| Page Range | 53397-54287 | |
| FR Document |
| Page and Subject | |
|---|---|
| 82 FR 53522 - Sunshine Act Meetings | |
| 82 FR 53426 - Department of the Treasury Acquisition Regulations; Tax Check Requirements | |
| 82 FR 53513 - California; Amendment No. 5 to Notice of a Major Disaster Declaration | |
| 82 FR 53514 - South Carolina; Amendment No. 1 to Notice of a Major Disaster Declaration | |
| 82 FR 53514 - Puerto Rico; Amendment No. 5 to Notice of a Major Disaster Declaration | |
| 82 FR 53515 - Puerto Rico; Amendment No. 4 to Notice of a Major Disaster Declaration | |
| 82 FR 53440 - United States Air Force 81st Security Forces Anti-Terrorism Office, Restricted Area, Keesler Air Force Base, Biloxi, Mississippi | |
| 82 FR 53422 - United States Navy Restricted Area, Menominee River, Marinette Marine Corporation Shipyard, Marinette, Wisconsin | |
| 82 FR 53438 - Establishment of a Permanent Restricted Area for U.S. Coast Guard Yard, Baltimore, Maryland, in Curtis Creek and Arundel Cove | |
| 82 FR 53555 - Notice of Determinations: Culturally Significant Object Imported for Exhibition Determinations: “Rembrandt's Self-Portrait at the Age of 34” Exhibition | |
| 82 FR 53553 - Notice of Issuance of a Presidential Permit to Enbridge Energy, Limited Partnership | |
| 82 FR 53442 - Repeal of Emission Requirements for Glider Vehicles, Glider Engines, and Glider Kits | |
| 82 FR 53503 - Agency Information Collection Activities: Submission for OMB Review; Comment Request | |
| 82 FR 53480 - Magnuson-Stevens Fishery Conservation and Management Act; General Provisions for Domestic Fisheries; Application for Exempted Fishing Permit | |
| 82 FR 53423 - Tebufenozide; Pesticide Tolerance Actions | |
| 82 FR 53430 - Fisheries of the Northeastern United States; Summer Flounder Fishery; Commercial Quota Harvested for the State of Rhode Island | |
| 82 FR 53516 - Agency Information Collection Activities; Probate of Indian Estates, Except for Members of the Osage Nation and Five Civilized Tribes | |
| 82 FR 53566 - Veterans and Community Oversight and Engagement Board, Notice of Meeting | |
| 82 FR 53521 - Polytetrafluoroethylene (“PTFE”) Resin From China and India | |
| 82 FR 53530 - Notice of Request for Certification of Texas Capital Counsel Mechanism | |
| 82 FR 53529 - Notice of Request for Certification of Arizona Capital Counsel Mechanism | |
| 82 FR 53528 - Notice of Lodging of the Proposed Second Amended Consent Decree Under the Clean Water Act | |
| 82 FR 53500 - Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS) | |
| 82 FR 53555 - Notice of Intent of Waiver With Respect to Land | |
| 82 FR 53432 - Airworthiness Criteria: Special Class Airworthiness Criteria for the FlightScan Corporation Camcopter S-100 | |
| 82 FR 53456 - Final Results of Changed Circumstances Review: Antidumping Duty Order on Carbon and Certain Alloy Steel Wire Rod From Mexico | |
| 82 FR 53473 - Countervailing Duty Investigation of Certain Hardwood Plywood Products From the People's Republic of China: Final Affirmative Determination, and Final Affirmative Critical Circumstances Determination, in Part | |
| 82 FR 53460 - Certain Hardwood Plywood Products From the People's Republic of China: Final Determination of Sales at Less Than Fair Value, and Final Affirmative Determination of Critical Circumstances, in Part | |
| 82 FR 53452 - Certain Tool Chests and Cabinets From the Socialist Republic of Vietnam: Preliminary Affirmative Determination of Sales at Less Than Fair Value, Postponement of Final Determination and Extension of Provisional Measures | |
| 82 FR 53456 - Certain Tool Chests and Cabinets From the People's Republic of China: Preliminary Affirmative Determination of Sales at Less Than Fair Value, Postponement of Final Determination, and Extension of Provisional Measures | |
| 82 FR 53493 - Combined Notice of Filings | |
| 82 FR 53552 - Presidential Declaration Amendment of a Major Disaster for the State of Texas | |
| 82 FR 53471 - Biodiesel From the Republic of Indonesia: Final Affirmative Countervailing Duty Determination | |
| 82 FR 53477 - Biodiesel From the Republic of Argentina: Final Affirmative Countervailing Duty Determination | |
| 82 FR 53496 - Combined Notice of Filings | |
| 82 FR 53481 - Fair Credit Reporting Act Disclosures | |
| 82 FR 53482 - Final Language Access Plan for the Consumer Financial Protection Bureau | |
| 82 FR 53552 - Presidential Declaration Amendment of a Major Disaster for the State of California | |
| 82 FR 53553 - Presidential Declaration of a Major Disaster for Public Assistance Only for the State of Kansas | |
| 82 FR 53479 - Ripe Olives From Spain: Postponement of Preliminary Determination in the Less-Than-Fair-Value Investigation | |
| 82 FR 53515 - Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection: Notice of Appeal of Decision Under Section 210 or 245A | |
| 82 FR 53523 - Polyethylene Terephthalate (PET) Resin From Brazil, Indonesia, Korea, Pakistan, and Taiwan; Determinations | |
| 82 FR 53433 - Best Practices for Convening a Generally Recognized as Safe Panel: Draft Guidance for Industry; Availability | |
| 82 FR 53418 - Safety Zones; Humboldt Bay Bar, Eureka, CA, Noyo River Entrance, Ft. Bragg, CA, and Crescent City Harbor Entrance Channel, Crescent City, CA | |
| 82 FR 53531 - Business and Operations Advisory Committee; Notice of Meeting | |
| 82 FR 53414 - Special Local Regulation; Mavericks Surf Competition, Half Moon Bay, CA | |
| 82 FR 53500 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
| 82 FR 53563 - Notice of Submission of Proposed Information Collection to OMB | |
| 82 FR 53558 - Mazda Motor Corporation, Receipt of Petition for Determination of Inconsequentiality of Takata's Defect Information Report Filing Under NHTSA Campaign Number 17E-034 for PSDI-5 Desiccated Driver Air Bag Inflators and Decision Denying Request for Deferral of Determination | |
| 82 FR 53508 - Bone, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments | |
| 82 FR 53505 - Assessing User Fees Under the Biosimilar User Fee Amendments of 2017; Draft Guidance for Industry; Availability | |
| 82 FR 53504 - Proposed Information Collection Activity; Comment Request | |
| 82 FR 53561 - Ford Motor Company, Receipt of Petition for Inconsequentiality and Decision Denying Request for Deferral of Determination | |
| 82 FR 53451 - Agenda and Notice of Public Meeting of the Delaware Advisory Committee | |
| 82 FR 53517 - National Park System Advisory Board; Request for Nominations | |
| 82 FR 53556 - Parts and Accessories Necessary for Safe Operation; Exemption Renewal for Ford Motor Company | |
| 82 FR 53529 - Notice of Lodging of Proposed Amendment to Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act and the Resource Conservation and Recovery Act | |
| 82 FR 53520 - Certain Wireless Audio Systems and Components Thereof; Commission Determination Not To Review an Initial Determination Granting Complainant's Motion for Leave To Amend the Complaint | |
| 82 FR 53524 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Application and Permit for Temporary Importation of Firearms and Ammunition by Nonimmigrant Aliens-ATF F 6NIA (5330.3D) | |
| 82 FR 53523 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Report of Multiple Sale or Other Disposition of Certain Rifles-ATF Form 3310.12 | |
| 82 FR 53421 - Safety Zone; Annual Fireworks Display on the Ohio River, Monongahela River, Allegheny River, Pittsburgh, PA | |
| 82 FR 53515 - Agency Information Collection Activities: Comment Request; Extension of an Information Collection | |
| 82 FR 53527 - Agency Information Collection Activities: Proposed eCollection eComments Requested; Reinstatement, With Change, of a Previously Approved Collection: 2018 Census of State and Local Law Enforcement Agencies (CSLLEA) | |
| 82 FR 53518 - Agency Information Collection Activities; Pipelines and Pipeline Rights-of-Way | |
| 82 FR 53519 - Agency Information Collection Activities; Operations in the Outer Continental Shelf for Minerals Other Than Oil, Gas, and Sulphur | |
| 82 FR 53400 - Special Conditions: General Electric Company, GE9X Engine Models; Endurance Test Special Conditions | |
| 82 FR 53531 - Notice of Permit Applications Received Under the Antarctic Conservation Act of 1978 | |
| 82 FR 53507 - Mepergan Fortis Capsules; Final Decision on Proposal To Refuse Approval of Supplemental New Drug Application; Availability of Final Decision | |
| 82 FR 53421 - Safety Zone; Atlantic Ocean, Rehoboth Beach, DE | |
| 82 FR 53501 - Proposed Data Collection Submitted for Public Comment and Recommendations | |
| 82 FR 53403 - Offer Caps in Markets Operated by Regional Transmission Organizations and Independent System Operators | |
| 82 FR 53489 - Commission Information Collection Activities (FERC-725HH); Comment Request; Revision and Extension | |
| 82 FR 53497 - Public Utility District No. 2 of Grant County; Notice of Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Protests | |
| 82 FR 53494 - City of Vernon, California; Notice of Filing | |
| 82 FR 53497 - Citizens Energy Corporation; Notice of Petition for Declaratory Order | |
| 82 FR 53488 - Elk Hills Power, LLC; Notice of Request for Waiver | |
| 82 FR 53492 - East Cheyenne Gas Storage, LLC; Notice of Application | |
| 82 FR 53490 - Combined Notice of Filings #2 | |
| 82 FR 53498 - Combined Notice of Filings #1 | |
| 82 FR 53491 - America First Hydro, LLC; Notice of Intent To File License Application, Filing of Pre-Application Document (PAD), Denying Use of the Traditional Licensing Process, Commencement of Licensing Proceeding, Scoping, and Solicitation of Study Requests and Comments on the PAD and Scoping Document | |
| 82 FR 53494 - Southern Partners, INC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 82 FR 53495 - EF Oxnard LLC, Notice of Request for Waiver | |
| 82 FR 53494 - Natural Gas Pipeline Company of America LLC; Notice of Application | |
| 82 FR 53496 - Combined Notice of Filings #1 | |
| 82 FR 53487 - Submission of Data by State Educational Agencies; Submission Dates for State Revenue and Expenditure Reports for Fiscal Year 2017, Revisions to Those Reports, and Revisions to Prior Fiscal Year Reports | |
| 82 FR 53510 - Submission for OMB Review; 30-Day Comment Request; NCI Cancer Genetics Services Directory Web-Based Application and Update Mailer (National Cancer Institute) | |
| 82 FR 53536 - Self-Regulatory Organizations; LCH SA; Notice of Filing of Proposed Rule Change, Security-Based Swap Submission, or Advance Notice Relating to Wrong Way Risk Margin | |
| 82 FR 53540 - Self-Regulatory Organizations; Cboe BYX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify Its Fees for Physical Ports | |
| 82 FR 53532 - Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify Its Fees for Physical Ports | |
| 82 FR 53549 - Self-Regulatory Organizations; Bats BYX Exchange, Inc.; Bats BZX Exchange, Inc.; Bats EDGA Exchange, Inc.; Bats EDGX Exchange, Inc.; BOX Options Exchange LLC; C2 Options Exchange, Incorporated; Chicago Board Options Exchange, Incorporated; Chicago Stock Exchange, Inc.; Financial Industry Regulatory Authority, Inc.; Investors Exchange LLC; Miami International Securities Exchange, LLC; MIAX PEARL LLC; Nasdaq BX, Inc.; Nasdaq GEMX, LLC; Nasdaq ISE, LLC; Nasdaq MRX, LLC; Nasdaq PHLX LLC; The Nasdaq Stock Market LLC; New York Stock Exchange LLC; NYSE Arca, Inc. and NYSE MKT LLC; Notice of Designation of Longer Period for Commission Action on Proceedings To Determine Whether To Approve or Disapprove Proposed Rule Changes To Establish Fees for Industry Members To Fund the Consolidated Audit Trail | |
| 82 FR 53534 - Self-Regulatory Organizations; Cboe BYX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Related to Fees for Use on Cboe BYX Exchange, Inc. | |
| 82 FR 53543 - Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rule 1059, Accommodation Transactions | |
| 82 FR 53540 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change To List and Trade Shares of the Breakwave Dry Bulk Shipping ETF Under NYSE Arca Rule 8.200-E, Commentary .02 | |
| 82 FR 53547 - Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify Its Fees for Physical Ports as They Apply to the Exchange's Equity Options Platform | |
| 82 FR 53511 - Submission for OMB Review; 30-Day Comment Request; Generic Clearance To Support the Safe To Sleep® Campaign (Eunice Kennedy Shriver National Institute of Child Health and Human Development); Correction | |
| 82 FR 53511 - Submission for OMB Review; 30-Day Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (Eunice Kennedy Shriver National Institute of Child Health and Human Development); Correction | |
| 82 FR 53512 - Prospective Grant of Exclusive Patent Commercialization License: Direct Reading Detection Kits for Surface Contamination by Antineoplastic Drugs | |
| 82 FR 53509 - Government-Owned Inventions; Availability for Licensing | |
| 82 FR 53525 - Notice Pursuant to the National Cooperative Research and Production Act Of 1993-fd.io Project, Inc. | |
| 82 FR 53527 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Node.Js Foundation | |
| 82 FR 53525 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Oregon Manufacturing Innovation Center Research and Development | |
| 82 FR 53526 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-ODVA, Inc. | |
| 82 FR 53526 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-National Armaments Consortium | |
| 82 FR 53527 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Automation and Public Safety Common Solutions Consortium | |
| 82 FR 53527 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Integrated Photonics Institute for Manufacturing Innovation Operating Under the Name of the American Institute for Manufacturing Integrated Photonics | |
| 82 FR 53532 - Product Change-Priority Mail Negotiated Service Agreement | |
| 82 FR 53510 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings | |
| 82 FR 53512 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting | |
| 82 FR 53513 - National Eye Institute; Notice of Closed Meeting | |
| 82 FR 53511 - Center for Scientific Review; Notice of Closed Meetings | |
| 82 FR 53525 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-The Open Group, L.L.C. | |
| 82 FR 53521 - Global Digital Trade 2: The Business-to-Business Market, Key Foreign Trade Restrictions, and U.S. Competitiveness; and Global Digital Trade 3: The Business-to-Consumer Market, Key Foreign Trade Restrictions, and U.S. Competitiveness; Proposed Information Collection; Comment Request; Global Digital Trade Questionnaire | |
| 82 FR 53553 - Surrender of License of Small Business Investment Company | |
| 82 FR 53538 - Submission for OMB Review; Comment Request | |
| 82 FR 53539 - Submission for OMB Review; Comment Request | |
| 82 FR 53542 - Submission for OMB Review; Comment Request | |
| 82 FR 53545 - Submission for OMB Review; Comment Request | |
| 82 FR 53537 - Proposed Collection; Comment Request | |
| 82 FR 53551 - Proposed Collection; Comment Request | |
| 82 FR 53546 - Submission for OMB Review; Comment Request | |
| 82 FR 53499 - Filing Dates for the Pennsylvania Special Election in the 18th Congressional District | |
| 82 FR 53552 - Surrender of License of Small Business Investment Company | |
| 82 FR 53552 - National Women's Business Council; Quarterly Public Meeting | |
| 82 FR 53450 - Notice of Request for Renewal and Revision of the Currently Approved Information Collection | |
| 82 FR 53500 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
| 82 FR 53411 - Kentucky Regulatory Program | |
| 82 FR 53397 - Oranges, Grapefruit, Tangerines, and Pummelos Grown in Florida; Change in Size Requirements for Oranges | |
| 82 FR 54232 - Air Quality Designations for the 2015 Ozone National Ambient Air Quality Standards (NAAQS) | |
| 82 FR 53568 - Medicare Program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year | |
| 82 FR 53531 - Membership of National Science Foundation's Senior Executive Service Performance Review Board | |
| 82 FR 53531 - Membership of the National Science Foundation's Office of Inspector Generals Senior Executive Service Performance Review Board |
Agricultural Marketing Service
Federal Crop Insurance Corporation
International Trade Administration
National Oceanic and Atmospheric Administration
Engineers Corps
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Children and Families Administration
Food and Drug Administration
National Institutes of Health
Coast Guard
Federal Emergency Management Agency
U.S. Citizenship and Immigration Services
U.S. Immigration and Customs Enforcement
Bureau of Safety and Environmental Enforcement
Indian Affairs Bureau
National Park Service
Surface Mining Reclamation and Enforcement Office
Alcohol, Tobacco, Firearms, and Explosives Bureau
Antitrust Division
Federal Aviation Administration
Federal Motor Carrier Safety Administration
National Highway Traffic Safety Administration
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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Agricultural Marketing Service, USDA.
Interim rule with request for comments.
This rule implements a recommendation from the Citrus Administrative Committee (Committee) to relax the minimum size requirements currently prescribed under the marketing Order for oranges, grapefruit, tangerines, and pummelos grown in Florida (Order). The Committee locally administers the order and is comprised of growers and handlers operating within the production area and one public member. This rule relaxes the minimum size requirements for oranges from 2
Effective November 17, 2017; comments received by January 16, 2018 will be considered prior to issuance of a final rule.
Interested persons are invited to submit written comments concerning this rule. Comments must be sent to the Docket Clerk, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Fax: (202) 720-8938; or Internet:
Abigail Campos, Marketing Specialist, or Christian D. Nissen, Regional Director, Southeast Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (863) 324-3375, Fax: (863) 291-8614, or Email:
Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email:
This rule is issued under Marketing Order No. 905, as amended (7 CFR part 905), regulating the handling of oranges, grapefruit, tangerines, and pummelos grown in Florida, hereinafter referred to as the “Order.” The Order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”
The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Orders 13563 and 13175. This rule falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this rule does not meet the definition of a significant regulatory action it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).
This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
This rule relaxes the minimum size requirements for oranges prescribed under the Order. This rule relaxes the minimum size requirements for oranges from 2
Section 905.52 of the Order provides authority to establish minimum size requirements for Florida citrus. Section 905.306 of the rules and regulation issued under the Order specifies, in part, the minimum size requirements for oranges. Requirements for domestic shipments are specified in § 905.306 in Table I of paragraph (a) and export shipments in Table II of paragraph (b).
At its June 29, 2017, meeting, the Committee discussed the continuing decline in production as a result of losses from citrus greening, which is affecting the entire production area. The Committee also recognized that some consumers are now showing a preference for smaller-sized fruit. The Committee agreed the current minimum
The Committee met again on September 28, 2017, to discuss the additional damage Hurricane Irma caused to the current crop and revisited the discussion regarding the need to reduce the minimum size requirements. The major orange-growing regions in Florida suffered significant damage and fruit loss from the hurricane. The strong winds from the storm blew substantial volumes of fruit off the trees. The impact of the storm is also expected to produce a much higher than normal fruit drop. The extent of the loss is evident in the official USDA crop estimate for this season, which reflects a 21 percent decrease from last year's estimate. Further, as the industry continues to assess the damage caused by the storm, fruit loss estimates may go even higher. Given the limited supply of fruit due to greening and the impact of Hurricane Irma, the Committee believes relaxing the size requirements for oranges is needed to make more fruit available for shipment.
Committee members recognized that with the special circumstances surrounding this season, and with the ongoing impacts of citrus greening, some allowances should be made to assist growers and handlers and provide additional volume to the market. The Committee believes relaxing the size requirements will make more fruit available to meet market demand, help maximize fresh shipments, increase returns to growers and handlers, and help address the losses stemming from the hurricane. Consequently, the Committee recommended changing the minimum size requirements for oranges from 2
The Committee also recommended a relaxation in the minimum size requirements for grapefruit covered under the Order. That change is being considered under a separate action.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.
There are approximately 20 handlers of Florida citrus who are subject to regulation under the Order and approximately 500 citrus producers in the regulated area. Small agricultural service firms are defined by the Small Business Administration (SBA) as those having annual receipts of less than $7,500,000, and small agricultural producers are defined as those having annual receipts of less than $750,000 (13 CFR 121.201).
According to data from the National Agricultural Statistics Service (NASS), the industry, and the Committee, the average f.o.b. price for Florida oranges during the 2016-17 season was $31.90 per box, and total fresh orange shipments were approximately 2.1 million boxes. Using the average f.o.b. price and shipment data, the majority of Florida orange handlers could be considered small businesses under SBA's definition ($31.90 times 2.1 million boxes equals $66.99 million divided by 20 handlers equals $3,349,500 per handler). In addition, based on the NASS data, the average grower price for the 2016-2017 season was $17.51 per box. Based on grower price, shipment data, and the total number of Florida citrus growers, the average annual grower revenue is below $750,000 ($17.51 times 2.1 million boxes equals $36,771,000 divided by 500 growers equals $73,542 per grower). Thus, the majority of handlers and producers of oranges may be classified as small entities.
This rule relaxes the minimum size requirements for oranges covered under the Order from 2
This action is not expected to increase the costs associated with the Order's requirements. Rather, it is anticipated this action will have a beneficial impact. Reducing the size requirements will make additional fruit available for shipment to the fresh market, provide an outlet for fruit that may otherwise go unharvested, and afford more opportunity to meet consumer demand. This change will provide additional fruit to fill the shortage caused by citrus greening and by Hurricane Irma. Further, by maximizing shipments, this action will help provide additional returns to growers and handlers as they work to recover from the losses stemming from the hurricane.
This action may also help reduce harvesting costs. By reducing the minimum size, more fruit will be able to be harvested immediately. This may eliminate the need to leave fruit on the tree to increase in size, which requires follow-up picking later in the season. Given the amount of fruit loss, this could help reduce picking costs substantially. The benefits of this rule are expected to be equally available to all fresh orange growers and handlers, regardless of their size.
An alternative to this action would be to maintain the current minimum requirements for domestic shipments of oranges. However, leaving the requirements unchanged would not make additional of fruit available for shipment. Following the significant damage experienced by the industry from the September 2017 hurricane, maximizing shipments will help provide additional returns to growers and handlers as they recover from the loss. Another alternative considered was to reduce the minimum maturity requirements. However, Committee members thought it was important to maintain the maturity requirements to ensure overall quality. Therefore, this alternative was rejected.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0189, Generic Fruit Crops. No changes in those requirements as a result of this action are necessary. Should any changes become necessary, they would be submitted to OMB for approval.
This rule will not impose any additional reporting or recordkeeping requirements on either small or large orange handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.
AMS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.
In addition, USDA has not identified any relevant Federal rules that
Further, the Committee's meetings were widely publicized throughout the Florida citrus industry and all interested persons were invited to attend the meetings and participate in Committee deliberations. Like all Committee meetings, the June 29, 2017, and September 28, 2017, meetings were public meetings and all entities, both large and small, were able to express their views on this issue. Finally, interested persons are invited to submit comments on this interim rule, including the regulatory and informational impacts of this action on small businesses.
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
This rule invites comments on the change to the size requirements for oranges currently prescribed under the Marketing Order for oranges, grapefruit, tangerines, and pummelos grown in Florida. Any comments received will be considered prior to finalization of this rule.
After consideration of all relevant material presented, including the Committee's recommendation, and other information, it is found that this interim rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.
Pursuant to 5 U.S.C. 553, it is also found and determined upon good cause that it is impracticable, unnecessary, and contrary to the public interest to give preliminary notice prior to putting this rule into effect and that good cause exists for not postponing the effective date of this rule until 30 days after publication in the
Grapefruit, Marketing agreements, Oranges, Reporting and recordkeeping requirements, Tangelos, Tangerines.
For the reasons set forth in the preamble, 7 CFR part 905 is amended as follows:
7 U.S.C. 601-604.
(a) * * *
(b) * * *
Federal Aviation Administration (FAA), DOT.
Final special conditions.
These special conditions are issued for the General Electric Company turbofan engine models GE9X-105B1A, -105B1A1, -105B1A2, -105B1A3, -102B1A, -102B1A1, -102B1A2, -102B1A3, and -93B1A. In these special conditions, the engine models will be referred to as “GE9X.” The engines will have novel or unusual design features associated with the engine design. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for these design features. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Effective December 18, 2017.
Diane Cook, AIR-6A1, Engine and Propeller Standards Branch, Aircraft Certification Service, 1200 District Avenue, Burlington, Massachusetts 01803-5213; telephone (781) 238-7111; facsimile (781) 238-7199; email
On January 29, 2016, General Electric Company (GE) applied for a type certificate for their new GE9X turbofan engine models. The GE9X engine models are high-bypass-ratio engines that incorporate novel or unusual design features. The GE9X engine models incorporate new technologies such that the company cannot run the endurance test conditions prescribed in § 33.87 without significant modifications making the test vehicle non-representative of the type design.
An alternative endurance test cycle has been developed that provides a level of safety equivalent with that intended by § 33.87. The alternate endurance test provides the test conditions that allow the engine to be run in type design configuration and demonstrate engine operability and durability as well as systems functionality to a level intended by the current § 33.87 rule.
These special conditions provide the necessary conditions for verification of engine-level and component-level effects as intended by the current § 33.87 Endurance test. The test is run in engine type design configuration, with only limited test enabling modifications as needed. The special conditions include a demonstration for the oil, fuel, air bleed, and accessory drive systems as required in the current § 33.87 Endurance test.
The equivalent level of severity intended by the § 33.87 Endurance test is provided by an engine test demonstration at the gas path limiting temperature and at shaft speed redlines and at the most extreme shaft speeds as determined through a critical point analysis (CPA). In addition, times on condition and cycle counts were developed to allow additional challenges to the novel or unusual
The level of durability is equivalent with that intended by the rule, which considers the damage accumulated during the test for the limiting damage mechanisms for components and engine systems, up to and including the applicable limitations declared in the Type Certificate Data Sheets (TCDS). The alternate test schedule provides conditions in the engine for a sufficient amount of time to demonstrate that no potential safety issue will develop from the limiting damage mechanisms while operating in service.
The special conditions for §§ 33.4 and 33.29 are added to support an equivalent compliance by means of mandatory inspections prescribed in paragraph (b)(3) of the § 33.87 special conditions. These special condition requirements maintain a level of safety equivalent to the level intended by the applicable airworthiness standards in effect on the date of application.
Under the provisions of Title 14, Code of Federal Regulations (14 CFR) 21.17, GE must show that the GE9X engine models meet the applicable provisions of part 33, as amended by Amendments 33-1 through 33-34. The FAA has determined that the applicable airworthiness regulations in part 33 do not contain adequate or appropriate safety standards for the GE9X engine models because of their novel or unusual engine design features. Therefore, these special conditions are prescribed under the provisions of 14 CFR 11.19 and 21.16, and will become part of the type certification basis for GE9X engine models in accordance with § 21.17(a)(2).
The GE9X engine models will incorporate the following novel or unusual design features: Technological advances that reduce noise and emissions while improving fuel efficiency and increasing thrust, when compared to previous similarly certificated GE engine models. The technological advances are incorporated into hardware design, materials, and engine operating characteristics. Introduction of complex cooling systems and film-cooled components cause metal temperatures to be significantly influenced by cooling air temperatures and air flows and are no longer in direct proportion to the gas path temperature which is a target of the current endurance test. Introduction of new materials, new design features, and operating conditions also introduced new failure modes that are not targeted by the current endurance test cycle. Some of the technological advancements were introduced in prior GE engine models and mitigated by modifications to the test engine.
For past certifications, GE has shown that the engine design, as modified, still represented the durability and operating characteristics of the intended type design but the modifications needed to the GE9X engine model to run the § 33.87 Endurance test cannot be reconciled and would affect the test outcome.
Notice of proposed special conditions No. 33-17-02-SC for the GE9X engine models was published in the
As discussed above, the special conditions are applicable to the GE9X engine model(s). Should GE apply at a later date for a change to the type certificate to include another model on the same type certificate incorporating the same novel or unusual design feature, the special conditions would apply to that model as well.
This action affects only certain novel or unusual design features on the GE9X turbofan engine models. It is not a rule of general applicability and applies only to GE, who requested FAA approval of this engine feature.
Aircraft, Engines, Aviation safety, Reporting and recordkeeping requirements.
The authority citation for these special conditions is as follows:
49 U.S.C. 106(g), 40113, 44701, 44702, 44704.
The Airworthiness Limitations section must prescribe the mandatory post-flight inspections and maintenance actions associated with any exceedance required by the endurance test, paragraph (b)(3), of these special conditions.
The engine must have means, or provisions for means, to automatically record and alert maintenance personnel of each occurrence of any exceedance required by the endurance test paragraph (b)(3), of these special conditions.
(a)
(1) Conduct the tests in paragraphs (b), (c), and (d) of these special conditions, for total cumulative and dwell time duration between ground idle and the takeoff thrust prescribed in these special conditions. The test cycle durations must include all maximums allowed in the TCDS and expected service operation.
(2) Requirements of § 33.87(a)(1), (2), (4), and (6).
(3) Requirements of § 33.87(a)(3) applicable to the temperature of external surfaces of the engine.
(4) Testing for maximum air bleed must be at least equal with the prescribed test required in § 33.87(a)(5). However, for these cycles, the thrust or the rotor shaft rotational speed may be less than 100 percent of the value associated with the particular operation being tested if the FAA finds that the validity of the endurance test is not compromised.
(5) Testing for engine fuel, oil, and hydraulic fluid pressure and oil temperature must be at least equal with the prescribed test required in § 33.87(a)(7).
(6) If the number of occurrences of either transient rotor shaft overspeed or transient gas over temperature is not limited, at least 155 accelerations must be made at the limiting overspeed or over temperature. If the number of occurrences is limited, that number of accelerations must be made at the limiting overspeed or over temperature.
(7) One hundred starts must be made, of which:
(i) Twenty-five starts must be preceded by at least a two-hour engine shutdown.
(ii) Ten false engine starts must be accomplished, pausing for the applicant's specified minimum fuel drainage time, before attempting a normal start.
(iii) Ten normal restarts must be accomplished with not longer than 15 minutes since engine shutdown.
The remaining starts may be made after completing the endurance testing prescribed by these special conditions.
(8) Unless otherwise specified (
(i) When operating with max oil temperatures the throttle movement may be `stair-stepped' to allow for oil temperature stabilization for durations greater than two seconds.
(9) The applicant must validate any analytical methods used for compliance with these special conditions. Validation includes the ability to accurately predict an outcome applicable to the engine being tested.
(10) The applicant must perform the endurance test on an engine that substantially conforms to its type design. Modifications may be made as needed to achieve test conditions and/or engine operating conditions representative of the type design.
(b) Conduct the endurance test at or above the declared shaft speeds and gas temperatures limits, and at or above conditions representative of critical points (speeds, temperatures, rated thrust) in the operating envelope.
(1) Conduct the endurance test at or above the rated takeoff thrust and rated maximum continuous thrust and with the associated limits for rotor speeds and gas temperature (redlines), as follows:
(i) Either rotor speed or gas temperature, or concurrent rotor speed and gas temperature, if analysis indicates a combination of redline operational conditions is possible to occur in service, must be at least 100 percent of the values associated with the engine rating being tested.
(ii) The cumulative test time duration and number of cycles must be representative of the rotor speed and gas temperature excursions to redlines that can be expected to occur in between overhauls.
(iii) The time durations for each takeoff or maximum continuous segment must include all maximums allowed in the TCDS and expected service operation and must include the following cycles:
(A) At least one (1) takeoff cycle of 5-minutes time duration at the low pressure rotor speed limit and gas temperature limit (redlines).
(B) At least one (1) takeoff cycle of 5-minutes time duration at the high pressure rotor speed limit and gas temperature limit (redlines).
(C) In lieu of the separate cycles specified in paragraphs (A) and (B) of this section, the applicant may run the low pressure and high pressure rotor speeds and gas temperature limits (redlines) in the same cycle. However, in this case, the applicant must run at least 2 cycles of 5 minutes' time duration each.
(2) Conduct the endurance test at or above the rated takeoff thrust and the rated maximum continuous thrust with rotor speeds at or above those determined by a critical point analysis (CPA) and with gas temperature redline conditions as follows:
(i) The applicant must determine through a CPA the highest rotor shaft rotational speeds (CPA speeds) expected to occur for each rotor shaft system within the declared operating envelope. The CPA must be conducted for the takeoff and maximum continuous rated thrust and must consider the declared operating envelope, engine deterioration, engine-to-engine variability, and any other applicable variables that can cause the engine to operate at the extremes of its performance ratings.
(ii) Except as provided in paragraph (b)(3)(ii) of these special conditions, conduct a cyclic test between ground idle and combined takeoff and maximum continuous thrust ratings, as follows:
(A) Eighteen hours and forty-five minutes (18.75 hours) cumulated time duration at or above the rated takeoff thrust, the gas temperature limit for takeoff (redline), and the CPA rotor speeds for takeoff determined per paragraph (b)(2)(i) of these special conditions.
(B) Forty-five (45) hours cumulated time duration at or above the rated maximum continuous thrust, the gas temperature limit for maximum continuous (redline), and the CPA rotor speeds for maximum continuous determined per paragraph (b)(2)(i) of these special conditions.
(C) The time durations for each takeoff or maximum continuous segments must include all maximums allowed in the TCDS and expected service operation, and must include at least one maximum continuous cycle of 30 minutes run continuously.
(3) If the cyclic shaft speed excursions specified in paragraphs (b)(1) or (b)(2) of these special conditions cannot be demonstrated in the test, then an alternative equivalent with the rule intent must be provided. Alternatives may include alternate means of test demonstration, mandatory actions, or other means found acceptable to the FAA. The applicant must prescribe a mandatory action plan for engine operation between the shaft speeds demonstrated for a minimum of cumulated 18.75 hours at or above rated takeoff and 45 hours at or above rated maximum continuous, respectively, and the declared speed limits (redlines), as follows:
(i) Prescribe post-event actions or operating limitations acceptable to the FAA for operation below the declared speed limits (redlines) and above the CPA speeds.
(ii) If the test required by (b)(2)(ii) of these special conditions can only be accomplished at a rotor shaft speed lower than the CPA speed, prescribe post-event actions or operating limitations acceptable to the FAA for operation below that CPA speed and above the value demonstrated during the test.
(c) Conduct the endurance test at the incremental cruise thrust that must be at least equal with the prescribed test required in § 33.87(b)(4). The 25 incremental test cycles must be uniformly distributed throughout the entire endurance test.
(d) Conduct at least 300 cycles between ground idle and combined rated takeoff and rated maximum continuous thrust, as follows:
(1) Each cycle to include acceleration to or above rated takeoff thrust, deceleration from takeoff to ground idle, followed by 5 to 15 seconds at ground idle, acceleration to or above rated
(2) The throttle movement from ground idle to rated takeoff or maximum continuous thrust and from rated takeoff thrust to ground idle should be not more than one (1) second, except that, if different regimes of control operations are incorporated necessitating scheduling of the thrust-control lever motion in going from one extreme position to the other, a longer period of time is acceptable, but not more than two (2) seconds. The throttle movement from rated maximum continuous thrust to ground idle should not be more than five (5) seconds.
(3) The time durations for each cycle associated with either takeoff or maximum continuous thrust segments must include all maximums allowed in the TCDS and expected service operation, and must include the following cycles:
(i) Three (3) cycles of 5 minutes each and one (1) cycle of 10 minutes at the takeoff thrust.
(ii) Three (3) cycles of 30 minutes each at the maximum continuous thrust.
Federal Energy Regulatory Commission, Department of Energy.
Order on rehearing and clarification.
The Federal Energy Regulatory Commission is granting in part and denying in part requests for rehearing and clarification of its determinations in Order No. 831, which amended its regulations to address incremental energy offer caps in markets operated by regional transmission organizations and independent system operators.
This rule is effective January 16, 2018.
1. On November 17, 2016, the Federal Energy Regulatory Commission (Commission) issued Order No. 831.
2. In Order No. 831, the Commission amended its regulations to require that each regional transmission organization and independent system operator (RTO/ISO): (1) Cap each resource's incremental energy offer at the higher of $1,000/MWh or that resource's verified cost-based incremental energy offer; and (2) cap verified cost-based incremental energy offers at $2,000/MWh when calculating LMPs (hard cap).
3. With respect to treatment of cost-based incremental energy offers above $2,000/MWh, the Commission stated that it expects RTOs/ISOs to use such offers to determine merit-order dispatch, and it cited PJM as an example of an RTO/ISO that uses cost-based incremental energy offers above $2,000/MWh to determine merit-order dispatch, but limits cost-based incremental energy offers to $2,000/MWh for purposes of calculating LMP.
4. On December 19, 2016, the Commission received four requests for rehearing and/or clarification of Order No. 831 which raise issues related to the structure of the offer cap, the verification requirement, and the costs included in cost-based incremental energy offers. TAPS filed a request for rehearing and clarification. NYISO filed a request for clarification and, alternatively, request for rehearing. AMP/APPA filed a request for rehearing. Exelon filed a motion for clarification and request for rehearing.
5. The requests for rehearing and clarification regarding the offer cap structure focus on the level of the hard cap and the implementation of the hard cap.
6. TAPS seeks rehearing and argues both that the $2,000/MWh hard cap level established by the Commission is not supported by substantial evidence, and that the $1,724/MWh offer cited in Order No. 831 was not a legitimate cost-based incremental energy offer.
7. We deny TAPS' request for rehearing of the $2,000/MWh level of the hard cap. In Order No. 831, the Commission determined that a hard cap was necessary to limit any adverse impact on LMPs due to imperfect information about a resource's short-run marginal costs that might arise during the verification process.
8. The overall offer cap structure set forth in Order No. 831 and the overall market structure of RTOs/ISOs in which the offers arise affected the balance struck by the Commission in setting the level of the hard cap. The hard cap does not stand alone, meaning that it is not the only way of ensuring that an offer does not reflect the exercise of market power and that the price resulting from an incremental energy offer is just and reasonable. In balancing the competing goals, the Commission effectively recognized that the hard cap serves as a backstop to the mitigation established through both the cost-based requirement and the verification process—the other elements of the offer cap structure. The cost-based offer requirement serves a “mitigation function”
9. In setting that level, the Commission also considered the overall market structure of RTOs/ISOs—a structure designed to ensure that markets are competitive and not subject to the exercise of market power, through for instance, existing market power mitigation processes.
10. Based on the record, the Commission set the level of the hard cap to $2,000/MWh. The Commission determined that $2,000/MWh was the level that short-run marginal costs would rarely exceed.
11. The alternative $1,500/MWh and $1,800/MWh hard cap levels that TAPS proposed would result in a balance different than the one chosen by the Commission. Lower hard cap levels such as these would increase the likelihood of suppressing prices below the marginal cost of production and would thereby run contrary to the Commission's price formation efforts to ensure that LMPs reflect the short-run marginal cost of the marginal resource. We therefore reject TAPS' request for rehearing and the alternative hard cap levels proposed. As stated above, we continue to find that the $2,000/MWh hard cap reasonably balances reducing the likelihood of suppressing LMPs while limiting any adverse impact on LMPs from imperfect information about resources' short-run marginal costs during the verification process.
12. Further, we reject TAPS' argument that the Commission failed to meaningfully address its $1,500/MWh alternative proposal. The Commission addressed this alternative in adopting the $2,000/MWh hard cap.
13. NYISO seeks clarification that Order No. 831 does not require that incremental energy offers above $2,000/MWh be used to determine merit-order dispatch in all RTOs/ISOs, and, in the alternative, seeks rehearing on this issue.
14. NYISO asserts that such a requirement would introduce foreign market design elements into NYISO that were developed by PJM to be compatible with its own pricing method, market rules, and software.
15. In addition, NYISO requests clarification that RTOs/ISOs are permitted to apply the same offer cap to both incremental energy and minimum generation offers,
16. Regarding NYISO's concerns on economic merit-order dispatch, we clarify that Order No. 831 did not require cost-based incremental energy offers above $2,000/MWh to be used to determine economic merit-order dispatch. We recognize that some RTO's/ISO's existing commitment, dispatch, and pricing algorithms are structured differently, and the Commission in Order No. 831 did not require RTOs/ISOs to change their current practices or software to use cost-based incremental energy offers above $2,000/MWh for determining economic merit-order dispatch. However, in the event that RTOs/ISOs must select from several offers above $2,000/MWh, we encourage RTOs/ISOs to make those selections on a least-cost basis when possible, in order to minimize the cost to serve load.
17. We also clarify that application of the offer cap and verification requirement adopted in Order No. 831 to minimum generation offers, as NYISO requests, is appropriate. Applying different offer caps to minimum generation and incremental energy offers could give resources the incentive to shape their offers in a manner that does not reflect their costs.
18. The requests for rehearing regarding the verification requirement focus on the use of expected costs in the verification requirement and whether to subject imports to the verification requirement.
19. The requests for rehearing regarding expected costs include the definition of expected costs and whether they should be included in the regulatory text as well as market power concerns related to the use of expected costs in the verification process.
20. AMP/APPA seek rehearing of Order No. 831, arguing that the Commission was arbitrary and capricious because it failed to provide a reasonable justification for allowing sellers' expected costs to set LMP, and that the Commission also unjustifiably expanded the definition of cost-based offers to include “expected” costs. According to AMP/APPA, in order for LMPs to send accurate signals regarding the actual cost of producing energy, LMPs should be based on actual costs. AMP/APPA argue that, since some commenters stated that pre-verification of actual costs would not be possible, the Commission should have concluded that offers above $1,000/MWh should not set LMP, and instead, required such costs to be recovered via uplift.
21. Exelon requests rehearing of the fact that the regulatory text does not include the “actual or expected” phrase when it describes the costs to be verified. Exelon argues that the current regulatory text fails to adequately capture the Commission's intent described in the preamble, specifically that costs may be either actual or expected. Exelon asserts that, in order to avoid confusion and also satisfy due process and regulatory notice requirements, the Commission should amend the regulatory text to specify that the verified costs can be “actual or expected.”
22. We disagree with AMP/APPA's argument that the use of expected costs in the verification process to set LMPs was arbitrary and capricious, and thus deny its request for rehearing. The record demonstrates that certain natural gas resources do not know their actual short-run marginal costs at the time they submit their incremental energy offers, and thus it is just and reasonable, and consistent with current practice, for such resources to offer based on their expected costs.
23. We grant Exelon's request to amend the regulatory text by adding the words “actual or expected” as suggested by Exelon. We agree that these revisions will provide more certainty to market participants and more clearly state the Commission's intention that both actual and expected costs over $1,000/MWh may be submitted for verification.
24. AMP/APPA seek rehearing contending that Order No. 831 is arbitrary and capricious because it fails to address market power concerns that may arise if resources exaggerate expected costs included in cost-based incremental energy offers above $1,000/MWh.
25. AMP/APPA further assert that Order No. 831 failed to address whether
26. AMP/APPA seek rehearing of Order No. 831, arguing that the Commission's use of expected costs in setting LMP was arbitrary and capricious, and that the Commission did not explain its departure from relevant precedent.
27. We deny AMP/APPA's request for rehearing and alternative proposal regarding market power concerns and the use of expected costs. We disagree with AMP/APPA that incremental energy offers above $1,000/MWh based on expected costs present market power concerns; the verification requirement in Order No. 831 was specifically designed to address market power concerns and ensure that all incremental energy offers above $1,000/MWh are indeed cost-based. Pursuant to the verification requirement, resources may only submit incremental energy offers above $1,000/MWh if they are cost-based, and the RTO/ISO or Market Monitoring Unit must verify that any such offer reasonably reflects that resource's actual or expected short-run marginal costs. Incremental energy offers above $1,000/MWh may not be used to calculate LMPs if such offers cannot be verified by the RTO/ISO or Market Monitoring Unit prior to the market clearing process. In Order No. 831, the Commission specifically found that “the verification requirement reasonably addresses market power concerns associated with incremental energy offers above $1,000/MWh because such offers will be required to be cost-based, which should deter attempts by resources to exercise market power.”
28. We reject as unsupported AMP/APPA's claim that the Final Rule did not address concerns about market power in the natural gas market. The excerpts from the PJM Market Monitor's and ISO-NE Market Monitor's comments that AMP/APPA included in its request for rehearing expressed general concern about removing a hard cap in energy markets given potential concerns about market power in natural gas markets. However, Order No. 831 did not remove a hard cap in energy markets—it adopted a $2,000/MWh hard cap. As discussed above, we balanced several considerations in adopting a $2,000/MWh but the fact that a hard cap continues to remain in place addresses the comments AMP/APPA cites, to the extent there is market power in the natural gas markets. Additionally, the excerpt from the ISO-NE Market Monitor's comments cited by AMP/APPA discusses the relationship between natural gas markets and energy markets and expresses general concerns about limited transparency into the competitive conditions in natural gas spot markets. Again, the $2,000/MWh hard cap addresses this concern as it recognizes that the verification process required by Order No. 831 may be less effective during extreme conditions in the natural gas market.
29. We deny AMP/APPA's request for rehearing regarding market-based rates because Order No. 831 does not depart from Commission precedent, and the Commission's action was not arbitrary and capricious. Contrary to AMP/APPA's claims, a market participant with market-based rate authority that submits a cost-based incremental offer above $1,000/MWh for a resource would continue to be subject to the existing reporting and other requirements that are imposed on entities with market-based rate authority,
30. TAPS seeks rehearing of Order No. 831's exemption of all imports from the verification requirement for incremental energy offers above $1,000/MWh and asserts that it is unjust and unreasonable and arbitrary, and that it puts internal and external resources on unequal footing.
31. We deny TAPS' request for rehearing regarding the treatment of imports. In Order No. 831, the Commission found that exempting incremental energy offers from imports above $1,000/MWh from the verification requirement was justified because imports are not similarly situated to internal resources.
32. With respect to TAPS' proposed alternative which would prevent import offers above $1,000/MWh from setting LMP if the costs cannot be verified, we reject it because, as supported in the record,
33. In Order No. 831, the Commission also considered market power concerns similar to those raised by TAPS in its rehearing request, but did not find that they warranted requiring cost-verification for import offers above $1,000/MWh. The Commission explained that because “market participants can import energy from adjacent markets and sell that energy in the RTO/ISO energy market . . . it is difficult for external resources in an adjacent market to withhold.”
34. Exelon requests clarification, and alternatively rehearing, that the Commission did not intend to exclude any particular categories of variable costs, particularly those not tied to the price of the commodity associated with the resource's fuel supply. Exelon asserts that a resource's cost-based incremental energy offer is comprised not only of those costs linked to the price of fuel, but also of other variable costs, including but not limited to balancing costs and transportation costs. Exelon states that if the Commission does not grant its requested clarification, then it seeks rehearing on the basis that exclusion of other variable costs from cost-based incremental energy offers would lead to an unjust and unreasonable result.
35. TAPS requests clarification, and alternatively rehearing, regarding whether opportunity costs may be recovered in addition to the $100/MWh adder.
36. NYISO requests that the Commission clarify that, when calculating uplift payments for the recovery of verified costs, only actual, documented out-of-pocket costs should be paid after-the-fact and that no risk-related adders or opportunity costs be allowed when cost information is not submitted in a sufficiently timely manner to permit review and verification. NYISO states that it is concerned that the submission of legitimate, verifiable costs that exceed the $1,000/MWh offer cap close in time to the day-ahead or real-time market close could deny NYISO sufficient time to perform cost verification. NYISO states that this could cause the resource's offer to be mitigated to a level that does not include the unverified, additional costs and could cause the resource to be committed when it would not have otherwise been or receive a larger schedule than it otherwise would have. NYISO asserts that its requested clarification would ensure all resources have an incentive to submit timely information to the RTO/ISO.
37. We deny Exelon's request for clarification, and alternatively rehearing, regarding whether the verification requirement intended to exclude particular categories of actual or expected costs, particularly variable costs that are non-fuel related costs. In Order No. 831, the Commission neither required RTOs/ISOs to change the methodologies they currently use to develop cost-based offers in order to satisfy the verification requirement nor prescribed the specific types of short-run marginal costs that could be included in cost-based incremental energy offers above $1,000/MWh. We do not prejudge what types of costs RTOs/ISOs may propose as part of their compliance filings.
38. We deny TAPS' request for clarification, and alternatively rehearing, regarding whether the $100/MWh limit on adders applies to opportunity costs. Opportunity costs are legitimate short-run marginal costs and not adders above cost. Cost-based incremental energy offers based on opportunity costs may currently set LMP in many RTOs/ISOs. Given that, in Order No. 831, the Commission did not require RTOs/ISOs to change the specific costs that they permit resources to include in cost-based incremental energy offers, resources in RTOs/ISOs that permit the use of opportunity costs in this manner may continue to do so after implementing Order No. 831. Because opportunity costs should be considered part of a cost-based incremental energy offer, whether or not the offer exceeds $1,000/MWh, verifiable opportunity costs should not be subject to the $100/MWh limit on adders above cost. We do not prejudge the validity of including verifiable opportunity costs in cost-based incremental offers above $1,000/MWh or the verification methods of such costs that RTOs/ISOs may propose as part of their compliance filings. We also reject TAPS' argument that the Commission failed to meaningfully address its arguments stating that opportunity costs should not be permitted at the “extreme” prices contemplated in this rulemaking.
39. We grant NYISO's request for clarification regarding the calculation of uplift payments. Resources are only eligible to receive uplift payments to make them whole to, at most, their submitted cost-based incremental energy offers if the associated offer and cost information is submitted in a sufficiently timely manner and verified by the RTO/ISO, meaning offers and supporting information must be provided consistent with RTO/ISO offer submission guidelines and approved by the RTO/ISO or Market Monitoring Unit. Consistent with Order No. 831, the after-the-fact uplift payment that a resource would be eligible to receive if its cost-based incremental energy offer above $1,000/MWh is not verified prior to market clearing shall include only actual verifiable costs. We agree with NYISO that opportunity costs, like other costs, must be submitted in a timely manner. However, we clarify that if a resource avails itself of an RTO's/ISO's current rules to allow a resource to include opportunity costs in its cost-based incremental energy offer, then that RTO/ISO must give that resource an
40. Further, such after-the-fact uplift payments may not include any adders above cost, including risk related adders, because actual costs are known after-the-fact.
41. The Paperwork Reduction Act (PRA)
42. The Commission is amending its regulations to clarify what the Commission already required in Order No. 831—that either actual or expected costs included in incremental energy offers above $1,000/MWh may be submitted for verification. The Commission estimates that there will be no net change to burden.
43. Interested persons may obtain information on the reporting requirements by contacting: Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426 [Attention: Ellen Brown, Office of the Executive Director, email:
44. The Regulatory Flexibility Act of 1980 (RFA)
45. In addition to publishing the full text of this document in the
46. From FERC's Home Page on the Internet, this information is available on eLibrary. The full text of this document is available on eLibrary in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number excluding the last three digits of this document in the docket number field.
47. User assistance is available for eLibrary and the FERC's Web site during normal business hours from FERC Online Support at 202-502-6652 (toll free at 1-866-208-3676) or email at
48. These regulations are effective January 16, 2018.
Electric power rates, Electric utilities, Non-discriminatory open access transmission tariffs.
By the Commission.
In consideration of the foregoing, the Commission amends part 35, chapter I, title 18,
16 U.S.C. 791a-825r, 2601-2645; 31 U.S.C. 9701; 42 U.S.C. 7101-7352.
(g) * * *
(9) A resource's incremental energy offer must be capped at the higher of $1,000/MWh or that resource's cost-based incremental energy offer. For the purpose of calculating Locational Marginal Prices, Regional Transmission Organizations and Independent System Operators must cap cost-based incremental energy offers at $2,000/MWh. The actual or expected costs underlying a resource's cost-based incremental energy offer above $1,000/MWh must be verified before that offer can be used for purposes of calculating Locational Marginal Prices. If a resource submits an incremental energy offer above $1,000/MWh and the actual or expected costs underlying that offer cannot be verified before the market clearing process begins, that offer may not be used to calculate Locational Marginal Prices and the resource would be eligible for a make-whole payment if that resource is dispatched and the
Office of Surface Mining Reclamation and Enforcement (OSMRE), Interior.
Final rule; approval of amendment.
We are approving an amendment to the Kentucky regulatory program (hereinafter, the “Kentucky program”) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Kentucky submitted a proposed amendment to OSMRE that includes revisions to the Kentucky Revised Statutes (KRS) as authorized by House Bill 385 (HB 385), regarding bonding of surface coal mining and reclamation operations.
The effective date is December 18, 2017.
Robert Evans, Telephone: (859) 260-3900. Email:
Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its program includes, among other things, State laws and regulations that govern surface coal mining and reclamation operations in accordance with the Act and consistent with the Federal regulations. See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Kentucky program on May 18, 1982. You can find background information on the Kentucky program, including the Secretary's findings, the disposition of comments, and conditions of approval of the Kentucky program in the May 18, 1982,
On May 10, 2011, Kentucky submitted an amendment to OSMRE for approval that proposed bonding revisions to the KRS as authorized by HB 385, which passed during the State's regular 2011 legislative session. HB 385 was passed in response to OSMRE's findings in its January 5, 2011, National Priority Oversight Evaluation of the Adequacy of Kentucky Reclamation Performance Bond Amounts (National Oversight Study) report. In that report, OSMRE oversight and programmatic reviews identified that current reclamation performance bonds in Kentucky are not sufficient to complete the reclamation required in approved permits. On February 3, 2011, the Kentucky Department for Natural Resources (KYDNR) and OSMRE signed an Action Plan detailing the steps necessary for correcting identified bond calculation deficiencies. The Action Plan required KYDNR to complete revised bonding protocols by April 1, 2011, along with a timetable for implementation for new and existing permits. HB 385 amends Kentucky Revised Statutes 350.060 to provide that:
Within thirty (30) days of a cabinet determination of a need to change a bond protocol currently in use, the cabinet shall immediately promulgate administrative regulations setting forth bonding requirements including, but not limited to, requirements for the amount, duration, release, and forfeiture of bonds. Bond protocols shall not be exempt from KRS 13A.100 and shall be established by promulgating administrative regulations under KRS Chapter 13A. Failure to include the formula for establishing the amount of the bond in any administrative regulation on bonding requirements shall be deemed a failure to comply with the prescriptions of this section and the administrative regulation shall automatically be declared deficient in accordance with KRS Chapter 13A.
We announced receipt of the amendment and asked for comments in a
The following are the findings we made concerning Kentucky's proposed amendment under SMCRA at Section 509, 30 U.S.C. 1259 and the Federal regulations at 30 CFR 800.14 and 800.15.
The new language in KRS 350.060 (11) is intended to ensure that bond protocol regulations include the formula for establishing the amount of the bond. Failure to do so would result in any administrative regulations or bonding requirements to be declared deficient automatically, in accordance with KRS Chapter 13A.
While these proposed State revisions have no direct Federal counterparts there is no provision in SMCRA or its implementing regulations that prohibits a State from requiring its bond protocols to be implemented solely as regulations. On their face, the proposed revisions are not inconsistent with Section 509 of SMCRA and 30 CFR 800.14, and we are therefore approving them, as noted below.
While HB 385 could be construed to require the KYDNR to implement all bond adjustments as regulations before the adjustments can be made, to do so would be inconsistent with the literal construction of the language of the bill. Therefore, we do not construe HB 385 to apply to individual bonding adjustments, or other individual bonding decisions.
Rather, we are approving the proposed amendment, in accordance with its plain language, which will not impede implementation of the requirement in Section 509 of SMCRA that “[t]he amount of the bond shall be sufficient to assure the completion of the reclamation plan if the work had to be performed by the regulatory authority in the event of forfeiture.” Nor will the proposed amendment impede the obligation of the regulatory authority to adjust the amount of bond in accordance with 30 CFR 800.15. Should we find, however, during oversight, that the amendment is being interpreted in a manner that would render it inconsistent with either Section 509 of
Further, we are approving the proposed amendment because, in accordance with its plain language, it will not impede the regulatory authority's ability to address the current bond deficiencies identified in the National Oversight Study and the February 3, 2011, Action Plan detailing the steps necessary for correcting bond calculation deficiencies that were identified in the study. Specifically, OSMRE expects the KYDNR to ensure the adequacy of bonds on all currently issued permits through the adjustment process, and all permits issued pending the formal revision to any existing bonding protocol. Should we find, however, during oversight, that the amendment is being implemented in a manner that would impede the regulatory authority's ability to address current bond deficiencies, we will initiate proceedings under 30 CFR 730.11(a), as appropriate, to have the provisions of the amendment set forth and set aside.
Finally, we are approving the amendment with the understanding that it would not apply to bond protocols or bonding regulations in existence as of the date that HB 385 became effective. Should we find, however, during oversight, that the amendment is being interpreted in a manner that would render it applicable to bond protocols or regulations in existence as of the date that the amendment became effective, we will initiate proceedings under 30 CFR 730.11(a) to publish a notice in the
We asked for public comments on the amendment and received responses from Coal Operators & Associates, Inc. (COA) and Kentucky Resources Council (KRC).
1. COA stated that the language of our August 15, 2011,
2. COA stated that the intent of HB 385 is to prevent Kentucky from arbitrarily changing bond protocols, requirements or formulae without adequate transparency and public comment.
3. According to COA, the purpose of HB 385 is to insure that the Energy and Environment Cabinet (EEC) follows the statutory mandates that have existed since the inception of the Kentucky Permanent Regulatory Program. To accomplish that, HB 385 provides for statutory declarations of deficiency if the bonding formula is not promulgated as a KRS Ch. 13A regulation.
4. The COA stated that the KRS Ch. 13A Administrative Regulation process is one based upon public input, comment and review. Briefly, proposed regulations are not only published in the Administrative Register of Kentucky, but, EEC provides electronic notification to any interested citizen or stakeholder. Oral testimonies at public hearings, written comments that are submitted, as well as testimonies before the Administrative Regulation Review Sub-committee and the appropriate House and Senate Committees provide interested parties adequate notice and input on proposed regulations.
5. COA explained that some concern has been expressed about the length of time it takes under KRS Ch. 13A to adopt new, ordinary regulations. The Governor of the Commonwealth can issue an emergency regulation which becomes effective upon his signature. (KRS 13A.170 and 190). The ordinary regulation is filed simultaneously and proceeds through the mandatory process. Concurrently, the emergency regulation is in effect.
6. KRC stated its belief that HB 385 was sought by the Kentucky coal industry as a mechanism for delaying the adoption of changes in the bonding calculations and amounts.
7. KRC asserted that HB 385 was enacted at a time when Kentucky was in default of its ongoing, enforceable obligation under 30 CFR 733.11 to “implement, administer, enforce and maintain it in accordance with the Act, this chapter and the provisions of the approved State program.” More specifically, Kentucky was, and is, in continuing violation of mandatory obligations outlined in 30 CFR 800.4. KRC also believes that absent a commitment from Kentucky to resolve the bond amount issue, they are in default as required by 30 CFR 733.11. Therefore, KRC urged OSMRE to take steps to promptly remove State regulation approval with respect to bond calculation and adjustment for new and existing permits, and to substitute direct Federal enforcement of the requirements of 30 U.S.C. 1259, unless Kentucky revises the bond calculation protocols to assure adequate
8. KRC does not oppose the amendments on their face, since SMCRA is silent as to whether bond calculation methodologies must be implemented in regulatory form, and since requiring these methodologies to be promulgated as regulations will require OSMRE approval and public opportunity to comment. However, KRC states that OSMRE should request that the State clarify that it interprets the amendment to apply to bond calculation formulae and not to individual bond calculation decisions, or revisions thereto.
9. Next, KRC stated that OSMRE should require the State to clarify that the provision declaring deficient any bond calculation formula that is not promulgated as a regulation applies only to changes in such protocols, and not to existing protocols. KRC further stated that clarification should also be sought as to the State's interpretation of the last sentence of the amendment, since, read broadly; it could affect existing, approved bonding regulations that are a necessary component of the state regulatory program.
Under 30 CFR 732.17(h)(11)(i) and Section 503(b) of SMCRA, on August 15, 2011, we requested comments on the amendments from various Federal agencies with an actual or potential interest in the Kentucky program (Administrative Record No. KY-1665). No comments were received.
Under 30 CFR 732.17(h)(11)(ii), we are required to get a written concurrence from EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251
Based on our findings, OSMRE approves the amendment Kentucky sent to us on May 10, 2011, revising the Kentucky Revised Statues (KRS) as authorized by HB 385 regarding bonding of surface coal mining and reclamation operations.
To implement this decision, we are amending the Federal regulations at 30 CFR part 917 which codify decisions concerning the Kentucky program. In accordance with the Administrative Procedure Act, this rule will take effect 30 days after date of publication. Section 503(a) of SMCRA requires that the State's program demonstrate that the State has the capability of carrying out the provisions of the Act and meeting its purposes. SMCRA requires consistency of State and Federal standards.
This rule does not have takings implications. This determination is based on the analysis performed for the counterpart Federal regulation.
This rule is exempted from review by the Office of Management and Budget (OMB) under Executive Order 12866.
The Department of the Interior has conducted the reviews required by Section 3 of Executive Order 12988 and has determined that this rule meets the applicable standards of Subsections (a) and (b) of that section. However, these standards are not applicable to the actual language of State regulatory programs and program amendments because each program is drafted and promulgated by a specific State, not by OSMRE. Under Sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and the Federal regulations at 30 CFR 730.11, 732.15, and 732.17(h)(10), decisions on proposed State regulatory programs and program amendments submitted by the States must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing Federal regulations and whether the other requirements of 30 CFR parts 730, 731, and 732 have been met.
This rule does not have Federalism implications. SMCRA delineates the roles of the Federal and State governments with regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 503(a)(1) of SMCRA requires that State laws regulating surface coal mining and reclamation operations be “in accordance with” the requirements of SMCRA, and Section 503(a)(7) requires that State programs contain rules and regulations “consistent with” regulations issued by the Secretary pursuant to SMCRA.
In accordance with Executive Order 13175, we have evaluated the potential effects of this rule on Federally recognized Indian tribes and have determined that the rule does not have substantial direct effects 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. The basis for this determination is that our decision is on a State Regulatory program and does not involve a Federal Regulation involving Indian Lands.
Executive Order 13211 of May 18, 2001, requires agencies to prepare a Statement of Energy Effects for a rule that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use
This rule does not require an environmental impact statement because Section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that agency decisions on proposed State regulatory program provisions do not constitute major Federal actions within the meaning of Section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C)).
This rule does not contain information collection requirements that require approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3507
The Department of the Interior certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule: (a) Does not have an annual effect on the economy of $100 million; (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. This determination is based upon the fact that the Kentucky submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rule.
This rule will not impose an unfunded mandate on State, local, or tribal governments or the private sector of $100 million or more in any given year. This determination is based upon the fact that the Kentucky submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation did not impose an unfunded mandate.
Intergovernmental relations, Surface mining, Underground mining.
For the reasons set out in the preamble, 30 CFR part 917 is amended as set forth below:
30 U.S.C. 1201
(a) * * *
Coast Guard, DHS.
Final rule.
The Coast Guard is revising a special local regulation in the navigable waters of Half Moon Bay, CA, near Pillar Point in support of the Mavericks Surf Competition, an annual invitational surf competition held at the Mavericks Break. This revision is necessary to improve the regulation by making it clearer and to have it better reflect the natural conditions that must be met for this surf competition to take place. This regulation is necessary to provide for the safety of life on the navigable waters immediately prior to, during, and immediately after the surfing competition, which is held only one day between November 1 of each year and March 31 of the following year. This revision temporarily restricts vessel traffic in the vicinity of Pillar Point and prohibits vessels and persons not participating in or directly supporting the surfing event from entering the dedicated surfing area and a designated no-entry area.
This rule is effective December 18, 2017.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions about this rulemaking, call or email Lieutenant Junior Grade Christina Ramirez, U.S. Coast Guard Sector San Francisco; telephone (415) 399-2001, email at
The Mavericks Surf Competition has grown in popularity within the past several years. Due to the inherent dangers of the competition and the disruption to the normal uses of the waterways in the vicinity of Pillar Point, the Coast Guard issues a Marine Event Permit to the event sponsor. Following the collapse of the Cliffside viewing area in 2011, the Coast Guard became concerned that the loss of shore-side viewing area would result in a larger than expected number of spectator vessels in the vicinity of the event.
This final rule formalizes the scheme employed during the 2013 and 2014 competitions, which proved to be an effective means of separating competitors from spectators. The two zones and associated regulations contained in this final rule are intended to ensure the safety of competitors from spectator vessels, and enhances the safety of spectator vessels by creating a designated area in which the Coast Guard may direct the movement of such vessels. Because of the dangers posed by the surf conditions during the Mavericks Surf Competition, the special local regulation is necessary to provide for the safety of event participants, spectators, and other vessels transiting the event area. For the safety concerns noted, it is in the public interest to have these regulations in effect during the event.
On October 15, 2014, the Coast Guard published an interim rule and request for comments in the
On November 3, 2015 and November 23, 2016, we promulgated temporary final rules for the Mavericks Surf Competition, which was most recently held on February 12, 2016, and subsequently not held in the 2016-2017 season after the sponsoring organization filed for bankruptcy. The temporary rules were needed to incorporate the updates noted in this Final Rule which include: Requiring buoy position maintenance by the event sponsors, expanding the definition of “spectator vessel” to include human powered craft and expanding the definition of “support vessel” to include jet skis. The Coast Guard determined a NPRM was necessary to afford the public the opportunity to comment on the aforementioned updates to the Interim Rule and because the Mavericks Surf Competition would occur before NPRM process was complete. Therefore to meet the event season deadline, a temporary final rule was published in lieu of a final rule. Past competitions have demonstrated the importance of restricting access to the competition area to only vessels in direct support of the competitors. In the Coast Guard's assessment, that temporary final rule provided an effective scheme to incorporate the Interim Rule updates and ensure the safety of life during the Mavericks Surf Competition.
On January 10, 2017, we published an NPRM titled Special Local Regulation; Mavericks Surf Competition, Half Moon Bay, CA (82 FR 2930). During the comment period which ended on February 9, 2017, three comments were received.
We are implementing the following changes to the Interim Rule based on comments received as well as lessons learned during the multi-agency planning process. The name of this event has changed over the years based on the sponsoring organization. The Coast Guard is promulgating this rule using the event name “Mavericks Surf Competition” to remove any affiliation with past or future sponsors and to keep the name of the event generic and applicable to any future sponsoring organizations. In addition to initially placing the buoys to outline Zones 1 and 2, this rule expands the event sponsor's designation of responsibility, outlined in the Interim Rule, to include buoy position maintenance throughout the course of the event. The definition of “support vessels” has been updated to specifically include jet skis and to clarify that they must be pre-designated and approved to serve as such for this event by the Officer in Charge of Marine Inspections (OCMI) prior to the competition. Finally, the definition of “spectator vessel” was expanded to specifically include human-powered craft.
Under 33 CFR 100.35, the Coast Guard District Commander has authority to promulgate certain special local regulations deemed necessary to ensure the safety of life on the navigable waters immediately before, during, and immediately after an approved regatta or marine parade. The Commander of Coast Guard District 11 has delegated to the Captain of the Port (COTP) San Francisco the responsibility of issuing such regulations.
The Mavericks Surf Competition is a one-day “Big Wave” surfing competition between big wave surfers specifically invited to participate by the event sponsor. The competition only occurs when 15-20 foot waves are sustained for over 24 hours and are combined with mild easterly winds of no more than 5-10 knots. The rock and reef ridges that make up the sea floor of the Pillar Point area, combined with optimal weather conditions, create the large waves for which Mavericks is known. Due to the hazardous waters surrounding Pillar Point at the time of the surfing competition, the Coast Guard is modifying and finalizing the interim rule which establishes a special local regulation in the vicinity of Pillar Point that restricts navigation in the area of the surf competition and in neighboring hazardous areas. This final rule is intended to ensure the safety of competitors by delineating a specific competition area, and to provide for the safety of spectators by imposing operating restrictions on those vessels.
As noted above, the Coast Guard received three respondent comments, noting several concerns, to the NPRM published on January 10, 2017. One comment recommends a more stringent specificity of swell conditions on the day of the event to promote the safe operation of vessels in the area. The environmental parameters outlined in this regulation are determining factors which are necessary precursors to optimal conditions for holding the big wave surfing event; conditions which typically are not optimal for vessel operations. In order to mitigate the risk to safe operation of vessels on the day of the surfing event, the Coast Guard promulgated the Interim Rule which defines an operating area for spectator vessels. The operating area provides an area for spectator vessels that is minimally influenced by the breaking surf. The Coast Guard determined that, the introduction of specific swell periodicity as a Coast Guard required condition to hold the competition would unnecessarily limit favorable days in which the surfing event could take place without further mitigating the risk to vessel operations on the day of the event.
One comment notes the economic determination in the NPRM to be erroneous, as the rule would have a significant economic impact on a substantial number of small entities. The Coast Guard disagrees with this
One comment recommends defining specific parameters that must be met by support vessels. The Coast Guard finds that mandating specific vessel parameters for “supporting vessels” unduly limits the event sponsor from considering all available assets capable of providing support to the event. Under the current proposal, all vessels proposed by the sponsor as “support vessels” must be vetted and approved for operation, in their capacity, as a “support vessel” prior to the day of the event. The vetting and approval of “support vessels” is conducted as a necessary precursor to the issuance of the annual Marine Event Permit. In this process, it is incumbent upon the event sponsor to propose only vessels necessary and capable of safely providing direct support to event competitors. Each proposed vessel is thoroughly evaluated by the OCMI and assessed in regards to the Coast Guard's ability to safely render assistance if needed on the day of the event. Proposed “support vessels” whose maneuverability, crew manning, or scope of support is found to be insufficient to safely operate within Zone 1, will be limited in the range of their operation in support of the event or denied approval to serve as a supporting vessel entirely, as stipulated in the documentation associated with the annual Marine Event Permit issued to the event sponsor.
One comment argued that the definition of “spectator vessel” was too vague. The Coast Guard finds that the definition of a “spectator vessel” as “any vessel or person, including human-powered craft, which is not designated by the sponsor as a support vessel” serves to differentiate between conspicuously marked “support vessels” which have previously been vetted and approved by the OCMI as part of the Marine Event Permit approval to provide direct support to the competitors, and all other vessels in the area on the day of the event.
No changes were made to the rule based upon the received comments; however the Coast Guard recognizes the importance of imposing appropriate controls on vessels attempting to gain access to the area encompassed by Zone 1 on the day of the competition.
The Coast Guard is finalizing the regulations governing the Mavericks Surf Competition. The Mavericks Surf Competition will take place on a day that presents favorable surf conditions between November 1 of each year and March 31 of the following year, from 6 a.m. until 6 p.m. The Mavericks Surf Competition can only occur when 15-20 foot waves are sustained for over 24 hours and are combined with mild easterly winds of no more than 5-10 knots. Unpredictable weather patterns and the event's narrow operating window limit the Coast Guard's ability to notify the public of the event. The Coast Guard would issue notice of the event as soon as practicable, but no later than 24 hours before Competition day via the Broadcast Notice to Mariners and issue a written Boating Public Safety Notice at least 24 hours in advance of Competition day. Also, the zones that are established by this final rule will be prominently marked by at least 8 buoys throughout the course of the event.
The Mavericks Surf Competition will occur in the navigable waters of Half Moon Bay, CA, in the vicinity of Pillar Point as depicted in National Oceanic and Atmospheric Administration (NOAA) Chart 18682. The Coast Guard will enforce a regulated area defined by an arc extending 1,000 yards from Sail Rock (37°29′34″ N., 122°30′02″ W.) excluding the waters within Pillar Point Harbor. All restrictions apply only between 6 a.m. and 6 p.m. on the day of the actual competition.
The effect of this regulation is to restrict navigation in the vicinity of Pillar Point during the Mavericks Surf Competition. During the enforcement period, the Coast Guard will direct the movement and access of all vessels within the regulated area. The regulated area will be divided into two zones. Zone 1 is designated as the competition area, and the movement of vessels within Zone 2 is controlled by the Patrol Commander (PATCOM).
This regulation is needed to keep spectators and vessels a safe distance away from the event participants and the hazardous waters surrounding Pillar Point. Past competitions have demonstrated the importance of restricting access to the competition area to only vessels in direct support of the competitors. Failure to comply with the lawful directions of the Coast Guard could result in additional vessel movement restrictions, citation, or both.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 (“Regulatory Planning and Review”) and 13563 (“Improving Regulation and Regulatory Review”) 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 (including potential economic, environmental, public health and safety effects, disruptive 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. Executive Order 13771 (“Reducing Regulation and Controlling Regulatory Costs”), directs agencies to reduce regulation and control regulatory costs and provides that “for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process.”
The Office of Management and Budget (OMB) has not designated this rule a significant regulatory action under section 3(f) of Executive Order 12866. Accordingly, OMB has not reviewed it. As this rule is not a significant regulatory action, this rule is exempt from the requirements of Executive Order 13771. See OMB's memorandum “Guidance Implementing Executive Order 13771, titled `Reducing Regulation and Controlling Regulatory Costs' ” (April 5, 2017).
The Regulatory Flexibility Act of 1980, 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 did not receive any comments from the Small Business Administration on the Interim rule published on October 15, 2014. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities.
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
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this 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 rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this 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 their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a regulated area of limited size and duration. Normally such actions are categorically excluded from further review under paragraph 34(h) of Figure 2-1 of Commandant Instruction M16475.lD. A Record of Environmental Consideration is available in the docket for this rulemaking. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Marine safety, Navigation (water), Reporting and recordkeeping requirements, and Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:
33 U.S.C. 1233; 33 CFR 1.05-1.
(a)
(b)
(c)
(d)
(1) Only support vessels may be authorized by the Patrol Commander (PATCOM) to enter Zone 1 during the competition.
(2) Entering the water in Zone 1 by any person other than the competitors is prohibited. Competitors may enter the water in Zone 1 from authorized support vessels only.
(3) Spectator vessels and support vessels within Zone 2 must maneuver as directed by PATCOM. Given the changing nature of the surf in the vicinity of the competition, PATCOM may close Zone 2 to all vessels due to hazardous conditions. Due to weather and sea conditions, the Captain of the Port may deny access to Zone 2 and the remainder of the regulated area to all vessels other than competitors and support vessels on the day of the event
(4) Entering the water in Zone 2 by any person is prohibited.
(5) Rafting and anchoring of vessels are prohibited within the regulated area.
(6) Only vessels authorized by the PATCOM will be permitted to tow other watercraft within the regulated area.
(7) Spectator and support vessels in Zones 1 and 2 must operate at speeds which will create minimum wake, in general, 7 miles per hour or less.
(8) When hailed or signaled by the PATCOM by a succession of sharp, short signals by whistle or horn, the hailed vessel must come to an immediate stop and comply with the lawful directions issued. Failure to comply with a lawful direction may result in additional operating restrictions, citation for failure to comply, or both.
(9) During the events, vessel operators may contact the PATCOM on VHF-FM channel 23A.
Coast Guard, DHS.
Temporary Interim rule and request for comments
The Coast Guard is establishing temporary safety zones in the navigable waters of the Humboldt Bay Entrance Channel, of Eureka, CA, Noyo River Entrance Channel, of Fort Bragg, CA, and Crescent City Harbor Entrance Channel, of Crescent City, CA to safeguard navigation safety during extreme environmental conditions. These safety zones are established to protect the safety of vessels transiting the areas from the dangers associated with extreme breaking surf and high wind conditions occurring in the Humboldt Bay Bar Channel, Noyo River Entrance Channel, and Crescent City Harbor Entrance Channels. When enforced, entry of persons or vessels into this temporary safety zone is prohibited unless specifically authorized by the Captain of the Port (COTP), San Francisco or his designated representative.
This rule is effective without actual notice from November 16, 2017 until 11:59 p.m. on March 31, 2018. For the purposes of enforcement, actual notice will be used from October 27, 2017 until November 16, 2017. This rule will be enforced when the COTP determines that the on scene conditions are hazardous and unsafe for vessel transits, typically expected to be 20 foot breaking seas at each location. Enforcement will be announced via local Broadcast Notice to Mariners.
You may submit comments view documents mentioned in this preamble as being available in the docket, go to
See the “Public Participation and Request for Comments” portion of the
If you have questions on this interim rule, call or email Lieutenant Commander Rebecca Deakin, U.S. Coast Guard Sector San Francisco; telephone (415) 399-7401 or email at
The Coast Guard is issuing this temporary interim rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.”
Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule. Publishing an NPRM would be impracticable in this case due to having received initial notice of the extreme environmental and weather conditions substantiating this rule on October 19, 2017.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port (COTP), San Francisco has determined that this rule is necessary to provide for the safety of Coast Guard members, mariners, and other vessels transiting the area where
This rule establishes three safety zones, respectively in the navigable waters of the Humboldt Bay Entrance Channel near Eureka, CA, the Noyo River Entrance Channel, near Fort Bragg, CA, and the Crescent City Harbor Entrance Channel, of Crescent City, CA, when the COTP determines that the on scene conditions are hazardous and unsafe for vessel transits, typically expected to be 20 foot breaking seas at each location. Enforcement will be announced via Broadcast Notice to Mariners between 12:01 a.m. on October 27, 2017 until 11:59 p.m. on March 31, 2018.
The effect of the temporary safety zones is to restrict navigation in the vicinity of the Humboldt Bay Entrance Channel, Noyo River Entrance Channel, and Crescent City Harbor Entrance Channel while the hazardous conditions associated with extreme environmental conditions exist, and until the Coast Guard deems the safety zone is no longer needed. Except for persons or vessels authorized by the COTP, no person or vessel may enter or remain in the restricted areas during times of enforcement. These regulated areas are needed to keep vessels away from the immediate vicinity of the hazardous conditions associated to ensure the safety of transiting vessels in each respective area.
We developed this rule after considering numerous statutes and Executive orders (E.O.s) related to rulemaking. Below we summarize our analyses based on a number of these statutes and E.O.s, and we discuss First Amendment rights of protestors.
E.O.s 12866 (“Regulatory Planning and Review”) and 13563 (“Improving Regulation and Regulatory Review”) 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 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, disruptive 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. Executive Order 13771 (“Reducing Regulation and Controlling Regulatory Costs”), directs agencies to reduce regulation and control regulatory costs and provides that “for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process.”
We expect the economic impact of this rule will not rise to the level of necessitating a full Regulatory Evaluation. This safety zone is limited in size, duration and location. In addition, although this rule restricts access to the waters encompassed by the safety zone, the effect of this rule will not be significant because the local waterway users will be notified via public Local Notice to Mariners to ensure the safety zone will result in minimum impact. The entities most likely to be affected are waterfront facilities, commercial vessels, and pleasure craft engaged in recreational activities.
The Regulatory Flexibility Act of 1980, 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 rule will not have a significant economic impact on a substantial number of small entities. This rule may affect the following entities, some of which may be small entities: Owners and operators of waterfront facilities, commercial vessels, and pleasure craft engaged in recreational activities and sightseeing, if these facilities or vessels are in the vicinity of the safety zone at times when this zone is being enforced. This rule will not have a significant economic impact on a substantial number of small entities for the following reasons: (i) This rule will encompass only a small portion of the waterway for a limited period of time while hazardous conditions exist, and (ii) the maritime public will be advised in advance of this safety zone via Broadcast Notice to Mariners.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
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 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
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under E.O. 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 rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.
Also, this rule does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone of limited size and duration. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Record of Environmental Consideration (REC) are available in the docket for this rulemaking. We seek any comments or information that may lead to the discovery of a significant environmental impact from this 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 Temporary Interim Rule as being available in this docket and all public comments, will be in our online docket at
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, and Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Department of Homeland Security Delegation No. 0170.1
(a)
(1) The navigable waters of the Humboldt Bay Bar Channel and the Humboldt Bay Entrance Channel, of Humboldt Bay, CA;
(2) The navigable waters of the Noyo River Entrance Channel as defined by the Area contained seaward of the Line of Demarcation with northern boundary of the line originating in approx position 39°25′41″ N., 123°48′37″ W. and extending 1200 yards at bearing 290° T & southern boundary of the line originating in approx position 39°25′38″ N., 123°48′36″ W. and extending 1200 yards at 281° T, in Fort Bragg, CA;
(3) The navigable waters of the Crescent City Harbor Entrance Channel, as defined by the area contained seaward of the line originating in approx position 41°44′36″ N., 124°11′18″ W. bearing 237°T and extending out to 1 NM of the Line of Demarcation in Crescent City, CA.
(b)
(c)
(2) The safety zones are closed to all vessel traffic, except as may be permitted by the COTP or the COTP's designated representative. Vessel operators given permission to enter or operate in the safety zones must comply with all directions given to them by the COTP or the COTP's designated representative.
(3) Vessel operators desiring to enter or operate within the Humboldt Bay Entrance Channel or Crescent City Harbor Entrance Channel safety zones during times of enforcement shall contact Station Humboldt Bay on VHF-FM channel 16 or at (707) 443-2213 between 6:30 a.m. and 10 p.m., or to Sector Humboldt Bay on VHF-FM channel 16 or at (707) 839-6113 if between 10 p.m. and 6:30 a.m. Vessel operators desiring to enter or operate within the Noyo River Entrance Channel safety zone during times of enforcement shall contact Station Noyo River on VHF-FM channel 16 or at (707) 964-6611 between 6:30 a.m. and 10 p.m., or to Sector Humboldt Bay on VHF-FM channel 16 or at (707) 839-6113 if between 10 p.m. and 6:30 a.m.
(d)
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the subject safety zone for the annual fireworks display that takes place every November on the Ohio River, Monongahela River and Allegheny River extending the entire width of the rivers. The zone is needed to protect vessels transiting the area and event spectators from the hazards associated with the fireworks display. During the enforcement period, entry into, transiting, or anchoring in the safety zone is prohibited to all vessels not registered with the sponsor as participants or official patrol vessels, unless specifically authorized by the Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a designated representative.
The regulations in the Table 1 in 33 CFR 165.801, No. 64, will be enforced from 8 p.m. until 9:30 p.m., on November 17, 2017.
If you have questions about this notice of enforcement, call or email MST1 Jennifer Haggins, Marine Safety Unit Pittsburgh, U.S. Coast Guard; telephone 412-221-0807, email
The Coast Guard will enforce the safety zone listed in the regulations in Table 1 in 33 CFR 165.801, No. 64. The safety zone is for the annual fireworks display on the Ohio River, from mile 0.0 to 0.3, Monongahela River mile 0.0 to 0.22 and Allegheny River mile 0.0 to 0.25, extending the entire width of the rivers, from 8 p.m. to 9:30 p.m. on November 17, 2017. This action is being taken to protect vessels transiting the area and event spectators from the hazards associated with the fireworks display. Entry into the safety zone is prohibited unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a designated representative. Persons or vessels desiring to enter into or passage through the safety zone must request permission from the COTP or a designated representative. If permission is granted, all persons and vessels shall comply with the instructions of the COTP or designated representative.
This notice of enforcement is issued under authority of 33 CFR 165.801 and 5 U.S.C. 552(a). In addition to this notice of enforcement in the
Coast Guard, DHS.
Correcting amendments.
On November 9, 2017, the Coast Guard published a rule establishing temporary safety zones in the Atlantic Ocean, off the coast of Rehoboth Beach, DE and in Breakwater Harbor near Cape Henlopen. The rule was made enforceable from November 6, 2017, through February 28, 2018. However, in regulatory text the February date was mistakenly given as February 28, 2017. This document corrects that error.
Effective November 16, 2017.
If you have questions on this rule, call or email Petty Officer Edmund Ofalt, Waterways Management Branch, U.S. Coast Guard Sector Delaware Bay; telephone (215) 271-4814, email
In its temporary final rule published on November 9, 2017, the Coast Guard established temporary safety zones near dredging and pipe laying operations, diving operations, and underwater construction operations (82 FR 52005). The
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
U.S. Army Corps of Engineers, DoD.
Final rule.
The U.S. Army Corps of Engineers published a document in the
Effective December 18, 2017.
Headquarters, U.S. Army Corps of Engineers, Operations and Regulatory Community of Practice, 441 G Street NW., Washington, DC 20314-1000.
Mr. David Olson, Headquarters, Operations and Regulatory Community of Practice, Washington, DC at 202-761-4922 or by email at
Pursuant to its authorities under Section 7 of the Rivers and Harbors Act of 1917 (40 State 266; 33 U.S.C. 1) and Chapter XIX of the Army Appropriations Act of 1919 (40 Stat. 892; 33 U.S.C. 3), the Corps is amending restricted area regulations at 33 CFR part 334 by revising § 334.815 to expand the previously established restricted area in the Menominee River, at the Marinette Marine Corporation Shipyard, Marinette, Wisconsin. The amendment would also add a provision of disestablishment whereby the restricted area would be disestablished by no later than November 17, 2025. By correspondence dated October 29, 2015, the Department of the Navy, requested that the Corps of Engineers amend the regulations concerning this restricted area.
On August 11, 2016, the Corps' St. Paul District issued a local public notice soliciting comments on the proposed rule from all known interested parties and no comments were received. The proposed rule was published in the August 10, 2016 edition of the
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 13771 directs agencies to control regulatory costs through a budgeting process. This proposed rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this proposed rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
The Corps has made a determination this proposed rule is not a significant regulatory action. This regulatory action determination is based on the size and location of the restricted area. The restricted area does not occupy the entire Federal navigation channel near the shipyard and vessels utilizing that channel can transit around the restricted area. An operator of a vessel may also transit the restricted area as long as he or she obtains permission from the Supervisor of Shipbuilding, Conversion and Repair, USN, Bath, ME or his/her authorized representative.
The Regulatory Flexibility Act of 1980, 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 Corps certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities. While some owners or operators of vessels that intend to transit the restricted area may be small entities, for the reasons stated in paragraph (a) above this rule would not have a significant economic impact on any vessel owner or operator. In addition, the restricted area is necessary to address a major anti-terrorism and safety concern due to the lack of perimeter fencing or physical denial system. Small entities can utilize navigable waters outside of the restricted area. Small entities may also transit the restricted area as long as they obtain permission from the Supervisor of Shipbuilding, Conversion and Repair, USN, Bath, ME or his/her authorized representative. The restricted area is necessary to provide adequate protection of U.S. Navy combat vessels, their materials, equipment to be installed therein, and crew, while located at the Marinette Marine Corporation Shipyard. The restricted area does not occupy the entire Federal navigation channel near the shipyard and vessels utilizing that channel can transit around the restricted area, or obtain permission to transit the restricted area. After considering the economic impacts of this restricted area regulation on small entities, I certify that this action will not have a significant impact on a substantial number of small entities.
c.
d.
Danger zones, Marine safety, Navigation (water), Restricted areas, Waterways.
For the reasons stated in the preamble, the Corps is amending 33 CFR part 334 to read as follows:
40 Stat. 266 (33 U.S.C. 1) and 40 Stat. 892 (33 U.S.C. 3).
(a)
(b)
(c)
(d)
Approved:
Environmental Protection Agency (EPA).
Final rule.
EPA is establishing tolerances for residues of tebufenozide in or on multiple commodities, which are identified and discussed later in this document. In addition, EPA is correcting commodity definitions, updating crop group tolerances, and harmonizing U.S. tolerances with Codex. EPA is also removing tolerances for residues of tebufenozide that are no longer needed due to the changes listed. EPA is also amending the existing tolerance for almond, hulls under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective November 16, 2017. However, certain regulatory actions will not occur until the date specified in the regulatory text. Objections and requests for hearings must be received on or before January 16, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2008-0824, is available at
Christina Scheltema, Pesticide Re-evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 308-2201; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2008-0824 in the subject line on the first page of your submission. All objections and requests for a hearing
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2008-0824, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
The proposed rule of October 14, 2016 (FRL-9952-75), provided for a 60-day comment period and invited public comments. EPA received anonymous public comments from three private citizens. The comments and EPA's response are presented in Unit IV. E.
In this final rule, the Agency is establishing, modifying, and revoking the tolerances as indicated in its proposal of October 14, 2016, under its authority in FFDCA section 408(e)(1)(A). EPA is also establishing an expiration date for the existing tolerances for fruit, pome.
EPA may issue a regulation establishing, modifying, or revoking a tolerance under FFDCA section 408(e).
As stated in the
There have been no changes in the Agency's assessment of the safety of these tolerances since the issuance of the proposal, and no additional information or concerns were raised by the commenters warranting a reconsideration of the Agency's safety finding in the proposal. Therefore, the Agency is incorporating the Aggregate Risk Assessment and Determination of Safety as contained in Unit III. of its October 14, 2016 proposal and relying upon the findings therein to support its conclusion that there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to tebufenozide residues.
An adequate enforcement methodology is available to enforce the tolerance expression, as indicated in the proposal.
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
As indicated in the proposed rule, EPA is harmonizing its U.S. tolerances for sugarcane; fruit, citrus, group 10-10; fruit, pome, group 11-10; and almond, hulls, with Codex MRLs.
In this final rule, EPA is converting the existing crop group tolerance on fruit, pome, to fruit, pome, group 11-10, and in the process, reducing the crop group tolerance from 1.5 ppm to 1.0 ppm to harmonize with Codex MRLs. For the commodities included in crop group 11-10 that are not covered by the fruit, pome tolerance, the new tolerances allow import of those additional commodities with residues of tebufenozide up to 1.0 ppm, which is not currently permitted under the existing tolerance. However, for the commodities currently in the crop group that continue to be included in crop group 11-10, the tolerance is reduced from 1.5 ppm to 1.0 ppm. With very few exceptions, all of the MRLs for tebufenozide on pome fruits are already at or below EPA's proposed tolerance level of 1.0 ppm. As a result, EPA believes that a reasonable interval between the publication of this rule and the effective date of these tolerances is not necessary; therefore, the Agency proposes to make the tolerance of 1.0 ppm for crop group 11-10, fruit, pome, effective upon publication of this final rule. Nonetheless, because this tolerance change represents a reduction in the allowable amount of tebufenozide residues allowed in or on fruit, pome, crop group 11, EPA is establishing an expiration date for the existing tolerances for fruit, pome, that is six months from the date of publication of this final rule. Before that date, residues of tebufenozide on those commodities will be permitted up to the 1.5 ppm level under the existing fruit, pome, tolerance; after that date, residues will need to comply with the new reduced 1 ppm tolerance level under crop group 11-10.
The Agency is reducing the tolerances on commodities in this crop group to harmonize with the Codex MRL. The reduction is appropriate based on available data and residues levels resulting from registered use patterns. This reduction in tolerance levels is not discriminatory; the same food safety standard contained in the FFDCA applies equally to domestically produced and imported foods. None of the other tolerance actions taken in this rulemaking restrict permissible pesticide residues below currently allowed levels in the United States. In accordance with the World Trade Organization's (WTO) Sanitary and Phytosanitary Measures (SPS) Agreement, EPA intends to promptly publish this action with the WTO.
Any commodities listed in the regulatory text of this document that are treated with the pesticides subject to this final rule, and that are in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(1)(5), as established by FQPA. Under this unit, any residues of this pesticide in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of the Food and Drug Administration that:
1. The residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA.
2. The residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption from tolerance. Evidence to show that food was lawfully treated may include records that verify the dates that the pesticide was applied to such food.
The Agency received three comments on its October 14, 2016 proposal. The comments and EPA's responses follow.
Therefore, the Agency has not changed its previous determination that the 30 ppm almond hull tolerance is safe.
EPA has determined that there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to tebufenozide residues. The details of the Agency's assessment of the safety of the tebufenozide tolerances may be found in the proposed rule; there have been no changes since its issuance. Therefore, EPA is incorporating the Aggregate Risk Assessment and Determination of Safety as contained in Unit III of its October 14, 2016 proposal to support the conclusion of a reasonable certainty of no harm.
The Agency hereby establishes tolerances for residues of tebufenozide in bushberry subgroup 13-07B at 3.0 ppm; caneberry subgroup 13-07A at 3.0 ppm; fruit, citrus, group 10-10 at 2.0 ppm; fruit, pome group 11-10 at 1.0 ppm; nut, tree, group 14-12, at 0.1 ppm; sugarcane, cane at 1.0 ppm; sugarcane, molasses at 3.0 ppm; and vegetable, fruiting, group 8-10 at 1.0 ppm. The Agency is also increasing the tolerance for almond, hulls from 25 ppm to 30 ppm. Further, upon the establishment of these tolerances, the Agency is removing the existing tolerances for apple; berry, group 13; fruit, citrus, group 10; nut, tree, group 14; pistachio; vegetable, fruiting, group 8; and walnut because they will be superseded by the newly established tolerances. Finally, the Agency is establishing a six-month expiration date for the current fruit, pome, tolerance.
In this final rule, EPA is establishing, modifying, and revoking tolerances under FFDCA section 408(e). The Office of Management and Budget (OMB) has exempted these types of actions (
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
(a) * * * (1) * * *
Department of the Treasury.
Interim rule.
Pursuant to Section 6103 of the Internal Revenue Code, taxpayer return information, with few exceptions, is confidential. Under this authority, officers and employees of the Department of the Treasury may have access to taxpayer return information as necessary for purposes of tax administration. The Department of the Treasury has determined that an Internal Revenue Service (IRS) contractor's compliance with the tax laws is a tax administration matter and that taxpayer return information is needed for determining an offeror's eligibility to receive an award, including but not limited to implementation of the statutory prohibition of making an award to corporations that have an unpaid Federal tax liability. This interim rule amends the Department of the Treasury Acquisition Regulation (DTAR) for the purposes of
Treasury invites comments on the topics addressed in this interim rule. Comments may be submitted to Treasury by any of the following methods: by submitting electronic comments through the federal government e-rulemaking portal,
In general, Treasury will post all comments to
Thomas O'Linn, Procurement Analyst, Office of the Procurement Executive, at (202) 622-2092.
The DTAR, which supplements the Federal Acquisition Regulation (FAR), is codified at 48 CFR Chapter 10.
For purposes of tax administration, the IRS has access to taxpayer return information that is not otherwise available to other Federal Agencies pursuant to 26 U.S.C. 6103(h)(1). The Department of the Treasury has determined that an IRS contractor's compliance with the tax laws is a tax administration matter. Additionally, 26 U.S.C. 6103(c) authorizes the IRS to disclose a taxpayer's return information to such person(s) as the taxpayer may designate in a consent to such disclosure. In many cases, however, the official signing a contract proposal on behalf of an offeror will not be an official to whom the IRS is authorized to disclose the offeror's tax information. Thus, in order to ensure that IRS is authorized is to discuss the offeror's own tax information with an authorized official of the offeror, a consent to disclosure is required. This consent to disclosure must be in the form of a separate written document pertaining solely to the authorized disclosure and must be signed and dated by an authorized person as required and defined in 26 U.S.C. 6103(c) and 26 CFR 301.6103(c)-1(e)(4).
This interim rule amends the DTAR to establish policies and procedures that facilitate successful, timely, and economical execution of IRS contractual actions in compliance with the FAR and various appropriation restrictions. Specifically, this interim rule establishes an express requirement for IRS contracting officers to use taxpayer return information that is available only to IRS to perform a tax check on the apparent successful offeror for purposes of determining eligibility to enter into a contract with the IRS. The IRS has established an internal Procedure, Guidance and Information (PGI) that further supplements the DTAR requirement for IRS contracting officers to use when conducting a tax check. To ensure compliance with 26 U.S.C. 6103(h)(1) and to safeguard taxpayer return information, the PGI restricts the number of personnel within the IRS Office of Procurement who have access to tax compliance information. The PGI also limits the amount of information provided to the contracting officer regarding a delinquent Federal tax liability. Upon notification by the contracting officer that the offeror has a delinquent Federal tax liability, the offeror may provide the contracting officer with documentation that demonstrates the offeror's tax status as paid-in-full or that an approved payment agreement has been reached, at which time the contracting officer will coordinate with the appropriate office within IRS to validate the offeror's tax status (see FAR 9.104-5(a)(1), (b)(1) and (e)).
The offeror may want to take steps to confirm it does not have a delinquent Federal tax liability prior to submission of its response to the solicitation. If the offeror recently settled a delinquent Federal tax liability, the offeror may want to take steps to obtain information in order to demonstrate the offeror's responsibility to the contracting officer, if such information is requested (see FAR 9.104-5(a)(1) and (b)(1)).
This provision will apply to all IRS solicitations regardless of the dollar value, including commercial items (including Commercially Available Off-the-Shelf items). This determination is consistent with the FAR requirements regarding the inclusion of the provisions 52.209-5, 52.209-11 and 52.212-3 as well as various appropriation restrictions.
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.
Tax liability is a serious matter and there have been a number of congressional hearings and subsequent actions taken by Congress to ensure that appropriated funds are not spent with entities with a delinquent Federal tax liability. Most recently, Section 744 of Division E of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) (and similar provisions in prior appropriations acts since 2012) prohibits the Federal Government from entering into a contract with any corporation where the awarding agency is aware of an unpaid Federal tax liability, unless the agency has considered suspension or debarment of the corporation and has made a determination that this further action is not necessary to protect the interests of the Government. This prohibition has been implemented in the FAR under FAR 9.104-5. Considering all these factors, it is in the interest of the United States Government to only award contracts to entities that are responsible and law abiding.
As such a determination has been made under the authority of the Secretary of Treasury that urgent and compelling reasons exist to promulgate this interim rule without prior opportunity for public comment. Even absent this rule, IRS would have a duty under the appropriations act provision not to award contracts to entities with delinquent tax liability, and to review available tax information for this purpose. However, IRS would not have clear authority to discuss any adverse information with the offeror to which it pertained. The only effect of delaying the rule to consider public comment would be to increase the likelihood that offerors will be disqualified due to adverse tax information that could have been clarified or resolved if the rule were in place. For the same reason, the effective date is set as immediately upon publication. However, pursuant to 41 U.S.C. 1707 and FAR 1.501-3(b), Treasury will consider public comments received in response to this interim rule in the formation of the final rule.
The Regulatory Flexibility Act (5 U.S.C. chapter 6) generally requires agencies to conduct an initial regulatory flexibility analysis and a final regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements, unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities.
It is hereby certified that this interim rule will not have a significant economic impact on a substantial number of small entities. This interim rule will amend the DTAR to establish an internal process that strengthens IRS' compliance with appropriation act restrictions and the FAR prohibition of entering into a contract with contractors having a delinquent Federal tax liability (see FAR subpart 9.1) and should not have significant economic impacts on small entities other than the potential for not receiving award if the small entity has a delinquent Federal tax liability. This rule does not impose any new reporting, recordkeeping or other compliance requirements. The rule does not duplicate, overlap, or conflict with any other Federal rules. No significant alternatives were identified during the development of this rule. Notwithstanding this certification, the Department welcomes comments on the potential impact on small entities.
Government procurement.
Accordingly, the Department of the Treasury amends 48 CFR Chapter 10 as follows:
41 U.S.C. 418(b).
(b) Internal Revenue Service (IRS) contracting officers shall comply with the requirements of subpart 1009.70 once an offeror has been identified as the apparent successful offeror.
This subpart prescribes the IRS policies and procedures for performing a tax check on the apparent successful offeror to determine eligibility to receive an award.
As used in this subpart—
(a) There are various Federal laws and regulations that in aggregate prohibit the Federal Government from entering into a contract with an entity where the awarding agency is aware of an unpaid Federal tax liability (see FAR subpart 9.1) unless the agency has considered suspension or debarment and has made a determination that this further action is not necessary to protect the interests of the Government.
(b) IRS contracting officers shall include a provision in all solicitations regardless of dollar value, which contains a consent to disclosure to be signed and dated by a person authorized to act on behalf of the offeror as defined in 26 CFR 301.6103(c)-1(e)(4). The consent to disclosure will authorize officers and employees of the Department of the Treasury, including the IRS, to disclose the results of the tax check to the authorized representative(s) of the offeror. In the absence of a signed and dated consent to disclosure in an offer, taxpayer return information of the offeror may not be disclosed, which subsequently may remove the offeror from eligibility to receive an award.
IRS contracting officers shall not proceed with award, at any dollar value, until a tax check has been performed on the apparent successful offeror. See IRS Procedures, Guidance, and Information (PGI) 9.1.
(a) The contracting officer, regardless of an offeror's response in paragraph (a)(1) of the provision 52.209-5, Certification Regarding Responsibility Matters, paragraph (b)(1) of the provision at FAR 52.209-11, or paragraphs (h) and (q)(2)(i) of the provision at FAR 52.212-3 (see FAR 9.104-5(b)), shall request a tax check through the IRS designated point of contact. The request shall include only the information required for purposes of conducting the tax check.
(b) If the result of the tax check demonstrates the offeror as having a delinquent Federal tax liability, the contracting officer shall—
(1) Confirm the offer includes a signed and dated consent to disclosure (see 1052.209-70, Notice and Consent to Disclose and Use of Taxpayer Return Information), the absence of which may remove the offeror from eligibility to receive an award under the solicitation because taxpayer return information of the offeror may not be disclosed.
(2) If the consent to disclosure is completed in the offer, notify the authorized representative(s) of the offeror that a delinquent Federal tax liability exists and therefore the offeror is ineligible for award.
(i) If upon notification the offeror provides the contracting officer with documentation, within the timeframe specified by the contracting officer, that demonstrates the offeror's tax status as being paid-in-full or that an approved payment agreement is in place, the contracting officer will coordinate with the appropriate office within IRS to validate the tax status. If the offeror is found to be tax compliant, the contracting officer will notify the offeror of such. Assuming the offeror meets all other standards of responsibility, the offeror is eligible for award.
(3) Notify, in accordance with IRS PGI 9.1, the Department of the Treasury official responsible for suspension and debarment for purposes of requesting a determination in accordance with FAR 9.104-5(a)(2) and FAR 9.104-5(b)(3) respectively before an award to that contractor can be made.
(c) If the result of the tax check demonstrates the offeror as tax compliant then the offeror is eligible for award, assuming all other standards of responsibility have been met.
(d) The contracting officer shall include in the contract file documentation that verifies the tax check was conducted and if the results confirm a delinquent Federal tax liability existed at the time of award, confirmation that the offeror was notified of such.
(a) The contracting officer shall insert the provision 1052.209-70, Notice and Consent to Disclose and Use of Taxpayer Return Information, in all IRS solicitations regardless of dollar value, including solicitations for acquisition of commercial items (including Commercially Available Off-The-Shelf items).
41 U.S.C. 1707.
As prescribed in 1009.7005, insert the following provision:
(a)
(b)
(1) The performance of a tax check is one means that will be used for determining an offeror's eligibility to receive an award in response to this solicitation (see FAR 9.104). As a result, the offeror may want to take steps to confirm it does not have a delinquent Federal tax liability prior to submission of its response to this solicitation. If the offeror recently settled a delinquent Federal tax liability, the offeror may want to take steps to obtain information in order to demonstrate the offeror's responsibility to the contracting officer (see FAR 9.104-5).
(c) The offeror shall execute the consent to disclosure provided in paragraph (d) of this provision and include it with the submission of its offer. The consent to disclosure shall be signed by an authorized person as required and defined in 26 U.S.C. 6103(c) and 26 CFR 301.6103(c)-1(e)(4).
(d) Consent to disclosure. I hereby consent to the disclosure of taxpayer return information (as defined in 26 U.S.C. 6103(b)(2)) as follows:
The Department of the Treasury, Internal Revenue Service, may disclose the results of the tax check conducted in connection with the offeror's response to this solicitation, including taxpayer return information as necessary to resolve any matters pertaining to the results of the tax check, to the authorized representatives of [
I am aware that in the absence of this authorization, the taxpayer return information of [
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS announces that the 2017 summer flounder commercial quota allocated to the State of Rhode Island has been harvested. Vessels issued a commercial Federal fisheries permit for summer flounder may not land summer flounder in Rhode Island for the remainder of calendar year 2017, unless additional quota becomes available through a transfer from another state. Regulations governing the summer flounder fishery require publication of this notification to advise vessel and dealer permit holders that Federal commercial quota is no longer available to land summer flounder in Rhode Island.
Effective 0001 hours, November 14, 2017, through December 31, 2017.
Cynthia Hanson, (978) 281-9180, or
Regulations governing the summer flounder fishery are found at 50 CFR part 648. The regulations require annual specification of a commercial quota that is apportioned on a percentage basis among the coastal states from Maine through North Carolina. The process to set the annual commercial quota and the percent allocated to each state is described in § 648.102.
The coastwide commercial quota for summer flounder for the 2017 calendar year is 5,658,260 lb (2,566,544 kg) (81 FR 93842, December 22, 2016). The percent allocated to vessels landing summer flounder in Rhode Island is 15.68298 percent, resulting in an initial commercial quota of 887,542 lb (402,582 kg). Rhode Island has received one quota transfer of 380 lb (172 kg) from New Jersey on October 4, 2017 (82 FR 46936), bringing its commercial quota to 887,922 lb (402,755 kg).
The NMFS Administrator for the Greater Atlantic Region (Regional Administrator) monitors the state commercial landings and determines when a state's commercial quota has been harvested. NMFS is required to publish a notice in the
Section 648.4(b) provides that Federal permit holders agree, as a condition of the permit, not to land summer flounder in any state that the Regional Administrator has determined no longer has commercial quota available. Therefore, effective 0001 hours, November 14, 2017, landings of summer flounder in Rhode Island by vessels holding summer flounder commercial Federal fisheries permits are prohibited for the remainder of the 2017 calendar year, unless additional quota becomes available through a transfer and is
This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866.
The Assistant Administrator for Fisheries, NOAA, finds good cause pursuant to 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment because it would be contrary to the public interest. This action closes the commercial summer flounder fishery for Rhode Island until January 1, 2018, under current regulations. The regulations at § 648.103(b) require such action to ensure that summer flounder vessels do not exceed quotas allocated to the states. If implementation of this closure was delayed to solicit prior public comment, the quota for this fishing year will be exceeded, thereby undermining the conservation objectives of the Summer Flounder Fishery Management Plan. The Assistant Administrator further finds, pursuant to 5 U.S.C. 553(d)(3), good cause to waive the 30-day delayed effectiveness period for the reason stated above.
16 U.S.C. 1801
Federal Aviation Administration (FAA), DOT.
Notice of proposed interim airworthiness criteria.
The FAA announces the availability of and requests comments on proposed airworthiness criteria for the Unmanned Aircraft System, FlightScan Corporation, Camcopter S-100. This document provides proposed policy for airworthiness criteria to address the designation of applicable regulations and other criteria for special classes of aircraft. In addition to the proposed airworthiness criteria presented in this document, we are also referencing operational considerations that have been used to support the development of the airworthiness criteria. We consider these proposed criteria to be interim because we anticipate the evolution of new operational criteria will necessitate additional airworthiness criteria in order to allow for the operation of the Camcopter S-100 in the National Airspace System. When those additional operational criteria are further established, we will again provide public notice of proposed policy with additional airworthiness criteria along with changes incorporated to these criteria based on the public comments received.
Send comments on or before December 18, 2017.
Send comments identified by docket number FAA-2017-1058 using any of the following methods:
•
•
•
•
Mr. Raymond Johnston, AIR-692, Federal Aviation Administration, Policy & Innovation Division, Small Airplane Standards Branch, Aircraft Certification Service, 901 Locust, Room 301, Kansas City, MO 64106, telephone (816) 329-4159, facsimile (816) 329-4090.
We invite interested people to take part in the development of this policy by sending written comments, data, or views. The most helpful comments reference a specific portion of the airworthiness criteria, explain the reason for any recommended change, and include supporting data. We ask that you send us two copies of written comments.
We will consider all comments received on or before the closing date for comments. We will consider comments filed late if it is possible to do so without incurring expense or delay. We may change these airworthiness criteria based on received comments or based on evolving operational criteria.
FlightScan Corporation (FlightScan) applied to the Federal Aviation Administration on June 1, 2015 for special class type certification under Title 14, Code of Federal Regulations (14 CFR) 21.17(b) for the Camcopter S-100 Unmanned Aircraft System (UAS).
The Camcopter S-100 UAS (S-100) consists of the unmanned aircraft (UA) and its associated elements (including communication links and the components that control the unmanned aircraft). The S-100 is a vertical take-off UAS that is of the traditional main/tail rotor helicopter design. The fuselage is made of carbon fiber and titanium. The S-100 is powered by a liquid cooled rotary engine and has a maximum take-off weight of 440 pounds which can include a maximum payload of up to 110 pounds. The main rotor diameter is approximately 134 inches. The UAS is intended to be used to conduct airborne surveying of power transmission infrastructure using aerial photogrammetry.
To facilitate the establishment of an initial risk class for UAS, the FAA proposes a scale of risk based on kinetic energy.
The following operational considerations were evaluated during the development of this document:
1. The S-100 would be used for power transmission line survey operations. It operates in a designated corridor and area within the right-of-way of the power transmission lines and is operationally limited to 100 feet above and laterally within 100 feet of the power line it would be surveying.
2. While there is minimal population exposure within the power transmission line right-of-way, the mission path would cross several public highways and pass in close proximity to several neighborhoods with population densities of less than 950 people per square mile.
3. The S-100 would operate Beyond Visual Line of Sight (BVLOS). BVLOS for this UAS is defined as those operations that do not conform to the definition of Visual Line of Sight (VLOS) in 14 CFR part 107.31 at amendment 107-1.
4. The radio control uplink and downlink would operate within frequencies approved by the Federal Communications Commission (FCC).
5. This S-100 is designed to operate both autonomously and manually by the pilot-in-command (PIC).
6. Minimum crew includes one PIC, one mission specialist, and one mission flight director.
7. The minimum crew would operate only one S-100 at any time.
8. The aircraft would remain within Radio Line of Sight (RLOS) of the control station. RLOS refers to the straight and unobstructed path between the transmitting and receiving antennas.
9. The control station would be ground based.
10. All crew would be FAA certified airmen with current and applicable medical credentials.
11. All crew would successfully complete required crew training.
12. Maintenance personnel would hold appropriate FAA maintenance certificates.
13. Maintenance personnel would complete required maintenance training.
The FAA's ongoing development of operational criteria will necessitate the incorporation of additional airworthiness criteria into the S-100 and may also necessitate future clarity of the airworthiness criteria published in the
1. Command and Control (*)
2. Sense and Avoid (SAA) Equipage (*)—SAA systems could serve as a means of compliance with 14 CFR 91.113 right-of-way rules and others. Issues associated with the use of SAA systems to comply with 14 CFR 91 requirements and others, if any, must be identified; and
3. Noise Act Finding (*)—Noise standards have not been developed for UAS.
The FAA has not previously published airworthiness criteria for UAS. The FAA proposes new type certification airworthiness criteria for the FlightScan Camcopter S-100 as found in
Food and Drug Administration, HHS.
Notification of availability.
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled “Best Practices for Convening a GRAS Panel.” This draft guidance document is intended for any person who is responsible for a conclusion that a substance may be used in food on the basis of the generally recognized as safe (GRAS) provision of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) when that person convenes a panel of experts (“GRAS panel”) to independently evaluate whether the available scientific data, information, and methods establish that the substance is safe under the conditions of its intended use in human food or animal food. This draft guidance provides our current thinking on best practices to identify GRAS panel members who have appropriate and balanced expertise; to take steps to reduce the risk that bias (or the appearance of bias) will affect the credibility of the GRAS panel's output (often called a “GRAS panel report”), including the assessment of potential GRAS panel members for conflict of interest and the appearance of conflict of interest; and to limit the data and information provided to a GRAS panel to public information (
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on this draft guidance before we issue the final version of the guidance, submit either electronic or written comments by May 15, 2018. For comments related to the collection of information provisions in this draft guidance, submit either electronic or written comments by January 16, 2018.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at:
Submit written requests for single copies of the draft guidance to Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS-200), 5001 Campus Dr., College Park, MD 20740 or to the Office of Surveillance and Compliance (HFV-200), 7519 Standish Pl., Rockville, MD 20855. Send two self-addressed adhesive labels to assist that office in processing your request. See the
Section 201(s) of the FD&C Act (21 U.S.C. 321(s)) defines a “food additive” as any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use. Under this definition, a substance that is GRAS under the conditions of its intended use is not a “food additive” and is therefore not subject to mandatory premarket review by FDA under section 409 of the FD&C Act (21 U.S.C. 348). In this document, we refer to a person who is responsible for a conclusion that a substance may be used in human food or animal food on the basis of the GRAS provision of the FD&C Act, without premarket review by FDA under section 409 of the FD&C Act, as the “proponent” of that substance.
We have established regulations implementing the GRAS provision of section 201(s) of the FD&C Act in part 170 (21 CFR part 170) for human food and in part 570 (21 CFR part 570) for animal food. Those regulations include a voluntary procedure (“GRAS notification procedure”) through which a proponent may notify us of a conclusion that a substance is GRAS under the conditions of its intended use in human food (part 170, subpart E) or animal food (part 570, subpart E). Under the interim pilot program, we have filed and responded to more than 600 GRAS notices for substances intended for use in human food and 18 GRAS notices for substances intended for use in animal food (80 FR 54960 at 54964, August 17, 2016).
In some cases, the process whereby the proponent evaluates whether the available data and information support a conclusion that a substance is GRAS under the conditions of its intended use includes considering the opinion of a “GRAS panel” of qualified experts who independently evaluate whether the available scientific data, information, and methods establish that a substance is safe under the conditions of its intended use in human food or animal food. Depending on the outcome of the GRAS panel's analysis, the proponent could either reach a conclusion regarding the safety of the substance under the conditions of its intended use, or be advised of one or more issues (such as gaps in the data and information, or alternative interpretations of the available data and information) that warrant investigation before a conclusion can be drawn about whether the substance is safe under the conditions of its intended use. When the outcome of the GRAS panel's analysis supports the proponent's conclusion that a substance is safe under the conditions of its intended use, in essence the proponent then relies on the members of the GRAS panel to act as a proxy for the larger scientific community knowledgeable about the safety of substances directly or
A GRAS panel is one mechanism that proponents have used to demonstrate that the safety of a substance under the conditions of its intended use is generally recognized by qualified experts. However, the use of a GRAS panel is not the only mechanism for doing so and the use of a GRAS panel does not necessarily mean that the GRAS criteria have been met (81 FR 54960 at 54974-54975, August 17, 2016).
We are announcing the availability of a draft guidance for industry entitled “Best Practices for Convening a GRAS Panel.” We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations. This is not a significant regulatory action subject to Executive Order 12866.
This draft guidance document is intended for any proponent who convenes a GRAS panel and provides our current thinking on best practices to identify GRAS panel members who have appropriate and balanced expertise; to take steps to reduce the risk that bias (or the appearance of bias) will affect the credibility of a GRAS panel report, including the assessment of potential GRAS panel members for conflict of interest and the appearance of conflict of interest; and to limit the data and information provided to a GRAS panel to public information (
This draft guidance contains proposed information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the collection of information associated with this draft guidance, we invite comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information collected; and (4) ways to minimize the burden of the information collected on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Using the data in our inventories of GRAS notices submitted for substances intended for use in human food (Ref. 1) and animal food (Ref. 2) during the time period of April 17, 1997, through September 5, 2017, we calculate that 396 proponents submitted at least one GRAS notice for a substance intended for use in human food, and 15 proponents submitted at least one GRAS notice for a substance intended for use in animal food. During that time period, there were three proponents who had submitted at least one GRAS notice for a substance intended for use in human food and at least one GRAS notice for a substance intended for use in animal food. However, for the purpose of this analysis, we make the conservative assumption that there will be no overlap between proponents who submit GRAS notices for substances intended for use in human food and proponents who submit GRAS notices for substances intended for use in animal food. Therefore, the total number of proponents who have submitted at least one GRAS notice to FDA is 411 (396 proponents + 15 proponents = 411 proponents).
We have very little information about the number of proponents who have documented a GRAS conclusion without reporting that GRAS conclusion to FDA in the form of a GRAS notice. To estimate the number of such proponents, we used a publicly
The database attributes the 158 documented GRAS conclusions not reported to FDA to 142 different proponents. However, 62 of these proponents have also submitted a GRAS notice to FDA and, thus, we calculate that the database attributes documented GRAS conclusions to 80 proponents who have not submitted a GRAS notice to FDA (142 proponents listed in the database—62 proponents who we already counted because they submitted a GRAS notice to FDA). We also make the conservative assumption that the number of proponents who have documented GRAS conclusions without reporting them to FDA since FDA began receiving GRAS notices is twice as high as recorded in the database—
The publicly available database does not record documented GRAS conclusions for substances intended for use in animal food. However, based on the number of annual GRAS notices submitted to FDA in recent years, we previously estimated that the number of annual GRAS notices submitted to FDA for substances intended for use in animal food would be 50 percent of the number of annual GRAS notices submitted to FDA for substances intended for use in human food (
To estimate the total number of proponents, we are adding 240 estimated proponents who have not reported their documented GRAS conclusions to FDA to the 411 proponents who have already submitted at least one GRAS notice to FDA for a total of 651 proponents who will document a GRAS conclusion (240 non-reporting proponents + 411 reporting proponents = 651 total proponents). As already stated, for the purpose of this analysis we make the conservative assumption that all of these proponents who document GRAS conclusions (
We have not previously estimated the annual number of documented GRAS conclusions that are not reported to FDA as a GRAS notice. For the purpose of this analysis, to estimate such GRAS conclusions we used the same database (Ref. 3) that we used to estimate the total number of proponents who document GRAS conclusions without reporting the GRAS conclusions to FDA in the form of a GRAS notice. As already stated, the oldest recorded entry in the database is for the year 1995. However, with the exception of that single entry for 1995, the remaining entries are for the years 2001 and beyond. In addition, the current year (2017) has not reached its end. Therefore, we use 16 years (
We have information about the percent of proponents who convene a GRAS panel for a documented GRAS conclusion and also submit a GRAS notice to FDA. During the time period April 17, 1997, through September 5, 2017, on average, 63 percent of proponents who submitted a GRAS notice for a substance intended for use in human food, and 60 percent of proponents who submitted a GRAS notice for a substance intended for use in animal food, convened a GRAS panel. We therefore estimate that, on an annual basis, 32 proponents will convene a GRAS panel and submit a GRAS notice to FDA for substances intended for use in human food (63 percent × 50 proponents = 31.5 proponents; rounded up to 32 proponents), and 15 proponents will convene a GRAS panel and submit a GRAS notice to FDA for substances intended for use in animal food (60 percent × 25 proponents = 15 proponents). We calculate that the total number of proponents who will convene a GRAS panel and submit a GRAS notice to FDA is 47 proponents (32 proponents who submit GRAS notices for substances intended for use in human food + 15 proponents who submit GRAS notices for substances intended for use in animal food = 47 proponents). We also assume that all proponents will document the application of a written GRAS panel policy to each member of the GRAS panel.
We have very little information about the percent of proponents who convene a GRAS panel for a documented GRAS conclusion but do not report their documented GRAS conclusions to FDA as a GRAS notice. For the purpose of this analysis, we make the conservative assumption that all 30 proponents who annually document GRAS conclusions without reporting them to FDA will convene a GRAS panel. Taking into account the estimated number of proponents who convene a GRAS panel and submit a GRAS notice to FDA, and the estimated number of proponents who convene a GRAS panel but do not submit a GRAS notice to FDA, we calculate that the total number of proponents who will convene a GRAS panel and document the application of the written GRAS panel policy to each member of a GRAS panel on an annual basis is 77 proponents (47 proponents who submit GRAS notices to FDA+ 30 proponents who do not submit GRAS notices = 77 proponents).
Based on the recommendations in the draft guidance, if finalized, we assume that all GRAS panels will include at least 3 panel members (with expertise in chemistry or biochemistry, toxicology, and exposure assessment) and that some GRAS panels will include as many as 6 panel members with expertise that reflects the physical, chemical, and biological properties of the substance and the scientific questions that arise in relation to the conditions of its intended use. We assume that a GRAS panel will include 5 panel members on average. We also assume that the proponent will reject at least one individual with applicable expertise due to a financial conflict of interest or the appearance of a financial or non-financial conflict of interest and, thus, that 77 proponents will document the application of the written GRAS panel policy to 6 individual GRAS panel members, for a total of 462 documentations by proponents of the application of the written GRAS panel policy (77 proponents × 6 individual panel members = 462 documentations). As shown in table 2, we estimate that it will take 16 hours to document the application of the written GRAS policy to each panel member, for a total of 7,392 hours (462 documentations × 16 hours per documentation = 7,392 hours). As shown in table 3, we assume that all 462 individuals who are being considered as members of a GRAS panel will each need 4 hours to provide applicable information to the proponent, for a total of 1,848 hours (462 individuals × 4 hours per individual = 1,848 hours).
There are no estimated capital costs or operating and maintenance costs associated with this information collection for the application of a written GRAS panel policy to individuals being considered as members of a GRAS panel.
Persons with access to the Internet may obtain the draft guidance at either
The following references are on display with the Dockets Management Staff (see
U.S. Army Corps of Engineers, DoD.
Notice of proposed rulemaking and request for comments.
The Corps of Engineers is proposing to establish a permanent restricted area for the U. S. Coast Guard in waters of Curtis Creek and Arundel Cove located in Baltimore, Maryland. The establishment of the restricted area is necessary to reflect the current security needs at U. S. Coast Guard Yard (CG Yard), Baltimore, Maryland, including the protection of Coast Guard-wide military assets. The CG Yard is the Coast Guard's only shipyard and its largest industrial facility. It performs major ship, electronics, and heavy weapons overhaul, repair, and manufacture. The CG Yard is also the host command for various Coast Guard commands supporting local and nationwide Coast Guard missions.
Written comments must be submitted on or before December 18, 2017.
You may submit comments, identified by docket number COE-2017-0003, by any of the following methods:
Mr. David Olson, Headquarters, Operations and Regulatory Division, Washington, DC at 202-761-4922, or Steve Elinsky, Corps of Engineers, Baltimore District, Regulatory Branch, at 410-962-4503.
Pursuant to its authorities in Section 7 of the Rivers and Harbors Act of 1917 (40 Stat. 266; 33 U.S.C. 1) and Chapter XIX of the Army Appropriations Act of 1919 (40 Stat. 892; 33 U.S.C. 3), the Corps of Engineers is proposing amendments to regulations in 33 CFR part 334 for the establishment of a permanent restricted area in waters of Curtis Creek and Arundel Cove in Baltimore, Maryland. In a memorandum dated November 28, 2016, the U.S. Coast Guard requested that the Corps establish this permanent restricted area. The proposed permanent restricted area is necessary to fulfill the current security needs of the U.S. Coast Guard at this facility. The CG Yard is the U.S. Coast Guard's only shipyard and is its largest industrial facility. The CG Yard is used for major ship, electronics, and heavy weapons overhaul, repair, and manufacture.
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 13771 directs agencies to control regulatory costs through a budgeting process. This proposed rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this proposed rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
The Corps has made a determination this proposed rule is not a significant regulatory action. This regulatory action determination is based on the size, duration, and location of the restricted area. The restricted area occupies only a portion of the waterway and a vessel that needs to transit the restricted area may do so if the operator of the vessel obtains permission from the Commanding Officer, U.S. Coast Guard Yard or his/her designated representative. Fishing, crabbing, trawling, net-fishing, and other aquatic activities may also be conducted with prior approval from the Commanding Officer, U.S. Coast Guard Yard or his/her designated representative.
The Regulatory Flexibility Act of 1980, 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 Corps certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities. While some owners or operators of vessels that intend to transit the restricted area may be small entities, for the reasons stated in paragraph (a) above this rule would not have a significant economic impact on any vessel owner or operator. In addition, the restricted area is necessary to address the current security needs at CG Yard, Baltimore, Maryland, including the protection of Coast Guard-wide military assets. Small entities can utilize navigable waters outside of the restricted area. Small entities may also transit the restricted area as long as they obtain permission from the Commanding Officer, CG Yard or his/her designated representative. Unless information is obtained to the contrary during the comment period, the Corps expects that the economic impact of the proposed restricted area would have practically no impact on the public, any anticipated navigational hazard or interference with existing waterway traffic. After considering the economic impacts of this restricted area regulation on small entities, I certify that this action will not have a significant impact on a substantial number of small entities.
Due to the administrative nature of this action and because there is no intended change in the use of the area, the Corps expects that this regulation, if adopted, will not have a significant impact to the quality of the human environment and, therefore, preparation of an environmental impact statement will not be required. An environmental assessment will be prepared after the public notice period is closed and all comments have been received and considered.
This proposed rule does not impose an enforceable duty among the private sector and, therefore, it is not a Federal private sector mandate and it is not subject to the requirements of either Section 202 or Section 205 of the Unfunded Mandates Act. We have also found under Section 203 of the Act, that small governments will not be significantly and uniquely affected by this rulemaking.
Danger zones, Marine safety, Navigation (water), Restricted areas, Waterways.
For the reasons set out in the preamble, the Corps proposes to amend 33 CFR part 334 as follows:
40 Stat. 266 (33 U.S.C. 1) and 40 Stat. 892 (33 U.S.C. 3).
(a)
(b)
(2) All persons, vessels and other craft are prohibited from entering, transiting, drifting, dredging or anchoring within the restricted area as described in paragraph (a) of this section without prior approval from the Commanding Officer, U.S. Coast Guard Yard or his/her designated representative.
(3) The restrictions described in paragraph (b)(1) of this section are in effect 24 hours a day, 7 days a week.
(c)
U.S. Army Corps of Engineers, DoD.
Notice of proposed rulemaking and request for comments.
The U.S. Army Corps of Engineers (Corps) is proposing to establish a no anchorage restricted area within waters along the Back Bay of Biloxi shoreline of the Keesler Air Force Base (KAFB) located in Biloxi, Mississippi, on behalf of a request by the United States Air Force (USAF) 81st Security Forces Anti-Terrorism Office. The proposed no anchorage restricted area will be established by placing 12 buoys to demarcate the approximately 10,000 feet of shoreline east to west and extend approximately 150 feet from the shoreline of the base. The proposed restricted area is essential to address a major anti-terrorism and safety concern due to the lack of perimeter fencing or physical denial system.
Written comments must be submitted on or before December 18, 2017.
You may submit comments, identified by docket number COE-2017-0007, by any of the following methods:
Mr. David Olson, Headquarters, Operations and Regulatory Community of Practice, Washington, DC at 202-761-4922 or Mr. Don Mroczko, U.S. Army Corps of Engineers, Mobile District, at 251-690-3185.
The 81st Security Forces Anti-Terrorism Office, KAFB, located in Biloxi, Mississippi is responsible for USAF perimeter security at KAFB located in Biloxi, Mississippi. In accordance with Department of Defense and Department of the Air Force guidance, the 81st Security Forces Anti-Terrorism Office is responsible for the antiterrorism efforts and force protection of Department of the Air Force assets under his or her charge.
In response to a request by the USAF, and pursuant to its authorities in Section 7 of the Rivers and Harbors Act of 1917 (40 Stat 266; 33 U.S.C. 1) and Chapter XIX of the Army Appropriations Act of 1919 (40 Stat 892; 33 U.S.C. 3), the Corps is proposing to amend the regulations in 33 CFR part 334 by establishing a new restricted area.
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 13771 directs agencies to control regulatory costs through a budgeting process. This proposed rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this proposed rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
The Corps has made a determination this proposed rule is not a significant regulatory action. This regulatory action determination is based on the size, duration, and location of the restricted area. The restricted area occupies a small portion of the waterway and a vessel that needs to transit the restricted area may do so if the operator of the vessel obtains permission from the USAF 81st Security Forces Anti-Terrorism Office, KAFB or its authorized representative.
The Regulatory Flexibility Act of 1980, 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 Corps certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities. While some owners or operators of vessels that intend to transit the restricted area may be small entities, for the reasons stated in paragraph (a) above this rule would not have a significant economic impact on any vessel owner or operator. In addition, the restricted area is necessary to address a major anti-terrorism and safety concern due to the lack of perimeter fencing or physical denial system. Small entities can utilize navigable waters outside of the restricted area. Small entities may also transit the restricted area as long as they obtain permission from the USAF 81st Security Forces Anti-Terrorism Office, KAFB, Biloxi, Mississippi, or its authorized representative. The restricted area is necessary for security of KAFB. Unless information is obtained to the contrary during the comment period, the Corps expects that the economic impact of the proposed restricted area would have practically no impact on the public, any anticipated navigational hazard or interference with existing waterway traffic. After considering the economic impacts of this restricted area regulation on small entities, I certify that this action will not have a significant impact on a substantial number of small entities.
The Corps expects that the proposed rule will not have a significant impact to the quality of the human environment and, therefore, preparation of an environmental impact statement will not be required. An environmental assessment will be prepared after the public notice period is closed and all comments have been received and considered. After it is prepared, it may be reviewed at the District office listed at the end of the
The proposed rule does not impose an enforceable duty among the private sector and, therefore, is not a Federal private sector mandate and is not subject to the requirements of Section 202 or 205 of the Unfunded Mandates Reform Act (Pub. L. 104-4, 109 Stat. 48, 2 U.S.C. 1501
Danger Zones, Navigation (water), Restricted areas, Waterways.
For the reasons set out in the preamble, the Corps proposes to amend 33 CFR part 334 as follows:
40 Stat. 266 (33 U.S.C. 1) and 40 Stat. 892 (33 U.S.C. 3).
(a)
(b)
(2) The restricted area is in effect twenty-four hours per day and seven days a week (24/7).
(3) Should warranted access into the restricted navigation area be needed, all entities are required to contact the USAF 81st Security Forces Anti-Terrorism Office, KAFB, Biloxi, Mississippi, or its authorized representative.
(c)
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to repeal the emission standards and other requirements for heavy-duty glider vehicles, glider engines, and glider kits based on a proposed interpretation of the Clean Air Act (CAA) under which glider vehicles would be found not to constitute “new motor vehicles” within the meaning of CAA section 216(3), glider engines would be found not to constitute “new motor vehicle engines” within the meaning of CAA section 216(3), and glider kits would not be treated as “incomplete” new motor vehicles. Under this proposed interpretation, EPA would lack authority to regulate glider vehicles, glider engines, and glider kits under CAA section 202(a)(1).
Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2014-0827, at
Air and Radiation Docket and Information Center, EPA Docket Center, EPA/DC, EPA WJC West Building, 1301 Constitution Ave. NW., Room 3334, Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the Air Docket is (202) 566-1742.
Julia MacAllister, Office of Transportation and Air Quality, Assessment and Standards Division, Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI 48105; telephone number: 734-214-4131; email address:
This action relates to a previously promulgated final rule that affects companies that manufacture, sell, or import into the United States glider vehicles. Proposed categories and entities that might be affected include the following:
This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely covered by these rules. This table lists the types of entities that we are aware may be regulated by this action. Other types of entities not listed in the table could also be regulated. To determine whether your activities are regulated by this action, you should carefully examine the applicability criteria in the referenced regulations. You may direct questions regarding the applicability of this action to the persons listed in the preceding
The basis for the proposed repeal of those provisions of the final rule entitled Greenhouse Gas Emissions and Fuel Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles—Phase 2 (the Phase 2 rule)
This proposed interpretation is a departure from the position taken by EPA in the Phase 2 rule. There, EPA interpreted the statutory definitions of “new motor vehicle” and “new motor vehicle engines” in CAA section 216(3) as including glider vehicles and glider engines, respectively. The proposed interpretation also departs from EPA's position in the Phase 2 rule that CAA section 202(a)(1) authorizes the Agency to treat glider kits as “incomplete” new motor vehicles.
It is settled law that EPA has inherent authority to reconsider, revise, or repeal past decisions to the extent permitted by law so long as the Agency provides a reasoned explanation. This authority exists in part because EPA's interpretations of the statutes it administers “are not carved in stone.”
After reconsidering the statutory language, EPA proposes to adopt a reading of the relevant provisions of the CAA under which the Agency would lack authority under CAA section 202(a)(1) to impose requirements on glider vehicles, glider engines, and glider kits and therefore proposes to remove the relevant rule provisions. At the same time, under CAA section 202(a)(3)(D), EPA is authorized to “prescribe requirements to control” the “practice of rebuilding heavy-duty engines,” including “standards applicable to emissions from any rebuilt heavy-duty engines.” 42 U.S.C. 7521(a)(3)(D).
A glider vehicle (sometimes referred to simply as a “glider”) is a truck that utilizes a previously owned powertrain (including the engine, the transmission, and usually the rear axle) but which has new body parts. When these new body parts (which generally include the tractor chassis with frame, front axle, brakes, and cab) are put together to form the “shell” of a truck, the assemblage of parts is referred to collectively as a “glider kit.” The final manufacturer of the glider vehicle,
Section 202(a)(1) of the CAA directs that EPA “shall by regulation prescribe,” in “accordance with the provisions” of section 202, “standards applicable to the emission of any air pollutant from any . . . new motor vehicles or new motor vehicle engines.” 42 U.S.C. 7521(a)(1). CAA section 216(2) defines “motor vehicle” to mean “any self-propelled vehicle designed for transporting persons or property on a street or highway.” 42 U.S.C. 7550(2). A “
Comments submitted to EPA during the Phase 2 rulemaking stated that gliders are approximately 25% less expensive than new trucks,
Some commenters questioned EPA's authority to regulate glider vehicles as “new motor vehicles,” to treat glider engines as “new motor vehicle engines,” or to impose requirements on glider kits. Commenters also pointed out what they described as the overall environmental benefits of gliders. For instance, one commenter stated that “rebuilding an engine and transmission uses 85% less energy than manufacturing them new.”
In the Phase 2 rule, EPA found that it was “reasonable” to consider glider vehicles to be “new motor vehicles” under the definition in CAA section 216(3).
Following promulgation of the Phase 2 rule, EPA received from representatives of the glider industry a joint petition requesting that the Agency reconsider the application of the Phase 2 rule to glider vehicles, glider engines, and glider kits.
The petitioners took particular issue with what they characterized as EPA's having “assumed that the nitrogen oxide (`NO
The petitioners maintained that the results of the study “showed that remanufactured engines from model years between 2002 and 2007 performed roughly on par with OEM `certified' engines,” and “in some instances even out-performed the OEM engines.”
Further, the petitioners complained that the Phase 2 rule had “failed to consider the significant environmental
EPA responded to the glider industry representatives' joint petition by separate letters on August 17, 2017, stating that the petition had “raise[d] significant questions regarding the EPA's authority under the Clean Air Act to regulate gliders.”
EPA is proposing that the statutory interpretations on which the Phase 2 rule predicated its regulation of glider vehicles, glider engines, and glider kits were incorrect. EPA proposes an interpretation of the relevant language of the CAA under which glider vehicles are excluded from the statutory term “new motor vehicles” and glider engines are excluded from the statutory term “new motor vehicle engines,” as both terms are defined in CAA section 216(3). Consistent with this interpretation of the scope of “new motor vehicle,” EPA is further proposing that it has no authority to treat glider kits as “incomplete” new motor vehicles under CAA section 202(a)(1).
As was noted, a “new motor vehicle” is defined by CAA section 216(3) to mean, in relevant part, a “motor vehicle the equitable or legal title to which has never been transferred to an ultimate purchaser.” 42 U.S.C. 7550(3). In basic terms, a glider vehicle consists of the new components that make up a glider kit, into which a previously owned powertrain has been installed. Prior to the time a completed glider vehicle is sold, it can be said that the vehicle's “equitable or legal title” has yet to be “transferred to an ultimate purchaser.” It is on this basis that the Phase 2 rule found that a glider vehicle fits within the definition of “new motor vehicle.” 81 FR 73514 (October 25, 2016).
EPA's rationale for applying this reading of the statutory language was that “[g]lider vehicles are typically marketed and sold as `brand new' trucks.” 81 FR 73514 (October 25, 2016). EPA took note of one glider kit manufacturer's own advertising materials that represented that the company had “ `mastered the process of taking the `Glider Kit' and installing the components to work seamlessly
In proposing a new interpretation of the relevant statutory language, EPA now believes that its prior reading was not the best reading, and that the Agency failed to consider adequately the most important threshold consideration:
Focusing solely on that portion of the statutory definition that provides that a motor vehicle is considered “new” prior to the time its “equitable or legal title” has been “transferred to an ultimate purchaser,” a glider vehicle would appear to qualify as “new.” As the Supreme Court has repeatedly counseled, however, that is just the beginning of a proper interpretive analysis. The “definition of words in isolation,” the Court has noted, “is not necessarily controlling in statutory construction.”
Assessed in light of these principles, it is clear that EPA's reading of the statutory definition of “new motor vehicle” in the Phase 2 rule fell short. First, that reading failed to account for the fact that, at the time this definition of “new motor vehicle” was enacted, it is likely that Congress did not have in mind that the definition would be construed as applying to a vehicle comprised of new body parts and a previously owned powertrain. The manufacture of glider vehicles to salvage the usable powertrains of trucks wrecked in accidents goes back a number of years.
Furthermore, the concept of deeming a motor vehicle to be “new” based on its “equitable or legal title” not having been transferred to an “ultimate purchaser” appears to have originated with an otherwise unrelated federal statute that predated Title II by a few years—
Among other things, the Disclosure Act requires that a label be affixed to the windshield or side window of new automobiles, with the label providing such information as the Manufacturer's Suggested Retail Price.
In 1965, Congress amended the then-existing Clean Air Act, and for the first time enacted provisions directed at the control of air pollution from motor vehicles.
Section 208 of the 1965 CAA defined “motor vehicle” in terms identical to those in the CAA today: “any self-propelled vehicle designed for transporting persons or property on a street or highway.” Public Law 89-272, 79 Stat. 995. The 1965 CAA defined “new motor vehicle” and “new motor vehicle engine” to mean, as relevant here, “a motor vehicle the equitable or legal title to which has never been transferred to an ultimate purchaser; and the term `new motor vehicle engine' ” to mean “an engine in a new motor vehicle or a motor vehicle engine the equitable or legal title to which has never been transferred to the ultimate purchaser.”
While the legislative history of the 1965 CAA does not expressly indicate that Congress based its definition of “new motor vehicle” on the definition of “new automobile” first adopted by the Automobile Information Disclosure Act of 1958, it seems clear that such was the case. The statutory language of the two provisions is identical in all pertinent respects,
Subsequently, the statutory language from the 1965 CAA, defining the terms “motor vehicle,” “new motor vehicle,” “new motor vehicle engine,” “ultimate purchaser,” and “manufacturer” was incorporated verbatim in the Air Quality Act of 1967 (1967 AQA).
The fact that Congress, in first devising the CAA's definition of “new motor vehicle” for purposes of Title II, drew on the pre-existing definition of “new automobile” in the Automobile Information Disclosure Act of 1958 serves to illuminate congressional intent. As with the Disclosure Act, Congress in the 1965 CAA selected the point of first transfer of “equitable or legal title” to serve as a bright line—
Given this, EPA does not believe that congressional intent as to the meaning of the term “new motor vehicle” can be clearly ascertained on the basis of an isolated reading of a few words in the statutory definition, where that reading is divorced from the structure and history of the CAA as a whole. Based on that structure and history, it seems likely that Congress understood a “new motor vehicle,” as defined in CAA § 216(3), to be a vehicle comprised entirely of new parts and certainly not a vehicle with a used engine. At a minimum, ambiguity exists. This leaves EPA with the task of providing an “answer based on a permissible construction of the statute.”
EPA is proposing to interpret “new motor vehicle,” as defined in CAA § 216(3), as not including glider vehicles. This is a reasonable interpretation—and commonsense would agree—insofar as it takes account of the reality that significant elements of a glider vehicle (
In other words, EPA now believes that, in defining “new motor vehicle,” Congress did not intend that a vehicle comprised of a new outer shell conjoined to a previously owned powertrain should be treated as a “new” vehicle, based solely on the fact that the vehicle may have been assigned a new title following assembly. In this regard, insofar as Title II's regulatory regime was at its inception directed at the emissions produced by new vehicle
EPA proposes to find that, since a glider vehicle does not meet the statutory definition of a “new motor vehicle,” it necessarily follows that a glider engine is not a “new motor vehicle engine” within the meaning of CAA section 216(3). Under that provision, a motor vehicle engine is deemed to be “new” in either of two circumstances: (1) The engine is “in a new motor vehicle,” or (2) the “equitable or legal title” to the engine has “never been transferred to the ultimate purchaser.” The second of these circumstances can never apply to a glider engine, which is invariably an engine that has been previously owned.
As to the first circumstance, a glider engine is installed in a glider kit, which in itself is not a “motor vehicle.” A glider kit becomes a “motor vehicle” only after an engine (and the balance of the powertrain) has been installed. But while adding a previously owned engine to a glider kit may result in the creation of a “motor vehicle,” the assertion that the previously owned engine thereby becomes a “
Under EPA's proposed interpretation, EPA would have no authority to regulate glider kits under CAA section 202(a)(1). If glider vehicles are not “new motor vehicles,” which is the interpretation of CAA section 216(3) that EPA is proposing here, then the Agency lacks authority to regulate glider kits as “incomplete” new motor vehicles. Further, given that a glider kit lacks a powertrain, a glider kit does not explicitly meet the definition of “motor vehicle,” which, in relevant part, is defined to mean “any
EPA believes that its proposed interpretation is the most reasonable reading of the relevant statutory language, and that its proposed determination, based on this interpretation, that regulation of glider vehicles, glider engines, and glider kits is not authorized by CAA section 202(a)(1) is also reasonable. EPA seeks comment on this interpretation.
Comments submitted in the Phase 2 rulemaking docket lead EPA to believe that a glider vehicle is often a suitable option for those small businesses and independent operators who cannot afford to purchase a new vehicle, but
EPA also seeks comment on the matter of the anticipated purchasing behavior on the part of the smaller trucking operations and independent drivers if the regulatory provisions at issue were to repealed. Further, EPA seeks comment on the relative expected emissions impacts if the regulatory requirements at issue here were to be repealed or were to be left in place.
Finally, EPA seeks comment on whether, if the Agency were to determine not to adopt the interpretation of CAA sections 202(a)(1) and 216(3) being proposed here, EPA should nevertheless revise the “interim provisions” of Phase 2 rule, 40 CFR 1037.150(t)(1)(ii), to increase the exemption available for small manufacturers above the current limit of 300 glider vehicles per year. EPA seeks input on how large an increase would be reasonable, were the Agency to increase the limit in taking final action. Further, EPA seeks comment on whether, if the Agency were to determine not to adopt the statutory interpretation being proposed here, EPA should nevertheless extend by some period of time the date for compliance for glider vehicles, glider engines, and glider kits set forth in 40 CFR 1037.635. EPA seeks comment on what would be a reasonable extension of the compliance date.
EPA has a fundamental obligation to ensure that the regulatory actions it takes are authorized by Congress, and that the standards and requirements that it would impose on the regulatory community have a sound and reasonable basis in law. EPA is now proposing to find that the most reasonable reading of the relevant provisions of the CAA, including CAA sections 202(a)(1), 216(2), and 216(3) is that glider vehicles should not be regulated as “new motor vehicles,” that glider engines should not be regulated as “new motor vehicle engines,” and that glider kits should not be regulated as “incomplete” new motor vehicles. Based on this proposed interpretation, EPA is proposing to repeal those provisions of the Phase 2 rule applicable to glider vehicles, glider engines, and glider kits.
We request comment by January 5, 2018 on all aspects of this proposal. This section describes how you can participate in this process.
Materials related to the Heavy-Duty Phase 2 rulemaking are available in the public docket noted above and at:
Direct your submittals to Docket ID No. EPA-HQ-OAR-2014-0827. EPA's policy is that all submittals received will be included in the public docket without change and may be made available online at
Do not submit information to the docket that you consider to be CBI or otherwise protected through
EPA will hold a public hearing on the date and at the location stated in the
Do not submit this information to EPA through
When submitting comments, remember to:
• Identify the action by docket number and other identifying information (subject heading,
• Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
• Describe any assumptions and provide any technical information and/or data that you used.
• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
• Provide specific examples to illustrate your concerns, and suggest alternatives.
• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
• Make sure to submit your comments by the comment period deadline identified in the
This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review. Any changes made in response to OMB recommendations have been documented in the docket.
This action is expected to be an Executive Order 13771 deregulatory action. This proposed rule is expected
This action does not impose an information collection burden under the PRA because it does not contain any information collection activities. It would only eliminate regulatory requirements for glider manufacturers.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden, or otherwise has a positive economic effect on the small entities subject to the rule. Small glider manufacturers would be allowed to produce glider vehicles without meeting new motor vehicle emission standards. We have therefore concluded that this action will have no adverse regulatory impact for any directly regulated small entities.
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local, or tribal governments.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications as specified in Executive Order 13175. This proposed rule will be implemented at the Federal level and affects glider manufacturers. Thus, Executive Order 13175 does not apply to this action.
This action is not subject to Executive Order 13045 because it is not an economically significant regulatory action as defined by Executive Order 12866. However, the Emission Requirements for Glider Vehicles, Glider Engines, and Glider Kits was anticipated to lower ambient concentrations of PM
In general, current expectations about future emissions of pollution from these trucks is difficult to forecast given uncertainties in future technologies, fuel prices, and the demand for trucking. Furthermore, the proposed action does not affect the level of public health and environmental protection already being provided by existing NAAQS and other mechanisms in the CAA. This proposed action does not affect applicable local, state, or federal permitting or air quality management programs that will continue to address areas with degraded air quality and maintain the air quality in areas meeting current standards. Areas that need to reduce criteria air pollution to meet the NAAQS will still need to rely on control strategies to reduce emissions. To the extent that states use other mechanisms in order to comply with the NAAQS, and still achieve the criteria pollution reductions that would have occurred under the CPP, this proposed rescission will not have a disproportionate adverse effect on children's health.
This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.
This rulemaking does not involve technical standards.
Pursuant to Executive Order 12898 (59 FR 7629, February 16, 1994), EPA considered environmental justice concerns of the final HD Phase 2 rule. EPA's evaluation of human health and environmental effects on minority, low-income or indigenous populations for the final HD Phase 2 rule is presented in the Preamble, Section VIII.A.8 and 9 (81 FR 73844-7, October 25, 2016). We have not evaluated the impacts on minority, low-income or indigenous populations that may occur as a result of the proposed action to rescind emissions requirements for heavy-duty glider vehicles and engines. EPA likewise has not considered the economic and employment impacts of this rule specifically as they relate to or might impact minority, low-income and indigenous populations.
Environmental protection, Administrative practice and procedure, Air pollution control, Confidential business information, Labeling, Motor vehicle pollution, Reporting and recordkeeping requirements, Warranties.
For the reasons set out in the preamble, title 40, chapter I of the Code of Federal Regulations is proposed to be amended as set forth below.
42 U.S.C. 7401-7671q.
(t) [Reserved]
(1) A motor vehicle for which the ultimate purchaser has never received the equitable or legal title is a new motor vehicle. This kind of vehicle might commonly be thought of as “brand new” although a new motor vehicle may include previously used parts. Under this definition, the vehicle is new from the time it is produced until the ultimate purchaser receives the title or places it into service, whichever comes first.
(2) An imported heavy-duty motor vehicle originally produced after the 1969 model year is a new motor vehicle.
42 U.S.C. 7401-7671q.
(f) * * *
(5) The standard-setting part may apply further restrictions to situations involving installation of used engines to repower equipment.
Federal Crop Insurance Corporation, USDA.
Renewal and Revision of the Currently Approved Information Collection.
In accordance with the Paperwork Reduction Act of 1995, this notice announces a public comment period on the information collection requests (ICRs) associated with the Standard Reinsurance Agreement and Appendices I, II and IV administered by Federal Crop Insurance Corporation (FCIC). Appendix III is excluded because it contains the Data Acceptance System requirements.
Written comments on this notice will be accepted until close of business January 16, 2018.
FCIC prefers that comments be submitted electronically through the Federal eRulemaking Portal. You may submit comments, identified by Docket ID No. FCIC-17-0002, by any of the following methods:
•
•
All comments received, including those received by mail, will be posted without change to
David L. Miller, Director, Risk Management Agency, at the address listed above, telephone (202) 720-9830.
FCIC executes the same form of reinsurance agreement, called the Standard Reinsurance Agreement (SRA), with sixteen participating insurers approved for the 2018 reinsurance year. Appendix I of the SRA, Regulatory Duties and Responsibilities, sets forth the company's responsibilities as required by statute. Appendix I includes; a) Conflict of Interest data collection, which in addition to the insurance companies reinsured by FCIC, encompasses the insurance companies' employees and their contracted agents and loss adjusters; and b) Controlled Business data collection from all employed or contracted agents. Appendix II of the SRA, the Plan of Operations (Plan), sets forth the information the insurer is required to file with RMA for each reinsurance year they wish to participate. The Plan's information enables RMA to evaluate the insurer's financial and operational capability to deliver the crop insurance program in accordance with the Act. Estimated premiums by fund by state, and retained percentages along with current policyholders surplus are used in calculations to determine whether to approve the insurer's requested maximum reinsurable premium volume for the reinsurance year per 7 CFR 400 Subpart L. This information has a direct effect upon the insurer's amount of retained premium and associated liability and is required to calculate the insurer's underwriting gain or loss.
Appendix IV of the SRA, Quality Control and Program Integrity, establishes the minimum annual agent and loss adjuster training requirements, and quality control review procedures and performance standards required of the insurance companies. FCIC requires each insurer to submit, for each reinsurance year, a Quality Control Report to FCIC containing details of the results of their completed reviews. The insurance companies must also provide an annual Training and Performance Evaluation Report which details the evaluation of each agent and loss adjuster and reports of any remedial actions taken by the Company to correct any error or omission or ensure compliance with the SRA. The submission of these reports is included in Appendix II.
FCIC is requesting the Office of Management and Budget (OMB) to extend the approval of this information collection for an additional 3 years.
The purpose of this notice is to solicit comments from the public concerning the continuation of the current information collection activity as associated with the SRA in effect for the 2018 and subsequent reinsurance years. These comments will help us:
(1) Evaluate whether the current collection of information is necessary
(2) Evaluate the accuracy of the agency's estimate of the burden of the current collection of information;
(3) Enhance the quality, utility, and clarity of the information being collected; and
(4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies,
The estimate below shows the burden that will be placed upon the following affected entities.
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Commission on Civil Rights.
Announcement of monthly planning meetings.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the Delaware State Advisory Committee to the Commission will convene by conference call, on Monday, November 20 at 10:00 a.m. (EST). The purpose of the meeting is to discuss what more needs to be done to complete the record of the briefing meeting conducted in Wilmington on November 1, 2017, titled,
Monday, November 20, 2017, at 10:00 a.m. (EST).
Ivy L. Davis, at
Interested members of the public may listen to the discussion by calling the following toll-free conference call number: 1-800-210-9006 and conference call ID: 4124362. Please be advised that before placing them into the conference call, the conference call operator may ask callers to provide their names, their organizational affiliations (if any), and email addresses (so that callers may be notified of future meetings). Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number herein.
Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-888-364-3109 and providing the operator with the toll-free conference call number: 1-800-210-9006 and conference call ID: 4124362.
Members of the public are invited to submit written comments; the comments must be received in the regional office approximately 30 days after each scheduled meeting. Written comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, or emailed to Evelyn Bohor at
Records and documents discussed during the meeting will be available for public viewing as they become available at
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) preliminarily determines that certain tool chests and cabinets (tool chests) from the Socialist Republic of Vietnam (Vietnam) are being, or are likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is October 1, 2016, through March 31, 2017.
Applicable November 16, 2017.
Dmitry Vladimirov, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-0665.
This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). The Department published the notice of initiation of this investigation on May 9, 2017.
The products covered by this investigation are tool chests from Vietnam. For a complete 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. The Department has calculated export prices and constructed export prices in accordance with sections 772(a) and (b) of the Act, respectively. Because Vietnam is a non-market economy, within the meaning of section 771(18) of the Act, the Department has calculated normal value (NV) in accordance with section 773(c) of the Act. In addition, pursuant to section 776(a) and (b) of the Act, the Department preliminarily has relied on facts otherwise available, with adverse inferences, for the Vietnam-wide entity. For a full description of the methodology underlying the Department's preliminary determination,
In the
The Department preliminarily determines that the following estimated weighted-average dumping margins exist:
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 subject merchandise 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
The Department intends to disclose to interested parties the calculations performed in connection with this preliminary determination within five days of its public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
As provided in section 782(i)(1) of the Act, the Department intends to verify information relied upon in making its final determination.
Case briefs or other written comments, with the exception of scope case briefs or scope comments,
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce,
All documents must be filed electronically using ACCESS. An electronically-filed request must be received successfully in its entirety by ACCESS no later than 5:00 p.m. Eastern Time on the established due date.
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 the petitioners. Pursuant to 19 CFR 351.210(e)(2), the Department 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 September 19, 2017, pursuant to 19 CFR 351.210(e), the Clearwater Metal Single Entity requested that the Department postpone the final determination and that provisional measures be extended to a period not to exceed six months.
In accordance with section 733(f) of the Act, the Department will notify the International Trade Commission (ITC) of its preliminary determination of sales at LTFV. If the 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 the final determination whether imports of the subject merchandise are materially injuring, or threaten material injury to, the U.S. industry.
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 scope of this investigation covers certain metal tool chests and tool cabinets, with drawers, (tool chests and cabinets), from the Socialist Republic of Vietnam (Vietnam). The scope covers all metal tool chests and cabinets, including top chests, intermediate chests, tool cabinets and side cabinets, storage units, mobile work benches, and work stations and that have the following physical characteristics:
(1) A body made of carbon, alloy, or stainless steel and/or other metals;
(2) two or more drawers for storage in each individual unit;
(3) a width (side to side) exceeding 15 inches for side cabinets and exceeding 21 inches for all other individual units but not exceeding 60 inches;
(4) a body depth (front to back) exceeding 10 inches but not exceeding 24 inches; and
(5) prepackaged for retail sale.
For purposes of this scope, the width parameter applies to each individual unit,
Prepackaged for retail sale means the units may, for example, be packaged in a cardboard box, other type of container or packaging, and may bear a Universal Product Code, along with photographs, pictures, images, features, artwork, and/or product specifications. Subject tool chests and cabinets are covered whether imported in assembled or unassembled form. Subject merchandise includes tool chests and cabinets produced in Vietnam but assembled, prepackaged for retail sale, or subject to other minor processing in a third country prior to importation into the United States. Similarly, it would include tool chests and cabinets produced in Vietnam that are later found to be assembled, prepackaged for retail sale, or subject to other minor processing after importation into the United States.
Subject tool chests and cabinets may also have doors and shelves in addition to drawers, may have handles (typically mounted on the sides), and may have a work surface on the top. Subject tool chests and cabinets may be uncoated (
Subject tool chests and cabinets may be packaged as individual units or in sets. When packaged in sets, they typically include a cabinet with one or more chests that stack on top of the cabinet. Tool cabinets act as a base tool storage unit and typically have rollers, casters, or wheels to permit them to be moved more easily when loaded with tools. Work stations and mobile work benches are tool cabinets with a work surface on the top that may be made of rubber, plastic, metal, wood, or other materials.
Top chests are designed to be used with a tool cabinet to form a tool storage unit. The top chests may be mounted on top of the base tool cabinet or onto an intermediate chest. They are often packaged as a set with tool cabinets or intermediate chests, but may also be packaged separately. They may be packaged with mounting hardware (
Side cabinets are designed to be bolted or otherwise attached to the side of the base storage cabinet to expand the storage capacity of the base tool cabinet.
Subject tool chests and cabinets also may be packaged with a tool set included. Packaging a subject tool chest and cabinet with a tool set does not remove an otherwise covered subject tool chest and cabinet from the scope. When this occurs, the tools are not part of the subject merchandise.
All tool chests and cabinets that meet the above definition are included in the scope unless otherwise specifically excluded.
Excluded from the scope of the investigation are tool boxes, chests, and cabinets with bodies made of plastic, carbon fiber, wood, or other non-metallic substances.
Also excluded from the scope of the investigation are industrial grade steel tool chests and cabinets. The excluded industrial grade steel tool chests and cabinets are those:
(1) Having a body that is over 60 inches in width; or
(2) having each of the following physical characteristics:
(a) A body made of steel that is 0.047 inches or more in thickness;
(b) a body depth (front to back) exceeding 21 inches; and
(c) a unit weight that exceeds the maximum unit weight shown below for each width range:
Also excluded from the scope of the investigation are service carts. The excluded service carts have all of the following characteristics:
(1) Casters, wheels, or other similar devices which allow the service cart to be rolled from place to place;
(2) a flat top or flat lid on top of the unit that opens;
(3) a space or gap between the casters, wheels, or other similar devices, and the bottom of the enclosed storage space (
(4) a total unit height, including casters, of less than 48 inches.
Also excluded from the scope of the investigation are non-mobile work benches. The excluded non-mobile work benches have all of the following characteristics:
(1) A solid top working surface;
(2) no drawers, one drawer, or two drawers in a side-by-side configuration; and
(3) the unit is supported by legs and has no solid front, side, or back panels enclosing the body of the unit.
