchmark. In determining a facility's achievement score for each clinical measure under the PY 2020 ESRD QIP, we proposed to continue using this methodology for all clinical measures except the ICH CAHPS clinical measure. The facility's achievement score would be calculated by comparing its performance on the measure during CY 2018 (the proposed performance period) to the achievement threshold and benchmark (the 15th and 90th percentiles of national performance on the measure in CY 2016).
We sought comment on this proposal. We did not receive any comments on this proposal.
In the CY 2014 ESRD PPS Final Rule, we finalized a policy for scoring performance on clinical measures based on improvement (78 FR 72215 through 72216). In determining a facility's improvement score for each measure under the PY 2020 ESRD QIP, we proposed to continue using this methodology for all clinical measures except the ICH CAHPS clinical measure. Under this methodology, facilities receive points along an improvement range, defined as a scale running between the improvement threshold and the benchmark. We proposed to define the improvement threshold as the facility's performance on the measure during CY 2017. The facility's improvement score would be calculated by comparing its performance on the measure during CY 2018 (the proposed performance period) to the improvement threshold and benchmark.
We sought comment on this proposal. The comments and our responses are set forth below.
In the CY 2015 ESRD PPS final rule, we finalized a policy for scoring performance on the ICH CAHPS clinical measure based on both achievement and improvement (79 FR 66209 through
We sought comments on this proposal.
In the CY 2013 ESRD PPS final rule, we finalized policies for scoring performance on the Anemia Management and Mineral Metabolism reporting measures in the ESRD QIP (77 FR 67506). We did not propose any changes to these policies for the PY 2020 ESRD QIP.
In the CY 2015 ESRD PPS final rule, we finalized policies for scoring performance on the Clinical Depression Screening and Follow-Up, Pain Assessment and Follow-Up, and NHSN Healthcare Provider Influenza Vaccination reporting measures (79 FR 66210 through 66211). We did not propose any changes to these policies.
With respect to the proposed Ultrafiltration Rate and Serum Phosphorus reporting measures, we proposed to score facilities with a CMS Certification Number (CCN) Open Date before July 1, 2018 using the same formula previously finalized for the Mineral Metabolism and Anemia Management reporting measures (77 FR 67506):
We sought comments on these proposals. We did not receive comments on these proposals.
In light of the proposed removal of the Safety Subdomain from the Clinical Measure Domain, our policy priorities for quality improvement for patients with ESRD discussed in section IV.C.6 of the proposed rule (81 FR 42826), and the criteria finalized in the CY 2015 ESRD PPS Final Rule used to assign weights to measures in a facility's Clinical Measure Domain score (79 FR 66214 through 66216), we proposed to weight the following measures in the following subdomains of the proposed clinical measure domain as follows (see Table 17):
Specifically, we proposed to reduce the weight of the Safety Measure Domain in light of validation concerns discussed above in the context of the proposal to reintroduce the NHSN Dialysis Event Reporting Measure (see Section (IV)(1)(a) above). For PY 2020 we proposed to reduce the weight of the Safety Measure Domain from 15 percent
We also proposed to weight the proposed SHR Clinical Measure at 11 percent of a facility's Clinical Measure Domain score. Facilities have had significant experience with SHR via public reporting on Dialysis Facility Compare, and reducing hospitalizations is a top policy goal for CMS. Further, increasing the emphasis on outcome measures is an additional policy goal of CMS, for reasons discussed above. For these reasons, we believe it is appropriate to weight the proposed SHR Clinical Measure at 11 percent of a facility's Clinical Measure Domain score.
Next, we proposed to decrease the weight of the Hypercalcemia clinical measure within the Clinical Care Subdomain to 2 percent of a facility's clinical domain score. We proposed to do so at this time to accommodate the weight assigned to the proposed SHR measure. The Hypercalcemia clinical measure was recently re-endorsed at NQF with a reserved status because there was very little room for improvement and facility scores on the measure are very high overall. Although this is true, the Hypercalcemia clinical measure does not meet the criterion for being topped out in the ESRD QIP (as described in section IV.D. of the proposed rule (81 FR 42833)). Therefore, despite its limited value for assessing facility performance, we decided not to propose to remove the Hypercalcemia clinical measure from the ESRD QIP measure set, but rather to significantly reduce its weight in the clinical subdomain because it provides some indication of the quality of care furnished to patients by facilities.
Finally, to accommodate the proposed addition of the SHR Clinical Measure beginning in PY 2020 and the proposed reduction in weight of the Hypercalcemia measure, we proposed to reduce the weights of the following measures by 1 percentage point each from what we proposed for PY 2019, within the Clinical Measure Domain: ICH CAHPS, SRR, STrR, Dialysis Adequacy, and Vascular Access Type. As illustrated in Table 10, these minor reductions in the weights of these measures in the Clinical Measure Domain would be counterbalanced by the increase in the overall percent of the TPS that we proposed to make to the Clinical Measure Domain, such that the proposed weights for these measures as a percentage of the TPS will remain as constant as possible from PY 2019 to PY 2020. Accordingly, this proposal would generally maintain the percentage of the TPS assigned to these measures.
We sought comments on these proposals. The comments and our responses to are set forth below.
We continue to believe that while the reporting measures are valuable, the clinical measures evaluate actual patient care and therefore justify a higher combined weight (78 FR 72217). We proposed to reduce the weight of the Safety Measure Domain from 15 percent of a facility's TPS for PY 2019 to 10 percent of a facility's TPS for PY 2020. We are gradually reducing the weight of this Safety Measure Domain over the course of 2 years because we believe it is important to reduce the weight of the Domain in light validation concerns, but it is important to maintain as much consistency as possible in the QIP Scoring Methodology from year to year.
We proposed that for PY 2020, to be eligible to receive a TPS, a facility must be eligible to be scored on at least one measure in the Clinical Measure Domain and at least one measure in the Reporting Measure Domain.
We sought comments on these proposals. The comments and our responses for these proposals are set forth below.
In this section, we provide an example to illustrate the scoring methodology for PY 2020. Figures 6-9 illustrate how to calculate the Clinical Measure Domain score, the Reporting Measure Domain score, the Safety Measure Domain score, and the TPS. Figure 10 illustrates the full scoring methodology for PY 2020. Note that for this example, Facility A, a hypothetical facility, has performed very well. Figure 6 illustrates the methodology used to calculate the Clinical Measure Domain score for Facility A.
Figure 7 illustrates the general methodology for calculating the Reporting Measure Domain score for Facility A.
Figure 8 illustrates the methodology used for calculating the Safety Measure Domain score for Facility A.
Figure 9 illustrates the methodology used to calculate the TPS for Facility A.
Figure 10 illustrates the full scoring methodology for PY 2020.
We received comments on the Figures provided in this example. The comments and our responses are set forth below.
Additionally, in light of the weighting structure we are finalizing for PY 2020, we have created an updated figure, Figure 12 below, showing the weights we are finalizing. For PY 2020, the Safety Measure Domain will comprise 15 percent of the TPS, the Clinical Measure Domain will make up 75 percent of the TPS and the Reporting Measure Domain will make up 10 percent of the TPS.
Our policy is to score facilities on clinical and reporting measures for which they have a minimum number of qualifying patients during the performance period. With the exception of the Standardized Readmission Ratio, Standardized Hospitalization Ratio, Standardized Transfusion Ratio, and ICH CAHPS clinical measures, a facility must treat at least 11 qualifying cases during the performance period in order to be scored on a clinical or reporting measure. A facility must have at least 11 index discharges to be eligible to receive a score on the SRR clinical measure, 10 patient-years at risk to be eligible to receive a score on the STrR clinical measure, and 5 patient-years at risk to be eligible to receive a score on the SHR clinical measure. In order to receive a score on the ICH CAHPS clinical measure, a facility must have treated at least 30 survey-eligible patients during the eligibility period and receive 30 completed surveys during the performance period. We did not propose to change these minimum data policies for the measures that we proposed to continue including in the PY 2019 ESRD QIP measure set. For the proposed Ultrafiltration Rate and Serum Phosphorus Reporting Measures, we also proposed that facilities with at least 11 qualifying patients will receive a score on the measure. We believe that setting the case minimum at 11 for these reporting measures strikes the appropriate balance between the need to maximize data collection and the need to not unduly burden or penalize small facilities. We further believe that setting the case minimum at 11 is appropriate because this aligns with case minimum policy for the vast majority of the reporting measures in the ESRD QIP.
Under our current policy, we begin counting the number of months for which a facility is open on the first day of the month after the facility's CMS Certification Number (CCN) Open Date. Only facilities with a CCN Open Date before July 1, 2018 would be eligible to be scored on the Anemia Management, Mineral Metabolism, Pain Assessment and Follow-Up, Clinical Depression Screening and Follow-Up reporting measures, and only facilities with a CCN Open Date before January 1, 2018 would be eligible to be scored on the NHSN Bloodstream Infection Clinical Measure, ICH CAHPS Clinical Measure, and NHSN Healthcare Personnel Influenza Vaccination reporting measure. We further proposed that, consistent with our CCN Open Date policy for other reporting measures, facilities with a CCN Open Date after July 1, 2018, would not be eligible to receive a score on the Ultrafiltration Rate Reporting Measure because of the difficulties these facilities may face in meeting the requirements of this measure due to the short period of time left in the performance period.
Table 19 displays the proposed patient minimum requirements for each of the measures, as well as the proposed CCN Open Dates after which a facility would not be eligible to receive a score on a reporting measure.
We sought comments on these proposals. The comments and our responses for these proposals are set forth below.
Commenters offered the STrR as an example of the problem with the small sample sizes used. This measure was found to have very low reliability, particularly for small facilities. The IUR for facilities with sample sizes below 46 patients was about 0.4, suggesting that 60 percent of inter-facility difference was due to random noise rather than underlying performance. The SFA in this case only raises the scores for very small facilities but does not offset the substantial effect of random variation for small sample sizes.
Given the established effect of sample size on IUR calculations, it is expected that large facilities will have a higher IUR and that smaller facilities will have lower IUR values for any given measure. Reliability results by facility size were not required by NQF. However, the decision to include reliability based on tertiles of facility size was intended to enhance interpretation of the detail provided in the measure submission.
Regarding the commenter's recommendation to use an IUR of 0.7, we are not aware of any formal or prescriptive NQF guideline or standard
Section 1881(h)(3)(A)(ii) of the Act requires the Secretary to ensure that the application of the scoring methodology results in an appropriate distribution of payment reductions across facilities, such that facilities achieving the lowest TPSs receive the largest payment reductions. We proposed that, for the PY 2020 ESRD QIP, a facility will not receive a payment reduction if it achieves a minimum TPS that is equal to or greater than the total of the points it would have received if:
• It performed at the performance standard for each clinical measure; and
• It received the number of points for each reporting measure that corresponds to the 50th percentile of facility performance on each of the PY 2018 reporting measures.
The PY 2018 program is the most recent year for which we will have calculated final measure scores before the beginning of the performance period for PY 2020 (that is, CY 2018). Because we have not yet calculated final measure scores, we are unable to determine the 50th percentile of facility performance on the PY 2018 reporting measures. We will publish that value in the CY 2018 ESRD PPS final rule once we have calculated final measure scores for the PY 2018 program.
Section 1881(h)(3)(A)(ii) of the Act requires that facilities achieving the lowest TPSs receive the largest payment reductions. In the CY 2014 ESRD PPS final rule (78 FR 72223 through 72224), we finalized a payment reduction scale for PY 2016 and future payment years: For every 10 points a facility falls below the minimum TPS, the facility would receive an additional 0.5 percent reduction on its ESRD PPS payments for PY 2016 and future payment years, with a maximum reduction of 2.0 percent. We did not propose any changes to this policy for the PY 2020 ESRD QIP.
Because we are not yet able to calculate the performance standards for each of the clinical measures, we are also not able to calculate a proposed minimum TPS at this time. We will publish the minimum TPS, based on data from CY 2016 and the first part of CY 2017, in the CY 2018 ESRD PPS final rule.
We sought comments on this proposal regarding our policy to determine payment reductions for PY 2020.
As we continue to refine the ESRD QIP's policies and measures, we are evaluating different methods of ensuring that facilities strive for continuous improvement in their delivery of care to patients with ESRD. We also seek to refine our scoring methodology in an effort to make it easier for facilities and the ESRD community to understand. For future rulemaking, we are considering several policies and measures, and we are seeking comments on each of these policies and measures.
As discussed in section IV.E.2.b.i. above, we proposed to adopt the Standardized Hospitalization Ratio (SHR) Clinical measure and calculate performance rates for that measure in accordance with NQF-endorsed, Measures Application Partnership reviewed specifications. Similarly, performance rates for the SRR and STrR will continue to be calculated in accordance with NQF-endorsed, Measures Application Partnership reviewed specifications. Stakeholders have expressed that for most standardized ratio measures, rates are easier to understand than ratios. (The exception is the NHSN BSI Clinical Measure, which is intentionally expressed as a ratio, and cannot be transformed into a rate without distorting the underlying results.) For future years of the QIP, we are considering a proposal to express the ratios as rates instead, for the SRR and STrR measures. Specifically, we would not propose any changes to the manner in which performance rates themselves are calculated, but would propose to calculate rates by multiplying the facility's ratio for each of these measures by the national raw rate of events (also known as the median), which is specific to the measure each year. We are also considering reporting national performance standards and individual facility performance rates as rates, as opposed to ratios, for these measures. Similarly, we are considering a proposal to use rates, as opposed to ratios, when calculating facility improvement scores for these measures.
In PY 2019, we proposed to adopt a patient-level influenza immunization reporting measure that could be used to calculate a future clinical measure based on either “ESRD Vaccination—Full-Season Influenza Vaccination” (Measures Application Partnership #XDEFM) or NQF #0226: “Influenza Immunization in the ESRD Population (Facility Level).” We continue to believe that it is important to include a clinical measure on patient-level influenza vaccination in the ESRD QIP. However, we did not propose to add a patient-level influenza immunization reporting measure into the ESRD QIP. Nevertheless, data elements were recently amended in CROWNWeb to support data collection for either of the two potential clinical measures on patient-level influenza (that is, Measures Application Partnership #XDEFM and NQF #0226). We will continue to collect these data and conduct detailed analyses to determine whether either of these clinical
As part of our effort to continuously improve the ESRD QIP, we are also working on developing additional, robust measures that provide valid assessments of the quality of care furnished to ESRD patients by ESRD facilities. Some measures we are considering developing for future inclusion in the ESRD QIP measure set include a Standardized Mortality Ratio (SMR) measure, a measure examining utilization of hospital Emergency Departments, a measure examining medication reconciliation efforts, and a measure examining kidney transplants in patients with ESRD.
We sought comments on these issues, including whether data for a patient-level influenza immunization clinical measure should be collected through CROWNWeb or through NHSN.
Despite support for the general concept, several commenters urged CMS to carefully consider the methodology used if it is decided to convert ratios to rates. They suggested that the use of the national median rate as the conversion factor would be potentially misleading in certain regions of the country where typical performance varies significantly from the national rate.
One commenter offered two simulations of possible methodologies to convert rates to ratios: First, using the median rate to convert the ratio to a rate; second, using the mean rate to convert the ratio to a rate. In both of these scenarios, QIP scores remained identical—dialysis facilities received the same scores regardless of the ratio or rate methodology. The commenter concluded that they would likely support this proposal but would need to see additional analyses regarding the methodology to be used.
Commenters also supported the proposal to use CROWNWeb to collect patient-level influenza clinical measure data, because KCQA specified and tested the patient-level influenza measure using facility data with the intention that such data would be submitted through CROWNWeb. They added that using NHSN would introduce another factor that would require reliability and validity testing as well as increasing the burden on dialysis facilities because of manual entry issues. They strongly recommended that if CMS does add a patient-level influenza immunization clinical measure, it should add NQF #0226 unchanged and collect the data through CROWNWeb.
Another commenter disagreed with CMS's concerns that NQF #0226 would exclude patients who die from influenza, but might not have died if they had been vaccinated. The measure specifications do not include such an exclusion and in fact the measure excludes unvaccinated patients who die prior to March 31. This exclusion does not penalize facilities for patients who could still have received a vaccination within the timeframe specified by the Agency's own measurement timeframe. The commenter recommended setting the denominator such that it is aligned with the NHSN protocol and NQF specifications and that CMS clearly state that the CDC would determine the date when a vaccine is made available each year.
Section 1847(a) of the Social Security Act (the Act), as amended by section 302(b)(1) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173), requires the Secretary of the Department of Health and Human Services (the Secretary) to establish and implement the Competitive Bidding Program (CBP) in Competitive Bidding Areas (CBAs) throughout the United States for contract award purposes for the furnishing of certain competitively priced Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) items and services. The programs, mandated by section 1847(a) of the Act, are collectively referred to as the “Medicare DMEPOS Competitive Bidding Program.” The 2007 DMEPOS competitive bidding final rule (Medicare Program; Competitive Acquisition for Certain DMEPOS and Other Issues published in the April 10, 2007
Section 1847(a)(1)(G) of the Act, as added by section 522(a) of the Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L. 114-10) (MACRA), now requires a bid surety bond for bidding entities. Section 1847(a)(1)(G) of the Act, as added by section 522(a) of MACRA, provides that, with respect to rounds of competitions under section 1847 beginning not earlier than January 1, 2017 and not later than January 1, 2019, a bidding entity may not submit a bid for a CBA unless, as of the deadline for bid submission, the entity has (1) obtained a bid surety bond, in the range of $50,000 to $100,000, in a form specified by the Secretary consistent with subparagraph (H) of section 1847(a)(1), and (2) provided the Secretary with proof of having obtained the bid surety bond for each CBA in which the entity submits its bid(s). Section 1847(a)(1)(H)(i) provides that in the event that a bidding entity is offered a contract for any product category for a CBA, and its composite bid for such product category and area was at or below the median composite bid rate for all bidding entities included in the calculation of the single payment amount(s) for the product category and CBA, and the entity does not accept the contract offered, the bid surety bond(s) for the applicable CBAs will be forfeited and CMS will collect on the bid surety bond(s). In instances where a bidding entity does not meet the bid forfeiture conditions for any product category for a CBA as specified in section 1847(a)(1)(H)(i) of the Act, then the bid surety bond liability submitted by the entity for the CBA will be returned to the bidding entity within 90 days of the public announcement of the contract suppliers for such product category and area.
Section 522 of MACRA further amended section 1847(b)(2)(A) of the Act by adding clause (v) to the conditions that a bidding entity must meet in order for the Secretary to award a contract to any entity under a competition conducted in a CBA to furnish items and services. Section 1847(b)(2)(A)(v) of the Act adds the requirement that the bidding entity must meet applicable State licensure requirements in order to be eligible for a DMEPOS CBP contract award. We note, however, that this does not reflect a change in policy as CMS already requires contract suppliers to meet applicable State licensure requirements in order to be eligible for a contract award.
The proposed rule, titled “End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care Model” (81 FR 42802 through 42880), was published in the
In this final rule, we provide a summary of each proposed provision, a summary of the public comments received and our responses to them, and the policies we are finalizing for the DMEPOS Competitive Bidding Program. Comments related to the paperwork burden are addressed in the “Collection of Information Requirements” section in this final rule. Comments related to the impact analysis are addressed in the “Economic Analyses” section in this final rule.
At proposed § 414.402, we proposed adding a definition for “bidding entity” to mean the entity whose legal business name is identified in the “Form A: Business Organization Information” section of the bid (81 FR 42877).
At proposed § 414.412, “Submission of bids under a competitive bidding program,” we proposed adding a new paragraph (h) that would allow CMS to implement section 1847(a)(1)(G) of the Act, as amended by section 522(a) of MACRA, to state that an entity may not
At proposed § 414.412(h)(2) “Bid Surety Bond requirements,” we proposed that a bid surety bond contain the following information: (1) The name of the bidding entity as the principal/obligor; (2) The name and National Association of Insurance Commissioners number of the authorized surety; (3) CMS as the named obligee; (4) The conditions of the bond as specified in the proposed rule at (h)(3); (5) The CBA covered by the bond; (6) The bond number; (7) The date of issuance; and (8) The bid bond value of $100,000 (81 FR 42879).
Section 1847(a)(1)(G) of the Act permits CMS to determine the amount of the bond within a range of $50,000 to $100,000. We proposed setting the bid surety bond amount at $100,000 for each CBA in which a bidding entity submits a bid (81 FR 42879). This requirement is intended to ensure that bidding entities accept a contract offer(s) when their composite bid(s) is at or below the median composite bid rate used in the calculation of the single payment amounts. The CBP has historically had a contract acceptance rate exceeding 90 percent, and we believe that this acceptance rate will increase with this rule. We considered whether a lower bid surety bond amount would be appropriate for a particular subset of suppliers, for example, small suppliers as defined by § 414.402, and therefore, specifically solicited comments on whether to establish a lower bid surety bond amount for certain types of suppliers (81 FR 42848).
Proposed § 414.412(h)(3) specifies conditions for forfeiture of the bid surety bond and return of the bond liability (81 FR 42879). Pursuant to section 1847(a)(1)(H) of the Act, when (1) a bidding entity is offered a contract for any product category in a CBA, (2) the entity's composite bid is at or below the median composite bid rate for all bidding entities included in the calculation of the single payment amounts for the product category and CBA, and (3) the entity does not accept the contract offer, then the entity's bid surety bond for that CBA will be forfeited and CMS will collect on it. When the bidding entity does not meet these forfeiture conditions, the bid bond liability will be returned within 90 days of the public announcement of the contract suppliers for the CBA. The provision at proposed § 414.412(h) requires CMS to notify a bidding entity when it does not meet the bid forfeiture conditions and as a result CMS will not collect on the bid surety bond (81 FR 42879).
We proposed that bidding entities that provide a falsified bid surety bond would be prohibited from participation in the current round of the CBP in which they submitted a bid and from bidding in the next round of the CBP. Additionally, offending suppliers would be referred to the Office of Inspector General and Department of Justice for further investigation. We also proposed that if we find that a bidding entity has accepted a contract offer and then breached the contract in order to avoid bid surety bond forfeiture, the breach would result in a termination of the contract and preclusion from the next round of competition in the CBP. These proposed penalties are included in proposed § 414.412(h)(4).
We sought comments on these proposals. We note that we did not receive any comments on whether a lower bid surety bond amount would be appropriate for a particular subset of suppliers, for example, small suppliers, as defined at § 414.402.
The comments and our responses to the comments for these proposals are set forth below.
We proposed to revise § 414.414(b)(3), “Conditions for awarding contracts,” to align with 1847(b)(2)(A) of the Act, as amended by section 522(b) of MACRA (81 FR 42848). The amendment to the Act states that “[t]he Secretary may not award a contract to any entity under the competition conducted in an [
We sought comments on these proposals. The comments and our responses to the comments regarding these proposals are set forth below.
We believe DMEPOS suppliers should have the option to appeal all actions that CMS may take for breaches of contract. As a result, we proposed revising § 414.423, Appeals Process for Termination of Competitive Bidding Contract, to expand the appeals process for suppliers who have been sent a notice of a breach of contract stating that CMS intends to take one or more of the actions described in § 414.422(g)(2) as a result of the breach (81 FR 42848). While we recognize that we have the authority to take one or more actions specified in § 414.422(g)(2), the current appeals process is available for one of those actions, specifically, contract termination. Therefore, the proposed revisions would expand § 414.423 to allow appeal rights for each action specified in § 414.422(g)(2) for a breach of contract (81 FR 42848). If a supplier's notice of breach of contract includes more than one breach of contract action CMS would take, and the supplier chooses to appeal more than one action, CMS would make separate decisions for each breach of contract action after reviewing the hearing officer's recommendation (81 FR 42849). We also proposed revisions to § 414.422(g)(2) to remove the breach of contract actions of (1) requiring a contract supplier to submit a corrective action plan; and (2)
Proposed revisions were made throughout § 414.423 to extend the appeals process to any breach of contract actions described in proposed § 414.422(g)(2) that we might take as a result of the breach, rather than just contract termination actions (81 FR 42849). We also proposed removing the references to termination throughout § 414.423 and instead cross-reference all of the breach of contract actions in proposed § 414.422(g)(2) (81 FR 42849).
In proposed revisions to § 414.423(a), we proposed deleting the language indicating that termination decisions made under this section are final and binding as this reference is not inclusive of all breach of contract actions, and the finality of a decision is correctly addressed in paragraph (k)(4) of this section (81 FR 42878).
In the proposed revisions to § 414.423(b)(1), we proposed deleting the phrase “either in part or in whole” because § 414.422(g)(1) specifies that any deviation from contract requirements constitutes a breach of contract (81 FR 42878). In addition, we proposed removing the requirement that the breach of contract notice to the supplier be delivered by certified mail from § 414.423(b)(1) to allow CMS the flexibility to use other secure methods for notifying suppliers (81 FR 42878). We also proposed changes to § 414.423 (b)(2)(i) and (ii) (81 FR 42878). The revised § 414.423(b)(2)(i) states that the notice of breach of contract would include the details of the breach of contract, while § 414.423(b)(2)(ii) requires CMS to include the action or actions that it is taking as a result of the breach of contract and the timeframes associated with each breach of contract action in the notice (81 FR 42878). For example, when a notice of breach of contract includes an action of preclusion, the effective date of the preclusion would be the date specified in the letter and the timeframe of the preclusion will specify the round of the CBP from which the supplier is precluded. We also proposed to add language to paragraph (b)(2)(vi) to specify that the effective date of the action or actions that CMS would take is the date specified by CMS in the notice of breach of contract, or 45 days from the date of the notice of breach of contract unless a timely hearing request has been filed or a CAP has been submitted within 30 days of the date of the notice of breach of contract where CMS allows a supplier to submit a CAP (81 FR 42878-79).
We proposed revising § 414.423(c)(2)(ii) to specify that the subsequent notice of breach of contract may, at CMS' discretion, allow the supplier to submit another written CAP pursuant to § 414.423(c)(1)(i) (81 FR 42879). We proposed to revise § 414.423(e)(3) to clarify that CMS retains the option to offer the supplier an opportunity to submit another CAP, if CMS deems appropriate, in situations where CMS has already accepted a prior CAP (81 FR 42879).
Proposed revisions to § 414.423(f)(5) explain that in the event the supplier fails to timely request a hearing, the breach of contract action or actions specified in the notice of breach of contract would take effect 45 days from the date of the notice of breach of contract (81 FR 42879). Proposed revisions to § 414.423(g)(3) were made to clarify that the hearing scheduling notice must be sent to all parties, not just the supplier (81 FR 42879).
We proposed revising § 414.423(j) to clarify that the hearing officer would issue separate recommendations for each breach of contract action in situations where there is more than one breach of contract action presented at the hearing (81 FR 42880).
In § 414.423(k), we proposed specifying that CMS would make separate decisions for each recommendation when the hearing officer issues multiple recommendations (81 FR 42880). In addition, we proposed revisions to this paragraph to expand CMS' final determination process, clarifying that the notice of CMS' decision would be sent to the supplier and the hearing officer and would indicate whether any breach of contract actions included in the notice of breach of contract still apply and will be effectuated, and would indicate the effective date of the breach of contract action, if applicable (81 FR 42880). We also proposed expanding on § 414.423(l), effect of breach of contract action or actions, to specify effects of all contract actions described in § 414.422(g)(2) (81 FR 42880). In addition, we proposed adding proposed § 414.423(l)(1), effect of contract suspension, to outline the supplier's requirements regarding furnishing items and reimbursement for the duration of the contract suspension, as well as the details regarding the supplier's obligation to notify beneficiaries (81 FR 42880). We also proposed adding proposed § 414.423(l)(3) (81 FR 42880), effect of preclusion, to specify that a supplier who is precluded would not be allowed to participate in a specific round of the CBP, which would be identified in the original notice of breach of contract. Additionally, we proposed adding proposed § 414.423(l)(4), effect of other remedies allowed by law, to state if CMS decides to impose other remedies under § 414.422(g)(2)(iv), the details of the remedies would be included in the notice of breach of contract (81 FR 42880). Proposed § 414.423(l) also specifies the steps suppliers must take to notify beneficiaries after CMS takes the contract action or actions described in § 414.422(g)(2) (81 FR 42880). Lastly, we proposed to remove language from § 414.423(l)(2), effect of contract termination, to avoid confusion as to which supplier is providing notice to the beneficiary (81 FR 42880).
We sought comments on these proposals. The comments and our responses to the comments regarding these proposals are set forth below.
In the final rule we are also making a revision to § 414.402, Definitions, for the term “hearing officer”. In the revised definition, we are removing the references to “termination” and replacing those references with “breach of contract” to align with the final changes to § 414.423 that we are adopting in this final rule, as well as deleting the abbreviation “(HO)”, which is no longer used in § 414.423 As we discuss in section XII. “Waiver of Proposed Rulemaking,” because these revisions to § 414.202 are technical in nature, to align the definition of hearing officer with the terminology and process finalized in § 414.423, we find good cause to waive notice and comment rulemaking for this definition revision.
Section 1834(a) of the Social Security Act (the Act) governs payment for durable medical equipment (DME) covered under Part B and under Part A for a home health agency and provides for the implementation of a fee schedule payment methodology for DME furnished on or after January 1, 1989. Sections 1834(a)(2) through (a)(7) of the Act set forth separate payment categories of DME and describe how the fee schedule for each of the following categories is established:
• Inexpensive or other routinely purchased items;
• Items requiring frequent and substantial servicing;
• Customized items;
• Oxygen and oxygen equipment;
• Other covered items (other than DME); and
• Other items of DME (capped rental items).
Section 1834(h) of the Act governs payment for prosthetic devices, prosthetics, and orthotics (P&O) and sets forth fee schedule payment rules for P&O. Effective for items furnished on or after January 1, 2002, payment is also made on a national fee schedule basis for parenteral and enteral nutrition (PEN) in accordance with the authority under section 1842(s) of the Act. The term “enteral nutrition” will be used throughout this document to describe enteral nutrients, supplies and equipment covered as prosthetic devices in accordance with section 1861(s)(8) of the Act and paid for on a fee schedule basis and enteral nutrients under the Medicare DMEPOS Competitive Bidding Program (CBP), as authorized under section 1847(a)(2)(B) of the Act. Additional background discussion about DMEPOS items subject to section 1834 of the Act, rules for calculating reasonable charges, and fee schedule payment methodologies for PEN and for DME prosthetic devices, prosthetics, orthotics, and surgical dressings, was provided in the July 11, 2014 proposed rule at 79 FR 40275 through 40277.
Section 1847(a) of the Act, as amended by section 302(b)(1) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173), requires the Secretary to establish and implement CBPs in competitive bidding areas (CBAs) throughout the United States for contract award purposes for the furnishing of certain competitively priced DMEPOS items and services. The programs mandated by section 1847(a) of the Act are collectively referred to as the “Medicare DMEPOS Competitive Bidding Program.” Section 1847(a)(2) of the Act provides that the items and services to which competitive bidding applies are:
• Off-the-shelf (OTS) orthotics for which payment would otherwise be made under section 1834(h) of the Act;
• Enteral nutrients, equipment and supplies described in section 1842(s)(2)(D) of the Act; and
• Certain DME and medical supplies, which are covered items (as defined in section 1834(a)(13) of the Act) for which payment would otherwise be made under section 1834(a) of the Act.
The DME and medical supplies category includes items used in infusion and drugs (other than inhalation drugs) and supplies used in conjunction with DME, but excludes class III devices under the Federal Food, Drug, and Cosmetics Act and Group 3 or higher complex rehabilitative power wheelchairs and related accessories when furnished with such wheelchairs. Sections 1847(a) and (b) of the Act specify certain requirements and conditions for implementation of the Medicare DMEPOS CBP.
Below is a summary of the three general methodologies used in adjusting payment amounts for DMEPOS items in areas that are not CBAs using information from the DMEPOS CBP.
