| Page Range | 59269-60332 | |
| FR Document |
| Page and Subject | |
|---|---|
| 83 FR 60331 - National Family Week, 2018 | |
| 83 FR 59423 - Sunshine Act Meetings | |
| 83 FR 59424 - Sunshine Act Meetings | |
| 83 FR 59380 - Sunshine Act Meeting | |
| 83 FR 59383 - Sunshine Act Meeting | |
| 83 FR 59417 - U.S.-EU Trade Agreement: Advice on the Probable Economic Effect of Providing Duty-Free Treatment for Currently Dutiable Imports; Institution of Investigation and Scheduling of Hearing | |
| 83 FR 59377 - Environmental Impact Statements; Notice of Availability | |
| 83 FR 59442 - R.J. Corman Railroad Group, LLC and R.J. Corman Railroad Company, LLC-Acquisition of Control Exemption-Nashville and Western Railroad Corp. and Nashville & Eastern Railroad Corp. | |
| 83 FR 59442 - Certification Pursuant to Section 704 I(F)(3) of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2018 | |
| 83 FR 59398 - Florida; Amendment No. 7 to Notice of a Major Disaster Declaration | |
| 83 FR 59408 - Public Meeting of the National Geospatial Advisory Committee | |
| 83 FR 59390 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
| 83 FR 59391 - Agency Information Collection Activities: Submission for OMB Review; Comment Request | |
| 83 FR 59362 - Determination of Overfishing or an Overfished Condition | |
| 83 FR 59419 - Request for Letters of Intent To Apply for 2019 Pro Bono Innovation Fund Grants | |
| 83 FR 59379 - Proposed Information Collection Request; Comment Request; Distribution of Offsite Consequence Analysis Information Under Section 112(r)(7)(H) of the Clean Air Act (CAA), as Amended-EPA No. 1981.07, OMB Control Number 2050-0172 | |
| 83 FR 59348 - Air Plan Approval; Missouri; Emissions Inventory for the Missouri Jackson County and Jefferson County 2010 Sulfur Dioxide National Ambient Air Quality Standard Nonattainment Areas | |
| 83 FR 59378 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generator Standards Applicable to Laboratories Owned by Eligible Academic Entities. | |
| 83 FR 59400 - Changes in Flood Hazard Determinations | |
| 83 FR 59444 - Ithaca Central Railroad, LLC-Lease and Operation Exemption-Norfolk Southern Railway Company | |
| 83 FR 59443 - Watco Holdings, Inc.-Continuance in Control Exemption-Ithaca Central Railroad, LLC | |
| 83 FR 59385 - Submission for OMB Review; Comment Request | |
| 83 FR 59377 - Agency Information Collection Activities; Proposed Collection; Comment Request; General Hazardous Waste Facility Standards | |
| 83 FR 59393 - Proposed Flood Hazard Determinations | |
| 83 FR 59394 - Changes in Flood Hazard Determinations | |
| 83 FR 59307 - Drawbridge Operation Regulation; Delaware River, Pennsauken Township, NJ | |
| 83 FR 59385 - Agenda; Board Meeting | |
| 83 FR 59449 - Advisory Committee on Women Veterans, Notice of Meeting | |
| 83 FR 59412 - Gateway National Recreation Area Fort Hancock 21st Century Advisory Committee Notice of Public Meeting | |
| 83 FR 59412 - Na Hoa Pili O Kaloko-Honokohau National Historical Park Advisory Commission Notice of Public Meeting | |
| 83 FR 59363 - Grant of Interim Extension of the Term of U.S. Patent No. 8,311,629; OPTIMIZER® Smart Implantable Pulse Generator | |
| 83 FR 59343 - Estate and Gift Taxes; Difference in the Basic Exclusion Amount | |
| 83 FR 59364 - Grant of Interim Extension of the Term of U.S. Patent No. 8,260,416; OPTIMIZER® Smart Implantable Pulse Generator | |
| 83 FR 59312 - Safety Zones; Pipeline Construction, Tennessee River Miles 465 to 466, Chattanooga, TN | |
| 83 FR 59370 - Proposed Collection; Comment Request | |
| 83 FR 59353 - Pilot Program for Collaborative Research on Motor Vehicles With High or Full Driving Automation; Extension of Comment Period | |
| 83 FR 59399 - Georgia; Amendment No. 6 to Notice of a Major Disaster Declaration | |
| 83 FR 59442 - Tulsa-Sapulpa Union Railway Company, L.L.C.-Lease Renewal Exemption With Interchange Commitment-Union Pacific Railroad Company | |
| 83 FR 59397 - Georgia; Amendment No. 5 to Notice of a Major Disaster Declaration | |
| 83 FR 59371 - International Energy Agency Meetings | |
| 83 FR 59398 - Proposed Flood Hazard Determinations | |
| 83 FR 59403 - Notice of the President's National Infrastructure Advisory Council Meeting | |
| 83 FR 59269 - Rural Development Environmental Regulation for Rural Infrastructure Projects | |
| 83 FR 59318 - Rural Development Environmental Regulation for Rural Infrastructure Projects | |
| 83 FR 59363 - Nominations to the Marine Fisheries Advisory Committee | |
| 83 FR 59382 - Agency Information Collection Activities: Proposed Collection Renewal; Comment Request (OMB No. 3064-0093) | |
| 83 FR 59440 - Data Collection Available for Public Comments | |
| 83 FR 59358 - Foreign-Trade Zone (FTZ) 87-Lake Charles, Louisiana, Notification of Proposed Production Activity, Driftwood LNG, LLC (Liquified Natural Gas Processing), Sulphur, Louisiana | |
| 83 FR 59358 - Foreign-Trade Zone (FTZ) 18-San Jose, California; Notification of Proposed Production Activity; Bloom Energy Corporation (Commercial Fuel Cells and Related Subassemblies), Sunnyvale and Mountain View, California | |
| 83 FR 59360 - Certain Oil Country Tubular Goods From India: Notice of Correction to the Amended Final Determination and Amendment of the Antidumping Duty Order | |
| 83 FR 59441 - Data Collection Available for Public Comments | |
| 83 FR 59444 - Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders | |
| 83 FR 59411 - Notice of Availability of Draft Environmental Impact Statement for the Proposed Dairy Syncline Mine and Reclamation Plan, Caribou County, Idaho | |
| 83 FR 59447 - Advisory Committee on Aviation Consumer Protection Matters; Subcommittee on In-Flight Sexual Misconduct | |
| 83 FR 59449 - Advisory Committee on the Readjustment of Veterans; Notice of Meeting | |
| 83 FR 59369 - Submission for OMB Review; Comment Request | |
| 83 FR 59363 - Fisheries of the Northeastern United States; Atlantic Surfclam and Ocean Quahog Fisheries; Notice That Vendor Will Provide 2019 Cage Tags | |
| 83 FR 59364 - Army Education Advisory Subcommittee Meeting Notice | |
| 83 FR 59365 - Expeditionary Technology Search (xTechSearch) II Prize Competition Announcement | |
| 83 FR 59378 - Environmental Impact Statements; Notice of Availability | |
| 83 FR 59303 - DoD Identity Management | |
| 83 FR 59354 - Submission for OMB Review; Comment Request | |
| 83 FR 59414 - Agency Information Collection Activities; Diversions, Return Flow, and Consumptive Use of Colorado River Water in the Lower Colorado River Basin | |
| 83 FR 59357 - Notice of Intent To Request To Conduct a New Information Collection | |
| 83 FR 59354 - Agency Information Collection Activities: Extension of Approved Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery | |
| 83 FR 59439 - Proposed Collection; Comment Request | |
| 83 FR 59431 - Proposed Collection; Comment Request | |
| 83 FR 59432 - Submission for OMB Review; Comment Request | |
| 83 FR 59448 - Notice of OFAC Sanctions Action | |
| 83 FR 59362 - Submission for OMB Review; Comment Request | |
| 83 FR 59409 - Proposed Finding Against Federal Acknowledgment of the Southern Sierra Miwuk Nation | |
| 83 FR 59315 - Approval and Promulgation of Air Quality Implementation Plans; State of Utah; Logan Nonattainment Area Fine Particulate Matter State Implementation Plan for Attainment of 2006 24-Hour Fine Particulate Matter National Ambient Air Quality Standards | |
| 83 FR 59371 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; International Resource Information System (IRIS) | |
| 83 FR 59446 - Hazardous Materials: Information Collection Activities | |
| 83 FR 59425 - New Postal Products | |
| 83 FR 59408 - Agency Information Collection Activities; Human Capital Management Strengths and Needs Assessment | |
| 83 FR 59392 - Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0044 | |
| 83 FR 59386 - Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher | |
| 83 FR 59380 - Agency Information Collection Activities: Submission for OMB Review; Comment Request (OMB No. 3064-0072) | |
| 83 FR 59350 - Air Quality Designation for the 2010 Sulfur Dioxide (SO2 | |
| 83 FR 59356 - Submission for OMB Review; Comment Request | |
| 83 FR 59370 - Submission for OMB Review; Comment Request | |
| 83 FR 59375 - Notice of Availability of the Draft Environmental Impact Statement for the Proposed Gulf LNG Liquefaction Project: Gulf LNG Liquefaction Company, LLC; Gulf LNG Energy, LLC; Gulf LNG Pipeline, LLC | |
| 83 FR 59373 - City of Woonsocket; Notice of Application Tendered for Filing With the Commission and Soliciting Additional Study Requests and Establishing Procedural Schedule for Relicensing and a Deadline for Submission of Final Amendments | |
| 83 FR 59432 - In the Matter of the BOX Exchange LLC Regarding a Suspension of and Order Instituting Proceedings To Determine Whether To Approve or Disapprove a Proposed Rule Change To Amend the Fee Schedule on the BOX Market LLC Options Facility To Establish BOX Connectivity Fees for Participants and Non-Participants Who Connect to the BOX Network (File No. SR-BOX-2018-24); Order Granting Petition for Review and Scheduling Filing of Statements | |
| 83 FR 59435 - Self-Regulatory Organizations; Miami International Securities Exchange, LLC; Notice of Filing of a Proposed Rule Change To Amend Exchange Rule 518, Complex Orders | |
| 83 FR 59429 - Self-Regulatory Organizations; BOX Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Permit Up to Ten Expiration Months for Long-Term Options on the SPDR® S&P® 500 Exchange-Traded Fund Shares (“SPY”) | |
| 83 FR 59427 - Self-Regulatory Organizations; National Securities Clearing Corporation; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Enhance the Mutual Fund Profile Service To Provide for the Transmission of Event Notifications Through a New Feature Called MF Info Xchange | |
| 83 FR 59433 - Self-Regulatory Organizations; Nasdaq PHLX LLC; Order Approving a Proposed Rule Change To Amend Rules 1000, 1064, and 1069 To Allow for the Snapshot Functionality of the Floor-Based Management System To Be Used for All Orders | |
| 83 FR 59367 - Submission for OMB Review; Comment Request | |
| 83 FR 59374 - City of Radford; Notice of Availability of Environmental Assessment | |
| 83 FR 59373 - CITGO Petroleum Corporation v. Colonial Pipeline Company; Notice of Complaint | |
| 83 FR 59415 - Certain Two-Way Radio Equipment and Systems, Related Software and Components Thereof; Commission Decision To Affirm-in-Part, Modify-in-Part, Reverse-in-Part, and Strike Certain Portions of a Final Initial Determination Finding a Violation of Section 337; Issuance of Limited Exclusion Order and Cease and Desist Orders; and Termination of the Investigation | |
| 83 FR 59356 - Notice of Request for an Extension of Approval of an Information Collection; Nomination Request Form; Animal Disease Training | |
| 83 FR 60306 - United States v. GS Caltex Corp. et al.; Proposed Final Judgments and Competitive Impact Statement | |
| 83 FR 59368 - Submission for OMB Review; Comment Request | |
| 83 FR 59448 - Publication of the Tier 2 Tax Rates | |
| 83 FR 59366 - Submission for OMB Review; Comment Request | |
| 83 FR 59418 - Notice of the Federal Unemployment Tax Act (FUTA) Credit Reduction Applicable in 2018 | |
| 83 FR 59312 - Drawbridge Operation Regulation; Three Mile Slough, Rio Vista, CA | |
| 83 FR 59406 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Policy for Evaluation of Conservation Efforts When Making Listing Decisions (PECE) | |
| 83 FR 59424 - Establishment of Atomic Safety and Licensing Board: Interim Storage Partners LLC | |
| 83 FR 59422 - Business and Operations Advisory Committee; Notice of Meeting | |
| 83 FR 59426 - Product Change-Priority Mail Express, Priority Mail, & First-Class Package Service Negotiated Service Agreement | |
| 83 FR 59426 - Product Change-Priority Mail Negotiated Service Agreement | |
| 83 FR 59434 - Proposed Collection; Comment Request | |
| 83 FR 59404 - Notice of Certain Operating Cost Adjustment Factors for 2019 | |
| 83 FR 59388 - Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria | |
| 83 FR 59368 - Proposed Collection; Comment Request | |
| 83 FR 59422 - Cost Accounting Standards Board Meeting Agenda | |
| 83 FR 59288 - Airworthiness Directives; Zodiac Seats France Cabin Attendant Seats | |
| 83 FR 59386 - Notice of Request for Information; A Notice by the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria | |
| 83 FR 59314 - Safety Zone; Lower Mississippi River, Mile Markers 94 to 95 Above Head of Passes, New Orleans, LA | |
| 83 FR 59413 - Agency Information Collection Activities; National Historic Landmarks Nomination Form | |
| 83 FR 59413 - Agency Information Collection Activities; Using Web and Mobile-Based Applications During NPS Citizen Science Events | |
| 83 FR 59426 - Transfer of Inbound Letter Post Small Packets and Bulky Letters, and Inbound Registered Service Associated With Such Items, to Competitive Product List | |
| 83 FR 59390 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting | |
| 83 FR 59389 - National Institute on Drug Abuse; Notice of Closed Meetings | |
| 83 FR 59389 - National Institute on Drug Abuse; Notice of Closed Meeting | |
| 83 FR 59383 - Agency Information Collection Activities: Proposed Collection Renewal; Comment Request (OMB No. 3064-0117; -0145; and -0152) | |
| 83 FR 59318 - Fidelity Bonds | |
| 83 FR 59272 - Appraisals for Higher-Priced Mortgage Loans Exemption Threshold | |
| 83 FR 59276 - Truth in Lending (Regulation Z) | |
| 83 FR 59274 - Consumer Leasing (Regulation M) | |
| 83 FR 59285 - Airworthiness Directives; Airbus SAS Airplanes | |
| 83 FR 59328 - Airworthiness Directives; Airbus SAS Airplanes | |
| 83 FR 59326 - Airworthiness Directives; Dassault Aviation Airplanes | |
| 83 FR 59359 - Notice of Commencement of a Compliance Proceeding Pursuant to Section 129 of the Uruguay Round Agreements Act | |
| 83 FR 59295 - Accounting and Ratemaking Treatment of Accumulated Deferred Income Taxes and Treatment Following the Sale or Retirement of an Asset | |
| 83 FR 59331 - Public Utility Transmission Rate Changes To Address Accumulated Deferred Income Taxes | |
| 83 FR 59290 - Airworthiness Directives; Zodiac Aero Evacuation Systems (also known as Air Cruisers Company) | |
| 83 FR 59278 - Airworthiness Directives; Airbus SAS Airplanes | |
| 83 FR 59836 - Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; Medicaid Promoting Interoperability Program; Quality Payment Program Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year; Provisions From the Medicare Shared Savings Program Accountable Care OrganizationsPathways to Success; and Expanding the Use of Telehealth Services for the Treatment of Opioid Use Disorder Under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act |
Animal and Plant Health Inspection Service
Farm Service Agency
Forest Service
National Agricultural Statistics Service
Rural Business-Cooperative Service
Rural Housing Service
Rural Utilities Service
Foreign-Trade Zones Board
International Trade Administration
National Oceanic and Atmospheric Administration
Patent and Trademark Office
Army Department
Navy Department
Federal Energy Regulatory Commission
Centers for Medicare & Medicaid Services
Children and Families Administration
Food and Drug Administration
National Institutes of Health
Substance Abuse and Mental Health Services Administration
Coast Guard
Federal Emergency Management Agency
Fish and Wildlife Service
Geological Survey
Indian Affairs Bureau
Land Management Bureau
National Park Service
Reclamation Bureau
Antitrust Division
Employment and Training Administration
Federal Aviation Administration
Federal Motor Carrier Safety Administration
National Highway Traffic Safety Administration
Pipeline and Hazardous Materials Safety Administration
Comptroller of the Currency
Foreign Assets Control Office
Internal Revenue Service
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
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Rural Business-Cooperative Service, Rural Housing Service, Rural Utilities Service, Farm Service Agency, USDA.
Direct final rule.
The United States Department of Agriculture (USDA) Rural Development (RD), comprised of the Rural Business-Cooperative Service (RBS), Rural Housing Service (RHS), and Rural Utilities Service (RUS), hereafter referred to as the Agency, is issuing a direct final rule to update the Agency's Environmental Policies and Procedures regulation (7 CFR 1970) to allow the Agency Administrators limited flexibility to obligate federal funds for infrastructure projects prior to completion of the environmental review while ensuring full compliance with National Environmental Policy Act (NEPA) procedures prior to project construction and disbursement of any RD funding. This change will allow RD to more fully meet the Administration's goals to speed the initiation of infrastructure projects and encourage planned community economic development without additional cost to taxpayers or change to environmental review requirements.
This rule is effective January 7, 2019, without further action, unless the Agency receives significant adverse comments or, an intent to submit a significant adverse comment, by December 24, 2018. Written significant adverse comments or, an intent to submit a significant adverse comment, must be received by Rural Development or carry a postmark or equivalent no later than December 24, 2018. If significant adverse comments are received, the Agency will publish a timely
Submit your comments on this rule by any of the following methods:
•
•
Kellie McGinness Kubena, Director, Engineering and Environmental Staff, Rural Utilities Service, USDA Rural Development, 1400 Independence Ave SW, Mail Stop 1571, Room 2242, Washington, DC 20250-1571 Phone: 202-720-1649.
This final rule has been determined to be not significant for the purposes of Executive Order 12866, Regulatory Planning and Review, and therefore has not been reviewed by the Office of Management and Budget (OMB).
This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. The Agency has determined that this rule meets the applicable standards provided in section 3 of the Executive Order. In addition, all state and local laws and regulations that are in conflict with this rule will be preempted. No retroactive effect will be given to this rule and, in accordance with section 212(e) of the Department of Agriculture Reorganization Act of 1994 (7 U.S.C. 6912(e)), administrative appeal procedures must be exhausted before an action against the Department or its agencies may be initiated.
This final rule is not subject to the requirements of Executive Order 12372, “Intergovernmental Review,” as implemented under USDA's regulations at 2 CFR part 415, subpart C, because this rule provides general guidance on NEPA and related environmental reviews of applicants' proposals. Applications for Agency programs will be reviewed individually under Executive Order 12372 as required by program procedures.
The Agency has determined that this final rule will not have a significant economic impact on a substantial number of small entities, as defined in the Regulatory Flexibility Act (5 U.S.C. §§ 601
In this final rule, the Agency proposes to create limited flexibility for the timing of obligation of funds relative to the completion of environmental review. The Council on Environmental Quality (CEQ) does not direct agencies to prepare a NEPA analysis before establishing agency procedures that supplement the CEQ regulations for implementing NEPA. The requirements for establishing agency NEPA procedures are set forth at 40 CFR 1505.1 and 1507.3. The determination that establishing agency NEPA
The Catalog of Federal Domestic Assistance (CFDA) numbers assigned to the RD Programs affected by this rulemaking are as follows:
All active CFDA programs can be found at
Rural Development infrastructure programs not listed in this section nor on the CFDA website, but which are enacted pursuant to the Rural Electrification Act of 1936, 7 U.S.C. 901
This final rule contains no Federal mandates (under the regulatory provisions of Title II of the Unfunded Mandates Reform Act of 1995) for state, local, and tribal governments or the private sector. Therefore, this rule is not subject to the requirements of §§ 202 and 205 of the Unfunded Mandates Reform Act of 1995.
The Agency is committed to the E-Government Act, which requires Government agencies in general to provide the public the option of submitting information or transacting business electronically to the maximum extent possible.
The policies contained in this final rule do not have any substantial direct effect on states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. Nor does this final rule impose substantial direct compliance costs on state and local governments. Therefore, consultation with the states is not required.
This rule has been reviewed in accordance with the requirements of Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments.” Executive Order 13175 requires Federal agencies to consult and coordinate with tribes on a government-to-government basis on policies that have tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that 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 latest revision of the Agency's Environmental Policies and Procedures in 2016 involved Tribal consultation via comment period and webinar as a baseline for future consultation on individual program actions. The creation of limited flexibility for the timing of obligation of funds relative to the completion of environmental review is only an administrative, procedural change on the government's part and in no way abridges or alters that agreement. Therefore, no further consultation is necessary on this rule change. The policies contained in this final rule do not have Tribal implications that preempt Tribal law. The Agency will continue to work directly with Tribes and Tribal applicants to improve access to Agency programs. This includes providing focused outreach to Tribes regarding implementation of this rule change. Additionally, the Agency will respond in a timely and meaningful manner to all Tribal government requests for consultation concerning this rule. For further information on the Agency's Tribal consultation efforts, please contact Rural Development's Native American Coordinator at (720) 544-2911 or
In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, the USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.
Persons with disabilities who require alternative means of communication for program information (
To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at
USDA is an equal opportunity provider, employer, and lender.
In accordance with the Paperwork Reduction Act, the paperwork burden associated with this final rule has been approved by the Office of Management and Budget (OMB) under the currently approved OMB Control Number 0575-0197. The Agency has determined that changes contained in this regulatory action do not substantially change current data collection that would require approval under the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).
The United States Department of Agriculture (USDA) Rural Development (RD) programs provide loans, grants and loan guarantees to support investment in rural infrastructure to spur rural economic development, create jobs, improve the quality of life, and address the health and safety needs of rural residents. Infrastructure investment is an important national policy priority. As directed by E.O. 13807 in 2017, USDA as a member of the Federal Permitting Improvement Steering Council has reviewed its NEPA implementing regulations and policies to identify impediments to efficient and effective environmental reviews and authorizations for infrastructure projects. This final rule is part of that effort to improve the efficiency and effectiveness of RD's environmental reviews and authorizations for infrastructure projects in rural America.
On April 25, 2017, the President created the Interagency Task Force on Agriculture and Rural Prosperity (Task Force) through E.O. 13790 and appointed the Secretary of Agriculture as the Task Force's Chair. Among the purposes and functions of the Task Force was to,
“. . . identify legislative, regulatory, and policy changes to promote in rural America agriculture, economic development, job growth, infrastructure improvements, technological innovation, energy security, and quality of life, including changes that remove barriers to economic prosperity and quality of life in rural America.”
This rulemaking fulfills the mandate of E.O. 13807 as well as the goals of the President's Interagency Task Force on Agriculture and Rural Prosperity by identifying regulatory changes that promote economic development and improve the quality of life in rural America. The RD infrastructure projects impacted by this rule are often critical to the health and safety and quality of life in rural communities. In some cases, funding decisions made by Rural Development are the first step upon which a much larger process of community economic development depends. This amendment to existing regulation will allow the Agency to obligate funding
Nothing in this final rule reduces RD's obligation to complete the NEPA planning process prior to foreclosing reasonable alternatives to the federal action. The current regulation at 7 CFR 1970.6 (“Financial assistance”) states that the Agency defines the major decision point for completion of NEPA as the approval of financial assistance. Similarly, 7 CFR 1970.11(b) identifies Agency obligation as the point by which the environmental review must be concluded. As amended by this final rule, 7 CFR 1970.11(b) will now provide RD Administrators limited flexibility to obligate funds for infrastructure projects prior to the completion of the environmental review process where the assurance that funds will be available is important for community health, safety, or economic development. As a result, the environmental review process must be completed prior to disbursement of any RD funds, or any other action that would have adverse environmental impact or limit the choice of reasonable alternatives. The conditions of obligation will be defined in the documentation of the agreement approving the financial assistance between the Agency and the applicant. If, however, the conditions of obligation are not met, or the agency chooses not to proceed with the project after considering the results of the NEPA process, the Agency will rescind the obligated funds. With these conditions, the Agency retains control of the final decision to authorize construction and release funds based on the satisfactory completion of the environmental review. Note, this final rule will not, and does not, change any of the requirements for environmental reviews. Should an applicant choose to commence a project and thus foreclose reasonable alternatives, such action would result in de-obligation of federal funding, thereby eliminating any federal action for NEPA purposes on the part of Rural Development. Until the Agency concludes the environmental review and decides to proceed with the project, the obligated funds will be reserved for the infrastructure project and less susceptible to Congressional rescission.
Administrative practice and procedure, Buildings and facilities, Environmental impact statements, Environmental protection, Grant programs, Housing, Loan programs, Natural resources, Utilities.
Accordingly, for reasons set forth in the preamble, chapter XVII, of subtitle B, title 7, Code of Federal Regulations is amended as follows:
7 U.S.C. 6941
(b) The environmental review process must be concluded before the obligation of funds; except for infrastructure projects where the assurance that funds will be available for community health, safety, or economic development has been determined as necessary by the Agency Administrator. At the discretion of the Agency Administrator, funds may be obligated contingent upon the conclusion of the environmental review process prior to any action that would have an adverse effect on the environment or limit the choices of any reasonable alternatives. Funds so obligated shall be rescinded if the Agency cannot conclude the environmental review process before the end of the fiscal year after the year in which the funds were obligated, or if the Agency determines that it cannot proceed with approval based on findings in the environmental review process. For the purposes of this section, infrastructure projects shall include projects such as broadband, telecommunications, electric, energy efficiency, smart grid, water, sewer, transportation, and energy capital investments in physical plant and equipment, but not investments authorized in the Housing Act of 1949.
Office of the Comptroller of the Currency, Treasury (OCC), Board of Governors of the Federal Reserve System (Board); and Bureau of Consumer Financial Protection (Bureau).
Final rules, official interpretations and commentary.
The OCC, the Board, and the Bureau are finalizing amendments to the official interpretations for their regulations that implement section 129H of the Truth in Lending Act (TILA). Section 129H of TILA establishes special appraisal requirements for “higher-risk mortgages,” termed “higher-priced mortgage loans” or “HPMLs” in the agencies' regulations. The OCC, the Board, the Bureau, the Federal Deposit Insurance Corporation (FDIC), the National Credit Union Administration (NCUA), and the Federal Housing Finance Agency (FHFA) (collectively, the Agencies) issued joint final rules implementing these requirements, effective January 18, 2014. The Agencies' rules exempted, among other loan types, transactions of $25,000 or less, and required that this loan amount be adjusted annually based on any annual percentage increase in the Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W). If there is no annual percentage increase in the CPI-W, the OCC, the Board, and the Bureau will not adjust this exemption threshold from the prior year. However, in years following a year in which the exemption threshold was not adjusted, the threshold is calculated by applying the annual percentage increase in the CPI-W to the dollar amount that would have resulted, after rounding, if the decreases and any subsequent increases in the CPI-W had been taken into account. Based on the CPI-W in effect as of June 1, 2018, the exemption threshold will increase from $26,000 to $26,700, effective January 1, 2019.
This final rule is effective January 1, 2019.
The Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 (Dodd-Frank Act) amended the Truth in Lending Act (TILA) to add special appraisal requirements for “higher-risk mortgages.”
The OCC's, the Board's, and the Bureau's versions of the January 2013 Final Rule and December 2013 Supplemental Final Rule and corresponding official interpretations are substantively identical. The FDIC, NCUA, and FHFA adopted the Bureau's version of the regulations under the
The OCC's, Board's, and Bureau's regulations,
On November 30, 2016, the OCC, the Board, and the Bureau published a final rule in the
Effective January 1, 2019, the exemption threshold amount is increased from $26,000 to $26,700. This is based on the CPI-W in effect on June 1, 2018, which was reported on May 10, 2018. The Bureau of Labor Statistics publishes consumer-based indices monthly, but does not report a CPI change on June 1; adjustments are reported in the middle of the prior month. The CPI-W is a subset of the CPI-U index (based on all urban consumers) and represents approximately 29 percent of the U.S. population. The CPI-W reported on May 10, 2018, reflects a 2.6 percent increase in the CPI-W from April 2017 to April 2018. Accordingly, the 2.6 percent increase in the CPI-W from April 2017 to April 2018 results in an exemption threshold amount of $26,700. The OCC, the Board, and the Bureau are revising the commentaries to their respective regulations to add new comments as follows:
• Comment 203(b)(2)-3.vi to 12 CFR part 34, Appendix C to Subpart G (OCC);
• Comment 43(b)(2)-3.vi to Supplement I of 12 CFR part 226 (Board); and
• Comment 35(c)(2)(ii)-3.vi to Supplement I of 12 CFR part 1026 (Bureau).
These new comments state that, from January 1, 2019, through December 31, 2019, the threshold amount is $26,700. These revisions are effective January 1, 2019.
Under the Administrative Procedure Act, notice and opportunity for public comment are not required if an agency finds that notice and public comment are impracticable, unnecessary, or contrary to the public interest.
The Regulatory Flexibility Act (RFA) does not apply to a rulemaking where a general notice of proposed rulemaking is not required.
In accordance with the Paperwork Reduction Act of 1995,
The OCC analyzes proposed rules for the factors listed in Section 202 of the Unfunded Mandates Reform Act of 1995, before promulgating a final rule for which a general notice of proposed rulemaking was published.
Pursuant to the Congressional Review Act (5 U.S.C. 801
Appraisal, Appraiser, Banks, Banking, Consumer protection, Credit, Mortgages, National banks, Reporting and recordkeeping requirements, Savings associations, Truth in lending.
Advertising, Appraisal, Appraiser, Consumer protection, Credit, Federal Reserve System, Mortgages, Reporting and recordkeeping requirements, Truth in lending.
Advertising, Appraisal, Appraiser, Banking, Banks, Consumer protection, Credit, Credit unions, Mortgages, National banks, Reporting and recordkeeping requirements, Savings associations, Truth in lending.
For the reasons set forth in the preamble, the OCC amends 12 CFR part 34 as set forth below:
12 U.S.C. 1
3. * * *
vi. From January 1, 2019, through December 31, 2019, the threshold amount is $26,700.
For the reasons set forth in the preamble, the Board amends Regulation Z, 12 CFR part 226, as set forth below:
12 U.S.C. 3806; 15 U.S.C. 1604, 1637(c)(5), 1639(l), and 1639h; Pub. L. 111-24, section 2, 123 Stat. 1734; Pub. L. 111-203, 124 Stat. 1376.
Section 226.43—Appraisals for Higher-Risk Mortgage Loans
3. * * *
vi. From January 1, 2019, through December 31, 2019, the threshold amount is $26,700.
For the reasons set forth in the preamble, the Bureau amends Regulation Z, 12 CFR part 1026, as set forth below:
12 U.S.C. 2601, 2603-2605, 2607, 2609, 2617, 3353, 5511, 5512, 5532, 5581; 15 U.S.C. 1601
3. * * *
vi. From January 1, 2019, through December 31, 2019, the threshold amount is $26,700.
Board of Governors of the Federal Reserve System (Board); and Bureau of Consumer Financial Protection (Bureau).
Final rules, official interpretations and commentary.
The Board and the Bureau are finalizing amendments to the official interpretations and commentary for the agencies' regulations that implement the Consumer Leasing Act (CLA). The Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) amended the CLA by requiring that the dollar threshold for exempt consumer leases be adjusted annually by the annual percentage increase in the Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W). If there is no annual percentage increase in the CPI-W, the Board and the Bureau will not adjust this exemption threshold from the prior year. However, in years following a year in which the exemption threshold was not adjusted, the threshold is calculated by applying the annual percentage change in the CPI-W to the dollar amount that would have resulted, after rounding, if the decreases and any subsequent increases in the CPI-W had been taken into account. Based on the annual percentage increase in the CPI-W as of June 1, 2018, the exemption threshold will increase from $55,800 to $57,200 effective January 1, 2019.
Because the Dodd-Frank Act also requires similar adjustments in the Truth in Lending Act's threshold for exempt consumer credit transactions, the Board and the Bureau are making similar amendments to each of their respective regulations implementing the Truth in Lending Act elsewhere in this issue of the
This final rule is effective January 1, 2019.
The Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 (Dodd-Frank Act) increased the threshold in the Consumer Leasing Act (CLA) for exempt consumer leases, and the threshold in the Truth in Lending Act (TILA) for exempt consumer credit transactions,
Title X of the Dodd-Frank Act transferred rulemaking authority for a number of consumer financial protection laws from the Board to the Bureau, effective July 21, 2011. In connection with this transfer of rulemaking authority, the Bureau issued its own Regulation M implementing the CLA, 12 CFR part 1013, substantially duplicating the Board's Regulation M.
The Board's and the Bureau's regulations,
On November 30, 2016, the Board and the Bureau published a final rule in the
Effective January 1, 2019, the exemption threshold amount is increased from $55,800 to $57,200. This is based on the CPI-W in effect on June 1, 2018, which was reported on May 10, 2018. The Bureau of Labor Statistics publishes consumer-based indices monthly, but does not report a CPI change on June 1; adjustments are reported in the middle of the prior month. The CPI-W is a subset of the CPI-U index (based on all urban consumers) and represents approximately 29 percent of the U.S. population. The CPI-W reported on May 10, 2018 reflects a 2.6 percent increase in the CPI-W from April 2017 to April 2018. Accordingly, the 2.6 percent increase in the CPI-W from April 2017 to April 2018 results in an exemption threshold amount of $57,200. The Board and the Bureau are revising the commentaries to their respective regulations to add new comment 2(e)-11.x to state that, from January 1, 2019 through December 31, 2019, the threshold amount is $57,200. These revisions are effective January 1, 2019.
Under the Administrative Procedure Act, notice and opportunity for public comment are not required if the Board and the Bureau find that notice and public comment are impracticable, unnecessary, or contrary to the public interest.
The Regulatory Flexibility Act (RFA) does not apply to a rulemaking where a general notice of proposed rulemaking is not required.
In accordance with the Paperwork Reduction Act of 1995,
Pursuant to the Congressional Review Act (5 U.S.C. 801
Advertising, Consumer leasing, Consumer protection, Federal Reserve System, Reporting and recordkeeping requirements.
Advertising, Consumer leasing, Reporting and recordkeeping requirements, Truth in lending.
For the reasons set forth in the preamble, the Board amends Regulation M, 12 CFR part 213, as set forth below:
15 U.S.C. 1604 and 1667f; Pub. L. 111-203 section 1100E, 124 Stat. 1376.
11. * * *
x. From January 1, 2019 through December 31, 2019, the threshold amount is $57,200.
For the reasons set forth in the preamble, the Bureau amends Regulation M, 12 CFR part 1013, as set forth below:
15 U.S.C. 1604 and 1667f; Pub. L. 111-203 section 1100E, 124 Stat. 1376.
11. * * *
x. From January 1, 2019 through December 31, 2019, the threshold amount is $57,200.
Board of Governors of the Federal Reserve System (Board); and Bureau of Consumer Financial Protection (Bureau).
Final rules, official interpretations and commentary.
The Board and the Bureau are publishing final rules amending the official interpretations and commentary for the agencies' regulations that implement the Truth in Lending Act (TILA). The Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) amended TILA by requiring that the dollar threshold for exempt consumer credit transactions be adjusted annually by the annual percentage increase in the Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W). If there is no annual percentage increase in the CPI-W, the Board and the Bureau will not adjust this exemption threshold from the prior year. However, in years following a year in which the exemption threshold was not adjusted, the threshold is calculated by applying the annual percentage change in the CPI-W to the dollar amount that would have resulted, after rounding, if the decreases and any subsequent increases in the CPI-W had been taken into account.
Because the Dodd-Frank Act also requires similar adjustments in the Consumer Leasing Act's threshold for exempt consumer leases, the Board and the Bureau are making similar amendments to each of their respective regulations implementing the Consumer Leasing Act elsewhere in this issue of the
This final rule is effective January 1, 2019.
The Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 (Dodd-Frank Act) increased the threshold in the Truth in Lending Act (TILA) for exempt consumer credit transactions,
Title X of the Dodd-Frank Act transferred rulemaking authority for a number of consumer financial protection laws from the Board to the Bureau, effective July 21, 2011. In connection with this transfer of rulemaking authority, the Bureau issued its own Regulation Z implementing TILA, 12 CFR part 1026, substantially duplicating the Board's Regulation Z.
The Board's and the Bureau's regulations,
On November 30, 2016, the Board and the Bureau published a final rule in the
Effective January 1, 2019, the exemption threshold amount is increased from $55,800 to $57,200. This is based on the CPI-W in effect on June 1, 2018, which was reported on May 10, 2018. The Bureau of Labor Statistics publishes consumer-based indices monthly, but does not report a CPI change on June 1; adjustments are reported in the middle of the prior month. The CPI-W is a subset of the CPI-U index (based on all urban consumers) and represents approximately 29 percent of the U.S. population. The CPI-W reported on May 10, 2018 reflects a 2.6 percent increase in the CPI-W from April 2017 to April 2018. Accordingly, the 2.6 percent increase in the CPI-W from April 2017 to April 2018 results in an exemption threshold amount of $57,200. The Board and the Bureau are revising the commentaries to their respective regulations to add new comment 3(b)-
Under the Administrative Procedure Act, notice and opportunity for public comment are not required if the Board and the Bureau find that notice and public comment are impracticable, unnecessary, or contrary to the public interest.
The Regulatory Flexibility Act (RFA) does not apply to a rulemaking where a general notice of proposed rulemaking is not required.
In accordance with the Paperwork Reduction Act of 1995,
Pursuant to the Congressional Review Act (5 U.S.C. 801
Advertising, Consumer protection, Federal Reserve System, Reporting and recordkeeping requirements, Truth in lending.
Advertising, Appraisal, Appraiser, Banking, Banks, Consumer protection, Credit, Credit unions, Mortgages, National banks, Reporting and recordkeeping requirements, Savings associations, Truth in lending.
For the reasons set forth in the preamble, the Board amends Regulation Z, 12 CFR part 226, as set forth below:
12 U.S.C. 3806; 15 U.S.C. 1604, 1637(c)(5), 1639(l) and 1639h; Pub. L. 111-24, section 2, 123 Stat. 1734; Pub. L. 111-203, 124 Stat. 1376.
3. * * *
x. From January 1, 2019 through December 31, 2019, the threshold amount is $57,200.
For the reasons set forth in the preamble, the Bureau amends Regulation Z, 12 CFR part 1026, as set forth below:
12 U.S.C. 2601, 2603-2605, 2607, 2609, 2617, 3353, 5511, 5512, 5532, 5581; 15 U.S.C. 1601
3. * * *
x. From January 1, 2019 through December 31, 2019, the threshold amount is $57,200.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are adopting a new airworthiness directive (AD) for all Airbus SAS Model A318 and A319 series airplanes; Model A320-211, A320-212, A320-214, A320-216, A320-231, A320-232, and A320-233 airplanes; and Model A321-111, A321-112, A321-131, A321-211, A321-212, A321-213, A321-231, and A321-232 airplanes. This AD was prompted by reports of missing assembly hardware on the trimmable horizontal stabilizer actuator (THSA). This AD requires repetitive inspections and checks of the lower and upper THSA attachments and applicable related investigative and corrective actions; a one-time inspection of the THSA lower attachment and
This AD is effective December 28, 2018.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of December 28, 2018.
For Airbus SAS service information identified in this final rule, contact Airbus SAS, Airworthiness Office—EIAS, Rond-Point Emile Dewoitine No: 2, 31700 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
For United Technologies Corporation Aerospace Systems (UTAS) service information identified in this AD, contact United Technologies Corporation Aerospace Systems (UTAS): Goodrich Corporation, Actuation Systems, Stafford Road, Fordhouses, Wolverhampton WV10 7EH, England; phone: +44 (0) 1902 624938; fax: +44 (0) 1902 788100; email:
You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195. It is also available on the internet at
You may examine the AD docket on the internet at
Sanjay Ralhan, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3223.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Airbus SAS Model A318 and A319 series airplanes; Model A320-211, A320-212, A320-214, A320-216, A320-231, A320-232, and A320-233 airplanes; and Model A321-111, A321-112, A321-131, A321-211, A321-212, A321-213, A321-231, and A321-232 airplanes. The NPRM published in the
We are issuing this AD to address uncontrolled movement of the horizontal stabilizer as a result of the latent (undetected) failure of the THSA's primary load path and consequent loss of control of the airplane.
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2017-0237, dated December 4, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus SAS Model A318 and A319 series airplanes; Model A320-211, A320-212, A320-214, A320-216, A320-231, A320-232, A320-233 airplanes; and Model A321-111, A321-112, A321-131, A321-211, A321-212, A321-213, A321-231, and A321-232 airplanes. The MCAI states:
The Trimmable Horizontal Stabilizer Actuator (THSA) of Airbus A320 Family aeroplanes has been rig-tested to check secondary load path behaviour in case of primary load path failure. In that configuration, the loads are transferred to the secondary load path, which should jam, preventing any Trimmable Horizontal Stabilizer motion. The test results showed that the secondary load path did not jam as expected, preventing detection of the primary load path failure. To verify the integrity of the THSA primary load path and the correct installation of the THSA, Airbus issued Service Bulletin (SB) A320-27-1164, later revised multiple times, and SB A320-27A1179, and EASA issued AD 2006-0223 [which corresponds to FAA AD 2007-06-02, Amendment 39-14983 (72 FR 12072, March 15, 2007) (“AD 2007-06-02”)], AD 2007-0178 [which corresponds to FAA AD 2008-09-16, Amendment 39-15497 (73 FR 24160, May 2, 2008)(“AD 2008-09-16”)], AD 2008-0150, and AD 2014-0147, each AD superseding the previous one, requiring one-time and repetitive inspections.
Since EASA AD 2014-0147 was issued, Airbus designed a new device, called Electrical Load Sensing Device (ELSD), to introduce a new means of THSA upper secondary load path engagement detection. Consequently, Airbus issued several SBs (Airbus SB A320-27-1245, A320-27-1246, and A320-27-1247, depending on aeroplane configuration) providing instructions to install the wiring provision for ELSD installation and to install ELSD on the THSA, and SB A320-27-1248, providing instructions to activate the ELSD. Airbus also revised SB A320-27-1164, now at Revision 13, including instructions applicable for aircraft equipped with ELSD.
Furthermore, following a visual inspection of the THSA, an operator reported that the THSA was found with a bush missing, inducing torqueing of the THSA lower attachment primary bolt against the THSA lug, which resulted in the application of a transverse force on the lug.
Prompted by several other identical findings, Airbus released Alert Operator Transmission (AOT) A27N010-17 to provide instructions for inspection and associated corrective actions.
For the reasons described above, this AD retains the requirements of EASA AD 2014-0147, which is superseded, and requires installation of ELSD on the THSA, ELSD activation, and a one-time inspection to verify the bush presence on the THSA lower attachment.
The unsafe condition is uncontrolled movement of the horizontal stabilizer as a result of the latent (undetected) failure of the THSA's primary load path and consequent loss of control of the airplane.
The required actions include repetitive inspections and checks of the lower and upper THSA attachments and applicable related investigative and corrective actions; a one-time inspection of the THSA lower attachment and replacement as applicable; and, for certain airplanes, activation of the ELSD and concurrent modifications.
Related investigative actions include an inspection of the upper THSA attachment, an inspection of the lower attachment, and a check of the upper and lower clearance between the secondary nut trunnion and the junction plate. Corrective actions include replacement of the THSA and repair.
You may examine the MCAI in the AD docket on the internet at
We gave the public the opportunity to participate in developing this final rule. The following presents the comments received on the NPRM and the FAA's response to each comment.
The Air Line Pilots Association, International, stated its support for the NPRM. United Airlines stated that it has no objection to the NPRM.
Delta Air Lines (DAL) requested that the proposed AD allow operators the opportunity to utilize the latest data and instructions available without the need to request an alternative method of compliance (AMOC). DAL proposed that after each reference made to service information in paragraphs (g), (h), (i), (j), (k), (m)(1), and (m)(2) of the proposed AD, the following statement is included:
DAL noted that the service information has been revised multiple times or has been revised within a short period of time. DAL observed that the statement quoted above is based on language used in paragraph (g) of AD 2018-03-12, Amendment 39-19185 (83 FR 5906, February 12, 2018) (“AD 2018-03-12”), and should be considered as standard wording for future ADs, as applicable.
We disagree with the commenter's request. We infer that the commenter is requesting a way for operators to comply with the requirements of an AD by using service information revisions that are issued after an AD is published without having to request an AMOC. We may not refer to any document that does not yet exist. In general terms, we are required by Office of the Federal Register (OFR) regulations for approval of materials “incorporated by reference,” as specified in 1 CFR 51.1(f), to either publish the service document contents as part of the actual AD language; or submit the service document to the OFR for approval as “referenced” material, in which case we may only refer to such material in the text of an AD. The AD may refer to the service document only if the OFR approved it for “incorporation by reference.” See 1 CFR part 51. To allow operators to use later revisions of the referenced document (issued after publication of the AD), either we must revise the AD to reference specific later revisions, or operators must request approval to use later revisions as an AMOC with this AD. However, we may consider approving global AMOCs to allow operators to use future revisions of the service information. We reserve the use of the wording requested by the commenter for situations where no service information is available or a service document, such as an aircraft maintenance manual, cannot be incorporated by reference in an AD. Therefore, we have not changed this AD in this regard.
DAL requested that paragraph (k) of the proposed AD specify only paragraphs 4.2.2 and 4.2.3 of Airbus Alert Operators Transmission (AOT) A27N010-17, Revision 01, dated October 17, 2017, including AOT Appendix_A27N010-17, because, as a whole, the service information contains data that are unrelated to the inspection process. Paragraphs 4.2.2 and 4.2.3 of the service information provide the inspection activities and corrective actions.
We agree with the commenter that the primary instructions for inspection and corrective actions are contained in paragraphs 4.2.2 and 4.2.3 of Airbus AOT A27N010-17, Revision 01, dated October 17, 2017, including AOT Appendix_A27N010-17. We have revised paragraph (k) of this AD to require only paragraphs 4.2.2 and 4.2.3 of Airbus AOT A27N010-17, Revision 01, dated October 17, 2017, including AOT Appendix_A27N010-17. Note that there is relevant information outside of those two paragraphs, such as references to part numbers, aircraft maintenance manual procedures, and an appendix. Procedures outside of paragraphs 4.2.2 and 4.2.3 can be deviated from, using accepted methods provided in an operator's maintenance or inspection program, provided the required AD actions can be done and the airplane can be put back in service in an airworthy condition.
DAL noted that paragraph (o) of the proposed AD provides exceptions to two Airbus service information documents—Airbus Service Bulletin A320-27-1164, Revision 13, dated August 8, 2016; and Airbus AOT A27N010-17, Revision 01, dated October 17, 2017, including AOT Appendix_A27N010-17, with respect to contacting the manufacturer. DAL proposed that this paragraph be rewritten to state:
Any approved method which specifies to contact the manufacturer: Before further flight, accomplish the corrective actions in accordance with the procedures specified in paragraph (v)(2) of this AD.
We acknowledge the commenter's request to clarify paragraph (o) of this AD. When specifying exceptions to required service information, we are unable to generalize the required documents by stating “any approved method,” as requested by the commenter. We must identify the specific service information. Therefore, we have not changed this AD in this regard.
DAL observed that Airbus Service Bulletin A320-27-1245, Revision 00, dated March 6, 2017, indicates multiple configurations for certain aircraft. As an example, DAL pointed out that aircraft manufacturer serial number (MSN) 118 is shown as both configuration 078 and configuration 082. DAL stated the service information does not provide clear guidance on determining if both or only one set of material/instructions is applicable. DAL requested that the service bulletin be revised to clarify the intent of the multiple configurations and how to address them.
We disagree with the commenter's request to revise the service information; however, we agree to clarify. The referenced service information is adequate because different aircraft configurations can be determined based on the type of placard installed. Airbus Service Bulletin A320-27-1245, Revision 00, dated March 6, 2017, provides airplane configuration definitions in paragraph 1.A.(5), “Configuration Definition,” of the “Planning Information” section. According to the configuration definition, configuration 078 has placard 33LM PN D11311117A00 installed and configuration 082 has placard 33LM PN 002051-09 installed. Once the placard installation is determined, an operator can follow the instructions based on each respective configuration. We have not changed this AD in this regard.
DAL noted that the Model A319, A320, and A321 THSA system has had a continually complicated maintenance and regulatory history. The THSA system has been subject to numerous ADs throughout the years that address numerous individual shortcomings. The
We agree that there have been several ADs issued on the THSA system addressed in this AD, and we acknowledge the commenter's concerns. We understand that the EASA and the airplane manufacturer are making an effort to combine as many THSA issues as possible into a single rulemaking action to simplify the THSA requirements. In response to their efforts, we may consider additional rulemaking in the future to simplify the THSA requirements. However, at this time, we are issuing this final rule AD to address the specified unsafe condition. No change has been made to this AD in this regard.
Airbus noted that two of the service bulletins referred to in the NPRM were revised and requested that the revised service bulletins be referred to in the final rule. The current revision levels are Airbus Service Bulletin A320-27-1164, Revision 14, dated January 16, 2018; and Airbus Service Bulletin A320-27-1248, Revision 01, dated April 16, 2018.
We agree with the commenter's request. In the NPRM we referred to Airbus Service Bulletin A320-27-1164, Revision 13, dated August 8, 2016; and Service Bulletin A320-27-1248, Revision 00, dated March 6, 2017. Airbus Service Bulletin A320-27-1164, Revision 14, dated January 16, 2018, includes clarifications regarding reporting inspection results but does not change the proposed reporting requirements of the NPRM and otherwise adds no substantive changes compared with the previous version. Airbus Service Bulletin A320-27-1248, Revision 01, dated April 16, 2018, clarifies the instructions, but adds no substantive changes compared with the previous version. We have therefore revised the “Related Service Information under 1 CFR part 51” paragraph in this final rule to refer to Airbus Service Bulletin A320-27-1164, Revision 14, dated January 16, 2018; and Airbus Service Bulletin A320-27-1248, Revision 01, dated April 16, 2018. We have also revised paragraphs (g), (h), (i), (j), and (o)(1) of this AD to refer to Airbus Service Bulletin A320-27-1164, Revision 14, dated January 16, 2018. In addition, we revised paragraph (m) of this AD to refer to Airbus Service Bulletin A320-27-1248, Revision 01, dated April 16, 2018.
Furthermore, we revised paragraph (s), “Credit for Previous Actions,” of this AD to include Airbus Service Bulletin A320-27-1164, Revision 13, dated August 8, 2016; and Service Bulletin A320-27-1248, Revision 00, dated March 6, 2017. Specifically, we revised paragraph (s)(1) to provide credit for actions done before the effective date of this AD using Airbus Service Bulletin A320-27-1164, Revision 10, dated March 27, 2014; Revision 11, dated December 15, 2014; Revision 12, dated March 23, 2016; or Revision 13, dated August 8, 2016. We also added paragraph (s)(3) to this AD to provide credit for actions required by paragraph (m)(1) of this AD, if those actions were performed before the effective date of this AD using Airbus Service Bulletin A320-27-1248, Revision 00, dated March 6, 2017. We redesignated subsequent paragraphs of this AD accordingly.
Airbus requested that the FAA consider aligning with EASA's decision of superseding affected ADs instead of keeping the obsolete ADs active. We infer that Airbus is requesting that we supersede AD 2007-06-02 and AD 2008-09-16 instead of issuing this stand-alone AD that terminates the requirements of AD 2007-06-02 and AD 2008-09-16.
We acknowledge the commenter's request. Although paragraph (u) of this AD states “Accomplishing the initial actions required by paragraphs (g) and (h) of this AD, and accomplishing the applicable actions required by paragraphs (i) and (j) of this AD, terminates all requirements of AD 2007-06-02 and AD 2008-09-16,” it does not supersede those ADs. The purpose of issuing stand-alone AD actions is to reduce the complexity involved with superseding certain ADs. After certain compliance times in this AD have passed, we may consider rescinding AD 2007-06-02 and AD 2008-09-16 since they are terminated by certain actions in this AD. In addition, if we converted this AD to a supersedure, we would need to issue another notice for public comment, which would further delay issuance of this final rule. Therefore, we have not changed this AD in this regard.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule with the changes described previously and minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for addressing the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this final rule.
Airbus has issued Alert Operators Transmission (AOT) A27N010-17, Revision 01, dated October 17, 2017, including AOT Appendix_A27N010-17. This service information describes the procedure for a one-time general visual inspection of the THSA lower attachment to measure the gap between the THSA lower attachment tab washer and attachment plates and replacement of the THSA lower attachment if the measured gap is less than 0.5 mm. The replacement includes doing an inspection of the THSA parts to confirm the bushing is missing and applicable corrective actions (
Airbus has also issued Service Bulletin A320-27-1164, Revision 14, dated January 16, 2018. This service information describes procedures for a general visual inspection of the upper THSA attachment for correct installation, cracks, damage and metallic particles; a general visual inspection of the lower and upper THSA attachments for correct installation; a check of the clearance between secondary nut trunnions and junction plates and correct installation of the lower THSA attachment; a general visual inspection of the THSA ball screw to check for the absence of dents; and applicable related investigative and corrective actions.
In addition, Airbus has issued Service Bulletin A320-27-1245, Revision 00, dated March 6, 2017. This service information describes the procedure to modify the wiring provisions for the ELSD.
Airbus has also issued Service Bulletin A320-27-1246, Revision 01, dated November 4, 2016. This service information describes the procedures to adapt the wiring provision of the ELSD
Airbus has issued Service Bulletin A320-27-1247, Revision 00, dated March 6, 2017. This service information describes the procedure to modify the upper attachment secondary load path of the THSA to accommodate the correct installation of the ELSD.
Airbus has issued Service Bulletin A320-27-1248, Revision 01, dated April 16, 2018. This service information describes the procedure to activate the ELSD.
UTAS has issued United Technologies Corporation (UTC) Aerospace Systems Repair Instructions RF-DSC-1361-17, Version 00, including Appendix A, dated May 24, 2017. This service information describes the repair instructions to follow if the bushing is missing, as specified in AOT A27N010-17, Revision 01, dated October 17, 2017.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We estimate that this AD affects 1,180 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
We estimate the following costs to do any necessary replacements that would be required based on the results of the inspections. We have no way of determining the number of aircraft that might need this replacement:
We have received no definitive data that would enable us to provide cost estimates for the on-condition repairs specified in this AD.
A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave., SW, Washington, DC 20591, ATTN: Information Collection Clearance Officer, AES-200.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective December 28, 2018.
This AD affects AD 2007-06-02, Amendment 39-14983 (72 FR 12072, March 15, 2007) (“AD 2007-06-02”); and AD 2008-09-16, Amendment 39-15497 (73 FR 24160, May 2, 2008) (“AD 2008-09-16”).
This AD applies to Airbus SAS Model A318-111, A318-112, A318-121, and A318-122 airplanes; Model A319-111, A319-112, A319-113, A319-114, A319-115, A319-131, A319-132, and A319-133 airplanes; Model A320-211, A320-212, A320-214, A320-216, A320-231, A320-232, and A320-233 airplanes; and Model A321-111, A321-112, A321-131, A321-211, A321-212, A321-213, A321-231, and A321-232 airplanes; certificated in any category, all manufacturer serial numbers.
Air Transport Association (ATA) of America Code 27, Flight controls.
This AD was prompted by reports of missing assembly hardware on the trimmable horizontal stabilizer actuator (THSA). We are issuing this AD to address uncontrolled movement of the horizontal stabilizer as a result of the latent (undetected) failure of the THSA's primary load path and consequent loss of control of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Before exceeding 20 months since airplane first flight, or since airplane first flight following last THSA replacement, or within 20 months after the last inspection of the lower THSA attachment as specified in the instructions of Airbus Service Bulletin A320-27-1164, Revision 02 up to Revision 09, whichever occurs latest, do the actions specified in paragraphs (g)(1), (g)(2), and (g)(3) of this AD concurrently, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-27-1164, Revision 14, dated January 16, 2018. Repeat the actions thereafter at intervals not to exceed 20 months.
(1) Check the clearance between the secondary nut trunnions and the junction plates at the lower THSA attachment.
(2) Do a general visual inspection of the lower THSA attachment for correct installation of attachment parts.
(3) Do a general visual inspection of the THSA ball screw for dents.
Before exceeding 10 months since airplane first flight, or since airplane first flight following last THSA replacement, or within 10 months after the last inspection of the upper THSA attachment as specified in the instructions of Airbus Service Bulletin A320-27-1164, Revision 02 up to Revision 09, whichever occurs latest, do the actions specified in paragraphs (h)(1) and (h)(2) of this AD concurrently, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-27-1164, Revision 14, dated January 16, 2018. Repeat the inspections thereafter at intervals not to exceed 10 months.
(1) Do a general visual inspection of the upper THSA attachment for correct installation, cracks, damage, and metallic particles.
(2) Do a general visual inspection of the upper THSA attachment for correct installation of attachment parts.
If, during any action required by paragraph (g) or (h) of this AD, any discrepancy is detected (
In case of any findings during any action required by paragraph (g) or (h) of this AD, report the inspection results to Airbus SAS using the applicable “Inspection Reporting Sheet” of Airbus Service Bulletin A320-27-1164, Revision 14, dated January 16, 2018, at the applicable time specified in paragraph (j)(1) or (j)(2) of this AD. If operators have reported findings as part of obtaining any corrective actions approved by the EASA Design Organization Approval (DOA), operators are not required to report those findings as specified in this paragraph.
(1) If the inspection or check was done on or after the effective date of this AD: Submit the report within 30 days after the inspection.
(2) If the inspection or check was done before the effective date of this AD: Submit the report within 30 days after the effective date of this AD.
For airplanes on which the THSA has been replaced or reinstalled since the date of issuance of the original certificate of airworthiness, or the date of issuance of the original export certificate of airworthiness: Within 6 months after the effective date of this AD, accomplish a detailed inspection of the THSA lower attachment gap clearances, in accordance with paragraphs 4.2.2 and 4.2.3 of Airbus Alert Operators Transmission (AOT) A27N010-17, Revision 01, dated October 17, 2017, including AOT Appendix_A27N010-17. If the measured gap is less than 0.5 mm, before further flight, replace the THSA, including doing an inspection of the THSA parts to confirm the bushing is missing and applicable corrective actions, in accordance with the instructions of Airbus AOT A27N010-17, Revision 01, dated October 17, 2017, including AOT Appendix_A27N010-17; and United Technologies Corporation (UTC) Aerospace Systems Repair Instructions RF-DSC-1361-17, Version 00, including Appendix A, dated May 24, 2017, as applicable, except as required by paragraph (o)(2) of this AD.
For the purpose of this AD: Group 1 airplanes are those that, on the effective date of this AD, do not have the electrical load sensing device (ELSD) activated. Group 2 airplanes are those that, on the effective date of this AD, have the ELSD activated.
For Group 1 airplanes (see paragraph (l) of this AD): Do the actions specified in paragraphs (m)(1) and (m)(2) of this AD.
(1) Within 4 years after the effective date of this AD, activate the ELSD of the THSA on the airplane, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-27-1248, Revision 01, dated April 16, 2018.
(2) Concurrently with or before the activation of the ELSD required by paragraph (m)(1) of this AD, modify the airplane, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-27-1245, Revision 00, dated March 6, 2017; or Airbus Service Bulletin A320-27-1246, Revision 01, dated November 4, 2016; as applicable.
For an airplane equipped with a THSA having a part number listed in figure 1 to paragraphs (n), (p), and (q) of this AD: Concurrently with or before the activation required by paragraph (m)(1) of this AD, modify the airplane, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-27-1247, Revision 00, dated March 6, 2017.
(1) Where Airbus Service Bulletin A320-27-1164, Revision 14, dated January 16, 2018, specifies to contact Airbus SAS for appropriate action, and specifies that action as “RC” (Required for Compliance): Before further flight, accomplish corrective actions in accordance with the procedures specified in paragraph (v)(2) of this AD.
(2) Where Airbus AOT A27N010-17, Revision 01, dated October 17, 2017, specifies to contact Airbus SAS for appropriate action: Before further flight, accomplish corrective actions in accordance with the procedures specified in paragraph (v)(2) of this AD.
Do not install on any airplane a THSA with a part number listed in figure 1 to paragraphs (n), (p), and (q) of this AD and do not deactivate the ELSD at the times specified in paragraph (p)(1) or (p)(2) of this AD, as applicable.
(1) Group 1 airplanes (see paragraph (l) of this AD): After modification of the airplane as required by paragraph (m)(1) of this AD.
(2) Group 2 airplanes (see paragraph (l) of this AD): From the effective date of this AD.
An airplane on which Airbus SAS Modification 155955 has been embodied in production is considered compliant with paragraphs (m)(1), (m)(2), and (n) of this AD, provided that it is determined that no THSA with a part number listed in figure 1 to paragraphs (n), (p), and (q) of this AD is installed on that airplane, and that the ELSD remains activated. A review of airplane maintenance records is acceptable to make this determination, provided those records can be relied upon for that purpose.
The inspection required by paragraph (k) of this AD is not required for airplanes on which the THSA has been installed, as specified in the instructions of Airbus A320 Airplane Maintenance Manual (AMM) 27-44-51-400-001, dated May 2017, or subsequent.
(1) This paragraph provides credit for the initial actions required by paragraphs (g), (h), (i), and (j) of this AD, if those actions were performed before the effective date of this AD using Airbus Service Bulletin A320-27-1164, Revision 10, dated March 27, 2014; Revision 11, dated December 15, 2014; Revision 12, dated March 23, 2016; or Revision 13, dated August 8, 2016.
(2) This paragraph provides credit for actions required by paragraph (k) of this AD, if those actions were performed before the effective date of this AD using Airbus AOT A27N010-17, dated March 27, 2017.
(3) This paragraph provides credit for actions required by paragraph (m)(1) of this AD, if those actions were performed before the effective date of this AD using Airbus Service Bulletin A320-27-1248, Revision 00, dated March 6, 2017.
(4) This paragraph provides credit for actions required by paragraph (m)(2) of this AD, if those actions were performed before the effective date of this AD using Airbus Service Bulletin A320-27-1246, dated March 20, 2015.
Accomplishment on an airplane of the one-time inspection and replacement, as applicable, specified in paragraph (k) of this AD and the modifications specified in paragraphs (m)(1), (m)(2), and (n) of this AD, as applicable, do not constitute terminating action for the repetitive inspections required by paragraphs (g) and (h) of this AD for that airplane.
Accomplishing the initial actions required by paragraphs (g) and (h) of this AD, and accomplishing the applicable actions required by paragraphs (i) and (j) of this AD, terminate all requirements of AD 2007-06-02 and AD 2008-09-16.
The following provisions also apply to this AD:
Special flight permits, as described in Section 21.197 and Section 21.199 of the Federal Aviation Regulations (14 CFR 21.197 and 21.199), are not allowed.
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2017-0237, dated December 4, 2017, for related information. This MCAI may be found in the AD docket on the internet at
(2) For more information about this AD, contact Sanjay Ralhan, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th Street, Des Moines, WA 98198; phone and fax: 206-231-3223.
(3) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (y)(3) and (y)(5) of this AD.
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) Airbus Alert Operators Transmission (AOT) A27N010-17, Revision 01, dated October 17, 2017, including AOT Appendix_A27N010-17.
(ii) Airbus Service Bulletin A320-27-1164, Revision 14, dated January 16, 2018.
(iii) Airbus Service Bulletin A320-27-1245, Revision 00, dated March 6, 2017.
(iv) Airbus Service Bulletin A320-27-1246, Revision 01, dated November 4, 2016.
(v) Airbus Service Bulletin A320-27-1247, Revision 00, dated March 6, 2017.
(vi) Airbus Service Bulletin A320-27-1248, Revision 01, dated April 16, 2018.
(vii) United Technologies Corporation Aerospace Systems (UTAS) United Technologies Corporation (UTC) Aerospace Systems Repair Instructions RF-DSC-1361-17, Version 00, including Appendix A, dated May 24, 2017.
(3) For Airbus SAS service information identified in this AD, contact Airbus SAS, Airworthiness Office—EIAS, Rond-Point Emile Dewoitine No: 2, 31700 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
(4) For United Technologies Corporation Aerospace Systems service information identified in this AD, contact United Technologies Corporation Aerospace Systems: Goodrich Corporation, Actuation Systems, Stafford Road, Fordhouses, Wolverhampton WV10 7EH, England; phone: +44 (0) 1902 624938; fax: +44 (0) 1902 788100; email:
(5) You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.
(6) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are adopting a new airworthiness directive (AD) for all Airbus SAS Model A330-200 Freighter series airplanes, Model A330-200 and -300 series airplanes, and Model A340-200 and -300 series airplanes. This AD was prompted by defects found during production tests of ram air turbine (RAT) units; investigation revealed that the defects were due to certain RAT hydraulic pumps having an alternative manufacturing process of the pump pistons. This AD requires replacing any defective RAT hydraulic pump with a serviceable part and re-identifying the RAT module part number. We are issuing this AD to address the unsafe condition on these products.
This AD is effective December 28, 2018.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of December 28, 2018.
For Airbus SAS service information identified in this final rule, contact Airbus SAS, Airworthiness Office—EIAS, Rond-Point Emile Dewoitine No: 2, 31700 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
You may examine the AD docket on the internet at
Vladimir Ulyanov, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax: 206-231-3229.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Airbus SAS Model A330-200 Freighter series airplanes, Model A330-200 and -300 series airplanes, and Model A340-200 and -300 series airplanes. The NPRM published in the
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2018-0062, dated March 20, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus SAS Model A330-200 Freighter series airplanes, Model A330-200 and -300 series airplanes, and Model A340-200 and -300 series airplanes. The MCAI states:
Four A330 RAT units were returned to the supplier due to low discharge pressure. These defects were detected during Airbus production tests. Subsequent investigations by the RAT manufacturer UTAS (formerly Hamilton Sundstrand) revealed that some RAT hydraulic pumps, [part number] P/N 5916430, were involved in an alternative manufacturing process of the pump pistons. This resulted in form deviations (rough surface finish and sharp edges), which caused excessive wear and damage to the bore where the pistons moved.
This condition, if not corrected, could lead to low performance of the pump, possibly resulting in reduced control of the aeroplane, particularly if occurring following a total engine flame out, or during a total loss of normal electrical power generation.
To address this potential unsafe condition, Airbus published [Service Bulletin] SB A330-29-3130 and SB A340-29-4098, providing instructions for identification and replacement of the affected parts.
For the reasons described above, this [EASA] AD requires replacement of the affected parts. This [EASA] AD also requires re-identification of the RAT module.
You may examine the MCAI in the AD docket on the internet at
We gave the public the opportunity to participate in developing this final rule. We have considered the comment received. The Air Line Pilots Association, International indicated its support for the NPRM.
We received UTC Aerospace Systems Service Bulletin ERPS06M-29-22, Revision 2, dated May 24, 2018. We referred to UTC Aerospace Systems Service Bulletins ERPS06M-29-22, dated March 17, 2017; and Revision 1, dated June 27, 2017; as the appropriate sources of service information for identifying certain affected serial numbers and parts therein. Revision 2 of the service information adds Hamilton Sundstrand and Parker hydraulic pump part number (P/N) 5917648 (Parker P/N 4207905) and alternate Hamilton Sundstrand and Parker hydraulic pump P/N 5916485 (Parker P/N 4207903) to table 3 and table 6 for clarification.
We have added UTC Aerospace Systems Service Bulletin ERPS06M-29-22, Revision 2, dated May 24, 2018, to the Related Service Information under 1 CFR part 51 section of this AD as an appropriate source of service information. We have also added Revision 2 of the service information to the definitions specified in paragraph (g)(1) of this AD.
We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting this final rule with the change described previously and minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for addressing the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this final rule.
Airbus SAS has issued Service Bulletins A330-29-3130 and A340-29-4098, both dated May 3, 2017. This service information describes procedures for replacing any affected RAT hydraulic pump with a serviceable part and re-identifying the RAT module part number. These documents are distinct since they apply to different airplane models.
UTC Aerospace Systems has issued Service Bulletins ERPS06M-29-22, dated March 17, 2017; Revision 1, dated June 27, 2017; and Revision 2, dated May 24, 2018. This service information identifies affected part and serial numbers for the RAT hydraulic pump. These documents are distinct since each one applies to different hydraulic pump part numbers.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We estimate that this AD affects 103 airplanes of U.S. registry. We estimate the following costs to comply with this AD:
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective December 28, 2018.
This AD affects AD 2016-14-01, Amendment 39-18582 (81 FR 44983, July 12, 2016; corrected August 16, 2016 (81 FR 51097, August 3, 2016)) (“AD 2016-14-01”).
This AD applies to the airplanes identified in paragraphs (c)(1), (c)(2), (c)(3), (c)(4), and (c)(5) of this AD, certificated in any category, all manufacturer serial numbers.
(1) Airbus SAS Model A330-223F and -243F airplanes.
(2) Airbus SAS Model A330-201, -202, -203, -223, and -243 airplanes.
(3) Airbus SAS Model A330-301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes.
(4) Airbus SAS Model A340-211, -212, -213 airplanes.
(5) Airbus SAS Model A340-311, -312, and -313 airplanes.
Air Transport Association (ATA) of America Code 29, Hydraulic Power.
This AD was prompted by defects found during production tests of ram air turbine (RAT) units; investigation revealed that the defects were due to certain RAT hydraulic pumps having an alternative manufacturing process of the pump pistons. We are issuing this AD to prevent low performance of the pump, which, following a total engine flame-out, or during a total loss of normal electrical power generation, could result in reduced control of the airplane.
Comply with this AD within the compliance times specified, unless already done.
(1) An affected part is a RAT hydraulic pump having part number (P/N) 5916430 and a serial number identified in UTC Aerospace Systems Service Bulletin ERPS06M-29-22, dated March 17, 2017; Revision 1, dated June 27, 2017; or Revision 2, dated May 24, 2018.
(2) A serviceable part is a RAT hydraulic pump identified as acceptable in Airbus Service Bulletin A330-29-3130 or A340-29-4098, both dated May 3, 2017, as applicable.
(3) Group 1 airplanes are airplanes on which an affected part is installed.
(4) Group 2 airplanes are airplanes on which no affected part is installed. A Model A330 airplane on which Airbus SAS Modification 206604 has been embodied in production is a Group 2 airplane, provided that the airplane remains in that configuration.
(1) Within 18 months after the effective date of this AD, replace any affected RAT hydraulic pump with a serviceable part, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-29-3130 or A340-29-4098, both dated May 3, 2017, as applicable.
(2) Concurrently with the replacement required by paragraph (h)(1) of this AD, re-identify the part number of the RAT module, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-29-3130 or A340-29-4098, both dated May 3, 2017, as applicable.
After re-identification of a RAT module on an airplane, as required by paragraph (h)(2) of this AD, the airplane remains compliant with the RAT module re-identification requirements of AD 2016-14-01 for that airplane.
(1) For Group 1 airplanes: After replacement of any affected RAT hydraulic pump as required by paragraph (h)(1) of this AD, do not install any affected RAT hydraulic pump.
(2) For Group 2 airplanes: As of the effective date of this AD, do not install any affected RAT hydraulic pump.
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2018-0062, dated March 20, 2018, for related information. This MCAI may be found in the AD docket on the internet at
(2) For more information about this AD, contact Vladimir Ulyanov, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax: 206-231-3229.
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) Airbus Service Bulletin A330-29-3130, dated May 3, 2017.
(ii) Airbus Service Bulletin A340-29-4098, dated May 3, 2017.
(iii) UTC Aerospace Systems Service Bulletin ERPS06M-29-22, dated March 17, 2017.
(iv) UTC Aerospace Systems Service Bulletin ERPS06M-29-22, Revision 1, dated June 27, 2017.
(v) UTC Aerospace Systems Service Bulletin ERPS06M-29-22, Revision 2, dated May 24, 2018.
(3) For Airbus SAS service information identified in this AD, contact Airbus SAS, Airworthiness Office—EIAS, Rond-Point Emile Dewoitine No: 2, 31700 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
(4) For UTC Aerospace service information identified in this final rule, contact UTC Aerospace Systems Goodrich Corporation, Actuation Systems, Stafford Road, Fordhouses, Wolverhampton, West Midlands WV10 7EH, England; phone: +44 (0) 1902 624644938; fax: +44 (0) 1902 788100624947; email:
(5) You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.
(6) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for certain Zodiac Seats France 536 Series Cabin Attendant Seats. This AD was prompted by cracks found in a highly concentrated stress area of the seat pan hinges. This AD requires repetitive inspections and replacement of the seat pan. We are issuing this AD to address the unsafe condition on these products.
This AD is effective December 28, 2018.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of December 28, 2018.
For service information identified in this final rule, contact Zodiac Seats France, Rue Robert Marechal Senior B.P. 69, 36100 Issoudun, France; phone: +33 (0) 2 54 03 39 39; fax: +33 (0) 2 54 03 39 00; email:
You may examine the AD docket on the internet at
Dorie Resnik, Aerospace Engineer, Boston ACO Branch, FAA, 1200 District Avenue, Burlington, MA, 01803; phone: 781-238-7693; fax: 781-238-7199; email:
We issued a notice of proposed rulemaking NPRM to amend 14 CFR part 39 by adding an AD that would apply to certain Zodiac Seats France 536 Series Cabin Attendant Seats. The NPRM published in the
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA AD 2017-0001, dated January 6, 2017 (referred to after this as “the MCAI”) to correct an unsafe condition for the specified products. The MCAI states:
Cases of cracks were found on Zodiac Seats France cabin attendant seats 536 series installed on some ATR 42 and ATR 72 aeroplanes. The detected damage was located in the area of the seat pan hinges. Investigations identified that fatigue had caused these cracks in a highly concentrated stress area.
This condition, if not detected and corrected, could lead to failure of the seat, possibly resulting in injury to the seat occupant.
To address this potential unsafe condition, Zodiac Seats France issued Service Bulletin (SB) 536-25-003 to provide inspection and replacement instructions. Consequently, EASA issued AD 2016-0164, requiring repetitive visual inspections of the affected cabin attendant seats and, depending on findings, replacement of the seat pan.
Since that AD was issued, Zodiac Seats France developed a reinforced seat pan, and revised SB 536-25-003 accordingly. After installation of a reinforced seat pan, the seat P/N amendment status is updated.
For the reason described above, this AD retains the requirements of EASA AD 2016-0164, which is superseded, prohibits installation of unreinforced seat pans on seats already modified, and introduces the reinforced seat pan installation as optional terminating action for the repetitive inspections.
You may obtain further information by examining the MCAI in the AD docket on the internet at
We gave the public the opportunity to participate in developing this final rule. We received no comments on the NPRM or on the determination of the cost to the public.
We reviewed the relevant data and determined that air safety and the public interest require adopting this final rule as proposed except for minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for addressing the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We reviewed Zodiac Seats France Service Bulletin (SB) No. 536-25-003, Rev. 3, dated June 2, 2017. The SB describes procedures for inspection, modification, or replacement of the seat pan of certain model seats known to be installed on ATR 42 and ATR 72 airplanes. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We estimate that this AD affects 55 seat assemblies installed on, but not limited to, ATR 42 and ATR 72 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to engines, propellers, and associated appliances to the Manager, Engine and Propeller Standards Branch, Policy and Innovation Division.
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective December 28, 2018.
None.
(1) This AD applies to all Zodiac Seats France Cabin Attendant Seats, 536 Series, part numbers (P/N) 53600, all dash numbers, and all serial numbers, with seat pan P/N F0433453, installed.
(2) These appliances are installed on, but not limited to, ATR 42 and ATR 72 airplanes of U.S. registry.
Joint Aircraft System Component (JASC) Code 2500, Cabin Equipment/Furnishings.
This AD was prompted by cracks found in a highly concentrated stress area of the seat pan hinges. We are issuing this AD to prevent failure of affected seats. The unsafe condition, if not addressed, could result in injury to the seat occupants.
Comply with this AD within the compliance times specified, unless already done.
(1) Before exceeding 2,500 flight cycles (FCs), or within 100 FCs after the effective date of this AD, whichever occurs later, inspect the seat pan structure in both deployed and stowed positions using paragraph 2.A., Accomplishment Instructions, of Zodiac Seats France Service Bulletin (SB) No. 536-25-003, Rev. 3, dated June 2, 2017.
(2) If cracks are found, before the next flight:
(i) Replace seat pan with reinforced seat pan, P/N F0511530, using paragraph 2.B., Accomplishment Instructions, of Zodiac Seats France SB No. 536-25-003, Rev. 3, dated June 2, 2017.
(ii) Re-mark the seat using paragraph 2.C., Accomplishment Instructions, of Zodiac Seats France SB No. 536-25-003, Rev. 3, dated June 2, 2017.
(3) If no cracks are found, do the following:
(i) Re-mark the seat using paragraph 2.C., Accomplishment Instructions, of Zodiac Seats France SB No. 536-25-003, Rev. 3, dated June 2, 2017.
(ii) Reinspect the seat pan every 100 FCs since last inspection, or replace seat pan with reinforced seat pan, P/N F0511530, using paragraph 2.B., Accomplishment.
Instructions, of Zodiac Seats France SB No. 536-25-003, Rev. 3, dated June 2, 2017.
(4) After the effective date of this AD, and until compliance with this AD is accomplished, stow and secure an affected attendant seat in the retracted position to prevent occupancy, in accordance with the provisions and limitations of the applicable Master Minimum Equipment List item.
Installation of a reinforced seat pan, P/N F0511530, using paragraph 2.B., Accomplishment Instructions, of Zodiac Seats France SB No. 536-25-003, Rev. 3, dated June 2, 2017, is terminating action to this AD.
You may take credit for inspections and modifications performed in accordance with Zodiac Seats France SB No. 536-25-003, Rev. 2, dated September 16, 2016, or earlier versions, if you performed these actions before the effective date of this AD.
(1) The Manager, Boston ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO Branch, send it to the attention of the person identified in paragraph (k)(1) of this AD. You may email your request to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(1) For more information about this AD, contact Dorie Resnik, Aerospace Engineer, Boston ACO Branch, FAA, 1200 District Avenue, Burlington, MA, 01803; phone: 781-238-7693; fax: 781-238-7199; email:
(2) Refer to MCAI EASA AD 2017-0001, dated January 6, 2017, for more information. You may examine the MCAI in the AD docket on the internet at
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Zodiac Seats France Service Bulletin No. 536-25-003, Rev. 3, dated June 2, 2017.
(ii) [Reserved.]
(3) For Zodiac Seats France service information identified in this AD, contact Zodiac Seats France, Rue Robert Marechal Senior B.P. 69, 36100 Issoudun, France; phone: +33 (0) 2 54 03 39 39; fax: +33 (0) 2 54 03 39 00; email:
(4) You may view this service information at FAA, Engine & Propeller Standards Branch, 1200 District Avenue, Burlington, MA, 01803. For information on the availability of this material at the FAA, call 781-238-7759.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for Zodiac Aero Evacuation Systems (also known as Air Cruisers Company) fusible plugs installed on emergency evacuation equipment for various transport category airplanes. This AD was prompted by reports indicating that affected fusible plugs activated (vented gas) below the rated temperature. This AD requires an inspection of the fusible plugs to determine the part number and lot number, and replacement of all affected fusible plugs. We are issuing this AD to address the unsafe condition on these products.
This AD is effective December 28, 2018.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of December 28, 2018.
For service information identified in this final rule, contact Air Cruisers, 1747 State Route 34, Wall Township, NJ 07727-3935; phone 732-681-3527; email
You may examine the AD docket on the internet at
Darren Gassetto, Aerospace Engineer, Mechanical Systems and Admin Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7323; fax 516-794-5531; email
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to Zodiac Aero Evacuation Systems (also known as Air Cruisers Company) fusible plugs installed on emergency evacuation equipment for various transport category airplanes. The NPRM published in the
We subsequently issued a supplemental NPRM (SNPRM) that was published in the
We are issuing this AD to address fusible plugs that might activate below the rated temperature and render the evacuation system unusable.
We gave the public the opportunity to participate in developing this final rule. The following presents the comments received on the SNPRM and the FAA's response to each comment.
Airlines for America (A4A), on behalf of its members, requested that we extend the compliance time specified in paragraph (h) of the proposed AD (in the SNPRM). A4A stated that the extended compliance time of 42 months after the effective date (in paragraph (g) of the proposed AD (in the SNPRM)) had an unintended consequence in the re-worded compliance paragraph (h) of the proposed AD (in the SNPRM). A4A noted that while the allowance for maintenance records inspection was added, the words “[b]efore further flight” remained. A4A concluded that the current version means that either a planeside finding or a maintenance records discovery will each require action before further flight. A4A stated that while a finding by direct inspection will happen only in a shop and not affect operation of any aircraft, the accommodation for records review could immediately ground an in-service aircraft. A4A requested that we allow 42 months for the replacement if a records review was done.
We agree to revise the compliance time in paragraph (h) of this AD because we have determined that a compliance time of 42 months to replace the affected part addresses the unsafe condition and provides an acceptable level of safety. We have revised paragraph (h) of the AD to specify a 42-month compliance time for the replacement.
All Nippon Airways (ANA) requested that we revise paragraph (c) of the proposed AD (in the SNPRM) to refer to service information that specifies the serial numbers and not only the part numbers of the affected emergency equipment. ANA stated that identifying affected [parts] by only the part number means that even after expiration of the compliance time specified in the proposed AD, the inspection must be continued every time the affected emergency equipment is purchased. ANA stated that the serial number of the affected emergency equipment should be specified in the service information listed in paragraph (c) of the proposed AD (in the SNPRM) in order to prevent endless inspections.
We do not agree because specific serial numbers for the affected emergency equipment have not been identified. In addition, since the fusible plugs are rotable we cannot limit the applicability to only the known emergency equipment on which the fusible plugs were initially installed. Therefore, in order to address the identified unsafe condition, all fusible plugs installed on emergency evacuation equipment identified in the service information specified in paragraph (c) of this AD must be inspected as specified in paragraph (g) of this AD. When installing new equipment on an airplane, operators must ensure the newly installed part is not one of the affected parts by complying with the parts installation prohibition specified in paragraph (i) of this AD. We have not changed this AD in this regard.
Southwest Airlines (SWA) and A4A, on behalf of its members, requested that we refer to service information for accomplishing the actions specified in paragraph (g) of the proposed AD (in the SNPRM). SWA stated that the Air Cruisers service bulletins listed in paragraphs (c)(1) through (c)(16) of the proposed AD (in the SNPRM) have steps to inspect for the affected fusible plugs and to remove fusible plugs that are stamped with Lot PA-21 or PA-22. SWA noted that the service bulletins have been incorporated into the various
A4A and SWA also stated that maintenance records would not indicate the level of detail of the fusible plug part numbers and lot numbers installed. SWA stated that the revision of the CMM used to make the components serviceable is noted on FAA Form 8130-3. A4A also stated that access to the fusible plug part number and lot number is not achievable planeside, and noted that the equipment manufacturer recommends the system to be unpacked and inspected in the slide shop. SWA and A4A requested that paragraph (g) of the proposed AD (in the SNPRM) be revised to specify accomplishing the inspection in accordance with the applicable service information specified in paragraphs (c)(1) through (c)(16) of the proposed AD (in the SNPRM) and/or the applicable component maintenance manuals.
We do not agree with revising paragraph (g) of this AD to mandate service information because this AD does not require operators to accomplish the inspection using a specific method. However, we do agree that operators should be aware of the service information that can be used to do the inspection specified in paragraph (g) of this AD. Therefore, we have added Note 1 to paragraph (g) of this AD to specify service bulletins and CMMs that provide guidance for performing the inspection. We have redesignated subsequent notes in this AD accordingly.
We also acknowledge the commenters' statement that the records review might not be conclusive. As stated in paragraph (g) of this AD, the records review is allowed only if operators can conclusively determine the part number and lot number. For operators that do not have records that can conclusively determine the part number and lot number, the inspection must be done.
SWA requested that we remove paragraph (h) of the proposed AD (in the SNPRM). SWA stated that paragraph (h) of the proposed AD (in the SNPRM) would require immediate removal of the emergency equipment if an inspection or a records review determines an affected part is installed. SWA suggested that paragraph (h) of the proposed AD (in the SNPRM) be deleted because it is unnecessary. SWA stated the emergency equipment must be removed from the aircraft in order to inspect for the affected fusible plug. SWA noted the component maintenance documents do not provide the level of detail of the fusible plug part numbers and lot numbers installed.
We do not agree with removing paragraph (h) of this AD because in order to address the unsafe condition the affected fusible plug must not only be removed but must also be replaced as required by paragraph (h) of this AD. We have not changed this AD in this regard. However, as stated previously, we have revised the compliance time in paragraph (h) of this AD to specify replacing within 42 months instead of requiring immediate action.
SWA requested that we give credit for inspections of the affected fusible plugs previously done per Air Cruisers service bulletins and/or CMMs incorporating the requirements of the Air Cruisers service bulletins.
We agree to clarify. We have not mandated specific service information for accomplishing the actions specified in paragraphs (g) and (h) of this AD; therefore, it is not necessary to give credit for using specific service information. For operators that have already accomplished the actions required by paragraphs (g) and (h) of this AD, credit is given as specified in paragraph (f) of this AD, which states to accomplish the required actions within the compliance times specified, “unless already done.” Therefore, if operators have accomplished the actions required for compliance with paragraphs (g) and (h) of this AD before the effective date of this AD, no further action is necessary.
A4A, on behalf of its members, requested that we revise paragraph (i) of the proposed AD (in the SNPRM) to specify that no person may install on any airplane any slide, slide/raft, or off-wing escape system unless the inspection of the fusible plug has been done per the applicable service information specified in paragraphs (c)(1) through (c)(16) of the proposed AD (in the SNPRM) and/or the applicable CMM listed in Air Cruisers Service Information Letter (SIL) 25-246, Rev. No. 2, dated January 24, 2017. A4A stated that paragraph (i) of the proposed AD (in the SNPRM) does not sufficiently close the door on direct inspection of the plug, which can only be accomplished by unpacking slides and complete disassembly. A4A stated that only the inspection of records (including service bulletin accomplishment information directly stamped on the slide) can reasonably accomplish the intention of the proposed AD in a practical manner.
We do not agree because we have not mandated the service information specified by the commenter. In order to comply with paragraph (i) of this AD, operators must prevent the installation of an affected part on an airplane. Paragraph (i) of this AD does not mandate a specific method for operators to follow to ensure the affected part is not installed. We have not changed this AD in this regard.
A4A, on behalf of its members, requested that we revise the cost estimate. A4A stated that the NPRM assumes one hour of labor per aircraft. A4A noted that because the actions need to be done at an appropriate facility (off wing and often not the operator's own shop), the cost should be per system, and include all facets from uninstalling through reinstallation. A4A stated the operator's actions will consume closer to 4 hours per slide (at $85/hour), with the addition of $500 each way shipping, and the vendor cost (Zodiac's typical billing is $2,900 per slide).
We agree with revising the cost estimate because operators that cannot do a records review will need to remove the affected emergency equipment to accomplish the inspection. We disagree with including the shipping and vendor costs because not all operators will need to ship the equipment in order to do the inspection or records review. We have revised the Costs of Compliance section in this final rule to specify up to 4 work-hours for the inspection.
In paragraph (h) of the proposed AD (in the SNPRM), we specified to replace the fusible plug with a new part that does not have P/N B13984-3, stamped with Lot PA-21 or PA-22. However, we have determined that it is not necessary for the replacement part to be a new part. Therefore, we have revised paragraph (h) of this AD to specify to replace the fusible plug with a serviceable fusible plug P/N B13984-3 that is not stamped with Lot PA-21 or PA-22.
We have reviewed Air Cruisers Service Information Letter (SIL) 25-246, Rev. No. 2, dated January 24, 2017, which indicates additional fusible plugs
In the Summary of the SNPRM, we noted that Zodiac Aero Evacuation Systems was formerly known as Air Cruisers. However, Zodiac Aero Evacuation Systems is also known as Air Cruisers Company. For clarity, we have referred to the manufacturer as Zodiac Aero Evacuation Systems (also known as Air Cruisers Company) throughout this final rule.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule with the changes described previously and minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the SNPRM for addressing the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the SNPRM.
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this final rule.
We reviewed the following Air Cruisers service information. The service information identifies the affected fusible plugs. In addition, it describes procedures for inspecting and replacing affected fusible plugs. These documents are distinct since they apply to different airplane models or configurations.
• Air Cruisers Service Bulletin 737 103-25-50, dated August 27, 2010.
• Air Cruisers Service Bulletin 757 105-25-80, dated August 27, 2010.
• Air Cruisers Service Bulletin 757 105-25-81, dated August 27, 2010.
• Air Cruisers Service Bulletin 767 106-25-10, Rev. No. 1, dated October 15, 2010.
• Air Cruisers Service Bulletin 777 107-25-29, Rev. No. 1, dated July 8, 2011.
• Air Cruisers Service Bulletin A300/A310 001-25-19, dated August 27, 2010.
• Air Cruisers Service Bulletin A300/A310 003-25-33, dated August 27, 2010.
• Air Cruisers Service Bulletin A310 002-25-08, dated August 27, 2010.
• Air Cruisers Service Bulletin A320 004-25-87, Rev. No. 2, dated January 7, 2011.
• Air Cruisers Service Bulletin A321 005-25-21, dated August 27, 2010.
• Air Cruisers Service Bulletin BAe 146 201-25-23, dated December 10, 2010.
• Air Cruisers Service Bulletin F28 352-25-02, dated December 10, 2010.
• Air Cruisers Service Bulletin F100 351-25-07, dated December 10, 2010.
• Air Cruisers Service Bulletin Liferaft 35-25-79, dated August 27, 2010.
• Air Cruisers Service Bulletin MD11 305-25-35, dated August 27, 2010.
• Air Cruisers Service Bulletin MD80/90/717 304-25-45, dated August 27, 2010.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We estimate that this AD affects 3,384 airplanes of U.S. registry. We estimate the following costs to comply with this AD:
We estimate the following costs per slide to do any necessary replacement of the fusible plug that would be required based on the results of the inspection. We have no way of determining the number of aircraft that might need these replacements:
According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all available costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective December 28, 2018.
None.
This AD applies to Zodiac Aero Evacuation Systems (also known as Air Cruisers Company) fusible plugs installed on emergency evacuation equipment identified in the service information specified in paragraphs (c)(1) through (c)(16) of this AD. These affected fusible plugs might be installed on the emergency evacuation equipment of the following manufacturers' airplanes: Airbus, The Boeing Company, BAE Systems (Operations) Limited, and Fokker Services B.V.
(1) Air Cruisers Service Bulletin 737 103-25-50, dated August 27, 2010.
(2) Air Cruisers Service Bulletin 757 105-25-80, dated August 27, 2010.
(3) Air Cruisers Service Bulletin 757 105-25-81, dated August 27, 2010.
(4) Air Cruisers Service Bulletin 767 106-25-10, Rev. No. 1, dated October 15, 2010.
(5) Air Cruisers Service Bulletin 777 107-25-29, Rev. No. 1, dated July 8, 2011.
(6) Air Cruisers Service Bulletin A300/A310 001-25-19, dated August 27, 2010.
(7) Air Cruisers Service Bulletin A300/A310 003-25-33, dated August 27, 2010.
(8) Air Cruisers Service Bulletin A310 002-25-08, dated August 27, 2010.
(9) Air Cruisers Service Bulletin A320 004-25-87, Rev. No. 2, dated January 7, 2011.
(10) Air Cruisers Service Bulletin A321 005-25-21, dated August 27, 2010.
(11) Air Cruisers Service Bulletin BAe 146 201-25-23, dated December 10, 2010.
(12) Air Cruisers Service Bulletin F28 352-25-02, dated December 10, 2010.
(13) Air Cruisers Service Bulletin F100 351-25-07, dated December 10, 2010.
(14) Air Cruisers Service Bulletin Liferaft 35-25-79, dated August 27, 2010.
(15) Air Cruisers Service Bulletin MD11 305-25-35, dated August 27, 2010.
(16) Air Cruisers Service Bulletin MD80/90/717 304-25-45, dated August 27, 2010.
Air Transport Association (ATA) of America Code 25, Equipment/furnishings.
This AD was prompted by reports indicating that affected fusible plugs activated (vented gas) below the rated temperature. We are issuing this AD to address fusible plugs that might activate below the rated temperature and render the evacuation system unusable.
Comply with this AD within the compliance times specified, unless already done.
Within 42 months after the effective date of this AD, do an inspection to determine if any fusible plug has part number (P/N) B13984-3, stamped with Lot PA-21 or PA-22. A review of the airplane maintenance records is acceptable to make this determination if it can be conclusively determined from that review that a part not having P/N B13984-3, stamped with Lot PA-21 or PA-22, has been installed.
If, during the inspection or records review required by paragraph (g) of this AD, it is determined that any fusible plug has part number (P/N) B13984-3, stamped with Lot PA-21 or PA-22: Within 42 months after the effective date of this AD, replace that fusible plug with a serviceable fusible plug P/N B13984-3 that is not stamped with Lot PA-21 or PA-22.
As of the effective date of this AD, no person may install on any airplane any fusible plug having P/N B13984-3, stamped with Lot PA-21 or PA-22.
(1) The Manager, New York ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the certification office, send it to ATTN: Program Manager, Continuing Operational Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone: 516-228-7300; fax: 516-794-5531.
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(1) For more information about this AD, contact Darren Gassetto, Aerospace Engineer, Mechanical Systems and Admin Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7323; fax 516-794-5531; email
(2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (l)(3) and (l)(4) of this AD.
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this
(2) You must use this service information as applicable to determine parts that are affected by this AD, unless the AD specifies otherwise.
(i) Air Cruisers Service Bulletin 737 103-25-50, dated August 27, 2010.
(ii) Air Cruisers Service Bulletin 757 105-25-80, dated August 27, 2010.
(iii) Air Cruisers Service Bulletin 757 105-25-81, dated August 27, 2010.
(iv) Air Cruisers Service Bulletin 767 106-25-10, Rev. No. 1, dated October 15, 2010.
(v) Air Cruisers Service Bulletin 777 107-25-29, Rev. No. 1, dated July 8, 2011.
(vi) Air Cruisers Service Bulletin A300/A310 001-25-19, dated August 27, 2010.
(vii) Air Cruisers Service Bulletin A300/A310 003-25-33, dated August 27, 2010.
(viii) Air Cruisers Service Bulletin A310 002-25-08, dated August 27, 2010.
(ix) Air Cruisers Service Bulletin A320 004-25-87, Rev. No. 2, dated January 7, 2011.
(x) Air Cruisers Service Bulletin A321 005-25-21, dated August 27, 2010.
(xi) Air Cruisers Service Bulletin BAe 146 201-25-23, dated December 10, 2010.
(xii) Air Cruisers Service Bulletin F28 352-25-02, dated December 10, 2010.
(xiii) Air Cruisers Service Bulletin F100 351-25-07, dated December 10, 2010.
(xiv) Air Cruisers Service Bulletin Liferaft 35-25-79, dated August 27, 2010.
(xv) Air Cruisers Service Bulletin MD11 305-25-35, dated August 27, 2010.
(xvi) Air Cruisers Service Bulletin MD80/90/717 304-25-45, dated August 27, 2010.
(3) For service information identified in this AD, contact Air Cruisers, 1747 State Route 34, Wall Township, NJ 07727-3935; phone 732-681-3527; email
(4) You may view this service information at the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Energy Regulatory Commission, Department of Energy.
Policy statement.
In this Policy Statement, the Federal Energy Regulatory Commission (Commission) states its policy regarding the treatment of Accumulated Deferred Income Taxes for both accounting and ratemaking purposes as to Commission-jurisdictional public utilities, natural gas pipelines and oil pipelines, in light of the Tax Cuts and Jobs Act of 2017. In addition, the Commission addresses the accounting and ratemaking treatment of Accumulated Deferred Income Taxes following the sale or retirement of an asset.
This Policy Statement will become applicable November 23, 2018.
1. In this Policy Statement, the Federal Energy Regulatory Commission (Commission) states its policy regarding the treatment of Accumulated Deferred Income Taxes (ADIT) for both accounting and ratemaking purposes as to Commission-jurisdictional public utilities, natural gas pipelines, and oil pipelines, in light of the Tax Cuts and Jobs Act of 2017.
2. On December 22, 2017, the President signed into law the Tax Cuts and Jobs Act. The Tax Cuts and Jobs Act, among other things, reduced the federal corporate income tax rate from 35 percent to 21 percent, effective January 1, 2018.
3. Importantly, the tax rate reduction will also result in a reduction in ADIT liabilities and ADIT assets on the books of rate-regulated companies. ADIT balances are accumulated on the regulated books and records of such regulated companies based on the requirements of the Uniform System of Accounts (USofA).
4. The purpose of tax normalization is to match the tax effects of costs and revenues with the recovery in rates of those same costs and revenues.
5. The Commission established this policy of tax normalization in Order No. 144 where it required use of “the provision for deferred taxes [(
6. Originally promulgated in Order No. 144, the Commission's regulations in 18 CFR 35.24 provide requirements for the proper ratemaking treatment of the tax effects of all transactions for which there are timing differences.
7. Order No. 144 also promulgated the Commission's regulations regarding tax normalization for natural gas pipelines which were originally located in part 2 of the regulations as section 2.202.
8. Unlike the Commission's regulations applicable to public utilities and natural gas pipelines, there is no tax normalization section under the Commission's regulations for oil pipelines. Instead, the Commission's regulations for oil pipelines under the USofA General Instructions, 1-12
9. In Docket No. AI93-5-000, the Chief Accountant issued accounting guidance on the proper accounting for income taxes.
10. Following the enactment of the Tax Cuts and Jobs Act, the Commission issued a Notice of Inquiry seeking comments on, among other things, whether, and if so, how, the Commission should address the effects on ADIT of the Tax Cuts and Jobs Act.
11. This Policy Statement states our requirements regarding the treatment of ADIT in light of the tax rate reduction implemented in the Tax Cuts and Jobs Act. Specifically, we provide guidance regarding: (1) The accounts in which public utilities, natural gas pipelines, and oil companies should record the amortization of excess and/or deficient ADIT for accounting purposes and ratemaking purposes and (2) whether, and if so how, such entities should address excess and/or deficient ADIT that is recorded on the books of public utilities, natural gas pipelines, and oil companies after December 31, 2017, as a result of assets being sold or retired for both accounting and ratemaking purposes.
12. First, we clarify that for both accounting purposes and ratemaking purposes, public utilities and natural gas companies should record the amortization of the excess and/or deficient ADIT recorded in Account 254 (Other Regulatory Liabilities) and/or Account 182.3 (Other Regulatory Assets) by recording the offsetting entries to Account 410.1 (Provision for Deferred Income Taxes, Utility Operating Income) or Account 411.1 (Provision for Deferred Income Taxes—Credit, Utility Operating Income), as required by the USofA. We further clarify that for accounting purposes oil pipelines should adjust their ADIT balances to reflect the change in federal income tax rates with offsetting entries to the appropriate income statement account, as required by the USofA. Accordingly, oil pipeline companies will not record excess or deficient ADIT for accounting purposes. As detailed below, we also clarify that oil pipelines should provide additional disclosures in the Notes that accompany their FERC Form No. 6, Annual Report of Oil Pipeline Companies (Form No. 6).
13. Second, for accounting purposes, we reiterate that public utilities and natural gas pipelines must continue to follow the accounting guidance issued by the Chief Accountant in Docket No. AI93-5-000 with respect to changes in tax law or rates. To ensure transparency in the accounting adjustments to the deferred tax accounts, we clarify that entities should provide additional disclosures in their 2018 FERC annual financial filing within the Notes to the Financial Statements as detailed below.
14. With respect to ratemaking, for a public utility or natural gas pipeline that continues to have an income tax allowance, any excess or deficient ADIT associated with an asset must continue to be amortized in rates even after the sale or retirement of that asset. This excess or deficient ADIT will continue to be refunded to or recovered from ratepayers based on the schedule that was initially established. Similarly, for ratemaking purposes oil pipelines should keep records of excess and deficient ADIT.
15. In the NOI, the Commission sought comment on whether a public utility or natural gas pipeline should record the amortization by recording a reduction to the regulatory asset or regulatory liability account and recording an offsetting entry to Account 407.3 (Regulatory Debits) or Account 407.4 (Regulatory Credits).
16. Ameren takes issue with the premise of the Commission's question that a separate regulatory liability or asset account is necessary to record excess or deficient ADIT, respectively, arguing that the excess or deficient ADIT should remain in the accounts where they were originally recorded.
17. When separate regulatory liability or assets are used, commenters' viewpoints diverge on the appropriate account to record the offsetting entry. Certain commenters agree with the Commission's initial suggestion.
18. Other commenters believe that either Accounts 407.3 and 407.4 or 410.1 (Provision for deferred income taxes, utility operating income) and 411.1 (Provision for deferred income taxes) are appropriate. Avangrid asserts that Account 407 is consistent with the fact that the excess deferred tax obligation ceased upon tax reform enactment and that the utilities will prospectively amortize a regulatory deferral, rather than a deferred tax liability; however, use of Account 411 is consistent with USofA requirements.
19. Many other commenters believe that only Accounts 410.1 and 411.1 are appropriate.
20. Regarding oil pipelines, AOPL states with respect to regulatory accounting under the USofA, any excess ADIT is eliminated when tax rates change consistent with generally accepted accounting principles, rather than being reduced over time through amortization. AOPL states there is no reason to change either the Commission's accounting rules or current oil pipeline accounting practices; the Commission's ratemaking precedent controls rather than accounting rules for purposes of setting cost-of-service rates.
21. We clarify that public utilities and natural gas pipelines should record the amortization of the excess and/or deficient ADIT recorded in Account 254 (Other Regulatory Assets) and/or Account 182.3 (Other Regulatory Assets) by recording the offsetting entries to Account 410.1 (Provision for Deferred Income Taxes, Utility Operating Income) or Account 411.1 (Provision for Deferred Income Taxes—Credit, Utility Operating Income), as appropriate. As explained below, recording the amortization in Account 410.1 and Account 411.1 is consistent with the instructions for those accounts as detailed in the Commission's regulations and provides more transparency as compared with recording the amounts in Account 407.3 and Account 407.4 because the specific source of the regulatory asset or regulatory liability will be known.
22. The Commission's instructions for Account 182.3 provide in part “[w]hen specific identification of the particular source of a regulatory asset cannot be made . . . account 407.4, regulatory credits, shall be credited.”
23. In contrast, Account 410.1 and Account 411.1 are specifically designated for the recordation of ADIT.
24. With respect to oil pipelines, deferred tax balances should be adjusted for the effect of changes in tax law or rates in the period the change is enacted in accordance with the USofA for oil pipelines.
25. With respect to public utilities, the appropriate ratemaking treatment will be addressed in the Notice of Proposed Rulemaking (NOPR) we are issuing concurrent with this Policy Statement. In the NOPR, we are proposing to require all public utility transmission providers with transmission rates under an Open Access Transmission Tariff (OATT), a transmission owner tariff, or a rate schedule to revise those rates to account for changes caused by the Tax Cuts and Jobs Act. Natural gas pipelines should continue to file for changes in rates consistent with sections 154.305, 154.312, and 154.313 of the Commission's regulations.
26. For oil pipelines, the current regulatory treatment of excess and/or deficient ADIT amounts is to maintain such amounts separately for rate making purposes only and to amortize them by removing the annual amortization amount from the cost of service in the process of determining an income tax allowance. We will continue the practice of amortizing and removing the excess and or deficiency by reducing the allowed return before it is grossed up for income taxes.
27. In the NOI, the Commission sought comment on whether, and if so how, it should address excess ADIT that is removed from the books of public utilities, natural gas pipelines, and oil pipelines after December 31, 2017, as a result of assets being sold or retired.
28. Both public utility and natural gas pipeline commenters note that, to date and in response to the last time Congress changed the federal corporate income tax rate, the IRS only has issued guidance on the disposition of excess ADIT in the context of extraordinary retirements.
29. Certain public utilities argue that, for companies that properly reflect Average Rate Assumption or the Reverse South Georgia Method and have formula rates that reflect ADIT balances and adjustments thereto, there is no need for the Commission to address excess ADIT that is removed from the books after December 2017 as a result of assets being sold or retired.
30. Similarly, several natural gas pipelines contend that Commission precedent is clear that when assets are sold or transferred as part of a taxable event, the ADIT balance associated with those assets is extinguished; similarly, deferred liabilities resulting from excess ADIT are also extinguished following the retirement of an asset. These pipelines believe that the Commission has provided no basis for departing from these clear rules.
31. Eversource and Exelon submit that treatment of ADIT balances is best addressed on a company-specific basis and that companies should be able to either remove the ADIT associated with assets removed from their books or continue to amortize those balances over the remaining amortization period.
32. Other commenters urge the Commission to require regulated entities to return any excess ADIT associated with any sold or retired assets. They argue that the Commission should be guided by the principle that all excess ADIT balances were provided by customers and thus customers should be credited with such balances through the combination of a credit to amortization expense and the continued offset to rate base. In support, they assert that when a public utility sells a jurisdictional asset, it will remove from its books the entire ADIT associated with a sold asset, which does not transfer with the asset to the new owner, and retain the entire ADIT for investors. Thus, customers are never credited with the excess or any other part of the ADIT that they have been paying during the useful life of the asset prior to its sale.
33. Indicated Customers note that with regard to the sale of public utility assets for which there is an excess ADIT balance remaining on the books, the 2006 IRS Private Letter Ruling No. PLR-168537-02 prohibits the return to ratepayers of that ADIT and excess ADIT related to the asset that is being sold, because any ADIT and excess ADIT amounts that are on the books for that asset cease to exist as of the date of sale.
34. Commenters that believe that the Commission should require ADIT balances be returned to the customers offer several suggestions. APPA and AMP suggest that in the case of a sale or early retirement of public utility assets, the flowback should occur immediately in the formula rate update after the event; otherwise, the flowback should be in the form of a lump-sum payment or credit.
35. As discussed above, in 1993, the Chief Accountant issued guidance on how entities must account for the effect of a change in tax law or rates by adjusting its deferred tax liabilities and assets.
36. Accordingly, for public utilities and natural gas pipelines, the excess and/or deficient ADIT recorded in Account 254 and/or Account 182.3 should continue to be recorded in those accounts and amortized to Accounts 410.1 and/or Account 411.1, if those balances are still deemed to be either refundable to or recoverable from ratepayers. If the rate treatment of those balances is instead disallowed, then those amounts shall be written off to Account 421 (Miscellaneous Non-Operating Income) or Account 426.5 (Other Deductions), as appropriate, in the year of the disallowance.
37. We clarify that, for public utilities and natural gas pipelines, the balances of excess and deficient ADIT recorded in Account 254 and Account 182.3, respectively, continue to exist as regulatory liabilities and assets after an asset sale, in cases for which the excess and deficient ADIT do not transfer to the purchaser of the plant asset. Similarly, we clarify that public utilities and natural gas companies should continue to account for excess and deficient ADIT related to retirements as regulatory liabilities and assets.
38. We acknowledge that numerous current and deferred tax accounts as well as other accounts may be affected by reversals of ADIT account balances recorded on the books of public utilities and natural gas companies subject to the Commission's jurisdiction. Thus, in order to provide transparency regarding the accounting and rate treatment of amounts removed from the ADIT accounts, we clarify that public utilities and natural gas pipelines should disclose in their FERC annual financial filings within the Notes to the Financial Statements: (1) The FERC accounts affected; (2) how any ADIT accounts were re-measured in the determination of the excess or deficient ADIT amounts in Accounts 182.3 and 254; (3) the related amounts associated with the reversal and elimination of ADIT balances in those accounts; (4) the amount of excess and deficient ADIT that is protected and unprotected; (5) the accounts to which the excess or deficient ADIT will be amortized; and (6) the amortization period of the excess and deficient ADIT to be returned or recovered through rates for both protected and unprotected ADIT.
39. As for oil pipelines, as discussed above, ADIT balances will be reduced immediately by the full amount of the excess or deficient tax reserve in line with the USofA for oil pipelines outlined in General Instruction 1-12.
40. The Commission has previously found that the sale or retirement of an asset with an ADIT balance is usually deemed a taxable event under IRS rules, and, as such, the ADIT balance is extinguished as the deferred taxes then become payable to the appropriate government authorities, and there is no longer an ADIT balance to “return” to customers.
41. Additionally, we note that the rationale for continuing to amortize deficient ADIT or excess ADIT balances in rates upon sales or retirements of assets is substantively similar to the rationale for amortizing excess ADIT in rates for assets that have not been sold or retired. The difference is that for a sale or retirement, ADIT based on a 21 percent tax rate will be settled with the IRS immediately, while for an asset that is not sold or retired, the ADIT will be settled with the IRS over the remaining life of the asset as it depreciates. In other words, the difference between the ADIT for assets that are sold or retired and ADIT for assets that are not sold or retired is the timing of when companies will settle the 21 percent of ADIT with the IRS. In both scenarios, there is excess ADIT based on the 14 percent previously collected from the customers that will no longer be payable to the IRS.
42. While some commenters suggest that continuing to amortize excess or deficient ADIT following a sale or retirement would constitute a normalization violation based on certain IRS private letter rulings, the Commission notes that the IRS established a rulemaking proceeding and reversed its positions made in the PLR referenced by the commenters.
43. Consistent with the above discussion, oil pipelines should continue maintaining excess and/or deficient ADIT within the appropriate ADIT accounts for ratemaking purposes. When jurisdictional assets are retired or sold the oil pipeline should continue to amortize any excess and/or deficient amounts associated with those assets as part of the process of determining an income tax allowance within the rate making process, or seek prior Commission approval to do otherwise.
44. We adopt the policies set forth herein regarding the treatment of ADIT for public utilities, natural gas pipelines and oil pipelines. Above, we state our policy regarding the treatment of ADIT for both accounting and ratemaking purposes as to Commission-jurisdictional public utilities, natural gas pipelines and oil pipelines, in light of the Tax Cuts and Jobs Act of 2017 and also address the accounting and ratemaking treatment of ADIT following the sale or retirement of an asset. We expect such regulated entities to follow these policies absent prior Commission approval to use a different treatment. We further note that if a regulated entity determines that its unique circumstances merit a different treatment of ADIT, such an entity is free to request such treatment at any time.
48. In addition to publishing the full text of this document in the
49. 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.
50. User assistance is available for eLibrary and the FERC's website during normal business hours from FERC Online Support at (202) 502-6652 (toll free at 1-866-208-3676) or email at
51. This Policy Statement will become applicable November 23, 2018.
By the Commission. Commissioner McIntyre is not voting on this order.
Appendix A will not be published in the Code of Federal Regulations.
A—List of Commenters to NOI TABLE
Under Secretary of Defense for Personnel and Readiness (USD(P&R)), DoD.
Final rule.
This rulemaking establishes implementation guidelines for DoD Self-Service (DS) Logon to provide a secure means of authentication to applications containing personally identifiable information (PII) and personal health information (PHI). This will allow beneficiaries and other individuals with a continuing affiliation with DoD to update pay or health-care information in a secure environment. This service can be accessed by active duty, National Guard and Reserve, and Commissioned Corps members of the uniformed services when separating from active duty or from the uniformed service.
This rule is effective on December 24, 2018.
Mr. Robert Eves, Defense Human Resources Activity, 571-372-1956.
On Thursday, November 3, 2016 (81 FR 76325-76330), the Department of Defense (DoD) published a proposed rule titled, “DoD Identity Management” for a 60-day public comment period. When the comment period ended on January 3, 2017, no comments were received.
While in final internal review, it was discovered, based on existing DoD instructions, that only certain retired DoD civilians should be included among the populations eligible for the DS Logon credential as identified in DoD Instruction 1330.17, “DoD Commissary Program,” and DoD Instruction 1330.21, “Armed Services Exchange Regulations.” Only those retired DoD civilians who are eligible for DoD commissary and exchange benefits are eligible for the DS Logon credential. Compliance with existing DoD policy and current instructions required modification of § 221.6(b)(1)(ii) of the final rule, which was amended to read “Eligible retired DoD civilian employees in accordance with DoD Instruction 1330.17, “DoD Commissary Program” (available at
This final rule establishes implementation guidelines for DS Logon and describes procedures for obtaining a DS Logon credential. All active duty, National Guard and Reserve, and Commissioned Corps members of the uniformed services must obtain a DS Logon credential when separating from active duty or from the uniformed service. The DS Logon credential is also available to all beneficiaries that are eligible for DoD-related benefits or entitlements to facilitate secure authentication to critical websites, to include members of the uniformed services, veterans with a continuing affiliation to the DoD, spouses, dependent children aged 18 and over, certain retired DoD civilians, surrogates and other eligible individuals. It discusses how credential holders may maintain and update their credentials and manage their personal settings. Finally, it discusses the permissions credential holders have to access their information, who has access to view and edit their information, and who is eligible to act on their behalf.
DoD collects and maintains information on Service members, beneficiaries, DoD employees, and other individuals affiliated with the DoD in order to issue DoD identification (ID) cards that facilitate access to DoD benefits, DoD installations, and DoD information systems. This action formally establishes DoD policy requirements for DS Logon credentials that are used to facilitate logical access to self-service websites. This regulatory action will update the CFR for DoD Manual (DoDM) 1341.02, Volume 1, “DoD Identity Management: DoD Self-Service (DS) Logon Program and Credential.”
The DoD Personal Identity Protection (PIP) Program uses emerging technologies to support the protection of individual identity and to assist with safeguarding DoD physical assets, networks, and systems from unauthorized access based on fraudulent or fraudulently obtained credentials. DEERS is the authoritative data source for identity and verification of affiliation with the DoD in accordance with the DoD PIP Program. Specific authorities are listed below.
• Title 10 U.S.C. 1044a. This section establishes the authority for a Judge Advocate, other members of the armed forces designated by law and regulations, or other eligible persons to have the powers to act as a notary. The persons identified in Title 10 U.S.C. 1044a subsection (b) have the general power of a notary and may notarize a completed and signed DD Form 3005, “Application for Surrogate Association for DoD Self-Service (DS) Logon.”
• DoD Instruction 1000.25, “DoD Personnel Identity Protection (PIP) Program” (available at
• DoD Instruction 1341.2, “Defense Enrollment Eligibility Reporting System (DEERS) Procedures” (available at
• Office of Management and Budget M-04-04, “E-Authentication Guidance for Federal Agencies” (available at
• 32 CFR part 310. This CFR part established the DoD Privacy Program in accordance with the provisions of the Privacy Act of 1974, and prescribes uniform procedures for the implementation of and compliance with the DoD Privacy Program.
The annual operating costs for the DS Logon program are approximately $1,700,000.00. Based on 6.8 million active users, the cost to the Department per user is about $0.25. This rule is not anticipated to change the population of individuals able to receive a DS Logon account. As part of the proposed rule, DoD requested comments on a new information collection request for this program. No public comment was received. Additional information on the collection can be found in the Paperwork Reduction Act section of this rule.
Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distribute impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. It has been determined that this rule is not a significant regulatory action. The rule does not: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy; a section of the economy; productivity; competition; jobs; the environment; public health or safety; or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another Agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in these Executive Orders.
This final rule is not an E.O. 13771 regulatory action because this rule is not significant under E.O. 12866.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4) requires agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2014, that threshold is approximately $141 million. This final rule would not mandate any requirements for State, local, or tribal governments, nor will it affect private sector costs.
The Department of Defense certifies that this final rule is not subject to the Regulatory Flexibility Act (5 U.S.C. 601) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis.
It has been certified that 32 CFR part 221 does impose reporting or recordkeeping requirements under the Paperwork Reduction Act of 1995. These requirements have been approved by OMB and assigned OMB Control Number 0704-0559, Application for Surrogate Association for DoD Self-Service (DS) Logon.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct effects on the States, the relationship between the National Government and the states, or the distribution of power and responsibilities among the various levels of government. This final rule will not impose such substantial direct effects.
Identity management, Identification cards, Logon credentials.
10 U.S.C. 1044a.
(a) The purpose of the overall part is to implement policy, assign responsibilities, and provide procedures for DoD personnel identification.
(b) This part establishes implementation guidelines for DoD Self-Service (DS) Logon Program.
This part applies to:
(a) The Office of the Secretary of Defense, the Military Departments (including the Coast Guard at all times, including when it is a Service in the Department of Homeland Security, by agreement with that Department), the Office of the Chairman of the Joint Chiefs of Staff and the Joint Staff, the Combatant Commands, the Office of the Inspector General of the Department of Defense, the Defense Agencies, the DoD Field Activities, and all other organizational entities within the DoD (referred to collectively in this part as the “DoD Components”).
(b) The Commissioned Corps of the U.S. Public Health Service (USPHS), under agreement with the Department of Health and Human Services, and the National Oceanic and Atmospheric Administration (NOAA), under agreement with the Department of Commerce.
Unless otherwise noted, the following terms and their definitions are for the purposes of this part:
(1) Conveys the appropriate seal or markings of the issuer;
(2) Has a means to validate the authenticity of the document by a reference or source number;
(3) Is a notarized legal document or other document approved by a judge advocate, member of any of the armed forces, or other eligible person in accordance with 10 U.S.C. 1044a; or
(4) Has the appropriate certificate of authentication by a U.S. Consular Officer in the foreign country of issuance which attests to the authenticity of the signature and seal.
(1) Twenty years marriage, 20 years creditable service for retirement, and 20 years overlap between the marriage and the service (referred to as 20/20/20). The benefits eligibility begins on the date of divorce;
(2) Twenty years marriage, 20 years creditable service for retirement, and 15 years overlap between the marriage and the service (referred to as 20/20/15). The benefits eligibility begins on the date of divorce; or
(3) A spouse whose marriage was terminated from a uniformed Service member who has their eligibility to receive retired pay terminated as a result of misconduct based on Service-documented abuse of the spouse and has 10 years of marriage, 20 years of creditable service for retirement, 10 years of overlap between the marriage and the service (referred to as 10/20/10). The benefits eligibility begins on the date of divorce.
In accordance with DoD Instruction 1000.25, “DoD Personnel Identity Protection (PIP) Program” (available at
(a) The Under Secretary of Defense for Personnel and Readiness (USD(P&R)) oversees implementation of the procedures within this part.
(b) Under the authority, direction, and control of the USD(P&R), and in addition to the responsibilities in paragraph (c) of this section, the Director, DoDHRA, through the Director, DMDC:
(1) Approves the addition or elimination of population categories for DS Logon eligibility.
(2) Develops and fields the required Defense Enrollment Eligibility Reporting System (DEERS) and RAPIDS infrastructure and all elements of field support required to support the management of the DS Logon credential including, but not limited to, issuance, storage, maintenance, and customer service.
(3) Obtains and distributes DS Logon credentials, and provides a secure means for delivery.
(c) The DoD Component heads:
(1) Comply with this part and distribute this guidance to applicable stakeholders.
(2) Provide manpower for issuance of DS Logon credentials and instruction for use to all eligible individuals who are requesting a DS Logon credential in conjunction with the issuance of a DoD identification (ID) card or who are applying for a DS Logon credential as a surrogate, when responsible for a DoD ID card site(s).
(d) The Secretaries of the Military Departments, in addition to the responsibilities in paragraph (c) of this section, and the heads of the non-DoD uniformed services:
(1) Comply with this part and distribute this guidance to applicable stakeholders.
(2) Provide manpower for issuance of DS Logon credentials and instruction for use to all eligible individuals who are requesting a DS Logon credential in conjunction with the issuance of a DoD ID card or who are applying for a DS Logon credential as a surrogate.
(3) Ensure all Active Duty, National Guard and Reserve, and Commissioned Corps members of their uniformed services obtain a DS Logon credential when separating from active duty or from the uniformed service.
(a)
(b)
(1)
(i) Veterans, including former members, retirees, Medal of Honor
(ii) Eligible retired DoD civilian employees in accordance with DoD Instruction 1330.17, “DoD Commissary Program” (available at
(iii) Eligible dependents in accordance with Volume 2 of DoD Manual 1000.13, “DoD Identification (ID) Cards: Benefits for Members of the Uniformed Services, Their Dependents, and Other Eligible Individuals” (available at
(iv) DBs, including eligible widows, widowers, and former spouses, in accordance with Volume 2 of DoD Manual 1000.13.
(v) Surrogates, as described in paragraph (d) of this section.
(vi) Other populations as determined by the Director, DMDC.
(2) [Reserved].
(c)
(i)
(A)
(B)
(
(
(C)
(ii)
(iii)
(A)
(B)
(C)
(2)
(3)
(i) Activate or deactivate an account.
(ii) Reset password.
(iii) Update challenge questions and answers.
(iv) Upgrade from a Basic DS Logon to a Premium DS Logon credential.
(v) Select or update preferred sponsor, if a dependent of two sponsors.
(vi) Manage personal and advanced security settings.
(vii) Manage contact information.
(viii) Manage relationships and access granting.
(ix) Manage the DS Logon credential using additional capabilities as implemented by the Director, DMDC.
(4)
(5)
(d)
(1)
(i)
(ii)
(2)
(i)
(A) A completed and signed DD Form 3005, “Application for Surrogate Association for DoD Self-Service (DS) Logon.”
(B) Any additional eligibility documents required by the DD Form 3005 which describe the scope of the surrogate's authority.
(C) Proof of identity, in accordance with the requirements for in-person proofing in paragraph (c)(1)(iii) of this section.
(ii)
(B)
(C)
(D)
(E)
(F)
(e)
(1)
(2)
(ii)
(3)
(i)
(ii)
(iii)
Coast Guard, DHS.
Final rule.
The Coast Guard is modifying the operating regulation that governs the DELAIR Memorial Railroad Bridge across the Delaware River, mile 104.6, at Pennsauken Township, NJ. This modified regulation will allow the bridge to be remotely operated from the Conrail South Jersey dispatch center in Mount Laurel, NJ, instead of being operated by an on-site bridge tender. This regulation will not change the operating schedule of the bridge.
This rule is effective December 24, 2018.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Mr. Hal R. Pitts, Fifth Coast Guard District (dpb); telephone (757) 398-6222, email
On April 12, 2017, we published a document in the
On June 30, 2017, we published a notice of proposed rulemaking (NPRM) entitled, “Drawbridge Operation Regulation; Delaware River, Pennsauken Township, NJ” (see 82 FR 29800). This proposed regulation would allow the bridge to be remotely operated from the Conrail South Jersey dispatch center in Mount Laurel, NJ, instead of being operated by an on-site bridge tender. This proposed regulation would not change the operating schedule of the bridge. The original comment period closed on August 18, 2017.
During the initial temporary deviation performed from 8 a.m. on April 24, 2017, through 7:59 a.m. on October 21, 2017, the bridge owner identified deficiencies in the remote operation center procedures, bridge to vessel communications, and equipment redundancy. Comments concerning these deficiencies were submitted to the docket and provided to the Coast Guard and bridge owner by representatives from the Mariners' Advisory Committee for the Bay and River Delaware.
On October 18, 2017, we published a document in the
On December 6, 2017, we published a notice of proposed rulemaking; reopening of comment period; entitled “Drawbridge Operation Regulation; Delaware River, Pennsauken Township, NJ” in the
On January 22, 2018, we published a notice of temporary deviation from regulations; reopening comment period; entitled “Drawbridge Operation Regulation; Delaware River, Pennsauken Township, NJ” in the
On February 15, 2018, we published a notice of proposed rulemaking; reopening comment period; entitled “Drawbridge Operation Regulation; Delaware River, Pennsauken Township, NJ” in the
The Coast Guard reviewed 26 comments posted to the docket and six reports with supporting documentation submitted by the bridge owner during the initial and second temporary deviation periods concerning the remote operation system of the DELAIR Memorial Railroad Bridge. Through this review, the Coast Guard found that further testing and evaluation of the remote operation system of the bridge was necessary before making a decision on the proposed regulation.
On April 26, 2018, we published a document in the
On May 4, 2018, we published a notice of proposed rulemaking; reopening comment period; entitled “Drawbridge Operation Regulation; Delaware River, Pennsauken Township, NJ” in the
On October 17, 2018, we published a document in the
In total the Coast Guard received 26 comments posted to the docket and eight reports with supporting documentation submitted by the bridge owner on this rule. No comments were received during the third temporary deviation between April 19, 2018, and October 16, 2018.
The Coast Guard is issuing this rule under authority 33 U.S.C. 499.
The DELAIR Memorial Railroad Bridge across the Delaware River, mile 104.6, at Pennsauken Township, NJ, owned and operated by Conrail Shared Assets, has a vertical clearance of 49 feet above mean high water in the closed-to-navigation position. There is a daily average of 28 New Jersey Transit trains and eight Conrail freight trains that cross the bridge and a daily average of three bridge openings that allow one or more vessels to transit through the bridge during each opening. The bridge is normally maintained in the closed position due to the average daily number of trains crossing the bridge. The operating schedule is published in 33 CFR 117.716. This current operating schedule has been in effect since 1984 and will not change with the implementation of remote operation of the bridge. However, within this modified operating regulation, section 117.716 has been restructured to clearly distinguish the remote operation of the DELAIR Memorial Railroad Bridge. This modified operating regulation allows the bridge to be operated remotely from the bridge owner's South Jersey dispatch center in Mount Laurel, NJ.
The Delaware River is used by a variety of vessels, including deep draft commercial vessels, tug and barge traffic, recreational vessels, and public vessels, including military vessels of various sizes. The three-year average number of bridge openings and maximum number of bridge openings by month and overall for 2013 through 2015, as drawn from the data contained in the bridge tender logs, is presented below.
The bridge owner and the maritime community have been working together since 2013 in an effort to incorporate sensors and other technologies into the bridge and the Conrail South Jersey dispatch center to allow for the safe and effective remote operation of the bridge.
During the initial and second temporary deviation periods between April 24, 2017, and April 19, 2018, 26 comments were received, including three duplicate comments, one process comment, and two comments not related to this rule. No comments were received during the third temporary deviation period between April 19, 2018, and October 16, 2018.
Comments were received from six professional mariners between December 7, 2017, and January 11, 2018, during the second temporary deviation period. These comments expressed concerns associated with the remote operation center's (1) failure to provide timely replies to mariner's requests for a bridge opening, (2) failure to follow established communications protocols, (3) unprofessional responses to mariner's requests and a perception of ineffectual management and a cultural bias against the needs of maritime transportation. These comments were in response to the deficiencies observed during the second temporary deviation period and were observed and reported during the first temporary deviation period, along with corrective actions taken by the bridge owner. Following a review of these comments, the bridge owner acknowledged the recurring deficiencies in the remote operation of the bridge related to human performance factors and management, and reported that additional corrective actions were taken. The Coast Guard found that the bridge owner's actions taken to address the comments received from professional mariners have been satisfactory, given the bridge was operated safely and effectively during the third temporary deviation, which included 681 bridge openings, without further comment from any mariners.
During the first temporary deviation period, comments were received from the Brotherhood of Maintenance of Way Employees Division of the International Brotherhood of Teamsters that: (1) Questioned the remote operation center's capability to safely and effectively operate the bridge, (2) indicated that bridge tenders were currently performing on-site bridge maintenance, inspection and repair functions that would no longer be performed at the required frequencies, and (3) reported multiple remote operation system failure conditions as defined in the notice of proposed rulemaking. The bridge owner advised the Coast Guard that on-site bridge tenders were not responsible for performing on-site bridge maintenance, inspection or repairs functions and that those functions would continue to be performed by qualified personnel. In reviewing the other two comments above in conjunction with the details concerning the remote operation of the bridge during the second and third temporary deviation periods, the Coast Guard has found that the remote operation center is capable of safely and effectively controlling the bridge and early remote operation system failures have been overcome by the bridge owner's corrective actions.
The Delaware Riverkeeper Network submitted comments during the first temporary deviation period indicating that: (1) They were opposed to the regulation based on increased potential for negative environmental impacts to local and regional communities, (2) human oversight via an on-site bridge tender should not be replaced by a remote device, (3) the provision for qualified personnel to return and operate the bridge within 60 minutes was not considered an adequate response time, and (4) they believed that the proposed rule was a significant regulatory action based on increased potential for negative environmental impacts. The Coast Guard reviewed these comments and found that there is no evidence to support that remote operation of the bridge increases the potential for negative environmental impacts and is not likely to have an adverse effect to the environment in a material way, therefore the proposed rule is not a significant regulatory action. The Coast Guard also found that the remote operation system does not replace human oversight, and the 60-minute response time was tested throughout the three temporary deviation periods resulting in effective restoration of the remote operation system of the bridge and no adverse impact on navigation.
12 comments expressed concerns associated with general safety and security of the bridge and the potential inability of remote operation center operators to safely operate the bridge. The Coast Guard found that: (1) Although the on-site bridge tender's duties only include operation of the bridge, the bridge owner's implementation of additional safety and security technologies, in conjunction with the remote operation center's capabilities in providing visibility of the bridge and waterway to the remote operation center operator, adequately addressed the general safety and security related comments. Additionally, the bridge operated safely and effectively during the three temporary deviation periods, which included 2,597 bridge openings.
The Coast Guard finds that the comments received do not require any changes in the regulatory text as presented in the NPRM.
This operating regulation allows the bridge to be operated remotely from the bridge owner's South Jersey dispatch center in Mount Laurel, NJ. The remote operation system includes eight camera views (four marine and four rail), two forward-looking infrared equipped camera views (marine), marine radar, a dedicated telephone line for bridge operations, radio telephone on VHF-FM channels 13 and 16, and an automated identification system (AIS) transmitter to provide bridge status. The AIS transmitter is installed on the New Jersey side of the bridge at the bridge and land intersection in approximate position 39°58′50.52″ N (39.9807), 75°03′58.75″ W (−75.06632). The AIS transmitter is assigned maritime mobile service identity (MMSI) number 993663001 and provides the status of the bridge (open/closed/inoperative) via the name transmitted by the private aids to navigation as DELAIR BRG-OPEN (fully open and locked position, channel light green), DELAIR BRG-CLOSED (other than fully open, not inoperative), or DELAIR BRG-INOP (other than fully open, inoperative). The AIS transmitter transmits the bridge status every two minutes and upon a change in bridge status.
The remote operation system is designed to provide greater or equal visibility of the waterway and bridge and in signals (communications) via sound and visual signals and radio telephone (voice) via VHF-FM channels 13 and 16 compared to the on-site bridge tender. The remote operation system also incorporates real-time bridge status via AIS signal to aid mariners in voyage planning and navigational decision-making, a dedicated telephone line (856) 231-2301 for bridge operations, and push-to-talk (PTT) capability on VHF-FM channel 13.
The signals for the remote operation center or on-site bridge tender to respond to a sound signal for a bridge opening include: (1) When the draw can be opened immediately—a sound signal of one prolonged blast followed by one short blast and illumination of a fixed white light not more than 30 seconds after the requesting signal, and (2) when the draw cannot be opened immediately—five short blasts sounded in rapid succession and illumination of a fixed red light not more 30 seconds after the vessel's opening signal. The signals for the remote operation center or on-site bridge tender to respond to a visual signal for a bridge opening include: (1) When the draw can be opened immediately—illumination of a fixed white light not more than 30 seconds after the requesting signal, and (2) when the draw cannot be opened immediately—illumination of a fixed red light not more 30 seconds after the vessel's opening signal. The fixed white light will remain illuminated until the bridge reaches the fully open position. The fixed white and red lights will be positioned on the east (New Jersey) bridge abutment adjacent to the navigation span.
Vessels that require an opening shall continue to request an opening via the methods defined in 33 CFR 117.15(b) through (d) (sound or visual signals or radio telephone (VHF-FM) voice communications), via telephone at (856) 231-2301, or via push-to-talk (PTT) on VHF-FM channel 13. Vessels may push the PTT button five times while on VHF-FM channel 13 to request an opening.
The remote operation system will be considered in a failed condition and qualified personnel will return and operate the bridge within 60 minutes if any of the following conditions are found: (1) The remote operation system becomes incapable of safely and effectively operating the bridge from the remote operation center, (2) visibility of the waterway or bridge is degraded to less than equal that of an on-site bridge tender (all eight camera views are required), (3) signals (communications) via sound or visual signals or radio telephone (voice) via VHF-FM channels 13 or 16 become inoperative, or (4) AIS becomes inoperative.
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 protesters.
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 rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it 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.
This regulatory action determination is based on the fact that the operating schedule published in 33 CFR 117.716 will not change with the remote operation of the bridge and the remote operation of the bridge is not likely to have an adverse effect to the environment.
The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received zero comments from the Small Business Administration on this rule. 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.
While some owners or operators of vessels intending to transit the bridge 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 calls for no new collection of information under the Paperwork
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.
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 an expenditure, we do discuss the effects of this rule elsewhere in this preamble. The Coast Guard received zero comments concerning the above Act.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a determination that this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule simply promulgates the operating regulations or procedures for drawbridges. This action is categorically excluded from further review, under figure 2-1, paragraph (32)(e), of the Instruction.
A Record of Environmental Consideration and a Memorandum for the Record are not required for this rule.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Bridges.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 117 as follows:
33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 0170.1.
(a) The following apply to all drawbridges across the Delaware River:
(1) The draws of railroad bridges need not be opened when there is a train in the bridge block approaching the bridge with the intention of crossing or within five minutes of the known time of the passage of a scheduled passenger train.
(2) The opening of a bridge may not be delayed more than five minutes for a highway bridge or 10 minutes for a railroad bridge after the signal to open is given.
(3) The owners of drawbridges shall provide and keep in good legible condition two board gages painted white with black figures not less than six inches high to indicate the vertical clearance under the closed draw at all stages of the tide. The gages shall be so placed on the bridge that they are plainly visible to operators of vessels approaching the bridge either up or downstream.
(b) The draw of the Conrail Memorial Railroad Bridge, mile 104.6, at Pennsauken Township, NJ shall be operated as follows:
(1) The bridge will be remotely operated from the Conrail South Jersey dispatch center in Mount Laurel, NJ, unless the remote operation system is in a failed condition.
(2) An AIS transmitter has been installed on the New Jersey side of the bridge at the bridge and land intersection in approximate position 39°58′50.52″ N (39.9807), 75°03′58.75″ (−75.06632). The AIS transmitter is assigned maritime mobile service identity (MMSI) number 993663001. The status of the bridge (open/closed/inoperative) will be provided via the name transmitted by the AIS private aids to navigation as DELAIR BRG-OPEN (fully open and locked position, channel light green), DELAIR BRG-CLOSED (other than fully open, not inoperative), or DELAIR BRG-INOP (other than fully open, inoperative). The AIS transmitter will transmit the bridge status every two minutes and upon a change in the bridge status.
(3) The remote operation system will be considered in a failed condition and qualified personnel will return and operate the bridge within 60 minutes if any of the following conditions are found:
(i) The remote operation system becomes incapable of safely and effectively operating the bridge from the remote operation center; or
(ii) Visibility of the waterway or bridge is degraded to less than equal that of an on-site bridge tender; or
(iii) Signals (communications) via sound or visual signals or radio telephone (voice) via VHF-FM channels 13 or 16 become inoperative; or
(iv) AIS becomes inoperative.
(4) Vessels that require an opening shall continue to request an opening via the methods defined in § 117.15(b) through (d) (sound or visual signals or radio telephone (VHF-FM) voice communications), via telephone at (856) 231-2301, or via push-to-talk (PTT) on VHF-FM channel 13. Vessels may push the PTT button five times while on VHF-FM channel 13 to request an opening.
(5) The signals for the remote operation center or on-site bridge tender to respond to a sound signal for a bridge opening include:
(i) When the draw can be opened immediately—a sound signal of one prolonged blast followed by one short blast and illumination of a fixed white light not more than 30 seconds after the requesting signal; or
(ii) When the draw cannot be opened immediately—five short blasts sounded in rapid succession and illumination of a fixed red light not more 30 seconds after the vessel's opening signal.
(6) The signals for the remote operation center or on-site bridge tender to respond to a visual signal for a bridge opening include:
(i) When the draw can be opened immediately—illumination of a fixed white light not more than 30 seconds after the requesting signal; or
(ii) When the draw cannot be opened immediately—illumination of a fixed red light not more 30 seconds after the vessel's opening signal.
(7) The fixed white light will remain illuminated until the bridge reaches the fully open position. The fixed white and red lights will be positioned on the east (New Jersey) bridge abutment adjacent to the navigation span.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the California Route 160 Drawbridge across Three Mile Slough, mile 0.1, near Rio Vista, CA. The deviation is necessary to conduct preventative maintenance. This deviation allows the bridge to remain in the closed-to-navigation position.
This deviation is effective from 7 a.m. on November 26, 2018, through 4 p.m. on November 27, 2018.
The docket for this deviation, USCG-2018-1010, is available at
If you have questions on this temporary deviation, call or email Carl T. Hausner, Chief, Bridge Section, Eleventh Coast Guard District; telephone 510-437-3516, email
The California Department of Transportation has requested a temporary change to the operation of the California Route 160 Drawbridge over Three Mile Slough, mile 0.1, near Rio Vista, CA The drawbridge navigation span provides a vertical clearance of 12 feet above Mean High Water in the closed-to-navigation position. The draw opens on signal as required by 33 CFR 117.5. Navigation on the waterway is commercial and recreational.
The drawspan will be secured in the closed-to-navigation position from 7 a.m. on November 26, 2018, through 4 p.m. on November 27, 2018, to allow the bridge owner to perform necessary preventative maintenance and non-destructive testing on the bridge's lift span gear box. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised.
Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge will not be able to open for emergencies. The Sacramento River and San Joaquin River can be used as alternate routes for vessels unable to pass through the bridge in the closed position. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for all navigable waters of the Tennessee River from mile marker (MM) 465 to MM 466. This safety zone is necessary to protect persons, property, and the marine environment from potential hazards associated with the construction of an underground pipeline. Entry of vessels or persons into this zone is prohibited unless authorized by the Captain of the Port Sector Ohio Valley or a designated representative.
This rule is effective without actual notice from November 23, 2018 through 7:30 p.m. on January 25, 2019. For the purposes of enforcement, actual notice will be used from November 19, 2018, through November 23, 2018.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Petty Officer Nicholas Jones, Marine Safety Detachment Nashville, U.S. Coast Guard; telephone 615-736-5421, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (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)(3)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. We must establish this safety zone by November 19, 2018, and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule. On November 1, 2018, Reynolds Construction, LLC notified Marine Safety Detachment Nashville that their underwater pipeline construction operations at mile marker 465.2 of the Tennessee River would be ready to commence on November 19,
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it 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 Sector Ohio Valley (COTP) has determined that potential hazards associated with the underwater blasting and pipeline construction will be a safety concern for anyone on a one-mile stretch of the Tennessee River. This rule is necessary to protect persons, vessels, and the marine environment during the construction operations.
This rule establishes a temporary safety zone from mile marker (MM) 465 to MM 466 on the Tennessee River in Chattanooga, TN from 6:30 a.m. on November 19, 2018, through 7:30 p.m. on January 25, 2019. The safety zone will be enforced from 6:30 a.m. through 7:30 p.m. each day, excluding November 22-25, December 8-9, December 22-25, and December 29-January 1. A safety vessel will coordinate all vessel traffic during the enforcement periods. The COTP may terminate enforcement of this rule if the work is finished earlier. The duration of the safety zone is intended to protect persons, vessels, and the marine environment during the construction operations.
No vessel or person is permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of Sector Ohio Valley, U.S. Coast Guard. They may be contacted on VHF Channel 13 or 16, or at 1-800-253-7465. All persons and vessels permitted to enter this safety zone must transit at their slowest safe speed and comply with all directions issued by the COTP or the designated representative. The COTP or a designated representative will inform the public of the enforcement times and dates for this safety zone through Broadcast Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs), as appropriate.
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 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 rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget, and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. This safety zone prohibits transit on a one-mile stretch of the Tennessee River for about 13 hours, on workdays only, during a ten-week period. The rule also allows vessels to seek permission to enter the zone.
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.
While some owners or operators of vessels intending to transit the temporary 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 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
We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (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 prohibits transit on a one-mile stretch of the Tennessee River for about 13 hours on workdays only during a ten-week period. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the U.S. 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. 0170.2.
(a)
(b)
(c)
(d)
(2) Persons or vessels requiring entry into or passage through the area must request permission from the COTP or a designated representative. U.S. Coast Guard Sector Ohio Valley may be contacted on VHF Channel 13 or 16, or at 1-800-253-7465.
(3) A designated safety vessel will coordinate all vessel traffic during the enforcement of this safety zone. All persons and vessels permitted to enter this safety zone must transit at their slowest safe speed and comply with all directions issued by the COTP or the designated representative.
(e)
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce a safety zone for a fireworks display located between mile marker (MM) 94 and (MM) 95, above Head of Passes. This action is needed to provide for the safety of life on navigable waterways during this event.
The regulations in 33 CFR 165.845 will be enforced from 8:15 p.m. through 9:15 p.m. on December 29, 2018.
If you have questions about this notice of enforcement, call or email Lieutenant Commander Benjamin Morgan, Sector New Orleans, U.S. Coast Guard; telephone 504-365-2281, email
The Coast Guard will enforce the safety zone located in 33 CFR 165.845 for the fireworks display from 8:15 p.m. through 9:15 p.m. on December 29, 2018. This action is being taken to provide for the safety of life on navigable waterways during this event. Our regulation for marine events within the Eighth Coast Guard District, § 165.845, specifies the location of the regulated area between mile markers 94 and 95 above Head of Passes on the Lower Mississippi River. If you are the operator of a vessel in the regulated area you must comply with directions from the Patrol Commander or any Official Patrol displaying a Coast Guard ensign.
In addition to this notice of enforcement in the
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is finalizing approval of the emissions inventory, modeled attainment demonstration, determination for Major Stationary Source Reasonably Available Control Technology (RACT), determination for On-Road Mobile Sources Reasonably Available Control Measures (RACM), determination for Cache County Inspection and Maintenance (I/M) Program as additional reasonable measures, determination for Off-Road Mobile Sources RACM, and the 2015 Motor Vehicle Emission Budgets (MVEB) portions of the attainment plan submitted by Utah on December 16, 2014, to address Clean Air Act (CAA or the Act) requirements for the 2006 24-hour fine particulate matter (PM
This final rule is effective on December 24, 2018.
The EPA has established a docket for this action under Docket ID No. EPA-R08-OAR-2016-0585. All documents in the docket are listed on the
Crystal Ostigaard, Air Program, U.S. EPA, Region 8, Mailcode 8P-AR, 1595 Wynkoop Street, Denver, Colorado 80202-1129, (303) 312-6602,
Throughout this document “we,” means the EPA.
On October 17, 2006 (71 FR 61144), the Environmental Protection Agency (EPA) revised the level of the 24-hour fine particulate matter (PM
On December 4, 2017 (82 FR 57183), the EPA proposed to approve portions of the December 16, 2014 Logan, UT-ID Moderate PM
• The 2010 base year and 2015 projection year emissions inventories;
• The modeled attainment demonstration;
• The RACM/RACT and additional reasonable measure determinations for on-road mobile, including the Cache County I/M Program, off-road mobile, and major stationary sources; and
• The direct PM
Our proposal provides details on the EPA's evaluation of these portions of the State's submittal.
The EPA received seven public comments on the proposed action. After reviewing the comments received, the EPA has determined that the comments, with the exception of a portion of one comment, fall outside the scope of our proposed action or fail to identify any material issue necessitating a response.
A portion of one comment (EPA-R08-OAR-2016-0585-0017) generally alleges that the EPA lacks actual measurements of what agriculture emits in the form of PM
Assuming that the comment is intended to refer to the emissions inventories that Utah prepared and submitted for the Logan, UT-ID Moderate PM
For the reasons stated in our proposal, the EPA is finalizing approval of portions of Utah's SIP found at R307-110-10, Section IX Control Measures for Area and Point Sources, Part A, Fine Particulate Matter for the Logan, UT-ID nonattainment area and at SIP Subsection IX.A.23: Control Measures for Area and Point Sources, Fine Particulate Matter for the Logan, UT-ID nonattainment area. Specifically, we are approving the following portions of the Logan, UT-ID Moderate PM
• The 2010 base year and 2015 projection year emissions inventories;
• The modeled attainment demonstration;
• The RACM/RACT and additional reasonable measure demonstrations for on-road mobile, including the Cache
• The direct PM
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the approval of portions of the Logan, UT-ID PM
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this final action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 22, 2019. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Ammonia, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Particulate matter, Reporting and recordkeeping requirements, Sulfur dioxide, Volatile organic compounds.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
The revision and addition reads as follows:
(c) * * *
(e) * * *
Rural Business-Cooperative Service, Rural Housing Service, Rural Utilities Service, Farm Service Agency, USDA.
Proposed rule.
The United States Department of Agriculture (USDA) Rural Development (RD), comprised of the Rural Business-Cooperative Service (RBS), Rural Housing Service (RHS), and Rural Utilities Service (RUS), hereafter referred to as the Agency, proposes amending the Agency's Environmental Policies and Procedures regulation to allow the Agency Administrators limited flexibility to obligate federal funds for infrastructure projects prior to completion of the environmental review while ensuring full compliance with National Environmental Policy Act (NEPA) procedures prior to project construction and disbursement of funding. The proposed change will allow RD to more fully meet the Administration's goals to speed the initiation of infrastructure projects and encourage planned community economic development without additional cost to taxpayers or change to environmental review requirements.
Electronic and written comments must be received on or before December 24, 2018.
Submit your comments on this rule by any of the following methods:
•
•
Kellie McGinness Kubena, Director, Engineering and Environmental Staff, Rural Utilities Service, USDA Rural Development, 1400 Independence Ave. SW, Mail Stop 1571, Room 2242, Washington, DC 20250-1571, Phone: 202-720-1649.
In the rules section of this issue of the
National Credit Union Administration (NCUA).
Proposed rule.
The NCUA Board (Board) is seeking comment on a proposed rule that would amend its regulations regarding fidelity bonds under Part 704 for corporate credit unions and under Part 713 for natural person credit unions. The proposed rule would accomplish four objectives. First, it would strengthen a board of directors' oversight of a credit union's fidelity bond coverage. Second, it would ensure that there is an adequate period to discover and file fidelity bond claims following a credit union's liquidation. Third, it would codify a 2017 NCUA Office of General Counsel legal opinion that permits a natural person credit union's fidelity bond to include coverage for certain credit union service organizations (CUSOs). Fourth, it would clarify the documents subject to Board approval and require that all bond forms receive Board approval every ten years.
Comments must be received on or before January 22, 2019.
You may submit comments by any of the following methods (Please send comments by one method only):
•
•
•
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Rob Robine, Trial Attorney, or Rachel Ackmann, Staff Attorney, Office of General Counsel, 1775 Duke Street, Alexandria, VA 22314-3428 or telephone (703) 548-2601.
The Federal Credit Union Act (FCU Act) requires that certain credit union employees and appointed and elected officials be subject to fidelity bond coverage.
The Board is . . . directed to require that every person appointed or elected by any Federal credit union to any position requiring the receipt, payment, or custody of money or other personal property owned by a Federal credit union or in its custody or control as collateral or otherwise, give bond in a corporate surety company holding a certificate of authority from the Secretary of Treasury . . . as an acceptable surety on Federal bonds. Any such bond or bonds shall be in a form approved by the Board with a view to providing surety coverage to the Federal credit union with reference to loss by reason of acts of fraud or dishonesty including forgery, theft, embezzlement, wrongful abstraction, or misapplication on the part of the person, directly or through connivance with others, and such other surety coverages as the Board may determine to be reasonably appropriate. Any such bond or bonds shall be in such an amount in relation to the . . . assets of the Federal credit union as the Board may from time to time prescribe by regulation[.]
Parts 704 and 713 of the NCUA's regulations implement the requirements of the FCU Act regarding fidelity bonds.
Part 704 was recently revised to amend the provision that determines the maximum amount a credit union may pay for a covered loss, or deductible, before the fidelity bond insurer makes a payment. The NCUA restricts the deductible a corporate credit union may pay to limit the potential losses to it if there is a covered claim. The maximum deductible allowed is a percentage of a corporate credit union's capital based on its leverage ratio. For example, if a corporate credit union has a greater than 2.25 leverage ratio then it may have a maximum deductible that is 15 percent of its tier 1 capital. The recent final rule updated this provision to reference tier 1 capital instead of core capital.
In August 2017, the Board published and sought comment on the NCUA's regulatory reform agenda (Agenda).
As discussed above, Part 713 establishes the minimum requirements for a fidelity bond for a natural person credit union. One such requirement under Part 713 is that fidelity bonds be purchased in an “individual policy.”
OGC's review of Part 713 extended beyond the issue of joint coverage and revealed several inconsistencies between the regulation and approved bond forms. The review also revealed several outdated provisions the Board now seeks to update to ensure the safe and sound operation of credit unions and to protect the National Credit Union Share Insurance Fund (NCUSIF). The Board believes that many of the concerns identified by OGC, as discussed more fully below, are also relevant for corporate credit unions. Therefore, where appropriate, the Board is also proposing amendments to the NCUA's corporate credit union regulations under Part 704. The specific details of the proposed amendments are discussed below.
In general, Part 704 applies to all federally insured corporate credit unions. Section 704.18 provides the fidelity bond requirements for such credit unions. Proposed changes to the specific subparagraphs of § 704.18 are discussed below.
The proposed rule would not make any changes to paragraph (a).
The proposed rule would amend current § 704.18(b) by dividing paragraph (b) into two subparts. Current paragraph (b) would remain unchanged and be designated paragraph (b)(1). The proposed rule would add a new paragraph as (b)(2). Proposed paragraph (b)(2) would require that a corporate credit union's board of directors and supervisory committee must review all applications for purchase or renewal of its fidelity bond coverage. After review, the corporate credit union's board must pass a resolution approving the purchase or renewal of fidelity bond coverage and delegate one member of the board, who is not an employee of the corporate credit union, to sign the purchase or renewal agreement and all attachments. No board members may be a signatory on consecutive purchase or renewal agreements for the same fidelity bond coverage policy. This proposed amendment is identical to proposed changes to Part 713 for natural person credit unions. For additional background, see the discussion below for proposed changes to § 713.2(b).
The proposed rule would make significant revisions to current § 704.18(c). In the proposed rule, § 704.18(c) is split into five new subparagraphs, each of which is described in more detail below.
The proposed rule would state that a corporate credit union's fidelity bond coverage must be purchased from a company holding a certificate of authority from the Secretary of the Treasury. This is not a substantive change from the current requirements and has only been amended to reflect the comparable language in Part 713.
Proposed § 704.18(c)(2) would state that fidelity bonds must provide coverage for the fraud and dishonesty of all employees, directors, officers, and supervisory and credit committee members. This is not a substantive change from the current requirements.
The proposed rule would substantively amend the requirements for a corporate credit union's approved bond forms. The revised requirements reflect the changes proposed for natural person credit unions in Part 713. The proposed rule would require the Board to approve all bond forms before a corporate credit union may use them. In addition, a credit union may not use any bond form that has been amended since receiving Board approval or any rider, endorsement, renewal, or other document that limits coverage of approved bond forms without first receiving approval from the Board. As would be required under proposed Part 713, approval of all bond forms expires 10 years after the date the Board approved or reapproved use of the bond form. Any currently approved bond forms would expire on January 1, 2029. For additional background, see the discussion below for proposed changes to § 713.4.
The proposed rule would add a new § 704.18(c)(4) to ensure there is an adequate discovery period, the period to discover and file a claim, following a corporate credit union's liquidation. The revised requirements reflect the changes proposed for natural person credit unions in Part 713. The proposed rule would require fidelity bonds to include an option for the liquidating agent to purchase coverage in the event of an involuntary liquidation that extends the discovery period for a covered loss for at least two years after liquidation. In the case of a voluntary liquidation, fidelity bonds would be required to remain in effect, or provide that the discovery period is extended, for at least four months after the final distribution of assets. For additional background, see the discussion below for proposed changes to §§ 713.3(a)(3) and (4).
The proposed rule would require corporate credit union bonds to include a provision requiring written notification by surety to the NCUA when a credit union's bond is terminated or when the coverage of an employee, director, officer, supervisory or credit committee member has been terminated. The NCUA also must be notified in writing by surety if a deductible is increased above permissible limits. This is not a substantive change from the current requirements.
The proposed rule would not make any changes to paragraphs (d), (e), and (f).
In general, Part 713 applies to all federally insured natural person credit unions and provides the fidelity bond requirements for them. Proposed changes to the specific subsections of Part 713 are discussed below.
The proposed rule would retain most of the current § 713.1 without change, with the following exceptions. The proposed rule would add the words “federally insured” before the words “credit union” to more precisely describe which credit unions are subject to the section. The current rule uses the
The proposed rule would also include a cross reference for corporate credit unions and would state that corporate credit unions must comply with § 704.18 instead of Part 713.
The proposed rule would amend current § 713.2 by dividing the section into two subparagraphs. Current § 713.2 would become paragraph (a). The proposed rule would retain most of the current § 713.2 without change, with the following exception. For consistency with the rest of Part 713, the term “Federal credit union” would be revised to “federally insured credit union.”
The proposed rule would add a new paragraph (b) to § 713.2. Proposed paragraph (b) increases a board of directors' oversight responsibility of its FICU's fidelity bond coverage. Specifically, the Board is proposing to require a FICU's board, and, if applicable, a FICU's supervisory committee, to review all applications for purchase or renewal of bond coverage and to pass a board resolution approving the purchase or renewal. The proposed rule would also require a FICU's board to delegate one board member, who is not an employee of the FICU, to sign the attestation for bond purchase or renewal. This proposal would prohibit the same board member from signing the attestation for renewal in consecutive years.
The Board notes the current rule already requires a FICU's board to annually review its fidelity bond and other insurance coverage to ensure it is adequate. The proposed rule would take that review a step further and require a FICU's board, and, if applicable, its supervisory committee, to review all applications for purchase or renewal of fidelity bond coverage. The Board believes this change will help ensure the board is addressing the adequacy of the coverage at all stages, rather than at an annual point in time that may be retrospective, and require additional steps by the FICU to remedy a deficiency.
The Board is also proposing to require a FICU's supervisory committee to conduct a review of all applications for purchase or renewal of fidelity coverage, in addition to the board. The Board believes this is a function within the responsibilities of a FICU's supervisory committee and will add an additional layer of review. For FISCUs operating without a supervisory committee, its board should implement controls or establish procedures for conducting their own analysis of the FISCU's fidelity bond coverage, as opposed to relying on recommendations from the FISCU's officers.
As noted, the proposed rule would also require a FICU's board to, after conducting its review, pass a resolution approving the purchase or renewal of fidelity coverage and designating a member of the board, who is not an employee of the FICU, to sign applications for purchase, bond renewals, and any accompanying attestations. Also as mentioned, the Board is proposing to require that the member of the board acting as signatory rotate each time the FICU purchases or renews fidelity coverage. The purpose of these requirements is to address the issue of rescission of fidelity coverage when the signatory to the application to purchase or renew coverage is knowledgeable of fraudulent activity. If the signatory to the application for purchase or renewal is knowledgeable of fraudulent activity, the bond issuer may void the policy and not make a payout when losses are discovered. The NCUA believes that a non-employee board member, who would not be involved in the day-to-day operations of a FICU, is less likely to be responsible for a fraudulent activity than an employee. The NCUA also believes that rotating signatories would reduce the potential for the signatory to be knowledgeable of the fraudulent activity.
In the case where the NCUA is a liquidating agent of a FICU, the NCUSIF would suffer losses due to the fidelity bond being voided. In recent years, the NCUSIF has sustained increased losses due to voided fidelity bond coverage. Before 2010, bond rescission was not a material concern for the NCUA. Since 2010, however, the NCUA has had at least three claims denied due to rescinded fidelity bond coverage and the NCUA is concerned that the frequency of rescinded coverage will continue to increase. As of June 2018, the NCUSIF has already lost in excess of $10 million from fidelity bonds that were voided due to the signatory being aware of the fraudulent activities and litigation related to denied claims is ongoing and may result in additional expenses.
The Board believes the proposed changes are only a minimal increase in regulatory burden as the FICU's board is already required to annually review its fidelity bond coverage, but would meaningfully mitigate the risk to the NCUSIF associated with fidelity bond coverage rescission. The Board notes that this proposed requirement is also advantageous to individual FICUs, as this will help prevent them from losing coverage absent involuntary liquidation.
The proposed rule would amend current § 713.3 by renumbering and revising the section. Current § 713.3 would become paragraph (a), current paragraphs (a) and (b) would be renumbered as paragraphs (a)(1) and (a)(2), and two new subparagraphs would be added as (a)(3) and (a)(4). Finally, a new paragraph (b) would also be added.
Current paragraph (b) of § 713.3 states that, at a minimum, a credit union's fidelity bond coverage must include fidelity bonds that cover fraud and dishonesty. The proposed rule would remove the redundant phrase “[i]nclude fidelity bonds that” in current paragraph (b). The proposed rule would read “At a minimum, your bond coverage must: . . . Cover fraud and dishonesty by all employees, directors, officers, supervisory committee members, and credit committee members;”. The change is non-substantive and only intended to remove the unnecessary language and clarify the requirement.
The proposed rule would add a new paragraph (a)(3) to § 713.3. Proposed paragraph (a)(3) would require a FICU to have fidelity bond coverage that includes an option for the liquidating agent to purchase coverage that extends
Under such contracts, the NCUA, as liquidating agent, would not have authority to extend the discovery period following a FICU's closure. There are some instances when liquidation occurs unexpectedly and there is insufficient time to discover a claim before liquidation, or where there is a covered loss, but it is unknown with the specificity required for filing a claim. In such a case, even if the liquidating agent subsequently discovers a covered loss, the fidelity bond issuer may deny the claim. If this happens when the NCUA is liquidating agent, the NCUA would either be forced into litigation to receive payment for the covered loss or not recover for the loss. In either situation, the NCUSIF bears additional losses than if the fidelity bond permitted a reasonable period of discovery. In addition to reducing losses to the NCUSIF, any funds recovered due to an extended discovery period may also be available to pay the failed FICU's creditors and uninsured depositors.
In an attempt to address this gap in coverage, it has been the NCUA's practice to provide notice that there may be a potential claim before a liquidation. This informal solution, however, lacks legal clarity and results in unnecessary risk that an insurer may deny a claim following an involuntary liquidation. The proposed rule would provide the NCUA with an explicit right to extend the discovery period, which should prevent unnecessary losses to the NCUSIF due to contract technicalities.
The proposed rule would require that fidelity bond coverage provide a discovery period of
The Board is also proposing to add a new paragraph (a)(4) to § 713.3 to include a requirement that, for voluntary liquidations, a FICU's fidelity bond coverage remain in effect, or provide that the discovery period is extended, for at least four months after the final distribution of assets. The Board notes that this is currently required for federal credit unions in Part 710, the NCUA's voluntary liquidation regulations, and that this proposed change only reflects that requirement, and does not impose an additional burden for federal credit unions.
The Board is proposing to amend § 713.3 to allow a FICU to have a fidelity bond that covers both it and certain of its CUSOs, as more fully discussed below. Section 713.3 requires that a bond, at a minimum, must be purchased in “an individual policy.”
Since inclusion of this provision in the NCUA's regulations, OGC has issued two public legal opinions interpreting the meaning of “individual policy” and opining on the type of coverage that is prohibited under § 713.3(a).
As noted above, OGC issued a third legal opinion on the “individual policy” requirement in 2017 (2017 legal opinion). The 2017 legal opinion rescinded and replaced the previous two opinions and expanded the permissibility for certain joint coverage provisions under the “individual policy” requirement. OGC and the NCUA's Office of Examination and Insurance determined this broader interpretation was both within the NCUA's legal authority under the FCU Act and a safe and sound practice for FICUs. For clarity and ease of reference, the Board now seeks to incorporate the 2017 legal opinion into Part 713.
The Board, therefore, is proposing to amend § 713.3 to permit a FICU to have a fidelity bond that also covers its CUSO(s). This is permissible if the FICU owns greater than 50 percent of a CUSO it wishes to cover, or a covered CUSO is organized by the FICU for the purpose of handling certain of its business transactions and composed exclusively of its employees. The 50 percent threshold reflects the standard for accounting consolidation under generally accepted accounting principles, or GAAP. A FICU would
The current rule provides that the NCUA will maintain a current list of bond forms approved by the Board for use by FICUs. The rule also states that a FICU must obtain the approval of the Board before it can use any other basic bond form or any rider or endorsement that limits coverage of an approved bond form. The Board is proposing to amend § 713.4 to make several changes to reflect the practices of the NCUA, clarify the list of documents that must have Board approval, and address the expiration and continuing review of approved bond forms. Any questions regarding the NCUA's approval of fidelity bond forms can be directed to the NCUA's OGC, (703) 518-6540, or the Office of Examination and Insurance, (703) 518-6360.
Current § 713.4(a) states that a current listing of basic bond forms that may be used without prior Board approval is on the NCUA's website. The Board is proposing to clarify this requirement by dividing paragraph (a) into two paragraphs. Proposed paragraph (a) would explicitly state that “the NCUA Board must approve all bond forms before federally insured credit unions may use them.”
Proposed paragraph (b) would state that approved bond forms are listed on the NCUA's website and may be used by a FICU without further NCUA approval. If a FICU is unable to access the NCUA's website, it can get a current listing of approved bond forms by contacting the NCUA's Office of Public and Congressional Affairs. The proposed rule would rewrite this provision for clarity, but would not make any substantive changes.
Current paragraph (b), renumbered as paragraph (c), sets forth which fidelity bonds and fidelity bond documents require Board approval. The proposed rule also would set forth which fidelity bonds and fidelity bond documents require Board approval, but would rewrite this provision for clarity. The proposed rule states in paragraph (c) that “Credit unions may not use any of the following without first receiving approval from the NCUA Board.” No substantive changes are intended by this revision, and the revision is only intended to clarify the Board's expectation for FICUs.
The Board is clarifying that any bond form that has been amended or changed since the Board approved it requires new approval from the Board. The Board notes that this policy is the current practice whereby bond issuers submit amended bond forms to the Board for approval under current § 713.4(b)(1). This proposed change is only intended to make the regulation clearer with respect to this requirement.
Current § 713.4(b)(2) requires any rider or endorsement that limits coverage of approved basic bond forms to be approved by the Board. The proposed rule would clarify the list of documents that must receive Board approval. The Board is proposing to state explicitly that renewal forms (and any other document) that limit the coverage of approved bond forms must also receive Board approval. The Board is clarifying the list of documents subject to approval because the Board is aware of instances where the renewal or continuation of coverage forms included language affecting the bond coverage, including language that limited the bond coverage. As such, it is the Board's belief that the renewal form is an extension of the bond form and thus this is not an additional burden but further clarification of what constitutes the bond form.
The Board is proposing to add a new paragraph (d) to sunset its approval on all bond forms ten years after the form is approved. The impetus for this provision is the discovery that Board approved-bond forms were being interpreted in a way that was contrary to the NCUA's understanding of how the bond forms would be used. In addition, a review of previously approved bond forms, as part of issuing the 2017 legal opinion, revealed several instances of outdated provisions, additions that had not been approved by the Board, and some forms that contained provisions that were contrary to the FCU Act and Part 713 of the NCUA's regulations. To avoid instances of this in the future, the Board is proposing to sunset its approval of a bond form after a period of ten years. This ten-year period will begin on the date the Board approves a bond form. The Board notes, however, that the ten-year period will not toll or start over when a bond carrier submits a revision to an approved bond. For example, if the Board approves a bond form on January 1, 2020, and that bond form is subsequently amended and approved by the Board on January 1, 2021, then the bond form will still expire on January 1, 2030, ten years from the date the Board issued its initial approval.
The Board believes this ten-year sunset provision will provide a definitive date at which an approved bond form will be reviewed by the Board to determine if it is still in compliance with the NCUA's regulations. While this provision will require expired bond forms to be resubmitted to the Board, having a clear date upon which the Board's approval will sunset will help all interested parties prepare to resubmit the bond form to ensure continuity in coverage and operations. The Board also notes that should it determine, upon re-review, that a bond form does not comply with the NCUA's regulations, the Board would not require FICUs with coverage under that bond to seek new coverage. In these situations, the Board would require FICUs to seek new coverage under an approved bond form after its current coverage expires per the terms of the contract between the FICU and the bond issuer.
With respect to bond forms that the Board has approved before 2019, the Board is proposing to allow its approval on these forms to continue until January 1, 2029. The Board believes this date for sunset of its approval will provide all currently approved bonds with at least ten years before they must be submitted for review and re-approval. The Board believes this will achieve the goal of ensuring all approved bond forms comply with the NCUA's regulations without imposing unnecessary burden on FICUs or bond issuers.
In addition to including a sunset provision, the Board is also proposing to clarify its right and ability to review a bond form at any time. The Board notes that if it does undertake a review of an approved bond form during the ten-year period, this will not re-start or toll the expiration period and the Board's approval of that form will still sunset ten years from the date the Board issued its original approval.
As discussed above, the proposed rule would use the term federally insured credit union instead of federal credit union in each of §§ 713.5, 713.6, and 713.7
The Board invites comment on all aspects of this proposed rulemaking. In particular, the Board seeks comment on whether FICUs anticipate any increase in compliance burden under the proposed rule.
The Paperwork Reduction Act of 1995 (PRA) applies to rulemakings in which an agency by rule creates a new paperwork burden on regulated entities or modifies an existing burden. For purposes of the PRA, a paperwork burden may take the form of a reporting, disclosure, or recordkeeping requirement, each referred to as an information collection. The NCUA may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number.
A proposed change to Part 713 would require NCUA approval on all bond forms expired after a period of 10 years from the date of NCUA approval or reapproved of its use. The bond company would be required to seek NCUA approval before a bond form may be used by a FICU. The information collection burden associated with this proposed new requirements is minimal, only affecting an estimated two entities annually; for an increase of two hours to the currently approved OMB control number 3133-0170.
The NCUA invites comments on: (a) Whether the collections of information are necessary for the proper performance of the agencies' functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the information collections, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the information collections on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
All comments are a matter of public record. Comments regarding the information collection requirements of this rule should be sent to (1) Dawn Wolfgang, NCUA PRA Clearance Officer, National Credit Union Administration, 1775 Duke Street, Suite 5080, Alexandria, Virginia 22314, or Fax No. 703-519-8572, or Email at
The Regulatory Flexibility Act (RFA) generally requires that, in connection with a notice of proposed rulemaking, an agency prepare and make available for public comment an initial regulatory flexibility analysis that describes the impact of a proposed rule on small entities. A regulatory flexibility analysis is not required, however, if the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities (defined for purposes of the RFA to include credit unions with assets less than $100 million) and publishes its certification and a short, explanatory statement in the
The Board does not believe that the proposed rule would have a significant economic impact on a substantial number of small entities. Any increased costs for the bond insurer to resubmit their forms every ten years would be spread out among all FICUs and the cost to each FICU would be negligible. Additionally, the proposed requirement that boards, and if applicable, supervisory committees, must approve purchases and renewals would impose no direct cost on FICUs. Accordingly, the NCUA certifies that the proposed rule will not have a significant economic impact on a substantial number of small FICUs.
Executive Order 13132 encourages independent regulatory agencies to consider the impact of their actions on state and local interests. The NCUA, an independent regulatory agency as defined in 44 U.S.C. 3502(5), voluntarily complies with the executive order to adhere to fundamental federalism principles. This proposed rule will not have a 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. The NCUA has therefore determined that this proposed rule does not constitute a policy that has federalism implications for purposes of the executive order.
The NCUA has determined that this proposed rule would not affect family well-being within the meaning of § 654 of the Treasury and General Government Appropriations Act, 1999, Public Law 105-277, 112 Stat. 2681 (1998).
Bonds, Credit unions, Insurance.
For the reasons discussed above, the NCUA is proposing to amend 12 CFR parts 704 and 713 as follows:
12 U.S.C. 1762, 1766(a), 1772a, 1781, 1789, and 1795e.
(b)
(2) The board of directors and the supervisory committee of each corporate credit union must review all applications for purchase or renewal of its fidelity bond coverage. After review, the credit union's board must pass a resolution approving the purchase or renewal of fidelity bond coverage and delegate one member of the board, who is not an employee of the credit union, to sign the purchase or renewal agreement and all attachments. Provided, however, that no board members may be a signatory on consecutive purchase or renewal agreements for the same fidelity bond coverage policy.
(c)
(2) Fidelity bonds must provide coverage for the fraud and dishonesty of all employees, directors, officers, and supervisory and credit committee members.
(3) The NCUA Board must approve all bond forms before a corporate credit union may use them. Corporate credit unions may not use any bond form that has been amended since the time the NCUA Board approved the form or any rider, endorsement, renewal, or other document that limits coverage of approved bond forms without receiving approval from the NCUA Board. Approval on all bond forms expires 10 years after the date the NCUA Board approved or reapproved use of the bond form; provided, however, that any bond forms approved before 2019 will expire on January 1, 2029 and an NCUA Board-approved amendment to a bond form does not toll or cause the 10-year period to restart. The NCUA reserves the right to review a bond form at any point after its approval.
(4) Fidelity bonds must include an option for the liquidating agent to purchase coverage in the event of an involuntary liquidation that extends the discovery period for a covered loss for at least two years after liquidation. In the case of a voluntary liquidation, fidelity bonds must remain in effect, or provide that the discovery period is extended, for at least four months after the final distribution of assets.
(5) Notwithstanding the foregoing, all bonds must include a provision, in a form approved by the NCUA Board, requiring written notification by surety to NCUA:
(i) When the fidelity bond of a credit union is terminated in its entirety;
(ii) When fidelity bond coverage is terminated, by issuance of a written notice, on an employee, director, officer, supervisory or credit committee member; or
(iii) When a deductible is increased above permissible limits. Said notification shall be sent to NCUA and shall include a brief statement of cause for termination or increase.
12 U.S.C. 1761a, 1761b, 1766(a), 1766(h), 1789(a)(11).
This section provides the requirements for fidelity bonds for federally insured credit union employees and officials and for other insurance coverage for losses such as theft, holdup, vandalism, etc., caused by persons outside the credit union. Federally insured, state-chartered credit unions are required by § 741.201 of this chapter to comply with the fidelity bond coverage requirements of this part. Corporate credit unions must comply with § 704.18 of this chapter in lieu of this part.
(a) The board of directors of each federally insured credit union must at least annually review its fidelity and other insurance coverage to ensure that it is adequate in relation to the potential risks facing the federally insured credit union and the minimum requirements set by the NCUA Board; and
(b) The board of directors, and, if applicable, the supervisory committee of each federally insured credit union, must review all applications for purchase or renewal of its fidelity bond coverage. After review, the federally insured credit union's board must pass a resolution approving the purchase or renewal of fidelity bond coverage and delegate one member of the board, who is not an employee of the federally insured credit union, to sign the purchase or renewal agreement and all attachments; provided, however, that no board members may be a signatory on consecutive purchase or renewal agreements for the same fidelity bond coverage policy.
(a) At a minimum, your bond coverage must:
(1) Be purchased in an individual policy from a company holding a certificate of authority from the Secretary of the Treasury;
(2) Cover fraud and dishonesty by all employees, directors, officers, supervisory committee members, and credit committee members;
(3) Include an option for the liquidating agent to purchase coverage in the event of an involuntary liquidation that extends the discovery period for a covered loss for at least two years after liquidation; and
(4) In the case of a voluntary liquidation, remain in effect, or provide that the discovery period is extended, for at least four months after the final distribution of assets, as required in § 710.2(c) of this chapter.
(b) The requirement in paragraph (a) of this section does not prohibit a federally insured credit union from having a fidelity bond that also covers its credit union service organization (CUSO(s)), provided the federally insured credit union owns more than 50 percent of the CUSO(s) or the CUSO(s) is organized by the federally insured credit union for the purpose of handling certain of its business transactions and composed exclusively of the federally insured credit union's employees.
(a) The NCUA Board must approve all bond forms before federally insured credit unions may use them.
(b) Bond forms the NCUA Board has approved for use by federally insured credit union are listed on the NCUA's website,
(c) Federally insured credit union unions may not use any of the following without first receiving approval from the NCUA Board:
(1) Any bond form that has been amended or changed since the time the NCUA Board approved the form; and
(2) Any rider, endorsement, renewal, or other document that limits coverage of approved bond forms.
(d) Approval on all bond forms expires after a period of 10 years from the date the NCUA Board approved or reapproved use of the bond form. Provided, however, that:
(1) Any bond forms approved before 2019 will expire on January 1, 2029.
(2) An NCUA Board-approved amendment to a bond form does not toll or cause the 10-year period to restart; and
(3) The NCUA reserves the right to review a bond form at any point after its approval.
The NCUA Board may require additional coverage when the NCUA Board determines that a federally insured credit union's current coverage is inadequate. The federally insured credit union must purchase this additional coverage within 30 days.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Dassault Aviation Model FAN JET FALCON, and FAN JET FALCON SERIES C, D, E, F, and G airplanes. This proposed AD was prompted by a determination that new or more restrictive airworthiness limitations and maintenance requirements are necessary. This proposed AD would require revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations and maintenance requirements. We are proposing this AD to address the unsafe condition on these products.
We must receive comments on this proposed AD by January 7, 2019.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
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For service information identified in this NPRM, contact Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000, South Hackensack, NJ 07606; telephone 201-440-6700; internet
You may examine the AD docket on the internet at
Tom Rodriguez, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3226.
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2018-0193, dated September 3, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Dassault Aviation Model FAN JET FALCON and FAN JET FALCON SERIES C, D, E, F, and G airplanes. The MCAI states:
In June 1988, the Federal Aviation Administration sponsored a conference of ageing aircraft, during which the decision was taken to pay particular attention to those. The ATA [Air Transport Association] and the AIA [Aerospace Industries Association] committed themselves to identify and to set up procedures to ensure continued structural integrity on ageing aircraft. Prompted by these actions, Dassault developed the SSIP [Supplemental Structural Inspection Program], aiming to guarantee the
Failure to accomplish these instructions could result in an unsafe condition.
Previously, EASA issued AD 2008-0221 to require accomplishment of the maintenance tasks, and implementation of the airworthiness limitations, as specified in ALS at Revision 7.
Since that [EASA] AD was issued, Dassault issued ALS Revisions 8 and 9, which introduced new and more restrictive maintenance requirements and/or airworthiness limitations.
For the reason described above, this [EASA] AD takes over the requirements for Fan Jet Falcon aeroplanes from EASA AD 2008-0221 and requires accomplishment of the actions specified in the ALS.
Once new [EASA] ADs have been published for all the types addressed by EASA AD 2008-0221, EASA plans to cancel that AD.
The unsafe condition is fatigue cracking and damage in principal structural elements; such fatigue cracking and damage could result in reduced structural integrity of the airplane. Because we determined that a separate FAA AD should be issued for each airplane model due to different ALS requirements, we did not issue an AD that corresponded to EASA AD 2008-0221. You may examine the MCAI in the AD docket on the internet at
Dassault has issued Chapter 5-40, Airworthiness Limitations, DMD 44729, Revision 9, dated November 29, 2017, of the Dassault Aviation Falcon 20 Maintenance Manual. This service information includes life limits for certain airframe components, and describes airworthiness limitations for safe life limits and certification maintenance requirements. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop on other products of the same type design.
This proposed AD would require revising the existing maintenance or inspection program, as applicable, to include new or more restrictive airworthiness limitations and maintenance requirements.
This proposed AD would require revisions to certain operator maintenance documents to include new actions (
The MCAI specifies that if there are findings from the ALS inspection tasks, corrective actions must be accomplished in accordance with Dassault maintenance documentation. However, this proposed AD would not include those requirements. Operators of U.S.-registered airplanes are required by general airworthiness and operational regulations to maintain their airplanes using methods that are acceptable to the FAA. We consider those methods to be adequate to replace parts, perform maintenance tasks, and address any corrective actions necessitated by the findings of the ALS inspections specified in this proposed AD.
We estimate that this proposed AD affects 61 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:
We have determined that revising the existing maintenance or inspection program takes an average of 90 work-hours per operator, although we recognize that this number may vary from operator to operator. In the past, we have estimated that this action takes 1 work-hour per airplane. Since operators incorporate maintenance or inspection program changes for their affected fleet, we have determined that a per-operator estimate is more accurate than a per-airplane estimate. Therefore, we estimate the total cost per operator to be $7,650 (90 work-hours × $85 per work-hour).
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This proposed AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by January 7, 2019.
None.
This AD applies to Dassault Aviation Model FAN JET FALCON, and FAN JET FALCON SERIES C, D, E, F, and G airplanes, certificated in any category, all serial numbers, on which the Dassault Fan Jet Falcon Supplemental Structural Inspection Program (Dassault Service Bulletin (SB) 730), has been embodied into the airplane's maintenance program.
Air Transport Association (ATA) of America Code 05, Time Limits/Maintenance Checks.
This AD was prompted by a determination that new or more restrictive airworthiness limitations and maintenance requirements are necessary. We are issuing this AD to address, among other things, fatigue cracking and damage in principal structural elements; such fatigue cracking and damage could result in reduced structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Within 90 days after the effective date of this AD, revise the existing maintenance or inspection program, as applicable, to incorporate the airworthiness limitations specified in Chapter 5-40, Airworthiness Limitations, DMD 44729, Revision 9, dated November 29, 2017, of the Dassault Aviation Falcon 20 Maintenance Manual. The initial compliance time for accomplishing the actions is at the applicable time specified in Chapter 5-40, Airworthiness Limitations, DMD 44729, Revision 9, dated November 29, 2017, of the Dassault Aviation Falcon 20 Maintenance Manual; or within 90 days after the effective date of this AD; whichever occurs later. Where the threshold column in the table in paragraph B, Mandatory Maintenance Operations, of Chapter 5-40, Airworthiness Limitations, DMD 44729, Revision 9, dated November 29, 2017, of the Dassault Aviation Falcon 20 Maintenance Manual specifies a compliance time in years, those compliance times start from the date of issuance of the original airworthiness certificate or date of issuance of the original export certificate of airworthiness.
After accomplishing the revision required by paragraph (g) of this AD, no alternative actions (
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2018-0193, dated September 3, 2018, for related information. This MCAI may be found in the AD docket on the internet at
(2) For more information about this AD, contact Tom Rodriguez, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3226.
(3) For service information identified in this AD, contact Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000, South Hackensack, NJ 07606; telephone 201-440-6700; internet
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for all Airbus SAS Model A350-941 airplanes. This proposed AD was prompted by reports of an overheat failure mode of the hydraulic engine-driven pump (EDP), and a determination that the affected EDP needs to be replaced with an improved EDP. This proposed AD would require replacement of a certain EDP with an improved EDP. We are proposing this AD to address the unsafe condition on these products.
We must receive comments on this proposed AD by January 7, 2019.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Airbus SAS, Airworthiness Office—EAL, Rond-Point Emile Dewoitine No: 2, 31700 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email
You may examine the AD docket on the internet at
Kathleen Arrigotti, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3218.
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2018-0178, dated August 23, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus SAS Model A350-941 airplanes. The MCAI states:
In the Airbus A350 design, the hydraulic fluid cooling system is located in the fuel tanks. Recently, an overheat failure mode of the hydraulic EDP was found, which may cause a fast temperature rise of the hydraulic fluid.
This condition, if not detected and corrected, combined with an inoperative fuel tank inerting system, could lead to an uncontrolled overheat of the hydraulic fluid, possibly resulting in ignition of the fuel-air mixture in the affected fuel tank.
To address this potential unsafe condition, Airbus issued a Major Event Revision (MER) of the A350 Master Minimum Equipment List (MMEL) that incorporates restrictions to avoid an uncontrolled overheat of the hydraulic system. Consequently, EASA issued Emergency AD 2017-0154-E to require implementation of these dispatch restrictions.
After EASA AD 2017-0154-E was issued, following further investigation, Airbus issued another MER of the A350 MMEL that expanded the number of restricted MMEL items. At the same time, Airbus revised Flight Operation Transmission (FOT) 999.0068/17, to inform all operators accordingly. Consequently, EASA issued AD 2017-0180, retaining the requirements of EASA Emergency AD 2017-0154-E, which was superseded, and requiring implementation of the new Airbus A350 MMEL MER and, consequently, restrictions for aeroplane dispatch.
After EASA AD 2017-0180 was issued, Airbus developed HMCA [Hydraulic Monitoring and Control Application] SW [software] S4.2, embodied in production through Airbus mod 112090, and introduced in service through Airbus SB [service bulletin] A350-29-P012. Consequently, EASA issued AD 2017-0200 [which corresponds to FAA AD 2018-19-19, Amendment 39-19419 (83 FR 48203, September 24, 2018)], retaining the requirements of EASA AD 2017-0180, which was superseded, and requiring modification of the aeroplane by installing HMCA SW S4.2.
Since EASA AD 2017-0200 was issued, it was determined that the affected part need to be replaced with improved EDP. Consequently, Airbus issued the SB [Service Bulletin A350-29-P013, dated March 12, 2018] to provide instructions to replace the affected parts with improved EDP, having P/N [part number] 53098-06, which are embodied in production through Airbus mod 112192.
For the reasons described above, this [EASA] AD retains the requirement of EASA AD 2017-0200, which is superseded, and requires replacement of each affected parts with improved EDP.
You may examine the MCAI in the AD docket on the internet at
Airbus SAS has issued Service Bulletin A350-29-P013, dated March 12, 2018. This service information describes procedures for replacing a certain EDP with an improved EDP. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop on other products of the same type design.
This proposed AD would require accomplishing the actions specified in the service information described previously, except as discussed under “Differences Between this Proposed AD and the MCAI.”
This NPRM does not propose to supersede AD 2018-19-19. Rather, we have determined that a stand-alone AD would be more appropriate to address the changes in the MCAI. This proposed AD would require replacing the EDP with an improved EDP.
The MCAI specifies a modification to install HMCA SW S4.2 on certain airplanes. This proposed AD would not require this modification, since the modification is required by AD 2018-19-19. Additionally, the MCAI prohibits installing software prior to HMCA SW S4.2. This proposed AD would not include that prohibition since it has already been prohibited by AD 2018-19-19.
The MCAI specifies changes to the Airbus MMEL to incorporate dispatch restrictions. However, the FAA MMEL is already updated to incorporate these, and all current and future U.S. operators are already required to use the FAA MMEL, so this proposed AD would not
Further, the MCAI notes that, after completing the modification by installing HMCA SW S4.2 and replacing the EDP with an improved EDP, Airbus A350 MMEL Minor Change V29ME1732522, dated January 3, 2018, and Airbus A350 MMEL Major Change V29ME1734973, dated January 30, 2018, can be implemented for that airplane, and those changes remove certain restrictions for that airplane. For U.S. registered aircraft, no provisions for relief are to be added to the MMEL with incorporation of this proposed AD. The FAA-approved MMEL currently contains more restrictive operational limitations, and we will update it when relief is justified.
In most ADs, we adopt a compliance time allowing a specified amount of time after the AD's effective date. In this case, however, we are using a fixed compliance date in this proposed AD. The MCAI requires operators of all Airbus SAS Model A350-941 airplanes to replace affected EDPs with improved EDPs to address an identified unsafe condition in a specified amount of time (within 17 months after the MCAI's effective date of September 6, 2018, or February 6, 2020). That compliance time is based on risk analysis requirements, including reports of fuel pump overheats and failures. To support this risk analysis, and to provide for coordinated implementation of EASA's regulations and this proposed AD, we are using the same compliance target in this proposed AD.
We estimate that this proposed AD affects 11 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:
According to the manufacturer, some or all of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all known costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This proposed AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by January 7, 2019.
None.
This AD applies to Airbus SAS Model A350-941 airplanes, certificated in any category, all serial numbers.
Air Transport Association (ATA) of America Code 29, Hydraulic power.
This AD was prompted by reports of an overheat failure mode of the hydraulic engine-driven pump (EDP), and a determination that the affected EDP needs to be replaced with an improved EDP. We are issuing this AD to address the overheat failure mode of the hydraulic EDP, which may cause a fast temperature rise of the hydraulic fluid, and, if combined with an inoperative fuel tank inerting system, could lead to an uncontrolled overheat of the hydraulic fluid, possibly resulting in ignition of the fuel-air mixture of the affected tank.
Comply with this AD within the compliance times specified, unless already done.
Before February 6, 2020, replace each EDP having part number (P/N) 53098-04 with an improved EDP, having P/N 53098-06, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A350-29-P013, dated March 12, 2018.
At the applicable time specified in paragraph (h)(1) or (h)(2) of this AD: No person may install an EDP having P/N 53098-04 on any airplane.
(1) For airplanes that, as of the effective date of this AD, have any EDP having P/N 53098-04 installed: After modification of the airplane as specified by paragraph (g) of this AD.
(2) For airplanes that, as of the effective date of this AD, are post-Modification 112192 and do not have any EDP having P/N 53098-04 installed: As of the effective date of this AD.
The following provisions also apply to this AD:
(1)
(2)
(3)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2018-0178, dated August 23, 2018, for related information. This MCAI may be found in the AD docket on the internet at
(2) For more information about this AD, contact Kathleen Arrigotti, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3218.
(3) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAL, Rond-Point Emile Dewoitine No: 2, 31700 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email
Federal Energy Regulatory Commission, Department of Energy.
Notice of proposed rulemaking.
The Federal Energy Regulatory Commission (Commission) is proposing to require all public utility transmission providers with transmission rates under an Open Access Transmission Tariff (OATT), a transmission owner tariff, or a rate schedule to revise those rates to account for changes caused by the Tax Cuts and Jobs Act of 2017 (Tax Cuts and Jobs Act). Specifically, for transmission formula rates, the Commission is proposing to require that public utilities deduct excess accumulated deferred income taxes (ADIT) from or add deficient ADIT to their rate bases and adjust their income tax allowances by amortized excess or deficient ADIT. The Commission is also proposing to require all public utilities with transmission formula rates to incorporate a new permanent worksheet into their transmission formula rates that will annually track ADIT information. Additionally, the Commission is proposing to require all public utilities with transmission stated rates to determine the amount of excess and deferred income tax caused by the Tax Cuts and Jobs Act's reduction to the federal corporate income tax rate and return or recover this amount to or from customers.
Comments are due December 24, 2018.
Comments, identified by docket number, may be filed electronically at
1. In this Notice of Proposed Rulemaking (Proposed Rule), we are proposing to require all public utility transmission providers with transmission rates under an Open Access Transmission Tariff (OATT), a transmission owner tariff, or a rate schedule to revise those rates to account for changes caused by the Tax Cuts and Jobs Act of 2017 (Tax Cuts and Jobs Act).
2. The proposed reforms generally fall into three categories and apply to public utilities with transmission formula rates and stated rates in different ways. First, we propose to require all public utilities with transmission formula rates to include a mechanism in their formula rates to deduct any excess ADIT from or add any deficient ADIT to their rate bases. This will ensure that rate base continues to be treated in a manner similar to that prior to the Tax Cuts and Jobs Act (
3. Second, we propose to require all public utilities with transmission formula rates to include a mechanism in their formula rates that decreases or increases their income tax allowances by any amortized excess or deficient ADIT, respectively. This reform will help to ensure that public utilities with transmission formula rates return excess ADIT to or recover deficient ADIT from ratepayers. As a result, ratepayers who contributed to excess ADIT balances will receive the benefit of the Tax Cuts and Jobs Act.
4. With regard to public utility transmission providers with stated rates, we are proposing to require these entities to determine the excess and deficient ADIT caused by the Tax Cuts and Jobs Act based on the ADIT amounts approved in their last rate case and then to return this amount to or recover this amount from customers. This reform is intended to increase the likelihood that those customers who contributed to the related ADIT accounts receive the benefits of the Tax Cuts and Jobs Act.
5. Third, we propose to require all public utilities with transmission formula rates to incorporate a new permanent worksheet into their transmission formula rate that will annually track information related to excess or deficient ADIT. We believe that this reform will increase the transparency surrounding the
6. We seek comments on these proposed reforms and areas for further comment within 30 days after publication of this Proposed Rule in the
7. On December 22, 2017, the President signed into law the Tax Cuts and Jobs Act. The Tax Cuts and Jobs Act, among other things, reduced the federal corporate income tax rate from 35 percent to 21 percent, effective January 1, 2018. This means that, beginning January 1, 2018, companies subject to the Commission's jurisdiction will compute income taxes owed to the IRS based on a 21 percent tax rate. The tax rate reduction will result in less corporate income tax expense going forward.
8. Importantly, the tax rate reduction will also result in a reduction in ADIT liabilities and ADIT assets on the books of rate-regulated companies. ADIT balances are accumulated on the regulated books and records of public utilities based on the requirements of the Uniform System of Accounts. ADIT arises from timing differences between the method of computing taxable income for reporting to the IRS and the method of computing income for regulatory accounting and ratemaking purposes.
9. The Commission is responsible for ensuring that the rates, terms and conditions of service for wholesale sales and transmission of electric energy in interstate commerce are just, reasonable, and not unduly discriminatory or preferential. With respect to the transmission of electric energy in interstate commerce, most jurisdictional entities are subject to cost of service regulation. Cost of service regulation seeks to allow public utilities the opportunity to (1) recover operating costs, including income taxes, (2) recover the cost of capital investments, and (3) earn a just and reasonable return on investments.
10. When a public utility uses stated rates, if the public utility seeks to change its rate, it files a rate case at the Commission to establish the cost of service revenue requirement, allocate costs to various customer groups, and calculate rates. As an alternative, the Commission permits public utilities to establish rates through formulas, in which the Commission accepts the public utility's cost of service calculation methodologies and input sources and allows the public utility to update those inputs every year.
11. Public utilities must seek changes to their transmission stated rates or formula rates through filings with the Commission under section 205 of the Federal Power Act (FPA),
12. The purpose of tax normalization is to match the tax effects of costs and revenues with the recovery in rates of those same costs and revenues.
13. The Commission established this policy of tax normalization in Order No. 144 where it required use of “the provision for deferred taxes [(
14. Following the enactment of the Tax Cuts and Jobs Act, the Commission issued the NOI seeking comments on, among other things, whether, and if so, how, the Commission should address the effects of the Tax Cuts and Jobs Act on ADIT.
15. Since the issuance of Order No. 144, the landscape of public utility transmission rates has changed dramatically; that is, the vast majority of public utilities now use formula rates rather than stated rates. As described above, unlike stated rates, which are updated only through a rate case initiated by a FPA section 205 application by the public utility or an FPA section 206 action by the Commission or a complaining third party, inputs to formula rates are updated annually to derive a charge assessed to customers. Thus, a rate case no longer remains the appropriate vehicle for formula rates to reflect excess or deficient ADIT in a public utility's cost of transmission service, as contemplated by Order No. 144. The public utility's transmission formula rate should include provisions that accurately reflect excess or deficient ADIT in a public utility's cost of transmission service during the annual updates of the rest of the revenue requirement.
16. Following the NOI, we have determined that this near-industry-wide transition from stated to formula rates has caused a gap in the transmission formula rates of public utilities such that many, if not most, of those rates do not contain provisions to fully reflect any excess or deficient ADIT following a change in tax rates, as required by Order No. 144 and the Commission's regulations in 18 CFR 35.24. Two components are necessary to maintain an accurate cost of service following a change in income tax rates, such as that caused by the Tax Cuts and Jobs Act: (1) Preservation of rate base neutrality through the removal of excess ADIT from or addition of deficient ADIT to rate base; and (2) the return of excess ADIT to or recovery of deficient ADIT from ratepayers.
17. A review of public utility transmission formula rates suggests that only some transmission formula rates contain the first component, while even fewer contain the second. Consequently, as discussed in greater detail below, we propose to require public utilities with transmission formula rates to revise those rates to include these two components. Additionally, to provide greater transparency, we propose to require all public utilities with transmission formula rates to incorporate a new permanent worksheet into their transmission formula rates that will annually track ADIT information related to these two components.
18. Regarding public utilities with transmission stated rates, we propose maintaining Order No. 144's requirement that such public utilities reflect any adjustments made to their ADIT balances as a result of the Tax Cuts and Jobs Act (and any future tax changes) in their next rate case. However, to increase the likelihood that those customers who contributed to the related ADIT accounts receive the benefit of the Tax Cuts and Jobs Act, we propose to require public utilities with transmission stated rates to (1) determine any excess or deficient ADIT caused by the Tax Cuts and Jobs Act and (2) return or recover this amount to or from customers. We believe that the Commission's existing regulations already require all of the information necessary to support the changes proposed herein to reflect the effects of the Tax Cuts and Jobs Act on a transmission stated rate. Therefore, we propose not to require any additional worksheets.
19. The Commission generally does not permit single-issue ratemaking. However, similar to the Commission's actions following the Tax Cuts and Jobs Act,
20. In the NOI, the Commission sought comment on how to ensure that rate base continues to be treated in a manner similar to that prior to the Tax Cuts and Jobs Act (
21. Numerous public utilities and other commenters assert that, in order to preserve rate base neutrality, unamortized balances of excess ADIT must continue to be treated as an offset to (
22. Regarding public utilities with formula rates, several commenters support the addition of a line item to formula rates for rate base adjustments reflecting excess or deficient ADIT recorded in Accounts 254 and 182.3.
23. Alternatively, APPA and AMP, and Indicated Customers suggest that any excess or deficient ADIT resulting from the implementation of the Tax Cuts and Jobs Act be recorded to the same ADIT accounts (
24. Other commenters note that such a line item adjustment may not be necessary in all cases.
25. Regarding public utilities with stated rates, commenters generally agree that adjustments are not necessary to preserve rate base neutrality with respect to stated rates.
26. We propose to require all public utilities with transmission formula rates to include a mechanism in their formula rates which deducts any excess ADIT from or adds any deficient ADIT to their rate bases under 18 CFR 35.24. As described above, the Commission's regulations in 18 CFR 35.24 require public utilities to reflect any excess or deficient ADIT as a result of any changes in tax rates in their next rate case. As a result of the Tax Cuts and Jobs Act's reduction of the federal corporate income tax from 35 percent to 21 percent, public utilities have collected excess funds for their ADIT liabilities and have not collected sufficient funds for any ADIT assets. To preserve rate base neutrality by accurately matching the tax allowance with the current tax cost as required by Commission regulations, public utilities with transmission formula rates must include provisions in their formula rates to adjust their ADIT for excess or deficient ADIT.
27. While we are proposing to require public utilities with transmission formula rates to include a mechanism to adjust rate base for any excess or deficient ADIT, we are not proposing to prescribe a specific adjustment mechanism which applies to all public utilities with transmission formula
28. We are not persuaded by commenters to the NOI who suggest that excess or deficient ADIT amounts should be recorded to the same ADIT accounts where the original entries for the regulatory assets and regulatory liabilities were established. The Commission previously issued guidance on this topic, finding that public utilities are required to record a regulatory asset (Account 182.3) associated with deficient ADIT or regulatory liability (Account 254) associated with excess ADIT.
29. We do not propose any new requirements regarding rate base neutrality for public utilities with transmission stated rates. As noted by commenters to the NOI, stated rates are calculated based in large part on company data submitted, and projections made, at the time of the last rate case. Thus, while ADIT balances may have changed as a result of the Tax Cuts and Jobs Act, so too will many other aspects of the cost of service and calculations that underlie the stated rate, making it difficult to re-evaluate ADIT and its effect on rate base following a change in tax rates without fully evaluating a public utility's entire cost of service and rates.
30. In the NOI, the Commission asked commenters to address how public utilities with stated or formula rates should adjust their income tax allowance such that the allowance would be decreased or increased by the amortization of excess or deficient ADIT, respectively.
31. Commenters generally support adjusting public utilities' income tax allowances by the amortization of excess or deficient ADIT. Many commenters suggest adding a line item or several line items to public utility transmission formula rates to make this adjustment,
32. Commenters also support revisions to transmission stated rates to reflect income tax allowance adjustments for the amortization of excess or deficient ADIT.
33. Some commenters caution the Commission against mandating that public utilities adopt a single method to adjust their formula rates' income tax allowances. Instead, these commenters suggest that the Commission recognize public utilities' specific circumstances by evaluating proposed modifications on a case-by-case basis or recognizing that some formula rates already adjust the income tax allowance by the amortization of excess or deficient ADIT and, therefore, would not require revision.
34. Consumer Advocates are concerned that absent Commission intervention, jurisdictional entities may begin to amortize their excess ADIT, thereby denying customers the full benefit of the Tax Cuts and Jobs Act. Consumer Advocates argue that to the extent any protected ADIT balances have been amortized to date, the Commission should require such excess protected ADIT amortization credits to be reversed and the liability balance restored to that of the implementation date of the Tax Cuts and Jobs Act.
35. Regarding protected excess or deficient ADIT, commenters agree that the Commission has no need to change its existing regulations or precedent or depart from the Tax Cuts and Jobs Act's normalization provisions.
36. We propose to require all public utilities with transmission formula rates to include a mechanism in their formula rates which decreases or increases their income tax allowances by any amortized excess or deficient ADIT, respectively, under 18 CFR 35.24. Such a mechanism is necessary because, as described above, the Tax Cuts and Jobs Act's reduction of the federal corporate income tax rate from 35 percent to 21 percent means public utilities have collected from customers funds in excess of what is due to the IRS for ADIT liabilities and, conversely for ADIT assets, funds from customers insufficient to satisfy IRS tax obligations. Similar to the proposed rate base adjustment requirements, these proposed income tax allowance adjustment requirements are intended to satisfy Order No. 144's requirement that the income tax allowance match the current tax cost and reflect the effects of any future changes to tax rates that may give rise to excess or deficient ADIT.
37. Similar to comments regarding adjustments to rate base, we agree with commenters to the NOI that prescribing a one-size-fits-all approach is not appropriate and that the public utilities with transmission formula rates should instead be allowed to propose any necessary changes to their rates on an individual basis. Accordingly, we do not propose that all public utilities with transmission formula rates must use a single method to adjust their income tax allowances for any amortized excess or deficient ADIT. Many public utilities with transmission formula rates use different formats of rate templates or formulas, and a single, prescriptive method, such as the requirement of a single line item, may not fully capture or transparently convey the amortization of excess or deficient ADIT. Additionally, recent filings by public utilities that proposed revisions to their formula rate templates to reflect changes in income tax rates by, among other things, incorporating mechanisms to return excess ADIT demonstrate that company-specific variations are necessary.
38. Regarding the period over which the amortization of excess or deficient ADIT must occur, we believe that public utilities should follow the guidance provided in the Tax Cuts and Jobs Act, where available. As noted by commenters to the NOI, the Tax Cuts and Jobs Act provides a method of general applicability and requires public utilities to return excess protected ADIT
39. Consumer Advocates are concerned that a portion of the amounts allowable to be returned to customers under the Average Rate Assumption Method schedule would not be refunded due to the fact that any proposed tariff provisions to return excess ADIT as a result of this Proposed Rule will not be effective until after January 1, 2018. We acknowledge that in applying a tax normalization method (
40. We propose to require all public utilities with transmission stated rates to (1) determine the excess and deficient income tax caused by the Tax Cuts and Jobs Act's reduction to the federal corporate income tax rate and (2) return this amount to or recover this amount from customers under 18 CFR 35.24. We also propose for public utilities with transmission stated rates to calculate this excess or deficient ADIT using the ADIT approved in their last rate cases. We believe calculating excess or deficient ADIT in this manner will allow public utilities with transmission stated rates to preserve their costs of service as accepted in their last rate case. We are not seeking to propose a specific way for public utilities with transmission stated rates to return or recover the excess or deficient income taxes to ratepayers; rather, we will evaluate each proposal on an individual basis. We believe the proposed reforms will increase the likelihood that those customers who contributed to the related ADIT accounts receive the benefit of the Tax Cuts and Jobs Act.
41. TAPS expresses concern that the customers of public utilities with transmission stated rates will lack sufficient information to evaluate any proposals to return or recover excess or deficient ADIT, respectively. We note that the Commission's regulations require public utilities filing changes to transmission rates to identify the effect of tax changes on those rates.
42. Finally, as noted above, public utilities with transmission stated rates must conform to the Tax Cuts and Jobs Act's requirements regarding the period over which the amortization of protected excess or deficient ADIT must occur. We will continue to analyze the appropriate amortization period for unprotected ADIT on a case-by-case basis.
43. In the NOI, the Commission sought comment on whether it should require public utilities to provide to the Commission, on a one-time basis, additional information, such as supporting worksheets, to show the computation of excess or deficient ADIT and the corresponding flow-back of excess ADIT to customers or recovery of deficient ADIT from customers. The Commission asked commenters to address what types of information public utilities already record for ADIT-related accounting and whether balances and amortization of regulatory liability and asset accounts, computation of excess and deficient ADIT, delineation between protected and non-protected ADIT, and a description of the allocation method used to determine the transmission-related portion of excess or deficient ADIT would be appropriate to include in a supporting worksheet.
44. Commenters were split regarding the requirement to provide additional worksheets. Some commenters assert that the Commission should not require any additional worksheets at this time.
45. Other commenters, however, assert that the Commission should require electric public utilities to provide a one-time filing of additional information to provide transparency regarding excess and deficient ADIT, and how rates will be impacted by any changes.
46. We propose to require all public utilities with transmission formula rates to incorporate a new permanent worksheet into their transmission formula rates that will annually track information related to excess or deficient ADIT under 18 CFR 35.24. We believe that this reform is necessary to provide interested parties adequate transparency regarding how public utilities with transmission formula rates adjust their rate bases and income tax allowances to account for excess or deficient ADIT. We also believe that requiring public utilities with transmission formula rates to provide this information on an annual basis rather than a one-time basis will better allow interested parties to follow excess or deficient ADIT as it is included in an annual revenue requirement and provide transparency as to any future changes in tax rates. We also believe that updating the proposed worksheet annually will better align with the nature of the vast majority of formula rates where calculation methodologies and input sources are accepted prior to those inputs being populated. Consequently, we do not propose that any worksheet be populated when submitted to the Commission for compliance, only that the function of the worksheet be clear.
47. Similar to other reforms proposed in this Proposed Rule, we do not propose a pro forma worksheet that must be adopted by all public utilities with transmission formula rates; rather, we propose requiring general categories of information that each excess or deficient ADIT tracking worksheet must contain. We propose that each excess or deficient ADIT worksheet must, at minimum, include the following: (1) How any ADIT accounts were re-measured and the excess or deficient ADIT contained therein; (2) the accounting of any excess or deficient amounts in Accounts 182.3 and 254; (3) whether the excess or deficient ADIT is protected or unprotected; (4) the accounts to which the excess or deficient ADIT are amortized; and (5) the amortization period of the excess or deficient ADIT being returned or recovered through the rates. Because we do not propose to define the form any worksheet or worksheets must take, only the information it must contain, we propose evaluating such worksheet or worksheets on an individual basis. We also request comments on whether we should consider additional guiding principles to those described above.
48. We disagree with commenters to the NOI that argue that providing such information is overly burdensome for the industry. Public utilities with transmission formula rates will already have gathered the information we propose to require in the worksheets to re-measure their ADIT balances and develop amortization schedules following the Tax Cuts and Jobs Act's reduction of the federal corporate income tax rate. Further, the Commission has already accepted worksheets that convey information similar to the proposed requirements outlined above.
49. We also disagree with commenters to the NOI that public utilities' existing formula rate protocols should preclude the Commission from proposing an excess or deficient ADIT worksheet. While the Commission established that formula rate protocols should allow for the provision of any information necessary to understand the inputs to the rate in order to provide sufficient transparency to interested parties, the Commission has since required public utilities to revise their formula rates to include greater detail where it has deemed that certain inputs to the rate are complex enough to warrant prior understanding of their effect.
50. As described above in the proposal for return of excess ADIT or recovery of deficient ADIT, we believe that the Commission's existing regulations require public utilities with transmission stated rates to provide sufficient support for any proposed tax-related changes. As a result, we do not propose any additional information requirements for public utilities with transmission stated rates.