Also excluded from the scope of this investigation are metal filing cabinets that are configured to hold hanging file folders and are classified in the Harmonized Tariff Schedule of the United States (HTSUS) at subheading 9403.10.0020.
Merchandise subject to this investigation is classified under HTSUS categories 9403.20.0021, 9403.20.0026, 9403.20.0030 and 7326.90.8688, but may also be classified under HTSUS category 7326.90.3500. While HTSUS subheadings are provided for convenience and Customs purposes, the written description of the scope of this investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On October 4, 2017, the Department of Commerce (the Department) published its notice of initiation and preliminary results of a changed circumstances review (CCR) of the antidumping duty order on carbon and certain alloy steel wire rod (wire rod) from Mexico to determine whether ArcelorMittal Mexico, S.A. de C.V. (AMM) is the successor-in-interest to ArcelorMittal Las Truchas, S.A. de C.V. (AMLT). No interested parties submitted case briefs or requested a hearing with respect to the Department's notice of initiation and preliminary results. Therefore, based on the information on the record, we continue to determine that AMM is the successor-in-interest to ALMT.
Applicable November 16, 2017.
Keith Haynes, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-5139.
The Department published in the
The merchandise covered by the order is carbon and certain alloy steel wire rod. The product is currently classified under the Harmonized Tariff Schedule of the United States (HTSUS) item numbers 7213.91.3000, 7213.91.3010, 7213.91.3011, 7213.91.3015, 7213.91.3020, 7213.91.3090, 7213.91.3091, 7213.91.3092, 7213.91.3093, 7213.91.4500, 7213.91.4510, 7213.91.4590, 7213.91.6000, 7213.91.6010, 7213.91.6090, 7213.99.0030, 7213.99.0031, 7213.99.0038, 7213.99.0090, 7227.20.0000, 7227.20.0010, 7227.20.0020, 7227.20.0030, 7227.20.0080, 7227.20.0090, 7227.20.0095, 7227.90.6010, 7227.90.6020, 7227.90.6030, 7227.90.6035, 7227.90.6050, 7227.90.6051, 7227.90.6053, 7227.90.6058, 7227.90.6059, 7227.90.6080, and 7227.90.6085 of the HTSUS. Although the HTSUS numbers are provided for convenience and customs purposes, the written product description remains dispositive.
Because no party submitted a case brief in response to the Department's
Based on these final results, we will instruct U.S. Customs and Border Protection to suspend liquidation and collect estimated antidumping duties for all shipments of subject merchandise exported by AMM and entered, or withdrawn from warehouse, for consumption on or after the publication of this notice in the
This notice serves as a final reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.
We are issuing and publishing these final results in accordance with sections 751(b) and 777(i) of the Act, and 19 CFR 351.216.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) preliminarily determines that certain tool chests and cabinets (tool chests) from the People's Republic of China (the PRC) are being, or are likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is October 1, 2016, through March 31, 2017.
Applicable November 16, 2017.
Yang Jin Chun or Andre Gziryan, AD/CVD Operations Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-5760 and (202) 482-2201, respectively.
This preliminary determination is made in accordance with section 733(b)
The products covered by this investigation are tool chests from the PRC. For a complete 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. The Department has calculated export prices and constructed export prices in accordance with sections 772(a) and (b) of the Act, respectively. Because the PRC is a non-market economy, within the meaning of section 771(18) of the Act, the Department has calculated normal value (NV) in accordance with section 773(c) of the Act. In addition, pursuant to section 776(a) and (b) of the Act, the Department preliminarily has relied on facts otherwise available, with adverse inferences, for the PRC-wide entity. For a full description of the methodology underlying the Department's preliminary determination,
In the
The Department preliminarily determines that the following estimated weighted-average dumping margins exist:
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 subject merchandise 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
To determine the cash deposit rate, the Department normally adjusts the estimated weighted-average dumping margin by the amount of domestic subsidy pass-through and export subsidies determined in a companion CVD proceeding when CVD provisional measures are in effect. Accordingly, where the Department has made a preliminary affirmative determination for domestic subsidy pass-through or export subsidies, the Department has offset the calculated estimated weighted-average dumping margin by the appropriate rate(s). Any such adjusted rates may be found in the Preliminary Determination Section's chart of estimated weighted-average dumping margins above.
Should provisional measures in the companion CVD investigation expire prior to the expiration of provisional measures in this LTFV investigation, the Department will direct CBP to begin collecting cash deposits at a rate equal to the estimated weighted-average dumping margins calculated in this preliminary determination unadjusted for the passed-through domestic subsidies or for export subsidies at the time the CVD provisional measures expire.
These suspension of liquidation instructions will remain in effect until further notice.
The Department intends to disclose to interested parties the calculations performed in connection with this preliminary determination within five days of its public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
As provided in section 782(i)(1) of the Act, the Department intends to verify information relied upon in making its final determination.
Case briefs or other written comments, with the exception of scope case briefs or scope comments,
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
All documents must be filed electronically using ACCESS. An electronically-filed request must be received successfully in its entirety by ACCESS no later than 5:00 p.m. Eastern Time on the established due date.
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 the petitioners. Pursuant to 19 CFR 351.210(e)(2), the Department requires that requests by respondents for postponement of a final antidumping determination be accompanied by a request for extension of provisional
On October 6, 2017, pursuant to 19 CFR 351.210(e)(2), Geelong and the Tongrun Single Entity requested that the Department postpone the final determination and that provisional measures be extended to a period not to exceed six months.
In accordance with section 733(f) of the Act, the Department will notify the International Trade Commission (ITC) of its preliminary determination of sales at LTFV. If the 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 the final determination whether imports of the subject merchandise are materially injuring, or threaten material injury to, the U.S. industry.
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 scope of this investigation covers certain metal tool chests and tool cabinets, with drawers, (tool chests and cabinets), from the People's Republic of China (the PRC). The scope covers all metal tool chests and cabinets, including top chests, intermediate chests, tool cabinets and side cabinets, storage units, mobile work benches, and work stations and that have the following physical characteristics:
(1) A body made of carbon, alloy, or stainless steel and/or other metals;
(2) two or more drawers for storage in each individual unit;
(3) a width (side to side) exceeding 15 inches for side cabinets and exceeding 21 inches for all other individual units but not exceeding 60 inches;
(4) a body depth (front to back) exceeding 10 inches but not exceeding 24 inches; and
(5) prepackaged for retail sale.
For purposes of this scope, the width parameter applies to each individual unit,
Prepackaged for retail sale means the units may, for example, be packaged in a cardboard box, other type of container or packaging, and may bear a Universal Product Code, along with photographs, pictures, images, features, artwork, and/or product specifications. Subject tool chests and cabinets are covered whether imported in assembled or unassembled form. Subject merchandise includes tool chests and cabinets produced in the PRC but assembled, prepackaged for retail sale, or subject to other minor processing in a third country prior to importation into the United States. Similarly, it would include tool chests and cabinets produced in the PRC that are later found to be assembled, prepackaged for retail sale, or subject to other minor processing after importation into the United States.
Subject tool chests and cabinets may also have doors and shelves in addition to drawers, may have handles (typically mounted on the sides), and may have a work surface on the top. Subject tool chests and cabinets may be uncoated (
Subject tool chests and cabinets may be packaged as individual units or in sets. When packaged in sets, they typically include a cabinet with one or more chests that stack on top of the cabinet. Tool cabinets act as a base tool storage unit and typically have rollers, casters, or wheels to permit them to be moved more easily when loaded with tools. Work stations and mobile work benches are tool cabinets with a work surface on the top that may be made of rubber, plastic, metal, wood, or other materials.
Top chests are designed to be used with a tool cabinet to form a tool storage unit. The top chests may be mounted on top of the base tool cabinet or onto an intermediate chest. They are often packaged as a set with tool cabinets or intermediate chests, but may also be packaged separately. They may be packaged with mounting hardware (
Side cabinets are designed to be bolted or otherwise attached to the side of the base storage cabinet to expand the storage capacity of the base tool cabinet.
Subject tool chests and cabinets also may be packaged with a tool set included. Packaging a subject tool chest and cabinet with a tool set does not remove an otherwise covered subject tool chest and cabinet from the scope. When this occurs, the tools are not part of the subject merchandise.
All tool chests and cabinets that meet the above definition are included in the scope unless otherwise specifically excluded.
Excluded from the scope of the investigation are tool boxes, chests, and cabinets with bodies made of plastic, carbon fiber, wood, or other non-metallic substances.
Also excluded from the scope of the investigation are industrial grade steel tool chests and cabinets. The excluded industrial grade steel tool chests and cabinets are those:
(1) Having a body that is over 60 inches in width; or
(2) having each of the following physical characteristics:
(a) A body made of steel that is 0.047 inches or more in thickness;
(b) a body depth (front to back) exceeding 21 inches; and
(c) a unit weight that exceeds the maximum unit weight shown below for each width range:
Also excluded from the scope of the investigation are service carts. The excluded service carts have all of the following characteristics:
(1) Casters, wheels, or other similar devices which allow the service cart to be rolled from place to place;
(2) a flat top or flat lid on top of the unit that opens;
(3) a space or gap between the casters, wheels, or other similar devices, and the bottom of the enclosed storage space (
(4) a total unit height, including casters, of less than 48 inches.
Also excluded from the scope of the investigation are non-mobile work benches. The excluded non-mobile work benches have all of the following characteristics:
(1) A solid top working surface;
(2) no drawers, one drawer, or two drawers in a side-by-side configuration; and
(3) the unit is supported by legs and has no solid front, side, or back panels enclosing the body of the unit.
Also excluded from the scope of this investigation are metal filing cabinets that are configured to hold hanging file folders and are classified in the Harmonized Tariff Schedule of the United States (HTSUS) at subheading 9403.10.0020.
Merchandise subject to this investigation is classified under HTSUS categories 9403.20.0021, 9403.20.0026, 9403.20.0030 and 7326.90.8688, but may also be classified under HTSUS category 7326.90.3500. While HTSUS subheadings are provided for convenience and Customs purposes, the written description of the scope of this investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) determines that certain hardwood plywood products (hardwood plywood) from the People's Republic of China (PRC) are being, or is likely to be, sold in the United States at less than fair value (LTFV). The final weighted-average dumping margins for the investigation on hardwood plywood from the PRC are listed in the “Final Determination Margins” section of this notice.
Applicable November 16, 2017.
Amanda Brings or Ryan Mullen, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue
On June 23, 2017, the Department published its
The period of investigation (POI) is April 1, 2016 through September 30, 2016. This period corresponds to the two most recent fiscal quarters prior to the month of the filing of the petition, which was November 2016.
The scope of the investigation covers hardwood plywood from the PRC. For a complete description of the scope of the investigation,
All issues raised in the case and rebuttal briefs by parties in this investigation are addressed in either the Issues and Decision Memorandum or the Final Scope Decision Memorandum accompanying this notice, both of which are hereby adopted by this notice.
As provided in section 782(i) of the Tariff Act of 1930, as amended (the Act), in September 2017, the Department conducted verification of the information submitted by Linyi Chengen Import and Export Co., Ltd. (Chengen) for use in the final determination. We issued our verification report on September 29, 2017.
Based on our analysis of the comments received and our findings at verification, we have determined to apply the intermediate input methodology
For the reasons explained in the
In selecting the AFA rate for the PRC-wide entity, the Department's practice is to select a rate that is sufficiently adverse to ensure that the uncooperative party does not obtain a more favorable result by failing to cooperate than if it had fully cooperated.
Under section 735(c)(5)(A) of the Act, the all-others rate is normally an amount equal to the weighted average of the estimated weighted average dumping margins established for exporters and producers individually investigated, excluding any zero and
In this final determination, the Department has calculated a rate for Chengen that is not zero,
The Department determines that the estimated final weighted-average dumping margins are as follows:
We intend to
In accordance with section 735(c)(1)(B) of the Act, we will instruct U.S. Customs and Border Protection (CBP) to continue to suspend liquidation of all entries of hardwood plywood from the PRC, as described in the “Scope of the Investigation” section, entered, or withdrawn from warehouse, for consumption on or after June 23, 2017, the date of publication of the
Pursuant to section 735(c)(1)(B)(ii) of the Act, 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, with respect to Chengen, a mandatory respondent in this investigation not individually examined in the CVD investigation, and the separate-rate companies, we find that an export subsidy adjustment of 11.81 percent to the cash deposit rate is warranted because this is the export subsidy rate included in the countervailing duty “all others” rate to which the separate-rate companies are subject. As part of our determination in this final determiation to apply adverse facts available the PRC-wide entity (which includes Bayley), the Department has not adjusted the PRC-wide entity's AD cash deposit rate by the lowest export subsidy rate determined for any party in the companion CVD proceeding, because the lowest export subsidy rate determined in the companion CVD proceeding is 0.00 percent.
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.
In accordance with section 735(d) of the Act, we notified the International Trade Commission (ITC) of the final affirmative determination of sales at LTFV. As the Department's final determination is affirmative, in accordance with section 735(b)(2) of the Act, the ITC will determine, within 45 days, whether the domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports of hardwood plywood for sale from the PRC, or sales (or the likelihood of sales) for importation, of hardwood plywood from the PRC. If the ITC determines that such injury does not exist, this proceeding will be terminated and all securities posted will be refunded or canceled. If the ITC determines that such injury does exist, the Department will issue an antidumping duty order directing CBP to assess, upon further instruction by the Department, antidumping duties on all imports of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the effective date of the suspension of liquidation.
This notice also serves as a reminder to the parties subject to administrative protective order (APO) of their responsibility concerning the disposition of propriety information disclosed under APO in accordance with 19 CFR 351.305. Timely written notification of return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.
This determination is issued and published in accordance with sections 735(d) and 777(i)(1) of the Act.
The merchandise subject to this investigation is hardwood and decorative plywood, and certain veneered panels as described below. For purposes of this proceeding, hardwood and decorative plywood is defined as a generally flat, multilayered plywood or other veneered panel, consisting of two or more layers or plies of wood veneers and a core, with the face and/or back veneer made of non-coniferous wood (hardwood) or bamboo. The veneers, along with the core may be glued or otherwise bonded together. Hardwood and decorative plywood may include products that meet the American National Standard for Hardwood and Decorative Plywood, ANSI/HPVA HP-1-2016 (including any revisions to that standard).
For purposes of this investigation a “veneer” is a slice of wood regardless of thickness which is cut, sliced or sawed from a log, bolt, or flitch. The face and back veneers are the outermost veneer of wood on either side of the core irrespective of additional surface coatings or covers as described below.
The core of hardwood and decorative plywood consists of the layer or layers of one or more material(s) that are situated between the face and back veneers. The core may be composed of a range of materials, including but not limited to hardwood, softwood, particleboard, or medium-density fiberboard (MDF).
All hardwood plywood is included within the scope of this investigation regardless of whether or not the face and/or back veneers are surface coated or covered and whether or not such surface coating(s) or covers obscures the grain, textures, or markings of the wood. Examples of surface coatings and covers include, but are not limited to: Ultra violet light cured polyurethanes; oil or oil-modified or water based polyurethanes; wax; epoxy-ester finishes; moisture-cured urethanes; paints; stains; paper; aluminum; high pressure laminate; MDF; medium density overlay (MDO); and phenolic film. Additionally, the face veneer of hardwood plywood may be sanded; smoothed or given a “distressed” appearance through such methods as hand-scraping or wire brushing. All hardwood plywood is included within the scope even if it is trimmed; cut-to-size; notched; punched; drilled; or has underwent other forms of minor processing.
All hardwood and decorative plywood is included within the scope of this investigation, without regard to dimension (overall thickness, thickness of face veneer, thickness of back veneer, thickness of core, thickness of inner veneers, width, or length). However, the most common panel sizes of hardwood and decorative plywood are 1219 x 1829 mm (48 x 72 inches), 1219 x 2438 mm (48 x 96 inches), and 1219 x 3048 mm (48 x 120 inches).
Subject merchandise also includes hardwood and decorative plywood that has been further processed in a third country, including but not limited to trimming, cutting, notching, punching, drilling, or any other processing that would not otherwise remove the merchandise from the scope of the investigation if performed in the country of manufacture of the in-scope product.
The scope of the investigation excludes the following items: (1) Structural plywood (also known as “industrial plywood” or “industrial panels”) that is manufactured to meet U.S. Products Standard PS 1-09, PS 2-09, or PS 2-10 for Structural Plywood (including any revisions to that standard or any substantially equivalent international standard intended for structural plywood), and which has both a face and a back veneer of coniferous wood; (2) products which have a face and back veneer of cork; (3) multilayered wood flooring, as described in the antidumping duty and countervailing duty orders on Multilayered Wood Flooring from the People's Republic of China, Import Administration, International Trade Administration. See Multilayered Wood Flooring from the People's Republic of China, 76 FR 76690 (December 8, 2011) (amended final determination of sales at less than fair value and antidumping duty order), and Multilayered Wood Flooring from the People's Republic of China, 76 FR 76693 (December 8, 2011) (countervailing duty order), as amended by Multilayered Wood Flooring from the People's Republic of China: Amended Antidumping and Countervailing Duty Orders, 77 FR 5484 (February 3, 2012); (4) multilayered wood flooring with a face veneer of bamboo or composed entirely of bamboo; (5) plywood which has a shape or design other than a flat panel, with the exception of any minor processing described above; (6) products made entirely from bamboo and adhesives (also known as “solid bamboo”); and (7) Phenolic Film Faced Plyform (PFF), also known as Phenolic Surface Film Plywood (PSF), defined as a panel with an “Exterior” or “Exposure 1” bond classification as is defined by The Engineered Wood Association, having an opaque phenolic film layer with a weight equal to or greater than 90g/m3 permanently bonded on both the face and back veneers and an opaque, moisture resistant coating applied to the edges.
Excluded from the scope of this investigation are wooden furniture goods that, at the time of importation, are fully assembled and are ready for their intended uses. Also excluded from the scope of this investigation is “ready to assemble” (RTA) furniture. RTA furniture is defined as (A) furniture packaged for sale for ultimate purchase by an end-user that, at the time of importation, includes (1) all wooden components (in finished form) required to assemble a finished unit of furniture, (2) all accessory parts (
Excluded from the scope of this investigation are kitchen cabinets that, at the time of importation, are fully assembled and are ready for their intended uses. Also excluded from the scope of this investigation are RTA kitchen cabinets. RTA kitchen cabinets are defined as kitchen cabinets packaged for sale for ultimate purchase by an end-user that, at the time of importation, includes (1) all wooden components (in finished form) required to assemble a finished unit of cabinetry, (2) all accessory parts (
Excluded from the scope of this investigation are finished table tops, which are table tops imported in finished form with pre-cut or drilled openings to attach the underframe or legs. The table tops are ready for use at the time of import and require no further finishing or processing.
Excluded from the scope of this investigation are finished countertops that are imported in finished form and require no further finishing or manufacturing.
Excluded from the scope of this investigation are laminated veneer lumber door and window components with (1) a maximum width of 44 millimeters, a thickness from 30 millimeters to 72 millimeters, and a length of less than 2413 millimeters (2) water boiling point exterior adhesive, (3) a modulus of elasticity of 1,500,000 pounds per square inch or higher, (4) finger-jointed or lap-jointed core veneer with all layers oriented so that the grain is running parallel or with no more than 3 dispersed layers of veneer oriented with the grain running perpendicular to the other layers; and (5) top layer machined with a curved edge and one or more profile channels throughout.
Imports of hardwood plywood are primarily entered under the following Harmonized Tariff Schedule of the United States (HTSUS) subheadings: 4412.10.0500; 4412.31.0520; 4412.31.0540; 4412.31.0560; 4412.31.0620; 4412.31.0640; 4412.31.0660; 4412.31.2510; 4412.31.2520; 4412.31.2610; 4412.31.2620; 4412.31.4040; 4412.31.4050; 4412.31.4060; 4412.31.4075; 4412.31.4080; 4412.31.4140; 4412.31.4150; 4412.31.4160; 4412.31.4180; 4412.31.5125; 4412.31.5135; 4412.31.5155; 4412.31.5165; 4412.31.5175; 4412.31.5235; 4412.31.5255; 4412.31.5265; 4412.31.5275; 4412.31.6000; 4412.31.6100;
Imports of hardwood plywood may also enter under HTSUS subheadings 4412.99.6000; 4412.99.7000; 4412.99.8000; 4412.99.9000; 4412.10.9000; 4412.94.5100; 4412.94.9500; and 4412.99.9500. While the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Department) determines that countervailable subsidies are being provided to producers and exporters of biodiesel from the Republic of Indonesia (Indonesia). The period of investigation is January 1, 2016, through December 31, 2016.
Appicable November 16, 2017.
Joseph Traw or Gene Calvert, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone (202) 482-6079 or (202) 482-3586, respectively.
The Department published the
The period of investigation for which we are measuring subsidies is January 1, 2016, through December 31, 2016.
The product covered by this investigation is biodiesel from Indonesia. For a complete description of the scope of this investigation,
The subsidy programs under investigation, and the issues raised in the case and rebuttal briefs submitted by the interested parties in this proceeding, are discussed in the Final Decision Memorandum. A list of the issues raised by the parties and responded to by the Department in the Final Decision Memorandum, is attached at Appendix I to this notice.
As provided in section 782(i) of the Tariff Act of 1930, as amended (the Act), during September 2017, the Department verified the subsidy information reported by the Government of Indonesia, PT Musim Mas (Musim Mas), and Wilmar Trading Co., Ltd. (Wilmar Trading). We used standard verification procedures, including an examination of relevant accounting records and original source documents provided by the respondents.
Based on our analysis of the comments received from parties and the minor corrections presented, we made certain changes to the respondents' subsidy rate calculations set forth in the
In accordance with section 705(c)(1)(B)(i)(I) of the Act, the Department calculated a countervailable subsidy rate for the individually investigated exporters/producers of the subject merchandise. Consistent with sections 705(c)(1)(B)(i)(I) and 705(c)(5)(A) of the Act, the Department also calculated an estimated “all-others” rate for exporters and producers not individually investigated. Section 705(c)(5)(A)(i) of the Act provides that the “all-others” rate shall be an amount equal to the weighted-average of the countervailable subsidy rates established for individually investigated exporters and producers, excluding any rates that are zero or
In accordance with section 705(c)(1)(B)(i)(I) of the Act, we established individual estimated countervailable subsidy rates for PT Musim Mas and Wilmar Trading Co., Ltd., and their cross-owned entities.
The Department will disclose the calculations performed within five days of the date of publication of this notice to parties in this proceeding in accordance with 19 CFR 351.224(b).
In accordance with sections 703(d) of the Act, the Department will instruct U.S. Customs and Border Protection (CBP) to continue to suspend liquidation of all appropriate entries of biodiesel from Indonesia, which were entered, or withdrawn from warehouse, for consumption on or after August 28, 2017, the date of publication of the
In accordance with section 705(d) of the Act, we will notify the U.S. International Trade Commission (ITC) of the final affirmative determination of countervailable subsidies. Because the final determination in this proceeding is affirmative, in accordance with section 705(b) of the Act, the ITC will make its final determination as to whether the domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports of biodiesel from Indonesia no later than 45 days after our final determination. If the ITC determines that material injury or threat of material injury does not exist, the proceeding will be terminated and all cash deposits will be refunded. If the ITC determines that such injury does exist, the Department will issue a CVD order directing CBP to assess, upon further instruction by the Department, countervailing duties on all imports of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the effective date of the suspension of liquidation, as discussed above in the “Continuation of Suspension of Liquidation” section.
In the event the ITC issues a final negative injury determination, this notice serves as the only reminder to parties subject to an APO of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation subject to sanction.
This determination is issued and published pursuant to sections 705(d) and 777(i) of the Act.
The product covered by this investigation is biodiesel, which is a fuel comprised of mono-alkyl esters of long chain fatty acids derived from vegetable oils or animal fats, including biologically-based waste oils or greases, and other biologically-based oil or fat sources. The investigations cover biodiesel in pure form (B100) as well as fuel mixtures containing at least 99 percent biodiesel by volume (B99). For fuel mixtures containing less than 99 percent biodiesel by volume, only the biodiesel component of the mixture is covered by the scope of the investigation.
Biodiesel is generally produced to American Society for Testing and Materials International (ASTM) D6751 specifications, but it can also be made to other specifications. Biodiesel commonly has one of the following Chemical Abstracts Service
The B100 product subject to the investigation is currently classifiable under subheading 3826.00.1000 of the Harmonized Tariff Schedule of the United States (HTSUS), while the B99 product is currently classifiable under HTSUS subheading 3826.00.3000. Although the HTSUS subheadings, ASTM specifications, and CAS numbers are provided for convenience and customs purposes, the written description of the scope is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Department) determines that countervailable subsidies are being provided to producers and exporters of certain hardwood plywood products (hardwood plywood) from the People's Republic of China (PRC). The period of investigation is January 1, 2015, through December 31, 2015. For information on the estimated subsidy rates, see the “Suspension of Liquidation” section of this notice.
Applicable November 16, 2017.
Matthew Renkey or Justin Neuman, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone 202.482.2312 or 202.482.0486, respectively.
The petitioner in this investigation is the Coalition for Fair Trade in Hardwood Plywood and its individual members, Columbia Forest Products, Commonwealth Plywood Inc., Murphy Plywood, Roseburg Forest Products Co., States Industries, Inc., and Timber Products Company (the petitioners). In addition to the Government of China (GOC), the mandatory respondents in this investigation are Linyi Sanfortune Wood Co., Ltd. (Sanfortune) and Dongfang Bayley Wood Co., Ltd. (Bayley Wood). The Department has determined that Bayley Wood is cross-owned with Linyi Yinhe Panel Factory, a producer of subject merchandise, and will refer to them collectively as “Bayley Wood.”
The Department published its
The Department is conducting this countervailing duty (CVD) investigation in accordance with section 701 of the Tariff Act of 1930, as amended (Act). For each of the subsidy programs found to be countervailable, we determine that there is a subsidy (
The product covered by this investigation is hardwood plywood from the PRC. For a complete description of the scope of this investigation,
All issues raised in the comments filed by interested parties to this proceeding are discussed in the Issues and Decision Memorandum. A list of the issues raised by interested parties and responded to by the Department in the Issues and Decisions Memorandum are attached at Appendix I to this notice.
For purposes of this final determination, we relied on facts available, and because certain respondents did not act to the best of their ability in responding to the Department's requests for information, we drew an adverse inference, where appropriate, in selecting from among the facts otherwise available.
Based on our review and analysis of the comments received from parties, and minor corrections accepted at verification, we made certain changes to the respondents' subsidy rate calculations since the
In the
In accordance with section 705(c)(1)(B)(i)(I) of the Act, we calculated an estimated individual countervailable subsidy rate for each producer/exporter of the subject merchandise individually investigated.
In accordance with section 705(c)(5)(A) of the Act, for companies not individually investigated, we applied an “all-others” rate, which is normally calculated by weighting the subsidy rates of the individual companies selected as mandatory respondents by those companies' exports of the subject merchandise to the United States. Under section 705(c)(5)(A)(i) of the Act, the all-others rate excludes zero and
We intend to
As a result of our
The Department continues to find that critical circumstances exist for those companies receiving AFA (
In accordance with the preliminary affirmative determination of critical circumstances, we instructed CBP to suspend liquidation of all entries of the subject merchandise from “all other” producers and exporters, which were entered or withdrawn from warehouse, on or after January 25, 2017, which is 90 days prior to April 25, 2017, the date of publication of the
If the U.S. International Trade Commission (ITC) issues a final affirmative injury determination, we will issue a CVD order and reinstate the suspension of liquidation under section 706(a) of the Act, requiring a cash deposit of estimated CVDs for such entries of subject merchandise in the amounts indicated above. If the ITC determines that material injury, or threat of material injury, does not exist, this proceeding will be terminated and all estimated duties deposited or securities posted as a result of the suspension of liquidation will be refunded or canceled.
In accordance with section 705(d) of the Act, we will notify the ITC of our determination. In addition, we are making available to the ITC all non-privileged and non-proprietary information relating to this investigation. We will allow the ITC access to all privileged and business proprietary information in our files, provided the ITC confirms that it will not disclose such information, either publicly or under an administrative protective order (APO), without the written consent of the Assistant Secretary for Enforcement and Compliance.
In the event that the ITC issues a final negative injury determination, this notice will serve as the only reminder to parties subject to an APO of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or, alternatively, conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation that is subject to sanction.
This determination is published pursuant to sections 705(d) and 777(i) of the Act.
The merchandise subject to this investigation is hardwood and decorative plywood, and certain veneered panels as described below. For purposes of this proceeding, hardwood and decorative plywood is defined as a generally flat, multilayered plywood or other veneered panel, consisting of two or more layers or plies of wood veneers and a core, with the face and/or back veneer made of non-coniferous wood (hardwood) or bamboo. The veneers, along with the core may be glued or otherwise bonded together. Hardwood and decorative plywood may include products that meet the American National Standard for Hardwood and Decorative Plywood, ANSI/HPVA HP-1-2016 (including any revisions to that standard).
For purposes of this investigation a “veneer” is a slice of wood regardless of thickness which is cut, sliced or sawed from a log, bolt, or flitch. The face and back veneers are the outermost veneer of wood on either side of the core irrespective of additional surface coatings or covers as described below.
The core of hardwood and decorative plywood consists of the layer or layers of one or more material(s) that are situated between the face and back veneers. The core may be composed of a range of materials, including but not limited to hardwood, softwood, particleboard, or medium-density fiberboard (MDF).
All hardwood plywood is included within the scope of this investigation regardless of whether or not the face and/or back veneers are surface coated or covered and whether or not such surface coating(s) or covers obscures the grain, textures, or markings of the wood. Examples of surface coatings and covers include, but are not limited to: Ultra violet light cured polyurethanes; oil or oil-modified or water based polyurethanes; wax; epoxy-ester finishes; moisture-cured urethanes; paints; stains; paper; aluminum; high pressure laminate; MDF; medium density overlay (MDO); and phenolic film. Additionally, the face veneer of hardwood plywood may be sanded; smoothed or given a “distressed” appearance through such methods as hand-scraping or wire brushing. All hardwood plywood is included within the scope even if it is trimmed; cut-to-size; notched; punched; drilled; or has underwent other forms of minor processing.
All hardwood and decorative plywood is included within the scope of this investigation, without regard to dimension (overall thickness, thickness of face veneer, thickness of back veneer, thickness of core, thickness of inner veneers, width, or length). However, the most common panel sizes of hardwood and decorative plywood are 1219 x 1829 mm (48 x 72 inches), 1219 x 2438 mm (48 x 96 inches), and 1219 x 3048 mm (48 x 120 inches).
Subject merchandise also includes hardwood and decorative plywood that has been further processed in a third country, including but not limited to trimming, cutting, notching, punching, drilling, or any other processing that would not otherwise remove the merchandise from the scope of the investigation if performed in the country of manufacture of the in-scope product.
The scope of the investigation excludes the following items: (1) Structural plywood (also known as “industrial plywood” or “industrial panels”) that is manufactured to meet U.S. Products Standard PS 1-09, PS 2-09, or PS 2-10 for Structural Plywood (including any revisions to that standard or any substantially equivalent international standard intended for structural plywood), and which has both a face and a back veneer of coniferous wood; (2) products which have a face and back veneer of cork; (3) multilayered wood flooring, as described in the antidumping duty and countervailing duty orders on Multilayered Wood Flooring from the People's Republic of China, Import Administration, International Trade Administration. See Multilayered Wood Flooring from the People's Republic of China, 76 FR 76690 (December 8, 2011) (amended final determination of sales at less than fair value and antidumping duty order), and Multilayered Wood Flooring from the People's Republic of China, 76 FR 76693 (December 8, 2011) (countervailing duty order), as amended by Multilayered Wood Flooring from the People's Republic of China: Amended Antidumping and Countervailing Duty Orders, 77 FR 5484 (February 3, 2012); (4) multilayered wood flooring with a face veneer of bamboo or composed entirely of bamboo; (5) plywood which has a shape or design other than a flat panel, with the exception of any minor processing described above; (6) products made entirely from bamboo and adhesives (also known as “solid bamboo”); and (7) Phenolic Film Faced Plyform (PFF), also known as Phenolic Surface Film Plywood (PSF), defined as a panel with an “Exterior” or “Exposure 1” bond classification as is defined by The Engineered Wood Association, having an opaque phenolic film layer with a weight equal to or greater than 90g/m3 permanently bonded on both the face and back veneers and an opaque, moisture resistant coating applied to the edges.
Excluded from the scope of this investigation are wooden furniture goods that, at the time of importation, are fully assembled and are ready for their intended uses. Also excluded from the scope of this investigation is “ready to assemble” (RTA) furniture. RTA furniture is defined as (A) furniture packaged for sale for ultimate purchase by an end-user that, at the time of importation, includes (1) all wooden components (in finished form) required to assemble a finished unit of furniture, (2) all accessory parts (
Excluded from the scope of this investigation are kitchen cabinets that, at the time of importation, are fully assembled and are ready for their intended uses. Also excluded from the scope of this investigation are RTA kitchen cabinets. RTA kitchen cabinets are defined as kitchen cabinets packaged for sale for ultimate purchase by an
Excluded from the scope of this investigation are finished table tops, which are table tops imported in finished form with pre-cut or drilled openings to attach the underframe or legs. The table tops are ready for use at the time of import and require no further finishing or processing.
Excluded from the scope of this investigation are finished countertops that are imported in finished form and require no further finishing or manufacturing.
Excluded from the scope of this investigation are laminated veneer lumber door and window components with (1) a maximum width of 44 millimeters, a thickness from 30 millimeters to 72 millimeters, and a length of less than 2413 millimeters (2) water boiling point exterior adhesive, (3) a modulus of elasticity of 1,500,000 pounds per square inch or higher, (4) finger-jointed or lap-jointed core veneer with all layers oriented so that the grain is running parallel or with no more than 3 dispersed layers of veneer oriented with the grain running perpendicular to the other layers; and (5) top layer machined with a curved edge and one or more profile channels throughout.
Imports of hardwood plywood are primarily entered under the following Harmonized Tariff Schedule of the United States (HTSUS) subheadings: 4412.10.0500; 4412.31.0520; 4412.31.0540; 4412.31.0560; 4412.31.0620; 4412.31.0640; 4412.31.0660; 4412.31.2510; 4412.31.2520; 4412.31.2610; 4412.31.2620; 4412.31.4040; 4412.31.4050; 4412.31.4060; 4412.31.4075; 4412.31.4080; 4412.31.4140; 4412.31.4150; 4412.31.4160; 4412.31.4180; 4412.31.5125; 4412.31.5135; 4412.31.5155; 4412.31.5165; 4412.31.5175; 4412.31.5235; 4412.31.5255; 4412.31.5265; 4412.31.5275; 4412.31.6000; 4412.31.6100; 4412.31.9100; 4412.31.9200; 4412.32.0520; 4412.32.0540; 4412.32.0565; 4412.32.0570; 4412.32.0620; 4412.32.0640; 4412.32.0670; 4412.32.2510; 4412.32.2525; 4412.32.2530; 4412.32.2610; 4412.32.2630; 4412.32.3125; 4412.32.3135; 4412.32.3155; 4412.32.3165; 4412.32.3175; 4412.32.3185; 4412.32.3235; 4412.32.3255; 4412.32.3265; 4412.32.3275; 4412.32.3285; 4412.32.5600; 4412.32.3235; 4412.32.3255; 4412.32.3265; 4412.32.3275; 4412.32.3285; 4412.32.5700; 4412.94.1030; 4412.94.1050; 4412.94.3105; 4412.94.3111; 4412.94.3121; 4412.94.3141; 4412.94.3161; 4412.94.3175; 4412.94.4100; 4412.99.0600; 4412.99.1020; 4412.99.1030; 4412.99.1040; 4412.99.3110; 4412.99.3120; 4412.99.3130; 4412.99.3140; 4412.99.3150; 4412.99.3160; 4412.99.3170; 4412.99.4100; 4412.99.5115; and 4412.99.5710.
Imports of hardwood plywood may also enter under HTSUS subheadings 4412.99.6000; 4412.99.7000; 4412.99.8000; 4412.99.9000; 4412.10.9000; 4412.94.5100; 4412.94.9500; and 4412.99.9500. While the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Department) determines that countervailable subsidies are being provided to producers and exporters of biodiesel from the Republic of Argentina. The period of investigation is January 1, 2016, through December 31, 2016.
Applicable November 16, 2017.
Kathryn Wallace or Elfi Blum, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-6251, or (202) 482-0197, respectively.
The Department published the
The period of investigation for which we are measuring subsidies is January 1, 2016, through December 31, 2016.
The scope of the investigation covers biodiesel from the Republic of Argentina. The Department did not receive any scope comments and has not updated the scope of the investigation since the
In the
The subsidy programs under investigation, and the issues raised in the case and rebuttal briefs submitted by the interested parties in this proceeding, are discussed in the Final Decision Memorandum. A list of the issues raised by the parties and addressed by the
As provided in section 782(i) of the Act, during September 2017, the Department verified the subsidy information reported by the Government of Argentina (GOA), LDC Argentina, and Vicentin. We used standard verification procedures, including an examination of relevant accounting records and original source documents provided by the respondents.
If necessary information is not available on the record, or an interested party withholds information, fails to provide requested information in a timely manner, significantly impedes a proceeding by not providing information, or information provided cannot be verified, the Department will apply facts available, pursuant to section 776(a)(1) & (2) of the Act.
For purposes of this final determination, the Department continued to rely, in part, on facts available. For the GOA and Vicentin,
For further information on the Department's application of AFA, as summarized above,
Based on our analysis of the comments received from parties and the minor corrections presented, we made certain changes to the respondents' subsidy rate calculations set forth in the
In accordance with section 705(c)(1)(B)(i)(I) of the Act, the Department calculated a countervailable subsidy rate for the individually investigated exporters/producers of the subject merchandise. Consistent with sections 705(c)(1)(B)(i)(I) and 705(c)(5)(A) of the Act, the Department also calculated an estimated “all-others” rate for exporters and producers not individually investigated. Section 705(c)(5)(A)(i) of the Act provides that the “all-others” rate shall be an amount equal to the weighted-average of the countervailable subsidy rates established for individually investigated exporters and producers, excluding any rates that are zero or
The Department determines the total estimated countervailable subsidy rates to be:
The Department will disclose the calculations performed within five days of the date of publication of this notice to parties in this proceeding in accordance with 19 CFR 351.224(b).
In accordance with sections 703(d) of the Act, the Department will instruct U.S. Customs and Border Protection (CBP) to continue to suspend liquidation of all appropriate entries of biodiesel from Argentina, which were entered, or withdrawn from warehouse, for consumption on or after August 28, 2017, the date of publication of the
In accordance with section 705(d) of the Act, we will notify the U.S. International Trade Commission (ITC) of the final affirmative determination of countervailable subsidies. Because the final determination in this proceeding is affirmative, in accordance with section 705(b) of the Act, the ITC will make its final determination as to whether the domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports of biodiesel from Argentina no later than 45 days after our final determination. If the ITC determines that material injury or threat of material injury does not exist, the proceeding will be terminated and all cash deposits will be refunded. If the ITC determines that such injury does exist, the Department will issue a CVD order directing CBP to assess, upon further instruction by the Department, countervailing duties on all imports of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the effective date of the suspension of liquidation, as discussed above in the “Continuation of Suspension of Liquidation” section.
This notice serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a violation subject to sanction.
This determination is issued and published in accordance with sections 705(d) and 777(i) of the Act.
The product covered by this investigation is biodiesel, which is a fuel comprised of mono-alkyl esters of long chain fatty acids derived from vegetable oils or animal fats, including biologically-based waste oils or greases, and other biologically-based oil or fat sources. The investigation covers biodiesel in pure form (B100) as well as fuel mixtures containing at least 99 percent biodiesel by volume (B99). For fuel mixtures containing less than 99 percent biodiesel by volume, only the biodiesel component of the mixture is covered by the scope of the investigation.
Biodiesel is generally produced to American Society for Testing and Materials International (ASTM) D6751 specifications, but it can also be made to other specifications. Biodiesel commonly has one of the following Chemical Abstracts Service (CAS) numbers, generally depending upon the feedstock used: 67784-80-9 (soybean oil methyl esters); 91051-34-2 (palm oil methyl esters); 91051-32-0 (palm kernel oil methyl esters); 73891-99-3 (rapeseed oil methyl esters); 61788-61-2 (tallow methyl esters); 68990-52-3 (vegetable oil methyl esters); 129828-16-6 (canola oil methyl esters); 67762-26-9 (unsaturated alkylcarboxylic acid methyl ester); or 68937-84-8 (fatty acids, C12-C18, methyl ester).
The B100 product subject to the investigation is currently classifiable under subheading 3826.00.1000 of the Harmonized Tariff Schedule of the United States (HTSUS), while the B99 product is currently classifiable under HTSUS subheading 3826.00.3000. Although the HTSUS subheadings, ASTM specifications, and CAS numbers are provided for convenience and customs purposes, the written description of the scope is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Applicable November 16, 2017.
Catherine Cartsos at (202) 482-1757, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230.
On July 12, 2017, the Department of Commerce (the Department) initiated a less-than-fair-value (LTFV) investigation of imports of ripe olives from Spain.
Section 733(b)(1)(A) of the Tariff Act of 1930, as amended (the Act), requires the Department to issue the preliminary determination in a LTFV investigation within 140 days after the date on which the Department initiated the investigation. However, section 733(c)(1)(A)(b)(1) of the Act permits the Department to postpone the preliminary determination until no later than 190 days after the date on which the Department initiated the investigation if: (A) The petitioner
On October 11, 2017, the petitioner submitted a timely request that the Department postpone the preliminary determination in the LTFV investigation.
For the reasons stated above and because there are no compelling reasons to deny the request, the Department, in accordance with section 733(c)(1)(A) of the Act, is postponing the deadline for the preliminary determination by 50 days (
This notice is issued and published pursuant to section 733(c)(2) of the Act and 19 CFR 351.205(f)(1).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; request for comments.
NMFS has determined that twelve exempted fishing permit (EFP) applications warrant further consideration and is requesting public comment on the applications. All EFP applicants request an exemption from a single prohibition (the use of unauthorized gear to harvest HMS) under the Fishery Management Plan for U.S. West Coast Fisheries for Highly Migratory Species (HMS FMP) to test the effects and efficacy of using deep-set buoy gear (DSBG) and deep-set linked buoy gear (DSLBG) to harvest swordfish and other highly migratory species (HMS) off of the U.S. West Coast.
Comments must be submitted in writing by December 18, 2017.
You may submit comments on this document, identified by NOAA-NMFS-2017-0130, by any of the following methods:
•
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Chris Fanning, NMFS, West Coast Region, 562-980-4198.
DSBG fishing trials have occurred for the past seven years (2011-2015, research years; 2015-2017, EFP years) in the U.S. West Coast Exclusive Economic Zone (EEZ) off California. The data collected from this fishing activity have demonstrated DSBG to achieve about a 95% marketable catch composition (75% swordfish, 3% opah, and 17% marketable sharks). Non-marketable catch rates have remained low and all non-marketable catch were released alive. Due to DSBG being actively tended, strikes are capable of being detected within minutes of a hook on the line; as a result, all catches can be tended quickly, with catch brought onboard the vessel in good condition. To date, DSBG has had two interactions with protected species, both elephant seals which were not seriously injured and were released alive due to the strike detection of the gear. These species are protected by the Marine Mammal Protection Act, but are not listed as threatened or endangered under the Endangered Species Act.
DSLBG trials produced similar data to DSBG activities with DSLBG fishing activity occurring over a 40-day period in 2015-2016. Swordfish and other marketable species have represented about 90% of the catch (68% swordfish, 2% opah, 5% escolar, and 16% marketable sharks). Non-marketable species are released alive due to quick DSLBG strike detection and active gear tending. Fishing is still occurring with DSLBG; however, no reports have been submitted from the 2016-2017 year. To date, there have been no interactions with protected species using DSLBG.
At its September 2017 meeting, the Pacific Fishery Management Council (Council) received twelve additional applications for EFPs in time for review and recommended that NMFS consider issuing these EFPs to authorize use of DSBG and/or DSLBG (see Table 1).
NMFS is requesting public comment on the twelve applications recommended for issuance by the Council. If all applications were approved, the EFPs would allow up to thirteen vessels to fish with DSBG and four vessels to fish with DSLBG, throughout the duration of each EFP, in the U.S. West Coast EEZ with permitted exemption from the prohibitions of the
NMFS will consider all public comments submitted in response to this
16 U.S.C. 1801
Bureau of Consumer Financial Protection.
Notice regarding charges for certain disclosures under the Fair Credit Reporting Act.
The Bureau of Consumer Financial Protection (Bureau) announces that the ceiling on allowable charges under the Fair Credit Reporting Act (FCRA) will remain unchanged at $12.00, effective for 2018. The Bureau is required to increase the $8.00 amount referred to in the FCRA on January 1 of each year, based proportionally on changes in the Consumer Price Index for All Urban Consumers (CPI-U), with fractional changes rounded to the nearest fifty cents. The CPI-U increased 53.11 percent between September 1997, when the FCRA amendments took effect, and September 2017. This increase in the CPI-U, and the requirement that any increase be rounded to the nearest fifty cents, result in a maximum allowable charge of $12.00.
Effective January 1, 2018.
Monique Chenault, Paralegal Specialist, Office of Regulations, Consumer Financial Protection Bureau, 1700 G Street NW., Washington, DC 20552, at (202) 435-7700.
Section 612(f)(1)(A) of the Fair Credit Reporting Act (FCRA) provides that a consumer reporting agency may charge a consumer a reasonable amount for making a disclosure to the consumer pursuant to section 609 of the FCRA. Section 612(f)(1)(A) of the FCRA provides that, where a consumer reporting agency is permitted to impose a reasonable charge on a consumer for making a disclosure to the consumer pursuant to section 609 of the FCRA, the charge shall not exceed $8.00 and shall be indicated to the consumer before making the disclosure. Section 612(f)(2) of the FCRA states that the Bureau shall increase the $8.00 maximum amount on January 1 of each year, based proportionally on changes in the Consumer Price Index, with fractional changes rounded to the nearest fifty cents. The Bureau's calculations are based on the CPI-U, which is the most general Consumer Price Index and covers all urban consumers and all items.
Section 612(a) of the FCRA gives consumers the right to a free disclosure upon request once every 12 months. The maximum allowable charge established by this notice does not apply to requests made under that provision. The charge does apply when a consumer who orders a file disclosure has already received a free annual disclosure and does not otherwise qualify for an additional free disclosure.
The Bureau is using the $8.00 amount set forth in section 612(f)(1)(A)(i) of the FCRA as the baseline for its calculation of the increase in the ceiling on reasonable charges for certain disclosures made under section 609 of the FCRA. Since the effective date of section 612(a) was September 30, 1997, the Bureau calculated the proportional increase in the CPI-U from September
Between September 1997 and September 2017, the CPI-U increased by 53.11 percent from an index value of 161.2 in September 1997 to a value of 246.8 in September 2017. An increase of 53.11 percent in the $8.00 base figure would lead to a figure of $12.25. However, because the statute directs that the resulting figure be rounded to the nearest $0.50, the maximum allowable charge is $12.00. The Bureau therefore determines that the maximum allowable charge for the year 2018 will remain at $12.00, effective January 1, 2018.
Bureau of Consumer Financial Protection.
Notice of final language access plan.
Consistent with Executive Order 13166 (Aug. 11, 2000), the Consumer Financial Protection Bureau (Bureau or CFPB) is committed to providing persons with limited English proficiency (LEP) meaningful access to its programs and services. The Language Access Plan describes the Bureau's policy and how the Bureau's language access activities are implemented across the Bureau's operations, programs, and services.
This information is current as of November 13, 2017.
For general inquiries or any additional information, please contact Monica Jackson, Office of the Executive Secretary, at 202-435-7275. For information about the Final Language Access Plan, please contact Meina Banh, Office of Financial Education, at 202-435-7892.
The Dodd-Frank Wall Street Reform and Consumer Protection Act
Listening and responding to consumers is central to the Bureau's purpose of ensuring that all consumers have access to consumer financial products and services. Since its inception, the Bureau has provided consumers with numerous ways to make their voices heard. Consumers nationwide have engaged with the Bureau through public field hearings, listening events, roundtables, town halls, online through the Web site ConsumerFinance.gov, and through the Bureau's Office of Consumer Response. The Bureau has also sought input from a range of stakeholders, including financial educators, community-based organizations, financial institutions, and others about challenges that consumers face, effective approaches to overcoming those challenges, and what the Bureau can do to improve the financial decision-making process of consumers to help them better navigate the marketplace of financial products and services to reach their own goals.
This engagement would be incomplete without efforts to include limited English proficiency (LEP) persons. More than 65 million people, or about 21 percent of the U.S. population over the age of five, speak a language other than English at home.
The Federal Deposit Insurance Corporation's (FDIC) biennial survey on unbanked and underbanked households consistently shows that households where Spanish is the only language spoken were unbanked at five times the rate of households where Spanish is not the only language spoken.
Consistent with Executive Order 13166 and the Bureau's mission, the Bureau adopts this Final Language Access Plan to provide LEP individuals meaningful access to the Bureau's services.
On October 8, 2014, the CFPB released a Proposed Language Access Plan for public comment.
The Bureau considered the comments it received. Since the release of the Proposed Language Access Plan, the Bureau has made a number of additional efforts to provide LEP consumers meaningful access to information produced by the Bureau. The final plan is also informed by those efforts. The Bureau considered the following factors in drafting this Final Language Access Plan: (1) The number or proportion of LEP persons who would not receive the Bureau's services without efforts to remove language barriers; (2) the frequency and number of contacts by LEP persons with the Bureau's services; (3) the nature and importance of the services provided by the Bureau to people's financial lives; and (4) the resources available to the Bureau to provide services to LEP persons. Under the Language Access Plan, the Bureau provides LEP individuals access to information, services, activities, and programs by translating consumer-facing documents into select foreign languages and handling complaints from consumers about consumer financial products and services in more than 180 languages.
The Bureau has created a Language Access Task Force, an internal cross-divisional working group aimed at developing and executing a Bureau-wide strategy to provide LEP consumers meaningful access to information produced by the Bureau. The Language Access Task Force coordinates internally, ensures consistency within the Bureau in its communications with LEP individuals, and informs the Bureau's work to engage with LEP consumers.
The Bureau's Office of Consumer Response hears directly from consumers about the challenges they face in the marketplace and brings consumers' concerns to the attention of consumer financial product or service providers. The Office of Consumer Response currently accepts complaints about a wide variety of financial products and services and can assist consumers with complaints in more than 180 languages. Consumers have the choice to receive written communications in Spanish. The Bureau may also refer consumers to other regulators and resources, as needed.
The Bureau utilizes translation and interpretation services, as appropriate, during the course of supervisory examinations and enforcement investigations. The Bureau may utilize these services when conducting interviews and consulting with LEP consumer witnesses, whistleblowers, and employees of regulated entities; when reviewing non-English documents and telephone call recordings; and when providing information to the public on matters that may affect LEP consumers, as appropriate.
One of the Bureau's goals is to give consumers practical, actionable information that they can use in pursuing their own financial goals and in making financial decisions. The Bureau offers information and tools to help consumers build the financial knowledge and skills that they need to make well-informed financial decisions for themselves and their families to serve their own financial goals. For the LEP community, this includes access in consumers' native languages to consumer financial education materials. The Bureau offers this information directly through its Web site and its Spanish-translated Web site and has also made it available to LEP consumers through community service channels and at community roundtables throughout the country.
The Bureau offers free printed financial education materials translated into various languages for LEP consumers, which are distributed by both the Bureau and others who serve LEP consumers. To date, the CFPB has routinely translated its most frequently requested brochures into Spanish. Certain publications are also available in Chinese, French, Haitian Créole, Tagalog, Chinese, Korean, Vietnamese, Russian, and Arabic. For download or free bulk orders, interested persons can visit
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The Bureau's first substantive rule provided important new consumer protections to users of international money transfers, or remittances. Many of these users are LEP consumers who send money to family and friends abroad. The Bureau developed a comprehensive outreach and education campaign to educate consumers about the protections for remittance transfers. These materials are available in English, Spanish, Haitian Créole, Chinese, and Tagalog.
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The Bureau works with key stakeholders within LEP communities, such as community-based organizations, to help make the consumers they serve aware of the Bureau's resources and tools. The Bureau holds meetings with consumer groups, community service organizations, and financial institutions to discuss the challenges LEP consumers face.
Additional Bureau resources that can be utilized by all stakeholders include:
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A few of the Bureau's major rules address language access by, in accordance with pre-existing law, permitting required disclosures to be provided in a language other than English, as long as the disclosures are also made available in English.
This Language Access Plan articulates the Bureau's commitment to providing LEP persons with meaningful access to its programs and services. It is therefore exempt from the notice and comment rulemaking requirements under the Administrative Procedure Act.
Because no notice of proposed rulemaking is required, the Regulatory Flexibility Act does not require an initial or final regulatory flexibility analysis.
The Bureau has determined that this Language Access Plan does not impose any new or revise any existing recordkeeping, reporting, or disclosure requirements on covered entities or members of the public that would be collections of information requiring OMB approval under the Paperwork Reduction Act, 44 U.S.C. 3501-3521.
The text of the Final Language Access Plan follows:
Consistent with Executive Order 13166 (Aug. 11, 2000), this document establishes the Language Access Plan of the Consumer Financial Protection Bureau (the Bureau or CFPB) for providing meaningful access to the CFPB's services to limited English proficiency (LEP) persons (individuals who do not speak English as their primary language and who have a limited ability to speak, write, or understand English).
The CFPB is committed to the accessibility of its services to LEP persons. In developing this Language Access Plan, the CFPB engaged stakeholders in October 2014 by releasing a Proposed Language Access Plan for public comment to understand the opportunities to serve LEP persons and to ensure LEP individuals have access to the CFPB's programs and services.
To ensure meaningful access, the Bureau considers the following factors: (1) The number or proportion of LEP persons who would not receive the Bureau's services without efforts to remove language barriers; (2) the frequency and number of contacts by LEP persons with the Bureau's services; (3) the nature and importance of the services provided by the Bureau to people's financial lives; and (4) the resources available to the Bureau (including cost-benefit analysis) to provide services to LEP persons.
The CFPB provides LEP individuals with access to information, services, activities, and programs through the following activities:
The Bureau translates selected consumer-facing brochures into the most frequently encountered languages, as established by U.S. Census Bureau data or based on specific issues affecting a particular group of LEP individuals. The Bureau publishes a wider range of consumer-facing brochures in Spanish, which accounts for the second-largest language group in the United States. Translating public-facing brochures into the languages most frequently encountered is important when reaching LEP individuals.
The Bureau's Office of Consumer Response hears directly from consumers about the challenges they face in the marketplace and brings consumers' complaints to the attention of consumer financial product or service providers. The CFPB currently accepts complaints about a wide variety of financial products and services and can assist consumers with complaints in more than 180 languages. Consumers have the choice to receive written communications in Spanish. The Bureau may also refer consumers to other regulators and resources, as needed.
National Center for Education Statistics, Institute of Education Sciences, Department of Education.
Notice.
The Secretary announces dates for State educational agencies (SEAs) to submit expenditure and revenue data and average daily attendance statistics on ED Form 2447 (the National Public Education Financial Survey (NPEFS)) for fiscal year (FY) 2017, revisions to those reports, and revisions to reports for previous fiscal years. The Secretary sets these dates to ensure that data are available to serve as the basis for timely distribution of Federal funds. The U.S. Census Bureau is the data collection agent for this request of the Department of Education's National Center for Education Statistics (NCES). The data will be published by NCES and will be used by the Secretary in the calculation of allocations for FY 2019 appropriated funds.
SEAs can begin submitting data on Wednesday, January 31, 2018. SEAs are urged to submit accurate and complete data by Friday, March 30, 2018, to facilitate timely processing. The deadline for the final submission of all data, including any revisions to previously submitted data for FY 2016 and FY 2017, is Wednesday, August 15, 2018. Any resubmissions of FY 2016 or FY 2017 data by SEAs in response to requests for clarification or reconciliation or other inquiries by NCES or the Census Bureau must be completed as soon as possible, but no later than Tuesday, September 4, 2018. All outstanding data issues must be reconciled or resolved by the SEAs, NCES, and the Census Bureau as soon as possible, but no later than September 4, 2018.
If an SEA's submission is received by the Census Bureau after August 15, 2018, the SEA must show one of the following as proof that the submission was mailed on or before that date:
1. A legibly dated U.S. Postal Service postmark.
2. A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.
3. A dated shipping label, invoice, or receipt from a commercial carrier.
4. Any other proof of mailing acceptable to the Secretary.
If the SEA mails ED Form 2447 through the U.S. Postal Service, the Secretary does not accept either of the following as proof of mailing:
1. A private metered postmark.
2. A mail receipt that is not dated by the U.S. Postal Service.
The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, an SEA should check with its local post office.
SEAs may submit data online using the interactive survey form on the NPEFS data collection Web site at:
Alternatively, SEAs may hand-deliver submissions by 4:00 p.m. Washington, DC time on August 15, 2018, to: U.S. Census Bureau, Economic Reimbursable Surveys Division, 4600 Silver Hill Road, Suitland, MD 20746.
Mr. Stephen Q. Cornman, NPEFS Project Director, National Center for Education
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service, toll free, at 1-800-877-8339.
Under section 153(a)(1)(I) of the Education Sciences Reform Act of 2002, 20 U.S.C. 9543(a)(1)(I), which authorizes NCES to gather data on the financing and management of education, NCES collects data annually from SEAs through ED Form 2447. The report from SEAs includes attendance, revenue, and expenditure data from which NCES determines a State's “average per-pupil expenditure” (SPPE) for elementary and secondary education, as defined in section 8101(2) of the Elementary and Secondary Education Act of 1965, as amended (ESEA) (20 U.S.C. 7801(2)).
In addition to using the SPPE data as general information on the financing of elementary and secondary education, the Secretary uses these data directly in calculating allocations for certain formula grant programs, including, but not limited to, title I, part A of the ESEA, Impact Aid, and Indian Education programs. Other programs, such as the Education for Homeless Children and Youth program under title VII of the McKinney-Vento Homeless Assistance Act and the Teacher Quality State Grants program (title II, part A of the ESEA), make use of SPPE data indirectly because their formulas are based, in whole or in part, on State title I, part A allocations.
In January 2018, the Census Bureau, acting as the data collection agent for NCES, will email ED Form 2447 to SEAs, with instructions, and will request that SEAs commence submitting FY 2017 data to the Census Bureau on Wednesday, January 31, 2018. SEAs are urged to submit accurate and complete data by Friday, March 30, 2018, to facilitate timely processing.
Submissions by SEAs to the Census Bureau will be analyzed for accuracy and returned to each SEA for verification. SEAs must submit all data, including any revisions to FY 2016 and FY 2017 data, to the Census Bureau no later than Wednesday, August 15, 2018. Any resubmissions of FY 2016 or FY 2017 data by SEAs in response to requests for clarification or reconciliation or other inquiries by NCES or the Census Bureau must be completed by Tuesday, September 4, 2018. Between August 15, 2018, and September 4, 2018, SEAs may also, on their own initiative, resubmit data to resolve issues not addressed in their final submission of NPEFS data by August 15, 2018. All outstanding data issues must be reconciled or resolved by the SEAs, NCES, and the Census Bureau as soon as possible, but no later than September 4, 2018.
In order to facilitate timely submission of data, the Census Bureau will send reminder notices to SEAs in June and July of 2018.
Having accurate, consistent, and timely information is critical to an efficient and fair Department of Education (Department) allocation process and to the NCES statistical process. To ensure timely distribution of Federal education funds based on the best, most accurate data available, the Department establishes, for program funding allocation purposes, Wednesday, August 15, 2018, as the final date by which the SEAs must submit data using either the interactive survey form on the NPEFS data collection Web site at:
Any resubmissions of FY 2016 or FY 2017 data by SEAs in response to requests for clarification or reconciliation or other inquiries by NCES or the Census Bureau must be completed through the interactive survey form on the NPEFS data collection Web site or ED Form 2447 by Tuesday, September 4, 2018. If an SEA submits revised data after the final deadline that result in a lower SPPE figure, the SEA's allocations may be adjusted downward, or the Department may direct the SEA to return funds. SEAs should be aware that all of these data are subject to audit and that, if any inaccuracies are discovered in the audit process, the Department may seek recovery of overpayments for the applicable programs.
The following are important dates in the data collection process for FY 2017 data and revisions to reports for previous fiscal years:
January 31, 2018—SEAs can begin to submit accurate and complete data for FY 2017 and revisions to previously submitted data for FY 2016.
March 30, 2018—Date by which SEAs are urged to submit accurate and complete data for FY 2016 and FY 2017.
August 15, 2018—Mandatory final submission date for FY 2016 and FY 2017 data to be used for program funding allocation purposes.
September 4, 2018—Mandatory final deadline for responses by SEAs to requests for clarification or reconciliation or other inquiries by NCES or the Census Bureau. All data issues must be resolved.
At this site you can view this document, as well as all other documents of this Department published in the
You may also access documents of the Department published in the
Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.
20 U.S.C. 9543.
Take notice that on November 8, 2017, pursuant to section 292.205(c) of the Federal Energy Regulatory Commission's (Commission) implementing the Public Utility Regulatory Policies Act of 1978, as amended 18 CFR 292.205(c) (2017), Elk Hills Power, LLC (EHP) submitted a request for limited waiver of the operating standard set forth in section 292.205(a)(1) for the topping-cycle cogeneration facility owned and
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the eFiling link at
This filing is accessible on-line at
Federal Energy Regulatory Commission, Department of Energy.
Notice of revised information collection and request for comments.
In compliance with the requirements of the Paperwork Reduction Act of 1995, the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on revisions to the information collection, FERC-725HH (RF Reliability Standards) which will be submitted to the Office of Management and Budget (OMB) for review of the information collection requirements.
Comments on the collection of information are due January 16, 2018.
You may submit comments identified by Docket Nos. RD17-8-000 by either of the following methods:
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Ellen Brown may be reached by email at
RF promotes bulk electric system reliability in the Eastern Interconnection. RF is the Regional Entity responsible for compliance monitoring and enforcement in the RF region. In addition, RF provides an environment for the development of Reliability Standards and the coordination of the operating and planning activities of its members as set forth in the RF bylaws.
There is one regional Reliability Standard in the RF region. The regional Reliability Standard requires planning coordinators within the RF geographical footprint to analyze, assess and document resource adequacy for load in the RF footprint annually, to utilize a “one day in ten years” loss of load criterion, and to document and post load and resource capability in each area or transmission-constrained sub-area identified.
• BAL-502-RFC-02 (Planning Resource Adequacy Analysis, Assessment and Documentation)
The Commission's request to OMB reflects the following:
• Implementing the regional Reliability Standard BAL-502-RF-03 and the retirement of regional Reliability Standard BAL-502-RFC-02
On September 7, 2017, NERC and RF filed a joint petition in Docket No. RD17-8-000
• Manager (Occupation Code 11-0000): $81.52/hour.
• Engineer (Occupation Code 17-2071): $68.12/hour.
• File Clerk (Occupation Code 43-4071): $32.74/hour.
The hourly cost for the reporting requirements ($60.79) is an average of the cost of a manager, an engineer, and a file clerk.
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
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j. The current license for the Lower Mousam Project was issued to Kennebunk Light and Power District (Kennebunk Light) under Project No. 5362. On March 29, 2017, Kennebunk Light filed a notice stating that it does not intend to file an application for a subsequent license. In response to a solicitation issued by the Commission on May 15, 2017, America First Hydro filed a notice of intent to file an application for a license for the Lower Mousam Project and a Pre-Application Document (PAD), pursuant to 18 CFR 5.5 and 5.6 of the Commission's regulations. The licensing proceeding is commencing under Project No. 14856.
k. America First Hydro filed a request to use the Traditional Licensing Process (TLP) on September 11, 2017, which the Commission denied on October 31, 2017. America First Hydro must use the Integrated Licensing Process to prepare a license application for the Lower Mousam Project.
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n. A copy of the PAD is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site (
Register online at
o. With this notice, we are soliciting comments on the PAD and Commission
The Commission strongly encourages electronic filing. Please file all documents using the Commission's eFiling system at
All filings with the Commission must bear the appropriate heading: “Comments on Pre-Application Document,” “Study Requests,” “Comments on Scoping Document 1,” “Request for Cooperating Agency Status,” or “Communications to and from Commission Staff.” Any individual or entity interested in submitting study requests, commenting on the PAD or SD1, and any agency requesting cooperating status must do so within 60 days of the issuance date of this notice.
p. At this time, the Commission intends to prepare an environmental assessment (EA).
Commission staff will hold two scoping meetings in the vicinity of the project at the time and place noted below. The daytime meeting will focus on resource agency, Indian tribes, and non-governmental organization concerns, while the evening meeting is primarily for receiving input from the public. We invite all interested individuals, organizations, and agencies to attend one or both of the meetings, and to assist staff in identifying particular study needs, as well as the scope of environmental issues to be addressed in the environmental document. The times and locations of these meetings are as follows:
Scoping Document 1 (SD1), which outlines the subject areas to be addressed in the environmental document, was mailed to the individuals and entities on the Commission's mailing list. Copies of SD1 will be available at the scoping meetings, or may be viewed on the web at
The potential applicant, the existing licensee, and Commission staff will conduct an Environmental Site Review of the project on Tuesday, December 12, 2017, starting at 9:00 a.m. All participants should meet in the parking lot, located next to the Kesslen Dam on Berry Court Road, Kennebunk, ME 04043. All participants are responsible for their own transportation. Anyone with questions about the site visit should contact Mr. Todd Shea of Kennebunk Light and Power District at (207) 985-3311 on or before December 12, 2017.
At the scoping meetings, staff will: (1) Initiate scoping of the issues; (2) review and discuss existing conditions and resource management objectives; (3) review and discuss existing information and identify preliminary information and study needs; (4) review and discuss the process plan and schedule for pre-filing activity that incorporates the time frames provided for in Part 5 of the Commission's regulations and, to the extent possible, maximizes coordination of federal, state, and tribal permitting and certification processes; and (5) discuss the appropriateness of any federal or state agency or Indian tribe acting as a cooperating agency for development of an environmental document.
Meeting participants should come prepared to discuss their issues and/or concerns. Please review the PAD in preparation for the scoping meetings. Directions on how to obtain a copy of the PAD and SD1 are included in item n of this document.
The meetings will be recorded by a stenographer and will be placed in the public records of the project.
Take notice that on October 27, 2017, East Cheyenne Gas Storage, LLC (East Cheyenne), 10370 Richmond Avenue, Suite 510, Houston, Texas 77042, filed in the above referenced docket an application pursuant to section 7(c) of the Natural Gas Act (NGA), and Part 157 of the Commission's regulations requesting authorization to amend its certificate of public convenience and necessity issued by the Commission in Docket No. CP10-34-000, as amended in Docket Nos. CP11-40-000, CP12-35-000, CP12-124-000, CP14-486-000, and CP16-25-000, to: (i) Consolidate the working gas capacity and cushion gas capacity of the West Peetz and Lewis Creek portions of the East Cheyenne Gas Storage Project (Project) into one working gas capacity and one cushion gas capacity, (ii) allow a unified maximum bottom-hole pressure for the Project reservoir, (iii) reallocate the storage gas capacity in the Project by increasing the working gas capacity and decreasing the cushion gas capacity of the Project by 3.6 billion cubic feet (Bcf) each, (iv) reconfigure certain facilities in the Lewis Creek portion of the Project, and (v) expand the buffer zone of the Project. Also, East Cheyenne requests the Commission to issue an order reaffirming its market-based rate authorization in light of the increase in working gas capacity of the Project, all as more fully set forth in the application which is on file with the Commission and open to public inspection. The
Any questions concerning this application may be directed to James Hoff, Vice President, Reservoir Engineering, East Cheyenne Gas Storage, LLC, 10370 Richmond Avenue, Suite 510, Houston, Texas 77042, at (713) 403-6467.
Pursuant to section 157.9 of the Commission's rules (18 CFR 157.9), within 90 days of this Notice, the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.
There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit seven copies of filings made in the proceeding with the Commission and must mail a copy to the applicant and to every other party. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.
However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.
Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commentors will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commentors will not be required to serve copies of filed documents on all other parties. However, the non-party commentors will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.
The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link 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 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:
This is a supplemental notice in the above-referenced proceeding Southern Partners, INC'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 28, 2017.
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 on October 30, 2017, City of Vernon, California submitted its tariff filing: 2018 Transmission Revenue Requirement and Transmission Revenue Balancing Account Adjustment, to be effective 1/1/2018.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant and all the parties in this proceeding.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the eFiling link at
This filing is accessible on-line at
Take notice that on October 31, 2017, Natural Gas Pipeline Company of America LLC (Natural), 3250 Lacey Road, Downers Grove, Illinois 60515-7918, filed in Docket No. CP18-12-000 an application pursuant to section 7(b) of the Natural Gas Act (NGA), and Part 157 of the Commission's regulations requesting authority to abandon Natural's Herscher Northwest Storage Field (HNW Storage Field) located in Kankakee County, Illinois. Natural states that its HNW Storage Field is an aquifer type gas storage field that has been under-performing and is no longer needed by Natural to provide storage services for its customers or to operate its system.
Specifically, Natural proposes to: (i) Plug and permanently abandon 19 injection and withdrawal (I/W) wells (and to retain one I/W well as an observation (OBS) well; (ii) abandon in place 16.15 miles of 4-inch-diameter to 16-inch-diameter field laterals, (iii) abandon by removal Compressor Station 202, a 330 horsepower compressor station, located in the HNW Storage Field; and (iv) abandon in place approximately 15.3 Bcf of non-recoverable cushion gas. Additionally, Natural plans to plug and permanently abandon 13 OBS wells (one would be retained for continued observation purposes) and a salt water disposal well. Natural would also remove all auxiliary surface facilities, all as more fully set forth in the application which is on file with the Commission and open to public inspection. The filing may also be viewed on the web at
Any questions regarding this application should be directed to Bruce H. Newsome, Vice President, Natural Gas Pipeline Company of America LLC, 3250 Lacey Road, Suite 700, Downers Grove, Illinois 60515-7918; by telephone (630) 725-3070; or by email at
Pursuant to section 157.9 of the Commission's rules (18 CFR 157.9), within 90 days of this Notice, the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's EA.
There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below, file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit five copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.
However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.
Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commentors will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commentors will not be required to serve copies of filed documents on all other parties. However, the non-party commentors will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.
The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at
Take notice that on November 7, 2017, pursuant to section 292.205(c) of the Federal Energy Regulatory Commission's (Commission) implementing the Public Utility Regulatory Policies Act of 1978, as amended 18 CFR 292.205(c) (2017), EF Oxnard LLC (EF Oxnard) submitted a request for limited waiver of the efficiency standard set forth in section 292.205(a)(2) for the topping-cycle cogeneration facility owned and operated by EF Oxnard, as more fully explained in its request.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line 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 clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and § 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
Description: Tariff Amendment: Red Dirt Wind Project, LLC MBR Tariff to be effective 10/15/2017.
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 on November 9, 2017, pursuant to Rule 207 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure,
Any person desiring to intervene or to protest in this proceeding must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Petitioner.
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 proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
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The Commission strongly encourages electronic filing. Please file comments, motions to intervene, and protests using the Commission's eFiling system at
The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
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m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
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Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and § 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Federal Election Commission.
Notice of filing dates for special election.
Pennsylvania has scheduled a special general election on March 13, 2018, to fill the U.S. House of Representatives seat in the 18th Congressional District vacated by Representative Tim Murphy.
Committees required to file reports in connection with the Special General Election on March 13, 2018, shall file a 12-day Pre-General Report, and a 30-day Post-General Report.
Ms. Elizabeth S. Kurland, Information Division, 999 E Street NW., Washington, DC 20463; Telephone: (202) 694-1100; Toll Free (800) 424-9530.
All principal campaign committees of candidates who participate in the Pennsylvania Special General Election shall file a 12-day Pre-General Report on March 1, 2018; and a Post-General Report on April 12, 2018. (See chart below for the closing date for each report.)
Note that these reports are in addition to the campaign committee's regular quarterly filings. (See chart below for the closing date for each report).
Political committees filing on a quarterly basis in 2018 are subject to special election reporting if they make previously undisclosed contributions or expenditures in connection with the Pennsylvania Special General Election by the close of books for the applicable report(s). (See chart below for the closing date for each report.)
Committees filing monthly that make contributions or expenditures in connection with the Pennsylvania Special General Election will continue to file according to the monthly reporting schedule.
Additional disclosure information in connection with the Pennsylvania Special General Election may be found on the FEC Web site at
Principal campaign committees, party committees and Leadership PACs that are otherwise required to file reports in connection with the special elections must simultaneously file FEC Form 3L if they receive two or more bundled contributions from lobbyists/registrants or lobbyist/registrant PACs that aggregate in excess of the lobbyist bundling disclosure threshold during the special election reporting periods (See chart below for closing date of each period.) 11 CFR 104.22(a)(5)(v), (b).
The lobbyist bundling disclosure threshold for calendar year 2017 is $17,900. This threshold amount may increase in 2018 based upon the annual cost of living adjustment (COLA). Once the adjusted threshold amount becomes available, the Commission will publish it in the
On behalf of the Commission,
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 15, 2017.
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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 29, 2017.
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Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice of meeting.
In accordance with the Federal Advisory Committee Act, the CDC, announces the following meeting for BSC, NCHS. This meeting is open to the public; however, visitors must be processed in accordance with established federal policies and procedures. For foreign nationals or non-U.S. citizens, pre-approval is required (please contact Gwen Mustaf, 301-458-4500,
The meeting will be held on January 11, 2018, 11:00 a.m.-5:30 p.m., EDT, and January 12, 2018, 8:30 a.m.-1:00 p.m., EDT.
NCHS Headquarters, 3311 Toledo Road, Hyattsville, Maryland 20782.
Charles J. Rothwell, Director, NCHS/CDC, 3311 Toledo Road, Room 2627, Hyattsville, Maryland 20782, telephone (301) 458-4500, email
Requests to make oral presentations should be submitted in writing to the contact person listed below. All requests must contain the name, address, telephone number, and organizational affiliation of the presenter. Written comments should not exceed five single-spaced typed pages in length and must be received by December 26, 2017. Agenda items are subject to change as priorities dictate.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on “Strengthening United States Response to Resistant Gonorrhea (SURRG).” The goal of the study is to strengthen the U.S response to resistant gonorrhea by enhancing state and local public health surveillance and program infrastructure, build capacity to support rapid detection and public health response to antibiotic-resistant gonorrhea, and advance the understanding of epidemiological factors contributing to antibiotic-resistant gonorrhea.
Written comments must be received on or before January 16, 2018.
You may submit comments, identified by Docket No. CDC-2017-0081 by any of the following methods:
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To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
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. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
The OMB is particularly interested in comments that will help:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
5. Assess information collection costs.
Strengthening U.S. Response to Resistant Gonorrhea (SURRG)—New—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
The purposes of
SURRG will support rapid detection of resistant gonorrhea and get actionable information into the hands of healthcare providers (to support appropriate treatment of individual patients) and local health departments (to support rapid public health response to slow the spread of resistant infections).
Jurisdictions participating in SURRG applied as part of a competitive process and will participate voluntarily. As an overview of SURRG, healthcare providers at participating clinics (sexually transmitted disease [STD] clinics affiliated with a single public health department or other participating non-STD clinic sites) will collect specimens for
Researchers will interview the patient (from whom the resistant specimen was collected) about risk factors and recent contacts, and will re-test to ensure cure. The health department will interview recent contacts and test them for gonorrhea. The participating health departments will collect and transmit to CDC, demographic and clinical data about persons tested for and diagnosed with gonorrhea in the participating clinics, results of local antibiotic resistance testing, and information about field investigations.
None of the data transmitted to CDC will contain any personally identifiable information. CDC will use the data to monitor resistance, understand risk factors for resistance, and identify new approaches to prevent the spread of resistance. CDC will receive transmitted data through its Secure Access Management Services (SAMS).
SAMS is an approved federal information technology system that provides authorized and validated users secure and encrypted access to CDC file transfer applications. The encrypted data will be stored in a secure CDC server with strictly controlled and restricted access rights.
Researchers will ship isolates each month to one of four Antibiotic Resistance Regional Laboratory Network (ARLN) laboratories for confirmatory antibiotic susceptibility testing and molecular characterization.
Under the SURRG protocol, the local SURRG data managers from each of the funded jurisdictions will abstract STD clinic data for patients tested for gonorrhea, receive data from non-STD clinic healthcare sites about persons tested for gonorrhea, receive resistance testing laboratory results from local public health laboratories, abstract data about field investigations, and will merge the data. Every two months, the local SURRG data manager will clean the data, remove personally identifiable information, and transmit the data to CDC. We estimate these data processes will take 16 hours every two months. Annually, the local SURRG data manager will send a final cumulative data file. Seven data transmissions/responses will occur.
Every two months, data managers at each of the participating non-STD clinic health centers will abstract and clean data and securely transmit the data to the local SURRG data manager. We estimate that it will take three hours each time data managers at each non-STD SURRG location abstract, clean, and transmit SURRG data.
Microbiologists at public health laboratories from each of the nine SURRG funded jurisdictions will conduct antibiotic resistance testing on all
Health department staff will interview any person diagnosed with antibiotic-resistant gonorrhea or have a case of gonorrhea of public health significance index case, a diagnosed person's social and sexual contacts, and the sexual contacts of the index case's sexual contacts.
On average, each jurisdiction will identify four drug-resistant isolates each month. These isolates will spur field investigations, which will result in six additional interviews each month. We estimate 120 interviews will occur annually at each site (annual 1,080 interviews for the 9 sites). Each interview will take 30 minutes.
The total estimated annual burden hours are 2,976. Respondents receive federal funds to participate in this project. There are no additional costs to respondents other than their time.
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 18, 2017.
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 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.
William Parham at (410) 786-4669.
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
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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 18, 2017.
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 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.
William Parham at (410) 786-4669.
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
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In compliance with the requirements of the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chap 35), the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington, DC 20201. Attn: ACF Reports Clearance Officer. Email address:
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.” This draft guidance concerns FDA's implementation of the Biosimilar User Fee Amendments of 2017 (BsUFA II) and certain intended changes in policies and procedures surrounding its application.
Submit either electronic or written comments on the draft guidance by January 16, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
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• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
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• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Beena Alex, Division of User Fee Management and Budget Formulation, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Rm. 2185, Silver Spring, MD 20993, 301-796-7900,
FDA is announcing the availability of a draft guidance for industry entitled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.” This draft guidance concerns the implementation of BsUFA II, including an explanation about the new fee structure and types of fees for which entities are responsible. BsUFA II extends FDA's authority to collect user fees from fiscal year 2018 to 2022 and introduces a number of technical revisions that affect what fees are collected and how fees are collected. Fees authorized by this legislation help fund the process for the review of biosimilar biological product applications and have played an important role in expediting the review and approval process.
BsUFA II authorizes biosimilar biological product development
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on assessing user fees under BsUFA II. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the collection of information associated with this document, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
This information collection supports “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017: Draft Guidance for Industry.” The Federal Food, Drug, and Cosmetic Act as amended by the Biosimilar User Fee Act of 2012 and recently renewed in 2017 (BsUFA II) under the FDA Reauthorization Act of 2017, authorizes FDA to assess and collect user fees from companies that produce biosimilar biological products in conjunction with the review of biosimilar biological product applications. The draft guidance includes processing and policies for the initial and the annual BPD fees; the BPD discontinuation process requirements and BPD reactivation fees; process and policies for biosimilar biological product application fees including exceptions to the application fees and refund of fees; process and policies for the small business waiver of the biosimilar application fee; and implementation of the biosimilar biological product program fee.
The burdens associated with requesting a small business waiver of BsUFA fees and the associated burdens for new activities as noted in the draft guidance are listed in table 1.
FDA estimates the annual burden of these new collections of information as follows:
This draft guidance also refers to previously approved collections of information found in FDA forms developed to support its user fee program. Specifically, the draft guidance refers to Form FDA 3792, Form FDA 3913, and Form FDA 3971, which have been approved under OMB control numbers 0910-0718, 0910-0805, and 0910-0693, respectively. The draft guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR part 312 are currently approved under OMB control number 0910-0014; the collections of information regarding new drug applications and biologics license applications are approved under OMB control numbers 0910-0001 and 0910-0338, respectively.
Persons with access to the Internet may obtain the draft guidance at either
Food and Drug Administration; HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) is announcing that the Initial Decision of the Administrative Law Judge (ALJ), to refuse approval of the supplemental new drug application (sNDA) for Mepergan Fortis Capsules (MFC) (meperidine HCl, promethazine HCl), is the final decision of the Commissioner by operation of law. In the Initial Decision, the ALJ found that MFC had not been shown to be supported by substantial evidence consisting of adequate and well-controlled studies to be effective for sedation and analgesia in patients with concurrent moderate pain and apprehension, such as postoperative and post-trauma patients with those symptoms; that the drug did not satisfy the combination drug policy; and that it is a “new drug.” The sNDA applicant filed exceptions to the ALJ's Initial Decision. FDA recently requested that the current owner of the sNDA application affirm its desire to pursue the appeal of the ALJ's Initial Decision; however, the applicant did not affirm its desire to pursue the appeal within the specified timeframe. Accordingly, FDA now deems those exceptions as withdrawn. Consequently, the proceeding is in the same procedural position as if no exceptions to the ALJ's Initial Decision had been filed; therefore, the ALJ's Initial Decision has become the final decision of the Commissioner by operation of law.
This final decision is effective November 16, 2017.
For access to the docket, go to
Rachael Vieder Linowes, Office of Scientific Integrity, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 240-402-5931.
In 1962, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) was amended by the Drug Amendments Act of 1962, and these amendments provided that new drugs could no longer be approved unless both safety and efficacy had been established for them. As amended, the FD&C Act also required FDA to evaluate drugs approved as safe between 1938 and 1962 to determine whether such drugs were effective and to withdraw approval for any new drug application (NDA) where there was not substantial evidence of the drug's effectiveness. The person contesting the withdrawal of the approval had the burden of coming forward with evidence of effectiveness for the drug. FDA's review of these pre-1962 drugs is known as the Drug Efficacy Study Implementation (DESI) program.
In a document published in the
Wyeth submitted its request for a hearing and, by a document published in the
On August 23, 2017, FDA sent a letter to West-Ward Pharmaceuticals Corporation (West-Ward), successor to Wyeth, to determine whether West-Ward remained interested in pursuing its appeal of the ALJ's Initial Decision. FDA informed the company that if it did not respond and affirm its desire to pursue its appeal by September 21, 2017, the Office of the Commissioner would conclude that West-Ward no longer wishes to pursue the appeal of the ALJ's Initial Decision and will proceed as if the appeal has been withdrawn. The Office of the Commissioner did not receive a response from West-Ward by the given date; therefore, the Commissioner now deems the exceptions withdrawn.
Given that the exceptions have been deemed withdrawn, this proceeding is now in the same procedural posture as if no exceptions had ever been filed. When parties do not file exceptions to the ALJ's Initial Decision, and the Commissioner does not file a notice of review, the ALJ's Initial Decision becomes the final decision of the Commissioner (see 21 CFR 12.120(e)). FDA will publish a notice in the
Therefore, the ALJ's Initial Decision is the final decision of the Commissioner effective November 16, 2017. Pursuant to the findings in the ALJ's Initial Decision, under section 505(d) of the FD&C Act (21 U.S.C. 355(d)) and under the authority delegated by the Secretary of Health and Human Services, the Commissioner finds that there is a lack of substantial evidence that MFC will have the effect it purports or is represented to have under the conditions of use prescribed,
The full text of the ALJ's Initial Decision may be seen in the Dockets Management Staff and in this docket (see
Food and Drug Administration, HHS.
Notice; establishment of a public docket; request for comments.
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
The meeting will be held on January 10, 2018, from 8 a.m. to 5 p.m.
College Park Marriott Hotel and Conference Center, Chesapeake Ballroom, 3501 University Blvd. East, Hyattsville, MD 20783. The conference center's telephone number is 301-985-7300. Answers to commonly asked questions about FDA Advisory Committee meetings may be accessed at:
FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2017-N-6292. The docket will close on January 9, 2018. Submit either electronic or written comments on this public meeting by January 9, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 9, 2018. The
Comments received on or before December 22, 2017, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Kalyani Bhatt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, Fax: 301-847-8533, email:
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA 02BC;s Web site after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require special accommodations due to a disability, please contact Kalyani Bhatt at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
National Institutes of Health, HHS.
Notice.
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S.
Licensing information and copies of the patent applications listed below may be obtained by emailing the indicated licensing contact at the National Heart, Lung, and Blood, Office of Technology Transfer and Development Office of Technology Transfer, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892-2479; telephone: 301-402-5579. A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications.
This notice is in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. A description of the technology follows.
• Hepatitis B therapy.
• Hepatocellular carcinoma prophylaxis.
• In vitro data available.
• U.S. Provisional Patent Application 62/534,603 filed July 19, 2017.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
National Institutes of Health, HHS.
Notice.
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs,
To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Margaret Beckwith, Office of Cancer Content, Office of Communications and Public Liaison (OCPL), 9609 Medical Center Drive, Rockville, MD 20892 or call non-toll-free number 240-276-6600 or email your request, including your address to:
This proposed information collection was previously published in the
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
There are currently 552 genetics professionals listed in the directory. Approximately 30-60 new professionals are added to the directory each year. The applicants are nurses, physicians, genetic counselors, and other professionals who provide services related to cancer genetics. The information collected on the application form includes name, professional qualifications, practice locations, and the area of specialization. The information is updated annually using a Web-based update mailer that mirrors the application form.
The NCI Cancer Genetics Services Directory is a unique resource for cancer patients and their families who are
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 180.
National Institutes of Health, HHS.
Notice; correction.
The Department of Health and Human Services, National Institutes of Health published a Notice in the
Dr. Jennifer Guimond, Project Clearance Liaison, Office of Science Policy, Reporting, and Program Analysis, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 31 Center Drive, Room 2A18, Bethesda, Maryland 20892 or call non-toll-free number (301) 496-1877 or Email
On November 9, 2017, the Department of Health and Human Services, National Institutes of Health published a Notice in the
National Institutes of Health, HHS.
Notice; correction.
The Department of Health and Human Services, National Institutes of Health published a Notice in the
Dr. Jennifer Guimond, Project Clearance Liaison, Office of Science Policy, Reporting, and Program Analysis, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 31 Center Drive, Room 2A18, Bethesda, Maryland 20892 or call non-toll-free number (301) 496-1877 or Email
On November 9, 2017, the Department of Health and Human Services, National Institutes of Health published a Notice in the
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Division of Intramural Research Board of Scientific Counselors, NIAID. 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 National Institute of Allergy and Infectious Diseases, 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.
Centers for Disease Control and Prevention, National Institutes of Health.
Notice.
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, on behalf of the Centers for Disease Control and Prevention, Department of Health and Human Services, is contemplating the grant of an exclusive patent commercialization license to Becton, Dickinson and Company, located in Franklin Lakes, New Jersey, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.
Only written comments and/or applications for a license which are received by the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases on or before December 1, 2017 will be considered.
Requests for copies of the patent applications, inquiries, and comments relating to the contemplated exclusive patent commercialization license should be directed to: Karen Surabian, Licensing and Patenting Manager, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Suite 2G, MSC9804, Rockville, MD 20852-9804, phone number 301-594-9719, or
The following represents the intellectual property to be licensed under the prospective agreement: HHS Reference No. E-162-2013/0-US-01, United States Provisional Patent Application Serial Number 61/672,059, filed 07/16/2012; HHS Reference No. E-162-2013/0-PCT-02, PCT Patent Application
The prospective exclusive patent commercialization license territory may be worldwide and the field of use may be limited to: “Use of the licensed patent rights for the development, manufacture, and sale of a lateral flow device for detection of antineoplastic drugs from surfaces”.
Many types of cancers are treated with antineoplastic drugs, also known as anti-cancer drugs or chemotherapy. Exposure of healthcare workers to these hazardous drugs from contaminated surfaces may cause acute and long-term effects. Approximately eight (8) million United States healthcare workers are potentially exposed to these hazardous drugs. Although there are potential therapeutic benefits of hazardous drugs that outweigh the risks of side effects for ill patients, healthcare workers are exposed to the risk with the same side effects with no therapeutic benefit. Occupational exposures to hazardous drugs can lead to skin rashes and major reproductive effects, which include increased fetal loss, congenital malformations, low birth weight, congenital abnormalities, and infertility. The risk of cancer is also increased after exposure to these drugs.
This invention, developed within the National Institute for Occupational Safety and Health at the Centers for Disease Control and Prevention, describes a lateral flow assay-based antineoplastic drug detection method that utilizes antibodies specific for individual drugs. It uses detectors for the assessment of drug residues on surfaces, which can be incorporated into small, portable drug detection devices that allow healthcare workers to sample surfaces in near real time, avoiding the need to take samples back to the laboratory to be tested.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive patent commercialization license will be royalty bearing and may be granted unless within fifteen (15) days from the date of this published notice, the National Institute of Allergy and Infectious Diseases receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.
Complete applications for a license in the prospective field of use that are timely filed in response to this notice will be treated as objections to the grant of the contemplated exclusive patent commercialization license. Comments and objections submitted in response to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Board of Scientific Counselors, National Eye Institute.
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 grant applications conducted by the NATIONAL EYE INSTITUTE, 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.
Information is also available on the Institute's/Center's home page:
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of California (FEMA-4344-DR), dated October 10, 2017, and related determinations.
This amendment was issued November 7, 2017.
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 disaster is closed effective October 31, 2017.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster for the Commonwealth of Puerto Rico (FEMA-4339-DR), dated September 20, 2017, and related determinations.
This amendment was issued November 2, 2017.
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 November 2, 2017, the President amended the cost-sharing arrangements regarding Federal funds provided under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
I have determined that the damage in certain areas of the Commonwealth of Puerto Rico resulting from Hurricane Maria beginning on September 17, 2017, and continuing, is of sufficient severity and magnitude that special cost-sharing arrangements are warranted regarding Federal funds provided under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
Due to the extraordinary level of impact to the Commonwealth's infrastructure caused by Hurricane Maria as well as a debt burden of more than $120 billion subject to court-supervised debt restructuring, and recognizing the Commonwealth's election on October 30, 2017, to participate in alternative procedures for all large project funding for Public Assistance Categories C-G pursuant to section 428 of the Stafford Act, I amend my declarations of September 20, 2017 and September 26, 2017, to authorize Federal funds for all categories of Public Assistance at 90 percent of total eligible costs, except for assistance previously approved at 100 percent, subject to the following grant conditions, which I direct you to reflect in the agreement between the Commonwealth and the Federal Emergency Management Agency (FEMA):
1. The Commonwealth establish a Commonwealth grant oversight authority, supported by third-party experts, to perform as the grant recipient for Public Assistance and Hazard Mitigation funding to ensure sound project management and enhanced, centralized control and oversight over the distribution of FEMA grant funds;
2. All large project funding for Public Assistance Categories C-G be obligated by FEMA only through alternative procedures as FEMA shall establish under section 428 of the Stafford Act, including third-party independent expert validation of estimates for projects exceeding a threshold FEMA shall establish consistent with law; and
3. Hazard Mitigation grant funding available under section 404 of the Stafford Act be prioritized toward protecting Federal investments in Puerto Rico's public infrastructure.
This adjustment to Commonwealth and local cost sharing applies only to Public Assistance costs and direct Federal assistance eligible for such adjustments under the law. The Stafford Act specifically prohibits a similar adjustment for funds provided for Other Needs Assistance (section 408) and the Hazard Mitigation Grant Program (section 404). These funds will continue to be reimbursed at 75 percent of total eligible costs.
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-4346-DR), dated October 16, 2017, and related determinations.
This amendment was issued November 1, 2017.
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 16, 2017.
Abbeville, Newberry, and Saluda Counties for Public Assistance.
Aiken, Calhoun, Cherokee, Chester, Chesterfield, Clarendon, Darlington, Dillon, Fairfield, Florence, Greenville, Greenwood, Horry, Kershaw, Lancaster, Laurens, Lee, Lexington, Marion, Marlboro, Orangeburg, Richland, Spartanburg, Sumter, Union, Williamsburg, and York Counties and the Catawba Indian Nation for emergency protective measures [Category B] under the Public Assistance program.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the Commonwealth of Puerto Rico (FEMA-4339-DR), dated September 20, 2017, and related determinations.
This amendment was issued November 2, 2017.
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 Commonwealth of Puerto Rico is hereby amended to include permanent work under the Public Assistance program for those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of September 20, 2017.
All municipalities in the Commonwealth of Puerto Rico 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).
U.S. Immigration and Customs Enforcement, Department of Homeland Security.
30-Day notice.
The Department of Homeland Security (DHS), U.S. Immigration and Customs Enforcement (USICE) is submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the
Written comments and/or suggestions regarding the items contained in this notice, especially regarding the estimated public burden and associated response time, must be directed to the OMB Desk Officer for U.S. Immigration and Customs Enforcement, Department of Homeland Security and sent via electronic mail to
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
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(2)
(3)
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(5)
(6)
U.S. Citizenship and Immigration Services, Department of Homeland Security.
60-Day notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension. In accordance with the Paperwork Reduction Act (PRA) of 1995, the
Comments are encouraged and will be accepted for 60 days until January 16, 2018.
All submissions received must include the OMB Control Number 1615-0034 in the body of the letter, the agency name and Docket ID USCIS-2007-0014. To avoid duplicate submissions, please use only
(1)
(2)
USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, 20 Massachusetts Avenue NW., Washington, DC 20529-2140, telephone number 202-272-8377 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS Web site at
You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at:
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
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Bureau of Indian Affairs, Interior.
Notice of Information Collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, the Bureau of Indian Affairs (BIA) is proposing to renew an information collection.
Interested persons are invited to submit comments on or before January 16, 2018.
Send your comments on the information collection request (ICR) by mail to Ms. Charlene Toledo, Bureau of Indian Affairs, Office of Trust Services, Division of Probate Services 2600 N Central Ave., STE MS 102, Phoenix, AZ 85004: or email to
To request additional information about this ICR, contact Ms. Charlene Toledo by telephone at (505) 563-3371.
In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information
We are soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the BIA (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the BIA enhance the quality, utility, and clarity of the information to be collected; and (5) how might the BIA minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
National Park Service, Interior.
Notice.
The National Park Service (NPS), U.S. Department of the Interior (Department), is seeking nominations for individuals to be considered for appointment to the National Park System Advisory Board (Board). The Board advises the Secretary of the Interior (Secretary) and the Director of the National Park Service (Director) on matters relating to the National Park Service (NPS), the National Park System, and programs administered by the NPS. The Board is a discretionary committee established by authority of the Secretary under 54 U.S.C. 100906 and regulated by the Federal Advisory Committee Act (FACA).
Nominations must be postmarked by December 18, 2017.
Nominations should be sent to Shirley Sears, Office of Policy, National Park Service, 1849 C Street NW., Mail Stop 2659, Washington, DC 20240.
Shirley Sears, Office of Policy, National Park Service, 1849 C Street NW., Mail Stop 2659, Washington, DC 20240; by telephone at 202-354-3955; or by email
The purpose of the Board is to provide advice to the Secretary and the Director on matters relating to the NPS, the National Park System, and programs administered by the NPS, including programs administered pursuant to 54 U.S.C. 320101; designation of National Historic Landmarks and National Natural Landmarks; and the national historic significance of proposed National Historic Trails pursuant to the National Trails System Act (16 U.S.C. 1244(b)(3)). The Board may also advise on matters submitted by the Director. The Board is comprised of no more than 12 members who are citizens of the United States and have a demonstrated commitment to the mission of the NPS.
We currently are seeking to appoint 3 members to the Board and are requesting nominations in the fields of anthropology, archaeology, historical architecture, landscape architecture, biology, ecology, geology, history, and social science; and for a locally elected official adjacent to a park.
Nominations should be typed, and must include a resume providing an adequate description of the nominee's qualifications, including information that would enable the Department to make an informed decision regarding meeting the membership requirements of the Board and permit the Department to contact a potential member.
Members of the Board serve as special Government employees (SGEs), and are required to have ethics training annually and to file a Confidential Financial Disclosure Report. Members serve without compensation. However, while away from their homes or regular places of business in the performance of services for the Board as approved by the Designated Federal Officer, members are allowed travel expenses, including per diem in lieu of subsistence, in the same manner as persons employed intermittently in Government service are allowed such expenses under 5 U.S.C. 5703.
Individuals who are federally registered lobbyists are ineligible to serve on all FACA and non-FACA boards, committees, or councils in an individual capacity. The term “individual capacity” refers to individuals who are appointed to exercise their own individual best judgment on behalf of the Government, such as when they are designated SGEs, rather than being appointed to represent a particular interest.
54 U.S.C. 100906; 5 U.S.C. Appendix 2.
Bureau of Safety and Environmental Enforcement, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Safety and Environmental Enforcement (BSEE) are proposing to renew an information collection with revisions.
Interested persons are invited to submit comments on or before January 16, 2018.
Send your comments on this information collection request (ICR) by either of the following methods listed below:
• Electronically go to
• Email
To request additional information about this ICR, contact Nicole Mason by email at
In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
We are soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of BSEE; (2) Will this information be processed and used in a timely manner; (3) Is the estimate of burden accurate; (4) How might BSEE enhance the quality, utility, and clarity of the information to be collected; and (5) How might BSEE minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
We use the information to ensure that lessees and pipeline ROW holders design the pipelines that they install, maintain, and operate in a safe manner. BSEE needs information concerning the proposed pipeline and safety
We use the information in Form BSEE-0149, Assignment of Federal OCS Pipeline Right-of-Way Grant, to track pipeline ROW holders; as well as use this information to update the corporate database that is used to determine what leases are available for a Lease Sale and the ownership of all OCS leases.
We are adding a new Form BSEE-0135, Designation of Right-of-Way Operator, to identify who has the authority to act on the ROW grant holder's behalf to fulfill obligations under the OCS Lands Act; as well as, BSEE may provide to the designated ROW operator written or oral instructions in securing compliance with the ROW grant in accordance with applicable laws and regulations.
The non-hour cost burdens required in 30 CFR 250, subpart J (and respective cost-recovery fee amount per transaction) are required under:
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Bureau of Safety and Environmental Enforcement, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Safety and Environmental Enforcement (BSEE) are proposing to renew an information collection with revisions.
Interested persons are invited to submit comments on or before January 16, 2018.
Send your comments on this information collection request (ICR) by either of the following methods listed below:
• Electronically go to
• Email
To request additional information about this ICR, contact Nicole Mason by email at
In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
We are soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of BSEE; (2) Will this information be processed and used in a timely manner; (3) Is the estimate of burden accurate; (4) How might BSEE enhance the quality, utility, and clarity of the information to be collected; and (5) How might BSEE minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
• To ensure that operations for the production of minerals other than oil, gas, and sulphur in the OCS are conducted in a manner that will result in orderly resource recovery, development, and the protection of the human, marine, and coastal environments.
• To ensure that adequate measures will be taken during operations to prevent waste, conserve the natural resources of the OCS, and to protect the environment, human life, and correlative rights.
• To determine if suspensions of activities are in the national interest, to facilitate proper development of a lease including reasonable time to develop a mine and construct its supporting facilities, and to allow for the construction or negotiation for use of transportation facilities.
• To identify and evaluate the cause(s) of a hazard(s) generating a suspension, the potential damage from a hazard(s) and the measures available to mitigate the potential for damage.
• For technical evaluations that provide a basis for BSEE to make informed decisions to approve, disapprove, or require modification of the proposed activities.
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (“ID”) (Order No. 9) of the presiding administrative law judge (“ALJ”), granting complainant's motion for leave to amend the complaint in the above-captioned investigation
Cathy Chen, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2392. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server at
The Commission instituted this investigation on September 15, 2017, based on a complaint filed by Broadcom Limited of San Jose, California; and Avago Technologies General IP (Singapore) Pte. Ltd. of Singapore (collectively, “Broadcom”). 82 FR 43404 (Sep. 15, 2017). The complaint, as supplemented, alleges violations of section 337 of the Tariff Act of 1930, as amended, 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 wireless audio systems and components thereof by reason of infringement of claim 20 of U.S. Patent No. 6,684,060. The complaint further alleges that an
On September 20, 2017, Broadcom filed a motion for leave to file a second amended complaint. Broadcom sought to amend the complaint to: (1) Incorporate additional information that was set forth in a pre-institution letter to the Commission on August 29, 2017; (2) correct the names for certain respondents; and (3) add an additional domestic industry claim related to another licensee of the asserted patent. On October 2, 2017, Respondents filed a response opposing only the addition of a new domestic industry claim. The ALJ issued the subject ID granting the motion on October 24, 2017. The ALJ found that Broadcom has shown good cause to amend the complaint under Commission Rule 210.14(b)(1).
No petitions for review were filed. The Commission has determined not to review the ID.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in Part 210 of the Commission's Rules of Practice and Procedure, 19 CFR part 210.
By order of the Commission.
On the basis of the record
Pursuant to section 207.18 of the Commission's rules, the Commission also gives notice of the commencement of the final phase of its investigations. The Commission will issue a final phase notice of scheduling, which will be published in the
On September 28, 2017, The Chemours Company FC LLC, Wilmington, Delaware, filed petitions with the Commission and Commerce, alleging that an industry in the United States is materially injured or threatened with material injury by reason of LTFV and subsidized imports of PTFE resin from India and LTFV imports of PTFE resin from China. Accordingly, effective September 28, 2017, the Commission, pursuant to sections 703(a) and 733(a) of the Act (19 U.S.C. 1671b(a) and 1673b(a)), instituted countervailing duty investigation No. 701-TA-588 and antidumping duty investigation Nos. 731-TA-1392 and 1393 (Preliminary).
Notice of the institution of the Commission's investigations and of a public conference to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the
The Commission made these determinations pursuant to sections 703(a) and 733(a) of the Act (19 U.S.C. 1671b(a) and 1673b(a)). It completed and filed its determinations in these investigations on November 13, 2017. The views of the Commission are contained in USITC Publication 4741 (November 2017), entitled
By order of the Commission.
United States International Trade Commission.
Notice.
In accordance with the provisions of the Paperwork Reduction Act of 1995, the U.S. International Trade Commission (Commission) hereby gives notice that it plans to submit a request for approval of a questionnaire to the Office of Management and Budget (OMB) for review and requests public comment on its draft proposed collection.
To ensure consideration, written comments must be submitted on or before January 15, 2018.
The project leaders for these investigations are Dan Kim and Alissa Tafti (Inv. No. 332-562) and Ricky Ubee and Christopher Robinson (Inv. No. 332-563). Please direct all written comments to the project leaders via email at
(1) Number of forms submitted: 1.
(2) Title of form: Global Digital Trade Questionnaire.
(3) Type of request: New.
(4) Frequency of use: Industry questionnaire, single data gathering, scheduled for 2018.
(5) Description of respondents: U.S. firms in industries involved in global digital trade.
(6) Estimated number of respondents: 13,000.
(7) Estimated total number of hours to complete the questionnaire per respondent: 15 hours.
(8) Information obtained from the questionnaire that qualifies as confidential business information will be so treated by the Commission and not disclosed in a manner that would reveal the individual operations of a firm. Aggregate responses will be considered NSI as requested by USTR.
The U.S. Trade Representative (USTR) has directed the Commission to produce two reports that analyze the regulatory and policy measures in key foreign markets that impact (1) the ability of U.S. firms to develop and/or supply digital products and services abroad, and (2) the competitiveness of U.S. firms as well as international trade and investment flows associated with digital products and services. There will be a single questionnaire used for both investigation 332-562, which will focus on business-to-business digital products and services, and investigation 332-563, which will focus on business-to-consumer digital products and services.
Respondents will be mailed a letter with a link and individual code for accessing the online form. Respondents may also request a fillable form. Once the online form is complete, respondents will be directed to submit the form by selecting a submit button. When respondents complete a fillable form, they may submit it by uploading it to a secure webserver, emailing it to the study team, faxing it, or mailing a hard copy to the Commission.
Comments are invited on (1) whether the proposed collection of information is necessary; (2) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
The draft questionnaire and other supplementary documents may be downloaded from the USITC Web site at
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they will also become a matter of public record.
By order of the Commission.
United States International Trade Commission.
November 21, 2017 at 1:00 p.m.
Room 101, 500 E Street SW., Washington, DC 20436; Telephone: (202) 205-2000.
Open to the public.
1.
2. Minutes.
3. Ratification List.
4. Remedy recommendations in Inv. No. TA-201-76 (Remedy) (Large Residential Washers).
5.
In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
By order of the Commission.
On the basis of the record
Pursuant to section 207.18 of the Commission's rules, the Commission also gives notice of the commencement of the final phase of its investigations. The Commission will issue a final phase notice of scheduling, which will be published in the
On September 26, 2017, DAK Americas LLC, Charlotte, North Carolina; Indorama Ventures USA, Inc., Decatur, Alabama; M&G Polymer USA, LLC, Houston, Texas; and Nan Ya Plastics Corporation, America, Lake City, South Carolina filed petitions with the Commission and Commerce, alleging that an industry in the United States is materially injured and threatened with material injury by reason of LTFV imports of polyethylene terephthalate (PET) resin from Brazil, Indonesia, Korea, Pakistan, and Taiwan. Accordingly, effective September 26, 2017, the Commission, pursuant to section 733(a) of the Act (19 U.S.C. 1673b(a)), instituted antidumping duty investigation Nos. 731-TA-1387-1391 (Preliminary).
Notice of the institution of the Commission's investigations and of a public conference to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the
The Commission made these determinations pursuant to section 733(a) of the Act (19 U.S.C. 1673b(a)). It completed and filed its determinations in these investigations on November 13, 2017. The views of the Commission are contained in USITC Publication 4740 (November 2017), entitled
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 review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the
Comments are encouraged and will be accepted for an additional 30 days until December 18, 2017.
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 Ed Stely, Branch Chief, Tracing Operations and Records Management Branch, National Tracing Center Division, either by mail at 244 Needy Road, Martinsburg, WV 25405, by telephone at 800-788-7133, or by email at
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
(1)
(2)
(3)
(4)
(5)
(6)
(7)
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 review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the
Comments are encouraged and will be accepted for an additional 30 days until December 18, 2017.
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 Desiree M. Dickinson, ATF Firearms and Explosives Imports Branch either by mail at 244 Needy Road, Martinsburg, WV 25405, by or telephone (304) 616-4550, or by email at
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
(1)
(2)
(3)
(4)
(5)
(6)
Notice is hereby given that, on October 26, 2017, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Also, Adept Technology Pvt. Ltd., Chennai, INDIA; ARTEMIS, Hauppauge, NY; Axiomatics AB, Stockholm, SWEDEN; Blue Hawk B&IT Management, Sao Paulo, BRAZIL; Central Bank of the Republic of Turkey, Ankara, TURKEY; Centre for Open Systems, Croydon, AUSTRALIA; CyberCore Technologies, L.L.C., Elkridge, MD; Dansk Unix-system brugergruppe (DKUUG), Copenhagen, DENMARK; General Atomics Aeronautical Systems, Inc., Poway, CA; Inteca sp. z.o.o., Wroclaw, POLAND; ITRI College, Chutung, TAIWAN; Jiangxi University of Finance and Economics, Nanchang, PEOPLE'S REPUBLIC OF CHINA; Open GIS Consortium, Inc., Bloomington, IN; Shanghai Super Information Technology Co. Ltd., Shanghai, PEOPLE'S REPUBLIC OF CHINA; Sites Learning India. Pvt. Ltd., New Delhi, INDIA; and Universidad de Cantabria, Santander, SPAIN, have withdrawn as parties to this venture.
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and TOG intends to file additional written notifications disclosing all changes in membership.
On April 21, 1997, TOG filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on July 24, 2017. A notice was published in the
Notice is hereby given that, on October 13, 2017, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Pursuant to Section 6(b) of the Act, the identities of the parties to the venture are: ATI Specialty Alloys & Components, Pittsburg, PA; Blount International, Inc., Portland, OR; The Boeing Company, Chicago, IL; Daimler Trucks North America LLC, Portland, OR; Hangsterfer's Laboratories, Inc., Mantua, NJ; Oregon Institute of Technology, Klamath Falls, OR; Oregon State University, Corvallis, OR; Portland State University, Portland, OR; Silver Eagle Manufacturing Co., Portland, OR; and Vigor, Portland, OR.
The general area of OMIC R&D's planned activity is bringing together industry, higher education, and government in partnership to develop new tools, techniques, and technologies to address near-term manufacturing challenges through applied research and advanced technical training.
Notice is hereby given that, on October 30, 2017, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and fd.io intends to file additional written notifications disclosing all changes in membership.
On May 4, 2016, fd.io filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on August 24, 2017. A notice was published in the
Notice is hereby given that, on October 24, 2017, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Also, Camco One Industries, LLC, San Antonio, TX; Selective Intellect, LLC, Livingston, NJ; Noble Plastics Inc., Grand Coteau, LA; Meggitt (Orange County), Inc., Irvine, CA; Stevens Institute of Technology, Hoboken, NJ; OMNI Consulting Solutions, LLC, El Segundo, CA; Gun IQ International, LLC, Titusville, FL; Matrix Systems, Inc., Ashland, VA; Reperi LLC, Whitefish, MT; Kongsberg Protech Systems USA Corporation, Johnstown, PA; SCIENTIA, LLC, Bloomington, IN; and Corning Inc., Corning, NY, have withdrawn as parties to this venture.
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and NAC intends to file additional written notifications disclosing all changes in membership.
On May 2, 2000, NAC filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on July 13, 2017. A notice was published in the
Notice is hereby given that, on October 20, 2017, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Also, RF IDeas, Inc., Rolling Meadows, IL; Define Instruments, Auckland, NEW ZEALAND; Celerity, Inc., Hatfield, PA; Sencon, Bedford Park, IL; Northwire Inc., Osceola, WI; and Osaka Vacuum, Ltd., Osaka, JAPAN, have withdrawn as parties to this venture.
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and ODVA intends to file additional written notifications disclosing all changes in membership.
On June 21, 1995, ODVA filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on July 27, 2017. A notice was published in the
Notice is hereby given that, on October 25, 2017, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and AIM Photonics intends to file additional written notifications disclosing all changes in membership.
On June 16, 2016, AIM Photonics filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on June 19, 2017. A notice was published in the
Notice is hereby given that, on October 24, 2017, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Pursuant to Section 6(b) of the Act, the identities of the parties to the venture are: General Motors LLC, Warren, MI; Ford Motor Company, Dearborn, MI; Honda R&D Americas, Inc., Torrance, CA; Hyundai-Kia America Technical Center, Inc., Superior Township, MI; Mercedes-Benz Research & Development North America, Ann Arbor, MI; Nissan Technical Center North America, Farmington Hills, MI; Toyota Motor North America, Plano, TX; and Volvo Group North America, Costa Mesa, CA. The general area of APSCS Consortium's planned activity is collaboration to conduct multiple research projects limited to specific areas in which the participants believe common solutions to specifically defined technical goals will speed the development and ultimate consumer access to safe Automated Driving Systems-equipped (ADS-equipped) vehicles. APSCS Consortium's objectives are to gain further knowledge and understanding of ADS-equipped vehicle interactions with public safety through research into common operational use cases.
Notice is hereby given that, on October 26, 2017, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and Node.js Foundation intends to file additional written notifications disclosing all changes in membership.
On August 17, 2015, Node.js Foundation filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on August 14, 2017. A notice was published in the
Bureau of Justice Statistics, Department of Justice.
60-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.
Comments are encouraged and will be accepted for 60 days until January 16, 2018.
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 Shelley S. Hyland, Statistician, Law Enforcement Statistics Unit, 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:
(1)
(2)
(3)
(4)
The 2018 CSLLEA collection involves two phases. In the first phase, BJS will cognitively test the revised instrument with 48 agencies based on agency type (
Pending positive results from the first phase, in the second phase, BJS will conduct the main data collection. The 2018 CSLLEA is designed to collect general information on state, county and local law enforcement agencies. The survey asks about the level of government that operates the agency; total operating budget; full-time and part-time personnel counts for fully sworn officers, limited sworn officers and non-sworn employees; gender and primary job responsibility of full-time sworn officers; and the functions the agency performs on a regular or primary basis. Upon completion, the 2018 CSLLEA will serve as the sampling frame for future law enforcement surveys administered by BJS.
(5)
(6)
On November 9, 2017, the Department of Justice lodged a proposed Second Amended Consent Decree with the United States District Court for the Western District of Missouri in the lawsuit entitled
The Consent Decree (“CD”) requires, among other measures intended to reduce or eliminate sewage overflows from Kansas City's sewer system, that
The publication of this notice opens a period for public comment on the proposed Second Amended Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to
All comments must be submitted no later than thirty (30) days after the publication date of this notice. Comments may be submitted either by email or by mail:
During the public comment period, Consent Decree may be examined and downloaded at this Justice Department Web site:
Please enclose a check or money order for $9.00 (25 cents per page reproduction cost) payable to the United States Treasury.
Department of Justice.
Notice.
This notice advises the public that the State of Arizona has requested certification of its capital counsel mechanism by the Attorney General and that public comments may be submitted to the Department of Justice regarding Arizona's request.
Written and electronic comments must be submitted on or before January 16, 2018. Comments received by mail will be considered timely if they are postmarked on or before that date. The electronic Federal Docket Management System (FDMS) will accept comments until Midnight Eastern Time at the end of that day.
To ensure proper handling of comments, please reference “Docket No. OLP 166” on all electronic and written correspondence. The Department encourages that all comments be submitted electronically through
Laurence Rothenberg, Deputy Assistant Attorney General, Office of Legal Policy, U.S. Department of Justice, 950 Pennsylvania Avenue NW., Washington, DC 20530; telephone (202) 532-4465.
Chapter 154 of title 28, United States Code, provides special procedures for federal habeas corpus review of cases brought by indigent prisoners in State custody who are subject to capital sentences. These special procedures may be available to a State only if the Attorney General of the United States has certified that the State has established a qualifying mechanism for the appointment, compensation, and payment of reasonable litigation expenses of competent counsel in State postconviction proceedings for indigent capital prisoners. 28 U.S.C. 2261, 2265; 28 CFR part 26.
This notice advises the public, pursuant to 28 CFR 26.23(b), that the State of Arizona has requested certification of its capital counsel mechanism by the Attorney General. Public comment is solicited regarding Arizona's request. Arizona's request and supporting materials may be viewed at
On November 9, 2017, the Department of Justice and the State of California on behalf of the California Department of Toxic Substances Control and Toxic Substances Control Account (“DTSC”) lodged a proposed amendment (“Amendment 1”) to a Consent Decree with the United States District Court for the Central District of California (“Court”) in the matter of
The Consent Decree resolves certain claims under Sections 106 and 107 of the Comprehensive Environmental Response, Compensation, and Liability Act, 42 U.S.C. 9606, 9607, and Section 7003 of the Resource Conservation and Recovery Act, 42 U.S.C. 6973, as well as related state law claims, in connection with environmental contamination at OU2. The Amendment adds the following additional settling parties as Settling Cash Defendants:
(a) Two parties, Mission Linen Supply Company and Pilot Chemical Corp., each of which has owned or operated a facility within the commingled OU2 groundwater plume area. These parties
(b) Two parties, Hexion Inc. and MCP Foods, Inc., who are successors to the liability of a single “arranger” party who sent waste to the Omega Chemical Corporation facility in Whittier, California; and
(c) Twenty-six parties that had previously resolved their liability associated with the Omega Chemical Corporation facility: American International Industries; Atoll Holdings, Inc.; Brunton Enterprises, Inc.; Carvin Corp.; Central Plaza; Corchem Corporation; Couch and Philippi, Inc.; Ed-Lin Auto Body, Inc.; Gamboa's Body and Frame Inc.; Good-West Rubber Corp; I & I Deburring, Inc.; J.D. Property Management, Inc.; Kwikset Corporation; Luppen Holdings, Inc.; M & M Printed Bag, Inc.; Newton Heat Treating Company, Inc; NMB, Inc. [name correction replacing New Hampshire Ball Bearing (NHBB)]; Northwestern, Inc.; Penske Corporation; Pneudraulics, Inc.; Pocino Foods Company; Quaker City Plating & Silversmith, LP; Rooke Corp. (dba Aviation Equipment); Santa Fe Braun, Inc; Tech-Graphic, Inc.; and Unidynamics/Phoenix, Inc.
This amended settlement requires the additional settling parties in categories (a) and (b) to pay $12,625,000 into Qualified Settlement Funds, as provided for in Paragraph 27(a) of the Consent Decree. The parties in category (c) are parties that have previously resolved their liability within the group of generators at the Omega Chemical Corporation facility, and are not required to pay money to the United States and DTSC.
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
As provided by RCRA, a public meeting will be held on the proposed settlement if requested in writing by fifteen (15) days after the publication date of this notice. Requests for a public meeting may be made by contacting the EPA Remedial Project Manager for OU2, Wayne Praskins, by email at
During the public comment period, the lodged proposed Amendment and the previously approved Consent Decree may be examined and downloaded at this Justice Department Web site:
Please enclose a check or money order for $88.25 (25 cents per page reproduction cost) for the Consent Decree and the proposed Amendment, payable to the United States Treasury. For a paper copy of the Consent Decree and the proposed Amendment without the appendices and signature pages, the cost is $23.25. For a paper copy of the Amendment only (without the original Consent Decree), together with its signature pages, the cost is $1.75.
Department of Justice.
Notice.
This notice advises the public that the State of Texas has requested certification of its capital counsel mechanism by the Attorney General and that public comments may be submitted to the Department of Justice regarding Texas's request.
Written and electronic comments must be submitted on or before January 16, 2018. Comments received by mail will be considered timely if they are postmarked on or before that date. The electronic Federal Docket Management System (FDMS) will accept comments until Midnight Eastern Time at the end of that day.
To ensure proper handling of comments, please reference “Docket No. OLP 167” on all electronic and written correspondence. The Department encourages that all comments be submitted electronically through
Laurence Rothenberg, Deputy Assistant Attorney General, Office of Legal Policy, U.S. Department of Justice, 950 Pennsylvania Avenue NW., Washington, DC 20530; telephone (202) 532-4465.
Chapter 154 of title 28, United States Code, provides special procedures for federal habeas corpus review of cases brought by indigent prisoners in State custody who are subject to capital sentences. These special procedures may be available to a State only if the Attorney General of the United States has certified that the State has established a qualifying mechanism for the appointment, compensation, and payment of reasonable litigation expenses of competent counsel in State postconviction proceedings for indigent capital prisoners. 28 U.S.C. 2261, 2265; 28 CFR part 26.
This notice advises the public, pursuant to 28 CFR 26.23(b), that the State of Texas has requested certification of its capital counsel mechanism by the Attorney General. Public comment is solicited regarding Texas's request. Texas's request and supporting materials may be viewed at
National Science Foundation.
Announcement of Membership of the National Science Foundation's Office of Inspector General Senior Executive Service Performance Review Board.
This announcement of the membership of the National Science Foundation's Office of Inspector General Senior Executive Service Performance Review Board is made in compliance with 5 U.S.C. 4314(c)(4).
Comments should be addressed to Division Director, Division of Human Resource Management, National Science Foundation, Room 15239, 2415 Eisenhower Avenue, Alexandria, VA 22314.
Ms. Dianne Campbell Krieger at the above address or (703) 292-5194.
The membership of the National Science Foundation's Office of Inspector General Senior Executive Service Performance Review Board is as follows:
Three members to be selected from the IG community.
In accordance with Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
Welcome/Introductions; BFA/OIRM/OLPA/Budget Updates; Subcommittee on NSF's Strengthened Oversight of Large Facility Cost Surveillance; Shared Services: Best Practices and Case Studies; Meeting with Dr. Ferrini-Mundy; Tour of Alexandria Headquarters.
Update: Committee on Equal Opportunities in Science and Engineering; Strategic Coordination of NSF's Participation and Outreach with External Organizations; Modernizing NSF; Results from 2017 Federal Employees Viewpoint Survey and Maximizing Employee Performance; Committee Business/Wrap Up.
National Science Foundation.
Announcement of Membership of the National Science Foundation's Senior Executive Service Performance Review Board.
This announcement of the membership of the National Science Foundation's Senior Executive Service Performance Review Board is made in compliance with 5 U.S.C. 4314(c)(4).
Comments should be addressed to Division Director, Division of Human Resource Management, National Science Foundation, Room 15239, 2415 Eisenhower Avenue, Alexandria, VA 22314.
Ms. Dianne Campbell Krieger at the above address or (703) 292-5194.
The membership of the National Science Foundation's Senior Executive Service Performance Review Board is as follows:
National Science Foundation.
Notice of permit applications received.
The National Science Foundation (NSF) is required to publish a notice of permit applications received to conduct activities regulated under the Antarctic Conservation Act of 1978. NSF has published regulations under the Antarctic Conservation Act in the Code of Federal Regulations. This is the required notice of permit applications received.
Interested parties are invited to submit written data, comments, or views with respect to this permit application by December 18, 2017. This application may be inspected by interested parties at the Permit Office, address below.
Comments should be addressed to Permit Office, Office of Polar Programs, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, Virginia 22314.
Nature McGinn, ACA Permit Officer, at the above address, 703-292-8030, or
The National Science Foundation, as directed by the Antarctic Conservation Act of 1978 (Pub. L. 95-541, 45 CFR
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on November 9, 2017, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on November 9, 2017, it filed with the Postal Regulatory Commission a
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange filed a proposal to amend the fee schedule applicable to Members
The text of the proposed rule change is available at the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the
A physical port is utilized by a Member or non-Member to connect to the Exchange at the data centers where the Exchange's servers are located. The Exchange currently maintains a presence in two third-party data centers: (i) The primary data center where the Exchange's business is primarily conducted on a daily basis, and (ii) a secondary data center, which is predominantly maintained for business continuity purposes. The Exchange currently assesses the following physical connectivity fees for Members and non-Members on a monthly basis: $2,000 per physical port that connects to the System
The Exchange believes that the proposed rule change is consistent with the objectives of Section 6 of the Act,
The Exchange believes that the proposed rate is equitable and non-discriminatory in that it applies uniformly to all Members. Members and non-Members will continue to choose whether they want more than one physical port and choose the method of connectivity based on their specific needs. All Members that voluntarily select various service options will be charged the same amount for the same services. As is true of all physical connectivity, all Members and non-Members have the option to select any connectivity option, and there is no differentiation with regard to the fees charged for the service.
The Exchange believes that the proposal represents an equitable allocation of reasonable dues, fees, and other charges as its fees for physical connectivity are reasonably constrained by competitive alternatives. If a particular exchange charges excessive fees for connectivity, affected Members and non-Members may opt to terminate their connectivity arrangements with that exchange, and adopt a possible range of alternative strategies, including routing to the applicable exchange through another participant or market center or taking that exchange's data indirectly. Accordingly, if the Exchange charges excessive fees, it would stand to lose not only connectivity revenues but also revenues associated with the execution of orders routed to it, and, to the extent applicable, market data revenues. The Exchange believes that this competitive dynamic imposes powerful restraints on the ability of any exchange to charge unreasonable fees for connectivity.
Furthermore, the proposed rule change is also an equitable allocation of reasonable dues, fees, and other charges as the Exchange believes that the increased fees obtained will enable it to cover its increased infrastructure costs associated with establishing physical ports to connect to the Exchange's Systems. The additional revenue from the increased fee will also enable the Exchange to continue to maintain and improve its market technology and services.
Lastly, the Exchange believes the fees and credits remain competitive with those charged by other venues and therefore continue to be reasonable and equitably allocated to Members. For instance, the proposed fees for a 10 gigabyte circuit of $7,000 per month is less than analogous fees charged by the Nasdaq Stock Market LLC (“Nasdaq”) and NYSE Arca, Inc. (“Arca”), which range from $10,000-$15,000 per month for 10 gigabyte circuits.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. As discussed above, the Exchange believes that fees for connectivity are constrained by the robust competition for order flow among exchanges and non-exchange markets. The Exchange does not believe that the proposed changes represent a significant departure from previous pricing offered by the Exchange or pricing offered by the Exchange's competitors. Additionally, Members may opt to disfavor the Exchange's pricing if they believe that alternatives offer them better value. Further, excessive fees for connectivity would serve to impair an exchange's ability to compete for order flow rather than burdening competition.
The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The Exchange has not received any unsolicited written comments from Members or other interested parties.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) 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 Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange filed a proposal to amend the fee schedule applicable to Members
The text of the proposed rule change is available at the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend its fee schedule to amend Tier 7 under footnote 1, Add/Remove Volume Tiers. The Exchange currently offers eight tiers under footnote 1 that offer reduced fees for displayed orders that yield fee codes B,
The Exchange believes that the proposed rule change is consistent with the objectives of Section 6 of the Act,
In addition, volume-based fees such as that proposed herein have been widely adopted by exchanges and are equitable because they are open to all Members on an equal basis and provide additional benefits or discounts that are reasonably related to: (i) The value to an exchange's market quality; (ii) associated higher levels of market activity, such as higher levels of liquidity provision and/or growth patterns; and (iii) the introduction of higher volumes of orders into the price and volume discovery processes. The Exchange believes that the proposal is a reasonable, fair and equitable, and not an unfairly discriminatory allocation of fees and rebates, because it will provide Members with an additional incentive to add more liquidity on the Exchange to achieve the tier's increased criteria to receive the enhanced rebate.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe that this change represents a significant departure from previous pricing offered by the Exchange or from pricing offered by the Exchange's competitors. The proposal would apply uniformly to all Members, and Members may opt to disfavor the Exchange's pricing if they believe that alternatives offer them better value. Accordingly, the Exchange does not believe that the proposed change will impair the ability of Members or competing venues to maintain their competitive standing in the financial markets. Further, excessive rates would serve to impair an exchange's ability to compete for order flow and members rather than burdening competition. The Exchange believes that its proposal would not burden intramarket competition because the proposal would apply uniformly to all Members.
The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The Exchange has not received any unsolicited written comments from Members or other interested parties.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) 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 Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
LCH SA is proposing to amend its Reference Guide: CDS Margin Framework (“CDSClear Margin Framework” or “Framework”) to adjust the wrong way risk (“WWR”) margin component of the Framework to more appropriately address offsets between currencies when calculating WWR margin.
In its filing with the Commission, LCH SA 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. LCH SA has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of these statements.
The WWR component of the Framework is designed to cover the anticipated financial contagion effect that would arise in case of a clearing member being declared in default. The current WWR margin formula acknowledges offsets as between currencies by allowing offset between WWR and right way risk (“RWR”). Specifically, a WWR currency offset is applied as the greater of: (x) the WWR amount in Euros minus the RWR amount in Euros, where non-Euro amounts are converted to Euros using a foreign exchange (“FX”) rate plus or minus a haircut; and (y) the WWR amount in Euros multiplied by 1 minus a factor, which represents the correlation between European and U.S. financial institutions by calculating the average historical cross correlation of credit spreads on credit default swaps (“CDS”) in respect of all pairs of European and U.S. financial institutions that are clearing members. Under the current calculation, if one currency has WWR and the other has RWR, LCH SA would compare the WWR amount as offset by the RWR to the WWR amount as reduced by taking the correlation factor into account and take the greater of the two. As a result, either the full amount of RWR is considered as offsetting the WWR, or only a portion of the WWR is taken into account without any regard to the expected amount of RWR.
LCH SA believes that it is appropriate to consider the offset between the WWR amount and RWR amount but it would not be appropriate to apply the correlation factor to discount the WWR amount while also allowing the RWR to offset the WWR amount to its full extent. To be conservative, LCH SA believes that it is appropriate to apply the correlation factor to the RWR amount when using RWR to offset the WWR amount. Accordingly, LCH SA proposes to modify the WWR currency offset formula in the Framework to be the greater of: (i) the WWR amount in Euros, where such amounts are converted to Euros using an FX rate plus or minus a haircut, minus (ii) the RWR amount multiplied by the 10-year average historical correlation of credit spreads on CDS in respect of European and U.S. financial institutions; and zero. As of April 2016, the 10-year average historical correlation of credit spreads on CDS in respect of European and U.S. financial institutions was set to 48 percent.
Under this approach, RWR would never completely offset WWR and instead would be discounted based on the average of observed correlations of CDS credit spreads in respect of European and U.S. financial institutions. LCH SA believes that this change rationalizes the WWR currency offset and results in a more conservative WWR margin calculation.
LCH SA believes that the proposed rule change is consistent with the requirements of Section 17A of the Securities Exchange Act of 1934
Moreover, LCH SA believes that the proposed rule change is consistent with the requirements in Rule 17Ad-22(e)(6).
Section 17A(b)(3)(I) of the Act requires that the rules of a clearing agency not impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
Written comments relating to the proposed rule change have not been solicited or received. LCH SA will notify the Commission of any written comments received by LCH SA.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove such proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-LCH SA-2017-009 and should be submitted on or before December 7, 2017.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), the Securities and Exchange Commission (“Commission”) is soliciting comments on the collections of information summarized below. The Commission plans to submit these existing collections of information to the Office of Management and Budget for extension.
Rule 31a-1 (17 CFR 270.31a-1) under the Investment Company Act of 1940 (the “Act”) (15 U.S.C. 80a) is entitled “Records to be maintained by registered investment companies, certain majority-owned subsidiaries thereof, and other persons having transactions with registered investment companies.” Rule 31a-1 requires registered investment companies (“funds”), and every underwriter, broker, dealer, or investment adviser that is a majority-owned subsidiary of a fund, to maintain and keep current accounts, books, and other documents which constitute the record forming the basis for financial statements required to be filed pursuant to section 31 of the Act (15 U.S.C. 80a-30) and of the auditor's certificates relating thereto. The rule lists specific records to be maintained by funds. The rule also requires certain underwriters, brokers, dealers, depositors, and investment advisers to maintain the records that they are required to maintain under federal securities laws.
There are approximately 4,029 investment companies registered with the Commission, all of which are required to comply with rule 31a-1. For purposes of determining the burden imposed by rule 31a-1, the Commission staff estimates that each fund is divided into approximately four series, on average, and that each series is required to comply with the recordkeeping requirements of rule 31a-1. Based on conversations with fund representatives, it is estimated that rule 31a-1 imposes an average burden of approximately 1,750 hours annually per series for a total of 7,000 annual hours per fund.
The estimate of average burden hours is made solely for the purposes of the Paperwork Reduction Act, and is not derived from a comprehensive or even a representative survey or study. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
Written comments are requested on: (a) Whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information has practical utility; (b) the accuracy of the Commission's estimate of the burden(s) of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
Please direct your written comments to Pamela Dyson, Director/Chief Information Officer, Securities and Exchange Commission, C/O Remi Pavlik-Simon, 100 F Street NE., Washington, DC 20549; or send an email to:
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The Investment Company Act of 1940 (the “Act”)
In one of its first releases, the Commission exercised its rulemaking authority pursuant to sections 38(a) and 40(b) of the Act by adopting rule 0-1 (17 CFR 270.0-1).
The Commission amended rule 0-1 to include the definition of the term “independent legal counsel” in 2001.
If the board's counsel has represented the fund's investment adviser, principal underwriter, administrator (collectively, “management organizations”) or their “control persons”
Any fund that relies on one of the exemptive rules must comply with the requirements in the definition of “independent legal counsel” under rule 0-1. We assume that approximately 3,108 funds rely on at least one of the exemptive rules annually.
These burden hour estimates are based upon the Commission staff's experience and discussions with the fund industry. The estimates of average burden hours are made solely for the purposes of the Paperwork Reduction Act. These estimates are not derived from a comprehensive or even a representative survey or study of the costs of Commission rules.
Compliance with the collection of information requirements of the rule is mandatory and is necessary to comply with the requirements of the rule in general. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.
The public may view the background documentation for this information collection at the following Web site,
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The title for the collection of information is “Form N-6F (17 CFR 274.15), Notice of Intent to Elect to be Subject to Sections 55 through 65 of the Investment Company Act of 1940.” The purpose of Form N-6F is to notify the Commission of a company's intent to file a notification of election to become subject to Sections 55 through 65 of the Investment Company Act of 1940 (15 U.S.C. 80a-1
The Commission estimates that on average approximately 12 companies file these notifications each year. Each of those companies need only make a single filing of Form N-6F. The Commission further estimates that this information collection imposes burden of 0.5 hours, resulting in a total annual PRA burden of 6 hours. Based on the estimated wage rate, the total cost to the industry of the hour burden for complying with Form N-6F would be approximately $2,070.
The collection of information under Form N-6F is mandatory. The information provided under the form is not kept confidential. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
The public may view the background documentation for this information collection at the following Web site,
On September 8, 2017, NYSE Arca, Inc. (“Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission finds that it is appropriate to designate a longer period within which to take action on the proposed rule change so that it has sufficient time to consider the proposed rule change. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange filed a proposal to amend the fee schedule applicable to Members
The text of the proposed rule change is available at the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant parts of such statements.
A physical port is utilized by a Member or non-Member to connect to the Exchange at the data centers where the Exchange's servers are located. The Exchange currently maintains a presence in two third-party data centers: (i) The primary data center where the Exchange's business is primarily conducted on a daily basis, and (ii) a secondary data center, which is predominantly maintained for business continuity purposes. The Exchange currently assesses the following physical connectivity fees for Members and non-Members on a monthly basis: $2,000 per physical port that connects to the System
The Exchange believes that the proposed rule change is consistent with the objectives of Section 6 of the Act,
The Exchange believes that the proposed rate is equitable and non-discriminatory in that it applies uniformly to all Members. Members and non-Members will continue to choose whether they want more than one physical port and choose the method of connectivity based on their specific needs. All Members that voluntarily select various service options will be charged the same amount for the same services. As is true of all physical connectivity, all Members and non-Members have the option to select any connectivity option, and there is no differentiation with regard to the fees charged for the service.
The Exchange believes that the proposal represents an equitable allocation of reasonable dues, fees, and other charges as its fees for physical connectivity are reasonably constrained by competitive alternatives. If a particular exchange charges excessive fees for connectivity, affected Members and non-Members may opt to terminate their connectivity arrangements with that exchange, and adopt a possible range of alternative strategies, including routing to the applicable exchange through another participant or market center or taking that exchange's data indirectly. Accordingly, if the Exchange charges excessive fees, it would stand to lose not only connectivity revenues but also revenues associated with the execution of orders routed to it, and, to the extent applicable, market data revenues. The Exchange believes that this competitive dynamic imposes powerful restraints on the ability of any exchange to charge unreasonable fees for connectivity.
Furthermore, the proposed rule change is also an equitable allocation of reasonable dues, fees, and other charges as the Exchange believes that the increased fees obtained will enable it to cover its increased infrastructure costs associated with establishing physical ports to connect to the Exchange's Systems. The additional revenue from the increased fee will also enable the Exchange to continue to maintain and improve its market technology and services.
Lastly, the Exchange believes the fees and credits remain competitive with those charged by other venues and therefore continue to be reasonable and equitably allocated to Members. For instance, the proposed fees for a 10 gigabyte circuit of $7,000 per month is less than analogous fees charged by the Nasdaq Stock Market LLC (“Nasdaq”) and NYSE Arca, Inc. (“Arca”), which range from $10,000—$15,000 per month for 10 gigabyte circuits.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. As discussed above, the Exchange believes that fees for connectivity are constrained by the robust competition for order flow among exchanges and non-exchange markets. The Exchange does not believe that the proposed changes represent a significant departure from previous pricing offered by the Exchange or pricing offered by the Exchange's competitors. Additionally, Members may opt to disfavor the Exchange's pricing if they believe that alternatives offer them better value. Further, excessive fees for connectivity would serve to impair an exchange's ability to compete for order flow rather than burdening competition.
The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The Exchange has not received any unsolicited written comments from Members or other interested parties.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) 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 Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 30b1-4 (17 CFR 270.30b1-4) under the Investment Company Act of 1940 (15 U.S.C. 80a-1
The Commission estimates that there are approximately 2,376 funds registered with the Commission, representing approximately 11,818 fund portfolios that are required to file Form N-PX reports. The 11,818 portfolios are comprised of approximately 7,111 portfolios holding equity securities, 3,249 portfolios holding no equity securities, and 1,458 portfolios holding fund securities (
The estimated cost burden of Form N-PX is $1,000 in external costs per portfolio holding equity securities that is paid to third-party service providers. External costs for portfolios holding no equity securities have previously been estimated to be zero because portfolios holding no equity securities generally have no proxy votes to report and therefore do not require third-party service providers to assist with proxy voting and preparing reports on Form N-PX. The estimated cost burden of Form N-PX for fund of funds is estimated to be $100 per portfolio because fund of funds generally either have no proxy votes to report; or if proxy votes are reported, they are generally limited in the number of securities and the number of voting matters relative to portfolios holding equity securities. Therefore, the aggregate cost burden, when calculated using the current number of portfolios, is approximately $7.3 million in external costs.
Estimates of average burden hours and costs are made solely for the purposes of the Paperwork Reduction Act and are not derived from a comprehensive or even representative survey or study of the costs of Commission rules and forms. Compliance with the collection of information requirements of Form N-PX is mandatory. Responses to the collection of information will not be kept confidential. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
The public may view the background documentation for this information collection at the following Web site,
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Rule 1059, Accommodation Transactions.
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 Rule 1059, Accommodation Transactions, which provides for cabinet trading
Exchange Rule 1059, Accommodation Transactions, sets forth specific procedures for engaging in cabinet trades. Rule 1059(a) currently provides that the specialist registered in each class of option contracts shall supervise the operation of the cabinet for that class, and that all orders placed in the cabinet are assigned priority based upon the sequence in which such orders are received by the specialist. It states that all closing bids and offers are to be submitted to the specialist in writing, and that the specialist effects all closing cabinet transactions by matching such orders placed with him. The rule provides that bids or offers on orders to open for the accounts of customer, firm, specialists and Registered Options Traders (“ROTs”) can be made at $1 per option contract, but that such orders cannot be placed in, and must yield to, all orders in the cabinet. Rule 1059(a) currently states that specialists shall effect all cabinet transactions by matching closing purchase or sale orders which are placed in the cabinet or, provided there is no matching closing purchase or sale order in the cabinet, by matching a closing purchase or sale order in the cabinet with an opening purchase or sale order. The rule states that all cabinet transactions are to be reported to the Exchange following the close of each business day.
Rule 1059(a), which prescribes the roles described above for the specialist in executing cabinet trades, is inconsistent with procedures currently followed in the execution of these trades. Because remote trading has become common in recent years, such that specialists are no longer present on the trading floor in all options, the procedures used to execute cabinet trades have evolved. Additionally, with the migration of the Exchange to a new electronic trading system (“Phlx XL II”) in 2009, the role of the Exchange specialist changed.
Accordingly, the Exchange proposes to delete a number of provisions of Rule 1059(a) which presume the participation of a specialist in every cabinet trade. First, the Exchange proposes to delete Rule 1059(a)(ii) which states that the specialist shall supervise the operation of the cabinet for that class, as well as the requirement in Rule 1059(a)(iii) that only closing limit orders at a price of $1 per option contract for the accounts of customer, firm, specialists and ROTs may be placed in the cabinet and that such orders be submitted to the specialist in writing. Next, it proposes to delete Rule 1059(a)(iv) dealing with the priority of orders received by the specialist and Rule 1059(a)(v), which states that all closing bids and offers must be submitted to the specialist in writing, and that the specialist shall effect all closing cabinet transactions by matching such orders placed with him. The provision in Rule 1059(a)(v) stating that bids or offers on orders to open for the accounts of customer, firm, specialists and ROTs may be made at $1 per option
The Exchange proposes to reorganize the rule for clarity and to add new language setting forth procedures that are currently followed on the trading floor to execute cabinet orders under Rule 1059. Rule 1059(a) would be revised to define the term “cabinet order” as a closing limit order at a price of $1 per option contract for the account of a customer, firm, specialist or ROT. This new definition is consistent with current Rule 1059(a)(iii) which, while not a definition, provides that only closing limit orders at a price of $1 per option contract for the accounts of customer, firm, specialists and ROTs may be placed in the cabinet. Rule 1059(a) would also specify that an opening order is not a “cabinet order” but may in certain cases be matched with a cabinet order pursuant to subsection (a)(iii) (as proposed to be amended). The rule would specify that only Floor Brokers may represent cabinet orders.
New Rule 1059(a)(ii) would be added, to provide that cabinet orders may be submitted to Floor Brokers and represented by them in the designated trading crowd of the option class and that Floor Brokers must use the designated cabinet transaction forms provided by the Exchange to document receipt of a cabinet order and the execution of a cabinet transaction. The new language would specify that Rule 1063(e)(i) shall not apply to orders placed in the cabinet or executed in the cabinet.
The Exchange proposes to add new Rule 1059(a)(iii), which specifies the procedures to be followed by the Floor Broker and other trading crowd participants to execute cabinet orders in three different scenarios. In each case, the Floor Broker would be required to act in the presence of at least one market-maker and NASDAQ Market Regulation Floor Surveillance.
Rule 1059(a)(iii)(A) governs cases where a Floor Broker holds a cabinet order but does not also hold contra-side interest. In that case, the Floor Broker shall announce the terms of the cabinet order to the trading crowd to solicit interest to participate on the closing position. All matching cabinet orders shall be assigned priority based upon the sequence in which such orders are received by the Floor Broker. If there is no matching cabinet order, the Floor Broker may match the cabinet order with a matching opening buy or sell limit order priced at $1 per option contract. If there is no matching cabinet order or opening order, the Floor Broker may seek matching bids or offers for accounts of specialists and ROTs. Specialists and ROTs can only participate after all other orders have been matched.
Rule 1059(a)(iii)(B) governs cases where a Floor Broker holds a cabinet order and also a contra-side cabinet order. In that situation, the rule would require the Floor Broker to announce the terms of the cabinet orders to the trading crowd. The cabinet orders shall then be immediately crossed by the Floor Broker.
Finally, Rule 1059(a)(iii)(C) applies where a Floor Broker holds both a cabinet order and a contra-side opening order. In that situation, the Floor Broker is required to announce the terms of the cabinet order to the trading crowd. If there is a matching cabinet order, the Floor Broker shall match the two cabinet orders. If there is no matching cabinet order, the cabinet order shall then be immediately crossed by the Floor Broker with the opening order held by the Floor Broker.
The proposed amendments describing the updated cabinet trading procedures will change the current cabinet priority rules in some respects. Currently, specialists match all orders represented by all floor brokers on the floor, based first on time, then on opening vs. closing. The specialist is required to assign priority to all orders placed in the cabinet based upon the sequence in which such orders are received by the specialist. The specialist is then to match cabinet orders first against matching cabinet orders, and second, if there is no matching cabinet order, against a matching opening order.
The proposed priority rules focus on the cabinet order at the time it is represented by a floor broker in the trading crowd. Thus, as proposed, each floor broker holding a cabinet order only would be required to assign priority to cabinet orders he holds based upon the sequence in which he receives such orders, consistent with the current rule's requirement for specialists, but would not be required to cede priority to a cabinet order represented in the crowd at an earlier time by another Floor Broker.
The floor broker is then to assign matching cabinet orders from the crowd based upon the sequence in which the orders are received by that floor broker representing such order. For example, the “Floor Broker A” receives a cabinet order to buy 500 contracts and represents to the trading crowd. At the time of representation to the crowd, “Floor Broker B” has a matching cabinet order for 250 contracts and “Floor Broker C” enters the trading crowd after “Floor Broker B” with a matching cabinet order for 500 contracts. “Floor Broker A” then proceeds to match his 500 contracts to buy cabinet order with the matching cabinet order from “Floor Broker B” for 250 contracts and matching the balance of 250 contracts with “Floor Broker C”. The Floor Broker matched the cabinet orders based on the sequence in which the orders were received in the crowd at the time the cabinet order was represented. If there are no matching cabinet orders from the crowd, the floor broker may match the cabinet order with a matching opening order from the crowd. If however the floor broker holds both a cabinet order and a contra side cabinet order, the floor broker would be required to immediately cross those orders after announcing their terms in the crowd, regardless of cabinet orders held by other floor brokers. This represents a change to the priority scheme under the current cabinet rule.
The Exchange is proposing a number of additional, minor changes to Rule 1059. New Rule 1059(a)(iv) would require the Floor Broker, once the cabinet order has been either crossed or matched, to submit the designated cabinet form to the Nasdaq Market Operations staff for clearance and reporting at the close of the business day. Current Rule 1059(a)(viii), which provides that all cabinet transactions shall be reported to the Exchange following the close of each business day, would be deleted. Finally, Rule 1059(a)(vii) would be redesignated as Rule 1059(a)(v) and would be revised to delete an erroneous and outdated cross-
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The role of the specialist has changed on the Exchange, and specialists are no longer present in all options classes on the Exchange's trading floor. The proposed rule change would maintain market participants' ability to execute cabinet transactions on the Exchange's trading floor, in an open manner and in compliance with new procedures specified in the revised rule.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule change permits market participants to continue to execute cabinet trades on the Exchange, even without the participation of specialists. The proposed amendments will apply to all Floor Brokers equally and in the same way. Phlx notes that market participants may also execute cabinet transactions on other exchanges.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Rule 17f-2(d) requires that records created pursuant to the fingerprinting requirements of Section 17(f)(2) of the Act be maintained and preserved by every member of a national securities exchange, broker, dealer, registered transfer agent and registered clearing agency (“covered entities” or “respondents”); permits, under certain circumstances, the records required to be maintained and preserved by a member of a national securities exchange, broker, or dealer to be maintained and preserved by a self-regulatory organization that is also the designated examining authority for that member, broker or dealer; and permits the required records to be preserved on microfilm. The general purpose of Rule 17f-2 is to: (i) Identify security risk personnel; (ii) provide criminal record information so that employers can make fully informed employment decisions; and (iii) deter persons with criminal records from seeking employment or association with covered entities. The rule enables the Commission or other examining authority to ascertain whether all covered persons are being fingerprinted and whether proper procedures regarding fingerprinting are being followed. Retention of these records for a period of not less than three years after termination of a covered person's employment or relationship with a covered entity ensures that law enforcement officials will have easy access to fingerprint cards on a timely basis. This in turn acts as an effective deterrent to employee misconduct.
Approximately 4,200 respondents are subject to the recordkeeping requirements of the rule. Each respondent maintains approximately 68 new records per year, each of which takes approximately 2 minutes per record to maintain, for an annual burden of approximately 2.2666667 hours (68 records times 2 minutes). The total annual burden for all respondents is approximately 9,520 (4,200 respondents times 2.2666667 hours). As noted above, all records maintained subject to the rule must be retained for a period of not less than three years after termination of a covered person's employment or relationship with a covered entity. In addition, we estimate the total cost to respondents is approximately $42,000 in third party storage costs.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
The public may view background documentation for this information collection at the following Web site:
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), the Securities and Exchange Commission (the “Commission”) has submitted to the Office of Management and Budget a request for extension of the previously approved collection of information discussed below.
Section 19(a) (15 U.S.C. 80a-19(a)) of the Investment Company Act of 1940 (the “Act”)
Rule 19a-1 (17 CFR 270.19a-1) under the Act, entitled “Written Statement to Accompany Dividend Payments by Management Companies,” sets forth specific requirements for the information that must be included in statements made pursuant to section 19(a) by or on behalf of management companies.
The purpose of rule 19a-1 is to afford fund shareholders adequate disclosure of the sources from which distribution payments are made. The rule is intended to prevent shareholders from confusing income dividends with distributions made from capital sources. Absent rule 19a-1, shareholders might receive a false impression of fund gains.
Based on a review of filings made with the Commission, the staff estimates that approximately 11,818 series of registered investment companies that are management companies may be subject to rule 19a-1 each year,
The staff estimates that approximately one-third of the total annual burden (7,879 hours) would be incurred by a paralegal with an average hourly wage rate of approximately $205 per hour,
To comply with state law, many investment companies already must distinguish the different sources from which a shareholder distribution is paid and disclose that information to shareholders. Thus, many investment companies would be required to distinguish the sources of shareholder dividends whether or not the Commission required them to do so under rule 19a-1.
The estimate of average burden hours is made solely for the purposes of the Paperwork Reduction Act, and is not derived from a comprehensive or even a representative survey or study of the costs of Commission rules. Compliance with the collection of information required by rule 19a-1 is mandatory for management companies that make statements to shareholders pursuant to section 19(a) of the Act. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.
The public may view the background documentation for this information collection at the following Web site,
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange filed a proposal to amend the fee schedule applicable to Members
The text of the proposed rule change is available at the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant parts of such statements.
A physical port is utilized by a Member or non-Member to connect to the Exchange at the data centers where the Exchange's servers are located. The Exchange currently maintains a presence in two third-party data centers: (i) The primary data center where the Exchange's business is primarily conducted on a daily basis, and (ii) a secondary data center, which is predominantly maintained for business continuity purposes. The Exchange currently assesses the following physical connectivity fees for Members and non-Members on a monthly basis: $2,000 per physical port that connects to the System
The Exchange believes that the proposed rule change is consistent with the objectives of Section 6 of the Act,
The Exchange believes that the proposed rate is equitable and non-discriminatory in that it applies uniformly to all Members. Members and non-Members will continue to choose whether they want more than one physical port and choose the method of connectivity based on their specific needs. All Members that voluntarily select various service options will be charged the same amount for the same services. As is true of all physical connectivity, all Members and non-Members have the option to select any connectivity option, and there is no differentiation with regard to the fees charged for the service.
The Exchange believes that the proposal represents an equitable allocation of reasonable dues, fees, and other charges as its fees for physical connectivity are reasonably constrained by competitive alternatives. If a particular exchange charges excessive fees for connectivity, affected Members and non-Members may opt to terminate their connectivity arrangements with that exchange, and adopt a possible range of alternative strategies, including routing to the applicable exchange through another participant or market center or taking that exchange's data indirectly. Accordingly, if the Exchange charges excessive fees, it would stand to lose not only connectivity revenues but also revenues associated with the execution of orders routed to it, and, to the extent applicable, market data revenues. The Exchange believes that this competitive dynamic imposes powerful restraints on the ability of any exchange to charge unreasonable fees for connectivity.
Furthermore, the proposed rule change is also an equitable allocation of reasonable dues, fees, and other charges as the Exchange believes that the increased fees obtained will enable it to cover its increased infrastructure costs associated with establishing physical ports to connect to the Exchange's Systems. The additional revenue from the increased fee will also enable the Exchange to continue to maintain and improve its market technology and services.
Lastly, the Exchange believes the fees and credits remain competitive with those charged by other venues and therefore continue to be reasonable and equitably allocated to Members. For instance, the proposed fees for a 10 gigabyte circuit of $7,000 per month is less than analogous fees charged by the Nasdaq Stock Market LLC (“Nasdaq”) and NYSE Arca, Inc. (“Arca”), which range from $10,000—$15,000 per month for 10 gigabyte circuits.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. As discussed above, the Exchange believes that fees for connectivity are constrained by the robust competition for order flow among exchanges and non-exchange markets. The Exchange does not believe that the proposed changes represent a significant departure from previous pricing offered by the Exchange or pricing offered by the Exchange's competitors. Additionally, Members may opt to disfavor the Exchange's pricing if they believe that alternatives offer them better value. Further, excessive fees for connectivity would serve to impair an exchange's ability to compete for order flow rather than burdening competition.
The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The Exchange has not received any unsolicited written comments from Members or other interested parties.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) 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 Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On May 1, 2017,
Section 19(b)(2) of the Act
The Commission is extending the 180-day time period for Commission action on each of the proposed rule changes. The Commission finds it appropriate to designate a longer period within which to issue an order approving or disapproving the proposed rule changes so that it has sufficient time to consider the proposed rule changes, the issues raised in the comment letters that have been submitted in connection therewith, the Participants' response to the comments, and the amendments to the proposed rule changes.
Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Form N-17f-1 (17 CFR 274.219) is entitled “Certificate of Accounting of Securities and Similar Investments of a Management Investment Company in the Custody of Members of National Securities Exchanges.” The form serves as a cover sheet to the accountant's certificate that is required to be filed periodically with the Commission pursuant to rule 17f-1 (17 CFR 270.17f-1) under the Act, entitled “Custody of Securities with Members of National Securities Exchanges,” which sets forth the conditions under which a fund may place its assets in the custody of a member of a national securities exchange. Rule 17f-1 requires, among other things, that an independent public accountant verify the fund's assets at the end of every annual and semi-annual fiscal period, and at least one other time during the fiscal year as chosen by the independent accountant. Requiring an independent accountant to examine the fund's assets in the custody of a member of a national securities exchange assists Commission staff in its inspection program and helps to ensure that the fund assets are subject to proper auditing procedures. The accountant's certificate stating that it has made an examination, and describing the nature and the extent of the examination, must be attached to Form N-17f-1 and filed with the Commission promptly after each examination. The form facilitates the filing of the accountant's certificates, and increases the accessibility of the certificates to both Commission staff and interested investors.
The estimate of average burden hours is made solely for the purposes of the Paperwork Reduction Act, and is not derived from a comprehensive or even a representative survey or study of the costs of Commission rules. Compliance with the collections of information required by Form N-17f-1 is mandatory for funds that place their assets in the custody of a national securities exchange member. Responses will not be kept confidential. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid control number.
The Commission requests written comments on: (a) Whether the collections of information are necessary for the proper performance of the functions of the Commission, including whether the information has practical utility; (b) the accuracy of the Commission's estimate of the burdens of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or
Please direct your written comments to Pamela Dyson, Director/Chief Information Officer, Securities and Exchange Commission, C/O Remi Pavlik-Simon, 100 F Street NE., Washington, DC 20549; or send an email to:
National Women's Business Council, Small Business Administration.
Notice of open public meeting.
The Public Meeting teleconference will be held on Thursday, December 7, 2017 from 2:00 p.m. to 4:00 p.m. EST.
The meeting will be held via teleconference.
The meeting is open to the public; however advance notice of attendance is requested. To RSVP and confirm attendance, the general public should email
For more information, please visit the National Women's Business Council Web site at
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C., Appendix 2), the U.S. Small Business Administration (SBA) announces the meeting of the National Women's Business Council. The National Women's Business Council conducts research on issues of importance and impact to women entrepreneurs and makes policy recommendations to the SBA, Congress, and the White House on how to improve the business climate for women.
This meeting is the 1st Quarter meeting for Fiscal Year 2018. The online meeting will provide stakeholders with updates on the Council's research and engagement activities. Time will be reserved at the end for audience participants to address Council Members, directly, with questions, comments, or feedback.
Pursuant to the authority granted to the United States Small Business Administration under the Small Business Investment Act of 1958, as amended, under Section 309 of the Act and Section 107.1900 of the Small Business Administration Rules and Regulations (13 CFR 107.1900) to function as a small business investment company under the Small Business Investment Company License No. 09/79-0438 issued to Grayhawk Venture Fund I, L.P. said license is hereby declared null and void.
U.S. Small Business Administration.
Amendment 8.
This is an amendment of the Presidential declaration of a major disaster for the State of Texas (FEMA-4332-DR), dated 08/25/2017.
Issued on 11/07/2017.
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, (202) 205-6734.
The notice of the President's major disaster declaration for the State of Texas, dated 08/25/2017, is hereby amended to extend the deadline for filing applications for physical damages as a result of this disaster to 11/30/2017.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Amendment 4.
This is an amendment of the Presidential declaration of a major disaster for the State of California (FEMA-4344-DR), dated 10/12/2017.
Issued on 11/07/2017.
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, (202) 205-6734.
The notice of the President's major disaster declaration for the State of California, dated 10/12/2017, is hereby amended to establish the incident period for this disaster as beginning 10/08/2017 through 10/31/2017.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Kansas (FEMA-4347-DR), dated 11/07/2017.
Issued on 11/07/2017.
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, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on 11/07/2017, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 153766 and for economic injury is 153770.
Pursuant to the authority granted to the United States Small Business Administration under the Small Business Investment Act of 1958, as amended, under Section 309 of the Act and Section 107.1900 of the Small Business Administration Rules and Regulations (13 CFR 107.1900) to function as a small business investment company under the Small Business Investment Company License No. 09/79-0448 issued to Shepherd Ventures II, LP, said license is hereby declared null and void.
Department of State.
Notice.