Section 1834(a)(1)(F)(ii) of the Act provides the Secretary with the authority to use information from the DMEPOS CBPs to adjust the DME payment amounts for covered items furnished on or after January 1, 2011, in areas where competitive bidding is not implemented for the items. Similar authority exists at section 1834(h)(1)(H)(ii) of the Act for OTS orthotics. Also, section 1842(s)(3)(B) of the Act provides authority for making adjustments to the fee schedule amounts for enteral nutrients, equipment, and supplies (enteral nutrition) based on information from CBPs. Section 1834(a)(1)(F)(ii) of the Act also requires adjustments to the payment amounts for all DME items subject to competitive bidding furnished in areas where CBPs have not been implemented on or after January 1, 2016.
For items furnished on or after January 1, 2016, section 1834(a)(1)(F)(iii) of the Act requires us to continue to make such adjustments to DME payment amounts where CBPs have not been implemented as additional covered items are phased in or information is updated as contracts are re-competed. Section 1834(a)(1)(G) of the Act requires that the methodology used to adjust payment amounts for DME and OTS orthotics using information from the CBPs be promulgated through notice and comment rulemaking. Also, section 1834(a)(1)(G) of the Act requires that we consider the “costs of items and services in areas in which such provisions [sections 1834(a)(1)(F)(ii) and 1834(h)(1)(H)(ii)] would be applied compared to the payment rates for such items and services in competitive acquisition [competitive bidding] areas.”
Pursuant to § 414.210(g)(1), CMS determines a regional price for DME items or services for each state in the contiguous United States and the District of Columbia equal to the un-weighted average of the single payment amounts (SPAs) for an item or service for CBAs that are fully or partially located in the same region that contains the state or the District of Columbia. CMS uses the regional prices to determine a national average price equal to the un-weighted average of the regional prices. The regional SPAs (RSPAs) cannot be greater than 110 percent of the national average price (national ceiling) or less than 90 percent of the national average price (national floor). This methodology applies to enteral nutrition and most DME items furnished in the contiguous United States (that is, items that are included in more than 10 CBAs).
The fee schedule amounts for areas defined as rural areas for the purposes of the CBP are adjusted to 110 percent of the national average price described above. The regulations at § 414.202 define a rural area to mean, for the purpose of implementing § 414.210(g), a geographic area represented by a postal zip code if at least 50 percent of the total geographic area of the area included in the zip code is estimated to be outside any metropolitan area (MSA). A rural area also includes a geographic area represented by a postal zip code that is a low population density area excluded from a CBA in accordance with the authority provided by section 1847(a)(3)(A) of the Act at the time the rules at § 414.210(g) are applied.
Pursuant to § 414.210(g)(2), in areas outside the contiguous United States (that is, noncontiguous areas such as Alaska, Guam, and Hawaii), the fee schedule amounts are reduced to the greater of the average of SPAs for the item or service for CBAs outside the contiguous United States (currently only applicable to Honolulu, Hawaii) or the national ceiling amounts calculated for an item or service based on RSPAs for CBAs within the contiguous United States.
Pursuant to § 414.210(g)(3), for DME items included in ten or fewer CBAs, the fee schedule amounts for the items are reduced to 110 percent of the un-weighted average of the SPAs from the ten or fewer CBAs. This methodology applies to all areas within and outside the contiguous United States.
Section 1834(a)(1)(F)(ii) of the Act requires the Secretary to use information from the CBP to adjust the DMEPOS payment amounts for items furnished on or after January 1, 2016, and section 1834(a)(1)(F)(iii) requires the Secretary to continue to make such adjustments as additional covered items are phased in or information is updated as competitive bidding contracts are recompeted. In accordance with § 414.210(g)(8), the adjusted fee schedule amounts are revised when an SPA for an item or service is updated following one or more new competitions and as other items are added to CBPs. DMEPOS fee schedule amounts that are adjusted using SPAs will not be subject to the annual DMEPOS covered item update and will only be updated when SPAs from the CBP are updated. Updates to the SPAs may occur at the end of a contract period as contracts are recompeted, as additional items are added to the CBP, or as new CBAs are added. In cases where adjustments to the fee schedule amounts are made using any of the methodologies described above, and the adjustments are based solely on the SPAs from CBPs that are no longer in effect, the SPAs are updated before being used to adjust the fee schedule amounts. The SPAs are adjusted based on the percentage change in the Consumer Price Index for all Urban Consumers (CPI-U) over the course of time described in § 414.210(g)(4). For example, if the adjustments were to be effective January 1, 2017, the SPAs from CBPs no longer in effect would be updated based on the percentage change in the CPI-U from the mid-point of the last year the SPAs were in effect to June 30, 2016, the month ending 6 months prior to the date the initial fee schedule reductions go into effect. Following the initial adjustment, if the adjustments continue to be based solely on the SPAs that are no longer in effect, the SPAs will be updated every 12 months using the CPI-U for the 12-month period ending 6 months prior to the date the updated payment adjustments would go into effect.
In our CY 2015 final rule (79 FR 66263), we adopted a method to address unbalanced bidding, which is a situation that results in price inversions under CBPs. We added § 414.210(g)(6) to the regulations for certain limited situations where bidding for similar but different enteral infusion pumps and standard power wheelchairs resulted in the SPAs for higher utilized items with additional features (for example, an enteral infusion pump with an alarm or a Group 2 power wheelchair) being less than the SPAs for lower utilized items without those additional features (for example, an enteral infusion pump without an alarm or Group 1 power wheelchair). A Group 2 power wheelchair is faster, travels further, and climbs higher obstacles than a Group 1 power wheelchair. Under CBPs, when similar items with different features are included in the same product category, the HCPCS code with higher beneficiary utilization at the time of the competition receives a higher weight and the bid for this item has a greater impact on the supplier's composite bid as well as the competitiveness of the supplier's overall bid for the product category (PC) within the CBP as compared to the bid for the less frequently utilized item. If, at the time the competition takes place under the CBP, the item with the additional features is priced higher and over time is utilized more than the other similar items without these features, it could result in unbalanced bidding, which in turn causes the item without the additional features to receive a higher single payment amount under the CBP than the item with the additional features. This situation results in a price inversion, where the higher weighted and higher priced item at the time of the competition becomes the lower priced item in the CBP following the competition. Unbalanced bidding can occur when a bidder has a higher incentive to submit a lower bid for one item than another due to the fact that the item has a higher weight and therefore a greater effect on the supplier's composite bid for the product category than the other item. Our current regulation at § 414.210(g)(6) for adjusting DMEPOS fee schedule amounts paid in non-CBAs using information from CBPs includes methodologies to address price inversions for power wheelchairs and enteral infusion pumps only. This rule limits SPAs for items without additional features (for example, an enteral infusion pump without an alarm) to the SPAs for items with the additional features (for example, an enteral infusion pump with an alarm) prior to using these SPAs to adjust fee schedule amounts.
For example, if most of the utilization or allowed services for standard power wheelchairs are for higher paying Group 2 wheelchairs than Group 1 wheelchairs at the time the competition occurs, the bids for the Group 2 wheelchairs have a greater impact on the supplier's composite bid and chances of being offered a contract. Therefore the supplier has a much greater incentive to make a lower bid for the Group 2 wheelchairs relative to the fee schedule payment than they do for the Group 1 wheelchairs. If, for example, Medicare is paying $450 per month for a Group 2 wheelchair at the time of the competition and a Group 2 wheelchair has a high weight, while Medicare is paying $350 per month for the Group 1 version of the same wheelchair at the time of the competition and the Group 1 wheelchair has a very low weight, the bids for the two items could be unbalanced or inverted whereby the bid submitted for the Group 2 wheelchair is $250 (44 percent below the fee schedule amount for the item) while the bid submitted for the Group 1 wheelchair is $300 (14 percent below the fee schedule amount for the item). A price inversion therefore results where Medicare previously paid $450 for one item and now pays $250, and previously paid $350 for another item for which it now pays $300. The item weight under the CBP results in Medicare paying more for a Group 1 power wheelchair than a higher-performing Group 2 power wheelchair.
In the CY 2015 proposed rule published on July 11, 2014 in the
The proposed rule, titled “End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care Model” (81 FR 42802 through 42880), was published in the
In the proposed rule, for the Method for Adjusting DMEPOS Fee Schedule Amounts for Similar Items with
After performing a review of all HCPCS codes in the CBPs in order to comply with our commitment to consider whether to apply the regulation at § 414.210(g)(6) to other cases of price inversion that resulted from unbalanced bidding that were not identified or addressed in the CY 2015 final rule (79 FR 66231), we found a significant number of price inversions resulting from the 2016 DMEPOS CBP Round 2 Recompete for contract periods beginning July 1, 2016. The items affected included transcutaneous electrical nerve stimulation (TENS) devices, walkers, hospital beds, power wheelchairs, group 2 support surfaces (mattresses and overlays), enteral infusion pumps, and seat lift mechanisms. As a result of our review, we proposed a rule that would expand the provisions of § 414.210(g)(6) to address these and other price inversions.
To perform our review, we examined instances within the HCPCS where there are multiple codes for an item (for example, a walker) that are distinguished by the addition of features (for example, folding walker versus rigid walker or wheels versus no wheels) which may experience price inversions. Our review included all groupings of similar items with different features within each of the product categories. We have included the HCPCS codes describing groupings of similar items that would be subject to this final rule and the features associated with each code below:
As shown in Table 20, under the 2015 DMEPOS fee schedule, Medicare pays more for walkers with wheels than walkers without wheels. The same is true for walkers that fold as compared to walkers that do not fold. Walkers that are rigid and do not fold are very rarely used and have extremely low utilization, and a walker that folds and has wheels is used much more frequently than a walker that folds but does not have wheels.
Under the DMEPOS CBP, because the folding walker without wheels (E0135) are used more frequently than the rigid walker without wheels (E0130), code E0135 receives a higher weight than code E0130. In addition, under the 2015 fee schedule, Medicare pays more for code E0135 than code E0130. Weights are assigned to individual items (HCPCS codes) within a product category (for example, standard mobility equipment) under the DMEPOS CBP for the purpose of calculating a composite bid for each supplier submitting bids for that product category in a CBA. The weights are based on the beneficiary utilization rate using national data when compared to other items in the same product category. The beneficiary utilization rate of an item captures the total allowed services for the item from Medicare claims submitted for the item on a national basis. A supplier's bid for each item in the product category is multiplied by the weight assigned to the item, and the sum of these calculations equals the supplier's composite bid. Contracts are offered to eligible suppliers with the lowest composite bids. Therefore, the higher the weight for an item in a product category, the more the bid for that item will affect the supplier's composite bid and chances of being offered a contract for that product category. Conversely, the lower the weight for an item in a product category, the less the bid for that item will affect the supplier's composite bid and chances of being offered a contract for that product category.
Similarly, because the folding walker with wheels (E0143) is used more frequently than the rigid walker with wheels (E0141), and more frequently than the walkers without wheels (E0130 and E0135), it receives a higher weight under the DMEPOS CBP than all three codes for the less expensive, less frequently utilized codes with fewer features: Codes E0130, E0135, and E0141. Under the 2015 fee schedule, Medicare pays more for code E0143 than codes E0130 (rigid walkers without wheels), E0135 (folding walkers without wheels) or E0141 (rigid walkers with wheels). Under the Round 2 Recompete, the fact that code E0143 (folding walkers with wheels) received a far greater weight than the other walkers that either did not fold, did not have wheels, or had neither feature resulted in price inversions as illustrated in Table 21. The first price inversion involves a rigid walker without wheels (E0130). A rigid walker without wheels has lower fee schedule amounts on average and a lower weight than a folding walker without wheels (E0135), yet under competitive bidding, it has a greater SPA than the folding walker. The second price inversion involves a rigid walker with wheels (E0141), which has lower fee schedule amounts on average and a lower weight than a folding walker with wheels (E0143), but has a greater SPA than the folding walker with wheels under competitive bidding. The third price inversion involves a rigid walker without wheels (E0130), which has a greater SPA than a folding walker with wheels despite having lower fee schedule amounts on average and a lower weight than the folding walker with wheels (E0143).
In all cases, Medicare pays a higher payment for walkers with wheels than walkers without wheels under the fee schedule. This differential in payment amounts is significant because it reflects the fact that the walker with wheels has a feature that likely resulted in higher fee schedule amounts for this item, making it more costly than the same type of walker without the addition of wheels. Rather than defining the ability of a walker to fold or the presence of wheels as a “hierarchal” feature, it can simply be noted that under the fee schedule, Medicare pays more for walkers with the ability to fold than walkers without the ability to fold and that Medicare pays more for walkers with wheels than for walkers without wheels.
If the items with additional features are more expensive and are also utilized more than the items without the features, a price inversion can result in a CBA due to the item weights and how they factor into the composite bids, as described above. Therefore, we proposed to adopt a definition of price inversion in our regulations at proposed § 414.402 as any situation where the following occurs: (a) One item (HCPCS code) in a grouping of similar items (for example, walkers, enteral infusion pumps, or power wheelchairs) in a product category includes a feature that another, similar item in the same product category does not have (for example, wheels, an alarm, or Group 2 performance); (b) the average of the 2015 fee schedule amounts (or initial, unadjusted fee schedule amounts for subsequent years for new items) for the code with the feature is higher than the average of the 2015 fee schedule amounts for the code without the feature; and (c) following a competition, the SPA for the code with the feature is lower than the SPA for the item without
The first method we considered for addressing price inversions (method 1) uses the methodologies at 42 CFR 414.210(g)(6) and limits the SPA for the code without the feature to the SPA for the code with the feature before the SPA is used to adjust the fee schedule amounts for the item (81 FR 42854). For example, under the Round 2 Recompete, the SPA for code E0141 for the South Haven-Olive Branch, MS CBA is $106.52. Code E0143 describes the same type of walker, but code E0143 walkers fold, while code E0141 walkers are rigid and do not fold. However, under the Round 2 Recompete, the SPA for code E0143 (wheeled walkers that fold) for the South Haven-Olive Branch, MS CBA is $44.00, or $62.52 less than the SPA for E0141 (wheeled walkers that do not fold). The average of the 2015 fee schedule amounts for codes E0141 and E0143 are $107.89 and $111.69, respectively. Altogether, since (a) one walker in a product category includes a feature that another, similar walker in the same product category does not have (in this situation, the ability to fold); (b) the average of the 2015 fee schedule amounts for the folding walker (E0143) is higher than the average of the 2015 fee schedule amounts for the rigid walker (EO141); and (c) the SPA for the folding walker ($44.50) is lower than the SPA for the rigid walker ($106.52), these items would meet the proposed definition of a price inversion under the DMEPOS CBP. Under method 1, the SPA of $106.52 for code E0141 in this CBA would be adjusted to the SPA of $44.00 for code E0143 in this CBA, so that $44.00, rather than $106.52, would be used for this CBA in computing the regional price for code E0141 described in § 414.210(g)(1)(i) under the method used to adjust the fee schedule amounts for code E0141. To further illustrate how method 1 would work, the 2016 SPAs for codes E0130, E0135, E0141, and E0143 for the Akron, Ohio CBA, and the amounts they would be adjusted to before applying the fee schedule adjustment methodologies are listed in Table 22 below.
The method 1 approach is currently used for enteral infusion pumps and standard power wheelchairs at § 414.210(g)(6), and each price inversion correction is made for a set of two items, as described in the regulation. For example, § 414.210(g)(6)(ii) states that in situations where a single payment amount in a CBA for a Group 1, standard, sling/solid seat and back power wheelchair is greater than the single payment amount in the same CBA for a Group 2, standard, sling/solid seat and back power wheelchair, the single payment amount for the Group 1, standard, sling/solid seat and back power wheelchair is adjusted to be equal to the single payment amount for the Group 2, standard, sling/solid seat and back power wheelchair prior to applying the payment adjustment methodologies in the section. We stated in the proposed rule that, if method 1 is finalized, we would indicate that additional price inversions involving additional sets of two items to which this rule would apply would be identified in a table in the preamble of the final rule (81 FR 42854). An example of such a table is provided below in Table 23 using codes for walkers, seat lift mechanisms, and TENS devices:
The second method we considered and proposed (method 2) would limit the SPAs in situations where price inversions occur so that the SPAs for all of the similar items, both with and without certain features, are limited to the weighted average of the SPAs for the items based on the item weights assigned under competitive bidding (81 FR 42855). This approach would factor in the supplier bids for the lower volume and higher volume items. This would establish one payment for similar types of items that incorporates the volume and weights for items furnished
The item weights from the Round 2 Recompete for the four walker codes in this subcategory of walkers in the table above are 0.1 percent for E0130, 4.8 percent for E0135, 0.5 percent for E0141, and 94.6 percent for E0143. The weighted average of the SPA for the four walker codes would be $45.53 ($51.62 × 0.001 + $47.65 × 0.048 + $81.62 × 0.005 + $45.22 × 0.946). This weighted average SPA would be used to adjust the fee schedule amounts for these four codes rather than simply limiting the SPAs for E0135 and E0143 in Table 16 above. This method uses item weights in a product category to adjust the SPA before making adjustments to the fee schedule amount. In accordance with the proposed definition of a price inversion, (a) E0135 and E0143 include features that other, similar walkers in the same product category do not (the ability to fold); (b) the average of the 2015 fee schedule amounts for the folding walkers (E0135 & E0143) are higher than the average of the 2015 fee schedule amounts for the rigid walkers (E0130 & E0141); and (c) the 2016 SPAs for the folding walkers were less than the SPAs for the respective rigid walkers. Therefore, the SPA for code E0130 is higher than the SPA for code E0135, the SPAs for codes E0141 and E0143 were inverted such that the SPA for code E0141 is higher than the SPA for code E0143, and the SPAs for codes E0135 and E0143 were inverted such that the SPA for code E0135 is higher than the SPA for code E0143. Under the proposed method 2, these three price inversions would be addressed so that the SPAs for all of the similar items described by codes E0130, E0135, E0141, and E0143 in this CBA would be adjusted to the weighted average of the SPAs for these codes for similar items in this CBA. As a result, the adjusted SPA of $45.53 rather than $51.62, $47.65, $81.62, and $45.22, would be used to compute the regional price for codes E0130, E0135, E0141, and E0143, respectively, using method 2 to adjust the fee schedule amounts for these items and in accordance with § 414.210(g)(1)(i).
Although we believe that both method 1 and method 2 would correct inverted SPAs, method 1 simply limits the amount paid for the item without a feature(s) to the item with the feature(s), while method 2 factors in the SPAs for all of the items. Therefore, if the cost of an item without a feature was actually more than the cost of an item with a feature (for example, for volume discounts for the item with the feature drives the price down below the price for the item without the feature), method 1 would not allow the higher cost of the item without the feature to be factored into the payment made to the suppliers of the items. Therefore, we proposed to use method 2 because it took into account the supplier bids for all of the similar items when establishing the payment amounts used to adjust fees; and therefore, factors in contemporary information relative to bids and supplier information for various items with different features and costs (81 FR 42855). The SPAs established based on supplier bids for all of the similar items are used to calculate the weighted average. If, for some reason, the market costs for an item without a feature are actually higher than the market costs for an item with the feature, due to economies of scale, supply and demand, or other economic factors, these costs are accounted for in the weighted average of the SPAs established for each of the similar items. Under method 1, the SPA for the lower weight item without a feature is limited to the SPA for the higher weight item with the feature, and so potential cost inversions driven by market forces or supplier costs are not accounted for in establishing the adjusted payment amounts. We solicited comments on both method 2, which we proposed, and method 1, which we considered.
In summary, we proposed to expand use of the method at § 414.210(g)(6) to other situations where price inversions occur under CBPs. First, we proposed to revise 42 CFR 414.402 to add the definition of price inversion as any situation where the following occurs (81 FR 42856, 42877):
• One item (HCPCS code) in a grouping of similar items (for example, walkers, enteral infusion pumps or power wheelchairs) in a product category includes a feature that another, similar item in the same product category does not have (for example, wheels, alarm, or Group 2 performance);
• The average of the 2015 fee schedule amounts (or initial, unadjusted fee schedule amounts for subsequent years for new items) for the code with the feature is higher than the average of the 2015 fee schedule amounts for the code without the feature; and
• The SPA in any year after and including 2016 for the code with the feature is lower than the SPA for the code without that feature.
Second, we proposed to revise § 414.210(g)(6) to specify that, in situations where price inversions occur under a CBP, the SPAs for the items would be adjusted before applying the fee schedule adjustment methodologies under § 414.210(g) (81 FR 42877). We proposed that the adjustments to the SPAs would be made using method 2 described above (81 FR 42855). We also proposed changes to the regulation text at § 414.210(g)(6) to reflect use of method 2 to adjust the SPAs for all of the similar items where price inversions have occurred, both with and without certain features, so that they are limited to the weighted average of the SPAs for
We solicited comments on the method for adjusting DMEPOS fee schedule amounts for similar items with different features using information from competitive bidding programs and received 8 public comments on our proposals, including comments from DMEPOS manufacturers and suppliers.
The comments and our responses to the comments for these proposals are set forth below.
Establishing single payment amounts based on the median of bids (as opposed to the highest bid) is applied consistently to each item in the product category and reflects the bids of all of the winning suppliers rather than just one. It is also similar to how the DME fee schedule amounts were initially established for each item, either based on average reasonable charges or average supplier prices (as opposed to the highest charge or price). We fail to see how establishing SPAs under the CBP using median bid amounts is an underlying cause of price inversions. We believe that use of composite bids is necessary when a competition under the CBP is for a group of items versus a single item. It is the method used to determine which bids are the most competitive (that is, generate the most savings) for the items in the product category as a whole. Use of a composite bid would not be necessary if the competition under the program were for a single item (for example, for one HCPCS code for oxygen and oxygen equipment used to bill and receive payment for all items and services furnished on a monthly basis related to oxygen and oxygen equipment). Therefore, we do not believe price inversions are caused by use of composite bids and item weights alone. Based on our analysis and the examples we discussed previously, we believe the problem results when there are multiple codes for items that can be substituted for one another because they serve the same general purpose (for example, standard power wheelchairs), but have different item weights that may vary significantly. As discussed in the proposed rule, price inversions result under the CBP when different item weights are assigned to similar items with different features within the product category. To prevent this from occurring under future competitions, we proposed, and as discussed in this final rule, an alternative “lead item” bidding method addressed in the section on submitting bids and determining single payment amounts for certain groupings of similar items with different features under the DMEPOS CBP (81 FR 42862).
In the interim period before this new bidding method, which we are adopting in this final rule, can be implemented, we must maintain the current contracts and payment amounts currently in effect, as required by section 1847(a) of the Act. We do not believe that other changes are necessary to address price inversions during this interim period. Under the final regulation, we will adjust inverted SPA prices prior to adjusting the fee schedule amounts for items that have been specifically listed in the rule.
We do not believe that a definition of product feature(s) is needed because we believe that situations where one item includes a certain feature and another item does not include that feature is clear, and generally Medicare should not pay more for the item without the feature than with a feature under any circumstances. Items without features should be paid less or equal to an item with a feature because the addition of a feature adds value to an item. We believe, for example, the Medicare payment rate for a non-electric hospital bed with side rails and mattress should not be higher than the payment rate for a semi-electric hospital bed with side rails and mattress. The Medicare program would be paying more for less features such as the non-electric bed. Likewise, we believe the Medicare payment rate for a semi-electric hospital bed without a mattress should not be higher than the Medicare payment rate for a semi-electric hospital bed with a mattress.
We do not believe that establishing smaller “subgroupings” of items is necessary because the groupings of items, relate to the items where existing price inversions have been identified for two or more of the codes in at least one CBA. In some cases, a code in a grouping may not be involved in a price inversion with another code in the grouping, and no adjustment is therefore necessary to adjust the difference in the SPAs for the two codes. In the case of heavy duty hospital beds, we have not determined that any price inversions have occurred where the SPA for a standard weight bed exceeds the SPA for a heavy duty version of the same bed. As such, there would be no situation where an SPA for a heavy duty bed will be adjusted using a weighted average of an SPA for a standard weight bed and an SPA for a heavy duty bed. The price inversions that have occurred for heavy duty beds within the grouping of codes for hospital beds have involved situations where the SPA for a heavy duty bed without a mattress is higher than the SPA for the same type of heavy duty bed with a mattress (the exact same feature). The changes we are finalizing to the regulation for addressing this situation are to adjust the SPAs for both heavy duty beds based on the weighted average of the SPAs for both heavy duty beds. The SPAs for standard weight beds would not be affected by this adjustment. Therefore, we are finalizing as we proposed.
Medicare pays for most DMEPOS furnished after January 1, 1989, pursuant to fee schedule methodologies set forth in sections 1834 and 1842 of the Social Security Act (the Act). Specifically, subsections (a) and (h) of section 1834 and subsection (s) of section 1842 of the Act provide that Medicare payment for these items is equal to 80 percent of the lesser of the actual charge for the item or a fee schedule amount for the item. The regulations implementing these provisions are located at 42 CFR part 414, subparts C and D.
Section 1847(a) of the Act, as amended by section 302(b)(1) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173), requires the Secretary to establish and implement CBPs in competitive bidding areas (CBAs) throughout the United States for contract award purposes for the furnishing of certain competitively priced DMEPOS items and services. Section 1847(b)(5) of the Act directs the Secretary to base the SPA for each item or service in each CBA on the bids submitted and accepted in the CBP. For competitively bid items, the SPAs have replaced the fee schedule payment methodology. Section 1847(b)(5) of the Act provides that Medicare payment for these competitively bid items and services is made on an assignment-related basis and is equal to 80 percent of the applicable SPA, less any unmet Part B deductible described in section 1833(b) of the Act. Section 1847(b)(2)(A)(iii) of the Act prohibits the Secretary from awarding a contract to an entity in a CBA unless the Secretary finds that the total amounts to be paid to contractors in a CBA are expected to be less than the total amounts that would otherwise be paid. This requirement aims to guarantee savings to both the Medicare program and its beneficiaries.
We implemented CBPs in 9 Round 1 metropolitan statistical areas on January 1, 2011, and an additional 91 Round 2 metropolitan statistical areas on July 1, 2013. Bids are submitted during a 60-day bidding period allowing suppliers adequate time to prepare and submit
The proposed rule, titled “End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care Model” (81 FR 42802 through 42880), was published in the
For each grouping of similar items, we proposed that the supplier's bid for the lead item would be used as the basis for calculating the SPAs for the other items within that grouping, based on the ratio of the average of the fee schedule amounts for each item for all areas nationwide in 2015, to the average of the fee schedule amounts for the lead item for all areas nationwide in 2015 (81 FR 42859, 42878). In proposed § 414.412(d)(2), we proposed to use the fee schedule amounts for 2015 for the purpose of maintaining the relative difference in fee schedule amounts for the items in each grouping as it existed prior to any adjustments being made to the amounts based on information from the CBPs (81 FR 42877). This is to avoid the impact of price inversions that have occurred in pricing items under the CBP from affecting the relative difference in fee schedule amounts for the items. Under the CBP, we found price inversions for groupings of similar items within the following categories: Standard power wheelchairs, walkers, hospital beds, enteral infusion pumps, TENS devices, support surface mattresses and overlays and seat lift mechanisms. These groupings of similar items are a subset of similar items with different features identified in this rule, as opposed to entire product categories.
Under the proposed lead item bidding method, a supplier submits one bid amount for furnishing all of the items in the grouping (for example, standard power wheelchairs), rather than submitting bid amounts for each individual HCPCS code describing each different item (81 FR 48259). The competitive bidding item in this case (for example, standard power wheelchairs) is a combination of HCPCS codes (for example, K0813 thru K0829) for power wheelchairs with different features (Group 1/Group 2, portable/standard weight/heavy duty weight/very heavy duty weight/extra heavy duty weight, sling seat/captains chair). Suppliers submitting bids under the method will understand that if their bid is in the winning range, it would be used to establish the single payment amounts for all of the codes in the grouping. Suppliers will therefore take into account the cost of furnishing all of the items described by the various codes when determining their bid amount for the lead item. Thus, to avoid cases of price inversions, the supplier is submitting a bid for an item (for example, standard power wheelchair), and for lead item bidding purposes, an “item” is a product that is identified by a combination of codes, as described in § 414.402. We also believe that the proposed lead item bidding method would greatly reduce the burden on suppliers of formulating and submitting multiple bids for similar items because it would require less time to enter their bids and would reduce the chances of keying errors when submitting bids. The lead item bidding method is intended to prevent future price inversions for a grouping of similar items, including codes for items (for example, total electric hospital beds) where price inversions have not occurred thus far, but where we believe price inversions would be likely based on information about the fee schedule amounts and the utilization of these items. By applying the lead item bidding method to all hospital beds, including total electric hospital beds, this prevents price inversions from occurring for all hospital beds. We also believe it is a more efficient method for implementing CBPs and pricing.
To identify the lead item, we proposed using allowed services from calendar year 2012 for the first time this bidding method is used for specific items in specific CBAs (81 FR 42859). We did not observe price inversions under the Round 1 competitions and contracts that were in effect from January 2011 through December 2013. The price inversions began with the Round 2 competitions and contracts that began on July 1, 2013; therefore, we proposed using data for allowed services from calendar year 2012 to ensure that the effects of price inversions do not impact the utilization of the various items that is used to identify the lead item. Once this bidding method has been used in all competitions for an item (for example, standard power wheelchairs), we proposed that the lead item would be identified for future competitions based on allowed services for the items at the time the subsequent competitions take place rather than the allowed services from calendar year 2012. For example, using allowed services from calendar year 2012 is necessary to identify the lead items initially since utilization of items for years subsequent to 2012 could be affected by the price inversions that began with the Round 2 competitions and contracts on July 1, 2013. Once the lead item bidding method is implemented for a grouping of similar items, and the price inversions are eliminated, utilization of items for years subsequent to the point at which the price inversions are eliminated can be used for the purpose of identifying the lead item because they would not be affected by price inversions. This will also help to prevent price inversions in adjusted fee schedule amounts using competitive bidding SPAs. We proposed to announce which items would be subject to this bidding method at the start of each competition in each CBA where
The following Tables 26, 27, and 28 show how the lead item for three groupings of similar items (standard power wheelchairs, walkers, and hospital beds, respectively) would be identified using 2012 allowed services and how the SPAs would be established based on the method described above. Under the proposal, when bidding for the lead item, a supplier is bidding to furnish the entire grouping of similar items. In the tables below, the lead items identified would be the lead items in initial competitions where the lead item bidding method is used. The first proposed category for lead item bidding is standard power wheelchairs (81 FR 42860).
Rather than submitting 14 individual bids for each of the 14 items, the supplier would submit one bid for the lead item. The SPA for lead item K0823 would be based on the median of the bids for this code, following the rules laid out in § 414.416(b) and for calculating rental amounts pursuant to § 414.408(h)(2). The SPAs for the other items would be based on the relative difference in fees for the other items as compared to the lead item. For example, if the SPA for code K0823 is $300.00, the SPA for code K0825 would be equal to $330.00, or $300.00 multiplied by 1.1. Similarly, if the SPA for code K0823 is $300.00, the SPA for code K0816 would be equal to $252.00, or $300.00 multiplied by 0.84. Suppliers submitting bids would be educated in advance that their bid for code K0823 is a bid for all 14 codes and bidding suppliers would factor this into their decision on what amount to submit as their bid for the lead item. This would avoid price inversions and would carry over the relative difference in item weight that establishes Medicare payment amounts for standard power wheelchairs under the fee schedule into the CBPs. The second proposed category for lead item bidding is walkers as shown in Table 27 below. Under our proposal, when bidding for the lead item, a supplier is bidding to furnish the entire grouping (81 FR 42860).