51. We propose to require each public utility with transmission stated or formula rates to submit a compliance filing within 90 days of the effective date of any subsequent final rule in this proceeding to revise its transmission formula or stated rates, as necessary, to demonstrate that it meets the requirements set forth in any subsequent final rule.
52. Some public utilities with transmission formula rates may already have mechanisms in place in their rates that address the issues and concerns addressed by any subsequent final rule. Where these provisions would be modified by any subsequent final rule, the public utility must either comply with any subsequent final rule or demonstrate that these previously approved variations continue to be consistent with or superior to the requirements of any subsequent final rule.
53. The Commission will assess whether each compliance filing satisfies the proposed requirements stated above and issue additional orders as necessary to ensure that each public utility with transmission stated or formula rates meets the requirements of the subsequent final rule.
54. The collection of information contained in this Proposed Rule is subject to review by the Office of Management and Budget (OMB) regulations under section 3507(d) of the Paperwork Reduction Act of 1995 (PRA).
55. The reforms proposed in this Proposed Rule address public utilities that have transmission formula rates and transmission stated rates. The reforms related to transmission formula rates represent new requirements for these entities under the Commission's regulations in 18 CFR 35.24, which we believe are necessary because of the dramatic changes in the rate structure of the electric transmission industry since this provision was originally promulgated in 1981.
56. The reforms required by this Proposed Rule will require each public utility with stated rates to calculate the excess and deficient ADIT caused by the Tax Cuts and Jobs Act and to return to or recover from customers those amounts. This reform is intended to increase the likelihood that customers who contributed to the excess ADIT balance timely receive the benefits of the Tax Cuts and Jobs Act.
57. The reforms proposed in this Proposed Rule would require compliance filings with the Commission by each public utility with transmission stated or formula rates to allow the Commission the opportunity to determine whether each such public utility met the requirements detailed in this Proposed Rule.
58. We anticipate the reforms proposed in this Proposed Rule, once implemented, would not significantly change currently existing burdens on an ongoing basis. With regard to those public utilities with transmission stated or formula rates that believe that they already comply with the reforms proposed in this Proposed Rule, they could demonstrate their compliance in the filing required 90 days after the effective date of the final revision in this proceeding. We will submit the proposed reporting requirements to OMB for its review and approval under section 3507(d) of the Paperwork Reduction Act.
59. While we expect the adoption of the reforms proposed in this Proposed Rule to provide significant benefits, the Commission understands that implementation can be a complex and costly endeavor. We solicit comments on the accuracy of provided burden and cost estimates and any suggested methods for minimizing the respondents' burdens.
60.
Accountant (Occupation Code: 13-2011): $56.59.
Management (Occupation Code: 11-0000): $94.28.
Legal (Occupation Code: 23-0000): $143.68.
Office and Administrative Support (Occupation Code: 43-0000): $41.34.
These various occupational categories' wage figures are averaged and weighted equally as follows: ($94.28/hour + $61.55/hour + $66.90/hour + $143.68/hour) ÷ 4 = $91.60/hour. The resulting wage figure is rounded to $92.00/hour for use in calculating wage figures in the NOPR in Docket No. RM19-5-000.
•
•
After Year 1, the reforms proposed in this Proposed Rule, once implemented, would not significantly change existing burdens on an ongoing basis.
61. Interested persons may obtain information on the reporting requirements by contacting the following: Federal Energy Regulatory Commission, 888 First Street, NE, Washington, DC 20426 [Attention: Ellen Brown, Office of the Executive Director], email:
62. We are required to prepare an Environmental Assessment or an Environmental Impact Statement for any action that may have a significant adverse effect on the human environment.
63. The Regulatory Flexibility Act of 1980 (RFA)
64. The Small Business Administration (SBA) revised its size standards (effective January 22, 2014) for electric utilities from a standard based on megawatt hours to a standard based on the number of employees, including affiliates. Under SBA's standards, some transmission owners will fall under the following category and associated size threshold: Electric bulk power transmission and control, at 500 employees.
65. We estimate that the total number of public utility transmission providers with formula rates that would have to develop revisions to their formula rates, including the addition of a new permanent worksheet, and make compliance filings in response to this Proposed Rule is 106. Of these, we estimate that approximately 43 percent are small entities (approximately 46 entities). We estimate the average total cost to each of these entities will be $5,152 in Year 1 and $0 in subsequent years. In addition, we estimate that the total number of public utility transmission providers with stated rates that will have to calculate the excess and deficient income tax to return to or recover from customers is 31. Of these, we estimate that approximately 43 percent are small entities (approximately 13 entities). We estimate the average total cost to each of these entities will be between $1,380 in Year One and $0 in subsequent years. According to SBA guidance, the determination of significance of impact “should be seen as relative to the size of the business, the size of the competitor's business, and the impact the regulation has on larger competitors.”
66. We invite interested persons to submit comments on the matters and issues proposed in this notice to be adopted, including any related matters or alternative proposals that commenters may wish to discuss. Comments are due December 24, 2018. Comments must refer to Docket No. RM19-5-000, and must include the commenter's name, the organization they represent, if applicable, and their address in their comments.
67. The Commission encourages comments to be filed electronically via the eFiling link on the Commission's website at
68. Commenters that are not able to file comments electronically must send an original of their comments to: Federal Energy Regulatory Commission, Secretary of the Commission, 888 First Street NE, Washington, DC, 20426.
69. All comments will be placed in the Commission's public files and may
70. In addition to publishing the full text of this document in the
71. From the Commission'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.
72. User assistance is available for eLibrary and the Commission's website during normal business hours from the Commission's Online Support at 202-502-6652 (toll free at 1-866-208-3676) or email at
By direction of the Commission. Commissioner McIntyre is not voting on this order.
Appendix A will not be published in the
Internal Revenue Service (IRS), Treasury.
Notice of proposed rulemaking and notification of public hearing.
This document contains proposed regulations addressing the effect of recent legislative changes to the basic exclusion amount used in computing Federal gift and estate taxes. The proposed regulations will affect donors of gifts made after 2017 and the estates of decedents dying after 2017.
Written and electronic comments must be received by February 21, 2019. Outlines of topics to be discussed at the public hearing scheduled for March 13, 2019, must be received by February 21, 2019. If no outlines of topics are received by February 21, 2019, the hearing will be cancelled.
Send submissions to: CC:PA:LPD:PR (REG-106706-18), Room 5203, Internal Revenue Service, P.O. Box 7604, Ben Franklin Station, Washington, DC 20044. Submissions also may be hand delivered Monday through Friday between the hours of 8 a.m. and 5 p.m. to: CC:PA:LPD:PR (REG-106706-18), Courier's Desk, Internal Revenue Service, 1111 Constitution Avenue NW, Washington, DC 20224, or sent electronically via the Federal eRulemaking portal at
Concerning the proposed regulations, Deborah S. Ryan, (202) 317-6859; concerning submissions of comments, the hearing, and/or to be placed on the building access list to attend the hearing, Regina L. Johnson at (202) 317-6901 (not toll-free numbers).
In computing the amount of Federal gift tax to be paid on a gift or the amount of Federal estate tax to be paid at death, the gift and estate tax provisions of the Internal Revenue Code (Code) apply a unified rate schedule to the taxpayer's cumulative taxable gifts and taxable estate on death to arrive at a net tentative tax. The net tentative tax then is reduced by a credit based on the applicable exclusion amount (AEA), which is the sum of the basic exclusion amount (BEA) within the meaning of section 2010(c)(3) of the Code and, if applicable, the deceased spousal unused exclusion (DSUE) amount within the meaning of section 2010(c)(4). In certain cases, the AEA also includes a restored exclusion amount pursuant to Notice 2017-15, 2017-6 I.R.B. 783. Prior to January 1, 2018, for estates of decedents dying and gifts made beginning in 2011, section 2010(c)(3) provided a BEA of $5 million, indexed for inflation after 2011. The credit is applied first against the gift tax, on a cumulative basis, as taxable gifts are made. To the extent that any credit remains at death, it is applied against the estate tax.
This document contains proposed regulations to amend the Estate Tax Regulations (26 CFR part 20) under section 2010(c)(3) of the Code. The proposed regulations would update § 20.2010-1 to conform to statutory changes to the determination of the BEA enacted on December 22, 2017, by sections 11002 and 11061 of the Tax Cuts and Jobs Act, Public Law 115-97, 131 Stat. 2504 (2017) (TCJA).
The Federal gift tax is imposed by section 2501 of the Code on an individual's transfers by gift during each calendar year. The gift tax is determined under a seven-step computation required under sections 2502 and 2505 using the rate schedule set forth in section 2001(c) as in effect for the calendar year in which the gifts are made.
First, section 2502(a)(1) requires the determination of a tentative tax (that is, a tax unreduced by a credit amount) on the sum of all taxable gifts, whether made in the current year or in one or more prior periods (Step 1).
Second, section 2502(a)(2) requires the determination of a tentative tax on the sum of the taxable gifts made in all prior periods (Step 2).
Third, section 2502(a) requires the tentative tax determined in Step 2 to be subtracted from the tentative tax determined in Step 1 to arrive at the net tentative gift tax on the gifts made in the current year (Step 3).
Fourth, section 2505(a)(1) requires the determination of a credit equal to the applicable credit amount within the meaning of section 2010(c). The applicable credit amount is the tentative tax on the AEA determined as if the donor had died on the last day of the current calendar year. The AEA is the sum of the BEA as in effect for the year in which the gift was made, any DSUE amount as of the date of the gift as computed pursuant to § 25.2505-2, and any restored exclusion amount as of the date of the gift as computed pursuant to Notice 2017-15 (Step 4).
Fifth, section 2505(a)(2) and the flush language at the end of section 2505(a) require the determination of the sum of the amounts allowable as a credit to offset the gift tax on gifts made by the donor in all preceding calendar periods. For purposes of this determination, the allowable credit for each preceding calendar period is the tentative tax, computed at the tax rates in effect for the current period, on the AEA for such prior period, but not exceeding the tentative tax on the gifts actually made during such prior period. Section 2505(c). (Step 5).
Sixth, section 2505(a) requires that the total credit allowable for prior periods determined in Step 5 be subtracted from the credit for the current period determined in Step 4. (Step 6).
Finally, section 2505(a) requires that the credit amount determined in Step 6 be subtracted from the net tentative gift tax determined in Step 3 (Step 7).
The Federal estate tax is imposed by section 2001(a) on the transfer of a decedent's taxable estate at death. The estate tax is determined under a five-step computation required under sections 2001 and 2010 using the same rate schedule used for gift tax purposes (thus referred to as the unified rate schedule) as in effect at the decedent's death.
First, section 2001(b)(1) requires the determination of a tentative tax (again, a tax unreduced by a credit amount) on the sum of the taxable estate and the adjusted taxable gifts, defined as all taxable gifts made after 1976 other than those included in the gross estate (Step 1).
Second, section 2001(b)(2) and (g) require the determination of a hypothetical gift tax (a gift tax reduced, but not to below zero, by the credit amounts allowable in the years of the gifts) on all post-1976 taxable gifts, whether or not included in the gross estate. The credit amount allowable for each year during which a gift was made is the tentative tax, computed using the tax rates in effect at the decedent's death, on the AEA for that year, but not exceeding the tentative tax on the gifts made during that year. Section 2505(c). The AEA is the sum of the BEA as in effect for the year in which the gift was made, any DSUE amount as of the date of the gift as computed pursuant to § 25.2505-2, and any restored exclusion amount as of the date of the gift as computed pursuant to Notice 2017-15. This hypothetical gift tax is referred to as the gift tax payable (Step 2).
Third, section 2001(b) requires the gift tax payable determined in Step 2 to be subtracted from the tentative tax determined in Step 1 to arrive at the net tentative estate tax (Step 3).
Fourth, section 2010(a) and (c) require the determination of a credit equal to the tentative tax on the AEA as in effect on the date of the decedent's death. This credit may not exceed the net tentative estate tax. Section 2010(d). (Step 4).
Finally, section 2010(a) requires that the credit amount determined in Step 4 be subtracted from the net tentative estate tax determined in Step 3. (Step 5).
Section 11061 of the TCJA amended section 2010(c)(3) to provide that, for decedents dying and gifts made after December 31, 2017, and before January 1, 2026, the BEA is increased by $5 million to $10 million as adjusted for inflation (increased BEA). On January 1, 2026, the BEA will revert to $5 million. Thus, an individual or the individual's estate may utilize the increased BEA to shelter from gift and estate taxes an additional $5 million of transfers made during the eight-year period beginning on January 1, 2018, and ending on December 31, 2025 (increased BEA period).
In addition, section 11002 of the TCJA amended section 1(f)(3) of the Code to base the determination of annual cost-of-living adjustments, including those for gift and estate tax purposes, on the Chained Consumer Price Index for All Urban Consumers for all taxable years beginning after December 31, 2017. Section 11002 of the TCJA also made conforming changes in sections 2010(c)(3)(B)(ii), 2032A(a)(3)(B), and 2503(b)(2)(B).
Section 11061 of the TCJA also added section 2001(g)(2) to the Code, which, in addition to the necessary or appropriate regulatory authority granted in section 2010(c)(6) for purposes of section 2010(c), directs the Secretary to prescribe such regulations as may be necessary or appropriate to carry out section 2001 with respect to any difference between the BEA applicable at the time of the decedent's death and the BEA applicable with respect to any gifts made by the decedent.
Given the cumulative nature of the gift and estate tax computations and the differing manner in which the credit is applied against these two taxes, commenters have raised two questions regarding a potential for inconsistent tax treatment or double taxation of transfers resulting from the temporary nature of the increased BEA. First, in cases in which a taxpayer exhausted his or her BEA and paid gift tax on a pre-2018 gift, and then either makes an additional gift or dies during the increased BEA period, will the increased BEA be absorbed by the pre-2018 gift on which gift tax was paid so as to deny the taxpayer the full benefit of the increased BEA during the increased BEA period? Second, in cases in which a taxpayer
As discussed in the remainder of this Background section, the Treasury Department and the IRS have analyzed the statutorily required steps for determining Federal gift and estate taxes in the context of several different situations that could occur either during the increased BEA period as a result of an increase in the BEA, or thereafter as a result of a decrease in the BEA. Only in the last situation discussed below was a potential problem identified, and a change intended to correct that problem is proposed in this notice of proposed rulemaking. This preamble, however, also includes a brief explanation of the reason why no potential problem is believed to exist in any of the first three situations discussed below. For the sake of simplicity, the following discussion assumes that, as may be the more usual case, the AEA includes no DSUE or restored exclusion amount and thus, refers only to the BEA.
The first situation considered is whether, for gift tax purposes, the increased BEA available during the increased BEA period is reduced by pre-2018 gifts on which gift tax actually was paid. This issue arises for donors, who made both pre-2018 gifts exceeding the then-applicable BEA, thus making gifts that incurred a gift tax liability, and additional gifts during the increased BEA period. The concern raised is whether the gift tax computation will apply the increased BEA to the pre-2018 gifts, thus reducing the BEA otherwise available to shelter gifts made during the increased BEA period and, in effect, allocating credit to a gift on which gift tax in fact was paid.
Step 3 of the gift tax determination requires the tentative tax on all gifts from prior periods to be subtracted from the tentative tax on the donor's cumulative gifts (including the current gift). The gifts from prior periods include the pre-2018 gifts on which gift tax was paid. In this way, the full amount of the gift tax liability on the pre-2018 gifts is removed from the current year gift tax computation, regardless of whether that liability was sheltered from gift tax by the BEA and/or was satisfied by a gift tax payment. Steps 4 through 6 of the gift tax determination then require, in effect, that the BEA for the current year be reduced by the BEA allowable in prior periods against the gifts that were made by the donor in those prior periods. The increased BEA was not available in the years when the pre-2018 gifts were made and thus, was not allowable against those gifts. Accordingly, the gift tax determination appropriately reduces the increased BEA only by the amount of BEA allowable against prior period gifts, thereby ensuring that the increased BEA is not reduced by a prior gift on which gift tax in fact was paid.
The second situation considered is whether, for estate tax purposes, the increased BEA available during the increased BEA period is reduced by pre-2018 gifts on which gift tax actually was paid. This issue arises in the context of estates of decedents who both made pre-2018 gifts exceeding the then allowable BEA, thus making gifts that incurred a gift tax liability, and die during the increased BEA period. The concern raised is whether the estate tax computation will apply the increased BEA to the pre-2018 gifts, thus reducing the BEA otherwise available against the estate tax during the increased BEA period and, in effect, allocating credit to a gift on which gift tax in fact was paid.
Step 3 of the estate tax determination requires that the hypothetical gift tax on the decedent's post-1976 taxable gifts be subtracted from the tentative tax on the sum of the taxable estate and adjusted taxable gifts. The post-1976 taxable gifts include the pre-2018 gifts on which gift tax was paid. In this way, the full amount of the gift tax liability on the pre-2018 gifts is removed from the estate tax computation, regardless of whether that liability was sheltered from gift tax by the BEA and/or was satisfied by a gift tax payment. Step 4 of the estate tax determination then requires that a credit on the amount of the BEA for the year of the decedent's death be subtracted from the net tentative estate tax. As a result, the only time that the increased BEA enters into the computation of the estate tax is when the credit on the amount of BEA allowable in the year of the decedent's death is netted against the tentative estate tax, which in turn already has been reduced by the hypothetical gift tax on the full amount of all post-1976 taxable gifts (whether or not gift tax was paid). Thus, the increased BEA is not reduced by the portion of any prior gift on which gift tax was paid, and the full amount of the increased BEA is available to compute the credit against the estate tax.
The third situation considered is whether the gift tax on a gift made after the increased BEA period is inflated by a theoretical gift tax on a gift made during the increased BEA period that was sheltered from gift tax when made. If so, this would effectively reverse the benefit of the increased BEA available for gifts made during the increased BEA period. This issue arises in the case of donors who both made one or more gifts during the increased BEA period that were sheltered from gift tax by the increased BEA in effect during those years, and made a post-2025 gift. The concern raised is whether the gift tax determination on the post-2025 gift will treat the gifts made during the increased BEA period as gifts not sheltered from gift tax by the credit on the BEA, given that the post-2025 gift tax determination is based on the BEA then in effect, rather than on the increased BEA.
Just as in the first situation considered in part V(2) of this Background section, Step 3 of the gift tax determination directs that the tentative tax on gifts from prior periods be subtracted from the tentative tax on the donor's cumulative gifts (including the current gift). The gift tax from prior periods includes the gift tax attributable to the gifts made during the increased BEA period. In this way, the full amount of the gift tax liability on the increased BEA period gifts is removed from the computation, regardless of whether that liability was sheltered from gift tax by the BEA or was satisfied by a gift tax payment. All that remains is the tentative gift tax on the donor's current gift. Steps 4 through 6 of the gift tax determination then require that the credit based on the BEA for the current year be reduced by such credits allowable in prior periods. Even if the sum of the credits allowable for prior periods exceeds the credit based on the BEA in the current (post-2025) year, the tax on the current gift cannot exceed the tentative tax on that gift and thus will not be improperly inflated. The gift tax determination anticipates and avoids this situation, but no credit will be available against the tentative tax on the post-2025 gift.
The fourth situation considered is whether, for estate tax purposes, a gift made during the increased BEA period that was sheltered from gift tax by the increased BEA inflates a post-2025 estate tax liability. This will be the case
In this case, the statutory requirements for the computation of the estate tax, in effect, retroactively eliminate the benefit of the increased BEA that was available for gifts made during the increased BEA period. This can be illustrated by the following examples.
Individual A made a gift of $11 million in 2018, when the BEA was $10 million. A dies in 2026, when the BEA is $5 million, with a taxable estate of $4 million. Based on a literal application of section 2001(b), the estate tax would be approximately $3,600,000, which is equal to a 40 percent estate tax on $9 million (specifically, the $9 million being the sum of the $4 million taxable estate and $5 million of the 2018 gift sheltered from gift tax by the increased BEA). This in effect would impose estate tax on the portion of the 2018 gift that was sheltered from gift tax by the increased BEA allowable at that time.
The facts are the same as in
This problem occurs as a result of the interplay between Steps 2 and 4 of the estate tax determination, and the differing amounts of BEA taken into account in those steps. Step 2 determines the credit against gift taxes payable on all post-1976 taxable gifts, whether or not included in the gross estate, using the BEA amounts allowable on the dates of the gifts but determined using date of death tax rates. Step 3 subtracts gift tax payable from the tentative tax on the sum of the taxable estate and the adjusted taxable gifts. The result is the net tentative estate tax. Step 4 determines a credit based on the BEA as in effect on the date of the decedent's death. Step 5 then reduces the net tentative estate tax by the credit determined in Step 4. If the credit amount applied at Step 5 is less than that allowable for the decedent's post-1976 taxable gifts at Step 2, the effect is to increase the estate tax by the difference between those two credit amounts. In this circumstance, the statutory requirements have the effect of imposing an estate tax on gifts made during the increased BEA period that were sheltered from gift tax by the increased BEA in effect when the gifts were made.
To implement the TCJA changes to the BEA under section 2010(c)(3), the proposed regulations would amend § 20.2010-1 to provide that, in the case of decedents dying or gifts made after December 31, 2017, and before January 1, 2026, the increased BEA is $10 million. The proposed regulations also would conform the rules of § 20.2010-1 to the changes made by the TCJA regarding the cost of living adjustment.
Pursuant to section 2001(g)(2), the proposed regulations also would amend § 20.2010-1 to provide a special rule in cases where the portion of the credit as of the decedent's date of death that is based on the BEA is less than the sum of the credit amounts attributable to the BEA allowable in computing gift tax payable within the meaning of section 2001(b)(2). In that case, the portion of the credit against the net tentative estate tax that is attributable to the BEA would be based upon the greater of those two credit amounts. In the view of the Treasury Department and the IRS, the most administrable solution would be to adjust the amount of the credit in Step 4 of the estate tax determination required to be applied against the net tentative estate tax. Specifically, if the total amount allowable as a credit, to the extent based solely on the BEA, in computing the gift tax payable on the decedent's post-1976 taxable gifts, whether or not included in the gross estate, exceeds the credit amount, again to the extent based solely on the BEA in effect at the date of death, the Step 4 credit would be based on the larger amount of BEA. As modified, Step 4 of the estate tax determination therefore would require the determination of a credit equal to the tentative tax on the AEA as in effect on the date of the decedent's death, where the BEA included in that AEA is the larger of (i) the BEA as in effect on the date of the decedent's death under section 2010(c)(3), or (ii) the total amount of the BEA allowable in determining Step 2 of the estate tax computation (that is, the gift tax payable).
For example, if a decedent had made cumulative post-1976 taxable gifts of $9 million, all of which were sheltered from gift tax by a BEA of $10 million applicable on the dates of the gifts, and if the decedent died after 2025 when the BEA was $5 million, the credit to be applied in computing the estate tax is that based upon the $9 million of BEA that was used to compute gift tax payable.
The proposed regulations ensure that a decedent's estate is not inappropriately taxed with respect to gifts made during the increased BEA period. Congress' grant of regulatory authority in section 2001(g)(2) to address situations in which differences exist between the BEA applicable to a decedent's gifts and the BEA applicable to the decedent's estate clearly permits the Secretary to address the situation in which a gift is made during the increased BEA period and the decedent dies after the increased BEA period ends.
Commenters have noted that this problem is similar to that involving the application of the AEA addressed in the DSUE regulations. Section 20.2010-3(b). The DSUE amount generally is what remains of a decedent's BEA that can be used to offset the gift and/or estate tax liability of the decedent's surviving spouse. At any given time, however, a surviving spouse may use only the DSUE amount from his or her last deceased spouse—thus, only until the death of any subsequent spouse. Without those regulations, if a DSUE amount was used to shelter a surviving spouse's gifts from gift tax before the death of a subsequent spouse, and if the surviving spouse also survived the subsequent spouse, those gifts would have had the effect of absorbing the DSUE amount available to the surviving spouse at death, effectively resulting in a taking back of the DSUE amount that had been allocated to the earlier gifts. The DSUE regulations resolve this problem by providing that the DSUE amount available at the surviving spouse's death is the sum of the DSUE amount from that spouse's last deceased spouse, and any DSUE amounts from other deceased spouses that were “applied to one or more taxable gifts” of the surviving spouse.
The amendment to § 20.2010-1 is proposed to be effective on and after the date of publication of a Treasury decision adopting these rules as final regulations in the
These proposed regulations are not subject to review under section 6(b) of Executive Order 12866 pursuant to the Memorandum of Agreement (April 11, 2018) between the Treasury Department and the Office of Management and Budget regarding review of tax regulations.
Pursuant to the Regulatory Flexibility Act (5 U.S.C. chapter 6), it is hereby certified that these proposed regulations will not have a significant economic impact on a substantial number of small entities. These proposed regulations apply to donors of gifts made after 2017 and to the estates of decedents dying after 2017, and implement an increase in the amount that is excluded from gift and estate tax. Neither an individual nor the estate of a deceased individual is a small entity within the meaning of 5 U.S.C. 601(6). Accordingly, a regulatory flexibility analysis is not required.
Pursuant to section 7805(f) of the Internal Revenue Code, this regulation has been submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.
Before these proposed regulations are adopted as final regulations, consideration will be given to any written or electronic comments that are submitted timely (in the manner described under the
The rules of 26 CFR 601.601(a)(3) apply to the hearing. Persons who wish to present oral comments at the hearing must submit comments by February 21, 2019, and submit an outline of the topics to be discussed and the time devoted to each topic by February 21, 2019.
A period of 10 minutes will be allotted to each person for making comments. Copies of the agenda will be available free of charge at the hearing.
The principal author of these proposed regulations is Deborah S. Ryan, Office of the Associate Chief Counsel (Passthroughs and Special Industries). Other personnel from the Treasury Department and the IRS participated in their development.
Notice 2017-15 is published in the Internal Revenue Bulletin (or Cumulative Bulletin) and is available from the Superintendent of Documents, U.S. Government Publishing Office, Washington, DC 20402, or by visiting the IRS website at
Estate taxes, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 20 is proposed to be amended as follows:
26 U.S.C. 7805.
Section 20.2010-1 also issued under 26 U.S.C. 2001(g)(2) and 26 U.S.C. 2010(c)(6).
The addition and revisions read as follows:
(c)
(2)
(e) * * *
(3)
(i) For any decedent dying in calendar year 2011 or thereafter, $5,000,000; and
(ii) For any decedent dying after calendar year 2011, $5,000,000 multiplied by the cost-of-living adjustment determined under section 1(f)(3) for the calendar year of decedent's death by substituting “calendar year 2010” for “calendar year 2016” in section 1(f)(3)(A)(ii) and rounded to the nearest multiple of $10,000.
(iii) In the case of the estates of decedents dying after December 31, 2017, and before January 1, 2026, paragraphs (e)(3)(i) and (ii) of this section will be applied by substituting “$10,000,000” for “$5,000,000.”
(f)
(2)
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve two submissions from the Missouri Department of Natural Resources (MoDNR) revising the State Implementation Plan (SIP) for the State of Missouri. The SIP revision submissions address the Clean Air Act (CAA) section 172 requirement to submit a base year emissions inventory for Missouri's partial Jackson County and partial Jefferson County nonattainment areas of the 2010 1-hour Sulfur Dioxide (SO
Comments must be received on or before December 24, 2018.
You may send comments, identified by Docket ID No. EPA-R07-OAR-2018-0700 to
Tracey Casburn, Environmental Protection Agency, Air Planning and Development Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219, by telephone at (913) 551-7016, or by email at
Throughout this document “we,” “us,” and “our” refer to the EPA.
Submit your comments, identified by Docket ID No. EPA-R07-OAR-2018-0700, at
On June 22, 2010, the EPA promulgated a new 1-hour primary SO
CAA section 172(c)(3) requires states to develop and submit a comprehensive, accurate, current emissions inventory for all areas designated as nonattainment. An emissions inventory is an estimation of actual emissions of air pollutants in an area that provides data for a variety of air quality planning tasks including establishing baseline emission levels, calculating Federally required emission reduction targets, emission inputs into air quality simulation models, and for tracking emissions over time. The EPA's April 2014 guidance document “Guidance for 1-Hour SO
The EPA has reviewed the state's emission inventory SIP revision submissions and is proposing to approve the SIP revision submissions pursuant to sections 110, 191(a), and 172(c)(3) of the CAA.
The baseline emissions inventory for the Jackson County SO
The baseline emissions inventory for the Jefferson County SO
None of the comments the state received were directly related to the baseline year emissions inventories, therefore no changes were made to the baseline emmisions inventories prior to submitting the SIP revision submissions to the EPA. The emissions inventory SIP revision submissions meet the procedural requirements for SIP submittals in the CAA, including section 110 and implementing regulations.
The baseline emissions inventory in both SIP revision submissions was taken from the 2011 National Emissions Inventory (NEI) database. The MoDNR developed a comprehensive statewide emissions inventory for 2011 as required by the EPA's Air Emissions Reporting Requirements (AERR) rule. See 73 FR 76539 codified at 40 CFR 51.1-51.50. The inventory was submitted to the NEI through the EPA's Emission Inventory System (EIS). The 2011 baseline emissions inventory in both SIP revision submissions included point, area (or nonpoint), and mobile emissions sources of SO
The EPA is proposing to approve the two SIP revision submissions from the MoDNR addressing the CAA section 172(c)(3) requirement to submit a base year emissions inventory for Missouri's partial Jackson County and partial Jefferson County nonattainment areas of the 2010 1-hour SO
Under the Clean Air Act (CAA), the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of the National Technology Transfer and Advancement Act (NTTA) because this rulemaking does not involve technical standards; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian
Environmental protection, Air pollution control, Emissions Inventory, Incorporation by reference, Sulfur oxides.
For the reasons stated in the preamble, the EPA proposes to amend part 52 as set forth below:
42 U.S.C. 7401
(e) * * *
Environmental Protection Agency (EPA).
Proposed rule.
On April 20, 2018, the State of Arkansas (AR), through the Arkansas Department of Environmental Quality (ADEQ) submitted a request for the Environmental Protection Agency (EPA) to assess new available information and redesignate the Independence County, AR unclassifiable area (hereinafter referred to as the “County” or “Area”) for the 2010 sulfur dioxide (SO
Comments must be received on or before December 24, 2018.
Submit your comments, identified by Docket ID No. EPA-R06-OAR-2018-0624 at
Mr. Ruben Casso, (214) 665-6763,
Throughout this document “we,” “us,” or “our” means the EPA.
The Clean Air Act (CAA or Act) establishes a process for air quality management through the establishment and implementation of the NAAQS. After the promulgation of a new or revised NAAQS, EPA is required to designate all areas of the country, pursuant to section 107(d)(1) of the CAA. For the 2010 SO
Entergy Corporation Independence Steam Electric Station (Independence Station). Independence Station is located in northeastern Arkansas in the eastern portion of Independence County, approximately 5 kilometers (km) southeast of Newark, Arkansas. Independence Station is a large Electrical Generating Unit that was included in the list of facilities to be designated pursuant to a March 2, 2015 Consent Decree.
Independence County was designated unclassifiable on July 12, 2016.
Detailed rationale, analyses, and other information supporting our original designation for this area can be found in the final action's technical support document for Arkansas.
Section 107(d)(3)(A) provides that the Administrator may notify the Governor of any state that the designation of an area should be revised “on the basis of air quality data, planning and control considerations, or any other air quality-related considerations the Administrator deems appropriate.” The Act further provides in section 107(d)(3)(D) that even if the Administrator has not notified a state Governor that a designation should be revised, the Governor of any state may, on the Governor's own motion, submit a request to revise the designation of any area, and the Administrator must approve or deny the request.
When approving or denying a request to redesignate an area, the EPA bases its decision on the air quality data for the area as well as the considerations provided under section 107(d)(3)(A).
Independence County was designated unclassifiable by the EPA on July 12, 2016. As discussed previously, modeling results provided by Arkansas and Sierra Club in 2015 and 2016 were not refined enough to make a clear determination of the area's attainment status. Since that designation, the EPA has worked with ADEQ and the two facilities in refining the modeling approaches and inputs resulting in modeling that is acceptable for assessing whether the area is attaining or not attaining the 1-hour SO
According to the EPA's guidance on redesignations, SO
The EPA has reviewed the modeling provided by the state with their redesignation request and finds that it comports with the EPA's, current Modeling TAD
The EPA is proposing to approve Arkansas' April 20, 2018, request to change the EPA's previous designation and redesignate Independence County from unclassifiable to attainment/unclassifiable for the 2010 SO
Under the CAA, redesignation of an area to attainment/unclassifiable is an action that affects the status of a geographical area and does not impose any additional regulatory requirements on sources beyond those imposed by state law. A redesignation to attainment/unclassifiable does not in and of itself create any new requirements. Accordingly, this proposed action merely proposes to redesignate an area to attainment/unclassifiable and does not impose additional requirements. For that reason, this proposed action:
• Is exempt from review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because it is exempt under Executive Order 12866;
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is not subject to the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4);
• is not subject because it does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it does not establish an environmental standard intended to mitigate health or safety risks;
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because this action does not involve technical standards;
• will not have disproportionate human health or environmental effects under Executive Order 12898 (59 FR 7629, February 16, 1994); and
• does not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000) because no tribal lands are located within the Area and the redesignation does not create new requirements. The EPA notes this proposed action will not impose substantial direct costs on Tribal governments or preempt Tribal law.
Environmental protection, Air pollution control, National parks, Wilderness areas.
42 U.S.C. 7401
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Advance notice of proposed rulemaking (ANPRM); extension of comment period.
In response to a request from the public, NHTSA is announcing a two-week extension of the comment period on the ANPRM on a Pilot Program for Collaborative Research on Motor Vehicles with High or Full Driving Automation. The comment period for the ANPRM was originally scheduled to end on November 26, 2018. It will now end on December 10, 2018.
The comment period for the ANPRM published on October 10, 2018 at 83 FR 50872 is extended. Written comments on the ANPRM must be received on or before December 10, 2018 in order to be considered timely.
Comments must be submitted by one of the following methods:
•
•
•
•
Regardless of how you submit your comments, they must include the docket number identified in the heading of this notice.
Note that all comments received, including any personal information provided, will be posted without change to
You may call the Docket Management Facility at 202-366-9324.
For research and pilot program issues: Dee Williams, Office of Vehicle Safety Research, 202-366-8537,
For legal issues: Stephen Wood, Assistant Chief Counsel, Vehicle Rulemaking and Harmonization, Office of Chief Counsel, 202-366-2992,
On October 10, 2018, NHTSA published an ANPRM to obtain public comments on the factors and structure that are appropriate for the Agency to consider in designing a national pilot program that will enable the Agency to facilitate, monitor and learn from the testing and development of the emerging advanced vehicle safety technologies and to assure the safety of those activities. The ANPRM stated that the closing date for comments is November 26, 2018.
On November 16, 2018, NHTSA received a request from the Uber Technologies, Inc. for a two-week extension of the comment period. The request can be found in the docket for the ANPRM listed above under
Animal and Plant Health Inspection Service, Department of Agriculture.
30-Day notice of submission of information collection approval from the Office of Management and Budget and request for comments.
As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, the Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS) has submitted a Generic Information Collection Request (Generic ICR): “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery” to OMB for approval under the Paperwork Reduction Act (PRA).
Comments must be submitted December 24, 2018.
Written comments may be submitted to the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503;
To request additional information, please contact Ruth Brown (202) 720-8958.
Feedback collected under this generic clearance will provide useful information, but it will not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non-response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results.
The Agency received one comment in response to the 60-day notice published in the
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 Office of Management and Budget control number.
The Department of Agriculture has submitted the following information collection requirement(s) to Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological
Comments regarding this information collection received by December 24, 2018 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725—17th Street NW, Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to:
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments regarding this information collection received by December 24, 2018 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th Street NW, Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to:
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Animal and Plant Health Inspection Service, USDA.
Extension of approval of an information collection; comment request.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with training related to animal diseases.
We will consider all comments that we receive on or before January 22, 2019.
You may submit comments by either of the following methods:
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•
Supporting documents and any comments we receive on this docket may be viewed at
For information on training related to animal diseases, contact Ms. Alicia D. Love, Program Specialist, Professional Development Services Branch, VS, APHIS, 4700 River Road, Unit 27, Riverdale, MD 20737; (301) 851-3425. For more detailed information on the information collection, contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483.
Individuals who wish to attend animal disease-related training must submit a Nomination Request Form (VS Form 1-5) to VS to help the program coordinate courses and select participants. VS develops rosters with course participants' names and contact information to notify them of future training courses and to encourage contact among participants throughout their careers.
We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities for an additional 3 years.
The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:
(1) Evaluate whether the 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 our estimate of the burden of the 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, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies;
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.
National Agricultural Statistics Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 this notice announces the intention of the National Agricultural Statistics Service (NASS) to seek approval to conduct a new information collection to gather economic data from a sample of homeowners, golf courses, sod producers, turfgrass service providers, and commercial businesses with turfgrass in New Jersey.
Comments on this notice must be received by January 22, 2019 to be assured of consideration.
You may submit comments, identified by docket number 0535-NEW, by any of the following methods:
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Kevin L. Barnes, Associate Administrator, National Agricultural Statistics Service, U.S. Department of Agriculture, (202) 720-4333. Copies of this information collection and related instructions can be obtained without charge from David Hancock, NASS—OMB Clearance Officer, at (202) 690-2388 or at
The Turfgrass Economic Survey program will collect economic information from a sample of homeowners, golf courses, sod producers, turfgrass service providers, and commercial businesses with turfgrass in New Jersey. The results of the data collection will track the turfgrass industry's contribution to the New Jersey economy. All questionnaires included in this information collection will be voluntary. This project is conducted as a cooperative effort with Rutgers University. Funding for this survey is being provided by Rutgers University.
NASS also complies with OMB Implementation Guidance, “Implementation Guidance for Title V of the E-Government Act, Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA),”
All responses to this notice will become a matter of public record and be summarized in the request for OMB approval.
The Lake Charles Harbor and Terminal District, grantee of FTZ 87, submitted a notification of proposed production activity to the FTZ Board on behalf of Driftwood LNG, LLC (Driftwood LNG), located in Sulphur, Louisiana. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on November 16, 2018.
The Driftwood LNG facility is located within Subzone 87G. The facility (currently proposed for construction) will be used for liquified natural gas processing. Pursuant to 15 CFR 400.14(b), FTZ activity would be limited to the specific foreign-status material and specific finished products described in the submitted notification and subsequently authorized by the FTZ Board.
Production under FTZ procedures could exempt Driftwood LNG from customs duty payments on the foreign-status gaseous natural gas (duty-free) used in export production. On its domestic sales, for the foreign-status gaseous natural gas, Driftwood LNG would be able to choose the duty rates during customs entry procedures that apply to: Liquified natural gas and stabilized condensate by-product (duty rates are duty-free and 10 cents/barrel, respectively). Driftwood LNG would be able to avoid duty on the foreign-status material which becomes scrap/waste. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.
The request indicates that gaseous natural gas is subject to special duties under Section 301 of the Trade Act of 1974 (Section 301), depending on the country of origin. The applicable Section 301 decisions require subject merchandise to be admitted to FTZs in privileged foreign status (19 CFR 146.41).
Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is January 2, 2019.
A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230-0002, and in the “Reading Room” section of the Board's website, which is accessible via
For further information, contact Diane Finver at
The City of San Jose, California, grantee of FTZ 18, submitted a notification of proposed production activity to the FTZ Board on behalf of Bloom Energy Corporation (Bloom), located at sites in Sunnyvale and Mountain View, California. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on November 15, 2018.
The Bloom facility is located within Subzone 18I. The facility is used for the production of commercial fuel cells and related subassemblies. Pursuant to 15 CFR 400.14(b), FTZ activity would be limited to the specific foreign-status materials and components and specific finished products described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.
Production under FTZ procedures could exempt Bloom from customs duty payments on the foreign-status components used in export production. On its domestic sales, for the foreign-status materials/components noted below, Bloom would be able to choose the duty rates during customs entry procedures that apply to: Piping manifolds; water distribution modules; fuel processing units; fuel cell power modules (DC generators); nickel iron alloy fuel cell power module enclosures (housings); power inverters; and, energy storage and distribution modules (duty rates range from duty-free to 3.8%). Bloom would be able to avoid duty on foreign-status components which become scrap/waste. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.
The components and materials sourced from abroad include: Glass powder; ceramic substrates; plastic labels; plastic containers with sleeves; plastic enclosure bags; plastic cable ties; rubber grommets; adhesives; cardboard boxes; textile paper filters; zirconia alumina shaping stones; ceramic heat plating; glass fiber insulation jackets; nickel alloy wire probes; alloy steel adapters; stainless steel tubing; stainless steel coated tubing; stainless steel
Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is January 2, 2019.
A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230-0002, and in the “Reading Room” section of the Board's website, which is accessible via
For further information, contact Diane Finver at
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Applicable November 23, 2018.
The Department of Commerce (Commerce) is commencing a proceeding to gather information, analyze record evidence, and consider the determinations which would be necessary to bring its measures into conformity with the recommendations and rulings of the Dispute Settlement Body (DSB) of the World Trade Organization (WTO) in
Erin Kearney, AD/CVD Operations Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0167.
On February 9, 2018, the United States informed the DSB that the United States intends to implement the DSB's recommendations and rulings in
In accordance with section 129(b)(1) of the URAA, Commerce consulted with the Office of the United States Trade Representative, and on November 7, 2018, pursuant to those consultations, opened a segment in the AD investigation at issue to commence administrative action to comply with the DSB's recommendations and rulings. The segment will consist of a separate administrative record with its own administrative protective order. In accordance with 19 CFR 351.305(b), interested parties may request access to business proprietary information in this segment of the proceeding in which they are participating. For this Section 129 segment, we may request additional information and we may conduct verification of such information. Consistent with section 129(d) of the URAA, Commerce intends to make a preliminary determination in this Section 129 segment, intends to provide interested parties with an opportunity to provide written comments on the preliminary determination, and may hold a hearing.
In accordance with Commerce's regulations, all submissions to Commerce must be filed electronically using Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). An electronically filed document must be received successfully in its entirety by the time and date it is due. Documents exempted from the electronic submission requirements must be filed manually (
Pursuant to 19 CFR 351.103(d)(l), to be included on the public service list for the Section 129 determination for the aforementioned proceeding, all interested parties, including parties that were part of the public service list in the underlying investigation and any parties otherwise notified of Commerce's commencement of this Section 129 proceeding, must file a letter of appearance. The letter of appearance must be filed separately from any other document (with the exception of an application for administrative protective order (APO) access; parties applying for and granted APO access would automatically be on the public service list). Parties wishing to enter an appearance or submit information with regard to this proceeding must upload their filing(s) to each relevant case number. Additionally, for each submission made in ACCESS, parties must select “S 129-SEC 129” as the segment and enter “DS488” in the segment specific information field.
Unless notified otherwise, the administrative record is closed for submitting new factual information. At this time, Commerce does not intend to seek new factual information in addition to information already on the record of the investigation. If Commerce determines that additional factual information is necessary, it will notify the parties.
Factual information is defined in 19 CFR 351.102(b)(21) as: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by Commerce; and (v) evidence other than factual information described in (i)-(iv). The regulation requires any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted and, if the information is submitted to rebut, clarify, or correct factual information already on the record, to provide an explanation identifying the information already on the record that the factual information seeks to rebut, clarify, or correct. Time limits for the submission of factual information are addressed in 19 CFR 351.301, which provides specific time limits based on the type of factual information being submitted. Parties should review the regulations prior to submitting factual information in this segment.
Parties may request an extension of time limits before the expiration of a time limit established under Part 351, or as otherwise specified by the Secretary. In general, an extension request will be considered untimely if it is filed after the expiration of the time limit established under Part 351 expires. For submissions that are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. Eastern Time on the due date. Under certain circumstances, we may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, we will inform parties in the letter or memorandum setting forth the deadline (including a specified time) by which extension requests must be filed to be considered timely. An extension request must be made in a separate, stand-alone submission; under limited circumstances we will grant untimely-filed requests for the extension of time limits.
Any party submitting factual information in an AD or countervailing duty (CVD) proceeding must certify to the accuracy and completeness of that information.
Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305. On January 22, 2008, Commerce published
This notice is published in accordance with section 129(b)(1) of the URAA.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) is correcting the amended final antidumping duty determination and order for certain oil country tubular
March 26, 2017.
Andrew Huston, 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) 482-4261.
On July 18, 2014, Commerce published its final determination of sales at LTFV and final negative determination of critical circumstances in this proceeding.
In June 2018,
On October 17, 2018, the CIT granted, in part, plaintiff U.S. Steel's motion to enforce the Court's March 16, 2017, order sustaining the remand redetermination by Commerce pertaining to the less-than-fair-value (LTFV) investigation of OCTG from India. Accordingly, Commerce is issuing this notice to correct its earlier amended final determination and amended antidumping duty order with respect to the all-others rate.
We are correcting the
Because there is now a final court decision, Commerce is amending the
Neither
The all-others cash deposit rate, effective March 26, 2017, will be 0.60 percent, the weighted average all-others dumping margin adjusted by the rate of export subsidies determined for all-other producers and exporters in the companion CVD investigation.
We are correcting the
The estimated weighted-average dumping margins are as follows:
This correction to the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
This action serves as a notice that NMFS, on behalf of the Secretary of Commerce (Secretary), has found that the following stocks are subject to overfishing or overfished. Gulf of Mexico gray snapper is now subject to overfishing. Thorny skate is still overfished. NMFS, on behalf of the Secretary, notifies the appropriate regional fishery management council (Council) whenever it determines that overfishing is occurring, a stock is in an overfished condition or a stock is approaching an overfished condition.
Regina Spallone, (301) 427-8568.
Pursuant to section 304(e)(2) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), 16 U.S.C. 1854(e)(2), NMFS, on behalf of the Secretary, must notify Councils, and publish in the
NMFS has determined that the Gulf of Mexico stock of gray snapper is now subject to overfishing. The most recent benchmark assessment for this stock was finalized in 2018, using data through 2015. The assessment supports a determination that the stock is subject to overfishing because the current estimate of fishing mortality (F
NMFS has determined that thorny skate is still overfished. A stock status update was completed for this stock in 2018, using data through 2017. The update supports a determination that the stock remains overfished because the three-year average biomass index (B
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
NOAA has, or is given, authority under the Coastal Zone Management Act (CZMA), annual appropriations or other authorities, to issue funds to coastal states, localities or other recipients for planning, conservation, acquisition, protection, restoration, or construction projects. The required information enables NOAA to implement the CELCP, under its current or future authorization, and facilitate the review of similar projects under different, but related, authorities.
This includes projects funded through:
• The Coastal and Estuarine Land Conservation Program (CZMA Section 307A) to protect important coastal and estuarine areas that have significant conservation, recreation, ecological, historical, or aesthetic values, or that are threatened by conversion, and procedures for eligible applicants who choose to participate in the program to use when developing state conservation plans, proposing or soliciting projects under this program, applying for funds, and carrying out projects under this program in a manner that is consistent with the purposes of the program pursuant to program guidelines which can be found on NOAA's website at:
• the National Estuarine Research Reserve System (CZMA Section 315) Land Acquisition and Construction program;
• the Coastal Zone Management Program's low-cost acquisition and construction program (CZMA Section 306A); or the
• Fish and Wildlife Coordination Act.
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of vendor to provide fishing year 2019 cage tags.
NMFS informs surfclam and ocean quahog individual transferable quota (ITQ) allocation holders that they will be required to purchase their fishing year 2019 (January 1, 2019—December 31, 2019) cage tags from the National Band and Tag Company. The intent of this notice is to comply with regulations for the Atlantic surfclam and ocean quahog fisheries and to promote efficient distribution of cage tags.
Aimee Ahles, Fishery Management Specialist, (978) 281-9373; fax (978) 281-9161.
The Federal Atlantic surfclam and ocean quahog fishery regulations at 50 CFR 648.77(b) authorize the Regional Administrator of the Greater Atlantic Region, NMFS, to specify in the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; request for nominations.
Nominations are being sought for appointment by the Secretary of Commerce to fill vacancies on the Marine Fisheries Advisory Committee (MAFAC or Committee). MAFAC is the only Federal advisory committee with the responsibility to advise the Secretary of Commerce (Secretary) on all matters concerning living marine resources that are the responsibility of the Department of Commerce. The Committee makes recommendations to the Secretary to assist in the development and implementation of Departmental regulations, policies, and programs critical to the mission and goals of NMFS. Nominations are encouraged from all interested parties involved with or representing interests affected by NMFS actions in managing living marine resources. Nominees should possess demonstrable expertise in a field related to the management of living marine resources and be able to fulfill the time commitments required for two annual meetings and year round subcommittee work. Individuals serve for a term of three years for no more than two consecutive terms if re-appointed. NMFS is seeking qualified nominees to fill current vacancies.
Nominations must be postmarked or have an email date stamp on or before December 24, 2018.
Nominations should be sent to Heidi Lovett, MAFAC Assistant Director, NMFS Office of Policy, 14th Floor, 1315 East-West Highway, Silver Spring, MD 20910 or email:
Heidi Lovett, MAFAC Assistant Director; (301) 427-8034; email:
The MAFAC was approved by the Secretary on December 28, 1970, and subsequently chartered under the Federal Advisory Committee Act, 5 U.S.C. App. 2, on February 17, 1971. The Committee meets twice a year with supplementary subcommittee meetings as determined necessary by the Committee Chair and Subcommittee Chairs. No less than 15 and no more than 21 individuals may serve on the Committee. Membership is comprised of highly qualified, diverse individuals representing commercial, recreational, subsistence, and aquaculture fisheries interests; seafood industry; environmental organizations; academic institutions; tribal and consumer groups; and other living marine resource interest groups from a balance of U.S. geographical regions, including the Western Pacific and Caribbean.
A MAFAC member cannot be a Federal employee, member of a Regional Fishery Management Council, registered Federal lobbyist, state employee, or agent of a foreign principal. Selected candidates must pass a security check and submit a financial disclosure form. Membership is voluntary, and except for reimbursable travel and related expenses, service is without pay.
Each nomination submission should include the nominee's name, a cover letter describing the nominee's qualifications and interest in serving on the Committee, curriculum vitae or resume of the nominee, and no more than three supporting letters describing the nominee's qualifications and interest in serving on the Committee. Self-nominations are acceptable. The following contact information should accompany each nominee's submission: Name, address, telephone number, fax number, and email address (if available).
Nominations should be sent to Heidi Lovett (see
United States Patent and Trademark Office, Commerce.
Notice of interim patent term extension.
The United States Patent and Trademark Office has issued an order granting interim extension for a one-year interim extension of the term of U.S. Patent No. 8,311,629.
Mary C. Till by telephone at (571) 272-7755; by mail marked to her attention and addressed to the Commissioner for Patents, Mail Stop Hatch-Waxman PTE, P.O. Box 1450, Alexandria, VA 22313-1450; by fax marked to her attention at (571) 273-7755; or by email to
Section 156 of Title 35, United States Code, generally provides that the term of a patent may be extended for a period of up to five years if the patent claims a product, or a method of making or using a product, that has been subject to certain defined regulatory review, and that the patent may be extended for interim periods of up to one year if the regulatory review is anticipated to extend beyond the expiration date of the patent.
On October 26, 2018, Impulse Dynamic N.V., the patent owner of record, timely filed an application under 35 U.S.C. 156(d)(5) for an interim extension of the term of U.S. Patent No. 8,311,629. The patent claims the medical device, the OPTIMIZER Smart Implantable Pulse Generator. The application for patent term extension indicates that a Premarket Approval Application (PMA) P180036 was submitted to the Food and Drug Administration (FDA) on September 5, 2018.
Review of the patent term extension application indicates that, except for permission to market or use the product commercially, the subject patent would be eligible for an extension of the patent term under 35 U.S.C. 156, and that the patent should be extended for one year as required by 35 U.S.C. 156(d)(5)(B). Because the regulatory review period will continue beyond the original expiration date of the patent, November 16, 2018, interim extension of the patent term under 35 U.S.C. 156(d)(5) is appropriate.
An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 8,311,629 is granted for a period of one year from the original expiration date of the patent.
United States Patent and Trademark Office, Commerce.
Notice of interim patent term extension.
The United States Patent and Trademark Office has issued an order granting interim extension for a one-year interim extension of the term of U.S. Patent No. 8,260,416.
Mary C. Till by telephone at (571) 272-7755; by mail marked to her attention and addressed to the Commissioner for Patents, Mail Stop Hatch-Waxman PTE, P.O. Box 1450, Alexandria, VA 22313-1450; by fax marked to her attention at (571) 273-7755; or by email to
Section 156 of Title 35, United States Code, generally provides that the term of a patent may be extended for a period of up to five years if the patent claims a product, or a method of making or using a product, that has been subject to certain defined regulatory review, and that the patent may be extended for interim periods of up to one year if the regulatory review is anticipated to extend beyond the expiration date of the patent.
On October 26, 2018, Impulse Dynamic N.V., the patent owner of record, timely filed an application under 35 U.S.C. 156(d)(5) for an interim extension of the term of U.S. Patent No. 8,260,416. The patent claims methods of using the medical device, the OPTIMIZER Smart Implantable Pulse Generator. The application for patent term extension indicates that a Premarket Approval Application (PMA) P180036 was submitted to the Food and Drug Administration (FDA) on September 5, 2018.
Review of the patent term extension application indicates that, except for permission to market or use the product commercially, the subject patent would be eligible for an extension of the patent term under 35 U.S.C. 156, and that the patent should be extended for one year as required by 35 U.S.C. 156(d)(5)(B). Because the regulatory review period will continue beyond the original expiration date of the patent, November 19, 2018, interim extension of the patent term under 35 U.S.C. 156(d)(5) is appropriate.
An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 8,260,416 is granted for a period of one year from the original expiration date of the patent.
Department of the Army, DoD.
Notice of open subcommittee meeting.
The Department of the Army is publishing this notice to announce the following Federal advisory committee meeting of the Defense Language Institute Foreign Language Center Board of Visitors, a subcommittee of the Army Education Advisory Committee. This meeting is open to the public.
The Defense Language Institute Foreign Language Center (DLIFLC) Board of Visitors Subcommittee will meet from 8:00 a.m. to 5:00 p.m. on December 12 and 13, 2018.
Defense Language Institute Foreign Language Center, Building 326, Weckerling Center, Presidio of Monterey, CA 93944.
Mr. Detlev Kesten, the Alternate Designated Federal Officer for the subcommittee, in writing at Defense Language Institute Foreign Language Center, ATFL-APAS-AA, Bldg. 614, Presidio of Monterey, CA 93944, by email at
The subcommittee meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of
Pursuant to 41 CFR 102-3.140d, the Committee is not obligated to allow a member of the public to speak or otherwise address the Committee during the meeting. Members of the public will be permitted to make verbal comments during the Committee meeting only at the time and in the manner described below. If a member of the public is interested in making a verbal comment at the open meeting, that individual must submit a request, with a brief statement of the subject matter to be addressed by the comment, at least seven business days in advance to the subcommittee's Alternate Designated Federal Official, via electronic mail, the preferred mode of submission, at the address listed in the
Department of the Army, DoD.
Announcement of competition.
Under the provisions of applicable laws and regulations, the Assistant Secretary of the Army for Acquisition, Logistics and Technology (ASA(ALT)) is announcing the second cohort of the Army Expeditionary Technology Search—xTechSearch II Prize Competition—for the Army to enhance engagements with the entrepreneurial funded community, small businesses, and other non-traditional defense partners. The xTechSearch program will provide an opportunity for businesses to pitch novel technology solutions, either a new application for an existing technology or an entirely new technology concept, to the Army.
1. December 31, 2018 at 12:59PM PST. Deadline for submission of White Papers to the xTechSearch competition. Submissions received after the deadline will not be considered.
2. February 25-March 8, 2019. Semifinalists—Up to 60 participants conduct technology pitches to xTechSearch panels.
3. March 26-28, 2019. Up to 25 finalists featured at the Association of the United States Army Global Force Symposium and Exposition in Huntsville, AL.
4. October 2019. Capstone Demonstration with Army subject matter experts and Leadership.
Proposals must be submitted at Challenge.gov:
Ms. Jennifer Smith, Deputy Director for Laboratory Management (ASA(ALT)) Office of the Deputy Assistant Secretary of the Army, Research and Technology, (703) 697-0685 or via Email at:
There may be only one submission per business. In addition, each entity:
• Shall be incorporated in and maintain a primary place of business in the United States;
• May not be a Federal entity or Federal employee acting within the scope of their employment.
• Sole proprietors may participate in xTechSearch if the individual is a citizen or permanent resident of the United States and the business is registered in the United States.
• Foreign companies may participate in xTechSearch by establishing a US domestic business relationship (
• Companies that have previously participated in the xTechSearch competition are eligible to participate for new technology concepts or improvements to prior submitted proposals.
Registered participants shall be required to agree to assume any and all risks and waive claims against the Federal Government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from their participation in a prize competition, whether the injury, death, damage, or loss arises through negligence or otherwise.
Participants shall be required to obtain liability insurance or demonstrate financial responsibility, in amounts determined by the Army, for claims by—
• Third parties for death, bodily injury, or property damage, or loss resulting from an activity carried out in connection with participation in a prize competition, with the Federal Government named as an additional insured under the registered participant's insurance policy and registered participants agreeing to indemnify the Federal Government against third party claims for damages arising from or related to prize competition activities; and
The Federal Government for damage or loss to Government property resulting from such an activity.
Prizes will be offered under 15 U.S.C. Section 3719 (Prize competitions).
• The total prize pool is $2.18M.
The Phase I proposal must be a white paper describing the novel technology concept, innovative application concept and integration with one or more of the Army's technology focus areas. The proposal must be submitted via the Challenge.gov portal as a single searchable PDF file containing:
• Title.
• Author(s).
•
○ Long Range Precision Fires.
○ Next Generation Combat Vehicle.
○ Future Vertical Lift.
○ Network with hardware, software, and infrastructure.
○ Air and Missile Defense.
○ Soldier Lethality.
○ Medical Technologies.
○ Military Engineering Technologies.
•
•
•
•
•
Contestants' concept papers will be reviewed by a panel of subject matter experts who will select the contestants to be invited to the xTechSearch Technology Pitch Forums. Companies selected by the panel will receive a prize of $4,000 and an invitation to Phase II: xTechSearch Technology Pitches.
Concept White Papers will be ranked using the following Scoring Criteria:
• Potential for Impact/Revolutionizing the Army—50%.
• Scientific and Engineering Viability—50%.
• Up to sixty (60) selected contestant semi-finalists will be invited to complete an in-person venture style pitch to a panel of Army subject matter experts and judges at locations across the United States.
• Companies will pitch their technology and a proposed live proof-of-concept demonstration for Phase III (15 minute pitch followed by 10 minutes for questions and answers).
• Up to twenty five (25) semifinalists selected by the judge panel will receive a prize of $10,000 and be invited to display an exhibit and make a formal public oral presentation of their proposal at the 2019 AUSA Global Force Symposium and Exposition Innovators' Corner in Huntsville, AL.
• Scoring Criteria:
○ Potential for Impact/Revolutionizing the Army—40%.
○ Scientific and Engineering Viability—40%.
○ Proof-of-Concept Demonstration Plan—10%.
○ Team Ability—10%.
• The AUSA Innovators' Corner phase provides up to twenty five (25) xTechSearch semifinalists to be featured at the AUSA Innovators' Corner at the AUSA Global Force meeting, 26-28 March 2019 in Huntsville, AL. The finalists will leverage Army-sponsored exhibit space to engage with Department of Defense (DoD) customers, Army leadership, industry partners, and academia.
• Up to twelve (12) Phase III prize winner finalists will be announced at AUSA and provided a prize of $120,000 and 6 months to demonstrate proof-of-concept for their xTechSearch technology at the Phase IV: xTechSearch Capstone Demonstration.
• Each Phase III finalist will demonstrate proof-of-concept for their technology solution to Army subject matter experts and DoD leadership at the AUSA Annual Meeting and Exposition, October 2019, Washington DC. A single grand-prize winner will be selected for the technology concept with the greatest potential for impact and to revolutionize the Army.
• The winner of the Finale Demonstration will be awarded a prize of $250,000.
15 U.S.C. Section 3719; Pub. L. 96-480, Section 24, as added Pub. L. 111-358, title I, Section 105a, Jan. 4, 2011 Stat. 3989.
Office of the Under Secretary of Defense for Personnel and Readiness, DoD.
30-Day information collection notice.
The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by December 24, 2018.
Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at
Fred Licari, 571-372-0493, or
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
•
Requests for copies of the information collection proposal should be sent to Mr. Licari at
Office of the Assistant Secretary of Defense for Health Affairs, DoD.
30-Day information collection notice.
The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by December 24, 2018.
Comments and recommendations on the proposed information collection should be emailed to Ms. Cortney Higgins, DoD Desk Officer, at
Fred Licari, 571-372-0493, or
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
•
Requests for copies of the information collection proposal should be sent to Mr. Licari at
Office of the Under Secretary of Defense for Personnel and Readiness (OUSD (P&R)), Federal Voting Assistance Program (FVAP), DoD.
Information collection notice.
In compliance with the
Consideration will be given to all comments received by January 22, 2019.
You may submit comments, identified by docket number and title, by any of the following methods:
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Federal Voting Assistance Program, ATTN: Sarah Gooch, 4800 Mark Center Drive, Mailbox 10, Alexandria, Virginia 22350-5000 or call 703-588-1584.
The collected information will be used by election officials to process uniformed service members, spouses and overseas citizens who submit their information to register to vote, receive an absentee ballot or cast a write-in ballot. The collected information will be retained by election officials to provide election materials, including absentee ballots, to the uniformed services, their eligible family members and overseas voters during the form's eligibility period provided by State law. No information from the Federal Post Card Application (FPCA) is collected or retained by the Federal government.
The applicant is required to update and resubmit the information annually, whenever they change their mailing address or as otherwise required by State law. If the information is not submitted annually or whenever they change their mailing address, the applicant may not receive ballots for elections for Federal office in that calendar year.
Office of the Under Secretary of Defense for Personnel and Readiness, DoD.
30-Day information collection notice.
The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by December 24, 2018.
Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at
Fred Licari, 571-372-0493, or
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
•
Requests for copies of the information collection proposal should be sent to Mr. Licari at
Office of the Under Secretary of Defense for Acquisition and Sustainment, DoD.
30-day information collection notice.
The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by December 24, 2018.
Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at
Fred Licari, 571-372-0493, or
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
•
Instructions: All submissions received must include the agency name, Docket ID number, and title for this
Requests for copies of the information collection proposal should be sent to Mr. Licari at
Office of the Under Secretary of Defense for Personnel and Readiness, DoD.
30-Day information collection notice.
The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by December 24, 2018.
Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at
Fred Licari, 571-372-0493, or
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
•
Requests for copies of the information collection proposal should be sent to Mr. Licari at
Under Secretary of Defense for Acquisition and Sustainment, DoD.
Information collection notice.
In compliance with the
Consideration will be given to all comments received by January 22, 2019.
You may submit comments, identified by docket number and title, by any of the following methods:
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to Defense Logistics Agency Headquarters (DLA), ATTN: Ms. Nina Beshai, J62BK Information Operations, 8725 John Kingman Road, Fort Belvoir, VA 22060-6221, or call (571) 767-9810.
Office of the Assistant Secretary of the Navy, DoD.
30-Day information collection notice.
The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by December 24, 2018.
Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at
Fred Licari, 571-372-0493, or
Reasonable Accommodations (RA) Tracker; SECNAV Form 12306/1T Confirmation of Reasonable Accommodation Request; OMB Control Number 0703-0063.
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
•
Requests for copies of the information collection proposal should be sent to Mr. Licari at
Office of Postsecondary Education (OPE), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.
Interested persons are invited to submit comments on or before December 24, 2018.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Sara Starke, 202-453-7681.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Department of Energy.
Notice of meetings.
The Industry Advisory Board (IAB) to the International Energy Agency (IEA) will meet on November 27-29, 2018.
November 27-29, 2018.
French Ministry for the Ecological and Inclusive Transition, Tour Séquoia, Place Carpeaux, La Défense, Paris, France; UIC-P Conference Centre, 16 rue Jean Rey, 75015, Paris, France.
Thomas Reilly, Assistant General Counsel for International and National Security Programs, Department of Energy, 1000 Independence Avenue SW, Washington, DC 20585, (202) 586-5000.
In accordance with section 252(c)(1)(A)(i) of the Energy Policy and Conservation Act (42 U.S.C. 6272(c)(1)(A)(i)) (EPCA), the following notice of meetings is provided:
A meeting involving members of the Industry Advisory Board (IAB) to the International Energy Agency (IEA) in connection with a workshop meeting of the IEA's Standing Group on Emergency Questions (SEQ) will be held at the French Ministry for the Ecological and Inclusive Transition, Tour Séquoia, Place Carpeaux, La Défense, Paris, France, on November 27, 2018. The purpose of the workshop meeting, which is a follow up from the workshop meeting held on September 18-19, 2018, is to discuss relevant key issues in order to establish a basis for drafting a proposal for possible improvements to the emergency oil stockholding requirement.
The agenda of the meeting is under the control of the IEA. It is expected that the IEA will adopt the following agenda:
As provided in section 252(c)(1)(A)(ii) of the Energy Policy and Conservation Act (42 U.S.C. 6272(c)(1)(A)(ii)), Representatives of the Directorate-General for Competition of the European Commission and representatives of members of the IEA Group of Reporting Companies may attend the meeting as observers. The meeting will also be open to representatives of the Secretary of Energy, the Secretary of State, the Attorney General, and the Federal Trade Commission severally, to any United States Government employee designated by the Secretary of Energy, and to the representatives of Committees of the Congress.
A meeting of the Industry Advisory Board (IAB) to the International Energy Agency (IEA) will be held at the French Ministry for the Ecological and Inclusive Transition, Tour Séquoia, Place Carpeaux, La Défense, Paris, France, commencing at 9:30 a.m. on November 28, 2018. The purpose of this notice is to permit attendance by representatives of U.S. company members of the IAB at a meeting of the IEA's Standing Group on Emergency Questions (SEQ), which is scheduled to be held at the same location and time. The IAB will also hold a preparatory meeting among company representatives at the same location at 8:30 a.m. on November 28. The agenda for this preparatory meeting is to review the agenda for the SEQ meeting.
The agenda of the SEQ meeting is under the control of the SEQ. It is expected that the SEQ will adopt the following agenda:
Representatives of the Directorate-General for Competition of the European Commission and representatives of members of the IEA Group of Reporting Companies may attend the meeting as observers. The meeting will also be open to representatives of the Secretary of Energy, the Secretary of State, the Attorney General, and the Federal Trade Commission severally, to any United States Government employee designated by the Secretary of Energy, and to the representatives of Committees of the Congress.
A meeting of the Industry Advisory Board (IAB) to the International Energy Agency (IEA) will be held in the UIC-P Conference Centre, 16 rue Jean Rey, 75015, Paris, France, on November 29, 2018, commencing at 09:30 a.m. The purpose of this notice is to permit attendance by representatives of U.S. company members of the IAB at a joint meeting of the IEA's Standing Group on Emergency Questions (SEQ) and the IEA's Standing Group on the Oil Market (SOM), which is scheduled to be held at the same location and time.
The agenda of the meeting is under the control of the SEQ and the SOM. It is expected that the SEQ and the SOM will adopt the following agenda:
Representatives of the Directorate-General for Competition of the European Commission and representatives of members of the IEA Group of Reporting Companies may attend the meeting as observers. The meeting will also be open to representatives of the Secretary of Energy, the Secretary of State, the Attorney General, and the Federal Trade Commission severally, to any United States Government employee designated by the Secretary of Energy, and to the representatives of Committees of the Congress.
Take notice that on November 15, 2018, pursuant to sections 13(1), 15(1) and 15(7) of the Interstate Commerce Act (ICA),
The Complainant states that a copy of the complaint was served on the contacts for the Respondent listed on the Commission's list of Corporate Officials.
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. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainant.
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 following hydroelectric application has been filed with the Commission and is available for public inspection.
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
k. Pursuant to section 4.32(b)(7) of the Commission's regulations, if any resource agency, Indian Tribe, or person believes that an additional scientific study should be conducted in order to form an adequate factual basis for a complete analysis of the application on its merit, the resource agency, Indian Tribe, or person must file a request for a study with the Commission not later than 60 days from the date of filing of the application, and serve a copy of the request on the applicant.
l. Deadline for filing additional study requests and requests for cooperating agency status: December 31, 2018.
The Commission strongly encourages electronic filing. Please file additional study requests and requests for cooperating agency status using the Commission's eFiling system at
m. The application is not ready for environmental analysis at this time.
n. The City electronically filed the application with the Commission after the close of business on October 31, 2018. Pursuant to 18 CFR 385.2001(a)(2), any document received after regular business hours is considered filed on the next regular business day. By this notice, the requirement under 18 CFR 16.20(c) to file the subsequent license application at least 24 months before the expiration of the existing license (
o. The Woonsocket Falls Project utilizes water from the impoundment created by the Corps' Woonsocket Falls Dam, and consists of: (1) A 14-foot-wide, 20.5-foot-high concrete intake structure located about 60 feet upstream of the Woonsocket Falls Dam and fitted with a 12-foot-wide, 18-foot-high steel trash rack having 3.5-inch clear bar spacing; (2) a 275-foot long, 12-foot-wide, 10-foot-high concrete penstock; (3) a 65-foot-long, 25-foot-wide, 20-foot-high concrete powerhouse containing one adjustable blade turbine-generator unit with an authorized capacity of 1,200 kilowatts; (4) a 50-foot-long, 12.5-foot-diameter steel draft tube; (5) an approximately 50-foot-long, 20-foot-wide, 15-foot-deep tailrace; (6) a 35-foot-long 4.16 kilovolt (kV) generator lead line, a 4.16/13.8-kV step-up transformer, a 1,200-foot-long, and a 13.8-kV transmission line connecting the project generator to the regional grid; and (7) appurtenant facilities.
The project bypasses approximately 360 feet of the Blackstone River and there is currently no required minimum instream flow for the bypassed reach. However, the City operates the project in a run-of-river (ROR) mode and voluntarily maintains a minimum flow of 20 cubic feet per second (cfs) over the crest of the dam to the bypassed reach using an automatic pond level controller. The Woonsocket Falls project has an average annual generation of approximately 4,580 megawatt-hours.
The City proposes to: (1) Continue operating the project in a ROR mode; (2) provide a year-round minimum flow of 20 cfs into the bypassed reach; (3) provide upstream eel passage at the project; and (4) implement targeted nighttime turbine shutdowns to facilitate downstream eel passage.
p. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website at
You may also register online at
q. Procedural schedule and final amendments: The application will be processed according to the following preliminary schedule. Revisions to the schedule will be made as appropriate.
Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis.
In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission) regulations, 18 CFR part 380, the Office of Energy Projects has reviewed the application for a subsequent license for the Municipal Hydroelectric Project, located on the Little River, near the City of Radford, in Montgomery and Pulaski Counties, Virginia, and has prepared an Environmental Assessment (EA) for the project.
The EA contains staff's analysis of the potential environmental impacts of the project and concludes that licensing the project, with appropriate environmental protective measures, would not constitute a major federal action that would significantly affect the quality of the human environment.
A copy of the EA is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website at
You may also register online at
Any comments should be filed within 30 days from the date of this notice.
The Commission strongly encourages electronic filing. Please file comments using the Commission's eFiling system at
For further information, contact Allyson Conner at (202) 502-6082 or by email at
The staff of the Federal Energy Regulatory Commission (FERC or Commission) has prepared a draft environmental impact statement (EIS) for the Gulf LNG Liquefaction Project, proposed by Gulf LNG Liquefaction Company, LLC; Gulf LNG Energy, LLC; and Gulf LNG Pipeline, LLC (GLP) (collectively referred to as Gulf LNG) in the above-referenced docket. Gulf LNG requests authorization pursuant to sections 3(a) and 7 of the
The draft EIS assesses the potential environmental effects of construction and operation of the Gulf LNG Liquefaction Project in accordance with the requirements of the National Environmental Policy Act (NEPA). The FERC staff concludes that approval of the proposed Project, with the mitigation measures recommended in the EIS, would have some adverse environmental impacts; however, these impacts would be avoided or reduced to less-than-significant levels.
U.S. Army Corps of Engineers; U.S. Coast Guard; U.S. Department of Energy, Office of Fossil Energy; the U.S. Department of Transportation's Pipeline and Hazardous Materials Safety Administration; U.S. Fish and Wildlife Service; National Oceanic and Atmospheric Administration, National Marine Fisheries Service; and U.S. Environmental Protection Agency participated as cooperating agencies in the preparation of the EIS. In addition, the Mississippi Office of the Secretary of State has jurisdiction over the wetland mitigation property and, therefore, is assisting us as a cooperating agency. Cooperating agencies have jurisdiction by law or special expertise with respect to resources potentially affected by the proposal and participate in the NEPA analysis. Although the cooperating agencies provided input to the conclusions and recommendations presented in the draft EIS, the agencies will present their own conclusions and recommendations in their respective Records of Decision for the Project.
The draft EIS addresses the potential environmental effects of the construction and operation of the following proposed facilities:
• Feed gas pre-treatment facilities, including a mercury removal system, an acid gas removal system (to remove carbon dioxide and hydrogen sulfide), a molecular sieve dehydration system (to remove water), and a heavy hydrocarbon removal system (to remove natural gas liquids);
• two separate propane precooled mixed refrigerant liquefaction trains that liquefy natural gas, each with a nominal liquefaction capacity of 5 million metric tons per year (mtpy) and a maximum capacity of more than 5.4 mtpy of LNG;
• liquefaction facility utilities and associated systems, including two gas-fired turbine compressors per liquefaction train;
• storage facilities for condensate, ammonia and refrigerants;
• utilities systems, including instrument, plant air, and nitrogen;
• a truck loading/unloading facility to unload refrigerants and to load condensate produced during the gas liquefaction process;
• four flares (including one spare flare) in a single flare tower to incinerate excess gases associated with maintenance, startup/shutdown, and upset conditions during an emergency;
• two supply docks (North and South Supply Docks) designed to receive barges transporting materials and large equipment during construction, with one dock retained for use during operation;
• new in-tank LNG loading pumps in the existing LNG storage tanks to transfer LNG through the existing transfer lines to LNG marine carriers;
• new spill impoundment systems designed to contain LNG, refrigerants and other hazardous fluids;
• minor changes to piping at the existing berthing facility to permit bi-directional flow;
• a new concrete storm surge protection wall that connects to the existing storm surge protection wall near the southwest corner of the Terminal Expansion site and extends along the southern border of the Terminal Expansion site;
• a new earthen berm extending from the northeastern to the southeastern boundaries of the Terminal Expansion site, between the Terminal Expansion and the Bayou Casotte Dredged Material Management Site, and connecting to the new segments of the storm surge protection wall;
• six off-site construction support areas for use as staging and laydown areas, contractor yards, and parking;
• modifications to the existing metering stations at the existing Gulfstream Pipeline Company and Destin Pipeline Company interconnection facilities;
• modifications to the existing Gulf LNG Pipeline at the existing Terminal to provide a connection to the inlet of the LNG liquefaction pre-treatment facilities.
The Commission mailed a copy of the
Any person wishing to comment on the draft EIS may do so. Your comments should focus on draft EIS's disclosure and discussion of potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. To ensure consideration of your comments on the proposal in the final EIS, it is important that the Commission receive your comments on or before 5:00 p.m. Eastern Time on January 7, 2019.
For your convenience, there are four methods you can use to submit your comments to the Commission. The Commission will provide equal consideration to all comments received, whether filed in written form or provided verbally. The Commission encourages electronic filing of comments and has staff available to assist you at (866) 208-3676 or
(1) You can file your comments electronically using the eComment feature on the Commission's website (
(2) You can file your comments electronically by using the eFiling feature on the Commission's website (
(3) You can file a paper copy of your comments by mailing them to the following address. Be sure to reference the project docket number (CP15-521-000) with your submission: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
(4) In lieu of sending written or electronic comments, the Commission invites you to attend a public comment session its staff will conduct in the Project area to receive comments on the draft EIS, scheduled as follows:
The primary goal of this comment session is to have you identify the specific environmental issues and concerns with the draft EIS. Individual verbal comments will be taken on a one-on-one basis with a court reporter. This format is designed to receive the maximum amount of verbal comments, in a convenient way during the timeframe allotted.
The comment session is scheduled from 4:00 p.m. to 8:00 p.m. local time. You may arrive at any time after 4:00 p.m. There will not be a formal presentation by Commission staff when the session opens. If you wish to speak, the Commission staff will hand out numbers in the order of your arrival. Comments will be taken until 8:00 p.m. However, if no additional numbers have been handed out and all individuals who wish to provide comments have had an opportunity to do so, staff may conclude the session at 7:30 p.m. Please see appendix 1 for additional information on the session format and conduct.
Your verbal comments will be recorded by the court reporter (with FERC staff or representative present) and become part of the public record for this proceeding. Transcripts will be publicly available on FERC's eLibrary system (see below for instructions on using eLibrary). If a significant number of people are interested in providing verbal comments in the one-on-one settings, a time limit of 5 minutes may be implemented for each commentor.
It is important to note that verbal comments hold the same weight as written or electronically submitted comments. Although there will not be a formal presentation, Commission staff will be available throughout the comment session to answer your questions about the environmental review process.
Any person seeking to become a party to the proceeding must file a motion to intervene pursuant to Rule 214 of the Commission's Rules of Practice and Procedures (18 CFR part 385.214). Motions to intervene are more fully described at
Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website (
In addition, the Commission offers a free service called eSubscription that allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) is planning to submit the information collection request (ICR), General Hazardous Waste Facility (EPA ICR No. 1571.12, OMB Control No. 2050-0120) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA). Before doing so, the EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through April 30, 2019. 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.
Comments must be submitted on or before January 22, 2019.
Submit your comments, referencing by Docket ID No. EPA-HQ-OLEM-2018-0690, online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Peggy Vyas, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 703-308-5477; fax number: 703-308-8433; email address:
Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at
Pursuant to section 3506(c)(2)(A) of the PRA, the EPA is soliciting comments and information to enable it to: (i) 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; (ii) 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; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) 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,
• Maintaining records of all hazardous wastes identified or listed under subtitle C that are treated, stored, or disposed of, and the manner in which such wastes were treated, stored, or disposed of;
• Operating methods, techniques, and practices for treatment, storage, or disposal of hazardous waste;
• Location, design, and construction of such hazardous waste treatment, disposal, or storage facilities;
• Contingency plans for effective action to minimize unanticipated damage from any treatment, storage, or disposal of any such hazardous waste; and
• Maintaining or operating such facilities and requiring such additional qualifications as to ownership, continuity of operation, training for personnel, and financial responsibility as may be necessary or desirable.
The regulations implementing these requirements are codified in 40 CFR parts 264 and 265. The collection of this information enables the EPA to properly determine whether owners/operators or hazardous waste treatment, storage, and disposal facilities meet the requirements of Section 3004(a) of RCRA.
Section 309(a) of the Clean Air Act requires that EPA make public its
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) is planning to submit the information collection request (ICR), Generator Standards Applicable to Laboratories Owned by Eligible Academic Entities (EPA ICR No. 2317.04, OMB Control No. 2050-0204) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Comments must be submitted on or before January 22, 2019.
Submit your comments, referencing by Docket ID No. EPA-HQ-OLEM-2018-0692, online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Kristen Fitzgerald, (mail code 5304P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 703-308-8286; fax number: 703-308-0514; email address:
Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at
Pursuant to section 3506(c)(2)(A) of the PRA, the EPA is soliciting comments and information to enable it to: (i) 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; (ii) 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; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) 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,
Activities, General Information 202-564-7156 or
Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at:
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency is planning to submit an information collection request (ICR), Distribution of Offsite Consequence Analysis Information under Section 112(r)(7)(H) of the Clean Air Act (CAA), as amended—EPA No. 1981.07, OMB Control Number 2050-0172 to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
Comments must be submitted on or before January 22, 2019.
Submit your comments, referencing Docket ID No. EPA-HQ-OAR-2003-0073 referencing the Docket ID numbers provided for each item in the text, online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Wendy Hoffman, Office of Emergency Management, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-8794; email address:
Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at
Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) 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; (ii) 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; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) 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,
On August 5, 1999, the President signed the Chemical Safety Information, Site Security, and Fuels Regulatory Relief Act (CSISSFRRA). The Act required the President to promulgate regulations on the distribution of OCA information (CAA section 112(r)(7)(H)(ii)). The President delegated to EPA and the Department of Justice (DOJ) the responsibility to promulgate regulations to govern the dissemination of OCA information to the public. The final rule was published on August 4, 2000 (65 FR 48108). The regulations imposed minimal information and recordkeeping requirements.
In accordance with the final rule, the federal government established 55 reading rooms at federal facilities geographically distributed across the United States and its territories. At these reading rooms, members of the public are able to read, but not mechanically copy or remove paper copies of OCA information for up to 10 stationary sources per calendar month. At these reading rooms, the members of the
The final rule also authorizes and encourages state and local government officials to have access to OCA information for their official use, and to provide members of the public with read-only access to OCA sections of RMPs for sources located within the jurisdiction of the LEPC where the person lives or works and for any other stationary sources with vulnerability zones extending into the LEPC's jurisdiction.
EPA also established a Vulnerable Zone Indicator System (VZIS) that informs any person located in any state whether an address specified by that person might be within the vulnerable zone of one or more stationary sources, according to the data reported in RMPs. The VZIS is available on the internet. Members of the public who do not have access to the internet are able to obtain the same information by regular mail request to the EPA.
The Agency is requesting comments on the burden and costs estimated in the current ICR. EPA will revise the burden and costs, if necessary, prior to submitting the package to OMB for approval for this information collection.
Pursuant to the provisions of the “Government in the Sunshine Act” (5 U.S.C. 552b), notice is hereby given that at 10:29 a.m. on Tuesday, November 20, 2018, the Board of Directors of the Federal Deposit Insurance Corporation met in closed session to consider matters related to the Corporation's supervision, corporate, and resolution activities.
In calling the meeting, the Board determined, on motion of Director Martin J. Gruenberg, seconded by Director Mick Mulvaney (Acting Director, Consumer Financial Protection Bureau), and concurred in by Director Joseph M. Otting (Comptroller of the Currency), and Chairman Jelena McWilliams, that Corporation business required its consideration of the matters which were to be the subject of this meeting on less than seven days' notice to the public; that no earlier notice of the meeting was practicable; that the public interest did not require consideration of the matters in a meeting open to public observation; and that the matters could be considered in a closed meeting by authority of subsections (c)(2), (c)(4), (c)(6), (c)(8), (c)(9)(A)(ii), and (c)(9)(B) of the “Government in the Sunshine Act” (5 U.S.C. 552b(c)(2), (c)(4), (c)(6), (c)(8), (c)(9)(A)(ii), and (c)(9)(B).
Federal Deposit Insurance Corporation (FDIC).
Notice and request for comment.
The FDIC, as part of its obligations under the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to take this opportunity to comment on the renewal of the existing information collection described below (3064-0072). On August 16, 2018, the FDIC requested comment for 60 days on a proposal to renew the information collection described below. No comments were received. The FDIC hereby gives notice of its plan to submit to OMB a request to approve the renewal of this collection, and again invites comment on this renewal.
Comments must be submitted on or before December 24, 2018.
Interested parties are invited to submit written comments to the FDIC by any of the following methods:
•
•
•
•
Jennifer Jones, Counsel, 202-898-6768,
On August 16, 2018, the FDIC requested comment for 60 days on a proposal to renew the information collection described below. No comments were received. The FDIC hereby gives notice of its plan to submit to OMB a request to approve the renewal of this collection, and again invites comment on this renewal.
1.
This is a collection of information involving submission of information and various forms by contractors who desire to do business with the FDIC in connection with contract proposals submitted in response to FDIC solicitations.
In order to obtain competitive proposals and contracts from vendors interested in providing goods or services to the FDIC, the FDIC uses the Solicitation/Award request (Form 3700/55). This form is used in connection with a request for proposal and a request for price quotations.
In anticipation of a particular contract solicitation, the FDIC may first conduct market research to narrow down the list of potential contractors. This is done through a request for information (RFI). Following the RFI process, potential firms may be notified if they are to be included in the next phase of the acquisition process.
The FDIC Background Investigation Questionnaire for Contractor Personnel and Subcontractors (Form 1600/04), Background Investigation Questionnaire for Contractors (Form1600/07), Integrity and Fitness Representations and Certifications (Form 3700/12), and Leasing Representations and Certifications (Form 3700/44) are a result of the implementation of 12 CFR part 366. The FDIC adopted 12 CFR part 366 pursuant to Section 12(f)(3) and (4) of the Federal Deposit Insurance Act, 12 U.S.C. 1822(f)(3) and (4), and the rulemaking authority of the FDIC found at 12 U.S.C. 1819. Pursuant to those sections and consistent with the goals and purposes of titles 18 and 41 of the U.S. Code, the rule establishes the minimum standards of integrity and fitness that contractors, subcontractors, and employees of contractors and subcontractors must meet if they perform any service or function on behalf of the FDIC. This rule includes regulations governing conflicts of interest, ethical responsibility, and use of confidential information in accordance with 1822(f)(3); and the prohibitions and the submission of information in accordance with 1822(f)(4). This rule applies to a person who submits an offer to perform or performs, directly or indirectly, a contractual service or function on behalf of the FDIC.
In addition, the evaluation of an offeror's past performance under formal contracting procedures is a mandatory technical evaluation criterion in the FDIC's standard solicitation document. In support of the evaluation of the past performance criterion, the FDIC Past Performance Questionnaire (Form 3700/57) was developed to be submitted by other government agencies or commercial businesses who are doing business, or have done business, with the contractor that the FDIC is evaluating.
The FDIC Contractor Representations and Certifications form (Form 3700/4A) must be completed by any offeror that responds to a solicitation for an award over $100,000.
Finally, in connection with a contract proposal, the FDIC seeks a commitment from an FDIC contractor to ensure, to the maximum extent possible consistent with applicable law, the fair inclusion of minorities and women in its workforce and the workforces of its applicable subcontractors. The commitment is asserted by the FDIC Fair Inclusion of Minorities and Women form (Form 3700/59), which is a contract clause implementing Section 342(c)(2) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (12 U.S.C. 5452). The clause asserts the FDIC's right to request documentation from the contractor that demonstrates the contractor's good faith effort to include minorities and women in its workforce and subcontractors' workforces.
The annual burden for this information collection is estimated to be 7,830 hours. This represents an increase of 5,496 hours from the current burden estimate of 2,334 hours. This increase is not due to any new requirements imposed by the FDIC. Rather, it is due to FDIC's reassessment of the burden hours associated with the contracting
Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the information collection, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. All comments will become a matter of public record.
Federal Deposit Insurance Corporation (FDIC).
Notice and request for comment.
The FDIC, as part of its obligations under the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to take this opportunity to comment on the renewal of the existing information collection described below.
Comments must be submitted on or before January 22, 2019.
Interested parties are invited to submit written comments to the FDIC by any of the following methods:
•
•
•
•
All comments should refer to the relevant OMB control number. A copy of the comments may also be submitted to the OMB desk officer for the FDIC: Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503.
Manny Cabeza, Counsel, 202-898-3767,
Proposal to renew the following currently approved collection of information:
1.
The Government Securities Act of 1986 requires all financial institutions acting as government securities brokers and dealers to notify their Federal regulatory agencies of their broker-dealer activities, unless exempted from the notice requirements by Treasury Department regulation.
The Form G-FIN and Form G-FINW are used by insured State nonmember banks that are government securities brokers or dealers to notify the FDIC of their status or that they have ceased to function as a government securities broker or dealer.
The Form G-FIN-4 is used by associated persons of insured State nonmember banks that are government securities brokers or dealers to provide certain information to the bank and to the FDIC concerning employment, residence, and statutory disqualification.
The Form G-FIN-5 is used by insured State nonmember banks that are government securities brokers or dealers to notify the FDIC that an associated person is no longer associated with the
There is no change in the method or substance of the collection. The overall reduction in burden hours (from 17 hours to 13.25 hours) is the result of economic fluctuation. In particular, the number of respondents has decreased from 17 to 8 while the hours per response and frequency of responses have remained the same.
Pursuant to the provisions of the “Government in the Sunshine Act” (5 U.S.C. 552b), notice is hereby given that the Federal Deposit Insurance Corporation's Board of Directors met in open session at 10:00 a.m. on Tuesday, November 20, 2018, to consider the following matters:
Disposition of minutes of previous Board of Directors' Meetings.
Memorandum and resolution re: Regulatory Capital Rule: Capital Simplification for Qualifying Community Banking Organizations.
Memorandum and resolution re: Notice of Proposed Rulemaking to Increase the Appraisal Threshold for Residential Real Estate Transactions, Implement the Residential Rural Exemption, and Require Appropriate Appraisal Review.
Memorandum and resolution re: Final Rule on Transferred OTS Regulations Regarding Fiduciary Powers of State Savings Associations and Consent Requirements for the Exercise of Trust Powers.
Memorandum and resolution re: Final Rule to Revise the FDIC's Regulations Concerning Inflation-Adjusted Maximum Civil Money Penalty Amounts.
Report of actions taken pursuant to authority delegated by the Board of Directors.
Memorandum and resolution re: Notice of Proposed Rulemaking on Proposed Changes to Applicability Thresholds for Regulatory Capital Requirements and Liquidity Requirements.
In calling the meeting, the Board determined, on motion of Director Martin J. Gruenberg, seconded by Director Mick Mulvaney (Acting Director, Consumer Financial Protection Bureau), concurred in by Director Joseph Otting (Comptroller of the Currency), and Chairman Jelena McWilliams, that Corporation business required its consideration of the matters on less than seven days' notice to the public; and that no earlier notice of the meeting than that previously provided on November 14, 2018, was practicable.
The meeting was held in the Board Room located on the sixth floor of the FDIC Building located at 550 17th Street NW, Washington, DC.
Federal Deposit Insurance Corporation (FDIC).
Notice and request for comment.
The FDIC, as part of its obligations under the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to take this opportunity to comment on the renewal of the existing information collections described below.
Comments must be submitted on or before January 22, 2019.
Interested parties are invited to submit written comments to the FDIC by any of the following methods:
•
•
•
•
All comments should refer to the relevant OMB control number. A copy of the comments may also be submitted to the OMB desk officer for the FDIC: Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503.
Manny Cabeza, Counsel, 202-898-3767,
1.
State savings associations must file a notice of intent to convert to stock form, and provide the FDIC with copies of documents filed with state and federal banking and/or securities regulators in connection with any proposed mutual-to-stock conversion.
There is no change in the method or substance of the collection. The overall reduction in burden hours is the result of economic fluctuation. In particular, the number of respondents has decreased while the hours per response and frequency of responses have remained the same.
2.
The Interagency Guidance on Response Programs for Unauthorized Access to Customer Information and Customer Notice describes the federal banking agencies' expectations regarding a response program, including customer notification procedures, that a financial institution should develop and apply under the circumstances described in the
There is no change in the method or substance of the information collection. With respect to the third party disclosure requirements associated with providing notices regarding unauthorized access to customer information, the FDIC revised its estimate of the response time from 29 hours per response to 36 hours per response. The agency also revised its estimate of the number of annual respondents from 80 to 315 to reflect current industry trend data.
3.
The regulation containing this information collection requirement is 12 CFR part 334, which implements sections 114 and 315 of the Fair and Accurate Credit Transactions Act of 2003 (FACT Act), Public Law 108-159 (2003).
There is no change in the method or substance of the information collection. The total estimated annual burden hours have increased because of the inclusion of the agency's estimate of third-party disclosure burden associated with the notices required by Section 315 of the FACT Act which were previously not included because the agencies had taken the position that the entities covered by the regulation were already furnishing addresses that they had reasonably confirmed to be accurate to consumer reporting agencies from which they receive a notice of address discrepancy as a usual and customary business practice. The above burden estimate now includes burden for the third-party disclosure requirements associated with Section 315 which resulted in an increase in estimated annual burden of 14, 300 hours. This increase was offset, in part, by a reduction in the estimated number of respondents from 4, 017 to 3,575 which resulted in a decrease in the estimated annual burden for the recordkeeping requirement associated with Sections 114 and 315 from 64, 272 hour to 57,200 hours. The net effect of the revision is an increase in estimated annual burden from 64,272 hours to 71,500 hours.
Material covered by 5 U.S.C. (c)(4), (c)(6), and (c)(9)(B).
Kimberly Weaver, Director, Office of External Affairs, (202) 942-1640.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of vouchers as well as the approval of products redeeming a voucher. FDA has determined that AJOVY (fremanezumab-vfrm), approved September 14, 2018, meets the redemption criteria.
Althea Cuff, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4061, Fax: 301-796-9858, email:
Under section 529 of the FD&C Act (21 U.S.C. 360ff), which was added by FDASIA, FDA will report the issuance of rare pediatric disease priority review vouchers and the approval of products for which a voucher was redeemed. FDA has determined that AJOVY (fremanezumab-vfrm), approved September 14, 2018, meets the redemption criteria.
For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&C Act, go to
Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.
Notice.
The Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council) requests information from the general public and stakeholders related to efforts and strategies to combat Antibiotic Resistance (AR). Given the evolution of AR and the long-term nature of the problem, the Secretary of Health and Human Services (HHS) tasked the Advisory Council with identifying significant areas that have emerged since the release of the National Action Plan (NAP) for Combatting Antibiotic-Resistant Bacteria (CARB) in 2015. To aid in the process of developing its response to the Secretary's task, the Advisory Council has posted this Request for Information (RFI) to hear from a wide range of stakeholders and sectors relevant to the overall CARB effort. This RFI offers the opportunity for the public, including interested individuals, organizations, associations, industries, and others, to provide their input on new priority
Responses to the RFI must be received by 11:59 p.m. on January 7, 2019 to be considered. The questions in the RFI are available through an online form on the Advisory Council's web page at
Comments must be received by 11:59 p.m. on January 7, 2019 to be considered.
Individuals are encouraged to submit their responses through one of the following methods. Utilization of the online form available on
•
•
• All submissions will receive an electronic confirmation acknowledging receipt of your response, but you will not receive individualized feedback on any suggestions.
Dr. Jomana Musmar, Acting Designated Federal Officer, Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services, Room 715H, Hubert H. Humphrey Building, 200 Independence Avenue SW, Washington, DC 20201. Phone: (202) 690-5566; email:
Under Executive Order 13676, dated September 18, 2014, authority was given to the Secretary of Health and Human Services (HHS) to establish the Advisory Council, in consultation with the Secretaries of Defense and Agriculture. Activities of the Advisory Council are governed by the provisions of Public Law 92-463, as amended (5 U.S.C. App.), which sets forth standards for the formation and use of federal advisory committees.
The Advisory Council will provide advice, information, and recommendations to the Secretary of HHS regarding programs and policies intended to support and evaluate the implementation of Executive Order 13676, including the National Strategy for CARB and the Action Plan (NAP). The Advisory Council shall function solely for advisory purposes.
In carrying out its mission, the Advisory Council will provide advice, information, and recommendations to the Secretary regarding programs and policies intended to preserve the effectiveness of antibiotics by optimizing their use; advance research to develop improved methods for combating AR and conducting antibiotic stewardship; strengthen surveillance of antibiotic-resistant bacterial infections; prevent the transmission of antibiotic-resistant bacterial infections; advance the development of rapid point-of-care and agricultural diagnostics; further research on new treatments for bacterial infections; develop alternatives to antibiotics for agricultural purposes; maximize the dissemination of up-to-date information on the appropriate and proper use of antibiotics to the general public and human and animal healthcare providers; and improve international coordination of efforts to combat AR.
In response to the AR threat, the USG developed the National Strategy for Combating Antibiotic-Resistant Bacteria (CARB) in 2014. The Strategy takes a One Health approach to combating antibiotic resistance based on the persistence of AR within our global environment and the recognition that integrated multi-sectoral action is needed to prevent the emergence and spread of AR. In 2015, the U.S. government issued the corresponding National Action Plan (NAP) for CARB, providing a five-year roadmap (2015-2020) to guide the Nation in implementing the following five goals outlined in the Strategy:
1. Slow the emergence of resistant bacteria and prevent the spread of resistant infections;
2. Strengthen national One Health surveillance efforts to combat resistance;
3. Advance development and use of rapid and innovative diagnostic tests for identification and characterization of resistant bacteria;
4. Accelerate basic and applied research and development for new antibiotics and other therapeutics, including vaccines; and
5. Improve international collaboration and capacities for antibiotic resistance prevention, surveillance, control and antibiotic research and development.
The U.S. government has made meaningful progress towards these goals; however, since the issuance of the NAP in 2015, the domestic and international landscape has changed with continued unparalleled advancement and innovation in technology and the life sciences. Additional action is needed and opportunities exist to continue this progress beyond 2020. As such, the U.S. Government will issue a second iteration of the NAP that will guide action on AR for the period of 2020-2025. The development of this draft will involve the U.S. Government's careful consideration of progress to date on the current NAP, including barriers to progress in certain areas and new developments across sectors, at home and abroad.
• In the context of the existing five goals, on what new priorities should the
In preparing your response, please be sure to:
○ Consider how your response fits into the existing One Health paradigm, and how your proposed priority should be further pursued by the U.S. Government;
○ Provide an answer that is feasible and actionable by the U.S. Government;
○ Limit your responses to no more than two priorities for each of the five goals (a maximum of 10 can be submitted);
○ Summarize your response for each priority area in 250 words or less, including its scientific justification;
○ Indicate whether your response is relevant domestically, internationally, or both;
○ Indicate the domain(s) to which your response applies—human, animal, and/or environmental health;
○ Include citations to support your response (references must be in the form of an active link or citation; we will not accept attachments. Peer-reviewed citations and journal links are highly encouraged.
More information can be found at
Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.
Notice.
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council). The meeting will be open to the public; a public comment session will be held during the meeting. Pre-registration is required for members of the public who wish to attend the meeting and who wish to participate in the public comment session. Individuals who wish to attend the meeting and/or send in their public comment via email should send an email to
The meeting is scheduled to be held on January 30, 2019, from 9:00 a.m. to 5:00 p.m. and January 31, 2019, from 9:00 a.m. to 5:00 p.m. ET (times are tentative and subject to change). The confirmed times and agenda items for the meeting will be posted on the website for the Advisory Council at
U.S. Department of Health and Human Services, Hubert H. Humphrey Building, Great Hall, 200 Independence Avenue SW, Washington, DC 20201.
The meeting can also be accessed through a live webcast on the day of the meeting. For more information, visit
Dr. Jomana Musmar, Acting Designated Federal Officer, Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services, Room 715H, Hubert H. Humphrey Building, 200 Independence Avenue SW, Washington, DC 20201. Phone: (202) 690-5566; email:
Under Executive Order 13676, dated September 18, 2014, authority was given to the Secretary of HHS to establish the Advisory Council, in consultation with the Secretaries of Defense and Agriculture. Activities of the Advisory Council are governed by the provisions of Public Law 92-463, as amended (5 U.S.C. App.), which sets forth standards for the formation and use of federal advisory committees.
The Advisory Council will provide advice, information, and recommendations to the Secretary of HHS regarding programs and policies intended to support and evaluate the implementation of Executive Order 13676, including the National Strategy for Combating Antibiotic-Resistant Bacteria and the National Action Plan for Combating Antibiotic-Resistant Bacteria. The Advisory Council shall function solely for advisory purposes.
In carrying out its mission, the Advisory Council will provide advice, information, and recommendations to the Secretary regarding programs and policies intended to preserve the effectiveness of antibiotics by optimizing their use; advance research to develop improved methods for combating antibiotic resistance and conducting antibiotic stewardship; strengthen surveillance of antibiotic-resistant bacterial infections; prevent the transmission of antibiotic-resistant bacterial infections; advance the development of rapid point-of-care and agricultural diagnostics; further research on new treatments for bacterial infections; develop alternatives to antibiotics for agricultural purposes; maximize the dissemination of up-to-date information on the appropriate and proper use of antibiotics to the general public and human and animal healthcare providers; and improve international coordination of efforts to combat antibiotic resistance.
The public meeting will be dedicated to hosting stakeholders to explore priority areas that have emerged since the original National Action Plan on Combating Antibiotic Resistant Bacteria was launched in 2015. The meeting agenda will be posted on the Advisory Council website at
Public attendance at the meeting is limited to the available space. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Advisory Council at the address/telephone number listed above at least one week prior to the meeting. For those unable to attend in person, a live webcast will be available. More information on registration and accessing the webcast can be found at
Members of the public will have the opportunity to provide comments prior to the Advisory Council meeting by emailing
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.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, 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 the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning the opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer at (240) 276-1243.
Comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Section 1926 of the Public Health Service Act [42 U.S.C. 300x-26] stipulates that Substance Abuse Prevention and Treatment Block Grant (SABG) funding agreements for alcohol and drug abuse programs for fiscal year 1994 and subsequent fiscal years require states to have in effect a law stating that it is unlawful for any manufacturer, retailer, or distributor of tobacco products to sell or distribute any such product to any individual under the age of 18. This section further requires that states conduct annual, random, unannounced inspections to ensure compliance with the law; that the state submit annually a report describing the results of the inspections, the activities carried out by the state to enforce the required law, the success the state has achieved in reducing the availability of tobacco products to individuals under the age of 18, and the strategies to be utilized by the state for enforcing such law during the fiscal year for which the grant is sought.
Before making an award to a state under the SABG, the Secretary must make a determination that the state has maintained compliance with these requirements. If a determination is made that the state is not in compliance, penalties shall be applied. Penalties ranged from 10 percent of the Block Grant in applicable year 1 (FFY 1997 SABG Applications) to 40 percent in applicable year 4 (FFY 2000 SABG Applications) and subsequent years. Respondents include the 50 states, the District of Columbia, the Commonwealth of Puerto Rico, the U.S. Virgin Islands, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, Palau, Micronesia, and the Marshall Islands. Red Lake Indian Tribe is not subject to tobacco requirements.
Regulations that implement this legislation are at 45 CFR 96.130, are approved by OMB under control number 0930-0163, and require that each state submit an annual Synar report to the Secretary describing their progress in complying with section 1926 of the PHS Act. The Synar report, due December 31 following the fiscal year for which the state is reporting, describes the results of the inspections and the activities carried out by the state to enforce the required law; the success the state has achieved in reducing the availability of tobacco products to individuals under the age of 18; and the strategies to be utilized by the state for enforcing such law during the fiscal year for which the grant is sought. SAMHSA's Center for Substance Abuse Prevention will request an extension of OMB approval of the current report format associated with section 1926 (42 U.S.C. 300x-26) to 2022. Extending OMB approval of the current report format will continue to facilitate consistent, credible, and efficient monitoring of Synar compliance across the states.
Send comments to Summer King, SAMHSA Reports Clearance Officer, 5600 Fishers Lane, Room 15E57-B, Rockville, Maryland 20857, OR email a copy to
Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer at (240) 276-1243.
The Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Substance Abuse Prevention (CSAP) is requesting from the Office of Management and Budget (OMB) approval for the revision of Minority AIDS Initiative (MAI) monitoring tools, which includes both youth and adult questionnaires as well as the quarterly progress report. This revision includes the inclusion of new cohorts, substantial revisions to the youth and adult questionnaires, updates to the data used to estimate response rates and expected numbers of participants by service duration (see Table 1 below).
The cohorts of grantees funded by the MAI and included in this clearance request are:
The target population for the MAI grantees will be at-risk minority adolescents and young adults. All MAI grantees are expected to report their monitoring data using SAMHSA's Strategic Prevention Framework (SPF) to target minority populations, as well as other high risk groups residing in communities of color with high prevalence of Substance Abuse and HIV/AIDS. The primary objectives of the monitoring tools include:
• Assess the success of the MAI in reducing risk factors and increasing protective factors associated with the transmission of the Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), and other sexually-transmitted diseases (STD).
• Measure the effectiveness of evidence-based programs and infrastructure development activities such as: Outreach and training, mobilization of key stakeholders, substance abuse and HIV/AIDS counseling and education, testing, referrals to appropriate medical treatment and/or other intervention strategies (
• Investigate intervention types and features that yield the best outcomes for specific population groups.
• Assess the extent to which access to health care was enhanced for population groups and individuals vulnerable to behavioral health disparities residing in communities targeted by funded interventions.
• Assess the process of adopting and implementing the SPF with the target populations.
Revisions to the monitoring tools include the following:
The following two tools have been added to this data collection, but were approved under OMB No. 0930-0347 with the exception of the new items listed below. Questions removed were non-essential.
In addition to all items listed above, on the youth questionnaire, SAMHSA also removed non-essential questions related to:
The following two tools have been deleted from this data collection:
Revision made per the 60-day comment period:
Written comments and recommendations concerning the proposed information collection should be sent by December 24, 2018 to the SAMHSA Desk Officer at the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB). To ensure timely receipt of comments, and to avoid potential delays in OMB's receipt and processing of mail sent through the U.S. Postal Service, commenters are encouraged to submit their comments to OMB via email to:
Coast Guard, DHS.
Thirty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Request (ICR), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval for reinstatement, without change, of the following collection of information: 1625-0044, Outer Continental Shelf Activities—Title 33 CFR Subchapter N. Our ICR describes the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.
Comments must reach the Coast Guard and OIRA on or before December 24, 2018.
You may submit comments identified by Coast Guard docket number [USCG-2018-0279] to the Coast Guard using the Federal eRulemaking Portal at
(1)
(2)
A copy of the ICR is available through the docket on the internet at
Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.
The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. These comments will help OIRA determine
We encourage you to respond to this request by submitting comments and related materials. Comments to Coast Guard or OIRA must contain the OMB Control Number of the ICR. They must also contain the docket number of this request, [USCG-2018-0279], and must be received by December 24, 2018.
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
OIRA posts its decisions on ICRs online at
This request provides a 30-day comment period required by OIRA. The Coast Guard published the 60-day notice (83 FR 45645, September 10, 2018) required by 44 U.S.C. 3506(c)(2). That Notice elicited no comments. Accordingly, no changes have been made to the Collections.
Federal Emergency Management Agency, DHS.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.
Comments are to be submitted on or before February 21, 2019.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location
You may submit comments, identified by Docket No. FEMA-B-1861, to Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP and are used to calculate the appropriate flood insurance premium
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location
Federal Emergency Management Agency, DHS.
Notice.
This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The
These flood hazard determinations will be finalized on the dates listed in the table below and revise the FIRM panels and FIS report in effect prior to this determination for the listed communities.
From the date of the second publication of notification of these changes in a newspaper of local circulation, any person has 90 days in which to request through the community that the Deputy Associate Administrator for Insurance and Mitigation reconsider the changes. The flood hazard determination information may be changed during the 90-day period.
The affected communities are listed in the table below. Revised flood hazard information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Submit comments and/or appeals to the Chief Executive Officer of the community as listed in the table below.
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
The specific flood hazard determinations are not described for each community in this notice. However, the online location and local community map repository address where the flood hazard determination information is available for inspection is provided.
Any request for reconsideration of flood hazard determinations must be submitted to the Chief Executive Officer of the community as listed in the table below.
The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001
The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
These flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. The flood hazard determinations are in accordance with 44 CFR 65.4.
The affected communities are listed in the following table. Flood hazard determination information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Georgia (FEMA-4400-DR), dated October 14, 2018, and related determinations.
This amendment was issued November 7, 2018.
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 Georgia is hereby amended to
Montgomery and Telfair Counties for Public Assistance.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Florida (FEMA-4399-DR), dated October 11, 2018, and related determinations.
This amendment was issued November 15, 2018.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Florida is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of October 11, 2018.
Okaloosa and Walton Counties for Public Assistance.
Jefferson and Madison Counties for Public Assistance [Categories C-G] (already designated for debris removal and emergency protective measures [Categories A and B], including direct federal assistance under the Public Assistance program).
Franklin, Holmes, Leon, Taylor, Wakulla, and Washington Counties for Public Assistance [Categories C-G] (already designated for Individual Assistance and assistance for debris removal and emergency protective measures [Categories A and B], including direct federal assistance under the Public Assistance program).
Federal Emergency Management Agency, DHS.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.
Comments are to be submitted on or before February 21, 2019.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location
You may submit comments, identified by Docket No. FEMA-B-1864, to Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Georgia (FEMA-4400-DR), dated October 14, 2018, and related determinations.
This amendment was issued November 15, 2018.
Dean Webster, Office of Response and Recovery, Federal Emergency
The notice of a major disaster declaration for the State of Georgia 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 14, 2018.
Hancock and Tattnall Counties for Public Assistance.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households in Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR), in accordance with Federal Regulations. The LOMR will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings. For rating purposes, the currently effective community number is shown in the table below and must be used for all new policies and renewals.
These flood hazard determinations will be finalized on the dates listed in the table below and revise the FIRM panels and FIS report in effect prior to this determination for the listed communities.
From the date of the second publication of notification of these changes in a newspaper of local circulation, any person has 90 days in which to request through the community that the Deputy Associate Administrator for Insurance and Mitigation reconsider the changes. The flood hazard determination information may be changed during the 90-day period.
The affected communities are listed in the table below. Revised flood hazard information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Submit comments and/or appeals to the Chief Executive Officer of the community as listed in the table below.
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
The specific flood hazard determinations are not described for each community in this notice. However, the online location and local community map repository address where the flood hazard determination information is available for inspection is provided.
Any request for reconsideration of flood hazard determinations must be submitted to the Chief Executive Officer of the community as listed in the table below.
The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001
The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
These flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. The flood hazard determinations are in accordance with 44 CFR 65.4.
The affected communities are listed in the following table. Flood hazard determination information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
National Protection and Programs Directorate, DHS.
Announcement of meeting; request for comments.
The National Protection and Programs Directorate (NPPD) announces a public meeting of the President's National Infrastructure Advisory Council (NIAC). To facilitate public participation, NPPD invites public comment on the agenda items to be considered by the NIAC at the meeting, a draft report on catastrophic power outages, and the associated briefing materials for the report.
The NIAC meeting will be held at the Eisenhower Executive Office Building, 1650 Pennsylvania Ave. NW, Washington, DC 20502.
Comments identified by docket number “DHS-2018-0065” may be submitted by any of the following methods:
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Ginger K. Norris, 202-441-5885,
The NIAC is established under Section 10 of E.O. 13231 issued on October 16, 2001. Notice of this meeting is given under the Federal Advisory Committee Act, 5 U.S.C. Appendix (Pub. L. 92-463). The NIAC shall provide the President, through the Secretary of Homeland Security, with advice on the security and resilience of the Nation's critical infrastructure sectors.
The NIAC will meet in an open meeting on December 13, 2018 to
Due to limited seating, requests to attend in person will be accepted and processed in the order in which they are received. Individuals may register to attend the NIAC meeting by sending an email to
While this meeting is open to the public, participation in NIAC deliberations are limited to council members. A public comment period will be held during the meeting from approximately 10:30 a.m.-10:45 a.m. EST. Speakers who wish to comment on the draft catastrophic power outage report must register in advance and can do so by emailing
For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Notice.
This notice establishes operating cost adjustment factors (OCAFs) for project-based assistance contracts issued under Section 8 of the United States Housing Act of 1937 and renewed under the Multifamily Assisted Housing Reform and Affordability Act of 1997 (MAHRA) for eligible multifamily housing projects having an anniversary date on or after February 11, 2019. OCAFs are annual factors used to adjust Section 8 rents renewed under section 515 or section 524 of MAHRA.
Carissa Janis, Program Analyst, Office of Asset Management and Portfolio Oversight, Department of Housing and Urban Development, 451 7th Street SW, Washington, DC 20410; telephone number 202-402-2487 (this is not a toll-free number). Hearing- or speech-impaired individuals may access this number through TTY by calling the toll-free Federal Relay Service at 800-877-8339.
Section 514(e)(2) and section 524(c)(1) of MAHRA (42 U.S.C. 1437f note) require HUD to establish guidelines for the development of OCAFs for rent adjustments. Sections 524(a)(4)(C)(i), 524(b)(1)(A), and 524(b)(3)(A) of MAHRA, all of which prescribe the use of the OCAF in the calculation of renewal rents, contain similar language. HUD has therefore used a single methodology for establishing OCAFs, which vary among states and territories.
MAHRA gives HUD broad discretion in setting OCAFs, referring, for example, in sections 524(a)(4)(C)(i), 524(b)(1)(A), 524(b)(3)(A) and 524(c)(1) simply to “an operating cost adjustment factor established by the Secretary.” The sole limitation to this grant of authority is a specific requirement in each of the foregoing provisions that application of an OCAF “shall not result in a negative adjustment.” Contract rents are adjusted by applying the OCAF to that portion of the rent attributable to operating expenses exclusive of debt service.
The OCAFs provided in this notice are applicable to eligible projects having a contract anniversary date of February 11, 2019 or after and were calculated using the same method as those published in HUD's 2018 OCAF notice published on November 2, 2017 (82 FR 50888). Specifically, OCAFs are calculated as the sum of weighted component cost changes for wages, employee benefits, property taxes, insurance, supplies and equipment, fuel oil, electricity, natural gas, and water/sewer/trash using publicly available indices. The weights used in the OCAF calculations for each of the nine cost component groupings are set using current percentages attributable to each of the nine expense categories. These weights are calculated in the same manner as in the November 2, 2017 notice. Average expense proportions were calculated using three years of audited Annual Financial Statements from projects covered by OCAFs. The expenditure percentages for these nine categories have been found to be very stable over time but using three years of data increases their stability. The nine cost component weights were calculated at the state level, which is the lowest level of geographical aggregation with enough projects to permit statistical analysis. These data were not available for the Western Pacific Islands, so data for Hawaii were used as the best available indicator of OCAFs for these areas.
The best current price data sources for the nine cost categories were used in calculating annual change factors. State-level data for fuel oil, electricity, and natural gas from Department of Energy surveys are relatively current and continue to be used. Data on changes in employee benefits, insurance, property taxes, and water/sewer/trash costs are only available at the national level. The data sources for the nine cost indicators selected used were as follows:
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The sum of the nine cost component percentage weights equals 100 percent of operating costs for purposes of OCAF calculations. To calculate the OCAFs, state-level cost component weights developed from AFS data are multiplied by the selected inflation factors. For instance, if wages in Virginia comprised 50 percent of total operating cost expenses and increased by 4 percent from 2017 to 2018 the wage increase component of the Virginia OCAF for 2019 would be 2.0 percent (50% * 4%). This 2.0 percent would then be added to the increases for the other eight expense categories to calculate the 2019 OCAF for Virginia. For states where the calculated OCAF is less than zero, the OCAF is floored at zero. The OCAFs for 2019 are included as an Appendix to this Notice.
Sections 514 and 515 of MAHRA, as amended, created the Mark-to-Market program to reduce the cost of federal housing assistance, to enhance HUD's administration of such assistance, and to ensure the continued affordability of units in certain multifamily housing projects. Section 524 of MAHRA authorizes renewal of Section 8 project-based assistance contracts for projects without restructuring plans under the Mark-to-Market program, including projects that are not eligible for a restructuring plan and those for which the owner does not request such a plan. Renewals must be at rents not exceeding comparable market rents except for certain projects. As an example, for Section 8 Moderate Rehabilitation projects, other than single room occupancy projects (SROs) under the McKinney-Vento Homeless Assistance Act (42 U.S.C. 11301
This notice sets forth rate determinations and related external administrative requirements and procedures that do not constitute a development decision affecting the physical condition of specific project areas or building sites. Accordingly, under 24 CFR 50.19(c)(6), this notice is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).
This notice does not impact the information collection requirements already submitted to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). In accordance with the Paperwork Reduction Act, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection displays a currently valid OMB control number.
The Catalog of Federal Domestic Assistance Number for this program is 14.195.
Fish and Wildlife Service, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the U.S. Fish and Wildlife Service, are proposing to renew an information collection with revisions.
Interested persons are invited to submit comments on or before December 24, 2018.
Send written comments on this information collection request (ICR) to the Office of Management and Budget's Desk Officer for the Department of the Interior by email at
To request additional information about this ICR, contact Madonna L. Baucum, Service Information Collection Clearance Officer, 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.
A
Occidental Petroleum Corporation provided comments on whether PECE is necessary to the proper functions of the Service, whether we will use the information in a timely manner, and how to enhance the information being collected. They stated that PECE is very important to encourage voluntary conservation efforts prior to listing decisions such that listing may not be necessary. They offered three suggestions to improve information collection in the context of specific listing decisions:
(1) Ensure that we are collecting the right types of information by considering what will be useful in predicting future conservation actions and results, and articulating the factors we think will inform such predictions,
(2) Ensure that we have the ability to update our listing decisions up until the last minute regarding current information about conservation efforts, and
(3) Ensure that PECE analyses are cumulative and include all qualifying conservation efforts together rather than in isolation.
Chelan Public Utility District No. 1 commented that it finds PECE useful because it encourages aggregation of information about conservation efforts, which can provide notice to permit applicants and other entities possibly affected by a listing, both of the listing and the efforts. It can also encourage entities to participate in conservation efforts, which can be meaningful for species. It finds that encouraging conservation efforts is consistent with the ESA and benefits species.
We are again 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 Service; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Service enhance the quality, utility, and clarity of the
Comments that you submit in response to this notice are a matter of public record. 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 publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
The Policy for Evaluation of Conservation Efforts When Making Listing Decisions (PECE) (68 FR 15100, March 28, 2003) encourages the development of conservation agreements or plans and provides certainty about the standard that an individual conservation effort must meet in order for us to consider whether it is likely to make a difference in a species' status. PECE applies to “formalized conservation efforts” that have not been implemented or have been implemented but have not yet demonstrated if they are effective at the time of a listing decision.
Under PECE, formalized conservation efforts are defined as conservation efforts (specific actions, activities, or programs designed to eliminate or reduce threats or otherwise improve the status of a species) identified in a conservation agreement, conservation plan, management plan, or similar document. To assist us in evaluating a formalized conservation effort under PECE, we collect information such as conservation plans, monitoring results, and progress reports. The development of any agreement or plan is voluntary. There is no requirement that the individual conservation efforts included in such documents be designed to meet the standard in PECE. The PECE policy is posted on our Candidate Conservation website at
We are not reporting an increase in burden with this renewal, although we revised the collection to include burden for individuals, businesses, and not-for-profit organizations who may develop agreements/plans or may agree to implement certain conservation efforts identified in a State agreement or plan. Previously, we reported all burden estimates as government, although it was possible to receive submissions from individuals and private sector respondents. This submission breaks their burden out separately, with a placeholder of one submission for each category, to account for the rare occasion that we may receive a submission from these additional respondent categories.
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. Geological Survey, Interior.
Notice of public meeting.
In accordance with the Federal Advisory Committee Act of 1972, the U.S. Geological Survey (USGS) is publishing this notice to announce that a Federal Advisory Committee meeting of the National Geospatial Advisory Committee will take place.
The meeting will be held on Thursday, December 6, 2018 from 1:00 p.m. to 4:30 p.m. (Eastern Standard Time).
The meeting will be held via web conference and teleconference. Send your comments to Group Federal Officer by email to
Mr. John Mahoney, Federal Geographic Data Committee, U.S. Geological Survey, 909 First Avenue, Suite 800, Seattle, WA 98104; by email at
This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552B, as amended), and 41 CFR 102-3.140 and 102-3.150.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Bureau of Indian Affairs, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Indian Education (BIE) are proposing a new information collection to gain an understanding of processes and practices within BIE schools.
Interested persons are invited to submit comments on or before January 22, 2019.
Send your comments on this information collection request (ICR) by mail to The Bureau of Indian Education, 1011 Indian School Road NW, Suite 332, Albuquerque, NM 87104; or by email to Veronica Lane,
To request additional information about this ICR, contact Veronica Lane 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
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
Bureau of Indian Affairs, Interior.
Notice.
The Department of the Interior (Department) gives notice that the Assistant Secretary-Indian Affairs (AS-IA) proposes to determine that the petitioner, Southern Sierra Miwuk Nation (SSM), is not an Indian Tribe within the meaning of Federal law. This notice is based on a determination that SSM does not meet one of the seven mandatory criteria for a government-to-government relationship with the United States. This proposed finding is based on only one criterion.
Comments on this proposed finding (PF) are due on or before May 22, 2019. We must receive any request for a technical assistance meeting by January 22, 2019.
Please address comments on the PF or requests for a copy of the report to the Department of the Interior, Office of the Assistant Secretary-Indian Affairs, Attn: Office of Federal Acknowledgment, 1849 C Street NW, MS-4071 MIB, Washington, DC 20240. Parties who make comments on the PF must also provide a copy of their comments to the petitioner.
R. Lee Fleming, Director, Office of Federal Acknowledgment (OFA), (202) 513-7650.
Pursuant to 25 CFR 83.10(h), the Department gives notice that the AS-IA proposes to determine that the Southern Sierra Miwuk Nation (SSM, Petitioner #82), c/o William H. Leonard, 4630 Ben Hur Road, Mariposa, California 95338, is not an Indian Tribe within the meaning of the Federal law. This notice is based on a preliminary finding that the petitioner fails to satisfy one of the seven mandatory criteria for acknowledgement set forth in 25 CFR 83.7(a) through (g), and thus, does not meet the requirements for a government-to-government relationship with the United States.
The Department received a letter of intent from the petitioner under the name “American Indian Council of Mariposa County” (AICMC) on April 24, 1982, and designated it Petitioner #82. The petitioner submitted a narrative and partial documentation on April 19, 1984. The Department replied with an “obvious deficiency” (OD) review letter on May 1, 1985. The petitioner responded with documentation on December 12, 1986. At the request of the petitioner, the Department sent a second OD review letter on April 11, 1988. The Department received the petitioner's response on January 16, 1998. The Department then placed Petitioner #82 on the “Ready, Waiting for Active Consideration” list.
Active consideration began on November 1, 2010, after which the Department asked for an updated membership list and any other materials within 60 days (70 FR 16514). The petitioner requested an “extension of time to submit documentation,” and the Department received the petitioner's submission on February 8, 2011, containing documentation, meeting minutes, membership list, articles, newspapers, and governing documents.
During review of Petitioner #82's documented petition, OFA identified technical issues with the petitioner's membership files that needed to be resolved in order to complete the review for the PF. For this reason, the AS-IA extended the original due date for issuance of the PF, from November 1, 2011 to April 30, 2012. During further review, additional technical issues with the petitioner's membership vital records arose, and the AS-IA found good cause to suspend the issuance of the PF under 83.10(g).
On July 31, 2015, the Department issued a final rule that revised the acknowledgment regulations and provided the petitioner the opportunity to choose to complete the evaluation either under the revised 2015 regulations or under the 1994 regulations (80 FR 37862-37895). Petitioner #82 decided to continue with the review of its petition under the 1994 regulations. Active consideration resumed, with the AS-IA ultimately extending the deadline for this PF to November 16, 2018.
Criterion 83.7(b) requires that “a predominant portion of the petitioning group comprises a distinct community and has existed as a community from historical times until the present.” Section 83.1 defines “Community” as: Any group of people which can demonstrate that consistent interactions and significant social relationships exist within its membership and that its members are differentiated from and identified as distinct from nonmembers..
Evidence in the record shows involvement by some members of the petitioner in group activities, but not by a predominant portion of the membership. Events sponsored by the formal organization are attended by some of the petitioner's members, but also by non-Indians and non-Miwok Indians (some of whom may be closely related to the petitioner but who are enrolled in federally recognized Tribes). Participation in these activities appears to include some members from various families, but it is unclear to what extent this participation represents a cross-section of the entire membership. The record contains very little information regarding how often members interact with each other outside of the functions organized by the group's leadership. The materials and interviews contained few descriptions of members from multiple families socializing at birthday parties, baby showers, graduations, anniversaries, or other events not sponsored by the group's governing body. There is also little to no discussion in the interviews or in any of the documents in the record of members informally looking after each other's children, taking in other members if they were rendered homeless, helping other members to secure employment, or aiding other members in times of sickness or financial hardship.
The evidence in the record is insufficient to demonstrate that Petitioner #82 meets the criterion 83.7(b), one of the seven mandatory criteria of the regulations for a determination that the petitioning group is an Indian Tribe. In accordance with the regulations, the failure to meet all seven criteria requires a determination that the petitioning group is not an Indian Tribe within the meaning of Federal law.
According to the AS-IA OFA; Guidance and Direction Regarding Internal Procedures of May 23, 2008:
If during the evaluation of a petition on active consideration it becomes apparent that the petitioner fails on one criterion, or more, under the reasonable likelihood of the validity of the facts standard, OFA may prepare a proposed finding or final determination not to acknowledge the group on the failed criterion or criteria alone, setting forth the evidence, reasoning, and analyses that form the basis for the proposed decision. (73 FR 30146-30148)
The burden of providing sufficient evidence under the criteria in the regulations rests with the petitioner (25 CFR 83.5(c)). Because Petitioner #82 has not met criterion § 83.(b) as a distinct community, it is not necessary, at this time, for the Department to make conclusions regarding the other six mandatory criteria.
Additionally, due to the fact that the petitioner fails to meet the requirements of 83.7(b) (“the present”), the Department considers it unnecessary to conduct an analysis whether a predominant portion of the group comprised a distinct community and existed as a community from historical times. If additional evidence is provided after the PF is published, the Department may find it necessary to conduct an analysis of community from historical times to the present.
The PF is based on the evidence currently in the record. Additional evidence may be submitted during the comment period that follows publication of this finding. If new evidence provided during the comment period results in a reversal of this conclusion, the AS-IA will issue an amended PF evaluating all seven criteria. (73 FR 30146-30148)
Publication of this notice of the PF in the
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal information from public review, we cannot guarantee that we will be able to do so.
Bureau of Land Management, Interior. United States Forest Service, Agriculture.
Notice of availability.
In accordance with the National Environmental Policy Act of 1969 (NEPA), as amended, and the Federal Land Policy Management Act of 1976, as amended, the Bureau of Land Management (BLM) and the Forest Service (USFS) Caribou-Targhee National Forest, have prepared a Draft Environmental Impact Statement (EIS) for the proposed Dairy Syncline Phosphate Mine Project (Project), and by this Notice announce the opening of the comment period.
To ensure consideration, the Agencies must receive written comments on the Dairy Syncline Mine Project Draft EIS by February 21, 2019. The BLM will announce any future public meetings and any other public involvement activities at least 15 days in advance on our ePlanning website,
The public may submit comments related to the Dairy Syncline Mine Project Draft EIS by any of the following methods:
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• BLM Land Use Planning and NEPA Register:
• Caribou-Targhee National Forest Current and Recent Projects
Bill Stout, BLM Pocatello Field Office, 4350 Cliffs Drive, Pocatello, ID 83204; phone 208-236-6367; email:
The BLM, as the Federal mineral lease administrator, is the lead agency, and the USFS is the co-lead agency for preparation of the Draft EIS, which includes several alternatives. The Idaho Department of Environmental Quality, the Idaho Department of Lands, the U.S. Army Corps of Engineers, and the Idaho Governor's Office of Energy and Mineral Resources are cooperating agencies. J.R. Simplot Company (Simplot) submitted a proposed Mine and Reclamation Plan application for agency consideration to extract phosphate rock from the Dairy Syncline leases (IDI-28115 and IDI-0258) located approximately 14 miles east of Soda Springs, in southeastern Caribou County, Idaho. Simplot submitted its original Dairy Syncline Mine and Reclamation Plan (M&RP) in 2008 and a revised M&RP was submitted in 2013.
The proposal would disturb a total of 2,830 acres as described in the Draft EIS. In one of the alternatives and in order to accommodate the proposed tailings pond, the BLM is considering acceptance of a land donation and offering a land sale, and the USFS is considering a land exchange and acceptance of a land donation. The BLM further describes these two land tenure adjustments in the Draft EIS. The BLM land tenure adjustment would require an amendment to the current Pocatello Resource Management Plan and the land exchange would require a Forest Plan Amendment.
In addition, the BLM and USFS propose seven enlargements (lease modifications) to the existing leases in order to maximize recovery of the leased phosphate resource. Further, eight USFS Special Use Authorizations would be necessary.
The Draft EIS analyzes numerous action alternatives, including an alternate access route, reduced BLM and USFS land tenure adjustments, and an alternative to reduce impacts to water resources. The agency Preferred Alternative is a modified form of the Proposed Action, which includes reducing the size of land tenure adjustments and adopting elements of the selective waste rock handling alternative. The modifications made to the Proposed Action (resulting in the Preferred Alternative) would result in a net gain of Federal land acreage and the fewest impacts to surface and groundwater of all the action alternatives.
A Notice of Intent to prepare this EIS was published in the
To facilitate an understanding of the project and commenting on the Draft EIS, the lead agencies plan to hold public meetings in Soda Springs, Georgetown, and Pocatello, Idaho. Meetings will be announced as previously described and will be in the open-house format, with displays explaining the Project and a forum for commenting on the Project. Written and electronic comments regarding the Draft EIS should be submitted by February 21, 2019.
The portions of the Project related to USFS decisions are subject to the USFS objection process. Due to the need for a Revised Forest Plan amendment, this proposed Project is subject to the predecisional administrative review process described in 36 CFR 218 subparts A and B and 36 CFR 219 subpart B. Only those who provide comments during this comment period or who have previously submitted specific written comments on the Proposed Action, either during scoping or other designated opportunities for public comment, will be eligible as objectors (see 36 CFR 218.5 (a) and 219.53 (a)).
Before including your 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.
National Park Service, Interior.
Meeting notice.
In accordance with the Federal Advisory Committee Act of 1972, the National Park Service (NPS) is hereby giving notice that the Na Hoa Pili O Kaloko-Honokohau National Historical Park Advisory Commission (Commission) will meet as indicated below.
The Commission will meet on Friday, December 7, 2018, from 9:30 a.m. to 2:30 p.m., with a public comment period at 1:00 p.m. (Hawaii Standard Time).
The meeting will be held at the Kaloko-Honokohau National Historical Park Kaloko Picnic area. The Kaloko-Honokohau National Historical Park is located in Kailua Kona, Hawaii 96740.
Jeff Zimpfer, Environmental Protection Specialist, Kaloko-Honokohau National Historical Park, 73-4786 Kanalani Street, #14, Kailua Kona, Hawaii 96740, telephone (808) 329-6881, ext. 1500, or email
The park was established by section 505(a) of Public Law 95-625, November 10, 1978, and the Commission was established by section 505(f) of that same law. The Commission was re-established by Title VII, Subtitle E, section 7401 of Public Law 111-11, the Omnibus Public Land Management Act of 2009, March 30, 2009. The Commission's current termination date is December 31, 2018.
The purpose of the Commission is to advise the Director of the National Park Service with respect to the historical, archeological, cultural, and interpretive programs of the park. The Commission is to afford particular emphasis to the quality of traditional native Hawaiian cultural practices demonstrated in the park.
1. Approval of Agenda
2. Chairman's Report
3. Superintendent's Report
4. Subcommittee Reports
5. Commission Recommendations
a. In absence of the Commission, what cultural center activities should the NPS and the community focus on in the short-term, medium term, and long-term to carry out the mission of the Park?
b. In the absence of the Commission, how should the NPS engage with the community for insights, feedback, and suggestions to ensure the park's mission is fulfilled as detailed in the park's enabling legislation?
6. Public Comments
All meetings are open to the public. Interested persons may make oral/written presentations to the Commission or file written statements. Such requests should be made to the Superintendent at least seven days prior to the meetings.
5 U.S.C. Appendix 2.
National Park Service, Interior.
Meeting notice.
In accordance with the Federal Advisory Committee Act of 1972, the National Park Service (NPS) is hereby giving notice that the Gateway National Recreation Area Fort Hancock 21st Century Advisory Committee will meet as indicated below.
The meeting will take place on Friday, December 7, 2018 from 9:00 a.m. until 3:00 p.m., with a public comment period at 11:30 a.m. (Eastern).
The meeting will be held at the Northeast Fisheries Science Center James J. Howard Marine Sciences Laboratory, 74 Magruder Road, Sandy Hook Highlands, New Jersey 07732.
Daphne Yun, Acting Public Affairs Officer, Gateway National Recreation Area, 210 New York Avenue, Staten Island, New York 10305, or by telephone (718) 815-3651, or by email
The Committee was established on April 18, 2012, by authority of the Secretary of the Interior (Secretary) under 54 U.S.C. 100906, and is regulated by the Federal Advisory Committee Act. The Committee provides advice to the Secretary, through the Director of the National Park Service, on matters relating to the Fort Hancock Historic District of Gateway National Recreation Area. All meetings are open to the public.
The Committee website,
Due to time constraints during the meeting, the Committee is not able to read written public comments submitted into the record. Individuals or groups requesting to make oral comments at the public Committee meeting will be limited to no more than five minutes per speaker. All comments will be made part of the public record and will be electronically distributed to all Committee members.
5 U.S.C. Appendix 2.
National Park Service, Interior.
Notice of information collection request; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the National Park Service (NPS) are proposing to renew an information collection with revisions.
Interested persons are invited to submit comments on or before January 22, 2019.
Send your comments on this Information Collection Request (ICR) by mail to Phadrea Ponds, Acting, Information Collection Clearance Officer, National Park Service, 1201 Oakridge Drive, Fort Collins, CO 80525 (mail); or
To request additional information about this IC, contact Kriston Barnes, Natural Resource Stewardship and Science Directorate, National Park Service, 1201 Oakridge Dr., Suite 200, Fort Collins, CO 80525 (mail);
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 information collection request (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 NPS; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the NPS enhance the quality, utility, and clarity of the information to be collected; and (5) how might the NPS 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 IC. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that 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 of information collection request; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the National Park Service (NPS) are proposing to renew an information collection.
Interested persons are invited to submit comments on or before January 22, 2019.
Send comments on this Information Collection Request (ICR) to Phadrea D. Ponds, Information Collection Clearance Officer, National Park Service, 1201 Oakridge Drive, Fort Collins, CO 80525; or by email to
To request additional information about this ICR, contact Patty Henry by email at
In accordance with the Paperwork Reduction Act of 1995, we provide the
We are soliciting comments on the proposed information collection request (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 NPS, (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the NPS enhance the quality, utility, and clarity of the information to be collected; and (5) how might the NPS 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. 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.
All interested parties must inquire by letter or email about the eligibility of properties to be considered for NHL designation. The inquiry will include the name and location of property, brief historical summary of property, and brief description of property. If determined eligible for consideration the respondent will use NPS Form 10-934 (National Historic Landmarks Nomination Form) to nominate a property. The form is used to collect the following information: (1) Name and location of property; (2) significance data related to the property; (3) any withholding of sensitive information; (4) geographical data; (5) significance statement and discussion about the property; (6) property description and statement of integrity; (7) major bibliographic references; and (8) name, organization, address, phone number, and email of the person completing the form.
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 Reclamation, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Reclamation (Reclamation), are proposing to renew an information collection with revisions.
Interested persons are invited to submit comments on or before January 22, 2019.
Send your comments on this information collection request (ICR) by mail to Mr. Paul Matuska, Bureau of Reclamation, Boulder Canyon Operations Office, Water Accounting and Verification Group, LC-4200, P.O. Box 61470, Boulder City, NV 89006; or by email to
To request additional information about
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 Reclamation; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might Reclamation enhance the quality, utility, and clarity of the information to be collected; and (5) how might Reclamation 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
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined to affirm-in-part, modify-in-part, reverse-in-part, and strike certain portions of a final initial determination (“ID”) of the presiding administrative law judge (“ALJ”). Accordingly, the Commission has determined that a violation of section 337 has occurred in the above-captioned investigation, and has issued a limited exclusion order directed against infringing two-way radio products and cease and desist orders directed against two domestic respondents found in violation. The Commission has terminated the investigation.
Clint Gerdine, Esq., Office of the General Counsel, U.S. International
The Commission instituted this investigation on May 3, 2017, based on a complaint filed on behalf of Motorola Solutions, Inc. (“Motorola”) of Chicago, Illinois. 82 FR 20635-36. The complaint alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, by reason of infringement of certain claims of U.S. Patent Nos.: 8,116,284 (“the '284 patent”); 7,369,869 (“the '869 patent”); 7,729,701 (“the '701 patent”); 8,279,991 (“the `991 patent”); 9,099,972 (“the '972 patent”); 8,032,169 (“the '169 patent”); and 6,591,111 (“the '111 patent”). The Commission's Notice of Investigation named as respondents Hytera Communications Corp. Ltd. of Shenzhen, China; Hytera America, Inc. (“Hytera America”) of Miramar, Florida; and Hytera Communications America (West), Inc. (“Hytera Communications America”) of Irvine, California (collectively, “Hytera”). The Office of Unfair Import Investigations is not participating in the investigation.
On September 18, 2017, the Commission issued notice of its determination not to review an ID (Order No. 10) terminating the investigation as to: (1) Claims 2, 5, 10, and 16 of the '284 patent; (2) claims 2-3, 8, 12, 14-15, 20, 22-24, and 30 of the '169 patent; (3) claims 5, 8, 11-14, 18, and 22 of the '869 patent; (4) claims 3, 5, 8-10, 15, and 17-18 of the '701 patent; (5) claim 3 of the '972 patent; and (6) claims 3-5, 8-10, and 14 of the '111 patent. On October 17, 2017, the Commission issued notice of its determination not to review an ID (Order No. 16) terminating the investigation as to claim 10 of the '869 patent. On November 14, 2017, the Commission issued notice of its determination not to review an ID (Order No. 19) terminating the investigation as to: (1) Claims 1, 4, 12, and 18 of the '284 patent; (2) claims 4, 13, 16, and 25 of the '169 patent; (3) claims 3-4, 9, 19-20, and 23-24 of the '869 patent; (4) claims 2, 4, and 14 of the '701 patent; (5) claims 4 and 8 of the '972 patent; (6) claims 6 and 12 of the '111 patent; and (7) claim 19 of the '991 patent for the purposes of satisfying the technical prong of the domestic industry requirement.
On December 4, 2017, the Commission issued notice of its determination not to review an ID (Order No. 21) terminating the investigation as to claims 5 and 18 of the '169 patent. On January 3, 2018, the Commission issued notice of its determination not to review an ID (Order No. 23) terminating the investigation as to: (1) The '111 and '169 patents; (2) claims 2 and 7 of the '869 patent; and (3) claims 7-8 and 19 of the '284 patent. On the same date, the Commission issued notice of its determination not to review an ID (Order No. 24) terminating the investigation as to claim 1 of the '701 patent. On February 6, 2018, the Commission issued notice of its determination not to review an ID (Order No. 31) terminating the investigation as to the following patent claims: (1) Claim 13 of the '701 patent; (2) claim 6 of the '284 patent; and (3) claim 1 of the '972 patent. On February 26, 2018, the Commission issued notice of its determination not to review an ID (Order No. 40) terminating the investigation as to the '972 patent.
On January 26, 2018, the ALJ issued Order No. 38 which granted Motorola's motion
On July 17, 2018, Motorola and Hytera petitioned for review of the final ID. Hytera's petition for review included a petition for review of Order Nos. 38 and 47. On July 25, 2018, Motorola and Hytera each filed a response in opposition to the other party's petition for review. On August 6 and 7, 2018, respectively, Hytera and Motorola filed statements on the public interest. On August 10, 2018, the Commission received statements on the public interest from interested non-parties.
On September 4, 2018, the Commission issued notice of its determination to review the following: (1) Order No. 38's finding that Hytera's licensing defense is precluded; (2) Order No. 47's finding that certain expert testimony from Hytera at the evidentiary hearing is stricken; (3) the ID's finding that Hytera's accused redesigned products infringe claims 9 and 13-15 of the '284 patent under the doctrine of equivalents; (4) the ID's application of an adverse inference against Hytera as part of the finding of indirect infringement; and (5) the ID's finding that insufficient record evidence exists to make a conclusive determination as to whether any redesigned products infringe the '701 patent and ID's lack of an express finding on this issue with respect to the '869 or '991 patent. The Commission determined not to review the remainder of the final ID. The determinations made in the final ID that were not reviewed became final determinations of the Commission by operation of rule.
On September 18 and 25, 2018, respectively, complainant and respondents each filed a brief and a reply brief on all issues for which the Commission requested written submissions. The Commission also received written submissions on the public interest from interested non-parties on September 18, 2018.
Having reviewed the record in this investigation, including the final ID and the parties' written submissions, the Commission has determined to affirm-in-part, reverse-in-part, modify-in-part, and strike certain portions of the final ID's findings under review. Specifically, the Commission has: (1) Reversed the ID's finding that Hytera's accused redesigned products infringe claims 9 and 13-15 of the '284 patent under the doctrine of equivalents; (2) struck the first and second sentences of the fourth paragraph on page 8 in Order No. 38, and struck the third sentence of this paragraph “There is no analysis” and substituted “There is no analysis in Dr. Akl's Report,” and struck the second sentence of the first full paragraph on page 9 of Order No. 38; (3) affirmed Order No. 47 and supplemented and clarified its reasoning; (4) took no position on the ID's drawing of an adverse inference against Hytera as part of its finding of indirect infringement; and (5) found that Hytera's redesigned products do not infringe the '701, '869, or '991 patents. Accordingly, the Commission has found that there is a violation of section 337 with respect to the '991, '869, and '701 patents.
Having found a violation of section 337 as to these patents, the Commission has made its determination on the issues of remedy, the public interest, and bonding. The Commission has determined that the appropriate form of relief is (1) a limited exclusion order prohibiting the unlicensed entry of two-way radio equipment and systems, related software and components thereof that infringe one or more of claims 1, 6, 17, and 21 of the '869 patent; claims 1 and 11 of the '701 patent; and claims 7-8 of the '991 patent, which are manufactured abroad by or on behalf of, or are imported by or on behalf of, Hytera, or any of its affiliated companies, parents, subsidiaries, or other related business entities, or their successors or assigns; and (2) cease and desist orders prohibiting Hytera America or Hytera Communications America from conducting any of the following activities in the United States: Importing, selling, marketing, advertising, distributing, offering for sale, transferring (except for exportation), and soliciting U.S. agents or distributors for two-way radio equipment and systems, related software and components thereof that infringe one or more of claims 1, 6, 17, and 21 of the '869 patent; claims 1 and 11 of the '701 patent; and claims 7-8 of the '991 patent.
The Commission further determined that the public interest factors enumerated in section 337(d)(1) and (f)(1) (19 U.S.C. 1337(d)(1), (f)(1)) do not preclude issuance of the limited exclusion order or cease and desist orders. Finally, the Commission determined that a bond of 44 percent of the entered value of the covered products is required to permit temporary importation during the period of Presidential review (19 U.S.C. 1337(j)). The Commission has also issued an opinion explaining the basis for the Commission's action. The Commission's order and opinion were delivered to the President and to the United States Trade Representative on the day of their issuance. The investigation is terminated.
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.
United States International Trade Commission.
Notice of investigation and scheduling of a public hearing.
Following receipt on November 9, 2018, of a request from the United States Trade Representative (USTR) for a report containing advice and an assessment, the Commission instituted Investigation Nos. TA-131-044 and TPA-105-005,
December 6, 2018: Deadline for filing requests to appear at the public hearing.
December 10, 2018: Deadline for filing prehearing briefs and statements.
December 18, 2018: Public hearing.
January 4, 2019: Deadline for filing post-hearing briefs and submissions.
January 4, 2019: Deadline for filing all other written statements.
March 19, 2019: Transmittal of Commission report to the USTR.
All Commission offices, including the Commission's hearing rooms, are located in the U.S. International Trade Commission Building, 500 E Street SW, Washington, DC. All written submissions should be addressed to the Secretary, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. The public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at
Project Leader Diana Friedman (202-205-3433 or
More specifically, the USTR, under authority delegated by the President and
In addition, the USTR requested that the Commission prepare an assessment, as described in section 105(a)(2)(B)(i)(III) of the Bipartisan Congressional Trade Priorities and Accountability Act of 2015, of the probable economic effects of eliminating tariffs on imports from the EU of those agricultural products described in the list attached to the USTR's request letter on (i) industries in the United States producing the products concerned, and (ii) the U.S. economy as a whole. The USTR's request letter and list of agricultural products are posted on the Commission's website at
For the purposes of these analyses, the USTR requested that the Commission assume that the United Kingdom will no longer be a Member State of the EU. The USTR indicated that those sections of the Commission's report that relate to the advice and assessment of probable economic effects will be classified. The USTR also indicated that he considers the Commission's report to be an interagency memorandum that will contain pre-decisional advice and be subject to the deliberative process privilege. As requested, the Commission will provide its report to USTR as soon as possible, which is March 19, 2019.
The Commission may include some or all of the confidential business information submitted in the course of this investigation in the report it sends to the USTR. Additionally, all information, including confidential business information, submitted in this investigation may be disclosed to and used: (i) By the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel (a) for cybersecurity purposes or (b) in monitoring user activity on U.S. government classified networks. The Commission will not otherwise disclose any confidential business information in a way that would reveal the operations of the firm supplying the information.
By order of the Commission.
Employment and Training Administration, Labor.
Notice.
Sections 3302(c)(2)(A) and 3302(d)(3) of the FUTA provide that employers in a State that has outstanding advances under Title XII of the Social Security Act on January 1 of two or more consecutive years are subject to a reduction in credits otherwise available against the FUTA tax for the calendar year in which the most recent such January 1 occurs, if advances remain on November 10 of that year. Further, Section 3302(c)(2)(C) of FUTA provides for an additional credit reduction for a year if a State has outstanding advances on five or more
California and the United States Virgin Islands were potentially liable for the additional credit reduction under Section 3302(c)(2)(C) of FUTA and applied for the available waiver. It has been determined that each one met all of the criteria of the section necessary to qualify for the waiver of the additional credit reduction. Further, the additional credit reduction of Section 3302(c)(2)(B) is zero for California and the Virgin Islands for 2018. California repaid its outstanding advances prior to November 10, 2018; hence there will be no FUTA credit reduction for the State's employers. Employers in the Virgin Islands will have no additional credit reduction applied for calendar year 2018. However, as a result of having outstanding advances on each January 1 of 2010 through 2018 as well as on November 10, 2018, employers in the Virgin Islands are subject to a FUTA credit reduction of 2.4 percent in 2018.
Legal Services Corporation.
Notice.
The Legal Services Corporation (LSC) issues this Notice describing the conditions for submitting a Letters of Intent (LOI) to Apply for 2019 Pro Bono Innovation Fund grants. This notice and application information are posted at
Letters of Intent must be submitted by Wednesday, January 23, 2019 by 11:59 p.m. Eastern Time.
Letters of Intent must be submitted electronically through
For more information about current Pro Bono Innovation Fund projects, please contact Mytrang Nguyen, Program Counsel, (202) 295-1564 or
The Legal Services Corporation (LSC) issues this Notice describing the conditions for submitting a Letter of Intent to Apply (LOI) for 2019 Pro Bono Innovation Fund grants. This notice and application information are posted at
Since 2014, Congress has provided an annual appropriation to LSC “for a Pro Bono Innovation Fund.”
LSC sought these funds based on the 2012 recommendation of the LSC Pro Bono Task Force. Since its inception, the Pro Bono Innovation Fund has advanced LSC's goal of increasing the quantity and quality of legal services by funding projects that more efficiently and effectively involve pro bono volunteers in serving the critical unmet legal needs of LSC-eligible clients. In 2017, LSC built on these successes by creating three funding categories to better focus on innovations serving unmet and well-defined client needs (Project Grants), on building comprehensive and effective pro bono programs through new applications of existing best practices (Transformation Grants), and on providing continued development support for the most promising innovations (Sustainability Grants).
To be eligible for the Pro Bono Innovation Fund's Project, Sustainability, and Transformation grants, Applicants must be current grantees of LSC Basic Field-General, Basic Field-Migrant, or Basic Field-Native American grants. In addition, Sustainability Grant Applicants must also be a former or current Pro Bono Innovation Fund grantee from the FY17 grant making cycle.
Pro Bono Innovation Fund grants develop, test, and replicate innovative pro bono efforts that can enable LSC grantees to use pro bono volunteers to serve larger numbers of low-income clients and improve the quality and effectiveness of the services provided. The key goals of the Pro Bono Innovation Fund are to:
1. Address gaps in the delivery of legal services to low-income people;
2. Engage more lawyers and other volunteers in pro bono service;
3. Develop, test, and replicate innovative pro bono efforts.
The goal of Pro Bono Innovation Fund
• Community-based partnerships, like the Medical-Legal Partnership of Community Legal Aid, Inc. (MA) or the school-based clinic of Legal Aid of West Virginia, Inc., that work with law firms to provide legal services where clients are located;
• Court-based partnerships, like those at Legal Action of Wisconsin, Inc., and Legal Services Law Line of Vermont, Inc., that use pro bono volunteers to provide same-day, in-court representation and legal assistance;
• An “emeritus” project at The Legal Aid Society of Cleveland (LASC) that provides transitioning and retired attorneys with varied and substantive opportunities to support the LASC's advocates and clients;
• A neighborhood-based project at Legal Aid of Western Missouri that engages transactional attorneys to assist clients in distressed and underserved communities.
The goal of Pro Bono Innovation Fund
Pro Bono Innovation Fund
The availability of funds for Pro Bono Innovation Fund grants for FY 2019 depends on LSC's appropriation. LSC is currently operating under a Continuing Resolution for FY 2019 which funds the federal government through December 7, 2018. The Continuing Resolution maintains funding at $410 million. Pro Bono Innovation Fund grant decisions for FY 2019 will be made in the summer of 2019. LSC anticipates knowing the total amount available for Pro Bono Innovation Fund grants before August.
In FY 2018, LSC received an appropriation of $4.5 million, of which $4.25 million was available for direct grants to support Pro Bono Innovation Fund projects. In 2018, fifteen Pro Bono Innovation Fund applications received funding with a median funding amount of $293,650. There is no maximum amount for Pro Bono Innovation Fund requests that are within the total funding available.
LSC will not designate fixed or estimated amounts for the three different funding categories and will make grant awards for the three categories within the total amount of funding available.
Pro Bono Innovation Fund grant awards will cover an 18- to 24-month period. Applicants for
LSC is committed to reviewing all Pro Bono Innovation Fund grant applications in a timely and thorough manner. Applicants must first submit a Letter of Intent (LOI) to Apply for Funding to LSC by January 23, 2019 to be considered for a grant. After review by LSC Staff, LSC's President makes the final decision on which applicants will be asked to submit a detailed, full application due to LSC in April. Applicants will be notified of invitations to full application by February 2019. Once LSC has received a full application from a selected applicant, the application will undergo a rigorous review by LSC staff and external subject matter experts. LSC's President makes the final decision on funding for the Pro Bono Innovation Fund.
LSC may consider an LOI after the deadline, but only if the Applicant has submitted an email to
The LOI should succinctly summarize the information requested for the category of funding the applicant seeks. A complete LOI consists of: (1) A narrative that responds to the questions for the funding category; and (2) a budget form. Applicants must submit the LOI electronically using the LSC Grants online system found at
The LOI narrative should be a Word or PDF document submitted in the LSC Grants system.
Applicants may submit multiple LOIs under the same or different funding category. If applying for multiple grants, applicants should submit a separate LOI in LSC Grants for each funding request.
The LOI Narrative for
a.
• The specific client need and challenge or opportunity in the pro bono delivery system that the project will address.
• The goals and objectives of the project, the activities that make up the project, and how those activities will
• Strong indication of volunteer interest in and support for the project.
• The expected impact of the project. This should include a brief explanation of the changes and outcomes that will be created as a result of the project.
• The proposed strategies that are innovative or the best practices being replicated, including a brief discussion of how these strategies or best practices were identified.
b.
• The qualifications and relevant experience of the proposed project team, any proposed partner organizations, and your organization.
• The role of your organization's executive management in the design and implementation of the project.
c.
• Estimated total project cost. This includes the estimate for the Pro Bono Innovation Fund requested amount and other in-kind or cash contributions to support the project. Your narrative should provide a breakdown of the major project expenses including, but not limited to, personnel, project expenses, contracts or sub-grants, etc., and how each expense supports the project design.
• For expenses related to personnel, please indicate how many and which positions will be fully or partially funded by the proposed grant.
• A list of any anticipated contributions, both in-kind and monetary, from all partners involved in the project.
• A list of key partners who will receive Pro Bono Innovation Fund funding, including their roles and the estimated dollar amount or percent of budget assigned to each partner.
The LOI Narrative for
a.
• An honest assessment of the challenges with your organization's current pro bono efforts that inhibit your ability to test, develop, and replicate innovations, and the reasons for them.
• At least three specific and important improvements to your organization's pro bono program that you would like to achieve in the first year of a two-year Transformation Grant.
b.
• The qualifications and relevant experience of each proposed team member.
• Whether a majority of your executive and senior managers agree that your organization's pro bono program needs significant improvements.
• The role your organization's executive director and/or senior managers would play in a pro bono transformation effort.
c.
• The estimated total cost and a clear description of what the grant will fund. Your narrative should provide a breakdown of the major expenses including, but not limited to, personnel, project expenses, contracts or sub-grants, etc., and how each expense supports the transformation effort to improve your pro bono program.
• For expenses related to personnel, please indicate how many and which positions will be fully or partially funded by the proposed grant.
• For contracts, please describe whether you intend to use consultants, implement new technology systems, conduct business process analysis, etc. and how this supports improvements to you pro bono program.
The LOI Narrative for
a.
• The impact of the Pro Bono Innovation Fund project to date, supported by data and analysis as to whether the goals of the project were achieved.
• Evidence of ongoing client need and how you intend to make the project part of your core legal services.
• The level of engagement of pro bono volunteers/private bar and the best practices in pro bono delivery that can be replicated by others.
• How ongoing program evaluation and data collection will be incorporated into the project.
b.
• The project staff that will be responsible for the sustainability phase of the project. Please include any additional staff, descriptions of new responsibilities for existing project staff and/or organizational changes that will be made.
• The role of your organization's executive management in the decision to seek this Sustainability Grant and recent examples of your organization's track record turning “new” or special projects into core legal services.
c.
• Estimated total project cost. This includes the estimate for the Pro Bono Innovation Fund requested amount and other in-kind or cash contributions to support the project. Your narrative should provide a breakdown of the major project expenses including, but not limited to, personnel, project expenses, etc., and how each expense supports the project design.
• A narrative proposing an ambitious match requirement that reduces the Pro Bono Innovation Fund contribution to the project for the grant term. LSC is not setting a specific percentage of required match for Sustainability Grant applicants, but will assess the two-year budget from the applicant's previously funded project with the grant amount proposed in the Sustainability LOI. LSC's expectation is that applicants will propose a meaningful shift from Pro Bono Innovation Fund support to other sources of support during the grant term.
• A narrative discussing the potential sources of funding that have been or will be cultivated. If the project has already received new financial support, please provide the source and amount committed and further describe the plans for ensuring continued financial support.
Cost Accounting Standards Board, Office of Federal Procurement Policy, Office of Management and Budget.
Notice of agenda for closed Cost Accounting Standards Board meetings.
The Office of Federal Procurement Policy (OFPP), Cost Accounting Standards Board (CAS Board) is publishing this notice to advise the public of planned meetings on November 27, 2018 and January 24, 2019. The notice is published pursuant to section 820(a) of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2017, which requires the CAS Board to publish agendas of its meetings in the
November 27, 2018 and January 24, 2019.
New Executive Office Building, 725 17th Street NW, Washington, DC 20503.
Raymond Wong, Staff Director, Cost Accounting Standards Board (telephone: 202-395-6805; email:
Section 820 amended section 1501(d) of title 41 of the United States Code to require that the CAS Board meet at least quarterly and publish a notice of its meetings, including the meeting agenda, in the
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2.
3.
4.
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
December 13, 2018; 8:00 a.m. to 12:00 p.m. (EST).
Welcome/Introductions; BFA/OIRM/OLPA/Budget Updates; Results from the 2018 Federal Employee Viewpoint Survey; Facilities Subcommittees Updates; CFO Office of the Future.
Renewing NSF; Renewing NSF—Partnerships Pillar; Meeting with Drs. Córdova and Crim; Committee Business/Wrap Up.
The National Science Board (NSB), pursuant to NSF regulations (45 CFR part 614), the National Science Foundation Act, as amended, (42 U.S.C. 1862n-5), and the Government in the Sunshine Act (5 U.S.C. 552b), hereby gives notice of the scheduling of meetings for the transaction of NSB business as follows:
Wednesday, November 28, 2018 from 8:00 a.m. to 5:00 p.m. and Thursday, November 29, 2018, from 8:15 a.m. to 1:45 p.m. EST.
These meetings will be held at the NSF headquarters, 2415 Eisenhower Avenue, Alexandria, VA 22314. Meetings are held in the boardroom on the 2nd floor. The public may observe public meetings held in the boardroom. All visitors must contact the Board Office (call 703-292-7000 or send an email to
Some of these meetings will be open to the public. Others will be closed to the public. See full description below.
The NSB Office contact is Brad Gutierrez,
Public meetings and public portions of meetings held in the 2nd floor boardroom will be webcast. To view these meetings, go to:
Please refer to the NSB website for additional information. You will find any updated meeting information and schedule updates (time, place, subject matter, or status of meeting) at
The NSB will continue its program to provide some flexibility around meeting times. After the first meeting of each day, actual meeting start and end times will be allowed to vary by no more than 15 minutes in either direction. As an example, if a 10:00 meeting finishes at 10:45, the meeting scheduled to begin at 11:00 may begin at 10:45 instead. Similarly, the 10:00 meeting may be allowed to run over by as much as 15 minutes if the Chair decides the extra time is warranted. The next meeting would start no later than 11:15. Arrive at the NSB boardroom or check the webcast 15 minutes before the scheduled start time of the meeting you wish to observe.
Pursuant to delegation by the Commission,
This proceeding involves an application from Interim Storage Partners LLC for a license to construct and operate a Consolidated Interim Storage Facility on its approximately 14,900-acre site in western Andrews County, Texas. In response to a notice published in the
The Board is comprised of the following Administrative Judges:
• Paul S. Ryerson, Chairman, Atomic Safety and Licensing Board Panel, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
• Nicholas G. Trikouros, Atomic Safety and Licensing Board Panel, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
• Dr. Gary S. Arnold, Atomic Safety and Licensing Board Panel, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
All correspondence, documents, and other materials shall be filed in accordance with the NRC E-Filing rule.
Weeks of November 26, December 3, 10, 17, 24, 31, 2018.
Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.
Public and Closed.
This meeting will be webcast live at the Web address—
This meeting will be webcast live at the Web address—
There are no meetings scheduled for the week of December 10, 2018.
There are no meetings scheduled for the week of December 17, 2018.
There are no meetings scheduled for the week of December 24, 2018.
There are no meetings scheduled for the week of December 31, 2018.
For more information or to verify the status of meetings, contact Denise McGovern at 301-415-0681 or via email at
The NRC Commission Meeting Schedule can be found on the internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (
Members of the public may request to receive this information electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555 (301-415-1969), or by email at
For the Nuclear Regulatory Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing recent Postal Service filings for the Commission's consideration concerning negotiated service agreements. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the market dominant or the competitive product list, or the modification of an existing product currently appearing on the market dominant or the competitive product list.
Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.
The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern market dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3010, and 39 CFR part 3020, subpart B. For request(s) that the Postal Service states concern competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comment deadline(s) for each request appear in section II.
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This Notice will be published in the
Postal Service
Notice.
The Postal Service hereby provides notice that it has filed a request with the Postal Regulatory Commission to transfer Inbound Letter Post small packets and bulky letters, and inbound registered service associated with such items, from the market-dominant product list to the competitive product list.
Anthony F. Alverno, 202-268-2997.
On November 16, 2018, the United States Postal Service® filed with the Postal Regulatory Commission the United States Postal Service Request to Transfer Inbound Letter Post Small Packets and Bulky Letters, and Inbound Registered Service Associated with Such Items, to the Competitive Product List, pursuant to 39 U.S.C. 3642. Documents pertinent to this request are available at
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 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 16, 2018, 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 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 16, 2018, 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 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 16, 2018, 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 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 16, 2018, it filed with the Postal Regulatory Commission a
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The proposed rule change consists of modifications to NSCC's Rules & Procedures (“Rules”) in order to reflect proposed enhancements to NSCC's Mutual Fund Services.
In its filing with the Commission, the clearing agency 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 clearing agency has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The proposed rule change consists of modifications to the Rules in order to reflect proposed enhancements to NSCC's Mutual Fund Services. The proposed rule change would enhance MFPS to provide for the delivery and receipt of event notifications relating to funds and pooled investment entities through a new feature called MF Info Xchange, as described in greater detail below.
In 1996, NSCC launched MFPS, providing participating Members with an automated method of transmitting and receiving daily price and rate information pertaining to funds and other pooled investment entities (collectively referred hereto as “Funds”) through a centralized and standardized facility.
MF Info Xchange would be a new feature of MFPS that would facilitate communication of event notifications among Funds, their principal underwriters or other entities authorized to process transactions on behalf of Funds, that are Members, Mutual Fund/Insurance Services Members, Investment Manager/Agent Members, TPP Members, TPA Members, Data Services Only Members and Fund Members (“data providers”), on the one hand, and the distribution partners of the Funds, such as broker-dealers and banks that are NSCC Members
The mutual fund industry has requested that NSCC deliver a data sharing solution for participants in the Fund industry to exchange such event notifications, and create standardization to the event notification process. The current event notification process is inconsistent among data providers and data receivers, with data providers sending event notifications using various methods without standardized formats across the industry. The existing methods of sending event notifications are often time consuming manual processes that add risk and complexity by increasing the chance of manual errors and leaving event notifications open to interpretation because of the lack of standardized formats. MF Info Xchange has been developed with the active participation of an industry working group to streamline the delivery and receipt of various types of Fund event notifications to provide a standardized method of sending event notifications.
Data providers using MF Info Xchange would be able to submit event notifications for distribution, using data entry, uploads and other input mechanisms, modify previously submitted event notifications, view upcoming and past notifications and manage distribution lists. Upon receipt of the event notification data through MF Info Xchange, NSCC would create a unique ID associated with the event relating to the notification, and track corrections and updates to the same event using the same event ID. NSCC would also store the data in a data repository for retrieval by NSCC Members. In addition, NSCC would distribute the event notifications via email to a defined distribution list provided by the data providers. Data providers could also indicate the NSCC Members on the distribution list that could be given access to the event notifications on the data repository. Such NSCC Members that have subscribed to MF Info Xchange would have access to the data repository to retrieve the event notifications and
NSCC Members would be able to use MF Info Xchange to transmit event notifications for certain predefined event types. Upon the initial launch, Fund mergers/acquisitions and Fund closures would be the only event types for which event notifications could be sent using MF Info Xchange. NSCC would announce by Important Notice posted on its website any enhancements of MF Info Xchange that result in new event types available for event notifications. Given the limited number of Fund event types available for event notifications upon the launch of MF Info Xchange, NSCC would not charge fees initially for the use of MF Info Xchange. NSCC would file with the Commission an appropriate rule change proposal to implement any fees for MF Info Xchange if NSCC adds a fee for the feature.
The proposed rule change would amend Rule 52 to state that NSCC would provide MF Info Xchange to enable data providers that are Members, Mutual Fund/Insurance Services Members, Investment Manager/Agent Members, TPP Members, TPA Members, Data Services Only Members and Fund Members to transmit event notifications relating to Funds to other NSCC Members and to other third parties identified by the data providers to receive the event notifications, or to otherwise supply and provide access to event notifications directly to or from NSCC through a data repository. The proposed rule change would provide that NSCC may determine from time to time, and would announce by Important Notice, which types of event notifications may be transmitted using MF Info Xchange. The proposed rule change would provide that NSCC would not be responsible for the completeness or accuracy of any event notifications transmitted using MF Info Xchange nor for any errors, omissions or delays that may occur relating to the event notifications.
NSCC expects to implement MF Info Xchange on November 29, 2018. As proposed, a legend would be added to Rule 52 stating there are changes that became effective upon filing with the Commission but have not yet been implemented. The proposed legend also would include a date on which such changes would be implemented and the file number of this proposal, and state that, once this proposal is implemented, the legend would automatically be removed from Rule 52.
Section 17A(b)(3)(F) of the Act
In addition, the proposed rule change is designed to be consistent with Rule 17Ad-22(e)(21) promulgated under the Act.
NSCC does not believe that the proposed rule change would have any adverse impact, or impose any burden, on competition because the proposed rule change would add an optional feature to NSCC's services that would provide data providers the ability to send event notification data in a standardized format. As an optional feature available for subscription with no additional fees, the proposed rule change would not disproportionally impact any NSCC participants.
Moreover, because the proposed rule change would allow data providers to more effectively communicate Fund event notifications, NSCC believes the proposed rule change would have a positive effect on competition among Fund industry participants. The proposed feature would provide data providers with a more efficient method of distributing event notifications to parties that need to see such information in order to facilitate the trading and processing of Fund securities. NSCC believes this would enhance competition among Funds and Fund participants by allowing parties to distribute such information more quickly and in a more streamlined manner.
NSCC has not received or solicited any written comments relating to this proposal. NSCC will notify the Commission of any written comments received by NSCC.
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 Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend BOX Rule 5070 (Long-term Options Contracts) to permit up to ten (10) expiration months for long-term options on SPY. The text of the proposed rule change is available from the principal office of the Exchange, at the Commission's Public Reference Room and also on the Exchange's internet website at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The self-regulatory organization 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 BOX Rule 5070 (Long-term Options Contracts) to permit up to ten (10) long-term options (“LEAPS”) expiration months for options on SPY.
The SPY options market today is characterized by its tremendous daily and annual liquidity. As a consequence, the Exchange believes that the listing of additional SPY LEAPS expiration months would be well received by investors. This proposal to expand the number of permitted SPY long-term expiration months would not apply to LEAPS on any other class of stock or Exchange-Traded Fund Shares.
Finally, BOX Rule 5070(a) currently states that there may be “up to six (6) additional expiration months.” Because the rule does not specify which expiration months the six months are in addition to, and thus is ambiguous, the Exchange proposes to delete the word “additional.” As amended, the rule would clearly and simply provide that the Exchange may list six expiration months having from twelve (12) to one
The Exchange believes that the proposal is consistent with the requirements of Section 6(b) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange believes that additional expiration months for SPY LEAPS does not represent a proliferation of expiration months, but is instead a very modest expansion of LEAPS options. Significantly, the proposal would feature new LEAPS expiration months in only a single class of options that are very liquid and heavily traded, as discussed above. Additionally, the Exchange notes by way of precedent that ten expiration months are already permitted for index LEAPS options. Further, the Exchange has the necessary systems capacity to support the new SPY expiration months.
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 proposal merely provides investors additional investment and risk management opportunities by providing flexibility to the Exchange to list additional long term options expiration series, expanding the number of SPY LEAPS offered on the Exchange from six expiration months to ten expiration months. As indicated above, the Exchange notes that this filing is based on a proposal recently submitted by Phlx.
The Exchange has neither solicited nor received comments on the proposed rule change.
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) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to 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 (“PRA”) (44 U.S.C. 3501
The collections of information required under Rules 400 through 404 is mandatory for all funding portals. Form Funding Portal helps ensure that the Commission can make information about funding portals transparent and easily accessible to the investing public, including issuers and obligated persons who engage funding portals; investors who may purchase securities through offerings on funding portals; and other regulators. Further, the information provided on Form Funding Portal expands the amount of publicly available information about funding portals, including disciplinary history. Consequently, the rules and forms allows issuers and the investing public, as well as others, to become more fully informed about funding portals in a more efficient manner.
Rule 400 requires each person applying for registration with the Commission as a funding portal to file electronically with the Commission Form Funding Portal. Rule 400(a) requires a funding portal to become a member of a national securities association registered under Section 15A of the Exchange Act. Rule 400(b) requires a funding portal to file an amendment to Form Funding Portal if any information previously submitted on Form Funding Portal becomes inaccurate for any reason. Rule 400(c) provides that a funding portal can succeed to the business of a predecessor funding portal upon the successor filing a registration on Form Funding Portal and the predecessor filing a withdrawal on Form Funding Portal.
Rule 400(d) requires a funding portal to promptly file a withdrawal of registration on Form Funding Portal upon ceasing to operate as a funding portal. Rule 400(e) states that duplicate originals of the applications and reports provided for in this section must be filed with surveillance personnel designated by any registered national securities association of which the funding portal is a member. Rule 400(f) requires a nonresident funding portal to: (1) Obtain a written consent and power of attorney appointing an agent for service of process in the United States; (2) furnish the Commission with the name and address of its agent for services of process on Schedule C of Form Funding Portal; (3) certify that it can, as a matter of law, and will provide the Commission and any registered national securities association of which it becomes a member with prompt access to its books and records and can, as a matter of law, and will submit to onsite inspection and examination by the Commission and any registered national securities association of which it becomes a member; and (4) provide the Commission with an opinion of counsel and certify on Schedule C on Form Funding Portal that the firm can, as a matter of law, provide the Commission and registered national securities association of which it becomes a member with prompt access to its books and records and can, as a matter of law, submit to onsite inspection and examination by the Commission and any registered national securities association of which it becomes a member.
Rule 403(a) requires a funding portal to implement written policies and procedures reasonably designed to achieve compliance with the federal securities laws and the rules and regulations thereunder relating to its business as a funding portal. Rule 403(b) provides that a funding portal must comply with privacy rules. Rule 404 requires all registered funding portals to maintain certain books and records relating to their funding portal activities, for not less than five years, the first two in an easily accessible place. Rule 404(e) requires funding portals to furnish promptly to the Commission, its representatives, and the registered national securities association of which the funding portal is a member true, correct, complete and current copies of such records of the funding portal that are requested by the representatives of the Commission and the registered national securities association.
The Commission staff estimates that annualized industry burden would be 17,554.35 hours to comply with Rules 400-404. The Commission staff estimates that the costs associated with complying with Rules 400-404 are estimated to be approximately a total amount of $308,729.
Written comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's estimates of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
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.
Please direct your written comments to: Charles Riddle, Acting Director/Chief Information Officer, Securities and
This matter comes before the Securities and Exchange Commission (“Commission”) on petition to review the temporary suspension and institution of proceedings, through delegated authority, of the BOX Exchange LLC (f/k/a BOX Options Exchange LLC) (the “Exchange”) proposed rule change to amend the fee schedule on the BOX Market LLC (“BOX”) options facility to establish certain connectivity fees and reclassify its high speed vendor feed connection as a port fee.
On July 27, 2018, the Commission issued a notice of filing of the proposed rule change filed with the Commission pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Exchange Act”)
On September 19, 2018, pursuant to Rule 430 of the Commission Rules of Practice,
Pursuant to Rule 431 of the Commission Rules of Practice,
Further, the Commission finds that it is in the public interest to lift the stay during the pendency of the Commission's review. The Commission believes the continued suspension of the proposed rule change while the Commission conducts proceedings to consider the Exchange's proposal will allow the Commission to further consider the proposed fees' consistency with the Exchange Act without the risk of allowing a fee that is potentially inconsistent with the Exchange Act to remain in effect. The Commission also does not believe that lifting the stay precludes meaningful review of the Order Instituting Proceedings.
For the reasons stated above, it is hereby:
Ordered that the Exchange's petition for review of the Division's action, by delegated authority, to temporarily suspend the proposed rule change and simultaneously institute proceedings to determine whether to approve or disapprove the proposed rule change be granted; and
It is further ordered that any party or other person may file a statement in support of or in opposition to the action made pursuant to delegated authority on or before December 10, 2018; and
It is further ordered that the automatic stay of delegated action pursuant to Commission Rule of Practice 431(e)
The order temporarily suspending such proposed rule change and instituting proceedings to determine whether to approve or disapprove such proposed rule change shall remain in effect.
By the Commission.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The Investment Company Act of 1940 (“Investment Company Act”) (15 U.S.C. 80a-1
Based on recent filings of notifications of registration on Form N-8A, we estimate that about 96 investment companies file such notifications each year. An investment company must only file a notification of registration on Form N-8A once. The currently approved average hour burden per investment company of preparing and filing a notification of registration on Form N-8A is one hour. Based on the Commission staff's experience with the requirements of Form N-8A and with disclosure documents generally—and considering that investment companies that are filing notifications of registration on Form N-8A simultaneously with the registration statement under the Investment Company Act are only required by Form N-8A to file a signed cover page—we continue to believe that this estimate is appropriate. Therefore, we estimate that the total annual hour burden to prepare and file notifications of registration on Form N-8A is 96 hours. The currently approved cost burden of Form N-8A is $449. We continue to believe that this estimate is appropriate. Therefore, we estimate that the total annual cost burden to associated with preparing and filing notifications of registration on Form N-8A is about $43,104.
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-8A 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 website,
On September 18, 2018, Nasdaq PHLX LLC (“Phlx” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The “Snapshot” functionality of the FBMS allows a Floor Broker, Registered Options Trader (“ROT”), or Specialist to “provisionally execute”
Currently, the “Snapshot” feature of the FBMS may only be used to provisionally execute certain types of orders in the trading crowd. Specifically, Floor Brokers, Specialists, and ROTS may only use Snapshot to provisionally execute multi-leg orders and simple orders in options on Exchange Traded Funds (“ETFs”) that are included in the Options Penny Pilot.
The Exchange represents that it does not anticipate that the use of Snapshot to provisionally execute
Finally, the Exchange notes that it expects to make Snapshot available for all orders before the end of the fourth quarter of 2018 and represents that it will notify its members via an Options Trader Alert, to be posted on the Exchange's website, at least seven calendar days prior to the date when Snapshot will be available for expanded use.
After careful review, the Commission finds that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange.
The Commission notes that use of the Snapshot functionality for certain orders is one of the current exceptions set forth in Phlx Rule 1000(f), and allows Floor Brokers, ROTS, and Specialists to provisionally execute, in the options trading crowd (as opposed to through FBMS), multi-leg orders and simple orders in options on ETFs that are included in the Options Penny Pilot.
Further, the Exchange represents that the proposal is consistent with Rule 611 of Regulation NMS, which requires the Exchange to establish policies and procedures that are reasonably designed to prevent trade-throughs of protected quotations. The Exchange notes that although the proposal will change the time of execution of a trade for purposes of verifying compliance with trade-though and priority rules, the current automated compliance verification process will continue to apply and will systematically prevent any violation of the trade-though and priority rules.
The Commission notes that, at the time Snapshot was adopted, the Exchange adopted several measures to help ensure that Snapshot operates, and is used by members, in a manner that is consistent with the Act and Phlx's rules.
For the foregoing reasons, the Commission finds that the proposed rule change is consistent with Section 6(b)(5) 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-5 (17 CFR 239.24 and 274.5) is the form used by small business investment companies (“SBICs”) to register their securities under the Securities Act of 1933 (15 U.S.C. 77a
The Commission did not receive any filings on Form N-5 in the last three years (and in the three years before that, received only one Form N-5 filing). Nevertheless, for purposes of this PRA, we conservatively estimate that at least one Form N-5 will be filed in the next three years, which translates to about 0.333 filings on Form N-5 per year. The currently approved internal burden of Form N-5 is 352 hours per response. We continue to believe this estimate for Form N-5's internal hour burden is appropriate. Therefore, the number of currently approved aggregate burden hours, when calculated using the current estimate for number of filings, is about 117 internal hours per year. The currently approved external cost burden of Form N-5 is $30,000 per filing. We continue to believe this estimate for Form N-5's cost burden is appropriate. Therefore, we estimate that the aggregate cost burden, when calculated using the Commission's estimate of 0.333 filings per year, is about $10,000 in external costs per year.
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-5 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.
Written comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information has practical utility; (b) the accuracy of the Commission's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
Please direct your written comments to Charles Riddle, Acting Director/Chief Information Officer, Securities and Exchange Commission, C/O Candace Kenner, 100 F Street NE, Washington, DC 20549; or send an email to:
Pursuant to the provisions of Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange is filing a proposal to amend Exchange Rule 518, Complex Orders [sic]
The text of the proposed rule change is available on the Exchange's website 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 Exchange Rule 518, Complex Orders, to (i) adopt a new Simple Market Auction or Timer (“SMAT”) Event (defined below); (ii) amend the Response Time Interval and Defined Time Period for Complex Auctions (each defined below); (iii) adopt a new Complex Liquidity Exposure Process (“cLEP”); (iv) make minor changes to the Complex MIAX Options Price Collar Protection; and (v) clarify that the Calendar Spread Variance (“CSV”) price protection applies only to strategies in American-style option
Specifically, the Exchange proposes to amend subsection (a)(16), to adopt a new Simple Market Auction or Timer (SMAT) Event. A SMAT Event is
Additionally, the Exchange proposes to amend subsection (d)(3) which describes the Response Time Interval of a Complex Auction, which is a single-sided auction. The Exchange offers Complex Auction functionality as described in Exchange Rule 518
Currently, Rule 518(d)(3) provides that the Response Time Interval means the period of time during which responses to the Request for Responses (“RFR”) message may be entered. The Rule further provides that the Exchange determines the duration of the Response Time Interval, which shall not exceed 500 milliseconds, and communicates it to Members via Regulatory Circular.
The Exchange also proposes to adopt new subsection (e) to describe a Complex Liquidity Exposure Process (“cLEP”) for complex orders and complex eQuotes that would violate their Complex MIAX Price Collar (“MPC”) price . The MPC price protection feature is an Exchange-wide mechanism under which a complex order or complex eQuote to sell will not be displayed or executed at a price that is lower than the opposite side cNBBO
The Exchange now proposes to initiate a Complex Liquidity Exposure Auction (“cLEP Auction”) whenever a complex order or complex eQuote would violate its MPC Price. To begin the cLEP Auction, the System will first broadcast a liquidity exposure message to all subscribers of the Exchange's data feeds. The liquidity exposure message will include the symbol, side of the market, auction start price (MPC Price), quantity of matched contracts, and the imbalance quantity. The inclusion of the quantity of matched contracts at the price included in the RFR message is intended to inform participants considering submitting an RFR Response the number of contracts for which there is matched interest, and the purposes of including the imbalance quantity in the RFR message is to inform such participants of the number of contracts that do not have matched interest.
The System will initiate a Response Time Interval, as determined by the Exchange and communicated via Regulatory Circular which shall be no less than 100 milliseconds and no more than 5,000 milliseconds.
At the conclusion of a cLEP Auction the System will calculate the next potential MPC Price using the auction start price plus (minus) the next MPC increment for buy (sell) orders. Liquidity with an original price equal to or less aggressive than the new MPC Price is no longer subject to the MPC price protection. Liquidity with an original price more aggressive than the new MPC Price (or market order liquidity) is subject to the MPC price protection feature using the new MPC Price.
The current rule provides that if the MPC Price is priced less aggressively than the limit price of the complex order or eQuote (
The Exchange now proposes to amend subsection(f)(6)(A) to provide that any unexecuted portion of such a complex order or eQuote will be subject to the cLEP as described in proposed subsection (e). The Exchange believes it to be in the best interest of the Member to seek liquidity via the Complex Liquidity Exposure Process as described above, rather than cancel any unexecuted portion of the order.
The examples below demonstrate an order subject to the Complex Liquidity Exposure Process.
The Exchange has one order resting on its Strategy Book:
The Exchange receives a new order (Order 2) to buy 20 at $2.25.
Order 2 buys 10 from Order 1 at $1.90 and initiates the Complex Liquidity Exposure Process: Order 2 reprices to its protected price of $2.10 (cNBO of 1.85 + 0.25) and is posted at that price on the Complex Order Book and the Complex Liquidity Exposure Process Timer begins.
During the cLEP Auction the Exchange receives a new order (Order 3) to sell 10 at $2.10. This order locks the current same side Book Price of $2.10 and Order 3 sells 10 to Order 2 at $2.10, filling Order 2 and ending the Liquidity Exposure Process.
The Exchange has one order resting on its book in Strategy +1 component A, −1 component B:
The Exchange receives a new order (Order 2) to buy 20 at $2.25.
Order 2 buys 10 from Order 1 at $1.90 and initiates the Complex Liquidity Exposure Process: Order 2 reprices to its protected price of $2.10 (cNBO of 1.85 + 0.25) and is posted at that price on the Strategy Book and the Complex Liquidity Exposure Process Timer begins.
No new liquidity arrives during the Liquidity Exposure Process. At the end of the timer, Order 2 reprices to its limit of $2.25 and is posted at that price on the Strategy Book, ending the Liquidity Exposure Process.
The Exchange also proposes to make minor technical changes to Interpretations and Policies .05 of Exchange Rule 518 to reflect the proposed changes described above. Specifically, the Exchange proposes to remove subparagraph (f)(4) that provides that once established, the MPC
Finally, the Exchange proposes to amend subsection (b) of Interpretations and Policies .05 to adopt new rule text stating that the Calendar Spread Variance (“CSV”) price protection applies only to strategies in American-style option classes. A Calendar Spread is a complex strategy consisting of the purchase of one call (put) option and the sale of another call (put) option overlying the same security that have different expirations but the same strike price. The CSV establishes a minimum trading price limit for Calendar Spreads. The maximum possible value of a Calendar Spread is unlimited, thus there is no maximum price protection for Calendar Spreads. The minimum possible trading price limit of a Calendar Spread is zero minus the pre-set value of $.10. This ensures that the Strategy doesn't trade more than $.10 away from its intrinsic value. (On a basic level the price of an American-style option is comprised of two components; intrinsic value and time value. If the strike price of a call option is $5.00 and the stock is priced at $6.00, there is $1.00 of intrinsic value in the price of the call option, anything above $1.00 represents the time value component.) An American-style option must be worth at least as much as its intrinsic value because the holder of the option can realize the intrinsic value by immediately exercising the option. In a Calendar Spread strategy comprised of American-style options, ceteris paribus, the far month should be worth more than the near month due to its having a greater time to expiration and therefore a higher time value. As European-style options
The Exchange believes that its proposed rule change is consistent with Section 6(b) of the Act
The Exchange believes its proposal to include the liquidity exposure timer as a SMAT Event promotes just and equitable principles of trade, removes impediments to and perfects the mechanisms of a free and open market and a national market system and, in general, protects investors and the public interest. SMAT Events represent temporary interruptions of free trading in one or more components of a complex strategy. The temporary suspension of trading in complex orders during a SMAT Event is intended to enhance continuity, trade-through protection, and orderliness in the simple market and to protect complex order components from being executed at prices that could improve following a SMAT Event. Once a SMAT Event is concluded or resolved, the System will re-evaluate the Strategy Book.
The Exchange believes that its proposal to eliminate the Defined Time Period to allow Complex Auctions
The Exchange also believes its proposal to adopt a Complex Liquidity Exposure Process promotes just and equitable principles of trade and removes impediments to and perfects the mechanisms of a free and open market and a national market system and, in general, protects investors and the public interest. The Complex Liquidity Exposure Process provides an additional opportunity for price discovery for those orders that would trade through their MPC Price. The Exchange believes its proposal promotes just and equitable principles of trade as it is in the best interest of the Member to seek liquidity for the unexecuted portion of the order which exceeds the order's MPC Price rather than to simply cancel the unexecuted portion back to the Member.
The Exchange also believes that its proposal to amend Interpretations and Policies .05(f) to reflect the changes resulting from the introduction of the Complex Liquidity Exposure Process promotes just and equitable principles of trade, and removes impediments to and perfects the mechanisms of a free and open market and a national market system and, in general, protects investors and the public interest by clearly describing the operation of the Exchange's functionality in the Exchange's rules. The Exchange believes it is in the interest of investors and the public to accurately describe the behavior of the Exchange's System in its
Finally, the Exchange believes its proposal to clarify that the Calendar Spread Variance (CSV) price protection is available only for American-style options promotes just and equitable principles of trade, and removes impediments to and perfects the mechanisms of a free and open market and a national market system and, in general, and protects investors and the public interest by providing clarity and precision in the Exchange's rules. The Exchange believes it is in the interest of investors and the public to accurately describe the behavior of the Exchange's System in its rules as this information may be used by investors to make decisions concerning the submission of their orders. Transparency and clarity are consistent with the Act because it removes impediments to and helps perfect the mechanism of a free and open market and a national market system, and, in general, protects investors and the public interest by accurately describing the behavior of the Exchange's System. In particular, the Exchange believes that the proposed rule change will provide greater clarity to Members and the public regarding the Exchange's Rules, and it is in the public interest for rules to be accurate and concise so as to eliminate the potential for confusion.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange does not believe the proposed rule change will impose any burden on inter-market competition. The Exchange's proposal seeks to enhance complex order trading on the Exchange, and may potentially enhance competition among the various markets for complex order execution, potentially resulting in more active complex order trading on all exchanges.
Additionally, the Exchange does not believe the proposed rule change will impose any burden on intra-market competition as the Rules apply equally to all Members of the Exchange.
Written comments were neither solicited nor received.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove the proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to 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
Form 8-A (17 CFR 249.208a) is a registration statement used to register a class of securities under Section 12(b) or Section 12(g) of the Securities Exchange Act of 1934 (15 U.S.C. 78
Written comments are invited on: (a) Whether this collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden imposed by 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.
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.
Please direct your written comment to Charles Riddle, Acting Director/Chief Information Officer, Securities and Exchange Commission, c/o Candace Kenner, 100 F Street NE, Washington, DC 20549 or send an email to:
60-Day notice and request for comments.
The Small Business Administration (SBA) intends to request approval, from the Office of Management and Budget (OMB) for the collection of information described below. The Paperwork Reduction Act (PRA) requires federal agencies to publish a notice in the
Submit comments on or before January 22, 2019.
Send all comments to Dena Moglia, Office of Entrepreneurial Development, Small Business Administration, 409 3rd Street SW, 6th Floor, Washington, DC 20416.
Dena Moglia, Senior Management & Program Analyst, 202-205-7034,
In accordance with regulations and policy, the Small Business Development Centers (SBDC's) must provide SBA semi-annual financial and programmatic reports-outlining expenditures and accomplishments. The information collected will be used to monitor the progress of the program.
60-Day notice and request for comments.
The Small Business Administration (SBA) intends to request approval, from the Office of Management and Budget (OMB) for the collection of information described below. The Paperwork Reduction Act (PRA) of 1995 requires federal agencies to publish a notice in the
Submit comments on or before January 22, 2019.
Send all comments to Michael Donadieu, Director, Office of Small Business Investment Companies Examinations, Small Business Administration, 409 3rd Street, 7th Floor, Washington, DC 20416.
Michael Donadieu, Director, Office of Small Business Investment Companies Examinations, 202-205-7281,
Form 857 is used by SBA examiners to obtain information about financing provided by small business investment companies (SBICs). This information, which is collected directly from the financed small business, provides independent confirmation of information reported to SBA by SBICs, as well as additional information not reported by SBICs.
60-Day notice and request for comments.
The Small Business Administration (SBA) intends to request approval, from the Office of Management and Budget (OMB) for the new collection of information described below. The Paperwork Reduction Act (PRA) requires federal agencies to
Submit comments on or before January 22, 2019.
Send all comments to Sharon Gurley, Director, Office of Business Development, Small Business Administration, 409 3rd Street, 8th Floor, Washington, DC 20416.
Sharon Gurley, Director, Office of Business Development,
In accordance with 13 CFR 124.604, as part of its annual review submission, each Participant owned by a Tribe, ANC, NHO or CDC must submit to SBA information showing how they have provided benefits to their members and communities. This data includes information relating to funded cultural programs, employment assistance, jobs, scholarships, internships, subsistence activities, and other services provided.
SBA is requesting comments on (a) whether the collection of information is necessary for the agency to properly perform its functions; (b) whether the burden estimates are accurate; (c) whether there are ways to minimize the burden, including through the use of automated techniques or other forms of information technology; and (d) whether there are ways to enhance the quality, utility, and clarity of the information.
60-Day notice and request for comments.
The Small Business Administration (SBA) intends to request approval, from the Office of Management and Budget (OMB) for the collection of information described below. The Paperwork Reduction Act (PRA) requires federal agencies to publish a notice in the
Submit comments on or before January 22, 2019.
Send all comments to Dena Moglia, Office of Entrepreneurial Development, Small Business Administration, 409 3rd Street, 6th Floor, Washington, DC 20416.
Dena Moglia, Senior Management & Program Analyst, 202-205-7034,
In October 2014, a new cohort of sites was added to the Regional Innovation Clusters (RIC) initiative, which was originally started in October 1, 2010 by the Small Business Administration (SBA)'s Office of Entrepreneurial Development. Through this initiative, organizations in 11 communities across the U.S. have been selected to provide industry-specific assistance to small businesses, and to develop industry relationships and supply chains within their regions. Clusters—geographically concentrated groups of interconnected businesses, suppliers, service providers, and associated institutions in a particular industry or field—act as a networking hub to convene a number of resources to help navigate the funding, procurement, and supply-chain opportunities in a specific industry.
SBA is conducting an evaluation of the Regional Innovation Clusters initiative to determine how the clusters have developed, the type and volume of services they provided to small businesses, client perceptions of the program, and the various outcomes related to their existence, including collaboration among firms, innovation, and small business growth. Small business growth will be compared to the overall growth of firms in those same regions and industries. This evaluation will also include lessons learned and success stories. SBA proposes the use of three instruments for data collection and analysis of three distinct populations. These instruments are: (1) Small Business Survey, (2) Large Organization Survey and (3) Cluster Administrator Survey. In addition, SBA plans to interview each of the 11 cluster administrators several times a year regarding program impact and successes or challenges, and to obtain clarifications on information provided in quarterly reports. Each of the proposed surveys will be administered electronically and will contain both open- and close-ended questions. The information collected and analyzed from these instruments will contribute to monitoring performance metrics and program goals, as well as recommendations on improving program practices.
60-Day notice and request for comments.
The Small Business Administration (SBA) intends to request approval, from the Office of Management and Budget (OMB) for the collection of information described below. The Paperwork Reduction Act (PRA) of 1995 requires federal agencies to publish a notice in the
Submit comments on or before January 22, 2019.
Send all comments to Mary Frias, Loan Specialist, Office of Financial Assistance, Small Business
Mary Frias, Loan Specialist, Office of Financial Assistance,
The servicing agent agreement is executed by the borrower, and the certified development company as the loan servicing agent. The agreement is primarily used by the certified development company as the loan servicing agent and acknowledges the imposition of various fees allowed in SBA's 504 loan program.
SBA is requesting comments on (a) Whether the collection of information is necessary for the agency to properly perform its functions; (b) whether the burden estimates are accurate; (c) whether there are ways to minimize the burden, including through the use of automated techniques or other forms of information technology; and (d) whether there are ways to enhance the quality, utility, and clarity of the information.
By virtue of the authority vested in me under section 7041(f)(3) of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2018 (Div. K, Pub. L. 115-141) (SFOAA) and Department of State Delegation of Authority 245-2, I hereby certify that all practicable steps have been taken to ensure that mechanisms are in place for monitoring, oversight, and control of funds made available by section 7041(f) of the SFOAA for assistance for Libya.
This certification shall be published in the
Tulsa-Sapulpa Union Railway Company, L.L.C. (TSU), a Class III rail carrier, has filed a verified notice of exemption under 49 CFR 1150.41 to renew its lease of approximately 12.86 miles of railroad line owned by Union Pacific Railroad Company (UP), located in Tulsa County, Okla. (the Line). The Line, known as the Jenks Industrial Lead, extends from milepost 136.40 near the Kimberly Clark facility in Jenks, Okla., to the end of UP's ownership at milepost 149.26 and the connection with UP's trackage rights over BNSF Railway Company in Tulsa, Okla.
TSU states that it and UP previously executed a lease agreement regarding the Line in 2001.
TSU certifies that its projected annual revenues from this transaction will not result in its becoming a Class I or Class II rail carrier and will not exceed $5 million. As required under 49 CFR 1150.43(h)(1), TSU has disclosed in its verified notice that the lease renewal agreement contains an interchange commitment that charges TSU an asset use fee for carloads that originate or terminate on the Line that are not interchanged to UP.
TSU states in its verified notice that it intends to consummate the proposed lease renewal on or shortly after December 21, 2018. The earliest this transaction may be consummated is December 7, 2018 (30 days after the verified notice was filed).
If the verified notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions to stay must be filed no later than November 30, 2018 (at least seven days before the exemption becomes effective).
An original and 10 copies of all pleadings, referring to Docket No. FD 36237, must be filed with the Surface Transportation Board, 395 E Street SW, Washington, DC 20423-0001. In addition, a copy of each pleading must be served on TSU's representative, Audrey L. Brodrick, Fletcher & Sippel LLC, 29 North Wacker Drive, Suite 800, Chicago, IL 60606-3208.
According to TSU, this action is categorically excluded from environmental review under 49 CFR 1105.6(c) and from historic reporting under 49 CFR 1105.8(b).
Board decisions and notices are available on our website at
By the Board, Scott M. Zimmerman, Acting Director, Office of Proceedings.
R.J. Corman Railroad Group, LLC (RJCG), a noncarrier holding company, and its wholly owned subsidiary, R.J. Corman Railroad Company, LLC (RJCR), have jointly filed a verified notice of exemption pursuant to 49 CFR 1180.2(d)(2) to acquire control of two Class III railroads, Nashville and Western Railroad Corp. (NWRR) and Nashville & Eastern Railroad Corp. (NERR). NWRR and NERR are currently controlled by William J. Drunsic.
RJCG and RJCR currently control 12 Class III railroads.
RJCG and RJCR have signed a Plan of Merger and Sale and Purchase of Equity Interests (Agreement)
The earliest the transaction could be consummated is December 9, 2018, the effective date of the exemption (30 days after the verified notice was filed). RJCG and RJCR state that the transaction is scheduled to be finalized during the first quarter of 2019.
RJCG and RJCR certify that: (i) NWRR and NERR do not connect with each other or any of the RJC Railroads; (ii) the proposed transaction is not part of a series of anticipated transactions that would connect some or all of these railroads; and (iii) the transaction does not involve a Class I carrier. Therefore, the transaction is exempt from the requirements of 49 U.S.C. 11323.
Under 49 U.S.C. 10502(g), the Board may not use its exemption authority to relieve a rail carrier of its statutory obligation to protect the interests of its employees. Section 11326(c), however, does not provide for the labor protection for transactions under sections 11324 and 11325 that involve only Class III rail carriers. Therefore, because this transaction involves only Class III rail carriers, the Board may not impose labor protective conditions for this transaction.
If the verified notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the transaction. Petitions to stay must be filed no later than November 30, 2018 (at least seven days before the exemption becomes effective).
An original and ten copies of all pleadings, referring to Docket No. FD 36250, must be filed with the Surface Transportation Board, 395 E Street SW, Washington, DC 20423-0001. In addition, a copy of each pleading must be served on David R. Irvin, Esq., Moynahan, Irvin & Mooney P.S.C., 110 N Main Street, Nicholasville, KY 40356.
Board decisions and notices are available on our website at
By the Board, Scott M. Zimmerman, Acting Director, Office of Proceedings.
Watco Holdings Inc. (Watco), a noncarrier, has filed a verified notice of exemption under 49 CFR 1180.2(d)(2) to continue in control of Ithaca Central Railroad, LLC (ICR), upon ICR's becoming a Class III rail carrier. Watco owns, indirectly, 100% of the issued and outstanding stock of ICR.
This transaction is related to a verified notice of exemption filed concurrently in
The transaction may be consummated on or after December 8, 2018, the effective date of the exemption (30 days after the verified notice of exemption was filed).
According to the verified notice of exemption, Watco currently controls indirectly 38 Class III railroads and one Class II railroad, collectively operating in 25 states. For a complete list of these rail carriers and the states in which they operate, see the November 8, 2018 verified notice of exemption at pages 4-11. The verified notice is available on the Board's website at
Watco represents that: (1) The rail line to be operated by ICR does not connect with any of the rail lines operated by railroads in the Watco corporate family; (2) this transaction is not part of a series of anticipated transactions that would connect ICR with any railroad in the Watco corporate family; and (3) the transaction does not involve a Class I rail carrier. The proposed transaction is therefore exempt from the prior approval requirements of 49 U.S.C. 11323 pursuant to 49 CFR 1180.2(d)(2). Watco states that the purpose of the transaction is to reduce overhead expenses and coordinate billing, maintenance, mechanical and personnel policies and procedures of its rail carrier subsidiaries, and thereby improve the overall efficiency of rail service provided by the railroads in the Watco corporate family.
Under 49 U.S.C. 10502(g), the Board may not use its exemption authority to relieve a rail carrier of its statutory obligation to protect the interests of its employees. Because the transaction involves the control of one Class II and one or more Class III rail carriers, the transaction is subject to the labor protection requirements of 49 U.S.C. 11326(b) and
If the verified notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions for stay must be filed no later than November 30, 2018 (at least seven days before the exemption becomes effective).
An original and 10 copies of all pleadings, referring to Docket No. FD 36243, must be filed with the Surface Transportation Board, 395 E Street SW, Washington, DC 20423-0001. In addition, one copy of each pleading must be served on Karl Morell & Associates, 440 1st Street NW, Suite 440, Washington, DC 20001.
According to Watco, this action is categorically excluded from environmental review under 49 CFR 1105.6(c).
Board decisions and notices are available on our website at
By the Board, Scott M. Zimmerman, Acting Director, Office of Proceedings.
Ithaca Central Railroad LLC (ICR), a noncarrier, has filed a verified notice of exemption under 49 CFR 1150.31 to lease from Norfolk Southern Railway Company (NSR) and operate approximately 48.8 miles of rail line, extending from milepost 272.2 in Sayre, Pa., to milepost 321.0 in Lansing, N.Y.
This transaction is related to a concurrently filed verified notice of exemption in
ICR states that it will shortly enter into an agreement to lease the rail line from NSR and that ICR will be the operator of the leased line. ICR further states that the proposed agreement between ICR and NSR does not contain any provision that prohibits ICR from interchanging traffic with a third party or limits ICR's ability to do so.
ICR certifies that its projected annual revenues as a result of this transaction will not result in ICR's becoming a Class II or Class I rail carrier. ICR further certifies that the projected annual revenue of ICR will not exceed $5 million.
The transaction may be consummated on or after December 8, 2018, the effective date of the exemption (30 days after the verified notice was filed).
If the verified notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions for stay must be filed no later than November 30, 2018 (at least seven days before the exemption becomes effective).
An original and 10 copies of all pleadings, referring to Docket No. FD 36238, must be filed with the Surface Transportation Board, 395 E Street SW, Washington, DC 20423-0001. In addition, one copy of each pleading must be served on Karl Morell & Associates, 440 1st Street NW, Suite 440, Washington, DC 20001.
According to ICR, this action is excluded from environmental review under 49 CFR 1105.6(c) and from historic reporting requirements under 49 CFR 1105.8(b).
Board decisions and notices are available on our website at
By the Board, Scott M. Zimmerman, Acting Director, Office of Proceedings.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of renewal of exemptions; request for comments.
FMCSA announces its decision to renew exemptions for five individuals from the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that interstate commercial motor vehicle (CMV) drivers have “no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.” The exemptions enable these individuals who have had one or more seizures and are taking anti-seizure medication to continue to operate CMVs in interstate commerce.
Each group of renewed exemptions were applicable on the dates stated in the discussions below and will expire on the dates stated in the discussions below. Comments must be received on or before December 24, 2018.
You may submit comments identified by the Federal Docket Management System (FDMS) Docket Nos. FMCSA-2014-0214; FMCSA-2014-0215 using any of the following methods:
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Ms. Christine A. Hydock, Chief, Medical Programs Division, 202-366-4001,
If you submit a comment, please include the docket numbers for this notice (Docket Nos. FMCSA-2014-0214; FMCSA-2014-0215), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.
To submit your comment online, go to
If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
FMCSA will consider all comments and material received during the comment period.
To view comments, as well as any documents mentioned in this notice as being available in the docket, go to
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption for up to five years if it 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. The statute also allows the Agency to renew exemptions at the end of the five-year period. FMCSA grants exemptions from the FMCSRs for a two-year period to align with the maximum duration of a driver's medical certification.
The physical qualification standard for drivers regarding epilepsy found in 49 CFR 391.41(b)(8) states that a person is physically qualified to drive a CMV if that person has no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause the loss of consciousness or any loss of ability to control a CMV.
In addition to the regulations, FMCSA has published advisory criteria to assist Medical Examiners in determining whether drivers with certain medical conditions are qualified to operate a CMV in interstate commerce. [49 CFR part 391, APPENDIX A TO PART 391—MEDICAL ADVISORY CRITERIA, section H. Epilepsy: § 391.41(b)(8), paragraphs 3, 4, and 5.]
The five individuals listed in this notice have requested renewal of their exemptions from the epilepsy and seizure disorders prohibition in 49 CFR 391.41(b)(8), in accordance with FMCSA procedures. Accordingly, FMCSA has evaluated these applications for renewal on their merits and decided to extend each exemption for a renewable two-year period.
Interested parties or organizations possessing information that would otherwise show that any, or all, of these drivers are not currently achieving the statutory level of safety should immediately notify FMCSA. The Agency will evaluate any adverse evidence submitted and, 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, FMCSA will take immediate steps to revoke the exemption of a driver.
In accordance with 49 U.S.C. 31136(e) and 31315, each of the five applicants has satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition. The five drivers in this notice remain in good standing with the Agency, have maintained their medical monitoring and have not exhibited any medical issues that would compromise their ability to safely operate a CMV during the previous two-year exemption period. In addition, for Commercial Driver's License (CDL) holders, the Commercial Driver's License Information System (CDLIS) and the Motor Carrier Management Information System (MCMIS) are searched for crash and violation data. For non-CDL holders, the Agency reviews the driving records from the State Driver's Licensing Agency (SDLA). These factors provide an adequate basis for predicting each driver's ability to continue to safely operate a CMV in interstate commerce. Therefore, FMCSA concludes that extending the exemption for each renewal applicant for a period of two years is likely to achieve a level of safety equal to that existing without the exemption.
As of October 24, 2018, and in accordance with 49 U.S.C. 31136(e) and 31315, the following individual has satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition in the FMCSRs for interstate CMV drivers: Jeffrey M. Phillips (SC).
This driver was included in docket number FMCSA-2014-0214. The exemption is applicable as of October 24, 2018, and will expire on October 24, 2020.
As of October 15, 2018, and in accordance with 49 U.S.C. 31136(e) and 31315, the following four individuals have satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition in the FMCSRs for interstate CMV drivers:
The drivers were included in docket number FMCSA-2014-0215. Their exemptions are applicable as of October 15, 2018, and will expire on October 15, 2020.
The exemptions are extended subject to the following conditions: (1) Each driver must remain seizure-free and maintain a stable treatment during the two-year exemption period; (2) each driver must submit annual reports from their treating physicians attesting to the stability of treatment and that the driver has remained seizure-free; (3) each driver must undergo an annual medical examination by a certified Medical Examiner, as defined by 49 CFR 390.5; and (4) each driver must provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keep a copy of his/her driver's qualification file if he/she is self-employed. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official. The exemption will be rescinded if: (1) The person fails 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.
During the period the exemption is in effect, no State shall enforce any law or
Based on its evaluation of the five exemption applications, FMCSA renews the exemptions of the aforementioned drivers from the epilepsy and seizure disorders prohibition in 49 CFR 391.41(b)(8). In accordance with 49 U.S.C. 31136(e) and 31315, each exemption will be valid for two years unless revoked earlier by FMCSA.
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, PHMSA invites comments on this information collection pertaining to hazardous materials transportation for which PHMSA intends to request renewal from the Office of Management and Budget.
Interested persons are invited to submit comments on or before January 22, 2019.
You may submit comments identified by the Docket No. PHMSA-2018-0102 (Notice No. 2018-19) by any of the following methods:
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Requests for a copy of an information collection should be directed to Steven Andrews or Shelby Geller, Standards and Rulemaking Division, (202) 366-8553, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590-0001.
Steven Andrews or Shelby Geller, Standards and Rulemaking Division, (202) 366-8553, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590-0001.