The Acting Assistant Secretary of State for Oceans and International Environmental and Scientific Affairs, acting pursuant to delegated authorities, issued a Presidential permit to Enbridge Energy, Limited Partnership (“Enbridge”) on October 13, 2017, authorizing Enbridge to operate and maintain pipeline facilities at the U.S.-Canada border in Pembina County, North Dakota for the transportation of crude oil and other hydrocarbons. In accordance with Executive Order 13337 (April 30, 2004), the Acting Assistant Secretary determined that issuance of this permit would serve the national interest.
Richard W. Westerdale II, Bureau of Energy Resources, U.S. Department of State, 2201 C St. NW., Suite 4422, Washington, DC 20520, (202) 647-7947.
Additional information concerning the Enbridge pipeline facilities and documents related to the Department of State's review of the application for a Presidential permit can be found at
By virtue of the authority vested in me as Acting Assistant Secretary of State for Oceans and International Environmental and Scientific Affairs, including those authorities under Executive Order 13337, 69 FR 25299 (2004), Department of State Delegation of Authority 118-2 of January 26, 2006, and Department of State Delegation of Authority 415 of January 18, 2017; having considered the environmental effects of the proposed action consistent with the National Environmental Policy Act of 1969 (83 Stat. 852; 42 U.S.C. 4321
The term “facilities” as used in this permit means the relevant portion of the pipeline and any land, structures, installations or equipment appurtenant thereto.
The term “United States facilities” as used in this permit means those parts of the facilities located in the United States. The United States facilities consist of a 36-inch
The United States facilities also include certain appurtenant facilities, including such metering facilities as are required by the Commissioner of U.S. Customs and Border Protection.
This permit is subject to the following conditions:
(2) The operation and maintenance of the United States facilities shall be in all material respects as described in the permittee's application for a Presidential permit under Executive Order 13337, filed on November 20, 2012, as amended on June 16, 2014, the Final Supplemental Environmental Impact Statement (SEIS) dated August 11, 2017, including all Appendices as supplemented, and any measures to mitigate adverse impacts included in the permittee's policies, plans, and procedures for pipeline maintenance and operation, such as the permittee's Integrated Contingency Plan, Environmental Mitigation Plan (Pipeline Maintenance Projects), Operations and Maintenance Manuals, Unanticipated Discovery Plans, and other mitigation and control plans that are already approved or that are approved in the future by the Department of State or other relevant federal agencies. In the event of any discrepancy among these documents, operation and maintenance of the United States facilities shall be in all material respects as described in the most recent approved document unless otherwise determined by the Department of State.
(2) The permittee shall hold harmless and indemnify the United States from any claimed or adjudged liability arising out of construction, connection, operation, or maintenance of the facilities, including but not limited to environmental contamination from the release or threatened release or discharge of hazardous substances and hazardous waste.
(3) The permittee shall maintain the United States facilities and every part thereof in a condition of good repair for their safe operation, and in compliance with prevailing environmental standards and regulations.
Notice is hereby given of the following determinations: I hereby determine that a certain object to be included in the exhibition “Rembrandt's Self-Portrait at the Age of 34,” imported from abroad for temporary exhibition within the United States, is of cultural significance. The object is imported pursuant to a loan agreement with the foreign owner or custodian. I also determine that the exhibition or display of the exhibit object at the Norton Simon Museum of Art, Pasadena, California, from on or about December 7, 2017, until on or about March 5, 2018, and at possible additional exhibitions or venues yet to be determined, is in the national interest.
Elliot Chiu in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
Federal Aviation Administration (FAA), DOT.
Notice.
The FAA is considering a proposal to change a 29.429-acre portion of airport land from aeronautical use to non-aeronautical use and to authorize the sale of airport property located at Aurora Municipal Airport, Sugar Grove, IL.
The subject portion of airport property considered for release from obligation to be maintained for aeronautical use and sale includes a 26.67-acre portion of Parcel 33, a 0.69-acre portion of Parcel 10, and a 2.069-acre portion of Parcel 11 that are located in the northwest quadrant of the airport along Wheeler Road and currently not being used directly for aeronautical purposes. Currently, ownership of the property provides for protection of FAR Part 77 surfaces and compatible land use which would continue to be protected with deed restrictions required in the transfer of land ownership. The change from aeronautical to non-aeronautical use would allow for the more efficient use of existing airport property. The aforementioned land is not needed for aeronautical use.
Comments must be received on or before December 18, 2017.
Documents are available for review by prior appointment at the FAA Airports District Office, Mr. Richard Pur, Airports Engineer, Federal Aviation Administration, Chicago Airports District Office, 2300 East Devon Avenue, Des Plaines, IL 60018. Telephone: (847) 294-7527/Fax: (847) 294-7046, and Aurora Municipal Airport, 43 W 636 US 30, Sugar Grove, IL 60554. Telephone: (630) 466-7000/Fax: (630) 466-1166.
Mr. Richard Pur, Airports Engineer, Federal Aviation Administration, Chicago Airports District Office, 2300 East Devon Avenue, Des Plaines, IL 60018. Telephone: (847) 294-7527/Fax: (847) 294-7046.
In accordance with section 47107(h) of Title 49, United States Code, this notice is required to be published in the
The acquisition of Parcel 33 (102.77 acres) was originally funded under Federal AIP Grant 3-17-0003-B7 in 1992, with the original Parcel 10 (120.00 acres) acquisition funded under Federal AIP Grant 3-17-0003-B10 in 1999, and the original Parcel 11 (40.00 acres) acquisition funded under Federal AIP Grant 3-17-0006-B10 in 1999. The subject portions of those parcels are currently used for FAR Part 77 protection and to ensure compatible land use. The City of Aurora plans to sell the subject property to the Village of Sugar Grove. Fair Market Value will be obtained from the sale of the subject property.
This notice announces that the FAA is considering the release of the subject airport property at Aurora Municipal Airport, Sugar Grove, IL, from Federal land covenants, subject to a reservation for continuing right of flight as well as restrictions on the released property as required in FAA Order 5190.6B Section 22.16. Approval does not constitute a commitment by the FAA to financially assist in the disposal of the subject airport property nor a determination of eligibility for grant-in-aid funding from the FAA. The use of the revenue generated from the sale of the airport property will be in accordance with FAA's Policy and Procedures concerning the Use of Airport Revenue, published in the
That part of the Southwest Fractional Quarter of Section 7, Township 38 North, Range 7 East of the Third Principal Meridian, Kane County, IL, more particularly described as follows.
Commencing at the northwest corner of the Southwest Fractional Quarter of Section 7, Township 38 North, Range 7 East of the Third Principal Meridian; thence North 89 degrees 35 minutes 16 seconds East along the north line of said Southwest Fractional Quarter, 286.50 feet to the Point of Beginning; thence continuing North 89 degrees 35 minutes 16 seconds East, 1383.22 feet to the northeast corner of said Southwest Fractional Quarter; thence South 00 degrees 35 minutes 03 seconds East along the east line of said Southwest Fractional Quarter, 1070.00 feet; thence South 89 degrees 35 minutes 16 seconds West, 712.41 feet; thence North 32 degrees 37 minutes 11 seconds West, 61.09 feet; thence northwesterly on a curve to the left having a radius of 494.40 feet, an arc length of 638.91 feet, the chord of said curve bears North 32 degrees 37 minutes 11 seconds West a distance of 595.37 feet; thence North 32
Part of the Northeast Quarter of Section 18, Township 38 North, Range 7 East of the Fourth Principal Meridian, Kane County, IL.
Commencing at the Northwest Corner of said Northeast Quarter of Section 18; thence North 89 degrees 34 minutes 19 seconds East along the North Line of said Northeast Quarter, a distance of 133.53 feet to the Point of Beginning; thence North 89 degrees 34 minutes 19 seconds East along said North Line, a distance of 868.30 feet; thence 75.00 feet along a curve concave to the Southeast, having a radius of 508.72 feet, a central angle of 8 degrees 26 minutes 50 seconds and the long chord of said bears South 63 degrees 42 minutes 36 seconds West, a chord distance of 74.93 feet; thence South 59 degrees 29 minutes 12 seconds West, a distance of 204.31 feet; thence South 30 degrees 30 minutes 48 seconds East, a distance of 1.00 foot; thence South 59 degrees 29 minutes 12 seconds West, a distance of 16.00 feet; thence North 30 degrees 30 minutes 48 seconds West, a distance of 1.00 foot; thence South 59 degrees 29 minutes 12 seconds West, a distance of 28.95 feet; thence 650.32 feet along a curve concave to the North, having a radius of 426.72 feet, a central angle of 87 degrees 19 minutes 08 seconds and the long chord of said curve bears North 76 degrees 51 minutes 15 seconds West, a chord distance of 589.19 feet; thence North 33 degrees 11 minutes 41 seconds West, a distance of 23.02 feet to the Point of Beginning, containing 2.759 acres, more or less.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of renewal of exemption, request for comments.
FMCSA announces its decision to renew for a period of 5 years Ford Motor Company's (Ford) current exemption allowing motor carriers to operate Ford's Transit-based commercial motor vehicles (CMV) that do not meet the exhaust system location requirements in the Federal Motor Carrier Safety Regulations (FMCSR). The FMCSRs require (1) the exhaust system of a bus powered by a gasoline engine to discharge to the atmosphere at or within 6 inches forward of the rearmost part of the bus and (2) the exhaust system of every truck and truck tractor to discharge to the atmosphere at a location to the rear of the cab or, if the exhaust projects above the cab, at a location near the rear of the cab. Although the Ford Transit does not meet these requirements, it has undergone performance-based testing that demonstrates that the exhaust system achieves a level of safety equivalent to, or greater than, the level of safety that would be obtained by complying with the regulation. Ford performed carbon monoxide (CO) concentration tests, which used CO monitors at various locations within the vehicle to measure the concentration of CO ingress into the occupant compartment (from the vehicles' own powertrain and exhaust system), under various driving conditions including idle and top speed. The tests showed that the resulting CO concentration is below every threshold used by Federal Agencies. The Agency has concluded that granting this exemption renewal will maintain a level of safety equivalent to, or greater than, the level of safety provided by the rule restricting the location of exhaust systems on CMVs to ensure that exhaust fumes will not affect the driver's alertness or health or the health of passengers.
The renewal outlined in this notice extends the exemption from August 15, 2017, through August 15, 2022. Comments on the decision must be received on or before December 18, 2017.
You may submit comments bearing the Federal Docket Management System (FDMS) Docket ID FMCSA-2015-0111 using any of the following methods:
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Mr. Luke Loy, Vehicle and Roadside Operations Division, Office of Carrier, Driver, and Vehicle Safety, MC-PSV, (202) 366-0676, Federal Motor Carrier Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
Section 4007 of the Transportation Equity Act for the 21st Century (TEA- 21) [Pub. L. 105-178, June 9, 1998, 112 Stat. 401] amended 49 U.S.C. 31315 and
The Agency reviews the safety analyses and the public comments and determines whether granting the exemption would likely achieve a level of safety equivalent to or greater than the level that would be achieved by the current regulation (49 CFR 381.305).
The decision of the Agency must be published in the
On December 1, 2014, Ford applied for an exemption from 49 CFR 393.83 to allow motor carriers to operate Ford-manufactured Transit-based CMVs that do not comply with the exhaust system location requirements. Section 393.83, “Exhaust systems,” includes requirements regarding the location of exhaust systems on CMVS to ensure that exhaust fumes will not affect the driver's alertness or health or the health of passengers. Specifically, § 393.83(c) states that “[t]he exhaust system of a bus powered by a gasoline engine shall discharge to the atmosphere at or within 6 inches forward of the rearmost part of the bus”; and § 393.83(e) states that “[t]he exhaust system of every truck and truck tractor shall discharge to the atmosphere at a location to the rear of the cab or, if the exhaust projects above the cab, at a location near the rear of the cab.” According to the 2014 exemption application:
Although Ford Transit vehicles may not satisfy the exhaust system location requirements of § 393.83, Ford has several internal requirements applicable to the design of the tailpipe system that ensure the system will provide high levels of safety for its customers. Ford's requirements address passenger compartment exhaust gas intrusion and management of high temperature components. These requirements include testing of the system and basic design requirements for the location of the tailpipe in relation to underbody components like the brake lines and fuel lines. Most significantly Ford uses internal performance based tests that demonstrate the system achieves a level of safety equivalent to or greater than, the level of safety that would be obtained by complying with the regulation. The main test of interest is the Carbon Monoxide Concentration test. This performance based test uses CO monitors at various locations in the vehicle to measure the concentration of CO ingress into the occupant compartment (from vehicles' own powertrain and exhaust system) under various driving conditions including idle and top speed.
Ford tested the 2015 model year Transit in accordance with “Ford global common engineering test procedures,” which limits CO levels to 27 parts-per-million (ppm) for a 30 minute Time Weighted Average (TWA) during continuous driving. Ford stated that the 27 ppm limit is based on the Environmental Protection Agency's (EPA) Acute Exposure Guideline Level limits for CO exposure for 8 hour TWA, which is more severe than both the Occupational Safety & Health Administration's (OSHA) permissible exposure limit of 50 ppm for an 8 hour TWA and the National Institute of Occupational Safety and Health's (NIOSH) permissible exposure limit of 35 ppm for a 10 hour TWA. Under “worst-case conditions,” Ford measured the CO level to be 17 ppm for the model year 2015 Transit, well below the EPA, OSHA, and NIOSH limits.
Additionally, Ford stated that it has internal requirements to establish the appropriate clearance required between a vehicle and the ground to meet a minimum level of on-road functionality. Ford has specific departure angle requirements for the vehicle to reduce tailpipe contact with the ground, curbs, ramps, etc., during various driving modes, thus avoiding damage to the exhaust system that may adversely affect the exhaust function.
FMCSA published a notice of the application in the
At the time the exemption was granted, the term of temporary exemptions was limited by statute to a maximum of 2 years. However, on December 4, 2015, President Obama signed the Fixing America's Surface Transportation (FAST) Act, which now allows an exemption to be granted for a period of 5 years (49 U.S.C. 31315(b)(2)) if FMCSA finds “such exemption would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption” (31315(b)(1)). Ford has requested a 5-year extension for the exemption from 49 CFR 393.83 to allow motor carriers to operate model year 2015 Ford-manufactured Transit-based CMVs, and later model year Transit-based models that do not comply with the exhaust system location requirements.
FMCSA is not aware of any evidence showing that the operation of model year 2015, 2016, or 2017 Ford Transit-based gas bus models (all gross vehicle weight ratings), vans over 10,000 pounds gross vehicle weight rating, and Transit-based models of the same design produced during the current exemption has resulted in any degradation of safety. The Agency believes that extending the exemption for a period of 5 years will likely achieve a level of safety that is equivalent to, or greater than, the level of safety achieved without the exemption. Performance-based testing conducted by Ford has demonstrated that the design of the exhaust system for the model year 2015 and later Ford Transit CMVs (1) results in CO exposure limits that are well below EPA, OSHA, and NIOSH established thresholds, and (2) will maintain a level of safety that is
The renewal outlined in this notice extends the exemption from August 12, 2017 through August 12, 2022, and requests public comment. The exemption will be valid for 5 years unless rescinded earlier by FMCSA. The exemption will be rescinded if: (1) Motor carriers and/or commercial motor vehicles fail to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained before it was granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315.
In accordance with 49 U.S.C. 31313(d), as implemented by 49 CFR 381.600, during the period this exemption is in effect, no State shall enforce any law or regulation applicable to interstate commerce that conflicts with or is inconsistent with this exemption with respect to a firm or person operating under the exemption. States may, but are not required to, adopt the same exemption with respect to operations in intrastate commerce.
FMCSA requests comments from parties with data concerning the safety record of motor carriers operating Model Year 2015 Ford-manufactured Transit based CMVs, and corresponding future Transit-based models of the same design in accordance with the conditions of the exemption. The Agency will evaluate adverse evidence submitted during the comment period and at any time during the 5-year period of the exemption. If safety is being compromised or if continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315(b)(1), FMCSA will take immediate steps to revoke the Ford exemption.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation.
Notice of receipt of petition; notice of receipt of request for deferral and of decision denying request for deferral.
On July 10, 2017, Takata Corporation (“Takata”) filed a defect information report (“DIR”) in which it determined that a safety-related defect exists in certain phase-stabilized ammonium nitrate (“PSAN”) driver-side airbag inflators that it manufactured with a calcium sulfate desiccant, including inflators that it supplied to Ford Motor Company (“Ford”), Mazda North American Operations (“Mazda”), and Nissan North America Inc. (“Nissan”) for use in certain vehicles. Mazda's vehicles identified by Takata's DIR were designed by Ford and were built on the same platform and using the same airbag inflators as the affected Ford vehicles. Mazda has petitioned the Agency—in part through a purported joint petition with Ford (see DOCKET NO. NHTSA-2017-0093)—for a decision that because analysis of inflators installed in certain Ford vehicles does not demonstrate propellant-tablet density degradation or increased inflation pressure, and because there are design differences between the inflators installed in Ford and Mazda vehicles and an inflator variant installed in Nissan vehicles, the equipment defect determined to exist by Takata is inconsequential as it relates to motor vehicle safety in the Mazda vehicles affected by Takata's DIR. Mazda requests relief from its notification and remedy obligations under the National Traffic and Motor Vehicle Safety Act of 1966 and its applicable regulations, and further requests that the Agency defer a decision on the petition until March 31, 2018 to allow Ford to complete certain analysis and testing.
The closing date for comments is December 18, 2017.
Interested persons are invited to submit written data, views, and arguments regarding this petition for inconsequentiality. Comments must refer to the docket and notice number cited in the title of this notice and be submitted by one of the following methods:
•
•
•
•
You may call the Docket at (202) 366-9324.
Note that all comments received will be posted without change to
The petition, supporting materials, and all comments received before the close of business on the closing date indicated above will be filed in the docket and will be considered. Comments and supporting materials received after the closing date will also be filed and will be considered to the extent possible. When the petition is granted or denied, notice of the decision will also be published in the
For general information regarding NHTSA's investigation into Takata airbag inflator ruptures and the related recalls, visit
On November 3, 2015, NHTSA issued, and Takata agreed to, a Consent Order setting forth penalties, requirements, and performance obligations in connection with Takata's alleged failure to fully comply with the National Traffic and Motor Vehicle Safety Act of 1966 as amended and recodified (the “Safety Act”), 49 U.S.C. 30101,
In February 2016, NHTSA requested Ford's assistance in evaluating Takata calcium-sulfate desiccated PSDI-5 driver-side airbag inflators, to which Ford agreed.
Takata has analyzed over 400 such inflators from the Ford program—as well as 895 such inflators from the Nissan program.
Takata's DIR filing triggered Mazda's obligation to file a DIR for its affected vehicles.
Under 49 CFR 556.4(c), Mazda was required to submit its Petition to NHTSA no later than thirty days after Mazda determined a defect exists. Mazda made the defect determination on July 18, 2017, which allowed it until August 17, 2017 to submit a petition to the Agency.
Despite this procedural flaw, and with the public interest in mind, NHTSA acknowledges receipt of Mazda's Petition, is publishing the relevant documents for public comment, and addresses Mazda's request for the Agency to defer a decision on the Petition. NHTSA need not decide herein whether the timing of Mazda's filing is fatal to its Petition—that issue is preserved for decision at a later date.
Mazda's Petition involves 5,848 vehicles in which the covered Mazda inflators were originally installed. Petition at 1. Those vehicles are MY 2007-2009 B-Series pickup trucks, which Mazda explains were built on the same platform and using the same airbag inflators as Ford MY 2007-2011 Rangers.
In support of its Petition, Mazda largely refers NHTSA to the “joint petition” with Ford enclosed with Mazda's letter.
In the “joint petition” enclosed with Mazda's letter, Ford argues that Takata's DIR does not determine the covered Ford inflators “actually contain a defect at this time, or that they will develop one over time,” and that once Ford completes its engineering analysis (by the end of March 2018), it will be able to supplement or amend its Petition to “allow the Agency to make a determination” on its Petition.
Ford's position in the “joint petition” is that the defect is inconsequential rests on two related arguments. First, in contrast to testing data pertaining to the covered Nissan inflators, Ford contends Takata's analysis of the covered Ford inflators does not show propellant-tablet density degradation or increased inflation pressure.
Second, and relatedly, Ford contends “[t]here are design differences” in the covered Ford inflators when compared to the covered Nissan inflators, and that such differences may explain differences observed between the two inflator variants during testing.
The remainder of the “joint petition” enclosed with Mazda's letter explains Ford's “commit[ment] to further investigation of PSDI-5 airbag inflators.”
Mazda requests in its letter that, “in conjunction with [its] joint petition filing with” Ford, NHTSA allow Mazda additional time before deciding on its Petition—specifically, until March 31, 2018—so Ford may “complete its expanded inflator field study, aging assessment, and testing on additional samples.” Petition at 1. Mazda also refers to “Ford's commitment to further investigation of PSDI-5 inflators through additional parts acquisitions as well as continued testing and engineering analysis.”
In the “joint petition,” Ford makes the same request for a deferral as Mazda, so that it (Ford) may “complete its intensified and expanded inflator field study, aging assessment, and testing on additional samples and vehicle types to evaluate the performance of the Takata desiccated PSDI-5 driver airbag inflators.”
The Agency recognizes Ford's plans to expand its investigation and to secure a supply of remedy inflators for affected vehicles if it becomes needed.
Specifically, NHTSA does not find the request for deferral reasonable under the circumstances or supported by the testing and data collected to date. Indeed, Ford does not provide an explanation for why it has not already undertaken the expansive investigation it now proposes, and Ford's past efforts to evaluate the safety of the covered inflators do not support granting a deferral. NHTSA requested Ford's assistance in evaluating Takata calcium-
It is difficult to reconcile Ford's ambitious plan with its prior approach toward evaluating the safety of the covered inflators. Ford has provided no compelling argument for the Agency to deviate from 49 CFR 556.4(b)(5).
For these reasons, NHTSA denies Mazda's request for a deferral of NHTSA's decision on Mazda's Petition. The Agency will decide on Mazda's Petition without consideration of Ford's planned additional efforts. Nevertheless, NHTSA recognizes Ford's plans to further evaluate the safety of Takata calcium-sulfate desiccated PSDI-5 driver-side airbag inflators, and encourages Ford to move forward with those plans as described—particularly given the concern about these inflators that Ford has expressed.
Accordingly, NHTSA hereby gives notice of its receipt of Mazda Motor Corporation Petition for a Determination of Inconsequentiality of Takata's Defect Information Report filing under NHTSA Campaign Number 17E-034 for PSDI-5 Desiccated Driver Air Bag Inflators. And it is hereby
1. The period for public comment on Mazda's Petition shall run from the publication of this decision through December 18, 2017; and
2. Mazda's request for a deferral of NHTSA's decision on its Petition, so that Ford may complete its intensified and expanded inflator field study, aging assessment, and testing on additional samples, is
49 U.S.C. 30101,
National Highway Traffic Safety Administration (NHTSA), Department of Transportation.
Notice of receipt of petition; notice of receipt of request for deferral, and of decision denying request for deferral.
On July 10, 2017, Takata Corporation (“Takata”) filed a defect information report (“DIR”) in which it determined that a safety-related defect exists in certain phase-stabilized ammonium nitrate (“PSAN”) driver-side airbag inflators that it manufactured with a calcium sulfate desiccant, including inflators that it supplied to Ford Motor Company (“Ford”), Mazda North American Operations (“Mazda”), and Nissan North America Inc. (“Nissan”) for use in certain vehicles. Ford has petitioned the Agency for a decision that, because analysis of inflators installed in certain Ford vehicles does not demonstrate propellant-tablet density degradation or increased inflation pressure, and because there are design differences between the inflators installed in Ford vehicles and an inflator variant installed in Nissan vehicles, the equipment defect determined to exist by Takata is inconsequential as it relates to motor vehicle safety in the Ford vehicles affected by Takata's DIR. Ford requests relief from its notification and remedy obligations under the National Traffic and Motor Vehicle Safety Act of 1966 and its applicable regulations, and further requests that the Agency allow Ford until March 31, 2018 to complete certain analysis and testing before the Agency decides on the petition.
The closing date for comments is December 18, 2017.
Interested persons are invited to submit written data, views, and arguments regarding this petition for inconsequentiality. Comments must refer to the docket and notice number cited in the title of this notice and be submitted by one of the following methods:
•
•
•
•
You may call the Docket at (202) 366-9324.
Note that all comments received will be posted without change to
The petition, supporting materials, and all comments received before the close of business on the closing date indicated above will be filed in the docket and will be considered. Comments and supporting materials received after the closing date will also be filed and will be considered to the extent possible. When the petition is granted or denied, notice of the decision will also be published in the
For legal issues: Stephen Hench, Office of the Chief Counsel, NCC-100, National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590 (telephone: (202) 366-5263).
For general information regarding NHTSA's investigation into Takata airbag inflator ruptures and the related recalls, visit
On November 3, 2015, NHTSA issued, and Takata agreed to, a Consent Order setting forth penalties, requirements, and performance obligations in connection with Takata's alleged failure to fully comply with the National Traffic and Motor Vehicle Safety Act of 1966 as amended and recodified (the “Safety Act”), 49 U.S.C. 30101,
In February 2016, NHTSA requested Ford's assistance in evaluating Takata calcium-sulfate desiccated PSDI-5 driver-side airbag inflators, to which Ford agreed. In June 2016, Ford and Takata began a field-recovery program to evaluate Takata calcium-sulfate desiccated PSDI-5 driver-side airbag inflators that were original equipment in MY 2007-2008 Ford Ranger vehicles in Florida, Michigan, and Arizona.
Takata has analyzed over 400 such inflators from the Ford program—as well as 895 such inflators from the Nissan program.
Takata's DIR filing triggered Ford's obligation to file a DIR for its affected vehicles.
Ford's Petition involves approximately 3.04 million light vehicles that contain the covered Ford inflators. These vehicles are:
Ford argues that Takata's DIR does not determine the covered Ford inflators “actually contain a defect at this time, or that they will develop one over time,” and that once Ford completes its engineering analysis (by the end of March 2018), it will be able to supplement or amend its Petition to “allow the Agency to make a determination” on its Petition.
Ford's position that the defect is inconsequential rests on two related arguments. First, in contrast to testing data pertaining to the covered Nissan inflators, Ford contends Takata's analysis of the covered Ford inflators does not show propellant-tablet density degradation or increased inflation pressure.
Second, and relatedly, Ford contends “[t]here are design differences” in the covered Ford inflators when compared to the covered Nissan inflators, and that such differences may explain differences observed between the two inflator variants during testing.
The remainder of Ford's Petition explains its “commit[ment] to further investigation of PSDI-5 airbag inflators.”
Ford has requested that NHTSA allow it additional time before deciding on its Petition—specifically, until March 31, 2018—so that it may “complete its intensified and expanded inflator field study, aging assessment, and testing on additional samples and vehicle types to evaluate the performance of the Takata desiccated PSDI-5 driver airbag inflators.”
The Agency recognizes Ford's plans to expand its investigation and to secure a supply of remedy inflators for affected vehicles if it becomes needed.
Specifically, NHTSA does not find Ford's request for deferral reasonable under the circumstances or supported by the testing and data it has collected to date. Indeed, Ford does not provide an explanation for why it has not already undertaken the expansive investigation it now proposes, and Ford's past efforts to evaluate the safety of the covered inflators do not support granting a deferral. NHTSA requested Ford's assistance in evaluating Takata calcium-sulfate desiccated PSDI-5 driver-side airbag inflators in February 2016, and over seventeen months later only about 400 covered Ford inflators have been tested. Further, while the covered Ford inflators were original equipment in six vehicle models (Ranger, Fusion, MKZ, Milan, Edge, and MKX), all approximately 400 inflators harvested in Ford's field-recovery program were from the same vehicle model (the Ranger). Moreover, the number of inflators tested under Ford's program was less than half the number tested under Nissan's program, and about
It is difficult to reconcile Ford's ambitious plan with its prior approach toward evaluating the safety of the covered inflators. Ford has provided no compelling argument for the Agency to deviate from 49 CFR 556.4(b)(5).
For these reasons, NHTSA denies Ford's request for a deferral of the NHTSA's decision on Ford's Petition. The Agency will decide on Ford's Petition without consideration of Ford's planned additional efforts as outlined in its Petition. Nevertheless, NHTSA recognizes Ford's plans to further evaluate the safety of Takata calcium-sulfate desiccated PSDI-5 driver-side airbag inflators, and encourages Ford to move forward with those plans as described in its Petition—particularly given the concern about these inflators that Ford has expressed.
Accordingly, NHTSA hereby gives notice of its receipt of Ford's Petition for a Determination of Inconsequentiality and Request for Deferral of Determination Regarding Certain Ford Vehicles Equipped with Takata PSDI-5 Desiccated Driver Airbag Inflators. And it is hereby
1. The period for public comment on Ford's Petition shall run from the publication of this decision through December 18, 2017; and
2. Ford's request for a deferral of NHTSA's decision on Ford's Petition, so that Ford may complete its intensified and expanded inflator field study, aging assessment, and testing on additional samples and vehicle types, is
49 U.S.C. 30101,
Office of the Secretary, Department of Transportation (DOT).
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, as amended, this notice announces the Department of Transportation's (Department) intention to reinstate an Office of Management and Budget (OMB) control number for the collection and posting of certain aviation
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Comments on this notice must be received by December 18, 2017. Interested persons are invited to submit comments regarding this proposal.
Send comments regarding the burden estimate, including suggestions for reducing the burden, to the Office of Management and Budget, Attention: Desk Officer for the Office of the Secretary of Transportation, 725 17th Street NW., Washington, DC 20503. Comments may also be sent via email to OMB at the following address:
To ensure that you do not duplicate your docket submissions, please submit them by only one of the following means:
•
•
•
Daeleen Chesley, Office of the Secretary, Office of the Assistant General Counsel for Aviation Enforcement and Proceedings (C-70), Department of Transportation, 1200 New Jersey Ave. SE., Washington, DC 20590, 202-366-9342 (voice) 202-366-7152 (fax) or
On April 25, 2011, the Department issued a rule to enhance airline passenger protections that, among other things, extended to foreign carriers the requirement to post tarmac delay plans, customer service plans, and contracts of carriage on their Web sites. This requirement had previously only applied to U.S. carriers. Airlines are also required to adopt a Customer Service Plan, audit adherence to the plan annually, and retain the results for two years. In addition, a prior rule issued on December 30, 2009, required that each reporting air carrier (
The Paperwork Reduction Act of 1995 (PRA) and its implementing regulations, 5 CFR part 1320, require Federal agencies to issue two notices seeking public comment on information collection activities before OMB may approve paperwork packages. 44 U.S.C. 3506, 3507; 5 CFR 1320.5, 1320.8(d)(1), 1320.12. On May 22, 2017, OST published a 60-day notice in the
Before OMB decides whether to approve these proposed collections of information, it must provide 30 days for public comment. 44 U.S.C. 3507(b); 5 CFR 1320.12(d). Federal law requires OMB to approve or disapprove paperwork packages between 30 and 60 days after the 30-day notice is published. 44 U.S.C. 3507(b)-(c); 5 CFR 1320.12(d);
This notice addresses five information collection requirements concerning information collection requirements set forth in the Department's airline passenger protection rules. The reinstated OMB control number will be applicable to all information collection systems set forth in this notice. For each of these information collections, the title, a description of the respondents, and an estimate of the annual recordkeeping and periodic reporting burden (rounded to the nearest hour) are set forth below:
1. Requirement to post customer service plans and contracts of carriage on a carrier's Web site. (259.2 and 259.6).
2. Requirement to retain for two years information about any tarmac delay that lasts at least three hours. (259.2 and 259.4).
3. Requirement that certain U.S. and foreign air carriers retain for two years the results of its annual self-audit of its compliance with its Customer Service Plan. (259.2 and 259.5)
4. Requires that each large U.S. carrier display on its Web site, at a point before the consumer selects a flight for purchase, the following information for each listed flight regarding its on-time performance during the last reported month: The percentage of arrivals that were on time (within 15 minutes of scheduled arrival time), the percentage of arrivals that were more than 30 minutes late (with special highlighting if the flight was more than 30 minutes late more than 50 percent of the time), and the percentage of flight cancellations if the flight is cancelled more than 5% of the time. In addition, a marketing/reporting carrier display delay data for its non-reporting code-share carrier(s). (234.11)
5. Requirement that certain carriers report tarmac delay data for tarmac delays exceeding 3 hours to the Department monthly. (244.2)
We invite comments on (a) whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; (b) the accuracy of the Department's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology. All comments will also become a matter of public record on the docket.
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act that the Veterans and Community Oversight and Engagement Board (Board) will meet on December 5-7, 2017, at 11301 Wilshire Boulevard, Building 500, Room 1281, Los Angeles, CA, from 9:00 a.m. until 4:00 p.m. (Pacific). Sessions are open to the public, except when the Committee is conducting tours of VA facilities, participating in off-site events, and participating in workgroup sessions. Tours of VA facilities are closed, to protect Veterans' privacy and personal information.
The Board is a statutory board established by the West Los Angeles Leasing Act of 2016 on September 29, 2016. The purpose of the Board is to provide advice and make recommendations to the Secretary of Veterans Affairs on: Identifying the goals of the community and Veteran partnership; improving services and outcomes for Veterans, members of the Armed Forces, and the families of such Veterans and members; and on the implementation of the Draft Master Plan approved by the Secretary on January 28, 2016, and on the creation and implementation of any successor master plans.
On Tuesday, December 5, the Board will convene an open session from 9:00 a.m. to 4:00 p.m. The agenda will include briefings from officials at the VA and other VA entities to include: Training on Federal advisory committees and Ethics; guidance to the Board members on their roles and responsibilities. The Board will be broken into small groups to participate in a facilitated working-group activity for the balance of the day, and report out to the full committee to complete the day.
On Wednesday, December 6, the Board will convene an open session from 9:00 a.m. to 11:15 a.m. The agenda will include briefings on the West LA Leasing Act of 2016, and a detailed briefing on the Draft Master Plan (with updates). From 12:30 p.m. to 1:30 p.m., the Board will convene in a closed session as it tours the West LA Campus. The Board will reconvene an open session at 1:30 p.m. to 4:00 p.m. at which, the Board members will once again participate in Committee Facilitated discussions followed by additional facilitated subcommittee discussions. The day will conclude with any closing remarks and guidance from the Board Chair.
On Thursday, December 7, the Board will convene an open session from 9:00 a.m. to 12:00 p.m. and will begin with reports or comments from the subcommittee facilitated discussion, and discussion of topics and schedule for upcoming meetings. Additionally, time will be allocated for receiving public comments on December 7, at 9:45 a.m. Public comments shall be limited to five minutes each. Individuals wishing to make oral statements before the Board will be accommodated on a first come first serve basis. Individuals who speak are invited to submit a 1-2 page summary of their comments at the time of the meeting for inclusion in the official record. The Board will accept written comments from interested parties on issues outlined in the meeting agenda, as well as other issues affecting identifying the goals of the community and Veteran partnership; improving services and outcomes for Veterans, members of the Armed Forces, and the families of such Veterans and members; and on the implementation of the Draft Master Plan. Such comments should be sent to Eugene W. Skinner, Jr., Designated Federal Officer, Veterans Experience Office via email to
Any member of the public seeking additional information should contact Mr. Skinner, via email at
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule with comment period and interim final rule with comment period.
The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) established the Quality Payment Program for eligible clinicians. Under the Quality Payment Program, eligible clinicians can participate via one of two tracks: Advanced Alternative Payment Models (APMs); or the Merit-based Incentive Payment System (MIPS). We began implementing the Quality Payment Program through rulemaking for calendar year (CY) 2017. This final rule with comment period provides updates for the second and future years of the Quality Payment Program.
In addition, we also are issuing an interim final rule with comment period (IFC) that addresses extreme and uncontrollable circumstances MIPS eligible clinicians may face as a result of widespread catastrophic events affecting a region or locale in CY 2017, such as Hurricanes Irma, Harvey and Maria.
In commenting, please refer to file code CMS-5522-FC when commenting on issues in the final rule with comment period, and CMS-5522-IFC when commenting on issues in the interim final rule with comment period. 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.
Benjamin Chin, (410) 786-0679, for inquiries related to APMs.
Because of the many terms to which we refer by acronym in this rule, we are listing the acronyms used and their corresponding meanings in alphabetical order below:
This final rule with comment period makes payment and policy changes to the Quality Payment Program. 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 (SGR) formula, to reauthorize the Children's Health Insurance Program (CHIP), and to strengthen Medicare access by improving physician and other clinician payments and making other improvements. The MACRA advances a forward-looking, coordinated framework for clinicians to successfully take part in the 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).
Our goal is to support patients and clinicians in making their own decisions about health care using data driven insights, increasingly aligned and meaningful quality measures, and innovative technology. To implement this vision, the Quality Payment Program emphasizes high-value care and patient outcomes while minimizing burden on eligible clinicians. The Quality Payment Program is also designed to be flexible, transparent, and structured to improve over time with input from clinicians, patients, and other stakeholders.
In today's health care system, we often pay doctors and other clinicians based on the number of services they perform rather than patient health outcomes. The good work that clinicians do is not limited to conducting tests or writing prescriptions, but also taking the time to have a conversation with a patient about test results, being available to a patient through telehealth or expanded hours, coordinating medicine and treatments to avoid confusion or errors, and developing care plans.
The Quality Payment Program takes a comprehensive approach to payment by basing consideration of quality on a set of evidenced-based measures that were primarily developed by clinicians, thus encouraging improvement in clinical practice and supporting by advances in technology that allow for the easy exchange of information. The Quality Payment Program also offers special incentives for those participating in certain innovative models of care that
We have sought and will continue to seek feedback from the health care community through various public avenues such as rulemaking, listening sessions and stakeholder engagement. We understand that technology, infrastructure, physician support systems, and clinical practices will change over the next few years and are committed to refine our policies for the Quality Payment Program with those factors in mind.
We are aware of the diversity among clinician practices in their experience with quality-based payments and expect the Quality Payment Program to evolve over multiple years. The groundwork has been laid for expansion toward an innovative, patient-centered, health system that is both outcome focused and resource effective. A system that leverages health information technology to support clinicians and patients and builds collaboration across care settings. The Quality Payment Program: (1) Supports care improvement by focusing on better outcomes for patients, and preserving the independent clinical practice; (2) promotes the adoption of APMs that align incentives for high-quality, low-cost care across healthcare stakeholders; and (3) advances existing delivery system reform efforts, including ensuring a smooth transition to a healthcare system that promotes high-value, efficient care through unification of CMS legacy programs.
In the Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models final rule with comment period (81 FR 77008, November 4, 2016), referred to as the “CY 2017 Quality Payment Program final rule,” we established incentives for participation in Advanced APMs, supporting the goals of transitioning from fee-for-service (FFS) payments to payments for quality and value. The CY 2017 Quality Payment Program final rule included definitions and processes to determine Qualifying APM Participants (QPs) in Advanced APMs. The CY 2017 Quality Payment Program final rule also established the criteria for use by the Physician-Focused Payment Model Technical Advisory Committee (PTAC) in making comments and recommendations to the Secretary on proposals for physician-focused payment models (PFPMs).
The CY 2017 Quality Payment Program final rule also established policies to implement MIPS, which consolidated certain aspects of 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 made CY 2017 the transition year for clinicians under the Quality Payment Program. As prescribed by MACRA, MIPS focuses on the following: (1) Quality—including a set of evidence-based, specialty-specific standards; (2) cost; (3) practice-based improvement activities; and (4) use of certified electronic health record (EHR) technology (CEHRT) to support interoperability and advanced quality objectives in a single, cohesive program that avoids redundancies.
This CY 2018 final rule with comment period continues to build and improve upon our transition year policies, as well as, address elements of MACRA that were not included in the first year of the program, including virtual groups, beginning with the CY 2019 performance period facility-based measurement, and improvement scoring. This final rule with comment period implements policies for “Quality Payment Program Year 2,” some of which will continue into subsequent years of the Quality Payment Program.
We have also included an interim final rule with comment period to establish an automatic extreme and uncontrollable circumstance policy for the 2017 MIPS performance period that recognizes recent hurricanes (Harvey, Irma, and Maria) and other natural disasters can effectively impede a MIPS eligible clinician's ability to participate in MIPS.
After extensive outreach with clinicians, patients and other stakeholders, we created 7 strategic objectives to drive continued progress and improvement. These objectives help guide our final policies and future rulemaking in order to design, implement, and advance a Quality Payment Program that aims to improve health outcomes, promote efficiency, 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 on program performance to provide accurate, timely, and actionable feedback to clinicians and other stakeholders; (6) to deliver IT systems capabilities that meet the needs of users for data submission, reporting, and improvement and are seamless, efficient and valuable on the front and back-end; and (7) to ensure operation excellence in program implementation and ongoing development; and to design the program in a manner that allows smaller independent and rural practices to be successful. More information on these objectives and the Quality Payment Program can be found at
Stakeholder feedback is the hallmark of the Quality Payment Program. We solicited and reviewed nearly 1,300 comments and had over 100,000 physicians and other stakeholders attend our outreach sessions to help inform our policies for Quality Payment Program Year 2. We have set ambitious yet achievable goals for those clinicians interested in APMs, as they are a vital part of bending the Medicare cost curve by encouraging the delivery of high-quality, low-cost care. To allow this program to work 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 APMs if that is the best choice for their practice. Finally, we understand that we must achieve excellence in program management, focusing on customer needs while also 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 goal 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-value care to their patients in a streamlined and cost-effective manner. Within MIPS, the second pathway of the Quality Payment Program, we believe that integration into typical clinical
Although there are two separate pathways within the Quality Payment Program, Advanced APMs and MIPS both contribute toward the goal of seamless integration of the Quality Payment Program into clinical practice workflows. Advanced APMs promote this seamless integration by way of payment methodology and design that incentivize care coordination. The MIPS builds the capacity of eligible clinicians across the four pillars of MIPS to prepare them for participation in APMs in later years of the Quality Payment Program. Indeed, the bedrock of the Quality Payment Program is high-value, patient-centered care, informed by useful feedback, in a continuous cycle of improvement. The principal way that MIPS measures quality of care is through a set of clinical quality measures (CQMs) from which MIPS eligible clinicians can select. The CQMs are evidence-based, and the vast majority are created or supported by clinicians. Over time, the portfolio of quality measures will grow and develop, driving towards outcomes that are of the greatest importance to patients and clinicians and away from process, or “check the box” type measures.
Through MIPS, we have the opportunity to measure clinical and patient outcomes, not only through evidence-based quality measures, but also by accounting for activities that clinicians and patients themselves identify: Namely, practice-driven quality improvement. MIPS also requires us to assess whether CEHRT is used in a meaningful way and based on significant feedback, this area was simplified to support the exchange of patient information, engagement of patients in their own care through technology, and the way technology specifically supports the quality goals selected by the practice. And lastly, MIPS requires us to measure the cost of services provided through the cost performance category, which will contribute to a MIPS eligible clinician's final score beginning in the second year of the MIPS.
We realize the Quality Payment Program is a big change. In this final rule with comment period, we continue the slow ramp-up of the Quality Payment Program by establishing special policies for MIPS Year 2 aimed at encouraging successful participation in the program while reducing burden, reducing the number of clinicians required to participate, and preparing clinicians for the CY 2019 performance period (CY 2021 payment year). 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 believe the second year of the Quality Payment Program should build upon the foundation that has been established which provides a trajectory for clinicians to value-based care. A second year to ramp-up the program will continue to help build upon the iterative learning and development of year 1 in preparation for a robust program in year 3.
The support of small, independent practices remains an important thematic objective for the implementation of the Quality Payment Program and is expected to be carried throughout future rulemaking. Many small practices did not have to participate in MIPS during the transition year due to the low-volume threshold, which was set for the CY 2017 performance period at less than or equal to $30,000 in Medicare Part B allowed charges or less than or equal to 100 Medicare Part B patients. We have heard feedback that many small practices still face challenges in their ability to participate in the program. We are implementing additional flexibilities for Year 2 including: Implementing the virtual groups provisions; increasing the low-volume threshold to less than or equal to $90,000 in Medicare Part B allowed charges or less than or equal to 200 Medicare Part B patients; adding a significant hardship exception from the advancing care information performance category for MIPS eligible clinicians in small practices; providing 3 points even if small practices submit quality measures below data completeness standards; and providing bonus points that are added to the final scores of MIPS eligible clinicians who are in small practices. We believe that these additional flexibilities and reduction in barriers will further enhance the ability of small practices to participate successfully in the Quality Payment Program.
In keeping with the objectives to provide education about the Quality Payment Program and maximize participation, and as mandated by the statute, during a period of 5 years, $100 million in funding was provided for technical assistance to be available to provide guidance and assistance to MIPS eligible clinicians in small practices through contracts with regional health collaboratives, and others. Guidance and assistance on the MIPS performance categories or the transition to APM participation will be available to MIPS eligible clinicians in practices of 15 or fewer clinicians with priority given to practices located in rural areas or medically underserved areas (MUAs), and practices with low MIPS final scores. More information on the technical assistance support available to small practices can be found at
We have also performed an updated regulatory impact analysis, accounting for flexibilities, many of which are continuing into the Quality Payment Program Year 2, that have been created to ease the burden for small and solo practices.
APMs represent an important step forward in our efforts to move our healthcare system from volume-based to value-based care. Our existing APM policies provide opportunities that support state flexibility, local leadership, regulatory relief, and innovative approaches to improve quality, accessibility, and affordability.
APMs that meet the criteria to be Advanced APMs provide the pathway through which eligible clinicians, many of whom who would otherwise fall under the MIPS, can become Qualifying APM Participants (QPs), thereby earning incentives for their Advanced APM participation. In the CY 2017 Quality Payment Program final rule, we estimated that 70,000 to 120,000 eligible clinicians would be QPs for payment year 2019 based on Advanced APM participation in performance year 2017 (81 FR 77516). With new Advanced APMs expected to be available for participation in 2018, including the Medicare ACO Track 1 Plus (1+) Model, and the addition of new participants for some current Advanced APMs, such as the Next Generation ACO Model and Comprehensive Primary Care Plus (CPC+) Model, we anticipate higher numbers of QPs in subsequent years of the program. We currently estimate that approximately 185,000 to 250,000
In the CY 2017 Quality Payment Program final rule, to be considered an Advanced APM, we finalized that 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 (81 FR 77408).
We are maintaining the generally applicable revenue-based nominal amount standard at 8 percent for QP Performance Periods 2019 and 2020. We are exempting participants in Round 1 of the CPC+ Model as of January 1, 2017 from the 50 eligible clinician limit as proposed. We are also finalizing a more gradual ramp-up in percentages of revenue for the Medical Home Model nominal amount standard over the next several years.
QPs are eligible clinicians in an Advanced APM who have met a threshold percentage of their patients or payments through an Advanced APM or, beginning in performance year 2019, attain QP status through the All-Payer Combination Option. Eligible clinicians who are QPs for a year are excluded from the MIPS reporting requirements and payment adjustment for the year, and receive a 5 percent APM Incentive Payment for the year in years from 2019 through 2024. The statute sets thresholds for the level of participation in Advanced APMs required for an eligible clinician to become a QP for a year.
We are finalizing that for Advanced APMs that start or end during the QP Performance Period and operate continuously for a minimum of 60 days during the QP Performance Period for the year, we are making QP determinations using payment or patient data only for the dates that APM Entities were able to participate in the Advanced APM per the terms of the Advanced APM, not for the full QP Performance Period.
Eligible clinicians who participate in Advanced APMs but do not meet the QP or Partial QP thresholds are subject to MIPS reporting requirements and payment adjustments unless they are otherwise excluded from MIPS.
The All-Payer Combination Option, which uses a calculation based on an eligible clinician's participation in both Advanced APMs and Other Payer Advanced APMs to make QP determinations, is applicable beginning in performance year 2019. To become a QP through the All-Payer Combination Option, an eligible clinician must participate in an Advanced APM with CMS as well as an Other Payer Advanced APM. We determine whether other payer arrangements are Other Payer Advanced APMs based on information submitted to us by eligible clinicians, APM Entities, and in some cases by payers, including states and Medicare Advantage Organizations. In addition, the eligible clinician or the APM Entity must submit information to CMS so that we can determine whether the eligible clinician meets the requisite QP threshold of participation.
To be an Other Payer Advanced APM, as set forth in section 1833(z)(2)(B)(ii) and (C)(ii) of the Act and implemented in the CY 2017 Quality Payment Program final rule, a payment arrangement with a payer (for example, payment arrangements authorized under Title XIX, Medicare Health Plan payment arrangements, and payment arrangements in CMS Multi-Payer Models) must meet all three of the following criteria: (1) CEHRT is used; (2) the payment arrangement must require the use of quality measures comparable to those in the quality performance category under MIPS; and (3) the payment arrangement must either require the APM Entities to 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.
In this final rule with comment period, we are finalizing policies that provide more detail about how the All-Payer Combination Option will operate. We are finalizing that an other payer arrangement would meet the generally applicable revenue-based nominal amount standard we proposed if, under the terms of the other payer arrangement, the total amount that an APM Entity potentially owes the payer or foregoes is equal to at least: For the 2019 and 2020 QP Performance Periods, 8 percent of the total combined revenues from the payer of providers and suppliers in participating APM Entities only for arrangements that are expressly defined in terms of revenue. We are also finalizing a more gradual ramp-up in percentages of revenue for the Medicaid Medical Home Model nominal amount standard over the next several years.
We are finalizing the Payer Initiated and Eligible Clinician Other Payer Advanced APM determination processes to allow payers, APM Entities, or eligible clinicians to request that we determine whether other payer arrangements meet the Other Payer Advanced APM criteria. We have also finalized requirements pertaining to the submission of information.
We are finalizing certain modifications to how we calculate Threshold Scores and make QP determinations under the All-Payer Combination Option. We are retaining the QP Performance Period for the All-Payer Combination Option from January 1 through August 31 of each year as finalized in the CY 2017 Quality Payment Program final rule.
The PTAC is an 11-member federal advisory committee that is an important avenue for the creation of innovative payment models. The PTAC is charged with reviewing stakeholders' proposed PFPMs, and making comments and recommendations to the Secretary regarding whether they meet the PFPM criteria established by the Secretary through rulemaking in the CY 2017 Quality Payment Program final rule. The Secretary is required to review the comments and recommendations submitted by the PTAC and post a detailed response to these recommendations on the CMS Web site.
We sought comments on broadening the definition of PFPM to include payment arrangements that involve Medicaid or the Children's Health Insurance Program (CHIP) as a payer even if Medicare is not included as a payer. We are maintaining the current definition of a PFPM to include only payment arrangements with Medicare as a payer. We believe this definition retains focus on APMs and Advanced APMs, which would be proposals that the Secretary has more direct authority to implement, while maintaining consistency for PTAC's review while they are still refining their processes. In addition, we sought comment on the Secretary's criteria and stakeholders' needs in developing PFPM proposals aimed at meeting the criteria.
For Quality Payment Program Year 2, which is the second year of the MIPS and includes the 2018 performance period and the 2020 MIPS payment year, as well as the following:
We previously finalized that the quality performance category would comprise 60 percent of the final score for the transition year and 50 percent of the final score for the 2020 MIPS payment year (81 FR 77100). While we proposed to maintain a 60 percent weight for the quality performance category for the 2020 MIPS payment year, we are not finalizing this proposal and will be keeping our previously finalized policy to weight the quality performance category at 50 percent for the 2020 MIPS payment year. We are also finalizing that for purposes of the 2021 MIPS payment year, the performance period for the quality and cost performance categories is CY 2019 (January 1, 2019 through December 31, 2019). We note that we had previously finalized that for the 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). We did not make proposals to modify this time frame in the CY 2018 Quality Payment Program proposed rule and are therefore unable to modify this performance period.
Quality measures are selected annually through a call for quality measures under consideration, with a final list of quality measures being published in the
For the 2018 MIPS performance period, we previously finalized that the data completeness threshold would increase to 60 percent for data submitted on quality measures using QCDRs, qualified registries, via EHR, or Medicare Part B claims. While we proposed to maintain a 50 percent data completeness threshold for the 2018 MIPS performance period, we are not finalizing this proposal and will be keeping our previously finalized data completeness threshold of 60 percent for data submitted on quality measures using QCDRs, qualified registries, EHR, or Medicare Part B claims for the 2018 MIPS performance period. We also proposed to have the data completeness threshold for the 2021 MIPS payment year (2019 performance period) to 60 percent for data submitted on quality measures using QCDRs, qualified registries, EHR, or Medicare Part B claims. We are also finalizing this proposal. We anticipate that as MIPS eligible clinicians gain experience with the MIPS we will propose to further increase these thresholds over time.
Improvement activities are those that improve clinical practice or care delivery and that, when effectively executed, are likely to result in improved outcomes. We believe improvement activities support broad aims within healthcare delivery, including care coordination, beneficiary engagement, population management, and health equity. For the 2020 MIPS payment year, we previously finalized that the improvement activities performance category would comprise 15 percent of the final score (81 FR 77179). There are no changes in improvement activities scoring for Quality Payment Program Year 2 (2018 MIPS performance period) as discussed in section II.C.7.a.(5) of this final rule with comment period. However, in this final rule, we are finalizing our proposal to no longer require self-identifications for non-patient facing MIPS eligible clinicians, small practices, practices located in rural areas or geographic HPSAs, or any combination thereof, beginning with the 2018 MIPS performance period and for future years.
We are finalizing that for Quality Payment Program Year 2 and future years (2018 MIPS performance period and future years), MIPS eligible clinicians or groups must submit data on improvement activities in one of the following manners: Via qualified registries, EHR submission mechanisms, QCDR, CMS Web Interface, or attestation; and that for activities that are performed for at least a continuous 90 days during the performance period, MIPS eligible clinicians must submit a yes response for activities within the Improvement Activities Inventory.
In this final rule with comment period, we are finalizing updates to the Improvement Activities Inventory. Specifically, as discussed in the appendices (Tables F and G) of this final rule with comment period, we are finalizing 21 new improvement activities (some with modification) and changes to 27 previously adopted improvement activities (some with modification and including 1 removal) for the Quality Payment Program Year 2 and future years (2018 MIPS performance period and future years) Improvement Activities Inventory. These activities were recommended by clinicians, patients and other stakeholders interested in advancing quality improvement and innovations in healthcare. We will continue to seek new improvement activities as the program evolves. Additionally, we are finalizing several policies related to submission of improvement activities. In particular, we are formalizing the annual call for activities process for Quality Payment Program Year 3 and future years. We are finalizing with modification, for the Quality Payment Program Year 3 and future years, that stakeholders should apply one or more of the criteria when submitting improvement activities in response to the Annual Call for Activities. In addition to the criteria listed in the proposed rule for nominating new improvement activities for the Annual Call for Activities policy, we are modifying and expanding the proposed criteria list to also include: (1) Improvement activities that focus on meaningful actions from the person and family's point of view, and (2) improvement activities that support the patient's family or personal caregiver. In addition, we are finalizing to: (1) Accept submissions for prospective improvement activities at any time during the performance period for the Annual Call for Activities and create an Improvement Activities Under Review (IAUR) list; (2) only consider prospective activities submitted by March 1 for inclusion in the Improvement Activities Inventory for the performance periods occurring in the following calendar year; and (3) add new improvement activities and subcategories through notice-and-comment rulemaking in future years of the Quality Payment Program.
Additionally, we are finalizing that for purposes of the 2021 MIPS payment year, the performance period for the improvement activities performance category is a minimum of a continuous 90-day period within CY 2019, up to and including the full CY 2019 (January 1, 2019 through December 31, 2019).
In this final rule with comment period, we are also expanding our
We are also finalizing changes to the study, including modifying the name to the “CMS Study on Burdens Associated with Reporting Quality Measures,” increasing the sample size for 2018, and updating requirements.
Furthermore, in recognition of improvement activities as supporting the central mission of a unified Quality Payment Program, we are finalizing in section II.C.6.e.(3)(a) of this final rule with comment period to continue to designate activities in the Improvement Activities Inventory that will also qualify for the advancing care information bonus score. This is consistent with our desire to recognize that CEHRT is often deployed to improve care in ways that our programs should recognize.
For the Quality Payment Program Year 2, the advancing care information performance category is 25 percent of the final score. However, if a MIPS eligible clinician is participating in a MIPS APM the advancing care information performance category may be 30 percent or 75 percent of the final score depending on the availability of APM quality data for reporting. We are finalizing that for purposes of the 2021 MIPS payment year, the performance period for advancing care information performance category is a minimum of a continuous 90-day period within CY 2019, up to and including the full CY 2019 (January 1, 2019 through December 31, 2019).
Objectives and measures in the advancing care information performance category focus on the secure exchange of health information and the use of CEHRT to support patient engagement and improved healthcare quality. While we continue to recommend that physicians and clinicians migrate to the implementation and use of EHR technology certified to the 2015 Edition so they may take advantage of improved functionalities, including care coordination and technical advancements such as application programming interfaces, or APIs, we recognize that some practices may have challenges in adopting new certified health IT. Therefore, we are finalizing that MIPS eligible clinicians may continue to use EHR technology certified to the 2014 Edition for the performance period in CY 2018. Clinicians may also choose to use the 2015 Edition CEHRT or a combination of the two. Clinicians will earn a bonus for using only 2015 CEHRT in 2018.
For the 2018 performance period, MIPS eligible clinicians will have the option to report the Advancing Care Information Transition Objectives and Measures using 2014 Edition CEHRT, 2015 Edition CEHRT, or a combination of 2014 and 2015 Edition CEHRT, as long as the EHR technology they possess can support the objectives and measures to which they plan to attest. Similarly, MIPS eligible clinicians will have the option to attest to the Advancing Care Information Objectives and Measures using 2015 Edition CEHRT or a combination of 2014 and 2015 Edition CEHRT, as long as their EHR technology can support the objectives and measures to which they plan to attest.
We are finalizing exclusions for the e-Prescribing and Health Information Exchange Objectives beginning with the 2017 performance period. We are also finalizing that eligible clinicians can earn 10 percentage points in their performance score for reporting to any single public health agency or clinical data registry to meet any of the measures associated with the Public Health and Clinical Data Registry Reporting objective (or any of the measures associated with the Public Health Reporting Objective of the 2018 Advancing Care Information Transition Objectives and Measures, for clinicians who choose to report on those measures) and, and will award an additional 5 percentage point bonus for reporting to more than one. We are implementing several provisions of the 21st Century Cures Act (Pub. L. 114-255, enacted on December 13, 2016) pertaining to hospital-based MIPS eligible clinicians, ambulatory surgical center-based MIPS eligible clinicians, MIPS eligible clinicians using decertified EHR technology, and significant hardship exceptions under the MIPS. We are also finalizing a significant hardship exception for MIPS eligible clinicians in small practices. For clinicians requesting a reweighting of the advancing care information performance category, we are changing the deadline for submission of this application to December 31 of the performance period. Lastly, we are finalizing additional improvement activities that are eligible for a 10 percent bonus under the advancing care information performance category if they are completed using CEHRT.
We previously finalized that the cost performance category would comprise zero percent of the final score for the transition year and 10 percent of the final score for the 2020 MIPS payment year (81 FR 77165). For the 2020 MIPS payment year, we proposed to change the weight of the cost performance category from 10 percent to zero percent (82 FR 30047). For the 2020 MIPS payment year, we are finalizing a 10 percent weight for the cost performance category in the final score in order to ease the transition to a 30 percent weight for the cost performance category in the 2021 MIPS payment year. For the 2018 MIPS performance period, we are adopting the total per capita costs for all attributed beneficiaries measure and the Medicare Spending per Beneficiary (MSPB) measure that were adopted for the 2017 MIPS performance period, and we will not use the 10 episode-based measures that were adopted for the 2017 MIPS performance period. Although data on the episode-based measures has been made available to clinicians in the past, we are in the process of developing new episode-based measures with significant clinician input and believe it would be more prudent to introduce these new measures over time. We will continue to offer performance feedback on episode-based measures prior to potential inclusion of these measures in MIPS to increase clinician familiarity with the concept as well as specific episode-based measures. Specifically, we are providing feedback on these new episode-based cost measures for informational purposes only. We intend to provide performance feedback on the MSPB and total per capita cost measures by July 1, 2018, consistent with section 1848(q)(12) of the Act. In addition, we intend to offer feedback on newly developed episode-based cost measures in 2018 as well.
We are finalizing additional flexibility for submitting data through multiple submission mechanisms. Due to operational reasons and to allow additional time to communicate how this policy intersects with our measure applicability policies, this policy will not be implemented for the 2018 performance period but will be implemented instead for the 2019 performance period of the Quality Payment Program. Individual MIPS eligible clinicians or groups will be able to submit measures and activities, as available and applicable, via as many mechanisms as necessary to meet the requirements of the quality, improvement activities, or advancing care information performance categories for the 2019 performance period. This option will provide clinicians the ability to select the measures most meaningful to them, regardless of the submission mechanism.
Also, given stakeholder concerns regarding CMS' multiple submissions mechanism policy, we want to clarify that under the validation process for Year 3, MIPS eligible clinicians who submit via claims or registry submission only or a combination of claims and registry submissions would not be required to submit measures through other mechanisms to meet the quality performance category criteria; rather, it is an option available to MIPS eligible clinicians which may increase their quality performance category score. We expect that MIPS eligible clinicians would choose the submission mechanism that would give them 6 measures to report. Our intention is to offer multiple submission mechanisms to increase flexibility for MIPS individual clinicians and groups. We are not requiring that MIPS individual clinicians and groups submit via additional submission mechanisms; however, through this policy the option would be available for those that have applicable measures and/or activities available to them.
Virtual groups are a new way to participate in MIPS starting with the 2018 MIPS performance period. For the 2018 performance period, clinicians can participate in MIPS as an individual, as a group, as an APM Entity in a MIPS APM, or as a virtual group.
For the implementation of virtual groups as a participation option under MIPS, we are establishing the following policies. We are defining a virtual group as a combination of two or more TINs assigned to one or more solo practitioners or one or more groups consisting of 10 or fewer eligible clinicians that elect to form a virtual group for a performance period for a year. In order for solo practitioners or such groups to be eligible to join a virtual group, the solo practitioners and the groups would need to exceed the low-volume threshold. A solo practitioner or a group that does not exceed the low-volume threshold could not participate in a virtual group, and it is not permissible under the statute to apply the low-volume threshold at the virtual group level. Also, we are finalizing our virtual group policies to clearly delineate those group-related policies that apply to virtual groups versus policies that only apply to virtual groups.
Virtual groups are required to make an election to participate in MIPS as a virtual group prior to the start of an applicable performance period. We are also finalizing a two-stage virtual group election process for the applicable 2018 and 2019 performance periods. The first stage is the optional eligibility stage, but for practices that do not choose to participate in stage 1 of the election process, we will make an eligibility determination during stage 2 of the election process. The second stage is the virtual group formation stage. We are also finalizing that virtual groups must have a formal written agreement among each party of a virtual group. The election deadline will be December 31.
To provide support and reduce burden, we intend to make technical assistance (TA) available, to the extent feasible and appropriate, to support clinicians who choose to come together as a virtual group for the first 2 years of virtual group implementation applicable to the 2018 and 2019 performance years. Clinicians already receiving technical assistance may continue to do so for virtual groups support; otherwise, the Quality Payment Service Center is available to assist and connect virtual groups with a technical assistance representative. For year 2, we believe that we have created an election process that is simple and straightforward. For Quality Payment Program Year 3, we intend to provide an electronic election process, if technically feasible.
Virtual groups are required to meet the requirements for each performance category and responsible for aggregating data for their measures and activities across the virtual group, for example, across their TINs. In future years, we intend to examine how we define “group” under MIPS with respect to flexibility in composition and reporting.
MIPS eligible clinicians who participate in MIPS APMs are scored using the APM scoring standard instead of the generally applicable MIPS scoring standard. For the 2018 performance period, we are finalizing modifications to the quality performance category reporting requirements and scoring for MIPS eligible clinicians in MIPS APMs, and other modifications to the APM scoring standard. For purposes of the APM scoring standard, we are adding a fourth snapshot date that would be used only to identify eligible clinicians in APM Entity groups participating in those MIPS APMs that require full TIN participation. This snapshot date will not be used to make QP determinations. Along with the other APM Entity groups, these APM Entity groups would be used for the purposes of reporting and scoring under the APM scoring standard described in the CY 2017 Quality Payment Program final rule (81 FR 77246).
We solicited comments on implementing facility-based measurement for the 2018 MIPS performance period and future performance periods to add more flexibility for clinicians to be assessed in the context of the facilities at which they work. We described facility-based measures policies related to applicable measures, applicability to facility-based measurement, group participation, and facility attribution. For clinicians whose primary professional responsibilities are in a healthcare facility we presented a method to assess performance in the quality and cost performance categories of MIPS based on the performance of that facility in another value-based purchasing program.
After much consideration, we are finalizing our proposal to allow clinicians to use facility-based measurement in year 3 (2019) of the Quality Payment Program. We will use the 2018 year to ensure that clinicians better understand the opportunity and ensure operational readiness to offer facility-based measurement.
In the transition year of the Quality Payment Program, we finalized a unified scoring system to determine a final score across the 4 performance categories (81 FR 77273 through 77276). For the 2018 MIPS performance period, we will build on the scoring methodology we finalized for the transition year, focusing on encouraging
For quality performance category scoring, we are finalizing to extend some of the transition year policies to the 2018 MIPS performance period and also finalizing several modifications to existing policy. Quality measures that can be scored against a benchmark that meet data completeness standards, and meet the minimum case size requirements will continue to receive between 3 and 10 points as measure achievement points. Measures that do not have a benchmark or meet the case minimum requirement will continue to receive 3 points.
For quality data submitted via EHR, QCDR, or qualified registry, we are lowering the number of points available for measures that do not meet the data completeness criteria to 1 point, except for a measure submitted by a small practice, which we will continue to assign 3 points.
We are finalizing a timeline to identify and propose to remove topped out quality measures through future rulemaking. We are evaluating additional considerations needed to maintain measures for important aspects of care, such as patient safety and high reliability, and will address this in future rulemaking. We are finalizing a policy of applying a scoring cap to identified topped out measures with measure benchmarks that have been topped out for at least 2 consecutive years; however, based on feedback, we will award up to 7 points for topped out measures rather than the 6 points originally proposed. We are finalizing the special scoring policy for the 6 measures identified for the 2018 performance period with a 7-point scoring cap.
We are also excluding CMS Web Interface measures from topped out scoring, but we will continue to monitor differences between CMS Web Interface and other submission options. We intend to address CAHPS through future rulemaking.
Beginning with the 2018 MIPS performance period, we are finalizing measuring improvement scoring at the performance category level for the quality performance category, but we will monitor this approach and revisit as needed through future rule making. We are finalizing measuring improvement scoring at the measure level for the cost performance category.
For the 2018 MIPS performance period, the quality, improvement activities, cost and advancing care information performance category scores will be given weight in the final score, or be reweighted if a performance category score is not available.
We are also finalizing small practice and complex patient bonuses only for the 2020 MIPS payment year. The small practice bonus of 5 points will be applied to the final score for MIPS eligible clinicians in groups, virtual groups, or APM Entities that have 15 or fewer clinicians and that submit data on at least one performance category in the 2018 performance period. We will also apply a complex patient bonus capped at 5 points using the dual eligibility ratio and average HCC risk score. We increased the complex patients bonus from 3 points as proposed in part to align with the small practice bonus. The final score will be compared against the MIPS performance threshold of 15 points for the 2020 MIPS payment year, a modest increase from 3 points in the transition year. A 15-point final score equal to the performance threshold can be achieved via multiple pathways and continues the gradual transition into MIPS. The additional performance threshold for exceptional performance will remain at 70 points, the same as for the transition year.
We are finalizing a policy of applying the MIPS payment adjustment to the Medicare paid amount.
We proposed and are finalizing the policy to provide Quality Payment Program performance feedback to eligible clinicians and groups. Initially, we will provide performance feedback on an annual basis. In future years, we aim to provide performance feedback on a more frequent basis, which is in line with clinician requests for timely, actionable feedback that they can use to improve care.
In the CY 2017 Quality Payment Program final rule (81 FR 77362), we finalized that qualified registries, QCDRs, health IT vendors, and CMS-approved survey vendors will have the ability to act as intermediaries on behalf of individual MIPS eligible clinicians and groups for submission of data to CMS across the quality, improvement activities, and advancing care information performance categories.
Regarding QCDRs and qualified registries, we are finalizing our proposal to eliminate the self-nomination submission method of email and require that QCDRs and qualified registries submit their self-nomination applications via a web-based tool for future program years beginning with the 2018 performance period. Beginning with the 2019 performance period, we are finalizing the use of a simplified self-nomination process for previously approved QCDRs and qualified registries in good standing.
In addition, regarding information a QCDR specifically must provide to us at the time of self-nomination, we are making a number of clarifications, finalized that the term “QCDR measures” will replace the existing term of “non-MIPS measures”, and sought public input on requiring full development and testing of QCDR measures by submission. We have also made a few clarifications to existing criteria as they pertain to qualified registries.
We are not making any changes to the health IT vendors that obtain data from CEHRT requirements. Regarding CMS-approved survey vendors, we are finalizing that for the Quality Payment Program year 2 and for future years, that the vendor application deadline be January 31st of the applicable performance year or a later date specified by CMS. Lastly, based on comments we received on the 10-year record retention period and our interest in reducing financial and time burdens under this program and having consistent policies across this program, we are aligning our record retention period across the program by modifying our proposal for third parties from 10 years to finalize a 6-year retention period. Therefore, we are finalizing that entities must retain all data submitted to us for purposes of MIPS for a 6 years from the end of the MIPS performance period.
As discussed in section II.C.11. of this final rule with comment period, we proposed and are finalizing public reporting of certain eligible clinician and group Quality Payment Program information, including MIPS and APM data in an easily understandable format as required under the MACRA.
We are modifying the definition of a non-patient facing MIPS eligible clinician to apply to virtual groups. In addition, we are finalizing our proposal to specify that groups considered to be non-patient facing (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 would automatically have their advancing care information performance category reweighted to zero.
Additionally, we are finalizing our proposal to increase the low-volume threshold to less than or equal to $90,000 in Medicare Part B allowed charges or 200 or fewer Part-B enrolled Medicare beneficiaries to further decrease burden on MIPS eligible clinicians that practice in rural areas or are part of a small practice or are solo practitioners. We are not finalizing our proposal to provide clinicians the ability to opt-in to MIPS if they meet or exceed one, but not all, of the low-volume threshold determinations, including as defined by dollar amount, beneficiary count or, if established, items and services. We intend to revisit this policy in future rulemaking and are seeking comment on methods to implement this policy in a low burden manner.
For the 2020 payment year based on Advanced APM participation in 2018 performance period, we estimated that approximately 185,000 to 250,000 clinicians will become QPs, and therefore, be excluded from the MIPS reporting requirements and payment adjustment, and qualify for a lump sum APM incentive payment equal to 5 percent of their estimated aggregate payment amounts for covered professional services in the preceding year. We estimate that the total lump sum APM incentive payments will be between approximately $675 million and $900 million for the 2020 Quality Payment Program payment year. This expected growth in QPs between the first and second year of the program is due in part to reopening of CPC+ and Next Generation ACO for 2018, and the Medicare ACO Track 1+ Model which is projected to have a large number of participants, with a large majority reaching QP status.
Under the policies in this final rule with comment period, and for purposes of the Regulatory Impact Analysis, we estimate that approximately 622,000 eligible clinicians will be subject to MIPS reporting requirements and payment adjustments in the 2018 MIPS performance period. However, this number may vary depending on the number of eligible clinicians excluded from MIPS based on their status as QPs or Partial QPs. After restricting the population to eligible clinician types who are not newly enrolled, we believe the increase in the low-volume threshold is expected to exclude 540,000 clinicians who do not exceed the low-volume threshold. In the 2020 MIPS payment year, MIPS payment adjustments will be applied based on MIPS eligible clinicians' performance on specified measures and activities within four integrated performance categories.
Assuming that 90 percent of MIPS eligible clinicians of all practice sizes participate in MIPS, we estimate that MIPS payment adjustments will be approximately equally distributed between negative MIPS payment adjustments of $118 million and positive MIPS payment adjustments of $118 million to MIPS eligible clinicians, as required by the statute to ensure budget neutrality. Positive MIPS payment adjustments will also include up to an additional $500 million for exceptional performance to MIPS eligible clinicians whose final score meets or exceeds the additional performance threshold of 70 points. 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 will change based on the final population of MIPS eligible clinicians for CY 2020 and the distribution of scores under the program. We believe that starting with these modest initial MIPS payment adjustments is in the long-term best interest of maximizing participation and starting the Quality Payment Program off on the right foot, even if it limits the magnitude of MIPS positive adjustments during the 2018 MIPS performance period. The increased availability of Advanced APM opportunities, including through Medical Home models, also provides earlier avenues to earn APM incentive payments for those eligible clinicians who choose to participate.
We quantify several costs associated with this rule. We estimate that this final rule with comment period will result in approximately $694 million in collection of information-related burden. We estimate that the incremental collection of information-related burden associated with this final rule with comment period is a reduction of approximately $13.9 million relative to the estimated burden of continuing the policies the CY 2017 Quality Payment Program final rule, which is $708 million. We also estimate regulatory review costs of $2.2 million for this final rule with comment period. We estimate that federal expenditures will include $118 million in revenue neutral payment adjustments and $500 million for exceptional performance payments. Additional federal expenditures include approximately $675-$900 million in APM incentive payments to QPs.
In order to account for Hurricanes Harvey, Irma, and Maria and other disasters that have occurred or might occur during the 2017 MIPS performance period, we are establishing in an interim final rule with comment period an automatic extreme and uncontrollable circumstance policy for the quality, improvement activities, and advancing care information performance categories for the 2017 MIPS performance period. We believe the automatic extreme and uncontrollable circumstance policy will reduce clinician burden during a catastrophic time and will also align with Medicare policies in other programs such as the Hospital IQR Program. Under this policy, we will apply the extreme and uncontrollable circumstance policies for the MIPS performance categories to individual MIPS eligible clinicians for the 2017 MIPS performance period without requiring a MIPS eligible clinician to submit an application when we determine a triggering event, such as a hurricane, has occurred and the clinician is in an affected area. We will automatically weight the quality, improvement activities, and advancing care information performance categories at zero percent of the final score, resulting in a final score equal to the performance threshold, unless the MIPS eligible clinician submits MIPS data which we would then score on a performance-category-by-performance-category-basis, like all other MIPS eligible clinicians. We are not making any changes to the APM scoring standard policies that apply in 2017 for participants in MIPS APMs. We are waiving notice and comment and adopting this policy on an interim final basis due to the urgency of providing relief for MIPS eligible clinicians impacted by recent natural disasters during the 2017 MIPS performance period.
In developing this final rule with comment period, we sought feedback from stakeholders and the public throughout the process, including in the CY 2018 Quality Payment Program proposed rule, CY 2017 Quality Payment Program final rule with comment period, listening sessions, webinars, and other listening venues. We received a high degree of interest
We thank stakeholders again for their responses throughout our process, in various venues, including comments on 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 (herein referred to as the MIPS and APMs RFI) (80 FR 59102 through 59113) and the CY 2017 Quality Payment Program final rule (81 FR 77008 through 77831). 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.
We will continue to offer help so clinicians can be successful in the program and make informed decisions about how to participate. You can find out more about the help that's available at
The following is a summary of the proposed provisions in the “Medicare Program; CY 2018 Updates to the Quality Payment Program” proposed rule (82 FR 30010-30500) (hereinafter referred to as the “CY 2018 Quality Payment Program proposed rule.” In this section, we also provide summaries of the public comments and our responses.
The Quality Payment Program, authorized by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) is a new approach for reforming care across the health care delivery system for eligible clinicians. Under the Quality Payment Program, eligible clinicians can participate via one of two pathways: Advanced Alternative Payment Models (APMs); or the Merit-based Incentive Payment System (MIPS). We began implementing the Quality Payment Program through rulemaking for calendar year (CY) 2017. This rule provides updates for the second and future years of the Quality Payment Program.
At § 414.1305, subpart O, we define the following terms:
We revise the definitions of the following terms:
We remove the following terms:
These terms and definitions are discussed in detail in relevant sections of this final rule with comment period.
In the CY 2017 Quality Payment Program final rule (81 FR77040 through 77041), we defined at § 414.1305 a MIPS eligible clinician, as identified by a unique billing TIN and NPI combination used to assess performance, as any of the following (excluding those identified at § 414.1310(b)): 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 clinicians. We established at § 414.1310(b) and (c) that the following are excluded from this definition per the statutory exclusions defined in section 1848(q)(1)(C)(ii) and (v) of the Act: (1) QPs; (2) Partial QPs who choose not to report on applicable measures and activities that are required to be reported under MIPS for any given performance period in a year; (3) low-volume threshold eligible clinicians; and (4) new Medicare-enrolled eligible clinicians. In accordance with sections 1848(q)(1)(A) and (q)(1)(C)(vi) of the Act, we established at § 414.1310(b)(2) that eligible clinicians (as defined at § 414.1305) who are not MIPS eligible clinicians have the option to voluntarily report measures and activities for MIPS. Additionally, we established at § 414.1310(d) that in no case will a MIPS payment adjustment apply to the items and services furnished during a year by eligible clinicians who are not MIPS eligible clinicians, as described in § 414.1310(b) and (c), including those who voluntarily report on applicable measures and activities specified under MIPS.
In the CY 2017 Quality Payment Program final rule (81 FR 77340), 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 payment adjustment at the TIN/NPI level. We have received requests for additional clarifications on which specific Part B services are subject to the MIPS payment adjustment, as well as which Part B services are included for eligibility determinations. We note that
To further clarify, there are circumstances that involve Part B prescription drugs and durable medical equipment (DME) where the supplier may also be a MIPS eligible clinician. In the case of a MIPS eligible clinician who furnishes a Part B covered item or service, such as prescribing Part B drugs that are dispensed, administered, and billed by a supplier that is a MIPS eligible clinician, or ordering DME that is administered and billed by a supplier that is a MIPS eligible clinician, it is not operationally feasible for us at this time to associate those billed allowed charges with a MIPS eligible clinician at an NPI level in order to include them for purposes of applying the MIPS payment adjustment or making eligibility determinations. To the extent that it is not operationally feasible for us to do so, such items or services would not be included for purposes of applying the MIPS payment adjustment or making eligibility determinations. However, for those billed Medicare Part B allowed charges that we are able to associate with a MIPS eligible clinician at an NPI level, such items and services would be included for purposes of applying the MIPS payment adjustment or making eligibility determinations.
As discussed in the CY 2017 Quality Payment Program final rule (81 FR 77088 through 77831), we indicated that we will assess performance either for individual MIPS eligible clinicians or for groups. We defined a group at § 414.1305 as a single Taxpayer Identification Number (TIN) with two or more eligible clinicians (including at least one MIPS eligible clinician), as identified by their individual NPI, who have reassigned their Medicare billing rights to the TIN. We recognize that MIPS eligible clinicians participating in MIPS may be part of a TIN that has one portion of its NPIs participating in MIPS according to the generally applicable scoring criteria while the remaining portion of its NPIs is participating in a MIPS APM or an Advanced APM according to the MIPS APM scoring standard. In the CY 2017 Quality Payment Program final rule (81 FR 77058), we noted that except for groups containing APM participants, we are not permitting groups to “split” TINs if they choose to participate in MIPS as a group. Thus, we would like to clarify that we consider a group to be either an entire single TIN or portion of a TIN that: (1) Is participating in MIPS according to the generally applicable scoring criteria while the remaining portion of the TIN is participating in a MIPS APM or an Advanced APM according to the MIPS APM scoring standard; and (2) chooses to participate in MIPS at the group level. We also defined an APM Entity group at § 414.1305 as a group of eligible clinicians participating in an APM Entity, as identified by a combination of the APM identifier, APM Entity identifier, TIN, and NPI for each participating eligible clinician.
In the CY 2017 Quality Payment Program final rule (81 FR 77188), we defined the term small practices at § 414.1305 as practices consisting of 15 or fewer clinicians and solo practitioners. However, it has come to our attention that there is inconsistency between the proposed definition of a solo practitioner discussed in section II.C.4.b. of this final rule with comment period and the established definition of a small practice. Therefore, to resolve this inconsistency and ensure greater consistency with established MIPS terminology, we are modifying the definition of a small practice at § 414.1305 to mean a practice consisting of 15 or fewer eligible clinicians. This modification is not intended to substantively change the definition of a small practice. In section II.C.4.d. of this final rule with comment period, we discuss how small practice status would apply to virtual groups. Also, in the final rule with comment period, we noted that we would not make an eligibility determination regarding the size of small practices, but indicated that small practices would attest to the size of their group practice (81 FR 77057). However, we have since realized that our system needs to account for small practice size in advance of a performance period for operational purposes relating to assessing and scoring the improvement activities performance category, determining hardship exceptions for small practices, calculating the small practice bonus for the final score, and identifying small practices eligible for technical assistance. As a result, we believe it is critical to modify the way in which small practice size would be determined. To make eligibility determinations regarding the size of small practices for performance periods occurring in 2018 and future years, we proposed that we would determine the size of small practices as described in this section of the final rule with comment period (82 FR 30020). As noted in the CY 2017 Quality Payment Program final rule, the size of a group (including a small practice) would be determined before exclusions are applied (81 FR 77057). We note that group size determinations are based on the number of NPIs associated with a TIN, which would include eligible clinicians (NPIs) who may be excluded from MIPS participation and do not meet the definition of a MIPS eligible clinician.
To make eligibility determinations regarding the size of small practices for performance periods occurring in 2018 and future years, we proposed that we would determine the size of small practices by utilizing claims data (82 FR 30020). For purposes of this section, we are coining the term “small practice size determination period” to mean a 12-month assessment period, which consists of an analysis of claims data that spans 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 includes a 30-day claims run out. This would allow us to inform small practices of their status near the beginning of the performance period as it pertains to eligibility relating to technical assistance, applicable improvement activities criteria, the proposed hardship exception for small practices under the advancing care information performance category, and the proposed small practice bonus for the final score.
Thus, for purposes of performance periods occurring in 2018 and the 2020 MIPS payment year, we would identify small practices based on 12 months of data starting from September 1, 2016 to August 31, 2017. We would not change an eligibility determination regarding the size of a small practice once the determination is made for a given performance period and MIPS payment year. We recognize that there may be circumstances in which the small practice size determinations made do not reflect the real-time size of such practices. We considered two options that could address such potential discrepancies. One option would include an expansion of the proposed small practice size determination period to 24 months with two 12-month segments of data analysis (before and during the performance period), in which we would conduct a second analysis of claims data during the performance period. Such an expanded
The following is a summary of the public comments received on the “Small Practices” proposal and our responses:
As discussed in the CY 2018 Quality Payment Program proposed rule (82 FR 30020), there are operational barriers with allowing groups to attest to their size. Specifically, since individual MIPS eligible clinicians and groups are not required to register to participate in MIPS (except for groups utilizing the CMS Web Interface for the Quality Payment Program or administering the CAHPS for MIPS survey), requiring small practices to attest to the size of their group practice prior to the performance period could increase burden on individual MIPS eligible clinicians and groups. In addition, attestation would require us to develop several operational improvements, such as a manual process or system that would provide an attestation mechanism for small practices, and a verification process to ensure that only small practices are identified as eligible for technical assistance. We believe utilizing claims data will support most eligibility determinations because we consider it a reliable source of how a MIPS eligible clinician or group interacts with Medicare.
In the CY 2017 Quality Payment Program final rule, we defined rural areas at § 414.1305 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; and Health Professional Shortage Areas (HPSAs) at § 414.1305 as areas designated under section 332(a)(1)(A) of the Public Health Service Act. For technical accuracy purposes, we proposed to remove the language “clinicians in” as clinicians are not technically part of a ZIP code and modify the definition of a rural areas at § 414.1305 as ZIP codes designated as rural, using the most recent Health Resources and Services Administration (HRSA) Area Health Resource File data set available.
We recognize that there are cases in which an individual MIPS eligible clinician (including a solo practitioner) or a group may have multiple practice sites associated with its TIN and as a result, it is critical for us to outline the application of rural area and HPSA practice designations to such practices. For performance periods occurring in 2017, we consider an individual MIPS eligible clinician or a group with at least one practice site under its TIN in a ZIP code designated as a rural area or HPSA to be a rural area or HPSA practice. For performance periods occurring in 2018 and future years, we believe that a higher threshold than one practice within a TIN is necessary to designate an individual MIPS eligible clinician, a group, or a virtual group as a rural or HPSA practice. We recognize that the establishment of a higher threshold starting in 2018 would more appropriately identify groups and virtual groups with multiple practices under a group's TIN or TINs that are part of a virtual group as rural or HPSA practice and ensure that groups and virtual groups are assessed and scored according to requirements that are applicable and appropriate. We note that in the CY 2017 Quality Payment Program final rule (81 FR 77048 through 77049), we defined a non-patient facing MIPS eligible clinician at § 414.1305 as including 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. We refer readers to section II.C.1.e. of this final rule with comment period for our policy to modify the definition of a non-patient facing MIPS eligible clinician. We believe that using a similar threshold for applying the rural and HPSA designation to an individual MIPS eligible clinician, a group, or virtual group with multiple practices under its TIN or TINs within a virtual group will add consistency for such practices across the MIPS as it pertains to groups and virtual groups obtaining such statuses. We also believe that establishing a 75 percent threshold renders an adequate representation of a group or virtual group where a significant portion of a group or a virtual group is identified as having such status. Therefore, for performance periods occurring in 2018 and future years, we proposed that an individual
The following is a summary of the public comments received on the “Rural Area and Health Professional Shortage Area Practices” proposals and our responses:
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
In the CY 2017 Quality Payment Program final rule (81 FR 77048 through 77049), we defined 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. In order to account for the formation of virtual groups starting in the 2018 performance year and how non-patient facing determinations would apply to virtual groups, we need to modify the definition of a non-patient facing MIPS eligible clinician. Therefore, for performance periods occurring in 2018 and future years, we proposed to modify the definition of a non-patient facing MIPS eligible clinician at § 414.1305 to mean 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 or virtual group provided that more than 75 percent of the NPIs billing under the group's TIN or within a virtual group, as applicable, meet the definition of a non-patient facing individual MIPS eligible clinician during the non-patient facing determination period (82 FR 30021).
We considered a patient-facing encounter to be an instance in which the individual MIPS eligible clinician or group billed for items and services furnished such as general office visits, outpatient visits, and procedure codes under the PFS. We published the list of patient-facing encounter codes for performance periods occurring in 2017 at
The list of patient-facing encounter codes includes two general categories of codes: Evaluation and Management (E&M) codes; and Surgical and Procedural codes. E&M codes capture clinician-patient encounters that occur in a variety of care settings, including office or other outpatient settings, hospital inpatient settings, emergency departments, and nursing facilities, in which clinicians utilize information provided by patients regarding history, present illness, and symptoms to determine the type of assessments to conduct. Assessments are conducted on the affected body area(s) or organ system(s) for clinicians to make medical decisions that establish a diagnosis or select a management option(s).
Surgical and Procedural codes capture clinician-patient encounters that involve procedures, surgeries, and other medical services conducted by clinicians to treat medical conditions. In the case of many of these services, evaluation and management work is included in the payment for the single code instead of separately reported. Patient-facing encounter codes from both of these categories describe direct services furnished by eligible clinicians with impact on patient safety, quality of care, and health outcomes.
For purposes of the non-patient facing policies under MIPS, the utilization of E&M codes and Surgical and Procedural codes allows for accurate identification of patient-facing encounters, and thus, accurate eligibility determinations regarding non-patient facing status. As a result, MIPS eligible clinicians considered non-patient facing are able to prepare to meet requirements applicable to non-patient facing MIPS eligible clinicians. We proposed to continue applying these policies for purposes of the 2020 MIPS payment year and future years (82 FR 30021).
As described in the CY 2017 Quality Payment Program final rule, we established the non-patient facing determination period for purposes of identifying non-patient facing MIPS eligible clinicians in advance of the performance period and during the performance period using historical and performance period claims data. This eligibility determination process allows us to begin identifying non-patient facing MIPS eligible clinicians prior to or shortly after the start of the performance period. The non-patient facing determination period is a 24-month assessment period, which includes a two-segment analysis of claims data regarding patient-facing encounters during an initial 12-month period prior to the performance period followed by another 12-month period during the performance period. The initial 12-month segment of the non-patient facing determination period spans 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 includes a 60-day claims run out, which allows us to inform individual 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 spans 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 includes a 60-day claims run out, which will allow us to inform additional individual MIPS eligible clinicians and groups of their non-patient status during the performance period.
However, based on our analysis of data from the initial segment of the non-patient facing determination period for performance periods occurring in 2017 (that is, data spanning from September 1, 2015 to August 31, 2016), we found that it may not be necessary to include a 60-day claims run out since we could achieve a similar outcome for such eligibility determinations by utilizing a 30-day claims run out. In our comparison of data analysis results utilizing a 60-day claims run out versus a 30-day claims run out, there was a 1 percent decrease in data completeness (see Table 1 for data completeness regarding comparative analysis of a 60-day and 30-day claims run out). The small decrease in data completeness would not negatively impact individual MIPS eligible clinicians or groups regarding non-patient facing determinations. We believe that a 30-day claims run out would allow us to complete the analysis and provide such determinations in a more timely manner.
For performance periods occurring in 2018 and future years, we proposed a modification to the non-patient facing determination period, in which 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 30-day claims run out; and 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 30-day claims run out (82 FR 30022). The proposal would only change the duration of the claims run out, not the 12-month timeframes used for the first and second segments of data analysis.
For purposes of the 2020 MIPS payment year, we would 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, 2016, to August 31, 2017. To account for the identification of additional individual MIPS eligible clinicians and groups that may qualify as non-patient facing during performance periods occurring in 2018, we would conduct another eligibility determination analysis based on 12 months of data starting from September 1, 2017, to August 31, 2018.
Similarly, for future years, we would 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 would 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 would continue to be considered non-patient facing for the duration of the performance period and MIPS payment year regardless of the results of the second eligibility determination analysis. We would 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.
Additionally, in the CY 2017 Quality Payment Program final rule (81 FR 77241), we established a policy regarding the re-weighting of the advancing care information performance category for non-patient facing MIPS eligible clinicians. Specifically, MIPS eligible clinicians who are considered to be non-patient facing will have their advancing care information performance category automatically reweighted to zero (81 FR 77241). For groups that are considered to be non-patient facing (that is, 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, we are finalizing in section II.C.7.b.(3) of this final rule with comment period to automatically reweight their advancing care information performance category to zero. We proposed to continue applying these policies for purposes of the 2020 MIPS payment year and future years.
The following is a summary of the public comments received on the “Non-Patient Facing MIPS Eligible Clinicians” proposals and our responses:
In the CY 2017 Quality Payment Program final rule (81 FR 77049), we noted that 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, but it would not apply to the facility payment to the CAH itself. For 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. As established in the CY 2017 Quality Payment Program final rule (81 FR 77051), the MIPS payment adjustment will apply to Method II CAH payments
We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77049 through 77051) for our discussion of MIPS eligible clinicians who practice in Method II CAHs.
As established in the CY 2017 Quality Payment Program final rule (81 FR 77051 through 77053), services furnished by an eligible clinician under the RHC or FQHC methodology, will not be subject to the MIPS payments adjustments. As noted, 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.
We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77051 through 77053) for our discussion of MIPS eligible clinicians who practice in RHCs or FQHCs.
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 ASC, HHA, Hospice, and/or HOPD and the facility bills for those items and services (including prescription drugs) under the facility's all-inclusive payment methodology or prospective payment system methodology, the MIPS adjustment would not apply to the facility payment itself. However, if a MIPS eligible clinician furnishes other items and services in an ASC, HHA, Hospice, and/or HOPD and bills for those items and services separately, such as under the PFS, the MIPS adjustment would apply to payments made for such items and services. Such items and services would also be considered for purposes of applying the low-volume threshold. Therefore, we proposed that services furnished by an eligible clinician that are payable under the ASC, HHA, Hospice, or HOPD methodology would not be subject to the MIPS payments adjustments (82 FR 30023). However, these eligible clinicians have the option to voluntarily report on applicable measures and activities for MIPS, in which case the data received would not be used to assess their performance for the purpose of the MIPS payment adjustment. We note that eligible clinicians who bill under both the PFS and one of these other billing methodologies (ASC, HHA, Hospice, and/or HOPD) may be required to participate in MIPS if they exceed the low-volume threshold and are otherwise eligible clinicians; in such case, the data reported would be used to determine their MIPS payment adjustment.
The following is a summary of the public comments received on the “MIPS Eligible Clinicians Who Practice in ASCs, HHAs, HOPDs” proposal and our responses:
As described in the CY 2017 Quality Payment Program final rule (81 FR 77057), we established the use of multiple identifiers that allow MIPS eligible clinicians to be measured as an individual or collectively through a group's performance and that the same identifier be used for all four performance categories. While we have multiple identifiers for participation and performance, we established the use of a single identifier, TIN/NPI, for applying the MIPS payment adjustment, regardless of how the MIPS eligible clinician is assessed.
As established in the CY 2017 Quality Payment Program final rule (81 FR 77058), we define a MIPS eligible clinician at § 414.1305 to mean the use of 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 is considered a different MIPS eligible clinician, and MIPS performance is assessed separately for each TIN under which an individual bills.
As established in the CY 2017 Quality Payment Program final rule (81 FR 77059), we codified 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.
As described in the CY 2017 Quality Payment Program final rule (81 FR 77060), we established that each eligible clinician who is a participant of an APM Entity is identified by a unique APM participant identifier. The unique APM participant identifier is 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). We codified 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, TIN, and NPI for each participating eligible clinician.
As established in the CY 2017 Quality Payment Program final rule (81 FR 77061 through 77062), we defined 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 clinician group or under a different billing number or tax identifier. Additionally, we established
We used the term “new Medicare-enrolled eligible clinician determination period” to refer to the 12 months of a calendar year applicable to the performance period. During the new Medicare-enrolled eligible clinician determination period, we conduct eligibility determinations on a quarterly basis to the extent that is technically feasible to identify new Medicare-enrolled eligible clinicians that would be excluded from the requirement to participate in MIPS for the applicable performance period.
In the CY 2017 Quality Payment Program final rule (81 FR 77062), we established at § 414.1305 that a QP (as defined at § 414.1305) is not a MIPS eligible clinician, and therefore, is excluded from MIPS. Also, we established that a Partial QP (as defined at § 414.1305) who does not report on applicable measures and activities that are required to be reported under MIPS for any given performance period in a year is not a MIPS eligible clinician, and therefore, is excluded from MIPS.
Section 1848(q)(1)(C)(ii)(III) of the Act provides that the definition of a MIPS eligible clinician does not include 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) The minimum number, as determined by the Secretary, of Part B-enrolled individuals who are treated by the eligible clinician for a particular performance period; (2) the minimum number, as determined by the Secretary, of items and services furnished to Part B-enrolled individuals by the eligible clinician for a particular performance period; and (3) the minimum amount, as determined by the Secretary, of allowed charges billed by the eligible clinician for a particular performance period.
In the CY 2017 Quality Payment Program final rule (81 FR 77069 through 77070), we defined MIPS eligible clinicians or groups who do not exceed the low-volume threshold at § 414.1305 as an individual MIPS eligible clinician or group who, during the low-volume threshold determination period, has Medicare Part B allowed charges less than or equal to $30,000 or provides care for 100 or fewer Part B-enrolled Medicare beneficiaries. We established at § 414.1310(b) that for a year, eligible clinicians who do not exceed the low-volume threshold (as defined at § 414.1305) are excluded from MIPS for the performance period for a given calendar year.
In the CY 2017 Quality Payment Program final rule (81 FR 77069 through 77070), we defined 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. The initial 12-month segment of the low-volume threshold determination period spans 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 includes a 60-day claims run out, which allows 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 spans 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 includes a 60-day claims run out, which allows us to inform additional eligible clinicians and groups of their low-volume status during the performance period.
We recognize that individual MIPS eligible clinicians and groups that are small practices or practicing in designated rural areas face unique dynamics and challenges such as fiscal limitations and workforce shortages, but serve as a critical access point for care and provide a safety net for vulnerable populations. Claims data shows that approximately 15 percent of individual MIPS eligible clinicians (TIN/NPIs) are considered to be practicing in rural areas after applying all exclusions. Also, we have heard from stakeholders that MIPS eligible clinicians practicing in small practices and designated rural areas tend to have a patient population with a higher proportion of older adults, as well as higher rates of poor health outcomes, co-morbidities, chronic conditions, and other social risk factors, which can result in the costs of providing care and services being significantly higher compared to non-rural areas. We also have heard from many solo practitioners and small practices that still face challenges and additional resource burden in participating in the MIPS.
In the CY 2017 Quality Payment Program final rule, we did not establish an adjustment for social risk factors in assessing and scoring performance. In response to the CY 2017 Quality Payment Program final rule, we received public comments indicating that individual MIPS eligible clinicians and groups practicing in designated rural areas would be negatively impacted and at a disadvantage if assessment and scoring methodology did not adjust for social risk factors. Additionally, commenters expressed concern that such individual MIPS eligible clinicians and groups may be disproportionately more susceptible to lower performance scores across all performance categories and negative MIPS payments adjustments, and as a result, such outcomes may further strain already limited fiscal resources and workforce shortages, and negatively impact access to care (reduction and/or elimination of available services).
After the consideration of stakeholder feedback, we proposed to modify the low-volume threshold policy established in the CY 2017 Quality Payment Program final rule (82 FR 30024). We stated that we believe that increasing the dollar amount and beneficiary count of the low-volume threshold would further reduce the number of eligible clinicians that are required to participate in the MIPS, which would reduce the burden on individual MIPS eligible clinicians and groups practicing in small practices and designated rural areas. Based on our analysis of claims data, we found that increasing the low-volume threshold to exclude individual eligible clinicians or groups that have Medicare Part B allowed charges less than or equal to $90,000 or that provide care for 200 or fewer Part B-enrolled Medicare beneficiaries will exclude approximately 134,000 additional clinicians from MIPS from the approximately 700,000 clinicians that would have been eligible based on the low-volume threshold that was finalized in the CY 2017 Quality Payment Program final rule. Almost half of the additionally excluded clinicians are in small practices, and approximately 17 percent are clinicians from practices in designated rural areas. Applying this
We believe that increasing the number of such individual eligible clinicians and groups excluded from MIPS participation would reduce burden and mitigate, to the extent feasible, the issue surrounding confounding variables impacting performance under the MIPS. Therefore, beginning with the 2018 MIPS performance period, we proposed to increase the low-volume threshold. Specifically, at § 414.1305, we proposed to define an individual MIPS eligible clinician or group who does 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 allowed charges less than or equal to $90,000 or provides care for 200 or fewer Part B-enrolled Medicare beneficiaries. This would mean that approximately 37 percent of individual eligible clinicians and groups would be eligible for MIPS based on the low-volume threshold exclusion (and the other exclusions). However, approximately 65 percent of Medicare payments would still be captured under MIPS as compared to 72.2 percent of Medicare payments under the CY 2017 Quality Payment Program final rule.
We recognize that increasing the dollar amount and beneficiary count of the low-volume threshold would increase the number of individual eligible clinicians and groups excluded from MIPS. We assessed various levels of increases and found that $90,000 as the dollar amount and 200 as the beneficiary count balances the need to account for individual eligible clinicians and groups who face additional participation burden while not excluding a significant portion of the clinician population.
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 eligible clinicians who practice in APMs under the APM scoring standard at the APM Entity level, in which APM Entities do not exceed the low-volume threshold. In such cases, the eligible clinicians participating in the MIPS APM Entity would be excluded from the MIPS requirements for the applicable performance period and not subject to a MIPS payment adjustment for the applicable year. Such an exclusion would not affect an APM Entity's QP determination if the APM Entity is an Advanced APM.
In the CY 2017 Quality Payment Program final rule, we established 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 (81 FR 77069 through 77070). We defined 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. Based on our analysis of data from the initial segment of the low-volume threshold determination period for performance periods occurring in 2017 (that is, data spanning from September 1, 2015 to August 31, 2016), we found that it may not be necessary to include a 60-day claims run out since we could achieve a similar outcome for such eligibility determinations by utilizing a 30-day claims run out.
In our comparison of data analysis results utilizing a 60-day claims run out versus a 30-day claims run out, there was a 1 percent decrease in data completeness. The small decrease in data completeness would not substantially impact individual MIPS eligible clinicians or groups regarding low-volume threshold determinations. We believe that a 30-day claims run out would allow us to complete the analysis and provide such determinations in a more timely manner. For performance periods occurring in 2018 and future years, we proposed a modification to the low-volume threshold determination period, in which 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 30-day claims run out; and 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 30-day claims run out (82 FR 30025). We stated that the proposal would only change the duration of the claims run out, not the 12-month timeframes used for the first and second segments of data analysis.
For purposes of the 2020 MIPS payment year, we would initially identify individual eligible clinicians and groups that do not exceed the low-volume threshold based on 12 months of data starting from September 1, 2016 to August 31, 2017. To account for the identification of additional individual eligible clinicians and groups that do not exceed the low-volume threshold during performance periods occurring in 2018, we would conduct another eligibility determination analysis based on 12 months of data starting from September 1, 2017 to August 31, 2018. We would 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 would continue to be excluded from MIPS for the duration of the performance period regardless of the results of the second eligibility determination analysis. We established our policy to include two eligibility determination analyses in order to prevent any potential confusion for an individual eligible clinician or group to know whether or not participate in MIPS; also, such policy makes it clear from the onset as to which individual eligible clinicians and groups would be required to participate in MIPS. We would 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 note that low-volume threshold determinations are made at the individual and group level, and not at the virtual group level.
As noted above, section 1848(q)(1)(C)(iv) of the Act requires the
In order to expand the ways in which claims data could be analyzed for purposes of determining a more comprehensive assessment of the low-volume threshold, we have assessed the option of establishing a low-volume threshold for items and services furnished to Part-B enrolled individuals by an eligible clinician. We have considered defining items and services by using the number of patient encounters or procedures associated with a clinician. Defining items and services by patient encounters would assess each patient per visit or encounter with the eligible clinician. We believe that defining items and services by using the number of patient encounters or procedures is a simple and straightforward approach for stakeholders to understand. However, we are concerned that using this unit of analysis could incentivize clinicians to focus on volume of services rather than the value of services provided to patients. Defining items and services by procedure would tie a specific clinical procedure furnished to a patient to a clinician. We solicited public comment on the methods of defining items and services furnished by clinicians described in this paragraph above and alternate methods of defining items and services (82 FR 30025 through 30026).
For the individual eligible clinicians and groups that would be excluded from MIPS participation as a result of an increased low-volume threshold, we believe that in future years it would be beneficial to provide, to the extent feasible, such individual eligible clinicians and groups with the option to opt-in to MIPS participation if they might otherwise be excluded under the low-volume threshold, such as where they only meet one of the threshold determinations (including a third determination based on Part B items and services, if established). For example, if a clinician meets the low-volume threshold of $90,000 in allowed charges, but does not meet the threshold of 200 patients or, if established, the threshold pertaining to Part B items and services, we believe the clinician should, to the extent feasible, have the opportunity to choose whether or not to participate in the MIPS and be subject to MIPS payment adjustments. We recognize that this choice would present additional complexity to clinicians in understanding all of their available options and may impose additional burden on clinicians by requiring them to notify us of their decision. Because of these concerns and our desire to establish options in a way that is a low-burden and user-focused experience for all MIPS eligible clinicians, we would not be able to offer this additional flexibility until performance periods occurring in 2019. Therefore, as a means of expanding options for clinicians and offering them the ability to participate in MIPS if they otherwise would not be included, for the purposes of the 2021 MIPS payment year, we proposed to provide clinicians the ability to opt-in to the MIPS if they meet or exceed one, but not all, of the low-volume threshold determinations, including as defined by dollar amount, beneficiary count or, if established, items and services (82 FR 30026).
We note that there may be additional considerations we should address for scenarios in which an individual eligible clinician or a group does not exceed the low-volume threshold and opts-in to participate in MIPS. We therefore sought comment on any additional considerations we should address when establishing this opt-in policy. Additionally, we note that there is the potential with this opt-in policy for there to be an impact on our ability to create quality benchmarks that meet our sample size requirements. For example, if particularly small practices or solo practitioners with low Part B beneficiary volumes opt-in, such clinicians may lack sufficient sample size to be scored on many quality measures, especially measures that do not apply to all of a MIPS eligible clinician's patients. We therefore sought comment on how to address any potential impact on our ability to create quality benchmarks that meet our sample size requirements (82 FR 30026).
The following is a summary of the public comments received on the “Low-Volume Threshold” proposals and our responses:
We note that the low-volume threshold is different from the other 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. In the CY 2017 Quality Payment Program final rule (82 FR 77071) we considered aligning how MIPS exclusions would be applied at the group level. We recognized that alignment would provide a uniform application across exclusions and offer simplicity, but we also believed that 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 finalized that we would 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. We appreciate the other concerns and recommendations provided by the commenters. We received a range of suggestions and considered the various options. We are finalizing our proposal to exclude an individual MIPS eligible clinician or group that, during the low-volume threshold determination period, has Medicare Part B allowed charges less than or equal to $90,000 or provides care for 200 or fewer Part B-enrolled Medicare beneficiaries. In this final rule with comment period, we are requesting additional comments regarding the application of low-volume threshold at the group level.
As discussed in the CY 2017 Quality Payment Program final rule, we established the following requirements for groups (81 FR 77072):
• Individual eligible clinicians and individual MIPS eligible clinicians will have their performance assessed as a group as part of a single TIN associated with two or more eligible clinicians (including at least one MIPS eligible clinician), as identified by an NPI, who have reassigned their Medicare billing rights to the TIN (at § 414.1310(e)(1)).
• 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 (at § 414.1310(e)(2)).
• Individual eligible clinicians and individual MIPS eligible clinicians within a group must aggregate their performance data across the TIN to have their performance assessed as a group (at § 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 (at § 414.1310(e)(4)).
We stated in the CY 2017 Quality Payment Program final rule that groups attest to their group size for purpose of using the CMS Web Interface or identifying as a small practice (81 FR 77057). In section II.C.1.c. of this final rule with comment period, we are finalizing our proposal to modify the way in which we determine small practice size by establishing a process under which CMS would utilize claims data to make small practice size determinations. In addition, in section II.C.4.e. of this final rule comment period, we are finalizing our proposal to establish a policy under which CMS would utilize claims data to determine group size for groups of 10 or fewer eligible clinicians seeking to form or join a virtual group.
As noted in the CY 2017 Quality Payment Program final rule, group size would be determined before exclusions are applied (81 FR 77057). We note that group size determinations are based on the number of NPIs associated with a TIN, which would include individual eligible clinicians (NPIs) who may be excluded from MIPS participation and do not meet the definition of a MIPS eligible clinician.
As discussed in the CY 2017 Quality Payment Program final rule (81 FR 77072 through 77073), we established the following policies:
• 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 mechanisms, groups must work with appropriate third party intermediaries 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, 2018, for performance periods occurring in 2018). We note that groups participating in APMs that require APM Entities to report using the CMS Web Interface are not required to register for the CMS Web Interface or administer the CAHPS for MIPS survey separately from the APM.
When groups submit data utilizing third party intermediaries, such as a qualified registry, QCDR, or EHR, we are able to obtain group information from the third party intermediary and discern whether the data submitted represents group submission or individual submission once the data are submitted.
In the CY 2017 Quality Payment Program final rule (81 FR 77072 through 77073), we discussed the implementation of a voluntary registration process if technically feasible. Since the publication of the CY 2017 Quality Payment Program final rule, we have determined that it is not technically feasible to develop and build a voluntary registration process. Until further notice, we are not implementing a voluntary registration process.
Also, in the CY 2017 Quality Payment Program final rule (81 FR 77075), we expressed our commitment to pursue the active engagement of stakeholders throughout the process of establishing and implementing virtual groups. Please refer to the CY 2018 Quality Payment Program proposed rule (82 FR 30027) for a full discussion of the public comments and additional stakeholder feedback we received in response to the CY 2017 Quality Payment Program final rule and additional stakeholder feedback gathered through hosting several virtual group listening sessions and convening user groups.
As discussed in the CY 2018 Quality Payment Program proposed rule (82 FR 30027), one of the overarching themes we have heard is that we make an option available to groups that would allow a portion of a group to report as a separate subgroup on measures and activities that are more applicable to the subgroup and be assessed and scored accordingly based on the performance of the subgroup. In future rulemaking, we intend to explore the feasibility of establishing group-related policies that would permit participation in MIPS at a subgroup level and create such functionality through a new identifier. Therefore, we solicited public comment on the ways in which participation in MIPS at the subgroup level could be established. In addition, in this final rule with comment period, we are seeking comment on additional ways to define a group, not solely based on a TIN. For example, redefining a group to allow for practice sites to be reflected and/or for specialties within a TIN to create groups.
We received several comments on subgroup level policies and will take them into consideration for future rulemaking.
There are generally three ways to participate in MIPS: (1) Individual-level reporting; (2) group-level reporting; and (3) virtual group-level reporting. In the CY 2018 Quality Payment Program proposed rule (82 FR 30027 through 30034), we proposed to establish requirements for MIPS participation at the virtual group level.
Section 1848(q)(5)(I) of the Act provides for the use of voluntary virtual groups for certain assessment purposes, including the election of certain practices to be a virtual group and the requirements for the election process. Section 1848(q)(5)(I)(i) of the Act provides that MIPS eligible clinicians electing to be a virtual group must: (1) Have their performance assessed for the quality and cost performance categories in a manner that applies the combined performance of all the MIPS eligible clinicians in the virtual group to each MIPS eligible clinician in the virtual group for the applicable performance period; and (2) be scored for the quality and cost performance categories based on such assessment for the applicable performance period. Section 1848(q)(5)(I)(ii) of the Act requires the Secretary to establish and implement, in accordance with section 1848(q)(5)(I)(iii) of the Act, a process that allows an individual MIPS eligible clinician or a group consisting of not more than 10 MIPS eligible clinicians to elect, for a performance period, to be a virtual group with at least one other such individual MIPS eligible clinician or group. Virtual groups may be based on appropriate classifications of providers, such as by geographic areas or by provider specialties defined by nationally recognized specialty boards of certification or equivalent certification boards.
Section 1848(q)(5)(I)(iii) of the Act provides that the virtual group election process must include the following requirements: (1) An individual MIPS eligible clinician or group electing to be in a virtual group must make their election prior to the start of the applicable performance period and cannot change their election during the performance period; (2) an individual MIPS eligible clinician or group may elect to be in no more than one virtual group for a performance period, and, in the case of a group, the election applies to all MIPS eligible clinicians in the
As noted above, section 1848(q)(5)(I)(ii) of the Act requires the Secretary to establish and implement, in accordance with section 1848(q)(5)(I)(iii) of the Act, a process that allows an individual MIPS eligible clinician or group consisting of not more than 10 MIPS eligible clinicians to elect, for a performance period, to be a virtual group with at least one other such individual MIPS eligible clinician or group. Given that section 1848(q)(5)(I)(iii)(III) of the Act provides that a virtual group is a combination of TINs, we interpreted the references to an “individual” MIPS eligible clinician in section 1848(q)(5)(I)(ii) of the Act to mean a solo practitioner, which, for purposes of section 1848(q)(5)(I) of the Act, we proposed to define as a MIPS eligible clinician (as defined at § 414.1305) who bills under a TIN with no other NPIs billing under such TIN (82 FR 30027).
Also, we recognized that a group (TIN) may include not only NPIs who meet the definition of a MIPS eligible clinician, but also NPIs who do not meet the definition of a MIPS eligible clinician at § 414.1305 or who are excluded from the definition of a MIPS eligible clinician under § 414.1310(b) or (c). Thus, we interpreted the references to a group “consisting of not more than 10” MIPS eligible clinicians in section 1848(q)(5)(I)(ii) of the Act to mean a group with 10 or fewer eligible clinicians (as such terms are defined at § 414.1305) (82 FR 30027). Under § 414.1310(d), the MIPS payment adjustment would apply only to NPIs in the virtual group who meet the definition of a MIPS eligible clinician at § 414.1305 and who are not excluded from the definition of a MIPS eligible clinician under § 414.1310(b) or (c). We noted that groups must include at least one MIPS eligible clinician in order to meet the definition of a group at § 414.1305 and thus be eligible to form or join a virtual group.
We proposed to define a virtual group at § 414.1305 as a combination of two or more TINs composed of a solo practitioner (that is, a MIPS eligible clinician (as defined at § 414.1305) who bills under a TIN with no other NPIs billing under such TIN) or a group with 10 or fewer eligible clinicians (as such terms are defined at § 414.1305) under the TIN that elects to form a virtual group with at least one other such solo practitioner or group for a performance period for a year (82 FR 30027 through 30028).
With regard to the low-volume threshold, we recognized that such determinations are made at the individual and group level, but not at the virtual group level (82 FR 30031). For example, if an individual MIPS eligible clinician is part of a practice that is participating in MIPS (that is, reporting) at the individual level, then the low-volume threshold determination is made at the individual level. Whereas, if an individual MIPS eligible clinician is part of a practice that is participating in MIPS (that is, reporting) at the group level, then the low-volume threshold determination is made at the group level and would be applicable to such MIPS eligible clinician regardless of the low-volume threshold determination made at the individual level. Similarly, if a solo practitioner or a group with 10 or fewer eligible clinicians seeks to participate in MIPS (that is, report) at the virtual group level, then the low-volume threshold determination made at the individual or group level, respectively, would be applicable to such solo practitioner or group. Thus, solo practitioners or groups with 10 or fewer eligible clinicians that are determined not to exceed the low-volume threshold at the individual or group level, respectively, would not be eligible to participate in MIPS as an individual, group, or virtual group, as applicable.
Given that a virtual group must be a combination of TINs, we recognized that the composition of a virtual group could include, for example, one solo practitioner (NPI) who is practicing under multiple TINs (TIN A and TIN B), in which the solo practitioner would be able to form a virtual group with his or her own self based on each TIN assigned to the solo practitioner (TIN A/NPI and TIN B/NPI) (82 FR 30032). As discussed in section II.C.4.b.(3) of this final rule with comment period, we did not propose to establish a limit on the number of TINs that may form a virtual group at this time.
Lastly, we noted that qualification as a virtual group for purposes of MIPS does not change the application of the physician self-referral law to a financial relationship between a physician and an entity furnishing designated health services, nor does it change the need for such a financial relationship to comply with the physician self-referral law (82 FR 30028).
We refer readers to section II.C.4.b.(3) of this final rule with comment period for a summary of the public comments we received on these proposals and our responses.
Additionally, we recognized that there are circumstances in which a TIN may have one portion of its NPIs participating under the generally applicable MIPS scoring criteria while the remaining portion of NPIs under the TIN is participating in a MIPS APM or an Advanced APM under the MIPS APM scoring standard (82 FR 30028). To clarify, for all groups, including those containing participants in a MIPS APM or an Advanced APM, the group's performance assessment will be based on the performance of the entire TIN. Generally, for groups other than those containing participants in a MIPS APM or an Advanced APM, each MIPS eligible clinician under the TIN (TIN/NPI) receives a MIPS adjustment based on the entire group's performance assessment (entire TIN). For groups containing participants in a MIPS APM or an Advanced APM, only the portion of the TIN that is being scored for MIPS according to the generally applicable scoring criteria (TIN/NPI) receives a MIPS adjustment based on the entire group's performance assessment (entire TIN). The remaining portion of the TIN that is being scored according to the APM scoring standard (TIN/NPI) receives a MIPS adjustment based on that standard. We noted that such participants may be excluded from MIPS if they achieve QP or Partial QP status. For more information, we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77058, 77330 through 77331).
We proposed to apply a similar policy to groups, including those containing participants in a MIPS APM or an Advanced APM, that are participating in MIPS as part of a virtual group (82 FR 30028). Specifically, for groups other than those containing participants in a MIPS APM or an Advanced APM, each MIPS eligible clinician under the TIN (TIN/NPI) would receive a MIPS adjustment based on the virtual group's combined performance assessment (combination of TINs). For groups containing participants in a MIPS APM or an Advanced APM, only the portion of the TIN that is being scored for MIPS according to the generally applicable scoring criteria (TIN/NPI) would receive a MIPS adjustment based on the virtual
We refer readers to section II.C.4.b.(3) of this final rule with comment period for a summary of the public comments we received on these proposals and our responses.
As noted above, the statute provides the Secretary with discretion to establish appropriate classifications regarding the composition of virtual groups, such as by geographic area or by specialty. We recognized that virtual groups would each have unique characteristics and varying patient populations. However, we believe it is important for virtual groups to have the flexibility to determine their own composition at this time, and, as a result, we did not propose to establish any such classifications regarding virtual group composition (82 FR 30028).
We further noted that the statute does not limit the number of TINs that may form a virtual group, and we did not propose to establish such a limit at this time (82 FR 30028). We did consider proposing to establish such a limit, such as 50 or 100 participants. In particular, we were concerned that virtual groups of too substantial a size (for example, 10 percent of all MIPS eligible clinicians in a given specialty or sub-specialty) may make it difficult to compare performance between and among clinicians. We believe that limiting the number of virtual group participants could eventually assist virtual groups as they aggregate their performance data across the virtual group. However, we believe that as we initially implement virtual groups, it is important for virtual groups to have the flexibility to determine their own size, and thus, the better approach is not to place such a limit on virtual group size. We will monitor the ways in which solo practitioners and groups with 10 or fewer eligible clinicians form virtual groups and may propose to establish appropriate classifications regarding virtual group composition or a limit on the number of TINs that may form a virtual group in future rulemaking as necessary.
We solicited public comment on these proposals, as well as our approach of not establishing appropriate classifications (such as by geographic area or by specialty) regarding virtual group composition or a limit on the number of TINs that may form a virtual group at this time.
We noted that we received public comments in response to the CY 2017 Quality Payment Program final rule and additional stakeholder feedback by hosting several virtual group listening sessions and convening user groups (82 FR 30028). We refer readers to the CY 2018 Quality Payment Program proposed rule (82 FR 30027) for a summary of these comments and our response.
The following is a summary of the public comments received regarding our proposals, as well as our approach of not establishing appropriate classifications (such as by geographic area or by specialty) regarding virtual group composition or a limit on the number of TINs that may form a virtual group at this time.
In regard to determining TIN size for purposes of virtual group eligibility, we count each NPI associated with a TIN in order to determine whether or not a TIN exceeds the threshold of 10 NPIs, which is an approach that we believe provides continuity over time if the definition of a MIPS eligible clinician is expanded in future years under section 1848(q)(1)(C)(i)(II) of the Act to include other eligible clinicians. We considered an alternative approach for determining TIN size, which would determine TIN size for virtual group eligibility based on NPIs who are MIPS eligible clinicians. However, as we conducted a comparative assessment of the application of such alternative approach with the current definition of a MIPS eligible clinician (as defined at § 414.1305) and a potential expanded definition of a MIPS eligible clinician, we found that such an approach could create confusion as to which factors determine virtual group eligibility and cause the pool of virtual group eligible TINs to significantly be reduced once the definition of a MIPS eligible clinician would be expanded, which may impact a larger portion of virtual groups that intend to participate in MIPS as a virtual group for consecutive performance periods. Such impact would be the result of the current definition of a MIPS eligible clinician being narrower than the potential expanded definition of a MIPS eligible clinician. For example, under the recommended approach, a TIN with a total of 15 NPIs (10 MIPS eligible clinicians and 5 eligible clinicians) would not exceed the threshold of 10 MIPS eligible clinicians and would be eligible to participate in MIPS as a virtual group for the 2018 performance period; however, if the definition of a MIPS eligible clinician were expanded through rulemaking for the 2019 performance period, such TIN, with no change in TIN size (15 NPIs), would exceed the threshold of 10 MIPS eligible clinicians if 1 or more of the 5 eligible clinicians met the expanded definition
We are also finalizing our proposal that for groups (TINs) that participate in MIPS as part of a virtual group and do not contain participants in a MIPS APM or an Advanced APM, each MIPS eligible clinician under the TIN (each TIN/NPI) will receive a MIPS payment adjustment based on the virtual group's combined performance assessment (combination of TINs). For groups (TINs) that participate in MIPS as part of a virtual group and contain participants in a MIPS APM or an Advanced APM, only the portion of the TIN that is being scored for MIPS according to the generally applicable scoring criteria will receive a MIPS adjustment based on the virtual group's combined performance assessment (combination of TINs). As discussed in section II.C.6.g. of this final rule with comment period, the remaining portion of the TIN that is being scored according to the APM scoring standard will receive a MIPS payment adjustment based on that standard. We note that such participants may be excluded from MIPS if they achieve QP or Partial QP status.
At this juncture, we are not establishing additional classifications (such as by geographic area or by specialty) regarding virtual group composition or a limit on the number of TINs that may form a virtual group.
To ensure that we have accurately captured all of the MIPS eligible clinicians participating in a virtual group, we proposed that each MIPS eligible clinician who is part of a virtual group would be identified by a unique virtual group participant identifier (82 FR 30028 through 30029). The unique virtual group participant identifier would be a combination of three identifiers: (1) Virtual group identifier (established by CMS; for example, XXXXXX); (2) TIN (9 numeric characters; for example, XXXXXXXXX); and (3) NPI (10 numeric characters; for example, 1111111111). For example, a virtual participant identifier could be VG-XXXXXX, TIN-XXXXXXXXX, NPI-11111111111. We solicited public comment on this proposal.
The following is a summary of the public comments received regarding our proposal.
In the CY 2017 Quality Payment Program final rule (81 FR 77070 through 77072), we finalized various requirements for groups under MIPS at § 414.1310(e), under which groups electing to report at the group level are assessed and scored across the TIN for all four performance categories. In the CY 2018 Quality Payment Program proposed rule (82 FR 30029), we proposed to apply our previously finalized and proposed group-related policies to virtual groups, unless otherwise specified. We recognized that there are instances in which we may need to clarify or modify the application of certain previously finalized or proposed group-related policies to virtual groups, such as the definition of a non-patient facing MIPS eligible clinician; small practice, rural area and HPSA designations; and groups that contain participants in a MIPS APM or an Advanced APM (see section II.C.4.b. of this final rule with comment period). More generally, such policies may include, but are not limited to, those that require a calculation of the number of NPIs across a TIN (given that a virtual group is a combination of TINs), the application of any virtual group participant's status or designation to the entire virtual group, and the applicability and availability of certain measures and activities to any virtual group participant and to the entire virtual group.
We refer readers to section II.C.4.d.(5) of this final rule with comment period for a summary of the public comments we received on these proposals and our responses.
With regard to the applicability of the non-patient facing MIPS eligible clinician-related policies to virtual groups, in the CY 2017 Quality Payment Program final rule (81 FR 77048 through 77049), we defined the term non-patient facing MIPS eligible clinician 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. In the CY 2018 Quality Payment Program proposed rule (82 FR 30021, 30029), we proposed to modify the definition of a non-patient facing MIPS eligible clinician to include clinicians in a virtual group, provided that more than 75 percent of the NPIs billing under the virtual group's TINs meet the definition of a non-patient facing individual MIPS eligible clinician during the non-patient facing determination period. We noted that other policies previously established and proposed in the proposed rule for non-patient facing groups would apply to virtual groups (82 FR 30029). For example, as discussed in section II.C.1.e. of this final rule with comment period, virtual groups determined to be non-patient facing would have their advancing care information performance category automatically reweighted to zero.
We refer readers to section II.C.4.d.(5) of this final rule with comment period for a summary of the public comments we received on these proposals and our responses.
With regard to the application of small practice status to virtual groups, in the CY 2017 Quality Payment Program final rule (81 FR 77188), we defined the term small practices at § 414.1305 as practices consisting of 15 or fewer clinicians and solo practitioners. In the CY 2018 Quality Payment Program proposed rule (82 FR 30019, 30029), we proposed that a virtual group would be identified as a small practice if the virtual group does not have 16 or more eligible clinicians. In addition, we proposed for performance periods occurring in 2018 and future years to identify small practices by utilizing claims data; for performance periods occurring in 2018, we would identify small practices based on 12 months of data starting from September 1, 2016 to August 31, 2017 (82 FR 30019 through 30020). We refer readers to section II.C.1.c. of this final rule with comment period for the discussion of our proposal to identify small practices by utilizing claims data. We refer readers to section II.C.4.d.(3) of this final rule with comment period for the discussion regarding how small practice status would apply to virtual groups for scoring under MIPS.
We refer readers to section II.C.4.d.(5) of this final rule with comment period for a summary of the public comments we received on our proposal to apply small practice status to virtual groups and our responses.
In the CY 2018 Quality Payment Program proposed rule (82 FR 30020 through 30021), we proposed to determine rural area and HPSA practice designations at the individual, group, and virtual group level. Specifically, for performance periods occurring in 2018 and future years, we proposed that an individual MIPS eligible clinician, a group, or a virtual group with multiple practices under its TIN or TINs within a virtual group would be designated as a rural area or HPSA practice if more than 75 percent of NPIs billing under the individual MIPS eligible clinician or group's TIN or within a virtual group, as applicable, are designated in a ZIP code as a rural area or HPSA. We noted that other policies previously established and proposed in the proposed rule for rural area and HPSA groups would apply to virtual groups (82 FR 30029). We note that in section II.C.7.b.(1)(b) of this final rule with comment period, we describe our scoring proposals for practices that are in a rural area.
We refer readers to section II.C.4.d.(5) of this final rule with comment period for a summary of the public comments we received on these proposals and our responses.
As noted above, we proposed to apply our previously finalized and proposed group-related policies to virtual groups, unless otherwise specified (82 FR 30029). In particular, we recognized that the measures and activities applicable and available to groups would also be applicable and available to virtual groups. Virtual groups would be required to meet the reporting
The following is a summary of the public comments received regarding our proposals.
We note that as with virtual group reporting for the other MIPS performance categories, to report as a virtual group, the virtual group will need to aggregate data for all of the individual MIPS eligible clinicians within the virtual group for which its TINs have data in CEHRT. For solo practitioners and groups that choose to report as a virtual group, performance on the advancing care information performance category objectives and measures will be reported and evaluated at the virtual group level. The virtual group will submit the data that its TINs have utilizing CEHRT and exclude data not collected from a non-certified EHR system. While we do not expect that every MIPS eligible clinician in a virtual group will have access to CEHRT, or that every measure will apply to every clinician in the virtual group, only those data contained in CEHRT should be reported for the advancing care information performance category.
For example, the virtual group calculation of the numerators and denominators for each measure must reflect all of the data from the individual MIPS eligible clinicians (unless a clinician can be excluded) that have been captured in CEHRT for the given advancing care information performance category measure. If the groups (not including solo practitioners) that are part of a virtual group have CEHRT that is capable of supporting group level reporting, the virtual group would submit the aggregated data across the TINs produced by the CEHRT. If a group (TIN) that is part of a virtual group does not have CEHRT that is capable of supporting group level reporting, such 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 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 recognize that it can be difficult to identify unique patients across a virtual group for the purposes of aggregating data on the advancing care information performance category measures, particularly when TINs within a virtual group may be using multiple CEHRT systems. For the 2018 performance period, TINs within virtual groups may be using systems which are certified to different CEHRT Editions. We consider “unique patients” to be individual patients treated by a TIN within a virtual group who would typically be counted as one patient in the denominator of an advancing care information performance category measure. This patient may see multiple MIPS eligible clinicians within a TIN that is part of a virtual group, or may see MIPS eligible clinicians at multiple practice sites of a TIN that is part of a virtual group. When aggregating performance on advancing care information measures for virtual group level reporting, we do not require that a virtual group determines that a patient seen by one MIPS eligible clinician (or at one location in the case of TINs working with multiple CEHRT systems) is not also seen by another MIPS eligible clinician in the TIN that is part of the virtual group or captured in a different CEHRT system. Virtual groups are provided with some flexibility as to the method for counting unique patients in the denominators to accommodate such scenarios where aggregation may be hindered by systems capabilities across multiple CEHRT platforms. We refer readers to section II.C.6.f.(4) of this final rule with comment for the discussion regarding certification requirements.
Moreover, we note that virtual groups will have an opportunity to request a targeted review of their MIPS payment adjustment factor(s) for a performance period. In regard to an audit process, virtual groups would be subject to the MIPS data validation and auditing requirements as described in section II.C.9.c. of this final rule with comment period.
We are also finalizing our proposal to modify the definition of a non-patient facing MIPS eligible clinician at § 414.1305 to include a virtual group, provided that more than 75 percent of the NPIs billing under the virtual group's TINs meet the definition of a non-patient facing individual MIPS eligible clinician during the non-patient facing determination period. Other previously finalized and proposed policies related to non-patient facing MIPS eligible clinicians would apply to such virtual groups.
We are also finalizing our proposal that a virtual group will be considered a small practice if a virtual group consists of 15 or fewer eligible clinicians. Other previously finalized and proposed policies related to small practices would apply to such virtual groups.
We are also finalizing our proposal that a virtual group will be designated as a rural area or HPSA practice if more than 75 percent of NPIs billing under the virtual group's TINs are designated in a ZIP code as a rural area or HPSA, the virtual group's TINs are designated as rural areas or HPSA practices. Other previously finalized and proposed policies related to rural area or HPSA practices would apply to such virtual groups.
In response to public comments, we are also finalizing that a virtual group will be considered a certified or recognized patient-centered medical home or comparable specialty practice under § 414.1380(b)(3)(iv) if at least 50 percent of the practices sites within the TINs are certified or recognized as a patient-centered medical home or comparable specialty practice.
As noted in section II.C.4.a. of this final rule with comment period, section 1848(q)(5)(I)(iii)(I) and (II) of the Act provides that the virtual group election process must include certain requirements, including that: (1) An individual MIPS eligible clinician or group electing to be in a virtual group must make their election prior to the start of the applicable performance period and cannot change their election during the performance period; and (2) an individual MIPS eligible clinician or group may elect to be in no more than one virtual group for a performance period, and, in the case of a group, the election applies to all MIPS eligible clinicians in the group. Accordingly, we proposed to codify at § 414.1315(a) that a solo practitioner (as defined at § 414.1305) or group consisting of 10 or fewer eligible clinicians (as such terms are defined at § 414.1305) electing to be in a virtual group must make their election prior to the start of the applicable performance period and cannot change their election during the performance period (82 FR 30029 through 30030). Virtual group participants may elect to be in no more than one virtual group for a performance period, and, in the case of a group, the election applies to all MIPS eligible clinicians in the group.
We noted that in the case of a TIN within a virtual group being acquired or merged with another TIN, or no longer operating as a TIN (for example, a group practice closes), during a performance period, such solo practitioner's or group's performance data would continue to be attributed to the virtual group (82 FR 30032). The remaining parties to the virtual group would continue to be part of the virtual group even if only one solo practitioner or group remains. We consider a TIN that is acquired or merged with another TIN, or no longer operating as a TIN (for example, a group practice closes), to mean a TIN that no longer exists or operates under the auspices of such TIN during a performance period.
In order to provide support and reduce burden, we intend to make technical assistance (TA) available, to the extent feasible and appropriate, to support clinicians who choose to come together as a virtual group. Clinicians can access the TA infrastructure and resources that they may already be utilizing. For Quality Payment Program year 3, we intend to provide an electronic election process if technically feasible. We proposed that clinicians who do not elect to contact their designated TA representative would still have the option of contacting the Quality Payment Program Service Center to obtain information pertaining to virtual groups (82 FR 30030).
We refer readers to section II.C.4.e.(3) of this final rule with comment period for a summary of the public comments we received on these proposals and our responses.
For performance periods occurring in 2018 future years, we proposed to establish a virtual group election period (82 FR 30030). Specifically, we proposed to codify at § 414.1315(a) that a solo practitioner (as defined at § 414.1305) or group consisting of 10 or fewer eligible clinicians (as such terms are defined at § 414.1305) electing to be in a virtual group must make their election by December 1 of the calendar year preceding the applicable performance period. A virtual group representative would be required to make the election, on behalf of the members of a virtual group, regarding the formation of a virtual group for the applicable performance period, by the election deadline. For example, a virtual group representative would need to make an election, on behalf of the members of a virtual group, by December 1, 2017 for the members of the virtual group to participate in MIPS as a virtual group during the CY 2018 performance period. We intend to publish the beginning date of the virtual group election period applicable to performance periods occurring in 2018 and future years in subregulatory guidance.
We refer readers to section II.C.4.e.(3) of this final rule with comment period for a summary of the public comments we received on these proposals and our responses.
We proposed to codify at § 414.1315(c) a two-stage virtual group election process, stage 1 of which is optional, for performance periods occurring in 2018 and 2019 (82 FR 30030 through 30032). Stage 1 pertains to virtual group eligibility determinations, and stage 2 pertains to virtual group formation. We noted that activity involved in stage 1 is not required, but a resource available to solo practitioners and groups with 10 or fewer eligible clinicians. Solo practitioners and groups that engage in stage 1 and are determined eligible for virtual group participation would proceed to stage 2; otherwise, solo practitioners and groups that do not engage in any activity during stage 1 would begin the election process at stage 2. Engaging in stage 1 would provide solo practitioners and groups with the option to confirm whether or not they are eligible to join or form a virtual group before going to the lengths of executing formal written agreements, submitting a formal election registration, allocating resources for virtual group implementation, and other related activities; whereas, by engaging directly in stage 2 as an initial step, solo practitioners and groups might conduct all such efforts to only have their election registration be rejected with no recourse or remaining time to amend and resubmit.
In stage 1, solo practitioners and groups with 10 or fewer eligible clinicians interested in forming or joining a virtual group would have the option to contact their designated TA representative in order to obtain information pertaining to virtual groups and/or determine whether or not they are eligible, as it relates to the practice size requirement of a solo practitioner or a group of 10 or fewer eligible clinicians, to participate in MIPS as a virtual group (§ 414.1315(c)(1)(i)). During stage 1 of the virtual group election process, we would determine whether or not a TIN is eligible to form or join a virtual group. In order for a solo practitioner to be eligible to form or join a virtual group, the solo practitioner would need to meet the definition of a solo practitioner at § 414.1305 and not be excluded from MIPS under § 414.1310(b) or (c). In order for a group to be eligible to form or join a virtual group, a group would need to meet the definition of a group at § 414.1305, have a TIN size that does not exceed 10 eligible clinicians, and not be excluded from MIPS under § 414.1310(b) or (c). For purposes of determining TIN size for virtual group participation eligibility, we coined the term “virtual group eligibility determination period” and defined it to mean an analysis of claims data during an assessment period of up to 5 months that would begin on July 1 and end as late as November 30 of the calendar year prior to the applicable performance period and includes a 30-day claims run out.
To capture a real-time representation of TIN size, we proposed to analyze up to 5 months of claims data on a rolling basis, in which virtual group eligibility determinations for each TIN would be updated and made available monthly (82 FR 30030). We noted that an eligibility determination regarding TIN size is based on a relative point in time within the 5-month virtual group eligibility determination period, and not made at the end of such 5-month determination period.
If at any time a TIN is determined to be eligible to participate in MIPS as part of a virtual group, the TIN would retain that status for the duration of the election period and the applicable performance period. TINs could determine their status by contacting their designated TA representative; otherwise, the TIN's status would be determined at the time that the TIN's virtual group election is submitted. For example, if a group contacted their designated TA representative on October 20, 2017, the claims data analysis would include the months of July through September of 2017, and, if determined not to exceed 10 eligible clinicians, the TIN's size would be determined at such time, and the TIN's eligibility status would be retained for the duration of the election period and the CY 2018 performance period. If another group contacted their designated TA representative on November 20, 2017, the claims data analysis would include the months of July through October of 2017, and, if determined not to exceed 10 eligible clinicians, the TIN's size would be determined at such time, and the TIN's eligibility status would be retained for the duration of the election period and the CY 2018 performance period.
We believe such a virtual group determination period process provides a relative representation of real-time TIN size for purposes of virtual group eligibility and allows solo practitioners and groups to know their real-time eligibility status immediately and plan accordingly for virtual group implementation. It is anticipated that starting in September of each calendar year prior to the applicable performance period, solo practitioners and groups would be able to contact their designated TA representative and inquire about virtual group participation eligibility. We noted that TIN size determinations are based on the number of NPIs associated with a TIN, which would include clinicians (NPIs) who do not meet the definition of a MIPS eligible clinician at § 414.1305 or who are excluded from MIPS under § 414.1310(b) or (c).
For groups that do not choose to participate in stage 1 of the election process (that is, the group does not request an eligibility determination), we will make an eligibility determination during stage 2 of the election process. If a group began the election process at stage 2 and if its TIN size is determined not to exceed 10 eligible clinicians and not excluded based on the low-volume threshold exclusion at the group level, the group is determined eligible to participate in MIPS as part of a virtual group, and such virtual group eligibility determination status would be retained for the duration of the election period and applicable performance period. Stage 2 pertains to virtual group formation. For stage two, we proposed the following (82 FR 30031):
• TINs comprising a virtual group must establish a written formal agreement between each member of a virtual group prior to an election (§ 414.1315(c)(2)(i)).
• On behalf of a virtual group, the official designated virtual group representative must submit an election by December 1 of the calendar year prior to the start of the applicable performance period (§ 414.1315(c)(2)(ii)). Such election will occur via email to the Quality Payment Program Service Center using the following email address for the 2018 and 2019 performance periods:
• The submission of a virtual group election must include, at a minimum, information pertaining to each TIN and NPI associated with the virtual group and contact information for the virtual group representative (§ 414.1315(c)(2)(iii)). A virtual group representative would submit the following type of information: Each TIN associated with the virtual group; each NPI associated with a TIN that is part of the virtual group; name of the virtual group representative; affiliation of the virtual group representative to the virtual group; contact information for the virtual group representative; and confirmation through acknowledgment that a formal written agreement has been established between each member of the virtual group (solo practitioner or group) prior to election and each eligible clinician in the virtual group is aware of participating in MIPS as a virtual group for an applicable performance period. Each party to the virtual group agreement must retain a copy of the virtual group's written agreement. We noted that the virtual group agreement is subject to the MIPS data validation and auditing requirements as described in section II.C.9.c. of this final rule with comment period.
• Once an election is made, the virtual group representative must contact their designated CMS contact to update any election information that changed during an applicable performance period at least one time prior to the start of an applicable submission period (§ 414.1315(c)(2)(iv)). Virtual groups will use the Quality Payment Program Service Center as their designated CMS contact; however, we will define this further in subregulatory guidance.
For stage 2 of the election process, we would review all submitted election information; confirm whether or not each TIN within a virtual group is eligible to participate in MIPS as part of a virtual group; identify the NPIs within each TIN participating in a virtual group that are excluded from MIPS in order to ensure that such NPIs would not receive a MIPS payment adjustment or, when applicable and when information is available, would receive a payment adjustment based on a MIPS APM scoring standard; calculate the low-volume threshold at the individual and group levels in order to determine whether or not a solo practitioner or group is eligible to participate in MIPS as part of a virtual group; and notify virtual groups as to whether or not they are considered official virtual groups for the applicable performance period. For virtual groups that are determined to have met the virtual group formation criteria and identified as an official virtual group participating in MIPS for an applicable performance period, we would contact the official designated virtual group representative via email notifying the virtual group of its official virtual group status and issuing a virtual group identifier for performance (as described in section II.C.4.c. of this final rule with comment period) that would accompany the virtual group's submission of performance data during the submission period.
As we engaged in various discussions with stakeholders during the rulemaking process through listening sessions and user groups, stakeholders indicated that many solo practitioners and small groups have limited resources and technical capacities, which may make it difficult for the entities to form virtual groups without sufficient time and technical assistance. Depending on the resources and technical capacities of the entities, stakeholders conveyed that it may take entities 3 to 18 months to prepare to participate in MIPS as a virtual group. The majority of stakeholders indicated that virtual groups would need at least 6 to 12 months prior to the start of the CY 2018 performance period to form virtual groups, prepare health IT systems, and train staff to be ready for the implementation of virtual group related activities by January 1, 2018.
We recognized that for the first year of virtual group formation and implementation prior to the start of the CY 2018 performance period, the timeframe for virtual groups to make an election by registering would be relatively short, particularly from the date we issue the publication of a final rule toward the end of the 2017 calendar year. To provide solo practitioners and groups with 10 or fewer eligible clinicians with additional time to assemble and coordinate resources, and form a virtual group prior to the start of the CY 2018 performance period, we provided virtual groups with an opportunity to make an election prior to the publication of our final rule. On October 11, 2017, the election period began and we issued information pertaining to the start date of the election process via subregulatory guidance, which can be accessed on the CMS Web site at
As previously noted, solo practitioners and groups participating in a virtual group would have the size of their TIN determined for eligibility purposes. We recognized that the size of a TIN may fluctuate during a performance period with eligible clinicians and/or MIPS eligible clinicians joining or leaving a group. For solo practitioners and groups that are determined eligible to form or join a virtual group based on the one-time determination per applicable performance period, any new eligible clinicians or MIPS eligible clinicians that join the TIN during the performance period would participate in MIPS as part of the virtual group. In such cases, we recognized that a solo practitioner or group may exceed 1 eligible clinician or 10 eligible clinicians, as applicable, associated with its TIN during an applicable performance period, but such solo practitioner or group would have been determined eligible to form or join a virtual group given that the TIN did not have more than 1 eligible clinician or 10 eligible clinicians, as applicable, associated with its TIN at the time of election. As previously noted, the virtual group representative would need to contact the Quality Payment Program Service Center to update the virtual group's information that was provided during the election period if any information changed during an applicable performance period at least one time prior to the start of an applicable submission period (for example, include new NPIs who joined a TIN that is part of a virtual group).
The following is a summary of the public comments received regarding our proposed election process for virtual groups.
As noted in section II.C.4.a. of this final rule with comment period, section 1848(q)(5)(I)(iii)(IV) of the Act provides that the virtual group election process must provide for formal written agreements among individual MIPS eligible clinicians (solo practitioners) and groups electing to be a virtual group. We proposed that each virtual group member (that is, each solo practitioner or group) would be required to execute formal written agreements with each other virtual group member to ensure that requirements and expectations of participation in MIPS are clearly articulated, understood, and agreed upon (82 FR 30032 through 30033). We noted that a virtual group may not include a solo practitioner or group as part of the virtual group unless an authorized person of the TIN has executed a formal written agreement. During the election process and submission of a virtual group election, a designated virtual group representative would be required to confirm through acknowledgement that an agreement is in place between each member of the virtual group. An agreement would be executed for at least one performance period. If an NPI joins or leaves a TIN, or a change is made to a TIN that impacts the agreement itself, such as a legal business name change, during the applicable performance period, a virtual group would be required to update the agreement to reflect such changes and submit changes to CMS via the Quality Payment Program Service Center.
We proposed, at § 414.1315(c)(3), that a formal written agreement between each member of a virtual group must include the following elements:
• Expressly state the only parties to the agreement are the TINs and NPIs of the virtual group (at § 414.1315(c)(3)(i)). For example, the agreement may not be between a virtual group and another entity, such as an independent practice association (IPA) or management company that in turn has an agreement with one or more TINs within the virtual group. Similarly, virtual groups should not use existing contracts between TINs that include third parties.
• Be executed on behalf of the TINs and the NPIs by individuals who are authorized to bind the TINs and the
• Expressly require each member of the virtual group (including each NPI under each TIN) to agree to participate in MIPS as a virtual group and comply with the requirements of the MIPS and all other applicable laws and regulations (including, but not limited to, federal criminal law, False Claims Act, anti-kickback statute, civil monetary penalties law, the Health Insurance Portability and Accountability Act of 1996, and physician self-referral law) (at § 414.1315(c)(3)(iii)).
• Require each TIN within a virtual group to notify all NPIs associated with the TIN of their participation in the MIPS as a virtual group (at § 414.1315(c)(3)(iv)).
• Set forth the NPI's rights and obligations in, and representation by, the virtual group, including without limitation, the reporting requirements and how participation in MIPS as a virtual group affects the ability of the NPI to participate in the MIPS outside of the virtual group (at § 414.1315(c)(3)(v)).
• Describe how the opportunity to receive payment adjustments will encourage each member of the virtual group (including each NPI under each TIN) to adhere to quality assurance and improvement (at § 414.1315(c)(3)(vi)).
• Require each member of the virtual group to update its Medicare enrollment information, including the addition and deletion of NPIs billing through a TIN that is part of a virtual group, on a timely basis in accordance with Medicare program requirements and to notify the virtual group of any such changes within 30 days after the change (at § 414.1315(c)(3)(vii)).
• Be for a term of at least one performance period as specified in the formal written agreement (at § 414.1315(c)(3)(viii)).
• Require completion of a close-out process upon termination or expiration of the agreement that requires the TIN (group part of the virtual group) or NPI (solo practitioner part of the virtual group) to furnish, in accordance with applicable privacy and security laws, all data necessary in order for the virtual group to aggregate its data across the virtual group (at § 414.1315(c)(3)(ix)).
On August 18, 2017, we published a 30-day
We want to ensure that all eligible clinicians who bill through the TINs that are components of a virtual group are aware of their participation in a virtual group. We want to implement an approach that considers a balance between the need to ensure that all eligible clinicians in a group are aware of their participation in a virtual group and the minimization of administration burden.
We solicited public comment on these proposals and on approaches for virtual groups to ensure that all eligible clinicians in a group are aware of their participation in a virtual group.
The following is a summary of the public comments received regarding our proposal to require formal written agreement between each member of a virtual group.
We recognize that our proposals regarding virtual group agreements as well as other virtual group matters used the term “member of a virtual group” inconsistently. In some places, we used the term to refer only to the components of the virtual group (that is, the solo practitioners and groups that can form a virtual group), while in other places we used the term to mean both the components of the virtual group and the eligible clinicians billing through a TIN that is a component of the virtual group. We believe that some of the perceived burden of the requirement for a virtual group agreement was due to the ambiguous use of this terminology. Wherever possible, we modified our proposals to ensure that they appropriately distinguishes between the components of a virtual group and the eligible clinicians billing through a TIN that is a component of a virtual group.
We recognize that including virtual group agreement provisions as an addendum to an existing contract may reduce administrative burden and in certain circumstances such an addendum can be incorporated to an existing contract. However, we do believe it is critical that the inclusion of such provisions as an addendum does not limit or restrict the responsibility of each party to collectively meet the program requirements under MIPS. We reiterate that the statute requires formal written agreements to between each solo practitioner and group forming the virtual group. Individuals billing under the TIN of a party to a virtual group are collectively assessed and scored across each performance category based on applicable measures and activities that pertain to the performance of all TINs and NPIs within a virtual group. Each TIN and NPI within a virtual group has an integral role in improving quality of care and health outcomes, and increasing care coordination. As such, we believe it is appropriate to require agreements to only be between solo practitioners and groups and not include third parties. However, we note that virtual groups are not precluded from utilizing, or executing separate agreements with, third parties to provide support for virtual group implementation.
Also, we note that different TINs, particularly small practices, may have access to different resources, which makes it difficult to identify specific requirements pertaining to the inclusion of administration and operationalization of health IT components in a virtual group agreement that would be universally applicable to any virtual group composition, while maintaining the flexibility and discretion afforded to virtual groups in establishing additional elements for their agreements that meet the needs of virtual groups. We recognize that each TIN within a virtual group will need to coordinate within the virtual group to address issues pertaining to interoperability, data collection, measure specifications, workflows, resources, and other related items, and believe that a virtual group is the most appropriate entity to determine how it will prepare, implement, and execute the functions of the virtual group to meet the requirements for each performance category. We believe that our proposed agreement elements provide a critical foundation for virtual group implementation, which establishes a clear responsibility and obligation of each NPI to the virtual group for the duration of an applicable performance period.
We recognize that the election period, including the timeframe virtual groups would have to establish and implement the virtual group agreement, and the timeline for establishing virtual group policies in this final rule with comment period is short and imposes certain potential barriers for virtual group formation and limitations for the first year of virtual group implementation that we are not able to eliminate due to statutory constraints, such as the requirement for virtual groups to make an election made prior to an applicable performance period. In order to mitigate some of the challenges, we developed a model agreement to serve as a template that could be utilized by virtual groups as they prepare for the implementation of virtual groups and are finalizing a modification to the election period deadline by extending it to December 31, which can be accessed on the CMS Web site at
Many commenters expressed concerns regarding the lack of information and clarity pertaining to the interaction between virtual groups and the physician self-referral law, anti-kickback statute, and antitrust law. The commenters requested that CMS clarify the program integrity obligations of virtual groups, issue safe harbors, and publish guidance outlining how the physician self-referral law, anti-kickback statute, and antitrust law apply to virtual groups. The commenters asserted that this was needed in order for solo practitioners and groups to maintain safeguards against fraud and abuse while soliciting partners to form a virtual group and working toward common MIPS goals.
• Identifies the parties to the agreement by name of party, TIN, and NPI, and includes as parties to the agreement only the groups and solo practitioners that compose the virtual group (at § 414.1315(c)(3)(i)).
• Is executed on behalf of each party by an individual who is authorized to bind the party (at § 414.1315(c)(3)(ii)).
• Expressly requires each member of the virtual group (and each NPI under each TIN in the virtual group) to participate in MIPS as a virtual group and comply with the requirements of the MIPS and all other applicable laws and regulations (including, but not limited to, federal criminal law, False Claims Act, anti-kickback statute, civil monetary penalties law, the Health Insurance Portability and Accountability Act of 1996, and physician self-referral law) (at § 414.1315(c)(3)(iii)).
• Identifies each NPI under each TIN in the virtual group and requires each TIN within a virtual group to notify all NPIs associated with the TIN of their participation in the MIPS as a virtual group (at § 414.1315(c)(3)(iv)).
• Sets forth the NPI's rights and obligations in, and representation by, the virtual group, including without limitation, the reporting requirements and how participation in MIPS as a virtual group affects the ability of the NPI to participate in the MIPS outside of the virtual group (at § 414.1315(c)(3)(v)).
• Describes how the opportunity to receive payment adjustments will encourage each member of the virtual group (and each NPI under each TIN in the virtual group) to adhere to quality assurance and improvement (at § 414.1315(c)(3)(vi)).
• Requires each party to the agreement to update its Medicare enrollment information, including the addition and deletion of NPIs billing through its TIN, on a timely basis in accordance with Medicare program requirements and to notify the virtual group of any such changes within 30 days after the change (at § 414.1315(c)(3)(vii)).
• Is for a term of at least one performance period as specified in the formal written agreement (at § 414.1315(c)(3)(viii)).
• Requires completion of a close-out process upon termination or expiration of the agreement that requires each party to the virtual group agreement to furnish, in accordance with applicable privacy and security laws, all data necessary in order for the virtual group to aggregate its data across the virtual group (at § 414.1315(c)(3)(ix)).
During the election process and submission of a virtual group election, a designated virtual group representative will be required to confirm through acknowledgement that an agreement is in place between all solo practitioners and groups that compose the virtual group. An agreement will be executed for at least one performance period. If a NPI joins or leaves a TIN, or a change is made to a TIN that impacts the agreement itself, such as a legal business name change, during the applicable performance period, a virtual group will be required to update the agreement to reflect such changes and submit changes to CMS via the Quality Payment Program Service Center.
As discussed in section II.C.4.d. of this final rule with comment period, we believe virtual groups should generally be treated under the MIPS as groups. Therefore, for MIPS eligible clinicians participating at the virtual group level, we proposed at § 414.1315(d) the following requirements (82 FR 30033):
• Individual eligible clinicians and individual MIPS eligible clinicians who are part of a TIN participating in MIPS at the virtual group level would have their performance assessed as a virtual group (at § 414.1315(d)(1)).
• Individual eligible clinicians and individual MIPS eligible clinicians who are part of a TIN participating in MIPS at the virtual group level would need to meet the definition of a virtual group at all times during the performance period for the MIPS payment year (at § 414.1315(d)(2)).
• Individual eligible clinicians and individual MIPS eligible clinicians who are part of a TIN participating in MIPS at the virtual group level must aggregate their performance data across multiple TINs in order for their performance to be assessed as a virtual group (at § 414.1315(d)(3)).
• MIPS eligible clinicians that elect to participate in MIPS at the virtual group level would have their performance assessed at the virtual group level across all four MIPS performance categories (at § 414.1315(d)(4)).
• Virtual groups would need to adhere to an election process established and required by CMS (at § 414.1315(d)(5)).
The following is a summary of the public comments received regarding our proposed virtual group reporting requirements.
We note that the measure reporting requirements applicable to groups are also generally applicable to virtual groups. However, we note that the requirements for calculating measures and activities when reporting via QCDRs, qualified registries, EHRs, and attestation differ in their application to virtual groups. Specifically, these requirements apply cumulatively across all TINs in a virtual group. Thus, virtual groups will aggregate data for each NPI under each TIN within the virtual group by adding together the numerators and denominators and then cumulatively collate to report one measure ratio at the virtual group level. Moreover, if each MIPS eligible clinician within a virtual group faces a significant hardship or has EHR technology that has been decertified, the virtual group can apply for an exception to have its advancing care information performance category reweighted. If such exception application is approved, the virtual group's advancing care information performance category is reweighted to zero percent and applied to the quality performance category increasing the quality performance weight from 50 percent to 75 percent.
Additionally, the data submission criteria applicable to groups are also generally applicable to virtual groups. However, we note that data completeness and sampling requirements for the CMS Web Interface and CAHPS for MIPS survey differ in their application to virtual groups. Specifically, data completeness for virtual groups applies cumulatively across all TINs in a virtual group. Thus, we note that there may be a case when a virtual group has one TIN that falls below the 60 percent data completeness threshold, which is an acceptable case as long as the virtual group cumulatively exceeds such threshold. In regard to the CMS Web Interface and CAHPS for MIPS survey, sampling requirements pertain to Medicare Part B patients with respect to all TINs in a virtual group, where the sampling methodology would be conducted for each TIN within the virtual group and then cumulatively aggregated across the virtual group. A virtual group would need to meet the beneficiary sampling threshold cumulatively as a virtual group.
Additionally, the data submission criteria applicable to groups are also generally applicable to virtual groups. However, we note that data completeness and sampling requirements for the CMS Web Interface and CAHPS for MIPS survey differ in their application to virtual groups. Specifically, data completeness for virtual groups applies cumulatively across all TINs in a virtual group. Thus, we note that there may be a case when a virtual group has one TIN that falls below the 60 percent data completeness threshold, which is an acceptable case as long as the virtual group cumulatively exceeds such threshold. In regard to the CMS Web Interface and CAHPS for MIPS survey, sampling requirements pertain to Medicare Part B patients with respect to all TINs in a virtual group, where the sampling methodology would be conducted for
In regard to the suggestion provided by the commenter regarding the delay of the implementation of virtual groups, we are not able to further postpone the implementation of virtual groups. We recognize that there are various elements and factors that virtual groups would need to address prior to the execution of virtual groups. Also, we recognize that certain solo practitioners and groups may not be ready to form virtual groups for the 2018 performance period.
We note that the measure reporting requirements applicable to groups are also generally applicable to virtual groups. However, we note that the requirements for calculating measures and activities when reporting via QCDRs, qualified registries, EHRs, and attestation differ in their application to virtual groups. Specifically, these requirements apply cumulatively across all TINs in a virtual group. Thus, virtual groups will aggregate data for each NPI under each TIN within the virtual group by adding together the numerators and denominators and then cumulatively collate to report one measure ratio at the virtual group level. Moreover, if each MIPS eligible clinician within a virtual group faces a significant hardship or has EHR technology that has been decertified, the virtual group can apply for an exception to have its advancing care information performance category reweighted. If such exception application is approved, the virtual group's advancing care information performance category is reweighted to zero percent and applied to the quality performance category increasing the quality performance weight from 50 percent to 75 percent.
Additionally, the data submission criteria applicable to groups are also generally applicable to virtual groups. However, we note that data completeness and sampling requirements for the CMS Web Interface and CAHPS for MIPS survey differ in their application to virtual groups. Specifically, data completeness for virtual groups applies cumulatively across all TINs in a virtual group. Thus, we note that there may be a case when a virtual group has one TIN that falls below the 60 percent data completeness threshold, which is an acceptable case as long as the virtual group cumulatively exceeds such threshold. In regard to the CMS Web Interface and CAHPS for MIPS survey, sampling requirements pertain to Medicare Part B patients with respect to all TINs in a virtual group, where the sampling methodology would be conducted for each TIN within the virtual group and then cumulatively aggregated across the virtual group. A virtual group would need to meet the beneficiary sampling threshold cumulatively as a virtual group.
• Individual eligible clinicians and individual MIPS eligible clinicians who are part of a TIN participating in MIPS at the virtual group level will have their performance assessed as a virtual group at § 414.1315(d)(1).
• Individual eligible clinicians and individual MIPS eligible clinicians who are part of a TIN participating in MIPS at the virtual group level will need to meet the definition of a virtual group at all times during the performance period for the MIPS payment year (at § 414.1315(d)(2)).