Rather than submitting 9 individual bids for each of the 9 items, the supplier would submit one bid for the lead item. The SPA for lead item E0143 would be based on the median of the bids for this code, following the rules laid out in § 414.416(b) and for calculating rental and purchase amounts per § 414.408(f) and (h)(7). We proposed to include a new § 414.416(b)(3) that would include the lead item bidding method (81 FR 42860, 42878). The SPAs for the other items would be based on the relative difference in fees for the item compared to the lead item, following the rules for inexpensive or routinely purchased items at § 414.408(f) and (h)(7), and, for E0144, following the rules for capped rental items at § 414.408(h)(1). For example, if the SPA for purchase for code E0143 is $80.00, Medicare payment for rental of E0143 would be $8.00 per month in accordance with § 414.408(h)(7), and the SPA for purchase of E0143 used would be $60.00. The SPAs for code E0135 would be equal to $56.80 ($80.00 multiplied by 0.71), for purchase of a new E0135 walker, $5.68 per month for rental of E0135, and $42.60 for purchase of a used E0135 walker. The SPAs for rental of code E0144 would be equal to $21.92 ($8.00 multiplied by 2.74) for rental
The third proposed category for lead item bidding is hospital beds as shown in Table 28. Under the proposal, when bidding for the lead item, a supplier is bidding to furnish the entire grouping (81 FR 42860 through 42861).
Rather than submitting 20 individual bids for each of the 20 items, the supplier would submit one bid for the lead item. The SPA for lead item E0260 would be based on the median of the bids for this code, following the rules laid out in § 414.416(b) and for calculating rental amounts per § 414.408(h)(1). The SPAs for the other items would be based on the relative difference in the average of the 2015 fee schedule amounts for the item compared to the lead item. For example, if the SPA for code E0260 is $75.00, the SPA for code E0261 would be equal to $69.00, or $75.00 multiplied by 0.92. Suppliers submitting bids would be educated in advance that their bid for code E0260 is a bid for all 20 codes and bidding suppliers would factor this into their decision on what amount to submit as their bid for the lead item.
The fourth through seventh proposed categories for lead item bidding are as are shown in Table 29, Table 30, Table 31 and Table 32. Under our proposal, when bidding for the lead item, a supplier is bidding to furnish the entire grouping (81 FR 42861).
In summary, we proposed to revise § 414.412(d) to add this bidding method as an alternative to the current method for submitting bid amounts for each item in the seven groupings of similar items identified above (81 FR 42862). Suppliers participating in future CBPs may be required to use this method when submitting bids for these groups of similar items. Also, we proposed to revise § 414.416(b)(3) to add the method for calculating SPAs for items within each grouping of similar items based on the SPAs for lead items within each grouping of similar items (81 FR 42878). We believe that the proposed method would better accomplish the CBP objectives, which include reducing the amount Medicare pays for DMEPOS and limiting the financial burden on beneficiaries by reducing their out-of-pocket expenses for DMEPOS they obtain through the CBP (72 FR 17996).
We believe this approach to bidding would safeguard beneficiaries from receiving items with fewer features simply because of the price inversions. We also believe that the proposed lead item bidding method would greatly reduce the burden on suppliers of formulating and submitting multiple bids for similar items because it would require less time to enter bids and would reduce the chances of keying errors when submitting bids. Finally, we believe this approach would safeguard beneficiaries and the Medicare Trust Fund from paying higher amounts for items with fewer features.
We solicited comments on this section. We received 4 public comments on our proposals from medical device manufacturers and suppliers.
The comments and our responses to the comments for these proposals are set forth below.
Under the DMEPOS CBP, Medicare sets payment amounts for selected DMEPOS items and services furnished to beneficiaries in CBAs based on bids submitted and accepted by Medicare. Section 1847(b)(5) of the Act provides that Medicare payment for these competitively bid items and services is made on an assignment-related basis and is equal to 80 percent of the applicable SPA, less any unmet Part B deductible described in section 1833(b) of the Act. Section 1847(b)(2)(A)(iii) of the Act prohibits the Secretary from awarding a contract to an entity unless the Secretary finds that the total amounts to be paid to contractors in a CBA are expected to be less than the total amounts that would otherwise be paid. This requirement guarantees savings to both the Medicare program and its beneficiaries. The CBP also includes provisions to ensure beneficiary access to quality DMEPOS items and services: Section 1847 of the Act directs the Secretary to award contracts to entities only after a finding that the entities meet applicable quality and financial standards and beneficiary access to a choice of multiple suppliers in the area is maintained.
We implemented Round 1 of the DMEPOS CBP on January 1, 2011, and the Round 1 Recompete on January 1, 2014. Round 2 of the DMEPOS CBP and the national mail order program were implemented on July 1, 2013, and Round 2 and national mail order Recompete were implemented on July 1, 2016. The programs phased in under Round 1 and 2 are in place in approximately 100 metropolitan statistical areas (MSAs) throughout the nation, including Honolulu, Hawaii. A 60-day bidding window allows bidders adequate time to prepare and submit their bids. Section 414.412 specifies the rules for submission of bids under a CBP. Each bid submission is evaluated
Sections 1847(b)(6)(A)(i) and (b)(6)(A)(ii) of the Act provide that payment will not be made under Medicare Part B for items and services furnished under a CBP unless the supplier has submitted a bid to furnish those items and has been awarded a contract. Therefore, in order for a supplier that furnishes competitively bid items in a CBA to receive payment for those items, the supplier must have submitted a bid to furnish those particular items and must have been awarded a contract to do so.
The April 10, 2007 final rule titled, “Medicare Program; Competitive Acquisition for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) and Other Issues”, finalized requirements for providers to submit bids under the DMEPOS CBP (§ 414.412(b)) (72 FR 17992, 18088). Section 414.412 outlines the requirements associated with submitting bids under the competitive bidding process. Furthermore, § 414.412(b)(2) states that the bids submitted for each item in a product category cannot exceed the payment amount that would otherwise apply to the item under subpart C or subpart D of part 414, which is the fee schedule amount. Therefore, under our current policy, bid amounts that are submitted under the CBP cannot exceed the fee schedule amount. Contracts cannot be awarded in a CBA if total payments under the contracts are expected to be greater than what would otherwise be paid. In the preamble of the CY 2015 final rule that implemented the methodologies to adjust fee schedule amounts using information from CBPs, we indicated that the adjusted fee schedule amounts become the new bid limits (79 FR 66232).
Sections 1834(a)(1)(F)(ii) and (iii), 1834(h)(2)(H)(ii), and 1842(s)(3)(B) of the Act mandate adjustments to the fee schedule amounts for certain DMEPOS items furnished on or after January 1, 2016, in areas that are not CBAs, based on information from CBPs. Section 1842(s)(3)(B) of the Act also provides authority for making adjustments to the fee schedule amounts for enteral nutrients, equipment, and supplies (enteral nutrition) based on information from the CBPs. In the CY 2015 final rule (79 FR 66223), we finalized the methodologies for adjusting DMEPOS fee schedule amounts using information from CBPs at § 414.210(g).
The proposed rule, titled “End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care Model” (81 FR 42802 through 42880), was published in the
Section 1847(b)(2)(A)(iii) of the Act prohibits the awarding of contracts under the program if total payments to contract suppliers in an area are expected to be more than would otherwise be paid. For the purpose of implementing section 1847(b)(2)(A)(iii) of the Act, we proposed to revise § 414.412(b) to use the unadjusted fee schedule amounts (the fee schedule amounts that would otherwise apply if no adjustments to the fee schedule amounts based on information from CBPs had been made) for the purpose of establishing limits on bids for individual items for future competitions (including re-competes) (81 FR 42863). We proposed this change because we believe the general purpose of the DMEPOS CBP is to establish reasonable payment amounts for DMEPOS items and services based on competitions among suppliers for furnishing these items and services, with bids from suppliers being based in part on the suppliers' costs of furnishing the items and services at that point in time. We believe the intent of the program is to replace unreasonably high fee schedule amounts for DMEPOS items and services with lower, more reasonable amounts as a result of the competitive bidding. We believe that as long as the amounts established under CBPs are lower than the fee schedule amounts that would otherwise apply had the DMEPOS CBP not been implemented, savings will continue to be generated by the programs.
For competitions held thus far for contract periods starting on January 1, 2011, July 1, 2013, January 1, 2014, and July 1, 2016, the unadjusted fee schedule amounts were used as the bid limits for all items in all CBAs, and the SPAs for each subsequent competition were generally lower than the SPAs for the preceding competitions. We believe that competition for contracts under the programs will continue to keep bid amounts low and, together with utilizing unadjusted fee schedule amounts as bid limits, ensure that total payments under the program will be less than what would otherwise be paid. We believe that prices established through the competitions should be allowed to fluctuate both up and down over time as long as they do not exceed the previous fee schedule amounts that would otherwise have been paid if the CBP had not been implemented, and savings below the previous fee schedule amounts are achieved. This would not apply to drugs included in a CBP which would otherwise be paid under subpart I of part 414 of 42 CFR based on 95 percent of the average wholesale price in effect on October 1, 2003.
In addition, the amount of the SPAs established under the program is only one factor affecting total payments made to suppliers for furnishing DMEPOS items and services. Although the bid limits were created and are used for implementation of section 1847(b)(2)(A)(iii) of the Act, they are not the only factor that affects total payments to suppliers. The DMEPOS CBP is effective in reducing fraud and abuse by limiting the number of entities that can submit claims for payment, while ensuring beneficiary access to necessary items and services in CBAs. Section 1847(b)(5) of the Act requires that payment to contract suppliers be made on an assignment-related basis and limits beneficiary cost sharing to 20 percent of the SPA. We will continue to take all of these factors into account before awarding contracts for subsequent competitions in order to
In summary, we proposed to revise § 414.412(b) to specify that the bids submitted for each individual item of DMEPOS other than drugs cannot exceed the fee schedule amounts established in accordance with sections 1834(a), 1834(h), or 1842(s) of the Act for DME, off-the-shelf (OTS) orthotics, and enteral nutrition, respectively, as if adjustments to these amounts based on information from CBPs had not been made (81 FR 42863). Specifically, the bid limits for DME would be based on the 2015 fee schedule amounts established in accordance with section 1834(a)(1)(B)(ii) of the Act, prior to application of section 1834(a)(1)(F)(ii) and (iii) of the Act, but updated for subsequent years based on the factors provided at section 1834(a)(14) of the Act. In other words, the bid limits would be based on fee schedule amounts established in accordance with section 1834(a), without applying the adjustments mandated by section 1834(a)(1)(F)(ii) of the Act. The bid limits for OTS orthotics would also be based on the 2015 fee schedule amounts established in accordance with section 1834(h)(1)(B)(ii) of the Act, prior to application of section 1834(h)(1)(H), but updated for subsequent years based on the factors provided at section 1834(h)(4) of the Act. In other words, the bid limits would be based on fee schedule amounts established in accordance with section 1834(h), without applying the adjustments authorized by section 1834(h)(1)(H) of the Act. The bid limits for enteral nutrients, equipment, and supplies (enteral nutrition) would be based on the 2015 fee schedule amounts established in accordance with section 1842(s)(1) of the Act, prior to application of section 1842(s)(3), but updated for subsequent years based on the factors provided at section 1842(s)(1)(B)(ii) of the Act. In other words, the bid limits would be based on fee schedule amounts established in accordance with section 1842(s)(1), without applying the adjustments authorized by section 1842(s)(3)(B) of the Act (81 FR 42863).
Finally, with respect to the alternative bidding rules proposed in section VII. above, when evaluating bids for a grouping of similar items in a product category submitted in the form of a single bid for the highest volume item in the grouping, or lead item, we proposed to use the weighted average fee schedule amounts for the grouping of similar items in order to establish the bid limit for the purpose of implementing this proposed provision (81 FR 42863). We proposed to revise § 414.412(b)(2) to use total nationwide allowed services for all areas for the individual items, initially from calendar year 2012, to weight the fee schedule amount for each item for the purpose of determining a bid limit for the lead item based on the weighted average fee schedule amounts for the entire grouping of similar items. This would ensure that the payment amounts established under the CBPs do not exceed the fee schedule amounts that would otherwise apply to the grouping of similar items as a whole. As discussed in the proposed rule, Table 33 below illustrates the data that would be used to calculate the bid limit for the lead item (code E0143) in the grouping of walkers for a CBA located in the state of Maryland using 2015 fee schedule amounts for illustration purposes. The item weight for each code is based on 2012 total nationwide allowed services for the code divided by total nationwide allowed services for 2012 for all of the codes in the grouping (81 FR 42864).
Summing the 2015 fee schedule amounts multiplied by the weights for each item results in a bid limit of $117.37 for lead item E0143. Bids submitted for the lead item E0143 for walkers for a CBA located in the state of Maryland would not be able to exceed $117.37 in this example. We therefore proposed to amend § 414.412(b) to establish this method for determining bid limits for lead items identified in accordance with section § 414.412(d)(2) in section VII. B and as referenced also in the proposed rule (81 FR 42864, 42877), which we are now finalizing.
We solicited comments and we received approximately 13 public comments on our proposals, including comments from medical device manufacturers, suppliers, advocacy groups and coalitions, and the Medicare Payment Advisory Committee (MedPAC).
The comments and our responses to the comments for these proposals are set forth below.
The Medicare and Medicaid programs generally serve distinct populations, but more than ten million individuals (“dual eligible beneficiaries”) were enrolled in both programs in 2014.
Both Medicare and Medicaid cover Durable Medical Equipment (DME), which can be essential to dual eligible beneficiaries' mobility, respiratory function, and activities of daily living. However, the programs' different eligibility, coverage, and supplier rules can impact access to medically-appropriate DME and repairs of existing equipment for the population enrolled in both benefits.
The proposed rule, titled “End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care Model” (81 FR 42802 through 42880), was published in the
In this final rule, we provide a summary of the public comments received and our response to them.
CMS sought to examine how overlapping but differing coverage standards for DME under Medicare and Medicaid may affect access to care for beneficiaries and administrative processes for providers and suppliers. In response to a May 2011 Request for Information, CMS received over one hundred comments from a range of stakeholders regarding 29 areas of program alignment opportunities, including DME.
According to stakeholders, a common barrier to DME access stems from conflicting approval processes among Medicare and Medicaid that can leave suppliers uncertain about whether and how either program will cover items. Medicare is the primary payer for DME and other medical benefits covered by both programs. Medicaid typically pays Medicare cost-sharing amounts and may cover DME that Medicare does not, including certain specialized equipment that promotes independent living. Medicaid pays secondary to most other legally liable payers, including Medicare, and requires those payers to pay to the limit of their legal liability before any Medicaid payment is available. Many of the Medicare requirements related to DME, including the definition and scope of the benefit, are mandated by the statute; therefore, we do not have the authority to bypass or alter these requirements. Medicare generally only processes claims after the equipment is delivered. Because suppliers lack assurance regarding how Medicare or Medicaid will cover DME at the point of sale—and dual eligible beneficiaries cannot pay out-of-pocket up front—suppliers may refuse to provide needed DME.
Other barriers may emerge for beneficiaries who have Medicaid first and get DME prior to enrolling in Medicare. Stakeholders report that many individuals may have difficulty getting coverage for repairs on equipment obtained through Medicaid coverage, since Medicare will only pay for repairs after making a new medical necessity determination. Additionally, not all Medicaid-approved DME suppliers are Medicare-approved suppliers, meaning beneficiaries may need to change suppliers after enrolling in Medicare.
CMS requested to receive additional information to help target efforts to promote timely access to DME benefits for people dually eligible for Medicare and Medicaid.
We requested public input on the following issues related to DME access for dual eligible beneficiaries:
• Obstacles to timely receipt of needed DME and repairs due to conflicting program requirements.
• Challenges or opportunities faced by Medicaid beneficiaries who newly qualify for Medicare, including challenges related to new and preexisting items, repairs, and providers.
• The percentage of Medicare competitive bidding contractors in the state which accept Medicaid.
• The role of prior authorization policies under either program and
• Impacts on beneficiaries from delayed access to needed equipment and repairs.
• If access problems are more pronounced for certain categories of equipment, the categories of DME for which the access problems arise the most frequently or are most difficult to resolve.
• Challenges faced by suppliers in meeting different supporting documentation and submission requirements.
• Other prevalent access challenges due to DME program misalignments.
We also invited feedback regarding potential regulatory or legislative reforms to address DME program misalignments including:
• State Medicaid program policies that promote coordination of benefits and afford beneficiaries full access to benefits.
• Strategies to promote access to timely, effective repairs, including from suppliers who that did not originally furnish the equipment.
• Policies to address challenges faced when beneficiaries transition from Medicaid-only to dual eligible status.
• Other ways to promote timely DME access for dual eligible beneficiaries, without introducing new program integrity risks or increasing total expenditures in either Medicare or Medicaid.
We requested specific examples to be included, when possible, while avoiding the transmission of protected information, and to include a point of contact who can provide additional information upon request.
The comments and our response to the comments for issues related to DME access for dual eligible beneficiaries are set forth below.
In addition to elaborating on the challenges faced, a number of commenters suggested potential changes to the administration of Medicare and Medicaid DME benefits. With respect to Medicare, some commenters suggested that CMS require that DME suppliers accept Medicaid as a condition of being selected in Medicare's competitive bidding program. One commenter suggested expansions to the Advance Determination of Medicare Coverage (ADMC) policy related to certain replacement parts. Many commenters support certain Medicare payment changes to promote easier access to needed repairs. Some commenters suggested establishing a Medicare transition policy for DME similar to the Part D transition policy that would cover suppliers and certain DME.
Commenters also suggested changes to Medicaid administrative processes. Many commenters suggested a Medicaid prior authorization process that assures suppliers of Medicaid coverage if Medicare were to deny coverage. A few commenters suggested clarifying that Medicare denial should not be required for items Medicare never covers. Finally, some commenters suggested that any such changes apply as well to Medicaid managed care organizations that enroll dual eligible beneficiaries and are contracted to provide Medicaid DME coverage.
The Comprehensive ESRD Care (CEC) Model is a CMS test of a dialysis-specific Accountable Care Organization (ACO) model. In the model, dialysis clinics, nephrologists and other providers join together to create an End-Stage Renal Disease (ESRD) Seamless Care Organization (ESCO) to coordinate care for aligned beneficiaries. ESCOs are accountable for clinical quality outcomes and financial outcomes measured by Medicare Part A and B spending, including all spending on dialysis services for their aligned ESRD beneficiaries. This model encourages dialysis providers to think beyond their traditional roles in care delivery and supports them as they provide patient-centered care that will address beneficiaries' health needs, both in and outside of the dialysis clinic.
CMS sought input on innovative approaches to care delivery and financing for beneficiaries with ESRD. We explained that this input could include ideas related to innovations that would go above and beyond the Comprehensive ESRD Care CEC Model with regard to financial incentives, populations or providers engaged, or the scale of change, among other topics. We stated that we would consider information received as we developed future payment models in this area, and as we launched solicitation for a second round of entry into the CEC Model to begin on January 1, 2017.
The proposed rule, titled “End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care Model” (81 FR 42802 through 42880), was published in the
We also noted a solicitation for new entrants to the CEC model, which has since closed. New ESCOs will be announced on or before January 1, 2017, when they begin participation in the model.
Section 1115A of the Social Security Act (the Act), as added by section 3021 of the Affordable Care Act, authorizes the Innovation Center to test innovative payment and service delivery models that reduce spending under Medicare, Medicaid or The Children's Health Insurance Program (CHIP), while preserving or enhancing the quality of care. We sought public input to gather responses to the following questions that will help us to develop and refine innovative payment models related to kidney care.
Questions:
1. How could participants in alternative payment models (APMs) and advanced APMs coordinate care for beneficiaries with chronic kidney disease and to improve their transition into dialysis?
2. How could participants in APMs and advanced APMs target key interventions for beneficiaries at different stages of chronic kidney disease?
3. How could participants in APMs and advanced APMs better promote increased rates of renal transplantation?
4. How could CMS build on the CEC Model or develop alternative approaches for improving the quality of care and reducing costs for ESRD beneficiaries?
5. Are there specific innovations that are most appropriate for smaller dialysis organizations?
6. How could primary-care based models better integrate with APMs or advanced APMs focused on kidney care to help prevent development of chronic kidney disease in patients and progression to ESRD? Primary-care based models may include patient-centered medical homes or other APMs.
7. How could APMs and advanced APMs help reduce disparities in rates of chronic kidney disease (CKD)/ESRD and adverse outcomes among racial/ethnic minorities?
8. Are there innovative ways APMs and advanced APMs can facilitate changes in care delivery to improve the quality of life for CKD and ESRD patients?
9. Are there specific innovations that are most appropriate for evaluating patients for suitability for home dialysis and promoting its use in appropriate populations?
10. Are there specific innovations that could most effectively be tested in a potential mandatory model?
Additional information on the Comprehensive ESRD Care Model is located at:
The comments and our responses to the comments are set forth below.
In the CY 2013 ESRD PPS final rule (77 FR 67520), we revised § 413.89(h)(3) to set forth the percentage reduction in allowable bad debt payment required by section 1861(v)(1)(W) of the Act for ESRD facilities for cost reporting periods beginning during fiscal year 2013, fiscal year 2014 and subsequent fiscal years. We also revised § 413.89(h)(3) to set forth the applicability of the cap on bad debt reimbursement to ESRD facilities for cost reporting periods beginning between October 1, 2012 and December 31, 2012. In addition, in that rule, we removed and reserved § 413.178, since there were revised provisions set out at § 413.89.
As a part of these revisions, we intended to correct the cross-reference in §§ 413.194 and 413.215 so that § 413.89(h)(3) was referenced instead of § 413.178. We inadvertently omitted the regulations text that would have made those changes. Therefore, we proposed a technical correction to revise the regulations text at §§ 413.194 and 413.215 to correct the cross-reference to the Medicare bad debt reimbursement regulation, so that §§ 413.194 and 413.215 would reference 42 CFR 413.89(h)(3) instead of the current outdated reference to § 413.178.
We did not receive any comments on our proposed technical correction to revise the regulations text at §§ 413.194 and 413.215, therefore, we are finalizing this revision as proposed.
We ordinarily publish a notice of proposed rulemaking in the
We find it unnecessary to undertake notice and comment rulemaking in this instance for the additional changes we are making to the definition of “hearing officer” in § 414.402, because these are merely technical edits in order to conform the definition to the revised regulation we are finalizing at § 414.423, which was promulgated under the notice and comment rulemaking procedures. Removing the reference to “contract terminations” and the abbreviation “(HO)” under the existing definition of “hearing officer” will reconcile the definition with the terminology and appeals process we are adopting in this final rule and thus, makes additional notice and comment unnecessary. Therefore, under section 553(b)(B) and section 1871(b)(1) of the Act, for good cause, we waive notice and comment procedures.
HHS has a number of initiatives designed to improve health and health care quality through the adoption of health information technology (health
The Office of the National Coordinator for Health Information Technology (ONC) has released a document entitled “Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap Version 1.0 (Roadmap) (available at
In addition, ONC has released the 2016 Interoperability Standards Advisory (available at
We encourage stakeholders to utilize health information exchange and certified health IT to effectively and efficiently help providers improve internal care delivery practices, support management of care across the continuum, enable the reporting of electronically specified clinical quality measures, and improve efficiencies and reduce unnecessary costs. As adoption of certified health IT increases and interoperability standards continue to mature, HHS will seek to reinforce standards through relevant policies and programs.
Under the Paperwork Reduction Act of 1995, we are required to provide 30-day notice in the
• The need for the information collection and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our estimate of the information collection burden.
• The quality, utility, and clarity of the information to be collected.
• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
In section II and III of this final rule, we include changes to the regulatory text for the ESRD PPS in CY 2017 as well as the inclusion of subpart K to part 494 for AKI. However, we note that those changes do not impose any new information collection requirements.
In section V of this final rule, we discussed changes to the DMEPOS Competitive Bidding Program. Section V.B.1 discusses the changes to the program relative to the bid surety bond requirements imposed at § 414.412. As a result of the new bid surety bond requirements, we have revised the information collection request (ICR) associated with the DMEPOS Competitive Bidding Program. The ICR is currently approved under OMB control number 0938-1016 (CMS-10169). Specifically, we have revised Form A (Application for DMEPOS Competitive Bidding Program) in the ICR to account for the new bid surety bond requirements. The revised form was under development and not available for public review and comment when the DMEPOS Competitive Bidding Program proposed rule published. Therefore, we have published a separate 60-day
This final rule does not impose any new information collection requirements in the regulation text, as specified above. However, this final rule does make reference to several associated information collections that are not discussed in the regulation text contained in this document. The following is a discussion of these information collections.
In the CY 2016 ESRD PPS Final Rule (80 FR 69069), we stated that it was reasonable to assume that Medical Records and Health Information Technicians, who are responsible for organizing and managing health
In the CY 2016 ESRD PPS Final Rule (80 FR 69070), we estimated that the time required to submit measure data using CROWNWeb is 2.5 minutes per data element submitted, which takes into account the small percentage of data that is manually reported, as well as the human interventions required to modify batch submission files such that they meet CROWNWeb's internal data validation requirements.
In our proposed rule (81 FR 42867), we outlined our data validation proposal for PY 2019. Specifically, for the CROWNWeb validation, we proposed to randomly sample records from 300 facilities as part of our continuing pilot data-validation program. Each sampled facility would be required to produce approximately 10 records, and the sampled facilities will be reimbursed by our validation contractor for the costs associated with copying and mailing the requested records. The burden associated with these validation requirements is the time and effort necessary to submit the requested records to a CMS contractor. We estimate that it will take each facility approximately 2.5 hours to comply with this requirement. If 300 facilities are asked to submit records, we estimate that the total combined annual burden for these facilities will be 750 hours (300 facilities × 2.5 hours). Since we anticipate that Medical Records and Health Information Technicians or similar administrative staff would submit this data, we estimate that the aggregate cost of the CROWNWeb data validation would be approximately $19,088 (750 hours × $25.45/hour) total of approximately $64 ($19,088/300 facilities) per facility in the sample. The burden associated with these requirements is captured in an information collection request (OMB control number 0938-1289).
Under the proposed data validation study for validating data reported to the NHSN Dialysis Event Module, we proposed to randomly select 35 facilities. A CMS contractor will send these facilities requests for medical records for all patients with “candidate events” during the evaluation period. Overall, we estimate that, on average, quarterly lists will include two positive blood cultures per facility, but we recognize these estimates may vary considerably from facility to facility. We estimate that it will take each facility approximately 60 minutes to comply with this requirement (30 minutes from each of the two quarters in the evaluation period). If 35 facilities are asked to submit records, we estimate that the total combined annual burden for these facilities will be 35 hours (35 facilities × 1 hour). Since we anticipate that Medical Records and Health Information Technicians or similar administrative staff would submit this data, we estimate that the aggregate cost of the NHSN data validation would be $890.75 (35 hours × $25.45/hour) total of $25.45 ($890.75/35 facilities) per facility in the sample. The burden associated with these requirements is captured in an information collection request (OMB control number 0938-NEW).
We proposed to include, beginning with the PY 2020 ESRD QIP, a reporting measure requiring facilities to report in CROWNWeb an ultrafiltration rate at least once per month for each qualifying patient. We estimate the burden associated with this measure to be the time and effort necessary for facilities to collect and submit the information required for the Ultrafiltration Rate Reporting Measure. We estimated that approximately 6,454 facilities will treat 548,430 ESRD patients nationwide in PY 2020. The Ultrafiltration Rate Reporting Measure requires facilities to report 13 elements per patient per month (156 elements per patient per year) and we estimate it will take facilities approximately 0.042 hours (2.5 minutes) to submit data for each data element. Therefore, the estimated total annual burden associated with reporting this measure in PY 2020 is approximately 3,593,313 hours (548,430 ESRD patients nationwide × 156 data elements/year × 0.042 hours per element), or approximately 553 hours per facility. We anticipate that Medical Records and Health Information Technicians or similar administrative staff will be responsible for this reporting. We therefore believe the cost for all ESRD facilities to comply with the reporting requirements associated with the ultrafiltration rate reporting measure would be approximately $91,449,815.80 (3,593,313 × $25.45/hour), or $14,082.20 per facility. The burden associated with these requirements is captured in an information collection request (OMB control number 0938-NEW).
We sought comments on the Collection of Information proposals and did not receive any comments. Therefore, we are finalizing as proposed.
We have examined the impacts 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 (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2).
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule: (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as economically significant); (2) creating a serious inconsistency or
A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This rule is not economically significant within the meaning of section 3(f)(1) of the Executive Order, since it does not meet the $100 million threshold. However, OMB has determined that the actions are significant within the meaning of section 3(f)(4) of the Executive Order. Therefore, OMB has reviewed these final regulations, and the Departments have provided the following assessment of their impact.
We sought comments on the Regulatory Impact Analysis but did not receive any comments. Therefore we are not making any changes at this time and are finalizing as proposed.
This rule finalizes a number of annual updates and several policy changes to the ESRD PPS in CY 2017. The annual updates include the CY 2017 wage index values, the wage index budget-neutrality adjustment factor, and outlier payment threshold amounts. In addition to these annual updates, we are changing the home dialysis training policy. Failure to publish this final rule by November 1, 2016, would result in ESRD facilities not receiving appropriate payments in CY 2017 for renal dialysis services furnished to ESRD patients in accordance with section 1861(s)(2)(F) of the Act.
This rule finalizes the provisions in TPEA which provide for coverage and payment for renal dialysis services furnished by ESRD facilities to individuals with AKI. Failure to publish this final rule by November 1, 2016 would result in a failure to comply with the requirements of the Act, as added by the TPEA, including ESRD facilities not receiving payment for furnishing renal dialysis services to patients with AKI.
This rule finalizes requirements for the ESRD QIP, including adopting a measure set for the PY 2020 program, as directed by section 1881(h) of the Act. Failure to finalize requirements for the PY 2020 ESRD QIP would prevent continuation of the ESRD QIP beyond PY 2019. In addition, finalizing requirements for the PY 2020 ESRD QIP provides facilities with more time to review and fully understand new measures before their implementation in the ESRD QIP.
This rule finalizes a requirement for the DMEPOS CBP for bid surety bonds and state licensure in accordance with section 1847 of the Act, as amended by section 522(a) of MACRA. The rule also finalizes an appeals process for all breach of contract actions CMS may take.
This rule also finalizes a method for adjusting DMEPOS fee schedule amounts for similar items with different features using information from the DMEPOS CBPs, a method for determining single payment amounts for similar items with different features under the DMEPOS CBPs, and revising bid limits for individual items under DMEPOS CBP.
We estimate that the finalized revisions to the ESRD PPS will result in an increase of approximately $80 million in payments to ESRD facilities in CY 2017, which includes the amount associated with updates to the outlier thresholds, home dialysis training policy, and updates to the wage index. We estimate approximately $2.0 million that would now be paid to ESRD facilities for dialysis treatments provided to AKI beneficiaries.
For PY 2019, we anticipate that the new burdens associated with the collection of information requirements will be approximately $21 thousand, totaling an overall impact of approximately $15.5 million as a result of the PY 2019 ESRD QIP.
As explained previously in this final rule, we anticipate that DMEPOS CBP bidding entities will be impacted by the bid surety bond requirement. Bidding entities will be required to purchase and provide proof of a bid surety bond for each CBA in which they bid. We estimate that the total cost for all bidding suppliers in Round 2019 will be $13,000,000. The state licensure requirement will have no new impact on the supplier community because this is already a basic supplier eligibility requirement at § 414.414(b)(3), and the appeals process for breach of contract actions may have a beneficial, positive impact on suppliers.
Overall, the bid surety bond requirement may have a positive financial impact on the CBP as we anticipate that the requirement will provide an additional incentive for bidding entities to submit substantiated bids. However, there will be an administrative burden for implementation of the bid surety bond requirement for CMS. We expect minimal administrative costs associated with the state licensure and appeals process for breach of DMEPOS CBP contract proposed rules.
We do not anticipate that the DMEPOS Competitive Bidding regulations we are finalizing will have an impact on Medicare beneficiaries.