Section 1320.8 (d), title 5, Code of Federal Regulations (CFR) requires PHMSA to provide interested members of the public and affected agencies an opportunity to comment on information collection and recordkeeping requests. This notice identifies information collection request that PHMSA will be submitting to the Office of Management and Budget (OMB) for renewal and extension. This information collection is contained in 49 CFR 171.6 of the Hazardous Materials Regulations (HMR; 49 CFR parts 171-180). PHMSA has revised burden estimates, where appropriate, to reflect current reporting levels or adjustments based on changes in proposed or final rules published since this information collection was last approved. The following is provided for this information collection: (1) Title of the information collection, including former title if a change is being made; (2) OMB control number; (3) summary of the information collection activity; (4) description of affected public; (5) estimate of total annual reporting and recordkeeping burden; and (6) frequency of collection. PHMSA will request a 3-year term of approval for this information collection activity and will publish a notice in the
PHMSA requests comments on the following information collection:
Office of the Secretary (“OST”), Department of Transportation (“DOT”).
Notice of reestablishment and first meeting of the Aviation Consumer Protection Advisory Committee.
The Department of Transportation (“Department”) has reestablished the Aviation Consumer Protection Advisory Committee (“ACPAC” or “Committee”), formerly known as the Advisory Committee on Aviation Consumer Protection, as a Federal advisory committee. The Department has also established a National In-Flight Sexual Misconduct Task Force (“Task Force”) as an ACPAC Subcommittee. The Task Force will develop recommendations for the ACPAC's consideration on best practices and protocols for air carriers relating to training, reporting, and data collection of sexual assault onboard commercial aircraft. The Department anticipates the first meeting of the ACPAC will be held on January 16, 2019. The meeting will be held in the Media Center (located on the lobby level of the West Building) at the U.S. Department of Transportation Headquarters,1200 New Jersey Ave, SE, Washington, DC 20590. Three topics will be discussed at that meeting—(1) establishment of the Task Force (including the tasks to be carried out by the Task Force); (2) transparency of airline ancillary service fees; and (3) involuntary changes to travel itineraries.
The first meeting of the reestablished ACPAC will be held on January 16, 2019, from 9:00 a.m. to 4:00 p.m. Eastern Time.
To register to attend the meeting, please contact Stuart Hindman, Senior Attorney, Office of Aviation Enforcement and Proceedings, by email at
On May 24, 2012, the Department established an advisory committee on aviation consumer protection, known as the Advisory Committee on Aviation Consumer Protection, as mandated by section 411 of the FAA Modernization and Reform Act of 2012 (Pub. L. 112-95, 126 Stat. 11 (2012)) (2012 FAA Act) and the Federal Advisory Committee Act (FACA), as amended. The original Committee held nine meetings and examined a broad range of issues affecting consumers. The Committee has contributed significantly to the Department's aviation consumer protection program as it provides a forum for stakeholders, including representatives of airlines, airports and consumers, to discuss important consumer issues.
The statutory termination date for the Committee was originally established by the 2012 FAA Act as September 30, 2015, but has been extended several times, most recently by the FAA Reauthorization Act of 2018 (Pub. L. No: 115-254) (2018 FAA Act) to the current termination date of September 30, 2023.
The Department has updated the Committee's charter to clarify that the Committee's work should concern aviation consumer protection issues that fall within the current statutory authority of the Department and establish a subcommittee to be called the “National In-Flight Sexual Misconduct Task Force.”
The Secretary has appointed four new members to the Committee. The appointed members are: (1) Patricia Vercelli, General Counsel, Airlines for America, as the airline representative; (2) Mario Rodriguez, Executive Director of the Indianapolis Airport Authority, as the airport operator representative; (3) Pete K. Rahn, Maryland Secretary of Transportation, as the State or local government representative; and (4) Frances Smith, Adjunct Fellow, Competitive Enterprise Institute, as the consumer representative. Mr. Rahn will serve as the Chair of the Committee. The Department chose the Committee members based on two main criteria: (1) Representativeness (does the individual represent one of the four groups mentioned above); and (2) expertise (does the individual bring essential knowledge, expertise, or experience regarding consumer protection).
Recent reports of increased incidents of sexual assault and misconduct onboard aircraft have highlighted concerns regarding the response to such incidents. The Joint Explanatory Statement of the 2018 Consolidated Appropriations Act requested that the Department establish a Task Force to provide recommendations in this area. In addition, the Task Force is mandated by the 2018 FAA Act. Accordingly, a Task Force has been established as a subcommittee under the ACPAC to consider best practices and protocols for air carriers relating to training, reporting, and data collection of sexual misconduct by passengers onboard commercial aircraft. The Task Force will include representatives from the Department of Transportation, Department of Justice (including the Federal Bureau of Investigations, Office of Victims of Crime and Office on Violence Against Women), Department of Health and Human Services, national organizations which specialize in providing services to sexual assault
The first meeting of the reestablished ACPAC will take place at the Department's headquarters in Washington, DC on January 16, 2019. During the first meeting, the Department will announce the members of the Task Force and there will be a discussion of the duties of the Task Force members. In addition, two other topics—the transparency of airline ancillary service fees and involuntary changes to itineraries—will be discussed. The Joint Explanatory Statement of the 2018 Consolidated Appropriations Act requests that the Department work in collaboration with industry, consumers and other stakeholders to establish guidelines on transparency of airline ancillary fees. In addition, the 2018 FAA Act mandates that the Department review and make recommendations with regard to air carriers' handling of involuntary changes to passengers' travel itineraries, and that the Department may consult with the Committee for this purpose. Accordingly, the Committee will discuss these issues during the meeting.
The Department's Office of Aviation Enforcement and Proceedings, within the Office of the General Counsel, will provide appropriate funding, logistics, administrative, and technical support for the Committee. The Department's subject matter experts will also provide support to the Committee.
You may view any documents mentioned in this preamble as being available in the docket at
Office of Foreign Assets Control, Treasury.
Notice.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of this person are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
See
The Specially Designated Nationals and Blocked Persons List and additional information concerning OFAC sanctions programs are available on OFAC's website (
On November 19, 2018, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following person is blocked under the relevant sanctions authority listed below.
1. BADI, Salah (a.k.a. BADI, Omal Salem Salah; a.k.a. BADI, Saladin; a.k.a. BADI, Salah Edine Omar; a.k.a. BADI, Salahdin; a.k.a. BADI, Salah-Eddin; a.k.a. BADI, Salahidin), Tripoli, Libya; DOB 23 May 1957; POB Misrata, Libya; nationality Libya; Gender Male (individual) [LIBYA3].
Designated pursuant to Section 1(a)(v) of Executive Order 13726 of April 19, 2016, “Blocking Property and Suspending Entry Into the United States of Persons Contributing to the Situation in Libya” (E.O. 13726) for being a leader of an entity that has, or whose members have, engaged in actions or policies that threaten the peace, security, or stability of Libya, including through the supply of arms or related materiel.
Internal Revenue Service (IRS), Treasury.
Notice.
Publication of the tier 2 tax rates for calendar year 2019 as required by section 3241(d) of the Internal Revenue Code. Tier 2 taxes on railroad employees, employers, and employee representatives are one source of funding for benefits under the Railroad Retirement Act.
The tier 2 tax rates for calendar year 2019 apply to compensation paid in calendar year 2019.
Kathleen Edmondson, CC:TEGE:EOEG:ET1, Internal Revenue Service, 1111 Constitution Avenue NW, Washington, DC 20224, Telephone Number (202) 317-6798 (not a toll-free number).
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act that the Advisory Committee on Women Veterans will meet on December 18-20, 2018, at VA Central Office, 810 Vermont Avenue NW, G.V. Sonny Montgomery Veterans Conference Room 230, Washington, DC 20420. The meetings will be held:
The meetings are open to the public.
The purpose of the Committee is to advise the Secretary of Veterans Affairs regarding the needs of women Veterans with respect to health care, rehabilitation, compensation, outreach, and other programs and activities administered by VA designed to meet such needs. The Committee makes recommendations to the Secretary regarding such programs and activities.
The agenda will include updates from the Veterans Health Administration, the Veterans Benefits Administration, and Staff Offices, as well as briefings on other issues impacting women Veterans.
No time will be allocated at this meeting for receiving oral presentations from the public. Interested parties should provide written comments for review by the Committee to Ms. Shannon L. Middleton, VA Center for Women Veterans (00W), 810 Vermont Avenue NW, Washington, DC 20420, or email at
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act that the Advisory Committee on the Readjustment of Veterans will have a closed meeting at the Department of Veterans Affairs Vet Center 721 at 9504 IH 35, North, San Antonio, Texas 78233. The meetings will be held on December 5 and 6, 2018. Sessions are open to the public, except when the Committee is conducting tours of VA facilities, participating in offsite events, participating in workgroup sessions, and conducting official Administrative business. Tours of the VA facilities are closed, to protect Veterans' privacy and personal information.
The purpose of the Committee is to advise the Department of Veterans Affairs (VA) regarding the provision by VA of benefits and services to assist Veterans in the readjustment to civilian life. In carrying out this duty, the Committee shall take into account the needs of Veterans who served in combat theaters of operation. The Committee assembles, reviews, and assesses information relating to the needs of Veterans readjusting to civilian life and the effectiveness of VA services in assisting Veterans in that readjustment.
On Wednesday, December 5, 2018, the Committee will hold a closed session at the San Antonio, TX Vet Center from 8:00 a.m. to 4:30 p.m., while members tour the facility, and meet with key Vet Center staff as well as a panel of individuals who use Vet Center services. The meeting will focus on Veteran experience, and members will solicit information from key staff from various VA entities across San Antonio, and have strategic discussion about what they learned from the interactions. Because the issues discussed will most likely include information learned during the tour and in conversation with service users, to protect their privacy the session will be closed.
On December 6, the Committee will convene an open session from 8:00 a.m. to 10:00 a.m., when they will receive an update from VA Readjustment Counseling Service and Mental Health leadership regarding collective efforts in suicide prevention, and then will engage in strategic discussions formulating conclusions and recommendations for the 20th annual report to Congress. The meeting will adjourn at 10:00 a.m.
This field visit is closed to the public in accordance with 5 U.S.C. 552b (c) (6). Exemption 6 permits the Committee to close a meeting that is likely to disclose information of a personal nature where disclosure would constitute a clearly unwarranted invasion of personal privacy, which will most likely be the case throughout this field visit.
The agenda will include time for Executive Sessions, where the committee will focus on the annual operations plan for 2019/2020, and no time will be allotted for receiving oral comments from the public; however, the committee will accept written comments from interested parties on issues outlined in the meeting agenda or other issues regarding the readjustment of Veterans. Parties should contact Ms. Sherry Moravy, via email at
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rules and interim final rule.
This major final rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This final rule also finalizes policies included in the interim final rule with comment period in “Medicare Program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year” that address the extreme and uncontrollable circumstances MIPS eligible clinicians faced as a result of widespread catastrophic events affecting a region or locale in CY 2017, such as Hurricanes Irma, Harvey and Maria. In addition, this final rule addresses a subset of the changes to the Medicare Shared Savings Program for Accountable Care Organizations (ACOs) proposed in the August 2018 proposed rule “Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations—Pathways to Success”. This final rule also addresses certain other revisions designed to update program policies under the Shared Savings Program.
The interim final rule implements amendments made by the SUPPORT for Patients and Communities Act to the Medicare telehealth provisions in the Social Security Act and regarding permissible telehealth originating sites for purposes of treatment of a substance use disorder or a co-occurring mental health disorder for telehealth services furnished on or after July 1, 2019 to an individual with a substance use disorder diagnosis.
• Revisions to §§ 414.1415(b)(2) and (3), and 414.1420(b), (c)(2), and (3), which are effective January 1, 2020; and
• Amendments to Part 425, which are effective on December 31, 2018.
In commenting, please refer to file code CMS-1693-IFC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
Comments, including mass comment submissions, must be submitted in one of the following three 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.
For information on viewing public comments, see the beginning of the
Jamie Hermansen, (410) 786-2064, for any physician payment issues not identified below.
Lindsey Baldwin, (410) 786-1694, and Emily Yoder, (410) 786-1804, for issues related to evaluation and management (E/M) payment, communication technology-based services and telehealth services.
Lindsey Baldwin, (410) 786-1694, for issues related to sections 2001(a) and 2005 of the SUPPORT for Patients and Communities Act.
Kathy Bryant, (410) 786-3448, for issues related to global surgery data collection.
Isadora Gil, (410) 786-4532, for issues related to payment rates for nonexcepted items and services furnished by nonexcepted off-campus provider-based departments of a hospital, and work relative value units (RVUs).
Ann Marshall, (410) 786-3059, for issues related to E/M documentation guidelines.
Geri Mondowney, (410) 786-1172, for issues related to potentially misvalued services, geographic price cost indices (GPCIs), and malpractice RVUs.
Donta Henson, (410) 786-1947, for issues related to geographic price cost indices (GPCIs).
Tourette Jackson, (410) 786-4735, for issues related to malpractice RVUs.
Patrick Sartini, (410) 786-9252, for issues related to radiologist assistants.
Michael Soracoe, (410) 786-6312, for issues related to practice expense, work RVUs, impacts, and conversion factor.
Pamela West, (410) 786-2302, for issues related to therapy services.
Edmund Kasaitis, (410) 786-0477, for issues related to reduction of wholesale acquisition cost (WAC)-based payment.
Marcie O'Reilly, (410) 786-9764, for issues related to the Potential Model for Radiation Therapy.
Sarah Harding, (410) 786-4001, or Craig Dobyski, (410) 786-4584, for issues related to aggregate reporting of applicable information for clinical laboratory fee schedule.
Amy Gruber, (410) 786-1542, or Glenn McGuirk, (410) 786-5723, for issues related to the ambulance fee schedule.
Corinne Axelrod, (410) 786-5620, for issues related to care management services and communication technology-based services in Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs).
JoAnna Baldwin, (410) 786-7205, or Sarah Fulton, (410) 786-2749, for issues related to appropriate use criteria for advanced diagnostic imaging services.
Fiona Larbi, (410) 786-7224, for issues related to the Medicare Shared Savings Program (Shared Savings Program) Quality Measures.
Matthew Edgar, (410) 786-0698, for issues related to the physician self-referral law.
Molly MacHarris, (410) 786-4461, for inquiries related to Merit-based Incentive Payment System (MIPS).
Benjamin Chin, (410) 786-0679, for inquiries related to Alternative Payment Models (APMs).
David Koppel, (303) 844-2883, or Elizabeth LeBreton (202) 615-3816 for issues related to the Medicaid Promoting Interoperability Program.
Elizabeth November, (410) 786-8084, for inquiries related to the Medicare Shared Savings Program [Pathways to Success].
The PFS Addenda along with other supporting documents and tables referenced in this final rule are available on the CMS website at
Throughout this final rule, we use CPT codes and descriptions to refer to a variety of services. We note that CPT codes and descriptions are copyright 2018 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association (AMA). Applicable Federal Acquisition Regulations (FAR) and Defense Federal Acquisition Regulations (DFAR) apply.
This major final rule makes payment and policy changes under the Medicare PFS and implements certain provisions of the Bipartisan Budget Act of 2018 (Pub. L. 115-123, February 9, 2018) and the SUPPORT for Patients and Communities Act (Pub. L. 115-271, October 24, 2018) related to Medicare Part B payment, and except as specified otherwise, applicable to services furnished in CY 2019. This final rule also revises certain policies under the Medicare Shared Savings Program.
The statute requires us to establish payments under the PFS based on national uniform relative value units (RVUs) that account for the relative resources used in furnishing a service. The statute requires that RVUs be established for three categories of resources: Work; practice expense (PE); and malpractice (MP) expense. In addition, the statute requires that we establish by regulation each year's payment amounts for all physicians' services paid under the PFS, incorporating geographic adjustments to reflect the variations in the costs of furnishing services in different geographic areas. In this major final rule, we establish RVUs for CY 2019 for the PFS, and other Medicare Part B payment policies, to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This final rule includes discussions regarding:
• Potentially Misvalued Codes.
• Communication Technology-Based Services.
• Provisions Expanding Telehealth Services for the Treatment of Opioid Use Disorder and Other Substance Use Disorders under the SUPPORT Act.
• Valuation of New, Revised, and Misvalued Codes.
• Payment Rates under the PFS for Nonexcepted Items and Services Furnished by Nonexcepted Off-Campus Provider-Based Departments of a Hospital.
• Evaluation & Management (E/M) Visits.
• Therapy Services.
• Part B Drugs: Application of an Add-on Percentage for Certain Wholesale Acquisition Cost (WAC)-based Payments.
• Potential Model for Radiation Therapy.
• Clinical Laboratory Fee Schedule.
• Ambulance Fee Schedule—Provisions in the Bipartisan Budget Act of 2018.
• Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs).
• Appropriate Use Criteria for Advanced Diagnostic Imaging Services.
• Medicaid Promoting Interoperability Program Requirements for Eligible Professionals.
• Medicare Shared Savings Program Quality Measures.
• Physician Self-Referral Law.
• Physician Self-Referral Law: Annual Update to the List of CPT/HCPCS Codes.
• CY 2019 Updates to the Quality Payment Program (including the extreme and uncontrollable circumstances MIPS eligible clinicians faced as a result of widespread catastrophic events affecting a region or locale in CY 2017).
• Comments in response to the Request for Information on Promoting Interoperability and Electronic Healthcare Information Exchange through Possible Revisions to the CMS Patient Health and Safety Requirements for Hospitals and Other Medicare- and Medicaid-Participating Providers and Suppliers.
• Comments in response to the Request for Information on Price Transparency: Improving Beneficiary Access to Provider and Supplier Charge Information.
This rule also finalizes certain provisions from the “Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations—Pathways to Success” proposed rule that appeared in the August 17, 2018
We have determined that this major final rule is economically significant. For a detailed discussion of the economic impacts, see section VII. of this final rule.
Practice expense (PE) is the portion of the resources used in furnishing a service that reflects the general categories of physician and practitioner expenses, such as office rent and personnel wages, but excluding MP expenses, as specified in section 1848(c)(1)(B) of the Act. As required by section 1848(c)(2)(C)(ii) of the Act, we use a resource-based system for determining PE RVUs for each physicians' service. We develop PE RVUs by considering the direct and indirect practice resources involved in furnishing each service. Direct expense categories include clinical labor, medical supplies, and medical equipment. Indirect expenses include administrative labor, office expense, and all other expenses. The sections that follow provide more detailed information about the methodology for translating the resources involved in furnishing each service into service-specific PE RVUs. We refer readers to the CY 2010 PFS final rule with comment period (74 FR 61743 through 61748) for a more detailed explanation of the PE methodology.
We determine the direct PE for a specific service by adding the costs of the direct resources (that is, the clinical staff, medical supplies, and medical equipment) typically involved with furnishing that service. The costs of the resources are calculated using the refined direct PE inputs assigned to each CPT code in our PE database, which are generally based on our review of recommendations received from the RUC and those provided in response to public comment periods. For a detailed explanation of the direct PE methodology, including examples, we refer readers to the Five-Year Review of Work Relative Value Units under the PFS and Proposed Changes to the Practice Expense Methodology CY 2007 PFS proposed notice (71 FR 37242) and the CY 2007 PFS final rule with comment period (71 FR 69629).
We use survey data on indirect PEs incurred per hour worked, in developing the indirect portion of the PE RVUs. Prior to CY 2010, we primarily used the PE/HR by specialty that was obtained from the AMA's SMS. The AMA administered a new survey in CY 2007 and CY 2008, the Physician Practice Expense Information Survey (PPIS). The PPIS is a multispecialty, nationally representative, PE survey of both physicians and NPPs paid under the PFS using a survey instrument and methods highly consistent with those used for the SMS and the supplemental surveys. The PPIS gathered information from 3,656 respondents across 51 physician specialty and health care professional groups. We believe the PPIS is the most comprehensive source of PE survey information available. We used the PPIS data to update the PE/HR data for the CY 2010 PFS for almost all of the Medicare-recognized specialties that participated in the survey.
When we began using the PPIS data in CY 2010, we did not change the PE RVU methodology itself or the manner in which the PE/HR data are used in that methodology. We only updated the PE/HR data based on the new survey. Furthermore, as we explained in the CY 2010 PFS final rule with comment period (74 FR 61751), because of the magnitude of payment reductions for some specialties resulting from the use of the PPIS data, we transitioned its use over a 4-year period from the previous PE RVUs to the PE RVUs developed using the new PPIS data. As provided in the CY 2010 PFS final rule with comment period (74 FR 61751), the transition to the PPIS data was complete for CY 2013. Therefore, PE RVUs from CY 2013 forward are developed based entirely on the PPIS data, except as noted in this section.
Section 1848(c)(2)(H)(i) of the Act requires us to use the medical oncology supplemental survey data submitted in 2003 for oncology drug administration services. Therefore, the PE/HR for medical oncology, hematology, and hematology/oncology reflects the continued use of these supplemental survey data.
Supplemental survey data on independent labs from the College of American Pathologists were implemented for payments beginning in CY 2005. Supplemental survey data from the National Coalition of Quality Diagnostic Imaging Services (NCQDIS), representing independent diagnostic testing facilities (IDTFs), were blended with supplementary survey data from the American College of Radiology (ACR) and implemented for payments beginning in CY 2007. Neither IDTFs, nor independent labs, participated in the PPIS. Therefore, we continue to use the PE/HR that was developed from their supplemental survey data.
Consistent with our past practice, the previous indirect PE/HR values from the supplemental surveys for these specialties were updated to CY 2006 using the Medicare Economic Index (MEI) to put them on a comparable basis with the PPIS data.
We also do not use the PPIS data for reproductive endocrinology and spine surgery since these specialties currently are not separately recognized by Medicare, nor do we have a method to blend the PPIS data with Medicare-recognized specialty data.
Previously, we established PE/HR values for various specialties without SMS or supplemental survey data by crosswalking them to other similar specialties to estimate a proxy PE/HR. For specialties that were part of the PPIS for which we previously used a crosswalked PE/HR, we instead used the PPIS-based PE/HR. We use crosswalks for specialties that did not participate in the PPIS. These crosswalks have been generally established through notice and comment rulemaking and are available in the file called “CY 2019 PFS Final Rule PE/HR” on the CMS website under downloads for the CY 2019 PFS final rule at
For CY 2019, we have incorporated the available utilization data for two new specialties, each of which became a recognized Medicare specialty during 2017. These specialties are Hospitalists and Advanced Heart Failure and Transplant Cardiology. We proposed to use proxy PE/HR values for these new specialties, as there are no PPIS data for these specialties, by crosswalking the PE/HR as follows from specialties that furnish similar services in the Medicare claims data:
• Hospitalists from Emergency Medicine, and
• Advanced Heart Failure and Transplant Cardiology from Cardiology.
These updates are reflected in the “CY 2019 PFS Final Rule PE/HR” file available on the CMS website under the supporting data files for the CY 2019 PFS final rule at
The following is a summary of the public comments we received on our proposal to use proxy PE/HR values for these two new specialties.
After consideration of the public comments, we are finalizing our proposal to use proxy PE/HR values for Hospitalists and Advanced Heart Failure and Transplant Cardiology as described above.
To establish PE RVUs for specific services, it is necessary to establish the direct and indirect PE associated with each service.
The relative relationship between the direct cost portions of the PE RVUs for any two services is determined by the relative relationship between the sum of the direct cost resources (that is, the clinical staff, medical supplies, and medical equipment) typically involved with furnishing each of the services. The costs of these resources are calculated from the refined direct PE inputs in our PE database. For example, if one service has a direct cost sum of $400 from our PE database and another service has a direct cost sum of $200, the direct portion of the PE RVUs of the first service would be twice as much as the direct portion of the PE RVUs for the second service.
We allocate the indirect costs at the code level on the basis of the direct costs specifically associated with a code and the greater of either the clinical labor costs or the work RVUs. We also incorporate the survey data described earlier in the PE/HR discussion (see section II.B.2.b of this final rule). The general approach to developing the indirect portion of the PE RVUs is as follows:
• For a given service, we use the direct portion of the PE RVUs calculated as previously described and the average percentage that direct costs represent of total costs (based on survey data) across the specialties that furnish the service to determine an initial indirect allocator. That is, the initial indirect allocator is calculated so that the direct costs equal the average percentage of direct costs of those specialties furnishing the service. For example, if the direct portion of the PE RVUs for a given service is 2.00 and direct costs, on average, represent 25 percent of total costs for the specialties that furnish the service, the initial indirect allocator would be calculated so that it equals 75 percent of the total PE RVUs. Thus, in this example, the initial indirect allocator would equal 6.00, resulting in a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75 percent of 8.00).
• Next, we add the greater of the work RVUs or clinical labor portion of the direct portion of the PE RVUs to this initial indirect allocator. In our example, if this service had a work RVU of 4.00 and the clinical labor portion of the direct PE RVU was 1.50, we would add 4.00 (since the 4.00 work RVUs are greater than the 1.50 clinical labor portion) to the initial indirect allocator of 6.00 to get an indirect allocator of 10.00. In the absence of any further use of the survey data, the relative relationship between the indirect cost portions of the PE RVUs for any two services would be determined by the relative relationship between these indirect cost allocators. For example, if one service had an indirect cost allocator of 10.00 and another service had an indirect cost allocator of 5.00, the indirect portion of the PE RVUs of the first service would be twice as great as the indirect portion of the PE RVUs for the second service.
• Next, we incorporated the specialty-specific indirect PE/HR data into the calculation. In our example, if, based on the survey data, the average indirect cost of the specialties furnishing the first service with an allocator of 10.00 was half of the average indirect cost of the specialties furnishing the second service with an indirect allocator of 5.00, the indirect portion of the PE RVUs of the first service would be equal to that of the second service.
For procedures that can be furnished in a physician's office, as well as in a facility setting, where Medicare makes a separate payment to the facility for its costs in furnishing a service, we establish two PE RVUs: Facility and nonfacility. The methodology for calculating PE RVUs is the same for both the facility and nonfacility RVUs, but is applied independently to yield two separate PE RVUs. In calculating the PE RVUs for services furnished in a facility, we do not include resources that would generally not be provided by physicians when furnishing the service. For this reason, the facility PE RVUs are generally lower than the nonfacility PE RVUs.
Diagnostic services are generally comprised of two components: A professional component (PC); and a technical component (TC). The PC and TC may be furnished independently or by different providers, or they may be
For a more detailed description of the PE RVU methodology, we refer readers to the CY 2010 PFS final rule with comment period (74 FR 61745 through 61746). We also direct readers to the file called “Calculation of PE RVUs under Methodology for Selected Codes” which is available on our website under downloads for the CY 2019 PFS final rule at
First, we create a setup file for the PE methodology. The setup file contains the direct cost inputs, the utilization for each procedure code at the specialty and facility/nonfacility place of service level, and the specialty-specific PE/HR data calculated from the surveys.
Sum the costs of each direct input.
Create indirect allocators.
We generally use an average of the 3 most recent years of available Medicare claims data to determine the specialty mix assigned to each code. Codes with low Medicare service volume require special attention since billing or enrollment irregularities for a given year can result in significant changes in specialty mix assignment. We finalized a policy in the CY 2018 PFS final rule (82 FR 52982 through 59283) to use the most recent year of claims data to determine which codes are low volume for the coming year (those that have fewer than 100 allowed services in the Medicare claims data). For codes that fall into this category, instead of assigning specialty mix based on the specialties of the practitioners reporting the services in the claims data, we instead use the expected specialty that we identify on a list developed based on medical review and input from expert stakeholders. We display this list of expected specialty assignments as part of the annual set of data files we make available as part of notice and comment rulemaking and consider recommendations from the RUC and other stakeholders on changes to this list on an annual basis. Services for which the specialty is automatically assigned based on previously finalized policies under our established methodology (for example, “always therapy” services) are unaffected by the list of expected specialty assignments. We also finalized in the CY 2018 PFS final rule (82 FR 52982 through 59283) a policy to apply these service-level overrides for both PE and MP, rather than one or the other category.
For CY 2019, we proposed to add 28 additional codes that we identified as low volume services to the list of codes for which we assign the expected specialty. Based on our own medical review and input from the RUC and from specialty societies, we proposed to assign the expected specialty for each code as indicated in Table 1. For each of these codes, only the professional component (reported with the -26 modifier) is nationally priced. The global and technical components are priced by the Medicare Administrative Contractors (MACs) which establish RVUs and payment amounts for these services. The list of codes that we proposed to add is displayed in Table 1.
The complete list of expected specialty assignments for individual low volume services, including the assignments for the codes identified in Table 1, is available on our website under downloads for the CY 2019 PFS final rule at
The following is a summary of the public comments we received on our proposal to update the list of expected specialty assignments for low volume services.
• Cardiac Surgery: CPT code 35812, and
• Thoracic Surgery: CPT codes 32654, 33025 and 33251
After consideration of the public comments, we are finalizing the addition of the proposed 28 codes to the low volume services list, with the expected specialty as proposed except where modified in response to comments. We are also finalizing the addition of CPT codes 32654 and 33251 to the list with an expected specialty of Thoracic Surgery as detailed previously.
For most services the indirect allocator is: Indirect PE percentage * (direct PE RVUs/direct percentage) + work RVUs.
There are two situations where this formula is modified:
• If the service is a global service (that is, a service with global, professional, and technical components), then the indirect PE allocator is: Indirect percentage (direct PE RVUs/direct percentage) + clinical labor PE RVUs + work RVUs.
• If the clinical labor PE RVUs exceed the work RVUs (and the service is not a global service), then the indirect allocator is: Indirect PE percentage (direct PE RVUs/direct percentage) + clinical labor PE RVUs.
(
For presentation purposes, in the examples in the download file called “Calculation of PE RVUs under Methodology for Selected Codes”, the formulas were divided into two parts for each service.
• The first part does not vary by service and is the indirect percentage (direct PE RVUs/direct percentage).
• The second part is either the work RVU, clinical labor PE RVU, or both depending on whether the service is a global service and whether the clinical PE RVUs exceed the work RVUs (as described earlier in this step).
Apply a scaling adjustment to the indirect allocators.
Calculate the indirect practice cost index.
The following is a summary of the public comments we received on the indirect practice cost indices.
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We also make adjustments to volume and time that correspond to other payment rules, including special multiple procedure endoscopy rules and multiple procedure payment reductions (MPPRs). We note that section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments for multiple imaging procedures and multiple therapy services from the BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These MPPRs are not included in the development of the RVUs.
For anesthesia services, we do not apply adjustments to volume since we use the average allowed charge when simulating RVUs; therefore, the RVUs as calculated already reflect the payments as adjusted by modifiers, and no volume adjustments are necessary. However, a time adjustment of 33 percent is made only for medical direction of two to four cases since that is the only situation where a single practitioner is involved with multiple beneficiaries concurrently, so that counting each service without regard to the overlap with other services would overstate the amount of time spent by the practitioner furnishing these services.
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The equipment cost per minute is calculated as:
Stakeholders have often suggested that particular equipment items are used less frequently than 50 percent of the time in the typical setting and that CMS should reduce the equipment utilization rate based on these recommendations. We appreciate and share stakeholders' interest in using the most accurate assumption regarding the equipment utilization rate for particular equipment items. However, we believe that absent robust, objective, auditable data regarding the use of particular items, the 50 percent assumption is the most appropriate within the relative value system. We welcome the submission of data that would support an alternative rate.
This section focuses on specific PE inputs. The direct PE inputs are included in the CY 2019 direct PE input database, which is available on the CMS website under downloads for the CY 2019 PFS final rule at
As we noted in the CY 2015 PFS final rule with comment period (79 FR 67640-67641), we continue to make improvements to the direct PE input database to provide the number of clinical labor minutes assigned for each task for every code in the database
In the CY 2016 PFS final rule with comment period (80 FR 70901), we solicited comments on the appropriate standard minutes for the clinical labor tasks associated with services that use digital technology. After consideration of comments received, we finalized standard times for clinical labor tasks associated with digital imaging at 2 minutes for “Availability of prior images confirmed”, 2 minutes for “Patient clinical information and questionnaire reviewed by technologist, order from physician confirmed and exam protocoled by radiologist”, 2 minutes for “Review examination with interpreting MD”, and 1 minute for “Exam documents scanned into PACS.” Exam completed in RIS system to generate billing process and to populate images into Radiologist work queue.” In the CY 2017 PFS final rule (81 FR 80184 through 80186), we finalized a policy to establish a range of appropriate standard minutes for the clinical labor activity, “Technologist QCs images in PACS, checking for all images, reformats, and dose page.” These standard minutes will be applied to new and revised codes that make use of this clinical labor activity when they are reviewed by us for valuation. We finalized a policy to establish 2 minutes as the standard for the simple case, 3 minutes as the standard for the intermediate case, 4 minutes as the standard for the complex case, and 5 minutes as the standard for the highly complex case. These values were based upon a review of the existing minutes assigned for this clinical labor activity; we determined that 2 minutes is the duration for most services and a small number of codes with more complex forms of digital imaging have higher values.
We also finalized standard times for clinical labor tasks associated with pathology services in the CY 2016 PFS final rule with comment period (80 FR 70902) at 4 minutes for “Accession specimen/prepare for examination”, 0.5 minutes for “Assemble and deliver slides with paperwork to pathologists”, 0.5 minutes for “Assemble other light microscopy slides, open nerve biopsy slides, and clinical history, and present to pathologist to prepare clinical pathologic interpretation”, 1 minute for “Clean room/equipment following procedure”, 1 minute for “Dispose of remaining specimens, spent chemicals/other consumables, and hazardous waste”, and 1 minute for “Prepare, pack and transport specimens and records for in-house storage and external storage (where applicable).” We do not believe these activities would be dependent on number of blocks or batch size, and we believe that these values accurately reflect the typical time it takes to perform these clinical labor tasks.
Historically, the RUC has submitted a “PE worksheet” that details the recommended direct PE inputs for our use in developing PE RVUs. The format of the PE worksheet has varied over time and among the medical specialties developing the recommendations. These variations have made it difficult for both the RUC's development and our review of code values for individual codes. Beginning with its recommendations for CY 2019, the RUC has mandated the use of a new PE worksheet for purposes of their recommendation development process that standardizes the clinical labor tasks and assigns them a clinical labor activity code. We believe the RUC's use of the new PE worksheet in developing and submitting recommendations will help us to simplify and standardize the hundreds of different clinical labor tasks currently listed in our direct PE database. As we did for CY 2018, to facilitate rulemaking for CY 2019, we are continuing to display two versions of the Labor Task Detail public use file: one version with the old listing of clinical labor tasks, and one with the same tasks cross-walked to the new listing of clinical labor activity codes. These lists are available on the CMS website under downloads for the CY 2019 PFS final rule at
In reviewing the RUC-recommended direct PE inputs for CY 2019, we noticed that the 3 minutes of clinical labor time traditionally assigned to the “Prepare room, equipment and supplies” (CA013) clinical labor activity were split into 2 minutes for the “Prepare room, equipment and supplies” activity and 1 minute for the “Confirm order, protocol exam” (CA014) activity. These RUC-reviewed codes do not currently have clinical labor time assigned for the “Confirm order, protocol exam” clinical labor task, and we do not have any reason to believe that the services being furnished by the clinical staff have changed, only the way in which this clinical labor time has been presented on the PE worksheets.
As a result, we proposed to maintain the 3 minutes of clinical labor time for the “Prepare room, equipment and supplies” activity and remove the clinical labor time for the “Confirm order, protocol exam” activity wherever we observed this pattern in the RUC-recommended direct PE inputs. If we had received RUC recommendations for codes that currently include clinical labor time for the “Confirm order, protocol exam” clinical labor task, we would have left the RUC-recommended clinical labor times unchanged, but there were no such codes reviewed for CY 2019. We note that there is no effect on the total clinical labor direct costs in these situations, since the same 3 minutes of clinical labor time is still being used in the calculation of PE RVUs.
The following is a summary of the public comments we received on our proposal to maintain the 3 minutes of clinical labor time for the “Prepare room, equipment and supplies” activity and remove the clinical labor time for the “Confirm order, protocol exam” activity wherever we observed the aforementioned pattern in the RUC-recommended direct PE inputs.
However, when reviewing the clinical labor for the reviewed codes affected by this issue, we found that several of the codes did not include the old clinical labor task “Patient clinical information and questionnaire reviewed by technologist, order from physician confirmed and exam protocoled by radiologist” on a prior version of the PE worksheet. We also noted that several of the reviewed codes that contained the CA014 clinical labor activity code for “Confirm order, protocol exam” did not contain any clinical labor for the CA007 activity (“Review patient clinical extant information and questionnaire”). In these situations, we believe that it is more accurate to finalize our direct PE refinements to maintain the 3 minutes of clinical labor time for the “Prepare room, equipment and supplies” activity and remove the clinical labor time for the “Confirm order, protocol exam” activity as proposed, since the rationale provided by the commenters does not appear to be the case. These codes do not appear to be an instance where the old clinical labor task was split into two new clinical labor activities. We do not understand how time assigned to an old clinical labor task could be divided between the CA007 and CA014 activity codes, as the commenters suggested, in situations where the code under review does not contain any clinical labor for the CA007 activity. We continue to believe that in these cases the 3 total minutes of clinical staff time would be more accurately described by the CA013 “Prepare room, equipment and supplies” activity code, as these codes do not currently have clinical labor time assigned for the CA014 “Confirm order, protocol exam” clinical labor activity.
After consideration of the public comments, we are finalizing our proposal for the reviewed codes that did not include the old clinical labor task described above and do not contain any clinical labor for the CA007 clinical labor activity. We are therefore finalizing our proposal for CPT codes 27369, 38792, 76870, 77012, 77021, 92273, and 92274. We are not finalizing our proposal for the reviewed codes where we were able to determine that the old clinical labor task had been divided into the CA007 and CA014 activity codes as described by the commenters. We are therefore finalizing the RUC-recommended CA013 and CA014 clinical labor for CPT codes 76978, 76981, and 76982.
During our routine reviews of direct PE input recommendations, we have regularly found unexplained inconsistencies involving the use of scopes and the video systems associated with them. Some of the scopes include video systems bundled into the equipment item, some of them include scope accessories as part of their price, and some of them are standalone scopes with no other equipment included. It is not always clear which equipment items related to scopes fall into which of these categories. We have also frequently found anomalies in the equipment recommendations, with equipment items that consist of a scope and video system bundle recommended, along with a separate scope video system. Based on our review, the variations do not appear to be consistent with the different code descriptions.
To promote appropriate relativity among the services and facilitate the transparency of our review process, during the review of the recommended direct PE inputs for the CY 2017 PFS proposed rule, we developed a structure that separates the scope, the associated video system, and any scope accessories that might be typical as distinct equipment items for each code. Under this approach, we proposed standalone prices for each scope, and separate prices for the video systems and accessories that are used with scopes.
Beginning in the CY 2017 proposed rule (81 FR 46176 through 46177), we proposed standardizing refinements to the way scopes have been defined in the direct PE input database. We believe that there are four general types of scopes: Non-video scopes; flexible
We proposed these changes only for the reviewed codes for CY 2017 that made use of scopes, along with updated prices for the equipment items related to scopes utilized by these services. We did not propose to apply these policies to codes with inputs reviewed prior to CY 2017. We also solicited comment on this separate pricing structure for scopes, scope video systems, and scope accessories, which we could consider proposing to apply to other codes in future rulemaking. We did not finalize price increases for a series of other scopes and scope accessories, as the invoices submitted for these components indicated that they are different forms of equipment with different product IDs and different prices. We did not receive any data to indicate that the equipment on the newly submitted invoices was more typical in its use than the equipment that we were currently using for pricing.
We did not make further changes to existing scope equipment in CY 2017 to allow the RUC's PE Subcommittee the opportunity to provide feedback. However, we believed there was some miscommunication on this point, as the RUC's PE Subcommittee workgroup that was created to address scope systems stated that no further action was required following the finalization of our proposal. Therefore, we made further proposals in CY 2018 (82 FR 33961 through 33962) to continue clarifying scope equipment inputs, and sought comments regarding the new set of scope proposals. We considered creating a single scope equipment code for each of the five categories detailed in this rule: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video flexible scope; (4) a non-channeled flexible video scope; and (5) a channeled flexible video scope. Under the current classification system, there are many different scopes in each category depending on the medical specialty furnishing the service and the part of the body affected. We stated our belief that the variation between these scopes was not significant enough to warrant maintaining these distinctions, and we believed that creating and pricing a single scope equipment code for each category would help provide additional clarity. We sought public comment on the merits of this potential scope organization, as well as any pricing information regarding these five new scope categories.
After considering the comments on the CY 2018 PFS proposed rule, we did not finalize our proposal to create and price a single scope equipment code for each of the five categories previously identified. Instead, we supported the recommendation from the commenters to create scope equipment codes on a per-specialty basis for six categories of scopes as applicable, including the addition of a new sixth category of multi-channeled flexible video scopes. Our goal is to create an administratively simple scheme that will be easier to maintain and help to reduce administrative burden. We look forward to receiving detailed recommendations from expert stakeholders regarding the scope equipment items that would be typically required for each scope category, as well as the proper pricing for each scope.
We proposed in the CY 2017 PFS proposed rule (81 FR 46176 through 46177) to define the scope video system as including: (1) A monitor; (2) a processor; (3) a form of digital capture; (4) a cart; and (5) a printer. We believe that these equipment components represent the typical case for a scope video system. Our model for this system was the “video system, endoscopy (processor, digital capture, monitor, printer, cart)” equipment item (ES031), which we proposed to re-price as part of this separate pricing approach. We obtained current pricing invoices for the endoscopy video system as part of our investigation of these issues involving scopes, which we proposed to use for this re-pricing. In response to comments, we finalized the addition of a digital capture device to the endoscopy video system (ES031) in the CY 2017 PFS final rule (81 FR 80188). We finalized our proposal to price the system at $33,391, based on component prices of $9,000 for the processor, $18,346 for the digital capture device, $2,000 for the monitor, $2,295 for the printer, and $1,750 for the cart. In the CY 2018 PFS final rule (82 FR 52991 through 52993), we outlined, but did not finalize, a proposal to add an LED light source into the cost of the scope video system (ES031), which would remove the need for a separate light source in these procedures. We also described a proposal to increase the price of the scope video system by $1,000 to cover the expense of miscellaneous small equipment associated with the system that falls below the threshold of individual equipment pricing as scope accessories (such as cables, microphones, foot pedals, etc.). With the addition of the LED light (equipment code EQ382 at a price of $1,915), the updated total price of the scope video system would be set at $36,306. We did not finalize this updated pricing to the scope video system in CY 2018, and indicated our intention to address these changes in CY 2019 to incorporate feedback from expert stakeholders.
We understand that there may be other accessories associated with the use of scopes. We finalized a proposal in the CY 2017 PFS final rule (81 FR 80188) to separately price any scope accessories outside the use of the scope video system, and individually evaluate their inclusion or exclusion as direct PE inputs for particular codes as usual under our current policy based on whether they are typically used in furnishing the services described by the particular codes.
We understand that the RUC has convened a Scope Equipment Reorganization Workgroup that will be incorporating feedback from expert stakeholders with the intention of making recommendations to us on scope organization and scope pricing. Since the workgroup was not convened in time to submit recommendations for the CY 2019 PFS rulemaking cycle, we proposed to delay proposals for any further changes to scope equipment until CY 2020 so that we can incorporate the feedback from the aforementioned workgroup. However, we proposed to update the price of the scope video system (ES031) from its current price of $33,391 to a price of $36,306 to reflect the addition of the LED light and miscellaneous small equipment associated with the system that falls below the threshold of individual equipment pricing as scope accessories, as we explained in detail in the CY 2018 PFS final rule (82 FR 52992 through 52993). We also proposed to update the name of the ES031
The following is a summary of the public comments we received on our proposals involving scopes and scope systems.
After consideration of the public comments, we are finalizing our scope proposals for CY 2019 without refinement.
Several stakeholders contacted CMS with regard to the use of the kit, sinus surgery, balloon (maxillary, frontal, or sphenoid) (SA106) supply in CPT codes 31295 (Nasal/sinus endoscopy, surgical; with dilation of maxillary sinus ostium (
When CPT codes 31295 through 31297 were initially reviewed during the CY 2011 and CY 2012 PFS rulemaking cycles (75 FR 73251, and 76 FR 73184 through 73186, respectively), we expressed our reservations about the pricing and the typical quantity of this supply item used in furnishing these services. The RUC recommended for the CY 2012 rulemaking cycle that CMS remove the balloon sinus surgery kit from each of these codes and implement separately billable alpha-numeric HCPCS codes to allow practitioners to be paid the cost of the disposable kits per patient encounter instead of per CPT code. We stated at the time, and we continue to believe, that this option presents a series of potential problems that we have addressed previously in the context of the broader challenges regarding our ability to price high cost disposable supply items. (For a discussion of this issue, we direct the reader to our discussion in the CY 2011 PFS final rule with comment period (75 FR 73251)). We stated at the time that since the balloon sinus surgery kits can be used when furnishing more than one service to the same beneficiary on the same day, we believed that it would be appropriate to include 0.5 balloon sinus surgery kits for each of the three codes, and we have maintained this 0.5 supply quantity when CPT codes 31295-31297 were recently reviewed again in CY 2018.
In light of the additional information supplied by the stakeholders, we solicited comments on two aspects of the use of the balloon sinus surgery kit (SA106) supply. First, we solicited comments on whether the 0.5 supply quantity of the balloon sinus surgery kit in CPT codes 31295-31297 would be typical for these procedures. We are concerned that the same kit can be used when furnishing more than one service to the same beneficiary on the same day, and that even the 0.5 supply quantity may be overstating the resources typically needed to furnish each service. Second, we solicited comments on the pricing of the balloon sinus surgery kit, given that we have received letters stating that the price has decreased since the initial pricing in the CY 2011 final rule. See Table 5 for the current component pricing of the balloon sinus surgery kit.
We are interested in any information regarding possible changes in the pricing for this kit or its individual components since the initial pricing we adopted in CY 2011. The following is a summary of the public comments we received on our comment solicitation regarding the balloon sinus surgery kit supply.
With regards to the number of sinus dilation procedures that typically can be performed per balloon, the commenter repeated that the variability inherent in the underlying patient anatomy makes it extremely difficult to assign a fixed number of sinuses that can be dilated per balloon. The commenter also urged CMS to consider a shift away from the current supply methodology and instead create a separate HCPCS code for the balloon sinus surgery kit which would be billable based on the number of balloons used per patient. The commenter stated that should CMS elect to preserve the current policy of assigning a fixed number of sinus dilations per kit, they recommended maintaining the current supply quantity that allows one kit for every two sinuses, as they were unable to find compelling evidence to support a more appropriate supply amount.
After consideration of the public comments, we are not finalizing any changes to the balloon sinus surgery kit (SA106) supply for CY 2019, outside of the market-based supply and equipment pricing update to the supply cost. We do not believe that we have sufficient information to finalize any other changes to the supply cost or supply quantity in the associated CPT codes at this point in time.
Subsequent to the publication of the CY 2018 PFS final rule, stakeholders alerted us to several clerical inconsistencies in the direct PE database. We proposed to correct these inconsistencies as described below and reflected in the CY 2019 final direct PE input database displayed on the CMS website under downloads for the CY 2019 PFS final rule at
For CY 2019, we proposed to address the following inconsistencies:
• The RUC alerted us that there are 165 CPT codes billed with an office E/M code more than 50 percent of the time in the nonfacility setting that have more minimum multi-specialty visit supply packs (SA048) than post-operative visits included in the code's global period. This indicates that either the inclusion of office E/M services was not accounted for in the code's global period when these codes were initially reviewed by the PE Subcommittee, or that the PE Subcommittee initially approved a minimum multi-specialty visit supply pack for these codes without considering the resulting overlap of supplies between SA048 and the E/M supply pack (SA047). The RUC regarded these overlapping supply packs as a duplication, due to the fact that the quantity of the SA048 supply exceeded the number of postoperative visits, and requested that CMS remove the appropriate number of supply item SA048 from 165 codes. After reviewing the quantity of the SA048 supply pack included for the codes in question, we proposed to refine the quantity of minimum multi-specialty visit packs as displayed in Table 6.
In general, we proposed to align the number of minimum multi-specialty visit packs with the number of post-operative office visits included in these codes. We did not propose any supply pack quantity refinements for CPT codes 11100, 95974, or 95978 since they are being deleted for CY 2019. We also did not propose any supply pack quantity refinements for CPT codes 45300, 46500, 57150, 57160, 58100, 64405, 95970, or HCPCS code G0268 since these codes were reviewed by the RUC this year and their previous direct PE inputs will be superseded by the new direct PE inputs we establish through this rulemaking process for CY 2019.
After consideration of the public comments, we are finalizing our proposal to align the number of minimum multi-specialty visit packs with the number of post-operative office visits included in these CPT codes listed in Table 6, with the exception of CPT code 43200 as detailed above.
A stakeholder notified us regarding a potential rank order anomaly in the direct PE inputs established for the Shaving of Epidermal or Dermal Lesions code family through PFS rulemaking for CY 2013. Three of these CPT codes describe benign shave removal of increasing lesion sizes: CPT code 11310 (Shaving of epidermal or dermal lesion, single lesion, face, ears, eyelids, nose, lips, mucous membrane; lesion diameter 0.5 cm or less), CPT code 11311 (Shaving of epidermal or dermal lesion, single lesion, face, ears, eyelids, nose, lips, mucous membrane; lesion diameter 0.6 to 1.0 cm), and CPT code 11312 (Shaving of epidermal or dermal lesion, single lesion, face, ears, eyelids, nose, lips, mucous membrane; lesion diameter 1.1 to 2.0 cm). Each of these codes has a progressively higher work RVU corresponding to the increasing lesion diameter, and the recommended direct PE inputs also increase progressively from CPT codes 11310 to 11311 to 11312. However, the nonfacility PE RVU we established for CPT code 11311 is lower than the nonfacility PE RVU for CPT code 11310, which the stakeholder suggested may represent a rank order anomaly.
We reviewed the direct PE inputs for CPT code 11311 and found that there were clerical inconsistencies in the data entry that resulted in the assignment of the lower nonfacility PE RVU for CPT code 11311. We proposed to revise the direct PE inputs to reflect the ones previously finalized through rulemaking for CPT code 11311.
• In CY 2018, we inadvertently assigned too many minutes of clinical labor time for the “Obtain vital signs” task to three therapy codes, given that these codes are typically billed in multiple units and in conjunction with other therapy codes for the same patient on the same day, and we do not believe that it would be typical for clinical staff to obtain vital signs for each time a code is reported. The codes are: CPT code 97124 (Therapeutic procedure, 1 or more areas, each 15 minutes; massage, including effleurage, petrissage and/or tapotement (stroking, compression, percussion)); CPT code 97750 (Physical performance test or measurement (
Therefore, we proposed to refine the “Obtain vital signs” clinical labor task for these three codes back to their previous times of 1 minute for CPT codes 97124 and 97750 and to 3 minutes for CPT code 97755. We also proposed to refine the equipment time for the table, mat, hi-lo, 6 x 8 platform (EF028) for CPT code 97124 to reflect the change in the clinical labor time.
We received a letter from a commenter alerting us to an anomaly in the direct PE inputs for CPT code 52000 (Cystourethroscopy (separate procedure)). The commenter stated that the inclusion of an endoscope disinfector, rigid or fiberoptic, w-cart equipment item (ES005) was inadvertently overlooked in the recommendations for CPT code 52000 when it was reviewed during PFS rulemaking for CY 2017, and that the equipment would be necessary for endoscope sterilization. The commenter requested that this piece of equipment should be added to the direct PE inputs for CPT code 52000.
After reviewing the direct PE inputs for this code, we agreed with the commenter and we proposed to add the endoscope disinfector (ES005) to CPT code 52000, and to add 22 minutes of equipment time for that item to match the equipment time of the other non-scope items included in this code.
The following is a summary of the public comments we received on additional technical corrections to the direct PE input database and supporting files.
Listed in order, the commenter identified these issues:
We also received comments regarding a variety of subjects about which we did not make proposals for CY 2019. These included comments regarding: The level of physician supervision for CPT code 99091, the 7 percent reduction to the technical component of computed radiography services not performed using digital radiography, a request to migrate the RUC recommended RVU assignment of CPT code 77387 to HCPCS code G6017, a request that CMS not finalize the proposed changes in payment for the revascularization codes (CPT codes 37225-37231) that were a byproduct of the E/M proposals and the supply/equipment pricing update, a request that CMS should assign direct cost inputs and PE RVUs to several disposable negative pressure wound therapy codes (CPT codes 97607-97608), a disagreement with previous reductions in the payment rate for HCPCS code G0416 from past calendar years, a request for clarification regarding the facility PE RVUs for CPT code 99153, a request for CMS to provide additional reimbursement stability for vascular access services by increasing the work RVUs and direct PE inputs for these codes (CPT codes 36901-36909), and a request for CMS to study the possible effect of tariffs on the cost of imaging equipment manufactured overseas. These comments are considered out of scope for the CY 2019 PFS final rule, as we did not make any proposals on these issues in the CY 2019 PFS Proposed Rule. We will take the feedback from the commenters under consideration for future rulemaking.
After consideration of the public comments, we are finalizing technical corrections to the direct PE input database and supporting files as described above.
In the CY 2011 PFS final rule with comment period (75 FR 73205), we finalized a process to act on public requests to update equipment and supply price and equipment useful life inputs through annual rulemaking, beginning with the CY 2012 PFS proposed rule. For CY 2019, we proposed the following price updates for existing direct PE inputs.
We proposed to update the price of four supplies and one equipment item in response to the public submission of invoices. As these pricing updates were each part of the formal review for a code family, we proposed that the new pricing take effect for CY 2019 for these items instead of being phased in over 4 years. For the details of these proposed price updates, please refer to section II.H. of this final rule, Table 15: Invoices Received for Existing Direct PE Inputs.
Section 220(a) of the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93) provides that the Secretary may collect or obtain information from any eligible professional or any other source on the resources directly or indirectly related to furnishing services for which payment is made under the PFS, and that such information may be used in the determination of relative values for services under the PFS. Such information may include the time involved in furnishing services; the amounts, types and prices of PE inputs; overhead and accounting information for practices of physicians and other suppliers, and any other elements that would improve the valuation of services under the PFS.
As part of our authority under section 1848(c)(2)(M) of the Act, as added by PAMA, we initiated a market research contract with StrategyGen to conduct an in-depth and robust market research study to update the PFS direct PE inputs (DPEI) for supply and equipment pricing for CY 2019. These supply and equipment prices were last systematically developed in 2004-2005. StrategyGen has submitted a report with updated pricing recommendations for approximately 1300 supplies and 750 equipment items currently used as direct PE inputs. This report is available as a public use file displayed on the CMS website under downloads for the CY 2019 PFS final rule at
The StrategyGen team of researchers, attorneys, physicians, and health policy experts conducted a market research study of the supply and equipment items currently used in the PFS direct PE input database. Resources and methodologies included field surveys, aggregate databases, vendor resources, market scans, market analysis, physician substantiation, and statistical analysis to estimate and validate current prices for medical equipment and medical supplies. StrategyGen conducted secondary market research on each of the 2,072 DPEI medical equipment and supply items that CMS identified from the current DPEI. The primary and secondary resources StrategyGen used to gather price data and other information were:
• Telephone surveys with vendors for top priority items (Vendor Survey).
• Physician panel validation of market research results, prioritized by total spending (Physician Panel).
• The General Services Administration system (GSA).
• An aggregate health system buyers database with discounted prices (Buyers).
• Publicly available vendor resources, that is, Amazon Business, Cardinal Health (Vendors).
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StrategyGen prioritized the equipment and supply research based on current share of PE RVUs attributable by item provided by CMS. StrategyGen developed the preliminary Recommended Price (RP) methodology based on the following rules in hierarchical order considering both data representativeness and reliability.
1. If the market share, as well as the sample size, for the top three commercial products were available, the weighted average price (weighted by percent market share) was the reported RP. Commercial price, as a weighted average of market share, represents a more robust estimate for each piece of
2. If StrategyGen did not have market share for commercial products, then they used a weighted average (weighted by sample size) of the commercial price and GSA price for the RP. The impact of the GSA price may be nominal in some of these cases since it is proportionate to the commercial samples sizes.
3. Otherwise, if single price points existed from alternate supplier sites, the RP was the weighted average of the commercial price and the GSA price.
4. Finally, if no data were available for commercial products, the GSA average price was used as the RP; and when StrategyGen could find no market research for a particular piece of equipment or supply item, the current CMS prices were used as the RP.
After reviewing the StrategyGen report, we proposed to adopt the updated direct PE input prices for supplies and equipment as recommended by StrategyGen. For the reasons subsequently discussed, the GSA price was not incorporated into the calculation for the StrategyGen recommended prices printed in the proposed rule. The proposed recommended price was developed as follows:
StrategyGen found that despite technological advancements, the average commercial price for medical equipment and supplies has remained relatively consistent with the current CMS price. Specifically, preliminary data indicate that there was no statistically significant difference between the estimated commercial prices and the current CMS prices for both equipment and supplies. This cumulative stable pricing for medical equipment and supplies appears similar to the pricing impacts of non-medical technology advancements where some historically high-priced equipment (that is, desktop PCs) has been increasingly substituted with current technology (that is, laptops and tablets) at similar or lower price points. However, while there were no statistically significant differences in pricing at the aggregate level, medical specialties will experience increases or decreases in their Medicare payments if CMS were to adopt the pricing updates recommended by StrategyGen. At the service level, there may be large shifts in PE RVUs for individual codes that happened to contain supplies and/or equipment with major changes in pricing, although we note that codes with a sizable PE RVU decrease would be limited by the requirement to phase in significant reductions in RVUs, as required by section 1848(c)(7) of the Act. The phase-in requirement limits the maximum RVU reduction for codes that are not new or revised to 19 percent in any individual calendar year.
We believe that it is important to make use of the most current information available for supply and equipment pricing instead of continuing to rely on pricing information that is more than a decade old. Given the potentially significant changes in payment that would occur, both for specific services and more broadly at the specialty level, we proposed to phase in our use of the new direct PE input pricing over a 4-year period using a 25/75 percent (CY 2019), 50/50 percent (CY 2020), 75/25 percent (CY 2021), and 100/0 percent (CY 2022) split between new and old pricing. This approach is consistent with how we have previously incorporated significant new data into the calculation of PE RVUs, such as the 4-year transition period finalized in CY 2007 PFS final rule with comment period when changing to the “bottom-up” PE methodology (71 FR 69641). This transition period will not only ease the shift to the updated supply and equipment pricing, but will also allow interested parties an opportunity to review and respond to the new pricing information associated with their services.
We proposed to implement this phase-in over 4 years so that supply and equipment values transition smoothly from the prices we currently include to the final updated prices in CY 2022. We proposed to implement this pricing transition such that one quarter of the difference between the current price and the fully phased in price is implemented for CY 2019, one third of the difference between the CY 2019 price and the final price is implemented for CY 2020, and one half of the difference between the CY 2020 price and the final price is implemented for CY 2021, with the new direct PE prices fully implemented for CY 2022. An example of the proposed transition from the current to the fully-implemented new pricing is provided in Table 7.
For new supply and equipment codes for which we establish prices during the transition years (CYs 2019, 2020 and 2021) based on the public submission of invoices, we proposed to fully implement those prices with no transition since there are no current prices for these supply and equipment items. These new supply and equipment codes would immediately be priced at their newly established values. We also proposed that, for existing supply and equipment codes, when we establish prices based on invoices that are submitted as part of a revaluation or comprehensive review of a code or code family, they will be fully implemented for the year they are adopted without being phased in over the 4-year pricing transition. The formal review process for a HCPCS code includes a review of pricing of the supplies and equipment included in the code. When we find that the price on the submitted invoice is typical for the item in question, we believe it would be appropriate to finalize the new pricing immediately along with any other revisions we adopt for the code valuation.
For existing supply and equipment codes that are not part of a comprehensive review and valuation of a code family and for which we establish prices based on invoices submitted by the public, we proposed to implement the established invoice price as the updated price and to phase in the new price over the remaining years of the proposed 4-year pricing transition. During the proposed transition period, where price changes for supplies and
We believed that implementing the proposed updated prices with a 4-year phase-in would improve payment accuracy, while maintaining stability and allowing stakeholders the opportunity to address potential concerns about changes in payment for particular items. Updating the pricing of direct PE inputs for supplies and equipment over a longer time frame will allow more opportunities for public comment and submission of additional, applicable data. We welcomed feedback from stakeholders on the proposed updated supply and equipment pricing, including the submission of additional invoices for consideration. We were particularly interested in comments regarding the supply and equipment pricing for CPT codes 95165 and 95004 that are frequently used by the Allergy/Immunology specialty. The Allergy/Immunology specialty was disproportionately affected by the updated pricing, even with a 4-year phase-in. The direct PE costs for CPT code 95165 would go down from $8.43 to $8.17 as a result of the updated supply and equipment pricing information. This would result in the PE RVU for CPT code 96165 to decrease from 0.30 to 0.26. We are seeking feedback on the supply and equipment pricing for the affected codes typically performed by this specialty and whether the direct PE inputs should be reviewed along with the pricing. The full report from the contractor, including the updated supply and equipment pricing that we proposed to be implemented over the proposed 4-year transition period, will be made available as a public use file displayed on the CMS website under downloads for the CY 2019 PFS final rule at
The following is a summary of the public comments we received on our proposals associated with the market research study to update the PFS direct PE inputs for supply and equipment pricing.
The proprietary database of buyer reported pricing offers three advantages: (1) It represents discounted prices as opposed to retail pricing, (2) It has the largest sample sizes to represent a wider range of pricing as opposed to single invoices, and (3) The database provides variety with respect to the purchaser's geographic location, purchasing method, procedure volume and other purchasing arrangements. We initially assumed that GSA also represents typical discounted pricing across regions with smaller sample sizes, but subsequently rejected GSA data because we did not believe that its prices were typically representative of commercially available pricing. As a result, GSA data were
The Buyers database provides the most accurate market pricing estimates that include market discounts for a range of buyer organizations. Its larger sample sizes provide more confidence that the proposed pricing is not skewed toward higher or lower pricing but toward the actual market price paid by purchasers.
The StrategyGen contractors chose not to include invoice research in the market research plan as there is already an existing process to modify Direct Practice Expense Input (DPEI) prices based on invoices. Additionally, the contractors determined that providing specific models and other identifying data with the researched prices would offer a broader and more consistent source of pricing data. We do not agree with the commenters that the updated supply and equipment prices will pressure the financial viability of smaller physician practices, as we believe that the larger sample sizes obtained by StrategyGen's research provide more accurate and more consistent pricing of actual market conditions than the single invoices that we have traditionally been reliant upon for pricing.
As to whether the proposed pricing is representative of prices available to small physician practices and non-facility practitioners generally, one of the objectives of the primary market research was to understand what kind of discounts are available to small physician practices similar to discounted pricing available to large health systems under GPOs. The market research plan included a series of questions to vendors designed to illuminate typical discounts they offer to large and small providers other than GPOs. This market research indicates that there are a variety of discount purchasing options available. Vendors indicated that both volume and timing can influence pricing discounts. Approximately 80 percent of respondents indicated that timing has some impact on the price of equipment, and about half of respondents indicated that timing had some impact on the price of supplies. Discussions with other subject matter experts also indicated that timing of purchase is an important factor in pricing. For example, the end of the sales cycle can drive discounts. Less than 10 percent of vendors indicated that these timing discounts may not be available to smaller practices outside of a GPO. The vendor research also indicated that other factors beyond “size and timing” influence discounted pricing, such as service agreements and bundled purchases.
Research indicates that service agreements often include discounts for equipment and supplies. For example, longer term service agreements generally result in larger discounts. However, some vendors indicated that the effect of service agreements was to reduce the size of the discounts, negatively impacting providers. This may be a difference in service agreement strategies across different vendors. Regardless, only 3 percent of respondents indicated that the availability of service agreement discounts was dependent on a GPO.
The vendors identified other factors that impact pricing decisions including:
• Market demand and competitive pricing;
• Contract renewal;
• Customer history and contract history; and
• Vendor considerations independent of the purchaser such as manufacturer and sales incentives, revenue goals, and new product releases.
In conclusion, while volume purchasing and GPOs can drive down prices for many large providers, these are not the only drivers of discounts for providers. A number of additional factors applicable to large, small, and non-facility practices may result in discounts for the buying organizations. We believe that the pricing update required looking at a broad range of data that was collected from different sources, which included pricing data from both large and small organizations. We note that not all private practices are small in nature, and we do not agree that it would be more accurate to obtain prices only from small practices as opposed to the broader data collection undertaken by the StrategyGen contractor.
For these reasons, the GSA price was not incorporated into the calculation for the StrategyGen recommended prices printed in the proposed rule. The final recommended price for CY 2019 was the commercially researched price, if available. Otherwise the current CY 2018 CMS price remained in place as the CY 2019 CMS price.
The comprehensive market research plan to update DPEI equipment and supplies was designed to supplement the AMA RUC process, not replace it. The current RUC process, while indispensable, does not provide for comprehensive pricing updates. Under the current process, physicians and other providers voluntarily submit invoices for items to RUC for consideration, and after review, the RUC submits these invoices to us. This process results in inherent biases due to the limited number of items represented by submitted invoices and due to the voluntary selection of reported invoices.
The StrategyGen market research plan examined up to five online sources of current prices for each item of equipment or supply researched, including: (1) A proprietary database of buyer reported pricing, (2) Prices offered on GSA (
The comprehensive research plan for the 2019 DPEI required researching approximately 2,000 supply and equipment codes. Qualitative and potentially quantitative research to include all the specialty societies impacted by the DPEI updates was beyond the resources and time allocated to this update. The market research plan did include a physician panel with specialists and a general practitioner to review the reasonableness of the researched data. In addition, the regulatory process remains available to all specialty societies to comment on the recommended prices. We encouraged interested stakeholders to continue to provide feedback on supply and equipment pricing, including the submission of invoices, throughout the 4-year pricing transition.
The prioritization of supply and equipment codes was designed to facilitate understanding and validation of the researched commercial prices for these items. Surveying other market entities, including vendors, as opposed to buyers, was used to more precisely identify the range of commercial pricing and factors impacting those prices. For example, additional priority research included a physician panel that reviewed the researched commercial prices for reasonableness. The prioritization of research for certain codes did not change the recommended commercial prices.
In addition, limited time and resources required prioritizing the codes based on use. We recognize that a few medical supply and equipment codes do not have updated recommended prices, and we continue to welcome the submission of updated pricing information from stakeholders for these and other codes.
We continue to believe that a delay in implementation would be unlikely to result in more accurate pricing information. Therefore, we are finalizing the 4-year pricing transition, beginning in CY 2019. We look forward to working with commenters over the 4-year transition for assistance in identifying individual supply and equipment codes that may require additional research into their pricing. As a reminder, to be included in a given year's proposed rule, we generally need to receive invoices by the same February 10th
For example, a review of the recommended price for the “Antigens, multi” (SH007) supply code identified the need to add pricing data for additional antigens and to refine the unit of measurement used in calculating the price. For SH007, additional antigens were added and data analyzed for 1 milliliter vials of two allergy antigens. The first antigen is an allergy antigen for pollen and mites and contains antigens for Timothy, Birch, Ragweed, Cocklebur, MarshElde, and the mites Dermatophagoides pteronyssinus and Dermatophagoides farina. The second antigen is an allergy antigen for mold and cats and contains antigens for Alternaria, Helminth, Hormoden, Penicillium, and Fel d1. To determine the price of the allergy antigen, the StrategyGen contractor researched each component of the antigen separately and averaged the price of the separate vials as the recommended price to arrive at an updated recommended price of $8.96.
In instances related to equipment, an item may have been improperly priced because a specific component was omitted but the items priced could perform the requisite task. An example of this occurred in the pricing of the “SRS System, SBRT” (ER083) equipment item where the equipment priced would retrofit a system to perform SBRT procedures, but pricing did not include the linear accelerator. When re-examining this specific medical equipment, we ensured it was a linear accelerator with SBRT capabilities and arrived at an updated recommended price of $2,973,721.83.
We reexamined the recommended price of each multi-component item cited by a commenter. Table 9 at the conclusion of this section lists the supply and equipment codes with price changes based on feedback from the commenters and the resulting additional research into pricing.
After consideration of the public comments, we are finalizing our proposals associated with the market research study to update the PFS direct PE inputs for supply and equipment pricing. We continue to believe that implementing the proposed updated prices with a 4-year phase-in will improve payment accuracy, while maintaining stability and allowing stakeholders the opportunity to address potential concerns about changes in payment for particular items. We continue to welcome feedback from stakeholders on the proposed updated supply and equipment pricing, including the submission of additional invoices for consideration. However, while we are adopting most of the prices for supplies and equipment as recommended by StrategyGen and included in the proposed rule, in response to the initial feedback provided by the commenters, we are finalizing changes to the proposed pricing of approximately 60 supply and equipment codes as detailed in Table 9:
The updated supply and equipment pricing as it will be implemented over the 4-year transition period will be made available as a public use file displayed on the CMS website under downloads for the CY 2019 PFS final rule at
To maintain relativity between the clinical labor, supplies, and equipment portions of the PE methodology, we believe that the rates for the clinical labor staff should also be updated along with the updated pricing for supplies and equipment. We solicited public comment regarding whether to update the clinical labor wages used in developing PE RVUs in future calendar years during the 4-year pricing transition for supplies and equipment, or whether it would be more appropriate to update the clinical labor wages at a later date following the conclusion of the transition for supplies and equipment, for example, to avoid other potentially large shifts in PE RVUs during the 4-year pricing transition period.
The following is a summary of the public comments we received on our comment solicitation regarding whether to update of the rates for the clinical labor staff types during the 4-year pricing transition for supplies and equipment.
Following the publication of the CY 2018 PFS final rule, a stakeholder contacted us and requested that we update the price for the Breast Biopsy software (EQ370) equipment. This equipment item currently lacks a price in the direct PE database, and when an invoice for the Breast Biopsy software was first submitted during CY 2014 PFS rulemaking, we stated that this item served clinical functions similar to other items already included in the Magnetic Resonance (MR) room equipment package (EL008) included in the same CPT codes under review. Therefore, we did not create new direct PE inputs for this equipment item (78 FR 74344
After reviewing the use of the Breast Biopsy software (EQ370) equipment in these six codes, we did not propose to update the price or add the software to these procedures. As we stated in the CY 2014 PFS final rule with comment period (78 FR 74345), we continue to believe that equipment item EQ370 serves clinical functions similar to other items already included in the MR room equipment package (EL008), and that it would be duplicative to include this Breast Biopsy software as a separate direct PE input. We also note that the RUC recommendations for the new CPT codes 77048 and 77049 do not include EQ370 in the recommended equipment for these procedures, and we do not have any reason to believe that the inclusion of additional Breast Biopsy software beyond what is already contained in the MR room equipment package would be typical. However, we will update the name of the EQ370 equipment item from “Breast Biopsy software” to the requested “Breast MRI computer aided detection and biopsy guidance software” to help better describe the equipment in question.
The following is a summary of the public comments we received on our proposal not to update the price of the Breast Biopsy software or add the software to the listed procedures.
After consideration of the public comments, we are finalizing our proposal not to update the price of the Breast Biopsy software (EQ370). However, we note that in light of the information supplied by the commenter that the new CAD Software equipment (ED058) is actually synonymous with the Breast Biopsy software (EQ370), we had already proposed to include this equipment in CPT codes 77048 and 77049. We are finalizing the inclusion of the new CAD Software equipment (ED058) in these procedures, and we are finalizing an update in the price of the CAD Software to $43,308.12. This is based on a submitted invoice from the commenters which contained a price of $52,725 as averaged together with additional invoices for the same CAD Software equipment researched by the StrategyGen contractor. We are also finalizing the replacement of the time assigned to the EQ370 Breast Biopsy software in CPT codes 19085, 19086, 19287, and 19288 with an equal amount of time assigned to the new ED058 CAD Software equipment. Finally, due to the continued confusion and lack of price for the EQ370 equipment item, and due to its redundancy with the new ED058 equipment code, we are deleting EQ370.
We routinely accept public submission of invoices as part of our process for developing payment rates for new, revised, and potentially misvalued codes. Often these invoices are submitted in conjunction with the RUC-recommended values for the codes. For CY 2019, we noted that some stakeholders have submitted invoices for new, revised, or potentially misvalued codes after the February 10th deadline established for code valuation recommendations. To be included in a given year's proposed rule, we generally need to receive invoices by the same February 10th deadline we noted for consideration of RUC recommendations. However, we would consider invoices submitted as public comments during the comment period following the publication of the PFS proposed rule, and would consider any invoices received after February 10th or outside of the public comment process as part of our established annual process for requests to update supply and equipment prices.
In the CY 2018 PFS final rule (82 FR 52999 through 53000), we established criteria for identifying the services most affected by the indirect PE allocation anomaly that does not allow for a site of service differential that accurately reflects the relative indirect costs involved in furnishing services in nonfacility settings. We also finalized a modification in the PE methodology for allocating indirect PE RVUs to better reflect the relative indirect PE resources involved in furnishing these services. The methodology, as described, is based on the difference between the ratio of indirect PE to work RVUs for each of the codes meeting eligibility criteria and the ratio of indirect PE to work RVU for the most commonly reported visit code. We refer readers to the CY 2018 PFS final
We received no comments specific to our proposal to continue with the 2nd year of the transition to the standard process for allocating indirect PE. Therefore, we are finalizing our proposal to proceed with the second year of implementing an alternative methodology for the allocation of indirect PE for some office-based services.
Section 1848(c) of the Act requires that the payment amount for each service paid under the PFS be composed of three components: Work; PE; and malpractice (MP) expense. As required by section 1848(c)(2)(C)(iii) of the Act, beginning in CY 2000, MP RVUs are resource-based. Section 1848(c)(2)(B)(i) of the Act also requires that we review, and if necessary adjust, RVUs no less often than every 5 years. In the CY 2015 PFS final rule with comment period, we implemented the third review and update of MP RVUs. For a comprehensive discussion of the third review and update of MP RVUs see the CY 2015 PFS proposed rule (79 FR 40349 through 40355) and final rule with comment period (79 FR 67591 through 67596).
To determine MP RVUs for individual PFS services, our MP methodology is composed of three factors: (1) Specialty-level risk factors derived from data on specialty-specific MP premiums paid by practitioners; (2) service level risk factors derived from Medicare claims data of the weighted average risk factors of the specialties that furnish each service; and (3) an intensity/complexity of service adjustment to the service level risk factor based on either the higher of the work RVU or clinical labor RVU. Prior to CY 2016, MP RVUs were only updated once every 5 years, except in the case of new and revised codes.
In the CY 2016 PFS final rule with comment period (80 FR 70906 through 70910), we finalized a policy to begin conducting annual MP RVU updates to reflect changes in the mix of practitioners providing services (using Medicare claims data), and to adjust MP RVUs for risk, intensity and complexity (using the work RVU or clinical labor RVU). We also finalized a policy to modify the specialty mix assignment methodology (for both MP and PE RVU calculations) to use an average of the 3 most recent years of data instead of a single year of data. Under this approach, for new and revised codes, we generally assign a specialty risk factor to individual codes based on the same utilization assumptions we make regarding the specialty mix we use for calculating PE RVUs and for PFS budget neutrality. We continue to use the work RVU or clinical labor RVU to adjust the MP RVU for each code for intensity and complexity. In finalizing this policy, we stated that the specialty-specific risk factors would continue to be updated through notice and comment rulemaking every 5 years using updated premium data, but would remain unchanged between the 5-year reviews.
In CY 2017, we finalized the 8th GPCI update, which reflected updated MP premium data. We did not propose to use the updated MP premium data to propose updates for CY 2017 to the specialty risk factors used in the calculation of MP RVUs because it was inconsistent with the policy we previously finalized in the CY 2016 PFS final rule with comment period. That is, we indicated that the specialty-specific risk factors would continue to be updated through notice and comment rulemaking every 5 years using updated premium data, but would remain unchanged between the 5-year reviews. However, we solicited comment on whether we should consider doing so, perhaps as early as for CY 2018, prior to the fourth review and update of MP RVUs that must occur no later than CY 2020. After consideration of the comments received, we stated in the CY 2017 PFS final rule that we would consider the possibility of using the updated MP data to update the specialty risk factors used in the calculation of the MP RVUs prior to the next 5-year update in future rulemaking (81 FR 80191 through 80192).
In the CY 2018 PFS proposed rule, we proposed to use the updated MP data to update the specialty risk factors used in calculation of the MP RVUs prior to the next 5-year update (CY 2020). However, in the CY 2018 PFS final rule (82 FR 53000 through 53006), after consideration of the comments received and some differences we observed in the descriptions on the raw rate filings as compared to how those data were categorized to conform with the CMS specialties, we did not finalize our proposal to use the updated MP data. We are required to review, and if necessary, adjust the MP RVUs by CY 2020. We appreciate the feedback provided by commenters in response to the CY 2018 PFS proposed rule.
In the CY 2019 PFS proposed rule, we solicited additional comment regarding the next MP RVU update which must occur by CY 2020. Specifically, we solicited comment on how we might improve the way that specialties in the state-level raw rate filings data are crosswalked for categorization into CMS specialty codes, which are used to develop the specialty-level risk factors and the MP RVUs.
We received a few comments in response to the comment solicitation, and we appreciate the commenters' feedback and input. We will consider the suggestions and information received for future rulemaking, and in particular for the CY 2020 statutorily required update to MP RVUs.
The health care community uses the term “telehealth” broadly to refer to medical services furnished via communication technology. Under current PFS payment rules, Medicare routinely pays for many of these kinds of services. This includes some kinds of remote patient monitoring (either as separate services or as parts of bundled services), interpretations of diagnostic tests when furnished remotely and, under conditions specified in section 1834(m) of the Act, services that would otherwise be furnished in person but are instead furnished via real-time, interactive communication technology. Over the past several years, we have also established several PFS policies to explicitly pay for non-face-to-face services included as part of ongoing care management.
Although all of the kinds of services stated above might be called “telehealth” by patients, other payers and health care providers, we have generally used the term “Medicare telehealth services” to refer to the subset of services defined in section 1834(m) of the Act. Section 1834(m) of the Act defines Medicare telehealth services and specifies the payment amounts and circumstances under which Medicare makes payment for a discrete set of services, all of which must ordinarily be furnished in-person, when they are instead furnished using interactive, real-time telecommunication technology. Section 1834(m)(4)(F)(i) of the Act enumerates certain Medicare telehealth services and section 1834(m)(4)(F)(ii) of the Act allows the Secretary to specify
In the CY 2018 PFS proposed rule (82 FR 53012), we solicited information from the public regarding ways that we might further expand access to telehealth services within the current statutory authority and pay appropriately for services that take full advantage of communication technologies. Commenters were very supportive of CMS expanding access to these kinds of services. Many commenters noted that Medicare payment for telehealth services is restricted by statute, but encouraged CMS to recognize and support technological developments in healthcare.
We believe that the provisions in section 1834(m) of the Act apply particularly to the kinds of professional services explicitly enumerated in the statutory provisions, like professional consultations, office visits, and office psychiatry services. Generally, the services we have added to the telehealth list are similar to these kinds of services. As has long been the case, certain other kinds of services that are furnished remotely using communications technology are not considered “Medicare telehealth services” and are not subject to the restrictions articulated in section 1834(m) of the Act. This is true for services that were routinely paid separately prior to the enactment of the provisions in section 1834(m) of the Act and do not usually include patient interaction (such as remote interpretation of diagnostic imaging tests), and for services that were not discretely defined or separately paid for at the time of enactment and that do include patient interaction (such as chronic care management services).
As we considered the concerns expressed by commenters about the statutory restrictions on Medicare telehealth services, we recognized that the concerns were not limited to the barriers to payment for remotely furnished services like those described by the office visit codes. The commenters also expressed concerns pertaining to the limitations on appropriate payment for evolving physicians' services that are inherently furnished via communication technology, especially as technology and its uses have evolved in the decades since the Medicare telehealth services statutory provision was enacted.
In recent years, we have sought to recognize significant changes in health care practice, especially innovations in the active management and ongoing care of chronically ill patients, and have relied on the medical community to identify and define discrete physicians' services through the CPT Editorial Panel (82 FR 53163). In response to our comment solicitation on Medicare telehealth services in the CY 2018 PFS proposed rule (82 FR 53012), commenters provided many suggestions for how CMS could expand access to telehealth services within the current statutory authority and pay appropriately for services that take full advantage of communication technologies, such as waiving portions of the statutory restrictions using demonstration authority. After considering those comments we recognized that concerns regarding the provisions in section 1834(m) of the Act may have been limiting the degree to which the medical community developed coding for new kinds of services that inherently utilize communication technology. We have come to believe that section 1834(m) of the Act does not apply to all kinds of physicians' services whereby a medical professional interacts with a patient via remote communication technology. Instead, we believe that section 1834(m) of the Act applies to a discrete set of physicians' services that ordinarily involve, and are defined, coded, and paid for as if they were furnished during an in-person encounter between a patient and a health care professional.
For CY 2019, we aimed to increase access for Medicare beneficiaries to physicians' services that are routinely furnished via communication technology by clearly recognizing a discrete set of services that are defined by and inherently involve the use of communication technology. Accordingly, we made several proposals for modernizing Medicare physician payment for communication technology-based services, described below. These services will not be subject to the limitations on Medicare telehealth services in section 1834(m) of the Act because, as we have explained, we do not consider them to be Medicare telehealth services; instead, they will be paid under the PFS like other physicians' services. Additionally, we note that in furnishing these services, practitioners need to comply with any applicable privacy and security laws, including the HIPAA Privacy Rule.
The traditional office visit codes describe a broad range of physicians' services. Historically, we have considered any routine non-face-to-face communication that takes place before or after an in-person visit to be bundled into the payment for the visit itself. In recent years, we have recognized payment disparities that arise when the amount of non-face-to-face work for certain kinds of patients is disproportionately higher than for others, and created coding and separate payment to recognize care management services such as chronic care management and behavioral health integration services (81 FR 80226). We now recognize that advances in communication technology have changed patients' and practitioners' expectations regarding the quantity and quality of information that can be conveyed via communication technology. From the ubiquity of synchronous, audio/video applications to the increased use of patient-facing health portals, a broader range of services can be furnished by health care professionals via communication technology as compared to 20 years ago.
Among these services are the kinds of brief check-in services furnished using communication technology that are used to evaluate whether or not an office visit or other service is warranted. When these kinds of check-in services are furnished prior to an office visit, then we would currently consider them to be bundled into the payment for the resulting visit, such as through an evaluation and management (E/M) visit
Therefore, we proposed to pay separately, beginning January 1, 2019, for a newly defined type of physicians' service furnished using communication technology. We stated this service would be billable when a physician or other qualified health care professional has a brief non-face-to-face check-in with a patient via communication technology, to assess whether the patient's condition necessitates an office visit. We understand that the kind of communication technology used to furnish these kinds of services has broadened over time and has enhanced the capacity for medical professionals to care for patients. We solicited comment on what types of communication technology are utilized by physicians or other qualified health care professionals in furnishing these services, including whether audio-only telephone interactions are sufficient compared to interactions that are enhanced with video or other kinds of data transmission.
The following discussion summarizes particular definitions and billing rules for these services, as proposed, and more detailed comments we received regarding these aspects of the proposal. Our responses below include information regarding the service definitions and billing requirements applicable for CY 2019.
We appreciate commenters' concerns regarding the potential for overutilization of these services. We plan to monitor utilization with the intention of determining whether changes, such as a frequency limitation on the use of this code, are warranted. We would consider proposing such changes in future rulemaking. We note that, like all other physicians' services billed under the PFS, each of these services must be medically reasonable and necessary to be paid by Medicare.
We further proposed that in instances when the brief communication technology-based service originates from a related E/M service provided within the previous 7 days by the same physician or other qualified health care professional, that this service would be considered bundled into that previous E/M service and would not be separately billable, which is consistent with code descriptor language for CPT code 99441 (Telephone evaluation and management service by a physician or other qualified health care professional who may report evaluation and management services provided to an established patient, parent, or guardian not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion), on which this service is partially modeled. We proposed that in instances when the brief communication technology-based service leads to an E/M service with the same physician or other qualified health care professional, this service would be considered bundled into the pre- or post-visit time of the associated E/M service, and therefore, would not be separately billable. We also noted that this service could be used as part of a treatment regimen for opioid use disorders and other substance use disorders to assess whether the patient's condition requires an office visit.
We proposed pricing this distinct service at a rate lower than current E/M in-person visits to reflect the low work time and intensity and to account for the resource costs and efficiencies associated with the use of communication technology. We expect that these services will be initiated by the patient, especially since many beneficiaries would be financially liable for sharing in the cost of these services. For the same reason, we believe it is important for patients to consent to receiving these services. Therefore, we specifically solicited comment on whether we should require, for example, verbal consent that will be noted in the medical record for each service.
We also proposed that this service can only be furnished for established patients because we believe that the practitioner needs to have an existing relationship with the patient, and therefore, basic knowledge of the patient's medical condition and needs, in order to perform this service.
We did not propose to apply a frequency limit on the use of this code by the same practitioner with the same patient, but we want to ensure that this code is appropriately utilized for circumstances when a patient needs a brief non-face-to-face check-in to assess whether an office visit is necessary. We solicited comment on whether it would be clinically appropriate to apply a frequency limitation on the use of this code by the same practitioner with the same patient, and on what would be a reasonable frequency limitation.
We also solicited comment on the timeframes under which this service would be separately billable compared to when it would be bundled. We believe the general construct of bundling the services that lead directly to a billable visit is important, but we are concerned that establishing strict timeframes may create unintended consequences regarding scheduling of care. For example, we do not want to bundle only the services that occur within 24 hours of a visit only to see a significant number of visits occurring at 25 hours after the initial service. In order to mitigate these incentives, we solicited comment on whether we should consider broadening the window of time and/or circumstances in which this service should be bundled into the subsequent related visit. We noted that these services, like any other physicians' service, must be medically reasonable and necessary in order to be paid by Medicare.
We solicited comment on how clinicians could best document the medical necessity of this service, consistent with documentation requirements necessary to demonstrate the medical necessity of any service under the PFS.
In summary, we are creating coding and finalizing our proposal to make separate payment for brief communication technology-based services. The code will be described as G2012 (Brief communication technology-based service,
We are finalizing that if the service originates from a related E/M service provided within the previous 7 days by the same physician or other qualified health care professional, that this service would be considered bundled into that previous E/M service and would not be separately billable. In instances when the service leads to an E/M service with the same physician or other qualified health care professional, we are finalizing that this service would be considered bundled into the pre- or post-visit time of the associated E/M service, and therefore, would not be separately billable. We plan to monitor this service with the intention of determining whether changes are necessary to the timeframes under which this service would be separately billable compared to when it would be bundled. We would consider any such changes in future rulemaking.
We are finalizing requiring verbal consent from beneficiaries that is noted in the medical record for each service. We are not implementing a frequency limitation for CY 2019, however, we plan to monitor utilization with the intention of determining whether such a limitation is warranted. In that case, we would consider that for future rulemaking.
We are finalizing the valuation for HCPCS code G2012 as proposed. We will monitor the utilization of this code and consider any potential adjustments to billing rules or valuation for this service through future rulemaking. We note that cost sharing for these services will apply.
For details related to developing utilization estimates for this service, see section VII. of this final rule, Regulatory Impact Analysis. For additional details related to valuation of this service, see section II.H. of this final rule, Valuation of Specific Codes.
Stakeholders have requested that CMS make separate Medicare payment when a physician uses recorded video and/or images captured by a patient in order to evaluate a patient's condition. These services involve what is referred to under section 1834(m) of the Act as “store-and-forward” communication technology that provides for the “asynchronous transmission of health care information.” We noted in the proposed rule that we believe these services involve pre-recorded patient-generated still or video images. Other types of patient-generated information, such as information from heart rate monitors or other devices that collect patient health marker data, could potentially be reported with CPT codes that describe remote patient monitoring (83 FR 35724). Under section 1834(m) of
Also like the virtual check-in service we are finalizing as described previously, this service would be used to determine whether or not an office visit or other service is warranted. When the remote evaluation of pre-recorded patient-submitted images and/or video results in an in-person E/M office visit with the same physician or qualified health care professional, we proposed that this remote service will be considered bundled into that office visit and therefore not be separately billable. We further proposed that in instances when the remote service originates from a related E/M service provided within the previous 7 days by the same physician or qualified health care professional that this service will be considered bundled into that previous E/M service and not be separately billable. In summary, we proposed this service to be a stand-alone service that could be separately billed to the extent that there is no resulting E/M office visit and there is no related E/M office visit within the previous 7 days of the remote service being furnished. We believe the coding and separate payment for this service is consistent with the progression of technology and its impact on the practice of medicine in recent years, and would result in increased access to services for Medicare beneficiaries. We note that in the proposed rule we referred to this service as HCPCS code GRAS1, which was a placeholder code. The code for this service is G2010 (Remote evaluation of recorded video and/or images submitted by an established patient (
The following discussion summarizes particular definitions and billing rules we proposed for this service and the more detailed comments we received regarding these aspects of the proposal. Our responses below include information regarding the service definitions and billing requirements applicable for 2019. We additionally address comments we received regarding whether these services should be limited to established patients; or whether there are certain cases, like dermatological or ophthalmological services, where it might be appropriate for a new patient to receive these services.
We appreciate commenters' concerns regarding the potential for overutilization of these services. We plan to monitor utilization. We note that, like all other physicians' services billed under the PFS, each of these services must be medically reasonable and necessary to be paid by Medicare.
We acknowledge that verbal consent could be obtained using more than one communication modality, especially since this service is initiated by the patient and involves submission of an image or video. Therefore, we do not intend to include the word “verbal” in the descriptor for the code that describes this services, since “verbal” could imply written or electronic consent.
In summary, we are creating coding and finalizing our proposal to make separate payment for remote evaluation of recorded video and/or images submitted by the patient. The code will be described as G2010 (Remote evaluation of recorded video and/or images submitted by an established patient (
When the review of the patient-submitted image and/or video results in an in-person E/M office visit with the same physician or qualified health care professional, we are finalizing that this remote service will be considered bundled into that office visit and therefore will not be separately billable. We are further finalizing that in instances when the remote service originates from a related E/M service provided within the previous 7 days by the same physician or qualified health care professional that this service will be considered bundled into that previous E/M service and also will not be separately billable.
We are finalizing requiring beneficiary consent that could be verbal or written, including electronic confirmation that is noted in the medical record for each billed service for HCPCS code G2010.
We are finalizing the valuation for HCPCS code G2010 as proposed. We will monitor utilization of this code and consider any potential adjustments to billing rules or valuation of this service through future rulemaking. We note that cost sharing for these services will apply.
For details related to our utilization estimates for this service, see section VII. of this final rule, Regulatory Impact Analysis. For further discussion related to valuation of this service, please see the section II.H. of this final rule, Valuation of Specific Codes.
As part of our standard rulemaking process, we received recommendations from the RUC to assist in establishing values for six CPT codes that describe interprofessional consultations. In 2013, CMS received recommendations from the RUC for CPT codes 99446 (Interprofessional telephone/internet assessment and management service provided by a consultative physician including a verbal and written report to the patient's treating/requesting physician or other qualified health care professional; 5-10 minutes of medical consultative discussion and review), 99447 (Interprofessional telephone/internet assessment and management service provided by a consultative physician including a verbal and written report to the patient's treating/requesting physician or other qualified health care professional; 11-20 minutes of medical consultative discussion and review), 99448 (Interprofessional telephone/internet assessment and management service provided by a consultative physician including a verbal and written report to the patient's treating/requesting physician or other qualified health care professional; 21-30 minutes of medical consultative discussion and review), and 99449 (Interprofessional telephone/internet assessment and management service provided by a consultative physician including a verbal and written report to the patient's treating/requesting physician or other qualified health care professional; 31 minutes or more of medical consultative discussion and review). CMS declined to adopt these codes for separate payment, stating in the CY 2014 PFS final rule with comment period that these kinds of services are considered bundled (78 FR 74343). For CY 2019, the CPT Editorial Panel created two new codes to describe additional consultative services, including a code describing the work of the treating physician when initiating a consult, and the RUC recommended valuation for new codes, CPT codes 99452 (Interprofessional telephone/internet/electronic health record referral service(s) provided by a treating/requesting physician or qualified health care professional, 30 minutes) and 99451 (Interprofessional telephone/internet/electronic health record assessment and management service provided by a consultative physician including a written report to the patient's treating/requesting physician or other qualified health care professional, 5 or more minutes of medical consultative time). The RUC also reaffirmed their prior recommendations for the existing CPT codes. The six codes describe assessment and management services conducted through telephone, internet, or electronic health record consultations furnished when a patient's treating physician or other qualified healthcare professional requests the opinion and/or treatment advice of a consulting physician or qualified healthcare professional with specific specialty expertise to assist with the diagnosis and/or management of the patient's problem without the need for the patient's face-to-face contact with the consulting physician or qualified healthcare professional. Currently, the resource costs associated with seeking or providing such a consultation are considered bundled, which in practical terms means that specialist input is often sought through scheduling a separate visit for the patient when a phone or internet-based interaction between the treating practitioner and the consulting practitioner would have been sufficient. We believe that proposing payment for these interprofessional consultations performed via communications technology such as telephone or internet is consistent with our ongoing efforts to recognize and reflect medical practice trends in primary care and patient-centered care management within the PFS.
Beginning in the CY 2012 PFS proposed rule (76 FR 42793), we have recognized the changing focus in medical practice toward managing patients' chronic conditions, many of which particularly challenge the Medicare population, including heart disease, diabetes, respiratory disease, breast cancer, allergies, Alzheimer's disease, and factors associated with obesity. We have expressed concerns that the current E/M coding does not adequately reflect the changes that have occurred in medical practice, and the activities and resource costs associated with the treatment of these complex patients in the primary care setting. In the years since 2012, we have acknowledged the shift in medical practice away from an episodic treatment-based approach to one that involves comprehensive patient-centered care management, and have taken steps through rulemaking to better reflect that approach in payment under the PFS. In CY 2013, we established new codes to pay separately for transitional care management (TCM) services. Next, we finalized new coding and separate payment beginning in CY 2015 for chronic care management (CCM) services provided by clinical staff (81 FR 80226). In the CY 2017 PFS final rule, we established separate payment for complex CCM services, an add-on code to the visit during which CCM is initiated to reflect the work of the billing practitioner in assessing the beneficiary and establishing the CCM care plan, and established separate payment for Behavioral Health Integration (BHI) services (81 FR 80226 through 80227).
As part of this shift in medical practice, and with the proliferation of team-based approaches to care that are often facilitated by electronic medical record technology, we believe that making separate payment for interprofessional consultations undertaken for the benefit of treating a patient will contribute to payment accuracy for primary care and care management services. We proposed
Although we proposed to make separate payment for these services because we believe they describe resource costs directly associated with seeking a consultation for the benefit of the beneficiary, we do have concerns about how these services can be distinguished from activities undertaken for the benefit of the practitioner, such as information shared as a professional courtesy or as continuing education. We do not believe that those examples will constitute a service directly attributable to a single Medicare beneficiary, and therefore neither the Medicare program nor the beneficiary should be responsible for those costs. We therefore solicited comment on our assumption that these are separately identifiable services, and the extent to which they can be distinguished from similar services that are nonetheless primarily for the benefit of the practitioner. We noted that there are program integrity concerns around making separate payment for these interprofessional consultation services, including around CMS's or its contractors' ability to evaluate whether an interprofessional consultation is reasonable and necessary under the particular circumstances. As the beneficiary would be liable for any cost sharing associated with these services, we also sought comment on the necessity of requiring patient consent for these, and whether than consent should be written or verbal. We solicited comment on how best to minimize potential program integrity issues, and noted we were particularly interested in information on whether these types of services are paid separately by private payers and if so, what controls or limitations private payers have put in place to ensure these services are billed appropriately.
The following is a summary of the comments we received regarding how best to minimize potential program integrity issues.
Many commenters provided helpful responses to CMS' request for information on how to minimize program integrity concerns for these services. A few commenters provided suggestions as to how CMS could verify the medical necessity of the consultation, including verifying that the treating and consulting physician were of different medical specialties, requiring patient identifiers and documentation of how the interaction improved patient care, defining a time period under which an E/M visit and an Interprofessional Consultation cannot both be billed for the same diagnosis, and creating frequency limitations on billing. Others suggested that the treating physician must document that they acted on the recommendation of the consulting physician prior to billing for CPT code 99452. Commenters had a number of suggestions for items that CMS should require, including that Interprofessional Consultations should consist of focused questions that are answerable solely from information in the EMR; that they be answered in 3 business days; and that the consulting physician should restate the question in their response, provide recommendations for evaluation, management, and/or ongoing monitoring, provide a rationale for recommendations, and provide recommendations for contingencies. Other commenters suggested that CMS could make separate payment contingent upon whether the underlying condition was urgent or related to critical care and that the consultation helped avoid transfer or interruption of care or that internal expertise was sought and was not available. Many commenters also encouraged CMS to avoid imposing overly restrictive documentation requirements. One commenter stated that, due to potential program integrity concerns, these services should be subject to the Medicare telehealth restrictions on beneficiary location and site of service. Another commenter recommended that CMS delay implementation until the program integrity concerns have been addressed. Other commenters encouraged CMS to monitor utilization for abuse.
Additionally, since these codes describe services that are furnished without the beneficiary being present, we proposed to require the treating practitioner to obtain verbal beneficiary consent in advance of these services, which would be documented by the treating practitioner in the patient's medical record, similar to the conditions of payment associated with separately billable care management services under the PFS. Obtaining advance beneficiary consent includes ensuring that the patient is aware of applicable cost sharing.
The following is a summary of the comments we received regarding whether to require the treating practitioner to obtain verbal beneficiary consent in advance of these services, which would be documented by the treating practitioner in the medical record similar to the conditions of payment associated with the care management services under the PFS, as well as comments on other aspects of this proposal.
We are finalizing that the patient's verbal consent is required, and that consent must be noted in the medical record for each service, consistent with the policy we are finalizing for the brief communication technology-based services (HCPCS code G2012) as noted above, as well as with the patient consent policies in place for care management services, under the PFS.
In summary, we are finalizing separate payment for CPT codes 99451, 99452, 99446, 99447, 99448, and 99449 describing Interprofessional consultations. We are finalizing a policy to require the patient's verbal consent that is noted in the medical record for each interprofessional consultation service. We note that cost sharing will apply for these services. These interprofessional services may be billed only by practitioners that can bill Medicare independently for E/M services.
For further discussion related to the valuation of these services, please see section II.H. of this final rule, Valuation of Specific Codes.
As discussed in this rule and in prior rulemaking, several conditions must be met for Medicare to make payment for telehealth services under the PFS. For further details, see the full discussion of the scope of Medicare telehealth services in the CY 2018 PFS final rule (82 FR 53006).
In the CY 2003 PFS final rule with comment period (67 FR 79988), we established a process for adding services to or deleting services from the list of Medicare telehealth services in accordance with section 1834(m)(4)(F)(ii) of the Act. This process provides the public with an ongoing opportunity to submit requests for adding services, which are then reviewed by us. Under this process, we assign any submitted request to add to the list of telehealth services to one of the following two categories:
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Some examples of clinical benefit include the following:
• Ability to diagnose a medical condition in a patient population without access to clinically appropriate in-person diagnostic services.
• Treatment option for a patient population without access to clinically appropriate in-person treatment options.
• Reduced rate of complications.
• Decreased rate of subsequent diagnostic or therapeutic interventions (for example, due to reduced rate of recurrence of the disease process).
• Decreased number of future hospitalizations or physician visits.
• More rapid beneficial resolution of the disease process treatment.
• Decreased pain, bleeding, or other quantifiable symptom.
• Reduced recovery time.
The list of telehealth services, including the proposed additions described later in this section, is included in the Downloads section to this proposed rule at
Historically, requests to add services to the list of Medicare telehealth services had to be submitted and received no later than December 31 of each calendar year to be considered for the next rulemaking cycle. However, for CY 2019 and onward, we intend to accept requests through February 10, consistent with the deadline for our receipt of code valuation recommendations from the RUC. To be
Under our current policy, we add services to the telehealth list on a Category 1 basis when we determine that they are similar to services on the existing telehealth list for the roles of, and interactions among, the beneficiary, physician (or other practitioner) at the distant site and, if necessary, the telepresenter. As we stated in the CY 2012 PFS final rule with comment period (76 FR 73098), we believe that the Category 1 criteria not only streamline our review process for publicly requested services that fall into this category, but also expedite our ability to identify codes for the telehealth list that resemble those services already on this list.
We received several requests in CY 2017 to add various services as Medicare telehealth services effective for CY 2019. The following presents a discussion of these requests, and our proposals for additions to the CY 2019 telehealth list. Of the requests received, we found that two services were sufficiently similar to services currently on the telehealth list to be added on a Category 1 basis. Therefore, we proposed to add the following services to the telehealth list on a Category 1 basis for CY 2019:
• HCPCS codes G0513 and G0514 (Prolonged preventive service(s) (beyond the typical service time of the primary procedure), in the office or other outpatient setting requiring direct patient contact beyond the usual service; first 30 minutes (list separately in addition to code for preventive service) and (Prolonged preventive service(s) (beyond the typical service time of the primary procedure), in the office or other outpatient setting requiring direct patient contact beyond the usual service; each additional 30 minutes (list separately in addition to code G0513 for additional 30 minutes of preventive service).
We found that the services described by HCPCS codes G0513 and G0514 are sufficiently similar to office visits currently on the telehealth list. We believe that all the components of this service can be furnished via interactive telecommunications technology. Additionally, we believe that adding these services to the telehealth list will make it administratively easier for practitioners who report these services in connection with a preventive service that is furnished via telehealth, as both the base code and the add-on code would be reported with the telehealth place of service.
We also received requests to add services to the telehealth list that do not meet our criteria for Medicare telehealth services. We did not propose to add to the Medicare telehealth services list the following procedures for chronic care remote physiologic monitoring, interprofessional internet consultation, and initial hospital care; or to change the requirements for subsequent hospital care or subsequent nursing facility care, for the reasons noted in the paragraphs that follow.
• CPT code 99453 (Remote monitoring of physiologic parameter(s) (
• CPT code 99454 (Remote monitoring of physiologic parameter(s) (
• CPT code 99457 (Remote physiologic monitoring treatment management services, 20 minutes or more of clinical staff/physician/other qualified healthcare professional time in a calendar month requiring interactive communication with the patient/caregiver during the month).
In the CY 2016 PFS final rule with comment period (80 FR 71064), we responded to a request to add CPT code 99490 (Chronic care management services, at least 20 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month, with the following required elements: Multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient; chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline; comprehensive care plan established, implemented, revised, or monitored) to the Medicare telehealth list. We discussed that the services described by CPT code 99490 can be furnished without the beneficiary's face-to-face presence and using any number of non-face-to-face means of communication. We stated that it was therefore unnecessary to add that service to the list of Medicare telehealth services. Similarly, CPT codes 99453, 99454, and 99457 describe services that are inherently non face-to-face. As discussed in section II.H. of this final rule, Valuation of Specific Codes, we instead proposed to adopt CPT codes 99453, 99454, and 99457 for payment under the PFS. Because these codes describe services that are inherently non face-to-face, we do not consider them Medicare telehealth services under section 1834(m) of the Act; therefore, we did not propose to add them to the list of Medicare telehealth services.
• CPT code 99452 (Interprofessional telephone/internet/electronic health record referral service(s) provided by a treating/requesting physician or qualified health care professional, 30 minutes).
• CPT code 99451 (Interprofessional telephone/internet/electronic health record assessment and management service provided by a consultative physician including a written report to the patient's treating/requesting physician or other qualified health care professional, 5 or more minutes of medical consultative time).
As discussed in section II.H. of this final rule, Valuation of Specific Codes, we proposed to adopt CPT codes 99452 and 99451 for payment under the PFS as these are distinct services furnished via communication technology. Because these codes describe services that are inherently non face-to-face, we do not consider them as Medicare telehealth services under section 1834(m) of the Act; therefore we did not propose to add them to the list of Medicare telehealth services for CY 2019.
• CPT code 99221 (Initial hospital care, per day, for the evaluation and
• CPT code 99222 (Initial hospital care, per day, for the evaluation and management of a patient, which requires these 3 key components: A comprehensive history; A comprehensive examination; and Medical decision making of moderate complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the problem(s) requiring admission are of moderate severity.)
• CPT code 99223 (Initial hospital care, per day, for the evaluation and management of a patient, which requires these 3 key components: A comprehensive history; A comprehensive examination; and Medical decision making of high complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the problem(s) requiring admission are of high severity.)
We have previously considered requests to add these codes to the telehealth list. As we stated in the CY 2011 PFS final rule with comment period (75 FR 73315), while initial inpatient consultation services are currently on the list of approved telehealth services, there are no services on the current list of telehealth services that resemble initial hospital care for an acutely ill patient by the admitting practitioner who has ongoing responsibility for the patient's treatment during the course of the hospital stay. Therefore, consistent with prior rulemaking, we did not propose that initial hospital care services be added to the Medicare telehealth services list on a category 1 basis.
The initial hospital care codes describe the first visit of the hospitalized patient by the admitting practitioner who may or may not have seen the patient in the decision-making phase regarding hospitalization. Based on the description of the services for these codes, we believed it is critical that the initial hospital visit by the admitting practitioner be conducted in person to ensure that the practitioner with ongoing treatment responsibility comprehensively assesses the patient's condition upon admission to the hospital through a thorough in-person examination. Additionally, the requester submitted no additional research or evidence that the use of a telecommunications system to furnish the service produces demonstrated clinical benefit to the patient; therefore, we also did not propose adding initial hospital care services to the Medicare telehealth services list on a Category 2 basis.
We noted that Medicare beneficiaries who are being treated in the hospital setting can receive reasonable and necessary E/M services using other HCPCS codes that are currently on the Medicare telehealth list, including those for subsequent hospital care, initial and follow-up telehealth inpatient and emergency department consultations, as well as initial and follow-up critical care telehealth consultations.
Therefore, we did not propose to add the initial hospital care services to the list of Medicare telehealth services for CY 2019.
• CPT code 99231 (Subsequent hospital care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key components: A problem focused interval history; A problem focused examination; Medical decision making that is straightforward or of low complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the patient is stable, recovering or improving. Typically, 15 minutes are spent at the bedside and on the patient's hospital floor or unit.).
• CPT code 99232 (Subsequent hospital care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key components: An expanded problem focused interval history; an expanded problem focused examination; medical decision making of moderate complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the patient is responding inadequately to therapy or has developed a minor complication. Typically, 25 minutes are spent at the bedside and on the patient's hospital floor or unit.).
• CPT code 99233 (Subsequent hospital care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key components: A detailed interval history; a detailed examination; Medical decision making of high complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the patient is unstable or has developed a significant complication or a significant new problem. Typically, 35 minutes are spent at the bedside and on the patient's hospital floor or unit.).
CPT codes 99231-99233 are currently on the list of Medicare telehealth services, but can only be billed via telehealth once every 3 days. The requester requested that we remove the frequency limitation. We stated in the CY 2011 PFS final rule with comment period (75 FR 73316) that, although we still believed the potential acuity of hospital inpatients is greater than those patients likely to receive Medicare telehealth services that were on the list at that time, we also believed that it would be appropriate to permit some subsequent hospital care services to be furnished through telehealth in order to ensure that hospitalized patients have frequent encounters with their admitting practitioner. We also noted that we continue to believe that the majority of these visits should be in-person to facilitate the comprehensive, coordinated, and personal care that medically volatile, acutely ill patients require on an ongoing basis. Because of our concerns regarding the potential acuity of hospital inpatients, we finalized the addition of CPT codes 99231-99233 to the list of Medicare telehealth services, but limited the provision of these subsequent hospital care services through telehealth to once every 3 days. We continue to believe that admitting practitioners should continue to make appropriate in-person visits to all patients who need such care during their hospitalization. Our concerns and position on the provision of subsequent hospital care services via telehealth have not changed. Therefore, we did not propose to remove the frequency limitation on these codes.
• CPT code 99307 (Subsequent nursing facility care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key components: A problem focused interval history; A problem focused examination; Straightforward medical decision making. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the patient is stable, recovering, or improving. Typically, 10 minutes are spent at the bedside and on the patient's facility floor or unit.).
• CPT code 99308 (Subsequent nursing facility care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key components: An expanded problem focused interval history; an expanded problem focused examination; Medical decision making of low complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the patient is responding inadequately to therapy or has developed a minor complication. Typically, 15 minutes are spent at the bedside and on the patient's facility floor or unit.).
• CPT code 99309 (Subsequent nursing facility care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key components: A detailed interval history; a detailed examination; Medical decision making of moderate complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the patient has developed a significant complication or a significant new problem. Typically, 25 minutes are spent at the bedside and on the patient's facility floor or unit.).
• CPT code 99310 (Subsequent nursing facility care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key components: A comprehensive interval history; a comprehensive examination; Medical decision making of high complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. The patient may be unstable or may have developed a significant new problem requiring immediate physician attention. Typically, 35 minutes are spent at the bedside and on the patient's facility floor or unit.).
CPT codes 99307-99310 are currently on the list of Medicare telehealth services, but can only be billed via telehealth once every 30 days. The requester requested that we remove the frequency limitation when these services are provided for psychiatric care. We stated in the CY 2011 PFS final rule with comment period (75 FR 73317) that we believed it would be appropriate to permit some subsequent nursing facility care services to be furnished through telehealth to ensure that complex nursing facility patients have frequent encounters with their admitting practitioner, but because of our concerns regarding the potential acuity and complexity of SNF inpatients, we limited the provision of subsequent nursing facility care services furnished through telehealth to once every 30 days. Since these codes are used to report care for patients with a variety of diagnoses, including psychiatric diagnoses, we do not think it would be appropriate to remove the frequency limitation only for certain diagnoses. The services described by these CPT codes are essentially the same service, regardless of the patient's diagnosis. We also continue to have concerns regarding the potential acuity and complexity of SNF inpatients, and therefore, we did not propose to remove the frequency limitation for subsequent nursing facility care services in CY 2019.
In summary, we proposed to add the following codes to the list of Medicare telehealth services beginning in CY 2019 on a category 1 basis:
• HCPCS code G0513 (Prolonged preventive service(s) (beyond the typical service time of the primary procedure), in the office or other outpatient setting requiring direct patient contact beyond the usual service; first 30 minutes (list separately in addition to code for preventive service).
• HCPCS code G0514 (Prolonged preventive service(s) (beyond the typical service time of the primary procedure), in the office or other outpatient setting requiring direct patient contact beyond the usual service; each additional 30 minutes (list separately in addition to code G0513 for additional 30 minutes of preventive service).
Section 50302 of the BBA of 2018 amended sections 1881(b)(3) and 1834(m) of the Act to allow an individual determined to have end-stage renal disease receiving home dialysis to choose to receive certain monthly end-stage renal disease-related (ESRD-related) clinical assessments via telehealth on or after January 1, 2019.
As added by section 50302(b)(1) of the BBA of 2018, subclauses (IX) and (X) of section 1834(m)(4)(C)(ii) of the Act include a renal dialysis facility and the home of an individual as telehealth originating sites but only for the purposes of the monthly ESRD-related clinical assessments furnished through telehealth provided under section 1881(b)(3)(B) of the Act. Section 50302(b)(1) of the BBA of 2018, also added a new section 1834(m)(5) of the Act which provides that the geographic requirements for telehealth services under section 1834(m)(4)(C)(i) of the Act do not apply to telehealth services furnished on or after January 1, 2019 for purposes of the monthly ESRD-related clinical assessments where the originating site is a hospital-based or critical access hospital-based renal dialysis center, a renal dialysis facility, or the home of an individual. Section 50302(b)(2) of the BBA of 2018 amended section 1834(m)(2)(B)(ii) of the Act to require that no originating site facility fee is to be paid if the home of the individual is the originating site.
Our current regulation at § 410.78 specifies the conditions that must be met in order for Medicare Part B to pay for covered telehealth services included on the telehealth list when furnished by an interactive telecommunications system. In accordance with the new subclauses (IX) and (X) of section 1834(m)(4)(C)(ii) of the Act, we proposed to revise our regulation at § 410.78(b)(3) to add a renal dialysis facility and the home of an individual as Medicare telehealth originating sites, but only for purposes of the home dialysis monthly ESRD-related clinical assessment in section 1881(b)(3)(B) of the Act. We proposed to amend § 414.65(b)(3) to reflect the requirement in section 1834(m)(2)(B)(ii) of the Act that there is no originating site facility fee paid when the originating site for these services is the patient's home. Additionally, we proposed to add new § 410.78(b)(4)(iv)(A), to reflect the provision in section 1834(m)(5) of the Act, added by section 50302 of the BBA of 2018, specifying that the geographic requirements described in section 1834(m)(4)(C)(i) of the Act do not apply with respect to telehealth services furnished on or after January 1, 2019, in originating sites that are hospital-based or critical access hospital-based renal dialysis centers, renal dialysis facilities, or the patient's home, respectively under sections 1834(m)(4)(C)(ii)(VI), (IX) and (X) of the Act, for purposes of section 1881(b)(3)(B) of the Act.
Commenters supported our proposals to revise the regulation text at §§ 410.78 and 414.65 to implement the requirements of section 50302 of the BBA of 2018 for expanding access to home dialysis therapy through telehealth. We are finalizing these regulation text changes as proposed.
Section 50325 of the BBA of 2018 amended section 1834(m) of the Act by adding a new paragraph (6) that provides special rules for telehealth services furnished on or after January 1, 2019, for purposes of diagnosis, evaluation, or treatment of symptoms of an acute stroke (acute stroke telehealth services), as determined by the Secretary. Specifically, section 1834(m)(6)(A) of the Act removes the restrictions on the geographic locations and the types of originating sites where acute stroke telehealth services can be furnished. Section 1834(m)(6)(B) of the Act specifies that acute stroke telehealth services can be furnished in any hospital, critical access hospital, mobile stroke units (as defined by the Secretary), or any other site determined appropriate by the Secretary, in addition to the current eligible telehealth originating sites. Section 1834(m)(6)(C) of the Act limits payment of an originating site facility fee to acute stroke telehealth services furnished in sites that meet the usual telehealth restrictions under section 1834(m)(4)(C) of the Act.
To implement these requirements, we proposed to create a new modifier that would be used to identify acute stroke telehealth services. The practitioner and, as appropriate, the originating site, would append this modifier when clinically appropriate to the HCPCS code when billing for an acute stroke telehealth service or an originating site facility fee, respectively. We note that section 50325 of the BBA of 2018 did not amend section 1834(m)(4)(F) of the Act, which limits the scope of telehealth services to those on the Medicare telehealth list. Practitioners would be responsible for assessing whether it would be clinically appropriate to use this modifier with codes from the Medicare telehealth list. By billing with this modifier, practitioners would be indicating that the codes billed were used to furnish telehealth services for diagnosis, evaluation, or treatment of symptoms of an acute stroke. We believe that the adoption of a service level modifier is the least administratively burdensome means of implementing this provision for practitioners, while also allowing CMS to easily track and analyze utilization of these services.
In accordance with section 1834(m)(6)(B) of the Act, as added by section 50325 of the BBA of 2018, we also proposed to revise § 410.78(b)(3) to add mobile stroke unit as a permissible originating site for acute stroke telehealth services. We proposed to define a mobile stroke unit as a mobile unit that furnishes services to diagnose, evaluate, and/or treat symptoms of an acute stroke and solicited comment on this definition, as well as additional information on how these units are used in current medical practice. We therefore proposed that mobile stroke units and the current eligible telehealth originating sites, which include hospitals and critical access hospitals as specified in section 1834(m)(6)(B) of the Act, but excluding renal dialysis facilities and patient homes because they are only allowable originating sites for purposes of home dialysis monthly ESRD-related clinical assessments in section 1881(b)(3)(B) of the Act, would be permissible originating sites for acute stroke telehealth services.
We also solicited comment on other possible appropriate originating sites for telehealth services furnished for the diagnosis, evaluation, or treatment of symptoms of an acute stroke. Any additional sites would be adopted through future rulemaking. As required under section 1834(m)(6)(C) of the Act, the originating site facility fee would not apply in instances where the originating site does not meet the originating site type and geographic requirements under section 1834(m)(4)(C) of the Act. Additionally, we proposed to add § 410.78 (b)(4)(iv)(B) to specify that the requirements in section 1834(m)(4)(C) of the Act do not apply with respect to telehealth services furnished on or after January 1, 2019, for purposes of diagnosis, evaluation, or treatment of symptoms of an acute stroke.
In summary, we are finalizing a new modifier that will be used to identify acute stroke telehealth services. The practitioner and, as appropriate, the originating site, will append this modifier to the HCPCS code as clinically appropriate when billing for an acute stroke telehealth service or an originating site facility fee, respectively. We are finalizing the regulation text changes at §§ 410.78 and 414.65 as proposed to implement the requirements of section 50325 of the BBA of 2018 for acute stroke telehealth services. Mobile stroke units, with the definition as proposed, and the current eligible telehealth originating sites, which include hospitals and critical access hospitals, but exclude renal dialysis facilities and patient homes because they are originating sites only for purposes of home dialysis monthly ESRD-related clinical assessments in section 1881(b)(3)(B) of the Act, will be permissible originating sites for acute stroke telehealth services.
Section 2001(a) of the SUPPORT for Patients and Communities Act (Pub. L. 115-271, October 24, 2018) (the SUPPORT Act) makes several revisions to section 1834(m) of the Act. First, it removes the originating site geographic requirements under section 1834(m)(4)(C)(i) for telehealth services furnished on or after July 1, 2019 for the purpose of treating individuals diagnosed with a substance use disorder or a co-occurring mental health disorder, as determined by the Secretary, at an originating site described in section 1834(m)(4)(C)(ii) of the Act, other than an originating site described in subclause (IX) of section 1834(m)(4)(C)(ii) of the Act. The site described in subclause (IX) of section 1834(m)(4)(C)(ii) of the Act is a renal dialysis facility, which is only an allowable originating site for purposes of home dialysis monthly ESRD-related clinical assessments in section 1881(b)(3)(B) of the Act. It also adds the home of an individual as a permissible originating site for these telehealth services. Section 2001(a) of the SUPPORT Act for Patients and Communities Act additionally amends section 1834(m) of the Act to require that no originating site facility fee will be paid in instances when the individual's home is the originating site. Section 2001(b) of the SUPPORT for Patients and Communities Act grants the Secretary specific authority to implement the amendments made by section 2001(a) through an interim final rule.
Under the authority of section 2001(b) of the SUPPORT for Patients and Communities Act, we are issuing an interim final rule with comment period to implement the requirements of section 2001(a) of the SUPPORT for Patients and Communities Act. In accordance with section 1834(m)(2)(B)(ii)(X) of the Act, as amended by section 2001(a) of the SUPPORT for Patients and Communities Act, we are revising § 410.78(b)(3) on an interim final basis, by adding § 410.78(b)(3)(xii), which adds the home of an individual as a permissible originating site for telehealth services furnished on or after July 1, 2019 to individuals with a substance use disorder diagnosis for purposes of treatment of a substance use disorder or a co-occurring mental health disorder. We are amending § 414.65(b)(3) on an interim final basis to reflect the requirement in section 1834(m)(2)(B)(ii) of the Act that there is no originating site facility fee paid when the originating site for these services is the individual's home. Additionally, we are adding § 410.78(b)(4)(iv)(C) on an interim final basis to specify that the geographic requirements in section 1834(m)(4)(C)(i) of the Act do not apply for telehealth services furnished on or after July 1, 2019, to individuals with a substance use disorder diagnosis for purposes of treatment of a substance use disorder or a co-occurring mental health disorder at an originating site other than a renal dialysis facility.
We note that section 2001 of the SUPPORT for Patients and Communities Act did not amend section 1834(m)(4)(F) of the Act, which limits the scope of telehealth services to those on the Medicare telehealth list. Practitioners would be responsible for assessing whether individuals have a substance use disorder diagnosis and whether it would be clinically appropriate to furnish telehealth services for the treatment of the individual's substance use disorder or a co-occurring mental health disorder. By billing codes on the Medicare telehealth list with the telehealth place of service code, practitioners would be indicating that the codes billed were used to furnish telehealth services to individuals with a substance use disorder diagnosis for the purpose of treating the substance use disorder or a co-occurring mental health disorder. We note that we may issue additional subregulatory guidance in the future for billing these telehealth services.
We note that there is a 60-day period following publication of this interim final rule for the public to comment on these interim final amendments to our regulations. We invite public comment on our policies to implement section 2001 of the SUPPORT for Patients and Communities Act.
Section 2005 of the SUPPORT Act establishes a new Medicare benefit category for opioid use disorder treatment services furnished by OTPs under Medicare Part B, beginning on or after January 1, 2020. This provision requires that opioid use disorder treatment services would include FDA-approved opioid agonist and antagonist treatment medications, the dispensing and administration of such medications (if applicable), substance use disorder counseling, individual and group therapy, toxicology testing, and other services determined appropriate (but in no event to include meals and transportation). The provision defines OTPs as those that enroll in Medicare and are certified by the Substance Abuse and Mental Health Services Administration (SAMHSA), accredited by a SAMHSA-approved entity, and meeting additional conditions as the Secretary finds necessary to ensure the health and safety of individuals being furnished services under these programs and the effective and efficient furnishing of such services.
We note that there is a 60-day period for the public to comment on the provisions of the interim final rule described previously to implement section 2001 of the SUPPORT for Patients and Communities Act. During that same comment period, we are requesting information regarding services furnished by OTPs, payments for these services, and additional conditions for Medicare participation for OTPs that stakeholders believe may be useful for us to consider for future rulemaking to implement this new Medicare benefit category.
In the CY 2015 PFS final rule with comment period, we finalized a proposal to change our regulation at § 410.78(b) by deleting the description of the individual services for which Medicare payment can be made when furnished via telehealth, noting that we revised § 410.78(f) to indicate that a list of Medicare telehealth codes and descriptors is available on the CMS website (79 FR 67602). In accordance with that change, we proposed a technical revision to also delete the description of individual services and exceptions for Medicare payment for telehealth services in § 414.65, by amending § 414.65(a) to note that Medicare payment for telehealth services is addressed in § 410.78 and by deleting § 414.65(a)(1).
There is an evidence base that suggests that routine counseling, either associated with medication assisted treatment (MAT) or on its own, can increase the effectiveness of treatment for substance use disorders (SUDs). According to a study in the
We also believe making separate payment for a bundled episode of care for management and counseling for SUDs could be effective in preventing the need for more acute services. For example, according to the
As indicated earlier, we considered whether it would be appropriate to develop a separate bundled payment for an episode of care for treatment of SUDs. We solicited public comment on whether such a bundled episode-based payment would be beneficial to improve access, quality and efficiency for SUD treatment. Further, we solicited public comment on developing coding and payment for a bundled episode of care for treatment for SUDs that could include overall treatment management, any necessary counseling, and components of a MAT program such as treatment planning, medication management, and observation of drug dosing. Specifically, we solicited public comments related to what assumptions we might make about the typical number of counseling sessions as well as the duration of the service period, which types of practitioners could furnish these services, and what components of MAT could be included in the bundled episode of care. We were interested in stakeholder feedback regarding how to define and value this bundle and what conditions of payment should be attached. Additionally, we solicited comment on whether the concept of a global period, similar to the currently existing global periods for surgical procedures, might be applicable to treatment for SUDs.
We also solicited comment on whether the counseling portion and other MAT components could also be provided by qualified practitioners “incident to” the services of the billing physician who will administer or prescribe any necessary medications and manage the overall care, as well as supervise any other counselors participating in the treatment, similar to the structure of the Behavioral Health Integration codes which include
We note that there is a 60-day period for the public to comment on the interim final telehealth policies and revisions to our regulations we are adopting to implement statutory amendments to section 1834(m) of the Act that expand access to telehealth services used to treat substance use disorders. During that same comment period, we are requesting additional information from stakeholders and the public that we might consider for future rulemaking regarding payment structure and amounts for SUD treatment that account for ongoing treatment and wide variability in patient needs for treatment of SUDs while improving access to necessary care.
Additionally, we invited public comment and suggestions for regulatory and subregulatory changes to help prevent opioid use disorder and improve access to treatment under the Medicare program. We solicited comment on methods for identifying non-opioid alternatives for pain treatment and management, along with identifying barriers that may inhibit access to these non-opioid alternatives including barriers related to payment or coverage. Consistent with our “Patients Over Paperwork” Initiative, we were interested in suggestions to improve existing requirements to more effectively address the opioid epidemic.
Section 1834(m)(2)(B) of the Act established the Medicare telehealth originating site facility fee for telehealth services furnished from October 1, 2001 through December 31, 2002, at $20.00. For telehealth services furnished on or after January 1 of each subsequent calendar year, the telehealth originating site facility fee is increased by the percentage increase in the Medicare Economic Index (MEI) as defined in section 1842(i)(3) of the Act. The originating site facility fee for telehealth services furnished in CY 2018 is $25.76. The MEI increase for 2019 is 1.5 percent and is based on the most recent historical update of the MEI through 2018Q2 (2.0 percent), and the most recent historical multifactor productivity adjustment (MFP) through calendar year 2017 (0.5 percent). Therefore, for CY 2019, the payment amount for HCPCS code Q3014 (Telehealth originating site facility fee) is 80 percent of the lesser of the actual charge or $26.15. The Medicare telehealth originating site facility fee and the MEI increase by the applicable time period is shown in Table 10.
Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a periodic review, not less often than every 5 years, of the RVUs established under the PFS. Section 1848(c)(2)(K) of the Act requires the Secretary to periodically identify potentially misvalued services using certain criteria and to review and make appropriate adjustments to the relative values for those services. Section 1848(c)(2)(L) of the Act also requires the Secretary to develop a process to validate the RVUs of certain potentially misvalued codes under the PFS, using the same criteria used to identify potentially misvalued codes, and to make appropriate adjustments.
As discussed in section II.H. of this final rule, Valuation of Specific Codes, each year we develop appropriate adjustments to the RVUs taking into account recommendations provided by the RUC, MedPAC, and other stakeholders. For many years, the RUC has provided us with recommendations on the appropriate relative values for new, revised, and potentially misvalued PFS services. We review these recommendations on a code-by-code basis and consider these recommendations in conjunction with analyses of other data, such as claims data, to inform the decision-making process as authorized by law. We may also consider analyses of work time, work RVUs, or direct PE inputs using other data sources, such as Department of Veteran Affairs (VA), National Surgical Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons (STS), and the Merit-based Incentive Payment System (MIPS) data. In addition to considering the most recently available data, we assess the results of physician surveys and specialty recommendations submitted to us by the RUC for our review. We also consider information provided by other stakeholders. We conduct a review to assess the appropriate RVUs in the context of contemporary medical practice. We note that section
In its March 2006 Report to the Congress (
As MedPAC noted in its March 2009 Report to Congress (
• Codes that have experienced the fastest growth.
• Codes that have experienced substantial changes in PE.
• Codes that describe new technologies or services within an appropriate time period (such as 3 years) after the relative values are initially established for such codes.
• Codes which are multiple codes that are frequently billed in conjunction with furnishing a single service.
• Codes with low relative values, particularly those that are often billed multiple times for a single treatment.
• Codes that have not been subject to review since implementation of the fee schedule.
• Codes that account for the majority of spending under the PFS.
• Codes for services that have experienced a substantial change in the hospital length of stay or procedure time.
• Codes for which there may be a change in the typical site of service since the code was last valued.
• Codes for which there is a significant difference in payment for the same service between different sites of service.
• Codes for which there may be anomalies in relative values within a family of codes.
• Codes for services where there may be efficiencies when a service is furnished at the same time as other services.
• Codes with high intraservice work per unit of time.
• Codes with high PE RVUs.
• Codes with high cost supplies.
• Codes as determined appropriate by the Secretary.
Section 1848(c)(2)(K)(iii) of the Act also specifies that the Secretary may use existing processes to receive recommendations on the review and appropriate adjustment of potentially misvalued services. In addition, the Secretary may conduct surveys, other data collection activities, studies, or other analyses, as the Secretary determines to be appropriate, to facilitate the review and appropriate adjustment of potentially misvalued services. This section also authorizes the use of analytic contractors to identify and analyze potentially misvalued codes, conduct surveys or collect data, and make recommendations on the review and appropriate adjustment of potentially misvalued services. Additionally, this section provides that the Secretary may coordinate the review and adjustment of any RVU with the periodic review described in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of the Act specifies that the Secretary may make appropriate coding revisions (including using existing processes for consideration of coding changes) that may include consolidation of individual services into bundled codes for payment under the PFS.
To fulfill our statutory mandate, we have identified and reviewed numerous potentially misvalued codes as specified in section 1848(c)(2)(K)(ii) of the Act, and we intend to continue our work examining potentially misvalued codes in these areas over the upcoming years. As part of our current process, we identify potentially misvalued codes for review, and request recommendations from the RUC and other public commenters on revised work RVUs and direct PE inputs for those codes. The RUC, through its own processes, also identifies potentially misvalued codes for review. Through our public nomination process for potentially misvalued codes established in the CY 2012 PFS final rule with comment period, other individuals and stakeholder groups submit nominations for review of potentially misvalued codes as well.
Since CY 2009, as a part of the annual potentially misvalued code review and Five-Year Review process, we have reviewed approximately 1,700 potentially misvalued codes to refine work RVUs and direct PE inputs. We have assigned appropriate work RVUs and direct PE inputs for these services as a result of these reviews. A more detailed discussion of the extensive prior reviews of potentially misvalued codes is included in the CY 2012 PFS final rule with comment period (76 FR 73052 through 73055). In the CY 2012 PFS final rule with comment period (76 FR 73055 through 73958), we finalized our policy to consolidate the review of physician work and PE at the same time, and established a process for the annual public nomination of potentially misvalued services.
In the CY 2013 PFS final rule with comment period, we built upon the work we began in CY 2009 to review potentially misvalued codes that have not been reviewed since the implementation of the PFS (so-called “Harvard-valued codes”). In CY 2009 (73 FR 38589), we requested recommendations from the RUC to aid in our review of Harvard-valued codes that had not yet been reviewed, focusing first on high-volume, low intensity codes. In the fourth Five-Year Review (76 FR 32410), we requested recommendations from the RUC to aid in our review of Harvard-valued codes with annual utilization of greater than 30,000 services. In the CY 2013 PFS final rule with comment period, we identified specific Harvard-valued services with annual allowed charges that total at least $10,000,000 as
In the CY 2016 PFS final rule with comment period, we finalized for review a list of potentially misvalued services, which included eight codes in the neurostimulators analysis-programming family (CPT codes 95970-95982). We also finalized as potentially misvalued 103 codes identified through our screen of high expenditure services across specialties.
In the CY 2017 PFS final rule, we finalized for review a list of potentially misvalued services, which included eight codes in the end-stage renal disease home dialysis family (CPT codes 90963-90970). We also finalized as potentially misvalued 19 codes identified through our screen for 0-day global services that are typically billed with an evaluation and management (E/M) service with modifier 25.
In the CY 2018 PFS final rule, we finalized arthrodesis of sacroiliac joint (CPT code 27279) as potentially misvalued. Through the use of comment solicitations with regard to specific codes, we also examined the valuations of other services, in addition to, new potentially misvalued code screens (82 FR 53017 through 53018).
In the CY 2012 PFS final rule with comment period (76 FR 73058), we finalized a process for the public to nominate potentially misvalued codes. In the CY 2015 PFS final rule with comment period (79 FR 67606 through 67608), we modified this process whereby the public and stakeholders may nominate potentially misvalued codes for review by submitting the code with supporting documentation by February 10th of each year. Supporting documentation for codes nominated for the annual review of potentially misvalued codes may include the following:
• Documentation in peer reviewed medical literature or other reliable data that there have been changes in physician work due to one or more of the following: Technique, knowledge and technology, patient population, site-of-service, length of hospital stay, and work time.
• An anomalous relationship between the code being proposed for review and other codes.
• Evidence that technology has changed physician work.
• Analysis of other data on time and effort measures, such as operating room logs or national and other representative databases.
• Evidence that incorrect assumptions were made in the previous valuation of the service, such as a misleading vignette, survey, or flawed crosswalk assumptions in a previous evaluation.
• Prices for certain high cost supplies or other direct PE inputs that are used to determine PE RVUs are inaccurate and do not reflect current information.
• Analyses of work time, work RVU, or direct PE inputs using other data sources (for example, VA, NSQIP, the STS National Database, and the MIPS data).
• National surveys of work time and intensity from professional and management societies and organizations, such as hospital associations.
We evaluate the supporting documentation submitted with the nominated codes and assess whether the nominated codes appear to be potentially misvalued codes appropriate for review under the annual process. In the following year's PFS proposed rule, we publish the list of nominated codes and indicate for each nominated code whether we agree with its inclusion as a potentially misvalued code. The public has the opportunity to comment on these and all other proposed potentially misvalued codes. In that year's final rule, we finalize our list of potentially misvalued codes.
We received one submission that nominated several high-volume codes for review under the potentially misvalued code initiative. In its request, the submitter noted a systemic overvaluation of work RVUs in certain procedures and tests based “on a number of Government Accountability Office (GAO) and the Medicare Payment Advisory Commission (MedPAC) reports, media reports regarding time inflation of specific services, and the January 19, 2017 Urban Institute report for CMS.” The submitter suggested that the times CMS assumes in estimating work RVUs are inaccurate for procedures, especially due to substantial overestimates of preservice and postservice time, including follow-up inpatient and outpatient visits that do not take place. According to the submitter, the time estimates for tests and some other procedures are primarily overstated as part of the intraservice time. Furthermore, the submitter stated that previous RUC reviews of these services did not result in reductions in valuation that adequately reflected reductions in surveyed times.
Based on these analyses, the submitter requested that the codes listed in Table 11 be prioritized for review under the potentially misvalued code initiative.
Another submitter requested that CPT codes 92992 (Atrial septectomy or septostomy; transvenous method, balloon (
We received several comments with regard to the nomination of several high-volume codes for review under the potentially misvalued code initiative.
Although we appreciate the comments that were received regarding the seven high-volume codes, we believe that the nominator presented some concerns that have merit, such as the observation that in many cases time is reduced substantially but the work RVU only minimally, which results in an implied increase in the intensity of work that does not appear to be valid, and ultimately creates work intensity anomalies that are difficult to defend, and further review of these high-volume codes is the best way to determine the validity of the concerns articulated by the submitter. Therefore, we are adding CPT codes 27130, 27447, 43239, 45385, 70450, 93000, and 93306 to the list of potentially misvalued codes and anticipate reviewing recommendations from the RUC and other stakeholders. We reiterate that we do not believe that the inclusion of a code on a potentially misvalued code list necessarily means that a particular code is misvalued. Instead, the list is intended to prioritize codes to be reviewed under the misvalued code initiative.
In addition to comments on the nomination of the seven high-volume codes, we also received comments on the nomination of two contractor-priced codes for review under the potentially misvalued code initiative.
Payment for postoperative care is currently bundled within 10 or 90 days after many surgical procedures. Historically, we have not collected data on how many postoperative visits are actually performed during the global period. Section 523 of the MACRA added a new paragraph 1848(c)(8) to the Act, and section 1848(c)(8)(B) required CMS to use notice and comment rulemaking to implement a process to collect data on the number and level of postoperative visits and use these data to assess the accuracy of global surgical package valuation. In the CY 2017 PFS final rule, we adopted a policy to collect postoperative visit data. Beginning July 1, 2017, we required practitioners in groups with 10 or more practitioners in nine states (Florida, Kentucky, Louisiana, Nevada, New Jersey, North Dakota, Ohio, Oregon, and Rhode Island) to use the no-pay CPT code 99024 (Postoperative follow-up visit, normally included in the surgical package, to indicate that an E/M service was performed during a postoperative period for a reason(s) related to the original procedure) to report postoperative visits. Practitioners who only practice in groups with fewer than 10 practitioners are exempted from required reporting, but are encouraged to report if feasible. The 293 procedures for which reporting is required are those furnished by more than 100 practitioners, and either are nationally furnished more than 10,000 times annually or have more than $10 million in annual allowed charges. A list of the procedures for which reporting is required is updated annually to reflect any coding changes and is posted on the CMS website at
In these nine states, from July 1, 2017 through December 31, 2017, there were 990,581 postoperative visits reported using CPT code 99024. Of the 32,573 practitioners who furnished at least one of the 293 procedures during this period and who, based on Tax Identification Numbers in claims data, were likely to meet the practice size threshold, only 45 percent reported one or more visit using CPT code 99024 during this 6-month period. The share of practitioners who reported any CPT code 99024 claims varied by specialty. Among surgical oncology, hand surgery, and orthopedic surgeons, reporting rates were 92, 90, and 87 percent, respectively. In contrast, the reporting rate for emergency medicine physicians was 4 percent.
Among 10-day global procedures performed from July 1, 2017 through December 31, 2017, where it is possible to clearly match postoperative visits to specific procedures, only 4 percent had one or more matched visit reported with CPT code 99024. The percentage of 10-day global procedures with a matched visit reported with CPT code 99024 varied by specialty. Among procedures with 10-day global periods performed by hand surgeons, critical care, and obstetrics/gynecology, 44, 36, and 23 percent, respectively, of procedures had a matched visit reported using CPT code 99024. In contrast, less than 5 percent of 10-day global procedures performed by many other specialties had a matched visit reported using CPT code 99024. Among 90-day global procedures performed from July 1, 2017 through December 31, 2017, where it is possible to clearly match postoperative visits to specific procedures, 67 percent had one or more matched visits reported using CPT code 99024.
In the CY 2019 PFS proposed rule, we suggested one potential explanation for
We sought comment on several other issues. Given the very small number of postoperative visits reported using CPT code 99024 during 10-day global periods, we sought comment on whether or not it might be reasonable to assume that many visits included in the valuation of 10-day global packages are not being furnished, or whether there are alternative explanations for what could be a significant level of underreporting of postoperative visits. Alternatively, we sought comment on whether it is possible that some or all of the postoperative visits are occurring after the global period ends and are, therefore, reported and paid separately.
We sought comment on whether we should consider requiring use of modifiers -54 and -55 in cases where the surgeon does not expect to perform the postoperative visits, regardless of whether or not the transfer of care is formalized. We also sought comment on the best approach to 10-day global codes for which the preliminary data suggest that postoperative visits are rarely performed by the practitioner reporting the global code and whether we should consider changing the global period and reviewing the code valuation.
The following is a summary of the comments we received on collecting data on global surgery and reporting.
In accordance with § 410.32(b)(3), except as otherwise provided, all diagnostic X-ray and other diagnostic tests covered under section 1861(s)(3) of the Act and payable under the PFS must be furnished under at least a general level of physician supervision as defined in paragraph (b)(3)(i) of that regulation. In addition, some of these tests require either direct or personal supervision as defined in paragraphs (b)(3)(ii) or (iii) of § 410.32, respectively. We list the required minimum physician supervision level for each diagnostic X-ray and other diagnostic test service along with the codes and relative values for these services in the PFS Relative Value File, which is posted on the CMS website at
In response to the Request for Information on CMS Flexibilities and Efficiencies (RFI) that was issued in the CY 2018 PFS proposed rule (82 FR 34172 through 34173), many commenters recommended that we revise the physician supervision requirements at § 410.32(b) for diagnostic tests with a focus on those that are typically furnished by a radiologist assistant (RA) under the supervision of a physician. Specifically, the commenters stated that all diagnostic tests, when performed by RAs, can be furnished under direct supervision rather than personal supervision of a physician, and that we should revise the Medicare supervision requirements so that when RAs conduct diagnostic imaging tests that would otherwise require personal supervision, they only need to do so under direct supervision. In addition to increasing efficiency, stakeholders suggested that the current supervision requirements for certain diagnostic imaging services unduly restrict RAs from conducting tests that they are permitted to do under current law in many states.
After consideration of these comments on the RFI, as well as information provided by stakeholders, we proposed to revise our regulations to specify that all diagnostic imaging tests may be furnished under the direct supervision of a physician when performed by an RA in accordance with state law and state scope of practice rules. Stakeholders representing the radiology community have provided us with information showing that the RA designation includes registered radiologist assistants (RRAs) who are certified by The American Registry of Radiologic Technologists, and radiology practitioner assistants (RPAs) who are certified by the Certification Board for Radiology Practitioner Assistants. We proposed to revise our regulation at § 410.32 to add a new paragraph (b)(4) to state that diagnostic tests performed by an RRA or an RPA require only a direct level of physician supervision, when permitted by state law and state scope of practice regulations. We noted that for diagnostic imaging tests requiring a general level of physician supervision, this proposal would not change the level of physician supervision to direct supervision. Otherwise, the diagnostic imaging tests must be performed as specified elsewhere under § 410.32(b). We based this proposal on recommendations from the practitioner community that included specific recommendations on how to implement the change. Representatives of the practitioner community submitted information on the education and clinical experience of RAs, which we took into consideration in determining whether the proposal would pose a significant risk to patient safety, and we determined that it would not. In addition, we considered information provided by stakeholders that indicated that 28 states have statutes or regulations that recognize RAs, and these states have general or direct supervision requirements for RAs.
After consideration of the public comments received, we are finalizing, with refinements for further clarity, our proposed revisions to § 410.32, by adding a new paragraph (b)(4) that states that diagnostic tests that are performed by a registered radiologist assistant (RRA) who is certified and registered by the American Registry of Radiologic Technologists or a radiology practitioner assistant (RPA) who is certified by the Certification Board for Radiology Practitioner Assistants, and that would otherwise require a personal level of supervision as specified in paragraph (3), may be furnished under a direct level of physician supervision to the extent permitted by state law and state scope of practice regulations.
Sections 1833(t)(1)(B)(v) and (t)(21) of the Act require that certain items and services furnished by certain off-campus provider-based departments (PBDs) (collectively referenced here as nonexcepted items and services furnished by nonexcepted off-campus PBDs) shall not be considered covered outpatient department (OPD) services for purposes of payment under the Hospital Outpatient Prospective Payment System (OPPS), and payment for those nonexcepted items and services furnished on or after January 1, 2017 shall be made under the applicable payment system under Medicare Part B if the requirements for such payment are otherwise met. These requirements were enacted in section 603 of the Bipartisan Budget Act of 2015 (Pub. L. 114-74, enacted November 2, 2015).
In the CY 2017 OPPS/Ambulatory Surgical Center (ASC) final rule with comment period (81 FR 79699 through 79719), we established several policies and provisions to define the scope of nonexcepted items and services in nonexcepted off-campus PBDs. We also finalized the PFS as the applicable payment system for most nonexcepted items and services furnished by nonexcepted off-campus PBDs. At the same time, we issued an interim final rule with comment period (81 FR 79720 through 79729) in which we established payment policies under the PFS for nonexcepted items and services furnished on or after January 1, 2017. In the following paragraphs, we summarize the policies that we adopted for CY 2017 and CY 2018. We also summarize proposals for CY 2019, respond to public comments, and finalize payment policies for CY 2019. For issues related to the excepted status of off-campus PBDs or the excepted status of items and services, please see the CY 2019 OPPS/ASC final rule.
In establishing the PFS as the applicable payment system for most nonexcepted items and services in nonexcepted off-campus PBDs under sections 1833(t)(1)(B)(v) and (t)(21) of the Act, we recognized that there was no technological capability, at least in the near term, to allow off-campus PBDs to bill under the PFS for those nonexcepted items and services. Off-campus PBDs bill under the OPPS for their services on an institutional claim,
We implemented requirements under section 1833(t)(1)(B) of the Act for CY 2017 and CY 2018 by applying an overall downward scaling factor, called the PFS Relativity Adjuster to payments for nonexcepted items and services furnished in nonexcepted off-campus PBDs. The PFS Relativity Adjuster generally reflects the average (weighted by claim line volume times rate) of the site-specific rate under the PFS compared to the rate under the OPPS (weighted by claim line volume times rate) for nonexcepted items and services furnished in nonexcepted off-campus PBDs. As we have discussed extensively in prior rulemaking (81 FR 97920 through 97929 and 82 FR 53021), we established a new set of site-specific payment rates under the PFS that reflect the relative resource cost of furnishing the technical component (TC) of services furnished in nonexcepted off-campus PBDs. For the majority of HCPCS codes, these rates are based on either (1) the difference between the PFS nonfacility payment rate and the PFS facility rate, (2) the TC, or (3) in instances where payment would have been made only to the facility or to the physician, the full nonfacility rate. The PFS Relativity Adjuster refers to the percentage of the OPPS payment amount paid under the PFS for a nonexcepted item or service to the nonexcepted off-campus PBD.
To operationalize the PFS Relativity Adjuster as a mechanism to pay for nonexcepted items and services furnished by nonexcepted off-campus PBDs, we adopted the packaging payment rates and multiple procedure payment reduction (MPPR) percentage that applies under the OPPS. We also incorporated the claims processing logic that is used for payments under the OPPS for comprehensive Ambulatory Payment Classifications (C-APCs), conditionally and unconditionally packaged items and services, and major procedures. As we noted in the CY 2017 PFS final rule (82 FR 53024), we believe that this maintains the integrity of the cost-specific relativity of current payments under the OPPS compared with those under the PFS.
In CY 2017, we implemented a PFS Relativity Adjuster of 50 percent of the OPPS rate for nonexcepted items and services furnished in nonexcepted off-campus PBDs. For a detailed explanation of how we developed the PFS Relativity Adjuster of 50 percent for CY 2017, including assumptions and exclusions, we refer readers to the CY 2017 OPPS/ASC interim final rule with comment period (81 FR 79720 through 79729). Beginning for CY 2018, we adopted a PFS Relativity Adjuster of 40 percent of the OPPS rate. For a detailed explanation of how we developed the PFS Relativity Adjuster of 40 percent, we refer readers to the CY 2018 PFS final rule (82 FR 53019 through 53042). A brief overview of the general approach we took for CY 2018 and how it differs from the proposal for CY 2019 appears in this section.
The PFS Relativity Adjuster reflects the overall relativity of the applicable payment rate for nonexcepted items and services furnished in nonexcepted off-campus PBDs under the PFS compared with the rate under the OPPS. To develop the PFS Relativity Adjuster for CY 2017, we did not have all of the claims data needed to identify the mix of items and services that would be billed using the “PN” modifier. Instead, we analyzed hospital outpatient claims data from January 1 through August 25, 2016, that contained the “PO” modifier, which was a new mandatory reporting requirement for CY 2016 for claims that were billed by an off-campus department of a hospital. We limited our analysis to those claims billed on the 13X Type of Bill because those claims were used for Medicare Part B billing under the OPPS. We then identified the 25 most frequently billed major codes that were billed by claim line; that is, items and services that were separately payable or conditionally packaged. Specifically, we restricted our analysis to codes with OPPS status indicators (SI) “J1”, “J2”, “Q1”, “Q2”, “Q3”, “S”, “T”, or “V”. The most frequently billed service with the “PO” modifier in CY 2016 was described by HCPCS code G0463 (Hospital outpatient clinic visit for the assessment and management of a patient), which, in CY 2016, was paid under APC 5012 at a rate of $102.12; the total number of claim lines for this service was approximately 6.7 million as of August 2016. Under the PFS, there are 10 CPT codes describing different levels of office visits for new and established payments. We compared the payment rate under OPPS for HCPCS code G0463 ($102.12) to the average of the difference between the nonfacility and facility rates for CPT code 99213 (Level III office visit for an established patient) and CPT code 99214 (Level IV office visit for an established patient) in CY 2016 and found that the relative payment difference was approximately 22 percent. We did not include HCPCS code G0463 in our calculation of the PFS Relativity Adjuster for CY 2017 because we were concerned that there was no single, directly comparable code under the PFS. As we stated in the CY 2017 PFS final rule (81 FR 79723), we wanted to mitigate the risk of underestimating the overall relativity between the PFS and OPPS rates. From the remaining top 24 most frequently billed codes, we excluded HCPCS code 36591 (Collection of blood specimen from a completely implantable venous access device) because, under PFS policies, the service was only separately payable under the PFS when no other code was on the claim. We also removed HCPCS code G0009 (Administration of Pneumococcal Vaccine) because there was no payment for this code under the PFS. For the remaining top 22 codes furnished with the “PO” modifier in CY 2016, the average (weighted by claim line volume times rate) of the nonfacility payment rate estimate for the PFS compared to the estimate for the OPPS was 45 percent. We indicated that, because of our inability to estimate the effect of the packaging difference between the OPPS and the PFS, we would assume a 5 percentage point adjustment upward from the calculated amount of 45 percent; therefore, we established the PFS Relativity Adjuster of 50 percent for CY 2017.
In establishing the PFS Relativity Adjuster for CY 2018, we still did not have claims data for items and services furnished reported with a “PN” modifier. However, we updated the list of the 25 most frequently billed HCPCS codes using an entire year (CY 2016) of claims data for services submitted with a “PO” modifier and we updated the corresponding utilization weights for the codes used in the analysis. The order and composition of the top 25 separately payable HCPCS codes, based on the full year of claims from CY 2016
In prior rulemaking, we stated our expectation that our general approach of adjusting OPPS payments using a single scaling factor, the PFS Relativity Adjuster, would continue to be an appropriate payment mechanism to implement provisions of section 603 of the Bipartisan Budget Act of 2015, and would remain in place until we are able to establish code-specific reductions that represent the TC of services furnished under the PFS or until we are able to implement system changes needed to enable nonexcepted off-campus PBDs to bill for nonexcepted items and services under the PFS directly (82 FR 53029). As we continue to explore alternative options related to requirements under section 1833(t)(21)(C) of the Act, we believed that this overall approach is still appropriate, and we are finalizing our proposal to continue to allow nonexcepted off-campus PBDs to bill for nonexcepted items and services on an institutional claim using a “PN” modifier until we identify a workable alternative mechanism to improve payment accuracy.
We made several adjustments to our methodology for calculating the PFS Relativity Adjuster for CY 2019. Most importantly, we had access to a full year of claims data from CY 2017 for services submitted with the “PN” modifier. Incorporating these data allows us to improve the accuracy of the PFS Relativity Adjuster by accounting for the specific mix of nonexcepted items and services furnished in nonexcepted off-campus PBDs. In analyzing the CY 2017 claims data, we identified just under 2,000 unique OPPS HCPCS/OPPS status indicator (SI) code pairs reported in CY 2017 with status indicators “J1”, “J2”, “Q1”, “Q2”, “Q3”, “S”, “T”, or “V”. The data reinforce our previous observation that the single most frequently reported service furnished in nonexcepted off-campus PBDs is HCPCS code G0463. Approximately half of all claim lines for separately payable or conditionally packaged services furnished by nonexcepted off-campus PBDs included HCPCS code G0463 in CY 2017, representing over 30 percent of total Medicare payments for separately payable or conditionally packaged services. The top 30 HCPCS/SI code combinations accounted for over 80 percent of all claim lines and approximately 70 percent of Medicare payments for services that are separately billable or conditionally packaged. In contrast with prior analyses, we also looked at claims units, which reflect HCPCS/SI code combinations that are billed more than once on a claim line. Certain HCPCS codes are much more frequently billed in multiple units than others. The largest differences between the number of claim lines and the number of claims units are for injections and immunizations, which are not typically separately payable or conditionally packaged under the OPPS. For instance, HCPCS code Q9967 (Low osmolar contrast material, 300-399 mg/ml iodine concentration, per ml) was reported in 12,268 claim lines, but 1,168,393 times (claims units) in the aggregate. HCPCS code Q9967 has an OPPS status indicator of “N”, meaning that there is no separate payment under OPPS (items and services are packaged into APC rates). To calculate the PFS Relativity Adjuster using the full range of claims data submitted with a “PN” modifier in CY 2017, we first established site-specific rates under the PFS that reflect the TC of items and services furnished by nonexcepted off-campus PBDs in CY 2017. These HCPCS-level rates reflect our best current estimate of the amount that would have been paid for the service in the office setting under the PFS for practice expenses (PEs) not associated with the professional component (PC) of the service. As discussed in prior rulemaking (81 FR 79720 through 79729), we believe the most appropriate code-level comparison would reflect the TC of each HCPCS code under the PFS. However, we do not currently calculate a separate TC rate for all HCPCS codes under the PFS—only for those for which the PC and TC of the service are distinct and can be separately billed by two different practitioners or other suppliers under the PFS. For most of the remainder of services that do not have a separately payable TC under the PFS, we estimated the site-specific rate as (1) the difference between the PFS nonfacility rate and the PFS facility rate, or (2) in instances where payment would have been made only to the facility or only to the physician, the full nonfacility rate. As with the PFS rates that we developed when calculating the PFS Relativity Adjuster for CY 2017 and CY 2018, there were large code-level differences between the applicable PFS rate and the OPPS rate.
In calculating the proposed PFS Relativity Adjuster for CY 2019, we employed the same fundamental methodology that we used to calculate the PFS Relativity Adjuster for CY 2017 and CY 2018. We began by limiting our analysis to the items and services billed in CY 2017 with a “PN” modifier that are separately payable or conditionally packaged under the OPPS (status indicator = “J1”, “J2”, “Q1”, “Q2”, “Q3”, “S”, “T”, or “V”) and compared the rates for these codes under the OPPS with the site-specific rates under the PFS. Next, we imputed PFS rates for a limited number of items and services that are separately payable or conditionally packaged under the OPPS but are contractor priced under the PFS. We also imputed PFS rates for some HCPCS codes that are not separately payable under the OPPS (SI = “N”), but are separately payable under the PFS. This includes items and services with an indicator status of “X” under the PFS, which are statutorily excluded from payment under the PFS, but may be paid under a different fee schedule, such as the Clinical Lab Fee Schedule (CLFS). We summed the HCPCS-level
For CY 2019, our proposed PFS Relativity Adjuster was based on all HCPCS codes that were submitted on an institutional claim form in CY 2017, appended with the “PN” modifier in order to improve the accuracy of the overall payment comparison using the best data available regarding the actual mix of services furnished in nonexcepted off-campus PBDs. In contrast, for CYs 2017 and 2018, we used only a subset of claims from CY 2016 because of known limitations regarding the data available at the time. In particular, the data from CY 2016 were based on claims that were appended with the “PO” modifier, which was a new reporting requirement for CY 2016. Although the “PO” modifier allowed us to distinguish items and services furnished in off-campus PBDs in CY 2016, it did not allow us to distinguish between excepted and nonexcepted off-campus PBDs. The “PN” modifier, which was a new reporting requirement for CY 2017, allows us to make the distinction between excepted and nonexcepted off-campus PBDs.
In updating our analysis for calculating the proposed PFS Relativity Adjuster for CY 2019 to include all HCPCS codes that were reported on an institutional claim with the “PN” modifier, we also extended to all HCPCS
To continue with our analysis, we combined the CY 2017 OPPS rates at the HCPCS code level with the CY 2017 claims data representing nonexcepted items and services furnished in nonexcepted off-campus PBDs. Next, we added the technical-equivalent PFS rates for each HCPCS code, calculated using the approach described above. For both the OPPS and the PFS portions of the PFS Relativity Adjuster calculations, we weighted our analysis of HCPCS/SI code combinations by the number of claims units. For the OPPS component of the calculation, we restricted our analysis to HCPCS/SI code combinations that had OPPS SI indicators “J1”, “J2”, “Q1”, “Q2”, “Q3”, “S”, “T”, or “V”, which are separately payable or conditionally packaged codes under the OPPS. We multiplied the number of claims units for each HCPCS/SI code combination by the OPPS rate for each HCPCS/SI code combination and summed across the weighted rates. To calculate the PFS component of the PFS Relativity Adjuster, we used the same OPPS/SI code combinations, but we also included claims for HCPCS codes with OPPS SI “N”, which indicates that, under the OPPS, payment for these services is packaged into payment for other services. We multiplied the number of claims units for each HCPCS/SI code combination by the technical-equivalent PFS rate for each HCPCS code and summed across the HCPCS/SI code combinations. We believe that adding weighted rates for HCPCS codes with OPPS SI “N” to the PFS allows us to better adjust, although imprecisely, for the packaging under the OPPS of nonexcepted items and services for which separate payment would typically be made under the PFS in the office setting. Although we did not conduct code-level analysis to estimate packaging under the OPPS, we believe that the combination of using the full range of claims data for nonexcepted items and services furnished in nonexcepted off-campus PBDs, using claim units rather than claim lines to weight rates on both the OPPS and PFS, and adding PFS rates for HCPCS codes with OPPS status indicator “N” is an improved approach to the PFS Relativity Adjuster that better accounts for OPPS packaging policies.
To increase the precision of our analysis, we imputed payment rates under the PFS for certain HCPCS codes for which payment is based on rates other than national PFS pricing. For services that are contractor-priced under the PFS, as indicated by a PFS status indicator of “C”, we applied the national median allowed charge for these services in CY 2017. For a limited number of other services, where appropriate, we incorporated rates from the applicable fee schedule under which the service may have been paid if furnished in a freestanding office. For instance, HCPCS codes with a PFS status indicator of either “X” (service is statutorily excluded for payment under PFS) or “E” (service is excluded from payment under PFS by regulation), may be paid under the CLFS or the National Limitation Amount (NLA). The imputed values that we used, both from contractor priced codes and other fee schedules, are included in the data file that will be posted with this final rule, available at
Although there remains a certain level of imprecision inherent in our analysis, we believe the margin of error is relatively small and would likely affect the PFS and OPPS amounts similarly. For instance, we did not take into account the several MPPRs that would reduce payment on the PFS side when multiple codes are billed together. In many cases, these codes are packaged under the OPPS, so not including the PFS MPPRs in our analysis has the effect of increasing the PFS component of the calculation by a marginal amount. Likewise, we recognize that because of existing packaging rules under the OPPS, there is likely to be underreporting of codes on institutional claims for which the hospital does not receive separate payment, but for which the practitioner might receive separate payment if furnished in a freestanding office and reported on a professional claim form. This would effectively reduce the PFS Relativity Adjuster, but only to the extent hospitals are not appropriately reporting furnished items and services.
We recognize that the process of allocating indirect costs under the PFS is built on assumptions about
Despite concerns about the appropriateness of the PFS Relativity Adjuster for implementing requirements under section 603 of the Bipartisan Budget Act of 2015, several of the same commenters pointed out that there are significant advantages of continuing to allow hospitals to bill for items and services furnished in nonexcepted PBDs using the institutional claim form. In particular, they stated, this allows PBDs to properly use cost reporting procedures and to accurately reconcile the cost report to hospital ledgers for all services and departments and to correctly allow revenue for nonexcepted PBDs to flow through the Provider Statistical and Reimbursement (PS&R) report.
We continue to explore options that would allow hospitals to report nonexcepted items and services on an institutional claim form but receive payments that more directly reflect the technical aspect of services under the PFS. In general, we believe there may be additional utility, especially in the context of improving price transparency for Medicare beneficiaries, in establishing and displaying a set of payment rates, recalculated annually as part of the annual PFS rulemaking cycle, that reflect the relative resource costs of the technical aspects of furnishing PFS services.
Along with this final rule, we are including the technical-equivalent rates that we developed specifically for calculating the PFS Relativity Adjuster for CY 2019, which is the current mechanism for implementing the PFS as the applicable payment system for nonexcepted items and services furnished in nonexcepted off-campus PBDs. This information is being made available under the downloads section for this final rule on the CMS website at
We believe that our proposal to maintain the PFS Relativity Adjuster at 40 percent for CY 2019 and for future years reflects an analysis that accounts for many of the concerns expressed by commenters regarding the PFS Relativity Adjuster in prior rules. Therefore, we are finalizing the proposal to maintain the PFS Relativity Adjuster at 40 percent for CY 2019 and beyond until there is an appropriate reason and process for implementing an alternative to our current policy, at which time we will make a proposal through notice and comment rulemaking.
In the CY 2018 PFS final rule (81FR 53019 through 53031), we finalized policies related to supervision rules, beneficiary cost sharing, and geographic adjustments. We finalized that supervision rules in nonexcepted off-campus PBDs that furnish nonexcepted items and services are the same as those that apply for hospitals, in general. We also finalized that all beneficiary cost sharing rules that apply under the PFS in accordance with sections 1848(g) and 1866(a)(2)(A) of the Act continue to apply when payment is made under the PFS for nonexcepted items and services furnished by nonexcepted off-campus PBDs, regardless of cost sharing obligations under the OPPS. Lastly, we finalized the policy to apply the same geographic adjustments used under the OPPS to nonexcepted items and services furnished in nonexcepted off-campus PBDs. We are maintaining these policies for CY 2019, as finalized in the CY 2018 PFS final rule.
Partial hospitalization programs (PHPs) are intensive outpatient psychiatric day treatment programs furnished to patients as an alternative to inpatient psychiatric hospitalization, or as a stepdown to shorten an inpatient stay and transition a patient to a less intensive level of care. Section
In response to that rule, commenters expressed concern that without a clear payment mechanism for PHP services furnished by nonexcepted off-campus PBDs, access to partial hospitalization services would be limited, and pointed out the critical role PHPs play in the continuum of mental health care. Many commenters noted that the Congress did not intend for partial hospitalization services to no longer be paid for by Medicare when such services are furnished by nonexcepted off-campus PBDs. Several commenters disagreed with the notion of enrolling as a CMHC in order to receive payment for PHP services. The commenters stated that hospital-based PHPs and CMHCs are inherently different in structure, operation, and payment, and noted that the conditions of participation for hospital departments and CMHCs are different. Several commenters requested that CMS find a mechanism to pay hospital-based PHPs in nonexcepted off-campus PBDs.
We agreed with the commenters' concerns and adopted payment for partial hospitalization items and services furnished by nonexcepted off-campus PBDs under the PFS in the CY 2017 OPPS/ASC final rule with comment period and interim final rule with comment period (81 FR 79715, 79717, and 79727). When billed in accordance with the CY 2017 PFS final rule, these partial hospitalization services are paid at the CMHC per diem rate for APC 5853, for providing three or more partial hospitalization services per day (81 FR 79727).
In the CY 2017 OPPS/ASC proposed rule (81 FR 45681), and the CY 2017 OPPS/ASC final rule with comment period/interim final rule with comment period (81 FR 79717 and 79727), we noted that when a beneficiary receives outpatient services in an off-campus department of a hospital, the total Medicare payment for those services is generally higher than when those same services are provided in a physician's office. Similarly, when partial hospitalization services are provided in a hospital-based PHP, Medicare pays more than when those same services are provided by a CMHC. Our rationale for adopting the CMHC per diem rate for APC 5853 as the PFS payment amount for nonexcepted off-campus PBDs providing PHP services is because CMHCs are freestanding entities that are not part of a hospital, but they provide the same PHP services as hospital-based PHPs (81 FR 79727). This is similar to the differences between freestanding entities paid under the PFS that furnish other services also provided by hospital-based entities. Similar to other entities currently paid for their TC services under the PFS, we believe CMHCs would typically have lower cost structures than hospital-based PHPs, largely due to lower overhead costs and other indirect costs such as administration, personnel, and security. We believe that paying for nonexcepted hospital-based partial hospitalization services at the lower CMHC per diem rate aligns with section 603 of Bipartisan Budget Act of 2015, while also preserving access to PHP services. In addition, nonexcepted off-campus PBDs will not be required to enroll as CMHCs in order to bill and be paid for providing partial hospitalization services. However, a nonexcepted off-campus PBD that wishes to provide PHP services may still enroll as a CMHC if it chooses to do so and meets the relevant requirements. Finally, we recognize that because hospital-based PHPs are providing partial hospitalization services in the hospital outpatient setting, they can offer benefits that CMHCs do not have, such as an easier patient transition to and from inpatient care, and easier sharing of health information between the PHP and the inpatient staff.
In the CY 2018 PFS final rule, we did not require these PHPs to enroll as CMHCs but instead we continued to pay nonexcepted off-campus PBDs providing PHP items and services under the PFS. Further, in that CY 2018 PFS final rule (82 FR 53025 to 53026), we continued to adopt the CMHC per diem rate for APC 5853 as the PFS payment amount for nonexcepted off-campus PBDs providing three or more PHP services per day in CY 2018.
For CY 2019, we proposed to continue to identify the PFS as the applicable payment system for PHP services furnished by nonexcepted off-campus PBDs, and proposed to continue to set the PFS payment rate for these PHP services as the per diem rate that will be paid to a CMHC in CY 2019. We further proposed to maintain these policies for future years until updated data or other considerations indicate that a change to our approach is warranted, which we will then propose through notice and comment rulemaking.
We received no comments on our PHP proposals for CY 2019 and future years, and are finalizing our policies as proposed.
We continue to believe the amendments made by section 603 of the Bipartisan Budget Act of 2015 were intended to reduce the Medicare payment incentive for hospitals to purchase physician offices, convert them to off-campus PBDs, and bill under the OPPS for items and services they furnish there. Therefore, we continue to believe the payment policy under this provision should ultimately equalize payment rates between nonexcepted off-campus PBDs and physician offices to the greatest extent possible, while allowing nonexcepted off-campus PBDs to bill in a straight-forward way for services they furnish.
In developing our proposal for CY 2019 as described previously, we incorporated all HCPCS codes that appeared in CY 2017 claims data from nonexcepted off-campus PBDs. We also expanded the number of site specific, technical-equivalent rates for nonexcepted items and services furnished in nonexcepted off-campus PBDs, in order to ensure that Medicare payment to hospitals billing for nonexcepted items and services furnished by nonexcepted off-campus PBDs reflects the relative resources involved in furnishing the items and services. We recognize that for certain specialties, service lines, and nonexcepted off-campus PBDs, total Medicare payments for the same services might be either higher or lower when furnished by a nonexcepted off-campus PBD rather than in a physician office.
We intend to continue to examine the claims data in order to assess whether a different PFS Relativity Adjuster is warranted and also to consider whether additional adjustments to the methodology are appropriate. In particular, we are monitoring claims for shifts in the mix of services furnished in nonexcepted off-campus PBDs that may affect the relativity between the PFS and OPPS. An increase over time in the share of nonexcepted items and services with lower technical-equivalent rates under the PFS compared with APC rates
Another dimension of our ongoing efforts to improve implementation of section 603 of the Bipartisan Budget Act of 2015 is the development and refinement of a new set of payment rates under the PFS that reflect the relative resource costs of furnishing the TC of items and services furnished in nonexcepted off-campus PBDs. Although we believe that our site-specific HCPCS code-level rates reflect the best available estimate of the amount that would have been paid for the service in the office setting under the PFS for practice expenses not associated with the PC of the service, for the majority of HCPCS codes there is no established methodology for separately valuing the resource costs incurred by a provider while furnishing a service from those incurred exclusively by the facility in which the service is furnished. We continue to explore alternatives to our current estimates that would better reflect the TC of services furnished in nonexcepted off-campus PBDs. We are broadly interested in stakeholder feedback and recommendations for ways in which CMS can improve pricing and transparency with regard to the differences in the payment rates across sites of service.
We expect that our continued analyses of claims data and our ongoing exploration of systems changes that are needed to allow nonexcepted off-campus PBDs to bill directly for the TC portion of nonexcepted items and services may lead us to consider a different approach for implementing section 603 of the Bipartisan Budget Act of 2015. On the whole, however, we believe that a PFS Relativity Adjuster for CY 2019 of 40 percent advances efforts to equalize payment rates in the aggregate between physician offices and nonexcepted off-campus PBDs. Maintaining our policy of applying an overall scaling factor to OPPS payments allows hospitals to continue billing through a facility claim form and permits continued use of the packaging rules and cost report-based relative payment rate determinations for nonexcepted services.
Establishing valuations for newly created and revised CPT codes is a routine part of maintaining the PFS. Since the inception of the PFS, it has also been a priority to revalue services regularly to make sure that the payment rates reflect the changing trends in the practice of medicine and current prices for inputs used in the PE calculations. Initially, this was accomplished primarily through the 5-year review process, which resulted in revised work RVUs for CY 1997, CY 2002, CY 2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY 2011, and revised MP RVUs in CY 2010 and CY 2015. Under the 5-year review process, revisions in RVUs were proposed and finalized via rulemaking. In addition to the 5-year reviews, beginning with CY 2009, CMS and the RUC identified a number of potentially misvalued codes each year using various identification screens, as discussed in section II.E. of this final rule, Potentially Misvalued Services under the PFS. Historically, when we received RUC recommendations, our process had been to establish interim final RVUs for the potentially misvalued codes, new codes, and any other codes for which there were coding changes in the final rule with comment period for a year. Then, during the 60-day period following the publication of the final rule with comment period, we accepted public comment about those valuations. For services furnished during the calendar year following the publication of interim final rates, we paid for services based upon the interim final values established in the final rule. In the final rule with comment period for the subsequent year, we considered and responded to public comments received on the interim final values, and typically made any appropriate adjustments and finalized those values.
In the CY 2015 PFS final rule with comment period, we finalized a new process for establishing values for new, revised and potentially misvalued codes. Under the new process, we include proposed values for these services in the proposed rule, rather than establishing them as interim final in the final rule with comment period. Beginning with the CY 2017 PFS proposed rule, the new process was applicable to all codes, except for new codes that describe truly new services. For CY 2017, we proposed new values in the CY 2017 PFS proposed rule for the vast majority of new, revised, and potentially misvalued codes for which we received complete RUC recommendations by February 10, 2016. To complete the transition to this new process, for codes for which we established interim final values in the CY 2016 PFS final rule with comment period, we reviewed the comments received during the 60-day public comment period following release of the CY 2016 PFS final rule with comment period, and re-proposed values for those codes in the CY 2017 PFS proposed rule.
We considered public comments received during the 60-day public comment period for the proposed rule before establishing final values in the CY 2017 PFS final rule. As part of our established process, we will adopt interim final values only in the case of wholly new services for which there are no predecessor codes or values and for which we do not receive recommendations in time to propose values. For CY 2017, we did not identify any new codes that described such wholly new services. Therefore, we did not establish any code values on an interim final basis.
For CY 2018, we generally proposed the RUC-recommended work RVUs for new, revised, and potentially misvalued codes. We proposed these values based on our understanding that the RUC generally considers the kinds of concerns we historically raised regarding appropriate valuation of work RVUs. However, during our review of these recommended values, we identified some concerns similar to those we recognized in prior years. Given the relative nature of the PFS and our obligation to ensure that the RVUs reflect relative resource use, we included descriptions of potential alternative approaches we might have taken in developing work RVUs that differed from the RUC-recommended values. We sought comment on both the RUC-recommended values, as well as the alternatives considered. Several commenters generally supported the proposed use of the RUC-recommended work RVUs, without refinement. Other commenters expressed concern about the effect of the misvalued code reviews on particular specialties and settings and disappointment with our proposed
We clarified in response to commenters that we are not relinquishing our obligation to independently establish appropriate RVUs for services paid under the PFS. We will continue to thoroughly review and consider information we receive from the RUC, the Health Care Professionals Advisory Committee (HCPAC), public commenters, medical literature, Medicare claims data, comparative databases, comparison with other codes within the PFS, as well as consultation with other physicians and healthcare professionals within CMS and the federal government as part of our process for establishing valuations. Although generally proposing the RUC-recommended work RVUs for new, revised, and potentially misvalued codes was our approach for CY 2018, we note that we also included alternative values where we believed there was a possible opportunity for increased precision. We also clarified that as part of our obligation to establish RVUs for the PFS, we annually make an independent assessment of the available recommendations, supporting documentation, and other available information from the RUC and other commenters to determine the appropriate valuations. Where we concur that the RUC's recommendations, or recommendations from other commenters, are reasonable and appropriate and are consistent with the time and intensity paradigm of physician work, we propose those values as recommended. Additionally, we will continue to engage with stakeholders, including the RUC, with regard to our approach for accurately valuing codes, and as we prioritize our obligation to value new, revised, and potentially misvalued codes. We continue to welcome feedback from all interested parties regarding valuation of services for consideration through our rulemaking process.
For each code identified in this section, we conducted a review that included the current work RVU (if any), RUC-recommended work RVU, intensity, time to furnish the preservice, intraservice, and postservice activities, as well as other components of the service that contribute to the value. Our reviews of recommended work RVUs and time inputs generally included, but had not been limited to, a review of information provided by the RUC, the HCPAC, and other public commenters, medical literature, and comparative databases, as well as a comparison with other codes within the PFS, consultation with other physicians and health care professionals within CMS and the federal government, as well as Medicare claims data. We also assessed the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters and the rationale for the recommendations. In the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329), we discussed a variety of methodologies and approaches used to develop work RVUs, including survey data, building blocks, crosswalks to key reference or similar codes, and magnitude estimation (see the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329) for more information). When referring to a survey, unless otherwise noted, we mean the surveys conducted by specialty societies as part of the formal RUC process.
Components that we used in the building block approach may have included preservice, intraservice, or postservice time and post-procedure visits. When referring to a bundled CPT code, the building block components could include the CPT codes that make up the bundled code and the inputs associated with those codes. We used the building block methodology to construct, or deconstruct, the work RVU for a CPT code based on component pieces of the code. Magnitude estimation refers to a methodology for valuing work that determines the appropriate work RVU for a service by gauging the total amount of work for that service relative to the work for a similar service across the PFS without explicitly valuing the components of that work. In addition to these methodologies, we frequently utilized an incremental methodology in which we value a code based upon its incremental difference between another code and another family of codes. The statute specifically defines the work component as the resources in time and intensity required in furnishing the service. Also, the published literature on valuing work has recognized the key role of time in overall work. For particular codes, we refined the work RVUs in direct proportion to the changes in the best information regarding the time resources involved in furnishing particular services, either considering the total time or the intraservice time.
Several years ago, to aid in the development of preservice time recommendations for new and revised CPT codes, the RUC created standardized preservice time packages. The packages include preservice evaluation time, preservice positioning time, and preservice scrub, dress and wait time. Currently, there are preservice time packages for services typically furnished in the facility setting (for example, preservice time packages reflecting the different combinations of straightforward or difficult procedure, and straightforward or difficult patient). Currently, there are three preservice time packages for services typically furnished in the nonfacility setting.
We developed several standard building block methodologies to value services appropriately when they have common billing patterns. In cases where a service is typically furnished to a beneficiary on the same day as an evaluation and management (E/M) service, we believe that there is overlap between the two services in some of the activities furnished during the preservice evaluation and postservice time. Our longstanding adjustments have reflected a broad assumption that at least one-third of the work time in both the preservice evaluation and postservice period is duplicative of work furnished during the E/M visit.
Accordingly, in cases where we believe that the RUC has not adequately accounted for the overlapping activities in the recommended work RVU and/or times, we adjusted the work RVU and/or times to account for the overlap. The work RVU for a service is the product of the time involved in furnishing the service multiplied by the intensity of the work. Preservice evaluation time and postservice time both have a long-established intensity of work per unit of time (IWPUT) of 0.0224, which means that 1 minute of preservice evaluation or postservice time equates to 0.0224 of a work RVU.
Therefore, in many cases when we removed 2 minutes of preservice time and 2 minutes of postservice time from a procedure to account for the overlap with the same day E/M service, we also removed a work RVU of 0.09 (4 minutes × 0.0224 IWPUT) if we did not believe the overlap in time had already been accounted for in the work RVU. The RUC has recognized this valuation policy and, in many cases, now addresses the overlap in time and work when a service is typically furnished on the same day as an E/M service.
The following paragraphs contain a general discussion of our approach to reviewing RUC recommendations and developing proposed values for specific codes. When they exist we also include a summary of stakeholder reactions to
We have observed that for many codes reviewed by the RUC, recommended work RVUs have appeared to be incongruous with recommended assumptions regarding the resource costs in time. This has been the case for a significant portion of codes for which we recently established or proposed work RVUs that are based on refinements to the RUC-recommended values. When we have adjusted work RVUs to account for significant changes in time, we have started by looking at the change in the time in the context of the RUC-recommended work RVU. When the recommended work RVUs do not appear to account for significant changes in time, we have employed the different approaches to identify potential values that reconcile the recommended work RVUs with the recommended time values. Many of these methodologies, such as survey data, building block, crosswalks to key reference or similar codes, and magnitude estimation have long been used in developing work RVUs under the PFS. In addition to these, we sometimes used the relationship between the old time values and the new time values for particular services to identify alternative work RVUs based on changes in time components.
In so doing, rather than ignoring the RUC-recommended value, we have used the recommended values as a starting reference and then applied one of these several methodologies to account for the reductions in time that we believe were not otherwise reflected in the RUC-recommended value. If we believed that such changes in time were already accounted for in the RUC's recommendation, then we did not make such adjustments. Likewise, we did not arbitrarily apply time ratios to current work RVUs to calculate proposed work RVUs. We used the ratios to identify potential work RVUs and considered these work RVUs as potential options relative to the values developed through other options.
We do not imply that the decrease in time as reflected in survey values should always equate to a one-to-one or linear decrease in newly valued work RVUs. Instead, we have believed that, since the two components of work are time and intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs. If the RUC's recommendation has appeared to disregard or dismiss the changes in time, without a persuasive explanation of why such a change should not be accounted for in the overall work of the service, then we have generally used one of the aforementioned methodologies to identify potential work RVUs, including the methodologies intended to account for the changes in the resources involved in furnishing the procedure.
Several stakeholders, including the RUC, have expressed general objections to our use of these methodologies and deemed our actions in adjusting the recommended work RVUs as inappropriate; other stakeholders have also expressed general concerns with CMS refinements to RUC recommended values in general. In the CY 2017 PFS final rule (81 FR 80272 through 80277) we responded in detail to several comments that we received regarding this issue. In the CY 2017 PFS proposed rule, we requested comments regarding potential alternatives to making adjustments that would recognize overall estimates of work in the context of changes in the resource of time for particular services; however, we did not receive any specific potential alternatives. As described earlier in this section, crosswalks to key reference or similar codes is one of the many methodological approaches we have employed to identify potential values that reconcile the RUC-recommend work RVUs with the recommended time values when the RUC-recommended work RVUs did not appear to account for significant changes in time.
Following the publication of the CY 2019 PFS proposed rule, we received several comments noting that there was some confusion in the terminology between “reference services” and “crosswalks.” Commenters stated that “reference services” are services indicated by the specialty society or the RUC as a good comparator that demonstrates relativity using magnitude estimation as requiring similar physician work, time, intensity and complexity. “Key reference services” are the top two services selected by the survey respondents as most similar to the code being surveyed. By contrast, “crosswalks” are services that have similar or exact intraservice time and require the same physician work (that is, have the same work RVU), and the term “crosswalk” should only be used when making a comparison to a CPT code with the identical work RVU. The commenters noted that these terms were used interchangeably in the proposed rule when they have distinct and separate meanings.
In response to the commenters, we would like to clarify that the terms “reference services”, “key reference services”, and “crosswalks” as described by the commenters are part of the RUC's process for code valuation. These are not terms that we created, and we do not agree that we necessarily must employ them in the identical fashion for the purposes of discussing our valuation of individual services that come up for review. However, in the interest of minimizing confusion and providing clear language to facilitate stakeholder feedback, we will seek to limit the use of the term, “crosswalk,” to those cases where we are making a comparison to a CPT code with the identical work RVU.
We look forward to continuing to engage with stakeholders and commenters, including the RUC, as we prioritize our obligation to value new, revised, and potentially misvalued codes; and will continue to welcome feedback from all interested parties regarding valuation of services for consideration through our rulemaking process. We refer readers to the detailed discussion in this section of the final valuation considered for specific codes. Table 13 contains a list of codes for which we are finalizing work RVUs; this includes all codes for which we received RUC recommendations by February 10, 2018. The finalized work RVUs, work time and other payment information for all CY 2019 payable codes are available on the CMS website under downloads for the CY 2019 PFS final rule at
On an annual basis, the RUC provides us with recommendations regarding PE inputs for new, revised, and potentially misvalued codes. We review the RUC-recommended direct PE inputs on a code by code basis. Like our review of recommended work RVUs, our review of recommended direct PE inputs generally includes, but is not limited to, a review of information provided by the RUC, HCPAC, and other public commenters, medical literature, and comparative databases, as well as a comparison with other codes within the PFS, and consultation with physicians and health care professionals within CMS and the federal government, as well as Medicare claims data. We also assess the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters and the rationale for the recommendations. When we determine that the RUC's recommendations appropriately estimate the direct PE inputs (clinical labor, disposable supplies, and medical equipment) required for the typical service, are consistent with the principles of relativity, and reflect our payment policies, we use those direct PE inputs to value a service. If not, we refine the recommended PE inputs to better reflect our estimate of the PE resources required for the service. We also confirm whether CPT codes should have facility and/or nonfacility direct PE inputs and refine the inputs accordingly.
Our review and refinement of RUC-recommended direct PE inputs includes many refinements that are common across codes, as well as refinements that are specific to particular services. Table 14 details our refinements of the RUC's direct PE recommendations at the code-specific level. In this final rule, we address several refinements that are common across codes, and refinements to particular codes are addressed in the portions of this section that are dedicated to particular codes. We note that for each refinement, we indicate the impact on direct costs for that service. We note that, on average, in any case where the impact on the direct cost for a particular refinement is $0.30 or less, the refinement has no impact on the PE RVUs. This calculation considers both the impact on the direct portion of the PE RVU, as well as the impact on the indirect allocator for the average service. We also note that nearly half of the refinements listed in Table 14 result in changes under the $0.30 threshold and are unlikely to result in a change to the RVUs.
We also note that the finalized direct PE inputs for CY 2019 are displayed in the CY 2019 direct PE input database, available on the CMS website under the downloads for the CY 2019 PFS final rule at
Some direct PE inputs are directly affected by revisions in work time. Specifically, changes in the intraservice portions of the work time and changes in the number or level of postoperative visits associated with the global periods result in corresponding changes to direct PE inputs. The direct PE input recommendations generally correspond to the work time values associated with services. We believe that inadvertent discrepancies between work time values and direct PE inputs should be refined or adjusted in the establishment of proposed direct PE inputs to resolve the discrepancies.
Prior to CY 2010, the RUC did not generally provide CMS with recommendations regarding equipment time inputs. In CY 2010, in the interest of ensuring the greatest possible degree of accuracy in allocating equipment minutes, we requested that the RUC provide equipment times along with the other direct PE recommendations, and we provided the RUC with general guidelines regarding appropriate equipment time inputs. We appreciate the RUC's willingness to provide us with these additional inputs as part of its PE recommendations.
In general, the equipment time inputs correspond to the service period portion of the clinical labor times. We clarified this principle over several years of rulemaking, indicating that we consider equipment time as the time within the intraservice period when a clinician is using the piece of equipment plus any additional time that the piece of equipment is not available for use for another patient due to its use during the designated procedure. For those services for which we allocate cleaning time to portable equipment items, because the portable equipment does not need to be cleaned in the room where the service is furnished, we do not include that cleaning time for the remaining equipment items, as those items and the room are both available for use for other patients during that time. In addition, when a piece of equipment is typically used during follow-up postoperative visits included in the global period for a service, the equipment time would also reflect that use.
We believe that certain highly technical pieces of equipment and equipment rooms are less likely to be used during all of the preservice or postservice tasks performed by clinical labor staff on the day of the procedure (the clinical labor service period) and are typically available for other patients even when one member of the clinical staff may be occupied with a preservice or postservice task related to the procedure. We also note that we believe these same assumptions would apply to inexpensive equipment items that are used in conjunction with and located in a room with non-portable highly technical equipment items since any items in the room in question would be available if the room is not being occupied by a particular patient. For additional information, we refer readers to our discussion of these issues in the CY 2012 PFS final rule with comment period (76 FR 73182) and the CY 2015 PFS final rule with comment period (79 FR 67639).
In general, the preservice, intraservice, and postservice clinical labor minutes associated with clinical labor inputs in the direct PE input database reflect the sum of particular tasks described in the information that accompanies the RUC-recommended direct PE inputs, commonly called the “PE worksheets.” For most of these described tasks, there is a standardized number of minutes, depending on the type of procedure, its typical setting, its global period, and the other procedures with which it is typically reported. The RUC sometimes recommends a number of minutes either greater than or less than the time typically allotted for certain tasks. In those cases, we review the deviations from the standards and any rationale provided for the deviations. When we do not accept the RUC-recommended exceptions, we refine the proposed direct PE inputs to conform to the standard times for those tasks. In addition, in cases when a service is typically billed with an E/M service, we remove the preservice clinical labor tasks to avoid duplicative inputs and to reflect the resource costs of furnishing the typical service.
We refer readers to section II.B. of this final rule, Determination of Practice
In some cases, the PE worksheets included with the RUC's recommendations include items that are not clinical labor, disposable supplies, or medical equipment or that cannot be allocated to individual services or patients. We addressed these kinds of recommendations in previous rulemaking (78 FR 74242), and we do not use items included in these recommendations as direct PE inputs in the calculation of PE RVUs.
The RUC generally recommends the use of supply and equipment items that already exist in the direct PE input database for new, revised, and potentially misvalued codes. Some recommendations, however, include supply or equipment items that are not currently in the direct PE input database. In these cases, the RUC has historically recommended that a new item be created and has facilitated our pricing of that item by working with the specialty societies to provide us copies of sales invoices. For CY 2019, we received invoices for several new supply and equipment items. Tables 14 and 15 detail the invoices received for new and existing items in the direct PE database. As discussed in section II.B. of this final rule, we encouraged stakeholders to review the prices associated with these new and existing items to determine whether these prices appear to be accurate. Where prices appear inaccurate, we encouraged stakeholders to submit invoices or other information to improve the accuracy of pricing for these items in the direct PE database by February 10th of the following year for consideration in future rulemaking, similar to our process for consideration of RUC recommendations.
We remind stakeholders that due to the relativity inherent in the development of RVUs, reductions in existing prices for any items in the direct PE database increase the pool of direct PE RVUs available to all other PFS services. Tables 14 and 15 also include the number of invoices received and the number of nonfacility allowed services for procedures that use these equipment items. We provide the nonfacility allowed services so that stakeholders will note the impact the particular price might have on PE relativity, as well as to identify items that are used frequently, since we believe that stakeholders are more likely to have better pricing information for items used more frequently. A single invoice may not be reflective of typical costs and we encourage stakeholders to provide additional invoices so that we might identify and use accurate prices in the development of PE RVUs.
In some cases, we do not use the price listed on the invoice that accompanies the recommendation because we identify publicly available alternative prices or information that suggests a different price is more accurate. In these cases, we include this in the discussion of these codes. In other cases, we cannot adequately price a newly recommended item due to inadequate information. Sometimes, no supporting information regarding the price of the item has been included in the recommendation. In other cases, the supporting information does not demonstrate that the item has been purchased at the listed price (for example, vendor price quotes instead of paid invoices). In cases where the information provided on the item allows us to identify clinically appropriate proxy items, we might use existing items as proxies for the newly recommended items. In other cases, we included the item in the direct PE input database without any associated price. Although including the item without an associated price means that the item does not contribute to the calculation of the final PE RVU for particular services, it facilitates our ability to incorporate a price once we obtain information and are able to do so.
Generally speaking, our direct PE inputs do not include clinical labor minutes assigned to the service period because the cost of clinical labor during the service period for a procedure in the facility setting is not considered a resource cost to the practitioner since Medicare makes separate payment to the facility for these costs. We address proposed code-specific refinements to clinical labor in the individual code sections.
We note that the public use files for the PFS proposed and final rules for each year display the services subject to the MPPR lists on diagnostic cardiovascular services, diagnostic imaging services, diagnostic ophthalmology services, and therapy services. We also include a list of procedures that meet the definition of imaging under section 1848(b)(4)(B) of the Act, and therefore, are subject to the OPPS cap for the upcoming calendar year. The public use files for CY 2019 are available on the CMS website under downloads for the CY 2019 PFS final rule at
CPT code 10021 was identified as part of the OPPS cap payment proposal in CY 2014 (78 FR 74246-74248), and it was reviewed by the RUC for direct PE inputs only as part of the CY 2016 rule cycle. Afterwards, CPT codes 10021 and 10022 were referred to the CPT Editorial Panel to consider adding additional clarifying language to the code descriptors and to include bundled imaging guidance due to the fact that imaging had become typical with these services. In June 2017, the CPT Editorial Panel deleted CPT code 10022, revised CPT code 10021, and created nine new codes to describe fine needle aspiration procedures with and without imaging guidance. These ten codes were surveyed and reviewed for the October 2017 and January 2018 RUC meetings. Several imaging services were also reviewed along with the rest of the code family, although only CPT code 77021 was subject to a new survey.
For CY 2019, we proposed the RUC-recommended work RVU for seven of the ten codes in this family. Specifically, we proposed a work RVU of 0.80 for CPT code 10004 (Fine needle aspiration biopsy; without imaging guidance; each additional lesion), a work RVU of 1.00 for CPT code 10006 (Fine needle aspiration biopsy, including ultrasound guidance; each additional lesion), a work RVU of 1.81 for CPT code 10007 (Fine needle aspiration biopsy, including fluoroscopic guidance; first lesion), a work RVU of 1.18 for CPT code 10008 (Fine needle aspiration biopsy, including fluoroscopic guidance; each additional lesion), and a work RVU of
We disagreed with the RUC-recommended work RVU of 1.20 for CPT code 10021 (Fine needle aspiration biopsy; without imaging guidance; first lesion) and proposed a work RVU of 1.03 based on a direct crosswalk to CPT code 36440 (Push transfusion, blood, 2 years or younger). CPT code 36440 is a recently reviewed code with the same intraservice time of 15 minutes and 2 additional minutes of total time. In reviewing CPT code 10021, we noted that the recommended intraservice time is decreasing from 17 minutes to 15 minutes (12 percent reduction), and the recommended total time is decreasing from 48 minutes to 33 minutes (32 percent reduction); however, the RUC-recommended work RVU is only decreasing from 1.27 to 1.20, which is a reduction of just over 5 percent. Although we did not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should be appropriately reflected in decreases to work RVUs. In the case of CPT code 10021, we believed that it was more accurate to propose a work RVU of 1.03 based on a crosswalk to CPT code 36440 to account for these decreases in the surveyed work time.
We disagreed with the RUC-recommended work RVU of 1.63 for CPT code 10005 (Fine needle aspiration biopsy, including ultrasound guidance; first lesion) and proposed a work RVU of 1.46. Although we disagreed with the RUC-recommended work RVU, we concurred that the relative difference in work between CPT codes 10021 and 10005 is equivalent to the recommended interval of 0.43 RVUs. Therefore, we proposed a work RVU of 1.46 for CPT code 10005, based on the recommended interval of 0.43 additional RVUs above our proposed work RVU of 1.03 for CPT code 10021. The proposed increment of 0.43 RVUs above CPT code 10021 was also based on the use of two crosswalk codes: CPT code 99225 (Subsequent observation care, per day, for the evaluation and management of a patient, which requires at least 2 of 3 key components); and CPT code 99232 (Subsequent hospital care, per day, for the evaluation and management of a patient, which requires at least 2 of 3 key components). Both of these codes have the same intraservice time and 1 additional minute of total time as compared with CPT code 10005, and both crosswalk codes share a work RVU of 1.39.
We disagreed with the RUC-recommended work RVU of 2.43 for CPT code 10009 (Fine needle aspiration biopsy, including CT guidance; first lesion) and we proposed a work RVU of 2.26. Although we disagreed with the RUC-recommended work RVU, we concurred that the relative difference in work between CPT codes 10021 and 10009 is equivalent to the recommended interval of 1.23 RVUs. Therefore, we proposed a work RVU of 2.26 for CPT code 10009, based on the recommended interval of 1.23 additional RVUs above our proposed work RVU of 1.03 for CPT code 10021. The proposed use of the recommended increment from CPT code 10021 was also based on the use of a crosswalk to CPT code 74263 (Computed tomographic (CT) colonography, screening, including image postprocessing), another CT procedure with 38 minutes of intraservice time and 50 minutes of total time at a work RVU of 2.28.
We noted that the recommended work pool is increasing by approximately 20 percent for the Fine Needle Aspiration family as a whole, while the recommended work time pool for the same codes is only increasing by about 2 percent. Since time is defined as one of the two components of work, we believed that this indicated a discrepancy in the recommended work values. We do not believe that the recoding of the services in this family has resulted in an increase in their intensity, only a change in the way in which they will be reported, and therefore, we do not believe that it would serve the interests of relativity to propose the recommended work values for all of the codes in this family. We believe that, generally speaking, the recoding of a family of services should maintain the same total work pool, as the services themselves are not changing, only the coding structure under which they are being reported. We also noted that through the bundling of some of these frequently reported services, it is reasonable to expect that the new coding system will achieve savings via elimination of duplicative assumptions of the resources involved in furnishing particular servicers. For example, a practitioner will not be carrying out the full preservice work twice for CPT codes 10022 and 76942, but preservice times were assigned to both of the codes under the old coding. We believe the new coding assigns more accurate work times and thus reflects efficiencies in resource costs that existed regardless of how the services were previously reported.
For the direct PE inputs, we proposed to refine the clinical labor time for the “Prepare room, equipment and supplies” (CA013) activity to 3 minutes and to refine the clinical labor time for the “Confirm order, protocol exam” (CA014) activity to 0 minutes for CPT code 77021. This code did not previously have clinical labor time assigned for the “Confirm order, protocol exam” clinical labor task, and we do not have any reason to believe that the services being furnished by the clinical staff have changed, only the way in which this clinical labor time has been presented on the PE worksheets. We also noted that there is no effect on the total clinical labor direct costs in these situations, since the same 3 minutes of clinical labor time is still being furnished. We also proposed to refine the equipment times in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on our proposals involving the Fine Needle Aspiration family of codes.
In the interest of providing transparency, we are including Table 12 with our work pool comparison for the Fine Needle Aspiration code family.
We continue to believe that the RUC-recommended work pool is increasing by approximately 20 percent for the Fine Needle Aspiration family as a whole, and that this percentage increase suggests that CPT codes 10021, 10005, and 10009 are more accurately valued at the CMS proposed work RVUs.
After consideration of the public comments, we are finalizing the work RVUs and direct PE inputs for all of the codes in the Fine Needle Aspiration family as proposed.
CPT code 11755 (Biopsy of nail unit (
We disagreed with the recommended value and proposed a work RVU of 1.08 for CPT code 11755 based on the survey 25th percentile value. We noted that the recommended intraservice time for CPT code 11755 is decreasing from 25 minutes to 15 minutes (40 percent reduction), and the recommended total time for CPT code 11755 is decreasing from 55 minutes to 39 minutes (29 percent reduction); however, the recommended work RVU is only decreasing from 1.31 to 1.25, which is a reduction of less than 5 percent. Although we did not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should be reflected in decreases to work RVUs. In the case of CPT code 11755, we believed that it would be more accurate to propose the survey 25th percentile work RVU than the survey median to account for these decreases in the surveyed work time.
The proposed work RVU of 1.08 is also based on a crosswalk to CPT code 11042 (Debridement, subcutaneous tissue (includes epidermis and dermis, if performed); first 20 sq cm or less), which has a work RVU of 1.01, the same intraservice time of 15 minutes, and a similar total time of 36 minutes. We also noted that, generally speaking, working with extremities like nails tends to be less intensive in clinical terms than other services, especially as compared to surgical procedures. We believe that
We proposed to refine the equipment times in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on our proposals involving CPT code 11755.
After consideration of the public comments, we are finalizing the RUC-recommended work RVU of 1.25 for CPT code 11755. We are finalizing the direct PE inputs for this code as proposed.
In CY 2016, CPT codes 11100 (Biopsy of skin, subcutaneous tissue and/or mucous membrane (including simple closure), unless otherwise listed; single lesion) and 11101 (Biopsy of skin, subcutaneous tissue and/or mucous membrane (including simple closure), unless otherwise listed; each separate/additional lesion) were identified as potentially misvalued using a high expenditure services screen across specialties with Medicare allowed charges of $10 million or more. Prior to the January 2016 RUC meeting, the specialty society notified the RUC that its survey data displayed a bimodal distribution of responses with more outliers than usual. The RUC referred CPT codes 11100 and 11101 to the CPT Editorial Panel. In February 2017, the CPT Editorial Panel deleted these two codes and created six new codes for primary and additional biopsy based on the thickness of the sample and the technique utilized.
For CY 2019, we proposed the RUC-recommended work RVUs for five of the six codes in the family. We proposed a work RVU of 0.66 for CPT code 11102 (Tangential biopsy of skin, (
For CPT code 11103 (Tangential biopsy of skin, (
For the direct PE inputs, we proposed to remove the 2 minutes of clinical labor time for the “Review home care instructions, coordinate visits/prescriptions” (CA035) activity for CPT codes 11102, 11104, and 11106. These codes are typically billed with a same day E/M service, and we believe that it would be duplicative to assign clinical labor time for reviewing home care instructions given that this task would typically be done during the same day E/M service. We also proposed to refine the equipment times in accordance with our standard equipment time formulas.
We proposed to refine the quantity of the “gown, staff, impervious” (SB024) and the “mask, surgical, with face shield” (SB034) supplies from 2 to 1 for CPT codes 11102, 11104, and 11106. We proposed to remove one gown and one surgical mask from these codes as duplicative since these supplies are also included within the surgical instrument cleaning pack (SA043). We also proposed to remove all of the supplies in the three add-on procedures (CPT codes 11103, 11105, and 11107) that were not contained in the previous add-on procedure for this family, CPT code 11101. We do not believe that the use of these supplies would be typical for the “each additional lesion” add-on codes, as these supplies are all included in the base codes and are not currently utilized in CPT code 11101. We noted that the recommended direct PE costs for the three new add-on codes represent an increase of approximately 500 percent from the direct PE costs for CPT code 11101, and believe that this is largely due to the addition of these new supplies.
The following is a summary of the public comments we received on our proposals involving the Skin Biopsy family of codes.
After consideration of the public comments, we are finalizing the RUC-recommended work RVUs for all of the codes in the Skin Biopsy family. We are finalizing the direct PE inputs as proposed, with the exception of the supplies from the three add-on procedures (CPT codes 11103, 11105, and 11107) as detailed above.
CPT code 20551 (Injection(s); single tendon origin/insertion) was identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. For CY 2019, we proposed the RUC-recommended work RVU of 0.75 for CPT code 20551.
We proposed to maintain the current work RVU for many of the CPT codes identified as potentially misvalued on the screen of 0-day global services reported with an E/M visit 50 percent of the time or more. We noted that regardless of the proposed work valuations for individual codes, which may or may not retain the same work RVU, we continue to have reservations about the valuation of 0-day global services that are typically billed with a separate E/M service with the use of Modifier 25 (indicating that a significant and separately identifiable E/M service was provided on the same day). As we stated in the CY 2017 PFS final rule (81 FR 80204), we continue to believe that the routine billing of separate E/M services in conjunction with a particular code may indicate a possible problem with the valuation of the code bundle, which is intended to include all the routine care associated with the service. We will continue to consider additional ways to address the appropriate valuation for these services.
For the direct PE inputs, we proposed to remove the clinical labor time for the “Provide education/obtain consent” (CA011) and the “Review home care instructions, coordinate visits/prescriptions” (CA035) activities for CPT code 20551. This code is typically billed with a same day E/M service, and we believe that it will be duplicative to assign clinical labor time for obtaining consent or reviewing home care instructions given that these tasks will typically be done during the same day E/M service. We also proposed to refine the equipment times in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on our proposals involving CPT code 20551.
After consideration of the public comments, we are finalizing our proposal to maintain the current work RVU for CPT code 20551. We are finalizing the direct PE inputs with the refinements detailed above.
In February 2017, the CPT Editorial Panel created three new codes to describe allografts. These codes were designated as add-on codes and revised to more accurately describe the structural allograft procedures they represent. For CY 2019, we proposed the RUC-recommended work RVUs for all three codes. We proposed a work RVU of 13.01 for CPT code 20932 (Allograft, includes templating, cutting, placement and internal fixation when performed; osteoarticular, including articular surface and contiguous bone), a work RVU of 11.94 for CPT code 20933 (Allograft, includes templating, cutting, placement and internal fixation when performed; hemicortical intercalary, partial (
These three new codes are all facility-only procedures with no recommended direct PE inputs.
We did not receive any comments on our proposals involving the Structural Allograft family of codes. Therefore we are finalizing the work RVUs for the codes in this family as proposed.
CPT code 27370 (Injection of contrast for knee arthrography) repeatedly appeared on high volume growth screens between 2008 and 2016, and the RUC expressed concern that the high volume growth for this procedure was likely due to its being reported incorrectly as arthrocentesis or aspiration. In June 2017, the CPT Editorial Panel deleted CPT code 27370 and replaced it with a new code, 27369, to report injection procedure for knee arthrography or enhanced CT/MRI knee arthrography.
The RUC recommended a work RVU of 0.96 for CPT code 27369, which is identical to the work RVU for CPT code 27370 (Injection of contrast for knee arthrography). The RUC's recommendation is based on key reference service, CPT code 23350 (Injection procedure for shoulder arthrography or enhanced CT/MRI shoulder arthrography), with identical intraservice time (15 minutes) and total time (28 minutes) as the new CPT code and a work RVU of 1.00. The RUC notes that its recommendation is lower than the 25th percentile from the survey results, but that the work described by the service should be valued identically with the CPT code being replaced. We disagreed with the RUC's recommended work RVU for CPT code 27369. Both the total (28 minutes) and intraservice (15 minutes) times for the new CPT code are considerably lower than the deleted CPT code 27370. Based on the reduced times and the projected work RVU from the reverse building block methodology (0.60 work RVUs), we believe this CPT code should be valued at 0.77 work RVUs, supported by a crosswalk to CPT code 29075 (Application, cast; elbow to finger (short arm)), with total time of 27 minutes and intraservice time of 15 minutes. Therefore, we proposed a work RVU of 0.77 for CPT code 27369.
For the direct PE inputs, we proposed to refine the clinical labor time for the “Prepare room, equipment and supplies” (CA013) activity to 3 minutes and to refine the clinical labor time for the “Confirm order, protocol exam” (CA014) activity to 0 minutes. The predecessor code for 27369, CPT code 27370, did not have clinical labor time assigned for the “Confirm order, protocol exam” clinical labor task, and we do not have any reason to believe that the services being furnished by the clinical staff have changed, only the way in which this clinical labor time has been presented on the PE worksheets. We also noted that there is no effect on the total clinical labor direct costs in these situations, since the same 3 minutes of clinical labor time is still being furnished.
We proposed to remove the clinical labor time for the “Scan exam documents into PACS. Complete exam in RIS system to populate images into work queue” (CA032) activity. CPT code 27369 does not include a PACS workstation among the recommended equipment, and the predecessor code 27370 did not previously include time for this clinical labor activity. We believe that data entry activities such as this task would be classified as indirect PE, as they are considered administrative activities and are not individually allocable to a particular patient for a particular service. We also proposed to refine the equipment times in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on our proposals involving CPT code 27369.
After consideration of the public comments, we are finalizing the direct PE inputs for CPT code 27369 as proposed.
CPT code 29105 (Application of long arm splint (shoulder to hand)) was identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. For CY 2019, we proposed the RUC-recommended work RVU of 0.80 for CPT code 29105. For the direct PE inputs, we proposed to refine the equipment times in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on our proposals involving CPT code 29105.
After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for CPT code 29105 as proposed.
CPT codes 29540 (Strapping; ankle and/or foot) and 29550 (Strapping; toes) were identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. For CY 2019, we proposed the HCPAC-recommended work RVU of 0.39 for CPT code 29540 and the HCPAC-recommended work RVU of 0.25 for CPT code 29550.
For the direct PE inputs, we proposed to refine the clinical labor time for the “Provide education/obtain consent” (CA011) activity from 3 minutes to 2 minutes for both codes, as this is the standard clinical labor time assigned for patient education and consent. We also proposed to remove the 2 minutes of clinical labor time for the “Review home care instructions, coordinate visits/prescriptions” (CA035) activity for both codes. CPT codes 29540 and 29550 are both typically billed with a same day E/M service, and we believe that it would be duplicative to assign clinical labor time for reviewing home care instructions given that this task would typically be done during the same day E/M service. We also proposed to refine the equipment times in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on our proposals involving the Strapping Lower Extremity family of codes.