• Individual eligible clinicians and individual MIPS eligible clinicians who are part of a TIN participating in MIPS at the virtual group level must aggregate their performance data across multiple TINs in order for their performance to be assessed as a virtual group (at § 414.1315(d)(3)).
• MIPS eligible clinicians that elect to participate in MIPS at the virtual group level will have their performance assessed at the virtual group level across all four MIPS performance categories (at § 414.1315(d)(4)).
• Virtual groups will need to adhere to an election process established and required by CMS (at § 414.1315(d)(5)).
As noted in section II.C.4.a. of this final rule with comment period, section 1848(q)(5)(I)(i) of the Act provides that MIPS eligible clinicians electing to be a virtual group must: (1) Have their performance assessed for the quality and cost performance categories in a manner that applies the combined performance of all the MIPS eligible clinicians in the virtual group to each MIPS eligible clinician in the virtual group for the applicable performance period; and (2) be scored for the quality and cost performance categories based on such assessment for the applicable performance period. We believe it is critical for virtual groups to be assessed and scored at the virtual group level for all performance categories, as it eliminates the burden of virtual group components having to report as a virtual group and separately outside of a virtual group. Additionally, we believe that the assessment and scoring at the virtual group level provides for a comprehensive measurement of performance, shared responsibility, and an opportunity to effectively and efficiently coordinate resources to also achieve performance under the improvement activities and the advancing care information performance categories. Therefore, we proposed at § 414.1315(d)(4) that virtual groups would be assessed and scored across all four MIPS performance categories at the virtual group level for a performance period for a year (82 FR 30033 through 30034).
In the CY 2017 Quality Payment Program final rule (81 FR 77319 through 77329), we established the MIPS final score methodology at § 414.1380, which would apply to virtual groups. We refer readers to sections II.C.4.h. and II.C.6.g. of this final rule with comment period for scoring policies that would apply to virtual groups.
As noted in section II.C.4.g. of this final rule with comment period, we proposed to allow solo practitioners and groups with 10 or fewer eligible clinicians that have elected to be part of a virtual group to have their performance measured and aggregated at the virtual group level across all four performance categories; however, we would apply payment adjustments at the individual TIN/NPI level. Each TIN/NPI would receive a final score based on the virtual group performance, but the payment adjustment would still be applied at the TIN/NPI level. We would assign the virtual group score to all TIN/NPIs billing under a TIN in the virtual group during the performance period.
During the performance period, we recognized that NPIs in a TIN that has joined a virtual group may also be participants in an APM. The TIN, as part of the virtual group, would be required to submit performance data for all eligible clinicians associated with the TIN, including those participating in APMs, to ensure that all eligible clinicians associated with the TIN are being measured under MIPS.
APMs seek to deliver better care at lower cost and to test new ways of paying for care and measuring and assessing performance. In the CY 2017 Quality Payment Program final rule, we established policies to the address concerns we have expressed in regard to the application of certain MIPS policies to MIPS eligible clinicians in MIPS APMs (81 FR 77246 through 77269). In the CY 2018 Quality Payment Program proposed rule, we reiterated those concerns and proposed additional policies for the APM scoring standard (82 FR 30080 through 30091). We believe it is important to consistently apply the APM scoring standard under MIPS for eligible clinicians participating in MIPS APMs in order to avoid potential misalignments between the evaluation of performance under the terms of the MIPS APM and evaluation of performance on measures and activities under MIPS, and to preserve the integrity of the initiatives we are testing. Therefore, we believe it is necessary to waive the requirement to only use the virtual group scores under section 1848(q)(5)(I)(i)(II) of the Act, and instead to apply the score under the APM scoring standard for eligible clinicians in virtual groups who are also in an APM Entity participating in an APM.
Specifically, for participants in MIPS APMs, we proposed to use our authority under section 1115A(d)(1) of the Act for MIPS APMs authorized under section 1115A of the Act, and under section 1899(f) of the Act for the Shared Savings Program, to waive the requirement under section 1848(q)(2)(5)(I)(i)(II) of the Act that requires performance category scores from virtual group reporting to be used to generate the final score upon which the MIPS payment adjustment is based for all TIN/NPIs in the virtual group. Instead, we would use the score assigned to the MIPS eligible clinician based on the applicable APM Entity score to determine MIPS payment adjustments for all MIPS eligible clinicians that are part of an APM Entity participating in a MIPS APM, in accordance with § 414.1370, instead of determining MIPS payment adjustments for these MIPS eligible clinicians using the final score of their virtual group.
We noted that MIPS eligible clinicians who are participants in both a virtual group and a MIPS APM would be assessed under MIPS as part of the virtual group and under the APM scoring standard as part of an APM Entity group, but would receive their payment adjustment based only on the APM Entity score. In the case of an eligible clinician participating in both a virtual group and an Advanced APM who has achieved QP status, the clinician would be assessed under MIPS as part of the virtual group, but would still be excluded from the MIPS payment adjustment as a result of his or her QP status. We refer readers to section II.C.6.g. of this final rule with comment period for further discussion regarding the waiver.
The following is a summary of the public comments received regarding our proposals.
For the 2018 performance period, virtual groups submitting data on quality measures using QCDRs, qualified registries, or via EHR must report on at least 60 percent of the virtual group's patients that meet the measure's denominator criteria, regardless of payer for the performance period. We expect to receive quality data for both Medicare and non-Medicare patients under these submission mechanisms. Virtual 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 note that the measure reporting requirements applicable to groups are also generally applicable to virtual groups. However, we note that the requirements for calculating measures and activities when reporting via QCDRs, qualified registries, EHRs, and attestation differ in their application to virtual groups. Specifically, these requirements apply cumulatively across all TINs in a virtual group. Thus, virtual groups will aggregate data for each NPI under each TIN within the virtual group by adding together the numerators and denominators and then cumulatively collate to report one measure ratio at the virtual group level. Moreover, if each MIPS eligible clinician within a virtual group faces a significant hardship or has EHR technology that has been decertified, the virtual group can apply for an exception to have its advancing care information performance category reweighted. If such exception application is approved, the virtual group's advancing care information performance category is reweighted to zero percent and applied to the quality performance category increasing the quality performance weight from 50 percent to 75 percent.
Additionally, the data submission criteria applicable to groups are also generally applicable to virtual groups. However, we note that data completeness and sampling requirements for the CMS Web Interface and CAHPS for MIPS survey differ in their application to virtual groups. Specifically, data completeness for virtual groups applies cumulatively across all TINs in a virtual group. Thus, we note that there may be a case when a virtual group has one TIN that falls below the 60 percent data completeness threshold, which is an acceptable case as long as the virtual group cumulatively exceeds such threshold. In regard to the CMS Web Interface and CAHPS for MIPS survey, sampling requirements pertain to Medicare Part B patients with respect to all TINs in a virtual group, where the sampling methodology would be conducted for each TIN within the virtual group and then cumulatively aggregated across the virtual group. A virtual group would need to meet the beneficiary sampling threshold cumulatively as a virtual group.
In regard to performance under the improvement activities performance category, we clarified in the CY 2017 Quality Payment Program final rule (81 FR 77181) that if one MIPS eligible clinician (NPI) in a group completed an improvement activity, the entire group (TIN) would receive credit for that activity. In addition, we specified that all MIPS eligible clinicians reporting as a group would receive the same score for the improvement activities performance category if at least one clinician within the group is performing the activity for a continuous 90 days in the performance period. As discussed in section II.C.4.d. of this final rule with comment period, we are finalizing our proposal to generally apply our previously finalized and proposed group policies to virtual groups, unless otherwise specified. Thus, if one MIPS eligible clinician (NPI) in a virtual group completed an improvement activity, the entire virtual group would receive credit for that activity and receive the same score for the improvement activities performance category if at least one clinician within the virtual group is performing the activity for a minimum of a continuous 90-day period in CY 2018. In order for virtual groups to achieve full credit under the improvement activities performance category for the 2018 performance period, they would need to submit four medium-weighted or two high-weighted activities that were for a minimum of a continuous 90-day period in CY 2018. Virtual groups that are considered to be non-patient facing or small practices, or designated as rural or HPSA practices will receive full credit by submitting one high-weighted improvement activity or two medium-weighted improvement activities that were conducted for a minimum of a continuous 90-day period in CY 2018.
In regard to compliance with quality and improvement activities performance category requirements, virtual groups would meet the same performance category requirements applicable to groups. In section II.C.4.g. of this final rule with comment period, we outline virtual group reporting requirements. Virtual groups are required to adhere to the requirements established for each performance category. Performance data submitted to CMS on behalf of virtual groups must be meet form and manner requirements for each submission mechanism.
For participants in MIPS APMs, we will use our authority under section 1115A(d)(1) for MIPS APM authorized under section 1115A of the Act, and under section 1899(f) for the Shared Savings Program, to waive the requirement under section 1848 (q)(2)(5)(I)(i)(II) of the Act that requires performance category scores from virtual group reporting to be used to generate the final score upon which the MIPS payment adjustment is based for all TIN/NPIs in the virtual group. We will use the score assigned to the MIPS eligible clinician based on the applicable APM Entity score to determine MIPS payment adjustments for all MIPS eligible clinicians that are part of an APM Entity participating in a MIPS APM, in accordance with § 414.1370, instead of determining MIPS payment adjustments for these MIPS eligible clinicians using the final score of their virtual group.
In the CY 2017 Quality Payment Program final rule (81 FR 77085), we finalized 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). We finalized 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 did not propose any changes to these policies.
We also finalized at § 414.1325(f)(2) that 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. In this final rule with comment period, we are finalizing three policies (small practice size determination, non-patient facing determination, and low-volume threshold determination) that utilize a 30-day claims run out. We refer readers to sections II.C.l.c., II.C.l.e., and II.C.2.c. of this final rule with comment period for details on these three policies. Lastly, we finalized that individual MIPS eligible clinicians or groups who report less than 12 months of data (due to family leave, etc.) are required to report all performance data available from the applicable performance period (for example, CY 2018 or a minimum of a continuous 90-day period within CY 2018).
We proposed at § 414.1320(c)(1) that for purposes of the 2021 MIPS payment year and future years, the performance period for the quality and cost performance categories would be the full calendar year (January 1 through December 31) that occurs 2 years prior to the applicable payment year. For example, for the 2021 MIPS payment year, the performance period would be CY 2019 (January 1, 2019 through December 31, 2019), and for the 2022 MIPS payment year, the performance period would be CY 2020 (January 1, 2020 through December 31, 2020).
We proposed at § 414.1320(d)(1) that for purposes of the 2021 MIPS payment year, the performance period for the improvement activities and advancing care information performance categories would be a minimum of a continuous 90-day period within CY 2019, up to and including the full CY 2019 (January 1, 2019 through December 31, 2019).
The following is a summary of the public comments received on the “MIPS Performance Period” proposals and our responses:
We finalized in the CY 2017 Quality Payment Program final rule (81 FR 77094) at § 414.1325(a) that individual MIPS eligible clinicians and groups must submit measures and activities, as applicable, for the quality, improvement activities, and advancing care information performance categories. For the cost performance category, we finalized 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 are not required to submit any additional information for the cost performance category. We finalized in the CY 2017 Quality Payment Program final rule (81 FR 77094 through 77095) multiple data submission mechanisms for MIPS, which provide individual MIPS eligible clinicians and groups with the flexibility to submit their MIPS measures and activities in a manner that best accommodates the characteristics of their practice, as indicated in Tables 2 and 3. Table 2 summarizes the data submission mechanisms for individual MIPS eligible clinicians that we finalized at § 414.1325(b) and (e). Table 3 summarizes the data submission mechanisms for groups that are not reporting through an APM that we finalized at § 414.1325(c) and (e).
We
We proposed to revise § 414.1325(d) for purposes of the 2020 MIPS payment year and future years, beginning with performance periods occurring in 2018, to allow individual MIPS eligible clinicians and groups to submit data on measures and activities, as applicable and available, via multiple data submission mechanisms for a single performance category (specifically, the quality, improvement activities, or advancing care information performance category) (82 FR 30035). Under this proposal, individual MIPS eligible clinicians and groups that have fewer than the required number of measures and activities applicable and available under one submission mechanism could submit data on additional measures and activities via one or more additional submission mechanisms, as necessary, to receive a potential maximum number of points under a performance category.
If an individual MIPS eligible clinician or group submits the same measure through two different mechanisms, each submission would be calculated and scored separately. We do not have the ability to aggregate data on the same measure across submission mechanisms. We would only count the submission that gives the clinician the higher score, thereby avoiding the double count. We refer readers to section II.C.7.a.(2) of this final rule with comment period, which further outlines how we proposed to score measures and activities regardless of submission mechanism.
We believe that this flexible approach would help individual MIPS eligible clinicians and groups with reporting, as it provides more options for the submission of data for the applicable performance categories. We believe that by providing this flexibility, we would be allowing MIPS eligible clinicians to choose the measures and activities that are most meaningful to them, regardless of the submission mechanism. We are aware that this proposal for increased flexibility in data submission mechanisms may increase complexity and in some instances necessitate additional costs for clinicians, as they may need to establish relationships with additional data submission mechanism vendors in order to report additional measures and/or activities for any given performance category. We clarified that the requirements for the performance categories remain the same, regardless of the number of submission mechanisms used. It is also important to note that for the improvement activities and advancing care information performance categories, that using multiple data submission mechanisms may limit our ability to provide real-time feedback. While we strive to provide flexibility to individual MIPS eligible clinicians and groups, we noted that our goal within the MIPS program is to minimize complexity and administrative burden to individual MIPS eligible clinicians and groups.
As discussed in section II.C.4 of this final rule with comment period, we proposed to generally apply our previously finalized and proposed group policies to virtual groups. With respect to data submission mechanisms, we proposed that virtual groups would be able to use a different submission mechanism for each performance category, and would be able to utilize multiple submission mechanisms for the quality performance category, beginning with performance periods occurring in 2018 (82 FR 30036). However, virtual groups would be required to utilize the same submission mechanism for the improvement activities and the advancing care information performance categories.
For those MIPS eligible clinicians participating in a MIPS APM, who are on an APM Participant List on at least one of the three snapshot dates as finalized in the CY 2017 Quality Payment Program Final Rule (81 FR 77444 through 77445), or for MIPS eligible clinicians participating in a full TIN MIPS APM, who are on an APM Participant List on at least one of the four snapshot dates as discussed in section II.C.6.g.(2) of this final rule with comment period, the APM scoring standard applies. We refer readers to § 414.1370 and the CY 2017 Quality Payment Program final rule (81 FR 77246), which describes how MIPS eligible clinicians participating in APM entities submit data to MIPS in the form and manner required, including separate approaches to the quality and cost performance categories applicable to MIPS APMs. We did not propose any changes to how APM entities in MIPS APMs and their participating MIPS eligible clinicians submit data to MIPS.
The following is a summary of the public comments received on the “Performance Category Measures and Reporting: Submission Mechanisms” proposal and our responses:
We are finalizing our proposal with modification. Specifically, we are not finalizing our proposal for the CY 2018 performance period, and our previously finalized policies continue to apply for the CY 2018 performance period. Thus, for the CY 2018 performance period, virtual groups may elect to submit information via multiple submission mechanisms; however, they must use the same identifier for all practice categories, and they may only use one submission mechanism per performance
In the CY 2017 Quality Payment Program final rule (81 FR 77097), we finalized submission deadlines by which all associated data for all performance categories must be submitted for the submission mechanisms described in this rule.
As specified at § 414.1325(f)(1), the data submission deadline for the qualified registry, QCDR, EHR, and attestation submission mechanisms is 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 performance periods occurring in 2018, the data submission period will occur prior to January 2, 2019, if technically feasible, through March 31, 2019. 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, 2019.
At § 414.1325(f)(2), we specified that for the Medicare Part B claims submission mechanism, 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. Lastly, for the CMS Web Interface submission mechanism, at § 414.1325(f)(3), we specified that the data must be submitted during an 8-week period following the close of the performance period that will begin no earlier than January 2, 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 did not propose any changes to the submission deadlines in the CY 2018 Quality Payment Program proposed rule.
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.
As discussed in the CY 2017 Quality Payment Program final rule (81 FR 77098 through 77099), we finalized 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 comments we received in response to the CY 2017 Quality Payment Program proposed rule and the MIPS and APMs RFI.
• To encourage meaningful measurement, we finalized allowing individual MIPS eligible clinicians and groups the flexibility to determine the most meaningful measures and data submission mechanisms for their practice.
• To simplify the reporting criteria, we aligned the submission criteria for several of the data submission mechanisms.
• To reduce administrative burden and focus on measures that matter, we lowered the required number of the measures for several of the data submission mechanisms, yet still required that certain types of measures, particularly outcome measures, be reported.
• To create alignment with other payers and reduce burden on MIPS eligible clinicians, we incorporated measures that align with other national payers.
• To create a more comprehensive picture of a practice's performance, we also finalized the use of all-payer data where possible.
As beneficiary health is always our top priority, we finalized criteria to continue encouraging the reporting of certain measures such as outcome, appropriate use, patient safety, efficiency, care coordination, or patient experience measures. However, as discussed in the CY 2017 Quality Payment Program final rule (81 FR 77098), we removed the requirement for measures to span across multiple domains of the NQS. While we do not require that MIPS eligible clinicians select measures across multiple domains, we encourage them to do so.
For MIPS payment year 2019, the quality performance category will account for 60 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 that 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 final score shall be based on 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 the cost performance category.
In the CY 2017 Quality Payment Program final rule (81 FR 77100), we finalized at § 414.1330(b) that, for MIPS payment years 2019 and 2020, 60 percent and 50 percent, respectively, of
As discussed in section II.C.6.d. of this final rule with comment period, we are not finalizing our proposal to weight the cost performance category at zero percent for the second MIPS payment year (2020) and are instead retaining the previously finalized cost performance category weight of 10 percent for that year. In accordance with section 1848(q)(5)(E)(i)(I)(bb) of the Act, for the first 2 years, the percentage of the MIPS final score that would otherwise be based on the quality performance category (that is, 30 percent) must be increased by the same number of percentage points by which the percentage based on the cost performance category is less than 30 percent. We proposed to modify § 414.1330(b)(2) to reweight the percentage of the MIPS final score based on the quality performance category for MIPS payment year 2020 as may be necessary to account for any reweighting of the cost performance category, if finalized (82 FR 30037). Thus, since we are not finalizing our proposal to reweight the cost performance category to zero percent for MIPS payment year 2020, we are not finalizing our proposal to modify § 414.1330(b)(2), as the performance in the quality performance category currently comprises 50 percent of a MIPS eligible clinician's final score for MIPS payment year 2020, and no reweighting is necessary to account for the previously finalized cost performance category weight. We refer readers to section II.C.6.d. of this final rule with comment period for more information on the cost 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 finalized scoring policies, an individual MIPS eligible clinician or group that reports on all required measures and activities could potentially obtain the highest score possible within the performance category, assuming they perform well on the measures and activities they report. An individual MIPS eligible clinician or group who does not submit data on a required measure or activity would receive a zero score for the unreported items in the performance category (in accordance with section 1848(q)(5)(B)(i) of the Act). The individual 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 individual MIPS eligible clinician or group from obtaining the highest possible score within the performance category.
The following is a summary of the public comments received on the “Contribution to Final Score” proposal and our responses:
In the CY 2017 Quality Payment Program final rule (81 FR 77114), we finalized at § 414.1335(a)(1) that individual MIPS eligible clinicians submitting data via claims and individual MIPS eligible clinicians and groups submitting data via all mechanisms (excluding the CMS Web Interface and the CAHPS for MIPS survey) are required to meet the following submission criteria. For the applicable period during the performance period, the individual 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 individual 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 individual MIPS eligible clinician or group would be required to report on each measure that is applicable. We defined “applicable” to mean measures relevant to a particular MIPS eligible clinician's services or care rendered. As discussed in section II.C.7.a.(2) of this final rule with comment period, we will only make determinations as to whether a sufficient number of measures are applicable for claims-based and registry submission mechanisms; we will not make this determination for EHR and QCDR submission mechanisms, for example.
Alternatively, the individual MIPS eligible clinician or group will report one specialty 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, the MIPS eligible clinician will 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 measure set and will not be penalized for doing so, provided that such MIPS eligible clinicians follow all requirements discussed here.
In accordance with § 414.1335(a)(1)(ii), individual MIPS eligible clinicians and groups will select their measures from either the set of all MIPS measures listed or referenced in Table A of the Appendix in this final rule with comment period or one of the specialty measure sets listed in Table B of the Appendix in this final rule with comment period. We note that some specialty measure sets include measures grouped by subspecialty; in these cases, the measure set is defined at the subspecialty level. Previously finalized quality measures may be found in the CY 2017 Quality Payment Program final rule (81 FR 77558 through 77816).
We also finalized the definition of a high priority measure at § 414.1305 to mean an outcome, appropriate use, patient safety, efficiency, patient experience, or care coordination quality measure. Except as discussed in section II.C.6.b.(3)(a) of this final rule with comment period with regard to the CMS Web Interface and the CAHPS for MIPS survey, we did not propose any changes to the submission criteria or definitions established for measures in the proposed rule.
In the CY 2017 Quality Payment Program final rule (81 FR 77114), we solicited comments regarding adding a requirement to our finalized policy 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 the Quality Payment Program Year 2 and future years. For clarification, we consider a cross-cutting measure to be any measure that is broadly applicable across multiple clinical settings and individual MIPS eligible clinicians or groups within a variety of specialties. We specifically requested 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 refer readers to the CY 2018 Quality Payment Program proposed rule (82 FR 30038 through 30039) for a full discussion of the comments received and responses provided.
Except as discussed in section II.C.6.b.(3)(a)(iii) of this final rule with comment period with regard to the CAHPS for MIPS survey, we did not propose any changes to the submission criteria for quality measures. We solicited additional feedback on meaningful ways to incorporate cross-cutting measurement into MIPS and the Quality Payment Program generally. We received several comments regarding incorporating cross-cutting measurements into the Quality Payment Program and will take them into consideration in future rulemaking.
In the CY 2017 Quality Payment Program final rule (81 FR 77116), we finalized at § 414.1335(a)(2) the following criteria for the submission of data on quality measures by registered groups of 25 or more eligible clinicians
In the CY 2017 Quality Payment Program final rule (81 FR 77116), we finalized to continue to align the 2019 CMS Web Interface beneficiary assignment methodology with the attribution methodology for two of the measures that were formerly in the VM: the acute and chronic composite measures of Agency for Healthcare Research and Quality (AHRQ) Prevention Quality Indicators (PQIs) discussed in the CY 2017 Quality Payment Program proposed rule (81 FR 28192) and total per capita cost for all attributed beneficiaries discussed in the CY 2017 Quality Payment Program proposed rule (81 FR 28196). When establishing MIPS, we also finalized a modified 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 CY 2017 Quality Payment Program proposed rule (81 FR 28196).
We clarify that the attribution methodology for the CMS Web Interface implemented under MIPS is similar to the attribution methodology implemented under the Physician Quality Reporting System (PQRS) Group Practice Reporting Option (GPRO) Web Interface, which utilizes a two-step attribution process to associate beneficiaries with TINs during the period in which performance is assessed. The process attributes a beneficiary to a TIN that bills the plurality of primary care services for that beneficiary. In order to conduct attribution for the CMS Web Interface, we utilize retrospective assignment to identify beneficiaries eligible for sampling and identify the beneficiary claims that will be utilized for the calculations of cost. Beneficiary assignment for groups is based on a 10-month period (between January and October) and determined retrospectively after the month of October for the applicable performance period. We note that it is not operationally feasible for us to utilize a period longer than 10 months, to assess claims data for beneficiary assignment for a performance period.
Lastly, we note that groups reporting via the CMS Web Interface may also report the CAHPS for MIPS survey and receive bonus points for submitting that measure. We did not propose any changes to the submission criteria for quality measures for groups reporting via the CMS Web Interface in the proposed rule.
The following is a summary of the public comments received on the “Submission Criteria for Quality Measures for Groups Reporting via the CMS Web Interface” proposal and our responses:
In the CY 2017 Quality Payment Program final rule (81 FR 77100), we finalized 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 measure 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 mechanism. A group may report any five measures within MIPS plus the CAHPS for MIPS survey to achieve the six measures threshold. We did not propose any changes to the performance criteria for quality measures for groups electing to report the CAHPS for MIPS survey in the proposed rule.
In the CY 2017 Quality Payment Program final rule (see 81 FR 77120), we finalized retaining the CAHPS for MIPS survey administration period that was utilized for PQRS of November to February. However, this survey administration period has become operationally problematic for the administration of MIPS. In order to compute scoring, we must have the
In addition, as discussed in the CY 2017 Quality Payment Program final rule (81 FR 77116), we anticipated exploring the possibility of updating the CAHPS for MIPS survey under MIPS, specifically not finalizing all of the proposed Summary Survey Measures (SSMs). The CAHPS for MIPS survey currently consists of the core CAHPS Clinician & Group (CG-CAHPS) Survey developed by the Agency for Healthcare Research and Quality (AHRQ), plus additional survey questions to meet CMS's program needs. We proposed for the Quality Payment Program Year 2 and future years to remove two SSMs, specifically, “Helping You to Take Medication as Directed” and “Between Visit Communication” from the CAHPS for MIPS survey (82 FR 30040). We proposed to remove the SSM entitled “Helping You to Take Medication as Directed” due to low reliability. In 2014 and 2015, the majority of groups had very low reliability on this SSM. Furthermore, based on analyses conducted of SSMs in an attempt to improve their reliability, removing questions from this SSM did not result in any improvements in reliability. The SSM, “Helping You to Take Medication as Directed,” has also never been a scored measure with the Medicare Shared Savings Program CAHPS for Accountable Care Organizations (ACOs) Survey. We refer readers to the CY 2014 Physician Fee Schedule final rule for a discussion on the CAHPS for ACOs survey scoring (79 FR 67909 through 67910) and measure tables (79 FR 67916 through 67917). The SSM entitled “Between Visit Communication” currently contains only one question. This question could also be considered related to other SSMs entitled: “Care Coordination” or “Courteous and Helpful Office Staff,” but does not directly overlap with any of the questions under that SSM. However, we proposed to remove this SSM in order to maintain consistency with the Medicare Shared Savings Program which, utilizes the CAHPS for ACOs Survey. The SSM entitled “Between Visit Communication” has never been a scored measure with the Medicare Shared Savings Program CAHPS for ACOs Survey. We refer readers to section II.C.6.g. for the discussion of the CAHPS for ACOs survey.
In addition to public comments we received, we also took into consideration analysis we conducted before finalizing this provision. Specifically, we reviewed the findings of the CAHPS for ACOs survey pilot, which was administered from November 2016 through February 2017. The CAHPS for ACOs survey pilot utilized a survey instrument which did not contain the two SSMs that we proposed for removal from the CAHPS for MIPS survey. For more information on the other SSMs within 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).
We sought comment on expanding the patient experience data available for the CAHPS for MIPS survey (82 FR 30040 through 30401). Currently, the CAHPS for MIPS survey is available for groups to report under the MIPS. The patient experience survey data that is available on Physician Compare is highly valued by patients and their caregivers as they evaluate their health care options. However, in user testing with patients and caregivers in regard to the Physician Compare Web site, the users regularly request more information from patients like them in their own words. Patients regularly request that we include narrative reviews of individual clinicians and groups on the Web site. AHRQ is fielding a beta version of the CAHPS Patient Narrative Elicitation Protocol (
We are requiring, where possible, all-payer data for all reporting mechanisms, yet certain reporting mechanisms are limited to Medicare Part B data. Specifically, the CAHPS for MIPS survey currently relies on sampling protocols based on Medicare Part B billing; therefore, only Medicare Part B beneficiaries are sampled through that methodology. We requested comments on ways to modify the methodology to assign and sample patients using data from other payers for reporting mechanisms that are currently limited to Medicare Part B data (82 FR 30041). In particular, we sought comment on the ability of groups to provide information on the patients to whom they provide care during a calendar year, whether it would be possible to identify a list of patients seen by individual clinicians in the group, and what type of patient contact information groups would be able to provide. Further, we sought comment on the challenges groups may anticipate in trying to provide this type of information, especially for vulnerable beneficiary populations, such as those lacking stable housing. We also sought comment on EHR vendors' ability to provide information on the patients who receive care from their client groups.
The following is a summary of the public comments received on the “Performance Criteria for Quality Measures for Groups Electing to Report the CAHPS for MIPS Survey” proposals and our responses:
In the CY 2017 Quality Payment Program final rule (81 FR 77125), we finalized data completeness criteria for the transition year and MIPS payment year 2020. We finalized at § 414.1340 the data completeness criteria that follows for performance periods occurring in 2017.
• 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 individual 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 that CMS provides.
In addition, we finalized an increased data completeness threshold of 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 noted that we anticipate we will propose to increase these thresholds for data submitted on quality measures using QCDRs, qualified registries, via EHR, or Medicare Part B claims for performance periods occurring in 2019 and onward.
We proposed to modify the previously established data completeness criteria for MIPS payment year 2020 (82 FR 30041 through 30042). Specifically, we proposed to provide an additional year for individual MIPS eligible clinicians and groups to gain experience with MIPS before increasing the data completeness thresholds for data submitted on quality measures using QCDRs, qualified registries, via EHR, or Medicare Part B claims. We noted concerns about the unintended consequences of accelerating the data completeness threshold so quickly, which may jeopardize MIPS eligible clinicians' ability to participate and perform well under the MIPS, particularly those clinicians who are least experienced with MIPS quality measure data submission. We wanted to ensure that an appropriate yet achievable level of data completeness is applied to all MIPS eligible clinicians. We continue to believe it is important to incorporate higher data completeness thresholds in future years to ensure a more accurate assessment of a MIPS eligible clinician's performance on quality measures and to avoid any selection bias. Therefore, we proposed a 60 percent data completeness threshold for MIPS payment year 2021. We strongly encouraged all MIPS eligible clinicians to perform the quality actions associated with the quality measures on their patients. The data submitted for each measure is expected to be representative of the individual MIPS eligible clinician's or group's overall performance for that measure. The data completeness threshold of less than 100 percent is intended to reduce burden and accommodate operational issues that may arise during data collection during the initial years of the program. We provided this notice to MIPS eligible clinicians so that they can take the necessary steps to prepare for higher data completeness thresholds in future years.
Therefore, we proposed to revise the data completeness criteria for the quality performance category at § 414.1340(a)(2) to provide that MIPS eligible clinicians and groups submitting quality measures data using the QCDR, qualified registry, or EHR submission mechanism must submit data on at least 50 percent of the individual MIPS eligible clinician's or group's patients that meet the measure's denominator criteria, regardless of payer, for MIPS payment year 2020. We also proposed to revise the data completeness criteria for the quality performance category at § 414.1340(b)(2) to provide that MIPS eligible clinicians and groups submitting quality measures data using Medicare Part B claims, must submit data on 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 2020. We further proposed at § 414.1340(a)(3), that MIPS eligible clinicians and groups submitting quality measures data using the QCDR, qualified registry, or EHR submission mechanism must submit data on at least 60 percent of the individual MIPS eligible clinician or group's patients that meet the measure's denominator criteria, regardless of payer, for MIPS payment year 2021. We also proposed at § 414.1340(b)(3), that MIPS eligible clinicians and groups submitting quality measures data using Medicare Part B claims, must submit data on 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 2021. We noted that we anticipate for future MIPS payment years we will propose to increase the data completeness threshold for data submitted using QCDRs, qualified registries, EHR submission mechanisms, or Medicare Part B claims. As MIPS eligible clinicians gain experience with the MIPS, we would propose to steadily increase these thresholds for future years through rulemaking. In addition, we sought comment on what data completeness threshold should be established for future years.
In the CY 2017 Quality Payment Program final rule (81 FR 77125 through 77126), we finalized our approach of including all-payer data for the QCDR, qualified registry, and EHR submission mechanisms because we believed this approach provides a more complete picture of each MIPS eligible clinician's
The following is a summary of the public comments received on the “Data Completeness Criteria” proposals and our responses:
• § 414.1340(a)(2) that MIPS eligible clinicians and groups submitting quality measures data using the QCDR, qualified registry, or EHR submission mechanism must submit data on 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; and
• § 414.1340(b)(2) that MIPS eligible clinicians submitting quality measures data using Medicare Part B claims, must submit data on at least 60 percent of the applicable Medicare Part B patients seen during the performance period to which the measure applies for MIPS payment years 2020.
We are, however, finalizing our proposal regarding the data completeness criteria for MIPS payment year 2021. Specifically, we are finalizing at:
• § 414.1340(a)(2) that MIPS eligible clinicians and groups submitting quality measures data using the QCDR, qualified registry, or EHR submission mechanism must submit data on at least 60 percent of the MIPS eligible clinician or group's patients that meet the measure's denominator criteria,
• § 414.1340(b)(2) that MIPS eligible clinicians submitting quality measures data using Medicare Part B claims, must submit data on at least 60 percent of the applicable Medicare Part B patients seen during the performance period to which the measure applies for MIPS payment years 2021.
Table 5 reflects our final quality data submission criteria for MIPS payment years 2020 and 2021 via Medicare Part B claims, QCDR, qualified registry, EHR, CMS Web Interface, and the CAHPS for MIPS survey. It is important to note that while we finalized at § 414.1325(d) in the CY 2017 Quality Payment Program final rule that individual MIPS eligible clinicians and groups may only use one submission mechanism per performance category, in section II.C.6.a.(1) of this final rule with comment period, we are finalizing to revise § 414.1325(d) for purposes of the 2021 MIPS payment year and future years to allow individual MIPS eligible clinicians and groups to submit measures and activities, as applicable, via as many submission mechanisms as necessary to meet the requirements of the quality, improvement activities, or advancing care information performance categories. We refer readers to section II.C.6.a.(1) of this final rule with comment period for further discussion of this policy.
We note that the measure reporting requirements applicable to groups are also generally applicable to virtual groups. However, we note that the requirements for calculating measures and activities when reporting via QCDRs, qualified registries, EHRs, and attestation differ in their application to virtual groups. Specifically, these requirements apply cumulatively across all TINs in a virtual group. Thus, virtual groups will aggregate data for each NPI under each TIN within the virtual group by adding together the numerators and denominators and then cumulatively collate to report one measure ratio at the virtual group level. Moreover, if each MIPS eligible clinician within a virtual group faces a significant hardship or has EHR technology that has been decertified, the virtual group can apply for an exception to have its advancing care information performance category reweighted. If such exception application is approved, the virtual group's advancing care information performance category is reweighted to zero percent and applied to the quality performance category increasing the quality performance weight from 50 percent to 75 percent.
Additionally, the data submission criteria applicable to groups are also generally applicable to virtual groups. However, we note that data completeness and sampling requirements for the CMS Web Interface and CAHPS for MIPS survey differ in their application to virtual groups. Specifically, data completeness for virtual groups applies cumulatively across all TINs in a virtual group. Thus, we note that there may be a case when a virtual group has one TIN that falls below the 60 percent data completeness threshold, which is an acceptable case as long as the virtual group cumulatively exceeds such threshold. In regard to the CMS Web Interface and CAHPS for MIPS survey, sampling requirements pertain to Medicare Part B patients with respect to all TINs in a virtual group, where the sampling methodology would be conducted for
In the CY 2017 Quality Payment Program final rule (81 FR 77127), we finalized at § 414.1335 that non-patient facing MIPS eligible clinicians would be required to meet the applicable submission criteria that apply for all MIPS eligible clinicians for the quality performance category. We did not propose any changes to this policy in the proposed rule.
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. However, the Secretary may not use measures for hospital outpatient departments, except in the case of items and services furnished by emergency physicians, radiologists, and anesthesiologists. We refer readers to section II.C.7.a.(4) of this final rule with comment period for a full discussion of the finalized policies regarding the application of facility-based measures.
In the CY 2017 Quality Payment Program final rule (81 FR 77136), we did not finalize all of our proposals on global and population-based measures as part of the quality score. Specifically, we did not finalize our proposal to use the acute and chronic composite measures of the AHRQ Prevention Quality Indicators (PQIs). We agreed with commenters that additional enhancements, including the addition of risk adjustment, needed to be made to these measures prior to inclusion in MIPS. We did, however, calculate these measures at the TIN level, and provided the measure data through the QRURs released in September 2016, and this data can be used by MIPS eligible clinicians for informational purposes.
We did finalize the all-cause hospital readmissions (ACR) measure from the VM Program as part of the annual list of quality measures for the MIPS quality performance category. We finalized this measure with the following modifications. We did not apply the ACR measure to solo practices or small groups (groups of 15 or less). We did apply the ACR measure to groups of 16 or more who meet the case volume of 200 cases. A group will be scored on the ACR measure even if it did not submit any quality measures, if it submitted in other performance categories. Otherwise, the group will not be scored on the readmission measure if it did not submit data in any of the performance categories. 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, an individual MIPS eligible clinician or group must submit information in one of the three performance categories as discussed in the CY 2017 Quality Payment Program final rule (81 FR 77329). However, for MIPS eligible clinicians who did not meet the minimum case requirements, the ACR measure was not applicable. In the CY 2018 Quality Payment Program proposed rule, we did not propose to remove this measure from the list of quality measures for the MIPS quality performance category. Nor did we propose any changes for the ACR measure in the proposed rule. As discussed in section II.C.4.d. of this final rule with comment period, we are finalizing our proposal to generally apply our finalized group policies to virtual groups.
Under section 1848(q)(2)(D)(i) of the Act, the Secretary, through notice and comment rulemaking, must establish an annual list of MIPS quality measures from which MIPS eligible clinicians may choose for purposes of assessment for a performance period. The annual list of MIPS 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 Under Consideration” 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 MIPS quality measures, as well as updates to the measures. 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 that submit measures for consideration through the call for measures. Any such restriction would limit the type of quality measures and the scope and utility of the quality measures that may be considered for inclusion under the MIPS.
As we described previously in the CY 2017 Quality Payment Program final rule (81 FR 77137), we will accept quality measures submissions at any time, but only measures submitted during the timeframe provided by us through the pre-rulemaking process of each year will be considered for inclusion in the annual list of MIPS quality measures for the performance period beginning 2 years after the measure is submitted. This process is consistent with the pre-rulemaking process and the annual call for measures, which are further described at (
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. The annual Call for Measures process allows eligible clinician organizations and other relevant stakeholder organizations to identify and submit quality measures for consideration. Presumably, stakeholders would not submit
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, 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, with strong encouragement and preference for measures that have completed or are near completion of reliability and validity testing.
• 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 resource use.
• Measures that address significant variation in performance.
We will apply these considerations when considering quality measures for possible inclusion in MIPS.
In addition, we note that we are likely to reject measures that do not provide substantial evidence of variation in performance; for example, if a measure developer submits data showing a small variation in performance among a group already composed of high performers, such evidence would not be substantial enough to assure us that sufficient variation in performance exists. We also noted that we are likely to reject measures that are not outcome-based measures, unless: (1) There is substantial documented and peer reviewed evidence that the clinical process measured varies directly with the outcome of interest; and (2) it is not possible to measure the outcome of interest in a reasonable timeframe.
We also noted that retired measures that were in one of CMS's previous quality programs, such as the Physician Quality Reporting System (PQRS) program, will likely be rejected if proposed for inclusion. This includes measures that were retired due to being topped out, as defined below. For example, measures may be retired due to attaining topped out status because of high performance, or measures that are retired due to a change in the evidence supporting their use.
In the CY 2017 Quality Payment Program final rule (81 FR 77153), we established that we will categorize measures into the six NQS domains (patient safety, person- and caregiver-centered experience and outcomes, communication and care coordination, effective clinical care, community/population health, and efficiency and cost reduction). We intend to submit future MIPS quality measures to the NQF-convened Measure Application Partnership's (MAP), as appropriate, and we intend to consider the MAP's recommendations as part of the comprehensive assessment of each measure considered for inclusion under MIPS.
In the CY 2017 Quality Payment Program final rule (81 FR 77155), we established that we 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. The submission of this information does not preclude us from conducting our own research using Medicare claims data, Medicare survey results, and other data sources that we possess. We submit new measures for publication in applicable specialty-appropriate, peer-reviewed journals before including such measures in the final annual list of quality measures.
In the CY 2017 Quality Payment Program final rule (81 FR 77158), we established at § 414.1330(a)(2) that for purposes of assessing performance of MIPS eligible clinicians in the quality performance category, we use quality measures developed by QCDRs. In the circumstances where a QCDR wants to use a QCDR measure for inclusion in the MIPS program for reporting, those measures go through a CMS approval process during the QCDR self-nomination period. We also established that we post the quality measures for use by QCDRs by no later than January 1 for performance periods occurring in 2018 and future years.
Previously finalized MIPS quality measures can be found in the CY 2017 Quality Payment Program final rule (81 FR 77558 through 77675). Updates may include the addition of proposed new MIPS quality measures, including measures selected 2 years ago during the Call for Measures process. The new MIPS quality measures proposed for inclusion in MIPS for the 2018 performance period and future years were found in Table A of the CY 2018 Quality Payment Program proposed rule (82 FR 30261 through 30270). The proposed new and modified MIPS specialty sets for the 2018 performance period and future years were listed in Table B of the CY 2018 Quality Payment Program proposed rule (82 FR 30271 through 30454), and included existing measures that were proposed with modifications, new measures, and measures finalized in the CY 2017 Quality Payment Program final rule. We noted that the modifications made to the specialty sets may include the removal of certain quality measures that were previously finalized. The specialty measure sets should be used as a guide for eligible clinicians to choose measures applicable to their specialty. To clarify, some of the MIPS specialty sets have further defined subspecialty sets, each of which is effectively a separate specialty set. In instances where an individual MIPS eligible clinician or group reports on a specialty or subspecialty set, if the set has less than six measures, that is all the clinician is required to report. MIPS eligible clinicians are not required to report on the specialty measure sets, but they are suggested measures for specific specialties. Throughout measure utilization, measure maintenance should be a continuous process done by the measure owners, to include environmental scans of scientific literature about the measure. New information gathered during this ongoing review may trigger an ad hoc review. Please note that these specialty specific measure sets are not all inclusive of every specialty or subspecialty. On January 25, 2017, we announced that we would be accepting
As a result, we proposed (82 FR 30045) to add new quality measures to MIPS (Table A in the proposed rule (82 FR 30261 through 30270)), revise the specialty measure sets in MIPS (Table B in the proposed rule (82 FR 30271 through 30454)), remove specific MIPS quality measures only from specialty sets (Table C.1 in the proposed rule (82 FR 30455 through 30462)), and proposed to remove specific MIPS quality measures from the MIPS program for the 2018 performance period (Table C.2 in the proposed rule (82 FR 30463 through 30465)). In addition, we proposed to also remove cross cutting measures from most of the specialty sets. Specialty groups and societies reported that cross cutting measures may or may not be relevant to their practices, contingent on the eligible clinicians or groups. We chose to retain the cross cutting measures in Family Practice, Internal Medicine, and Pediatrics specialty sets because they are frequently used in these practices. The proposed 2017 cross cutting measures (81 FR 28447 through 28449) were compiled and placed in a separate table for eligible clinicians to elect to use or not, for reporting. To clarify, the cross-cutting measures are intended to provide clinicians with a list of measures that are broadly applicable to all clinicians regardless of the clinician's specialty. Even though it is not required to report on cross-cutting measures, it is provided as a reference to clinicians who are looking for additional measures to report outside their specialty. We continue to consider cross-cutting measures to be an important part of our quality measure programs, and seek comment on ways to incorporate cross-cutting measures into MIPS in the future. The Table of Cross-Cutting Measures can be found in Table D of the Appendix in the CY 2018 Quality Payment Program proposed rule (82 FR 30466 through 30467).
For MIPS quality measures that are undergoing substantive changes, we proposed to identify measures including, but not limited to measures that have had measure specification, measure title, and domain changes. MIPS quality measures with proposed substantive changes can be found at Table E of the Appendix in the CY 2018 Quality Payment Program proposed rule (82 FR 30468 through 30478).
The measures that would be used for the APM scoring standard and our authority for waiving certain measure requirements are described in section II.C.6.g.(3)(b)(ii) of this final rule with comment period, and the measures that would be used to calculate a quality score for the APM scoring standard are proposed in Tables 14, 15, and 16 of the CY 2018 Quality Payment Program proposed rule (82 FR 30091 through 30095).
We also sought comment on whether there are any MIPS quality measures that commenters believe should be classified in a different NQS domain than what is being proposed, or that should be classified as a different measure type (for example, process vs. outcome) than what we proposed (82 FR 30045). We did not receive any public comments in response to this solicitation.
The following is a summary of the public comments received on the “Background and Policies for the Call for Measures and Measure Selection Process proposals and our responses:
As defined in the CY 2017 Quality Payment Program final rule at (81 FR 77136), a measure may be considered topped out if measure performance is so high and unvarying that meaningful distinctions and improvement in performance can no longer be made. Topped out measures could have a disproportionate impact on the scores for certain MIPS eligible clinicians, and provide little room for improvement for the majority of MIPS eligible clinicians. We refer readers to section II.C.7.a.(2)(c) of this final rule with comment period for additional information regarding the scoring of topped out measures.
Although we proposed a 3-year timeline to identify and propose to remove (through future rulemaking) topped out measures (82 FR 30046). We would like to clarify that the proposed timeline is more accurately described as a 4-year timeline. After a measure has been identified as topped out for 3 consecutive years, we may propose to remove the measure through notice-and-comment rulemaking for the 4th year. Therefore, in the 4th year, if finalized through rulemaking, the measure would be removed and would no longer be available for reporting during the performance period. This proposal would provide a path toward removing topped out measures over time, and will
We proposed to phase in this policy starting with a select set of six highly topped out measures identified in section II.C.7.a.(2)(c) of this final rule with comment period. We also proposed to phase in special scoring for measures identified as topped out in the published benchmarks for 2 consecutive performance periods, starting with the select set of highly topped out measures for the 2018 MIPS performance period. An example illustrating the proposed timeline for the removal and special scoring of topped out measures, as it would be applied to the select set of highly topped out measures identified in section II.C.7.a.(2)(c) of this final rule with comment period, is as follows:
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For all other measures, the timeline would apply starting with the benchmarks for the 2018 MIPS performance period. Thus, the first year any other topped out measure could be proposed for removal would be in rulemaking for the 2021 MIPS performance period, based on the benchmarks being topped out in the 2018, 2019, and 2020 MIPS performance periods. If the measure benchmark is not topped out during one of the 3 MIPS performance periods, then the lifecycle would stop and start again at year 1 the next time the measure benchmark is topped out.
We sought comment on the proposed timeline; specifically, regarding the number of years before a topped out measure is identified and considered for removal, and under what circumstances we should remove topped out measures once they reach that point (82 FR 30046). We also noted that if for some reason a measure benchmark is topped out for only one submission mechanism benchmark, then we would remove that measure from the submission mechanism, but not remove the measure from other submission mechanisms available for submitting that measure. The comments we received and our responses are discussed further below.
We also sought comment on whether topped out Summary Survey Measures (SSMs), if topped out, should be considered for removal from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS Clinician or Group Survey measure due to high, unvarying performance within the SSM, or whether there is another alternative policy that could be applied for topped out SSMs within the CAHPS for MIPS Clinician or Group Survey measure (82 FR 30046). We received a comment on this item and appreciate the input received. As this was a request for comment only, we will take the feedback provided into consideration for future rulemaking.
In the CY 2017 Quality Payment Program final rule, we stated that we do not believe it would be appropriate to remove topped out measures from the CMS Web Interface for the Quality Payment Program because the CMS Web Interface measures are used in MIPS and in APMs, such as the Shared Savings Program. Removing topped out measures from the CMS Web Interface would not be appropriate because we have aligned policies where possible, with the Shared Savings Program, such as using the Shared Savings Program benchmarks for the CMS Web Interface measures (81 FR 77285). In the CY 2017 Quality Payment Program final rule, we also finalized that MIPS eligible clinicians reporting via the CMS Web Interface must report all measures included in the CMS Web Interface (81 FR 77116). Thus, if a CMS Web Interface measure is topped out, the CMS Web Interface reporter cannot select other measures. We refer readers to section II.C.7.a.(2) of this final rule with comment period for information on scoring policies with regards to topped out measures from the CMS Web Interface for the Quality Payment Program. We did not propose to include CMS Web Interface measures in our proposal on removing topped out measures.
The following is a summary of the public comments received on the “Topped Out Measures” proposals and our responses:
In the CY 2017 Quality Payment Program final rule, we sought comment on whether we should remove non-outcomes measures for which performance cannot reliably be scored against a benchmark (for example, measures that do not have 20 reporters with 20 cases that meet the data completeness standard) for 3 years in a row (81 FR 77288).
Based on the need for CMS to further assess this issue, we did not propose to remove non-outcome measures. However, we sought comment on what the best timeline for removing both non-outcome and outcome measures that cannot be reliably scored against a benchmark for 3 years (82 FR 30047). We received a number of comments on this item and appreciate the input received. As this was a request for comment only, we will take the feedback provided into consideration for future rulemaking.
Under the MIPS, individual MIPS eligible clinicians are generally required to submit at least one outcome measure, or, if no outcome measure is available, one high priority measure. As such, our determinations as to whether a measure is an outcome measure is of importance to stakeholders. We did not make any proposals on how quality measures are determined to be outcome measures, and refer readers to the CY 2018 Quality Payment Program proposed rule (82 FR 30047) for the criteria utilized in determining if a measure is considered an outcome measure. We sought comment on the criteria and process outlined in the proposed rule on how we designate outcome measures (82 FR 30047). We received a number of comments on this item and appreciate the input received. As this was a request for comment only, we will take the feedback provided into consideration for future rulemaking.
Measuring cost is an integral part of measuring value as part of MIPS. In implementing the cost performance category for the transition year (2017 MIPS performance period/2019 MIPS payment year), we started with measures that had been used in previous programs (mainly the VM) but noted our intent to move towards episode-based measurement as soon as possible, consistent with the statute and the feedback from the clinician community. Specifically, we adopted 2 measures that had been used in the VM: The total per capita costs for all attributed beneficiaries measure (referred to as the total per capita cost measure); and the MSPB measure (81 FR 77166 through 77168). We also adopted 10 episode-based measures that had previously been included in the Supplemental Quality and Resource Use Reports (sQRURs) (81 FR 77171 through 77174).
At § 414.1325(e), we finalized that all measures used under the cost performance category would be derived from Medicare administrative claims data and, thus, participation would not require additional data submission. We finalized a reliability threshold of 0.4 for measures in the cost performance category (81 FR 77170). We also finalized a case minimum of 35 for the MSPB measure (81 FR 77171) and 20 for the total per capita cost measure (81 FR 77170) and each of the 10 episode-based measures (81 FR 77175) in the cost performance category to ensure the reliability threshold is met.
For the transition year, we finalized a policy to weight the cost performance category at zero percent of the final score in order to give clinicians more opportunity to understand the attribution and scoring methodologies and gain more familiarity with the measures through performance feedback so that clinicians may take action to improve their performance (81 FR 77165 through 77166). In the CY 2017 Quality Payment Program final rule, we finalized a cost performance category weight of 10 percent for the 2020 MIPS payment year (81 FR 77165). For the 2021 MIPS payment year 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)(II)(aa) of the Act.
For descriptions of the statutory basis and our existing policies for the cost performance category, we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77162 through 77177).
As finalized at § 414.1370(g)(2), the cost performance category is weighted at zero percent for MIPS eligible clinicians scored under the MIPS APM scoring standard because many MIPS APMs incorporate cost measurement in other ways. For more on the APM scoring standard, see II.C.6.g. of this final rule with comment period.
We proposed at § 414.1350(b)(2) to change the weight of the cost performance category from 10 percent to zero percent for the 2020 MIPS payment year. We noted that we continue to have concerns about the level of familiarity with and understanding of cost measures among clinicians. We noted that we could use the additional year where the cost performance category would not affect the final score to increase understanding of the measures so that clinicians would be more comfortable with their role in reducing costs for their patients. In addition, we could use this additional year to develop and refine episode-based cost measures, which are cost measures that are focused on clinical conditions or procedures. We intend to propose in future rulemaking policies to adopt episode-based measures currently in development.
Although we believed that reducing this weight could be appropriate given the level of understanding of the measures and the scoring standards, we noted that section 1848(q)(5)(E)(i)(II)(aa) of the Act requires the cost performance category to be assigned a weight of 30 percent of the MIPS final score beginning in the 2021 MIPS payment year. We recognized that assigning a zero percent weight to the cost performance category for the 2020 MIPS payment year may not provide a smooth enough transition for integrating cost measures into MIPS and may not provide enough encouragement to clinicians to review their performance on cost measures. Therefore, we sought comment on keeping the weight of the cost performance category at 10 percent for the 2020 MIPS payment year (82 FR 30048).
We invited public comments on this proposal of a zero percent weighting for the cost performance category and the alternative option of a 10 percent weighting for the cost performance category for the 2020 MIPS payment year (82 FR 30048).
The following is a summary of the public comments received on these proposals and our responses:
Under § 414.1350(a), we specify cost measures for a performance period to assess the performance of MIPS eligible clinicians on the cost performance category. For the 2017 MIPS performance period, we will utilize 12 cost measures that are derived from Medicare administrative claims data. Two of these measures, the MSPB measure and total per capita cost measure, have been used in the VM (81 FR 77166 through 77168), and the remaining 10 are episode-based measures that were included in the sQRURs in 2014 and 2015 (81 FR 77171 through 77174).
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, which we summarized in detail in the CY 2018 Quality Payment Program proposed rule (82 FR 30048).
For the 2018 MIPS performance period and future performance periods, we proposed to include in the cost performance category the total per capita cost measure and the MSPB measure as finalized for the 2017 MIPS performance period (82 FR 30048 through 30049). We referred readers to the description of these measures in the CY 2017 Quality Payment Program final rule (81 FR 77164 through 77171). We proposed to include the total per capita cost measure because it is a global measure of all Medicare Part A and Part B costs during the performance period. MIPS eligible clinicians are familiar with the total per capita cost measure because the measure has been used in the VM since the 2015 payment adjustment period and performance feedback has been provided through the annual QRUR since 2013 for a subset of groups that had 20 or more eligible professionals) and to all groups in the annual QRUR since 2014 and mid-year QRUR since 2015. We proposed to use the MSPB measure because many MIPS eligible clinicians will be familiar with the measure from the VM, where it has been included since the 2016 payment adjustment period and in annual QRUR since 2014 and the mid-year QRUR since 2015, or its hospital-specified version, which has been a part of the Hospital VBP Program since 2015. In addition to familiarity, these two measures cover a large number of patients and provide an important measurement of clinician contribution to the overall population that a clinician encounters.
We did not propose any changes to the methodologies for payment standardization, risk adjustment, and specialty adjustment for these measures and refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77164 through 77171) for more information about these methodologies.
We noted that we will continue to evaluate cost measures that are included in MIPS on a regular basis and anticipate that measures could be added or removed, subject to rulemaking under applicable law, as measure development continues. We will also maintain the measures that are used in the cost performance category by updating specifications, risk adjustment, and attribution as appropriate. We anticipate including a list of cost measures for a given performance period in annual rulemaking.
The following is a summary of the public comments received on these proposals and our responses:
Episode-based measures differ from the total per capita cost measure and MSPB measure because their specifications only include services that are related to the episode of care for a clinical condition or procedure (as defined by procedure and diagnosis codes), as opposed to including all services that are provided to a patient over a given period of time. For the 2018 MIPS performance period, we did not propose to include in the cost performance category the 10 episode-based measures that we adopted for the 2017 MIPS performance period in the CY 2017 Quality Payment Program final rule (81 FR 77171 through 77174). We instead will work to develop new episode-based measures, with significant clinician input, for future performance periods.
We received extensive comments on our proposal to include 41 of these episode-based measures for the 2017 MIPS performance period, which we responded to in the CY 2017 Quality Payment Program final rule (81 FR 77171 through 77174). We also received additional comments after publication of that final rule with comment period about the decision to include 10 episode-based measures for the 2017 MIPS performance period. Although comments were generally in favor of the inclusion of episode-based measures in the future, there was also overwhelming stakeholder interest in more clinician involvement in the development of these episode-based measures as required by section 1848(r)(2) of the Act. Although there was an opportunity for clinician involvement in the development of some of the episode-based measures included for the 2017 MIPS performance period, it was not as extensive as the process we are currently using to develop episode-based measures. We believe that the new episode-based measures, which we intend to propose in future rulemaking to include in the cost performance category for the 2019 MIPS performance period, will be substantially improved by more extensive stakeholder feedback and involvement in the process.
A draft list of care episodes and patient condition groups that could become episode-based measures used in the Quality Payment Program, along with trigger codes that would indicate the beginning of the episode, was posted for comment in December 2016 (
In addition, a technical expert panel has met to provide oversight and guidance for our development of episode-based cost measures. The technical expert panel has offered recommendations for defining an episode group, assigning costs to the group, attributing episode groups to clinicians, risk adjusting episodes, and aligning cost and quality. This expert feedback has been built into the current cost measure development process.
As this process continues, we are continuing to seek input from clinicians. We believe that episode-based measures will benefit from this comprehensive approach to development. In addition, because it is possible that the new episode-based measures under development could address similar conditions as those in the episode-based measures finalized for the 2017 MIPS performance period, we believe that it would be better to focus attention on the new episode-based measures, so that clinicians would not receive feedback or scores from two measures for the same patient condition or procedure. We will endeavor to have as many episode-based measures available as possible for the 2019 MIPS performance period but will continue to develop measures for potential consideration in the more distant future.
Although we did not propose to include any episode-based measures in
As previously finalized in the in the CY 2017 Quality Payment Program final rule (81 FR 77173), the 10 episode-based measures (which we did not propose for the 2018 MIPS performance period) will be used for determining the cost performance category score for the 2019 MIPS payment year in conjunction with the MSPB measure and the total per capita cost measure, although the cost performance category score will be weighted at zero percent in that year.
The following is a summary of the public comments received and our responses:
In the CY 2017 Quality Payment Program final rule, we changed the list of primary care services that had been used to determine attribution for the total per capita cost measure by adding transitional care management (CPT codes 99495 and 99496) codes and a chronic care management code (CPT code 99490) (81 FR 77169). In the CY 2017 Physician Fee Schedule final rule, we changed the payment status for two existing CPT codes (CPT codes 99487 and 99489) that could be used to describe care management from B (bundled) to A (active) meaning that the services would be paid under the Physician Fee Schedule (81 FR 80349). The services described by these codes are substantially similar to those described by the chronic care management code that we added to the list of primary care services beginning with the 2017 performance period. We therefore proposed to add CPT codes 99487 and 99489, both describing complex chronic care management, to the list of primary care services used to attribute patients under the total per capita cost measure (82 FR 30050).
We did not propose any changes to the attribution methods for the MSPB measure and referred readers to the CY 2017 Quality Payment Program final rule (81 FR 77168 through 77169) for more information.
The following is a summary of the public comments received on these proposals and our responses:
In the CY 2017 Quality Payment Program final rule (81 FR 77169 through 77170), we finalized a reliability threshold of 0.4 for measures in the cost performance category. Reliability is an important evaluation for cost measures to ensure that differences in performance are not the result of random variation. In the proposed rule, we provided a summary of the importance of reliability in measurement and how high reliability must be balanced with other goals, such as measuring where there is significant variation and ensuring that cost measurement is not limited to large groups with large case volume (82 FR 30050). Although we did not propose any adjustments to our reliability policies, we did receive a number of comments on issues related to reliability which we will consider as part of future rulemaking. We will continue to evaluate reliability as we develop new measures and to ensure that our measures meet an appropriate standard.
We did not propose any changes for how we attribute cost measures to individual and group reporters. We refer readers to the CY 2017 Quality Payment Program final rule for more information (81 FR 77175 through 77176). Although we did not propose any adjustments to our attribution policies, we did receive a number of comments on issues related to attribution which we will consider as part of future rulemaking.
Both measures proposed for inclusion in the cost performance category for the 2018 MIPS performance period are risk adjusted at the measure level. Although the risk adjustment of the 2 measures is not identical, in both cases it is used to recognize the higher risk associated with demographic factors (such as age) or certain clinical conditions. We recognize that the risks accounted for with this adjustment are not the only potential attributes that could lead to a higher cost patient. Stakeholders have pointed to many other factors such as income level, race, and geography that they believe contribute to increased costs. These issues and our plans for attempting to address them are discussed in length in section II.C.7.b.(1)(a) of this final rule with comment period. While we did not propose any changes to address risk adjustment for cost measures in this rule, we continue to believe that this is an important issue and it will be considered carefully in the development of future cost measures and for the overall cost performance category. Although we did not propose any adjustments to our policies on incorporating cost measures with SES or risk adjustment, we did receive a number of comments which we will consider as part of future rulemaking.
In the CY 2018 Quality Payment Program proposed rule (82 FR 30098), we discussed our proposal to assess performance on any measures impacted by ICD-10 updates based only on the first 9 months of the 12-month performance period. Because the total per capita cost and MSPB measures include costs from all Medicare Part A and B services, regardless of the specific ICD-10 codes that are used on claims, and do not assign patients based on ICD-10, we do not anticipate that any measures for the cost performance category would be affected by this ICD-10 issue during the 2018 MIPS performance period. However, as we continue our plans to expand cost measures to incorporate episode-based measures, ICD-10 changes could become important. Episode-based measures may be opened (triggered) by and may assign services based on ICD-10 codes. Therefore, a change to ICD-10 coding could have a significant effect on an episode-based measure. Changes to ICD-10 codes will be incorporated into the measure specifications on a regular basis through the measure maintenance process. Please refer to section II.C.7.a.(1)(c) of this final rule with comment period for a summary of the comments and our response on this issue.
We did not propose changes to the policy we finalized in the CY 2017 Quality Payment Program final rule (81 FR 77176) that we will attribute cost measures to non-patient facing MIPS eligible clinicians who have sufficient case volume, in accordance with the attribution methodology. Although we did not propose any adjustments to our attribution of cost measures to non-patient facing MIPS eligible clinicians with sufficient case volume policies, we did receive a few comments which we will consider as part of future rulemaking.
Section 1848(q)(2)(C)(iv) of the Act requires the Secretary to consider 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 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 involved.
We believe that non-patient facing clinicians are an integral part of the care team and that their services do contribute to the overall costs but at this time we believe it better to focus on the development of a comprehensive system of episode-based measures which focus
We will continue to explore methods to incorporate non-patient facing clinicians into the cost performance category in the future.
In the CY 2018 Quality Payment Program proposed rule (82 FR 30123), we discussed our proposal to implement section 1848(q)(2)(C)(ii) of the Act by assessing clinicians who meet certain requirements and elect participation based on the performance of their associated hospital in the Hospital VBP Program. We refer readers to section II.C.7.a.(4) of this final rule with comment period for full details on the final policies related to facility-based measurement, including the measures and how the measures are scored, for the cost performance category.
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 individual MIPS eligible clinicians or groups and allows the Secretary, to the extent feasible and appropriate, to apply alternative measures and activities to such individual 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 individual MIPS eligible clinicians or groups meet the criteria set. For a detailed discussion of the feedback received from the MIPS and APMs RFI, see the CY 2017 Quality Payment Program 2017 final rule (81 FR 77177).
In the CY 2017 Quality Payment Program final rule (81 FR 77178), we defined improvement activities at § 414.1305 as an activity that relevant MIPS eligible clinicians, 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.
In the CY 2017 Quality Payment Program final rule (81 FR 77199), we solicited comments on activities that would advance the usage of health IT to support improvement activities for future consideration. Please refer to the CY 2018 Quality Payment Program proposed rule (82 FR 30052) for a full discussion of the public comments we received in response to the CY 2017 Quality Payment Program final rule and our responses provided on activities that would advance the usage of health IT to support improvement activities.
In the CY 2018 Quality Payment Program proposed rule (82 FR 30052), we sought comment on how we might provide flexibility for MIPS eligible clinicians to effectively demonstrate improvement through health IT usage while also measuring such improvement for future consideration. We received many comments on this topic and will take them into consideration for future rulemaking.
In the CY 2017 Quality Payment Program final rule (81 FR 77179 through 77180), we finalized at § 414.1355 that the improvement activities performance category would account for 15 percent of the final score. We also finalized at § 414.1380(b)(3)(iv) criteria for recognition as a certified patient-centered medical home or comparable specialty practice. Since then, it has come to our attention that the common terminology utilized in the general medical community for “certified” patient-centered medical home is “recognized” patient-centered medical home.
Therefore, in order to provide clarity, in the CY 2018 Quality Payment Program proposed rule (82 FR 30052), we proposed that the term “recognized” be accepted as equivalent to the term “certified” when referring to the requirements for a patient-centered medical home to receive full credit for the improvement activities performance category for MIPS. Specifically, we proposed to revise § 414.1380(b)(3)(iv) to provide that a MIPS eligible clinician or group in a practice that is certified or recognized 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. A practice is certified or recognized as a patient-centered medical home if it meets any of the criteria specified under § 414.1380(b)(3)(iv).
We invited public comment on this proposal.
As previously explained in the CY 2017 Quality Payment Program final rule (81 FR 77194), we believe that high weighting should be used for activities that directly address areas with the greatest impact on beneficiary care, safety, health, and well-being. In the CY 2017 Quality Payment Program final rule (81 FR 77198), we requested commenters' specific suggestions for additional activities or activities that may merit additional points beyond the “high” level for future consideration.
For MIPS eligible clinicians participating in MIPS APMs, in the CY 2017 Quality Payment Program final rule (81 FR 77185) we finalized a policy to reduce reporting burden through the APM scoring standard for this performance category to recognize improvement activities work performed through participation in MIPS APMs. This policy is codified at § 414.1370(g)(3), and we refer readers to the CY 2017 Quality Payment Program final rule for further details on reporting and scoring this performance category under the APM Scoring Standard (81 FR 77259 through 77260). In the CY 2018 Quality Payment Program proposed rule, we did not propose any changes to these policies.
We received many comments on this topic and will take them into consideration for future rulemaking.
In the CY 2017 Quality Payment Program final rule (81 FR 77180), we discussed that for the transition year of MIPS, we would 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 through attestation. Specifically, in the CY 2017 Quality Payment Program final rule (81 FR 77180), we finalized a policy that regardless of the data submission method, with the exception of MIPS eligible clinicians in MIPS APMs, all individual MIPS eligible clinicians or groups must select activities from the Improvement Activities Inventory. In addition, we codified at § 414.1360, that for the transition year of MIPS, all individual MIPS eligible clinicians or groups, or third party intermediaries such as health IT vendors, QCDRs and qualified registries that submit on behalf of an individual MIPS eligible clinician or group, must designate a “yes” response for activities on the Improvement Activities Inventory. We also codified at § 414.1360 that in the case where an individual MIPS eligible clinician or group is using a health IT vendor, QCDR, or qualified registry for their data submission, the individual MIPS eligible clinician or group will validate the improvement activities that were performed, and the health IT vendor, QCDR, or qualified registry would submit on their behalf.
We would like to maintain stability in the Quality Payment Program and continue these policies into future years. In the CY 2018 Quality Payment proposed rule (82 FR 30053), we proposed to update § 414.1360 for the transition year of MIPS and future years, to reflect that all individual MIPS eligible clinicians or groups, or third party intermediaries such as health IT vendors, QCDRs and qualified registries that submit on behalf of an individual MIPS eligible clinician or group, must designate a “yes” response for activities on the Improvement Activities Inventory. We note that these are the same requirements as previously codified for the transition year; requirements for the transition year remain unchanged. We merely proposed to extend the same policies for future years.
In addition, in the case where an individual MIPS eligible clinician or group is using a health IT vendor, QCDR, or qualified registry for their data submission, we proposed that the MIPS eligible clinician or group will certify all improvement activities were performed and the health IT vendor, QCDR, or qualified registry would submit on their behalf (82 FR 30053). In summary, we proposed to continue our previously established policies for future years and to generally apply our group policies to virtual groups. Furthermore, we refer readers to the CY 2018 Quality Payment Program proposed rule at (82 FR 30029) and section II.C.4.d. of this final rule, where we are finalizing to generally apply our group policies to virtual groups.
While we previously codified at § 414.1325(d) in the CY 2017 Quality Payment Program final rule that individual MIPS eligible clinicians and groups may only use one submission mechanism per performance category, (81 FR 77275), in section II.C.6.a.(1) of this final rule with comment period, we are finalizing our proposal, with modification, to revise § 414.1325(d) for purposes of the 2021 MIPS payment year and future years to allow individual MIPS eligible clinicians and groups to submit measures and activities, as applicable, via as many submission mechanisms as necessary to meet the requirements of the quality, improvement activities, or advancing care information performance categories. We refer readers to section II.C.6.a.(1) of this final rule with comment period for discussion of this proposal as finalized.
We also included a designation column in the Improvement Activities Inventory at Table H in the Appendix of the CY 2017 Quality Payment Program final rule (81 FR 77817) that indicated which activities qualified for the advancing care information bonus codified at § 414.1380. In future updates to the Improvement Activities Inventory, we intend to continue to indicate which activities qualify for the advancing care information performance category bonus.
We invited public comment on our proposals.
In the CY 2017 Quality Payment Program final rule (81 FR 77181), we clarified that if one MIPS eligible clinician (NPI) in a group completed an improvement activity, the entire group (TIN) would receive credit for that activity. In addition, we specified that all MIPS eligible clinicians reporting as a group would receive the same score for the improvement activities performance category if at least one clinician within the group is performing the activity for a continuous 90 days in the performance period. We refer readers to section II.C.4.d. of this final rule with comment period, where we are finalizing to generally apply our group policies to virtual groups. We did not propose any changes to our group reporting policies in the proposed rule. However, in the CY 2017 Quality Payment Program proposed rule (82 FR 30053), we requested comment for future consideration on whether we should establish a minimum threshold (for example, 50 percent) of the clinicians (NPIs) that must complete an improvement activity in order for the entire group (TIN) to receive credit in the improvement activities performance category in future years. In addition, we requested comments for future consideration on recommended minimum threshold percentages and whether we should establish different thresholds based on the size of the group. In the proposed rule, (82 FR 30053), we noted that we are concerned that while establishing any specific threshold for the percentage of NPIs in a TIN that must participate in an improvement activity for credit will incentivize some groups to move closer to the threshold, it may have the unintended consequence of incentivizing groups who are exceeding the threshold to gravitate back toward the threshold. Therefore, we requested comments for future consideration on how to set this threshold while maintaining the goal of promoting greater participation in an improvement activity.
Additionally, we noted in the CY 2017 Quality Payment Program final rule (81 FR 77197) that we intended, in future years, to score the improvement activities performance category based on performance and improvement, rather than simple attestation. In the CY 2018 Quality Payment Program proposed rule (82 FR 30053), we sought comment on how we could measure performance and improvement for future consideration; we were especially interested in ways to measure performance without imposing additional burden on eligible clinicians, such as by using data captured in eligible clinicians' daily work.
We received many comments on these topics and will take them into consideration as we craft for future policies.
In the CY 2017 Quality Payment Program final rule (81 FR 77185), we finalized 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 four medium-weighted improvement activities, or some combination of high and medium-weighted improvement activities. While the minimum reporting period for one improvement activity is 90 days, the maximum frequency with which an improvement activity may be reported would be once during the 12-month performance period (81 FR 77185). In addition, we refer readers to section II.C.4.d. of this final rule with comment period, where we are finalizing to generally apply group policies to virtual groups.
In the CY 2017 Quality Payment Program final rule (81 FR 77185), we established exceptions to the above for: Small practices; practices located in rural areas; practices located in geographic HPSAs; non-patient facing individual MIPS eligible clinicians or groups; and individual MIPS eligible clinicians and groups that participate in a MIPS APM or a patient-centered medical home submitting in MIPS. Specifically, for individual MIPS eligible clinicians and groups that are small practices, practices located in rural areas or geographic HPSAs, or non-patient facing individual MIPS eligible clinicians or groups, to achieve the highest score, one high-weighted or two medium-weighted improvement activities are required (81 FR 77185). For these individual MIPS eligible clinicians and groups, in order to achieve one-half of the highest score, one medium-weighted improvement activity is required (81 FR 77185).
In the CY 2017 Quality Payment Program final rule (81 FR 77185), we finalized that under the APM scoring standard, all clinicians identified on the Participation List of an APM receive at least one-half of the highest score applicable to the MIPS APM. To develop the improvement activities score assigned to each MIPS APM, we compare the requirements of the specific MIPS APM with the list of activities in the Improvement Activities Inventory and score those activities in the same manner that they are otherwise scored for MIPS eligible clinicians (81 FR 77185). If by our assessment the MIPS APM does not receive the maximum improvement activities performance category score then the APM entity can submit additional
We received many comments on this topic and will take them into consideration for future rulemaking.
In the CY 2017 Quality Payment Program final rule (81 FR 77185), we finalized at § 414.1380(b)(3)(iv) to provide full credit for the improvement activities performance category, as required by law, for an individual 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, or for an individual MIPS eligible clinician or group that is a participant in a medical home model. We noted in the CY 2017 Quality Payment Program final rule (81 FR 77178) that practices may receive this designation at a practice level and that TINs may be comprised of both undesignated practices and designated practices. We finalized at § 414.1380(b)(3)(viii) that to receive full credit as a certified patient-centered medical home or comparable specialty practice, a TIN that is reporting must include at least one practice site which is a certified patient-centered medical home or comparable specialty practice (81 FR 77178). We also indicated that we would continue to have more stringent requirements in future years, and would lay the groundwork for expansion towards continuous improvement over time (81 FR 77189).
We received many comments on the CY 2017 Quality Payment Program final rule regarding our transition year policy that only one practice site within a TIN needs to be certified as a patient-centered medical home for the entire TIN to receive full credit in the improvement activities performance category. While several commenters supported our transition year policy, others disagreed and suggested to move to a more stringent requirement in future years while still offering some flexibility. We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77180 through 77182) for the details of those comments and our responses. In response to these comments, in the CY 2018 Quality Payment Program proposed rule (82 FR 30054), we proposed to revise § 414.1380(b)(3)(x) to provide that for the 2020 MIPS payment year and future years, to receive full credit as a certified or recognized patient-centered medical home or comparable specialty practice, at least 50 percent of the practice sites within the TIN must be recognized as a patient-centered medical home or comparable specialty practice. This is an increase to the previously established requirement codified at § 414.1380(b)(3) in the CY 2017 Quality Payment Program final rule (81 FR 77178) that only one practice site within a TIN needs to be certified as a patient-centered medical home. We chose not to propose to require that every site be certified, because that could potentially be overly restrictive given that some sites within a TIN may be in the process of being certified as patient-centered medical homes. We believe a 50 percent threshold is achievable, and is supported by a study of physician-owned primary care groups in a recent Annals of Family Medicine article (Casalino, et al., 2016)
In the CY 2018 QPP proposed rule (82 FR 30054 through 55) we invited public comments on our proposals to revise § 414.1380(b)(3)(x) to provide that for the 2020 MIPS payment year and future years, to receive full credit as a certified or recognized patient-centered medical home or comparable specialty practice, at least 50 percent of the practice sites within the TIN must be recognized as a patient-centered medical home or comparable specialty practice. However, we are correcting here that we intended to add § 414.1380(b)(3)(x) as a new provision, not revise it. This was an inadvertent typographical error. The following is a summary of the public comments received and our responses.
Several commenters expressed concern that the proposed threshold is premature and may interfere with their ability to report participation in an improvement activity that may be unique to their specialty group or discourage participation by some clinicians in the medical home models altogether.
Other commenters expressed concern that CMS's proposed policy fails to account for the effort and investment required to achieve this designation, and fails to account for how the work of those sites that do achieve such recognition impacts specialty clinics within a TIN by ensuring coordinated primary care for patients as those practice sites refer patients needing specialized care who cannot be managed by primary care. Some commenters recommended that CMS consider alternatives to our proposal. A few commenters recommended a threshold of 2 or more practice sites, or beginning with a lower threshold, such as 33 percent. One commenter suggested that CMS instead consider awarding prorated credit for the entire TIN that is in proportion to the percentage of the TIN that is a patient-centered medical home or comparable specialty. For example, for one practice site that is a patient-centered medical home out of five sites under the same TIN, this practice would receive 20 percent of the 100 percent credit for the performance category score, and eligible clinicians in the other four sites within the TIN would need to demonstrate other improvement activities. Although MIPS eligible clinicians may choose to receive full credit by reporting as an individual clinician, one commenter noted that this is not a reasonable alternative due to the complexity and burden required to do so as part of a large multi-specialty group. This commenter suggested that before proceeding with this policy, CMS should determine an alternative that allows a portion of a group under one TIN to report as a separate subgroup on measures and activities that are more applicable to that subgroup. This commenter suggested that alternatively, CMS could incorporate thresholds into improvement activities, consider a variety of thresholds (for example, clinicians participating, target population included, entire practice included, etc.) and adjust the thresholds based on the type of improvement activity. Another commenter suggested that CMS equate this threshold with the credit received, giving the example that if 70 percent of NPIs within a TIN are performing an improvement activity, then that group should get 70 percent credit toward that improvement activity score. Commenters suggested that this addresses the possibility of a decline in further improvement once the set threshold is achieved.
In response to the commenters who believed that the proposed threshold may interfere with their ability to report participation in an improvement activity that may be unique to their specialty group, if those specialty groups decided to use patient-centered medical home recognition as their credit for the improvement activities performance category, those specialty groups would not be able to report on improvement activities unique to their specialties. We refer commenters to our proposal above where we state that if the group is unable to meet the 50 percent threshold, then the individual MIPS eligible clinicians may choose to receive full credit as a recognized or certified patient-centered medical home, or comparable specialty practice, as an individual for all performance categories (82 FR 30054). To emphasize this point, specialty clinicians could either be recognized as a comparable specialty practice under the patient-centered medical home designation, which would reflect the specialty care they provide, or they could report on improvement activities that may be unique to their specialty group as individual reporters. Therefore, we do not believe that setting the patient-centered medical home threshold at 50 percent would interfere with a group's ability to report other specialty specific improvement activities. We believe that the suggestion that we use a threshold of 2 or more practice sites, instead of 50 percent might discourage large medical groups from investing in patient-centered medical home transformation more broadly, because many large
• 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.
We do not believe the CMS Study on Burden Associated with Quality Reporting is the appropriate vehicle to assess thresholds of participation, score practices on performance, and assess improvement. We will, however, take these comments into consideration as we craft future policies.
In the CY 2018 Quality Payment Program proposed rule (82 FR 30054) we stated that we have determined that the Comprehensive Primary Care Plus (CPC+) APM design satisfies the requirements to be designated as a medical home model, as defined in § 414.1305; and therefore, as defined at 81 FR 77178 that states that patient-centered medical homes will be recognized if it is a nationally recognized accredited patient-centered medical home, a Medicaid Medical Home Model, or a Medical Home Model, CPC+ APM is also a certified or recognized patient-centered medical home for purposes of the improvement activities performance category. We have also determined that the CPC+ APM meets the criteria to be an Advanced APM. We refer readers to
We recognized the possibility that certain practices that applied to participate in Round 2 of the CPC+ APM, but were not chosen to participate in the model, could potentially be randomized into a CPC+ control group. The control group practices would meet all of the same eligibility requirements as the CPC+ participating practices (also known as the “intervention group”) but the control group would not “participate” in the APM (for example, undertake the CPC+ care delivery activities such as providing 24/7 clinician access, or empanel attributed Medicare beneficiaries) or receive any of the CPC+ payments. In the CY 2018 Quality Payment Program proposed rule (82 FR 30015), we discussed that we believe MIPS eligible clinicians, who are participating in the CPC+ APM, whether actively in the intervention group or as part of the control group, should therefore receive full credit for the improvement activities performance category.
Accordingly, in the CY 2018 Quality Payment Program proposed rule (82 FR 30054 through 30055), we proposed that MIPS eligible clinicians in practices randomized to the control group in the CPC+ APM would receive full credit as a medical home model, and therefore, a certified patient-centered medical home, for the improvement activities performance category. In other words, MIPS eligible clinicians who attest that they are in practices that have been randomized to the control group in the CPC+ APM would receive full credit for the improvement activities performance category for each performance period in which they are on the Practitioner Roster, the official list of eligible clinicians participating in a practice in the CPC+ control group (82 FR 30054 through 30055).
We invited public comment on our proposal. The following is a summary of public comments received on this proposal and our response.
In the CY 2017 Quality Payment Program final rule (81 FR 77186), we specified 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
We received many comments on this topic and will take them into consideration for future rulemaking.
In the CY 2017 Quality Payment Program final rule (81 FR 77187), we specified at § 414.1380(b)(3)(vii) that for non-patient facing individual MIPS eligible clinicians or groups, to achieve the highest score one high-weighted or two medium-weighted improvement activities are required. For these individual MIPS eligible clinicians and groups, in order to achieve one-half of the highest score, one medium-weighted improvement activity is required (81 FR 77187). In the CY 2018 Quality Payment Program proposed rule (82 FR 30055), we did not propose any changes to the application of improvement activities to non-patient facing individual MIPS eligible clinicians and groups for the improvement activities performance category.
We received a few comments on this topic and will take them into consideration for future rulemaking.
In the CY 2017 Quality Payment Program final rule (81 FR 77188), we finalized at § 414.1380(b)(3)(vii) that one high-weighted or two medium-weighted improvement activities are required for individual MIPS eligible clinicians and groups that are small practices or located in rural areas, or geographic HPSAs, to achieve full credit. In addition, we specified at § 414.1305 that a rural area means ZIP codes designated as rural, using the most recent HRSA Area Health Resource File data set available (81 FR 77012). Lastly, in the CY 2017 Quality Payment Program final rule (81 FR 77539 through 77540), we codified the following definitions at § 414.1305: (1) Small practices is defined to mean practices consisting of 15 or eligible clinicians; and (2) Health Professional Shortage Areas (HPSA) refers to areas as designated under section 332(a)(1)(A) of the Public Health Service Act. In the CY 2018 Quality Payment Program proposed rule (82 FR 30055), we did not propose any changes to the special consideration for small, rural, or health professional shortage areas practices for the improvement activities performance category in the proposed rule.
We received many comments on this topic and will take them into consideration for future rulemaking.
In the CY 2017 Quality Payment Program final rule (81 FR 77190), we finalized 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 finalized (81 FR 77190) at § 414.1365 the following additional subcategories: Achieving Health Equity; Integrated Behavioral and Mental Health; and Emergency Preparedness and Response. In the CY 2018 Quality Payment Program proposed rule (82 FR 30055), we did not propose any changes to the improvement activities subcategories for the improvement activities performance category in the proposed rule.
We received a few comments on this topic and will take them into consideration for future rulemaking.
We refer readers to Table H in the Appendix of the CY 2017 Quality Payment Program final rule (81 FR 77817) for our previously finalized Improvement Activities Inventory for the transition year of MIPS and future years. In this final rule with comment period, we are finalizing updates to the Improvement Activities Inventory, formalizing the process for adding new improvement activities to the Improvement Activities Inventory, and finalizing the criteria for nominating new improvement activities. These are discussed in detail below.
As discussed in the CY 2017 Quality Payment Program final rule (81 FR 77190), for the transition year of MIPS, we implemented the initial Improvement Activities Inventory and took several steps to ensure it was inclusive of activities in line with statutory and program requirements. Prior to selecting the improvement activities, we conducted background research. We interviewed high 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 requirements, including the patient-centered medical homes, the Transforming Clinical Practice Initiative (TCPI), CAHPS surveys, and AHRQ's Patient Safety Organizations (81 FR 77190). In addition, we reviewed comments from the CY 2016 PFS final rule with comment period (80 FR 70886), and those received in response to the MIPS and APMs RFI published in the October 1, 2015
For the Quality Payment Program Year 2, we provided an informal process for submitting new improvement activities for potential inclusion in the comprehensive Improvement Activities Inventory for the Quality Payment Program Year 2 and future years through subregulatory guidance (
For the Quality Payment Program Year 3 and future years, in the CY 2018 Quality Payment Program proposed rule (82 FR 30055), we proposed to formalize an Annual Call for Activities process for adding possible new activities or providing modifications to the current activities in the Improvement Activities Inventory. We believe this is a way to engage eligible clinician organizations and other relevant stakeholders, including beneficiaries, in the identification and submission of improvement activities for consideration. Specifically, we proposed that individual MIPS eligible clinicians or groups and other relevant stakeholders may recommend activities for potential inclusion in the Improvement Activities Inventory via a similar nomination form that was utilized in the Year 2 of MIPS informal Annual Call for Activities found on the Quality Payment Program Web site at
We refer readers to the Improvement Activities Inventory in Tables F and G of the Appendix of this final rule with comment period where we are finalizing new activities and changes to existing activities, some with modification. We invited public comment on our proposal to formalize the Annual Call for Activities process for the Quality Payment Program Year 3 and future years.
We will take the commenters' feedback into consideration as we work to refine the Annual Call for Activities process for future years.
In the CY 2017 Quality Payment final rule (81 FR 77190), we discussed guidelines for the selection of improvement activities. In the CY 2018 Quality Payment Program proposed rule (82 FR 30055 and 30485), we formally proposed that for the Quality Payment Program Year 3 and future years, that stakeholders would apply one or more of the following criteria when submitting improvement activities in response to the proposed formal Annual Call for Activities. We intend to also use these criteria in selecting improvement activities for inclusion in the program.
• 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;
• Activities that may be considered for an advancing care information bonus;
• Representative of activities that multiple individual 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;
• Evidence supports that an activity has a high probability of contributing to improved beneficiary health outcomes; or
• CMS is able to validate the activity.
We also noted in our proposal that in future rulemaking, activities that overlap with other performance categories may be proposed to be included if such activities support the key goals of the program.
We invited public comment on our proposal. The following is a summary of the public comments received on the “Criteria for Nominating New Improvement Activities for the Annual Call for Activities” proposals and our responses.
In addition, we currently include several activities in the Improvement Activities Inventory that address barriers to care, such as IA_CC_16, Primary Care Physician and Behavioral Health Bilateral Electronic Exchange of Information for Shared Patients, which rewards primary care and behavioral health practices using the same electronic health record system for shared patients or for exchanging information bilaterally and IA_PM_18 Provide Clinical-Community Linkages, which rewards MIPS eligible clinicians engaging community health workers to provide a comprehensive link to community resources through family-based services focusing on success in health, education, and self-sufficiency. However, we will consider criteria that address “actions that reduce barriers to care” and those that identify interpretation and transportation services as we craft future policies.
• 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;
• Focus on meaningful actions from the person and family's point of view;
• Support the patient's family or personal caregiver;
• Activities that may be considered for an advancing care information bonus;
• Representative of activities that multiple individual 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;
• Evidence supports that an activity has a high probability of contributing to improved beneficiary health outcomes; or
• CMS is able to validate the activity.
During the informal process, we accepted nominations from February 16 through Febuary 28, 2017. For the Quality Payment Program Year 2, we provided an informal process for submitting new improvement activities for potential inclusion in the comprehensive Improvement Activities Inventory for the Quality Payment Program Year 2 and future years through subregulatory guidance (
It is our intention that the nomination and acceptance process for improvement activities, to the best extent possible, parallel the Annual Call for Measures process that is already conducted for MIPS quality measures. We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77147 through 77153) and section II.C.6.c.(1) of this final rule with comment period for more information. Therefore, aligned with this process, in the CY 2018 Quality Payment Program proposed rule (82 FR 30056), we proposed to accept submissions for prospective improvement activities at any time during the performance period for the Annual Call for Activities and create an Improvement Activities Under Review (IAUR) list which will be displayed on a CMS Web site. For example, the CY 2019 performance period spans January 1, 2019 through December 31, 2019, therefore, the submission period for CY 2019 prospective improvement activities would be March 2, 2017 through March 1, 2018. When submissions are received after the March 1 deadline then that submission will be included in the next performance period activities cycle. We will consider the IAUR list we make decisions on which improvement activities to include in a future Improvement Activities Inventory. We will analyze the IAUR list while considering the criteria for inclusion of improvement activities as finalized in section II.C.6.e.(7)(b) of this final rule with comment period.
In addition, in the CY 2018 Quality Payment Program proposed rule (82 FR 30056), we proposed that for the formal Annual Call for Activities, only activities submitted by March 1 would be considered for inclusion in the Improvement Activities Inventory for the performance periods occurring in the following calendar year. In other words, we will accept improvement activities at any time throughout the year, however, we will only consider those improvement activities that are received by the March 1 deadline for the following performance period. This proposal was slightly different than the Call for Measures timeline. The Annual Call for Measures requires a 2-year implementation timeline, because the measures being considered for inclusion in MIPS undergo the pre-rulemaking process with review by the Measures Application Partnership (MAP) (81 FR 77153). In order to decrease the timeframe for activity implementation, we did not propose that improvement activities also undergo MAP review. Our intention is that while we we will accept improvement activities at any time throughout the year, we will close the Annual Call for Activities submissions by March 1 before the applicable performance period, which would enable us to propose the new improvement activities for adoption in the same year's rulemaking cycle for implementation in the following year. When submissions are received after the March 1 deadline then that submission will be included in the next performance period activities cycle. For example, an improvement activity submitted to the IAUR prior to March 1, 2018 could be considered for performance periods beginning in 2019. If an improvement activity submission is submitted April 1, 2018 then the submission could be considered for performance periods beginning in 2020.
In addition, in the CY 2018 Quality Payment Program proposed rule (82 FR 30056), we proposed that we would add new improvement activities to the inventory through notice-and-comment rulemaking.
We invited public comment on our proposals.
In future years, we anticipate developing a process and establishing criteria for identifying activities for removal from the Improvement Activities Inventory through the Annual Call for Activities process. We anticipate proposing these requirements in the future through notice-and-comment rulemaking. In the CY 2018 Quality Payment Program proposed rule (82 FR 30056), we invited public comments on what criteria should be
We received a few comments on this topic and will take them into consideration for future rulemaking.
In the CY 2017 Quality Payment Program final rule (81 FR 77197), we finalized the following criteria for adding a new subcategory to the improvement activities performance category:
• 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 the CY 2018 Quality Payment Program proposed rule at (82 FR 30056), while we did not propose any changes to the approach for adding new subcategories for the improvement activities performance category, we did propose that in future years of the Quality Payment Program, we would add new improvement activities subcategories through notice-and-comment rulemaking. We did not receive any comments on this proposal and are finalizing, as proposed, that in future years of the Quality Payment Program, we will add new improvement activities subcategories through notice-and-comment rulemaking.
In the CY 2018 Quality Payment Program proposed rule at (82 FR 30056), we also sought comments on new improvement activities subcategories for future consideration. In particular, in the CY 2017 Quality Payment Program final rule (81 FR 77194), several stakeholders have suggested that a separate subcategory for improvement activities specifically related to health IT would make it easier for MIPS eligible clinicians and vendors to understand and earn points toward their final score through the use of health IT. Such a health IT subcategory could include only improvement activities that are specifically related to the advancing care information performance category measures and allow MIPS eligible clinicians to earn credit in the improvement activities performance category, while receiving a bonus in the advancing care information performance category as well. In the CY 2018 Quality Payment Program proposed rule (82 FR 30056), we sought suggestions on how a health IT subcategory within the improvement activities performance category could be structured to provide MIPS eligible clinicians with flexible opportunities to gain experience in using CEHRT and other health IT to improve their practice.
We received many comments on this topic and will take these into consideration for future rulemaking.
In the CY 2017 Quality Payment Program final rule (81 FR 77195), we finalized specifics regarding the CMS Study on Improvement Activities and Measurement including the study purpose, study participation credit and requirements, and the study procedure. In the CY 2018 Quality Payment Program proposed rule (82 FR 30056), we proposed to modify the name of the study to the “CMS Study on Burdens Associated with Reporting Quality Measures” to more accurately reflect the purpose of the study. The study assesses clinician burden and data submission errors associated with the collection and submission of clinician quality measures for MIPS, enrolling groups of different sizes and individuals in both rural and non-rural settings and also different specialties. We previously finalized that study participants receive full credit in the improvement activities performance category if they successfully elect, participate, and submit data to CMS for the full calendar year (81 FR 77196). In the CY 2017 final rule (81 FR 77195 through 77197), we requested comments on the study and received generally supportive feedback for the study.
In the CY 2018 Quality Payment Program proposed rule (82 FR 30056 through 30057), we did not propose any changes to the study purpose. However, we proposed changes to the study participation credit and requirements for sample size, how the study sample is categorized into groups, and the study procedures for the frequency of surveys, focus groups, and quality data submission. These proposals are discussed in more detail below.
In addition to performing descriptive statistics to compare the trends in errors and burden between study years 2017 and 2018 as previously finalized in the (81 FR 77196), we would like to perform a more rigorous statistical analysis with the 2018 data, which will require a larger sample size. Therefore, in the CY 2018 Quality Payment Program proposed rule (82 FR 30056), we proposed increasing the sample size for CY 2018 and beyond to provide the minimum sample needed to get a significant result with adequate power; that is, we proposed increasing the number of the study participants to provide the minimum needed to make a meaningful and factual conclusion out of the study. This is described in more detail below. The sample size, as finalized in the CY 2017 Quality Payment Program final rule (81 FR 77196), for performance periods occurring in CY 2017 consisted of 42 MIPS groups as stated by MIPS criteria from the following seven categories:
• 10 urban individual or groups of <3 eligible clinicians.
• 10 rural individual or groups of <3 eligible clinicians.
• 10 groups of 3-8 eligible clinicians.
• 5 groups of 8-20 eligible clinicians.
• 3 groups of 20-100 eligible clinicians.
• 2 groups of 100 or greater eligible clinicians.
• 2 specialty groups.
In the CY 2018 Quality Payment Program proposed rule (82 FR 30057), we proposed to increase the sample size for the performance periods occurring in CY 2018 to a minimum of:
• 20 urban individual or groups of <3 eligible clinicians,—(broken down into 10 individuals and 10 groups).
• 20 rural individual or groups of <3 eligible clinicians—(broken down into 10 individuals and 10 groups).
• 10 groups of 3-8 eligible clinicians.
• 10 groups of 8-20 eligible clinicians.
• 10 groups of 20-100 eligible clinicians.
• 10 groups of 100 or greater eligible clinicians.
• 6 groups of >20 eligible clinicians reporting as individuals—(broken down into 3 urban and 3 rural).
• 6 specialty groups—(broken down into 3 reporting individually and 3 reporting as a group).
• Up to 10 non-MIPS eligible clinicians reporting as a group or individual (any number of individuals and any group size).
In the CY 2018 Quality Payment Program proposed rule (82 FR 30057), we also proposed changes to the study procedures. In the CY 2017 Quality
In order to prevent or reduce study participants from incurring any more significant additional administrative work as compared to other MIPS eligible clinicians not participating in the study, in the CY 2018 Quality Payment Program proposed rule (82 FR 30057), we proposed that for Quality Payment Program Year 2 and future years, that study participants would be required to attend as frequently as four monthly surveys and focus group sessions throughout the year, but certain study participants would be able to attend less frequently. In other words, study participants would be required to attend a maximum of four surveys and focus group sessions throughout the year.
We previously required study measurement data to be collected at baseline and then at every 3 months (quarterly basis) afterwards for the duration of the calendar year (81 FR 77196). We also finalized a minimum requirement of three MIPS quality measures, four times within the year (81 FR 77196). We stated that we believe this is inconsistent with clinicians reporting a full year's data, as we believe some study participants may choose to submit data for all measures at one time, or alternatively, may choose to submit data up to six times during the 1-year period (82 FR 30057).
As a result, in the CY 2018 Quality Payment Program proposed rule (82 FR 30057), we proposed, for the Quality Payment Program Year 2 and future years, to offer study participants flexibility in their submissions such that they could submit all their quality measures data at once, as allowed in the MIPS program, and participate in study surveys and focus groups, while still earning improvement activities credit.
We invited public comments on our proposals.
It must be noted that although the aforementioned activities constitute an information collection request as defined in the implementing regulations of the Paperwork Reduction Act (PRA) of 1995 (5 CFR 1320), the associated burden is exempt from application of the Paperwork Reduction Act. Specifically, section 1848(s)(7) of the Act, as added by section 102 of the MACRA (Pub. L. 114-10) states that Chapter 35 of title 44, United States Code, shall not apply to the collection of information for the development of quality measures. Our goals for new measures are to develop new high quality, low cost measures that are meaningful, easily understandable and operable, that also, reliably and validly measure what they purport. This study shall inform us on the root causes of clinicians' performance measure data collection and data submission burdens and challenges that hinders accurate and timely quality measurement activities. In addition, this study will inform us on the characteristic attributes that our new measures must possess to be able to accurately capture and measure the priorities and gaps MACRA aims for, as described in the Quality Measures Development Plan.
Section 1848(q)(2)(A) of the Act includes the meaningful use of CEHRT as a performance category under the MIPS. We refer to this performance category as the advancing care information performance category, and it is 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 of the MIPS 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.
Section 1848(q)(5)(E)(i)(IV) of the Act states that 25 percent of the MIPS final score shall be based on performance for the advancing care information performance category. We established at § 414.1380(b)(4) that the score for the advancing care information performance category would be comprised of a base score, performance score, and potential bonus points for reporting on certain measures and activities. For further explanation of our scoring policies for the advancing care information performance category, we refer readers to 81 FR 77216-77227.
For the CY 2018 performance period, we did not propose any changes to the base score methodology as established in the CY 2017 Quality Payment Program final rule (81 FR 77217-77223).
In the CY 2017 Quality Payment Program final rule (81 FR 77223 through 77226), we finalized that MIPS eligible clinicians can earn 10 percentage points in the performance score for meeting the Immunization Registry Reporting Measure. We proposed to modify our policy for scoring the Public Health and Clinical Data Registry Reporting Objective beginning with the performance period in CY 2018 because we have learned that there are areas of the country where immunization registries are not available, and we did not intend to disadvantage MIPS eligible clinicians practicing in those areas. We proposed if a MIPS eligible clinician fulfills the Immunization Registry Reporting Measure, the MIPS eligible clinician would earn 10 percentage points in the performance score. If a MIPS eligible clinician cannot fulfill the Immunization Registry Reporting Measure, we proposed that the MIPS eligible clinician could earn 5 percentage points in the performance score for each public health agency or clinical data registry to which the clinician reports for the following measures, up to a maximum of 10 percentage points: Syndromic Surveillance Reporting; Electronic Case Reporting; Public Health Registry Reporting; and Clinical Data Registry Reporting. A MIPS eligible clinician who chooses to report to more than one public health agency or clinical data registry may receive credit in the performance score for the submission to more than one agency or registry; however, the MIPS eligible clinician would not earn more than a total of 10 percentage points for such reporting.
We further proposed similar flexibility for MIPS eligible clinicians who choose to report the measures specified for the Public Health Reporting Objective of the 2018 Advancing Care Information Transition Objective and Measure set. (In section II.C.6.f.(6)(b) of the proposed rule, we proposed to allow MIPS eligible clinicians to report using the 2018 Advancing Care Information Transition Objectives and Measures in 2018.) We proposed if a MIPS eligible clinician fulfills the Immunization Registry Reporting Measure, the MIPS eligible clinician would earn 10 percentage points in the performance score. If a MIPS eligible clinician cannot fulfill the Immunization Registry Reporting Measure, we proposed that the MIPS eligible clinician could earn 5 percentage points in the performance score for each public health agency or specialized registry to which the clinician reports for the following measures, up to a maximum of 10 percentage points: Syndromic Surveillance Reporting; Specialized Registry Reporting. A MIPS eligible clinician who chooses to report to more than one specialized registry or public health agency to submit syndromic surveillance data may earn 5 percentage points in the performance score for reporting to each one, up to a maximum of 10 percentage points.
The following is a summary of the public comments received on these proposals and our responses:
In the CY 2017 Quality Payment Program final rule (81 FR 77220 through 77226), for the Public Health and Clinical Data Registry Reporting Objective and the Public Health Reporting Objective, we finalized that MIPS eligible clinicians who report to one or more public health agencies or clinical data registries beyond the Immunization Registry Reporting Measure will earn a bonus score of 5 percentage points in the advancing care information performance category. Based on our proposals discussed above to allow MIPS eligible clinicians who cannot fulfill the Immunization Registry Reporting Measure to earn additional points in the performance score, we proposed to modify this policy so that MIPS eligible clinicians cannot earn points in both the performance score and bonus score for reporting to the same public health agency or clinical data registry. We proposed to modify our policy beginning with the performance period in CY 2018. We proposed that a MIPS eligible clinician may earn the bonus score of 5 percentage points for reporting to at least one additional public health agency or clinical data registry that is different from the agency/agencies or registry/or registries to which the MIPS eligible clinician reports to earn a performance score. A MIPS eligible clinician would not receive credit under both the performance score and bonus score for reporting to the same agency or registry.
We proposed that for the Advancing Care Information Objectives and Measures, a bonus of 5 percentage points would be awarded if the MIPS eligible clinician reports “yes” for any one of the following measures associated with the Public Health and Clinical Data Registry Reporting Objective: Syndromic Surveillance Reporting; Electronic Case Reporting; Public Health Registry Reporting; or Clinical Data Registry Reporting. We proposed that for the 2018 Advancing Care Information Transition Objectives and Measures, a bonus of 5 percent would be awarded if the MIPS eligible clinician reports “yes” for any one of the following measures associated with the Public Health Reporting Objective: Syndromic Surveillance Reporting or Specialized Registry Reporting. We proposed that to earn the bonus score, the MIPS eligible clinician must be in active engagement with one or more additional public health agencies or clinical data registries that is/are different from the agency or registry that they identified to earn a performance score.
The following is a summary of the public comments received on these proposals and our responses:
In the CY 2017 Quality Payment Program final rule (81 FR 77202), we discussed our approach to the measurement of the use of health IT to allow MIPS eligible clinicians and groups the flexibility to implement health IT in a way that supports their clinical needs. Toward that end, we adopted a policy to award a bonus score to MIPS eligible clinicians who use CEHRT to complete certain activities in the improvement activities performance category based on our belief that the use of CEHRT in carrying out these activities could further the outcomes of clinical practice improvement.
We adopted a final policy to award a 10 percent bonus for the advancing care information performance category if a MIPS eligible clinician attests to completing at least one of the improvement activities we have specified using CEHRT (81 FR 77209). We referred readers to Table 8 in the CY 2017 Quality Payment Program final rule (81 FR 77202-77209) for a list of the improvement activities eligible for the advancing care information performance category bonus. We proposed to expand this policy beginning with the CY 2018 performance period by identifying additional improvement activities in Table 6 (82 FR 30060-30063) that would be eligible for the advancing care information performance category bonus score if they are completed using CEHRT functionality.
The following is a summary of the public comments received on this proposal and our responses:
In the CY 2017 Quality Payment Program final rule (81 FR 77210 through 77211), we established a performance period for the advancing care information performance category to align with the overall MIPS performance period of one full year to ensure all four performance categories are measured and scored based on the same period of time. We stated for the first and second performance periods of MIPS (CYs 2017 and 2018), we will accept a minimum of 90 consecutive days of data and encourage MIPS eligible clinicians to report data for the full year performance period. We proposed the same policy for the advancing care information performance category for the performance period in CY 2019, Quality Payment Program Year 3, and would accept a minimum of 90 consecutive days of data in CY 2019.
In the CY 2017 Quality Payment Program final rule (81 FR 77211 through 77213), we outlined the requirements for MIPS eligible clinicians using CEHRT during the CY 2017 performance period for the advancing care information performance category as it relates to the objectives and measures they select to report, and also outlined requirements for the CY 2018 performance period. We additionally adopted 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.
For the CY 2017 performance period, we adopted a policy by which MIPS eligible clinicians may use EHR technology certified to either the 2014 or 2015 Edition certification criteria, or a combination of the two. For the CY 2018 performance period, we previously stated that MIPS eligible clinicians must use EHR technology certified to the 2015 Edition to meet the objectives and measures specified for the advancing care information performance category. We received significant comments from the CY 2017 Quality Payment Program final rule and feedback from stakeholders through meetings and listening sessions requesting that we extend the use of 2014 Edition CEHRT beyond CY 2017 into CY 2018. Many commenters expressed concern over the lack of products certified to the 2015 Edition. Other commenters stated that switching from the 2014 Edition to the 2015 Edition requires a large amount of time and planning and if it is rushed there is a potential risk to patient health. Also, our experience with the transition from EHR technology certified to the 2011 Edition to EHR technology certified to the 2014 Edition did make us aware of the many issues associated with the adoption of EHR technology certified to a new Edition. These include the time that will be necessary to effectively deploy EHR technology certified to the 2015 Edition standards and certification criteria and to make the necessary patient safety, staff training, and workflow investments to be prepared to report for the advancing care information performance category for 2018. Thus, we proposed that MIPS eligible clinicians may use EHR technology certified to either the 2014 or 2015 Edition certification criteria, or a combination of the two for the CY 2018 performance period. We proposed to amend § 414.1305 to reflect this change.
We further noted, that to encourage new participants to adopt certified health IT and to incentivize participants to upgrade their technology to 2015 Edition products which better support interoperability across the care continuum, we proposed to offer a bonus of 10 percentage points under the advancing care information performance category for MIPS eligible clinicians who report the Advancing Care Information Objectives and Measures for the performance period in CY 2018 using only 2015 Edition CEHRT. We proposed to amend § 414.1380(b)(4)C)(3) to reflect this change. We proposed this one-time bonus for CY 2018 to support and recognize MIPS eligible clinicians and groups that invest in implementing certified EHR technology in their practice. We sought comment on the proposed bonus, the proposed amount of percentage points for the bonus, and whether the bonus should be limited to new participants in MIPS and small practices.
The following is a summary of the public comments received on these proposals and our responses:
Section 1848(q)(5)(E)(i)(IV) of the Act states that 25 percent of the MIPS final score shall be based on performance for the advancing care information performance category. Further, section 1848(q)(5)(E)(ii) of the Act, provides that in any year in which the Secretary estimates that the proportion of eligible professionals (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 noted that section 1848(o)(5) of the Act defines an eligible professional as a physician, as defined in section 1861(r) of the Act.
In CY 2017 Quality Payment Program final rule (81 FR 77226-77227), we established a final policy, 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 established that we will base this estimation on data from the relevant performance period, if we have sufficient data available from that period. We stated that we will not include in the estimation physicians for whom the advancing care information performance category is weighted at zero percent under section 1848(q)(5)(F) of the Act, which we relied on in the CY 2017 Quality Payment Program final rule (81 FR 77226 through 77227) to establish policies under which we would weigh the advancing care information performance category at zero percent of the final score. In addition, we proposed not to include in the estimation physicians for whom the advancing care information performance category would be weighted at zero percent under the proposal in section II.C.6.f.(7) of the proposed rule to implement certain provisions of the 21st Century Cures Act (that is, physicians who are determined hospital-based or ambulatory surgical center-based, or who are granted an exception based on significant hardship or decertified EHR technology).
We stated that we were considering modifications to the policy we established in last year's rulemaking to base our estimation of physicians who are meaningful EHR users for a MIPS payment year (for example, 2019) on data from the relevant performance period (for example, 2017). We stated our concern that if in future rulemaking we decide to propose to change the weight of the advancing care information performance category based on our estimation, such a change may cause confusion to MIPS eligible clinicians who are adjusting to the MIPS program and believe this performance category will make up 25 percent of the final score for the 2019 MIPS payment year. We noted the earliest we would be able to make our estimation based on 2017 data and propose in future rulemaking to change the weight of the advancing care information performance category for the 2019 MIPS payment year would be in mid-2018, as the deadline for data submission is March 31, 2018. We requested public comments on whether this timeframe is sufficient, or whether a more extended timeframe would be preferable. We proposed to modify our existing policy such that we would base our estimation
The following is a summary of the public comments received on these proposals and our responses:
We proposed to maintain for the CY 2018 performance period the Advancing Care Information Objectives and Measures as finalized in the CY 2017 Quality Payment Program final rule (81 FR 77227 through 77229). We proposed the following modifications to certain objectives and measures.
We inadvertently used the term “health care clinician” and proposed to replace it with the more appropriate term “health care provider”. We proposed this change would apply beginning with the performance period in 2017.
We inadvertently used the term “health care clinician” and proposed to replace it with the more appropriate term “health care provider”. We proposed this change would apply beginning with the 2017 performance period.
We proposed this change because we inadvertently finalized the measure description that we had proposed for Stage 3 of the EHR Incentive Program (80 FR 62866) and not the measure description that we finalized (80 FR 62970). We are modifying the proposed change so that it does align with the measure description finalized for Stage 3 by adding the phrase “from an urgent care setting” to the end of the measure description.
In the proposed rule, we noted that we have split the Specialized Registry Reporting Measure that we adopted under the 2017 Advancing Care Information Transition Objectives and Measures into two separate measures, Public Health Registry Reporting and Clinical Data Registry Reporting, to better define the registries available for reporting. We proposed to allow MIPS eligible clinicians and groups to continue to count active engagement in electronic public health reporting with specialized registries. We proposed to allow these registries to be counted for purposes of reporting the Public Health Registry Reporting Measure or the Clinical Data Registry Reporting Measure beginning with the 2018 performance period. A MIPS eligible clinician may count a specialized registry if the MIPS eligible clinician achieved the phase of active engagement as described under “active engagement option 3: production” in the 2015 EHR Incentive Programs final rule with comment period (80 FR 62862 through 62865), meaning the clinician has completed testing and validation of the electronic submission and is electronically submitting production data to the public health agency or clinical data registry.
In the CY 2017 Quality Payment Program final rule (81 FR 77229 through 77237), we finalized the 2017 Advancing Care Information Transition Objectives and Measures for MIPS eligible clinicians using EHR technology certified to the 2014 Edition. Because we proposed in section II.C.6.f.(4) of the
We proposed to modify this objective beginning with the 2017 performance period by removing the word “electronic” from the description of timely access as it was erroneously included in the final rule (81 FR 77228).
We inadvertently used the term “health care clinician” and proposed to replace it with the more appropriate term “health care provider”. We proposed this change would apply beginning with the performance period in 2017.
We inadvertently used the term “health care clinician” and proposed to replace it with the more appropriate term “health care provider”. We proposed this change would apply beginning with the performance period in 2017.
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We proposed to modify the numerator by removing medication list, medication allergy list, and current problem list. These three criteria were adopted for Stage 3 (80 FR 62862) but not for Modified Stage 2 (80 FR 62811). We proposed this change would apply beginning with the performance period in 2017.
The following is a summary of the public comments received on the “Advancing Care Information Objectives and Measures” and the “2017 and 2018 Advancing Care Information Transition Objectives and Measures” proposals and our responses:
To facilitate readers in identifying the requirements of CEHRT for the Advancing Care Information Objectives and Measures, we are including the Table 9, which includes the 2015 Edition and 2014 Edition certification criteria required to meet the objectives and measures.
We proposed to add exclusions to the measures associated with the Health Information Exchange and Electronic Prescribing Objectives required for the base score, as described below. We proposed these exclusions would apply beginning with the CY 2017 performance period.
We note that we finalized our proposal to replace “health care clinician” with “health care provider” in the objective and measure.
We note that we finalized our proposal to replace “health care clinician” with “health care provider” in the objective and measure.
The following is a summary of the public comments received on these proposals and our responses:
As we noted in the CY 2017 Quality Payment Program final rule (81 FR 77238), 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, on a case-by-case basis, exempt an EP from the application of the payment adjustment under section 1848(a)(7)(A) of the Act if the Secretary determines, subject to annual renewal, that compliance with the requirement 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 last sentence of section 1848(a)(7)(B) of the Act also provides that in no case may an exemption be granted under subparagraph (B) for more than 5 years. The MACRA did not maintain these statutory exceptions for the advancing care information performance category of the MIPS. Thus, we had previously stated that the provisions 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.
Following the publication of the CY 2017 Quality Payment Program final rule, the 21st Century Cures Act (Pub. L. 114-255) was enacted on December 13, 2016. Section 4002(b)(1)(B) of the 21st Century Cures Act amended section 1848(o)(2)(D) of the Act to state that the provisions of sections 1848(a)(7)(B) and (D) of the Act shall apply to assessments of MIPS eligible clinicians under section 1848(q) of the Act with respect to the performance category described in subsection (q)(2)(A)(iv) (the advancing care information performance category) in an appropriate manner which may be similar to the manner in which such provisions apply with respect to the meaningful use payment adjustment made under section 1848(a)(7)(A) of the Act. As a result of this legislative change, we believe that the general exceptions described under sections 1848(a)(7)(B) and (D) of the Act are applicable under the MIPS program. We included the proposals described below to implement these provisions as applied to assessments of MIPS eligible clinicians under section 1848(q) of the Act with respect to the advancing care information performance category.
In the CY 2017 Quality Payment Program final rule (81 FR 77240 through 77243), we recognized that there may not be sufficient measures applicable and available under the advancing care information performance category to MIPS eligible clinicians facing a significant hardship, such as those who lack sufficient internet connectivity, face extreme and uncontrollable circumstances, lack control over the availability of CEHRT, or do not have face-to-face interactions with patients. We relied on section 1848(q)(5)(F) of the Act to establish a final policy to assign a zero percent weighting to the advancing care information performance category in the final score if there are not sufficient measures and activities applicable and available to MIPS eligible clinicians within the categories of significant hardship noted above (81 FR 77243). Additionally, under the final policy (81 FR 77243), we did not impose a limitation on the total number of MIPS payment years for which the advancing
We did not propose substantive changes to this policy; however, as a result of the changes in the law made by the 21st Century Cures Act discussed above, we will not rely on section 1848(q)(5)(F) of the Act and instead proposed to use the authority in the last sentence of section 1848(o)(2)(D) of the Act for significant hardship exceptions under the advancing care information performance category under MIPS. Section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act, states in part that the provisions of section 1848(a)(7)(B) of the Act shall apply to assessments of MIPS eligible clinicians with respect to the advancing care information performance category in an appropriate manner which may be similar to the manner in which such provisions apply with respect to the payment adjustment made under section 1848(a)(7)(A) of the Act. We would assign a zero percent weighting to the advancing care information performance category in the MIPS final score for a MIPS payment year for MIPS eligible clinicians who successfully demonstrate a significant hardship through the application process. We would use the same categories of significant hardship and application process as established in the CY 2017 Quality Payment Program final rule (81 FR 77240-77243). We would automatically reweight the advancing care information performance category to zero percent for a MIPS eligible clinician who lacks face-to-face patient interaction and is classified as a non-patient facing MIPS eligible clinician without requiring an application. If a MIPS eligible clinician submits an application for a significant hardship exception or is classified as a non-patient facing MIPS eligible clinician, but also reports on the measures specified for the advancing care information performance category, they would be scored on the advancing care information performance category like all other MIPS eligible clinicians, and the category would be given the weighting prescribed by section 1848(q)(5)(E) of the Act regardless of the MIPS eligible clinician's score.
As required under section 1848(a)(7)(B) of the Act, eligible professionals were not granted significant hardship exceptions for the payment adjustments under the Medicare EHR Incentive Program for more than 5 years. We proposed not to apply the 5-year limitation under section 1848(a)(7)(B) of the Act to significant hardship exceptions for the advancing care information performance category under MIPS.
We solicited comments on the proposed use of the authority provided in the 21st Century Cures Act in section 1848(o)(2)(D) of the Act as it relates to application of significant hardship exceptions under MIPS and the proposal not to apply a 5-year limit to such exceptions.
The following is a summary of the public comments received on these proposals and our responses:
Section 1848(q)(2)(B)(iii) of the Act requires the Secretary to give consideration to the circumstances of small practices (consisting of 15 or fewer professionals) and practices located in rural areas and geographic HPSAs in establishing improvement activities under MIPS. In the CY 2017 Quality Payment Program final rule (81 FR 77187 through 77188), we finalized that for MIPS eligible clinicians and groups that are in small practices or located in rural areas, or geographic health professional shortage areas (HPSAs), to achieve full credit under the improvement activities category, one high-weighted or two medium-weighted improvement activities are required.
While there is no corresponding statutory provision for the advancing care information performance category, we believe that special consideration should also be available for MIPS eligible clinicians in small practices. We proposed a significant hardship exception for the advancing care information performance category for MIPS eligible clinicians who are in small practices, under the authority in section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act (see discussion of the statutory authority for significant hardship exceptions in section II.C.6.f.(7)(ii) of the proposed rule). We proposed that this hardship exception would be available to MIPS eligible clinicians in small practices as defined under § 414.1305. We proposed in section II.C.1.e. of the proposed rule, that CMS would make eligibility determinations regarding the size of small practices for performance periods occurring in 2018 and future years. We proposed to reweight the advancing care information performance category to zero percent of the MIPS final score for MIPS eligible clinicians who qualify for this hardship exception. We proposed this exception would be available beginning with the 2018 performance period and 2020 MIPS payment year. We proposed a MIPS eligible clinician seeking to qualify for this exception would submit an application in the form and manner specified by us by December 31st of the performance period or a later date specified by us. We also proposed MIPS eligible clinicians seeking this exception must demonstrate in the application that there are overwhelming barriers that prevent the MIPS eligible clinician from complying with the requirements for the advancing care information performance category. In accordance with section 1848(a)(7)(B) of the Act, the exception would be subject to annual renewal. Under the proposal in section II.C.6.f.(7)(a) of the proposed rule, the 5-year limitation under section 1848(a)(7)(B) of the Act would not apply to this significant hardship exception for MIPS eligible clinicians in small practices.
While we would be making this significant hardship exception available to small practices in particular, we are considering whether other categories or types of clinicians might similarly require an exception. We solicited comment on what those categories or types are, why such an exception is required, and any data available to support the necessity of the exception. We noted that supporting data would be particularly helpful to our consideration of whether any additional exceptions would be appropriate.
The following is a summary of the public comments received on these proposals and our responses:
In the CY 2017 Quality Payment Program final rule (81 FR 77238 through 77240), we defined a hospital-based MIPS eligible clinician under § 414.1305 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 discussed our assumption that MIPS eligible clinicians who are determined hospital-based do not have sufficient advancing care information measures applicable to them, and we established a policy to 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 (81 FR 77240).
We did not propose substantive changes to this policy; however, as a result of the changes in the law made by the 21st Century Cures Act discussed above, we will not rely on section 1848(q)(5)(F) of the Act and instead proposed to use the authority in the last sentence of section 1848(o)(2)(D) of the Act for exceptions for hospital-based MIPS eligible clinicians under the advancing care information performance category. Section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act, states in part that the provisions of section 1848(a)(7)(D) of the Act shall apply to assessments of MIPS eligible clinicians with respect to the advancing care information performance category in an appropriate manner which may be similar to the manner in which such provisions apply with respect to the payment adjustment made under section 1848(a)(7)(A) of the Act. We would assign a zero percent weighting to the advancing care information performance category in the MIPS final score for a MIPS payment year for hospital-based MIPS eligible clinicians as previously defined. A hospital-based MIPS eligible clinician would 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 would be scored on the advancing care information performance category like all other MIPS eligible clinicians, and the category would be given the weighting prescribed by section 1848(q)(5)(E) of the Act regardless of their score.
We proposed to amend § 414.1380(c)(1) and (2) of the regulation text to reflect this proposal.
We requested comments on the proposed use of the authority provided in the 21st Century Cures Act in section 1848(o)(2)(D) of the Act as it relates to hospital-based MIPS eligible clinicians.
The following is a summary of the public comments received on these proposals and our responses:
They suggested that CMS adopt a policy whereby if the simple majority of the group's clinicians meet the definition of hospital-based, as individuals, then the group as a whole would be exempt from the advancing care information performance category.
Section 16003 of the 21st Century Cures Act amended section 1848(a)(7)(D) of the Act to provide that no payment adjustment may be made under section 1848(a)(7)(A) of the Act for 2017 and 2018 in the case of an eligible professional who furnishes substantially all of his or her covered professional services in an ambulatory surgical center (ASC). Section 1848(a)(7)(D)(iii) of the Act provides that determinations of whether an eligible professional is ASC-based may be made based on the site of service as defined by the Secretary or an attestation, but shall be made without regard to any employment or billing arrangement between the eligible professional and any other supplier or provider of services. Section 1848(a)(7)(D)(iv) of the Act provides that
Under section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act, the ASC-based provisions of section 1848(a)(7)(D) of the Act shall apply to assessments of MIPS eligible clinicians under section 1848(q) of the Act with respect to the advancing care information performance category in an appropriate manner which may be similar to the manner in which such provisions apply with respect to the payment adjustment made under section 1848(a)(7)(A) of the Act. We believe the proposals for ASC-based MIPS eligible clinicians are an appropriate application of the provisions of section 1848(a)(7)(D) of the Act to MIPS eligible clinicians. Under the Medicare EHR Incentive Program an approved hardship exception exempted an EP from the payment adjustment. We believe that weighting the advancing care information performance category to zero percent is similar in effect to an exemption from the requirements of that performance category.
To align with our hospital-based MIPS eligible clinician policy, we proposed to define at § 414.1305 an ASC-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) code 24 used in the HIPAA standard transaction based on claims for a period prior to the performance period as specified by us. We requested comments on this proposal and solicit comments as to whether other POS codes should be used to identify a MIPS eligible clinician's ASC-based status or if an alternative methodology should be used. We noted that the ASC-based determination will be made independent of the hospital-based determination.
To determine a MIPS eligible clinician's ASC-based status, we proposed 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 would use a 12-month period as close as practicable to this time period. We proposed this timeline to allow us to notify MIPS eligible clinicians of their ASC-based status prior to the start of the performance period and to align with the hospital-based MIPS eligible clinician determination period. For the 2019 MIPS payment year, we would not be able to notify MIPS eligible clinicians of their ASC-based status until after the final rule with comment period is published, which we anticipate would be later in 2017. We expect that we would provide this notification through
For MIPS eligible clinicians who we determine are ASC-based, we proposed to assign a zero percent weighting to the advancing care information performance category in the MIPS final score for the MIPS payment year. However, if a MIPS eligible clinician who is determined ASC-based chooses to report on the Advancing Care Information Measures or the Advancing Care Information Transition Measures, if applicable, for the performance period for the MIPS payment year for which they are determined ASC-based, we proposed they would be scored on the advancing care information performance category like all other MIPS eligible clinicians, and the performance category would be given the weighting prescribed by section 1848(q)(5)(E) of the Act regardless of their advancing care information performance category score.
We proposed these ASC-based policies would apply beginning with the 2017 performance period/2019 MIPS payment year.
We proposed to amend § 414.1380(c)(1) and (2) of the regulation text to reflect these proposals.
The following is a summary of the public comments received on these proposals and our responses:
Section 4002(b)(1)(A) of the 21st Century Cures Act amended section 1848(a)(7)(B) of the Act to provide that the Secretary shall exempt an eligible professional from the application of the payment adjustment under section 1848(a)(7)(A) of the Act with respect to a year, subject to annual renewal, if the Secretary determines that compliance with the requirement for being a meaningful EHR user is not possible because the CEHRT used by such professional has been decertified under ONC's Health IT Certification Program. Section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act, states in part that the provisions of section 1848(a)(7)(B) of the Act shall apply to assessments of MIPS eligible clinicians with respect to the advancing care information performance category in an appropriate manner which may be similar to the manner in which such provisions apply with respect to the
We proposed that a MIPS eligible clinician may demonstrate through an application process that reporting on the measures specified for the advancing care information performance category is not possible because the CEHRT used by the MIPS eligible clinician has been decertified under ONC's Health IT Certification Program. We proposed that if the MIPS eligible clinician's demonstration is successful and an exception is granted, we would assign a zero percent weighting to the advancing care information performance category in the MIPS final score for the MIPS payment year. In accordance with section 1848(a)(7)(B) of the Act, the exception would be subject to annual renewal, and in no case may a MIPS eligible clinician be granted an exception for more than 5 years. We proposed this exception would be available beginning with the CY 2018 performance period and the 2020 MIPS payment year.
We proposed that a MIPS eligible clinician may qualify for this exception if their CEHRT was decertified either during the performance period for the MIPS payment year or during the calendar year preceding the performance period for the MIPS payment year. In addition, we proposed that the MIPS eligible clinician must demonstrate in their application and through supporting documentation if available that the MIPS eligible clinician made a good faith effort to adopt and implement another CEHRT in advance of the performance period. We proposed a MIPS eligible clinician seeking to qualify for this exception would submit an application in the form and manner specified by us by December 31st of the performance period, or a later date specified by us.
We proposed to amend § 414.1380(c)(1) and (2) of the regulation text to reflect these proposals.
The following is a summary of the public comments received on these proposals and our responses:
In the CY 2017 Quality Payment Program final rule (81 FR 77238 through 77240, we defined 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 services 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 proposed to modify our policy to include covered professional services furnished by MIPS eligible clinicians in an off-campus-outpatient hospital (POS 19) in the definition of hospital-based MIPS eligible clinician. POS 19 was developed in 2015 in order to capture the numerous physicians that are paid for a portion of their services in an “off campus-outpatient hospital” versus an on campus-outpatient hospital, (POS 22). We also believe that these MIPS eligible clinicians would not typically have control of the development and maintenance of their EHR systems, just like those who bill using POS 22. We proposed to add POS 19 to our existing definition of a hospital-based MIPS eligible clinician beginning with the performance period in 2018.
The following is a summary of the public comments received on these proposals and our responses:
In any of the situations described in the sections above, we would assign a zero percent weighting to the advancing care information performance category in the MIPS final score for the MIPS payment year if the MIPS eligible clinician meets certain specified requirements for this weighting. We noted that these MIPS eligible clinicians may choose to submit Advancing Care Information Measures or the Advancing Care Information Transition Measures, if applicable; however, 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 their advancing care information performance category score. This policy includes MIPS eligible clinicians choosing to report as part of a group or part of a virtual group.
Groups as defined at § 414.1310(e)(1) are required to aggregate their performance data across the TIN in order for their performance to be assessed as a group (81 FR 77058). Additionally, groups that elect to have their performance assessed as a group will be assessed as a group across all four MIPS performance categories. By reporting as part of a group, MIPS eligible clinicians are subscribing to the data reporting and scoring requirements of the group. We noted that the data submission criteria for groups reporting advancing care information performance category described in the CY 2017 Quality Payment Program final rule (81 FR 77215) state that group data should be aggregated for all MIPS eligible clinicians within the group. This includes those MIPS eligible clinicians who may qualify for a zero percent weighting of the advancing care information performance category due to the circumstances as described above, such as a significant hardship or other type of exception, hospital-based or ASC-based status, or certain types of non-physician practitioners (NPs, PAs, CNSs, and CRNAs). If these MIPS eligible clinicians report as part of a group or virtual group, 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 the group's advancing care information performance category score.
The following is a summary of the public comments received and our responses:
We will take these comments into consideration and may address the issues raised in future rulemaking.
In the CY 2017 Quality Payment Program final rule (81 FR 77240-77243), we established the timeline for the submission of applications to reweight the advancing care information performance category in the MIPS final score to align with the data submission timeline for MIPS. We established 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 us. 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. An application would need to be submitted annually to be considered for reweighting each year.
The Quality Payment Program Exception Application will be used to apply for the following exceptions: Insufficient Internet Connectivity; Extreme and Uncontrollable Circumstances; Lack of Control over the Availability of CEHRT; Decertification of CEHRT; and Small Practice.
We proposed to change the submission deadline for the application as we believe that aligning the data submission deadline with the reweighting application deadline could disadvantage MIPS eligible clinicians. We proposed to change the submission deadline for the CY 2017 performance period to December 31, 2017, or a later date specified by us. We believe this change would help MIPS eligible clinicians by allowing them to learn whether their application is approved prior to the data submission deadline for the CY 2017 performance period, March 31, 2018. We noted that if a MIPS eligible clinician submits data for the advancing care information performance category after an application has been submitted, the data would be scored, the application would be considered voided and the advancing care information performance category would not be reweighted.
We further proposed that the submission deadline for the 2018 performance period will be December 31, 2018, or a later date as specified by us. We believe this would help MIPS eligible clinicians by allowing them to learn whether their application is approved prior to the data submission deadline for the CY 2018 performance period, March 31, 2019.
The following is a summary of the public comments received on these proposals and our responses:
Under section 1848(q)(1)(C)(ii)(1) of the Act, Qualifying APM Participants (QPs) are not MIPS eligible clinicians and are thus excluded from MIPS reporting requirements and payment adjustments. Similarly, under section 1848(q)(1)(c)(ii)(II) of the Act, Partial Qualifying APM Participants (Partial QPs) are also not MIPS eligible clinicians unless they opt to report and be scored under MIPS. All other MIPS eligible clinicians, including those participating in MIPS APMs, are subject to MIPS reporting requirements and payment adjustments unless they are excluded on another basis such as being newly enrolled in Medicare or not exceeding the low volume threshold.
In the CY 2017 Quality Payment Program final rule, we finalized the APM scoring standard, which is designed to reduce reporting burden for participants in certain APMs by minimizing the need for them to make duplicative data submissions for both MIPS and their respective APMs (81 FR 77246 through 77269, 77543). We also sought to ensure that MIPS eligible clinicians in APM Entities that participate in certain types of APMs that assess their participants on quality and cost are assessed as consistently as possible across MIPS and their respective APMs. Given that many APMs already assess their participants on cost and quality of care and require engagement in certain improvement activities, we believe that without the APM scoring standard, misalignments could be quite common between the evaluation of performance under the terms of the APM and evaluation of performance on measures and activities under MIPS.
In the CY 2017 Quality Payment Program final rule, we identified the types of APMs for which the APM scoring standard would apply as MIPS APMs (81 FR 77249). We finalized at § 414.1370(b) that to be a MIPS APM, an APM must satisfy 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; (3) the APM bases payment incentives on performance (either at the APM Entity or eligible clinician level) on cost/utilization and quality measures; and (4) the APM is not either a new APM for which the first performance period begins after the first day of the MIPS performance period for the year or an APM in the final year of operation for which the APM scoring standard is impracticable. We specified that we will post the list of MIPS APMs prior to the first day of the MIPS performance period for each year, though we expect that any new models would likely be announced 2 or more months before the start of the performance period for a year (81 FR 77250). We finalized in our regulations at § 414.1370(b) that for a new APM to be a MIPS APM, its first performance period must start on or before the first day of the MIPS performance period. A list of MIPS APMs is available at
We also note that while it is possible to be both a MIPS APM and an Advanced APM, the criteria for the two are distinct, and a determination that an APM is an Advanced APM does not guarantee that it will be a MIPS APM and vice versa. We refer eligible clinicians to our Web site,
We established in the regulations at § 414.1370(c) that the MIPS performance period under § 414.1320 of our regulations applies for the APM scoring standard.
We finalized that under section § 414.1370(f) of our regulations, for the APM scoring standard, MIPS eligible clinicians will be scored at the APM
In the CY 2018 Quality Payment Program proposed rule, for the APM scoring standard, we proposed to: Amend § 414.1370(e) to add an APM Entity group assessment date for MIPS eligible clinicians in full TIN APMs; continue to weight the cost performance category at zero and, in alignment with that proposal, to not take improvement into account for the cost performance category for 2020 and subsequent years; add the CAHPS for ACOs survey to the list of Shared Savings Program and Next Generation ACO Model quality measures that are used to calculate the MIPS APM quality performance category score beginning with the 2018 performance period; define “Other MIPS APMs” under § 414.1305; establish a separate MIPS APM list of quality measures for each Other MIPS APM and use that list for scoring in the quality performance category; calculate the MIPS quality performance category score for Other MIPS APMs using the APM-specific quality measures and score only those measures that are tied to payment as described under the terms of the APM, are available for scoring near the close of the MIPS submission period, have a minimum of 20 cases available for reporting and have an available benchmark; and add scoring for quality improvement to the MIPS APM quality performance category for all MIPS APMs beginning in 2018. We also proposed a quality scoring methodology for Other MIPS APMs beginning in the 2018 MIPS performance period and described the scoring methodology for quality improvement for Other MIPS APMs. We proposed to align the MIPS performance category weights for Other MIPS APMs with those used for Web Interface reporter APMs under the APM scoring standard; and proposed policies to address situations where a MIPS eligible clinician qualifies for reweighting to zero percent in the advancing care information performance category. We also proposed, beginning with the 2018 performance period, to provide MIPS eligible clinicians scored using the APM scoring standard with performance feedback as specified under section 1848(q)(12) of the Act for the quality, advancing care information, and improvement activities performance categories to the extent data are available (82 FR 30080 through 30091). We discuss these final policies in this section of this final rule with comment period.
In reviewing these proposals, we reminded readers that the APM scoring standard is built upon regular MIPS but provides for special policies to address the unique circumstances of MIPS eligible clinicians who are in APM Entities participating in MIPS APMs. For the cost, improvement activities, and advancing care information performance categories, unless a separate policy has been established or is being proposed for the APM scoring standard, the generally applicable MIPS policies would be applicable to the APM scoring standard. Additionally, unless we included a proposal to adopt a unique policy for the APM scoring standard, we proposed to adopt the same generally applicable MIPS policies proposed elsewhere in the CY 2018 Quality Payment Program proposed rule and would treat the APM Entity group as the group for purposes of MIPS. For the quality performance category, however, the APM scoring standard we proposed is presented as a separate, unique standard, and therefore, generally applicable MIPS policies would not be applied to the quality performance category under the APM scoring standard unless specifically stated. We sought comment on whether there may be potential conflicts or inconsistencies between the generally applicable MIPS policies and those proposed under the APM scoring standard, particularly where these could impact our goals to reduce duplicative and potentially incongruous reporting requirements and performance evaluations that could undermine our ability to test or evaluate MIPS APMs, or whether certain generally applicable MIPS policies should be made explicitly applicable to the APM scoring standard.
In the CY 2017 Quality Payment Program final rule, we specified in our regulations at § 414.1370(e) that the APM Entity group for purposes of scoring under the APM scoring standard is determined in the manner prescribed at § 414.1425(b)(1), which provides that eligible clinicians who are on a Participation List on at least one of three dates (March 31, June 30, and August 31) would be considered part of the APM Entity group. Under these regulations, MIPS eligible clinicians who are not on a Participation List on one of these three assessment dates are not scored under the APM scoring standard. Instead, they would need to submit data to MIPS through one of the MIPS data submission mechanisms and their performance would be assessed either as individual MIPS eligible clinicians or as a group according to the generally applicable MIPS criteria.
We stated that we will continue to use the three assessment dates of March 31, June 30, and August 31 to identify MIPS eligible clinicians who are on an APM Entity's Participation List and determine the APM Entity group that is used for purposes of the APM scoring standard (82 FR 30081). In addition, beginning in the 2018 performance period, we proposed to add a fourth assessment date of December 31 to identify those MIPS eligible clinicians who participate in a full TIN APM. We proposed to define full TIN APM at § 414.1305 to mean an APM where participation is determined at the TIN level, and all eligible clinicians who have assigned their billing rights to a participating TIN are therefore participating in the APM. An example of a full TIN APM is the Shared Savings Program, which requires all individuals and entities that have reassigned their right to receive Medicare payment to the TIN of an ACO participant to participate in the ACO and comply with the requirements of the Shared Savings Program.
If an eligible clinician elects to reassign their billing rights to a TIN participating in a full TIN APM, the eligible clinician is necessarily participating in the full TIN APM. We proposed to add this fourth date of December 31 only for MIPS eligible clinicians in a full TIN APM, and only for purposes of applying the APM scoring standard. We did not propose to use this additional assessment date of December 31 for purposes of QP
We proposed to use this fourth assessment date of December 31 to extend the APM scoring standard to only those MIPS eligible clinicians participating in MIPS APMs that are full TIN APMs, ensuring that a MIPS eligible clinician who joins the full TIN APM between August 31 and December 31 in the performance period would be scored under the APM scoring standard. We considered proposing to use the fourth assessment date more broadly for all MIPS APMs. However, we noted that we believe that approach would have allowed MIPS eligible clinicians to inappropriately leverage the fourth assessment date to avoid reporting and scoring under the generally applicable MIPS scoring standard when they were part of the MIPS APM for only a very limited portion of the performance period. That is, for MIPS APMs that allow split TIN participation, we were concerned that it would be possible for MIPS eligible clinicians to briefly join a MIPS APM principally in order to benefit from the APM scoring standard, despite having limited opportunity to contribute to the APM Entity's performance in the MIPS APM. In contrast, we believe MIPS eligible clinicians would be less likely to join a full TIN APM principally to avail themselves of the APM scoring standard, since doing so would require either that the entire TIN join the MIPS APM or the administratively burdensome act of the MIPS eligible clinician reassigning their billing rights to the TIN of an entity participating in the full TIN APM.
We will continue to use only the three dates of March 31, June 30, and August 31 to determine, based on Participation Lists, the MIPS eligible clinicians who participate in MIPS APMs that are not full TIN APMs. We sought comment on the proposed addition of the fourth date of December 31 to assess Participation Lists to identify MIPS eligible clinicians who participate in MIPS APMs that are full TIN APMs for purposes of the APM scoring standard.
The following is a summary of the public comments received on this proposal and our responses:
We anticipate that the current snapshot policy will identify the vast majority of MIPS eligible clinicians in MIPS APMs at the first snapshot, and then at subsequent snapshot dates will add those MIPS eligible clinicians who join a MIPS APM later in the year but still have a significant opportunity to contribute to the APM Entity's performance in the MIPS APM. As such, we believe this policy would more appropriately identify MIPS eligible clinicians for purposes of applying the APM scoring standard.
In the CY 2017 Quality Payment Program final rule, we established a scoring standard for MIPS eligible clinicians participating in MIPS APMs to reduce participant reporting burden by reducing the need for MIPS eligible clinicians participating in these types of APMs to make duplicative data submissions for both MIPS and their respective APMs (81 FR 77246 through 77271). In accordance with section 1848(q)(1)(D)(i) of the Act, we finalized a policy under which we assess the performance of a group of MIPS eligible clinicians in an APM Entity that participates in one or more MIPS APMs based on their collective performance as an APM Entity group, as defined in regulations at § 414.1305.
In addition to reducing reporting burden, we sought to ensure that MIPS eligible clinicians in MIPS APMs are not assessed in multiple ways on the same performance activities. Depending on the terms of the particular MIPS APM, we believe that misalignments could be common between the evaluation of performance on quality and cost under MIPS versus under the terms of the APM. We continue to believe that requiring MIPS eligible clinicians in MIPS APMs to submit data, be scored on measures, and be subject to payment adjustments that are not aligned between MIPS and a MIPS APM could potentially undermine the validity of testing or performance evaluation under the APM. We also believe imposition of MIPS reporting requirements would result in reporting activity that provides little or no added value to the assessment of MIPS eligible clinicians, and could confuse these eligible clinicians as to which CMS incentives should take priority over others in designing and implementing care improvement activities.
In the CY 2017 Quality Payment Program final rule, for MIPS eligible clinicians participating in MIPS APMs, we used our authority to waive certain requirements under the statute to reduce the scoring weight for the cost performance category to zero (81 FR 77258, 77262, and 77266). For MIPS APMs authorized under section 1115A of the Act using our authority under section 1115A(d)(1) of the Act, we waived the requirement under section 1848(q)(5)(E)(i)(II) of the Act, which specifies the scoring weight for the cost performance category. Having reduced the cost performance category weight to zero, we further used our authority under section 1115A(d)(1) of the Act to waive 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 MIPS eligible clinicians participating in MIPS APMs (81 FR 77261-77262; 81 FR 77265 through 77266). Similarly, for MIPS eligible clinicians participating in the Shared Savings Program, we used our authority under section 1899(f) of the Act to waive the same requirements of section 1848 of the Act for the MIPS cost performance category (81 FR 77257 through 77258). We finalized this policy because: (1) APM Entity groups are already subject to cost and utilization performance assessment under the 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 the unique APM Entity characteristics such as which and how many eligible clinicians comprise an APM Entity group. 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, measurement of the population identified through the APM must take priority in order to ensure that the goals and the model evaluation associated with the APM are as clear and free of confounding factors as possible. The potential for different, conflicting results across APMs and MIPS assessments may create uncertainty for MIPS eligible clinicians who are attempting to strategically transform their respective practices and succeed under the terms of the APM.
We sought comment on our proposal to continue to waive the weighting of the cost performance category for the 2020 payment year forward (82 FR 30082). The following is a summary of the public comments we received on this proposal and our responses:
Because of the innovative and unique nature of each MIPS APM and the need to maintain flexibility in designing and implementing them, we do not believe it would be appropriate to attempt to conform programmatic elements of APMs to MIPS.
In setting performance standards with respect to measures and activities in each MIPS performance category, section 1848(q)(3)(B) of the Act requires us to consider historical performance standards, improvement, and the opportunity for continued improvement. Section 1848(q)(5)(D)(i)(I) of the Act requires us to introduce the measurement of improvement into performance scores in the cost performance category for MIPS eligible clinicians for the 2020 MIPS Payment Year if data sufficient to measure improvement are available. Section 1848(q)(5)(D)(i)(II) of the Act permits us to take into account improvement in the case of performance scores in other performance categories. Given that we have in effect waivers of the scoring weight for the cost performance category, and of the requirement to specify and use cost measures in calculating the MIPS final score for MIPS eligible clinicians participating in MIPS APMs, and for the same reasons that we initially waived those requirements, we proposed to use our authority under section 1115A(d)(1) of the Act for MIPS APMs authorized under section 1115A of the Act and under section 1899(f) of the Act for the Medicare Shared Savings Program to waive the requirement under section 1848(q)(5)(D)(i)(I) of the Act to take improvement into account for performance scores in the cost performance category beginning with the 2018 MIPS performance period (82 FR 30082).
We sought comment on this proposal. The following is a summary of the public comments we received and our response:
We finalized in the CY 2017 Quality Payment Program final rule that under the APM scoring standard, participants in the Shared Savings Program and Next Generation ACO Model would be assessed for the purposes of generating a MIPS APM quality performance category score based exclusively on quality measures submitted using the CMS Web Interface (81 FR 77256, 77261). We also recognized that ACOs in both the Shared Savings Program and Next Generation ACO Model are required to use the CMS Web Interface to submit data on quality measures, and that the measures they are required to report for 2017 were also MIPS measures for 2017. We finalized a policy to use quality measures and data submitted by the participant ACOs using the CMS Web Interface and MIPS benchmarks for these measures to score quality for MIPS eligible clinicians in these MIPS APMs at the APM Entity level (81 FR 77256, 77261). For these MIPS APMs, which we refer to as CMS Web Interface reporters going forward, we established that quality performance data that are not submitted using the Web Interface, for example, the CAHPS for ACOs survey and claims-based measures, will not be included in the MIPS APM quality performance category score for 2017. We also established a policy, codified at § 414.1370(f)(1), to allow Shared Savings Program participant TINs to report quality on behalf of the TIN in the event that the ACO Entity fails to report quality on behalf of the APM Entity group, and for purposes of scoring under the APM scoring standard to treat such participant TINs as unique APM Entities.
In the CY 2018 Quality Payment Program proposed rule (82 FR 30082 through 30083), we proposed to score the CAHPS for ACOs survey in addition to the CMS Web Interface measures that are used to calculate the MIPS APM quality performance category score for participants in the Shared Savings Program and Next Generation ACO Model, beginning in the 2018 performance period. The CAHPS for ACOs survey is already required in the Shared Savings Program and Next Generation ACO Model, and including the CAHPS for ACOs survey would better align the measures on which
We did not initially propose to include the CAHPS for ACOs survey as part of the MIPS APM quality performance category scoring for the Shared Savings Program and Next Generation ACO Model because we believed that the CAHPS for ACOs survey would not be collected and scored in time to produce a MIPS quality performance category score. However, operational efficiencies have recently been introduced that have made it possible to score the CAHPS for ACOs survey on the same timeline as the CAHPS for MIPS survey. Under the proposal, the CAHPS for ACOs survey would be added to the total number of quality performance category measures available for scoring in these MIPS APMs.
While the CAHPS for ACOs survey is new to the APM scoring standard, the CG-CAHPS survey upon which it is based is also the basis for the CAHPS for MIPS survey, which was included on the MIPS final list for the 2017 performance period. For further discussion of the CAHPS for ACOs survey, and the way it will be scored, we refer readers to section II.C.7.a.(2)(b) of this final rule with comment period, which describes the CAHPS for MIPS survey and the scoring method that will be used for MIPS and the APM scoring standard in the 2018 performance period.
We noted that although each question in the CAHPS for ACOs survey can also be found in the CAHPS for MIPS survey, the CAHPS for ACOs survey will have one fewer survey question in the Summary Survey Measure entitled “Between Visit Communication”, which has never been a scored measure in the CAHPS for ACOs survey used in the Shared Savings Program or Next Generation ACO Model, and which we believe to be inappropriate to score for MIPS, as it is not scored under the terms of the APM.
We sought comment on this proposal. The following is a summary of the public comments we received and our responses:
We refer readers to section II.C.7.a.(2) of this final rule with comment period for a summary of our final policies related to calculating the MIPS quality performance category percent score for MIPS eligible clinicians, including APM Entity groups, reporting through the CMS Web Interface, and a discussion of our proposed and final changes to those policies for the 2018 performance period. The changes we are finalizing in section II.C.7.a.(2) of this final rule with comment period apply in the same
However, we proposed not to subject Web Interface reporters to a 3 point floor because we do not believe it is necessary to apply this transition year policy to MIPS eligible clinicians participating in previously established MIPS APMs (82 FR 30083). We sought comment on this proposal.
In the CY 2017 Quality Payment Program final rule, we finalized that for CMS Web Interface reporters, we will apply bonus points based on the finalized set of measures reportable through the Web Interface (81 FR 77291 through 77294). We will assign two bonus points for reporting each outcome measure (after the first required outcome measure) and for each scored patient experience measure. We will also assign one bonus point for reporting each other high priority measure.
In the CY 2018 Quality Payment Program proposed rule (82 FR 30083), we noted that in addition to the measures required by the APM to be submitted through the CMS Web Interface, APM Entities in the Medicare Shared Savings Program and Next Generation ACO Model must also report the CAHPS for ACOs survey, and we proposed that, beginning for the 2020 payment year forward, participants in the APM Entities may receive bonus points under the APM scoring standard for submitting that measure. Participants in MIPS APMs, like all MIPS eligible clinicians, are also subject to the 10 percent cap on bonus points for reporting high priority measures. APM Entities reporting through the CMS Web Interface will only receive bonus points if they submit a high priority measure with a performance rate that is greater than zero, and provided that the measure meets the case minimum requirements.
Beginning in the 2018 performance period, section 1848(q)(5)(D)(i)(I) of the Act requires us to score improvement for the MIPS quality performance category for MIPS eligible clinicians, including those participating in MIPS APMs, if data sufficient to measure quality improvement are available. We proposed to calculate the quality improvement score using the methodology described in the CY 2018 Quality Payment Program proposed rule for scoring quality improvement for MIPS eligible clinicians submitting quality measures via the CMS Web Interface (82 FR 30113, 30116-30119) and finalized at II.C.7.a.(2). In the CY 2018 Quality Payment Program proposed rule, we stated that we believe aligning the scoring methodology used for all Web Interface submissions will minimize confusion among MIPS eligible clinicians receiving a MIPS score, including those participating in MIPS APMs (82 FR 30083).
The following is a summary of the public comments we received on this proposal and our response:
In the 2018 Quality Payment Program proposed rule (82 FR 30083 through 30084), we proposed to calculate the total quality percent score for APM Entities in APMs that require Web Interface reporting according to the methodology for scoring MIPS eligible clinicians reporting on quality through the CMS Web Interface described in section II.C.7.a.(2) of this final rule with comment period.
We sought comment on our proposed quality performance category scoring methodology for Web Interface reporters. The following is a summary of the public comments we received and our responses:
In the CY 2018 Quality Payment Program proposed rule (82 FR 20084), we proposed to define the term Other MIPS APM at § 414.1305 of our regulations as a MIPS APM that does not require reporting through the Web Interface. We proposed to add this definition as we believe it will be useful in discussing our policies for the APM scoring standard. For the 2018 MIPS performance period, Other MIPS APMs will include the Comprehensive ESRD Care Model, the Comprehensive Primary Care Plus Model (CPC+), and the Oncology Care Model.
We sought comment on this proposal. The following is a summary of the public comments we received on this proposal and our responses:
In the CY 2017 Quality Payment Program final rule, we explained that current MIPS APMs have requirements regarding the number of quality measures and 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 within the structure of the specific MIPS APM. We explained that operational considerations and constraints interfered with our ability to use the quality measure data from some MIPS APMs for the purpose of satisfying MIPS data submission requirements for the quality performance category for the first performance period. We concluded that there was insufficient time to adequately implement changes to the current MIPS APM quality measure data collection timelines and infrastructure in the first performance period to conduct a smooth hand-off to the MIPS system that would enable use of quality measure data from these MIPS APMs to satisfy the MIPS quality performance category requirements in the first MIPS performance period (81 FR 77264). Out of concern that subjecting MIPS eligible clinicians who participate in these MIPS APMs to multiple, potentially duplicative or inconsistent performance assessments could undermine the validity of testing or performance evaluation under the MIPS APMs; and that there was insufficient time to make adjustments in operationally complex systems and processes related to the alignment, submission and collection of APM quality measures for purposes of MIPS, we used our authority under section 1115A(d)(1) of the Act to waive certain requirements of section 1848(q) of the Act for APMs authorized under section 1115A of the Act.
In the CY 2017 Quality Payment Program final rule, we finalized that for the first MIPS performance period only, for MIPS eligible clinicians participating in APM Entities in Other MIPS APMs, the weight for the quality performance category is zero (81 FR 77268). To avoid risking adverse operational or program evaluation consequences for MIPS APMs while we worked toward incorporating MIPS APM quality measures into scoring for future performance periods, we used the authority provided by section 1115A(d)(1) of the Act to waive the quality performance category weight required under section 1848(q)(5)(E)(i)(I) of the Act for Other MIPS APMs, all of which are currently authorized under section 1115A of the Act, and we indicated that with the reduction of the quality performance category weight to zero, it was unnecessary to establish for these MIPS APMs a final list of quality measures as required under section 1848(q)(2)(D) of the Act or to specify and use quality measures in determining the MIPS final score for these MIPS eligible clinicians. As such, we further waived the requirements under sections 1848(q)(2)(D), 1848(q)(2)(B)(i), and 1848(q)(2)(A)(i) of the Act to establish a final list of quality measures (using certain criteria and processes); and to specify and use, respectively, quality measures in calculating the MIPS final score for the first MIPS performance period.
In the CY 2017 Quality Payment Program final rule, we anticipated that beginning with 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 MIPS APMs. We also anticipated that it may be necessary to propose policies and waivers of requirements of the statute, such as section 1848(q)(2)(D) of the Act, to enable the use of non-MIPS quality measures in the quality performance category score. We anticipated that by the second MIPS performance period we would have had sufficient time to resolve operational constraints related to use of separate quality measure systems and to adjust quality measure data submission timelines. Accordingly, we stated our intention, in future rulemaking, to use our section 1115A(d)(1) waiver authority to establish that the quality measures and data that are used to evaluate performance for APM Entities in Other MIPS APMs would be used to calculate a MIPS quality performance score under the APM scoring standard.
We have since designed the means to overcome the operational constraints that prevented us from scoring quality for these MIPS APMs under the APM scoring standard in the first MIPS performance period, and in the CY 2018 Quality Payment Program proposed rule we proposed to adopt quality measures for use under the APM scoring standard, and to begin collecting MIPS APM quality measure performance data to generate a MIPS quality performance category score for APM Entities participating in Other MIPS APMs beginning with the 2018 MIPS performance period.
We sought comment on this proposal. The following is a summary of the public comments we received on this proposal and our responses:
In the CY 2017 Quality Payment Program final rule, we explained the concerns that led us to express our intent to use the quality measures and data that apply in MIPS APMs for purposes of the APM scoring standard, including concerns about the application of multiple, potentially duplicative or inconsistent performance assessments that could negatively impact our ability to evaluate MIPS APMs (81 FR 77246). Additionally, the quality and cost/utilization measures that are used to calculate performance-based payments in MIPS APMs may vary from one MIPS APM to another. Factors such as the type and quantity of measures required, the MIPS APM's particular measure specifications, how frequently the measures must be reported, and the mechanisms used to collect or submit the measures all add to the diversity in the quality and cost/utilization measures used to evaluate performance among MIPS APMs. Given
The MIPS APM measure list we proposed in Table 13 of the CY 2018 Quality Payment Program proposed rule would define distinct measure sets for participants in each MIPS APM for purposes of the APM scoring standard, based on the measures that are used by the APM, and for which data will be collected by the close of the MIPS submission period. The measure sets on the MIPS APM measure list would represent all possible measures which may contribute to an APM Entity's MIPS score for the MIPS quality performance category, and may include measures that are the same as or similar to those used by MIPS. However, measures may ultimately not be used for scoring if a measure's data becomes inappropriate or unavailable for scoring; for example, if a measure's clinical guidelines are changed or the measure is otherwise modified by the APM during the performance period, the data collected during that performance period would not be uniform, and as such may be rendered unusable for purposes of the APM scoring standard (82 FR 30091).
We sought comment on this proposal. The following is a summary of comments we received on this proposal and our responses:
Because the quality measure sets for each Other MIPS APM are unique, in the CY 2018 Quality Payment Program proposed rule, we proposed to calculate the MIPS quality performance category score using Other MIPS APM-specific quality measures (82 FR 30085). For purposes of the APM scoring standard, we proposed to score only measures that: (1) Are tied to payment as described under the terms of the APM, (2) are available for scoring near the close of the MIPS submission period, (3) have a minimum of 20 cases available for reporting, and (4) have an available benchmark. We discuss our policies for each of these requirements for Other MIPS APM quality measures below.
We sought comment on this proposal. The following is a summary of the comments we have received and our responses:
As discussed in the CY 2018 Quality Payment Program proposed rule (82 FR 30085), for purposes of the APM scoring standard, we proposed to consider a measure to be tied to payment if an APM Entity group will receive a payment adjustment or other incentive payment under the terms of the APM, based on the APM Entity's performance on the measure.
We sought comment on this proposal. We did not receive any comments on this proposal.
Some MIPS APM quality measure results are not available until late in the calendar year subsequent to the MIPS performance period, which would prevent us from including them in the MIPS APM quality performance category score under the APM scoring standard due to the larger programmatic timelines for providing MIPS eligible clinician performance feedback by July and issuing budget-neutral MIPS payment adjustments. Consequently, we proposed to only use the MIPS APM quality measure data that are submitted by the close of the MIPS submission period and are available for scoring in time for inclusion to calculate a MIPS quality performance category score (82 FR 30085). Measures are to be submitted according to requirements under the terms of the APM; the measure data will then be aggregated and prepared for submission to MIPS for the purpose of creating a MIPS quality performance category score.
We believe using the Other MIPS APMs' quality measure data that have been submitted no later than the close of the MIPS submission period and have been processed and made available to MIPS for scoring in time to calculate a MIPS quality performance category score is consistent with our intent to decrease duplicative reporting for MIPS eligible clinicians who would otherwise need to report quality measures to both MIPS and their APM. Going forward, these are the measures to which we are referring in our proposal to limit scoring to measures that are available near the close of the MIPS submission period.
We sought comment on this proposal. We did not receive any comments on this proposal.
We also believe that a 20 case minimum, in alignment with the one finalized generally under MIPS in the CY 2017 Quality Payment Program final rule, is necessary to ensure the reliability of the measure data submitted, as we explained the CY 2017 Quality Payment Program final rule (81 FR 77288).
We proposed that when an APM Entity reports a quality measure that includes less than 20 cases, under the APM scoring standard, the measure would receive a null score for that measure's achievement points, and the measure would be removed from both the numerator and the denominator of the MIPS quality performance category percentage. We proposed to apply this policy under the APM scoring standard.
We sought comment on this proposal. The following is a summary of the comments we received on this proposal and our responses:
An APM Entity's achievement score on each quality measure would be calculated in part by comparing the APM Entity's performance on the measure with a benchmark performance score. Therefore, we would need all scored measures to have a benchmark available by the time that the MIPS quality performance category score is calculated in order to make that comparison.
We proposed that, for the APM scoring standard, the benchmark score used for a quality measure would be the benchmark used in the MIPS APM for calculation of the performance based payments, where such a benchmark is available. If the MIPS APM does not produce a benchmark score for a reportable measure that is included on the MIPS APM measures list, we would use the benchmark score for the measure that is used for the MIPS quality performance category generally (outside of the APM scoring standard) for that MIPS performance period, provided the measure specifications for the measure are the same under both the MIPS final list and the APM measures list. If neither the APM nor MIPS has a benchmark available for a reported measure, the APM Entity that reported that measure would receive a null score for that measure's achievement points, and the measure would be removed from both the numerator and the denominator of the quality performance category percentage.