We estimate that our final methodology for adjusting DMEPOS fee schedule amounts for similar items with different features using information from the DMEPOS CBPs, changes for determining single payment amounts for similar items with different features under the DMEPOS CBPs, and revisions to the bid limits for items under the DMEPOS CBP will have no significant impact on the suppliers, beneficiaries, Part B trust fund and economy as a whole.
To understand the impact of the changes affecting payments to different categories of ESRD facilities, it is necessary to compare estimated payments in CY 2016 to estimated payments in CY 2017. To estimate the impact among various types of ESRD facilities, it is imperative that the estimates of payments in CY 2016 and CY 2017 contain similar inputs. Therefore, we simulated payments only for those ESRD facilities for which we are able to calculate both current payments and new payments.
For this final rule, we used the June 2016 update of CY 2015 National Claims History file as a basis for Medicare dialysis treatments and payments under the ESRD PPS. We updated the 2015 claims to 2016 and 2017 using various updates. The updates to the ESRD PPS base rate are described in section II.B.3 of this final rule. Table 34 shows the impact of the estimated CY 2017 ESRD
Column A of the impact table indicates the number of ESRD facilities for each impact category and column B indicates the number of dialysis treatments (in millions). The overall effect of the final changes to the outlier payment policy described in section II.B.3.c of this final rule is shown in column C. For CY 2017, the impact on all ESRD facilities as a result of the changes to the outlier payment policy would be a 0.73 percent increase in estimated payments. Nearly all ESRD facilities are anticipated to experience a positive effect in their estimated CY 2017 payments as a result of the outlier policy changes.
Column D shows the effect of the final CY 2017 wage indices. The categories of types of facilities in the impact table show changes in estimated payments ranging from a 0.0 percent decrease to a 0.1 percent increase due to these updates.
Column E shows the effect of the final ESRD PPS payment rate update of 0.55 percent. This update reflects the final ESRDB market basket percentage increase factor for CY 2017 of 2.1 percent, the 1.25 percent reduction as required by the section 1881(b)(14)(F)(i)(I) of the Act, and the MFP adjustment of 0.3 percent.
Column F reflects the overall impact, that is, the effects of the outlier policy changes, the wage index, the effect of the change in the home dialysis training add-on from $50.16 to $95.60 and the effect of the payment rate update. We expect that overall ESRD facilities will experience a 0.73 percent increase in estimated payments in 2017. The categories of types of facilities in the impact table show impacts ranging from an increase of 0.7 percent to an increase
Under the ESRD PPS, Medicare pays ESRD facilities a single bundled payment for renal dialysis services, which may have been separately paid to other providers (for example, laboratories, durable medical equipment suppliers, and pharmacies) by Medicare prior to the implementation of the ESRD PPS. Therefore, in CY 2017, we estimate that the ESRD PPS would have zero impact on these other providers.
We estimate that Medicare spending (total Medicare program payments) for ESRD facilities in CY 2017 would be approximately $9.6 billion. This estimate takes into account a projected increase in fee-for-service Medicare dialysis beneficiary enrollment of 1.4 percent in CY 2017.
Under the ESRD PPS, beneficiaries are responsible for paying 20 percent of the ESRD PPS payment amount. As a result of the projected 0.73 percent overall increase in the ESRD PPS payment amounts in CY 2017, we estimate that there will be an increase in beneficiary co-insurance payments of 4.2 percent in CY 2017, which translates to approximately $10 million.
In section II.B.2, we finalized a change to the home dialysis training add-on based on the average number of hours for PD and HD and weighted by the percentage of total treatments for each modality. We considered an approach to update the current training add-on amount annually using the market basket increase or the wage and price proxy in the market basket. However, under either approach, the increase to the training add-on payment was small and would not incentivize home dialysis training.
We analyzed CY 2015 hospital outpatient claims to identify the number of treatments furnished historically for AKI patients. We identified 8,047 outpatient dialysis treatments for beneficiaries with AKI that were furnished in CY 2015. We then inflated the 8,047 treatments to 2017 values using estimated population growth for fee-for service non-ESRD beneficiaries. This results in an estimated 8,234 treatments that would now be paid to ESRD facilities for furnishing dialysis to beneficiaries with AKI. Using the CY 2017 ESRD base rate of $231.55 and an average wage index multiplier, we estimate approximately $2.0 million that would now be paid to ESRD facilities for dialysis treatments provided to AKI beneficiaries.
Ordinarily, we would provide a table showing the impact of this provision on various categories of ESRD facilities. Because we have no way to project how many patients with AKI requiring dialysis will choose to have dialysis treatments at an ESRD facility, we are unable to provide a table at this time.
We note that in the CY 2017 ESRD PPS proposed rule (81 FR 42870), we stated that we identified 7,155 outpatient claims with AKI that also had dialysis treatments that were furnished in CY 2015. This is an incorrect statement. We should have stated that we identified 7,155 outpatient dialysis treatments for beneficiaries with AKI.
Under section 1834(r) of the Act, as added by section 808(b) of TPEA, we are finalizing a payment rate for renal dialysis services furnished by ESRD facilities to beneficiaries with AKI. The only two Medicare providers authorized to provide these outpatient renal dialysis services are hospital outpatient departments and ESRD facilities. The decision about where the renal dialysis services are furnished is made by the patient and their physician. Therefore, this proposal will have zero impact on other Medicare providers.
We anticipate an estimated $2.0 million being redirected from hospital outpatient departments to ESRD facilities in CY 2017 as a result of some AKI patients receiving renal dialysis services in the ESRD facility at the lower ESRD PPS base rate versus continuing to receive those services in the hospital outpatient setting.
Currently, beneficiaries have a 20 percent co-insurance obligation when they receive AKI dialysis in the hospital outpatient setting. When these services are furnished in an ESRD facility, the patients would continue to be responsible for a 20 percent co-insurance. Because the AKI dialysis payment rate paid to ESRD facilities is lower than the Outpatient Prospective Payment System's payment amount, we would expect beneficiaries to pay less co-insurance when AKI dialysis is furnished by ESRD facilities.
In section III.B.2 of this final rule, we finalize policy related to the implementation of section 808(b) of TPEA, which amended section 1834 by adding a new paragraph (r) which provides payment for renal dialysis services furnished by ESRD facilities to beneficiaries with AKI. We considered adjusting the AKI payment rate by including the ESRD PPS case-mix adjustments, other adjustments at 1881(b)(14)(D), as well as not paying separately for AKI specific drugs and labs. We ultimately determined that treatment for AKI is substantially different from treatment for ESRD and the case-mix adjustments applied to ESRD patients may not be applicable to AKI patients and as such, including those policies and adjustment would be inappropriate at this time.
The ESRD QIP provisions are intended to prevent possible reductions in the quality of ESRD dialysis facility services provided to beneficiaries as a result of payment changes under the ESRD PPS.
The methodology that we proposed using to determine a facility's TPS for the PY 2020 ESRD QIP is described in sections III.F.6 and III.F.7 of this final rule. Any reductions in ESRD PPS payments as a result of a facility's performance under the PY 2020 ESRD QIP would apply to ESRD PPS payments made to the facility in CY 2020.
We estimate that, of the total number of dialysis facilities (including those not receiving a TPS), approximately 42 percent or 2,710 of the facilities would likely receive a payment reduction in PY 2020. Facilities that do not receive a TPS are not eligible for a payment reduction.
In conducting our impact assessment, we have assumed that there will be 6,453 dialysis facilities paid through the PPS. Table 35 shows the overall estimated distribution of payment reductions resulting from the PY 2020 ESRD QIP.
To estimate whether or not a facility would receive a payment reduction in PY 2020, we scored each facility on achievement and improvement on several measures we have previously finalized and for which there were available data from CROWNWeb and Medicare claims. Measures used for the simulation are shown in Table 36.
Clinical measure topic areas with less than 11 cases for a facility were not included in that facility's Total Performance Score. Each facility's Total Performance Score was compared to an estimated minimum Total Performance Score and an estimated payment reduction table that were consistent with the proposals outlined in section III.G.9 of this final rule. Facility reporting measure scores were estimated using available data from CY 2015. Facilities were required to have a score on at least one clinical and one reporting measure in order to receive a Total Performance Score.
To estimate the total payment reductions in PY 2020 for each facility resulting from the proposed rule, we multiplied the total Medicare payments to the facility during the 1-year period between January 2015 and December 2015 by the facility's estimated payment reduction percentage expected under the ESRD QIP, yielding a total payment reduction amount for each facility: (Total ESRD payment in January 2015 through December 2015 times the estimated payment reduction percentage). For PY 2020, the total payment reduction for all of the 2,710 facilities expected to receive a reduction is approximately $32 million ($31,581,441). Further, we estimate that the total costs associated with the collection of information requirements for PY 2020 described in section VIII.1.b of this final rule would be approximately $91 million for all ESRD facilities. As a result, we estimate that ESRD facilities will experience an aggregate impact of approximately $123 million ($91,449,815 + $31,581,441= $123,031,256) in PY 2020, as a result of the PY 2020 ESRD QIP.
Table 37 below shows the estimated impact of the finalized ESRD QIP payment reductions to all ESRD facilities for PY 2020. The table details the distribution of ESRD facilities by facility size (both among facilities considered to be small entities and by number of treatments per facility), geography (both urban/rural and by region), and by facility type (hospital based/freestanding facilities). Given that the time periods used for these calculations will differ from those we proposed to use for the PY 2020 ESRD QIP, the actual impact of the PY 2020 ESRD QIP may vary significantly from the values provided here.
Lastly, we note that the facilities located in the US Territories and earning a payment penalty are primarily urban, Large Dialysis Organizations and we wish to confirm that we will work through the ESRD Networks to address issues of quality of care at these locations.
For instance, an authorized surety may establish a preliminary charge amount of 2 percent of the total bond amount to obtain a $50,000 bid surety bond. We anticipate that the authorized surety may adjust their charge percentage based on the number of CBAs in which a bidding entity bids, that is, a bulk discount. Bidding entities that purchase multiple bid surety bonds from the authorized surety would likely receive a reduced charge per bid surety bond as compared to a bidding entity that only purchases a single bid surety bond. We also expect that authorized sureties will evaluate each bidding entity's credit score(s) to either establish an appropriate charge percentage or to decide not to issue a bond if the bidding entity's credit score is too low. Lastly, we anticipate that an authorized surety may also request documentation from prior rounds of bidding to understand the bidding entity's experience with contract acceptance. Bidding entities that have accepted more contract offers in the prior round without any contract rejections may be viewed by an authorized surety as less risky than a bidding entity who has rejected numerous contract offers with few or no contract acceptance.
On January 1, 2019, CMS will be combining all CBAs into a consolidated round of competition. As a result, we estimate the aggregate total out of pocket cost for bidding entities to bid in this competition to be $13,000,000. This estimate is based upon the approximately 13,000 distinct bidders for CBAs included in both the Round 2 Recompete and Round 1 2017 multiplied by a $1,000 per bid surety bond price. Given the unknown variables with this new type of bond, we sought comments on how the
We do anticipate that there will be an impact on small suppliers. We sought comments on whether we should have a reduced bid surety bond amount for a particular subset of suppliers, for example, small suppliers as defined by the CBP. In terms of a small supplier obtaining a bond, the Small Business Administration (SBA) has a statement on their Web site stating that their guarantee “encourages surety companies to bond small businesses,” and as such we anticipate that small suppliers will be able to reach out to the SBA if they encounter difficulty in obtaining a bond. As a result of the implementation of the final rule, we anticipate that this requirement may deter some suppliers from bidding, which would result in a lower number of bids submitted to the DMEPOS CBP.
We anticipate that this regulation may deter some bidding entities from bidding, which would result in a lower number of bids submitted to the DMEPOS CBP. This reduction could reduce competition and lead to a decreased number of contract suppliers and, as a result, less savings from the program.
Additionally, we expect that there will be an administrative burden for implementing the bid surety bond requirement, which includes educating bidding entities, updating CMS bidding and contracting systems, and verifying that the bonds are valid.
The final CBP requirements for bid surety bond, state licensure and appeals process for breach of contract actions are not expected to have an impact on Medicare beneficiaries.
Section 1847(a)(1)(G) of the Act, as amended by section 522(a) of MACRA, provides that a bidding entity may not submit a bid for a CBA unless, as of the deadline for bid submission, the entity has (1) obtained a bid surety bond, and (2) provided proof of having obtained the bid surety bond for each CBA associated with its bid(s) in a form specified by the Secretary. No alternatives to this bid surety bond requirement were considered. However, while we proposed that the bid surety bond be in an amount of $100,000, we sought comments on whether a lower bond amount for a certain subset of bidding entities, for example, small suppliers as defined by 42 CFR 414.402, would be appropriate. In finalizing the rule we determined that the bid surety bond will be set at $50,000 for all bidding entities based on comments received. No alternatives were considered for the state licensure requirement, as § 414.414(b)(3) of the regulations already requires suppliers to have all applicable state and local licenses.
For appeals for breach of contract actions, we believe that it would be beneficial to expand the appeals process to any of the breach of contract actions that CMS may take pursuant to § 414.422(g)(2). The alternative we considered is to retain the current appeals process for terminations, and allow suppliers to appeal other breach of contract actions through an informal sub-regulatory process or a process similar to the existing appeals process. However, in order to provide an opportunity for notice and comment, we believe that the better option is to revise the current regulations to allow for a clear and defined appeals process for any breach of contract action that CMS may take.
For this final rule, we estimate that the method for adjusting DMEPOS fee schedule amounts for certain groupings of similar items with different features using information from the DMEPOS CBPs will generate small savings by lowering the price of similar items to be equal to the weighted average of the SPAs for the items based on the item weights assigned under competitive bidding. The reduced price causes lower copayments to the beneficiary. We believe our final policy will also prevent beneficiaries from potentially receiving lower cost items at higher coinsurance rates. Suppliers will be impacted little by the methodological change because the final methodology we are adopting has a small saving attached to it.
In this final rule, we estimate that the method for determining single payment amounts for certain groupings of similar items with different features under the
In this final rule, we estimate the bid limits for items under the DMEPOS CBP will not have a significant fiscal impact on the Medicare program because we anticipate little change in Medicare payment due to the revised bid limits. This revision will provide clearer limits. We estimate our revision to the bid limits at the unadjusted fee level would have little fiscal impact in that competitions will continue to reduce prices. This final rule will benefit suppliers and beneficiaries because payments will be allowed to fluctuate somewhat to account for increases in the costs of furnishing items, including newer technology items.
As required by OMB Circular A-4 (available at
The Regulatory Flexibility Act (September 19, 1980, Pub. L. 96-354) (RFA) requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Approximately 14 percent of ESRD dialysis facilities are considered small
We do not believe ESRD facilities are operated by small government entities such as counties or towns with populations of 50,000 or less, and therefore, they are not enumerated or included in this estimated RFA analysis. Individuals and States are not included in the definition of a small entity.
For purposes of the RFA, we estimate that approximately 14 percent of ESRD facilities are small entities as that term is used in the RFA (which includes small businesses, nonprofit organizations, and small governmental jurisdictions). This amount is based on the number of ESRD facilities shown in the ownership category in Table 34. Using the definitions in this ownership category, we consider the 578 facilities that are independent and the 358 facilities that are shown as hospital-based to be small entities. The ESRD facilities that are owned and operated by LDOs and regional chains would have total revenues of more than $38.5 million in any year when the total revenues for all locations are combined for each business (individual LDO or regional chain), and are not, therefore, included as small entities.
For the ESRD PPS updates in this final rule, a hospital-based ESRD facility (as defined by ownership type) is estimated to receive a 0.9 percent increase in payments for CY 2017. An independent facility (as defined by ownership type) is also estimated to receive a 0.7 percent increase in payments for CY 2017.
We are unable to estimate whether patients will go to ESRD facilities for AKI dialysis, however, we have estimated there is a potential for $2.0 million in payment for AKI dialysis treatments that could potentially be furnished in ESRD facilities. As a result, this final rule is not estimated to have a significant impact on small entities.
We estimate that of the 2,710 ESRD facilities expected to receive a payment reduction in the PY 2020 ESRD QIP, 341 are ESRD small entity facilities. We present these findings in Table 35 (“Estimated Distribution of PY 2020 ESRD QIP Payment Reductions”) and Table 37 (“Impact of Proposed QIP Payment Reductions to ESRD Facilities for PY 2020”) above. We estimate that payment reductions will average approximately $11,653 per facility across the 2,710 facilities receiving a payment reduction, and $13,675.56 for each small entity facility. Using our estimates of facility performance, we also estimated the impact of payment reductions on ESRD small entity facilities by comparing the total estimated payment reductions for 922 small entity facilities with the aggregate ESRD payments to all small entity facilities. We estimate that there are a total of 922 small entity facilities, and that the aggregate ESRD PPS payments to these facilities will decrease 0.48 percent in PY 2020.
We anticipate that the bid surety bond provision will have an impact on all suppliers, including small suppliers; therefore, we requested comments regarding the bid bond amount. No comments were received from small suppliers. The state licensure and appeal of preclusion rules are not expected to have an impact on any supplier.
We expect that finalizing our proposals for a method for adjusting DMEPOS fee schedule amounts for certain groupings of similar items with different features using information from the DMEPOS CBPs, our final change for submitting bids for a grouping of two or more similar items with different features, our final policy for determining single payment amounts for similar items with different features under the DMEPOS CBPs, and our revision to the bid limits for items under the DMEPOS CBP will not have a significant impact on a substantial number of small suppliers. Although suppliers furnishing items and services outside CBAs do not have to compete and be awarded contracts in order to continue furnishing these items and services, the fee schedule amounts for these items and services will be more equitable using the proposals established as a result of this rule. We believe that these rules will have a positive impact on suppliers because it reduces the burden and time it takes for suppliers to submit bids and data entry. It will also allow for suppliers to furnish items necessary to beneficiaries while getting compensated a reasonable payment.
Therefore, the Secretary has determined that this final rule would not have a significant economic impact on a substantial number of small entities. We solicited comments on the RFA analysis provided and did not receive comments.
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. Any such regulatory impact analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. We do not believe this final rule will have a significant impact on operations of a substantial number of small rural hospitals because most dialysis facilities are freestanding. While there are 139 rural hospital-based ESRD facilities, we do not know how many of them are based at hospitals with fewer than 100 beds. However, overall, the 139 rural hospital-based ESRD facilities will experience an estimated 0.1 percent increase in payments. As a result, this final rule is not estimated to have a significant impact on small rural hospitals. Therefore, the Secretary has determined 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 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2016, that is approximately $146 million. This final rule does not include any mandates that would impose spending costs on State, local, or Tribal governments in the aggregate, or by the private sector, of $141 million.
Executive Order 13132 on Federalism (August 4, 1999) establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. We have reviewed this final rule under the threshold criteria of Executive Order 13132, Federalism, and have determined that it will not have substantial direct effects on the rights, roles, and responsibilities of States, local or Tribal governments.
This final rule is subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801
In accordance with the provisions of Executive Order 12866, this final rule was reviewed by the Office of Management and Budget.
Health facilities, Kidney diseases, Medicare, Reporting and recordkeeping requirements.
Administrative practice and procedure, Health facilities, Health professions, Kidney diseases,
Medicare, Reporting and recordkeeping requirements
Conditions for coverage for end-stage renal disease facilities.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR chapter IV as set forth below:
42 U.S.C. 1302; 42 U.S.C. 1395d(d); 42 U.S.C. 1395f(b); 42 U.S.C. 1395g; 42 U.S.C. 1395l(a), (i), and (n); 42 U.S.C. 1395x(v); 42 U.S.C. 1395hh; 42 U.S.C. 1395rr; 42 U.S.C. 1395tt; 42 U.S.C. 1395ww; sec. 124 of Public Law 106-113, 113 Stat. 1501A- 332; sec. 3201 of Public Law 112-96, 126 Stat. 156; sec. 632 of Public Law 112-240, 126 Stat. 2354; sec. 217 of Public Law 113-93, 129 Stat. 1040; sec. 204 of Public Law 113-295, 128 Stat. 4010; and sec. 808 of Public Law 114-27, 129 Stat. 362.
(a) * * *
(1) A facility that disputes the amount of its allowable Medicare bad debts reimbursed by CMS under § 413.89(h)(3) may request review by the contractor or the Provider Reimbursement Review Board (PRRB) in accordance with subpart R to part 405 of this chapter.
(b) In addition to the per-treatment payment amount, as described in paragraph (a) of this section, the ESRD facility may receive payment for bad debts of Medicare beneficiaries as specified in § 413.89(h)(3).
This subpart implements section 1834(r) of the Act by setting forth the principles and authorities under which CMS is authorized to establish a payment amount for renal dialysis services furnished to beneficiaries with an acute kidney injury in or under the supervision of an ESRD facility that meets the conditions of coverage in part 494 of this chapter and as defined in § 413.171.
For purposes of the subpart, the following definition applies:
The amount of payment for AKI dialysis services shall be the base rate for renal dialysis services determined for such year under section 1881(b)(14), that is, the ESRD base rate as set forth in § 413.220, updated by the ESRD bundled market basket percentage increase factor minus a productivity adjustment as set forth in § 413.196(d)(1), adjusted for wages as set forth in § 413.231, and adjusted by any other amounts deemed appropriate by the Secretary under § 413.373.
The payment rate for AKI dialysis may be adjusted by the Secretary (on a budget neutral basis for payments under section 1834(r)) by any other adjustment factor under subparagraph (D) of section 1881(b)(14) of the Act.
(a) The AKI dialysis payment rate applies to renal dialysis services (as defined in subparagraph (B) of section 1881(b)(14) of the Act) furnished under Part B by a renal dialysis facility or provider of services paid under section 1881(b)(14) of the Act.
(b) Other items and services furnished to beneficiaries with AKI that are not considered to be renal dialysis services as defined in § 413.171, but that are related to their dialysis treatment as a result of their AKI, would be separately payable, that is, drugs, biologicals, laboratory services, and supplies that ESRD facilities are certified to furnish and that would otherwise be furnished to a beneficiary with AKI in a hospital outpatient setting.
(a) Changes to the methodology for payment for renal dialysis services furnished to beneficiaries with AKI as well as any adjustments to the AKI payment rate other than wage index will be adopted through notice and comment rulemaking.
(b) Annual updates in the AKI dialysis payment rate as described in § 413.372 that do not include those changes described in paragraph (a) of this section are announced by notice published in the
(c) Effective for cost reporting periods beginning on or after January 1, 2017, on an annual basis CMS updates the AKI dialysis payment rate.
Secs. 1102, 1871, and 1881(b)(1) of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(1)).
(g) * * *
(6)
(ii) The groupings of similar items subject to this rule include—
(A) Hospital beds (HCPCS codes E0250, E0251, E0255, E0256, E0260, E0261, E0290, E0291, E0292, E0293, E0294, E0295, E0301, E0302, E0303, and E0304).
(B) Mattresses and overlays (HCPCS codes E0277, E0371, E0372, and E0373)
(C) Power wheelchairs (HCPCS codes K0813, K0814, K0815, K0816, K0820, K0821, K0822, and K0823).
(D) Seat lift mechanisms (HCPCS codes E0627 and E0629).
(E) TENS devices (HCPCS codes E0720 and E0730).
(F) Walkers (HCPCS codes E0130, E0135, E0141, and E0143).
(iii) The weight for each item (HCPCS code) used in calculating the weighted average described in paragraph (g)(6)(ii) of this section is equal to the proportion of total nationwide allowed services furnished in calendar year 2012 for the item (HCPCS code) in the grouping of similar items, relative to the total nationwide allowed services furnished in calendar year 2012 for each of the other items (HCPCS codes) in the grouping of similar items.
(b) * * *
(2) The bids submitted for each item in a product category cannot exceed the payment amount that would otherwise apply to the item under subpart C of this part, without the application of § 414.210(g), or subpart D of this part, without the application of § 414.105, or subpart I of this part. The bids submitted for items in accordance with paragraph (d)(2) of this section cannot exceed the weighted average, weighted by total nationwide allowed services, as defined in § 414.202, of the payment amounts that would otherwise apply to the grouping of similar items under subpart C of this part, without the application of § 414.210(g), or subpart D of this part, without the application of § 414.105.
(d)
(2) An exception to paragraph (d)(1) of this section can be made in situations where price inversions defined in § 414.402 have occurred in past competitions for items within groupings of similar items within a product category. In these situations, an alternative method for submitting bids for these combinations of codes may be announced at the time the competition begins. Under this alternative method, the combination of codes for the similar items is the item for bidding purposes, as defined under § 414.402. Suppliers submit bids for the code with the highest total nationwide allowed services for calendar year 2012 (the “lead item”) within the grouping of codes for similar items, and the bids for this code are used to calculate the single payment amounts for this code in accordance with § 414.416(b)(1). The bids for this code would also be used to calculate the single payment amounts for the other codes within the grouping of similar items in accordance with § 414.416(b)(3). For subsequent competitions, the lead item is identified as the code with the highest total nationwide allowed services for the most recent and complete calendar year that precedes the competition. The groupings of similar items subject to this rule include—
(i) Hospital beds (HCPCS codes E0250, E0251, E0255, E0256, E0260, E0261, E0266, E0265, E0290, E0291, E0292, E0293, E0294, E0295, E0296, E0297, E0301, E0302, E0303, and E0304).
(ii) Mattresses and overlays (HCPCS codes E0277, E0371, E0372, and E0373).
(iii) Power wheelchairs (HCPCS codes K0813, K0814, K0815, K0816, K0820, K0821, K0822, K0823, K0824, K0825, K0826, K0827, K0828, and K0829).
(iv) Seat lift mechanisms (HCPCS codes E0627 and E0629).
(v) TENS devices (HCPCS codes E0720 and E0730).
(vi) Walkers (HCPCS codes E0130, E0135, E0140, E0141, E0143, E0144, E0147, E0148, and E0149).
(h)
(2)
(A) The name of the bidding entity as the principal/obligor;
(B) The name and National Association of Insurance Commissioners number of the authorized surety;
(C) CMS as the named obligee;
(D) The conditions of the bond as specified in paragraph (h)(3) of this section;
(E) The CBA covered by the bond;
(F) The bond number;
(G) The date of issuance; and
(H) The bid bond value of $50,000.00.
(ii) The bid surety bond must be maintained until it is either collected upon due to forfeiture or the liability is returned for not meeting bid forfeiture conditions.
(3)
(ii) Where the bid(s) does not meet the specified forfeiture conditions in paragraph (h)(3)(i) of this section, the bid surety bond liability will be returned within 90 days of the public announcement of contract suppliers for the CBA. CMS will notify the bidding entity that it did not meet the specified forfeiture requirements and the bid surety bond will not be collected by CMS.
(4)
(ii) A bidding entity, whose composite bid is at or below the median composite bid rate, that—
(A) Accepts a contract award; and
(B) Is found to be in breach of contract for nonperformance of the contract to avoid forfeiture of the bid surety bond will have its contract terminated and will be precluded from participation in the in the next round of the DMEPOS Competitive Bidding Program.
(b) * * *
(3) Each supplier must have all State and local licenses required to perform the services identified in the request for bids. CMS may not award a contract to any entity in a CBA unless the entity meets applicable State licensure requirements.
(b) * * *
(3) In the case of competitions where bids are submitted for an item that is a combination of codes for similar items within a product category as identified under § 414.412(d)(2), the single payment amount for each code within the combination of codes is equal to the single payment amount for the lead item or code with the highest total nationwide allowed services multiplied by the ratio of the average of the 2015 fee schedule amounts for all areas (
(g)
(2) In the event a contract supplier breaches its contract, CMS may take one or more of the following actions, which will be specified in the notice of breach of contract:
(i) Suspend the contract supplier's contract;
(ii) Terminate the contract;
(iii) Preclude the contract supplier from participating in the competitive bidding program; or
(iv) Avail itself of other remedies allowed by law.
This section implements an appeals process for suppliers that CMS has determined are in breach of their Medicare DMEPOS Competitive Bidding Program contract and where CMS has issued a notice of breach of contract indicating its intent to take action(s) pursuant to § 414.422(g)(2).
(a)
(b)
(2)
(i) The details of the breach of contract.
(ii) The action(s) that CMS is taking as a result of the breach of the contract pursuant to § 414.422(g)(2), and the duration of or timeframe(s) associated with the action(s), if applicable.
(iii) The right to request a hearing by a CBIC hearing officer and, depending on the nature of the breach, the supplier may also be allowed to submit a corrective action plan (CAP) in lieu of requesting a hearing by a CBIC hearing officer, as specified in paragraph (c)(1)(i) of this section.
(iv) The address to which the written request for a hearing must be submitted.
(v) The address to which the CAP must be submitted, if applicable.
(vi) The effective date of the action(s) that CMS is taking is the date specified by CMS in the notice of breach of contract, or 45 days from the date of the notice of breach of contract unless:
(A) A timely hearing request has been filed; or
(B) A CAP has been submitted within 30 days of the date of the notice of breach of contract where CMS allows a supplier to submit a CAP.
(c)
(ii) If a supplier chooses not to submit a CAP, if CMS determines that a supplier's CAP is insufficient, or if CMS does not allow the supplier the option to submit a CAP, the supplier may request a hearing on the breach of contract action(s).
(2)
(ii) Suppliers will have the opportunity to submit a CAP when they are first notified that they have been determined to be in breach of contract. If the CAP is not acceptable to CMS or is not properly implemented, suppliers will receive a subsequent notice of breach of contract. The subsequent notice of breach of contract may, at CMS' discretion, allow the supplier to submit another written CAP pursuant to paragraph (c)(1)(i) of this section.
(d)
(1) For the supplier to remedy all of the deficiencies that were identified in the notice of breach of contract.
(2) To identify the timeframes by which the supplier will implement each of the components of the CAP.
(e)
(2) If CMS accepts the CAP, including the supplier's designated timeframe for its completion, the supplier must provide a follow-up report within 5 days after the supplier has fully implemented the CAP that verifies that all of the deficiencies identified in the CAP have been corrected in accordance with the timeframes accepted by CMS.
(3) If the supplier does not implement a CAP that was accepted by CMS, or if CMS does not accept the CAP submitted by the supplier, then the supplier will receive a subsequent notice of breach of contract, as specified in paragraph (b) of this section.
(f)
(2) A supplier that wishes to appeal the breach of contract action(s) specified in the notice of breach of contract must submit a written request to the CBIC. The request for a hearing must be received by the CBIC within 30 days from the date of the notice of breach of contract.
(3) A request for hearing must be in writing and submitted by an authorized official of the supplier.
(4) The appeals process for the Medicare DMEPOS Competitive Bidding Program is not to be used in place of other existing appeals processes that apply to other parts of Medicare.
(5) If the supplier is given the opportunity to submit a CAP and a CAP is not submitted and the supplier fails to timely request a hearing, the breach of contract action(s) will take effect 45 days from the date of the notice of breach of contract.
(g)
(2) The hearing may be held in person or by telephone at the parties' request.
(3) The scheduling notice to the parties must indicate the time and place for the hearing and must be sent to the parties at least 30 days before the date of the hearing.
(4) The hearing officer may, on his or her own motion, or at the request of a party, change the time and place for the hearing, but must give the parties to the hearing 30 days' notice of the change.
(5) The hearing officer's scheduling notice must provide the parties to the hearing the following information:
(i) A description of the hearing procedure.
(ii) The specific issues to be resolved.
(iii) The supplier has the burden to prove it is not in violation of the contract or that the breach of contract action(s) is not appropriate.
(iv) The opportunity for parties to the hearing to submit additional evidence to support their positions, if requested by the hearing officer.
(v) A notification that all evidence submitted, both from the supplier and CMS, will be provided in preparation for the hearing to all affected parties at least 15 days prior to the scheduled date of the hearing.
(h)
(2) The supplier's evidence must be submitted with its request for a hearing.
(3) If the supplier fails to submit the evidence at the time of its submission, the Medicare DMEPOS supplier is precluded from introducing new evidence later during the hearing process, unless permitted by the hearing officer.