After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for CPT codes 29540 and 29550 as proposed.
CPT code 31623 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with
For the direct PE inputs, we proposed to refine the clinical labor time for the “Complete post-procedure diagnostic forms, lab and x-ray requisitions” (CA027) activity from 4 minutes to 2 minutes for CPT codes 31623 and 31624. Two minutes is the standard time, as well as the current time for this clinical labor activity, and we have no reason to believe that the time to perform this task has increased since the codes were last reviewed. We did not receive any explanation in the recommendations as to why the time for this activity would be doubling over the current values. We also proposed to refine the equipment times in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on our proposals involving the Bronchoscopy family of codes.
After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for CPT codes 31623 and 31624 as proposed.
In September 2017, the CPT Editorial Panel created a code to describe pulmonary wireless sensor implantation and another code for remote care management of patients with an implantable, wireless pulmonary artery pressure sensor monitor. For CY 2019, we proposed the RUC-recommended work RVU of 6.00 for CPT code 33289 (Transcatheter implantation of wireless pulmonary artery pressure sensor for long term hemodynamic monitoring, including deployment and calibration of the sensor, right heart catheterization, selective pulmonary catheterization, radiological supervision and interpretation, and pulmonary artery angiography, when performed), and the RUC-recommended work RVU of 0.70 for CPT code 93264 (Remote monitoring of a wireless pulmonary artery pressure sensor for up to 30 days including at least weekly downloads of pulmonary artery pressure recordings, interpretation(s), trend analysis, and report(s) by a physician or other qualified health care professional).
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on our proposals involving the Pulmonary Wireless Pressure Sensor Services family of codes.
After consideration of the public comments, we are finalizing the RUC-recommended work RVUs for CPT codes 33289 and 93264 as proposed.
In February 2017, the CPT Editorial Panel created two new codes replacing cardiac event recorder codes to reflect new technology. For CY 2019, we proposed the RUC-recommended work RVU of 1.53 for CPT code 33285 (Insertion, subcutaneous cardiac rhythm monitor, including programming) and the RUC-recommended work RVU of 1.50 for CPT code 33286 (Removal, subcutaneous cardiac rhythm monitor).
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on our proposals involving the Cardiac Event Recorder Procedures family of codes.
After consideration of the public comments, we are finalizing the RUC-recommended work RVUs and direct PE inputs for CPT codes 33285 and 33286 as proposed.
In September 2017, the CPT Editorial Panel created one new code to combine the efforts of aortic valve and root replacement with subvalvular left ventricular outflow tract enlargement to allow for an unobstructed left ventricular outflow tract.
For CY 2019, we proposed the RUC-recommended work RVU of 64.00 for CPT code 33440 (Replacement, aortic valve; by translocation of autologous pulmonary valve and transventricular aortic annulus enlargement of the left ventricular outflow tract with valved conduit replacement of pulmonary valve (Ross-Konno procedure)). When this code is re-reviewed in a few years as part of the new technology screen, we look forward to receiving new recommendations on the whole family, including the related Ross and Konno procedures (CPT codes 33413 and 33412 respectively) that were used as references for CPT code 33440.
For the direct PE inputs, we proposed to refine the preservice clinical labor times to match our standards for 90-day global procedures. We proposed to refine the clinical labor time for the “Coordinate pre-surgery services (including test results)” (CA002) activity from 25 minutes to 20 minutes, to refine the clinical labor time for the “Schedule space and equipment in facility” (CA003) activity from 12 minutes to 8 minutes, and to refine the clinical labor time for the “Provide pre-service education/obtain consent” (CA004) activity from 26 minutes to 20 minutes. We also proposed to add 15 minutes of clinical labor time for the “Perform regulatory mandated quality assurance activity (pre-service)” (CA008) activity. We agreed with the recommendation that the total preservice clinical labor
The following is a summary of the public comments we received on our proposals involving CPT code 33440.
After consideration of the public comments, we are finalizing the work RVUs and direct PE inputs for CPT code 33440 as proposed.
At the September 2017 CPT Editorial Panel meeting, the Panel created one new add-on code to report hemi-aortic arch graft replacement. For CY 2019, we proposed the RUC-recommended work RVU of 19.74 for CPT code 33866 (Aortic hemiarch graft including isolation and control of the arch vessels, beveled open distal aortic anastomosis extending under one or more of the arch vessels, and total circulatory arrest or isolated cerebral perfusion). CPT code 33866 is a facility-only procedure with no recommended direct PE inputs.
The following is a summary of the public comments we received on our proposals involving CPT code 33866.
After consideration of the public comments received, we are finalizing the RUC-recommended work RVUs for CPT code 33866 as proposed.
At the September 2017 CPT Editorial Panel meeting, the Panel replaced the five leadless pacemaker services, Category III codes, with the addition of two new CPT codes to report transcatheter leadless pacemaker procedures and revised five codes to include evaluation and interrogation services of leadless pacemaker systems.
For CPT code 33274 (Transcatheter insertion or replacement of permanent leadless pacemaker, right ventricular, including imaging guidance (
Therefore, we proposed to crosswalk CPT code 33274 to CPT code 33207 at the same work RVU of 7.80. The proposed work RVU was also supported through a reference crosswalk to CPT code 38542 (Dissection, deep jugular node(s)), which has 60 minutes of intraservice time, 198 minutes of total time, and a work RVU of 7.95. We believe that our proposed work RVU of
For CPT code 33275 (Transcatheter removal of permanent leadless pacemaker, right ventricular), we disagreed with the RUC-recommended work RVU of 9.56 and we proposed a work RVU of 8.59. Although we disagreed with the RUC-recommended work RVU, we concurred that the relative difference in work between CPT codes 33274 and 33275 is equivalent to the recommended interval of 0.79 RVUs. Therefore, we proposed a work RVU of 8.59 for CPT code 33275, based on the recommended interval of 0.79 additional RVUs above our proposed work RVU of 7.80 for CPT code 33274. We also noted that our proposed work RVU for CPT code 33275 situates it approximately halfway between the two reference codes from the survey, with CPT code 33270 (Insertion or replacement of permanent subcutaneous implantable defibrillator system, with subcutaneous electrode, including defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing for arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters, when performed) having an intraservice time of 90 minutes and a work RVU of 9.10, and CPT code 33207 having an intraservice time of 60 minutes and a work RVU of 7.80. CPT code 33275 has a surveyed intraservice time of 75 minutes and nearly splits the difference between them at our proposed work RVU of 8.59.
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on our proposals involving the Leadless Pacemaker Procedures family of codes.
We also disagree with the commenters that CPT code 33274 has so much additional intensity and complexity as compared to key reference CPT code 33207 that they should be valued at the same work RVU of 8.77. We note that the RUC's research panel selected preservice package 3, “a straightforward patient and a difficult procedure” for CPT code 33274. We believe this indicates that the patient population for CPT code 33274 would not be unusually difficult or complex as suggested by the commenters. We further note that the summary of recommendations for CPT code 33274 states that these patients are typically sent home from the facility the next day. In contrast, reference CPT code 33207 includes a full hospital inpatient day of post procedure care associated with CPT code 99322, as well as a full discharge visit instead of half of a discharge visit. We believe that this further suggests that the patient population for CPT code 33274 would not be more difficult or complex than the patient population for CPT code 33207. As we stated in the proposed rule, we continue to acknowledge that CPT code 33274 is a more intense procedure than CPT code 33207, but we do not believe that it should be valued almost a full RVU higher than the reference code given the fewer visits in the global period and the lower surveyed work time.
After consideration of the public comments, we are finalizing the work RVUs and direct PE inputs for the codes in the Leadless Pacemaker Procedures family as proposed.
In CY 2016, CPT code 36569 (Insertion of peripherally inserted central venous catheter (PICC), without subcutaneous port or pump, without imaging guidance; age 5 years or older) was identified as potentially misvalued using a high expenditure services screen across specialties with Medicare allowed charges of $10 million or more. CPT code 36569 is typically reported with CPT codes 76937 (Ultrasound guidance for vascular access requiring ultrasound evaluation of potential access sites, documentation of selected vessel patency, concurrent real-time ultrasound visualization of vascular needle entry, with permanent recording and reporting) and 77001 (Fluoroscopic guidance for central venous access device placement, replacement (catheter only or complete), or removal) and was referred to the CPT Editorial Panel to have the two common imaging codes bundled into the code. In September 2017, the CPT Editorial Panel revised CPT codes 36568 (Insertion of peripherally inserted central venous catheter (PICC), without subcutaneous port or pump; younger than 5 years of age), 36569 and 36584 (Replacement, complete, of a peripherally inserted central venous catheter (PICC), without subcutaneous port or pump, through same venous access, including all imaging guidance, image documentation, and all associated radiological supervision and interpretation required to perform the replacement) and created two new CPT codes to specify the insertion of peripherally inserted central venous catheter (PICC), without subcutaneous port or pump, including all imaging guidance, image documentation, and all associated radiological supervision and interpretation required to perform the insertion.
For CY 2019, we proposed the RUC-recommended work RVU for two of the CPT codes in the family. We proposed the RUC-recommended work RVU of 2.11 for CPT code 36568 and the RUC-recommended work RVU of 1.90 for CPT code 36569.
For CPT code 36572 (Insertion of peripherally inserted central venous catheter (PICC), without subcutaneous port or pump, including all imaging guidance, image documentation, and all associated radiological supervision and interpretation required to perform the insertion; younger than 5 years of age), we disagreed with the RUC-recommended work RVU of 2.00 and proposed a work RVU of 1.82 based on a direct crosswalk to CPT code 50435 (Exchange nephrostomy catheter, percutaneous, including diagnostic nephrostogram and/or ureterogram when performed, imaging guidance (
In the case of CPT code 36572, we believed that it would be more accurate to propose a work RVU of 1.82 based on a crosswalk to CPT code 50435 to better fit with the recommended work RVUs for CPT codes 36568 and 36569. The proposed work valuation was also based on the use of three additional crosswalk codes: CPT code 32554 (Thoracentesis, needle or catheter, aspiration of the pleural space; without imaging guidance), CPT code 43198 (Esophagoscopy, flexible, transnasal; with biopsy, single or multiple), and CPT code 64644 (Chemodenervation of one extremity; 5 or more muscles). All of these codes were recently reviewed with similar intensity, intraservice time, and total time values, and all three of them share a work RVU of 1.82.
For CPT code 36573 (Insertion of peripherally inserted central venous catheter (PICC), without subcutaneous port or pump, including all imaging guidance, image documentation, and all associated radiological supervision and interpretation required to perform the insertion; age 5 years or older), we disagreed with the RUC-recommended work RVU of 1.90 and proposed a work RVU of 1.70 based on maintaining the current work RVU of CPT code 36569. In our review of CPT code 36573, we were again concerned about the possibility that the recommended work RVU of 1.90 could create a rank order anomaly in terms of intensity with the other codes in the family. We noted that the recommended intraservice time for CPT code 36573 as compared to CPT code 36569, the most similar code in the family, was decreasing from 27 minutes to 15 minutes (45 percent), and the recommended total time was decreasing from 60 minutes to 40 minutes (33 percent); however, the RUC-recommended work RVU was exactly the same for these two codes at 1.90. Although we did not imply that the decreases in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should be reflected in decreases to work RVUs.
In the case of CPT code 36573, we believed that it would be more accurate to propose a work RVU of 1.70 based on maintaining the current work RVU of CPT code 36569. These two CPT codes describe the same procedure done with (CPT code 36573) and without (CPT code 35659) imaging guidance and radiological supervision and interpretation. Because the inclusion of the imaging described by CPT code 36573 has now become the typical case for this service, we believe that it is more accurate to maintain the current work RVU of 1.70 as opposed to
For CPT code 36584, we disagreed with the RUC-recommended work RVU of 1.47 and proposed a work RVU of 1.20 based on maintaining the current work RVU. We noted that the recommended intraservice time for CPT code 36584 was decreasing from 15 minutes to 12 minutes (20 percent reduction), and the recommended total time was decreasing from 45 minutes to 34 minutes (25 percent reduction); however, the recommended work RVU was increasing from 1.20 to 1.47, an increase of approximately 23 percent. Although we did not imply that the decreases in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believed that since the two components of work are time and intensity, significant decreases in time should be reflected in decreases to work RVUs. We were especially concerned when the recommended work RVU is increasing despite survey results indicating that the work time is decreasing due to a combination of improving technology and greater efficiencies in practice patterns.
In the case of CPT code 36584, we believed that it would be more accurate to propose a work RVU of 1.20 based on maintaining the current work RVU for the code. Because the inclusion of the imaging has now become the typical case for this service, we believed that it was more accurate to maintain the current work RVU of 1.20 as opposed to increasing the work RVU to 1.47, especially considering that the new surveyed work time for CPT code 36584 was decreasing from the current work time. The proposed work RVU of 1.20 was also based on a crosswalk to CPT code 40490 (Biopsy of lip), which has the same total time of 34 minutes and slightly higher intraservice time at a work RVU of 1.22.
We noted that the RUC-recommended work pool was increasing by approximately 68 percent for the PICC Line Procedures family as a whole, while the RUC-recommended work time pool for the same codes was only increasing by about 22 percent. Since time is defined as one of the two components of work, we believe that this indicated a discrepancy in the recommended work values. We do not believe that the recoding of the services in this family has resulted in an increase in their intensity, only a change in the way in which they will be reported, and therefore, we did not believe that it would serve the interests of relativity to propose the RUC-recommended work values for all of the codes in this family. We believe that, generally speaking, the recoding of a family of services should maintain the same total work pool, as the services themselves are not changing, only the coding structure under which they are being reported. We also noted that, through the bundling of some of these frequently reported services, it is reasonable to expect that the new coding system will achieve savings via elimination of duplicative assumptions of the resources involved in furnishing particular servicers. For example, a practitioner would not be carrying out the full preservice work three times for CPT codes 36568, 76937, and 77001, but preservice times were assigned to all of the codes under the old coding. We believed the new coding assigns more accurate work times and thus reflects efficiencies in resource costs that existed but were not reflected in the services as they were previously reported.
For the direct PE inputs, we proposed to refine the clinical labor time for the “Prepare, set-up and start IV, initial positioning and monitoring of patient” (CA016) activity from 4 minutes to 2 minutes for CPT codes 36572 and 36573. We noted that the two reference codes for the two new codes, CPT codes 36568 and 36569, currently have 2 minutes assigned for this activity, and CPT code 36584 also has a recommended 2 minutes assigned to this same activity. We did not agree that the patient positioning would take twice as long for CPT codes 36572 and 36573 as compared to the rest of the family, and therefore proposed to refine both of them to the same 2 minutes of clinical labor time. We also proposed to refine the equipment times in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on our proposals involving the PICC Line Procedures family of codes.
We also do not agree that CPT codes 36568 and 36572 have significantly different patient populations and different service intensity. As we stated in the proposed rule, we do not believe that the revised coding of the services in this family has changed the services themselves or resulted in an increase in their intensity, only changed in the way in which they will be reported under the new coding. CPT code 36572 is a new code resulting from the bundling together of CPT code 36568 with imaging guidance. The same services that were previously reported through a combination of CPT codes 36568 and 76397 will now be reported under CPT code 36572. Given that 90 percent of the services that were formerly reported using CPT code 36568 will now be reported using CPT code 36572, we do not agree that these codes represent significantly different patient populations.
After consideration of the public comments, we are finalizing the work RVUs for the codes in the PICC Line Procedures family as proposed. After considering public comments, we are not finalizing our proposed direct PE refinements, and we are instead finalizing the RUC-recommended direct PE inputs for all five codes.
In September 2017, the CPT Editorial Panel created a new code to describe biopsy or excision of inguinofemoral node(s). A parenthetical was added to CPT codes 56630 (Vulvectomy, radical, partial) and 56633 (Vulvectomy, radical, complete) to instruct separate reporting of CPT code 38531 with radical
CPT code 38531 (Biopsy or excision of lymph node(s); open, inguinofemoral node(s)) is a new CPT code describing a lymph node biopsy without complete lymphadenectomy. The RUC recommended a work RVU of 6.74 for CPT code 38531, with 223 minutes of total time and 65 minutes of intraservice time. We proposed the RUC-recommended work RVU of 6.74 for CPT code 38531. However, we were concerned that this CPT code is described as having a 10-day global period. The two CPT codes that are often reported together with this code, CPT codes 56630 and 56633, are both 90-day global codes. In addition, CPT code 38531 has a discharge visit and two follow up visits in the global period. This is consistent with the number of postoperative visits typically associated with 90-day global codes. Therefore, we proposed to assign a 90-day global indicator for CPT code 38531 rather than the 10-day global time period reflected in the RUC recommendation.
We did not propose any direct PE refinements for this code family.
After consideration of the public comments, we are finalizing a work RVU of 6.74 for CPT code 38531 as proposed.
CPT code 38792 (Injection procedure; radioactive tracer for identification of sentinel node) was identified as potentially misvalued on a screen of codes with a negative intraservice work per unit of time (IWPUT), with 2016 estimated Medicare utilization over 10,000 for RUC reviewed codes and over 1,000 for Harvard valued and CMS/Other source codes. For CY 2019, we proposed the RUC-recommended work RVU of 0.65 for CPT code 38792.
For the direct PE inputs, we proposed to refine the clinical labor time for the “Prepare room, equipment and supplies” (CA013) activity to 3 minutes and to refine the clinical labor time for the “Confirm order, protocol exam” (CA014) activity to 0 minutes. CPT code 38792, as well as its alternate reference code, CPT code 78300 (Bone and/or joint imaging; limited area), did not previously have clinical labor time assigned for the “Confirm order, protocol exam” clinical labor task, and we do not have any reason to believe that the services being furnished by the clinical staff have changed, only the way in which this clinical labor time has been presented on the PE worksheets. We also note that there is no effect on the total clinical labor direct costs in these situations, since the same 3 minutes of clinical labor time is still being furnished. We also proposed to refine the equipment times in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on our proposals involving CPT code 38792.
After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for CPT code 38792 as proposed.
CPT code 43760 (Change of gastrostomy tube, percutaneous, without imaging or endoscopic guidance) was identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. It was surveyed for the April 2017 RUC meeting and recommendations for work and direct PE inputs were submitted to CMS. However, the RUC also noted that because the data for CPT code 43760 were bimodal, it might be appropriate to consider changes in the CPT descriptors to better differentiate physician work. In September 2017, the CPT Editorial Panel deleted CPT code 43760 and will use two new CPT codes, CPT codes 43762 and 43763, which describe replacement of gastrostomy tube, with and without revision of gastrostomy tract, respectively. (See discussion of these codes below.) Therefore, we did not propose work or direct PE values for CPT code 43760.
Due to the impending deletion of CPT code 43760, we received no comments on this code.
In September 2017, the CPT Editorial Panel created two new codes that describe replacement of gastrostomy tube, with and without revision of gastrostomy tract, respectively. These two new codes were surveyed for the January 2018 RUC meeting and recommendations for work and direct PE inputs were submitted to CMS.
We proposed a work RVU of 0.75 for CPT code 43762 (Replacement of gastrostomy tube, percutaneous, includes removal, when performed, without imaging or endoscopic guidance; not requiring revision of gastrostomy tract.) and a work RVU of 1.41 for CPT code 43763 (Replacement of gastrostomy tube, percutaneous, includes removal, when performed, without imaging or endoscopic guidance; requiring revision of gastrostomy tract.), consistent with the RUC's recommendations for these new CPT codes.
For the direct PE inputs, we proposed to refine the equipment times in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on our proposals involving the codes in the Gastrostomy Tube Replacement code family.
After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for the codes in the as Gastrostomy Tube Replacement code family as proposed.
CPT code 45300 (Proctosigmoidoscopy, rigid; diagnostic, with or without collection of specimen(s) by brushing or washing (separate procedure)) was identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years, with Medicare utilization greater than 20,000. For CY 2019, we proposed the RUC-recommended work RVU of 0.80 for CPT code 45300.
For the direct PE inputs, we proposed to refine the equipment times in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on our proposals involving CPT code 45300.
After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for CPT code 45300 as proposed.
CPT code 46500 (Injection of sclerosing solution, hemorrhoids) was identified as potentially misvalued on a screen of codes with a negative intraservice work per unit of time (IWPUT), with 2016 estimated Medicare utilization over 10,000 for RUC reviewed codes and over 1,000 for Harvard valued and CMS/Other source codes.
For CPT code 46500, we disagreed with the RUC-recommended work RVU of 2.00 and we proposed a work RVU of 1.74 based on a direct crosswalk to CPT code 68811 (Probing of nasolacrimal duct, with or without irrigation; requiring general anesthesia). This crosswalk code is another recently-reviewed 10-day global code with the same 10 minutes of intraservice time and slightly higher total time. When CPT code 46500 was previously reviewed as described in the CY 2016 PFS final rule with comment period (80 FR 70963), we finalized a proposal to reduce the work RVU from 1.69 to 1.42, which reduced the work RVU by the same ratio as the reduction in the total work time. In light of the additional evidence provided by this new survey, we agree that the work RVU should be increased from the current value of 1.42. However, we believe that our proposed work RVU of 1.74 based on a crosswalk to CPT code 68811 is more accurate than the RUC-recommended work RVU of 2.00.
In the most recent survey of CPT code 46500, the intraservice work time remained unchanged at 10 minutes while the total time increased by only 2 minutes, increasing from 59 minutes to 61 minutes (3 percent). However, the RUC-recommended work RVU is increasing from 1.42 to 2.00, an increase of 41 percent, and also an increase of 19 percent over the historic value of 1.69 for CPT code 46500. Although we did not imply that the increase in time as reflected in survey values must equate to a one-to-one or linear increase in the valuation of work RVUs, we believe that since the two components of work are time and intensity, minimal increases in surveyed work time typically should not be reflected in disproportionately large increases to work RVUs. In the case of CPT code 46500, we believe that our crosswalk to CPT code 68811 at a work RVU of 1.74 more accurately maintains relativity with other 10-day global codes on the PFS. We also noted that the 3 percent increase in surveyed work time for CPT code 46500 matches a 3 percent increase in the historic work RVU of the code, from 1.69 to 1.74. Therefore, we proposed a work RVU of 1.74 for CPT code 46500 based on the aforementioned crosswalk.
For the direct PE inputs, we proposed to remove 10 minutes of clinical labor time for the “Assist physician or other qualified healthcare professional—directly related to physician work time (100%)” (CA018) activity. This clinical labor time is listed twice in the recommendations along with a statement that although the clinical labor has not changed from prior reviews, time for both clinical staff members was inadvertently not included in the previous spreadsheets. We appreciated this notification in the recommendations, and therefore, we requested more information about why the clinical labor associated with this additional staff member was left out for previous reviews. We were particularly interested in knowing what activities the additional staff member would be undertaking during the procedure. We proposed to remove the clinical labor associated with this additional clinical staff member pending the receipt of additional information. We also proposed to remove 1 impervious staff gown (SB027), 1 surgical mask with face shield (SB034), and 1 pair of shoe covers (SB039) pending more information about the additional clinical staff member.
We proposed to remove the clinical labor time for the “Review home care instructions, coordinate visits/prescriptions” (CA035) activity. CPT code 46500 is typically billed with a same day E/M service, and we believe that it would be duplicative to assign clinical labor time for reviewing home care instructions given that this task would typically be done during the same day E/M service. We also proposed to refine the equipment times in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on our proposals involving CPT code 46500.
After consideration of the public comments, we are finalizing the work RVU for CPT code 46500 as proposed. We are finalizing the RUC-recommended direct PE inputs for this code, with the exception of our refinement to the CA035 clinical labor activity and standard equipment time refinements as detailed above.
In October 2016, CPT code 49422 (Removal of tunneled intraperitoneal catheter) was identified as a site of service anomaly because Medicare data from 2012-2014 indicated that it was performed less than 50 percent of the time in the inpatient setting, yet it included inpatient hospital E/M services within the 10-day global period. The code was resurveyed using a 0-day global period for the April 2017 RUC meeting. For CY 2019, we proposed the RUC-recommended work RVU of 4.00 for CPT code 49422.
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on our proposals involving CPT code 49422.
After consideration of the public comments, we are finalizing the RUC-recommended work RVU and direct PE inputs for CPT code 49422 as proposed.
In October 2014, the CPT Editorial Panel deleted 6 codes and created 12 new codes to describe genitourinary catheter procedures and bundle inherent imaging services. In January 2015, the specialty societies indicated that CPT code 50395 (Introduction of guide into renal pelvis and/or ureter with dilation to establish nephrostomy tract, percutaneous), which was identified as part of the family, would be referred to the CPT Editorial Panel to clear up any confusion with overlap in physician work with CPT code 50432 (Placement of nephrostomy catheter, percutaneous, including diagnostic nephrostogram and/or ureterogram when performed, imaging guidance (
The specialty society surveyed the new CPT code 50436 (Dilation of existing tract, percutaneous, for an endourologic procedure including imaging guidance (
We disagreed with the RUC that the work RVU for this CPT code should be the same as the CPT code being deleted. Survey respondents indicated that the total time for completing the service described by the new CPT code is nearly 30 minutes less than the existing CPT code, even though imaging guidance was described as part of the procedure. We also noted that the reference CPT codes both have substantially higher total and intraservice times than CPT code 50436. We considered a number of parameters to arrive at our proposed work RVU of 2.78, supported by a crosswalk to CPT code 31646 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with therapeutic aspiration of tracheobronchial tree, subsequent, same hospital stay). We examined the intraservice time ratio for the new CPT code in relation to the combination of CPT codes that the service represents and found that this would support a work RVU of 2.55. We also calculated the intraservice time ratio for the new CPT code in relation to each of the two
The specialty society also surveyed the new CPT code 50437 (Dilation of existing tract, percutaneous, for an endourologic procedure including imaging guidance (
We did not agree with the RUC's recommended work RVU because we believed that the intraservice time for this CPT code should reflect the survey median rather than the 75th percentile. There is no indication that the additional work of imaging guidance was systematically excluded by survey respondents when estimating the time needed to furnish the service. Therefore, we proposed to reduce the intraservice time for CPT code 50437 from the RUC- recommended 60 minutes to the survey median time of 45 minutes. We noted that this is still 15 minutes more than the intraservice time for CPT code 50436, primarily for the provider to introduce the guidewire into the renal pelvis and/or ureter. We welcomed comments about the amount of time needed to furnish this procedure.
With the revised intraservice time of 45 minutes and a total time of 85 minutes, we believed that the RUC-recommended work RVU for this CPT code is overstated. When we applied the increment between the RUC-recommended values for between CPT codes 50436 and 50437 (2.07 work RVUs) in addition to our proposed work RVU for CPT code 50436, we estimated that this CPT code was more accurately represented by a work RVU of 4.83. This value is supported by a crosswalk to CPT code 36902 (Introduction of needle(s) and/or catheter(s), dialysis circuit, with diagnostic angiography of the dialysis circuit, including all direct puncture(s) and catheter placement(s), injection(s) of contrast, all necessary imaging from the arterial anastomosis and adjacent artery through entire venous outflow including the inferior or superior vena cava, fluoroscopic guidance, radiological supervision and interpretation and image documentation and report; with transluminal balloon angioplasty, peripheral dialysis segment, including all imaging and radiological supervision and interpretation necessary to perform the angioplasty), which has an intraservice time of 40 minutes and a total time of 86 minutes. We believed that CPT code 36902 describes a service that is similar to the new CPT code 50437) and therefore provides a reasonable crosswalk. We proposed a work RVU of 4.83 for CPT code 50437.
We proposed the RUC-recommended work RVU of 3.37 for CPT code 52334 (Cystourethroscopy with insertion of ureteral guide wire through kidney to establish a percutaneous nephrostomy, retrograde) and the RUC-recommended work RVU of 0.83 for CPT code 74485 (Dilation of ureter(s) or urethra, radiological supervision and interpretation).
For the direct PE inputs, we proposed to remove the clinical labor time for the “Confirm availability of prior images/studies” (CA006) activity for CPT code 52334. This code does not currently include this clinical labor time, and unlike the two new codes in the family (CPT codes 50436 and 50437), CPT code 52334 does not include imaging guidance in its code descriptor. When CPT code 52334 is performed with imaging guidance, it would be billed together with a separate imaging code that already includes clinical labor time for confirming the availability of prior images. As a result, we believed that it would be duplicative to include this clinical labor time in CPT code 52334.
The following is a summary of the public comments we received on our proposals involving the Dilation of Urinary Tract family of codes.
In September 2017, the CPT Editorial Panel created a new code (CPT code
For CPT code 53850 (Transurethral destruction of prostate tissue; by microwave thermotherapy), the RUC recommended a work RVU of 5.42, supported by a direct crosswalk to CPT code 33272 (Removal of subcutaneous implantable defibrillator electrode) with a total time of 151 minutes, intraservice time of 45 minutes, and a work RVU of 5.42. The RUC indicated that a work RVU of 5.42 accurately reflects the lowest value of the three CPT codes in this family. We proposed the work RVU of 5.42 for CPT code 53850, as recommended by the RUC.
The RUC recommended a work RVU of 5.93 for CPT code 53852 (Transurethral destruction of prostate tissue; by radiofrequency thermotherapy) and for CPT code 53854 (Transurethral destruction of prostate tissue; by radiofrequency generated water vapor thermotherapy). We proposed the RUC-recommended work RVU of 5.93 for CPT code 53852.
CPT code 53854 is a service reflecting the use of a new technology, “radiofrequency generated water vapor thermotherapy,” as distinct from CPT code 53852, which describes destruction of tissue by “radiofrequency thermotherapy.” The RUC indicated that this CPT code is the most intense of the three CPT codes in this family, thereby justifying a work RVU identical to that of CPT code 53852, despite lower intraservice and total times. The RUC stated that 15 minutes of post service time is appropriate due to greater occurrence of post-procedure hematuria necessitating a longer monitoring time. However, the post-service monitoring time for this CPT code, 15 minutes, is identical to that for CPT code 53852. We did not agree with the explanation provided by the RUC for recommending a work RVU identical to that of CPT code 53852, given that the total time is 5 minutes lower, and the post service times are identical. Both the intraservice time ratio between this new CPT code and CPT code 53852 (4.94) and the total time ratio between the two CPT codes (5.72) suggest that the RUC-recommended work RVU of 5.93 overestimates the work involved in furnishing this service. We reviewed other 90-day global CPT codes with similar times and identified CPT code 24071 (Excision, tumor, soft tissue of upper arm or elbow area, subcutaneous; 3 cm or greater) with a total time of 183 minutes, intraservice time of 45 minutes, and a work RVU of 5.70 as an appropriate crosswalk. We believed that this would be a better reflection of the work involved in furnishing CPT code 53854, and therefore, we proposed a work RVU of 5.70 for this CPT code. We welcomed comments about the time and intensity required to furnish this new service. Since this CPT code reflects the use of a new technology, it will be reviewed again in 3 years.
For the direct PE inputs, we proposed to add a new supply (SA128: “kit, Rezum delivery device”), a new equipment item (EQ389: “generator, water thermotherapy procedure”), and proposed to update the price of two supplies (SA036: “kit, transurethral microwave thermotherapy” and SA037: “kit, transurethral needle ablation (TUNA)”) after reviewing invoices that we received. We noted that these invoices were submitted along with additional information listing the vendor discount for these supplies and equipment. We appreciated the inclusion of the discounted prices on these invoices, and we encouraged other invoice submissions to provide the discounted price as well, where available. Based on market research on supply and equipment pricing carried out by our contractors, we believe that a vendor discount of 10-15 percent is common on many supplies and equipment. Since we are obligated by statute to establish RVUs for each service as required based on the resource inputs required to furnish the typical case of a service, we have concerns that relying on invoices for supply and equipment pricing absent these vendor discounts may overestimate the resource cost of some services. We encouraged the submission of additional invoices that include the discounted price of supplies and equipment to more accurately assess the market cost of these resources.
The following is a summary of the public comments we received on our proposals involving the Transurethral Destruction of Prostate Tissue family of codes.
After consideration of the comments, we are finalizing the RUC-recommended work RVUs and direct PE inputs for the three codes in the Transurethral Destruction of Prostate Tissue family of codes.
CPT codes 57150 (Irrigation of vagina and/or application of medicament for treatment of bacterial, parasitic, or fungoid disease) and 57160 (Fitting and insertion of pessary or other intravaginal support device) were identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. For CY 2019, we proposed the RUC-recommended work RVU of 0.50 for CPT code 57150 and the RUC-recommended work RVU of 0.89 for CPT code 57160.
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on our proposals involving the Vaginal Treatments family of codes.
After consideration of the public comments, we are finalizing the RUC-recommended work RVUs and direct PE inputs for CPT codes 57150 and 57160 as proposed.
CPT code 58100 (Endometrial sampling (biopsy) with or without endocervical sampling (biopsy), without cervical dilation, any method) was identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. CPT code 58110 (Endometrial sampling (biopsy) performed in conjunction with colposcopy) was also included for review as part of the same family of codes. For CY 2019, we proposed the RUC-recommended work RVU of 1.21 for CPT code 58100 and the RUC-recommended work RVU of 0.77 for CPT code 58110.
For the direct PE inputs, we proposed to remove the clinical labor time for the “Review/read post-procedure x-ray, lab and pathology reports” (CA028) activity for CPT code 58100. This code is typically billed with a same day E/M service, and we believe that it would be duplicative to assign clinical labor time for reviewing reports given that this task would typically be done during the same day E/M service. We also proposed to refine the equipment times in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on our proposals involving the Biopsy of Uterus Lining family of codes.
After consideration of the public comments, we are finalizing the work RVUs and the direct PE inputs for the codes in the Biopsy of Uterus Lining family of codes as proposed.
CPT code 64405 (Injection, anesthetic agent; greater occipital nerve) was identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. For CY 2019, we proposed the RUC-recommended work RVU of 0.94 for CPT code 64405.
For the direct PE inputs, we proposed to refine the equipment time for the exam table (EF023) in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on our proposals involving CPT code 64405.
After consideration of the public comments, we are finalizing the work RVU and the direct PE inputs for CPT code 64405 as proposed.
CPT code 64455 (Injection(s), anesthetic agent and/or steroid, plantar common digital nerve(s) (
For the direct PE inputs, we proposed to refine the equipment time for the exam table (EF023) in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on our proposals involving CPT code 64455.
After consideration of the public comments, we are finalizing the work RVU and the direct PE inputs for CPT code 64455 as proposed.
CPT codes 65205 (Removal of foreign body, external eye; conjunctival superficial) and 65210 (Removal of foreign body, external eye; conjunctival embedded (includes concretions), subconjunctival, or scleral nonperforating) were identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000.
For CY 2019, we proposed the RUC-recommended work RVU of 0.49 for CPT code 65205. We noted that the recommendations for this code included a statement that the work required to perform CPT code 65205 and the procedure itself had not fundamentally changed since the time of the last review. However, due to the fact that the surveyed intraservice time had decreased from 5 minutes to 3 minutes, the work RVU was lowered from the current value of 0.71 to the recommended work RVU of 0.49, based on a direct crosswalk to CPT code 68200 (Subconjunctival injection). We noted that this recommendation appears to have been developed under a methodology similar to our ongoing use of time ratios as one of several methods used to evaluate work. We used time ratios to identify potential work RVUs and considered these work RVUs as potential options relative to the values developed through other options. As we have stated in past rulemaking (such as 82 FR 53032-53033), we did not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in newly valued work RVUs, as indeed it does not in the case of CPT code 65205 here. Instead, we believed that, since the two components of work are time and intensity, significant decreases in time should be reflected in decreases to work RVUs. We appreciate that the RUC-recommended work RVU for CPT code 65205 has taken these changes in work time into account, and we support the use of similar methodologies, where appropriate, in future work valuations.
For CPT code 65210, we disagreed with the RUC-recommended work RVU of 0.75 and we proposed a work RVU of 0.61 based on a direct crosswalk to CPT code 92511 (Nasopharyngoscopy with endoscope). This crosswalk code has the same intraservice time of 5 minutes and 4 additional minutes of total time as compared to CPT code 65210. We noted that the recommended intraservice time for CPT code 65210 is decreasing from 13 minutes to 5 minutes (62 percent reduction), and the recommended total time for CPT code 65210 is decreasing from 25 minutes to 13 minutes (48 percent reduction); however, the RUC-recommended work RVU is only decreasing from 0.84 to 0.75, which is a reduction of about 11 percent. As we noted earlier, we do not believe that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, and we did not propose a linear decrease in the work valuation based on these time ratios. However, we believe that since the two components of work are time and intensity, significant decreases in time should be reflected in decreases to work RVUs, and we do not believe that the recommended work RVU of 0.75 appropriately reflects these decreases in surveyed work time.
Our proposed work RVU of 0.61 is also based on a crosswalk to CPT code 51700 (Bladder irrigation, simple, lavage and/or instillation), another recently reviewed code with higher time values and a work RVU of 0.60. We also noted that two injection codes (CPT codes 20551 and 64455) were reviewed at the same RUC meeting as CPT code 65210, each of which shared the same intraservice time of 5 minutes and had a higher total time of 21 minutes. Both of these codes had a RUC-recommended work RVU of 0.75, which we proposed without refinement for CY 2019. Due to the fact that CPT code 65210 has a lower total time and a lower intensity than both of these injection procedures, we did not agree that CPT code 65210 should be valued at the same work RVU of 0.75. We believe that our proposed work RVU of 0.61 based on a crosswalk to CPT code 92511 is a more accurate value for this code.
For the direct PE inputs, we noted that the RUC-recommended equipment time for the screening lane (EL006)
The following is a summary of the public comments we received on our proposals involving the Removal of Foreign Body—Eye family of codes.
After consideration of the public comments, we are finalizing the work RVUs and the direct PE inputs for the codes in the Removal of Foreign Body—Eye family of codes as proposed.
CPT code 67515 (Injection of medication or other substance into Tenon's capsule) was identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. CPT codes 67500 (Retrobulbar injection; medication (separate procedure, does not include supply of medication)) and 67505 (Retrobulbar injection; alcohol) were also included for review as part of the same family of codes. For CY 2019, we proposed the RUC-recommended work RVU of 1.18 for CPT code 67500.
For CPT code 67505, we disagreed with the RUC-recommended work RVU of 1.18 and we proposed a work RVU of 0.94 based on a direct crosswalk to CPT code 31575 (Laryngoscopy, flexible; diagnostic). This is a recently reviewed code with the same intraservice time of 5 minutes and 2 fewer minutes of total time as compared to CPT code 67505. We disagreed with the recommendation to propose the same work RVU of 1.18 for both CPT code 67500 and 67505 for several reasons. We noted that the current work RVU of 1.44 for CPT code 67500 is higher than the current work RVU of 1.27 for CPT code 67505, while the current work time of CPT code 67500 is less than the current work time for CPT code 67505. This supported the view that CPT code 67500 should be valued higher than CPT code 67505 due to its greater intensity, which we also found to be supportable on clinical grounds. The typical patient for CPT code 67505 has already lost their sight, and there is less of a concern about accidental blindness as compared to CPT code 67500. At the recommended identical work RVUs, CPT code 67500 has almost triple the intensity of CPT code 67505. Similarly, the intensity does not match our clinical understanding of the complexity and difficulty of the two procedures.
We also noted that the surveyed total time for CPT code 67505 was 7 minutes less than the surveyed time for CPT code 67500, approximately 21 percent lower. If we were to take the total time ratio between the two codes, it would produce a suggested work RVU of 0.93 (26 minutes divided by 33 minutes times a work RVU of 1.18). This time ratio suggested a work RVU almost identical to the 0.94 value that we determined via a crosswalk to CPT code 31575. Based on the preceding rationale, we proposed a work RVU of 0.94 for CPT code 67505.
For CPT code 67515, we disagreed with the RUC-recommended work RVU of 0.84 and we proposed a work RVU of 0.75 based on a crosswalk to CPT code 64450 (Injection, anesthetic agent; other peripheral nerve or branch). The recommended work RVU is based on a direct crosswalk to CPT code 65222 (Removal of foreign body, external eye; corneal, with slit lamp) at a work RVU of 0.84. However, the recommended crosswalk code has more than double the intraservice time of CPT code 67515 at 7 minutes, and we believe that it would be more accurate to use a crosswalk to a code with a more similar intraservice time such as CPT code 64450, which is another type of injection procedure. The proposed work RVU of 0.75 is also based on the use of the intraservice time ratio with the first code in the family, CPT code 67500. The intraservice time ratio between these codes is 0.60 (3 minutes divided by 5 minutes), which yields a suggested work RVU of 0.71 when multiplied by the recommended work RVU of 1.18 for CPT code 67500. We believe that this provides further rationale for our proposed work RVU of 0.75 for CPT code 67515.
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on our proposals involving the Injection—Eye family of codes.
After consideration of the public comments, we are finalizing the work RVUs for CPT codes 67500 and 67515 as proposed. We are finalizing the RUC-recommended work RVU of 1.18 for CPT code 67505. We are also finalizing the direct PE inputs for all three codes as proposed.
CPT codes 72020 (Radiologic examination, spine, single view, specify level) and 72072 (Radiologic examination, spine; thoracic, 3 views) were identified on a screen of CMS or
The radiologic examination procedures described by CPT codes 72020 (Radiologic examination, spine, single view, specify level), 72040 (Radiologic examination, spine, cervical; 2 or 3 views), 72050 (Radiologic examination, spine, cervical; 4 or 5 views), 72052 (Radiologic examination, spine, cervical; 6 or more views), 72070 (Radiologic examination, spine; thoracic, 2 views), 72072 (Radiologic examination, spine; thoracic, 3 views), 72074 (Radiologic examination, spine; thoracic, minimum of 4 views), 72080 (Radiologic examination, spine; thoracolumbar junction, minimum of 2 views), 72100 (Radiologic examination, spine, lumbosacral; 2 or 3 views), 72110 (Radiologic examination, spine, lumbosacral; minimum of 4 views), 72114 (Radiologic examination, spine, lumbosacral; complete, including bending views, minimum of 6 views), 72120 (Radiologic examination, spine, lumbosacral; bending views only, 2 or 3 views), 72200 (Radiologic examination, sacroiliac joints; less than 3 views), 72202 (Radiologic examination, sacroiliac joints; 3 or more views), 72220 (Radiologic examination, sacrum and coccyx, minimum of 2 views), 73070 (Radiologic examination, elbow; 2 views), 73080 (Radiologic examination, elbow; complete, minimum of 3 views), 73090 (Radiologic examination; forearm, 2 views), 73650 (Radiologic examination; calcaneus, minimum of 2 views), and 73660 (Radiologic examination; toe(s), minimum of 2 views) were all identified as potentially misvalued through a screen for CPT codes with high utilization.
With approval from the RUC Research Subcommittee, the specialty societies responsible for reviewing these CPT codes did not conduct surveys, but instead employed a “crosswalk methodology,” in which they derived physician work and time components for CPT codes by comparing them to similar CPT codes. We recognize that a substantial amount of time and effort is involved in conducting surveys of potentially misvalued CPT codes; however, we had concerns about the quality of the underlying data used to value these CPT codes. The descriptors and other information on which the recommendations are based have themselves not been surveyed, in several instances, since 1995. Without the benefit of a survey or other external source of data about these CPT codes, there is no information that would allow us to detect any potential improvements in efficiency of furnishing the service or evaluate whether changes in practice patterns have affected time and intensity. We are not categorically opposed to changes in the RUC process or methodology that might reduce the burden of conducting surveys, but without the benefit of any additional data, through surveys or otherwise, we were not convinced that there was a basis for evaluating the RUC's recommendations for work RVUs for each of these CPT codes.
Since all 20 of the CPT codes in this group have very similar intraservice (from 3-5 minutes) and total (ranging from 5-8 minutes) times, we proposed to use an alternative approach to the valuation of work RVUs for these CPT codes. We calculated the utilization-weighted average RUC-recommended work RVU for the 20 CPT codes. The result of this calculation was a work RVU of 0.23, which we proposed to apply uniformly to each CPT code: 72020, 72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110, 72114, 72120, 72200, 72202, 72220, 73070, 73080, 73090, 73650, and 73660. We recognized that the proposed work RVU for some of these CPT codes might be somewhat lower at the code level than the RUC's recommendation, while the proposed work RVU for other CPT codes might be slightly higher than the RUC's recommended value. We nevertheless believe that the alternative, accepting the RUC's recommendation for each separate CPT code implied a level of precision about the time and intensity of the CPT codes that we had no way to validate.
For the direct PE inputs, we proposed to add a patient gown (SB026) supply to CPT code 72120. We noted that all of the other codes in the family that included clinical labor time for the “Greet patient, provide gowning, ensure appropriate medical records are available” (CA009) task included a patient gown, and we proposed to add the patient gown to match the other codes in the family. We believed that the exclusion of the patient gown for CPT code 72120 was most likely due to a clerical error in the recommendations. We also proposed to refine the equipment time for the basic radiology room (EL012) in accordance with our standard equipment time formulas.
In our review of the clinical labor time recommended for the “Perform procedure/service—NOT directly related to physician work time” (CA021) task, we noted that the standard convention for this family of codes seemed to be 3 minutes of clinical labor time per view being conducted. For example, CPT code 72020 with a single view had 3 minutes of recommended clinical labor time for this activity, while CPT code 72070 with two views had 6 minutes. However, we also noted that for the codes with 2-3 views such as CPT codes 72040 and 72100, the recommended clinical labor time of 9 minutes appears to assume that 3 views would always be typical for the procedure. The same pattern occurred for codes with 4-5 views, which have a recommended clinical labor time of 15 minutes (assuming 5 views is typical), and for codes with 6 or more views, which have a recommended clinical labor time of 21 minutes (assuming 7 views is typical).
We did not propose to refine the clinical labor times for this task as we did not have data available to know how many views would be typical for these CPT codes. However, we noted that the intraservice clinical labor time has not changed in roughly 2 decades for these X-ray services, including during this most recent review, and we believed that improving technology during this span of time may have resulted in greater efficiencies in the procedures. We continue to be interested in data sources regarding the intraservice clinical labor times for services such as these that do not match the physician intraservice time, and we welcomed any comments that may be able to provide additional details for the 12 codes under review in this family.
The following is a summary of the public comments we received on our proposals involving the X-Ray Spine family of codes.
After consideration of the public comments, we are maintaining the CY 2018 work RVUs for the codes in the X-Ray Spine family of codes. We are finalizing the direct PE inputs for these codes as proposed.
CPT code 72220 (Radiologic examination, sacrum and coccyx, minimum of 2 views) was identified on a screen of CMS or Other source codes with Medicare utilization greater than 100,000 services annually. CPT codes 72200 (Radiologic examination, sacroiliac joints; less than 3 views) and 72202 (Radiologic examination, sacroiliac joints; 3 or more views) were also included for review as part of the same family of codes. See (31) X-Ray Spine (CPT codes 72020, 72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110, 72114, and 72120) for a discussion of proposed work RVUs for these codes.
For the direct PE inputs, we proposed to refine the equipment time for the basic radiology room (EL012) in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on our proposals involving the X-Ray Sacrum family of codes.
After consideration of the public comments, we are maintaining the CY 2018 work RVUs for the codes in the X-Ray Sacrum family of codes. We are finalizing the direct PE inputs for these codes as proposed.
CPT codes 73070 (Radiologic examination, elbow; 2 views) and 73090 (Radiologic examination; forearm, 2 views) were identified on a screen of CMS or Other source codes with Medicare utilization greater than 100,000 services annually. CPT code 73080 (Radiologic examination, elbow; complete, minimum of 3 views) was also included for review as part of the same family of codes. See (31) X-Ray Spine (CPT codes 72020, 72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110, 72114, and 72120) above for a discussion of proposed work RVUs for these codes.
For the direct PE inputs, we proposed to refine the equipment time for the
The following is a summary of the public comments we received on our proposals involving the X-Ray Elbow-Forearm family of codes.
After consideration of the public comments, we are maintaining the CY 2018 work RVUs for the codes in the X-Ray Elbow-Forearm family of codes. We are finalizing the direct PE inputs for these codes as proposed.
CPT code 73650 (Radiologic examination; calcaneus, minimum of 2 views) was identified on a screen of CMS or Other source codes with Medicare utilization greater than 100,000 services annually. See (31) X-Ray Spine above for a discussion of proposed work RVUs for these codes.
For the direct PE inputs, we proposed to refine the equipment time for the basic radiology room (EL012) in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on our proposals involving CPT code 73650.
After consideration of the public comments, we are maintaining the CY 2018 work RVUs for the codes in the X-Ray Heel family of codes. We are finalizing the direct PE inputs for these codes as proposed.
CPT code 73660 (Radiologic examination; toe(s), minimum of 2 views) was identified on a screen of CMS or Other source codes with Medicare utilization greater than 100,000 services annually. See (31) X-Ray Spine above for a discussion of proposed work RVUs for these codes.
For the direct PE inputs, we proposed to add a patient gown (SB026) supply to CPT code 73660. We noted that the other codes in related X-ray code families that included clinical labor time for the “Greet patient, provide gowning, ensure appropriate medical records are available” (CA009) task included a patient gown, and we proposed to add the patient gown to match the other codes in these families. We also proposed to refine the equipment time for the basic radiology room (EL012) in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on our proposals involving CPT code 73660.
After consideration of the public comments, we are maintaining the CY 2018 work RVUs for the codes in the X-Ray Toe family of codes. We are finalizing the direct PE inputs as proposed with the exception of the patient gown (SB026) supply as detailed above.
CPT code 74220 (Radiologic examination; esophagus) was identified on a screen of CMS or Other source codes with Medicare utilization greater than 100,000 services annually. CPT codes 74210 (Radiologic examination; pharynx and/or cervical esophagus) and 74230 (Swallowing function, with cineradiography/videoradiography) were also included for review as part of the same family of codes.
We proposed the work RVUs recommended by the RUC for the CPT codes in this family as follows: A work RVU 0.59 for CPT code 74210 (Radiologic examination; pharynx and/or cervical esophagus), a work RVU of 0.67 for CPT code 74220 (Radiologic examination; esophagus), and a work RVU of 0.53 for CPT code 74230 (Swallowing function, with cineradiography/videoradiography).
For the direct PE inputs, we noted that the recommended quantity of the Polibar barium suspension (SH016) supply is increasing from 1 ml to 150 ml for CPT code 74210 and 100 ml are being added to CPT code 74220, which did not previously include this supply. The RUC recommendation states that this supply quantity increase is due to clinical necessity, but does not go into further details about the typical use of the supply. Although we did not propose to refine the quantity of the Polibar barium suspension at this time, we solicited additional comment about the typical use of the supply in these procedures. We also proposed to refine the equipment times for all three codes in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on our
After consideration of the public comments, we are finalizing the work RVU and the direct PE inputs for the codes in the X-Ray Esophagus family of codes as proposed.
CPT code 74420 (Urography, retrograde, with or without KUB) was identified on a screen of CMS or Other source codes with Medicare utilization greater than 100,000 services annually. We proposed the RUC-recommended work RVU of 0.52 for CPT code 74420 (Urography, retrograde, with or without KUB).
For the direct PE inputs, we proposed to remove the 1 minute of clinical labor time for the “Confirm order, protocol exam” (CA014) activity. The clinical labor time recommended for this activity is not included in the reference code, nor is it included in any of the two dozen other X-ray codes that were reviewed at the same RUC meeting. There is also no explanation in the recommended materials as to why this clinical labor time would need to be added. We do not believe that this clinical labor would be typical for CPT code 74420, and we proposed to remove it to match the rest of the X-ray codes. We also proposed to refine the equipment times in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on our proposals involving CPT code 74420.
After consideration of the public comments, we are finalizing the work RVU and the direct PE inputs for CPT code 74420 as proposed.
CPT code 76000 (Fluoroscopy (separate procedure), up to 1 hour physician or other qualified health care professional time) was identified on a screen of CMS or Other source codes with Medicare utilization greater than 100,000 services annually. CPT code 76001 (Fluoroscopy, physician or other qualified health care professional time more than 1 hour, assisting a nonradiologic physician or other qualified health care professional) was also included for review as part of the same family of codes. However, due to the fact that supervision and interpretation services have been increasingly bundled into the underlying procedure codes, the RUC concluded that this practice is rare, if not obsolete, and CPT code 76001 was recommended for deletion by the CPT Editorial Panel for CY 2019.
We proposed the RUC-recommended work RVU of 0.30 for CPT code 76000 (Fluoroscopy (separate procedure), up to 1 hour physician or other qualified health care professional time, other than 71023 or 71034 (
We did not receive specific comments regarding our proposals for CPT code 76000. We are finalizing a work RVU of 0.30 and the direct PE inputs for CPT code 76000 as proposed.
CPT code 76514 (Ophthalmic ultrasound, diagnostic; corneal pachymetry, unilateral or bilateral (determination of corneal thickness)) was identified as potentially misvalued on a screen of codes with a negative intraservice work per unit of time (IWPUT), with 2016 estimated Medicare utilization over 10,000 for RUC reviewed codes and over 1,000 for Harvard-valued and CMS/Other source codes.
For CPT code 76514, we disagreed with the RUC-recommended work RVU of 0.17 and we proposed a work RVU of 0.14. We noted that the recommended intraservice time for CPT code 76514 is decreasing from 5 minutes to 3 minutes (40 percent reduction), and the recommended total time for CPT code 76514 is decreasing from 15 minutes to 5 minutes (67 percent reduction); however, the RUC-recommended work RVU is not decreasing at all and remains at 0.17. Although we did not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should be reflected in decreases to work RVUs.
We also noted that the RUC recommendations for CPT code 76514 stated that, although the steps in the procedure are unchanged since it was first valued, the workflow has changed. With the advent of smaller and easier to use pachymeters, the technician now typically takes the measurements that used to be taken by the practitioner for CPT code 76514, and the intraservice time was reduced by two minutes to account for the technician performing this service. We believe that this change in workflow indicates that the work RVU for the code should be reduced in some fashion, since some of the work
Therefore, we proposed a work RVU of 0.14 for CPT code 76514, which is based on taking half of the intraservice time ratio. We considered applying the intraservice time ratio to CPT code 76514, which would reduce the work RVU to 0.10 based on taking the change in intraservice time (from 5 minutes to 3 minutes) and multiplying this ratio of 0.60 times the current work RVU of 0.17. However, we recognized that the minutes shifted to the clinical staff were less intense than the minutes that remained in CPT code 76514, and therefore, we applied half of the intraservice time ratio for a reduction of 0.03 RVUs to arrive at a proposed work RVU of 0.14. We believe that this proposed value more accurately takes into account the changes in workflow that have caused substantial reductions in the surveyed work time for the procedure.
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on our proposals involving CPT code 76514.
After consideration of the public comments, we are finalizing the work RVU and the direct PE inputs for CPT code 76514 as proposed.
In September 2017, the CPT Editorial Panel created three new codes describing the use of ultrasound elastography to assess organ parenchyma and focal lesions: CPT codes 76981 (Ultrasound, elastography; parenchyma), 76982 (Ultrasound, elastography; first target lesion) and 76983 (Ultrasound, elastography; each additional target lesion). The most common use of this code set will be for preparing patients with disease of solid organs, like the liver, or lesions within solid organs.
The RUC recommended a work RVU of 0.59 for CPT code 76981 (Ultrasound, elastography; parenchyma (
For the direct PE inputs, we proposed to refine the clinical labor time for the “Prepare room, equipment and supplies” (CA013) activity to 3 minutes and to refine the clinical labor time for the “Confirm order, protocol exam” (CA014) activity to 0 minutes for CPT codes 76981 and 76982. CPT code 76700 (Ultrasound, abdominal, real time with image documentation; complete), the reference code for these two new codes, did not previously have clinical labor time assigned for the “Confirm order, protocol exam” clinical labor task, and we do not have any reason to believe that these particular services being furnished by the clinical staff have changed in the new codes, only the way in which this clinical labor time has been presented on the PE
The following is a summary of the public comments we received on our proposals involving the Ultrasound Elastography family of codes.
After consideration of the public comments, we are finalizing the work RVUs for the codes in the Ultrasound Elastography family of codes as proposed: 0.59 work RVUs for CPT code 76981, 0.59 work RVUs for CPT code 76982, and 0.50 work RVUs for CPT code 76983. We are not finalizing our proposed direct PE inputs and are instead finalizing the RUC-recommended direct PE inputs for these three codes.
CPT code 76870 (Ultrasound, scrotum and contents) was identified on a screen of CMS or Other source codes with Medicare utilization greater than 100,000 services annually. We proposed a work RVU of 0.64 for CPT code 76870 (Ultrasound, scrotum and contents), as recommended by the RUC.
For the direct PE inputs, we proposed to refine the clinical labor time for the “Prepare room, equipment and supplies” (CA013) activity to 3 minutes and to refine the clinical labor time for the “Confirm order, protocol exam” (CA014) activity to 0 minutes. CPT code 76870 did not previously have clinical labor time assigned for the “Confirm order, protocol exam” clinical labor task, and we did not have any reason to believe that the services being furnished by the clinical staff have changed, only the way in which this clinical labor time has been presented on the PE worksheets. We also noted that there was no effect on the total clinical labor direct costs in these situations since the same 3 minutes of clinical labor time is still being furnished under the CA013 room preparation activity. We also proposed to refine the equipment times in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on our proposals involving CPT code 76870.
After consideration of the public comments, we are finalizing the work RVU of 0.64 and direct PE inputs for CPT code 76870 as proposed.
In September 2017, the CPT Editorial Panel created two new CPT codes describing the use of intravenous microbubble agents to evaluate suspicious lesions by ultrasound. CPT code 76978 (Ultrasound, targeted dynamic microbubble sonographic contrast characterization (non-cardiac); initial lesion) is a stand-alone procedure for the evaluation of a single target lesion. CPT code 76979 (Ultrasound, targeted dynamic microbubble sonographic contrast characterization (non-cardiac); each additional lesion with separate injection) is an add-on code for the evaluation of each additional lesion.
The two new CPT codes in this family represent a new technology that involves the use of intravenous microbubble agents to evaluate suspicious lesions by ultrasound. The first new CPT code 76978 (Ultrasound, targeted dynamic microbubble sonographic contrast characterization (non-cardiac); initial lesion), is the base code for the new add-on CPT code 76979 (Ultrasound, targeted dynamic microbubble sonographic contrast characterization (non-cardiac); each additional lesion with separate injection). The RUC reviewed the survey results for CPT code 76978 and recommended total time of 30 minutes and intraservice time of 20 minutes. Their recommendation for a work RVU of 1.62 is based neither on the median of the survey results (1.82) nor the 25th percentile of the survey results (1.27). Instead, the RUC-recommended work RVU is based on a crosswalk to CPT code 73719 (Magnetic resonance (
Although we generally agree that, particularly in instances where a CPT code represents a new technology or procedure, there may be reason to deviate from survey metrics, we are confused by the logic behind the RUC's recommendation of a work RVU of 1.62 for CPT code 76978. When we considered the range of existing CPT codes with 30 minutes total time and 20 minutes intraservice time, we noted that a work RVU of 1.62 is among the highest potential crosswalks. We also noted that the RUC agreed with the 25th percentile of survey results for the new add-on CPT code, 76979, and we did not see
For the direct PE inputs, we proposed to refine the clinical labor time for the “Prepare room, equipment and supplies” (CA013) activity to 3 minutes and to refine the clinical labor time for the “Confirm order, protocol exam” (CA014) activity to 0 minutes for CPT code 76978. CPT codes 76700 (Ultrasound, abdominal, real time with image documentation; complete) and 76705 (Ultrasound, abdominal, real time with image documentation; limited), the reference codes for this new code, did not previously have clinical labor time assigned for the “Confirm order, protocol exam” clinical labor task, and we did not have any reason to believe that these particular services being furnished by the clinical staff have changed in the new code, only the way in which this clinical labor time has been presented on the PE worksheets. We also noted that there is no effect on the total clinical labor direct costs in these situations, since the same 3 minutes of clinical labor time is still being furnished in CPT code 76978.
We proposed to remove the 50 ml of the phosphate buffered saline (SL180) for CPT codes 76978 and 76979. When these codes were reviewed by the RUC, the conclusion that was reached was to remove this supply and replace it with normal saline. Since the phosphate buffered saline remained in the recommended direct PE inputs, we believe its inclusion may have been a clerical error. We proposed to remove the supply and solicited comments on the phosphate buffered saline or a replacement saline solution. We also proposed to refine the equipment times in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on our proposals involving the Contrast-Enhanced Ultrasound family of codes.
We were, however, persuaded by commenters that the higher technical skill and time involved in using the new technology, CEUS, compared with other established ultrasound services, is better reflected by the RUC's recommended work RVU than our proposed value. Consequently we are finalizing the RUC-recommended work RVU of 1.62 for CPT code 76978.
After consideration of the public comments, we are finalizing the RUC-recommended work RVUs for both codes in this family as follows: Work RVU of 0.85 for CPT code 76979 and a work RVU of 1.62 for CPT code 76978. We are also finalizing the RUC-recommended direct PE inputs for these codes, with the exception of the refinement to the phosphate buffered saline (SL180) supply as detailed above.
The CPT Editorial Panel created new stand-alone CPT code 76391 describing the use of magnetic resonance elastography for the evaluation of organ parenchymal pathology. This code will most often be used to evaluate patients
The RUC recommended a work RVU for new CPT code 76391 (Magnetic resonance (
For the direct PE inputs, we proposed to refine the clinical labor time for the “Prepare room, equipment and supplies” (CA013) activity from 6 minutes to 5 minutes, and for the “Prepare, set-up and start IV, initial positioning and monitoring of patient” (CA016) activity from 4 minutes to 3 minutes. We disagreed that this additional clinical labor time would be typical for these activities, which are already above the standard times for these tasks. In both cases, we proposed to maintain the current time from the reference CPT code 72195 (Magnetic resonance (
The following is a summary of the public comments we received on our proposals involving CPT code 76391.
After consideration of the public comments, we are finalizing the work RVU of 1.10 and the direct PE inputs for CPT code 76391 as proposed.
CPT code 77012 (Computed tomography guidance for needle placement (
We proposed the RUC-recommended work RVU of 1.50 for CPT code 77012 (Computed tomography guidance for needle placement (
For the direct PE inputs, we proposed to refine the clinical labor time for the “Prepare room, equipment and supplies” (CA013) activity to 3 minutes and to refine the clinical labor time for the “Confirm order, protocol exam” (CA014) activity to 0 minutes. CPT code 77012 did not previously have clinical labor time assigned for the “Confirm order, protocol exam” clinical labor task, and we did not have any reason to believe that the services being furnished by the clinical staff have changed, only the way in which this clinical labor time has been presented on the PE worksheets. We also noted that there is no effect on the total clinical labor direct costs in these situations since the same 3 minutes of clinical labor time is still being furnished under the CA013 room preparation activity.
We proposed to refine the equipment time for the CT room (EL007) to maintain the current time of 9 minutes. CPT code 77012 is a radiological supervision and interpretation
The following is a summary of the public comments we received on our proposals involving CPT code 77012.
After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for CPT code 77012 as proposed.
CPT code 77081 (Dual-energy X-ray absorptiometry (DXA), bone density study, 1 or more sites; appendicular skeleton (peripheral) (
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on our proposals involving CPT code 77081.
After consideration of the public comments, we are finalizing the work RVU of 0.20 and direct PE inputs for CPT code 77081 as proposed.
CPT codes 77058 (Magnetic resonance imaging, breast, without and/or with contrast material(s); unilateral) and 77059 (Magnetic resonance imaging, breast, without and/or with contrast material(s); bilateral) were identified in 2016 on a high expenditure services screen across specialties with Medicare allowed charges of $10 million or more. When preparing to survey these codes, the specialties noted that the clinical indications had changed for these exams. The technology had advanced to make computer-aided detection (CAD) typical and these codes did not parallel the structure of other magnetic resonance imaging (MRI) codes. In June 2017 the CPT Editorial Panel deleted CPT codes 0159T, 77058, and 77059 and created four new CPT codes to report breast MRI with and without contrast (including computer-aided detection).
The RUC recommended a work RVU of 1.45 for CPT code 77046 (Magnetic resonance imaging, breast, without contrast material; unilateral). This recommendation was based on a comparison with CPT codes 74176 (Computed tomography, abdomen and pelvis; without contrast material) and 74177 (Computed tomography, abdomen and pelvis; with contrast material(s)), which both have similar intraservice and total times in relation to CPT code 77046. We disagreed with the RUC's recommended work RVU because we did not believe that the reduction in total time of 15 minutes between the new CPT code 77046 and the deleted CPT code 77058 was adequately reflected in its recommendation. Although total time has decreased by 15 minutes, the only other difference between the two CPT codes is the change in the descriptor from the phrase `without and/or with contrast material(s)' to `without contrast material,' suggesting that there is less work involved in the new CPT code than in the deleted CPT code. Instead, we proposed a work RVU of 1.15 for CPT code 77046, which is similar to the total time ratio between the new CPT code and the deleted CPT code. It is also supported by a crosswalk to CPT code 77334 (Treatment devices, design and construction; complex (irregular blocks, special shields, compensators, wedges, molds or casts)). CPT code 77334 has total time of 35 minutes, intraservice time of 30 minutes, and a work RVU of 1.15.
CPT code 77047 (Magnetic resonance imaging, breast, without contrast material; bilateral) describes the same work as CPT code 77046, but reflects a bilateral rather than the unilateral procedure. The RUC recommended a work RVU of 1.60 for CPT code 77047. Since we proposed a different work RVU for the unilateral procedure than the value proposed by the RUC, we believe it is appropriate to recalibrate the work RVU for CPT code 77047 relative to the RUC's recommended difference in work between the two CPT codes. The RUC's recommendation for
The RUC recommended a work RVU of 2.10 for CPT code 77048 (Magnetic resonance imaging, breast, without and with contrast material(s), including computer-aided detection (CAD-real time lesion detection, characterization and pharmacokinetic analysis) when performed; unilateral). CPT code 77048 is a new CPT code that bundles the deleted CPT code for unilateral breast MRI without and/or with contrast material(s) with CAD, which was previously reported, in addition to the primary procedure CPT code, as CPT code 0159T (computer aided detection, including computer algorithm analysis of MRI image data for lesion detection/characterization, pharmacokinetic analysis, with further physician review for interpretation, breast MRI). Consistent with our belief that the proposed value for the base CPT code in this series of new CPT codes (CPT code 77046) should be a work RVU of 1.15, we are proposing a work RVU for CPT code 77048 that adds the RUC-recommended difference in RUC-recommended work RVUs between CPT codes 77046 and 77048 (0.65 work RVUs) to the proposed work RVU for CPT code 77046. Therefore, we proposed a work RVU of 1.80 for CPT code 77048.
The last new CPT code in this series, CPT code 77049 (Magnetic resonance imaging, breast, without and with contrast material(s), including computer-aided detection (CAD-real time lesion detection, characterization and pharmoacokinetic analysis) when performed; bilateral) describes the same work as CPT code 77048, but reflects a bilateral rather than a unilateral procedure. The RUC recommended a work RVU of 2.30 for this CPT code. Similar to the process for valuing work RVUs for CPT code 77047 and CPT code 77048, we believe that a more appropriate work RVU is calculated by adding the difference in the RUC recommended work RVU for CPT codes 77046 and 77049, to the proposed value for CPT code 77046. Therefore, we proposed a work RVU of 2.00 for CPT code 77049.
For the direct PE inputs, we proposed to refine the clinical labor time for the “Prepare, set-up and start IV, initial positioning and monitoring of patient” (CA016) activity from 7 minutes to 3 minutes for CPT codes 77046 and 77047, and from 9 minutes to 5 minutes for CPT codes 77048 and 77049. We noted that when the MRI of Lower Extremity codes were reviewed during the previous rule cycle (CPT codes 73718-73720), these codes contained either 3 minutes or 5 minutes of recommended time for this same clinical labor activity. We also noted that the current Breast MRI codes that are being deleted and replaced with these four new codes, CPT codes 77058 and 77059, contain 5 minutes of clinical labor time for this same activity. We had no reason to believe that the new codes would require additional clinical labor time for patient positioning, especially given that the recommended clinical labor times are decreasing in comparison to the reference codes for obtaining patient consent (CA011) and preparing the room (CA013). Therefore, we refined the clinical labor time for the CA016 activity as detailed earlier to maintain relativity with the current clinical labor times in the reference codes, as well as with other recently reviewed MRI procedures.
Included in the recommendations for this code family were five new equipment items: CAD Server (ED057), CAD Software (ED058), CAD Software—Additional User License (ED059), Breast coil (EQ388), and CAD Workstation (CPU + Color Monitor) (ED056). We did not receive any invoices for these five equipment items, and as such we do not have any direct pricing information to use in their valuation. We proposed to use crosswalks to similar equipment items as proxies for three of these new types of equipment until we do have pricing information:
• CAD software (ED058) is crosswalked to flow cytometry analytics software (EQ380).
• Breast coil (EQ388) is crosswalked to Breast biopsy device (coil) (EQ371).
• CAD Workstation (CPU + Color Monitor) (ED056) is crosswalked to Professional PACS workstation (ED053).
We welcomed the submission of invoices with pricing information for these three new equipment items for our consideration to replace the use of these proxies. For the other two equipment items (CAD Server (ED057) and CAD Software—Additional User License (ED059)), we did not propose to establish a price at this time as we believe both of them would constitute forms of indirect PE under our methodology. We do not believe that the CAD Server or Additional User License would be allocated to the use of an individual patient for an individual service, and can be better understood as forms of indirect costs similar to office rent or administrative expenses. We understand that as the PE data age, these issues involving the use of software and other forms of digital tools become more complex. However, the use of new technology does not change the statutory requirement under which indirect PE is assigned on the basis of direct costs that must be individually allocable to a particular patient for a particular service. We look forward to continuing to seek out new data sources to help in updating the PE methodology.
We also proposed to refine the equipment times in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on our proposals involving the Breast MRI with Computer-Aided Detection (CAD) family of codes.
After consideration of the public comments, we are finalizing the RUC-recommended work RVUs for the codes in the Breast MRI with Computer-Aided Detection family of codes. We are finalizing the direct PE inputs as proposed, with the updates to the pricing of the new equipment as detailed above.
CPT code 85060 (Blood smear, peripheral, interpretation by physician with written report) was identified on a screen of CMS or Other source codes with Medicare utilization greater than 100,000 services annually. For CY 2019, the RUC recommended a work RVU of 0.45 based on maintaining the current work RVU.
We disagreed with the recommended value and proposed a work RVU of 0.36 for CPT code 85060 based on the total time ratio between the current time of 15 minutes and the recommended time established by the survey of 12 minutes. This ratio equals 80 percent, and 80 percent of the current work RVU of 0.45 equals a work RVU of 0.36. When we reviewed CPT code 85060, we found that the recommended work RVU was higher than nearly all of the other global XXX codes with similar time values, and we do not believe that this blood smear interpretation procedure would have an anomalously high intensity. Although we did not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should be reflected in decreases to work RVUs. In the case of CPT code 85060, we believe that it would be more accurate to propose the total time ratio at a work RVU of 0.36 to account for these decreases in the surveyed work time.
The proposed work RVU was also based on the use of three crosswalk codes. We directly supported the proposed valuation through a crosswalk to CPT code 95930 (Visual evoked potential (VEP) checkerboard or flash testing, central nervous system except glaucoma, with interpretation and report), which has a work RVU of 0.35 along with 10 minutes of intraservice time and 14 minutes of total time. We also explained the proposed valuation by bracketing it between two other crosswalks, with CPT code 99152 (Moderate sedation services provided by the same physician or other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports; initial 15 minutes of intraservice time, patient age 5 years or older) on the lower end at a work RVU of 0.25 and CPT code 93923 (Complete bilateral noninvasive physiologic studies of upper or lower extremity arteries, 3 or more levels, or single level study with provocative functional maneuvers) on the higher end at a work RVU of 0.45.
The RUC recommended no direct PE inputs for CPT code 85060 and we proposed none.
The following is a summary of the public comments we received on our proposals involving CPT code 85060.
After consideration of the public comments, we are not finalizing our proposed work RVU of 0.36 for CPT code 85060. We are finalizing the RUC-recommended work RVU of 0.45 instead.
CPT code 85097 (Bone marrow, smear interpretation) was identified on a screen of CMS or Other source codes with Medicare utilization greater than 100,000 services annually. For CY 2019, the RUC recommended a work RVU of 1.00 based on a direct crosswalk to CPT code 88121 (Cytopathology, in situ hybridization (
We disagreed with the RUC-recommended value and we proposed a work RVU of 0.94 for CPT code 85097 based on maintaining the current work valuation. We noted that the survey indicated that CPT code 85097 typically takes 25 minutes of work time to perform, down from a previous work time of 30 minutes, and, generally speaking, since the two components of work are time and intensity, we believe that significant decreases in time should be reflected in decreases to work RVUs. For the specific case of CPT code 85097, we supported our proposed work RVU of 0.94 through a crosswalk to CPT code 88361 (Morphometric analysis, tumor immunohistochemistry (
We also considered a work RVU of 0.90 based on double the recommended work RVU of 0.45 for CPT code 85060 (Blood smear, peripheral, interpretation by physician with written report). When both of these CPT codes were under review, the explanation was offered that in a peripheral blood smear, typically, the practitioner does not have the approximately 12 precursor cells to review, whereas in an aspirate from the bone marrow, the practitioner is examining all the precursor cells. Additionally, for CPT code 85097, there are more cell types to look at as well as more slides, usually four, whereas with CPT code 85060 the practitioner would typically only look at one slide. Although we did not propose to value CPT code 85097 at twice the work RVU of CPT code 85060, we believe this analysis also supports maintaining the current work RVU of 0.94 as opposed to raising it to 1.00.
For the direct PE inputs, we proposed to remove the clinical labor time for the “Accession and enter information” (PA001) and “File specimen, supplies, and other materials” (PA008) activities. As we stated previously, information entry and specimen filing tasks are not individually allocable to a particular patient for a particular service and are considered to be forms of indirect PE. Although we agree that these are necessary tasks, under our established methodology we believe that they are more appropriately classified as indirect PE.
The following is a summary of the public comments we received on our proposals involving CPT code 85097.
After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for CPT code 85097 as proposed.
CPT code 85390 (Fibrinolysins or coagulopathy screen, interpretation and report) was identified as potentially misvalued on a screen of codes with a negative IWPUT, with 2016 estimated Medicare utilization over 10,000 for
The following is a summary of the public comments we received on our proposals involving CPT code 85390.
After consideration of the public comments, we are finalizing our proposal to accept the RUC-recommended work RVU for this code.
CPT code 92275 (Electroretinography with interpretation and report) was identified in 2016 on a high expenditure services screen across specialties with Medicare allowed charges of $10 million or more. In January 2016, the specialty society noted that they became aware of inappropriate use of CPT code 92275 for a less intensive version of this test for diagnosis and indications that are not clinically proven and for which less expensive and less intensive tests already exist. CPT changes were necessary to ensure that the service for which CPT code 92275 was intended was clearly described, as well as an accurate vignette and work descriptor were developed. In September 2017, the CPT Editorial Panel deleted CPT code 92275 and replaced it with two new codes to describe electroretinography full field and multi focal. A category III code was retained for pattern electroretinography.
For CPT code 92273 (Electroretinography (ERG) with interpretation and report; full field (
For CPT code 92274 (Electroretinography (ERG) with interpretation and report; multifocal (mfERG)), we disagreed with the RUC-recommended work RVU of 0.72 and proposed a work RVU of 0.61. We concurred that the relative difference in work between CPT code 92273 and 92274 is equivalent to the recommended interval of 0.08 RVUs. Therefore, we proposed a work RVU of 0.61 for CPT code 92274, based on the recommended interval of 0.08 fewer RVUs below our proposed work RVU of 0.69 for CPT code 92273. The proposed work RVU is also based on the use of two crosswalk codes: CPT code 88387 (Macroscopic examination, dissection, and preparation of tissue for non-microscopic analytical studies; each tissue preparation); and CPT code 92100 (Serial tonometry (separate procedure) with multiple measurements of intraocular pressure over an extended time period with interpretation and report, same day). Both codes share the same 20 minutes of intraservice and 20 minutes of total time, with a work RVU of 0.62 for CPT code 88387 and a work RVU of 0.61 for CPT code 92100.
The recommendations for this code family also include CPT Category III code 0509T (Electroretinography (ERG) with interpretation and report, pattern (PERG)). We typically assign contractor pricing for Category III codes since they are temporary codes assigned to emerging technology and services. However, in cases where there is an unusually high volume of services that will be performed under a Category III code, we have sometimes assigned an active status to the procedure and developed RVUs before a formal CPT code is created. In the case of CPT code 0509T, the recommendations indicate that approximately 80 percent of the services currently reported under CPT code 92275 will be reported under the new Category III code. Since this will involve an estimated 100,000 services for CY 2019, we believe that the interests of relativity would be better served by assigning an active status to CPT code 0509T and creating RVUs through the use of a proxy crosswalk to a similar existing service. Therefore, we proposed to assign an active status to CPT Category III code 0509T for CY 2019, with a work RVU and work time values crosswalked from CPT code 92250 (Fundus photography with interpretation and report). CPT code 92250 is a clinically similar procedure that was recently reviewed during the CY 2017 rule cycle. We proposed a work RVU of 0.40 and work times of 10 minutes of intraservice and 12 minutes of total time for CPT code 0509T based on this crosswalk to CPT code 92250.
For the direct PE inputs, we proposed to remove the preservice clinical labor in the facility setting for CPT codes 92273 and 92274. Both of these codes are diagnostic tests under which the professional (26 modifier) and technical (TC modifier) components will be separately billable, and codes that have these professional and technical components typically will not have direct PE inputs in the facility setting since the technical component is only valued in the nonfacility setting. We also noted on this subject that the predecessor code, CPT code 92275, does not currently include any preservice clinical labor, nor any facility direct PE inputs.
We proposed to remove the clinical labor time for the “Greet patient, provide gowning, ensure appropriate medical records are available” (CA009) and the “Provide education/obtain consent” (CA011) activities for CPT codes 92273 and 92274. Both of these CPT codes will typically be reported with a same day E/M service, and we believe that these clinical labor tasks will be carried out during the E/M service. We believe that their inclusion in CPT codes 92273 and 92274 would be duplicative. We also proposed to refine the clinical labor time for the
We proposed to refine the clinical labor time for the “Clean room/equipment by clinical staff” (CA024) activity from 12 minutes to 8 minutes for CPT codes 92273 and 92274. The recommendations for these codes stated that cleaning is carried out in several steps: The patient is first cleaned for 2 minutes, followed by wires and electrodes being scrubbed carefully with detergent, soaked, and then rinsed with sterile water. We agree with the need for 2 minutes of patient cleaning time and for the cleaning of the wires and electrodes to take place in two different steps. However, our standard clinical labor time for room/equipment cleaning is 3 minutes, and therefore, we proposed a total time of 8 minutes for these codes, based on 2 minutes for patient cleaning and then 3 minutes for each of the two steps of wire and electrode cleaning.
We proposed to refine the clinical labor time for the “Technologist QC's images in PACS, checking for all images, reformats, and dose page” (CA030) activity from 10 minutes to 3 minutes for CPT codes 92273 and 92274. We finalized in the CY 2017 PFS final rule (81 FR 80184-80186) a range of appropriate standard minutes for this clinical labor activity, ranging from 2 minutes for simple services up to 5 minutes for highly complex services. We believe that the complexity of the imaging in CPT codes 92273 and 92274 is comparable to the CT and magnetic resonance (MR) codes that have been recently reviewed, such as CPT code 76391 (Magnetic resonance (
We noted that the new equipment item “Contact lens electrode for mfERG and ffERG” (EQ391) was listed twice for CPT code 92273 but only a single time for CPT code 92274. We solicited additional information about whether the recommendations intended this equipment item to be listed twice, with one contact intended for each eye, or whether this was a clerical mistake. We are also interested in additional information as to why the contact lens electrode was listed twice for CPT code 92273 but only a single time for CPT code 92274. Finally, we also proposed to refine the equipment times in accordance with our standard equipment time formulas.
We proposed to use the direct PE inputs for CPT code 92274, including the refinements detailed above, as a proxy for CPT Category III code 0509T until it can be separately reviewed by the RUC.
The following is a summary of the public comments we received on our proposals involving the Electroretinography family of codes.
After consideration of the public comments, we are finalizing the work RVUs for the codes in the Electroretinography family of codes as proposed. We are also finalizing the direct PE inputs as proposed, with the exception of the CA011 clinical labor activity as described above.
CPT codes 93561 (Indicator dilution studies such as dye or thermodilution, including arterial and/or venous catheterization; with cardiac output measurement) and 93562 (Indicator dilution studies such as dye or thermodilution, including arterial and/or venous catheterization; subsequent measurement of cardiac output) were identified as potentially misvalued on a screen of codes with a negative IWPUT, with 2016 estimated Medicare utilization over 10,000 for RUC reviewed codes and over 1,000 for Harvard valued and CMS/Other source codes. The specialty societies noted that CPT codes 93561 and 93562 are primarily performed in the pediatric population, thus the Medicare utilization for these Harvard-source services is not over 1,000. However, the specialty societies requested and the RUC agreed that these services should be reviewed under this negative IWPUT screen.
For CPT code 93561, we disagreed with the RUC-recommended work RVU of 0.95 and we proposed a work RVU of 0.60 based on a crosswalk to CPT code 77003 (Fluoroscopic guidance and localization of needle or catheter tip for spine or paraspinous diagnostic or therapeutic injection procedures (epidural or subarachnoid)). CPT Code 77003 is another recently-reviewed add-on global code with the same 15 minutes of intraservice time and 2 additional minutes of preservice evaluation time. In our review of CPT code 93561, we found that there was a particularly unusual relationship between the surveyed work times and the RUC-recommended work RVU. We noted that the recommended intraservice time for CPT code 93561 was decreasing from 29 minutes to 15 minutes (48 percent reduction), and the recommended total time for CPT code 93561 was decreasing from 78 minutes to 15 minutes (81 percent reduction); however, the recommended work RVU was instead increasing from 0.25 to 0.95, which is an increase of nearly 300 percent. Although we did not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should typically be reflected in decreases to work RVUs, not increases in valuation. We recognized that CPT code 93561 is an unusual case, as it is shifting from 0-day global status to add-on code status. However, when the work time for a code is going down and the unit of service is being reduced, we would not expect to see an increased work RVU under these circumstances, and especially not such a large work RVU increase. Therefore, we proposed instead to crosswalk CPT code 93561 to CPT code 77003 at a work RVU of 0.60, which we believe is a more accurate valuation in relation to other recently-reviewed add-on codes on the PFS. We believe that this proposed work RVU of 0.60 better preserves relativity with other clinically similar codes with similar surveyed work times.
For CPT code 93562, we disagreed with the recommended work RVU of 0.77 and proposed a work RVU of 0.48 based on the intraservice time ratio with CPT code 93561. We observed a similar pattern taking place with CPT code 93562 as with the first code in the family, noting that the recommended intraservice time was decreasing from 16 minutes to 12 minutes (25 percent reduction), and the recommended total time was decreasing from 44 minutes to
There are no recommended direct PE inputs for the codes in this family and we did not propose any direct PE inputs.
The following is a summary of the public comments we received on our proposals involving the Cardiac Output Measurement family of codes.
Many commenters disagreed with the proposed work RVU of 0.60 for CPT code 93561 and stated that CMS should finalize the RUC-recommended work RVU of 0.95. Commenters disagreed with the CMS crosswalk to CPT code 77003, stating that it was not a good crosswalk despite having the same intraservice work time. Commenters stated that CPT code 77003 is the imaging guidance code for needle placement for the epidural injection, and that placing a catheter in the heart and lungs of a child is not merely an imaging procedure. Commenters stated that a more appropriate injection procedure comparison would be the actual epidural injection procedure code, CPT code 62320 (Injection(s), of diagnostic or therapeutic substance(s) (
Many commenters also disagreed with the proposed work RVU of 0.48 for CPT code 93562 and stated that CMS should finalize the RUC-recommended work RVU of 0.77. Commenters stated that using an incremental approach in lieu of strong crosswalks and input from the RUC and physicians providing these services was an unfounded methodology. Commenters stated that CMS should rely on the survey data instead of the use of an increment, and commenters listed the reference codes chosen by the RUC which they stated were more appropriate for valuation.
After consideration of the public comments, we are finalizing the RUC-recommended work RVU of 0.95 for CPT code 93561 and the RUC-recommended work RVU of 0.77 for CPT code 93562. We are also finalizing our proposal to have no direct PE inputs for these codes.
CPT code 93571 (Intravascular Doppler velocity and/or pressure derived coronary flow reserve measurement (coronary vessel or graft) during coronary angiography including pharmacologically induced stress; initial vessel) was identified on a list of all services with total Medicare utilization of 10,000 or more that have increased by at least 100 percent from 2009 through 2014. CPT code 93572 (Intravascular Doppler velocity and/or pressure derived coronary flow reserve measurement (coronary vessel or graft) during coronary angiography including pharmacologically induced stress; each additional vessel) was also included for review as part of the same family of CPT codes. The RUC recommended a work RVU of 1.50 for CPT code 93571, which is lower than the current work RVU of 1.80. The total time for this service decreased by 5 minutes from 20 minutes to 15 minutes. The RUC's recommendation is based on a crosswalk to CPT code 15136 (Dermal autograft, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits; each additional 100 sq cm, or each additional 1% of body area of infants and children, or part thereof), which has an identical intraservice and total time as CPT code 93571 of 15 minutes.
We disagreed with the recommended work RVU of 1.50 for this CPT code because we did not believe that a reduction in work RVU from 1.80 to 1.50 was commensurate with the reduction in time for this service of 5 minutes. Using the building block methodology, we believed the work RVU for CPT code 93571 should be 1.35. We believe that a crosswalk to CPT code 61517 (Implantation of brain intracavitary chemotherapy agent (List separately in addition to CPT code for primary procedure)) with a work RVU of 1.38 was more appropriate because it has an identical intraservice and total time (15 minutes) as CPT code 93571, described work that is similar, and was closer to the calculations for intraservice time ratio, total time ratio, and the building block method. Therefore, we proposed a work RVU of 1.38 for CPT code 93571.
We proposed the RUC-recommended work RVU for CPT code 93572 (Intravascular Doppler velocity and/or pressure derived coronary flow reserve measurement (coronary vessel or graft)
Both of these codes are facility-only procedures with no recommended direct PE inputs.
The following is a summary of the public comments we received on our proposals involving the Coronary Flow Reserve Measurement family of codes.
After consideration of the public comments, we are finalizing the work RVUs for the codes in the Coronary Flow Reserve Measurement family of codes as proposed.
During 2017, we issued a national coverage determination (NCD) for Medicare coverage of supervised exercise therapy (SET) for the treatment of peripheral artery disease (PAD). Previously, the service had been assigned noncovered status under the PFS. CPT code 93668 (Peripheral arterial disease (PAD) rehabilitation, per session) was payable before the end of CY 2017, retroactive to the effective date of the NCD (May 25, 2017), and for CY 2018, CMS made payment for Medicare-covered SET for the treatment of PAD, consistent with the NCD, reported with CPT code 93668. We used the most recent RUC-recommended work and direct PE inputs and requested that the RUC review the service, which had not been reviewed since 2001, for direct PE inputs. The RUC did not recommend a work RVU for CPT code 93668 due to the belief that there is no physician work involved in this service. After reviewing this code, we proposed a work RVU of 0.00 for CPT code 93668 and proposed to continue valuing the code for PE only.
The following is a summary of the public comments we received on our proposals involving CPT code 93688.
After consideration of the public comments received, we are finalizing the RUC-recommended work RVUs and direct PE inputs for CPT code 93668 as proposed.
CPT codes 95800 (Sleep study, unattended, simultaneous recording; heart rate, oxygen saturation, respiratory analysis (
For CPT code 95800, the RUC recommended a work RVU of 1.00 based on the survey 25th percentile value. We disagreed with the recommended value and proposed a work RVU of 0.85 based on a pair of crosswalk codes: CPT code 93281 (Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional; multiple lead pacemaker system) and CPT code 93260 (Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional; implantable subcutaneous lead defibrillator system). Both of these codes have a work RVU of 0.85, as well as having the same intraservice time of 15 minutes, similar total times to CPT code 95800, and recent review dates within the last few years.
In reviewing CPT code 95800, we noted that the recommended intraservice time is decreasing from 20 minutes to 15 minutes (25 percent reduction), and the recommended total time is decreasing from 50 minutes to 31 minutes (38 percent reduction); however, the RUC-recommended work RVU is only decreasing from 1.05 to 1.00, which is a reduction of less than 5 percent. Although we did not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should be reflected in decreases to work RVUs. In the case of CPT code 95800, we believe that it would be more accurate to propose a work RVU of 0.85
For CPT code 95801, the RUC proposed a work RVU of 1.00 again based on the survey 25th percentile. We disagreed with the recommended value and we proposed a work RVU of 0.85 based on the same pair of crosswalk codes, CPT codes 93281 and 93260. We noted that CPT codes 95800 and 95801 had identical recommended work RVUs and identical recommended survey work times. Given that these two codes also have extremely similar work descriptors, we interpreted this to mean that the two codes could have the same work RVU, and therefore, we proposed the same work RVU of 0.85 for both codes.
For CPT code 95806, the RUC recommended a work RVU of 1.08 based on a crosswalk to CPT code 95819 (Electroencephalogram (EEG); including recording awake and asleep). Although we disagreed with the RUC-recommended work RVU of 1.08, we concurred that the relative difference in work between CPT codes 95800 and 95801 and CPT code 95806 was equivalent to the recommended interval of 0.08 RVUs. Therefore, we proposed a work RVU of 0.93 for CPT code 95806, based on the recommended interval of 0.08 additional RVUs above our proposed work RVU of 0.85 for CPT codes 95800 and 95801. We also noted that CPT code 95806 is experiencing a similar change in the recommended work and time values comparable to CPT code 95800. The recommended intraservice time for CPT code 95806 is decreasing from 25 minutes to 15 minutes (40 percent), and the recommended total time is decreasing from 50 minutes to 31 minutes (38 percent); however, the recommended work RVU is only decreasing from 1.25 to 1.08, which is a reduction of only 14 percent. As we stated for CPT code 95800, we do not believe that decreases in work time must equate to a one-to-one or linear decrease in the valuation of work RVUs, but we do believe that these changes in surveyed work time suggest that practitioners are becoming more efficient at performing the procedure, and that it would be more accurate to maintain the recommended work interval with CPT codes 95800 and 95801 by proposing a work RVU of 0.93 for CPT code 95806.
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on our proposals involving the Home Sleep Apnea Testing family of codes.
After consideration of the public comments, we are finalizing the work RVUs and the direct PE inputs for the codes in the Home Sleep Apnea Testing family of codes as proposed.
In October 2013, CPT code 95971 (Electronic analysis of implanted neurostimulator pulse generator system; simple spinal cord, or peripheral (
The RUC recommended a work RVU of 0.45 for CPT code 95970 (Electronic analysis of implanted neurostimulator pulse generator/transmitter (
We disagreed with the RUC's recommendation because we did not believe that maintaining the work RVU, given a decrease of four minutes in total time, was appropriate. In addition, we noted that the reference CPT codes chosen have much higher intraservice and total times than CPT code 95970, and also have higher work RVUs, making them poor comparisons. Instead, we identified a crosswalk to CPT code 95930 (Visual evoked potential (VEP) checkerboard or flash testing, central nervous system except glaucoma, with interpretation and report) with 10 minutes intraservice time, 14 minutes total time, and a work RVU of 0.35. Therefore, we proposed a work RVU of 0.35 for CPT code 95970.
CPT code 95976 (Electronic analysis of implanted neurostimulator pulse generator/transmitter (
We disagreed with the RUC's recommended work RVU for this CPT code because we did not believe that the large difference in time between the new CPT code and CPT code 95974 was reflected in the slightly smaller proportional decrease in work RVUs. The reduction in total time, from 110 minutes to 24 minutes is nearly 80 percent. However, the RUC's recommended work RVU reflects a reduction of just under 70 percent. We believe that a more appropriate crosswalk would be CPT code 76641 (Ultrasound, breast, unilateral, real time with image documentation, including axilla when performed; complete) with intraservice time of 12 minutes, total time of 22 minutes, and a work RVU of 0.73. Therefore, we proposed a work RVU of 0.73 for CPT code 95976.
CPT code 95977 describes the same work as CPT code 95976, but with complex rather than simple programming. The CPT Editorial Panel refers to simple programming of a neurostimulator pulse generator/transmitter as the adjustment of one to three parameter(s), while complex programming includes adjustment of more than three parameters. For purposes of applying the building block methodology and calculating intraservice and total time ratios, the RUC compared CPT code 94X84 with CPT code 95975 (Electronic analysis of implanted neurostimulator pulse generator system (
We disagreed with the RUC's recommended work RVU of 1.19 for CPT code 95977. Once the comparison CPT code is corrected to CPT code 95974, the reverse building block calculation indicates that a lower work RVU (close to 0.82) would be a better reflection of the work involved in furnishing this service. As an alternative to the RUC's recommendation, we added the difference in RUC-recommended work RVUs between CPT codes 95976 and 95977 (0.24 RVUs) to the proposed work RVU of 0.73 for CPT code 95976. Therefore, we proposed a work RVU of 0.97 for CPT code 95977.
CPT code 95983 (Electronic analysis of implanted neurostimulator pulse generator/transmitter (
We disagreed with the RUC's recommended work RVU for CPT code 95983 because we did not believe that the reduction in work RVU reflected the change in time described by the CPT code. Using the reverse building block methodology, we estimated that a work RVU of nearer to 1.11 would be more appropriate. In addition, if we were to sum the RUC-recommended RVUs for a single hour of programming using one of the base CPT codes and three of the 15 minute follow-on CPT codes, 1 hour of programming would be valued at 4.25 work RVUs. This contrasts sharply from the work RVU of 3.50 for 1 hour of programming using the deleted CPT code 95978. We believe that a more appropriate valuation of the work involved in furnishing this service is reflected by a crosswalk to CPT code 93886 (Transcranial Doppler study of the intracranial arteries; complete study), with total time 27 minutes, intraservice time of 17 minutes, and a work RVU of 0.91. Therefore, we proposed a work RVU of 0.91 for CPT code 95983.
The RUC's recommended work RVU of 1.00 for CPT code 95984 is based on the key reference service CPT code 64645 (Chemodenervation of one extremity; each additional extremity, 5 or more muscles), which has total time of 26 minutes, intraservice time of 25 minutes, and a work RVU 1.39. This new CPT code is replacing CPT code 95978 (Electronic analysis of implanted neurostimulator pulse generator system (
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on our proposals involving the Neurostimulator Services family of codes.
As we have stated in the past, we believe that practitioners become more efficient at furnishing some services over time, shortening the amount of clinical time required. We still believe this is the case with regard to CPT code 95970, which has decreased in time without a significant change in intensity. We maintain that our crosswalk to CPT code 95930 with a work RVU of 0.35 for this CPT code is appropriate.
After consideration of the public comments, we are finalizing the work RVUs and direct PE inputs for the codes in the Neurostimulator Services family of codes as proposed.
In CY 2016, the Psychological and Neuropsychological Testing family of codes were identified as potentially misvalued using a high expenditure services screen across specialties with Medicare allowed charges of $10 million or more. The entire family of codes was referred to the CPT Editorial Panel to be revised, as the testing practices had been significantly altered by the growth and availability of technology, leading to confusion about how to report the codes. In June 2017, the CPT Editorial Panel revised five existing codes, added 13 codes to provide better description of psychological and neuropsychological testing, and deleted CPT codes 96101, 96102, 96103, 96111, 96118, 96119, and 96120. The RUC and HCPAC submitted recommendations for the 13 new codes and for the existing CPT codes 96105, 96110, 96116, 96125, and 96127.
We proposed the RUC- and HCPAC-recommend work RVUs for several of the CPT codes in this family: A work RVU of 1.75 for CPT code 96105; a work RVU of 1.86 for CPT code 96116; a work RVU of 1.70 for CPT code 96125; a work RVU of 1.71 for CPT code 96121; a work RVU of 0.55 for CPT code 96136; a work RVU of 0.46 for CPT code 96137; and a work RVU of 0.51 for CPT code 96X11. CPT codes 96110, 96127, 96138, 96139, and 96146 were valued by the RUC for PE only.
This code family contains a subset of codes that describe psychological and neuropsychological testing administration and evaluation, not including assessment of aphasia, developmental screening, or developmental testing. The CPT Editorial Panel's recommended coding for this subset of services consists of seven new codes: Two that describe either psychological or neuropsychological testing when administered by physicians or other qualified health professionals (CPT codes 96136 and 96137), and two for either type of testing when administered by technicians (CPT codes 96138 and 96139); and four new codes that describe testing evaluation by physicians or other qualified health care professionals (CPT codes 96130 through 96133). This new coding effectively unbundles codes that currently report the full course of testing into separate codes for testing administration (CPT codes 96136, 96137, 96138, and 96139) and evaluation (CPT codes 96130, 96131, and 96132). According to a stakeholder that represents the psychologist and neuropsychologist community, this new coding will result in significant reductions in payment for these services due to the unbundling of the testing codes into codes for physician-administered tests and technician-administered tests. The stakeholder noted that because the new coding includes testing codes with zero work RVUs for the technician administered tests and the work RVUs are lower than they believe to be accurate, this new valuation would ignore the clinical evaluation and decision making performed by the physician or other qualified health professional during the course of testing administration and evaluation. Furthermore, the net result of the code valuations for these new codes is a reduction in the overall work RVUs for this family of codes. In other words, the stakeholder's analysis found that the RUC recommendations result in a reduction in total work RVUs, even though the actual physician work of a testing battery has not changed.
In the interest of payment stability for these high-volume services, we proposed to implement work RVUs for this code family, which would eliminate the approximately 2 percent reduction in work spending. We proposed to achieve work neutrality for this code family by scaling the work RVUs upward from the RUC-recommended values so that the size of the pool of work RVUs would be essentially unchanged for this family of services. Therefore, we proposed: A work RVU of 2.56 for CPT code 96112, rather than the RUC-recommended work RVU of 2.50; a work RVU of 1.16 for CPT code 96113, rather than the RUC-recommended work RVU of 1.10; a work RVU of 2.56 for CPT code 96130, rather than the RUC-recommended work RVU of 2.50; a work RVU of 1.96 for CPT code 96131, rather than the RUC-recommended work RVU of 1.90; a work RVU of 2.56 for CPT code 96132, rather than the RUC-recommended work RVU of 2.50; and a work RVU of 1.96 for CPT code 96133, rather than the RUC-recommended work RVU of 1.90. We saw no evidence that the typical practice for these services has changed to merit a reduction in valuation of professional services.
The RUC made several revisions to the recommended direct PE inputs for the administration codes from their respective predecessor codes, including revisions to quantities of testing forms. For the supply item, “psych testing forms, average” there is a quantity of 0.10 in the predecessor CPT code 96101, and a quantity of 0.33 in the predecessor CPT code 96102. For the supply item “neurobehavioral status forms, average,” there is a quantity of 1.0 in the predecessor CPT code 96118 and a quantity of 0.30 for predecessor CPT code 96119, and for the supply item “aphasia assessment forms, average,” there is a quantity of 1.0 in the predecessor CPT code 96118 and a quantity of 0.30 in predecessor CPT code 96119. The RUC recommendation does not include any forms for CPT codes 96132 and 96133. The RUC has replaced the corresponding predecessor supply items with new items “WAIS-IV Record Form,” “WAIS-IV Response Booklet #1,” and “WAIS-IV Response Booklet #2,” and assigned quantities of 0.165 for each of these new supply items for CPT codes 96136 through 96139. In our analysis, we found that the RUC-recommended direct PE refinements contributed significantly to the reduction in the overall payment for this code family. We saw no compelling evidence that the quantities of testing forms used in a typical course of testing would have been reduced dramatically and, in the interest of payment stability, we proposed to refine the direct PE inputs for CPT codes 96132 through 96139 by including 1.0 quantity each of the supply items “WAIS-IV Record
We also proposed to remove the equipment time for the CANTAB Mobile (ED055) equipment item from CPT code 96146. This item was listed at different points in the recommendations as a supply item with a cost of $28 per assessment and as an equipment item for a software license with a cost of $2,800 that could be used for up to 100 assessments. We were unclear as to how the CANTAB Mobile would typically be used in this procedure, and we proposed to remove the equipment time pending the submission of more data about the item. We solicited additional information about the use of this item and how it should best be included into the PE methodology. We were also interested in information as to whether the submitted invoice refers to the cost of the mobile device itself, or the cost of user licenses for the mobile device, which was unclear from the information submitted with the recommendations.
The following is a summary of the comments we received regarding our proposed work RVUs and proposed direct PE refinements for this family of services.
According to some commenters, some psychologists will see slight decreases for neuropsychological testing services due to the new coding structure, which they say aligns psychological and neuropsychological testing services with other testing services in the program. Some commenters said that, due to the new coding structure, reimbursement will be lower for neuropsychological evaluation services that are provided by physicians than those provided by technicians. These commenters stated that physicians should not be reimbursed at a lesser rate than EEG or MRI technicians or other physician extenders.
After consideration of the public comments, we are finalizing the work RVUs for the codes in the Psychological and Neuropsychological Testing family of codes as proposed. We are also finalizing the direct PE inputs as proposed, with the exception of the refinement to the CA021 clinical labor for CPT codes 96136 and 96137 as detailed above.
CPT Code 95829 is used for Electrocorticogram performed at the time of surgery; however, a new code was needed to account for this non-face-to-face service for the review of a month's worth or more of stored data. CPT code 95836 (Electrocorticogram from an implanted brain neurostimulator pulse generator/transmitter, including recording, with interpretation and written report, up to 30 days) is a new code approved at the September 2017 CPT Editorial Panel Meeting to describe this service.
We disagreed with the RUC-recommended work RVU of 2.30 for CPT code 95836 and proposed a work RVU of 1.98 based on a direct crosswalk to the top reference, CPT code 95957 (Digital analysis of electroencephalogram (EEG) (
The RUC did not recommend, and we did not propose, any direct PE inputs for CPT code 95836.
The following is a summary of the public comments we received on our proposals involving CPT code 95836.
After consideration of the public comments, we are finalizing the work RVU for CPT code 95836 as proposed. We are not finalizing any direct PE inputs for this code, but we will value it in both the facility and nonfacility settings as noted above.
In the CY 2018 PFS final rule, we finalized separate payment for CPT code 99091 (Collection and interpretation of physiologic data (
CPT codes 99453 (Remote monitoring of physiologic parameter(s) (
For the direct PE inputs, we proposed to accept the RUC-recommended direct PE inputs for CPT code 99453 and to remove the “Monthly cellular and licensing service fee” supply from CPT code 99454. We do not believe that these licensing fees will be allocated to the use of an individual patient for an individual service, and instead believe they can be better understood as forms of indirect costs similar to office rent or administrative expenses. Therefore, we proposed to remove this supply input as a form of indirect PE. We proposed the direct PE inputs for CPT code 99457 without refinement.
The following is a summary of the public comments we received on our
After considering the public comments, we are finalizing the RUC-recommended work RVU of 0.61 for CPT code 99457 and the direct PE inputs for all three codes as proposed.
In September 2017, the CPT Editorial Panel revised four codes and created two codes to describe interprofessional telephone/internet/electronic medical record consultation services. CPT codes 99446 (Interprofessional telephone/internet assessment and management service provided by a consultative physician including a verbal and written report to the patient's treating/requesting physician or other qualified health care professional; 5-10 minutes of medical consultative discussion and review), 99447 (Interprofessional telephone/internet assessment and management service provided by a consultative physician including a verbal and written report to the patient's treating/requesting physician or other qualified health care professional; 11-20 minutes of medical consultative discussion and review), 99448 (Interprofessional telephone/internet assessment and management service provided by a consultative physician including a verbal and written report to the patient's treating/requesting physician or other qualified health care professional; 21-30 minutes of medical consultative discussion and review), and 99449 (Interprofessional telephone/internet assessment and management service provided by a consultative physician including a verbal and written report to the patient's treating/requesting physician or other qualified health care professional; 31 minutes or more of medical consultative discussion and review) describe assessment and management services in which a patient's treating physician or other qualified healthcare professional requests the opinion and/or treatment advice of a physician with specific specialty expertise to assist with the diagnosis and/or management of the patient's problem without the need for the face-to-face interaction between the patient and the consultant. These CPT codes are currently assigned a procedure status of B (bundled) and are not separately payable under Medicare. The CPT Editorial Panel revised these codes to include electronic health record consultations, and the RUC reaffirmed the work RVUs it had previously submitted for these codes. We reevaluated the submitted recommendations and, in light of changes in medical practice and technology, we proposed to change the procedure status for CPT codes 99446, 99447, 99448, and 99449 from B (bundled) to A (active). We also proposed the RUC re-affirmed work RVUs of 0.35 for CPT code 99446, 0.70 for CPT code 99447, 1.05 for CPT code 99448, and 1.40 for CPT code 99449.
The CPT Editorial Panel also created two new codes, CPT code 99452 (Interprofessional telephone/internet/electronic health record referral service(s) provided by a treating/requesting physician or qualified health care professional, 30 minutes) and CPT code 99451 (Interprofessional telephone/internet/electronic health record assessment and management service provided by a consultative physician including a written report to the patient's treating/requesting physician or other qualified health care professional, 5 or more minutes of medical consultative time). The RUC-recommended work RVUs are 0.50 for CPT code 99452 and 0.70 for 99451. Since the CPT code for the treating/requesting physician or qualified healthcare professional and the CPT code for the consultative physician have similar intraservice times, we believe that these CPT codes should have equal values for work. Therefore, we proposed a work RVU of 0.50 for both CPT codes 99452 and 99451.
We welcomed comments on this proposal. We also direct readers to section II.D. of this final rule, Modernizing Medicare Physician Payment by Recognizing Communication Technology-Based Services, which includes additional detail regarding our policies for modernizing Medicare physician payment by recognizing communication technology-based services.
There are no recommended direct PE inputs for the codes in this family.
The following is a summary of the public comments we received on our proposals involving the Interprofessional Internet Consultation family of codes.
In February 2017, the CPT Editorial Panel created a new code to describe at least 30 minutes of chronic care management services performed personally by the physician or qualified health care professional over one calendar month. CMS began making separate payment for CPT code 99490 (Chronic care management services, at least 20 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month, with the following required elements: Multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient; chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline; comprehensive care plan established, implemented, revised, or monitored) in CY 2015 (79 FR 67715). CPT code 99490 describes 20 minutes of clinical staff time spent on care management services for patients with 2 or more chronic conditions. CPT code 99490 also includes 15 minutes of physician time for supervision of clinical staff. For CY 2019, the CPT Editorial Panel created CPT code 99491 (Chronic care management services, provided personally by a physician or other qualified health care professional, at least 30 minutes of physician or other qualified health care professional time, per calendar month, with the following required elements: Multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient, chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline; comprehensive care plan established, implemented, revised, or monitored) to describe situations when the billing practitioner is doing the care coordination work that is attributed to clinical staff in CPT code 99490. For CPT code 99491, the RUC recommended a work RVU of 1.45 for 30 minutes of physician time.
We believe this work RVU overvalues the resource costs associated with the physician performing the same care coordination activities that are performed by clinical staff in the service described by CPT code 99490. Additionally, this valuation of the work is higher than that of CPT code 99487 (Complex chronic care management services, with the following required elements: Multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient, chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline, establishment or substantial revision of a comprehensive care plan, moderate or high complexity medical decision making; 60 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month), which includes 60 minutes of clinical staff time, creating a rank order anomaly within the family of codes if we were to accept the RUC-recommended value.
CPT code 99490 has a work RVU of 0.61 for 15 minutes of physician time. Therefore, as CPT code 99491 describes 30 minutes of physician time, we proposed a work RVU of 1.22, which is double the work RVU of CPT code 99490.
We did not propose any direct PE refinements for this code family.
The following is a summary of the public comments we received on our proposals involving CPT code 99491.
HCPCS codes G0108 (Diabetes outpatient self-management training services, individual, per 30 minutes) and G0109 (Diabetes outpatient self-
For the direct PE inputs, we noted that there was a significant disparity between the specialty recommendation and the final recommendation submitted by the HCPAC. We were concerned about the significant decreases in direct PE inputs in the final recommendation when compared to the current makeup of the two codes. The final HCPAC recommendation removed a series of different syringes and the patient education booklet that currently accompanies the procedure. We believe that injection training is part of these services and that the supplies associated with that training would typically be included in the procedures. Due to these concerns, we proposed to maintain the current direct PE inputs for HCPCS codes G0108 and G0109. Therefore, we proposed not to add the new supply item “20x30 inch self-stick easel pad, white, 30 sheets/pad” (SK129) to HCPCS code G0109 that was included in the final HCPAC recommendation, as it was not a current supply for HCPCS code G0109; however, we proposed to accept the submitted invoice price and to add the supply to our direct PE database.
The following is a summary of the public comments we received on our proposals involving the Diabetes Management Training family of codes.
After consideration of the public comments, we are finalizing the work RVUs and the direct PE inputs for the codes in the Diabetes Management Training family of codes as proposed.
HCPCS code G0166 (External counterpulsation, per treatment session) was identified on a screen of CMS or Other source codes with Medicare utilization greater than 100,000 services annually. The RUC is not recommending a work RVU for HCPCS code G0166 because they found that there is no physician work involved in this service. After reviewing this code, we proposed a work RVU of 0.00 for HCPCS code G0166, and proposed to make the code valued for PE only. For the direct PE inputs, we proposed to refine the equipment times in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on our proposals involving HCPCS code G0166.
After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for HCPCS code G0166 as proposed.
HCPCS code G0168 (Wound closure utilizing tissue adhesive(s) only) was identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. For CY 2019, the RUC recommended a work RVU of 0.45 based on maintaining the current work RVU.
We disagreed with the recommended value and we proposed a work RVU of 0.31 for HCPCS code G0168 based on a direct crosswalk to CPT code 93293 (Transtelephonic rhythm strip pacemaker evaluation(s) single, dual, or multiple lead pacemaker system, includes recording with and without magnet application with analysis, review and report(s) by a physician or other qualified health care professional, up to 90 days). CPT code 93293 is a recently-reviewed code with the same 5 minutes of intraservice time and 1 fewer minute of total time. In reviewing HCPCS code G0168, the recommendations stated that the work involved in the service had not changed even though the surveyed intraservice time was decreasing by 50 percent, from 10 minutes to 5 minutes. Although we did not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should be reflected in decreases to work RVUs. In the case of HCPCS code G0168, we believe that it would be more accurate to propose a work RVU of 0.31 based on
For the direct PE inputs, we proposed to refine the equipment times in accordance with our standard equipment time formulas.
The following is a summary of the public comments we received on our proposals involving HCPCS code G0168.
After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for HCPCS code G0168 as proposed.
HCPCS code G0268 (Removal of impacted cerumen (one or both ears) by physician on same date of service as audiologic function testing) was identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. For CY 2019, we proposed the RUC-recommended work RVU of 0.61 for HCPCS code G0268.
For the direct PE inputs, we proposed to remove the clinical labor time for the “Clean surgical instrument package” (CA026) activity. There is no surgical instrument pack included in the recommended equipment for HCPCS code G0268, and this code already includes the standard 3 minutes allocated for cleaning the room and equipment. In addition, all of the instruments used in the procedure appear to be disposable supplies that would not require cleaning since they would only be used a single time.
The following is a summary of the public comments we received on our proposals involving HCPCS code G0268.
After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for HCPCS code G0268 as proposed.
In response to the Request for Information in the CY 2018 PFS proposed rule (82 FR 34172), commenters requested that CMS pay separately for assessment and referral related to substance use disorders. In the CY 2008 PFS final rule (72 FR 66371), we created two G-codes to allow for appropriate Medicare reporting and payment for alcohol and substance abuse assessment and intervention services that are not provided as screening services, but that are performed in the context of the diagnosis or treatment of illness or injury. The codes are HCPCS code G0396 (Alcohol and/or substance (other than tobacco) abuse structured assessment (
Given the ongoing opioid epidemic and the current needs of the Medicare population, we expect that these services would often be reasonable and necessary. However, the utilization for these services is relatively low, which we believe is in part due to the service-specific documentation requirements for these codes (the current requirements are available at
The following is a summary of the comments we received regarding our proposal to change the documentation requirements for these codes.
Additionally, we proposed to create a third HCPCS code G2011with a lower time threshold in order to accurately account for the resource costs when practitioners furnish these services, but do not meet the minimum time requirements of the existing codes. We note that in the proposed rule we referred to this service as HCPCS code GSBR1, which was a placeholder code. The code will be described as G2011: Alcohol and/or substance (other than tobacco) abuse structured assessment (
The following is a summary of the comments we received on this code descriptor and proposed valuation for HCPCS code G2011.
CPT codes 99354 (Prolonged evaluation and management or psychotherapy service(s) (beyond the typical service time of the primary procedure) in the office or other outpatient setting requiring direct patient contact beyond the usual service; first hour (List separately in addition to code for office or other outpatient Evaluation and Management or psychotherapy service)) and 99355 (Prolonged evaluation and management or psychotherapy service(s) (beyond the typical service time of the primary procedure) in the office or other outpatient setting requiring direct patient contact beyond the usual service; each additional 30 minutes (List separately in addition to code for prolonged service)) describe additional time spent face-to-face with a patient. Stakeholders have shared with us that the threshold of 60 minutes for CPT code 99354 is difficult to meet and is an impediment to billing these codes. In response to stakeholder feedback and as part of our proposal as discussed in section II.I. of this final rule, Evaluation and Management Services, to implement a single PFS rate for E/M visit levels 2-5 while maintaining payment stability across the specialties, we proposed HCPCS code GPRO1 (Prolonged evaluation and management or psychotherapy service(s) (beyond the typical service time of the primary procedure) in the office or other outpatient setting requiring direct patient contact beyond the usual service; 30 minutes (List separately in addition to code for office or other outpatient Evaluation and Management or psychotherapy service)), which could be billed with any level of E/M code. We noted that we did not propose to make any changes to CPT codes 99354 and 99355, which can still be billed, as needed, when their time thresholds and all other requirements are met. We proposed a work RVU of 1.17, which is equal to half of the work RVU assigned to CPT code 99354. Additionally, we proposed direct PE inputs for HCPCS code GPRO1 that are equal to one half of the values assigned to CPT code 99354, which can be found in the Direct PE Inputs public use file for this final rule.
For CY 2019, we proposed to make separate payment for remote evaluation services when a physician uses pre-recorded video and/or images submitted by a patient in order to evaluate a patient's condition through new HCPCS G-code G2010 (Remote evaluation of recorded video and/or images submitted by the patient (
The following is a summary of the comments we received on the code descriptor and valuation for HCPCS code G2010.
After considering the public comments, we are finalizing the work RVU and direct PE inputs for HCPCS code G2010 as proposed.
We proposed to create a G-code, HCPCS code G2012 (Brief communication technology based service,
The following is a summary of the comments we received on the code descriptor, as well as the proposed valuation for HCPCS code G2012.
We plan to monitor the utilization of this code and note that we routinely address recommended changes in values for codes paid under the PFS and would expect to do this in future rulemaking.
After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for HCPCS code G2012 as proposed.
We proposed to create a HCPCS G-code to be reported with an E/M service to describe the additional resource costs for specialties for whom E/M visit codes make up a large percentage of their total allowed charges and who we believe primarily bill level 4 and level 5 visits. The treatment approaches for these specialties generally do not have separate coding and are generally reported using the E/M visit codes. We proposed to create HCPCS code, GCG0X (Visit complexity inherent to evaluation and management associated with endocrinology, rheumatology, hematology/oncology, urology, neurology, obstetrics/gynecology, allergy/immunology, otolaryngology, or
The following is a summary of the comments we received on the code descriptor, as well as the proposed valuation for HCPCS code GCG0X.
We proposed to create a HCPCS G-code for primary care services, GPC1X (Visit complexity inherent to evaluation and management associated with primary medical care services that serve as the continuing focal point for all needed health care services (Add-on code, list separately in addition to an evaluation and management visit)). This code describes furnishing a visit to a new or existing patient, and can include aspects of care management, counseling, or treatment of acute or chronic conditions not accounted for by other coding. HCPCS code GPC1X would be billed in addition to the E/M visit code when the visit involved primary care-focused services. We proposed a work RVU of 0.07, physician time of 1.75 minutes. This proposed valuation accounts for the additional work resource costs associated with furnishing primary care that distinguishes E/M primary care visits from other types of E/M visits and maintains work budget neutrality across the office/outpatient E/M code set. For further discussion of proposals relating to this code, see section II.I. of this final rule. We solicited comment on the code descriptor, as well as the proposed valuation for HCPCS code GPC1X.
The following is a summary of the comments we received on the code descriptor, as well as the proposed valuation for HCPCS code GPC1X.
We proposed to create two HCPCS G-codes, HCPCS codes GPD0X (Podiatry services, medical examination and evaluation with initiation of diagnostic and treatment program, new patient) and GPD1X (Podiatry services, medical examination and evaluation with initiation of diagnostic and treatment program, established patient), to describe podiatric evaluation and management services. We proposed a work RVU of 1.36, a physician time of 28.19 minutes, and direct costs summing to $21.29 for HCPCS code GPD0X, and a work RVU of 0.85, physician time of 21.73 minutes, and direct costs summing to $15.87 for HCPCS code GPD1X. These values are based on the average rate for CPT codes 99201-99203 and CPT codes 99211-99212 respectively, weighted by podiatric volume. For further discussion of proposals relating to these codes, see section II.I. of this final rule.
In the CY 2015 PFS final rule with comment period (79 FR 67666 through 67667), we noted that changes to the CPT prefatory language limited the codes that could be reported when describing services associated with superficial radiation treatment (SRT) delivery, described by CPT code 77401 (radiation treatment delivery, superficial and/or ortho voltage, per day). The changes effectively meant that many other related services were bundled with CPT code 77401, instead of being separately reported. For example, CPT guidance clarified that certain codes used to describe clinical treatment planning, treatment devices, isodose planning, physics consultation, and radiation treatment management cannot be reported when furnished in association with SRT. Stakeholders informed us that these changes to the CPT prefatory language prevented them from billing Medicare for codes that were previously frequently billed with CPT code 77401. We solicited comments as to whether the revised bundled coding for SRT allowed for accurate reporting of the associated services. In the CY 2016 PFS final rule with comment period (80 FR 70955), we noted that the RUC did not review the inputs for SRT procedures, and therefore, did not assess whether changes in valuation were appropriate in light of the bundling of associated services. In addition, we solicited recommendations from stakeholders regarding whether it would be appropriate to add physician work for this service, even though physician work is not included in other radiation treatment services. In the CY 2018 PFS proposed rule (82 FR 34012) and the CY 2018 PFS final rule (82 FR 53082), we noted that the 2016 National Correct
Given stakeholder feedback that we have continued to receive following the publication of the CY 2018 PFS final rule, we continue to believe that there are potential coding gaps for SRT-related professional services. We generally rely on the CPT process to determine coding specificity, and we believe that deferring to this process in addressing potential coding gaps is generally preferable. As our previous attempt at designing a coding solution in the CY 2018 PFS proposed rule did not gain stakeholder consensus, and given that there were various, in some cases diverging, suggestions on a coding solution from stakeholders, we did not propose changes relating to SRT coding, SRT-related professional codes, or payment policies for CY 2019. However, we solicited comment on the possibility of creating multiple G-codes specific to services associated with SRT, as was suggested by one stakeholder following the CY 2018 PFS final rule. These codes would be used separately to report services including SRT planning, initial patient simulation visit, treatment device design and construction associated with SRT, SRT management, and medical physics consultation. We solicited comment on whether we should create such G-codes to separately report each of the services described previously, mirroring the coding of other types of radiation treatment delivery. For instance, HCPCS code G6003 (Radiation treatment delivery, single treatment area, single port or parallel opposed ports, simple blocks or no blocks: Up to 5 mev) is used to report radiation treatment delivery, while associated professional services are billed with codes such as CPT codes 77427 (Radiation treatment management, 5 treatments), 77261 (Therapeutic radiology treatment planning; simple), 77332 (Treatment devices, design and construction; simple (simple block, simple bolus), and 77300 (Basic radiation dosimetry calculation, central axis depth dose calculation, TDF, NSD, gap calculation, off axis factor, tissue inhomogeneity factors, calculation of non-ionizing radiation surface and depth dose, as required during course of treatment, only when prescribed by the treating physician).
We stated that we consider contractor pricing such codes for CY 2019 because we believe that the preferable method to develop new coding is with multi-specialty input through the CPT and RUC process, and we prefer to defer nationally pricing such codes pending input from the CPT Editorial Panel and the RUC process to assist in determining the appropriate level of coding specificity for SRT-related professional services. Based on stakeholder feedback, we continue to believe there may be a coding gap for these services, and therefore, we solicited comment on whether we should create these G-codes and allow them to be contractor priced for CY 2019. This would be an interim approach for addressing the potential coding gap until the CPT Editorial Panel and the RUC can address coding for SRT and SRT-related professional services, giving the CPT Editorial Panel and the RUC an opportunity to develop a coding solution that could be addressed in future rulemaking.
The following is a summary of the comments we received on the possibility of creating multiple G-codes specific to services associated with SRT, which could be used separately to report services including SRT planning, initial patient simulation visit, treatment device design and construction associated with SRT, SRT management, and medical physics consultation, which would be contractor priced for CY 2019.
Some commenters recommended implementation of G-codes for SRT-related professional services, and they submitted alternative G-code scenarios that they believe would be preferable to adopting contractor-priced G-codes. These scenarios include one in which there would be one code for SRT-related treatment planning, with a value based on a crosswalk to CPT code 77261 (Therapeutic radiology treatment planning; simple), a code for SRT treatment device construction, with a value based on a crosswalk to CPT code 77332 (Treatment devices, design and construction; simple (simple block, simple bolus), and a code for SRT treatment management billed once per treatment, valued with a crosswalk to CPT code 99213 (Office or other outpatient visit for the evaluation and management of an established patient,
A commenter stated that any codes utilized as part of superficial radiation treatment delivery that include medical physics time should require that a qualified medical physicist perform the physics work.
A commenter stated that adopting contractor-priced G codes would be appropriate. Some other commenters, however, did not support our suggested adoption of contractor-priced codes. According to these commenters, we are correct in our belief that there are coding gaps in the current reimbursement structure, however a fuller evaluation that does not defer to Medicare contractors in determining reimbursement rates is appropriate. According to a commenter, contractor pricing creates unnecessary work for the Medicare Administrative Contractors and can also lead to wide variances in the valuing of codes across jurisdictions. Commenters expressed preference that coding for these services be developed through the CPT and RUC processes. Many commenters urged us not to change coding for CY 2019 for these services.
We note that we intended to assign a contractor price status in the Addendum B file of the proposed rule for the following CPT codes that describe adaptive behavior analysis services: CPT codes 97151, 97152, 97153, 97154, 97155, 97156, 97157, and 97158. These codes are formerly contractor priced Category III CPT codes that were converted to Category I for CY 2019. We inadvertently excluded these codes in the Addendum B file of the proposed rule, and have updated the Addendum B file for this final rule.
Physicians and other practitioners paid under the PFS bill for common office visits for evaluation and management (E/M) services under a relatively generic set of CPT codes (Level I HCPCS codes) that distinguish visits based on the level of complexity, site of service, and whether the patient is new or established. The CPT codes have three key components:
• History of Present Illness (History),
• Physical Examination (Exam) and
• Medical Decision Making (MDM).
These codes are broadly referred to as E/M visit codes. There are three to five E/M visit code levels, depending on site of service and the extent of the three components of history, exam and MDM. For example, there are three to four levels of E/M visit codes in the inpatient hospital and nursing facility settings, based on a relatively narrow degree of complexity in those settings. In contrast, there are five levels of E/M visit codes in the office or other outpatient setting based on a broader range of complexity in those settings.
Current PFS payment rates for E/M visit codes increase with the level of visit billed. As for all services under the PFS, the rates are based on the resources in terms of work (time and intensity), PE and malpractice expense required to furnish the typical case of the service. The current payment rates reflect typical service times for each code that are based on RUC recommendations.
In total, E/M visits comprise approximately 40 percent of allowed charges for PFS services, and office/outpatient E/M visits comprise approximately 20 percent of allowed charges for PFS services. Within these percentages, there is significant variation among specialties. According to Medicare claims data, E/M visits are furnished by nearly all specialties, but represent a greater share of total allowed services for physicians and other practitioners who do not routinely furnish procedural interventions or diagnostic tests. Generally, these practitioners include both primary care practitioners and specialists such as neurologists, endocrinologists and rheumatologists. Certain specialties, such as podiatry, tend to furnish lower level E/M visits more often than higher level E/M visits. Some specialties, such as dermatology and otolaryngology, tend to bill more E/M visits on the same day as they bill minor procedures.
Potential misvaluation of E/M codes is an issue that we have been carefully considering for several years. We have discussed at length in our recent PFS proposed and final rules that the E/M visit code set is outdated and needs to be revised and revalued (for example: 81 FR 46200 and 76 FR 42793). We have noted that this code set represents a high proportion of PFS expenditures, but has not been recently revalued to account for significant changes in the disease burden of the Medicare patient population and changes in health care practice that are underway to meet the Medicare population's health care needs (81 FR 46200). In the CY 2012 PFS proposed rule, we proposed to refer all E/M codes to the RUC for review as potentially misvalued (76 FR 42793). Many commenters to that rule were concerned about the possible inadequacies of the current E/M coding and documentation structure to address evolving chronic care management and to support primary care (76 FR 73060 through 73064). We did not finalize our proposal to refer the E/M codes for RUC review at that time. Instead, we stated that we would allow time for consideration of the findings of certain demonstrations and other initiatives to provide improved information for the valuation of chronic care management, primary care, and care transitions. We stated that we would also continue to consider the numerous policy alternatives that commenters offered, such as separate E/M codes for established visits for patients with chronic disease versus a post-surgical follow-up office visit.
Many stakeholders continue to similarly express to us through letters, meetings, public comments in past rulemaking cycles, and other avenues, that the E/M code set is outdated and needs to be revised. For example, some stakeholders recommend an extensive research effort to revise and revalue E/M services, especially physician work inputs (CY 2017 PFS final rule, 81 FR 80227-80228). In recent years, we have continued to consider the best ways to recognize the significant changes in health care practice, especially innovations in the active management and ongoing care of chronically ill patients, under the PFS. We have been engaged in an ongoing, incremental effort to identify gaps in appropriate coding and payment.
For coding and billing E/M visits to Medicare, practitioners may use one of two versions of the E/M Documentation Guidelines for a patient encounter, commonly referenced based on the year of their release: the “1995” or “1997” E/M Documentation Guidelines. These guidelines are available on the CMS website.
According to both Medicare claims processing manual instructions and CPT coding rules, when counseling and/or coordination of care accounts for more than 50 percent of the face-to-face physician/patient encounter (or, in the case of inpatient E/M services, the floor time) the duration of the visit can be used as an alternative basis to select the appropriate E/M visit level (Pub. L. 100-04, Medicare Claims Processing Manual, Chapter 12, Section 30.6.1.C available at
Both the 1995 and 1997 E/M guidelines contain guidelines that address time, which state that “In the case where counseling and/or coordination of care dominates (more than 50 percent of) the physician/patient and/or family encounter (face-to-face time in the office or other outpatient setting or floor/unit time in the hospital or nursing facility), time is considered the key or controlling factor to qualify for a particular level of E/M services.” The guidelines go on to state that “If the physician elects to report the level of service based on counseling and/or coordination of care, the total length of time of the encounter (face-to-face or floor time, as appropriate) should be documented and the record should describe the counseling and/or activities to coordinate care.”
We note that other manual provisions regarding E/M visits that are cited in this final rule are housed separately within Medicare's Internet-Only Manuals, and are not contained within the 1995 or 1997 E/M documentation guidelines.
In accordance with section 1862(a)(1)(A) of the Act, which requires services paid under Medicare Part B to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, medical necessity is a prerequisite to Medicare payment for E/M visits. The Medicare Claims Processing Manual states, “Medical necessity of a service is the overarching criterion for payment in addition to the individual requirements of a CPT code. It would not be medically necessary or appropriate to bill a higher level of evaluation and management service when a lower level of service is warranted. The volume of documentation should not be the primary influence upon which a specific level of service is billed. Documentation should support the level of service reported” (Pub. L. 100-04, Medicare Claims Processing Manual, Chapter 12, Section 30.6.1.A., available on the CMS website at
Stakeholders have long maintained that all of the E/M documentation guidelines are administratively burdensome and outdated with respect to the practice of medicine. Stakeholders have provided CMS with examples of such outdated material (on history, exam and MDM) that can be found within all versions of the E/M guidelines (the AMA's CPT codebook, the 1995 guidelines and the 1997 guidelines). Stakeholders have told CMS that they believe the guidelines are too complex, ambiguous, fail to meaningfully distinguish differences among code levels, and are not updated for changes in technology, especially electronic health record (EHR) use. Prior attempts to revise the E/M guidelines were unsuccessful or resulted in additional complexity due to lack of stakeholder consensus (with widely varying views among specialties), and differing perspectives on whether code revaluation would be necessary under the PFS as a result of revising the guidelines, which contributed another layer of complexity to the considerations. For example, an early attempt to revise the guidelines resulted in an additional version designed for use by certain specialties (the 1997 version), and in CMS allowing the use of either the 1995 or 1997 versions for purposes of documentation and billing to Medicare. Another complication in revising the guidelines is that they are also used by many other payers, which have their own payment rules and audit protocols. Moreover, stakeholders have suggested that there is sometimes variation in how Medicare's own contractors (Medicare Administrative Contractors (MACs)) interpret and apply the guidelines as part of their audit processes.
As previously mentioned, in recent years, some clinicians and other stakeholders have requested a major CMS research initiative to overhaul not only the E/M documentation guidelines, but also the underlying coding structure and valuation. Stakeholders have reported to CMS that they believe the E/M visit codes themselves need substantial updating and revaluation to reflect changes in the practice of medicine, and that revising the documentation guidelines without addressing the codes themselves simply preserves an antiquated framework for payment of E/M services.
Last year, CMS sought public comment on potential changes to the E/M documentation rules, deferring making any changes to E/M coding itself in order to immediately focus on revision of the E/M guidelines to reduce unnecessary administrative burden (82 FR 34078 through 34080). In the CY 2018 PFS final rule (82 FR 53163 through 53166), we summarized the public comments we received and stated that we would take that feedback into consideration for future rulemaking. In response to commenters' request that we provide additional venues for stakeholder input, we held a listening session this year on March 18, 2018 (transcript and materials are available on the CMS website at
Several themes emerged from this recent stakeholder input. Stakeholders commended CMS for undertaking efforts to revise the E/M guidelines and recommended a multi-year process. Many commenters advised CMS to obtain further input across specialties. They recommended town halls, open door forums or a task force that would come up with replacement guidelines that would work for all specialties over the course of several years. They urged CMS to proceed cautiously given the magnitude of the undertaking; past failed reform attempts by the AMA, CMS, and other payers; and the wide-ranging impact of any changes (for example, how other payers approach the issue).
We received substantially different recommendations by specialty. Based on this feedback, it is clear that any changes would have meaningful specialty-specific impacts, both clinical and financial. Based on this feedback, it also seems that the history and exam portions of the guidelines are most significantly outdated with respect to current clinical practice.
A few stakeholders seemed to indicate that the documentation guidelines on history and exam should be kept in their current form. Many stakeholders believed they should be simplified or reduced, but not eliminated. Some stakeholders indicated that the documentation guidelines on history and exam could be eliminated altogether, and/or that documentation of these parts of an E/M visit could be left
Having considered the public feedback to the CY 2018 PFS proposed rule (82 FR 53163 through 53166) and our other outreach efforts described above, in our CY 2019 proposed rule, we proposed several changes to E/M visit documentation and payment. We proposed that the changes would only apply to office/outpatient visit codes (CPT codes 99201 through 99215), except where we specify otherwise. We agreed with commenters that we should take a step-wise approach to these issues, and therefore, we limited proposed changes to the office/outpatient E/M code set. We understood from commenters that there are more unique issues to consider for the E/M code sets used in other settings such as inpatient hospital or emergency department care, such as unique clinical and legal issues and the potential intersection with hospital Conditions of Participation (CoPs). We may consider expanding our efforts more broadly to address sections of the E/M code set beyond the office/outpatient codes in future years.
We emphasized that, this year, we included our proposed E/M documentation changes in a proposed rule due to the longstanding nature of our instruction that practitioners may use either the 1995 or 1997 versions of the E/M guidelines to document E/M visits billed to Medicare, the magnitude of the proposed changes, and the associated payment policy proposals that require notice and comment rulemaking. We believed our proposed documentation changes for E/M visits were intrinsically related to our proposal to alter PFS payment for E/M visits, and the PFS payment proposal for E/M visits required notice and comment rulemaking. We noted that we were proposing a relatively broad outline of changes, and anticipated that many details related to program integrity and ongoing refinement would need to be developed over time through subregulatory guidance. This would afford flexibility and enable us to more nimbly and quickly make ongoing clarifications, changes and refinements in response to continued practitioner experience moving forward.
We put forth a key proposal that, at its core, strived to reduce the significant burden associated with documentation for payment purposes by eliminating the payment rules associated with the current primary means of varying payment among office/outpatient visits. Specifically, we proposed to develop single payment rates for the office/outpatient E/M visit levels 2 through 5 (one rate for established patients, and one rate for new patients), in order to mitigate the need for physicians and other practitioners to adhere to complex payment-specific documentation rules for each and every visit furnished to a Medicare beneficiary. If there were minimal payment variation based on the level of visit billed, then there would be minimal need to engage with the burdensome and outdated documentation guidelines and E/M visit coding to justify that the appropriate level visit was reported. Though we acknowledged a continued need to document information in the medical record for clinical and other purposes, our understanding based on extensive feedback from medical professionals was that the documentation specific to justifying the visit level reported to payers, including Medicare, was unduly and disproportionately burdensome among the many administrative burdens in current medical practice. To avoid the administrative burden and disruption of establishing a new G code to describe the level 2 through 5 combined visit, under our proposal practitioners would continue to report on the claim the CPT code associated with the level of visit the practitioner believed they furnished.
Along with eliminating payment variation for office/outpatient E/M visit levels 2 through 5, we proposed a series of corollary policies intended to vary payment for these visits based on a more meaningful set of attributes for visits. Our goal was that these payment variations, accomplished through new add-on and other coding changes, and multiple procedure payment reductions, would reflect the relative resource costs of furnishing E/M visits without requiring detailed documentation for purposes of justifying particular payment rates. We also expected these adjustments to offset some of the more significant potentially redistributive impacts of this proposal, especially among physicians and practitioners of different specialties. The potential redistributive impacts helped us to determine potential, initial values for the proposed add-on codes providing for the adjustments. Again, these proposals were intended to provide a more meaningful avenue for payment variation that would ease the documentation burdens currently faced by clinicians to justify the visit level that is reported for each and every visit with a beneficiary. These proposals reflected our longstanding beliefs that: There are certain complexities inherent in furnishing some kinds of E/M visits that are not currently accounted for in valuations for the current E/M code set, there are unaccounted-for efficiencies when E/M visits are billed on the same day as global procedure codes that are already valued to include resources associated with E/M services, and the current E/M coding system does not fully account for the variety of legitimate circumstances when the needs of individual patients require more time with their physicians. We also proposed to establish unique E/M visit codes for podiatric care and make changes to the PE methodology in order to standardize the amount of PE RVUs allocated for this series of codes, regardless of which specialties were assumed to bill them.
In conjunction with our proposal to effectively eliminate the variation in payment of choosing from among E/M visit levels 2 through 5 for office/outpatient visits, we proposed a minimum level of associated documentation that would apply for payment purposes across all level 2 through 5 office/outpatient E/M visits. We also proposed to allow practitioners a choice regarding the basis for their documentation for these visits: Current documentation guidelines (history, exam and MDM); MDM alone; or time alone. We proposed that, when using current documentation guidelines or MDM, the current guidelines for level 2 visits would apply. When using time to document a visit, the practitioner would be required to demonstrate the medical necessity of the visit and report the total amount of face-to-face time they spent with the beneficiary. We solicited public comment on what the total time
We sought feedback in particular on the option to document using time when prolonged E/M services are billed. We proposed that when a practitioner uses time to document the visit and also reports prolonged E/M services, we would require the practitioner to document that the typical time required for the base or “companion” visit is exceeded by the amount required to report prolonged services (83 FR 35837). We did not propose any changes to CPT codes 99354 and 99355, and under our proposal these codes could still be billed, as needed, when their time thresholds and all other requirements are met (83 FR 35774).
Since we proposed to create a single payment rate under the PFS that would be paid for services billed using the current CPT codes for level 2 through 5 visits, it would not be material to Medicare's payment decision which CPT code (of levels 2 through 5) would be reported on the claim, except to justify billing a level 2 or higher visit in comparison to a level 1 visit (providing the visit itself was reasonable and necessary) and when using certain potential approaches to documenting the visit using time (83 FR 35836 through 35837). However, we expected that for record keeping purposes or to meet requirements of other payers, practitioners would continue to choose and report the level of E/M visit they believed to be appropriate under the current CPT coding structure.
We also proposed to remove an existing manual provision for home visits requiring documentation in the patient's medical record of the medical necessity of furnishing the visit in the home. For all office/outpatient E/M visits, we also proposed several simplifications centered on reducing the need for duplicative, redundant data entry in the medical record.
Several thousand commenters responded to this series of proposals. Generally, the commenters stated appreciation for CMS' goal of reducing administrative burden and reforming E/M coding and payment, but expressed concern about many impacts of the proposals. Commenters largely objected to our proposal to eliminate payment differences for office/outpatient E/M visit levels 2 through 5 based on the level of visit complexity. Many commenters stated that they would experience payment cuts relative to the current payment structure. Commenters generally stated that the implementation timeframe for the changes as proposed was too aggressive, especially since stakeholders were uncertain as to whether other payers would follow Medicare's proposed policies. Many commenters suggested that CMS could implement the proposed documentation reduction without the coding/payment policies, or that these policies could be adopted on separate timeframes.
Many commenters suggested that the proposals did not specify the circumstances in which the proposed add-on codes for office/outpatient E/M visits could be used, and what documentation requirements might be adopted for them. Many commenters stated that it would be better if the physician community could consider a range of alternative coding and payment options to be modeled and thoroughly evaluated over several years instead of a single alternative during a 60-day public comment period.
Many commenters opposed our proposal to establish that clinicians billing an office/outpatient E/M visit level 2 through 5 need only document medical necessity as specified for a level 2 visit (unless time is used as the basis for the visit level). Some commenters supported allowing a choice of documentation methodologies, while others opposed it. The vast majority of commenters did not support having only a single payment level to distinguish visit complexity (other than level 1), despite the associated minimum documentation that we proposed for these codes. Most commenters noted that CMS did not provide enough specificity in its proposals for how clinicians would document using time, and that because the definitions and billing rules regarding the add-on codes were ambiguous, they questioned whether the codes would have clinical validity. Regarding the valuation of these services, some commenters stated that the proposal did not follow the statutory requirement regarding using relative resources to set PFS rates. Others perceived that some of the newly proposed codes would be required or restricted based on physician specialty, and that such limitations would violate statutory provisions prohibiting varying payment for the same physicians' service by physician specialty.
Many commenters recommended that CMS finalize the documentation proposals regarding home visits and redundant data recording for 2019, but defer other documentation reforms to future years after stakeholders provide additional input. Some commenters recommended that CMS finalize the proposed choice among documentation methodologies while stakeholders work with CMS to refine what the coding and payment changes should be.
After considering the comments, for 2019 we are finalizing several of our documentation proposals that will provide some significant and immediate burden reduction, but are unrelated to changes to payment and coding. Specifically, we are finalizing the proposals regarding home visits and redundant data recording (discussed further in this section), as proposed, effective January 1, 2019.
After considering the comments, especially those suggesting that implementation of significant payment and coding changes requires time for practitioners, vendors, health systems, and other stakeholders to prepare, we are finalizing modified changes in payment coding, and associated documentation rules for E/M office/outpatient visits for 2021. These changes, detailed below, incorporate many significant changes from our proposals based on suggestions from the many comments we received. In brief summation, we are finalizing a significant reduction in the current payment variation in office/outpatient E/M visit levels by paying a single rate for E/M office/outpatient visit levels 2, 3, and 4 (one for established and another for new patients) beginning in 2021. However, we are not finalizing the inclusion of E/M office/outpatient level 5 visits in the single payment rate, to better account for the care and needs of particularly complex patients. Also, after consideration of public comments, we are not finalizing aspects of our proposal that would have: Reduced payment when E/M office/outpatient visits are furnished on the same day as procedures, established separate podiatric E/M visit codes, or standardized the allocation of PE RVUs for the codes that describe these services. We are finalizing a policy for 2021 to adopt add-on codes that describe the additional resources inherent in visits for primary care and particular kinds of specialized medical care. As discussed further below, these codes will only be reportable with E/M office/outpatient level 2 through 4 visits, and their use generally will not impose new per-visit documentation requirements. These codes are neither required nor restricted by physician specialty, though we acknowledge that,
For CY 2019 and 2020, we will continue the current coding and payment structure for E/M office/outpatient visits, and, therefore, practitioners should continue to use either the 1995 or 1997 versions of the E/M guidelines to document E/M office/outpatient visits billed to Medicare for 2019 and 2020 (with the exception of our final policy to eliminate redundant data recording).
Beginning in 2021, for E/M office/outpatient levels 2 through 5 visits, we will allow for flexibility in how visit levels are documented, specifically a choice to use the current framework, MDM or time. For E/M office/outpatient level 2 through 4 visits, beginning in 2021 we will also apply a minimum supporting documentation standard associated with level 2 visits when practitioners use the current framework or MDM to document the visit.
We intend to engage in further discussions with the public over the next several years to potentially further refine our policies, through future notice and comment rulemaking, for 2021. We discuss the public comments, our responses to the specific concerns and perspectives offered by commenters, and final policies in greater detail in this section.
Medicare pays for E/M visits furnished in the home (a private residence) under CPT codes 99341 through 99350. The payment rates for these codes are slightly more than for office visits (for example, approximately $30 more for a level 5 established patient, non-facility). The beneficiary need not be confined to the home to be eligible for such a visit. However, there is a Medicare Claims Processing Manual provision requiring that the medical record must document the medical necessity of the home visit made in lieu of an office or outpatient visit (Pub. 100-04, Medicare Claims Processing Manual, Chapter 12, Section 30.6.14.1.B., available on the CMS website at
The Medicare Claims Processing Manual states, “As for all other E/M services except where specifically noted, the Medicare Administrative Contractors (MACs) may not pay two E/M office visits billed by a physician (or physician of the same specialty from the same group practice) for the same beneficiary on the same day unless the physician documents that the visits were for unrelated problems in the office, off campus-outpatient hospital, or on campus-outpatient hospital setting which could not be provided during the same encounter” (Pub. 100-04, Medicare Claims Processing Manual, Chapter 12, Section 30.6.7.B., available on the CMS website at
This instruction was intended to reflect the idea that multiple visits with the same practitioner, or by practitioners in the same or very similar specialties within a group practice, on the same day as another E/M service would not be medically necessary. However, stakeholders have provided a few examples where this policy does not make sense with respect to the current practice of medicine as the Medicare enrollment specialty does not always coincide with all areas of medical expertise possessed by a practitioner—for example, a practitioner with the Medicare enrollment specialty of geriatrics may also be an endocrinologist. If such a practitioner was one of many geriatricians in the same group practice, they would not be able to bill separately for an E/M visit focused on a patient's endocrinological issue if that patient had another more generalized E/M visit by another geriatrician on the same day. Stakeholders have pointed out that in these circumstances, practitioners often respond to this instruction by scheduling the E/M visits on two separate days, which could unnecessarily inconvenience the patient. Given that the number and granularity of practitioner specialties recognized for purposes of Medicare enrollment continue to increase over time (consistent with the medical community's requests), the value to the Medicare program of the prohibition on same-day E/M visits billed by physicians in the same group and medical specialty may be diminishing, especially as we believe it is becoming more common for practitioners to have multiple specialty affiliations, but would have only one primary Medicare enrollment specialty. We believe that eliminating this policy may better recognize the changing practice of medicine while reducing administrative burden. The impact of this proposal on program expenditures and beneficiary cost sharing is unclear. To the extent that many of these services are currently merely scheduled and furnished on different days in response to the instruction, eliminating this manual provision may not significantly increase utilization, Medicare spending and beneficiary cost sharing.
We solicited public comment on whether we should eliminate the manual provision given the changes in the practice of medicine or whether there is concern that eliminating it might have unintended consequences for practitioners and beneficiaries.
We recognize that this instruction may be appropriate only in certain clinical situations, so we also solicited public comments on whether and how we should consider creating exceptions to, or modify this manual provision rather than eliminating it entirely. We also requested that the public provide additional examples and situations in
Informed by comments and examples that we have received stating that the current E/M documentation guidelines are outdated with respect to the current practice of medicine, and in our efforts to simplify documentation for the purposes of coding E/M visit levels, we proposed to allow practitioners to choose, as an alternative to the current framework specified under the 1995 or 1997 guidelines, either MDM or time as a basis to determine the appropriate level of E/M visit. This would allow different practitioners in different specialties to choose to document the factor(s) that matter most given the nature of their clinical practice. It would also reduce the impact Medicare may have on the standardized recording of history, exam and MDM data in medical records, since practitioners could choose to no longer document many aspects of an E/M visit that they currently document under the 1995 or 1997 guidelines for history, physical exam and MDM. Although we initially considered reducing the number of key components that practitioners needed to document in choosing the appropriate level of E/M service to bill, feedback from the stakeholder community led us to believe that offering practitioners a choice to either retain the current framework or choose among new options that involve a reduced level of documentation would be less burdensome for practitioners, and would allow more stability for practitioners who may need time to prepare for any potential new documentation framework.
We sought to be clear that as part of this proposal, practitioners could use MDM, or time, or they could continue to use the current framework to document an E/M visit. In other words, we would be offering the practitioner the choice to continue to use the current framework by applying the 1995 or 1997 documentation guidelines for all three key components. However, our proposals on payment for office-based/outpatient E/M visits described later in this section would apply to all practitioners, regardless of their selected documentation approach. Under our proposal, all practitioners, even those choosing to retain the current documentation framework, would be paid at the proposed new payment rate described in the CY 2019 PFS proposed rule (one rate for new patients and another for established patients), and could also report applicable G-codes as we proposed (83 FR 35839 through 35843).
We also sought to be clear that we proposed to retain the current CPT coding structure for E/M visits (along with our proposal to create new replacement codes for podiatry office/outpatient E/M visits). Practitioners would report on the professional claim whatever level of visit (1 through 5) they believe they furnished using CPT codes 99201-99215. Because we believed the adoption of replacement G-codes to describe the visit levels 2 through 5 might result in unnecessary disruption to current billing systems and practices, we did not propose to modify the existing CPT coding structure for E/M visits. Since we proposed to create a single rate under the PFS that would be paid for services billed using the current CPT codes for level 2 through 5 E/M visits, under our proposal, it would not have been material to Medicare's payment decision which CPT code (of levels 2 through 5) is reported on the claim, except to justify billing a level 2 or higher visit in comparison to a level 1 visit (provided the visit itself was reasonable and necessary). We stated that we expected that, for record keeping purposes or to meet requirements of other payers, many practitioners would continue to choose and report the level of E/M visit they believed to be appropriate under the CPT coding structure.
Even though under our proposal, there would have been no payment differential for E/M visits based on which of the codes describing visit levels 2 through 5 were reported, we believed we would still need to simplify and change our documentation requirements to better align with the current practice of medicine and eliminate unnecessary aspects of the current documentation framework. As a corollary to our proposal to adopt a single payment amount for office/outpatient E/M visit levels 2 through 5 (83 FR 35839 through 35843), we proposed to apply a minimum documentation standard where, for the purposes of PFS payment for an office/outpatient E/M visit, practitioners would only need to meet documentation requirements currently associated with a level 2 visit for history, exam and/or MDM, except when using time to document the service. Practitioners could choose to document more information for clinical, legal, operational or other purposes, and we anticipated that for those reasons, practitioners would continue generally to seek to document medical record information that is consistent with the level of care furnished. For purposes of our medical review, however, for practitioners using the current documentation framework or, as we proposed, MDM, Medicare would only require documentation to support the medical necessity of the visit and the documentation that is associated with the current level 2 CPT visit code.
For example, for a practitioner choosing to document using the current framework (1995 or 1997 guidelines), our proposed minimum documentation for any billed level of E/M visit from levels 2 through 5 could include: (1) A problem-focused history that does not include a review of systems or a past, family, or social history; (2) a limited examination of the affected body area or organ system; and (3) straightforward medical decision making measured by minimal problems, data review, and risk (two of these three). If the practitioner was choosing to document based on MDM alone, Medicare would only require documentation supporting straightforward medical decision-making measured by minimal problems, data review, and risk (two of these three).
Some commenters had suggested that the current framework of guidelines for the MDM component of visits would need to be changed before MDM could be relied upon by itself to distinguish visit levels. We proposed to allow practitioners to rely on MDM in its current form to document their visit, and solicited public comment on whether and how guidelines for MDM might be changed in subsequent years.
As described earlier, we currently allow time or duration of visit to be used as the governing factor in selecting the appropriate E/M visit level only when counseling and/or coordination of care accounts for more than 50 percent of the face-to-face physician/patient encounter (or, in the case of inpatient E/M services, the floor time). Our proposal to allow practitioners the choice of using time to document office/outpatient E/M visits would have meant that this time-based standard is not limited to E/M visits in which counseling and/or care coordination
Some commenters had raised concerns with reliance on time to distinguish visit levels, for example the potential for abuse, inequities among more- or less-efficient practitioners, and specialties for which time is less of a factor in determining visit complexity. We noted in the proposed rule that relying on time as the basis for identifying the E/M visit level would also raise the issue of what would be required by way of supporting documentation; for example, what amount of time should be documented, and whether the specific activities comprising the time need to be documented and to what degree. However, a number of stakeholders had suggested that, within their specialties, time is a good indicator of the complexity of the visit or patient, and requested that we allow practitioners to use time as the single factor in all E/M visits, not just when counseling or care coordination dominate a visit. We agreed that for some practitioners and patients, time may be a good indicator of complexity of the visit, and proposed to allow practitioners the option to use time as the single factor in selecting visit level and documenting the E/M visit, regardless of whether counseling or care coordination dominate the visit. We stated that if finalized, we would monitor the results of this policy for any program integrity issues, administrative burden or other issues.
For practitioners choosing to support their coding and payment for an E/M visit by documenting the amount of time spent with the patient, we proposed to require the practitioner to document the medical necessity of the visit and show the total amount of time spent by the billing practitioner face-to-face with the patient. We solicited public comment on what that total time should be for payment of the single, new rate for E/M visits levels 2 through 5. We presented the typical time for our proposed new single payment for E/M visit levels 2 through 5 (the weighted average of the intra-service times across the current E/M visit utilization) and suggested we could use this time. We noted that currently the PFS does not require the practitioner to spend or document a specified amount of time with a given patient in order to receive payment for an E/M visit, unless the visit is dominated by counseling/care coordination and, on that account, the practitioner is using time as the basis for code selection. The times for E/M visits and most other PFS services in the physician time files, which are used to set PFS rates, are typical times rather than requirements, and were recommended by the AMA RUC and then reviewed and either adopted or adjusted for Medicare through our usual ratesetting process as “typical,” but not strictly required.
We presented a potential alternative to apply the AMA's CPT codebook provision that, for timed services, a unit of time is attained when the mid-point is passed,
We presented another potential alternative to require documentation that the typical time for the CPT code that is reported (which is also the typical time listed in the AMA's CPT codebook for that code) was spent face-to-face by the billing practitioner with the patient. For example, a practitioner reporting CPT code 99212 (a level 2 established patient visit) would be required to document having spent a minimum of 10 minutes, and a practitioner reporting CPT code 99214 (a level 4 established patient visit) would be required to document having spent a minimum of 25 minutes. Under this approach, the total amount of time spent by the billing practitioner face-to-face with the patient would inform the level of E/M visit (of levels 2 through 5) coded by the billing practitioner. We noted that in contrast to other proposed documentation approaches discussed above, this approach of requiring documentation of the typical time associated with the CPT visit code reported on the claim would introduce unique payment implications for reporting that code, especially when the time associated with the billed E/M code is the basis for reporting prolonged E/M services.
We solicited public comments on the use of time as a framework for documentation of office/outpatient E/M visits, and whether we should adopt any of these approaches or specify other requirements with respect to the proposed option for documentation using time.
In providing us with feedback, we requested that commenters take into consideration ways in which the time associated with, or required for, the billing of any add-on codes (especially the proposed prolonged E/M visit add-on code(s) described in the CY 2019 PFS proposed rule (83 FR 35844)) would intersect with the time spent for the base E/M visit, when the practitioner is documenting the E/M visit using only time. Currently, when reporting prolonged E/M services, we expect the practitioner to exceed the typical time assigned for the base E/M visit code (also commonly referred to as the companion code). For example, in the CY 2017 PFS final rule (81 FR 80229), we expressed appreciation for the commenters' suggestion to display the typical times associated with relevant services. We also discussed, and in response to those comments, decided to post a file annually that notes the times assumed to be typical for purposes of PFS ratesetting for practitioners to use as a reference in deciding whether time requirements for reporting prolonged E/M services are met. We stated that although these typical times are not required for a practitioner to bill the displayed base codes, we expect that only time spent in excess of these times will be reported using a non-face-to-face prolonged service code. We proposed to formalize this policy in the case where a practitioner uses time to document a visit, since there would be a stricter time requirement associated with the base E/M code. Specifically, we proposed that, when a practitioner chooses to document using time and also reports prolonged E/M services, we would require the practitioner to document that the typical time required for the base or “companion” visit is exceeded by the amount required to report prolonged services. Further discussion of our proposal regarding reporting prolonged E/M services is available in the CY 2019 PFS proposed rule (83 FR 35844).
We believed that allowing practitioners to choose the most appropriate basis for distinguishing among the levels of E/M visits and applying a minimum documentation requirement, together with reducing the payment variation among E/M visit levels, would significantly reduce administrative burden for practitioners, and would avoid the current need to make coding and documentation decisions based on codes and documentation guidelines that are not a good fit with current medical practice. The practitioner could choose to use
We solicited public comment on these proposals to provide practitioners choice in the basis for documenting E/M visits in an effort to allow for documentation alternatives that better reflect the current practice of medicine and to alleviate documentation burden. We stated our interest in receiving public comments on practitioners' ability to avail themselves of these choices for how they would impact clinical workflows, EHR templates, and other aspects of practitioner work.
Stakeholders had requested that CMS not merely shift burden by implementing another framework that might avoid issues caused by the current guidelines, but that would be equally complex and burdensome. Our primary goal was to reduce administrative burden so that the practitioner can focus on the patient, and we were interested in commenters' opinions as to whether our E/M visit proposals would, in fact, support and further this goal. We believed our proposals would allow practitioners to exercise greater clinical judgment and discretion in what they document, focusing on what is clinically relevant and medically necessary for the patient rather than what will illustrate that the appropriate visit level was reported. Although we proposed to no longer apply much of the E/M documentation guidelines involving history, physical exam and, for those choosing to document based on time, documentation of medical decision-making, we stated our expectation that practitioners would continue to perform as medically necessary for the patient and document E/M visits to ensure quality and continuity of care. For example, we believed that it remains an important part of care for the practitioner to understand the patient's social history, even though certain documentation options we proposed would no longer require that history to be re-documented to bill Medicare for the visit.
Many of the commenters did not support the proposal, as a corollary to our proposal to adopt a single payment amount for office-outpatient E/M visit levels 2 through 5, to apply a minimum level 2 documentation standard. These commenters were concerned that this standard would result in inadequate documentation for patient care, legal and other purposes. They noted that CMS overestimated the associated reduction in burden that would result from this proposal, and instead believe the level 2 documentation standard would reduce burden to a lesser degree than we estimated, or potentially increase burden. They indicated that there would be costs in terms of time and resources to update EHRs and train staff, and that they expected there would be the need to continue documenting many elements included in the current code definitions for patient care and other purposes, including other payers. Many commenters expressed concern that the documentation could potentially increase due to misalignment in documentation rules between payers, as they presume that Medicaid, commercial payers and secondary payers would not likely adopt Medicare's payment changes, at least not immediately. Several commercial payers or their associations expressed similar concerns and recommended implementing a more limited set of documentation changes and ongoing monitoring.
MedPAC and a few other commenters recommended paying for visits on the basis of time alone. MedPAC recommended requiring the time spent to be reported on the claim so CMS can collect data on current times actually spent and use it to more accurately set rates in the future.
A few commenters indicated what the time requirement should be when using time to document. Most of these commenters noted that CMS should require the typical time associated with the CPT code reported on the claim. One commenter who opposed the single payment rate stated that if CMS did finalize a single payment rate, then CMS should require only the time associated with the level 2 CPT codes (10 minutes for an established patient and 20 minutes for a new patient). Some commenters expressed support for requiring that this time be spent by the billing practitioner face-to-face with the patient, and a few commenters expressed support for allowing time spent by individuals other than the billing practitioner and/or time spent furnishing non-face-to-face care to count.
We appreciate the issues raised by commenters but continue to believe our proposals allowing for flexibility in how E/M office/outpatient visit levels are documented and the applying of a minimum documentation standard as a corollary to establishing single payment rates for E/M office/outpatient visits will significantly reduce burden for clinicians and support them in making coding and documentation decisions that better align with current medical practice. Beginning in 2021, for E/M office/outpatient levels 2 through 5 visits, we will allow for flexibility in how visit levels are documented, allowing billing practitioners the choice to use the current framework, MDM or time. Specifically, for level 5 visits, for PFS payment purposes a practitioner can use the current framework with the documentation requirements applicable to a level 5 visit or the current definition of level 5 MDM. As an another alternative, the practitioner can document using time, which will require documentation of the medical necessity of the visit and that the billing practitioner personally spent at least the typical time associated with the level 5 CPT code that is reported face-to-face with the patient (40 minutes for an established patient and 60 minutes for a new patient). Since there will be no new intra-service time associated with the level 5 visit codes, we are finalizing our proposed alternative to use the typical time associated with the CPT code reported on the claim, consistent with current policy when counseling and/or coordination of care accounts for more than 50 percent of the face-to-face physician/patient encounter.
For E/M office/outpatient level 2 through 4 visits, in 2021 we will also allow choice of documentation methodology (current framework, MDM or time). For practitioners using the current documentation framework or
We address the public comments on our burden reduction estimate and changes to our estimate based on our final policies further below (see section VII. of this final rule, Regulatory Impact Analysis). We intend to engage in further discussions with the public over the next several years to potentially further refine our policies for 2021.
As we noted in the CY 2019 PFS proposed rule, we heard from a few commenters on the CY 2018 PFS proposed rule that some practitioners rely on unofficial Marshfield clinic or other criteria to help them document E/M visit levels. These commenters conveyed that the Marshfield “point system” is commonly used to supplement the E/M documentation guidelines, because of a lack of concrete criteria for certain elements of medical decision making in the 1995 and 1997 guidelines or in CPT guidance. Accordingly, in the CY 2019 PFS proposed rule, we solicited public comment on whether Medicare should use or adopt any aspects of other E/M documentation systems that may be in use among practitioners, such as the Marshfield tool. We were interested in feedback as to whether the 1995 and 1997 guidelines contain adequate information for practitioners to use in documenting visits under our proposals, or whether these versions of the guidelines would need to be supplemented in any way.
The following is a summary of the comments we received on whether Medicare should use or adopt any aspects of other E/M documentation systems that may be in use among practitioners, such as the Marshfield tool, and also whether the 1995 and 1997 guidelines contain adequate information for practitioners to use in documenting visits under our proposals, or whether these versions of the guidelines would need to be supplemented in any way.
Stakeholders have recently expressed that CMS should not require documentation of information in the billing practitioner's note that is already present in the medical record, particularly with regard to history and exam. Currently, both the 1995 and 1997 guidelines provide such flexibility for certain parts of the history for established patients, stating, “A Review of Systems “ROS” and/or a pertinent past, family, and/or social history (PFSH) obtained during an earlier encounter does not need to be re-recorded if there is evidence that the physician reviewed and updated the previous information. This may occur when a physician updates his/her own record or in an institutional setting or group practice where many physicians use a common record. The review and update may be documented by:
• Describing any new ROS and/or PFSH information or noting there has been no change in the information; and
• Noting the date and location of the earlier ROS and/or PFSH.
We proposed to expand this policy to further simplify the documentation of history and exam for established patients such that, for both of these key components, when relevant information is already contained in the medical record, practitioners would only be required to focus their documentation on what has changed since the last visit or on pertinent items that have not changed, rather than re-documenting a defined list of required elements such as review of a specified number of systems and family/social history. Practitioners would still review prior data, update as necessary, and indicate in the medical record that they had done so. Practitioners would conduct clinically relevant and medically necessary elements of history and physical exam, and conform to the general principles of medical record documentation in the 1995 and 1997 guidelines. However,
We solicited comment on whether there may be ways to implement a similar provision for any aspects of medical decision-making, or for new patients, such as when prior data is available to the billing practitioner through an interoperable EHR or other data exchange. We stated our belief that there would be special challenges in realizing documentation efficiencies with new patients, since they may not have received exams or histories that were complete or relevant to the current complaint(s), and the information in the transferred record could be more likely to be incomplete, outdated or inaccurate.
We similarly proposed that for both new and established patients, practitioners would no longer be required to re-enter information in the medical record regarding the chief complaint and history that are already entered by ancillary staff or the beneficiary. The practitioner could simply indicate in the medical record that they reviewed and verified this information. Our goal was to allow practitioners more flexibility to exercise greater clinical judgment and discretion in what they document, focusing on what is clinically relevant and medically necessary for the patient.
As described in the CY 2019 PFS proposed rule (83 FR 35843), as part of our proposal to improve payment accuracy by creating a single PFS payment rate for E/M visit levels 2 through 5 (with one proposed rate for new patients and one proposed rate for established patients), we proposed to create separate coding for podiatry visits that are currently reported as E/M office/outpatient visits. We proposed that, rather than reporting visits under the general E/M office/outpatient visit code set, podiatrists would instead report visits under new G-codes that more specifically identify and value their services. We proposed to apply substantially the same documentation standards for these proposed new podiatry-specific codes as we proposed for other office/outpatient E/M visits.
If a practitioner chose to use time to document a podiatry office/outpatient E/M visit, we proposed to apply substantially the same rules as those we proposed for documenting on the basis of time for other office/outpatient E/M visits. For practitioners choosing to use time to provide supporting documentation for the podiatry visit, we would require documentation supporting the medical necessity of the visit and showing the total amount of time spent by the billing practitioner face-to-face with the patient. We solicited public comment on what that total time would be for payment of the proposed new podiatry G-codes. The typical times for these proposed codes were 22 minutes for an established patient and 28 minutes for a new patient, and we noted we could use these times. Alternatively, we noted we could apply the AMA's CPT codebook provision that, for timed services, a unit of time is attained when the mid-point is passed,
As we have explained above, and in prior rulemaking, we believe that the coding, payment, and documentation requirements for E/M visits are overly burdensome and no longer aligned with the current practice of medicine. We believe the current set of 10 CPT codes for new and established office-based and outpatient E/M visits and their respective payment rates no longer appropriately reflect the complete range of services and resource costs associated with furnishing E/M services to all patients across the different physician specialties, and that documenting these services using the current guidelines has become burdensome and out of step with the current practice of medicine. To alleviate the effects and mitigate the burden associated with continued use of the outdated CPT code set, we proposed to simplify the office-based and outpatient E/M payment rates and documentation requirements, and create new add-on codes to better capture the differential resources involved in furnishing certain types of E/M visits.
In conjunction with our proposal to reduce the documentation requirements for E/M visit levels 2 through 5, we proposed to simplify the payment for those services by paying a single rate for the level 2 through 5 E/M visits. The visit level of the E/M service is tied to the documentation requirements in the 1995 and 1997 Documentation Guidelines for E/M Services, which may not be reflective of changes in technology or, in particular, the ways that electronic medical records have changed documentation and the patient's medical record. Additionally, current documentation requirements may not account for changes in care delivery, such as a growing emphasis on team based care, increases in the number of recognized chronic conditions, or increased emphasis on access to behavioral health care. However, based on the feedback we have received from stakeholders, it was clear to us that the burdens associated with documenting the selection of the level of E/M service arise from not only the documentation guidelines, but also from the coding structure itself. Like the documentation guidelines, the distinctions between visit levels reflect a reasonable assessment of variations in care, effort, and resource costs as identified and articulated several decades ago. We believed that the most important distinctions between the kinds of visits furnished to Medicare beneficiaries are not well reflected by the current E/M visit coding. Most significantly, we have understood from stakeholders that current E/M coding does not reflect important distinctions in services and differences in resources. At present, we believed the current payment for E/M visit levels, generally distinguished by common elements of patient history, physical exam, and MDM, that may have been good approximations for important distinctions in resource costs between kinds of visits in the 1990s, when the CPT developed the E/M code set, are increasingly outdated in the context of changing models of care and information technologies.
As described earlier in this section, we proposed to change the documentation requirements for E/M levels such that practitioners have the choice to use the 1995 guidelines, 1997 guidelines, time, or MDM to determine the E/M level. We believed that these proposed changes would better reflect the current practice of medicine and represent significant reductions in burdens associated with documenting visits using the current set of E/M codes.
In alignment with our proposed documentation changes, we proposed to develop a single set of RVUs under the PFS for E/M office-based and outpatient visit levels 2 through 5 for new patients (CPT codes 99202 through 99205) and a single set of RVUs for visit levels 2 through 5 for established patients (CPT codes 99212 through 99215). Although we considered creating new HCPCS G-codes that would describe the services associated with these proposed payment rates, given the wide and longstanding use of these visit codes by both Medicare and private payers, we believed it would have created unnecessary administrative burden to propose new coding. Therefore, we instead proposed to maintain the current code set. Of the five levels of office-based and outpatient E/M visits, the vast majority of visits are reported as levels 3 and 4. In CY 2016, CPT codes 99203 and 99204 (or E/M visit level 3 and level 4 for new patients) made up around 32 percent and 44 percent, respectively, of the total allowed charges for CPT codes 99201-99205. In the same year, CPT codes 99213 and 99214 (or E/M visit level 3 and 4 for established patients) made up around 39 percent and 50 percent, respectively, of the allowed charges for CPT codes 99211-99215. If our proposals to simplify the documentation requirements and to pay a single PFS rate for new patient E/M visit levels 2 through 5 and a single rate for established patient E/M visit levels 2 through 5 were finalized, practitioners would still bill the CPT code for whichever level of E/M service they furnished and they would be paid at the single PFS rate. However, we believed that eliminating the distinction in payment between visit levels 2 through 5 would eliminate the need to audit against the visit levels, and therefore, would provide immediate relief from the burden of documentation. A single payment rate would also eliminate the increasingly outdated distinction between the kinds of visits that are reflected in the current CPT code levels in both the coding and the associated documentation rules.
In order to set RVUs for the proposed single payment rate for new and established patient office/outpatient E/M visit codes, we proposed to develop resource inputs based on the current inputs for the individual E/M codes, generally weighted by the frequency at which they are currently billed, based on the 5 most recent years of Medicare claims data (CY 2012 through CY 2017). Specifically, we proposed a work RVU of 1.90 for CPT codes 99202 through 99205, a physician time of 37.79 minutes, and direct PE inputs that sum to $24.98, each based on an average of the current inputs for the individual codes weighted by 5 years of accumulated utilization data. Similarly, we proposed a work RVU of 1.22 for CPT codes 99212 through 99215, with a physician time of 31.31 minutes and direct PE inputs that sum to $20.70. These inputs were based on an average of the inputs for the individual codes, weighted by volume based on utilization data from the past 5 years (CY 2012 through CY 2017). Tables 19 and 20 reflect the payment rates in dollars that would result from the approach described above were it to have been implemented for CY 2018. In other words, the dollar amounts in the charts below reflect how the changes we proposed for CY 2019 would have impacted payment rates for CY 2018.
Although we believed that the proposed rates for E/M visit levels 2 through 5 represent the valuation of a typical E/M service, we also recognized that the current E/M code set itself does not appropriately reflect differences in resource costs between certain types of E/M visits. As a result, we believed that the way we currently value the resource costs for E/M services through the existing HCPCS CPT code set for office-based and outpatient E/M visits does not appropriately reflect the resources used in furnishing the range of E/M services that are provided through the current the practice of medicine. Based on stakeholder comments and examples and our review of the literature on E/M services, we identified three types of E/M visits that differ from the typical E/M visit and are not appropriately reflected in the current office/outpatient E/M code set and valuation. Rather, these three types of E/M visits can be distinguished by the mode of care provided and, as a result, have different resource costs. The three types of E/M visits that differ from the typical E/M service are (1) separately identifiable E/M visits furnished in conjunction with a global procedure, (2) primary care E/M visits for continuous patient care, and (3) certain types of specialist E/M visits, including those with inherent visit complexity. We addressed each of these distinguishable visit types in the proposed rule.
The following is a summary of the comments we received on the proposed blended payment rate for new and established office/outpatient E/M visit levels 2 through 5.
The few commenters who supported the proposal stated that the negative payment implications of the single proposed payment rate are outweighed by the reduction in documentation burden. While acknowledging that the initial years following adoption of a single payment rate for the level 2 through 5 E/M visit codes would be challenging, these commenters noted that over time, potential reductions in payment would be offset by the time saved from unnecessary documentation. Other commenters, while urging CMS not to finalize the proposed single payment rate for these codes, did provide suggested alternative coding structures. Of these comments, there was a consensus that three levels of coding for office and outpatient E/M services is preferable to two, whether that be accomplished through blended payment rates for levels 2 through 3 and 4 through 5, or through a blended rate for levels 2 through 4. Most commenters pointed to the joint CPT/AMA E/M workgroup formed in response to CMS' proposal, and urged CMS to wait for forthcoming coding and documentation definitions generated by that group and recommendations regarding valuation developed through the RUC process.
We do not believe, however, that appropriate care for complex patients currently requiring visit levels 2 through 4 are nearly as dependent on the current payment variations for these services. Given that the significant majority of the volume is concentrated in the level 3 and 4 new and established patient visits, we believe the concerns expressed by commenters about potential shifts in practitioner behavior would be likely to occur. We believe it would simply not be practical for clinicians to prioritize seeing the relatively few potential patients requiring level 2 visits in order to maximize their revenue relative to per patient costs. Likewise, because the level 4 established patient E/M visit is the most commonly reported code among the 5 levels for both new and established patients, any effort to avoid treating patients requiring care that is currently reported as a level 4 visit would likely result in significantly reduced volume and overall revenue for physician practices. We will, however, monitor utilization of these services and make any necessary adjustments through future rulemaking. Additionally, we recognize that because level 5 visits represent a very small proportion of visits reported under current E/M coding, maintaining
On that basis, we are finalizing for 2021, a single payment rate for levels 2 through 4 E/M office/outpatient visits (one rate for new, and one for established patients) and maintaining separate payment rates for new and established patients for level 5 E/M office/outpatient visits to account for the most complex patients and visits. We are finalizing a policy, modified from our proposal, to develop a set of single payment rates for visit levels 2 through 4 (one each for new and established patients), instead of levels 2 through 5, as proposed. We are finalizing development of payment rates for levels 2 through 4 visits using the weighted average of the current inputs (work RVUs, direct PE inputs, time and specialty mix) assigned to the individual codes, based on the most recent 5 years of utilization for each of the constituent codes. For the level 1 and level 5 office/outpatient E/M visits we are finalizing payment rates that rely on current inputs. The inputs we will use (in the absence of intervening changes to CPT coding or the development of other considerations) to develop proposed values for these services for 2021 appear in the Table 21.
We are also finalizing separate, add-on payments for visit complexity inherently associated with primary care and non-procedural specialty care, as well as separate payment for extended visits via HCPCS G-codes. These codes and the associated policies will be discussed in greater detail in the discussion below. We recognize that many commenters, including the AMA, the RUC, and specialties that participate as members in those committees, have stated intentions of the AMA and the CPT Editorial Panel to revisit coding for E/M office/outpatient services in the immediate future. We note that the 2-year delay in implementation will provide the opportunity for us to respond to the work done by the AMA and the CPT Editorial Panel, as well as other stakeholders. We will consider any changes that are made to CPT coding for E/M services, and recommendations regarding appropriate valuation of new or revised codes, through our annual rulemaking process.
As a corollary to our proposal to adopt a single payment rate for office and outpatient E/M services for level 2 through 5 E/M visits, we stated that we could better capture differential resource costs and minimize reporting and documentation burden by proposing several additional payment policies and ratesetting adjustments. These additional proposals were intended to reflect the important distinctions between the kinds of visits furnished to Medicare beneficiaries, and to reduce the burden of billing and documentation rules to effectuate payment.
In response to the CY 2018 comment solicitation on burden reduction for E/M visits (82 FR 53163 through 53166), we received several comments that highlighted the inadequacy of the E/M code set to accurately pay for the resources associated with furnishing visits, particularly for primary care visits, and visits associated with treating patients with particular conditions for which there is not additional procedural coding. One commenter stated that the current structure and valuation of the E/M code set inadequately describes the range of services provided by different specialties, and in particular primary care services. This commenter noted that although the 10 office/outpatient E/M codes make up the bulk of the services reported by primary care practitioners, the valuation does not reflect their particular resource costs. Another commenter pointed out that for specialties that principally rely on E/M visit codes to bill for their professional services, the complex medical decision making and the intensity of their visits is not reflected in the E/M code set or documentation guidelines.
In view of the comments we received, we proposed the following adjustments to better capture the variety of resource costs associated with different types of care provided in E/M visits: (1) An E/M multiple procedure payment adjustment to account for duplicative resource costs when E/M visits and procedures with global periods are furnished together; (2) HCPCS G-code add-ons to recognize additional relative resources for primary care visits and inherent visit complexity that require additional work beyond that which is accounted for in the single payment rates for new and established patient levels 2 through level 5 visits; (3) HCPCS G-codes to describe podiatric E/M visits; (4) an additional prolonged face-to-face services add-on HCPCS G-code; and (5) a technical modification to the PE methodology to stabilize the allocation of indirect PE for visit services.
Under the PFS, E/M services are generally paid in one of two ways: As standalone visits using E/M visit codes, or included in global procedural codes. In both cases, RVUs are allocated to the services to account for the estimated relative resources involved in furnishing professional E/M services. In the case of procedural codes with global periods,
In cases where a physician furnishes a separately identifiable E/M visit to a beneficiary on the same day as a procedure, payment for the procedure and the E/M visit is based on rates generally developed under the assumption that these services are typically furnished independently. In CY 2017 PFS rulemaking, we noted that the current valuation for services with global periods may not accurately reflect much of the overlap in resource costs (81 FR 80209). We were particularly concerned that when a standalone E/M visit occurs on the same day as a 0-day global procedure, there are significant overlapping resource costs that are not accounted for. We believe that separately identifiable visits occurring on the same day as 0-day global procedures have resources that are sufficiently distinct from the costs associated with furnishing one of the 10 office/outpatient E/M visits to warrant payment adjustment. There are other existing policies under the PFS where we reduce payments if multiple procedures are furnished on the same day to the same patient. Medicare has a longstanding policy to reduce payment by 50 percent for the second and subsequent surgical procedures furnished to the same patient by the same physician on the same day, largely based on the presence of efficiencies in PE and pre- and post-surgical physician work. Effective January 1, 1995, the MPPR policy, with the same percentage reduction, was extended to nuclear medicine diagnostic procedures (CPT codes 78306, 78320, 78802, 78803, 78806, and 78807). In the CY 1995 PFS final rule with comment period (59 FR 63410), we indicated that we would consider applying the policy to other diagnostic tests in the future. In the CYs 2009 and 2010 PFS proposed rules (73 FR 38586 and 74 FR 33554, respectively), we stated that we planned to analyze nonsurgical services commonly furnished together (for example, 60 to 75 percent of the time) to assess whether an expansion of the MPPR policy could be warranted. MedPAC encouraged us to consider duplicative physician work, as well as PE, in any expansion of the MPPR policy. Finally, in the CY 2011 PFS final rule with comment period, CMS finalized the application of the MPPR to always-therapy services on the justification that there was significant overlap in the PE portion of these services (75 FR 73233).
Using the surgical MPPR as a template, we proposed that, as part of our proposal to make payment for the E/M levels 2 through 5 at a single PFS rate, we would reduce payment by 50 percent for the least expensive global procedure or visit that the same physician (or a physician in the same group practice) furnishes on the same day as a separately identifiable E/M visit, currently identified on the claim by an appended modifier -25. We believed that the efficiencies associated with furnishing an E/M visit in combination with a same-day global procedure were similar enough to those accounted for by the surgical MPPR to merit a reduction in the relative resources of 50 percent. We estimated that, based on CY 2017 Medicare claims data, applying a 50 percent MPPR to E/M visits furnished as separately identifiable services on the same day as a global procedure would reduce expenditures under the PFS by approximately 6.7 million RVUs. To accurately reflect resource costs of the different types of E/M visits that we previously identified while maintaining work budget neutrality within this proposal, we proposed to allocate those RVUs toward the values of the add-on codes that reflect the additional resources associated with E/M visits for primary care and inherent visit complexity, similar to existing policies. As we articulated in the CY 2012 PFS final rule with comment period, where the aggregate work RVUs within a code family change but the overall actual physician work associated with those services does not change, we make work budget neutrality adjustments to hold the aggregate work RVUs constant within the code family, while maintaining the relativity of values for the individual codes within that set (76 FR 73105).
Many commenters, including both physician specialty organizations and patient advocacy groups, expressed concerns about how physicians would respond to the financial incentives resulting from the application of an MPPR adjustment in the context of patient care. Commenters noted that it is often convenient for both the beneficiary and the practitioner to address multiple concerns in a single visit. Many commenters stated that there would be a strong financial incentive to bring patients back for necessary visits on a different day so as to avoid triggering the payment reduction. This would result in inconvenience to the beneficiary, as they would experience treatment delays and be forced to return for a visit. Some commenters suggested this approach would result in additional cost sharing for patients.
Several commenters also highlighted programmatic concerns, stating that an MPPR adjustment would incentivize fractured care and undermine the goals of patient-centered and value-based care. Commenters also requested that CMS clarify whether certain other visits, such as the annual wellness visit, would also be subject to the MPPR adjustment. Others stated that inconsistent guidance, differing policies, and varying edits among the MACs would result in confusion and administrative burden in the implementation of this proposal.
A few commenters, including MedPAC, supported the proposal. MedPAC stated that when a standalone E/M visit occurs on the same day as a procedure, there are efficiencies (for example, in pre-service and post-service clinician work and practice expense) that are not accounted for in the current payment system. MedPAC concluded
We continue to have significant concerns about the appropriate payment when codes with global periods, especially 0 and 10-day global periods, are billed on the same day as an E/M visit. Generally, we understand that the global codes are valued to include the typical amount of evaluation and management furnished to patients as part of the service. We understand that when these codes are reported, the -25 modifier is used with an E/M code to report a significant, separately identifiable E/M visit that is furnished on the same day. We also note that the CPT descriptor of the -25 modifier includes language suggesting that the modifier can be used whenever care beyond the usual preoperative and postoperative care associated with the procedure is performed. We note further that the values for global codes are intended to incorporate the typical amount of pre- and post-operative care. However, given the CPT description of the -25 modifier, a separately reportable visit could be billed in any case where the pre- or post-operative care exceeds the typical amount. In contrast, there does not appear to be a way to similarly account for cases where the needs of a particular patient require less than the typical amount of preoperative and postoperative work.
Although many commenters suggested that the overlapping resource costs between global codes and E/M visits billed on the same day have already been accounted for, we are not persuaded by the statements that the RUC process has achieved this goal, and we agree with MedPAC's assessment of the significant problem with valuation of codes that describe global services. We acknowledge and appreciate the efforts of the RUC to address overlaps when they recognize that a code is usually reported with a same day E/M visit. However, as observers to the RUC process, we have noted a general tendency for the RUC to recommend only minor adjustments in physician time and direct PE inputs to account for overlap. We also often make adjustments to the RUC recommended valuation in cases where the agency believes there is overlap between services frequently billed together that has not been adequately addressed through the RUC process. More importantly, even if the RUC valuation process better accounted for the overlapping resource costs, those adjustments would be made to national valuation of particular codes based on snapshot, national claims data for a given year, and would apply to all physicians reporting the services regardless of whether or not these particular physicians were achieving the efficiencies that occur when visits are reported on the same day as codes with global periods. Because this dynamic is an inherent part of valuation based on the typical case for discrete services, we routinely prioritize review of high-volume services. However, we believe the application of this methodology in valuing global services is particularly problematic because there are several thousand codes with global periods and it is impractical to conduct these kinds of code-level reviews as frequently as would be necessary to improve the accuracy of accounting for these efficiencies.
We agree with commenters that if practitioners began deliberately scheduling visits on separate days, when they could be furnished together on the same day, in order to avoid the payment adjustment that could create a significant undue burden for beneficiaries. We have heard this concern before regarding other MPPRs. We note that we have major concerns about this kind of manipulation of patient scheduling, especially as it relates to the fundamental requirement that Medicare payment may be made only for reasonable and necessary medical care, and intend to consider this concern more broadly for future rulemaking. Because we are obligated to develop PFS payments based on the relative resources involved in furnishing services, we believe the total of payments to practitioners for physicians' services from both Medicare and beneficiaries should reflect efficiencies inherent in furnishing two services that can be furnished together without prompting manipulative scheduling practices that result in inconvenience and potential medical risks to Medicare beneficiaries.
After consideration of the public comments, we recognize that we must balance concerns about appropriate valuation with the potential disruptions to patient care suggested by commenters. Though we find the possible practice of scheduling medical services to maximize payment without regard to patient needs or costs to be highly problematic, we take these concerns seriously given the broad-based consensus within the medical and stakeholder community regarding likely behavioral changes in response to the proposal. After weighing these concerns, we are not finalizing the proposal to apply an MPPR to a separately identifiable office/outpatient E/M visit furnished on the same day as a global procedure. We intend to consider ways to address the practice of scheduling patients to avoid payment adjustments in future rulemaking.
Given the variety of comments we received regarding the valuation of specific codes, especially codes with global periods that are perceived to include no resource costs associated with evaluation and management, we intend to reconsider the appropriate global period assigned to certain services. We welcome stakeholder input regarding appropriate global period assignment through our routine valuation processes. We will also continue to consider how to address what we believe to be a significant problem of accurately accounting for duplicative resource costs in ways that will protect Medicare beneficiaries' access to appropriate care.
The distribution of E/M visits is not uniform across medical specialties. We have found that certain specialists, like neurologists and endocrinologists, for example, bill higher level E/M codes more frequently than procedural specialists, such as dermatologists. We believed this tendency reflects a significant and important distinction between the kinds of E/M visits furnished by professionals whose treatment approaches are primarily reported using visit codes versus those professionals whose treatment approaches are primarily reported using available procedural or testing codes. However, based on feedback we received from the medical professionals who furnish primary care and have visits with greater complexity, we did not believe the current visit definitions and the associated documentation burdens are the most accurate descriptions of the variation in work. Instead, we believed these professionals have been particularly burdened by the documentation requirements, given that so much of their medical treatment is
Similarly, stakeholders such as the commenters responding to the CY 2018 PFS proposed rule have articulated persuasively that visits furnished for the purpose of primary care also involve distinct resource costs. In developing this proposal, we consulted a variety of resources, including the American Academy of Family Physicians (AAFP) definition of primary care that states that the resource costs associated with furnishing primary care services particularly include time spent coordinating patient care, collaborating with other physicians, and communicating with patients (see
We proposed to create a HCPCS G-code for primary care services, HCPCS code GPC1X (Visit complexity inherent to evaluation and management associated with primary medical care services that serve as the continuing focal point for all needed health care services (Add-on code, list separately in addition to an established patient evaluation and management visit)). As we believe a primary care visit is partially defined by an ongoing relationship with the patient, this code would describe furnishing a visit to an established patient. HCPCS code GPC1X could also be reported for other forms of face-to-face care management, counseling, or treatment of acute or chronic conditions not accounted for by other coding. We noted that we believed the additional resources to address inherent complexity in E/M visits associated with primary care services are associated only with stand-alone E/M visits as opposed to separately identifiable visits furnished within the global period of a procedure. Separately identifiable visits furnished within a global period are identified on the claim using modifier -25, and would be subject to the MPPR. We noted that we created separate coding that describes non-face-to-face care management and coordination, such as CCM and BHI; however, these services describe non-face-to-face care and can be provided by any specialty as long as they meet the requirements for those codes. HCPCS code GPC1X was intended to capture the additional resource costs, beyond those involved in the base E/M codes, of providing face-to-face primary care services for established patients. HCPCS code GPC1X would be billed in addition to the E/M visit for an established patient when the visit includes primary care services. For HCPCS code GPC1X, we proposed a work RVU of 0.07, physician time of 1.75 minutes, no direct PE inputs, and an MP RVU of 0.01. This proposed valuation accounted for the additional resource costs associated with furnishing primary care that distinguishes E/M primary care visits from other types of E/M visits, and would maintain work budget neutrality across the office/outpatient E/M code set. Furthermore, the proposed add-on G-code for primary care-focused E/M services would help to mitigate potential payment instability that could result from our adoption of single payment rates that apply for E/M code levels 2 through 5. As this add-on G-code would account for the inherent resource costs associated with furnishing primary care E/M services, we anticipated that it would be billed with every primary care-focused E/M visit for an established patient. Although we expected that this code would mostly be utilized by the primary care specialties, such as family practice or pediatrics, we were also aware that, in some instances, certain specialists function as primary care practitioners—for example, an OB/GYN or a cardiologist. Although the definition of primary care is widely agreed upon by the medical community and we intended for this G-code to account for the resource costs of performing those types of visits, regardless of Medicare enrollment specialty, we also solicited comment on how best to identify whether or not a primary care visit was furnished, particularly in cases where a specialist is providing those services. For especially complex patients, we also expected that this G-code would be billed alongside the new code we proposed for prolonged E/M services described later in this section.
We also solicited comment on whether this policy adequately addresses the deficiencies in CPT coding for E/M services in describing current medical practice, and concerns about the impact on payment for primary care and other services under the PFS.
We also proposed to create a HCPCS G-code to be reported with an E/M service to describe the additional resource costs for specialty professionals for whom E/M visit codes make up a large percentage of their overall allowed charges and whose treatment approaches we believed are generally reported using the level 4 and level 5 E/M visit codes rather than procedural coding. Due to these factors, the proposed single payment rate for E/M levels 2 through 5 visit codes would not necessarily reflect the resource costs of those types of visits. Therefore, we proposed to create a new HCPCS code GCG0X (Visit complexity inherent to evaluation and management associated with endocrinology, rheumatology, hematology/oncology, urology, neurology, obstetrics/gynecology, allergy/immunology, otolaryngology, cardiology, or interventional pain management-centered care (Add-on code, list separately in addition to an evaluation and management visit)). Given their billing patterns, we believed that these are specialties that apply predominantly non-procedural approaches to complex conditions that are intrinsically diffuse to multi-organ or neurologic diseases. Although some of these specialties are surgical in nature, we believed these surgical specialties are providing increased non-procedural care of high complexity in the Medicare population. The high complexity of these services is reflected
Given the broad scope of our proposals related to E/M services, we solicited feedback on any unintended consequences of those proposals. We also solicited comment on any other concerns related to primary care that we might consider for future rulemaking.
Some commenters suggested that ambiguity around the definition of the primary care add-on would create additional documentation burden and concern regarding audit risk. For example, many commenters presented examples of physicians of many different specialties furnishing particular services that might be considered to be primary care, such as when a dermatologist prescribes an anti-hypertensive medication, and what documentation would be required to justify billing of the add-on code.
In response to CMS' solicitation for accepted definitions of primary care, the AAFP stated that primary care services are performed by practitioners “specifically trained for and skilled in comprehensive first contact and continuing care for persons with any undiagnosed sign, symptom, or health concern.” The primary care physician “provides definitive care to the undifferentiated patient at the point of first contact and takes continuing responsibility for providing the patient's comprehensive care.” Because the definition of a primary care service hinges on the ongoing relationship with the patient, the AAFP recommended that the add-on code not be limited to established patients, but expanded to new patients when the physician has an expectation that an ongoing relationship will develop.
In response to CMS' request for comment on the circumstances when it would be appropriate for a specialist to bill for primary care services, the AAFP stated that while physicians who are not trained in the core primary care specialties can provide services focused on “specific patient care needs related to prevention, health maintenance, acute care, chronic care, or rehabilitation” but not within the context of “comprehensive, first contact, and continuing care.” Therefore, the AAFP stated that these practitioners were not providing primary care.
For example, a 68-year-old woman with progressive congestive heart failure (CHF), diabetes and gout on multiple medications transfers care to a new primary care clinician. During a visit to establish care, the clinician discusses the patient's current health issues that includes confirmation that her CHF symptoms have remained stable over the past 3 months. She also denies symptoms to suggest hyper or hypoglycemia, but does note pain in her right wrist and knee. Based on the patient's history, physical exam findings and discussion, the clinician adjusts the dosage of some of the patient's medications, instructs the patient to take acetaminophen for her joint pain, request copies of prior diagnostic studies from his former providers, and orders laboratory tests to assess glycemic control, metabolic status and kidney function. The practitioner also discusses age appropriate prevention with the patient and orders a pneumonia vaccination and screening colonoscopy.
In this case, since the practitioner is furnishing care for conditions across a spectrum of diagnoses and organ systems and coordinating the patient's care among multiple health care providers, the practitioner would report the primary care resource add-on with the appropriate E/M code. We anticipate that the issues addressed by a physician will often track with the physician's specialty training. Therefore, it would not be unexpected for this physician to be reporting the primary care resource add-on code for almost all E/M visits, provided they are furnishing primary care during those visits. We would expect that claims records would include the billing physician's specialty and that the medical record would include the diagnoses for the patient, and the clinician's assessment and plan for that visit. This information would serve as sufficient documentation that the furnished visit met the primary care complexity description and so there would be no need to provide additional documentation.
We agree with AAFP that the vast majority of visits billed with the primary care complexity add-on would be performed by the previously mentioned specialties; however, we also recognize that there is not consensus among medical specialties on this definition. We also believe that there are clinical scenarios when a specialist may perform primary care. For example:
A cardiologist serving beneficiaries in a rural location provides care for complex cardiac conditions as well as primary care in her clinical practice. This practitioner sees a 75-year-old female with hypertension, coronary artery disease, and osteoarthritis for routine follow up care. During the visit, the patient describes a worsening pain in her hip and dizziness for the past month. The clinician notes gait instability and painful motion of her hip, and significant orthostasis upon standing. The clinician observes that the patient has made errors in filling her pill box, and has a new counter anti-histamine that the patient obtained from her friend to help with sleep. The clinician conducts a brief cognitive test, ascertains that the patient had not fallen, and recommends stopping the anti-cholinergic medication, and adjustment of her blood pressure medications with close follow-up monitoring. In addition to reviewing the patients' cardiac status, initiating imaging to evaluate the hip, the clinician also recommends a home safety evaluation and schedules a follow-up visit to include her adult daughter who lives nearby. In this case, since the clinician is furnishing primary care services as well as specialty cardiology services, the physician would appropriately be reporting the primary care complexity add-on in addition to the appropriate E/M visit code. We would expect that the claims record would include the billing physician's specialty. The medical record would also include the diagnoses for the patient and clinician's assessment and plan for that visit.
This information would serve as sufficient documentation that the furnished visit met the primary care and non-procedural specialty care complexity adjustment descriptions and so there would be no need to provide additional documentation.
The AAFP did not support the add-on code, and instead suggested that CMS provide a 15 percent increase in payment to physicians who list their primary practice designation as family medicine, internal medicine, pediatrics, or geriatrics.
Many commenters were also concerned about the documentation requirements that would be associated with the new coding, stating that CMS was replacing the burden of documenting the level of E/M visit with the burden of documenting proper use of the visit complexity add-ons. A few commenters did support the add-on codes in concept as a useful way of adjusting payment for different types of visits, although several commenters pointed out that the add-on codes were not valued sufficiently to overcome any reduction in payment due to the proposed single payment rate for visit levels. Commenters requested that CMS clarify whether the add-on codes could be billed concurrently for the same visit.
A clinical scenario for the use of this proposed add-on code would be a 72-year-old female with colon cancer who sees her oncologist to discuss her treatment plan, including surgical and chemotherapeutic options. Since this E/M visit focuses on oncologic care, the physician would report the specialty care add-on in addition to the appropriate E/M visit code. It would not be unexpected for this physician to be reporting the non-procedural specialty care complexity add-on code for almost all E/M visits, provided they are providing oncologic care during those visits. We would expect that the claims record would include the billing physician's specialty. The medical record would also include the diagnoses for the patient and clinician's assessment and plan for that visit. This information would serve as sufficient documentation that the furnished visit met the description of non-procedural specialty care complexity and so there would be no need to provide additional documentation.
We also agree with commenters that the code descriptor omitted several specialties that provide this type of visit, such as nephrology, psychiatry, pulmonology, infectious disease, and hospice and palliative care medicine. We also believe that there are circumstances where specialties not included in the code descriptor would appropriately bill this add-on code for inherent visit complexity. As discussed previously, appropriate reporting of the specialty care resource add-on code should be apparent based on the nature of the clinical issues addressed at the E/M visit, and not limited by the practitioner's specialty.
In cases where appropriate reporting of the add-on code is not as apparent, we understand that some degree of visit-specific documentation might be necessary for purposes of demonstrating that the add-on code was reported appropriately. For example, a physician enrolled in Medicare as a pathologist may serve a broader role in a rural community, including furnishing primary care. In this instance, we expect that there would be documentation in the medical record to illustrate that it was appropriate for this physician to bill using the primary care complexity add-on. However, we do not believe that such scenarios would represent the majority of instances of appropriate use of the code. Additionally, we note that information usually included in medical documentation, combined with diagnosis coding, would likely suffice for purposes of documentation.
After consideration of the comments, we are finalizing for 2021 the proposal to introduce add-on codes that would adjust payment for new and established E/M office/outpatient visits to account for inherent complexity in primary care and non-procedural specialty care. We are finalizing the code descriptor for the add-on code for inherent complexity of E/M furnished primary care (HCPCS code GPC1X) as described in Table 22. We are also finalizing the code descriptor for the add-on code for inherent complexity of E/M furnished with non-procedural specialty care (HCPCS code GCG0X) in Table 22, and we note that we have included refinements to refer to additional kinds of non-procedural specialty care as suggested by commenters and clarifying that it could be reported for both new and established patients. We note that we are not including in the descriptor references to specialty care that routinely involves significant procedural interventions, such as interventional radiology and dermatology, since we do not agree with commenters that these kinds of specialty care are routinely considered to be “non-procedural specialist care.” However, we note that when clinical circumstances support it, practitioners not enrolled among the specialties expressly listed within the code descriptor may bill the inherent visit complexity add-on codes. We are also finalizing as proposed the code descriptor for inherent complexity of E/M furnished with primary care (HCPCS code GPC1X) with the refinement of including that it could be reported for both new and established patients. The add-on codes to account for inherent complexity in primary care and non-procedural specialty care could only be reported with E/M office/outpatient levels 2 through 4 visits. We note that for this and the other HCPCS G-codes we are finalizing for CY 2021, we are retaining the placeholder HCPCS code numbers until they are replaced through our standard process.
We again note that we are finalizing the add-on codes for primary care and non-procedural specialized care complexity adjustment, as well as other payment and coding changes to be implemented for E/M office/outpatient visits for CY 2021. We are specifying the later date, in great part, so that we have an opportunity to fully consider public comments and other important input from stakeholders on potential refinements in code and service definitions that can be used with ease, when appropriate, and by practitioners whom we currently believe are disproportionately burdened under the current coding and documentation requirements and, more generally, other important information involving coding and payment for E/M services.
After considering the public comments, we agree that the complexity associated with furnishing a primary care visit is equivalent to that associated with furnishing a non-procedural specialty care visit, and therefore, the two codes should be valued equally. We are finalizing, for 2021, the input values for these two codes as reflected in Table 23.
We note that these inputs reflect our proposed valuation of the non-procedural specialty complexity code, based on a modified crosswalk from CPT code 90785 as discussed in the CY 2019 PFS proposed rule (83 FR 35842).
We also note that, while our policy will result in our inclusion of these input values in developing proposed rates for CY 2021, we also recognize that we routinely accept recommendations from the RUC and other stakeholders regarding appropriate valuation for PFS services, and would consider such recommendations regarding appropriate valuation for these services under our usual, annual process for receiving recommendations for PFS services.
In response to the commenters' concerns regarding the interactions between this code and the other codes that describe more complex E/M visits, we are clarifying that these add-on codes are intended to serve as a corollary to the single payment rate for E/M office/outpatient visit codes defined as levels 2 through 4 to provide for more appropriate recognition of the variations in resources involved in furnishing those services, and not to be used in association with E/M office/outpatient level 1 or level 5 visits.
While we believe that in most cases practitioners would only be reporting either the primary care complexity code or non-procedural specialty care complexity code, we believe there are some very rare circumstances where use of both codes might be appropriate. We return to our example of the cardiologist serving beneficiaries in a rural location who provides care for complex cardiac conditions as well as primary care in her clinical practice. Since the needs of the community prompt this physician to provide primary care services as well as specialty cardiology services, we would expect that she would report the primary care complexity add-on code and non-procedural specialty care complexity add-on code in addition to the appropriate E/M visit code when both primary care and non-procedural specialty care are furnished in connection with E/M visits.
As described earlier, the vast majority of podiatric visits are reported using lower level E/M codes, with most E/M visits billed at a level 2 or 3, reflecting the type of work done by podiatrists as part of an E/M visit. Therefore, while the proposed consolidation of documentation and payment for E/M code levels 2 through 5 was intended to better reflect the universal elements of E/M visits across specialties and patients, we believed that podiatric E/M visits were not accurately represented by the consolidated E/M structure. In order for payment to reflect the resource costs of podiatric visits, we proposed to create two HCPCS G codes, HCPCS codes GPD0X (Podiatry services, medical examination and evaluation with initiation of diagnostic and treatment program, new patient) and GPD1X (Podiatry services, medical examination and evaluation with initiation of diagnostic and treatment program, established patient), to describe podiatric E/M services. Under this proposal, podiatric E/M services would be billed using these G-codes instead of the generic office/outpatient E/M visit codes (CPT codes 99201 through 99205 and 99211 through 99215). We proposed to create these separate G-codes for podiatric E/M services to differentiate the resources associated with podiatric E/M visits rather than propose a negative add-on adjustment relative to the proposed single payment rates for the generic E/M levels 2 through 5 codes. Therefore, we proposed to create separate coding to describe these services, taking into account that most podiatric visits are billed as level 2 or 3 E/M codes. We based the coding structure and code descriptor on CPT codes 92004 (Ophthalmological services: Medical examination and evaluation with initiation of diagnostic and treatment program; comprehensive, new patient, 1 or more visits) and 92012
We also acknowledge that our proposal should have clearly articulated that we were not proposing to prohibit podiatrists from reporting the E/M office/outpatient visit codes under circumstances where those codes more accurately described visits with particular patients or, more broadly, visits generally furnished by particular podiatrists.
We also would like to note that our analysis of claims data indicates that the vast majority of podiatric visits are reported as level 2 and 3 visits. We believe that these claims data are an important piece of evidence regarding the relative resource costs of office/outpatient visits that are podiatric in nature. Therefore, we do not agree with the commenters that stated that our proposal did not reflect resource-based valuation, since we consider Medicare claims data to be one of the best sources of data regarding the resources involved in furnishing PFS services.
After considering the comments regarding this proposal, we are not finalizing our proposal to create separate coding for podiatric E/M services and establish payment rates for podiatric E/M visits based on historical billing patterns. We acknowledge the commenters' concerns that creating specific coding as we proposed could suggest a devaluation of services furnished by podiatrists. Therefore, we are not finalizing creation of specific coding and payment values for podiatric E/M visits. For CY 2021, podiatric E/M visits would be reported and paid using the E/M coding and payment structure applicable to other E/M office/outpatient visits.
As we explain in section II.B. of this final rule, Determination of Practice Expense (PE) Relative Value Units (RVUs), we generally allocate indirect costs for each code on the basis of the direct costs specifically associated with a code and the greater of either the clinical labor costs or the work RVUs. Indirect expenses include administrative labor, office expense, and all other PEs that are not directly attributable to a particular service for a particular patient. Generally, the proportion of indirect PE allocated to a service is determined by calculating a PE/HR based upon the mix of specialties that bill for a service.
As described earlier, E/M visits comprise a significant portion of allowable charges under the PFS and are used broadly across specialties such that our proposed changes can greatly impact the change in payment at the specialty level and at the practitioner level. Our proposals sought to simplify payment for E/M visit levels 2 through 5, and to additionally take into consideration that there are inherent differences in primary care-focused E/M services and in more complex E/M services such that those visits involve greater relative resources, while seeking to maintain overall payment stability across specialties. However, establishing a single PFS rate for new and established patient E/M levels 2 through 5 would have a large and unintended effect on many specialties due to the way that indirect PE is allocated based on the mixture of specialties that furnish a service. The single payment rates proposed for E/M levels 2 through 5 could not reflect the indirect PE previously allocated differentially across those 8 codes. Historically, a broad blend of specialties and associated PE/HR has been used in the allocation of indirect PE and MP RVUs to E/M services to determine payment rates for these services. As this proposal would have significantly altered the PE/HR allocation for the office/outpatient E/M codes and any previous opportunities for the public to comment on the data would not have applied to these kinds of E/M services, we did not believe it was in the public interest to allow the allocation of indirect PE to have such an outsized impact on the payment rates for this proposal. Due to the magnitude of the proposed coding and payment changes for E/M visits, it was unclear how the distribution of specialties across E/M services would change. We were concerned that such changes could produce anomalous results for indirect PE allocations since we did not yet know the extent to which specialties would utilize the proposed simplified E/M codes and proposed G-codes. In the past, when utilization data are not available or do not accurately reflect the expected specialty mix of a new service, we have proposed to crosswalk the PE/HR value from another specialty (76 FR 73036). As such, we proposed to create a single PE/HR value for E/M visits (including all of the proposed HCPCS G-codes discussed above) of approximately $136, based on an average of the PE/HR across all specialties that bill these E/M codes, weighted by the volume of those specialties' allowed E/M services. We believed that this was consistent with
The following is a summary of the comments we received on this proposal.
After consideration of these comments, we will not be finalizing a separate PE/HR for office/outpatient E/M visits.
Time is often an important determining factor in the level of care, which we consider in our proposal described earlier that physicians and other practitioners can use time as the basis for documenting and billing the appropriate level of E/M visit for purposes of Medicare payment. Currently there is inadequate coding to describe services where the primary resource of a service is physician time. CPT codes 99354 (Prolonged evaluation and management or psychotherapy service(s) (beyond the typical service time of the primary procedure) in the office or other outpatient setting requiring direct patient contact beyond the usual service; first hour (List separately in addition to code for office or other outpatient Evaluation and Management or psychotherapy service)) and 99355 (Prolonged evaluation and management or psychotherapy service(s) (beyond the typical service time of the primary procedure) in the office or other outpatient setting requiring direct patient contact beyond the usual service; each additional 30 minutes (List separately in addition to code for prolonged service)) describe additional time spent face-to-face with a patient and may be billed when the applicable amount of time exceeds the typical service time of the primary procedure.