We sought comment on this proposal. The following is a summary of the comments we received on this proposal and our responses:
Eligible clinicians who participate in Other MIPS APMs are subject to specific quality measure reporting requirements within these APMs. To best align with APM design and objectives, in the CY 2018 Quality Payment Program proposed rule, we proposed that the minimum number of required measures to be reported for the APM scoring standard would be the minimum number of quality measures that are required by the MIPS APM and are collected and available in time to be included in the calculation for the APM Entity score under the APM scoring standard. For example, if an Other MIPS APM requires participating APM Entities to report nine of 14 quality measures and the APM Entity fails to submit them by the APM's submission deadline, then for the purposes of calculating an APM Entity quality performance category score, the APM Entity would receive a zero for those measures. An APM Entity that does not submit any APM quality measures by the submission deadline would receive a zero for its MIPS APM quality performance category percent score for the MIPS performance period.
We also proposed that if an APM Entity submits some, but not all of the measures required by the MIPS APM by the close of the MIPS submission period, the APM Entity would receive points for the measures that were submitted, but would receive a score of zero for each remaining measure between the number of measures reported and the number of measures required by the APM that were available for scoring.
For example, if an APM Entity in the above hypothetical MIPS APM submits quality performance data on three of the APM's measures, instead of the required nine, the APM Entity would receive quality points in the APM scoring standard quality performance category percent score for the three measures it submitted, but would receive zero points for each of the six remaining measures that were required under the terms of the MIPS APM. On the other hand, if an APM Entity reports on more than the minimum number of measures required to be reported under the MIPS APM and the measures meet the other criteria for scoring, only the measures with the highest scores, up to the number of measures required to be reported under the MIPS APM, would be counted; however, any bonus points earned by reporting on measures beyond the minimum number of required measures would be awarded.
If a measure is reported but fails to meet the 20 case minimum or does not have a benchmark available, there would be a null score for that measure, and it would be removed from both the numerator and the denominator, so as not to negatively affect the APM Entity's quality performance category score.
We proposed to assign bonus points for reporting high priority measures or measures with end-to-end CEHRT reporting as described for general MIPS scoring in the CY 2017 Quality Payment Program final rule (81 FR 77297 through 77299).
We sought comment on these proposals. The following is a summary of the public comments we received and our response:
An APM Entity's MIPS APM quality score will be calculated by comparing the APM Entity's performance on a given measure with a benchmark performance score. We proposed that the benchmark score used for a quality measure would be the benchmark used by the MIPS APM for calculation of the performance based payments within the APM, if possible, in order to best align the measure performance outcomes between MIPS APMs and MIPS generally. If the MIPS APM does not produce a benchmark score for a reportable measure that will be available at the close of the MIPS submission period, the benchmark score for the measure that is used for the MIPS quality performance category generally for that performance period would be used, provided the measure specifications are the same for both. If neither the APM nor MIPS has a benchmark available for a reported measure, the APM Entity that reported that measure will receive a null score for that measure's achievement points, and the measure will be removed from both the numerator and the denominator of the quality performance category percentage.
We proposed that for measures that are pay-for-reporting or which do not measure performance on a continuum of performance, we will consider these measures to be lacking a benchmark and they will be treated as such. For example, if a MIPS APM only requires that an APM Entity must surpass a threshold and does not measure APM Entities on performance beyond surpassing a threshold, we would not consider such a measure to measure performance on a continuum.
We proposed to score quality measure performance under the APM scoring standard using a percentile distribution, separated by decile categories, as described in the finalized MIPS quality scoring methodology (81 FR 77282 through 77284). For each benchmark, we will calculate the decile breaks for measure performance and assign points based on the benchmark decile range into which the APM Entity's measure performance falls.
We proposed to use a graduated points-assignment approach, where a measure is assigned a continuum of points out to one decimal place, based on its place in the decile. For example, as shown in Table 11, a raw score of 55 percent would fall within the sixth decile of 41.0 percent to 61.9 percent and would receive between 6.0 and 6.9 points.
We sought comment on our proposal. The following is a summary of the public comments received on this proposal and our response:
For the APM scoring standard quality performance category, we proposed that each APM Entity that reports on quality measures would receive between 1 and 10 achievement points for each measure reported that can be reliably scored against a benchmark, up to the number of measures that are required to be reported by the APM (82 FR 30086 through 30087). Because measures that lack benchmarks or 20 reported cases are removed from the numerator and denominator of the quality performance category percentage, it is unnecessary to include a point-floor for scoring of Other MIPS APMs. Similarly, because the quality measures reported by the MIPS APM for MIPS eligible clinicians under the APM scoring standard are required to be submitted to the APM under the terms of the APM, and the MIPS eligible clinicians do not select their APM measures, there will be no cap on topped out measures for MIPS APM participants being scored under the APM scoring standard, which differs from the policy for other MIPS eligible clinicians proposed in the CY 2018 Quality Payment Program proposed rule (82 FR 30101 through 30103).
Beginning in the 2018 MIPS performance period, we proposed that APM Entities in MIPS APMs, like other MIPS eligible clinicians, would be eligible to receive bonus points for the MIPS quality performance category for reporting on high priority measures or measures submitted via CEHRT (for example, end-to-end submission) (82 FR 30109). For each Other MIPS APM, we proposed to identify whether any of their available measures meets the criteria to receive a bonus, and add the bonus points to the quality achievement points. Further, we proposed that the total number of awarded bonus points may not exceed 10 percent of the APM Entity's total available achievement points for the MIPS quality performance category score.
To generate the APM Entity's quality performance category percentage, achievement points would be added to any applicable bonus points, and then divided by the total number of available achievement points, with a cap of 100 percent. For more detail on the MIPS quality performance category percentage score calculation, we refer readers to section II.C.7.a.(2)(j) of this final rule with comment period.
Under the APM scoring standard for Other MIPS APMs, the number of available achievement points would be the number of measures required under the terms of the APM and available for scoring multiplied by ten. If, however, an APM Entity reports on a required measure that fails the 20 case minimum requirement, or for which there is no available benchmark for that performance period, the measure would receive a null score and all points from that measure would be removed from both the numerator and the denominator.
For example, if an APM Entity reports on four out of four measures required to be reported by the MIPS APM, and receives an achievement score of five on each and no bonus points, the APM Entity's quality performance category percentage would be [(5 points × 4 measures) + 0 bonus points]/(4 measures × 10 max available points), or 50 percent. If, however, one of those measures failed the 20 case minimum requirement or had no benchmark available, that measure would have a null value and would be removed from both the numerator and denominator to create a quality performance category percentage of [(5 points × 3 measures) + 0 bonus points]/(3 measures × 10 max available points), or 50 percent.
If an APM Entity fails to meet the 20 case minimum on all available APM measures, that APM Entity would have its quality performance category score reweighted to zero, as described below.
We sought comment on these proposals. The following is a summary of the public comments we received and our response:
Beginning in the 2018 MIPS performance period, we proposed to score improvement, as well as achievement in the quality performance category (82 FR 30087).
For the APM scoring standard, we proposed that the quality improvement percentage points would be awarded based on the following formula:
We sought comment on this proposal. The following is a summary of the public comments we received on this proposal and our responses:
We note that we inadvertently described the formula in error in the APM scoring standard section, but provided a cross-reference to the discussion and the correct formula under the general MIPS scoring standard (82 FR 30096). We are correcting the error in this final rule with comment period to clarify and resolve the inconsistency by changing the quality improvement score calculation to the following:
We proposed that the APM Entity's total quality performance category score would be equal to [(achievement points + bonus points)/total available achievement points] + quality improvement score. The APM Entity's total quality performance category score may not exceed 100 percent. We sought comment on the proposed quality performance category scoring methodology for APM Entities participating in Other MIPS APMs. The following is a summary of the public comments we received on this proposal and our response:
As we finalized in the CY 2017 Quality Payment Program final rule, for all MIPS APMs we will assign the same improvement activities score to each APM Entity based on the activities involved in participation in a MIPS APM (81 FR 77262 through 77266). As described in the CY 2017 Quality Payment Program final rule, APM Entities will receive a minimum of one half of the total possible points (81 FR 77254). This policy is in accordance with section 1848(q)(5)(C)(ii) of the Act. In the event that the assigned score does not represent the maximum improvement activities score, the APM Entity group will have the opportunity to report additional improvement activities to add points to the APM Entity level score as described in section II.C.6.e. of this final rule with comment period We note that in the 2017 performance year, we determined that the improvement activities involved in participation in all MIPS APMs satisfied the requirements for participating APM entities to receive the maximum score of 100 percent in this performance category. In the 2018 Quality Payment
In the CY 2017 Quality Payment Program final rule, we finalized our policy to attribute one score to each MIPS eligible clinician in an APM Entity group by looking for both individual and group TIN level data submitted for a MIPS eligible clinician and using the highest available score (81 FR 77268). We will then use these scores to create an APM Entity's score based on the average of the highest scores available for all MIPS eligible clinicians in the APM Entity group. If an individual or TIN did not report on the advancing care information performance category, the individual or TIN will contribute a zero to the APM Entity's aggregate score. Each MIPS eligible clinician in an APM Entity group will receive one score, weighted equally with the scores of every other MIPS eligible clinician in the APM Entity group, and we will use these scores to calculate a single APM Entity-level advancing care information performance category score.
As we explained in the CY 2017 Quality Payment Program final rule, under generally applicable MIPS scoring policy, we will assign a weight of zero percent to the advancing care information performance category in the final score for MIPS eligible clinicians who meet specific criteria: Hospital-based MIPS eligible clinicians, MIPS eligible clinicians who are facing a significant hardship, and certain types of non-physician practitioners (NPs, PAs, CRNAs, CNSs) who are MIPS eligible clinicians (81 FR 77238 through 77245). In the CY 2018 Quality Payment Program proposed rule, we proposed to include in this weighting policy ASC-based MIPS eligible clinicians and MIPS eligible clinicians who are using decertified EHR technology (82 FR 30077 through 30078).
In the CY 2018 Quality Payment Program proposed rule, we proposed that under the APM scoring standard, if a MIPS eligible clinician who qualifies for a zero percent weighting of the advancing care information performance category in the final score is part of a TIN reporting at the group level that includes one or more MIPS eligible clinicians who do not qualify for a zero percent weighting, we would not apply the zero percent weighting to the qualifying MIPS eligible clinician, and the TIN would still report on behalf of the entire group, although the TIN would not need to report data for the qualifying MIPS eligible clinician. All MIPS eligible clinicians in the TIN who are participants in the MIPS APM would count towards the TIN's weight when calculating an aggregated APM Entity score for the advancing care information performance category.
If, however, the MIPS eligible clinician is a solo practitioner and qualifies for a zero percent weighting, or if all MIPS eligible clinicians in a TIN qualify for the zero percent weighting, the TIN would not be required to report on the advancing care information performance category, and if the TIN chooses not to report that TIN would be assigned a weight of 0 when calculating the APM Entity's advancing care information performance category score.
If advancing care information data are reported by one or more TIN/NPIs in an APM Entity, an advancing care information performance category score will be calculated for, and will be applicable to, all MIPS eligible clinicians in the APM Entity group. If all MIPS eligible clinicians in all TINs in an APM Entity group qualify for a zero percent weighting of the advancing care information performance category, or in the case of a solo practitioner who comprises an entire APM Entity and qualifies for zero percent weighting, the advancing care information performance category would be weighted at zero percent of the final score, and the advancing care information performance category's weight would be redistributed to the quality performance category.
We sought comment on this proposal. The following is a summary of the public comments we received and our responses:
In the 2018 Quality Payment Program proposed rule, we proposed to continue to use our authority to waive sections 1848(q)(2)(B)(ii) and 1848(q)(2)(A)(ii) of the Act to specify and use, respectively, cost measures, and to maintain the cost performance category weight of zero under the APM scoring standard for the 2018 performance period and subsequent MIPS performance periods (82 FR 30082). Because the cost performance category would be reweighted to zero, that weight would need to be redistributed to other performance categories. We proposed to use our authority under section 1115A(d)(1) to waive requirements under sections 1848(q)(5)(E)(i)(I)(bb), 1848(q)(5)(E)(i)(III) and 1848(q)(5)(E)(i)(IV) of the Act that prescribe the weights, respectively, for the quality, improvement activities, and advancing care information performance categories (82 FR 30088). We proposed to weight the quality performance category score to 50 percent, the improvement activities performance category to 20 percent, and the advancing care information performance category to 30 percent of the final score for all APM Entities in Other MIPS APMs. We proposed these weights to align the Other MIPS APM performance category weights with those assigned to the Web Interface reporters, which we adopted as explained in the CY 2017 Quality Payment Program final rule (81 FR 77262-77263). We believe it is appropriate to align the performance category weights for APM Entities in MIPS APMs that require reporting through the Web Interface with those in Other MIPS APMs. By aligning the performance category weights among all MIPS APMs, we would create greater scoring parity among the MIPS eligible clinicians in MIPS APMs who are being scored under the APM scoring standard.
We sought comment on this proposal. The following is a summary of the comments and our responses:
These final weights are summarized in Table 12.
There could be instances where an Other MIPS APM has no measures available to score for the quality performance category for a MIPS performance period; for example, it is possible that none of the Other MIPS APM's measures would be available for calculating a quality performance category score by or shortly after the close of the MIPS submission period because the measures were removed due to changes in clinical practice guidelines. In addition, as we explained in the CY 2018 Quality Payment Program proposed rule, the MIPS eligible clinicians in an APM Entity may qualify for a zero percent weighting for the advancing care information performance category (82 FR 30087 through 30088). In such instances, under the APM scoring standard, we proposed to reweight the affected performance category to zero, in accordance with section 1848(q)(5)(F) of the Act (82 FR 30088 through 30089).
If the quality performance category is reweighted to zero, we proposed to reweight the improvement activities and advancing care information performance categories to 25 and 75 percent, respectively. If the advancing care information performance category is reweighted to zero, the quality performance category weight would be increased to 80 percent.
We sought comment on these proposals. The following is a summary of the comments on these proposals and our responses:
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.
We did not be create a separate methodology to adjust for patient risk factors for purposes of the APM scoring standard. However, we refer readers to section II.C.7.b.(1)(b) of this final rule with comment period for a description of the complex patient bonus and its application to APM Entities.
We believe an adjustment for eligible clinicians in small practices (referred to herein as the small practice bonus) is appropriate to recognize barriers faced by small practices, such as unique challenges related to financial and other resources, environmental factors, and access to health information technology, and to incentivize eligible clinicians in small practices to participate in the Quality Payment Program and to overcome any performance discrepancy due to practice size.
We refer readers to section II.C.7.b (1)(c) of this final rule with comment period for a discussion of the small practice adjustment and its application to APM Entities.
In the CY 2017 Quality Payment Program final rule, we finalized the methodology for calculating a final score of 0-100 based on the four performance categories (81 FR 77320). We refer readers to section II.C.7.b. of this final rule for a discussion of the changes we are making to the final score methodology. We are codifying our policy pertaining to the calculation of the total APM Entity score at § 414.1370(i).
In the CY 2017 Quality Payment Program final rule, we finalized that all MIPS eligible clinicians scored under
Beginning with the 2018 performance period, we proposed that MIPS eligible clinicians whose MIPS payment adjustment is based on their score under the APM scoring standard will receive performance feedback as specified under section 1848(q)(12) of the Act for the quality, advancing care information, and improvement activities performance categories to the extent data are available for the MIPS performance period (82 FR 30089 through 30090). Further, we proposed that in cases where performance data are not available for a MIPS APM performance category or the MIPS APM performance category has been weighted to zero for that performance period, we would not provide performance feedback on that MIPS performance category.
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 incentives of the APM must take priority over those offered by MIPS in order to ensure that the goals and evaluation associated with the APM are as clear and free of confounding factors as possible. The potential for different, conflicting messages in performance feedback provided by the APMs and that provided by MIPS may create uncertainty for MIPS eligible clinicians who are attempting to strategically transform their respective practices and succeed under the terms of the APM. Accordingly, under sections 1115A(d)(1) and 1899(f) of the Act, for all MIPS performance periods we proposed to waive—for MIPS eligible clinicians participating in MIPS APMs authorized under sections 1115A and 1899 of the Act, respectively—the requirement under section 1848(q)(12)(A)(i)(I) of the Act to provide performance feedback for the cost performance category.
We requested comment on these proposals to waive requirements for performance feedback on the cost performance category beginning in the 2018 performance year, and for the other performance categories in years for which the weight for those categories has been reweighted to zero.
The following is a summary of the public comments we received and our responses:
In summary, we are finalizing the following policies in this section:
• We are finalizing our proposal to define full TIN APM at § 414.1305 and to amend § 414.1370(e) to identify the four assessment dates that would be used to identify the APM Entity group for full TIN APMs for purposes of the APM scoring standard, and to specify that the December 31 date will be used only to identify MIPS eligible clinicians on the APM Entity's Participation List for a MIPS APM that is a full TIN APM in order to add them to the APM Entity group that is scored under the APM scoring standard. We will use this fourth assessment date of December 31 only to extend the APM scoring standard to those MIPS eligible clinicians participating in MIPS APMs that are full TIN APMs, ensuring that a MIPS eligible clinician who joins a full TIN APM late in the performance period would be scored under the APM scoring standard.
• We are finalizing our proposal to continue to weight the cost performance category under the APM scoring standard for Web Interface reporters at zero percent beginning with the 2020 MIPS payment year.
• We are finalizing our proposal not to take improvement into account for performance scores in the cost performance category for Web Interface reporters beginning with the 2020 MIPS payment year to align with our final policy of weighting the cost performance category at zero percent.
• We finalizing our proposal to score the CAHPS for ACOs survey in addition to the Web Interface measures to calculate the MIPS APM quality performance category score for Web Interface reporters (including MIPS eligible clinicians participating in the Shared Savings Program and Next Generation ACO Model), beginning in the 2018 performance period at § 414.1370(e).
• We are finalizing our proposal that, beginning with the 2018 performance period, MIPS eligible clinicians in Web Interface reporters may receive bonus points under the APM scoring standard for submitting the CAHPS for ACOs survey.
• We are finalizing our proposal to calculate the quality improvement score for MIPS eligible clinicians submitting quality measures via the Web Interface using the methodology described in section II.C.7.a.(2) of this final rule with comment period at § 414.1370(g)(1)(i)(B).
• We are finalizing our proposal to calculate the total quality percent score for MIPS eligible clinicians using the Web Interface according to the methodology described in section II.C.7.a.(2) of this final rule with comment period at § 414.1370(g)(1)(i)(C).
• We are finalizing our proposal to establish a separate MIPS APM measure list of quality measures for each Other MIPS APM, which will be the quality measure list used for purposes of the APM scoring standard for that Other MIPS APM.
• We are finalizing our proposals to calculate the MIPS quality performance category score for Other MIPS APMs using MIPS APM-specific quality measures. For purposes of the APM scoring standard, we will score only measures that: (1) Are tied to payment as described under the terms of the APM, (2) are available for scoring near the close of the MIPS submission period, (3) have a minimum of 20 cases available for reporting, and (4) have an available benchmark at § 414.1370(g)(1)(ii)(A)(1) through (4).
• We are finalizing our proposal to only use the MIPS APM quality measure data that are submitted by the close of the MIPS submission period and are available for scoring in time for inclusion to calculate a MIPS quality performance category score.
• We are finalizing our proposal that, for the APM scoring standard, the benchmark score used for a quality measure would be the benchmark used in the MIPS APM for calculation of the performance based payments, where such a benchmark is available. If the APM does not produce a benchmark score for a reportable measure that is included on the APM measures list, we will use the benchmark score for the measure that is used for the MIPS quality performance category generally for that performance period, provided the measure specifications for the measure are the same under both the MIPS final list and the MIPS APM measures list.
• We are finalizing our proposal that the minimum number of quality measures required to be reported for the
• We are finalizing our proposal that the benchmark score used for a quality measure would be the benchmark used by the MIPS APM for calculation of the performance based payments within the APM, if possible, in order to best align the measure performance outcomes between the Quality Payment Program and the APM. We are finalizing our proposal that for measures that are pay-for-reporting or that do not measure performance on a continuum of performance, we will consider these measures to be lacking a benchmark and treat them as such.
• We are finalizing our proposal to score quality measure performance under the APM scoring standard using a percentile distribution, separated by decile categories, as described in the finalized MIPS quality scoring methodology. We are also finalizing our proposal to use a graduated points-assignment approach, where a measure is assigned a continuum of points out to one decimal place, based on its place in the decile.
• We are finalizing our proposal that each APM Entity that reports on quality measures would receive between 1 and 10 achievement points for each measure reported that can be reliably scored against a benchmark, up to the number of measures that are required to be reported by the APM.
• We are finalizing our proposal that MIPS eligible clinicians in APM Entities participating in MIPS APMs, like other MIPS eligible clinicians, would be eligible to receive bonus points for the MIPS quality performance category for reporting on high priority measures or measures submitted via CEHRT. For each Other MIPS APM, we are finalizing our proposal to identify whether any of the available measures meets the criteria to receive a bonus, and add the bonus points to the quality achievement points.
• We are finalizing our proposal to score improvement as well as achievement in the quality performance category beginning in the 2018 performance period at § 414.1370(g)(1)(ii)(B). For the APM scoring standard, the improvement percentage points will be awarded based on the following formula:
• We are finalizing our proposal that the APM Entity's total quality performance category score would be equal to [(achievement points + bonus points)/total available achievement points] + quality improvement score. We are codifying this policy at § 414.1370(g)(1)(ii)(C).
• We are finalizing at § 414.1370(g)(4)(iii), our proposal for scoring the advancing care information performance category if a MIPS eligible clinician who qualifies for a zero percent weighting of the advancing are information performance category. This policy will apply beginning with the 2019 payment year.
• We are finalizing our proposal to maintain the cost performance category weight of zero for all MIPS APMs under the APM scoring standard for the 2020 MIPS payment year and subsequent MIPS payment years. Because the cost performance category will be reweighted to zero, that weight will be redistributed to other performance categories. We are finalizing our policy to align the Other MIPS APM performance category weights with those for Web Interface reporters and weight the quality performance category to 50 percent, the improvement activities performance category to 20 percent, and the advancing care information performance category to 30 percent of the APM Entity final score for all MIPS APMs at § 414.1370(h)(1) through (4).
• We are finalizing our proposal to reweight the quality performance category to zero under the APM scoring standard in instances where none of a MIPS APM's measures will be available for calculating a quality performance category score by or shortly after the close of the MIPS submission period, for example, due to changes in clinical practice guidelines. In addition, the MIPS eligible clinicians in an APM Entity may qualify for a zero percent weighting for the advancing care information performance category.
• We are finalizing our proposal that MIPS eligible clinicians whose MIPS payment adjustment is based on their score under the APM scoring standard will receive performance feedback as specified under section 1848(q)(12) of the Act for the quality, advancing care information, and improvement activities performance categories to the extent data are available for the MIPS performance period. Further, we are finalizing our proposal that in cases where the MIPS APM performance category has been weighted to zero for a performance period, we will not provide performance feedback on that MIPS performance category. We are also finalizing our proposal to waive, using our authority under sections 1115A(d)(1) and 1899(f) of the Act, the requirement under section 1848(q)(12)(A)(i)(I) of the Act to provide performance feedback for the cost performance category for MIPS eligible clinicians participating in MIPS APMs authorized under sections 1115A and 1899 of the Act, respectively; this waiver will be applicable in all years, regardless of the availability of cost performance data for MIPS eligible clinicians participating in these MIPS APMs.
• We are finalizing at section II.C.4.b. of this final rule with comment period to apply the APM scoring standard score when calculating the MIPS payment adjustment for MIPS eligible clinicians participating in MIPS APMs, even for those whose TINs are participating in a virtual group. We are codifying this policy at § 414.1370(f)(2).
• We are not finalizing our proposal to amend § 414.1370(b)(4)(i).
We sought comment on Tables 14, 15, and 16 in the CY 2018 Quality Payment Program proposed rule (82 FR 30091through 30095), which outlined the measures being introduced for notice and comment, and would serve as the measure set used by participants in the identified MIPS APMs in order to create a MIPS score under the APM scoring standard, as described in section II.C.6.g.(3)(b)(ii) of this final rule with comment period.
The following is a summary of the public comments we received and our responses:
For the 2020 MIPS payment year, we intend to build on the scoring methodology we finalized for the transition year, which allows for accountability and alignment across the performance categories and minimizes burden on MIPS eligible clinicians, while continuing to prepare MIPS eligible clinicians for the performance threshold required for the 2021 MIPS payment year. Our rationale for our scoring methodology continues to be grounded in the understanding that the MIPS scoring system has many components and numerous moving parts.
As we continue to move forward in implementing the MIPS program, we strive to balance the statutory requirements and programmatic goals with the ease of use, stability, and meaningfulness for MIPS eligible clinicians, while also emphasizing simplicity and scoring that is understandable for MIPS eligible clinicians. We proposed refinements to the performance standards, the methodology for determining a score for each of the four performance categories (the “performance category score”), and the methodology for determining a final score based on the performance category scores (82 FR 30140 through 30142).
We intended to continue the transition of MIPS by proposing the following policies:
• Continuation of many transition year scoring policies in the quality performance category, with an adjustment to the number of achievement points available for measures that fail to meet the data completeness criteria, to encourage MIPS eligible clinicians to meet data completeness while providing an exception for small practices;
• An improvement scoring methodology that rewards MIPS eligible clinicians who improve their performance in the quality and cost performance categories;
• A new scoring option for the quality and cost performance categories that allows facility-based MIPS eligible clinicians to be scored based on their facility's performance;
• Special considerations for MIPS eligible clinicians in small practices or those who care for complex patients; and
• Policies that allow multiple pathways for MIPS eligible clinicians to receive a neutral to positive MIPS payment adjustment.
We noted that these sets of proposed policies will help clinicians smoothly transition from the transition year to the 2021 MIPS payment year, for which the performance threshold (which represents the final score that would earn a neutral MIPS adjustment) would be either the mean or median (as selected by the Secretary) of the MIPS final scores for all MIPS eligible clinicians from a previous period specified by the Secretary.
Unless otherwise noted, for purposes of this section II.C.7. of the final rule with comment period on scoring, the term “MIPS eligible clinician” will refer to MIPS eligible clinicians that submit data and are scored at either the individual- or group-level, including virtual groups, but will not refer to MIPS eligible clinicians who elect facility-based scoring. The scoring rules for facility-based measurement are discussed in section II.C.7.a.(4) of this final rule with comment period. We also note that the APM scoring standard applies to APM Entities in MIPS APMs, and those policies take precedence where applicable; however, where those policies do not apply, scoring for MIPS eligible clinicians as described in section II.C.7. of this final rule with comment period will apply. We refer readers to section II.C.6.g. of this final rule with comment period for additional information about the APM scoring standard.
The policies for scoring the 4 performance categories are described in detail in section II.C.7.a. of this final rule with comment period. However, as the 4 performance categories collectively create a single MIPS final score, there are several policies that apply across categories, which we discuss in section II.C.7.a.(1) of this final rule with comment period.
In accordance with section 1848(q)(3) of the Act, in the CY 2017 Quality Payment Program final rule, we finalized performance standards for the four performance categories. We refer readers to the CY 2017 Quality Payment Program final rule for a description of the performance standards against which measures and activities in the four performance categories are scored (81 FR 77271 through 77272).
As discussed in the proposed rule (82 FR 30096 through 30098), we proposed to add an improvement scoring standard to the quality and cost performance categories starting with the 2020 MIPS payment year.
In accordance with section 1848(q)(5)(D)(i) of the Act, beginning with the 2020 MIPS payment year, 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. In addition, section 1848(q)(3)(B) of the Act provides that the Secretary, in establishing performance standards for measures and activities for the MIPS performance categories, shall consider: Historical performance standards; improvement; and the opportunity for continued improvement. Section 1848(q)(5)(D)(ii) of the Act also provides that achievement may be weighted higher than improvement.
In the CY 2017 Quality Payment Program final rule, we summarized public comments received on the proposed rule regarding potential ways to incorporate improvement into the scoring methodology moving forward, including approaches based on methodologies used in the Hospital VBP Program, the Shared Savings Program, and Medicare Advantage 5-star Ratings Program (81 FR 77306 through 77308). We did not finalize a policy at that time on this topic and indicated we would take comments into account in developing a proposal for future rulemaking.
When considering the applicability of these programs to MIPS, we looked at the approach that was used to measure improvement for each of the programs and how improvement was incorporated into the overall scoring system. An approach that focuses on measure-level comparison enables a more granular assessment of improvement because performance on a specific measure can be considered and compared from year to year. All options that we considered last year use a standard set of measures that do not provide for choice of measures to assess performance; therefore, they are better structured to compare changes in performance based on the same measure from year to year. The aforementioned programs do not use a category-level approach; however, we believe that a category-level approach would provide a broader perspective, particularly in the absence of a standard set of measures, because it would allow for a more flexible approach that enables MIPS eligible clinicians to select measures and data submission mechanisms that can change from year to year and be more appropriate to their practice in a given year.
We believe that both approaches are viable options for measuring improvement. Accordingly, we noted that we believe that an appropriate approach for measuring improvement for the quality performance category and the cost performance category should consider the unique characteristics of each performance category rather than necessarily applying a uniform approach across both performance categories. For the quality performance category, clinicians are offered a variety of different measures which can be submitted by different mechanisms, rather than a standard set of measures or a single data submission mechanism. For the cost performance category, however, clinicians are scored on the same set of cost measures to the extent each measure is applicable and available to them; clinicians cannot choose which cost measures they will be scored on. In addition, all of the cost measures are derived from administrative claims data with no additional submission required by the clinician.
When considering the applicability of these programs to MIPS, we also considered how scoring improvement is incorporated into the overall scoring system, including when only achievement or improvement is incorporated into a final score or when improvement and achievement are both incorporated into a final score.
We refer readers to the proposed rule (82 FR 30096 through 30098) where we considered how we might adapt for MIPS the various approaches used for scoring improvement under the Hospital VBP Program, Medicare Shared Savings Program, and Medicare Advantage 5-Star rating.
We proposed two different approaches for scoring improvement from year to year. We proposed to measure improvement at the performance category level for the quality performance category score (82 FR 30113 through 30114) and refer readers to section II.C.7.a.(2)(i) of this final rule with comment period for a summary of the comments we received and our responses. Because clinicians can elect the submission mechanisms and quality measures that are most
We noted our belief that there is reason to adopt a different methodology for scoring improvement for the cost performance category from that used for the quality performance category. In contrast to the quality performance category, for the cost performance category, MIPS eligible clinicians do not have a choice in measures or submission mechanisms; rather, all MIPS eligible clinicians are assessed on all measures based on the availability and applicability of the measure to their practice, and all measures are derived from administrative claims data. Therefore, for the cost performance category, we proposed to measure improvement at the measure level (82 FR 30121). We also noted that we are statutorily required to measure improvement for the cost performance category beginning with the second MIPS payment year if data sufficient to measure improvement is available. Because we had proposed to weight the cost performance category at zero percent for the 2018 MIPS performance period/2020 MIPS payment year (82 FR 30047 through 30048), the improvement score for the cost performance category would not have affected the MIPS final score for the 2018 MIPS performance period/2020 MIPS payment year and would have been for informational purposes only. However, as discussed in section II.C.6.d.(2) of this final rule with comment period, we are adopting our alternative option to maintain a 10 percent weight for the cost performance category, and therefore, the cost improvement score will be reflected in the cost performance category percent score and the final score for the 2018 MIPS performance period/2020 MIPS payment year.
We did not propose to score improvement in the improvement activities performance category or the advancing care information performance category at this time, though we may address improvement scoring for these performance categories in future rulemaking.
We proposed to amend § 414.1380(a)(1)(i) to add that improvement scoring is available for the quality performance category and for the cost performance category at § 414.1380(a)(1)(ii) beginning with the 2020 MIPS payment year.
We solicited public comment on our proposals to score improvement for the quality and cost performance categories starting with the 2020 MIPS payment year.
The following is a summary of the public comments received on our proposals and our responses:
Section 1848(q)(5)(D)(i) of the Act requires us to measure improvement for the quality and cost performance categories of MIPS if data sufficient to measure improvement are available, which we interpret to mean that we would measure improvement when we can identify data from a current performance period that can be compared to data from a prior performance period or data that compares performance from year to year. We proposed that we would measure improvement for the quality performance category when data is available because there is a performance category score for the prior performance period (82 FR 30114 through 30116). We also proposed that we would measure improvement for the cost performance category when data is available which is when there is sufficient case volume to provide measurable data on measures in subsequent years with the same identifier (82 FR 30121). We refer readers to sections II.C.7.a.(2)(i)(ii) and II.C.7.a.(3)(a)(i) of this final rule with comment period for details on these proposals, the comments received and our responses, and final policies.
The quality and cost performance categories rely on measures that use detailed measure specifications that include ICD-10-CM/PCS (“ICD-10”) code sets. We annually issue new ICD-10 coding updates, which are effective from October 1 through September 30 (
To provide scoring flexibility for MIPS eligible clinicians and groups for measures impacted by ICD-10 coding changes in the final quarter of the Quality Payment Program performance period—which may render the measures no longer comparable to the historical benchmark—we proposed in the CY 2018 Quality Payment Program proposed rule (82 FR 30098) to codify at §§ 414.1380(b)(1)(xviii) that we will assess performance on measures considered significantly impacted by ICD-10 updates based only on the first 9 months of the 12-month performance period (for example, January 1, 2018 through September 30, 2018, for the 2018 MIPS performance period). As discussed in the CY 2018 Quality Payment Program proposed rule (82 FR 30098), we believed it would be appropriate to assess performance for significantly impacted measures based on the first 9 months of the performance period, rather than the full 12 months because the indicated performance for the last quarter could be affected by the coding changes rather than actual differences in performance. We noted that performance on measures that are not significantly impacted by changes to ICD-10 codes would continue to be assessed on the full 12-month performance period (January 1 through December 31) (82 FR 30098).
In the CY 2018 Quality Payment Program proposed rule (82 FR 30098), we noted that any measure that relies on an ICD-10 code which is added, modified, or removed, such as in the measure numerator, denominator, exclusions, or exceptions, could have an impact on the indicated performance on the measure, although the impact may not always be significant. In the CY 2018 Quality Payment Program proposed rule, we proposed an annual review process to analyze the measures that have a code impact and assess the subset of measures significantly impacted by ICD-10 coding changes during the performance period (82 FR 30098). Depending on the data available, we anticipated that our determination as to whether a measure is significantly impacted by ICD-10 coding changes would include these factors: A more than 10 percent change in codes in the measure numerator, denominator, exclusions, and exceptions; clinical guideline changes or new products or procedures reflected in ICD-10 code changes; and feedback on a measure received from measure developers and stewards (82 FR 30098). In the CY 2018 Quality Payment Program proposed rule, we considered an approach where we would consider any change in ICD-10 coding to impact performance on a measure and thus only rely on the first 9 months of the 12-month performance period for such measures; however, we believed such an approach would be too broad and truncate measurement for too many measures where performance may not be significantly affected (82 FR 30098). We believed that our proposed approach would ensure the measures on which individual MIPS eligible clinicians and groups will have their performance assessed are accurate for the performance period and are consistent with the benchmark set for the performance period (82 FR 30098).
We proposed to publish on the CMS Web site which measures are significantly impacted by ICD-10 coding changes and would require the 9-month assessment (82 FR 30098). We proposed to publish this information by October 1st of the performance period if technically feasible, but by no later than the beginning of the data submission period, which is January 2, 2019 for the 2018 MIPS performance period (82 FR 30098).
We requested comment on the proposal to address ICD-10 measures specification changes during the performance period by relying on the first 9 months of the 12-month performance period (82 FR 30098). We also requested comment on potential alternate approaches to address measures that are significantly impacted due to ICD-10 changes during the performance period, including the factors we might use to determine
The following is a summary of the public comments received on these proposals and our responses:
We also acknowledge the concerns raised by commenters about the burden MIPS eligible clinicians may face to revise and revalidate their submissions,
As we finalize this policy for measures significantly impacted by ICD-10 code changes, we are also concerned about instances where clinical guideline changes or other changes to a measure that occur during the performance period may significantly impact a measure and render the measure no longer comparable to the historical benchmark. As such, we seek comment in this final rule with comment period regarding whether we should apply similar scoring flexibility to such measures.
Many comments submitted in response to the CY 2017 Quality Payment Program final rule requested additional clarification on our finalized scoring methodology for the 2019 MIPS payment year. To provide further clarity to MIPS eligible clinicians about the transition year scoring policies, before describing our proposed scoring policies for the 2020 MIPS payment year, we provided a summary of the scoring policies finalized in the CY 2017 Quality Payment Program final rule
In the CY 2017 Quality Payment Program final rule (81 FR 77286 through 77287), we finalized that the quality performance category would be scored by assigning achievement points to each submitted measure, which we refer to in this section of the proposed rule as “measure achievement points.” In the CY 2018 Quality Payment Program proposed rule (82 FR 30098 through 30099), we proposed to amend various paragraphs in § 414.1380(b)(1) to use this term in place of “achievement points.” MIPS eligible clinicians can also earn bonus points for certain measures (81 FR 77293 through 77294; 81 FR 77297 through 77299), which we referred to as “measure bonus points,” and we proposed to amend § 414.1380(b)(1)(xiii) (which we proposed to redesignate as § 414.1380(b)(1)(xiv)
This resulting quality performance category score is a fraction from zero to 1, which can be formatted as a percent; therefore, for this section, we will present the quality performance category score as a percent and refer to it as “quality performance category percent score.” We also proposed to amend § 414.1380(b)(1)(xv) (which we proposed to redesignate as § 414.1380(b)(1)(xvii)) to use this term in place of “quality performance category score.” Thus, the formula for the quality performance category percent score that we will use in this section is as follows:
This is a summary of the public comments received on the changes to the regulatory text and our responses:
In the CY 2017 Quality Payment Program final rule, we finalized that for the quality performance category, an individual MIPS eligible clinician or group that submits data on quality measures via EHR, QCDR, qualified registry, claims, or a CMS-approved survey vendor for the CAHPS for MIPS survey will be assigned measure achievement points for 6 measures (1 outcome or, if an outcome measure is not available, other high priority measure and the next 5 highest scoring measures) as available and applicable, and will receive applicable measure bonus points for all measures submitted that meet the bonus criteria (81 FR 77282 through 77301).
In addition, for groups of 16 or more clinicians who meet the case minimum of 200, we will also automatically score the administrative claims-based all-cause hospital readmission measure as a seventh measure (81 FR 77287). For individual MIPS eligible clinicians and groups for whom the readmission measure does not apply, the denominator is generally 60 (10 available measure achievement points multiplied by 6 available measures). For groups for whom the readmission measure applies, the denominator is generally 70 points.
If we determined that a MIPS eligible clinician has fewer than 6 measures available and applicable, we will score only the number of measures that are available and adjust the denominator accordingly to the total available measure achievement points (81 FR 77291). A description of the validation process to determine measure availability is provided in the proposed rule (82 FR 30108 through 30109).
For the 2019 MIPS payment year, a MIPS eligible clinician that submits quality measure data via claims, EHR, or third party data submission options (that is, QCDR, qualified registry, EHR, or CMS-approved survey vendor for the CAHPS for MIPS survey), can earn between 3 and 10 measure achievement points for quality measures submitted for the performance period of greater than or equal to 90 continuous days during CY 2017. A MIPS eligible clinician can earn measure bonus points (subject to a cap) if they submit additional high priority measures with a performance rate that is greater than zero, and that meet the case minimum and data completeness requirements, or submit a measure using an end-to-end electronic pathway. An individual MIPS eligible clinician that has 6 or more quality measures available and applicable will have 60 total available measure achievement points. An example was provided in Table 17 of the proposed rule (82 FR 30099). We noted that in the CY 2017 Quality Payment Program proposed rule, we proposed that bonus points would be available for high priority 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, data completeness, and has a performance rate greater than zero, because we believed these qualities would allow us to include the measure in future benchmark development (81 FR 28255). Although we received public comments on this policy, responded to those comments, and reiterated this proposal in the CY 2017 Quality Payment Program final rule (81 FR 77292), we would like to clarify that our policy is to assign measure bonus points for high priority measures, even if the measure's achievement points are not included in the total measure achievement points for calculating the quality performance category percent score, as long as the measure has the required case minimum, data completeness, and has a performance rate greater than zero, and
We proposed to amend § 414.1380(b)(1)(xiii)(A) (which we proposed to redesignate as § 414.1380(b)(1)(xiv)(A)) to state that measure bonus points may be included in the calculation of the quality performance category percent score regardless of whether the measure is included in the calculation of the total measure achievement points. We also proposed a technical correction to the second sentence of that paragraph to state that to qualify for high priority measure bonus points, each measure must be reported with sufficient case volume to meet the required case minimum, meet the required data completeness criteria, and not have a zero percent performance rate.
We did not receive any public comments on this proposal.
In the CY 2017 Quality Payment Program final rule, we also finalized scoring policies specific to groups of 25 or more that submit their quality performance measures using the CMS Web Interface (81 FR 77278 through 77306). Although we did not propose to change the basic scoring system that we finalized in the CY 2017 Quality Payment Program final rule for the 2020 MIPS payment year, we noted that we proposed several modifications to scoring the quality performance category, including adjusting scoring for measures that do not meet the data completeness criteria, adding a method for scoring measures submitted via multiple mechanisms, adding a method for scoring selected topped out measures, and adding a method for scoring improvement (82 FR 30100). We also noted that we proposed an additional option for facility-based scoring for the quality performance category (82 FR 30123 through 30132). Further description of these proposals and finalized policies are discussed below.
We did not propose to change the policies on benchmarking finalized in the CY 2017 Quality Payment Program final rule and codified at paragraphs (b)(1)(i) through (iii) of § 414.1380; however, we proposed a technical correction to paragraphs (i) and (ii) to clarify that measure benchmark data are separated into decile categories based on percentile distribution, and that, other than using performance period data, performance period benchmarks are created in the same manner as historical benchmarks using decile categories based on a percentile distribution and that each benchmark must have a minimum of 20 individual clinicians or groups who reported on the measure meeting the data completeness requirement and case minimum case size criteria and performance greater than zero. We referred readers to the discussion at 81 FR 77282 for more details on that policy.
We received no public comments on the proposed technical correction to § 414.1380.
We noted that the proposal to increase the low-volume threshold could have an impact on our MIPS benchmarks because we include MIPS eligible clinicians and comparable APMs that meet our benchmark criteria in our measure benchmarks, which could reduce the number of individual eligible clinicians and groups that meet the definition of a MIPS eligible clinician and contribute to our benchmarks (82 FR 30101). Therefore, we sought feedback on whether we should broaden the criteria for creating our MIPS benchmarks to include PQRS and any data from MIPS, including voluntary reporters, that meet our benchmark performance, case minimum and data completeness criteria when creating our benchmarks.
We thank commenters for their responses on whether we should broaden the criteria for creating our MIPS benchmarks. We will consider them in future rulemaking.
In the CY 2017 Quality Payment Program final rule, we did not stratify benchmarks by practice characteristics, such as practice size, because we did not believe there was a compelling rationale for such an approach, and we believed that stratifying could have unintended negative consequences for the stability of the benchmarks, equity across practices, and quality of care for beneficiaries (81 FR 77282). We noted that we do create separate benchmarks for each of 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 (for measures derived from claims data, such as the all-cause hospital readmission measure) (81 FR 77282). We refer readers to the CY 2018 Quality Payment Program proposed rule for a summary of the comments we received (82 FR 30101).
We did not propose to change our policies related to stratifying benchmarks by practice size for the 2020 MIPS payment year. For many measures, the benchmarks may not need stratification as they are only meaningful to certain specialties and only expected to be submitted by those certain specialists. We further clarified that in the majority of instances our current benchmarking approach only compares like clinicians to like clinicians. We noted that we continue to believe that stratifying by practice size could have unintended negative consequences for the stability of the benchmarks, equity across practices, and quality of care for beneficiaries. However, we sought comment on methods by which we could stratify benchmarks, while maintaining reliability and stability of the benchmarks, to use in developing future rulemaking for future performance and payment years. Specifically, we sought comment on methods for stratifying benchmarks by specialty or by place of service. We also requested comment on specific criteria to consider for stratifying measures, such as how we should stratify submissions by multi-specialty practices or by practices that operate in multiple places of service.
We thank commenters for their suggestions on stratifying benchmarks and measures for creating MIPS benchmarks. We will consider them in future rulemaking.
When we were developing the quality measure benchmarks, we were guided by the principles we used when developing the MIPS unified scoring system (81 FR 28249 through 28250). We sought a 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 also wanted the methodology to be as a simple as possible while providing flexibility for the variety of practice types. Now that we have gone through 1 year of the program, we are asking for comments on how we can improve our quality measure benchmarking methodology. In the CY 2018 Quality Payment Program proposed rule, we requested comments on how we can specifically improve our benchmarking methodology (82 FR 30100 through 30101). For this final rule with comment period, we are requesting comments on whether our methodology has been successful in achieving the goals we aimed to achieve, and, if not,
In the CY 2017 Quality Payment Program final rule, we finalized at § 414.1380(b)(1) that a MIPS quality measure must have a measure benchmark to be scored based on performance. MIPS quality measures that do not have a benchmark (for example, because fewer than 20 MIPS eligible clinicians or groups submitted data that met our criteria to create a reliable benchmark) will not be scored based on performance (81 FR 77286). In the CY 2018 Quality Payment Program proposed rule (82 FR 30101), we did not propose any changes to this policy. We did, however, propose a technical correction to the regulatory text at § 414.1380(b)(1) to delete the term “MIPS” before “quality measure” in the third sentence of that paragraph and to delete the term MIPS before “quality measures” in the fourth sentence of that paragraph because this policy applies to all quality measures, including the measures finalized for the MIPS program and the quality measures submitted through a QCDR that have been approved for MIPS.
We also did not propose to change the policies to score quality measure performance using a percentile distribution, separated by decile categories and assign partial points based on the percentile distribution finalized in the CY 2017 Quality Payment Program final rule and codified at paragraphs (b)(1)(ix), (x), and (xi) of § 414.1380; however, we proposed a technical correction to paragraph (ix) to clarify that measures are scored against measure benchmarks. We referred readers to the discussion at 81 FR 77286 for more details on those policies.
In Table 19 of the proposed rule (82 FR 3010), we provided an example of assigning points for performance based on benchmarks using a percentile distribution, separated by decile categories. We noted that for quality measures for which baseline period data is available, we will publish the numerical baseline period benchmarks with deciles prior to the start of the performance period (or as soon as possible thereafter) (see 81 FR 77282). For quality measures for which there is no comparable data from the baseline period, we will publish the numerical performance period benchmarks after the end of the performance period (81 FR 77282). We will also publish further explanation of how we calculate partial points at
We did not receive public comments on this proposal.
For the 2017 MIPS performance period, we also finalized at § 414.1380(b)(1) a global 3-point floor for each scored quality measure, as well as for the hospital readmission measure (if applicable), such that MIPS eligible clinicians would receive between 3 and 10 measure achievement points for each submitted measure that can be reliably scored against a benchmark, which requires meeting the case minimum and data completeness requirements (81 FR 77286 through 77287). For measures with a benchmark based on the performance period, rather than on the baseline period, we stated that we would continue to assign between 3 and 10 measure achievement points for performance years after the first transition year because it would help to ensure that the MIPS eligible clinicians are protected from a poor performance score that they would not be able to anticipate (81 FR 77282; 81 FR 77287). For measures with benchmarks based on the baseline period, we stated the 3-point floor was for the transition year and that we would revisit the 3-point floor in future years (81 FR 77286 through 77287).
We note, for clarification purposes, that we stated in the CY 2018 Quality Payment Program proposed rule (82 FR 30102) that measures without a benchmark based on the baseline period would be assigned between 3 and 10 measure achievement points for performance years after the first transition year. However, we wanted to clarify that only measures without a benchmark based on the baseline period that later have a benchmark based on the performance period would be assigned between 3 and 10 measure achievement points for performance years after the first transition year. Measures without a benchmark based on the baseline or performance period would receive 3 points.
For the 2018 MIPS performance period, we proposed to again apply a 3-point floor for each measure that can be reliably scored against a benchmark based on the baseline period, and to amend § 414.1380(b)(1) accordingly. We noted that we proposed to score measures in the CMS Web Interface for the Quality Payment Program for which performance is below the 30th percentile (82 FR 30113). We will revisit the 3-point floor for such measures again in future rulemaking.
We invited public comment on this proposal to again apply this 3-point floor for quality measures that can be reliably scored against a baseline benchmark in the 2018 MIPS performance period.
The following is a summary of the public comments received on the floor for quality measures proposal and our responses:
In the CY 2017 Quality Payment Program final rule, we finalized a policy for the CAHPS for MIPS measure, such that each Summary Survey Measure (SSM) will have an individual benchmark, that we will score each SSM individually and compare it against the benchmark to establish the number of points, and the CAHPS score will be the average number of points across SSMs (81 FR 77284).
As described in the CY 2018 Quality Payment Program proposed rule (82 FR 30102), we proposed to remove two SSMs from the CAHPS for MIPS survey, which would result in the collection of
For these reasons, we proposed not to score the “Health Status and Functional Status” SSM and the “Access to Specialists” SSM beginning with the 2018 MIPS performance period. Despite not being suitable for scoring, both SSMs provide important information about patient care. Qualitative work suggests that “Access to Specialists” is a critical issue for Medicare FFS beneficiaries. The survey is also a useful tool for assessing beneficiaries' self-reported health status and functional status, even if this measure is not used for scoring practices' care experiences. Therefore, we believed that continued collection of the data for these two SSMs is appropriate even though we do not propose to score them.
Other than these two SSMs, we proposed to score the remaining 8 SSMs because they have had high reliability for scoring in prior years, or reliability is expected to improve for the revised version of the measure, and they also represent elements of patient experience for which we can measure the effect one practice has compared to other practices participating in MIPS.
We invited comment on our proposal not to score the “Health Status and Functional Status” and “Access to Specialists” SSMs beginning with the 2018 MIPS performance period.
The following is a summary of the public comments received on our proposal to not score “Health Status and Functional Status” and “Access to Specialists” SSMs beginning with the 2018 MIPS performance period:
Table 17 summarizes the newly finalized SSMs included in the CAHPS for MIPS survey and illustrates application of our policy to score only 8 measures.
Section 1848(q)(3)(B) of the Act requires that, in establishing performance standards with respect to measures and activities, we consider, among other things, the opportunity for continued improvement. We finalized in the CY 2017 Quality Payment Program final rule that we would identify topped out process measures as those with a median performance rate of 95 percent or higher (81 FR 77286). For non-process measures we finalized a topped out definition similar to the definition used in the Hospital VBP Program: The truncated coefficient of variation is less than 0.10 and the 75th and 90th percentiles are within 2 standard errors (81 FR 77286). When a measure is topped out, a large majority of clinicians submitting the measure performs at or very near the top of the distribution; therefore, there is little or no room for the majority of MIPS eligible clinicians who submit the measure to improve. We understand that every measure we have identified as topped out may offer room for improvement for some MIPS eligible clinicians; however, we believe asking clinicians to submit measures that we have identified as topped out and measures for which they already excel is an unnecessary burden that does not add value or improve beneficiary outcomes.
Based on 2015 historic benchmark data,
In the CY 2017 Quality Payment Program final rule, we finalized that for the 2019 MIPS payment year, we would score topped out quality measures in the same manner as other measures (81 FR 77286). We finalized that we would not modify the benchmark methodology for topped out measures for the first year that the measure has been identified as topped out, but that we would modify the benchmark methodology for topped out measures beginning with the 2020 MIPS payment year, provided that it is the second year the measure has been identified as topped out. In the CY 2018 Quality Payment Program proposed rule (82 FR 30103 through 30106), we proposed a phased in approach to apply special scoring to topped out measures, beginning with the 2018 MIPS performance period (2020 MIPS payment year), rather than modifying the benchmark methodology for topped out measures as indicated in the CY 2017 Quality Payment Program final rule. We also provided a summary of comments received in response to the CY 2017 Quality Payment Program final rule (82 FR 30103 through 30104) on how topped out measures should be scored provided that it is the second year the measure has been identified as topped out.
In the CY 2018 Quality Payment Program proposed rule (82 FR 30045 through 30047), we proposed a lifecycle for topped out measures by which, after a measure benchmark is identified as topped out in the published benchmark for 2 years, in the third consecutive year it is identified as topped out it will be considered for removal through notice-and-comment rulemaking or the QCDR approval process and may be removed from the benchmark list in the fourth year, subject to the phased in approach described in section II.C.6.c.(2) of this final rule with comment period.
We also stated in the CY 2017 Quality Payment Program final rule that we do not believe it would be appropriate to remove topped out measures from the CMS Web Interface for the Quality Payment Program because the CMS Web Interface measures are used in MIPS and in APMs such as the Shared Savings Program and because we have aligned policies, where possible, with the Shared Savings Program, such as using the Shared Savings Program benchmarks for the CMS Web Interface measures (81 FR 77285). In the CY 2017 Quality Payment Program final rule, we also finalized that MIPS eligible clinicians submitting via the CMS Web Interface must submit all measures included in the CMS Web Interface (81 FR 77116). Thus, if a CMS Web Interface measure is topped out, the CMS Web Interface submitter cannot select other measures. Because of the lack of ability to select measures, we did not propose to apply the proposed special scoring adjustment to topped out measures for CMS Web Interface for the Quality Payment Program (82 FR 30106).
Additionally, because the Shared Savings Program incorporates a methodology for measures with high performance into the benchmark, we noted that we do not believe capping benchmarks from the CMS Web Interface for the Quality Payment Program is appropriate. We finalized in the CY 2017 Quality Payment Program final rule at § 414.1380(b)(1)(ii)(A) to use benchmarks from the corresponding reporting year of the Shared Savings Program. The Shared Savings Program adjusts some benchmarks to a flat percentage when the 60th percentile is equal to or greater than 80.00 percent for individual measures (78 FR 74759 through 74763), and, for other measures, benchmarks are set using flat percentages when the 90th percentile for a measure are equal to or greater than 95.00 percent (79 FR 67925). Thus, we did not propose to apply the topped out measure cap to measures in the CMS Web Interface for the Quality Payment Program.
Starting with the 2019 MIPS performance period, we proposed to apply the special topped out scoring method to all topped out measures, provided it is the second (or more) consecutive year the measure is identified as topped out (82 FR 30103 through 30106). We sought comment on our proposal to apply special topped out scoring to all topped out measures, provided it is the second (or more) consecutive year the measure is identified as topped out. We also sought comment on the proposal not to apply the topped out measure cap to measures in the CMS Web Interface for the Quality Payment Program. We refer readers to section II.C.6.c.(2) of this final rule with comment period for a summary of the comments we received and our responses.
As part of the lifecycle for topped out measures, we also proposed a method to phase in special scoring for topped out measure benchmarks starting with the 2018 MIPS performance period, provided that is the second consecutive year the measure benchmark is identified as topped out in the benchmarks published for the performance period (82 FR 30103 through 30106). This special scoring would not apply to measures in the CMS Web Interface, as explained later in this section. The phased-in approach described in this section represents our first step in methodically implementing special scoring for topped out measures.
We did not propose to remove topped out measures for the 2018 MIPS performance period because we recognize that there are currently a large number of topped out measures and removing them may impact the ability of some MIPS eligible clinicians to submit 6 measures and may impact some specialties more than others. We noted, however, that we proposed a timeline for removing topped out measures in future years (82 FR 30046). We believe this provides MIPS eligible
We noted that because we create a separate benchmark for each submission mechanism available for a measure, a benchmark for one submission mechanism for the measure may be identified as topped out while another submission mechanism's benchmark may not be topped out. The topped out designation and special scoring apply only to the specific benchmark that is topped out, not necessarily every benchmark for a measure. For example, the benchmark for the claims submission mechanism may be topped out for a measure, but the benchmark for the EHR submission mechanisms for that same measure may not be topped out. In this case, the topped out scoring would only apply to measures submitted via the claims submission mechanism, which has the topped out benchmark. We also described that only the submission mechanism that is topped out for the measure would be removed (82 FR 30104).
We proposed to cap the score of topped out measures at 6 measure achievement points. We proposed a 6-point cap for multiple reasons. First, we noted that we believe applying a cap to the current method of scoring a measure against a benchmark is a simple approach that can easily be predicted by clinicians. Second, the cap will create incentives for clinicians to submit other measures for which they can improve and earn future improvement points. Third, considering the proposed topped out measure lifecycle, we believed this cap would only be used for a few years and the simplicity of a cap on the current benchmarks would outweigh more complicated approaches to scoring such as a cluster-based options or applying a cap on benchmarks based on flat-percentage (see 82 FR 30103 through 30104). The rationale for a 6-point cap is that 6 points is the median score for any measure as it represents the start of the 6th decile for performance and represents the spot between the bottom 5 deciles and start of the top 5 deciles.
We believed the proposed capped scoring methodology would incentivize MIPS eligible clinicians to begin submitting non-topped out measures without performing below the median score. This methodology also would not impact scoring for those MIPS eligible clinicians that do not perform near the top of the measure, and therefore, have significant room to improve on the measure. We noted that we may also consider lowering the cap below 6 points in future years, especially if we remove the 3-point floor for performance in future years.
Although we proposed a new methodology for assigning measure achievement points for topped out measures, we did not propose to change the policy for awarding measure bonus points for topped out measures. Topped out measures will still be eligible for measure bonus points if they meet the required criteria. We refer readers to sections II.C.7.a.(2)(f) and II.C.7.a.(2)(g) of this final rule with comment period for more information about measure bonus points.
While we believe it is important to score topped out measures differently because they could have a disproportionate impact on the scores for certain MIPS eligible clinicians and topped out measures provide little room for improvement for the majority of MIPS eligible clinicians who submit them, we also recognize that numerous measure benchmarks are currently identified as topped out, and special scoring for topped out measures could impact some specialties more than others. Therefore, we considered ways to phase in special scoring for topped out measures in a way that will begin to apply special scoring, but would not overwhelm any one specialty and would also provide additional time to evaluate the impact of topped out measures before implementing it for all topped out measures, while also beginning to encourage submission of measures that are not topped out.
We believe the best way to accomplish this is by applying special topped out scoring to a select number of measures for the 2018 MIPS performance period and to then apply the special topped out scoring to all topped out measures for the 2019 MIPS performance period, provided it is the second consecutive year the measure is topped out. We believe this approach allows us time to further evaluate the impact of topped out measures and allows for a methodical way to phase in topped out scoring.
We identified measures we believe should be scored with the special topped out scoring for the 2018 performance period by using the following set criteria, which are only intended as a way to phase in our topped-out measure policy for selected measures and are not necessarily intended to be criteria for use in future policies:
• Measure is topped out and there is no difference in performance between decile 3 through decile 10. We applied this limitation because, based on historical data, there is no room for improvement for over 80 percent of MIPS eligible clinicians that reported on these measures.
• Process measures only because we want to continue to encourage reporting on high priority outcome measures, and the small subset of structure measures was confined to only three specialties.
• MIPS measures only (which does not include measures that can only be reported through a QCDR) given that QCDR measures go through a separate process for approval and because we want to encourage use of QCDRs required by section 1848(q)(1)(E) of the Act.
• Measure is topped out for all mechanisms by which the measure can be submitted. Because we create a separate benchmark for each submission mechanism available for a measure, a benchmark for one submission mechanism for the measure may be identified as topped out while another submission mechanism's benchmark may not be topped out. For example, the benchmark for the claims submission mechanism may be topped out for a measure, but the benchmark for the EHR submission mechanisms for that same measure may not be topped out. We decided to limit our criteria to only measures that were topped out for all mechanisms for simplicity and to avoid confusion about what scoring is applied to a measure.
• Measure is in a specialty set with at least 10 measures, because 2 measures in the pathology specialty set, which only has 8 measures total, would have been included.
Applying these criteria resulted in the 6 measures as listed in Table 18.
We proposed to apply the special topped out scoring method to only the 6 measures in Table 18 for the 2018 MIPS performance period, provided they are again identified as topped out in the benchmarks for the 2018 MIPS performance period. If these measures are not identified as topped out in the benchmarks published for the 2018 MIPS performance period, they will not be scored differently because they would not be topped out for a second consecutive year.
Finally, we proposed to add a new paragraph at § 414.1380(b)(1)(xiii) to codify our proposal for the lifecycle for removing topped out measures. We also proposed to add at § 414.1380(b)(1)(xiii)(A) that for the 2018 MIPS performance period, the 6 measures identified in Table 18 will receive a maximum of 6 measure achievement points, provided that the measure benchmarks are identified as topped out again in the benchmarks published for the 2018 MIPS performance period. We also proposed to add at § 414.1380(b)(1)(xiii)(B) that beginning with the 2019 MIPS performance period, measure benchmarks, except for measures in the CMS Web Interface, that are identified as topped out for two 2 or more consecutive years will receive a maximum of 6 measure achievement points in the second consecutive year it is identified as topped out, and beyond.
We requested comments on our proposal to score topped out measures differently by applying a 6-point cap, provided it is the second consecutive year the measure is identified as topped out. Specifically, we sought feedback on whether 6 points is the appropriate cap or whether we should consider another value. We also sought comment on our proposal to apply special topped out scoring only to the 6 measures identified in Table 18 for the 2018 MIPS performance period. We also sought comment on our proposal to amend the regulatory text to align with these proposed policies.
The following is a summary of the public comments received on the proposal to cap topped out measures at 6-points and our responses:
The following is a summary of the public comments received on the proposal to not apply the topped out measure scoring cap to measures in the CMS Web Interface and our responses:
The following is a summary of the public comments received on the proposal to apply topped out measure policy for the 6 selected measures in Table 18 for the 2018 MIPS performance period and our responses:
We also sought comment on other possible options for scoring topped out measures that would meet our policy goals to encourage clinicians to begin to submit measures that are not topped out while also providing stability for MIPS eligible clinicians. We specifically sought comment on whether the proposed policy to cap the score of topped out measures beginning with the 2019 MIPS performance period should apply to SSMs in the CAHPS for MIPS survey measure or whether there is another alternative policy that could be applied for the CAHPS for MIPS survey measure due to high, unvarying performance within the SSM. We noted that we would like to encourage groups to report the CAHPS for MIPS survey as it incorporates beneficiary feedback.
We thank the commenters for their feedback and will take their suggestions into consideration in future rulemaking.
We did not receive any public comments specific to our proposal to change the regulatory text at § 414.1380(b)(1)(xiii)(A) and § 414.1380(b)(1)(xiii)(B).
Finally, we are finalizing the proposed regulatory text changes with some modifications to reflect the other policies we are finalizing. We are finalizing amendments to § 414.1380(b)(1)(xiii)(A) to read that, for the 2020 MIPS payment year, the 6 measures identified in Table 18 will receive a maximum of 7 measure achievement points, provided that for the applicable submission mechanisms the measure benchmarks are identified as topped out again in the benchmarks
Together the finalized policies for phasing in capped scoring and removing topped out measures are intended to provide an incentive for MIPS eligible clinicians to begin to submit measures that are not topped out while also providing stability by allowing MIPS eligible clinicians who have few alternative measures to continue to receive standard scoring for most topped out measures for an additional year, and not perform below the median score for those 6 measures that receive special scoring. It also provides MIPS eligible clinicians the ability to anticipate and plan for the removal of specific topped out measures, while providing measure developers time to develop new measures. Below is an illustration of the lifecycle for scoring and removing topped out measures based on our newly finalized policies:
•
•
•
•
An example of applying the proposed scoring cap compared to scoring applied for the 2017 MIPS performance period is provided in Table 19.
To help ensure reliable measurement, in the CY 2017 Quality Payment Program final rule (81 FR 77288), we finalized a 20-case minimum for all quality measures except the all-cause hospital readmission measure. For the all-cause hospital readmission measure, we finalized in the CY 2017 Quality Payment Program final rule a 200-case minimum and finalized to apply the all-cause hospital readmission measure only to groups of 16 or more clinicians that meet the 200-case minimum requirement (81 FR 77288). We did not propose any changes to these policies.
For the 2019 MIPS payment year, we finalized in the CY 2017 Quality Payment Program final rule 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 would receive a score of 3 points (81 FR 77288 through 77289). We identified two classes of measures for the transition year. Class 1
We proposed to maintain the policy to assign 3 points for measures that are submitted but do not meet the required case minimum or do not have a benchmark for the 2020 MIPS payment year and amend § 414.1380(b)(1)(vii) accordingly (82 FR 30106 through 30108). We also proposed a change to the policy for scoring measures that do not meet the data completeness requirement for the 2020 MIPS payment year.
To encourage complete reporting, we proposed that in the 2020 MIPS payment year, measures that do not meet data completeness standards will receive 1 point instead of the 3 points that were awarded in the 2019 MIPS payment year. We proposed lowering the point floor to 1 for measures that do not meet data completeness standards for several reasons. First, we want to encourage complete reporting because data completeness is needed to reliably measure quality. Second, unlike case minimum and availability of a benchmark, data completeness is within the direct control of the MIPS eligible clinician. In the future, we intend that measures that do not meet the completeness criteria will receive zero points; however, we believe that during the second year of transitioning to MIPS, clinicians should continue to receive at least 1 measure achievement point for any submitted measure, even if the measure does not meet the data completeness standards.
We are concerned, however, that data completeness may be harder to achieve for small practices. Small practices tend to have small case volume, and missing one or two cases could cause the MIPS eligible clinician to miss the data completeness standard as each case may represent multiple percentage points for data completeness. For example, for a small practice with only 20 cases for a measure, each case is worth 5 percentage points, and if they miss reporting just 11 or more cases, they would fail to meet the data completeness threshold, whereas for a practice with 200 cases, each case is worth 0.5 percentage points towards data completeness, and the practice would have to miss more than 100 cases to fail to meet the data completeness criteria. Applying 1 point for missing data completeness based on missing a relatively small number of cases could disadvantage small practices, which may have additional burdens for reporting in MIPS, although we also recognize that failing to report on 10 or more patients is undesirable. In addition, we know that many small practices may have less experience with submitting quality performance category data and may not yet have systems in place to ensure they can meet the data completeness criteria. Thus, we proposed an exception to the proposed policy for measures submitted by small practices, as defined in § 414.1305. We proposed that these clinicians would continue to receive 3 points for measures that do not meet data completeness.
Therefore, we proposed to revise Class 2 measures to include only measures that cannot be scored based on performance because they do not have a benchmark or do not have at least 20 cases. We also proposed to create Class 3 measures, which are measures that do not meet the data completeness requirement. We proposed that the revised Class 2 measure would continue to receive 3 points. The proposed Class 3 measures would receive 1 point, except if the measure is submitted by a small practice in which case the Class 3 measure would receive 3 points. However, consistent with the policy finalized in the CY 2017 Quality Payment Program final rule, these policies for Class 2 and Class 3 measures would not apply to measures submitted with the CMS Web Interface or administrative claims-based measures. A summary of the proposals is provided in Table 20.
The following is a summary of the public comments received on our proposal for measures that do not meet the case minimum requirement or do not have a benchmark (Class 2 measures) and our responses:
We proposed to amend § 414.1380(b)(1)(vii) to assign 3 points for measures that do not meet the case minimum or do not have a benchmark in the 2020 MIPS payment year, and to assign 1 point for measures that do not meet data completeness requirements, unless the measure is submitted by a small practice, in which case it would receive 3 points (82 FR 30108).
We invited comment on our proposal to assign 1 point to measures that do not meet data completeness criteria, with an exception for measures submitted by small practices.
The following is a summary of the public comments received on the data completeness proposal and our responses:
We did not propose to change the methodology we use to score measures submitted via the CMS Web Interface that do not meet the case minimum, do not have a benchmark, or do not meet the data completeness requirement finalized in the CY 2017 Quality Payment Program final rule and codified at paragraph (b)(1)(viii) of § 414.1380. We referred readers to the discussion at 81 FR 77288 for more details on our previously finalized policy. However, we noted that as described in the proposed rule (82 FR 30113), we proposed to add that CMS Web Interface measures with a benchmark that are redesignated from pay for performance to pay for reporting by the Shared Savings Program will not be scored. We refer readers to the discussion at section II.C.7.a.(2)(h)(ii) of this final rule with comment period for public comments related to changes in CMS Web Interface scoring.
We also did not propose any changes to the policy to not include administrative claims measures in the quality performance category percent score if the case minimum is not met or if the measure does not have a benchmark finalized in the CY 2017 Quality Payment Program final rule and codified at paragraph (b)(1)(viii) of § 414.1380. We referred readers to the discussion at 81 FR 77288 for more details on that policy.
To clarify the exclusion of measures submitted via the CMS Web Interface and based on administrative claims from the policy changes proposed to be codified at paragraph (b)(1)(vii) previously, we proposed to amend paragraph (b)(1)(vii) to make it subject to paragraph (b)(1)(viii), which codifies the exclusion.
We did not receive public comments on this proposal.
In the CY 2017 Quality Payment Program final rule, we finalized that MIPS eligible clinicians who fail to submit a measure that is required to satisfy the quality performance category submission criteria would receive zero points for that measure (81 FR 77291). We did not propose any changes to the policy to assign zero points for failing to submit a measure that is required in this proposed rule.
We would like to emphasize that MIPS eligible clinicians that fail to submit any measures under the quality performance category will receive a zero score for this category. All MIPS eligible clinicians are required to submit measures under the quality performance category unless there are no measures that are applicable and available or because of extreme and uncontrollable circumstances. For further discussion on extreme and uncontrollable circumstances, see sections II.C.7.b.(3)(c) and III.B of this final rule with comment period.
In the CY 2017 Quality Payment Program final rule, we also finalized implementation of a validation process for claims and registry submissions to validate whether MIPS eligible clinicians have 6 applicable and available measures, whether an outcome measure is available or whether another high priority measure is available if an outcome measure is not available (81 FR 77290 through 77291).
We did not propose any changes to the process for validating whether MIPS eligible clinicians that submit measures via claims and registry submissions have measures available and applicable. We stated in the CY 2017 Quality Payment Program final rule (81 FR 77290) that we did not intend to establish a validation process for QCDRs because we expect that MIPS eligible clinicians that enroll in QCDRs will have sufficient meaningful measures to meet the quality performance category criteria (81 FR 77290 through 77291). We did not propose any changes to this policy.
We also stated that if a MIPS eligible clinician did not have 6 measures relevant within their EHR to meet the full specialty set requirements or meet the requirement to submit 6 measures, the MIPS eligible clinician should select a different submission mechanism to meet the quality performance category requirements and should work with their EHR vendors to incorporate applicable measures as feasible (81 FR 77290 through 77291). Under our proposals discussed in section II.C.6.a.(1) of this final rule with comment period to allow measures to be submitted and scored via multiple mechanisms within a performance category, we anticipated that MIPS eligible clinicians that submit fewer than 6 measures via EHR will have sufficient additional measures available via a combination of submission mechanisms to submit the measures required to meet the quality performance category criteria. For example, the MIPS eligible clinician could submit 2 measures via EHR and supplement that with 4 measures via QCDR or registry.
Therefore, given the proposal to score multiple mechanisms, if a MIPS eligible clinician submits any quality measures via EHR or QCDR, we would not conduct a validation process because we expect these MIPS eligible clinicians to have sufficient measures available to meet the quality performance category requirements. As discussed in section II.C.6.a.(1) of this final rule with comment period, we are not finalizing the proposal to score multiple mechanisms beginning with the CY 2018 performance period as proposed, but instead beginning with the CY 2019 performance period.
Given our proposal to score measures submitted via multiple mechanisms (see 82 FR 30110 through 30113), we proposed to validate the availability and applicability of measures only if a MIPS eligible clinician submits via claims submission options only, registry submission options only, or a combination of claims and registry submission options. In these cases, we proposed that we will apply the validation process to determine if other measures are available and applicable broadly across claims and registry submission options. We will not check if there are measures available via EHR or QCDR submission options for these reporters. We noted that groups cannot report via claims, and therefore groups and virtual groups will only have validation applied across registries. We would validate the availability and applicability of a measure through a clinically related measure analysis based on patient type, procedure, or clinical action associated with the measure specifications. For us to recognize fewer than 6 measures, an individual MIPS eligible clinician must submit exclusively using claims or qualified registries or a combination of the two, and a group or virtual group must submit exclusively using qualified registries. Given the proposal in the proposed rule (82 FR 30110 through 30113) to permit scoring measures submitted via multiple mechanisms, validation will be conducted first by applying the clinically related measure analysis for the individual measure, and then, to the extent technically feasible, validation will be applied to check for available measures available via both claims and registries.
We would like to clarify that we expect that MIPS eligible clinicians would choose a single submission mechanism that would allow them to report 6 measures. Multiple submission mechanisms give MIPS eligible clinicians additional flexibility in reporting the 6 measures, and we do not require using multiple submission mechanisms for reporting quality measures.
The following is a summary of the public comments received on validation only if measures are submitted via claims and/or registry options proposal and our responses:
In the CY 2018 Quality Payment Program proposed rule (82 FR 30109), we recognized that in extremely rare instances there may be a MIPS eligible clinician who may not have available and applicable quality measures. For example, a subspecialist who focuses on a very targeted clinical area may not have any measures available. However, in many cases, the clinician may be part of a broader group or would have the ability to select some of the cross-cutting measures that are available. Given the wide array of submission options, including QCDRs which have the flexibility to develop additional measures, we believe this scenario should be extremely rare. If we are not able to score the quality performance category, we may reweight their score according to the reweighting policies described in section II.C.7.b.(3)(b) and II.C.7.b.(3)(d) of this final rule with comment period. We noted that we anticipate this will be a rare circumstance given our proposals to allow measures to be submitted and scored via multiple mechanisms within a performance category and to allow facility-based measurement for the quality performance category.
In the CY 2017 Quality Payment Program final rule, we finalized that we would award 2 bonus points for each outcome or patient experience measure and 1 bonus point for each additional 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, provided the measure has a performance rate greater than zero, and the measure meets the case minimum and data completeness requirements (81 FR 77293). High priority measures were defined as outcome, appropriate use, patient safety, efficiency, patient experience and care coordination measures. We also finalized that we will apply measure bonus points for the CMS Web Interface for the Quality Payment Program based on the finalized set of measures reportable through that submission mechanism (81 FR 77293). We noted that in addition to the 14 required measures, CMS Web Interface reporters may also report the CAHPS for MIPS survey and receive measure bonus points for submitting that measure. We did not propose any changes to these policies for awarding measure bonus points for reporting high priority measures in the proposed rule.
In the CY 2017 Quality Payment Program final rule, we finalized a cap on high priority measure bonus points at 10 percent of the denominator (total possible measure achievement points the MIPS eligible clinician could receive in the quality performance category) of the quality performance category for the first 2 years of MIPS (81 FR 77294). We did not propose any changes to the cap on measure bonus points for reporting high priority measures, which is codified at § 414.1380(b)(1)(xiv)(D),
Section 1848(q)(5)(B)(ii) of the Act outlines specific scoring rules to encourage the use of CEHRT under the quality performance category. For more of the statutory background and description of the proposed and finalized policies, we referred readers to the CY 2017 Quality Payment Program final rule (81 FR 77294 through 77299).
In the CY 2017 Quality Payment Program final rule at § 414.1380(b)(1)(xiv), we codified that 1 bonus point is available for each quality
We did not propose changes to these policies related to bonus points for using CEHRT for end-to-end reporting in the proposed rule. However, we sought comment on the use of health IT in quality measurement and how HHS can encourage the use of certified EHR technology in quality measurement as established in the statute (82 FR 30109 through 30110).
We thank commenters for their response on the use of health IT in quality measurement and we will consider them in future rulemaking.
In the proposed rule (82 FR 30113 through 30120), we proposed a new methodology to reward improvement based on achievement, from 1 year to another, which requires modifying the calculation of the quality performance category percent score. In the proposed rule (82 FR 30110 through 30113), we summarized the policies for calculating the total measure achievement points and total measure bonus points, prior to scoring improvement and the final quality performance category percent score. We noted that we will refer to policies finalized in the CY 2017 Quality Payment Program final rule that apply to the quality performance category score, which is referred to as the quality performance category percent score in this proposed rule, in this section. We also proposed some refinements to address the ability for MIPS eligible clinicians to submit quality data via multiple submission mechanisms.
In the CY 2017 Quality Payment Program final rule (81 FR 77300), we finalized that 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 did not propose any changes to the policy to score the measures with the highest number of assigned points in this proposed rule; however, we proposed refinements to account for measures being submitted across multiple submission mechanisms.
In the CY 2017 Quality Payment Program final rule, we sought comment on whether to score measures submitted across multiple submission mechanisms (81 FR 77275) and on what approach we should use to combine the scores for quality measures from multiple submission mechanisms into a single aggregate score for the quality performance category (81 FR 77275). We summarized the comments that were received in the proposed rule (82 FR 30110).
We proposed, beginning with the 2018 MIPS performance period, a method to score quality measures if a MIPS eligible clinician submits measures via more than one of the following submission mechanisms: Claims, qualified registry, EHR or QCDR submission options. We noted that we believe that allowing MIPS eligible clinicians to be scored across these data submission mechanisms in the quality performance category will provide additional options for MIPS eligible clinicians to report the measures required to meet the quality performance category criteria, and encourage MIPS eligible clinicians to begin using electronic submission mechanisms, even if they may not have 6 measures to report via a single electronic submission mechanism alone. We noted that we also continue to score the CMS-approved survey vendor for CAHPS for MIPS submission options in conjunction with other submission mechanisms (81 FR 77275) as noted in Table 21.
We proposed to score measures across multiple mechanisms using the following rules:
• As with the rest of MIPS, we will only score measures within a single identifier. For example, as codified in § 414.1310(e), eligible clinicians and MIPS eligible clinicians within a group aggregate their performance data across the TIN in order for their performance to be assessed as a group. Therefore, measures can only be scored across multiple mechanisms if reported by the same individual MIPS eligible clinician, group, virtual group or APM Entity, as described in Table 21.
• We did not propose to aggregate measure results across different submitters to create a single score for an individual measure (for example, we are not going to aggregate scores from different TINs within a virtual group TIN to create a single virtual group score for the measures; rather, virtual groups must perform that aggregation across TINs prior to data submission to CMS). Virtual groups are treated like other groups and must report all of their measures at the virtual group level, for the measures to be scored. Data completeness and all the other criteria will be evaluated at the virtual group level. Then the same rules apply for selecting which measures are used for scoring. In other words, if a virtual group representative submits some measures via a qualified registry and other measures via EHR, but an individual TIN within the virtual group also submits measures, we will only use the scores from the measures that were submitted at the virtual group level, because the TIN submission does not use the virtual group identifier. This is consistent with our other scoring principles, where, for virtual groups, all quality measures are scored at the virtual group level.
• Separately, as also described in Table 21, because CMS Web Interface and facility-based measurement each have a comprehensive set of measures that meet the proposed MIPS submission requirements, we did not propose to combine CMS Web Interface measures or facility-based measurement with other group submission mechanisms (other than CAHPS for MIPS, which can be submitted in conjunction with the CMS Web Interface). We refer readers to section II.C.7.a.(2)(h)(ii) of this final rule with comment period for discussion of calculating the total measure achievement and measure bonus points for CMS Web Interface reporters. We refer readers to section II.C.7.a.(4) of the final rule with comment period for a description of our policies on facility-based measurement. We list these submission mechanisms in Table 21, to illustrate that CMS Web Interface submissions and facility-based measurement cannot be combined with other submission options, except that the CAHPS for MIPS survey can be combined with CMS Web Interface, as described in the proposed rule (82 FR 30113).
• If a MIPS eligible clinician submits the same measure via 2 different submission mechanisms, we will score each mechanism by which the measure is submitted for achievement and take the highest measure achievement points of the 2 mechanisms.
• Measure bonus points for high priority measures would be added for all measures submitted via all the different submission mechanisms available, even if more than 6 measures are submitted, but high priority measure bonus points are only available once for each unique measure (as noted by the measure number) that meets the criteria for earning the bonus point. For example, if a MIPS eligible clinician submits 8 measures—6 process and 2 outcome—and both outcome measures meet the criteria for a high priority bonus (meeting the required data completeness, case minimum, and has a performance rate greater than zero), the outcome measure with the highest measure achievement points would be scored as the required outcome measure and then the measures with the next 5 highest measure achievement points will contribute to the final quality score. This could include the second outcome measure but does not have to. Even if the measure achievement points for the second outcome measure are not part of the quality performance category percent score, measure bonus points would still be available for submitting a second outcome measure and meeting the requirement for the high priority measure bonus points. The rationale for providing measure bonus points for measures that do not contribute measure achievement points to the quality performance category percent score is that it would help create better benchmarks for outcome and other high priority measures by encouraging clinicians to report them even if they may not have high performance on the measure. We also want to encourage MIPS eligible clinicians to submit to us all of their available MIPS data, not only the data that they or their intermediary deem to be their best data. We believe it will be in the best interest of all MIPS eligible clinicians that we determine which measures will result in the clinician receiving the highest MIPS score. If the same measure is submitted through multiple submission mechanisms, we would apply the bonus points only once to the measure. We proposed to amend § 414.1380(b)(1)(xiv) (as redesignated from § 414.1380(b)(1)(xiii)) to add paragraph (b)(1)(xiv)(E) that if the same high priority measure is submitted via two or more submission mechanisms, as determined using the measure ID, the measure will receive high priority measure bonus points only once for the measure. The total measure bonus points for high-priority measures would still be capped at 10 percent of the total possible measure achievement points.
• Measure bonus points that are available for the use of end-to-end electronic reporting would be calculated for all submitted measures across all submission mechanisms, including measures that cannot be reliably scored against a benchmark. If the same measure is submitted through multiple submission mechanisms, then we would apply the bonus points only once to the measure. For example, if the same measure is submitted using end-to-end reporting via both a QCDR and EHR reporting mechanism, the measure would only get a measure bonus point one time. We proposed to amend § 414.1380(b)(1)(xv) (as redesignated) to add that if the same measure is submitted via two or more submission mechanisms, as determined using the measure ID, the measure will receive measure bonus points only once for the measure. The total measure bonus points for end-to-end electronic reporting would still be capped at 10 percent of the total available measure achievement points.
Although we provided a policy to account for scoring in those circumstances when the same measure is submitted via multiple mechanisms, we anticipated that this will be a rare circumstance and do not encourage clinicians to submit the same measure via multiple mechanisms. Table 22 illustrates how we would assign total measure achievement points and total measure bonus points across multiple submission mechanisms under the proposal. In this example, a MIPS eligible clinician elects to submit quality data via 3 submission mechanisms: 3 measures via registry, 4 measures via claims, and 5 measures via EHR. The 3 registry measures are also submitted via claims (as noted by the same measure letter in this example). The EHR measures do not overlap with either the registry or claims measures. In this example, we assign measure achievement and bonus points for each measure. If the same measure (as determined by measure ID) is submitted, then we use the highest achievement points for that measure. For the bonus points, we assess which of the outcome measures meets the outcome measure requirement and then we identify any other unique measures that qualify for the high priority bonus. We also identify the unique measures that qualify for end-to-end electronic reporting bonus.
We proposed to amend § 414.1380(b)(1)(xii) to add paragraph (A) to state that if a MIPS eligible clinician submits measures via claims, qualified registry, EHR, or QCDR submission options, and submits more than the required number of measures, they are scored on the required measures with the highest assigned measure achievement points. MIPS eligible clinicians that report a measure via more than 1 submission mechanism can be scored on only 1 submission mechanism, which will be the submission mechanism with the highest measure achievement points. Groups that submit via these submission mechanisms may also submit and be scored on CMS-approved survey vendor for CAHPS for MIPS submission mechanisms.
We invited comments on the proposal to calculate the total measure achievement points by using the measures with the 6 highest measure achievement points across multiple submission mechanisms. We invited comments on the proposal that if the same measure is submitted via 2 or more mechanisms, we will only take the one with the highest measure achievement points. We invited comments on the proposal to assign high priority measure bonus points to all measures, with performance greater than zero, that meet case minimums, and that meet data completeness requirements, regardless of submission mechanism and to assign measure bonus points for each unique measure submitted using end-to-end electronic reporting. We invited comments on the proposal that if the same measure is submitted using 2 different mechanisms, the measure will receive measure bonus points once.
We did not propose any changes to our policy that if a MIPS eligible clinician does not have any scored measures, then a quality performance category percent score will not be calculated as finalized in the CY 2017 Quality Payment Program final rule at 81 FR 77300. We referred readers to the discussion at 81 FR 77299 through 77300 for more details on that policy. We noted in the proposed rule (82 FR 30108 through 30109) that we anticipate that it will be only in rare case that a MIPS eligible clinician does not have any scored measures and a quality performance category percent score cannot be calculated.
The following is a summary of the public comments received on
In the CY 2017 Quality Payment Program final rule, we finalized that CMS Web Interface reporters are required to report 14 measures, 13 individual measures, and a 2-component measure for diabetes (81 FR 77302 through 77305). We noted that for
In the CY 2017 Quality Payment Program final rule, we finalized a global floor of 3 points for all CMS Web Interface measures submitted in the transition year, even with measures at zero percent performance rate, provided that these measures have met the data completeness criteria, have a benchmark and meet the case minimum requirements (82 FR 77305). Therefore, 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 for other measures and because the Shared Savings Program does not publish benchmarks below the 30th percentile (82 FR 77305). We stated that we will reassess scoring for measures below the 30th percentile in future years.
We proposed to continue to assign 3 points for measures with performance below the 30th percentile, provided the measure meets data completeness, has a benchmark, and meets the case minimum requirements for the 2018 MIPS performance year; we made this proposal in order to continue to align with the 3-point floor for other measures and because the Shared Savings Program does not publish benchmarks with values below the 30th percentile (82 FR 30113). We will reassess this policy again next year through rulemaking.
We did not propose any changes to our previously finalized policy to exclude from scoring CMS Web Interface measures that are submitted but that do not meet the case minimum requirement or that lack a benchmark, or to our policy that measures that are not submitted and measures submitted below the data completeness requirements will receive a zero score (82 FR 77305). However, to further increase alignment with the Shared Savings Program, we proposed to also exclude CMS Web Interface measures from scoring if the measure is redesignated from pay for performance to pay for reporting for all Shared Savings Program ACOs, although we will recognize the measure was submitted. While the Shared Savings Program designates measures that are pay for performance in advance of the reporting year, the Shared Savings Program may redesignate a measure as pay for reporting under certain circumstances (see 42 CFR 425.502(a)(5)). Therefore, we proposed to amend § 414.1380(b)(1)(viii) to add that CMS Web Interface measures that have a measure benchmark but are redesignated as pay for reporting for all Shared Savings Program ACOs by the Shared Savings Program will not be scored, as long as the data completeness requirement is met.
We invited comment on our proposal to not score CMS Web Interface measures redesignated as pay for reporting by the Shared Savings Program.
We also noted that, while we did not state explicitly in the CY 2017 Quality Payment Program final rule, groups that choose to report quality measures via the CMS Web Interface may, in addition to the 14 required measures, also submit the CAHPS for MIPS survey in the quality performance category (81 FR 77094 through 77095; 81 FR 77292). If they do so, they can receive bonus points for submitting this high priority measure and will be scored on it as an additional measure. Therefore, we proposed to amend § 414.1380(b)(1)(xii) to add paragraph (B) to state that groups that submit measures via the CMS Web Interface may also submit and be scored on CMS-approved survey vendor for CAHPS for MIPS submission options.
In addition, groups of 16 or more eligible clinicians that meet the case minimum for administrative claims measures will automatically be scored on the all-cause hospital readmission measure and have that measure score included in their quality category performance percent score.
We did not propose any changes to calculating the total measure achievement points and measure bonus points for CMS Web Interface measures in the proposed rule, although we proposed to add improvement to the quality performance category percent score for such submissions (as well as other submission mechanisms) in the proposed rule (82 FR 30119 through FR 30120).
The following is a summary of the public comments received on the scoring for CMS Web Interface proposal and our responses:
In the CY 2017 Quality Payment Program final rule, we noted that 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 the performance category (81 FR 77274). We also solicited public comments in the CY 2017 Quality Payment Program proposed rule on potential ways to incorporate improvement in the scoring methodology. In the CY 2018 Quality Payment Program proposed rule (82 FR 30096 through 30098), we explained why we believe that the options set forth in the CY 2017 Quality Payment Program proposed rule, including the Hospital VBP Program, the Shared Savings Program, and Medicare Advantage 5-star Ratings Program, were not fully translatable to MIPS. Beginning with the 2018 MIPS performance period, we proposed to score improvement, as well as achievement in the quality performance category level when data is sufficient (82 FR 30113 through 30114). We believe that scoring improvement at the performance category level, rather than measuring improvement at the measure level, for the quality performance category would allow improvement to be available to the broadest number of MIPS eligible clinicians because we are connecting performance to previous MIPS quality performance as a whole rather than changes in performance for individual measures. Just as we believe it is important for a MIPS eligible clinician to have the flexibility to choose measures that are meaningful to their practice, we want them to be able to adopt new measures without concern about losing the ability to be measured
We proposed at § 414.1380(b)(1)(xvi)(E) to define an improvement percent score to mean the score that represents improvement for the purposes of calculating the quality performance category percent score. We also proposed at § 414.1380(b)(1)(xvi)(C) that an improvement percent score would be assessed at the quality performance category level and included in the calculation of the quality performance category percent score. When we evaluated different improvement scoring options, we saw two general methods for incorporating improvement. One method measures both achievement and improvement and takes the higher of the two scores for each measure that is compared. The Hospital VBP Program incorporates such a methodology. The second method is to calculate an achievement score and then add an improvement score if improvement is measured. The Shared Savings Program utilizes a similar methodology for measuring improvement. For the quality performance category, we proposed to calculate improvement at the category level and believe adding improvement to an existing achievement percent score would be the most straight-forward and simple way to incorporate improvement. For the purpose of improvement scoring methodology, the term “quality performance category achievement percent score” means the total measure achievement points divided by the total possible available measure achievement points, without consideration of bonus points or improvement adjustments and is discussed in the proposed rule (82 FR 30116 through 30117).
Consistent with bonuses available in the quality performance category, we proposed at § 414.1380(b)(1)(xvi)(B) that the improvement percent score may not total more than 10 percentage points.
We invited public comments on these proposals.
The following is a summary of the public comments received on the proposal for scoring improvement at the quality performance category level and our responses:
We do not believe our improvement scoring methodology will drive clinicians to select different measures in order to earn a higher improvement score, nor do we anticipate that clinicians will make investments to change and excel at quality measures solely to earn a higher improvement score. As noted in section II.C.7.a.(1)(b)(i) of this final rule with comment period, we intend to evaluate the implementation of improvement scoring for the quality and cost performance categories to determine how the policies we establish in this final rule with comment period are affecting MIPS eligible clinicians.
Section 1848(q)(5)(D)(i) of the Act stipulates that beginning with the second year to which the MIPS applies, if data sufficient to measure improvement is available, then we shall measure improvement for the quality performance category. Measuring improvement requires a direct comparison of data from one Quality Payment Program year to another. Starting with the 2020 MIPS payment year, we proposed that a MIPS eligible clinician's data would be sufficient to score improvement in the quality performance category if the MIPS eligible clinician had a comparable quality performance category achievement percent score for the MIPS performance period immediately prior to the current MIPS performance period (82 FR 30114); we explain our proposal to identify how we will identify “comparable” quality performance category achievement percent scores below. We noted that we believe that this approach would allow improvement to be broadly available to MIPS eligible clinicians and encourage continued participation in the MIPS program. Moreover, this approach would encourage MIPS eligible clinicians to focus on efforts to improve the quality of care delivered. We noted that, by measuring improvement based only on the overall quality performance category achievement percent score, some MIPS eligible clinicians and groups may generate an improvement score simply by switching to measures on which they perform more highly, rather than actually improving at the same measures. We will monitor how frequently improvement is due to actual improvement versus potentially perceived improvement by switching measures and will address through future rulemaking, as needed. We also solicited comment on whether we should require some level of year to year consistency when scoring improvement.
We proposed that “comparability” of quality performance category achievement percent scores would be established by looking first at the submitter of the data. As discussed in more detail in the proposed rule (82 FR 300113 through 300114), we are comparing results at the category, rather than the performance measure level because we believe that the performance category score from 1 year is comparable to the performance category score from the prior performance period, even if the measures in the performance category have changed from year to year.
We proposed to compare results from an identifier when we receive submissions with that same identifier (either TIN/NPI for individual, or TIN for group, APM entity, or virtual group identifier) for two consecutive performance periods. However, if we do
There are times when submissions from a particular individual clinician or group of clinicians use different identifiers between 2 years. For example, a group of 20 MIPS eligible clinicians could choose to submit as a group (using their TIN identifier) for the current performance period. If the group also submitted as a group for the previous year's performance period, we would simply compare the group scores associated with the previous performance period to the current performance period (following the methodology explained in the proposed rule (82 FR 30116 through 30117)). However, if the group members had previously elected to submit to MIPS as individual clinicians, we would not have a group score at the TIN level from the previous performance period to which to compare the current performance period.
In circumstances where we do not have the same identifier for 2 consecutive performance periods, we proposed to identify a comparable score for individual submissions or calculate a comparable score for group, virtual group, and APM entity submissions. For individual submissions, if we do not have a quality performance category achievement percent score for the same individual identifier in the immediately prior period, then we proposed to apply the hierarchy logic that is described in section II.C.8.a.(2) of the proposed rule (82 FR 30146 through 30147) to identify the quality performance category achievement score associated with the final score that would be applied to the TIN/NPI for payment purposes. For example, if there is no historical score for the TIN/NPI, but there is a TIN score (because in the previous period the TIN submitted as a group), then we would use the quality performance category achievement percent score associated with the TIN's prior performance. If the NPI had changed TINs and there was no historical score for the same TIN/NPI, then we would take the highest prior score associated with the NPI.
When we do not have a comparable TIN group, virtual group, or APM Entity score, we proposed to calculate a score based on the individual TIN/NPIs in the practice for the current performance period. For example, in a group of 20 clinicians that previously participated in MIPS as individuals, but now want to participate as a group, we would not have a comparable TIN score to use for scoring improvement. We believe however it is still important to provide to the MIPS eligible clinicians the improvement points they have earned. Similarly, in cases where a group of clinicians previously participated in MIPS as individuals, but now participates as a new TIN, or a new virtual group, or a new APM Entity submitting data in the performance period, we would not have a comparable TIN, virtual group, or APM Entity score to use for scoring improvement. Therefore, we proposed to calculate a score by taking the average of the individual quality performance category achievement scores for the MIPS eligible clinicians that were in the group for the current performance period. If we have more than one quality performance category achievement percent score for the same individual identifier in the immediately prior period, then we proposed to apply the hierarchy logic that is described in section II.C.8.a.(2) of the proposed rule (82 FR 30146 through 30147) to identify the quality performance category score associated with the final score that would be applied to the TIN/NPI for payment purposes. We would exclude any TIN/NPIs that did not have a final score because they were not eligible for MIPS. We would include quality performance category achievement percent scores of zero in the average.
There are instances where we would not be able to measure improvement due to lack of sufficient data. For example, if the MIPS eligible clinicians did not participate in MIPS in the previous performance period because they were not eligible for MIPS, we could not calculate improvement because we would not have a previous quality performance category achievement percent score.
Table 26 in the proposed rule (82 FR 30115) summarized the different cases when a group or individual would be eligible for improvement scoring under the proposal which we have replicated for convenience in Table 23.
We proposed at § 414.1380(b)(1)(xvi)(A) to state that improvement scoring is available when the data sufficiency standard is met, which means when data are available and a MIPS eligible clinician or group has a quality performance category achievement percent score for the previous performance period. We also proposed at § 414.1380(b)(1)(xvi)(A)(1) that data must be comparable to meet the requirement of data sufficiency, which means that the quality performance category achievement percent score is available for the current performance period and the previous performance period and, therefore, quality performance category achievement percent scores can be compared. We also proposed at § 414.1380(b)(1)(xvi)(A)(2) that quality performance category achievement percent scores are comparable when submissions are received from the same identifier for two consecutive performance periods. We also proposed an exception at § 414.1380(b)(1)(xvi)(A)(3) that if the identifier is not the same for 2 consecutive performance periods, then for individual submissions, the comparable quality performance category achievement percent score is the quality performance category achievement percent score associated with the final score from the prior performance period that will be used for payment. For group, virtual group, and APM entity submissions, the comparable quality performance category achievement percent score is the average of the quality performance category achievement percent score associated with the final score from the prior performance period that will be used for payment for each of the individuals in the group. As noted above, the proposals were designed to offer improvement scoring to all MIPS eligible clinicians with sufficient data in the prior MIPS performance period. We invited public comments on our proposals as they relate to data sufficiency for improvement scoring.
We also sought comment on an alternative to the proposal: whether we should restrict improvement to those who submit quality performance data using the same identifier for two consecutive MIPS performance periods. We believed this option would be simpler to apply, communicate and understand than our proposal is, but this alternative could have the unintended consequence of not allowing improvement scoring for certain MIPS eligible clinicians, groups, virtual groups and APM entities.
The following is a summary of the public comments received on our proposals related to data sufficiency for improvement scoring and our responses:
To receive a quality performance category improvement percent score greater than zero, we also proposed that MIPS eligible clinicians must fully participate, which we proposed in § 414.1380(b)(1)(xvi)(F) to mean compliance with § 414.1330 and § 414.1340, in the current performance year (81 FR 30116). Compliance with those referenced regulations entails the submission of all required measures, including meeting data completeness, for the quality performance category for the current performance period. For example, for MIPS eligible clinicians submitting via QCDR, full participation would generally mean submitting 6 measures including 1 outcome measure if an outcome measure is available or 1 high priority measure if an outcome measure is not available, and meeting the 60 percent data completeness criteria for each of the 6 measures.
We believe that improvement is most meaningful and valid when we have a full set of quality measures. A comparison of data resulting from full participation of a MIPS eligible clinician from 1 year to another enables a more accurate assessment of improvement because the performance being compared is based on the applicable and available measures for the performance periods and not from changes in participation. While we did not require full participation for both performance periods, requiring full participation for the current performance period means that any future improvement scores for a clinician or group would be derived solely from changes in performance and not because the clinician or group submitted more measures. We proposed at § 414.1380(b)(1)(xvi)(C)(5) that the quality improvement percent score is zero if the clinician did not fully participate in the quality performance category for the current performance period.
Because we want to award improvement for net increases in performance and not just improved participation in MIPS, we want to measure improvement above a floor for the 2018 MIPS performance period, to account for our transition year policies. We considered that MIPS eligible clinicians who chose the “test” option of the “pick your pace” approach for the transition year may not have submitted all the required measures and, as a result, may have a relatively low quality performance category achievement score for the 2017 MIPS performance period. Due to the transition year policy to award at least 3 measure achievement points for any submitted measure via claims, EHR, QCDR, qualified registry, and CMS-approved survey vendor for CAHPS for MIPS, and the 3-point floor for the all-cause readmission measure (if the measure applies), a MIPS eligible clinician that submitted some data via these mechanisms on the required number of measures would automatically have a quality performance category achievement score of at least 30 percent because they would receive at least 3 of 10 possible measure achievement points for each required measure. For example, if a solo practitioner submitted 6 measures and received 3 points for each measure, then the solo practitioner would have 18 measure achievement points out of a possible 60 total possible measure achievement points (3 measure achievement points × 6 measures). The
Therefore, we proposed at § 414.1380(b)(1)(xvi)(C)(4) that if a MIPS eligible clinician has a previous year quality performance category score less than or equal to 30 percent, we would compare 2018 performance to an assumed 2017 quality performance category achievement percent score of 30 percent. In effect, for the MIPS 2018 performance period, improvement would be measured only if the clinician's 2018 quality performance category achievement percent score for the quality performance category exceeds 30 percent. We believe this approach appropriately recognizes the participation of MIPS eligible clinicians who participated in the transition year and accounts for MIPS eligible clinicians who participated minimally and may otherwise be awarded for an increase in participation rather than an increase in achievement performance.
We invited public comment on these proposals.
The following is a summary of the public comments received on our proposal for full participation related to improvement scoring and our responses:
To calculate improvement with a focus on quality performance, we proposed to focus on improvement based on achievement performance and would not consider measure bonus points in our improvement algorithm (82 FR 30116 through 30117). Bonus points may be awarded for reasons not directly related to performance such as the use of end-to-end electronic reporting. We believe that improvement points should be awarded based on improvement related to achievement. Accordingly, we are proposing to use an individual MIPS eligible clinician's or group's total measure achievement points from the prior MIPS performance period without the bonus points the individual MIPS eligible clinician or group may have received, to calculate improvement. Therefore, to measure improvement at the quality performance category level, we will use the quality performance category achievement percent score excluding measure bonus points (and any improvement score) for the applicable years. We proposed at § 414.1380(b)(1)(xvi)(D) to call this score, which is based on achievement only, the “quality performance category achievement percent score” which is calculated using the following formula:
The current MIPS performance period quality performance category achievement percent score is compared to the previous performance period quality performance category achievement percent score. If the current score is higher, the MIPS eligible clinician may qualify for an improvement percent score to be added into the quality performance category percent score for the current performance year. Table 27 of the proposed rule (82 FR 30117) illustrated how the quality performance category achievement percent score is calculated.
We proposed to amend the regulatory text at § 414.1380(b)(1)(xvi) to state that improvement scoring is available to MIPS eligible clinicians and groups that demonstrate improvement in performance in the current MIPS performance period compared to the performance in the previous MIPS performance period, based on achievement. Bonus points or improvement percent score adjustments made to the category score in the prior or current performance period are not taken into account when determining whether an improvement has occurred or the size of any improvement percent score.
We invited public comment on our proposal to award improvement based on changes in the quality performance category achievement percent score.
The following is a summary of the public comments received on our proposal to measure improvement based on changes in achievement in the quality performance category and our responses:
We are also finalizing as proposed to call the score at § 414.1380(b)(1)(xvi)(D), which is based on achievement only, the “quality performance category achievement percent score,” which is calculated using the formula as proposed.
We noted that we believe the improvement scoring methodology that we are proposing for the quality performance category recognizes the rate of increase in quality performance category scores of MIPS eligible clinicians from one performance period to another performance period so that a higher rate of improvement results in a higher improvement percent score. We believe this is particularly true for those clinicians with lower performance who will be incentivized to begin improving with the opportunity to increase their improvement significantly and achieve a higher improvement percent score.
We proposed to award an “improvement percent score” based on the following formula:
In the proposed rule (82 FR 30117), we provided an example of how to score the improvement percent score. We noted that we believe that this improvement scoring methodology provides an easily explained and applied approach that is consistent for all MIPS eligible clinicians. Additionally, it provides additional incentives for MIPS eligible clinicians who are lower performers to improve performance. We believe that providing larger incentives for MIPS eligible clinicians with lower quality performance category scores to improve will not only increase the quality performance category scores but also will have the greatest impact on improving quality for beneficiaries.
We also proposed that the improvement percent score cannot be negative (that is, lower than zero percentage points). The improvement percent score would be zero for those who do not have sufficient data or who are not eligible under our proposal for improvement points. For example, a MIPS eligible clinician would not be eligible for improvement if the clinician was not eligible for MIPS in the prior performance period and did not have a quality performance category achievement percent score. We also proposed to cap the size of the improvement award at 10 percentage points, which we believe appropriately rewards improvement and does not outweigh percentage points available through achievement. In effect, 10 percentage points under our proposed formula would represent 100 percent improvement—or doubling of achievement measure points—over the immediately preceding period. For the
Table 28 of the proposed rule (82 FR 30118), and included in Table 24, illustrated examples of the proposed improvement percent scoring methodology, which is based on rate of increase in quality performance category achievement percent scores. We also considered an alternative to measuring the rate of improvement. The alternative would use band levels to determine the improvement points for MIPS eligible clinicians who qualify for improvement points. Under the band level methodology, a MIPS eligible clinician's improvement points would be determined by an improvement in the quality performance category achievement percent score from 1 year to the next year to determine improvement in the same manner as set forth in the rate of improvement methodology. However, for the band level methodology, an improvement percent score would then be assigned by taking into account a portion (50, 75 or 100 percent) of the improvement in achievement, based on the clinician's performance category achievement percent score for the prior performance period. Bands would be set for category achievement percent scores, with increases from lower category achievement scores earning a larger portion (percentage) of the improvement points. Under this alternative, simple improvement percentage points for improvement are awarded to MIPS eligible clinicians whose category scores improved across years according to the band level, up to a maximum of 10 percent of the total score. In Table 29 of the proposed rule (82 FR 30118), we illustrated the band levels we considered as part of this alternative proposal. Table 30 of the proposed rule (82 FR 30119) illustrated examples of the improvement scoring methodology based on band levels. Generally, this methodology would generate a higher improvement percent score for clinicians; however, we noted that we believe the policy we proposed would provide a score that better represents true improvement at the performance category level, rather than comparing simple increases in performance category scores.
In addition, we considered another alternative that would adopt the improvement scoring methodology of the Shared Savings Program
We considered the Shared Savings Program methodology because it would promote alignment with ACOs. We ultimately decided not to adopt this scoring methodology because we believe having a single performance category level approach for all quality performance category scores encourages a uniformity in our approach to improvement scoring and simplifies the scoring rules for MIPS eligible clinicians. It also allows us greater flexibility to compare performance scores across the diverse submission mechanisms, which makes improvement scoring more broadly available to eligible clinicians and groups that elect different ways of participating in MIPS.
We proposed to add regulatory text at § 414.1380(b)(1)(xvi)(C)(3) to state that an improvement percent score cannot be negative (that is, lower than zero percentage points). We also proposed to add regulatory text at § 414.1380(b)(1)(xvi)(C)(1) to state that improvement scoring is awarded based on the rate of increase in the quality performance category achievement percent score of individual MIPS eligible clinicians or groups from the current MIPS performance period compared to the score in the year immediately prior to the current MIPS
We invited public comments on our proposal to calculate improvement scoring using a methodology that awards improvement points based on the rate of improvement and, alternatively, on rewarding improvement at the band level or using the Shared Savings Program approach for CMS Web Interface submissions.
The following is a summary of the public comments received on our proposal for the methodology to calculate improvement of the quality performance category and our response:
In the CY 2017 Quality Payment Program final rule, we finalized at § 414.1380(b)(1)(xv) that the quality performance category score is the sum of all points assigned for the measures required for the quality performance category criteria plus bonus points, divided by the sum of total possible points (81 FR 77300). Using the terminology proposed in section II.C.7.a.(2) of the proposed rule (82 FR 30098 through 30099), this formula can be represented as:
We proposed to incorporate the improvement percent score, which was proposed in section II.C.7.a.(2)(i)(i) of the proposed rule (82 FR 30113 through 30114), into the quality performance category percent score. We proposed to amend § 414.1380(b)(1)(xv) (redesignated as § 414.1380(b)(1)(xvii)) to add the improvement percent score (as calculated pursuant to proposed paragraph (b)(1)(xvi)(A) through (F)) to the quality performance score. We also proposed to amend § 414.1380(b)(1)(xv) (redesignated as § 414.1380(b)(1)(xvii)) to amend the text that states the quality performance category percent score cannot exceed the total possible points for the quality performance category to clarify that the total possible points for the quality performance category cannot exceed 100 percentage points. Thus, the calculation for the proposed quality performance category percent score including improvement, can be summarized in the following formula:
This same formula and logic will be applied for both CMS Web Interface and Non-CMS Web Interface reporters.
Table 31 of the proposed rule (82 FR 30120) illustrated an example of calculating the quality performance category percent score including improvement for a non-CMS Web Interface reporter. We noted that the quality performance category percent score is then multiplied by the performance category weight for calculating the points towards the final score.
We invited public comment on this overall methodology and formula for calculating the quality performance category percent score.
The following is a summary of the public comments received on the “Calculating the Quality Performance Category Percent Score Including Improvement” proposals and our responses:
We score the cost performance category using a methodology that is generally consistent with the methodology used for the quality performance category. In the CY 2017 Quality Payment Program final rule (81 FR 77309), we codified at § 414.1380(b)(2) that a MIPS eligible clinician receives 1 to 10 achievement points for each cost measure attributed to the MIPS eligible clinician based on the MIPS eligible clinician's performance compared to the measure benchmark. We establish a single benchmark for each cost measure and base those benchmarks on the performance period (81 FR 77309). Because we base the benchmarks on the performance period, we will not be able to publish the actual numerical benchmarks in advance of the performance period (81 FR 77309). We develop a benchmark for a cost 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 (81 FR 77309). If a benchmark is not developed, the cost measure is not scored or included in the performance category (81 FR 77309). For each set of benchmarks, we calculate the decile breaks based on cost measure performance during the performance period and 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 (81 FR 77309 through 77310). We also codified at § 414.1380(b)(2)(iii) that a MIPS eligible clinician's cost performance category score is the equally-weighted average of all scored cost measures (81 FR 77311).
In the CY 2017 Quality Payment Program final rule (81 FR 77311), we adopted a final policy to not calculate a cost performance category score if a MIPS eligible clinician or group is not attributed any cost measures because the MIPS eligible 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. We inadvertently failed to include this policy in the regulation text and proposed to codify it under § 414.1380(b)(2)(v) (82 FR 30120).
For more of the statutory background and descriptions of our current policies for the cost performance category, we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77308 through 77311).
In the CY 2018 Quality Payment Program proposed rule (82 FR 30098), we proposed to add improvement scoring to the cost performance category scoring methodology starting with the 2020 MIPS payment year. We did not propose any changes to the methodology for scoring achievement in the cost performance category for the 2020 MIPS payment year other than the method used for facility-based measurement described in the CY 2018 Quality Payment Program proposed rule (82 FR 30128 through 30132). We proposed a change in terminology to refer to the “cost performance category percent score” in order to be consistent with the terminology used in the quality performance category (82 FR 30120). We proposed to revise § 414.1380(b)(2)(iii) to provide that a MIPS eligible clinician's cost performance category percent score is the sum of the following, not to exceed 100 percent: The total number of achievement points earned by the MIPS eligible clinician divided by the total number of available achievement points (which can be expressed as a percentage); and the cost improvement score (82 FR 30121). This terminology change to refer to the score as a percentage is consistent with the proposed change in the CY 2018 Quality Payment Program proposed rule (82 FR 30099) for the quality performance category. We discussed the proposals for improvement scoring in the cost performance category in of the CY 2018 Quality Payment Program proposed rule (82 FR 30121).
The following is a summary of the public comments received on these proposals and our responses:
In the CY 2018 Quality Payment Program proposed rule (82 FR XXX), we proposed to make available to MIPS eligible clinicians and groups a method of measuring improvement in the quality and cost performance categories. In the CY 2018 Quality Payment Program proposed rule (82 FR 30113 through 30114), for the quality performance category, we proposed to assess improvement on the basis of the score at the performance category level. For the cost performance category, similar to the quality performance category, we proposed at § 414.1380(b)(2)(iv) that improvement scoring is available to MIPS eligible clinicians and groups that demonstrate improvement in performance in the current MIPS performance period compared to their performance in the immediately preceding MIPS performance period (for example, demonstrating improvement in the 2018 MIPS performance period over the 2017 MIPS performance period).
In the CY 2018 Quality Payment Program proposed rule (82 FR 30113 through 30114), we noted the various challenges associated with attempting to measure improvement in the quality performance category at the measure level, given the many opportunities available to clinicians to select which measures to report. We noted that these challenges are not present in the cost performance category and explained our reasons for believing that there are advantages to measuring cost improvement at the measure level. Therefore, we proposed at section § 414.1380(b)(2)(iv)(A) to measure cost improvement at the measure level for the cost performance category.
In the CY 2018 Quality Payment Program proposed rule, we described our reasons for believing that we would have data sufficient to measure improvement when we can measure performance in the current performance period compared to the prior performance period. Due to the differences in our proposals for measuring improvement for the quality and cost performance categories, such as measuring improvement at the measure level versus the performance category level, we proposed a different data sufficiency standard for the cost performance category than for the quality performance category. First, for data sufficient to measure improvement to be available for the cost performance category, we proposed that the same cost measure(s) would need to be specified for the cost performance category for 2 consecutive performance periods (82 FR 30121). For the 2020 MIPS payment year, only 2 cost measures, the MSPB measure and the total per capita cost measure, would be eligible for improvement scoring under this proposal. For a measure to be scored in either performance period, a MIPS eligible clinician would need to have a sufficient number of attributed cases to meet or exceed the case minimum for the measure.
In addition, we proposed that a clinician would have to report for MIPS using the same identifier (TIN/NPI combination for individuals, TIN for groups, or virtual group identifiers for virtual groups) and be scored on the same measure(s) for 2 consecutive performance periods (82 FR 30121). Because we wanted to encourage action on the part of clinicians in reviewing and understanding their contribution to patient costs, we believed that improvement should be evaluated only when there is a consistent identifier.
Therefore, for the cost performance category, we proposed at § 414.1380(b)(2)(iv)(B) that we would calculate a cost improvement score only when data sufficient to measure improvement is available (82 FR 30121). We proposed that sufficient data would be available when a MIPS eligible clinician participates in MIPS using the same identifier in 2 consecutive performance periods and is scored on the same cost measure(s) for 2 consecutive performance periods (for example, in the 2017 MIPS performance period and the 2018 MIPS performance period) (82 FR 30121). If the cost improvement score cannot be calculated because sufficient data is not available, we proposed to assign a cost improvement score of zero percentage points (82 FR 30121). While the total available cost improvement score would be limited at first because only 2 cost measures would be included in both the first and second performance periods of the program (total per capita cost and MSPB), more opportunities for improvement scoring would be available in the future as additional cost measures, including episode-based measures, are added in future rulemaking. MIPS eligible clinicians would be able to review their performance feedback and make improvements compared to the score in their previous feedback.
The following is a summary of the public comments received on these proposals and our responses:
In the CY 2018 Quality Payment Program proposed rule (82 FR 30096 through 30097), we discussed a number of different programs and how they measure improvement at the category or measure level as part of their scoring systems. In the proposed method for the quality performance category, we proposed to compare the overall rate of achievement on all the underlying measures in the quality performance category and measure a rate of overall improvement to calculate an improvement percent score. We then add the improvement percent score after taking into account measure achievement points and measure bonus points as described in proposed § 414.1380(b)(1)(xvii). In reviewing the methodologies that are specified in the CY 2018 Quality Payment Program proposed rule that include consideration of improvement at the measure level, we noted that the methodology used in the Shared Savings Program would best reward achievement and improvement for the cost performance category because this program includes measures for clinicians, the methodology is straightforward, and it only recognizes significant improvement (82 FR 30122). We proposed to quantify improvement in the cost performance category by comparing the number of cost measures with significant improvement in performance and the number of cost measures with significant declines in performance (82 FR 30122). We proposed at § 414.1380(b)(2)(iv)(C) to determine the cost improvement score by subtracting the number of cost measures with significant declines from the number of cost measures with significant improvement, and then dividing the result by the number of cost measures for which the MIPS eligible clinician or group was scored in both performance periods, and then multiplying the result by the maximum cost improvement score (82 FR 30122). For the 2020 MIPS payment year, improvement scoring would be possible for the total per capita cost measure and the MSPB measure as those 2 measures would be available for 2 consecutive performance periods under the proposals in the CY 2018 Quality Payment Program proposed rule (82 FR 30122). As in our proposed quality improvement methodology, we proposed at § 414.1380(b)(2)(iv)(D) that the cost improvement score could not be lower than zero, and therefore, could only be positive (82 FR 30122).
We proposed to determine whether there was a significant improvement or decline in performance between the two performance periods by applying a common standard statistical test, a t-test, as is used in the Shared Savings Program (79 FR 67930 through 67931, 82 FR 30122). We also welcomed public comments on whether we should consider instead adopting an improvement scoring methodology that measures improvement in the cost performance category the same way we proposed to do in the quality performance category; that is, using the rate of improvement and without requiring statistical significance which was discussed in the CY 2018 Quality Payment Program proposed rule (82 FR 30113 through 30114).
Section 1848(q)(5)(D)(ii) of the Act specifies that the Secretary may assign a higher scoring weight under subparagraph (F) with respect to the achievement of a MIPS eligible clinician than with respect to any improvement
In the CY 2018 Quality Payment Program proposed rule, we considered an alternative to make no changes to the previously finalized weight of 10 percent for the cost performance category for the 2020 MIPS payment year. We proposed that if we maintain a weight of 10 percent for the cost performance category for the 2020 MIPS payment year, the maximum cost improvement score available in the cost performance category would be 1 percentage point out of 100 percentage points available for the cost performance category percent score (82 FR 30122). If a clinician were measured on only one measure consistently from one performance period to the next and met the requirements for improvement, the clinician would receive one improvement percentage point in the cost performance category percent score. If a clinician were measured on 2 measures consistently, improved significantly on one, and did not show significant improvement on the other (as measured by the t-test method described above), the clinician would receive 0.5 improvement percentage points.
We invited comments on these proposals, as well as alternative ways to measure changes in statistical significance for the cost measure.
The following is a summary of the public comments received on these proposals and our responses:
We recognize that some clinicians will not have cost measures available and applicable during the 2018 MIPS performance period and, therefore, will be unable to demonstrate improvement in either the 2018 or 2019 MIPS performance periods. However, we wish to reward clinicians who do achieve improvement and who are measured using the same identifier on the same measure in consecutive years. We will evaluate changes to the maximum cost improvement score for future years in future rulemaking.
For the cost performance category, we proposed to evaluate improvement at the measure level, unlike the quality performance category where we proposed to evaluate improvement at the performance category level. For both the quality performance category and the cost performance category, we proposed to add improvement to an existing category percent score. We noted that we believe this is the most straight-forward and simple way to incorporate improvement. It is also consistent with other Medicare programs that reward improvement.
As noted in the CY 2018 Quality Payment Program proposed rule, we proposed a change in terminology to express the cost performance category percent score as a percentage (82 FR 30123). We proposed to revise § 414.1380(b)(2)(iii) to provide that a MIPS eligible clinician's cost performance category percent score is the sum of the following, not to exceed 100 percent: The total number of achievement points earned by the MIPS eligible clinician divided by the total number of available achievement points (which can be expressed as a percentage); and the cost improvement score (82 FR 30123). With these two proposed changes, the formula would be:
We provided an example of cost performance category scores with the determination of improvement and decline in Table 32 of the proposed rule (82 FR 30123). We invited public comments on these proposals.
The following is a summary of the public comments received on these proposals and our responses:
In Table 25, we provide an example of cost performance category percent scores along with the determination of improvement or decline. This example is for group reporting where the group is measured on both the total per capita cost measure and the MSPB measure for 2 consecutive performance periods.
In this example, there are 20 total possible measure achievement points and 14.6 measure achievement points earned by the group, and the group improved on one measure but not the other, with both measures being scored in each performance period. The first part of the formula is calculating (Cost Achievement Points/Available Cost Achievement Points) which is 14.6/20, which equals .730 and can be represented as 73.0 percent. The cost improvement score will be determined as follows: ((1 measure with significant improvement−zero measures with significant decline)/2 measures) * 1 percentage point = 0.5 percentage points. Under the formula, the cost performance category percent score will be (14.6/20 or 73.0 percent) + 0.5 percent = 73.5 percent. To determine how many points the cost performance category contributes to the final score, we will multiply the performance category percent score (73.5 percent) by the weight of the cost performance category (10 percent of the final score) and by 100 to determine the points to the final score. The group would have 73.5 percent × 10 percent × 100 = 7.35 points for the cost performance category contributed towards the final score.
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 for inpatient hospitals, for purposes of the quality and cost performance categories. However, the Secretary may not 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 (80 FR 59108), we sought comment on how we could best use this authority. We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77127) for a summary of these comments.
As noted in the CY 2017 Quality Payment Program proposed rule (81 FR 28192), we considered 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. However, we did not propose an option for the transition year of MIPS because there were several operational considerations that we believed needed to be addressed before this option could be implemented. At that time, we requested comments on the following issues: (1) Whether we should attribute a facility's performance to a MIPS eligible clinician for purposes of the quality and cost performance categories and under what conditions such attribution would be appropriate and representative of the MIPS eligible clinician's performance; (2) possible
We believe that facility-based measurement is intended to reduce reporting burden on facility-based MIPS eligible clinicians by leveraging existing quality data sources and value-based purchasing experiences and aligning incentives between facilities and the MIPS eligible clinicians who provide services there. In addition, we believe that facility-based MIPS eligible clinicians contribute substantively to their respective facilities' performance on facility-based measures of quality and cost, and that their performance may be better reflected by their facilities' performance on such measures.
We proposed to limit facility-based reporting to the inpatient hospital in the first year for a number of reasons, including that there is a more diverse group of clinicians (and specialty types) providing services in an inpatient setting compared to other settings and that the Hospital Value-Based Purchasing (VBP) Program adjusts payment in connection with both increases and decreases in performance. The Hospital VBP Program is large and mature (82 FR 30124). We also proposed to only use measures from a pay-for-performance program and not a pay-for-reporting program and proposed to limit the measures for facility-based measurement to those used in the Hospital VBP Program (82 FR 30124) because it compares facilities on a series of different measures intended to capture the breadth of care in the facility.
We also considered program timing when determining what Hospital VBP Program year to use for facility-based measurement for the 2020 MIPS payment year. Quality measurement for the FY 2019 Hospital VBP Program's performance period will be concluded by December 31, 2017 (we refer readers to the finalized FY 2019 performance periods in the FY 2018 Inpatient Prospective Payment System/Long-Term Care Hospital Prospective Payment System final rule (82 FR 38259 through 38260)), and the Hospital VBP Program scoring reports (referred to as the Percentage Payment Summary Reports) will be provided to participating hospitals not later than 60 days prior to the beginning of FY 2019, pursuant to the Hospital VBP Program's statutory requirement at section 1886(o)(8) of the Act. We discuss eligibility for facility-based measurement in the CY 2018 Quality Payment Program proposed rule (82 FR 30125 through 30126), and we noted that the determination of the applicable hospital will be made on the basis of a period that overlaps with the applicable Hospital VBP Program performance period. Although Hospital VBP Program measures have different measurement periods, the FY 2019 measures all overlap from January to June in 2017, which also overlaps with our first 12-month period to determine MIPS eligibility for purposes of the CY 2018 performance period and 2020 MIPS payment year.
We believe that MIPS eligible clinicians electing the facility-based measurement option under MIPS should be able to consider as much information as possible when making that decision, including how their attributed hospital performed in the Hospital VBP Program because an individual clinician is a part of the clinical team in the hospital, rather than the sole clinician responsible for care as tracked by quality measures. Therefore, we concluded that we should be as transparent as possible with MIPS eligible clinicians about their potential facility-based scores before they begin data submission for the MIPS performance period since this policy option is intended to minimize reporting burdens on clinicians that are already participating in quality improvement efforts through other CMS programs. We expect that MIPS eligible clinicians that would consider facility-based scoring would generally be aware of their hospital's performance on its quality measures, but believe that providing this information directly to clinicians ensures that such clinicians are fully aware of the implications of their scoring elections under MIPS. However, we noted that this policy could conceivably place non-facility-based MIPS eligible clinicians at a competitive disadvantage since they would not have any means by which to ascertain their MIPS measure scores in advance. We viewed that compromise as a necessity to maximize transparency, and we requested comment on whether this notification in advance of the conclusion of the MIPS performance period is appropriate, or if we should consider notifying facility-based clinicians later in the MIPS performance period or even after its conclusion.
The performance periods proposed in the CY 2018 Quality Payment Program proposed rule (82 FR 30034) for the 2020 MIPS payment year occur in part in 2018, with data submission for most mechanisms starting in January 2019. To provide potential facility-based scores to clinicians by the time the data submission period for the 2018 MIPS performance period begins (assuming that timeframe is operationally feasible), we noted that we believe that the FY 2019 Hospital VBP Program, including the corresponding performance periods, is the most appropriate program year to use for purposes of facility-based measurement under the quality and cost performance categories for the 2020 MIPS payment year. However, we noted also that Hospital VBP Program performance periods can run for periods as long as 36 months, and for some FY 2019 Hospital VBP Program measures, the performance period begins in 2014. We requested comment on whether this lengthy performance period duration should outweigh our desire to include all Hospital VBP Program measures as discussed further below (82 FR 30125). We proposed at § 414.1380(e)(6)(iii) that the performance period for facility-based measurement is the performance period for the measures for the measures adopted under the value-based purchasing program of the facility of the year specified (82 FR 30125).
We considered whether we should include the entire set of Hospital VBP Program measures for purposes of facility-based measurement under MIPS or attempt to differentiate those which may be more influenced by clinicians' contribution to quality performance than others. However, we believe that clinicians have a broad and important role as part of the healthcare team at a hospital and that attempting to differentiate certain measures undermines the team-based approach of facility-based measurement. We proposed at § 414.1380(e)(6)(i) that the quality and cost measures are those adopted under the value-based purchasing program of the facility program for the year specified (82 FR 30125).
We proposed for the 2020 MIPS payment year to include all the measures adopted for the FY 2019 Hospital VBP Program on the MIPS list of quality measures and cost measures (82 FR 30125). Under the proposal, we considered the FY 2019 Hospital VBP Program measures to meet the definition
We requested comments on these proposals. We also requested comments on what other programs, if any, we should consider including for purposes of facility-based measurement under MIPS in future program years (82 FR 30125).
The following is a summary of the public comments received on the “Facility-Based Measurement” proposals and our responses:
However, we are concerned that we might not have the operational ability to inform these clinicians soon enough during the MIPS performance period in 2018 for them to know that they could select facility-based measurement as opposed to another method. We also believe that the comments reflect some lack of understanding of how elements of the policy might apply to clinicians that may qualify for facility-based measurement. We plan to use this additional year for outreach and, if technically feasible, informing clinicians if they would have met the requirements for facility-based measurement based on the finalized policy and what their scoring might have been based on an attributed hospital. We believe this additional year of outreach will best prepare clinicians to make decisions about participating in facility-based measurement. As discussed in section II.C.7.a.(4)(c) of this final rule with comment period, the use of facility-based measurement will be available for individual clinicians and groups. Therefore, we are finalizing the introductory text at § 414.1380(e) with a minor change to refer to “a MIPS eligible clinician or group” in place of “MIPS eligible clinicians” in the proposed text. We discuss the election in section II.C.7.a.(4)(e) of this final rule with comment period.
The percentage of professional time a clinician spends working in a hospital varies considerably. Some clinicians may provide services in the hospital regularly, but also treat patients extensively in an outpatient office or another environment. Other clinicians may practice exclusively within a hospital. Recognizing the various levels of presence of different clinicians within a hospital environment, we proposed to limit the potential applicability of facility-based measurement to those MIPS eligible clinicians with a significant presence in the hospital.
In the CY 2017 Quality Payment Program final rule (81 FR 77238 through 77240), we adopted a definition of “hospital-based MIPS eligible clinician” under § 414.1305 for purposes of the advancing care information performance category. Section 414.1305 defines 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 POS codes used in the HIPAA standard transaction as an inpatient hospital, on-campus outpatient hospital, or emergency room setting, based on Medicare Part B claims for a period prior to the performance period as specified by CMS. We considered whether we should simply use this definition to determine eligibility for facility-based measurement under MIPS. However, we expressed concern that this definition could include many clinicians that have limited or no presence in the inpatient hospital setting. We discuss the differences between the approach of defining hospital-based clinicians for the purposes of the advancing care information category and defining facility-based measurement in the CY 2018 Quality Payment Program proposed rule. (82 FR 30125 through 30126) The measures used in the Hospital VBP Program are focused on care provided in the inpatient setting. We noted that we do not believe it is appropriate for a MIPS eligible clinician to use a hospital's Hospital VBP Program performance for MIPS scoring if the clinician did not provide services in the inpatient setting or in the emergency department, through which many inpatients arrive at the inpatient setting.
We stated our belief that establishing a definition for purposes of facility-based measurement that is different from the hospital-based definition used
Based on those background considerations, we proposed at § 414.1380(e)(2)(i) that a MIPS eligible clinician is considered facility-based as an individual if the MIPS eligible clinician furnishes 75 percent or more of their covered professional services (as defined in section 1848(k)(3)(A) of the Act) in sites of service identified by the POS codes used in the HIPAA standard transaction as an inpatient hospital, as identified by POS code 21, or an emergency room, as identified by POS code 23, based on claims for a period prior to the performance period as specified by CMS (82 FR 30126). We understand that the services of some clinicians who practice solely in the hospital are billed using place of service codes such as code 22, reflecting an on-campus outpatient hospital for patients who are in observation status. Because there are limits on the length of time a Medicare patient may be seen under observation status, we noted that we believe that these clinicians would still furnish 75 percent or more of their covered professional services using POS code 21, but sought comment on whether a lower or higher threshold of inpatient services would be appropriate. We did not propose to include POS code 22 in determining whether a clinician is facility-based because many clinicians who bill for services using this POS code may work on a hospital campus but in a capacity that has little to do with the inpatient care in the hospital. In contrast, we noted our belief that those who provide services in the emergency room or the inpatient hospital clearly contribute to patient care that is captured as part of the Hospital VBP Program because many patients who are admitted are admitted through the emergency room. We sought comments on whether POS 22 should be included in determining if a clinician is facility-based and how we might distinguish those clinicians who contribute to inpatient care from those who do not. The inclusion of any POS code in our definition is pending technical feasibility to link a clinician to a facility under the method described in section II.C.7.b.(4)(d) of the CY 2018 Quality Payment Program proposed rule (82 FR 30126 through 30127).
We noted that this more limited definition would mean that a clinician who is determined to be facility-based likely would also be determined to be hospital-based for purposes of the advancing care information performance category, because the proposed definition of facility-based is narrower than the hospital-based definition established for that purpose. We proposed to identify clinicians as facility-based (and thus eligible to elect facility-based measurement) through an evaluation of covered professional services between September 1 of the calendar year 2 years preceding the performance period through August 31 of the calendar year preceding the performance period with a 30-day claims run out. For example, for the 2020 MIPS payment year, where we have adopted a performance period of CY 2018 for the quality and cost performance categories, we would use the data available at the end of October 2017 to determine whether a MIPS eligible clinician is considered facility-based under our proposed definition. At that time, those data would include Medicare Part B claims with dates of service between September 1, 2016 and August 31, 2017. If it is not operationally feasible to use claims from this exact time period, we noted that we would use a 12-month period as close as practicable to September 1 of the calendar year 2 years preceding the performance period and August 31 of the calendar year preceding the performance period. This determination would allow clinicians to be made aware of their eligibility for facility-based measurement near the beginning of the MIPS performance period.
We also recognized that in addition to the variation in the percentage of time a clinician is present in the hospital, there is also great variability in the types of services that clinicians perform. We considered whether certain clinicians should be identified as eligible for this facility-based measurement option based on characteristics in addition to their percentage of covered professional services furnished in the inpatient hospital or emergency room setting, such as by requiring a certain specialty such as hospital medicine or by limiting eligibility to those who served in patient-facing roles. However, we noted our belief that all MIPS eligible clinicians with a significant presence in the facility play a role in the overall performance of a facility, and therefore, did not propose to further limit this option based on characteristics other than the percentage of covered professional services furnished in an inpatient hospital or emergency room setting.
The following is a summary of the public comments received on these proposals and our responses:
We proposed at § 414.1380(e)(2) that a MIPS eligible clinician is eligible for facility-based measurement under MIPS if they are determined facility-based as part of a group (82 FR 30126). We proposed at § 414.1380(e)(2)(ii) that a facility-based group is a group in which 75 percent or more of the MIPS eligible clinician NPIs billing under the group's TIN are eligible for facility-based measurement as individuals as defined in § 414.1380(e)(2)(i) (82 FR 30126). We also considered an alternative proposal in which a facility-based group would be a group where the TIN overall furnishes 75 percent or more of its covered professional services (as defined in section 1848(k)(3)(A) of the Act) in sites of service identified by the POS codes used in the HIPAA standard transaction as an inpatient hospital, as identified by POS code 21, or the emergency room, as identified by POS code 23, based on claims for a period prior to the performance period as specified by CMS (82 FR 30126). Groups would be determined to be facility-based through an evaluation of covered professional services between September 1 of the calendar year 2 years preceding the performance period through August 31 of the calendar year preceding the performance period with a 30 day claims run out period (or if not operationally feasible to use claims from this exact time period, a 12-month period as close as practicable to September 1 of the calendar year 2 years preceding the performance period and August 31 of the calendar year preceding the performance period).
We requested comments on our proposal and alternative proposal.
The following is a summary of the public comments received on the “Facility-Based Measurement Group Participation” proposals and our responses:
Many MIPS eligible clinicians provide services at more than one hospital, so we need a method to identify which hospital's scores should be associated with each MIPS eligible clinician that elects facility-based measurement under this option. We considered whether a clinician should be required to identify for us the hospital with which the clinician is affiliated, but believe that such a requirement would add unnecessary administrative burden in a process that we believe was intended to reduce burden. We also considered whether we could combine scores from multiple hospitals, but noted our belief that such a combination would reduce the alignment between a single hospital and a clinician or group and could be confusing for participants. We further noted that we believed we must establish a reasonable threshold for a MIPS eligible clinician's participation in clinical care at a given facility to allow that MIPS eligible clinician to be scored using that facility's measures. We noted that we do not believe it to be appropriate to allow MIPS eligible clinicians to claim credit for facilities' measures if the MIPS eligible clinician does not participate meaningfully in the care provided at the facility.
Therefore, we proposed at § 414.1380(e)(5) that MIPS eligible clinicians who elect facility-based measurement would receive scores derived from the value-based purchasing score (using the methodology described in section II.B.7.b.4. of the CY 2018 Quality Payment Program proposed rule (82 FR 30128 through 30129) for the facility at which they provided services for the most Medicare beneficiaries during the period of September 1 of the calendar year 2 years preceding the performance period through August 31 of the calendar year preceding the performance period with a 30-day claims run out (82 FR 30127). This period for identifying the facility whose performance will be attributed to a facility-based clinician (or group) is the same as the time period for services we will use to determine if a clinician (or group) is eligible for facility-based measurement; this time period also overlaps with parts of the performance period for the applicable Hospital VBP Program measures. We proposed that for the first year, the value-based purchasing score for the facility would be the FY 2019 Hospital VBP Program's Total Performance Score. In cases in which there was an equal number of Medicare beneficiaries treated at more than one facility, we proposed to use the value-based purchasing score from the facility with the highest score (82 FR 30127).
The following is a summary of the public comments received on these proposals and our responses:
We proposed at § 414.1380(e)(3) that individual MIPS eligible clinicians or groups who wish to have their quality and cost performance category scores determined based on a facility's performance must elect to do so through an attestation. We proposed that those clinicians or groups who are eligible for and wish to elect facility-based measurement would be required to submit their election during the data submission period as determined at § 414.1325(f) through the attestation submission mechanism established for the improvement activities and advancing care information performance categories. (82 FR 30127). We further proposed that, if technically feasible, we would let the MIPS eligible clinician know that they were eligible for facility-based measurement prior to the submission period, so that MIPS eligible clinicians would be informed if this option is available to them.
We also considered an alternative approach of not requiring an election process but instead automatically applying facility-based measurement to MIPS eligible clinicians and groups who are eligible for facility-based measurement, if technically feasible. Under this approach, we would calculate a MIPS eligible clinician's facility-based measurement score based on the hospital's (as identified using the process described in section II.C.7.a.(4)(d) of the CY 2018 Quality Payment Program proposed rule (82 FR 30126 through 30127)) performance using the methodology described in section II.C.7.a.(4)(f) of the CY 2018 Quality Payment Program proposed rule (82 FR 30128 through 30132), and automatically use that facility-based measurement score for the quality and cost performance category scores if the facility-based measurement score is higher than the quality and cost performance category scores as determined based on data submitted by the MIPS eligible clinician or group through any available reporting mechanism. This facility-measurement score would be calculated even if an individual MIPS eligible clinician or group did not submit any data for the quality performance category. We explained how this alternative approach might work in the CY 2018 Quality Payment Program proposed rule in connection with choosing the time period of the hospital performance in the Hospital VBP Program (82 FR 30127). We noted our concern that a method that does not require active selection may result in MIPS eligible clinicians being scored on measures at a facility and being unaware that such scoring is taking place. We also expressed concern that such a method could provide an advantage to those facility-based clinicians who do not submit quality measures in comparison to those who work in other environments. We also noted that this option may not be technically feasible for us to implement for the 2018 MIPS performance period.
We invited comments on this proposal and alternate proposal.
The following is a summary of the public comments received on these proposals and our responses:
In light of our interest in reducing burden, we do prefer an option that would not require a clinician or practice to notify CMS through attestation or other method. We therefore seek comment on whether a process by which a clinician or group would be automatically assigned a score under facility-based measurement but be notified and given the opportunity to
For FY 2019, the Hospital VBP Program has adopted 12 quality and efficiency measures. The Hospital VBP Program currently includes 4 domains: Person and community engagement, clinical care, safety, and efficiency and cost reduction. These domains align with many MIPS high priority measures (outcome, appropriate use, patient safety, efficiency, patient experience, and care coordination measures) in the quality performance category and the efficiency and cost reduction domain closely aligns with our cost performance category. We believe this set of measures covering 4 domains and composed primarily of measures that would be considered high priority under the MIPS quality performance category capture a broad picture of hospital-based care. Additionally, the Hospital VBP Program has adopted several measures of clinical outcomes in the form of 30-day mortality measures, and clinical outcomes are a high-priority topic for MIPS. The Hospital VBP Program includes several measures in a safety domain, which meets our definition of patient safety measures as high-priority. Therefore, we proposed that facility-based individual MIPS eligible clinicians or groups that are attributed to a hospital would be scored on all the measures on which the hospital is scored for the Hospital VBP Program via the Hospital VBP Program's Total Performance Score scoring methodology (82 FR 30127).
The Hospital VBP Program's FY 2019 measures, and their associated performance periods, were reproduced in Table 33 in the proposed rule (82 FR 30128). Here, we are including, in Table 26, a list of the finalized FY2019 Hospital VBP Program Measures.
We noted that the Patient Safety Composite Measure (PSI-90) was proposed for removal beginning with the FY 2019 measure set in the FY 2018 Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System (IPPS/LTCH PPS) proposed rule (82 FR 19970) due to issues with calculating the measure score and that we would remove the measure from the list of those adopted for facility-based measurement in the MIPS program if that proposal was finalized. The proposal to remove the PSI-90 measure was finalized in the FY 2018 IPPS/LTCH PPS final rule (82 FR 38244).
We proposed at § 414.1380(e)(4) that there are no data submission requirements for the facility-based measures used to assess performance in the quality and cost performance categories, other than electing the option through attestation as proposed in the CY 2018 Quality Payment Program proposed rule (82 FR 30128).
The following is a summary of the public comments received on the “Facility-Based Measures” proposals and our responses:
When developing our facility-based measurement policy under MIPS, we also took into account our beliefs that aligning incentives and informing clinicians about their opportunity to participate in MIPS outweighs the interest in aligning the performance period between the Hospital VBP Program and MIPS. We believe that we must encourage participation in MIPS, and we view the facility-based measurement option as one policy that enables us to so encourage participating clinicians. We will consider ways to align performance periods between the Hospital VBP Program and the Quality Payment Program in the future.
We believe that the policy approach of using all measures from a value-based purchasing program is appropriate. However, we are not adopting these
We are finalizing our proposal at § 414.1380(e)(4) with modification to state that there are no data submission requirements for clinicians for the facility-based measures used to assess performance in the quality and cost performance categories. Because we have not finalized a method of electing facility-based measurement in § 414.1380(e)(3), we are deleting the phrase “other than electing the option through attestation as described in paragraph (e)(3) of this section”. In addition, we are revising the text to clarify that the lack of data submission requirements is for individual clinicians and groups of clinicians, rather than a statement about the submission by facilities for the facility performance program.
We believe that the Hospital VBP Program represents the most appropriate value-based purchasing program with which to begin implementation of the facility-based measurement option under MIPS. We offered a summary of the Hospital VBP Program scoring and compared it to MIPS scoring in the CY 2018 Quality Payment Program proposed rule (82 FR 30128 through 30129).
We summarized in the proposed rule (82 FR 30129) what we considered prior to proposing at § 414.1380(e) that facility-based scoring be available for cost and quality performance categories. We considered several methods to incorporate facility-based measures into scoring for the 2020 MIPS payment year, including selecting hospitals' measure scores, domain scores, and the Hospital VBP Program Total Performance Scores to form the basis for the cost and quality performance category scores for individual MIPS eligible clinicians and groups that are eligible to participate in facility-based measurement. We proposed the option that we believed provided the fairest comparison between performance in the 2 programs and would best allow us to expand the opportunity to other programs in the future.
Unlike MIPS, the Hospital VBP Program does not have performance categories. There are instead four domains of measures. We considered whether we should try to identify certain domains or measures that were more closely aligned with those identified in the quality performance category or the cost performance category. We also considered whether we should limit the application of facility-based measurement to the quality performance category and calculate the cost performance category score as we do for other clinicians. However, we believe that value-based purchasing programs are generally constructed to assess an overall picture of the care provided by the facility, taking into account both the costs and the quality of care provided. Given our focus on alignment between quality and cost, we also do not believe it is appropriate to measure quality on one unit (a hospital) and cost on another (such as an individual clinician or TIN). Therefore, we proposed at § 414.1380(e) that facility-based scoring is available for the quality and cost performance categories and that the facility-based measurement scoring standard is the MIPS scoring methodology applicable for those who meet facility-based eligibility requirements and who elect facility-based measurement.
The following is a summary of the public comments received on “Applying Hospital VBP Program Scoring to the MIPS Quality and Cost Performance Categories” proposals and our responses:
Measures in the MIPS quality performance category are benchmarked to historical performance on the basis of performance during the 12-month calendar year that is 2 years prior to the performance period for the MIPS payment year. If a historical benchmark cannot be established, a benchmark is calculated during the performance period. In the cost performance category, benchmarks are established during the performance period because changes in payment policies year to year can make it challenging to compare performance on cost measure year to year. Although we proposed a different performance period for MIPS eligible clinicians in facility-based measurement, the baseline period used for creating MIPS benchmarks is generally consistent with this approach. We noted that the Hospital VBP Program uses measures for the same fiscal year even if those measures do not have the same performance period length, but the baseline period closes well before the performance period. The MSPB is benchmarked in a manner that is similar to measures in the MIPS cost performance category. The MSPB only uses a historical baseline period for improvement scoring and bases its achievement threshold and benchmark solely on the performance period (81 FR
Performance measurement in the Hospital VBP Program and MIPS is quite different in part due to the design and the maturity of the programs. The Hospital VBP Program only assigns achievement points to a hospital for its performance on a measure if the hospital's performance during the performance period meets or exceeds the median of hospital performance on that measure during the applicable baseline period (or in the case of the MSPB measure, if the hospital's performance during the performance period meets or exceeds the median of hospital performance during that period), whereas MIPS assigns achievement points to all measures that meet the required data completeness and case minimums. In addition, the Hospital VBP Program has removed many process measures and topped out measures since its first program year (FY 2013), while both process and topped out measures are available in MIPS. With respect to the FY 2017 program year, for example, the median Total Performance Score for a hospital in Hospital VBP Program was 33.88 out of 100 possible points. If we were to simply assign the Hospital VBP Program Total Performance Score for a hospital to a clinician, the performance of those MIPS eligible clinicians electing facility-based measurement would likely be lower than most who participated in the MIPS program, particularly in the quality performance category.
We noted that we believe that we should recognize relative performance in the facility programs that reflect their different designs. Therefore, we proposed at § 414.1380(e)(6)(iv) that the quality performance category score for facility-based measurement is reached by determining the percentile performance of the facility determined in the value-based purchasing program for the specified year as described under § 414.1380(e)(5) and awarding a score associated with that same percentile performance in the MIPS quality performance category score for those clinicians who are not scored using facility-based measurement (82 FR 30130). We also proposed at § 414.1380(e)(6)(v) that the cost performance category score for facility-based measurement is established by determining the percentile performance of the facility determined in the value-based purchasing program for the specified year as described in § 414.1380(e)(5) and awarding the number of points associated with that same percentile performance in the MIPS cost performance category score for those clinicians who are not scored using facility-based measurement (82 FR 30130). (In the context of our proposal, this year would have been the FY 2019 year for the Hospital VBP program, as we proposed in section II.C.7.a.(4)(e) to use that as the attributed performance for MIPS eligible clinicians and groups that elected facility-based measurement.) For example, if the median Hospital VBP Program Total Performance Score was 35 out of 100 possible points and the median quality performance category percent score in MIPS was 75 percent and the median cost performance category score was 50 percent, then a clinician or group that is evaluated based on a hospital that received an Hospital VBP Program Total Performance Score of 35 points would receive a score of 75 percent for the quality performance category and 50 percent for the cost performance category. The percentile distribution for both the Hospital VBP Program and MIPS would be based on the distribution during the applicable performance periods for each of the programs and not on a previous benchmark year.
We noted in the proposed rule our belief that the proposal offers a fairer comparison of the performance among participants in MIPS and the Hospital VBP Program compared to other options we considered and provides an objective means to normalize differences in measured performance between the programs. In addition, we noted that this method will make it simpler to apply the concept of facility-based measurement to additional programs in the future.
The following is a summary of the public comments received on the “Assigning MIPS Performance Category Scores based on Hospital VBP Performance” proposals and our responses:
The Hospital VBP Program includes a methodology for recognizing improvement on individual measures which is then incorporated into the total performance score for each participating hospital. A hospital's performance on a measure is compared to a national benchmark, as well as its own performance from a corresponding baseline period.
We proposed to consider improvement in the quality and cost performance categories. In the CY 2018 Quality Payment Program proposed rule (82 FR 30113), we proposed to measure improvement in the quality performance category based on improved achievement for the performance category percent score and award improvement even if, under certain circumstances, a clinician moves from one identifier to another from 1 year to the next. For those who may be measured under facility-based
Because we indicated our intention to allow clinicians the flexibility to elect facility-based measurement on an annual basis, we noted that some clinicians may be measured through facility-based measurement in 1 year and through another MIPS method in the next. We sought comment on how to assess improvement for those that switch from facility-based scoring to another MIPS method in a later year. We requested comment on whether it is appropriate to include measurement of improvement in the MIPS quality performance category for MIPS eligible clinicians and groups that use facility-based measures given that the Hospital VBP Program already takes improvement into account in its scoring methodology (82 FR 30130).
In the CY 2018 Quality Payment Program proposed rule, we discussed our proposal to measure improvement in the cost performance category at the measure level (82 FR 30121). We proposed that clinicians under facility-based measurement would not be eligible for a cost improvement score in the cost performance category (82 FR 30130). As in the quality performance category, we believe that a clinician participating in facility-based measurement in subsequent years would already have improvement recognized as part of the Hospital VBP Program methodology and therefore, should not be given additional credit. In addition, because we proposed to limit measurement of improvement to those MIPS eligible clinicians that participate in MIPS using the same identifier and are scored on the same cost measure(s) in 2 consecutive performance periods, those MIPS eligible clinicians who elect facility-based measurement would not be eligible for a cost improvement score in the cost performance category under the proposed methodology because they would not be scored on the same cost measure(s) for 2 consecutive performance periods.
The following is a summary of the public comments received on the “Scoring Improvement for Facility-Based Measurement” proposals and our responses:
MIPS eligible clinicians that report on quality measures are eligible for bonus points for the reporting of additional outcome and high priority measures beyond the one that is required. Two bonus points are awarded for each additional outcome or patient experience measure, and one bonus point is awarded for each additional other high priority measure. These bonus points are intended to encourage the use of measures that are more impactful on patients and better reflect the overall goals of the MIPS program. Many of the measures in the Hospital VBP Program meet the criteria that we have adopted for high-priority measures. We support measurement that takes clinicians' focus away from clinical process measures; however, the proposed scoring method described above is based on a percentile distribution of scores within the quality and cost performance categories that already accounts for bonus points. For this reason, we did not propose to calculate additional high priority bonus points for facility-based measurement.
We noted that clinicians have an additional opportunity to receive bonus points in the quality performance category score for using end-to-end electronic submission of quality measures. The Hospital VBP Program does not capture whether or not measures are reported using end-to-end electronic reporting; however, our proposed facility-based scoring method described above is based on a percentile distribution of scores within the quality and cost performance categories. Because the MIPS quality performance category scores already account for bonus points, including end-to-end electronic reporting, when we translate the Total Performance Score, the overall effect of end-to-end electronic reporting would be captured in the translated score. For this reason, we did not propose to calculate additional end-to-end electronic reporting bonus points for facility-based measurement.
The following is a summary of the public comments received on the “Bonus Points for Facility-Based Measurement” proposals and our responses:
Some hospitals do not receive a Total Performance Score in a given year in the Hospital VBP Program, whether due to insufficient quality measure data, failure to meet requirements under the Hospital IQR Program, or other reasons. In these cases, we would be unable to calculate a facility-based score based on the hospital's performance, and facility-based clinicians would be required to participate in MIPS via another method. Most hospitals which do not receive a Total Performance Score in the Hospital VBP Program are routinely excluded, such as hospitals in Maryland. In such cases, facility-based clinicians would know well in advance that the hospital would not receive a Total Performance Score, and that they would need to participate in MIPS through another method. However, we noted that we are concerned that some facility-based clinicians may provide services in hospitals which they expect will receive a Total Performance Score but do not due to various rare circumstances such as natural disasters. In the CY 2018 Quality Payment Program proposed rule (82 FR 30142 through 30143) we proposed a process for requesting a reweighting assessment for the quality, cost and improvement activities performance categories due to extreme and uncontrollable circumstances, such as natural disasters. We proposed that MIPS eligible clinicians who are facility-based and affected by extreme and uncontrollable circumstances, such as natural disasters, may apply for reweighting (82 FR 30131).
In addition, we noted that hospitals may submit correction requests to their Total Performance Scores calculated under the Hospital VBP Program, and may also appeal the calculations of their Total Performance Scores, subject to Hospital VBP Program requirements established in prior rulemaking. Our proposal was to use the final Hospital VBP Program Total Performance Score for the facility-based measurement option under MIPS. In the event that a hospital obtains a successful correction or appeal of its Total Performance Score, we would update MIPS eligible clinicians' quality and cost performance category scores accordingly, as long as the update could be made prior to the application of the MIPS payment adjustment for the relevant MIPS payment year.
Additionally, although we wish to tie the hospital and clinician performance as closely together as possible for purposes of the facility-based scoring policy, we do not wish to disadvantage those clinicians and groups that select this measurement method. In the CY 2018 Quality Payment Program proposed rule, we proposed to retain a policy equivalent to the 3-point floor for all measures with complete data in the quality performance category scored against a benchmark in the 2020 MIPS payment year (82 FR 30131). However, the Hospital VBP Program does not have a corresponding scoring floor. Therefore, we proposed to adopt a floor on the Hospital VBP Program Total Performance Score for purposes of facility-based measurement under MIPS so that any score in the quality performance category, once translated into the percentile distribution described above, that would result in a score of below 30 percent would be reset to a score of 30 percent in the quality performance category (82 FR 30131). We believe that this adjustment is important to maintain consistency with our other policies. There is no similar floor established for measures in the cost performance category under MIPS, so we did not propose any floor for the cost performance category for facility-based measurement.
Some MIPS eligible clinicians who select facility-based measurement could have sufficient numbers of attributed patients to meet the case minimums for the cost measures established under MIPS. Although there is no additional data reporting for cost measures, we believe that, to facilitate the relationship between cost and quality measures, they should be evaluated covering the same population as opposed to comparing a hospital population and a population attributed to an individual clinician or group. In addition, we believe that including additional cost measures in the cost performance category score for MIPS eligible clinicians who elect facility-based measurement would reduce the alignment of incentives between the hospital and the clinician. Thus, we proposed at § 414.1380(e)(6)(v)(A) that MIPS eligible clinicians who elect facility-based measurement would not be scored on other cost measures specified for the cost performance category, even if they meet the case minimum for a cost measure (82 FR 30131).
If a clinician or a group elects facility-based measurement but also submits quality data through another MIPS mechanism, we proposed to use the higher of the two scores for the quality performance category and base the score of the cost performance category on the same method (that is, if the facility-based quality performance category score is higher, facility-based measurement is used for quality and cost) (82 FR 30131). Since this policy may result in a higher final score, it may provide facility-based clinicians with a substantial incentive to elect facility-based measurement, whether or not the clinician believes such measures are the most accurate or useful measures of that clinician's performance. Therefore, this policy may create an advantage for facility-based clinicians over non-facility-based clinicians, since non-facility-based clinicians would not have the opportunity to use the higher of two scores. Therefore, we sought comment on whether this proposal to use the higher score is the best approach to score the performance of facility-based clinicians in comparison to their non-facility-based peers (82 FR 30131).
The following is a summary of the public comments received on the “Special Rules for Facility-Based Measurement” proposals and our responses:
Section 1848(q)(5)(C) of the Act specifies scoring rules for the improvement activities performance category. For more of the statutory background and description of the proposed and finalized policies, we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77311 through 77319). We have also codified certain requirements for the improvement activities performance category at § 414.1380(b)(3). Based on these criteria, we finalized at § 414.1380(b)(3) in the CY 2017 Quality Payment Program final rule the scoring methodology for this category, which assigns points based on certified patient-centered medical home participation or comparable specialty practice participation, APM participation, and the improvement activities reported by the MIPS eligible clinician (81 FR 77312). A MIPS eligible clinician's performance will be evaluated by comparing the reported improvement activities to the highest possible score (40 points). In the CY 2018 Quality Payment Program proposed rule (82 FR 30132), we did not propose any changes to the scoring of the improvement activities performance category.
We assign points for each reported improvement activity within 2 categories: Medium-weighted; and high-weighted activities. Generally, each medium-weighted activity is worth 10 points toward the total category score of 40 points, and each high-weighted activity is worth 20 points toward the total category score of 40 points. These points are doubled for small practices, practices in rural areas, or practices located in geographic HPSAs, and non-patient facing MIPS eligible clinicians. We refer readers to § 414.1380(b)(3) and the CY 2017 Quality Payment Program final rule (81 FR 78312) for further detail on improvement activities scoring.
Activities will 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 consistent with 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 (81 FR 77311). Additionally, activities that require performance of multiple actions, such as participation in the Transforming Clinical Practice Initiative (TCPI), participation in a MIPS eligible 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) are justifiably weighted as high (81 FR 77311 through 77312).
We refer readers to Table 26 of the CY 2017 Quality Payment Program final rule for a summary of the previously finalized improvement activities that are weighted as high (81 FR 77312 through 77313), and to Table H of the same final rule, for a list of all the previously finalized improvement activities, both medium- and high-weighted (81 FR 77817 through 77831). We also refer readers to Table F and Table G in the appendices of the proposed rule for our proposed additions and changes to the Improvement Activities Inventory for Quality Payment Program Year 2 and future years (82 FR 30479 and 82 FR 30486 respectively). In this final rule with comment period, we are finalizing the proposed new activities and changes to previously adopted activities, some with modification, and refer readers to the tables in the appendices of this final rule with comment period for details. Consistent with our unified scoring system principles, we finalized in the CY 2017 Quality Payment Program final rule that MIPS eligible clinicians will know in advance how many potential points they could receive for each improvement activity (81 FR 77311 through 77319).
At § 414.1380(b)(3), we finalized that we will require a total of 40 points to receive the highest score for the improvement activities performance category (81 FR 77315). For more of the statutory background and description of the proposed and finalized policies, we
For small practices, practices in rural areas or geographic HPSAs, and non-patient facing MIPS eligible clinicians, the weight for any activity selected is doubled so that these practices and eligible clinicians only need to select one high- or two medium-weighted activities to achieve the highest score of 40 points (81 FR 77312).
In accordance with section 1848(q)(5)(C)(ii) of the Act, we codified at § 414.1380(b)(3)(ix) that individual 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 will automatically earn at least one half of the highest potential score for the improvement activities performance category for the performance period (81 FR 30132). In addition, MIPS eligible clinicians that are participating in MIPS APMs are assigned an improvement activity score, which may be higher than one half of the highest potential score (81 FR 30132). This assignment is based on the extent to which the requirements of the specific model meet the list of activities in the Improvement Activities Inventory (81 FR 30132). For a further description of improvement activities and the APM scoring standard for MIPS, we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77246). For all other individual MIPS eligible clinicians or groups, we refer readers to the scoring requirements for individual MIPS eligible clinicians and groups in the CY 2017 Quality Payment Program final rule (81 FR 77270). An individual MIPS eligible clinician or group is not required to perform activities in each improvement activities subcategory or participate in an APM to achieve the highest potential score in accordance with section 1848(q)(5)(C)(iii) of the Act (81 FR 77178).