(4) CMS also has the opportunity to submit evidence to the hearing officer within 10 days of receiving the scheduling notice.
(5) The hearing officer will share all evidence submitted by the supplier and/or CMS, with all parties to the hearing at least 15 days prior to the scheduled date of the hearing.
(i)
(1) Conduct the hearing and decide the order in which the evidence and the arguments of the parties are presented;
(2) Determine the rules on admissibility of the evidence;
(3) Examine the witnesses, in addition to the examinations conducted by CMS and the contract supplier;
(4) The CBIC may assist CMS in the appeals process including being present at the hearing, testifying as a witness, or performing other, related ministerial duties;
(5) Determine the rules for requesting documents and other evidence from other parties;
(6) Ensure a complete record of the hearing is made available to all parties to the hearing;
(7) Prepare a file of the record of the hearing which includes all evidence
(8) Comply with all applicable provisions of 42 U.S.C. Title 18 and related provisions of the Act, the applicable regulations issued by the Secretary, and manual instructions issued by CMS.
(j)
(2) The recommendation(s) will explain the basis and the rationale for the hearing officer's recommendation(s).
(3) The hearing officer must include the record of the hearing, along with all evidence and documents produced during the hearing along with its recommendation(s).
(k)
(2) After reviewing the hearing officer's recommendation(s), CMS' decision(s) will be made within 30 days from the date of receipt of the hearing officer's recommendation(s). In situations where there is more than one breach of contract action presented at the hearing, and the hearing officer issues multiple recommendations, CMS will render separate decisions for each breach of contract action.
(3) A notice of CMS' decision will be sent to the supplier and the hearing officer. The notice will indicate:
(i) If any breach of contract action(s) included in the notice of breach of contract, specified in paragraph (b)(1) of this section, still apply and will be effectuated, and
(ii) The effective date for any breach of contract action specified in paragraph (k)(3)(i) of this section.
(4) This decision(s) is final and binding.
(l)
(ii) The supplier must notify all beneficiaries who are receiving rented competitive bid items or competitive bid items on a recurring basis of the suspension of their contract.
(A) The notice to the beneficiary from the supplier must be provided within 15 days of receipt of the final notice.
(B) The notice to the beneficiary must inform the beneficiary that they must select a new contract supplier to furnish these items in order for Medicare to pay for these items.
(2)
(ii) The supplier must notify all beneficiaries, who are receiving rented competitive bid items or competitive bid items received on a recurring basis, of the termination of their contract.
(A) The notice to the beneficiary from the supplier must be provided within 15 days of receipt of the final notice of termination.
(B) The notice to the beneficiary must inform the beneficiary that they are going to have to select a new contract supplier to furnish these items in order for Medicare to pay for these items.
(3)
(4)
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
(a) * * *
(3) Section 1861(s)(2)(F) of the Act, which describes “medical and other health services” covered under Medicare to include home dialysis supplies and equipment, self-care home dialysis support services, and institutional dialysis services and supplies, for items and services furnished on or after January 1, 2011, renal dialysis services (as defined in section 1881(b)(14)(B)), including such renal dialysis services furnished on or after January 1, 2017, by a renal dialysis facility or provider of services paid under section 1881(b)(14) to an individual with acute kidney injury (as defined in section 1834(r)(2)).
(7) Section 1861(s)(2)(F) of the Act, which authorizes coverage for renal dialysis services furnished on or after January 1, 2017 by a renal dialysis facility or provider of services currently paid under section 1881(b)(14) of the Act to an individual with AKI.
National Park Service, Interior.
Final rule.
We are updating our service-wide regulations governing the exercise of non-federal oil and gas rights, to improve our ability to protect park resources, values, and visitors from potential impacts associated with nonfederal oil and gas operations located within National Park Service units outside Alaska. The rule also makes the regulations consistent with existing policies and practices, and updates the format to improve clarity and simplify application and compliance for oil and gas operators and our employees.
This rule is effective December 5, 2016.
Edward O. Kassman, Jr., Geologic Resources Division, National Park Service, P.O. Box 25287, Denver, Colorado 80225;
On October 26, 2015, the National Park Service (NPS) published the proposed rule in the
At the start of the comment period, the NPS distributed over 1,000 newsletters to non-governmental organizations, individuals, industry groups, Alaska native corporations, and state agencies, primarily the oil and gas regulatory agencies from multiple states (Alaska, Alabama, California, Colorado, Florida, Indiana, Kentucky, Kansas, Louisiana, Mississippi, Montana, New Mexico, North Dakota, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, West Virginia, Wyoming). These newsletters summarized the proposed rule, alternatives considered in the related draft environmental impact statement (DEIS), and how the public could comment on the proposed rule and DEIS. In an effort to reach an even broader audience, the NPS hosted a pre-recorded webinar describing the proposed rulemaking. This online webinar soliciting public comment on the DEIS and the proposed rule and was open to any member of the public.
The NPS received 20 comment letters on the proposed rule during the comment period. These included unique comment letters and form letters. Some comment letters received were submitted improperly and not considered. Additionally, many comments were signed by more than one person. NPS counted a letter as a single set of comments, regardless of the number of signatories. A summary of comments and NPS responses is provided below in the section entitled “Summary of and Responses to Public Comments.”
After considering the public comments and additional review, the NPS made changes in the final rule. These changes are summarized below in the section entitled “Changes in the Final Rule.”
On December 8, 1978, the NPS promulgated the regulations at 36 CFR part 9, subpart B (43 FR 57825) (1978 Regulations), governing the exercise of non-federal oil and gas rights in units of the National Park System (System units).
The 1978 Regulations applied to all activities associated with non-federal oil and gas exploration and development inside System unit boundaries where access is on, across, or through federally owned or controlled lands or waters (36 CFR 9.30(a)). Under the 1978 Regulations, an operator utilizing such access must obtain our approval of a plan of operations before commencing non-federal oil and gas operations in a System unit (36 CFR 9.32(b)). This requirement covered exploration, drilling, production, transportation, plugging, and reclamation operations.
The proposed plan of operations was an operator's blueprint of all intended activities and was our primary means for evaluating the operation's potential adverse impacts on park resources and values. The operator must demonstrate that it is exercising a bona fide property right to non-federal oil and gas located within a System unit (36 CFR 9.36(a)(2)). Generally, the proposed plan of operations must also describe:
• The proposed operation, including the equipment, methods, and materials to be used in the operation;
• Access to the site;
• Mitigation measures that will be implemented to protect NPS resources and values;
• Environmental conditions in the vicinity of the site;
• Alternatives to the proposal; and
• The environmental impacts of the proposed operation (36 CFR 9.36(a)).
In addition to the proposed plan of operations, and prior to approval, the operator must submit a performance bond to ensure that funds are available to reclaim a site if the operator defaults on its obligations under an approved plan (36 CFR 9.48). In order to make the regulatory process as efficient and transparent as possible, we work collaboratively with operators early in their planning process to provide guidance on information requirements, alternative area of operations locations, and potential mitigation and avoidance measures.
During our approval process, we coordinate and consult with a variety of state and other federal regulatory agencies to ensure that approval complies with applicable laws, such as the National Environmental Policy Act of 1969, the Endangered Species Act, the National Historic Preservation Act, and the Clean Water Act.
The 1978 Regulations required that operators conducting non-federal oil and gas operations in System units provide an affidavit that operations planned are in compliance with all applicable state and local laws (36 CFR 9.36(a)(15)). Although state oil and gas regulations may contain provisions designed to protect natural resources (
When the NPS Regional Director has determined that the proposal meets the requirements contained in the regulations and the NPS has completed the required environmental compliance, the Regional Director will approve the plan (36 CFR 9.37). The approved plan is the operator's authorization to conduct its operation in a System unit (36 CFR 9.32(a)).
During the life of an oil or gas operation in a park, the park manager has the authority to monitor and ensure compliance with the approved plan of operations (36 CFR 9.37(f)). If there is a change in circumstances, the NPS or the operator can make a request to supplement or modify the plan (36 CFR
The authority to promulgate these regulations is the statute commonly known as the NPS Organic Act (54 U.S.C. 100101
In addition, the enabling acts for several System units contain specific provisions directing or authorizing us to regulate the exercise of non-federal oil and gas rights. In the authority section of the rule, we list the individual enabling statutes that address non-federal oil and gas rights in those System units.
Our authority to promulgate regulations that govern the exercise of non-federal oil and gas operations has been recognized as a valid exercise of NPS's Organic Act authority by a U.S. District Court and the United States Court of Appeals for the Fifth Circuit. See
System units in Alaska would have been subject to the regulations in the proposed rule. As explained in the preamble to the proposal, we relied upon
The rule has no effect on the above-referenced regulations at 43 CFR part 36, promulgated by the Department of the Interior in 1986 to implement section 1110(b) of ANILCA, which apply to persons who use lands and waters administered by NPS to conduct activities on, or for access to, non-federal inholdings within Alaska parks.
A unique provision exists under section 8 of the Big Cypress National Preserve Addition Act of 1988 (Addition Act), codified at 16 U.S.C. 698m-4. In addition to authorizing the Secretary to promulgate rules and regulations specifically for Big Cypress National Preserve, the Addition Act authorized the Secretary to enter into interim agreements with owners of non-Federal oil and gas interests governing the conduct of oil and gas exploration, development, or production activities within the boundary of the Addition. 16 U.S.C. 698m-4(e). Such agreements had been interpreted to obviate the need for operators to propose a plan of operations under the 1978 Regulations for their operations on the Addition lands.
Consistent with the statute, the present oil and gas operations within the Addition Area had been controlled under the terms of the Agreement Governing The Exercise Of Reserved Oil And Gas Rights Of Collier Enterprises And Barron Collier Company, which is Appendix 6 to the Agreement Among the United States of America, Collier Enterprises, Collier Development Corporation, and Barron Collier Company (May 12, 1988). This rule supersedes Appendix 6.
Non-federal oil and gas rights exist within System units in situations where the United States does not own the oil and gas interest, either because:
• The United States acquired the property from a grantor that did not own the oil and gas interest; or
• The United States acquired the property from a grantor that reserved the oil and gas interest from the conveyance.
Non-federal oil and gas interests can be held by individuals; nonprofit organizations; corporations; or state and local governments. Interests in non-federal oil and gas are property rights that may only be taken for public use with payment of just compensation in accordance with the Fifth Amendment of the U.S. Constitution.
Accordingly, from their initial promulgation, the 1978 Regulations at 36 CFR 9.30(a) have stated that they are “not intended to result in the taking of a property interest, but rather to impose reasonable regulations on activities that involve and affect federally owned lands.” This rule includes this same provision.
There are currently 534 non-federal oil and gas operations in a total of 12 System units. These units are: Alibates Flint Quarries National Monument, Texas (5 operations); Aztec Ruins National Monument, New Mexico (4 operations); Big Cypress National Preserve, Florida (20 operations); Big Thicket National Preserve, Texas (39 operations); Big South Fork National River and Recreation Area, Tennessee/Kentucky (152 operations); Cumberland Gap National Historical Park, Tennessee (2 operations); Cuyahoga Valley National Park, Ohio (90 operations); Gauley River National Recreation Area, West Virginia (28 operations); Lake Meredith National Recreation Area, Texas (174 operations); New River Gorge National River, West Virginia (1 operation; Obed Wild and Scenic River, Tennessee (5 operations); and Padre Island National Seashore, Texas (14 operations).
Based on the presence of split estates, exploration and production occurring on adjacent or nearby lands, and likely increases in energy prices, NPS expects that future non-federal oil and gas operations within park boundaries could occur in up to 30 additional System units.
Examples of non-federal oil and gas activities conducted in System units include geophysical (seismic) exploration; exploratory well drilling; field development well drilling; oil and gas well production operations, including installation and operation of well flowlines and gathering lines; well plugging and abandonment; and site reclamation.
Such oil and gas activities may adversely impact System unit resources in various ways:
• Surface water quality degradation from spills, storm water runoff, erosion, and sedimentation. Through site inspections the NPS has documented 26 instances of in-park operation sites with surface contamination;
• Soil and ground water contamination from existing drilling mud pits, poorly constructed wells, spills, and leaks. Through site inspections the NPS has documented 47 instances of sites with wellhead leaks, pump jack leaks, tank battery leaks, and operations and maintenance spills;
• Air quality degradation from dust, natural gas flaring, hydrogen sulfide gas, and emissions from production operations and vehicles. Through site inspections the NPS has documented 14 instances of notable odors emanating from the wellhead;
• Noise from seismic operations, blasting, construction, oil and gas drilling and production operations. Through site inspections the NPS has documented 6 instances of excess noise issues from well pad equipment;
• Noise and human presence effects on wildlife behavior, breeding, and habitat utilization;
• Disruption of wildlife migration routes;
• Adverse effects on sensitive and endangered species. Through site inspections the NPS has documented 15 sites with sensitive species or habitat;
• Viewshed intrusion by roads, traffic, drilling equipment, production equipment, pipelines, etc.;
• Night sky intrusion from artificial lighting and gas flares;
• Disturbance to archeological and cultural resources from blasting associated with seismic exploration and road/site preparation, maintenance activities, or by spills. Through site inspections the NPS has documented 6 sites with associated cultural resources; and
• Visitor safety hazards from equipment, pressurized vessels and lines, presence of hydrogen sulfide gas, and leaking oil and gas that can create explosion and fire hazards. Through site inspections the NPS has documented 62 instances of visitor safety hazards.
Examples of documented impacts can be found in many parks. For example, at Big South Fork natural-gas-fired pump jack engines can be heard at visitor overlooks that are 2 to 3 miles away. Simple mitigation such as a corrugated steel fence around the operations would abate this impact; however, due to the well's grandfathered status, the NPS has been unable to require this mitigation and is therefore forced to accept this adverse impact.
Another example of avoidable impacts was found at Aztec Ruins National Monument where an operation exempt from the 1978 Regulations due to the grandfathered exemption contained a road that traversed an unexcavated archeological site. Only when this well lost its grandfathered status due to a change of operator was the NPS able to require the new operator to conduct a cultural resource survey to determine the impacts to the site. As mitigation the operator installed a layer of dirt between the archeological site and the road base to protect the resources.
The summary below details the significant differences between the 1978 Regulations and this final rule. As appropriate, this summary also briefly describes the reasons changes were made to this rule as a result of public comments received.
After careful review we have found that the 1978 Regulations were inconsistent in their description of the interests that the regulations were designed to protect. This rule at § 9.30(a) and throughout consistently states that the purpose of the regulations is to protect federally owned or administered lands, waters, or resources of System units, visitor uses or experiences, and visitor or employee health and safety. The NPS evaluates operators' proposals on a case-by-case basis and applies avoidance and mitigation measures and requires financial assurance amounts to the extent necessary to protect the interests described above. Depending on the type of activity proposed, environmental factors, visitor use patterns, and land ownership status (activity either on federal or non-federal lands), the NPS will adjust its avoidance and mitigation measures and financial assurance amounts accordingly.
This rule replaces the phrase “federally owned or controlled” with the phrase “federally owned or administered” to be consistent with the terminology we use in our general regulations, at 36 CFR 1.2, and 36 CFR 1.4(a) (definition of “National Park System”).
Under § 9.30(a) of the 1978 Regulations, application of the rule was predicated on “access on, across, or through federally owned or controlled lands or waters.” This rule at 9.30(b) applies to all operators conducting non-federal oil or gas operations on lands or waters within a System unit, regardless of the ownership or legislative jurisdictional status of those lands or waters.
Section 9.30(c) of this rule retains language from § 9.30(a) of the 1978 Regulations stating that the intention of this subpart is to reasonably regulate non-federal oil and gas activities in a System unit, but not to result in a taking of private property. Although the NPS has required mitigation measures on proposed operations, we have never, in the more than 37 years of applying this subpart, failed to approve a plan of operations. We will continue to work with operators to ensure they have reasonable access to their oil and gas rights while protecting park resources and values without resulting in a taking in violation of the Fifth Amendment of the United States Constitution.
Section 9.31(a) of this rule changes the scope to cover all nonfederal oil and gas operations within the boundary of a System unit outside of Alaska. Section 9.31(b) of this rule also covers those operations that become located within a System unit either by statutory boundary expansion or establishment of a new System unit. Section 9.31(c) of this rule covers those operations that access oil and gas rights from a surface location outside the park boundary but due to a boundary expansion or
Section 9.32(a) of this rule provides that an operator must have either a temporary access permit before conducting reconnaissance surveys on NPS administered lands or an operations permit for operations in a System unit.
The 1978 Regulations contained a requirement that operators demonstrate that they hold valid rights to conduct activities under the plan of operations information requirements. This rule moves this requirement to § 9.32(b) to clarify that all operators must demonstrate up front that they hold a valid existing right to conduct operations in a System unit. Until an operator can demonstrate a valid existing right to conduct all operations described in its operation permit application, we will not undertake formal review of an operator's operations permit application.
This rule deletes several redundant definitions because the terms are defined at 36 CFR 1.4. The definitions being deleted from the 1978 Regulation are: “Secretary” (former § 9.31(a)), “Director” (former § 9.31(b)), “Person” (former § 9.31(e)), and “Superintendent” (former § 9.31(f)). This rule also deletes two definitions that are no longer used: “Commercial Vehicle” (former § 9.31(g)) and “Statement for Management” (former § 9.31(o)).
This rule adds a new term, “Area of Operations,” to replace the term “Site,” at former § 9.31(m). The new term means all areas where an operator is authorized to conduct its activities, including access to the operations site.
This rule expands the definition of “Contaminating Substances,” at former § 9.31(n), to include other toxic or hazardous substances. This definition no longer uses the term “waste,” and the rule includes a separate definition of “waste.”
This rule deletes the term “Unit” and instead the text of the rule uses the statutory term “System unit,” which is defined at 54 U.S.C. 100102(6).
This rule changes the definition of “Operations” at § 9.31(c) of the 1978 Regulation, to clarify that “access” includes “any means of ingress to or egress from an area of operations.” This change covers any and all types of access, including access via aircraft (time, place, and manner of aircraft landing on or taking off) to an area of operations. Accordingly, the NPS removed former § 9.32(c), which regulated 9B aircraft access.
The definition of “Operations” under this rule also clarifies that the operation of a flowline or a gathering line is included within this definition, but not the installation, operation, or maintenance of trans-park oil and gas pipelines that are under authority of a deeded easement or other right-of-way and which are not covered by this regulation.
This rule adds a new term “Operations permit” as the permitting instrument for all operations. An operations permit is a special use permit subject to cost recovery under 54 U.S.C. 103104, which authorizes the NPS to recover all costs associated with providing necessary services associated with special use permits.
This rule updates the definition of “Operator” at § 9.31(d) of the 1978 Regulations by clarifying that responsibilities and liability under this subpart can attach to the operator or the operator's agents, assignees, designees, lessees, or representatives.
This rule defines “owner” as a “person” (the definition of “person” is found at 36 CFR 1.4).
This rule adds a new definition of “Previously exempt operation” to clarify which types of operations are covered under §§ 9.50 through 9.53. This definition does not include those operations where the operator was granted an exemption under § 9.32(e) of the 1978 Regulations to the plan of operations requirement by the NPS because it accessed oil and gas rights inside the park boundary from a surface location outside the park boundary (which are covered by § 9.33(b) of this rule).
This rule adds a new term “Reconnaissance survey” to clarify that reconnaissance surveys do not include surface disturbance activities, except the minimal disturbance necessary to perform the surveys.
This rule adds a new term “Right to operate” that incorporates much of the language in § 9.36(a)(2) of the 1978 Regulations (right to operate description for a Plan of Operations). This new definition clarifies that an operator's documentation must demonstrate that all proposed activities are within the scope of that right.
This rule adds a new term “Technologically feasible, least damaging methods” to describe the general standard that all operators must satisfy when meeting applicable operating standards.
This rule adds a new term “Temporary access permit” to clarify that the NPS grants temporary access only for reconnaissance surveys and to collect basic information necessary to prepare a permit application.
This rule adds a new term “Third-party monitor” to identify a third-party monitor's necessary qualifications.
This rule adds a new term “Usable water” to describe the criteria that the NPS uses to identify protected sources of groundwater.
This rule adds a new term “Waste” to differentiate between “waste” and “contaminating substances.” Further, the NPS changed the definition of Waste from the proposed rule by replacing the term “toxic or hazardous substance” with the phrase “contaminating substance” to more clearly explain the differences between wastes and contaminating substances.
This rule adds a new set of terms “We and us” to refer to the National Park Service.
This rule adds a definition of “You” to be consistent with the plain language format of this subpart.
This rule deletes former § 9.32(d). This access is controlled by NPS commercial vehicle regulations at 36 CFR 5.6(c).
This rule creates a new section “Previously Exempt Operations” to describe the process for bringing exempt operations under the 1978 Regulations into compliance with the requirements of this rule. These include operations that do not require access on, across, or through federal lands (former § 9.30) and grandfathered operations (former § 9.33).
The 1978 Regulations applied only when an operator's “access [was] on, across, or through federally owned or controlled lands or waters.” Seventy-eight current operations (15% of all oil and gas operations in System units) did not require access on, across, or through federally owned or controlled lands or waters and thus were not covered by the 1978 Regulations. These operators were not required to obtain an approved NPS plan of operations, post financial assurance, or otherwise comply with this subpart to protect park resources and values. However, our experience over the past three decades has demonstrated that these operations have the potential to adversely affect NPS resources, values, and visitor health and
Under this rule at §§ 9.30 through 9.33, all operators conducting operations within NPS boundaries are subject to permit requirements. The permitting process includes an evaluation to determine whether, and the extent to which, such operations would have an adverse effect on federally owned or administered lands, waters, or resources of System units, visitor uses or experiences, or visitor or employee health and safety. These operations are also subject to measures to mitigate such adverse effects, as well as to the financial assurance and reclamation requirements.
Under § 9.33 of the 1978 Regulations, operators who were conducting operations at the time the regulations became effective (January 8, 1979) and who had already obtained any valid federal or state permit were “grandfathered.” These operators were not required to obtain an approved plan of operations; comply with NPS operating standards, including reclamation of their area of operations to NPS standards; or post a reclamation bond. The Superintendent had authority under § 9.33(c) of the 1978 Regulations to suspend grandfathered operations if there was an “immediate threat of significant injury to federally owned or controlled lands or waters.” Under § 9.33(a)(1) of the 1978 Regulations, when the existing federal or state permit expired and was replaced with a new permit, a plan of operations would then be required.
In 1978, the NPS had expected that over time the permits associated with these operations would expire and that the operators would then be required to come into compliance with the 1978 Regulations. However, the rate of permit expiration has been much slower than anticipated. This has resulted in approximately 45% of operations (241 wells service-wide) remaining exempt from the regulations despite the passage of over thirty-seven years. As discussed above, this has resulted in readily avoidable impacts to NPS-administered resources and values. The grandfather exemption was intended to provide for a “smooth and fair phase in of [the 1978] regulations.” (43 FR 57822) This rulemaking is intended to ensure that all operations within System units are conducted in a manner that protects park resources and values. This rule in §§ 9.50 through 9.53 sets forth the procedure for bringing previously exempt operations into compliance.
This rule requires an operator to obtain a temporary access permit in order to conduct reconnaissance surveys on NPS administered lands and waters and removes provisions from the 1978 Regulations that allowed the NPS to authorize temporary access for existing operations and for new operations. Those provisions are no longer necessary because operations within the boundary of a System unit are required to obtain an Operations Permit. This rule identifies at §§ 9.60 through 9.63 the procedure for obtaining a temporary access permit and what information is necessary for the NPS to evaluate an operator's proposal. No comments were received on this provision of the proposed rule.
Section 9.32(e) of the 1978 Regulations allowed operators to apply for an exemption from the regulations if they directionally drilled from a surface location outside a System unit to reach a bottom hole located within NPS boundaries and the drillbore passed under any land or water the surface of which was owned by the United States. This exemption was available if operations within the park boundary posed no significant threat of damage to NPS resources, both surface and subsurface, resulting from surface subsidence, fracture of geological formations with resultant fresh water aquifer contamination, or natural gas escape. Surface activities located outside the NPS boundary were not within the scope of the 1978 Regulations. Under this regulation, regulatory authority over these operations is exercised beginning at the subsurface point where the proposed operation (borehole) crosses the park boundary, and applies to all infrastructure and activities within the System unit regardless of the ownership of the surface estate. NPS will review your proposed operations and provide an exemption from the operations permit requirement whenever it determines that your downhole operations within the park boundary do not pose a significant threat to park resources or park visitors. For further guidance on applying for an exemption for such operations, please see the 9B Operator's Handbook.
The availability of the exemption is intended to continue to provide an incentive for operators to locate surface facilities outside a System unit. Location of operations outside a System unit generally avoids direct impacts to NPS resources and visitors. Therefore, this rule at § 9.70 is consistent with the concepts that underlay the former rule exemption, but operators are subject to the General Terms and Conditions and the Prohibitions and Penalties provisions for operations located within the boundary of a System unit.
This rule details the information requirements that an operator must satisfy when submitting a complete Operations Permit application. These requirements are separated into the following categories: § 9.83, information that must be included in all applications; § 9.87, additional information that must be included for a proposed geophysical exploration; § 9.88, additional information that must be included for a proposed drilling operations; § 9.89 additional information must be included for a proposed well stimulation operations, including hydraulic fracturing; and, § 9.90 additional information that must be included for a proposed production operations.
This rule contains the following new or updated information requirements from the 1978 Regulations for all operations permit applications:
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• The NPS has updated language from the proposed rule at § 9.84(a)(2) to add “wetlands, seepage areas, springs, shallow water aquifers, . . .” to the example list of natural features.
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This rule at § 9.87 clarifies the additional information a geophysical operator must submit to the NPS. Furthermore, this rule at §§ 9.88 through 9.90 clarifies the additional information an operator must submit if it is proposing to drill, stimulate, or produce a well. The final rule adds language to §§ 9.88 and 9.89 of the proposed rule to include any proposed stimulation technique including hydraulic fracturing.
This rule also contains, § 9.89, a new set of information requirements for well stimulation, including hydraulic fracturing operations. Information requirements include identifying the geologic barriers between the target zone and the deepest usable water zone, verifying mechanical integrity of the wellbore, and describing water use and disposal management of flowback fluids. The NPS rule is similar to BLM's hydraulic fracturing information requirements at 43 CFR 3162.3-3(d)(1) through (7), which BLM recently promulgated under various authorities, including the Mineral Leasing Act, 30 U.S.C. 189, the Federal Land Policy and Management Act, 43 U.S.C. 1701
Section 9.37(a)(1) of the 1978 Regulations required that, before approving a plan of operations, the Regional Director determine that the operator uses technologically feasible, least damaging methods that provide for protection of the park's resources and public health and safety.
The 1978 Regulations had two different approval standards, depending on whether the operation was proposed on non-federally or federally owned surface. For operations proposed on non-federally owned surface a Regional Director could not approve an operation that would constitute a nuisance to federal lands or waters in the vicinity of the operations, or would significantly injure federally owned or controlled lands or waters. For operations proposed on federally owned surface a Regional Director could not approve an operation that would substantially interfere with management of the unit to ensure the preservation of its natural and ecological integrity in perpetuity, or would significantly injure federally owned or controlled lands or waters. If applying the standard for operations proposed on federally owned lands would constitute a taking of a property interest, the NPS could have either approved the operations if the operator used technologically feasible, least damaging methods or acquire the mineral interest.
Section 9.37(b) and (c) of the 1978 Regulations required the NPS to make a decision on the plan of operations within 60 days after the date that the NPS determines that the materials submitted under the plan are adequate. Within 60 days, the Regional Director was required to make one of six final decisions in writing. The final decisions were: approval or rejection; conditional approval; modification to the plan or additional information is required; more time is necessary to complete review; environmental statement is required before approval; or more time is necessary for public participation and analysis of public comments.
Section 9.37(c) of the 1978 Regulations provided that failure of the NPS to make a final decision within 60 days constituted a rejection of the plan for which the operator had the option of appealing immediately to the Regional Director under former § 9.49.
This rule establishes a two-stage permit application review process, eliminates the dual approval standards, provides more realistic timeframes to provide notice back to an operator, and consolidates the final decisions the NPS can make on an operator's permit application.
Section 9.101 of this rule describes the NPS's initial review of an operator's permit application. During initial review the NPS determines whether the applicant has supplied all information necessary for the NPS to evaluate the operation's potential impacts on federally owned or administered lands, waters, or resources of System units, visitor uses or experiences, or visitor or employee health and safety. The NPS will respond to applicants in writing within 30 days and notify them whether the information contained in their permit applications is complete. If the NPS needs more time to complete the initial review, the NPS will provide the applicant with an estimate of the amount of additional time reasonably needed and an explanation for the delay. Once a permit application is complete the NPS conducts a formal review.
During formal review under § 9.102, the NPS evaluates whether the proposed operation meets the NPS approval standards (§ 9.103) and complies with applicable federal statutes (
In light of NPS experience over the past 37 years in implementing the 1978 Regulations, the 60-day period for reaching a final decision on a permit application has proven to be unrealistic. These decisions require time to adequately analyze an operator's proposal, work with the operator on a
This rule removes § 9.37(c) of the 1978 Regulations, which allowed an operator to immediately appeal the failure to reach a decision within 60 days. This rule, at § 9.104, authorizes the Superintendent to notify the operator in writing that additional time is necessary to make a final decision.
Section 9.103 replaces the dual approval standards under the 1978 Regulations with a single three-part approval standard that applies to all operations, regardless of surface ownership. Oil and gas operations located on non-federally owned surface have the potential to impact federally owned or administered lands, waters, or resources of System units, visitor uses or experiences, or visitor or employee health and safety to the same degree as operations sited on federally owned surface.
Section 9.103(a) of the proposed rule has been changed in two ways. First, in response to comment the NPS changed the introductory language to expressly provide that if an operator meets the approval standards, the Regional Director will approve the operation permit. Second, this section lists two (rather than three) determinations that the Regional Director must make in order to approve an operations permit. The NPS clarified the language in § 9.103(a)(1) to include statutes that may apply to operations in particular System units. The NPS also removed language in paragraph (b)(3) in the proposed rule that required the Regional Director to make a “determination” that an operator was in compliance with all other applicable federal, state, and local laws. Rather, as a prerequisite to approval of an operations permit, the modified language requires that the operator provide the Regional Director with an affidavit stating that it is in compliance with all applicable federal, state, and local laws.
Thus, revised § 9.103(b) requires three prerequisites for final approval: (1) Submittal of adequate financial assurance, (2) proof of adequate liability insurance, and (3) an affidavit stating that the operations planned are in compliance with all applicable Federal, State, and local laws and regulations.
Section 9.104 of this rule establishes two final actions: (1) Approved, with or without conditions, or (2) denial, and the justification for the denial. The Regional Director will notify the operator in writing of the final action. If approved, this written notification constitutes the NPS's authorization to conduct activities. The NPS has simplified the language at § 9.104(a)(2) to read “all applicable legal requirements.”
The NPS has eliminated the proviso in the approval standard in current § 9.37(a)(3) of the 1978 Regulations, which allows for approval using only the “technologically feasible, least damaging methods” standard of § 9.37(a)(1) if application of the more stringent § 9.37(a)(3) standard would cause a taking of a property interest. Over the past 37 years of implementing the 1978 Regulations, the NPS has never invoked this exception. In every instance, the NPS been able to authorize operators' access while protecting park resources and values. Section 9.30(c) continues the 1978 regulatory statement that application of the regulations are not intended to result in a taking of mineral rights and § 9.104(b)(2) requires that any denial of an operations permit must be consistent with that provision. This change from the 1978 Regulations is not intended or expected to authorize any taking of property rights, and is intended solely to simplify the approval standards and avoid redundancy and confusion. The NPS will continue to work with operators to help plan and design their operations in a way that meets NPS operating standards and other applicable provisions of these regulations.