Stakeholders have informed CMS that the “first hour” time threshold in the descriptor for CPT code 99354 is difficult to meet and is an impediment to billing these codes (81 FR 80228). In response to stakeholder feedback and as part of our proposal to implement a single payment rate for E/M visit levels 2 through 5 while maintaining payment accuracy across the specialties, we proposed to create a new HCPCS code GPRO1 (Prolonged evaluation and management or psychotherapy service(s) (beyond the typical service time of the primary procedure) in the office or other outpatient setting requiring direct patient contact beyond the usual service; 30 minutes (List separately in addition to code for office or other outpatient Evaluation and Management or psychotherapy service)). Given that the physician time of HCPCS code GPRO1 is half of the physician time assigned to CPT code 99354, we proposed a work RVU of 1.17, which is half the work RVU of CPT code 99354.
We appreciate commenters' concerns regarding the current definitions and use of “prolonged” as applying to unusually long visits. We believe that time spent with patients ought to vary based on the particular needs of the patient and that variations in time spent face-to-face with the patient can be critical in defining differences between the services being furnished. Consequently, we agree that for many practitioners, times that extend beyond what we, or the CPT Editorial Panel, consider to be typical under the current visit code descriptors and definitions, might, in actual practice, be routine. We also note that many services, such as psychotherapy, are currently defined and paid based on the duration of the service.
However, since commenters have suggested that the term “prolonged” has been established in coding convention as applying only to unusually long visits as opposed to use in describing routine variations in the amount of time spent during visits with patients, we believe using an alternative term, like “extended visit” may serve to underscore our expectation that the length of some visits might exceed the typical length, but would not be unusual for certain practices or patients.
We also note that, for audit purposes, we would expect the medical record to reflect that the billing practitioner actually spent the amount of time with the patient described by the code and that the visit itself, in its entirety, was medically necessary; but we would not
For CY 2021, we are finalizing a coding and payment policy to account for the additional resources required when practitioners need to spend extended time with their patients during particular E/M office/outpatient level 2 through 4 visits, regardless of the kind of care the practitioner is furnishing or whether or not the medical complexity of the visit is the determining factor for the length of visit. After considering the comments, we believe that 30 additional minutes (which, in accordance with CPT coding conventions for timed codes, can be reported after 15 additional minutes is spent with the patient) is an appropriate interval of time after which to reflect the additional resource costs associated with patient visits that require more time than is typical for the visit. After considering the questions and concerns expressed by commenters about how the new add-on code would be used, and in particular, the number of minutes that would serve as the basis for counting time toward an extended visit (for example, whether we would look to the typical time for the companion E/M code level and use the CPT coding convention for time-based codes), we acknowledge that it would not be workable to use the same conventions as are used for the prolonged service codes.
Under the current conventions used in reporting the existing prolonged service codes, the prolonged codes are defined by a set number of additional minutes beyond time associated with individual companion visit codes. For example, the initial prolonged services code describes 60 minutes of prolonged time beyond the time associated with the individual companion visit code. The current level 5 existing patient code is described by CPT as typically requiring 40 minutes with the patient, so that when reporting 99215 with the prolonged service code, the time being described is a total of 100 minutes (40 minutes for the level 5 code and 60 minutes for the initial prolonged code). Under applicable coding conventions, the code is reportable, when at least half the number of described minutes for the prolonged code is spent. This means that the initial prolonged service code can be reported with a level 5 existing patient code after 70 minutes (40 minutes for the full time associated with the level 5 visit and 30 minutes for half the number of minutes described by the initial prolonged service code).
We recognize that to implement use of either new or even the existing prolonged services code in the context of using a single payment rate for codes of varying levels, we would need to be clear about what time should be used for the companion visit codes. Currently, practitioners rely on the CPT “typical” times to determine the time for the visit codes of varying levels. This means that the thresholds for visit time required before the prolonged services can be reported are higher when higher level visits are reported in comparison to lower level visits. Under current payment rates, this situation is offset to some degree by the higher overall payment in circumstances where the higher level visit code is reported.
Because we are finalizing a single payment rate for levels 2-4, however, use of the “typical” CPT times as the basis for reporting add-on codes that describe additional time would mean that lower level visits that take more time would be paid at higher rates than higher visit rates that take the same amount of time. We believe that because we are paying a single rate for these services (as each of the codes describe a single “typical” for purposes of payment), we should also use a single number of minutes for purposes of reporting time-based add-on codes: The weighted average of the “typical” times associated with each of the codes that comprise the single payment rate.
One approach to implementing this would be to revise our billing rules to instruct practitioners to use the weighted average of the “typical” times associated with each of the codes that comprise the single payment rate, instead of the “typical” CPT times associated with the individual billed codes. We could apply this definition broadly to specify use of the weighted average typical times for level 2-4 codes regardless of whether or not they are being reported with time-based add-on codes, but we do not want to prevent practitioners from appropriately reporting visits based on the time defined as typical under the CPT code descriptors for office/outpatient E/M visits, especially since we are adopting a policy to allow clinicians to use time as the basis for documentation and code selection. Alternatively, we could require practitioners to use the weighted average of the “typical” times associated with each of the codes that comprise the single payment rate only in cases where time-based add-on codes are also being reported. However, we believe using two separate rules, especially one that deviates from the typical times established for the different visit levels that will continue to be routinely reported by a wide range of practitioners, would be likely to cause confusion.
After consideration of these issues and considering the alternatives, we are finalizing a code descriptor for the extended visit code that describes a single range of minutes that applies to the overall duration of face-to-face time during the visit, without regard to which level 2, 3, or 4 E/M office/outpatient visit was reported. This range is 34 to 69 minutes, so that the add-on code for extended visits would be appropriately reported in any case where a medically necessary E/M office/outpatient visit, reported using levels 2 through 4, required between 34 and 69 minutes (for established patients) and between 38 and 89 minutes (for new patients) of face-to-face time with the billing practitioner. We calculated the lower end of the range by summing the weighted average of intraservice times for the component codes that make up the single payment rate for level 2 through 4 visits (23 minutes for new and 19 minutes for established) and the additional amount of time required to bill the proposed add-on code (15 minutes under coding convention for prolonged services). The upper range of the use of the extended visit code is 69 minutes for established patients and 89 minutes for new patients.
We note that to report the current prolonged codes or the new extended services code, practitioners need to note that the requisite number of minutes were spent with the patient. We also note that we are finalizing the policy to allow practitioners the choice to use time as the basis for code selection for level 2 through 5 all office/outpatient E/M codes beginning in 2021 regardless of whether or not counseling and/or coordination of care accounts for more than 50 percent of the face-to-face physician/patient encounter. Under the new policy, then, any visits that exceed the length of the time ranges of the level 2 through 4 visit codes plus the extended visit code, could be reported using the level 5 visit code and the existing prolonged services code. Table 24A illustrates these rules:
The new extended services code will be described as GPRO1 (Extended time for evaluation and management service(s) in the office or other outpatient setting, when the visit requires direct patient contact of 34-69 total face-to-face minutes overall for an existing patient or 38-89 minutes for a new patient (List separately in addition to code for level 2 through 4 office or other outpatient Evaluation and Management service)). We again note that we are finalizing payment and coding changes to be implemented for E/M office/outpatient visits for CY 2021. We will consider any changes that are made to CPT coding, including for prolonged services, and recommendations regarding appropriate valuation of new or revised codes, through our annual rulemaking process.
In order to estimate the potential impact of the proposed changes in the proposed rule, we modeled the results of several options and examined the estimated resulting impacts in overall Medicare allowed charges by physician specialty. Because we are not finalizing many of the changes for CY 2019 as proposed, we believe the inclusion of those same discussions in this final rule is unnecessary and could potentially be confusing. We point readers to the CY 2019 PFS proposed rule, (83 FR 35844 through 35847) for discussion of the analyses relevant to the proposals. For analysis regarding the potential impacts of the alternatives considered in development of this final rule, we direct readers to the section VII. of this final rule, Regulatory Impact Analysis, in addition to the discussion that follows.
To compare the overall payment impact for the changes in payment for visit services between the current policy as of 2018 and the policies we are finalizing starting in 2021, we provide a narrative example in the paragraph below and Table 24B. In CY 2018, a physician would bill a level 4 E/M visit and document using the existing documentation framework for a level 4 E/M visit. The payment rate would be approximately $109 in the office setting. In CY 2021, the physician would bill the same visit code for a level 4 E/M visit, with the option to document the visit according to the minimum documentation requirements for a level 2 E/M visit if they choose to document based on MDM, or the 1995 or 1997 guidelines, or to document on the basis of time. The physician might also bill either of the proposed add-on codes (HCPCS codes GPC1X or GCG0X) depending on the type of patient care furnished, and could bill the extended services code if she met the time threshold for this code. The combined payment rate for the E/M visit code, plus the extended services code, and either HCPCS code GPC1X or GCG0X would be approximately $170.
We considered a number of other options for simplifying coding and payment for E/M services to align with the proposed reduction in documentation requirements and to better account for the resources associated with inherent complexity, visit complexity, and visits furnished on the same day as a 0-day global procedure. As we are finalizing a policy very similar to one of the alternatives we considered for the proposed rule, we believe it would be confusing to include a detailed discussion of that policy as an alternative considered. We therefore direct interested readers to the CY 2019 PFS proposed rule (83 FR 35847).
Section 101(f) of the MACRA added a new subsection (r) under section 1848 of the Act entitled Collaborating with the Physician, Practitioner, and Other Stakeholder Communities to Improve Resource Use Measurement. Section 1848(r) of the Act requires the establishment and use of classification code sets: Care episode and patient condition groups and codes; and patient relationship categories and codes. As described in the CY 2018 PFS final rule, we finalized use of Level II HCPCS Modifiers as the patient relationship codes and finalized that Medicare claims submitted for items and services furnished by a physician or applicable practitioner on or after January 1, 2018, should include the applicable patient relationship codes, as well as the NPI of the ordering physician or applicable practitioner (if different from the billing physician or applicable practitioner). We noted that for CY 2018, reporting of the patient relationship modifiers would be voluntary and the use and selection of the modifiers would not be a condition of payment (82 FR 53234). The patient relationship codes are as follows: X1: Continuous/broad; X2: Continuous/focused; X3: Episodic/focused; X4: Episodic/broad; and X5: Only as ordered by another physician. These codes are to be used to help define and distinguish the relationship and responsibility of a clinician with a patient at the time of furnishing an item or service, facilitate the attribution of patients and episodes to one or more clinicians, and to allow clinicians to self-identify their patient relationships.
We considered proposing the use of the care episode and patient relationship codes to adjust payment for E/M visits to the extent that these codes are indicative of differentiated resources provided in E/M visits, and we considered using these codes as an alternative to the proposed use of G-codes to reflect visit complexity inherent to evaluation and management in primary care and certain other specialist services, as a way to more accurately reflect the resource costs associated with furnishing different kinds of E/M visits. We solicited comment on this alternative. We were particularly interested in whether the modifiers would accurately reflect the differences between resources for E/M visits across specialties and would therefore be useful to adjust payment differentially for the different types of E/M visits that we previously identified. The following is a summary of the comments we received on these items.
In Table 24C, we estimate the specialty level impacts of the E/M payment and coding policies we are finalizing for 2021, calculated as if they were implemented for CY 2019.
Table 24C illustrates the estimated specialty level impacts associated with implementing our finalized policies for E/M coding and payment in CY 2019, rather than delaying until CY 2021. Table 24C shows the estimated impacts of adopting single payment rates for new and established patient E/M office/outpatient visit levels 2 through 4 (with the rates determined using input values that reflect the 5 year weighted average of current inputs for codes describing those visit levels), keeping separate rates for new and established patient E/M visit level 5 (with the rates determined using the current input values for level 5 visits), and adopting add-on codes with equal rates to adjust for the inherent visit complexity of primary care and non-procedural specialty care (with the rates determined using the input values from the proposed rule for the non-procedural specialty care complexity code). Under our finalized policies, specialties who disproportionately report lower level visits, such as podiatry, and specialties that report office/outpatient visits in conjunction with minor procedures, such as dermatology, would see the significant increases. Specialties that predominantly furnish higher level visits would have their payment decreases significantly mitigated by the maintenance of the level 5 visit and the add-on codes for inherent visit complexity for primary and non-procedural specialty care. Specialties that do not furnish office/outpatient visits generally would see modest reductions in overall payment.
We note that because our original proposal was developed more generally to maintain overall RVUs within the range of codes describing office/outpatient E/M visits, but, in response to public comment, we are not finalizing several elements of those proposals including, and especially, the multiple procedure payment reduction relating to global services billed with same day E/M services, the overall number of RVUs allocated to office/outpatient services would be increased relative to other PFS services. Under our established methodology and consistent with the governing statute, we usually apply a budget neutrality adjustment in the PFS conversion factor to account for the changes in overall RVUs. This adjustment would apply to all PFS services, and we are not finalizing any deviation from that approach for 2021. However, we also note that in some cases, we have proposed and finalized inputs for particular services that are designed to maintain the overall RVUs for those services despite changes in coding. For more detailed information on this approach to addressing valuation for families of services, we direct readers to the CY 2012 PFS final rule with comment period (76 FR 73105). We also note that while it has been our standard practice to avoid scaling the full set of work RVUs to maintain budget neutrality, we could also consider that alternative given the significance of office/outpatient visit codes in PFS relativity. Were we to consider either of these alternative
As we mentioned above, the E/M visit code set is comprised of individual subsets of codes that are specific to various clinical settings including office/outpatient, observation, hospital inpatient, emergency department, critical care, nursing facility, domiciliary or rest home, and home services. Some of these code subsets have three E/M levels of care, while others have five. Some of these E/M code subsets distinguish among levels based heavily on time, while others do not. Recent public comments have noted that some E/M code subsets intersect more heavily than others with hospital conditions of participation (CoP). For example, the American Psychiatric Association (APA) submitted a letter to CMS indicating that Medicare requires specific documentation in the medical record as part of the CoPs for inpatient psychiatric facilities. The APA believed that the required initial psychiatric evaluation for inpatients currently closely follows the E/M criteria for CPT codes 99221-99223, which are the codes that would be used to bill for these services. The APA stated that any changes in these E/M codes, without corresponding changes in the CoPs, could lead to the unintended consequence of adding to the burden of documentation by essentially requiring two different sets of data or areas of focus to be included, or two different documentation formats being required.
Regarding emergency department visits (CPT codes 99281-99285), we received more recent feedback through our coordinated efforts with ONC this year, emphasizing that these codes may benefit from a coding or payment compression into fewer levels of codes, or that documentation rules may need to be reduced or altered. However, in public comments to the CY 2018 PFS proposed rule, commenters noted several issues unique to the emergency department setting that we believe require further consideration. For example, commenters stated that intensity, and not time, is the main determinant of code level in emergency departments. They requested that CMS use caution in changing required elements for documentation so that medical information used for legal purposes (for example, meeting the prudent layperson standard) is not lost. They urged caution and requested that CMS not immediately implement any major changes. They recommended refocusing documentation on presenting conditions and medical decision-making. Some commenters were supportive of leaving it largely to the discretion of individual practitioners to determine the degree to which they should perform and document the history and physical exam in the emergency department setting. Other commenters suggested that CMS encourage use of standardized guidelines and minimum documentation requirements to facilitate post-treatment evaluation, as well as analysis of records for various clinical, legal, operational and other purposes. The commenters discussed the importance of extensive histories and exams in emergency departments, where usually there is no established relationship with the patient and differential diagnosis is critical to rule out many life-threatening conditions. They were cognizant of the need for a clear record of services rendered and the medical necessity for each service, procedure, diagnostic test, and MDM performed for every patient encounter.
In addition, although the RUC is in the process of revaluing this code set, some commenters stated that the main issue is not that the emergency department visit codes themselves are undervalued. Rather, these commenters noted that a greater percentage of emergency department visits are at a higher acuity level, yet payers often do not pay at a higher level of care and the visit is often inappropriately down-coded based on retrospective review. These commenters noted that the documentation needed to support a higher level of care is too burdensome or subjective. In addition, it seems that policy proposals regarding emergency department visits billed by physicians might best be coordinated with parallel changes to payment policy for facility billing of these codes, which would require more time and analyses.
Accordingly, we did not propose any changes to the emergency department E/M code set or to the E/M code sets for settings of care other than office-based and outpatient settings at this time. However, we solicited public comment on whether we should make any changes to it in future years, whether by way of documentation, coding, and/or payment and, if so, what the changes should be.
Consistent with public feedback to date, we are taking a step-wise approach and limiting our policy proposals this year to the office/outpatient E/M code set (and the limited proposal above regarding documentation of medical necessity for home visits in lieu of office visits). We may consider expanding our efforts more broadly to additional sections of the E/M visit code set in future years, and solicited public comment broadly on how we might proceed in this regard.
We received a few comments on this solicitation. We thank the commenters for their feedback and will take it into account for future rulemaking.
We proposed that our proposed E/M visit policies would be effective January 1, 2019. However, we were sensitive to commenters' suggestions that we should consider a multi-year process and proceed cautiously, allowing adequate time to educate practitioners and their staff; and to transition clinical workflows, EHR templates, institutional processes and policies (such as those for provider-based practitioners), and other aspects of practitioner work that would be impacted by these policy changes. We emphasized that our proposed documentation changes for office/outpatient E/M visits would be optional, and practitioners could choose to continue to document these visits using the current framework and rules, which may reduce the need for a delayed implementation. Nevertheless, practitioners who choose a new documentation framework may need time to deploy it. A delayed implementation date for our documentation proposals would also allow the AMA time to develop changes to the CPT coding definitions and guidance prior to our implementation, such as changes to MDM or code definitions that we could then consider for adoption. It would also allow other payers time to react and potentially adjust their policies. Accordingly, we solicited comment on whether a delayed implementation date, such as January 1, 2020, would be appropriate for our proposals.
Many stakeholders, including some commercial insurers and EHR-related associations, commented that if CMS were to finalize its proposals, the industry would need more time to prepare and CMS should delay implementation a year or more. Some commenters noted that CMS should consider not setting a date for implementation until the necessary structure is in place. Most commenters, including some insurers, urged CMS to work with the AMA or other stakeholders on alternative policies. For example, some insurers were concerned that the proposals would not allow them to understand the true complexity of care being delivered and recommended that documentation requirements should continue to be linked to complexity and, if the proposal were finalized, CMS would need to monitor various program integrity issues. They were concerned that the collapsed payment rate for level 2 through 5 E/M visits would disincentivize treatment of complex patients. Some health plans expressed concern that medical record data used to inform their payments and risk adjustment and HEDIS scores might be impacted. In response to our proposed rule, several organizations stated they are forming workgroups to conduct data analysis and develop policy alternatives, including the AMA and the Cognitive Care Alliance. The American Health Insurance Plans believed documentation requirements should continue to be linked to complexity.
Commenters were concerned there would not be enough time for developers and clinicians to make changes, leading to confusion in the market and disparate systems with other payers, in addition to other concerns about the coding and payment proposals discussed further below. The commenters were concerned about not having enough time to develop differing documentation based on payer status, and said that the burden on the clinician to determine which payer and which documentation method should not be underestimated.
Per 42 CFR part 415, subpart D, Medicare Part B makes payment under the PFS for teaching physician services when certain conditions are met, including that medical record documentation must reflect the teaching physician's participation in the review and direction of services performed by residents in teaching settings. Under § 415.172(b), for certain procedural services, the participation of the teaching physician may be demonstrated by the notes in the medical records made by a physician, resident, or nurse; and for E/M visits, the teaching physician is required to personally document their participation in the medical record. We received stakeholder feedback suggesting that documentation requirements for E/M services furnished by teaching physicians are burdensome and duplicative of notations that may have previously been included in the medical records by residents or other members of the medical team.
We proposed to revise our regulations to eliminate potentially duplicative requirements for notations that may have previously been included in the medical records by residents or other members of the medical team. These modifications are intended to align and simplify teaching physician E/M service documentation requirements. We believed these changes would reduce burden and duplication of effort for teaching physicians. We proposed to amend § 415.172(b) to provide that, except for services furnished as set forth in §§ 415.174 (concerning an exception for services furnished in hospital outpatient and certain other ambulatory settings), 415.176 (concerning renal dialysis services), and 415.184 (concerning psychiatric services), the medical records must document that the teaching physician was present at the time the service is furnished. Additionally, the revised paragraph would specify that the presence of the teaching physician during procedures and E/M services may be demonstrated by the notes in the medical records made by a physician, resident, or nurse. We also proposed to amend § 415.174, by deleting paragraph (a)(3)(v) which requires the teaching physician to document the extent of their participation in the review and direction of the services furnished to each beneficiary. We proposed to add new paragraph (a)(6) to § 415.174 to provide that the medical record must document the extent of the teaching physician's participation in the review and direction of services furnished to each beneficiary, and that the extent of the teaching physician's participation may be demonstrated by the notes in the medical records made by a physician, resident, or nurse.
Section 1848(e)(1)(C) of the Act requires us to review and, if necessary, adjust the GPCIs at least every 3 years. Section 1848(e)(1)(D) of the Act requires us to establish the GPCIs using the most recent data available. The last GPCI update was implemented in CY 2017; therefore, we are required to review and make any necessary revisions to the GPCIs for CY 2020. Please refer to the CY 2017 PFS final rule with comment period for a discussion of the last GPCI update (81 FR 80261 through 80270). Some commenters have continued to express concerns regarding some of the data sources used in developing the indices for PFS geographic adjustment purposes, specifically that we use residential rent data as a proxy for commercial rent in the rent index component of the PE GPCI—that is, the data that are used to develop the office rent component of the PE GPCI. We will continue our efforts to identify a nationally representative commercial rent data source that could be made available to CMS. In support of that effort, we were particularly interested in, and solicited comments regarding potential sources of commercial rent data for potential use in the next GPCI update for CY 2020.
We received a few comments in response to the comment solicitation, and we appreciate the commenters' feedback and input. We will consider the suggestions and information received for future rulemaking, and in particular for the CY 2020 statutorily required update to the GPCIs.
Section 50202 of the Bipartisan Budget Act of 2018 amended section 1833(g) of the Act, effective January 1, 2018, to repeal the application of the Medicare outpatient therapy caps and the therapy cap exceptions process while retaining and adding limitations to ensure therapy services are furnished when appropriate. Section 50202 also adds section 1833(g)(7)(A) of the Act which requires that after expenses incurred for the beneficiary's outpatient therapy services for the year have exceeded one or both of the previous therapy cap amounts, all therapy suppliers and providers must continue to use an appropriate modifier such as the KX modifier on claims for subsequent services in order for Medicare to pay for the services. We implemented this provision by continuing to use the existing KX modifier. By applying the KX modifier to the claim, the therapist or therapy provider is confirming that the services are medically necessary as justified by appropriate documentation in the medical record. Just as with the incurred expenses for the prior therapy cap amounts, there is one amount for physical therapy (PT) and speech language pathology (SLP) services combined and a separate amount for occupational therapy (OT) services. These KX modifier threshold amounts are indexed annually by the Medicare Economic Index (MEI). For CY 2018, the KX modifier threshold amount was $2,010 for PT and SLP services combined, and $2,010 for OT. After the beneficiary's incurred expenditures for outpatient therapy services exceed the KX modifier threshold amount for the year, claims for outpatient therapy services without the KX modifier are denied.
Along with the KX modifier thresholds, section 50202 also adds section 1833(g)(7)(B) of the Act that retains the targeted medical review (MR) process (first established through section 202 of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)), but at a lower threshold amount of $3,000. For CY 2018 (and each successive calendar year until 2028, at which time it is indexed annually by the MEI), the MR threshold is $3,000 for PT and SLP services and $3,000 for OT services. The targeted MR process means that not all claims exceeding the MR threshold amount are subject to review as they once were.
Section 1833(g)(8) of the Act, as re-designated by section 50202 of the Bipartisan Budget Act of 2018, retains the provider liability procedures which first became effective January 1, 2013, extending limitation of liability protections to beneficiaries who receive outpatient therapy services, when services are denied for certain reasons, including failure to include a necessary KX modifier.
Section 53107 of the Bipartisan Budget Act of 2018 (BBA of 2018) amended the Act to add a new subsection 1834(v) that addresses payment for outpatient therapy services for which payment is made under section 1848 or section 1834(k) of the Act that are furnished on or after January 1, 2022, in whole or in part by a therapy assistant (as defined by the Secretary). The new section 1834(v)(1) of the Act provides for payment of those services at 85 percent of the otherwise applicable Part B payment amount for the service. In accordance with section 1834(v)(1) of the Act, the reduced payment amount for such outpatient therapy services is applicable when payment is made directly under the PFS as specified in section 1848 of the Act, for example when payment is made to therapists in private practice (TPPs); and when payment is made based on the PFS as specified in section 1834(k)(3) of the Act, for example, when payment is made for outpatient therapy services identified in sections 1833(a)(8) and (9) of the Act, including payment to providers that submit institutional claims for therapy services such as outpatient hospitals, rehabilitation agencies, skilled nursing facilities, home health agencies and comprehensive outpatient rehabilitation facilities (CORFs). The reduced payment rate under section 1834(v)(1) of the Act for outpatient therapy services when furnished in whole or in part by a therapy assistant is not applicable to outpatient therapy services furnished by critical access hospitals for which payment is made as specified in section 1834(g) of the Act.
To implement this payment reduction, section 1834(v)(2)(A) of the Act requires us to establish a new modifier, in a form and manner specified by the Secretary, by January 1, 2019 to indicate, in the case of an outpatient therapy service furnished in whole or in part by a therapy assistant, that the service was furnished by a therapy assistant. Although we generally consider all genres of outpatient therapy services together (PT/OT/SLP), we did not believe there are therapy assistants in the case of SLP services, so we proposed to apply the new modifier only to services furnished in whole or in part by a physical therapist assistant (PTA) or an occupational therapy assistant (OTA). Section 1834(v)(2)(B) of the Act requires that each request for payment or bill submitted for an outpatient PT or OT
To implement this provision, we proposed to establish two new modifiers to separately identify PT and OT services that are furnished in whole or in part by PTAs and OTAs, respectively. We proposed to establish two modifiers because the incurred expenses for PT and OT services are tracked and accrued separately in order to apply the two different KX modifier threshold amounts as specified by section 1833(g)(2) of the Act; and the use of the two proposed modifiers would facilitate appropriate tracking and accrual of services furnished in whole or in part by PTAs and OTAs. We additionally proposed that these two new therapy modifiers would be added to the existing three therapy modifiers—GP, GO, and GN—that are currently used to identify all therapy services delivered under a PT, OT or SLP plan of care, respectively. The addition of the two new modifiers as therapy modifiers would bring the total to five therapy modifiers, with four therapy modifiers used to report and track PT and OT services, instead of two. The GP, GO, and GN modifiers have existed since 1998 to track outpatient therapy services that were subject to the therapy caps. Although the therapy caps were repealed through amendments made to section 1833(g) of the Act by section 50202 of the Bipartisan Budget Act of 2018, as discussed in the above section, the statute continues to require that we track and accrue incurred expenses for all PT, OT, and SLP services, including those above the specified per beneficiary amounts for medically necessary therapy services for each calendar year; one amount for PT and SLP services combined, and another for OT services.
For purposes of implementing section 1834(v) of the Act through rulemaking as required under section 1834(v)(2)(C) of the Act, we proposed to define therapy assistant as an individual who meets the personnel qualifications set forth at § 484.4 of our regulations for a PTA and OTA. We proposed that the two new therapy modifiers would be used to identify services furnished in whole or in part by a PTA or an OTA; and, that these new therapy modifiers would be used instead of the GP and GO modifiers that are currently used to report PT and OT services delivered under the respective plan of care whenever the service is furnished in whole or in part by a PTA or OTA.
Effective for dates of service on and after January 1, 2020, the new therapy modifiers that identify services furnished in whole or in part by a PTA or OTA would be required to be used on all therapy claims instead of the existing modifiers GP and GO, respectively. As a result, in order to implement the provisions of the new subsection 1834(v) of the Act and carry out the continuing provisions of section 1833(g) of the Act as amended, we proposed that, beginning in CY 2020, five therapy modifiers be used to track outpatient therapy services instead of the current three. These five therapy modifiers would include two new therapy modifiers to identify PT and OT services furnished by PTAs and OTAs, respectively, and three existing therapy modifiers—GP, GO and GN—that will be used when PT, OT, and SLP services, respectively, are fully furnished by therapists or when fully furnished by or incident to physicians and NPPs.
The creation of therapy modifiers specific to PT or OT services delivered under a plan of care and furnished in whole or in part by a PTA or OTA would necessitate that we make changes to the descriptors of the existing GP and GO modifiers to clarify which qualified professionals, for example, therapist, physician, or NPP, can furnish the PT and OT services identified by these modifiers, and to differentiate them from the therapy modifiers specific to the services of PTAs and OTAs. We also proposed to revise the GN modifier descriptor to conform to the changes to the GP and GO modifiers by clarifying the qualified professionals that furnish SLP therapy services.
We proposed to define the two new therapy modifiers for services furnished in whole or in part by therapy assistants and to revise the existing therapy modifier descriptors as follows:
• New PT Assistant services modifier (to be used instead of the GP modifier currently reported when a PTA furnishes services in whole or in part): Services furnished in whole or in part by a physical therapist assistant under an outpatient physical therapy plan of care;
• New OT Assistant services modifier (to be used instead of the GO modifier currently reported when an OTA furnishes services in whole or in part): Services furnished in whole or in part by occupational therapy assistant under an outpatient occupational therapy plan of care.
We proposed that the existing GP modifier, “Services delivered under an outpatient physical therapy plan of care” would be revised to read as follows:
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We proposed that the existing GO modifier, “Services delivered under an outpatient occupational therapy plan of care” would be revised to read as follows:
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We proposed that the existing GN modifier, “Services delivered under an outpatient speech-language pathology plan of care” would be revised to be consistent with the revisions to the GP and GO modifiers to read as follows:
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As finalized in CY 2005 PFS final rule with comment period (69 FR 66351 through 66354), and as required as a condition of payment under our regulations at §§ 410.59(a)(3)(iii), 410.60(a)(3)(iii), and 410.62(a)(3)(iii), the person furnishing outpatient therapy services incident to the physician, PA, NP or CNS service must meet the therapist personnel qualification and standards at § 484.4, except for licensure per section 1862(a)(20) of the Act. As such, we noted that only a therapist, not a therapy assistant, can furnish outpatient therapy services incident to the services of a physician or a non-physician practitioner (NPP), so the new PT- and OT-Assistant therapy modifiers cannot be used on the line of service when the rendering practitioner identified on the claim is a physician or an NPP. For therapy services billed by physicians or NPPs, whether furnished
We proposed that all services that are furnished in whole or in part by a PTA or OTA are subject to the use of the new therapy modifiers. A new therapy modifier would be required to be used whenever a PTA or OTA furnishes all or part of any covered outpatient therapy service. However, we did not believe the provisions of section 1834(v) of the Act were intended to apply when a PTA or OTA performs portions of the service such as administrative tasks that are not related to their qualifications as a PTA or OTA. Rather, we believed the provisions of section 1834(v) of the Act were meant to apply when a PTA or OTA is involved in providing some or all of the therapeutic portions of an outpatient therapy service. We proposed to define “in part,” for purposes of the proposed new modifiers, to mean any minute of the outpatient therapy service that is therapeutic in nature, and that is provided by the PTA or OTA when acting as an extension of the therapist. Therefore, a service furnished in part by a therapy assistant would not include a service for which the PTA or OTA furnished only non-therapeutic services that others without the PTA's or OTA's training can do, such as scheduling the next appointment, greeting and gowning the patient, and preparing or cleaning the room. We remind therapists and therapy providers that we do not recognize PTAs and OTAs to wholly furnish PT and OT evaluations and reevaluations, that is, CPT codes 97161 through 97164 for PT and CPT codes 97165 through 97168 for OT, but to the extent that they do furnish part of an evaluative service, the appropriate therapy modifier must be used on the claim to signal that the service was furnished in part by the PTA or OTA, and the payment reduction should be applied once it goes into effect. We continue to believe that the clinical judgment and decision making involved in furnishing an evaluation or re-evaluation is similar to that involved with establishing the therapy plan that can only be established by a therapist, physician, or NPP (NP, CNS, or PA) as specified in § 410.61 of our regulations. In addition, PTAs and OTAs are not recognized separately in the statute to enroll as practitioners for purposes of independently billing for their services under the Medicare program. For these reasons, Pub. 100-02, Medicare Benefits Policy Manual, Chapter 15, sections 230.1 and 230.2 state that PTAs and OTAs may not provide evaluative or assessment services, make clinical judgments or decisions; develop, manage, or furnish skilled maintenance program services; or take responsibility for the service. Although we expect that the therapist will continue to furnish the majority of an evaluative procedure service, section 1834(v)(1) of the Act requires that the adjusted payment amount (85 percent of the otherwise applicable Part B payment amount) be applied when a therapy assistant furnishes a therapy service in part, including part of an evaluative service.
Additionally, we would like to clarify that the requirements for evaluations, including those for documentation, are separate and distinct from those for plans of care (plans). The plan is a statutory requirement under section 1861(p) of the Act for outpatient PT services (and through sections 1861(g) and 1861(ll)(2) of the Act for outpatient OT and SLP services, respectively) and may only be established by a therapist or physician. Through § 410.61(b)(5), NPs, CNSs, and PAs are also permitted to establish the plan. This means that if the evaluative procedure is furnished in part by an assistant, the new therapy modifiers that distinguish services furnished by PTAs or OTAs must be applied to the claim; however, the plan, which is not separately reported or paid, must be established by the supervising therapist who furnished part of the evaluation services as specified at § 410.61(b). When an evaluative therapy service is billed by a physician or an NPP as the rendering provider, either the physician/NPP or the therapist furnishing the service incident to the services of the physician or NPP, may establish the therapy plan in accordance with § 410.61(b). All regulatory and subregulatory plan requirements continue to apply.
To implement the new statutory provision at section 1834(v)(2)(A) of the Act, we proposed to establish two new therapy modifiers to identify the services furnished in whole or in part by PTAs and OTAs. As required under section 1834(v)(2)(B) of the Act, claims from all providers of PT and OT services furnished on and after January 1, 2020, will be required to include these new PT- and OT-Assistant therapy modifiers for services furnished in whole or in part by a PTA or OTA. We proposed that these therapy modifiers would be required, when applicable, in place of the GP and GO modifiers currently used to identify all PT and OT services furnished under an outpatient plan of care, including the services furnished by PTAs and OTAs. To test our systems ahead of the required implementation date of January 1, 2020, we anticipated allowing voluntary reporting of the new modifiers at some point during CY 2019, which we would announce to our contractors, therapists and therapy providers through a Change Request, as part of our usual change management process.
We solicited comments on these proposals.
The following is a summary of the comments we received on these proposals.
After considering the comments on the establishment and use of the new modifiers, the statutory changes, and our other payment policies for therapy services, we are not finalizing the new modifiers for therapy assistant services as therapy modifiers as proposed. Instead, we will use the two new modifiers for therapy assistant services as a type of payment modifier that will be used alongside of, instead of replacing, the GP and GO therapy modifiers, to identify the services furnished in whole or in part by PTAs or OTAs that will be tied to the reduced payment for the respective PT or OT discipline in CY 2022. By using the new modifiers for therapy assistants as payment modifiers, rather than therapy modifiers, services furnished by PTAs and OTAs will continue to be captured by the GP and GO therapy modifiers, as they are now, when delivered under the an outpatient PT or OT plan of care, respectively. We considered the commenters' requests not to use the two new modifiers for services furnished by PTAs and OTAs as therapy modifiers in addition to the current two therapy modifiers, GP and GO, respectively. We took into account their concerns about the reporting burden for both therapists and therapy assistants that would result if we were to double the number of therapy modifiers used to report the services delivered under PT and OT plans of care. We also considered the unintended consequences that could result from changing the long-standing nature of our three existing discipline-specific therapy modifiers used to report all services delivered under an outpatient plan of care for PT, OT, and SLP services. These consequences could be significant, especially since the existing modifiers are used by many other government payers and private insurers. Additionally, our claims processing systems have numerous edits tied to the therapy modifiers because these modifiers are used to track and accrue incurred costs of therapy services furnished under the outpatient therapy benefit by therapists and their assistants, as well as those services that physicians and NPPs furnish and bill as therapy services. Consequently, we agree with commenters that it is preferable to use the two new modifiers as payment modifiers to identify the services furnished in whole or in part by therapy assistants, instead of changing the overall configuration of our therapy modifiers established through CY 1998 rulemaking and designed to track services to the then therapy cap amounts for outpatient therapy services furnished under PT, OT, and SLP plans of care.
This approach—using payment modifiers rather than therapy modifiers—necessitates revisions to the descriptors we proposed for the new therapy assistant modifiers. As therapy modifiers, the new modifiers were proposed to define the PTA or OTA services delivered under an outpatient PT or OT plan of care, respectively. Modifying our proposal to instead use the two new modifiers as payment modifiers, we are removing references to the services being delivered under an outpatient PT or OT plan of care because the plan is specific to the GP and GO therapy modifiers. We also retained the terminology of “in whole or in part” as part of the definition of these therapy assistant payment modifiers, as specified at section 1834(v) of the Act, and clarified the therapy assistants' services are included as part of the corresponding PT or OT discipline. As a result, we are finalizing the two new payment modifiers to identify services furnished in whole or in part by a PTA and OTA, modifiers CQ and CO (C, capital letter O), respectively as follows.
•
•
Because we are establishing the two new modifiers for the services furnished in whole or in part by a PTA or OTA as payment modifiers instead of as therapy modifiers, it is no longer necessary to revise the existing GP, GO, and GN therapy modifiers as we initially proposed to differentiate which professionals may furnish services using the GP, GO, and GN therapy modifiers in the absence of therapy modifiers used
• GP—services delivered under an outpatient physical therapy plan of care.
• GO—services delivered under an outpatient occupational therapy plan of care.
• GN—services delivered under an outpatient speech-language pathology plan of care.
As part of the proposed rule, we noted that therapy assistants are precluded from furnishing outpatient therapy services incident to the services of a physician or NPP, and as such, the new PTA and OTA modifiers cannot be used on the line of service of the professional claim when the rendering NPI identified on the claim is a physician or an NPP. This is because PTAs and OTAs don't meet the qualifications of a physical or occupational therapist that is set forth as conditions of payment in the regulatory provisions at §§ 410.59(a)(3)(iii) and 410.60(a)(3)(iii). We are clarifying that this payment policy applies similarly when the CQ and CO modifiers are used as payment modifiers. We plan to revise our manual provisions at Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, section 230, as appropriate, to reference the new CQ and CO modifiers that will be used to identify services furnished in whole or in part by a PTA or OTA starting in CY 2020.
Some commenters stated that documenting in the medical record the therapy services that are delivered in part by a therapy assistant will be burdensome for those services not fully or wholly furnished by an OTA or PTA, and some suggested that the reduced payment rates should only apply when the PTA or OTA furnishes the entire service.
Many commenters objected to our definition of “in part” and offered several alternatives. Some commenters suggested that we should not define when a PTA or OTA furnishes a service in whole or in part, but instead consider whether a therapist furnishes a service in whole or in part, stating that the PTA/OTA modifiers should not apply in cases where the therapist, not the assistant, furnishes the majority of the service.
Several commenters were concerned that applying the modifier when any minute of outpatient therapy is delivered by a therapy assistant has serious implications for beneficiary access to care and asked us to not finalize the definition of “in part” until CY 2020 rulemaking, when the new modifiers for services of therapy assistants are required on claims. The commenters stated that this delay would allow CMS additional time to engage in an extensive discussion with various external stakeholders in order to consider their input before CY 2020 rulemaking. Instead of waiting to define “in part” during CY 2020 rulemaking, one commenter suggested that we adopt a blended fee schedule rate for services furnished for more than 50 percent of the time by a therapist, including the services of both the 15-minute timed codes or untimed service-based codes, meaning that the rate paid would be 92.5 percent, halfway between 85 and 100 percent. Other commenters stated that the modifiers to identify services of PTAs and OTAs should not apply when the therapist fully furnished the services and the assistant merely lent a second pair of hands during the treatment for example, for safety reasons, such as where the patient is morbidly obese or has flaccid limb(s) and the completion of such services require more than one therapy professional.
Many commenters raised concerns about the application of our definition of “in part” when therapists and therapy assistants work together collaboratively. Some commenters raised concerns about applying the modifier for therapy assistant services when therapists and their assistants work interchangeably without a clear line between when the physical therapist might stop delivering treatment and the therapy assistant resumes treatment, and when the assistant acts as a second pair of hands to the therapist. Some commenters stated that when a therapist and assistant work together in a team-based approach, regardless of the amount of time the PTA or OTA contributes, that the new modifiers identifying services for application of the discounted payment rate should not apply. Some of these commenters requested that we exclude the use of new modifiers for therapy evaluations and re-evaluations because a therapy assistant is not permitted to fully furnish these services and these services require the therapist's clinical skill, judgment, and decision-making throughout. Others commenters requested that the modifiers should not apply for group therapy services, which are often provided collaboratively between the assistant and therapist because it is not fair to affix the discounted payment modifier to every patient in the group when a PTA or OTA furnishes one minute of the group service. Some commenters suggested we apply an 8-minute rule to the codes defined by 15-minute increments, stating that the modifiers should apply only when the PTA/OTA furnishes at least 8 minutes of the service, while other commenters asked us not to apply the assistant modifiers when these intervention services are furnished collaboratively by the therapist and
We do not agree with the commenters' suggestion that we define “in part” to mean a therapy service for which a PTA or OTA furnishes 50 percent or a majority of the service, or an otherwise substantial part of the service. The discounted payment rate specified under section 1834(v)(1) of the Act is required to be applied for services furnished “in whole or in part” by a therapy assistant. We do not believe “in whole or in part” means that the discounted payment rate would apply only to services for which 50 percent or more of the service was furnished by a therapy assistant.
In our review of section 1834(v)(1) of the Act, we believe that the phrase “in part” could be read to mean that if a therapy assistant participates only in a very small (so insubstantial as to not be meaningful) portion of the service, the discounted payment rate would not apply. In the proposed rule, we proposed that “in part” would not include the non-therapeutic portions of a service that could be performed by others without the training of PTAs or OTAs. Along those same lines, after further consideration of the public comments explaining the fluid nature of clinical practice between therapists and therapy assistants and the complexity of identifying and documenting when a service is furnished in part by a therapy assistant, we believe it would be appropriate to define a therapy assistant's participation in furnishing a therapy service “in part” to mean that the therapy assistant furnished more than a de minimis portion of the therapy service. Specifically, we believe it would be appropriate to specify that a therapy assistant is considered to furnish a therapy service “in part” when they perform more than 10 percent of the service. If, instead of specifying as we proposed that the modifiers are applicable when any minute of a therapeutic service is furnished by a PTA or OTA, we specified that the modifiers apply when more than 10 percent of a service is furnished by the therapy assistant, 1.5 minutes of a 15-minute unit could be furnished by the PTA or OTA without being subject to the discounted payment rate. If this 10 percent de minimis standard is applied to an untimed service, for example to a therapy evaluation for which the typical time is 45 minutes, the PTA or OTA could furnish up to 4.5 minutes of the service before the modifier and discounted payment rate would apply. We anticipate addressing applicability of the ten percent de minimis standard for other clinical scenarios in further rulemaking for CY 2020.
After consideration of the public comments, the following reflects a full summary of our finalized policies.
We are finalizing the establishment of two modifiers, one to identify services furnished in whole or in part by PTAs and the other to identify services furnished in whole or in part by OTAs. We are also finalizing our proposal to define PTAs and OTAs as those individuals meeting the personnel qualifications set forth in part 484.
Instead of finalizing the new modifiers to identify services furnished by PTAs and OTAs as therapy modifiers, we are adopting a final policy to use these new modifiers as a payment modifier that will be appended on the same line of service with the respective PT or OT therapy modifier. This modified approach necessitates revisions to the proposed descriptors of the new CQ and CO modifiers, and allows us to proceed without making the proposed revisions to the current descriptors for the three therapy modifiers—GP, GO and GN. We are finalizing the new payment modifiers as follows.
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We are not revising the three therapy modifiers as we had proposed. Instead, they will continue in effect, unmodified, as follows:
• GP—services delivered under an outpatient physical therapy plan of care.
• GO—services delivered under an outpatient occupational therapy plan of care.
• GN—services delivered under an outpatient speech-language pathology plan of care.
Instead of finalizing our proposed definition of a service that is furnished in whole or in part by a PTA or OTA as a service for which any minute of a therapeutic service is furnished by a PTA or OTA, we are finalizing a de minimis standard under which a service is furnished in whole or in part by a PTA or OTA when more than 10 percent of the service is furnished by the PTA or OTA. We anticipate addressing application of the therapy assistant modifiers and the 10 percent standard more specifically, including their application for different scenarios and types of services, in rulemaking for CY 2020.
Since January 1, 2013, all providers of outpatient therapy services, including PT, OT, and SLP services, have been required to include functional status information on claims for therapy services. In response to the Request for Information (RFI) on CMS Flexibilities and Efficiencies that was issued in the CY 2018 PFS proposed rule (82 FR 34172 through 34173), we received comments requesting burden reduction related to the functional reporting requirements that were adopted to implement section 3005(g) of the Middle Class Tax Relief and Jobs Creation Act (MCTRJCA) of 2012 (Pub. L. 112-96, January 1, 2013). More information about these requirements can be found in the CY 2019 PFS proposed rule (83 FR 35852).
We proposed to discontinue the functional reporting requirements for services furnished on or after January 1, 2019. Specifically, we proposed to amend our regulations by removing the following: (1) Conditions of payment at §§ 410.59(a)(4), 410.60(a)(4), 410.62(a)(4), and 410.105(d) that require claims for OT, PT, SLP, and Comprehensive Outpatient Rehabilitation Facility (CORF) PT, OT, and SLP services, respectively, to contain prescribed information on patient functional limitations; and, (2) the functional reporting-related phrase that requires the plan's goals to be consistent with functional information on the claim at § 410.61(c) for outpatient PT, OT, and SLP services and at § 410.105(c)(1)(ii) for the PT, OT, and SLP services in CORFs. In addition, we would (1) remove the functional reporting subregulatory requirements implemented primarily through Change Request 8005 last issued on December 21, 2012, via Transmittal 2622, (2) eliminate the functional reporting standard systems edits we have applied to claims, and (3) remove the functional reporting requirement provisions in our internet Only Manual (IOM) provisions including the Medicare Claims Processing Manual, Chapter 5 and the functional reporting requirements in Chapters 12 and 15 of the Medicare Benefits Policy Manual.
Our proposal would end the requirements for the reporting and documentation of functional limitation G-codes (HCPCS codes G8978 through G8999 and G9158 through G9186) and severity modifiers (in the range CH through CN) for outpatient therapy claims with dates of service on and after January 1, 2019. Accordingly, with the conclusion of our functional reporting system for dates of service after December 31, 2018, we proposed to delete the applicable non-payable HCPCS G-codes specifically developed to implement that system through the CY 2013 PFS final rule with comment period (77 FR 68598 through 68978).
We sought comment on these proposals. The following is a summary of the comments we received on these proposals.
After consideration of the public comments, we are finalizing our proposed changes to discontinue the functional reporting requirements for outpatient therapy services furnished on or after January 1, 2019. Specifically, we are removing the following regulatory requirements: (1) Conditions of payment at §§ 410.59(a)(4), 410.60(a)(4), 410.62(a)(4), and 410.105(d) that require claims for OT, PT, SLP, and Comprehensive Outpatient Rehabilitation Facility (CORF) PT, OT, and SLP services, respectively, to contain prescribed information on patient functional limitations; and, (2) the functional reporting-related phrase that requires the plan's goals to be consistent with functional information on the claim at § 410.61(c) for outpatient PT, OT, and SLP services and at § 410.105(c)(1)(ii) for the PT, OT, and SLP services in CORFs.
In addition to amending these regulations, we are ending the requirements for the reporting and documentation of functional limitation G-codes (HCPCS codes G8978 through G8999 and G9158 through G9186) and severity modifiers (in the range CH through CN) for outpatient therapy claims with dates of service on and after January 1, 2019.
Instead of deleting the HCPCS G-codes effective for CY 2019 as proposed, we are finalizing a modification of that proposal to retain the set of 42 non-payable HCPCS G-codes until CY 2020 as this will allow time for therapy providers and other private insurers who currently use these HCPCS G-codes for purposes of functional reporting to update their billing systems and policies. This will avoid a situation where claims that inadvertently contain any of these G-codes during CY 2019 can be processed, and are not unnecessarily returned or rejected. The retention of HCPCS G-codes through CY 2019 will also allow physical and occupational therapists to report six of these non-payable HCPCS G-codes and the measures developed from them for purposes of meeting the MIPS program requirements which are found in section III.I.3. of this final rule.
We also intend to revise our manuals regarding the application of the functional reporting requirements in our IOM, Pub. 100-02, Medicare Benefits Policy Manual, Chapters 12 and 15, and Pub. 100-04, Medicare Claims Processing Manual, Chapter 5.
As noted above in this section, the KX modifier thresholds were established through section 50202 of the Bipartisan Budget Act of 2018. These KX modifier thresholds were formerly referred to as therapy caps and are a permanent provision of the law, meaning that the statute does not specify an end date. These per-beneficiary amounts under section 1833(g) of the Act (as amended by section 4541 of the Balanced Budget Act of 1997) (Pub. L. 105-33, August 5, 1997) are updated each year based on the MEI. Specifically, these amounts are calculated by updating the previous year's amount by the MEI for the upcoming calendar year and rounding to the nearest $10.00. Increasing the CY 2018 KX modifier threshold amount of $2,010 by the CY 2019 MEI of 1.5 percent and rounding to the nearest $10.00 results in a CY 2019 KX threshold amount of $2,040 for PT and SLP services combined and $2,040 for OT services.
Along with the KX modifier thresholds, section 50202 of the Bipartisan Budget Act of 2018 also added section 1833(g)(7)(B) of the Act which retains the targeted medical review process, but at a lower threshold amount of $3,000 (until CY 2028) as detailed previously in this section. For CY 2018, the MR threshold is $3,000 for PT and SLP services combined and $3,000 for OT services. Under the established targeted review process, some, but not all claims exceeding the MR threshold amount are subject to review. For information on the targeted manual medical review process, go to
CMS tracks each beneficiary's incurred expenses for therapy services annually and counts them toward the KX modifier and MR thresholds by applying the PFS rate for each service less any applicable multiple procedure payment reduction (MPPR) amount for services of CMS-designated “always therapy” services.
As required by section 1833(g)(6)(B) of the Act, added by section 603(b) of the American Taxpayer Relief Act of 2012 (ATRA) (Pub. L. 112-240, January 2, 2013) and extended by subsequent legislation, including section 50202 of the Bipartisan Budget Act of 2018, the PFS-rate accrual process is applied to outpatient therapy services furnished by critical access hospitals (CAHs) even though they may be paid on a cost basis (effective January 1, 2014).
For Maryland hospitals paid under the Maryland All-Payer Model, currently being tested under the authority of section 1115A of the Act (effective January 1, 2016), we use the submitted charge amounts to accrue to the KX modifier and MR thresholds.
After expenses incurred for the beneficiary's outpatient therapy services for the year have exceeded one or both of the KX modifier thresholds, therapy suppliers and providers use the KX modifier on claims for subsequent medically necessary services. By using the KX modifier, the therapist is attesting that the services above the KX modifier thresholds are reasonable and necessary and that there is documentation of medical necessity for the services in the beneficiary's medical record. Claims for outpatient therapy services that exceed the KX modifier thresholds but do not include the KX modifier are denied.
Consistent with statutory provisions in section 1847A of the Act, many current Medicare Fee-For-Service (FFS) payments for separately payable drugs and biologicals furnished by providers and suppliers include an add-on set at 6 percent of the volume-weighted average sales price (ASP) or wholesale acquisition cost (WAC) for the drug or biological (the “6 percent add-on”). Although section 1847A of the Act does not specifically state what the 6 percent add-on represents, it is widely believed to include services associated with drug acquisition that are not separately paid for, such as handling, storage, other overhead, as well as additional mark-
Although the add-on percentage for drug payments made under section 1847A of the Act is typically applied to the ASP, a 6 percent add-on is also applied to the WAC to determine the Part B drug payment allowances in the following situations. First, for single source drugs, as authorized in section 1847A(b)(4) of the Act, payment is made using the lesser of ASP or WAC; and section 1847A(b)(1) of the Act requires that a 6 percent add-on be applied regardless of whether WAC or ASP is less. Second, for drugs and biologicals where the ASP during first quarter of sales is unavailable, section 1847A(c)(4) of the Act allows the Secretary to determine the payment amount for the drug or biological based on the WAC or payment methodologies in effect on November 1, 2003. We note that this provision does not specify that an add-on percentage be applied if WAC-based payment is used, nor is an add-on percentage specified in the implementing regulations at § 414.904(e)(4). The application of the add-on percentage to WAC-based payments during a period where partial quarter ASP data was available was discussed in the 2011 PFS final rule with comment (75 FR 73465 through 73466). Third, in situations where Medicare Administrative Contractors (MACs) determine pricing for drugs that do not appear on the ASP pricing files and for new drugs, WAC-based payment amounts may also be used, as discussed in Chapter 17, Section 20.1.3 of the Medicare Claims Processing Manual. This section of the manual describes the use of a 6 percent add-on.
The incorporation of discounts in the determination of payment amounts made for Part B drug varies. Most Part B drug payments are based on the drug's or biological's ASP; as provided in section 1847A(c)(3) of the Act, the ASP is net of many discounts such as volume discounts, prompt pay discounts, cash discounts, free goods that are contingent on any purchase, chargebacks, and rebates (other than rebates under Medicaid drug rebate program). In contrast, the WAC of a drug or biological is defined in section 1847A(c)(6)(B) of the Act as the manufacturer's list price for the drug or biological to wholesalers or direct purchasers in the United States, not including prompt pay or other discounts, rebates or reductions in price, for the most recent month for which the information is available, as reported in wholesale price guides or other publications of drug or biological pricing data. Because the WAC does not include discounts, it typically exceeds ASP, and the use of a WAC-based payment amount for the same drug results in higher dollar payments than the use of an ASP-based payment amount.
Although discussions about the add-on tend to focus on ASP-based payments (because ASP-based payments are more common than WAC-based payments), the add-on for WAC-based payments has also been raised in the June 2017 MedPAC Report to the Congress (
In the case of a drug or biological during an initial sales period in which data on the prices for sales for the drug or biological is not sufficiently available from the manufacturer, section 1847A(c)(4) of the Act permits the Secretary to make payments that are based on WAC. In other words, although payments under this section may be based on WAC, unlike section 1847A(b) of the Act (which specifies that certain payments must be made with a 6 percent add-on), section 1847A(c)(4) of the Act does not require that a particular add-on amount or percentage be applied to partial quarter WAC-based pricing. Consistent with section 1847A(c)(4) of the Act, we proposed that effective January 1, 2019, WAC based payments for Part B drugs made under section 1847A(c)(4) of the Act, utilize a 3 percent add-on in place of the 6 percent add-on that is currently being used. We proposed a 3 percent add-on because this percentage is consistent with MedPAC's analysis and recommendations discussed in the paragraph above and cited in its June 2017 Report to the Congress. Although other approaches for modifying the add-on amount, such as a flat fee, or percentages that vary with the cost of a drug, are possible, we proposed a fixed percentage in order to be consistent with other provisions in section 1847A of the Act that specify fixed add-on percentages of 6 percent (section 1847A(b) of the Act) or 3 percent (section 1847A(d)(3)(C) of the Act). A fixed percentage is also administratively simple to implement and administer, predictable, and easy for manufacturers, providers and the public to understand.
We have also reviewed corresponding regulation text at § 414.904(e)(4). To conform the regulation text more closely to the statutory language at section
We also discussed changing the policy articulated in the Medicare Claims Processing Manual that describes the application of the 6 percent add-on to payment determinations made by MACs for new drugs and biologicals. Chapter 17 section 20.1.3 of the Claims Processing Manual (
We note that the PFS rule proposals do not include WAC-based payments for single source drugs under section 1847A(b) of the Act, that is, where the statute specifies that the payment limit is 106 percent of the lesser of ASP or WAC.
We have stated in previous rulemaking (80 FR 71101) that it is desirable to have fair reimbursement in a healthy marketplace that encourages product development. We have also stated that we seek to promote innovation to provide more options to patients and physicians, and competition to drive prices down (82 FR 53183). These positions have not changed. However, since 2011, concern about the impact of drug pricing and spending on Part B drugs has continued to grow. From 2011 to 2016, Medicare Part B drug spending increased from $17.6 billion to $28.0 billion, representing a compound annual growth rate of 9.8 percent, with per capita spending increasing 54 percent, from $532 to $818 (Based on Spending and Enrollment Data from the CMS Office of Enterprise Data and Analytics). These increases affect the spending by Medicare and beneficiary out-of-pocket costs. In the context of these concerns, we believe that implementation of these proposals would improve Medicare payment rates by better aligning payments with drug acquisition costs, especially for the growing number of drugs with high annual spending and high launch prices where single doses can cost tens or even hundreds of thousands of dollars. The proposals would also decrease beneficiary cost sharing. A 3 percentage point reduction in the total payment allowance will reduce a patient's 20 percent Medicare Part B copayment—for a drug that costs many thousands of dollars per dose, this can result in significant savings to an individual. The proposed approach would help Medicare beneficiaries afford to pay for new drugs by reducing out of pocket expenses and would help counteract the effects of increasing launch prices for newly approved drugs and biologicals. Finally, the proposals are consistent with recent MedPAC recommendations.
The following is a summary of the comments we received on these proposals.
If the add-on is intended to account for administrative complexity, handling, storage and other overhead costs, these factors are not considered to be exactly proportional to current drug prices (
Many new drugs are expensive; single doses may cost thousands of dollars. Six percent add-ons for expensive drugs may be excessive relative to factors such as the cost to acquire a drug, handling and storage, and other overhead costs. We believe that overhead costs for most new drugs and biologicals are generally comparable to the overhead costs for most other injectable Part B drugs. For example, many heavily utilized injectable Part B drugs and biologicals, including new products, appear to be readily available since they are listed in drug wholesalers' catalogues. With certain exceptions, such as biologicals made from autologous cells, prescribing information indicates that many injectable Part B drugs and biologicals are stable under refrigeration or room temperature and do not require highly specialized storage or shipping conditions. We also note that many newer injectable drugs are also produced in ready to use liquid form, thus additional reconstitution and complicated dose preparation steps are not necessary. For many newer injectable products that were added to the ASP drug files in 2018, prescribing information indicates that dose preparation is comparable to many other sterile injectables and consists of drawing up the drug into a syringe using aseptic technique, and sometimes diluting the dose in a small volume bag of intravenous fluid. Some of the newer products are available in ready to use syringes which are administered directly to the patient with no special preparation steps.
We believe that the 3 percent reduction will help encourage the appropriate utilization of new drugs by lessening the financial incentive to overutilize drugs during their initial period of sales. We will discuss the percentage in more detail in the next comment response, but in general we believe that this reduction will not reduce margins for Part B drugs to an extent that would significantly and negatively affect providers, for several reasons. First, the overhead for many new drugs and biologicals is not likely to be significantly higher than the overhead for existing Part B injectable drugs (as discussed in the paragraph above). Second, the add-on is based on an undiscounted list price that is usually higher than market prices, and many new drugs and biologicals are costly. When the add-on is based on an undiscounted list price, this may contribute to potentially excessive add-on payments, particularly for expensive new drugs. As the WAC of a drug increases, so does the dollar value of the add-on, and this increase is not tied to any other factors, such actual market cost, administrative complexity of ordering the drug, or additional overhead costs, for example. The add-on for a costly drug can add significantly to the payment for a drug; a 6 percent add-on for a $5,000 dose of a drug is $300, while the 6 percent add-on for a $10,000 dose is $600. Third, the duration of the reduction to WAC-based payments for new drugs would be brief, applying only during an initial period as stipulated in section 1847A(c)(4) of the Act, where ASP data for drugs or biologicals (including biosimilars) is not sufficiently available to determine an ASP-based payment. Fourth, based on recent additions to the ASP drug pricing files, the change would affect only a small number of drugs each year. Typically, several drugs are added to the ASP Drug Pricing files each quarter, and not all of those drugs are priced based on WAC; some are added to the pricing files after the initial period of sales and are paid based on ASP. For these reasons, we are not persuaded that the reduction of the add-on for new drugs would have significant impact on margins for most physicians or other providers, including small and rural practices.
While some WAC based payments for new drugs could be less than ASP-based payments, the WAC exceeds the ASP for most new drugs entering the market. Our approach using a percentage of the WAC-based amount provides an administratively simple and straightforward solution for new Part B drugs.
We reiterate that our proposal did not include payments for single source drugs under section 1847A(b)(4) of the Act, where payment is made using the lesser of ASP or WAC. (This methodology applies after CMS receives ASP data for the drug.) Section 1847A(b)(1) of the Act requires that a 6 percent add-on be applied regardless of whether WAC or ASP is less; legislation would be required to change the percentage of the add-on that is specified in this provision.
Although the number of new drugs that appear on the ASP Drug Pricing Files with a WAC-based payment amount is limited, we stated in the proposed rule (83 FR 36047) that the average difference between WAC and ASP-based payment limits for a group of 3 recently approved drugs and biologicals that appeared on the ASP Drug Pricing Files (including one biosimilar biological product) was 9.0 percent. Excluding the biosimilar biological product results in a difference of 3.5 percent. These findings agree with the MedPAC's analysis and support the use of a 3 percent reduction to WAC-based payments for new drugs. Given the limited application of this policy change, the sources used by the MedPAC (which include industry statements), and our internal review, we do not believe that additional study or delay is necessary.
We are aware that ASP-based payments may exceed payments based on WAC if the percentage for the WAC add-on is smaller than the ASP add-on. The proposal for this policy change was limited to payments under section 1847A(c)(4) of the Act. We do not have authority to change the add-on for WAC based payments made under section 1847A(b)(4) of the Act or payments based on the ASP, and we have not addressed such payments in this rule. We believe that implementation of this relatively minor change without further delay is a positive step toward addressing high drug prices, including list prices. We acknowledge that manufacturers may increase Part B drug prices and that price increases could apply to both list prices like WAC and market-based prices, such as ASP. Section 1847A of the Act does not provide us with authority to addresses most increases for Part B drug prices (we have limited authority to substitute AMP-based prices for ASP, and authority to use alternative prices in response to certain public health emergencies). Price increases from manufacturers and other sources that add to high drug costs will be considered as we continue our work to address concerns about high drug prices.
In contrast, several commenters agreed that cost sharing could drop, though the effect would be transient (limited to the early phase of a drug's marketing). However, these commenters generally agree that the CMS proposal was a step in the right direction for addressing the high cost of drugs.
After considering the comments submitted in response to our proposal, consistent with section 1847A(c)(4) of the Act, we are finalizing our proposal to reduce the add-on percentage for WAC based payments for new drugs. Effective January 1, 2019, WAC based payments for new Part B drugs made under section 1847A(c)(4) of the Act, will utilize a 3 percent add-on in place of the 6 percent add-on that is currently being used. Our final policy is consistent with the President's Budget and affects an area where we have flexibility to make a change through regulation. The percentage reduction is also consistent with the MedPAC's analysis and recommendations discussed in this section and cited in its June 2017 Report to the Congress. A fixed percentage is also administratively simple to implement and administer, is predictable, and is easy for manufacturers, providers and the public to understand. We believe that the 3 percent reduction to the add-on for WAC-based payments will create greater parity overall between WAC and ASP for new drugs, biologicals and biosimilars and continue to encourage appropriate utilization of drugs. We are not persuaded that this modest and brief reduction in payments will impair access to new drugs or shift patient care to other settings.
This change does not apply to single source drugs or biologicals paid under section 1847A(b)(4) of the Act where payment is made using the lesser of ASP or WAC; section 1847A(b)(1) of the Act requires that a 6 percent add-on be applied regardless of whether WAC or ASP is less.
We are clarifying that changes to payments for WAC based drugs discussed in this rule apply only to new drugs and only during the time period while an ASP-based payment limit is not available. This time period begins when a drug is marketed and no ASP data is available for the manufacturer to report to us and ends at the end of the partial quarter pricing period when partial quarter ASP data becomes available to us. We will provide additional guidance or program instructions as appropriate.
The variable percentage that we plan to utilize in the manual, that is, the use of an add-on that is up to 3 percent, addresses the wide range of Part B drug prices. As discussed earlier in this section, the 6 percent add-on payment amount for very expensive drugs can result in very high add-on payments. For example, 6 percent of a $30,000 drug is $1800, while 6 percent of $300,000 is $18,000. We are aware of recently approved Part B drugs that have per dose price points up to several hundred thousand dollars. Our intent is to address the add-on payment that is associated with new drugs before national pricing and potentially other related policies, such as coverage, are developed. Our approach is consistent with provisions in section 1847A(c)(4) of the Act, which does not set a specific percentage for the add-on for drugs where ASP is not available. We also note that section 1847A(c)(5) of the Act provides authority to issue program instructions to implement section 1847A of the Act.
In addition to the comments on the Part B drug add-on percentage for certain drugs discussed previously in this section, we received comments that suggested other alterations to the payment methodology under section 1847A of the Act. These suggestions include replacing a percentage add-on with a flat fee, changes to WAC-based pricing for drugs that are not new, changing payments for drugs that are not paid for under section 1847A of the Act (such as radiopharmaceuticals used in the office), the use of competitive acquisition or value-based payment for Part B drugs, making direct pricing interventions with manufacturers, requiring greater transparency for drug pricing, and educating (or otherwise influencing) providers about Part B drug prescribing. We also received comments pertaining to ASP reporting by manufacturers. Several commenters also questioned the authority for Part B drug payment reductions associated with the sequester. Comments on these issues are also outside the scope of this rule. Therefore, these comments are not addressed in this final rule.
Section 3(a) of the Patient Access and Medicare Protection Act (PAMPA) (Pub. L. 114-115, enacted December 28, 2015) revised section 1848 of the Act so that, for the fee schedule established under section 1848(b) of the Act in 2017 and 2018, we must apply the same code definitions and work RVUs under section 1848(c)(2)(C)(ii) of the Act, and the same direct inputs for the PE RVUs for radiation treatment delivery and related imaging services under section 1848(c)(2)(C)(ii) of the Act as those definitions, units, and inputs for such services for the fee schedule established for services furnished in 2016. Section 51009 of the Bipartisan Budget Act of
For the Report to Congress, the CMS Center for Medicare and Medicaid Innovation (Innovation Center) conducted an environmental scan of current evidence, as well as held a public listening session followed by an opportunity for RT stakeholders to submit written comments about a potential APM. A review of the applicable evidence in the Report to Congress demonstrated that episode payment models can be a tool for improving care and reducing expenditures. We believe that radiation oncology is a promising area of health care for bundled payments, in part, based on the findings in the Report to Congress. The CMS Innovation Center has and will continue to use public information regarding commercial initiatives, as well as stakeholder feedback to help inform the development, implementation, and refinement of design and testing of a potential model that tests payment for RT services under the authority of section 1115A of the Act.
Prior to January 1, 2018, Medicare paid for clinical diagnostic laboratory tests (CDLTs) on the Clinical Laboratory Fee Schedule (CLFS) under sections 1832, 1833(a), (b), and (h), and 1861 of the Social Security Act (the Act). Under the previous methodology, CDLTs were paid based on the lesser of: (1) The amount billed; (2) the local fee schedule amount established by the Medicare Administrative Contractor (MAC); or (3) a national limitation amount (NLA), which is a percentage of the median of all the local fee schedule amounts (or 100 percent of the median for new tests furnished on or after January 1, 2001). In practice, most tests were paid at the NLA. Under the previous system, the CLFS amounts were updated for inflation based on the percentage change in the Consumer Price Index for All Urban Consumers (CPI-U), and reduced by a multi-factor productivity adjustment and other statutory adjustments, but were not otherwise updated or changed.
Section 1834A of the Act, as established by section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA), required significant changes to how Medicare pays for CDLTs under the CLFS. The CLFS final rule, entitled Medicare Clinical Diagnostic Laboratory Tests Payment System (CLFS final rule), published in the
The first data collection period, for which applicable information was collected, occurred from January 1, 2016 through June 30, 2016. The first data reporting period, during which reporting entities reported applicable information to CMS, occurred January 1, 2017 through March 31, 2017. On March 30, 2017, we announced a 60-day enforcement discretion period of the assessment of civil monetary penalties (CMPs) for reporting entities that failed to report applicable information. Additional information about the 60-day enforcement discretion period is available on the CMS website at
In general, the payment amount for each CDLT on the CLFS furnished beginning January 1, 2018, is based on the applicable information collected during the data collection period and reported to us during the data reporting period, and is equal to the weighted median of the private payor rates for the test. The weighted median is calculated by arraying the distribution of all private payor rates, weighted by the volume for each payor and each laboratory. The payment amounts established under the CLFS are not subject to any other adjustment, such as geographic, budget neutrality, or annual update, as required by section 1834A(b)(4)(B) of the Act. Additionally, section 1834A(b)(3) of the Act, implemented at § 414.507(d), provides a phase-in of payment reductions, limiting the amounts the CLFS rates for each CDLT (that is not a new ADLT or new CDLT) can be reduced as compared to the payment rates for the preceding year. For the first 3 years after implementation (CY 2018 through CY 2020), the reduction cannot be more than 10 percent per year, and for the next 3 years (CY 2021 through CY 2023), the reduction cannot be more than 15 percent per year. For most CDLTs, the data collection period, data reporting period, and payment rate update occur every 3 years. As such, the next data collection period for most CDLTs will be January 1, 2019 through June 30, 2019, and the next data reporting period will be January 1, 2020 through March 31, 2020, with the next update to CLFS occurring on January 1, 2021. Additional information on the private payor rate-based CLFS is detailed in the CLFS final rule (81 FR 41036 through 41101).
As we discussed in the CY 2019 PFS proposed rule (83 FR 35856), after the initial data collection and data reporting periods, we received feedback on a range of topics related to the private payor rate-based CLFS. Some commenters expressed concern that the
We noted in the proposed rule that, in determining payment rates under the private payor rate-based CLFS, one of our objectives is to obtain as much applicable information as possible from the broadest possible representation of the national laboratory market on which to base CLFS payment amounts, for example, from independent laboratories, hospital outreach laboratories, and physician office laboratories, without imposing undue burden on those entities. As we noted throughout the CLFS final rule, we believe it is important to achieve a balance between collecting sufficient data to calculate a weighted median that appropriately reflects the private market rate for a CDLT, and minimizing the reporting burden for entities. In response to this feedback and in the interest of facilitating our goal, we proposed a change to the Medicare CLFS for CY 2019 in section III.A. of the CY 2019 PFS proposed rule. We stated that we believe this proposal may result in more data being used on which to base CLFS payment rates.
In addition to this proposal, we solicited public comments on other approaches that have been requested by some stakeholders who suggested that such approaches would result in CMS receiving even more applicable information to use in establishing CLFS payment rates. The approaches include revising the definition of applicable laboratory and changing the low expenditure threshold. These topics are discussed in this section.
In order for a laboratory to meet the majority of Medicare revenues threshold, section 1834A(a)(2) of the Act requires that, “with respect to its revenues under this title, a majority of such revenues are from” the CLFS and the PFS in a data collection period. In the CLFS final rule, we stated that “revenues under this title” are payments received from the Medicare program, which includes fee-for-service payments under Medicare Parts A and B, as well as Medicare Advantage (MA) payments under Medicare Part C, and prescription drug payments under Medicare Part D, and any associated Medicare beneficiary deductible or coinsurance amounts for Medicare services furnished during the data collection period (81 FR 41043). This total Medicare revenues amount (the denominator in the majority of Medicare revenues threshold calculation) is compared to the total of Medicare revenues received from the CLFS and/or PFS (the numerator in the majority of Medicare revenues threshold calculation). If the numerator is greater than 50 percent of the denominator for a data collection period, the entity has met the majority of Medicare revenues threshold criterion. We reflected that requirement in § 414.502 in the third paragraph of the definition of applicable laboratory.
As we explained in the CY 2019 PFS proposed rule, we have considered that our current interpretation of total Medicare revenues may have the effect of excluding laboratories that furnish Medicare services to a significant number of beneficiaries enrolled in MA plans under Medicare Part C from meeting the majority of Medicare revenues threshold criterion, and therefore, from qualifying as applicable laboratories. For instance, if a laboratory has a significant enough Part C component so that it is receiving greater than 50 percent of its total Medicare revenues from MA payments under Part C, it would not meet the majority of Medicare revenues threshold because its revenues derived from the CLFS and/or PFS would not constitute a majority of its total Medicare revenues. We stated that we believe if we were to exclude MA plan revenues from total Medicare revenues, more laboratories of all types may meet the majority of Medicare revenues threshold, and therefore, the definition of applicable laboratory, because it would have the effect of decreasing the amount of total Medicare revenues and increase the likelihood that a laboratory's CLFS and PFS revenues would constitute a majority of its Medicare revenues.
We stated in the proposed rule that we believe section 1834A of the Act permits an interpretation that MA plan payments to laboratories not be included in the total Medicare revenues component of the majority of Medicare revenues threshold calculation. Rather, MA plan payments to laboratories can be considered to only be private payor payments under the CLFS. We emphasized in the CY 2019 PFS proposed rule that this characterization of MA plan payments is limited to only the CLFS for purposes of defining applicable laboratory. Whether MA plan payments to laboratories or other entities are considered Medicare “revenues” or “private payor payments” in other contexts in the Medicare program is not relevant to our proposal, and our characterization of MA plan payments as private payor payments for purposes of the CLFS has no bearing on any aspect of the Medicare program other than the CLFS.
As noted above, we defined total Medicare revenues for purposes of the majority of Medicare revenues threshold calculation to include fee-for-service payments under Medicare Parts A and B, as well as MA payments under Medicare Part C, prescription drug payments under Medicare Part D, and any associated Medicare beneficiary deductible or coinsurance amounts for Medicare services furnished during the data collection period. However, section 1834A(a)(8) of the Act, which defines the term “private payor,” identifies at section 1834A(a)(8)(B) a “Medicare Advantage plan under Part C” as a type of private payor. Under the private payor rate-based CLFS, CLFS payment amounts are based on private payor rates that are reported to CMS. Accordingly, an applicable laboratory that receives MA plan payments is to consider those MA plan payments in identifying its applicable information, which must be reported to CMS. We explained in the proposed rule that we believe it is more logical to not consider MA plan payments under Part C to be both Medicare revenues for determining applicable laboratory status and private payor rates for purposes of reporting applicable information. Congress contemplated that applicable laboratories would furnish MA services, as reflected in the requirement that private payor rates must be reported for MA services. However, under our current definition of applicable laboratory, laboratories that furnish MA services, particularly those that furnish a significant amount, are less likely to meet the majority of Medicare revenues threshold, which means they would be less likely to qualify as applicable laboratories, and as a result, to report private payor rates for MA services.
Therefore, we stated in the proposed rule that after further review and consideration of the new private payor rate-based CLFS, we believe it is appropriate to include MA plan revenues as only private payor payments rather than both Medicare revenues, for the purpose of
For these reasons, we proposed that MA plan payments under Part C would not be considered Medicare revenues for purposes of the applicable laboratory definition. We noted in the CY 2019 PFS proposed rule that if finalized, we would revise paragraph (3) of the definition of applicable laboratory at § 414.502 accordingly. We reiterated that not characterizing MA plan payments under Medicare Part C as Medicare revenues would be limited to the definition of applicable laboratory under the CLFS, and would not affect, reflect on, or otherwise have any bearing on any other aspect of the Medicare program.
In an effort to provide stakeholders a better understanding of the potential reporting burden that may result from this proposal, we provided a summary of the distribution of data reporting that occurred for the first data reporting period. We explained that if we were to finalize the proposed change to the majority of Medicare revenues threshold component of the definition of applicable laboratory, additional laboratories of all types serving a significant population of beneficiaries enrolled in Medicare Part C could potentially qualify as applicable laboratories, in which case their data would be reported to us. As discussed in the proposed rule, we received over 4.9 million records from 1,942 applicable laboratories for the initial data reporting period, which we used to set CY 2018 CLFS rates. Additional analysis shows that the average number of records reported for an applicable laboratory was 2,573. The largest number of records reported for an applicable laboratory was 457,585 while the smallest amount was 1 record. A summary of the distribution of reported records from the first data collection period is illustrated in the Table 25.
Assuming a similar distribution of data reporting for the next data reporting period, the mid-point of reported records for an applicable laboratory would be approximately 300 (50th percentile for the first data reporting period was 294). However, as illustrated in Table 25, the number of records reported varies greatly, depending on the volume of services performed by a given laboratory. Laboratories with larger test volumes, for instance at the 90th percentile, should expect to report more records as compared to the midpoint used for this analysis. Likewise, laboratories with smaller test volume, for instance at the 10th percentile, should expect to report fewer records as compared to the midpoint.
The following is a summary of the comments we received and our responses to the comments regarding our proposal to modify the definition of applicable laboratory to exclude MA plan payments under Part C as Medicare revenues.
For the additional data reporting burden, as discussed in the Regulatory Impact Analysis in section VII. of the proposed rule (83 FR 36048), we estimated that excluding MA plan payments from total Medicare revenues (the denominator) of the majority of Medicare revenues threshold, and keeping the numerator constant (that is, revenues from only the CLFS and or PFS) yielded an increase of 49 percent in the number of laboratories meeting the majority of Medicare revenues threshold.
We also noted in the proposed rule that there would only be an associated impact to the Medicare rates to the extent the additional applicable laboratories are paid at a higher (or lower) private payor rate, as compared to other laboratories that reported previously
However, as we noted in the proposed rule, our proposal to exclude MA plan payments from total Medicare revenues responded directly to stakeholder concerns regarding the number of applicable laboratories reporting applicable information for the initial data reporting period. We believe that enabling more laboratories of all types that furnish testing to a significant Medicare Part C population to qualify as applicable laboratories and report data to CMS directly supports our goal of collecting as much applicable information as possible from the broadest representation of the national laboratory market on which to base CLFS payment amounts. Therefore, we believe receiving additional applicable information from more laboratories of all laboratory types outweighs the additional reporting burden on laboratories.
Given that section 1834A(a)(8)(B) of the Act specifically defines MA plans under Part C as private payors, and an applicable laboratory that receives MA plan payments must consider those MA plan payments in identifying its applicable information for reporting, we believe that it is more logical to consider MA plan payments only as private payor rates for purposes of reporting applicable information, rather than both private payor rates and Medicare revenues. We believe this is consistent with the statute and will help to increase laboratory participation from all types of laboratories. At the same time, we recognize the administrative concerns raised by some commenters regarding the data reporting requirements for laboratories with a significant Medicare Part C revenue component, particularly as some of these laboratories may be small physician offices or independent laboratories, which we have previously discussed as having a significant burden in reporting applicable information. However, as discussed previously in response to comments, we believe that modifying our definition of applicable laboratory so that we may receive applicable information from more laboratories that furnish tests to a significant Medicare Part C population, which are less likely to qualify for applicable laboratory status under the current policy, outweighs the additional reporting burden placed on these laboratories as well as directly supports our goal of collecting as much applicable information as possible from the broadest representation of the national laboratory market on which to base CLFS payment amounts. For these reasons we are finalizing our proposal to modify the definition of applicable laboratory to exclude MA plan revenues from total Medicare revenues (the denominator of the majority of Medicare revenues threshold). We are revising paragraph (3) of the definition of applicable laboratory at § 414.502 accordingly.
As discussed in the CY 2019 PFS proposed rule (83 FR 35858), and as noted previously, we define applicable laboratory at the NPI level, which means the laboratory's own billing NPI is used to identify a laboratory's revenues for purposes of determining whether it meets the majority of Medicare revenues threshold and the low expenditure threshold components of the applicable laboratory definition. For background purposes, the following summarizes some of the considerations we made in establishing this policy.
In the CLFS proposed rule, entitled Medicare Clinical Diagnostic Laboratory Tests Payment System, published in the October 1, 2015
Commenters who objected to our proposal to define applicable laboratory at the TIN level stated that our definition would exclude hospital laboratories because, in calculating the applicable laboratory's majority of Medicare revenues amount, which looks at the percentage of Medicare revenues from the PFS and CLFS across the entire TIN-level entity, virtually all hospital laboratories would not be considered an applicable laboratory. Many commenters expressed particular concern that our proposed definition would exclude hospital outreach laboratories, stating that hospital outreach laboratories, which do not provide laboratory services to hospital patients, are direct competitors of the broader independent laboratory market, and therefore, excluding them from the definition of applicable laboratory would result in incomplete and inappropriate applicable information, which would skew CLFS payment rates. Commenters maintained that CMS needed to ensure reporting by a broad scope of the laboratory market to meet what they viewed as the intent of the statute that all sectors of the laboratory market be included to establish accurate market-based rates (81 FR 41045).
In issuing the CLFS final rule, we found particularly compelling the comments that urged us to adopt a policy that would better enable hospital outreach laboratories to be applicable laboratories because we agreed hospital outreach laboratories should be included in determining the new CLFS payment rates. We believed it was important to facilitate reporting of private payor rates for hospital outreach laboratories to ensure a broader representation of the national laboratory
We also stated in the CLFS final rule that we believed the intent of the statute was to effectively exclude hospital laboratories as applicable laboratories, based on the statutory language, in particular, regarding the majority of Medicare revenues threshold criterion in section 1834A(a)(2) of the Act. Section 1834A(a)(2) of the Act provides that, to qualify as an applicable laboratory, an entity's revenues from the CLFS and the PFS need to constitute a majority of its total Medicare payments received from the Medicare program for a data collection period. What we found significant was that most hospital laboratories would not meet that majority of Medicare revenues threshold because their revenues under the Inpatient Prospective Payment System (IPPS) and Outpatient Prospective Payment System (OPPS) alone would likely far exceed the revenues they received under the CLFS and PFS. Therefore, we stated that we believe the statute intended to limit reporting primarily to independent laboratories and physician offices (81 FR 41045 through 41047). For a full discussion of the definition of applicable laboratory, see the CLFS final rule (81 FR 41041 through 41051).
As noted above, in response to public comments, we had previously finalized that an applicable laboratory is the NPI-level entity so that a hospital outreach laboratory assigned a unique NPI, separate from the hospital of which it is a part, is able to meet the definition of applicable laboratory and its applicable information can be used for CLFS rate-setting. We stated in the CY 2019 PFS proposed rule that we continue to believe that the NPI is the most effective mechanism for identifying Medicare revenues for purposes of determining applicable laboratory status and identifying private payor rates for purposes of reporting applicable information. Once a hospital outreach laboratory obtains its own unique billing NPI and bills for services using its own unique NPI, Medicare and private payor revenues are directly attributable to the hospital outreach laboratory. By defining applicable laboratory using the NPI, Medicare payments (for purposes of determining applicable laboratory status) and private payor rates and the associated volume of CDLTs can be more easily identified and reported to us. We also noted that we believe that finalizing our proposal to exclude MA plan payments under Medicare Part C from total Medicare revenues in the definition of applicable laboratory may increase the number of entities meeting the majority of Medicare revenues threshold, and therefore, allow them to qualify for applicable laboratory status. We stated that we believe that finalizing the change to the total Medicare revenues component of the applicable laboratory definition and our current policy that requires an entity to bill Medicare Part B under its own NPI, may increase the number of hospital outreach laboratories qualifying as applicable laboratories.
In addition, we noted that we are confident that our current policy supports our collecting sufficient applicable information in the next data reporting period, and that we received sufficient and reliable applicable information with which we set CY 2018 CLFS rates, and that those rates are accurate. We noted that we received applicable information from laboratories in every state, the District of Columbia, and Puerto Rico. This data included private payor rates for almost 248 million laboratory tests conducted by 1,942 applicable laboratories, with over 4 million records of applicable information. As we have noted, the largest laboratories dominate the market, and therefore, most significantly affect the payment weights (81 FR 41049). We stated that given that the largest laboratories reported their applicable information to CMS in the initial data reporting period, along with many smaller laboratories, we believe the data we used to calculate the CY 2018 CLFS rates was sufficient and resulted in accurate weighted medians of private payor rates.
However, we noted that we continue to consider refinements to our policies that could lead to including even more applicable information for the next data reporting period. Therefore, the comments and alternative approaches suggested by commenters, even though some were first raised prior to the CLFS final rule, were presented and offered for comment as part of the proposed rule.
Although an NPI-based definition of applicable laboratories includes more hospital outreach laboratories than a TIN-based definition, some commenters expressed concern that the NPI-based definition of applicable laboratory may not be sufficient to capture all of the hospital outreach laboratories. These commenters suggested we revise the definition specifically for the purpose of including more hospital outreach laboratories. Under a suggested approach, a laboratory could determine whether it meets the majority of Medicare revenues threshold and low expenditure threshold using only the revenues from services reported on the Form CMS-1450 (approved Office of Management and Budget number 0938-0997) 14x Type of Bill (TOB), which is used only by hospital outreach laboratories. The CMS-1450 14X TOB is the uniform bill (also known as the UB-04) for institutional providers that was approved by the National Uniform Billing Committee (NUBC)
The data elements referenced in the UB-04 manual are also used in the electronic claim standard as required by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Pub. L. 104-191, enacted August 21, 1996) as per of sections 1171 and 1172 of the Act. Consequently, there was additional emphasis placed on aligning the reporting instructions to closely mirror the HIPAA claim standard for institutional providers for both paper and electronic claims. The TOB is a required element on both the UB 04 and electronic equivalent of the 837I transaction of the HIPAA compliant 005010 standard transaction. The NUBC defines the 14X TOB as an outpatient hospital TOB, and it is used by hospitals to bill a payor for outreach laboratory services for non-patients. As discussed in Transmittal 3425, a non-patient is defined as a beneficiary who is neither an inpatient nor an outpatient of a hospital, but who has a specimen that is submitted for analysis to a hospital and the beneficiary is not physically present at the hospital for purposes of the laboratory service. All hospitals (including Critical Access Hospitals) bill non-patient laboratory tests on a TOB 14X. They are paid under the CLFS, and the Part B deductible and coinsurance do not apply. We believe that laboratory services billed on the CMS 1450 14X encompass all of the laboratory testing services.
To address this stakeholder's concern of including hospital outreach laboratories, we solicited public comments in the CY 2019 PFS on revising the definition of applicable laboratory to permit the revenues identified on the Form CMS-1450 14x
Although using the 14x TOB could alleviate some initial, albeit limited, administrative burden on hospital outreach laboratories to obtain a unique billing NPI, we explained that we would have operational and statutory authority concerns about defining applicable laboratory by the Form CMS-1450 14x TOB, as indicated below.
First, we explained that defining an applicable laboratory using the Form CMS-1450 14x TOB does not identify an entity the same way an NPI does. Whereas an NPI is associated with a provider or supplier to determine specific Medicare revenues, the 14x TOB is merely a billing mechanism that is currently used only for a limited set of services. Under an approach that permits laboratories to meet the majority of Medicare revenues threshold using the 14x TOB, private payor rates (and the volume of tests paid at those rates) would have to be identified that are associated with only the outreach laboratory services of a hospital's laboratory business. However, some private payors, such as MA plans, may not require hospital outreach laboratories to use the 14x TOB for their outreach laboratory services. To the extent a private payor does not require hospital outreach laboratory services to be billed on a 14x TOB (which specifically identifies outreach services), hospitals may need to develop their own mechanism for identifying and reporting only the applicable information associated with its hospital outreach laboratory services. In light of this possible scenario, we requested public comments about the utility of using the 14x TOB in the way we have described and on the level of administrative burden created if we defined applicable laboratory using the Form CMS-1450 14x TOB.
Second, we questioned whether hospitals would have sufficient time after publication of a new final rule that included using the Form CMS-1450 14x TOB, and any related subregulatory guidance, to develop and implement the information systems necessary to collect private payor rate data before the start of the next data collection period, that is, January 1, 2019. Therefore, we solicited public comments as to whether revising the definition of applicable laboratory to use the Form CMS-1450 14x TOB would allow laboratories sufficient time to make the necessary systems changes to identify applicable information before the start of the next data collection period.
Third, we noted that we believe defining applicable laboratory at the NPI level, as we currently do, provides flexibility for hospital outreach laboratories to not obtain a unique billing NPI, which may be burdensome, particularly where a hospital outreach laboratory performs relatively few outreach services under Medicare Part B. For example, under the current definition of applicable laboratory, if a hospital outreach laboratory's CLFS revenues in a data collection period are typically less than the low expenditure threshold, the hospital of which it is a part could choose not to obtain a separate NPI for its outreach laboratory and could thus avoid determining applicable laboratory status for its outreach laboratory component. In contrast, if laboratories were permitted to use the Form CMS-1450 14x TOB, revenues attributed to the hospital outreach laboratory would have to be calculated in every instance where those services exceeded the low expenditure threshold. This would be true even for a hospital outreach laboratory that performs relatively few outreach services under Medicare Part B. Therefore, we also solicited comments concerning this aspect of using the 14x TOB definition.
Fourth, and significantly, we stated that we believe that if we were to utilize such an approach in defining applicable laboratory, all hospital outreach laboratories would meet the majority of Medicare revenues threshold. We noted, at that time, we believed this approach would be inconsistent with the statute. By virtue of the majority of Medicare revenues threshold, the statute defines applicable laboratory in such a way that not all laboratories qualify as applicable laboratories. However, if we were to use the CMS-1450 14x TOB to define an applicable laboratory, all hospital outreach laboratories that use the 14x TOB would meet the majority of Medicare revenues threshold. Accordingly, we requested public comments regarding whether this definition would indeed be inconsistent with the statute, as well as comments that could identify circumstances under this definition whereby a hospital outreach laboratory would not meet the majority of Medicare revenues threshold.
The following is a summary of the comments we received and our responses to the comments regarding the use of the CMS-1450 14x TOB to define an applicable laboratory.
Another commenter stated their view that considerable burden is associated with requiring a hospital outreach laboratory to obtain its own NPI. According to this commenter, a hospital would need to re-credential under a new NPI with each of their payors in order to submit claims and receive payment from each of their payors for their hospital outreach laboratory services. This commenter stated that this process could take more than a year to complete. Accordingly, this commenter concluded that hospital outreach laboratories rarely obtain their own unique NPI (separate from the hospital) and it would not be practical to do so for the single purpose of reporting applicable information to CMS.
Additional commenters in support of refinements to the definition responded to CMS' concern that revenues attributed to the hospital outreach laboratory would have to be calculated in every instance where those services exceeded the low expenditure threshold, even for a hospital outreach laboratory that performs relatively few outreach services under Medicare Part
In contrast, several commenters strongly opposed the use of Form CMS-1450 14x TOB to define an applicable laboratory because of their views of the additional administrative burden for hospitals relative to the effect on CLFS rates. These commenters stated that even if every hospital outreach laboratory were to report private payor data, it is unlikely that it would result in a significant change to the weighted median of private payor rates due to the massive amount of data that would be reported by the large independent laboratories. They also agreed with the potential operational feasibility concerns we raised in the proposed rule.
We also considered the comments regarding the limited impact of this additional data to the weighted median of private payor rates. We believe that we will only know the impact of the data on CLFS rates by collecting data from hospital outreach laboratories. We believe inclusion of this information so that the CLFS rates better reflect the market outweighs the potential added burden on one segment of the market. However, if it becomes apparent that data from hospital outreach laboratories do not result in a significant change in the weighted median of private payor rates, we will revisit the use of the CMS-1450 14x TOB through future rulemaking.
In contrast, several stakeholders raised concerns about the implications this alternative approach would have on identifying applicable information for purposes of reporting that data to us. They stated that the Form CMS-1450 14x TOB will only capture Medicare Part B revenues, while private payor data would not be captured. In other words, the 14x TOB will correctly identify Medicare Part B revenues for purposes of determining applicable laboratory status, but that the hospital would be responsible for correctly identifying and collecting applicable information associated solely with the hospital outreach laboratory. Several commenters stated that billing systems for hospital outreach laboratories are not set up in a manner that allows this type of information to be easily extracted, and therefore, this approach to defining an applicable laboratory would pose a significant operational burden on hospitals.
Using the laboratory's own billing NPI as the basis for defining applicable laboratory, as we currently do, results in all independent laboratories meeting the statutory “majority of Medicare revenues” requirement because most, if not all, of an independent laboratory's Medicare revenues are received from the PFS and or CLFS. Similar to how the use of the NPI results in all independent laboratories meeting the majority of Medicare revenues threshold, using the Form CMS-1450 14x TOB as the basis for defining applicable laboratory would identify all hospital outreach laboratories that meet the statutorily required “majority of Medicare revenues” component of applicable laboratory.
We believe that the use of Form CMS-1450 14x TOB as a mechanism for applying the majority of Medicare revenues threshold identifies hospital outreach laboratories that meet this threshold, consistent with the statutory requirement for applicable laboratory status. We further believe that, absent having an NPI separate from the hospital, these hospital outreach laboratories otherwise would be excluded. We do not believe that the statute excludes laboratories that meet the majority of Medicare revenues threshold from potentially qualifying as an applicable laboratory. Therefore, using the 14x TOB to define applicable laboratory is consistent with the statute.
As stated above, accordingly, we are finalizing the use of the Form CMS-1450 14x TOB to define applicable laboratories, subject to other regulatory and subregulatory requirements, such as the regulatory low expenditure threshold.
In conclusion, as stated previously and for the reasons described previously, we are finalizing the use of the Form CMS-1450 14x TOB to define applicable laboratories, subject to other regulatory and subregulatory requirements, such as the regulatory low expenditure threshold.
We note that because of the low expenditure threshold, not all hospital outreach laboratories would meet the definition of an applicable laboratory and therefore not all hospital outreach laboratories would be required to report applicable information to us. In other words, hospital outreach laboratories
We believe that defining applicable laboratory by the NPI may be preferable to using the CMS-1450 14x TOB for some hospitals and so expect that some hospital outreach laboratories may still want to obtain their own billing NPI separate from the hospital. As such, they may do so and may qualify as an applicable laboratory in this manner. If so, they would report applicable information during the next data reporting period beginning January 1, 2020, through March 31, 2020.
We note that we utilize ongoing subregulatory guidance and provider education materials to provide more details regarding how applicable laboratories, both those identified through NPIs and hospital outreach laboratories identified through the combination of NPI and services reported using the 14x TOBs, are to report the applicable data to CMS. We also note that for hospitals which have an applicable laboratory, whether via its own NPI for its outreach laboratory or by identifying its status with the 14X TOB, the applicable laboratory would be required to report applicable information by March 31, 2020, for services reimbursed for the period between January 1, 2019, and June 30, 2019.
In conclusion, as stated previously, we are finalizing the use of the Form CMS-1450 14x TOB to define applicable laboratories. In other words, we are finalizing modification of the definition of applicable laboratory to also include 14X TOB revenues. We will also revise paragraph (2) of the definition of applicable laboratory at § 414.502 accordingly.
Some commenters requested that we use the CLIA certificate rather than the NPI to identify a laboratory that would be considered an applicable laboratory. We discussed in the CLFS proposed rule (80 FR 59392) why not all entities that meet the CLIA regulatory definition at § 493.2 would be applicable laboratories, and therefore, we did not propose to use the CLIA certificate as the mechanism for defining applicable laboratory. However, some commenters to the CLFS proposed rule suggested we use the CLIA certificate to identify the organizational entity that would be considered an applicable laboratory so that each entity that had a CLIA certificate would be an applicable laboratory (81 FR 41045). We considered those comments in the CLFS final rule and discussed why we chose not to adopt that approach.
Among other reasons, we explained in the CLFS final rule that we believed a CLIA certificate-based definition of applicable laboratory would be overly inclusive by including all hospital laboratories, as opposed to just hospital outreach laboratories. In addition, the CLIA certificate is used to certify that a laboratory meets applicable health and safety regulations in order to furnish laboratory services. Unlike, for example, the NPI, with which revenues for specific services can easily be identified, the CLIA certificate is not associated with Medicare billing and cannot be used to identify revenues for specific services. We also indicated that we did not know how a hospital would determine whether its laboratories would meet the majority of Medicare revenues threshold (and the low expenditure threshold) using the CLIA certificate as the basis for defining an applicable laboratory. In addition, we stated that, given the difficulties many hospitals would likely have in determining whether their laboratories are applicable laboratories, we also believed hospitals may object to using the CLIA certificate (81 FR 41045).
However, in light of stakeholders' suggestions to use the CLIA certificate to include hospital outreach laboratories in the definition of applicable laboratories, we solicited public comments on that approach. Under such an approach, the majority of Medicare revenues threshold and low expenditure threshold components of the definition of applicable laboratory would be determined at the CLIA certificate level instead of the NPI level. We explained that if we pursued such an approach, we would have to modify the definition of applicable laboratory in § 414.502 to indicate that an applicable laboratory is one that holds a CLIA certificate under § 493.2 of the chapter. We noted in the CY 2019 PFS proposed rule that we would have concerns, however, about defining applicable laboratory by the CLIA certificate.
First, we explained that as we discussed in the CLFS final rule, given that information regarding the CLIA certificate is not required on the Form CMS-1450 14x TOB, which is the billing form used by hospitals for their laboratory outreach services, it is not clear how a hospital would identify and distinguish revenues generated by its separately CLIA-certified laboratories for their outreach services. Therefore, we solicited public comments regarding the mechanisms a hospital would need to develop to identify revenues if we used the CLIA certificate for purposes of determining applicable laboratory status, as well as comments about the administrative burden associated with developing such mechanisms.
In addition, we understood there could be a scenario where one CLIA certificate is assigned to a hospital's entire laboratory business, which would include laboratory tests performed for hospital patients as well as non-patients (that is, patients who are not admitted inpatients or registered outpatients of the hospital). For example, hospital laboratories with an outreach laboratory component would be assigned a single CLIA certificate if the hospital outreach laboratory has the same mailing address or location as the hospital laboratory. We noted that in this scenario, the majority of Medicare revenues threshold would be applied to the entire hospital laboratory, not just its outreach laboratory component. If a single CLIA certificate is assigned to the hospital's entire laboratory business, the hospital laboratory would be unlikely to meet the majority of Medicare revenues threshold because its laboratory revenues under the IPPS and OPPS alone would likely far exceed the revenues it receives under the CLFS and PFS. As a result, a hospital outreach laboratory that could otherwise meet the definition of applicable laboratory, as currently defined at the NPI level, would not be an applicable laboratory if we were to require the CLIA certificate to define applicable laboratory. Given that this approach could have the effect of decreasing as opposed to increasing the number of applicable laboratories, we requested public comments on this potential drawback of defining applicable laboratory at the CLIA certificate level. We stated in the comment solicitation that feedback on this topic could help inform us regarding potential refinements to the definition of applicable laboratory, and that depending on the comments we receive, it is possible we would consider approaches described in that section. The following is a summary of the comments we received and our responses to the comments regarding the use of the CLIA certificate to define an applicable laboratory.
In the CLFS final rule, we established a low expenditure threshold component in the definition of applicable laboratory at § 414.502, which is reflected in paragraph (4). To be an applicable laboratory, at least $12,500 of an entity's Medicare revenues in a data collection period must be CLFS revenues (with the exception that there is no low expenditure threshold for an entity with respect to the ADLTs it furnishes). We established $12,500 as the low expenditure threshold because we believed it achieved a balance between collecting sufficient data to calculate a weighted median that appropriately reflects the private market rate for a test, and minimizing the reporting burden for laboratories that receive a relatively small amount of revenues under the CLFS. We indicated in the CLFS final rule (81 FR 41049) that once we obtained applicable information under the new payment system, we may decide to reevaluate the low expenditure threshold in future years and propose a different threshold amount through notice and comment rulemaking.
We explained in the CY 2019 PFS proposed rule that we recently heard from some laboratory stakeholders that the low expenditure threshold excludes most physician office laboratories and many small independent laboratories from reporting applicable information, and that by excluding so many laboratories, the payment rates under the new private payor rate-based CLFS reflect incomplete data, and therefore, inaccurate CLFS pricing.
As noted previously, we discussed in the CLFS final rule that we believed a $12,500 low expenditure threshold would reduce the reporting burden on small laboratories. In the CLFS final rule (81 FR 41051), we estimated that 95 percent of physician office laboratories and 55 percent of independent laboratories would not be required to report applicable information under our low expenditure criterion. Although we substantially reduced the number of laboratories qualifying as applicable laboratories (that is, approximately 5 percent of physician office laboratories and approximately 45 percent of independent laboratories), we estimated that the percentage of Medicare utilization would remain high. That is, approximately 5 percent of physician office laboratories would account for approximately 92 percent of CLFS
We stated that it is our understanding that physician offices are generally not prepared to identify, collect, and report each unique private payor rate from each private payor for each laboratory test code subject to the data collection and reporting requirements, and the volume associated with each unique private payor rate. As such, we explained that we believe revising the low expenditure threshold so that more physician office laboratories are required to report applicable information would likely impose significant administrative burdens on physician offices. We stated that we also believe that increasing participation from physician office laboratories would have minimal overall impact on payment rates given that the weighted median of private payor rates is dominated by the laboratories with the largest test volume. We noted that our participation simulations from the first data reporting period show that increasing the volume of physician office laboratories reporting applicable information has minimal overall impact on the weighted median of private payor rates. For more information on our participation simulations, please visit the CLFS website at
We stated in the proposed rule that we continue to believe the current low expenditure threshold strikes an appropriate balance between collecting enough private payor rate data to accurately represent the weighted median of private payor rates while limiting the administrative burden on small laboratories. In addition, as discussed previously in this section, we are finalizing excluding MA plan revenues under Part C from total Medicare revenues in the definition of applicable laboratory, and we noted that we expect more laboratories of all types, including physician office laboratories, may meet the majority of Medicare revenues threshold.
However, we recognized from stakeholders that some physician office laboratories and small independent laboratories that are not applicable laboratories because they do not meet the current low expenditure threshold may still want to report applicable information despite the administrative burden associated with qualifying as an applicable laboratory. Therefore, we sought public comment on revising the low expenditure threshold to increase the level of participation among physician office laboratories and small independent laboratories.
In the proposed rule we explained that one approach could be for us to decrease the low expenditure threshold by 50 percent, from $12,500 to $6,250, in CLFS revenues during a data collection period. Under such an approach, a laboratory would need to receive at least $6,250 in CLFS revenues in a data collection period. We stated that if we were to adopt such an approach, we would need to revise paragraph (4) of the definition of applicable laboratory at § 414.502 to replace $12,500 with $6,250. We solicited public comments on this approach.
We noted that we were particularly interested in comments from the physician community and small independent laboratories as to the administrative burden associated with such a revision to the low expenditure threshold. Specifically, we requested comments on the following issues: (1) Whether physician offices and small independent laboratories currently have adequate staff levels to meet the data collection and data reporting requirements; (2) whether data systems are currently in place to identify, collect, and report each unique private payor rate from each private payor for each CLFS test code and the volume of tests associated with each unique private payor rate; (3) if physician offices and small independent laboratories are generally not prepared to conduct the data collection and data reporting requirements, what is the anticipated timeframe needed for physician office and small independent laboratories to be able to meet the data collection and data reporting requirements; and (4) any other administrative concerns that decreasing the low expenditure threshold may impose on offices and small independent laboratories.
The following is a summary of the comments we received and our responses to the comments regarding the approach of decreasing the low expenditure threshold by 50 percent, from $12,500 to $6,250, in CLFS revenues during a data collection period.
We also discussed in the CY 2019 PFS proposed rule that we recognize many small laboratories may not want the additional administrative burden of data collection and reporting and, because their test volume is relatively low, their data is unlikely to have a meaningful impact on the weighted median of private payor rates for CDLTs under the CLFS. In response to comments from smaller laboratories that they prefer to not be applicable laboratories because of the burden of collecting and reporting applicable information, we stated that we could increase the low expenditure threshold in the definition of applicable laboratory by 50 percent, from $12,500 to $18,750, in CLFS revenues during a data collection period. Because physician office laboratories would be less likely to meet a higher threshold, such an approach would decrease the number of physician office laboratories and small independent laboratories required to collect and report applicable information. We noted that we expected decreasing the number of physician office laboratories and small independent laboratories reporting applicable information would have minimal impact on determining CLFS rates because the largest laboratories with the highest test volumes dominate the weighted median of private payor rates.
We stated that if we were to adopt such an approach, we would need to revise paragraph (4) of the definition of applicable laboratory at § 414.502 to replace $12,500 with $18,750. We explained in the proposed rule that we were particularly interested in comments from the physician community and small independent laboratories on the administrative burden and relief of increasing the low expenditure threshold and noted that we believe that feedback on the topics discussed in this section would help inform us regarding potential refinements to the low expenditure threshold. We noted that depending on the comments we received, we would consider approaches described in this section.
The following is a summary of the comments we received and our responses to the comments regarding the approach of increasing the low expenditure threshold by 50 percent, from $12,500 to $18,750, in CLFS revenues during a data collection period.
With regard to the commenters suggesting that we implement aggregate reporting, we note that section 1834A(a)(6) of the Act permits the Secretary, beginning with January 1, 2019, to establish rules to aggregate reporting in situations where an applicable laboratory has more than one payment rate for the same payor for the same test or more than one payment rate for different payors for the same test. While the agency did not propose or solicit comments on implementing aggregate data reporting, we will take the commenters' suggestion into consideration for future refinements to the CLFS. However, to help reduce administrative burden for the next data reporting period, we will allow reporting entities the option to condense certain applicable information at the TIN-level, instead of reporting for each applicable laboratory individually at the NPI level. We will provide more information regarding the condensed reporting option through subregulatory guidance during the next data collection period.
Under the ambulance fee schedule, the Medicare program pays for ambulance transportation services for Medicare beneficiaries under Medicare Part B when other means of transportation are contraindicated by the beneficiary's medical condition and all other coverage requirements are met. Ambulance services are classified into different levels of ground (including water) and air ambulance services based on the medically necessary treatment provided during transport.
These services include the following levels of service:
• For Ground—
++ Basic Life Support (BLS) (emergency and non-emergency).
++ Advanced Life Support, Level 1 (ALS1) (emergency and non-emergency).
++ Advanced Life Support, Level 2 (ALS2).
++ Paramedic ALS Intercept (PI).
++ Specialty Care Transport (SCT).
• For Air—
++ Fixed Wing Air Ambulance (FW).
++ Rotary Wing Air Ambulance (RW).
Under sections 1834(l) and 1861(s)(7) of the Act, Medicare Part B (Supplemental Medical Insurance) covers and pays for ambulance services, to the extent prescribed in regulations, when the use of other methods of transportation would be contraindicated by the beneficiary's medical condition.
The House Ways and Means Committee and Senate Finance Committee Reports that accompanied the 1965 Social Security Amendments suggest that the Congress intended that—
• The ambulance benefit cover transportation services only if other means of transportation are contraindicated by the beneficiary's medical condition; and
• Only ambulance service to local facilities be covered unless necessary services are not available locally, in which case, transportation to the nearest facility furnishing those services is covered (H.R. Rep. No. 213, 89th Cong., 1st Sess. 37 and Rep. No. 404, 89th Cong., 1st Sess. Pt 1, 43 (1965)).
The reports indicate that transportation may also be provided from one hospital to another, to the beneficiary's home, or to an extended care facility.
The regulations relating to ambulance services are set forth at 42 CFR part 410, subpart B, and 42 CFR part 414, subpart H. Section 410.10(i) lists ambulance services as one of the covered medical and other health services under Medicare Part B. Therefore, ambulance services are subject to basic conditions and limitations set forth at § 410.12 and to specific conditions and limitations included at §§ 410.40 and 410.41. Subpart H of part 414 describes how payment is made for ambulance services covered by Medicare Part B.
Section 146(a) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), (Pub. L. 110-275, enacted July 15, 2008) amended section 1834(l)(13)(A) of the Act to specify that, effective for ground ambulance services furnished on or after July 1, 2008, and before January 1, 2010, the ambulance fee schedule amounts for ground ambulance services shall be increased as follows:
• For covered ground ambulance transports that originate in a rural area or in a rural census tract of a metropolitan statistical area, the fee schedule amounts shall be increased by 3 percent.
• For covered ground ambulance transports that do not originate in a rural area or in a rural census tract of a metropolitan statistical area, the fee schedule amounts shall be increased by 2 percent.
The payment add-ons under section 1834(l)(13)(A) of the Act have been extended several times. Most recently, section 50203(a)(1) of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123, enacted February 9, 2018) amended section 1834(l)(13)(A) of the Act to extend the payment add-ons through
This statutory requirement is self-implementing. A plain reading of the statute requires only a ministerial application of the mandated rate increase, and does not require any substantive exercise of discretion on the part of the Secretary.
We received two comments on this proposal. The following is a summary of those comments along with our response.
After consideration of the comments received, we are finalizing our proposal, without modification, to revise § 414.610(c)(1)(ii) to conform the regulations to this statutory requirement.
Section 414(c) of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (Pub. L. 108-173, enacted December 8, 2003) (MMA) added section 1834(l)(12) to the Act, which specified that, in the case of ground ambulance services furnished on or after July 1, 2004, and before January 1, 2010, for which transportation originates in a qualified rural area (as described in the statute), the Secretary shall provide for a percent increase in the base rate of the fee schedule for such transports. The statute requires this percent increase to be based on the Secretary's estimate of the average cost per trip for such services (not taking into account mileage) in the lowest quartile of all rural county populations as compared to the average cost per trip for such services (not taking into account mileage) in the highest quartile of rural county populations. Using the methodology specified in the July 1, 2004 interim final rule (69 FR 40288), we determined that this percent increase was equal to 22.6 percent. As required by the MMA, this payment increase was applied to ground ambulance transports that originated in a “qualified rural area,” that is, to transports that originated in a rural area included in those areas comprising the lowest 25th percentile of all rural populations arrayed by population density. For this purpose, rural areas included Goldsmith areas (a type of rural census tract). This rural bonus is sometimes referred to as the “Super Rural Bonus” and the qualified rural areas (also known as “super rural” areas) are identified during the claims adjudicative process via the use of a data field included in the CMS-supplied ZIP code file.
The Super Rural Bonus under section 1834(l)(12) of the Act has been extended several times. Most recently, section 50203(a)(2) of the BBA amended section 1834(l)(12)(A) of the Act to extend this rural bonus through December 31, 2022. Therefore, we are continuing to apply the 22.6 percent rural bonus described in this section (in the same manner as in previous years) to ground ambulance services with dates of service before January 1, 2023 where transportation originates in a qualified rural area. Accordingly, we proposed to revise § 414.610(c)(5)(ii) to conform the regulations to this statutory requirement. (For further information regarding the implementation of this provision for claims processing, please see CR 10531. For a discussion of past legislation extending section 1834(l)(12) of the Act, please see the CY 2014 PFS final rule with comment period (78 FR 74439 through 74440), CY 2015 PFS final rule with comment period (79 FR 67743 through 67744) and the CY 2016 PFS final rule with comment period (80 FR 71072)).
This statutory provision is self-implementing. It requires an extension of this rural bonus (which was previously established by the Secretary) through December 31, 2022, and does not require any substantive exercise of discretion on the part of the Secretary.
We received two comments on this proposal. The following is a summary of those comments along with our response.
After consideration of the comments received, we are finalizing our proposal, without modification, to revise § 414.610(c)(5)(ii) to conform the regulations to this statutory requirement.
Section 637 of the American Taxpayer Relief Act of 2012 (ATRA) (Pub. L. 112-240, enacted January 2, 2013) added section 1834(l)(15) of the Act to specify that the fee schedule amount otherwise applicable under the preceding provisions of section 1834(l) of the Act shall be reduced by 10 percent for ambulance services furnished on or after October 1, 2013, consisting of non-emergency BLS services involving transport of an individual with end-stage renal disease for renal dialysis services (as described in section 1881(b)(14)(B) of the Act) furnished other than on an emergency basis by a provider of services or a renal dialysis facility. In the CY 2014 PFS final rule with comment period (78 FR 74440), we revised § 414.610 by adding paragraph (c)(8) to conform the regulations to this statutory requirement.
Section 53108 of the BBA amended section 1834(l)(15) of the Act to increase the reduction from 10 percent to 23 percent effective for ambulance services (as described in section 1834(l)(15) of the Act) furnished on or after October 1, 2018. The 10 percent reduction applies for ambulance services (as described in section 1834(l)(15) of the Act) furnished during the period beginning on October 1, 2013 and ending on September 30, 2018. Accordingly, we proposed to revise § 414.610(c)(8) to conform the regulations to this statutory requirement.
This statutory requirement is self-implementing. A plain reading of the statute requires only a ministerial application of the mandated rate decrease, and does not require any substantive exercise of discretion on the part of the Secretary. Accordingly, for ambulance services described in section
We received two comments on this proposal. The following is a summary of those comments along with our response.
After consideration of the comments received, we are finalizing our proposal, without modification, to revise § 414.610(c)(8) to conform the regulations to the statutory requirement described above.
In the CY 2018 PFS final rule, we revised the payment methodology for Chronic Care Management (CCM) services furnished by RHCs and FQHCs, and established requirements and payment for general Behavioral Health Integration (BHI) and psychiatric Collaborative Care Management (CoCM) services furnished in RHCs and FQHCs, beginning on January 1, 2018.
For CCM services furnished by RHCs or FQHCs between January 1, 2016, and December 31, 2017, payment is at the PFS national average payment rate for CPT 99490. For CCM, general BHI, and psychiatric CoCM services furnished by RHCs or FQHCs on or after January 1, 2018, we established 2 new HCPCS codes. The first HCPCS code, G0511, is a General Care Management code for use by RHCs or FQHCs when at least 20 minutes of qualified CCM or general BHI services are furnished to a patient in a calendar month. The second HCPCS code, G0512, is a psychiatric CoCM code for use by RHCs or FQHCs when at least 70 minutes of initial psychiatric CoCM services or 60 minutes of subsequent psychiatric CoCM services are furnished to a patient in a calendar month.
The payment amount for HCPCS code G0511 is set at the average of the 3 national non-facility PFS payment rates for the CCM and general BHI codes and updated annually based on the PFS amounts. The 3 codes are CPT 99490 (20 minutes or more of CCM services), CPT 99487 (60 minutes or more of complex CCM services), and CPT 99484 (20 minutes or more of BHI services).
The payment amount for HCPCS code G0512 is set at the average of the 2 national non-facility PFS payment rates for CoCM codes and updated annually based on the PFS amounts. The 2 codes are CPT 99492 (70 minutes or more of initial psychiatric CoCM services) and CPT 99493 (60 minutes or more of subsequent psychiatric CoCM services).
For practitioners billing under the PFS, we proposed for CY 2019 a new CPT code, 994X7, which would correspond to 30 minutes or more of CCM furnished by a physician or other qualified health care professional and is similar to CPT codes 99490 and 99487. For RHCs and FQHCs, we proposed to add CPT code 994X7 as a general care management service and to include it in the calculation of HCPCS code G0511. That is, we proposed that starting on January 1, 2019, RHCs and FQHCs would be paid for HCPCS code G0511 based on the average of the national non-facility PFS payment rates for CPT codes 99490, 99487, 99484, and 994X7. We note that CPT code 994X7 was a placeholder code, and the final code is CPT code 99491.
We proposed to revise § 405.2464 to reflect the current payment methodology that was finalized in the CY 2018 PFS and incorporate the addition of the new CPT code to HCPCS code G0511.
RHC and FQHC visits are face-to-face (in-person) encounters between a patient and an RHC or FQHC practitioner during which time one or more RHC or FQHC qualifying services are furnished. RHC and FQHC practitioners are physicians, nurse practitioners, physician assistants, certified nurse midwives, clinical psychologists, and clinical social workers, and under certain conditions, a registered nurse or licensed practical nurse furnishing care to a homebound RHC or FQHC patient. A Transitional Care Management service can also be an RHC or FQHC visit. A Diabetes Self-Management Training (DSMT) service or a Medical Nutrition Therapy (MNT) service furnished by a certified DSMT or MNT provider may also be an FQHC visit.
RHCs are paid an all-inclusive rate (AIR) for medically-necessary, face-to-face visits with an RHC practitioner. The rate is subject to a payment limit, except for those RHCs that have an exception to the payment limit for being “provider-based” (see § 413.65). FQHCs are paid the lesser of their charges or the FQHC Prospective Payment System (PPS) rate for medically-necessary, face-to-face visits with an FQHC practitioner. Only medically-necessary medical, mental health, or qualified preventive health services that require the skill level of an RHC or FQHC practitioner can be RHC or FQHC billable visits.
The RHC and FQHC payment rates reflect the cost of all services and supplies that an RHC or FQHC furnishes to a patient in a single day, and are not adjusted for the complexity of the patient health care needs, the length of the visit, or the number or type of practitioners involved in the patient's care.
Services furnished by auxiliary personnel (such as nurses, medical assistants, or other clinical personnel acting under the supervision of the RHC or FQHC practitioner) are considered incident to the visit and are included in the per-visit payment. This may include services furnished prior to or after the billable visit that occur within a medically appropriate time period, which is usually 30 days or less.
RHCS and FQHCs are also paid for care management services, including chronic care management services, general behavioral health integration services, and psychiatric Collaborative Care Model services. These are typically non-face-to-face services that do not require the skill level of an RHC or FQHC practitioner and are not included in the RHC or FQHC payment methodologies.
For practitioners billing under the PFS, we proposed for CY 2019 separate payment for certain communication technology-based services. This includes what is referred to as “Brief Communication Technology-Based Services” for a “virtual check-in” and separate payment for remote evaluation of recorded video and/or images. The “virtual check-in” visit would be
The RHC and FQHC payment models are distinct from the PFS model in that the payment is for a comprehensive set of services and supplies associated with an RHC or FQHC visit. A direct comparison between the payment for a specific service furnished in an RHC or FQHC and the same service furnished in a physician's office is not possible, because the payment for RHCs and FQHCs is a per diem payment that includes the cost for all services and supplies rendered during an encounter, and payment for a service furnished in a physician's office and billed under the PFS is only for that service.
We recognize that there are occasions when it may be beneficial to both the patient and the RHC or FQHC to utilize communication technology-based services to determine the course of action for a health issue. Currently under the RHC and FQHC payment systems, if the communication results in a face-to-face billable visit with an RHC or FQHC practitioner, the cost of the prior communication would be included in the RHC AIR or the FQHC PPS. However, if as a result of the communication it is determined that a visit is not necessary, there would not be a billable visit and there would be no payment.
RHCs and FQHCs furnish services in rural and urban areas that have been determined to be medically underserved areas or health professional shortage areas. They are an integral component of the Nation's health care safety net, and we want to ensure that Medicare patients who are served by RHCs and FQHCs are able to communicate with their RHC or FQHC practitioner in a manner that enhances access to care, consistent with evolving medical care. Particularly in rural areas where transportation is limited and distances may be far, we believe the use of communication technology-based services may help some patients to determine if they need to schedule a visit at the RHC or FQHC. If it is determined that a visit is not necessary, the RHC or FQHC practitioner would be available for other patients who need their care.
When communication technology-based services are furnished in association with an RHC or FQHC billable visit, the costs of these services are included in the RHC AIR or the FQHC PPS and are not separately billable. However, if there is no RHC or FQHC billable visit, these costs are not paid as part of an RHC AIR or FQHC PPS payment. We therefore proposed that, effective January 1, 2019, RHCs and FQHCs receive an additional payment for the costs of communication technology-based services or remote evaluation services that are not already captured in the RHC AIR or the FQHC PPS payment when the requirements for these services are met.
We proposed that RHCs and FQHCs receive payment for communication technology-based or remote evaluation services when at least 5 minutes of communication technology-based or remote evaluation services are furnished by an RHC or FQHC practitioner to a patient who has been seen in the RHC or FQHC within the previous year. These services may only be billed when the medical discussion or remote evaluation is for a condition not related to an RHC or FQHC service provided within the previous 7 days, and does not lead to an RHC or FQHC service within the next 24 hours or at the soonest available appointment, since in those situations the services are already paid as part of the RHC or FQHC per-visit payment.
We proposed to create a new virtual communication G-code for use by RHCs and FQHCs only, with a payment rate set at the average of the PFS national non-facility payment rates for HCPCS code GVCI1 for communication technology-based services, and HCPCS code GRAS1 for remote evaluation services. RHCs and FQHCs would be able to bill the virtual communication G-code either alone or with other payable services. The payment rate for the virtual communication G-code would be updated annually based on the PFS amounts. We note that HCPCS codes GCVI1 and GRAS1 were placeholder codes, and the final HCPCS codes are G2012 and G2010, respectively.
We also proposed to waive the RHC and FQHC face-to-face requirements when these services are furnished to an RHC or FQHC patient. Coinsurance would be applied to FQHC claims, and coinsurance and deductibles would apply to RHC claims for these services. Services that are currently being furnished and paid under the RHC AIR or FQHC PPS payment methodology will not be affected by the ability of the RHC or FQHC to receive payment for additional services that are not included in the RHC AIR or FQHC PPS.
We considered other options for payment for these services. First, we considered adding communication technology-based and remote evaluation services as an RHC or FQHC stand-alone service. Under this option, payment for RHCs would be at the AIR, and payment for FQHCs would be the lesser of total charges or the PPS rate. We did not propose this payment option because these services do not meet the requirements for an RHC or FQHC billable visit and payment at the RHC AIR or FQHC PPS would result in a payment rate incongruent with efficiencies inherent in the provision of the technology-based services.
The second option we considered was to allow RHCs and FQHCs to bill HCPCS codes G2012 or G2010 separately on an RHC or FQHC claim. We did not propose this payment option because we believe that a combined G-code is less burdensome and will allow expansion of these services without adding additional codes on an RHC or FQHC claim.
We invited comments on this proposal. In particular, we were interested in comments regarding the appropriateness of payment for communication technology-based and remote evaluation services in the absence of an RHC or FQHC visit, the burden associated with documentation for billing these codes (RHC or FQHC practitioner's time, medical records, etc.), and any potential impact on the per diem nature of RHC and FQHC billing and payment structure as a result of payment for these services.
The following is a summary of the comments we received regarding the addition of CPT code 99491 to the codes used to determine the payment for HCPCS code G0511 in RHCs and FQHCs, and the proposed requirements and payment for a new G-code for virtual communication for payment for communication technology-based and remote evaluation services. The majority of the commenters were very supportive of both proposals, and some requested clarification on issues related to billing, cost reporting, and payment for care management and virtual communication services in RHCs and FQHCs.
CPT code 99491 is for 30 minutes or more of CCM furnished by a physician or other qualified health care professional. Since this is similar to CPT codes 99490 and 99487, we determined that it should be included in the RHC and FQHC General Care Management code, which is paid using HCPCS code G0511. The CY 2019 payment rate for this code is expected to be $74.26, and the payment rate for CY 2019 payment rate for HCPCS code G0511 is expected to be approximately $67, which will result in a higher payment for HCPCS code G0511 than it would have been if CPT code 99491 was not added to the codes used to determine the rate. The rate is adjusted annually based on the PFS payment rates for these codes.
Section 1834(m)(4)(C)(ii) of the Act authorizes RHCs and FQHCs to serve as telehealth “originating sites” (that is, where the patient is located) for qualified telehealth services. Section 1834(m)(1) of the Act, which describes distant site telehealth services (where the practitioner is located), does not include RHCs and FQHCs. We do not have the authority to allow RHCs and FQHCs to furnish distant site telehealth services, and RHCs and FQHCs may not bill for distant site telehealth services under the PFS.
Except for the Initial Preventive Physical Exam and the Annual Wellness Visit, RHC and FQHC visits do not have frequency limitations, and a patient could have more than one RHC or FQHC billable visit in the same week if it is a medically-necessary, face-to-face visit with an RHC or FQHC practitioner. If a service is not medically-necessary, or is not furnished by an RHC or FQHC practitioner, or does not require the skill level of an RHC or FQHC practitioner, it would not be a billable visit. Since the RHC AIR and FQHC PPS payment methodologies are designed to include all services and supplies incident to a visit, the absence of time restrictions could result in duplicate payment to the RHC or FQHC. Since the virtual communication payment is designed to provide payment to the RHC or FQHC when there is no billable visit, the time restrictions are necessary to avoid any duplicate payment.
Communication technology-based and remote evaluation services are initiated by a patient who has been seen in the past year by the RHC or FQHC practitioner, and in many cases, a review of prior patient clinical activity and diagnoses would be necessary as part of the virtual communication with the patient. Since most RHCs and FQHCs are utilizing electronic health records, we expect that RHCs and
As a result of the comments, we are finalizing the following provisions:
• Effective January 1, 2019, the payment rate for HCPCS code G0511 (General Care Management Services) is set at the average of the national non-facility PFS payment rates for CPT codes 99490, 99487, 99484, and 99491.
• Effective January 1, 2019, RHCs and FQHCs are paid for HCPCS code G0071 (Virtual Communication Services), when HCPCS code G0071 is on an RHC or FQHC claim, either alone or with other payable services, and at least 5 minutes of communication technology-based or remote evaluation services are furnished by an RHC or FQHC practitioner to a patient who has had an RHC or FQHC billable visit within the previous year, and the medical discussion or remote evaluation is for a condition not related to an RHC or FQHC service provided within the previous 7 days, and does not lead to an RHC or FQHC visit within the next 24 hours or at the soonest available appointment. We are adding a new paragraph (e) to § 405.2464 to reflect this payment and making additional minor conforming changes to this section.
• HCPCS code G0071 is set at the average of the national non-facility PFS payment rates for HCPCS code G2012
• RHC and FQHC face-to-face requirements are waived when these services are furnished to an RHC or FQHC patient. Coinsurance and deductibles apply to RHC claims for G0071 and coinsurance applies to FQHC claims for G0071.
In addition to the regulatory change described in this section of the rule, we are finalizing the following technical corrections for accuracy:
• Removal of the extra section mark in the definition of “Federally qualified health center (FQHC)” in § 405.2401.
• Replacing the word “his” with “his or her” in the definition of “Secretary” in § 405.2401.
• Reordering the occurrence of RHC and FQHC in § 405.2462(g).
Section 6083 of the SUPPORT for Patients and Communities Act (Pub. L. 115-271, enacted on October 24, 2018) provides additional payments to RHCs and FQHCs for services furnished for the treatment of opioid use disorders by practitioners meeting certain requirements. We anticipate guidance from the Department of Health and Human Services on the implementation of this provision will be forthcoming.
Section 218(b) of the Protecting Access to Medicare Act (PAMA) (Pub. L. 113-93, enacted April 1, 2014) amended Title XVIII of the Act to add section 1834(q) of the Act directing us to establish a program to promote the use of appropriate use criteria (AUC) for advanced diagnostic imaging services. The CY 2016 PFS final rule with comment period addressed the initial component of the new Medicare AUC program, specifying applicable AUC. In that rule (80 FR 70886), we established an evidence-based process and transparency requirements for the development of AUC, defined provider-led entities (PLEs) and established the process by which PLEs may become qualified to develop, modify or endorse AUC. The first list of qualified PLEs was posted on the CMS website at the end of June 2016 at which time their AUC libraries became specified applicable AUC for purposes of section 1834(q)(2)(A) of the Act. The CY 2017 PFS final rule addressed the second component of this program, specification of qualified clinical decision support mechanisms (CDSMs). In the CY 2017 PFS final rule (81 FR 80170), we defined CDSM, identified the requirements CDSMs must meet for qualification, including preliminary qualification for mechanisms documenting how and when each requirement is reasonably expected to be met, and established a process by which CDSMs may become qualified. We also defined applicable payment systems under this program, specified the first list of priority clinical areas, and identified exceptions to the requirement that ordering professionals consult specified applicable AUC when ordering applicable imaging services. The first list of qualified CDSMs was posted on the CMS website in July 2017.
The CY 2018 PFS final rule addressed the third component of this program, the consultation and reporting requirements. In the CY 2018 PFS final rule (82 FR 53190), we established the start date of January 1, 2020 for the Medicare AUC program for advanced diagnostic imaging services. It is for services ordered on and after this date that ordering professionals must consult specified applicable AUC using a qualified CDSM when ordering applicable imaging services, and furnishing professionals must report AUC consultation information on the Medicare claim. We further specified that the AUC program will begin on January 1, 2020 with a year-long educational and operations testing period during which time AUC consultation information is expected to be reported on claims, but claims will not be denied for failure to include proper AUC consultation information. We also established a voluntary period from July 2018 through the end of 2019 during which ordering professionals who are ready to participate in the AUC program may consult specified applicable AUC through qualified CDSMs and communicate the results to furnishing professionals, and furnishing professionals who are ready to do so may report AUC consultation information on the claim (
In the CY 2019 PFS proposed rule, we proposed additions to the definition of applicable setting, clarification around who may perform the required AUC consultation using a qualified CDSM under this program, clarification that reporting is required across claim types and by both the furnishing professional and furnishing facility, changes to the policy for significant hardship exceptions for ordering professionals under this program, mechanisms for claims-based reporting, and a solicitation of feedback regarding the methodology to identify outlier ordering professionals.
AUC present information in a manner that links: A specific clinical condition or presentation; one or more services; and an assessment of the appropriateness of the service(s). Evidence-based AUC for imaging can assist clinicians in selecting the imaging study that is most likely to improve health outcomes for patients based on their individual clinical presentation. For purposes of this program, AUC is a set or library of individual appropriate use criteria. Each individual criterion is an evidence-based guideline for a particular clinical scenario based on a patient's presenting symptoms or condition.
AUC need to be integrated as seamlessly as possible into the clinical workflow. CDSMs are the electronic portals through which clinicians access the AUC during the patient workup. They can be standalone applications that require direct entry of patient information, but may be more effective when they are integrated into electronic health records (EHRs). Ideally, practitioners would interact directly with the CDSM through their primary user interface, thus minimizing interruption to the clinical workflow.
Section 218(b) of the PAMA added a new section 1834(q) of the Act entitled, “Recognizing Appropriate Use Criteria for Certain Imaging Services,” which directs the Secretary to establish a new program to promote the use of AUC. Section 1834(q)(4) of the Act requires
There are four major components of the AUC program under section 1834(q) of the Act, and each component has its own implementation date: (1) Establishment of AUC by November 15, 2015 (section 1834(q)(2) of the Act); (2) identification of mechanisms for consultation with AUC by April 1, 2016 (section 1834(q)(3) of the Act); (3) AUC consultation by ordering professionals, and reporting on AUC consultation by January 1, 2017 (section 1834(q)(4) of the Act); and (4) annual identification of outlier ordering professionals for services furnished after January 1, 2017 (section 1834(q)(5) of the Act). We did not identify mechanisms for consultation by April 1, 2016. Therefore, we did not require ordering professionals to consult CDSMs or furnishing professionals to report information on the consultation by the January 1, 2017 date.
In the CY 2016 PFS final rule with comment period, we addressed the first component of the Medicare AUC program under section 1834(q)(2) of the Act—the requirements and process for establishment and specification of applicable AUC, along with relevant aspects of the definitions under section 1834(q)(1) of the Act. This included defining the term “provider-led entity” and finalizing requirements for the rigorous, evidence-based process by which a PLE would develop AUC, upon which qualification is based, as provided in section 1834(q)(2)(B) of the Act and in the CY 2016 PFS final rule with comment period. Using this process, once a PLE is qualified by us, the AUC that are developed, modified or endorsed by the qualified PLE are considered to be specified applicable AUC under section 1834(q)(2)(A) of the Act. We defined PLE to include national professional medical societies, health systems, hospitals, clinical practices and collaborations of such entities such as the High Value Healthcare Collaborative or the National Comprehensive Cancer Network. Qualified PLEs may collaborate with third parties that they believe add value to their development of AUC, provided such collaboration is transparent. We expect qualified PLEs to have sufficient infrastructure, resources, and the relevant experience to develop and maintain AUC according to the rigorous, transparent, and evidence-based processes detailed in the CY 2016 PFS final rule with comment period.
In the same rule we established a timeline and process under § 414.94(c)(2) for PLEs to apply to become qualified. Consistent with this timeline the first list of qualified PLEs was published at
In the CY 2017 PFS final rule, we addressed the second major component of the Medicare AUC program—the specification of qualified CDSMs for use by ordering professionals for consultation with specified applicable AUC under section 1834(q)(3) of the Act, along with relevant aspects of the definitions under section 1834(q)(1) of the Act. This included defining the term CDSM and finalizing functionality requirements of mechanisms, upon which qualification is based, as provided in section 1834(q)(3)(B) of the Act and in the CY 2017 PFS final rule. CDSMs may receive full qualification or preliminary qualification if most, but not all, of the requirements are met at the time of application. The preliminary qualification period began June 30, 2017 and ends when the AUC consulting and reporting requirements become effective on January 1, 2020. The preliminarily qualified CDSMs must meet all requirements by that date. We defined CDSM as an interactive, electronic tool for use by clinicians that communicates AUC information to the user and assists them in making the most appropriate treatment decision for a patient's specific clinical condition. Tools may be modules within or available through certified EHR technology (as defined in section 1848(o)(4) of the Act) or private sector mechanisms independent from certified EHR technology or a mechanism established by the Secretary.
In the CY 2017 PFS final rule, we established a timeline and process in § 414.94(g)(2) for CDSM developers to apply to have their CDSMs qualified. Consistent with this timeline, the first list of qualified CDSMs was published at
In the CY 2018 PFS final rule, we addressed the third major component of the Medicare AUC program—consultation with applicable AUC by the ordering professional and reporting of such consultations under section 1834(q)(4) of the Act. We established a January 1, 2020 effective date for the AUC consultation and reporting requirements for this program. We also established a voluntary period during which early adopters can begin reporting limited consultation information on Medicare claims from July 2018 through December 2019. During the voluntary period there is no requirement for ordering professionals to consult AUC or furnishing professionals to report information related to the consultation. On January 1, 2020, the program will begin with an educational and operations testing period and during this time we will continue to pay claims whether or not they correctly include AUC consultation information. Ordering professionals must consult specified applicable AUC through qualified CDSMs for applicable imaging services furnished in an applicable setting, paid for under an applicable payment system and ordered on or after January 1, 2020; and furnishing professionals must report the AUC consultation information on the Medicare claim for these services ordered on or after January 1, 2020.
Consistent with section 1834(q)(4)(B) of the Act, we also established that furnishing professionals must report the following information on Medicare claims for advanced diagnostic imaging services as specified in section 1834(q)(1)(C) of the Act and defined in § 414.94(b), furnished in an applicable setting as defined in section 1834(q)(1)(D) of the Act, paid for under an applicable payment system as defined in section 1834(q)(4)(D) of the Act, and ordered on or after January 1, 2020: (1) The qualified CDSM consulted by the ordering professional; (2) whether the service ordered would or would not adhere to specified applicable AUC, or whether the specified applicable AUC consulted was not applicable to the service ordered; and (3) the NPI of the ordering professional (if different from the furnishing professional). Clarifying revisions to the reporting requirement are discussed later in this preamble.
Section 1834(q)(4)(C) of the Act provides for exceptions to the AUC consultation and reporting requirements in the case of: A service ordered for an
Section 1834(q)(4)(D) of the Act specifies the applicable payment systems for which AUC consultation and reporting requirements apply and, in the CY 2017 PFS final rule, consistent with the statute, we defined applicable payment system in our regulation at § 414.94(b) as: (1) The PFS established under section 1848(b) of the Act; (2) the prospective payment system for hospital outpatient department services under section 1833(t) of the Act; and (3) the ambulatory surgical center payment system under section 1833(i) of the Act.
Section 1834(q)(1)(D) of the Act specifies the applicable settings in which AUC consultation and reporting requirements apply: A physician's office, a hospital outpatient department (including an emergency department), an ambulatory surgical center, and any other “provider-led outpatient setting determined appropriate by the Secretary.” In the CY 2017 PFS final rule, we added this definition to our regulation at § 414.94(b). Proposed additional applicable settings are discussed later in this preamble.
The fourth component of the Medicare AUC program is specified in section 1834(q)(5) of the Act, Identification of Outlier Ordering Professionals. The identification of outlier ordering professionals under this paragraph facilitates a prior authorization requirement that applies for outlier professionals beginning January 1, 2020, as specified under section 1834(q)(6) of the Act. Because we established a start date of January 1, 2020 for AUC consultation and reporting requirements, we will not have identified any outlier ordering professionals by that date. As such, implementation of the prior authorization component is delayed. However, we did finalize in the CY 2017 PFS final rule the first list of priority clinical areas to guide identification of outlier ordering professionals as follows:
• Coronary artery disease (suspected or diagnosed).
• Suspected pulmonary embolism.
• Headache (traumatic and non-traumatic).
• Hip pain.
• Low back pain.
• Shoulder pain (to include suspected rotator cuff injury).
• Cancer of the lung (primary or metastatic, suspected or diagnosed).
• Cervical or neck pain.
We did not include proposals to expand or modify the list of priority clinical areas in this final rule.
In the CY 2019 PFS proposed rule, we proposed to amend § 414.94 of our regulations, “Appropriate Use Criteria for Certain Imaging Services,” to reflect the following policies.
Section 1834(q)(1)(D) of the Act specifies that the AUC consultation and reporting requirements apply only in an applicable setting, which means a physician's office, a hospital outpatient department (including an emergency department), an ambulatory surgical center, and any other provider-led outpatient setting determined appropriate by the Secretary. In the CY 2017 PFS final rule, we codified this definition in § 414.94(b). We proposed to revise the definition of applicable setting to add an independent diagnostic testing facility (IDTF).
We believe the addition of IDTFs to the definition of applicable setting will ensure that the AUC program is in place across outpatient settings in which outpatient advanced diagnostic imaging services are furnished. IDTFs furnish services for a large number of Medicare beneficiaries; nearly $1 billion in claims for 2.4 million beneficiaries in 2010 (OEI-05-09-00560). An IDTF is independent of a hospital or physician's office and diagnostic tests furnished by an IDTF are performed by licensed, certified non-physician personnel under appropriate physician supervision (§ 410.33). Like other applicable settings, IDTFs must meet the requirements specified in § 410.33 of our regulations to be enrolled to furnish and bill for advanced diagnostic imaging and other IDTF services. Services that may be provided by an IDTF include, but are not limited to, magnetic resonance imaging (MRI), ultrasound, x-rays, and sleep studies. An IDTF may be a fixed location, a mobile entity, or an individual non-physician practitioner, and diagnostic procedures performed by an IDTF are paid under the PFS. IDTF services must be furnished under the appropriate level of physician supervision as specified in § 410.33(b); and all procedures furnished by the IDTF must be ordered in writing by the patient's treating physician or non-physician practitioner. As such, we believe the IDTF setting is a provider-led outpatient setting appropriate for addition to the list of applicable settings under section 1834(q)(1)(D), and we proposed to add IDTF to our definition of applicable setting under § 414.94(b) of the regulations.
We note that under the PFS, payment for many diagnostic tests including the advanced diagnostic imaging services to which the AUC program applies can be made either “globally” when the entire service is furnished and billed by the same entity; or payment can be made separately for the technical component (TC) of the service and the professional component (PC) when those portions of the service are furnished and billed by different entities. In general, the TC for an advanced diagnostic imaging service is the portion of the test during which the patient is present and the image is captured. The PC is the portion of the test that involves a physician's interpretation and report on the captured image. For example, when a CT scan is ordered by a patient's treating physician, the entire test (TC and PC) could be furnished by a radiologist in their office and billed as a “global” service. Alternatively, the TC could be furnished and billed by an IDTF, and the PC could be furnished and billed by a radiologist in private practice. By adding IDTFs as an
We proposed to revise the definition of applicable setting under § 414.94(b) to include an IDTF. We invited comments on this proposal and on the possible inclusion of any other applicable setting. We reminded commenters that application of the AUC program is not only limited to applicable settings, but also to services for which payment is made under applicable payment systems (the PFS, the OPPS, and the ASC payment system).
The following is a summary of the comments we received on revising the definition of applicable setting under § 414.94(b) to include an IDTF and on the possible inclusion of any other applicable setting.
After considering the comments, we are finalizing the proposal revising the definition of applicable setting under § 414.94(b) to include an IDTF.
Section 1834(q)(1)(E) of the Act defines the term “ordering professional” as a physician (as defined in section 1861(r)) or a practitioner described in section 1842(b)(18)(C) who orders an applicable imaging service. The AUC consultation requirement applies to these ordering professionals. We proposed that the consultation with AUC through a qualified CDSM may be performed by auxiliary personnel under the direction of the ordering professional and incident to the ordering professional's services, when the consultation is not performed personally by the ordering professional whose NPI will be listed on the order for an advanced imaging service.
In response to the CY 2018 PFS proposed rule, we received several public comments requesting clarification regarding who is required to perform the consultation of AUC through a qualified CDSM. Commenters not only sought clarification, but also provided recommendations for requirements around this topic. Some commenters recommended that CMS strictly interpret the statutory language and only allow the clinician placing the order to perform the consultation and others recommended that CMS allow others to perform the AUC consultation on behalf of the clinician.
Section 1834(q)(4)(A)(i) of the Act requires an ordering professional to consult with a qualified CDSM, and this was codified in our regulations at § 414.94(j). The statute does not explicitly provide for consultations under the AUC program to be fulfilled by other professionals, individuals or organizations on behalf of the ordering professional; however, we continue to seek ways to minimize the burden of this new Medicare program and understand that many practices currently use clinical staff, working under the direction of the ordering professional, to interact with the CDSM for AUC consultation and subsequent ordering of advanced diagnostic imaging. Therefore, we proposed to modify paragraph § 414.94(j) to specify that additional individuals may perform the required AUC consultation.
When the AUC consultation is not performed personally by the ordering professional, we proposed the consultation may be performed by auxiliary personnel incident to the ordering physician or non-physician practitioner's professional service. We believed this approach was appropriate under this program and still accomplishes the goal of promoting the use of AUC. This proposed policy would allow the ordering professional to exercise their discretion to delegate the performance of this consultation. It is important to note that the ordering professional is ultimately responsible for the consultation as their NPI is reported by the furnishing professional on the claim for the applicable imaging service; and that it is the ordering professional who could be identified as an outlier ordering professional and become subject to prior authorization based on their ordering pattern.
We proposed to revise the AUC consultation requirement specified at § 414.94(j) to specify that the AUC consultation may be performed by auxiliary personnel under the direction of the ordering professional and incident to the ordering professional's services.
The following is a summary of the comments we received on this proposal. Overall commenters either agreed or disagreed with the proposal to expand who can perform the consultation with a qualified CDSM, and the commenters that agreed with the concept of the proposal either requested clarification around the term auxiliary personnel or recommended that we use more specific language to describe eligible personnel.
Regardless of who performs the AUC consultation, the ordering professional is ultimately responsible for the order and may become subject to prior authorization if they demonstrate a pattern of non-adherent orders. Therefore, the ordering professional not only has a vested interest in terms of providing the right test for their patient, but also to monitor the frequency with which they order tests that do not adhere to AUC.
Some commenters suggested additional language that would identify specific licensed professionals, lay out training requirements, allow for medical assistants or credentialed clinical staff, cite state scope of practice laws, or require that the individual be present in the office of the ordering professional. These commenters stated that the AUC consultation should not be an administrative task that can be performed by any staff member, such as a receptionist or data entry clerk. The underlying concern of commenters that wanted to explicitly allow only clinical personnel to consult AUC was that the individual performing an AUC consultation would need to understand the patient's medical information, the advanced imaging service being recommended and the clinical information that is returned by the CDSM. Commenters stated that this understanding on the part of the individual who performs the AUC consultation was particularly important when a CDSM indicates that the order is not adherent to AUC.
Some commenters specifically addressed our proposal that the individual who consults AUC must be under the direction of the ordering professional. At least one commenter noted the need for direct supervision while another said the individual should be physically located in the office of the ordering professional as opposed to off-site. Other commenters suggested that we use language that allows for maximum flexibility.
One commenter gave an example that drew parallels between CDSMs and Computerized Provider Order Entry (CPOE) systems, and suggested the same requirements should apply to individuals consulting CDSMs. The commenter stated that for CPOE entries to count toward meeting Medicaid Meaningful Use thresholds, the entry must be made by a licensed healthcare professional or credentialed medical assistant. Similarly, the commenter suggested the consultation should be performed consistent with state scope of practice laws since the use of CPOE is limited to those individuals referenced above, as it is within their state scope of practice to enter orders into medical records.
We also agree that there are similarities between CPOE systems and CDSMs, and that individuals using these systems should have some level of knowledge of the clinical information they are inputting and, importantly, the information they receive back from the system. However, we also agree with the view of most commenters that ordering professionals should have flexibility to delegate the AUC consultation task. We also agree that the learning and educational aspects of AUC are more likely to be realized when there is real communication between the ordering professional and the person performing the consultation. While we proposed the consultation could be performed incident to the ordering professional's service, we agree with commenters that the “incident to” concept is difficult to apply to a service that is not billable and does not require the patient to be present. We further agree with comments recommending that there be good communication and a close relationship between the ordering professional and individual consulting the AUC. In the case of consulting AUC, we believe it is important that the individual who uses the CDSM is working under the ordering professional, and that the individual is available to the ordering professional to discuss the results of the consultation and any responsive adjustments to planned orders.
Based on the public comments received, we do not believe it would be appropriate to move forward with the proposal to specify the scope of individuals who can perform the AUC consultation as auxiliary personnel. We are modifying our proposal in response to comments, and conforming the regulation at § 414.94(j)(2), to clarify that, in the event of a significant hardship, the requirement to consult AUC does not apply and specify that, when not personally performed by the ordering professional, the consultation with a qualified CDSM may be performed by clinical staff under the direction of the ordering professional. We have used the term clinical staff elsewhere in the Medicare program to identify the individuals that may perform care management services including chronic care management (CCM), behavioral health integration (BHI) and transitional care management (TCM) services. These services involve some non-face-to-face services along with clinical activities around the care plan and communication and coordination with the patient's other healthcare professionals. For care management, the clinical staff requirement ensures that the individual performing the service must have the level of clinical knowledge necessary to effectively coordinate and communicate with the treating clinician. Similarly, in the case of the AUC program, the individual performing the AUC consultation must have sufficient clinical knowledge to interact with the CDSM and communicate with the ordering professional. After considering public comments on our proposal, we have concluded that allowing clinical staff to perform the AUC consultation under the direction of the ordering professional is a better fit with the AUC program than our proposal, and is responsive to public comments asserting that the concept of “incident to” is not relevant in the context of the AUC program. We believe the policy we are finalizing, to allow the AUC consultation to be performed by clinical staff under the direction of the ordering professional, further reflects a balance between those commenters who wanted only the ordering professional to perform the consultation and those who suggested we should allow the consultation to be delegated. Clinical staff will have a level of knowledge that allows for effective communication of advanced diagnostic imaging orders, interaction with AUC, and engagement with the ordering professional, while they remain under the direction of the ordering professional.
Section 1834(q)(4)(B) of the Act requires that payment for an applicable imaging service furnished in an applicable setting and paid for under an applicable payment system may only be made if the claim for the service includes certain information about the AUC consultation. As such, the statute requires that AUC consultation information be included on any claim for an outpatient advanced diagnostic imaging service, including those billed and paid under any applicable payment system (the PFS, OPPS or ASC payment system). When we initially codified the AUC consultation reporting requirement in § 414.94(k) through rulemaking in the CY 2018 PFS final rule, we specified only that “furnishing professionals” must report AUC consultation information on claims for applicable imaging services. This led some stakeholders to believe that AUC consultation information would be required only on practitioner claims. To better reflect the statutory requirements of section 1834(q)(4)(B) of the Act, we proposed to revise our regulations to clarify that AUC consultation information must be reported on all claims for an applicable imaging service furnished in an applicable setting and paid for under an applicable payment system. The revised regulation would more clearly express the scope of advanced diagnostic imaging services that are subject to the AUC program, that is, those furnished in an applicable setting and paid under an applicable payment system.
The language codified in § 414.94(k) uses the term furnishing professional to describe who must report the information on the Medicare claims. We recognize that section 1834(q)(1)(F) of the Act specifies that a “furnishing professional” is a physician (as defined in section 1861(r)) or a practitioner described in section 1842(b)(18)(C) who furnishes an applicable imaging service.
As such, we proposed to revise § 414.94(k) to clearly reflect the scope of claims for which AUC consultation information must be reported, and to clarify that the requirement to report AUC consultation information is not limited to the furnishing professional. The following is a summary of the comments we received.
After considering the comments, we are finalizing without modification the proposal to revise § 414.94(k) to clearly reflect the scope of claims for which AUC consultation information must be reported, and to make this requirement consistent with section 1834(q)(4)(B) of the Act.
In the CY 2018 PFS proposed rule (82 FR 34094) we discussed using a combination of G-codes and modifiers to report the AUC consultation information on the Medicare claim. We received numerous public comments objecting to this potential solution. In the 2018 PFS final rule, we agreed with many of the commenters that additional approaches to reporting AUC consultation information on Medicare claims should be considered, and we learned from many commenters that reporting a unique consultation identifier (UCI) would be a less burdensome and preferred approach. The UCI would include all the information required under section 1834(q)(4)(B) of the Act including an indication of AUC adherence, non-adherence and not applicable responses. Commenters noted that capturing a truly distinguishing UCI on the claim will allow for direct mapping from a single AUC consultation to embedded information within a CDSM. We indicated that we would work with stakeholders to further explore the concept of using a UCI to satisfy the requirements of section 1834(q)(4)(B) of the Act, which will be used for Medicare claims processing and, ultimately, for the identification of outlier ordering professionals, and consider developing a taxonomy for a UCI.
We had the opportunity to engage with some stakeholders over the last 6 months and we understand that some commenters from the previous rule continue to be in favor of a UCI, while some may have changed their position upon further consideration.
We provide the following information to summarize alternatives we considered. We had originally considered assigning a G-code for every qualified CDSM with a code descriptor containing the name of the qualified CDSM. The challenge to this approach arises when there is more than one advanced imaging service on a single claim. We could attribute a single G-code to all of the applicable imaging services for the patient's clinical condition on the claim, which might be appropriate if each AUC consultation for each service was through the same CDSM. If a different CDSM was used for each service (for example, when services on a single claim were ordered by more than one ordering professional and each ordering professional used a different CDSM) then multiple G-codes could be needed on the claim. Each G-code would appear on the claim individually as its own line item. As a potential solution, we considered the use of modifiers, which are appealing because they would appear on the same line as the CPT code that identifies the specific billed service. Therefore, information entered onto a claim would arrive into the claims processing system paired with the relevant AUC consultation information.
When reporting the required AUC consultation information based on the response from a CDSM: (1) The imaging service would adhere to the applicable AUC; (2) the imaging service would not adhere to such criteria; or (3) such criteria were not applicable to the imaging service ordered, three modifiers could be developed. These modifiers, when placed on the same line with the CPT code for the advanced imaging service would allow this information to be easily accessed in the Medicare claims data and matched with the imaging service.
Stakeholders have made various suggestions for a taxonomy that could be used to develop a UCI to report the required information. Stakeholders have also considered where to place the UCI on the claim. We understand the majority of solutions suggested by stakeholders involving a UCI are claim-
We have received ideas from stakeholders that are both for and against the two approaches we have identified; and we appreciate the stakeholders that have provided additional information or engaged us in this discussion. Internally, we have explored the possibility of using, and feasibility of developing, a UCI; and concluded that, although we initiated this approach during the CY 2018 PFS final rule, it is not feasible to create a uniform UCI taxonomy, determine a location of the UCI on the claims forms, obtain the support and permission by national bodies to use claim fields for this purpose, and solve the underlying issue that the UCI seems limited to claim-level reporting. Using coding structures that are already in place (such as G-codes and modifiers) would allow us to establish reporting requirements prior to the start of the program (January 1, 2020).
Since we did not finalize a proposal in the CY 2018 PFS final rule, we proposed in this rule to use established coding methods, to include G-codes and modifiers, to report the required AUC information on Medicare claims. This would allow the program to be implemented by January 1, 2020. We will consider future opportunities to use a UCI and look forward to continued engagement with and feedback from stakeholders.
The following is a summary of comments we received on this proposal.
Commenters pointed out that claims for both the furnishing facility and furnishing professional are capable of reporting G-codes and modifiers, but identified an issue related to resorting of information on claims as they are processed through the system. In other words, the codes billed on separate claim lines can come through the system and end up in a different order than how they originally appeared when the claim was submitted. This means CMS cannot presume to pair an imaging service reported on a specific claim line with a specific G-code when more than one imaging service appears on the claim. A commenter suggested that furnishing professionals could split their claims so only one imaging service and one G-code would appear on each claim. Commenters pointed out that while this is possible on the furnishing professional claim, it is not possible on the furnishing facility claim due to other rules involving facility billing and same-day procedures.
Regarding the use of one generic G-code to describe that a qualified CDSM was consulted, we are not confident that this would satisfy the statutory requirement under section 1834(q)(4)(B) of the Act to report which qualified CDSM was consulted. However, we may find that generic codes are needed as a temporary measure as we move forward with implementation.
If a CDSM is not consulted, for example due to the ordering professional attesting to a significant hardship, then we agree that a distinct G-code for that purpose is not necessary. Rather the modifier describing that hardship could be placed on the same claim line as the CPT code for the imaging service.
We agree with commenters that the issue of claims processing system resorting of claims information is problematic. When multiple imaging services are reported on a single claim, it will not be possible to pair the G-code describing which CDSM was consulted with the imaging service for which it was consulted. While we could require the furnishing professional to split the claim, we are not committing to that solution at this point but will explore that option as we move forward with implementation. Another possible
A few of these commenters stated that they requested this clarification because they noted: (1) Each qualified CDSM will know its G-code and can readily convert their adherence rating system into modifiers, (2) the required data could be transmitted between EHR and CDSM vendors and communicated between professionals in a standardized manner, and (3) accuracy of consultation reporting would improve.
Based on the public comments we are finalizing the proposal to use G-codes and modifiers to report consultation information on claims. We appreciate that commenters pointed out concerns and technical issues regarding this approach and we will work to address them during implementation.
We proposed to revise § 414.94(i)(3) of our regulations to adjust the significant hardship exception requirements under the AUC program. We proposed criteria specific to the AUC program and independent of other programs. An ordering professional experiencing any of the following when ordering an advanced diagnostic imaging service would not be required to consult AUC using a qualified CDSM, and the claim for the applicable imaging service would not be required to include AUC consultation information. The proposed criteria include:
• Insufficient internet access;
• EHR or CDSM vendor issues; or
• Extreme and uncontrollable circumstances.
Insufficient internet access is specific to the location where an advanced diagnostic imaging service is ordered by the ordering professional. EHR or CDSM vendor issues may include situations where ordering professionals experience temporary technical problems, installation or upgrades that temporarily impede access to the CDSM, vendors cease operations, or we de-qualify a CDSM. We expect these situations to generally be irregular and unusual. Extreme and uncontrollable circumstances include disasters, natural or man-made, that have a significant negative impact on healthcare operations, area infrastructure or communication systems. These could include areas where events occur that have been designated a federal Emergency Management Agency (FEMA) major disaster or a public health emergency declared by the Secretary. Based on 2016 data from the Medicare EHR Incentive Program and the 2019 payment year MIPS eligibility and special status file, we estimate that 6,699 eligible clinicians could submit such a request due to extreme and uncontrollable circumstances or as a result of a decertification of an EHR, which represents less than 1 percent of available ordering professionals.
In the CY 2017 PFS final rule, for purposes of the AUC program significant hardship exceptions, we provided that those who received significant hardship exceptions in the following categories from § 495.102(d)(4) would also qualify for significant hardship exceptions for the AUC program:
• Insufficient internet Connectivity (as specified in § 495.102(d)(4)(i)).
• Practicing for less than 2 years (as specified in § 495.102(d)(4)(ii)).
• Extreme and Uncontrollable Circumstances (as specified in § 495.102(d)(4)(iii)).
• Lack of Control over the Availability of CEHRT (as specified in § 495.102(d)(4)(iv)(A)).
• Lack of Face-to-Face Patient Interaction (as specified in § 495.102(d)(4)(iv)(B)).
In the CY 2018 PFS proposed rule, we proposed to amend the AUC significant hardship exception regulation to specify that ordering professionals who are granted reweighting of the Advancing Care Information (ACI) performance category to zero percent of the final score for the year under MIPS per § 414.1380(c)(2) due to circumstances that include the criteria listed in § 495.102(d)(4)(i), (d)(4)(iii), and (d)(4)(iv)(A) and (B) (as outlined in the bulleted list above) would be excepted from the AUC consultation requirement during the same year that the re-weighting applies for purposes of the MIPS payment adjustment. This proposal removed § 495.102(d)(4)(ii), practicing for less than 2 years, as a criterion since these clinicians are not MIPS eligible clinicians and thus would never meet the criteria for reweighting of their MIPS ACI performance category for the year.
In response to public comments, we did not finalize the proposed changes to the significant hardship exceptions in the CY 2018 PFS final rule and instead decided further evaluation was needed before moving forward with any modifications. Our original intention was to design the AUC significant hardship exception process in alignment with the process for the Medicare EHR Incentive Program for eligible professionals, and then for the MIPS ACI (now Promoting Interoperability) performance category. Under section 1848(a)(7)(A) of the Act, the downward payment adjustment for eligible professionals under the Medicare EHR Incentive Program will end in 2018, and we are unable to continue making reference to a regulation relating to a program that is no longer in effect. As we have continued to evaluate both policy options and operational considerations for the AUC significant hardship exception, we have concluded that the most appropriate approach, which we consider to be more straightforward and less burdensome than the current approach, involves establishing significant hardship criteria and a process that is independent from other Medicare programs. We also note as we have in the past that the AUC program is a real-time program with a need for real-time significant hardship exceptions. This is in contrast to the way significant hardship exceptions are handled under MIPS where the hardship might impact some or all of a performance period, or might impact reporting, both of which occur well before the MIPS payment adjustment is applied in a subsequent year. We recognize that when a significant hardship arises, an application process to qualify for an exception becomes a time consuming hurdle for health care providers to navigate, and we believe that it is important to minimize the burden involved in seeking significant hardship exceptions. As such, we proposed that ordering professionals would self-attest if they are experiencing a significant hardship at the time of placing an advanced diagnostic imaging order and such attestation would be supported with documentation of significant hardship. Ordering professionals attesting to a significant hardship would communicate that information to the furnishing professional with the order and it would be reflected on the furnishing professional's and furnishing facility's claim by appending a HCPCS modifier. The modifier would indicate that the ordering professional has self-attested to experiencing a significant hardship and communicated this to the furnishing professional with the order. Claims for advanced diagnostic imaging services that include a significant hardship exception modifier would not be required to include AUC consultation information.
In addition to the proposals above, we invited the public to comment on any
The following is a summary of the comments we received on the modifications to the significant hardship exceptions and additional circumstances for consideration as needing significant hardship exceptions.
We describe insufficient internet access as specific to the location where an advanced diagnostic imaging service is ordered by the ordering professional. To further clarify, we note that in addition to ordering imaging services in an area without sufficient internet access, a significant hardship may apply when ordering professionals would face insurmountable barriers to obtaining infrastructure to have internet access (that is, lack of broadband). We do not believe that occasions of slow internet constitute a significant hardship.
We describe EHR or CDSM vendor issues as situations where ordering professionals experience temporary technical problems, installation or upgrades that temporarily impede access to the CDSM, vendors cease operations, or we de-qualify a CDSM and note that we expect these situations to be irregular and unusual. De-certification of an EHR would qualify as a significant hardship when the ordering professionals' qualified CDSM is integrated into their EHR, and the ordering professional's access to the CDSM is temporarily impeded due to installation issues associated with switching to a new vendor. We do not agree that losing CDSM usernames and passwords constitutes a significant hardship under the AUC program. Self-attestation for this significant hardship should be used as needed when the situations described above occur. We have not established limitations around using the EHR or CDSM vendor issues or the other significant hardship exceptions, but may monitor the use of these exceptions to ensure misuse or overuse does not become a problem.
We describe extreme and uncontrollable circumstances to include disasters, natural or man-made, that have a significant negative impact on healthcare operations, area infrastructure or communication systems. We also explain these may include areas where events occur that have been designated by FEMA as a major disaster or a public health emergency declared by the Secretary. To further clarify, these circumstances are events that are entirely outside the control of the ordering professional that prevent the ordering professional from consulting AUC through a qualified CDSM. We believe the hardship criteria under this program are similar to other programs such as MIPS and Promoting Interoperability, particularly the flexibility that is given to clinicians to identify extreme and uncontrollable circumstances.
After considering the public comments, we are finalizing the significant hardship categories of insufficient internet access, EHR or CDSM vendor issues, and extreme and uncontrollable circumstances and updating this language in § 414.94(i)(3) of our regulations. We are also finalizing our proposal to allow ordering professionals experiencing a significant hardship to self-attest and include that information on the order for the advanced diagnostic imaging service, which the furnishing professional or facility would then communicate on the Medicare claim for the service by appending a HCPCS modifier identifying the ordering professional's self-attested significant hardship category.
As previously mentioned, the fourth component of the AUC program specified in section 1834(q)(5) of the Act, is the identification of outlier ordering professionals. In our efforts to start a dialogue with stakeholders, we invited the public to submit their ideas on a possible methodology for the identification of outlier ordering professionals who would eventually be subject to a prior authorization process when ordering advanced diagnostic imaging services. Specifically, we solicited comments on the data elements and thresholds that we should consider when identifying outliers. We also intend to perform and use analysis to assist us in developing the outlier methodology for the AUC program. Our existing prior authorization programs generally do not specifically focus on outliers. We are interested in hearing ideas from the public on how outliers could be determined for the AUC program. Because we would be concerned about data integrity and reliability, we do not intend to include data from the educational and operations testing period in CY 2020 in the analysis used to develop our outlier methodology. Since we intend to evaluate claims data to inform our methodology we expect to address outlier identification and prior authorization more fully in CY 2022 or 2023 rulemaking. We appreciate the feedback received from public commenters and as noted above, we
We appreciate the commenters that continue to provide their perspective and feedback on this program. Based on those comments we will finalize the following:
We will finalize as proposed to add IDTFs to the definition of applicable settings under § 414.94(b) of this program. We will also finalize as proposed that furnishing professionals and all furnishing entities are required to report AUC consultation information on the claim as specified under § 414.94(k). In addition we will finalize as proposed the significant hardship exception criteria and process under § 414.94(i)(3) to be specific to the AUC program and independent of other Medicare programs.
We will not finalize as proposed the proposal to allow the AUC consultation, when not personally performed by the ordering professional, to be performed by auxiliary personnel incident to the ordering professional's services. Rather we are finalizing under § 414.94(j)(2) that when delegated by the ordering professional, clinical staff under the direction of the ordering professional may perform the AUC consultation with a qualified CDSM.
Additionally, we will move forward with plans to use G-codes and modifiers to report AUC consultation information on the Medicare claims.
We will continue to post information on our website for this program, accessible at
Sections 1903(a)(3)(F) and 1903(t) of the Act provide the statutory basis for the incentive payments made to Medicaid EPs and eligible hospitals for the adoption, implementation, upgrade, and meaningful use of CEHRT. We have implemented these statutory provisions in prior rulemakings to establish the Medicaid Promoting Interoperability Program.
Under sections 1848(o)(2)(A)(iii) and 1903(t)(6)(C)(i)(II) of the Act, and the definition of “meaningful EHR user” in regulations at § 495.4, one of the requirements of being a meaningful EHR user is to successfully report the clinical quality measures selected by CMS to CMS or a state, as applicable, in the form and manner specified by CMS or the state, as applicable. Section 1848(o)(2)(B)(iii) of the Act requires that in selecting electronic clinical quality measures (eCQMs) for EPs to report under the Promoting Interoperability Program, and in establishing the form and manner of reporting, the Secretary shall seek to avoid redundant or duplicative reporting otherwise required. We have taken steps to align various quality reporting and payment programs that include the submission of eCQMs.
In the “Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2018 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Program Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Provider-Based Status of Indian Health Service and Tribal Facilities and Organizations; Costs Reporting and Provider Requirements; Agreement Termination Notices” final rule (82 FR 37990, 38487) (hereafter referred to as the “FY 2018 IPPS/LTCH PPS final rule”), we established that, for 2017, Medicaid EPs would be required to report on any six eCQMs that are relevant to the EP's scope of practice. In proposing and finalizing that change, we indicated that it is our intention to align eCQM requirements for Medicaid EPs with the requirements of Medicare quality improvement programs, to the extent practicable.
CMS annually reviews and revises the list of eCQMs for each MIPS performance year to reflect updated clinical standards and guidelines. In section III.I.3.h.(2)(b)(i) of this final rule, we amend the list of available eCQMs for the CY 2019 performance period. To keep eCQM specifications current and minimize complexity, we proposed to align the eCQMs available for Medicaid EPs in 2019 with those available for MIPS eligible clinicians for the CY 2019 performance period (83 FR 35871). Specifically, we proposed that the eCQMs available for Medicaid EPs in 2019 would consist of the list of quality measures available under the eCQM collection type on the final list of quality measures established under MIPS for the CY 2019 performance period.
We explained that we believed that this proposal would be responsive to stakeholder feedback supporting quality measure alignment between MIPS and the Medicaid Promoting Interoperability Program for EPs, and that it would encourage EP participation in the Medicaid Promoting Interoperability Program by allowing those that are also MIPS eligible clinicians the ability to report the same eCQMs as they report for MIPS in 2019. In addition, we explained that we believed that aligning the eCQMs available in each program would ensure the most uniform application of up-to-date clinical standards and guidelines possible.
We explained that we anticipated that this proposal would reduce burden for Medicaid EPs by aligning the requirements for multiple reporting programs, and that the system changes required for EPs to implement this change would not be significant, particularly in light of our belief that many EPs will report eCQMs to meet the quality performance category of MIPS and therefore should be prepared to report on the available eCQMs for 2019. We explained that we expected that this proposal would have only a minimal impact on states, by requiring minor adjustments to state systems for 2019 to maintain current eCQM lists and specifications.
We also requested comments on whether in future years of the Medicaid Promoting Interoperability Program beyond 2019, we should include all e-specified measures from the core set of quality measures for Medicaid and the Children's Health Insurance Program (CHIP) (the Child Core Set) and the core set of health care quality measures for adults enrolled in Medicaid (Adult Core Set) (hereinafter together referred to as “Core Sets”) as additional options for Medicaid EPs.
Sections 1139A and 1139B of the Act require the Secretary to identify and publish core sets of health care quality measures for child Medicaid and CHIP beneficiaries and adult Medicaid beneficiaries. These measure sets are required by statute to be updated annually and are voluntarily reported by states to CMS. These core sets comprise measures that specifically focus on populations served by the Medicaid and CHIP programs and are of particular importance to their care. Several of these Core Set measures are included in the MIPS eCQM list, but some are not. We explained that we believe that including, as eCQM reporting options for Medicaid EPs, the e-specified measures from the Core Sets that are not
For 2019, we proposed that Medicaid EPs would report on any six eCQMs that are relevant to their scope of practice, regardless of whether they report via attestation or electronically. After we removed the NQS domain requirements for Medicaid EPs' 2017 eCQM submissions in the FY 2018 IPPS/LTCH PPS final rule, we have found that allowing EPs to report on any six quality measures that are relevant to their practice has increased EPs' flexibility to report pertinent data. In addition, this policy of allowing Medicaid EPs to report on any six measures relevant to their scope of practice would generally align with the MIPS data submission requirement for eligible clinicians using the eCQM collection type for the quality performance category, which is established at § 414.1335(a)(1). MIPS eligible clinicians who elect to submit eCQMs must generally submit data on at least six quality measures, including at least one outcome measure (or, if an applicable outcome measure is not available, one other high priority measure). We refer readers to § 414.1335(a) for the data submission criteria that apply to individual MIPS eligible clinicians and groups that elect to submit data with other collection types.
We proposed that for 2019 the Medicaid Promoting Interoperability Program would adopt the MIPS requirement that EPs report on at least one outcome measure (or, if an outcome measure is not available or relevant, one other high priority measure).
We also requested comments on how high priority measures should be identified for Medicaid EPs. We proposed (83 FR 35872) to use all three of the following methods to identify which of the available measures are high priority measures, but invited comments on other possibilities.
1. We proposed to use the same set of high priority measures for EPs participating in the Medicaid Promoting Interoperability Program that the MIPS program has identified for eligible clinicians. As discussed in section III.I.3.h.(2)(b)(i) of this final rule, we proposed to amend § 414.1305 to revise the definition of high priority measure for purposes of MIPS to mean an outcome (including intermediate-outcome and patient-reported outcome), appropriate use, patient safety, efficiency, patient experience, care coordination, or opioid-related quality measure, beginning with the 2021 MIPS payment year.
2. For 2019, we also proposed to identify as high priority measures the available eCQMs that are included in the previous year's Core Sets and that are also included on the MIPS list of eCQMs. We explained that because the Core Sets are released at the beginning of each year, it would not be possible to update the list of high-priority eCQMs with those added to the current year's Core Sets. We also explained that CMS has already identified the measures included in the Core Sets as ones that specifically focus on populations served by the Medicaid and CHIP programs and are particularly important to their care. The eCQMs that would be available for Medicaid EPs to report in 2019, that are both part of the Core Sets and on the MIPS list of eCQMs, and that would be considered high priority measures under our proposal are: CMS2, “Preventive Care and Screening: Screening for Depression and Follow-Up Plan”; CMS4, “Initiation and Engagement of Alcohol and Other Drug Dependence Treatment”; CMS122, “Diabetes: Hemoglobin A1c (HbA1c) Poor Control (>9%)”; CMS125, “Breast Cancer Screening”; CMS128, “Anti-depressant Medication Management”; CMS136, “Follow-Up Care for Children Prescribed ADHD Medication (ADD)”; CMS153, “Chlamydia Screening for Women”; CMS155, “Weight Assessment and Counseling for Nutrition and Physical Activity for Children and Adolescents”; and CMS165, “Controlling High Blood Pressure.”
3. We also proposed to give each state the flexibility to identify which of the available eCQMs selected by CMS are high priority measures for Medicaid EPs in that state, with review and approval from CMS, through their State Medicaid HIT Plans (SMHP), similar to the flexibility granted states to modify the definition of Meaningful Use at § 495.332(f). We explained that we believe this proposal would give states the ability to identify as high priority those measures that align with their state health goals or other programs within the state. We proposed to amend § 495.332(f) to provide for this state flexibility to identify high priority measures.
We proposed that any eCQMs identified via any of these mechanisms be considered to be high priority measures for EPs participating in the Medicaid Promoting Interoperability Program for 2019.
We also proposed that the eCQM reporting period for EPs in the Medicaid Promoting Interoperability Program would be a full CY in 2019 for EPs who have demonstrated meaningful use in a prior year, in order to align with the corresponding performance period in MIPS for the quality performance category. We explained that we continue to align Medicaid Promoting Interoperability Program requirements with requirements for other CMS quality programs, such as MIPS, to the extent practicable, to reduce the burden of reporting different data for separate programs. In addition, we explained that we have found that clinical quality data from an entire year reporting period is significantly more useful than partial year data for quality measurement and improvement because it gives states a fuller picture of a health care provider's care and patient outcomes. We proposed that the eCQM reporting period for Medicaid EPs demonstrating meaningful use for the first time, which was established in the final rule entitled “Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 3 and Modifications to Meaningful Use in 2015 Through 2017” (80 FR 62762) (hereafter referred to as “Stage 3 final rule”), would remain any continuous 90-day period (80 FR 62892).
We explained that we will adjust future years' requirements for reporting eCQMs in the Medicaid Promoting Interoperability Program through rulemaking, and will continue to align the quality reporting requirements, as logical and feasible, to minimize EP burden.
After careful consideration of the comments, we are finalizing without change our proposal to amend the list of available eCQMs for the CY 2019 performance period. To keep eCQM specifications current and minimize complexity, we are aligning the eCQMs available for Medicaid EPs in 2019 with those available for MIPS eligible clinicians for the CY 2019 performance period. Specifically, the eCQMs available for Medicaid EPs in 2019 will consist of the list of quality measures available under the eCQM collection type on the final list of quality measures established under MIPS for the CY 2019 performance period.
We did not propose to include the e-specified measures within the Adult Core Set and Child Core Set that are not also on the MIPS eCQM list for eCQM reporting in the Medicaid Promoting Interoperability Program in 2019, due to timing and logistical feasibility. However, we intend to reevaluate whether to add these measures when proposing eCQM reporting requirements for the Medicaid Promoting Interoperability Program for 2020 and beyond.
After careful consideration of the comments, we are finalizing our
Finally, this proposal should not increase burden on CEHRT vendors. States may select high priority measures only from the list of eCQMs that are already available for Medicaid EPs to meet the requirements of the program. Medicaid EPs are not required to select any of their state-specific high priority measures. Therefore, the CEHRT need not vary between states, but must be able to calculate and report on at least one outcome measure (or, if an applicable outcome measure is not available or relevant, one other high priority measure) relevant to the provider's scope of practice, whether or not that is a state-specific high priority measure.
We received no comments on the first and second methods of identifying high priority measures for the Medicaid Promoting Interoperability Program. After careful consideration of the comments on our proposed approach to how high priority measures would be identified, we are finalizing it without modification.
After careful consideration of the comments, we are finalizing without change our proposal that the eCQM reporting period for EPs in the Medicaid Promoting Interoperability Program will be a full CY in 2019 for EPs who have demonstrated meaningful use in a prior year, in order to align with the corresponding performance period in MIPS for the quality performance category. The eCQM reporting period for Medicaid EPs demonstrating meaningful use for the first time, which was established in the Stage 3 final rule, will remain any continuous 90-day period (80 FR 62892).
In the July 28, 2010 final rule titled “Medicare and Medicaid Programs; Electronic Health Record Incentive Program” at 75 FR 44319, we established that, in accordance with section 1903(t)(4)(A)(iii) of the Act, in no case may any Medicaid EP receive an incentive after 2021 (see § 495.310(a)(2)(v)). Therefore, December 31, 2021 is the last date that states could make Medicaid Promoting Interoperability Program payments to Medicaid EPs (other than pursuant to a successful appeal related to 2021 or a prior year).
For states to make payments by that deadline, there must be sufficient time after EHR and eCQM reporting periods end for Medicaid EPs to attest to states, for states to conduct their prepayment processes, and for states to issue payments. Therefore, we proposed to amend § 495.4 to provide that the EHR reporting period in 2021 for all EPs in the Medicaid Promoting Interoperability Program would be a minimum of any continuous 90-day period within CY 2021, provided that the end date for this period falls before October 31, 2021, to help ensure that the state can issue all Medicaid Promoting Interoperability Program payments on or before December 31, 2021. Similarly, we proposed to change the eCQM reporting period in 2021 for EPs in the Medicaid Promoting Interoperability Program to a minimum of any continuous 90-day period within CY 2021, provided that the end date for this period falls before October 31, 2021, to help ensure that the state can issue all Medicaid Promoting Interoperability Program payments on or before December 31, 2021.
We explained that we understand that the October 31, 2021 date might not provide some states with sufficient time to process payments by December 31,
We believe there is no reason why a state would need to set a date by which EHR reporting periods and eCQM reporting periods must end for Medicaid EPs that is earlier than the day before that state's attestation deadline for EPs. Doing so would restrict Medicaid EPs' ability to select EHR and eCQM reporting periods. Therefore, we proposed that any alternative deadline for CY 2021 EHR and eCQM reporting periods set by a state may not be any earlier than the day prior to the attestation deadline for Medicaid EPs attesting to that state.
The following is a summary of the comments we received regarding these proposals.
After careful consideration of the comments, we are finalizing our proposal to amend § 495.4 to provide that the EHR reporting period in 2021 for all EPs in the Medicaid Promoting Interoperability Program will be a minimum of any continuous 90-day period within CY 2021, provided that the end date for this period falls before October 31, 2021, to help ensure that states can issue all Medicaid Promoting Interoperability Program payments on or before December 31, 2021. We are also finalizing our proposal to change the eCQM reporting period in 2021 for EPs in the Medicaid Promoting Interoperability Program to a minimum of any continuous 90-day period within CY 2021, provided that the end date for this period falls before October 31, 2021, to help ensure that states can issue all Medicaid Promoting Interoperability Program payments on or before December 31, 2021.
In addition, we are finalizing our proposal to allow states the flexibility to set alternative, earlier final deadlines for EHR or eCQM reporting periods for Medicaid EPs in CY 2021, with prior approval from us, through their State Medicaid HIT Plan (SMHP). Any alternative deadline for CY 2021 EHR and eCQM reporting periods set by a state may not be any earlier than the day prior to the attestation deadline for Medicaid EPs attesting to that state.
Although we did not address reporting periods in 2021 for eligible hospitals in the proposed rule, we acknowledge that there will be a similar issue if there are still hospitals eligible to receive Medicaid Promoting Interoperability Program payments in 2021, including Medicaid-only eligible hospitals as well as “dually-eligible” eligible hospitals and critical access hospitals (CAHs) (those that are eligible for an incentive payment under Medicare for meaningful use of CEHRT and/or subject to the Medicare payment reduction for failing to demonstrate meaningful use of CEHRT, and are also eligible to earn a Medicaid incentive payment for meaningful use of CEHRT). However, based on attestation data and information from states' SMHPs regarding the number of years states disburse Medicaid Promoting Interoperability Program payments to hospitals, we believe that there will be no hospitals eligible to receive Medicaid Promoting Interoperability Program payments in 2021 due to the requirement that, after 2016, eligible hospitals cannot receive a Medicaid Promoting Interoperability Program payment unless they have received such a payment in the prior fiscal year. At this time, we believe that there are no hospitals that will be able to receive incentive payments in 2020 or 2021. We invited comments and suggestions on whether this belief is accurate, and if not, how we could address the issue in a manner that limits the burden on hospitals and states. The following is a summary of the comments we received on this issue.
We did not propose any specific policy regarding eligible hospital reporting periods for 2021 in this rule and thus are not finalizing any policy in this area now, but we expect to solicit additional comment on the issue in a future proposed rule that is more specifically related to hospital payment.
In the Stage 3 final rule, we adopted a phased approach under Stage 3 for EP Objective 6 (Coordination of care through patient engagement), Measure 1 (View, Download, or Transmit) and Measure 2 (Secure Electronic Messaging). This phased approach established a 5 percent threshold for both measures 1 and 2 of this objective for an EHR reporting period in 2017. (80 FR 62848 through 62849) In the same rule, we established that the threshold for Measure 1 would rise to 10 percent, beginning with the EHR reporting period in 2018, and that the threshold for Measure 2 would rise to 25 percent, beginning with the EHR reporting period in 2018. We stated that we would continue to monitor performance on these measures to determine if any further adjustment was needed. In the FY 2018 IPPS/LTCH PPS final rule (82 FR 38493), we established a policy allowing EPs, eligible hospitals, and CAHs to use either 2014 Edition or 2015 Edition CEHRT, or a combination of 2014 Edition and 2015 Edition CEHRT, for an EHR reporting period in CY 2018, and depending on which Edition(s) they use, to attest to the Modified Stage 2 objectives and measures or the Stage 3 objectives and measures. In doing so, we also delayed the rise of the Objective 6 Measure 1 and Measure 2 thresholds until 2019.
We explained that based on feedback we have received, we understand that these two measures are the largest barrier to successfully demonstrating meaningful use, especially in rural areas and at safety net clinics. Stakeholders have reported a variety of causes that have resulted in lower patient participation than was anticipated when the Stage 3 final rule was issued. The data that we have collected via states for Medicaid EPs and at CMS from Medicare EPs for previous program years support this feedback. The primary issue is that the view, download, transmit measure requires a positive action by patients, which cannot be controlled by an EP. Medicaid populations that are at the greatest risk have lower levels of internet access, internet literacy and health literacy than the general population. Although the Secure Electronic Messaging measure does not require patient action, only that the EP send a secure message, we have received feedback that this functionality is not highly utilized by patients. Although we encourage Medicaid EPs to continue to reach out to patients via secure messaging to engage them in their health care between office visits, it is not productive for EPs to send messages to patients who are unlikely to see them or take action. Retaining the current threshold of 5 percent for both measures would continue to incentivize Medicaid EPs to engage patients in their own care without raising the requirements to unattainable thresholds for EPs who serve vulnerable Medicaid patients. Therefore, we proposed to amend § 495.24(d)(6)(i) such that the thresholds for Measure 1 (View, Download, or Transmit) and Measure 2 (Secure Electronic Messaging) of Meaningful Use Stage 3 EP Objective 6 (Coordination of care through patient engagement) would remain 5 percent for 2019 and subsequent years.
The following is a summary of the comments we received on this proposal.
In addition, we note that the change from the Modified Stage 2 objectives and measures will make this objective easier for Medicaid EPs to meet. There are three measures under “Objective 6: Coordination of Care through Patient Engagement.” To be a meaningful EHR user, an EP must attest to all three measures, but only meet the thresholds for two of those three. Under Modified Stage 2, both Measure 1 (View, Download, or Transmit) and Measure 2 (Secure Electronic Messaging) were required (but not under the same objective) and Measure 3 was not an option. Both Measure 2 and Measure 3 do not rely on any patient action, but only require Medicaid EPs' action.
After reviewing the comments, we are finalizing without change the proposal to amend § 495.24(d)(6)(i) so that the thresholds for Measure 1 (View, Download, or Transmit) and Measure 2 (Secure Electronic Messaging) of Meaningful Use Stage 3 EP Objective 6 (Coordination of care through patient engagement) will remain 5 percent for 2019 and subsequent years.
In the proposed rule, we explained that in the Stage 3 final rule, we established that the syndromic surveillance reporting measure for EPs was limited to those who practice in urgent care settings (80 FR 62866 through 62870). Since then, we have received feedback from states and public health agencies that while many are unable to accept non-emergency or non-urgent care ambulatory syndromic surveillance data electronically, some public health agencies can and do want to receive data from health care providers in non-urgent care settings. We also explained that we believe that public health agencies that set the requirements for data submission to public health registries are in a better position to judge which health care providers can contribute useful data.
Therefore, we proposed to amend § 495.24(d)(8)(i)(B)(
The following is a summary of the comments we received on this proposal.
After careful consideration of the comments, we are finalizing without change our proposal to amend § 495.24(d)(8)(i)(B)(
As required under section 1899 of the Act, we established the Medicare Shared Savings Program (Shared Savings Program) to facilitate coordination and cooperation among health care providers to improve the quality of care for Medicare fee-for-service (FFS) beneficiaries and reduce the rate of growth in expenditures under Medicare Parts A and B. Eligible groups of providers and suppliers, including physicians, hospitals, and other health care providers, may participate in the Shared Savings Program by forming or participating in an Accountable Care Organization (ACO). The final rule establishing the Shared Savings Program appeared in the November 2, 2011
In August 2018, we issued the “Medicare Program: Medicare Shared Savings Program; Accountable Care Organizations—Pathways to Success” proposed rule (hereinafter referred to as the “August 2018 proposed rule”) which addressed a number of proposed policy changes including redesign of the participation options available under the program to encourage ACOs to transition to two-sided models; new tools to support coordination of care across settings and strengthen beneficiary engagement; revisions to ensure rigorous benchmarking; and policies promoting use of interoperable electronic health record technology among ACO providers/suppliers (83 FR 41786). In section V. of this final rule, we are finalizing the following proposals from the August 2018 proposed rule:
• A voluntary 6-month extension for existing ACOs whose participation agreements expire on December 31, 2018 and the methodology for determining financial and quality performance for this 6-month performance year from January 1, 2019, through June 30, 2019;
• Policies implementing the Bipartisan Budget Act of 2018 provisions on voluntary alignment;
• Modifications to the definition of primary care services used in assigning beneficiaries to ACOs to reflect recent code changes;
• Extension of policies providing relief for ACOs and their clinicians impacted by extreme and uncontrollable circumstances during 2017 to performance year 2018 and subsequent years; and
• Policies to promote interoperability among ACO providers/suppliers, including establishing a new program eligibility requirement regarding CEHRT use and retiring the CEHRT quality measure (ACO-11).
We expect to address the remaining proposals in the August 2018 proposed rule in a forthcoming final rule.
We have also made use of the annual calendar year (CY) PFS rules to address quality reporting for the Shared Savings Program and certain other issues. In the CY 2018 PFS final rule (82 FR 53209 through 53226), we finalized revisions to several different policies under the
As a general summary, in the CY 2019 PFS proposed rule, we proposed the following changes to the quality performance measures that will be used to assess quality performance under the Shared Savings Program for performance year 2019 and subsequent years:
• Changes to Patient Experience of Care Survey measures.
• Changes to CMS Web Interface and Claims-Based measures.
In addition, in the August 2018 proposed rule, we proposed another change to the Shared Savings Program quality measure set, which we are finalizing in section V.B.2.f. of this final rule. We proposed to remove the ACO-11—
Section 1899(b)(3)(C) of the Act states that the Secretary shall establish quality performance standards to assess the quality of care furnished by ACOs and seek to improve the quality of care furnished by ACOs over time by specifying higher standards, new measures, or both. In the November 2011 final rule, we established a quality measure set spanning four domains: Patient experience of care, care coordination/patient safety, preventive health, and at-risk population (76 FR 67872 through 67891). Since the Shared Savings Program was established, we have updated the measures that comprise the quality performance measure set for the Shared Savings Program through the annual rulemaking in the CY 2015, 2016, and 2017 PFS final rules (79 FR 67907 through 67920, 80 FR 71263 through 71268, and 81 FR 80484 through 80489, respectively).
As we stated in the November 2011 final rule establishing the Shared Savings Program (76 FR 67872), our principal goal in selecting quality measures for ACOs has been to identify measures of success in the delivery of high-quality health care at the individual and population levels, with a focus on outcomes. For performance year 2018, 31 quality measures will be used to determine ACO quality performance (81 FR 80488 and 80489). The information used to determine ACO performance on these quality measures will be submitted by the ACO through the CMS Web Interface, submitted by ACO participant TINs to MIPS for the Promoting Interoperability (PI) performance category (formerly Advancing Care Information), calculated by CMS from administrative claims data, and collected via a patient experience of care survey referred to as the Consumer Assessment of Healthcare Provider and Systems (CAHPS) for ACOs Survey. The CAHPS for ACOs survey is based on the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Survey and includes additional, program specific questions that are not part of the CG-CAHPS. The CG-CAHPS survey is maintained, and periodically updated, by the Agency for Healthcare Research and Quality (AHRQ) in HHS.
The quality measures collected through the CMS Web Interface in 2015 and 2016 were used to determine whether eligible professionals participating in an ACO would avoid the PQRS and automatic Physician Value-Based Payment Modifier (Value Modifier) downward payment adjustments for 2017 and 2018 and to determine if ACO participants were eligible for upward, neutral or downward adjustments based on quality measure performance under the Value Modifier. Beginning with the 2017 performance period, which impacts payments in 2019, PQRS and the Value Modifier were replaced by the MIPS. Eligible clinicians who are participating in an ACO and who are subject to MIPS (MIPS eligible clinicians) will be scored under the APM scoring standard under MIPS (81 FR 77260). These MIPS eligible clinicians include any eligible clinicians who are participating in an ACO in a track of the Shared Savings Program that is not an Advanced APM, as well as those participating in an ACO in a track that is an Advanced APM, but who do not become Qualifying APM Participants (QPs) as specified in § 414.1425, and are not otherwise excluded from MIPS. Beginning with the 2017 reporting period, measures collected through the CMS Web Interface will be used to determine the MIPS quality performance category score for MIPS eligible clinicians participating in a Shared Savings Program ACO. Starting with the 2018 performance period, the quality performance category under the MIPS APM Scoring Standard for MIPS eligible clinicians participating in a Shared Savings Program ACO will include measures collected through the CMS Web Interface and the CAHPS for ACOs survey measures.
The CAHPS for ACOs Survey includes the core questions contained in the CG-CAHPS, plus additional questions to measure access to and use of specialist care, experience with care coordination, patient involvement in decision-making, experiences with a health care team, health promotion and patient education, patient functional status, and general health. The 2018 CAHPS for ACOs Survey 3.0 incorporates updates made by AHRQ to the CG-CAHPS survey based on feedback from survey users and stakeholders, as well as analyses of multiple data sets. For a summary of the history of changes to the CAHPS for ACOs survey, please refer to the CY 2019 PFS proposed rule (83 FR 35875). Additional information on the CG-CAHPS survey update is available on the AHRQ website at
In addition to incorporating changes based on the AHRQ survey update, CMS removed all items included in the
To enhance the Patient/Caregiver Experience domain and align with MIPS (82 FR 54163), we proposed to begin scoring the 2 SSMs that are currently collected with the administration of the CAHPS for ACOs survey and shared with the ACOs for informational purposes only. Under this proposal, we would add the following CAHPS for ACOs SSMs that are already collected and provided to ACOs for informational purposes to the quality measure set for the Shared Savings Program as ACO-45,
The Courteous and Helpful Office Staff SSM, which we proposed to add as ACO-45, asks about the helpfulness, courtesy and respectfulness of office staff. This SSM has been a CG-CAHPS core measure in the previous two versions of the CG-CAHPS survey, but was previously provided for informational purposes only and not included in the ACO quality score determination. We also proposed to add the SSM,
Including these measures in the quality measure set that is used to assess the quality performance of ACOs under the Shared Savings Program would place greater emphasis on outcome measures and the voice of the patient and provide ACOs with an additional incentive to act upon opportunities for improved care coordination and communication, and would align with the MIPS measure set finalized in the CY 2018 Quality Payment Program final rule (82 FR 54163). Care Coordination and patient and caregiver engagement are goals of the Shared Savings Program. The Care Coordination SSM emphasizes the care coordination goal, while the Courteous and Helpful Office Staff SSM supports patient engagement as it addresses a topic that has been identified as important to beneficiaries in testing. For performance year 2016, the mean performance rates across all ACOs for these two measures, which were not included in the ACO quality score determination, were 87.18 for the Care Coordination SSM and 92.12 for Courteous and Helpful Office Staff SSM.
Consistent with § 425.502(a)(4), regarding the scoring of newly introduced quality measures, we proposed that these additional SSMs would be pay-for-reporting for all ACOs for 2 years (performance years 2019 and 2020). The measures would then phase into pay-for-performance in the program, according to the schedule in Table 26 beginning in performance year 2021. We solicited comment on this proposed change to the quality measure set.
The following is a summary of the comments we received on this proposed change to the CAHPS measures included in the Shared Savings Program quality measure set.
With regard to the comment supporting the intent of our proposal to start scoring performance on the Courteous and Helpful Office Staff measure, but stating that it is unnecessary to add a measure with a high average performance rate, we believe that this is an important area for continued measurement as beneficiaries have expressed its importance to them in testing, as noted previously. In addition, we believe it is important to continue monitoring this measure because it is an important factor in patient experience of care. By scoring this measure, we acknowledge its continued importance as a patient experience measure. With regard to the comment that we consider expanding ACO-45 to include medical assistants and nurses, we will take this comment under consideration for further analysis as part of any potential future measure refinement.
After considering the comments, we are finalizing our proposal to begin scoring ACO-45 and ACO-46 as part of the CAHPS for ACO survey beginning with quality reporting for performance years during 2019. Consistent with our existing policy regarding the scoring of newly introduced quality measures, these additional SSMs will be pay-for-reporting for all ACOs for 2 years (performance years during 2019 and performance year 2020). The measures would then phase into pay-for-performance beginning in performance year 2021 (§ 425.502(a)(4)). The phase-in schedule for the 2019 ACO quality measures set that we are finalizing in this rule is presented in Table 26.
Additionally, we solicited comment on potentially converting the Health and Functional Status SSM (ACO-7) to pay-for-performance in the future. The Health and Functional Status SSM is currently pay-for-reporting for all years. We have not scored this measure because the scores on the Health and Functional Status SSM may reflect the underlying health of beneficiaries seen by ACO providers/suppliers as opposed to the quality of the care provided by the ACO. We also sought stakeholder feedback on possible options for enhancing the collection of health and functional status data, including potentially changing our data collection procedures to collect data from the same ACO's assigned beneficiaries over time. We noted that such a change could allow for measurement of functional status changes that occurred while beneficiaries were receiving care from ACO providers/suppliers. We also solicited other recommendations regarding the potential inclusion of a functional status measure in the assessment of ACO quality performance in the future.
The following is a summary of the comments we received regarding potentially converting the Health and Functional Status SSM (ACO-7) to pay-for-performance in the future.
In developing the proposals we made in the CY 2019 PFS proposed rule, we considered the agency's efforts to streamline quality measures, reduce regulatory burden and promote innovation as part of the agency's Meaningful Measures initiative (
Since the Shared Savings Program was first established in 2012, we have updated the quality measure set to reduce reporting burden and focus on more meaningful, outcome-based measures. The most recent updates to the Shared Savings Program quality measure set were made in the CY 2017 PFS final rule (81 FR 80484 through 80489) to adopt the ACO measure recommendations made by the Core Quality Measures Collaborative, a multi-stakeholder group with the goal of aligning quality measures for reporting across public and private initiatives to reduce provider reporting burden. Currently, more than half of the 31 Shared Savings Program quality measures are outcome-based, including:
• Patient-reported outcome measures collected through the CAHPS for ACOs Survey that strengthen patient and caregiver experience.
• Outcome measures supporting effective communication and care coordination, such as unplanned admission and readmission measures.
• Intermediate outcome measures that address the effective treatment of chronic disease, such as hemoglobin A1c control for patients with diabetes.
In the CY 2019 PFS proposed rule, we proposed to reduce the total number of measures in the Shared Savings Program quality measure set. The proposals were intended to reduce the burden on ACOs and their participating providers and suppliers by lowering the number of measures they are required to report through the CMS Web Interface and on which they are assessed using claims data. Reducing the number of measures on which ACOs are assessed would reduce the number of performance metrics that they are required to track and eliminate redundancies between measures that target similar populations. The proposed reduction in the number of measures would enable ACOs to better utilize their resources toward improving patient care. The proposed reduction in the number of measures would further reduce burden by aligning with the proposed changes to the CMS Web Interface measures that are reported under MIPS as discussed in Tables A, C, and D of Appendix 1: Proposed MIPS Quality Measures of the proposed rule. We recognize that ACOs and their participating providers and suppliers dedicate resources to performing well on our quality metrics, and we believe that reducing the number of metrics and aligning them across programs would allow them to more effectively target those resources toward improving patient care. We proposed to reduce the number of measures by minimizing measure overlap and eliminating several process measures. The proposal to remove process measures also aligns with our proposal to reduce the number of process measures within the MIPS measure set as discussed in section III.H.b.iii of this final rule and would support the CMS goal of moving toward outcome-based measurement.
We proposed to retire the following claims-based quality measures, which have a high degree of overlap with other measures that would remain in the measure set:
• ACO-35—Skilled Nursing Facility 30-Day All-Cause Readmission Measure (SNFRM).
• ACO-36—All-Cause Unplanned Admissions for Patients with Diabetes.
• ACO-37—All-Cause Unplanned Admission for Patients with Heart Failure.
Within the claims-based quality measures, a high degree of overlap exists between measures with respect to the population being measured (the denominator), because a single admission may be counted in multiple measures. For example, ACO-35 addresses unplanned readmissions from a SNF, and the vast majority of these SNF readmissions are also captured in the numerator of ACO-8 Risk-Standardized All Condition Readmission. Similarly, ACO-36 and ACO-37 address unplanned admissions for patients with diabetes and heart failure and most of these admissions are captured in the numerator of ACO-38
We also proposed to retire claims-based measure ACO-44—
We welcomed public comment on our proposal to retire these 4 claims-based measures from the quality measure set.
The following is a summary of the comments we received on our proposal to retire ACO-35—
After considering the comments, we are finalizing our proposal to remove ACO-35—
The following is a summary of the comments we received on our proposal to retire ACO-44—
After considering the comments, we are finalizing our proposal to remove ACO-44 from the Shared Savings Program quality measure set effective for quality reporting for performance years during 2019.
Although we proposed to retire ACO-35
The following is a summary of the comments we received on the possibility of adding the SNFQRP measure “Potentially Preventable 30-Day Post-Discharge Readmission Measure for Skilled Nursing Facilities”
Further, as we stated in the CY 2019 PFS proposed rule (83 FR 35877), we seek to align with changes made to the CMS Web Interface measures under the Quality Payment Program. In the 2017 PFS final rule, we stated that we do not believe it is beneficial to propose CMS Web interface measures for ACO quality reporting separately (81 FR 80499). Therefore, in order to avoid confusion and duplicative rulemaking, we adopted a policy that any future changes to the CMS Web interface measures would be proposed and finalized through rulemaking for the Quality Payment Program, and that such changes would be applicable to ACO quality reporting under the Shared Savings Program. In accordance with the policy adopted in the CY 2017 PFS final rule (81 FR 80501), we did not make any specific proposals related to changes in CMS Web Interface measures reported under the Shared Savings Program. Rather, we referred readers to Tables A, C, and D of Appendix 1: Proposed MIPS Quality Measures in the proposed rule for a complete discussion of the proposed changes to the CMS Web Interface measures. Based on the changes being finalized in Tables A, C and D of Appendix 1: Finalized MIPS Quality Measures of this final rule, ACOs will no longer be responsible for reporting the following measures for purposes of the Shared Savings Program starting with reporting for performance years during 2019:
• ACO-12 (NQF #0097) Medication Reconciliation Post-Discharge.
• ACO-15 (NQF #0043) Pneumonia Vaccination Status for Older Adults.
• ACO-16 (NQF #0421) Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow Up.
• ACO-41 (NQF #0055) Diabetes: Eye Exam.
• ACO-30 (NQF #0068) Ischemic Vascular Disease (IVD): Use of Aspirin or another Antithrombotic.
We note that ACO-41 is one measure within a two-component diabetes composite that is currently scored as one measure. The removal of ACO-41 means that ACO-27 Diabetes Hemoglobin A1c (HbA1c) Poor Control (>9%)) will now be assessed as an individual measure. As discussed in section III.I.2.B.i of this final rule, lists of the measures being finalized for purposes of MIPS are in Tables A, C and D of Appendix 1: Finalized MIPS Quality Measures.
Additionally, we proposed to add the following measure to the CMS Web Interface for purposes of the Quality Payment Program:
• ACO-47 (NQF #0101) Falls: Screening, Risk-Assessment, and Plan of Care to Prevent Future Falls.
Based on the policies being finalized for purposes of MIPS in Table A of Appendix 1: Finalized MIPS Quality Measures, Shared Savings Program ACOs will not be responsible for reporting this measure starting with quality reporting for performance years during 2019.
Table 26 shows the Shared Savings Program quality measure set for performance years during 2019 and subsequent performance years.
In this section of this final rule, we are finalizing proposals to eliminate 9 measures and to add 2 measures to the Shared Savings Program quality measure set. Separately, in August 2018 proposed rule, we also proposed to remove ACO-11—
• Patient/Caregiver Experience of Care—10 measures.
• Care Coordination/Patient Safety—4 measures.
• Preventive Health—6 measures.
• At Risk Populations—3 measures.
Table 27 provides a summary of the number of measures by domain and the total points and domain weights that will be used for scoring purposes under the changes to the quality measure set finalized in this rule.
Section 1877 of the Act, also known as the physician self-referral law: (1) Prohibits a physician from making referrals for certain designated health services (DHS) payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship (ownership or compensation), unless an exception applies; and (2) prohibits the entity from filing claims with Medicare (or billing another individual, entity, or third party payer) for those referred services. The statute establishes a number of specific exceptions, and grants the Secretary the authority to create regulatory exceptions for financial relationships that pose no risk of program or patient abuse. Additionally, the statute mandates refunding any amount collected under a bill for an item or service furnished under a prohibited referral. Finally, the statute imposes reporting requirements and provides for sanctions, including civil monetary penalty provisions.
Section 50404 of the Bipartisan Budget Act of 2018 (Pub. L. 115-123, enacted February 9, 2018) added provisions to section 1877(h)(1) of the Act pertaining to the writing and
In the CY 2016 PFS final rule with comment period (80 FR 70885), we revised § 411.357(a)(7), (b)(6), and (d)(1)(vii) to permit a lease arrangement or personal service arrangement to continue indefinitely beyond the stated expiration of the written documentation describing the arrangement under certain circumstances. Section 50404 of the Bipartisan Budget Act of 2018 added substantively identical holdover provisions to section 1877(e) of the Act. Because the new statutory holdover provisions effectively mirror the existing regulatory provisions, we do not believe it is necessary to revise § 411.357(a)(7), (b)(6), and (d)(1)(vii) as a result of these statutory revisions. Therefore, we made no proposals to these provisions.
Many of the exceptions for compensation arrangements in § 411.357 require that the arrangements are set out in writing and signed by the parties. (See § 411.357(a)(1), (b)(1), (d)(1)(i), (e)(1)(i), (e)(4)(i), (l)(1), (p)(2), (q) (incorporating the requirement contained in § 1001.952(f)(4)), (r)(2)(ii), (t)(1)(ii) or (t)(2)(iii) (both incorporating the requirements contained in § 411.357(e)(1)(i)), (v)(7), (w)(7), (x)(1)(i), and (y)(1).)
In the CY 2016 PFS final rule with comment period, we stated CMS' longstanding policy that the writing requirement in various compensation arrangement exceptions in § 411.357 can be satisfied by “a collection of documents, including contemporaneous documents evidencing the course of conduct between the parties” (80 FR 71315). Our guidance on the writing requirement appeared in the preamble of the CY 2016 PFS final rule with comment period but was not codified in regulations. Section 50404 of the Bipartisan Budget Act of 2018 added subparagraph D, “Written Requirement Clarified,” to section 1877(h)(1) of the Act. Section 1877(h)(1)(D) of the Act provides that, in the case of any requirement in section 1877 of the Act for a compensation arrangement to be in writing, such requirement shall be satisfied by such means as determined by the Secretary, including by a collection of documents, including contemporaneous documents evidencing the course of conduct between the parties involved.
In light of the recently added statutory provision at section 1877(h)(1)(D) of the Act, we proposed to add a special rule on compensation arrangements at § 411.354(e). Proposed § 411.354(e) provides that, in the case of any requirement in 42 CFR part 411, subpart J, for a compensation arrangement to be in writing, the writing requirement may be satisfied by a collection of documents, including contemporaneous documents evidencing the course of conduct between the parties. The proposed special rule at § 411.354(e) codifies our existing policy on the writing requirement, as previously articulated in the CY 2016 PFS final rule with comment period. (See 80 FR 71314
Many of the exceptions for compensation arrangements in § 411.357 require that the arrangement (that is, the written documentation evidencing the arrangement) is signed by the parties to the arrangement. Under our existing special rule for certain arrangements involving temporary noncompliance with signature requirements at § 411.353(g)(1), an entity that has a compensation arrangement with a physician that satisfies all the requirements of an applicable exception in § 411.355, § 411.356 or § 411.357 except the signature requirement may submit a claim and receive payment for a designated health service referred by the physician, provided that: (1) The parties obtain the required signature(s) within 90 consecutive calendar days immediately following the date on which the compensation arrangement became noncompliant (without regard to whether any referrals occur or compensation is paid during such 90-day period); and (2) the compensation arrangement otherwise complies with all criteria of the applicable exception. Existing § 411.353(g)(1) specifies the paragraphs where the applicable signature requirements are found and existing § 411.353(g)(2) limits an entity's use of the special rule at § 411.353(g)(1) to only once every 3 years with respect to the same referring physician.