In the CY 2017 Quality Payment Program final rule, we also finalized that individual MIPS eligible clinicians and groups that successfully participate and submit data to fulfill the requirements for the CMS Study on Improvement Activities and Measurement will receive the highest score for the improvement activities performance category (81 FR 77315). We refer readers to the CY 2018 Quality Payment Program proposed rule (82 FR 30056) and section II.C.6.e.(10) of this final rule with comment period for further detail on this study.
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 for a performance period, as determined by the Secretary, must be given the highest potential score for the improvement activities performance category for the performance period. Accordingly, at § 414.1380(b)(3)(iv), we specified 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 for the improvement activities performance category (81 FR 77196 through 77180).
In the CY 2018 Quality Payment Program proposed rule, we did not propose any changes specifically to the scoring of the patient-centered medical home or comparable specialty practice; however, we did propose a change to how groups qualify for this activity (82 FR 30054). We refer readers to section II.C.6.e.(2)(a) of this final rule with comment period for more details.
In the CY 2017 Quality Payment Program final rule (81 FR 77318), we finalized that individual MIPS eligible clinicians and groups must earn a total of 40 points to receive the highest score for the improvement activities performance category. To determine the improvement activities performance category score, we sum the points for all of a MIPS eligible clinician's reported activities and divide by the improvement activities performance category highest potential score of 40. A perfect score will be 40 points divided by 40 possible points, which equals 100 percent. If MIPS eligible clinicians have more than 40 improvement activities points, we will cap the resulting improvement activities performance category score at 100 percent (81 FR 77318). For example, if more activities are selected than 4 medium-weighted activities, the total points that could be achieved is still 40 points (81 FR 77318). As stated at (81 FR 77318), the following scoring applies to MIPS eligible clinicians generally (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 will result in 10 points which is one- fourth of the highest score.
• Reporting of two medium-weighted activities will result in 20 points which is one- half of the highest score.
• Reporting of three medium-weighted activities will result in 30 points which is three-fourths of the highest score.
• Reporting of four medium-weighted activities will result in 40 points which is the highest score.
• Reporting of one high-weighted activity will result in 20 points which is one-half of the highest score.
• Reporting of two high-weighted activities will 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) (81 FR 78318).
In the CY 2018 Quality Payment Program proposed rule (82 FR 30133), we did not propose any changes to how we will calculate the improvement activities performance category score.
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 PHS 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)(5)(F) 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.
Accordingly, in the CY 2017 Quality Payment Program final rule (81 FR 77318), we finalized that the following scoring applies 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 activity will result in 20 points or one-half of the highest score.
• Reporting of two medium-weighted activities will result in 40 points or the highest score.
• Reporting of one high-weighted activity will result in 40 points or the highest score.
In the CY 2018 Quality Payment Program proposed rule (82 FR 30133), we did not propose any changes to our policy to give consideration to the circumstances of small practices and practices located in rural areas and in geographic HPSAs.
We finalized in the CY 2017 Quality Payment Program final rule that certain activities in the improvement activities performance category will also qualify for a bonus under the advancing care information performance category (81 FR 78318). This bonus is applied under the advancing care information performance category and not under the improvement activities performance category (81 FR 78318). For more information about our finalized improvement activities scoring policies and for several sample scoring charts, we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 78318 through 78319). In the CY 2018 Quality Payment Program proposed rule (82 FR 30059), we did not propose any changes to this policy and refer readers to section II.C.6.f.(2)(d) of this final rule with comment period for more details in the advancing care information performance discussion.
Finally, in the CY 2017 Quality Payment Program final rule (81 FR 77319), we codified at § 414.1380(b)(3)(ix) that MIPS eligible clinicians participating in APMs that are not certified patient-centered medical homes will automatically earn a minimum score of one-half of the highest potential score for the performance category, as required by section 1848(q)(5)(C)(ii) of the Act. For any other MIPS eligible clinician who does not report at least one activity, including a MIPS eligible clinician who does not identify to us that they are participating in a certified patient-centered medical home or comparable specialty practice, we will calculate a score of zero points (81 FR 77319). In the CY 2018 Quality Payment Program proposed rule (82 FR 30132), we did not propose any changes to this policy.
In the CY 2017 Quality Payment Program final rule (81 FR 77319), we established that individual MIPS eligible clinicians or groups participating in APMs would not be required to self-identify as participating in an APM, but that all MIPS eligible clinicians would be required to self-identify if they were 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, and that we would validate these self-identifications as appropriate.
In the CY 2018 Quality Payment Program proposed rule (82 FR 30133), we did not propose any changes to this policy for certified patient-centered medical homes or comparable specialty practices. MIPS eligible clinicians that are part of a certified patient-centered medical home a recognized or certified patient-centered medical home or comparable specialty practice are still required to self-identify for the 2018 MIPS performance period, and we will validate these self-identifications as appropriate.
For the criteria for recognition as a recognized or certified patient-centered medical home or comparable specialty practice, we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77179 through 77180) and section II.C.6.e.(2)a of this final rule with comment period.
However, in the CY 2018 Quality Payment Program proposed rule (82 FR 30133), we proposed to no longer require these self-identifications for non-patient facing MIPS eligible clinicians, small practices, or practices located in rural areas or geographic HPSAs beginning with the 2018 MIPS performance period, because it is technically feasible for us to identify these MIPS eligible clinicians during attestation for the performance of improvement activities following the performance period. We define these MIPS eligible clinicians in the CY 2017 Quality Payment Program final rule (81 FR 77540).
The following is a summary of the public comments received on the “Self-Identification Policy for MIPS Eligible Clinicians” proposals and our responses.
In the CY 2018 Quality Payment Program proposed rule, we referred readers to section II.C.6. of the proposed rule, (82 FR 30057 through 82 FR 30080) where we discussed scoring the advancing care information performance category. We refer readers to section II.C.6.f. of this final rule with comment period for finalized policies related to scoring the advancing care information performance category.
For a description of the statutory basis and our policies for calculating the final score for MIPS eligible clinicians, we refer readers to the discussion in the CY 2017 Quality Payment Program final rule (81 FR 77319 through 77329) and § 414.1380. In the proposed rule, we proposed to add a complex patient scoring bonus (82 FR 30135 through 82 FR 30139) and add a small practice bonus to the final score (82 FR 30139 through 82 FR 30140). In addition, we reviewed the final score calculation for the 2020 MIPS payment year (82 FR
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 Improving Medicare Post-Acute Care Transformation (IMPACT) Act of 2014 and, as appropriate, other information, including information collected before completion of such studies and recommendations.
In this section, we summarize our efforts related to social risk and the relevant studies conducted under section 2(d) of the IMPACT Act of 2014. We also finalize some short-term adjustments to address patient complexity.
We understand that social risk factors such as income, education, race and ethnicity, employment, disability, community resources, and social support (certain factors of which are also sometimes referred to as socioeconomic status (SES) factors or socio-demographic status (SDS) factors) play a major role in health. One of our core objectives is to improve beneficiary outcomes, including reducing health disparities, and we want to ensure that all beneficiaries, including those with social risk factors, receive high quality care. In addition, we seek to ensure that the quality of care furnished by providers and suppliers is assessed as fairly as possible under our programs while ensuring that beneficiaries have adequate access to excellent care.
We have been reviewing reports prepared by the Office of the Assistant Secretary for Planning and Evaluation (ASPE) and the National Academies of Sciences, Engineering, and Medicine on the issue of accounting for social risk factors in CMS's value-based purchasing and quality reporting programs, and considering options on how to address the issue in these programs. On December 21, 2016, ASPE submitted the first of several Reports to Congress on a study it was required to conduct under section 2(d) of the IMPACT Act of 2014. The first study analyzed the effects of certain social risk factors in Medicare beneficiaries on quality measures and measures of resource use used in one or more of nine Medicare value-based purchasing programs.
In addition, the National Quality Forum (NQF) has concluded their initial trial on risk adjustment for quality measures. Based on the findings from the initial trial, NQF will continue its work to evaluate the impact of social risk factor adjustment on intermediate outcome and outcome measures for an additional 3 years. The extension of this work will allow NQF to determine further how to effectively account for social risk factors through risk adjustment and other strategies in quality measurement.
As we continue to consider the analyses and recommendations from these and any future reports, we are continuing to work with stakeholders in this process. As we have previously communicated, we are concerned about holding providers to different standards for the outcomes of their patients with social risk factors because we do not want to mask potential disparities or minimize incentives to improve the outcomes for disadvantaged populations. Keeping this concern in mind, while we sought input on this topic previously, we requested public comment on whether we should account for social risk factors in the MIPS, and if so, what method or combination of methods would be most appropriate for accounting for social risk factors in the MIPS. Examples of methods include: Adjustment of MIPS eligible clinician scores (for example, stratifying the scores of MIPS eligible clinicians based on the proportion of their patients who are dual eligible); confidential reporting of stratified measure rates to MIPS eligible clinicians; public reporting of stratified measure results; risk adjustment of a particular measure as appropriate based on data and evidence; and redesigning payment incentives (for instance, rewarding improvement for clinicians caring for patients with social risk factors or incentivizing clinicians to achieve health equity). We requested comments on whether any of these methods should be considered, and if so, which of these methods or combination of methods would best account for social risk factors in MIPS, if any.
In addition, we requested public comment on which social risk factors might be most appropriate for stratifying measure scores and/or potential risk adjustment of a particular measure. Examples of social risk factors include, but are not limited to the following: Dual eligibility/low-income subsidy; race and ethnicity; and geographic area of residence. We also requested comment on which of these factors, including current data sources where this information would be available, could be used alone or in combination, and whether other data should be collected to better capture the effects of social risk. We noted that we will take commenters' input into consideration as we continue to assess the appropriateness and feasibility of accounting for social risk factors in MIPS. We noted that any such changes would be proposed through future notice and comment rulemaking.
We look forward to working with stakeholders as we consider the issue of accounting for social risk factors and reducing health disparities in CMS programs. Of note, implementing any of the above methods would be taken into consideration in the context of how this and other CMS programs operate (for example, data submission methods, availability of data, statistical considerations relating to reliability of data calculations, among others); we also welcome comment on operational considerations. CMS is committed to ensuring that its beneficiaries have access to and receive excellent care, and that the quality of care furnished by providers and suppliers is assessed fairly in CMS programs.
In response to our requests for comments described previously in this final rule with comment period, many commenters provided feedback on addressing social risk. As we have previously stated, we are concerned
While we work with stakeholders on these issues as we have described, under the authority within section 1848(q)(1)(G) of the Act, which allows us to assess and implement appropriate adjustments to payment adjustments, MIPS final scores, scores for performance categories, or scores for measures or activities under MIPS, we proposed to implement a short-term strategy for the Quality Payment Program to address the impact patient complexity may have on final scores (82 FR 30135 through 82 FR 30139). The overall goal when considering a bonus for complex patients is two-fold: (1) To protect access to care for complex patients and provide them with excellent care; and (2) to avoid placing MIPS eligible clinicians who care for complex patients at a potential disadvantage while we review the completed studies and research to address the underlying issues. We used the term “patient complexity” to take into account a multitude of factors that describe and have an impact on patient health outcomes; such factors include the health status and medical conditions of patients, as well as social risk factors. We believe that as the number and intensity of these factors increase for a single patient, the patient may require more services, more clinician focus, and more resources in order to achieve health outcomes that are similar to those who have fewer factors. In developing the policy for the complex patient bonus, we assessed whether there was a MIPS performance discrepancy by patient complexity using two well-established indicators in the Medicare program. The proposal was intended to address any discrepancy, without masking performance. Because this bonus is intended to be a short-term strategy, we proposed the bonus only for the 2018 MIPS performance period (2020 MIPS payment year) and noted we will assess on an annual basis whether to continue the bonus and how the bonus should be structured (82 FR 30135 through 30139).
When considering approaches for a complex patient bonus, we reviewed evidence to identify how indicators of patient complexity have an impact on performance under MIPS as well as availability of data to implement the bonus. We estimated the impact on performance using our proposed scoring model, described in more detail in the regulatory impact analysis of the CY 2018 Quality Payment Program proposed rule (82 FR 30235 through 30238) that uses historical PQRS data to simulate scores for MIPS eligible clinicians including estimates for the quality, advancing care information, and improvement activities performance categories, and the small practice bonus (82 FR 30149 through 30150). These estimates reflect scoring proposals with the cost performance category weight at zero percent. We identified two potential indicators for complexity: Medical complexity as measured through Hierarchical Condition Category (HCC) risk scores and social risk as measured through the proportion of patients with dual eligible status. We identified these indicators because they are common indicators of patient complexity in the Medicare program and the data is readily available. Please refer to the CY 2018 Quality Payment Program proposed rule for a detailed discussion of our analysis of both indicators that informed our proposal (82 FR 30135 through 30138).
We proposed at § 414.1380(c)(3) to add a complex patient bonus to the final score for the 2020 MIPS payment year for MIPS eligible clinicians that submit data for at least one performance category (82 FR 30138). We proposed at § 414.1380(c)(3)(i) to calculate an average HCC risk score, using the model adopted under section 1853 of the Act for Medicare Advantage risk adjustment purposes, for each MIPS eligible clinician or group, and to use that average HCC risk score as the complex patient bonus. We proposed to calculate the average HCC risk score for a MIPS eligible clinician or group by averaging HCC risk scores for beneficiaries cared for by the MIPS eligible clinician or clinicians in the group during the second 12-month segment of the eligibility period, which spans 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 (September 1, 2017 to August 31, 2018 for the 2018 MIPS performance period). We proposed the second 12-month segment of the eligibility period to align with other MIPS policies and to ensure we have sufficient time to determine the necessary calculations. The second period 12-month segment overlaps 8-months with the MIPS performance period which means that many of the patients in our complex patient bonus would have been cared for by the clinician, group, virtual group, or APM Entity during the MIPS performance period.
HCC risk scores for beneficiaries would be calculated based on the calendar year immediately prior to the performance period. For the 2018 MIPS performance period, the HCC risk scores would be calculated based on beneficiary services from the 2017 calendar year. We proposed this approach because CMS uses prior year diagnoses to set Medicare Advantage rates prospectively every year and has employed this approach in the VM (77 FR 69317 through 69318). Additionally, this approach mitigates the risk of “upcoding” to get higher expected costs, which could happen if concurrent risk adjustments were incorporated. We noted that we realized using the 2017 calendar year to assess beneficiary HCC risk scores overlaps by 4 months with the 12-month data period to identify beneficiaries (which is September 1, 2017 to August 31, 2018 for the 2018 MIPS performance period); however, we annually calculate the beneficiary HCC risk score and use it for multiple purposes (like the Physician and Other Supplier Public Use File).
For MIPS APMs and virtual groups, we proposed at § 414.1380(c)(3)(ii) to use the beneficiary weighted average HCC risk score for all MIPS eligible clinicians, and if technically feasible, TINs for models and virtual groups which rely on complete TIN participation, within the APM Entity or virtual group, respectively, as the complex patient bonus. We would calculate the weighted average by taking the sum of each individual clinician's (or TIN's as appropriate) average HCC risk score multiplied by the number of unique beneficiaries cared for by the clinician and then divide by the sum of the beneficiaries cared for by each individual clinician (or TIN as appropriate) in the APM Entity or virtual group.
We proposed at § 414.1380(c)(3)(iii) that the complex patient bonus cannot exceed 3 points. We divided clinicians and groups into quartiles based on average HCC risk score and percentage of patients who are dual eligible. A cap of 3 points was selected because the differences in performance we observed
We expressed our belief that applying this bonus to the final score is appropriate because caring for complex and vulnerable patients can affect all aspects of a practice and not just specific performance categories. It may also create a small incentive to provide access to complex patients. We considered whether we should apply a set number of points to those in a specific quartile (for example, for the highest risk quartile only), but did not want to restrict the bonus to only certain MIPS eligible clinicians. Rather than assign points based on quartile, we believed that adding the average HCC risk score directly to the final score would achieve our goal of accounting for patient complexity without masking low performance and does provide a modest effect on the final score.
Finally, we proposed that the MIPS eligible clinician, group, virtual group, or APM Entity must submit data on at least one measure or activity in a performance category during the performance period to receive the complex patient bonus. Under this proposal, MIPS eligible clinicians would not need to meet submission requirements for the quality performance category in order to receive the bonus (they could instead submit improvement activities or advancing care information measures only or submit fewer than the required number of measures for the quality performance category).
Based on our data analysis using our proposed scoring model with the cost performance category weighted at zero percent, we estimated that this bonus on average would range from 1.16 points in the first quartile of MIPS eligible clinicians when ranked by average HCC risk scores to 2.49 points in the fourth quartile for individual reporters submitting 6 or more measures, and 1.26 points in the first quartile to 2.23 points in the fourth quartile for group reporters. For example, a MIPS eligible clinician with a final score of 55.11 with an average HCC risk score of 2.01 would receive a final score of 57.12. We proposed (82 FR 30140) to modify the final score calculation formula so that if the result of the calculation is greater than 100 points, then the final score would be capped at 100 points.
We also sought comment on an alternative complex patient bonus methodology, similarly for the 2020 MIPS payment year only (82 FR 30139). Under the alternative, we would apply a complex patient bonus based on a ratio of patients who are dual eligible because dual eligible status is a common indicator of social risk for which we currently have data available. We expressed our belief that the advantage of this option is its relative simplicity and that it creates a direct incentive to care for dual eligible patients, who are often medically complex and have concurrent social risk factors. In addition, whereas the HCC risk scores rely on the diagnoses a beneficiary receives which could be impacted by variations in coding practices among clinicians, the dual eligibility ratio is not impacted by variations in coding practices. For this alternative option, we would calculate a dual eligible ratio (including both full and partial Medicaid beneficiaries) for each MIPS eligible clinician based on the proportion of unique patients who have dual eligible status seen by the MIPS eligible clinician among all unique patients seen during the second 12-month segment of the eligibility period, which spans 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. For MIPS APMs and virtual groups, we would use the average dual eligible patient ratio for all MIPS eligible clinicians, and if technically feasible, TINs for models and virtual groups which rely on complete TIN participation, within the APM Entity or virtual group, respectively.
Under this alternative option, we would identify dual eligible status (numerator of the ratio) using data on dual-eligibility status sourced from the state Medicare Modernization Act (MMA) files, which are files each state submits to CMS with monthly Medicaid eligibility information. We would use dual-eligibility status data from the state MMA files because it is the best available data for identifying dual eligible beneficiaries. Under this alternative option, we would include both full-benefit and partial benefit beneficiaries in the dual eligible ratio, and an individual would be counted as a dual patient if they were identified as a full-benefit or partial-benefit dual patient in the state MMA files at the conclusion of the second 12-month segment of the eligibility determination period.
We proposed to define the proportion of full-benefit or partial-benefit dual eligible beneficiaries as the proportion of dual eligible patients among all unique Medicare patients seen by the MIPS eligible clinician or group during the second 12-month segment of the eligibility period which spans from the last 4 months of a calendar year prior to the performance period followed by the first 8 months of the performance period in the next calendar year (September 1, 2017 to August 31, 2018 for the 2018 MIPS performance period), to identify MIPS eligible clinicians for calculation of the complex patient bonus. This date range aligns with the second low-volume threshold determination and also represents care provided during the performance period.
We proposed to multiply the dual eligible ratio by 5 points to calculate a complex patient bonus for each MIPS eligible clinician. For example, a MIPS eligible clinician who sees 400 patients with dual eligible status out of 1,000 total Medicare patients seen during the second 12-month segment of the eligibility period would have a complex patient ratio of 0.4, which would be multiplied by 5 points for a complex patient bonus of 2 points toward the final score. We believe this approach would be simple to explain and would be available to all clinicians who care for dual eligible beneficiaries. We also believed a complex patient bonus ranging from 1 to 5 points (with most MIPS eligible clinicians receiving a bonus between 1 and 3 points) would be appropriate because, in our analysis, we estimated differences in performance between the 1st and 4th quartiles of dual eligible ratios to be approximately 3 points for individuals and approximately 6 points for groups. A bonus of less than 5 points would help to mitigate the impact of caring for patients with social risk factors while not masking poor performance. Using this approach, we estimated that the bonus would range from 0.45 (first dual quartile) to 2.42 (fourth dual quartile) for individual reporters, and from 0.63 (first dual quartile) to 2.19 (fourth dual quartile) for group reporters. Under this alternative option, we would also include the complex patient bonus in the calculation of the final score. We proposed that if the result of the calculation is greater than 100 points, then the final score would be capped at 100 points (82 FR 30140). We sought comments on our proposed bonus for
The following is a summary of the public comments received on these proposals and our responses:
As discussed later in this section, a 5-point cap was requested by several commenters. While we did not want to mask poor performance, we believe raising the cap to 5 points could be supported by the data and would align with the small practice bonus. Using our proposed scoring model, we observed a decrease in simulated scores of approximately 4 points (for individuals who report 6 or more quality measures) and approximately 5 points (for groups) from the top quartile to the bottom quartile for the average patient HCC risk score. Our updated model showed similar distribution. We believe that the 3-point cap we proposed was justified in order to not mask poor performance, given the differences in quartiles scores, and we believe a cap of 5 points could also be supported. Using our updated scoring model (described in the regulatory impact analysis section VI.D of this final rule with comment period), we estimate a decrease in simulated scores of 5.4 points (for individuals who report 6 or more quality measures) and 4.5 points (for groups) from the top quartile to the bottom quartile for the average patient HCC risk scores and 4.8 points (for individuals who report 6 or more quality measures) and 4.5 points (for groups) from the top quartile to the bottom quartile for the dual eligible ratio. Therefore, we believe a cap for the complex patient bonus of 5 points is supported by this updated data with slightly higher differences in performance based on HCC risk scores and dual eligibility.
We do not believe that adopting a threshold is appropriate at this time because it would add additional complexity. In addition, a threshold would likely create an artificial “cliff,” where MIPS eligible clinicians just above the threshold would receive a bonus while those just below the threshold would not, even though the differences in patient populations between these two groups may be very minimal. We also believe that separate bonuses for complex patients (as opposed to a single combined score) may add unnecessary confusion to MIPS eligible clinicians.
Using our scoring model, we estimate that the average complex patient bonus will range from 2.52 in the first HCC quartile to 3.72 in the highest HCC quartile for all MIPS eligible clinicians. Table 27 includes the distribution for the complex patient bonus under our final policy, along with bonuses based on the proposed approach (based on HCC risk scores only) and the alternate approach (based on dual eligible ratio).
Eligible clinicians and groups who work in small practices are a crucial part of the health care system. The Quality Payment Program provides options designed to make it easier for these MIPS eligible clinicians and groups to report on performance and quality and participate in advanced alternative payment models for incentives. We have heard directly from clinicians in small practices that they face unique challenges related to financial and other resources, environmental factors, and access to health information technology. We heard from many commenters that the Quality Payment Program gives an advantage to large organizations because such organizations have more resources invested in the infrastructure required to track and report measures to MIPS. We also observed that, based on our scoring model, which is described in the regulatory impact analysis in the CY 2018 Quality Payment Program proposed rule (82 FR 30233 through 30241), practices with more than 100 clinicians may perform better in the Quality Payment Program, on average, compared to smaller practices. We believe this trend is due primarily to two factors: participation rates and submission mechanism. Based on the most recent PQRS data available, practices with 100 or more MIPS eligible clinicians have participated in the PQRS at a higher rate than small practices (99.4 percent compared to 69.7 percent, respectively). As we indicate in our regulatory impact analysis in the CY 2018 Quality Payment Program proposed rule (82 FR 30233 through 30241), we believe participation rates based only on historic 2015 quality data submitted under PQRS significantly underestimate the expected participation in MIPS particularly for small practices. Therefore, we have modeled the regulatory impact analysis using minimum participation assumptions of 80 percent and 90 percent participation for each practice size category (1-15 clinicians, 16-24 clinicians, 25-99 clinicians, and 100 or more clinicians). However, even with these enhanced participation assumptions, MIPS eligible clinicians in small practices would have lower participation in MIPS than MIPS eligible clinicians in larger practices have had in PQRS, as 80 or 90 percent participation is still much lower than the 99.4 percent PQRS participation for MIPS eligible clinicians in practices with 100 or more clinicians.
In addition, the most recent PQRS data (from CY 2016) indicates practices with 100 or more MIPS eligible clinicians are more likely to report as a group, rather than individually, which reduces burden to individuals within those practices due to the unified nature of group reporting. Specifically, 62.1 percent of practices with 100 or more MIPS eligible clinicians have reported via CMS Web Interface (either through the Shared Savings Program or as a group practice) compared to 22.4 percent of small practices (the CMS Web Interface reporting mechanism is only available to small practices participating in the Shared Savings Program or Next Generation ACO Model).
These two factors have financial implications based on the MIPS scoring model described in the CY 2018 Quality Payment Program proposed rule (82 FR 30233 through 30241). Looking at the combined impact performance, we observed consistent trends for small practices in various scenarios. A combined impact of performance measurement looks at the aggregate net percent change (the combined impact of MIPS negative and positive adjustments). The MIPS payment adjustment is connected to the final score because final scores below the performance threshold receive a negative MIPS payment adjustment and final scores above the performance threshold receive a positive MIPS payment adjustment. In analyzing the combined impact performance, we see MIPS eligible clinicians in small practices consistently have a lower combined impact performance than larger practices based on actual historical data and after we apply the 80 and 90 percent participation assumptions.
Due to these challenges, we proposed an adjustment to the final score for MIPS eligible clinicians in small practices (referred to herein as the “small practice bonus”) to recognize these barriers and to incentivize MIPS
We proposed at § 414.1380(c)(4) to add a small practice bonus of 5 points to the final score for MIPS eligible clinicians who participate in MIPS for the 2018 MIPS performance period and are in small practices, virtual groups, or APM Entities with 15 or fewer clinicians (the entire virtual group or APM Entity combined must include 15 or fewer clinicians to qualify for the bonus). We proposed in the CY 2018 Quality Payment Program proposed rule that if the result of the calculation is greater than 100 points, then the final score would be capped at 100 points (82 FR 30140). This bonus is intended to be a short-term strategy to help small practices transition to MIPS; therefore, we proposed the bonus only for the 2018 MIPS performance period (2020 MIPS payment year) and will assess on an annual basis whether to continue the bonus and how the bonus should be structured.
We invited public comment on our proposal to apply a small practice bonus for the 2020 MIPS payment year.
We also considered applying a bonus for MIPS eligible clinicians that practice in either a small practice or a rural area. However, on average, because we saw less than a 1-point difference between scores for MIPS eligible clinicians who practice in rural areas and those who do not, we did not propose a bonus for those who practice in a rural area, but plan to continue to monitor the Quality Payment Program's impacts on the performance of those who practice in rural areas. We also sought comment on the application of a rural bonus in the future, including available evidence demonstrating differences in clinician performance based on rural status. If we implement a bonus for practices located in rural areas, we would use the definition for rural specified in section II.C.1.d. of this final rule with comment period for individuals and groups (including virtual groups).
The following is a summary of the public comments received on these proposals and our responses:
We seek comment on approaches to better align final score and performance category level bonuses for simplicity in future rulemaking.
We proposed a formula for the final score calculation for MIPS eligible clinicians, groups, virtual groups, and APM Entities at § 414.1380(c), which includes the proposed complex patient and small practice bonuses. We also proposed to revise the policy finalized in the CY 2017 Quality Payment Program final rule to assign MIPS eligible clinicians with only 1 scored performance category a final score that is equal to the performance threshold (81 FR 77326 through 77328) (we noted that we inadvertently failed to codify this policy in § 414.1380(c)). We proposed this revision to the policy to account for our proposal in the CY 2018 Quality Payment Program proposed rule (82 FR 30144 through 30146) for extreme and uncontrollable circumstances which, if finalized, could result in a scenario where a MIPS eligible clinician is not scored on any performance categories. To reflect this proposal, we proposed to add to § 414.1380(c) that a MIPS eligible clinician with fewer than 2 performance category scores would receive a final score equal to the performance threshold.
With the proposed addition of the complex patient and small practice bonuses, we also proposed to strike the following phrase from the final score definition at § 414.1305: “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.” We believed this portion of the definition would be incorrect and redundant of the proposed revised regulation at § 414.1380(c).
We requested public comment on the proposed final score methodology and associated revisions to regulation text.
The following is a summary of the public comments received on these proposals and our responses:
In the meantime, we seek comment on approaches to display scores and provide feedback to MIPS eligible clinicians in a way that MIPS eligible clinicians can easily understand how their scores are calculated, including how performance category scores are translated to a final score. We also seek comment on how to simplify the scoring system while still recognizing differences in clinician practices.
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 the transition year, not more than 10 percent of the final score will be based on the cost performance category, and for the 2020 MIPS payment year, not more than 15 percent will be based on the 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.
In the CY 2017 Quality Payment Program final rule, we established the weights of the cost performance category as 10 percent of the final score (81 FR 77166) and the quality performance category as 50 percent of the final score (81 FR 77100) for the 2020 MIPS payment year. While we proposed in the CY 2018 Quality Payment Program proposed rule (82 FR 30047 through 30048) to change the weight of the cost performance category to zero percent and to change the weight of the quality performance category to 60 percent for the 2020 MIPS payment year, we are finalizing a weight of 10 percent for cost for the 2020 MIPS payment year, so the quality performance category weight will be 50 percent (82 FR 30037 through 30038). We refer readers to sections II.C.6.b. and II.C.6.d. of this final rule with comment period for further information on the final policies related to the weight of the quality and cost performance categories, including our rationale for our weighting for each category.
As specified in section 1848(q)(5)(E)(i) of the Act, the weights for the other performance categories are 25 percent for the advancing care information performance category and 15 percent for the improvement activities performance category. Section 1848(q)(5)(E)(ii) of the Act provides that in any year in which the Secretary estimates that the proportion of eligible professionals (as defined in section 1848(o)(5) of the Act) who are meaningful EHR users (as determined in 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 final score, but not below 15 percent. For more on our policies concerning section 1848(q)(5)(E)(ii) of the Act and a review of our proposal for reweighting the advancing care information performance category in the event that the proportion of MIPS eligible clinicians who are meaningful EHR users is 75 percent or greater starting with the 2019 MIPS performance period, we refer readers to section II.C.6.f.(5) of this final rule with comment period.
Table 28 summarizes the weights specified for each performance category.
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. For the 2020 MIPS payment year, we proposed to assign a scoring weight of zero percent to a performance category
For the quality performance category, we proposed that having sufficient measures applicable and available means that we can calculate a quality performance category percent score for the MIPS eligible clinician because at least one quality measure is applicable and available to the MIPS eligible clinician. Based on the volume of measures available to MIPS eligible clinicians via the multiple submission mechanisms, we stated that we generally believe there will be at least 1 quality measure applicable and available to every MIPS eligible clinician. If we receive no quality performance category submission from a MIPS eligible clinician, the MIPS eligible clinician generally will receive a performance category score of zero (or slightly above zero if the all-cause hospital readmission measure applies because the clinician submits data for a performance category other than the quality performance category).
The proposed quality performance category scoring policies for the 2020 MIPS payment year continue many of the special scoring policies from the transition year which would enable us to determine a quality performance category percent score whenever a MIPS eligible clinician has submitted at least 1 quality measure. In addition, MIPS eligible clinicians that do not submit quality measures when they have them available and applicable would receive a quality performance category percent score of zero percent. It is only in the rare scenarios when we determine that a MIPS eligible clinician does not have any relevant quality measures available to report or the MIPS eligible clinician is approved for reweighting the quality performance category based on extreme and uncontrollable circumstances as proposed in the CY 2018 Quality Payment Program proposed rule (82 FR 30142 through 30144), that we would reweight the quality performance category.
For the cost performance category, we stated that we continue to believe that having sufficient measures applicable and available means that we can reliably calculate a score for the cost measures that adequately captures and reflects the performance of a MIPS eligible clinician, and that MIPS eligible clinicians who are not attributed enough cases to be reliably measured should not be scored for the cost performance category (82 FR 30142). We established a policy in the CY 2017 Quality Payment Program final rule that if a MIPS eligible clinician is not attributed enough 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 (81 FR 77323). If we do not score any cost measures for a MIPS eligible clinician in accordance with this policy, then the clinician would not receive a cost performance category percent score. Because we proposed in the CY 2018 Quality Payment Program proposed rule to set the weight of the cost performance category to zero percent of the final score for the 2020 MIPS payment year, we did not propose to redistribute the weight of the cost performance category to any other performance categories for the 2020 MIPS payment year. In the event we did not finalize this proposal, we proposed to redistribute the weight of the cost performance category as described in the CY 2018 Quality Payment Program proposed rule (82 FR 30144 through 30146).
For the improvement activities performance category, we stated the belief that all MIPS eligible clinicians will have sufficient activities applicable and available; however, as discussed in the CY 2018 Quality Payment Program proposed rule (82 FR 30142 through 30144), we believe there are limited extreme and uncontrollable circumstances, such as natural disasters, where a clinician is unable to report improvement activities. Barring these circumstances, we did not propose any changes that would affect our ability to calculate an improvement activities performance category score.
We refer readers to the CY 2018 Quality Payment Program proposed rule (82 FR 30075 through 30079) for a detailed discussion of our proposals and policies under which we would not score the advancing care information performance category and would assign a weight of zero percent to that category for a MIPS eligible clinician.
We invited public comment on our interpretation of sufficient measures available and applicable in the performance categories.
In the CY 2017 Quality Payment Program final rule (81 FR 77241 through 77243), we discussed our belief that extreme and uncontrollable circumstances, such as a natural disaster in which an EHR or practice location is destroyed, can happen at any time and are outside a MIPS eligible clinician's control. We stated that if a MIPS eligible clinician's CEHRT is unavailable as a result of such circumstances, then the measures specified for the advancing care information performance category may not be available for the MIPS eligible clinician to report. We established a policy allowing a MIPS eligible clinician affected by extreme and uncontrollable circumstances to submit an application to us to be considered for reweighting of the advancing care information performance category under section 1848(q)(5)(F) of the Act. Although we proposed (82 FR 30075 through 30078) to use the authority in the last sentence of section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act, as the authority for this policy, rather than section 1848(q)(5)(F) of the Act, we continue to believe that extreme and uncontrollable circumstances could affect the availability of a MIPS eligible clinician's CEHRT and the measures specified for the advancing care information performance category.
While we had not adopted a similar reweighting policy for the other performance categories in the transition year, we stated that we believe a similar reweighting policy may be appropriate for the quality, cost, and improvement activities performance categories beginning with the 2020 MIPS payment year (82 FR 30142). For these performance categories, we proposed to define “extreme and uncontrollable circumstances” as rare (that is, highly
We stated that we believe that extreme and uncontrollable circumstances, such as natural disasters, may affect a clinician's ability to access or submit quality measures via all submission mechanisms (effectively rendering the measures unavailable to the clinician), as well as the availability of numerous improvement activities. In addition, damage to a facility where care is provided due to a natural disaster, such as a hurricane, could result in practice management and clinical systems that are used for the collection or submission of data to be down, thus impacting a clinician's ability to submit necessary information via Qualified Registry, QCDR, CMS Web Interface, or claims. This policy would not include issues that third-party intermediaries, such as EHRs, Qualified Registries, or QCDRs, might have submitting information to MIPS on behalf of a MIPS eligible clinician. Instead, this policy is geared towards events, such as natural disasters, that affect the MIPS eligible clinician's ability to submit data to the third-party intermediary, which in turn, could affect the ability of the clinician (or the third-party intermediary acting on their behalf) to successfully submit measures and activities to MIPS.
We also proposed to use this policy for measures which we derive from claims data, such as the all-cause hospital readmission measure and the cost measures. Other programs, such as the Hospital VBP Program, allow hospitals to submit exception applications when “a hospital is able to continue to report data on measures . . . but can demonstrate that its Hospital VBP Program measure rates are negatively impacted as a result of a natural disaster or other extraordinary circumstance and, as a result, the hospital receives a lower value-based incentive payment” (78 FR 50705). For the Hospital VBP Program, we “interpret[ed] the minimum numbers of cases and measures requirement in the Act to enable us to not score . . . all applicable quality measure data from a performance period and, thus, exclude the hospital from the Hospital VBP Program for a fiscal year during which the hospital has experienced a disaster or other extraordinary circumstance” (78 FR 50705). Hospitals that request and are granted an exception are exempted from the Program entirely for the applicable year.
For the 2020 MIPS payment year, we would score quality measures and assign points even for those clinicians who do not meet the case minimums for the quality measures they submit. However, we established a policy not to score a cost measure unless a MIPS eligible clinician has met the required case minimum for the measure (81 FR 77323), and not to score administrative claims measures, such as the all-cause hospital readmission measure, if they cannot be reliably scored against a benchmark (81 FR 77288 through 77289). Even if the required case minimums have been met and we are able to reliably calculate scores for the measures that are derived from claims, we believe a MIPS eligible clinician's performance on those measures could be adversely impacted by a natural disaster or other extraordinary circumstance, similar to the issues we identified for the Hospital VBP Program. For example, the claims data used to calculate the cost measures or the all-cause hospital readmission measure could be significantly affected if a natural disaster caused wide-spread injury or health problems for the community, which could not have been prevented by high-value healthcare. In such cases, we believe that the measures are available to the clinician, but are likely not applicable, because the extreme and uncontrollable circumstance has disrupted practice and measurement processes. Therefore, we believed an approach similar to that in the Hospital VBP Program (78 FR 50705) is warranted under MIPS, and we proposed that we would exempt a MIPS eligible clinician from all quality and cost measures calculated from administrative claims data if the clinician is granted an exception for the respective performance categories based on extreme and uncontrollable circumstances.
Beginning with the 2020 MIPS payment year, we proposed that we would reweight the quality, cost, and/or improvement activities performance categories if a MIPS eligible clinician, group, or virtual group's request for a reweighting assessment based on extreme and uncontrollable circumstances is granted. We proposed that MIPS eligible clinicians could request a reweighting assessment if they believe extreme and uncontrollable circumstances affect the availability and applicability of measures for the quality, cost, and improvement activities performance categories. To the extent possible, we noted we would seek to align the requirements for submitting a reweighting assessment for extreme and uncontrollable circumstances with the requirements for requesting a significant hardship exception for the advancing care information performance category. For example, we proposed to adopt the same deadline (December 31, 2018 for the 2018 MIPS performance period) for submission of a reweighting assessment (see 82 FR 30075 through 30078), and we encouraged the requests to be submitted on a rolling basis. We proposed the reweighting assessment must include the nature of the extreme and uncontrollable circumstance, including the type of event, date of the event, and length of time over which the event took place, performance categories impacted, and other pertinent details that impacted the ability to report on measures or activities to be considered for reweighting of the quality, cost, or improvement activities performance categories (for example, information detailing how exactly the event impacted availability and applicability of measures). We stated that if we finalize the policy to allow reweighting based on extreme and uncontrollable circumstances beginning with the 2020 MIPS payment year, we would specify the form and manner in which these reweighting applications must be
For virtual groups, we proposed to request that virtual groups submit a reweighting assessment for extreme and uncontrollable circumstances similar to groups, and we would evaluate whether sufficient measures and activities are applicable and available to the majority of TINs in the virtual group. We proposed that a majority of TINs in the virtual group would need to be impacted before we grant an exception. We still found it important to measure the performance of virtual group members unaffected by an extreme and uncontrollable circumstance even if some of the virtual group's TINs are affected.
We also sought comment on what additional factors we should consider for virtual groups. We proposed that the reweighting assessment due to extreme and uncontrollable circumstances for the quality, cost, and improvement activities would not be available to APM Entities in the APM scoring standard for the following reasons. First, all MIPS eligible clinicians scored under the APM scoring standard will automatically receive an improvement activities category score based on the terms of their participation in a MIPS APM and need not report anything for this performance category. Second, the cost performance category has no weight under the APM scoring standard. Finally, for the quality performance category, each MIPS APM has its own rules related to quality measures and we believe any decisions related to availability and applicability of measures should reside within the model. As noted in the CY 2018 Quality Payment Program proposed rule (82 FR 30087 through 30088), APM entities in MIPS APMs would be able to request reweighting of the advancing care information performance category.
We noted that if we finalize these proposals for reweighting the quality, cost, and improvement activities performance categories based on extreme and uncontrollable circumstances, then it would be possible that one or more of these performance categories would not be scored and would be weighted at zero percent of the final score for a MIPS eligible clinician. We proposed to assign a final score equal to the performance threshold if fewer than 2 performance categories are scored for a MIPS eligible clinician. This is consistent with our policy finalized in the CY 2017 Quality Payment Program final rule that because the final score is a composite score, 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 (81 FR 77326 through 77328).
We requested comment on our extreme and uncontrollable circumstances proposals. We also sought comment on the types of the extreme and uncontrollable circumstances we should consider for this policy given the general parameters we describe in this section.
The following is a summary of the public comments received on these proposals and our responses:
These policies for reweighting the quality, cost, and improvement activities performance categories based on extreme and uncontrollable circumstances will apply beginning with the 2018 MIPS performance period/2020 MIPS payment year. We recognize, however, that MIPS eligible clinicians have been affected by the recent hurricanes Harvey, Irma, and Maria, which affected large regions of the United States in August and September of 2017. We are adopting interim final policies for the 2017 performance period/2019 MIPS payment year for MIPS eligible clinicians who have been affected by these hurricanes and other natural disasters and refer readers to the interim final rule with comment period in section III.B.
In the CY 2017 Quality Payment Program final rule, we codified at § 414.1380(c)(2) that we will assign different scoring weights for the performance categories if we determine there are not sufficient measures and activities applicable and available to MIPS eligible clinicians (81 FR 77327). We also finalized a policy to assign MIPS eligible clinicians with only one scored performance category a final score that is equal to the performance threshold, which means the clinician would receive a MIPS payment adjustment factor of zero percent for the year (81 FR 77326 through 77328). We proposed in the CY 2018 Quality Payment Program proposed rule (82 FR 30140) to refine this policy such that a MIPS eligible clinician with fewer than 2 performance category scores would receive a final score equal to the performance threshold. This refinement is to account for the proposal in the CY 2018 Quality Payment Program proposed rule (82 FR 30142 through 30144) for extreme and uncontrollable circumstances, which could result in a scenario where a MIPS eligible clinician is not scored on any performance categories. We referred readers to the CY 2017 Quality Payment Program final rule for a description of our policies for redistributing the weights of the performance categories (81 FR 77325 through 77329). For the 2020 MIPS payment year, we proposed to redistribute the weights of the performance categories in a manner that is similar to the transition year. However, we also proposed new scoring policies to incorporate our proposals for extreme and uncontrollable circumstances.
In the CY 2018 Quality Payment Program proposed rule, (82 FR 30075 through 30078) we proposed to use the authority in the last sentence of section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act, as the authority for certain policies under which we would assign a scoring weight of zero percent for the advancing care information performance category, and to amend § 414.1380(c)(2) to reflect the proposals. We did not, however, propose substantive changes to the policy established in the CY 2017 Quality Payment Program final rule to redistribute the weight of the advancing care information performance category to the other performance categories for the transition year (81 FR 77325 through 77329).
For the 2020 MIPS payment year, if we assign a weight of zero percent for the advancing care information performance category for a MIPS eligible clinician, we proposed (82 FR 30144) to continue our policy from the transition year and redistribute the weight of the advancing care information performance category to the quality performance category (assuming the quality performance category does not qualify for reweighting). We believe redistributing the weight of the advancing care information performance category to the quality performance category (rather than redistributing to both the quality and improvement activities performance categories) is appropriate because MIPS eligible clinicians have more experience reporting quality measures through the PQRS program, and measurement in this performance category is more mature.
We noted in the CY 2018 Quality Payment Program proposed rule (82 FR 30144) that if we do not finalize our proposal to weight the cost performance category at zero percent (which means the weight of the cost performance category is greater than zero percent), then we would not redistribute the weight of any other performance categories to the cost performance category. We believed this would be consistent with our policy of introducing cost measurement in a deliberate fashion and recognition that clinicians are more familiar with other elements of MIPS. In the rare and unlikely scenario where a MIPS eligible clinician qualifies for reweighting of the quality performance category percent score (because there are not sufficient quality measures applicable and available to the clinician or the clinician is facing extreme and uncontrollable circumstances) and the MIPS eligible clinician is eligible to have the advancing care information performance category reweighted to zero and the MIPS eligible clinician has sufficient cost measures applicable and available to have a cost performance category percent score that is not reweighted, then we would redistribute the weight of the quality and advancing care information performance categories to the improvement activities performance category and would not redistribute the weight to the cost performance category. We also proposed that if we finalize the cost performance category weight at zero percent for the 2020 MIPS payment year, then we would set the final score at the performance threshold because the final score would be based on the improvement activities performance category which would not be a
For the 2020 MIPS payment year, we proposed to redistribute the weight of the cost performance category to the quality performance category if we did not finalize the proposal to set the cost performance category at a zero percent weight, and if a MIPS eligible clinician does not receive a cost performance category percent score because there are not sufficient cost measures applicable and available to the clinician or the clinician is facing extreme and uncontrollable circumstances. In the rare scenarios where a MIPS eligible clinician does not receive a quality performance category percent score because there are not sufficient quality measures applicable and available to the clinician or the clinician is facing extreme and uncontrollable circumstances, we proposed to redistribute the weight of the cost performance category equally to the remaining performance categories that are not reweighted.
In the rare 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 or the clinician is facing extreme and uncontrollable circumstances, we proposed for the 2020 MIPS payment year to continue our policy from the transition year and redistribute the 60 percent weight of the quality performance category so that the performance category weights are 50 percent for the advancing care information performance category and 50 percent for the improvement activities performance category (assuming these performance categories do not qualify for reweighting). While clinicians have more experience reporting advancing care information measures, we believe equal weighting to both the improvement activities and advancing care information performance categories is appropriate for simplicity. Additionally, in the absence of quality measures, we believe increasing the relative weight of the improvement activities performance category is appropriate because both the improvement activities and advancing care information performance categories have elements of quality and care improvement which are important to emphasize. Should the cost performance category have available and applicable measures and the cost performance category weight is not zero, but either the improvement activities or advancing care information performance category is reweighted to zero percent, then we proposed that we would redistribute the weight of the quality performance category to the remaining performance category that is not weighted at zero percent. We would not redistribute the weight to the cost performance category.
We believe that all MIPS eligible clinicians will have sufficient improvement activities applicable and available. It is possible that a MIPS eligible clinician might face extreme and uncontrollable circumstances that render the improvement activities not applicable or available to the clinician; however, in that scenario, we believe it is likely that the measures specified for the other performance categories also would not be applicable or available to the clinician based on the circumstances. In the rare event that the improvement activities performance category would qualify for reweighting based on extreme and uncontrollable circumstances, and the other performance categories would not also qualify for reweighting, we proposed to redistribute the improvement activities performance category weight to the quality performance category consistent with the redistribution policies for the cost and advancing care information performance categories. We noted in the CY 2018 Quality Payment Program proposed rule (82 FR 30145) that, should the cost performance category have available and applicable measures and the cost performance category weight is not finalized at zero percent, and the quality performance category is reweighted to zero percent, then we would redistribute the weight of the improvement activities performance category to the advancing care information performance category. Table 38 in the CY 2018 Quality Payment Program proposed rule summarized the potential reweighting scenarios based on our proposals for the 2020 MIPS payment year should the cost performance category be weighted at zero percent (82 FR 30145).
We also considered an alternative approach for the 2020 MIPS payment year to redistribute the weight of the advancing care information performance category to the quality and improvement activities performance categories, to minimize the impact of the quality performance category on the final score. For this approach, we proposed to redistribute 15 percent to the quality performance category (60 percent + 15 percent = 75 percent) and 10 percent to the improvement activities performance category (15 percent + 10 percent = 25 percent). We considered redistributing the weight of the advancing care information performance category equally to the quality and improvement activities performance categories. However, for simplicity, we wanted to redistribute the weights in increments of 5 points. Because MIPS eligible clinicians have more experience reporting quality measures and because these measures are more mature, under this alternative option, we would redistribute slightly more to the quality performance category (15 percent vs. 10 percent). Should the cost performance category have available and applicable measures and the cost performance category weight is not finalized at zero percent and the quality performance category is reweighted to zero percent, then we would redistribute the weight of the advancing care information performance category to the improvement activities performance category. This alternative approach, which assumed a cost performance category weight of zero percent was detailed in Table 39 of the CY 2018 Quality Payment Program proposed rule (82 FR 30146).
We invited comments on our proposal for reweighting the performance categories for the 2020 MIPS payment year and our alternative option for reweighting the advancing care information performance category.
The following is a summary of the public comments received and our responses:
For purposes of applying the MIPS payment adjustment under section 1848(q)(6)(E) of the Act, we finalized a policy in the CY 2017 Quality Payment Program final rule 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 (81 FR 77329 through 77330). 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 did not propose any changes to the MIPS payment adjustment identifier.
In CY 2017 Quality Payment Program final rule (81 FR 77330 through 77332), we finalized a policy to use a TIN/NPI's performance from the performance period associated with the MIPS payment adjustment. We also proposed the following policies, and, although we received public comments on them and responded to those comments, we inadvertently failed to state that we were finalizing these policies, although it was our intention to do so. Thus, we clarify that the following final policies apply beginning with the transition year. For groups submitting data using the TIN identifier, we will 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 will
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. In cases where there is no final score associated with a TIN/NPI from the performance period, we will 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 will use that final score. 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 finalized a policy of taking the highest final score associated with that NPI in the performance period (81 FR 77332).
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, the following hierarchy will apply. 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. If a MIPS eligible clinician has more than one APM Entity final score, we will apply the highest APM Entity final score to the MIPS eligible clinician. If a MIPS eligible clinician reports as a group and as an individual and not as an APM Entity, we will calculate a final score for the group and individual identifier and use the highest final score for the TIN/NPI (81 FR 77332).
For a further description of our policies, we referred readers to the CY 2017 Quality Payment Program final rule (81 FR 77330 through 77332).
In addition to the above policies from the CY 2017 Quality Payment Program final rule, beginning with the 2020 MIPS payment year, we proposed to modify the policies to address the addition of virtual groups. Section 1848(q)(5)(I)(i) of the Act provides that MIPS eligible clinicians electing to be a virtual group must: (1) Have their performance assessed for the quality and cost performance categories in a manner that applies the combined performance of all the MIPS eligible clinicians in the virtual group to each MIPS eligible clinician in the virtual group for the applicable performance period; and (2) be scored for the quality and cost performance categories based on such assessment. Therefore, when identifying a final score for payment adjustments, we must prioritize a virtual group final score over other final scores such as individual and group scores. Because we also wish to encourage movement towards APMs, we will prioritize using the APM Entity final score over any other score for a TIN/NPI, including a TIN/NPI that is in a virtual group. If a TIN/NPI is in both a virtual group and a MIPS APM, we proposed to use the waiver authority for Innovation Center models under section 1115A(d)(1) of the Act and the Shared Savings Program waiver authority under section 1899(f) of the Act to waive section 1848(q)(5)(I)(i)(I) and (II) of the Act so that we could use the APM Entity final score instead of the virtual group final score for a TIN/NPI. As discussed in the CY 2018 Quality Payment Program proposed rule (82 FR 30033 through 30034), the use of waiver authority is to avoid creating competing incentives between MIPS and the APM. We want MIPS eligible clinicians to focus on the requirements of the APM to ensure that the models produce valid results that are not confounded by the incentives created by MIPS.
We also proposed to modify our hierarchy to state that if a MIPS eligible clinician is not in an APM Entity and is in a virtual group, the MIPS eligible clinician would receive the virtual group final score over any other final score. Our policies remain unchanged for TIN/NPIs who are not in an APM Entity or virtual group. Tables 40 and 41 in the CY 2018 Quality Payment Program proposed rule summarized the final and proposed policies (82 FR 30147).
We will only apply the associated final score to clinicians or groups who are not otherwise excluded from MIPS. We invited public comment on our proposals.
The following is a summary of the public comments received and our responses:
Tables 30 and 31 illustrate the final policies for determining which final score will be used when more than one final score is associated with a TIN/NPI (Table 30) and the final policies that apply if there is no final score
For a description of the statutory background and further description of our policies, we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77332 through 77333).
Although we did not propose any changes to these policies, nor did we request public comments, we did receive comments on this topic, which we will consider in preparation for future rulemaking.
Under section 1848(q)(6)(D)(i) of the Act, for each year of the MIPS, the Secretary shall compute a performance threshold with respect to 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 period 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 codified 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. We codified at § 414.1405(b) that a performance threshold will be specified for each MIPS payment year. We referred readers to the CY 2017 Quality Payment Program final rule for further discussion of the performance threshold (81 FR 77333 through 77338). In accordance with the special rule set forth in section 1848(q)(6)(D)(iii) of the Act, we finalized a performance threshold of 3 points for the transition year (81 FR 77334 through 77338). We inadvertently failed to codify the performance threshold for the 2019 MIPS payment year in the CY 2017 Quality Payment Program final rule, although it was our intention to do so. Thus, we now codify the performance threshold of 3 points for the 2019 MIPS payment year at § 414.1405(b)(4).
Our goal was to encourage participation and provide an opportunity for MIPS eligible clinicians to become familiar with the MIPS program. We determined that it would have been inappropriate to set a performance threshold that would result in downward adjustments to payments for many clinicians who may not have had time to prepare adequately to succeed under MIPS. By providing a pathway for many clinicians to succeed under MIPS, we believed that we would encourage early participation in the program, which may enable more robust and thorough engagement with the program over time. We set the performance threshold at a low number to provide MIPS eligible clinicians an opportunity to achieve a minimum level of success under the program, while gaining experience with reporting on the measures and activities and becoming familiar with other program
For the 2020 MIPS payment year, we again wanted to use the flexibility provided in section 1848(q)(6)(D)(iii) to help transition MIPS eligible clinicians to the 2021 MIPS payment year, when the performance threshold will be the mean or median of the final scores for all MIPS eligible clinicians from a prior period. We wanted to encourage continued participation and the collection of meaningful data by MIPS eligible clinicians. A higher performance threshold would help MIPS eligible clinicians strive to achieve more complete reporting and better performance and prepare MIPS eligible clinicians for the 2021 MIPS payment year. However, a performance threshold set too high could also create a performance barrier, particularly for MIPS eligible clinicians who did not previously participate in PQRS or the EHR Incentive Programs. We have heard from stakeholders requesting that we continue a low performance threshold and from stakeholders requesting that we ramp up the performance threshold to help MIPS eligible clinicians prepare for the 2021 MIPS payment year and to meaningfully incentivize higher performance. Given our desire to provide a meaningful ramp between the transition year's 3-point performance threshold and the 2021 MIPS payment year performance threshold using the mean or median of the final scores for all MIPS eligible clinicians for a prior period, we proposed to set the performance threshold at 15 points for the 2020 MIPS payment year (82 FR 30147 through 30149).
We proposed a performance threshold of 15 points because it represents a meaningful increase, compared to 3 points in the transition year, while maintaining flexibility for MIPS eligible clinicians in the pathways available to achieve this performance threshold. We refer readers to the CY 2018 Quality Payment Program proposed rule (82 FR 30148) for examples of how clinicians could meet or exceed a performance threshold of 15 points based on our proposed policies.
We believed the proposed performance threshold would mitigate concerns from MIPS eligible clinicians about participating in the program for the second year. However, we remained concerned that moving from a performance threshold of 15 points for the 2020 MIPS payment year to a performance threshold of the mean or median of the final scores for all MIPS eligible clinicians for a prior period for the 2021 MIPS payment year may be a steep jump.
By the 2021 MIPS payment year, MIPS eligible clinicians would likely need to submit most of the required information and perform well on the measures and activities to receive a positive MIPS payment adjustment. Therefore, we also sought comment on setting the performance threshold either lower or higher than the proposed 15 points for the 2020 MIPS payment year. A performance threshold lower than the proposed 15 points for the 2020 MIPS payment year presents the potential for a significant increase in the final score a MIPS eligible clinician must earn to meet the performance threshold in the 2021 MIPS payment year, as well as providing for a potentially smaller total amount of negative MIPS payment adjustments upon which the total amount of the positive MIPS payment adjustments would depend due to the budget neutrality requirement under section 1848(q)(6)(F)(ii) of the Act. A performance threshold higher than the proposed 15 points would increase the final score required to receive a neutral MIPS payment adjustment, which may be particularly challenging for small practices, even with the proposed addition of the small practice bonus. A higher performance threshold would also allow for potentially higher positive MIPS payment adjustments for those who exceed the performance threshold.
We considered an alternative of setting a performance threshold of 6 points, which could be met by submitting 2 quality measures with required data completeness or one high-weighted improvement activity. While this lower performance threshold may provide a sharp increase to the required performance threshold in the 2021 MIPS payment year (the mean or median of the final scores for all MIPS eligible clinicians for a prior period), it would continue to reward clinicians for participation in MIPS as they transition into the program.
We also considered an alternative of setting the performance threshold at 33 points, which would require full participation both in improvement activities and in the quality performance category (either for a small group or for a large group that meets data completeness standards) to meet the performance threshold. Such a threshold would make the step to the required mean or median performance threshold in the 2021 MIPS payment year less steep but could present further challenges to clinicians who have not previously participated in legacy quality reporting programs.
As required by section 1848(q)(6)(D)(iii) of the Act, for the purposes of determining the performance threshold, we considered data available for performance on measures and activities that may be used under the MIPS performance categories. We refer readers to the CY 2018 Quality Payment Program proposed rule (82 FR 30147 through 30149) for a discussion of the data we considered.
We invited public comments on the proposal to set the performance threshold at 15 points, and also sought comment on setting the performance threshold at the alternative of 6 points or at 33 points for the 2020 MIPS payment year. We also sought public comments on principles and considerations for setting the performance threshold beginning with the 2021 MIPS payment year, which will be the mean or median of the final scores for all MIPS eligible clinicians from a prior period.
The following is a summary of the public comments received on our proposals for the performance threshold and our responses:
One commenter supported a performance threshold of 33 points because it would require participation in both the improvement activities and quality performance categories to avoid a negative adjustment. One commenter supported a 33-point performance threshold because the combined effect of the proposed changes for 2018, including the performance threshold, the low-volume threshold, small practice bonus, and EHR certification requirements, would reduce the opportunity for high-performing MIPS eligible clinicians to earn a reasonable increase to their Medicare payments in the 2020 MIPS payment year. One commenter recommended for those practices where a 33-point performance threshold may present a challenge because they have not participated in the legacy Medicare programs, CMS can assist them through the existing Transforming Clinical Practice Initiative (TCPI) that would help clinicians identify and report quality measures under the MIPS quality performance category.
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
We codified 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 also codified at § 414.1405(d) that an additional performance threshold will be specified for each of the MIPS payment years 2019 through 2024. We referred readers to the CY 2017 Quality Payment Program final rule for further discussion of the additional performance threshold (81 FR 77338 through 77339). We inadvertently failed to codify the additional performance threshold for the 2019 MIPS payment year in the CY 2017 Quality Payment Program final rule, although it was our intention to do so. Thus, we now codify the additional performance threshold for the 2019 MIPS payment year at § 414.1405(d)(3).
Based on the special rule for the initial 2 years of MIPS in section 1848(q)(6)(D)(iii) of the Act, for the transition year, we decoupled the additional performance threshold from the performance threshold and established the additional performance threshold at 70 points. We selected a 70-point numerical value for the additional performance threshold, in part, because it would require a MIPS eligible clinician to submit data for and perform well on more than one performance category (except in the event the advancing care information performance category is reweighted to zero percent and the weight is redistributed to the quality performance category making the quality performance category worth 85 percent of the final score). Under section 1848(q)(6)(C) of the Act, a MIPS eligible clinician with a final score at or above the additional performance threshold will receive an additional MIPS payment adjustment factor and may share in the $500,000,000 of funding available for the year under section 1848(q)(6)(F)(iv) of the Act. We believed these additional incentives should only be available to those clinicians with very high performance on the MIPS measures and activities. We took into account the data available and the modeling described in section II.E.7.c.(1) of the CY 2017 Quality Payment Program final rule in selecting the additional performance threshold for the transition year (81 FR 77338 through 77339).
As we discussed in the CY 2018 Quality Payment Program proposed rule (82 FR 30147 through 30149), we relied on the special rule under section 1848(q)(6)(D)(iii) of the Act to establish the performance threshold at 15 points for 2020 MIPS payment year. We proposed to again decouple the additional performance threshold from the performance threshold. Because we do not have actual MIPS final scores for a prior performance period, if we do not decouple the additional performance threshold from the performance threshold, then we would have to set the additional performance threshold at the 25th percentile of possible final scores above the performance threshold. With a performance threshold set at 15 points, the range of total possible points above the performance threshold is 16 to 100 points. The 25th percentile of that range is 36.25 points, which is barely more than one third of the possible 100 points in the MIPS final score. We do not believe it would be appropriate to lower the additional performance threshold to 36.25 points, as we do not believe a final score of 36.25 points demonstrates exceptional performance by a MIPS eligible clinician. We believe these additional incentives should only be available to those clinicians with very high performance on the MIPS measures and activities. Therefore, we relied on the special rule under section 1848(q)(6)(D)(iii) of the Act to propose the additional performance threshold at 70 points for the 2020 MIPS payment year, which is higher than the 25th percentile of the range of the possible final scores above the performance threshold.
We took into account the data available and the modeling described in the CY 2018 Quality Payment Program proposed rule (82 FR 30147 through 30148) to estimate final scores for the 2020 MIPS payment year. We believed 70 points is appropriate because it requires a MIPS eligible clinician to submit data for and perform well on more than one performance category (except in the event the advancing care information measures are not applicable and available to a MIPS eligible clinician). Generally, under our proposals, a MIPS eligible clinician could receive a maximum score of 60 points for the quality performance category, which is below the 70-point additional performance threshold. In addition, 70 points is at a high enough level that MIPS eligible clinicians must submit data for the quality performance category to achieve this target. For example, if a MIPS eligible clinician gets a perfect score for the improvement activities and advancing care information performance categories, but does not submit quality measures data, then the MIPS eligible clinician would only receive 40 points (0 points for quality + 15 points for improvement activities + 25 points for advancing care information), which is below the additional performance threshold. We believed an additional performance threshold of 70 points would maintain the incentive for excellent performance while keeping the focus on quality performance. Finally, we noted that we believed keeping the additional performance threshold at 70 points maintains consistency with the 2019 MIPS payment year which helps to simplify the overall MIPS framework.
We invited public comment on the proposals. We also sought feedback on whether we should raise the additional performance threshold to a higher number which would in many instances require the use of an EHR for those to whom the advancing care information performance category requirements would apply. In addition, a higher additional performance threshold would incentivize better performance and would also allow MIPS eligible clinicians to receive a higher additional MIPS payment adjustment.
We also sought public comment on which method we should use to compute the additional performance threshold beginning with the 2021 MIPS payment year. Section 1848(q)(6)(D)(ii) of the Act requires the additional performance threshold to be the score that is equal to the 25th percentile of the range of possible final scores above the performance threshold for the year, or the score that is equal to the 25th percentile of the actual final scores for MIPS eligible clinicians with final scores at or above the performance threshold for the prior period described in section 1848(q)(6)(D)(i) of the Act.
The following is a summary of the public comments received and our responses:
A few commenters supported raising the additional performance threshold for the 2018 MIPS performance period/2020 MIPS payment year to 75 points because this would allow for a potentially larger additional MIPS payment adjustment for qualifying clinicians compared to an additional performance threshold of 70 points. The increase would allow those MIPS eligible clinicians who expended significant effort and resources to perform at higher levels and earn a higher incentive for their achievement; would account for improvements in technology and processes; would align with a proposed increase in the performance threshold; and would better prepare the MIPS eligible clinician community for the statutory requirements for the 2021 MIPS payment year additional performance threshold.
One commenter supported an additional performance threshold of 80 points because it would be possible for a MIPS eligible clinician to exceed 70 points without reporting on the advancing care information measures.
We codified 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. We referred readers to the CY 2017 Quality Payment Program final rule for further discussion of budget neutrality (81 FR 77339).
We did not propose any changes to the scaling and budget neutrality requirements as they are applied to MIPS payment adjustment factors in this proposed rule.
We referred readers to the CY 2017 Quality Payment Program final rule for further discussion of the additional MIPS payment adjustment factor (81 FR 77339 through 77340). We did not propose any changes to determine the additional MIPS payment adjustment factors.
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 codified at § 414.1405(e) the application of the MIPS payment adjustment factors. 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.
We proposed to apply the MIPS payment adjustment factor, and if applicable, the additional MIPS payment adjustment factor, to the Medicare paid amount for items and services paid under Part B and furnished by the MIPS eligible clinician during the year. This proposal is consistent with the approach taken for the value-based payment modifier (77 FR 69308 through 69310) and would mean that beneficiary cost-sharing and coinsurance amounts would not be affected by the application of the MIPS payment adjustment factor and the additional MIPS payment adjustment factor. The MIPS payment adjustment applies only to the amount otherwise paid under Part B for items and services furnished by a MIPS eligible clinician during a year. Please refer to the CY 2017 Quality Payment Program final rule at 81 FR 77340 and the CY 2018 Quality Payment Program proposed rule at 82 FR 30019 and section II.C.1.a. of this final rule with comment period for further discussion and our proposals regarding which Part B covered items and services would be subject to the MIPS payment adjustment.
The following is a summary of the public comments received on these proposals and our responses:
In the CY 2018 Quality Payment Program proposed rule (82 FR 30152) we provided a figure and several tables as illustrative examples of how various final scores would be converted to an adjustment factor, and potentially an additional adjustment factor, using the statutory formula and based on proposed policies. We repeat these examples using our final policies. In Figure A, the performance threshold is 15 points. The applicable percentage is 5 percent for 2020. The adjustment factor is determined on a linear sliding scale from zero to 100, with zero being the lowest negative applicable percentage (negative 5 percent for the 2020 MIPS payment year), 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 zero and one-fourth of the performance threshold (zero and 3.75 points based on the performance threshold of 15 points for the 2020 MIPS payment year). All MIPS eligible clinicians with a final score in this range would receive the lowest negative applicable percentage (negative 5 percent for the 2020 MIPS payment year). Second, the linear sliding scale line for the positive MIPS adjustment factor is adjusted by the scaling factor, which cannot be higher than 3.0 (as discussed in section II.C.8.e. of this final rule with comment and in the CY 2018 Quality Payment Program proposed rule at 82 FR 30150). If the scaling factor is greater than zero and less than or equal to 1.0, then the adjustment factor for a final score of 100 would be less than or equal to 5 percent. If the scaling factor is above 1.0, but less than or equal to 3.0, then the adjustment factor for a final score of 100 would be higher than 5 percent. Only those MIPS eligible clinicians with a final score equal to 15 points (which is the performance threshold in this example) would receive a neutral MIPS payment adjustment. Because the performance threshold is 15 points, we anticipate that the scaling factor would be less than 1.0 and the payment adjustment for MIPS eligible clinicians with a final score of 100 points would be less than 5 percent.
Figure A illustrates an example of the slope of the line for the linear adjustments. In this example, the scaling factor for the adjustment factor is 0.06 which is much lower than 1.0. In this example, MIPS eligible clinicians with a final score equal to 100 would have an adjustment factor of 0.31 percent (5 percent × 0.06).
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. This linear sliding scale line is also multiplied by a scaling factor that is greater than zero and less than or equal to 1.0. The scaling factor will be determined so that the estimated aggregate increase in payments associated with the application of the additional adjustment factors is equal to $500,000,000. In Figure A, the example scaling factor for the additional adjustment factor is 0.175. Therefore, MIPS eligible clinicians with a final score of 100 would have an additional adjustment factor of 1.75 percent (10 percent × 0.175). The total adjustment for a MIPS eligible clinician with a final score equal to 100 would be 1 + 0.0031 + 0.0175 = 1.0205, for a total positive MIPS payment adjustment of 2.05 percent.
The final MIPS payment adjustments will 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 would receive positive MIPS payment adjustments.
Table 32 illustrates the changes in payment adjustments from the transition year to the 2020 MIPS payment year based on the final policies, as well as the statutorily-required increase in the applicable percent as required by section 1848(q)(6)(B) of the Act.
In the CY 2018 Quality Payment Program proposed rule, we provided a few examples for the 2020 MIPS payment year to demonstrate scenarios in which MIPS eligible clinicians can achieve a final score at or above the performance threshold of 15 points. We note a calculation error was included in Example 3. Because the MIPS eligible clinician did not submit advancing care information, the quality performance category should have been 85 percent to reflect reweighting, while the advancing care information performance category should have been zero percent. Earned points (column D) should have been 42.5 for quality to reflect reweighting and the final score should have been listed as 51.5.
We have provided updated examples below for the 2020 MIPS payment year to demonstrate scenarios in which MIPS eligible clinicians can achieve a final score at or above the performance threshold of 15 points based on our final policies.
In the example illustrated in Table 32, a MIPS eligible clinician in a small practice reporting individually meets the performance threshold by reporting one quality measure one time via claims and one medium-weight improvement activity. The practice does not submit data for the advancing care information performance category, but does submit a significant hardship exception application which is approved; therefore, the weight for the advancing care information performance category is reweighted to the quality performance category due to final reweighting policies discussed in section II.C.7.b.(3) of this final rule with comment period (82 FR 30141 through 30146). We also assumed the small practice has a cost performance category percent score of 50 percent. Finally, we assumed a complex patient bonus of 3 points which represents the average HCC risk score for the beneficiaries seen by the MIPS eligible clinician as well as the proportion of Medicare beneficiaries that are dual eligible. There are several special scoring rules which affect MIPS eligible clinicians in a small practice:
• 3 Measure achievement points for each quality measure even if the measure does not meet data completeness standards. We refer readers to section II.C.7.a.(2)(d) of this final rule with comment period for discussion of this policy. Therefore, a quality measure submitted one time would receive 3 points. Because the measure is submitted via claims, it does not qualify for the end-to-end electronic reporting bonus, nor would it qualify for the high-priority bonus because it is the only measure submitted. Because the MIPS eligible clinician does not meet full participation requirements, the MIPS eligible clinician does not qualify for improvement scoring. We refer readers to section II.C.7.a.(2)(i)(iii) of this final rule with comment period for a discussion on full participation requirements. Therefore, the quality performance category is (3 measure achievement points + zero measure bonus points)/60 total available measure points + zero improvement percent score which is 5 percent.
• The advancing care information performance category weight is redistributed to the quality performance category so that the quality performance category score is worth 75 percent of the final score. We refer readers to section II.C.7.b.(3)(d) of this final rule with comment period for a discussion of this policy.
• MIPS eligible clinicians in small practices qualify for special scoring for improvement activities so a medium weighted activity is worth 20 points out of a total 40 possible points for the improvement activities performance category. We refer readers to section II.C.6.e.(5) of this final rule with comment period for a discussion of this policy.
• MIPS eligible clinicians in small practices qualify for the 5-point small practice bonus which is applied to the
This MIPS eligible clinician exceeds the performance threshold of 15 points (but does not exceed the additional performance threshold). This score is summarized in Table 33.
In the example illustrated in Table 34, a MIPS eligible clinician in a medium size practice participating in MIPS as a group receives performance category scores of 75 percent for the quality performance category, 50 percent for the cost performance category, and 100 percent for the advancing care information and improvement activities performance categories. There are many paths for a practice to receive a 75 percent score in the quality performance category, so for simplicity we are assuming the score has been calculated at this amount. The final score is calculated to be 85.5, and both the performance threshold of 15 and the additional performance threshold of 70 are exceeded. Again, for simplicity, we assume a complex patient bonus of 3 points. In this example, the group practice does not qualify for any special scoring, yet is able to exceed the additional performance threshold and will receive the additional MIPS payment adjustment.
In the example illustrated in Table 35, an individual MIPS eligible clinician that is non-patient facing and not in a small practice receives performance category scores of 50 percent for the quality performance category, 50 percent for the cost performance category, and 50 percent for 1 medium-weighted improvement activity. Again, there are many paths for a practice to receive a 50 percent score in the quality performance category, so for simplicity we are assuming the score has been calculated. Because the MIPS eligible clinician is non-patient facing, they qualify for special scoring for improvement activities and receive 20 points (out of 40 possible points) for the medium weighted activity. Also, this individual did not submit advancing care information measures and qualifies for the automatic reweighting of the advancing care information performance category to the quality performance category. Again, for simplicity, we assume a complex patient bonus of 3 points. The MIPS eligible clinician is not in a small practice so does not qualify for the small practice bonus.
In this example, the final score is 53 and the performance threshold of 15 is exceeded while the additional performance threshold of 70 is not.
We note that these examples are not intended to be exhaustive of the types of participants nor the opportunities for reaching and exceeding the performance threshold.
As we have stated previously in the CY 2017 Quality Payment Program final rule (81 FR 77345), 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. Any suggestions from user research would be considered as we develop the systems needed for performance feedback, which would occur outside of the rulemaking process.
Over the past year, we have conducted numerous user research sessions to determine what the community most needs in performance feedback. In summary, we have found the users want the following:
(1) To know as soon as possible how I am performing based on my submitted data so that I have confidence that I performed the way I thought I would.
(2) To be able to quickly understand how and why my payments will be adjusted so that I can understand how my business will be impacted.
(3) To be able to quickly understand how I can improve my performance so that I can increase my payment in future program years.
(4) To know how I am performing over time so I can improve the care I am providing patients in my practice.
(5) To know how my performance compares to my peers.
Based on that research, we have already begun development of real-time feedback on data submission and scoring where technically feasible (some scoring requires all clinician data be submitted, and therefore, cannot occur until the end of the submission period). By “real-time” feedback, we mean instantaneous receipt recognition; for example, when a clinician submits their data via our Web site or a third party submits data via our Application Program Interface (API), they will know immediately if their submission was successful.
We will continue to provide information for stakeholders who wish to participate in user research via our education and communication channels. Suggestions can also be sent via the “Contact Us” information on
Under section 1848(q)(12)(A)(i) of the Act, 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.
We proposed to provide, beginning July 1, 2018, performance feedback to MIPS eligible clinicians and groups for the quality and cost performance categories for the 2017 performance period, and if technically feasible, for the improvement activities and advancing care information performance categories. We proposed to provide this performance feedback at least annually, and as, technically feasible, we would provide it more frequently, such as quarterly. If we are able to provide it more frequently, we would communicate the expected frequency to our stakeholders via our education and outreach communication channels.
Based on public comments summarized and responded to in the CY 2017 Quality Payment Program final rule (81 FR 77347), we also proposed that the measures and activities specified for the CY 2017 performance period (for all four MIPS performance categories), along with the final score, would be included in the performance feedback provided on or about July 1, 2018.
For cost measures, since we can measure performance using any 12-month period of prior claims data, we requested comment on whether it would be helpful to provide more frequent feedback on the cost performance category using rolling 12-month periods or quarterly snapshots of the most recent 12-month period; how frequent that feedback should be; and the format in which we should make it available to clinicians and groups. In addition, as described in sections II.C.6.b. and II.C.6.d. of the proposed rule, we stated in the proposed rule our intent to provide cost performance feedback in the fall of 2017 and the summer of 2018 on new episode-based cost measures that are currently under development by CMS. With regard to the format of feedback on cost measures, we noted how we are considering utilizing the parts of the Quality and Resource Use Reports (QRURs) that user testing has revealed beneficial while making the overall look and feel usable to clinicians. We requested comment on whether that format is appropriate or if other formats or revisions to that format should be used to provide performance feedback on cost measures.
The following is a summary of the public comments received on the “MIPS Eligible Clinicians” proposals and our responses:
One commenter noted that it is important that CMS reduce the amount of time between the performance period and performance feedback from CMS to allow practices time to make necessary adjustments before the next reporting period begins. The commenter also requested that feedback to clinicians should be delivered by CMS to clinicians beginning no later than April 1, 2019. A few commenters requested technology and system upgrades, so that CMS could improve the way performance information is disseminated to physicians and practices, such as dashboards or reports on demand. One commenter requested quarterly information to ensure the accuracy of the information, especially as CMS has proposed posting MIPS performance scores on the Physician Compare Web site.
Another commenter encouraged CMS to release the reports as early as possible, at minimum following the MACRA recommendation that data be available on a quarterly basis, so that clinicians are not well into the next reporting cycle before they learn of their MIPS results and performance and can institute workflow changes to ensure success under MIPS. One commenter expressed that measure-based feedback is helpful as eligible clinicians determine performance improvement plans and select measures for future performance periods. One commenter believes that patient-level data is helpful to eligible clinicians as they determine areas in which additional resources can be allocated.
Another commenter expressed concerns that there is limited experience in episode grouper and urged CMS to test and evaluate its episode grouper methodology and ensure that their application will not result in unintended consequences, such as stinting on needed care as a way to ensure that costs within the defined episode are contained. Another commenter noted that issues such as identifying the correct length of the episode window and assigning services to the episode (like rehabilitation therapy or imaging, etc.) each take hours to resolve and asked that CMS think critically about the MIPS timeline needed to build out every episode of care in the Medicare population. That commenter further requested that CMS provide stakeholders with a time-table for developing Medicare Cost measure episodes as well as a list of future episodes under consideration and that once developed, the proposed details of the new episode-based cost measures should be subject to notice and comment rulemaking in a future proposed rule. Finally, the commenter noted that while this performance category relies solely on administrative claims data, critical resource use related questions like attribution and risk adjustment for medically complex patients still need solutions that can only be answered with additional time and through CMS collaboration with the relevant professions.
We also solicited comment only on how often cost data should be provided in performance feedback under the Quality Payment Program, as well as, which data fields in the QRUR that would be useful to include in the Quality Payment Program performance feedback.
We received a number of comments on this item and appreciate the input received. As this was a request for comment only, we will take the feedback provided into consideration for the future as we continue to build performance feedback.
We proposed that MIPS eligible clinicians who participate in MIPS APMs would receive performance feedback in 2018 and future years of the Quality Payment Program, as technically feasible. We referred readers to section II.C.6.g.(5) of the proposed rule for additional information related to the proposal. A summary of comments on those proposals can be found in section II.C.6.g.(5) of this final rule with comment period.
As noted in the CY 2017 Quality Payment Program final rule (81 FR 77071), eligible clinicians who are not included in the definition of a MIPS eligible clinician during the first 2 years of MIPS (or any subsequent year) may voluntarily report on measures and activities under MIPS, but will not be subject to the payment adjustment. In the CY 2017 Quality Payment Program final rule (81 FR 77346), we summarized public comments requesting that eligible clinicians who are not required, but who voluntarily report on measures and activities under MIPS, should receive the same access to performance feedback as MIPS eligible clinicians; there, we indicated that we would take the comments into consideration in the future development of performance feedback. We proposed to furnish performance feedback to eligible clinicians and groups that do not meet the definition of a MIPS eligible clinician but voluntarily report on measures and activities under MIPS. We proposed that this would begin with data collected in performance period 2017, and would be available beginning July 1, 2018. Based on user and market research, we believe that making this information available would provide value in numerous ways. First, it would help clinicians who are excluded from MIPS in the 2017 performance period, but who may be considered MIPS eligible clinicians in future years, to prepare for participation in the Quality Payment Program when there are payment consequences associated with participation. Second, it would give all clinicians equal access to the CMS claims and benchmarking data available in performance feedback. And third, it would allow clinicians who may be interested in participating in an APM to make a more informed decision.
The following is a summary of the public comments received on the “Voluntary Clinician and Group Reporting” proposals and our responses:
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 section 1848(m)(3)(E) of the Act.
As previously stated in the CY 2017 Quality Payment Program final rule (81 FR 77347 through 77349), we will use a CMS-designated system as the mechanism for making performance feedback available, which we expect will be a web-based application. We expect to use a new and improved format for the next performance feedback, anticipated to be released around July 1, 2018. It will be provided via the Quality Payment Program Web site (
We also sought comment on how health IT, either in the form of an EHR or as a supplemental module, could better support the feedback related to participation in the Quality Payment Program and quality improvement in general. Specifically—
• Are there specific health IT functionalities that could contribute significantly to quality improvement?
• Are there specific health IT functionalities that could be part of a certified EHR technology or made available as optional health IT modules in order to support the feedback loop related to Quality Payment Program participation or participation in other HHS reporting programs?
• In what other ways can health IT support clinicians seeking to leverage quality data reports to inform clinical improvement efforts? For example, are there existing or emerging tools or resources that could leverage an API to provide timely feedback on quality improvement activities?
• Are there opportunities to expand existing tracking and reporting for use by clinicians, for example expanding the feedback loop for patient engagement tools to support remote monitoring of patient status and access to education materials?
We welcomed public comment on these questions.
We also noted in the proposed rule that we intend to continue to leverage third party intermediaries as a mechanism to provider performance feedback (82 FR 30155 through 30156). In the CY 2017 Quality Payment Program final rule (81 FR 77367 through 77386) we finalized that at least 4 times per year, qualified registries and QCDRs will provide feedback on all of the MIPS performance categories that the qualified registry or QCDR reports to us (improvement activities, advancing care information, and/or quality performance category). 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 or QCDR reports. The qualified registry or 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. In regard to third party intermediaries, we also noted we would look to propose “real time” feedback as soon as it is technically feasible.
We also noted in the proposed rule (82 FR 30156) that, per the policies finalized in the CY 2017 Quality Payment Program final rule (81 FR 77367 through 77386), we require qualified registries and QCDRs, as well as encourage other third party intermediaries (such as health IT vendors that submit data to us on behalf of a MIPS eligible clinician or group), to provide performance feedback to individual MIPS eligible clinicians and groups via the third party intermediary with which they are already working. We also noted that we understand that performance feedback is valuable to individual clinicians and groups, and seek feedback from third party intermediaries on when “real-time” feedback could be provided.
As discussed in the proposed rule (see 82 FR 30156), we plan to continue 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. We are exploring options with an API, which could allow authenticated third party intermediaries to access the same data that we use to provide confidential feedback to the individual clinicians and groups on whose behalf the third party intermediary reports for purposes of MIPS, in accordance with applicable law, including, but not limited to, the HIPAA Privacy and Security Rules. Our goal is to enable individual clinicians and groups to more easily access their feedback via the mechanisms and relationships they already have established. We referred readers to section II.C.10. of the proposed rule for additional information on Third Party Data Submission.
We solicited comment only on mechanisms used for performance feedback but did not propose any specific policy.
We received a number of comments on this item and appreciate the input received. As this was a request for comment only, we will take the feedback provided into consideration for the future as we continue to build performance feedback.
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 MIPS eligible clinicians, but to also receive information from professionals.
In the CY 2017 Quality Payment Program final rule (81 FR 77350), we discussed that we intended to explore the possibility of adding this feature to the CMS-designated system, such as a portal, in future years under MIPS. Although we did not make any specific proposals at this time, we sought comment on the features that could be developed for the expanded use of the feedback mechanism. This could be a feature where eligible clinicians and groups can send their feedback (for example, if they are experiencing issues accessing their data, technical questions about their data, etc.) to us through the Quality Payment Program Service Center or the Quality Payment Program Web site. We noted that we appreciate that eligible clinicians and groups may have questions regarding the Quality Payment Program information contained in their performance feedback. To assist
We solicited comment only on the receipt of information on features that could be developed for the expanded use of the feedback mechanism but did not propose any specific policy.
We received a number of comments on this item and appreciate the input received. As this was a request for comment only, we will take the feedback provided into consideration for the future as we continue to build performance feedback. As a reminder, we have already established a single helpdesk to address all questions related to the Quality Payment Program. Please visit our Web site at
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 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 that 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 proposed, beginning with the performance feedback provided around July 1, 2018, to make available to MIPS eligible clinicians and 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 and eligible clinicians by other suppliers and providers of services. We proposed to include as many of the following data elements as technically feasible: The name of such suppliers and providers of services; the types of items and services furnished and received; the dollar amount of services provided and received; and the dates that items and services were furnished. We proposed that the additional information would include historical data regarding the total, and components of, allowed charges (and other figures as determined appropriate). We proposed that this information be provided on the aggregate level; with the exception of data on items and services, as we could consider providing this data at the patient level, if clinicians find that level of data to be useful, although we noted it may contain personally identifiable information and protected health information. We proposed the date range for making this information available would be based on what is most helpful to clinicians, which could include the most recent data we have available, which as technically feasible would be from the previous 3 to 12-month period. We proposed to make this information available via the Quality Payment Program Web site, and as technically feasible, as part of the performance feedback. Finally, because data on items and services furnished is generally kept confidential, we proposed that access would be provided only after secure credentials are obtained.
The following is a summary of the public comments received on the “Additional Information—Type of Information” proposals and our responses:
Two commenters provided recommendations for the type of additional information to include in performance feedback. One commenter recommended that CMS create machine-readable APIs for the feedback mechanism so that vendors could then interpret “raw data,” thereby enabling them to develop visualization and processing tools to better understand this data. The commenter believes that providing all data and allowing community tools to filter out irrelevant data would provide more useful insights to MIPS eligible clinicians. Another commenter suggested inclusion of information about which patients are attributed to particular clinicians, which other clinicians have partnered in that care, and the care directly attributed to the clinician. The commenter believes that inclusion of this information would better balance the power between CMS to audit and potentially recover money with the opportunity for an eligible clinician to seek an informal review. Furthermore, the commenter observed that current feedback reports lack key details for understanding the methodologies used to arrive at the benchmarks and other calculations and encouraged CMS to generate a summary report of all measures across the MIPS domains per specialty and TIN size, including the “success” of each measure assessed.
In the proposed rule, we noted our intent (82 FR 30157), 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 stated our belief that this will encourage stakeholder commentary and make sure the result is the best possible format(s) for feedback.
To continue with our collaborative goal of working with the stakeholder community, we sought comment on the structure, format, content (for example, detailed goals, data fields, and elements) that would be useful for MIPS eligible clinicians and groups to include in performance feedback, including the data on items and services furnished, as discussed above. Additionally, we understand the term “performance feedback” may not be a meaningful phrase to communicate to clinicians or groups the scope of the data. Therefore, we sought comment on a more suitable term than “performance feedback.” User
Any suggestions on the template to be used for performance feedback or what to call “performance feedback” can be submitted to the Quality Payment Program Web site at
We received a number of comments on this item and appreciate the input received. As this was a request for comment only and we did nto make a proposal, we will take the feedback provided into consideration for the future as we continue to build performance feedback. 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 invite clinicians and groups that may have ideas they want to share, or if they would like to participate in user testing to email
In the CY 2017 Quality Payment Program final rule (81 FR 77546), we finalized at § 414.1385 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. We noted MIPS eligible clinicians who are scored under the APM scoring standard described in section II.C.6.g. of the proposed rule may request this targeted review. Although we did not propose any changes to the targeted review process, we provided information on the process that was finalized in the CY 2017 Quality Payment Program final rule (81 FR 77353 through 77358).
(1) MIPS eligible clinicians and groups have a 60-day period to submit a request for targeted review, which begins on the day we make 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 us.
(2) We will respond to each request for targeted review timely submitted and determine whether a targeted review is warranted. Examples under which a MIPS eligible clinician or group may wish to request a targeted review include, but are not limited to:
• 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, or a MIPS eligible clinician should not have received a performance category score).
(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 we request additional information from the MIPS eligible clinician or group, it must be provided and received by us 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.
In the CY 2017 Quality Payment Program final rule (81 FR 77546 through 77547), we finalized at § 414.1390(a) that we will selectively audit MIPS eligible clinicians and groups on a yearly basis. 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 we establish:
(1) 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 45 days of the data sharing request, or an alternate timeframe that is agreed to by us 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 us.
(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. We did not propose any changes to the requirements in section § 414.1390(a).
We indicated in the CY 2017 Quality Payment Program final rule 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 (81 FR 77362). We also indicated in the final rule that attestation requirements would be part of the submission process (81 FR 77360). We neglected to codify this requirement in regulation text of the CY 2017 Quality Payment Program final rule. Additionally, after further consideration since the final rule, the requirement is more in the nature of a certification, rather than an attestation. Thus, we proposed to revise § 414.1390 to add a new paragraph (b) that requires all MIPS eligible clinicians and groups that submit data and information to CMS for purposes of MIPS to certify to the best of their knowledge that the data submitted to CMS is true, accurate, and complete. We also proposed that the certification by the MIPS eligible clinician or group must accompany the submission.
We also indicated in the CY 2017 Quality Payment Program final rule that if a MIPS eligible clinician or group is found to have submitted inaccurate data for MIPS, we would reopen and revise the determination in accordance with the rules set forth at §§ 405.980 through 405.984 (81 FR 77362). We neglected to codify this policy in regulation text of the CY 2017 Quality Payment Program final rule and further, we did not include § 405.986, which is also an applicable rule in our reopening policy. We also finalized our approach to recoup incorrect 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. Thus, we proposed to revise § 414.1390 to add a new paragraph (c) that states we may reopen and revise a MIPS payment determination in accordance with the rules set forth at §§ 405.980 through 405.986.
In the CY 2017 Quality Payment Program final rule, we also indicated that MIPS eligible clinicians and groups should retain copies of medical records, charts, reports and any electronic data utilized for reporting under MIPS for up to 10 years after the conclusion of the performance period (81 FR 77360). We neglected to codify this policy in regulation text of the CY 2017 Quality Payment Program final rule. Thus, we proposed to revise § 414.1390 to add a new paragraph (d) that states that all MIPS eligible clinicians or groups that submit data and information to CMS for purposes of MIPS must retain such data and information for a period of 10 years from the end the MIPS Performance Period.
Finally, we indicated in the CY 2017 Quality Payment Program final rule, that, in addition to recouping any incorrect payments, we intend to use data validation and audits as an educational opportunity for MIPS eligible clinicians and groups and we note that this process will continue to include education and support for MIPS eligible clinicians and groups selected for an audit.
The following is a summary of the public comments received on the “Data Validation And Auditing” proposals and our responses:
Additionally, we note that the certification policy we finalized in the CY 2017 Quality Payment Program final rule (81 FR 77362) and proposed to codify at § 414.1390(b) in the CY 2017 Quality Payment Program proposed rule (82 FR 30254), requires MIPS eligible clinicians and groups to certify to the best of their knowledge that the data submitted to CMS is true, accurate, and complete. Thus, the evidence needed to support such an assertion would be the types of data and information we would request under § 414.1390. Finally, we refer readers to section II.C.10.g. of this final rule with comment period where we discuss the record retention policy for third party intermediaries. This policy is found at § 414.1400(j)(2), which we proposed to update in the CY 2018 Quality Payment Program proposed rule (82 FR 30255).
Flexible reporting options will provide eligible clinicians with options to accommodate different practices and make measurement meaningful. We believe that allowing eligible clinicians to participate in MIPS through the use of third party intermediaries that will collect or submit data on their behalf, will help us accomplish our goal of implementing a flexible program. We strongly encourage all third party intermediaries to work with their MIPS eligible clinicians to ensure the data submitted are representative of the individual MIPS eligible clinician's or group's overall performance for that measure or activity.
We use the term third party to refer to a qualified registry, QCDR, a health IT vendor, or other third party that obtains data from a MIPS eligible clinician's Certified Electronic Health Record Technology, or a CMS approved survey vendor. We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77363) and § 414.1400 of the CFR for our previously established policies regarding third party intermediaries.
In the CY 2018 Quality Payment Program proposed rule (82 FR 30158), we proposed to allow third party intermediaries to also submit on behalf of virtual groups. We proposed to revise § 414.1400(a)(1) to state that MIPS data may be submitted by third party intermediaries on behalf of an individual MIPS eligible clinician, group, or virtual group. We also refer readers to section II.C.4. of this final rule with comment period for a detailed discussion about virtual groups.
Additionally, we believe it is important that the MIPS data submitted by third party intermediaries is true, accurate, and complete. To that end, in the CY 2018 Quality Payment Program proposed rule (82 FR 30158), we proposed to add a requirement at § 414.1400(a)(5) stating that all data submitted to CMS by a third party intermediary on behalf of a MIPS eligible clinician, group or virtual group must be certified by the third party intermediary to the best of its knowledge as true, accurate, and complete. We also proposed that this certification accompany the submission and be made at the time of the submission. We solicited comments on these proposals.
Below is a summary of the public comments received on our proposals to: (1) Allow third party intermediaries to also submit on behalf of virtual groups; (2) require that all data submitted to us by a third party intermediary on behalf of a MIPS eligible clinician, group, or virtual group must be certified by the third party intermediary to the best of its knowledge as true, accurate, and complete; and (3) require that this certification occur at the time of the submission and accompany the submission.
In the CY 2017 Quality Payment Program final rule (81 FR 77364), we finalized the definition and capabilities of a QCDR. We finalized to require other information (described below) of QCDRs at the time of self-nomination. As previously established, 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 our Web site (81 FR 77363). 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 and measures for its clients as a condition of the entity's participation as a QCDR in MIPS (81 FR 77366). Failure to do so will preclude the QCDR from participation in MIPS in the subsequent year (81 FR 77366). In the CY 2018 Quality Payment Program proposed rule (82 FR 30159), we did not propose any changes to the definition or the capabilities of a QCDR. However, we did propose changes to the self-nomination process and the QCDR measure nomenclature. Additionally, we proposed a policy in which a QCDR may support an existing QCDR measure that is owned by another QCDR. The details of these proposals are discussed in more detail below.
In the CY 2017 Quality Payment Program final rule (81 FR 77365), we finalized the criteria to establish an entity seeking to qualify as a QCDR. In the CY 2018 Quality Payment Program proposed rule (82 FR 30159), we did not propose any changes to the criteria and refer readers to the CY 2017 Quality Payment Program final rule for the criteria to qualify as a QCDR.
In the CY 2017 Quality Payment Program final rule (81 FR 77365 through 77366), we finalized procedures and requirements for QCDRs to self-nominate. Additional details regarding self-nomination requirements for both the self-nomination form and the QCDR measure specification criteria and requirements can be found in the QCDR fact sheet and the self-nomination user guide, that are posted in the resource library of the Quality Payment Program Web site at
In the CY 2017 Quality Payment Program final rule (81 FR 77365 through 77366), we finalized the self-nomination period for the 2017 performance period to begin on November 15, 2016, and end on January 15, 2017. We also finalized for future years of the program, beginning with the 2018 performance period, for the self-nomination period to begin on September 1 of the year prior to the applicable performance period until November 1 of the same year. As an example, the self-nomination period for the 2018 performance period will begin on September 1, 2017, and will end on November 1, 2017. We believe an annual self-nomination process is the best process to ensure accurate information is conveyed to MIPS individual eligible clinicians and groups and accurate data is submitted for MIPS. 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 (82 FR 30159). As discussed in the CY 2017 Quality Payment Program final rule (81 FR 77365), a QCDR may chose not to continue participation in the program in
We do understand that some QCDRs may not have any changes to the measure and/or activity inventory they offer to their clients, and intend to participate in the MIPS for many years. In the CY 2018 Quality Payment Program proposed rule (82 FR 30159), we proposed beginning with the 2019 performance period, a simplified self-nomination process, to reduce the burden of self-nomination for those existing QCDRs that have previously participated in MIPS and are in good standing (not on probation or disqualified, as described below), and to allow for sufficient time for us to review data submissions and make determinations. Our proposals to simplify the process for QCDRs in good standing with no changes, minimal changes, and those with substantive changes are discussed below.
In the CY 2018 Quality Payment Program proposed rule (82 FR 30159), we proposed, beginning with the 2019 performance period, a simplified process for which existing QCDRs in good standing may continue their participation in MIPS, by attesting that the QCDR's previously approved: Data validation plan, services offered, cost associated with using the QCDR, measures, activities, and performance categories supported in the previous year's performance period of MIPS have no changes and will be used for the upcoming performance period. Specifically, existing QCDRs in good standing with no changes may attest during the self-nomination period, between September 1 and November 1, that they have no changes to their approved self-nomination application from the previous year of MIPS. By attesting that all aspects of their approved application from the previous year have not changed, these existing QCDRs in good standing would be spending less time completing the entire self-nomination form, as was previously required on a yearly basis.
Beginning with the 2019 performance period, existing QCDRs in good standing that would like to make minimal changes to their previously approved self-nomination application from the previous year, may submit these changes, and attest to no other changes from their previously approved QCDR application, for CMS review during the self-nomination period, from September 1 to November 1. In the CY 2018 Quality Payment Program proposed rule (82 FR 30159), we proposed that minimal changes include: Limited changes to their performance categories, adding or removing MIPS quality measures, and adding or updating existing services offered, and/or the cost associated with using the QCDR.
In the CY 2018 Quality Payment Program proposed rule (82 FR 30159) we stated that existing QCDRs in good standing, may also submit for CMS review and approval, substantive changes to measure specifications for existing QCDR measures that were approved the previous year, or submit new QCDR measures for CMS review and approval without having to complete the entire self-nomination application process, which is required to be completed by a new QCDR. By attesting that certain aspects of their approved application from the previous year have not changed, existing QCDRs in good standing would be spending less time completing the entire self-nomination form, as was previously required on a yearly basis. We are proposing such a simplified process to reduce the burden of self-nomination for those existing QCDRs who have previously participated in MIPS, and are in good standing (not on probation or disqualified, as described later in this section) and to allow for sufficient time for us to review data submissions and to make determinations on the standing of the QCDRs. We note that substantive changes to existing QCDR measure specifications or any new QCDR measures would have to be submitted for CMS review and approval by the close of the self-nomination period. This proposed process will allow existing QCDRs in good standing to avoid completing the entire application annually, as is required in the existing process, and in alignment with the existing timeline. We requested comments on this proposal.
In the development of the above policy, we had also reviewed the possibility of offering a multi-year approval, in which QCDRs would be approved for a continuous 2-year increment of time. However, we are concerned that utilizing a multi-year approval process would restrict QCDRs by having them support the same fixed services they had for the first year, and would not provide QCDRs with the flexibility to add or remove services, measures, and/or activities based on their QCDR capabilities for the upcoming program year. Furthermore, under a multi-year approval process, QCDRs would not be able to make changes to their organizational structure (as described above) and would also create complications in our process for placing QCDRs who perform poorly (during the first year) on probation or disqualifying them (as described below). Moreover, a multi-year approval process would not take into consideration potential changes in criteria or requirements of participation for QCDRs, that may occur as the MIPS program develops through future program years. For the reasons stated above, we believe an annual self-nomination period is appropriate. We understand that stakeholders are interested in a multi-year approval process, for that reason we intend to revisit the topic once we have gained additional experience with the self-nomination process under MIPS. We seek comment from stakeholders as to how they believe our aforementioned concerns with multi-year approvals of QCDRs can be resolved.
In the CY 2018 Quality Payment Program proposed rule (82 FR 30159), for the 2018 performance period and beyond, we proposed that self-nomination information must be submitted via a web-based tool, and to eliminate the submission method of email. We noted that we will provide further information about the web-based tool at
Below is a summary of the public comments received on the following proposals: (1) A simplified self-nomination process for existing QCDRs in good standing; and (2) To eliminate the self-nomination submission method of email.
Under our proposals, we are clarifying that beginning with the 2019 performance period, we are clarifying that any previously approved QCDR in good standing (meaning, those that are not on probation or disqualified) that wishes to self nominate using the simplified process can attest, in whole or in part, that their previously approved form is still accurate and applicable. Specifically, under this process, QCDRs with no changes can attest that their previously submitted QCDR self-nomination form in its entirety remains the same. Similarly, previously approved QCDRs in good standing that wish to self nominate using the simplified process and have minimal changes can attest to aspects of their previously submitted form that remain the same, but would additionally be required to update the self-nomination form to reflect any minimal changes for CMS review. As stated in our proposal above, minimal changes include, but are not limited to: Limited changes to performance categories, adding or removing MIPS quality measures, and adding or updating existing services and/or cost information.
Furthermore, under our proposal, we are also clarifying that any previously approved QCDR in good standing that wishes to self nominate using the simplified process and has substantive changes may submit those substantive changes while attesting that the remainder of their application remains the same from the previous year. We are clarifying here that substantive changes include, but are not limited to: Updates to existing (approved) QCDR measure specifications, new QCDR measures for consideration, changes in the QCDR's data validation plan, or changes in the QCDR's organizational structure (for example, if a regional health collaborative or specialty society wishes to partner with a different data submission platform vendor that would support the submission aspect of the QCDR). This process mirrors that for minimal changes. For example, if a previously approved QCDR in good standing would like to submit changes only to it's QCDR measures, the QCDR can attest that there are no changes to their self-nomination form, and provide the updated QCDR measures specifications for CMS review and approval. We are also clarifying that the information required to be submitted for any changes would be the same as that required under the normal self-nomination process. We refer reader to the CY 2017 Quality Payment Program final rule (81 FR 77366 through 77367), as well as (81 FR 77374 through 77375) and § 414.1400(f). For example, if a QCDR would like to include one new QCDR measure, it would be required to submit: Descriptions and narrative specifications for each measure, the name or title of the QCDR measure, NQF number (if NQF endorsed), descriptions of the denominator, numerator, denominator exceptions (when applicable), denominator exclusions (when applicable), risk adjustment variables (when applicable), and risk adjustment algorithms. We expect that the measure will address a gap in care, and prefer outcome or high priority measures. Documentation or “check box” measures are discouraged. Measures that have a very high performance rate already, or extremely rare gaps in care will unlikely be approved for inclusion (81 FR 77374 through 77375).
We disagree with the recommendation that QCDRs only need to reapply if they make substantial organization or operational changes. This would not take into consideration potential changes in criteria or requirements of participation for QCDRs, as the MIPS program develops through future program years. Furthermore, we believe self-nomination should occur on an annual basis to account for QCDRs that may perform poorly and thereby need to be placed on probation or precluded from participation the following year. We thank the commenter for their
We understand the commenters concerns, but would like to note we have been working to implement process improvements and develop additional standardization for the 2018 performance period self-nomination and QCDR measure review, in which consistent feedback is communicated to vendors, additional time is given to vendors to respond to requests for information, and more detailed rationales are provided for rejected QCDR measures. Furthermore, through our review, we intend to communicate the timeframe in which a decision re-examination can be requested should we reject QCDR measures. In order to improve predictability and avoid delays or misunderstandings, we have made updates to the self-nomination form to outline all of the information needed during the review process. We refer readers to:
Beginning with the 2019 performance period, previously approved QCDRs in good standing (meaning, those that are not on probation or disqualified) that wishes to self nominate using the simplified process can attest, in whole or in part, that their previously approved form is still accurate and applicable. Specifically, under this process, QCDRs with no changes can attest that their previously submitted QCDR self-nomination form in its entirety remains the same. Similarly, previously approved QCDRs in good standing that wish to self nominate using the simplified process and have minimal changes can attest to aspects of their previously submitted form that remain the same, but would additionally be required to outline any minimal changes for CMS review and approval. Minimal changes include, but are not limited to: Limited changes to performance categories, adding or removing MIPS quality measures, and adding or updating existing services and/or cost information. Furthermore, a previously approved QCDRs in good standing that wishes to self nominate using the simplified process and has substantive changes may submit those substantive changes while attesting that the remainder of their application remains the same from the previous year. Substantive changes include, but are not limited to: Updates to existing (approved) QCDR measure specifications, new QCDR measures for consideration, changes in the QCDR's data validation plan, or changes in the QCDR's organizational structure (for example, if a regional health collaborative or speciality society wishes to partner with a different data submission platform vendor that would support the submission aspect of the QCDR). We are also clarifying that the information required to be submitted for any changes would be the same as that required under the normal self-nomination process as discussed previously in this final rule with comment period.
Furthermore, we are finalizing our proposal, as proposed, that beginning with the 2018 performance period, that self-nomination applications must be submitted via a web-based tool, and that the email method of submission will be eliminated.
For the 2018 performance period and future performance periods, we are finalizing the following proposal: That self-nomination submissions will occur via a web-based tool rather than email; and for the 2019 performance period and future performance periods, we are finalizing the availability of a simplified
In the CY 2017 Quality Payment Program final rule (81 FR 77366 through 77367), we finalized the information a QCDR must provide to us at the time of self-nomination. In the CY 2018 Quality Payment Program proposed rule (82 FR 30159 through 30160), we proposed to replace the term “non-MIPS measures” with “QCDR measures” for future program years, beginning with the 2018 performance period. We noted that although we proposed a change in the term referring to such measures, we did not propose any other changes to the information a QCDR must provide to us at the time of self-nomination under the process finalized in the CY 2017 Quality Payment Program final rule. We referred readers to the CY 2017 Quality Payment Program final rule for specific information requirements. However, we refer readers to section II.C,10,a,(5)(b) of this final rule with comment period, where we are modifying our proposal that as a part of the self-nomination review process for 2018 and future years, we will assign QCDR measure IDs to approved QCDR measures, and the same measure ID must be used by any other QCDRs that have received permission to also report the measure. We also note that information required under the newly finalized simplified process is discussed in the previous section of this final rule with comment period. Additionally, as finalized in section II.C.10.b.(2)(b)(iii) of this final rule with comment period, we will only accept self-nomination applications through the web-based tool and will provide additional guidance as to what information needs to be submitted for QCDR measure specifications through the 2018 Self-Nomination User Guide that will be posted on our Web site.
The following is a summary of the public comments received on the “Information Required at the Time of Self-Nomination” proposal and our response:
For the 2018 performance period and future performance periods, we are finalizing the following proposal: That the term “QCDR measures” will replace the term “non-MIPS measures”.
In the CY 2017 Quality Payment Program final rule (81 FR 77367 through 77374), we finalized that a QCDR must perform specific functions to meet the criteria for data submission. While we did not propose any changes to the criteria for data submission in the CY 2018 Quality Payment Program proposed rule (82 FR 30160), we clarified the criteria for QCDR data submission. For data submissions, QCDRs:
• Must have in place mechanisms for transparency of data elements and specifications, risk models and measures. That is, we expect that the QCDR 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. QCDR measure specifications should be provided at a level of detail that is comparable to what is posted by us on the CMS Web site for MIPS quality measure specifications.
• Approved QCDRs may post the MIPS quality measure specifications on their Web site, if they so choose. If the MIPS quality measure specifications are posted by the QCDRs, they must be replicated exactly the same as the MIPS quality measure specifications as posted on the CMS Web site.
• Enter into and maintain with its participating MIPS eligible clinicians, an appropriate Business Associate Agreement that complies with the HIPAA Privacy and Security Rules. Ensure that Business Associate Agreement 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.
• Must provide timely feedback at least 4 times a year, on all of the MIPS performance categories that the QCDR will report to us. We refer readers to section II.C.9.a. of the CY 2018 Quality Payment Program proposed rule for additional information on third party intermediaries and performance feedback.
• For purposes of distributing performance feedback to MIPS eligible clinicians, we encourage QCDRs to assists MIPS eligible clinicians in the update of their email addresses in CMS systems—including PECOS and the Identity and Access System—so that they have access to feedback as it becomes available on
As noted in the CY 2017 Quality Payment Program final rule (81 FR 77370), we will on a case-by-case basis allow QCDRs and qualified registries to request review and approval for additional MIPS measures throughout the performance period. In the CY 2018 Quality Payment Program proposed rule (82 FR 30160), we clarified and explained that this flexibility would
In the CY 2017 Quality Payment Program final rule (81 FR 77374 through 77375), we specified at § 414.1400(f) that the QCDR must provide specific QCDR measures specifications criteria. We generally intend to apply a process similar to the one used for MIPS measures to QCDR measures that have been identified as topped out. In the CY 2018 Quality Payment Program proposed rule (82 FR 30160), we did not propose any changes to the QCDR measure specifications criteria and refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77374 through 77375) for the specification requirements a QCDR must submit for each measure, activity, or objective the QCDR intends to submit to CMS. Though we did not make proposals around the QCDR measure specifications themselves, in the CY 2018 Quality Payment Program proposed rule, (82 FR 30160) we did make a number of clarifications around alignment with the measures development plan, previously retired measures, and the public posting of the QCDR measure specifications. Additionally, we proposed to allow QCDR vendors to seek permission from another QCDR to use an existing approved QCDR measure. Lastly, we sought comment from stakeholders around requiring QCDRs to fully develop and test their QCDR measures by the time of self-nomination. These are discussed in more detail below.
In the CY 2017 Quality Payment Program final rule (81 FR 77375), we finalized that we will consider all QCDR (non-MIPS) measures submitted by the QCDR, but that the measures must address a gap in care and outcome or other high priority measures are preferred. In the CY 2018 Quality Payment Program proposed rule (82 FR 30160), we clarified that we encourage alignment with our Measures Development Plan.
In the CY 2017 Quality Payment Program final rule (81 FR 77375), we finalized that measures that have very high performance rates already or address extremely rare gaps in care (thereby allowing for little or no quality distinction between MIPS eligible clinicians) are also unlikely to be approved for inclusion. In the CY 2018 Quality Payment Program proposed rule (82 FR 30160), we also clarified that we will likely not approve retired measures that were previously in one of CMS's quality programs, such as the Physician Quality Reporting System (PQRS) program, if proposed as QCDR measures. This includes measures that were retired due to being topped out, as defined in section II.C.6.c.(2) of the CY 2018 Quality Payment Program proposed rule, due to high-performance or measures retired due to a change in the evidence supporting the use of the measure.
Lastly, in the CY 2017 Quality Payment Program final rule (81 FR 77375), we finalized that the QCDR must publicly post the measure specifications (no later than 15 days following our approval of these measure specifications) for each QCDR measure it intends to submit for MIPS. In the CY 2018 Quality Payment Program proposed rule (82 FR 30160), we clarified that 15 days refers to 15 calendar days, not business days. The QCDR must publicly post the measure specifications no later than 15 calendar days following our approval of these measures specifications for each QCDR measure it intends to submit for MIPS. It is important for QCDRs to post their QCDR measure specifications on their Web site in a timely manner, so that the specifications are readily available for MIPS eligible clinicians and groups to access and review in determining which QCDR measures they intend to report on for the performance period.
In the CY 2018 Quality Payment Program proposed rule (82 FR 30160), beginning with the 2018 performance period and for future program years, we proposed that QCDR vendors may seek permission from another QCDR to use an existing measure that is owned by the other QCDR. If a QCDR would like report on an existing QCDR measure that is owned by another QCDR, they must have permission from the QCDR that owns the measure that they can use the measure for the performance period. Permission must be granted at the time of self-nomination, so that the QCDR that is using the measure can include the proof of permission for CMS review and approval for the measure to be used in the performance period. The QCDR measure owner (QCDR vendor) would still own and maintain the QCDR measure, but would allow other approved QCDRs to utilize their QCDR measure with proper notification. We noted that the proposal would help to harmonize clinically similar measures and limit the use of measures that only slightly differ from another. We invited comments on this proposal.
In the CY 2018 Quality Payment Program proposed rule (82 FR 30160), we sought comment for future rulemaking, on requiring QCDRs that develop and report on QCDR measures, to fully develop and test (that is, conduct reliability and validity testing) their QCDR measures, by the time of submission of the new measure during the self-nomination process. We received a number of comments on this item and appreciate the input received. As this was a request for comment only, we will take the feedback provided into consideration for possible inclusion in future rulemaking.
The following is a summary of the public comments received on the “QCDR Measure Specifications Criteria” proposals and our responses:
We are also clarifying and updating at § 414.1400(f)(3) that the QCDR must publicly post the measure specifications no later than 15 calendar days, not business days, following our approval of these measures specifications for each approved QCDR measure.
For the 2018 performance period and future performance periods, we are finalizing the following proposal: That QCDRs may report on QCDR measures owned by another QCDR with the appropriate permissions; and we clarify that QCDRs must publicly post QCDR measure specifications no later than 15 calendar days following our approval of the measures specifications.
In the CY 2017 Quality Payment Program final rule (81 FR 77375 through 77377), we finalized the definition and types of QCDR quality measures for purposes of QCDRs submitting data for the MIPS quality performance category. In the CY 2018 Quality Payment Program proposed rule (82 FR 30160), we did not propose any changes to the criteria on how to identify QCDR quality measures. However, in the proposed rule, we clarified that QCDRs are not limited to reporting on QCDR measures, and may also report on MIPS measures as indicated in section II.C.10.b.(4) of this final rule with comment period, the QCDR data submission criteria section.
As the MIPS program progresses in its implementation, we are interested in elevating the standards for which QCDR measures are selected and approved for use. We are interested in further aligning our QCDR measure criteria with that used under the Call for Quality Measures process, as is described in the CY 2017 Quality Payment Program final rule (81 FR 77151). We seek comment in this final rule with comment period, on whether the standards used for selecting and approving QCDR measures should align more closely with the standards used for the Call for Quality Measures process for consideration in future rule making.
In the CY 2017 Quality Payment Program final rule (81 FR 77377), we finalized policy on the collaboration of entities to become a QCDR. In the CY 2018 Quality Payment Program proposed rule (82 FR 30161), we did not propose any changes to this policy.
In the CY 2017 Quality Payment Program final rule (81 FR 77382), we finalized definitions and criteria around health IT vendors that obtain data from MIPS eligible clinicians CEHRT. We note that, a health IT vendor that serves as a third party intermediary to collect or submit data on behalf MIPS eligible clinicians may or may not also be a
In the CY 2018 Quality Payment Program proposed rule (82 FR 30161), we did not propose any changes to this policy in the proposed rule. However, we sought comment for future rulemaking regarding the potential shift to seeking alternatives which might fully replace the QRDA III format in the Quality Payment Program in future program years. We received a number of comments on this item and appreciate the input received. As this was a request for comment only, we will take the feedback provided into consideration for possible inclusion in future rulemaking.
In the CY 2017 Quality Payment Program final rule (81 FR 77382 through 77386), we finalized the definition and capability of qualified registries. As previously established, if an entity becomes qualified as a qualified registry, they will need to sign a statement confirming that this information is currect prior to listing it on our Web site (81 FR 77383). Once we post the qualified registry on our Web site, including the services offered by the qualified registry, we will require the qualified registry to support these services and measures for its clients as a condition of the entity's participation as a qualified registry in MIPS (81 FR 77383). Failure to do so will preclude the qualified registry from participation in MIPS in the subsequent year (81 FR 77383). In the CY 2018 Quality Payment Program proposed rule (82 FR 30161), we did not propose any changes to the definition or the capabilities of qualified registries. However, we did propose changes to the self-nomination process for the 2019 performance period. This is discussed in detail below.
In the CY 2017 Quality Payment Program final rule (81 FR 77383), we finalized the requirements for the establishment of an entity seeking to qualify as a registry. In the CY 2018 Quality Payment Program proposed rule (82 FR 30161), we did not propose any changes to the criteria regarding the establishment of an entity seeking to qualify as a registry criteria.
In the CY 2017 Quality Payment Program final rule (81 FR 77383 through 77384), we finalized procedures and requirements for qualified registries to self-nominate. Additional details regarding self-nomination requirements for the self-nomination form can be found in the qualified registry fact sheet and the self-nomination user guide, that are posted in the resource library of the Quality Payment Program Web site at
For the 2018 performance period, and for future years of the program, we finalized in the CY 2017 Quality Payment Program final rule (81 FR 77383) and § 414.1400(g) a self-nomination period for qualified registries from September 1 of the year prior to the applicable performance period, until November 1 of the same year. For example, for the 2018 performance period, the self-nomination period would begin on September 1, 2017, and end on November 01, 2017. Entities that desire to qualify as a qualified registry for purposes of MIPS for a given performance period will need to provide all requested information to us at the time of self-nomination and would need to self-nominate for that performance period (81 FR 77383). Having previously qualified as a qualified registry does not automatically qualify the entity to participate in subsequent MIPS performance periods (81 FR 77383). Furthermore, prior performance of the qualified registry (when applicable) will be taken into consideration in approval of their self-nomination. 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 in section II.C.10.f. of this final rule with comment period. 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. In this final rule with comment period, we are establishing a simplified process for existing qualified registries in good standing.
We do understand that some qualified registries may not have any changes to the measures and/or activity inventory they offer to their clients and intend to participate in MIPS for many years. In the CY 2018 Quality Payment Program proposed rule (82 FR 30161), we proposed, beginning with the 2019 performance period, a simplified process, to reduce the burden of self-nomination for those existing qualified registries that have previously participated in MIPS and are in good standing (not on probation or disqualified, as described below), and to allow for sufficient time for us to review data submissions and make determinations. Our proposals to simplify the process for existing qualified registries in good standing with no changes, minimal changes, and those with substantive changes are discussed below.
In the CY 2018 Quality Payment Program proposed rule (82 FR 30161), we proposed, beginning with the 2019 performance period, a simplified process for which existing qualified registries in good standing may continue their participation in MIPS, by attesting that the qualified registry's previously approved: Data validation plan, cost to use the qualified registry, measures, activities, services, and performance categories used in the previous year's performance period of MIPS have no changes and will be used for the upcoming performance period. Specifically, existing qualified registries in good standing with no changes may attest during the self-nomination period, between September 1 and November 1, that they have no changes to their approved self-nomination application from the previous year from the previous year of MIPS. By attesting that all aspects of their approved application from the previous year have not changed, these existing qualified registries in good standing would be spending less time completing the entire self-nomination form, as was previously required on a yearly basis.
Beginning with the 2019 performance period, existing qualified registries in good standing that would like to make minimal changes to their previously approved self-nomination application from the previous year, may submit these changes, and attest to no other changes from their previously approved qualified registry application, for CMS review during the self-nomination period, from September 1 to November 1. In the CY 2018 Quality Payment Program proposed rule (82 FR 30161), we proposed that minimal changes
In the CY 2018 Quality Payment Program proposed rule (82 FR 30161), we inadvertently left out language in the preamble that explained our proposed updates to § 414.1400(g), which were included in the proposed amendments to 42 CFR chapter IV at 82 FR 30255, and stated that:
For the 2018 performance period and future years of the program, the qualified registry must self-nominate from September 1 of the prior year until November 1 of the prior year. Entities that desire to qualify as a qualified registry for a given performance period must self-nominate and provide all information requested by CMS at the time of self-nomination. Having qualified as a qualified registry does not automatically qualify the entity to participate in subsequent MIPS performance periods. Beginning with the 2019 performance period, existing qualified registries that are in good standing may attest that certain aspects of their previous year's approved self-nomination have not changed and will be used for the upcoming performance period. CMS may allow existing qualified registries in good standing to submit minimal or substantive changes to their previously approved self-nomination form from the previous year, during the annual self-nomination period, for CMS review and approval without having to complete the entire qualified registry self-nomination application process.
This language mirrors that proposed for QCDRs (82 FR 30255) and finalized above in section II.C.10.b. of this final rule with comment period. Our intention was to parallel the simplified self-nomination process available to QCDRs in good standing beginning with the 2019 performance period, including for substantive changes, such that Qualified Registries could do the same. The update to § 414.1400(g), as included in the proposed rule, allows a qualified registry to also submit substantive changes, in addition to minor changes, through the simplified self-nomination process. Therefore, we are clarifying here in this final rule with comment period that beginning with the 2019 performance period, CMS may allow existing qualified registries in good standing to submit substantive changes, in addition to minimal changes as discussed in the section above, to their previously approved self-nomination form from the previous year, during the annual self-nomination period. We are also clarifying that substantive changes may include, but are not limited to: Updates to a qualified registry's data validation plan, or a change in the qualified registry's organization structure that would impact any aspect of the qualified registry. We are also clarifying that the information required to be submitted for any changes would be the same as that required under the normal self-nomination process as previously finalized. We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77383 through 77384), where we finalized the information a qualified registry must provide to us at the time of self-nomination as well as (82 FR 30162) and § 414.1400(g).
In the development of the above proposal, we had also reviewed the possibility of offering a multi-year approval, in which qualified registries would be approved for a 2-year increment of time. However, we are concerned that utilizing a multi-year approval process would restrict qualified registries by having them support the same fixed services they had for the first year, and would not provide qualified registries with the flexibility to add or remove services, measures, and/or activities based on their qualified registry's capabilities for the upcoming year. Furthermore, under a multi-year approval process, qualified registries would not be able to make changes to their organizational structure (as noted above) and would also create complications in our process for placing qualified registries who perform poorly (during the first year) on probation or disqualifying them (as described below). Moreover, a multi-year approval process would not take into consideration potential changes in criteria or requirements of participation for qualified registries, that may occur as the MIPS program develops through future program years. For the reasons stated above, we believe an annual self-nomination period is appropriate. We understand that stakeholders are interested in a multi-year approval process, for that reason we intend to revisit the topic once we have gained additional experience with the self-nomination process under MIPS. We seek comment from stakeholders as to how they believe our aforementioned concerns with multi-year approvals of qualified registries can be resolved.
In the CY 2018 Quality Payment Program proposed rule (82 FR 30162), for the 2018 performance period and beyond, we proposed that self-nomination information must be submitted via a Web-based tool, and to eliminate the submission method of email. We noted that we will provide further information about the web-based tool at
We invited public comment on: (1) Our proposals regarding a simplified self-nomination process beginning with the 2019 performance period for previously approved qualified registries in good standing; (2) multi-year approvals; and (3) our proposal to submit self-nomination information via a web-based tool. The following is a summary of the public comments received on the “Self-Nomination Period” proposals and our responses:
Under our proposals, we are clarifying that beginning with the 2019 performance period, any previously approved qualified registry in good standing (meaning, those that are not on probation or disqualified) that wishes to self nominate using the simplified process can attest, in whole or in part, that their previously approved form is still accurate and applicable. Specifically, under this process, qualified registries with no changes can attest that their previously submitted qualified registry self-nomination form in its entirety remains the same. Similarly, previously approved qualified registries in good standing that wish to self nominate using the simplified process and have minimal changes can attest to aspects of their previously submitted form that remain the same, but would additionally be required to outline any minimal changes for our review and approval through the self-nomination review process. Additional instructions regarding the completion of this simplified self-nomination form will be available on our Web site prior to the start of the self-nomination process for the 2019 performance period. As stated in our proposal above, minimal changes include, but are not limited to: Limited changes to performance categories, adding or removing MIPS quality measures, and adding or updating existing services and/or cost information.
Furthermore, we are also clarifying that any previously approved qualified registry in good standing that wishes to self nominate using the simplified process can submit substantive changes while attesting that the remainder of their application remains the same from the previous year. Substantive changes include, but are not limited to: Updates to the qualified registry's data validation plan, or a change in the qualified registry's organization structure that would impact any aspect of the qualified registry. For example, if a previously approved qualified registry in good standing would like to submit changes only to it's MIPS quality measures, the qualified registry can attest that there are no changes to their self-nomination form, and provide updated MIPS quality measures information for CMS review and approval. We are also clarifying that the information required to be submitted for any changes would be the same as that required under the normal self-nomination process. We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77383 through 77384), where we finalized the information a qualified registry must provide to us at the time of self-nomination as well as (82 FR 30162) and § 414.1400(g).
Beginning with the 2019 performance period, any previously approved qualified registry in good standing (meaning, those that are not on probation or disqualified) that wishes to self nominate using the simplified process can attest, in whole or in part, that their previously approved form is still accurate and applicable. Specifically, under this process, qualified registries with no changes can attest that their previously submitted qualified registry self-nomination form in its entirety remains the same. Similarly, previously approved qualified registries in good standing that wish to self nominate using the simplified process and have minimal changes can attest to aspects of their previously submitted form that remain the same, but would additionally be required to update and describe any minimal changes in their self-nomination application for our review and approval. Minimal changes include, but are not limited to: limited changes to performance categories, adding or removing MIPS quality measures, and adding or updating existing services and/or cost information.
We are also clarifying that any previously approved qualified registry in good standing that wishes to self nominate using the simplified process and has substantive changes may submit those substantive changes while attesting that the remainder of their application remains the same from the previous year. Substantive changes include, but are not limited to: Changes in the qualified registry's data validation plan, or changes in the qualified registry's organizational change in the qualified registry's organization structure that would impact any aspect of the qualified registry. We are clarifying that the information required to be submitted for any changes would be the same as that required under the normal self-nomination process as previously finalized. Therefore, we are finalizing at § 414.1400(g) the following: for the 2018 performance period and future years of the program, the qualified registry must self-nominate from September 1 of the prior year until
We are also finalizing, as proposed, that for the 2018 performance period and beyond: (1) Self-nomination information must be submitted via a web-based tool, and (2) we are eliminating the submission method of email. We will provide further information on the web-based tool at
We finalized in the CY 2017 Quality Payment Program final rule (81 FR 77384) that a qualified registry must provide specific information to us at the time of self-nomination. In the CY 2018 Quality Payment Program proposed rule (82 FR 30162), we did not propose any changes to this policy.
In the CY 2017 Quality Payment Program final rule (81 FR 77386), we finalized the criteria for qualified registry data submission. In the CY 2018 Quality Payment Program proposed rule (82 FR 30162), we did not propose any changes to this policy. Although no changes were proposed, however we made two clarifications to the existing criteria:
• In the CY 2017 Quality Payment Program final rule (81 FR 77385), we specify that qualified registries must enter into and maintain with its participating MIPS eligible clinicians an appropriate MIPS eligible clinicians an appropriate Business Associate agreement. The Business Associate agreement should provide 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 or patient specific data on Medicare and non-Medicare beneficiaries on behalf of individual MIPS eligible clinicians and groups. As stated in the CY 2018 Quality Payment Program proposed rule (82 FR 30162), we are clarifying that the Business Associate agreement must comply with the HIPAA Privacy and Security Rules.
• We had finalized in the CY 2017 Quality Payment Program final rule (81 FR 77384) that timely feedback be provided at least four times a year, on all of the MIPS performance catgeories that the qualified registry will report to us. We are clarifying that readers should refer to section II.C.9.a. of this rule for additional information on third party intermediaries and performance feedback.
We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77370) for additional information on allowing qualified registries ability to request CMS approval to support additional MIPS quality measures.
In the CY 2017 Quality Payment Program final rule (81 FR 77386), we finalized the definition, criteria, required forms, and vendor business requirements needed to participate in MIPS as a survey vendor. In the CY 2018 QPP proposed rule (82 FR 30162), we did not propose changes to those policies. However, in the CY 2016 PFS rule (80 FR 71143) we heard from some groups that it would be useful to have a final list of CMS-approved survey vendors to inform their decision on whether or not to participate in the CAHPS for MIPS survey. Therefore, in the proposed rule, we proposed to change the survey vendor application deadline in order to timely display a final list of CMS-approved survey vendors. This is discussed in more detail below.
In the CY 2017 Quality Payment Program final rule (81 FR 77386), we finalized a survey vendor application deadline of April 30th of the performance period. We also finalized that survey vendors would be required to undergo training, to meet our standards on how to administer the survey, and submit a quality assurance plan (81 FR 77386). In the CY 2018 Quality Payment Program proposed rule (82 FR 30162-30163), we noted that the current CAHPS for MIPS survey timeframe from the 2017 performance period conflicts with the timeframe in which groups can elect to participate in the CAHPS for MIPS survey. We would like to clarify that the current CAHPS for MIPS survey vendor application deadline from the 2017 performance period of April 30th conflicts with the timeframe in which groups can elect to participate in the CAHPS for MIPS survey, of April 1st to June 30th. In order to provide a final list of CMS-approved survey vendors earlier in the timeframe during which groups can elect to participate in the CAHPS for MIPS survey, an earlier vendor application deadline would be necessary. This could be accomplished by having a rolling application period, where vendors would be able to submit an application by the end of the first quarter. The rolling application period that would end by the first quarter would allow us to adjust the application deadline beyond January 31st on a year to year basis, based on program needs. However, in addition to submitting a vendor application, vendors must also complete vendor training and submit a Quality Assurance Plan and we need to allow sufficient time for these requirements as well.
Therefore, in the CY 2018 Quality Payment Program proposed rule (82 FR 30162 through 30163), we proposed for the 2018 performance period of the Quality Payment Program and future years that the vendor application deadline would be January 31st of the applicable performance year or a later date specified by CMS. The proposal would allow us to adjust the application deadline beyond January 31st on a year to year basis, based on program needs. We would notify vendors of the application deadline to become a CMS-approved survey vendor through additional communications and postings on the Quality Payment Program Web site,
We did not receive any comments related to this proposal.
At § 414.1400(k), we finalized the process for placing third party intermediaries on probation and for disqualifying such entities for failure to meet certain standards established by us (81 FR 77386). 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 or the following performance period, as applicable (81 FR 77389). We refer readers to the CY 2018 Quality Payment Program proposed rule (81 FR 30163) for additional information regarding the probation and disqualification process.
In the CY 2017 Quality Payment Program final rule with comment (81 FR 77388), we stated that MIPS eligible clinicians are ultimately responsible for the data that are submitted by their third party intermediaries and expect that MIPS eligible clinicians and groups should ultimately hold their third party intermediaries accountable for accurate reporting. We also stated that we would consider from the MIPS eligible clinicians and groups perspective, cases of vendors leaving the marketplace (81 FR 77388) during the performance period on a case by case basis, but that we will not consider cases prior to the performance period. Furthermore, we stated that we would need proof that the MIPS eligible clinician had an agreement in place with the vendor at the time of their withdrawal from the marketplace.
While we did not propose any changes to the process of probation and disqualification of a third party intermediary in the CY 2018 Quality Payment Program proposed rule (82 FR 30163), we received a number of comments on this item and appreciate the input received.
In the CY 2017 Quality Payment Program final rule (81 FR 77389), we finalized 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 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 us 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 us for MIPS for a minimum of 10 years; and
(3) For the purposes of auditing, we may request any records or data retained for the purposes of MIPS for up to 6 years and 3 months.
In the CY 2018 Quality Payment Program proposed rule (82 FR 30163), we proposed to update § 414.1400(j)(2) from stating that the entity must retain all data submitted to us for MIPS for a minimum of 10 years to state that the entity must retain all data submitted to us for purposes of MIPS for a minimum of 10 years from the end of the MIPS performance period.
We invited public comment on our proposal, but did not receive any.
Similarly, we finalized in the CY 2017 Quality Payment Program final rule (81 FR 77389-77390) at § 414.1400(j)(3) that for the purposes of auditing, we may request any records or data retained for the purposes of MIPS for up to 6 years and 3 months. While we did not propose any changes or updates to this policy in the CY 2018 QPP proposed rule, based on our modifications to § 414.1390(d) and § 414.1400(j)(2), as discussed previously in this final rule with comment period, we are also updating § 414.1400(j)(3) to reflect these same changes and allow us to request any records or data retained for the purposes of MIPS for up to 6 years from the end of the MIPS performance period. We believe this change will promote consistent and cohesive policies across this program.
This section contains the approach for public reporting on Physician Compare for year 2 of the Quality Payment Program (2018 data available for public reporting in late 2019) and future years, including MIPS, APMs, and other information as required by the MACRA and building on the MACRA public reporting policies previously finalized (81 FR 77390 through 77399).
Physician Compare draws its operating authority from section 10331(a)(1) of the Affordable Care Act. As required by section 10331(a)(1) of the Affordable Care Act, 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 initiated a phased approach to public reporting performance scores that provide comparable information on quality and patient experience measures for reporting periods beginning January 1, 2012. The first set of quality measures were publicly reported on Physician Compare in February 2014. A complete history of public reporting on Physician Compare is detailed in the CY 2016 PFS final rule (80 FR 71117 through 71122). The Physician Compare Initiative Web site at
As finalized in the CY 2015 and CY 2016 PFS final rules (79 FR 67547 and 80 FR 70885, respectively), Physician Compare will continue to expand public reporting. This expansion includes publicly reporting both individual eligible professional (now referred to as eligible clinician) and group-level QCDR measures starting with 2016 data available for public reporting in late 2017, as well as the inclusion of a 5-star rating based on a benchmark in late 2017 based on 2016 data (80 FR 71125 and 71129), among other additions.
This expansion will continue under the MACRA. Sections 1848(q)(9)(A) and (D) of the Act facilitate the continuation of our 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 group 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 clinicians 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 clinicians and the range of the performance of all MIPS eligible clinicians for each performance category.
Initial plans to publicly report this performance information on Physician Compare were finalized in the CY 2017 Quality Payment Program final rule (81 FR 77390). The proposals related to each of these requirements for year 2 of the Quality Payment Program are summarized below in this section.
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 sections 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, we have established a policy that, as determined through user testing, the data we disclose generally should resonate with and be accurately interpreted by Web site users 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 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, the Technical Expert Panel convened by our Physician Compare support team contractor, etc.).
In addition, section 1848(q)(9)(C) of the Act requires the Secretary to provide an opportunity for 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 77392). Section 1848(q)(9)(C) of the Act also requires that eligible clinicians be able to submit corrections for the information to be made public with respect to the eligible clinician. We finalized a policy to continue the current Physician Compare 30-day preview period for MIPS eligible clinicians starting with data from the 2017 MIPS performance period, which will be available for public reporting in late 2018. Therefore, we finalized a 30-day preview period in advance of the publication of data on Physician Compare (81 FR 77392).
We will coordinate data review and any relevant data resubmission or correction between Physician Compare and the four performance categories of MIPS. All data available for public reporting—measure rates, scores, and attestations, etc.—are available for review and correction during the targeted review process, which will begin at least 30 days in advance of the publication of new data. Data under review is not publicly reported until the review is complete. All corrected measure rates, scores, and attestations submitted as part of this process are available for public reporting. The technical details of the process are communicated directly to affected eligible clinicians and groups and detailed outside of rulemaking with specifics made public on the Physician Compare Initiative page on
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, in an easily understandable format, information for physicians and, as appropriate, other eligible clinicians related to items and services furnished to people with Medicare, and to include, at a minimum:
• Information on the number of services furnished by the physician or other eligible clinician 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 is further 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.
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 proposed to revise the public reporting regulation at § 414.1395(a) to more completely and accurately reference the data available for public reporting on Physician Compare and to remove from the heading and text references to “MIPS” and “public Web site” and instead reference “Quality Payment Program” and “Physician Compare”. Specifically, we proposed to modify § 414.1395(a) to read as follows: “Public reporting of eligible clinician and group Quality Payment Program information. For each program year, CMS posts on Physician Compare, in an easily understandable format, information regarding the performance of eligible clinicians or groups under the Quality Payment Program.” We also proposed to add paragraphs (b), (c), and (d) at § 414.1395, to capture previously established policies for Physician Compare relating to the public reporting standards, first year measures, and the 30-day preview period. Specifically, at § 414.1395(b), we proposed that, with the exception of data that must be mandatorily reported on Physician Compare, for each program year, we rely on the established public reporting standards to guide the information available for inclusion on Physician Compare. The public reporting standards require data included on Physician Compare to be statistically valid, reliable, and accurate; be comparable across submission mechanisms; and, meet the reliability threshold. And, to be included on the public facing profile pages, the data must also resonate with Web site users, as determined by CMS. At § 414.1395(c), we proposed to codify our policy regarding first year measures to state that for each program year, CMS does not publicly report any first year measure, meaning any measure in its first year of use in the quality and cost performance categories. After the first year, CMS reevaluates measures to determine when and if they are suitable for public reporting. At § 414.1395(d), we proposed to specify the 30-day preview period to state that for each program year, CMS provides a 30-day preview period for any clinician or group with Quality Payment Program data before the data are publicly reported on Physician Compare.
The following is a summary of the public comments received on the proposed changes and additions to the regulation text at § 414.1395(a) through § 414.1395(d) and our responses:
Concerning the commenters support for not including first year quality and cost measures, we understand the request to further delay measures, but as we discuss in more detail later in this final rule with comment period, we do not find added value in waiting to provide the public with potentially valuable information after clinicians and groups have had a chance to review and understand the initial results and the measure is deemed to meet all public reporting criteria. We believe the benefit of releasing the data in a timely manner is significant, especially for the more established quality data. We will carefully evaluate the cost measure data after the first year, understanding this is new and complex information. With the exception of data that must be mandatorily reported on Physician Compare, if certain cost measure data is determined under our established public reporting standards not to be suitable for public reporting, it will not be reported. Also, as discussed in greater detail in this final rule with comment period, we will proceed with our phased approach to public reporting, addressing requests to move forward with public reporting gradually.
Concerning the support for our 30-day preview period, we do understand the concerns raised about having ample time to review and contest data, if needed, but we do not believe a longer preview period is necessary. Historically, clinicians and groups have not initiated the preview process until near the end of the process, so we do not think that extending the preview period will provide additional value. We are actively working to ensure the preview process is more streamlined and user-friendly under the Quality Payment Program, which should also facilitate more easily obtaining the information needed to assist with previewing data. In addition, we are actively working to provide more information about the preview timeline and process each year through stakeholder outreach and the Physician Compare listserv. In light of these efforts, we believe the 30-day preview period is sufficient.
We believe section 10331 of the Affordable Care Act supports the overarching goals of the MACRA by providing the public 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 such, we proposed the
Sections 1848(q)(9)(A) and (D) of the Act require that we publicly report on Physician Compare the final score for each MIPS eligible clinician and the performance of each MIPS eligible clinician for each performance category, and that we 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 finalized such data for public reporting on Physician Compare for the transition year (81 FR 77393), and we proposed to add these data each year to Physician Compare for each MIPS eligible clinician or group, either on the profile pages or in the downloadable database, as technically feasible (82 FR 30165 through 30166). We will use statistical testing and user testing, as well as consultation with the Physician Compare Technical Expert Panel convened by the Physician Compare support team contractor, to determine how and where these data are best reported on Physician Compare. As the MACRA requires that this information be available for public reporting on Physician Compare, we proposed to include it each year moving forward, as technically feasible. We requested comment on this proposal to publicly report on Physician Compare the final score for each MIPS eligible clinician or group and the performance of each MIPS eligible clinician or group for each performance category, and to periodically post aggregate information on the MIPS, including the range of final scores for and the range of performance of all the MIPS eligible clinicians or groups for each performance category, as technically feasible.
The following is a summary of the public comments received on the “Final Score, Performance Categories, and Aggregate Information” proposals and our responses:
A summary of the proposals related to each performance category of MIPS data follows.
As detailed in the CY 2017 Quality Payment Program final rule (81 FR 77395), and consistent with the existing policy making all current PQRS measures available for public reporting, we finalized a decision to make all measures under the MIPS quality performance category available for public reporting on Physician Compare in the transition year of the Quality Payment Program, as technically feasible. This included all available measures reported via all available submission methods, and applied 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 public-facing Web site profile pages. As explained in the CY 2017 Quality Payment Program final rule (81 FR 77394), providing too much information can overwhelm Web site users and lead to poor decision making. Therefore, consistent with section 1848(q)(9)(A)(i)(II) of the Act, all measures in the quality performance category that meet the statistical public reporting standards will be included in the downloadable database, as technically feasible. We also finalized a policy that a subset of these measures will be publicly reported on the Web site's profile pages, as technically feasible, based on Web site user testing. We will use statistical testing and user testing to determine how and where measures are reported on Physician Compare. In addition, we adopted 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 method used, for the MIPS quality performance category. After a measure's first year in use, we will evaluate the measure to see if and when the measure is suitable for public reporting (81 FR 77395).
Currently, there is a minimum sample size requirement of 20 patients for performance data to be included on Physician Compare. In the CY 2017 Quality Payment Program final rule, we finalized instituting a minimum reliability threshold for public reporting data on Physician Compare starting with 2017 data available for public report in late 2018 and each year moving forward (81 FR 77395).
We will conduct analyses to determine the reliability of the data collected and use this to calculate the minimum reliability threshold for the data. Once an appropriate minimum reliability threshold is determined, we will only publicly report those performance rates for any given measure that meet the minimum reliability threshold. We note that reliability standards for public reporting and reliability for scoring need not align; reliability for public reporting is unique because, for example, public reporting requires ensuring additional protections to maintain confidentiality. In addition, because publicly reported measures can be compared across clinicians and across groups, it is particularly important for the most stringent reliability standards to be in place to ensure differences in performance scores reflect true differences in quality of care to promote accurate comparisons by the public. For further information on reliability as it relates to scoring of cost measures see section II.C.7.a.(3) of this final rule with comment period.
In the CY 2017 Quality Payment Program final rule, we established that we will include the total number of patients reported on each measure in the downloadable database to facilitate transparency and more accurate understanding and use of the data (81 FR 77395). We will begin publishing the total number of patients reported on each measure in the downloadable database with 2017 data available for public reporting in late 2018 and for each year moving forward.
Understanding that we will continue our policies to not publicly report first year quality measures, that we will only report those measures that meet the reliability threshold and meet the public reporting standards, and include the total number of patients reported on for each measure in the downloadable database, we again proposed to make all
The following is a summary of the public comments received on the “Quality” proposals and our responses:
We sought comment on expanding the patient experience data available for public reporting on Physician Compare. Currently, the CAHPS for MIPS survey is available for groups to report under the MIPS. This patient experience survey data is highly valued by patients and their caregivers as they evaluate their health care options. However, in testing with patient and caregivers, they regularly ask for more information from patients like them in their own words. Patients regularly request that we include narrative reviews of clinicians and groups on the Web site. The Agency for Healthcare Research and Quality (AHRQ) is fielding a beta version of the CAHPS Patient Narrative Elicitation Protocol (
We received a number of comments on this item and appreciate the input received. As this was a request for comment only, we will take the feedback provided into consideration for possible inclusion in future rulemaking.
Consistent with section 1848(q)(9)(A)(i)(II) of the Act, we finalized in the CY 2017 Quality Payment Program final rule a decision to make all measures under the MIPS cost performance category available for public reporting on Physician Compare (81 FR 77396). This included all available measures reported via all available submission methods, and applied to both MIPS eligible clinicians and groups. However, as noted in the final rule, we may not have data available for public reporting in the transition year of the Quality Payment Program for the cost performance category (2017 data available for public reporting in late 2018).
As discussed in the final rule (81 FR 77395), cost data are difficult for patients to understand, and, as a result, publicly reporting these measures could lead to significant misinterpretation and misunderstanding. For this reason, we again proposed to include on Physician Compare a subset of cost measures that meet the public reporting standards, either on profile pages or in the downloadable database, if technically feasible, for 2018 data available for public reporting in late 2019, and for each year moving forward (82 FR 30167).
These data are required by the MACRA to be available for public
The following is a summary of the public comments received on the “Cost” proposal and our responses:
We agree it is best to continue to not report first year cost measures, but as with quality measures, we believe that delaying consideration for inclusion if all public reporting criteria are met beyond the first year could unnecessarily prevent us from including valuable, timely information on the Web site. Through the rulemaking process, which provides an opportunity to comment on the universe of cost measures available for public reporting, and through stakeholder outreach and the 30-day preview period, we will provide ample opportunity for stakeholders to review the available data and provide feedback.
We will take the recommendation to link quality and cost data under consideration and evaluate feasibility for including this in future rulemaking.
Consistent with section 1848(q)(9)(A)(i)(II) of the Act, we finalized a decision to make all activities under the MIPS improvement activities performance category available for public reporting on Physician Compare (81 FR 77396). This included all available improvement activities reported via all available submission methods, and applied to both MIPS eligible clinicians and groups.
Consistent with the policy finalized for the transition year, we again proposed to include a subset of improvement activities data on Physician Compare that meet the public reporting standards, either on the profile pages or in the downloadable database, if technically feasible, for 2018 data available for public reporting in late 2019, and for each year moving forward (82 FR 30167). This again includes all available activities reported via all available submission methods, and applies to both MIPS eligible clinicians and groups. For those eligible clinicians or groups that successfully meet the improvement activities performance category requirements, this information will be posted on Physician Compare as an indicator. This information is required by the MACRA to be available for public reporting on Physician Compare, but the improvement activities performance category is a new field of data for Physician Compare, so concept and Web site user testing is still needed to ensure these data are understood by stakeholders. Therefore, we again proposed that we would use statistical testing and user testing to determine how and where improvement activities are reported on Physician Compare, as appropriate.
For the transition year, we excluded first year activities from public reporting (81 FR 77396). First year activities are any improvement activities in their first year of use. Starting with year 2 (2018 data available for public reporting in late 2019), we proposed publicly reporting first year activities if all other public reporting criteria are satisfied. This evolution in our Quality Payment Program public reporting plan provides an opportunity to make more valuable information public given that completion of or participation in first year activities is different from reporting first year quality or cost measures. Clinicians and groups can learn from the first year of quality and cost data, understand why their performance rate is what it is, and take time to improve. A waiting period for indicating completion or participation in an improvement activity is unlikely to produce the same benefit. We requested comments on these proposals.
The following is a summary of the public comments received on the “Improvement Activities” proposals and our responses:
We are also finalizing our proposal, for year 2 of the Quality Payment Program (2018 data available for public reporting in late 2019) and future years, to publicly reporting first year activities if all other public reporting criteria are satisfied.
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 (80 FR 62901), 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. At this time there is only an indicator on Physician Compare profile pages to show that an eligible clinician successfully participated in the current Medicare EHR Incentive Program.
As MIPS will include advancing care information as one of the four MIPS performance categories, we decided, consistent with section 1848(q)(9)(i)(II) of the Act, to include more information on an eligible clinician's or group's performance on the objectives and measures of meaningful use on Physician Compare for the transition year (81 FR 77387). An important consideration was that to meet the public reporting standards, the data added to Physician Compare must resonate with Medicare patients and their caregivers. 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 and groups who achieve high performance in key care coordination and patient engagement activities provide significant value for patients and their caregivers as they make health care decisions.
Consistent with our transition year final policy, and understanding the value of this information to Web site users, we again proposed to include an indicator on Physician Compare for any eligible clinician or group who successfully meets the advancing care information performance category, as technically feasible (82 FR 30168). Also, as technically feasible, we proposed to include additional indicators, including but not limited to, objectives, activities, or measures specified in section II.C.6.f. of the proposed rule (see 82 FR 30057 through 30080), such as identifying if the eligible clinician or group scores high performance in patient access, care coordination and patient engagement, or health information exchange. The proposals applied to 2018 data available for public reporting in late 2019, and for each year moving forward, as this information is required by the MACRA to be available for public reporting on Physician Compare. We also proposed that any advancing care information objectives, activities, or measures would need to meet the public reporting standards applicable to data posted on Physician Compare, either on the profile pages or in the downloadable database. This would include all available objectives, activities, or measures reported via all available submission methods, and would apply to both MIPS eligible clinicians and groups. We would use statistical testing and Web site user testing to determine how and where objectives and measures are reported on Physician Compare.
As with improvement activities, we also proposed to allow first year advancing care information objectives, activities, and measures to be available for public reporting starting in year 2 (2018 data available for public reporting in late 2019). Again, especially if we are including an indicator over a performance rate, the benefits of waiting 1 year are not the same and thus, we believe it is more important to make more information available for public reporting as the Quality Payment Program matures. We requested comment on these proposals.
The following is a summary of the public comments received on the “Advancing Care Information” proposals and our responses:
We are also finalizing our proposal that any advancing care information objectives, activities, or measures will need to meet the public reporting standards applicable to data posted on Physician Compare, either on the profile pages or in the downloadable database. This will include all available objectives, activities, or measures reported via all available submission methods, and will apply to both MIPS eligible clinicians and groups. We will use statistical testing and Web site user testing to determine how and where objectives, activities, and measures are reported on Physician Compare.
In addition, we are finalizing our proposal to allow first year advancing care information objectives, activities, and measures to be available for public reporting for year 2 of the Quality Payment Program (2018 data available for public reporting in late 2019) and future years, as appropriate.
Benchmarks are important to ensuring that the quality data published on Physician Compare are accurately understood. A benchmark allows Web site users to more easily evaluate the information published by providing a point of comparison between groups and between clinicians. In the CY 2016 PFS final rule (80 FR 71129), we finalized a decision to publicly report on Physician Compare an item, or measure-level, benchmark by submission mechanism, using the Achievable Benchmark of Care (ABC
We believe ABC
We finalized that the benchmark would be derived by calculating the total number of patients in the highest scoring subset receiving the intervention or the desired level of care, or achieving the desired outcome, and dividing this number by the total number of patients that were measured by the top performing doctors. This would produce a benchmark that represents the best care provided to the top 10 percent of patients by measure, by submission mechanism.
(1) We look at the total number of patients with diabetes for all clinicians who reported this diabetes measure.
(2) We rank clinicians that reported this diabetes measure from highest performance score to lowest performance score to identify the set of top clinicians who treated at least 10 percent of the total number of patients with diabetes.
(3) We count how many of the patients with diabetes who were treated by the top clinicians also got a foot exam.
(4) This number is divided by the total number of patients with diabetes who were treated by the top clinicians, producing the ABC
To account for low denominators, ABC
The benchmarks for Physician Compare developed using the ABC
During outreach, stakeholders expressed the importance of assigning star ratings in a way that is understandable to Web site users. The equal ranges method is intuitive to
After we determine the benchmark using the ABC
Clinicians or groups who meet or exceed the established benchmark for a measure will be assigned 5-stars. To determine the 4-star cut-off using the equal ranges method, we subtract the lowest performance score from the benchmark to get the range of performance scores, and then divide by 4 to get quarters. The 4-star cut-off is one quarter of the distance between the ABC
More information about this star attribution method can also be found on the Physician Compare Initiative page on cms.gov. As part of our phased approach to public reporting, we expect to publicly report the benchmark and 5-star rating for the first time on Physician Compare in late 2017 using the 2016 PQRS performance scores for a subset of available group-level measures.
As a result of stakeholder feedback asking that we consider one consistent approach for benchmarking and parsing the data based on the benchmark across the Quality Payment Program, we did consider an alternative approach. We reviewed the benchmark and decile breaks being used to assign points and determine payment under MIPS (see 82 FR 30168 through 30169). This approach was not considered ideal for public reporting for several reasons. A primary concern was that the decile approach when used for public reporting would force a star rating distribution inconsistent with the raw distribution of scores on a given measure. If applied to star ratings, there would need to be an equal distribution of clinicians in each of the star rating categories.
Using the ABC
It is not always ideal to use the same methodology across the program as scoring for payment purposes may be designed in a somewhat different way that may incorporate factors that are not necessarily as applicable for public reporting, while the key consideration for public reporting is that the methodology used best helps patients and caregivers easily interpret the data accurately. Testing with Web site users has shown that the star rating based on the ABC
ABC
We believe that displaying the appropriate and relevant MIPS data in this user-friendly format provides more opportunities to present these data to people with Medicare in a way that is most likely to be accurately understood and interpreted. We requested comment on these proposals.
The following is a summary of the public comments received on the “Achievable Benchmark of Care (ABC
We also appreciate the commenters' support for using the ABC
Regarding the commenters' concerns that not having clinicians broken out by subspecialty or not having more subspecialty specific measures means that some comparisons may not be appropriate with respect to certain subspecialties, we note that all searches on Physician Compare are by specialty and location. Therefore, there is some level of stratification by specialty for Web site users. We do appreciate the desire for more detailed specialty-level information. However, at this time, this level of detailed information—subspecialty information—is not available through the Provider Enrollment, Chain, and Ownership System (PECOS), the sole source of specialty information available to Physician Compare, and thus not available for use on Physician Compare. We will, however, continue to evaluate options for providing more sub-specialty level information for future consideration, as feasible.
In CY 2017 Quality Payment Program proposed rule (81 FR 28291), we solicited comment on the advisability and technical feasibility of including on Physician Compare data voluntarily reported by eligible clinicians and groups that are not subject to MIPS payment adjustments, such as excluded clinician types, to be addressed through separate notice-and-comment rulemaking.
As indicated in the CY 2017 Quality Payment Program final rule (81 FR 77394), comments received were favorable overall. Stakeholders generally support clinicians and groups being permitted to have data available for public reporting when submitting these data voluntarily under MIPS. As a result, we proposed starting with year 2 of the Quality Payment Program (2018 data available for public reporting in 2019) and for each year moving forward, to make available for public reporting all data submitted voluntarily across all MIPS performance categories, regardless of submission method, by eligible clinicians and groups that are not subject to the MIPS payment adjustments, as technically feasible (82 FR 30169).
If an eligible clinician or group that is not subject to the MIPS payment adjustments chooses to submit quality, cost (if applicable), improvement activity, or advancing care information, these data would become available for public reporting. However, because these data would be submitted voluntarily, we proposed that during the 30-day preview period, these eligible clinicians and groups would have the option to opt out of having their data publicly reported on Physician Compare. If eligible clinicians and groups do not take the action to opt out at this time, their data would be available for inclusion on Physician Compare if the data meet all previously stated public reporting standards and the minimum reliability threshold. As eligible clinicians and groups that are not required to report under MIPS, particularly in the first years of the Quality Payment Program, are taking additional steps to show their commitment to quality care, we want to ensure they have the opportunity to report their data and have it included on Physician Compare. We requested comment on the proposal.
The following is a summary of the public comments received on the “Voluntary Reporting” proposals and our responses:
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 to build on the ACO reporting we are now doing 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 participated in an ACO. Also, currently, all ACOs have a dedicated page on the Physician Compare Web site to showcase their data. For the transition year of the Quality Payment Program, we decided to use this model as a guide as we add APM data to Physician Compare. Specifically, we finalized a policy to indicate on eligible clinician and group profile pages of Physician Compare when the eligible clinician or group is participating in an APM (81 FR 77398). We also finalized a decision to link eligible clinicians and groups to their APM's data, as technically feasible, through Physician Compare. The finalized policy provides the opportunity to publicly report data for both Advanced APMs and APMs that are not considered Advanced APMs for the transition year, as technically feasible.
At the outset, APMs will be very new concepts for Medicare patients and their caregivers. In these early years, indicating who participated in APMs and testing language to accurately explain that to Web site users provides useful and valuable information as we continue to evolve Physician Compare. As we come to understand how to best explain this concept to patients and their caregivers, we can continue to assess how to most fully integrate these data on the Web site. Understanding this and understanding the value of adding APM data to Physician Compare, we again proposed to publicly report names of eligible clinicians in Advanced APMs and the names and performance of Advanced APMs and APMs that are not considered Advanced APMs related to the Quality Payment Program starting with year 2 (2018 data available for public reporting in late 2019), and for each year moving forward, as technically feasible (82 FR 30170). In addition, we again proposed to continue to find ways to more clearly link clinicians and groups and the APMs they participate in on Physician Compare, as technically feasible. We requested comment on the proposals.
The following is a summary of the public comments received on the “APM Data” proposals and our responses:
We understand that social risk factors such as income, education, race and ethnicity, employment, disability, community resources, and social support play a major role in health. One of our core objectives is to improve the outcomes of people with Medicare, and we want to ensure that complex patients, as well as those with social risk factors receive excellent care. In addition, we seek to ensure that all clinicians are treated as fairly as possible within all CMS programs. In the CY 2017 Quality Payment Program final rule (81 FR 77395), we noted that we would review the first of several reports by the Office of the Assistant Secretary for Planning and Evaluation (ASPE)
As we continue to consider the analyses and recommendations from these and any future reports, we look forward to working with stakeholders in this process. Therefore, we sought comment only on accounting for social risk factors through public reporting on Physician Compare (82 FR 30170). Specifically, we sought comment on stratified public reporting by risk factors and ask for feedback on which social risk factors or indicators should be used and from what sources. Examples of social risk factor indicators include but are not limited to dual eligibility/low-income subsidy, race and ethnicity, social support, and geographic area of residence. We also sought comment on the process for accessing or receiving the necessary data to facilitate stratified reporting. Finally, we sought comment on whether strategies such as confidential reporting of stratified rates using social risk factor indicators should be considered in the initial years of the Quality Payment Program in lieu of publicly reporting stratified performance rates for quality and cost measures under the MIPS on Physician Compare. We sought comment only on these items for possible consideration in future rulemaking.
The following is a summary of the public comments received on the “Stratification by Social Risk Factors” request for comment:
We received a number of comments on this item and appreciate the input received. As this was a request for comment only, we will take the feedback provided into consideration for possible inclusion in future rulemaking.
Finally, we proposed adding additional Board Certification information to the Physician Compare Web site (82 FR 30170). Board Certification is the process of reviewing and certifying the qualifications of a physician or other clinician by a board of specialists in the relevant field. We currently include American Board of Medical Specialties (ABMS), American Osteopathic Association (AOA), and American Board of Optometry (ABO) data as part of clinician profiles on Physician Compare. We appreciate that there are additional, well respected boards that are not included in the ABMS, AOA, and ABO data currently available on Physician Compare that represent clinicians and specialties included on the Web site. Such board certification information is of interest to users as it provides additional information to use to evaluate and distinguish between clinicians on the Web site, which can help in making an informed health care decision. The more data of immediate interest that is included on Physician Compare, the more users will come to the Web site and find data that can help them make informed decisions. Please note we are not endorsing any particular boards.
Another board, the American Board of Wound Medicine and Surgery (ABWMS), has shown interest in being added to Physician Compare and have demonstrated that they have the data to facilitate inclusion of this information on the Web site. We believe this board fills a gap for a specialty that is not currently covered by the ABMS, so we proposed to add ABWMS Board Certification information to Physician Compare.