The Addition Act, 16 U.S.C. 698m-4, directs the NPS to promulgate rules and regulations governing the exploration for and development and production of nonfederal oil and gas interests within the Big Cypress National Preserve and Addition Area.
Accordingly, § 9.105 of this rule describes the procedure for initial review of a proposed operation in Big Cypress National Preserve. This procedure differs slightly from the service-wide procedure described in §§ 9.101 and 9.102. The NPS's service-wide rule incorporates the 30-day initial review period from the Addition Act. However, the Addition Act at 16 U.S.C. 698m-4(b)(2)(C) places a limit on the amount of collaboration that can occur between the NPS and the operator. Under this provision, there is no mechanism for the NPS to require further information from an operator after the NPS has made its initial request for additional information. After making such a request, the NPS's only options are to approve or deny the application. This procedure could conceivably result in denial of applications that would have been approved if the NPS had the regulatory authority to again request the additional information necessary to fully evaluate a proposed operation. In practice, the NPS will continue to collaborate with prospective operators in Big Cypress National Preserve early in their planning process and as much as possible during initial review, in order to reduce such theoretical problems. The NPS is not using the Big Cypress procedure in its service-wide regulations, because it does not want to constrain its ability to have more robust collaboration with operators.
The Addition Act also differs slightly from the proposed service-wide rule in that under the Addition Act the 90-day time period for final action begins upon submission of the permit application to the NPS. For the service-wide rule, the NPS has chosen not to adopt submission of the permit application as the triggering event for final action. Rather, the NPS service-wide rule provides that final action must occur within 30 days after the completion of NPS legal compliance responsibilities (such as NEPA, ESA, and NHPA). For proposals within Big Cypress National Preserve, the NPS will strive to meet the applicable timeframe for final action while otherwise complying with applicable laws including NEPA, ESA, and NHPA.
The NPS has decided it is more appropriate to include these Big Cypress-specific provisions in this regulation instead of in a new park-specific regulation in part 7, because other provisions of this regulation still apply to oil and gas operations in Big Cypress National Preserve. It will be easier for operators to have all applicable provisions in one rule.
Section 9.110 of this rule clarifies the purpose and function of operating
Section 9.110(a) of this rule clarifies the practice under the 1978 Regulations that applicable operating standards will be incorporated into an approved operations permit so that the operating standards become enforceable terms and conditions of an approved permit.
Section 9.110(c) of this rule requires all operators to use technologically feasible, least damaging methods to protect NPS resources and values while assuring human health and safety. In the 1978 Regulations, “technologically feasible, least damaging methods” was part of an overall plan of operations approval standard at 36 CFR 9.37(a)(1).
This rule organizes all operating standards into one section and separates the standards into the following categories: §§ 9.111 through 9.116, are operating standards that apply to all operations; § 9.117, additional operating standards that apply to geophysical operations; and § 9.118, additional operating standards that apply to drilling, stimulation, and production operations. Organizing the standards in this manner will allow the NPS and operators to readily understand which operating standards are applicable to the particular type of operation proposed.
Some of the operating standards in the 1978 Regulations were minimally described. Additional operating standards were included in the NPS's 2006 9B Operator's Handbook. This rule now contains all operating standards. To the extent this rule incorporates operating standards from the 1978 Regulations without substantive change; those standards are not further discussed below. The operating standards summarized below are either clarifications to the 1978 Regulations, are new standards that the NPS has added, or are revisions to those included in the proposed rule.
This rule modifies language from § 9.112(a) of the proposed rule to remove the phrase “ground disturbing” because no activities incident to oil and gas operations, whether or not they disturb the ground, may be conducted within 500 feet of any structure or facility used by the NPS for interpretation, public recreation, or administration. The NPS moved § 9.112(a) of the proposed rule to § 9.111(a) of this rule. Section 9.111(a) of this rule modifies language from § 9.112(a) of the proposed rule to clarify that Superintendents may increase or decrease the 500 foot setback consistent with the need to protect federally owned or administered lands, water, or resources of System units, visitor uses or experiences, or visitor or employee health and safety. The NPS also added the phrase “within 500 feet of the mean high tide line” to § 9.111(a) of this rule to provide notice to operators that the general 500 foot setback also applies to tidal areas.
This rule includes a new standard at § 9.111(b) to require that either existing or newly created surface disturbance is kept to the minimum necessary for safe conduct of operations.
This rule modifies language from § 9.111(d) of the proposed rule to clarify how waste must be handled.
This rule modifies language from § 9.111(g) of the proposed rule to clarify that hydrocarbon and air pollutant releases are to be minimized along with minimizing the flaring of gas.
This rule adds new standards at §§ 9.114 and 9.115 that limit the visual and sound impacts of oil and gas operations on park visitor use and experience.
This rule adds a new standard at § 9.111(h) that requires operators to control the introduction of exotic species.
This rule adds new standards at § 9.112 that address hydrologic connectivity.
Section 9.116 of this rule describes the standards for reclamation.
Section 9.117 of this rule describes standards for geophysical surveying methods including source points, use of equipment and methods, and shot holes.
Section 9.118(a)(1) of this rule requires all operators to use containerized mud systems during drilling, stimulation, and production operations.
Section 9.118(a)(2) of this rule prohibits the establishment of new earthen pits for any use. Use of existing earthen pits may continue, however, the Superintendent may require the pits be lined or removed depending on site specific conditions.
Section 9.118(b) of this rule establishes standards for well stimulation, including standards that address hydraulic fracturing operations, such as ensuring the mechanical integrity of the wellbore, water use and disposal, and management of flowback fluids.
NPS's approach is to review an operator's submissions to determine if they meet the overall operating standard of using the most “technologically feasible, least damaging methods” that protect park resources and values, and any other applicable operation standards. If not, the NPS will add terms and conditions in the permits to address specific deficiencies. In light of our previous experience under the 1978 Regulations addressing downhole operations, we expect that application of these requirements will result in little or no change to well stimulation activities proposed by an operator and approved by the state. We also expect that in most cases the information needed to be reviewed by NPS will be that already submitted to the state for its approval. Guidance on specific means to meet NPS operating standards is found in NPS's 2006 9B Operator's Handbook, which is distributed to every operator and available electronically.
This rule contains a new “General Terms and Conditions” section listing terms and conditions that apply to all operations. This section consolidates the following sections from the 1978 Regulations: §§ 9.35, 9.36(a)(15), 9.37(f), 9.41(g), 9.42, 9.46, 9.47(b), and 9.51(a) and (b). Described below are either clarifications to the 1978 Regulations, new terms and conditions that the NPS has added, or revisions to those included in the proposed rule.
The water use section at § 9.35 of the 1978 Regulations did not address all state water law systems under which water rights are established or decided. Section 9.120(b) of this rule requires that an operator may not use any surface water or groundwater owned or administered by the United States that has been diverted or withdrawn from a source located within the boundaries of a System unit unless the use has been approved in accordance with NPS policy.
Because monitoring and reporting requirements are necessary for all operations, the NPS includes monitoring and reporting requirements under General Terms and Conditions.
The NPS has modified language from § 9.121(c) and (d) of the proposed rule to clarify the timing for reporting of incidents occurring on an operations site and for reporting requirements for cultural or scientific resources encountered on an operations site, respectively.
Section 9.121(e) broadens the reporting requirement from the 1978 Regulations to require that the operator submit any information requested by the Superintendent that is necessary to verify compliance with either a provision of the operations permit or this subpart. To ease this burden, the rule allows an operator to submit the same reports it submits to a state or other federal agency as long as those reports meet the information requirements of this subsection. This is similar to § 9.42 of the 1978 Regulations.
Section 9.122 requires reporting related to the hydraulic fracturing process, including the disclosure of chemicals used in the hydraulic fracturing process and the volume of recovered fluids. In § 9.122, NPS has used BLM's post-hydraulic fracturing reporting requirements, but did not include two provisions (requirement for affidavit of compliance and general supporting documentation), as those requirements are addressed in other sections of this rule.
This rule contains a new section that addresses access across federally owned or administered lands or waters to reach the boundary of an operator's oil and gas right. Section 9.50 of the 1978 Regulations authorized the NPS to charge a fee for commercial vehicles using NPS administered roads. Despite this longstanding authority, we are not aware that such fees had actually been collected. This new section expands upon former § 9.50.
Section 9.131(a)(1) of this rule allows the NPS to charge an operator a fee based on fair market value for access (
The NPS renamed this section of the rule “Financial Assurance” (titled “Performance Bond” under the 1978 Regulations) to better reflect the variety of instruments that operators can provide to the NPS to meet their obligation under this section.
Section 9.48(a) of the 1978 Regulations required an operator to file a performance bond, or other acceptable method of financial assurance, for all types of non-federal oil and gas operations and all phases of the operations. The performance bond requirement ensured that in the event an operator becomes insolvent or defaults on its obligations under an approved plan of operations, the defaulted funds would be paid to the United States.
Section 9.48(d)(3) of the 1978 Regulations limited the performance bond amount to $200,000 per operator, per System unit. Therefore, if one operator had multiple wells in an System unit, the NPS could only require up to $200,000 financial assurance from that operator. The $200,000 limit was established in 1979 and in most cases did not reflect the potential costs of reclamation. In the event of a default by the operator, reclamation costs exceeding the limit could have required the NPS to bring a civil action in federal court to recover the additional costs.
Section 9.140 of this rule requires the operator to file with the NPS financial assurance in a form acceptable to the Regional Director. The current 9B Operator's Handbook identifies acceptable forms of financial assurance as including: corporate surety bonds, US Treasury bonds, irrevocable letters of credit, cash. The NPS will update the Handbook as additional guidance is provided.
Section 9.141 of this rule makes the financial assurance amount equal to the estimated cost of reclamation. This substantially reduces the risk of the American taxpayers being left to assume reclamation costs in the event of operator default.
Section 9.142 of this rule outlines the process for adjusting the amount of financial assurance due to changed conditions. Section 9.143 describes the conditions under which the NPS will release the financial assurance. Section 9.144 describes those circumstances that will result in forfeiture.
Section 9.144(b)(3) of this rule allows the NPS to suspend review of an operator's pending permit applications, if that operator has forfeited its financial assurance in any System unit. Suspension would last until the Superintendent determines that all violations have been resolved.
Section 9.150 of this rule renames the “Supplementation or Revision of Plan of Operations” section as “Modification to an Operation” to characterize any change to an approved operations permit. This section clarifies that either the NPS or the operator can request modification of the operator's permit, and describes the modification procedures. Approval of any modification to an approved permit must meet the relevant criteria applicable to Temporary Access Permits (§§ 9.60 through 9.63) or Operations
Section 9.150(c) of this rule prohibits an operator from implementing a modification until the NPS has provided written approval of the modification. No comments were received on this provision of the proposed rule.
This section renames § 9.34 “Transfer of Interest” of the 1978 Regulations to “Change of Operator.”
Section 9.34(a) of the 1978 Regulations provided that a previous operator remained liable on its financial assurance until it informed the NPS that the rights had been transferred to another party. A new operator could not operate until it posted financial assurance and ratified the existing plan of operations. Once the previous operator provided notice to the Superintendent, the previous owner could request release of its financial assurance before the new owner posted its own financial assurance with the NPS. Therefore, if the new operator abandoned operations before posting financial assurance with the NPS, the burden of reclaiming the site would fall on the taxpayers.
Section 9.160(a) requires the previous operator to notify the NPS of a transfer of operations and provide contact information. Section 9.160(b) holds the previous operator responsible to the NPS until the new operator adopts and agrees to the terms and conditions of the previous operator's permit; and provides financial assurance; provides proof of liability insurance; and an affidavit demonstrating compliance with applicable federal, state, or local laws. Section 9.160(c) addresses a transfer of operation where the previous operator did not have an operations permit.
Section 9.161(a) of this rule requires the new operator who acquires an operation that was under an operations permit to adopt the previous permit. Section 9.161(b) addresses the transfer of an operation where an exemption has been granted under § 9.72 of this rule. Section 9.161(c) addresses transfer of an operation where the previous operator did not have an operations permit. No comments were received on this provision of the proposed rule.
This section replaces, in part, § 9.39(a)(2)(iv) of the 1978 Regulations and creates a new section entitled “Well Plugging.”
Section 9.39(a)(2)(iv) of the 1978 Regulations required operators to plug and cap all non-productive wells and to fill dump holes, ditches, reserve pits, and other excavations. Section 9.116(d)(1) (Operating Standards) retains the requirement that an operator conduct reclamation by plugging all wells. However, the 1978 Regulations did not directly address whether NPS could require an operator to plug wells that have been in an extended shut-in status. As a result, inactive wells have remained unplugged for years and, in some instances, decades. Such unplugged wells have caused adverse impacts to park resources and presented risks to park visitors.
Section 9.170(a) of this rule requires operators to plug a well within 60 days after cessation of drilling, or 1 year after completion of production operations, or upon the expiration of NPS approved shut-in status. Under § 9.171, an operator may obtain an extension to the plugging requirement if the operator demonstrates mechanical integrity, a plan for future use of the well, and that the operator will follow maintenance requirements.
These procedures are consistent with the way many states approach the issue of inactive wells, and recognize that certain economical or logistical reasons exist to justify maintenance of wells in shut-in status for extended periods of time. Rather than a “produce or plug” policy, the rule is intended to ensure that shut-in wells are maintained in an environmentally sound and safe manner.
Section 9.51(c) of the 1978 Regulations provided two different compliance procedures for suspending an operation, depending on whether or not the violation posed an “immediate threat of significant injury to federally owned lands or waters.”
Section 9.181 of this rule authorizes the Superintendent to suspend an operation regardless of whether an operator's violation poses an “immediate threat of significant injury.” Whether the threat is immediate or not, any violation that results in a threat of damage to park resources and values should be addressed by the Superintendent.
Section 9.180 lists prohibited acts to provide operators with notice of the acts that constitute a violation of these regulations. The prohibited acts in this rule include violations of the terms and conditions of an Operations Permit, as well as violations of other provisions of these regulations.
Section 9.51 of the 1978 Regulation authorized the NPS to suspend an operation for non-compliance, and if the violation or damage was not corrected, revoke an operator's plan of operations. The process to suspend an operation required coordination between park staff and other NPS offices, during which time damage to park system resources and values may continue. Additionally, suspension and revocation were not necessarily the most appropriate means to correct minor acts of non-compliance (minor leaks and spills, improper road maintenance, or not maintaining proper site security). Therefore, we are incorporating our existing penalties provision at 36 CFR 1.3, which allows NPS law enforcement rangers and special agents to issue citations, which result in fines for minor acts of non-compliance, while treating serious acts as ones that may be subject to a fine or imprisonment, or both.
Under § 9.182 of this rule, NPS will not review any new operating permit applications or continue review of any pending permit applications in any System unit until an operator comes into compliance with this subpart or the terms or conditions of an operations permit. No comments were received on this provision of the proposed rule.
Most of the procedures outlined in § 9.49 of the 1978 Regulations remain the same. The operator continues to have the right to appeal a decision made by either the Superintendent or the Regional Director. The operator now must exhaust these remedies before the NPS decision is a final agency action that is subject to review under the Administrative Procedure Act (APA).
This rule renames the first step of the process as a request for “reconsideration,” rather than an appeal, since it is directed to the same official who issued the original decision. The rule also includes other clarifications of the existing language, makes editorial corrections, and reorganizes the sequence of some of the paragraphs.
Consistent with the APA, § 9.193(a) of this rule provides that during the reconsideration and appeals process the NPS's decision will be suspended and the decision will not become effective until the completion of the appeals process. Section 9.193(b) addresses suspension of operations due to
Under section 9.194, if the Superintendent has the authority to make the original decision, requests for reconsideration and appeals are to be filed in the manner provided under §§ 9.190 through 9.193, except that requests for reconsideration are directed to the Superintendent, and appeals are directed to the Regional Director.
No comments were received on these provisions of the proposed rule.
The rule renames the “Public Inspection of Documents” section to “Public Participation.” Section 9.52(a) of the 1978 Regulation required a Superintendent to publish a notice in a local newspaper of a request to conduct non-federal oil and gas operations whether or not a complete plan of operations was ever submitted by an operator. Section 9.52(b) of the 1978 Regulation further required a Superintendent to publish a notice in the
The rule retains the ability for an operator to protect proprietary or confidential information from disclosure to the public. Operators need to clearly mark those documents that they wish to protect from public disclosure as “proprietary or confidential information” such that these documents are readily identifiable by the NPS decision maker. The NPS has also included provisions that allow an operator engaged in hydraulic fracturing operations to withhold chemical formulations that are deemed to be a trade secret. The NPS has updated § 9.200(c) from the proposed rule to include reference to §§ 9.88 and 9.89 to allow operators to maintain proprietary information for stimulation techniques. The NPS has also removed language from § 9.200(g) of the proposed rule regarding record retention for operations on Indian and Federal lands to make this provision conform to the scope of this regulation.
See Paperwork Reduction Act discussion below.
A summary of substantive comments and NPS responses is provided below followed by a table that sets out changes we have made in the final rule based on the analysis of the comments and other considerations.
1.
2.
Although the NPS does not generally assert regulatory authority over activities on non-federal lands,
This rule applies to all operations conducted within the boundary of a System unit, with the exception of System units in the State of Alaska, where this rule does not apply. As explained in the preamble to the proposed rule: “ [NPS's] experience over the past three decades has demonstrated that [operations conducted on non-federal lands] have the potential to have adverse effects on NPS resources, values, and visitor health and safety. Through site inspections, the NPS has found at least 10 instances of sites [on non-federal lands] with oil spills or leaks resulting in contamination of soils and water.” (80 FR 65575). That an operation is located on non-federal lands within a System unit does not mean that the operation has no potential to affect NPS administered resources and values.
3.
4.
Congress mandated that System units be managed “for the benefit and inspiration of all the people of the United States.” In the context of these regulations, the NPS fulfills its mandate by applying a consistent set of Servicewide standards to govern oil and gas activities in all System units. These regulations are designed to protect the unique and nationally significant natural and cultural resources that constitute each System unit, including: Geological resources, air quality, water quality and quantity, vegetation, fish and wildlife and their habitat, floodplains and wetlands, archeological resources, paleontological resources, soundscapes, night skies, viewsheds, cultural landscapes, and ethnographic resources. These regulations are also
5.
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NPS will continue to determine, on a case by case basis and in collaboration with prospective operators, whether a proposed operation meets the operating standards and approval standards of these regulations. If the proposed operation does not meet 9B approval standards, the NPS has the authority to seek to acquire the mineral right from the operator.
10.
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Regulatory authority over directional drilling operations begins at the subsurface point where the proposed operation (borehole) crosses the park boundary and enters federally owned or administered lands or water, and applies to all infrastructure and activities within the System unit. Section 9.70 of this rule states that “downhole activities inside an NPS unit are subject to these regulations.”
The NPS does not require financial assurance from directional drilling operators because, although the operation is drilling to a bottom hole location within the System unit, the surface operation is located outside the park boundary on lands not administered by the NPS. Each state has requirements for plugging, abandonment, surface reclamation, and financial assurance from the operator.
The NPS examines each exemption application to ensure that the downhole portion of the operation that is inside the park boundary meets the NPS approval standard. If the NPS finds, through monitoring of the operation, that the operation inside the park is causing damage to park administered resources or values, the NPS may require the operator to rectify the violation. The NPS has additional guidance describing the process for applying for such an exemption in the 9B Operator's Handbook.
20.
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Providing for automatic approval of a permit application if the NPS does not meet a deadline would most likely violate procedural and substantive legal requirements for agency actions.
30.
Section 9.103(a)(1) of this rule has been updated from the proposed rule to reflect that the Regional Director must determine that the operations will not impair park resources and values under the NPS Organic Act, or violate other statutes governing administration of specific units of the National Park System. Enabling statutes are mentioned because NPS is required to comply with requirements imposed by Congress for individual System units.
31.
32.
The NPS has removed the phrase “ground disturbing” from this rule because generally no activities incident to oil and gas operations, whether or not they disturb the ground, may be conducted within 500 feet of any structure or facility used by the NPS for interpretation, public recreation, or administration. We have clarified the language in this rule regarding the Superintendent's discretion to increase or decrease this distance consistent with the need to protect federally owned or administered lands, waters, or resources of System units, visitor uses or experiences, or visitor or employee health and safety.
33.
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Section 9.52(b) of the 1978 Regulations required the Superintendent to publish a notice in the
49.
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After taking the public comments into consideration and after additional review, the NPS made the following substantive changes in the final rule as described in the table below. The NPS also made numerous non-substantive changes to the regulatory language and formatting in the final rule. These non-substantive changes are not included in the table below.
Executive Order 12866 provides that the Office of Information and Regulatory Affairs in the Office of Management and Budget will review all significant rules. The Office of Information and Regulatory Affairs has determined that this rule is significant because it may raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive order.
Executive Order 13563 reaffirms the principles of Executive Order 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. Executive Order 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements.
This rule does not have a significant economic effect on a substantial number of small entities under the RFA (5 U.S.C. 601
This rule is not a major rule under 5 U.S.C. 804(2) of the SBREFA. This rule:
(a) Does not have an annual effect on the economy of $100 million or more;
(b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, state, or local government agencies, or geographic regions; and
(c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.
These conclusions are based upon the cost-benefit and regulatory flexibility analysis found in the report entitled Cost-Benefit and Regulatory Flexibility Analyses: U. S. Department of the Interior, National Park Service for Proposed Revisions to 36 CFR part 9, subpart B, which can be viewed at
This rule does not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local, or tribal governments or the private sector. It addresses use of national park lands, and imposes no requirements on other agencies or governments. A statement containing the information required by the UMRA (2 U.S.C. 1531
The NPS received public comment that additional regulation of private oil and gas rights on NPS land could infringe on private property rights or could represent a taking. The rule does not take private property or authorize the taking of private property. Moreover, implementation of the rule is not likely to result in a taking of private property.
The rule updates regulations that have been in effect since 1979. It updates various provisions of the existing regulations in a manner that is consistent with current industry standards and technological capabilities, prevailing industry and investor expectations, and the most recent developments in regulatory and takings law. It authorizes NPS to recover its legitimate permit-processing and monitoring costs and to charge operators for privileged access across federal lands (
The rule extends the applicability of these regulations to most currently exempt operations located within park boundaries. During the 36 years that the existing regulations have been in place, however, NPS has never disapproved a submitted plan of operations and no mineral owner or operator has ever filed a claim asserting that implementation of the regulations has resulted in a taking of private property. Moreover, as described above, the rule updates the existing regulations in a manner consistent with current industry standards and technological capabilities. Accordingly, the application of the rule to currently exempt operations is not likely to result in a taking. The rule continues to allow operators reasonable access across federally owned surface to develop non-federal mineral rights. No other private property is affected. The rule brings outdated provisions into line with modern regulatory practice and is a reasonable exercise of its regulatory authority.
Finally, the regulatory text will continue to state (as do the existing regulations) that it is not intended to result in a taking. The existing regulations also contain a second provision that expressly applies the lower of the two standards of review in the event of a possible taking. Because this rule contains only one standard of review (in an effort to simplify the rule), such a provision no longer appears appropriate. NPS has never actually needed to invoke that second provision, nor has it ever failed to provide final approval for a plan of operations that has been sought. Under the rule, NPS retains discretion to make individual permit decisions that will avoid a taking if an unexpected problem should arise.
Under the criteria in section 1 of Executive Order 13132, the rule does not have sufficient federalism implications to warrant the preparation of a Federalism summary impact statement. It addresses use of national park lands, and imposes no requirements on other agencies or governments. A Federalism summary impact statement is not required.
This rule complies with the requirements of Executive Order 12988. Specifically, this rule:
(a) Meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and
(b) Meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.
The Department of the Interior strives to strengthen its government-to-government relationship with Indian Tribes through a commitment to consultation with Indian Tribes and recognition of their right to self-governance and tribal sovereignty. We evaluated this rule under the Department's consultation policy and under the criteria in Executive Order 13175 and determined that it has no substantial direct effects on federally recognized Indian tribes and that consultation under the Department's tribal consultation policy is not required. Nonetheless, NPS consulted with all federal tribes traditionally associated with System units that have current oil and gas operations, and System units that do not have active operations, but have potential for future operations. The NPS initially consulted with federal tribes during scoping for the DEIS. Upon initial consultation, the NPS received letters back from the Choctaw Nation of Oklahoma, the Hopi Tribe, the Navajo Nation, and the San Carlos Apache Tribe of the San Carlos Reservation requesting consultation and review of the DEIS, once available. The NPS again consulted with all federal tribes traditionally associated with System units that have current oil and gas operations, and System units that do not have active operations, but have potential for future operations when the DEIS and proposed rule were released for the 60 day public comment period. The NPS received letters/emails back from the Choctaw Nation of Oklahoma, Pueblo of Santa Ana and Pueblo of Santa Clara on its second consultations letters. These letters are available in the appendix to the FEIS. In recognition of its relationship with tribal affiliates, the NPS Alaska Regional office reached out directly to Alaska tribes. NPS received no follow up comments from the Alaska tribal affiliates.
This rule contains information collection requirements that have been approved by the Office of Management and Budget (OMB) under the PRA (44 U.S.C. 3501
Currently, there are oil and gas operations in 12 of the 410 parks in the National Park System, and about 60 percent of those operations are exempt from NPS regulations. This rule would apply NPS regulations to operations that are currently exempt and any future oil and gas operations in the National Park System. We will use the information collected to: (1) Evaluate proposed operations, (2) ensure that all necessary mitigation measures are employed to protect park resources and values, and (3) ensure compliance with all applicable laws and regulations. We will collect information associated with non-Federal oil and gas operations within units of the National Park System under the below listed sections of 36 CFR part 9, subpart B:
During the proposed rule stage, we received one comment which addressed the issue of the information requested under this rule. The commenter suggested that the NPS collect baseline and historical data on groundwater levels, water quality, aquifer conditions, groundwater discharge, natural features, and aquatic and wildlife habitats that could be used to evaluate potential effects and actual impacts of mineral development on habitats, communities,
The public may comment, at any time, on the accuracy of the information collection burden in this rule and may submit any comments to the Information Collection Clearance Officer, National Park Service, 12201 Sunrise Valley Drive (Mail Stop 242), Reston, VA 20192.
This rule constitutes a major Federal action with the potential to significantly affect the quality of the human environment. We have prepared the FEIS under the requirements of NEPA. On October 20, 2016, the Director of the National Park Service signed the Record of Decision identifying Alternative B in the FEIS as the selected action. The FEIS and ROD are available online at
This rule is not a significant energy action under the definition in Executive Order 13211. A statement of Energy Effects is not required.
This rule reflects the collective efforts of NPS staff in the Geologic Resources Division, parks, and field offices, with assistance from the Regulations, Jurisdiction, and Special Park Uses Division.
National parks, Penalties, Reporting and recordkeeping requirements
National parks, Oil and gas exploration, Reporting and recordkeeping requirements.
In consideration of the foregoing, the National Park Service amends 36 CFR parts 1 and 9 as follows:
54 U.S.C. 100101, 100751, 320102.
(a) A person convicted of violating a provision of the regulations contained in parts 1 through 7, part 9 subpart B, and parts 12 and 13 of this chapter, within a park area not covered in paragraph (b) or (c) of this section, shall be punished by a fine as provided by law, or by imprisonment not exceeding 6 months, or both, and shall be adjudged to pay all costs of the proceedings.
(b) A person who knowingly and willfully violates any provision of the regulations contained in parts 1 through 5, 7, part 9 subpart B, and part 12 of this chapter, within any national military park, battlefield site, national monument, or miscellaneous memorial transferred to the jurisdiction of the Secretary of the Interior from that of the Secretary of War by Executive Order No. 6166, June 10, 1933, and enumerated in Executive Order No. 6228, July 28, 1933, shall be punished by a fine as provided by law, or by imprisonment for not more than 3 months, or by both.
These park areas are enumerated in a note under 5 U.S.C. 901.
(c) A person convicted of violating any provision of the regulations contained in parts 1 through 7 and part 9 subpart B of this chapter, within a park area established pursuant to the Act of August 21, 1935, 49 Stat. 666, shall be punished by a fine as provided by law and shall be adjudged to pay all costs of the proceedings. 54 U.S.C. 320105.
(d) Notwithstanding the provisions of paragraphs (a), (b), and (c) of this section, a person convicted of violating § 2.23 of this chapter shall be punished by a fine as provided by law. 16 U.S.C. 6811.
16 U.S.C. 410hh; 16 U.S.C. 3101,
16 U.S.C. 230a(a)(4), 459d-3, 460cc-2(i), 460ee(c)(4), 698c(b)(2), 698i(b)(2), and 698m-4; 18 U.S.C. 3571 and 3581; 31 U.S.C. 9701; 54 U.S.C. 100101, 100751, and 103104.
(a) The purpose of this subpart is to ensure that operators exercising non-federal oil and gas rights within a System unit outside of Alaska use technologically feasible, least damaging methods to:
(1) Protect federally owned or administered lands, waters, or resources of System units;
(2) Protect NPS visitor uses or experiences, or visitor or employee health and safety; and
(3) Protect park resources and values under the statute commonly known as the NPS Organic Act;
(b) This subpart applies to all operators conducting non-federal oil or gas operations on lands or waters within System units outside of Alaska, regardless of the ownership or legislative jurisdiction status of those lands or waters.
(c) We do not intend for this subpart to result in a taking of a property interest. Application of this subpart is intended to reasonably regulate operations within System units that may affect federally owned or administered lands, waters, and resources, visitor uses and experiences, and visitor and employee health and safety.
(a) This subpart applies to you if you are an operator who conducts or proposes to conduct non-federal oil or gas operations outside of Alaska.
(b) If you were operating outside of a System unit and your operation has been included within an existing System unit as a result of a change to the boundary, or included within a newly established System unit, you are subject to §§ 9.50 through 9.53.
(c) If you were operating under an exemption because your operation accessed oil and gas rights inside the System unit boundary from a surface location outside the boundary, and your surface location has been included within an existing System unit as a result of a change to the boundary, or included within a newly established System unit, you are subject to §§ 9.50 through 9.53.
(a) Except as provided in §§ 9.70 through 9.73, you must obtain a temporary access permit under §§ 9.60 through 9.63 or an operations permit under §§ 9.80 through 9.90 before conducting operations.
(b) You must demonstrate that you have the right to operate in order to conduct activities within a System unit.
(a) If you already have an NPS-approved plan of operations, you may continue to operate according to the terms and conditions of that approval, subject to the provisions of this subpart. For purposes of this subpart, we consider your approved plan of operations to be either a temporary access permit or operations permit.
(b) This section applies to you if we have granted you an exemption to the plan of operations requirement because your operation accesses oil and gas rights inside a System unit boundary from a surface location outside the boundary. You may continue to operate under the exemption provided that your operations comply with the general terms and conditions of §§ 9.120 through 9.122. You are also subject to
In addition to the definitions in 36 CFR 1.4, the following definitions apply to this subpart:
(1) Operations include, but are not limited to: Access by any means to or from an area of operations; construction; geological and geophysical exploration; drilling, well servicing, workover, or recompletion; production; gathering (including installation and maintenance of flowlines and gathering lines); storage, transport, or processing of petroleum products; earth moving; excavation; hauling; disposal; surveillance, inspection, monitoring, or maintenance of wells, facilities, and equipment; reclamation; road and pad building or improvement; shot hole and well plugging and abandonment, and reclamation; and all other activities incident to any of the foregoing.
(2) Operations do not include reconnaissance surveys as defined in this subpart or oil and gas pipelines that are located within the System unit under authority of a deeded or other right-of-way.
(1) A reconnaissance survey includes identification of the area of operations and collection of natural and cultural resource information within and adjacent to the proposed area of operations.
(2) Except for the minimal surface disturbance necessary to perform cultural resource surveys, natural resource surveys, and location surveys required under this subpart, surface disturbance activities are beyond the scope of a reconnaissance survey.