Section 50404 of the Bipartisan Budget Act of 2018 added subparagraph E, “Signature Requirement,” to section 1877(h)(1) of the Act. Section 1877(h)(1)(E) of the Act provides that, in the case of any requirement in section 1877 of the Act for a compensation arrangement to be in writing and signed by the parties, the signature requirement is satisfied if: (1) Not later than 90 consecutive calendar days immediately following the date on which the compensation arrangement became noncompliant, the parties obtain the required signatures; and (2) the compensation arrangement otherwise complies with all criteria of the applicable exception. Notably, under the newly added section 1877(h)(1)(E) of the Act, an applicable signature requirement is not limited to specific exceptions and entities are not limited in their use of the rule to only once every 3 years with respect to the same referring physician. In addition, section 1877(h)(1)(E) of the Act does not include a reference to the occurrence of referrals or the payment of compensation during the 90-day period when the signature requirement is not met.
To conform the regulations with the recently added statutory provision at section 1877(h)(1)(E) of the Act, we proposed to amend existing § 411.353(g) by: (1) Revising the reference at § 411.353(g)(1) to specific exceptions and signature requirements; (2) deleting the reference at § 411.353(g)(1) to the
The following is a summary of the comments we received regarding the best approach for codifying in regulation sections 1877(h)(1)(D) & (E) of the Act.
Finally, we note that the effective date of section 50404 of the Bipartisan Budget Act was February 9, 2018. Thus, beginning February 9, 2018, parties who meet the requirements of section 1877(h)(1)(E) of the Act, including parties who otherwise would have been barred from relying on the special rule for certain arrangements involving temporary noncompliance with signature requirements at § 411.353(g)(1) because of the 3-year limitation at § 411.353(g)(2), may avail themselves of the new statutory provision at section 1877(h)(1)(E) of the Act.
After reviewing the comments, we are finalizing the special rule on compensation arrangements at § 411.354(e) as proposed, and we are finalizing the modifications to § 411.353(g) as proposed.
Section 1877 of the Act prohibits a physician from referring a Medicare beneficiary for certain designated health services (DHS) to an entity with which the physician (or a member of the physician's immediate family) has a financial relationship, unless an exception applies. Section 1877 of the Act also prohibits the DHS entity from submitting claims to Medicare or billing the beneficiary or any other entity for Medicare DHS that are furnished as a result of a prohibited referral.
Section 1877(h)(6) of the Act and § 411.351 of our regulations specify that the following services are DHS:
• Clinical laboratory services.
• Physical therapy services.
• Occupational therapy services.
• Outpatient speech-language pathology services.
• Radiology services.
• Radiation therapy services and supplies.
• Durable medical equipment and supplies.
• Parenteral and enteral nutrients, equipment, and supplies.
• Prosthetics, orthotics, and prosthetic devices and supplies.
• Home health services.
• Outpatient prescription drugs.
• Inpatient and outpatient hospital services.
In § 411.351, we specify that the entire scope of four DHS categories is defined in a list of CPT/HCPCS codes (the Code List), which is updated annually to account for changes in the most recent CPT and HCPCS Level II publications. The DHS categories defined and updated in this manner are:
• Clinical laboratory services.
• Physical therapy, occupational therapy, and outpatient speech-language pathology services.
• Radiology and certain other imaging services.
• Radiation therapy services and supplies.
The Code List also identifies those items and services that may qualify for either of the following two exceptions to the physician self-referral prohibition:
• EPO and other dialysis-related drugs furnished in or by an ESRD facility (§ 411.355(g)).
• Preventive screening tests, immunizations, or vaccines (§ 411.355(h)).
The definition of DHS at § 411.351 excludes services for which payment is made by Medicare as part of a composite rate (unless the services are specifically identified as DHS and are themselves payable through a composite rate, such as home health and inpatient and outpatient hospital services). Effective January 1, 2011, EPO and dialysis-related drugs furnished in or by an ESRD facility (except drugs for which there are no injectable equivalents or other forms of administration), have been reimbursed under a composite rate known as the ESRD prospective payment system (ESRD PPS) (75 FR 49030). Accordingly, EPO and any dialysis-related drugs that are paid for under ESRD PPS are not DHS and are not listed among the drugs that could qualify for the exception at § 411.355(g) for EPO and other dialysis-related drugs furnished by an ESRD facility.
ESRD-related oral-only drugs, which are drugs or biologicals with no injectable equivalents or other forms of administration other than an oral form, were scheduled to be paid under ESRD PPS beginning January 1, 2014 (75 FR 49044). However, there have been several delays of the implementation of payment of these drugs under ESRD PPS. On December 19, 2014, section 204 of the Stephen Beck, Jr., Achieving a Better Life Experience Act of 2014
The Code List was last updated in Tables 44 and 45 of the CY 2018 PFS final rule (82 FR 53339).
We received no comments relating to the Code List that became effective January 1, 2018.
The updated, comprehensive Code List effective January 1, 2019, is available on our website at
Additions and deletions to the Code List conform it to the most recent publications of CPT and HCPCS Level II and to changes in Medicare coverage policy and payment status.
Tables 28 and 29 identify the additions and deletions, respectively, to the comprehensive Code List that become effective January 1, 2019. Tables 28 and 29 also identify the additions and deletions to the list of codes used to identify the items and services that may qualify for the exception in § 411.355(g) (regarding dialysis-related outpatient prescription drugs furnished in or by an ESRD facility) and in § 411.355(h) (regarding preventive screening tests, immunizations, and vaccines).
This final rule will make payment and policy changes to the Quality Payment Program starting January 1, 2019, except as noted for specific provisions elsewhere in this final rule. The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, enacted April 16, 2015) amended title XVIII of the Act to repeal the Medicare sustainable growth rate (SGR) formula, to reauthorize the Children's Health Insurance Program, 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 participate in the Quality Payment Program, which rewards value in one of two ways:
• The Merit-based Incentive Payment System (MIPS).
• Advanced Alternative Payment Models (Advanced APMs).
As we move into the third year of the Quality Payment Program, we have taken all stakeholder input into consideration, including recommendations made by the Medicare Payment Advisory Commission (MedPAC), an independent congressional agency established by the Balanced Budget Act of 1997 (Pub. L. 105-33, enacted on August 5, 1997) to advise the U.S. Congress on issues
Additionally, we have also received feedback from stakeholders regarding the added value of the Quality Payment Program. To that point, CMS has begun a series of strategic planning sessions to (1) assess the current value of the program for clinicians and beneficiaries alike and (2) implement the program in a way that is understandable to beneficiaries, as they are the core of the Medicare program.
As a priority for the Quality Payment Program Year 3, we are committed to continue using the framework established by the Patients over Paperwork initiative to assist in reducing clinician burden, implementing the Meaningful Measures Initiative, promoting interoperability, continuing our support of small and rural practices, empowering patients, and promoting price transparency.
We are committed to reducing clinician burden by simplifying and streamlining the program for participating clinicians. Examples include:
• Implementing the Meaningful Measures Initiative, which is a framework that applies a series of cross-cutting criteria to identify and utilize the most meaningful measures with the least amount of burden and greatest impact on patient outcomes;
• Promoting advances in interoperability; and
• Establishing an automatic extreme and uncontrollable circumstances policy for MIPS eligible clinicians.
Regulatory reform and reducing regulatory burden are high priorities for CMS. To reduce the regulatory burden on the healthcare industry, lower health care costs, and enhance patient care, we launched the Meaningful Measures Initiative in October 2017.
The Meaningful Measures Framework has the following principles for identifying measures that:
• Address high-impact measure areas that safeguard public health;
• Patient-centered and meaningful to patients;
• Outcome-based where possible;
• Fulfill each program's statutory requirements;
• Minimize the level of burden for health care providers (for example, through a preference for EHR-based measures where possible, such as electronic clinical quality measures);
• Significant opportunity for improvement;
• Address measure needs for population based payment through alternative payment models; and
• Align across programs and/or with other payers.
To achieve these objectives, we have identified 19 Meaningful Measures areas and mapped them to six overarching quality priorities as shown in Table 30.
By including Meaningful Measures in our programs, we believe that we can also address the following cross-cutting measure criteria:
• Eliminating disparities;
• Tracking measurable outcomes and impact;
• Safeguarding public health;
• Achieving cost savings;
• Improving access for rural communities; and
• Reducing burden.
We believe that the Meaningful Measures Initiative will improve outcomes for patients, their families, and health care providers while reducing burden and costs for clinicians and providers and promoting operational efficiencies.
In the quality performance category under MIPS, clinicians have the flexibility to select and report the measures that matter most to their practice and patients. However, we have received feedback that some clinicians find the performance requirements confusing, and the program makes it difficult for them to choose measures that are meaningful to their practices and have more direct benefit to beneficiaries. For the 2019 MIPS performance period, we are finalizing the following updates: (1) Adding 8 new MIPS quality measures that include 4 patient reported outcome measures, 6 high priority measures, and 2 measures on important clinical topics in the Meaningful Measures framework; and (2) removing 26 quality measures.
In addition to having the right measures, we want to ensure that the collection of information is valuable to clinicians and worth the cost and resources of collecting the information.
As required by MACRA, the Quality Payment Program includes a MIPS performance category that focuses on meaningful use of certified EHR technology, referred to in the CY 2017 and CY 2018 Quality Payment Program final rules as the “advancing care information” performance category. As part of our approach to promoting and prioritizing interoperability of healthcare data, in Quality Payment Program Year 2, we changed the name of the performance category to the Promoting Interoperability performance category.
We have prioritized interoperability, which we define as health information technology, that enables the secure exchange of electronic health information with, and use of electronic health information from, other health information technology without special effort on the part of the user; allows for complete access, exchange, and use of all electronically accessible health information for authorized use under applicable law; and does not constitute information blocking as defined by the 21st Century Cures Act (Pub. L. 114-255, enacted December 13, 2016). We are committed to working with the Office of the National Coordinator for Health IT (ONC) on implementation of the interoperability provisions of the 21st Century Cures Act to have seamless but secure exchange of health information for clinicians and patients, ultimately enabling Medicare beneficiaries to get their claims information electronically. In addition, we are prioritizing quality measures and improvement activities that support interoperability.
To further CMS' commitment to implementing interoperability, at the 2018 Healthcare Information and Management Systems Society (HIMSS) conference, CMS Administrator Seema Verma announced the launching of the MyHealthEData initiative.
For the Promoting Interoperability performance category, we require MIPS eligible clinicians to use 2015 Edition certified EHR technology beginning with the 2019 MIPS performance period to make it easier for:
• Patients to access their data.
• Patient information to be shared between doctors and other health care providers.
We understand that the Quality Payment Program is a big change for clinicians, especially for those in small and rural practices. We intend to continue to offer tailored flexibilities to help these clinicians to participate in the program. For example, in this rule we are finalizing our proposal to retain a small practice bonus under MIPS by moving it to the quality performance category. We will also continue to support small and rural practices by offering free and customized resources available within local communities, including direct, one-on-one support from the Small, Underserved, and Rural Support Initiative along with our other no-cost technical assistance.
Further, we note that we are finalizing our proposal to amend our regulatory text to allow small practices to continue using the Medicare Part B claims collection type. We are also finalizing our proposal to revise the regulatory text to allow a small practice to submit quality data for covered professional services through the Medicare Part B claims submission type for the quality performance category, as discussed further in section III.I.3.h. of this final rule. Finally, in the CY 2018 Quality Payment Program final rule, we finalized a policy to allow small practices to continue to choose to participate in MIPS as a virtual group (82 FR 53598).
Our Patients Over Paperwork initiative establishes an internal process to evaluate and streamline regulations with a goal to reduce unnecessary burden, to increase efficiencies, and to
The policies for the Quality Payment Program in this final rule promote competition and empower patients. We are consistently listening, and we are committed to using data-driven insights, increasingly aligned and meaningful quality measures, and technology that empowers patients and clinicians to make decisions about their healthcare.
In conjunction with development of the Patients Over Paperwork initiative, we are making progress toward developing a patient-centered portfolio of measures for the Quality Payment Program, including 7 new outcome measures included on the 2017 CMS Measures Under Consideration List,
In May 2018, CMS announced that 91 percent of MIPS eligible clinicians participated in the 2017 transition year. (See
During the first 2 years of the program, we have heard concerns from clinicians that were not eligible to participate. Under MIPS, for year 3, we are expanding in this final rule the opportunities to participate, while still understanding the burden required to participate, to include physical therapists, occupational therapists, qualified speech-language pathologists, qualified audiologists, clinical psychologists, and registered dietitians or nutrition professionals in the list of MIPS eligible clinicians. We also are finalizing an opt-in policy that allows some clinicians, who otherwise would have been excluded under the low-volume threshold, the option to participate in MIPS.
We believe the third year of the Quality Payment Program should build upon the foundation that has been established in the first 2 years, which provides a trajectory for clinicians moving to a performance-based payment system. This trajectory provides clinicians the ability to participate in the program through two pathways: MIPS and Advanced APMs.
As discussed in section VII.F.8. of this final rule, for the 2021 payment year and based on Advanced APM participation during the 2019 MIPS performance period, we estimate that between 165,000 and 220,000 clinicians will become Qualifying APM Participants (QP). As a QP, an eligible clinician is not subject to the MIPS reporting requirements and payment adjustment, and qualifies for a lump sum APM incentive payment equal to 5 percent of their aggregate payment amounts for covered professional services for the year prior to the payment year. We estimate that the total lump sum APM incentive payments will be approximately $600-800 million for the 2021 Quality Payment Program payment year.
Again, we estimate that approximately 798,000 clinicians would be MIPS eligible clinicians in the 2019 MIPS performance period, an increase of almost 148,000 from the estimate we provided in the CY 2019 PFS proposed rule, which reflects growth in group reporting and our ability to better capture group reporting. The final number will depend on several factors, including the number of eligible clinicians excluded from MIPS based on their status as QPs or Partial QPs, the number that report as groups, and the number that elect to opt-in to MIPS. In the 2021 MIPS payment year, MIPS payment adjustments, which only apply to covered professional services, will be applied based on MIPS eligible clinicians' performance on specified measures and activities within four integrated performance categories. We estimate that MIPS payment adjustments will be approximately equally distributed between negative MIPS payment adjustments ($390 million) and positive MIPS payment adjustments ($390 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 75 points that we are establishing in this final rule. However, the distribution will change based on the final population of MIPS eligible clinicians for the 2021 MIPS payment year and the distribution of final scores under the program.
At § 414.1305, subpart O—
• We are revising in this final rule the regulation to define the following terms:
++ Ambulatory Surgical Center (ASC)-based MIPS eligible clinician.
++ Collection type.
++ Health IT vendor.
++ MIPS determination period.
++ Submission type.
++ Submitter type.
++ Third party intermediary.
• We are revising in this final rule the definitions of the following terms:
++ High priority measure.
++ Hospital-based MIPS eligible clinician
++ Low-volume threshold.
++ MIPS eligible clinician.
++ Non-patient facing MIPS eligible clinician.
++ Qualified clinical data registry (QCDR).
++ Qualifying APM Participant (QP).
++ Small practice.
Under § 414.1305, a MIPS eligible clinician, as identified by a unique billing TIN and NPI combination used to assess performance, is defined 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. Section 1848(q)(1)(C)(II) of the Act provides the Secretary with discretion, beginning with the 2021 MIPS payment year, to specify additional eligible clinicians (as defined in section 1848(k)(3)(B) of the Act) as MIPS eligible clinicians. Such clinicians may include physical therapists, occupational therapists, or qualified speech-language pathologists; qualified audiologists (as defined in section 1861(ll)(3)(B) of the Act); certified nurse-midwives (as defined in section 1861(gg)(2) of the Act); clinical social workers (as defined in section 1861(hh)(1) of the Act); clinical psychologists (as defined by the Secretary for purposes of section 1861(ii) of the Act); and registered dietitians or nutrition professionals.
As discussed in the CY 2019 PFS proposed rule (83 FR 35883 through 35884), we received feedback from non-physician associations representing each type of additional eligible clinician through listening sessions and meetings with various stakeholder entities and through public comments discussed in the CY 2017 Quality Payment Program final rule (81 FR 77038). Commenters generally supported the specification of such clinicians as MIPS eligible clinicians beginning with the 2021 MIPS payment year. In order to assess whether these additional eligible clinicians could successfully participate in MIPS, we evaluated whether there would be sufficient measures and activities applicable and available for each of the additional eligible clinician types. We finalized in the CY 2018 Quality Payment Program final rule (82 FR 53780), that having sufficient measures for the quality performance category, means 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 clinician. For the improvement activities performance category, we stated the belief that all MIPS eligible clinicians will have sufficient activities applicable and available. We focused our analysis on the quality and improvement activities performance categories because these performance categories require submission of data. We did not focus on the Promoting Interoperability performance category because there is extensive analysis regarding who can participate in the Promoting Interoperability performance category under the current exclusion criteria. In addition, in section III.I.3.h.(5) of this final rule, we are finalizing a policy to automatically assign a zero percent weighting for the Promoting Interoperability performance category for these new types of MIPS eligible clinicians. We did not focus as part of our analysis on the cost performance category because we are only able to assess cost performance for a subset of eligible clinicians—specifically, those who are currently eligible as a result of not meeting any of the current exclusion criteria. So the impact of the cost performance category for these additional eligible clinicians will continue to be considered but is currently not a decisive factor for successful participation in MIPS. From our analysis, we found that improvement activities would generally be applicable and available for each of the additional eligible clinician types. However, for the quality performance category, we found that not all of the additional eligible clinician types would have sufficient MIPS quality measures applicable and available. As discussed in section III.I.3.h.(2)(b)(iii) of this final rule, for the quality performance category, we are finalizing our proposals to remove several MIPS quality measures. In the CY 2019 PFS proposed rule (83 FR 35883 through 35884), we explained that if those measures were finalized for removal, we anticipated that qualified speech-language pathologists, qualified audiologists, certified nurse-midwives, and registered dietitians or nutrition professionals would each have less than 6 MIPS quality measures applicable and available to them. However, if the quality measures were not finalized for removal, we would reassess whether these eligible clinicians would have an adequate amount of MIPS quality measures available to them. We proposed to include these additional clinicians in the MIPS eligible clinician definition if we found that they do have at least 6 MIPS quality measures available to them. As discussed in “Appendix 1: Finalized MIPS Quality Measures”, TABLE Group C. of this final rule, we are retaining one of the MIPS quality measures that was proposed for removal: “Colonoscopy Interval for Patients with a History of Adenomatous Polyps—Avoidance of Inappropriate Use” (Quality #185). We do not believe that this measure is applicable to any of the proposed additional eligible clinicians. Therefore, it does not affect the number of available measures for these clinicians. We refer readers to section III.I.3.h.(2) of this final rule for more information regarding quality measures.
We focused on the quality performance category because the quality and improvement activities performance categories require submission of data. We believed there would generally be applicable and available improvement activities for each of the additional eligible clinician types, but that not all of the additional eligible clinician types would have sufficient MIPS quality measures applicable and available if the proposed MIPS quality measures were removed from the program. In our analysis, we did find QCDR measures approved for the CY 2018 performance period that are either high priority and/or outcome measures that, if approved for the CY 2019 performance period, may be applicable to these additional eligible clinicians. However, this would necessitate that the clinician utilize a QCDR in order to be successful in MIPS. Further, we have heard some concerns from the non-physician associations, through written correspondence, that since their clinicians would be joining the program 2 years after its inception, we should consider several ramp-up policies in order to facilitate an efficient integration of these clinicians into MIPS. We note that the MIPS program is still ramping up, and we will continue to increase the performance threshold to ensure a gradual and incremental transition to the performance threshold that will be used in the Quality Payment Program Year 6. Therefore, if specified as MIPS eligible clinicians beginning with the 2021 MIPS payment year, the additional eligible clinicians would have 4 years in the program in order to ramp up. Conversely, if specified as MIPS eligible clinicians beginning in a future year, they would be afforded less time to ramp up the closer the program gets to Quality Payment Program Year 6.
We requested comments on our proposal to amend § 414.1305 to modify the definition of a MIPS eligible clinician, as identified by a unique billing TIN and NPI combination used to assess performance, to mean any of
The following is a summary of the public comments received on our proposals and our responses:
After consideration of the public comments received, we are finalizing a modification of our proposal to amend § 414.1305 to revise the definition of a MIPS eligible clinician, as identified by a unique billing TIN and NPI combination used to assess performance, to mean 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); beginning with the 2021 MIPS payment year, a physical therapist, occupational therapist, qualified speech-language pathologist; qualified audiologist (as defined in section 1861(ll)(3)(B) of the Act); clinical psychologist (as defined by the Secretary for purposes of section 1861(ii) of the Act); and registered dietician or nutrition professional; and a group that includes such clinicians.
As discussed in the proposed rule (83 FR 35884 through 35886), currently MIPS uses various determination periods to identify certain MIPS eligible clinicians for consideration for certain applicable policies. For example, the low-volume threshold, non-patient facing, small practice, hospital-based, and ambulatory surgical center (ASC)-based determinations are on the same timeline with slight differences in the claims run-out policies, whereas the facility-based determinations has a slightly different determination period. The virtual group eligibility determination requires a separate election process. We proposed to add a virtual group eligibility determination period beginning in CY 2020 as discussed in section III.I.3.f.(2)(a) of this final rule. In addition, the rural and HPSA determinations do not utilize a determination period.
Under § 414.1305, the low-volume threshold determination period is described as a 24-month assessment period consisting of 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 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 2020 MIPS payment year and future years, each segment of the low-volume threshold determination period includes a 30-day claims run out.
Under § 414.1305, the non-patient facing determination period is described as a 24-month assessment period consisting of 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 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 2020 MIPS payment year and future years, each segment of the non-patient facing determination period includes a 30-day claims run out.
In the CY 2018 Quality Payment Program final rule (82 FR 53581), we finalized that for the small practice size determination period, we would utilize 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.
In the CY 2017 Quality Payment Program final rule (81 FR 77238 through 77240), we finalized that to identify a MIPS eligible clinician as hospital-based we would 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.
In the CY 2018 Quality Payment Program final rule (82 FR 53684 through 53685), we finalized that to identify a MIPS eligible clinician as ASC-based, we would 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.
In the CY 2018 Quality Payment Program final rule (82 FR 53760), we discussed, but did not finalize, our proposal or the alternative option for how an individual clinician or group would elect to use and be identified as using facility-based measurement for the MIPS program. Because we were not offering facility-based measurement until the 2019 MIPS performance period, we did not need to finalize either of these for the 2018 MIPS performance period. However, as discussed in section III.I.3.i.(1)(d) of this final rule, we proposed to amend § 414.1380(e)(2)(i)(A) to specify a criterion for a clinician to be eligible for facility-based measurement. Specifically, that is, the clinician furnishes 75 percent or more of his or her covered professional services in sites of service identified by the place of service codes used in the HIPAA standard transaction as an inpatient hospital, on-campus outpatient hospital, or emergency room setting based on claims for a 12-month segment beginning on October 1 of the calendar year 2 years prior to the applicable performance period and ending on September 30 of the calendar year preceding the applicable performance period with a 30-days claims run out. We did not propose to utilize the MIPS determination period for purposes of the facility-based determination because for the facility-based determination, we are only using the first segment of the MIPS determination period. We are using the
In the CY 2018 Quality Payment Program final rule (82 FR 53602 through 53604), we finalized that for the virtual group eligibility determination period, we would utilize 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 include a 30-day claims run out. To capture a real-time representation of TIN size, we finalized that we would 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. 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. Beginning with the 2019 performance period, we proposed to amend § 414.1315(c)(1) to establish a virtual group eligibility determination period to align with the first segment of the MIPS determination period, which includes an analysis of claims data during a 12-month assessment period (fiscal year) that would begin on October 1 of the calendar year 2 years prior to the applicable performance period and end on September 30 of the calendar year preceding the applicable performance period and include a 30-day claims run out. We refer readers to section III.I.3.f.(2)(a) of this final rule for further details on this proposal.
In addition, we have established other special status determinations, including rural area and HPSA. Rural area is defined at § 414.1305 as a ZIP code designated as rural, using the most recent Health Resources and Services Administration (HRSA) Area Health Resource File data set available. HPSAs are defined at § 414.1305 as areas designated under section 332(a)(1)(A) of the Public Health Service Act.
We understand that the current use of various MIPS determination periods is complex and causes confusion. Therefore, beginning with the 2021 MIPS payment year, we proposed to consolidate several of these policies into a single MIPS determination period that would be used for purposes of the low-volume threshold and to identify MIPS eligible clinicians as non-patient facing, a small practice, hospital-based, and ASC-based, as applicable. We did not propose to include the facility-based or virtual group eligibility determination periods or the rural and HPSA determinations in the MIPS determination period, as they each require a different process or timeline that does not align with the other determination periods, or do not utilize determination periods. We invited public comments on the possibility of incorporating these determinations into the MIPS determination period in the future.
There are several reasons we believe a single MIPS determination period for most of the eligibility criteria is the most appropriate. First, it would simplify the program by aligning most of the MIPS eligibility determination periods. Second, it would continue to allow us to provide eligibility determinations as close to the beginning of the performance period as feasible. Third, we believe a timeframe that aligns with the fiscal year is easier to communicate and more straightforward to understand compared to the current determination periods. Finally, it would allow us to extend our data analysis an additional 30 days.
It is important to note that during the final 3 months of the calendar year in which the performance period occurs, in general, we do not believe it would be feasible for many MIPS eligible clinicians who join an existing practice (existing TIN) or join a newly formed practice (new TIN) to participate in MIPS as individuals. We refer readers to section III.I.3.i.(2)(b) of this final rule for more information on the proposed reweighting policies for MIPS eligible clinicians who join an existing practice or who join a newly formed practice during this timeframe.
We requested comments on our proposal that beginning with the 2021 MIPS payment year, the MIPS determination period would be a 24-month assessment period including a two-segment analysis of claims data consisting of: (1) An initial 12-month segment beginning on October 1 of the calendar year 2 years prior to the applicable performance period and ending on September 30 of the calendar year preceding the applicable performance period; and (2) a second 12-month segment beginning on October 1 of the calendar year preceding the applicable performance period and ending on September 30 of the calendar year in which the applicable performance period occurs. The first segment would include a 30-day claims run out. The second segment would not include a claims run out, but would include quarterly snapshots for informational use only, if technically feasible. For example, a clinician could use the quarterly snapshots to understand their eligibility status between segments. Specifically, we believe the quarterly snapshots would be helpful for new TIN/NPIs and TINs created between the first segment and the second segment allowing them to see their preliminary eligibility status sooner. Without the quarterly snapshots, these clinicians would not have any indication of their eligibility status until just before the submission period. An individual eligible clinician or group that is identified as not exceeding the low-volume threshold, or a MIPS eligible clinician that is identified as non-patient facing, a small practice, hospital-based, or ASC-based, as applicable, during the first segment would continue to be identified as such for the applicable MIPS payment year regardless of the second segment. For example, for the 2021 MIPS payment year, the first segment would be October 1, 2017 through September 30, 2018, and the second segment would be October 1, 2018 through September 30, 2019. However, based on our experience with the Quality Payment Program, we believe that some eligible clinicians, whose TIN or TIN/NPIs are identified as eligible during the first segment and do not exist in the second segment, are no longer utilizing these same TIN or TIN/NPI combinations. Therefore, because those TIN or TIN/NPIs would not exceed the low-volume threshold in the second segment, they would no longer be eligible for MIPS. For example, in the 2019 performance period a clinician exceeded the low-volume threshold during the first segment of the determination period (data from the end of CY 2017 to early 2018) under one TIN; then in CY 2019 the clinician switches practices under a new TIN and during segment two of the determination period. Therefore, it is determined that the clinician is not eligible (based on CY 2019 data) under either TIN. This clinician would not be eligible to participate in MIPS based on either segment of the determination
The following is a summary of the public comments received on our proposals and our responses:
After consideration of the public comments received, we are finalizing our proposal to define MIPS determination period at § 414.1305 beginning with the 2021 MIPS payment year, as a 24-month assessment period including a two-segment analysis of claims data consisting of: (1) An initial 12-month segment beginning on October 1 of the calendar year 2 years prior to the applicable performance period and ending on September 30 of the calendar year preceding the applicable performance period; and (2) a second 12-month segment beginning on October 1 of the calendar year preceding the applicable performance period and ending on September 30 of the calendar year in which the applicable performance period occurs. The first segment would include a 30-day claims run out. The second segment would not include a claims run out, but would include quarterly snapshots for informational use only, if technically feasible. In addition, we are finalizing that subject to § 414.1310(b)(1)(iii), an individual eligible clinician or group that is identified as not exceeding the low-volume threshold or as having special status during the first segment of the MIPS determination period will continue to be identified as such for the applicable MIPS payment year regardless of the results of the second segment of the MIPS determination period. An individual eligible clinician or group for which the unique billing TIN and NPI combination is established during the second segment of the MIPS determination period will be assessed based solely on the results of that segment. Finally, at § 414.1305 we are finalizing our proposal to modify the definitions of low-volume threshold, non-patient facing MIPS eligible clinician, a small practice, hospital-based MIPS eligible clinician, and ASC-based MIPS eligible clinician at § 414.1305 to incorporate references to the MIPS determination period.
As discussed in the CY 2019 PFS proposed rule (83 FR 35886), section 1848(q)(1)(C)(iv) of the Act, as amended by section 51003(a)(1)(A)(ii) of the Bipartisan Budget Act of 2018, provides that, for performance periods beginning on or after January 1, 2018, the low-volume threshold selected by the Secretary may include one or more or a combination of the following (as determined by the Secretary): (1) The minimum number of part B-enrolled individuals who are furnished covered professional services (as defined in section 1848(k)(3)(A) of the Act) by the eligible clinician for the performance period involved; (2) the minimum number of covered professional services furnished to part B-enrolled individuals by such clinician for such performance period; and (3) the minimum amount of allowed charges for covered professional services billed by such clinician for such performance period.
Under § 414.1310(b)(1)(iii), for a year, eligible clinicians who do not exceed the low-volume threshold for the performance period with respect to a year are excluded from MIPS. Under § 414.1305, the low-volume threshold is defined as, 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, 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. In addition, for the 2020 MIPS payment year and future years, the low-volume threshold is defined as the low-volume threshold that applies to an individual 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. The low-volume threshold determination period is a 24-month assessment period consisting of: (1) 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 (2) 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, each segment of the low-volume threshold determination period includes a 30-day claims run out.
In the CY 2019 PFS proposed rule (83 FR 35887), we proposed to amend § 414.1305 to modify the definition of low-volume threshold in accordance with section 1848(q)(1)(C)(iv) of the Act, as amended by section 51003(a)(1)(A)(ii) of the Bipartisan Budget Act of 2018. Specifically, we requested comments on our proposals that for the 2020 MIPS payment year, we will utilize the minimum number (200 patients) of Part B-enrolled individuals who are furnished covered professional services by the eligible clinician or group during the low-volume threshold determination period or the minimum amount ($90,000) of allowed charges for covered professional services to Part B-enrolled individuals by the eligible clinician or group during the low-volume threshold determination period.
The following is a summary of the public comments received on our proposals and our responses:
After consideration of the public comments received, we are finalizing our proposal to amend § 414.1305 to modify the definition of low-volume threshold to mean for the 2020 MIPS payment year, we will utilize the minimum number (200 patients) of Part B-enrolled individuals who are furnished covered professional services by the eligible clinician or group during the low-volume threshold determination period or the minimum amount ($90,000) of allowed charges for covered professional services to Part B-enrolled individuals by the eligible clinician or group during the low-volume threshold determination period.
In the CY 2019 PFS proposed rule (83 FR 35887), we requested comments on our proposal to modify § 414.1310 to specify in paragraph (a), Program Implementation, that except as specified in paragraph (b), MIPS applies to payments for covered professional services furnished by MIPS eligible clinicians on or after January 1, 2019. We also requested comments on our proposal to revise § 414.1310(b)(1)(ii) to specify that for a year, a MIPS eligible clinician does not include an eligible clinician that is a Partial Qualifying APM Participant (as defined in § 414.1305) and does not elect, as discussed in section III.I.4.e. of this final rule, to report on applicable measures and activities under MIPS. Finally, we requested comments on our proposal to revise § 414.1310(d) to specify that, in no case will a MIPS payment adjustment factor (or additional MIPS payment adjustment factor) apply to payments for covered professional services furnished during a year by eligible clinicians (including those described in paragraphs (b) and (c) of this section) who are not MIPS eligible clinicians, including those who voluntarily report on applicable measures and activities under MIPS.
We did not receive any comments regarding these proposals.
We are finalizing our proposal to modify § 414.1310 to specify in paragraph (a), Program Implementation, that except as specified in paragraph (b), MIPS applies to payments for covered professional services furnished by MIPS eligible clinicians on or after January 1, 2019. We are also finalizing our proposal to revise § 414.1310(b)(1)(ii) to specify that for a year, a MIPS eligible clinician does not include an eligible clinician that is a Partial Qualifying APM Participant (as defined in § 414.1305) and does not elect, as discussed in section III.I.4.e. of this final rule, to report on applicable measures and activities under MIPS. Finally, we are finalizing our proposal to revise § 414.1310(d) to specify that, in no case will a MIPS payment adjustment factor (or additional MIPS payment adjustment factor) apply to payments for covered professional services furnished during a year by eligible clinicians (including those described in paragraphs (b) and (c) of this section) who are not MIPS eligible clinicians, including those who voluntarily report on applicable measures and activities under MIPS.
In the CY 2018 Quality Payment Program final rule (82 FR 53591), we received several comments in response to the proposed rule regarding adding a third criterion of items and services for defining the low-volume threshold. We refer readers to that rule for further details.
As discussed in the CY 2019 PFS proposed rule (83 FR 35887) for the 2021 MIPS payment year and future years, we proposed to add one additional criterion to the low-volume threshold determination—the minimum number of covered professional services furnished to Part B-enrolled individuals by the clinician. Specifically, we requested comments on our proposal, for the 2021 MIPS payment year and future years, that eligible clinicians or groups who meet at least one of the following three criteria during the MIPS determination period will not exceed the low-volume threshold: (1) Those who have allowed charges for covered professional services less than or equal to $90,000; (2) those who provide covered professional services to 200 or fewer Part B-enrolled individuals; or (3) those who provide 200 or fewer covered professional services to Part B-enrolled individuals.
For the third criterion, we proposed to set the threshold at 200 or fewer covered professional services furnished to Part B-enrolled individuals for several reasons. First, in the CY 2018 Quality Payment Program final rule (82 FR 53589 through 53590), although we received positive feedback from stakeholders on the increased low-volume threshold, we also heard from some stakeholders that they would like to participate in the program. Second, setting the third criterion at 200 or fewer covered professional services, combined with our proposed policy with respect to opting in to MIPS, allows us to ensure that a significant number of eligible clinicians have the ability to opt-in if they wish to participate in MIPS. Finally, when we considered where to set the low-volume threshold for covered professional services, we examined two options: 100 or 200 covered professional services. For 100 covered professional services, there is some historical precedent. In the CY 2017 Quality Payment Program final rule (81 FR 77062), we finalized a low-volume threshold that excluded individual eligible clinicians or groups that have Medicare Part B allowed charges less than $30,000 or that provide care for 100 or fewer Part B-
The following is a summary of the public comments received on our proposals and our responses:
We understand that some MIPS eligible clinicians may work in small group practices and may not have the same resources as a large group. As discussed in the proposed rule (83 FR 35882) we intend to continue to offer tailored flexibilities to help these clinicians to participate in the program. For example, we are finalizing to retain a small practice bonus under MIPS by moving it to the quality performance category. We will also continue to
We do not believe that the total amount of dollars available for the payment adjustments is low because too many clinicians are excluded from the program. After incorporating the data submitted for the 2017 MIPS performance period (which we refer to as Quality Payment Program Year 1 data) to estimate the CY 2021 MIPS payment year, an estimated three-quarters (approximately $66.6B) of all PFS dollars will be included in the CY 2021 MIPS payment year. Of the remaining one-quarter (approximately $23.2B), only 2 percent (or less than 1 percent of total PFS dollars) were associated with clinicians who did not meet the low-volume threshold. The remaining clinicians excluded from the budget neutral payment adjustments were Qualifying APM Participants, clinicians with ineligible specialties, and newly enrolled clinicians (11 percent of total PFS dollars). We considered the impact of lowering the low-volume threshold to $30,000/100 beneficiaries/100 covered professional services from the finalized low-volume threshold of this final rule based on the budget neutrality distributions and the size of the total payments. As seen in Figure 1, reducing the low-volume threshold to $30,000/100 beneficiaries/100 covered professional services)
After consideration of the public comments received, we are finalizing our proposal to modify the definition of low-volume threshold at § 414.1305, to mean that for the 2021 MIPS payment year and future years, that eligible clinicians or groups who meet at least one of the following three criteria during the MIPS determination period will not exceed the low-volume threshold: (1) Those who have allowed charges for covered professional services less than or equal to $90,000; (2) those who provide covered professional services to 200 or fewer Part B-enrolled individuals; or (3) those who provide 200 or fewer covered professional services to Part B-enrolled individuals.
In the CY 2018 Quality Payment Program proposed rule (82 FR 30026), we proposed the option to opt-in to MIPS participation if clinicians might otherwise be excluded under the low-volume threshold. We received general support from comments received on that final rule (82 FR 53589). However, we did not finalize the proposal for the 2019 MIPS performance period at that time. We were concerned that we would not be able to operationalize this policy in a low-burden manner to MIPS eligible clinicians as it was proposed.
After consideration of operational and user experience implications of an opt-in policy, we proposed an approach we believed could be implemented in a way that provides the least burden to clinicians. As discussed in the CY 2019 PFS proposed rule (83 FR 35887 through 35890), we proposed to modify § 414.1310(b)(1)(iii) to provide that beginning with the 2021 MIPS payment year, if an eligible clinician or group meets or exceeds at least one, but not all, of the low-volume threshold determinations, including as defined by dollar amount (less than or equal to $90,000) or number of beneficiaries (200 or fewer), or number of covered professional services (200 or fewer), then such eligible individual or group may choose to opt-in to MIPS.
This policy would apply to individual eligible clinicians and groups who exceed at least one, but not all, of the low-volume threshold criteria and would otherwise be excluded from MIPS participation as a result of the low-volume threshold. We believed that it would be beneficial to provide, to the extent feasible, such individual eligible clinicians and groups with the ability to opt-in to MIPS. Conversely, this policy would not apply to individual eligible clinicians and groups who exceed all of the low-volume threshold criteria, who unless otherwise excluded, are required to participate in MIPS. In addition, this policy would not apply to individual eligible clinicians and groups who do not exceed any of the low-volume threshold criteria, who would be excluded from MIPS participation without the ability to opt-in to MIPS. Although we believe we proposed the appropriate balance for the low-volume threshold elements and the opt-in policy, we requested comments on other low-volume threshold criteria and supporting justification for the recommended criteria.
Under the proposed policies, we estimated clinician eligibility based on the following (we refer readers to the regulatory impact analysis in section VII.F.8.b. of this final rule for further details on our assumptions): (1) Eligible because they exceed all three criteria of the low-volume threshold and are not otherwise excluded (estimated 770,000 based on our assumptions of who did individual and group reporting); (2) eligible because they exceed at least one, but not all, of the low-volume threshold criteria and elect to opt-in (estimated 28,000 for a total MIPS eligible clinician population of approximately 798,000); (3) potentially eligible if they either did group reporting or elected to opt-in
We proposed that applicable eligible clinicians who meet one or two, but not all, of the criteria to opt-in and are interested in participating in MIPS would be required to make a definitive choice to either opt-in to participate in MIPS or choose to voluntarily report before data submission (83 FR 35888). If they do not want to participate in MIPS, they will not be required to do anything and will be excluded from MIPS under the low-volume threshold. For those who do want to participate in MIPS, we considered the option of allowing the submission of data to signal that the clinician is choosing to participate in MIPS. However, we anticipated that some clinicians who utilize the quality data code (QDC) claims submission type may have their systems coded to automatically append QDCs on claims for eligible patients. We were concerned that they could submit a QDC code and inadvertently opt-in when that was not their intention.
For individual eligible clinicians and groups to make an election to opt-in or voluntarily report to MIPS, they will make an election via the Quality Payment Program portal by logging into their account and simply selecting either the option to opt-in (positive, neutral, or negative MIPS adjustment) or to remain excluded and voluntarily report (no MIPS adjustment). Once the eligible clinician has elected to participate in MIPS, the decision to opt-in to MIPS will be irrevocable and cannot be changed for the applicable performance period. Clinicians who opt-in will be subject to the MIPS payment adjustment during the applicable MIPS payment year. Clinicians who do not decide to opt-in to MIPS will remain excluded and may choose to voluntarily report. Such clinicians will not receive a MIPS payment adjustment factor. To assist commenters in providing pertinent comments, we developed a website that provided design examples of the different approaches to MIPS participation in CY 2019. The website utilized wireframe (schematic) drawings to illustrate the three different approaches to MIPS participation: Voluntary reporting to MIPS, opt-in reporting to MIPS, and required to
The option to opt-in to participate in the MIPS as a result of an individual eligible clinician or group exceeding at least one, but not all, of the low-volume threshold elements differs from the option to voluntarily report to the MIPS as established at § 414.1310(b)(2) and (d). Individual eligible clinicians and groups opting-in to participate in MIPS will be considered MIPS eligible clinicians, and therefore subject to the MIPS payment adjustment factor; whereas, individual eligible clinicians and groups voluntarily reporting measures and activities for the MIPS are not considered MIPS eligible clinicians, and therefore not subject to the MIPS payment adjustment factor. MIPS eligible clinicians and groups that made an election to opt-in will be able to participate in MIPS at the individual, group, or virtual group level for that performance period. Eligible clinicians and groups that are excluded from MIPS, but voluntarily report, are able to report measures and activities at the individual or group level; however, such eligible clinicians and groups are not able to voluntarily report for MIPS at the virtual group level.
In Table 31, we provided possible scenarios regarding which eligible clinicians may be able to opt-in to MIPS depending upon their beneficiary count, dollars, and covered professional services if the proposed opt-in policy was finalized.
We recognize that the low-volume threshold opt-in option may expand MIPS participation at the individual, group, and virtual group levels. For solo practitioners and groups with 10 or fewer eligible clinicians (including at least one MIPS eligible clinician) that exceed at least one, but not all, of the elements of the low-volume threshold and are interested in participating in MIPS via the opt-in and doing so as part of a virtual group, such solo practitioners and groups will need to make an election to opt-in to participate in the MIPS. Therefore, beginning with the 2021 MIPS payment year, we proposed that a virtual group election would constitute a low-volume threshold opt-in for any prospective member of the virtual group (solo practitioner or group) that exceeds at least one, but not all, of the low-volume threshold criteria. As a result of the virtual group election, any such solo practitioner or group will be treated as a MIPS eligible clinician for the applicable MIPS payment year.
During the virtual group election process, the official virtual group representative of a virtual group submits an election to participate in the MIPS as a virtual group to CMS prior to the start of a performance period (82 FR 53601 through 53604). The submission of a virtual group election includes TIN and NPI information, which is the identification of TINs composing the virtual group and each member of the virtual group. As part of a virtual group election, the virtual group representative is required to confirm through acknowledgement that a formal written agreement is in place between each member of the virtual group (82 FR 53604). A virtual group may not include a solo practitioner or group as part of a virtual group unless an authorized person of the TIN has executed a formal written agreement.
For a solo practitioner or group that exceeds only one or two elements of the low-volume threshold, an election to opt-in to participate in the MIPS as part of a virtual group would be represented by being identified as a TIN that is included in the submission of a virtual group election. Such solo practitioners and groups opting-in to participate in the MIPS as part of a virtual group would not need to independently make a separate election to opt-in to participate in the MIPS. We note that being identified as a TIN in a submitted virtual group election, any such TIN (represented as a solo practitioner or group) that exceeds at least one, but not all, of the low-volume threshold elements during the MIPS determination period is signifying an election to opt-in to participate in MIPS as part of a virtual group and recognizing that a MIPS payment adjustment factor would be applied to any such TIN based on the final score of the virtual group. For a virtual group election that includes a TIN determined to exceed at least one, but not all, of the low-volume threshold elements during the MIPS determination period, such election would have a precedence over the eligibility determination made during the MIPS determination period pertaining to the low-volume threshold and as a result, any such TIN would be considered MIPS eligible and subject to a MIPS payment adjustment factor due the virtual group election. Furthermore, we note that a virtual group election would constitute an election to opt-in to participate in MIPS and any low-volume threshold determinations that result from segment 2 data analysis of the MIPS determination period would not have any bearing on the virtual group election. Thus, a TIN included as part of a virtual group election that submitted prior to the start of the applicable performance period and does not exceed at least one element of the low-volume threshold during segment 2 of the MIPS determination period, such TIN would be considered MIPS eligible and a virtual group participant by virtue of the virtual group's election to participate in MIPS as a virtual group that was made prior to the applicable performance period. For virtual groups with a composition that may only consist of solo practitioners and groups that exceed at least one, but not all of the low-volume threshold elements, such virtual groups are encouraged to form a virtual group that would include a sufficient number of TINs to ensure that such virtual groups are able to meet program requirements such as case minimum criteria that would allow measures to be scored. For example, if a virtual group does not have a sufficient number of cases to report for quality measures (minimum of 20 cases per measures), a virtual group would
We further noted that APM Entities in MIPS APMs, which meet one or two, but not all, of the low-volume threshold elements to opt-in and are interested in participating in MIPS under the APM scoring standard, would be required to make a definitive choice at the APM Entity level to opt-in to participate in MIPS. For such APM Entities to make an election to opt-in to MIPS, they would make an election via a similar process that individual eligible clinicians and groups will use to make an election to opt-in. Once the APM Entity has elected to participate in MIPS, the decision to opt-in to MIPS is irrevocable and cannot be changed for the performance period in which the data was submitted. Eligible clinicians in APM Entities in MIPS APMs that opt-in would be subject to the MIPS payment adjustment factor. APM Entities in MIPS APMs that do not decided to opt-in to MIPS cannot voluntarily report.
Additionally, we proposed for applicable eligible clinicians participating in a MIPS APM, whose APM Entity meets one or two, but not all, of the low-volume threshold elements rendering the option to opt-in and does not decide to opt-in to MIPS, that if their TIN or virtual group does elect to opt-in, it does not mean that the eligible clinician is opting-in on his/her own behalf, or on behalf of the APM Entity, but that the eligible clinician is still excluded from MIPS participation as part of the APM Entity even though such eligible clinician is part of a TIN or virtual group. This is necessary because low-volume threshold determinations are currently conducted at the APM Entity level for all applicable eligible clinicians in MIPS APMs, and therefore, the low-volume threshold opt-in option should similarly be executed at the APM Entity level rather than at the individual eligible clinician, TIN, or virtual group level. Thus, in order for an APM Entity to opt-in to participate in MIPS at the APM Entity level and for eligible clinicians within such APM Entity to be subject to the MIPS payment adjustment factor, an election would need to be made at the APM Entity level in a similar process that individual eligible clinicians and groups would use to make an election to opt-in to participate in MIPS.
We requested comments on our proposals: (1) To modify § 414.1305 for the low-volume threshold definition at paragraph (3) to specify that, beginning with the 2021 MIPS payment year, the low-volume threshold that applies to an individual eligible clinician or group that, during the MIPS determination period, has allowed charges for covered professional services less than or equal to $90,000, furnishes covered professional services to 200 or fewer Medicare Part B-enrolled individuals, or furnishes 200 or fewer covered professional services to Medicare Part B-enrolled individuals; (2) that a clinician who is eligible to opt-in would be required to make an affirmative election to opt-in to participate in MIPS, elect to be a voluntary reporter, or by not submitting any data the clinician is choosing to not report; and (3) to modify § 414.1310(b)(1)(iii) under Applicability to specify exclusions as follows: Beginning with the 2021 MIPS payment year, if an individual eligible clinician, group, or APM Entity group in a MIPS APM exceeds at least one, but not all, of the low-volume threshold criteria and elects to report on applicable measures and activities under MIPS, the individual eligible clinician, group, or APM Entity group is treated as a MIPS eligible clinician for the applicable MIPS payment year. For APM Entity groups in MIPS APMs, only the APM Entity group election can result in the APM Entity group being treated as MIPS eligible clinicians for the applicable payment year.
The following is a summary of the public comments received on our proposals and our responses:
After consideration of the public comments received, we are finalizing our proposals: (1) To modify § 414.1305 for the low-volume threshold definition at paragraph (3) to specify that, beginning with the 2021 MIPS payment year, the low-volume threshold that applies to an individual eligible clinician, group, or APM Entity group that, during the MIPS determination period, has allowed charges for covered professional services less than or equal to $90,000, furnishes covered professional services to 200 or fewer Medicare Part B-enrolled individuals, or furnishes 200 or fewer covered professional services to Medicare Part B-enrolled individuals; (2) that a clinician who is eligible to opt-in would be required to make an affirmative election to opt-in to participate in MIPS, elect to be a voluntary reporter, or by not submitting any data the clinician is choosing to not report; and (3) to modify § 414.1310(b)(1)(iii) under Applicability to specify exclusions as follows: Beginning with the 2021 MIPS payment year, if an individual eligible clinician, group, or APM Entity group in a MIPS APM exceeds at least one, but not all, of the low-volume threshold criteria and elects to report on applicable measures and activities under MIPS, the individual eligible clinician, group, or APM Entity group is treated as a MIPS eligible clinician for the applicable MIPS payment year. For such solo practitioners and groups that elect to participate in MIPS as a virtual group (except for APM Entity groups in MIPS APMs), the virtual group election under § 414.1315 constitutes an election under this paragraph and results in the solo practitioners and groups being treated as MIPS eligible clinicians for the applicable MIPS payment year. For such APM Entity groups in MIPS APMs, only the APM Entity group election can constitute an election under this paragraph and result in the APM Entity group being treated as MIPS eligible clinicians for the applicable MIPS payment year. We note that a virtual group election does not constitute a Partial QP election under revised § 414.1310(b)(1)(ii). In order for an individual eligible clinician or APM Entity with a Partial QP status to explicitly elect to participate in MIPS and be subject to the MIPS payment adjustment factor, such individual eligible clinician or APM Entity would make such election during the applicable performance period as a Partial QP status becomes applicable and such option for election is warranted.
Section 1848(q)(6)(E) of the Act, as amended by section 51003(a)(1)(E) of the Bipartisan Budget Act of 2018, provides that the MIPS adjustment factor and, as applicable, the additional MIPS adjustment factor, apply to the amount otherwise paid under Part B with respect to covered professional services (as defined in subsection (k)(3)(A) of the Act) furnished by a MIPS eligible clinician during a year (beginning with 2019) and with respect to the MIPS eligible clinician for such year.
In the CY 2019 PFS proposed rule (83 FR 35890), we requested comments on our proposal to amend § 414.1405(e) to modify the application of both the MIPS adjustment factor and, if applicable, the additional MIPS adjustment factor so that beginning with the 2019 MIPS payment year, these adjustment factors will apply to Part B payments for covered professional services (as defined in section 1848(k)(3)(A) of the Act) furnished by the MIPS eligible clinician during the year. We are making this change beginning with the first MIPS payment year and note that these adjustment factors will not apply to Part B drugs and other items furnished by a MIPS eligible clinician, but will apply to covered professional services furnished by a MIPS eligible clinician. We refer readers to section III.I.3.j. of this final rule for further details on this modification.
The following is a summary of the public comments received on our proposals and our responses:
After consideration of the public comments received, we are finalizing our proposal to amend § 414.1405(e) to modify the application of both the MIPS adjustment factor and, if applicable, the additional MIPS adjustment factor so that beginning with the 2019 MIPS payment year, these adjustment factors will apply to Part B payments for covered professional services (as defined in section 1848(k)(3)(A) of the Act) furnished by the MIPS eligible clinician during the year. We are making this change beginning with the first MIPS payment year and note that these adjustment factors will not apply to Part B drugs and other items furnished by a MIPS eligible clinician, but will apply to covered professional services furnished by a MIPS eligible clinician.
In the CY 2017 Quality Payment Program final rule, we finalized that following a determination that eligible clinicians in an APM Entity group in an Advanced APM are Partial QPs for a year, the APM Entity will make an election whether to report on applicable measures and activities as required under MIPS. If the APM Entity elects to report to MIPS, all eligible clinicians in
We also finalized that in cases where the Partial QP determination is made at the individual eligible clinician level, if the individual eligible clinician is determined to be a Partial QP, the eligible clinician will make the election whether to report on applicable measures and activities as required under MIPS and, as a result, be subject to the MIPS reporting requirements and payment adjustments (81 FR 77449). If the individual eligible clinician elects to report to MIPS, he or she would be subject to the MIPS reporting requirements and payment adjustments for the relevant year. If the individual eligible elects not to report to MIPS, he or she will be excluded from the MIPS reporting requirements and payment adjustments for the relevant year.
We also clarified how we consider the absence of an explicit election to report to MIPS or to be excluded from MIPS. We finalized that for situations in which the APM Entity is responsible for making the decision on behalf of all eligible clinicians in the APM Entity group, the group of Partial QPs will not be considered MIPS eligible clinicians unless the APM Entity opts the group into MIPS participation, so that no actions other than the APM Entity's election for the group to participate in MIPS would result in MIPS participation (81 FR 77449). For eligible clinicians who are determined to be Partial QPs individually, we finalized that we will use the eligible clinician's actual MIPS reporting activity to determine whether to exclude the Partial QP from MIPS in the absence of an explicit election. Therefore, if an eligible clinician who is individually determined to be a Partial QP submits information to MIPS (not including information automatically populated or calculated by CMS on the Partial QP's behalf), we will consider the Partial QP to have reported, and thus to be participating in MIPS. Likewise, if such an individual does not take any action to submit information to MIPS, we will consider the Partial QP to have elected to be excluded from MIPS (81 FR 77449).
In the CY 2018 Quality Payment Program final rule, we clarified that in the case of an eligible clinician participating in both a virtual group and an Advanced APM who has achieved Partial QP status, that the eligible clinician would be excluded from the MIPS payment adjustment unless the eligible clinician elects to report under MIPS (82 FR 53615). As discussed in the CY 2019 PFS proposed rule (83 FR 35890 through 35891), we incorrectly stated that affirmatively agreeing to participate in MIPS as part of a virtual group prior to the start of the applicable performance period would constitute an explicit election to report under MIPS for all Partial QPs. As such, we also incorrectly stated that all eligible clinicians who participate in a virtual group and achieve Partial QP status would remain subject to the MIPS payment adjustment due to their virtual group election to report under MIPS, regardless of their Partial QP election. We note that an election made prior to the start of an applicable performance period to participate in MIPS as part of a virtual group is separate from an election made during the performance period that is warranted as a result of an individual eligible clinician or APM Entity achieving Partial QP status during the applicable performance period. A virtual group election does not equate to an individual eligible clinician or APM Entity with a Partial QP status explicitly electing to participate in MIPS. In order for an individual eligible clinician or APM Entity with a Partial QP status to explicitly elect to participate in MIPS and be subject to the MIPS payment adjustment factor, such individual eligible clinician or APM Entity would make such election during the applicable performance period as a Partial QP status becomes applicable and such option for election is warranted. Thus, we are restating that affirmatively agreeing to participate in MIPS as part of a virtual group prior to the start of the applicable performance period does not constitute an explicit election to report under MIPS as it pertains to making an explicit election to either report to MIPS or be excluded from MIPS for individual eligible clinicians or APM Entities that have Partial QP status.
Related to this clarification, we are finalizing in section III.I.4.e.(3) of this final rule to clarify that beginning with the 2021 MIPS payment year, when an eligible clinician is determined to be a Partial QP for a year at the individual eligible clinician level, the individual eligible clinician has the option to make an election whether to report to MIPS. If the eligible clinician elects to report to MIPS, he or she will be subject to MIPS reporting requirements and payment adjustments. If the eligible clinician elects to not report to MIPS, he or she will not be subject to MIPS reporting requirements and payment adjustments. If the eligible clinician does not make any affirmatively election to report to MIPS, he or she will not be subject to MIPS reporting requirements and payment adjustments. As a result, beginning with the 2021 MIPS payment year, for eligible clinicians who are determined to be Partial QPs individually, we will not use the eligible clinician's actual MIPS reporting activity to determine whether to exclude the Partial QP from MIPS in the absence of an explicit election.
Therefore, the finalized policy in section III.I.4.e.(3) of this final rule eliminates the scenario in which affirmatively agreeing to participate in MIPS as part of a virtual group prior to the start of the applicable performance period will constitute an explicit election to report under MIPS for eligible clinicians who are determined to be Partial QPs individually and make no explicit election to either report to MIPS or be excluded from MIPS. We believe this change is necessary because QP status and Partial QP status, achieved at the APM Entity level or eligible clinician level, is applied to an individual and all of his or her TIN/NPI combinations, whereas virtual group participation is determined at the TIN level. Therefore, we do not believe that it is appropriate that the actions of the TIN in joining the virtual group should deprive the eligible clinician who is a Partial QP, whether that status was achieved at APM Entity level or eligible clinician level, of the opportunity to elect whether or not to opt-in to MIPS.
We refer readers to § 414.1310(e) and the CY 2018 Quality Payment Program final rule (82 FR 53592 through 53593) for a description of our previously established policies regarding group reporting.
In the CY 2018 Quality Payment Program final rule (82 FR 53593), we clarified 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 further clarify that we consider a group to be an entire single TIN that chooses to participate in MIPS at the group level. However, individual eligible clinicians (TIN/NPIs) within that group may receive a MIPS payment adjustment
As discussed in the CY 2018 Quality Payment Program final rule (82 FR 53593), one of the overarching themes we have heard from stakeholders is that we make an option available to groups that would allow a portion of a group to report as a separate sub-group on measures and activities that are more applicable to the sub-group and be assessed and scored accordingly based on the performance of the sub-group. We stated that in future rulemaking, we intend to explore the feasibility of establishing group-related policies that would permit participation in MIPS at a sub-group level and create such functionality through a new identifier. In the CY 2018 Quality Payment Program proposed rule (82 FR 30027), we solicited public comments on the ways in which participation in MIPS at the sub-group level could be established. In addition, in the CY 2018 Quality Payment Program final rule (82 FR 53593), we sought comment on additional ways to define a group, not solely based on a TIN. Because there are several operational challenges with implementing a sub-group option, we did not propose any such changes to our established reporting policies in this final rule. Rather, we are considering facilitating the use of a sub-group identifier in the Quality Payment Program Year 4 through future rulemaking, as necessary. In addition, it has come to our attention that providing a sub-group option may provide potential gaming opportunities. For example, a group could manipulate scoring by creating sub-groups that are comprised of only the high performing clinicians in the group. Therefore, we requested comment on implementing sub-group level reporting through a separate sub-group sub-identifier in the Quality Payment Program Year 4 and possibly future years of the program.
In the CY 2019 PFS proposed rule (83 FR 35891) we requested comments on the following: (1) Whether and how a sub-group should be treated as a separate group from the primary group: For example, if there is 1 sub-group within a group, how would we assess eligibility, performance, scoring, and application of the MIPS payment adjustment at the sub-group level; (2) whether all of the sub-group's MIPS performance data should be aggregated with that of the primary group or should be treated as a distinct entity for determining the sub-group's final score, MIPS payment adjustments, and public reporting, and eligibility be determined at the whole group level; (3) possible low burden solutions for identification of sub-groups: For example, whether we should require registration similar to the CMS Web Interface or a similar mechanism to the low-volume threshold opt-in that we proposed and is discussed in section III.I.3.c.(5) of this final rule; and (4) potential issues or solutions needed for sub-groups utilizing submission mechanisms, measures, or activities, such as APM participation, that are different than the primary group. We also welcomed comments on other approaches for sub-group reporting that we should consider. We received many comments on group reporting and will take them into consideration for future rulemaking.
We refer readers to § 414.1315 and the CY 2018 Quality Payment Program final rule (82 FR 53593 through 53617) for our previously established policies regarding virtual groups.
We refer readers to § 414.1315(c) and the CY 2018 Quality Payment Program final rule (82 FR 53601 through 53604) for our previously established policies regarding the virtual group election process.
We proposed to amend § 414.1315(c) to continue to apply the previously established policies regarding the virtual group election process for the 2022 MIPS payment year and future years, with the exception of the proposed policy modification discussed below (83 FR 35891 through 35892).
Under § 414.1315(c)(2)(ii), an official designated virtual group representative must submit an election on behalf of the virtual group by December 31 of the calendar year prior to the start of the applicable performance period. In the CY 2018 Quality Payment Program final rule (82 FR 53603), we stated that 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:
We solicited public comment on this proposal, which would provide for an election to occur in a manner specified by CMS such as a web-based system developed by CMS.
The following is a summary of the public comments received regarding the proposal to continue to apply the previously established policies regarding the virtual group election process for the 2022 MIPS payment year and future years, with the exception of providing for an election to occur in a manner specified by CMS, such as a web-based system developed by CMS, and our responses.
After consideration of the public comments, we are finalizing our proposal at § 414.1315(c) to continue to apply the previously established policies regarding the virtual group election process for the 2022 MIPS payment year and future years, with the exception of providing for an election to occur in a manner specified by CMS, such as a web-based system developed by CMS.
For purposes of determining TIN size for virtual group participation eligibility for the CY 2018 and 2019 performance periods, 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 (82 FR 53602). We proposed to modify the virtual group eligibility determination period beginning with the 2019 performance period (83 FR 35892 through 35893). We proposed to amend § 414.1315(c)(1) to establish a virtual group eligibility determination period to mean an analysis of claims data during a 12-month assessment period (fiscal year) that would begin on October 1 of the calendar year 2 years prior to the applicable performance period and end on September 30 of the calendar year preceding the applicable performance period and include a 30-day claims run out. The virtual group eligibility determination period aligns with the first segment of data analysis under the MIPS eligibility determination period. As part of the virtual group eligibility determination period, TINs would be able to inquire about their TIN size prior to making an election during a 5-month timeframe, which would begin on August 1 and end on December 31 of a calendar year prior to the applicable performance period. TIN size inquiries would be made through the Quality Payment Program Service Center. For TINs that inquire about their TIN size during such 5-month timeframe, it should be noted that any TIN size information provided is only for informational purposes and may be subject to change; official eligibility regarding TIN size and all other eligibility pertaining to virtual groups would be determined in accordance with the MIPS determination period and other applicable special status eligibility determination periods. The proposed modification would provide stakeholders with real-time information regarding TIN size for informational purposes instead of TIN size eligibility determinations on an ongoing basis (between July 1 and November 30 of the calendar year prior to the applicable performance period) due to technical limitations.
For the 2018 and 2019 performance periods, TINs could determine their status by contacting their designated TA representative as provided at § 414.1315(c)(1); otherwise, the TIN's status would be determined at the time that the TIN's virtual group election is submitted. We proposed to amend § 414.1315(c)(1) to remove this provision since the inquiry about TIN size would be for informational purposes only and may be subject to change.
We believe that the utilization of the Quality Payment Program Service Center, versus the utilization of designated TA representatives, as the means for stakeholders to obtain information regarding TIN size provides continuity and a seamless experience for stakeholders. We note that the TA resources already available to stakeholders would continue to be available. The following describes the experience a stakeholder would encounter when interacting with the Quality Payment Program Service Center to obtain information pertaining to TIN size. For example, the applicable performance period for the 2022 MIPS payment year would be CY 2020. If a group contacted the Quality Payment Program Service Center on September 20, 2019, the claims data analysis would include the months of October of 2018 through August of 2019. If another group contacted the Quality Payment Program Service Center on November 20, 2019, the claims data analysis would include the months of October of 2018 through September of 2019 with a 30-day claims run out.
We believe this virtual group eligibility determination period provides a real-time representation of TIN size for purposes of determining virtual group eligibility and allows solo practitioners and groups to know their real-time virtual group eligibility status and plan accordingly for virtual group implementation. Beginning with the 2022 MIPS payment year, it is anticipated that starting in August of each calendar year prior to the applicable performance period, solo practitioners and groups would be able to contact the Quality Payment Program Service Center and inquire about their TIN size. TIN size determinations would be based on the number of NPIs associated with a TIN, which may 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).
We proposed to continue to apply the aforementioned previously established virtual group policies for the 2022 MIPS payment year and future years, with the exception of the following policy modifications:
• The virtual group eligibility determination period would align with the first segment of the MIPS determination period, which includes an analysis of claims data during a 12-month assessment period (fiscal year) that would begin on October 1 of the calendar year 2 years prior to the applicable performance period and end on September 30 of the calendar year preceding the applicable performance period and include a 30-day claims run out. As part of the virtual group eligibility determination period, TINs would be able to inquire about their TIN size prior to making an election during a 5-month timeframe, which would begin on August 1 and end on December 31 of a calendar year prior to the applicable performance period.
• MIPS eligible clinicians would be able to contact their designated technical assistance representative or, beginning with the 2022 MIPS payment year, the Quality Payment Program Service Center, as applicable, to inquire about their TIN size for informational purposes in order to assist MIPS eligible clinicians in determining whether or not to participate in MIPS as part of a virtual group. We anticipate that starting in August of each calendar year prior to the applicable performance period, solo practitioners and groups would be able to contact the Quality Payment Program
• A virtual group representative would make an election on behalf of a virtual group by registering to participate in MIPS as a virtual group in a form and manner specified by CMS. We anticipate that a virtual group representative would make the election via a web-based system developed by CMS.
We also proposed updates to § 414.1315 in an effort to more clearly and concisely capture previously established policies. These proposed updates are not intended to be substantive in nature, but rather to bring more clarity to the regulatory text.
The following is a summary of the public comments received on these proposals and our responses.
Furthermore, we note that given that the TIN size is already based on the total number of NPIs within a TIN, the expanded definition of a MIPS eligible clinician will not impact the population of TINs eligible to form or join a virtual group. In regard to increasing the TIN size threshold of 10, section 1848(q)(5)(I)(ii) of the Act establishes a threshold of 10 and as a result, we do not have discretion to expand virtual group participation to TINs with more than 10 NPIs.
After consideration of the public comments, we are finalizing our proposals to continue to apply the aforementioned previously established virtual group policies for the 2022 MIPS payment year and future years, with the exception of the following:
• The virtual group eligibility determination period is the first segment of the MIPS determination period (proposal finalized at § 414.1315(c)(1)(ii)), which consists of an analysis of claims data during a 12-month assessment period (fiscal year) that begins on October 1 of the calendar year 2 years prior to the applicable performance period and ends on September 30 of the calendar year preceding the applicable performance period and includes a 30-day claims run out. As part of the virtual group eligibility determination period, TINs will be able to inquire about their TIN size prior to making an election during a 5-month timeframe, which will begin on August 1 and end on December 31 of a calendar year prior to the applicable performance period. We refer readers to section III.I.3.b. of this final rule for more information regarding the MIPS determination period.
• MIPS eligible clinicians will be able to contact their designated technical assistance representative or, beginning with the 2022 MIPS payment year, the Quality Payment Program Service Center, as applicable, to inquire about their TIN size for informational purposes in order to assist MIPS eligible clinicians in determining whether or not to participate in MIPS as part of a virtual group. We anticipate that starting in August of each calendar year prior to the applicable performance period, solo practitioners and groups would be able to contact the Quality Payment Program Service Center and inquire about virtual group participation eligibility.
• A designated virtual group representative must submit an election, on behalf of the solo practitioners and groups that compose a virtual group, to participate in MIPS as a virtual group for a performance period in a form and manner specified by CMS by the election deadline specified at § 414.1315(b) (proposal finalized at § 414.1315(c)(2)(ii)) We anticipate that a virtual group representative will make the election via a web-based system developed by CMS.
Also, we are finalizing updates to § 414.1315 in an effort to more clearly and concisely capture previously established policies. The updates are not intended to be substantive in nature, but rather to bring more clarity to the regulatory text.
We note that we are further revising § 414.1315 to consolidate paragraphs (c)(2)(ii) and (iii) and redesignate paragraph (c)(2)(iv) as paragraph (c)(2)(iii) for clarity. Additionally, we are revising redesignated paragraph
In the CY 2018 Quality Payment Program final rule (82 FR 53617 through 53619), we finalized at § 414.1320(c)(1) 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 did not finalize the performance period for the quality and cost performance categories for purposes of the 2022 MIPS payment year or future years. We also redesignated § 414.1320(d)(1) and finalized at § 414.1320(c)(2) that for purposes of the 2021 MIPS payment year, the performance period for the Promoting Interoperability 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).
As noted in the CY 2018 Quality Payment Program final rule, we received comments that were not supportive of a full calendar year performance period for the quality and cost performance categories. However, we continue to believe that a full calendar year performance period for the quality and cost performance categories will be less confusing for MIPS eligible clinicians. As discussed in the CY 2019 PFS proposed rule (83 FR 35893), we believe that a longer performance period for the quality and cost performance categories will likely include more patient encounters, which will increase the denominator of the quality and cost measures. Statistically, larger sample sizes provide more accurate and actionable information. Additionally, a full calendar year performance period is consistent with how many of the measures used in our program were designed to be performed and reported. We also noted that the Bipartisan Budget Act of 2018 (Pub. L. 115-119, enacted February 9, 2018) has provided further flexibility to the 3rd, 4th, and 5th years of MIPS to help continue the gradual transition to MIPS.
Regarding the Promoting Interoperability performance category, we have heard from stakeholders through public comments, letters, and listening sessions that they oppose a full year performance period, indicating that it is very challenging and may add administrative burdens (83 FR 35893). Some stated that a 90-day performance period is necessary in order to enable clinicians to have a greater focus on the objectives and measures that promote patient safety, support clinical effectiveness, and drive toward advanced use of health IT. They also noted that as this performance category requires the use of CEHRT, a 90-day performance period will help relieve pressure on clinicians to quickly implement changes and updates from their CEHRT vendors and developers so that patient care is not compromised. Others cited the challenges associated with reporting on a full calendar year for clinicians newly employed by a health system or practice during the course of a program year, switching CEHRT, vendor issues, system downtime, cyber-attacks, difficulty getting data from old places of employment, and office relocation. Most stakeholders stated that the performance period should be 90 days in perpetuity, as this would greatly reduce the reporting burden (83 FR 35893).
In the CY 2019 PFS proposed rule (83 FR 35893), in an effort to provide as much transparency as possible so that MIPS eligible clinicians and groups may plan for participation in the program, we requested comments on our proposals at § 414.1320(d)(1) that for purposes of the 2022 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 MIPS payment year. For example, for the 2022 MIPS payment year, the performance period would be 2020 (January 1, 2020 through December 31, 2020), and for the 2023 MIPS payment year, the performance period would be CY 2021 (January 1, 2021 through December 31, 2021).
In addition, we requested comments on our proposal at § 414.1320(d)(2) that for purposes of the 2022 MIPS payment year and future years, the performance period for the improvement activities performance category would be a minimum of a continuous 90-day period within the calendar year that occurs 2 years prior to the applicable MIPS payment year, up to and including the full calendar year. For example, for the 2022 MIPS payment year, the performance period for the improvement activities performance category would be a minimum of a continuous 90-day period within CY 2020, up to and including the full CY 2020 (January 1, 2020 through December 31, 2020). For the 2023 MIPS payment year, the performance period for the improvement activities performance category would be a minimum of a continuous 90-day period within CY 2021, up to and including the full CY 2021 (January 1, 2021 through December 31, 2021) that occurs 2 years before the MIPS payment year (83 FR 35893).
Finally, we requested comments on our proposal to add § 414.1320(e)(1) that for purposes of the 2022 MIPS payment year, the performance period for the Promoting Interoperability performance category would be a minimum of a continuous 90-day period within the calendar year that occurs 2 years prior to the applicable MIPS payment year, up to and including the full calendar year. Thus, for the 2022 MIPS payment year, the performance period for the Promoting Interoperability performance category would be a minimum of a continuous 90-day period within CY 2020, up to and including the full CY 2020 (January 1, 2020 through December 31, 2020) (83 FR 35893).
The following is a summary of the public comments received on these proposals and our responses:
After consideration of the public comments received, we are finalizing our proposal at § 414.1320(d)(1) that for purposes of the 2022 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 MIPS payment year. In addition, we are finalizing our proposal at § 414.1320(d)(2) that for purposes of the 2022 MIPS payment year and future years, the performance period for the improvement activities performance category would be a minimum of a continuous 90-day period within the calendar year that occurs 2 years prior to the applicable MIPS payment year, up to and including the full calendar year. We are also finalizing our proposal to add at § 414.1320(e)(1) that for purposes of the 2022 MIPS payment year, the performance period for the Promoting Interoperability performance category would be a minimum of a continuous 90-day period within the calendar year that occurs 2 years prior to the applicable MIPS payment year, up to and including the full calendar year. Finally, we are finalizing revisions to § 414.1320(b)(2) and (c)(2) to refer to the new name of the Promoting Interoperability performance category.
We refer readers to § 414.1325 and the CY 2017 and CY 2018 Quality Payment Program final rules (81 FR 77087 through 77095, and 82 FR 53619 through 53626, respectively) for our previously established policies regarding data submission requirements.
It has come to our attention that the way we have previously described data submission by MIPS eligible clinicians, groups and third party intermediaries does not precisely reflect the experience users have when submitting data to us. To clarify, we have previously used the term “submission mechanisms” to refer not only to the mechanism by which data is submitted, but also to certain types of measures and activities on which data are submitted (for example, electronic clinical quality measures (eCQMs) reported via EHR) and to the entities submitting such data (for example, third party intermediaries on behalf of MIPS eligible clinicians and groups). To ensure clarity and precision for all users, we are proposing to revise existing and define additional terminology to more precisely reflect the experience users have when submitting data to the Quality Payment Program.
In the CY 2019 PFS proposed rule (83 FR 35894), we requested comments on our proposal to define the following terms at § 414.1305:
• Collection type as a set of quality measures with comparable specifications and data completeness criteria, including, as applicable: eCQMs; MIPS Clinical Quality Measures (MIPS CQMs); QCDR measures; Medicare Part B claims measures; CMS Web Interface measures; the CAHPS for MIPS survey; and administrative claims measures. The term MIPS CQMs would replace what was formerly referred to as registry measures since entities other than registries may submit data on these measures. These new terms are referenced in the collection type field for the following measure tables of the appendices in the CY 2019 PFS proposed rule (83 FR 36092 through 36358): Table Group A: Proposed New Quality Measures for Inclusion in MIPS for the 2021 MIPS Payment Year and Future Years; Table Group B: Proposed New and Modified MIPS Specialty Measure Sets for the 2021 MIPS Payment Year and Future Years; Table C: Quality Measures Proposed for Removal from the Merit-Based Incentive Payment System Program for the 2019 Performance Period and Future Years; and Table Group D: Measures with Substantive Changes Proposed for the 2021 MIPS Payment Year and Future Years.
• Submitter type as the MIPS eligible clinician, group, or third party intermediary acting on behalf of a MIPS eligible clinician or group, as applicable, that submits data on measures and activities under MIPS.
• Submission type as the mechanism by which a submitter type submits data to CMS, including, as applicable: Direct, log in and upload, log in and attest, Medicare Part B claims and the CMS Web Interface. The direct submission type allows users to transmit data through a computer-to-computer interaction, such as an API. The log in and upload submission type allows users to upload and submit data in the form and manner specified by CMS with a set of authenticated credentials. The log in and attest submission type allows users to manually attest that certain measures and activities were performed in the form and manner specified by CMS with a set of authenticated credentials. We note that there is no submission type for the administrative claims collection type because we calculate measures for this collection type based on administrative claims data available to us.
In the CY 2019 PFS proposed rule (83 FR 35894), we solicited additional feedback and alternative suggestions on terminology that appropriately reflects the concepts described in the proposed definitions of collection type, submitter type and submission type, as well as the term MIPS CQMs to replace the formerly used term of registry measures.
The following is a summary of the comments we received on “Collection Types, Submission Types and Submitter Types”.
After consideration of the public comments received, we are finalizing our proposal at § 414.1305 to define the following terms:
• Collection type as a set of quality measures with comparable specifications and data completeness criteria, including, as applicable: eCQMs; MIPS Clinical Quality Measures (MIPS CQMs); QCDR measures; Medicare Part B claims measures; CMS Web Interface measures; the CAHPS for MIPS survey; and administrative claims measures. The term MIPS CQMs would replace what was formerly referred to as registry measures since entities other than registries may submit data on these measures. These new terms are referenced in the collection type field for the following measure tables of “Appendix 1: Finalized MIPS Quality
• Submitter type as the MIPS eligible clinician, group, or third party intermediary acting on behalf of a MIPS eligible clinician or group, as applicable, that submits data on measures and activities under MIPS.
• Submission type as the mechanism by which a submitter type submits data to CMS, including, as applicable: Direct, log in and upload, log in and attest, Medicare Part B claims and the CMS Web Interface. The direct submission type allows users to transmit data through a computer-to-computer interaction, such as an API. The log in and upload submission type allows users to upload and submit data in the form and manner specified by CMS with a set of authenticated credentials. The log in and attest submission type allows users to manually attest that certain measures and activities were performed in the form and manner specified by CMS with a set of authenticated credentials. We note that there is no submission type for the administrative claims collection type because we calculate measures for this collection type based on administrative claims data available to us.
We previously finalized at § 414.1325(a) and (e), respectively, that MIPS eligible clinicians and groups must submit measures, objectives, and activities for the quality, improvement activities, and advancing care information performance categories and that there are no data submission requirements for the cost performance category and for certain quality measures used to assess performance in the quality performance category; CMS will calculate performance on these measures using administrative claims data. In the CY 2019 PFS proposed rule (83 FR 35894), we proposed to amend § 414.1325(a) to incorporate § 414.1325(e), as they both address which performance categories require data submission; § 414.1325(f) would be redesignated as § 414.1325(e). We also proposed in the CY 2019 PFS proposed rule (83 FR 35894) at § 414.1325(a)(2)(ii) that there is no data submission requirement for the quality or cost performance category, as applicable, for MIPS eligible clinicians and groups that are scored under the facility-based measurement scoring methodology described in § 414.1380(e). We also recognized the need to clarify to users how they submit data to us. In the CY 2019 PFS proposed rule (83 FR 35894), there are five basic submission types that we proposed to define in MIPS: Direct; log in and upload; login and attest; Medicare Part B claims; and the CMS Web Interface. We proposed to reorganize § 414.1325(b) and (c) by performance category in the CY 2019 PFS proposed rule (83 FR 35894). We proposed in the CY 2019 PFS proposed rule (83 FR 35894) to also clarify at § 414.1325(b)(1) that an individual MIPS eligible clinician may submit their MIPS data for the quality performance category using the direct, login and upload, and Medicare Part B claims submission types. In the CY 2019 PFS proposed rule (83 FR 35894), similarly, we proposed to clarify at § 414.1325(b)(2) that an individual MIPS eligible clinician may submit their MIPS data for the improvement activities or Promoting Interoperability performance categories using the direct, login and upload, or login and attest submission types. As for groups, we proposed in the CY 2019 PFS proposed rule (83 FR 35894) to clarify at § 414.1325(c)(1) that groups may submit their MIPS data for the quality performance category using the direct, login and upload, and CMS Web Interface (for groups consisting of 25 or more eligible clinicians) submission types. Lastly, we proposed to clarify at § 414.1325(c)(2) that groups may submit their MIPS data for the improvement activities or Promoting Interoperability performance categories using the direct, login and upload, or login and attest submission types in the CY 2019 PFS proposed rule (83 FR 35894). We believe that these clarifications will enhance the submission experience for clinicians and other stakeholders. As technology continues to evolve, we will continue to look for new ways that we can offer further technical flexibilities on submitting data to the Quality Payment Program. In the CY 2019 PFS proposed rule (83 FR 35894), we requested comment on these proposals. To assist commenters in providing pertinent comments, we developed a website that uses wireframe (schematic) drawings to illustrate a subset of the different submission types available for MIPS participation. Specifically, the wireframe drawings describe the direct, login and attest, and login and upload submission types. We refer readers to the Quality Payment Program at
As previously expressed in the 2017 Quality Payment Program final rule (81 FR 77090), we want to move away from claims reporting, since approximately 69 percent of the Medicare Part B claims measures are topped out. Although we would like to move towards the utilization of electronic reporting by all clinicians and groups, we realize that small practices face additional challenges, and this requirement may limit their ability to participate. For this reason, we believe that Medicare Part B claims measures should be available to small practices, regardless of whether they are reporting as individual MIPS eligible clinicians or as groups. Therefore, we proposed amending § 414.1325(c)(1) to make the Medicare Part B claims collection type available to MIPS eligible clinicians in small practices beginning with the 2021 MIPS payment year in the CY 2019 PFS proposed rule (83 FR 35894). Although this will limit the current availability of Medicare Part B claims measures for individual MIPS eligible clinicians that do not meet the definition of a small practice, it will expand the availability of such measures for small practices who choose to participate in MIPS as a group, which currently does not have a claims-based reporting option as a group.
Under § 414.1325(c)(4), we previously finalized that groups may submit their MIPS data using the CMS Web Interface (for groups consisting of 25 or more eligible clinicians) for the quality, improvement activities, and promoting interoperability performance categories. In the CY 2019 PFS proposed rule (83 FR 35894 through 35895), we proposed that the CMS Web Interface submission type would no longer be available for groups to use to submit data for the improvement activities and Promoting Interoperability performance categories at § 414.1325(c)(2). The CMS Web Interface has been designed based on user feedback as a method for quality submissions only; however, groups that elect to utilize the CMS Web Interface can still submit improvement activities or promoting interoperability data via direct, log in and attest or log in and upload submission types. We also recognized that certain groups that have elected to use the CMS Web Interface
We previously finalized at § 414.1325(e) that there are no data submission requirements for the cost performance category and for certain quality measures used to assess performance in the quality performance category and that CMS will calculate performance on these measures using administrative claims data. We also finalized at § 414.1325(f)(2), (which, as noted, we proposed to redesignate as § 414.1325(e)(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. We neglected to codify this requirement at § 414.1325(e) (which, as noted, we proposed to consolidate with § 414.1325(a)) for administrative claims data used to assess performance in the cost performance category and for administrative claims-based quality measures. Therefore, in the CY 2019 PFS proposed rule (83 FR 35895), we proposed to amend § 414.1325(a)(2)(i) to reflect that claims included in the measures are those submitted with dates of service during the performance period that are processed no later than 60 days following the close of the performance period.
In the CY 2019 PFS proposed rule (83 FR 35895), a summary of these proposed changes is included in Tables 32 and 33. For reference, Table 32 summarizes the data submission types for individual MIPS eligible clinicians that we proposed at § 414.1325(b) and (e) in the CY 2019 PFS proposed rule (83 FR 35895). Table 33 summarizes the data submission types for groups that we proposed at § 414.1325(c) and (e) in the CY 2019 PFS proposed rule (83 FR 35895 through 35896). We requested comment on these proposals.
The following is a summary of the comments we received on “Performance Category Measures and Reporting”.
We agree that choosing to report topped out measures is not incentivized. As discussed in the CY 2019 PFS proposed rule (83 FR 35894), we want to move away from claims reporting, since approximately 69 percent of the Medicare Part B claims measures are topped out. This is a contributing factor as to why we are looking to decrease the usage of this option over time, as we have been signaling we would do for many years. We will continue to work with stakeholders on providing further transparency of the future of this collection type. It is unclear to what reference the commenter is discussing where the removal of claims reporting is a contradiction to provisions made in the Bipartisan Budget Act of 2018. We do not believe that this proposal is inconsistent with the Bipartisan Budget Act of 2018.
We do not believe further delay is warranted but will continue to work with stakeholders to provide further clarity on the future of this collection type. Lastly, we disagree that the expansion of the MIPS eligible clinician type as discussed in section III.I.3.c. will decrease the number of small practices. As defined at § 414.1305, a small practice is a TIN consisting of 15 or fewer eligible clinicians during the MIPS determination period. We note that this definition currently includes both eligible clinicians and MIPS eligible clinicians, and therefore, the expansion of the MIPS eligible clinician definition should not negatively impact a practice's ability to be considered a small practice.
After consideration of the public comments received, we are finalizing our proposal to amend § 414.1325(a) to incorporate § 414.1325(e), as they both address which performance categories require data submission; § 414.1325(f) will be redesignated as § 414.1325(e). We are finalizing our proposal at § 414.1325(a)(2)(ii) that there is no data submission requirement for the quality or cost performance category, as applicable, for MIPS eligible clinicians and groups that are scored under the facility-based measurement scoring methodology described in § 414.1380(e). We are finalizing our proposals to reorganize § 414.1325(b) and (c) by performance category and to clarify at § 414.1325(b)(1) that an individual MIPS eligible clinician may submit their MIPS data for the quality performance category using the direct, login and upload, and Medicare Part B claims submission types. We are finalizing our proposal to clarify at § 414.1325(b)(2) that an individual MIPS eligible clinician may submit their MIPS data for the improvement activities or Promoting Interoperability performance categories using the direct, login and upload, or login and attest submission types. We are finalizing our proposal to clarify at § 414.1325(c)(1) that groups may submit their MIPS data for the quality performance category using the direct, login and upload, and CMS Web Interface (for groups consisting of 25 or more eligible clinicians) submission types. We are also finalizing our proposal to clarify at § 414.1325(c)(2) that groups may submit their MIPS data for the improvement activities or Promoting Interoperability performance categories using the direct, login and upload, or login and attest submission types. We are finalizing our proposal to amend § 414.1325(c)(1) to make the Medicare Part B claims collection type available to MIPS eligible clinicians in small practices beginning with the 2021 MIPS payment year. We are finalizing our proposal at § 414.1325(c)(2) to state that the CMS Web Interface submission type will no longer be available for groups to use to submit data for the improvement activities and Promoting Interoperability performance categories. We are finalizing our proposal to redesignate § 414.1325(c)(4) as § 414.1325(c)(1) and amend § 414.1325(c)(1) to allow third party intermediaries to submit data using the CMS Web Interface on behalf of groups. We are finalizing our proposal to redesignate § 414.1325(f)(2) as § 414.1325(e)(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. Lastly, we are also finalizing our proposal to amend § 414.1325(a)(2)(i) to reflect that claims included in the measures are those submitted with dates of service during the performance period that are processed no later than 60 days following the close of the performance period. We received many comments on our comment solicitation to expand the scope of practices that can utilize the Web Interface and will take them into consideration for future rulemaking.
We previously finalized data submission deadlines in the CY 2017 Quality Payment Program final rule (81 FR 77095 through 77097) at § 414.1325(f), which outlined data submission deadlines for all submission mechanisms for individual eligible clinicians and groups for all performance categories. As discussed in section III.I.3.h.(1) of this final rule, the term submission mechanism, that includes submission via the qualified registry, QCDR, EHR, Medicare Part B claims, the CMS Web Interface and attestation, does not align with the existing process of data submission to the Quality Payment Program. In the CY 2019 PFS proposed rule (83 FR 35896), we proposed to revise regulatory text language at § 414.1325(f), which, as noted, we proposed to redesignate as § 414.1325(e), to outline data submission deadlines for all submission types for individual eligible clinicians and groups for all performance categories. In the CY 2019 PFS proposed rule (83 FR 35896), we also proposed to revise § 414.1325(e)(1) to allow flexibility for CMS to alter submission deadlines for the direct, login and upload, the CMS Web Interface, and login and attest submission types. We anticipate that in scenarios where the March 31st deadline falls on a weekend or holiday, we will extend the submission period to the next business day (that is, Monday). There also may be instances where due to unforeseen technical issues, the submission system may be inaccessible for a period of time. If this scenario were to occur, we anticipate that we will extend the submission period to account for this lost time, to the extent feasible. We note that this revision would also revise the previously finalized policy at § 414.1325(e)(3) stating that data must be submitted during an 8-week period following the close of the performance period, and that the period must begin no earlier than January 2 and end no later than March 31 for the CMS Web Interface. In the CY 2019 PFS proposed rule (83 FR 35896), we proposed to align the deadline for the CMS Web Interface submission type with all other submission type deadlines at § 414.1325(e)(1), while we also proposed to remove the previously finalized policy at § 414.1325(e)(3) because it is no longer needed to mandate a different submission
The following is a summary of the comments we received on “Submission Deadlines”.
After consideration of the public comments received, we are finalizing our proposal to redesignate § 414.1325(f) as § 414.1325(e), to outline data submission deadlines for all submission types for individual eligible clinicians and groups for all performance categories. We are finalizing our proposal to revise § 414.1325(e)(1) to allow flexibility for CMS to alter submission deadlines for the direct, login and upload, the CMS Web Interface, and login and attest submission types. We are also finalizing our proposals to align the deadline for the CMS Web Interface submission type with all other submission type deadlines at § 414.1325(e)(1), and to remove the previously finalized policy at § 414.1325(e)(3) because it is no longer needed to mandate a different submission deadline for the CMS Web Interface submission type.
We refer readers to §§ 414.1330 through 414.1340 and the CY 2018 Quality Payment Program final rule (82 FR 53626 through 53641) for our previously established policies regarding the quality performance category.
As discussed in the CY 2019 PFS proposed rule (83 FR 35896), under § 414.1330(a), for purposes of assessing performance of MIPS eligible clinicians on the quality performance category, we will use: Quality measures included in the MIPS final list of quality measures; and quality measures used by QCDRs. We proposed to amend § 414.1330(a) to account for facility-based measurement and the APM scoring standard. For that reason, we proposed at § 414.1330(a) to specify, for a MIPS payment year, that we use the following quality measures, as applicable to assess performance in the quality performance category: Measures included in the MIPS final list of quality measures established by CMS through rulemaking; QCDR measures approved by CMS under § 414.1440; facility-based measures as described under § 414.1380; and MIPS APM measures as described at § 414.1370.
We did not receive any comments on the proposal of how we will assess performance in the quality performance category. Therefore, we are finalizing our proposal to amend § 414.1330(a) to state that for a MIPS payment year, we use the following quality measures, as applicable, to assess performance in the quality performance category: Measures included in the MIPS final list of quality measures established by CMS through rulemaking; QCDR measures approved by CMS under § 414.1440; facility-based measures as described in § 414.1380; and MIPS APM measures as described in § 414.1370.
In the CY 2019 PFS proposed rule (83 FR 35896) under § 414.1330(b)(2) and (3), we state that performance in the quality performance category will comprise 50 percent of a MIPS eligible clinician's final score for the 2020 MIPS payment year and 30 percent of a MIPS eligible clinician's final score for each MIPS payment year thereafter. Section 1848(q)(5)(E)(i)(I) of the Act, as amended by section 51003(a)(1)(C)(i) of the Bipartisan Budget Act of 2018, provides that 30 percent of the final score shall be based on performance with respect to the quality performance category, but that for each of the 1st through 5th years for which MIPS applies to payments, the quality performance category performance percentage shall be increased so that the total percentage points of the increase equals the total number of percentage points that is based on the cost performance category performance is less than 30 percent for the respective year. As discussed in section III.I.3.i.(c) of this final rule, we proposed to weight the cost performance category at 15 percent for the 2021 MIPS payment year. Accordingly, we proposed to amend § 414.1330(b)(2) to provide that performance in the quality performance category will comprise 50 percent of a MIPS eligible clinician's final score for the 2020 MIPS payment year, and proposed at § 414.1330(b)(3) that the quality performance category comprises 45 percent of a MIPS eligible clinician's final score for the 2021 MIPS payment year.
We received the following comments on our proposals regarding the quality performance category's contribution to the final score proposal:
As discussed in section III.I.3.h.(3) of this final rule, we are finalizing our proposal to weight the cost performance category at 15 percent for the 2021 MIPS payment year. After consideration of the public comments received, we are finalizing our proposal to amend § 414.1330(b)(2) to provide that performance in the quality performance category comprises 50 percent of a MIPS eligible clinician's final score for the 2020 MIPS payment year, and our proposal to amend § 414.1330(b)(3) to provide that the quality performance category comprises 45 percent of a MIPS eligible clinician's final score for the 2021 MIPS payment year.
In the CY 2019 Quality Payment Program proposed rule (83 FR 35896 through 35897), we referred readers to § 414.1335(a)(1) for our previously established submission criteria for quality measures submitted via claims, registry, QCDR, or EHR. As discussed in section III.I.3.h. of this final rule, we proposed revisions to existing and additional terminology to clarify the data submission processes available for MIPS eligible clinicians, groups and third party intermediaries, to align with the way users actually submit data to the Quality Payment Program. For that reason, we proposed to revise § 414.1335(a)(1) to state that data would be collected for the following collection types: Medicare Part B claims measures; MIPS CQMs; eCQMs; or QCDR measures. Codified at § 414.1335(a)(1)(i), MIPS eligible clinicians and groups must submit data on at least six measures including at least one outcome measure. If an applicable outcome measure is not available, eligible clinicians and groups must report one other high priority measure. If fewer than six measures apply to the MIPS eligible clinician or group, they must report on each measure that is applicable. Furthermore, we proposed beginning with the 2021 MIPS payment year to revise § 414.1335(a)(1)(ii) to indicate that MIPS eligible clinicians and groups that report on a specialty or subspecialty measure set, must submit data on at least six measures within that set, provided the set contain at least six measures. If the set contains fewer than six measures or if fewer than six measures apply to the MIPS eligible clinician or group, they must report on each measure that is applicable.
As previously expressed in the 2017 Quality Payment Program final rule (81 FR 77090), we want to move away from claims reporting, since approximately 69 percent of the Medicare Part B claims measures are topped out. As discussed in section III.I.3.h. of this final rule, we proposed to limit the Medicare Part B claims submission type, and therefore, the Medicare Part B claims measures, to MIPS eligible clinicians in small practices. We refer readers to section III.I.3.h of this final rule for discussion of this proposal.
The following is a summary of the public comments on these proposals and our responses:
After consideration of the public comments received, we are finalizing our proposal to amend § 414.1335(a)(1) to state that data would be collected for the following collection types: Medicare Part B claims measures; MIPS CQMs; eCQMs; or QCDR measures. Codified at § 414.1335(a)(1)(i), MIPS eligible clinicians and groups must submit data on at least six measures including at least one outcome measure. If an applicable outcome measure is not available, they must report one other high priority measure. If fewer than six measures apply to the MIPS eligible clinician or group, report on each measure that is applicable. We are also finalizing our proposal to amend § 414.1335(a)(1)(ii) to state that MIPS eligible clinicians and groups that report on a specialty or subspecialty measure set, must submit data on at least six measures within that set, provided the set contains at least six measures. If the set contains fewer than six measures or if fewer than six measures apply to the MIPS eligible clinician or group, they must report on each measure that is applicable.
As noted in the CY 2019 PFS proposed rule (83 FR 35897), we did not propose any changes to the established submission criteria for CMS Web Interface measures. For purposes of clarity and organization, we are finalizing a technical change by moving the regulation text on the sampling requirements for reporting CMS Web Interface measures from § 414.1335(a)(2) to § 414.1340(c)(1). However, beginning with the 2021 MIPS payment year, we proposed to revise the terminology with which CMS Web Interface measures are referenced-to align with the updated submission terminology as discussed in section III.I.3.h. of this final rule. Therefore, we proposed to revise § 414.1335(a)(2) from “via the CMS Web Interface-for groups consisting of 25 or more eligible clinicians only”, to “for CMS Web Interface measures”.
In order to ensure that the collection of information is valuable to clinicians and worth the cost and burden of collecting information, and address the challenge of fragmented reporting for multiple measures and submission options, we solicited comment on expanding the CMS Web Interface option to groups with 16 or more eligible clinicians. Preliminary analysis has indicated that expanding the CMS Web Interface option to groups of 16 or more eligible clinicians would likely result in many of these new groups not being able to fully satisfy measure case minimums on multiple CMS Web Interface measures. However, we could possibly mitigate this issue if we require smaller groups (with 16-24 eligible clinicians) to report on only a subset of the CMS Web Interface measures, such as the preventive care measures. We solicited stakeholder feedback on the issue of expanding the CMS Web interface to groups of 16 or more, as well as other factors we should consider with such expansion. We received comments from stakeholders regarding expanding the CMS Web Interface option to groups with 16 or more eligible clinicians. We thank commenters for their input and may take this input into consideration in future years.
As discussed in section III.F.1.c. of this final rule, changes proposed and finalized through rulemaking to the CMS Web Interface measures for MIPS would be applicable to ACO quality reporting under the Shared Savings Program. As discussed in Table Group D: Measures with Substantive Changes Proposed for the 2021 MIPS Payment Year and Future Years of the measures appendix of this final rule, we proposed to remove 6 measures from the CMS Web Interface in MIPS. If finalized, groups reporting CMS Web Interface measures for MIPS would not be responsible for reporting those removed measures. We refer readers to the quality measure appendix for additional details on the proposals related to changes in CMS Web Interface measures.
As discussed in the CY 2017 Quality Payment Program final rule (81 FR 77116), the CMS Web Interface has a two-step attribution process that associates beneficiaries with TINs during the period in which performance is assessed (adopted from the Physician Value-based Payment Modifier (VM) program). The CAHPS for MIPS survey utilizes the same two-step attribution process as the CMS Web Interface. The CY 2017 Quality Payment Program final rule (81 FR 77116) noted that attribution would be conducted using the different identifiers in MIPS. For purposes of the CMS Web Interface and the CAHPS for MIPS survey, we clarified that attribution would be conducted at the TIN level (83 FR 35897).
We did not receive comments on the proposal to revise § 414.1335(a)(2) from “via the CMS Web Interface-for groups consisting of 25 or more eligible clinicians only”, to “for CMS Web Interface measures”.
We are finalizing revisions to § 414.1335(a)(2) to state that via the CMS Web Interface measures- for groups consisting of 25 or more eligible clinicians only, groups must report on all measure included in the CMS Web Interface. The group must report on the first 248 consecutively ranked beneficiaries in the sample for each module.
As noted in the CY 2019 PFS proposed rule (83 FR 35897), we did not propose any changes to the established submission criteria for the CAHPS for MIPS Survey at § 414.1335(a)(3). However, beginning with the 2021 MIPS payment year, we proposed to revise § 414.1335(a)(3) to clarify for the CAHPS for MIPS survey, for the 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 the applicable performance period to transmit survey measure data to us.
We did not receive comments on the proposal to clarify the requirement to use a CMS approved CAHPS for MIPS survey vendor.
We are finalizing our proposal to amend § 414.1335(a)(3) to clarify for the CAHPS for MIPS survey that beginning with the 2021 MIPS payment year, for the 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 the applicable performance period to transmit survey measure data to us.
In the CY 2019 PFS proposed rule (83 FR 35897), we did not propose any changes to the quality data submission criteria for the 2021 MIPS payment year; however, as discussed in section III.I.3.h. of this final rule, we proposed changes to existing and additional submission related terminology. Similarly, although we did not propose changes to the data completeness criteria at § 414.1340, we proposed changes to existing and additional submission related terminology. For that reason, we proposed to revise § 414.1340 to specify that MIPS eligible clinicians and groups submitting quality measures data on QCDR measures, MIPS CQMs, or eCQMs 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 2021; MIPS eligible clinicians and groups submitting quality measure data
We received comments on the proposal to revise § 414.1340 to specify that MIPS eligible clinicians and groups submitting quality measures data 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 2021:
After consideration of the public comments received, we are finalizing revisions to § 414.1340 to specify that MIPS eligible clinicians and groups submitting quality measures data on QCDR measures, MIPS CQMs, or the eCQMs 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 2021; MIPS eligible clinicians and groups submitting quality measure data on the Medicare Part B claims measures 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 the 2021 MIPS payment year; and groups submitting quality measures data on CMS Web Interface measures or the CAHPS for MIPS survey measure, must meet the data submission requirement on the sample of the Medicare Part B patients CMS provides, as applicable.
Under section 1848(q)(2)(C)(ii) of the Act, the Secretary may use measures 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 III.I.3.i.(1)(d) of this final rule for a full discussion of facility-based measures and scoring for the 2021 MIPS payment year.
In the CY 2019 PFS proposed rule (83 FR 35898 through 35899), we noted that developed and announced our Meaningful Measures Initiative.
Furthermore, under § 414.1305, a high priority measure is defined as an outcome, appropriate use, patient safety, efficiency, patient experience or care coordination quality measure. Due to the immense impact of the opioid epidemic across the United States, we believe it is imperative to promote the measurement of opioid use and overuse, risks, monitoring, and education through quality reporting. For that reason, beginning with the 2019 performance period, we proposed at § 414.1305 to amend the definition of a high priority measure to include quality measures that relate to opioids and to further clarify the types of outcome measures that are considered high priority. Beginning with the 2021 MIPS payment year, we proposed to define at § 414.1305 a high priority measure to mean an outcome, appropriate use, patient safety, efficiency, patient experience, care coordination, or
Previously finalized MIPS quality measures can be found in the CY 2018 Quality Payment Program final rule (82 FR 53966 through 54174) and in the CY 2017 Quality Payment Program final rule (81 FR 77558 through 77816). The new MIPS quality measures finalized for inclusion in MIPS for the 2019 performance period and future years are found in Table Group A of the “Appendix 1: Finalized MIPS Quality Measures” of this final rule. The current specialty measure sets can be found in the CY 2018 Quality Payment Program final rule (82 FR 53976 through 54146). The finalized new and modified quality measure specialty sets can be found in Table Group B of the “Appendix 1: Finalized MIPS Quality Measures” of this final rule and include new measures, previously finalized measures with modifications, and previously finalized measures with no modifications.
We note that modifications made to the specialty sets may include the removal of certain previously finalized quality measures. Certain MIPS specialty sets have further defined subspecialty sets, each of which constitutes 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. Please note that the finalized specialty and subspecialty sets are not inclusive of every specialty or subspecialty.
On January 9, 2018,
In the CY 2017 Quality Payment Program final rule (81 FR 77137), we finalized that substantive changes to MIPS quality measures, to include but are not limited to, measures that have had measure specification changes, measure title changes, or domain changes. MIPS quality measures with finalized substantive changes can be found in Table Group D of the “Appendix 1: Finalized MIPS Quality Measures” of this final rule.
As referenced in the CY 2017 Quality Payment Program final rule (81 FR 77291), with regards to eCQMs, in the 2015 EHR Incentive Program final rule, CMS required eligible clinicians, eligible hospitals, and critical access hospitals (CAHs) to use the most recent version of an eCQM for electronic reporting beginning in 2017 (80 FR 62893). We proposed this policy for the end-to-end electronic reporting bonus under MIPS and encourage MIPS eligible clinicians to work with their EHR vendors to ensure they have the most recent version of the eCQM. We will not accept an older version of an eCQM as a submission for the MIPS program for the quality performance category or the end-to-end electronic reporting bonus within that category. MIPS eligible clinicians and groups reporting on the quality performance category are required to use the most recent version of the eCQM specifications. The annual updates to the eCQM specifications and any applicable addenda are available on the electronic quality improvement (eCQI) Resource Center website at
In MIPS, there are a limited number of CMS Web Interface measures. We solicited comment on building upon the CMS Web Interface submission type by expanding the core set of measures available for that submission type to include other specialty specific measures (such as surgery). We thank stakeholders for their comments, and will consider it for future rulemaking.
To provide clinicians with a more cohesive reporting experience, where they may focus on activities and measures that are meaningful to their scope of practice, we discuss the development of public health priority measurement sets that would include measures and activities across the quality, Promoting Interoperability, and improvement activities performance categories, focused on public health priorities such as fighting the opioid epidemic, in section III.I.3.h.(5), of this final rule. We refer readers to section III.I.3.h.(5) of this final rule for additional details on this concept.
We received comments on the proposal to revise the definition of a high priority measure, to include quality measures that relate to opioids and to further clarify the types of outcome measures that are considered high priority; and the policy that MIPS eligible clinicians must use the most recent specification of MIPS eCQMs while reporting for MIPS:
After consideration of the public comments received, we are finalizing our proposal, beginning with the 2021 MIPS payment year, to define a high priority measure at § 414.1305 as an outcome, appropriate use, patient safety, efficiency, patient experience, care coordination, or opioid-related quality measure. Outcome measures include intermediate-outcome and patient-reported outcome measures.
In the CY 2017 Quality Payment Program final rule (81 FR 77090), we indicated that we intend to reduce the number of claims-based measures in future program years as more measures become available through electronic collection types such as eCQMs or MIPS CQMs. In section III.I.3.h of this final rule, we are finalizing our proposal to limit the Medicare Part B claims collection type to small practices, which furthers our goal of moving away from Medicare Part B claims measures. We strongly encourage measure stewards to keep this in mind as they develop and submit measures for consideration, during the call for measures process (specifically for the MIPS quality performance category).
In the CY 2018 Quality Payment Program final rule (82 FR 53637 through 53640), we finalized the 4-year timeline to identify topped out measures, after which we may propose to remove the measures through future rulemaking. After a measure has been identified as topped out for 3 consecutive years through the benchmarks, we may propose to remove the measure through notice and comment rulemaking. 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. We refer readers to the 2018 MIPS Quality Benchmarks' file, that is located on the Quality Payment Program resource library (
In the CY 2019 PFS proposed rule (83 FR 35899 through 35900), we proposed that once a measure has reached an extremely topped out status (for example, a measure with an average mean performance within the 98th to 100th percentile range), we may propose the measure for removal in the next rulemaking cycle, regardless of whether or not it is in the midst of the topped out measure lifecycle, due to the extremely high and unvarying performance where meaningful distinctions and improvement in performance can no longer be made, after taking into account any other relevant factors. We are concerned that topped out non-high priority process measures require data collection burden without added value for eligible clinicians and groups participating in MIPS. It is important to remove these types of measures, so that available measures provide meaningful value to
Since QCDR measures are not approved or removed from MIPS through the rulemaking timeline or cycle, we proposed to exclude QCDR measures from the topped out timeline that was finalized in the CY 2018 Quality Payment Program final rule (82 FR 53640). When a QCDR measure reaches topped out status, as determined during the QCDR measure approval process, it may not be approved as a QCDR measure for the applicable performance period. Because QCDRs have more flexibility to develop innovative measures, we believe there is limited value in maintaining topped out QCDR measures in MIPS.
We received comments on the following proposals: (1) Once a measure has reached an extremely topped out status (for example, a measure with an average mean performance within the 98th to 100th percentile range), we may propose the measure for removal in the next rulemaking cycle, regardless of whether or not it is in the midst of the topped out measure lifecycle; and (2) to exclude QCDR measures from the topped out timeline that was finalized in the CY 2018 Quality Payment Program final rule:
After consideration of the public comments received, we are finalizing our proposal that once the measure has reached an extremely topped out status (for example, a measure with an average mean performance within the 98th to 100th percentile range), we may propose the measure for removal in the next rulemaking cycle, regardless of whether or not it is in the midst of the topped out measure lifecycle, due to the extremely high and unvarying performance where meaningful distinctions and improvement in performance can no longer be made, after taking into account any other relevant factors. However, we will also consider retaining the measure if there are compelling reasons as to why it should not be removed (for example, if the removal would impact the number of measures available to a specialist type or if the measure addressed an area of importance to CMS).
We are also finalizing our proposal to exclude QCDR measures from the topped out timeline that was finalized in the CY 2018 Quality Payment Program final rule (82 FR 53640). When a QCDR measure reaches topped out status, as determined during the QCDR measure approval process, it may not be approved as a QCDR measure for the applicable performance period.
In the CY 2017 Quality Payment Program final rule (81 FR 77136 through 77137), we discussed removal criteria for quality measures, including that a quality measure may be considered for removal if the Secretary determines that the measure is no longer meaningful, such as measures that are topped out. Furthermore, if a measure steward is no longer able to maintain the quality measure, it would also be considered for removal.
We have previously communicated to stakeholders our desire to reduce the number of process measures within the MIPS quality measure set. In the CY 2017 Quality Payment Program final rule (81 FR 77101), we explained that we believe that outcome measures are more valuable than clinical process measures and are instrumental to improving the quality of care patients receive. In the CY 2018 Quality Payment Program quality measure set, 102 of the 275 quality measures are process measures that are not considered high priority. As discussed above, beginning with the 2021 MIPS payment year, we proposed to define at § 414.1305 a high priority measure to mean an outcome, appropriate use, patient safety, efficiency, patient experience, care coordination, or opioid-related quality measure. Because the removal of all non-high priority process measures would impact most specialty sets, nearly 94 percent, we believe incrementally removing non-high priority process measures through notice and comment rulemaking is appropriate.
As described in the CY 2019 PFS proposed rule (83 FR 35900), beginning with the 2019 performance period, we proposed to implement an approach to incrementally remove process measures where prior to removal, consideration will be given to, but is not limited to:
• Whether the removal of the process measure impacts the number of measures available for a specific specialty.
• Whether the measure addresses a priority area highlighted in the Measure Development Plan at
• Whether the measure promotes positive outcomes in patients.
• Considerations and evaluation of the measure's performance data.
• Whether the measure is designated as high priority or not.
• Whether the measure has reached an extremely topped out status within the 98th to 100th percentile range, due to the extremely high and unvarying performance where meaningful distinctions and improvement in performance can no longer be made, as described in section III.I.3.(b)(ii) of this final rule.
We received the following comments on the proposal to implement a process to incrementally remove process measures:
After consideration of the public comments received, we are finalizing our proposal, beginning with the 2021 MIPS payment year, to implement an approach to incrementally remove process measures where prior to removal, consideration will be given to, but will not be limited to:
• Whether the removal of the process measure impacts the number of measures available for a specific specialty.
• Whether the measure addresses a priority area highlighted in the Measure Development Plan:
• Whether the measure promotes positive outcomes in patients.
• Considerations and evaluation of the measure's performance data.
• Whether the measure is designated as high priority or not.
• Whether the measure has reached an extremely topped out status within the 98th to 100th percentile range, due to the extremely high and unvarying performance where meaningful distinctions and improvement in performance can no longer be made.
In the CY 2019 PFS proposed rule (83 FR 35900), we outlined the various types of MIPS quality and QCDR measures available for reporting in the quality performance category, such as outcome, high-priority, composite, and process measures, we acknowledge that not all measures are created equal. For example, the value or information gained by reporting on certain process measures does not equate that which is collected on outcome measures. We seek to ensure that the collection and submission of data is valuable to clinicians and worth the cost and burden of collecting the information.
Based on this, we solicited comment on implementing a system where measures are classified as a particular value (gold, silver or bronze) and points are awarded based on the value of the measure. For example, higher value measures that are considered “gold” standard, which could include outcome measures, composite measures, or measures that address agency priorities (such as opioids). The CAHPS for MIPS survey, which collects patient experience data, may also be considered a high value measure. Measures that are considered second tier, or at a “silver” standard would be measures that are considered process measures that are directly related to outcomes and have a good gap in performance (there is no high, unwavering performance) and demonstrate room for improvement; or topped out outcome measures. Lower value measures, such as standard of care process measures or topped out process measures would be considered “bronze” measures. We refer readers to section III.I.3.i.(1)(b)(xi) of this final rule for discussion on the assignment of value and scoring based on measure value.
We have received comments from stakeholders regarding categorizing measure by value. We thank commenters for their input and may take this input into consideration in future years.
For a description of the statutory basis and our existing policies for the cost performance category, we refer readers to the CY 2017 and CY 2018 Quality Payment Program final rules (81 FR 77162 through 77177, and 82 FR 53641 through 53648, respectively).
In the CY 2018 Quality Payment Program final rule, we established that the weight of the cost performance category would be 10 percent of the final score for the 2020 MIPS payment year (82 FR 53643). We had previously finalized in the CY 2017 Quality Payment Program final rule at § 414.1350(b)(3) that beginning with the 2021 MIPS payment year, the cost performance category would be 30 percent of the final score, as required by section 1848(q)(5)(E)(i)(II)(aa) of the Act (81 FR 77166). Section 51003(a)(1)(C) of the Bipartisan Budget Act of 2018, enacted on February 9, 2018, amended section 1848(q)(5)(E)(i)(II)(bb) of the Act such that for each of the second, third, fourth, and fifth years for which the MIPS applies to payments, not less than 10 percent and not more than 30 percent of the MIPS final score shall be based on the cost performance category score. Additionally, this provision shall not be construed as preventing the Secretary from adopting a 30 percent weight if the Secretary determines, based on information posted under section 1848(r)(2)(I) of the Act, that sufficient cost measures are ready for adoption for use under the cost performance category for the relevant performance period. Section 51003(a)(2) of the Bipartisan Budget Act of 2018 amended section 1848(r)(2) of the Act to add a new paragraph (I), which we discuss in section III.I.3.h.(3)(b)(i) of this final rule.
In light of these amendments, in the proposed rule (83 FR 35900 through 35901), we proposed at § 414.1350(d)(3) that the cost performance category would make up 15 percent of a MIPS eligible clinician's final score for the 2021 MIPS payment year. As discussed in section III.I.3.h.(3)(b)(iv) of this final rule, § 414.1350(b) will be redesignated as § 414.1350(d). We proposed to delete the existing text under § 414.1350(b)(3) and address the weight of the cost performance category for the MIPS payment years following 2021 in future rulemaking. We also proposed a technical change to the text at § 414.1350(b) (redesignated as § 414.1350(d)) to state that the cost performance category weight will be as specified under redesignated § 414.1350(d), unless a different scoring weight is assigned by CMS under section 1848(q)(5)(F) of the Act (83 FR 35901).
We believe that measuring cost is an integral part of measuring value, and we believe that clinicians have a significant impact on the costs of patient care. However, we proposed to only modestly increase the weight of the cost performance category for the 2021 MIPS payment year from the 2020 MIPS payment year because we recognize that cost measures are still relatively early in the process of development and that clinicians do not have the level of familiarity or understanding of cost measures that they do of comparable quality measures (83 FR 35900 through 35901). As described in section III.I.3.h.(3)(b)(ii) of this final rule, we are finalizing the addition of 8 episode-based measures to the cost performance category beginning with the 2019 MIPS performance period. This is a first step in developing a more robust and clinician-focused measurement of cost performance. We will continue to work on developing additional episode-based measures that we may consider proposing for the cost performance category in future years. Introducing more measures over time would allow for more clinicians to be measured in this performance category. It would also allow time for more outreach to clinicians to better educate them on the cost measures. We considered maintaining the weight of the cost performance category at 10 percent for the 2021 MIPS payment year as we recognize that clinicians are still learning about the cost performance category and being introduced to new measures. We invited comment on
The following is a summary of the public comments received on these proposals and our responses:
Additionally, several commenters opposed our proposal to increase the weight of the cost performance category because we proposed to add new episode-based measures (as detailed in section III.I.3.h.(3)(b)(ii) of this rule) and clinicians should have time to learn about these measures before the category weight is increased. Additionally, several commenters suggested CMS wait to increase the cost performance category weight until sufficient episode groups exist for additional specialties.
In regards to the episode-based measures, we do not believe the introduction of these new measures should mean that the weight of the performance category should be maintained, especially since stakeholders had the opportunity to gain experience with the new measures through field testing in the fall of 2017. The performance category also still includes two measures that were used in the first 2 years of MIPS. The Bipartisan Budget Act of 2018 gave CMS increased flexibility to establish the weight of the cost performance category for the first 5 years of MIPS, but the weight is still required to be 30 percent beginning with the 2024 MIPS payment year. Therefore, we believe it is necessary to begin adjusting the weight gradually, including increasing the weight to 15 percent for the 2021 MIPS payment year. We will concurrently look to increase the number of clinicians who are measured in the cost performance category by developing and considering for inclusion in the Quality Payment Program more episode-based measures that cover additional types of clinicians and specialties.
After consideration of the public comments, we are finalizing our proposal at § 414.1350(d)(3) to weight the cost performance category at 15 percent for the 2021 MIPS payment year as proposed. Additionally, we are also finalizing our proposal to delete the existing text under § 414.1350(b)(3) and address the weight of the cost performance category for the MIPS payment years following 2021 in future rulemaking as proposed. Finally, we are finalizing our proposed technical change to the text at § 414.1350(b) (redesignated as § 414.1350(d)) to state that the cost performance category weight will be as specified under redesignated § 414.1350(d), unless a different scoring weight is assigned by CMS under section 1848(q)(5)(F) of the Act, as proposed.
In accordance with section 1848(q)(5)(E)(i)(II)(bb) of the Act, we will continue to evaluate whether sufficient cost measures are ready for adoption under the cost performance category and move towards the goal of increasing the weight to 30 percent of the final score. To provide for a smooth transition, we anticipate that we would increase the weight of the cost performance category by 5 percentage points each year until we reach the required 30 percent weight for the 2024 MIPS payment year. We invited comments on this approach to weighting the cost performance category for the 2022 and 2023 MIPS payment years, considering our flexibility in setting the weight between 10 percent and 30 percent of the final score, the availability of cost measures, and our desire to ensure a smooth transition to a 30 percent weight for the cost performance category. We appreciate the comments we received and will consider them as we develop proposals for future rulemaking.
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. In the CY 2018 Quality Payment Program final rule, we established two cost measures (total per capita cost measure and Medicare spending per beneficiary (MSPB) measure) for the 2018 MIPS performance period and future performance periods (82 FR 53644). These measures were previously established for the 2017 MIPS performance period (81 FR 77168). 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 through rulemaking as measure development continues. In general, we expect to evaluate cost measures according to the measure reevaluation and maintenance processes outlined in the “Blueprint for the CMS Measures Management System” (
We will also continue to update the specifications to address changes in coding, risk adjustment, and other factors. The process for updating measure specifications will take place through ongoing maintenance and evaluation, during which we expect to continue seeking stakeholder input. As we noted above, any substantive changes to a measure would be proposed for adoption in future years through notice and comment rulemaking. We appreciate the feedback that we have received so far throughout the measure development process and believe that stakeholders will continue to provide feedback to the measure development contractor on episode-based cost measures by submitting written comments during public comment opportunities, by participating in the clinical subcommittees convened by the measure development contractor, or by attending education and outreach events. We will take all comments and feedback into consideration as part of the ongoing measure evaluation process.
As we noted in the CY 2017 Quality Payment Program final rule (81 FR 77137) regarding quality measures, which we believe would also apply for cost measures, some updates may incorporate changes that would not substantively change the intent of the measure. Examples of such changes may include updated diagnosis or procedure codes or changes to exclusions to the patient population or definitions. While we address such changes on a case-by-case basis, we generally believe these types of maintenance changes are distinct from substantive changes to measures that result in what are considered new or different measures. As described in section 3 of the Blueprint for the CMS Measures Management System Version 14.0, if substantive changes to these measures become necessary, we expect to follow the pre-rulemaking process for new measures, including resubmission to the Measures Under Consideration (MUC) list and consideration by the Measure Applications Partnership (MAP). The MAP provides an additional opportunity for an interdisciplinary group of stakeholders to provide feedback on whether they believe the measures under consideration are attributable and applicable to clinicians. The MAP also reviews measures for clinician level feasibility, reliability, and validity. They also consider whether the measures are scientifically acceptable and reflect current clinical guidelines.
Section 51003(a)(2) of the Bipartisan Budget Act of 2018 amended section 1848(r)(2) of the Act to add a new paragraph (I) requiring the Secretary to post on the CMS website information on cost measures in use under MIPS, cost measures under development and the time-frame for such development, potential future cost measure topics, a description of stakeholder engagement, and the percent of expenditures under Medicare Part A and Part B that are covered by cost measures. This information shall be posted no later than December 31 of each year beginning with 2018. We expect this posting will provide a list of the cost measures established for the cost performance category for the current performance period (for example, the posting in 2018 would include a list of the measures for the 2018 MIPS performance period), as well as a list of any cost measures that may be proposed for a future performance period through rulemaking. We will provide hyperlinks to the measure specifications documents and include the percent of Medicare Part A and Part B expenditures that are covered by these cost measures. The posting will also include a list and description of the measures under development at that time. We intend to summarize the timeline for measure development, including the stakeholder engagement activities undertaken, which may include a TEP, clinical subcommittees, field testing, and education and outreach activities, such as national provider calls and listening sessions. Finally, the posting will provide an overview of potential future topics in cost measure development, such as any clinical areas in which measures may be developed in the future (83 FR 35901 through 35902).
Episode-based measures differ from the total per capita cost measure and MSPB measure because episode-based measure specifications only include items and 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 timeframe.
We discussed our progress in the development of episode-based measures in the CY 2018 Quality Payment Program proposed rule (82 FR 30049 through 30050) and received significant positive feedback on the process used to develop the measures as well as the measures' clinical focus that was informed by expert opinion (82 FR 53644 through 53646). The specific measures selected for the initial round of field testing were included based on the volume of beneficiaries impacted by the condition or procedure, the share of cost to Medicare impacted by the condition or procedure, the number of clinicians/clinician groups attributed, and the potential for alignment with existing quality measures.
We have developed episode-based measures to represent the cost to Medicare for the items and services furnished to a patient during an episode of care (“episode”). Episode-based measures are developed to let attributed clinicians know the cost of the care clinically related to their initial treatment of a patient and provided during the episode's timeframe. Specifically, we define cost based on the allowed amounts on Medicare claims, which include both Medicare payments and beneficiary deductible and coinsurance amounts. Episode-based measures are calculated using Medicare Parts A and B fee-for-service claims data and are based on episode groups. Episode groups:
• Represent a clinically cohesive set of medical services rendered to treat a given medical condition.
• Aggregate all items and services provided for a defined patient cohort to assess the total cost of care.
• Are defined around treatment for a condition (acute or chronic) or performance of a procedure.
Items and services in the episode group could be treatment services, diagnostic services, and ancillary items and services directly related to treatment (such as anesthesia for a surgical procedure). They could also be items and services that occur after the initial treatment period that may be furnished to patients as follow-up care or to treat complications resulting from the treatment. An episode is a specific instance of an episode group for a specific patient and clinician. For example, in a given year, a clinician might be attributed 20 episodes (instances of the episode group) from the episode group for heart failure. In section III.I.3.h.(3)(b)(iv) of this final rule, we discuss the attribution rules for cost measures.
After episodes are attributed to one or more clinicians, items and services may be included in the episode costs if they are furnished within a patient's episode window. Items and services will be included if they are the trigger event for the episode or if a service assignment rule identifies them as a clinically related item or service during the episode. The detailed specifications for these measures, which include information about the service assignment rules, can be reviewed at
To ensure a more accurate comparison of cost across clinicians, episode costs are payment standardized and risk adjusted. Payment standardization adjusts the allowed amount for an item or service to facilitate cost comparisons and limit observed differences in costs to those that may result from health care delivery choices. Payment standardized costs remove any Medicare payment differences due to adjustments for geographic differences in wage levels or policy-driven payment adjustments such as those for teaching hospitals. Risk adjustment accounts for patient characteristics that can influence spending and are outside of clinician control. For example, for the elective outpatient PCI episode-based measure, the risk adjustment model may account for a patient's history of heart failure.
The measure development contractor has continued to seek extensive stakeholder feedback on the development of episode-based measures, building on the processes outlined in the CY 2018 Quality Payment Program final rule (82 FR 53644). These processes included convening a TEP and clinical subcommittees to solicit expert and clinical input for measure development, conducting national field testing on the episode-based cost measures developed, and seeking input from clinicians and stakeholders through engagement activities. Seven clinical subcommittees were convened through an open call for nominations between March 17, 2017 and April 24, 2017, composed of nearly 150 clinicians affiliated with almost 100 specialty societies. These subcommittees met at an in-person meeting and through webinars from May 2017 to January 2018 to select an episode group or groups to develop and provide detailed clinical input on each component of episode-based cost measures. These components included episode triggers and windows, item and service assignment, exclusions, attribution methodology, and risk adjustment variables.
As described in the CY 2018 Quality Payment Program final rule (82 FR 53645), we provided an initial opportunity for clinicians to review their performance based on the new episode-based measures developed by the clinical subcommittees in the fall of 2017 through national field testing.
During field testing, we sought feedback from stakeholders on the draft measure specifications, feedback report format, and supplemental documentation through an online form. We received over 200 responses, including 53 comment letters, during the field test feedback period. We shared the feedback on the draft measure specifications with the clinical subcommittees who considered it in providing input on measure refinements after the end of field testing. A field testing feedback summary report is publicly available at
To engage clinicians and stakeholders, we conducted extensive outreach activities including hosting National Provider Calls (NPCs) to provide information about the measure development process and field test reports, and to give stakeholders the opportunity to ask questions.
The new episode-based measures developed by the clinical subcommittees were considered by the NQF-convened MAP, and were all conditionally supported by the MAP, with the recommendation of obtaining NQF endorsement. We intend to submit these episode-based measures to NQF for endorsement in the future. The MAP provides an opportunity for an interdisciplinary group of stakeholders to provide input on whether the measures under consideration are attributable and applicable to clinicians. The MAP also reviews measures for clinician level feasibility, reliability, and validity. Following the successful field testing and review through the MAP process, we proposed to add 8 episode-based measures listed in Table 36 as cost measures for the 2019 MIPS performance period and future performance periods (83 FR 35902).
The attribution methodology for these measures is discussed in section III.I.3.h.(3)(b)(iv)(B) of this final rule. The detailed specifications for these measures can be reviewed at
The following is a summary of the public comments received on these proposals and our responses:
Our conceptual framework provides a comprehensive foundation for episode-based measures that can be used to incentivize high-value care by attributed clinicians at each stage of the patient care continuum, and allows for progressively adding new episode-based measures in a logically cohesive and consistent manner. The framework involves three distinct types of episode groups: Procedural, acute inpatient medical condition, and chronic. Procedural episode groups are triggered by performance of a major procedure, acute inpatient medical condition episode groups are triggered by evaluation and management claims during hospitalizations with specific DRGs, and chronic condition episode groups are triggered by evaluation and management claims with particular diagnoses. Attribution is determined by the clinician(s) involved in the triggering claims, with consistent rules within each type of episode group. Services, and their associated costs, are assigned to an episode based on a clinical determination of whether a service is under the influence of the attributed clinician (for example, routine follow-up care or adverse health outcomes such as a readmission). Clinical determinations of service assignment are made using common criteria and methods across episode groups, to encourage distinctions in service assignment and reflect differences in clinical influence across episode groups. Risk adjustment employs a common starting point of the CMS-HCC model across episode groups, but risk adjustment models can be enhanced by the use of risk factors specifically adapted for each episode group. This allows, for instance, for adjustments to be made for an acute condition episode group based on whether the condition is a stand-alone presentation of the condition versus the exacerbation of an ongoing chronic condition. The framework also allows for complete stratification in risk adjustment through the use of episode sub-groups, with the definition of sub-groups (such as unilateral vs. bilateral) being based on common principles across episode groups. Episodes from distinct episode groups can overlap with one another to ensure that each clinician treating a patient with multiple health issues has incentives for providing high value care. When a given service is clinically related to only one overlapping episode, it is assigned only to that one. When a service is clinically related to two overlapping episodes, it is assigned to both to ensure joint accountability. Since each episode's cost is compared to a risk-adjusted expected cost only for other episodes from the same episode group, there is no issue of double counting. This approach allows for development of distinct episode groups that cover a patient's care continuum, including an underlying chronic condition as well as a procedure or treatment for an exacerbation. As an example, a patient receiving chronic care for coronary artery disease (CAD) (a chronic episode) could have an acute incidence of STEMI requiring PCI for stabilization (an acute inpatient medical condition episode), and due to having severe CAD could later receive a coronary artery bypass graft (CABG) procedure (a procedural episode). This logically, cohesive framework for episode group development avoids a series of challenges raised by previously studied episode grouping approaches that assign services to only a single episode, including lack of transparency and predictability in what an attributed clinician will be held accountable for at the beginning of an episode. For information on how this framework has been operationalized, refer to the measure specifications available at
Using this conceptual framework, we have created a concrete process for developing new measures over time. To prioritize the areas for development of the new cost measures, our measure development contractor convened a clinical committee, comprised of over 70 clinicians affiliated with over 50 specialty societies that provided input necessary to develop a public posting of 117 episode groups for development in December 2016. We then used criteria vetted by a standing technical expert panel—comprised of 19 clinicians, health researchers, and representatives of patient advocacy organizations—to divide these 117 episode groups into 18 clinical areas. The prioritization criteria focused on identifying areas where potential episode-based measures could affect the highest number of beneficiaries and clinicians, address particularly high cost procedures and conditions, provide an opportunity for improvement, and best align with quality measures.
Our measure development contractor has and is continuing to convene clinical subcommittees for each of the priority clinical areas. The composition of a subcommittee for an area principally consists of practicing clinicians who are candidates for attribution of episode-based measures developed for that area. Each clinical subcommittee prioritizes specific episode measures for development within its area based on the criteria above. The structure for developing specific cost measures relies on a systematic data-based conceptual framework for triggering logic, cohort definition, attribution, and cost assignment. For the 8 episode-based measures discussed in this rule, nearly 150 clinicians affiliated with 98 specialty societies participated in the clinical subcommittees in the creation of these measures. After positive reception of the initial development process, 267 clinicians affiliated with more than 120 specialty societies are now participating in the clinical subcommittees and workgroups developing 11 additional episode-based cost measures. The structure of episode-based cost measure development provides a vehicle for continued stakeholder engagement as additional measures are developed in the future.
The total per capita cost measure uses a primary care attribution method in which a specialist would not be attributed a patient unless that patient did not see a primary care clinician (based on the Medicare specialty) during the year. For some patients who do not see a primary care clinician in a year, a specialist may serve as a primary care clinician due to an underlying disease or condition which the specialist focuses on. For the MSPB measure, we do not believe it is appropriate to limit attribution to primary care clinicians as specialists may perform procedures or manage patients in the hospital and can have a significant influence on the overall spending during the hospitalization.
Both the total per capita cost and MSPB measures are being refined as part of the measure maintenance and re-evaluation process, incorporating substantial stakeholder input. We are completing an extensive outreach initiative in the fall of 2018 to share performance information with clinicians as part of field testing, a part of measure re-evaluation. After considering the stakeholder feedback on these refinements, we may propose the re-evaluated measures for use in MIPS to replace the current versions of the measures in the program.
After consideration of the public comments, we are finalizing our proposal to include the 8 episode-based measures listed in Table 36 in the cost performance category beginning with the 2019 MIPS performance period with a modification to the STEMI with PCI, Elective Outpatient PCI, and Revascularization for Lower Extremity Chronic Critical Limb Ischemia episode-based measures to remove assignments of the MS-DRGs without MI or HF (MS-DRGs 224-225: Defib with Cath without MI/HF and MS-DRGs 226-227: Defib without Cath without MI/HF).
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. We seek to ensure that MIPS eligible clinicians are measured reliably. In the CY 2017 Quality Payment Program final rule, we finalized a case minimum of 20 for the episode-based measures specified for the 2017 MIPS performance period (81 FR 77175). We examined the reliability of the proposed 8 episode-based measures listed in Table 36 at various case minimums and found that all of these measures meet the reliability threshold of 0.4 for the majority of clinicians and groups at a case minimum of 10 episodes for procedural episode-based measures and 20 episodes for acute inpatient medical condition episode-based measures. Furthermore, these case minimums would balance the goal of increased reliability with the goal of adopting cost measures that are applicable to a larger set of clinicians and clinician groups. Our analysis indicated that the case minimum for procedural episode-based measures could be lower than that of acute inpatient medical condition episode-based measures while still ensuring reliable measures.
Table 37 presents the percentage of TINs and TIN/NPIs with 0.4 or higher reliability, as well as the mean reliability for the subset of TINs and TIN/NPIs who met the proposed case minimums of 10 episodes for procedural episode-based measures and 20 episodes for acute inpatient medical condition episode-based measures for each of the proposed episode-based measures. Each row in Table 37 provides the percentage of TINs and TIN/NPIs who had reliability of 0.4 or higher among all the TINs and TIN/NPIs who met the case minimum for that measure during the study period (6/1/2016 to 5/31/2017).
Based on this analysis, we proposed at § 414.1350(c)(4) and (5) a case minimum of 10 episodes for the procedural episode-based measures and 20 episodes for the acute inpatient medical condition episode-based measures beginning with the 2019 MIPS performance period (83 FR 35904). We stated that these case minimums would ensure that the measures meet the reliability threshold for groups and individual clinicians. We stated that we believe that the proposed case minimums for these procedural and acute inpatient medical condition episode-based measures would achieve a balance between several important considerations. In order to help clinicians become familiar with the episode-based measures as a robust and clinician-focused form of cost measurement, we want to provide as many clinicians as possible the opportunity to receive information about their performance on reliable measures. This is consistent with the stakeholder feedback that we have received throughout the measure development process. We stated that we believe that calculating episode-based measures with these case minimums would accurately and reliably measure the performance of a large number of clinicians and clinician group practices.
We stated that we recognize that the percentage of TIN/NPIs with 0.4 or greater reliability for the Simple Pneumonia with Hospitalization measure, while still meeting our reliability threshold, is somewhat lower than that of the other proposed acute inpatient medical condition episode-based measures, as well as all of the proposed procedural episode-based measures. For this reason, we considered an alternative case minimum of 30 for both TIN/NPIs and TINs for this measure. At this case minimum, 100 percent of TIN/NPIs would have 0.4 or greater reliability and the mean reliability would increase to 0.49 for TIN/NPIs and 0.70 for TINs. However, the number of TINs and TIN/NPIs that would meet the case minimum for this important measure would decrease by 29 percent for TINs and by 84 percent for TIN/NPIs. We invited comments on
We previously finalized a case minimum of 35 for the MSPB measure (81 FR 77171), 20 for the total per capita cost measure (81 FR 77170), and 20 for the episode-based measures specified for the 2017 MIPS performance period (81 FR 77175). We proposed to codify these final policies under § 414.1350(c) (83 FR 35904).
In general, higher case minimums increase reliability, but also decrease the number of clinicians who are measured. We aim to measure as many clinicians as possible in the cost performance category. Some clinicians or smaller groups may never see enough patients in a single year to meet the case minimum for a specific episode-based measure. For this reason, we solicited comment on whether we should consider expanding the performance period for the cost performance category measures from a single year to 2 or more years in future rulemaking. We believe this would allow us to more reliably measure a larger number of clinicians. However, we are also concerned that expanding the performance period would increase the time between the measurement of performance and the application of the MIPS payment adjustment. In addition, it would take a longer period of time for us to introduce new cost measures as we would expect to adopt them through rulemaking prior to the beginning of the performance period.
The following is a summary of the public comments received on these proposals and our responses:
After consideration of the public comments, we are finalizing our proposed case minimum of 10 episodes for the procedural episode-based measures and 20 episodes for the acute inpatient medical condition episode-based measures beginning with the 2019 MIPS performance period at § 414.1350(c)(4) and (5) as proposed. We are also finalizing our proposal to codify our previously finalized case minimum of 35 for the MSPB measure, 20 for the total per capita cost measure, and 20 for the episode-based measures specified for the 2017 MIPS performance period at § 414.1350(c) as proposed. We will take the comments we received on expanding the performance period for measures in the cost performance category into account for future rulemaking.
In the CY 2017 Quality Payment Program final rule (81 FR 77168 through 77169; 77174 through 77176), we adopted final policies concerning the attribution methodologies for the total
The following is a summary of the public comments received on these proposals and our responses:
After consideration of the public comments, we are finalizing our proposal to codify the previously adopted final policies at § 414.1350(b) as proposed.
In section III.I.3.h.(3)(b)(ii) of this final rule, we finalized 8 episode-based measures for the cost performance category for the 2019 MIPS performance period and future performance periods, which can be categorized into two types of episode groups: Acute inpatient medical condition episode groups, and procedural episode groups. These measures only include items and 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. The attribution methodology will be the same for all of the measures within each type of episode groups—acute inpatient medical condition episode groups and procedural episode groups. Our approach to attribution will ensure that the episode-based measures reflect the roles of the individuals and groups in providing care to patients.
For acute inpatient medical condition episode groups specified beginning in the 2019 performance period, we proposed at § 414.1350(b)(6) to attribute episodes to each MIPS eligible clinician who bills inpatient evaluation and management (E&M) claim lines during a trigger inpatient hospitalization under a TIN that renders at least 30 percent of the inpatient E&M claim lines in that hospitalization (83 FR 35905). We stated that a trigger inpatient hospitalization is a hospitalization with a particular MS-DRG identifying the episode group. These MS-DRGs, and any supplementary trigger rules, are identified in the measure specifications posted at
This proposed attribution approach differs from the attribution approach previously established for episode-based measures for acute inpatient medical conditions specified for the 2017 performance period in the CY 2017 Quality Payment Program final rule (81 FR 77174 through 77175). The previous approach attributed episodes to TIN/NPIs who individually exceed the 30 percent E&M threshold, while excluding all episodes where no TIN/NPI exceeds the 30 percent threshold. Throughout the measure development process, stakeholders have discussed the team-based nature of acute care, in which multiple clinicians share management of a patient during a hospital stay. The previous approach outlined in the CY 2017 Quality Payment Program final rule (81 FR 77174 through 77175) does not capture patients' episodes when a group collaborates to manage a patient but no individual clinician exceeds the 30 percent threshold. Based upon stakeholder feedback, our proposed approach emphasizes team-based care and expands the measures' coverage of clinicians, patients, and cost.
We provided an example to illustrate the proposed attribution rules for acute inpatient medical condition episode groups in the proposed rule (83 FR 35905).
For procedural episode groups specified beginning in the 2019 MIPS performance period, we proposed at § 414.1350(b)(7) to attribute episodes to each MIPS eligible clinician who renders a trigger service as identified by HCPCS/CPT procedure codes (83 FR 35905). These trigger services are identified in the measure specifications posted at
The following is a summary of the public comments received on these proposals and our responses:
After consideration of the public comments, we are finalizing as proposed our proposal at § 414.1350(b)(6) for acute inpatient medical condition episode groups specified beginning in the 2019 performance period, to attribute episodes to each MIPS eligible clinician who bills inpatient evaluation and management (E&M) claim lines during a trigger inpatient hospitalization under a TIN that renders at least 30 percent of the inpatient E&M claim lines in that hospitalization. Additionally, we also finalizing as proposed our proposal at § 414.1350(b)(7) for procedural episode groups specified beginning in the 2019 MIPS performance period, to attribute episodes to each MIPS eligible clinician who renders a trigger service as identified by HCPCS/CPT procedure codes.
In CY 2017 Quality Payment Program final rule (81 FR 77179 through 77180), we codified at § 414.1355 that the improvement activities performance category would account for 15 percent of the final score. We refer readers to section III.I.3.i.(1)(e) of this final rule where we proposed to modify § 414.1355 to provide further technical clarifications. In addition, in the CY 2018 Quality Payment Program final
In the CY 2017 Quality Payment Program final rule (81 FR 77539), we codified the definition of improvement activities at § 414.1305 to mean 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. Further, in that final rule (81 FR 77190), we codified at § 414.1365 that the improvement activities performance category would include the subcategories of activities provided at section 1848(q)(2)(B)(iii) of the Act. We also codified subcategories for improvement activities at § 414.1365 (81 FR 77190).
We also previously codified in the CY 2017 and CY 2018 Quality Payment Program final rules (81 FR 77180 and 82 FR 53651, respectively) data submission criteria for the improvement activities performance category at § 414.1360(a)(1). In addition, we established exceptions 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 (81 FR 77185, 77188). Specifically, we codified at § 414.1380(b)(3)(vii) that non-patient facing MIPS eligible clinicians and groups, small practices, and practices located in rural areas and geographic HPSAs receive full credit for the improvement activities performance category by selecting one high-weighted improvement activity or two medium-weighted improvement activities; such practices receive half credit for the improvement activities performance category by selecting one medium-weighted improvement activity (81 FR 77185). We refer readers to section III.I.3.i.(1)(e)(i)(B) of this final rule for our proposals related to that provision. In addition, we specified at § 414.1305 that rural areas refers to ZIP codes designated as rural, using the most recent HRSA Area Health Resource File data set available (81 FR 77188, 82 FR 53582). Lastly, we finalized the meaning of Health Professional Shortage Areas (HPSA) at § 414.1305 to mean areas as designated under section 332(a)(1)(A) of the Public Health Service Act (81 FR 77188). In the CY 2018 Quality Payment Program final rule (82 FR 53581), we modified the definition of small practices at § 414.1305 to mean practices consisting of 15 or fewer eligible clinicians.
In the CY 2019 PFS proposed rule (83 FR 35906 through 35912), we requested comments on our proposals to: (1) Revise § 414.1360(a)(1) to more accurately describe the data submission criteria; (2) delete § 414.1365 and move improvement activities subcategories to § 414.1355(c); (3) update the criteria considered for nominating new improvement activities; (4) modify the Annual Call for Activities timeline for the CY 2019 performance period and future years; (5) add 6 new improvement activities for the CY 2019 performance period and future years; (6) modify 5 existing improvement activities for the CY 2019 performance period and future years; and (7) remove 1 existing improvement activity for the CY 2019 performance period and future years. In addition, we also requested comments on our proposals with respect to the CMS Study on Factors Associated with Reporting Quality Measures for the CY 2019 performance period and future years the following proposals: (1) Change the title of the study to CMS Study on Factors Associated with Reporting Quality Measures; (2) increase the sample size to a minimum of 200 participants; (3) limit the focus group requirement to a subset of the 200 participants; and (4) require that at least one of the minimum of three required measures be a high priority measure. We are also making clarifications to: (1) Considerations for selecting improvement activities for the CY 2019 performance period and future years; and (2) the weighting of improvement activities.
These topics are discussed in more detail below.
We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77181) for submission mechanism policies we finalized and codified for the transition year of MIPS. In the CY 2018 Quality Payment Program final rule (82 FR 53651), we continued these policies for future years. Specifically, we finalized that for MIPS Year 2 and future years, MIPS eligible clinicians or groups must submit data on MIPS improvement activities in one of the following manners: Qualified registries; EHR submission mechanisms; QCDR; CMS Web Interface; or attestation. Additionally, we finalized 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 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 finalized that the MIPS eligible clinician or group must certify all improvement activities were performed and the health IT vendor, QCDR, or qualified registry would submit on their behalf (82 FR 53650 through 53651). We also updated § 414.1360 to reflect those changes (82 FR 53651). We refer readers to section III.I.3.h.(1) of this final rule, MIPS Performance Category Measures and Activities, where we discuss our finalized policies to update the data submission process for MIPS eligible clinicians, groups and third party intermediaries, by updating our terminology. We also refer readers to changes to § 414.1325 for data submission requirements. In the CY 2019 PFS proposed rule (83 FR 35906), we proposed those changes to more closely align with the actual submission experience users have.
In alignment with those proposals, we also proposed to revise § 414.1360(a)(1) to more accurately reflect the data submission process for the improvement activities performance category. In particular, in the CY 2019 PFS proposed rule (83 FR 35906), we proposed that instead of “via qualified registries; EHR submission mechanisms; QCDR, CMS Web Interface; or attestation,” as currently stated, we revised the first sentence to state that data would be submitted “via direct, login and upload, and login and attest” as discussed in section III.I.3.h.(1)(b) of this final rule. In addition, we proposed to add further additions to § 414.1360(a)(1) to specify, submit a yes response for each improvement activity that is performed for at least a continuous 90-day period during the applicable performance period.
We did not receive any comments on these proposals. Therefore, we are
In the CY 2017 Quality Payment Program final rule (81 FR 77190), we finalized at § 414.1365 that the improvement activities performance category includes the subcategories of activities provided at section 1848(q)(2)(B)(iii) of the Act. It has since come to our attention that it is unnecessary to have a separate regulation text included under § 414.1365 since the subcategories are not a component of the scoring calculations. Therefore, in the CY 2019 PFS proposed rule (83 FR 35906 through 35907), we proposed to delete § 414.1365 and move the same improvement activities subcategories to § 414.1355(c). We reiterate that we did not propose any changes to the subcategories themselves. These subcategories are:
• Expanded practice access, such as same day appointments for urgent needs and after-hours access to clinician advice.
• Population management, such as monitoring health conditions of individuals to provide timely health care interventions or participation in a QCDR.
• Care coordination, such as timely communication of test results, timely exchange of clinical information to patients or other clinicians, and use of remote monitoring or telehealth.
• Beneficiary engagement, such as the establishment of care plans for individuals with complex care needs, beneficiary self-management assessment and training, and using shared decision making mechanisms.
• Patient safety and practice assessment, such as through the use of clinical or surgical checklists and practice assessments related to maintaining certification.
• Participation in an APM.
• Achieving health equity, such as for MIPS eligible clinicians that achieve high quality for underserved populations, including persons with behavioral health conditions, racial and ethnic minorities, sexual and gender minorities, people with disabilities, people living in rural areas, and people in geographic HPSAs.
• Emergency preparedness and response, such as measuring MIPS eligible clinician participation in the Medical Reserve Corps, measuring registration in the Emergency System for Advance Registration of Volunteer Health Professionals, measuring relevant reserve and active duty uniformed services MIPS eligible clinician activities, and measuring MIPS eligible clinician volunteer participation in domestic or international humanitarian medical relief work.
• Integrated behavioral and mental health, such as measuring or evaluating such practices as: Co-location of behavioral health and primary care services; shared/integrated behavioral health and primary care records; cross training of MIPS eligible clinicians, and integrating behavioral health with primary care to address substance use disorders or other behavioral health conditions, as well as integrating mental health with primary care.
The following is a summary of the public comments received on our proposals and our responses:
After consideration of the public comments received, we are finalizing our proposal, as proposed, to delete § 414.1365 and move the same improvement activities subcategories to § 414.1355(c).
In the CY 2019 PFS proposed rule (83 FR 35907 through 35910), we proposed to: (1) Adopt one new criterion and remove one existing criterion for nominating new improvement activities beginning with the CY 2019 performance period and future years; (2) modify the timeframe for the Annual Call for Activities; (3) add 6 new improvement activities for the CY 2019 performance period and future years; (4) modify 5 existing improvement activities for the CY 2019 performance period and future years; and (5) remove 1 existing improvement activity for the CY 2019 performance period and future years. We are also making clarifications to: (1) Considerations for selecting improvement activities for the CY 2019 performance period and future years; and (2) the weighting of improvement activities.
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. For Year 2, we provided an informal process for submitting new improvement activities or modifications for potential inclusion in the comprehensive Improvement Activities Inventory for the Quality Payment Program Year 2 and future years through subregulatory guidance (
In the CY 2019 PFS proposed rule (83 FR 35907 through 35908), we proposed to add one new criterion and remove a previously adopted criterion from the improvement activities nomination criteria. We also clarified our considerations in selecting improvement activities.
In the CY 2017 Quality Payment Program final rule (81 FR 77190 through 77195), we discussed guidelines for the selection of improvement activities. In the CY 2018 Quality Payment Program final rule, we formalized the Annual Call for Activities process for Year 3 and future years and added additional criteria; stakeholders would apply one or more of the below criteria when submitting nominations for improvement activities (82 FR 53660):
• 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.
We believe it is important to place attention on public health emergencies, such as the opioid epidemic, when considering improvement activities for inclusion in the Inventory, because their inclusion raises awareness for clinicians about the urgency of the situation and to promote clinician adoption of best practices to combat those public health emergencies. A list of the public health emergency declarations is available at
The following is a summary of the public comments received on our proposals and our responses:
After consideration of the public comments received, we are finalizing our proposal, as proposed to adopt an additional criterion entitled “Include a public health emergency as determined by the Secretary” to the criteria for nominating new improvement activities beginning with the CY 2019 performance period and future years.
In the CY 2017 Quality Payment Program final rule (81 FR 77202 through 77209), we adopted a policy to award a bonus to the Promoting Interoperability performance category score for MIPS eligible clinicians who use CEHRT to complete certain activities in the improvement activities performance category. We 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 Promoting Interoperability (formerly Advancing Care Information) bonus codified at § 414.1380(b)(4)(i)(D).
In the CY 2019 PFS proposed rule (83 FR 35982), under the Promoting Interoperability performance category, we proposed a new approach for scoring that moves away from the base, performance, and bonus score methodology currently established. This new approach removes the availability of a bonus score for attesting to completing one or more specified improvement activities using CEHRT beginning with the CY 2019 performance period and future years. As a result, we do not believe the criterion for selecting improvement activities for inclusion in the program entitled “Activities that may be considered for an advancing care information bonus” remains relevant. Therefore, we proposed to remove the criterion for selecting improvement activities for inclusion in the program entitled “Activities that may be considered for an advancing care information bonus”
If our proposals to add one criterion and remove one criterion are adopted as proposed, the new list of criteria for nominating new improvement activities for the CY 2019 performance period and future years would be as follows:
• 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;
• 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;
• Include a public health emergency as determined by the Secretary; or
• CMS is able to validate the activity.
We did not receive any comments on our proposal. Therefore, we are finalizing our proposal, as proposed, to remove the criterion entitled “Activities that may be considered for an advancing care information bonus” beginning with the CY 2019 performance period and future years. We note that this policy is being finalized in alignment with those in section III.I.3.h.(5)(d)(ii) of this final rule.
As noted in the CY 2017 Quality Payment Program final rule, we intend to use the criteria for nominating new improvement activities in selecting improvement activities for inclusion in the program (82 FR 53659). However, we clarify here that those criteria are but one factor in determining which improvement activities we ultimately propose. For example, we also generally take into consideration other factors, such as whether the nominated improvement activity uses publically available products or techniques (that is, does not contain proprietary products or information limiting an activity) or whether the nominated improvement activity duplicates any currently adopted activity (83 FR 35908).
Given stakeholder feedback requesting additional transparency regarding the weighting of improvement activities (82 FR 53657), in the CY 2019 PFS proposed rule (83 FR 35908 through 35909), we summarized considerations we have previously used to assign weights to improvement activities included in the Improvement Activities Inventory (see Appendix 2: Improvement Activities, Tables A and B). We also made a few clarifications and solicited comment for future weighting considerations. These topics are discussed in more detail below.
In the CY 2017 Quality Payment Program final rule (81 FR 77191), we explained that to define the criteria and establish weighting for each activity, we engaged multiple stakeholder groups, including the Centers for Disease Control and Prevention, Health Resources and Services Administration, Office of the National Coordinator for Health Information Technology, SAMHSA, Agency for Healthcare Research and Quality, Food and Drug Administration, the Department of Veterans Affairs, and several clinical specialty groups, small and rural practices and non-patient facing clinicians. Activities were proposed to be weighted as high based on the extent to which they align with activities that support the patient-centered medical home, since that is the standard under section 1848(q)(5)(C)(i) of the Act for achieving the highest potential score for the improvement activities performance category, as well as with our priorities for transforming clinical practice (81 FR 77191). 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) were also proposed to be weighted as high (81 FR 77191). We also stated that 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 (81 FR 77194). In the past, we have given certain improvement activities high-weighting due to the intensity of the activity; for example, one improvement activity was changed to high-weighting because it often involves travel and work under challenging physical and clinical circumstances (81 FR 77194). Also, we note that successful participation in the CMS Study on Factors Associated with Reporting Quality Measures as discussed in section III.I.3.h.(4)(e) of this final rule would result in full credit for the improvement activities performance category of 40 points; if participants do not meet the study guidelines, they will need to follow the current improvement activities guidelines (81 FR 77197).
In this final rule, we are clarifying: (a) Our consideration of giving high-weighting due to activity intensity; and (b) differences between high- and medium-weighting.
As stated previously, we have given certain improvement activities high-weighting due to the intensity of the activity (81 FR 77194). To elaborate, we believe that an activity that requires significant investment of time and resources should be high-weighted. For example, we finalized the CAHPS for MIPS survey as high-weighted (81 FR 77827), because it requires a significant investment of time and resources. As part of the requirements of this activity, MIPS eligible clinicians: (1) Must register for the CAHPS for MIPS survey; (2) must select and authorize a CMS-approved survey vendor to collect and report survey data using the survey and specifications provided by us; and (3) are responsible for vendor's costs to collect and report the survey (ranges from approximately $4,000 to $7,000 depending on services requested).
In contrast, we believe medium-weighted improvement activities are simpler to complete and require less time and resources as compared to high-weighted improvement activities. For example, we finalized the Cost Display for Laboratory and Radiographic Orders improvement activity as medium-weighted (82 FR 54188), because the information required to be used is readily available (
We recognize that we did not previously explicitly state separate considerations for medium-weighted activities. This is because an improvement activity is only either high or medium-weighted. In this final rule, we are clarifying that an improvement activity is by default medium-weight unless it meets considerations for high-weighting as discussed previously (83 FR 35909).
We intend to more thoroughly revisit our improvement activity weighting policies in next year's rulemaking. We invited public comment on the need for additional transparency and guidance on the weighting of improvement activities as we work to refine the Annual Call for Activities process for future years. Furthermore, in light of the finalized policy to remove bonus points for improvement activities that may be applicable to the Promoting Interoperability performance category as discussed in sections III.I.3.h.(4)(d)(i)(A)(cc) and III.I.3.h.(5)(d)(ii), we recognize the need to continue incentives for CEHRT. Therefore, for future consideration, we solicited comment on potentially applying high-weighting for any improvement activity employing CEHRT. We also invited public comment on any other additional considerations for high- or medium-weighting.
In the CY 2018 Quality Payment Program final rule (82 FR 53660), we finalized that we would accept submissions for prospective improvement activities and modifications to existing improvement activities at any time during the performance period to be added to the Improvement Activities Under Review (IAUR) list, for the applicable performance period, which would be displayed on a CMS website following the close of the Annual Call for Activities. In addition, we finalized that for the Annual Call for Activities, only nominations and modifications submitted by March 1st would be considered for inclusion in the IAUR list and Improvement Activities Inventory for the performance period occurring in the following calendar year (82 FR 53660). For example, for the CY 2018 Annual Call for Activities, we received nominations for new and modified improvement activities from February 1st through March 1st. Currently, an improvement activity nomination submitted during the CY 2018 Annual Call for Activities would be vetted in CY 2018, and after review, if accepted by CMS, would be proposed during the CY 2018 rulemaking cycle for possible implementation in the CY 2019 performance period and future years.
However, the previously established timeline, which includes prospective new and modified improvement activities submission period, review, and publication of proposed improvement activities for implementation in the next performance period, has become operationally challenging. Based on our experience over the past 2 years, we have found that processing and reviewing the volume of improvement activities nominations requires more time than originally thought. In addition, preparations and drafting for annual rulemaking begin around the time of the close date for the current Annual Call for Activities (that is, March 1st), leaving incorporation into the proposed rule challenging. Therefore, in the CY 2019 PFS proposed rule, beginning with the CY 2019 performance period, we proposed to: (1) Delay the year for which nominations of prospective new and modified improvement activities would apply; and (2) expand the submission timeframe/due date for nominations (83 FR 35909).
Beginning with the CY 2019 performance period, we proposed to change the performance year for which the nominations of prospective new and modified improvement activities would apply, such that improvement activities nominations received in a particular year will be vetted and considered for the next year's rulemaking cycle for possible implementation in a future year. This timeframe parallels the Promoting Interoperability performance category Annual Call for EHR Measures timeframe available at
Second, beginning with the CY 2019 performance period, we proposed to change the submission timeframe for the Annual Call for Activities from February 1st through March 1st to February 1st through June 30th, providing approximately 4 additional months for stakeholders to submit nominations. We believe this change would assist stakeholders by providing additional time to submit improvement activities nominations. Consistent with previous policy, nominations for prospective new and modified improvement activities would be accepted during the Annual Call for Activities time period only and would be included in the IAUR displayed on a CMS website following the close of the Annual Call for Activities (83 FR 35909).
The following is a summary of the public comments received on our proposals and our responses:
After consideration of the public comments received on our proposal, we are finalizing our proposal, as proposed, to change the performance year for which the nominations of prospective new and modified improvement activities would apply, such that beginning with the CY 2019 performance period, improvement activities nominations received in a particular year will be vetted and considered for the next year's rulemaking cycle for possible implementation in a future year. In addition, we are finalizing our proposal, as proposed, to change the submission timeframe for the Annual Call for Activities from February 1st through March 1st to February 1st through June 30th, providing approximately 4 additional months for stakeholders to submit nominations beginning with the CY 2019 performance period.
In the CY 2018 Quality Payment Program final rule (82 FR 53660), we finalized that we would add new improvement activities to the Improvement Activities Inventory through notice-and-comment rulemaking. We referred readers to Table H in the Appendix of the CY 2017 Quality Payment Program final rule (81 FR 77177 through 77199) and Table F and G in the Appendix of the CY 2018 Quality Payment Program final rule (82 FR 54175 through 54229) for our previously finalized Improvement Activities Inventory. In the CY 2019 PFS proposed rule (83 FR 36359 through 36368), for CY 2019 performance period and future years, we proposed 6 new improvement activities; we also proposed to: (1) Modify 5 existing activities; and (2) remove 1 existing activity. We also proposed changes to our CMS Study on Factors Associated with Reporting Quality Measures in section III.I.3.h.(4)(e) of this final rule.
A summary of the public comments received on specific improvement activities proposals and our responses may be found in Tables A and B of Appendix 2: Improvement Activities in this final rule.
In the CY 2017 Quality Payment Program final rule (81 FR 77195), we created the Study on Improvement Activities and Measurement. In CMS' quest to create a culture of improvement using evidence based medicine on a consistent basis, fully understanding the strengths and limitations of the current processes is crucial to better understand and improve these current processes. We proposed to conduct a study on clinical improvement activities and measurement to examine clinical quality workflows and data capture using a simpler approach to quality measures (81 FR 77196). The lessons learned in this study on practice improvement and measurement may influence changes to future MIPS data submission requirements. The goals of the study are to see whether there will be improved outcomes, reduced burden in reporting, and enhancements in clinical care by selected MIPS eligible clinicians (81 FR 77196). This study shall inform us on the root causes of clinicians' performance measure data collection and submission burdens, as well as challenges that hinder accurate and timely quality measurement activities. Our goals are to use high quality, low cost measures that are meaningful, easy to understand, operable, reliable, and valid. As discussed in the CY 2017 Quality Payment Program final rule (81 FR 77195) the CMS Study on Burden Associated with Quality Reporting goals are to see whether there will be improved outcomes, reduced burden in reporting, and enhancements in clinical care by selected MIPS eligible clinicians desiring:
• A more data driven approach to quality measurement.
• Measure selection unconstrained by a CEHRT program or system.
• Improving data quality submitted to CMS.
• Enabling CMS to get data more frequently and provide feedback more often.
This study evolved into “CMS Study on Burdens Associated with Reporting Quality Measures” in the CY 2018 Quality Payment Program final rule (82 FR 53662).
This study is ongoing, participants are recruited on a yearly basis for a minimum period of 3 years, and current participants can opt-in or out when the study year ends (81 FR 77195). Successful participation in the study would result in full credit for the improvement activities performance category of 40 points; if participants do not meet the study guidelines, they will need to follow the current improvement activities requirements (81 FR 77197). To meet the study requirements, study participants must partake in two web-based survey questionnaires, submit data for at least three MIPS clinician quality measures to CMS during the CY 2019 performance period, and be available for selection and participation in at least one focus group meeting (82 FR 53662).
Although we did not propose any changes to the study purpose, aim, eligibility, or credit, in the CY 2019 PFS proposed rule (83 FR 35910 through 35911), we proposed, for the CY 2019 performance period and future years, changes to the: (1) Title of the study; (2) sample size to allow enough statistical power for rigorous analysis within some categories, (3) focus group and survey requirements; and (4) measure requirements. These proposals are discussed in more detail below.
In the CY 2019 PFS proposed rule (83 FR 35910), beginning with the CY 2019 performance period, we proposed to change the title of the study from “CMS Study on Burdens Associated with Reporting Quality Measures” to “CMS Study on Factors Associated with Reporting Quality Measures” to more accurately reflect the study's intent and purpose. To assess the root causes of clinician burden associated with the collection and submission of clinician quality measures for MIPS, as depicted in CY 2017 Quality Payment Program final rule (81 FR 77195), replacing “Burden” with “Factors” in the title will eliminate possible response or recall bias that may occur with data collection. Having “burden” in the study title may elicit the tendency of survey participants reporting more on their perception of burden and challenges, and/or suppressing other factors that are associated with their quality measure data collection and submission, that may be relevant to examining the root cause of burden.
The following is a summary of the public comments related to our proposal and our response:
After consideration of the comments, we are finalizing our proposal, as proposed, to change the title of the study from “CMS Study on Burdens Associated with Reporting Quality Measures” to “CMS Study on Factors Associated with Reporting Quality Measures” beginning with the CY 2019 performance period.
In the CY 2017 Quality Payment Program final rule (81 FR 77196), we initially finalized a sample size of 42 participants (comprising of groups and individual MIPS eligible facilities). In the CY 2018 Quality Payment Program final rule (82 FR 53661), we increased that number and finalized a sample size of a minimum of 102 individual and group participants for performance periods occurring in CY 2018 for the following categories:
• 20 urban individuals or groups of <3 eligible clinicians—(broken down into 10 individuals & 10 groups).
• 20 rural individuals or groups of <3 eligible clinicians—(broken down into 10 individuals & 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 & 3 rural).
• 6 specialty groups—(broken down into 3 reporting individually & 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 2019 PFS proposed rule (83 FR 35910 through 35911), we proposed to again increase the sample size for the CY 2019 performance period and future years from a minimum of 102 to a minimum of 200 MIPS eligible clinicians, which will enable us to more rigorously analyze the statistical difference between the burden and factors associated within the categories listed above. This proposed increase in sample size would provide the minimum sample needed to get a significant result with adequate statistical power to determine whether there are any statistically significant differences in quality measurement data submission associated with: (1) The size of practice or facility; (2) clinician specialty of practice; (3) region of practice; (4) individual or group reporting; and (5) clinician quality measure type. This rigorous statistical analysis is important, because it facilitates tracing the root causes of measurement burdens and data submission errors that may be associated with various sub-groups of clinician practices using quantitative analytical methods. We believe that a larger sample size would also account for any attrition (drop out of study participants before the study ends). Therefore, we proposed that the new sample size distribution would be:
• 40 urban individuals or groups of <3 eligible clinicians—(broken down into 20 individuals & 20 groups).
• 40 rural individuals or groups of <3 eligible clinicians—(broken down into 20 individuals & 20 groups).
• 20 groups of 3-8 eligible clinicians.
• 20 groups of 8-20 eligible clinicians.
• 20 groups of 20-100 eligible clinicians.
• 20 groups of 100 or greater eligible clinicians.
• Up to 6 groups of >20 eligible clinicians reporting as individuals—(broken down into 3 urban & 3 rural).
• Up to 6 specialty groups—(broken down into 3 reporting individually & 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).
The following is a summary of the public comments related to our proposals and our responses:
After consideration of the comments received, we are finalizing our proposal, as proposed, to increase the sample size for the CY 2019 performance period and future years from a minimum of 102 to a minimum of 200 MIPS eligible clinicians.
We previously finalized in the CY 2017 Quality Payment Program final rule (81 FR 77195) that for the transition year of MIPS, study participants were required to attend a monthly focus group to share lessons learned in submitting quality data along with providing survey feedback to monitor effectiveness. The focus group includes providing visual displays of data, workflows, and best practices to share amongst the participants to obtain feedback and make further improvements (81 FR 77196). The focus groups are used to learn from the practices about how to be more agile as we test new ways of measure recording and workflow (81 FR 77196). In the CY 2018 Quality Payment Program final rule (82 FR 53662), for Year 2 and future years, we reduced that requirement and finalized that study participants would be required to complete at least two web-based survey questionnaire and attend up to 4 focus group sessions throughout the year, but certain study participants would be able to attend less frequently. Each study participant is required to complete a survey prior to submitting MIPS data and another survey after submitting MIPS data (82 FR 53662). The purpose of reducing focus group attendance and survey participation was to ease requirements for MIPS eligible clinicians or group of clinicians who may have nothing new to contribute, without compromising the minimum sample needed for focus groups. For example, if a MIPS eligible clinician submitted all 6 measures after collecting 90 days of data and attended the first available focus group and/or survey, the clinician may have nothing new or relevant to discuss with the research team on subsequent focus groups and/or surveys.
Although we proposed in the section previously to increase the sample size of the study to a minimum of 200 MIPS eligible clinicians, we do not believe we need focus groups for the entirety of that population. We believe that requiring focus groups for all proposed minimum of 200 MIPS eligible clinicians would only result in bringing the data to a saturation point, a situation whereby the same themes and information are recurring, and no new insights are given by additional sources of data from focus groups.
Instead, we believe that selecting a subset of clinicians, purposively, to participate in focus groups would be a more appropriate approach because that would allow us to understand the experience of select clinicians without imposing undue burden on all. This study is voluntary as clinicians nominate themselves to participate and we select a cohort from among these volunteers. Therefore, in the CY 2019 PFS proposed rule (83 FR 35911), we proposed to make the focus group participation a requirement only for a selected subset of the study participants, using purposive sampling and random sampling methods, beginning with the CY 2019 performance period and future years. Those selected would be required to participate in at least one focus group meeting and complete survey requirement, in addition to all the other study requirements. As previously established, each study participant is required to complete a survey prior to submitting MIPS data and another survey after submitting MIPS data. This requirement would continue to apply for each selected subset participating in a focus group.
We did not receive any comments on our proposal. Therefore, we are finalizing our proposals, as proposed, to make the focus group participation a requirement only for a selected subset of the study participants, using purposive sampling and random sampling methods, beginning with the CY 2019 performance period and future years. Those selected would be required to participate in at least one focus group meeting and complete the survey requirements, in addition to all the other study requirements (81 FR 77195).
In the CY 2017 Quality Payment Program final rule (81 FR 77196), we finalized that for CY 2017, MIPS eligible clinicians or groups participating in the CMS Study would submit their data and workflows for a minimum of three MIPS clinician quality measures that are relevant and prioritized by their practice. One of the measures must be an outcome measure, and one must be a patient experience measure (81 FR 77196). We also finalized that for future years, participating MIPS eligible clinicians or groups would select three of the measures for which they have baseline data from the 2017 performance period to compare against later performance years. We note that participating MIPS eligible clinicians could elect to report on more measures originally as this would provide more options from which to select in subsequent years for purposes of measuring improvement. In the CY 2018 Quality Payment Program final rule, we finalized for the Quality Payment Program Year 2 and future years, that study participants could submit all their quality measures data at once, as it is done in the MIPS program, (
In the CY 2019 PFS proposed rule (83 FR 35911), we proposed to continue the previously required minimum number of measures. That is, for the CY 2019 performance period and future years: participants must submit data and workflows for a minimum of three MIPS quality measures for which they have baseline data. However, instead of requiring one outcome measure and one patient experience measure as previously finalized, we proposed that, for the CY 2019 performance period and future years, at least one of the minimum of three measures must be a high priority measure as defined at
We did not receive any comments on our proposal. Therefore, we are finalizing our proposal, as proposed, that for the CY 2019 performance period and future years, at least one of the minimum of three measures must be a high priority measure as defined at § 414.1305.
We note that although the aforementioned activities (that is, the CMS Study on Factors Associated with Reporting Quality Measures) constitute an information collection request as defined in the implementing regulations of the Paperwork Reduction Act of 1995 (5 CFR part 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 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.
Section 1848(q)(2)(A) of the Act includes the meaningful use of CEHRT as a performance category under the MIPS. In prior rulemaking, we referred 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.
In this final rule, we are adopting several scoring and measurement policies that will bring the performance category to a new phase of EHR measurement with an increased focus on interoperability and improving patient access to health information. To better reflect this focus, we renamed the advancing care information performance category to the Promoting Interoperability (PI) performance category. We believe this change will help highlight the enhanced goals of this performance category. We are finalizing revisions to the regulation text under 42 CFR part 414, subpart O, to reflect the new name.
Under the definition of CEHRT under § 414.1305, for the performance periods in 2017 and 2018, MIPS eligible clinicians had flexibility to use EHR technology certified to either the 2014 or 2015 Edition certification criteria, or a combination of the two Editions, to meet the objectives and measures specified for the Promoting Interoperability performance category (82 FR 53671 through 53672). As we finalized previously (82 FR 53671-53672) beginning with the performance period in 2019, MIPS eligible clinicians must use EHR technology certified to the 2015 Edition certification criteria as specified at § 414.1305. We believe it is appropriate to require the use of 2015 Edition CEHRT beginning in CY 2019. In reviewing the state of health information technology, it is clear the 2014 Edition certification criterion are out of date and insufficient for clinician needs in the evolving health information technology (IT) industry. It will be beneficial to health IT developers and health care providers to move to more up-to-date standards and functions that better support interoperable exchange of health information and improve clinical workflows.
We received many comments regarding the requirement to use the 2015 Edition of CEHRT beginning in 2019. As we stated in the CY 2019 PFS proposed rule (83 FR 35912 through 35913), we did not propose to change the requirement. Because the requirement was not a subject of this rulemaking, we are not responding to the comments we received, although we may consider them to inform our future policy making in this subject area.
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 Promoting Interoperability performance category. Accordingly, under § 414.1375(a), the Promoting Interoperability performance category comprises 25 percent of a MIPS eligible clinician's final score for the 2019 MIPS payment year and each MIPS payment year thereafter, unless we assign a different scoring weight. We proposed to revise § 414.1375(a) (83 FR 35913) to specify the various sections of the statute (sections 1848(o)(2)(D), 1848(q)(5)(E)(ii), and 1848(q)(5)(F) of the Act) under which a different scoring weight may be assigned for the Promoting Interoperability performance category. We established the reporting criteria to earn a performance category score for the Promoting Interoperability performance category under § 414.1375(b). We proposed to revise § 414.1375(b)(2)(i) to replace the reference to “each required measure” with “each base score measure” to improve the precision of the text. Under § 414.1380(b)(4), the Promoting Interoperability performance category score is comprised of a score for participation and reporting, known as the “base score,” and a score for performance at varying levels above the base score requirements, known as the “performance score,” as well as any applicable bonus scores. We proposed several editorial changes to § 414.1380(b)(4) in an effort to more clearly and concisely capture the previously established policies. For further explanation of our scoring policies for performance periods in 2017 and 2018 for the Promoting Interoperability performance category, we refer readers to 81 FR 77216 through 77227 and 82 FR 53663 through 53664.
A general summary overview of the scoring methodology for the performance period in 2018 is provided in the Table 38.
We did not receive any comments on the proposed revisions to the regulation text at §§ 414.1375(a) and (b)(2)(i), and § 414.1380(b)(4). We are finalizing these revisions as proposed.
We heard from many stakeholders that the current scoring methodology is complicated and difficult to understand. By providing flexibility and offering clinicians multiple measures to choose from within the performance score, it appears some clinicians may have been confused by the options. Other MIPS eligible clinicians have indicated that they dislike the base score because it is a required set of measures and provides no flexibility because the scoring is all or nothing. If a MIPS eligible clinician cannot fulfill the base score, they cannot
Based on the concerns expressed by stakeholders, we proposed a new scoring methodology (83 FR 35913-395918) and moved away from the base, performance and bonus score methodology that we currently use. We stated our belief that this change would provide a simpler, more flexible, less burdensome structure, allowing MIPS eligible clinicians to put their focus back on patients. The introduction of this new scoring methodology would continue to encourage MIPS eligible clinicians to push themselves on measures that are most applicable to how they deliver care to patients, instead of focusing on measures that may not be as applicable to them. Our goal was to provide increased flexibility to MIPS eligible clinicians and enable them to focus more on patient care and health data exchange through interoperability. Additionally, we wanted to align the requirements of the Promoting Interoperability performance category with the requirements of the Medicare Promoting Interoperability Program for eligible hospitals and CAHs as we had proposed in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20515 through 20537). As the distinction between ambulatory and inpatient CEHRT has diminished and more clinicians are sharing hospitals' CEHRT, we stated our belief that aligning the requirements between programs would lessen the burden on health care providers and facilitate their participation in both programs.
In the CY 2019 PFS proposed rule (83 FR 35914 through 35918), we proposed a new scoring methodology, beginning with the performance period in 2019, to include a combination of new measures, as well as the existing Promoting Interoperability performance category measures, broken into a smaller set of four objectives and scored based on performance. We stated our belief that this would be an overhaul of the existing program requirements as it would eliminate the concept of base and performance scores. We proposed a smaller set of objectives that consisted of e-Prescribing, Health Information Exchange, Provider to Patient Exchange, and Public Health and Clinical Data Exchange. We proposed these objectives to promote specific HHS priorities and satisfy the requirements of section 1848(o)(2) of the Act. We included the e-Prescribing and Health Information Exchange objectives in part to capture what we believe are core goals for the 2015 Edition of CEHRT and also to satisfy the statutory requirements. These core goals promote interoperability between health care providers and health IT systems to support safer, more coordinated care. The Provider to Patient Exchange objective promotes patient awareness and involvement in their health care through the use of APIs, and ensures patients have access to their medical data. Finally, the Public Health and Clinical Data Exchange objective supports the ongoing systematic collection, analysis, and interpretation of data that may be used in the prevention and controlling of disease through the estimation of health status and behavior. The integration of health IT systems into the national network of health data tracking and promotion improves the efficiency, timeliness, and effectiveness of public health surveillance. We stated our belief that it is important to keep these core goals, primarily because these objectives promote interoperability between health care providers and health IT systems to support safer, more coordinated care while ensuring patients have access to their medical data.
Under the proposed scoring methodology, MIPS eligible clinicians would be required to report certain measures from each of the four objectives, with performance-based scoring occurring at the individual measure-level. Each measure would be scored based on the MIPS eligible clinician's performance for that measure, based on the submission of a numerator and denominator, except for the measures associated with the Public Health and Clinical Data Exchange objective, which require “yes or no” submissions. Each measure would contribute to the MIPS eligible clinician's total Promoting Interoperability performance category score. The scores for each of the individual measures would be added together to calculate the Promoting Interoperability performance category score of up to 100 possible points for each MIPS eligible clinician. In general, the Promoting Interoperability performance category score makes up 25 percent of the MIPS final score. If a MIPS eligible clinician fails to report on a required measure or claim an exclusion for a required measure if applicable, the clinician would receive a total score of zero for the Promoting Interoperability performance category.
We also considered an alternative approach in which scoring would occur at the objective level, instead of the individual measure level, and MIPS eligible clinicians would be required to report on only one measure from each objective to earn a score for that objective. Under this scoring methodology, instead of six required measures, the MIPS eligible clinician total Promoting Interoperability performance category score would be based on only four measures, one measure from each objective. Each objective would be weighted similarly to how the objectives are weighted in our proposed methodology, and bonus points would be awarded for reporting any additional measures beyond the required four. We solicited public comment on this alternative approach, and whether additional flexibilities should be considered, such as allowing MIPS eligible clinicians to select which measures to report on within an objective and how those objectives should be weighted, as well as whether additional scoring approaches or methodologies should be considered.
In our proposed scoring methodology, the e-Prescribing objective would contain three measures each weighted differently to reflect their potential availability and applicability to the clinician community. In addition to the existing e-Prescribing measure, we proposed to add two new measures to the e-Prescribing objective: Query of Prescription Drug Monitoring Program (PDMP); and Verify Opioid Treatment Agreement. For more information about these two proposed measures, we refer readers to section III.H.3.h.(5)(f) of the proposed rule (83 FR 35922 through 35925). The e-Prescribing measure would be required for reporting and weighted at 10 points because we believed it would be applicable to most MIPS eligible clinicians. In the event that a MIPS eligible clinician meets the criteria and claims the exclusion for the e-Prescribing measure in 2019, the 10 points available for that measure would be redistributed equally among the two measures under the Health Information Exchange objective:
• Support Electronic Referral Loops By Sending Health Information Measure (25 points).
• Support Electronic Referral Loops By Receiving and Incorporating Health Information (25 points).
We solicited public comment on whether this redistribution is appropriate for 2019, or whether the points should be distributed differently.
The Query of PDMP and Verify Opioid Treatment Agreement measures would be optional for the MIPS performance period in 2019. These new measures may not be available to all MIPS eligible clinicians for the MIPS performance period in 2019 as they may not have been fully developed by their health IT vendor, or not fully implemented in time for data capture and reporting. Therefore, we did not propose to require these two new measures in 2019, although MIPS eligible clinicians may choose to report them and earn up to 5 bonus points for each measure. We proposed to require these measures beginning with the MIPS performance period in 2020, and we solicited public comment on this proposal.
Due to varying state requirements, not all MIPS eligible clinicians would be able to e-prescribe controlled substances, and thus, these measures would not be available to them. For these reasons, in the CY 2019 PFS proposed rule (83 FR 35915 through 35916) we proposed an exclusion for these two measures beginning with the MIPS performance period in 2020. The exclusion would provide that any MIPS eligible clinician who is unable to report the measure in accordance with applicable law would be excluded from reporting the measure, and the 5 points assigned to that measure would be redistributed to the e-Prescribing measure.
As the two new opioid measures become more broadly available in CEHRT, we proposed each of the three measures within the e-Prescribing objective would be worth 5 points beginning with the MIPS performance period in 2020. Requiring these two measures would add 10 points to the maximum total score for the Promoting Interoperability performance category as these measures would no longer be eligible for optional bonus points. To maintain a maximum total score of 100 points, beginning with the MIPS performance period in 2020, we proposed to reweight the e-Prescribing measure from 10 points down to 5 points, and reweight the Provide Patients Electronic Access to Their Health Information measure from 40 points down to 35 points as illustrated in Table 38. We proposed that if the MIPS eligible clinician qualifies for the e-Prescribing exclusion and is excluded from reporting all three of the measures associated with the e-Prescribing objective as described in section III.H.3.h.(5)(f) of the proposed rule, (83 FR 35921) the 15 points for the e-Prescribing objective would be redistributed evenly among the two measures associated with the Health Information Exchange objective and the Provide Patients Electronic Access to their Health Information measure by adding 5 points to each measure.
We refer readers to section III.I.3.h.(5)(f) of this final rule, where we discuss the Promoting Interoperability performance category measures, for a discussion of the comments we received regarding the above-referenced proposed scoring methodology for the e-Prescribing objective and associated measures. After consideration of the public comments we received, we are finalizing our proposed scoring for the E-Prescribing objective as proposed but with the modifications discussed at the end of this section III.I.3.h.(5)(f) of the preamble of this final rule. The e-Prescribing measure is finalized with modification, the Query of PDMP measure is finalized with modification, and the Verify Opioid Treatment Agreement measure is finalized with modification. In addition, we refer readers to section III.I.3.h.(5)(f)(ii) of the preamble of this final rule where we discuss our reasons for adopting the Query of PDMP measure with modification and the Verify Opioid Treatment Agreement measure with modification.
For the Health Information Exchange objective, we proposed to change the name of the existing Send a Summary of Care measure to Support Electronic Referral Loops by Sending Health Information measure, and proposed a new measure which combines the functionality of the existing Request/Accept Summary of Care and Clinical Information Reconciliation measures into a new measure, Support Electronic Referral Loops by Receiving and Incorporating Health Information measure. For more information about the proposed measure and measure changes, we refer readers to section III.I.3.h.(5)(f) of the proposed final rule (83 FR 35925 through 35928). MIPS eligible clinicians would be required to report both of these measures, each worth 20 points toward their total Promoting Interoperability performance category score. These measures are weighted heavily to emphasize the importance of sharing health information through interoperable exchange in an effort to promote care coordination and better patient outcomes. Similar to the two new measures in the e-Prescribing objective, the new Support Electronic Referral Loops by Receiving and Incorporating Health Information measure may not be available to all MIPS eligible clinicians as it may not have been fully developed by their health IT vendor, or not fully implemented in time for a MIPS performance period in 2019. For these reasons, we proposed two exclusions for the Support Electronic Referral Loops by Receiving and Incorporating Health Information measure:
1. Any MIPS eligible clinician who is unable to implement the measure for a MIPS performance period in 2019 would be excluded from this measure.
2. Any MIPS eligible clinician who receives fewer than 100 transitions of care or referrals or has fewer than 100 encounters with patients never before encountered during the performance period would be excluded from this measure.
We note that these two exclusions for the measure were proposed in different sections of the proposed rule (83 FR 35916, 35927).
In the event that a MIPS eligible clinician claims an exclusion for the Support Electronic Referral Loops by Receiving and Incorporating Health Information measure, the 20 points would be redistributed to the Support Electronic Referral Loops by Sending Health Information measure, and that measure would then be worth 40 points. We solicited public comment on whether this redistribution is appropriate, or whether the points should be redistributed to other measures instead.
We refer readers to section III.I.3.h.(5)(f) of this final rule, where we discuss the Promoting Interoperability performance category measures, for a discussion of the comments we received regarding the above-referenced proposed scoring methodology for the Health Information Exchange objective and associated measures. We did not receive any comments regarding the redistribution of points if an exclusion is claimed for the Support Electronic Referral Loops by Receiving and Incorporating Health Information measure. After consideration of the comments that we received, we are finalizing our proposals for the Health Information Exchange objective as proposed. In addition, measure specification details can be found in section III.I.3.h.(5)(f) of the preamble of this final rule.
In the CY 2019 PFS proposed rule (83 FR 359186), we proposed to weight the
We solicited comment on these proposals and our summary and response are below.
After consideration of the comments, we are finalizing with modification the proposals for the Provider to Patient Exchange objective. The Provide Patients Electronic Access to Their Health Information measure will be worth up to 40 points beginning in CY 2019. We had proposed that the measure would be worth up to 35 points beginning in CY 2020, but we are not finalizing that proposal because we are not requiring the Verify Opioid Treatment Agreement measure beginning in CY 2020 as proposed, which would have been worth up to 5 points. For additional measure information, we refer readers to section III.I.3.h.(5)(f) of the preamble of this final rule.
The measures under the Public Health and Clinical Data Exchange objective are reported using “yes or no” responses and thus we proposed to score those measures on a pass/fail basis in which the MIPS eligible clinician would receive the full 10 points for reporting two “yes” responses, or for submitting a “yes” for one measure and claiming an exclusion for another. If there are no “yes” responses and two exclusions are claimed, the 10 points would be redistributed to the Provide Patients Electronic Access to Their Health Information measure. A MIPS eligible clinician would receive zero points for reporting “no” responses for the measures in this objective if they do not submit a “yes” or claim an exclusion for at least two measures under this objective. We proposed that for this objective, the MIPS eligible clinician would be required to report on two measures of their choice from the following list of measures: Immunization Registry Reporting, Electronic Case Reporting, Public Health Registry Reporting, Clinical Data Registry Reporting, and Syndromic Surveillance Reporting. To account for the possibility that not all of the measures under the Public Health and Clinical Data Exchange objective may be applicable to all MIPS eligible clinicians, we proposed to establish exclusions for these measures as described in section III.H.3.h.(5)(f) of the proposed rule (83 FR 35929 through 35930). If a MIPS eligible clinician claims two exclusions, the 10 points for this objective would be redistributed to the Provide Patients Electronic Access to their Health Information measure under the Provider to Patient Exchange objective, making that measure worth 50 points in 2019 and 45 points beginning in 2020. Reporting more than two measures for this objective would not earn the MIPS eligible clinician any additional points. We refer readers to section III.H.3.h.(5)(f) of the proposed rule (83 FR 35929 through 35930) in regard to the proposals for the Public Health and Clinical Data Exchange objective and its associated measures.
We solicited comment on these proposals and our summary and response are below.
After consideration of the public comments we received, we are finalizing our proposals for the Public Health and Clinical Data Exchange objective with modifications. MIPS eligible clinicians must report to two different public health agencies or clinical data registries for any of the following measures: Syndromic Surveillance Reporting, Immunization Registry Reporting, Electronic Case Reporting, Public Health Registry Reporting, and Clinical Data Registry Reporting. MIPS eligible clinicians may report to two different public health agencies or clinical data registries for purposes of the same measure if they choose. For additional measure information, we refer readers to section III.I.3.h.(5)(f) of this final rule.
In the CY 2019 PFS proposed rule (83 FR 359186), we proposed that the Protect Patient Health Information objective and its associated measure, Security Risk Analysis, would remain part of the requirements for the
The following is a summary of the public comments received on the proposals for the Protect Patient Health Information objective and its associated measure, Security Risk Analysis and our responses.
After consideration of the public comments, we are finalizing our proposal to require MIPS eligible clinicians to attest that they completed the actions included in the Security Risk Analysis measure at some point during the calendar year in which the MIPS performance period occurs. MIPS eligible clinicians who fail to complete these actions or fail to attest will not earn any score for the Promoting Interoperability performance category, regardless of whether they report on other measures for this category.
As we proposed at 83 FR 35916, similar to how MIPS eligible clinicians currently submit data, the MIPS eligible clinician would submit their numerator and denominator data for each measure, and a “yes or no” response for each of the two reported measures under the Public Health and Clinical Data Exchange objective. The numerator and denominator for each measure would then translate to a performance rate for that measure and would be applied to the total possible points for that measure. For example, the e-Prescribing measure was proposed to be worth 10 points. A numerator of 200 and denominator of 250 would yield a performance rate of (200/250) = 80 percent. This 80 percent would be applied to the 10 total points available for the e-Prescribing measure to determine the measure score. A performance rate of 80 percent for the e-Prescribing measure would equate to a measure score of 8 points (performance rate * total possible measure points = points awarded toward the total Promoting Interoperability performance category score; 80 percent * 10 = 8 points). To calculate the Promoting Interoperability performance category score, the measure scores would be added together, and the total sum would be divided by the total possible points (100). The total sum cannot exceed the total possible points. This calculation results in a fraction from zero to 1, which can be formatted as a percent. For further clarification we refer readers to the scoring example that we included in the proposed rule (83 FR 35917).
When calculating the performance rates, measure and objective scores, and the Promoting Interoperability performance category score, we would generally round to the nearest whole
In order to meet statutory requirements and HHS priorities, the MIPS eligible clinician would need to report on all of the required measures across all objectives in order to earn any score at all for the Promoting Interoperability performance category. Failure to report any required measure, or reporting a “no” response on a “yes or no” response measure, unless an exclusion applies would result in a score of zero. We solicited public comment on the proposed requirement to report on all required measures, or whether reporting on a smaller subset of optional measures would be appropriate.
In the proposed rule (83 FR 35917), we sought public comment on whether these measures are weighted appropriately, or whether a different weighting distribution, such as equal distribution across all measures would be better suited to this program and this proposed scoring methodology. We also sought public comment on other scoring methodologies such as the alternative we considered and described earlier in this section.
We solicited comment on these proposals and our summary of these comments and responses are below.
Some commenters stated that requiring MIPS eligible clinicians to report on every single measure or claim an exclusion creates an unfair burden. Other commenters supported the alternative approach because they believe it is less rigid and provides MIPS eligible clinicians with more flexibility to report measures that are part of their workflow.
For additional measure-specific information, we refer readers to section III.I.3.h.(5)(f) the preamble of this final rule.
Tables 41 and 42 reflect the final policy for the objectives, measures, and maximum points available for the MIPS performance periods in CY 2019 and CY 2020. Please note, the maximum points available do not include points that would be redistributed in the event an exclusion is claimed:
Tables 41 and 42 illustrate our final performance-based scoring methodology.
We proposed to codify the proposed new scoring methodology in new paragraphs (b)(4)(ii) and (iii) under § 414.1380 and we are finalizing the proposed regulation text with modification.
The Advancing Care Information (now Promoting Interoperability) performance category Objectives and Measures for the 2018 performance period are as follows. For more information, we refer readers to the CY 2017 Quality Payment Program and CY 2018 Quality Payment Program final rules (81 FR 77227 through 77229, and 82 FR 53674 through 53680, respectively).
In the CY 2019 PFS proposed rule (83 FR 35920 through 35932), we proposed to adopt beginning with the performance period in 2019 the existing Promoting Interoperability objectives and measures as finalized in the CY 2018 Quality Payment Program final rule (82 FR 53674 through 53680) with several proposed changes as discussed herein, including the addition of new measures, removal of some of the existing measures, and modifications to the specifications of some of the existing measures. We did not propose to continue the Promoting Interoperability transition objectives and measures (see 82 FR 53674 through 53676) beyond the 2018 MIPS performance period because the 2015 Edition of CEHRT will be required beginning with the MIPS performance period in 2019. Our intent for these proposed changes is to ensure the measures better focus on the effective use of health IT, particularly for interoperability, and to address concerns stakeholders have raised through public forums and in public comments related to the perceived burden associated with the current measures in the program. As stated in the CY 2017 Quality Payment Program final rule (81 FR 77216) our priority is to finalize reporting requirements for the Promoting Interoperability performance category that incentivizes performance and reporting with minimal complexity and reporting burden. In addition, we acknowledged that while we believe all of the measures of the Promoting Interoperability performance category are important, we must also balance the need for these data with data collection and reporting burden (81 FR 77221).
In CY 2017, we initiated an informal process outside of rulemaking for submission of new Promoting Interoperability performance category measures for potential inclusion in the Year 3 Quality Payment Program proposed rule. We prioritized measures that build on interoperability and health information exchange, the advanced use of CEHRT using 2015 Edition Standards and Certification Criteria, improve program efficiency and flexibility, measure patient outcomes, emphasize patient safety, and support improvement activities and quality performance categories of MIPS. In addition, and as we indicated in the CY 2018 Quality Payment Program proposed rule (82 FR 30079), we sought new measures that may be more broadly applicable to MIPS eligible clinicians who are Nurse Practitioners (NPs), Physician Assistants (PAs), Certified Registered Nurse Anesthetists (CRNAs) and Clinical Nurse Specialists (CNSs).
During this initial submission period, various MIPS eligible clinicians, stakeholders and health IT developers submitted new measures for consideration via an application posted on the CMS website, now hosted at
We proposed to remove six measures from the Promoting Interoperability objectives and measures beginning with the performance period in 2019. Two of
As discussed in the proposed scoring methodology in section III.H.3.h.(5)(f) of the proposed rule, we proposed to add three new measures to the Promoting Interoperability objectives and measures beginning with the performance period in 2019. For the e-Prescribing objective, we proposed the two new measures referenced earlier, Query of PDMP and Verify Opioid Treatment Agreement, both of which support HHS initiatives related to the treatment of opioid and substance use disorders by helping health care providers avoid inappropriate prescriptions, improving coordination of prescribing amongst health care providers and focusing on the advanced use of CEHRT. For the Health Information Exchange objective, we proposed a new measure, Support Electronic Referral Loops by Receiving and Incorporating Health Information, which builds upon and replaces the existing Request/Accept Summary of Care and Clinical Information Reconciliation measures, while furthering interoperability and the exchange of health information.
We also proposed to modify some of the existing Promoting Interoperability performance category objectives and measures beginning with the performance period in 2019. We proposed to rename the Send a Summary of Care measure to Support Electronic Referral Loops by Sending Health Information. In addition, we proposed to rename the Patient Electronic Access objective to Provider to Patient Exchange, and proposed to rename the remaining measure, Provide Patient Access to Provide Patients Electronic Access to Their Health Information. We proposed to eliminate the Coordination of Care Through Patient Engagement objective and all of its associated measures as described earlier. Finally, we proposed to rename the Public Health and Clinical Data Registry Reporting objective to Public Health and Clinical Data Exchange and require reporting on at least two measures of the MIPS eligible clinician's choice from the following: Immunization Registry Reporting; Syndromic Surveillance Reporting, Electronic Case Reporting; Public Health Registry Reporting; and Clinical Data Registry Reporting. In addition, we proposed exclusion criteria for each of these measures.
Finally, we solicited comment on a potential new measure Health Information Exchange Across the Care Continuum under the Health Information Exchange objective in which a MIPS eligible clinician would send an electronic summary of care record, or receive and incorporate an electronic summary of care record, for transitions of care and referrals with a health care provider other than a MIPS eligible clinician. The measure would include health care providers in care settings including but not limited to long term care facilities and post-acute care providers such as skilled nursing facilities, home health, and behavioral health settings.
As we stated in the proposed rule (83 FR 35921) we understand from previous listening sessions that EHR vendors and developers will need time to develop, test and implement new measures, and MIPS eligible clinicians will need time to implement as well as establish and test their processes and workflows. As indicated above and in the discussion of the proposed scoring methodology in section III.H.3.h.(5)(d) of the proposed rule, we proposed three new measures (Query of PDMP, Verify Opioid Treatment Agreement, and Support Electronic Referral Loops by Receiving and Incorporating Health Information). We proposed that the Query of PDMP and Verify Opioid Treatment Agreement measures would be optional for the performance period in 2019 and bonus points may be earned for reporting on them. We proposed that the Support Electronic Referral Loops by Receiving and Incorporating Health Information would be required beginning with the performance period in 2019 with exclusions available. We proposed to require the Query of PDMP and Verify Opioid Treatment Agreement measures beginning with the performance period in 2020, and we solicited public comment on this proposal.
We noted that the proposals under the Health Information Exchange objective require only consolidation of existing workflows and actions, while certification criteria and standards remain the same as in the CY 2018 Quality Payment Program final rule (82 FR 53677 through 53678). Therefore, we stated our belief that MIPS eligible clinicians could potentially implement this new measure for the performance period in 2019.
The following is a summary of the comments we received on our proposals.
In the CY 2019 PFS proposed rule (83 FR 35921 through 35925), we proposed two new measures under the e-Prescribing objective. In the CY 2017 Quality Payment Program final rule, we stated that MIPS eligible clinicians will have the option to include or not include controlled substances in the definition of “permissible prescriptions” at their discretion where feasible and allowable by law in the jurisdiction where they provide care (81 FR 77227). We believe it is important to consider other requirements specific to electronic prescribing of controlled substances for health care providers to take into account and how this may interact with the proposals under this rulemaking. We are committed to combatting the opioid epidemic by making it a top priority for the agency and aligning its efforts with the HHS opioid initiative to combat misuse and promote programs that support treatment and recovery support services.
We proposed to add two new measures to the e-Prescribing objective that are based on electronic prescriptions for controlled substances (EPCS): Query of PDMP; and Verify Opioid Treatment Agreement. These measures build upon the meaningful use of CEHRT as well as the security of electronic prescribing of Schedule II controlled substances while preventing diversion. For both measures, we proposed to define opioids as Schedule II controlled substances under 21 CFR 1308.12, as they are recognized as having a high potential for abuse with potential for severe psychological or physical dependence. We also proposed to apply the same policies for the existing e-Prescribing measure to both the Query of PDMP and Verify Opioid Treatment Agreement measures, including the requirement to use CEHRT as the sole means of creating the prescription and for transmission to the pharmacy. We stated that MIPS eligible clinicians have the option to include or exclude controlled substances in the e-Prescribing measure denominator as long as they are treated uniformly across patients and all available schedules and in accordance with applicable law. However, because the intent of these two new measures is to improve prescribing practices for controlled substances, MIPS eligible clinicians would have to include Schedule II opioid prescriptions in the numerator and denominator or claim the applicable exclusion. Additionally, we noted the intent of the proposed measures is not to dissuade the prescribing or use of opioids for patients with medical diagnoses or conditions that benefit from their use, such as patients diagnosed with cancer or those receiving hospice. We solicited comment on the impact that implementing this measure could have on patients who receive opioids due to medical diagnoses such as cancer or receiving hospice care as well as treatment of patients under a program involving substance abuse education, treatment, or prevention under 42 CFR part 2.
Additionally, we solicited comment on the federal and state statutory and regulatory requirements that may impact implementation of the Query of PDMP and Verify Opioid Treatment Agreement measures.
We stated that in the event we finalize the new scoring methodology that we proposed in section III.H.3.h.(5)(d) of the proposed rule, MIPS eligible clinicians who claim the exclusion under the existing e-Prescribing measure would automatically receive an exclusion for all three of the measures under the e-Prescribing objective; they would not have to also claim exclusions for the other two measures, Query of PDMP and Verify Opioid Treatment Agreement. We are not finalizing this proposal because we are finalizing the two new measures (Query of PDMP and Verify Opioid Treatment Agreement) are optional, so exclusions would not be necessary for them.
As we stated in the proposed rule (83 FR 35922 through 35923), a PDMP is an electronic database that tracks prescriptions of controlled substances at the State level. PDMPs play an important role in patient safety by assisting in the identification of patients who have multiple prescriptions for controlled substances or may be misusing or overusing them. Querying the PDMP is important for tracking the prescribed controlled substances and improving prescribing practices. The ONC, Centers for Disease Control and Prevention (CDC), Department of Justice (DOJ) and Substance Abuse and Mental Health Services Administration (SAMHSA) have had integral roles in the integration and expansion of PMDPs with health information technology systems. For example, the ONC and SAMHSA collaboratively led the “Enhancing Access” project to improve health care provider access to PDMP data utilizing health IT.
We stated that we recognize both the utility and value of addressing PDMP EHR integration and further recognizes the majority of states mandate use of State prescription monitoring programs (PMPs) requiring prescribers/dispensers to access PMP.
We proposed that the query of the PDMP for prescription drug history must be conducted prior to the electronic transmission of the Schedule II opioid prescription. MIPS eligible clinicians would have flexibility to query the PDMP using CEHRT in any manner allowed under their State law.
Although the query of the PDMP may currently be burdensome for some MIPS eligible clinicians as part of their current workflow practice, we stated our belief that querying the PDMP is beneficial to optimal prescribing practices and foresee progression toward fully automated queries of the PDMP building upon the current initiatives at the State level.
We proposed to include in this measure all permissible prescriptions and dispensing of Schedule II opioids regardless of the amount prescribed during an encounter in order for MIPS
We noted that we also understand that PDMP integration is not currently in widespread use for CEHRT, and many MIPS eligible clinicians may require additional time and workflow changes at the point of care before they can meet this measure without experiencing significant burden. For instance, many MIPS eligible clinicians will likely need to manually enter the data into CEHRT to document the completion of the query of the PDMP action. In addition, some MIPS eligible clinicians may also need to conduct manual calculation of the measure. Even for those MIPS eligible clinicians that have achieved successful integration of a PDMP with their EHR, this measure may not be machine calculable, for instance, in cases where the MIPS eligible clinician follows a link within the EHR to a separate PDMP system. For the purposes of meeting this measure, we noted there is no existing certification criteria for the query of a PDMP. However, we stated our belief that the use of structured data captured in the CEHRT can support querying a PDMP through the broader use of health IT. We solicited public comment on whether ONC should consider adopting standards and certification criteria to support the query of a PDMP, and if such criteria were to be adopted, on what timeline should CMS require their use to meet this measure.
We noted the NCPDP SCRIPT 2017071 standard for e-prescribing is now available and can help to support PDMP and EHR integration. We solicited public comment, especially from health care providers and health IT developers on whether they believe use of this standard can support MIPS eligible clinicians seeking to report on this measure, and whether HHS should encourage use of this standard through separate rulemaking.
We solicited comment on the challenges associated with querying the PDMP with and without CEHRT integration and whether this proposed measure should require certain standards, methods or functionalities to minimize burden.
In including EPCS as a component of the measure as proposed, we acknowledged and sought input on perceived and real technological barriers as part of its effective implementation including but not limited to input on two-factor authentication and on the effective and appropriate uses of technology, including the use of telehealth modalities to support established patient and health care provider relationships subsequent to in-person visit(s) and for prescribing purposes.
We also proposed that in order to meet this measure, a MIPS eligible clinician must use the capabilities and standards as defined for CEHRT at 45 CFR 170.315(a)(10)(ii) and (b)(3).
The following is a summary of the comments we received on these proposals.
Other commenters stated that while PDMPs play an important role in identifying high-risk patients, and recommended that CMS move more slowly with requiring the measure until PDMPs are more fully integrated into EHRs and clinician workflows.
The certification criteria defined at § 170.315(b)(3) supports this measure because it allows a MIPS eligible clinician to create a new prescription, change a prescription, cancel a prescription, refill a prescription, request fill status notifications and request and receive medication history information to and from pharmacies. PDMPs collect, monitor, and analyze electronically transmitted prescribing and dispensing data submitted by pharmacies and dispensing practitioners. Additionally, the CEHRT criteria defined at § 170.315(a)(10)(ii) defines drug formulary checks, which
We are aware of the need for additional time to implement this measure and thus we are making it optional in CY 2019 and will propose our policy for this measure for CY 2020 in future rulemaking.
We will continue to work with ONC and other stakeholders to encourage the development of standards, which facilitate increased interoperability between PDMPs and other systems, including HIEs and clinician health IT systems.
After consideration of the comments we received, we are finalizing the Query of PDMP measure with modification:
For the purposes of this measure, we are defining opioids as Schedule II controlled substances under 21 CFR 1308.12. We are finalizing the proposal to apply the same policies for the existing e-Prescribing measure to the Query of PDMP measure, including the requirement to use CEHRT as the sole means of creating the prescription and for transmission to the pharmacy. The query of the PDMP for prescription drug history must be conducted prior to the electronic transmission of the Schedule II opioid prescription. MIPS eligible clinicians would have flexibility to query the PDMP using CEHRT in any manner allowed under their State law. This measure includes all permissible prescriptions and dispensing of Schedule II opioids regardless of the amount prescribed during an encounter in order for MIPS eligible clinicians to identify multiple health care provider episodes (physician shopping), prescriptions of dangerous combinations of drugs, prescribing rates and controlled substances prescribed in high quantities. To meet this measure, a MIPS eligible clinician must use the capabilities and standards as defined for CEHRT at §§ 170.315(a)(10)(ii) and (b)(3).
As this measure is optional in CY 2019, we are not finalizing exclusions for it. We will propose our policy for the Query of a PDMP measure for CY 2020 in future rulemaking.
As we stated in the proposed rule at 83 FR 35923, the intent of this measure is for MIPS eligible clinicians to identify whether there is an existing opioid treatment agreement when they electronically prescribe a Schedule II opioid using CEHRT if the total duration of the patient's Schedule II opioid prescriptions is at least 30 cumulative days. We stated that we believe seeking to identify an opioid treatment agreement will further efforts to coordinate care between health care providers and foster a more informed review of patient therapy. The intent of the treatment agreement is to clearly outline the responsibilities of both patient and MIPS eligible clinician in the treatment plan. Such a treatment plan can be integrated into care coordination and care plan activities
We stated that we understand from stakeholder feedback during listening sessions that there are varied opinions regarding opioid treatment agreements amongst health care providers. Some are supportive of their use, indicating that treatment agreements are an important part of the prescription of opioids for pain management, and help patients understand their role and responsibilities for maintaining compliance with terms of the treatment. Other health care providers object to their use citing ethical concerns, and creation of division and trust issues in the health care provider-patient relationship. Other concerns stem from possible disconnect between the language and terminology used in the agreement and the level of comprehension on the part of the patient. Because of the debate among practitioners, we requested comment on the challenges this proposed measure may create for MIPS eligible clinicians, how those challenges might be mitigated, and whether this measure should be included as part of the Promoting Interoperability performance category. We also acknowledged challenges related to prescribing practices and multiple State laws which may present barriers to the uniform implementation of this proposed measure. We solicited public comment on the challenges and concerns associated with opioid treatment agreements and how they could impact the feasibility of the proposal.
We proposed this measure would include all Schedule II opioids prescribed for a patient electronically using CEHRT by the MIPS eligible clinician during the performance period, as well as any Schedule II opioid prescriptions identified in the patient's medication history request and response transactions during a 6-month look-back period, where the total number of days for which a Schedule II opioid was prescribed for the patient is at least 30 days.
We stated that there also may be MIPS eligible clinician burdens specific to identifying the existence of a treatment agreement which could require additional time and changes to existing workflows, determining what constitutes a treatment agreement due to a lack of a definition, standard or electronic format and manual calculation of the measure. We note that there is no certified capability specific to verification and incorporation of an opioid treatment agreement, however, clinicians must use the capabilities and standards defined for CEHRT at §§ 170.315(a)(10) and (b)(3) and 170.205(b)(2) to meet the measure. In addition, limitations in the completeness of care team information may limit the ability of a MIPS eligible clinician to identify all potential sources for querying and obtaining information on a treatment agreement for a specific patient. There are currently pilots in development focused on increasing connectivity and data exchange among health care providers to better integrate behavioral health information, for instance, pilots taking place as part of the federal Demonstration Program for Certified Community Behavioral Health Clinics (CCBHC)
We proposed the 6-month look-back period would begin on the date on which the MIPS eligible clinician electronically transmits their Schedule II opioid prescription using CEHRT and provided an illustrative example of this policy in the proposed rule.
We proposed a 6-month look-back period to identify more egregious cases of potential overutilization of opioids and to cover timeframes for use outside the performance period. In addition, we proposed that the 6-month look-back period would utilize at a minimum the industry standard NCDCP SCRIPT v10.6 medication history request and response transactions codified at § 170.205(b)(2)). As ONC has stated (80 FR 62642), adoption of the requirements for NCDCP SCRIPT v10.6 does not preclude developers from incorporating and using technology standards or services not required by regulation in their health IT products.