Additionally, for all years moving forward, for any board that would like to be considered for addition to the Physician Compare Web site, we proposed to establish a process for reviewing interest from these boards as it is brought to our attention on a case-by-case basis, and selecting boards as possible sources of additional board certification information for Physician Compare. We further proposed that, for purposes of CMS's selection, the board would need to demonstrate that it: fills a gap in currently available board certification information listed on Physician Compare, can make the necessary data available, and, if appropriate, can make arrangements and enter into agreements to share the needed information for inclusion on Physician Compare. We proposed that boards contact the Physician Compare support team at
The following is a summary of the public comments received on the “Board Certification” proposals and our responses:
Section 1833(z) of the Act requires that an incentive payment be made to QPs for participation in Advanced APMs. In the CY 2017 Quality Payment Program final rule (81 FR 77399 through 77491), we finalized policies relating to the following topics:
• Beginning in 2019, if an eligible clinician participated sufficiently in an Advanced APM during the QP Performance Period, that eligible clinician may become a QP for the year. Eligible clinicians who are QPs are excluded from the MIPS reporting requirements for the performance year and payment adjustment for the payment year.
• 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. Beginning in 2026, QPs receive a higher update under the PFS for the year 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 (which we refer to as the All-Payer Combination Option).
In the CY 2018 Quality Payment Program proposed rule, we proposed clarifications and modifications to some of the policies that we previously finalized and provided additional details and proposals regarding the All-Payer Combination Option (82 FR 30170-30207). In this CY 2018 Quality Payment Program final rule with comment period, we respond to public comments on those proposals and announce our final policies.
In the CY 2018 Quality Payment Program proposed rule, we explained that as we continue to develop the Quality Payment Program, we identified the need to propose additions, deletions, and changes to some of the definitions previously finalized in our regulations at § 414.1305 (82 FR 30171).
In the CY 2018 Quality Payment Program proposed rule, we proposed to change the timeframe of the QP Performance Period under the All-Payer Combination Option so that it would begin on January 1 and end on June 30 of the calendar year that is 2 years prior to the payment year. We proposed to add the definition of All-Payer QP Performance Period using this timeframe. We also proposed to add the definition of Medicare QP Performance Period, which would begin on January 1 and end on August 31 of the calendar year that is 2 years prior to the payment year. We would replace the single definition we established in the CY 2017 Quality Payment Program final rule for QP Performance Period with the definitions of All-Payer QP Performance Period and Medicare QP Performance Period. To update the regulation to incorporate this proposal, we also proposed to remove “QP Performance Period” each time it occurs in our regulations and replace it with either “All-Payer QP Performance Period” or “Medicare QP Performance Period” as relevant (82 FR 30171).
We sought comment on these proposals. The following is a summary of the public comments received on these proposals and our responses:
As we discussed in the CY 2018 Quality Payment Program proposed rule, in connection with our proposals to calculate Threshold Scores for QP determinations under the All-Payer Combination Option, we did not anticipate having or receiving information about attributed beneficiaries as we do under the Medicare Option. This is because under the All-Payer Combination Option, APM Entities or eligible clinicians would only submit aggregate payment and patient data. We would not have anything similar to a Participation List or an Affiliated Practitioner List for Other Payer Advanced APMs. Therefore, we proposed to change the definition of attributed beneficiary so that it only applies to Advanced APMs, not to Other Payer Advanced APMs (82 FR 30171).
We sought comment on this proposal. The following is a summary of the public comments received on these proposals and our responses:
We sought comment on these terms, including how we have defined the terms, 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 we use 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 would consider options for a framework of definitions
The comments we received in response to this comment solicitation are discussed throughout this section as they are responsive to specific proposals regarding defined terms. We note that we may consider the creation of additional terms or revision of existing terms in future rulemaking.
In the CY 2018 Quality Payment Program proposed rule, we proposed to revise the definition of APM Entity in the regulation at § 414.1305 to clarify that a “payment arrangement with a non-Medicare payer” is an other payer arrangement as defined in § 414.1305. We proposed to make technical changes to the definition of Medicaid APM in § 414.1305 to clarify that these arrangements must meet the Other Payer Advanced APM criteria set forth in § 414.1420, and not just the criteria under § 414.1420(a) as provided under the definition finalized in the CY 2017 Quality Payment Program final rule.
To consolidate our regulations and avoid unnecessarily defining a term, we proposed to remove the defined term for Advanced APM Entity in § 414.1305 and to replace “Advanced APM Entity” where it appears throughout the regulations with “APM Entity.” We also proposed to make this substitution in the definitions of Affiliated Practitioner and Attributed Beneficiary in § 414.1305. Similarly, we proposed to replace “Advanced APM Entity group” with “APM Entity group” where it appears throughout our regulations. We noted that these proposed changes are technical and would not have a substantive effect on our policies.
We sought comment on these proposals. The following is a summary of the public comments received on these proposals and our responses:
We proposed technical changes to correct the references in the first sentence of the regulation at § 414.1415 to refer to the financial risk standard under paragraph (c)(1) or (2) and the nominal amount standard under paragraph (c)(3) or (4). Due to typographical errors, the regulation finalized in the CY 2017 Quality Payment Program final rule refers to paragraphs (d)(1) through (4), and there is no paragraph (d) in this section. We also proposed to correct typographical errors in § 414.1420(a)(3)(i), (a)(3)(ii), (d) and (d)(1). In § 414.1420(d), we proposed to correct the reference to the “nominal risk standard” to instead refer to the “nominal amount standard.” We proposed technical, non-substantive clarifications in §§ 414.1425(a)(1) through (3), and (b)(2); and § 414.1435(d). We also proposed to correct a typographical error in § 414.1460(b) to refer to participation “during a QP Performance Period” instead of “during the QP Performance Periods.”
We sought comment on these proposals. We received no comments in response to these proposals.
In the CY 2018 Quality Payment Program proposed rule, we proposed to reorganize and revise the monitoring and program integrity provisions at § 414.1460. We proposed changes to paragraphs (a), (b), and (d) in this section of the proposed rule as these policies apply to both the Medicare Option and the All-Payer Combination Option. We explained that we addressed the changes we proposed to paragraphs (c) and (e) of § 414.1460 in our discussion of the All-Payer Combination Option (82 FR 30195).
We finalized in the CY 2017 Quality Payment Program final rule at § 414.1460(d) that for any QPs who are terminated from an Advanced APM or found to be in violation of any Federal, State, or tribal statute, regulation, or binding guidance during the QP Performance Period or Incentive Payment Base Period or terminated after these periods as a result of a violation occurring during either period, we may rescind such eligible clinician's QP determinations and, if necessary, recoup part or all of any such eligible clinician's APM Incentive Payment or deduct such amount from future payments to such individuals. We also finalized that we may reopen and recoup any payments that were made in error (81 FR 77555).
In the CY 2018 Quality Payment Program proposed rule, we acknowledged that rescinding QP determinations and reopening and recouping APM Incentive Payments are separate policies. For this reason, we proposed to reorganize § 414.1460 so that paragraph (b) sets forth our policy on rescinding QP determinations and paragraph (d) sets forth our policy on reopening and recouping APM Incentive Payments. We proposed to revise § 414.1460(b) to specify when we may rescind a QP determination. In addition, we proposed to remove the last sentence of § 414.1460(d), which provides that an APM Incentive Payment would be recouped if an audit reveals a lack of support for attested statements provided by eligible clinicians and APM Entities. We explained that we believe that this provision is duplicative of the immediately preceding sentence, which permits us to reopen and recoup any erroneous payments in accordance with existing procedures set forth at §§ 405.980 through 405.986 and §§ 405.370 through 405.379. We proposed to codify our recoupment policy at § 414.1460(d)(2), which provides that we may reopen, revise, and recoup an APM Incentive Payment that was made in error in accordance with procedures similar to those set forth at §§ 405.980 through 405.986 and §§ 405.370 through 405.379 or as established under the relevant APM.
In the CY 2017 Quality Payment Program final rule, we indicated at § 414.1460(b) that we may reduce or deny an APM Incentive Payment to eligible clinicians who are terminated by APMs or whose APM Entities are terminated by APMs for non-compliance with Medicare conditions of participation or the terms of the relevant Advanced APMs in which they
The following is a summary of the public comments received on these proposed changes to § 414.1460 and our responses:
In the CY 2017 Quality Payment Program final rule, we finalized the criteria that define an Advanced APM based on the requirements set forth in sections 1833(z)(3)(C) and (D) of the Act (81 FR 77408). An Advanced APM is an APM that:
• Requires its participants to use certified EHR technology (CEHRT) (81 FR 77409-44414);
• Provides for payment for covered professional services based on quality measures comparable to measures under the quality performance category under MIPS (81 FR 77414-77418); and
• Either requires its participating APM Entities to bear financial risk for monetary losses that are in excess of a nominal amount, or the APM is a Medical Home Model expanded under section 1115A(c) of the Act (81 FR 77418-77431). We refer to this criterion as the financial risk criterion.
We proposed the following changes and modifications to aspects of the financial risk criterion in the CY 2018 Quality Payment Program proposed rule:
• We proposed to amend § 414.1415(c)(2) to exempt any APM Entities in Round 1 of the Comprehensive Primary Care Plus (CPC+) Model as of January 1, 2017 from the requirement that, beginning in the 2018 QP Performance Period, the Medical Home Model financial risk standard applies only to an APM Entity that is participating in a Medical Home Model if it has fewer than 50 eligible clinicians in its parent organization (82 FR 30172-30173).
• We proposed to amend § 414.1415(c)(3)(i)(A) and (c)(4)(i)(A) through (D) to more clearly define the generally applicable revenue-based nominal amount standard and the Medical Home Model revenue-based nominal amount standard as a percentage of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities (82 FR 30173).
• We proposed to amend § 414.1415(c)(3)(i)(A) to state that the generally applicable revenue-based nominal amount standard remains at 8 percent of the average estimated total Medicare Parts A and B revenue of providers and suppliers in participating APM Entities for the 2019 and 2020 QP Performance Periods, and to address the standard for QP Performance Periods after 2020 through subsequent rulemaking (82 FR 30173-30174).
• We proposed to amend § 414.1415(c)(4)(i)(A) through (D) to provide that, to be an Advanced APM, a Medical Home Model must require that the total annual amount that an APM Entity potentially owes us or foregoes under the Medical Home Model be at least the following amounts:
++ For QP Performance Period 2018, 2 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
++ For QP Performance Period 2019, 3 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
++ For QP Performance Period 2020, 4 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
++ For QP Performance Periods 2021 and later, 5 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities (82 FR 30174).
In the CY 2017 Quality Payment Program final rule, we finalized that beginning in the 2018 QP Performance Period, the Medical Home Model financial risk and nominal amount standards would only apply to APM Entities that participate in Medical Home Models and that have fewer than 50 eligible clinicians in the organization through which the APM Entity is owned and operated (81 FR 77430). We refer to this policy throughout this final rule with comment period as the 50 eligible clinician limit. Under this policy, the Medical Home Model financial risk and nominal amount standards would be applicable only for those APM Entities owned and operated by organizations with fewer than 50 eligible clinicians. We note this policy does not apply to Medical Home Models expanded under section 1115A of the Act.
In the CY 2018 Quality Payment Program proposed rule, we stated that we finalized the 50 eligible clinician limit after practices applied and signed agreements with CMS to participate in Round 1 of the CPC+ Model. As such, practices applying to participate in Round 1 of the CPC+ Model were not necessarily aware of the eligible clinician limit policy and, by the beginning of 2018, will have already participated in the CPC+ Model for one year without this requirement applying to them. Thus, to permit continued and uninterrupted testing of the CPC+ Model in existing regions, we stated that we believe it is necessary to exempt practices participating in Round 1 of the CPC+ Model from this requirement. Additionally, we noted that because in the future all APM Entities would know about this requirement prior to their enrollment, and in order to ensure that large APM Entities that are able to bear more risk enroll in models with higher levels of risk, we proposed that CPC+ Model participants who enroll in the future (for example, in Round 2 of the CPC+ Model) would not be exempt from this requirement (82 FR 30172-30173).
Therefore, we proposed to amend § 414.1415(c)(2) to exempt any APM Entity participating in Round 1 of the CPC+ Model from the requirement that beginning in the 2018 QP Performance Period, the Medical Home Model financial risk standard applies only to an APM Entity that is participating in a Medical Home Model if it has fewer than 50 eligible clinicians in its parent organization. We sought comment on this proposal.
The following is a summary of the public comments received on this proposal and our responses:
Many commenters requested that CMS remove the 50 eligible clinician limit for all Medical Home Models, not just exempt those practices in Round 1 of the CPC+ Model. These commenters suggested that the 50 eligible clinician limit is arbitrary and expressed concern that it may exclude clinicians and practices who could benefit most from the Medical Home Model financial risk and nominal amount standards. Some of these commenters also expressed concern that the 50 eligible clinician limit could discourage larger group or multispecialty practices from participating in in Medical Home Models, which could limit access for beneficiaries to primary care medical home services. The commenters noted that many health care providers associated with large group or multispecialty practices are well positioned to deliver primary care medical home services, but they might be discouraged from participating because they would exceed the 50 eligible clinician limit. Some of the commenters who opposed applying the 50 eligible clinician limit to any Medical Home Model expressed concern that the limit could distort market dynamics and have unintended consequences. These commenters also suggested the 50 eligible clinician limit reflects a preference for larger practices to participate in ACOs instead of Medical Home Models, which the commenters disagreed with.
As we discussed in the CY 2017 Quality Payment Program final rule, the 50 eligible clinician limit was intended to encourage larger organizations to move into Advanced APMs with greater levels of risk. We did not intend to imply that participation in Medical Home Models is necessarily inappropriate for larger organizations; and we recognize that Medical Home Models differ from other APMs, such as ACO initiatives, in that Medical Home Models focus on improving primary care through much more targeted interventions than those commonly found in other APMs. We encourage organizations that can effectively participate in Medical Home Models to do so, regardless of whether that participation results in the participating eligible clinicians in the APM Entity becoming QPs in a given year (81 FR 77429). However, we believe it is appropriate for larger organizations that exceed the 50 eligible clinician limit to assume risk that meets the generally applicable financial risk and nominal amount standards, commensurate with their capability, in order for their participation in a Medical Home Model to be treated as participation in an Advanced APM for purposes of QP determinations.
We are also making accompanying edits to our discussion of the 50 eligible clinician limit for Medicaid Medical Home Models by amending §§ 414.1420(d)(2) and § 414.1415(d)(4) and adding § 414.1420(d)(8).
In the CY 2017 Quality Payment Program final rule, we finalized two generally applicable standards for defining what is a nominal amount of risk—a benchmark-based standard and a revenue-based standard. We also finalized an alternative nominal amount standard applicable only to Medical Home Models. Both the generally applicable revenue-based nominal amount standard and the Medical Home Model revenue-based nominal amount standards state the standard in terms of average estimated total Medicare Parts A and B revenue of participating APM Entities (81 FR 77424).
In the CY 2018 Quality Payment Program proposed rule, we acknowledged that this language may be ambiguous as to whether it is intended to include payments to all providers and suppliers in an APM Entity or only payments directly to the APM Entity itself. To eliminate this potential ambiguity, we proposed to amend §§ 414.1415(c)(3)(i)(A) and (c)(4)(i)(A) through (D) to more clearly define the generally applicable revenue-based nominal amount standard and the Medical Home Model revenue-based nominal amount standard as a percentage of the average estimated total Medicare Parts A and B revenue of providers and suppliers in participating APM Entities. Under the proposed policy, when assessing whether an APM meets the generally applicable revenue-based nominal amount standard, where total risk under the model is not expressly defined in terms of revenue, we would calculate the estimated total Medicare Parts A and B revenue of providers and suppliers that are at risk for each APM Entity. We would then calculate an average of all the estimated total Medicare Parts A and B revenue of providers and suppliers that are at risk for each APM Entity, and if that average estimated total Medicare Part A and B revenue that is at risk for all APM Entities was equal to or greater than 8 percent, the APM would satisfy the generally applicable revenue-based nominal amount standard (82 FR 30173). The same approach would be taken for assessing whether a Medical Home Model meets the Medical Home Model nominal amount standard.
We requested comment on this proposal.
The following is a summary of the public comments received on this proposal and our responses:
We also note that, for APMs that expressly limit total risk in terms of revenue, we do not assess whether an APM meets the generally applicable revenue-based nominal amount standard based on the percentage of average estimated total Medicare Parts A and B revenue of providers and suppliers in participating APM Entities. For example, the Medicare ACO Track 1+ Model expressly caps risk for certain ACOs in terms of participant revenue). For these APMs, if the amount of total risk, in terms of revenue, required under the terms of the APM is equal to or greater than 8 percent, then the APM would meet the revenue-based nominal amount standard.
We also disagree that including Part A revenues would discourage collaboration between physicians and hospitals. While APM Entities that include both physicians and hospitals may, depending on an individual APM's design, be exposed to greater risk, they would also presumably have greater capacity to assume this risk and may also have greater capacity to manage their beneficiaries across the spectrum of care.
In the CY 2017 Quality Payment Program final rule, we finalized the amount of the generally applicable revenue-based nominal amount standard at 8 percent for the first two QP Performance Periods only, and we sought comment on what the revenue-based nominal amount standard should be for the third and subsequent QP Performance Periods. Specifically, we sought 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 (81 FR 77427).
After considering public comments submitted on the potential options for increasing the generally applicable revenue-based nominal amount standard for 2019 QP Performance Period and later, in the CY 2018 Quality Payment Program proposed rule, we proposed to maintain the current generally applicable revenue-based nominal amount standard at 8 percent of the average estimated total Medicare Part A and B revenue of all providers and suppliers in participating APM Entities for the 2019 and 2020 QP Performance Periods, and to address the standard for QP Performance Periods after 2020 through subsequent rulemaking (82 FR 30173).
We sought comment on this proposal.
The following is a summary of the public comments received on this proposal and our responses:
One commenter stated that in the CY 2017 Quality Payment Program final rule, CMS used discretionary authority to establish a different Medical Home Model financial risk standard and lower level of risk in the Medical Home Model nominal amount standard. This commenter suggested that CMS use the same discretionary authority to establish a more gradual progression of financial risk for Advanced APMs in general.
We also note that establishing a more gradual progression of financial risk required for purposes of deciding whether an APM to be considered is an Advanced APM would not reduce the level of risk under any particular APM, nor would it likely change the list of Advanced APMs in 2018.
We also sought comment on whether we should consider either a lower or higher revenue-based nominal amount standard for the 2019 and 2020 QP Performance Periods, and we sought comment on the amount and structure of the revenue-based nominal amount standard for QP Performance Periods 2021 and later. In particular, we sought comment on whether we should consider a different, potentially lower, revenue-based nominal amount standard only for small practices and those in rural areas (82 FR 30173-30174).
The following is a summary of the public comments received in response to our request for comment and our responses:
In the CY 2017 Quality Payment Program final rule, we finalized that for a Medical Home Model to be an Advanced APM, the total annual amount that an APM Entity potentially owes CMS or foregoes must be at least:
• For QP Performance Period 2017, 2.5 percent of the estimated average total Medicare Parts A and B revenues of participating APM entities.
• For QP Performance Period 2018, 3 percent of the estimated average total Medicare Parts A and B revenues of participating APM entities.
• For QP Performance Period 2019, 4 percent of the estimated average total Medicare Parts A and B revenues of participating APM entities.
• For QP Performance Period 2020 and later, 5 percent of the estimated average total Medicare Parts A and B revenues of participating APM entities (81 FR 77428).
In the CY 2018 Quality Payment Program proposed rule, we reconsidered this schedule for incremental annual increases in the nominal amount standard that we finalized for Medical Home Models. We acknowledged that establishing an even more gradual increase in risk for Medical Home Models with a lower risk floor for the 2018 QP Performance Period may be better suited to the circumstances of many APM Entities in Medical Home Models that have little experience with risk. We also reiterated, as we noted 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 merely sets a floor on the level of risk required for the APM to be considered an Advanced APM. To that end, we noted that we believe a small reduction of risk in the Medical Home Model nominal amount standard beginning in the 2018 QP Performance Period, along with a more gradual progression toward a 5 percent nominal amount standard, would allow for greater flexibility at the APM level in setting financial risk thresholds that would encourage more participation in Medical Home Models and be more sustainable for the type of APM Entities that would potentially participate in Medical Home Models (82 FR 30174).
Therefore, we proposed that to be an Advanced APM, a Medical Home Model must require that the total annual amount that an APM Entity potentially owes CMS or foregoes under the Medical Home Model be at least the following:
• For QP Performance Period 2018, 2 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
• For QP Performance Period 2019, 3 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
• For QP Performance Period 2020, 4 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
• For QP Performance Periods 2021 and later, 5 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
We sought comment on this proposal.
The following is a summary of the public comments received on this proposal and our responses:
We also reiterate that, as described in the CY 2017 Quality Payment Program final rule, a Medical Home Model that has been expanded under section 1115A(c) of the Act would meet the expanded Medical Home Model criterion under section 1833(z)(3)(D)(ii)(II) of the Act, and thus would not need to meet the financial risk criterion under section 1833(z)(3)(D)(ii)(I) of the Act in order to be an Advanced APM. Under this policy, an APM would have to be both determined to be a Medical Home Model and in fact be expanded using the authority under section 1115A(c) of the Act in order to be an Advanced APM without considering the financial risk and nominal amount standards (81 FR 77431).
Lastly, we disagree with commenters that costs not encompassed by an APM's financial risk arrangements should be considered when assessing financial risk under the APM. For a more extensive discussion of this issue, we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77420; 81 FR 77467).
In addition, many APMs that have ACOs as the APM Entities use beneficiary attribution or alignment methodologies that rely on determining where a beneficiary received the plurality of evaluation and management services, which are often furnished by primary care practitioners. This creates an incentive for larger organizations such as health systems and multi-specialty group practices that join to form ACOs to include primary care providers in the ACO in order to maintain adequate patient attribution.
We are finalizing in § 414.1415(c)(4)(i)(B) through (E) that to be an Advanced APM, a Medical Home Model must require that the total annual amount that an APM Entity potentially owes us or foregoes under the Medical Home Model be at least the following:
• For QP Performance Period 2018, 2.5 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
• For QP Performance Period 2019, 3 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
• For QP Performance Period 2020, 4 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
• For QP Performance Periods 2021 and later, 5 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
In summary, we are finalizing the following policies:
• We are finalizing our proposal to exempt any APM Entities in Round 1 of the Comprehensive Primary Care Plus (CPC+) Model, which is a Medical Home Model as of January 1, 2017 from the requirement that, beginning in the 2018 QP Performance Period, the Medical Home Model financial risk standard applies only to an APM Entity that is participating in a Medical Home Model if it has fewer than 50 eligible clinicians in its parent organization by amending § 414.1415(c)(2) and adding § 414.1415(c)(7). We are also making accompanying edits to our discussion of the 50 eligible clinician limit in Medicaid Medical Home Models at § 414.1420(d)(2), § 414.1415(d)(4), and adding § 414.1420(d)(8).
• We are amending § 414.1415(c)(3)(i)(A) and (c)(4)(i)(A) through (E) as proposed to more clearly define the generally applicable revenue-
• We are amending § 414.1415(c)(3)(i)(A) to state that the generally applicable revenue-based nominal amount standard remains at 8 percent of the average estimated total Medicare Parts A and B revenue of providers and suppliers in participating APM Entities for the 2019 and 2020 QP Performance Periods. We will address the standard for QP Performance Periods after 2020 through subsequent rulemaking.
• We are amending § 414.1415(c)(4)(i)(B) through (E) to provide that, to be an Advanced APM, a Medical Home Model must require that the total annual amount that an APM Entity potentially owes CMS or foregoes under the Medical Home Model be at least the following amounts:
++ For QP Performance Period 2018, 2.5 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
++ For QP Performance Period 2019, 3 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
++ For QP Performance Period 2020, 4 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
++ For QP Performance Period 2021 and later, 5 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
We finalized policies relating to QP and Partial QP determinations in the CY 2017 Quality Payment Program final rule (81 FR 77433-77450). We finalized that the QP Performance Period will run from January 1 through August 31 of the calendar year that is 2 years prior to the payment year (81 FR 77446). In the CY 2018 Quality Payment Program proposed rule, we proposed to refer to this time period for the Medicare Option as the Medicare QP Performance Period (82 FR 30171). As we discuss in sections II.D.6.d.(3)(a) and II.D.6.d.(3)(b) of this final rule with comment period, we are not finalizing the term Medicare QP Performance Period.
Because some Advanced APMs may start or end during a QP Performance Period, we proposed the following in the CY 2018 Quality Payment Program proposed rule:
• We proposed to calculate QP Threshold Scores for APM Entities in Advanced APMs that are actively tested continuously for a minimum of 60 days during the QP Performance Period and start or end during the QP Performance Period using only the dates that APM Entities were able to participate in active testing in the Advanced APM per the terms of the Advanced APM, not the full QP Performance Period. We proposed to add this policy to § 414.1425(c)(6) (82 FR 30175).
• We proposed to make QP determinations under § 414.1425(c)(4), for eligible clinicians participating in multiple Advanced APMs using the full QP Performance Period even if the eligible clinician participates in one or more Advanced APMs that start or end during the QP Performance Period (82 FR 30175 through 30176).
• We proposed to amend our regulations to make clear that under § 414.1425(c)(4), if an eligible clinician is determined to be a QP based on participation in multiple Advanced APMs, but any of the APM Entities in which the eligible clinician participates voluntarily or involuntarily terminates from the Advanced APM before the end of the QP Performance Period, the eligible clinician is not a QP (82 FR 30176).
We acknowledged in the CY 2018 Quality Payment Program proposed rule that there may be Advanced APMs that start after January 1 of the QP Performance Period for a year and that there may also be Advanced APMs that end prior to the August 31 end of the QP Performance Period for a year (82 FR 30175). By “start” and “end,” in this context, we explained that we mean that the period of active testing of the model starts or ends such that there is no opportunity for any APM Entity to participate in the Advanced APM before it starts or to participate in it after it ends. We explained that we consider the active testing period to mean the dates within the performance period specific to the model, which is also the time period for which we consider payment amounts or patient counts through the Advanced APM when we make QP determinations. We explained that an Advanced APM is in active testing if APM Entities are furnishing services to beneficiaries and those services will count toward the APM Entity's performance in the Advanced APM. We proposed to modify our policies regarding the timeframe(s) for which payment amount and patient count data are included in the QP payment amount and patient count threshold calculations for Advanced APMs that start after January 1 or end before August 31 in a given QP Performance Period (82 FR 30175). In these situations, we would calculate QP Threshold Scores using only data in the numerator and denominator for the dates that APM Entities were able to participate in active testing of the Advanced APM, per the terms of the Advanced APM, so long as APM Entities were able to participate in the Advanced APM for 60 or more continuous days during the QP Performance Period. We proposed to add this policy to § 414.1425(c)(6) (82 FR 30175). The QP Threshold Score would be calculated at the APM Entity level or the Affiliated Practitioner level as set forth in § 414.1425(b); this change would not affect our established policy as to which list of eligible clinicians, the Participation List or Affiliated Practitioner List, would be used.
We sought comment on these proposals.
The following is a summary of the public comments received on these proposals and our responses:
We also proposed to make QP and Partial QP determinations for eligible clinicians who participate in multiple Advanced APMs as set forth by §§ 414.1425(c)(4) and 414.1425(d)(2) of our regulation using the full QP Performance Period even if the eligible clinician participates in one or more Advanced APMs that start or end during the QP Performance Period (82 FR 30175-30176).
We sought comment on this proposal.
The following is a summary of the public comments received on this proposal and our responses:
With the exception of QP determinations for individual eligible clinicians who participate in multiple Advanced APMs, we believe it is appropriate to require that an Advanced APM must be actively tested for a minimum of 60 continuous days during the QP Performance Period in order for the payment amount or patient count data to be considered for purposes of QP determinations for the year because it is important that the QP determination be based on a measure of meaningful participation in an Advanced APM.
Accordingly, we proposed to make QP determinations for all QP determination snapshot dates that fall after the Advanced APM meets the minimum time requirement of 60 continuous days whether the Advanced APM starts or ends during the QP Performance Period. We would not make a QP or Partial QP determination for participants in Advanced APMs that are not actively tested for a period of at least 60 continuous days during the Medicare QP Performance Period (82 FR 30176).
We sought comment on this proposal. We received no comments in response to this proposal.
In the CY 2018 Quality Payment Program proposed rule, we proposed to amend §§ 414.1425(c)(4) and (d)(4) to better reflect our intended policy for QP determinations and Partial QP determinations for eligible clinicians who are 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 those who are Affiliated Practitioners (82 FR 30176). As we explained in the CY 2017 Quality Payment Program final rule, eligible clinicians may become QPs through any of the assessments conducted for the three snapshot dates: March 31, June 30, and August 31 (81 FR 77446-77447). If the APM Entity group meets the QP threshold under this first assessment, then all eligible clinicians in the APM Entity group will be QPs unless the APM Entity's participation in the Advanced APM is voluntarily or involuntarily terminated before the end of the QP Performance Period, or in the event of a program integrity violation by eligible clinician or APM as set forth in § 414.1460. We stated these same procedures apply to the QP determination made for individual eligible clinicians on an APM Entity's Affiliated Practitioner List or individual eligible clinicians in multiple Advanced APMs whose APM Entity groups did not meet the QP threshold.
We also proposed to amend our regulations to make clear that under § 414.1425(c)(4), if an eligible clinician is determined to be a QP based on participation in multiple Advanced APMs, but any of the APM Entities in which the eligible clinician participates voluntarily or involuntarily terminates from the Advanced APM before the end of the QP Performance Period, the eligible clinician is not a QP. We proposed to make the same clarification for Partial QP determinations under § 414.1425(d)(4). These clarifying edits specify that this policy applies only within the context of QP and Partial QP determinations based on participation in multiple Advanced APMs, not for all QP determinations. Accordingly, for example, if an eligible clinician is a QP through participation in each of two Advanced APMs under § 414.1425(b)(1), and one APM Entity voluntarily or involuntarily terminates from one of those Advanced APMs, the eligible clinician is still a QP. However, if the eligible clinician is a QP through participation in multiple Advanced APMs under § 414.1425(c)(4), and any APM Entity that eligible clinician participates in that counts towards the QP determination voluntarily or involuntarily terminates from the Advanced APM before the end of the QP Performance Period, the eligible clinician is no longer a QP.
We sought comment on these proposals.
The following is a summary of the public comments received on these proposals and our responses:
In summary, we are finalizing the following policies:
• We are finalizing that we will calculate QP Threshold Scores for participants in Advanced APMs that are actively tested continuously for a minimum of 60 days during the QP Performance Period and start or end during the QP Performance Period based on data only for the dates that APM Entities were able to participate in the Advanced APM per the terms of the Advanced APM, not for the full QP Performance Period. We are codifying this policy at § 414.1425(c)(7)(i).
• We are finalizing that we will make QP determinations under § 414.1425(c)(4) for eligible clinicians participating in multiple Advanced APMs using the full QP Performance Period even if the eligible clinician participates in one or more Advanced APMs that start or end during the QP Performance Period. We are codifying this policy at § 414.1425(c)(7)(ii).
• We are finalizing amendments to §§ 414.1425(c)(6) and (d)(4) to reflect our policy for the situation where an eligible clinician is in multiple APM Entities participating in multiple Advanced APMs, and it would be possible for this eligible clinician to attain QP or Partial QP status based solely on performance in non-terminating APM Entities when one of the APM Entities terminates prior to the end of the QP Performance Period. We will evaluate whether the individual eligible clinician's participation in the remaining Advanced APMs would meet the relevant QP or Partial QP Threshold.
Section 1833(z)(2)(B)(ii) of the Act requires that beginning in payment year 2021, in addition to the Medicare Option, eligible clinicians may become QPs through the Combination All-Payer and Medicare Payment Threshold Option, which we refer to as the All-Payer Combination Option. In the CY 2017 Quality Payment Program final rule, we finalized our overall approach to the All-Payer Combination Option (81 FR 77459). The Medicare Option focuses on participation in Advanced APMs, and we make determinations under this option based on Medicare Part B covered professional services attributable to services furnished through an APM Entity. The All-Payer Combination Option does not replace or supersede the Medicare Option; instead, it will allow eligible clinicians to become QPs by meeting the QP thresholds through a pair of calculations that assess Medicare Part B covered professional services furnished through Advanced APMs, and a combination of both Medicare Part B covered professional services furnished through Advanced APMs and services furnished through Other Payer Advanced APMs. We finalized that beginning in payment year 2021, we will conduct QP determinations sequentially so that the Medicare Option is applied before the All-Payer Combination Option (81 FR 77438). The All-Payer Combination Option encourages eligible clinicians to participate in payment arrangements with payers other than Medicare that have payment designs that satisfy the Other Payer Advanced APM criteria. It also encourages sustained participation in Advanced APMs across multiple payers.
We finalized that the QP determinations under the All-Payer Combination Option are based on payment amounts or patient counts as illustrated in Tables 36 and 37, and Figures 1 and 2 (81 FR 77460-77461). We also finalized that, in making QP determinations, we will use the Threshold Score that is most advantageous to the eligible clinician toward achieving QP status for the year, or if QP status is not achieved, Partial QP status for the year (81 FR 77475).
Unlike the Medicare Option, where we have access to all of the information necessary to determine whether an APM meets the criteria to be an Advanced APM, we cannot determine whether an other payer arrangement meets the criteria to be an Other Payer Advanced APM without receiving the required information from an external source. Similarly, we do not have the necessary payment amount and patient count information to determine under the All-Payer Combination Option whether an eligible clinician meets the payment amount or patient count threshold to be a QP without receiving the required information from an external source.
We finalized the process that eligible clinicians can use to seek a QP determination under the All-Payer Combination Option (81 FR 77478-77480):
• The eligible clinician submits to CMS sufficient information on all relevant payment arrangements with other payers;
• Based upon that information CMS determines that at least one of those payment arrangements is an Other Payer Advanced APM; and
• 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.
In the CY 2018 Quality Payment Program proposed rule, we proposed additional details around our plans for implementing the All Payer Combination Option and we also proposed certain modifications to our previously finalized policies (82 FR 30177 through 30207).
We address the following topics in this section of this final rule with comment period: (1) Other Payer Advanced APM Criteria; (2) Determination of Other Payer Advanced APMs; and (3) Calculation of All-Payer Combination Option Threshold Scores and QP Determinations.
Our goal is to align the Advanced APM criteria under the Medicare Option and the Other Payer Advanced APM criteria under the All-Payer Combination Option as permitted by statute and as feasible and appropriate. We believe this alignment will help simplify the Quality Payment Program and encourage participation in Other Payer Advanced APMs.
In the CY 2017 Quality Payment Program final rule, we finalized that in general, an other payer arrangement with any payer other than traditional Medicare, including Medicare Health Plans, which include Medicare Advantage, Medicaid-Medicaid Plans, 1876 Cost Plans, and Programs of All Inclusive Care for the Elderly (PACE) plans, will be an Other Payer Advanced APM if it meets all three of the following criteria:
• The other payer arrangement requires at least 50 percent of participating eligible clinicians in each participating APM Entity, or each hospital if hospitals are the APM Entities, to use CEHRT to document and communicate clinical care (81 FR 77464-77465);
• The other payer arrangement requires that quality measures comparable to measures under the MIPS quality performance category apply, which means measures that are evidence-based, reliable and valid; and, if available, at least one measure must be an outcome measure (81 FR 77466); and
• The other payer arrangement either: (1) Requires APM Entities to bear more than nominal financial risk if actual aggregate expenditures exceed expected aggregate expenditures (under either the generally applicable or Medicaid Medical Home Model standards for nominal amount of financial risk, as applicable); or (2) is a Medicaid Medical Home Model that meets criteria comparable to Medical Home Models expanded under section 1115A(c) of the Act (81 FR 77466-77467).
In the CY 2018 Quality Payment Program proposed rule, we proposed the following:
• We proposed that an other payer arrangement would be considered to meet the nominal amount standard if, under the terms of the other payer arrangement, the total amount that an APM Entity potentially owes the payer or foregoes is equal to at least: for the 2019 and 2020 QP Performance Periods, 8 percent of the total combined revenues from the payer of providers and suppliers in participating APM Entities.
• We proposed that to be an Other Payer Advanced APM, a Medicaid Medical Home Model must require that the total annual amount that an APM Entity potentially owes or foregoes under the Medicaid Medical Home Model must be at least:
++ For QP Performance Period 2019, 3 percent of the APM Entity's total revenue under the payer.
++ For QP Performance Period 2020, 4 percent of the APM Entity's total revenue under the payer.
++ For QP Performance Period 2021 and later, 5 percent of the APM Entity's total revenue under the payer.
In the CY 2017 Quality Payment Program final rule, we finalized definitions of Medical Home Model and Medicaid Medical Home Model at § 414.1305. The statute 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 Quality Payment Program.
We recognize that there may be medical homes that are operated by other payers that may be appropriately considered medical home models under the All-Payer Combination Option. Examples of these arrangements may include those aligned with the Comprehensive Primary Care Plus (CPC+) Model. Therefore, in the CY 2018 Quality Payment Program proposed rule, we sought comment on whether we should define the term Other Payer Medical Home Model as an other payer arrangement that is determined by us to have the following characteristics:
• The other payer 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 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; and
• At least four of the following:
++ 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, fee-for-service payments (for example, shared savings or population-based payments).
We also explained that similar to Medical Home Models and Medicaid Medical Home Models, we believe that Other Payer Medical Home Models could be considered unique types of other payer arrangements for purposes of the Quality Payment Program. We anticipate that participants in these arrangements may generally be more limited in their ability to bear financial risk than other entities because they may be smaller and predominantly include primary care practitioners, whose revenues are a smaller fraction of the patients' total cost of care than those of other eligible clinicians. Because of these factors, we explained that we believe it may be appropriate to determine whether an Other Payer Medical Home Model satisfies the financial risk criterion by using special Other Payer Medical Home Model financial risk and nominal amount standards, which could be different from the generally applicable Other Payer Advanced APM standards and would be identical to the Medicaid Medical Home Model financial risk and nominal amount standards (82 FR 30180).
We noted a particular interest in, and sought comment on, whether there are payment arrangements that currently exist that would meet this definition. We encouraged commenters to suggest whether such payment arrangements would meet the existing generally applicable Other Payer Advanced APM financial risk and nominal amount standards. We also requested comments on any special considerations that might be relevant when establishing a definition for a medical home model standard for payers with payment arrangements that would not fit under the Medical Home Model or Medicaid Medical Home Model definitions, including how the 50 clinician cap we finalized in the CY 2017 Quality Payment Program final rule (81 FR 77428-77429) Medical Home Model nominal amount standard would apply.
The following is a summary of the public comments received in response
In the CY 2017 Quality Payment Program final rule, we finalized policies to assess whether an other payer arrangement requires participating APM Entities to bear more than nominal financial risk if aggregate expenditures exceed expected aggregated expenditures. This Other Payer Advanced APM criterion has two components: A financial risk standard and a nominal amount standard. The financial risk standard defines what it means for an APM Entity to bear financial risk if actual aggregate expenditures exceed expected aggregate expenditures under an other payer arrangement. We finalized a generally applicable financial risk standard and a Medicaid Medical Home Model financial risk standard for Other Payer Advanced APMs. (81 FR 77466 through 77474).
We finalized that for an other payer arrangement to meet the generally applicable financial risk standard for Other Payer Advanced APMs, if an APM Entity's actual aggregate expenditures exceed expected aggregate expenditures during a specified performance period, the payer must:
• Withhold payment of services to the APM Entity and/or the APM Entity's eligible clinicians;
• Reduce payment rates to APM Entity and/or the APM Entity's eligible clinicians; or
• Require direct payments by the APM Entity to the payer (81 FR 77467).
We also finalized 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 during a specified performance period, the Medicaid Medical Home Model must:
• Withhold payment of services to the APM Entity and/or the APM Entity's eligible clinicians;
• Reduce payment rates to APM Entity and/or the APM Entity's eligible clinicians;
• Require direct payments by the APM Entity to the payer; or
• Require the APM Entity to lose the right to all or part of an otherwise guaranteed payment or payments (81 FR 77468-77469).
The generally applicable nominal amount standard that we finalized in the CY 2017 Quality Payment Program final rule for Other Payer Advanced APMs differs from the generally applicable nominal amount standard for Advanced APMs in two ways (81 FR 77471).
First, the finalized generally applicable nominal amount standard for Advanced APMs only requires an APM to meet one measure of risk—total risk (81 FR 77424). The finalized generally applicable nominal amount standard for Other Payer Advanced APMs involves assessment of the following three measures of risk:
• Marginal risk—the percentage of the amount by which actual expenditures exceed expected expenditures for which an APM Entity would be liable under the payment arrangement.
• Minimum loss rate—a percentage by which actual expenditures may exceed expected expenditures without triggering financial risk.
• Total risk—the maximum potential payment for which an APM Entity could be liable under a payment arrangement.
We reiterate that as we described in the CY 2017 Quality Payment Program final rule, although we did not formally adopt marginal risk or minimum loss rate criteria for Advanced APMs, we pointed out that all current Advanced APMs would meet these standards, and that we intend that all future Advanced APMs would meet the three measures of risk as well (81 FR 77426). Therefore, we do not expect the application of the different criteria between Advanced APMs and Other Payer Advanced APMs to produce meaningfully different results in terms of actual risk faced by participants.
Second, the finalized generally applicable Advanced APM nominal amount standard allows for total risk to be defined in one of two ways, based on expected expenditures (the benchmark-based standard) or based on revenue (the revenue-based standard) (81 FR 77427). In contrast, the finalized Other Payer Advanced APM generally applicable nominal amount standard is only based on expected expenditures (81 FR 77471).
In the CY 2017 Quality Payment program final rule, we sought comments on using the expected expenditures approach for the generally applicable Other Payer Advanced APM nominal amount standard.
In the CY 2018 Quality Payment Program proposed rule, we did not propose to modify the marginal risk and minimum loss rates as finalized in the 2017 Quality Payment Program final rule as part of the generally applicable nominal amount standard for Other Payer Advanced APMs. We noted that we continue to believe that using these measures of risk will ensure that payment arrangements involving other payers and APM Entities or eligible clinicians cannot be engineered in such a way as to provide eligible clinicians
The following is a summary of the public comments received in response to this request for comment and our responses:
In the CY 2018 Quality Payment Program proposed rule, we proposed to add a revenue-based nominal amount standard to the generally applicable nominal amount standard for Other Payer Advanced APMs that is parallel to the generally applicable revenue-based nominal amount standard for Advanced APMs. Specifically, we proposed that an other payer arrangement would meet the total risk component of the proposed nominal risk standard if, under the terms of the other payer arrangement, the total amount that an APM Entity potentially owes the payer or foregoes is equal to at least: For the 2019 and 2020 QP Performance Periods, 8 percent of the total combined revenues from the payer of providers and suppliers in participating APM Entities. This standard would be in addition to the previously finalized expenditure-based standard. We explained that a payment arrangement would only need to meet one of the two standards. We would use this standard only for other payer arrangements where financial risk is expressly defined in terms of revenue in the payment arrangement. We sought comment on this proposal.
The following is a summary of the public comments received on this proposal and our responses:
For Advanced APMs, we may determine that an APM still meets the generally applicable revenue-based nominal amount standard, even if risk is not explicitly defined in terms of revenue, by comparing model downside risk to the estimated average Medicare revenue of model participants. Because we have direct access to Medicare claims data, we can estimate such an average. For other payers, we do not have similar direct access to claims data. As such, there are significant operational challenges to identifying whether an other payer arrangement would satisfy the revenue-based nominal amount standard when the other payer arrangement does not define risk explicitly in terms of revenue.
We sought comment on this proposal. We did not receive any comments in response to this proposal.
In the CY 2018 Quality Payment Program proposed rule, we proposed that under the generally applicable nominal amount standard for Other Payer Advanced APMs, an other payer arrangement would need to meet either the benchmark-based nominal amount standard or the revenue-based nominal amount standard and need not meet both. We noted that we believe the proposed approach to the nominal amount standard would expand the opportunities for other payer arrangements to meet the generally applicable nominal amount standard, and would allow closer alignment between Medicare and other payers as new payment arrangements are introduced and evolve.
We sought comment on this proposal. We received no comments in response to this proposal.
We also sought comment on whether we should consider a different, potentially lower, revenue-based nominal amount standard only for small practices and those in rural areas that are not participating in a Medicaid Medical Home Model for the 2019 and 2020 QP Performance Periods (82 FR 30182). We noted we would use the definition of small practices and rural areas that is in § 414.1305. We noted that we believe that a different, potentially lower, revenue-based nominal amount standard for the 2019 and 2020 QP Performance Periods specifically for small and rural organizations may allow for increased participation in Other Payer Advanced APMs, which may help increase the quality and coordination of care beneficiaries receive as a result. Specifically, we sought comment on whether such a standard should apply only to small and, or, rural practices that are participants in an Other Payer Advanced APM, or also to small and/or rural practices that join larger APM Entities to participate in APMs. We also sought comment on how we should decide where a practice is located to determine whether it is operating in a rural area is defined in § 414.1305.
The following is a summary of the public comments received in response to this request for comments and our responses:
In the CY 2017 Quality Payment Program final rule, in addition to the financial risk standard for Medicaid Medical Home Models, we finalized that to be an Other Payer Advanced APM, a Medicaid Medical Home Model must require that the total annual amount that an APM Entity potentially owes or foregoes be at least the following amounts in a given performance year:
• In 2019, 4 percent of the APM Entity's total revenues under the payer.
• In 2020 and later, 5 percent of the APM Entity's total revenues under the payer (81 FR 77472).
In the CY 2018 Quality Payment Program proposed rule, we reconsidered the incremental annual increases we had established for the Medicaid Medical Home Model nominal amount standard to take effect over several years. Our policy finalized in the CY 2017 Quality Payment Program final rule set forth what we envisioned was a gradually increasing but achievable amount of risk that would apply over time. In general, we still believe this to be true, but recognize that establishing an even more gradual increase in risk for Medicaid Medical Home Models may better suit many APM Entities in Medicaid Medical Home Models that have little experience with risk. To that end, we explained that we believe a small reduction of risk in the Medicaid Medical Home Model nominal amount standard beginning in the 2019 QP Performance Period may allow for greater flexibility in setting financial risk thresholds that would encourage more participation in Medicaid Medical Home Models and be more sustainable for the type of APM Entities that would potentially participate in Medicaid Medical Home Models.
Therefore, in the CY 2018 Quality Payment Program proposed rule, we proposed that to be an Other Payer Advanced APM, a Medicaid Medical Home Model must require that the total annual amount that an APM Entity potentially owes or foregoes under the Medicaid Medical Home Model must be at least:
• For QP Performance Period 2019, 3 percent of the APM Entity's total revenue under the payer.
• For QP Performance Period 2020, 4 percent of the APM Entity's total revenue under the payer.
• For QP Performance Period 2021 and later, 5 percent of the APM Entity's total revenue under the payer (82 FR 30182 through 30183).
We sought comment on this proposal.
The following is a summary of the public comments received on this proposal and our responses:
Therefore, we are amending § 414.1420(d)(4)(i) and (iii) to state that meet the Medicaid Medical Home Model nominal amount standard, a Medicaid Medical Home Model must require that the total annual amount that an APM Entity potentially owes a payer or foregoes under the Medicaid Medical Home Model must be at least:
• For QP Performance Period 2019, 3 percent of the average estimated total revenue of the participating providers or other entities under the payer.
• For QP Performance Period 2020, 4 percent of the average estimated total revenue of the participating providers or other entities under the payer.
• For QP Performance Period 2021 and later, 5 percent of the average estimated total revenue of the participating providers or other entities under the payer.
In summary, we are finalizing the following policies:
• We are finalizing that an other payer arrangement would meet the generally applicable revenue-based nominal amount standard we are finalizing if, under the terms of the other payer arrangement, the total amount that an APM Entity potentially owes the payer or foregoes is equal to at least: For the 2019 and 2020 QP Performance Periods, 8 percent of the total combined revenues from the payer to providers and other entities in the payment arrangement only for arrangements that are expressly defined in terms of revenue. We are codifying this policy by revising § 414.1420(d)(3)(i).
• We are finalizing at § 414.1420(d)(4)(i) and (iii) that a Medicaid Medical Home Model would meet the benchmark-based Medicaid Home Model nominal amount standard if, under the terms of the other payer arrangement, the total annual amount that an APM Entity potentially owes or foregoes under the Medicaid Medical Home Model must be at least:
++ For QP Performance Period 2019, 3 percent of the average estimated total revenue of the participating providers or other entities under the payer.
++ For QP Performance Period 2020, 4 percent of the average estimated total revenue of the participating providers or other entities under the payer.
++ For QP Performance Period 2021 and later, 5 percent of the average estimated total revenue of the participating providers or other entities under the payer.
For other payer arrangements, in the CY 2017 Quality Payment Program final rule, we specified that an APM Entity or eligible clinician must submit, by a date and in a manner determined by us, information necessary to identify whether a given payment arrangement satisfies the Other Payer Advanced APM criteria (81 FR 77480). We finalized that we will identify Medicaid APMs and Medicaid Medical Home Models that meet the Other Payer Advanced APM criteria before the beginning of the QP Performance Period (81 FR 77478-77480). We also sought comment on the overall process for reviewing payment arrangements to determine whether they are Other Payer Advanced APMs, and we also sought comment on whether we should create a separate pathway to identify whether other payer arrangements with Medicaid as a payer meet the Other Payer Advanced APM criteria (81 FR 77463).
We note that in the CY 2017 Quality Payment Program final rule, we codified some of our final policies pertaining to the Determination of Other Payer Advanced APMs at § 414.1410(b)(2). In this CY 2018 Quality Payment Program final rule with comment period, we are removing § 414.1410(b)(2) and are codifying policies pertaining to Other Payer Advanced APM determinations at § 414.144.
In the CY 2018 Quality Payment Program proposed rule, we proposed the following:
• We proposed to allow certain other payers, including payers with payment arrangements authorized under Title XIX, Medicare Health Plan payment arrangements, and payers with payment arrangements aligned with a CMS Multi-Payer Model to request that we determine whether their other payer arrangements are Other Payer Advanced APMs starting prior to the 2019 QP Performance Period and each year thereafter. We proposed to allow remaining other payers, including commercial and other private payers, to request that we determine whether other payer arrangements are Other Payer Advanced APMs starting in 2019 prior to the 2020 QP Performance Period, and annually each year thereafter. We proposed to generally refer to this process as the Payer Initiated Other Payer Advanced APM Determination Process (Payer Initiated Process), and we proposed that the Payer Initiated Process would generally involve the same steps for each payer type for each QP Performance Period. We proposed that these Other Payer Advanced APM determinations would be in effect for only one year at a time. We proposed
• We proposed that payers would be required to use the Payer Initiated Submission Form to request that we make an Other Payer Advanced APM determination. We proposed that the Submission Period opening date and Submission Deadline would vary by payer type to align with existing CMS processes for payment arrangements authorized under Title XIX, Medicare Health Plan payment arrangements, and payers with payment arrangements aligned with a CMS Multi-Payer Model to the extent possible and appropriate.
• We proposed that if we determine that the payer has submitted incomplete or inadequate information, we would inform the payer and allow the payer to submit additional information no later than 10 business days from the date we inform the payer. For each other payer arrangement for which the payer does not submit sufficient information, we would not make a determination in response to that request submitted via the Payer Initiated Submission Form.
• We proposed that if a payer uses the same other payer arrangement in other commercial lines of business that the payer has submitted for determination as a Title XIX, Medicare Health Plan, or CMS Multi-Payer Model payment arrangement, we will allow the payer to concurrently request that we determine whether those other payer arrangements are Other Payer Advanced APMs as well.
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• We proposed that, for each other payer arrangement for which a payer requests us to determine whether it is an Other Payer Advanced APM, the payer must complete and submit the Payer Initiated Submission Form by the relevant Submission Deadline.
• We proposed that through the Eligible Clinician Initiated Process, APM Entities and eligible clinicians participating in other payer arrangements would have an opportunity to request that we determine for the relevant QP Performance Period whether those other payer arrangements are Other Payer Advanced APMs. The Eligible Clinician Initiated Process could also be used to request determinations before the beginning of a QP Performance Period for other payer arrangements authorized under Title XIX.
• We proposed that APM Entities or eligible clinicians would be required to use the Eligible Clinician Initiated Submission Form to request that we make an Other Payer Advanced APM determination.
• We proposed that if we determine that an APM Entity or eligible clinician has submitted incomplete or inadequate information, we would inform the payer and allow the payer to submit additional information no later than 10 business days from the date we inform the APM Entity or eligible clinician. For each other payer arrangement for which the APM Entity or eligible clinician does not submit sufficient information, we would not make a determination in response to that request submitted via the Eligible Clinician Initiated Submission Form.
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• We proposed that, for each other payer arrangement for which a payer requests us to determine whether it is an Other Payer Advanced APM, all payers must complete and submit the Payer Initiated Submission Form by the relevant Submission Deadline. We proposed that the Payer Initiated Submission Form would allow payers to include descriptive language for each of the required information elements. We proposed to require the name and description of the arrangement, nature of the arrangement, QP Performance Period for which the arrangement is available, participant eligibility criteria, and location(s) where the arrangement will be available so that we can verify whether eligible clinicians who may tell us that they participate in such arrangements are eligible to do so. We proposed to require that payers submit documentation that supports the information they provided in the Payer Initiated Submission Form and that is sufficient to enable us to determine whether the other payer arrangement is an Other Payer Advanced APM.
• We proposed that, for each other payer arrangement for which an APM Entity or eligible clinician requests us to determine whether it is an Other Payer Advanced APM, all eligible clinicians must complete and submit the Eligible Clinician Initiated Submission Form by the relevant Submission Deadline. We proposed that the Eligible Clinician Initiated Submission Form would allow APM Entities or eligible clinicians to include descriptive language for each of the required information elements. We proposed to require the name and description of the arrangement, nature of the arrangement, QP Performance Period for which the arrangement is available, participant eligibility criteria, and location(s) where the arrangement will be available so that we can verify whether eligible clinicians who may tell us that they participate in such arrangements are eligible to do so. We proposed to require that APM Entities or eligible clinicians submit documentation that supports the information they provided in the Eligible Clinician Initiated Submission Form and that is sufficient to enable us to determine whether the other payer arrangement is an Other Payer Advanced APM.
• We proposed that, for each other payer arrangement for which an APM Entity or eligible clinician requests us to determine whether it is an Other Payer Advanced APM, the APM Entity or eligible clinician must complete and submit the Eligible Clinician Initiated Submission Form by the relevant Submission Deadline.
• We proposed to add a new requirement at § 414.1445(d) stating that a payer that submits information pursuant to § 414.1445(c) must certify to the best of its knowledge that the information submitted to us through the Payer Initiated Process is true, accurate, and complete. Additionally, we proposed that this certification must accompany the Payer Initiated Submission Form and any supporting documentation that payers submit to us through the Payer Initiated Process.
• We also proposed to revise the monitoring and program integrity provisions at § 414.1460 to ensure the integrity of the Payer Initiated Process. Specifically, we proposed to require payers that choose to submit information through the Payer Initiated Process to maintain such books, contracts, records, documents, and other evidence as necessary to audit an Other Payer Advanced APM determination, and that such information and supporting documentation must be maintained for 10 years after submission and must be provided to CMS upon request. We also proposed to specify that information submitted by payers for purposes of the All-Payer Combination Option may be subject to audit by CMS.
• We proposed to remove the requirement at § 414.1445(b)(3) that payers must attest to the accuracy of information submitted by eligible clinicians. We also proposed to remove the attestation requirement at § 414.1460(c) and add a requirement at § 414.1445(d) that an APM Entity or eligible clinician that submits information pursuant to § 414.1445(c) must certify to the best of its knowledge that the information it submitted to us is true, accurate, and complete. We also proposed that this certification must accompany the submission.
• We proposed to remove the record retention requirement at § 414.1445(c) and only address the record retention issue at § 414.1460(e) stating that APM Entities and eligible clinicians must maintain such books, contracts, records, documents, and other evidence as necessary to enable the audit of an Other Payer Advanced APM determination, QP determination, and the accuracy of an APM Incentive Payment.
• We proposed that, with the exception of the specific information we proposed to make publicly available as stated above, the information a payer submits to us through the Payer Initiated Process and the information an APM Entity or eligible clinician submits
• We proposed that we would presume that an other payer arrangement would satisfy the 50 percent CEHRT use criterion if we receive information and documentation from the APM Entity or eligible clinician through the Eligible Clinician Initiated Process showing that the other payer arrangement requires the requesting eligible clinician(s) to use CEHRT to document and communicate clinical information.
In the CY 2018 Quality Payment Program proposed rule, we proposed to allow certain other payers, including payers with payment arrangements authorized under Title XIX, Medicare Health Plan payment arrangements, and payers with payment arrangements aligned with a CMS Multi-Payer Model to request that we determine whether their other payer arrangements are Other Payer Advanced APMs starting prior to the 2019 QP Performance Period and each year thereafter. We proposed to generally refer to this process as the Payer Initiated Other Payer Advanced APM Determination Process (Payer Initiated Process) (82 FR 30183).
The following is a summary of the public comments received on these proposals and our responses:
In the CY 2018 Quality Payment Program proposed rule, if a payer requests that we determine whether a payment arrangement authorized under Title XIX, a Medicare Health Plan payment arrangement, or a payment arrangement in a CMS Multi-Payer Model is an Other Payer Advanced APM, and the payer uses the same other payer arrangement in other commercial lines of business, we proposed to allow the payer to concurrently request that we determine whether those other payer arrangements are Other Payer Advanced APMs as well. We proposed to make Other Payer Advanced APM determinations for each individual payment arrangement (82 FR 30183). We sought comment on this proposal. The following is a summary of the public comments received on this proposal and our responses:
In the CY 2018 Quality Payment Program proposed rule, we proposed that these Other Payer Advanced APM determinations would be in effect for only one year at a time (82 FR 30183).
We sought comment on this proposal. The following is a summary of the public comments received on this proposal and our responses:
We also proposed to allow remaining other payers, including commercial and other private payers, to request that we determine whether other payer arrangements are Other Payer Advanced APMs starting in 2019 prior to the 2020 QP Performance Period and annually each year thereafter. In the CY 2018 Quality Payment Program proposed rule, we stated that we believe that phasing in the Payer Initiated Process would allow us to gain experience with the determination process on a limited basis with payers where we have the strongest relationships and existing processes that we believe can help facilitate submitting this information, and that we anticipated making improvements and refinements to this process, which we believe will help us facilitate receiving this information from the remaining other payers (82 FR 30183). We refer readers to section II.D.6.c.(5)(a) of this final rule with comment period for a discussion of these policies.
We proposed that the Payer Initiated Process would be voluntary for all payers.
We sought comment on this proposal. We did not receive any comments in response to this proposal.
In the CY 2018 Quality Payment Program proposed rule, we proposed that the Payer Initiated Process would generally involve the same steps for each payer type as listed below for each QP Performance Period, and we elaborated on details within this framework that are specific to payer type (82 FR 30183 through 30184). We discuss our final policies below.
The following is a summary of the public comments received on these proposals and our responses:
We sought comment on this proposal. The following is a summary of the comments received on this proposal and our responses:
We sought comment on this proposal. The following is a summary of the public comments received on this proposal and our responses:
The following is a summary of the public comments received on this topic and our responses:
We still intend to post this list prior to the start of the relevant QP Performance Period and then update it to include Other Payer Advanced APMs that we determine based on requests received through the Eligible Clinician Initiated Process.
In the CY 2018 Quality Payment Program proposed rule, we proposed that through the Eligible Clinician Initiated Process, APM Entities and eligible clinicians participating in other payer arrangements would have an opportunity to request that we determine for the year whether those other payer arrangements are Other Payer Advanced APMs. The Eligible Clinician Initiated Process could also be used to request determinations before the beginning of a QP Performance Period for other payer arrangements authorized under Title XIX. The Eligible Clinician Initiated Process would not be necessary for, or applicable to, other payer arrangements that are already determined to be Other Payer Advanced APMs through the Payer Initiated Process (82 FR 30184).
The following is a summary of the public comments received on this proposal and our responses:
The following is a summary of the public comments received on these proposals and our responses:
The following is a summary of the public comments received on these proposals and our responses:
The following is a summary of the public comments received on these proposals and our responses:
In the CY 2018 Quality Payment Program proposed rule, we noted that APM Entities and eligible clinicians who submit complete Eligible Clinician Initiated Submission Forms by September 1 of the same calendar year as the relevant QP Performance Period may allow for us to make Other Payer Advanced APM determinations and inform APM Entities or eligible clinicians of those determinations prior to the December 1 QP Determination Submission Deadline. If we determine that an other payer arrangement is not an Other Payer Advanced APM, notifying APM Entities or eligible clinicians of such a determination may help them avoid the burden of submitting payment amount and patient count information for that payment arrangement. We intend to make these early notifications to the extent possible. We proposed that APM Entities or eligible clinicians may submit information regarding an other payer arrangement for a subsequent QP Performance Period even if we have determined that the other payer arrangement is not an Other Payer Advanced APM for a prior year (82 FR 30185).
The following is a summary of the public comments received on these proposals and our responses:
We still intend to post this list prior to the start of the relevant QP Performance Period and update it to include Other Payer Advanced APMs that we determine based on requests received through the Eligible Clinician Initiated Process.
In the CY 2018 Quality Payment Program proposed rule, we noted that payers, APM Entities, and eligible clinicians may request that we determine whether payment arrangements authorized under Title XIX of the Act are Medicaid APMs or Medicaid Medical Home Models that meet the Other Payer Advanced APM criteria. We explained that there are some differences between the determination process for other payer arrangements where Medicaid is the payer and the process for other payer arrangements with other types of payers. These differences stem in part from the requirements specified in sections 1833(z)(2)(B)(ii)(bb) and 1833(z)(2)(C)(ii)(bb) of the Act for QP determinations under the All-Payer Combination Option. We noted that we interpret those statutory provisions to direct us, when making QP determinations under the All-Payer Combination Option, to exclude from the calculation of “all other payments” any payments made (or patients under the patient count method) under Title XIX in a state in which there is no available Medicaid APM (which by definition at § 414.1305 meets the Other Payer Advanced APM criteria) or Medicaid Medical Home Model that meets the Other Payer Advanced APM criteria (82 FR 30185).
To implement this requirement, we explained in the CY 2018 Quality Payment Program proposed rule that we need to determine which states have no available Medicaid APMs or Medicaid Medical Home Models that meet the Other Payer Advanced APM criteria during a given QP Performance Period. We noted that we believe that it is important for us to make this determination prior to the QP Performance Period, and to announce the Medicaid APMs and Medicaid Medical Home Models that meet the Other Payer Advanced APM criteria and the locations where they are available, so that eligible clinicians can assess whether their Title XIX payments and patients would be excluded under the All-Payer Combination Option for that particular performance year. If, for a given state, we receive no requests to make determinations for other payer arrangements that could be Medicaid APMs or Medicaid Medical Home Models that are Other Payer Advanced APMs for the year through either the Payer Initiated Process or the Eligible Clinician Initiated Process, we would assume that there are no Medicaid APMs or Medicaid Medical Home Models that meet the Other Payer Advanced APM criteria in that state for the relevant QP Performance Period. Accordingly, we would exclude Title XIX payments and patients from the All-Payer Combination Option calculations for eligible clinicians in that state (82 FR 30185).
In the CY 2018 Quality Payment Program proposed rule, we proposed that any states and territories (which we refer to as states) that have in place a state plan under Title XIX may request that we determine prior to the QP Performance Period whether other payer arrangements authorized under Title XIX are Medicaid APMs or Medicaid Medical Home Models that meet the Other Payer Advanced APM criteria, in other words, are Other Payer Advanced APMs, under the Payer Initiated Process. States include the 50 states, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands.
We proposed to allow states to request determinations for both Medicaid fee-for-service and Medicaid managed care plan payment arrangements. We explained that states often use managed care plan contracts to implement payment arrangements, and a substantial portion of the Medicaid beneficiary population receives their health care services through Medicaid managed care plans. We noted that we expect that states would work closely with their managed care plans to identify and collect relevant information. However, we proposed to accept requests regarding payment arrangements authorized under Title XIX under the Payer Initiated Process only from the state, not from a Medicaid managed care plan, as states are responsible ultimately for the administration of their Medicaid programs (82 FR 30186).
The following is a summary of the public comments received on these proposals and our responses:
Below we discuss our final policies for the Payer Initiated Process for payment arrangements authorized under Title XIX.
We intend to work with states as they prepare and submit Payer Initiated Submission Forms for our review. In completing the Payer Initiated Submission Form, states could refer to information they have already submitted to us regarding their payment arrangements to support their request for a determination. This information could include, for example, submissions that states typically make to us to obtain authorization to modify their Medicaid payment arrangements, such as a State Plan Amendment or an 1115 demonstration's waiver application, Special Terms and Conditions document, implementation protocol document, or other document describing the 1115 demonstration arrangements approved by CMS.
The following is a summary of the public comments received on these proposals and our responses:
The following is a summary of the public comments received on this proposal and our responses:
The following is a summary of the public comments received on these proposals and our responses:
We intend to provide ongoing assistance through existing conversations or negotiations as states design and develop new payment arrangements that may be identified as Other Payer Advanced APMs. As states begin discussions with us regarding the development of other payer arrangements through the different legal authorities available under Title XIX or Title XI of the Act, we would help states consider and address the Other Payer Advanced APM criteria.
In the CY 2018 Quality Payment Program proposed rule, we proposed that APM Entities and eligible clinicians may request determinations for any Medicaid payment arrangements in which they are participating at an earlier point, prior to the QP Performance Period. This would allow all clinicians in a given state or county to know before the beginning of the QP Performance Period whether their Title XIX payments and patients would be excluded from the all-payer calculations that are used for QP determinations for the year under the All-Payer Combination Option.
We sought comment on this proposal. The following is a summary of the public comments received on this proposal and our responses:
Below we discuss our policies for the Eligible Clinician Initiated Process for payment arrangements authorized under Title XIX.
We sought comment on this proposal. We received no comments in response to this proposal.
The final timelines for both the Payer Initiated and Eligible Clinician Initiated Other Payer Advanced APM Determination Processes for payment arrangements authorized under Title XIX are summarized in Table 38.
For purposes of carrying out the Quality Payment Program, we proposed to define the term CMS Multi-Payer Model at § 414.1305 as an Advanced APM that CMS determines, per the terms of the Advanced APM, has at least one other payer arrangement that is designed to align with the terms of that Advanced APM. Examples of CMS Multi-Payer Models include the Comprehensive Primary Care Plus
We sought comment on this proposal. We received no comments in response to this proposal.
Other payer arrangements that are aligned with a CMS Multi-Payer Model, by definition, are not APMs, and thus, cannot be Advanced APMs under the Medicare Option. We recognize, though, that these other payer arrangements could be Other Payer Advanced APMs. We therefore proposed that beginning in the first QP Performance Period under the All-Payer Combination Option, payers with other payer arrangements aligned with a CMS Multi-Payer Model may request that we determine whether those aligned other payer arrangements are Other Payer Advanced APMs. Because there may be differences between the other payer arrangements that are aligned with an Advanced APM in a CMS Multi-Payer Model, we proposed to make separate determinations about each of those other payer arrangements on an individual basis. In other words, an other payer arrangement aligned with an Advanced APM in a CMS Multi-Payer Model is not automatically an Other Payer Advanced APM by virtue of its alignment.
The following is a summary of the public comments received on these proposals and our responses:
In the CY 2018 Quality Payment Program proposed rule, we stated that because there can be payment arrangements authorized under Title XIX or Medicare Health Plan payment arrangements that are aligned with a CMS Multi-Payer Model, we proposed that payers, APM Entities, or eligible clinicians who want to request that we determine whether those arrangements are Other Payer Advanced APMs would use the processes specified for payment arrangements authorized under Title XIX and Medicare Health Plan payment arrangements (82 FR 30188).
We sought comment on this proposal. We received no comments in response to this proposal.
Below we discuss our policies for the Payer Initiated Process for payment arrangements aligned with a CMS Multi-Payer Model.
We sought comment on this proposal. We received no comments in response to this proposal.
Below we discuss our policies for the Eligible Clinician Initiated Process for payment arrangements aligned with a CMS Multi-Payer Model.
We sought comment on this proposal. We received no comments in response to this proposal.
Some CMS Multi-Payer Models involve an agreement with a state to test an APM and one or more associated other payer arrangements in that state where the state prescribes uniform payment arrangements across state-based payers. As such, we believe it may be appropriate and efficient for states, rather than any other payer, to submit information to us on these payment arrangements for purposes of requesting an Other Payer Advanced APM determination.
We proposed that, in CMS Multi-Payer Models where a state prescribes uniform payment arrangements across all payers statewide, the state would submit on behalf of payers in the Payer Initiated Process for Other Payer Advanced APMs; we would seek information for the determination from the state, rather than individual payers. The same Payer Initiated Process and timeline described above for CMS Multi-Payer Models would apply. We sought comment on this proposal. Additionally, we sought comment regarding the effectiveness of taking a similar approach in cases where the state does not require uniform payment arrangements across payers.
We sought comment on this proposal. We received no comments in response to our proposal.
The final timelines for both the Payer Initiated and Eligible Clinician Initiated Other Payer Advanced APM Determination Processes for payment arrangements aligned with a CMS Multi-Payer Model are summarized in Table 39.
In the CY 2018 Quality Payment Program proposed rule, we noted that the Medicare Option for QP determinations under sections 1833(z)(2)(A), (2)(B)(i), and (2)(C)(i) of the Act, is based only on the percentage of Part B payments for covered professional services, or patients, that is attributable to payments through an Advanced APM. As such, payment amounts or patient counts under Medicare Health Plans, including Medicare Advantage, Medicare-Medicaid Plans, 1876 Cost Plans, and Programs of All Inclusive Care for the Elderly (PACE) plans, cannot be included in the QP determination calculations under the Medicare Option (81 FR 77473-77474). Instead, eligible clinicians who participate in Other Payer Advanced APMs, including those with Medicare Advantage as a payer, could become QPs based on that participation during the 2019 QP Performance Period in payment year 2021 (82 FR 30190). However, eligible clinicians who participate in Other Payer Advanced APMs with Medicare Advantage as the payer can only achieve QP status if they also participate in an Advanced APM with Medicare fee-for-service.
In light of these statutory limitations, as noted in the CY 2018 Quality Payment Program proposed rule, we received feedback in support of the idea of also incentivizing eligible clinician participation in alternative payment arrangements under Medicare Advantage by providing credit for that participation in QP determinations under the Medicare Option. We noted in the CY 2018 Quality Payment Program proposed rule that we were considering opportunities to address this issue, and we sought comment on such opportunities, including potential models and uses of our waiver and demonstration authorities. Under the
The following is a summary of the public comments received in response to our request for comment and our responses:
In the CY 2018 Quality Payment Program proposed rule, we proposed that Medicare Health Plans may request that we determine whether their payment arrangements are Other Payer Advanced APMs prior to the QP Performance Period by submitting information contemporaneously with the annual bidding process for Medicare Advantage contracts (that is, submitted by the first Monday in June of the year prior to the payment and coverage year) (82 FR 30190).
The following is a summary of the public comments received on this proposal and our responses:
Below we discuss our policies for the Payer Initiated Process for Medicare Health Plan payment arrangements.
We sought comment on this proposal. We received no comments in response to this proposal.
We discuss policies for the Eligible Clinician Initiated Process for Medicare Health Plan payment arrangements below.
We sought comment on this proposal. We received no comments in response to this proposal.
The final timelines for both the Payer Initiated and Eligible Clinician Initiated Other Payer Advanced APM Determination Processes for Medicare Health Plan payment arrangements are summarized in Table 40.
In the CY 2018 Quality Payment Program proposed rule, we proposed to allow the remaining other payers not specifically addressed in proposals, including commercial and other private payers that are not states, Medicare Health Plans or payers with arrangements that are aligned with a CMS Multi-Payer Model, to request that we determine whether other payer arrangements are Other Payer Advanced APMs starting prior to the 2020 QP Performance Period and each year thereafter. We sought comment on this proposal, and we also sought comment on potential challenges to these other payers submitting information to us for Other Payer Advanced APM determinations. We noted that we intend to discuss the Payer Initiated Process for remaining other payers in more detail in future rulemaking (82 FR 30192).
The following is a summary of the public comments received on this proposal and our responses:
We also note that APM Entities and eligible clinicians will be able to submit information about payment arrangements with remaining other payers through the Eligible Clinician Initiated Process for the 2019 QP Performance Period. Therefore, our proposal does not in any way prevent eligible clinicians from receiving credit for participation in such payment arrangements and thereby becoming QPs for the 2019 QP Performance Period.
In the CY 2018 Quality Payment Program proposed rule, we proposed that APM Entities and eligible clinicians may request that we determine whether an other payer arrangement with one of these other payers is an Other Payer Advanced APM beginning in the 2019 QP Performance Period (82 FR 30192).
We sought comment on this proposal. We received no comments in response to this proposal.
Below we discuss our final policies for the Eligible Clinician Initiated Process.
We sought comment on this proposal. We received no comments in response to this proposal.
The final timelines for both the Payer Initiated and Eligible Clinician Initiated Other Payer Advanced APM Determination Processes for payment arrangements for remaining other payers are summarized in Table 41.
The final timeline for both the Payer Initiated and Eligible Clinician Initiated Other Payer Advanced APM Determination Processes for all payer types is presented in Table 42.
The timeline for Other Payer Advanced APM Determination Process for the 2019 QP Performance Period by Payer Type table included in the CY 2018 Quality Payment Program proposed rule had one typographical error (82 FR 30193). We correct and clarify in Table 42 in this final rule with comment period that guidance will be made to eligible clinicians, and submission will open, for payments authorized under Title XIX in September 2018, not June 2018.
The following is a summary of the public comments received on the overall timeline and our responses:
In the CY 2017 Quality Payment Program final rule, we finalized that to be assessed under the All-Payer Combination Option, APM Entities or eligible clinicians must submit, in a manner and by a date that we specify, payment arrangement information necessary to assess whether the other payer arrangement meets the Other Payer Advanced APM criteria (81 FR 77480). We are codifying the final policies pertaining to submission of information for Other Payer Advanced APM determinations in this section at § 414.1445(c).
In the CY 2018 Quality Payment Program proposed rule, we noted that we intend to create a Payer Initiated Submission Form that would allow payers to submit the information necessary for us to determine whether a payment arrangement is an Other Payer Advanced APM. We proposed that, for each other payer arrangement for which a payer requests that we determine whether it is an Other Payer Advanced APM, the payer must complete and submit the Payer Initiated Submission Form by the relevant Submission Deadline (82 FR 30194). We finalized these proposals in section II.D.6.c.(1)(b) of this final rule with comment period.
For us to make these determinations, in the CY 2018 Quality Payment Program proposed rule, we proposed to require that payers submit the following information for each other payer arrangement on the Payer Initiated Submission Form:
• Arrangement name;
• Brief description of the nature of the arrangement;
• QP Performance Period for which the arrangement is available;
• Participant eligibility criteria;
• Locations (nationwide, state, or county) where this other payer arrangement will be available;
• Evidence that the CEHRT criterion set forth in § 414.1420(b) is satisfied;
• Evidence that the quality measure criterion set forth in § 414.1420(c) is satisfied, including an outcome measure;
• Evidence that the financial risk criterion set forth in § 414.1420(d) is satisfied; and
• Other documentation as may be necessary for us to determine that the other payer arrangement is an Other Payer Advanced APM (82 FR 30194).
We proposed that the Payer Initiated Submission Form would allow payers to include descriptive language for each of the required information elements. We proposed to require the name and description of the arrangement, nature of the arrangement, QP Performance Period for which the arrangement is available, participant eligibility criteria, and location(s) where the arrangement will be available so that we can verify whether eligible clinicians who may tell us that they participate in such arrangements are eligible to do so. We proposed that a submission for an Other Payer Advanced APM determination submitted by the payer is complete only if all of these information elements are submitted to us.
We proposed to require that payers submit documentation that supports the information they provided in the Payer Initiated Submission Form and that is sufficient to enable us to determine whether the other payer arrangement is an Other Payer Advanced APM. Examples of such documentation would include contracts and other relevant documents that govern the other payer arrangement that verify each required information element, copies of their full contracts governing the arrangement, or some other documents that detail and govern the payment arrangement.
The following is a summary of the public comments received on these proposals and our responses:
In the CY 2018 Quality Payment Program proposed rule, we explained that we intend to create an Eligible Clinician Initiated Submission Form that would allow for APM Entities or eligible clinicians to submit the information necessary for us to determine whether a payment arrangement is an Other Payer Advanced APM. We proposed that, for each other payer arrangement an APM Entity or eligible clinician requests us to determine whether it is an Other Payer Advanced APM, the APM Entity or eligible clinician must complete and submit the Eligible Clinician Initiated Submission Form by the relevant Submission Deadline (82 FR 30194 through 30195). We are finalizing these policies in section II.D. 6.c.(1)(c) of this final rule with comment period.
For us to make these determinations, we proposed to require that the APM Entity or eligible clinician submit the following information for each other payer arrangement:
• Arrangement name;
• Brief description of the nature of the arrangement;
• QP Performance Period for which the arrangement is available;
• Locations (nationwide, state, or county) where this other payer arrangement will be available;
• Evidence that the CEHRT criterion set forth in § 414.1420(b) is satisfied;
• Evidence that the quality measure criterion set forth in § 414.1420(c) is satisfied, including an outcome measure;
• Evidence that the financial risk criterion set forth in § 414.1420(d) is satisfied; and
• Other documentation as may be necessary for us to determine whether the other payer arrangement is an Other Payer Advanced APM.
We proposed that the Eligible Clinician Initiated Submission Form would allow APM Entities and eligible clinicians to include descriptive language for each of the required information elements. We proposed to require the name and description of the arrangement, nature of the arrangement, QP Performance Period for which the arrangement is available, participant eligibility criteria, and, in the case of Title XIX arrangements only, location(s) where the arrangement will be available. We proposed to require evidence that all of the Other Payer Advanced APM criteria are met in order for us to determine that the arrangement is an Other Payer Advanced APM. We proposed that a submission for an Other Payer Advanced APM determination submitted by the APM Entity or eligible clinician is complete only if all of these information elements are submitted to us.
We proposed to require that APM Entities or eligible clinicians submit documentation that supports the information they provided in the Eligible Clinician Initiated Submission Form and that is sufficient to enable us to determine whether the other payer arrangement is an Other Payer Advanced APM. Examples of such documentation would include contracts and other relevant documents that govern the other payer arrangement that verify each required information element, copies of their full contracts governing the arrangement, or some other documents that detail and govern the payment arrangement. In addition to requesting that we determine whether one or more other payer arrangements are Other Payer Advanced APMs for the year, APM Entities or eligible clinicians may also inform us that they are participating in an other payer arrangement that we determine to be an Other Payer Advanced APM for the year. To do so, we proposed that an APM Entity or eligible clinician would indicate, upon submission of Other Payer Advanced APM participation data for purposes of QP determinations, which Other Payer Advanced APMs they participated in during the QP Performance Period, and include copies of participation agreements or similar contracts (or relevant portions of them) to document their participation in those payment arrangements.
We acknowledged that there is some burden associated with requesting Other Payer Advanced APM determinations. We sought comment on ways to reduce burden on states, payers, APM Entities, and eligible clinicians while still allowing us to receive the information necessary to make such determinations.
We received no comments in response to these proposals.
In the CY 2018 Quality Payment Program proposed rule, we believe that it is important that the information submitted by payers through the Payer Initiated Process is true, accurate, and complete. To that end, we proposed to add a new requirement at § 414.1445(d) stating that a payer that submits information pursuant to § 414.1445(c) must certify to the best of its knowledge that the information it submitted to us through the Payer Initiated Process is true, accurate, and complete. Additionally, we proposed that this certification must accompany the Payer Initiated Submission Form and any supporting documentation that payers submit to us through the Payer Initiated Process (82 FR 30195).
We proposed to revise and clarify the monitoring and program integrity provisions at § 414.1460. First, we proposed to modify § 414.1460(c) to specify that information submitted by payers for purposes of the All-Payer Combination Option may be subject to audit by us. We anticipate that the purpose of any such audit would be to verify the accuracy of an Other Payer Advanced APM determination. We sought comment on how this might be done with minimal burden to payers. Second, we proposed at § 414.1460(e)(1) to require payers who choose to submit information through the Payer Initiated Process to maintain such books, contracts, records, documents, and other evidence as necessary to audit an Other Payer Advanced APM determination. We proposed that such information must be maintained for 10 years after submission. We also proposed at § 414.1460(e)(3) that such information and supporting documentation must be provided to us upon request. We requested comments on this proposal, including comment on the length of time payers typically maintain such information. We also sought comment on how this might be done with minimal burden to payers.
The following is a summary of the public comments received on these proposals and our responses:
In the CY 2017 Quality Payment Program final rule, we finalized a requirement at § 414.1445(b)(3) that payers must attest to the accuracy of information submitted by eligible clinicians (81 FR 77480). After publication of the CY 2017 Quality Payment Program final rule, we received comments from stakeholders opposing this requirement. Commenters suggested that payers may not have any existing relationship with us, that payers do not have any direct stake in the QP status of eligible clinicians, and that there may be operational and legal barriers to payers attesting to this information. In consideration of these comments, in the CY 2018 Quality Payment Program proposed rule, we proposed to eliminate the requirement at § 414.1445(b)(3) that payers attest that the information submitted by eligible clinicians is accurate. Instead, we proposed that payers must certify the truth, accuracy, and completeness of only the information they submit directly to us (82 FR 30195).
In the CY 2017 Quality Payment Program final rule, we finalized a requirement at § 414.1460(c) that eligible clinicians and APM Entities must attest to the accuracy and completeness of data submitted to meet the requirements under the All-Payer Combination Option. We believe this requirement would be more appropriately placed in the regulatory provisions that discuss the submission of information related to requests for Other Payer Advanced APM determinations. Accordingly, we proposed to remove this requirement at § 414.1460(c) and proposed at § 414.1445(d) that an APM Entity or eligible clinician that submits information under § 414.1445(c) must certify to the best of its knowledge that the information it submitted to us is true, accurate, and complete. In the case of information submitted by the APM Entity, we proposed that the certification be made by a person with the authority to bind the APM Entity. We also proposed that this certification accompany the Eligible Clinician Initiated Submission Form and any supporting documentation that eligible clinicians submit to us through this process. We noted that under § 414.1460(c), APM Entities or eligible clinicians may be subject to audit of the information and supporting documentation provided under the certification. We also proposed to add a similar certification requirement at § 414.1440(f)(2) for QP determinations. We noted that we proposed to remove the last sentence of § 414.1460(c) regarding record retention and address the record retention issue only in the maintenance of records provision at § 414.1460(e).
Finally, we proposed to clarify the nature of the information subject to the record retention requirements at § 414.1460(e). Specifically, we proposed that an APM Entity or eligible clinician must maintain such books, contracts, records, documents, and other evidence as necessary to enable the audit of an Other Payer Advanced APM determination, QP determination, and the accuracy of an APM Incentive Payment.
The following is a summary of the public comments received on these proposals and our responses:
In the CY 2017 Quality Payment Program final rule, we finalized at § 414.1420(c)(3) that to meet the quality measure use criterion to be an Other Payer Advanced APM, the other payer arrangement must use an outcome measure if there is an applicable outcome measure on the MIPS quality measure list; but if there is no outcome measure available for use in the other payer arrangement, the APM Entity must attest that there is no applicable measure on the MIPS quality measure list. While we did not propose substantive changes to this policy in the CY 2018 Quality Payment Program proposed rule, we did propose technical revisions to our regulations to codify this policy at § 414.1445(c)(3) and we clarify that a payer, APM entity, or eligible clinician must certify that there is no applicable measure on the MIPS quality measure list if the payment arrangement does not use an outcome measure.
The following is a summary of the public comments received on this proposal and our responses:
In the CY 2018 Quality Payment Program proposed rule, we noted that we intend to post, on the CMS Web site, only the following information about other payer arrangements that we determine are Other Payer Advanced APMs: The names of payers with Other Payer Advanced APMs as specified in either the Payer Initiated or Eligible Clinician Initiated Submission Form, the location(s) in which the Other Payer Advanced APMs are available whether at the nationwide, state, or county level, and the names of the specific Other Payer Advanced APMs (82 FR 30196).
We explained that we believe that making this information publicly available is particularly important for Medicaid APMs and Medicaid Medical Home Models determined to meet the Other Payer Advanced APM criteria so that eligible clinicians can assess whether their Medicaid payments and patients would be excluded in calculations under the All-Payer Combination Option. More generally, we believe that making this information publicly available would help eligible clinicians to identify which of their other payer arrangements are Other Payer Advanced APMs so they can include information on those Other Payer Advanced APMs in their requests for QP determinations; and to learn about, and potentially join, Other Payer Advanced APMs that may be available to them. We sought comment on whether posting this information would be helpful to APM Entities or eligible clinicians.
In the CY 2017 Quality Payment Program final rule, we finalized that, to the extent permitted by federal law, we would maintain confidentiality of certain information that APM Entities or eligible clinicians submit for purposes of Other Payer Advanced APM determinations to avoid dissemination of potentially sensitive contractual information or trade secrets (81 FR 77478-77480).
In the CY 2018 Quality Payment Program proposed rule, we proposed that, with the exception of the specific information we proposed to make publicly available as stated above, the information a payer submits to us through the Payer Initiated Process and the information an APM Entity or eligible clinician submits to us through the Eligible Clinician Initiated Process would be kept confidential to the extent permitted by federal law, in order to avoid dissemination of potentially sensitive contractual information or trade secrets.
We sought comment on this proposal.
The following is a summary of the public comments received on this proposal and our responses:
Some commenters requested that CMS clarify whether any of the information that is required to be submitted would be subject to disclosure under the Freedom of Information Act (FOIA), and several commenters requested that CMS clarify that this information would be predesignated as falling under a FOIA exemption, either under Exemption 4 or Exemption 5 of FOIA.
Additionally, we note that records that a submitter marks as confidential will be protected from disclosure to the extent permitted by federal law. Specifically, Exemption 4 of the Freedom of Information Act (FOIA) authorizes us to withhold trade secrets and commercial or financial information obtained from a person and privileged or confidential. (45 CFR 5.31(d)). A person who submits records to the government may designate part or all of the information in such records that they may consider to be exempt from disclosure under Exemption 4 of the FOIA. The person may make this designation either at the time the records are submitted to the government or within a reasonable time thereafter. The designation must be in writing. Any such designation will expire 10 years after the records were submitted to the government. (45 CFR 5.41). If records provided by a submitter become the subject of a FOIA request, the agency will engage the submitter in the pre-disclosure notification process, unless the agency determines that the information should be withheld, or the designation of “confidential” appears obviously frivolous. The pre-disclosure notification process can be found at 45 CFR 5.42.
In the CY 2017 Quality Payment Program final rule, we finalized that to be an Other Payer Advanced APM, the other payer arrangement must require at least 50 percent of participating eligible clinicians in each APM Entity to use CEHRT to document and communicate clinical care (81 FR 77465).
In the CY 2018 Quality Payment Program proposed rule, we stated that we believe that some other payer arrangements, particularly those for which eligible clinicians may request determinations as Other Payer Advanced APMs, may only require CEHRT use at the individual eligible clinician level in the contract the eligible clinician has with the payer. We also believe that it may be challenging for eligible clinicians to submit information sufficient for us to determine that at least 50 percent of eligible clinicians under the other payer arrangement are required to use CEHRT to document and communicate clinical care (82 FR 30196).
To address this issue, we proposed that we would presume that an other payer arrangement would satisfy the 50 percent CEHRT use criterion if we receive information and documentation from the eligible clinician through the Eligible Clinician Initiated Process showing that the other payer arrangement requires the requesting eligible clinician(s) to use CEHRT to document and communicate clinician information. We sought comment on this proposal. We also sought comment on what kind of requirements for CEHRT currently exist in other payer arrangements, particularly if they are written to apply at the eligible clinician level.
The following is a summary of the public comments received on this proposal and our responses:
In summary, we are finalizing the following policies:
• We are finalizing our proposal to allow certain other payers, including payers with payment arrangements authorized under Title XIX, Medicare Health Plan payment arrangements, and payers with payment arrangements aligned with a CMS Multi-Payer Model to request that we determine whether their other payer arrangements are Other Payer Advanced APMs starting prior to the 2019 QP Performance Period and each year thereafter. We are finalizing our proposal to allow remaining other payers, including commercial and other private payers, to request that we determine whether other payer arrangements are Other Payer Advanced APMs starting in 2019 prior to the 2020 QP Performance Period, and annually each year thereafter. We will generally refer to this process as the Payer Initiated Other Payer Advanced APM Determination Process (Payer Initiated Process), and we are finalizing our proposal that the Payer Initiated Process would generally involve the same steps for each payer type for each QP Performance Period. If a payer uses the same other payer arrangement in other commercial lines of business, we are finalizing our proposal to allow the payer to concurrently request that we determine whether those other payer arrangements are Other Payer Advanced APMs as well. We are codifying these policies at §§ 414.1445(a) and 414.1445(b)(1).
• We are finalizing our proposal that Other Payer Advanced APM determinations would be in effect for only one year at a time.
• We are finalizing our proposal that the Payer Initiated Process would be voluntary for all payers.
• We are finalizing our proposal that payers would be required to use the Payer Initiated Submission Form to request that we make an Other Payer Advanced APM determination. We are finalizing our proposal that the Submission Period opening date and Submission Deadline would vary by payer type to align with existing CMS processes for payment arrangements authorized under Title XIX, Medicare Health Plan payment arrangements, and payers with payment arrangements aligned with a CMS Multi-Payer Model to the extent possible and appropriate.
• We are finalizing that, if we determine that the payer has submitted incomplete or inadequate information, we would inform the payer and allow the payer to submit additional information no later than 15 business days from the date we inform the payer. For each other payer arrangement for which the payer does not submit sufficient information, we would not make a determination in response to that request submitted via the Payer Initiated Submission Form.
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• We are finalizing our proposal that through the Eligible Clinician Initiated Process, APM Entities and eligible clinicians participating in other payer arrangements would have an opportunity to request that we determine for the year whether those other payer arrangements are Other Payer Advanced APMs. We are finalizing our proposal that through the Eligible Clinician Initiated Process, APM Entities and eligible clinicians participating in other payer arrangements would have an opportunity to request that we determine for the year whether those other payer arrangements are Other Payer Advanced APMs. The Eligible Clinician Initiated Process could be used to request determinations before the beginning of an QP Performance Period for other payer arrangements authorized under Title XIX. We are codifying these policies at §§ 414.1445(a) and 414.1445(b)(2).
• We are finalizing our proposal that APM Entities or eligible clinicians would be required to use the Eligible Clinician Initiated Submission Form to request that we make an Other Payer Advanced APM determination.
• We are finalizing our proposal that if we determine that the APM Entity or eligible clinician has submitted incomplete or inadequate information, we would inform the payer and allow the payer to submit additional information no later than 15 business days from the date we inform the APM Entity or eligible clinician. For each other payer arrangement for which the APM Entity or eligible clinician does not submit sufficient information, we would not make a determination in response to that request submitted via the Eligible Clinician Initiated Submission Form.
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• We are finalizing that, for each other payer arrangement for which a payer requests that we make an Other Payer Advanced APM determination, all payers must complete and submit the
• We are finalizing our proposal that, for each other payer arrangement an APM Entity or eligible clinician requests us to determine whether it is an Other Payer Advanced APM, all APM Entities or eligible clinicians must complete and submit the Eligible Clinician Initiated Submission Form by the relevant Submission Deadline. We are finalizing that the Eligible Clinician Initiated Submission Form would allow APM Entities or eligible clinicians to include descriptive language for each of the required information elements. We are finalizing our proposal to require the name and description of the arrangement, nature of the arrangement, QP Performance Period for which the arrangement is available, participant eligibility criteria, and location(s) where the arrangement will be available so that we can verify whether eligible clinicians who may tell us that they participate in such arrangements are eligible to do so. We are finalizing our proposal to require that APM Entities or eligible clinicians submit documentation that supports the information they provided in the Eligible Clinician Initiated Submission Form and that is sufficient to enable us to determine whether the other payer arrangement is an Other Payer Advanced APM.
• We are finalizing our proposal that, for each other payer arrangement a payer requests us to determine whether it is an Other Payer Advanced APM, the payer must complete and submit the Payer Initiated Submission Form by the relevant Submission Deadline.
• We are finalizing our proposal that, for each other payer arrangement an APM Entity or eligible clinician requests us to determine whether it is an Other Payer Advanced APM, the APM Entity or eligible clinician must complete and submit the Eligible Clinician Initiated Submission Form by the relevant Submission Deadline.
• We are finalizing our proposal to add a new requirement at § 414.1445(d) stating that a payer that submits information pursuant to § 414.1445(c) must certify to the best of its knowledge that the information submitted to us through the Payer Initiated Process is true, accurate, and complete. Additionally, we are finalizing that this certification must accompany the Payer Initiated Submission Form and any supporting documentation that payers submit to us through this process.
• We are finalizing our proposed revisions to the monitoring and program integrity provisions at § 414.1460 to ensure the integrity of the Payer Initiated Process. Specifically, we are requiring payers that choose to submit information through the Payer Initiated Process to maintain such books, contracts, records, documents, and other evidence as necessary to enable the audit of an Other Payer Advanced APM determination and that such information and supporting documentation must be maintained for a period of 6 years after submission and must be provided to CMS upon request. We are also finalizing our proposal to specify that information submitted by payers for purposes of the All-Payer Combination Option may be subject to audit by CMS.
• We are removing the requirement at § 414.1445(b)(3) that payers must attest to the accuracy of information submitted by eligible clinicians, and we are also removing the attestation requirement at § 414.1460(c). Instead, we are finalizing our proposal to add a requirement at § 414.1445(d) that an APM Entity or eligible clinician that submits information pursuant to § 414.1445(c) must certify to the best of its knowledge that the information it submitted to us is true, accurate, and complete. We are also finalizing that this certification must accompany the submission, and in the case of information submitted by an APM Entity, the certification must be made by an individual with the authority to bind the APM Entity.
• We are removing the record retention requirement at § 414.1445(c) and in this final rule with comment period, we only address the record retention requirements for Other Payer Advanced APM determinations at § 414.1460(e)(1). We are finalizing that an APM Entity and eligible clinician that submits information to us under § 414.1445 for assessment under the All-Payer Combination Option must maintain such books, contracts, records, documents, and other evidence as necessary to enable the audit of an Other Payer Advanced APM determination for a period of 6 years from the end of the QP Performance Period or from the date of completion of any audit, evaluation, or inspection, whichever is later.
• We are finalizing that, with the exception of the specific information we propose to make publicly available as stated above, the information a payer submits to us through the Payer Initiated Process and the information an APM Entity or eligible clinician submits to us through the Eligible Clinician Initiated Process would be kept confidential to the extent permitted by federal law.
• We are finalizing our proposal to presume that an other payer arrangement would satisfy the 50 percent CEHRT use criterion if we receive information and documentation from the APM Entity or eligible clinician through the Eligible Clinician Initiated Process showing that the other payer arrangement requires the requesting eligible clinician or those in the requesting APM Entity to use CEHRT to document and communicate clinical information.
In the CY 2017 Quality Payment Program final rule, we finalized our overall approach to the All-Payer Combination Option (81 FR 77463). Beginning in 2021, in addition to the Medicare Option, an eligible clinician may alternatively become a QP through the All-Payer Combination Option, and an eligible clinician need only meet the QP threshold under one of the two options to be a QP for the payment year (81 FR 77459). We finalized that we will conduct the QP determination sequentially so that the Medicare Option is applied before the All-Payer Combination Option (81 FR 77439).
We finalized that we will calculate Threshold Scores under the Medicare Option through both the payment amount and patient count methods, compare each Threshold Score to the relevant QP and Partial QP Thresholds, and use the most advantageous score to make QP determinations (81 FR 77457). We finalized the same approach for the All-Payer Combination Option (81 FR 77475).
In the CY 2018 Quality Payment Program proposed rule, we proposed the following policies:
• We proposed to establish the All-Payer QP Performance Period, which would begin on January 1 and end on June 30 of the calendar year that is 2 years prior to the payment year. We proposed to add the term All-Payer QP Performance Period to § 414.1305.
• We proposed to make QP determinations based on individual eligible clinicians' participation in Advanced APMs and Other Payer Advanced APMs for 2 time periods: Between January 1 through March 31 and between January 1 through June 30 of the All-Payer QP Performance Period under the All-Payer Combination Option. We proposed to use data for the same time periods for Medicare payments or patients and that of other payers. We also proposed that in order for us to make a QP determination for an individual eligible clinician under the All-Payer Combination Option, the individual eligible clinician must request it and must submit payment amount and patient count data from other payers to support the QP determination.
• We proposed to notify eligible clinicians of their QP status under the All-Payer Combination Option as soon as practicable after the proposed QP Determination Submission Deadline.
• We proposed to make QP determinations under the All-Payer Combination Option at the individual eligible clinician level only.
• We proposed to use the individual eligible clinician payment amounts and patient counts for Medicare in the All-Payer Combination Option. We proposed that when an individual eligible clinician's Medicare Threshold Score calculated at the individual eligible clinician level would be a lower percentage than the one that is calculated at the APM Entity group level, we would apply a weighting methodology.
• We proposed that we will determine whether a state operates a Medicaid APM or a Medicaid Medical Home Model that has been determined to be an Other Payer Advanced APM at a sub-state level. We proposed that we will use the county level to determine whether a state operates a Medicaid APM or a Medicaid Medical Home Model that meets the Other Payer Advanced APM at a sub-state level.
• We proposed that in a state where we determine there are one or more Medicaid APMs or Medicaid Medical Home Models that are Other Payer Advanced APMs in operation, but only in certain counties, or only for eligible clinicians in certain specialties, we would further evaluate whether those Medicaid APMs or Medicaid Medical Home Models were available to each eligible clinician for whom we make a QP determination under the All-Payer Combination Option. We would identify the county in which the eligible clinician practices by having the individual eligible clinician submit information so we can identify the county where an individual eligible clinician saw the most patients during the relevant QP Performance Period when they request a QP determination. We also proposed that if the eligible clinician's practice is in a county or in a specialty in which there is no Medicaid APM or Medicaid Medical Home Model in operation, all of that eligible clinician's Medicaid payments and patients would be excluded from the numerator and denominator of the calculations under the payment amount or patient count method, respectively.
• We proposed to first make a calculation under the Medicare Option using all Medicare payments for the APM Entity for the payment amount method. If the minimum threshold score for the Medicare Option were met, we would make calculations under the All-Payer Combination Option. Because we proposed to make QP determinations at the individual eligible clinician level only, we proposed that under the All-Payer Combination Option the numerator would be the aggregate of all payments from all payers, except those excluded, that are made or attributable to the eligible clinician, under the terms of all Advanced APMs and Other Payer Advanced APMs. We also proposed that the denominator would be the aggregate of all payments from all payers, except those excluded, that are made or attributed to the eligible clinician.
• Because we proposed to make QP determinations at the individual eligible clinician level only, we proposed to count each unique patient one time in the numerator and one time in the denominator across all payers to align with our finalized policy for patient counts at the eligible clinician level for the patient count method under the All-Payer Combination Option. We proposed that the numerator would be the number of unique patients the eligible clinician furnishes services to under the terms of all of their Advanced APMs or Other Payer Advanced APMs. We proposed that the denominator would be the number of unique patients the eligible clinician furnishes services to under all payers, except those excluded.
• We proposed to collect the necessary payment amount and patient count information for QP determinations under the All-Payer Combination Option aggregated for the two proposed snapshot timeframes: From January 1 through March 31 and from January 1 through June 30. We proposed that APM Entities may submit this information on behalf of any of the eligible clinicians in the APM Entity group at the individual eligible clinician level. If an APM Entity or eligible clinician submits sufficient information for either the payment amount or patient count method, but not for both, we proposed to make a QP determination based on the one method for which we receive sufficient information.
• We proposed that APM Entities or eligible clinicians must submit all of the required information about the other payer arrangements in which they participate, including those for which there is a pending request for an Other Payer Advanced APM determination, as well as the payment amount and patient count information sufficient for us to make QP determinations by December 1 of the calendar year that is 2 years to prior to the payment year, which we refer to as the QP Determination Submission Deadline.
• We proposed that an APM Entity or eligible clinician who submits information to request a QP determination under the All-Payer Combination Option must certify to the best of their knowledge that the information submitted is true, accurate and complete. When this information is submitted by an APM Entity, we proposed that the certification be made by an individual with the authority to bind the APM Entity. We also proposed that this certification must accompany the form that APM Entities or eligible clinicians submit to us when requesting that we make QP determinations under the All-Payer Combination Option.
• We proposed that APM Entities and eligible clinicians who submit information to us under § 414.1445 for assessment under the All-Payer Combination Option or § 414.1440 for QP determinations under the All-Payer Combination Option must maintain such books, contracts, records, documents, and other evidence as necessary to enable the audit of an Other Payer Advanced APM determination, QP determinations, and the accuracy of APM Incentive Payments for a period of 10 years from the end of the QP Performance Period or from the date of completion of any audit, evaluation, or inspection, whichever is later.
• We proposed that APM Entities and eligible clinicians who submit information to us under § 414.1445 or § 414.1440 must provide such information and supporting documentation to us upon our request.
• We proposed that, to the extent permitted by federal law, we will maintain confidentiality of the information that APM Entities or eligible clinicians submit to us for purposes of QP determinations under the All-Payer Combination Option, to avoid dissemination of potentially sensitive contractual information or trade secrets.
• We proposed that eligible clinicians who are Partial QPs for the year under the All-Payer Combination Option would make the election whether to report to MIPS.
In the CY 2018 Quality Payment Program proposed rule, we proposed to establish a separate QP Performance Period for the All-Payer Combination Option, which would begin on January 1 and end on June 30 of the calendar year that is 2 years prior to the payment year. We proposed to define this term in § 414.1305 as the All-Payer QP Performance Period. We also proposed that the QP Performance Period for the Medicare Option would remain the same as previously finalized, so it would begin on January 1 and end on August 31 of the calendar year that is 2 years to the payment year. We proposed to define this term in § 414.1305 as the Medicare QP Performance Period (82 FR 30171).
We explained that we proposed to establish the All-Payer QP Performance Period because, to make QP determinations under the All-Payer Combination Option, we first need to collect information on eligible clinicians' payments and patients with all other payers. And, in order to provide eligible clinicians with timely QP determinations that would enable them to make their own timely decisions for purposes of MIPS based on their QP status for the year, we need to collect this information by December 1 of the QP performance year. We expressed concern that eligible clinicians would not be able to submit the necessary payment and patient information from all of their other payers for the period from January 1 through August 31 before the December 1 QP Determination Submission Deadline. For the Medicare Option, we allow for a 90-day claims run out period before gathering the necessary payment amount and patient count information. We stated that we believe the same claims run out timeframe should be adopted for other payers, and that if we were to maintain the current QP Performance Period through August 31, eligible clinicians would be required to submit their other payer payment and patient information to us on or very near the end of the 90 day claims run out period, leaving them with little or no time to prepare the submission. We also stated that we believe that an additional 60 days after the claims run out is a reasonable amount of time for the eligible clinician to collect and submit the payment and patient data. We sought comment on this proposal, specifically as to an appropriate claims run out standard for other payers.
We noted that if we retained the current QP Performance Period and instead delayed the QP Determination Submission Deadline to allow eligible clinicians time comparable to the time provided under the Medicare Option to fully collect and submit this information, QP determinations under the All-Payer Combination Option would likely not be complete before the end of the MIPS reporting period, which would undermine our goal of giving eligible clinicians information about their QP status prior to the end of the MIPS reporting period.
Alternatively, we considered whether to establish the All-Payer QP Performance Period from January 1 through March 31 of the calendar year that is 2 years prior to the payment year. We sought comment on this alternative.
In the CY 2018 Quality Payment Program proposed rule, consistent with our proposal to make the All-Payer QP Performance Period from January 1 through June 30 of the calendar year that is 2 years prior to the payment year, we proposed to make QP determinations based on eligible clinicians' participation in Advanced APMs and Other Payer Advanced APMs between January 1 through March 31 and January 1 through June 30 under the All-Payer Combination Option. We also proposed that an eligible clinician would need to meet the relevant QP or Partial QP Threshold under the All-Payer Combination Option, and we would use data for the same time periods for Medicare payments or patients and that of other payers. We also proposed to align the time period assessed for the Medicare and other payer portions of the calculations under the All-Payer Combination Option because we believe that would support the principle that QP determinations should be based on an eligible clinician's performance over a single period of time (82 FR 30199 through 30200).
We sought comment on our proposal to create the All-Payer QP Performance Period and our proposals regarding alignment between time periods assessed under the Medicare Option and the All-Payer Combination Option. The following is a summary of the public comments received on these proposals and our responses:
As we do for the Medicare Option, we will make QP determinations based on three snapshot dates: March 31, June 30, and August 31. We are finalizing our proposal that an eligible clinician would need to meet the relevant QP or Partial QP threshold under the All-Payer Combination Option as of one of these three dates, and to use data for the same time periods for Medicare and other payer payments or patients in making QP determinations. We recognize that it may be challenging for some eligible clinicians to submit data for the third snapshot, and in the event that an eligible clinician or APM Entity submits only information for either of the first two snapshots, we will make QP determinations on that basis. We are codifying this policy at § 414.1440(e)(3).
In the CY 2018 Quality Payment Program proposed rule, we explained that we believe it is important to provide eligible clinicians as much information as possible about their QP status under the Medicare Option prior to the proposed QP Determination Submission Deadline.
We also believe that it is important to give eligible clinicians as much time as possible to prepare for MIPS reporting if necessary. We therefore proposed to inform eligible clinicians of their QP status under the All-Payer Combination Option as soon as practicable after the proposed QP Determination Submission Deadline (82 FR 30200).
We sought comment on this proposal. We received no comments in response to this proposal.
In the CY 2017 Quality Payment Program final rule, we finalized that, similar to the Medicare Option, we will calculate the Threshold Scores used to make QP determinations under the All-Payer Combination Option at the APM Entity group level unless certain exceptions apply (81 FR 77478).
In the CY 2018 Quality Payment Program proposed rule, we proposed to modify this policy and make QP determinations under the All-Payer Combination Option at the individual eligible clinician level only. We stated that we believe that there would be significant challenges associated with making QP determinations under the All-Payer Combination Option at the APM Entity group level as we finalized in the CY 2017 Quality Payment Program final rule (82 FR 30200).
As we explained in the CY 2017 Quality Payment Program final rule, an APM Entity generally 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 APM Entity group level as determined by the Advanced APM. We note that there are certain exceptions for QP determinations, specified in § 414.1425(b)(1), for eligible clinicians on Affiliated Practitioner Lists. In light of these exceptions, we noted that we believe it is generally preferable to make QP determinations at the APM Entity level unless we are making QP determinations for eligible clinicians identified on Affiliated Practitioner Lists as specified at § 414.1425(b)(1); or we are making QP determinations for eligible clinicians participating in multiple APM Entities, none of which reach the QP Threshold as a group as specified at § 414.1425(c)(4) (81 FR 77439).
However, under the All-Payer Combination Option, in the CY 2018 Quality Payment Program proposed rule, we explained that we believe in many instances that the eligible clinicians in the APM Entity group we would identify and use to make QP determinations under the Medicare Option would likely have little, if any, common APM Entity group level participation in Other Payer Advanced APMs. The eligible clinicians in the same APM Entity group would not necessarily have agreed to share risks and rewards for Other Payer Advanced APM participation as an APM Entity group, particularly when eligible clinicians may participate in Other Payer Advanced APMs at different rates within an APM Entity group (or not at all).
We also discussed our concern that eligible clinicians may participate in Other Payer Advanced APMs whose participants do not completely overlap, or do not overlap at all, with the APM Entity the eligible clinician is part of. Therefore, we noted that we believe that looking at participation in Other Payer Advanced APMs at the individual eligible clinician level may be a more meaningful way to assess their participation across multiple payers. In addition, those risks and rewards associated with participation in Other Payer Advanced APMs may vary significantly among eligible clinicians depending on the Other Payer Advanced APMs in which they participate. Specifically, we expressed concern that if we were to make All-Payer Combination Option QP determinations at the APM Entity level, the denominator in QP threshold calculations could include all other payments and patients from eligible clinicians who had no, or limited, Other Payer Advanced APM participation, thereby disadvantaging those eligible clinicians who did have significant Other Payer Advanced APM participation. By contrast, this scenario is unlikely to occur when making QP determinations at the APM Entity level under the Medicare Option because all eligible clinicians in the APM Entity group would be contributing to the APM Entity's performance under the Advanced APM. For these reasons, we stated that we believe it would be most appropriate to make all QP determinations under the All-Payer Combination Option at the individual eligible clinician level (82 FR 30200).
We sought comment on this proposal, specifically on the possible extent to which APM Entity groups in Advanced APMs could agree to be assessed collectively for performance in Other Payer Advanced APMs. We also sought comment on whether there is variation, and the extent of that variation, among eligible clinicians within an APM Entity group in their participation in other payer arrangements that we may determine to be Other Payer Advanced APMs. We sought comment on whether there are circumstances in which QP determinations should be made at the APM Entity group level under the All-Payer Combination Option.
We also sought comment on whether APM Entities in Other Payer Advanced APMs could report this information at the APM Entity group level to facilitate our ability to make QP determinations at the APM Entity group level.
The following is a summary of the public comments received on our proposal and our responses:
In the event that we receive a request for QP determination from an individual eligible clinician and also separately receive a QP determination request from that individual eligible clinician's APM Entity, we would make a determination at both levels. The eligible clinician could become a QP on the basis of either of the two determinations.
We are also requesting comments on whether in future rulemaking we should also add a third alternative to allow QP determinations at the TIN level when all clinicians who have reassigned billing to the TIN are included in a single APM Entity. In particular, we are interested in whether submitting information to request QP determinations under the All-Payer Combination Option at the TIN level would more closely align with eligible clinicians' existing recordkeeping practices, and thereby be less burdensome.
In the CY 2018 Quality Payment Program proposed rule, we noted that when an Affiliated Practitioner List defines the eligible clinicians to be assessed for QP determination in the Advanced APM, we make QP determinations under the Medicare Option at the individual level only. As such, we proposed that even if we did not finalize our proposal to conduct assessments under the All-Payer Combination Option at the individual eligible clinician level only, and instead adopted a mechanism to make QP determinations under the All-Payer Combination Option at the APM Entity group level, we would nonetheless assess eligible clinicians who meet the criteria to be assessed individually under the Medicare Option at the individual level only under the All-Payer Combination Option (82 FR 30201).
We sought comment on this proposal. We received no comments in response to this proposal.
In the CY 2018 Quality Payment Program proposed rule, we explained that because we proposed to make QP determinations at the individual eligible clinician level only, we proposed to use the individual eligible clinician payment amounts and patient counts for the Medicare calculations in the All-Payer Combination Option. We noted that we believe that matching the information we use at the same level for all payment amounts and patient counts for both the Medicare and other payer portions of the calculations under the All-Payer Combination Option is most consistent with sections 1833(z)(2)(B)(ii) and (C)(ii) of the Act because these provisions require calculations that add together the payments or patients from Medicare and all other payers (except those excluded).
We noted, however, that we would use the APM Entity group level payment amounts and patient counts for all Medicare Option Threshold Scores, unless we are making QP determinations for Affiliated Practitioner Lists as specified at § 414.1425(b)(1) or we are making QP determinations for eligible clinicians participating in multiple APM Entities, none of which reach the QP Threshold as a group as specified at § 414.1425(c)(4) (82 FR 30201).
We sought comment on this proposal. We received no comments in response to this proposal.
In the CY 2018 Quality Payment Program proposed rule, we explained that we recognize that in many cases an individual eligible clinician's Medicare Threshold Scores would likely differ from the corresponding Threshold Scores calculated at the APM Entity group level, which would benefit those eligible clinicians whose individual Threshold Scores would be higher than the group Threshold Scores and disadvantage those eligible clinicians whose individual Threshold Scores are equal to or lower than the group Threshold Scores. In situations where eligible clinicians are assessed under the Medicare Option as an APM Entity group, and receive a Medicare Threshold Score at the group level, we believe that the Medicare portion of their All-Payer Combination Option should not be lower than the Medicare Threshold Score that they received by participating in an APM Entity group (82 FR 30201).
To accomplish this outcome, we proposed a modified methodology. We proposed that when the eligible clinician's Medicare Threshold Score calculated at the individual level would be a lower percentage than the one that is calculated at the APM Entity group level we would apply a weighting methodology. This methodology would allow us to apply the APM Entity group level Medicare Threshold Score (if higher than the individual eligible clinician level Medicare Threshold Score), to the eligible clinician, under either the payment amount or patient count method, but weighted to reflect the individual eligible clinician's Medicare volume.
We would multiply the eligible clinician's APM Entity group Medicare Threshold Score by the total Medicare payments or patients made to that eligible clinician as follows:
As an example of how this weighting methodology would apply under the payment amount method for payment year 2021, consider the following APM Entity group with two clinicians, one of whom participates in Other Payer Advanced APMs and one who does not.
In this example, the APM Entity group Medicare Threshold Score is $300/$1000, or 30 percent. Eligible Clinicians A and B would not be QPs under the Medicare Option, but Clinician B could request that we make a QP determination at the individual eligible clinician level under the All-Payer Combination Option since the APM Entity group Threshold Score exceeded the 25 percent minimum Medicare payment amount QP Threshold under the Medicare Option.
When we calculate Clinician B's payments individually, we would calculate the Threshold Score as follows:
Because Clinician B's Threshold Score is less than the 50 percent QP Payment Amount Threshold, Clinician B would not be a QP based on this result. However, if we apply the weighting methodology, we would calculate the Threshold Score as follows:
Based upon this Threshold Score, Clinician B would be a QP under the All-Payer Combination Option for the year.
We would calculate the eligible clinician's Threshold Scores both individually and with this weighting methodology, and then use the more advantageous score when making a QP determination. We noted that we believe that this approach promotes consistency between the Medicare Option and the All-Payer Combination Option to the extent possible. We sought comment on this proposal.
The following is a summary of the public comments received on this proposal and our responses:
Sections 1833(z)(2)(B)(ii)(I)(bb) and 1833(z)(2)(C)(ii)(I)(bb) of the Act direct us to exclude payments made under Title XIX in a state where no Medicaid Medical Home Model or Medicaid APM is available under that state program. To carry out this exclusion, in the CY 2017 Quality Payment Final Rule, we finalized that for both the payment amount and patient count methods, Title XIX payments or patients will be excluded from the numerator and denominator for the QP determination unless:
(1) A state has in operation at least one Medicaid APM or Medicaid Medical Home Model that is determined to be an Other Payer Advanced APM; and
(2) The relevant 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 (81 FR 77475).
For purposes of the discussion below on the exclusion of Title XIX payments and patients in QP determinations, we note that when we refer to Medicaid Medical Home Models, we are referring to those that are Other Payer Advanced APMs. We also discussed that if a state operates such an Other Payer Advanced APM at a sub-state level such that eligible clinicians who do not practice in the area are not eligible to participate, Medicaid payments or patients should not be included in those eligible clinicians' QP calculations because no Medicaid Medical Home Model or Medicaid APM was available for their participation (81 FR 77475).
In the CY 2018 Quality Payment Program proposed rule, we proposed that we will use the county level to determine whether a state operates a Medicaid APM or a Medicaid Medical Home Model at a sub-state level. We noted that we believe that the county level is appropriate as in our experience, the county level is the most common geographic unit used by states when creating payment arrangements under Title XIX at the sub-state level. We explained that we believe that applying this exclusion at the county level would allow us to carry out this exclusion in accordance with the statute in a way that would not penalize eligible clinicians who have no Medicaid APMs or Medicaid Medical Home Models available to them (82 FR 30202). We sought comment on this proposal.
The following is a summary of the public comments received on this proposal and our responses:
In the CY 2018 Quality Payment Program proposed rule, we also proposed that, in states where a Medicaid APM or Medicaid Medical Home Model only exists in certain counties, we would exclude Title XIX data from an eligible clinician's QP calculations unless the county where the eligible clinician saw the most patients during the relevant QP Performance Period was a county where a Medicaid APM or Medicaid Medical Home Model was available. We would require eligible clinicians to identify and certify the county where they saw the most patients during the relevant QP Performance Period. If that county is not in a county where a Medicaid APM or Medicaid Medical Home Model was available during the Performance Period, then Title XIX payments would be excluded from the eligible clinician's QP calculations. We proposed this approach to ensure that, before including Title XIX payment or patient count information in calculating QP determinations, eligible clinicians have a meaningful opportunity to participate in a Medicaid APM or Medicaid Medical Home Model in a manner that would allow for both positive and negative contributions to their QP threshold score under the All-Payer Combination Option (82 FR 30202). We sought comment on this proposal.
The following is a summary of the public comments received on this proposal and our responses:
In addition to excluding payments based on county-level geography, we proposed to exclude Title XIX payments and patients from the QP determination calculation when the only Medicaid APMs and Medicaid Medical Home Models available in a given county are not available to the eligible clinician in question based on their specialty. We noted that we believe that this proposal is consistent with the statutory requirement to exclude Title XIX payment and patients from the calculations when no Medicaid APM or Medicaid Medical Home Model is available. In cases where participation in such a model is limited to eligible clinicians in certain specialties, we do not believe the Medicaid APM or Medicaid Medical Home Model would effectively be available to eligible clinicians who are not in those specialties. We therefore believe it would be inappropriate and inequitable to include Title XIX payments and patients in such eligible clinicians' QP determination calculations. We proposed to identify Medicaid APM or Medicaid Medical Home Models that are only open to certain specialties through questions requested of states in the Payer Initiated Process and of APM Entities and eligible clinicians in the Eligible Clinician Initiated Process. We would exclude Title XIX data from an eligible clinician's QP calculations unless the eligible clinician practiced under one of the specialty codes eligible to participate in a Medicaid APM or Medicaid Medical Home Model that was available in the county where the eligible clinician saw the most patients. We would use the method generally used in the Quality Payment Program to identify an eligible clinician's specialty or specialties (82 FR 30202 through 30203). We sought comment on these proposals.
The following is a summary of the public comments received on these proposals and our responses:
In the CY 2017 Quality Payment Program final rule, we finalized that we will calculate an All-Payer Combination Option Threshold Score for eligible clinicians in an APM Entity using the payment amount method (81 FR 77476-77477). We finalized that the numerator will be the aggregate of all payments from all payers, except those excluded, to the 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. We finalized that the denominator will be the aggregate of all payments from all payers, except excluded payments, to the APM Entity's eligible clinicians, or the eligible clinician in the event of an individual eligible clinician assessment during the QP Performance Period.
We finalized that we will calculate the Threshold Score by dividing the numerator value by the denominator value, which will result in a percent value Threshold Score. We will compare that Threshold Score to the relevant QP Payment Amount Threshold and the relevant Partial QP Payment Amount Threshold and determine the QP status of the eligible clinicians for the payment year (81 FR 77475).
In the CY 2018 Quality Payment Program proposed rule, we proposed to maintain the policies we finalized for the payment amount method as finalized, with some proposed modifications. We proposed these changes to facilitate the implementation of the payment amount method while providing eligible clinicians with some flexibility in choosing the timeframe for making QP determinations. To implement our proposal to make QP determinations at the eligible clinician level only, we proposed that the numerator would be the aggregate of all payments from all payers, except those excluded, attributable to the eligible clinician only, under the terms of all Advanced APMs and Other Payer Advanced APMs from either January 1 through March 31 or January 1 through
The following is a summary of the public comments received on these proposals our responses:
In the CY 2017 Quality Payment Program final rule, we finalized that the Threshold Score calculation for the patient count method would include patients for whom the eligible clinicians in an APM Entity furnish services and receive payment under the terms of an Other Payer Advanced APM, except for those excluded. We finalized that the numerator would be the number of unique patients to whom eligible clinicians in the APM Entity furnish services that are included in the aggregate expenditures used under the terms of all their Other Payer Advanced APMs during the QP Performance Period plus the patient count numerator for Advanced APMs. We finalized that the denominator would be the number of unique patients to whom eligible clinicians in the APM Entity furnish services under all payers, except those excluded. We finalized that we will calculate the Threshold Score by dividing the numerator value by the denominator value, which will result in a percent value Threshold Score. We will compare that Threshold Score to the finalized QP Patient Count Threshold and the Partial QP Patient Count Threshold and determine the QP status of the eligible clinicians for the payment year. We finalized that we would count each unique patient one time in the numerator and one time in the denominator (81 FR 77477-77478).
In the CY 2018 Quality Payment Program proposed rule, we explained that we intend to carry out QP determinations using the patient count method as finalized with some proposed modifications. We proposed these changes to facilitate the implementation of the patient count method while providing eligible clinicians with some flexibility in choosing the timeframe for making QP determinations. To implement the proposal to make QP determinations at the eligible clinician level only, we proposed to count each unique patient one time in the numerator and one time in the denominator across all payers to align with our finalized policy for patient counts at the eligible clinician level. We proposed that the numerator would be the number of unique patients the eligible clinician furnishes services to under the terms of all of their Advanced APMs or Other Payer Advanced APMs from either January 1 through March 31 or January 1 through June 30 of the QP Performance Period. We proposed that the denominator would be the number of unique patients the eligible clinician furnishes services to under all payers, except those excluded from either January 1 through March 31 or January 1 through June 30 of the QP Performance Period (82 FR 30203). We sought comment on these proposals.
The following is a summary of the public comments received on these proposals and our responses:
We acknowledge that some eligible clinicians may have a significant number of Medicare Advantage patients but furnish care to very few of them through an Other Payer Advanced APM with Medicare Advantage as a payer. In that case, the numerator may be significantly smaller than the denominator, and those eligible clinicians may not meet a QP Threshold. However, we do not believe there is any basis for making any special adjustment for this situation generally, nor do we believe it would be appropriate to treat Medicare Advantage differently from any other payer in this situation.
We are retaining the policies as they were finalized in the CY 2017 Quality Payment Program final rule (81 FR 77477-77478). Specifically, for each APM Entity, we would count each unique patient one time in the numerator and one time in the denominator. However, the same patient could be counted separately in the numerator and denominator of two separate payers (for example, Medicare and Medicaid for a dual eligible). Also, because we are retaining the January 1 through August 31 QP Performance Period for the All-Payer Combination Option, we will also have an August 31 snapshot date and thereby also make calculations based on the January 1 through August 31 time period. We are codifying our patient count method policy at § 414.1440(c).
In the CY 2017 Quality Payment Program final rule, we finalized that either 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 other payer arrangement is an Other Payer Advanced APM, including information on financial risk arrangements, use of CEHRT, and payment tied to quality measures; (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 number
In the CY 2018 Quality Payment Program proposed rule, we explained that in order for us to make QP determinations under the All-Payer Combination Option using either the payment amount or patient count method, we would need to receive all of the payment amount and patient count information: (1) Attributable to the eligible clinician through every Other Payer Advanced APM; and (2) for all other payments or patients, except from excluded payers, made or attributed to the eligible clinician during the QP Performance Period. We clarified that eligible clinicians will not need to submit Medicare payment or patient information for QP determinations under the All-Payer Combination Option.
In the CY 2018 Quality Payment Program proposed rule, we also noted that we will need this payment amount and patient count information from January 1 through June 30 of the calendar year 2 years prior to the payment year. We noted will need this payment amount and patient count information submitted in a way that allows us to distinguish information from January 1 through March 31 and from January 1 through June 30 so that we can make QP determinations based on the two proposed snapshot dates (82 FR 30203 through 30204).
We explained that to meet the need for information in a way that we believe minimizes reporting burden, we proposed to collect this payment amount and patient count information aggregated for the two proposed snapshot time frames: from January 1 through March 31 and from January 1 through June 30. We sought comment on this approach, particularly as to the feasibility of submitting information in this way and suggestions on how to further minimize reporting burden. We also explained that alternatively, if we finalized an All-Payer QP Performance Period of January 1 through March 31, we would need payment amount and patient count information only from January 1 through March 31. We noted that if we were to retain the current finalized QP Performance Period, we would need information aggregated for three snapshot timeframes: from January 1 through March 31, January 1 through June 30, and January 1 through August 31.
The following is a summary of the public comments received on this proposal and our responses:
Additionally, for the All-Payer Combination Option, we are concerned that adding a December 31 snapshot date will leave us unable to notify eligible clinicians of their QP status prior to the end of the MIPS reporting period, particularly because we would also need to move the QP Determination Submission Deadline to some time period after December 1.
In the CY 2018 Quality Payment Program proposed rule, we proposed that all of this payment and patient information must be submitted at the eligible clinician level, and not at the APM Entity group level as we finalized in rulemaking last year.
We sought comment on this proposal. We received no comments in response to this proposal.
In the CY 2018 Quality Payment Program proposed rule, to minimize reporting burden on individual eligible clinicians and to allow eligible clinicians to submit information to us as efficiently as possible, we proposed to
To facilitate and ease burden for information submissions, we also proposed to create a form that APM Entities or eligible clinicians would be able to use to submit this payment amount and patient count information. APM Entities and eligible clinicians would be required to use this form for submitting the payment and patient information.
We sought comment on these proposals.
The following is a summary of comments we received on these proposals and our responses:
We are also finalizing our proposal that if an APM Entity or eligible clinician submits sufficient information only for the payment amount or patient count method, but not for both, we will make a QP determination based on the one method for which we receive sufficient information. We are also finalizing our proposal to create a form that APM Entities or eligible clinicians would be able to use to submit this payment amount and patient count information.
In the CY 2018 Quality Payment Program proposed rule, we proposed that APM Entities or eligible clinicians must submit all of the required information about the Other Payer Advanced APMs in which they participate, including those for which there is a pending request for an Other Payer Advanced APM determination, as well as the payment amount and patient count information sufficient for us to make QP determinations by December 1 of the calendar year that is 2 years to prior to the payment year, which we refer to as the QP Determination Submission Deadline (82 FR 30204).
In the CY 2017 Quality Payment Program final rule, we finalized that without sufficient information we will not make QP determinations under the All-Payer Combination Option (81 FR 77480). As such, we will not make QP determinations for an eligible clinician under the All-Payer Combination Option if we do not receive information sufficient to make a QP determination under either the payment amount or patient count method by the QP Determination Submission Deadline.
We sought comment on this proposal.
The following is a summary of the public comments received on this proposal and our responses:
In the CY 2018 Quality Payment Program proposed rule, we proposed that a new requirement be added at § 414.1440(f)(2) stating that the APM Entity or eligible clinician that submits information to request a QP determination under the All-Payer Combination Option must certify to the best of its knowledge that the information that they submitted to us is true, accurate, and complete. If the information is submitted by an APM Entity, we proposed that the certification must be made by an individual with the authority to legally bind the APM Entity. This certification would accompany the Eligible Clinician Initiated Submission Form, which both eligible clinicians and APM Entities use for the Eligible Clinician Initiated Process (82 FR 30204). We sought comment on these proposals.
We proposed to revise the monitoring and program integrity provisions at § 414.1460 to further promote the integrity of the All-Payer Combination Option. In the CY 2017 Quality Payment Program final rule, we finalized at § 414.1460(e) that an APM Entity or eligible clinician that submits information to us under § 414.1445 for assessment under the All-Payer Combination Option must maintain such books contracts records, documents, and other evidence for a period of 10 years from the final date of the QP Performance Period or from the date of completion of any audit, evaluation, or inspection, whichever is later (81 FR 77555). We also finalized at § 414.1460(c) that eligible clinicians and APM Entities must maintain copies of any supporting documentation related to the All-Payer Combination Option for at least 10 years (81 FR 77555). We propose to revise § 414.1460(e) to apply to information submitted to us under § 414.1440 for QP determinations. We also proposed to add paragraph (3) to § 414.1460(e) stating that an APM Entity or eligible clinician who submits information to us under § 414.1445 or § 414.1440 must provide such information and supporting documentation to us upon our request. We sought comments on these proposals.
The following is a summary of the public comments received on these proposals and our responses:
In the CY 2017 Quality Payment Program final rule, we finalized that, to the extent permitted by federal law, we will maintain confidentiality of the information and data that APM Entities and eligible clinicians submit to support Other Payer Advanced APM determinations in order to avoid dissemination of potentially sensitive contractual information or trade secrets (81 FR 77479-77480).
We believe that it is similarly appropriate for us to maintain the confidentiality of information submitted to us for the purposes of QP determinations to the extent permitted by federal law. Therefore, we proposed that, to the extent permitted by federal law, we will maintain confidentiality of the information that APM Entities or eligible clinicians submit to us for purposes of QP determinations under the All-Payer Combination Option.
The following is a summary of the public comments we received on this proposal and our responses:
Additionally, we also note that records that a submitter marks as confidential will be protected from disclosure to the extent permitted by federal law. Specifically, Exemption 4 of the Freedom of Information Act (FOIA) authorizes our agency to withhold trade secrets and commercial or financial information obtained from a person and privileged or confidential. (45 CFR 5.31(d)). A person who submits records to the government may designate part or all of the information in such records that they may consider to be exempt from disclosure under Exemption 4 of
In the CY 2018 Quality Payment Program proposed rule, to illustrate how we would conduct QP determinations under the All-Payer Combination Option, we provided examples where an eligible clinician is in a Medicare ACO Model that we have determined to be an Advanced APM, a commercial ACO arrangement, and a Medicaid APM from January 1 through June 30, 2019 (82 FR 30205 through 30206). Because we are finalizing that one of the ways in which we will make QP determinations is at the individual eligible clinical level, this example illustrates how we will make individual eligible clinician level QP determinations.
In this example, we would use the information below to determine that eligible clinician's QP status for payment year 2021. We would calculate the Threshold Scores for the APM Entity group in the Advanced APM under the Medicare Option. For the payment amount method, as we show in Table 44 below, the APM Entity group would not attain QP status under the Medicare Option, which for payment year 2021 requires a QP payment amount Threshold Score of 50 percent. The APM Entity group would also fail to attain Partial QP status under the Medicare Option, which for payment year 2021 requires a Partial QP payment amount Threshold Score of 40 percent. For the patient count method, as we show in Table 45, the APM Entity group would not attain QP status under the Medicare Option, which for payment year 2021 requires a QP patient count Threshold Score of 35 percent. The APM Entity group would not attain Partial QP status under the Medicare Option, which for payment year 2021 requires a Partial QP patient count Threshold Score of 25 percent.
The APM Entity group did not attain QP or Partial QP status under either the payment amount or patient count method under the Medicare Option. However, because under both methods of calculation, the APM Entity group meets or exceeds the required Medicare threshold for the year under the All-Payer Combination Option of 25 percent and 20 percent, respectively, eligible clinicians within the APM Entity group would be eligible to obtain QP status through the All-Payer Combination Option. The eligible clinicians in the APM Entity group would have been
In this example above where we make the calculation at the individual eligible clinician level, the eligible clinician score exceeds the QP payment amount Threshold under the All-Payer Combination Option, which for payment year 2021 is 50 percent, but the eligible clinician only exceeds the Partial QP patient count Threshold under the All-Payer Combination Option, which for payment year 2021 is 25 percent. We would use the more advantageous score, so the eligible clinician would be a QP for payment year 2021.
Alternatively, if we were to use the APM Entity weighting methodology for calculation of a Threshold Score using the payment amount method as described in the proposed rule, we would apply the weighted methodology as follows:
The eligible clinician would obtain a Threshold Score of 58 percent. This would be slightly below the Threshold Score obtained from the individual eligible clinician payment count calculation, but it would still exceed the QP payment amount threshold of 50 percent under the All-Payer Combination Option. Based upon this Threshold Score, the eligible clinician would be a QP under the All-Payer Combination Option.
Because we are finalizing that we will in certain circumstances make QP determinations under the All-Payer Combination Option at the APM Entity level, we provide an example below of how we will make QP determinations at the APM Entity group level under the All-Payer Combination Option based on information shown in Tables 46 and 47. The APM Entity group score exceeds the QP payment amount Threshold under the All-Payer Combination Option, or 50 percent, but the APM Entity group only exceeds the Partial QP patent count Threshold under the All-Payer Combination Option, which for payment year 2021 is 25 percent. Again, we would use the more advantageous score, so the eligible clinician would be a QP for the payment year 2021.
In the 2017 Quality Payment Program final rule, we finalized under the Medicare Option that, 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 (81 FR 77449). To promote alignment with the Medicare Option and to simplify requirements when possible, we proposed that eligible clinicians who are Partial QPs for the year under the All-Payer Combination Option would make the election whether to report to MIPS and therefore be subject to MIPS reporting requirements and payment adjustments. We sought comment on this proposal. We received no comments in response to this proposal.
In summary, we are finalizing the following policies:
• We are finalizing at § 414.1305 that the QP Performance Period begins on January 1 and ends on August 31 of the calendar year that is 2 years prior to the payment year applies to the All-Payer Combination Option. We are not finalizing the terms All-Payer QP Performance Period and Medicare QP Performance Period.
• We are finalizing that we will make QP determinations based on eligible clinicians' participation in Advanced APMs and Other Payer Advanced APMs for 3 time periods: between January 1 through March 31, between January 1 through June 30, and between January 1 through August 31 of the QP Performance Period under the All-Payer Combination Option. We are finalizing that we will use data for the same time periods for Medicare payments or patients and that of other payers. We are codifying this policy at § 414.1440(d)(1).
• We are finalizing that we will notify eligible clinicians of their QP status under the All-Payer Combination Option as soon as practicable after the QP Determination Submission Deadline. We are codifying this policy at § 414.1440(g).
• We are finalizing that eligible clinicians may request that we make QP determinations at the individual eligible clinician level and that APM Entities may request that we make QP determinations at the APM Entity level. We are codifying this policy at § 414.1440(e).
• We are finalizing that we will use either individual eligible clinician level or APM Entity level payment amounts and patient counts for Medicare in the All-Payer Combination Option, depending on which level the request for QP determination is made. We are finalizing that when the eligible clinician's Medicare Threshold Score calculated at the individual eligible clinician level would be a lower percentage than the one that is calculated at the APM Entity level, and the eligible clinician requested that we make QP determinations at the individual eligible clinician level, we would apply the weighting methodology. We are codifying this policy at § 414.1440(d)(3).
• We are finalizing that we will determine whether a state operates a Medicaid APM or a Medicaid Medical Home Model that has been determined to be an Other Payer Advanced APM at a sub-state level. We are finalizing that we will use the county level to determine whether a state operates a Medicaid APM or a Medicaid Medical Home Model that meets the Other Payer Advanced APM at a sub-state level. We are codifying our policies pertaining to Title XIX excluded payments and patients at § 414.1440(a).
• We are finalizing that in a state where we determine there are one or more Medicaid APMs or Medicaid Medical Home Models that are Other Payer Advanced APMs in operation, but only in certain counties, or only for eligible clinicians in certain specialties, we would further evaluate whether those Medicaid APMs or Medicaid Medical Home Models were available to each eligible clinician for whom we make a QP determination under the All-Payer Combination Option. We will identify the county in which the eligible clinician practices by having the eligible clinician submit that information to identify the county where they saw the most patients during the relevant QP Performance Period when they request a QP determination. We are also finalizing that if the eligible clinician's practice is in a county, or in a specialty, in which there is no Medicaid APM or Medicaid Medical Home Model in operation, all of that eligible clinician's Medicaid payments and patients would be excluded from the numerator and denominator of the calculations under the payment amount or patient count method, respectively. We are also finalizing that we will identify Medicaid APMs or Medicaid Medical Home Models that are only open to certain specialties through questions requested of states in the Payer Initiated Process and of eligible clinicians in the Eligible Clinician Initiated Process. We would use the method generally used in the Quality Payment Program to identify an eligible clinician's specialty or specialties. We are codifying our policies pertaining to Title XIX excluded payments and patients at § 414.1440(a).
• For the payment amount method, we are finalizing that we would first make a calculation under the Medicare Option. If the minimum threshold score for the Medicare Option were met so that the eligible clinician could become a QP under the All-Payer Combination Option, and did not become a QP under the Medicare Option, we would make calculations under the All-Payer Combination Option. We are finalizing that under the All-Payer Combination Option the numerator would be the aggregate of all payments from all payers, except those excluded, that are made or attributable to the eligible clinician, under the terms of all Advanced APMs and Other Payer Advanced APMs. We are also finalizing that the denominator would be the aggregate of all payments from all payers, except those excluded, that are made or attributed to the eligible clinician. We are codifying our payment amount method policy at § 414.1440(b).
• For the patient count method under the All-Payer Combination Option, we are not finalizing our proposal and we are maintaining the policy that we finalized in the CY 2017 Quality Payment Program final rule. Specifically, for each APM Entity, we would count each unique patient one time in the numerator and one time in the denominator. However, the same patient could be counted separately in the numerator and denominator of two separate payers (for example, Medicare and Medicaid). We are codifying our patient count policy at § 414.1440(c).
• We are finalizing that we will require APM Entities or eligible clinicians to submit the necessary payment amount and patient count information for QP determinations under the All-Payer Combination Option aggregated for the two proposed snapshot timeframes: From January 1 through March 31, from January 1 through June 30, and from January 1 through August 31. We are finalizing that APM Entities may submit this information on behalf of any of the eligible clinicians in the APM Entity group at the individual eligible clinician level. If we receive information for some, but not all of the snapshots dates, we will use that information to make QP determinations under the All-Payer Combination Option. We are codifying this policy at § 414.1440(e).
• We are finalizing that if an APM Entity or eligible clinician submits sufficient information for either the payment amount or patient count method, but not for both, we will make a QP determination based on the one method for which we receive sufficient information. We are codifying this policy at §§ 414.1440(e)(3) and 414.1440(f)(1).
• We are finalizing that APM Entities or eligible clinicians must submit all of the required information about the Other Payer Advanced APMs in which they participate, including those for which there is a pending request for an Other Payer Advanced APM determination, as well as the payment amount and patient count information sufficient for us to make QP determinations by December 1 of the calendar year that is 2 years to prior to the payment year, which we refer to as the QP Determination Submission Deadline. We are codifying this policy at § 414.1440(e)(4).
• We are finalizing that an APM Entity or eligible clinician that submits information to request a QP determination under the All-Payer Combination Option must certify to the best of its knowledge that the information submitted is true, accurate and complete. In the case of information submitted by the APM Entity, we are finalizing that the certification needs to be made by an individual with the authority to bind the APM Entity. We are also finalizing that this certification must accompany the form that APM Entities or eligible clinicians submit to us when requesting that we make QP determinations under the All-Payer Combination Option. We are codifying this policy at § 414.1440(f)(2).
• We are finalizing that an APM Entity or eligible clinician that submits information to us under § 414.1440 for QP determinations must maintain such books, contracts, records, documents, and other evidence as necessary to enable the audit of QP determinations and the accuracy of APM Incentive Payments for a period of 6 years from the end of the QP Performance Period or from the date of completion of any audit, evaluation, or inspection, whichever is later.
• We are finalizing that APM Entities and eligible clinicians that submit information to us under § 414.1440 must provide such information and supporting documentation to us upon request. We are codifying this policy at § 414.1460(e)(3).
• We are finalizing that to the extent permitted by federal law, we will maintain confidentiality of the information that an APM Entity or eligible clinician submits to us for purposes of QP determinations under the All-Payer Combination Option.
• We are finalizing that eligible clinicians who are Partial QPs for the year under the All-Payer Combination Option would make the election whether to report to MIPS and then be subject to MIPS reporting requirements and payment adjustments.
Section 1868(c) of the Act established an innovative process for individuals and stakeholder entities (stakeholders) to propose physician-focused payment models (PFPMs) to the Physician-Focused Payment Model Technical Advisory Committee (PTAC). The PTAC, established under section 1868(c)(1)(A) of the Act, is a federal advisory committee comprised of 11 members that provides advice to the Secretary. A copy of the PTAC's charter, established on January 5, 2016, is available at
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.
In the CY 2017 Quality Payment Program final rule (81 FR 77555), we defined PFPM at § 414.1465 as an Alternative Payment Model (APM) in which: Medicare is a payer; 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 which targets the quality and costs of services that eligible clinicians participating in the APM provide, order, or can significantly influence. We stated that a PFPM could include other payers in addition to Medicare, but that other payer arrangements and Other Payer Advanced APMs are not PFPMs. Therefore, PFPM proposals would need to include Medicare as a payer.
In the CY 2018 Quality Payment Program proposed rule, we sought comment on whether to broaden the definition of PFPM to include payment arrangements that involve Medicaid or the Children's Health Insurance Program (CHIP) as a payer, even if Medicare is not included as a payer. A PFPM would then include Medicaid, CHIP, or Medicare (or some combination of these) as a payer. A PFPM might still include other payers in addition to Medicaid, CHIP, or Medicare; however, another payer arrangement or Other Payer Advanced APM that includes only private payers, including a Medicare Advantage (MA) plan, would not be a PFPM. As we indicated in the proposed rule, MA and other private plans paid to act as insurers on the Medicare program's behalf are considered to be private payers (82 FR 30208).
We sought comment on whether broadening the definition of PFPM would be inclusive of potential PFPMs that could focus on areas not generally applicable to the Medicare population, such as pediatric issues or maternal health, and whether changing the definition of PFPM may engage more stakeholders in designing PFPMs that include more populations beyond Medicare FFS beneficiaries. We sought comment on how the PFPM criteria could be applied to these payment arrangements. We sought comment on whether including more issues and populations fits within the PTAC's charge and whether stakeholders are interested in the opportunity to allow the PTAC to apply its expertise to a broader range of proposals for PFPMs (82 FR 30208).
The current definition of PFPM specifies that a PFPM is an APM. In the CY 2017 Quality Payment Program final rule (81 FR 77406), we noted that APM is defined under section 1833(z)(3)(C) of the Act as any of the following: (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; or (4) a demonstration required by federal law. If a payment arrangement is a PFPM it must also be an APM. Under our current regulation, a model that does not meet the definition of APM is not a PFPM. However, a payment arrangement with Medicaid or CHIP as the payer, but not Medicare, would not necessarily meet the definition of APM. Therefore, we sought comment on whether we should, in conjunction with potentially broadening the scope of PFPMs to include payment arrangements with
We also sought comment on whether states and stakeholders see value in having the definition of PFPM broadened to include payment arrangements with Medicaid or CHIP but not Medicare as a payer, and whether they see value in having proposals for PFPMs with Medicaid or CHIP but not Medicare as a payer go through the PTAC's review process (82 FR 30209).
The following is a summary of the public comments received on the areas where we sought comment related to the definition of PFPM and our responses:
In the CY 2018 Quality Payment Program proposed rule, we noted that section 1868(c) of the Act does not require PFPMs to meet the criteria to be an Advanced APM, and we did not define PFPMs solely as Advanced APMs. Stakeholders may therefore propose as PFPMs either Advanced APMs or Medical Home Models, or other APMs. We also noted that if we were to broaden the definition to include payment arrangements with Medicaid or CHIP but not Medicare as a payer, stakeholders could propose as PFPMs Medicaid APMs, Medicaid Medical Home Models, or other payer arrangements involving Medicaid or CHIP as a payer.
In the CY 2017 Quality Payment Program final rule (81 FR 77491-92), we described the roles of the Secretary, the PTAC, and CMS as they relate to PFPMs and the PTAC's review process. We provided additional information about the level of consideration the Secretary will give proposed PFPMs recommended by the PTAC and why we decline committing to specific timeframes for testing PFPMs. Although 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, we cannot guarantee that the development process would be shortened or estimate by how much it would be shortened. In the CY 2018 Quality Payment Program proposed rule, we reiterated these points and also included a discussion of how these principles might be applied were we to expand the definition of PFPM to include payment arrangements with Medicaid or CHIP, but not Medicare, as a payer (82 FR 30209).
The following is a summary of the public comments received on the areas where we sought comment related to the PTAC review process of PFPM proposals with Medicaid or CHIP as a payer and our responses:
In the CY 2017 Quality Payment Program final rule (81 FR 77555), we finalized the Secretary's criteria for PFPMs as required by section 1868(c)(2)(A)(i) of the Act (PFPM criteria). The PFPM criteria are for the PTAC's use in discharging its duties under section 1868(c)(2)(C) of the Act to
In the CY 2018 Quality Payment Program proposed rule, we sought comment on the PFPM criteria, including, but not limited to, whether the criteria are appropriate for evaluating PFPM proposals and are clearly articulated. In addition, we sought comment on stakeholders' needs in developing PFPM proposals that meet the Secretary's criteria. In particular, we want to know whether stakeholders believe there is sufficient guidance available on what constitutes a PFPM, the relationship between PFPMs, APMs, and Advanced APMs; and on how to access data, or how to gather supporting evidence for a PFPM proposal (82 FR 30209).
The following is a summary of the public comments received on the areas where we sought comment related to the PFPM criteria and our responses:
In this final rule with comment period, we are not proposing or making changes to the existing definition of PFPM or the PFPM criteria. We will consider the comments received on the adequacy of guidance available on PFPM criteria and, within the scope of CMS authority, follow the guidance of the Secretary in the Secretary's responses to the PTAC comments and recommendations.
This interim final rule with comment period is being issued in conjunction with the final rule with comment period and its provisions discussed in sections II.C.6.f.(7) and II.C.7.b.(3)(c) pertaining to the policies that apply to MIPS eligible clinicians who are subject to extreme and uncontrollable circumstances. As we discussed in section II.C.6.f.(7) of the final rule with comment period, we established a policy to assign a weight of zero percent to the advancing care information performance category in the final score for MIPS eligible clinicians who demonstrate a significant hardship through an application process, and we are relying on section 1848(o)(2)(D) of the Act as the authority for that policy. We recognized that one type of significant hardship a clinician might experience would be extreme and uncontrollable circumstances, such as a natural disaster in which an EHR or practice building are destroyed (81 FR 77241). This policy for the advancing care information performance category applies beginning with the transition year of MIPS (2017 performance period/2019 MIPS payment year) (81 FR 77240 through 77243). As we discussed in section II.C.6.f.(7) of the final rule with comment period, to be considered for reweighting of the advancing care information performance category in the final score for the transition year based on extreme and uncontrollable circumstances, a MIPS eligible clinician must submit an application by December 31, 2017. A MIPS eligible clinician who is eligible for reweighting but chooses to report (as an individual, group, or virtual group) for the advancing care information performance category will be scored on the 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.
In addition, as we discussed in section II.C.7.b.(3)(c) of the final rule with comment period, we are establishing a similar policy for the quality, cost, and improvement activities performance categories beginning with the second year of MIPS
For many of our quality reporting and value-based purchasing programs for hospitals and other types of facilities, we have adopted extraordinary circumstances exceptions (ECE) policies. In the FY 2018 IPPS/LTCH PPS final rule (82 FR 38410) and CY 2018 OPPS/ASC proposed rule (82 FR 33683), we worked to align common processes for our ECE policies across many of our quality programs including the Hospital IQR Program, Hospital OQR Program, IPFQR Program, ASCQR Program, and PCHQR Program, as well as the Hospital VBP Program, HAC Reduction Program, and the Hospital Readmissions Reduction Program. Using the Hospital IQR Program as an example, generally, CMS may grant an exception with respect to quality data reporting requirements in the event of extraordinary circumstances beyond the control of the hospital (42 CFR 412.140(c)(2)). Specific requirements for submission of a request for an exception are available on
The events of Hurricanes Harvey, Irma, and Maria impacted large regions of the United States in August and September of 2017. These events occurred over a period of several days and led to widespread destruction of infrastructure within impacted regions which impacted residents' ability to carry on normal functions in the months following the events. Hurricane Harvey made landfall in Texas as a category 4 hurricane on August 25, 2017, and produced rainfall totals of 45 to 50 inches (depending on county) over a 5-day period. The rainfall caused catastrophic drainage issues and made rivers rise greatly. After moving offshore, Harvey made a third landfall just west of Cameron, Louisiana on the morning of August 30th and brought more heavy rainfall to the Northern Gulf States.
Irma:
Harvey:
Maria:
Due to Hurricanes Harvey, Irma, and Maria, which occurred during the 2017 MIPS performance period, we believe that changes to our policies for extreme and uncontrollable circumstances are
Given the broad impact of these three hurricanes, in this interim final rule with comment period, we are establishing a policy for the 2017 MIPS performance period under which we would apply the extreme and uncontrollable circumstance policies for the MIPS performance categories as described in sections II.C.6.f.(7) and II.C.7.b.(3)(c) of the final rule with comment period without requiring a MIPS eligible clinician to submit an application when we determine a triggering event, as described in section III.B.1.a. of this interim final rule with comment period, has occurred and the clinician is in an affected area. We refer to this policy as the “automatic extreme and uncontrollable circumstance policy.” We believe the automatic extreme and uncontrollable circumstance policy will reduce burden for clinicians who have been affected by these catastrophes and will also align with existing Medicare policies in other programs such as the Hospital IQR Program. Further, we believe it is necessary to adopt the automatic extreme and uncontrollable circumstance policy in an interim final rule with comment period due to the urgency of providing relief for MIPS eligible clinicians impacted by the recent hurricane events during the 2017 MIPS performance period. In particular, we are concerned about individual MIPS eligible clinicians receiving a negative MIPS payment adjustment for failure to submit information on the MIPS measures and activities when events outside of their control, such as the hurricanes, would likely constitute a significant hardship for clinicians and affect whether sufficient measures and activities are applicable and available to them. As discussed in section III.B.1. of this interim final rule with comment period, although this policy includes individual MIPS eligible clinicians who practice in impacted areas and are part of a group practice, the policy does not apply to groups for the transition year, although we may address its application to groups in future rulemaking. We believe there is less urgency to establish a policy for groups given the low performance threshold (three points) for the transition year, and the fact that groups are only scored as groups if they submit information to MIPS as a group. For these reasons, we believe virtually all groups (including those in the impacted areas) would not receive final scores below the performance threshold, and thus the MIPS eligible clinicians in those groups would not be subject to a negative payment adjustment.
We invite public comment on our automatic extreme and uncontrollable circumstance policy for individual MIPS eligible clinicians for the 2017 MIPS performance period.
Under the automatic extreme and uncontrollable circumstance policy, we will have discretion not to require MIPS eligible clinicians to submit an application for reweighting the performance categories in cases where an extreme and uncontrollable circumstance, such as an act of nature (for example, hurricane), affects an entire region or locale. Generally, we anticipate the types of events that could trigger this policy would be events designated a Federal Emergency Management Agency (FEMA) major disasters or a public health emergency declared by the Secretary, although we will review each situation on a case-by-case basis. We also generally intend to align the automatic extreme and uncontrollable circumstance policy with the ECE policies for other Medicare programs such that events that trigger ECE policies would also trigger the automatic extreme and uncontrollable circumstance policy.
We believe that Hurricanes Harvey, Irma, and Maria are such triggering events and have provided details about the affected regions in section III.B.1.d. of this interim final rule with comment period. Should additional extreme and uncontrollable circumstances arise for the 2017 MIPS performance period that trigger the automatic extreme and uncontrollable circumstance policy, then we would communicate that information through routine communication channels, including but not limited to issuing memos, emails, and notices on the QPP Web site,
We invite comments on applying the automatic extreme and uncontrollable circumstance policy based on triggering events that affect an entire region or locale, on a case-by-case basis.
If we determine that an event should trigger the automatic extreme and uncontrollable circumstance policy, then we will assume that MIPS eligible clinicians in the affected areas do not have sufficient measures and activities available and applicable to them for the quality and improvement activities performance categories. Similarly, we will assume that MIPS eligible clinicians in the affected areas are experiencing a significant hardship as a result of the triggering event and would qualify for a significant hardship exception for the advancing care information performance category. We will not require MIPS eligible clinicians in the affected areas to submit an application to CMS (as described in sections II.C.6.f.(7) and II.C.7.b.(3)(c) of the final rule with comment period) requesting that the performance categories be reweighted. We believe requiring an application could be overly burdensome to these MIPS eligible clinicians who have been affected by extreme events, such as hurricanes and other natural disasters, and who may have been displaced from their homes or practice locations as a result of such events. Because the cost performance category has a zero percent weight for the 2017 MIPS performance period, we are not including the cost performance category in the automatic extreme and uncontrollable circumstances policy for the transition year.
For MIPS eligible clinicians who practice in the affected areas, if they do not submit data for the quality, advancing care information, and/or improvement activities performance categories, then each category for which they do not submit data will not be scored and will be assigned a weight of zero percent in the final score. Because we believe the final score should be a composite score, we adopted a policy in section II.C.7.b.(2) of the final rule with comment period that a MIPS eligible clinician with fewer than two performance category scores will receive a final score equal to the performance threshold, and we would apply this policy for the transition year as well as 2018 and subsequent years.
It is possible that some MIPS eligible clinicians in the affected areas may not be significantly impacted by the extreme and uncontrollable circumstance. These clinicians might not experience a
For the 2017 MIPS performance period, it is possible we may receive data from MIPS eligible clinicians in affected areas that does not represent the entire performance period. In those cases, we will score the submitted data, even if does not represent the entire performance period. For example, for the claims submission mechanism for the quality performance category, measures are submitted by adding quality data codes to a claim. It is possible that a MIPS eligible clinician in an affected area could have submitted some data prior to the triggering event for the automatic extreme and uncontrollable circumstance policy. However, due to the policy we adopted in section II.C.7.b.(2) of the final rule with comment period that a MIPS eligible clinician with fewer than two performance category scores will receive a final score equal to the performance threshold, the clinician would also have to submit data for the improvement activities or the advancing care information performance categories in order to receive a final score higher than the performance threshold.
For measures which we derive from administrative claims data, such as the all-cause hospital readmission measure and the cost measures, clinicians do not submit data other than claims. However, for the 2017 MIPS performance period/2019 MIPS payment period, cost measures are not used to determine the MIPS final score and the only administrative claims quality measure used to determine the MIPS final score is the readmission measure, which is only applied to groups (which are excluded from our automatic extreme and uncontrollable circumstance policy); therefore, administrative claims measures are not included in our automatic extreme and uncontrollable circumstance policy for this interim final rule with comment period.
We invite public comments on these policies related to scoring the performance categories.
We will determine if an individual MIPS eligible clinician is in an impacted area based on the practice location address listed in the Provider Enrollment, Chain and Ownership System (PECOS). As discussed above, the individual MIPS eligible clinician will receive a final score equal to the performance threshold for the 2017 MIPS performance period if they do not submit any data or submit data on only one performance category by the applicable submission deadline for the 2017 performance period. If the individual MIPS eligible clinician submits data on 2 or more performance categories, then the clinician will be scored on their data submissions under the policies that apply to all other MIPS eligible clinicians who are not in affected areas.
As discussed above, groups are not included in the automatic extreme and uncontrollable circumstance policy in this interim final rule with comment period. We would consider expanding this policy to include groups in future years, but we believe there are some policy questions that need to be addressed through rulemaking first. For example:
• How should we determine whether a group, which may have multiple practice sites, should qualify for the automatic extreme and uncontrollable circumstance policy?
• Should it be based on whether a certain percentage of the clinicians in the group are located in an affected area?
As we explained above, we believe it is less urgent to establish a policy for groups for the transition year. If an individual MIPS eligible clinician's practice location address as listed in PECOS is in an affected area, and the clinician is part of a group practice that reports as a group for MIPS for the 2017 performance period and receives a final score below the performance threshold (as explained above, we believe this will be unlikely given the low performance threshold of 3 points), that clinician still will receive a final score equal to the performance threshold under our policy. We seek comment on our policy to determine which MIPS eligible clinicians are in affected areas based on practice location addresses listed in PECOS, and how we should apply the automatic extreme and uncontrollable circumstance policies for groups and virtual groups in future years.
We believe the recent Hurricanes Harvey, Irma, and Maria are triggering events for the automatic extreme and uncontrollable circumstance policy we are adopting in this interim final rule with comment period. The regions impacted by these events are defined as a major disaster county, municipal (municipio in Spanish), or county-equivalent by the Federal Emergency Management Agency (FEMA) and are:
• All 67 counties in Florida.
• All 159 counties in Georgia.
• The following parishes of Louisiana: Acadia; Allen; Assumption; Beauregard; Calcasieu; Cameron; De Soto; Iberia; Jefferson Davis; Lafayette; Lafourche; Natchitoches; Plaquemines; Rapides; Red River; Sabine; St. Charles; St. Mary; Vermilion; and Vernon.
• All 78 municipios in Puerto Rico.
• The following counties of South Carolina: Allendale; Anderson; Bamberg; Barnwell; Beaufort; Berkeley; Charleston; Colleton; Dorchester; Edgefield; Georgetown; Hampton; Jasper; McCormick; Oconee; and Pickens.