(1)(i) Supplies any public water system; or
(ii) Contains a sufficient quantity of ground water to supply a public water system and either:
(A) Currently supplies drinking water for human consumption; or
(B) Contains fewer than 10,000 mg/l total dissolved solids; and
(2) Is not an exempted aquifer under state law.
Yes. You must obtain an NPS operations permit.
Within 90 days after December 5, 2016 or within 90 days after the effective date of a boundary change, or establishment of a new System unit, as applicable, you must submit the following to the Superintendent of the System unit in which you propose to continue to conduct operations:
(a) The names and contact information of the operator, the owner, and the individuals responsible for overall management, field supervision, and emergency response of the proposed operations;
(b) Documentation demonstrating that you hold a right, and the extent of such right, to operate within the System unit;
(c) A brief description of the current operations and any anticipated changes to the current operations;
(d) The American Petroleum Institute (API) well number or State well-identification permit number;
(e) Maps to scale that clearly delineate your current area of operations as of
(f) The results of any reconnaissance surveys you have conducted to be used by the Superintendent to identify resource protection measures in your operations permit.
(g) A spill control and emergency preparedness plan as required by § 9.86;
(h) Documentation of the current operating methods, surface equipment, downhole well construction and completion, materials produced or used, and monitoring methods;
(i) A description of how your proposed operation will meet each applicable operating standard at §§ 9.110 through 9.116 and 9.118; and
(j) A description of the procedures to be used and cost estimates for well plugging and surface reclamation.
The NPS will review your application and take action under §§ 9.100 through 9.104.
During this interim period, you may continue to conduct operations subject to the following conditions:
(a) Continuation of operations is limited to those methods and the area of disturbance that existed on December 5, 2016 or the effective date of a boundary change, or establishment of a new System unit, as applicable.
(b) Your operation is subject to the general terms and conditions in §§ 9.120 through 9.122 and the prohibitions and penalties in §§ 9.180 through 9.182.
(c) Except in an emergency, we will not take any steps to directly regulate your operation before 90 days after December 5, 2016 or 90 days after the effective date of a boundary change, or establishment of a new System unit, as applicable.
(a) You must apply to the Regional Director for a temporary access permit to access your proposed area of operations that is on NPS administered lands or waters in order to conduct reconnaissance surveys. This permit will describe the means, routes, timing, and other terms and conditions of your access as determined by the Regional Director.
(b) A temporary access permit is subject to cost recovery under 54 U.S.C. 103104.
To apply for a temporary access permit, you must submit the following information to the Superintendent of the System unit in which you propose to conduct operations:
(a) Documentation demonstrating that you hold a right, and the extent of such right, to operate within the System unit;
(b) A map delineating the proposed reconnaissance survey areas in relation to the System unit boundary and the proposed area of operations at a minimum scale of 1:24,000, or a scale specified by the Superintendent as acceptable;
(c) A brief description of the intended operation so that we can determine the scope of the reconnaissance surveys needed;
(d) The name and contact information of the operator, employee, agent, or contractor responsible for overall management of the proposed reconnaissance surveys;
(e) The name, legal address, telephone number, and qualifications of all specialists responsible for conducting the reconnaissance surveys;
(f) A description of proposed means of access and routes proposed for conducting the reconnaissance surveys; and
(g) A description of the survey methods you intend to use to identify the natural and cultural resources.
If the Regional Director determines that your proposed reconnaissance surveys will not result in surface disturbance, except for minimal disturbance necessary to perform required surveys, the Regional Director will issue you a temporary access permit within 30 days after receipt of a complete application, unless the Regional Director notifies you that additional time is necessary to evaluate or process your application.
The duration of your temporary access permit will be stated in the permit, based upon the scope of the reconnaissance surveys needed. The Regional Director may, upon written request, extend the term of the temporary access permit.
Your downhole operations inside a System unit are subject to these regulations. If you wish to access your oil and gas rights located inside a System unit from a surface location outside the unit, you must submit the information required by § 9.71. We will evaluate this information and may request that you apply for an operations permit. We will require an operations permit for such operations only if we determine that downhole permit requirements are needed to protect against a significant threat of damage to:
(a) Federally owned or administered lands, waters, or resources within System units;
(b) NPS visitor uses or experiences; or
(c) Visitor or employee health or safety.
You must provide the information required by this section to the Superintendent of the System unit. You must provide all of the following.
(a) The names and contact information of:
(1) The operator;
(2) The owner; and
(3) The individuals responsible for overall management, field supervision, and emergency response of the proposed operations.
(b) Documentation demonstrating that you hold a right, and the extent of such right, to operate within the System unit.
(c) Maps and plats to scale showing the boundaries of each of the oil or gas rights that are relevant to your proposed operations within the System unit boundary.
(d) Maps and plats to scale showing all proposed surface uses (well site, access route, flowlines, production facilities) that occur outside the System unit.
(e) Information regarding downhole operations and conditions, including:
(1) Description, including depths, thicknesses, and properties of geologic horizons between the target zone and the base of the deepest aquifer;
(2) Drilling plan, including directional-drilling program, horizontal distance along the wellbore's path from well's surface location to the System unit boundary, depth at which wellbore crosses the boundary, and timeline for operations;
(3) Casing, cementing, and mud programs;
(4) Stimulation programs; and
(5) Well plugging and abandonment program.
(f) If you propose hydraulic fracturing, then you must also provide the information required by § 9.89.
(a) Within 30 days after receiving your submission under § 9.71, the Superintendent will notify you in writing that your information is complete, you need to submit more information, or we need more time to review your submission.
(b) After NPS receives your complete submission, and completes compliance with applicable federal laws, including the National Environmental Policy Act, the Superintendent will notify you in writing within 30 days that either:
(1) No further action is required by the NPS and you are exempt from the operations permit requirement; or
(2) You must obtain an operations permit.
(c) If you need an operations permit, the information provided under § 9.71 is your permit application and the NPS will review your application under §§ 9.100 through 9.104.
If the NPS notifies you under § 9.72 that you do not need an operations permit, your operations are still subject to the general terms and conditions in §§ 9.120 through 9.122, the prohibitions and penalties in §§ 9.180 through 9.182, and the requirements in this section.
(a) You must notify the NPS within 30 days if the methods or the environmental conditions of your downhole operations materially change.
(b) The Regional Director may notify you in writing that you are no longer exempt from the operations permit requirement after determining that downhole operational requirements are needed to protect against a significant threat of damage to any of the following:
(1) Federally owned or administered lands, waters, or resources of System units;
(2) NPS visitor uses or experiences; or
(3) Visitor or employee health or safety.
(c) Within 30 days after receiving this notification, you must file your operations permit application with the Superintendent.
(a) Except as otherwise provided in §§ 9.70 through 9.73, an operator proposing to conduct operations within the boundary of a System unit must submit an application for an operations permit to the Superintendent.
(b) An operations permit is subject to cost recovery under 54 U.S.C. 103104.
(a) In satisfying the requirements of §§ 9.82 through 9.90, you do not need to resubmit information that is already on file with the NPS. Instead, you may reference the previously submitted information in your permit application.
(b) You may submit documents and materials containing the information required by §§ 9.82 through 9.90 that you submit to other Federal and State agencies. If you do this, you must clearly identify the information required by §§ 9.82 through 9.90.
(a) Your application for an operations permit must include all of the information required by § 9.83 and, to the extent applicable, the information required by §§ 9.87 through 9.90, as well as any additional information that the Superintendent may require by written request.
(b) You may provide information for only the phase of operations you propose. Each permit application is only required to describe those activities for which you request approval. Approval of an operations permit covering one phase of operations does not assure future approval of, or the terms of future approval for, an operations permit covering a subsequent phase.
All applications must include the information required by this section.
(a) You must submit to-scale maps that clearly depict:
(1) The boundaries of your oil or gas rights in relation to your proposed operations and the relevant System unit boundary;
(2) The natural features, including, but not limited, to streams, lakes, ponds, wetlands, seepage areas, springs, shallow water aquifers, topographic relief, and areas we have indicated to you as environmentally sensitive;
(3) The locations of existing roads, trails, railroad tracks, pads, and other disturbed areas; and
(4) The locations of existing structures that your operations could affect, including but not limited to: Buildings, pipelines, existing or permitted oil or gas wells, freshwater wells, underground and overhead electrical lines, and other utility lines.
(b) You must submit the following information about geologic conditions in their natural state and under the proposed operating conditions:
(1) Estimated depths and names of known zones of usable water, brine, hydrocarbon, geothermal, or other mineral-bearing zones based on the best available information;
(2) Potential hazards to persons and the environment such as known abnormal pressure zones, lost circulation zones, hydrogen sulfide gas, or karst formations; and
(3) Nature, extent, and depth (if known) of near-surface bedrock fracturing or jointing relative to proposed cemented surface casing-seat depth and any open annular interval proposed in the well design.
(c) You must submit the following information for any new surface disturbances or construction:
(1) Maps depicting the proposed area of operations, boundaries of new surface disturbances and proposed access routes;
(2) Maps depicting the proposed location of all support facilities, including those for transportation (
(3) The methods and diagrams, including cross-sections, of any proposed pad construction, road construction, cut-and-fill areas, and surface maintenance, including erosion control;
(4) The number and types of equipment and vehicles, including an estimate of vehicular trips, associated with each phase of your operation;
(5) An estimated time to complete each phase of the proposed operations, including any operational timing constraints;
(6) The type and extent of security measures proposed within your area of operations;
(7) The power sources and their transmission systems for the proposed operations; and
(8) The types and quantities of all solid and liquid waste generation and the proposed methods of storage, handling, and off-site disposal.
You must submit the following information about environmental conditions and mitigation actions:
(a) Description of the natural and cultural resource conditions from your reconnaissance surveys or other sources collected for your proposed area of operations. The Superintendent may require, on a case by case basis, baseline field testing of soils and field or laboratory testing of surface, or near-surface, waters within your area of operations, as well as any groundwater resources that may reasonably may be impacted by your surface operations;
(b) Description of the steps you propose to take to mitigate any adverse environmental impacts on park resources and values, including but not limited to, the System unit's land features, land uses, fish and wildlife, vegetation, soils, surface and subsurface water resources, air quality, noise, lightscapes, viewsheds, cultural resources, and economic environment; and
(c) Discussion of:
(1) Any anticipated impacts that you cannot mitigate; and
(2) All alternative technologically feasible, least damaging methods of operations, their costs, and their environmental effects.
You must submit the following information about your spill control and emergency preparedness plan. You may use a spill prevention control and countermeasure (SPCC) plan prepared under 40 CFR part 112 if the plan includes all of the information required by this section. You must submit:
(a) A list of names, addresses, and telephone numbers of persons that the Superintendent can contact in the event of a spill, fire, or accident, including the order in which the persons should be contacted;
(b) Your reporting procedures in the event of a spill, fire, or accident;
(c) Identification of contaminating or toxic substances expected to be used within your area of operations;
(d) Identification of abnormal pressure, temperature, toxic gases or substances, or other hazardous conditions expected to be encountered during operations;
(e) Measures (
(f) Steps to prevent conditions creating fire hazards in the vicinity of well locations and lease tanks;
(g) List of equipment and methods for containment and cleanup of contaminating substances, including a list of the equipment to be maintained on site as well as a list of equipment to be available from local contractors;
(h) A storm water drainage plan and actions intended to mitigate storm water runoff;
(i) Safety data sheets for each material expected to be used or encountered during operations, including quantities expected to be maintained at your area of operations;
(j) A description of the emergency actions you will take in the event of accidents causing human injury; and
(k) Contingency plans for relevant conditions and emergencies other than spills, based on the particular geographic area, such as hurricanes, flooding, tornadoes, or earthquakes.
If you propose to conduct geophysical exploration, you must submit the following additional information:
(a) The number of crews and expected numbers of workers in each crew;
(b) Names and depths of geologic zones targeted for imaging;
(c) A description of the acquisition methods, including the procedures, specific equipment you will use, and energy sources (
(d) The methods of access along each survey line for personnel, materials, and equipment;
(e) A list of all explosives, blasting equipment, chemicals, and fuels you will use in the proposed operations, including a description of proposed disposal methods, transportation methods, safety measures, and storage facilities; and
(f) A map showing the positions of each survey line including all source and receiver locations as determined by a locational survey, and including shotpoint offset distances from wells, buildings, other infrastructure, and
If you are proposing to drill a well, you must submit the following additional information:
(a) Well-pad construction plans, including dimensions and cross sections of: cut and fill areas and excavations for ditches, sumps, and spill control equipment or structures, including lined areas;
(b) Drill-rig and equipment layout plans, including rig components, fuel tanks, testing equipment, support facilities, storage areas, and all other well-site equipment and facilities;
(c) The drilling program, including hole size for each section and the directional program, if applicable;
(d) Proposed drilling depth and the estimated depths and names of usable water, brine, hydrocarbon, geothermal, or other mineral-bearing zones;
(e) The type and characteristics of the proposed mud systems;
(f) The casing program, including the size, grade, weight, and setting depth of each string;
(g) The cementing program, including downhole location of any stage equipment, cement types, volumes, and additives to be used, and a description of pressure tests and cement verification techniques used that will be run to evaluate cement placement and integrity;
(h) The minimum specifications for pressure control equipment function, and pressure testing frequency, and the blowout preventer stack arrangement;
(i) The proposed logging, coring, and testing programs;
(j) The completion program, including completion type (open-hole, perforated, slotted liner, etc.), any proposed stimulation techniques, and procedures, including considerations for well control; and
(k) A description of the equipment, materials, and procedures for well plugging, including plug depths, plug types, and minimum mud weight.
If you are proposing well stimulation operations, including hydraulic fracturing, you must submit the following additional information:
(a) The geologic names, a geologic description, and the estimated depths (measured and true vertical) to the top and bottom of the target formation(s). The estimated minimum vertical distance between the top of the completion zone and the nearest usable water zone, and the measured depth of the proposed perforated or open-hole interval.
(b) The estimated depths (measured and true vertical) to the top and bottom of the confining zone(s). Include a map showing the location, orientation, and extent of any known or suspected faults or fractures within one-half mile (horizontal distance) of the wellbore trajectory that may transect the confining zone(s).
(c) A map showing all existing wellbore trajectories, regardless of type, within one-half mile (horizontal distance) of any portion of the wellbore into which hydraulic fracturing fluids are to be injected. The true vertical depth of each wellbore identified on the map must be indicated.
(d) Steps to be taken before well completions to verify mechanical integrity of all downhole tubulars and tools and cement quality, including pressure tests, monitoring of cement returns to surface, and cement evaluation logs (or other logs acceptable to the Superintendent) demonstrating that the occurrences of usable water zones have been isolated to protect them from contamination.
(e) A detailed description of the proposed well-stimulation design, including:
(1) The total proposed volume of stimulation fluid to be used; total proposed base fluid volume, description of proposed base fluid, and each additive in the proposed stimulation fluid, including the trade name, supplier, purpose, ingredients; Chemical Abstract Service Number (CAS); maximum ingredient concentration in additive (percent by mass); and maximum ingredient concentration in hydraulic fracturing fluid (percent by mass);
(2) Proposed proppant system if applicable;
(3) The anticipated surface treating pressure range;
(4) The maximum anticipated surface pressure that will be applied during the hydraulic fracturing process;
(5) The trajectory of the wellbore into which hydraulic fracturing fluids are to be injected and the estimated direction and length of the fractures that will be propagated and a notation indicating the true vertical depth of the top and bottom of the fractures; and
(6) Any microseismic monitoring planned or proposed in conjunction with well stimulation.
(f) The source and location of water supply, such as reused or recycled water, rivers, creeks, springs, lakes, ponds, and water supply wells, and the source and location of water supply, such as reused or recycled water, rivers, creeks, springs, lakes, ponds, and water supply wells.
(g) The storage, mixing, pumping, and control equipment needed to perform the stimulation.
(h) The following information concerning the handling of recovered fluids:
(1) The estimated volume of stimulation fluids to be recovered during flow back;
(2) The proposed methods of handling the recovered fluids including any onsite treatment for re-use of fluids in other stimulation activities; and
(3) The proposed disposal method of the recovered fluids, including, but not limited to, injection, hauling by truck, or transporting by pipeline.
If you are proposing production operations, you must submit the following information:
(a) The dimensions with a to-scale layout of the wellpad, clearly identifying well locations, noting partial reclamation areas; gathering, separation, metering, and storage equipment; electrical lines; fences; spill control equipment or structures including lined areas, artificial lift equipment, tank batteries, treating and separating vessels, secondary or enhanced recovery facilities, water disposal facilities, gas compression and/or injection facilities; metering points; sales point (if on lease); tanker pick-up points; gas compressor, including size and type (if applicable); and any other well site equipment;
(b) The size, grade, weight, and setting depth of all casing and tubing strings; cementing history; type and size of packers and subsurface flow control devices; top and bottom depths of each completed interval; and method of completion;
(c) The well history, including completions, stimulations, servicing, and workovers;
(d) The minimum specifications for pressure-control equipment, function, and pressure-testing frequency;
(e) The methods and means to be used to transport produced oil and gas, including vehicular transport; flowline and gathering line construction; operation; pipe size; operating pressure; cathodic protection methods; surface equipment use; surface equipment location; maintenance procedures; maintenance schedules; pressure detection methods; and shutdown procedures;
(f) Road and wellpad maintenance plan, including equipment and materials to maintain the road surface and control erosion;
(g) Vegetation management plan on well sites, roads, pipeline corridors, and other disturbed surface areas, including control of exotic species;
(h) Storm water management plan on the well site;
(i) Produced water storage and disposal plan; and
(j) The procedures for well plugging, the depths and the types of plugs, and minimum mud weight.
If you propose operations in System units, other than Big Cypress National Preserve, we will process your application in accordance with §§ 9.101 through 9.104. If you propose operations in Big Cypress National Preserve, we will process your application in accordance with §§ 9.103 and 9.105.
(a) Within 30 days after receipt of your application, the Superintendent will notify you in writing that either:
(1) Your application is complete and the NPS will begin formal review;
(2) Your permit application does not meet the information requirements and additional information is required before the NPS will conduct formal review of your permit application; or
(3) More time is necessary to complete the review, in which case the NPS will provide you an estimate of the amount of additional time reasonably needed and an explanation for the delay.
(b) If you resubmit information requested by the NPS under this section and the Superintendent determines that you have met all applicable information requirements, the Superintendent will notify you within 30 days after receipt of the additional information that either:
(1) Your application is complete and the NPS will begin formal review; or
(2) More time is necessary to complete the review, in which case the NPS will provide you an estimate of the amount of additional time reasonably needed and an explanation for the delay.
(a) The Superintendent will evaluate the potential impacts of your proposal on federally owned or administered lands, waters, or resources within System units, visitor uses and experiences, and visitor and employee health and safety. As part of this evaluation process, the NPS will comply with all applicable federal laws, including the National Environmental Policy Act. The Superintendent will then make a recommendation to the Regional Director regarding final action on your operations permit.
(b) As part of the evaluation process, the Superintendent may consult with other Federal, State, and local agencies.
(a) The Regional Director will approve your operations permit if the NPS has determined that your operations:
(1) Will not violate the laws governing administration of units of the National Park System; and
(2) Will meet all applicable operating standards.
(b) Before approval of your operations permit, you must submit to the Superintendent:
(1) Financial assurance in the amount specified by the Regional Director and in accordance with the requirements of §§ 9.140 through 9.144;
(2) Proof of liability insurance with limits sufficient to cover injuries to persons or property caused by your operations; and
(3) An affidavit stating that the operations planned are in compliance with all applicable Federal, State, and local laws and regulations.
(a) The Regional Director will take final action within 30 days of completing all required legal compliance, including compliance with the National Environmental Policy Act, unless:
(1) We and you agree that such final action will occur within a shorter or longer period of time; or
(2) We determine that an additional period of time is required to ensure that we have, in reviewing the permit application, complied with all applicable legal requirements.
(b) The Regional Director will notify you in writing that your operations permit is:
(1) Approved with the operating conditions contained therein; or
(2) Denied, and provide you justification for the denial. Any such denial must be consistent with § 9.30(c).
(a) Within 30 days after the date of submission of your application, we will notify you whether the application contains all information reasonably necessary to allow us to consider the application and, if not, will request that you provide additional information. After receiving this notification, you must either supply any reasonably necessary additional information or must notify us that you believe that the application contains all reasonably necessary information and is therefore complete; whereupon we may:
(1) Within 30 days after receipt of the notice from the applicant, determine that the application does not contain all reasonably necessary additional information and, on that basis, deny the application; or
(2) Review the application and take final action within 60 days after the date that you provided notification to the NPS that your application is complete.
(b) The Regional Director will take final action within 90 days after the date you submitted your application unless:
(1) We and you agree that final action can occur within a shorter or longer period of time; or
(2) We determine that an additional period of time is required to ensure that we have, in reviewing the permit application, complied with other applicable laws, executive orders, and regulations.
(a) You must comply with all operating standards in §§ 9.111 through 9.116, as well as with the standards in §§ 9.117 and 9.118, if applicable. The standards apply only to operations that occur within a System unit, including downhole activities, and do not apply to surface activities located outside a System unit. These operating standards are incorporated into the terms and conditions of your operations permit. Violation of these operating standards will subject you to the prohibitions and penalties provisions of §§ 9.180 through 9.182.
(b) NPS operating standards are applied to ensure protection of federally owned or administered lands, waters, and resources of System units, visitor uses and experiences, and visitor and employee health and safety. The operating standards give us and the operator flexibility to consider using alternative methods, equipment, materials design, and conduct of operations.
(c) In applying standards to a particular operation, you must use technologically feasible, least damaging methods to protect federally owned or administered lands, waters, and
(a) You must not conduct operations within 500 feet of surface water, including an intermittent or ephemeral watercourse, or wetland; within 500 feet of the mean high tide line; or within 500 feet of any structure or facility used by the NPS for interpretation, public recreation, or administration. The Superintendent may increase or decrease this distance consistent with the need to protect federally owned or administered lands, water, or resources of System units, visitor uses or experiences, or visitor or employee health and safety while ensuring that you have reasonable access to your non-Federal oil and gas rights. Measurements for purposes are by horizontal distance.
(b) You must design, construct, operate, and maintain access to your operational site to cause the minimum amount of surface disturbance needed to safely conduct operations and to avoid areas the NPS has indicated to you as sensitive resources.
(c) You must install and maintain secondary containment materials and structures for all equipment and facilities using or storing contaminating substances. The containment system must be sufficiently impervious to prevent discharge and must have sufficient storage capacity to contain, at a minimum, the largest potential spill incident.
(d) You must keep temporarily stored waste in the smallest feasible area, and confine in a manner appropriate to prevent escape as a result of percolation, rain, high water, or other causes. You must regularly remove waste from the System unit and dispose of it in a lawful manner. Nothing in this subpart affects the application of the regulations found at 36 CFR part 6.
(e) You must use engines that adhere to applicable Federal and State emission standards.
(f) You must construct, maintain, and use roads to minimize fugitive dust.
(g) You must use equipment and practices that minimize releases of air pollutants and hydrocarbons, and flaring of gas.
(h) You must conduct operation in a manner that does not create an unsafe environment for fish and wildlife by avoiding or minimizing exposure to physical and chemical hazards.
(i) You must conduct operations in a manner that avoids or minimizes impacts to sensitive wildlife, including timing and location of operations.
(j) You must control the invasion of exotic plant and animal species in your area of operations from the beginning through final reclamation.
(a) You must maintain hydrologic connectivity between surface water and groundwater during all operations.
(b) You must not cause measurable degradation of surface water or groundwater.
(c) You must conduct operations in a manner that maintains natural channel and floodplain processes and functions.
(a) You must maintain your area of operations in a manner that avoids or minimizes the cause or spread of fires and does not intensify fires originating outside your operations area.
(b) You must maintain site security, structures, facilities, improvements, and equipment in a safe and professional manner in order to provide a safe environment for park resources, park visitors, and NPS employees, free from exposure to physical and chemical hazards.
(a) You must design, shield, and focus lighting to minimize the effects of spill light on the night sky or adjacent areas.
(b) You must reduce visual contrast in the landscape by selecting the area of operations, avoiding unnecessary disturbance, choosing appropriate colors for permanent facilities, and other means.
(c) You must use road and pad materials similar in composition to soils in surrounding profiles whenever feasible.
You must prevent or minimize all noise that:
(a) Adversely affects the natural soundscape or other park resources or values, taking into account frequency, magnitude, or duration; or
(b) Exceeds levels that have been identified through monitoring as being acceptable to or appropriate for visitor uses at the sites being monitored.
(a) You must promptly clean up and remove any released contaminating substances and provide documentation to the Superintendent that the substances were disposed of in accordance with all applicable Federal, State, and local laws.
(b) You must perform partial reclamation of areas no longer necessary to conduct operations. You must begin final reclamation as soon as possible but no later than 6 months after you complete your permitted operations unless the Regional Director authorizes a longer period in writing.
(c) You must protect all survey monuments, witness corners, reference monuments, and bearing trees against destruction, obliteration, or damage from operations. You are responsible for reestablishing, restoring, and referencing any monuments, corners, and bearing trees that are destroyed, obliterated, or damaged by your operations.
(d) You must complete reclamation by:
(1) Plugging all wells;
(2) Removing all above-ground structures, equipment, and roads and all other man-made material and debris resulting from operations;
(3) Removing or neutralizing any contaminating substances;
(4) Reestablishing native vegetative communities, or providing for conditions where ecological processes typical of the ecological zone (
(5) Grading to reasonably conform the contours to preexisting elevations that are most appropriate to maximizing ecologic functional value;
(6) Restoring conditions to pre-disturbance hydrologic movement and functionality;
(7) Restoring natural systems using native soil material that is similar in character to the adjacent undisturbed soil profiles;
(8) Ensuring that reclaimed areas do not interfere with visitor use or with administration of the unit;
(9) Meeting conditions compatible with the management objectives of the park; and
(10) Ensuring proper and equitable apportionment of reclamation responsibilities by coordinating with us or with other operators who may be using a portion of your area of operations.
If you conduct geophysical operations, you must do all of the following:
(a) Use surveying methods that minimize the need for vegetative trimming and removal;
(b) Locate source points using industry-accepted minimum safe-offset
(c) Use equipment and methods that, based upon the specific environment, will minimize impacts to federally owned or administered lands, waters, and resources of System units, visitor uses and experiences, and visitor and employee health and safety; and
(d) If you use shot holes, you must:
(1) Use biodegradable charges;
(2) Plug all shot holes to prevent a pathway for migration for fluids along any portion of the bore; and
(3) Leave the site in a clean and safe condition that will not impede surface reclamation or pose a hazard to human health and safety.
If you conduct drilling, stimulation, and production operations, you must meet all of the standards in this section.
(a)
(2) You must not create earthen pits for any use. Earthen pits used solely for secondary containment on sites existing before December 5, 2016 may continue in use; however, the Superintendent may require such structures to be lined or removed depending on site-specific operational and environmental conditions.
(3) You must take all necessary precautions to keep your wells under control at all times, use only contractors or employees trained and competent to drill and operate the wells, and use only oil field equipment and practices generally used in the industry.
(4) You must design, implement, and maintain integrated casing, cementing, drilling fluid, completion, stimulation, and blowout prevention programs. These programs must be based upon sound engineering principles to prevent escape of fluids to the surface and to isolate and protect usable water zones throughout the life of the well, taking into account all relevant geologic and engineering factors.
(b)
(2) You must continuously monitor and record the treating pressures and all annular pressures before, during, and after the treatment to ensure that treatment materials are directed to the intended zone.
(3) If mechanical integrity is lost during the treatment, you must immediately cease the operation and notify the Superintendent as soon as feasible, but no later than 24 hours after the incident. Within 15 days after the occurrence, you must submit to the Superintendent a report containing all details pertaining to the incident, including corrective actions taken.
(c)
(2) You must maintain your well to prevent escape of fluids to the surface and to isolate and protect usable water zones throughout the life of the well, taking into account all relevant geologic and engineering factors.
(3) You must identify wells and related facilities by a sign, which must remain in place until the well is plugged and abandoned and the related facilities are closed. The sign must be of durable construction, and the lettering must be legible and large enough to be read under normal conditions at a distance of at least 50 feet. Each sign must show the name of the well, name of the operator, and the emergency contact phone number.
(4) You must remove all equipment and materials that are no longer needed for a particular phase of your operation.
(5) You must plug all wells to:
(i) Prevent a pathway of migration for fluids along any portion of the bore; and
(ii) Leave the surface in a clean and safe condition that will not impede surface reclamation or pose a hazard to human health and safety.
The following terms and conditions apply to all operators:
(a) The operator/permittee is responsible for ensuring that all of its employees and contractors and subcontractors comply fully with all of the requirements of this subpart;
(b) The operator/permittee may not use any surface water or groundwater owned or administered by the United States that has been diverted or withdrawn from a source located within the boundaries of a System unit unless the use has been approved in accordance with NPS policy;
(c) The operator/permittee must provide the NPS an affidavit, signed by an official who is authorized to legally bind the company, stating that proposed operations are in compliance with all applicable federal, state, and local laws and regulations and that all information submitted to the NPS is true and correct;
(d) The operator/permittee must agree to indemnify and hold harmless the United States and its officers and employees from and against any and all liability of any kind whatsoever arising out of or resulting from the acts or omissions of the operator and its employees, agents, representatives, contractors, and subcontractors in the conduct of activities under the operations permit; and
(e) The operator/permittee must agree to take all reasonable precautions to avoid, minimize, rectify, or reduce the overall impacts of your proposed oil and gas activities to System units. You may be required to mitigate for impacts to NPS resources and lost uses. Mutually agreed-upon mitigation tools for this purpose may include providing or restoring alternative habitat and resources to offset those impacts by the operations.
(a) The NPS may access your area of operations at any time to monitor the potential effects of the operations and to ensure compliance with this subpart where applicable.
(b) The Regional Director may determine that third-party monitors are required when necessary to protect federally owned or administered lands, waters, or resources of System units, visitor uses or experiences, or visitor or employee health and safety.
(1) The Regional Director's determination will be based on the scope and complexity of the proposed operation and whether the park has the staff and technical ability to ensure compliance with the operations permit and any provision of this subpart.
(2) A third-party monitor will report directly to the NPS at intervals determined by the Superintendent, and you will be responsible for the cost of the third party monitor. We will make the information reported available to you upon your request.
(3) Third party monitors must disclose to the NPS any potential conflicts of interest that could preclude objectivity in monitoring an operator's compliance with the operations permit and any provision of this subpart.
(c) You must notify the Superintendent of any accidents involving serious personal injury or death and of any fires or spills on the site as soon as feasible, but no later than 24 hours after the accident occurs. You must submit a full written report on the
(d) You must notify the Superintendent as soon as feasible, but no later than 24 hours after the discovery of any cultural or scientific resource you encounter that might be altered or destroyed by your operation. You must cease operations if necessary and leave the discovered resource intact until the Superintendent provides you with instructions. The Superintendent will determine, within 10 working days after notification what action will be taken with respect to the discovery.
(e) Upon the Superintendent's request, you must submit reports or other information necessary to verify compliance with your permit or with any provision of this subpart. To fulfill this request, you may submit to the NPS reports that you have submitted to the State under State regulations, or that you have submitted to any other Federal agency.