We did not propose to define an opioid treatment agreement as a standardized electronic document; nor did we propose to define the data elements, content structure, or clinical purpose for a specific document to be considered a “treatment agreement.” For this measure, we solicited comment on what characteristics should be part of an opioid treatment agreement including data, content and clinical purpose into CEHRT, including which functionalities could be utilized to accomplish this. We noted that a variety of standards available in CEHRT might support the electronic exchange of opioid abuse related treatment data, such as use of the Consolidated Clinical Document Architecture (C-CDA) care plan template that is currently optional in CEHRT.
We also solicited comment on methods or processes for incorporation of the treatment agreement into CEHRT, including which functionalities could be utilized to accomplish this task.
We solicited comment on whether there are specific data elements that are currently standardized that should be incorporated via reconciliation and if the “patient health data capture” functionality (§ 170.315(e)(3)) could be used to incorporate a treatment plan that is not a structured document with structured data elements.
We proposed that the exclusion criteria would be limited to prescriptions of Schedule II opioids as the measure action is limited to electronic prescriptions of Schedule II opioids only and does not include any other types of electronic prescriptions.
We requested comment on the proposed exclusion criteria and whether there are additional circumstances that should be added to the exclusion criteria and what those circumstances might be including medical diagnoses such as cancer or patients under care of hospice.
We solicited comment on whether these types of agreements could create a burden on clinicians and patients, particularly clinicians who serve patients with cancer or those practicing in hospice, as well as the patients they serve.
We also proposed that, in order to meet this measure, a MIPS eligible clinician must use the capabilities and standards as defined for CEHRT at §§ 170.315(a)(10) and (b)(3) and 170.205(b)(2).
As discussed earlier, we recognize that many health care providers are only beginning to adopt electronic prescriptions for controlled substances (EPCS) at this time. Although we have proposed two new measures which combine EPCS with other actions, we requested comment on whether stakeholders would be interested in a measure focused only on the number of Schedule II opioids prescribed and the successful use of EPCS for permissible prescriptions electronically prescribed.
We solicited comment about the feasibility of such a measure, and whether stakeholders believe this would help to encourage broader adoption of EPCS.
The following is a summary of the comments we received on these proposals.
As discussed in the proposed rule, we believe there are some ways in which certified health IT may be able to support the electronic exchange of opioid related treatment data, such as use of the C-CDA care plan template that is currently optional in CEHRT. This template contains information on health concerns, goals, interventions, health status evaluation & outcomes sections that could support the development of an opioid treatment agreement. In addition, the “patient health data capture” functionality which is part of the 2015 Edition certification criteria (§ 170.315(e)(3)) could be used to incorporate a treatment plan that is not a structured document with structured data elements.
We note that there is no capability within certified health IT to support verification of an opioid treatment agreement. We stated (83 FR 35925) that in order to meet the measure, MIPS eligible clinicians must use the capabilities and standards defined for CEHRT at §§ 170.315(a)(10) and (b)(3) and 170.205(b)(2). The certification criteria defined at § 170.315(a)(10) defines drug formulary checks and preferred drug check lists for a given patient and medication, which are the most useful when utilized with e-Prescribing. These criteria may enable health IT to provide structured data to support querying and may increase the efficiency and safety of opioid prescribing, while potentially reducing the cost of care and confronting the opioid crisis.
The certification criteria defined at § 170.315(b)(3) supports this measure because it allows a health care provider to create a new prescription, change a prescription, cancel a prescription, refill a prescription, request fill status notifications and request and receive medication history information. Additionally, certification criteria defined at § 170.205(b)(2) adopts the NCPDP SCRIPT Standard v10.6 standards and associated implementation specifications for electronic prescribing.
While we understand the above regulations do not specifically define certification criteria and standards for the Verify Opioid Treatment Agreement measure, we believe they may help provide a framework for MIPS eligible clinicians who would like to implement the measure.
In addition, a commenter stated the measure is highly problematic and prone to error calculation because the denominator is based on patients who are receiving an electronic prescription for a Schedule II opioid medication and have a total of 30 or more cumulative prescription days on the Schedule II opioid being prescribed in a 6-month look back period. The commenter stated that neither the NCPDP 10.6 Medication History Query nor the NCPDP 2017071 Medication History Query has a required, discrete data field to capture the prescription days. The commenter requested CMS not finalize the measure and not proceed with making the measure optional until it can be better defined. The commenter also stated that if the measure is finalized, that CMS should change its denominator proposal to be based on doses prescribed, as opposed to prescription days.
In addition, as opioid treatment agreements become more widely adopted, we believe this measure may help to encourage health IT vendors to develop innovative solutions to capture data and reduce workflow complexities.
We decline to change the numerator to those patients for whom the MIPS eligible clinician has a signed opioid treatment agreement in CEHRT. The goal of this measure is to encourage MIPS eligible clinicians to seek to identify an existing opioid treatment agreement for those patients for whom they have prescribed Schedule II opioids, rather than those patients for whom they have successfully identified and incorporated an opioid treatment agreement.
We understand these concerns and believe additional time is necessary to implement this measure before we make it required. Therefore, we are aligning with the Medicare Promoting Interoperability Program for eligible hospitals and CAHs and making the Verify Opioid Treatment Agreement measure optional for the 2019 and 2020 MIPS performance periods. We will include proposals for this measure for future years in future rulemaking.
Because we are finalizing the measure as optional for both the 2019 and 2020 performance periods, we decline to offer any additional exclusions for this measure.
After consideration of the comments received, we are adopting our proposal for the addition of the Verify Opioid Treatment Agreement measure with modification:
We define opioids as Schedule II controlled substances under 21 CFR 1308.12. We are finalizing the proposal to apply the same policies for the existing e-Prescribing measure to the Verify Opioid Treatment Agreement measure, including the requirement to use CEHRT as the sole means of creating the prescription and for transmission to the pharmacy. This measure includes all Schedule II opioids prescribed for a patient electronically using CEHRT by the MIPS eligible clinician during the performance period, as well as any Schedule II opioid prescriptions identified in the patient's medication history request and response transactions during a 6-month look-back period, where the total number of days for which a Schedule II opioid was prescribed for the patient is at least 30 days.
The 6-month look-back period begins on the date on which the MIPS eligible clinician electronically transmits their Schedule II opioid prescription using CEHRT. The 6-month look-back period must utilize at a minimum the industry standard NCDCP SCRIPT v10.6 medication history request and response transactions codified at § 170.205(b)(2)).
To meet this measure, a MIPS eligible clinician must use the capabilities and standards as defined for CEHRT at §§ 170.315(a)(10) and (b)(3) and 170.205(b)(2).
This measure will be optional in the CY 2019 and 2020 performance periods, so we are not finalizing the proposed exclusion for CY 2020.
As we stated in the proposed rule (83 FR 35925) the Health Information Exchange measures for MIPS eligible clinicians hold particular importance because of the role they play within the care continuum. In addition, these measures encourage and leverage interoperability on a broader scale and promote health IT-based care coordination. However, through our review of the existing measures, we determined that we could potentially improve the measures to further reduce burden and better focus the measures on interoperability in health care provider to health care provider exchange. Such modifications would address a number of concerns raised by stakeholders including:
• Supporting the implementation of effective health IT supported workflows based on a specific organization's needs;
• Reducing complexity and burden associated with the manual tracking of workflows to support health IT measures; and
• Emphasizing within these measures the importance of using health IT to support closing the referral loop to improve care coordination.
We stated that we believe we can potentially improve the existing Health Information Exchange measures to streamline measurement, remove redundancy, reduce complexity and burden, and address stakeholders' concerns about the focus and impact of the measures on the interoperable use of health IT.
In the CY 2019 PFS proposed rule (83 FR 35925 through 35928), we proposed several changes to the current measures under the Health Information Exchange objective. First, we proposed to change the name of the Send a Summary of Care measure to Support Electronic Referral Loops by Sending Health Information. We also proposed to remove the Clinical Information Reconciliation measure and combine it with the Request/Accept Summary of Care measure to create a new measure, Support Electronic Referral Loops by Receiving and Incorporating Health Information. This proposed new measure would include actions from both the Request/Accept Summary of Care measure and Clinical Information Reconciliation measure.
We proposed to change the name of the Send a Summary of Care measure to Support Electronic Referral Loops by Sending Health Information measure (83 FR 35925 through 35926), to better reflect the emphasis on completing the referral loop and improving care coordination.
Through public comment and stakeholder correspondence, we have become aware that in the health care industry there is some misunderstanding of the scope of transitions and referrals which must be included in the denominator of this measure. In the event that a MIPS eligible clinician is the recipient of a transition of care or referral, and subsequent to providing care the MIPS eligible clinician transitions or refers the patient back to the referring provider of care, this transition of care should be included in the denominator of the measure for the MIPS eligible clinician. We expect this will help build upon the current provider to provider communication via electronic exchange of summary of care records created by CEHRT required under this measure, further promote interoperability and care coordination with additional health care providers, and prevent redundancy in creation of a separate measure.
In the past, stakeholders have raised concerns that the summary care records shared according to the C-CDA standard included excessive information not relevant to immediate care needs, which increased burden on health care providers. Under the ONC Health IT Certification Program 2015 Edition, CEHRT must have the capability to exchange all of the information in the CCDS as part of a summary care record structured according to the C-CDA standard. We previously finalized in the final rule titled “Medicare and Medicaid Programs Electronic Health Record Incentive Program—Stage 2: Health Information Technology, Standards Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology” (hereafter referred to as the “Stage 2 final rule”) (77 FR 53991 through 53993) that health care providers must transmit all of the CCDS information as part of this summary care record, if known, and that health care providers must always transmit information about the problem list, medications, and medication allergies, or validate that this information is not known.
As finalized in the final rule titled “Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Stage 3 and Modifications to Meaningful Use in 2015 Through 2017; Final Rule” (hereafter referred to as the “2015 EHR Incentive Programs final rule”) (80 FR 62852 through 62861), our policy allows health care providers to constrain the information in the summary care record to support transitions of care. For instance, we encouraged health care providers to send a list of items that he or she believes to be pertinent and relevant to the patient's care, rather than a list of all problems, whether active or resolved, that have ever populated the problem list. Although a current problem list must always be included, the health care provider can use his or her judgment in deciding which items historically present on the problem list, medical history list (if it exists in CEHRT), or surgical history list are relevant given the clinical circumstances.
We also wish to encourage MIPS eligible clinicians to use the document template available within the C-CDA which contains the most clinically relevant information required by the receiver. Accordingly, we proposed that MIPS eligible clinicians may use any document template within the C-CDA standard for purposes of the measures under the Health Information Exchange objective. Although a MIPS eligible clinician's CEHRT must be capable of sending the full C-CDA upon request, we believe this additional flexibility will help support clinicians' efforts to ensure the information supporting a transition is relevant.
For instance, when the MIPS eligible clinician is referring to another health care provider the recommended document is the “Referral Note” which is designed to communicate pertinent information from a MIPS eligible clinician who is requesting services of another health care provider of clinical or non-clinical services. When the receiving health care provider sends back the information, the most relevant C-CDA document template may be the “Consultation Note,” which is generated by a request from a clinician for an opinion or advice from another clinician. Although the 2015 Edition transition of care certification criterion only requires testing to the Continuity of Care Document and Referral Note document templates, we proposed to allow MIPS eligible clinicians the flexibility to use additional C-CDA templates most appropriate to their clinical workflows. Clinicians would need to work with their health IT developer to determine appropriate technical workflows and implementation. For more information about the C-CDA and associated templates, see
The following is a summary of the comments we received on these proposals.
While MIPS eligible clinicians' CEHRT must be capable of sending the full C-CDA upon request, we believe this additional flexibility to utilize different functionality within the C-CDA will help support clinicians efforts to ensure the information supporting a transition is relevant. We note that in the use of a document template the clinician would need to work with their developer to determine appropriate technical workflows and implementation.
After consideration of the comments received, we are finalizing the proposal to change the name of the Send a Summary of Care measure to Support Electronic Referral Loops by Sending Health Information measure. We are also finalizing the proposal that MIPS eligible clinicians may use any document template within the C-CDA standard for purposes of the measures under the Health Information Exchange objective.
We proposed to remove the Request/Accept Summary of Care measure (83 FR 35926) based on our analysis of the existing measure and in response to stakeholder input.
We stated that, through review of implementation practices based on stakeholder feedback, we believe that the existing Request/Accept Summary of Care measure is not feasible for machine calculation in the majority of cases. The intent of the measure is to identify when MIPS eligible clinicians are engaging with other providers of
(1) A burdensome workflow to document the manual action to request or obtain an electronic record, for example, clicking a check box to document each phone call or similar manual administrative task, or
(2) A workflow which is limited to only querying internal resources for the existence of an electronic document.
Neither of these two implementation options is desirable when the intent of the measure is to incentivize and encourage health care providers to implement effective workflows to identify, receive, and incorporate patient health information from other health care providers into the patient record.
In addition, our analysis identified that the definition of incorporate within the Request/Accept Summary of Care measure is insufficient to ensure an interoperable result. When this measure was initially finalized in the 2015 EHR Incentive Programs final rule at 80 FR 62860, we did not define “incorporate” as we believed it would vary amongst health care provider's workflows, patient population and the referring health care provider. In addition, we noted that the information could be included as an attachment, as a link within the EHR, as imported structured data or reconciled within the record and not exclusively performed through use of CEHRT. Further, stakeholder feedback highlights the fact that the requirement to incorporate data is insufficiently clear regarding what data must be incorporated.
Our intention was that “incorporate” would relate to the workflows undertaken in the process of clinical information reconciliation further defined in the Clinical Information Reconciliation measure (80 FR 62852 through 62862). Taken together, the three measures under the Health Information Exchange objective were intended to support the referral loop through sending, receiving, and incorporating patient health data into the patient record. However, stakeholder feedback on the measures suggests that the separation between receiving and reconciling patient health information is not reflective of clinical and care coordination workflows. Further, stakeholders noted, that when approached separately, the incorporate portion of the Request/Accept Summary of Care measure is both inconsistent with and redundant to the Clinical Information Reconciliation measure which causes unnecessary burden and duplicative measure calculation.
The following is a summary of the comments we received on these proposals.
After consideration of the comments received, we are removing the Request/Accept Summary of Care Measure as proposed.
We proposed to remove the Clinical Information Reconciliation measure (83 FR 35927) to reduce redundancy, complexity, and MIPS eligible clinician burden.
We stated that we believe the Clinical Information Reconciliation measure is redundant in regard to the requirement to “incorporate” electronic summaries of care in light of the requirements of the Request/Accept Summary of Care measure. In addition, the measure is not fully health IT based as the exchange of health care information is not required to complete the measure action and the measure specification is not limited to only the reconciliation of electronic information in health IT supported workflows. We stated in the 2015 EHR Incentive Programs final rule at 80 FR 62861 that the clinical information reconciliation process could involve both automated and manual reconciliation to allow the receiving health care provider to work with both electronic data received as well as the patient to reconcile their health information. Further, stakeholder feedback from hospitals, clinicians, and health IT developers indicates that because the measure is not fully based on the use of health IT to meet the measurement requirements, health care providers must engage in burdensome tracking of manual workflows. While the overall activity of clinical information reconciliation supports quality patient care and should be a part of effective clinical workflows, the process to record and track each individual action places unnecessary burden on MIPS eligible clinicians.
The following is a summary of the comments we received on these proposals.
After consideration of the comments received, we are removing the Clinical Information Reconciliation measure as proposed.
We proposed to add the following new measure for inclusion in the Health Information Exchange objective: Support Electronic Referral Loops by Receiving and Incorporating Health Information (FR 83 35927). This measure would build upon and replace the existing Request/Accept Summary of Care and Clinical Information Reconciliation measures.
We proposed to combine two existing measures, the Request/Accept Summary of Care measure and the Clinical Information Reconciliation measure, in this new Support Electronic Referral Loops by Receiving and Incorporating Health Information measure to focus on the exchange of health care information as the current Clinical Information Reconciliation measure is not reliant on the exchange of health care information to complete the measure action. We did not propose to change the actions associated with the existing measures; rather, we proposed to combine the two measures to focus on the exchange of the health care information, reduce administrative burden, and streamline and simplify reporting.
CMS and ONC worked together to define the following for this measure:
We note that these two exclusions for the measure were proposed in different sections of the proposed rule (83 FR 35916, 35927).
We requested comment on the proposed exclusion criteria and whether there are additional circumstances that should be added to the exclusion criteria and what those circumstances might be.
For the proposed measure, the denominator would increment on the receipt of an electronic summary of care record after the MIPS eligible clinician engages in workflows to obtain an electronic summary of care record for a transition, referral or patient encounter in which the MIPS eligible clinician has never before encountered the patient. The numerator would increment upon completion of clinical information reconciliation of the electronic summary of care record for medications, medication allergies, and current problems. The MIPS eligible clinician would no longer be required to manually count each individual non-health-IT-related action taken to engage with other providers of care and care team members to identify and obtain the electronic summary of care record. Instead, the proposed measure would focus on the result of these actions when an electronic summary of care record is successfully identified, received, and reconciled with the patient record. We stated that we believe this approach would allow MIPS eligible clinicians to determine and implement appropriate workflows supporting efforts to receive the electronic summary of care record consistent with the implementation of effective health IT information exchange at an organizational level.
Finally, we proposed to apply our existing policy for cases in which the MIPS eligible clinician determines no update or modification is necessary within the patient record based on the electronic clinical information received, and the MIPS eligible clinician may count the reconciliation in the numerator without completing a redundant or duplicate update to the record. We welcomed public comment on methods by which this specific action could potentially be electronically measured by the MIPS eligible clinician's health IT system—such as incrementing on electronic signature or approval by an authorized health care provider—to mitigate the risk of burden associated with manual tracking of the action, such as having to click check boxes.
We welcomed public comment on these proposals. We solicited comment on methods and approaches to quantify the reduction in burden for MIPS eligible clinicians implementing streamlined workflows for this proposed health IT-based measure. We also solicited comment on the impact these proposed modifications may have for health IT developers in updating, testing, and implementing new measure calculations related to these proposed changes. Specifically, we solicited comment on whether ONC should require developers to recertify their EHR technology as a result of the changes proposed, or whether they should be able to make the changes and engage in testing without recertification, and on the appropriate timeline for such requirements factoring in the proposed continuous 90 day performance period within the calendar year for clinicians. Finally, we solicited comment on whether this proposed new measure that combines the Request/Accept Summary of Care and Clinical Information Reconciliation measures should be adopted, or whether either or both of the existing Request/Accept Summary of Care and Clinical Information Reconciliation measures should be retained in lieu of this proposed new measure.
We stated that in the event we finalize the new scoring methodology we proposed in section III.H.3.h.(5)(d) of the proposed rule, an exclusion would be available for MIPS eligible clinicians who cannot implement the Support Electronic Referral Loops by Receiving and Incorporating Health Information measure for a performance period in CY 2019 and an exclusion for MIPS eligible clinician who receives fewer than 100 transitions of care or referrals or has fewer than 100 encounters with patients never before encountered during the performance period.
We also proposed that, in order to meet this measure, a MIPS eligible clinician must use the capabilities and standards as defined for CEHRT at § 170.315(b)(1) and (2).
We solicited comment on these proposals and our summary and response are below.
After consideration of the public comments we received, we are finalizing the Support Electronic Referral Loops by Receiving and Incorporating Health Information measure as proposed. We are finalizing the proposal to apply the existing policy for cases in which the MIPS eligible clinician determines no update or modification is necessary within the patient record based on the electronic clinical information received, and the MIPS eligible clinician may count the reconciliation in the numerator without completing a redundant or duplicate update to the record.
We are finalizing a MIPS eligible clinician must use the capabilities and standards as defined for CEHRT at § 170.315(b)(1) and (b)(2).
We are adopting the Support Electronic Referral Loops by Receiving and Incorporating Health Information measure as follows:
•
(2) Any MIPS eligible clinician who receives fewer than 100 transitions of care or referrals or has fewer than 100 encounters with patients never before encountered during the performance period.
The Provider to Patient Exchange objective for MIPS eligible clinicians builds upon the goal of improved access and exchange of patient data, patient centered communication and coordination of care using CEHRT. We proposed a new scoring methodology in section III.H.3.h.(5)(d) of the proposed rule, under which we proposed to rename the Patient Electronic Access objective to Provider to Patient Exchange, remove the Patient-Specific Education measure and rename the Provide Patient Access measure to Provide Patients Electronic Access to Their Health Information. In addition, we proposed to remove the Coordination of Care through Patient Engagement objective and all associated measures. The existing Promoting Interoperability performance category Patient Electronic Access objective includes two measures and the existing Coordination of Care through Patient Engagement objective includes three measures.
We reviewed the Promoting Interoperability performance category requirements and determined that these proposals could reduce program complexity and burden and better focus on leveraging the most current health IT functions and standards for patient flexibility of access and exchange of information.
In the CY 2019 PFS proposed rule (83 FR 35928 through 35929), we proposed the Provider to Patient Exchange objective would include one measure, the existing Provide Patient Access measure, which we proposed to rename to Provide Patients Electronic Access to Their Health Information.
We proposed to change the name of the Provide Patient Access measure to Provide Patients Electronic Access to Their Health Information measure (83 FR 35928) to better reflect the emphasis on patient engagement in their health care and patient's electronic access of their health information through use of APIs.
We proposed to change the measure name to emphasize electronic access of patient health information as opposed to use of paper-based actions and limit the focus to only health IT solutions to encourage adoption and innovation in use of CEHRT (80 FR 62783 through 62784). In addition, we are committed to promoting patient engagement with their healthcare information and ensuring access in an electronic format.
We solicited comment on these proposals and our summary and response are below.
We appreciate commenters' interest in additional educational materials for patients on how they can improve the privacy and security of their health information. We will take this comment into consideration as we consider what other consumer-facing materials are helpful, and we direct commenters to resources currently available from HHS (for example, content and materials such as those available at
After consideration of the comments we received, we finalizing the new name, Provide Patients Electronic Access to Their Health Information, as proposed.
We proposed to remove the Patient-Generated Health Data (PGHD) measure (83 FR 35928) to reduce complexity and focus on the goal of using advanced EHR technology and functionalities to advance interoperability and health information exchange.
As finalized in the 2015 EHR Incentive Programs final rule at 80 FR 62851, the measure is not fully health IT based as we did not specify the manner in which health care providers would incorporate the data received. Instead, we finalized that health care providers could work with their EHR developers to establish the methods and processes that work best for their practice and needs. We indicated that this could include incorporation of the information using a structured format (such as an existing field in the EHR or maintaining an isolation between the data and the patient record such as incorporation as an attachment, link or text reference which would not require the advanced use of CEHRT). Although we continue to believe that incorporating this data is valuable, we prioritized only those actions which are completed electronically using certified health IT.
We solicited comment on these proposals and our summary and response are below.
After consideration of the public comments we received, we are removing the Patient-Generated Health Data measure as proposed.
We proposed to remove the Patient-Specific Education measure (83 FR 35928) as it has proven burdensome to MIPS eligible clinicians in ways that were unintended and detracts from their progress on current program priorities.
The Patient-Specific Education measure was finalized as a performance score measure for MIPS eligible clinicians in the CY 2017 Quality Payment Program final rule with the intent of improving patient health, increasing transparency and engaging patients in their care (81 FR 77228 through 77237).
We stated that we believe that the Patient-Specific Education measure does not align with the current emphasis of the Promoting Interoperability performance category to increase interoperability, or reduce burden for MIPS eligible clinicians. In addition to not including interoperability as a core focus, stakeholders have indicated that this measure does not capture many of the innovative activities around providing patient education, for instance new approaches to integrating patient education within clinical decision support modules. As a result of this lack of alignment, this measure could potentially increase clinician burden.
We solicited comment on this proposal and our summary and response are below.
After consideration of the public comments we received, we are removing of the Patient-Specific Education measure as proposed.
We proposed to remove the Secure Messaging measure (82 FR 35929) as it has proven burdensome to MIPS eligible clinicians in ways that were unintended and detracts from MIPS eligible clinicians' progress on current program priorities.
The Secure Messaging measure was finalized in the CY 2017 Quality Payment Program final rule with the intent to build upon the policy goals of Stage 2 under the EHR Incentive Programs of using CEHRT for health care provider-patient communication (81 FR 77227 through 77236). We stated that we believe that the Secure Messaging measure does not align with the current emphasis of the Promoting Interoperability performance category to increase interoperability or reduce burden for MIPS eligible clinicians. In addition, we stated that we believe there is burden associated with tracking secure messages, including the unintended consequences of workflows designed for the measure rather than for clinical and administrative effectiveness.
We solicited comment on this proposal and our summary and response are below.
After consideration of the public comments we received, we are removing the Secure Messaging measure as proposed.
We proposed to remove the View, Download or Transmit measure (83 FR 35929) as it has proven burdensome to MIPS eligible clinicians in ways that were unintended and detracts from their progress on current program priorities.
We stated that we have received MIPS eligible clinician and stakeholder feedback through correspondence, public forums, and listening sessions indicating there is ongoing concern with measures which require patient action for successful submission. We have noted that data analysis on the patient action measures supports stakeholder concerns that barriers exist which impact a clinician's ability to meet them. Stakeholders have indicated that successful submission of the measure is reliant upon the patient, who may face barriers to access which are outside a clinician's control.
After additional review, we noted that successful performance predicated solely on a patient's action has inadvertently created burdens to MIPS eligible clinicians and detracts from progress on Promoting Interoperability measure goals of focusing on patient care, interoperability and leveraging advanced used of health IT. Therefore, we proposed to remove the View, Download or Transmit measure.
We solicited comment on this proposal and our summary and response are below.
After consideration of the public comments we received, we are removing the View, Download or Transmit measure as proposed.
In summary, we are removing the Coordination of Care Through Patient Engagement objective and its associated measures: View, Download or Transmit; Secure Messaging; and Patient-Generated Health Data. We are renaming the Patient Electronic Access objective to Provider to Patient Exchange objective and removing the Patient-Specific Education measure. We are renaming the Provide Patient Access
In connection with the scoring methodology proposed in section III.H.3.h.(5)(d) of the proposed rule, in the CY 2019 PFS proposed rule (83 FR 35929 through 35931), we proposed changes to the Public Health and Clinical Data Registry Reporting objective and five associated measures.
We stated that we believe that public health reporting through EHRs will extend the use of electronic reporting solutions to additional events and care processes, increase timeliness and efficiency of reporting and replace manual data entry.
We proposed to change the name of the objective to Public Health and Clinical Data Exchange and proposed exclusions for each of the associated measures.
Under the new scoring methodology proposed in section III.H.3.h.(5)(d) of the proposed rule, we proposed that a MIPS eligible clinician would be required to submit two of the measures of the clinician's choice from the five measures associated with the objective: Immunization Registry Reporting, Syndromic Surveillance Reporting, Electronic Case Reporting, Public Health Registry Reporting, and Clinical Data Registry Reporting.
In prior rulemaking, we recognized the goal of increasing interoperability through public health registry exchange of data (80 FR 62771). We stated that we continue to believe that public health reporting is valuable in terms of health information exchange between MIPS eligible clinicians and public health and clinical data registries. For example, when immunization information is directly exchanged between EHRs and registries, patient information may be accessed by all of a patient's health care providers for improved continuity of care and reduced health care provider burden, as well as supporting population health monitoring.
We also proposed exclusion criteria for each of the Public Health and Clinical Data Exchange measures beginning with the performance period in 2019. Under the scoring methodology for the Promoting Interoperability performance category for the performance period in 2018 (82 FR 53676 through 53677), the measures associated with the Public Health and Clinical Data Registry Reporting objective are not required for the base score, and thus we did not establish exclusion criteria for them. However, we understand that some MIPS eligible clinicians may not be able to report to public health agencies or clinical data registries due to their scope of practice. Therefore, we proposed the following measure exclusions based on the exclusions finalized in previous rulemaking under the EHR Incentive Programs (80 FR 62862 through 62871).
1. Does not administer any immunizations to any of the populations for which data is collected by its jurisdiction's immunization registry or immunization information system during the performance period.
2. Operates in a jurisdiction for which no immunization registry or immunization information system is capable of accepting the specific standards required to meet the CEHRT definition at the start of the performance period.
3. Operates in a jurisdiction where no immunization registry or immunization information system has declared readiness to receive immunization data as of 6 months prior to the start of the performance period.
1. Is not in a category of health care providers from which ambulatory syndromic surveillance data is collected by their jurisdiction's syndromic surveillance system.
2. Operates in a jurisdiction for which no public health agency is capable of receiving electronic syndromic surveillance data in the specific standards required to meet the CEHRT definition at the start of the performance period.
3. Operates in a jurisdiction where no public health agency has declared readiness to receive syndromic surveillance data from MIPS eligible clinicians as of 6 months prior to the start of the performance period.
1. Does not treat or diagnose any reportable diseases for which data is collected by their jurisdiction's reportable disease system during the performance period.
2. Operates in a jurisdiction for which no public health agency is capable of receiving electronic case reporting data in the specific standards required to meet the CEHRT definition at the start of the performance period.
3. Operates in a jurisdiction where no public health agency has declared readiness to receive electronic case reporting data as of 6 months prior to the start of the performance period.
1. Does not diagnose or directly treat any disease or condition associated with a public health registry in the MIPS eligible clinician's jurisdiction during the performance period.
2. Operates in a jurisdiction for which no public health agency is capable of accepting electronic registry transactions in the specific standards required to meet the CEHRT definition at the start of the performance period.
3. Operates in a jurisdiction where no public health registry for which the MIPS eligible clinician is eligible has declared readiness to receive electronic registry transactions as of 6 months prior to the start of the performance period.
1. Does not diagnose or directly treat any disease or condition associated with a clinical data registry in their jurisdiction during the performance period.
2. Operates in a jurisdiction for which no clinical data registry is capable of accepting electronic registry transactions in the specific standards required to meet the CEHRT definition at the start of the performance period.
3. Operates in a jurisdiction where no clinical data registry for which the MIPS eligible clinician is eligible has declared readiness to receive electronic registry transactions as of 6 months prior to the start of the performance period.
We solicited comment on the proposed exclusions and whether there are circumstances that would require
In addition, we stated that we intend to propose in future rulemaking to remove the Public Health and Clinical Data Exchange objective and measures no later than CY 2022, and solicited public comment on whether MIPS eligible clinicians will continue to share such data with public health entities once the Public Health and Clinical Data Exchange objective is removed, as well as other policy levers outside of the Promoting Interoperability performance category that could be adopted for continued reporting to public health and clinical data registries, if necessary. As noted above, although we believe that these registries provide the necessary monitoring of public health nationally and contribute to the overall health of the nation, we are also focused on reducing burden and identifying other appropriate venues in which reporting to public health and clinical data registries could be reported. We solicited public comment on the role that each of the public health and clinical data registries should have in the future of the Promoting Interoperability performance category and whether the submission of this data should still be required.
Lastly, we solicited public comment on whether the Promoting Interoperability performance category is the best means for promoting sharing of clinical data with public health entities.
We solicited comment on these proposals and our summary and response are below.
After consideration of the comments we received, we are finalizing our proposals with modification. We are changing the name of the objective to Public Health and Clinical Data Exchange and adopting exclusions for each of the associated measures. As previously discussed in section III.H.3.(5)(d) of this final rule, we are adopting a final policy to allow MIPS eligible clinicians to earn full credit for this objective by reporting to two different public health agencies or clinical data registries for any of the measures associated with the objective.
We may use the comments that we received on the removal of the Public Health and Clinical Data Exchange objectives and measures to inform future rulemaking.
To assist readers in identifying the requirements of CEHRT for the Promoting Interoperability performance category objectives and measures under the scoring methodology we are finalizing in section III.I.3.h.(5)(d) of this final rule, we include Table 43, which includes the 2015 Edition certification criteria required to meet the objectives and measures.
We are working to introduce additional flexibility to allow MIPS eligible clinicians a wider range of options in selecting measures that are most appropriate to their setting, patient population, and clinical practice improvement goals. For this reason, in the CY 2019 PFS proposed rule (83 FR 35931) we solicited comment on a potential concept for future rulemaking to add two additional measure options related to health information exchange for MIPS eligible clinicians.
We received many comments in response to our request, and we will consider them as we develop future policy regarding the potential new measures that focus on health information exchange across the care continuum.
In the CY 2017 Quality Payment Program final rule (81 FR 77202), we discussed our approach to the measurement of the use of CEHRT to allow MIPS eligible clinicians and groups the flexibility to implement CEHRT in a way that supports their clinical needs. Toward that end, we adopted a policy for the 2017 and 2018 performance periods (81 FR 77202-77209 and 82 FR 53664-53670) and codified it at § 414.1380(b)(4)(i)(C)(
In the CY 2019 PFS proposed rule (83 FR 35932 through 35935), we proposed significant changes to the scoring methodology and measures beginning with the performance period in 2019. In connection with these changes, we did not propose to continue the bonus for completing certain improvement activities using CEHRT for the performance period in 2019 and subsequent performance periods. As discussed in section III.H.3.h.(5)(b) of the proposed rule, we shifted the focus of this performance category to put a greater emphasis on interoperability and patient access to health information, and we stated that we do not believe awarding a bonus for performing an improvement activity using CEHRT would directly support those goals. While we continued to believe that the use of CEHRT in completing improvement activities is extremely valuable and vital to the role of CEHRT in practice improvement, awarding a bonus in the Promoting Interoperability performance category would not be appropriate in light of the new direction we wanted to take, and we solicited comment on other ways to promote the use of CEHRT.
We invited comments on our decision not to propose to continue the bonus for completing certain improvement activities using CEHRT for the performance period in 2019 and subsequent performance periods, and our responses are below.
After consideration of the comments received, we are not continuing the bonus points for completing improvement activities using CEHRT.
We acknowledged that the omission of this bonus could be viewed as increasing burden, and sought to counteract that concern by evaluating other methods to reduce burden to offset this potential increase. We have also considered various ways to align and streamline the different performance categories under the MIPS. In lieu of the improvement activities bonus score, we have looked extensively at ways to link three of the performance categories—quality, improvement activities and Promoting Interoperability—to reduce burden and create a more cohesive and closely linked MIPS program. One possibility we have identified is to establish several sets of new multi-category measures that would cut across the different performance categories and allow MIPS eligible clinicians to report once for credit in all three performance categories. Our goal would be to establish several of combined measures so MIPS eligible clinicians could report once for credit across all three performance categories. We only solicited comment on this concept, as we are still evaluating the appropriate measure combinations and feasibility of a multi-category model.
Furthermore, we stated that to promote measurement that provides clinicians with measures that are meaningful to their practices, we intend to consider proposing in future rulemaking MIPS public health priority sets across the four performance categories (quality, improvement activities, Promoting Interoperability, and cost), and solicited comments on this topic.
We thank commenters for their views and we will consider their views as we develop future policy proposals.
In prior rulemaking (82 FR 30079), we discussed our belief that certain types of MIPS eligible clinicians (NPs, PAs, CNSs, and CRNAs) may lack experience with the adoption and use of CEHRT. Because many of these non-physician clinicians were or are not eligible to participate in the Medicare or Medicaid EHR Incentive Program (now known as the Promoting Interoperability Program), we stated that we have little evidence as to whether there are sufficient measures applicable and available to these types of MIPS eligible clinicians under the advancing care information (now known as Promoting Interoperability) performance category. We established a policy for the performance periods in 2017 and 2018 under section 1848(q)(5)(F) of the Act to assign a weight of zero to the advancing care information performance category in the MIPS final score if there are not sufficient measures applicable and available to NPs, PAs, CRNAs, and CNSs. We will assign a weight of zero only in the event that an NP, PA, CRNA, or CNS does not submit any data for any of the measures specified for the advancing care information performance category, but 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. We stated our intention to use data from the first performance period (2017) to further evaluate the participation of
Accordingly, we proposed to continue this policy for the performance period in 2019 and to codify the policy at § 414.1380(c)(2)(i)(A)(5). We requested public comments on this proposal.
The following is a summary of the comments we received on this proposal.
After consideration of the comments we received, we will continue the policy for NPs, PAs, CRNAs, and CNSs for the performance period in 2019 as proposed. We are codifying the policy at § 414.1380(c)(2)(i)(A)(5) as proposed.
As discussed in section III.H.3.a. of the proposed rule, in accordance with section 1848(q)(1)(C)(i)(II) of the Act, we proposed to add the following clinician types to the definition of a MIPS eligible clinician, beginning with the performance period in 2019: Physical therapists; occupational therapists; clinical social workers; and clinical psychologists (83 FR 35883 through 35884). For the reasons discussed in prior rulemaking and in the preceding section III.H.3.h.(5)(f) of the proposed rule, we proposed(83 FR 35933) to apply the same policy we adopted for NPs, PAs, CNSs, and CRNAs for the performance periods in 2017 and 2018 to these new types of MIPS eligible clinicians for the performance period in 2019. Because many of these clinician types were or are not eligible to participate in the Medicare or Medicaid Promoting Interoperability Program, we stated that we have little evidence as to whether there are sufficient measures applicable and available to them under the Promoting Interoperability performance category. Thus, we proposed to rely on section 1848(q)(5)(F) of the Act to assign a weight of zero to the Promoting Interoperability performance category if there are not sufficient measures applicable and available to these new types of MIPS eligible clinicians (physical therapists, occupational therapists, clinical social workers, and clinical psychologists). We encouraged all of these new types of MIPS eligible clinicians to report on these measures to the extent they are applicable and available; however, we understand that some of them may choose to accept a weight of zero for this performance category if they are unable to fully report the Promoting Interoperability measures. We stated that we believe this approach is appropriate for their first performance period (in 2019) based on the payment consequences associated with reporting, the fact that many of these types of MIPS eligible clinicians may lack experience with EHR use, and our current uncertainty as to whether we have proposed sufficient measures that are applicable and available to these types of MIPS eligible clinicians. We would use their first performance period to further evaluate the participation of these MIPS eligible clinicians in the Promoting Interoperability performance category and would consider for subsequent years whether the measures specified for this category are applicable and available to these MIPS eligible clinicians.
We stated that these MIPS eligible clinicians may choose to submit Promoting Interoperability performance category measures if they determine that these measures are applicable and available to them; however, if they choose to report, they would be scored on the Promoting Interoperability 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 Promoting Interoperability performance category score.
We proposed to codify this policy at § 414.1380(c)(2)(i)(A)(
The following is a summary of the comments we received on this proposal.
After consideration of the comments that we received, we are adopting our proposal with modification. In section
As codified at § 414.1370, MIPS eligible clinicians, including those participating in MIPS APMs, are subject to MIPS reporting requirements and payment adjustments, unless excluded on another basis.
In the CY 2017 Quality Payment Program rule, we finalized the APM scoring standard, which is designed to reduce reporting burden for participants in certain APMs by reducing the need for duplicative data submission to MIPS and their respective APMs, and to avoid potentially conflicting incentives between those APMs and the MIPS.
We established at § 414.1370(c) that the MIPS performance period under § 414.1320 applies for the APM scoring standard. We finalized under § 414.1370(f) that, under the APM scoring standard, MIPS eligible clinicians will be scored at the APM entity group level and each MIPS eligible clinician will receive the APM Entity's final MIPS score. In the CY 2019 PFS proposed rule, we proposed to amend § 414.1370(f)(2) to state that if the APM Entity group is excluded from MIPS, all eligible clinicians within that APM Entity group are also excluded from MIPS.
The MIPS final score under the APM scoring standard is comprised of the four MIPS performance categories as finalized at § 414.1370(g): Quality; cost; improvement activities; and advancing care information. In 2018, these performance categories are scored at 50 percent, 0 percent, 30 percent, and 20 percent, respectively.
In the CY 2019 PFS proposed rule, we discussed the following proposed policies:
• We proposed to revise § 414.1370(b)(3) to clarify the requirement for MIPS APMs to assess performance on quality measures and cost/utilization.
• We proposed to modify the Shared Savings Program quality reporting requirements by expanding the reporting exception for solo practitioners such that, beginning in 2019, in the case of a Shared Savings Program ACO's failure to report quality measures as required by the Shared Saving Program, we will allow a solo practitioner to report on any available MIPS measures, including individual measures.
• We proposed to clarify that, beginning in 2019, the complete reporting requirement for Web Interface reporters be modified to specify that if an APM Entity fails to complete reporting for Web Interface measures but successfully reports the CAHPS for ACOs survey, we will score the CAHPS for ACOs survey and apply it towards the APM Entity's quality performance category score. In this scenario, the Shared Savings Program TIN-level reporting exception will not be triggered and all MIPS eligible clinicians within the ACO will receive the APM Entity score.
• We clarified that we will consider each distinct track of an APM and whether it meets the criteria necessary to be a MIPS APM under § 414.1370(b)(1). We further clarified the term “track” to refer to a distinct arrangement through which an APM Entity participates in the APM, and that such participation is mutually exclusive of the APM Entity's participation in another “track” within the same APM.
• We clarified our interpretation of the rule at § 414.1370(b)(4)(i) for APMs that begin after the first day of the MIPS performance period for the year (currently January 1), where quality measures tied to payment must be reported for purposes of the APM from the first day of the MIPS performance period, and indicated that we consider the first performance year for an APM to begin as of the first date for which eligible clinicians and APM entities participating in the model must report on quality measures under the terms of the APM.
• We proposed to remove the Promoting Interoperability (formerly advancing care information) full-TIN reporting requirement for participants in the Shared Savings Program to allow individual TIN/NPIs to report for the Promoting Interoperability performance category.
• We explained how performance feedback may be accessed by ACO participant TINs in the Shared Savings Program.
• We proposed to update the MIPS APM measure sets that apply for purposes of the APM scoring standard.
In the CY 2017 Quality Payment Program final rule, we established at § 414.1370(b) that for an APM to be considered a MIPS APM, it must satisfy the following criteria: APM Entities must participate in the APM under an agreement with CMS or by law or regulation, the APM must require that APM Entities include at least one MIPS eligible clinician on a participation list, the APM must base payment incentives on performance (either at the APM entity or eligible clinician level) on cost/utilization and quality measures, and the APM must be neither a new APM for which the first performance period begins after the first day of the MIPS performance year, nor an APM in the final year of operation for which the APM scoring standard is impracticable.
As stated in the CY 2019 PFS proposed rule (83 FR 35934), it has come to our attention that there may have been some ambiguity in the third criterion at § 414.1370(b)(3). We have received questions as to whether the criterion requires MIPS APMs to base payment incentives on performance on cost/utilization “measures”, or whether it requires more generally that MIPS APMs base payment incentives on “cost/utilization.” Because we did not address this exact point in prior rulemaking and our intended policy is not strictly clear from the regulation text, we clarified in the CY 2019 PFS proposed rule that we intended the word “measures” at § 414.1370(b)(3) to modify only “quality” and not “cost/utilization.” To make this criterion clear, we proposed to modify the regulation to specify that a MIPS APM must be designed in such a way that participating APM Entities are incentivized to reduce costs of care or utilization of services, or both. This proposed change to § 414.1370(b)(3) would make it clear that a MIPS APM could take into account performance in terms of cost/utilization using model design features other than the direct use of cost/utilization measures.
We solicited comment on this proposal.
The following is a summary of the public comments received on this proposal and our responses:
We also proposed to clarify that we will consider each distinct track of an APM and whether it meets the criteria, in this final rule, to be a MIPS APM, and that it is possible for an APM to have tracks that are MIPS APMs and tracks that are not MIPS APMs. However, we specified that we will not further consider whether the individual APM Entities or MIPS eligible clinicians participating within a given track each satisfy all of the MIPS APM criteria.
For purposes of this clarification, we understand the term “track” to refer to a distinct arrangement through which an APM Entity participates in the APM, and that such participation is mutually exclusive of the APM Entity's participation in another “track” within the same APM. For example, we consider the three risk arrangements under OCM to be three separate “tracks.”
The following is a summary of the public comments received on this clarification and our responses:
We will continue to evaluate whether each distinct track of an APM meets our criteria to be a MIPS APM. We note that this may result in an APM having tracks that are MIPS APMs and tracks that are not MIPS APMs.
We also clarified our interpretation of the regulation at § 414.1370(b)(4)(i) for APMs that begin after the first day of the MIPS performance period for the year (currently January 1), but require participants to report quality data for quality measures tied to payment for the full MIPS performance period, beginning January 1. Under these circumstances where quality measures tied to payment must be reported for purposes of the APM from the first day of the MIPS performance period, we consider the first performance year for an APM to begin as of the first date for which eligible clinicians and APM entities participating in the model must report on quality measures under the terms of the APM.
The following is a summary of the public comments received on this clarification and our responses:
We are clarifying our interpretation of the regulation at § 414.1370(b)(4)(i). Therefore, we consider the first performance year for an APM to begin as of the first date for which eligible clinicians and APM entities participating in the model must report on quality measures under the terms of the APM. We believe that this interpretation will eliminate possibly conflicting incentives between the quality scoring requirements and payment incentive structures under the APM and MIPS and will reduce the likelihood of duplicative reporting of quality information.
Based on the MIPS APM criteria we expect that the following 10 APMs likely will satisfy the requirements to be MIPS APMs for the 2019 performance year:
• Comprehensive ESRD Care Model (all Tracks).
• Comprehensive Primary Care Plus Model (all Tracks).
• Next Generation ACO Model.
• Oncology Care Model (all Tracks).
• Medicare Shared Savings Program (all Tracks).
• Medicare ACO Track 1+ Model.
• Bundled Payments for Care Improvement Advanced.
• Independence at Home Demonstration.
• Maryland Total Cost of Care Model (Maryland Primary Care Program).
• Vermont All-Payer ACO Model (Vermont Medicare ACO Initiative).
Final CMS determinations of MIPS APMs for the 2019 MIPS performance year will be announced via the Quality Payment Program website at
For the quality performance category, MIPS eligible clinicians in APM Entities will continue to be scored only on the quality measures that are required under the terms of their respective APMs, and available for scoring as specified in § 414.1370(g)(1) and explained in the CY 2017 Quality Payment Program final rule (82 FR 53698, 53692).
In the CY 2018 Quality Payment Program final rule, we discussed the
For the 2019 MIPS performance year, we anticipate that there will be four Web Interface Reporter APMs: The Shared Savings Program; the Medicare ACO Track 1+ Model; Next Generation ACO Model; and the Vermont All-Payer ACO Model (Vermont Medicare ACO Initiative).
Under § 414.1370(f)(1), if a Shared Savings Program ACO does not report data on quality measures as required by the Shared Savings Program under § 425.508, each ACO participant TIN will be treated as a unique APM Entity for purposes of the APM scoring standard and the ACO participant TINs may report data for the MIPS quality performance category according to the MIPS submission and reporting requirements. In the CY 2019 PFS proposed rule (83 FR 35935), we stated that we would like to clarify that any “partial” reporting through the CMS Web Interface that does not satisfy the requirements of the Shared Savings Program will be considered a failure to report. Should a Shared Savings Program ACO fail to report, the exception under § 414.1370(f)(1) is triggered. In this scenario, each ACO participant TIN has the opportunity to report quality data to MIPS according to MIPS group reporting requirements to avoid a score of zero for the quality performance category (81 FR 77256).
We recognized that, under this policy, successfully reporting to MIPS according to group reporting requirements may be difficult for solo practitioners, for whom case thresholds and other requirements may make many group reporting measures unavailable. Therefore, we proposed to modify the exception such that beginning in 2019, in the case of a Shared Savings Program ACO's failure to report quality measures as required by the Shared Saving Program, we will also allow a solo practitioner (a MIPS eligible clinician who has only one NPI billing through their TIN), to report on any available MIPS measures, including individual measures, in the event that their ACO fails to complete reporting for all Web Interface measures.
The following is a summary of the public comments received on this clarification and our responses:
After consideration of all public comments, we are clarifying that beginning in 2019, in the case of a Shared Savings Program ACO's failure to completely report all Web Interface measures as required by the Shared Savings Program, we will allow a solo practitioner to report on any available MIPS measures, including individual measures.
We also proposed, beginning with the 2019 performance period, to modify the complete reporting requirement for Web Interface reporters to specify that if an APM Entity (in this case, an ACO) fails to complete reporting for Web Interface measures but successfully reports the CAHPS for ACOs survey, we will score the CAHPS for ACOs survey and apply it towards the APM Entity's quality performance category score. In this scenario the Shared Savings Program TIN-level reporting exception will not be triggered and all MIPS eligible clinicians within the ACO will receive the APM Entity score.
We solicited comment on this proposal.
The following is a summary of the public comments received on this proposal and our responses:
After taking all comments into account, we are not finalizing our proposal to modify the complete reporting requirement for Web Interface reporters to apply the CAHPS for ACOs survey score toward an APM Entity's quality performance category score if an ACO fails to complete reporting for Web Interface measures but successfully reports the CAHPS for ACOs survey.
Under § 414.1370(g)(1)(ii), the MIPS quality performance category score for a MIPS performance period is calculated for the APM Entity using the data submitted by the APM Entity based on measures specified by us through notice and comment rulemaking and available for scoring for each Other MIPS APM from among those used under the terms of the Other MIPS APM.
In the 2019 MIPS performance year, we anticipate that there will be up to six Other MIPS APMs for which we will use this scoring methodology, based on their respective measure sets and reporting requirements:
• The Oncology Care Model.
• Comprehensive ESRD Care Model.
• Comprehensive Primary Care Plus Model.
• Bundled Payments for Care Improvement Advanced.
• Maryland Total Cost of Care Model (Maryland Primary Care Program).
• Independence at Home Demonstration.
In the CY 2017 Quality Payment Program final rule (81 FR 77262 through 77264; 81 FR 77266 through 77269), we established a policy at § 414.1370(g)(4)(ii) for MIPS APMs other than the Shared Savings Program, under which we attribute one Promoting Interoperability performance category score to each MIPS eligible clinician in an APM Entity group based on the higher of either individual or group-level data submitted for the MIPS
For the Shared Savings Program, we also finalized at § 414.1370(g)(4)(i) that ACO participant TINs are required to report on the Promoting Interoperability performance category, and we will weight and aggregate the ACO participant TIN scores to determine an APM Entity group score (81 FR 77258 through 77260). This policy was meant to align requirements between the MIPS Promoting Interoperability measures and the Shared Savings Program ACO-11 measure, which is used to assess Shared Savings Program ACOs based on the MIPS Promoting Interoperability measures. However, we have found that limiting reporting to the ACO participant TIN creates unnecessary confusion, and restricts Promoting Interoperability reporting options for MIPS eligible clinicians who participate in the Shared Savings Program. Therefore, beginning in the 2019 MIPS performance period, we proposed (83 FR 35935) to no longer apply the requirement as finalized at § 414.1370(g)(4)(i) and instead to apply the existing policy at § 414.1370(g)(4)(ii) to MIPS eligible clinicians who participate in the Shared Savings Program so that they may report on the Promoting Interoperability performance category at either the individual or group level like all other MIPS eligible clinicians under the APM scoring standard.
We solicited comment on this proposal.
The following is a summary of the public comments received on this proposal and our responses:
After consideration of the comments received, we are finalizing the proposal to allow MIPS eligible clinicians participating in the Shared Savings Program to report on the Promoting Interoperability performance category at either the individual or group level.
As we discussed in the CY 2017 and 2018 Quality Payment Program final rules (81 FR 77270, and 82 FR 53704 through 53705, respectively), MIPS eligible clinicians who are scored under the APM scoring standard will receive performance feedback under section 1848(q)(12) of the Act.
Regarding access to performance feedback, we should note that whereas split-TIN APM Entities and their participants can only access their performance feedback at the APM Entity or individual MIPS eligible clinician level, MIPS eligible clinicians participating in the Shared Savings Program, which is a full-TIN APM, will be able to access their performance feedback at the ACO participant TIN level.
In this section, we are finalizing the following policies:
• We are modifying the MIPS APM criterion at § 414.1370(b)(3) to state that the APM bases payment on performance (either at the APM entity or eligible clinician level) on quality measures and cost/utilization.
• We are finalizing our clarification that we separately evaluate to each distinct track of an APM to determine whether it meets our criteria to be a MIPS APM. We note that this may result in an APM having some tracks that are MIPS APMs and other tracks that are not MIPS APMs.
• We are finalizing our clarification of our interpretation of the regulation at § 414.1370(b)(4)(i). Therefore, we consider the first performance year for an APM to begin as of the first date for which eligible clinicians and APM entities participating in the model must report on quality measures under the terms of the APM. We believe that this will eliminate possibly conflicting incentives between the quality scoring requirements and payment incentive structures under the APM and MIPS and will reduce the likelihood of duplicative reporting of quality information.
• Final determinations of MIPS APMs for the 2019 MIPS performance year will be made by CMS and announced on the QPP website at
• We are finalizing our policy as proposed so that beginning in 2019, if a Shared Savings Program ACO fails to report quality measures as required by the Shared Savings Program we would also allow a solo practitioner (a MIPS eligible clinician who has only one NPI billing through their TIN), to report on any available MIPS measures, including individual measures.
• We are not finalizing our proposal to modify the complete reporting requirement for Web Interface reporters so that, in the case where a Shared Savings Program ACO fails to complete reporting for Web Interface measures but successfully reports the CAHPS for ACOs survey, we would apply the CAHPS for ACOs survey toward and APM Entity's quality performance category score. Therefore, in the case where a Shared Savings Program ACO fails to successfully report Web Interface measures but does successfully report the CAHPS for ACOs survey, we will continue to treat the ACO participant TINs as unique APM Entities under the APM scoring standard and will score each TIN only on the MIPS measures it has reported.
• We are finalizing the proposal to allow MIPS eligible clinicians participating in the Shared Savings
We proposed to update the MIPS APM measure sets that apply for purposes of the APM scoring standard (83 FR 35933 through 35934). The following is a summary of the public comments received on these measure sets and our responses:
Per our policy expressed in last year's final rule (82 FR 53695 and 53696), the measure sets on the MIPS APM measure list for the year will 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, a given measure ultimately might not be used for scoring, for example if its data becomes inappropriate or unavailable for scoring.
After consideration of the comments received, we are finalizing our proposal to update the MIPS APM measure sets that apply for purposes of the APM scoring standard and will score only measures that already have been included in the measure sets of their given APM, according to the terms of participation in that APM. We note that Table 48 has been updated to reflect the most current APM measure sets.
For the 2021 MIPS payment year, we intend to build on the scoring methodology we finalized for the transition years, which allows for accountability and alignment across the performance categories and minimizes burden on MIPS eligible clinicians. The rationale for our scoring methodology continues to be grounded in the understanding that the MIPS scoring system has many components and various 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. We do so while also emphasizing simplicity and the continued development of a scoring methodology that is understandable for MIPS eligible clinicians.
In the CY 2017 Quality Payment Program final rule, we finalized a unified scoring system to determine a final score across the 4 performance categories (81 FR 77273 through 77276). For the 2019 MIPS performance period, we proposed to build on the scoring methodology we previously finalized, focusing on encouraging MIPS eligible clinicians to meet data completeness requirements (83 FR 35948 through 35949). For quality performance category scoring, we proposed to extend some of the transition year policies to the 2019 MIPS performance period, and we also proposed several modifications to existing policies (83 FR 35947 through 35949). In the CY 2018 Quality Payment Program final rule (82 FR 53712 through 53714), we established a methodology for scoring improvement in the cost performance category. However, as required by section 51003(a)(1)(B) of the Bipartisan Budget Act of 2018, we proposed that the cost performance category score would not take into account improvement until the 2024 MIPS payment year (83 FR 35956). In the CY 2018 Quality Payment Program final rule (82 FR 53753 through 53767), we finalized the availability of a facility-based measurement option for clinicians who met certain requirements, beginning with the 2019 MIPS performance period. As discussed in section III.I.3.i.(1)(d) of this final rule, we are finalizing our proposal to change the determination of facility-based measurement to include consideration of presence in the on-campus outpatient hospital. The policies for scoring the 4 performance categories are described in detail in section III.I.3.i.(1) of this final rule.
These policies will help eligible clinicians as they participate in the 2019 MIPS performance period/2021 MIPS payment year, and as we move beyond the transition years of the program. Section 51003 of the Bipartisan Budget Act of 2018 provides flexibility to continue the gradual ramp up of the Quality Payment Program and enables us to extend some of the transition year policies to the 2019 performance period.
Unless otherwise noted, for purposes of this section III.I.3.i. of this final rule, the term “MIPS eligible clinician” will refer to MIPS eligible clinicians who collect and submit data and are scored at either the individual or group level, including virtual groups; it will not refer to MIPS eligible clinicians who are scored by facility-based measurement, as discussed in section III.I.3.i.(1)(d) of this final rule. We also note that the APM scoring standard applies to MIPS eligible clinicians in APM Entities in MIPS APMs, and those policies take precedence where applicable. Where those policies do not apply, scoring for MIPS eligible clinicians as described in section III.I.3.h.(6) of this final rule will apply. We refer readers to section III.I.4. of this final rule for additional information about the APM scoring standard.
Although we did not propose changing the basic scoring system that we finalized in the CY 2018 Quality Payment Program final rule for the 2021 MIPS payment year (82 FR 53712 through 53748), we proposed several modifications to scoring the quality performance category, including removing high-priority measure bonus points for CMS Web Interface measures and extending the bonus point caps, and adding a small practice bonus to the quality performance category score. The following section describes these previously finalized policies and our proposals (83 FR 35950 through 35952).
We also proposed updates to § 414.1380(b)(1) in an effort to more clearly and concisely capture previously established policies (83 FR 35946 through 35955). These proposed updates are not intended to be substantive in nature, but rather to bring more clarity to the regulatory text. We will make note of the updated regulatory citations in their relevant sections below.
In the CY 2017 and CY 2018 Quality Payment Program final rules (81 FR 77008 through 77831 and 82 FR 53568 through 54229, respectively), we used the term “submission mechanisms” in reference to the various ways in which a MIPS eligible clinician or group can submit data to CMS. As discussed in section III.I.3.h.(1)(b) of this final rule, it has come to our attention that the way we have described the various ways in which MIPS eligible clinicians, groups and third-party intermediaries can submit data to our systems does not accurately reflect the experience users have when submitting data to us. We refer readers to section III.I.3.h.(1)(b) of this final rule for further discussion on our finalized changes to the scoring terminology related to measure specification and data collection and submission. For additional discussion on the impact of the proposed terminology change on our benchmarking methodology, validation process, and end-to-end reporting bonus, we refer readers to sections III.I.3.i.(1)(b)(ii), (v), and (x) of this final rule.
We refer readers to the CY 2017 and CY 2018 Quality Payment Program final rules (81 FR 77282 and 82 FR 53718, respectively) for our previously established benchmarking policies. As part of our proposed technical updates to § 414.1380(b)(1) discussed in section III.I.3.i.(1)(a)(i) of this final rule, our previously established benchmarking policies at § 414.1380(b)(1)(i) through (iii) would now be referenced at § 414.1380(b)(1)(i) through (ii).
When we developed the quality measure benchmarks, we sought to develop a system that enables MIPS eligible clinicians, beneficiaries, and other stakeholders to understand what is required for a strong performance in MIPS while being consistent with statutory requirements (81 FR 28249 through 28250). The feedback we have received thus far from stakeholders on our benchmarks is helping to inform our approach to the benchmarking methodology, especially as we look for possible ways of aligning with Physician Compare benchmarks. As described in section III.I.3.i.(1)(b)(xii) of this final rule, we solicited comment on potential future approaches to scoring the quality performance category to continue to promote value and improved outcomes.
We anticipate changes in scoring would be paired with potential modifications to measure selection and criteria discussed in section III.I.3.h.(2)(b) of this final rule. In the CY 2019 PFS proposed rule (83 FR 35947), we sought input on opportunities to further reduce confusion about our benchmarking methodology described in the CY 2017 Quality Payment Program final rule (81 FR 77277 through 77278), which includes further clarification of our benchmarking process and potential areas of alignment between the MIPS and Physician Compare benchmarking methodologies.
We thank commenters for their input and may take this input into consideration in future years.
We previously established at § 414.1380(b)(1)(iii) separate benchmarks for the following submission mechanisms: EHR; QCDR/registry, claims; CMS Web Interface; CMS-approved survey vendor; and administrative claims. In the CY 2019
The following is a summary of the public comments on these proposals and our responses:
After consideration of public comments, we are finalizing our proposal, beginning with the 2021 MIPS payment year, to amend § 414.1380(b)(1)(ii) to establish separate benchmarks based on collection type and to remove the mention of each individual benchmark and state that benchmarks will be based on collection type, from all available sources, including MIPS eligible clinicians and APMs, to the extent feasible, during the applicable baseline or performance period.
In the CY 2017 Quality Payment Program final rule, we established the policies for scoring quality measures performance (81 FR 77286). We refer readers to § 414.1380(b)(1) for more on these policies.
For the 2019 and 2020 MIPS payment years, we finalized at § 414.1380(b)(1)(i) a global 3-point floor for each scored quality measure, as well as for the hospital readmission measure (if applicable). In this way, 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; 82 FR 53719). 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 periods after the first transition year (81 FR 77282, 77287; 82 FR 53719). For measures with benchmarks based on the baseline period, we stated that 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; 82 FR 53719).
For the 2021 MIPS payment year, 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)(i) accordingly (83 FR 35947). We will revisit the 3-point floor for such measures again in future rulemaking.
We requested comments on the proposal above. These comments and our responses are discussed below.
After consideration of public comments, we are finalizing our proposal, for the 2021 MIPS payment year, to apply a 3-point floor for each measure that can be reliably scored against a benchmark, and to amend § 414.1380(b)(1)(i) accordingly.
Although participating in the CAHPS for MIPS survey is optional for all groups, some groups will be unable to participate in the CAHPS for MIPS survey because they do not meet the minimum beneficiary sampling requirements. CMS has sampling requirements for groups of 100 or more eligible clinicians, 25 to 99 eligible clinicians, and 2 to 24 eligible clinicians to ensure an adequate number of survey responses and the ability to reliably report data. Our sampling timeframes necessitate notifying groups of their inability to meet the sampling requirements late in the performance period (see 82 FR 53630 through 53632). As a result, we are concerned that some groups that expect and plan to meet the quality performance category requirements using the CAHPS for MIPS survey may find out late in the performance period that they are unable to meet the sampling requirements and, therefore, are unable to have their performance assessed on this measure. These groups may need to report on another measure to meet the
We want to encourage the reporting of the CAHPS for MIPS survey and do not want the uncertainty regarding sampling requirements to be a barrier to selecting the CAHPS for MIPS survey. To mitigate this concern, beginning with the 2021 MIPS payment year, we proposed to reduce the denominator (that is, the total available measure achievement points) for the quality performance category by 10 points for groups that register for the CAHPS for MIPS survey but do not meet the minimum beneficiary sampling requirements (83 FR 35948). By reducing the denominator instead of only assigning the group a score of zero measure achievement points (because the group would be unable to submit any CAHPS for MIPS survey data), we are effectively removing the impact of the group's inability to submit the CAHPS for MIPS survey. We believe this reduction in denominator would remove any need for groups to find another measure if they are unable to submit the CAHPS for MIPS survey. Therefore, we proposed to amend § 414.1380 to add paragraph (b)(1)(vii)(B) to state that we will reduce the total available measure achievement points for the quality performance category by 10 points for groups that registered for the CAHPS for MIPS survey but do not meet the minimum beneficiary sampling requirements.
We requested comments on the proposal above. These comments and our responses are discussed below.
The notification will also encourage groups to select other relevant improvement activities that can be completed within the performance period. We refer readers to section III.I.3.h.(4)(b) of this final rule for further information on submission criteria for the improvement activities performance category.
After consideration of public comments, we are finalizing our proposal to amend § 414.1380 to add paragraph (b)(1)(vii)(B) to state that we will reduce the total available measure achievement points for the quality performance category by 10 points for groups that submit 5 or fewer quality measures and register for the CAHPS for MIPS survey, but do not meet the minimum beneficiary sampling requirements.
We do not want groups to register for the CAHPS for MIPS survey if they know in advance that they are unlikely to be able to meet the sampling requirement, so we solicited comments on whether we should limit this proposed policy to groups for only one MIPS performance period. For example, for the performance period following the application of this proposed policy, a notice could be provided to groups during registration indicating that if the sampling requirement is not met for a second consecutive performance period, the proposed policy will not be applied. This would provide notice to the group that they may not meet the sampling requirement needed for the CAHPS for MIPS survey and may need to look for alternate measures but does not preclude the group from registering for the CAHPS for MIPS survey if they expect to meet the minimum beneficiary sampling requirements in the second MIPS performance period.
We thank commenters for their suggestions and may consider them for future rulemaking.
We refer readers to CY 2017 Quality Payment Program final rule (82 FR 53721 through 53727) for our established policies for scoring topped out measures.
Under § 414.1380(b)(1)(xiii)(A), for the 2020 MIPS payment year, 6 measures will receive a maximum of 7 measure achievement points, provided that the applicable measure benchmarks are identified as topped out again in the benchmarks published for the 2018 MIPS performance period. Under § 414.1380(b)(1)(xiii)(B), beginning with the 2021 MIPS payment year, measure benchmarks (except for measures in the CMS Web Interface) that are identified as topped out for 2 or more consecutive years will receive a maximum of 7 measure achievement points beginning in the second year the measure is identified as topped out (82 FR 53726 through 53727). As part of our technical updates to § 414.1380(b)(1) outlined in section III.I.3.i.(1)(b) of this final rule, our previously finalized topped out scoring policies are now referenced at § 414.1380(b)(1)(iv).
We refer readers to the 2018 MIPS Quality Benchmarks' file that is located on the Quality Payment Program resource library (
We did not propose to apply our previously finalized topped out scoring policy to the CAHPS for MIPS survey (82 FR 53726). Because the CAHPS for MIPS survey was revised in 2018 (82 FR 53632), we do not have historical benchmarks for the 2018 performance period, so the topped out policy would not be applied for the 2019 performance period. Last year, we received limited feedback when we sought comment on how the topped out scoring policy should be applied to CAHPS for MIPS survey. In CY 2019 PFS proposed rule, we sought feedback on potential ways we can score CAHPS for MIPS Summary Survey Measures (SSM) (83 FR 35948). For example, we could score all SSMs, which means there would effectively be no topped out scoring for CAHPS for MIPS SSMs, or we could cap the SSMs that are topped out and score all other SSMs. We sought comment on these approaches and additional approaches to the topped out scoring policy for CAHPS for MIPS SSMs. We noted that we encourage groups to report the CAHPS for MIPS survey as it incorporates beneficiary feedback.
We thank commenters for their suggestions and will consider them for future rulemaking.
In the CY 2017 Quality Payment Program final rule (81 FR 77288 through 77289), we established scoring policies for a measure that 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. As part of our technical updates to § 414.1380(b)(1) discussed in section III.I.3.i.(1)(b) of this final rule, our previously finalized scoring policies are now referenced at § 414.1380(b)(1)(i)(A) and (B).
A summary of the current and proposed policies is provided in Table 50. For more of the statutory background and details on current policies, we refer readers to the CY 2017 and CY 2018 Quality Payment Program final rules (81 FR 77288 through 77289 and 82 FR 53727 through 53730, respectively).
As the MIPS program continues to mature, we are looking to find ways to improve our policies, including what to do with measures that do not meet the case minimum. Although many MIPS eligible clinicians can meet the 20-case minimum requirement, we recognize that small practices and individual MIPS eligible clinicians may have difficulty meeting this standard. Although we process data from the CY 2017 MIPS performance period to determine how often submitted measures do not meet case minimums, we invited public comment on ways we can improve our case-minimum policy. In determining future improvements to our case minimum policy, our goal is to
We thank commenters for their suggestions and will consider them for future rulemaking.
In the CY 2019 PFS proposed rule (83 FR 35949), we proposed to maintain the policies finalized for the CY 2018 MIPS performance period regarding measures that do not meet the case-minimum requirement, do not have a benchmark, or do not meet the data-completeness criteria for the CY 2019 MIPS performance period, and to amend § 414.1380(b)(1)(i) accordingly.
We also proposed to assign zero points for measures that do not meet data completeness starting with the CY 2020 MIPS performance period and to amend § 414.1380(b)(1)(i)(B)(
We requested comments on the proposals above. These comments and our responses are discussed below.
After consideration of public comments, we are finalizing the proposal to maintain the policies finalized for the CY 2018 MIPS performance period regarding measures that do not meet the case-minimum requirement, do not have a benchmark, or do not meet the data-completeness criteria for the CY 2019 MIPS performance period, and the amending of § 414.1380(b)(1)(i) accordingly.
After consideration of public comments, we are finalizing our proposal to assign zero points for measures that do not meet data completeness starting with the CY 2020 MIPS performance period and to amend § 414.1380(b)(1)(i)(B)(1) accordingly. Measures submitted by small practices will continue to receive 3 points for all future MIPS performance periods.
In the CY 2018 Quality Payment Program final rule (82 FR 53714 through 53716), we finalized that, beginning with the 2018 MIPS performance period, 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). 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). Lastly, we finalized that we will publish the list of measures requiring a 9-month assessment process on the CMS website by October 1st of the performance period if technically feasible, but by no later than the beginning of the data submission period (for example, January 2, 2019, for the 2018 MIPS performance period). As part of our technical updates to § 414.1380(b)(1) outlined in section III.I.3.i.(1)(b) of this final rule, these previously finalized policies are now referenced at § 414.1380(b)(1)(viii).
We remain concerned about instances where clinical guideline changes or other changes to evidence supporting a measure occur during the performance period that may significantly impact a measure. Clinical guidelines and protocols developed by clinical experts and specialty medical societies often underpin quality measures. At times, measure stewards must amend quality measures to reflect new research and changed clinical guidelines, and sometimes, as a result of the change in these guidelines, adherence to guidelines in the existing measures could result in patient harm or otherwise provide misleading results as to good quality care. We sought comment in the CY 2018 Quality Payment Program final rule regarding whether we should apply scoring flexibility to measures significantly impacted by clinical guideline changes (82 FR 53716). We refer readers to the CY 2019 PFS proposed rule for a summary of the comments we received (83 FR 35949 through 35950).
We remain concerned that findings of evidence-based research, providing the basis for sound clinical practice guidelines and recommendations that are the foundation of a quality measure, may change outside of the rulemaking cycle. As the clinical evidence and guidelines change, approved measures may no longer reflect the most up-to-date clinical evidence and could be contrary to patient well-being. There may be instances in which changes to clinical guidelines are so significant, that an expedited review is needed outside of the rulemaking cycle because measures may result in a practice that is harmful to patients. To further align with policies adopted within other value based programs such as the Hospital VBP Program (83 FR 20409), we proposed to suppress a measure without rulemaking, if during the performance period a measure is
In the CY 2019 PFS proposed rule (83 FR 35950), we proposed policies to provide scoring flexibility in the event that we need to suppress a measure during a performance period. Scoring for a suppressed measure would result in a zero achievement points for the measure and a reduction of the total available measure achievement points by 10 points. We believe that this approach effectively removes the impact of the eligible clinician's inability to receive measure achievement points for the measure, if a submitted measure is later suppressed.
We also proposed to add a new paragraph at § 414.1380(b)(1)(vii) that, beginning with the 2019 MIPS performance period, CMS will reduce the total available measure achievement points for the quality performance category by 10 points for MIPS eligible clinicians that submit a measure significantly impacted by clinical guideline changes or other changes that CMS believes may pose patient safety concerns (83 FR 35950).
We requested comments on the proposal above. These comments and our responses are discussed below.
In the event of the need for the special scoring policy, we would communicate to clinicians through multiple channels regarding the changes. We appreciate that clinicians invest significant time and resources to select measures, we also believe it is critical that the measure results do not cause patient harm or otherwise harm clinician performance by scoring potentially misleading data. We believe suppressing the measure and reducing the total possible achievement points by 10 would recognize this effort by not forcing clinicians in the middle of a performance to select a new measure to report.
We appreciate the time and resources clinicians expend to collect data for a quality measure; however, we believe the policy will only be used in rare occasions, which will limit disruption to clinicians. We also believe that the policy will not disadvantage the clinician and will “hold harmless” any clinician submitting data on the measure. Scoring would be suppressed for any clinician that submitted data on the measure prior to the announcement. Similarly, given how rarely we anticipate we will need to use this policy, we do not believe we require a process for attestation regarding which measures will be selected prior to the performance period.
After consideration of public comments, we are finalizing a modification of our proposal and adding a new paragraph at § 414.1380(b)(1)(vii) stating that, beginning with the 2021 MIPS payment year, we will reduce the denominator of available measure achievement points for the quality performance category by 10 points for MIPS eligible clinicians for each measure submitted that is significantly impacted by clinical guideline changes or other changes when we believe adherence to the guidelines in the existing measures could result in patient harm or otherwise provide misleading results as to good quality care. To clarify, we regularly monitor changes to quality measures and clinical guidelines and we will rely mainly on measure stewards, who often defer to the clinical organizations or other stakeholders who own, maintain and update the clinical guideline when a guideline change is warranted, for notification in changes to clinical guidelines. We will publish on the CMS website suppressed measures whenever technically feasible, but by no later than the beginning of the data submission period.
In the CY 2018 Quality Payment Program final rule (82 FR 53732), we finalized that, beginning with the 2021 MIPS payment year, we will validate the availability and applicability of quality measures only with respect to the collection type that a MIPS eligible clinician utilizes for the quality performance category for a performance period, and only if a MIPS eligible clinician collects via claims only, MIPS CQMs only, or a combination of MIPS CQMs and claims collection types. We will not apply the validation process to any data collection type that the MIPS eligible clinician does not utilize for the quality performance category for the performance period. We sought comment on how to modify the validation process for the 2021 MIPS payment year when clinicians may submit measures collected via multiple collection types.
As discussed in section III.I.3.h.(1)(b) of this final rule, we proposed to revise our terminology regarding data submission. This updated terminology will more accurately reflect our current submissions and validation policies. In the CY 2019 PFS proposed rule (83 FR 35950), we proposed to modify our validation process to provide that it only applies to MIPS CQMs and the claims collection type, regardless of the submitter type chosen. For example, this policy would not apply to eCQMs even if they are submitted by a registry.
We note that a MIPS eligible clinician may not have available and applicable quality measures. If we are unable to score the quality performance category, then we may reweight the clinician's score according to the reweighting policies described in sections III.I.3.i.(2)(b)(ii) and III.I.3.i.(2)(b)(iii) of this final rule.
We did not receive any comments on this proposal.
We are finalizing our proposal to modify our validation process to provide that it only applies to MIPS CQMs and the claims collection type, regardless of the submitter type chosen.
In the CY 2018 Quality Payment Program final rule (82 FR 53788), we finalized at § 414.1380(c)(4) to add a small practice bonus of 5 points to the final score for the 2020 MIPS payment year for MIPS eligible clinicians, groups, APM Entities, and virtual groups that meet the definition of a small practice as defined at § 414.1305 and submit data on at least one performance category in the 2018 MIPS performance period.
We continue to believe an adjustment for small practices is generally appropriate due to the unique challenges small practices experience related to financial and other resources, as well as the performance gap we have observed (based on historical PQRS data) for small practices in comparison to larger practices. We believe a small practice bonus specific to the quality performance category is preferable for the 2021 MIPS payment year and future years. We believe it is appropriate to apply a small practice bonus points to the quality performance category based on observations using historical data, which indicates that small practices are less likely to submit quality performance data, less likely to report as a group and use the CMS Web Interface, and more likely to have lower performance rates in the quality performance category than other practices. We want the final score to reflect performance, rather than the ability and infrastructure to support submitting quality performance category data.
We considered whether we should continue to apply the small practice bonus through bonus points in all 4 performance categories, but believe the need for doing so is less compelling. The improvement activities performance category already includes special scoring for small practices (please refer to § 414.1380(b)(3) and see section III.I.3.i.(1)(e) of this final rule for more information). In addition, for the Promoting Interoperability performance category, small practices can apply for a significant hardship exception if they have issues acquiring an EHR (see section III.I.3.h.(5) of this final rule). Finally, the cost performance category does not require submission of any data; therefore, there is less concern about a small practice being burdened by those requirements. For these reasons, we proposed to transition the small practice bonus to the quality performance category.
Starting with the 2021 MIPS payment year, we proposed at § 414.1380(b)(1)(v)(C) to add a small practice bonus of 3 points in the numerator of the quality performance category for MIPS eligible clinicians in small practices if the MIPS eligible clinician submits data to MIPS on at least 1 quality measure (83 FR 35950). Because MIPS eligible clinicians in small practices are not measured on the readmission measure and are not able to participate in the CMS Web Interface, they generally have a quality performance category denominator of 60 total possible measure achievement points. Thus, our proposal of 3 measure bonus points generally represents 5 percent of the quality performance category score. As described in section III.I.3.i.(2)(b)(iii) of this final rule, for clinicians in many small practices, the
With a weight of 85 percent, a small practice bonus of 3 points added to the quality performance category will result in 4.25 bonus points added to the final score for clinicians in small practices.
We requested comments on the proposal above. These comments and our responses are discussed below.
With our updated impact analysis in this final rule, we discovered that trends identified when we originally established the small practice bonus still exist. For example, in the CY 2018 Quality Payment Program proposed rule (82 FR 30139 through 30140), we noted that clinicians in practices with more than 100 clinicians may perform better in the Quality Payment Program on average compared to clinicians in smaller practices. We believed this trend was due primarily to two factors: Participation rates and Web Interface reporting. While we estimate more clinicians in small practices are participating in MIPS in our updated model in this final rule compared to our estimates in the 2019 PFS proposed rule, we still see a gap in quality participation when comparing clinicians in small practices to clinicians in large practices (89.8 percent compared to 100.0 percent respectively). We also noticed a discrepancy in performance among those who submitted data for the quality performance category. Prior to applying a small practice bonus, the average quality score for submitters in small practices was 62 percent compared to 82 percent for clinicians in large groups. It is unclear whether the cause of the discrepancy is related to Web Interface reporting, to performance, or to factors related to data collection. While we continue to analyze the implications of these results, we believe increasing the small practice bonus from 3 to 6 measure bonus points for 1 year would be appropriate to ensure that we are correctly incentivizing participation
We want to remind readers that the small practice bonus was only meant to be temporary and as we further analyze CY 2017 MIPS performance period data we expect that the bonus will likely be reduced or removed in future rulemaking. While we currently believe that it is appropriate due to the unique challenges small practices experience related to financial and other resources, as well as the performance gap for small practices in comparison to larger practices, we believe that upon further analysis of CY 2017 MIPS performance period data the small practice bonus may not address the underlying reasons for the disparate performance between small practices and other clinicians. As a result, we intend to revisit this bonus during next year's rulemaking cycle.
As discussed in the response above, we have estimated quality performance category scores using data from the 2017 MIPS performance period. As a result of this new data that was not available before the publication of the proposed rule we believe increasing the small practice bonus from 3 to 6 measure bonus points would be appropriate to ensure that we are correctly incentivizing participation without lowering the final score of small practices. The other bonuses in the quality performance category (for high-priority measures and end-to-end electronic reporting) are capped at 10 percent of the denominator of the quality performance category, which in almost all cases for small practices is 60 total possible measure achievement points. Setting the bonus at 6 points generally represents 10 percent of the quality performance category score.
After consideration of public comments, we are not finalizing as proposed the proposal to amend § 414.1380(b)(1)(v)(C) to add, beginning with the 2021 MIPS payment year, a small practice bonus of 3 measure bonus points in the numerator of the quality performance category for MIPS eligible clinicians in small practices if the MIPS eligible clinician submits data to MIPS on at least 1 quality measure. Instead, based on the rationale discussed previously, we are finalizing the amendment of § 414.1380(b)(1)(v)(C) to add, beginning with the 2021 MIPS payment year, a small practice bonus of 6 measure bonus points in the numerator of the quality performance category for MIPS eligible clinicians in small practices if the MIPS eligible clinician submits data to MIPS on at least 1 quality measure.
In the CY 2017 Quality Payment Program final rule, we established a cap on high-priority measure bonus points for the first 2 years of MIPS 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 (81 FR 77294). As part of our proposed technical updates to § 414.1380(b)(1) discussed in section III.I.3.i.(1)(b) of this final rule, our previously established policy on incentives to report high-priority measures is now referenced at § 414.1380(b)(1)(v)(A). In the CY 2019 PFS proposed rule, we proposed to maintain the cap on measure bonus points for reporting high-priority measures for the 2021 MIPS payment year, and to amend § 414.1380(b)(1)(v)(A)(1)(ii), accordingly (83 FR 35951).
We requested comments on the proposal above. These comments and our responses are discussed below.
After consideration of public comments, we are finalizing our proposal to maintain the cap on measure bonus points for reporting high-priority measures for the 2021 MIPS payment year, and to amend § 414.1380(b)(1)(v)(A)(1)(ii), accordingly.
We established the scoring policies for high-priority measure bonus points in the CY 2017 Quality Payment Program final rule (81 FR 77293). We noted that, in addition to the required measures, CMS Web Interface reporters may also report the CAHPS for MIPS survey and receive measure bonus points for submitting that measure (81 FR 77293). We refer readers to § 414.1380(b)(1)(v)(A) for more details on the high-priority measure bonus points scoring policies.
For the 2021 MIPS payment year, we proposed to modify the policies finalized in the CY 2017 Quality Payment Program final rule (and amend § 414.1380(b)(1)(v)(A) accordingly) to discontinue awarding measure bonus points to CMS Web Interface reporters for reporting high-priority measures (83 FR 35951). As we continue to move forward in implementing the MIPS program, we no longer believe that it is appropriate to award CMS Web Interface reporters measure bonus points to be consistent with other policies regarding selection of measures. Based on additional data analyses since the first-year policy was implemented,
We requested comments on the proposal above. These comments and our responses are discussed below.
We will consider commenters' concerns in future rulemaking.
After consideration of public comments, we are finalizing our proposal, beginning with the 2021 MIPS payment year, to discontinue awarding measure bonus points to CMS Web Interface reporters for reporting high-priority measures and to amend § 414.1380(b)(1)(v)(A) accordingly.
As part of our move towards fully implementing the high value measures as discussed in section III.I.3.h.(2)(b)(iv) of this final rule, we believe that bonus points for high priority measures for all collection types may no longer be needed, and as a result, we intend to consider in future rulemaking whether to modify our scoring policy to no longer offer high priority bonus points after the 2021 MIPS payment year (83 FR 35951).
We thank commenters for suggestions and may consider them for future rulemaking.
Section 1848(q)(5)(B)(ii) of the Act requires the Secretary to encourage MIPS eligible clinicians to report on applicable quality measures through the use of CEHRT. Under § 414.1380(b)(1)(xv), 1 bonus point is available for each quality measure submitted with end-to-end electronic reporting, under certain criteria. In order to receive the bonus for end-to-end reporting, eligible clinicians must use the 2015 Edition CEHRT. We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77297) and section III.I.3.h.(2)(b)(i) of this final rule for further discussion on our certification requirements for the end-to-end reporting bonus. As part of our proposed technical updates to § 414.1380(b)(1) discussed in section III.I.3.i.(1)(b) of this final rule, our previously established electronic end-to-end reporting bonus point scoring policy is now referenced at § 414.1380(b)(1)(v)(B).
In the CY 2019 PFS proposed rule, we proposed to maintain the cap on measure bonus points for end-to-end electronic reporting for the 2021 MIPS payment year (83 FR 35951). We also proposed to continue to assign bonus points for end-to-end electronic reporting for the 2021 MIPS payment year, as we have seen that this policy encourages electronic reporting. We proposed to amend § 414.1380(b)(1)(v)(B) accordingly.
We requested comments on the proposal above. These comments and our responses are discussed below.
After consideration of public comments, we are finalizing our proposals to continue to assign and maintain the cap on measure bonus points for end-to-end electronic reporting for the 2021 MIPS payment year and to amend § 414.1380(b)(1)(v)(B) accordingly.
We also proposed to modify our end-to-end reporting bonus point scoring policy based on the changes to the submission terminology discussed in section III.I.3.h.(1)(b) of this final rule (83 FR 35951). We proposed that the end-to-end reporting bonus can only apply to the subset of data submitted by direct, log in and upload, and CMS Web Interface that meet the criteria finalized in the CY 2017 Quality Payment Program final rule (81 FR 77297 through 77298). However, the end-to-end reporting bonus would not be applied to the claims submission type because it does not meet the criteria discussed above. This is not a policy change but rather a clarification of our current process in light of the proposed terminology changes.
We did not receive any comments on this proposal.
After consideration of public comments, we are finalizing our proposals to modify our end-to-end reporting bonus point scoring policy based on the changes to the submission terminology and only apply the bonus to the subset of data submitted by direct, log in and upload, and CMS Web Interface that meet the criteria finalized in the CY 2017 Quality Payment Program final rule (81 FR 77297 through 77298).
As discussed in section III.I.3.i.(1)(b)(x) of this final rule, we believe that in the future, bonus points for end-to-end reporting for all submission types will no longer be needed as we move towards fully implementing the program, and as a result we intend to consider in future rulemaking modifying our scoring policy to no longer offer end-to-end reporting bonus points after the 2021 MIPS payment year (83 FR 35951). Consistent with the section 1848(q)(5)(B)(ii) of the Act, which requires the Secretary to encourage the use of CEHRT for quality reporting, we will continue to be committed to ways that we can incentivize and encourage these reporting methods. We invited comment on other ways that we can encourage the use of CEHRT for quality reporting.
We thank commenters for suggestions and will consider them for future rulemaking.
In the CY 2017 and 2018 Quality Payment Program final rules (81 FR 77300, and 82 FR 53733 through 53736, respectively), we established the policy for calculating total measure achievement and measure bonus points for Non-CMS Web Interface reporters. We refer readers to § 414.1380(b)(1) for more details on these policies.
We did not propose any changes to the policy for scoring submitted measures collected across multiple collection types; however, we provided a summary of how this policy will be scored using our new terminology (83 FR 35952). We noted that CMS Web Interface and facility-based measurement each have a comprehensive set of measures that meet the proposed MIPS category requirements. As a result, we did not combine CMS Web Interface measures or facility-based measurement with other ways groups can be scored for data submitted for MIPS (other than CAHPS for MIPS, which can be submitted in conjunction with the CMS Web Interface). We refer readers to section III.I.3.i.(1)(d) of this final rule for a description of our policies on facility-based measurement (83 FR 35956 through 35963).
Although we have established a policy to account for scoring in circumstances when the same measure is collected via multiple collection types, we anticipate that this will be a rare circumstance and do not encourage clinicians to submit the same measure collected via multiple collection types. Table 51 is included in this final rule for illustrative purposes and clarity due to the changes in terminology discussed in section III.I.3.h.(1)(b) of this final rule (83 FR 35893 through 35895). For further discussion of this example, we refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53734).
We did not propose any changes to our policy regarding scoring measure achievement points and bonus points when using multiple collection types for non-Web Interface MIPS eligible clinicians in the quality performance category for the 2019 MIPS performance period.
In the CY 2017 and 2018 Quality Payment Program final rules (81 FR 77302 through 77306, and 82 FR 53736 through 82 FR 53737, respectively), we finalized the scoring policies for CMS Web Interface reporters. As part of our technical updates to § 414.1380(b)(1) discussed in section III.I.3.i.(1)(b) of this final rule, our previously established policies for CMS Web Interface reporters are now referenced at § 414.1380(b)(1)(i)(A)(
As we discuss in section III.I.3.h.(2)(b)(iv) of this final rule, we anticipate making changes to the quality performance category to reduce burden and increase the value of the measures we are collecting. We discussed that existing measures have differing levels of value and our approaches for implementing a system where points are awarded based on the value of the measure. Should we adopt these approaches, we anticipate needing to modify our scoring approaches accordingly. In addition, we have received stakeholder feedback requesting that we simplify scoring for the quality performance category. Therefore, we solicited comment on the following approaches to scoring that we may consider in future rulemaking and whether these approaches move the clinicians towards reporting high value measures and more accurate performance measurement (83 FR 35954 through 35955).
One option for simplification is restructuring the quality requirements with a pre-determined denominator, for example, 50 points, but no specific requirements regarding the number of measures that must be submitted. Further, we would categorize MIPS and QCDR measures by value, because we recognize that not all measures are created equal. We seek to ensure that the collection and submission of data is valuable to clinicians and worth the cost and burden of collection of information. A system to classify measures as a particular value (for example, gold, silver, or bronze) is discussed in section III.I.3.h.(2)(b)(iv) of this final rule. In this approach, the highest tier would include measures that are considered “gold” standard, such as outcome measures, composite measure, or measures that address agency priorities (such as opioids). The CAHPS for MIPS survey, which collects patient experience data, may also be considered a high-value measure. Measures considered in the second tier, or at a “silver” standard, would be process measures that are directly related to outcomes and have a good gap in performance (there is no high, unwavering performance) and demonstrate room for improvement, or topped out outcome measures. Lower value measures, such as standard of care process measures or topped out process measures, would have scoring caps in place that would reflect the measure's status as a “bronze measure.” In this scenario, we could envision awarding points for achievement as follows: Up to 15 to 20 points in the top tier; up to 10 points in the next tier; and up to 5 points in the lowest tier. Similar to the structure of the improvement activities performance category, a clinician that chooses a top-tier measure would not have to submit as many measures to MIPS. We would still want to ensure the submission of high value measures and might include requirements that restrict the number of lower tier measures that could be submitted; alternatively, we could add a requirement that a certain number of higher tier measures would need to be submitted. With this approach, we could still incentivize reporting on high-priority measures by classifying them as “gold” standard measures which would be eligible for up to 15 to 20 achievement points.
Alternatively, we could keep our current approach for the quality performance category requiring 6 measures including one outcome measure, with every measure worth up to 10 measure achievement points in the denominator but change the minimum number of measure achievement points available to vary by the measure tier. For example, high-tier measures could qualify for high priority bonus and/or have a higher potential floor (for example, 5 measure achievement points instead of the floor of 3 measure achievement points for “gold” standard measures, which would be eligible for up to 10 measure achievement points.); whereas low-tier measures could have a lower floor (for example, 1 measure achievement point instead of the floor of 3 measure achievement points for “bronze standard' measures).
Taking into consideration the potential future quality performance category change, we also believe that removing the validation process to determine whether the eligible clinician has measures that are available and applicable would simplify the quality performance category significantly. Several stakeholders have expressed their confusion with the validation process. A move to sets of measures in the quality performance category, potentially with some criteria to define the clinicians for whom these measures are applicable, would eliminate the need for a validation process for measures that are available and
We also recognize that improving the electronic capture, calculation, and reporting of quality measures is also an important component of reducing provider burden. We invited comment on how we can incorporate incentives for the use of electronic clinical quality measurement into the future approaches described under this section, as well as other ways to encourage more efficient technology-enabled measurement approaches.
We solicited comment on these approaches and other approaches to simplify scoring, provide incentives to submit more impactful measures that assess outcomes rather than processes, and develop data that can show differences in performance and determine clinicians that provide high value care (83 FR 35954 through 35955).
We thank commenters for suggestions and will consider them for future rulemaking.
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, the improvement of the quality performance category score for eligible clinicians should be measured. To measure improvement, we require a direct comparison of data from one Quality Payment Program year to another (82 FR 52740). For more descriptions of our current policies, we refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53737 to 53747). As part of our technical updates to § 414.1380(b)(1) discussed in section III.I.3.i.(1)(b) of this final rule, our previously established improvement scoring policies are now referenced at § 414.1380(b)(1)(vi).
In the CY 2018 Quality Payment Program final rule, we adopted a policy that MIPS eligible clinicians must fully participate to receive a quality performance category improvement percent score greater than zero (82 FR 53743 through 53745). In § 414.1380(b)(1)(vi)(F), we determined “participation” to mean compliance with § 414.1330 and § 414.1340 in the current performance period. We issued a technical correction for the CY 2018 Quality Payment Year final rule, replacing § 414.1330 with § 414.1335 since § 414.1335 is more specific because it discusses the quality performance category requirements.
We finalized at § 414.1380(b)(1)(vi)(C)(4) that we would compare the 2018 performance to an assumed 2017 quality performance category achievement percent score of 30 percent if a MIPS eligible clinician earned a quality performance category score less than or equal to 30 percent in the previous year (82 FR 53744 through 53745). In the CY 2019 PFS proposed rule, we proposed to continue this policy for the 2019 MIPS performance period and amend § 414.1380(b)(1)(vi)(C)(4), accordingly (83 FR 35955). We proposed to compare the 2019 performance to an assumed 2018 quality performance category achievement percent score of 30 percent.
The following is a summary of the public comments on the proposal and our responses:
After consideration of public comments, we are finalizing the proposal to continue our previously established policy for the 2019 MIPS performance period and amend § 414.1380(b)(1)(vi)(C)(4), accordingly. Specifically, we will compare the 2019 performance to an assumed 2018 quality performance category achievement percent score of 30 percent if a MIPS eligible clinician earned a quality performance category score less than or equal to 30 percent in the previous year.
In the CY 2017 and CY 2018 Quality Payment Program final rules (81 FR 77300 and 82 FR 53747 through 53748, respectively), we finalized the policies on incorporating the improvement percent score into the quality performance category percent score. As part of our technical updates to § 414.1380(b)(1) discussed in section III.I.3.i.(1)(b) of this final rule, our previously established policies are now referenced at § 414.1380(b)(1)(vii).
For a description of the statutory basis and our existing policies for scoring achievement in the cost performance
While we did not receive any public comments for this proposal, we are finalizing our proposal to codify these final policies at § 414.1380(b)(2)(i).
For a description of the statutory basis and our existing policies for scoring improvement in the cost performance category, we refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53749 through 53752). Section 51003(a)(1)(B) of the Bipartisan Budget Act of 2018 modified section 1848(q)(5)(D) of the Act such that the cost performance category score shall not take into account the improvement of the MIPS eligible clinician for each of the second, third, fourth, and fifth years for which the MIPS applies to payments. We do not believe this change requires us to remove our existing methodology for scoring improvement in the cost performance category (see 82 FR 53749 through 53752), but it does prohibit us from including an improvement component in the cost performance category percent score for each of the 2020 through 2023 MIPS payment years. Therefore, we proposed to revise § 414.1380(b)(2)(iv)(E) to provide that the maximum cost improvement score for the 2020, 2021, 2022, and 2023 MIPS payment years is zero percentage points (83 FR 35955). Under our existing policy (82 FR 53751 through 53752), the maximum cost improvement score for the 2020 MIPS payment year is 1 percentage point, but due to the statutory changes and under our proposal, the maximum cost improvement score for the 2020 MIPS payment year would be zero percentage points. We also proposed at § 414.1380(a)(1)(ii) to modify the performance standards to reflect that the cost performance category percent score will not take into account improvement until the 2024 MIPS payment year (83 FR 35956). The following is a summary of the public comments received on these proposals and our responses:
We believe that not scoring clinicians and groups that meet the case minimum for only a single measure would fail to recognize that a single measure, such as total per capita cost, could reflect care provided to a large number of patients.
After consideration of the public comments, we are finalizing as proposed our proposal to revise § 414.1380(b)(2)(iv)(E) to provide that the maximum cost improvement score for the 2020, 2021, 2022, and 2023 MIPS payment years is zero percentage points. We are also finalizing as proposed our proposal at § 414.1380(a)(1)(ii) to modify the performance standards to reflect that the cost performance category percent score will not take into account improvement until the 2024 MIPS payment year.
In the CY 2018 Quality Payment Program final rule, we established a facility-based measurement scoring option for clinicians that meet certain criteria beginning with the 2019 MIPS performance period/2021 MIPS payment year (82 FR 53752 through 53767). We originally proposed a facility-based measurement scoring option for the 2018 MIPS performance period. We did not finalize the policy because we were concerned that we would not have the operational ability to inform clinicians early enough in the 2018 MIPS performance period to allow them to consider the consequences and benefits of participation (82 FR 53755).
In the CY 2018 Quality Payment Program final rule, we limited facility-based reporting to the inpatient hospital in the first year for several reasons,
We did not propose to add additional facility types for facility-based measurement, but we are interested in potentially expanding to other settings in future rulemaking. Therefore, in section III.I.3.i.(1)(d)(vii) of this final rule, we outline several issues on which we requested feedback and would need to be resolved in order to expand this option to a wider group of facility-based clinicians in future years.
In the CY 2018 Quality Payment Program final rule, we established individual eligibility criteria for facility-based measurement at § 414.1380(e)(2)(i). We established that 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 or emergency room based on claims for a period prior to the performance period as specified by CMS (82 FR 53756 through 53757) is eligible as an individual for facility-based measurement. We had noted, as a part of our proposal summary, that we would use the definition of professional services in section 1848(k)(3)(A) of the Act in applying this standard (82 FR 53756). For purposes of determining eligibility for facility-based measurement, we discussed CMS using data from the period between September 1 of the calendar year, 2 years preceding the MIPS performance period, through August 31 of the calendar year preceding the MIPS performance period, with a 30-day claims run out but did not finalize that as part of the applicable regulation (82 FR 53756 through 53757). Because we are using the quality measures associated with the inpatient hospital to determine the MIPS quality and cost performance category score, we wanted to ensure that eligible clinicians contributed to care in that setting during that time period.
We indicated that CMS will use POS code 21 (inpatient) and POS code 23 (emergency department) for this purpose (82 FR 53756). Commenters on our proposal (as summarized in the CY 2018 Quality Payment Program final rule (82 FR 53756 through 53757)) expressed concern that adopting the definition that we did for facility-based clinicians would limit the number of clinicians who would be eligible.
In the CY 2019 PFS proposed rule, we proposed to modify our determination of a facility-based individual at § 414.1380(e)(2)(i) in four ways (83 FR 35957). First, we proposed to add on-campus outpatient hospital (as identified in the POS code in the HIPAA standard transaction, that is, POS code 22) to the settings that determine whether a clinician is facility-based. Second, we proposed that a clinician must have at least a single service billed with the POS code used for the inpatient hospital or emergency room. Third, we proposed that, if we are unable to identify a facility with a value-based purchasing score to attribute as a clinician's performance, that clinician is not eligible for facility-based measurement. Fourth, we proposed to align the time period for determining eligibility for facility-based measurement with changes to the dates used to determine MIPS eligibility and special status detailed in section III.I.3.b. of this final rule. We explain these four proposals from the proposed rule in this section. In the CY 2019 PFS proposed rule, we stated our belief that these proposals will further expand the opportunity for facility-based measurement and eliminate issues associated with the provision of observation services while still restricting eligibility to those who work in an inpatient setting.
First, we proposed to add the on-campus outpatient hospital (POS code 22) to the list of sites of service used to determine eligibility for facility-based measurement (83 FR 35957). We agree with commenters that limiting the eligibility to our current definition may prevent some clinicians who are largely hospital-based from being eligible. However, expanding eligibility without taking into account the relationship between the clinician and the facility and facility's performance could result in unfairly attributing to a clinician performance for which the clinician is not responsible or has little to no role in improving. We do believe that a significant provision of services in the on-campus outpatient hospital are reflected in the quality captured by the Hospital VBP Program. For example, patients in observation status are typically treated by the same staff and clinicians as those who meet the requirements for inpatient status. Although there are some clinical differences that may result in a patient having observation status, we believe that the quality of care provided to these patients in this same setting would be comparable, reflecting the overall healthcare system at that particular location. In the CY 2019 PFS proposed rule, we stated our conviction, based on this that a sufficient nexus exists for attributing the hospital's VBP Total Performance Score to clinicians that provide services in on-campus outpatient hospital settings.
Second, we proposed to require that clinicians bill at least a single service with the POS codes for inpatient hospital or the emergency room in order to be eligible for facility-based measurement (83 FR 35957). Although we generally believe that clinicians who provide services in the outpatient hospital can affect the quality of care for inpatients, we noted in the CY 2019 PFS proposed rule our belief that a clinician who is measured according to the performance of a hospital should at least have a minimal presence in the inpatient or emergency room setting. We explained our concern about attributing inpatient facility performance to clinicians who provide at least 75 percent of their services at on-campus outpatient hospitals (with POS code 22) when such clinicians exclusively provide outpatient services that are unrelated to inpatient hospital service by describing an example: A dermatologist who provides office-based services in a hospital-owned clinic but who never admits or treats patients within the inpatient or emergency room setting does not meaningfully contribute to the quality of care for patients measured under the Hospital VBP Program.
We stated in the CY 2019 PFS proposed rule how we had considered different ways to best identify those who contribute to the quality of care in the inpatient setting while keeping the
We explained in the proposed rule our rationale and reasoning for these first two proposals as being based in large part on our analysis of the previously finalized policy for eligibility for the facility-based measurement scoring option. Using claims data, we had identified all clinicians that would be MIPS eligible as either an individual or group, and identified the POS codes submitted for PFS services provided by those clinicians. We then modeled the existing final policy based on inpatient and ER services. Although almost all ER physicians would be scored under facility-based measurement, a relatively small percentage of clinicians in other specialties, even those which we expected to have significant presence in the hospital, would be eligible for the facility-based measurement scoring option. For example, only 13.45 percent of anesthesiologists would be eligible for the facility-based measurement scoring option under the policy finalized in the CY 2018 Quality Payment Program final rule. Adding the on-campus outpatient hospital POS code substantially increased eligibility for the facility-based measurement scoring option in our modeling, even after we adjusted for requiring one service with the inpatient or emergency department POS. Under our proposal, our model illustrated that 72.55 percent of anesthesiologists would be eligible. However, the model did not show that the proposal would substantially increase the number of clinicians eligible for the facility-based measurement scoring option who, based on specialty identification, may not have a significant presence in the hospital. For example, the modeling of the proposed policy projected an increase in the percentage of family physicians eligible for the facility-based measurement scoring option from 11.34 percent to 13.86 percent, which is still a very small percentage of those clinicians.
Third, we proposed to add a new criterion (to be codified at § 414.1380(e)(2)(i)(C)) that stated to be eligible for facility-based measurement, we must be able to attribute a clinician to a particular facility that has a value-based purchasing score (83 FR 35957 through 35958). We explained in the proposed rule how, for facility-based measurement to be applicable, we must be able to attribute a clinician to a facility with a value-based purchasing score. Based on our definition of facility-based measurement, we stated that this means a clinician must be associated with a hospital with a Hospital VBP Program Total Performance Score. We explained our concern that the proposed expansion of eligibility for facility-based measurement would increase the number of clinicians eligible for facility-based measurement but to whom we would be unable to attribute the performance of a particular facility that has a value-based purchasing score. As we noted in the CY 2018 Quality Payment Program final rule (82 FR 53766), some hospitals do not have a Hospital VBP Program Total Performance Score that could be used to determine a MIPS quality and cost performance category score, such as hospitals in the state of Maryland. Hence, clinicians associated with those hospitals would not be able to use facility-based measurement but could report quality measures through another method and have cost measures calculated if applicable. We explained that, under our proposal, a similar result, although relatively rare, would happen if we could not attribute a clinician identified as facility-based to a specific facility; those clinicians who are identified as facility-based but whom we cannot attribute to a hospital would have to participate in MIPS quality reporting through another method, or they would receive a score of zero in the quality performance category. Therefore, we proposed to add the requirement to § 414.1380(e)(2)(i)(C) that a clinician must be able to be attributed to a particular facility with a value-based purchasing score under the methodology specified in § 414.1380(e)(5) to be eligible for facility-based measurement. The cross-reference to paragraph (e)(5) is to the methodology we also proposed for determining the applicable facility score to be used. Our proposed new regulatory text at § 414.1380(e)(2)(i)(C) addresses both attribution to a facility and the need for that facility to have a value-based purchasing score by conditioning eligibility for facility-based scoring for an individual clinician on the clinician being attributed under the methodology in paragraph (e)(5) to a facility with a value-based purchasing score.
Fourth, we proposed to change the dates of determining eligibility for facility-based measurement (83 FR 35958). In section III.M.3.b. of the proposed rule, we proposed to modify the dates of the MIPS determination period that would provide eligibility determination for small practice size, non-patient facing, low-volume threshold, ASC, hospital-based, and facility-based determination periods. To align this regulation controlling facility-based scoring with these other determination periods, we proposed that CMS would use data from the initial 12-month segment beginning on October 1 of the calendar year 2 years prior to the applicable performance period and ending on September 30 of the calendar year preceding the applicable performance period, with a 30-day claims run out, in determining eligibility for facility-based measurement.
The following is a summary of the public comments received on these proposals and our responses:
While the measures used in the Hospital Outpatient Quality Reporting Program do reflect quality for the off-campus outpatient hospital, section 1848(q)(2)(C)(ii) of the Act provides that we may not use measures for hospital outpatient departments, except in the case of items and services furnished by emergency physicians, radiologists, and anesthesiologists. Our determination of facility-based measurement does not consider the specialty of clinicians, so we therefore do not believe it is appropriate or consistent with the statutory authority to add this setting or these measures at this time.
After consideration of the public comments, we are finalizing our proposals to add the on-campus outpatient hospital (POS code 22) to the list of sites of service used to determine eligibility for facility-based measurement and to require that clinicians bill at least a single service with the POS codes for inpatient hospital or the emergency room in order to be eligible for facility-based measurement as reflected in the regulation text at § 414.1380(e)(2)(i)(A) and (B). We are also finalizing our proposal that we must be able to attribute a clinician to a particular facility that has a value-based purchasing score under the methodology specified in § 414.1380(e)(5) to meet eligibility for facility-based measurement as codified at § 414.1380(e)(2)(i)(C). We are also finalizing our proposed policy that CMS would use data from the initial 12-month segment beginning on October 1 of the calendar year 2 years prior to the applicable performance period and ending on September 30 of the calendar year preceding the applicable performance period, with a 30-day claims run out to determine eligibility for facility-based measurement.
In the CY 2018 Quality Payment Program final rule (82 FR 53757), we finalized at § 414.1380(e)(2)(ii) that a MIPS eligible clinician is eligible for facility-based measurement under MIPS if they are determined to be facility-based as part of a group. We established at § 414.1380(e)(2)(ii) that a facility-based group is a group in which 75 percent or more of its eligible clinician NPIs billing under the group's TIN meet the requirements at § 414.1380(e)(2)(i) (82 FR 53758). We did not propose any changes to the determination of a facility-based group but acknowledged that our proposal to change how individual clinicians are determined to be eligible for facility-based measurement will necessarily have a practical impact for practice groups. For more of the statutory background and descriptions of our current policies on determining a facility-based group, we refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53757 through 53758).
In the CY 2018 Quality Payment Program final rule (82 FR 53759), we finalized at § 414.1380(e)(5) a method to identify the hospital whose scores would be associated with a MIPS eligible clinician or group for purposes of facility-based measurement scoring. However, because of a discrepancy in the preamble and the proposed regulation text in the CY 2018 Quality Payment Program proposed rule (82 FR 53759), we indicated we would address this issue as part of the next Quality Payment Program rulemaking cycle. Under the current regulation text § 414.1380(e)(5), a facility-based clinician or group receives a score under the facility-based measurement scoring standard derived from the value-based purchasing score for the facility at which the clinician or group provided services to the most Medicare beneficiaries during the year claims are drawn (that is, the 12-month period described in paragraph (e)(2)). Although we did not propose any changes, we are revising this section to replace the word “segment” with “period” for clarity purposes.
If an equal number of Medicare beneficiaries are treated at more than one facility, then we will use the value-based purchasing score for the highest-scoring facility (82 FR 53759 through 53760). For more of the statutory background and descriptions of our current policies for attributing a facility to a MIPS eligible clinician, we refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53759 through 53760).
In considering the issue of facility attribution for a facility-based group, we stated in the CY 2019 PFS proposed rule that we believe that a change to facility-based attribution is appropriate to better align the policy with the determination of a facility-based group at § 414.1380(e)(2)(ii). A facility-based group is one in which 75 percent or more of the eligible clinician NPIs billing under the group's TIN are eligible for facility-based measurement as individuals. Additionally, under the current regulation, the value-based purchasing score for the highest scoring facility would be used in the case of a tie among the number of facilities at which the group provided services to Medicare beneficiaries. We proposed to revise § 414.1380(e)(5) to differentiate how a facility-based clinician or group receives a score based on whether they participate as a clinician or a group (83 FR 35958).
We proposed to remove “or group” from § 414.1380(e)(5) and redesignate that paragraph as (e)(5)(i) so that it only applies to individual MIPS eligible clinicians (83 FR 35958). Under our proposal, newly redesignated paragraph (e)(5)(i) would retain the rule for facility attribution for an individual MIPS eligible clinician as finalized in the CY 2018 Quality Payment Program final rule; we also proposed a few minor edits to the paragraph for grammar and to improve the sentence flow. We also proposed to add a new paragraph (e)(5)(ii) to provide that a facility-based group receives a score under the facility-based measurement scoring standard derived from the value-based purchasing score for the facility at which the plurality of clinicians identified as facility-based would have had their score determined under the methodology described in § 414.1380(e)(5)(i) if the clinicians had been scored under facility-based measurement as individuals (83 FR 35958). We made this proposal because of our wish to emphasize the connection between an individual clinician and a facility. We explained in the CY 2019 PFS proposed rule that using the plurality of clinicians reinforces the connection between an individual clinician and facility and is more easily understandable for larger groups.
The following is a summary of the public comments received on these proposals and our responses:
We understand that some groups that may be facility-based include clinicians that practice in a number of different facilities. However, we believe this issue is similar to that experienced in other clinician groups that may have a diversity of clinicians and settings. In section III.I.3.e of the proposed rule (83 FR 35891), we requested comments on developing an opportunity for clinicians to participate in MIPS as subgroups. We believe that our consideration of that issue could inform the determination of members of a group that practice in a single TIN but who serve patients in many different facilities.
After consideration of the public comments, we are finalizing our proposals to remove “or group” from § 414.1380(e)(5); redesignate that paragraph as (e)(5)(i) so that it only applies to individual MIPS eligible clinicians; and add a new paragraph (e)(5)(ii) to § 414.1380(e)(5) regarding group scoring methodologies in which a facility-based group receives a score under the facility-based measurement scoring standard derived from the value-based purchasing score for the facility at which the plurality of clinicians identified as facility-based would have had their score determined under the methodology described in § 414.1380(e)(5)(i) if the clinicians had been scored under facility-based measurement as individuals.
In the CY 2018 Quality Payment Program final rule (82 FR 53760), we did not finalize our proposal for how individual MIPS eligible clinicians or groups who wish to have their quality and cost performance category scores determined based on a facility's performance would elect to do so through an attestation. We did finalize, and reflect in the introductory text at § 414.1380(e), that an individual clinician or group would elect to use a facility-based score. In the CY 2019 PFS proposed rule (82 FR 53760), we specified that such clinicians or groups would be required to submit their election during the data submission period through the attestation submission mechanism established for the improvement activities and the Promoting Interoperability performance categories. An alternative approach, which likewise was not finalized, did not require an election process, but instead would have automatically applied a facility-based measurement to MIPS eligible clinicians and groups who met the eligibility criteria for facility-based measurement, if such an application were technically feasible (82 FR 53760). We noted in the CY 2018 Quality Payment Program final rule (82 FR 53760) that we would examine both the attestation process and the opt-out process, and work with stakeholders to identify a new proposal in future rulemaking. We explained in the CY2018 Quality Payment Program final rule (82 FR 53760) our interest in a process that would impose less burden on clinicians than an attestation requirement and requested comment on automatically assigning a clinician or group a facility-based score, but with a notice and opportunity to opt-out of facility-based measurement. We summarized those comments in the CY 2019 PFS proposed rule (83 FR 35958).
After further considering the advantages and disadvantages of an opt-in or an opt-out process, we proposed a modified policy that would not require an election process. We proposed to automatically apply facility-based measurement to MIPS eligible clinicians and groups who are eligible for facility-based measurement and who would benefit by having a higher combined quality and cost performance category score (83 FR 35959). Under our proposal, if the MIPS eligible clinician or group is eligible for facility-based measurement, we would calculate a combined quality and cost performance category score. We proposed to use the facility-based score to determine the MIPS quality and cost performance category scores, unless we received another submission of quality data for or on behalf of that clinician or group and the combined quality and cost performance category score for the other submission results in a higher combined quality and cost performance score. If the other submission has a higher combined quality and cost performance score, then we would not apply the facility-based performance scores for either the quality or cost performance categories (83 FR 35959). Under our proposal, the combined score for the quality and cost performance categories would determine the scores to be used for both the quality and cost performance categories, for both individual clinicians and for groups that meet the requirements of paragraph (e)(2). We did not propose to adopt a formal opt-out process because, under our proposal, the higher of the combined quality and cost performance scores for the clinician or clinician group would be used, which would only benefit the clinician or group. We explained in the proposed rule our strong commitment to reducing burden as part of the Quality Payment Program and that we believe that requiring a clinician or group to elect a measurement process (or to opt-out of a measurement process) based on facility performance would add unnecessary burden.
In MIPS, we score clinicians as individuals unless they submit data as a group. We stated in the proposed rule that the same policy should apply to facility-based measurement, even though there are no submission requirements for the quality performance category for individuals under facility-based measurement. We proposed to revise § 414.1380(e)(4) to state that there are no submission requirements for individual clinicians in facility-based measurement, but a group must submit data in the improvement activities or Promoting Interoperability performance categories in order to be measured as a group under facility-based measurement. We explained how, if a group does not
In the CY 2018 Quality Payment Program final rule, we established that if a clinician or group elects facility-based measurement but also submits MIPS quality data, then the clinician or group would be measured on the method that results in the higher quality score (82 FR 53767). We proposed to adopt this same scoring principle in conjunction with our proposal not to use (or require) an election process. Therefore, we proposed at § 414.1380(e)(6)(vi) that the MIPS quality and cost score for clinicians and groups eligible for facility-based measurement would be based on the facility-based measurement scoring methodology described in § 414.1380(e)(6) unless the clinician or group receives a higher combined score for the MIPS quality and cost performance categories through data submitted to CMS for MIPS (83 FR 35959). We stated in the proposed rule that this policy is not applicable to any MIPS eligible clinicians scored under the APM scoring standard described at § 414.1370; we further clarify here that this includes Shared Savings Program participant TINs in ACOs that have failed to complete web interface reporting, unless these measures are specifically required under the terms of the applicable APM.
We also proposed conforming changes in two other sections of regulatory text. We proposed to revise the introductory text at § 414.1380(e) to remove “elect to,” and therefore, reflect that clinicians and groups who are determined to be facility-based will receive MIPS quality and cost performance categories under the methodology in paragraph (e) (83 FR 35959 through 35960). Because of our proposal to not require clinicians to opt-in into facility-based measurement, we acknowledged that there may be clinicians that will continue to submit data via other methods. We explained that these clinicians and groups are not prohibited from submitting quality measures to CMS for purposes of MIPS. However, under our proposal, if a higher combined quality and cost score is achieved using data submitted to CMS for purposes of MIPS, then we will use the MIPS scores based on the submission. We also proposed to revise § 414.1380(e)(4) and (e)(6)(v)(A) to reflect that facility-based measurement does not require election and to replace the phrase “clinicians that elect facility-based measurement” with “clinicians and groups scored under facility-based measurement” (83 FR 35960) as part of this policy.
The following is a summary of the public comments received on these proposals and our responses:
After consideration of the public comments, we are finalizing our proposal to automatically apply facility-based measurement to MIPS eligible clinicians and groups who are eligible for facility-based measurement and those who have a higher combined quality and cost performance category score. Additionally, we are finalizing our proposal to revise § 414.1380(e)(4) to state that there are no submission requirements for individual clinicians in facility-based measurement and that a group must submit data in the improvement activities or Promoting Interoperability performance categories to be measured as a group under facility-based measurement. Additionally, we are also revising the proposed regulation text for § 414.1380(e)(4) by adding “to be” between “clinicians” and “scored” to clarify that this paragraph is establishing the data submissions necessary for facility-based scoring to be possible as opposed to a provision governing MIPS reporting as a whole for all categories. We are also finalizing the conforming changes at § 414.1380(e)(4) and (e)(6) to revise text that referred to an election by the clinician or group to use facility-based scoring. Additionally, while we did not propose any changes, we are revising § 414.1380(e) to state, for the payment in 2021 MIPS payment year and subsequent years and subject to paragraph (e)(6)(vi) of this section, a MIPS eligible clinician or group will be scored under the quality and cost performance categories under the methodology described in this paragraph (e). These technical changes are made to conform to our policy in this section to not require or offer an election and to improve readability.
Section 1848(q)(2)(C)(ii) of the Act provides that the Secretary may use
We did finalize a facility-based measurement scoring standard but not the specific instance of using the FY 2019 Hospital VBP Program Total Performance Score methodology (82 FR 53755). We expressed our belief that using all measures from the Hospital VBP Program is appropriate; nevertheless, because we did not finalize the facility-based measurement scoring option for the 2018 MIPS performance period/2020 MIPS payment year, it was not appropriate to adopt these policies at that time (82 FR 53762 through 53763). We noted that we intended to propose measures that would be available for facility-based measurement for the 2019 MIPS performance period/2021 MIPS payment year in future rulemaking (82 FR 53763).
As we noted in the proposed CY 2019 PFS rule, we continue to believe it is appropriate to adopt all the measures for the Hospital VBP Program into MIPS for purposes of facility-based scoring; these Hospital VBP Program measures meet the definition of additional system-based measures provided in section 1848(q)(2)(C)(ii) of the Act. We also stated how it is appropriate to adopt the performance periods for the measures, which generally are consistent with the dates that we use to determine eligibility for facility-based measurement.
Beginning with the 2019 MIPS performance period, we proposed at § 414.1380(e)(1)(i) to adopt for facility-based measurement, the measure set that we finalize for the fiscal year Hospital VBP Program for which payment begins during the applicable MIPS performance period. For the 2019 MIPS performance period (which runs on the 2019 calendar year), we proposed to adopt the FY 2020 Hospital VBP Program measure set, for which payment begins on October 1, 2019. The performance period for these measures varies but performance ends in 2018 for all measures.
We also proposed at § 414.1380(e)(1)(ii) that, starting with the 2021 MIPS payment year, the scoring methodology applicable for MIPS eligible clinicians scored with facility-based measurement is the Total Performance Score methodology adopted for the Hospital VBP Program, for the fiscal year for which payment begins during the applicable MIPS performance period. Additionally, we note a typographical error in the CY 2019 PFS proposed rule (83 FR 35960) in which we state FY 2019 instead of FY 2020, which we believe commenters have likely understood given the comments we have received on FY 2020 measures. However, we provide additional clarification in this final rule.
We noted in the proposed rule that this approach of adopting all the measures in the Hospital VBP Program can be applied to other value-based purchasing programs in the future, should we decide to expand facility-based measurement to settings other than hospitals.
In the CY 2018 Quality Payment Program final rule we also established at § 414.1380(e)(6)(i) that the available quality and cost measures for facility-based measurement are those adopted under the value-based purchasing program of the facility for the year specified. We established at § 414.1380(e)(6)(ii) that we will use the benchmarks adopted under the value-based purchasing program of the facility program for the year specified (82 FR 53763 through 53764). We noted that we would determine the particular value-based purchasing program to be used for facility-based measurement in future rulemaking but would routinely use the benchmarks associated with that program (82 FR 53764). Likewise, at § 414.1380(e)(6)(iii), we established that the performance period for facility-based measurement is the performance period for the measures adopted under the value-based purchasing program of the facility program for the year specified (82 FR 53755). We noted that these provisions referred to the general parameters of our method of facility-based measurement and that we would address specific programs and years in future rulemaking (82 FR 53763). For the CY 2019 performance period, we proposed regulation text for these three provisions to specify that the measures, performance period, and benchmark period for facility-based measurement are the measures, performance period, and benchmark period established for the value-based purchasing program used to determine the score as described in § 414.1380(e)(1) (83 FR 35960). We provided an example in the proposed rule to illustrate this policy: For the 2019 MIPS performance period and 2021 MIPS payment year, the measures used would be those for the FY 2019 Hospital VBP Program along with the associated benchmarks and performance periods. As explained earlier, we intended this to mean that for the 2019 MIPS performance period and 2021 MIPS payment year, the measures used would be those for the FY 2020 Hospital VBP Program along with the associated benchmarks and performance periods.
The following is a summary of the public comments received on these proposals and our responses:
After consideration of the public comments, we are finalizing the proposed regulation text at § 414.1380(e)(1)(i) that the measures for facility-based measurement will be the measure set finalized for the fiscal year value-based purchasing program for which payment begins during the applicable MIPS performance period. We are also finalizing the proposed regulation text at § 414.1380(e)(1)(ii) that, beginning with the 2021 MIPS payment year, the scoring methodology applicable for MIPS eligible clinicians scored with facility-based measurement is the Total Performance Score methodology adopted for the Hospital VBP Program for the fiscal year for which payment begins during the applicable MIPS performance period. This means that for the 2021 MIPS payment year, the Total Performance Score for FY 2020 will be applied for the MIPS performance year 2019. Additionally, while we did not propose any changes, we are revising the regulation text at § 414.1380(e)(1)(i) to stated that the measures used for facility-based measurement are the measure set finalized for the fiscal year VBP program for which payment begins during the applicable MIPS performance period. This update is not intended to be substantive in nature, but rather to bring more clarity to the regulatory text. We have also made a technical revision in which we revise § 414.1380(e)(6)(ii), (iv), and (v) to reference only (e)(1) rather than (e)(1)(i) for improvements in readability and clarity of the regulation.
For informational purposes, we provided a list of measures included in the FY 2020 Hospital VBP Program that would be used in determining the quality and cost performance category scores for the 2019 MIPS performance period/2021 MIPS payment year. The FY 2020 Hospital VBP Program has adopted 12 measures covering 4 domains (83 FR 20412 through 20413). The performance period for measures in the Hospital VBP Program varies depending on the measure, and some measures include multi-year performance periods. We noted in the proposed rule that these measures are determined through separate rulemaking (83 FR 38244); the applicable rulemaking is usually the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System rule. We are using these measures, benchmarks, and performance periods for the purposes of facility-based measurement based on § 414.1380(e)(1) as finalized here. We repeat the list of measures finalized for the FY 2020 Hospital VBP measure set and Total Performance Score in Table 52.
In the CY 2018 Quality Payment Program final rule, we adopted certain scoring policies for clinicians and groups in facility-based measurement. We established at § 414.1380(e)(6)(iv) and (v) that the quality and cost performance category percent scores would be established by determining the percentile performance of the facility in the value-based purchasing program for the specified year, then awarding scores associated with that same percentile performance in the MIPS quality and cost performance categories for those MIPS eligible clinicians who are not scored using facility-based measurement for the MIPS payment year (82 FR 53764). We also finalized at § 414.1380(e)(6)(v)(A) that clinicians scored under facility-based measurement would not be scored on other cost measures (82 FR 53767).
For detailed descriptions of the current policies related to scoring achievement in facility-based measurement, we refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53763). Because we proposed to not require or allow an opt-in process for facility-based measurement, we proposed a change to the determination of the quality and cost performance category scores. We proposed that the quality and cost performance category percent scores would be established by determining the percentile performance of the facility in the Hospital VBP Program for the specified year, then awarding a score associated with that same percentile performance in the MIPS quality and cost performance categories for those MIPS eligible clinicians who are not eligible to be scored under facility-based measurement for the MIPS payment year (83 FR 35961). Under our proposal, the determination of percentile performance would be independent of those clinicians who would not have their quality or cost scores determined until we make the determination of their status under facility-based measurement.
The following is a summary of the public comments received on these proposals and our responses:
After consideration of the public comments, we are finalizing our proposal to change the determination of the quality and cost performance category scores at § 414.1380(e)(6)(iv) and (v) to establish both scores by determining the percentile performance of the facility in value-based purchasing program for the specified year, then awarding a score associated with that same percentile performance in the MIPS quality and cost performance categories for those MIPS eligible clinicians who are not eligible to be scored under facility-based measurement for the MIPS payment year. Also, we have revised the last sentence in paragraphs (e)(6)(iv) and (v) to more clearly state that a clinician or group receiving a facility-based performance score will not earn improvement points based on prior performance in the MIPS quality or cost categories.
In the CY 2018 Quality Payment Program final rule, we finalized that we would not give a clinician or group participating in facility-based measurement the opportunity to earn improvement points based on prior performance in the MIPS quality and cost performance categories; we noted that the Hospital VBP Program already takes improvement into account in determining the Total Performance Score (82 FR 53764 through 53765). We proposed to add this previously finalized policy to regulatory text at § 414.1380(e)(6)(iv) and (v) (83 FR 35961).
We did not address in the CY 2018 Quality Payment Program final rule a policy for a clinician or group who participates in facility-based measurement for one performance period, and then does not participate in facility-based measurement in a subsequent performance period (for example, a clinician who is scored using facility-based measurement in the 2019 MIPS performance period and is not eligible for facility-based measurement in the 2020 MIPS performance period). After further considering the issue, we stated in the CY 2019 PFS proposed rule our position that it is not possible to assess improvement in the quality performance category for those who are measured under facility-based measurement in 1 year and then through another method in the following year. Our method of assessing and rewarding improvement in the MIPS quality performance category separates points awarded for measure performance from those received for bonus points (82 FR 53745). Our method of determining the quality performance category score using facility-based measurement does not allow for the separation of achievement from bonus points. For this reason, we proposed at § 414.1380(b)(1)(vi)(A)(4)
We did not receive any public comments on this proposal, so we will finalize our proposal to add regulatory text at § 414.1380(e)(6)(iv) and (v) and our proposal at § 414.1380(b)(1)(vi)(A)(4) to not assess improvement for MIPS-eligible clinicians who are scored in MIPS through facility-based measurement in 1 year but through another method in the following year.
We initiated the process of facility-based measurement focusing on the inpatient hospital setting, but have noted in the past our policy goal of expanding the concept into other facilities and programs and future, in particular to use the post-acute care (PAC) and the end-stage renal disease (ESRD) settings as the basis for facility-based measurement and scoring. In the proposed rule, we summarized a number of issues and topics related to the use of PAC and ESRD facilities (83 FR 35962 through 35963). We solicited comment on these topics, including:
• How to attribute the quality and cost of care for patients in PAC settings to clinicians;
• Whether using a value-based purchasing program, that is, a similar approach to § 414.1380(e)(1), could work for PAC given the number and variation of PAC settings and clinicians;
• The level of influence MIPS-eligible clinicians have in determining performance on quality measures for individual settings and programs in the PAC setting;
• Which PAC QRP measures may be best utilized to measure clinician performance;
• Methods to identify the appropriate measures for scoring, and what measures would be most influenced by clinicians;
• Whether all measures that are reported as part of the PAC QRPs should be included or whether we should identify a subset of measures;
• Whether we should limit facility-based measurement to specific PAC settings and programs such as the IRF QRP or LTCH QRP, or whether we should consider all PAC settings in the facility-based measurement discussion;
• The extent to which the quality measures of dialysis centers reflect clinician performance; and
• Practical and policy considerations related to whether we could to attribute the performance of a specific ESRD facility to an individual clinician.
We appreciate the comments received in response to these considerations and may consider these suggestions in policies that will be proposed as part of future rulemaking.
For our previously established policies regarding scoring the improvement activities performance category, we refer readers to § 414.1380(b)(3) and the CY 2018 Quality Payment Program final rule (82 FR 53767 through 53769). We also refer readers to § 414.1355 and the CY 2018 Quality Payment Program final rule (82 FR 53648 through 53662) and CY 2017 Quality Payment Program final rule (81 FR 77177 through 77199) for previously established policies regarding the improvement activities performance category generally.
In the CY 2019 PFS proposed rule, we proposed updates to both §§ 414.1380(b)(3) and 414.1355 to more clearly and concisely capture previously established policies (83 FR 35963). We also proposed one substantive change with respect to patient-centered medical homes and comparable specialty practices (83 FR 35963). These are discussed in more detail in this section.
In an effort to more clearly and concisely capture previously established policies, we proposed updates to § 414.1380(b)(3) and refer readers to the CY 2019 PFS proposed rule for more details (83 FR 35963). We also clarified that the improvement activities performance category score cannot exceed 100 percent (83 FR 35963).
We solicited comments on the above proposal. We did not receive any comments on this proposal. We are finalizing our changes to regulation text at § 414.1380(b)(3) as proposed.
In an effort to more clearly and concisely capture previously established policies, we proposed updates to § 414.1380(b)(3) and refer readers to the CY 2019 PFS proposed rule for more details (83 FR 35963).
We solicited comments on the above proposal. We did not receive any comments on this proposal. We are finalizing our changes to regulation text at § 414.1380(b)(3) as proposed.
In an effort to more clearly and concisely capture previously established policies, we proposed updates to § 414.1380(b)(3)(i) and refer readers to the CY 2019 PFS proposed rule for more details (83 FR 35963).
We solicited comments on the above proposal. We did not receive any comments on this proposal. We are finalizing our changes to regulation text at § 414.1380(b)(3)(i) as proposed.
In the CY 2019 PFS proposed rule (83 FR 35963), we proposed to modify our regulations at § 414.1380(b)(3)(ii) to more clearly and concisely capture our previously established policies for patient-centered medical homes and comparable specialty practices and refer readers to the CY 2019 PFS proposed rule for more details.
In addition, it had come to our attention that in the preamble of the CY 2017 Quality Payment Program final rule (81 FR 77186 and 77179), the terminology “automatic” was used in reference to patient-centered medical home or comparable specialty practice improvement activities scoring credit. In that rule (81 FR 77186), in response to one comment, we stated, “. . . any MIPS eligible clinician or group that does not qualify by October 1st of the performance year as a certified patient-centered medical home or comparable specialty practice cannot receive automatic credit as such for the improvement activities performance category.” In response to another comment in that rule (81 FR 77179), we stated, “Other certifications that are not for patient-centered medical homes or comparable specialty practices would also not qualify automatically for the highest score.”
While we used the term “automatic” then, we have since come to realize it is inaccurate because an eligible clinician or group must attest to their status as a patient-centered medical home or comparable specialty practice in order to receive full credit for the improvement activities performance category. In the CY 2018 Quality Payment Program final rule (82 FR 53649), in response to comments we received regarding patient-centered medical homes or comparable specialty practices receiving full credit for the improvement activities performance category for MIPS, we stated that we would like to make clear that credit is not automatically granted; MIPS eligible clinicians and groups must attest in order to receive the credit.
Therefore, in the CY 2019 PFS proposed rule (83 FR 35963), we proposed codifying at § 414.1380(b)(3)(ii) to require that an eligible clinician or group must attest to their status as a patient-centered medical home or comparable specialty practice in order to receive this credit. Specifically, MIPS eligible clinicians who wish to claim this status for purposes of receiving full credit in the improvement activities performance category must attest to their status as a patient-centered medical home or comparable specialty practice for a continuous 90-day minimum during the performance period.
We solicited comments on the above proposal. We received the following comment on this proposal.
After consideration of the comment we received, we are finalizing our changes to regulation text at § 414.1380(b)(3)(ii) as proposed.
In the CY 2019 PFS proposed rule (83 FR 35963), in an effort to more clearly and concisely capture previously established policies, we proposed to make technical changes to § 414.1355(b) to state that unless a different scoring weight is assigned by CMS under section 1848(q)(5)(F) of the Act, performance in the improvement activities performance category comprises 15 percent of a MIPS eligible clinician's final score for the 2019 MIPS payment year and for each MIPS payment year thereafter). We stated that we believe these changes would better align the regulation text with the text of the statute.
We solicited comments on the above proposal. We did not receive any comments on this proposal. We are finalizing our changes to regulation text at § 414.1355(b) as proposed.
In the CY 2017 Quality Payment Program final rule (81 FR 77202 through 77209) and the CY 2018 Quality Payment Program final rule (82 FR 53664 through 53670), we established that certain activities in the improvement activities performance category will qualify for a bonus under the Promoting Interoperability performance category if they are completed using CEHRT. This bonus is applied under the Promoting Interoperability performance category and not under the improvement activities performance category. In the CY 2019 PFS proposed rule (83 FR 35932), we proposed a new approach for scoring the Promoting Interoperability performance category that is aligned with our MIPS program goals of flexibility and simplicity. We refer readers to section III.I.3.h.(5)(g) of this final rule for a summary of the comments we received regarding this proposal and our responses.
We refer readers to section III.I.3.h.(5) of this final rule, where we discuss our proposals for scoring the Promoting Interoperability 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 § 414.1380(c), the discussion in the CY 2017 Quality Payment Program final rule (81 FR 77319 through 77329), and the discussion in the CY 2018 Quality Payment Program final rule (82 FR 53769 through 53785). In this final rule, we discuss our proposal to continue the complex patient bonus for the 2021 MIPS payment year, as well as a
Section 1848(q)(1)(G) of the Act requires us to consider risk factors in our scoring methodology. Specifically, it 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 MIPS. In doing so, the Secretary is required to take into account the relevant studies conducted under section 2(d) of the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act) and, as appropriate, other information, including information collected before completion of such studies and recommendations.
In the CY 2019 PFS proposed rule (83 FR 35964), we summarized our efforts related to social risk and the relevant studies conducted under section 2(d) of the IMPACT Act. We received several comments suggesting various approaches to adjust for social risk factors in the Quality Payment Program going forward. We thank commenters for their input and will take this input into consideration in future years. We also plan to continue working with ASPE, the public, and other key stakeholders on this important issue to identify policy solutions that achieve the goals of attaining health equity for all beneficiaries and minimizing unintended consequences.
In the CY 2018 Quality Payment Program final rule, under the authority in section 1848(q)(1)(G) of the Act, we finalized at § 414.1380(c)(3) a complex patient bonus of up to 5 points to be added to the final score for the 2020 MIPS payment year (82 FR 53771 through 53776). We intended for this bonus to serve as a short-term strategy to address the impact patient complexity may have on MIPS scoring while we continue to work with stakeholders on methods to account for patient risk factors. Our overall goal for the complex patient bonus was 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 noted that we would assess on an annual basis whether to continue the bonus and how the bonus should be structured (82 FR 53771). For a detailed description of the complex patient bonus finalized for the 2020 MIPS payment year, please refer to the CY 2018 Quality Payment Program final rule (82 FR 53771 through 53776).
For the 2019 MIPS performance period/2021 MIPS payment year, we proposed in the CY 2019 PFS proposed rule to continue the complex patient bonus as finalized for the 2018 MIPS performance period/2020 MIPS payment year and to revise § 414.1380(c)(3) to reflect this policy (83 FR 35964 through 35965). Although we intended to maintain the complex patient bonus as a short-term solution, we did not believe we had sufficient information available at the time of the proposed rule to develop a long-term solution to account for patient risk factors in MIPS such that we would be able to propose a different approach for the 2019 MIPS performance period/2021 MIPS payment year. At the time of the proposed rule, we did not believe additional data sources were available that would be feasible to use as the basis for a different approach to account for patient risk factors in MIPS. In the CY 2019 PFS proposed rule, we noted our intention to analyze data when feasible from the 2017 MIPS performance period to identify differences in performance that are consistent across performance categories and that we may, in the future, shift the complex patient bonus to specific performance categories (83 FR 35965). In the absence of data analysis from the first year of MIPS, we did not believe that a change was appropriate at that time. Therefore, we stated that while we work with stakeholders to identify a long-term approach to account for patient risk factors in MIPS, we believed it was appropriate to continue the complex patient bonus for another year to support MIPS eligible clinicians who treat patients with risk factors, as well as to maintain consistency with the 2020 MIPS payment year and minimize confusion. We had received significant feedback from MIPS eligible clinicians that consistency in the MIPS program over time is valued when possible in order to minimize confusion and to help MIPS eligible clinicians predict how they will be scored under MIPS. Therefore, we stated our belief that it is appropriate to maintain consistent policies for the complex patient bonus in the 2021 MIPS payment year until we have sufficient evidence and new data sources that support an updated approach to account for patient risk factors.
Although we did not propose changes to the complex patient bonus for the 2021 MIPS payment year, we stated that the dates used in the calculation of the complex patient bonus may change as a result of other proposals we made in the CY 2019 PFS proposed rule (83 FR 35885 through 35886). For the 2020 MIPS payment year, we finalized that we will use the second 12-month segment of the eligibility determination period to calculate average HCC risk scores and the proportion of full benefit or partial benefit dual eligible beneficiaries for MIPS eligible clinicians (82 FR 53771 through 53772). We proposed to change the dates of the eligibility determination period (now referred to as the MIPS determination period) beginning with the 2021 MIPS payment year (83 FR 35885 through 35886). Specifically, the second 12-month segment would begin on October 1 of the calendar year preceding the applicable performance period and end on September 30 of the calendar year in which the applicable performance period occurs. We indicated that if this proposed change to the MIPS determination period is finalized, then beginning with the 2021 MIPS payment year, the second 12-month segment of the MIPS determination period (beginning on October 1 of the calendar year preceding the applicable performance period and ending on September 30 of the calendar year in which the applicable performance period occurs) would be used when calculating average HCC risk scores and proportion of full benefit or partial benefit dual eligible beneficiaries for MIPS eligible clinicians.
We solicited comments on the above proposals. These comments and our responses are discussed below.
After consideration of public comments, we are finalizing our proposal to continue the complex patient bonus for the 2019 MIPS performance period/2021 MIPS payment year as proposed. We are also finalizing the changes to the regulation text at § 414.1380(c)(3) as proposed. We are also modifying the timing used to calculate the complex patient bonus based on our changes to the MIPS determination period finalized in III.I.3.b. of this final rule. The second 12-month segment of the MIPS determination period will be used when calculating average HCC risk scores and the proportion of full benefit or partial benefit dual eligible beneficiaries for MIPS eligible clinicians.
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 Promoting Interoperability (formerly advancing care information) performance category; and 15 percent for the improvement activities performance category. For more of the statutory background and descriptions of our current policies, we refer readers to the CY 2017 and CY 2018 Quality Payment Program final rules (81 FR 77320 and 82 FR 53779, respectively). Under the proposals we are finalizing in sections III.I.3.h.(3)(a) and III.I.3.h.(2)(a)(ii) of this final rule, for the 2021 MIPS payment year, the cost performance category will make up 15 percent and the quality performance category will make up 45 percent of a MIPS eligible clinician's final score. Table 53 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 to the type of MIPS eligible clinician involved and for each measure and activity with respect to each performance category based on the extent to which the measure or activity is applicable and available to the type of MIPS eligible clinician involved. Under section 1848(q)(5)(B)(i) of the Act, in the case of a MIPS eligible clinician who fails to report on an applicable measure or activity that is required to be reported by the clinician, the clinician must be treated as
In the CY 2017 and CY 2018 Quality Payment Program final rules (81 FR 77322 through 77325 and 82 FR 53779 through 53780, respectively), we explained our interpretation of what it means for there to be sufficient measures applicable and available for the quality and cost performance categories, and we finalized policies for the 2019 and 2020 MIPS payment years under which we would assign a scoring weight of zero percent to the quality or cost performance category and redistribute its weight to the other performance categories in the event there are not sufficient measures applicable and available, as authorized by section 1848(q)(5)(F) of the Act. For the quality performance category, we stated 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 clinician (82 FR 53780). For the cost performance category, we stated 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 (82 FR 53780). We established that if a MIPS eligible clinician is not attributed enough cases for a cost measure (in other words, has not met the required case minimum for the measure), or if a cost measure does not have a benchmark, then the measure will not be scored for that clinician (81 FR 77323). We stated that 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 (82 FR 53780).
In the CY 2019 PFS proposed rule, we proposed to codify these policies for the quality and cost performance categories at § 414.1380(c)(2)(i)(A)(1) and (2), respectively, and to continue them for the 2021 MIPS payment year and each subsequent MIPS payment year (83 FR 35966).
For the Promoting Interoperability performance category, in the CY 2017 Quality Payment Program final rule (81 FR 77238 through 77245) and the CY 2018 Quality Payment Program final rule (82 FR 53680 through 53687), we established policies for assigning a scoring weight of zero percent to the Promoting Interoperability performance category and redistributing its weight to the other performance categories in the final score. We proposed to codify those policies under § 414.1380(c)(2)(i) and (iii) (83 FR 35966).
For the improvement activities performance category, we stated in the CY 2019 proposed rule (83 FR 35967 through 35968) that we continue to believe that all MIPS eligible clinicians will have sufficient activities applicable and available, except for limited extreme and uncontrollable circumstances, such as natural disasters, where a clinician is unable to report improvement activities, and circumstances where a MIPS eligible clinician joins a practice in the final 3 months of the performance period as discussed in the CY 2019 PFS proposed rule (83 FR 35967 through 35968). We stated that, barring these circumstances, we believe that all MIPS eligible clinicians will have sufficient improvement activities applicable and available (82 FR 53780).
We solicited comments on the above proposals. These comments and our responses are discussed below.
After consideration of public comments, we are finalizing our proposal to codify the reweighting policies for the quality and cost performance categories at § 414.1380(c)(2)(i)(A)(1) and (2), respectively, and to continue them for the 2021 MIPS payment year and each subsequent MIPS payment year, as proposed. We are also finalizing our proposal to codify the Promoting Interoperability reweighting policies under § 414.1380(c)(2)(i) and (iii) as proposed.
For a summary of the final policy we adopted beginning with the 2018 MIPS performance period/2020 MIPS payment year to reweight the quality, cost, and improvement activities performance categories based on a request submitted by a MIPS eligible clinician, group, or virtual group that was subject to extreme and uncontrollable circumstances, we refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53780 through 53783). In the proposed rule (83 FR 35966), we proposed to codify this policy at § 414.1380(c)(2)(i)(A)(
We proposed a few minor modifications to our extreme and uncontrollable circumstances policy (83 FR 35967). First, beginning with the 2019 MIPS performance period/2021 MIPS payment year, we proposed at § 414.1380(c)(2)(i)(A)(5) (which should have read § 414.1380(c)(2)(i)(A)(6)) that, if a MIPS eligible clinician submits an application for reweighting based on extreme and uncontrollable circumstances, but also submits data on the measures or activities specified for the quality or improvement activities performance categories in accordance with § 414.1325, he or she would be scored on the submitted data like all other MIPS eligible clinicians, and the categories would not be reweighted (83 FR 35967). We proposed this modification to align with a similar policy for the Promoting Interoperability performance category (82 FR 53680 through 53682). We stated that if a MIPS eligible clinician reports on measures or activities specified for the quality or improvement activities performance categories, then we assume the clinician
For most quality measures and improvement activities, the data submission occurs after the end of the MIPS performance period, so clinicians would know about the extreme and uncontrollable circumstance prior to submission. However, for the quality performance category, measures submitted via the Medicare Part B claims collection type are submitted by adding quality data codes to a claim. As a result, it is possible that a MIPS eligible clinician could have submitted some Medicare Part B claims collection type data prior to the submission of a reweighting application for extreme and uncontrollable events. Under our proposal, we would score the quality performance category because we have received data. However, we previously finalized at § 414.1380(c) that if a MIPS eligible clinician is scored on fewer than two performance categories, he or she will receive a final score equal to the performance threshold (81 FR 77320 through 77321 and 82 FR 53778 through 53779). If a clinician experiences an extreme and uncontrollable event that affects all of the performance categories, then under our proposal, the clinician would only be scored on the quality performance category if they submit data for only that category. The clinician would also have to submit data for the improvement activities or the Promoting Interoperability performance categories in order to be scored on two or more performance categories and receive a final score different than the performance threshold.
This proposal did not include administrative claims data that we receive through the claims submission process and use to calculate the cost measures and certain quality measures. As finalized in the CY 2017 Quality Payment Program final rule (81 FR 77094 through 77095), and as we are codifying in this final rule at § 414.1325(a)(2), there are no data submission requirements for the cost performance category and for certain quality measures used to assess performance in the quality performance category. Please see section III.I.3.h.(1)(b) of this final rule for a description of collection types, submission types, and submitter types. We calculate performance on these measures using administrative claims data, and clinicians are not required to submit any additional data for these measures. Therefore, we stated that we did not believe that it would be appropriate to void a reweighting application based on administrative claims data we receive for measures that do not require data submission for purposes of MIPS.
We also proposed to apply the policy we finalized for virtual groups in the CY 2018 Quality Payment Program final rule (82 FR 53782 through 53783) to groups submitting reweighting applications for the quality, cost, or improvement activities performance categories based on extreme and uncontrollable circumstances (83 FR 35967). For groups, we would evaluate whether sufficient measures and activities are applicable and available to MIPS eligible clinicians in the group on a case-by-case basis and determine whether to reweight a performance category based on the information provided for the individual clinicians and practice location(s) affected by extreme and uncontrollable circumstances and the nature of those circumstances. In the CY 2019 PFS proposed rule (83 FR 35967), we stated that although we did not specifically propose to apply this policy to groups in the CY 2018 Quality Payment Program proposed rule, our intention was to apply the same policy for groups and virtual groups, and thus if we adopt this proposal, we would apply the policy to groups beginning with the 2018 performance period/2020 MIPS payment year.
We solicited comments on the above proposals. These comments and our responses are discussed below.
We assume that if a MIPS eligible clinician submits data to us following the submission of an application for reweighting based on extreme and uncontrollable circumstances, the clinician believes there are sufficient measures or activities applicable and available to them and would like their data to contribute to their final score. However, once the data is submitted, it will be scored based on performance in accordance with our policies, and the clinician could receive a negative payment adjustment.
After consideration of public comments, we are finalizing our proposal to codify the final policy we adopted beginning with the 2018 MIPS performance period/2020 MIPS payment year to reweight the quality, cost, and improvement activities performance categories based on a request submitted by a MIPS eligible clinician, group, or virtual group that was subject to extreme and uncontrollable circumstances. We are finalizing our proposal that, beginning with the 2019 performance period/2021 MIPS payment year, if a MIPS eligible clinician submits an application for reweighting based on extreme and uncontrollable circumstances, but also
Beginning with the 2019 MIPS performance period, we proposed that a MIPS eligible clinician who joins an existing practice (existing TIN) during the final 3 months of the calendar year in which the MIPS performance period occurs (the performance period year) that is not participating in MIPS as a group would not have sufficient measures applicable and available (83 FR 35967 through 35968). We also proposed that a MIPS eligible clinician who joins a practice that is newly formed (new TIN) during the final 3 months of the performance period year would not have sufficient measures applicable and available, regardless of whether the clinicians in the practice report for purposes of MIPS as individuals or as a group (83 FR 35967 through 35968). In each of these scenarios, we proposed to reweight all four of the performance categories to zero percent for the MIPS eligible clinician and, because he or she would be scored on fewer than two performance categories, the MIPS eligible clinician would receive a final score equal to the performance threshold and a neutral MIPS payment adjustment under the policy at § 414.1380(c) (83 FR 35967 through 35968). We proposed to codify these policies at § 414.1380(c)(2)(i)(A)(3).
We proposed this policy because we are not currently able to identify these MIPS eligible clinicians (or groups if the group is formed in the final 3 months of the performance period year) at the start of the MIPS submission period. When we designed our systems, we incorporated user feedback that requested eligibility information be connected to the submission process. In order to submit data, an individual TIN/NPI or the group TIN must be in the files generated from the MIPS eligibility determination periods. As discussed in the CY 2019 PFS proposed rule (83 FR 35885 through 35886), we have two 12-month determination periods for eligibility. We proposed and are finalizing in section III.II.3.b. of this final rule that the second 12-month segment of the MIPS eligibility determination period will end on September 30 of the calendar year in which the applicable MIPS performance period occurs; therefore, we will have no eligibility information about clinicians who join a practice after September 30 of the performance period year. MIPS eligible clinicians who join an existing practice (existing TIN) in the final 3 months of the performance period year that is not participating in MIPS as a group will not be identified by our systems, and we will not have the ability to inform them that they are eligible or to receive MIPS data from them. Similarly, practices that form (new TIN) in the final 3 months of the performance period year will not be in the MIPS determination files. Accordingly, we stated that the measures and activities would not be available because any data from these MIPS eligible clinicians would not be accessible to us.
If a MIPS eligible clinician joins a practice (existing TIN) in the final 3 months of the performance period year, and the practice is not newly formed and is reporting as a group for the performance period, the MIPS eligible clinician will be able to report as part of that group. In this case, we are able to accept data for the group because the TIN would be in our MIPS eligibility determination files. Therefore, we stated that we believe the measures and activities would be available in this scenario, and reweighting would not be necessary for the MIPS eligible clinician. We noted that, if a MIPS eligible clinician's TIN/NPI combination was not part of the group practice during the MIPS determination period, the TIN/NPI combination will not be identified in our system at the start of the MIPS data submission period; however, if the MIPS eligible clinician qualifies to receive the group final score under our proposal, we would apply the group final score to the MIPS eligible clinician's TIN/NPI combination as soon as the information becomes available. Please see section III.I.3.j.(1) of this final rule for more information about assigning group scores to MIPS eligible clinicians.
We solicited comments on the above proposals. These comments and our responses are discussed below.
After consideration of public comments, we are finalizing as
In conjunction with the CY 2018 Quality Payment Program final rule, and due to the impact of Hurricanes Harvey, Irma, and Maria, we issued an interim final rule with comment period (IFC) in which we adopted on an interim final basis a policy for automatically reweighting the quality, improvement activities, and advancing care information (now referred to as Promoting Interoperability) performance categories for the transition year of MIPS (the 2017 performance period/2019 MIPS payment year) for MIPS eligible clinicians who are affected by extreme and uncontrollable circumstances affecting entire regions or locales (82 FR 53895 through 53900).
In the CY 2019 PFS proposed rule (83 FR 35968), we stated that we believe that a similar automatic extreme and uncontrollable circumstances policy would be appropriate for any year of the MIPS program to account for natural disasters and other extreme and uncontrollable circumstances that impact an entire region or locale. As we discussed in the interim final rule (82 FR 53897), we believe such a policy would reduce burden on clinicians who have been affected by widespread catastrophes and would align with existing policies for other Medicare programs. We proposed at § 414.1380(c)(2)(i)(A)(7) and (c)(2)(i)(C)(3) to apply the automatic extreme and uncontrollable circumstances policy we adopted for the transition year to subsequent years of the MIPS program, beginning with the 2018 MIPS performance period and the 2020 MIPS payment year, with a few additions to address the cost performance category (83 FR 35968). We note that we inadvertently referred to the wrong paragraph of the regulation text in the proposed rule, and the citation should have read § 414.1380(c)(2)(i)(A)(8) instead of § 414.1380(c)(2)(i)(A)(7). For a description of the policy we adopted for the MIPS transition year, we refer readers to the discussion in the interim final rule (82 FR 53895 through 53900).
In the interim final rule (82 FR 53897), we stated that we were not including the cost performance category in the automatic extreme and uncontrollable circumstances policy for the transition year because the cost performance category is weighted at zero percent in the final score for the 2017 MIPS performance period/2019 MIPS payment year. We finalized a 10 percent weight for the cost performance category for the 2018 MIPS performance period/2020 MIPS payment year (82 FR 53643) and are finalizing a 15 percent weight for the 2019 performance period/2021 MIPS payment year (see section III.I.3.h.(3)(a) of this final rule). In the CY 2019 PFS proposed rule (83 FR 35968), we stated that for the reasons discussed in the CY 2018 Quality Payment Program final rule (82 FR 53781), we believe a MIPS eligible clinician's performance on measures calculated based on administrative claims data, such as the measures specified for the cost performance category, could be adversely affected by a natural disaster or other extreme and uncontrollable circumstance, and that the cost measures may not be applicable to that MIPS eligible clinician. Therefore, we proposed to include the cost performance category in the automatic extreme and uncontrollable circumstances policy beginning with the 2018 MIPS performance period/2020 MIPS payment year (83 FR 35968). Under our policy for the transition year, if a MIPS eligible clinician in an affected area submits data for any of the MIPS performance categories by the applicable submission deadline for the 2017 MIPS performance period, he or she will be scored on each performance category for which he or she submits data, and the performance category will not be reweighted to zero percent in the final score (82 FR 53898). Our policy for the transition year did not include measures that are calculated based on administrative claims data (82 FR 53898). As finalized in the CY 2017 Quality Payment Program final rule (81 FR 77094 through 77095), and as we are codifying in this final rule at § 414.1325(a)(2), there are no data submission requirements for the cost performance category, and we will calculate performance on the measures specified for the cost performance category using administrative claims data. We proposed for the cost performance category, if a MIPS eligible clinician is located in an affected area, we would assume the clinician does not have sufficient cost measures applicable to him or her and assign a weight of zero percent to that category in the final score, even if we receive administrative claims data that would enable us to calculate the cost measures for that clinician (83 FR 35968).
In the interim final rule (82 FR 53897), we did not include an automatic extreme and uncontrollable circumstances policy for groups or virtual groups, and we stated in the CY 2019 PFS proposed rule (83 FR 35968) that we continue to believe such a policy is not necessary. Unless we receive data from a TIN indicating that the TIN would like to be scored as a group for MIPS, performance by default is assessed at the individual MIPS eligible clinician level. Similarly, performance is not assessed at the virtual group level unless the member TINs submit an application in accordance with § 414.1315. We stated that if we receive data from a group or virtual group, we would score that data, even if individual MIPS eligible clinicians within the group or virtual group are impacted by an event that would be included in our automatic extreme and uncontrollable circumstances policy. Regardless of whether we receive data from a group or virtual group, we would have no mechanism to determine whether the group or virtual group did not submit data, or submitted data and performed poorly, because it had been affected by an extreme and uncontrollable event unless the group notifies us of its circumstances. Instead of establishing a threshold for groups or virtual groups to receive automatic reweighting based on the number of clinicians in the group or virtual group impacted by extreme and uncontrollable events, we stated that we believe it is preferable that these groups and virtual groups submit an application for reweighting based on extreme and uncontrollable circumstances under our existing policy (82 FR 53780 through 53783) where they may be eligible for reweighting if they establish that the group or virtual group was sufficiently impacted by the extreme and uncontrollable event.
We solicited comments on the above proposals. These comments and our responses are discussed below.
After consideration of public comments received, we are finalizing these proposals and the regulation text at § 414.1380(c)(2)(i)(A)(8) and (c)(2)(i)(C)(3) as proposed.
As discussed in the preceding section III.I.3.i.(2)(b)(ii)(D), in conjunction with the CY 2018 Quality Payment Program final rule, and due to the impact of Hurricanes Harvey, Irma, and Maria, we issued an interim final rule with comment period (IFC) in which we adopted on an interim final basis a policy for automatically reweighting the quality, improvement activities, and advancing care information (now referred to as Promoting Interoperability) performance categories for the transition year of MIPS (the 2017 performance period/2019 MIPS payment year) for MIPS eligible clinicians who are affected by extreme and uncontrollable circumstances affecting entire regions or locales (82 FR 53895 through 53900). In the CY 2019 PFS proposed rule (83 FR 35968), we proposed to codify this policy for the quality and improvement activities performance categories at § 414.1380(c)(2)(i)(A)(6) and for the advancing care information (now Promoting Interoperability) performance category at § 414.1380(c)(2)(i)(C)(3). We note that we inadvertently referred to the wrong paragraph of the regulation text in the proposed rule, and the citation should have read § 414.1380(c)(2)(i)(A)(7) instead of § 414.1380(c)(2)(i)(A)(6).
A summary of the comments we received on the IFC and our responses are included below.
After consideration of the public comments, we are adopting the IFC as a final rule without any modifications. We are finalizing the regulation text at § 414.1380(c)(2)(i)(A)(7) and § 414.1380(c)(2)(i)(C)(3) as proposed.
In the CY 2017 and CY 2018 Quality Payment Program final rules, we established policies for redistributing the weights of performance categories for the 2019 and 2020 MIPS payment years in the event that a scoring weight different from the generally applicable weight is assigned to a category or categories (81 FR 77325 through 77329; 82 FR 53783 through 53785, 53895 through 53900). We proposed to codify these policies under § 414.1380(c)(2)(ii) (83 FR 35969).
For the 2021 MIPS payment year, we proposed at § 414.1380(c)(2)(ii)(B) to apply similar reweighting policies as finalized for the 2020 MIPS payment year (83 FR 35969). We note that we inadvertently referred to the wrong paragraph of the regulation text in the proposed rule, and the citation should have read § 414.1380(c)(2)(ii)(C) instead of § 414.1380(c)(2)(ii)(B). In general, we would redistribute the weight of a performance category or categories to the quality performance category. We stated that redistributing weight to the quality performance category is appropriate because of the experience MIPS eligible clinicians have had reporting on quality measures under other CMS programs. We proposed to continue to redistribute the weight of the quality performance category to the improvement activities and Promoting Interoperability performance categories (83 FR 35969). However, for the 2021 MIPS payment year, based on our proposal to weight the cost performance category at 15 percent, we proposed to reweight the Promoting Interoperability performance category to 45 percent and the improvement activities performance category to 40 percent when the quality performance category is weighted at zero percent (83 FR 35969). We chose to weigh Promoting Interoperability higher in order to align with goals of interoperability and for simplicity because we generally have avoided assigning partial percentage points to performance category weights. Reweighting scenarios under the proposal are presented in Table 54.
We stated that we have heard from stakeholders in previous years that our reweighting policies place undue weight on the quality performance category, and, although we continue to believe the policies are appropriate, we solicited comment on alternative redistribution policies in which we would also redistribute weight to the improvement activities performance category (see Table 55). Under the alternative redistribution policy we considered, we would redistribute the weight of the Promoting Interoperability performance category to the quality and improvement activities performance categories (83 FR 35969 through 35970). We would redistribute 15 percent of the Promoting Interoperability performance category weight to the quality performance category, and 10 percent to the improvement activities performance category. We stated that redistributing more of the weight of the Promoting Interoperability performance category to the quality performance category is appropriate because MIPS eligible clinicians have had more experience reporting on quality measures under other CMS programs than reporting on improvement activities. We would redistribute the cost performance category weight equally to the quality and improvement activities performance categories (5 percent to each) under this alternative policy.
We solicited comments on the above proposals. These comments and our responses are discussed below.
After consideration of public comments, we are finalizing these proposals and the regulation text at § 414.1380(c)(2)(ii)(A) through (C) as proposed.
Because the cost performance category was zero percent of a MIPS eligible clinician's final score for the 2017 MIPS performance period, we stated in the CY 2019 PFS proposed rule (83 FR 35970) that it is not appropriate to redistribute weight to the cost performance category for the 2019 MIPS performance period because MIPS eligible clinicians have limited experience being scored on cost measures for purposes of MIPS. In addition, we were concerned that there would be limited measures in the cost performance category under our proposals for the 2019 MIPS performance period and stated that it may be appropriate to delay shifting additional weight to the cost performance category until additional measures are developed. However, we also noted that cost is a critical component of the Quality Payment Program and believe placing additional emphasis on the cost performance category in future years may be appropriate. Therefore, we solicited comment on redistributing weight to the cost performance category in future years.
We thank commenters for their input and will take this input into consideration in future years.
We proposed to revise the formula at § 414.1380(c) for calculating the final score (83 FR 35970). We did not propose to continue to add the small practice bonus to the final score for the 2021 MIPS payment year and proposed to add a small practice bonus to the quality performance category score instead starting with the 2021 MIPS payment year (83 FR 35950 through 35951). Therefore, we proposed to revise the formula to omit the small practice bonus from the final score calculation beginning with the 2021 MIPS payment year (83 FR 35970). We requested public comments on this proposal.
Although we received several comments on the small practice bonus, we did not receive any comments on our proposed revisions to the formula to calculate the final score. We discuss our policy for our revised small practice bonus in the quality performance category in section III.I.3.i.(1)(b)(viii) of this final rule.
After consideration of public comments, we are finalizing our proposed revisions to § 414.1380(c) as proposed.
In the CY 2019 PFS proposed rule, we solicited comments on approaches to simplify calculation of the final score (83 FR 35970). We thank commenters for their input and will take this input into consideration in future years.
For our previously established policies regarding the final score used in payment adjustment calculations, we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77330 through 77332) and the CY 2018 Quality Payment Program final rule (82 FR 53785 through 53787). Under our policies, 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 (82 FR 53785). We proposed to modify this policy for the application of the group final score, beginning with the 2019
We noted that, if a MIPS eligible clinician's TIN/NPI combination was not part of the group practice during the MIPS determination period, the TIN/NPI combination would not be identified in our system at the start of the MIPS data submission period; however, if the MIPS eligible clinician qualifies to receive the group final score under our proposal, we would apply the group final score to the MIPS eligible clinician's TIN/NPI combination as soon as the information becomes available.
We solicited comments on the above proposal.
After consideration of the comments we received, we are finalizing our proposed 15-month window that starts with the second segment of the MIPS determination period (October 1 prior to the calendar year of the performance period through September 30 of the calendar year of the performance period) and also includes the final 3 months of the calendar year of the performance period (October 1 through December 31 of the calendar year of the performance period). We are also finalizing that for groups submitting data using the TIN identifier, we will apply the group final score to all of the TIN/NPI combinations that bill under that TIN during the 15-month window. We refer readers to section III.I.3.i.(2)(b)(ii)(C) of this final rule for a detailed discussion of the reweighting of the quality, cost, improvement activities and Promoting Interoperability performance categories for MIPS eligible clinicians who join a group practice in the final 3 months of the calendar year of the performance period.
Under section 1848(q)(6)(D)(i) of the Act, for each year of 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 included 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
In addition, section 51003(a)(1)(D) of the Bipartisan Budget Act of 2018 added a new clause (iv) to section 1848(q)(6)(D) of the Act, which includes an additional special rule for the third, fourth, and fifth years of MIPS (the 2021 through 2023 MIPS payment years). This additional special rule provides, for purposes of determining the MIPS payment adjustment factors under section 1848(q)(6)(A) of the Act, in addition to the requirements specified in section 1848(q)(6)(D)(iii) of the Act, the Secretary shall increase the performance threshold for each of the third, fourth, and fifth years to ensure a gradual and incremental transition to the performance threshold described in section 1848(q)(6)(D)(i) of the Act (as estimated by the Secretary) with respect to the sixth year (the 2024 MIPS payment year) to which the MIPS applies.
To determine a performance threshold to propose for the third year of MIPS (2019 MIPS performance period/2021 MIPS payment year), in the CY 2019 PFS proposed rule (83 FR 35971), we again relied upon the special rule in section 1848(q)(6)(D)(iii) of the Act, as amended by 51003(a)(1)(D) of the Bipartisan Budget Act of 2018. As required by section 1848(q)(6)(D)(iii) of the Act, we considered data available from a prior period with respect to performance on measures and activities that may be used under the MIPS performance categories. In accordance with newly added clause (iv) of section 1848(q)(6)(D) of the Act, we also considered which data could be used to estimate the performance threshold for the 2024 MIPS payment year to ensure a gradual and incremental transition from the performance threshold we would establish for the 2021 MIPS payment year. In the CY 2019 PFS proposed rule (83 FR 35971), we noted that we considered using the final scores for the 2017 MIPS performance period/2019 MIPS payment year; however, the data used to calculate the final scores was submitted through the first quarter of 2018, and final scores for MIPS eligible clinicians were not available in time for us to use in our analyses. We noted that if technically feasible, we would consider using the actual data used to determine the final scores for the 2019 MIPS payment year to estimate a performance threshold for the 2024 MIPS payment year in the final rule.
Because the final scores for MIPS eligible clinicians were not yet available at the time of the CY 2019 PFS proposed rule, we reviewed the data relied upon for the CY 2017 Quality Payment Program final rule regulatory impact analysis (81 FR 77514 through 77536) as we believed it was the best data available to us to estimate the actual data for the 2017 MIPS performance period/2019 MIPS payment year (83 FR 35971). Please refer to the CY 2019 PFS proposed rule (83 FR 35971 through 35973) for more details about the data we used.
In accordance with section 1848(q)(6)(D)(i) of the Act, the performance threshold for the 2024 MIPS payment year would be either the mean or median of the final scores for all MIPS eligible clinicians for a prior period specified by the Secretary. In the CY 2019 PFS proposed rule (83 FR 35972), we stated that when we analyzed the estimated final scores for the first year of the program (the 2019 MIPS payment year), the mean final score was between 63.50 and 68.98 points and the median was between 77.83 and 82.5 points based on the different participation assumptions. For purposes of estimating the performance threshold for the 2024 MIPS payment year, we used the mean final score based on data used for the CY 2017 Quality Payment Program final rule regulatory impact analysis (81 FR 77514 through 77536), which resulted in an estimated performance threshold between 63.50 and 68.98 points for the 2024 MIPS payment year. We noted that this is only an estimation we are providing in accordance with section 1848(q)(6)(D)(iv) of the Act, and we will propose the actual performance threshold for the 2024 MIPS payment year in future rulemaking.
We proposed a performance threshold of 30 points for the 2021 MIPS payment year to be codified at § 414.1405(b)(6) (83 FR 35972). A performance threshold of 30 points would be a modest increase over the performance threshold for the 2020 MIPS payment year (15 points), and we stated that we believe it would provide a gradual and incremental transition to the performance threshold we will establish for the 2024 MIPS payment year, which we have estimated would be between 63.50 and 68.98 points.
We stated that we want 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 2024 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. Additionally, we stated that we believe a modest increase from the performance threshold for the 2020 MIPS payment year would be particularly important to reduce the burden for MIPS eligible clinicians in small or solo practices. We stated that we believe that active participation of MIPS eligible clinicians in MIPS will improve the overall quality, cost, and care coordination of services provided to Medicare beneficiaries.
In the CY 2019 PFS proposed rule (83 FR 35972), we noted that we heard from stakeholders requesting that we continue a low performance threshold and from stakeholders that requested we ramp up the performance threshold to help MIPS eligible clinicians prepare for a future performance threshold of the mean or median of final scores and to meaningfully incentivize higher performance. We also noted that we heard from stakeholders who stated a higher performance threshold may incentivize higher performance by MIPS eligible clinicians through higher positive MIPS payment adjustments for those who exceed the performance threshold. We noted our belief that a performance threshold of 30 points for the 2021 MIPS payment year would provide a gradual and incremental increase from the performance threshold of 15 points for the 2020 MIPS payment year and could incentivize higher performance by MIPS eligible clinicians.
We also noted our belief that a performance threshold of 30 points represents a meaningful increase compared to 15 points, while maintaining flexibility for MIPS eligible clinicians in the pathways available to achieve this performance threshold, and we provided examples to support our belief in the CY 2019 PFS proposed rule (83 FR 35972). We invited public comment on the proposal to set the performance threshold for the 2021 MIPS payment year at 30 points (83 FR 35972). Alternatively, we considered whether the performance threshold should be set at a higher or lower number, for example, 25 points or 35 points, and also sought comment on
We solicited comments on the above proposal.
We also do not believe that increasing the performance threshold to 30 points is unreasonable or too steep, but is rather a moderate step that encourages clinicians to gain experience with all MIPS performance categories. In the CY 2019 PFS proposed rule, we estimated the performance threshold we would establish for the 2024 MIPS payment year would be between 63.50 and 68.98 points. This information was based on year 1 estimates from the regulatory impact analysis (83 FR 35972; 81 FR 77514 through 77536). When we looked at the actual final scores for MIPS eligible clinicians for the 2017 MIPS performance period/2019 MIPS payment year, we found the mean final score was 74.01 points and the median final score was 88.97 points. As discussed in section VII.F.8.d. of the Regulatory Impact Analysis (RIA) of this final rule, we also estimated the potential final scores for the 2019 MIPS performance period/2021 MIPS payment year. In the RIA, we updated our estimates by using data submitted for the first year of MIPS (2017 MIPS performance period/2019 MIPS payment year) and applying the scoring and eligibility policies for the third year of MIPS (the 2019 MIPS performance period/2021 MIPS payment year). In the RIA, we estimated the mean final score for the 2019 performance period/2021 MIPS payment year at 69.53 points and the median final score at 78.72 points. Based on these numbers, we estimate the performance threshold that we would establish for the 2024 MIPS payment year would likely be over 65 points. We believe that if we set the performance threshold at 20 points (or another number lower than 30 points) for the 2021 MIPS payment year, then the increases in the performance threshold for each of the 2022 and 2023 MIPS payment years would have to be steeper to ensure a gradual and incremental transition to the performance threshold for the 2024 MIPS payment year, in accordance with 1848(q)(6)(D)(iv) of the Act.
Additionally, we recognize that some policy changes, such as those finalized in this final rule for the Promoting Interoperability performance category, the impact of topped out measures on the quality performance category, the increased weighting of the cost performance category, and the introduction of episode-based cost measures may dampen final scores because it will be more difficult to achieve a perfect performance category score of 100 percent. However, we believe there are also many options for a MIPS eligible clinician, including a newly eligible clinician, to earn a final score at or above a performance threshold of 30 points that do not require a perfect score in every performance category and that these policies do not preclude a MIPS eligible clinician from performing well. For example, a MIPS eligible clinician that submits the maximum number of improvement activities (achieving 40 points out of a possible 40 points) that is weighted at 15 percent of the final score (100 percent improvement activities performance category score × 15 percent × 100 equals 15 points toward the final score) and achieves a quality performance category score of 35 percent
We agree with commenters about the need to educate clinicians, including newly eligible clinicians, about MIPS program policies and policy changes from year to year and encourage
We also note that eligible clinicians have received performance feedback based on their performance in year 1 of MIPS. As previously finalized in the CY 2018 Quality Payment Program final rule (82 FR 53801 through 53802), on an annual basis, beginning July 1, 2018, performance feedback will be provided 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 (now known as Promoting Interoperability) performance categories. For details on the release of the feedback reports for the first year of MIPS, we refer readers to section III.I.3.g. of this final rule.
After consideration of the comments, we are finalizing our proposal to set the performance threshold at 30 points for the 2021 MIPS payment year as proposed. We are codifying the performance threshold for the 2021 MIPS payment year and finalizing the regulation text at § 414.1405(b)(6) as proposed.
We also solicited comment on our approach to estimating the performance threshold for the 2024 MIPS payment year, which in the CY 2019 PFS proposed rule we based on the estimated mean final score for the 2019 MIPS payment year (83 FR 35972). We were particularly interested in whether we should use the median, instead of the mean, and whether in the future we should estimate the mean or median based on the final scores for another MIPS payment year. We also solicited comment on whether establishing a path forward to a performance threshold for the 2024 MIPS payment year that provides certainty to clinicians and ensures a gradual and incremental increase from the performance threshold for the 2021 MIPS payment year to the estimated performance threshold for the 2024 MIPS payment year would be beneficial, and whether it would be beneficial for MIPS eligible clinicians to know in advance the performance threshold for the 2022 and 2023 MIPS payment years to encourage and facilitate increased clinician engagement and prepare clinicians for meeting the performance threshold for the 2024 MIPS payment year.
We thank commenters for their input on these topics and will take this input into consideration in future years.
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 section 1848(q)(6)(C) of the Act. For each such year, the Secretary shall apply either of the following methods for computing the additional performance threshold: (1) The threshold shall be the score that is equal to the 25th percentile of the range of possible final scores above the performance threshold determined under section 1848(q)(6)(D)(i) of the Act; or (2) the threshold shall be the score that is equal to the 25th percentile of the actual final 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.
Under section 1848(q)(6)(C) of the Act, a MIPS eligible clinician with a
As we discussed in the CY 2019 PFS proposed rule (83 FR 35971), we relied on the special rule under section 1848(q)(6)(D)(iii) of the Act, as amended by section 51003(a)(1)(D) of the Bipartisan Budget Act of 2018, to propose a performance threshold of 30 points for the 2021 MIPS payment year. The special rule under section 1848(q)(6)(D)(iii) of the Act also applies for purposes of establishing an additional performance threshold for a year. For the 2021 MIPS payment year, we proposed to again decouple the additional performance threshold from the performance threshold (83 FR 35973 through 35974).
During the time period in which we were drafting the CY 2019 PFS proposed rule, we did not have actual MIPS final scores for a prior performance period. We noted in the CY 2019 PFS proposed rule (83 FR 35973) that if we did 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 30 points, the range of total possible points above the performance threshold is 30.01 to 100 points and the 25th percentile of that range is 47.5, which is less than one-half of the possible 100 points in the MIPS final score. We stated that we do not believe it would be appropriate to lower the additional performance threshold to 47.5 points because we do not believe a final score of 47.5 points demonstrates exceptional performance by a MIPS eligible clinician, as 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 and proposed at § 414.1405(d)(5) to set the additional performance threshold at 80 points for the 2021 MIPS payment year, which is higher than the 25th percentile of the range of the possible final scores above the performance threshold (83 FR 35973).
As required by section 1848(q)(6)(D)(iii) of the Act, we took into account the data available and the modeling described in the CY 2019 PFS proposed rule to estimate final scores for the 2021 MIPS payment year (83 FR 35973). We stated that we believed 80 points was appropriate to incentivize clinicians who have made greater strides to meaningfully participate in the MIPS program to perform at even higher levels. An additional performance threshold of 80 points would require a MIPS eligible clinician to perform well on at least two performance categories. We stated that, generally, a MIPS eligible clinician could receive a maximum score of 45 points for the quality performance category, which is below the 80-point additional performance threshold. In addition, 80 points is at a high enough level that MIPS eligible clinicians must submit data for the quality performance category to achieve this target. We noted the additional performance threshold at 80 points could increase the incentive for excellent performance while keeping the focus on quality performance.
We also stated an increase would encourage increased engagement and further incentivize clinicians whose performance meets or exceeds the additional performance threshold, recognizing that a fixed amount is available for a year under section 1848(q)(6)(F)(iv) of the Act to fund the additional MIPS payment adjustments and that the more clinicians who receive an additional MIPS payment adjustment, the lower the average clinician's additional MIPS payment adjustment will be.
For future years, we stated that we may consider additional increases to the additional performance threshold.
We solicited comments on these proposals.
A few commenters stated the additional performance threshold should not be increased until information is available and data shared with clinicians from the first 2 years of the program about the number of eligible clinicians who were able to earn the additional payment adjustment, including the number of psychiatrists who exceeded the additional performance threshold during the 2017 MIPS performance period.
We appreciate commenters' concerns about the proposed policy changes for MIPS impacting clinicians' ability to exceed the additional performance threshold. While we recognize that some of the policy changes being
In addition, despite these changes, we believe that 75 points is achievable for many clinicians. Based on our most current data, we estimated for the 2019 performance period/2021 MIPS payment year a mean final score of 69.53 points and a median final score of 78.72 points as discussed elsewhere in this section and in section VII.F.8.d. of the RIA of this final rule. We also believe a modest increase above the additional performance threshold for the 2018 MIPS performance period/2020 MIPS payment year would result in an additional performance threshold that is attainable and that would allow for multiple pathways for clinicians, including clinicians in specialty practices whose choice of applicable and available measures will likely vary according to specialty, to perform exceptionally well and would encourage higher performance by clinicians for year 3 of the MIPS program.
We acknowledge that the number of quality measures available to clinicians can vary by specialty and practice. We believe our quality performance category scoring validation policy accounts for certain instances where clinicians have less than 6 measure available. We believe these adjustments allow us to develop a fair comparison across different MIPS eligible clinicians and would not preclude clinicians from reaching the final additional performance threshold.
We also note that we have shared performance feedback with clinicians and groups based on their performance in year 1 of MIPS and recognize that clinicians may make adjustments to their clinical practice in response to that feedback, and because we are trying to balance that year 3 is a transition year with the goal of encouraging clinicians to improve their performance and to deliver value-based, high quality care, we believe that a moderate increase to 75 points is appropriate.
We also note that there were many commenters recommending that the additional performance threshold remain at 70 points and other commenters recommending 75 points. We have considered the totality of the comments and are swayed by the comments requesting a more modest increase to the additional performance threshold. We have also considered the updated regulatory impact analysis which incorporates Quality Payment Program year 1 data to estimate performance for the 2019 performance period/2021 MIPS payment year in section VII.F.8.d. of this final rule and found a mean score of 69.53 points and a median final score of 78.72 points. Given these findings, we believe that a small decrease from the proposed additional performance threshold of 80 points that would fall between the mean and the median would help the additional performance threshold remain attainable and would allow for a larger number of clinicians to receive the additional payment adjustment.
We also believe an increase in the additional performance threshold would incentivize clinicians to increase their focus on value-based care with an emphasis on the delivery of high quality care for patients, but that an increase of 10 points is too steep, and thus, are finalizing an additional performance threshold of 75 points that is midway between our original proposal of 80 points and the additional performance threshold for the 2018 MIPS performance period/2020 MIPS payment year of 70 points.
We also analyzed the data referenced in section VII.F.8.d. of the RIA of this final rule, and found that more small practices than larger practices may find it harder to meet or exceed the additional performance threshold. We
We also note that the additional performance threshold rewards exceptional performance in the MIPS program and a clinician could successfully participate in MIPS by meeting or exceeding the performance threshold and receive a neutral or positive payment adjustment.
We note that a lower additional performance threshold could reduce the maximum additional payment adjustment that a MIPS eligible clinician could potentially receive if the funds available (up to $500 million for the year) are distributed over more clinicians that score above the lower additional performance threshold. For the reasons discussed above, we believe 75 points is appropriate for year 3 and note that the additional performance threshold will be raised in future years.
After consideration of the comments, we are not finalizing our proposal of 80 points for the additional performance threshold and instead are finalizing 75 points for the additional performance threshold for the 2021 MIPS payment year. We are codifying the additional performance threshold for the 2021 MIPS payment year and finalizing the proposed regulation text at § 414.1405(d)(5) with modification to reflect 75 points instead of 80 points.
In the CY 2018 Quality Payment Program final rule (82 FR 53795), we finalized the application of 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. Sections 51003(a)(1)(A)(i) and 51003(a)(1)(E) of the Bipartisan Budget Act of 2018 amended sections 1848(q)(1)(B) and 1848(q)(6)(E) of the Act, respectively, by replacing the references to “items and services” with “covered professional services” (as defined in section 1848(k)(3)(A) of the Act). Covered professional services as defined in section 1848(k)(3)(A) of the Act are those services for which payment is made under, or is based on, the Medicare PFS and which are furnished by an eligible professional. As a result of these changes, the MIPS payment adjustment factor determined under section 1848(q)(6)(A), and as applicable, the additional MIPS payment adjustment factor determined under section 1848(q)(6)(C) of the Act, will be applied to Part B payments for covered professional services furnished by a MIPS eligible clinician during a year beginning with the 2019 MIPS payment year and not to Part B payments for other items and services.
To conform with these amendments to the statute, we proposed to revise § 414.1405(e) to apply the MIPS payment adjustment factor and, if applicable, the additional MIPS payment adjustment factor, to the
We did not receive any comments on this proposal.
We are finalizing our proposed changes to the regulation text at § 414.1405(e) as proposed. We also refer readers to section III.I.3.a. of this final rule where we discuss the covered professional services to which the MIPS payment adjustment could be applied. We also refer readers to section III.I.3.c.(3) of this final rule where we discuss other conforming edits to the regulation text at §§ 414.1310(a), 414.1310(b), and 414.1310(d) that specify the circumstances when the MIPS payment adjustment would not apply to payments for covered professional services furnished by MIPS eligible clinicians on or after January 1, 2019.
In the CY 2018 Quality Payment Program final rule, we did not address the application of the MIPS payment adjustment for non-assigned claims for non-participating clinicians. In the CY 2018 Quality Payment Program final rule (82 FR 53795), we responded to a comment requesting guidance on how the MIPS payment adjustment and the calculation of the Medicare limiting charge amount would be applied for non-participating clinicians, and we stated our intention to address these issues in future rulemaking. Beginning with the 2019 MIPS payment year, we proposed that the MIPS payment adjustment does not apply for non-assigned claims for non-participating clinicians (83 FR 35974). This approach is consistent with the policy for application of the value modifier that was finalized in the CY 2015 PFS final rule (79 FR 67950 through 67951). Sections 1848(q)(6)(A) and 1848(q)(6)(C) of the Act require that we specify a MIPS payment adjustment factor, and if applicable, an additional MIPS payment adjustment factor for each MIPS eligible clinician, and section 1848(q)(6)(E) of the Act (as amended by section 51003(a)(1)(E) of the Bipartisan Budget Act of 2018) requires that these payment adjustment factor(s) be applied to adjust the amount otherwise paid under Part B for covered professional services furnished by the MIPS eligible clinician during the MIPS payment year. When non-participating clinicians choose not to accept assignment for a claim, Medicare makes payment directly to the beneficiary, and the clinician collects payment from the beneficiary. This is referred to as a non-assigned claim. Application of the MIPS payment adjustment to these non-assigned claims would not affect payment to the MIPS eligible clinician. Rather, it would only affect Medicare payment to the beneficiary. If the MIPS payment adjustment were to be applied to non-assigned services, then the Medicare payment to a beneficiary would be increased when the MIPS payment adjustment is positive and decreased when the MIPS payment adjustment is negative. Although the statute does not directly address this situation, it does suggest that the MIPS payment adjustment is directed toward payment to the MIPS eligible clinician and the covered professional services they furnish. We continue to believe that it is important that beneficiary liability not be affected by the MIPS payment adjustment and that the MIPS payment adjustment should be applied to the amount that Medicare pays to MIPS eligible clinicians.
On that basis, we proposed to apply the MIPS payment adjustment to claims that are billed and paid on an assignment-related basis, and not to any non-assigned claims, beginning with the 2019 MIPS payment year (83 FR 35974). We do not expect this proposal would be likely to affect a clinician's decision to participate in Medicare or to otherwise accept assignment for a particular claim, but we solicited comment on whether stakeholders and others believe clinician behavior would change as a result of this policy.
We solicited comments on the above proposal.
After consideration of the comments, we are finalizing our proposal to apply the MIPS payment adjustment to claims that are billed and paid on an assignment-related basis, and not to any non-assigned claims, beginning with the 2019 MIPS payment year.
CMS tests models under section 1115A of the Act that may include model-specific payments made only to model participants under the terms of the model and not to any other providers of services or suppliers. Some of these model-specific payments may be considered payments for covered professional services furnished by a MIPS eligible clinician, meaning that the MIPS payment adjustment factor, and, as applicable, the additional MIPS payment adjustment factor (collectively referred to as the MIPS payment adjustment factors) applied under § 414.1405(e) of our regulations would normally apply to those payments.
Section 1115A(d)(1) of the Act authorizes the Secretary to waive requirements of Title XVIII of the Act (and certain other requirements) as may be necessary solely for the purposes of testing models under section 1115A. We stated in the proposed rule (83 FR 35974 through 35975) that we believe it is necessary to waive the requirement to apply the MIPS payment adjustment factors to a model-specific payment or payments (to the extent such a payment or payments are subject to the requirement to apply the MIPS payment adjustment factors) for purposes of testing a section 1115A model under which such model-specific payment or payments are made in a specified payment amount (for example, $160 per-beneficiary, per-month); or paid according to a methodology for calculating a model-specific payment
We proposed to amend § 414.1405 to add a new paragraph (f) to specify that the MIPS payment adjustment factors applied under § 414.1405(e) would not apply to certain model-specific payments as described above for the duration of a section 1115A model's testing beginning in the 2019 MIPS payment year (83 FR 35974 through 35975). We proposed to use the authority under section 1115A(d)(1) of the Act to waive the requirement to apply the MIPS payment adjustment factors under section 1848(q)(6)(E) of the Act and § 414.1405(e) specifically for these types of payments because the waiver is necessary solely for purposes of testing models that involve such payments (83 FR 35974 through 35975). To illustrate how the proposed waiver would apply, and to provide notice regarding one model-specific payment to which this proposed waiver would apply, we included an example in the proposed rule involving the Monthly Enhanced Oncology Services (MEOS) payment in the Oncology Care Model (OCM) (83 FR 35975).
We solicited comment on this proposal.
The following is a summary of the public comments received in response to our request for comment and our responses:
After considering public comments, we are finalizing our proposal to use the authority under section 1115A(d)(1) of the Act to waive the requirement to apply the MIPS payment adjustment factors under section 1848(q)(6)(E) of the Act and § 414.1405(e) specifically for payments specified at § 414.1405(f) with the clarifying amendments described herein. As discussed in the CY 2019 PFS proposed rule (83 FR 35975), one model-specific payment to which this finalized waiver will apply is the Monthly Enhanced Oncology Services (MEOS) payment in the Oncology Care Model (OCM). The duration of this waiver will begin with the 2019 MIPS payment year and continue for the duration of OCM.
We proposed to provide the public with notice that this proposed new regulation applies to model-specific payments that the Innovation Center elects to test in the future in two ways: first, we would update the Quality Payment Program website (
We solicited comment on this proposal.
The following is a summary of the public comments received in response to our request for comment and our responses:
After considering public comments, we are finalizing our policy as proposed to provide the public with notice in the following two ways: (1) We will update the Quality Payment Program website (
In conjunction with releasing the CY 2019 PFS proposed rule, CMS announced the Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) Demonstration, established by CMS using our demonstration authority under section 402 of the Social Security Amendments of 1967 (as amended). The MAQI Demonstration is designed to test whether excluding MIPS eligible clinicians who participate to a sufficient degree in certain payment arrangements with Medicare Advantage Organizations (MAOs) from the MIPS reporting requirements and payment adjustments will increase or maintain participation in payment arrangements similar to Advanced APMs with MAOs and change the manner in which clinicians deliver care.
We proposed to use the authority in section 402(b) of the Social Security Amendments of 1967 (as amended) to waive requirements of section 1848(q)(6)(E) of the Act and the regulations implementing it in order to waive the payment consequences (positive, negative or neutral adjustments) of the MIPS and to waive the associated MIPS reporting requirements in 42 CFR part 414 adopted to implement the payment consequences, subject to conditions outlined in the Demonstration. We noted, relating to our proposal to waive payment consequences, that the Demonstration would have the effect of removing MIPS eligible clinicians from the population across which positive and negative payment adjustments are calculated under MIPS, and because of the requirement to ensure budget neutrality with regard to the MIPS payment adjustments under section 1848(q)(6)(F)(ii) of the Act, the Demonstration may affect the payment
We proposed that these waivers would be applicable for a MIPS eligible clinician participating in the Demonstration if they meet combined thresholds for Medicare payments or patients through Qualifying Payment Arrangements with MAOs and Advanced APMs, and that these thresholds would match the thresholds for participation in Advanced APMs under the Medicare Option of the Quality Payment Program. We also proposed to calculate thresholds based on aggregate participation in Advanced APMs and Qualifying Payment Arrangements with MAOs, without applying a specific minimum threshold to participation in either type of payment arrangement. For purposes of the Demonstration, we proposed to make determinations about clinicians' Qualifying Payment Arrangements with MAOs, consistent with the criteria used for Other Payer Advanced APMs under the Quality Payment Program and as set forth in § 414.1420. We proposed to begin the MAQI Demonstration in CY 2018, with the 2018 Performance Period, and operate the project for a total of 5 years.
We also noted in the proposed rule that, for eligible clinicians who are excluded from the MIPS reporting requirements and payment adjustment under the MAQI Demonstration, we would waive the provision in section 1848(q)(1)(A)(iii) of the Act requiring that the Secretary shall permit any eligible clinician to voluntarily report on applicable measures and activities. We clarify that, with this waiver, the Demonstration will prohibit voluntary reporting under the MIPS by eligible clinicians who participate in the Demonstration and are not subject to the MIPS reporting requirements and payment adjustment for a given year. This last waiver is intended to prevent potential gaming in the form of an eligible clinician intentionally submitting data showing poor performance for a year for which they are not subject to the MIPS reporting requirements and payment adjustment pursuant to the terms of the Demonstration in order to show improvement in their performance in future years when that improvement could result in higher MIPS scoring.
Section 402(b) of the Social Security Amendments of 1967 (as amended) authorizes the Secretary to waive requirements of Title XVIII that relate to payment and reimbursement in order to carry out demonstrations under section 402(a). We proposed to use this authority to waive certain requirements of section 1848(q) of the Act and the regulations implementing it, specifically the payment consequences (positive, negative or neutral adjustments) of the MIPS and the associated MIPS reporting requirements in 42 CFR part 414 (adopted to implement the payment consequences), subject to conditions outlined in the Demonstration.
We solicited comment on these proposals.
The following is a summary of the public comments, relating to proposed waivers, received in response to our request for comment and our responses:
We also received comments on other provisions associated with the Demonstration.
We are offering support in the form of fact sheets, webinars, online courses, and direct technical assistance to help clinicians successfully participate in the Quality Payment Program, the MIPS or the Advanced APM track. This range of support to help clinician practices actively participate in the Quality Payment Program that can be found at the following website at
We also discussed that the Demonstration would waive the provision in section 1848(q)(1)(A)(iii) of the Act that the Secretary shall permit any eligible clinician to voluntarily report on applicable measures and activities, so that the Demonstration would prohibit reporting under the MIPS by eligible clinicians who participate in the Demonstration and meet the thresholds to be excluded from the MIPS reporting requirements and payment adjustment for a given year. We did not receive any comments on this proposal. We explained that this waiver is necessary to prevent the potential gaming opportunity wherein participating clinicians could intentionally report artificially poor performance under the MIPS for years in which they receive waivers from MIPS payment consequences, then receive artificially inflated quality improvement points under MIPS in later years when they do not receive waivers from MIPS payment consequences. We note here that by prohibiting reporting under MIPS we are also, in effect, disallowing MIPS performance feedback for those clinicians who participate in the Demonstration and meet the criteria to be excluded from the MIPS reporting requirements and payment adjustments. Eligible clinicians who participate in the Demonstration but are not excluded from the MIPS reporting requirements and payment adjustment (whether through participation in the Demonstration or otherwise) would continue to be MIPS eligible clinicians who are subject to the MIPS reporting requirements and payment adjustment as usual.
After considering public comments, we are finalizing our proposals to implement the MAQI Demonstration in CY 2018 and use the authority in section 402(b) of the Social Security Amendments of 1967 (as amended) to waive certain requirements of section 1848(q)(6)(E) of the Act, specifically the payment consequences (positive, negative or neutral adjustments) of the MIPS and the associated MIPS reporting requirements in 42 CFR part 414 adopted to implement the payment consequences, subject to conditions outlined in the Demonstration. We are also finalizing that we will waive the provision in section 1848(q)(1)(A)(iii) of the Act that the Secretary shall permit any eligible clinician to voluntarily report on applicable measures and activities, so that the Demonstration will prohibit reporting under the MIPS by eligible clinicians who participate in the Demonstration and meet the thresholds that will trigger application of the waivers from the MIPS reporting requirements and payment adjustment for a given year. Related to this waiver of the last sentence of section 1848(q)(1)(A)(iii) of the Act, MAQI Participants who are not subject to the MIPS reporting requirements and payment adjustments will therefore not receive MIPS performance feedback under section 1848(q)(12) of the Act.
In addition, we are also announcing our final policies that, under the waivers identified previously: (1) Eligibility for exclusion from the MIPS reporting requirements and payment adjustment under the MAQI Demonstration will be determined using thresholds of combined participation in Qualifying Payment Arrangements and Advanced APMs that are the same as the QP thresholds under the Medicare Option of the Quality Payment Program codified at § 414.1430(a); and (2) Qualifying Payment Arrangements under the MAQI Demonstration will be identified using criteria consistent with those used to identify Other Payer Advanced APMs codified at § 414.1420. To qualify for exclusion from the MIPS reporting requirements and payment adjustment under the MAQI Demonstration, a MAQI participating clinician must meet combined thresholds for Medicare payments or patients through Qualifying Payment Arrangements with MAOs and Advanced APMs, using Demonstration thresholds that match the thresholds for participation in Advanced APMs under the Medicare Option of the Quality Payment Program, and based on aggregate participation in Advanced APMs and Qualifying Payment Arrangements with MAOs, without applying a specific minimum threshold to participation in either type of payment arrangement.
In the CY 2019 PFS proposed rule (83 FR 35978 through 35981), we provided a figure and several tables as illustrative examples of how various final scores would be converted to a MIPS payment adjustment factor, and potentially an additional MIPS payment adjustment factor, using the statutory formula and based on our proposed policies for the 2021 MIPS payment year. We updated the figure and tables based on the policies we are adopting in this final rule, as follows.
Figure 3 provides an example of how various final scores would be converted to a MIPS payment adjustment factor, and potentially an additional MIPS payment adjustment factor, using the statutory formula and based on the policies adopted in this final rule for the 2021 MIPS payment year. In Figure 3, the performance threshold is 30 points. The applicable percentage is 7 percent for the 2021 MIPS payment year. The MIPS payment adjustment factor is determined on a linear sliding scale from zero to 100, with zero being the lowest possible score which receives the negative applicable percentage (negative 7 percent for the 2021 MIPS payment year) and resulting in the lowest payment adjustment, and 100 being the highest possible score which receives the highest positive applicable percentage and resulting in the highest payment adjustment. 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 7.5 points based on the performance threshold of 30 points for the 2021 MIPS payment year). All MIPS eligible clinicians with a final score in this range would receive the lowest negative applicable percentage (negative 7 percent for the 2021 MIPS payment year). Second, the linear sliding scale line for the positive MIPS payment adjustment factor is adjusted by the scaling factor, which cannot be higher than 3.0.
If the scaling factor is greater than zero and less than or equal to 1.0, then the MIPS payment adjustment factor for a final score of 100 would be less than or equal to 7 percent. If the scaling factor is above 1.0, but less than or equal to 3.0, then the MIPS payment adjustment factor for a final score of 100 would be higher than 7 percent.
Only those MIPS eligible clinicians with a final score equal to 30 points (which is the performance threshold in this example) would receive a neutral MIPS payment adjustment. Because the performance threshold is 30 points, we anticipate that more clinicians will receive a positive adjustment than a negative adjustment and that the scaling factor would be less than 1 and the MIPS payment adjustment factor for each MIPS eligible clinician with a final score of 100 points would be less than 7 percent.
Figure 3 illustrates an example of the slope of the line for the linear adjustments and has been updated from prior rules, but it could change considerably as new information becomes available. In this example, the scaling factor for the MIPS payment adjustment factor is 0.159. In this example, MIPS eligible clinicians with a final score equal to 100 would have a MIPS payment adjustment factor of 1.11 percent (7 percent × 0.159). (Note that this is prior to adding the additional payment adjustment for exceptional performance, which is explained below.)
The additional performance threshold is 75 points. An additional MIPS payment 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 MIPS payment adjustment factors is equal to $500,000,000. In Figure 3, the example scaling factor for the additional MIPS payment adjustment factor is 0.358. Therefore, MIPS eligible clinicians with a final score of 100 would have an additional MIPS payment adjustment factor of 3.58 percent (10 percent × 0.358). The total adjustment for a MIPS eligible clinician with a final score equal to 100 would be 1 + 0.0111 + 0.0358 = 1.0469, for a total positive MIPS payment adjustment of 4.69 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 factor. More MIPS eligible clinicians below the performance threshold means the scaling factors would increase because more MIPS eligible clinicians would receive a negative MIPS payment adjustment factor and relatively fewer MIPS eligible clinicians would receive a positive MIPS payment adjustment factor.
Table 56 illustrates the changes in payment adjustments based on the final policies from the 2019 MIPS payment year and the 2020 MIPS payment year, and on final policies for the 2021 MIPS payment year adopted in this final rule, as well as the statutorily required increase in the applicable percent as required by section 1848(q)(6)(B) of the Act.
We note that in this final rule, with the exception of the increase in our small practice bonus in the quality performance category from 3 measure bonus points to 6 measure bonus points, our scoring algorithms have not changed from the CY 2019 PFS proposed rule and that the only policy change from the CY 2019 PFS proposed rule reflected in Figure 3 and Table 56 is that final scores greater than or equal to 75 points qualify for the additional payment adjustment for exceptional performance discussed at section III.I.3.j.(3) of this final rule. Please refer to the CY 2019 PFS proposed rule (83 FR 35979 through 35981) for examples of scenarios in
We refer readers to § 414.1400, the CY 2017 Quality Payment Program final rule (81 FR 77362 through 77390) and the CY 2018 Quality Payment Program final rule (82 FR 53806 through 53819) for our previously established policies regarding third party intermediaries.
In the CY 2019 PFS proposed rule (83 FR 35981 through 35986), we proposed to: (1) Define third party intermediary and require third party intermediaries to be based in the U.S.; (2) update certification requirements for data submission; (3) update the definition of Qualified Clinical Data Registry (QCDR); revise the self-nomination period for QCDRs; update of information required for QCDRs at the time of self-nomination; update consideration criteria for approval of QCDR measures; define the topped out timeline for QCDR measures; (4) revise the self-nomination period for qualified registries; (5) define health IT vendor; (6) update the definition, criteria, and requirements for CMS-approved survey vendor; auditing criteria; and (7) revise probation and disqualification criteria. We finalize these proposals in the manner discussed herein.
In the CY 2019 PFS proposed rule (83 FR 35981), at § 414.1305, we proposed a new definition to define a third party intermediary as an entity that has been approved under § 414.1400 to submit data on behalf of a MIPS eligible clinician, group, or virtual group for one or more of the quality, improvement activities, and Promoting Interoperability performance categories. A QCDR, qualified registry, health IT vendor, or CMS-approved survey vendor are considered third party intermediaries. We also proposed to change the section heading at § 414.1400 from “Third party data submissions” to “Third party intermediaries” to elucidate the definition and function of a third party intermediary (83 FR 35981).
As discussed in the CY 2019 PFS proposed rule (83 FR 35981), CMS IT systems are required to adhere to multiple agency and federal security standards and policy. CMS policy prohibits non-U.S. citizens from accessing CMS IT systems, and also requires all CMS program data to be retained in accordance with U.S. Federal policy, specifically National Institute of Standards and Technology (NIST) Special Publication (SP) 800-63, which outlines enrollment and identity proofing requirements (levels of assurance) for federal IT system access. Access to the Quality Payment Program would necessitate passing a remote or in-person Federated Identity Proofing process (that is, Equifax or equivalent). A non-U.S. based third party intermediary's potential lack of a SSN, TIN, U.S. based address, and other elements required for identity proofing and identity verification would impact their ability to pass the necessary background checks. An inability to pass identity proofing may limit or fully deny access to the Quality Payment Program if the intent is to interact with the Quality Payment Program outside of the U.S. for the purposes of reporting and storing data.
These requirements are existing federal policies applicable to all HHS/CMS FISMA systems and assets, and the requirements are not specific to the Quality Payment Program. More information on these policies is available at the following websites: HHS Information Security and Privacy Policy (IS2P) (
We would like to note, third party intermediaries that are authorized by us to submit data on behalf of MIPS eligible clinicians, groups, or virtual groups have not otherwise been evaluated for the capabilities, quality, or any other features or its products. The United States Government and CMS do not endorse or recommend any third party intermediary or its products. Prior to selecting or using any third party intermediary or its products, MIPS eligible clinicians, groups or virtual groups should perform their own due diligence on the entity and its products, including contacting the entity directly to learn more about its products.
The following is a summary of the public comments received on the “Third Party Intermediaries Definition” proposals and our responses:
After consideration of the public comments received, we are finalizing our proposal, as proposed, at § 414.1305, to define a third party intermediary as an entity that has been approved under § 414.1400 to submit data on behalf of a MIPS eligible clinician, group, or virtual group for one or more of the quality, improvement activities, and Promoting Interoperability performance categories. A QCDR, qualified registry, health IT vendor, or CMS-approved survey vendor are considered third party intermediaries. We are also finalizing our proposal, as proposed, to change the section heading at § 414.1400 from “Third party data submissions” to “Third party intermediaries” to elucidate the definition and function of a third party intermediary. In addition, we are finalizing our proposal, as proposed, to amend previously finalized policies at § 414.1400(a)(4) to indicate that a third party intermediary's principle place of business and retention of associated CMS data must be within the U.S. Lastly, we are amending § 414.1400(a)(4)(iv) to state that if the clinician chooses to opt-in in accordance with § 414.1310, the third party intermediary must be able to transmit that decision to CMS.
We previously finalized in the CY 2018 Quality Payment Program final rule (82 FR 53807) at § 414.1400(a)(5), 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 that this certification must occur at the time of the submission and accompany the submission. We have discovered it is not operationally feasible to require certification at the time of submission, or to require that the certification accompany the submission, for submission types by third party intermediaries, including data via direct, login and upload, login and attest, CMS Web Interface or Medicare Part B claims. We refer readers to section III.I.3.h.(1)(b) of this final rule for our proposed modifications to the previously established data submission terminology. In order to address these various submission types that are currently available, in the CY 2019 PFS proposed rule (83 FR 35982), we proposed to amend § 414.1400(a)(5) to state that all data submitted to CMS by a third party intermediary must be certified as true, accurate, and complete to the best of its knowledge and that such certification must be made in a form and manner and at such time as specified by CMS.
We did not receive any public comments on our proposed amendments to the certification requirement imposed on third party intermediaries.
We are finalizing our proposal, as proposed, at § 414.1400(a)(5) to state 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 as true, accurate, and complete to the best of its knowledge, and that such certification must be made in a form and manner and at such time as specified by CMS.
We refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53807 through 53815) and § 414.1400 for our previously finalized policies regarding QCDRs. In the CY 2019 PFS proposed rule (83 FR 35982 through 35984) we proposed to update the following: The definition of QCDR, the self-nomination period for QCDRs, information required for QCDRs at the time of self-nomination, and consideration of criteria for approval of QCDR measures.
In the CY 2017 Quality Payment Program final rule (81 FR 77363 through 77364) at § 414.1305, we finalized the definition of a QCDR to be a CMS-approved entity that has self-nominated and successfully completed a qualification process to determine whether the entity may collect medical or clinical data for the purpose of patient and disease tracking to foster improvement in the quality of care provided to patients.
As described in the CY 2019 PFS proposed rule (83 FR 35982), we want to ensure that QCDRs that participate in MIPS have access to clinical expertise in quality measurement and are able to provide and demonstrate an understanding of the clinical medicine, evidence-based gaps in care, and opportunities for improvement in the quality of care delivered to patients and priorities that are important to MIPS eligible clinicians. From our experiences with QCDRs to date, we have discovered that certain entities with predominantly technical backgrounds have limited understanding of medical quality metrics or the process for developing quality measures are seeking approval as a QCDR. A large number of entities that do not have the necessary clinical expertise to foster quality improvement have self-nominated or indicated their interest in becoming QCDRs. In reviewing previous QCDR measure submissions during the self-nomination and QCDR measure review and approval cycles in MIPS, we have observed that some entities were developing QCDR measures without a complete understanding of measure constructs (such as what is required of a composite measure or what it means to risk-adjust), and in some instances, QCDRs were developing QCDR measures in clinical areas in which they did not have expertise. We are concerned that QCDR measures submitted by such entities for approval have not undergone the same consensus development, scientific rigor, and clinical assessment that is required for measure development, compared to those QCDR measures that are developed by specialty societies and other entities with clinical expertise.
We recognize the importance of these organizations' expertise within the Quality Payment Program; however, do not believe that these types of entities with the absence of clinical expertise in quality measurement, meet the intent of QCDRs. We believe that with the increasing interest in QCDRs and QCDR measure development, it is important to ensure that QCDRs that participate in MIPS are first and foremost in the business of improving the quality of care clinicians provide to their patients through quality measurement and/or disease tracking and have the clinical expertise to do so.
In the CY 2019 PFS proposed rule (83 FR 35982 through 35983), we proposed beginning with the 2022 MIPS payment year, to amend § 414.1305 to modify the definition of a QCDR to state that the approved entity must have clinical expertise in medicine and quality measure development. Specifically, a QCDR would be defined as an entity with clinical expertise in medicine and in quality measurement development that collects medical or clinical data on behalf of a MIPS eligible clinician for the purpose of patient and disease tracking to foster improvement in the quality of care provided to patients.
As described in the CY 2019 PFS proposed rule (83 FR 35983), under § 414.1400(b)(2)(ii), an entity that uses an external organization for purposes of data collection, calculation, or transmission may meet the definition of a QCDR as long as the entity has a signed, written agreement that specifically details the relationship and responsibilities of the entity with the external organization effective as of September 1 the year prior to the year for which the entity seeks to become a QCDR. Thus, we expect entities without clinical expertise in medicine and quality measure development that want to become QCDRs would collaborate or align with entities with such expertise in accordance with § 414.1400(b)(2)(ii).