• The following counties in Texas: Aransas; Austin; Bastrop; Bee; Bexar; Brazoria; Burleson; Caldwell; Calhoun; Chambers; Colorado; Comal; Dallas; Dewitt; Fayette; Fort Bend; Galveston; Goliad; Gonzales; Grimes; Guadalupe; Hardin; Harris; Jackson; Jasper; Jefferson; Jim Wells; Karnes; Kleberg; Lavaca; Lee; Liberty; Madison; Matagorda; Milam; Montgomery; Newton; Nueces; Orange; Polk; Refugio; Sabine; San Augustine; San Jacinto; San Patricio; Tarrant; Travis; Tyler; Victoria; Walker; Waller; Washington; and Wharton.
• All of the U.S. Virgin Islands.
These lists may continue to be updated. The most current list of impacted areas can be found at
As discussed above, we adopted a policy in section II.C.7.b.(2) of the final rule with comment period that a MIPS eligible clinician with fewer than two performance category scores will receive
In the CY 2017 Quality Payment Program final rule (81 FR 77325 through 77329), we adopted a policy for redistributing the weights of the performance categories in the final score for the 2017 performance period/2019 MIPS payment year. We stated that we envisioned that all MIPS eligible clinicians would have sufficient improvement activities applicable and available to them (81 FR 77323), and our policy did not include a scenario where a MIPS eligible clinician would not receive an improvement activities performance category score for 2017. With the addition of the automatic extreme and uncontrollable circumstance policy in this interim final rule with comment period, it is possible for a MIPS eligible clinician not to receive a score for the improvement activities performance category and for the category to be reweighted to zero percent in the final score; therefore, we need to modify our existing policy for redistributing the performance category weights for 2017 to account for this situation.
In the CY 2018 Quality Payment Program proposed rule (82 FR 30144-30146), we proposed a policy for redistributing the performance category weights for the 2018 performance period/2020 MIPS payment year based on our proposal to weight the cost performance category at zero percent of the final score. Although we are not finalizing these proposals, as explained in section II.C.7.b.(2) of the final rule with comment period, we will adopt this redistribution policy (reflected in Table 48) for the 2017 performance period/2019 MIPS payment year. This policy is the same as our existing policy for the transition year, but also accounts for the scenario where a MIPS eligible clinician has a score for the quality and advancing care information performance categories, but not an improvement activities performance category score; in this case we would redistribute the weight of the improvement activities performance category to the quality performance category.
In the CY 2017 Quality Payment Program final rule (81 FR 77246 through 77269, 77543), we finalized the APM scoring standard, which is designed to reduce reporting burden for participants in certain APMs by minimizing the need for them to make duplicative data submissions for both MIPS and their respective APMs.
We are not modifying the APM scoring standard policies that apply in 2017 for MIPS eligible clinicians who have been affected by extreme and uncontrollable circumstances. The cost performance category has been waived under the APM scoring standard (81 FR 77258, 77262, and 77266). We will continue to apply the quality performance category scoring methodology described in section II.C.7.a.(2) of the final rule with comment period. The improvement activities performance category will continue to be automatically scored (81 FR 77266). The advancing care information performance category will be scored according to the policies described in section II.C.6.g.(3)(d) of the final rule with comment period for APM Entities scored under the APM scoring standard, which would include MIPS eligible clinicians in affected areas who qualify for a zero percent weighting of the advancing care information performance category under the automatic extreme and uncontrollable circumstance policy adopted in this interim final rule with comment period.
Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), the agency is required to publish a notice of the proposed rule in the
We find that there is good cause to waive the notice and comment requirements under sections 553(b)(B) of the APA and section 1871(b)(2)(C) due to the impact of Hurricanes Harvey, Irma, and Maria as described in section III.A.3. of this interim final rule with comment period. Based on the size and scale of the destruction and displacement caused by these natural disasters in the regions identified in section III.A.3. of this interim final rule with comment period, we believe it is likely that some MIPS eligible clinicians have been significantly adversely affected by these events. It is possible that some MIPS eligible clinicians may have had to temporarily close their practice locations, or may lack access to their EHR technology or other data they would need to submit for MIPS for the 2017 performance period. We believe it is in the public interest to adopt these interim final policies to provide relief to impacted individual MIPS eligible
We find that it would be impracticable and contrary to the public interest to undergo notice and comment procedures before finalizing, on an interim basis with an opportunity for public comment, the policies described herein for individual MIPS eligible clinicians who have been affected by extreme and uncontrollable events that impact an entire region or locale. Therefore, we find good cause to waive the notice of proposed rulemaking as provided under section 1871(b)(2)(C) of the Act and section 553(b)(B) of the APA and to issue this interim final rule with an opportunity for public comment. We are providing a 60-day public comment period as specified in the
Under the Paperwork Reduction Act of 1995 (PRA), we are required to publish a 60-day notice in the
• The need for the information collection and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our burden estimates.
• The quality, utility, and clarity of the information to be collected.
• Our effort to minimize the information collection burden on the affected public, including the use of automated collection techniques.
We solicited public comment in the CY 2018 Quality Payment Program proposed rule on each of the required issues under section 3506(c)(2)(A) of the PRA for the following information collection requirements (ICRs) (82 FR 30213 through 30230).
In the CY 2017 Quality Payment Program final rule, we estimated a reduction of burden costs of $7.4 million relative to the legacy programs (PQRS and EHR Incentive Program for Eligible Professionals) it replaced (81 FR 77513). The streamlining and simplification of data submission structures in the transition year resulted in a reduction in burden relative to the approved information collections for the legacy programs. We estimate that the policies finalized in this final rule with comment period would result in further reduction of approximately 171,264 burden hours and a further reduction in burden cost of approximately $13.9 million relative to a $708 million baseline of continuing the policies in the CY 2017 Quality Payment Program final rule.
For our CY 2018 Quality Payment Program final rule with comment period burden estimates, we used several data sources. We used the 2017 MIPS eligibility file and the initial QP determination file for the 2017 Quality Payment Program performance year to account for which clinicians or groups would be excluded from or ineligible for MIPS, and which clinicians and groups would be exempt from the advancing care information performance category. We also used 2016 PQRS data and 2015 and 2016 Medicare and Medicaid EHR Incentive Program data to estimate the number of participants (or respondents) for the performance categories.
The Quality Payment Program Year 2 reduction in burden based on this final rule with comment period reflects our decision to finalize several proposed policies from the CY 2018 Quality Payment Program proposed rule, including our proposal for significant hardship or other type of exception, including a new significant hardship exception for small practices for the advancing care information performance category; our proposal to use a shorter version of the CAHPS for MIPS survey; and our proposal to allow MIPS eligible clinicians to form virtual groups which would create efficiencies in data submission. We chose to finalize the following proposals beginning with the CY 2019 performance period rather than the CY 2018 performance period as proposed: Implementing facility based measurement (82 FR 30125) and allowing MIPS eligible clinicians (82 FR 30035 through 30035) to submit data via multiple submission mechanisms for a single performance category and these changes are reflected in our burden estimates.
In addition to the decline in burden due to the policies proposed in this rule, we anticipate further reduction in burden because of policies set forth in the CY 2017 Quality Payment Program final rule, including greater clinician familiarity with the measures and data submission methods set in their second year of participation, operational improvements streamlining registration and data submission.
We also see a decline in burden compared to the CY 2017 Quality Payment Program final rule based on the initial QP determination file, which we used to identify 100,649 QPs that would have otherwise reported as part of a group or as an individual clinician that will be excluded from MIPS in 2017 based on policies established in the CY 2017 Quality Payment Program final rule. Our estimates assume clinicians who participated in the 2016 PQRS and who are not QPs in Advanced APMs in the 2017 Quality Payment Program performance period will continue to submit quality data as either MIPS eligible clinicians or voluntary reporters in the 2018 Quality Payment Program performance period. Our participation estimates are reflected in Table 54 for the quality performance category, Table 65 for the advancing information performance category, and Table 67 for the improvement activities performance category. We estimate that 35 percent of the estimated 825,673 clinicians (288,986 clinicians) that are not subject to a MIPS payment adjustment in CY 2018, will report voluntarily and are included in our CY 2018 burden estimates because they reported previously under PQRS. We expect them to continue to submit because (a) the collection and submission of quality data has been integrated into their clinician practice; and (b) the clinician types that were ineligible from MIPS in the Quality Payment Program Years 1 and 2 may potentially become eligible in the future.
We also assume that previous PQRS participants who are not QPs will also submit under the improvement activities performance category, and will submit under the advancing care information performance category unless they receive a significant hardship or other type of exception, including a new significant hardship exception for small practices or are automatically assigned a weighting of zero percent for the advancing care information performance category.
Due to data limitations, these burden estimates may overstate the total burden for data submission under the quality, advancing care information, and improvement activities performance categories. Because of the total expected growth in Advanced APM participation, the estimated number of QPs excluded from our burden estimates based on data from the 2017 Quality Payment Program performance period (100,649) is lower than the summary level projection for the 2018 Quality Payment Program performance period based on the total expected growth in APM participation
This total expected growth in Advanced APM participation is due in part to the addition of new participants in the CPC+ and Next Generation ACO models for 2018, and the start of the Medicare ACO Track 1+ Model which is projected to have a large number of participants, with a large majority reaching QP status. Hence, our model may overestimate the numbers of clinicians and groups that will report data under the quality, advancing care information, and improvement activities performance categories.
Our burden estimates assume that 35 percent of the 825,673 clinicians who do not exceed the low-volume threshold or are not eligible clinician types (288,986) will voluntarily submit quality data under MIPS because they submitted quality data under the PQRS. Hence, the finalized changes in low-volume threshold will increase our estimate of the proportion of clinicians who will submit data voluntarily, but will not affect our overall burden estimate. As discussed in section II.C.2.c. of this final rule with comment period, we are finalizing at § 414.1305 that clinicians or groups who have Medicare Part B allowed charges less than or equal to $90,000 or provide care for 200 or fewer Part B-enrolled Medicare beneficiaries are excluded from MIPS. The CY 2017 Quality Payment Program final rule established a low-volume threshold of less than or equal to $30,000 in allowed Medicare Part B charges or less than or equal to 100 Medicare patients (81 FR 77069).
The revised MIPS requirements and burden estimates for all ICRs listed below (except for CAHPS for MIPS and virtual groups election) were submitted as a request for revision of OMB control number 0938-1314. The CAHPS for MIPS ICR was submitted as a request for revision of OMB control number 0938-1222. Due to the statutory requirement for the virtual group election process to take place prior to the start of the 2018 MIPS performance period, the information collection request for the virtual group election process was submitted for OMB review and approval separately from this rulemaking process and is assigned to OMB control number 0938-1343. Please note that the 60-day
The following is a summary of general public comments received regarding our request for information on our information collections and our responses. We received several general comments regarding the burden of data collection.
Further, absent specific information from the commenter as to why the commenter believes our burden estimates are low, we cannot specifically address commenter's burden concerns because no particular reference was made to any of the burden hours or costs provided across our burden estimate tables. Generally, we believe that our burden estimates provide a reasonable and appropriate assessment of burden on clinicians in the Quality Payment Program. Our estimates are grounded in reliable data
We are also finalizing that we will compare MIPS eligible clinicians' final scores against a MIPS performance threshold of 15 points, which can be achieved via multiple pathways and continues the gradual transition into MIPS. While we acknowledge commenters' concerns that these more rigorous requirements for Quality Payment Program Year 2 may lead to increased data submission burden, we clarify that our burden estimates in the CY 2017 Quality Payment Program final rule accounted for MIPS eligible clinicians choosing the full year participation option in MIPS with complete data submission (as opposed to reporting only the minimum 90 days of data required by the rule) for the 2017 performance period and, therefore, we did not adjust these estimates for this final rule with comment period. Further, we anticipate that the burden will be reduced as eligible clinicians become more familiar with the requirements of the Quality Payment Program.
Because eligible clinicians will need to become familiar with the new requirements of this final rule with comment period, we will use our extensive outreach efforts to improve clinician understanding to the greatest extent possible. Additionally, in keeping with the objectives to provide education about the Quality Payment Program and maximize participation, and as authorized by section 1848(q)(11) of the Act, during a period of 5 years, $100 million in funding was provided for technical assistance to be available to provide guidance and assistance to MIPS eligible clinicians in small practices through contracts with regional health collaboratives, and others. Finally, the Regulatory Impact Analysis includes a general discussion of the potential costs to clinicians of meeting MIPS requirements, including implementation costs and the costs of reviewing this final rule with comment period. Consistent with the PRA, this section of the final rule with comment period only estimates the costs for submitting data (including reviewing measure specifications) and associated record keeping.
After consideration of the public comments, we are not making any changes to our burden estimate methodology, but we are making changes to the burden to reflect the decisions to finalize the following proposals beginning with the CY 2019 performance period rather than the CY 2018 performance period as proposed: Implementing facility based measurement (82 FR 30125) and allowing MIPS eligible clinicians (82 FR 30035 through 30035) to submit data via multiple submission mechanisms for a single performance category.
We note that we are also adopting policies in an interim final rule with comment period that address extreme and uncontrollable circumstances MIPS eligible clinicians may face as a result of widespread catastrophic events affecting a region or locale in CY 2017, such as Hurricanes Irma, Harvey and Maria. We refer readers to section IV.P of this document for the collection of information requirements related to the interim final rule with comment period.
To derive wage estimates, we used data from the U.S. Bureau of Labor Statistics' (BLS) May 2016 National Occupational Employment and Wage Estimates for all salary estimates (
As indicated, we are adjusting our employee hourly wage estimates by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer to employer, and because methods of estimating these costs vary widely from study to study. Nonetheless, there is no practical alternative, and we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method. We have selected
In addition, to calculate time costs for beneficiaries who elect to complete the CAHPS for MIPS survey, we have used wage estimates for Civilian, All Occupations, using the same BLS data discussed in the proposed rule (82 FR 30010). 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 completing the survey. To calculate time costs for virtual groups to prepare their written formal agreements, we have used wage estimates for Legal Support Workers, All Others.
Because of the wide range of information collection requirements under MIPS, Table 50 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 50, MIPS eligible clinicians that are not in MIPS APMs and other clinicians voluntarily submitting data will submit data either as individuals, groups, or virtual groups, as applicable, to the quality, advancing care information, and improvement activities performance categories. Because the cost performance category relies on administrative claims data, MIPS eligible clinicians are not requested to provide any additional information and therefore claims data is not represented in Table 50.
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 2018 MIPS performance period, the quality data submitted by Shared Savings Program ACOs, Next Generation ACOs, and APM Entities in Other MIPS APMs on behalf of their participant MIPS eligible clinicians will fulfill any 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. In the CY 2017 Quality Payment Program final rule, we describe how we determine MIPS APM scores (81 FR 77185). We compare the requirements of the specific MIPS APM with the list of activities in the Improvement Activities Inventory and score those activities in the same manner that they are otherwise scored for MIPS eligible clinicians. If, by our assessment, the MIPS APM does not receive the maximum improvement activities performance category score then the APM Entity can submit additional improvement activities. We assume that MIPS APMs available for the CY 2018 MIPS performance period will receive the maximum improvement activities performance category score, and therefore, will not require the APM Entity to submit additional improvement activities. Advanced APM participants who are determined to be Partial QPs may incur additional burden if they elect to participate in MIPS, which is discussed in more detail in section II.D.5. of this final rule with comment period.
The policies finalized
• Self-nomination of new and returning QCDRs and registries (0938-1314).
• CAHPS for MIPS survey completion by beneficiaries (0938-1222).
• Approval process for new and returning CAHPS for MIPS survey vendors.
• Call for new improvement activities (see section II.C.6.e.(7) of this final rule with comment period).
• Call for new advancing care information measures.
• Other Payer Advanced APM determinations: Payer Initiated Process.
• Opt out of performance data display on Physician Compare for voluntary reporters under MIPS.
We did not receive comments specific to our framework for understanding the burden of MIPS data submission.
As described in section II.C.4.b. of this final rule with comment period, virtual groups are defined by a combination of 2 or more TINs and must report as a virtual group on measures in all quality, improvement activities, and advancing care information performance categories as virtual groups. Virtual groups may submit data through any of the mechanisms available to groups. We refer to section II.C.4. of this final rule with comment period on additional requirements for virtual groups.
In section II.C.4.e. of this final rule with comment period, we are establishing an optional 2-stage process for enrollment. In stage 1, MIPS eligible clinicians have the option to request a determination of their eligibility to form a virtual group before they form a group and begin the stage 2 submission of an election to participate in a virtual group. For clinicians or groups that do not choose to participate in stage 1 of the election process, we will make an eligibility determination during stage 2 of the election process. We refer readers to section II.C.4.e. of this final rule with comment period for a discussion of the finalized virtual group election process.
As established in section II.C.4.e. of this final rule with comment period, the submission of a virtual group election must include, at a minimum, detailed information pertaining to each TIN and NPI associated with the virtual group and detailed information for the virtual group representative, as well as confirmation of a written formal agreement between members of the virtual group at the TIN level.
We assume that virtual group participation will be relatively low in the first year because we have heard from stakeholders that they need at least 3 to 6 months to form groups and establish agreements before signing up. We are not able to give them that much time in the first year, rather closer to 60 days. Because of this, we expect the number of virtual groups will be very small in the first year of virtual group implementation. Our assumptions for participation in a virtual group are shown in Table 51. We assume that only those eligible clinicians that reported historically will participate in virtual groups in the first year because of the limited lead time to create processes. Also, while virtual groups may use the same submission mechanisms as groups, we are estimating based on stakeholder feedback that the 16 virtual groups reflected in Table 51 will report by registry. Table 51 also shows that we estimate that approximately 765 MIPS eligible clinicians will decide to join 16 virtual groups for the 2018 MIPS performance period. We assumed each of the 16 virtual groups would consist of approximately 5 TINs (765 MIPS eligible clinicians ÷ 48 eligible clinicians per virtual group) or 80 TINs total that will participate in virtual groups (16 virtual groups × 5 MIPS eligible clinicians per TIN).
We assume that the virtual election process will require 10 hours per virtual group, similar to the burden of the QCDR or registry self-nomination process finalized in § 414.1400. We assume that 8 hours of the 10 burden hours per virtual group will be computer systems analyst's time or the equivalent with an average labor cost of $88.10/hour, and an estimated cost of $704.80 per virtual group ($88.10/hour × 8 hours). We also assume that 2 hours of the 10 burden hours per virtual group will be legal support services professionals assisting in formulating the written virtual agreement with an average labor cost of $63.62/hour, with a cost of $127.24 per virtual group ($63.62/hour × 2 hours). Therefore, the total burden cost per virtual group associated with the election process is $832.04 ($704.80 + $127.24). We also assume that 16 new virtual groups will go through the election process leading to a total burden of $13,313 ($832.04 × 16 virtual groups). We estimate that the total annual burden hours will be 160 (16 virtual groups × 10 hours).
While the formation of virtual groups will result in a burden for virtual group registration, we also estimate that the formation of virtual groups will result in a decline in burden from other forms of data submission. Because we assume burden is the same for each organization (group, virtual group, or eligible clinician) submitting quality, improvement activities or advancing care information performance category data, virtual groups will reduce burden by reducing the time needed to prepare data for submission, review measure specifications, register or elect to submit data via a mechanism such as QCDR, registry, CMS Web Interface, or EHR. This reduction in burden is described in
As stated earlier, the information collection request for the virtual group election process was reviewed and approved by OMB (0938-1343) separately from this rulemaking process. We announced the opportunity for the public to comment on the virtual group election process via a 60-day
The following is a summary of the public comments received regarding our request for on the 2018 Quality Payment Program proposed rule regarding our estimated burden for the virtual group election process.
After considerations of public comments, we are making no changes to our virtual group election process burden estimates as a result of public comments received. The burden estimates have not been updated from the CY 2018 Quality Payment Program proposed rule (82 FR 2013).
Because we are not finalizing the policy to allow facility-based measurement until the 2019 MIPS performance period, we have revised our burden estimates to include back into our quality performance category data submission burden estimates 17,943 eligible clinicians who practice primarily in the hospital that did not submit under the 2017 MIPS performance period that would have elected facility-based measurement as individuals in the 2018 MIPS performance period. We also revised our burden estimates to include back into our quality performance category data submission burden estimates 264 groups who practice primarily in the hospital that previously submitted as groups under the 2017 MIPS performance period that we projected would have elected facility-based measurement in the 2018 MIPS performance period. We also removed the burden estimate of 1 hour of a billing clerk's time at $36.12/hr. for each of these individuals or groups that would have otherwise elected facility-based measurement or a total annual burden cost of $657,637 (18,207 × $36.12) for the election process to participate in facility-based measurement.
Under MIPS, quality, advancing care information, and improvement activities performance categories' data may be submitted via relevant third-party intermediaries, such as qualified registries, QCDRs and health IT vendors. The CAHPS for MIPS survey data, which counts as one quality performance category measure, can be submitted via CMS-approved survey vendors. The burdens associated with qualified registry and QCDR self-nomination and the CAHPS for MIPS survey vendor applications are discussed below.
For the 2017 MIPS performance period, 120 qualified registries and 113 QCDRs were qualified to report quality measures data for purposes of the PQRS, an increase from 114 qualified registries and 69 QCDRs in CY 2016.
In sections II.C.10.b.(2)(b) and II.C.10.d.(2)(b) of this final rule with comment period, we finalized our proposals with clarification that previously approved QCDRs and qualified registries in good standing (that are not on probation or disqualified) that wish to self nominate using the simplified process can attest, in whole or in part, that their previously approved form is still accurate and applicable . We clarified our proposals by elaborating on what would be required for previously approved entities in good standing that wish to self-nominate and have minimal or substantive changes. As we discussed in II.C.10.d.(2)(b)(i) and (ii) of this final rule with comment period, existing
We estimate that the self-nomination process for 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. The self-nomination form is submitted electronically using a web-based tool. We proposed to eliminate the option of submitting the self-nomination form via email that was available in the transition year.
In addition to completing a self-nomination statement, qualified registries and QCDRs will need to perform various other functions, such as meeting with CMS officials when additional information is needed. In addition, QCDRs calculate their measure results. QCDRs must possess benchmarking capability (for QCDR measures) that compares the quality of care a MIPS eligible clinician provides with other MIPS eligible clinicians performing the same quality measures. For QCDR measures the QCDR must provide to us, if available, data from years prior (for example, 2016 data for the 2018 MIPS performance period) before the start of the performance period. In addition, the QCDR must provide to us, if available, the entire distribution of the measure's performance broken down by deciles. As an alternative to supplying this information to us, the QCDR may post this information on their Web site prior to the start of the performance period, to the extent permitted by applicable privacy laws. 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.
As shown in Table 52, 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 $88.10/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 2,330 ((113 QCDRs + 120 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 $881.00 ($88.10 per hour × 10 hours per qualified registry). We also estimate that 233 qualified registries or QCDRs will go through the full self-nomination process leading to a total burden of $205,273 ($881.00 × 233).
Qualified registries and QCDRs must comply with requirements on the submission of MIPS data to CMS. The burden associated with the qualified registry and QCDR submission requirements 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 us 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 noted in this section 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” to submit quality measures results and numerator and denominator data on MIPS eligible clinicians.
The following is a summary of the public comments received on our estimated burden for QCDR and registry self-nomination.
We assume that many of the QCDRs that previously participated in the self-nomination process for the CY 2017 Quality Payment Program will do so again for the CY 2018 Quality Payment Program and will not need to have as many follow-up discussions as in the previous year. However, because the estimate is an average, we maintained our estimate of 10 hours which we included in our CY 2017 burden estimates even though we believe continuing QCDRs will need fewer hours. The burden estimates in this section addresses time costs of data collection, not direct financial costs such as those related to measure updating.
After consideration of public comments, no changes were made to our estimated burden for QCDR and registry self-nomination compared to those presented in the CY 2018 Quality Payment Program proposed rule (82 FR 30216).
In the CY 2017 Quality Payment Program final rule (81 FR 77386), we finalized the definition, criteria, required forms, and vendor business requirements needed to participate in MIPS as a survey vendor. For purposes of MIPS, we defined 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 (81 FR 77386). At § 414.1400(i), we require that vendors undergo the CMS-approval process each year in which the survey vendor seeks to transmit survey measures data to us (81 FR 77386). We finalized the criteria for a CMS-approved survey vendor for the CAHPS for MIPS survey (81 FR 77386). In section II.C.10.e.(1) of this final rule with comment period, we finalized that beginning with the 2018 performance period and for future years, the vendor application deadline will be January 31st of the applicable performance year or a later date specified by CMS, which we do not anticipate would have any burden impact on the CMS-approved survey vendors.
We estimate that approximately 15 CMS-approved survey vendors will apply for the 2018 MIPS performance period. We estimate that it will take a survey vendor 10 hours to submit the information required for the CMS-approval process, including the completion of the Vendor Participation Form and compiling documentation, including the quality assurance plan, that demonstrates that they comply with Minimum Survey Vendor Business Requirements. This is comparable to the burden of the QCDR and qualified registry self-nomination process. As shown in Table 53, we assume that the survey vendor staff involved in collecting and submitting the information required for the CAHPS for MIPS certification will be computer systems analysts, who have an average labor cost of $88.10/hour. Therefore, assuming the total burden hours per CAHPS associated with the application process is 10 hours, the annual burden hours is 150 (15 survey vendors × 10 hours). We estimate that the total cost to each survey vendor associated with the application process will be approximately $881.00 ($88.10 per hour × 10 hours per survey vendor). We estimate that 15 survey vendors will go through the process leading to a total burden of $13,215 ($881.00 × 15 survey vendors).
Based on the assumptions previously discussed, we provide an estimated number of total annual burden hours and total annual cost burden associated with the survey vendor approval process in Table 53.
We received no public comments related to the burden estimates for the CMS-approved survey vendor application. The burden estimates have not been updated from the CY 2018 Quality Payment Program proposed rule(82 FR 30216).
Two groups of clinicians will submit quality data under MIPS: Those who submit as MIPS eligible clinicians and other eligible clinicians who opt to submit data voluntarily but will not be subject to MIPS payment adjustments.
Historically, the PQRS has never experienced 100 percent participation; the participation rate for 2015 was 69 percent.
Our burden estimates for data submission combine the burden for MIPS eligible clinicians and other clinicians submitting data voluntarily. Apart from clinicians that became QPs in the first QP performance period, we assume that clinicians will continue to submit quality data under the same submission mechanisms that they used under the 2016 PQRS. Further, as discussed in more detail in section IV.C. of this final rule with comment period when describing the burden for the virtual group application process, we assume that the approximately 80 TINs that elect to form the approximately 16 virtual groups will continue to use the same submission mechanism as they did when reporting under the 2016 PQRS, but the submission will be at the virtual group, rather than group level. Our burden estimates for the quality performance category do not include the burden for the quality data that APM Entities in MIPS APMs submit to fulfill the requirements of their models. Sections 3021 and 3022 of the Affordable Care Act state the Shared Savings Program and the testing, evaluation, and expansion of Innovation Center models are not subject to the PRA (42 U.S.C. 1395jjj and 42 U.S.C. 1315a(d)(3), respectively).
Table 54 provides our estimated counts of clinicians that will submit quality performance category data as MIPS individual clinicians, groups, or virtual groups in the 2018 MIPS performance period. The first step was to estimate the number of clinicians to submit as an individual clinician or group via each mechanism during the 2017 MIPS performance period using 2016 PQRS data on individuals and groups submitting through various mechanisms and excluding clinicians identified as QPs using the initial QP determination file as described in the 2017 Quality Payment Program final rule (81 FR 77444).
Based on these methods, Table 54 shows that in the 2018 MIPS performance period, an estimated 278,039 clinicians will submit as individuals via claims submission mechanisms; 255,228 clinicians will submit as individuals, or as part of groups or virtual groups via qualified registry or QCDR submission mechanisms; 131,133 clinicians will submit as individuals, or as part of groups or virtual groups via EHR submission mechanisms; and 93,867 clinicians will submit as part of groups via the CMS Web Interface.
Although we did not finalize multiple submission mechanisms within a performance category for the 2018 MIPS performance period, we are capturing the burden of any eligible clinician that may have historically submitted via multiple mechanisms, as we assume they would continue to submit via multiple mechanisms and that our MIPS scoring methodology would take the highest score. Hence, the estimated numbers of individual clinicians, groups, and virtual groups to submit via the various submission mechanisms are not mutually exclusive, and reflect the occurrence of individual clinicians or groups that submitted data via multiple mechanism under the 2016 PQRS.
Table 54 provides estimates of the number of clinicians to submit quality measures via each mechanism, regardless of whether they decide to submit as individual clinicians or as part of groups or virtual groups. Because our burden estimates for quality data submission assume that burden is reduced when clinicians elect to submit as part of a group or virtual group, we also separately estimate the expected number of clinicians to submit as individuals or part of groups or virtual groups.
Table 55 uses methods similar to those described for Table 54 to estimate the number of clinicians to submit as individual clinicians via each mechanism in Quality Payment Program Year 2. We estimate that approximately 278,039 clinicians will submit as individuals via claims submission mechanisms; approximately 104,281 clinicians will submit as individuals via qualified registry or QCDR submission mechanisms; and approximately 52,709 clinicians will submit as individuals via EHR submission mechanisms. Individual clinicians cannot elect to submit via CMS Web Interface. Consistent with the policy finalized in section II.C.7.a. of this final rule with comment period to score individual clinicians on quality measures independently for each submission mechanism submitted via multiple mechanisms, our columns in Table 55 are not mutually exclusive.
Table 56 provides our estimated counts of groups or virtual groups to submit quality data on behalf of clinicians via each mechanism in the 2018 MIPS performance period and reflects our assumption that the formation of virtual groups will reduce burden. Except for groups comprised entirely of QPs, we assume that groups that submitted quality data as groups under the 2016 PQRS will continue to submit quality data either as groups or virtual groups via the same submission mechanisms as they did as a group or TIN within a virtual group for the 2018 MIPS performance period. The first step in estimating the numbers of groups or virtual groups to submit via each mechanism in the 2018 MIPS performance period was to estimate the number of groups to submit on behalf of clinicians via each mechanism in the 2017 MIPS performance period. We used 2016 PQRS data on groups submitting on behalf of clinicians via various mechanisms and excluded groups comprised entirely of QPs using the initial QP determination file as described in the 2017 Quality Payment Program final rule (81 FR 77444). The second and third steps in Table 56 reflect our assumption that virtual groups will reduce the burden for quality data submission by reducing the number of organizations to submit quality data on behalf of clinicians. We assume that 40 groups that previously submitted on behalf of clinicians via QCDR or qualified registry submission mechanisms will elect to form 8 virtual groups that will submit via QCDR and qualified registry submission mechanisms. We assume that another 40 groups that previously submitted on behalf of clinicians via EHR submission mechanisms will elect to form another 8 virtual groups via EHR submission mechanisms. Hence, the third step in Table 56 is to subtract out the estimated number of groups under each submission mechanism that will elect to form virtual groups, and the fourth step in Table 56 is to add in the estimated number of virtual groups that will submit on behalf of clinicians via each submission mechanism.
Specifically, we assumed that 2,936 groups and virtual groups will submit data via QCDR/registry submission mechanisms on behalf of 150,957 clinicians; 1,509 groups and virtual groups will submit via EHR submission mechanisms on behalf of 78,424 eligible clinicians; and 296 groups will submit data via the CMS Web Interface on behalf of 93,867 clinicians. Groups cannot elect to submit via claims submission mechanism.
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 practice workflows is expected to vary along with the number of measures that are potentially applicable to a given clinician's practice. Further, these 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 submitting the quality measures will vary depending on the submission method selected by the clinician, group, or virtual group. As such, we break down the burden estimates by clinicians, groups, and virtual groups by the submission method used.
We anticipate that clinicians and groups using QCDR, qualified registry, and EHR submission mechanisms will have the same start-up costs related to reviewing measure specifications. As such, we estimate for clinicians, groups, and virtual groups using any of these three submission mechanisms a total of 6 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 practice work flows. Building on data in a recent article, Casalino et al. (2016), we assume that a range of expertise is needed to review quality measure specifications: 2 hours of a practice administrator's time, 1 hour of a clinician's time, 1 hour of an LPN/medical assistant's time, 1 hour of a computer systems analyst's time, and 1
For the claims submission mechanism, we estimate that the start-up cost for a MIPS eligible clinician's practice to review measure specifications is $684.90, including 3 hours of a practice administrator's time (3 hours × $105.16=$315.48), 1 hour of a computer systems analyst time (1 hour × $88.10/hou r= $88.10), 1 hour of an LPN/medical assistant's time (1 hour × $43.12), 1 hour of a billing clerk's time (1 hour × $36.12/hour = $36.12) and 1 hour of a clinician's time (1 hour × $202.08/hour = $202.08). These start-up costs pertain to the specific quality submission methods below, and hence appear in the burden estimate tables.
For the purposes of our burden estimates for the claims, qualified registry and QCDR, and EHR submission mechanisms, we also assume that, on average, each clinician, group, or virtual group will submit 6 quality measures.
Our estimated number of respondents for the QCDR/qualified registry and EHR submission mechanisms increased relative to the estimates in the CY 2017 Quality Payment Program final rule. Our estimated respondents for the claims submission mechanism has declined relative to the CY 2017 Quality Payment Program final rule in part because we have excluded QPs from our burden estimates; in the CY 2017 Quality Payment Program final rule, QPs were included in our burden estimates due to data limitations. The number of respondents for CMS Web Interface has declined relative to the estimates in the CY 2017 Quality Payment Program final rule because our estimates now exclude QPs and CMS Web Interface data submitted in 2016 by Shared Savings Program and Next Generation and Pioneer ACOs to fulfill the requirement of their models. As noted in this section of the CY 2018 Quality Payment Program final rule with comment period, information collections associated with the Shared Savings Program and the testing, evaluation, and expansion of CMS Innovation Center models are not subject to the PRA.
The following is a summary of the public comments received regarding our request for information on our general burden estimates regarding the quality performance category.
Our estimated data submission burden for the Quality Payment Program, approximately $695 million, is significantly lower than the estimated $15.4 billion cost of quality reporting programs described in the Casalino et al. (2016). Our burden estimates are based on prorated versions of the estimates for reviewing measure specifications in Casalino et al., “US Physician Practices Spend More than $15.4 Billion Annually to Report Quality Measures,” Health Affairs, 35, no. 3 (2016): 401-406. The estimates were annualized to 50 weeks per year, and then prorated to reflect that Medicare revenue is 30 percent of all revenue paid by insurers, and then adjusted to reflect that the decrease from 9 required quality measures under PQRS to 6 required measures under MIPS. We also refer to the CY 2017 Quality Payment Program final rule (81 FR 77502), where we provided a footnote that describes the prorated assumptions which are also included in this final rule with comment period burden estimates.
After consideration of public comments, no changes were made to the quality performance category burden estimate in response to comments specific to that performance category. The burden estimates were updated from the CY 2018 Quality Payment Program proposed rule (82 FR 30218 to 30219) to reflect updated data sources on the number of respondents, and to reflect that we are not finalizing the policy to allow facility-based
As noted in Table 54, based on 2016 PQRS data and 2017 MIPS eligibility data, we assume that 278,039 individual clinicians will submit quality data via claims. We anticipate the claims submission process for MIPS will be operationally similar to the way the claims submission process 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 0938-1197.
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 57, we also estimate that the cost of quality data submission using claims will range from $19.38 (0.22 hours × $88.10) to $951.48 (10.8 hours × $88.10). The total estimated annual cost per clinician ranges from the minimum burden estimate of $704.28 to a maximum burden estimate of $1,636.38. The burden will involve becoming familiar with MIPS data submission requirements. As noted in Table 57, we believe that the start-up cost for a clinician's practice to review measure specifications totals 7 hours, which includes 3 hours of a practice administrator's time (3 hours × $105.16 = $315.48), 1 hour of a clinician's time (1 hour × $202.08/hour = $202.08), 1 hour of an LPN/medical assistant's time (1 hour × $43.12 = $43.12), 1 hour of a computer systems analyst's time (1 hour × $88.10 = $88.10), and 1 hour of a billing clerk's time (1 hour × $36.12/hour = $36.12).
Considering both data submission and start-up costs, the total estimated burden hours per clinician ranges from a minimum of 7.22 hours (0.22 + 3 + 1 + 1 + 1 + 1) to a maximum of 17.8 hours (10.8 + 3 + 1 + 1 + 1 + 1). The total estimated annual cost per clinician ranges from the minimum estimate of $704.28 ($19.38 + $315.48 + $88.10 + $43.12 + $36.12 + $202.08) to a maximum estimate of $1,636.38 ($951.48 + $315.48 + $88.10 + $43.12 + $36.12 + $202.08). Therefore, total annual burden cost is estimated to range from a minimum burden estimate of $195,817,307 (278,039 × $704.28) to a maximum burden estimate of $454,977,459 (278,039 × $1,636.38).
Based on the assumptions discussed in this section of this final rule with comment period, Table 57 summarizes the range of total annual burden associated with clinicians using the claims submission mechanism.
We received no public comment specific to our burden estimates for the quality performance category claims submission mechanism. The burden estimates were updated from the CY 2018 Quality Payment Program proposed rule to reflect updated data sources on the number of respondents, and to reflect that we are not finalizing the policy to allow facility-based measurement until the 2019 MIPS performance period.
As noted in Table 54 and based on the 2016 PQRS data and 2017 MIPS eligibility data, we assume that 255,228 clinicians will submit quality data as individuals, groups, or virtual groups via qualified registry or QCDR submissions. Of these, we expect 104,281 clinicians, as shown in Table 55, to submit as individuals and 2,936 groups, as shown in Table 56, are expected to submit on behalf of the remaining 150,947 clinicians. Given that the number of measures required is the
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 (individual clinicians, groups, and virtual groups) to become familiar with MIPS submission requirements and, in some cases, specialty measure sets and QCDR measures. Therefore, we believe that the costs for an individual clinician or group to review measure specifications and submit quality data total $843.74. For review costs and data submission costs, this total includes 3 hours per respondent to submit quality data (3 hours × $88.10/hour = $264.00), 2 hours of a practice administrator's time (2 hours × $105.16/hour = $210.32), 1 hour of a computer systems analyst's time (1 hour × $88.10/hour = $88.10), 1 hour of an LPN/medical assistant's time, (1 hour × $43.12/hour = $43.12), 1 hour of a billing clerk's time (1 hour × $36.12/hour = $36.12) and 1 hour of a clinician's time (1 hour × $202.08). Clinicians, groups, and virtual 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 us 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 $7.31, at a computer systems analyst's labor rate (.083 hours × $88.10/hour). Hence, we estimate 9.083 burden hours per respondent, with annual total burden hours of 973,852 (9.083 burden hours × 107,217 respondents). The total estimated annual cost per respondent is estimated to be approximately $851.05. Therefore, total annual burden cost is estimated to be $91,247,028 (107,217 × $851.05). Based on these assumptions, we have estimated in Table 58 the burden for these submissions.
The following is a summary of the public comments received regarding our request for information on our qualified registry/QCDR burden estimates regarding the quality performance category.
The burden estimates in this section address time costs, not direct financial costs for data submission to registries and QCDRs. The CY 2017 Quality Payment Program final rule established a policy to have QCDRs and registries publish fees (81 FR 77505). The fees are published at
Our burden estimates for clinicians submitting through multiple or single submission mechanism reflect the time costs, but not the direct financial costs of data submission. In the CY 2017 Quality Payment Program final rule (81 FR 77505) we finalized a policy to post QCDR's self-reported costs for MIPS eligible clinicians or groups to use the QCDR on the CMS Web site alongside their organizational contact information and the services and measures offered. In summary, no changes were made to the quality performance category qualified registry/QCDR burden estimate in response to comments received. The burden estimates were updated from the CY 2018 Quality Payment Program proposed rule to reflect updated data sources on the number of respondents, and to reflect that we are not finalizing the policy to allow facility-based measurement until the 2019 MIPS performance period.
After consideration of public comments, we made no changes to our qualified registry/QCDR burden estimates. The burden estimates were updated from the CY 2018 Quality Payment Program proposed rule (82 FR 30222) to reflect updated data sources on the number of respondents, and to reflect that we are not finalizing the policy to allow facility-based measurement until the 2019 MIPS performance period.
As noted in Tables 54, 55 and 56, based on 2016 PQRS data and 2017 MIPS eligibility data, we assume that 131,133 clinicians will submit quality data as individuals or groups via EHR submissions; 52,709 clinicians are expected to submit as individuals; and 1,509 groups are expected to submit on behalf of 78,424 clinicians. We expect the burden to be the same for each respondent submitting data via EHR, 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 us from their EHR or utilize an EHR data submission vendor to submit the data to us on the clinician's or group's behalf.
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, groups, and virtual groups who submit their data directly to us from their CEHRT and clinicians, groups, and virtual groups who use an EHR data submission vendor to submit the data on their behalf. To submit data to us directly from their CEHRT, clinicians, groups, and virtual groups must have access to a CMS-specified identity management system which we believe takes less than 1 hour to obtain. Once a clinician or group has an account for this CMS-specified identity management system, they will need to extract the necessary clinical data from their EHR, and submit the necessary data to the CMS-designated clinical data warehouse.
We estimate that obtaining an account on a CMS-specified identity management system will require 1 hour per respondent for a cost of $88.10 (1 hour × $88.10/hour). For submitting the actual data file, we believe that this will take clinicians or groups no more than 2 hours per respondent for a cost of submission of $176.20 (2 hours × $88.10/hour). The burden will involve becoming familiar with MIPS submission. We believe that the start-up cost for a clinician or group to review measure specifications is a total of 6 hours which includes 2 hours of a practice administrator's time (2 hours × $105.16/hour = $210.32), 1 hour of a clinician's time (1 hour × $202.08/hour = $202.08), 1 hour of a computer systems analyst's time (1 hour × $88.10/hour = $88.10), 1 hour of an LPN/medical assistant's time (1 hour × $43.12/hour = $43.12), and 1 hour of a billing clerk's time (1 hour × $36.12/hour = $36.12). Hence, we estimated 9 total burden hours per respondent with annual total burden hours of 487,962 (9 burden hours × 54,218 respondents). The total estimated annual cost per respondent is estimated to be $844.04. Therefore, total annual burden cost is estimated to be $45,762,161 = (54,218 respondents × $844.04).
Based on the assumptions discussed in section II.C.6.a of this final rule with comment period, we have estimated the burden for the quality data submission using EHR submission mechanism in Table 59.
The following is a summary of the public comments received regarding our request for information on our EHR submission mechanism burden estimates regarding the quality performance category.
After consideration of public comments, we made no changes to the quality performance category EHR submission mechanism burden estimate. The burden estimates were updated from the CY 2018 Quality Payment Program proposed rule (82 FR 30222) to reflect updated data sources on the number of respondents, and to reflect that we are not finalizing the policy to allow facility-based measurement until the 2019 MIPS performance period.
Based on 2016 PQRS data and as shown in Table 60, we assume that 296 groups will submit quality data via the CMS Web Interface in the 2018 MIPS performance period. We anticipate that approximately 93,867 clinicians will be represented.
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 74 hours of a computer systems analyst's time to submit quality measures data via the CMS Web Interface at a cost of $88.10 per hour, for a total cost of $6,519 (74 hours × $88.10/hour). Our estimate of 74 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 (we will partially pre-populate the CMS Web Interface with claims data from their Medicare Part A and B beneficiaries). The patient data either can be manually entered or uploaded into the CMS Web Interface via a standard file format, which can be populated by CEHRT. Because the CMS API will streamline the measure submission process for many groups, we have reduced our estimate of the computer system's analyst time needed for submission from 79 hours in the CY 2017 Quality Payment Program final rule to 74 hours. 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) for each measure, we assume that entering or uploading data for one Medicare beneficiary across all the measures requires approximately 18 minutes of a computer systems analyst's time (74 hours ÷ 248 patients for each measure).
The total annual burden hours are estimated to be 21,904 (296 groups × 74 annual hours), and the total annual burden cost is estimated to be $1,929,624 (296 groups × $6,519).
Based on the assumptions discussed in this section of the CY 2018 Quality Payment Program proposed rule, we have calculated in Table 60 the following burden estimate for groups submitting to MIPS with the CMS Web Interface.
The following is a summary of the public comments received regarding our request for information on our Web Interface submission mechanism burden estimates regarding the quality performance category.
After consideration of public comments, we made no changes to the quality performance category Web Interface submission mechanism burden estimate. The burden estimates were updated from the CY 2018 Quality Payment Program proposed rule (82 FR 30223) to reflect updated data sources on the number of respondents.
Under MIPS, groups of 2 or more clinicians can elect to contract with a CMS-approved survey vendor and use the CAHPS for MIPS survey as one of their 6 required quality measures. Beneficiaries that choose to respond to the CAHPS for MIPS survey will experience burden.
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 $23.86. Although most Medicare beneficiaries are retired, we believe that their time value is unlikely to depart significantly from prior earnings expense, and we have used the average hourly wage to compute the dollar cost estimate for these burden hours.
Under the 2018 MIPS performance period, 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 for reporting period 2016.
In section II.C.6.b.(3)(1)(iii) of this final rule with comment period, we are establishing a policy to use a shorter version of the CAHPS for MIPS survey with 58 items, as compared to 81 items for the version that will be used in the transition year. The shorter survey is estimated to require an average administration time of 12.9 minutes (or 0.22 hours) in English (at a pace of 4.5 items per minute). We assume the Spanish survey would require 15.5 minutes (assuming 20 percent more words in the Spanish translation). Because less than 1 percent of surveys were administered in Spanish for reporting year 2016, our burden estimate reflects the length of the English survey. Our finalized policy will reduce beneficiary burden compared to the transition year; we estimate that the 81-item survey requires an average administration time of 18 minutes in English and 21.6 minutes in Spanish. Compared to the survey for reporting year 2016, this is a reduction of 5.1 minutes (18 minutes to 12.9 minutes) in administration time for the English version and a reduction of 6.1 (21.6 minutes—15.5 minutes) minutes in administration time for the Spanish version.
Given that we expect approximately 132,307 respondents per year, the annual total burden hours are estimated to be 29,108 hours (132,307 respondents × 0.22 burden hours per respondent). The estimated total burden annual burden cost is $694,612 (132,307 × $5.25).
We received no public comments related to the burden estimates for beneficiary participation in the CAHPS for MIPS survey. The burden estimates have not been changed from the CY 2018 Quality Payment Program proposed rule (82 FR 30224).
Groups interested in participating in MIPS using the CMS Web Interface for the first time must complete an on-line registration process. After first time registration, groups will only need to opt out if they are not going to continue to submit via the CMS Web Interface. In Table 62 we estimate that the registration process for groups under MIPS involves approximately 1 hour of administrative staff time per group. We assume that a billing clerk will be responsible for registering the group and that, therefore, this process has an average computer systems analyst labor cost of $88.10 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 associated with the group registration process to be approximately $88.10 ($88.10 per hour × 1 hour per group). We assume that approximately 10 groups will elect to use the CMS Web Interface submission mechanism in the 2018 MIPS performance period. The total annual burden hours are estimated to be 10 (10 groups × 1 annual hour), and the total annual burden cost is estimated to be $881.00 (10 groups × $88.10).
We received no public comments related to the burden estimates for group registration for the CMS Web Interface. The burden estimates have not been updated from the CY 2018 Quality Payment Program proposed rule (82 FR 30224).
Under MIPS, the CAHPS for MIPS survey counts for 1 measure towards the MIPS quality performance category and, as a patient experience measure, also fulfills the requirement to submit at least one high priority measure in the absence of an applicable outcome measure. Groups that wish to administer the CAHPS for MIPS survey must register by June of the applicable 12-month performance period, and electronically notify CMS of which vendor they have selected to administer the survey on their behalf. In the 2018 MIPS performance period, we assume that 461 groups will enroll in the MIPS for CAHPS survey.
As shown in Table 63, we assume that the staff involved in the group registration for CAHPS for MIPS Survey will mainly be computer systems analysts or their equivalent, who have an average labor cost of $88.10/hour. We assume the CAHPS for MIPS Survey registration burden estimate includes the time to register for the survey as well as select the CAHPS for MIPS Survey vendor. Therefore, assuming the total burden hours per registration is 1 hour and 0.5 hours to select the CAHPS for MIPS Survey vendor that will be used and electronically notify CMS of their selection, the total burden hours for CAHPS for MIPS registration is 1.5. We estimate the total annual burden hours as 692 (461 groups × 1.5 hours). We estimate the cost per group for CAHPS for MIPS Survey registration is $132.15 ($88.10 × 1.5 hours). We estimate that the total cost associated with the registration process is $60,921 ($132.15 per hour × 461 hours per group).
The following is a summary of the public comments received regarding our estimated burden for the group registration for the CAHPS for MIPS survey.
Because the burden estimates in this section addresses time costs, not direct financial costs, no changes were made to the burden estimate for group registration for CAHPS for MIPS survey as a result of this comment.
We received no public comments related to the burden estimates for group registration for the CAHPS for MIPS Survey. The burden estimates have not been updated from the CY 2018 Quality Payment Program proposed rule (82 FR 30225).
During the 2018 MIPS performance period, clinicians, groups, and virtual groups can submit advancing care information data through qualified registry, QCDR, EHR, CMS Web Interface, and attestation data submission methods. We have worked to further align the advancing care information performance category with other MIPS performance categories. We anticipate that most organizations will use the same data submission mechanism for the advancing care information and quality performance categories and that the clinicians, practice managers, and computer systems analysts involved in supporting the quality data submission will also support the advancing care information data submission process. Hence, the burden estimate for the submission of advancing care information data below shows only incremental hours required above and beyond the time already accounted for in the quality data submission process. While this analysis assesses burden by performance category and submission mechanism, we emphasize that MIPS is a consolidated program and submission analysis and decisions are expected to be made for the program as a whole.
As stated in the CY 2017 Quality Payment Program final rule, some MIPS eligible clinicians may not have sufficient measures applicable and available to them for the advancing care information performance category, and as such, they may apply to have the advancing care information performance category re-weighted to zero in the following circumstances: insufficient internet connectivity, extreme and uncontrollable circumstances, lack of control over the availability of CEHRT (81 FR 77240 through 77243). As described in section II.C.6.f.(7) of this final rule with comment period, we are establishing a policy to allow MIPS eligible clinicians to apply to have their advancing care information performance category re-weighted to zero due to a significant hardship exception or exception for decertified EHR technology. We are also establishing a policy that MIPS eligible clinicians who are in small practices (15 or fewer clinicians) may, beginning with the 2018 MIPS performance period and 2020 MIPS payment year, request a reweighting to zero for the advancing care information performance category due to a significant hardship. We are finalizing our policy to rely on section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act, as our authority for the significant hardship exceptions.
Table 64 shows the estimated annualized burden for clinicians to apply for a reweighting to zero of their advancing care information performance category due to a significant hardship exception or as a result of a decertification of an EHR, as well as an application for significant hardship by small practices. Based on 2016 data from the Medicare EHR Incentive Program and the first 2019 payment year MIPS eligibility and special status file, we assume 40,645 respondents (eligible clinicians, groups, or virtual groups) will submit a request for reweighting to zero of their advancing care information performance category due to a significant hardship exception, decertification of an EHR or significant hardship for small practices through the Quality Payment Program. We estimate that 5,812 respondents (eligible clinicians, groups, or virtual groups) will submit a request for a reweighting to zero for the advancing care information performance category due to extreme and uncontrollable circumstances or as a result of a decertification of an EHR, and 34,833 respondents will submit a request for a reweighting to zero for the advancing care information performance category as a small practice. The application to request a reweighting to zero for the advancing care information performance category due to significant hardship is a short online form that requires identifying which type of hardship or if decertification of an EHR applies and a description of how the circumstances impair the ability to submit the advancing care information data, as well as some proof of circumstances beyond the submitter's control. The estimate to submit this application is 0.5 hours of a computer system analyst's time. Given that we expect 40,645 applications per year, the annual total burden hours are estimated to be 20,323 hours (40,645 respondents × 0.5 burden hours per respondent). The estimated total annual burden is $1,790,412 (40,645 × $44.05).
We received no public comments related to the burden estimates for application for reweighting for the advancing care information performance category. The burden estimates have not been updated from the CY 2018 Quality
A variety of organizations will submit advancing care information data on behalf of clinicians. Clinicians not participating in a MIPS APM can submit as individuals or as part of a group or virtual group. Group TINs may submit advancing care information data on behalf of clinicians in MIPS APMs, or, except for participants in the Shared Savings Program, clinicians in MIPS APMs may submit advancing care information performance category data individually. Because group TINs in APM Entities will be submitting advancing care information 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 list of APMs that are MIPS APMs on the Quality Payment Program Web site,
As shown in Table 65, based on data from the 2015 and 2016 Medicare and Medicaid EHR Incentive Programs, the 2016 PQRS data, and 2017 MIPS eligibility data, we estimate that 195,022 individual MIPS eligible clinicians and 668 groups or virtual groups, representing 101,873 MIPS eligible clinicians, will submit advancing care information data. These estimates reflect that under the policies finalized in CY 2017 Quality Payment Program final rule, certain MIPS eligible clinicians will be eligible for automatic reweighting of their advancing care information performance category score to zero, including MIPS eligible clinicians that practice primarily in the hospital, physician assistants, nurse practitioners, clinician nurse specialists, certified registered nurse anesthetists, and non-patient facing clinicians. These estimates also account for the significant hardships finalized in the CY 2017 Quality Payment Program final rule and the final policies adopted in this rule for significant hardship exceptions, including for MIPS eligible clinicians in small practices, as well as exceptions due to decertification of an EHR. Due to data limitations, our estimate of the number of clinicians to submit advancing care information data does not account for our policy finalized in this final rule with comment period to rely on section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act, to assign a scoring weight of zero percent for the advancing care information performance category for MIPS eligible clinicians who are determined to be based in ambulatory surgical centers (ASCs) (section II.C.6.f.(7)(a) of this final rule with comment period).
Further, we anticipate that the 480 Shared Savings Program ACOs will submit data at the ACO participant group TIN-level, for a total of 15,945 group TINs. We anticipate that the three APM Entities electing the one-sided track in the CEC model will submit data at the group TIN-level, for an estimated total of 100 group TINs submitting data. We anticipate that the 195 APM Entities in the OCM (one-sided risk arrangement) will submit data at APM Entity level, for an estimated total of 6,478 group TINs. Based on the initial QP determination file, we estimate 2 APM Entities in the CPC+ model will submit at the group TIN-level, for an estimated total of 2 group TINs submitting data. Based on the initial QP determination file, we assume that 1 CPC+ APM entity will submit data because one or more of its participants is a partial QP, and that 1 CPC+ APM Entity will submit data because some of its participants qualify as either as QPs or partial QPs. The total estimated number of respondents is estimated at 218,215.
We received no public comments
In Table 66, we estimate that up to approximately 218,215 respondents will be submitting data under the advancing care information performance category, 195,022 clinicians, 668 groups or virtual groups, 15,945 group TINs within the Shared Savings Program ACOs, 100 group TINs within the APM Entity participating in CECs in the one-sided risk track, and 6,478 group TINs within the OCM (one-sided risk arrangement), and 2 CPC+ group TINs. We estimate this is a significant reduction in respondents from the 2017 MIPS performance period as a result of our
In the CY 2017 Quality Payment Program final rule, our burden estimates assumed all clinicians who submitted quality data would also submit under the advancing care information performance category. For this final rule with comment period, MIPS special status eligibility data were available to model exceptions. The majority (267,065) of the difference in our estimated number of respondents is due to the availability of MIPS special status data to identify clinicians and groups that would also not need to report advancing care information data under transition year policies, including hospital-based eligible clinicians, clinician types eligible for automatic reweighting of their advancing care information performance category score, non-patient facing clinicians, and clinicians facing a significant hardship. The remaining decline in respondents is due to policies established in this final rule with comment period, including 42,951 respondents who would be excluded under the finalized significant hardship exception for small practices. We also do not include clinicians in ambulatory surgical centers.
Our burden estimates in the CY 2017 Quality Payment Program final rule assumed that during the transition year, 3 hours of clinician time would be required to collect and submit advancing care information performance category data. We anticipate that the year-over-year consistency of data submission processes, measures, and activities and the further alignment of the advancing care information performance category with other performance categories will reduce the clinician time needed under this performance category in the 2018 MIPS performance period. Further, for some practices the staff mix requirements in the 2018 MIPS performance period may be driven more by transition to 2015 CEHRT. Therefore, as shown in Table 66, the total burden hours for an organization to submit data on the specified Advancing Care Information Objectives and Measures is estimated to be 3 incremental hours of a computer analyst's time above and beyond the clinician, practice manager, and computer system's analyst time required to submit quality data. The total estimated burden hours are 654,645 (218,215 respondents × 3 hours). At a computer systems analyst's hourly rate, the total burden cost is $57,674,225 (218,215 × $264.30/hour).
The following is a summary of the public comments received regarding our request for information on our burden estimates regarding the advancing care information performance category.
After consideration of public comments, no changes were made to the advancing care information performance category burden estimates from the CY 2018 Quality Payment proposed rules (82 FR 30227) as a result of comments specific to that performance category.
The burden estimates were updated from the PQRS 2016 data to reflect updated data sources on the number of respondents. Our decision not to finalize implementing facility-based measurement (82 FR 30125) until the beginning of the 2019 performance period does not affect these numbers because we had selected facility-based clinicians from a subset of clinicians that could qualify for automatic reweighting.
Requirements for submitting improvement activities did not exist in the legacy programs replaced by MIPS, and we do not have historical data
A variety of organizations and in some cases, individual clinicians, will submit improvement activity performance category data. For clinicians who are not part of APMs, we assume that clinicians submitting quality data as part of a group or virtual group through the QCDR and registry, EHR, and CMS Web Interface submission mechanisms will also submit improvement activities data. As finalized in the CY 2017 Quality Payment Program final rule (82 FR 77264), APM Entities only need to report improvement activities data if the CMS-assigned improvement activities score is below the maximum improvement activities score. Our CY 2018 Quality Payment Program final rule burden estimates assume all ACOs will receive the maximum CMS-assigned improvement activities score.
In the CY 2018 Quality Payment Program proposed rule (82 FR 30228), we estimated 520,654 clinicians will submit improvement activities as individuals during the 2018 MIPS performance period, an estimated 3,818 groups to submit improvement activities on behalf of clinicians during the 2018 MIPS performance period, and an additional 16 virtual groups to submit improvement activities, resulting in 524,488 total respondents. However, the burden estimates have been updated from the CY 2018 Quality Payment Program proposed rule to reflect updated data sources on the number of respondents.
In this final rule with comment period, we are updating our estimates to reflect an additional 923 groups for a total of 4,741 based using the more recent 2016 PQRS data and 85,625 fewer clinicians reporting as individuals for the improvement activities performance category.
As represented in Table 67, we estimate 435,029 clinicians will submit improvement activities as individuals during the 2018 MIPS performance period, an estimated 4,741 groups to submit improvement activities on behalf of clinicians during the 2018 MIPS performance period, and an additional 16 virtual groups to submit improvement activities, resulting in 439,786 total respondents. The burden estimates assume there will be no improvement activities burden for MIPS APM participants. We will assign the improvement activities performance category score at the APM level. We assume that the MIPS APM models for the 2018 MIPS performance period would qualify for the maximum improvement activities performance category score and the APM Entities would not need to submit any additional improvement activities.
In Table 68, we estimate that approximately 439,786 respondents will be submitting data under the improvement activities performance category. Our burden estimates in the CY 2017 Quality Payment Program final rule assumed that during the transition year, 2 hours of clinician time would be required to submit data on the specified improvement activities. For this final rule with comment period, our burden estimate assumes that the total burden hours to submit data on the specified improvement activities will be 1 hour of computer system analyst time in addition to time spent on other performance categories. Our revised estimate is based on changes we made to include additional new high-weighted activities that were in response to comments from stakeholders (82 FR 30052). The addition of more high-weighted activities means that some clinicians will need to spend less time selecting activities because they may be able to select only two high-weighted activities instead of four medium-weighted activities.
Additionally, the same improvement activity may be reported across multiple performance periods so many MIPS eligible clinicians will not have any additional information to develop for the 2018 MIPS performance period. The total estimated burden hours are
The following is a summary of the public comments received regarding our burden estimates for submission of improvement activities.
After consideration of public comments, we made no changes to the improvement activities submission burden estimates from the CY 2018 Quality Payment Program proposed rule (82 FR 30228). The burden estimates were updated from the CY 2018 Quality Payment Program proposed rule to reflect updated data sources on the number of respondents.
For the 2018 MIPS performance period, we finalizing to formalize to allow clinicians, groups, and other relevant stakeholders to nominate new improvement activities using a nomination form provided on the Quality Payment Program Web site at
We did not receive comments specific to our burden estimates for nomination of improvement activities. The burden estimates have not been updated from the CY 2018 Quality Payment Program proposed rule (82 FR 30229).
The cost performance category relies on administrative claims data. The Medicare Parts A and B claims submission process is used to collect data on cost measures from MIPS eligible clinicians. MIPS eligible clinicians are not requested 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. We did not receive comments specific to cost performance category and no changes were made to this section.
APM Entities may face a data submission burden under MIPS related to Partial QP elections. Advanced APM participants will be notified about their QP or Partial QP status before the end of the performance period. For Advanced APMs the burden of partial QP election would be incurred by a representative of the participating APM Entity. For the purposes of this burden estimate, we assume that all MIPS
Based on our analyses of the initial QP determination file as described in the 2017 Quality Payment Program final rule (81 FR 77444), we assume that approximately 17 APM Entities will face the data submission requirement in the 2018 performance period.
As shown in Table 70, we assume that 17 APM Entities will make the election to participate as a partial QP in MIPS. We estimate it will take the APM Entity representative 15 minutes to make this election. Using a computer systems analyst's hourly labor cost, we estimate a total burden cost of just $375 (17 participant × $22.03).
We did not receive comments specific to our burden estimates for partial QP elections. Our burden estimates for partial QP elections have not been changed from the CY 2018 Quality Payment Program proposed rule (82 FR 30229).
Beginning in Quality Payment Program Year 3, the All-Payer Combination Option will be an available pathway to QP status for eligible clinicians participating sufficiently in Advanced APMs and Other Payer Advanced APMs. The All-Payer Combination Option allows for eligible clinicians to achieve QP status through their participation in both Advanced APMs and Other Payer Advanced APMs. In order to include an eligible clinician's participation in Other Payer Advanced APMs in their QP threshold score, we will need to determine if certain payment arrangements with other payers meet the criteria to be Other Payer Advanced APMs. To provide eligible clinicians with advanced notice prior to the start of the 2019 performance period, and to allow other payers to be involved prospectively in the process, we finalized in section II.D.6.c.(1)(b) of this final rule with comment period a payer-initiated identification process for identifying payment arrangements that qualify as Other Payer Advanced APMs. This payer-initiated identification process of Other Payer Advanced APMs will begin in CY 2018, and determinations would be applicable for the Quality Payment Program Year 3.
As shown in Table 71, we estimate that 300 other payer arrangements will be submitted (50 Medicaid payers, 150 Medicare Advantage Organizations, and 100 Multi-payers) for identification as Other Payer Advanced APMs. The estimated burden to apply is 10 hours per payment arrangement, for a total annual burden hours of 3,000 (300 X 100). We estimate a total cost per payer of $881.00 using a computer system analyst's rate of $88.10/hour (10 X 81.10). The total annual burden cost for all other payers is $264,300 (300 X $881.00).
The following is a summary of the public comments received regarding our request for information on our burden estimates for Other Payer Advanced APM identification: Payer-Initiated Process.
After consideration of public comments, we made no changes to the Other Payer Advanced APM Identification: Payer-Initiated Process burden from the CY 2018 Quality Payment Program proposed rule (82 FR 30230), and have added the burden for the Medicaid specific Eligible Clinician Initiated Process in this section of the final rule with comment period.
Beginning in Quality Payment Program Year 3, the All-Payer Combination Option will be an available pathway to QP status for eligible clinicians participating sufficiently in Advanced APMs and Other Payer Advanced APMs. The All-Payer Combination Option allows for eligible clinicians to achieve QP status through their participation in both Advanced APMs and Other Payer Advanced APMs. In order to include an eligible clinician's participation in Other Payer Advanced APMs in their QP threshold score, we will need to determine if certain payment arrangements with other payers meet the criteria to be Other Payer Advanced APMs.
To provide eligible clinicians with advanced notice prior to the start of the 2019 performance period, and to allow other payers to be involved prospectively in the process, we finalized in section II.D.6.c.(1) of this final rule with comment period a payer-initiated identification process for identifying payment arrangements that qualify as Other Payer Advanced APMs. However, to appropriately implement the Title XIX exclusions, we determined it was not feasible to allow APM Entities and eligible clinicians to request determinations for Title XIX payment arrangements after the conclusion of the All-Payer QP. To do so would mean that a single clinician requesting a determination for a previously unknown Medicaid APM or Medicaid Medical Home Model that meets the Other Payer Advanced APM criteria could unexpectedly affect QP threshold calculations for every other clinician in that state (or county) as described in section II.D.6.c.(3)(b) of the proposed rule. Thus, we also finalized in section II.D.6.c.(3) of this final rule with comment period that APM Entities and eligible clinicians may request determinations for any Medicaid payment arrangements in which they are participating at an earlier point, prior to the start of the 2019 performance period. This would allow all clinicians in a given state or county to know before the beginning of the performance period whether their Title XIX payments and patients would be excluded from the all-payer calculations that are used for QP determinations for the year under the All-Payer Combination Option. This Medicaid specific eligible clinician-initiated determination process of Other Payer Advanced APMs will also begin in CY 2018, and determinations would be applicable for the Quality Payment Program Year 3.
As shown in Table 72, we estimate that 75 other payer arrangements will be submitted by APM Entities and eligible clinicians for identification as Other Payer Advanced APMs. The estimated burden to apply is 10 hours per payment arrangement, for a total annual burden hours of 1,500 (150 × 10). We estimate a total cost per payer of $881.00 using a computer system analyst's rate of $88.10/hour (10 × 81.10). The total annual burden cost for all other payers is $66,075 (75 × $881.00).
We estimate 22,400 clinicians and groups who will voluntarily participate in MIPS but also will elect not to participate in public reporting. Table 73 shows that for these voluntary participants, they may submit a request to opt out which is estimated at 0.25 hours of a computer system analyst's labor rate of $88.10. The total annual burden hours for opting out is estimated at 5,600 hours (22,400 × 0.25). The total annual burden cost for opting out for all requesters is estimated at $493,472 (22,400 × $22.03).
We did not receive comments specific to our burden estimates for voluntary participants to elect opt out of performance data display on Physician Compare. The burden estimates are unchanged from the CY 2018 Quality Payment Program proposed rule (82 FR 30230).
Table 74 includes our CY 2018 Quality Payment Program final rule with comment period burden estimates for annual recordkeeping and data submission of 7,589,445 hours with total labor cost of $694,183,802. In order to understand the burden implications of the policies finalized in this rule, we have also estimated a baseline burden of continuing the policies and information collections set forth in the CY 2017 Quality Payment Program final rule into the 2018 performance period. This estimated baseline burden of 7,760,708 hours and a total labor cost of $708,101,886 is lower than the burden approved for information collection related to the CY 2017 Quality Payment Program final rule
We estimate that this final rule with comment period will decrease burden by 171,264 hours and $13.9 million in labor costs relative to the estimated baseline of continued transition year policies. The Quality Payment Program Year 2 reduction in burden based on policies established in this final rule reflects several finalized policies, including our finalized policy for a new significant hardship exception for small practices for the advancing care information performance category, reduced length of the CAHPS survey and the finalized policy to allow MIPS eligible clinicians to form virtual groups, which would create efficiencies in data submission.
We did not receive comments specific to our summary of annual burden estimates. We have updated the numbers to reflect updates based on 2016 data and to reflect new assumptions, but no other changes were made.
We have submitted a copy of this rule's information collection and recordkeeping requirements to OMB for review and approval. These requirements are not effective until they have been approved by the OMB.
To obtain copies of the supporting statement and any related forms for the 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-5522-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 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
This final rule with comment period is necessary to make statutorily required policy changes and other policy updates to the Merit-based Incentive Payment System (MIPS) established under MACRA as well as the policies related to the Advanced APM provisions of MACRA, which together are referred to as the Quality Payment Program. As required by MACRA, MIPS consolidates several quality programs, including components of the Medicare Electronic Health Record Incentive Program, the Physician Quality Reporting System (PQRS), and the Physician Value-Based Payment Modifier (VM) and Physician Feedback Program. MACRA effectively ends these programs after CY 2018 and authorizes MIPS' operation beginning with payments under Part B for items and services furnished in CY 2019.
The Quality Payment Program is structured to improve care quality over time with input from clinicians, patients, and other stakeholders. We have sought and continue to seek feedback from the health care community through various public avenues such as listening sessions, request for information and rulemaking where we have received feedback that many clinical practices are still working towards implementing the Quality Payment Program. This final rule with comment period for Quality Payment Program Year 2 reflects this feedback and includes several policies that extend transition year policies finalized in the CY 2017 Quality Payment Program final rule with comment period; however, we also include policies to begin ramping up to full implementation, since the MIPS performance threshold must be the mean or median of the final scores for all MIPS eligible clinicians for a prior period starting in the 2019 MIPS performance period (2021 MIPS payment year). Additionally, we noted in the proposed rule that we address elements of MACRA that were not included in the first year of the program, including virtual groups, facility-based measurement, and improvement scoring (82 FR 30010). We also include policies to continue implementing elements of MACRA that do not take effect in the first or second year of the Quality Payment Program, including policies related to the All-Payer Combination Option for the APM incentive.
We have examined the impact of this final rule with comment period 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 (Pub. L. 96-354 enacted September 19, 1980) (RFA), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 14-04 enacted March 22, 1995), Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). We estimate, as discussed below in this section, that the Medicare Part B provisions included in this final rule with comment period will redistribute more than $118 million in budget neutral payments in the second performance year. In addition, as specified by Section 101 of the MACRA this final rule with comment period will increase government outlays for the exceptional performance payment adjustments under MIPS ($500 million), and incentive payments to QPs (approximately $675 to $900 million). Overall, this rule will transfer more than $1 billion in payment adjustments for MIPS eligible clinicians and incentive payments to QPs. 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.
Executive Order 13771, titled Reducing Regulation and Controlling Regulatory Costs, was issued on January 30, 2017. This final rule is considered an EO 13771 deregulatory action. As shown in the discussion of Table 84 in the Collection of Information section of this final rule with comment period, we estimate that this final rule with
The RFA requires agencies to prepare an Initial Regulatory Flexibility Analysis to describe and analyze the impact of the final rule on small entities unless the Secretary can certify that the regulation will not have a significant impact on a substantial number of small entities. The RFA requires agencies to analyze options for regulatory relief of small entities. Note that Small Business Administration (SBA) standards for small entities differ than the definition of a small practice under MIPS finalized in the CY 2017 Quality Payment Program final rule under § 414.1305. The SBA standard for a small business is $11 million in average receipts for an office of clinicians and $7.5 million in average annual receipts for an office of other health practitioners. (For details, see the SBA's Web site at
Approximately 95 percent of practitioners, other providers, and suppliers are considered to be small entities either by nonprofit status or by having annual revenues that qualify for small business status under the SBA standards. There are over 1 million physicians, other practitioners, and medical suppliers that receive Medicare payment under the PFS. Because many of the affected entities are small entities, the analysis and discussion provided in this RIA section as well as elsewhere in this final rule with comment period is intended to comply with the requirement for a Final Regulatory Flexibility Analysis (FRFA).
As discussed below, approximately 622,000 MIPS eligible clinicians will be required to submit data under MIPS. This represents just over 50 percent of clinicians who meet the statutory requirements of being eligible clinician and not being newly enrolled (approximately 622,000 out of 1.2 million who are eligible and not newly enrolled.) As shown later in this analysis, however, potential reductions in Medicare Part B payment for MIPS eligible clinicians under the MIPS are a certain percentage of their total Medicare Part B paid charges—5 percent in the 2020 MIPS payment year—though rising to as high as 9 percent in subsequent years. On average, clinicians' Medicare billings are only approximately 23 percent of their total revenue,
For the 2018 MIPS performance period, this final rule with comment period has several key policies that will provide regulatory relief for clinicians and practices and help increase ways for successful participation. These include implementing virtual groups, raising the low volume threshold, continuing to allow the use of 2014 Edition CEHRT, and adding a new significant hardship exception for the advancing care information performance category for MIPS eligible clinicians who are in small practices, as summarized in section I.D.4 of this final rule with comment period.
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 hospitals located in rural areas. 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 hospital located in a rural area 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 hospitals located in rural areas.
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 2017, that threshold is approximately $148 million. This final rule with comment period imposes 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
Executive Order 13132 establishes certain requirements that an agency must meet when it issues a proposed rule (and subsequent final rule) that imposes substantial direct effects on state and local governments, preempts state law, or otherwise has Federalism implications. We have outlined in section II.D.6.b. of this final rule with comment period a payer-initiated identification process for identifying which payment arrangements qualify as Other Payer Advanced APMs. State Medicaid programs may elect to participate in the payer-initiated identification process. Beginning in Quality Payment Program Year 3, the All-Payer Combination Option will be an available pathway to QP status for eligible clinicians participating sufficiently in Advanced APMs and Other Payer Advanced APMs. The All-Payer Combination Option allows for eligible clinicians to achieve QP status through their participation in both Advanced APMs and Other Payer Advanced APMs. To include an eligible clinician's participation in Other Payer Advanced APMs in their QP threshold score, we will need to determine if certain payment arrangements with other payers meet the criteria to be Other Payer Advanced APMs (Medicaid Specific Eligible Clinician Initiated Process (§ 414.1445)). We do not believe any of these policies impose a substantial direct effect on the Medicaid program as participation in the Payer Initiated Determination Process is voluntary and use of the Eligible Clinician Initiated Determination Process is also voluntary.
We note that we are also adopting policies in an interim final rule with comment period that address extreme and uncontrollable circumstances MIPS eligible clinicians may face as a result of widespread catastrophic events affecting a region or locale in CY 2017, such as Hurricanes Irma, Harvey and Maria. 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 note that many of the MIPS policies from the CY 2017 Quality Payment Program final rule were only defined for the 2017 MIPS performance period and 2019 MIPS payment year (including the performance threshold, the performance category reweighting policies, and many scoring policies for the quality performance category) which precludes us from developing a baseline for the 2018 MIPS performance period and 2020 MIPS payment year if there were no new regulatory action. 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 MACRA, (1) repeals the Sustainable Growth Rate (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's Medicare Part B payments for items and services (which includes services under the Physician Fee Schedule, Part B drugs and other Part B payments) for a year.
The largest component of MACRA costs is its replacement of scheduled reductions in physician payments with payment rates first frozen at 2015 levels and then increasing at a rate of 0.5 percent a year during CYs 2016 through 2019. The estimates in this RIA take those legislated rates as the baseline for the estimates we make as to the costs, benefits, and transfer effects of this final regulation, with some data submission provisions for the 2018 MIPS performance period taking effect in 2018 and 2019, and the corresponding positive and negative payment adjustments taking effect in the 2020 MIPS payment year.
As required by 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 clinician achieves the threshold for participation in Advanced APMs to be considered a QP or Partial QP, or is instead evaluated under MIPS.
From 2019 through 2024, eligible clinicians receiving a sufficient portion of Medicare Part B payments for covered professional services or seeing a sufficient number of Medicare patients through Advanced APMs as required 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, as discussed in section II.D.5. of this final rule with comment period.
The APM Incentive Payment is separate from, and in addition to, the payment for covered professional services furnished by an eligible clinician during that year. Eligible clinicians who become QPs for a year would not need to report to MIPS and would not receive a MIPS payment adjustment to their Part B payments. Eligible clinicians who do not become QPs, but meet a slightly lower threshold to become Partial QPs for the year, may elect to report to MIPS and would then be scored under MIPS and receive a MIPS payment adjustment, but do not receive the APM Incentive Payment. For the 2018 Medicare 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 Advanced APM Entity, or furnish Part B covered professional services to at least 10 percent, but less than 20 percent, of their Medicare beneficiaries through an Advanced APM Entity. If the Partial QP elects to be scored under MIPS, they would be subject to all MIPS requirements and would receive a MIPS payment adjustment. This adjustment may be positive or negative. If an eligible clinician does not meet either the QP or Partial QP standards, the eligible clinician would be subject to MIPS, would report to MIPS, and would receive the corresponding MIPS payment adjustment.
Beginning in 2026, payment rates for services furnished by clinicians who achieve QP status for a year would be increased each year by 0.75 percent for the year, while payment rates for services furnished by clinicians who do not achieve QP status for the year would be increased by 0.25 percent. In addition, MIPS eligible clinicians would
We estimate that between 185,000 and 250,000 eligible clinicians will become QPs, therefore be exempt from MIPS, and qualify for lump sum incentive payment based on 5 percent of their Part B allowable charges for covered professional services, which are estimated to be between approximately $13,500 million and $18,000 million in the 2018 Quality Payment Program performance year. We estimate that the aggregate total of the APM incentive payment of 5 percent of Part B allowed charges for QPs would be between approximately $675 and $900 million for the 2020 Quality Payment Program payment year. These estimates reflect longstanding HHS policy not to attempt to predict the effects of future rulemaking in order to maximize future Secretarial discretion over whether, and if so how, payment or other rules would be changed.
We project the number of eligible clinicians that will be excluded from MIPS as 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 that will be operating in 2018. This final rule with comment period indicates which APMs would be Advanced APMs under the finalized policies, including the Next Generation ACO Model, Comprehensive Primary Care Plus (CPC+) Model, Comprehensive ESRD Care (CEC) Model (Two-Sided Risk Arrangement), Vermont All-Payer ACO Model,
Certain clinicians may not be eligible to participate or may be excluded from participation in MIPS for various reasons. For example, MACRA requires us to limit eligibility for the 2019 and 2020 MIPS payment years to specified clinician types. Additionally, we exclude eligible clinicians with billings that do not exceed the low volume threshold as finalized in section II.C.2.c. of this final rule with comment period: Those with $90,000 or less in Part B allowed charges or 200 or fewer Medicare Part B patients as measured at the TIN/NPI level for individual reporting, the TIN level for group reporting, 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.
To estimate the number of clinicians that are not in MIPS due to an ineligible clinician type for CY 2018, our scoring model used the first 2019 Payment Year MIPS eligibility file as described in 81 FR 77069 through 77070. The data file included 1.5 million clinicians who had Medicare Part B claims from September 1, 2015 to August 31, 2016 and included a 60-day claim run-out. We limited our analysis to those clinicians identified as MIPS eligible clinician types for the 2020 MIPS payment year: Doctors of medicine, doctors of osteopathy, chiropractors, dentists, optometrists, podiatrists, nurse practitioners, physician assistants, certified registered nurse anesthetists, and clinical nurse specialists.
We estimated the number of clinicians excluded for low volume by comparing the allowed Medicare Part B charges in the first 2019 MIPS payment year eligibility file to the finalized low volume threshold. We used 2016 PQRS reporting data to determine whether clinicians have historically reported as a group and whether to make the low-volume determination at the individual (TIN/NPI) or group (TIN) level. We assumed all 2016 ACO participants (including participants from Shared Savings Program or Pioneer or Next Generation ACO Models) would exceed the low volume threshold because the ACOs are required to have a minimum number of assigned beneficiaries.
Because of the lack of available data on which eligible clinicians would elect to participate as part of a virtual group under the policies finalized in section II.C.4. of this final rule with comment period, the scoring model does not reflect the finalized policies for scoring virtual groups.
We estimated the number of newly enrolled Medicare clinicians to be excluded from MIPS by assuming clinicians (NPIs) are newly enrolled if they have Part B charges in the eligibility file, but no Part B charges in 2015. Because of data limitations, this newly enrolled modeling methodology is different than the one that will be used under the policies finalized under §§ 414.1310 and 414.1315.
To exclude QPs from our scoring model and because the performance year 2018 summary was not available at the TIN/NPI level, we used the 2017 initial QP determination file. We assumed that all partial QPs would participate in MIPS and included them in our scoring model. Because of the expected growth in Advanced APM participation, the estimated number of QPs excluded from our model (an additional 70,732 clinicians after all other MIPS exclusions have been applied) based on data from the 2017 Quality Payment Program performance period is lower than the summary level projection for the 2018 Quality Payment Program performance period based on the expected growth in APM participation (to a total of 185,000-250,000). The 185,000 to 250,000 eligible clinicians represent the projected range of QPs for the performance year 2018. This expected growth is due in part to the entry of new participants in CPC+ and the Next Generation ACO Model for 2018, and the Medicare ACO Track 1+ Model which is projected to have a large number of participants, with a large majority reaching QP status. Hence, our model may overestimate the fraction of clinicians and allowed Medicare Part B charges that will remain subject to MIPS after the exclusions.
We have estimated the cumulative effects of these exclusions in Table 75.
Table 75 also shows the number of eligible clinicians remaining in the scoring model used for this RIA (604,006) is lower than the estimated number of eligible clinicians remaining after exclusions (621,700). The discrepancy is due to our scoring model excluding clinicians that submitted via measures groups under the 2016 PQRS, since that data submission mechanism was eliminated under MIPS.
Our scoring model includes eligible clinicians who will be required to submit MIPS data to us in the 2017 MIPS performance period.
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 Medicare revenues for services under other Medicare payment systems, such as the Medicare Federally Qualified Health Center Prospective Payment System or Medicare Advantage, that would not be affected by MIPS payment adjustment factors.
To estimate the impact of MIPS on clinicians required to report, we used the most recently available data, including 2015 and 2016 PQRS data, 2014 and 2015 CAHPS for PQRS data, 2014 and 2015 VM data, 2015 and 2016 Medicare and Medicaid EHR Incentive Program data, the data prepared to support the 2017 performance period initial determination of clinician and special status eligibility (available via the NPI lookup on
We estimated the quality performance category score using measures submitted to PQRS for the 2016 performance period. For quality measures submitted via the claims, EHR, qualified registry, QCDR, and CMS-approved survey vendor submission mechanisms, we applied the published benchmarks developed for the 2017 MIPS performance period. For quality measures submitted via Web Interface, we applied the published benchmarks developed for the 2016/2017 reporting years for the Shared Savings Program where available, and did not calculate scores for measures for which Shared Savings Program benchmarks did not exist. As mentioned in II.C.6.a.(1) of this final rule with comment period, we are finalizing the multiple submission mechanism policy beginning with year 3 to allow additional time to communicate how this policy intersects with our measure applicability policies. Also, given
Because we are not finalizing our proposal to allow multiple submission mechanisms within a performance category for the CY 2018 performance period, we scored the quality performance category score based on the measures within each submission mechanism and selected the submission mechanism with the highest score. In order to estimate the impact of improvement for the quality performance category, we estimated a quality performance category percent score using 2015 PQRS data, 2014 CAHPS for PQRS data, and 2014 VM data. Because we lack detailed information on which MIPS eligible clinicians would elect to submit as part of a virtual group, the finalized policy regarding virtual groups is not reflected in our scoring model. Our model applied the MIPS APM scoring standards in section II.C.6.g. of this final rule with comment period to quality data from MIPS eligible clinicians that participated in the Shared Savings Program, the Pioneer ACO model, and the Next Generation ACO model in 2016.
We estimated the cost performance category score using measures computed for the 2017 value modifier (VM) using data for calendar year 2015. We used the total per capita cost measure and the Medicare Spending Per Beneficiary (MSPB) measure. These VM measures are computed for the TIN, so each MIPS eligible clinician was assigned the cost performance category score for the applicable TIN. We developed benchmarks based on the VM data and assigned between 1 and 10 points per measure if the case minimum was met. We required a minimum of 20 eligible cases for using the total cost per capita score, and a minimum of 35 eligible cases for using the Medicare spending per beneficiary score. Due to limited data, we did not estimate an improvement score for the cost performance category. When the minimum case requirement was met for one of these two measures but not the other, we estimated the cost performance category score a as the value of the measure that had the required number of cases. When the minimum case requirement was not met for either measure then we did not estimate a score for the cost performance category, and the weight for the cost performance category was reassigned to the quality performance quality.
For the advancing care information performance category score, we used data from the CY 2015 and 2016 Medicare and Medicaid EHR Incentive Programs. Because the EHR Incentive Programs are based on attestation at the NPI level, the advancing care information performance category scores are assigned to clinicians by their individual NPI, regardless of whether the clinician was part of a group submission for PQRS. We assigned a score of 100 percent to MIPS eligible clinicians who attested in the 2015 Medicare EHR Incentive Program or received a 2015 incentive payment from the Medicaid EHR Incentive Program (after excluding incentive payments to adopt, implement, and upgrade). While we had attestation information for the Medicare EHR Incentive Program, we did not have detailed attestation information for the Medicaid EHR Incentive Program. Therefore, we used incentive payments (excluding the adopt implement and upgrade incentive payments) as a proxy for attestation in the Medicaid EHR Incentive Program. Our rationale for selecting a 100 percent performance score is that the requirements to achieve a base score of 50 percent in MIPS are lower than the EHR Incentive Program requirements to attest for meaningful use (which determined whether program requirements were met on an all or nothing basis). We anticipate clinicians who met EHR Incentive Program requirements for meaningful use will be able to achieve an advancing care information performance category score of 100 percent. Because the minimum requirements for meaningful use did not allow partial scoring, we believe the clinicians who met the minimum requirements would be able to achieve an advancing care information performance category score of 100 percent. For example, the minimum requirements to attest to Modified Stage 2 objectives and measures for the 2017 Medicare EHR Incentive Program (assuming no measure exceptions and an immunization registry is available) would translate into an advancing care information performance category score of 85 percent. Generally, we see that clinicians have performance greater than the minimum requirements, which is the reason we estimated an advancing care information performance category score of 100 percent.
For those clinicians who did not attest in either the 2015 Medicare or Medicaid EHR Incentive Program, we evaluated whether the MIPS eligible clinician could have their advancing care information performance category score reweighted. The advancing care information performance category weight is set equal to zero percent, and the weight is redistributed to the quality performance category for non-patient facing clinicians, hospital-based clinicians, ASC-based clinicians, NPs, PAs, CRNAs, or CNSs, or those who request and are approved for a significant hardship or other type of exception, including a new significant hardship exception for small practices, or clinicians who are granted an exception based on decertified EHR technology. We used the non-patient facing and hospital-based indicators and specialty and small practice indicators as calculated in the initial MIPS eligibility run. Due to data limitations, we were not able to reweight the advancing care information performance category scores of ASC-based clinicians in our scoring model. For significant hardship exceptions, we used the 2016 final approved significant hardship file from the Medicare EHR Incentive Program. If a MIPS eligible clinician did not attest and did not qualify for a reweighting of their advancing care information performance category, the advancing care information performance category score was set equal to zero percent. We modeled the improvement activities performance category score based on 2016 APM participation and historic participation in 2016 PQRS and 2016 Medicare and Medicaid EHR Incentive Programs. Our model identified 2016 participants in the Shared Savings Program, Next Generation ACO Model and the Pioneer ACO Model, and assigned them an improvement activity score of 100
Clinicians and groups not participating in a MIPS APM were assigned an improvement activities score based on their performance in the quality and advancing care information performance categories. MIPS eligible clinicians whose 2016 PQRS data meets all the MIPS quality submission criteria (for example, submitting 6 measures with data completeness, including one outcome or high priority measures) and had an estimated advancing care information performance category score of 100 percent (if advancing care information is applicable to them) are assigned an improvement activities performance category score of 100 percent. MIPS eligible clinicians who did not participate in 2016 PQRS or the 2015 Medicare or Medicaid EHR Incentive Program (if it was applicable), earned an improvement activity performance category score of zero percent, with the rationale that these clinicians may be less likely to participate in MIPS if they have not previously participated in other programs.
For the remaining MIPS eligible clinicians not assigned an improvement activities performance category score of 0 or 100 percent in our model, we assigned a score that corresponds to submitting one medium-weighted improvement activity. The MIPS eligible clinicians assigned an improvement activity performance category score corresponding to a medium-weighted activity include (a) those who submitted some quality measures under the 2016 PQRS but did not meet the MIPS quality submission criteria or (b) those who did not submit any quality data under the 2016 PQRS who attested under the Medicare EHR Incentive program or received an incentive payment (excluding adopt implement and upgrade payments) from the Medicaid EHR Incentive Program. We assumed that these clinicians may be likely to partially, but not fully participate, in the improvement activities category. For non-patient facing clinicians, clinicians in a small practice (consisting of 15 or fewer professionals), clinicians in practices located in a rural area, clinicians in a geographic healthcare professional shortage area (HPSA) practice or any combination thereof, the medium weighted improvement activity was assigned one-half of the total possible improvement activities performance category score (20 out of a 40 possible points or 50 percent). The remaining MIPS eligible clinicians not assigned an improvement activities performance category score of 0, 50, or 100 percentage points were assigned a score corresponding to one medium-weighted activity (10 out of 40 possible points or 25 percent). Due to lack of available data, we were not able to identify MIPS eligible clinicians in patient-centered medical homes or comparable specialty societies in our scoring model. The policy finalized under § 414.1380(b)(3) states that 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. In other words, MIPS eligible clinicians in a patient centered medical home or comparable specialty societies would qualify for an improvement activities performance category score of 100 percent.
Our model assigns a final score for each TIN/NPI by multiplying each performance category score by the corresponding performance category weight, adding the products together, and multiplying the sum by 100 points. For MIPS eligible clinicians that had their advancing care information performance category score reweighted due to a significant hardship exception or automatic reweighting, the weight for the advancing care information performance category was assigned to the quality performance category. For MIPS eligible clinicians whose TIN did not have a cost performance category score assigned the weight for the cost performance category was assigned to the quality performance category.
The scoring model reflects the finalized bonuses for complex patients and small practices in sections II.C.7.b.(1)(b) and II.C.7.b.(1)(c) of this final rule with comment period. Consistent with the policy to define complex patients as those with high medical risk or with dual eligibility, our scoring model calculated the bonus by using average Hierarchical Condition Category (HCC) risk score, as well as the MIPS eligible clinician's patients dual eligible proportion calculated for each NPI in the 2015 Physician and Other Supplier Public Use File. The dual eligible proportion for each MIPS eligible clinician was multiplied by 5. We also generated a group average HCC risk score by weighing the scores for individual clinicians in each group by the number of beneficiaries they have seen. We generated group dual eligible proportions using the weighted average dual eligible patient ratio for all MIPS eligible clinicians in the groups, which was then multiplied by 5. The complex patient bonus was calculated by adding together the average HCC risk score and the ratio of dual eligible patients multiplied by 5, with a 5 point cap. Our scoring model also adds 5 points to the final score for small practices that had a final score greater than 0 points. After adding any applicable bonus for complex patients and small practices, we set any final scores that exceeded 100 points to equal 100 points.
We then implemented an exchange function based on the provisions of this final rule with comment period to estimate the positive or negative MIPS payment adjustment based on the estimated final score and the Medicare Part B paid charges. We calculated the parameters of the exchange function distributions of MIPS payment adjustments that meet statutory requirements related to the linear sliding scale, budget neutrality and aggregate exceptional performance payment adjustment amounts (as finalized under § 414.1405). Our model used a 15-point performance threshold and a 70-point additional performance threshold.
With the extensive changes to policy and the flexibility that is allowed under MIPS, estimating impacts of this final rule with comment period using only historic 2016 PQRS participation assumptions would significantly overestimate the impact on clinicians, particularly on clinicians in practices with 1 to 15 clinicians, which have traditionally had lower participation rates. 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 a minimum 90 percent of MIPS eligible clinicians will participate in submitting quality performance category data to MIPS, regardless of practice size. Therefore, we assumed that, on average, the categories of practices with 1 to 15 clinicians would have 90 percent participation in the quality performance category. This assumption is an increase from existing historical data. PQRS participation rates have increased steadily since the program began; the 2015 PQRS Experience Report showed an increase in the participation rate from 15 percent in 2007 to 69 percent
To simulate the impact of the standard model assumption, we randomly select a subset of non-participants. For each of these non-participants we substitute the quality score of a randomly selected participant, and recompute the improvement activity score to reflect the change in quality participation status. For example, for a previously non-participating clinician, we substitute the scores of a randomly selected MIPS eligible clinician with a quality score of 73 percent. The improvement activities performance category score is then computed using this randomly selected clinician's quality participation status. We did not apply the same participation assumptions to the advancing care information performance category because the category applies only to a subset of MIPS eligible clinicians, and, as noted above, would be weighted at zero percent for non-patient facing clinicians, hospital-based clinicians, ASC-based clinicians, NPs, PAs, CRNAs, or CNSs, and those who request and are approved for a significant hardship or other type of exception, including those in small practices. Further, we took into account that advancing care information performance category participation may be affected by the cost and time it may take to acquire and implement certified EHR technology needed to perform in that performance category. We did not apply the same participation assumptions to the cost performance category because the category uses claims data, so participation does not require any special action by MIPS eligible clinicians.
The second analysis, which we label as “alternative participation assumptions,” assumes a minimum participation rate in the quality performance category of 80 percent. In the CY 2018 QPP proposed rule [82 FR 30237], we used 2015 PQRS data and in this final rule with comment period we updated it with 2016 PQRS data. Because both the 2015 and 2016 PQRS participation rates for practices of more than 15 clinicians are greater than 80 percent, this analysis assumes increased participation for practices of 1 to 15 clinicians only. Practices of more than 15 clinicians are included in the model at their historic participation rates.
Table 76 summarizes the impact on Part B paid amount (physician fee schedule services, certain Part B drugs, and other non-physician fee schedule services) of MIPS eligible clinicians by specialty for the standard participation assumptions.
Table 77 summarizes the impact on Part B paid amount (physician fee schedule services, certain Part B drugs, and other non-physician fee schedule services) of MIPS eligible clinicians by specialty under the alternative participation assumptions.
Tables 78 and 79 summarize the impact on Part B paid amount (physician fee schedule services, certain Part B drugs, and other non-physician fee schedule services) of MIPS eligible clinicians by practice size for the standard participation assumptions (Table 78) and the alternative participation assumptions (Table 79).
Tables 76 and 78 show that under our standard participation assumptions, the vast majority (97.1 percent) of MIPS eligible clinicians are anticipated to receive positive or neutral MIPS payment adjustments for the 2020 MIPS payment year, with only 2.9 percent receiving negative MIPS payment adjustments. Using the alternative participation assumptions, Tables 77 and 79 shows that 95.3 percent of MIPS eligible clinicians are expected to receive positive or neutral payment adjustments.
The projected distribution of funds reflects this final rule with comment period's emphasis on increasing more complete reporting of MIPS eligible clinicians for the Quality Payment Program Year 2, which continues the ramp to more robust participation in future MIPS performance years.
We chose not to finalize the proposals in the CY 2018 Quality Payment Program proposed rule to allow beginning with the 2019 MIPS performance period: Implementing facility based measurement (82 FR 30125) and allowing MIPS eligible clinicians to submit data via multiple submission mechanisms (82 FR 30035 through 30036).
The following policy changes were made between the proposed and final rule with comment period that affected our model: The cost performance category is weighted at 10 percent not zero percent; the multiple submission mechanism policy was not finalized for the 2018 MIPS performance period; we increased the topped out scoring cap from 6 points to 7 points and the quality data completeness threshold for claims, EHR, QCDR and registry submission mechanisms increased from 50 percent to 60 percent; and we modified the complex patient bonus by increasing the bonus to 5 points and including both HCC risk and dual eligible ratio in the bonus. In addition to the policy changes, we updated the PQRS information for 2016 which affected the quality score and the number of clinicians we estimated participated in group reporting and the file used to estimate QP.
We believe that most MIPS eligible clinicians who can report the advancing care information performance category of MIPS have already adopted an EHR during Stage 1 and 2 of the Medicare or Medicaid EHR Incentive Programs, and will have limited additional operational expenses related to compliance with the advancing care information performance category requirements. Under the policies established in the CY 2017 Quality Payment Program final rule, MIPS eligible clinicians who did not participate in the Medicare and Medicaid EHR Incentive Programs could potentially have faced additional operational expenses for implementation and compliance with the advancing care information performance category requirements. We believe that clinicians who complied with the transition year requirements of the advancing care information performance category will incur no additional costs for compliance for this final rule with comment period. This final rule with comment period allows clinicians to continue to use EHR technology certified to the 2014 Edition CEHRT, which would allow them to use the same technology required in the transition year. (Clinicians may also choose to use the 2015 Edition CEHRT or a combination of the two.) Similarly, we believe that third parties who submit data on behalf of clinicians who prepared to submit data in the transition year will not incur additional costs as a result of this rule.
As a result of this final rule with comment period, some clinicians who were required to submit advancing care information performance category data under transition year policies will no longer be required to submit data.. As described in section II.C.2.c of this final rule with comment period, we found that increasing the low-volume threshold to exclude individual eligible clinicians or groups that have Medicare Part B allowed charges less than or equal to $90,000 or that provide care for 200 or fewer Part B-enrolled Medicare beneficiaries will exclude approximately 123,000 additional clinicians from MIPS from the approximately 744,000 clinicians that would have been eligible based on the low-volume threshold that was finalized in the CY 2017 Quality Payment Program final rule. Among the 123,000 additional clinicians excluded due to the increase in the low-volume threshold, we estimate that approximately 40,000 clinicians who had not previously participate in the EHR Incentive Program would have been required to submit advancing care information performance category data under the low-volume threshold finalized in the CY 2017 Quality Payment Program final rule.
In addition to changes to the low volume threshold, we have expanded the reasons a clinician can qualify for having the advancing care information category be weighted at zero percent of the final score. We will continue our policy that was finalized in the 2017 Quality Payment Program final rule at § 414.1375(a) to reweight the advancing care information performance category scores for certain MIPS eligible clinicians, including those who may have been exempt from the Medicare EHR Incentive Program such as hospital-based clinicians, non-patient facing clinicians, PAs, NPs, CNs and CRNAs (81 FR 77237 through 77245). Further, as described in section II.6.f.(7)(a)(iv) of this final rule with comment period, we rely on section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act, to assign a scoring weight of zero percent for the advancing care information performance category for MIPS eligible clinicians who are determined to be based in ambulatory surgical centers (ASCs). As described in section II.6.f.(7)(a)(i) of this final rule with comment period, we rely on section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) of the 21st Century Cures Act, to allow MIPS eligible clinicians to apply for a significant hardship exception and subsequently have their advancing care information performance category reweighted to zero when they are faced with a significant hardship. Relying on this same authority, we are finalizing a new significant hardship exception for the advancing care information performance category for MIPS eligible clinicians who are in small practices, as discussed in section II.6.f.7.(a)(ii) of this final rule with comment period, and finalizing an exception for MIPS eligible clinicians whose CEHRT has been decertified under ONC's Health IT Certification Program as discussed in section II.6.f.7.(a)(v) of this final rule with comment period. While we are unable to account for all of these exceptions in our model, we do estimate that approximately 60,000 MIPS eligible clinicians in small practices who had not previously reported under the EHR Incentive Program would not have to adopt an EHR to comply with the advancing care information performance category requirements.
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. However, given that approximately 40,000 clinicians would no longer be eligible due to the low-volume threshold and approximately 60,000 MIPS eligible clinicians in small practices qualify for a significant hardship exception, we believe the overall cost of compliance would decrease as a result of this final rule with comment period.
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 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: Metric 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
We requested comments that provide information that would enable us to quantify the costs, costs savings, and benefits associated with implementation and compliance with the requirements of the advancing care information performance category.
The following is a summary of the public comments received regarding information that would enable us to quantify the costs, costs savings, and benefits associated with implementation and compliance with the requirements of the advancing care information performance category and our responses:
Under the policies established in the CY 2017 Quality Payment Program final rule, the costs for complying with the improvement activities performance category requirements could have potentially led 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 (patient) member per month.
Costs for compliance with transition year policies may vary based on panel size (number of patients assigned to each care team) and location of practice among other variables. For example, Magill (2015) conducted a study of certified patient-centered medical home practices in two states.
The following factors also contribute to the difficulty of identifying compliance costs for the improvement activities performance category. Some improvement activities, such as those related to expanded hours and access (for example, IA_EPA_1 “Provide 24/7 Access to Eligible Clinicians or Groups Who Have Real-time Access to Patient's Medical Record” as finalized in Table G of the appendices of this final rule with comment period), may be revenue neutral as MIPS eligible clinicians can receive payment for services provided during the expanded hours. Other improvement activities, such as IA_PSPA_2 “Participation in MOC Part IV” (as finalized in Table G of the appendices of this final rule with comment period), is connected to board certification, and we anticipate that there would be no additional compliance costs associated with this final rule with comment period above and beyond costs that clinicians already incur to maintain board certification. Some improvement activities have direct out-of-pocket costs, such as fees, while other improvement activities have no fees.
While we are unable to quantify the compliance costs of the improvement activities performance category, we do believe that because we are increasing the low volume threshold (as described in section II.C.2.c of this final rule with comment period), we will exclude approximately 123,000 additional clinicians from MIPS from the approximately 744,000 clinicians that would have been eligible based on the low-volume threshold that was finalized in the CY 2017 Quality Payment Program final rule. With this reduction in clinicians that are required to submit data to the improvement activities performance category, we believe the overall potential cost of compliance would decrease as a result of this final rule with comment period.
Further, we anticipate that the vast majority of clinicians submitting improvement activities data to comply with transition year policies could continue to submit the same activities under the policies established in this final year with comment period. Only 1 of the 92 improvement activities established in the transition year was removed from the inventory, while 20 additional activities were added (See
The following is a summary of the public comments received and our responses:
There were a number of changes in this final rule with comment period that will have an effect on beneficiaries. In general, we believe that the changes may have a positive impact and improve the quality and value of care provided to Medicare beneficiaries. More broadly, we expect that over time clinician engagement in the Quality Payment Program may result in improved quality of patient care, resulting in lower morbidity and mortality. We believe the policies finalized in the CY 2017 Quality Payment Program final rule, as well as policies in this rule will lead to additional growth in the participation of both MIPS APMS and Advanced APMs. APMs promote seamless integration by way of their payment methodology and design that incentivize such care coordination. The policies that are being finalized regarding the All-Payer Combination Option and identification of Other Payer Advanced APMs will help facilitate both the development and participation in alternative payment arrangements in the private and public sectors. Beginning in Quality Payment Program Year 3, the All-Payer Combination Option will be an available pathway to QP status for eligible clinicians participating sufficiently in Advanced APMs and Other Payer Advanced APMs. The All-Payer Combination Option allows for eligible clinicians to achieve QP status through their participation in both Advanced APMs and Other Payer Advanced APMs. Clinicians can focus their efforts around the care transformation in either Advanced APM or MIPS APM models and know that those efforts will be aligned with the Quality Payment Program, either through incentive payments for QPs or through MIPS scores calculated based on performance within the APM assessed at the APM Entity level.
Several Advanced APMs and MIPS APMS have shown evidence of improving the quality of care provided to beneficiaries and beneficiaries' experience of care. For example, in August of 2015, we issued quality and financial performance results for 2014 showing that ACOs continue to improve the quality of care for Medicare beneficiaries while generating net savings to the Medicare trust fund, if shared savings paid out to these ACOs are not included.
The results from the third program year (January through December 2015) of the original CPC Initiative indicate that from 2013 to 2015 CPC practices transformed their care delivery—with the biggest improvements in risk-stratified care management, expanded access to care, and continuity of care. The independent evaluation also found
As the early findings from the original CPC initiative and literature from other medical home models supported by payment suggest, we expect to see improvement in quality and patient experience of care.
While maintaining coverage of Original Medicare services and beneficiary freedom to choose providers, ACOs could potentially enhance care management of the chronically ill aligned population through the adoption of leading-edge technologies, care coordination techniques, and evidence-based benefit enhancements that motivate providers and beneficiaries to optimize care. The evidence discussed here focuses on the benefit enhancements available under the Next Generation ACO Model, which include enhanced telehealth and home health care.
The transition from the inpatient setting to home is a critical period for patients, particularly elderly populations. Studies have examined a variety of interventions to help smooth care transitions. Interventions found in the literature include advance practice nurse-led comprehensive discharge planning and home visit follow-up protocols
The study of the potential value and efficacy of telehealth and remote patient monitoring has become more prevalent in recent years as technology has enabled greater utilization of these services.
We estimate that the Quality Payment Program Year 2 will not have a significant economic effect on eligible clinicians and groups and believe that MIPS policies, along with increasing participation in APMs over time may succeed in improving quality and reducing costs. This may in turn result in beneficial effects on both patients and some clinicians, and we intend to continue focusing on clinician-driven, patient-centered care.
We will implement several policies for the Quality Payment Program Year 2 to reduce burden. These include raising the low-volume threshold with the effect that fewer clinicians in small practices are required to participate in the MIPS starting with the 2018 MIPS performance period; including bonus points for clinicians in small practices; adding a new significant hardship exception for the advancing care information performance category for MIPS eligible clinicians in small practices; implementing virtual groups; and extending the ability of MIPS eligible clinicians and groups to use 2014 CEHRT Edition while providing bonus points for the use of the 2015 Edition of CEHRT. Additionally, for vendors, we believe the flexibility to use EHR technology certified to either the 2014 Edition or the 2015 Edition for the Quality Payment Program Year 2 is beneficial as vendors will have additional time to deploy the updated software to their customers, which are the clinicians and other providers. Clinicians will likewise have additional time to upgrade and implement the new functionalities.
In summary, the Quality Payment Program policies are designed to promote the delivery of high-value care for individuals in all practices and areas with a focus on easing the burden for clinicians in small and solo practices. We believe each of these policies will further reduce burdens on clinicians and practices and help increase successful participation. Further, the policies throughout this final rule with comment period will focus the Quality Payment Program in its second year on encouraging more complete data submission and educating clinicians. The policies will continue a glide path, which began in the transition year, to more robust participation and performance in future years. The policy
This final rule with comment period contains a range of policies, including many 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 policies and, where relevant, analyzes alternatives that we considered. We view the performance threshold as one of the most important factors affecting the distribution of payment adjustments under the Quality Payment Program, and the alternatives that we considered focus on that policy.
For example, as discussed in section II.C.8.c. of this final rule with comment period, we finalized a 15-point performance threshold and a 70-point additional performance threshold. As described earlier, we assumed a minimum 90 percent participation rate in each category of eligible clinicians and an alternative with a minimum 80 percent participation rate. We displayed the results of that modeling in Table 76 and 77 along with subsequent tables described in section VI.B.2 of this final rule with comment period.
In addition, as discussed in section II.C.2.c, we increased the low-volume threshold to exclude individual eligible clinicians or groups that have Medicare Part B allowed charges less than or equal to $90,000 or that provide care for 200 or fewer Part B-enrolled Medicare beneficiaries compared to the low-volume threshold that was finalized in the CY 2017 Quality Payment Program final rule which would exclude individual eligible clinicians or groups that have Medicare Part B allowed charges less than or equal to $30,000 or that provide care for 100 or fewer Part B-enrolled Medicare beneficiaries. Using our standard model assumptions described in section VI.C.3 of this final rule with comment period, the low volume threshold based on the transition year would have included approximately 744,000 MIPS eligible clinicians distribute approximately $139 million in payment adjustments on a budget-neutral basis, compared to our final policy which has 622,000 MIPS eligible clinicians and distributes approximately $118 million in payment adjustments on a budget-neutral basis.
We would like to note several limitations to the analyses that estimated MIPS eligible clinicians' eligibility, negative MIPS payment adjustments, and positive payment adjustments for the 2020 MIPS payment year based on the data prepared to support the 2017 performance period initial determination of clinician and special status eligibility (available via the NPI lookup on
The scoring model cannot fully reflect MIPS eligible clinicians' behavioral responses to MIPS. The scoring model assumes higher participation in MIPS quality reporting than under the PQRS. Other potential behavioral responses are not addressed in our scoring model. The scoring model assumes that quality measures submitted and the distribution of scores on those measures would be similar under Quality Payment Program Payment in the 2020 MIPS payment year as they were under the 2016 PQRS program.
The scoring model does not reflect the growth in Advanced APM participation between 2017 and 2018 (Quality Payment Program Years 1 and 2). After applying the other MIPS exclusions, the scoring model excluded an additional 70,732 QPs using the initial QP determination file.
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 76 through 79. Due the limitations above, there is considerable uncertainty around our estimates that is difficult to quantify in detail.
If regulations impose administrative costs on private entities, such as the time needed to read and interpret this final rule with comment period, we should estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that will review this final rule with comment period, we assume that the total number of commenters on the CY 2018 Quality Payment Program published proposed rule will be the number of reviewers of this final rule with comment period (1300 commenters). We acknowledge that this assumption may understate or overstate the costs of reviewing this rule. It is possible that not all commenters reviewed the proposed in detail, and it is also possible that some reviewers chose not to comment on the CY 2018 Quality Payment Program proposed rule. For these reasons, we believe that the number of commenters for the CY 2018 Quality Payment Program proposed rule would be a fair estimate of the number of reviewers of this final rule with comment period.
We also recognize that different types of entities are in many cases affected by mutually exclusive sections of this final rule with comment period. Therefore, for the purposes of our estimate, we assume that each reviewer reads approximately 50 percent of the final rule with comment period.
Using the wage information from the BLS for practice administrators (medical and health service managers) (Code 11-9111), we estimate that the cost of reviewing the proposed rule is $105.16 per hour, including overhead and fringe benefits, which we assume are 100 percent of the hourly wage for a practice administrator (
We welcomed any public comments on the approach in estimating the number of entities that would review the regulatory text that we described in CY 2018 Quality Payment Program proposed rule (82 FR 30244). We did not receive any specific comments related to the number of readers of this proposed rule, or that each reviewer
As required by OMB Circular A-4 (available at
We have not attempted to quantify the benefits of this final rule with comment period 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 payment adjustments 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 payment adjustments. As noted above, in CY 2020, we estimate that we will distribute approximately $118 million in payment adjustments on a budget-neutral basis, which represents the applicable percent for 2020 required under section 1848(q)(6)(B)(i) of the Act and excludes $500 million in additional MIPS payment adjustments for exceptional performance.
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 available for exceptional performance and the 5 percent APM Incentive Payment for QPs are only available from 2019 through 2024. Beginning in 2026, Medicare PFS payment rates for services furnished by QPs will receive a higher update than for services furnished by non-QPs. However, we are unable to estimate the number of QPs in those years, as we cannot project the number or types of Advanced APMs that will be made available in those years through future CMS initiatives proposed and implemented in those years, nor the number of QPs for those future Advanced APMs.
The percentage of the final score attributable to each performance category will change over time and we will continue to refine our scoring rules. The improvement activities category represents a 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 80 includes our estimate for MIPS payment adjustments ($118 million), the exceptional performance payment adjustments under MIPS ($500 million), and incentive payments to QPs (using the range described in the preceding analysis, approximately $675-$900 million). However, of these 3 elements, only the negative MIPS payment adjustments are shown as estimated decreases.
Based on National
Table 81 summarizes the regulatory review costs discussed in section VI.E. of this final rule with comment period, and the collection of information burden costs calculated in section IV.N. of this final rule with comment period.
As noted above, we estimate the regulatory review costs of $2.2 million for this final rule with comment period. In Table 81, we have prepared our analysis of collection of information burden costs to be consistent with guidance in accordance with OMB's April 2017 guidance on EO13771. The Order's guidance directs agencies to measure certain costs, including costs associated with “Medicare quality performance tracking”, using the estimates in the CY 2017 Quality Payment Program final rule as a baseline. The Order notes that regular updates to certain Medicare regulations make assessments of the incremental changes related to “performance tracking” included in a regulation much more useful than a comparison against
As shown in section IV.N. of this final rule with comment period, we estimate that this final rule with comment period will result in approximately $695 million in collection of information-related burden. However, we estimate that the incremental collection of information-related burden associated with this final rule with comment period is an approximately $13.9 million reduction relative to the baseline burden of continuing the policies and information collections set forth in the CY 2017 Quality Program final rule into CY 2018. Our burden estimates reflect several finalized policies that would reduce burden, including the reduction in the length of the CAHPS survey; and our proposal to allow MIPS eligible clinicians to form virtual groups, which would create efficiencies in data submission; and our proposal for significant hardship or other type of exception, including a new significant hardship exception for small practices for the advancing care information performance category.
Table 81 also shows the expected benefits associated with this final rule with comment period. We note that these expected benefits are qualitative in nature. We expect that the Quality Payment Program will result in quality improvements and improvements to the patients' experience of care as MIPS eligible clinicians respond to the incentives for high-quality care provided by the Program and implement care quality improvements in their clinical practices. While we cannot quantify these effects specifically at this time because we cannot project eligible clinicians' behavioral responses to the incentives offered under the Quality Payment Program, we nevertheless believe that changes to clinical care will result in care quality improvements for Medicare beneficiaries and other patients treated by eligible clinicians.
We estimate the implications of adopting the extreme and uncontrollable circumstance policy in this interim final rule with comment period for the transition year could reduce the amount redistributed in the 2019 MIPS payment year by approximately $19.9 million. We determined this estimate assessing the impact of this policy on the potential number of MIPS eligible clinicians and applying that to the regulatory impact described in the CY 2017 Quality Payment Program final rule. In the CY 2017 Quality Payment Program final rule, we estimated approximately $199 million in payment adjustments would be redistributed in MIPS on a budget neutral basis (81 FR 77535). Additionally, up to $500 million would be distributed for the additional MIPS payment adjustment for exceptional performance (81 FR 77535). We analyzed the MIPS eligibility file from the first eligibility run and estimated approximately 10 percent of MIPS eligible clinicians practiced in areas affected by the Hurricanes Harvey, Irma, and Maria. Based on this finding, we estimate approximately 10 percent of MIPS eligible clinicians with a negative payment adjustment may receive a neutral payment adjustment which represents approximately $19.9 million (10 percent of $199 million). We do not believe that this interim final rule with comment period would affect the overall distribution of the $500 million for exceptional performance.
Administrative practice and procedure, Biologics, Drugs, Health facilities, Health professions, Diseases, Medicare, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR chapter IV as set forth below:
Secs. 1102, 1871, and 1881(b)(l) of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)).
The revisions and additions read as follows:
(1) For any calendar year before 2019, EHR technology (which could include multiple technologies) certified under the ONC Health IT Certification Program that meets one of the following:
(iii) The definition for 2019 and subsequent years specified in paragraph (2) of this definition.
(2) For 2019 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—
(1) For the 2019 MIPS payment year, the low-volume threshold that applies to an individual eligible clinician or group that, during the low-volume threshold determination period described in paragraph (3) of this definition, has Medicare Part B allowed charges less than or equal to $30,000 or provides care for 100 or fewer Part B-enrolled Medicare beneficiaries.
(2) For the 2020 MIPS payment year and future years, the low-volume threshold that applies to an individual eligible clinician or group that, during the low-volume threshold determination period described in paragraph (3) of this definition, has Medicare Part B allowed charges less than or equal to $90,000 or provides care for 200 or fewer Part B-enrolled Medicare beneficiaries.
(3) The low-volume threshold determination period is a 24-month assessment period consisting of:
(i) An initial 12-month segment that spans from the last 4 months of the calendar year 2 years prior to the performance period through the first 8 months of the calendar year preceding the performance period; and
(ii) A second 12-month segment that spans from the last 4 months of the calendar year 1 year prior to the performance period through the first 8 months of the calendar year performance period. An individual eligible clinician or group that is identified as not exceeding the low-volume threshold during the initial 12-month segment will continue to be excluded under § 414.1310(b)(1)(iii) for the applicable year regardless of the results of the second 12-month segment analysis. For the 2019 MIPS payment year, each segment of the low-volume threshold determination period includes a 60-day claims run out. For the 2020 MIPS payment year and future years, each segment of the low-volume threshold determination period includes a 30-day claims run out.
(1) An individual MIPS eligible clinician who bills 100 or fewer patient-facing encounters (including Medicare telehealth services defined in section 1834(m) of the Act), as described in
(2) For purposes of this definition, a patient-facing encounter is an instance in which the individual MIPS eligible clinician or group bills for items and services furnished such as general office visits, outpatient visits, and procedure codes under the PFS, as specified by CMS.
(3) For purposes of this definition, the non-patient facing determination period is a 24-month assessment period consisting of:
(i) An initial 12-month segment that spans from the last 4 months of the calendar year 2 years prior to the performance period through the first 8 months of the calendar year preceding the performance period; and
(ii) A second 12-month segment that spans from the last 4 months of the calendar year 1 year prior to the performance period through the first 8 months of the calendar year performance period. An individual eligible MIPS clinician, group, or virtual group that is identified as non-patient facing during the initial 12-month segment will continue to be considered non-patient facing for the applicable year regardless of the results of the second 12-month segment analysis. For the 2019 MIPS payment year, each segment of the non-patient facing determination period includes a 60-day claims run out. For the 2020 MIPS payment year and future years, each segment of the non-patient facing determination period includes a 30-day claims run out.
(a)
(b)
(c)
(1)
(ii) [Reserved]
(2)
(ii) On behalf of a virtual group, the official designated virtual group representative must submit an election by December 31 of the calendar year prior to the start of the applicable performance period.
(iii) The submission of a virtual group election must include, at a minimum, information pertaining to each TIN and NPI associated with the virtual group and contact information for the virtual group representative.
(iv) Once an election is made, the virtual group representative must contact their designated CMS contact to update any election information that changed during a performance period at least one time prior to the start of an applicable submission period.
(3)
(i) Identifies the parties to the agreement by name of party, TIN, and NPI, and includes as parties to the agreement only the groups and solo practitioners that compose the virtual group.
(ii) Is executed on behalf of each party by an individual who is authorized to bind the party.
(iii) Expressly requires each member of the virtual group (and each NPI under each TIN in the virtual group) to participate in the MIPS as a virtual group and comply with the requirements of the MIPS and all other applicable laws and regulations (including, but not limited to, federal criminal law, False Claims Act, anti-kickback statute, civil monetary penalties law, Health Insurance Portability and Accountability Act of 1996, and physician self-referral law).
(iv) Identifies each NPI under each TIN in the virtual group and requires each TIN within a virtual group to notify all NPIs associated with the TIN regarding their participation in the MIPS as a virtual group.
(v) Sets forth the NPI's rights and obligations in, and representation by, the virtual group, including without limitation, the reporting requirements and how participation in the MIPS as a virtual group affects the ability of the NPI to participate in the MIPS outside of the virtual group.
(vi) Describes how the opportunity to receive payment adjustments will encourage each member of the virtual group (and each NPI under each TIN in the virtual group) to adhere to quality assurance and improvement.
(vii) Requires each party to the agreement to update its Medicare enrollment information, including the addition and deletion of NPIs billing through its TIN, on a timely basis in accordance with Medicare program requirements and to notify the virtual group of any such changes within 30 days after the change.
(viii) Is for a term of at least one performance period as specified in the formal written agreement.
(ix) Requires completion of a close-out process upon termination or expiration of the agreement that requires each party to the virtual group agreement to furnish all data necessary in order for the virtual group to aggregate its data across the virtual group.
(d)
(1) Individual eligible clinicians and individual MIPS eligible clinicians who are part of a TIN participating in MIPS at the virtual group level will have their performance assessed as a virtual group.
(2) Individual eligible clinicians and individual MIPS eligible clinicians who are part of a TIN participating in MIPS at the virtual group level must meet the definition of a virtual group at all times during the performance period for the MIPS payment year.
(3) Individual eligible clinicians and individual MIPS eligible clinicians who are part of a TIN participating in MIPS at the virtual group level must aggregate their performance data across multiple TINs in order for their performance to be assessed as a virtual group.
(4) MIPS eligible clinicians that elect to participate in MIPS at the virtual group level will have their performance assessed at the virtual group level across all four MIPS performance categories.
(5) Virtual groups must adhere to an election process established and required by CMS.
(c) For purposes of the 2021 MIPS payment year, the performance period for:
(1) The quality and cost performance categories is CY 2019 (January 1, 2019 through December 31, 2019).
(2) The advancing care information and improvement activities performance categories is a minimum of a continuous 90-day period within CY 2019, up to and including the full CY 2019 (January 1, 2019 through December 31, 2019).
(c) * * *
(4) The CMS Web Interface (for groups consisting of 25 or more eligible clinicians) for the quality, improvement activities, and advancing care information performance categories.
(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 at least one other data submission mechanism described in this section to submit their other quality information.
(d)
(a) * * *
(2)
(a) * * *
(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 the MIPS payment years 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 the MIPS payment years 2020 and 2021.
(b) * * *
(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 years 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 years 2020 and 2021.
(a) For purposes of the transition year of MIPS and future years, MIPS eligible clinicians or groups must submit data on MIPS improvement activities in one of the following manners:
(1) Via qualified registries; 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—
The revisions and additions read as follows:
(e)
(1)
(2) [Reserved]
(f)
(1) If a Shared Savings Program ACO does not report data on quality measures
(2) MIPS eligible clinicians who have elected to participate in a virtual group and who are also on a MIPS APM Participation List will be included in the assessment under MIPS for purposes of producing a virtual group score and under the APM scoring standard for purposes of producing an APM Entity score. The MIPS payment adjustment for these eligible clinicians is based solely on their APM Entity score.
(g) * * *
(1) * * *
(i)
(B)
(C)
(ii)
(
(
(
(
(B)
(C)
(2)
(3) * * *
(i) CMS assigns an improvement activities score for each MIPS APM for a MIPS performance period based on the requirements of the MIPS APM. The assigned improvement activities score applies to each APM Entity group for the MIPS performance period. In the event that the assigned score does not represent the maximum improvement activities score, an APM Entity may report additional activities.
(4) * * *
(i) Each Shared Savings Program ACO participant TIN must report data on the Advancing Care Information (ACI) performance category separately from the ACO, as specified in § 414.1375(b)(2). The ACO participant TIN scores are weighted according to the number of MIPS eligible clinicians in each TIN as a proportion of the total number of MIPS eligible clinicians in the APM Entity group, and then aggregated to determine an APM Entity score for the ACI performance category.
(ii) For APM Entities 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 score for the ACI performance category. The score for each MIPS eligible clinician is the higher of either:
(iii) In the event that a participant TIN in the Shared Savings Program or individual MIPS eligible clinician participating in a MIPS APM besides the Shared Savings Program receives an exception under section 1848(o)(2)(D) of the Act from the advancing care information performance category reporting requirements, such participant TIN or eligible clinician will be assigned a null score when CMS calculates the APM Entity's advancing care information performance category score under the APM scoring standard.
(A) If all participant TINs or MIPS eligible clinicians in an APM Entity have been excepted from reporting the advancing care information performance category, the performance category weight will be reweighted to zero for the APM Entity for that MIPS performance period.
(B) [Reserved]
(h)
(1) * * *
(i) For MIPS APMs that require use of the CMS Web Interface: 50 percent.
(ii) For Other MIPS APMs, 0 percent for 2017, 50 percent beginning in 2018.
(3) * * *
(i) For MIPS APMs that require use of the CMS Web Interface: 20 percent.
(ii) For Other MIPS APMs, 25 percent for 2017, 20 percent beginning in 2018.
(4) * * *
(i) For MIPS APMs that require use of the CMS Web Interface: 30 percent.
(ii) For Other MIPS APMs, 25 percent for 2017, 30 percent beginning in 2018.
(5)
(i) If CMS reweights the quality performance category to 0 percent:
(A) In 2017, the improvement activities performance category is reweighted to 25 percent and the advancing care information performance category is reweighted to 75 percent; and
(B) Beginning in 2018, the advancing care information performance category is reweighted to 80 percent and the improvement activities performance category will remain at 20 percent.
(ii) If CMS reweights the advancing care information performance category to 0 percent:
(A) In 2017, the quality performance category is reweighted to 75 percent and the improvement activities performance category will remain at 25 percent.
(B) Beginning in 2018, the quality performance category is reweighted to 80 percent and the improvement activities performance category will remain at 20 percent.
(i)
(a)
(b) * * *
(2) * * *
(ii) May claim an exclusion for each measure that includes an option for an exclusion.
(a)
(1)
(ii) For the cost performance category, measures are scored between 1 and 10 points. Performance is measured against a benchmark. Starting with the 2020 MIPS payment year, improvement scoring is available in the cost performance category.
(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. Benchmark data are separated into decile categories based on a percentile distribution. 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, as described in paragraph (b)(1)(i) of this section, which would not be published until after the performance period. For the 2019 MIPS payment year, 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) Subject to paragraph (b)(1)(viii) of this section, 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 years 2019 and 2020. Instead, these measures receive a score of 3 points in MIPS payment years 2019 and 2020. MIPS eligible clinicians do not receive zero points if the expected measure is submitted but is unable to be scored because it is below the data completeness requirement. Instead, these measures receive a score of 3 points in the 2019 MIPS payment year and a score of 1 point in the 2020 MIPS payment year, except if the measure is submitted by a small practice. Measures below the data completeness requirement submitted by a small practice receive a score of 3 points in the 2020 MIPS payment year.
(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 and measures that have a measure benchmark but are redesignated as pay for reporting for all Shared Savings Program accountable care organizations by the Shared Savings Program, CMS will recognize the measure was submitted but exclude the measure from being scored as long as the data completeness requirement is met. CMS Web Interface measures that
(ix) Measures submitted by MIPS eligible clinicians are scored against measure benchmarks 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.
(A) MIPS eligible clinicians that submit measures via claims, qualified registry, EHR, or QCDR submission mechanisms, and submit more than the required number of measures are scored on the required measures with the highest measure achievement points. Beginning in the 2021 MIPS payment year, MIPS eligible clinicians that report a measure via more than one submission mechanism can be scored on only one submission mechanism for that measure, which will be the submission mechanism with the highest measure achievement points. Groups that submit via these submission options may also submit and be scored on CMS-approved survey vendor for CAHPS for MIPS submission mechanisms.
(B) Groups that submit measures via the CMS Web Interface may also submit and be scored on CMS-approved survey vendor for CAHPS for MIPS submission mechanisms.
(xiii) CMS will identify topped out measures in the benchmarks published for each Quality Payment Program year.
(A) For the 2020 MIPS payment year, selected topped out measures identified by CMS will receive no more than 7 measure achievement points, provided that the measure benchmarks for the applicable submission mechanisms are identified as topped out in the benchmarks published for the 2018 MIPS performance period.
(B) Beginning with the 2021 MIPS payment year, a measure, except for measures in the CMS Web Interface, whose benchmark is identified as topped out for 2 or more consecutive years will receive no more than 7 measure achievement points in the second consecutive year it is identified as topped out, and beyond.
(xiv) Measure bonus points are available for measures determined to be high priority measures when two or more high priority measures are reported.
(A) Measure bonus points are not available for the first reported high priority measure which is required to be reported. To qualify for measure bonus points, each measure must be reported with sufficient case volume to meet the required case minimum, meet the required data completeness criteria, and not have a zero percent performance rate. Measure bonus points may be included in the calculation of the quality performance category percent score regardless of whether the measure is included in the calculation of the total measure achievement points.
(B) Outcome and patient experience measures receive two measure bonus points.
(C) Other high priority measures receive one measure bonus point.
(D) Measure bonus points for high priority measures cannot exceed 10 percent of the total available measure achievement points for the 2019 and 2020 MIPS payment years.
(E) If the same high priority measure is submitted via two or more submission mechanisms, the measure will receive high priority measure bonus points only once for the measure beginning in the 2021 MIPS payment year.
(xv) One measure 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 available measure achievement points for the 2019 and 2020 MIPS payment years. If the same measure is submitted via 2 or more submission mechanisms, the measure will receive measure bonus points only once for the measure beginning in the 2021 MIPS payment year.
(xvi) Improvement scoring is available to MIPS eligible clinicians that demonstrate improvement in performance in the current MIPS performance period compared to performance in the performance period immediately prior to the current MIPS performance period based on measure achievement points.
(A) Improvement scoring is available when the data sufficiency standard is met, which means when data are available and a MIPS eligible clinician has a quality performance category achievement percent score for the previous performance period and the current performance period.
(
(
(
(B) The improvement percent score may not total more than 10 percentage points.
(C) The improvement percent score is assessed at the performance category level for the quality performance category and included in the calculation of the quality performance category percent score as described in paragraph (b)(1)(xvii) of this section.
(
(
(
(
(
(D) For the purpose of improvement scoring methodology, the term “quality performance category achievement percent score” means the total measure achievement points divided by the total available measure achievement points, without consideration of measure bonus points or improvement percent score.
(E) For the purpose of improvement scoring methodology, the term “improvement percent score” means the score that represents improvement for the purposes of calculating the quality performance category percent score as described in paragraph (b)(1)(xvii) of this section.
(F) For the purpose of improvement scoring methodology, the term “fully participate” means the MIPS eligible clinician met all requirements in §§ 414.1330 and 414.1340.
(xvii) A MIPS eligible clinician's quality performance category percent score is the sum of all the measure achievement points assigned for the measures required for the quality performance category criteria plus the measure bonus points in paragraph (b)(1)(xiv) of this section and measure bonus points in paragraph (b)(1)(xv) of this section. The sum is divided by the sum of total available measure achievement points. The improvement percent score in paragraph (b)(1)(xvi) of this section is added to that result. The quality performance category percent score cannot exceed 100 percentage points.
(xviii) Beginning with the 2018 MIPS performance period, measures significantly impacted by ICD-10 updates, as determined by CMS, will be assessed based only on the first 9 months of the 12-month performance period. For purposes of this paragraph, CMS will make a determination as to whether a measure is significantly impacted by ICD-10 coding changes during the performance period. CMS will publish on the CMS Web site which measures require a 9-month assessment process by October 1st of the performance period if technically feasible, but by no later than the beginning of the data submission period at § 414.1325(f)(1).
(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 cost performance category percent score is the sum of the following, not to exceed 100 percent:
(A) The total number of achievement points earned by the MIPS eligible clinician divided by the total number of available achievement points; and
(B) The cost improvement score, as determined under paragraph (b)(2)(iv) of this section.
(iv) Cost improvement scoring is available to MIPS eligible clinicians that demonstrate improvement in performance in the current MIPS performance period compared to their performance in the immediately preceding MIPS performance period.
(A) The cost improvement score is determined at the measure level for the cost performance category.
(B) The cost improvement score is calculated only when data sufficient to measure improvement is available. Sufficient data is available when a MIPS eligible clinician or group participates in MIPS using the same identifier in 2 consecutive performance periods and is scored on the same cost measure(s) for 2 consecutive performance periods. If the cost improvement score cannot be calculated because sufficient data is not available, then the cost improvement score is zero.
(C) The cost improvement score is determined by comparing the number of measures with a statistically significant change (improvement or decline) in performance; a change is determined to be significant based on application of a t-test. The number of cost measures with a significant decline is subtracted from the number of cost measures with a significant improvement, with the result divided by the number of cost measures for which the MIPS eligible clinician or group was scored for two consecutive performance periods. The resulting fraction is then multiplied by the maximum improvement score.
(D) The cost improvement score cannot be lower than zero percentage points.
(E) The maximum cost improvement score for the 2020 MIPS payment year is 1 percentage point.
(v) A cost performance category percent score is not calculated if a MIPS eligible clinician 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.
(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 or recognized 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. A practice is certified or recognized 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 number of medical organizations and meet national guidelines, as determined by the Secretary. The Secretary must determine that these certifying bodies must have 500 or more certified member
(
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(
(
(
(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) For the transition year, to receive full credit as a certified or recognized patient-centered medical home or comparable specialty a TIN that is reporting must include at least one practice site 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.
(x) For the 2020 MIPS payment year and future years, to receive full credit as a certified or recognized patient-centered medical home or comparable specialty practice, at least 50 percent of the practice sites within the TIN must be recognized as a patient-centered medical home or comparable specialty practice.
(4)
(A) A MIPS eligible clinician earns a base score by reporting the numerator (of at least one) and denominator or a yes/no statement or an exclusion; 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 may earn the following bonus scores:
(
(
(
(c)
Final score = [(quality performance category percent score × quality performance category weight) + (cost performance category percent 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 + [the complex patient bonus + the small practice bonus], not to exceed 100 points.
If a MIPS eligible clinician is scored on fewer than 2 performance categories, he or she receives a final score equal to the performance threshold.
(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)
(i) CMS determines there are not sufficient measures and activities applicable and available to MIPS eligible clinicians pursuant to section 1848(q)(5)(F) of the Act.
(ii) CMS estimates that the proportion of eligible professionals who are meaningful EHR users is 75 percent or greater pursuant to section 1848(q)(5)(E)(ii) of the Act.
(iii) A significant hardship exception or other type of exception is granted to a MIPS eligible clinician for the advancing care information performance category pursuant to section 1848(o)(2)(D) of the Act.
(3)
(i) For MIPS eligible clinicians and groups, the complex patient bonus is calculated as follows: [The average HCC risk score assigned to beneficiaries (pursuant to the HCC risk adjustment model established by CMS pursuant to section 1853(a)(1) of the Act) seen by the MIPS eligible clinician or seen by clinicians in a group] + [the dual eligible ratio × 5].
(ii) For APM entities and virtual groups, the complex patient bonus is calculated as follows: [The beneficiary weighted average HCC risk score for all MIPS eligible clinicians, and if technically feasible, TINs for models and virtual groups which rely on complete TIN participation within the APM entity or virtual group, respectively] + [the average dual eligible ratio for all MIPS eligible clinicians, and if technically feasible, TINs for models and virtual groups which rely on complete TIN participation, within the APM entity or virtual group, respectively, × 5].
(iii) The complex patient bonus cannot exceed 5.0.
(4)
(d)
(e)
(1)
(2)
(i)
(ii)
(3) [Reserved].
(4)
(5)
(6)
(ii)
(iii)
(iv)
(v)
(A)
(B) [Reserved].
(b)
(c)
(d)
(a)
(b)
(c)
(d)
The revisions and addition read as follows:
(a) * * *
(1) MIPS data may be submitted by third party intermediaries on behalf of a MIPS eligible clinician, group or virtual group by:
(5) All data submitted to CMS by a third party intermediary on behalf of a MIPS eligible clinician, group or virtual group must be certified by the third party intermediary to the best of its knowledge as true, accurate, and complete. Such certification must accompany the submission and be made at the time of the submission.
(b)
(e)
(3) CAHPS for MIPS survey. Although the CAHPS for MIPS survey is included in the MIPS measure set, we consider the changes that need to be made to the CAHPS for MIPS survey 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 QCDR quality measure for purposes of individual MIPS eligible clinicians reporting the CAHPS for MIPS survey via a QCDR.
(f)
(1) For QCDR 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.
(2) For MIPS quality measures, the QCDR only needs to submit the MIPS measure numbers or specialty-specific measure sets (if applicable). CMS expects that QCDRs reporting on MIPS measures, retain and use the MIPS measure specifications as they exist under the program year.
(3) The QCDR must publicly post the measure specifications no later than 15 calendar days following CMS approval of the measure specifications for each QCDR measure it intends to submit for MIPS. The QCDR may use any public format it prefers. Immediately following the posting of the measure specification, the QCDR must provide CMS with the link to where this information is posted.
(g)
(i)
(j) * * *
(2) The entity must retain all data submitted to CMS for purposes of MIPS for 6 years from the end of the MIPS performance period.
(3) For the purposes of auditing, CMS may request any records or data retained for the purposes of MIPS for up to 6 years from the end of the MIPS performance period.
(b) * * *
(4) The performance threshold for the 2019 MIPS payment year is 3 points.
(5) The performance threshold for the 2020 MIPS payment year is 15 points.
(d) * * *
(3) The additional performance threshold for the 2019 MIPS payment year is 70 points.
(4) The additional performance threshold for the 2020 MIPS payment year is 70 points.
The revision reads as follows:
(b)
The revisions and addition read as follows:
(c)
(2)
(3) * * *
(i) * * *
(A) For QP Performance Periods 2017, 2018, 2019, and 2020, 8 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities; or
(4)
(A) For QP Performance Period 2017, 2.5 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
(B) For QP Performance Period 2018, 2.5 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
(C) For QP Performance Period 2019, 3 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
(D) For QP Performance Period 2020, 4 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
(E) For QP Performance Periods 2021 and later, 5 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities.
(ii) [Reserved]
(7)
The revisions and addition read as follows:
(a) * * *
(3) * * *
(i) Requires APM Entities to bear 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) of this section.
(c)
(2) At least one of the quality measures used in the payment arrangement must have an evidence-based focus, be reliable and valid, and meet at least one of the following criteria:
(3) To meet the quality measure use criterion, a payment arrangement must use an outcome measure if there is an applicable outcome measure on the MIPS quality measure list.
(d)
(1)
(2)
(3)
(i) For the 2019 and 2020 QP Performance Periods, 8 percent of the total combined revenues from the payer to providers and other entities under the payment arrangement if financial risk is expressly defined in terms of revenue; or
(4)
(i) For QP Performance Period 2019, 3 percent of the average estimated total revenue of the participating providers or other entities under the payer.
(ii) For QP Performance Period 2020, 4 percent of the average estimated total revenue of the participating providers or other entities under the payer.
(iii) For QP Performance Periods 2021 and later, 5 percent of the average estimated total revenue of the participating providers or other entities under the payer.
(8)
The revisions and addition read as follows:
(a)
(2) For Advanced APMs in which APM Entities do not include eligible clinicians on a Participation List but do include eligible clinicians on an Affiliated Practitioner List, the Affiliated Practitioner List is used to identify the eligible clinicians for purposes of QP determinations.
(3) For Advanced APMs in which some APM Entities may include eligible clinicians on a Participation List and other APM Entities may only include eligible clinicians on an Affiliated Practitioner List depending on the type of APM Entity, paragraph (a)(1) of this section applies to APM Entities that may include eligible clinicians on a Participation List, and paragraph (a)(2) of this section applies to APM Entities that may only include eligible clinicians on an Affiliated Practitioner List.
(b)
(2)
(c) * * *
(3) An eligible clinician is a QP for a year under the Medicare Option 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). An eligible clinician is a QP for the year under the All-Payer Combination Option if the eligible clinician individually, or as part of an APM Entity group, 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(b)(1) and (3).
(4) * * *
(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 QP payment amount threshold or the QP patient count threshold, or the eligible clinician is an Affiliated Practitioner; and
(6) Notwithstanding paragraph (c)(4) of this section, an eligible clinician is not a QP for a year if one or more of the APM Entities in which the eligible clinician participates voluntarily or involuntarily terminates from the Advanced APM before the end of the QP Performance Period, and the eligible clinician does not individually achieve a Threshold Score that meets or exceeds the QP payment amount threshold or QP patient count threshold based on participation in the remaining non-terminating APM Entities.
(7) Advanced APMs that start or end during the QP Performance Period:
(i) Notwithstanding paragraph (a) of this section and §§ 414.1435 and 414.1440, CMS makes QP determinations and Partial QP determinations for the APM Entity group or individual eligible clinician under § 414.1425(b) for Advanced APMs that start or end during the QP Performance Period and that are actively tested for 60 or more continuous days during the QP Performance Period using claims data for services furnished during those dates on which the Advanced APM is actively tested. For Advanced APMs that start active testing during the QP Performance Period, CMS performs QP and Partial QP determinations during the QP Performance Period using claims data for services furnished from the start of active testing of the Advanced APM through each of the QP determination dates that occur on or after the Advanced APM has been actively tested for 60 or more continuous days: March 31, June 30, and August 31. For Advanced APMs that end active testing during the QP Performance Period, CMS performs QP and Partial QP determinations using claims data for services furnished from January 1 or the start of active testing, whichever occurs later, through the final day of active testing of the Advanced APM for each of the QP determination dates that occur on or after the Advanced APM has been actively tested for 60 or more continuous days during that QP Performance Period: March 31, June 30, and August 31.
(ii) For QP determinations specified under paragraph (c)(4) of this section and Partial QP determinations under paragraph (d)(2) of this section, QP determinations are made using claims data for the full QP Performance Period even if the eligible clinician participates in one or more Advanced APMs that start or end during the QP Performance Period.
(d) * * *
(1) An eligible clinician is a Partial QP for a year under the Medicare Option if the eligible clinician is in an APM Entity group that achieves Threshold Score that meets or exceeds the corresponding Partial QP payment
(4) Notwithstanding paragraph (d)(2) of this section, an eligible clinician is not a Partial QP for a year if one or more of the APM Entities in which the eligible clinician participates voluntarily or involuntarily terminates from the Advanced APM before the end of the QP Performance Period, and the eligible clinician does not individually achieve a Threshold Score that meets or exceeds the Partial QP payment amount threshold or Partial QP patient count threshold based on participation in the remaining non-terminating APM Entities.
20. Section 414.1435 is amended by revising paragraphs (a) introductory text, (a)(1) and (2), (b)(1), (b)(3) and (4), and (d) to read as follows:
(a)
(1)
(2)
(b) * * *
(1)
(3)
(4)
(d)
(a) * * *
(1) * * *
(iii) Under Title XIX in a State in which no Medicaid APM or Medicaid Medical Home Model that is an Other Payer Advanced APM is available.
(2) Payments and associated patient counts under paragraph (a)(1)(iii) of this section are included in the numerator and denominator as specified in paragraphs (b)(2) and (3) and paragraphs (c)(2) and (3) of this section for an eligible clinician if CMS determines that there is at least one Medicaid APM or Medicaid Medical Home Model that is an Other Payer Advanced APM available in the county where the eligible clinician sees the most patients during the QP Performance Period, and that the eligible clinician is not ineligible to participate in the Other Payer Advanced APM based on their specialty.
(b)
(2)
(3)
(c)
(2)
(3)
(4)
(d)
(2) An APM Entity may request that CMS make QP determinations at the APM Entity level, and an eligible clinician may request that CMS make QP determinations at the eligible clinician level. CMS makes QP determinations at either the APM Entity or eligible clinician level. Eligible clinicians assessed at the eligible clinician level under the Medicare Option at § 414.1425(b)(2) will be assessed at the eligible clinician level only under the All-Payer Combination Option.
(3) CMS uses data at the same level for the Medicare and other payer portions of Threshold Score calculations under the All-Payer Combination Option. When QP determinations are made at the eligible clinician level, and if the Medicare Threshold Score for the
(e)
(2) To request a QP determination under the All-Payer Combination Option, for each payment arrangement submitted as set forth in paragraph (e)(1) of this section, the APM Entity or eligible clinician must include the amount of revenue for services furnished through the payment arrangement, the total revenue received from all payers except those excluded as provided in paragraph (a)(2) of this section, the number of patients furnished any service through the arrangement, and the total number of patients furnished any services, except those excluded as provided in paragraph (a)(2) of this section.
(3) An APM Entity or eligible clinician must submit the information specified in paragraph (e)(2) of this section in a form and manner specified by CMS. An APM Entity or eligible clinician may submit the information specified in paragraph (e)(2) of this section for the following periods of time in the relevant QP Performance Period: January 1 through March 31, January 1 through June 30, and January 1 through August 31.
(4) To request a QP determination under the All-Payer Combination Option, an APM Entity or eligible clinician must submit this information to CMS no later than the QP Determination Submission Deadline, which is December 1 of the calendar year that is 2 years prior to the payment year.
(f)
(2)
(g)
(a)
(b)
(2)
(c)
(2) If an eligible clinician submits information showing that a payment arrangement requires that the eligible clinician must use CEHRT as defined in § 414.1305 to document and communicate clinical care, CMS will presume that the CEHRT criterion in § 414.1420(b) is satisfied for that payment arrangement.
(3) If a payment arrangement has no outcome measure, the payer, APM Entity, or eligible clinician requesting a determination of whether a payment arrangement meets the Other Payer Advanced APM criteria must certify that there is no available or applicable outcome measure on the MIPS measure list.
(d)
(e)
(f)
(a)
(b)
(1) Any of the information CMS relied on in making the QP determination was inaccurate or misleading.
(2) The QP is terminated from an Advanced APM or Other Payer Advanced APM during the QP Performance Period or Incentive Payment Base Period; or
(3) The QP is found to be in violation of the terms of the relevant Advanced APM or any relevant Federal, State, or tribal statute or regulation during the QP Performance Period or Incentive Payment Base Period.
(c)
(d)
(i) Who CMS determines is not in compliance with all Medicare conditions of participation and the terms of the relevant Advanced APM in which they participate during the QP Performance Period or Incentive Payment Base Period;
(ii) Who is terminated by an APM or Advanced APM during the QP Performance Period or Incentive Payment Base Period; or
(iii) Whose APM Entity is terminated by an APM or Advanced APM for non-compliance with any Medicare condition of participation or the terms of the relevant Advanced APM in which they participate during the QP Performance Period or Incentive Payment Base Period.
(2) CMS may reopen, revise, and recoup an APM Incentive Payment that was made in error in accordance with procedures similar to those set forth at §§ 405.980 through § 405.986 and §§ 405.370 through 405.379 of this chapter or as established under the relevant APM.
(e)
(2) An APM Entity or eligible clinician that submits information to CMS under § 414.1445 for assessment under the All-Payer Combination Option or § 414.1440 for QP determinations must maintain such books, contracts, records, documents, and other evidence as necessary to enable the audit of an Other Payer Advanced APM determination, QP determinations, and the accuracy of APM Incentive Payments for a period of 6 years from the end of the QP Performance Period or from the date of completion of any audit, evaluation, or inspection, whichever is later.
(3) A payer, APM Entity or eligible clinician that submits information to CMS under §§ 414.1440 or 414.1445 must provide such information and supporting documentation to CMS upon request.
The following appendix will not appear in the Code of Federal Regulations.
In the CY 2018 Quality Payment Program proposed rule (82 FR 30010), we proposed to include these additional improvement activities in the Improvement Activities Inventory for the Quality Payment Program Year 2 and future years based on guidelines discussed in the CY 2017 Quality Payment Program final rule at (81 FR 77190) and finalized in section II.C.6.e.(7)(b) of this final rule with comment period. These may include one or more of the following criteria:
• 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;
• Activities that may be considered for an advancing care information bonus;
• Representative of activities that multiple individual 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.
Environmental Protection Agency (EPA).
Final rule.
This rule establishes initial air quality designations for most areas in the United States, including most areas of Indian country, for the 2015 primary and secondary national ambient air quality standards (NAAQS) for ozone. In this action, the Environmental Protection Agency (EPA) is designating 2,646 counties, including Indian Country located in those counties, two separate areas of Indian Country, and five territories as Attainment/Unclassifiable and three counties as Unclassifiable.
This final rule is effective on January 16, 2018.
The EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2017-0548. All documents in the docket are listed in the index at
In addition, the EPA has established a Web site for this rulemaking at:
For general questions concerning this action, please contact Denise Scott, U.S. EPA, Office of Air Quality Planning and Standards, Air Quality Planning Division, C539-04, Research Triangle Park, North Carolina 27711, telephone: (919) 541-4280, email: at
On October 1, 2015, the EPA revised both the primary and secondary NAAQS for ozone to a level of 0.070 parts per million (ppm) (annual fourth-highest daily maximum 8-hour average concentration, averaged over 3 years).
The purpose of this action is to announce and promulgate initial area designations for most counties
In this action, the EPA is designating as Attainment/Unclassifiable 2,646 counties for which the states recommended a designation of Attainment or Attainment/Unclassifiable. These are counties with one or more monitors attaining the 2015 ozone NAAQS
In addition, the state of Washington recommended a designation of Unclassifiable for three counties—Benton, Franklin, and Walla Walla. Benton County and Franklin County are part of the Kennewick Richland, Washington, CBSA.
Consistent with the EPA's “Policy for Establishing Separate Air Quality Designations for Areas of Indian Country” (December 20, 2011), the EPA is designating two areas of Indian country (Fond du Lac Band of Lake Superior Chippewa Indians and Forest County Potawatomi Community) as separate Attainment/Unclassifiable areas.
Section 107(d)(2)(B) of the CAA provides that initial area designations under CAA section 107(d)(1) are not subject to the notice-and-comment rulemaking procedures of the Administrative Procedure Act (APA), but that “nothing herein shall be construed as precluding such public notice and comment whenever possible.” The EPA is promulgating these designations for 2,649 counties including Indian Country located in those counties, two separate areas of Indian Country, and five territories without notice-and-comment, because we believe that the designations pursuant to this final action are noncontroversial and the designations are consistent with the recommendations of the states and tribes in which these counties and tribal lands are located. Any party that is concerned about one or more of the area designations finalized in this action may file a petition for reconsideration with the Administrator.
Ground-level ozone is a gas that is formed by the reaction of volatile organic compounds (VOCs) and oxides of nitrogen (NO
As discussed in Section I of this preamble, on October 1, 2015, the EPA revised both the primary and secondary NAAQS for ozone to a level of 0.070 ppm (annual fourth-highest daily maximum 8-hour average concentration, averaged over 3 years) to provide increased protection of public health and the environment.
The EPA lowered the primary 8-hour ozone standard from 0.075 ppm to 0.070 ppm to protect against health effects associated with ozone exposure, including a number of harmful effects on the respiratory system, including difficulty breathing, inflammation of the airways, and aggravation of lung diseases such as asthma and chronic obstructive pulmonary disease, and increased premature death from heart or lung disease. The EPA also revised the level of the secondary 8-hour ozone standard from 0.075 ppm to 0.070 ppm to protect against welfare effects, including impacts on sensitive vegetation and forested ecosystems.
When the EPA promulgates a new or revised NAAQS, the EPA is required to designate areas as Nonattainment, Attainment, or Unclassifiable, pursuant to section 107(d)(1) of the CAA. Section 107(d)(1)(A)(i) of the CAA defines a Nonattainment area as, “any area that does not meet (or that contributes to ambient air quality in a nearby area that does not meet) the national primary or secondary ambient air quality standard for the pollutant.” If an area meets either prong of this definition, then the EPA is obligated to designate the area as “Nonattainment.” CAA section 107(d)(1)(A)(ii) defines an Attainment area as any area that does not meet the definition of Nonattainment and that meets the NAAQS. CAA section 107(d)(1)(A)(iii) provides that any area that the EPA cannot designate on the basis of available information as meeting or not meeting the standards should be designated as “Unclassifiable.” Historically for ozone, the EPA designates most areas that do not meet the definition of Nonattainment as “Unclassifiable/Attainment.” In a few instances, based on circumstances where some monitoring data are available but is not sufficient for a determination that an area is or is not attaining the NAAQS, the EPA has designated an area as “Unclassifiable.”
Section 107(d)(1)(B) of the CAA requires the EPA to issue initial area designations within 2 years of promulgating a new or revised NAAQS. However, if the Administrator has insufficient information to make these designations within that time frame, the EPA has the authority to extend the deadline for designation decisions by up to 1 additional year.
By not later than 1 year after the promulgation of a new or revised NAAQS, each state governor is required by the CAA to recommend air quality designations, including the appropriate boundaries for areas, to the EPA. The EPA reviews those state recommendations and is authorized to make any modifications the Administrator deems necessary. The statute does not define the term “necessary,” but the EPA interprets this to authorize the Administrator to modify designation recommendations that are inconsistent with the statutory definitions of nonattainment, attainment and unclassifiable, including modification of recommended boundaries for nonattainment areas that are not supported by the facts or analysis. If the EPA intends to modify a state's recommendation, section 107(d)(1)(B) of the CAA requires the EPA to notify the state of any such intended modifications not less than 120 days prior to the EPA's promulgation of the final designation. These notifications are commonly known as the “120-day letters.” If the state does not agree with the EPA's intended modification, the 120-day period provides an opportunity for the state to demonstrate to the EPA why it believes any modification proposed by the EPA is inappropriate. If a state fails to provide any recommendation for an area, in whole or in part, the EPA must promulgate a designation that the Administrator deems appropriate.
The terms “contributes to” and “nearby” in the definition of a nonattainment area are not defined in the statute and the EPA has discretion to interpret these ambiguous terms, based on considerations such as the nature of a specific pollutant, the types of sources that may contribute to violations, the form of the standards for the pollutant, and other relevant information. The EPA does not interpret the statute to require the agency to establish bright line tests or thresholds for what constitutes “contribution” or “nearby” for purposes of designations.
Section 301(d) of the CAA authorizes the EPA to approve eligible Indian tribes to implement provisions of the CAA on Indian reservations and other areas within the tribes' jurisdiction. The Tribal Authority Rule (TAR) (40 CFR part 49), which implements section 301(d) of the CAA, sets forth the criteria and process for tribes to apply to the EPA for eligibility to administer CAA programs. The designations process contained in section 107(d) of the CAA is included among those provisions determined to be appropriate by the EPA for treatment of tribes in the same manner as states. Under the TAR, tribes generally are not subject to the same submission schedules imposed by the CAA on states. As authorized by the TAR, tribes may seek eligibility to
When the EPA establishes a new or revised NAAQS, the CAA requires the EPA to designate all areas of the United States as either nonattainment, attainment, or unclassifiable. This final action addresses designation determinations for 2,649 counties including Indian Country located in those counties, two separate areas of Indian country, and five territories for the 2015 ozone NAAQS. Area designations address environmental justice concerns by ensuring that the public is properly informed about the air quality in an area. In locations where air quality does not meet the NAAQS, the CAA requires relevant state authorities to initiate appropriate air quality management actions to ensure that all those residing, working, attending school, or otherwise present in those areas are protected, regardless of minority and economic status.
This action is exempt from review by the Office of Management and Budget because it responds to the CAA requirement to promulgate air quality designations after promulgation of a new or revised NAAQS.
This action is not an Executive Order 13771 regulatory action because actions such as air quality designations after promulgating a new revised NAAQS are exempt under Executive Order 12866.
This action does not impose an information collection burden under the PRA. This action fulfills the non-discretionary duty for the EPA to promulgate air quality designations after promulgation of a new or revised NAAQS and does not contain any information collection activities.
This designation action under CAA section 107(d) is not subject to the RFA. The RFA applies only to rules subject to notice-and-comment rulemaking requirements under the APA, 5 U.S.C. 553, or any other statute. Section 107(d)(2)(B) of the CAA explicitly provides that designations are exempt from the notice-and-comment provisions of the APA. In addition, designations under CAA section 107(d) are not among the list of actions that are subject to the notice-and-comment rulemaking requirements of CAA section 307(d).
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538 and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. The division of responsibility between the federal government and the states for purposes of implementing the NAAQS is established under the CAA.
This action does not have tribal implications. It will neither impose substantial direct compliance costs on federally recognized tribal governments, nor preempt tribal law. The CAA provides for states and eligible tribes to develop plans to regulate emissions of air pollutants within their areas, as necessary, based on the designations. The TAR provides tribes the opportunity to apply for eligibility to develop and implement CAA programs, such as programs to attain and maintain the ozone NAAQS, but it leaves to the discretion of the tribe the decision of whether to apply to develop these programs and which programs, or appropriate elements of a program, the tribe will seek to adopt. This rule does not have a substantial direct effect on one or more Indian tribes.
The EPA interprets Executive Order 13045 as applying to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not establish an environmental standard intended to mitigate health or safety risks.
This action is not subject to Executive Order 13211 because it is not a significant regulatory action under Executive Order 12866.
This rulemaking does not involve technical standards.
The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). The documentation for this determination is contained in Section VII of this preamble, “Environmental Justice Concerns.”
This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the U.S. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
Section 307(b)(1) of the CAA indicates which Federal Courts of Appeal have venue for petitions for review of final actions by the EPA. This section provides, in part, that petitions for review must be filed in the Court of Appeals for the District of Columbia Circuit for: (i) “Any nationally applicable regulations promulgated, or final actions taken, by the Administrator,” or (ii) when such action is locally or regionally applicable, “if such action is based on a determination of nationwide scope or effect and if in taking such action the Administrator finds and publishes that such action is based on such a determination.”
This rule designates areas for the 2015 ozone NAAQS is “nationally applicable” within the meaning of CAA section 307(b)(1). This rule establishes designations for areas across the U.S. for the 2015 ozone NAAQS. At the core of this rulemaking is the EPA's interpretation of the designation provisions in section 107(d)(1) of the
For the same reasons, the Administrator also is determining that the final designations are of nationwide scope and effect for the purposes of CAA section 307(b)(1). This is particularly appropriate because, in the report on the 1977 Amendments that revised section 307(b)(1) of the CAA, Congress noted that the Administrator's determination that an action is of “nationwide scope or effect” would be appropriate for any action that has a scope or effect beyond a single judicial circuit. H.R. Rep. No. 95-294 at 323, 324, reprinted in 1977 U.S.C.C.A.N. 1402-03. Here, the scope and effect of this rulemaking extends to numerous judicial circuits since the designations apply to areas across the country. In these circumstances, CAA section 307(b)(1) and its legislative history calls for the Administrator to find the rule to be of “nationwide scope or effect” and for venue to be in the District of Columbia Circuit.
Thus, any petitions for review of final designations must be filed in the Court of Appeals for the District of Columbia Circuit within 60 days from the date final action is published in the
Environmental protection, Air pollution control, National parks, Wilderness areas.
For the reasons set forth in the preamble, 40 CFR part 81 is amended as follows:
42 U.S.C. 7401,
| 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 |