If your operations include hydraulic fracturing, you must provide the Superintendent with a report including all of the following details of the stimulation within 30 days after the completion of the last stage of hydraulic fracturing operations for each well:
(a) The true vertical depth of the well; total water volume used; a description of the base fluid and each additive in the hydraulic fracturing fluid, including the trade name, supplier, purpose, ingredients; Chemical Abstract Service Number (CAS); maximum ingredient concentration in additive (percent by mass); and maximum ingredient concentration in hydraulic fracturing fluid (percent by mass). This information may be submitted to the Superintendent through FracFocus or another existing database available to the public;
(b) The actual source(s) and location(s) of the water used in the hydraulic fracturing fluid;
(c) The maximum surface pressure and rate at the end of each stage of the hydraulic fracturing operation and the actual flush volume;
(d) The actual, estimated, or calculated fracture length, height and direction;
(e) The actual measured depth of perforations or the open-hole interval;
(f) The actual volume of stimulation fluids recovered during flow back, including a description of how the volumes were measured or calculated;
(g) The following information concerning the handling of fluids recovered, covering the period between the commencement of hydraulic fracturing and the implementation of the approved permit for the disposal of produced water under NPS requirements:
(1) The methods of handling the recovered fluids, including, but not limited to, transfer pipes and tankers, holding pond use, re-use for other stimulation activities, or injection; and
(2) The disposal method of the recovered fluids, including, but not limited to, the percent injected, the percent stored at an off-lease disposal facility, and the percent recycled; and
(h) Continuous monitoring records of annulus pressure at the bradenhead and other annular pressures that document pressures before, during, and after injection operations. You must submit a signed certification that wellbore integrity was maintained throughout the operation.
The Regional Director may grant you the privilege of access, subject to the provisions of any applicable law, on, across, or through federally owned or administered lands or waters in any System unit outside of Alaska to reach the boundary of your oil and gas right.
(a) Except as provided in paragraph (b) of this section, the Regional Director may charge you a fee if you use federally owned or administered lands or waters that are outside the scope of your oil and gas right.
(1) If you require the use of federally owned or administered lands or waters to access your operation, the Regional Director will charge you a fee based on the fair market value of such use.
(2) If access to your mineral right is on or across an existing park road, the Regional Director may charge you a fee according to a posted fee schedule.
(b) Fees under this section will not be charged for access within the scope of your oil and gas right or access to your mineral right that is otherwise provided for by law.
The Regional Director will not charge a fee for access across federally owned or administered lands beyond the scope of your oil and gas right as necessary to respond to an emergency situation at your area of operations if the Regional Director determines that the circumstances require an immediate response to either:
(a) Prevent or to minimize injury to park resources; or
(b) Ensure public health and safety.
Yes. You must file financial assurance with us in a form acceptable to the Regional Director and payable upon demand. This financial assurance is in addition to any financial assurance required by any other regulatory authority.
We base the financial assurance amount upon the estimated cost for a third-party contractor to complete reclamation in accordance with this subpart. If the cost of reclamation exceeds the amount of your financial assurance, you remain liable for all costs of reclamation in excess of the financial assurance.
The Regional Director may require, or you may request, an adjustment to the financial assurance amount because of any circumstance that increases or decreases the estimated costs established under § 9.141.
We will release your financial assurance within 30 days after the Regional Director:
(a) Determines that you have met all applicable reclamation operating standards and any additional reclamation requirements that may be included in your operations permit; or
(b) Accepts a new operator's financial assurance under § 9.160(b) or (c).
(a) We will retain all or part of your financial assurance if compliance with your reclamation responsibilities under the approved permit or any provisions of this subpart is incomplete.
(b) In addition, we may also:
(1) Prohibit you from removing all structures, equipment, or other materials from your area of operations;
(2) Require you to secure the operations site and take any necessary actions to protect federally owned or administered lands, waters, or resources of System units, visitor uses or experiences, or visitor or employee health and safety; and
(3) Suspend review of any permit applications you have submitted until the Regional Director determines that all violations of permit provisions or of any provision of this subpart are resolved.
(4) Seek recovery as provided in § 9.141 for all costs of reclamation in excess of the posted financial assurance.
(a) You may request modification to a temporary access permit or operations permit by providing the Regional Director with written notice describing the modification and why you think it is needed.
(b) The Regional Director may propose to modify an approved temporary access or operations permit to address changed or unanticipated conditions within your area of operations. You will be notified in writing of the proposed modifications and the justifications therefore, and the time within which you must either notify the Regional Director that you accept the modifications to your permit or explain any concerns you may have
(c) The Regional Director will review requests made under paragraph (a) of this section or responses provided under paragraph (b) of this section applying the approval standards and timeframes at § 9.62 or § 9.104, respectively. You will be notified in writing of the Regional Director's decision and any revisions approved to the terms of the permit.
(a) You must notify the Superintendent in writing within 30 calendar days after the date the new owner acquires the rights to conduct operations. Your written notification must include:
(1) The names and contact information of the person or entity conveying the oil or gas right, and the names and contact information of the person or entity acquiring the oil or gas right;
(2) The effective date of transfer;
(3) The description of the rights, assets, and liabilities being transferred and those being reserved by the previous owner; and
(4) A written acknowledgement from the new owner that the contents of the notification are true and correct.
(b) Until you meet the requirements of this section and the Regional Director provides notice to you that the new operator has complied with § 9.161(a) you remain responsible for compliance with your operations permit, and we will retain your financial assurance.
(c) If you were operating without an operations permit, you are subject to §§ 9.120 through 9.122 and §§ 9.180 through 9.182 until the new operator meets the requirements of this section and the Regional Director provides notice to you that the new operator has complied with § 9.161(b) or (c), as applicable.
(a) If you acquire rights to conduct operations, you must provide to the Superintendent:
(1) Written acknowledgment that you adopt the previous operator's operations permit, and that you agree to conduct operations in accordance with all terms and conditions thereof, or that you adopt the previous operator's operations permit and are also requesting approval for modification of the previous operator's permit consistent with the procedures at § 9.150;
(2) Financial assurance in the amount specified by the Regional Director and in accordance with the requirements of §§ 9.140 through 9.144;
(3) Proof of liability insurance with limits sufficient to cover injuries to persons or property caused by your operations; and
(4) An affidavit stating that your operations are in compliance with all applicable Federal, State, and local laws and regulations.
(b) If the previous operator was granted an exemption under § 9.72, you must provide the Superintendent the following information within 30 calendar days after the date you acquire the rights to conduct operations:
(1) Right to operate documentation demonstrating that you are the successor in interest to the previous operator's right, and the extent of such right, to operate within the System unit; and
(2) The names and contact information of:
(i) The operator;
(ii) The owner; and
(iii) The individuals responsible for overall management, field supervision, and emergency response of the proposed operations.
(c) If the previous operator was operating without an operations permit, you will be considered a previously exempt operator and must obtain an operations permit. Within 90 days after acquiring the rights to conduct operations, you must submit the information at § 9.51(a) through (j), and your operations permit application will be processed in accordance with §§ 9.52 and 9.53.
Except as provided in § 9.171, you must plug your well when any of the following occurs:
(a) Your drilling operations have ended and you have taken no further action to produce the well within 60 days;
(b) Your well, which has been completed for production operations, has no measureable production quantities for 12 consecutive months; or
(c) The period approved in your operations permit to maintain your well in shut-in status has expired.
(a) You may apply for either a modification to your approved operations permit or, in the case of previously exempt operations, an operations permit to maintain your well in a shut-in status for up to 5 years. The application must include:
(1) An explanation of why the well is shut-in or temporarily abandoned and your future plans for utilization;
(2) Proof of the mechanical integrity of both surface and production casing demonstrating that no migration of fluid can be expected to occur; and
(3) A description of the manner in which your well, equipment, and area of operations will be maintained.
(b) Based on the information provided under this section, the Regional Director may approve your application to maintain your well in shut-in status for a period up to 5 years. You may apply for additional extensions by submitting a new application under paragraph (a) of this section.
The following are prohibited:
(a) Operating in violation of the terms or conditions of a temporary access permit, or an approved operations permit, or any provision of this subpart;
(b) Damaging federally owned or administered lands, waters, or resources of a System unit as a result of violation of the terms or conditions of a temporary access permit, an operations permit, or any provision of this subpart;
(c) Conducting operations or activities without a required permit;
(d) Failure to comply with any suspension or revocation order issued under this subpart; and
(e) Failure to comply with any applicable Federal law or regulation, or
If you engage in a prohibited act described in § 9.180:
(a) You may be subject to a fine or imprisonment, or both, in accordance with 36 CFR 1.3;
(b) The Superintendent may suspend your operations; or
(c) The Regional Director may revoke your approved temporary access permit or operations permit.
Until you are in compliance with this subpart or the terms and conditions of an existing temporary access permit or operations permit, we will not consider any new permit requests to conduct operations within any System unit.
Yes. If you disagree with a decision of the Regional Director under this subpart, you may file with the Regional Director a written statement describing the alleged factual or legal errors in the original decision and requesting that the Regional Director reconsider the decision. You must file your request for reconsideration within 60 calendar days after your receipt of the Regional Director's decision. The NPS will dismiss as untimely any request for reconsideration received more than 60 days after your receipt of the original decision.
The Regional Director will review his or her original decision and, within 90 days after receipt of your appeal, provide you with a written statement reversing, affirming, or modifying that decision, unless the Regional Director notifies you that he or she needs additional time to review the original decision. When issued, that written statement constitutes the Regional Director's final decision on the matter.
(a) If the Regional Director affirms or modifies his or her original decision after you file a request for reconsideration, you may file an appeal with the NPS Director within 60 calendar days after your receipt of the Regional Director's decision under § 9.191.
(b) Your appeal must include a statement of exceptions specifying your specific disagreements with the Regional Director's final decision. If you do not file your appeal within 60 calendar days, your appeal will be dismissed as untimely.
(c) If you timely file your statement of exceptions, the Regional Director will forward his or her decision and the record for the appeal to the NPS Director. The record will consist of all documents and materials considered by NPS that are related to the matter appealed. The Regional Director will maintain that record under separate cover and will certify that the decision was based on that record. The Regional Director will make a copy of the record available to you at your request.
(d) If, upon review, the NPS Director considers the record inadequate, the NPS Director may require additional documentation or information, or may remand the matter to the Regional Director with instructions for further action.
(e) Within 45 calendar days from the date the NPS Director receives your statement of exceptions, the Director will issue a written decision. If the Director requires more than 45 calendar days to reach a decision, the Director will notify you and specify the reasons for the delay. The Director's written decision will include:
(1) A statement of facts;
(2) A statement of conclusions; and
(3) An explanation of the basis for the decision.
(f) No NPS decision under these regulations that is subject to appeal to the Director, or the Regional Director pursuant to § 9.194, will be considered final agency action subject to judicial review under 5 U.S.C. 704 unless the appropriate official has rendered a decision on the matter. That decision will constitute NPS's final agency action, and no further appeal will lie in the Department from that decision.
(a) Except as provided for in paragraph (b) of this section, during the reconsideration and appeal processes, the decision at issue will be stayed (suspended). The decision will not become effective until the appeals process is completed.
(b) If NPS suspends your operation due to an emergency within your area of operation that poses an immediate threat of injury to federally owned or administered lands or waters, or to public health and safety, you have a right to request reconsideration and appeal the decision under §§ 9.190 through 9.194, but the suspension will not be stayed until the threat is eliminated.
Where the Superintendent has the authority to make the original decision, requests for reconsideration and appeals may be filed in the manner provided by §§ 9.190 through 9.193, except that:
(a) The request for reconsideration will be filed with and decided by the Superintendent;
(b) The appeal will be filed with and decided by the Regional Director; and
(c) The Regional Director's decision will constitute the final agency action on the matter.
(a) Interested parties may view the publicly available documents at the Superintendent's office during normal business hours or by other means prescribed by the Superintendent. The availability for public inspection of information about the nature, location, character, or ownership of park resources will conform to all applicable law and implementing regulations, standards, and guidelines.
(b) The Superintendent will make available for public inspection any documents that an operator submits to the NPS under this subpart except those that you have identified as proprietary or confidential.
(c) For the information required in §§ 9.88, 9.89, and 9.122, the operator and the submitter of the information will be deemed to have waived any right to protect from public disclosure information submitted to the NPS. For information required under §§ 9.88, 9.89, and 9.122 that the owner of the information claims to be exempt from public disclosure and is withheld from the NPS, a corporate officer, managing partner, or sole proprietor of the operator must sign and the operator must submit to the Superintendent an affidavit that:
(1) Identifies the owner of the withheld information and provides the name, address and contact information for a corporate officer, managing partner, or sole proprietor of the owner of the information;
(2) Identifies the Federal statute or regulation that would prohibit the NPS from publicly disclosing the information if it were in the NPS's possession;
(3) Affirms that the operator has been provided the withheld information from the owner of the information and is maintaining records of the withheld information, or that the operator has
(4) Affirms that the information is not publicly available;
(5) Affirms that the information is not required to be publicly disclosed under any applicable local, State, tribal, or Federal law;
(6) Affirms that the owner of the information is in actual competition and identifies competitors or others that could use the withheld information to cause the owner of the information substantial competitive harm;
(7) Affirms that the release of the information would likely cause substantial competitive harm to the owner of the information and provides the factual basis for that affirmation; and
(8) Affirms that the information is not readily apparent through reverse engineering with publicly available information.
(d) If the operator relies upon information from third parties, such as the owner of the withheld information, to make the affirmations in paragraphs (c)(6) through (8) of this section, the operator must provide a written affidavit from the third party that sets forth the relied-upon information.
(e) The NPS may require any operator to submit to the NPS any withheld information, and any information relevant to a claim that withheld information is exempt from public disclosure.
(f) If the NPS determines that the information submitted under paragraph (e) of this section is not exempt from disclosure, the NPS will make the information available to the public after providing the operator and owner of the information with no fewer than 10 business days' notice of the NPS's determination.
(g) The operator must maintain records of the withheld information until the later of the NPS's release of the operator's financial assurance or 7 years after completion of hydraulic fracturing operations. Any subsequent operator will be responsible for maintaining access to records required by this paragraph during its operation of the well. The operator will be deemed to be maintaining the records if it can promptly provide the complete and accurate information to NPS, even if the information is in the custody of its owner.
(h) If any of the chemical identity information required in § 9.122 is withheld, the operator must provide the generic chemical name in the submission required by § 9.122. The generic chemical name must be only as nonspecific as is necessary to protect the confidential chemical identity, and should be the same as or no less descriptive than the generic chemical name provided to the Environmental Protection Agency.
(a) The Office of Management and Budget (OMB) has reviewed and approved the information collection requirements in 36 CFR part 9, subpart B, and assigned OMB Control Number 1024-0274. We may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number. We use the information collected to:
(1) Evaluate proposed operations;
(2) Ensure that all necessary mitigation measures are employed to protect park resources and values; and
(3) Ensure compliance with all applicable laws and regulations.
(b) You may submit comments on any aspect of the information collection requirements to the Information Collection Clearance Officer, National Park Service, 12201 Sunrise Valley Drive, Room 2C114, Mail Stop 242, Reston, VA 20192.
Defense Acquisition Regulations System, Department of Defense (DoD).
Final rule.
DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to improve the effectiveness of independent research and development (IR&D) investments by the defense industrial base, by requiring contractors to engage in technical interchanges with DoD before costs are generated.
Effective November 4, 2016.
Mr. Tom Ruckdaschel, telephone 571-372-6088.
DoD published a proposed rule in the
DoD reviewed the public comments in the development of this final rule. A discussion of the comments and the changes made to the rule as a result of those comments is provided, as follows:
1. The requirement at DFARS 231.205-18(c)(iii)(C)(
2. DFARS 231.205-18(c)(iii)(C)(
Adequate controls are in place to protect information from compromise. It is DoD policy to protect national security information in accordance with national-level policy issuances. In accordance with DoD Instruction 5200.01, DoD Information Security Program and Protection of Sensitive Compartmented Information, DoD shall—
• Identify and protect national security information and controlled unclassified information (CUI) in accordance with national level policy issuances.
• Promote information sharing, facilitate judicious use of resources, and simplify management through implementation of uniform and standardized processes.
• Protect CUI from unauthorized disclosure by appropriately marking, safeguarding, disseminating, and destroying such information.
This final rule includes the following technical amendments:
1. The proposed paragraph regarding contractors that do not meet the threshold of major contractor is renumbered as DFARS 231.205-18(c)(iv) in the final rule.
2. At DFARS 242.771-3, the entity responsible for a regular method for communication is changed from the “Director, Defense Research and Engineering (USD(A&T)DDR&E)” to the “Office of the Assistant Secretary of Defense for Research and Engineering (OASD R&E).”
This rule does not add any new provisions or clauses or impact any existing provisions or clauses.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits
A final regulatory flexibility analysis has been prepared consistent with the Regulatory Flexibility Act, 5 U.S.C. 601,
The objective of this final rule is to (1) ensure that both independent research and development (IR&D) performers and their potential DoD customers have sufficient awareness of each other's efforts and (2) provide industry with feedback on the relevance of proposed and completed IR&D work.
There were no significant issues raised by the public in response to the initial regulatory flexibility analysis.
DoD does not expect this final rule to have a significant economic impact on a substantial number of small entities, because DFARS 231.205-18(c)(iii) applies only to major contractors, which are defined as those whose covered segments allocated a total of more than $11 million in IR&D and bid and proposal costs to covered contracts during the preceding fiscal year. The final rule requires major contractors to communicate proposed new IR&D efforts to DoD personnel in a technical interchange prior to the initiation of such investments.
This rule impacts existing reporting and recordkeeping requirements in a very minor way. Only one element is being added to the existing reporting requirement to require major contractors to include the name of the DoD employee with which a technical interchange was held and the date of such interchange.
There are no known significant alternatives to the rule. The rule impacts major contractors and, as such, will have minimal impact on small entities.
The final rule affects the information collection requirements at Defense Federal Acquisition Regulation Supplement (DFARS) 231.205-18, currently approved under the Office of Management and Budget (OMB) Control Number 0704-0483, entitled “Independent Research and Development Technical Descriptions,” in accordance with the Paperwork Reduction Act (44 U.S.C. chapter 35); however, the impact of this rule is negligible. Currently, contractors are required to (1) report IR&D projects to DTIC using the DTIC's online IR&D database and (2) update these inputs at least annually and when the project is completed. This rule merely changes the web address for submission of this report and requires major contractors to include in the report the name of the DoD Government employee with which a technical interchange was held and the date of such interchange.
Government procurement.
Therefore, 48 CFR parts 231 and 242 are amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
The revision and addition read as follows:
(c) * * *
(iii) * * *
(C) For annual IR&D costs to be allowable—
(
(
(
(
(
(
(iv) Contractors not meeting the threshold of a major contractor are encouraged to use the DTIC online input form to report IR&D projects to provide DoD with visibility into the technical content of the contractors' IR&D activities.
Defense Acquisition Regulations System, Department of Defense (DoD).
Final rule.
DoD is issuing a final rule to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to remove the acronym for contiguous United States.
Effective November 4, 2016.
Ms. Julie Hammond, telephone 571-372-6174.
DoD is amending the DFARS to remove the acronym for contiguous United States (CONUS). While the term “contiguous United States (CONUS)” is defined in Federal Acquisition Regulation (FAR) 2.101, the acronym is sometimes misinterpreted as “continental United States.” Spelling out the acronym in the DFARS will eliminate any confusion.
DFARS 274.301 is amended to update the reference to transportation guidance in DFARS Procedures, Guidance, and Information and, as a result, remove the acronym CONUS.
DFARS 274.301-71 is amended to spell out “the contiguous United States” in lieu of CONUS.
This case does not add any new provisions or clauses or impact any existing provisions or clauses.
The statute that applies to the publication of the FAR is 41 U.S.C. 1707 entitled “Publication of Proposed Regulations.” Paragraph (a)(1) of the statute requires that a procurement policy, regulation, procedure, or form (including an amendment or modification thereof) must be published for public comment if it relates to the expenditure of appropriated funds, and has either a significant effect beyond the internal operating procedures of the agency issuing the policy, regulation, procedure, or form, or has a significant cost or administrative impact on contractors or offerors. This final rule is not required to be published for public comment, because it is just removing and spelling out the acronym for “contiguous United States”.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
The Regulatory Flexibility Act does not apply to this rule because this final rule does not constitute a significant DFARS revision within the meaning of FAR 1.501-1, and 41 U.S.C. 1707 does not require publication for public comment.
The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Therefore, 48 CFR part 247 is amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
Defense Acquisition Regulations System, Department of Defense (DoD).
Final rule.
DoD is adopting as final, with changes, an interim rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2016 that changes the criteria for the pilot program for acquisition of military purpose nondevelopmental items.
Effective November 4, 2016.
Ms. Carrie Moore, telephone 571-372-6093.
DoD published an interim rule in the
DoD reviewed the public comments in the development of the final rule. A discussion of the comments received and the changes made to the rule as a result of those comments is provided, as follows:
One change is made in the final rule as a result of a public comment. The prescription at DFARS 212.7103 for DFARS provision 252.212-7002, Pilot Program for Acquisition of Military-Purpose Nondevelopmental Items, is revised to clarify its use in solicitations
The requirements of section 892 of the NDAA for FY 2016 do not apply to contracts at or below the SAT. Additionally, while FAR part 12 commercial procedures may be used to acquire military purpose nondevelopmental items under this pilot program, the rule does not apply to the acquisition of commercial items, including COTS items.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
A final regulatory flexibility analysis (FRFA) has been prepared consistent with the Regulatory Flexibility Act, 5 U.S.C. 601,
This final rule amends the Defense Federal Acquisition Regulation Supplement (DFARS) to implement section 892 of the National Defense Authorization Act for Fiscal Year 2016. The objective of the rule is to modify the criteria for the pilot program at DFARS 212.71, Pilot Program for the Acquisition of Military Purpose Nondevelopmental Items, to increase the opportunities for use of the program. The rule removes the criteria that contracts must be awarded to “nontraditional defense contractors” and awards must be made using competitive procedures. The rule also increases the dollar threshold for the program to allow use on procurements up to $100 million.
There were no significant issues raised by the public in response to the initial regulatory flexibility analysis provided in the interim rule.
The changes to the pilot program will have a positive economic impact on small businesses that did not meet the definition of “nontraditional defense contractors” and have developed products that could be applied to a military purpose. According to data available in the Federal Procurement Data System for FY 2015, 6,514 unique small businesses were awarded a DoD contract in excess of the certified cost and pricing threshold ($750,000) and therefore did not meet the definition of “nontraditional defense contractor.” Prior to the changes made by this rule these small businesses were not eligible for an award under the pilot program. These small businesses will now be able to participate in the pilot program if they are developing a military purpose nondevelopmental item.
This rule does not impose any new reporting, recordkeeping, or other compliance requirements. No significant alternatives were identified during the development of this rule.
The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Accordingly, the interim rule amending 48 CFR parts 212 and 252, which was published in the
41 U.S.C. 1303 and 48 CFR chapter 1.
Use the provision at 252.212-7002, Pilot Program for Acquisition of Military-Purpose Nondevelopmental Items, in solicitations when use of the pilot program is planned and the applicability criteria of 212.7102-1 are met.
Defense Acquisition Regulations System, Department of Defense (DoD).
Proposed rule.
DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to ensure that substantial future independent research and development expenses, as a means to reduce evaluated bid prices in competitive source selections, are evaluated in a uniform way during competitive source selections.
Comments on the proposed rule should be submitted in writing to the address shown below on or before January 3, 2017, to be considered in the formation of a final rule.
Submit comments identified by DFARS Case 2016-D017, using any of the following methods:
○
○
○
○
Comments received generally will be posted without change to
Mr. Mark Gomersall, telephone 571-372-6099.
As expressed in the “Implementation Directive for Better Buying Power 3.0—Achieving Dominant Capabilities through Technical Excellence and Innovation,” dated April 9, 2015, the Under Secretary of Defense for Acquisition, Technology, and Logistics noted a concern when “promised future IRAD [independent research and development] expenditures are used to substantially reduce the bid price on competitive procurements. In these cases, development price proposals are reduced by using a separate source of government funding (allowable IRAD overhead expenses spread across the total business) to gain a price advantage in a specific competitive bid. This is not the intended purpose of making IRAD an allowable cost.”
DoD published an advanced notice of proposed rulemaking (ANPR) in the
DoD is proposing to amend the DFARS to require contracting officers to adjust the total evaluated price of major defense acquisition programs and major automated information systems proposals, for evaluation purposes only, to include the amount by which the offerors propose that future independent research and development investments reduce the price of the proposals.
This rule proposes to create a new clause: DFARS 252.215-70XX, Notification of Inclusion of Evaluation Criteria for Reliance Upon Future Government-Reimbursed Independent Research and Development Investments. DoD plans not to apply this clause to contracts at or below the simplified acquisition threshold or to commercial items, including commercially available off-the-shelf items.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
DoD does not expect this proposed rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act 5 U.S.C. 601,
DoD is proposing to amend the DFARS to require contracting officers to adjust the total evaluated price of major defense acquisition programs and major automated information systems proposals, for evaluation purposes only, to include the amount by which the offerors propose that future independent research and development investments reduce the price of the proposals.
The objective of this rule is to ensure that substantial future independent research and development expenses, as a means to reduce evaluated bid prices in competitive source selections, are evaluated in a uniform way during competitive source selections.
The rule has limited application and will apply only to major defense acquisition programs (as defined in 10 U.S.C. 2430) and major automated information systems acquisitions (as defined in 10 U.S.C. 2445a). This rule should not impact small entities, since major defense acquisition programs and major automated information systems acquisition policies normally apply to large contractors, because the cost, magnitude, and production requirements of such programs are generally beyond the capability or capacity of small entities as prime contractors.
There is no change to reporting and recordkeeping as a result of this rule. The rule does not duplicate, overlap, or conflict with any other Federal rules. There are no known significant alternative approaches to the rule that would meet the requirements.
DoD invites comments from small business concerns and other interested
DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (DFARS Case 2016-D017), in correspondence.
The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Therefore, 48 CFR parts 215 and 252 are proposed to be amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
(a)(1)
(2) Use the provision at 252.215-70XX, Notification of Inclusion of Evaluation Criteria for Reliance Upon Future Government-Reimbursed Independent Research and Development Investments, in all competitive solicitations for major defense acquisition programs (as defined in 10 U.S.C. 2430) and major automated information systems acquisitions (as defined in 10 U.S.C. 2445a) in a development phase.
As prescribed in 215.408(2), use the following provision:
(a) This solicitation includes price evaluation criteria that consider the Offeror's intended use of future Government-reimbursed independent research and development (IR&D) projects if the Offeror proposes a cost or price that is reduced due to reliance upon expected future Government-reimbursed IR&D projects.
(b) If the Offeror, in the performance of any contract resulting from this solicitation, intends to use IR&D to meet the contract requirements, the Offeror's proposal shall include documentation in its price proposal to support this proposed approach.
(c) For evaluation purposes only, the Contracting Officer will adjust the Offeror's total evaluated cost or price to include the amount that such future IR&D investments reduce the price of the proposal.
(End of provision)
Defense Acquisition Regulations System, Department of Defense (DoD).
Proposed rule.
DoD is issuing a proposed rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2016 related to costs associated with indirect offsets under foreign military sales agreements.
Comments on the proposed rule should be submitted in writing to the address shown below on or before January 3, 2017, to be considered in the formation of a final rule.
Submit comments identified by DFARS Case 2015-D028, using any of the following methods:
○
○
○
○
Comments received generally will be posted without change to
Mr. Mark Gomersall, telephone 571-372-6099.
This proposed rule expands on interim rule guidance and incorporates the requirements of section 812 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2016.
DoD published an interim rule in the
DoD reviewed the public comments submitted in response to the interim rule in the development of this proposed rule. A discussion of the comments and the changes made to the rule as a result of those comments is provided, as follows:
Section 812 of the NDAA for FY 2016 amended 10 U.S.C. 2306a(b)(1) to state that submission of certified cost or pricing data shall not be required in the case of a contract, a subcontract, or modification of a contract or subcontract to the extent such data—
(i) Relates to an offset agreement in connection with a contract for the sale of a weapon system or defense-related item to a foreign country or foreign firm; and
(ii) Does not relate to a contract or subcontract under the offset agreement for work performed in such foreign country or by such foreign firm that is directly related to the weapon system or defense-related item being purchased under the contract.
This proposed rule amends DFARS 215.403-1(b), Exceptions to Certified Cost or Pricing Data Requirements, and adds DFARS clause 252.215-70XX, Requirements for Certified Cost or Pricing Data for Foreign Military Sales Indirect Offset Agreements, to incorporate the revisions implemented in section 812.
Additionally, this proposed rule relocates the language at DFARS Procedures, Guidance, and Information (PGI) 225.7303-2(a)(3) into DFARS 225.7303-2(a)(3) for clarity. In response to public comments, the rule also adds: (1) Definitions of “offset” and “offset costs” at 202.101, and (2) the appropriate reference to Federal Acquisition Regulation (FAR) part 15 and deletes the phrase “of a certain dollar value” in DFARS 225.7303-2(a)(3).
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
DoD does not expect this rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
This rule amends the DFARS to clarify requirements related to indirect offset costs associated with Foreign Military Sales offset agreements.
The objective of this rule is to expand on the DFARS interim rule published in the
DoD does not expect this rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
This rule does not add any reporting or recordkeeping requirements. The rule does not duplicate, overlap, or conflict with any other Federal rules. There are no known significant alternatives to this rule.
DoD invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.
DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C 610 (DFARS Case 2015-D028), in correspondence.
The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Therefore, 48 CFR parts 202, 215, 225, and 252 are proposed to be amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
(1) A direct offset involves benefits or obligations, including supplies or services, that are related to the item being purchased. For example, as a condition of a foreign military sale, the contractor may require or agree to permit the customer to produce in its country certain components or subsystems of the item being sold. Generally, direct offsets must be performed within a specified period, because they are integral to the deliverable of the FMS contract.
(2) An indirect offset involves benefits, including supplies or services, that are unrelated to the item being purchased. For example, as a condition of a foreign military sale, the contractor may agree to purchase certain manufactured products, agricultural commodities, raw materials, or services required by the FMS customer, or may agree to build a school or road. Indirect offsets may be accomplished without a clearly defined period of performance.
(b)
(ii) Submission of certified cost or pricing data shall not be required in the case of a contract, subcontract, or modification of a contract or subcontract to the extent such data relates to an indirect offset.
(6)
(
(
(a) * * *
(3)
(i) An offset agreement is the contractual arrangement between the FMS customer and the U.S. defense contractor that identifies the offset obligation imposed by the FMS customer that has been accepted by the U.S. defense contractor as a condition of the FMS customer's purchase. These agreements are distinct and independent of the LOA and the FMS contract. Further information about offsets and LOAs may be found in the Defense Security Cooperation Agency (DSCA) Security Assistance Management Manual (DSCA 5105.38-M), chapter 6, paragraph 6.3.9. (
(ii) A U.S. defense contractor may recover all costs incurred for offset agreements with a foreign government or international organization if the LOA is financed wholly with foreign government or international organization customer cash or repayable foreign military finance credits.
(iii) The U.S. Government assumes no obligation to satisfy or administer the offset agreement or to bear any of the associated costs.
(iv) Indirect offset costs are deemed reasonable for purposes of FAR parts 15 and 31 with no further analysis necessary on the part of the contracting officer, provided that the U.S. defense contractor submits to the contracting officer a signed offset agreement or other documentation showing that the FMS customer has made the provision of an indirect offset a condition of the FMS acquisition. FMS customers are placed on notice through the LOA that indirect offset costs are deemed reasonable without any further analysis by the contracting officer.
As prescribed in 215.408(6)(i), use the following clause:
(a)
(1) A direct offset involves benefits or obligations, including supplies or services, that are related to the item being purchased. For example, as a condition of a foreign military sale, the contractor may require or agree to permit the customer to produce in its country certain components or subsystems of the item being sold. Generally, direct offsets must be performed within a specified period because they are integral to the deliverable of the FMS contract.
(2) An indirect offset involves benefits, including supplies or services, that are unrelated to the item being purchased. For example, as a condition of a foreign military sale the contractor may agree to purchase certain manufactured products, agricultural commodities, raw materials, or services required by the FMS customer, or may agree to build a school or road. Indirect offsets may be accomplished without a clearly defined period of performance.
(b)
(End of clause)
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 |