As a part of the self-nomination process, we will look for entities that have quality improvement, measure development, as well as clinical expertise. We will also follow up with the entity via, for example, email or teleconference, should we question whether or not the entity meets our standards. Alternatively, such entities may seek to qualify as another type of third party intermediary, such as a qualified registry. Becoming a qualified registry does not require the level of measure development expertise that is needed to be a QCDR that develops measures.
The following is a summary of the public comments received on the proposal to update the definition of a QCDR and our responses:
After consideration of the public comments received, we are finalizing our proposal to update the definition of a QCDR at § 414.1305 beginning with the 2022 MIPS payment year, as proposed, to state that a QCDR is an entity with clinical expertise in medicine and in quality measurement development that collects medical or clinical data on behalf of a MIPS eligible clinician for the purpose of patient and disease tracking to foster improvement in the quality of care provided to patients.
In the CY 2017 Quality Payment Program final rule (81 FR 77364), we require at § 414.1400(c)(2) that the QCDR must have at least 25 participants by January 1 of the performance period. These participants do not need to use the QCDR to report MIPS data to us; rather, they need to submit data to the QCDR for quality improvement. We realize that a QCDR's lack of preparedness to accept data from MIPS eligible clinicians and groups beginning on January 1 of the performance period may negatively impact a clinician's ability to use a QCDR to report, monitor the quality of care they provide to their patients (and act on these results) and may inadvertently increase clinician burden. For these reasons, we proposed to redesignate § 414.1400(c)(2) as § 414.1400(b)(2)(i) to state that beginning with the 2022 MIPS Payment Year, the QCDR must have at least 25 participants by January 1 of the year prior to the performance period (83 FR 35983). These participants do not need to use the QCDR to report MIPS data to us; rather, they need to submit data to the QCDR for quality improvement.
The following is a summary of the public comments received on the “Establishment of an Entity Seeking To Qualify as a QCDR” proposals and our responses:
After consideration of the public comments received, we are finalizing our proposal, as proposed, to redesignate § 414.1400(c)(2) as § 414.1400(b)(2)(i) to state that beginning with the 2022 MIPS Payment Year, the QCDR must have at least 25 participants by January 1 of the year prior to the applicable performance period.
We refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53808 through 53813) for our previously established policies regarding the simplified self-nomination process for existing QCDRs in MIPS that are in good standing and web-based submission of self-nomination forms. We did not propose any changes to those policies in this final rule; however, in the CY 2019 PFS proposed rule (83 FR 35983), we proposed to update: (1) The self-nomination period; and (2) information required at the time of self-nomination.
Under § 414.1400(b), QCDRs must self-nominate from September 1 of the year prior to the applicable performance period until November 1 of the same year and must, among other things, provide all information requested by us at the time of self-nomination. As indicated in the CY 2017 Quality Payment Program final rule (81 FR 77366), our goal has been to publish the list of approved QCDRs along with their approved QCDR measures prior to the beginning of the applicable performance period.
We have received feedback from entities that have self-nominated to be a QCDR about the need for additional time to respond to requests for information during the review process, particularly with respect to QCDR measures that the entity intends to submit to us for the applicable performance period. In addition, based on our observations of the previous two self-nomination cycles, we anticipate an increase in the number of QCDR measure submissions for our review and consideration. For the transition year of MIPS, we received over 1,000 QCDR measure submissions for review, and for the CY 2018 performance period, we received over 1,400 QCDR measure submissions. In order for us to process, review, and approve the QCDR measure submissions and provide QCDRs with sufficient time to respond to requests for information during the review process, while still meeting our goal to publish the list of approved QCDRs along with their approved QCDR measures prior to the start of the applicable performance period, we believe that an earlier self-nomination period is needed.
Therefore, in the CY 2019 PFS proposed rule (83 FR 35983), we proposed to update the self-nomination period from September 1 of the year prior to the applicable performance period until November 1 to July 1 of the calendar year prior to the applicable performance period until September 1. Therefore, in the CY 2019 PFS proposed rule (83 FR 35983), we also proposed to amend § 414.1400(b)(1) to provide that, beginning with the 2022 MIPS payment year, entities seeking to qualify as QCDRs must self-nominate during a 60-day period beginning on July 1 of the calendar year prior to the applicable performance period and ending on September 1 of the same year; must provide all information required by us at the time of self-nomination; and must provide any additional information requested by us during the review process. For example, for the 2022 MIPS payment year, the applicable performance period would be CY 2020, as discussed in section III.I.3.g. of this final rule. Therefore for the CY 2020 performance period, the self-nomination period would begin on July 1st, 2019 and end on September 1st, 2019, and we will make QCDRs aware of this through our normal communication channels. We believe that updating the self-nomination period would allow for additional review time and measure discussions with QCDRs.
We refer readers to section III.I.3.k.(3)(c)(ii) of this final rule for a summary of the public comments received on these proposals and our responses.
We refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53814), where we finalized that as a part of the self-nomination review and approval process for the CY 2018 performance period 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 have received some questions from stakeholders as to whether the QCDR measure ID must be utilized or whether it is optional. As stated in the CY 2018 Quality Payment Program final rule, QCDRs, including any other QCDRs that have received permission to also report the measure, must use the CMS-assigned QDCR measure ID. It is important that the CMS-assigned QCDR measure ID is posted and used accordingly, because without this ID we are not able to accurately identify and calculate the QCDR measures according to their specifications. Therefore, in the CY 2019 PFS proposed rule (83 FR 35983), we proposed to update § 414.1400(b)(3)(iii) to state that QCDRs must include their CMS-assigned QCDR measure ID number when posting their approved QCDR measure specifications, and also when submitting data on the QCDR measures to us.
The following is a summary of the public comments received on the “Self-Nomination Process” proposals and our responses:
We believe the benefits of moving up the self-nomination period to allow for additional time and discussion of QCDR measures is beneficial for both QCDRs and CMS. We disagree that the self-nomination period needs to be extended to a 90-day period, we believe with the resource materials provided, as well as us offering to meet with QCDRs prior to self-nomination to discuss their QCDR measures and receive preliminary feedback, QCDRs have the ability to better prepare for the self-nomination period.
The CY 2019 performance period self-nomination form reflects the proposed MIPS quality measures, Promoting Interoperability measures, and Improvement Activities as proposed in the CY 2019 PFS proposed rule. We include disclaimer language that indicates that measures and activity availability are subject to change, pending upon what is finalized in the final rule. We continuously take into consideration stakeholder feedback as we look into process improvements and policy development for future program years. We appreciate the commenters' suggestions, and ask that they provide more detail as to the changes to the licensing standards that they recommend we implement for future consideration.
After consideration of the public comments received, we are finalizing our proposal to amend § 414.1400(b)(1) to provide that, beginning with the 2022 MIPS payment year, entities seeking to qualify as QCDRs must self-nominate during a 60-day period beginning on July 1 of the calendar year prior to the applicable performance period and ending on September 1 of the same year; must provide all information required by us at the time of self-nomination; and must provide any additional information requested by us during the review process. In addition, we are finalizing our proposal to update § 414.1400(b)(3)(iii) to state that QCDRs must include their CMS-assigned QCDR measure ID number when posting their approved QCDR measure specifications, and also when submitting data on the QCDR measures to us.
We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77374 through 77375) for where we previously finalized standards and criteria used for selecting and approving QCDR measures. We finalized that QCDR measures must: Provide specifications for each measure, activity, or objective the QCDR intends to submit to CMS; and provide CMS descriptions and narrative specifications for each measure, activity, or objective no later than November 1 of the applicable performance period for which the QCDR wishes to submit quality measures or other performance category (improvement activities and Promoting Interoperability) data starting with the 2018 performance period and in future program years. In the CY 2019 PFS proposed rule (83 FR 35983), we proposed to consolidate our previously finalized standards and criteria used for selecting and approving QCDR measures at § 414.1400(e) and (f) at § 414.1400(b)(3). We also proposed to apply certain criteria used under the Call for Quality Measures Process when considering QCDR measures for possible inclusion in MIPS beginning with the MIPS 2021 payment year (83 FR 35983).
In the CY 2018 Quality Payment Program final rule (82 FR 53814), we noted our interest in elevating the standards for which QCDR measures are selected and approved for use and sought comment on whether the standards and criteria used for selecting and approving QCDR measures should be more closely aligned with those used for the Call for Quality Measures process described in the CY 2017 Quality Payment Program final rule (81 FR 77151). Some commenters expressed concern with this alignment, stating that the Call for Measures process is cumbersome, and would increase burden. Other commenters expressed the belief that the Call for Measures process does not recognize the uniqueness of QCDRs, and is not agile. We would like to clarify that our intention with any future alignment is to work towards consistent standards and evaluation criteria that would be applicable to all MIPS quality measures, including QCDR measures. We understand that some of the criteria under the Call for Measures process may be difficult for QCDRs to meet prior to submitting a particular measure for approval; however, we believe that the criteria under the Call for Measures process helps ensure that any new measures are reliable and valid for use in the program. Having a greater alignment in measure standards helps ensure that MIPS eligible clinicians and groups are able to select from an array of measures that are considered to be higher quality and provide meaningful measurement. As such, we believe that as we gain additional experience with QCDRs in MIPS, it would be appropriate to further align these criteria for QCDR measures with those of MIPS quality measures in future program years.
Therefore, in addition to the QCDR measure criteria previously finalized at § 414.1400(f), we proposed in the CY 2019 PFS proposed rule (83 FR 35984) to apply select criteria used under the Call for Measures Process, as described in the CY 2018 Quality Payment Program final rule (82 FR 53636). Specifically, in addition to the QCDR measure criteria at proposed § 414.1400(b)(3), we proposed in the CY 2019 PFS proposed rule (83 FR 35984) to apply the following criteria beginning with the 2021 MIPS payment year when considering QCDR measures for possible inclusion in MIPS:
• Measures that are beyond the measure concept phase of development.
• Preference given to 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 believe that as we gain additional experience with QCDRs in MIPS, it would be appropriate to further align these criteria for QCDR measures with those of MIPS quality measures in future program years. Specifically, we are considering proposing to require reliability and feasibility testing as an added criteria in order for a QCDR measure to be considered for MIPS in future rulemaking.
In addition, we refer readers to the CMS Quality Measure Development Plan at
The following is a summary of the public comments received on the “QCDR Measure Requirements” proposals and our responses:
After consideration of the public comments received, we are finalizing our proposal to consolidate our previously finalized standards and criteria used for selecting and approving QCDR measures at § 414.1400(e) and (f) at § 414.1400(b)(3) and to apply certain criteria used under the Call for Quality Measures Process when considering QCDR measures for possible inclusion in MIPS beginning with the MIPS 2021 payment year. We are also finalizing our proposal to apply select criteria used under the Call for Measures Process, as described in the CY 2018 Quality Payment Program final rule (82 FR 53636) in addition to the QCDR measure criteria previously finalized at § 414.1400(f). Specifically, in addition to the QCDR measure criteria that we are finalizing at § 414.1400(b)(3), we are also finalizing our proposal to apply the following criteria beginning with the 2021 MIPS payment year when considering QCDR measures for possible inclusion in MIPS:
• Measures that are beyond the measure concept phase of development.
• Preference given to 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.
In the CY 2018 Quality Payment Program final rule (82 FR 53813), we finalized that beginning with the 2018 performance period and for future program years, QCDR vendors may seek permission from another QCDR to use an existing measure that is owned by the other QCDR. We intended for this policy to help reduce the number of QCDR measures that are similar in concept or clinical topic, or duplicative of other QCDR measures that are being approved. Furthermore, having multiple QCDRs report on the same QCDR measure allows for a larger cohort of clinicians to report on the measure, which helps establish more reliable benchmarks and may give some eligible clinicians or group a better chance of obtaining a higher score on a particular measure. However, we have experienced that this policy has created unintended financial burden for QCDRs requesting permission from other QCDRs who own QCDR measures, as some QCDRs charge a fee for the use of their QCDR measures. MIPS quality measures, while stewarded by specific specialty societies or organizations, are generally available for third party intermediaries, MIPS eligible clinicians, and groups to report on for purposes of MIPS without a fee for use. Similarly, we believe, that once a QCDR measure is approved for reporting in MIPS, it should be generally available for other
The following is a summary of the public comments received on the “QCDRs Seeking Permission from another QCDR to Use an Existing, Approved QCDR Measure” proposals and our responses:
We thank the commenter for their suggestion of implementing a pilot program where QCDRs would need to share measure performance information, test and implement measure changes, and work towards patient-centered outcome measures. We agree that the sharing of performance data, testing results, and moving towards outcome based measures are all important, but will need to look into the feasibility and operations of implementing such requirements. With regards to the development of a standard data dictionary, as described in the CY 2018 Quality Payment Program final rule (82 FR 53813), we encourage QCDR measure developer to utilize the current Measure Development Plan available at
Based on the feedback and concerns raised by stakeholders, in the interim, we are not finalizing at § 414.1400(b)(3)(ii)(C) that as a condition of a QCDR measure's approval for purposes of MIPS, the QCDR measure owner would be required to agree to enter into a license agreement with CMS, permitting any approved QCDR to submit data on the QCDR measure (without modification) for purposes of MIPS and each applicable MIPS payment year. Rather we are retaining our existing policy that QCDR vendors may seek permission from another QCDR to use an existing measure that is owned by the other QCDR (82 FR 53813). We remain very concerned about duplicative measures and their impact to our meaningful measures initiative. We are eager to work with the stakeholder community to determine solutions for this issue and will continue to look for policy resolutions to address this issue.
We are finalizing our proposal at § 414.1400(b)(3)(iii) that other QCDRs would be required to use the same CMS-assigned QCDR measure ID.
We refer readers to § 414.1400 and the CY 2018 Quality Payment Program final rule (82 FR 53815 through 53818) for our previously finalized policies regarding qualified registries. In the CY 2019 PFS proposed rule (83 FR 35984), we proposed to update: Information required for qualified registries at the time of self-nomination and the self-nomination period for qualified registries.
In the CY 2017 Quality Payment Program final rule (81 FR 77383), we state at § 414.1400(h)(2) that the qualified registry must have at least 25 participants by January 1 of the performance period. These participants do not need to use the qualified registry to report MIPS data to us; rather, they need to submit data to the qualified registry for quality improvement. We realize that a qualified registry's lack of preparedness to accept data from MIPS eligible clinicians and groups beginning on January 1 of the performance period may negatively impact a clinician's ability to use a Qualified Registry to report, monitor the quality of care they provide to their patients (and act on these results) and may inadvertently increase clinician burden. For these reasons, in the CY 2019 PFS proposed rule (83 FR 35984), we proposed to redesignate § 414.1400(h)(2) as § 414.1400(c)(2) to state that beginning with the 2022 MIPS Payment Year, the qualified registry must have at least 25 participants by January 1 of the year prior to the applicable performance period. These participants do not need to use the qualified registry to report MIPS data to us; rather, they need to submit data to the qualified registry for quality improvement.
We did not receive any comments on the “Establishment of an Entity Seeking To Qualify as a Qualified Registry.” We are finalizing our proposal to redesignate § 414.1400(h)(2) as § 414.1400(c)(2) to state that beginning with the 2022 MIPS Payment Year, the qualified registry must have at least 25 participants by January 1 of the year prior to the applicable performance period.
We refer readers to § 414.1400(g), the CY 2017 and CY 2018 Quality Payment Program final rules (81 FR 77383 and 82 FR 53815, respectively) for our previously established policies regarding the self-nomination process for qualified registries. We did not propose any changes to this policy.
Under the previously finalized policy at § 414.1400(g), qualified registries must self-nominate from September 1 of the year prior to the applicable performance period until November 1 of the same year and must, among other things, provide all information requested by us at the time of self-nomination. To maintain alignment with the timelines proposed for QCDR self-nomination, as discussed in section III.I.3.k.(3)(c) of this final rule, we also proposed in the CY 2019 PFS proposed rule (83 FR 35985) to update the self-nomination period from September 1 of the year prior to the applicable performance period until November 1 to July 1 of the calendar year prior to the applicable performance period until September 1. Specifically, we proposed in the CY 2019 PFS proposed rule (83 FR 35985) at § 414.1400(c)(1) that, beginning with the 2022 MIPS payment year, entities seeking to qualify as qualified registries must self-nominate during a 60-day period beginning on July 1 of the calendar year prior to the applicable performance period and ending on September 1 of the same year; must provide all information required by us at the time of self-nomination; and must provide any additional information requested by us during the review process. For example, for the 2022 MIPS payment year, the applicable performance period would be CY 2020, as discussed in section III.I.3.g. of this final rule. Therefore, the self-nomination period for qualified registries would begin on July 1, 2019 and end on September 1, 2019.
We did not receive any comments on the “Self-nomination Period” for Qualified Registries. We are finalizing our proposal to amend § 414.1400(c)(1) to provide that, beginning with the 2022 MIPS payment year, entities seeking to qualify as qualified registries must self-nominate during a 60-day period beginning on July 1 of the calendar year prior to the applicable performance period and ending on September 1 of the same year; must provide all information required by us at the time of self-nomination; and must provide any additional information requested by us during the review process.
We refer readers to § 414.1400 and the CY 2017 Quality Payment Program final rule (81 FR 77377 through 77382) for our previously finalized policies regarding health IT vendors or other authorized third parties that obtain data from MIPS eligible clinicians. We finalized that health IT vendors that obtain data from a MIPS eligible clinician, like other third party intermediaries, would have to meet all criteria designated by us as a condition
As indicated in footnote 1 of the CY 2017 Quality Payment Program final rule (81 FR 77014 through 77015), the term “health IT vendor” encompasses many types of entities that support the health IT requirements on behalf of a MIPS eligible clinician. A “health IT vendor” may or may not also be a “health IT developer” for the purposes of the ONC Health IT Certification Program (Program), and, in some cases, the developer and the vendor of a single product may be different entities. Under the Program, a health IT developer constitutes a vendor, self-developer, or other entity that presents health IT for certification or has health IT certified under the Program. Other health IT vendors may maintain a range of data transmission, aggregation, and calculation services or functions, such as organizations which facilitate health information exchange.
We did not receive any comments on the “Health IT Vendors or Other Authorized Third Parties That Obtain Data From MIPS Eligible Clinicians' Certified EHR Technology (CEHRT).” Therefore, we are finalizing our proposal to codify our previously established policies at § 414.1400(d). We are also finalizing our proposal to define at § 414.1305, that health IT vendor means an entity that supports the health IT requirements on behalf of a MIPS eligible clinician (including obtaining data from a MIPS eligible clinician's CEHRT).
In the CY 2017 Quality Payment Program final rule (81 FR 77386), we finalized the criteria, required forms, and vendor business requirements needed to participate in MIPS as a CMS-approved survey vendor. In the CY 2019 PFS proposed rule (83 FR 35985), we proposed at § 414.1400(e) to codify these previously finalized criteria and requirements. Accordingly, we proposed in the CY 2019 PFS proposed rule (83 FR 35985) at § 414.1400(e) that an entity seeking to be a CMS-approved survey vendor for any MIPS performance period must submit a survey vendor application to CMS in a form and manner specified by CMS for each MIPS performance period for which it wishes to transmit such data. We also proposed to require that the application and any supplemental information requested by CMS must be submitted by deadlines specified by CMS. In addition, we proposed that a CMS-approved survey vendor must meet several criteria. First, we proposed to require that an entity have sufficient experience, capability, and capacity to accurately report CAHPS data, including:
• At least 3 years of experience administering mixed-mode surveys (surveys that employ multiple modes to collect data) that include mail survey administration followed by survey administration via Computer Assisted Telephone Interview (CATI);
• At least 3 years of experience administering surveys to a Medicare population;
• At least 3 years of experience administering CAHPS surveys within the past 5 years;
• Experience administering surveys in English and one of the following languages: Cantonese; Korean; Mandarin; Russian; or Vietnamese;
• Use of equipment, software, computer programs, systems, and facilities that can verify addresses and phone numbers of sampled beneficiaries, monitor interviewers, collect data via CATI, electronically administer the survey and schedule call-backs to beneficiaries at varying times of the day and week, track fielded surveys, assign final disposition codes to reflect the outcome of data collection of each sampled case, and track cases from mail surveys through telephone follow-up activities; and
• Employment of a program manager, information systems specialist, call center supervisor and mail center supervisor to administer the survey.
Furthermore, we proposed in the CY 2019 PFS proposed rule (83 FR 35985) that to be a CMS-approved survey vendor, the entity must also meet the following criteria:
• It must have certified that it has the ability to maintain and transmit quality data in a manner that preserves the security and integrity of the data;
• The entity must have successfully completed, and required its subcontractors to successfully complete, vendor training(s) administered by CMS or its contractors;
• The entity must have submitted a quality assurance plan and other materials relevant to survey administration, as determined by CMS, including cover letters, questionnaires and telephone scripts;
• The entity must have agreed to participate and cooperate, and have required its subcontractors to participate and cooperate, in all oversight activities related to survey administration conducted by CMS or its contractors; and
• The entity must have sent an interim survey data file to CMS that establishes the entity's ability to accurately report CAHPS data.
We also refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53818 through 53819) for our previously established policies regarding the updated survey vendor application deadline.
The following is a summary of the public comments received on the “CMS-Approved Survey Vendors” proposals and our responses:
After consideration of the public comments received, we are finalizing our proposal at § 414.1400(e) to state that entities seeking to be a CMS-approved survey vendor for any MIPS
An entity must have sufficient experience, capability, and capacity to accurately report CAHPS data, including:
• At least 3 years of experience administering mixed-mode surveys (surveys that employ multiple modes to collect data) that include mail survey administration followed by survey administration via Computer Assisted Telephone Interview (CATI);
• At least 3 years of experience administering surveys to a Medicare population;
• At least 3 years of experience administering CAHPS surveys within the past 5 years;
• Experience administering CAHPS surveys in English and at least one other language for which a translation of the CAHPS for MIPS survey is available. These languages currently consist of Cantonese, Korean, Mandarin, Russian, Spanish or Vietnamese;
• Use of equipment, software, computer programs, systems, and facilities that can verify addresses and phone numbers of sampled beneficiaries, monitor interviewers, collect data via CATI, electronically administer the survey and schedule call-backs to beneficiaries at varying times of the day and week, track fielded surveys, assign final disposition codes to reflect the outcome of data collection of each sampled case, and track cases from mail surveys through telephone follow-up activities; and
• Employment of a program manager, information systems specialist, call center supervisor and mail center supervisor to administer the survey.
In addition, we are finalizing without change our proposal that an entity must have certified that it has the ability to maintain and transmit quality data in a manner that preserves the security and integrity of the data; the entity must have successfully completed, and has required its subcontractors to successfully complete, vendor training(s) administered by CMS or its contractors; the entity must have submitted a quality assurance plan and other materials relevant to survey administration, as determined by CMS, including cover letters, questionnaires and telephone scripts; the entity must have agreed to participate and cooperate, and have required its subcontractors to participate and cooperate, in all oversight activities related to survey administration conducted by CMS or its contractors; and the entity must have sent an interim survey data file to CMS that establishes the entity's ability to accurately report CAHPS data.
In the CY 2018 Quality Payment Program final rule (82 FR 53819), we established at § 414.1400(j) policies regarding auditing of third party intermediaries submitting MIPS data. In the CY 2019 PFS proposed rule (83 FR 35985), we did not propose any changes to these policies. In this final rule, the provision that currently appears at § 414.1400(j) is redesignated as § 414.1400(g) and contains no substantive changes.
In the CY 2017 Quality Payment Program final rule (81 FR 77548), we finalized the criteria for probation and disqualification for third party intermediaries at § 414.1400(k). In the CY 2019 PFS proposed rule (83 FR 35986), we proposed to revise the numbering of this section and the title to more accurately describe the policies in this section. Specifically, we proposed to renumber this section as § 414.1400(f) and to rename it as “remedial action and termination of third party intermediaries.” Additionally, we proposed in the CY 2019 PFS proposed rule (83 FR 35986) changes to § 414.1400(f) to amend, clarify, and streamline our policies related to remedial action and termination.
Our intent with these policies is to identify and remedy noncompliance with the applicable third party intermediary criteria, as well as identify issues that may impact the accuracy of or our ability to use the data submitted by third party intermediaries. Accordingly, in the CY 2019 PFS proposed rule (83 FR 35986), we proposed to amend § 414.1400(f)(1) to state that we may take remedial action for noncompliance with applicable third party intermediary criteria for approval (a deficiency) or for the submission of inaccurate, unusable, or otherwise compromised data. In the CY 2017 Quality Payment Program final rule, we finalized our policy regarding data inaccuracies at § 414.1400(k)(4). In the CY 2019 PFS proposed rule (83 FR 35986), we proposed at § 414.1400(f)(3) to expand data inaccuracies to include a determination by us that data is inaccurate, unusable, or otherwise compromised. However, we did not propose to change the factors we may consider to make such a determination. In the CY 2019 PFS proposed rule (83 FR 35986), we also proposed to move the notification requirement at § 414.1400(k)(6) to § 414.1400(f)(1) and to apply the requirement to all deficiencies and data errors.
Based on our early experience with third party intermediaries under MIPS and the challenges for both third party intermediaries and us in regards to timing and trying to resolve deficiencies and data errors within the various reporting and performance periods, we proposed in the CY 2019 PFS proposed rule (83 FR 35986) to amend the timeframes by which a third party intermediary must submit a Corrective Action Plan (CAP) to us or come into compliance. Specifically, we proposed § 414.1400(f)(2), which requires third party intermediaries to submit a CAP or correct the deficiencies or data errors by the date specified by us (83 FR 35986).
Additionally, we proposed in the CY 2019 PFS proposed rule (83 FR 35986) to consolidate at § 414.1400(f)(1) the grounds for remedial action against a third party intermediary currently specified at § 414.1400(k)(1) and (4) and to consolidate at § 414.1400(f)(2) the grounds for terminating a third party intermediary currently found at § 414.1400(k)(3), (5) and (7). Therefore, we proposed at § 414.1400(f)(1) that if at any time we determine that a third party intermediary has ceased to meet one or more of the applicable criteria for approval, or has submitted data that is inaccurate, unusable, or otherwise compromised, we may take certain remedial actions (for example, request a CAP) (83 FR 35986). In the CY 2019 PFS proposed rule (83 FR 35986), we also proposed at § 414.1400(f)(2) that we may terminate, immediately or with advance notice, the ability of a third party intermediary to submit MIPS data on behalf of a MIPS eligible clinician, group, or virtual group for one or more of the following reasons: We have grounds to impose remedial action, we have not received a CAP within the specified time period or the CAP is not accepted by us, or the third party intermediary fails to correct the deficiencies or data errors by the date specified by us.
Additionally, in the CY 2019 PFS proposed rule (83 FR 35986), we proposed to consolidate at § 414.1400(f)(1) the actions we may take
In the CY 2019 PFS proposed rule (83 FR 35986), we also proposed that CMS may determine that submitted data is inaccurate, unusable, or otherwise compromised if the submitted data: (1) Includes, without limitation, TIN/NPI mismatches, formatting issues, calculation errors, or data audit discrepancies; and (2) affects more than 3 percent (but less than 5 percent) of the total number of MIPS eligible clinicians or group for which data was submitted by the third party intermediary. In addition, we proposed in the CY 2019 PFS proposed rule (83 FR 35986) that if the third party intermediary has a data error rate of 3 percent or more, we will publicly disclose the entity's data error rate on the CMS website until the data error rate falls below 3 percent.
We clarify in this final rule that CMS may determine that submitted data is inaccurate, unusable, or otherwise compromised if the submitted data affects more than 3 percent of the total number of MIPS eligible clinicians or group for which data was submitted by the third party intermediary. In the CY 2017 Quality Payment Program final rule (81 FR 77387 through 77388), we explained that if a third party intermediary has data inaccuracies including (but not limited to) TIN/NPI mismatches, formatting issues, calculation errors, data audit discrepancies affecting in excess of 3 percent (but less than 5 percent) of the total number of MIPS eligible clinicians or groups submitted by the third party intermediary, we would annotate on the CMS qualified posting that the third party intermediary furnished data of poor quality and would place the entity on probation for the subsequent MIPS performance period. If a third party intermediary does not reduce their data error rate below 3 percent for the subsequent performance period, the third party intermediary would continue to be on probation and have their listing on the CMS website continue to note the poor quality of the data they are submitting for MIPS for one additional performance year. After 2 years on probation, the third party intermediary would be disqualified for the subsequent performance year. We also explained that data errors affecting in excess of 5 percent of MIPS eligible clinicians or group submitted by the third party intermediary may lead to the disqualification of the third party intermediary from participation for the following performance period (that is, without first placing the third party intermediary on probation).
Accordingly, it was always our intent that data errors affecting in excess of 3 percent of the MIPS eligible clinicians or group submitted by a third party intermediary would result in remedial action or disqualification (termination) of the third party intermediary. In this final rule, we are correcting an obvious error in the regulation text we proposed at § 414.1400(f)(3)(ii) to clarify that if submitted data is inaccurate, unusable, or otherwise compromised if errors in the submitted data affect more than 3 percent of the total number of MIPS eligible clinicians or group for which data was submitted by the third party intermediary.
Finally, we proposed to remove our probation policy. Therefore, we proposed in the CY 2019 PFS proposed rule (83 FR 35986) to remove the definition of probation at § 414.1400(k)(2) and references to probation in § 414.1400(k)(1), (3) and (5).
The following is a summary of the public comments received on the “Remedial Action and Termination of Third Party Intermediaries” proposals and our responses:
After consideration of the public comments received, we are finalizing our proposal to revise the numbering of § 414.1400(k) as § 414.1400(f) and to rename it as “remedial action and termination of third party intermediaries.” We are also finalizing our proposal to amend, clarify, and streamline our policies related to remedial action and termination as follows:
• We are finalizing § 414.1400(f)(1) to state that CMS may take one or more of the following remedial actions if we determine that a third party intermediary has ceased to meet one or more of the applicable third party intermediary criteria for approval or has submitted data that is inaccurate, unusable, or otherwise compromised: We will require the third party intermediary to submit by a deadline specified by CMS a CAP that addressed the identified deficiencies or data issue, including the actions it will take to prevent the deficiencies or data issues from recurring; or we will publicly disclose the entity's data error rate on the CMS website until the data error rate falls below 3 percent.
• We are finalizing § 414.1400(f)(2) to state that CMS may immediately or with advance notice terminate the ability of a third party intermediary to submit MIPS data on behalf of a MIPS eligible clinician group, or virtual group for one or more of the following reasons: CMS has grounds to impose remedial action; CMS has not received a CAP within the specified time period or the CAP is not accepted by CMS; or, the third party intermediary fails to correct the deficiencies or data errors by the date specified by CMS.
• We are finalizing § 414.1400(f)(3) to state that, for purposes of paragraph (f), CMS may determine that submitted data is inaccurate, unusable, or otherwise compromised if it: Includes, without limitation, TIN/NPI mismatches, formatting issues, calculation errors, or data audit discrepancies; and affects more than 3 percent of the total number of MIPS eligible clinicians or group for which data was submitted by the third party intermediary.
This section contains our approach for public reporting on Physician Compare for year 3 of the Quality Payment Program (2019 data available for public reporting in late 2020) and future years, including MIPS, APMs, and other information as required by the MACRA and building on our previously finalized public reporting policies (see 82 FR 53819 through 53832).
Physician Compare (
As discussed in the CY 2018 Quality Payment Program final rule (82 FR 53820), Physician Compare has continued to pursue a phased approach to public reporting under the MACRA in accordance with section 1848(q)(9) of the Act. Generally, all data available for public reporting on Physician Compare must meet our established public reporting standards under § 414.1395(b). In addition, 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 under § 414.1395(d). All data available for public reporting—measure rates, scores, and attestations, objectives, etc.—are available for review and correction during the targeted review process. See the CY 2018 Quality Payment Program final rule for details on this process (82 FR 53820).
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 Medicare beneficiaries under Title XVIII of the Act. In accordance with section 104(e) of the MACRA, we finalized a policy in the CY 2016 PFS final rule (80 FR 71131) to add utilization data to the Physician Compare downloadable database.
We believe section 10331 of the Affordable Care Act supports the overarching goals of the MACRA by providing the public with performance 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, the following sections discuss the information previously finalized for inclusion on Physician Compare for all program years, as well as our finalized policies for public reporting on Physician Compare for year 3 of the Quality
We received several miscellaneous comments, but since these were not applicable to specific proposals made, these comments are outside the scope of this section and the proposed rule.
In the CY 2018 Quality Payment Program final rule (82 FR 53823), we finalized a policy to publicly report on Physician Compare, either on profile pages or in the downloadable database, the final score for each MIPS eligible clinician and the performance of each MIPS eligible clinician for each performance category, and to 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, as technically feasible, for all future years. We will use statistical testing and user testing, as well as consultation with the Physician Compare Technical Expert Panel convened by our contractor, to determine how and where these data are best reported on Physician Compare.
A summary of the previously finalized policies related to each performance category of MIPS data, as well as finalized policies for year 3 and future years, follows. It is important to note just because performance information is available for public reporting, it does not mean all data under all performance categories will be included on either public-facing profile pages or the downloadable database. These data must meet the public reporting standards, first. And, second, we are careful to ensure that we do not include too much information on public-facing profile pages in an effort not to overwhelm website users. Although all information submitted under MIPS is technically available for public reporting, we will continue our phased approach to making this information public.
In the CY 2018 Quality Payment Program final rule (82 FR 53824), we finalized a policy to make all measures under the MIPS quality performance category available for public reporting on Physician Compare, either on profile pages or in the downloadable database, as technically feasible. This includes all available measures across all collection types for both MIPS eligible clinicians and groups, for all future years. We will use statistical testing and website user testing to determine how and where measures are reported on Physician Compare. We will not publicly report first year quality measures, meaning any measure in its first year of use in the quality performance category, under § 414.1395(c). We will also include the total number of patients reported on for each measure included in the downloadable database (82 FR 53824).
We proposed to modify § 414.1395(b) to reference “collection types” instead of “submission mechanisms” to accurately update the terminology (83 FR 35987), consistent with the proposal to add this term and its definition under § 414.1305. We also proposed to revise § 414.1395(c) to indicate that we will not publicly report first year quality measures for the first 2 years a measure is in use in the quality performance category (83 FR 35987). We proposed this change to encourage clinicians and groups to report new measures, get feedback on those measures, and learn from the early years of reporting measures before measure are made public. We requested comment on these proposals.
The following is a summary of the comments we received on these proposals and our responses.
Regarding the comments supporting data transparency, we agree that for public reporting to be meaningful to all stakeholders, transparency is key. Each year we strive to actively share information, via the Physician Compare
After consideration of the comments, we are finalizing our proposal to revise § 414.1395(c) to indicate that we will not publicly report first year quality measures for the first 2 years a measure is in use in the quality performance category. We did not receive any comments on changing “submission mechanism” to “collection type” for the purposes of public reporting, and as a result are finalizing our proposal to modify § 414.1395(b) to reference “collection types” instead of “submission mechanisms”.
In the CY 2018 Quality Payment Program final rule (82 FR 53825), we finalized a policy to include on Physician Compare a subset of cost measures that meet the public reporting standards at § 414.1395(b), either on profile pages or in the downloadable database, if technically feasible, for all future years. This includes all available cost measures, and applies to both MIPS eligible clinicians and groups. We will use statistical testing and website user testing to determine how and where measures are reported on Physician Compare. We previously finalized that we will not publicly report first year cost measures, meaning any measure in its first year of use in the cost performance category, under § 414.1395(c).
Consistent with our proposal for first year quality measures, we proposed to revise § 414.1395(c) to indicate that we will not publicly report first year cost measures for the first 2 years a measure is in use in the cost performance category (83 FR 35987). We proposed this change to help clinicians and groups get feedback on these measures and learn from the early years of these new measures being calculated before measure are made public (83 FR 35987). We requested comment on this proposal.
The following is a summary of the comments we received on this proposal and our responses.
After consideration of the comments, we are finalizing our proposal to revise § 414.1395(c) to indicate that we will not publicly report first year cost measures for the first 2 years a measure is in use.
In the CY 2018 Quality Payment Program final rule (82 FR 53826), we finalized a policy to include a subset of improvement activities information on Physician Compare, either on the profile pages or in the downloadable database, if technically feasible, for all future years. This includes all available activities reported via all available collection types, and applies to both MIPS eligible clinicians and groups. For those eligible clinicians and groups that successfully meet the improvement activities performance category requirements, this information will be posted on Physician Compare as an indicator. We also finalized for all future years to publicly report first year activities if all other public reporting criteria are satisfied.
In the CY 2018 Quality Payment Program final rule (82 FR 53827), we finalized a policy to include an indicator on Physician Compare for any eligible clinician or group who successfully meets the Promoting Interoperability performance category, as technically feasible, for all future years. “Successful” performance is defined as obtaining the base score of 50 percent (82 FR 53826). We also finalized a policy to include on Physician Compare, either on the profile pages or in the downloadable database, as technically feasible, additional information, including, but not limited to, objectives, activities, or measures specified in the CY 2018 Quality Payment Program final rule (82 FR 53827; see 82 FR 53663 through 53688). This includes all available objectives, activities, or measures reported via all available collection types, and applies to both MIPS eligible clinicians and groups (82 FR 53827). We will use statistical testing and website user testing to determine how and where objectives, activities, and measures are reported on Physician Compare. We also finalized for all future years to publicly report first year Promoting Interoperability objectives, activities, and measures if all other public reporting criteria are satisfied.
In addition, we finalized that we will indicate “high” performance, as technically feasible and appropriate, in year 2 of the Quality Payment Program (2018 data available for public reporting in late 2019). “High” performance is defined as obtaining a score of 100 percent (82 FR 53826 through 53827).
As the Quality Payment Program progresses into year 3, and consistent with our work to simplify the requirements under the Promoting Interoperability performance category of MIPS, we proposed not to include the indicator of “high” performance and to maintain only an indicator for “successful” performance in the Promoting Interoperability performance category beginning with year 2 of the Quality Payment Program (2018 data available for public reporting in late 2019) (83 FR 35988). Not including the “high” performance indicator while maintaining the “successful” performance indicator continues to provide useful information to patients and caregivers without burdening website users with the additional complexity of accurately differentiating between “successful” and “high” performance, as this proved difficult for users in testing. User testing to date shows that website users value this information overall, however, as they appreciate knowing clinicians and groups are effectively using EHR technology to improve care quality (83 FR 35988).
We requested comment on our proposal not to include the indicator for “high” performance in the Promoting Interoperability performance category beginning with year 2 of the Quality Payment Program (2018 data available for public reporting in late 2019) (83 FR 35988).
The following is a summary of the comments we received on our proposal and our responses.
After consideration of the public comments received, we are finalizing our proposal to not include the indicator of “high” performance and to maintain only an indicator for “successful” performance in the Promoting Interoperability performance category beginning with year 2 of the Quality Payment Program. We note that in the CY 2017 Quality Payment Program final rule (81 FR 77397), we finalized a policy to include, as technically feasible, additional indicators, including but not limited to indicators such as, identifying if the eligible clinician or group scores high performance in patient access, care coordination and patient engagement, or health information exchange. We have since determined that it is not technically feasible to include an indicator of “high” performance that meets our public reporting standards as defined at § 414.1395(b) for year 1 of the Quality Payment Program. The reason we are not reporting this indicator, is because based upon conducting analysis against our public reporting standards, the scoring variability in the Promoting Interoperability performance category of the Quality Payment Program (year 1 to year 3) creates challenges that we are still uncovering for making the data useful to Physician Compare's primary patient and caregiver audience. Additionally, in reviewing the year 1 data (which was not available at the time the CY 2019 proposed rule was released) we have learned through user testing that patients and caregivers find clinician and group usage of EHR technology to generally be a meaningful indicator of quality, regardless of whether “successful” or “high” was noted. That is, including the word “high” did not result in patients and caregivers believing the clinician or group to be of higher quality than those that had the word “successful” next to their Promoting Interoperability performance category indicator. Therefore, the high performing indicator will not be reported in year 1, 2, 3 or future years of the Quality Payment Program on Physician Compare.
As noted above, we previously defined “successful” performance as obtaining the base score of 50 percent (82 FR 53826). As discussed in section III.I.3.h.(5) of this final rule, the Promoting Interoperability performance category will no longer have a base score beginning with year 3. To account for this change, we are finalizing a modified definition of “successful” performance to mean a Promoting Interoperability performance category score above zero beginning with year 3. We will include the modified indicator (above zero) for years 1, 2, and 3 to avoid confusion and preserve year-to-year comparability, and the previously finalized indicator (base score) for years 1 and 2 for transparency and consistency with our previously finalized policy, as technically feasible.
We also solicited comment on the type of EHR utilization performance information stakeholders would like CMS to consider adding to Physician Compare. This information may be considered for possible future inclusion on the website. We did not receive any comments.
Benchmarks are important to ensuring that the quality data published on Physician Compare are accurately understood. A benchmark allows website users to more easily evaluate the information published by providing a point of comparison between groups and between clinicians. In the CY 2018 Quality Payment Program final rule (82 FR 53829), we finalized a policy to use the Achievable Benchmark of Care (ABC
Benchmarks, and the resulting star rating, are valuable tools for patients and caregivers to use to best understand the performance information included on Physician Compare. Benchmarks can also help the clinicians and groups reporting performance information understand their performance relative to their peers, and therefore, help foster continuous quality improvement. In the initial years of the Quality Payment Program, we anticipated year-to-year changes in the measures available. As noted, we previously finalized a policy to determine the benchmark using the most recently available data (82 FR 53829). This ensured that a benchmark could be calculated despite potential year-to-year measure changes, but it also meant that the benchmark was not known to clinicians and groups prior to the performance period.
By year 3 of the Quality Payment Program (2019 data available for public reporting in late 2020), we expect enough year-to-year stability in the measures available for reporting across all MIPS performance categories to use historical data to produce a reliable and statistically sound benchmark for most measures, by measure and collection type (83 FR 35988). Therefore, we proposed to modify our existing policy to use the ABC
The following is a summary of the comments we received regarding our proposal to modify our existing policy to use the ABC
After consideration of the comments, we are finalizing our proposal to modify our existing policy to use the ABC
Currently, only MIPS measures are star rated on Physician Compare. QCDR measures, as that term is used in § 414.1400(e), are publicly reported as percent performance rates. As more QCDR measure data is available for public reporting, and appreciating the value of star rating the measures presented to website users, we believe star rating the QCDR measures will greatly benefit patients and caregivers as they work to make informed health care decisions. Particularly in the quality performance category, we believe that reporting all measure data in the same way will ease the burden of interpretation placed on site users and make the data more useful to them. Therefore, we proposed (83 FR 35988 through 35989) to further modify our existing policy to extend the use of the ABC
The following is a summary of the comments we received to further modify our existing policy to extend the use of the ABC
After consideration of the comments, we are finalizing our proposal to further modify our existing policy to extend the use of the ABC
In the CY 2018 Quality Payment Program final rule (82 FR 53830), we finalized a policy to make available for public reporting all data submitted voluntarily across all MIPS performance categories, regardless of collection type, by eligible clinicians and groups that are not subject to the MIPS payment adjustments, as technically feasible, for all future years. If an eligible clinician or group that is not subject to the MIPS payment adjustment chooses to submit data on quality, cost (if applicable), improvement activities, or Promoting Interoperability, these data are available for public reporting. We also finalized that during the 30-day preview period, these eligible clinicians and groups may opt out of having their data publicly reported on Physician Compare (82 FR 53830). If these eligible clinicians and groups do not opt out during the 30-day preview period, their data will be available for inclusion on Physician Compare if the data meet all public reporting standards at § 414.1395(b).
In the CY 2018 Quality Payment Program final rule (82 FR 53830), we finalized a policy to publicly report the 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, such as Track 1 Shared Savings Program Accountable Care Organizations (ACOs), as technically feasible, for all future years. We also finalized a policy to link clinicians and groups and the APMs they participate in on Physician Compare, as technically feasible.
Section 1833(z) of the Act requires that an incentive payment be made (or, in years after 2025, a different PFS update) to QPs for achieving threshold levels of participation in Advanced APMs. In the CY 2017 Quality Payment Program final rule (81 FR 77399 through 77491), we finalized the following policies:
• Beginning in payment year 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 payment years from 2019 through 2024, QPs receive a lump sum incentive payment equal to 5 percent of their prior year's estimated aggregate payments for Part B covered
• For payment years 2019 and 2020, eligible clinicians may become QPs only through participation in Advanced APMs.
• For payment years 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 final rule (82 FR 53832 through 53895), we finalized clarifications, modifications, and additional details pertaining to Advanced APMs, Qualifying APM Participant (QP) and Partial QP determinations, Other Payer Advanced APMs, Determination of Other Payer Advanced APMs, Calculation of All-Payer Combination Option Threshold Scores and QP Determinations, and Physician-Focused Payment Models (PFPMs). In the CY 2019 PFS proposed rule (83 FR 35989 through 36006), we proposed clarifications and modifications to policies that we previously finalized pertaining to Advanced APMs, QP and Partial QP determinations, Other Payer Advanced APMs, Determination of Other Payer Advanced APMs, and the Calculation of All-Payer Combination Option Threshold Scores and QP Determinations. In this CY 2019 PFS final rule, we respond to public comments on those proposals and announce our final policies.
The following is a summary of the general public comments received on Advanced APMs and our responses:
We will continue to reach out to the clinician community and others to partner in the development of ongoing education, support, and technical assistance materials and activities to help clinicians understand Quality Payment Program requirements, how to use available tools to enhance their practices, improve quality, reduce cost, and progress to participation in APMs and Advanced APMs if that is the best choice for their practice.
Some commenters suggested we provide more direct, regular feedback to the PTAC and stakeholders to ensure they can address concerns and shortcomings earlier in the development process, so that the PTAC comment and recommendation process can yield physician-led APMs that will be tested and implemented. The commenters also requested that we provide technical assistance to stakeholders working to develop proposals for the PTAC, and specifically that we make claims data available to allow for more detailed financial modeling to be part of the development process.
Many commenters requested that we establish a clear process and timeline for responding to PTAC proposals in the future. The commenters suggested that a 60-day window from the date that the Secretary receives a recommendation from the PTAC would be appropriate.
We note that while it seems unlikely that all of the features of any PTAC-reviewed proposed model will be tested exactly as presented in the proposal, certain features of proposed models may be incorporated into new or existing models. As the CMS Innovation Center launches new value-based payment and service delivery models, the PTAC's critical review of proposals will be a valuable resource. Additionally, the CMS Innovation Center will further engage with stakeholders that have submitted proposals related to new or existing models to leverage their experiences in the field.
While we will not provide technical assistance to individual stakeholders before they submit proposals, we encourage potential submitters to review the detailed responses from the Secretary to past comments and recommenations from the PTAC to guide development of their proposals. We also encourage stakeholders designing proposals to review the data resources available on the Office of the Assistance Secretary for Planning and Evaluation (ASPE) website at
We note that PTAC meets on a periodic basis to review proposals for physician-focused payment models submitted by individuals and stakeholder entities. The PTAC prepares comments and recommendations on proposals that are received, determining whether such models meet the criteria established by the Secretary for physician-focused payment models in the CY 2017 Quality Payment Program final rule with comment period (81 FR 77008, 77496-77499) and codified at § 414.1465. The PTAC's comments and recommendations generally must be discussed during their public meetings and must be submitted to the Secretary. Subsequently, the Secretary reviews the comments and recommendations submitted by PTAC and posts a detailed response to these recommendations on the CMS Innovation Center website at
In the CY 2019 PFS proposed rule, we explained that as we continue to develop the Quality Payment Program, we have identified the need to propose changes to some of the previously finalized definitions. A complete list of the original definitions is available in the CY 2017 Quality Payment Program final rule (81 FR 77537 through 77540).
In the CY 2018 Quality Payment Program final rule, to consolidate our regulations and avoid unnecessarily defining a term, we finalized removal of the defined term for “Advanced APM Entity” in § 414.1305 and replaced instances of that term throughout the regulation with “APM Entity.” Similarly, we finalized replacing “Advanced APM Entity group” with “APM Entity group” where it appears throughout our regulations (82 FR 53833). We noted that these changes were technical and had no substantive effect on our policies.
In the CY 2019 PFS proposed rule, to further consolidate our regulations and to clarify any potential ambiguity, we proposed to revise the definition of Qualifying APM Participant (QP) at § 414.1305 to provide that a QP is an eligible clinician determined by CMS to have met or exceeded the relevant QP payment amount or QP patient count threshold for the year based on participation in or with an APM Entity that is participating in an Advanced APM. The current definition of QP is based on an eligible clinician's participation in an Advanced APM Entity, which no longer is a defined term. Simply replacing the term “Advanced APM Entity” with the term “APM Entity,” as we had in the CY 2018 Quality Payment Program final rule, does not fully convey the definition of QP because, as noted at the time, an APM Entity can participate in an APM that is, or is not, an Advanced APM; and QP status is attainable only through participation in an Advanced APM (82 FR 53833). Again we note that this proposed change is technical and will not have a substantive effect on our policies.
We solicited comments on this proposal.
We did not receive any comments in response to this proposal.
We are finalizing our proposal to revise the definition of Qualifying APM Participant (QP) at § 414.1305 to provide that a QP is an eligible clinician determined by CMS to have met or exceeded the relevant QP payment amount or QP patient count threshold for the year based on participation in or with an APM Entity that is participating in an Advanced APM.
In the CY 2017 Quality Payment Program final rule (81 FR 77408), 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. An Advanced APM is an APM that:
• Requires its participants to use certified EHR technology (CEHRT) (81 FR 77409 through 77414);
• Provides for payment for covered professional services based on quality measures comparable to measures under the quality performance category under MIPS (81 FR 77414 through 77418); and
• Either requires its participating APM Entities to bear financial risk for monetary losses that are in excess of a nominal amount, or is a Medical Home Model expanded under section 1115A(c) of the Act (81 FR 77418 through 77431). We refer to this criterion as the financial risk criterion.
In the CY 2019 PFS proposed rule (83 FR 35989-35992), we included the following proposals, each of which is discussed in further detail below:
• We proposed to revise § 414.1415(a)(i) to specify that an Advanced APM must require at least 75 percent of eligible clinicians in each APM Entity use CEHRT as defined at § 414.1305 to document and communicate clinical care with patients and other health care professionals.
• We proposed to revise § 414.1415(b)(2) to clarify, effective January 1, 2020, that at least one of the quality measures upon which an Advanced APM bases the payment must either be finalized on the MIPS final list of measures, as described in § 414.1330; endorsed by a consensus-based entity; or determined by CMS to be evidenced-based, reliable, and valid.
• We also proposed to revise § 414.1415(b)(3), effective January 1, 2020, to provide that at least one
• We proposed to revise § 414.1415(c)(3)(i)(A) to maintain the generally applicable revenue-based nominal amount standard at 8 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 through 2024.
In the CY 2017 Quality Payment Program final rule, we finalized that an Advanced APM must require at least 50 percent of eligible clinicians in each APM Entity to use CEHRT as defined at § 414.1305 to document and communicate clinical care with patients and other health care professionals. Further, we proposed but did not finalize an increase to the requirement wherein Advanced APMs must require 75 percent CEHRT use in the subsequent year. Instead we maintained the 50 percent CEHRT use requirement for the second performance year and beyond and indicated that we would consider making any potential changes through future rulemaking (81 FR 77412).
In the CY 2019 PFS proposed rule, we proposed that, beginning for CY 2019, to be an Advanced APM, the APM must require at least 75 percent of eligible clinicians in each APM Entity use CEHRT as defined at § 414.1305 to document and communicate clinical care with patients and other health care professionals.
According to data collected by the Office of the National Coordinator for Health Information Technology (ONC), over 3 in 4 office-based physicians adopted a certified EHR in CY 2015,
We solicited comment on this proposal.
The following is a summary of the public comments received on this proposal and our responses:
After considering public comments, we are finalizing our proposal that, for QP Performance Periods beginning in 2019, to be an Advanced APM, the APM must require at least 75 percent of eligible clinicians in each APM Entity (or, for APMs in which hospitals are the APM Entities, each hospital, as specified in our current regulation) to use CEHRT as defined at § 414.1305 to document and communicate clinical care with patients and other health care professionals. We are amending § 414.1414(a)(1) to reflect this change.
In the CY 2017 Quality Payment Program final rule, we explained that one of the criteria for an APM to be an Advanced APM is that it must provide for payment for covered professional services based on quality measures comparable to measures under the performance category described in section 1848(q)(2)(A) of the Act, which is the MIPS quality performance category. We generally refer to these measures in the remainder of this discussion as “MIPS-comparable quality measures.” We also explained that we interpret this criterion to require the APM to incorporate quality measure results as a factor when determining
In the CY 2017 Quality Payment Program proposed rule, we proposed that to be an Advanced APM, an APM must base payment on quality measures that are evidence-based, reliable, and valid; and that at least one measure must be an outcome measure unless there is not an applicable outcome measure on the MIPS quality list at the time the APM is developed. The required outcome measure does not have to be one of those on the MIPS quality measure list. We did not specify that the outcome measure is required to be evidence-based, reliable, and valid. (81 FR 28302). We finalized these policies in the CY 2017 Quality Payment Program final rule and codified at § 414.1415(b).
In the CY 2017 Quality Payment Program final rule, we codified at § 414.1415(b)(2) that at least one of the quality measures upon which an Advanced APM bases the payment must have an evidence-based focus, be reliable, and valid, and meet at least one of the following criteria: Used in the MIPS quality performance category as described in § 414.1330; endorsed by a consensus-based entity; developed under section 1848(s) of the Act; submitted in response to the MIPS Call for Quality Measures under section 1848(q)(2)(D)(ii) of the Act; or any other quality measures that CMS determines to have an evidence-based focus and to be reliable and valid.
It has come to our attention that some have interpreted § 414.1415(b)(2) to mean that measures on the MIPS final list or submitted in response to the MIPS Call for Quality Measures necessarily are MIPS-comparable quality measures, even if they are not evidence-based, reliable, and valid. We did not intend to imply that any measure that was merely submitted in response to the annual call for quality measures or developed using Quality Payment Program funding will automatically qualify as MIPS-comparable even if the measure was never endorsed by a consensus-based entity, adopted under MIPS, or otherwise determined to be evidence-based, reliable, and valid. Although we believe such measures may be evidence-based, reliable, and valid, we did not intend to consider them so for purposes of § 414.1415(b)(2) without independent verification by a consensus-based entity, or based on our own assessment and determination, that they are evidence-based, reliable, and valid. We further believe the same principle applies to Qualified Clinical Data Registry (QCDR) measures. If QCDR measures are endorsed by a consensus-based entity they are presumptively considered MIPS-comparable quality measures for purposes of § 414.1415(b)(2); otherwise we would have needed independent verification, or to make our own assessment and determination, that the measures are evidence-based, reliable, and valid before considering them to be MIPS-comparable quality measures (see 81 FR 77415 through 77417).
Because of the potential ambiguity in the existing definition and out of an abundance of caution to avoid any adverse impact on APM entities, eligible clinicians, or other commenters, we have used the more permissive interpretation of the regulation text, wherein measures developed under section 1848(s) of the Act and submitted in response to the MIPS Call for Quality Measures will meet the quality criterion in implementing the program thus far, and intend to use this interpretation for the 2019 QP Performance Period until our new proposal described, in this final rule, is effective on January 1, 2020. Recognizing that APMs and other payer payment arrangements that we might consider for Advanced APM and Other Payer Advanced APM determinations are well into development for 2019, we proposed to amend § 414.1415(b)(2) to be effective as of January 1, 2020. Specifically, we proposed that at least one of the quality measures upon which an Advanced APM bases payment must be finalized on the MIPS final list of measures, as described in § 414.1330; be endorsed by a consensus-based entity; or otherwise determined by CMS to be evidenced-based, reliable, and valid.
That is, for QP Performance Period 2020 and all future QP Performance Periods, we would treat any measure that is either included in the MIPS final list of measures or has been endorsed by a consensus-based entity as presumptively evidence-based, reliable, and valid. All other measures would need to be independently determined by CMS to be evidence-based, reliable, and valid, to be considered MIPS-comparable quality measures.
We solicited comment on this proposal.
The following is a summary of the public comments received on this proposal and our responses:
We also note, that we believe the revised criteria for the MIPS-comparable measures used in Advanced APMs do not prevent an APM from using a core measure set or using measures developed and included in other CMS programs, but instead provides the criteria for what constitutes a MIPS-comparable measure to meet the Advanced APM requirement (81 FR 77417). Not all quality measures upon
After considering public comments, we are finalizing our proposal to revise § 414.1415(b)(2) to clarify, effective January 1, 2020, to clarify that at least one of the quality measures upon which an Advanced APM bases payment must either be finalized on the MIPS final list of measures, as described in § 414.1330; endorsed by a consensus-based entity; or determined by CMS to be evidenced-based, reliable, and valid.
In § 414.1415(b)(3), we generally require that the measures upon which an Advanced APM bases payment must include at least one outcome measure, but specify that this requirement does not apply if CMS determines that there are no available or applicable outcome measures in the MIPS quality measure lists for the Advanced APM's first QP Performance Period. We note that the current regulation does not require that the outcome measure be evidence-based, reliable, and valid. Although it was our general expectation when developing the CY 2017 Quality Payment Program final rule that outcome measures will meet this standard, we did not explicitly include this requirement.
In the CY 2019 PFS proposed rule, we proposed to modify § 414.1415(b)(3) to explicitly require that an outcome measure must be evidence-based, reliable, and valid (unless, as specified in the current regulation, there is no available or applicable outcome measure), so that at least one outcome measure used for purposes of § 414.1415(b)(1) must also be:
• Finalized on the MIPS final list of measures, as described in § 414.1330;
• Endorsed by a consensus-based entity; or
• Determined by CMS to be evidence-based, reliable, and valid.
We proposed that this change would have an effective date of January 1, 2020, and would specifically require that at least one outcome measure for which measure results are included as a factor when determining payment to participants under the terms of the APM must also be a MIPS-comparable quality measure. This is intended to align with our parallel proposal for the Other Payer Advanced APM criteria that we discuss in section III.I.4.e.(3)(d)(iii) of this final rule.
We solicited comment on this proposal.
The following is a summary of the public comments received on this proposal and our responses:
After considering public comments, we are finalizing our proposal to revise § 414.1415(b)(3), effective January 1, 2020, to require that at least one outcome measure, for which measure results are included as a factor when determining payment to participants under the terms of the APM, must either be finalized on the MIPS final list of measures as described in § 414.1330, endorsed by a consensus-based entity; or determined by CMS to be evidence-based, reliable, and valid. As specified in the current regulation, this requirement does not apply if CMS determines that there are no available or applicable outcome measures included in the MIPS quality measures list for the Advanced APM's first QP Performance Period.
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).
In the CY 2018 Quality Payment Program final rule, we finalized our proposal to maintain the generally applicable revenue-based nominal amount standard at 8 percent for the 2019 and 2020 QP Performance Periods at § 414.1415(c)(3)(i)(A). We also specified that the standard is based on the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities. We stated that we will address the nominal amount standard for QP Performance Periods after 2020 in future rulemaking (82 FR 53838).
We proposed to amend § 414.1415(c)(3)(i)(A) to maintain the generally applicable revenue-based nominal amount standard at 8 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 through 2024.
We solicited comment on this proposal.
The following is a summary of the public comments received on this proposal and our responses:
After considering public comments, we are finalizing our proposal to revise § 414.1415(c)(3)(i)(A) to maintain the generally applicable revenue-based nominal amount standard at 8 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 through 2024. We continue to believe that 8 percent of Medicare Parts A and B revenues of all providers and suppliers in participating APM Entities generally represents an appropriate standard for more than a nominal amount of financial risk at this time. We also believe that maintaining a consistent standard for several more years will help APM Entities to plan for multi-year Advanced APM participation. We further believe that maintaining a consistent standard will allow us to evaluate how APM Entities succeed within these parameters over the applicable timeframe.
We also sought comment on whether, as APM entities and participating eligible clinicians grow more comfortable with assuming risk, we should consider increasing the nominal amount standard. Specifically, we requested comments on whether we should consider raising the revenue-based nominal amount standard to 10 percent, and the expenditure-based nominal amount standard to 4 percent starting for QP Performance Periods in 2025 and later.
Several comments stated we should consider raising the revenue-based nominal amount standard to 10 percent, and the expenditure-based nominal amount standard to 4 percent starting for QP Performance Periods in 2025 and later. We thank commenters for their feedback and will take this input into consideration for future years.
• We are finalizing revisions to § 414.1415(a)(i) to specify that an Advanced APM must require at least 75 percent of eligible clinicians in each APM Entity, or, for APMs in which hospitals are the APM Entities, each hospital, to use CEHRT as defined at § 414.1305 to document and communicate clinical care with patients and other health care professionals.
• We are finalizing revisions to clarify at § 414.1415(b)(2), effective January 1, 2020, that at least one of the quality measures upon which an Advanced APM bases the payment in paragraph (b)(1) of this section must either be finalized on the MIPS final list of measures, as described in § 414.1330; endorsed by a consensus-based entity; or determined by CMS to be evidenced-based, reliable, and valid.
• We are finalizing revisions at § 414.1415(b)(3), effective January 1, 2020, to provide that at least one outcome measure, for which measure results are included as a factor when determining payment to participants under the terms of the APM must either be finalized on the MIPS final list of measures as described in § 414.1330, endorsed by a consensus-based entity; or determined by CMS to be evidence-based, reliable, and valid.
• We are finalizing revisions at § 414.1415(c)(3)(i)(A) to maintain the generally applicable revenue-based nominal amount standard at 8 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 through 2024.
We finalized policies relating to QP and Partial QP determinations in the CY 2017 Quality Payment Program final rule (81 FR 77433 through 77450).
In the CY 2019 PFS proposed rule (83 FR 3599 through 35994), we included the following proposals, each of which is discussed in further detail below:
• We proposed that for each of the three QP determinations, we will allow for claims run-out for 60 days (approximately 2 months), before calculating the Threshold Scores so that the three QP determinations can be completed approximately 3 months after the end of that determination time period.
• We proposed that when an eligible clinician is determined to be a Partial QP for a year at the individual eligible clinician level, the individual eligible clinician will make an election whether to report to MIPS. If the eligible clinician elects to report to MIPS, they will be subject to the MIPS reporting requirements and payment adjustment. If the eligible clinician elects not to report, they will be excluded from the MIPS reporting requirements and payment adjustment. In the absence of an explicit election to report to MIPS, the eligible clinician will be excluded from the MIPS reporting requirements and payment adjustment. This means that no actions other than the eligible clinician's affirmative election to participate in MIPS will result in that eligible clinician becoming subject to the MIPS reporting requirements and payment adjustment.
In the CY 2017 Quality Payment Program final rule, we finalized for the timing of QP determinations that a QP Performance Period runs from January 1 through August 31 of the calendar year that is 2 years prior to the payment year (81 FR 77446-77447). During that QP Performance Period, we will make QP determinations at three separate snapshot dates (March 31, June 30, and August 31), each of which will be a final determination for the eligible clinicians who are determined to be QPs. The QP Performance Period and the three
We also finalized that for each of the three QP determinations, we will allow for claims run-out for 3 months, or 90 days, before calculating the Threshold Scores so that QP determinations will be completed approximately 4 months after each snapshot date. As a result, the last of these three QP determinations is complete on or around January 1 of the subsequent calendar year, which is the year immediately prior to the MIPS payment year. For most MIPS data submission types, January 1 of the subsequent calendar year is also the beginning of the MIPS data submission period. This way, eligible clinicians know of their QP status prior to or near the beginning of the MIPS data submission period and know whether they should report any performance period data to MIPS for the applicable MIPS payment year.
Upon further consideration and based on our experience implementing the program to date, we believe providing eligible clinicians notification of their QP status more quickly after each of the three QP determination snapshot dates, and prior to the beginning of the MIPS data submission period after the last determination, will potentially reduce burden for eligible clinicians and APM Entities while improving their overall experience participating in the program.
We proposed that beginning in 2019 for each of the three QP determination dates, we will allow for claims run-out for 60 days (approximately 2 months), before calculating the Threshold Scores so that the three QP determinations will be completed approximately 3 months after the end of that determination time period. We note that this proposal does not affect the QP Performance Period per se, but rather the date by which claims for services furnished during the QP Performance Period will need to be processed for those services to be included in calculating the Threshold Scores. To the extent that claims are used for calculating the Threshold Scores, such claims will have to be processed by no later than 60 days after each of the three QP determination dates, for information on the claims to be included in our calculations.
We solicited comment on this proposal.
The following is a summary of the public comments received on this proposal and our responses:
After considering public comments, we are finalizing our proposal that for each of the three QP determinations, we will allow for claims run-out for 60 days (approximately 2 months), before calculating the Threshold Scores so that the three QP determinations can be completed approximately 3 months after the end of that determination time period.
Section 1848(q)(1)(C)(ii)(II) of the Act excludes from the definition of MIPS eligible clinician an eligible clinician who is a Partial QP for a year and who does not report on applicable measures and activities as required under MIPS for the year. However, under section 1848(q)(1)(C)(vii) of the Act, an eligible clinician who is a Partial QP for a year and reports on applicable measures and activities as required under the MIPS is considered to be a MIPS eligible clinician for the year.
In the CY 2017 Quality Payment Program final rule, we finalized that following a determination that eligible clinicians in an APM Entity group in an Advanced APM are Partial QPs for a year, the APM Entity will make an election whether to report on applicable measures and activities as required under MIPS. If the APM Entity elects to report to MIPS, all eligible clinicians in the APM Entity will be subject to the MIPS reporting requirements and payment adjustments for the relevant year. If the APM Entity elects not to report, all eligible clinicians in the APM Entity group will be excluded from the MIPS reporting requirements and payment adjustments for the relevant year (81 FR 77449).
We also finalized that in cases where the Partial QP determination is made at the individual eligible clinician level, if the individual eligible clinician is determined to be a Partial QP, the eligible clinician will make the election whether to report on applicable measures and activities as required under MIPS and, as a result, be subject to the MIPS reporting requirements and payment adjustment (81 FR 77449). If the individual eligible clinician elects to report to MIPS, he or she will be subject to the MIPS reporting requirements and payment adjustments for the relevant year. If the individual eligible elects not to report to MIPS, he or she will be excluded from the MIPS reporting requirements and payment adjustments for the relevant year. We note that QP determinations are made at the individual eligible clinician level when the clinician is identified as participating in an Advanced APM on an Affiliated Practitioner List rather than a Participation List, or when an eligible clinician is in more than one APM Entity group in one or more Advanced APMs, and does not achieve QP status as part of any single APM Entity group (see § 414.1425(b)(2) and (c)(4) our regulations).
We also clarified how we consider the absence of an explicit election to report to MIPS or to be excluded from MIPS. We finalized that for situations in which the APM Entity is responsible for making the decision on behalf of all eligible clinicians in the APM Entity group, the group of Partial QPs will not be considered MIPS eligible clinicians unless the APM Entity opts the group into MIPS participation, so that no actions other than the APM Entity's election for the group to participate in MIPS will result in MIPS participation (81 FR 77449).
For eligible clinicians who are determined to be Partial QPs individually, we finalized that we will use the eligible clinician's actual MIPS reporting activity to determine whether to exclude the Partial QP from MIPS in the absence of an explicit election. Therefore, if an eligible clinician who is individually determined to be a Partial QP submits information to MIPS (not including information automatically populated or calculated by CMS on the Partial QP's behalf), we will consider the Partial QP to have reported, and thus to be participating in MIPS. Likewise, if such an individual does not take any action to submit information to MIPS, we will consider the Partial QP to have elected to be excluded from MIPS (81 FR 77449).
We proposed that when an eligible clinician is determined to be a Partial QP for a year at the individual eligible clinician level, the individual eligible clinician will make an election whether to report to MIPS. If the eligible clinician elects to report to MIPS, they will be subject to MIPS reporting requirements and payment adjustments. If the eligible clinician elects to not report to MIPS, they will not be subject to the MIPS reporting requirements and payment adjustment. If the eligible clinician does not make any election, they will not be subject to the MIPS reporting requirements and payment adjustment.
We note that this proposed policy change would affect only situations where the Partial QP makes no election to either report to MIPS or to be excluded from the MIPS reporting requirements and payment adjustment. Under our proposed policy, all Partial QPs retain the full right to affirmatively decide through the election process whether or not to be subject to the MIPS reporting requirements and payment adjustment; whereas, if the Partial QP does not make any election, they will not be subject to the MIPS reporting requirements and payment adjustment.
We solicited comment on this proposal.
The following is a summary of the public comments received on this proposal and our responses:
The commenter suggested an alternative approach where CMS would apply the policy which yields the most advantageous MIPS final score and subsequently the most advantageous MIPS payment adjustment. The commenter noted that this alternative approach would work in such a manner that in cases where data is submitted by a Partial QP, or on their behalf, that would earn the Partial QP a MIPS final score resulting in a positive MIPS payment adjustment, CMS would use that data to provide them a MIPS final score, regardless of whether they made an election to participate in MIPS. In cases where data is submitted by a Partial QP, or on their behalf, that would earn the Partial QP a MIPS final score resulting in a negative MIPS payment adjustment, CMS would not use that data to provide them a MIPS final score, and they would be exempt from MIPS based on the Partial QP status.
The commenter noted this alternative approach would eliminate all potential unintended consequences and would be consistent with other CMS policies to use data that yields the most advantageous result. The commenter also noted the alternative approach may further incentivize participation in APMs and reduce burden on both eligible clinicians and CMS because eligible clinicians would no longer have to make an election to affirmatively opt-in or opt-out of MIPS.
After considering public comments, we are finalizing our proposal that when an eligible clinician is determined to be a Partial QP for a year at the individual eligible clinician level, the individual eligible clinician will make an election whether to report to MIPS. If the eligible clinician elects to report to MIPS, they will be subject to the MIPS reporting requirements and payment adjustment. If the eligible clinician elects not to report, they will be excluded from the MIPS reporting requirements and payment adjustment. In the absence of an explicit election to report to MIPS, the eligible clinician will be excluded from the MIPS reporting requirements and payment adjustment. This means that no actions other than the eligible clinician's affirmative election to participate in MIPS would result in that eligible clinician becoming subject to the MIPS reporting requirements and payment adjustment.
In this section, we are finalizing the following policies:
• We are finalizing our proposal that for each of the three QP determinations, we will allow for claims run-out for 60 days (approximately 2 months), before calculating the Threshold Scores so that the three QP determinations can be completed approximately 3 months after the end of that determination time period.
• We are finalizing our proposal that when an eligible clinician is determined to be a Partial QP for a year at the individual eligible clinician level, the individual eligible clinician will make an election whether to report to MIPS. If the eligible clinician elects to report to MIPS, they will be subject to the MIPS reporting requirements and payment adjustment. If the eligible clinician elects not to report, they will be excluded from the MIPS reporting requirements and payment adjustment. In the absence of an explicit election to report to MIPS, the eligible clinician will be excluded from the MIPS reporting requirements and payment adjustment. This means that no actions other than the eligible clinician's affirmative election to participate in MIPS would result in that eligible clinician becoming subject to the MIPS reporting requirements and payment adjustment.
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 QP 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 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 that satisfy the Other Payer Advanced APM criteria with payers other than Medicare. 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 of the CY 2017 Quality Payment Program final rule (81 FR 77460 through 77461). We also finalized that, in making QP determinations with respect to an eligible clinician, we will use the Threshold Score that is most advantageous to the eligible clinician toward achieving QP status, 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 information about the payment arrangement 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 certain information from an external source.
In the CY 2018 Quality Payment Program final rule, we established additional policies to implement the All-Payer Combination Option and finalized certain modifications to our previously finalized policies (82 FR 53844 through 53890). A detailed summary of those policies can be found at 82 FR 53874 through 53876 and 53890 through 53891. In relevant part, we finalized the following:
• We finalized at § 414.1445(a) and (b)(1) that certain other payers, including payers with payment arrangements authorized under Title XIX (the Medicaid statute), Medicare Health Plan payment arrangements, and payers with payment arrangements aligned with a CMS Multi-Payer Model, can 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 finalized that Remaining Other Payers, including
• We finalized at § 414.1445(a) and (b)(2) 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 can be used to submit requests for determinations before the beginning of a QP Performance Period for other payer arrangements authorized under Title XIX. The Eligible Clinician Initiated Process is available for the 2019 QP Performance Period and each year thereafter.
• We finalized that, for each other payer arrangement for which a payer requests us to make an Other Payer Advanced APM determination, the payer must complete and submit the Payer Initiated Submission Form by the relevant Submission Deadline.
• We finalized that, for each other payer arrangement for which an APM Entity or eligible clinician requests us to make an Other Payer Advanced APM determination, the APM Entity or eligible clinician must complete and submit the Eligible Clinician Initiated Submission Form by the relevant Submission Deadline.
• We removed the requirement, previously established at § 414.1445(b)(3), that payers must attest to the accuracy of information submitted by eligible clinicians, and we also removed the related attestation requirement at § 414.1460(c). Instead, we finalized an additional requirement at § 414.1445(d) that an APM Entity or eligible clinician that submits information under § 414.1445(c) must certify that, to the best of its knowledge, the information it submits to us is true, accurate, and complete.
• We finalized at § 414.1440(e) 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 finalized at § 414.1440(d)(1) that we will make QP determinations under the All-Payer Combination Option based on eligible clinicians' participation in Advanced APMs and Other Payer Advanced APMs for three time periods of the QP Performance Period: January 1 through March 31; January 1 through June 30; and January 1 through August 31. We finalized that we will use patient or payment data for the same time periods to calculate both the Medicare and the other payer portion of the Threshold Score calculation under the All-Payer Cominbation Option.
• We finalized at § 414.1440(e)(4) that, to request a QP determination under the All-Payer Combination Option, APM Entities or eligible clinicians must submit all of 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.
In this section of the final rule, we address policies within the following topics: Other Payer Advanced APM Criteria; Other Payer Advanced APM determinations; and Calculation of the All-Payer Combination Option Threshold Scores and QP Determinations.
In the CY 2019 PFS proposed rule (83 FR 35999-36006), we included the following proposals, each of which is discussed below:
• We proposed to change the CEHRT use criterion so that in order to qualify as an Other Payer Advanced APM as of January 1, 2020, the other payer arrangement must require at least 75 percent of participating eligible clinicians in each APM Entity use CEHRT.
• We proposed to allow payers and eligible clinicians to submit evidence as part of their request for an Other Payer Advanced APM determination that CEHRT is used by the requisite percentage of eligible clinicians participating in the payment arrangement (50 percent for 2019, and 75 percent for 2020 and beyond) to document and communicate clinical care, whether or not CEHRT use is explicitly required under the terms of the payment arrangement.
• We proposed the following clarification to § 414.1420(c)(2), effective January 1, 2020, to provide that at least one of the quality measures used in the payment arrangement in paragraph (c)(1) of this regulation must be:
++ Finalized on the MIPS final list of measures, as described in § 414.1330;
++ Endorsed by a consensus-based entity; or
++ Determined by CMS to be evidenced-based, reliable, and valid.
• We proposed to revise § 414.1420(c)(3) to require that, effective January 1, 2020, unless there is no applicable outcome measure on the MIPS quality measure list, an Other Payer Advanced APM must use an outcome measure, that must be:
++ Finalized on the MIPS final list of measures, as described in § 414.1330;
++ Endorsed by a consensus-based entity; or
++ Determined by CMS to be evidenced-based, reliable, and valid.
• We also proposed to revise our regulation at § 414.1420(c)(3)(i) to provide that, for payment arrangements determined to be Other Payer Advanced APMs for the 2019 performance year that did not include an outcome measure that is evidence-based, reliable, and valid, and that are resubmitted for an Other Payer Advanced APM determination for the 2020 performance year (whether for a single year, or for a multi-year determination as proposed in section III.I.4.e.(4)(b) of this final rule), we would continue to apply the current regulation for purposes of those determinations. This proposed revision also applies to payment arrangements in existence prior to the 2020 performance year that are submitted for determination to be Other Payer Advanced APMs for the 2020 performance year and later.
• We proposed details regarding the Payer Initiated Process for Remaining Other Payers. To the extent possible, we aligned the Payer Initiated Process for Remaining Other Payers with the previously finalized Payer Initiated Process for Medicaid, Medicare Health Plans, and CMS Multi-Payer Models.
• We proposed to eliminate the Payer Initiated Process that is specifically for CMS Multi-Payer Models. We believe that payers aligned with CMS Multi-Payer Models can submit their arrangements through the Payer Initiated Process for Remaining Other Payers proposed in section III.I.4.e.(4)(c) of this final rule, or through the Medicaid or Medicare Health Plan payment arrangement submission processes.
• We proposed to add a third alternative to allow requests for QP determinations at the TIN level in instances where all clinicians who reassigned billing rights under the TIN participate in a single APM Entity. We proposed to modify our regulation at § 414.1440(d) by adding this third alternative to allow QP determinations at the TIN level in instances where all clinicians who have reassigned billing under the TIN participate in a single APM Entity, as well as to assess QP status at the most advantageous level for each eligible clinician.
• We also clarified that, in making QP determinations using the All-Payer Combination Option, eligible clinicians may meet the minimum Medicare threshold using one method, and the All-Payer threshold using the same or a different method. We proposed to codify this clarification by adding § 414.1440(d)(4).
• We proposed to extend the weighting methodology that is used to ensure that an eligible clinician does not receive a lower score on the Medicare portion of their all-payer calculation under the All-Payer Combination Option than the Medicare Threshold Score they received at the APM Entity level in order to apply a similar policy to the proposed TIN level Medicare Threshold Scores.
In general, 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 helps simplify the Quality Payment Program and encourage participation in Other Payer Advanced APMs (82 FR 53847).
Some stakeholders have requested that we take into account “business risk” costs such as IT, personnel, and other administrative costs associated with APM Entities' participation in Other Payer Advanced APMs when implementing the financial risk standard. We did not propose to modify our financial risk standard in response to this suggestion, and note that financial risk in the context of Other Payer Advanced APMs is defined both in the Act (at section 1833(z)(2)(B)(iii)(II)(cc) for payment years 2021 and 2022, and section 1833(z)(3)(B)(iii)(II)(cc) for subsequent years) and our regulations at § 414.1420(d) so as to require that APM Entities in the payment arrangement must assume financial risk when actual expenditures exceed expected expenditures. However, we note that a payment arrangement with an other payer, like some APMs, can be structured so that the APM provides an investment payment to the participating APM Entities to assist with the practice transformation that may be required for participation in the payment arrangement. This investment payment could be structured in various ways; for example, it could be structured similarly to the Medicare ACO Investment Model under, which expected shared savings payment were pre-paid to encourage new ACOs to form in rural and underserved areas and to assist existing ACOs in meeting certain criteria; or it could be structured so that the payment is made specifically to encourage participating APM Entities to continue to make staffing, infrastructure, and operations investments as a means of practice transformation; or it could have a different structure entirely.
Although CMS did not solicit comments regarding our statement on investment payments, the following is a summary of the public comments we received:
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, or each hospital if hospitals are the APM Entities, to use CEHRT to document and communicate clinical care (81 FR 77465). This CEHRT use criterion directly paralleled the criterion established for Advanced APMs in § 414.1415(a)(1)(i).
In the CY 2018 Quality Payment Program final rule, we finalized that we would presume that an other payer arrangement meets 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 to use CEHRT to document and communicate clinical care (see § 414.1445(c)(2)).
We proposed to change the current CEHRT use criterion for Other Payer
According to data collected by ONC, since the CY 2017 Quality Payment Program final rule was published, EHR adoption has been widespread, and we want to encourage continued adoption. Additionally, in response to the CY 2017 Quality Payment Program proposed rule stakeholders encouraged us to raise the CEHRT use criterion to 75 percent (see 81 FR 77411). We believe that this proposed change aligns with the increased adoption of CEHRT among providers and suppliers that is already happening, and will encourage further CEHRT adoption. (83 FR 35990).
We solicited comment on this proposal.
The following is a summary of the public comments received in response to our request for comment and our responses:
After considering public comments, we are finalizing our proposal to change the current CEHRT use criterion for Other Payer Advanced APMs so that in order to qualify as an Other Payer Advanced APM as of January 1, 2020, the other payer arrangement must require at least 75 percent of participating eligible clinicians in each APM Entity to use CEHRT.
In the CY 2017 Quality Payment Program final rule, we adopted a CEHRT use criterion for Other Payer Advanced APMs that directly paralleled the CEHRT use criterion for Advanced APMs wherein Other Payer Advanced APMs must require at least 50 percent of 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.
We have since heard from payers and other stakeholders that CEHRT is often used under other payer arrangements even if it is not expressly required under the payment arrangement. Because CEHRT use is increasingly common among eligible clinicians, payers may not believe it is necessary to specifically require the use of CEHRT under the terms of an Other Payer payment arrangement.
Given this, we believe our current policy may needlessly exclude certain existing payment arrangements that could meet the statutory requirements for Other Payer Advanced APMs—including some where the majority of eligible clinicians use CEHRT, even if they are not explicitly required to do so under the terms of their payment arrangements.
We proposed that a payer or eligible clinician must provide documentation to CMS that CEHRT is used to document and communicate clinical care under the payment arrangement by at least 50 percent of eligible clinicians in 2019, and 75 percent of the eligible clinicians in 2020 and beyond, whether or not such CEHRT use is explicitly required under the terms of the payment arrangement. We specifically proposed to modify the regulation at § 414.1420(b) to specify that to be an Other Payer Advanced APM, CEHRT must be used by at least 50 percent of eligible clinicians participating in the arrangement in 2019 (or, beginning in 2020, 75 percent) of such eligible clinicians).
We solicited comment on this proposal.
The following is a summary of the public comments received in response to our request for comment and our responses:
After considering public comments, we are finalizing our proposal that a payer or eligible clinician must provide documentation to CMS that CEHRT is used to document and communicate clinical care under the payment arrangement by at least 50 percent of eligible clinicians in 2019, and 75 percent of the eligible clinicians in 2020 and beyond, whether or not such CEHRT use is explicitly required under the terms of the payment arrangement. Specifically, we are finalizing our proposal to modify the regulation at § 414.1420(b) to specify that to be an Other Payer Advanced APM, CEHRT must be used by at least 50 percent of eligible clinicians participating in the arrangement in 2019 (or, beginning in 2020, 75 percent) of such eligible clinicians.
In the CY 2017 Quality Payment Program final rule, we explained that one of the criteria for a payment arrangement to be an Other Payer Advanced APM is that it must apply quality measures comparable to those under the MIPS quality performance category (81 FR 77465).
In the CY 2017 Quality Payment Program proposed rule, we proposed that to be an Other Payer Advanced APM, a payment arrangement must have quality measures that are evidence-
In the CY 2017 Quality Payment Program final rule, we codified at § 414.1420(c)(2) that at least one of the quality measures used in the payment arrangement with an APM Entity must have an evidence-based focus, be reliable, and valid, and meet at least one of the following criteria:
• Used in the MIPS quality performance category as described in § 414.1330;
• Endorsed by a consensus-based entity;
• Developed under section 1848(s) of the Act;
• Submitted in response to the MIPS Call for Quality Measures under section 1848(q)(2)(D)(ii) of the Act; or
• Any other quality measures that CMS determines to have an evidence-based focus and to be reliable and valid.
It has come to our attention that, as with the comparable policy for Advanced APMs as discussed at 81 FR 28302, some have read the regulation at § 414.1420(c)(2) to mean that measures on the MIPS final list or submitted in response to the MIPS Call for Quality Measures necessarily are MIPS-comparable quality measures, even if they have not been determined to be evidence-based, reliable, and valid. We did not intend to imply that any measure that was merely submitted in response to the annual call for quality measures or developed using Quality Payment Program funding would automatically qualify as MIPS-comparable regardless of whether the measure was endorsed by a consensus-based entity, adopted under MIPS, or otherwise determined to be evidence-based, reliable, and valid. While we believe such measures may be evidence-based, reliable, and valid, we did not intend to consider them so for purposes of § 414.1420(c)(2) without independent verification by a consensus-based entity or based on our own assessment and determination that they are evidence-based, reliable, and valid. We further believe the same principle applies to QCDR measures. If QCDR measures are endorsed by a consensus-based entity they are presumptively considered MIPS-comparable quality measures for purposes of § 414.1420(c)(2); otherwise we would have needed independent verification, or to make our own assessment and determination, that the measures are evidence-based, reliable, and valid before considering them to be MIPS-comparable (see 81 FR 77415 through 77417).
Because of the potential ambiguity in the existing definition and out of an abundance of caution in order to avoid any adverse impact on APM entities, eligible clinicians or other stakeholders, we have used the more permissive interpretation of the text, wherein measures developed under section 1848(s) of the Act and submitted in response to the MIPS Call for Quality Measures will meet the quality criterion in implementing the program thus far, and intend to use this interpretation for the 2019 QP Performance Period. Recognizing that APMs and other payer arrangements that we might consider for Advanced APM and Other Payer Advanced APM determinations are well into development for 2019, we proposed to use this interpretation until our new proposal described below is effective on January 1, 2020.
Therefore, at § 414.1420(c)(2), we proposed, effective January 1, 2020, that at least one of the quality measures used in the payment arrangement with an APM Entity must meet at least one of the following criteria:
• Finalized on the MIPS final list of measures, as described in § 414.1330;
• Endorsed by a consensus-based entity; or
• Otherwise determined by CMS to be evidenced-based, reliable, and valid.
That is, for QP Performance Period 2020 and all future QP Performance Periods, we would treat any measure that is either included in the MIPS final list of measures or has been endorsed by a consensus-based entity as presumptively evidence-based, reliable, and valid. All other measures would need to be independently determined by CMS to be evidence-based, reliable, and valid, in order to be considered MIPS-comparable quality measures.
We solicited comment on this proposal.
The following is a summary of the public comments received in response to our request for comment and our responses:
After considering public comments, we are finalizing our proposal to revise § 414.1420(c)(2) to clarify, effective as of January 1, 2020, that at least one of the quality measures used in the payment arrangement with an APM Entity must either be finalized on the MIPS final list of measures, as described in § 414.1330; endorsed by a consensus-based entity; or determined by CMS to be evidenced-based, reliable, and valid.
In § 414.1420(c)(3), we generally require that, to be an Other Payer Advanced APM, the payment arrangement must use an outcome measure if there is an applicable outcome measure on the MIPS quality measure list. We note that the current regulation does not require that the outcome measure be evidence-based, reliable, and valid.
We proposed to revise § 414.1420(c)(3), to explicitly require that, unless there is no applicable
• Finalized on the MIPS final list of measures, as described in § 414.1330;
• Endorsed by a consensus-based entity; or
• Determined by CMS to be evidence-based, reliable, and valid.
The proposal would have an effective date of January 1, 2020. This proposed effective date is intended to provide stakeholders sufficient notice of, and opportunity to respond to, this change in our regulation because the current regulation does not explicitly require that an outcomes measures must be evidence-based, reliable, and valid and, as a result some Other Payer Advanced APMs that were submitted for determination in CY 2018 for the CY 2019 performance year may not include outcomes measures that are evidence-based, reliable, and valid.
We also proposed that, for such payment arrangements that are determined to be Other Payer Advanced APMs for the 2019 performance year and did not include an outcome measure that is evidence-based, reliable, and valid, and that are resubmitted for an Other Payer Advanced APM determination for the 2020 performance year (whether for a single year, or for a multi-year determination as proposed in section III.I.4.e.(4)(b) of this final rule), we will continue to apply the current regulation for purposes of those determinations. Additionally, payment arrangements in existence prior to the 2020 performance year that are submitted for determination to be Other Payer Advanced APMs for the 2020 performance year and later, will be assessed under the rules of the current regulation meaning they do not need to include an outcome measure that is evidence-based, reliable, and valid to be an Other Payer Advanced APM. For all other payment arrangements the proposed revised regulation would apply beginning in CY 2020.
We solicited comment on this proposal.
The following is a summary of the public comments received in response to our request for comment and our responses:
After considering public comments, we are finalizing our proposal to revise § 414.1420(c)(3), effective January 1, 2020, to explicitly require that, unless there is no applicable outcome measure on the MIPS quality measure list, at least one outcome measure that applies in the payment arrangement must either be finalized on the MIPS final list of measures as described in § 414.1330, endorsed by a consensus-based entity, or determined by CMS to be evidence-based, reliable, and valid.
In the CY 2018 Quality Payment Program final rule, we finalized our proposal 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 finalized 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 is 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 proposed to amend § 414.1420(d)(3)(i) to maintain the generally applicable revenue-based nominal amount standard at 8 percent of the total combined revenues from the payer of providers and suppliers in participating APM Entities for QP Performance Periods 2019 through 2024. This change is consistent with the proposed amendment to our regulation to maintain the generally applicable revenue-based nominal standard at 8 percent for Advanced APMs during the same timeframe.
We solicited comment on this proposal.
The following is a summary of the public comments received in response to our request for comment and our responses:
After considering public comments, we are finalizing our proposal to revise § 414.1420(d)(3)(i) to maintain the generally applicable revenue-based nominal amount standard at 8 percent of the total combined revenues from the payer of providers and suppliers in participating APM Entities for QP Performance Periods 2021 through 2024.
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).
In the CY 2018 Quality Payment Program final rule, we codified at § 414.1445 the Payer Initiated Other Payer Advanced APM Determination Process and the Eligible Clinician Initiated Other Payer Advanced APM Determination Process pertaining to the determination of Other Payer Advanced APMs, as well as specifying the information required for Other Payer Advanced APM determinations (82 FR 53814 through 53873).
In the CY 2018 Quality Payment Program final rule, we finalized that Other Payer Advanced APM determinations made in response to requests submitted either through the Payer Initiated Other Payer Advanced APM Determination Process (Payer Initiated Process) or the Eligible Clinician Initiated Other Payer
After consideration of this feedback, we proposed to maintain the annual submission process with the modifications outlined below for both the Payer Initiated Process and the Eligible Clinician Initiated Process. We proposed that beginning with the 2019 and 2020 submission periods for Other Payer Advanced APM determinations for performance year 2020, after the first year that a payer, APM Entity, or eligible clinician (which we refer to as the “requester” in the remainder of this discussion) submits a multi-year payment arrangement that we determine to be an Other Payer Advanced APM for that year, the requester would need to submit information only on changes to the payment arrangement that are relevant to the Other Payer Advanced APM criteria for each successive year for the remaining duration of the payment arrangement. In the initial submission, the requester would certify as usual that the information provided about the payment arrangement using the Payer Initiated Process or Eligible Clinician Initiated Process, as applicable, is true, accurate, and complete; would authorize CMS to verify the information; and would certify that they would submit revised information in the event of a material change to the payment arrangement. For multi-year payment arrangements, we proposed to require as part of the submission that the certifying official for the requester must agree to review the submission at least once annually, to assess whether there have been any changes to the information since it was submitted, and to submit updated information notifying us of any changes to the payment arrangement that would be relevant to the Other Payer Advanced APM criteria, and thus, to our determination of the arrangement to be an Other Payer Advanced APM, for each successive year of the arrangement. Absent the submission by the requester of updated information to reflect changes to the payment arrangement, we would continue to apply the original Other Payer Advanced APM determination for each successive year through the earlier of the end of that multi-year payment arrangement or 5 years.
We solicited comment on this proposal.
The following is a summary of the public comments received in response to our request for comment and our responses:
After considering public comments, we are finalizing our proposal to maintain the annual submission process with the modifications outlined above for both the Payer Initiated Process and the Eligible Clinician Initiated Process.
For multi-year payment arrangements, we proposed to require as part of the submission that the certifying official for the requester must agree to review the submission at least once annually, to assess whether there have been any changes to the information since it was submitted, and to submit updated information notifying us of any changes to the payment arrangement that would be relevant to the Other Payer Advanced APM criteria, and thus, to our determination of the arrangement to be an Other Payer Advanced APM, for each successive year of the arrangement. Absent the submission by the requester of updated information to reflect changes to the payment arrangement, we would continue to apply the original Other Payer Advanced APM determination for each successive year through the earlier of the end of that multi-year payment arrangement or 5 years.
We solicited comment on this proposal.
The following is a summary of the public comments received in response to our request for comment and our responses:
After considering public comments, we are finalizing our proposal to require as part of the submission that the certifying official for the requester must agree to review the submission at least once annually, to assess whether there have been any changes to the information since it was submitted, and to submit updated information notifying us of any changes to the payment arrangement that would be relevant to the Other Payer Advanced APM criteria, and thus, to our determination of the arrangement to be an Other Payer Advanced APM, for each successive year of the arrangement. Absent the submission by the requester of updated information to reflect changes to the payment arrangement, we will continue to apply the original Other Payer Advanced APM determination for each successive year through the earlier of the end of that multi-year payment arrangement or 5 years.
In the CY 2018 Quality Payment Program final rule, we finalized that we will allow certain other payers, including payers with payment arrangements authorized under Title XIX, Medicare Health Plan payment arrangements (Medicare Advantage plans, section 1876 cost plans PACE organization operated under section 1894 of the Act, and similar plans, other than an APM under section 1833(z)(3)(C) of the Act, that provide Medicare benefits under demonstration or waiver authority), and payers with payment arrangements aligned with a CMS Multi-Payer Model to use the Payer Initiated Process 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 (82 FR 53854). We codified this policy at § 414.1445(b)(1).
We also finalized that the Remaining Other Payers, including commercial and other private payers, may request that
In the CY 2019 PFS proposed rule, we proposed details regarding the Payer Initiated Process for the Remaining Other Payers that were not among those other payers permitted to use the Payer Initiated Process to submit their arrangements for Other Payer Advanced APM Determinations in 2018 (Remaining Other Payers). To the extent possible, we are aligning the Payer Initiated Process for Remaining Other Payers with the previously finalized Payer Initiated Process for Medicaid, Medicare Health Plans, and CMS Multi-Payer Models.
In the CY 2018 Quality Payment Program final rule, we finalized that the Payer Initiated Process will be voluntary for all payers (82 FR 53855). We note that the Payer Initiated Process will be similarly voluntary for payers that were permitted to submit payment arrangements in 2018 and for Remaining Other Payers starting in 2019.
We solicited comment on this proposal.
The following is a summary of the public comments received in response to our request for comment and our responses:
After considering public comments, we are finalizing our proposal that Remaining Other Payers will use the Payer Initiated Submission Form to request that CMS make an Other Payer Advanced APM determination.
We proposed that Remaining Other Payers may submit requests for review of multiple other payer arrangements through the Payer Initiated Process, though we would make separate determinations as to each other payer arrangement and a payer would be required to use a separate Payer Initiated Submission Form for each other payer arrangement. Remaining Other Payers may submit other payer arrangements with different tracks within that arrangement as one request along with information specific to each track.
We solicited comment on this proposal.
We did not receive any comment in response to this proposal.
We are finalizing our proposal that Remaining Other Payers may submit requests for review of multiple other payer arrangements through the Payer Initiated Process, though we would make separate determinations as to each other payer arrangement and a payer would be required to use a separate Payer Initiated Submission Form for each other payer arrangement.
We solicited comment on this proposal.
The following is a summary of the public comments received in response to our request for comment and our responses:
After considering public comments, we are finalizing our proposal that the Payer Initiated Process for use by Remaining Other Payers to request Other Payer Advanced APM determinations would open on January 1.
The finalized timeline for the Payer Initiated Process for Remaining Other Payers as well as the previously finalized timeline for the Payer Initiated Process for Medicaid and Medicare Health Plans, is summarized in Table 59 alongside the final timeline for the Eligible Clinician Initiated Process.
We solicited comment on this proposal.
We did not receive any comments in response to this proposal.
We are finalizing our proposal that if we find that the Remaining Other Payer has submitted incomplete or inadequate information, we would inform the payer and allow them to submit additional information no later than 15 business days from the date we inform the payer of the need for additional information.
In the CY 2018 Quality Payment Program final rule, we finalized that beginning for the first QP Performance Period under the All-Payer Combination Option, payers with a payment arrangement aligned with a CMS Multi-Payer Model may request that we determine whether that aligned payment arrangement is an Other Payer Advanced APM.
In the CY 2019 PFS proposed rule, we proposed to eliminate the Payer Initiated Process and submission form that are specifically for CMS Multi-Payer Models. We believe that payers aligned with CMS Multi-Payer Models can submit their arrangements through the Payer Initiated Process for
We solicited comment on this proposal.
We did not receive any comment in response to this proposal.
We are finalizing our proposal to eliminate the Payer Initiated Process and submission form that are specifically for CMS Multi-Payer Models.
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 77459).
In the CY 2017 Quality Payment Program final rule, we finalized that we will calculate Threshold Scores under the Medicare Option through both the payment amount and the patient count methods, compare each Threshold Score to the relevant QP and Partial QP Thresholds, and use the most advantageous scores to make QP determinations (81 FR 77457). We finalized the same approach for the All-Payer Combination Option wherein we will use the most advantageous method for QP determinations with the data that has been provided (81 FR 77475).
In the CY 2018 Quality Payment Program final rule, we finalized that an eligible clinician may request a QP determination at the eligible clinician level, and that an APM Entity may request a QP determination at the APM Entity Level (82 FR 53880 through 53881). In the event that we receive a request for QP determination from an individual eligible clinician and also separately 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 (82 FR 53881).
We proposed to add a third alternative to allow requests for QP determinations at the TIN level in instances where all clinicians who have reassigned billing rights under the TIN participate in a single (meaning the same) APM Entity. Therefore, this option would be available to all TINs participating in Full TIN APMs, such as the Medicare Shared Savings Program. It would also be available to any other TIN for which all clinicians who have reassigned their billing rights to the TIN are participating in the same APM Entity.
We solicited comment on this proposal.
The following is a summary of the public comments received in response to our request for comment and our responses:
After considering public comments, we are finalizing our proposal to add a third alternative to allow requests for QP determinations at the TIN level in instances where all clinicians who have reassigned billing rights under the TIN participate in a single APM Entity.
We proposed that, similar to our existing policies for individual and APM Entity requests for QP determinations under the All-Payer Combination Option, we would assess QP status based on the most advantageous result for each individual eligible clinician. That is, if we receive any combination of QP determination requests (at the TIN-level, APM Entity level, or individual level) we will make QP assessments at all requested levels and determine QP status on the basis of the QP assessment that is most advantageous to the eligible clinician.
We solicited comment on this proposal.
The following is a summary of the public comments received in response to our request for comment and our responses:
After considering public comments, we are finalizing our proposal to assess QP status based on the most advantageous result for each individual eligible clinician.
In the CY 2018 Quality Payment Program final rule, we finalized that when we make QP determinations at the individual eligible clinician level, we would use the individual eligible clinician payment amounts and patient counts for the Medicare calculations in the All-Payer Combination Option. When we make QP determinations at the APM Entity level, we will use APM Entity level payment amounts and patient counts for the Medicare calculations in QP determinations under the All-Payer Combination Option. Eligible clinicians assessed at the individual eligible clinician level under the Medicare Option at § 414.1425(b)(2) will be assessed at the individual eligible clinician level only under the All-Payer Combination Option. We codified these policies at § 414.1440(d)(2) (82 FR 53881).
We noted in the CY 2019 PFS proposed rule that some may have read our regulation at § 414.1440(d)(2) to suggest that consistency is required across the two thresholds requiring eligible clinicians or APM Entities to meet the minimum Medicare threshold needed to qualify for the All-Payer Combination Option and the All-Payer threshold using the same method—either payment amounts or patient counts. Although we did not directly address this specific question in our current regulation or in prior rulemaking, we are clarifying that eligible clinicians or APM Entities can meet the minimum Medicare threshold for the All-Payer Combination option using one method (whichever is most favorable), and the All-Payer threshold for the All-Payer Combination Option using either the same, or the other method. All data submitted to us for Other Payer Advanced APM determinations and, when applicable, QP determinations using the All-Payer Combination Option will be considered and evaluated; and eligible clinicians (or APM Entities or TINs, as appropriate) may submit all data relating to both the payment amount and patient count methods. To avoid any potential ambiguity for the future, we proposed a change to § 414.1440(d)
We solicited comment on this proposal.
The following is a summary of the public comments received in response to our request for comment and our responses:
After considering public comments, we are finalizing our proposal with the correction noted above, that we are amending the text in our regulation at § 414.1440(d)(1) to expressly allow eligible clinicians or APM Entities to meet the minimum Medicare threshold using the most favorable of the payment amount or patient count method, and then to meet the All-Payer threshold using either the same method or the other method.
In the CY 2018 Quality Payment Program final 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 (82 FR 53881-53882). In situations where eligible clinicians are assessed under the Medicare Option as an APM Entity group, and receive a Medicare Threshold Score at the APM Entity group level, we believe that the Medicare portion of their All-Payer calculation under the All-Payer Combination Option should not be lower than the Medicare Threshold Score that they received by participating in an APM Entity group.
To accomplish this outcome, we finalized a modified weighting methodology. We finalized that when the eligible clinician's Medicare Threshold Score calculated at the individual level would be lower than the Medicare Threshold Score calculated at the APM Entity group level, we would apply a weighting methodology to calculate the Threshold Score for the eligible clinician. This methodology allows 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 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:
In the CY 2019 PFS proposed rule, we proposed to extend the same weighting methodology to TIN level Medicare Threshold Scores in situations where a TIN is assessed under the Medicare Option as part of an APM Entity group, and receives a Medicare Threshold Score at the APM Entity group level. In this scenario, we believe that the Medicare portion of the TIN's All-Payer Combination Option Threshold Score should not be lower than the Medicare Threshold Score that they received by participating in an APM Entity group (82 FR 53881-53882). We note this extension of the weighting methodology would only apply to a TIN when that TIN represents a subset of the eligible clinicians in the APM Entity, because when the TIN and the APM Entity are the same there is no need for this weighted methodology. We would multiply the TIN's APM Entity group Medicare Threshold Score by the total Medicare payments or patients for that TIN as follows:
We proposed to calculate the TIN's Threshold Scores both on its own and with this weighted methodology, and then use the most advantageous score when making a QP determination. We believe that, as it does for QP determinations made at the APM Entity level, this approach promotes consistency between the Medicare Option and the All-Payer Combination Option to the extent possible. Additionally, the proposed application of this weighting approach in the case of a TIN level QP determination would be consistent with our established policy.
We solicited comment on this proposal.
The following is a summary of the public comments received in response to our request for comment and our responses:
After considering public comments, we are finalizing our proposal to extend the same weighting methodology to TIN level Medicare Threshold Scores in situations where a TIN is assessed under the Medicare Option as part of an APM Entity group, and receives a Medicare Threshold Score at the APM Entity group level.
In this section, we are finalizing the following policies:
• We are finalizing our proposal to change the CEHRT use criterion so that in order to qualify as an Other Payer Advanced APM as of January 1, 2020, the percentage of eligible clinicians participating in the other payer arrangement who are using CEHRT must be 75 percent.
• We are finalizing our proposal to allow payers and eligible clinicians to submit evidence as part of their request for an Other Payer Advanced APM determination that CEHRT is used by the requisite percentage of eligible clinicians participating in the payment arrangement (50 percent for 2019, and 75 percent for 2020 and beyond) to document and communicate clinical care, whether or not CEHRT use is explicitly required under the terms of the payment arrangement. We codifying this change at § 414.1420(b).
• We are finalizing the following clarification to § 414.1420(c)(2), effective January 1, 2020, to provide that at least one of the quality measures used in the payment arrangement in paragraph (c)(1) of this regulation must be:
++ Finalized on the MIPS final list of measures, as described in § 414.1330;
++ Endorsed by a consensus-based entity; or
++ Determined by CMS to be evidenced-based, reliable, and valid.
• We are finalizing our proposal to revise § 414.1420(c)(3) to require that, effective January 1, 2020, unless there is no applicable outcome measure on the MIPS quality measure list, an Other Payer Advanced APM must use an outcome measure, that meets the proposed criteria in paragraph (c)(2) of this regulation.
• We are also finalizing our proposal at § 414.1420(c)(3)(i) that, for payment arrangements determined to be Other Payer Advanced APMs for the 2019 performance year which did not include an outcome measure that is evidence-based, reliable, and valid, that are resubmitted for an Other Payer Advanced APM determination for the 2020 performance year (whether for a single year, or for a multi-year determination as proposed in section III.I.4.g.(3)(b) of this final rule), we would continue to apply the current regulation for purposes of those determinations. This revision also applies to payment arrangements in existence prior to the 2020 performance year that are submitted for determination to be Other Payer Advanced APMs for the 2020 performance year and later.
• We are finalizing details regarding the Payer Initiated Process for Remaining Other Payers. To the extent possible, we are aligning the Payer Initiated Process for Remaining Other Payers with the previously finalized Payer Initiated Process for Medicaid, Medicare Health Plans, and CMS Multi-Payer Models.
• We are finalizing our proposal to eliminate the Payer Initiated Process that is specifically for CMS Multi-Payer Models. We believe that payers aligned with CMS Multi-Payer Models can submit their arrangements through the Payer Initiated Process for Remaining Other Payers that we are finalizing as described in section III.I.4.g.(3)(c) of this final rule, or through the Medicaid or Medicare Health Plan payment arrangement submission processes.
• We are finalizing our proposal to add a third alternative to allow requests for QP determinations at the TIN level in instances where all clinicians who reassigned billing rights under the TIN participate in a single APM Entity. We are finalizing this proposal to revise § 414.1440(d), by adding this third alternative to allow QP determinations at the TIN level in instances where all clinicians who have reassigned billing under the TIN participate in a single APM Entity, as well as to assess QP status at the most advantageous level for each eligible clinician.
• We also are finalizing our clarification that, in making QP determinations using the All-Payer Combination Option, eligible clinicians may meet the minimum Medicare threshold using one method, and the All-Payer threshold using the same or a different method. We are finalizing our proposal with a correction to codify this clarification by amending § 414.1440(d)(1).
• We are finalizing our proposal to extend the same weighting methodology to TIN level Medicare Threshold Scores in situations where a TIN is assessed under the Medicare Option as part of an APM Entity group, and receives a Medicare Threshold Score at the APM Entity group level.
We proposed certain technical revisions to our regulations in order to correct several technical errors and to reconcile the text of several of our regulations with the final policies we adopted through notice and comment rulemaking.
We proposed a technical correction to § 414.1415(b)(1) of our regulations to specify that an Advanced APM must require quality measure performance as a factor when determining payment to participants for covered professional services under the terms of the APM (83 FR 36005). The addition of the word “quality” better aligns with section 1833(z)(3)(D) of the Act and with the policy that was finalized in the CY 2017 Quality Payment Program final rule (81 FR 77406), and corrects a clerical error we made in the course of revising the text of § 414.1415(b)(1) for inclusion in the CY 2017 QPP final rule. This proposed revision would not change our current policy for this Advanced APM criterion.
We solicited comment on this proposal.
We did not receive any comments in response to this proposal.
We are finalizing the technical correction to § 414.1415(b)(1) to specify that an Advanced APM must require quality measure performance as a factor when determining payment to participants for covered professional services under the terms of the APM.
We also proposed technical corrections to § 414.1420(d)(3)(ii)(B) (83 FR 36005). These changes align with the generally applicable nominal amount standard for Other Payer Advanced APMs that was finalized in the CY 2017 Quality Payment Program final rule, and the change to the generally applicable nominal amount standard in the CY 2018 Quality Payment Program final rule where we established a revenue-based nominal amount standard as part of the Other Payer Advanced APM
We solicited comment on this proposal.
The following is a summary of the public comments received in response to our request for comment and our responses:
After considering public comments, we are finalizing this technical correction by removing the Other Payer Advanced APM Criteria, Financial Risk, Generally Applicable Nominal Amount Standard provision at § 414.1420(d)(3)(ii)(B) and consolidating § 414.1420(d)(3)(ii)(A) into § 414.1420(d)(3)(ii).
In the CY 2017 Quality Payment Program final rule, we finalized a capitation standard for the financial risk criterion under the Advanced APM Criteria and the Other Payer Advanced APM Criteria, respectively. We finalized that full capitation arrangements would meet the Advanced APM financial risk criterion and Other Payer Advanced APM financial risk criterion, and would not separately need to meet the generally applicable financial risk standard and generally applicable nominal amount standard in order to satisfy the financial risk criterion for Advanced APMs and Other Payer Advanced APMs (81 FR 77431; 77472). We proposed to clarify the application of the capitation standard by revising § 414.1415(c) and § 414.1420(d) to refer to the full capitation exception that is expressed in paragraphs (c)(6) and (d)(7), respectively (83 FR 36006).
We solicited comment on this proposal.
We did not receive any comments in response to this proposal.
We are finalizing our proposal to clarify the application of the capitation standard by revising § 414.1415(c) and § 414.1420(d) to refer to the full capitation exception that is expressed in paragraphs (c)(6) and (d)(7), respectively.
In finalizing §§ 414.1415(c)(6) and 414.1420(d)(7), we specified that a capitation arrangement means a payment arrangement in which a per capita or otherwise predetermined payment is made under the APM for all items and services for which payment is made through the APM furnished to a population of beneficiaries, and no settlement is performed to reconcile or share losses incurred or savings earned by the APM Entity. This language does not completely reflect our definition of capitation risk arrangements as discussed in the preamble at 81 FR 77430 where we state that, “capitation risk arrangements, as defined here, involve full risk for the population of beneficiaries covered by the arrangement, recognizing that it might require no services whatsoever or could require exponentially more services than were expected in calculating the capitation rate. . . . [a] capitation risk arrangement adheres to the idea of a global budget for all items and services to a population of beneficiaries during a fixed period of time.” Therefore, we proposed to revise these regulations to align the Advanced APM Criteria, Financial Risk, Capitation provision at § 414.1415(c)(6), and the Other Payer Advanced APM Criteria, Financial Risk, Capitation provision at § 414.1420(d)(7) with the definition of capitation risk arrangements that we expressed in the preamble of the CY 2017 Quality Payment Program final rule at 81 FR 77430-77431 (83 FR 36006).
We solicited comment on this proposal.
We did not receive any comments in response to this proposal.
We are finalizing our proposal to revise the Advanced APM Criteria, Financial Risk, Capitation provision at § 414.1415(c)(6), and the Other Payer Advanced APM Criteria, Financial Risk, Capitation provision at § 414.1420(d)(7) to align with the definition of capitation risk arrangements that we expressed in the preamble of the CY 2017 Quality Payment Program final rule at 81 FR 77430-77431.
We also proposed a technical correction to remove the “; or” and replace it with a “.” at § 414.1420(d)(3)(i) because the paragraph that follows that section does not specify a standard that is necessarily an alternative to the standard under § 414.1420(d)(3)(i), but rather expresses a standard that is independent of the standard under § 414.1420(d)(3)(i) (83 FR 36006). As indicated in the CY 2018 Quality Payment Program final rule at 82 FR 53849-53850, where we established a revenue-based nominal amount standard for Other Payer Advanced APMs, in order to meet the generally applicable nominal amount standard under the Other Payer Advanced APM criteria, the total amount that an APM Entity potentially owes the payer or foregoes under a payment arrangement must be 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 under the payment arrangement; or, 3 percent of the expected expenditures for which an APM Entity is responsible under the payment arrangement.
We solicited comment on this proposal.
We did not receive any comments in response to this proposal.
We are finalizing our proposal to remove the “; or” and replace it with a “.” at § 414.1420(d)(3)(i) because the paragraph that follows that section does not specify a standard that is necessarily an alternative to the standard under § 414.1420(d)(3)(i), but rather expresses a standard that is independent of the standard under § 414.1420(d)(3)(i).
We also proposed to revise § 414.1440(d)(3) to correct a typographical error by replacing the “are” with “is” in the third clause of the second sentence (83 FR 36006).
We solicited comment on this proposal.
We did not receive any comments in response to this proposal.
We are finalizing our proposal to revise § 414.1440(d)(3) to correct a typographical error by replacing the “are” with “is” in the third clause of the second sentence.
We are finalizing these technical corrections to our regulations at §§ 414.1415(b)(1), 414.1420(d)(3)(ii),
This section addressed two requests for information (RFI).
In the CY 2019 PFS proposed rule (83 FR 35704 through 36368), we included an RFI related to promoting interoperability and electronic health care information exchange (83 FR 36006 through 36009). We received approximately 79 timely pieces of correspondence on this RFI. We appreciate the input provided by commenters.
In the CY 2019 PFS proposed rule (83 FR 35704 through 36368), we included an RFI related to price transparency and improving beneficiary access to provider and supplier charge information (83 FR 36009 through 36010). We received approximately 94 timely pieces of correspondence on this RFI. We appreciate the input provided by commenters.
On March 23, 2010, the Patient Protection and Affordable Care Act (Pub. L. 111-148) was enacted, followed by enactment of the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) on March 30, 2010, which amended certain provisions of the Patient Protection and Affordable Care Act (hereinafter collectively referred to as “the Affordable Care Act”). Section 3022 of the Affordable Care Act amended Title XVIII of the Act (42 U.S.C. 1395
The final rule establishing the Shared Savings Program appeared in the November 2, 2011
Through subsequent rulemaking, we have revisited and amended Shared Savings Program policies in light of the additional experience we gained during the initial years of program implementation as well as from testing through the Pioneer ACO Model, the Next Generation ACO Model and other initiatives conducted by the Center for Medicare and Medicaid Innovation (Innovation Center) under section 1115A of the Act. A major update to the program rules appeared in the June 9, 2015
Policies applicable to Shared Savings Program ACOs have continued to evolve based on changes in the law. The Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L. 114-10) (MACRA) established the Quality Payment Program. In the CY 2017 Quality Payment Program final rule with comment period (81 FR 77008), CMS established regulations for the Merit-Based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (APMs) and related policies applicable to eligible clinicians who participate in the Shared Savings Program.
The requirements for assignment of Medicare FFS beneficiaries to ACOs participating under the program were amended by the 21st Century Cures Act (Pub. L. 114-255). Accordingly, we revised the program's regulations in the CY 2018 PFS final rule to reflect these new requirements.
On February 9, 2018, the Bipartisan Budget Act of 2018 was enacted (Pub. L. 115-123), amending section 1899 of the Act to provide for the following: Expanded use of telehealth services by physicians or practitioners participating in an applicable ACO to a prospectively assigned beneficiary, greater flexibility in the assignment of Medicare FFS beneficiaries to ACOs by allowing ACOs in tracks under retrospective beneficiary assignment a choice of prospective assignment for the agreement period, permitting Medicare FFS beneficiaries to voluntarily identify an ACO professional as their primary care provider and mandating that any such voluntary identification will supersede claims-based assignment, and allowing ACOs under certain two-sided models to establish CMS-approved beneficiary incentive programs.
On August 17, 2018 a proposed rule, titled “Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations—Pathways to Success” (hereinafter referred to as the “August 2018 proposed rule”), appeared in the
In this section of the final rule, we discuss the proposal, the comments received, and the final action that we are taking for the following proposals in the August 2018 proposed rule:
• A voluntary 6-month extension for existing ACOs whose participation agreements expire on December 31, 2018, and the methodology for determining financial and quality performance for this 6-month performance year from January 1, 2019 through June 30, 2019. We believe it is necessary to finalize the extension before these ACOs' participation agreements expire on December 31, 2018, so that they can continue their participation in the program without interruption. It is also necessary to finalize the methodology for determining ACO quality and financial performance for the extension period in advance of the 6-month performance year beginning on January 1, 2019.
• Implementation of the provisions of section 50331 of the Bipartisan Budget Act of 2018 on voluntary alignment. The Bipartisan Budget Act was enacted earlier this year, and we believe it is most consistent with the requirements of the statute to revise our voluntary alignment policies effective with assignment for performance years starting on January 1, 2019, to reflect the additional flexibility given to beneficiaries in selecting their primary care provider.
• A modification to the definition of primary care services used in assigning beneficiaries to ACOs to reflect recent code changes. Including these codes in the definition of primary care services will improve the accuracy of the assignment methodology and help to ensure that beneficiaries are assigned to the ACO that is responsible for coordinating their overall care.
• Relief for ACOs and their clinicians impacted by extreme and uncontrollable circumstances in performance year 2018 and subsequent years. We believe it is necessary to finalize the changes to the extreme and uncontrollable circumstances policies for the Shared Savings Program as quickly as possible to ensure that relief is available for ACOs affected by the recent hurricanes in North Carolina and Florida and other disasters during 2018.
• Revisions to program requirements to further promote interoperability among ACO providers and suppliers. We believe it is necessary to finalize changes to our CEHRT use requirements to align with the Quality Payment Program.
We are also making technical changes to update the authority citation for 42 CFR part 425 to conform with OFR requirements.
The changes will be effective on December 31, 2018. Applicability or implementation dates may vary, depending on the policy, and the timing specified in this final rule. By indicating that a provision is applicable to a performance year (PY) or agreement period, activities related to implementation of the policy may precede the start of the performance year or agreement period.
In this final rule, we are addressing a subset of the proposals in the August 2018 proposed rule for participation options for agreement periods beginning in 2019. In the August 2018 proposed rule, we stated that we would forgo an application cycle for a January 1, 2019 agreement start date and proposed to allow for a July 1, 2019 agreement start date. We proposed an approach for determining financial and quality performance for two 6-month performance years during 2019, with the first from January 1, 2019 through June 30, 2019, for ACOs with participation agreements expiring on December 31, 2018, that elect a voluntary 6-month extension, and the second from July 1, 2019 through December 31, 2019, for ACOs entering a new agreement period beginning July 1, 2019. We also proposed an approach for determining financial and quality performance for the performance period from January 1, 2019 through June 30, 2019 for an ACO starting a 12-month performance year on January 1, 2019, that terminates its participation agreement with an effective date of termination of June 30, 2019, and enters a new agreement period beginning on July 1, 2019, referred to as “early renewals.”
In this final rule, we are addressing our proposals to allow for a voluntary 6-month extension for ACOs whose agreement periods expire on December 31, 2018, and to establish a methodology for determining financial and quality performance for the 6-month performance year from January 1, 2019 through June 30, 2019. These proposals were necessary to prevent some ACOs from experiencing an involuntary gap in participation as a result of our decision to forgo an application cycle in 2018 for a January 1, 2019 agreement start date. Therefore, in this section of the final rule, we summarize and respond to comments and address final actions specific to our proposals regarding the 6-month extension and the methodology for determining financial and quality performance for the 6-month performance year from January 1, 2019 through June 30, 2019. As we describe in this section, some modifications to our proposals are necessary because of the limited scope of this final rule.
In a forthcoming final rule, we anticipate summarizing and responding to public comments on the other proposed policies related to determining financial and quality performance in 2019 for the following: (1) The performance period from January 1, 2019 through June 30, 2019, for ACOs starting a 12-month performance year on January 1, 2019, that terminate their participation agreement with an effective date of termination of June 30, 2019, and enter a new agreement period beginning on July 1, 2019; and (2) the 6-month performance year from July 1, 2019 through December 31, 2019, for ACOs entering an agreement period beginning on July 1, 2019.
In section II.A.7. of the August 2018 proposed rule (83 FR 41847), we explained that we were forgoing the application cycle that otherwise would take place during CY 2018 for a January 1, 2019 start date for new Shared Savings Program participation agreements, initial use of the Skilled Nursing Facility (SNF) 3-day rule waiver, and entry into the Track1+ Model, and we proposed to offer a July 1, 2019 start date as the initial opportunity for ACOs to enter an agreement period under the proposed BASIC track or ENHANCED track, which would be offered under the proposed redesign of the program's participation options. We proposed the July 1, 2019 start date as a one-time opportunity, and thereafter we would resume our typical process of offering an annual application cycle that allows for review and approval of applications in advance of a January 1 agreement start date.
We proposed that ACOs that entered a first or second agreement period with a start date of January 1, 2016 could elect to extend their agreement period for an optional fourth performance year, defined as the 6-month period from January 1, 2019 through June 30, 2019. This election to extend the agreement period would be voluntary and an ACO could choose not to extend its agreement period, in which case it would conclude its participation in the program with the expiration of its current agreement period on December 31, 2018.
We proposed that the ACO's voluntary election to extend its agreement period must be made in the form and manner and according to the timeframe established by CMS, and that an ACO executive who has the authority to legally bind the ACO must certify the election. We explained our expectation that this election process, if finalized, would begin in 2018 following the publication of the final rule, as part of the annual certification process in advance of 2019 (described in section II.A.7.c.(2) of the August 2018 proposed rule (83 FR 41855)). We noted that this optional 6-month agreement period extension would be a one-time exception for ACOs with agreements expiring on December 31, 2018, and would not be available to other ACOs that are currently participating in a 3-year agreement in the program, or to future program entrants.
In the August 2018 proposed rule, we noted that under the existing provision at § 425.210, the ACO must provide a copy of its participation agreement with CMS to all ACO participants, ACO providers/suppliers, and other individuals and entities involved in ACO governance. Further, all contracts or arrangements between or among the ACO, ACO participants, ACO providers/suppliers, and other individuals or entities performing functions or services related to ACO activities must require compliance with the requirements and conditions of the program's regulations, including, but not limited to, those specified in the participation agreement with CMS. We proposed that an ACO that elects to extend its participation agreement by 6 months must notify its ACO participants, ACO providers/suppliers and other individuals or entities performing functions or services related to ACO activities of this continuation of participation and must require their continued compliance with the program's requirements for the 6-month performance year from January 1, 2019 through June 30, 2019.
As discussed in section II.A.2. of the August 2018 proposed rule (83 FR 41799 through 41800), we proposed modifications to the definition of “agreement period” in § 425.20 to broaden the definition to generally refer to the term of the participation agreement. We also proposed to add a provision at § 425.200(b)(2) specifying that the term of the participation agreement is 3 years and 6 months for an ACO that entered an agreement period starting on January 1, 2016, that elects to extend its agreement period until June 30, 2019, and this election is made in the form and manner and according to the timeframe established by CMS, and certified by an ACO executive who has the authority to legally bind the ACO (83 FR 41849). For consistency, we also proposed minor formatting changes to the existing provision at § 425.200(b)(2) and (b)(3) to italicize the header text.
We also proposed to revise the definition of “performance year” in § 425.20 to mean the 12-month period beginning on January 1 of each year during the agreement period, unless otherwise specified in § 425.200(c) or noted in the participation agreement. We also proposed revisions to § 425.200(c) to make necessary formatting changes and specify additional exceptions to the definition of performance year as a 12-month period. Specifically, we proposed to add a provision specifying that for an ACO that entered a first or second agreement period with a start date of January 1, 2016, and that elects to extend its agreement period by a 6-month period, the ACO's fourth performance year is the 6-month period between January 1, 2019, and June 30, 2019. Similarly, we proposed to add a provision specifying that for an ACO that entered an agreement period with a start date of July 1, 2019, the ACO's first performance year of the agreement period is defined as the 6-month period between July 1, 2019, and December 31, 2019 (83 FR 41849).
In light of the proposed modifications to § 425.200(c) to establish two 6-month performance years during CY 2019, we proposed revisions to the regulation at § 425.200(d), which reiterates an ACO's obligation to submit quality measures in the form and manner required by CMS for each performance year of the agreement period, to address the quality reporting requirements for ACOs participating in a 6-month performance year during CY 2019 (83 FR 41849).
We also considered forgoing an application cycle for a 2019 start date altogether and allowing ACOs to enter agreement periods under the proposed BASIC track and ENHANCED track for the first time beginning on January 1, 2020. This approach would allow ACOs additional time to consider the redesign of the program, make organizational and operational plans, and implement business and investment decisions, and would avoid the complexity of needing to determine performance based on 6-month performance years during CY 2019. However, we noted that our proposed approach of offering an application cycle during 2019 for an agreement period start date of July 1, 2019 would allow for a more rapid progression of ACOs to the redesigned participation options, starting in mid-2019. We further noted that, under this alternative, we would also want to offer ACOs that started a first or second agreement period on January 1, 2016, a means to continue their participation between the conclusion of their current 3-year agreement period (December 31, 2018) and the start of their next agreement period (January 1, 2020), should the ACO wish to continue in the program. We indicated that under that alternative, which would postpone the start date for the new participation options to January 1, 2020, we would allow ACOs that started a first or second agreement period on January 1, 2016, to elect a 12-month extension of their current agreement period to cover the duration of CY 2019.
We sought comment on these proposals and the related considerations, as well as the alternatives considered.
Some commenters explained that providing a 12-month extension option would give ACOs additional time to analyze program changes and prepare for the application process. One commenter expressed concern that a 6-month extension would provide a limited and inadequate amount of time for ACOs to consider participation options under a redesigned program, if a final rule establishing a July 1, 2019 start date is not issued until later in 2018. This commenter expressed the belief that this limited time to consider participation options in advance of a July 1, 2019 start date (if finalized) and general uncertainty about program policies would result in program attrition, due to ACOs and ACO participants electing not to continue in the program at the end of their current agreement. One commenter explained a 12-month extension would give ACOs additional time to evaluate whether they have the appropriate structure in place, implement processes to comply with new regulations, and make necessary changes to their ACO participant and ACO provider/supplier networks.
One commenter explained a 12-month extension would provide current ACOs with additional time and experience under their current agreement periods. Some commenters explained that providing a 12-month extension could avoid the complexity and increased burden on providers, practices, ACOs, and CMS that could potentially result from ACOs' participation in two, 6-month performance years in CY 2019. Other commenters raised concerns about making ACO participant list changes, and modifying agreements with their ACO participants, to allow for participation in two, 6-month performance years during CY 2019, with each performance year under a separate participation agreement: The first 6-month performance year under their current participation agreement (in an extension of their current agreement period); and the second 6-month performance year under a new participation agreement under one of the proposed redesigned participation options. Some commenters requesting a 12-month extension, or the choice between a 6-month or a 12-month extension, also raised concerns about the methodology for determining financial and quality performance for two, 6-month performance years during CY 2019. We summarize and respond to comments related to the methodology for determining performance for the6-month performance year from January 1, 2019 through December 31, 2019, and other program policies applicable to ACOs participating in this 6-month performance year, in sections V.B.1.b. and V.B.1.c. of this final rule.
We appreciate commenters' concerns about preparing to enter a new agreement period in light of uncertainty around the participation options that may be available. However, we note that, based on the proposals in the August 2018 proposed rule, ACOs whose agreement periods expire on December 31, 2018, that were interested in continuing their participation in the program have had an opportunity to identify their likely ACO participants for the proposed 6-month performance year from January 1, 2019 through June 30, 2019, and have received preliminary feedback from CMS for ACO participant list additions for the performance year beginning on January 1, 2019. Moreover, we believe these ACOs generally have begun preparing the necessary revisions to their agreements with ACO participants and ACO providers/suppliers and, if under a two-sided model to extend their repayment mechanism in anticipation of the possibility that we would finalize the proposed 6-month extension period. We believe these ACOs have also been weighing their participation options in advance of applying to renew for a subsequent agreement period, and will have additional time to make these determinations during the 6-month extension (if elected). In particular, ACOs reaching the conclusion of their second agreement period under Track 1, would have been weighing their participation options under two-sided models, given the current requirement that ACOs transition to a two-sided model by the start of their third agreement period. In fact, the 6-month extension allows ACOs completing their second agreement period in Track 1 to continue participation under their current agreement period and thereby receive additional time under a one-sided model that otherwise would not have been available to these ACOs under the program's current regulations.
We also believe it is important to ensure we retain the flexibility to allow ACOs to more rapidly transition, starting as early as July 1, 2019, to the proposed new participation options, should they be finalized, including the participation options that would be Advanced APMs that would allow eligible clinicians participating in the ACO to qualify for incentive payments
At this time, we believe the proposed 6-month extension for a 6-month performance year from January 1, 2019 through June 30, 2019, strikes an appropriate balance between these factors. To reduce the possibility for selective participation bias that could adversely affect the Trust Funds, we believe the same option for extending their current participation agreement should be made available to all eligible ACOs whose agreement periods expire December 31, 2018, as opposed to offering ACOs the option to choose between either a 6-month or a 12-month extension, or offering extensions of different lengths to ACOs based on their current participation track. For example, we believe that if we offered a choice regarding the length of the extension, only ACOs that would expect to benefit from being rebased under new program policies would elect a 6-month extension in order to allow the regional rebasing policies to apply sooner.
We also decline to adopt the commenter's suggestions that we finalize certain aspects of the proposed program redesign, such as the proposed modifications to the methodology for establishing, adjusting and updating an ACO's historical benchmark, and certain payment and program flexibilities for eligible ACOs participating under two-sided models, and apply these policies to a subset of the ACOs electing the voluntary extension. Continuing to apply the current benchmarking methodology during the optional fourth performance year maintains ACOs' existing historical benchmarks, allowing them to continue to build on their experience within their current agreement period and provides a more predictable and stable benchmark during the 6-month extension period. We also decline to allow only ACOs that are eligible for and elect the extension to have access to and make use of additional program and payment flexibilities (such as a SNF 3-day rule waiver, unless previously approved, or a beneficiary incentive program) as a way of allowing these organizations to gain experience with these policies in advance of their broader availability (if finalized) to eligible ACOs participating in the program. Our proposals to extend the availability of a SNF 3-day rule waiver and to give ACOs the opportunity to offer beneficiary incentive programs were developed in conjunction with our proposed changes to the participation options for ACOs participating in the Shared Savings Program. Therefore, we believe these proposals need to be considered together as part of a forthcoming final rule addressing our proposals for the overall redesign of the Shared Savings Program. Further, we believe it would be cumbersome to determine ACOs' eligibility for these flexibilities prior to the start of the performance year beginning January 1, 2019, particularly given the absence of a formal application cycle during CY 2018 during which ACOs could elect to apply for such opportunities.
ACOs electing the extension would need to extend all current ACO participant and/or SNF affiliate agreements on or before December 31, 2018, so that entities will continue to be ACO participants or SNF affiliates, as applicable, for the performance year beginning on January 1, 2019. Additionally, the ACO will need to execute ACO participant agreements with any new ACO participants to be added to its ACO participant list effective January 1, 2019. We also note that these ACOs would have been required to revise their ACO participant and SNF affiliate agreements, as applicable, if they had been renewing their participation agreements for a new agreement period beginning January 1, 2019. We also note that we now allow ACOs, ACO participants and SNF affiliates to digitally sign their agreements, which should help to reduce any burden associated with extending agreements. We believe that the timing of the issuance of this final rule will permit sufficient time for ACOs electing to extend their participation agreements to take the necessary steps to extend their ACO participant and SNF affiliate agreements, as applicable, before the start of the 6-month performance year beginning January 1, 2019.
In response to the commenter's concern that the extension would cause some ACO participants to be operating under different sets of expectations (depending on whether they started participating in the ACO prior to January 1, 2019 or after January 1, 2019), we note that for ACOs that elect the 6-month extension, the payment methodology under the ACO's current track would be applicable to determining the ACO's shared savings or shared losses, if applicable, for the 6-month performance year from January 1, 2019 through June 30, 2019. This is the same payment methodology that has applied to the ACO for the duration of its agreement period, beginning on January 1, 2016.
Further, we note that with the exception of the requirements specified at § 425.116, the ACO and its ACO participants have significant flexibility to determine the contractual terms that would apply with respect to all ACO participant agreements, including with respect to the use/distribution of shared savings (and payment of shared losses).
After considering the comments received, we are finalizing our proposal to allow ACOs that entered a first or second agreement period beginning on January 1, 2016, to voluntarily elect a 6-month extension of their current agreement period for a fourth performance year from January 1, 2019 through June 30, 2019. For the reasons discussed, we believe this extension is necessary in order to avoid an involuntary gap in participation and to provide ACOs with an opportunity to prepare for a more rapid transition to the proposed new participation options, including new Advanced APMs that would allow eligible clinicians
We received no comments on the proposed modifications to the definitions of “agreement period” and “performance year” in § 425.20 or to the regulation at § 425.200 to establish the 6-month extension and to make certain technical and conforming changes. We are finalizing as proposed the modifications to the definition of “agreement period” in § 425.20 to broaden the definition to generally refer to the term of the participation agreement and the revisions to § 425.200(a) to allow for agreement periods greater than 3 years. We are also finalizing our proposal to add a provision at § 425.200(b)(2) specifying that the term of the participation agreement is 3 years and 6 months for an ACO that entered an agreement period starting on January 1, 2016, that elects to extend its agreement period until June 30, 2019, and this election is made in the form and manner and according to the timeframe established by CMS, and certified by an ACO executive who has the authority to legally bind the ACO. For consistency, we are also finalizing as proposed the minor formatting changes to the existing provisions at § 425.200(b)(2) and (b)(3) to italicize the header text.
We are also finalizing as proposed the revision to the definition of “performance year” in § 425.20 to mean the 12-month period beginning on January 1 of each year during the agreement period, unless otherwise specified in § 425.200(c) or noted in the participation agreement. Therefore, we are also finalizing the proposed revisions to § 425.200(c) to make necessary formatting changes and specify an additional exception to the definition of performance year as a 12-month period. Specifically, we are finalizing our proposal to add a provision specifying that for an ACO that entered a first or second agreement period with a start date of January 1, 2016, and that elects to extend its agreement period by a 6-month period, the ACO's fourth performance year is the 6-month period between January 1, 2019, and June 30, 2019.
In light of the modifications we are finalizing to § 425.200(c) to establish a 6-month performance year during CY 2019, we are also finalizing the proposed revisions to the regulation at § 425.200(d), which reiterates an ACO's obligation to submit quality measures in the form and manner required by CMS for each performance year of the agreement period, to address the quality reporting requirements for ACOs participating in the 6-month performance year from January 1, 2019 through June 30, 2019. As described elsewhere in this final rule, ACOs electing the voluntary 6-month extension will be required to report quality measures for the 2019 reporting period, based on CY 2019, consistent with the existing quality reporting process and methodology.
Under our proposed approach to determining performance for the 6-month performance year from January 1, 2019 through June 30, 2019, after the conclusion of CY 2019, CMS would reconcile the financial and quality performance of ACOs that participated in the Shared Savings Program during 2019. For ACOs that extended their agreement period for the 6-month performance year from January 1, 2019 through June 30, 2019, CMS would first reconcile the ACO based on its performance during the entire 12-month calendar year, and then pro-rate the calendar year shared savings or shared losses to reflect the ACO's participation for only half of the calendar year. In the August 2018 proposed rule, we explained this approach would avoid a more burdensome interim payment process that could accompany an alternative proposal to instead implement, for example, an 18-month performance year. Consistent with the 18- and 21-month performance years offered for the first cohorts of Shared Savings Program ACOs, such a policy could require ACOs to establish a repayment mechanism that otherwise might not be required, create uncertainty over whether the ACO may ultimately need to repay CMS based on final results for the extended performance year, and delay ACOs seeing a return on their investment in program participation if eligible for shared savings.
We explained our belief that the proposed approach would allow continuity in program operations, including operations that occur on a calendar year basis. Specifically, the proposed approach would allow payment reconciliation to remain on a calendar year basis, which would be most consistent with the calendar year-based methodology for calculating benchmark expenditures, trend and update factors, risk adjustment, county expenditures and regional adjustments. We explained that deviating from a 12-month reconciliation calculation by using fewer than 12 months of performance year expenditures could interject actuarial biases relative to the benchmark expenditures, which are based on 12-month benchmark years. As a result, we believed the proposed approach of reconciling ACOs based on a 12-month period would protect the actuarial soundness of the financial reconciliation methodology. We also explained our belief that the alignment of the proposed approach with the standard methodology used to perform the same calculations for 12-month performance years that correspond to a calendar year would make it easier for ACOs and other program stakeholders to understand the proposed methodology.
As is the case with typical calendar year reconciliations in the Shared Savings Program, we anticipated results with respect to participation during CY 2019 would be made available to ACOs in summer 2020. We explained that this would allow those ACOs that are eligible to share in savings as a result of their participation in the program during CY 2019 to receive payment of shared savings following the conclusion of the calendar year consistent with the standard process and timing for annual payment reconciliation under the program.
In section II.A.7.b.2 of the August 2018 proposed rule (83 FR 41851 through 41853), we described in detail our proposed approach to determining an ACO's performance for the 6-month performance year from January 1, 2019 through June 30, 2019. We also proposed that these policies would apply to ACOs that begin a 12-month performance year on January 1, 2019, but elect to terminate their participation agreement with an effective date of termination of June 30, 2019, in order to enter a new agreement period starting on July 1, 2019 (early renewals). Our proposed policies addressed the following: (1) The ACO participant list that will be used to determine beneficiary assignment; (2) the approach to assigning beneficiaries; (3) the quality reporting period; (4) the benchmark year assignment methodology and the methodology for calculating, adjusting and updating the ACO's historical benchmark; and (5) the methodology for determining shared savings and shared losses. We proposed to specify these policies for reconciling the 6-month period from January 1, 2019 through June 30, 2019, in paragraph (b) of a new section of the regulations at § 425.609.
We proposed to use the ACO participant list for the performance year beginning January 1, 2019, to determine
To determine beneficiary assignment, we proposed to consider the allowed charges for primary care services furnished to the beneficiary during a 12-month assignment window, allowing for a 3 month claims run out. For the 6-month performance year from January 1, 2019 through June 30, 2019, we proposed to determine the assigned population using the following assignment windows:
• For ACOs under preliminary prospective assignment with retrospective reconciliation, the assignment window would be CY 2019.
• For ACOs under prospective assignment, Medicare FFS beneficiaries would be prospectively assigned to the ACO based on the beneficiary's use of primary care services in the most recent 12 months for which data are available. For example, in determining prospective beneficiary assignment for the January 1, 2019 through June 30, 2019 performance year we could use an assignment window from October 1, 2017 through September 30, 2018, to align with the off-set assignment window typically used to determine prospective assignment prior to the start of a calendar year performance year. Beneficiaries would remain prospectively assigned to the ACO at the end of CY 2019 unless they meet any of the exclusion criteria under § 425.401(b) during the calendar year.
As discussed in section II.A.7.c.(4) of the August 2018 proposed rule (83 FR 41856), to determine ACO performance during a 6-month performance year, we proposed to use the ACO's quality performance for the 2019 reporting period, and to calculate the ACO's quality performance score as provided in § 425.502. We also proposed to use a different quality measure sampling methodology depending on whether an ACO participates in both a 6-month performance year (or performance period) beginning on January 1, 2019, and a 6-month performance year beginning on July 1, 2019, or only participates in a 6-month performance year from January 1, 2019 through June 30, 2019. As described in section V.B.1.c.(4) of this final rule, given the limited scope of this final rule, at this time, we are finalizing only our proposal to use the ACO's latest certified participant list (the ACO participant list effective on January 1, 2019) to determine the quality reporting samples for the 2019 reporting period for ACOs that extend their prior participation agreement for the 6-month performance year from January 1, 2019 to June 30, 2019.
Consistent with current program policy, we proposed to determine assignment for the benchmark years based on the most recent certified ACO participant list for the ACO effective for the performance year beginning January 1, 2019. This would be the participant list the ACO certified prior to the start of its agreement period unless the ACO has made changes to its ACO participant list during its agreement period as provided in § 425.118(b). If the ACO has made subsequent changes to its ACO participant list, we would adjust its historical benchmark to reflect the most recent certified ACO participant list. See the Medicare Shared Savings Program, ACO Participant List and Participant Agreement Guidance (July 2018, version 5), available at
For the 6-month performance year from January 1, 2019 through June 30, 2019, we proposed to determine the benchmark and calculate performance year expenditures for assigned beneficiaries as though the performance year were the entire calendar year. The ACO's historical benchmark would be determined according to the methodology applicable to the ACO based on its agreement period in the program. We would apply the methodology for establishing, updating and adjusting the ACO's historical benchmark as specified in § 425.602 (for ACOs in a first agreement period) or § 425.603 (for ACOs in a second agreement period), except that data from CY 2019 would be used in place of data for the 6-month performance year in certain calculations, as follows:
• The benchmark would be adjusted for changes in severity and case mix between benchmark year 3 and CY 2019 using the methodology that accounts separately for newly and continuously assigned beneficiaries using prospective HCC risk scores and demographic factors as described under §§ 425.604(a)(1) through (3), 425.606(a)(1) through (3), and 425.610(a)(1) through (3).
• The benchmark would be updated to CY 2019 according to the methodology for using growth in national Medicare FFS expenditures for assignable beneficiaries described under §§ 425.602(b) (for ACOs in a first agreement period) and 425.603(b) (for ACOs in a second agreement period beginning January 1, 2016).
For determining financial performance during the 6-month performance year from January 1, 2019 through June 30, 2019, we would apply the methodology for determining shared savings and shared losses according to the approach specified for the ACO's track under the terms of the participation agreement that was in effect on January 1, 2019: § 425.604 (Track 1), § 425.606 (Track 2) or § 425.610 (Track 3) and, if applicable, the terms of the ACO's participation agreement for the Track 1+ Model authorized under section 1115A of the Act. (See discussion in section II.F. of the August 2018 proposed rule (83 FR 41912 through 41914) concerning applicability of proposed policies to Track 1+ Model ACOs.) However, some exceptions to the otherwise applicable methodology were needed because we proposed to calculate the expenditures for assigned beneficiaries over the full CY 2019 for purposes of determining shared savings and shared losses for the 6-month performance year from January 1, 2019 through June 30, 2019. We proposed to use the following steps to calculate shared savings and shared losses:
• Average per capita Medicare expenditures for Parts A and B services for CY 2019 would be calculated for the ACO's performance year assigned beneficiary population.
• We would compare these expenditures to the ACO's updated benchmark determined for the calendar year as previously described.
• We would apply the MSR and MLR (as applicable).
++ The ACO's assigned beneficiary population for the performance year starting on January 1, 2019, would be used to determine the MSR for Track 1 ACOs and the variable MSR/MLR for ACOs in a two-sided model that selected this option at the start of their agreement period. In the event a two-sided model ACO selected a fixed MSR/MLR at the start of its agreement period, and the ACO's performance year assigned population is below 5,000 beneficiaries, we proposed that the MSR/MLR would be determined based on the number of assigned beneficiaries as described in section II.A.6.b. of the August 2018 proposed rule (83 FR 41837 through 41839).
++ To qualify for shared savings, the ACO's average per capita Medicare expenditures for its performance year assigned beneficiaries during CY 2019 must be below its updated benchmark for the year by at least the MSR established for the ACO.
++ To be responsible for sharing losses with the Medicare program, the ACO's average per capita Medicare expenditures for its performance year assigned beneficiaries during CY 2019 must be above its updated benchmark for the year by at least the MLR established for the ACO.
• We would determine the shared savings amount if we determine the ACO met or exceeded the MSR, and if the ACO met the minimum quality performance standards established under § 425.502 as described in the August 2018 proposed rule and section V.B.1.c.(4) of this final rule, and otherwise maintained its eligibility to participate in the Shared Savings Program. We would determine the shared losses amount if we determine the ACO met or exceeded the MLR. To determine these amounts, we would do the following:
++ We would apply the final sharing rate or loss sharing rate to first dollar savings or losses.
++ For ACOs that generated savings that met or exceeded the MSR, we would multiply the difference between the updated benchmark expenditures and performance year assigned beneficiary expenditures by the applicable final sharing rate based on the ACO's track and its quality performance as calculated under § 425.502.
++ For ACOs that generated losses that met or exceeded the MLR, we would multiply the difference between the updated benchmark expenditures and performance year assigned beneficiary expenditures by the applicable shared loss rate based on the ACO's track and its quality performance as calculated under § 425.502 (for ACOs in tracks where the loss sharing rate is determined based on the ACO's quality performance).
• We would adjust the shared savings amount, if any, for sequestration by reducing by 2 percent and compare the sequestration-adjusted shared savings amount to the applicable performance payment limit based on the ACO's track.
• We would compare the shared losses amount, if any, to the applicable loss sharing limit based on the ACO's track.
• We would pro-rate any shared savings amount, as adjusted for sequestration and the performance payment limit, or any shared losses amount, as adjusted for the loss sharing limit, by multiplying by one half, which represents the fraction of the calendar year covered by the 6-month performance year. This pro-rated amount would be the final amount of shared savings that would be paid to the ACO for the 6-month performance year or the final amount of shared losses that would be owed by the ACO for the 6-month performance year.
We sought comment on these proposals.
In the August 2018 proposed rule (83 FR 41851), we explained our belief that the proposal to determine shared savings and shared losses for the 6-month performance year starting on January 1, 2019, using expenditures for the entire CY 2019 and then pro-rating these amounts to reflect the shorter performance year, requires the use of our authority under section 1899(i)(3) of the Act to use other payment models. Section 1899(d)(1)(B)(i) of the Act specifies that, in each year of the agreement period, an ACO is eligible to receive payment for shared savings only if the estimated average per capita Medicare expenditures under the ACO for Medicare FFS beneficiaries for Parts A and B services, adjusted for beneficiary characteristics, is at least the percent specified by the Secretary below the applicable benchmark under section 1899(d)(1)(B)(ii) of the Act. We explained our belief that the proposed approach to calculating the expenditures for assigned beneficiaries
In order to use our authority under section 1899(i)(3) of the Act to adopt an alternative payment methodology to calculate shared savings and shared losses for the proposed 6-month performance year from January 1, 2019 through June 30, 2019, we must determine that the alternative payment methodology will improve the quality and efficiency of items and services furnished to Medicare beneficiaries, without additional program expenditures. We explained our belief that the proposed approach of allowing ACOs that started a first or second agreement period on January 1, 2016, to extend their agreement period for a 6-month performance year and of allowing entry into the program's redesigned participation options beginning on July 1, 2019, if finalized, would support continued participation by current ACOs that must renew their agreements to continue participating in the program, while also resulting in more rapid progression to two-sided risk by ACOs within current agreement periods and ACOs entering the program for an initial agreement period. As discussed in the Regulatory Impact Analysis of the August 2018 proposed rule (83 FR 41915 through 41928), we explained our belief that this approach would continue to allow for lower growth in Medicare FFS expenditures based on projected participation trends. Therefore, we did not believe that the proposed methodology for determining shared savings or shared losses for ACOs in a 6-month performance year during 2019 would result in an increase in spending beyond the expenditures that would otherwise occur under the statutory payment methodology in section 1899(d) of the Act. Further, we noted that the proposed approach to measuring ACO quality performance for a 6-month performance year based on quality data reported for CY 2019 would maintain accountability for the quality of care ACOs provide to their assigned beneficiaries. Participating ACOs would also have an incentive to perform well on the quality measures in order to maximize the shared savings they may receive and minimize any shared losses they may be required to pay in tracks where the loss sharing rate is determined based on the ACO's quality performance. Therefore, we noted our expectation that this proposed approach to reconciling ACOs for a 6-month performance year during 2019 would continue to lead to improvement in the quality of care furnished to Medicare FFS beneficiaries.
As discussed in the Regulatory Impact Analysis section of this final rule (section VII.), we believe the approach to determining shared savings and shared losses for the 6-month performance year from January 1, 2019 through June 30, 2019, for ACOs that elect to voluntarily extend their agreement period meets the requirements for use of our authority under section 1899(i)(3) of the Act. The considerations we described in the August 2018 proposed rule were relevant in making this determination. Specifically, we do not believe that the methodology for determining shared savings or shared losses for ACOs in a 6-month performance year from January 1, 2019 through June 30, 2019, (as finalized in this section) will result in an increase in spending beyond the expenditures that would otherwise occur under the statutory payment methodology in section 1899(d) of the Act. Finalizing the voluntary 6-month extension for ACOs whose agreement periods expire on December 31, 2018, will support continued participation by these ACOs, and therefore, also allow for lower growth in Medicare FFS expenditures based on projected participation trends. Further, we believe the approach we are finalizing for reconciling ACOs for a 6-month performance year from January 1, 2019 through June 30, 2019, will lead to continued improvement in the quality of care furnished to Medicare FFS beneficiaries. As described in section V.B.1.c.(4) of this final rule, the approach to measuring ACO quality performance for the 6-month performance year from January 1, 2019 through June 30, 2019, based on quality data reported for CY 2019, will maintain accountability for the quality of care ACOs provide to their assigned beneficiaries. Participating ACOs will have an incentive to perform well on the quality measures in order to maximize the shared savings they may receive and minimize any shared losses they may be required to pay in two-sided risk tracks where the loss sharing rate is determined based on the ACO's quality performance.
After consideration of the public comments received, we are finalizing, with modifications, the proposed approach to determine financial and quality performance for ACOs participating in a 6-month performance year from January 1, 2019 through June 30, 2019, as specified in paragraphs (a) and (b) of a new section of the regulations at § 425.609. These modifications are necessary because this final rule only addresses the 6-month extension period, and does not address our proposal to establish a July 1, 2019 agreement start date. In summary, we will do the following to determine an ACO's financial and quality performance during the 6-month performance year from January 1, 2019 through June 30, 2019: We will compare the ACO's historical benchmark updated to CY 2019 to the expenditures during CY 2019 for the ACO's performance year assigned beneficiaries. If the difference is positive and is greater than or equal to the MSR and the ACO has met the quality performance standard, the ACO will be eligible for shared savings. If the ACO is in a two-sided model and the difference between the updated benchmark and assigned beneficiary expenditures is negative and is greater than or equal to the MLR (in absolute value terms), the ACO will be liable for shared losses. ACOs will share in first dollar savings and losses. The amount of any shared savings will be determined using the applicable final sharing rate, which is determined based on the ACO's track for the applicable agreement period, and taking into account the ACO's quality performance for 2019.
We will adjust the amount of shared savings for sequestration, and then cap the amount of shared savings at the applicable performance payment limit for the ACO's track. Similarly, the amount of any shared losses will be determined using the loss sharing rate for the ACO's track and, as applicable, for ACOs in tracks with a loss sharing rate that depends upon quality performance, the ACO's quality performance for 2019.We will then cap the amount of shared losses at the applicable loss sharing limit for the ACO's track. We will then pro-rate any shared savings or shared losses by
Because we are not addressing the proposed July 1, 2019 agreement period start date for the proposed new BASIC track and ENHANCED track at this time, we note the following differences between our proposed approach (which contemplated that ACOs may be participating in both a 6-month performance year from January 1, 2019 through June 30, 2019, and a 6-month performance year from July 1, 2019 through December 31, 2019) and our final policies (which are limited to the 6-month performance year from January 1, 2019 through June 30, 2019, for eligible ACOs that elect to extend their agreement period, which would otherwise expire on December 31, 2018):
• We are omitting references that we proposed to include in § 425.609(b) in order to establish the applicability of these policies to ACOs that begin a 12-month performance year on January 1, 2019, but elect to terminate their participation agreement with an effective date of termination of June 30, 2019, in order to enter a new agreement period starting on July 1, 2019 (early renewals). We are also making clarifying revisions to the introductory text in § 425.609(b).
• As described in section V.B.1.c.(4) of this final rule we are finalizing a subset of our proposals for identifying the ACO participant list used in determining quality reporting samples for ACOs participating in a 6-month performance year from January 1, 2019 through June 30, 2019. We are finalizing our proposal to use the ACO's latest certified ACO participant list (the ACO participant list effective on January 1, 2019) to determine the quality reporting samples for the 2019 reporting period.
• We are not addressing at this time the proposals for modifying the MSR/MLR to address small population sizes (83 FR 41837 through 41839). Therefore, the policies for determining shared savings and shared losses in the event the ACO's assigned population falls below 5,000, as specified under the program's current regulations at § 425.110, would apply to ACOs participating in a 6-month performance year from January 1, 2019 through June 30, 2019. Therefore, we will specify in § 425.609(b)(3)(ii)(C)(
• We are also reserving paragraph (c) of § 425.609 in the event that we finalize policies for a second 6-month performance year during CY 2019 in the future.
In section V.B.1.c. of this final rule, we discuss our decision to finalize other provisions from the August 2018 proposed rule related to determining performance for the 6-month performance year, as specified in paragraphs (d) and (e) of § 425.609.
In the August 2018 proposed rule (83 FR 41854), we proposed that program requirements under 42 CFR part 425 that are applicable to the ACO under the ACO's chosen participation track and based on the ACO's agreement start date would be applicable to an ACO participating in a 6-month performance year, unless otherwise stated. We received no comments on this general proposal and we are finalizing this general approach as proposed. As we explained in the August 2018 proposed rule, this approach will allow routine program operations to continue to apply for ACOs participating under a shorter performance year. Further, it will ensure consistency in the applicability and implementation of our requirements across all program participants, including ACOs participating in a 6-month performance year.
In section V.B.1.b. of this final rule, we describe limited exceptions to our general policies for determining financial and quality performance which are necessary to ensure calculations can continue to be performed on a calendar year basis and using the most relevant data.
In this section, we describe program participation options affected by our decision to forgo an application cycle in CY 2018 for a January 1, 2019 start date, and offer a voluntary extension to allow ACOs whose agreement periods expire on December 31, 2018, to continue their participation in the program for a 6-month performance year from January 1, 2019 through June 30, 2019. We discuss modifications to program policies to allow for the 6-month performance year and related revisions to the program's regulations. As discussed in section II.A.7.c. of the August 2018 proposed rule (83 FR 41854 through 41860), these proposals were developed, in part, based on our proposal to offer an application cycle in CY 2019 for a July 1, 2019 start date. Therefore, we considered that some ACOs would participate in the program for both the 6-month performance year (or performance period) from January 1, 2019 through June 30, 2019, and the 6-month performance year from July 1, 2019 through December 31, 2019, while other ACOs would only participate in one of these performance years. In this final rule, we do not address the considerations related to the proposed July 1, 2019 agreement period start date because we are not addressing the proposal to offer that start date at this time.
Eligible ACOs may apply for use of a SNF 3-day rule waiver at the time of application for an initial agreement or to renew their participation. Further, as described in sections II.B.2.a. and II.F. of the August 2018 proposed rule (83 FR 41860, 41912), ACOs within a current agreement period under Track 3, or the Track 1+ Model may apply for a SNF 3-day rule waiver, which, if approved, would begin at the start of their next performance year.
In light of our decision to forgo an application cycle in CY 2018 for a January 1, 2019 agreement period start date, we are also not offering an opportunity for ACOs to apply for a start date of January 1, 2019, for initial use of a SNF 3-day rule waiver. We proposed that, if finalized, the next available application cycle for a SNF 3-day rule waiver would occur in advance of a July 1, 2019 start date. Absent further rulemaking to establish participation options for a start date in 2019 that includes an opportunity for ACOs within existing agreement periods in Track 3 or the Track 1+ Model to apply for a SNF 3-day rule waiver, these ACOs would not have the opportunity to apply to begin use of the waiver until January 1, 2020.
At the end of each performance year, ACOs complete an annual certification process. At the same time as this annual certification process, CMS also requires ACOs to review, certify and electronically sign official program
Each ACO is required to certify its list of ACO participant TINs before the start of its agreement period, before every performance year thereafter, and at such other times as specified by CMS in accordance with § 425.118(a). A request to add ACO participants must be submitted prior to the start of the performance year in which these additions would become effective. An ACO must notify CMS no later than 30 days after termination of an ACO participant agreement, and the entity is deleted from the ACO participant list effective as of the termination date of the ACO participant agreement. Absent unusual circumstances, the ACO participant list that was certified prior to the start of the performance year is used to determine beneficiary assignment for the performance year and therefore also the ACO's quality reporting samples and financial performance. See § 425.118(b)(3) and see also Medicare Shared Savings Program ACO Participant List and Participant Agreement Guidance (July 2018, version 5), available at
As we explained in the August 2018 proposed rule (83 FR 41855), ACOs that started a first or second agreement period on January 1, 2016, that extend their agreement period for a 6-month performance year beginning on January 1, 2019, would have the opportunity during 2018 to make changes to their ACO participant list to be effective for the 6-month performance year from January 1, 2019, to June 30, 2019. To prepare for the possible implementation of this 6-month performance year, we allowed ACOs that started a first or second agreement period on January 1, 2016, to submit change requests in accordance with usual program procedures to indicate additions, updates, and deletions to their existing ACO participant lists, and if applicable, SNF affiliate lists.
The program's current regulations prevent duplication of shared savings payments; thus, under § 425.114, ACOs may not participate in the Shared Savings Program if they include an ACO participant that participates in another Medicare initiative that involves shared savings. In addition, under § 425.306(b)(2), each ACO participant that submits claims for services used to determine the ACO's assigned population must be exclusive to one Shared Savings Program ACO. If, during a benchmark or performance year (including the 3-month claims run out for such benchmark or performance year), an ACO participant that participates in more than one ACO submits claims for services used in assignment, then CMS will not consider any services billed through the TIN of the ACO participant when performing assignment for the benchmark or performance year; and the ACO may be subject to the pre-termination actions set forth in § 425.216, termination under § 425.218, or both.
As a result, all ACOs, including those ACOs that will be eligible to elect the voluntary 6-month extension that we are finalizing this final rule, had multiple opportunities to submit change requests to add ACO participants and/or SNF affiliates for performance years starting on January 1, 2019. We also launched a new ACO management system during 2018 that is more user friendly, provides faster feedback, and encourages ACOs to submit change requests to add ACO participants and SNF affiliates with fewer errors than the system that was available in previous years. We do not believe it is operationally feasible to extend the date for ACOs to submit change requests after September 28, 2018, the date we communicated to ACOs as being the deadline to add ACO participants to be effective for performance years beginning on January 1, 2019. Allowing change requests seeking to add new ACO participants to be submitted very close to the end of the calendar year would not provide sufficient time to review and screen providers/suppliers for program integrity issues and create 2019 assignment list reports, and may have other operational impacts (such as on timely production of certain other program reports). We note, however, ACO participants can be terminated and deleted from the ACO participant list at any time during a performance year. The ACO participant is no longer an ACO participant as of the termination effective date of the ACO participant agreement. Absent unusual circumstances, however, the ACO participant data will continue to be utilized for certain operational purposes.
ACOs must demonstrate that they have in place an adequate repayment mechanism prior to entering a two-sided model. The repayment mechanism must be in effect for the duration of an ACO's participation in a two-sided model and for a sufficient period of time after the conclusion of the agreement period to permit CMS to calculate the amount of
In the August 2018 proposed rule (83 FR 41856), we noted that ACOs that started a first or second agreement period on January 1, 2016, in a two-sided model would have in place under current program policies a repayment mechanism arrangement that would cover the 3 years between January 1, 2016 and December 31, 2018, plus a 24-month tail period until December 31, 2020. We would expect an ACO with an agreement period ending December 31, 2018, that extends its agreement for the 6-month performance year from January 1, 2019 through June 30, 2019, to likewise extend the term of its repayment mechanism so that it will be in effect for the duration of the ACO's participation in a two-sided model plus 24 months following the conclusion of the agreement period (that is, until June 30, 2021). This would allow us sufficient time to perform financial calculations for the 6-month performance year from January 1, 2019 through June 30, 2019, and to use the arrangement to collect shared losses for that performance year, if necessary.
In a forthcoming final rule, we expect to summarize and respond to comments on our proposed changes to § 425.204(f) regarding repayment mechanism requirements for ACOs that are in a two-sided model.
In addition, we have notified ACOs participating under a two-sided model that if they elect the 6-month extension from January 1, 2019 through June 30, 2019 then we expect that they will extend their repayment mechanisms in accordance with § 425.204(f)(4). As we noted in our
We acknowledge that amending certain repayment mechanism arrangements could come at additional costs to ACOs. However, we believe it necessary that the repayment mechanism arrangements comply with Shared Savings Program and Track 1+ Model policy to ensure the ACO can repay losses for which it may be liable.
As described in the August 2018 proposed rule (83 FR 41856 through 41858), to determine an ACO's quality performance for the 6-month performance year from January 1, 2019 through June 30, 2019, we proposed to use the ACO's quality performance for the 2019 reporting period as determined under § 425.502. Under this proposed approach, we would account for the ACO's quality performance using quality measure data reported for the 12-month CY 2019.
As we explained in the August 2018 proposed rule, the following considerations support this proposed approach. For one, use of a 12-month period for quality measure assessment maintains alignment with the program's existing quality measurement approach, and aligns with the proposed use of 12 months of expenditure data (for CY 2019) in determining the ACO's financial performance. Also, this approach would continue to align the program's quality reporting period with policies under the Quality Payment Program. ACO professionals that are MIPS eligible clinicians (not QPs based on their participation in an Advanced APM or otherwise excluded from MIPS) would continue to be scored under MIPS using the APM scoring standard that covers all of 2019. Second, the measure specifications for the quality measures used under the program require 12 months of data. See for example, the Shared Savings Program ACO 2018 Quality Measures Narrative Specification Document (January 20, 2018), available at
The ACO participant list is used to determine beneficiary assignment for purposes of generating the quality reporting samples. Beneficiary assignment is performed using the applicable assignment methodology under § 425.400, either preliminary prospective assignment or prospective assignment, with excluded beneficiaries removed under § 425.401(b), as applicable. The samples for claims-based measures are typically
For purposes of determining the quality reporting samples for the 2019 reporting period, we proposed to use the ACO's most recent certified ACO participant list available at the time the quality reporting samples are generated, and the assignment methodology most recently applicable to the ACO for a 2019 performance year. We explained our belief that the use of the ACO's most recent certified ACO participant list to assign beneficiaries according to the assignment methodology applicable based on the ACO's most recent participation in the program during 2019 would result in the most relevant beneficiary samples for 2019 quality reporting. Additionally, we believed this proposed approach to determining the ACO's quality reporting samples was also appropriate for an ACO that participated in only one 6-month performance year during 2019 because the most recent certified ACO participant list applicable for the performance year would also be the certified ACO participant list that is used to determine financial performance.
We proposed two approaches to determine the certified ACO participant list, assignment methodology, and assignment window that would be used to generate the quality reporting samples for measuring quality performance of ACOs participating in the 6-month performance year from January 1, 2019 through June 30, 2019. One approach was applicable to ACOs that enter a new agreement period under the proposed July 1, 2019 agreement start date, including ACOs that extended their prior participation agreement for the 6-month performance year from January 1, 2019, to June 30, 2019. For ACOs that enter a new agreement period beginning on July 1, 2019, we proposed to use the certified ACO participant list for the performance year starting on July 1, 2019, to determine the quality reporting samples for the 2019 reporting period. This most recent certified ACO participant list would therefore be used to determine the quality reporting samples for the 2019 reporting year. A second approach was proposed for an ACO that extends its participation for the first 6 months of 2019, but does not enter a new agreement period beginning on the proposed July 1, 2019 agreement start date. This second approach is relevant to the policies we are finalizing in this final rule, for the 6-month performance year from January 1, 2019 through June 30, 2019, for ACOs whose current participation agreements expire on December 31, 2018, and that voluntarily elect to extend their agreement period for a fourth performance year. Under this approach, we proposed to use the ACO's latest certified participant list (the ACO participant list effective on January 1, 2019) to determine the quality reporting samples for the 2019 reporting period. Beneficiary assignment for purposes of generating the quality reporting samples would be based on the assignment methodology applicable to the ACO during its 6-month performance year from January 1, 2019 through June 30, 2019, under § 425.400, either preliminary prospective assignment or prospective assignment, with excluded beneficiaries removed under § 425.401(b), as applicable. We anticipated that the assignment windows for the quality reporting samples would be as follows, based on our operational experience: (1) Samples for claims-based measures would be determined based on the assignment list for calendar year quarter 4; (2) the sample for CMS Web Interface measures would be determined based on the assignment list for calendar year quarter 3; and (3) the sample for the CAHPS for ACOs survey would be determined based on the assignment list for calendar year quarter 2. We noted that this approach would maintain alignment with the assignment windows currently used for establishing quality reporting samples for these measures.
We proposed to specify the certified ACO participant list that would be used in determining the quality reporting samples for measuring quality performance for the 6-month performance year from January 1, 2019 through June 30, 2019, in a new section of the regulations at § 425.609(b).
We also note that for the 2019 reporting period, ACOs would be required to report quality data through the CMS Web Interface, according to the method and timing of submission established by CMS. The period for reporting quality data through the CMS Web Interface typically occurs for a 12-week period between January and March, following the conclusion of the calendar year. Thus, ACOs that participate in a 6-month performance year from January 1, 2019 through June 30, 2019, along with all other Shared Savings Program ACOs would be required to report for the 2019 reporting period, and would report quality data through the CMS Web Interface during the designated reporting period in early 2020. Further, ACOs participating in the 6-month performance year from January 1, 201 through June 30, 2019, would be required to contract with a CMS-approved vendor to administer the CAHPS for ACOs survey for the 2019 reporting period, consistent with program-wide policies applicable to all other ACOs. We would apply the program's sampling methodology, as we have described in the August 2018 proposed rule and this section of this final rule, to determine the beneficiaries eligible for the samples for claims-based measures (as calculated by CMS), CMS
After consideration of the comments, we are finalizing without modification our proposal to determine an ACO's quality performance for the 6-month performance year from January 1, 2019 through June 30, 2019, using the ACO's quality performance for the 12-month CY 2019 (2019 reporting period) as determined under § 425.502. We are also finalizing a subset of our proposals for identifying the ACO participant list used in determining quality reporting samples for ACOs participating in a 6-month performance year from January 1, 2019 through June 30, 2019. Given the limited scope of this final rule we are finalizing our proposal to use an ACO's latest certified ACO participant list for the performance year from January 1, 2019 through June 30, 2019, (the ACO participant list effective on January 1, 2019) to determine the quality reporting samples for the 2019 reporting period. We are not addressing at this time our proposals related to the proposed July 1, 2019 agreement start date, including the policies for determining the quality reporting samples for ACOs that extend their participation agreement for the 6-month performance year from January 1, 2019 through June 30, 2019, and continue their participation in the program in a new agreement period beginning on July 1, 2019. We anticipate summarizing and responding to comments received on these proposals in a forthcoming final rule.
In section II.E.4 of the August 2018 proposed rule (83 FR 41899 through 41906), we proposed to extend the policies for addressing the impact of extreme and uncontrollable circumstances on ACO financial and quality performance results for performance year 2017 to performance year 2018 and subsequent years. As discussed in section V.B.2.d of this final rule, we are finalizing this proposal. In section II.E.4. of the August 2018 proposed rule, we indicated that if finalized, these policies would apply to ACOs participating in the 6-month performance year from January 1, 2019 through June 30, 2019.
There were no comments directed specifically at our proposals with respect to the applicability of these policies for addressing the impact of extreme and uncontrollable circumstances on ACOs participating in a 6-month performance year from January 1, 2019 through June 30, 2019. We direct readers to review section V.B.2.d. of this final rule, for a more comprehensive discussion of the modifications to the program's extreme and uncontrollable circumstances policies that we are finalizing with this final rule.
We are finalizing as proposed the policies for determining the financial and quality performance for the 6-month performance year from January 1, 2019 through June 30, 2019, for ACOs affected by extreme and uncontrollable circumstances during CY 2019. In addition, we are also finalizing our proposal to specify, in a new section of the regulations at § 425.609(d), the following policies related to determining the financial and quality performance for the 6-month performance year from January 1, 2019 through June 30, 2019, for an ACO affected by extreme and uncontrollable circumstances during CY 2019: (1) In calculating the amount of shared losses owed by the ACO, CMS makes adjustments to the amount determined under § 425.609(b), as specified in § 425.606(i) (Track 2) or § 425.610(i) (Track 3), as applicable; and (2) in determining the ACO's quality performance score for the 2019 quality reporting period, CMS uses the alternative scoring methodology specified in § 425.502(f).
In the August 2018 proposed rule (83 FR 41858), we proposed policies regarding CMS' notification to ACOs of shared savings and shared losses and the timing for ACOs' repayment of shared losses for both the 6-month performance year (or performance period) from January 1, 2019 through June 30, 2019, and the 6-month performance year from July 1, 2019 through December 31, 2019.
In this final rule, we are addressing the proposals specific to the 6-month performance year from January 1, 2019 through June 30, 2019. In a forthcoming final rule, we anticipate discussing comments received on the proposals related to payment and recoupment for the 6-month performance year from July 1, 2019 through December 31, 2019, and the performance period from January 1, 2019 through June 30, 2019, for ACOs that terminate their agreement effective June 30, 2019, and enter a new agreement period starting on July 1, 2019. We anticipate this final rule would include a discussion of our proposal to reduce the shared savings payment for one 6-month performance year (or performance period) by the amount of any shared losses owed for the other 6-month performance year (or performance period).
In the August 2018 proposed rule, we proposed that the following policies would be applicable to ACOs that elect a 6-month extension for the performance year from January 1, 2019 through June 30, 2019. Because we proposed to perform financial reconciliation for this 6-month performance year after the end of CY 2019, we anticipated that financial performance reports for the 6-month performance year would be available in Summer 2020, similar to the expected timeframe for issuing financial performance reports for the 12-month 2019 performance year (and for 12-month performance years generally).
We proposed to apply the same policies regarding notification of shared savings and shared losses and the timing of repayment of shared losses to ACOs in a 6-month performance year that apply under our current regulations to ACOs in 12-month performance years. For the 6-month performance year from January 1, 2019 through June 30, 2019, we proposed to specify in a new regulation at § 425.609 that CMS would notify the ACO of shared savings or shared losses, consistent with the notification requirements specified in § 425.604(f) (Track 1), § 425.606(h) (Track 2), and § 425.610(h) (Track 3). Specifically, we proposed that the following approach: (1) CMS notifies an ACO in writing regarding whether the ACO qualifies for a shared savings payment, and if so, the amount of the payment due; (2) CMS provides written notification to an ACO of the amount of shared losses, if any, that it must repay to the program; (3) if an ACO has shared losses, the ACO must make payment in full to CMS within 90 days of receipt of notification.
We proposed to specify policies on payment and recoupment for ACOs in a 6-month performance year during CY 2019 in a new section of the regulations at § 425.609(e).
We are finalizing without modification our proposal to specify in a new section of the regulations at § 425.609(e) that CMS will notify the ACO of shared savings or shared losses for the 6-month performance year from January 1, 2019 through June 30, 2019, consistent with the notification requirements specified in §§ 425.604(f), 425.606(h), and 425.610(h), as applicable. Specifically, we will notify an ACO in writing regarding whether the ACO qualifies for a shared savings payment, and if so, the amount of the payment due. CMS will provide written notification to an ACO of the amount of shared losses, if any, that the ACO must repay to the program. If an ACO has shared losses, the ACO must make payment in full to CMS within 90 days of receipt of notification.
In the August 2018 proposed rule (83 FR 41859), we took into consideration how the proposed July 1, 2019 start date could interact with other Medicare initiatives, particularly the Quality Payment Program timelines relating to participation in APMs. In the CY 2018 Quality Payment Program final rule with comment period, we finalized a policy for APMs that start or end during the QP Performance Period. Specifically, under § 414.1425(c)(7)(i), for Advanced APMs that start during the QP Performance Period and are actively tested for at least 60 continuous days during a QP Performance Period, CMS will make QP determinations and Partial QP determinations for eligible clinicians in the Advanced APM using claims data for services furnished during those dates on which the Advanced APM is actively tested. CMS performs QP determinations for eligible clinicians in an APM entity three times during the QP Performance Period using claims data for services furnished from January 1 through each of the respective QP determination dates: March 31, June 30, and August 31 (§ 414.1425(b)(1)). We explained that this meant that an APM (such as a two-sided model of the Shared Savings Program) would need to begin operations by July 1 of a given performance year in order to be actively tested for at least 60 continuous days before August 31—the last date on which QP determinations are made during a QP Performance Period (as specified in § 414.1425(b)(1)). Therefore, we believed that our proposed July 1, 2019 start date for the proposed new participation options under the Shared Savings Program would align with Quality Payment Program rules and requirements for participation in Advanced APMs. However, we did not address QP determinations for eligible clinicians participating in an ACO whose agreement period expires on December 31, 2018, that elects a voluntary extension for the 6-month performance year from January 1, 2019 through June 30, 2019, and does not continue in the program past June 30, 2019.
Further, as described in section II.A.7.c.(4) of the August 2018 proposed rule (83 FR 41856), our proposal to use a 12-month period for quality measure assessment for either 6-month performance year during 2019 would maintain alignment with the program's existing quality measurement approach, and align with the proposed use of 12 months of expenditure data (for CY 2019) in determining the ACO's financial performance for a 6-month performance year. Also, this approach would continue to align the program's quality reporting period with policies under the Quality Payment Program (83 FR 41856). We explained that ACO professionals that are MIPS eligible clinicians (not QPs based on their participation in an Advanced APM or otherwise excluded from MIPS) would continue to be scored under MIPS using the APM scoring standard that covers all of 2019.
We also believe there is a need to clarify what happens to an eligible clinician's QP status if they are participating in an ACO that is in a track that meets the Advanced APM criteria and elects to extend for the 6-month performance year from January 1, 2019 through June 30, 2019, and either voluntarily terminates or is involuntarily terminated prior to June 30, 2019. If their ACO terminates or is involuntarily terminated any time after March 31, 2019, and before August 31, 2019, then eligible clinicians previously determined to have had QP status would lose their status as a result of the termination, and would instead be scored under MIPS using the APM Scoring Standard (§ 414.1425(c)(5) and (6)). If their ACO terminates before March 31, 2019, then the eligible clinicians would not be scored under the APM Scoring Standard and will be
As discussed in this section of this final rule, we are finalizing a policy of using a 12-month period for quality performance assessment for the 6-month performance year from January 1, 2019 through June 30, 2019, in order to maintain alignment with the program's existing quality measurement approach, and with policies under the Quality Payment Program. ACO professionals that are MIPS eligible clinicians (not QPs based on their participation in an Advanced APM or otherwise excluded from MIPS) participating in an ACO that completes a 6-month performance year from January 1, 2019 through June 30, 2019, would continue to be scored under MIPS using the APM Scoring Standard, based on quality data submitted for all of 2019 during the regular submission period in early 2020. Thus, for a Track 1 ACO in a 6-month performance year from January 1, 2019 through June 30, 2019, whose agreement period expires and the ACO does not renew to continue program participation, the ACO would be scored under the MIPS APM scoring rules for quality reporting based on the entire CY 2019.
Under the program's current regulations at § 425.702, we share aggregate data with ACOs during the agreement period. This includes providing data at the beginning of each performance year, during each quarter, and in conjunction with the annual reconciliation. In the August 2018 proposed rule (83 FR 41859), for ACOs that started a first or second agreement period on January 1, 2016, that extend their agreement for an additional 6-month performance year from January 1, 2019 through June 30, 2019, we proposed to continue to deliver aggregate reports for all four quarters of CY 2019 based on the ACO participant list in effect for the 6-month performance year. This would give ACOs a more complete understanding of the Medicare FFS beneficiary population that is the basis for reconciliation for the 6-month performance year by allowing them to continue to receive data, including demographic characteristics and expenditure/utilization trends for their assigned population for the entire calendar year. We believed this proposed approach would allow us to maintain transparency by providing ACOs with data that relates to the entire period for which the expenditures for the beneficiaries assigned to the ACO for the 6-month performance year would be compared to the ACO's benchmark (before pro-rating any shared savings or shared losses to reflect the length of the performance year), and maintain consistency with the reports delivered to ACOs that participate in a 12-month performance year 2019. Otherwise, we could be limited to providing ACOs with aggregate reports only for the first and second quarters of 2019, even though under our proposed methodology for assessing the financial performance of ACOs in a 6-month performance year, the financial reconciliation for the 6-month performance year would involve consideration of expenditures from outside this period during 2019. We proposed to specify this policy in revisions to § 425.702.
After consideration of the comments received, we are finalizing our proposal to deliver to ACOs participating in a 6-month performance year from January 1, 2019 through June 30, 2019, aggregate reports for all four quarters of CY 2019 based on the ACO participant list in effect for the performance year. This policy is specified in revisions to § 425.702.
In the August 2018 proposed rule (83 FR 41859 through 41860), we proposed to make certain technical, conforming changes to certain provisions of the regulations, including additional changes to provisions discussed elsewhere in the proposed rule, to reflect our proposal to add a new provision at § 425.609 to govern the calculation of the financial and quality results for the proposed 6-month performance years within CY 2019.
In this final rule, we are addressing only the proposals specific to the6-month performance year from January 1, 2019 through June 30, 2019. In a forthcoming final rule, we anticipate discussing comments received on the proposed 6-month performance year from July 1, 2019 through December 31, 2019, and the proposed 6-month performance period from January 1, 2019 through June 30, 2019, for ACOs that terminate their agreement effective June 30, 2019, and enter a new agreement period starting on July 1, 2019.
The following proposals discussed in the August 2018 proposed rule would be applicable to ACOs that elect a6-month extension for the performance year from January 1, 2019 through June 30, 2019.
Our proposal that the policies on reopening determinations of shared savings and shared losses to correct financial reconciliation calculations (§ 425.315) would apply with respect to applicable payment determinations for performance years within CY 2019. To clarify, we proposed to amend § 425.315 to incorporate a reference to the proposed provision for notification of shared savings and shared losses for ACOs in a 6-month performance year within CY 2019, as specified in § 425.609(e).
Our proposal to add a reference to § 425.609 in § 425.100 in order to include ACOs that participate in a6-month performance year during 2019 in the general description of ACOs that are eligible to receive payments for shared savings under the program.
Our proposal to amend § 425.400(a)(1)(ii), which describes the step-wise process for determining beneficiary assignment for each performance year, to specify that this process would apply to ACOs participating in a 6-month performance year within CY 2019, and that assignment would be determined based on the beneficiary's utilization of primary care services during the entirety of CY 2019, as specified in § 425.609.
Our proposal to further revise § 425.400(c)(1)(iv), on the use of certain Current Procedural Terminology (CPT) codes and Healthcare Common Procedure Coding System (HCPCS) codes in determining beneficiary assignment, to specify that it would be used in determining assignment for performance years starting on January 1, 2019, and subsequent years. We note that we also proposed certain other revisions to this provision in section II.E.3. of the August 2018 proposed rule (83 FR 41896), as discussed in section V.B.2.c. of this final rule.
Our proposal to revise § 425.401(b), describing the exclusion of beneficiaries from an ACO's prospective assignment list at the end of a performance year or benchmark year and quarterly during each performance year, to specify that these exclusions would occur at the end of CY 2019 for purposes of determining assignment to an ACO in a 6-month performance year in accordance with §§ 425.400(a)(3)(ii) and 425.609.
Our proposal, as part of the proposed revisions to § 425.402(e)(2), which, as described in section II.E.2. of the August 2018 proposed rule (83 FR 41894), specifies that beneficiaries who have designated a provider or supplier outside the ACO as responsible for coordinating their overall care will not be added to the ACO's list of assigned beneficiaries for a performance year under the claims-based assignment methodology, to allow the same policy to apply to ACOs participating in a6-month performance year during CY 2019. We are finalizing our proposed revisions to § 425.402(e)(2), as described in section V.B.2.b. of this final rule.
Our proposal to revise § 425.404(b), on the special assignment conditions for ACOs that include FQHCs and RHCs that provide services used in determining beneficiary assignment, to specify its applicability in determining assignment for performance years starting on January 1, 2019, and subsequent performance years.
We also proposed to incorporate references to § 425.609 in the regulations that govern establishing, adjusting, and updating the benchmark, including the existing provisions at §§ 425.602 and 425.603, to specify that the annual risk adjustment and update to the ACO's historical benchmark for the 6-month performance year from January 1, 2019 through June 30, 2019, would use factors based on the entirety of CY 2019. For clarity and simplicity, we proposed to add a paragraph to each of these sections to explain the following: (1) Regarding the annual risk adjustment applied to the historical benchmark, when CMS adjusts the benchmark for the 6-month performance year from January 1, 2019 through June 30, 2019, the adjustment will reflect the change in severity and case mix between benchmark year 3 and CY 2019; (2) Regarding the annual update to the historical benchmark, when CMS updates the benchmark for the 6-month performance year from January 1, 2019 through June 30, 2019, the update to the benchmark will be based on growth between benchmark year 3 and CY 2019.
We also proposed to incorporate references to § 425.609 in the following provisions regarding the calculation of shared savings and shared losses: §§ 425.604, 425.606, and 425.610. For clarity and simplicity, we proposed to add a paragraph to each of these sections explaining that shared savings or shared losses for the 6-month performance year from January 1, 2019 through June 30, 2019, are calculated as described in § 425.609. That is, all calculations will be performed using CY 2019 data in place of performance year data.
There were no comments directed specifically at our proposed technical and conforming changes to allow for6-month performance years. We are finalizing as proposed the technical and conforming changes to the Shared Savings Program regulations as previously described in this section of this final rule, to allow them to apply to ACOs participating in a 6-month performance year from January 1, 2019 through June 30, 2019.
In the August 2018 proposed rule (83 FR 41845 through 41847), we proposed policies to govern the payment consequences of early termination for performance years beginning in 2019 and subsequent years, including for ACOs participating in 6-month performance years from January 1, 2019 through June 30, 2019, and July 1, 2019 through December 31, 2019, as well as for ACOs participating in 12-month performance years. We proposed to impose payment consequences for early termination by holding ACOs in two-sided models liable for pro-rated shared losses. This approach would apply to ACOs that voluntarily terminate their participation more than midway through a 12-month performance year and all ACOs that are involuntarily terminated by CMS. ACOs would be ineligible to share in savings for a performance year if the effective date of their termination from the program is prior to the last calendar day of the performance year; but, we would allow an exception for ACOs that are participating in a 12-month performance year under the program as of January 1, 2019, that terminate their agreement with an effective date of June 30, 2019, and enter a new agreement period under the proposed BASIC track or ENHANCED track beginning July 1, 2019. In these cases, we would perform separate reconciliations to determine shared savings and shared losses for the ACO's first 6 month period of participation in 2019 and for the ACO's 6-month performance year from July 1, 2019, to December 31, 2019, under the subsequent participation agreement.
In a forthcoming final rule we anticipate addressing comments received on proposals for the payment consequences of early termination from 12-month performance years and from 6-month performance years beginning on July 1, 2019, should we finalize the proposal to offer a July 1, 2019 start date for the new participation options. Therefore, in this section of this final rule we focus specifically on the proposals regarding the payment consequences of early termination as they relate to the 6-month performance
We proposed that an ACO would be eligible to receive shared savings for a 6-month performance year during 2019 if it completes the term of the performance year, regardless of whether the ACO chooses to continue its participation in the program. That is, we would reconcile ACOs that started a first or second agreement period January 1, 2016, that extend their agreement period for a fourth performance year, and complete this performance year (concluding on June 30, 2019).
For an ACO that participates for a portion of a 6-month performance year during 2019, we proposed the following: (1) If the ACO terminates its participation agreement effective before the end of the performance year, we would not reconcile the ACO for shared savings or shared losses (if a two-sided model ACO); (2) if CMS terminates a two-sided model ACO's participation agreement effective before the end of the performance year, the ACO would not be eligible for shared savings and we would reconcile the ACO for shared losses and pro-rate the amount reflecting the number of months during the performance year that the ACO was in the program. We proposed to specify these policies in amendments to § 425.221(b).
We also proposed to revise the regulation at § 425.221 to streamline and reorganize the provisions in paragraph (b), which we believed necessary to incorporate the proposed new requirements. We sought comment on these proposals.
We are not addressing our proposed modifications to program policies to impose payment consequences for early termination in this final rule. Accordingly, for ACOs participating in a performance year starting on January 1, 2019, we will continue to apply the program's current policies for payment consequences of early termination. We believe that continuing to use the current approach would be simpler, both from the standpoint of CMS as the regulatory entity and operator of the program, and for ACOs as regulated entities already familiar with the current policies. Under this approach, ACOs that terminate from a performance year starting on January 1, 2019, with an effective date of termination prior to the end of their performance year will not be eligible for shared savings or accountable for shared losses.
At this time, we are finalizing a subset of our proposed policies for determining payment consequences of early termination, to account for ACOs participating in a 6-month performance year from January 1, 2019 through June 30, 2019. Specifically, we are finalizing without modification our proposal that an ACO participating in a 6-month performance year from January 1, 2019 through June 30, 2019, is eligible for shared savings if the following conditions are met: CMS has designated or approved an effective date of termination that is the last calendar day of the performance year (June 30, 2019); the ACO has completed all close-out procedures specified in § 425.221(a) by the deadline specified by CMS (if applicable); and the ACO has satisfied the criteria for sharing in savings for the performance year. Consistent with our existing policies, if the participation agreement is terminated at any time by CMS under § 425.218, the ACO will not be eligible to receive shared savings for the performance year during which the termination becomes effective, and will not be accountable for any shared losses. Further, for an ACO participating in a 6-month performance year from January 1, 2019 through June 30, 2019, that elects to terminate early, we will apply the payment consequences of early termination consistent with the current regulations, and the ACO will not be eligible to receive shared savings for the performance year and will not be accountable for any shared losses.
We are finalizing the proposed revisions to § 425.221 to allow us to consistently apply current program policies on the payment consequences of early termination or agreement expiration to ACOs in a 6-month performance year from January 1, 2019 through June 30, 2019. We are amending § 425.221(b) to remove references to December 31st of a performance year and instead to refer to the last calendar day of the performance year, so that the regulatory provisions will apply to ACOs regardless of whether they are participating in a 12-month or 6-month performance year. We are not addressing at this time the other proposed revisions to the regulation at § 425.221, including the proposals to streamline and reorganize the provisions in paragraph (b).
This section addresses various proposed revisions described in the August 2018 proposed rule (83 FR 41894 through 41911) that are designed to update policies under the Shared Savings Program. We proposed to revise our regulations governing the assignment process in order to align our voluntary alignment policies with the requirements of section 50331 of the Bipartisan Budget Act of 2018 and to update the definition of primary care services. We also proposed to extend the policies that we recently adopted for ACOs impacted by extreme and uncontrollable circumstances during 2017 to 2018 and subsequent performance years. We also solicited comment on considerations related to supporting ACOs' activities to address the national opioid crisis and the agency's meaningful measures initiative. We proposed to discontinue use of the quality performance measure that assesses the level of adoption of CEHRT by the eligible clinicians in an ACO and proposed instead that ACOs be required to certify upon application to participate in the Shared Savings Program and annually thereafter that the percentage of eligible clinicians participating in the ACO using CEHRT to document and communicate clinical care to their patients or other health care providers meets or exceeds certain thresholds.
Section 50331 of the Bipartisan Budget Act of 2018 amended section 1899(c) of the Act (42 U.S.C. 1395jjj(c)) to add a new paragraph (2)(B) that requires the Secretary, for performance year 2018 and each subsequent performance year, to permit a Medicare FFS beneficiary to voluntarily identify an ACO professional as the primary care provider of the beneficiary for purposes of assigning such beneficiary to an ACO, if a system is available for electronic designation. A voluntary identification by a Medicare FFS beneficiary under this provision supersedes any claims-based assignment otherwise determined by the Secretary. Section 50331 also requires the Secretary to establish a process under which a Medicare FFS beneficiary is notified of his or her ability to designate a primary care provider or subsequently to change this designation. An ACO professional is defined under section 1899(h) of the Act as a physician as defined in section 1861(r)(1) of the Act and a practitioner described in section 1842(b)(18)(C)(i) of the Act.
As we stated in the August 2018 proposed rule (83 FR 41894), we believe that section 50331 requires certain revisions to our current beneficiary voluntary alignment policies in § 425.402(e). Prior to enactment of the Bipartisan Budget Act of 2018, section 1899(c) of the Act required that beneficiaries be assigned to an ACO based on their use of primary care services furnished by a physician as
Notwithstanding the assignment methodology in § 425.402(b), beneficiaries who designate an ACO professional whose services are used in assignment as responsible for their overall care will be prospectively assigned to the ACO in which that ACO professional participates, provided the beneficiary meets the eligibility criteria established at § 425.401(a) and is not excluded from assignment by the criteria in § 425.401(b), and has had at least one primary care service during the assignment window with an ACO professional in the ACO who is a primary care physician as defined under § 425.20 or a physician with one of the primary specialty designations included in § 425.402(c) (see § 425.402(e)). Such beneficiaries will be added prospectively to the ACO's list of assigned beneficiaries for the subsequent performance year, superseding any assignment that might have otherwise occurred under the claims-based methodology. Further, beneficiaries may change their designation at any time through
Section 1899(c) of the Act, as amended by section 50331 of the Bipartisan Budget Act of 2018, requires the Secretary to permit a Medicare FFS beneficiary to voluntarily identify an ACO professional as their primary care provider for purposes of assignment to an ACO. Under our current methodology, a beneficiary may select any practitioner who has a record on the Physician Compare website as their primary clinician; however, we will only assign the beneficiary to an ACO if they have chosen a practitioner who is a primary care physician (as defined at § 425.20), a physician with one of the primary specialty designations included in § 425.402(c), or a nurse practitioner, physician assistant, or clinical nurse specialist. Therefore, we proposed to modify our current voluntary alignment policies at § 425.402(e)(2)(iii) to provide that we will assign a beneficiary to an ACO based upon their selection of any ACO professional, regardless of specialty, as their primary clinician. Under this proposal, a beneficiary may select a practitioner with any specialty designation, for example, a specialty of allergy/immunology or surgery, as their primary care provider and be eligible for assignment to the ACO in which the practitioner is an ACO professional. Specifically, we proposed to revise § 425.402(e)(2)(iii) to remove the requirement that the ACO professional designated by the beneficiary be a primary care physician as defined at § 425.20, a physician with a specialty designation included at § 425.402(c), or a nurse practitioner, physician assistant, or clinical nurse specialist. In addition, the provision at § 425.402(e)(2)(iv) addresses beneficiary designations of clinicians outside the ACO as their primary clinician. The current policy at § 425.402(e)(2)(iv) provides that a beneficiary will not be assigned to an ACO for a performance year if the beneficiary has designated a provider or supplier outside the ACO who is a primary care physician as defined at § 425.20, a physician with a specialty designation included at § 425.402(c), or a nurse practitioner, physician assistant, or clinical nurse specialist as their primary clinician responsible for coordinating their overall care. Consistent with the proposed revisions to § 425.402(e)(2)(iii) to incorporate the requirements of section 50331 of the Bipartisan Budget Act, we proposed to revise § 425.402(e)(2)(iv) to indicate that if a beneficiary designates any provider or supplier outside the ACO as their primary clinician responsible for coordinating their overall care, the beneficiary will not be added to the ACO's list of assigned beneficiaries for a performance year.
Section 1899(c) of the Act, as amended by section 50331 of the Bipartisan Budget Act of 2018, requires the Secretary to allow a beneficiary to voluntarily align with an ACO, and does not impose any restriction with respect to whether the beneficiary has received any services from an ACO professional (see section 1899(c)(2)(B)(i) of the Act). As we explained in the August 2018 proposed rule (83 FR 41895), we believe the requirement in section 1899(c)(2)(B)(iii) of the Act that a beneficiary's voluntary identification shall supersede any claims-based alignment is also consistent with eliminating the requirement that the beneficiary have received a service from an ACO professional in order to be eligible to be assigned an ACO. Therefore, we proposed to remove the requirement at § 425.402(e)(2)(i) that a beneficiary must have received at least one primary care service from an ACO professional who is either a primary care physician or a physician with a specialty designation included in § 425.402(c) within the 12-month assignment window in order to be assigned to the ACO. Under this proposal, a beneficiary who selects a primary clinician who is an ACO professional, but who does not receive any services from an ACO participant during the assignment window, will remain eligible for assignment to the ACO. We stated that we believe this approach would reduce burden on beneficiaries and their practitioners by not requiring practitioners to provide unnecessary care during a specified period of time in order for a beneficiary to remain eligible for assignment to the ACO. Consistent with this proposal, we proposed to remove § 425.402(e)(2)(i) in its entirety.
We noted that, under this proposal, if a beneficiary does not change their primary clinician designation, the beneficiary will remain assigned to the ACO in which that practitioner participates during the ACO's entire agreement period and any subsequent agreement periods under the Shared Savings Program, even if the beneficiary no longer seeks care from any ACO professionals. Because a beneficiary who has voluntarily identified a Shared Savings Program ACO professional as their primary care provider will remain assigned to the ACO regardless of where they seek care, this proposed change could also impact assignment under certain Innovation Center models in which overlapping beneficiary assignment is not permitted. As we explained in the August 2018 proposed rule (83 FR 41895), we believe our proposed policy is consistent with the requirement under section 1899(c)(2)(B)(iii) of the Act that a voluntary identification by a beneficiary shall supersede any claims-based assignment. However, we also believe it could be appropriate, in limited circumstances, to align a beneficiary to an entity participating in certain specialty and disease-specific Innovation Center models, such as the Comprehensive ESRD Care (CEC) Model. CMS implemented the CEC Model to test a new system of payment and service delivery that CMS believes will lead to better health outcomes for Medicare beneficiaries living with ESRD, while lowering costs to Medicare Parts A and B. Under the model, CMS is working with groups of health care providers, dialysis facilities, and other suppliers involved in the care of ESRD beneficiaries to improve the coordination and quality of care that these individuals receive. We believe that an ESRD beneficiary, who is otherwise eligible for assignment to an entity participating in the CEC Model, could benefit from the focused attention on and increased care coordination for their ESRD available under the CEC Model. Such a beneficiary could be disadvantaged if they were unable to receive the type of specialized care for their ESRD that will be available from an entity participating in the CEC Model. Furthermore, we believe it could be difficult for the Innovation Center to conduct a viable test of a specialty or disease-specific model, if we were to require that beneficiaries who have previously designated an ACO professional as their primary clinician remain assigned to the Shared Savings Program ACO under all circumstances. Currently, the CEC Model completes its annual PY prospective assignment lists prior to the Shared Savings Program in order to identify the beneficiaries who may benefit from receiving specialized care from an entity participating in the CEC Model. Additionally, on a quarterly basis, a beneficiary may be assigned to the CEC Model who was previously assigned to a Track 1 or Track 2 ACO.
As a result, we believe that in some instances it may be necessary for the Innovation Center to use its authority under section 1115A(d)(1) of the Act to waive the requirements of section 1899(c)(2)(B) of the Act solely as necessary for purposes of testing a particular model. Therefore, we proposed to create an exception to the general policy that a beneficiary who has voluntarily identified a Shared Savings Program ACO professional as their primary care provider will remain assigned to the ACO regardless of where they seek care. Specifically, we proposed that we would not assign such a beneficiary to the ACO when the beneficiary is also eligible for assignment to an entity participating in a model tested or expanded under section 1115A of the Act under which claims-based assignment is based solely on claims for services other than primary care services and for which there has been a determination by the Secretary that a waiver under section 1115A(d)(1) of the Act of the requirement in section 1899(c)(2)(B) of the Act is necessary solely for purposes of testing the model. Under this proposal, if a beneficiary selects a primary clinician who is a Shared Savings Program ACO professional and the beneficiary is also eligible for alignment to a specialty care or disease specific model tested or expanded under section 1115A of the Act under which claims-based assignment is based solely on claims for services other than primary care services and for which there has been a determination that a waiver of the requirement in section 1899(c)(2)(B) is necessary solely for purposes of testing the Model, the Innovation Center or its designee would notify the beneficiary of their alignment to an entity participating in the model. Additionally, although such a beneficiary may still voluntarily identify his or her primary clinician and may seek care from any clinician, the beneficiary would not be assigned to a Shared Savings Program ACO even if the designated primary clinician is an ACO professional in a Shared Savings Program ACO.
In the August 2019 proposed rule (83 FR 41896), we indicated that we would include a list of any models that meet these criteria on the Shared Savings Program website, to supplement the information already included in the beneficiary assignment reports we currently provide to ACOs (as described under § 425.702(c)), so that ACOs can know why certain beneficiaries, who may have designated an ACO professional as their primary clinician, are not assigned to them. Similar information would also be shared with 1-800-MEDICARE to ensure that Medicare customer service representatives are able to help beneficiaries who may be confused as to why they are not aligned to the ACO in which their primary clinician is participating.
Section 1899(c)(2)(B)(ii) of the Act, as amended by section 50331 of the Bipartisan Budget Act, requires the Secretary to establish a process under the Shared Savings Program through which each Medicare FFS beneficiary is notified of the ability to identify an ACO professional as his or her primary care provider and informed of the process that may be used to make and change such identification. In the August 2018 proposed rule (83 FR 41896), we stated our intent to implement section 1899(c)(2)(B)(ii) of the Act under the beneficiary notification process at § 425.312. We are not addressing this topic at this time. We will summarize and respond to public comments on this proposed policy in a forthcoming final rule.
We proposed to apply these modifications to our policies under the Shared Savings Program regarding voluntary alignment beginning for performance years starting on January 1, 2019, and subsequent performance years. We proposed to incorporate these new requirements in the regulations by redesignating § 425.402(e)(2)(i) through (iv) as § 425.402(e)(2)(i)(A) through (D), adding a paragraph heading for newly redesignated § 425.402(e)(2)(i), and including a new § 425.402(e)(2)(ii).
We noted that as specified in § 425.402(e)(2)(ii) a beneficiary who has designated an ACO professional as their primary clinician must still be eligible for assignment to an ACO by meeting the criteria specified in § 425.401(a). These criteria establish the minimum requirements for a beneficiary to be eligible to be assigned to an ACO under our existing assignment methodology, and we believe it is appropriate to impose the same basic limitations on the assignment of beneficiaries on the basis of voluntary alignment. We do not believe it would be appropriate, for example, to assign a beneficiary to an ACO if the beneficiary does not reside in the United States, or if the other eligibility requirements are not met.
We requested comments on our proposals to implement the new requirements governing voluntary alignment under section 50331 of the Bipartisan Budget Act of 2018. We also sought comment on our proposal to create a limited exception to our proposed policies on voluntary alignment to allow a beneficiary to be assigned to an entity participating in a model tested or expanded under section 1115A of the Act when certain criteria are met. In addition, we welcomed comments on how we might increase beneficiary awareness and further improve the electronic process through which a beneficiary may voluntarily identify an ACO professional as their primary care provider through
We did not receive any public comments on the proposal not to voluntarily align a beneficiary to the ACO in which their primary clinician participates when the beneficiary is also eligible for assignment to an entity participating in a model tested or expanded under section 1115A of the Act under which claims-based assignment is based solely on claims for services other than primary care services (for example, CEC).
After considering the comments received in response to the proposals to revise the voluntary alignment methodology, we are finalizing the policies as proposed. Specifically, we are finalizing the policy to assign a beneficiary to an ACO based upon their selection of any ACO professional, regardless of specialty, as their primary clinician. We are also finalizing our proposal to remove the requirement that a beneficiary must have received at least one primary care service from an ACO professional who is either a primary care physician or a physician with a specialty designation included in § 425.402(c) within the 12-month assignment window in order to be assigned to the ACO. Lastly, we are finalizing a policy not to voluntarily align a beneficiary to an ACO when the beneficiary is also eligible for assignment to an entity participating in a model tested or expanded under section 1115A of the Act under which claims-based assignment is based solely on claims for services other than primary care services. Accordingly, we are also finalizing the proposed revisions to § 425.402(e)(2) without modification.
Section 1899(c)(1) of the Act, as amended by the 21st Century Cures Act and the Bipartisan Budget Act of 2018, provides that for performance years beginning on or after January 1, 2019, the Secretary shall assign beneficiaries to an ACO based on their utilization of primary care services provided by a physician and all services furnished by RHCs and FQHCs. However, the statute does not specify which kinds of services may be considered primary care services for purposes of beneficiary assignment. We established the initial list of services that we considered to be primary care services in the November 2011 final rule (76 FR 67853). In that final rule, we indicated that we intended to monitor this issue and would consider making changes to the definition of primary care services to add or delete codes used to identify primary care services, if there were sufficient evidence that revisions were warranted. We have updated the list of primary care service codes in subsequent rulemaking to reflect additions or modifications to the codes that have been recognized for payment under the Medicare PFS, as summarized in the CY 2018 PFS proposed rule (82 FR 34109 and 34110). Subsequently, in the CY 2018 PFS final rule, we revised the definition of primary care services to include three additional chronic care management service codes, 99487, 99489, and G0506, and four behavioral health integration service codes, G0502, G0503, G0504 and G0507 (82 FR 53212 and 53213). These additions are effective for purposes of performing beneficiary assignment under § 425.402 for performance year 2019 and subsequent performance years.
Accounting for these recent changes, we define primary care services in § 425.400(c) for purposes of assigning beneficiaries to ACOs under § 425.402 as the set of services identified by the following HCPCS/CPT codes:
(1) 99201 through 99215 (codes for office or other outpatient visit for the evaluation and management of a patient).
(2) 99304 through 99318 (codes for professional services furnished in a Nursing Facility, excluding services furnished in a SNF which are reported on claims with place of service code 31).
(3) 99319 through 99340 (codes for patient domiciliary, rest home, or custodial care visit).
(4) 99341 through 99350 (codes for evaluation and management services furnished in a patients' home).
(5) 99487, 99489 and 99490 (codes for chronic care management).
(6) 99495 and 99496 (codes for transitional care management services).
(1) G0402 (the code for the Welcome to Medicare visit).
(2) G0438 and G0439 (codes for the Annual Wellness Visits).
(3) G0463 (code for services furnished in electing teaching amendment hospitals).
(4) G0506 (code for chronic care management).
(5) G0502, G0503, G0504 and G0507 (codes for behavioral health integration).
As discussed in the CY 2018 PFS final rule (82 FR 53213), a commenter recommended that CMS consider including the advance care planning codes, CPT codes 99497 and 99498, in the definition of primary care services in future rulemaking. We indicated that we would consider whether CPT codes 99497 and 99498 or any additional existing HCPCS/CPT codes should be added to the definition of primary care services in future rulemaking for purposes of assignment of beneficiaries to ACOs under the Shared Savings Program. In addition, effective for CY 2018, the HCPCS codes for behavioral health integration G0502, G0503, G0504 and G0507 have been replaced by CPT codes 99492, 99493, 99494, 99484 (82 FR 53078).
CPT codes 99304 through 99318 are used for reporting evaluation and management (E&M) services furnished by physicians and other practitioners in a SNF (reported on claims with POS code 31) or a nursing facility (reported on claims with POS code 32). Based on stakeholder input, we finalized a policy in the CY 2016 PFS final rule (80 FR 71271 through 71272) effective for performance year 2017 and subsequent performance years, to exclude services identified by CPT codes 99304 through 99318 from the definition of primary care services for purposes of the beneficiary assignment methodology when the claim includes the POS code 31 modifier designating the services as having been furnished in a SNF. We established this policy to recognize that SNF patients are shorter stay patients who are generally receiving continued acute medical care and rehabilitative services. Although their care may be coordinated during their time in the SNF, they are then transitioned back into the community to the primary care professionals who are typically responsible for providing care to meet their true primary care needs. We
In the August 2018 proposed rule (83 FR 41897 through 41899), we proposed to make changes to the definition of primary care services in § 425.400(c) to add new codes and to revise how we determine whether services identified by CPT codes 99304 through 99318 were furnished in a SNF.
Based on feedback from ACOs and our further review of the HCPCS and CPT codes currently recognized for payment under the PFS, we believe it would be appropriate to amend the definition of primary care services to include certain additional codes. Specifically, we proposed to revise the definition of primary care services in § 425.400(c) to include the following HCPCS and CPT codes: (1) Advance care planning service codes; CPT codes 99497 and 99498; (2) administration of health risk assessment service codes; CPT codes 96160 and 96161; (3) prolonged evaluation and management or psychotherapy service(s) beyond the typical service time of the primary procedure, CPT codes 99354 and 99355; (4) annual depression screening service code, HCPCS code G0444; (5) alcohol misuse screening service code, HCPCS code G0442; and (6) alcohol misuse counseling service code, HCPCS code G0443. In addition, in the CY 2019 PFS proposed rule (see 83 FR 35841 through 35844), CMS proposed to create three new HCPCS codes to reflect the additional resources involved in furnishing certain evaluation and management services: (1) GPC1X add-on code, for the visit complexity inherent to evaluation and management associated with certain primary care services, (2) GCG0X add-on code, for visit complexity inherent to evaluation and management associated with endocrinology, rheumatology, hematology/oncology, urology, neurology, obstetrics/gynecology, allergy/immunology, otolaryngology, or interventional pain management-centered care, and (3) GPRO1, an additional add-on code for prolonged evaluation and management or psychotherapy services beyond the typical service time of the primary procedure. As we explained in the August 2018 proposed rule (83 FR 41897), we believe it would be appropriate to include these codes in the definition of primary care services under the Shared Savings Program because these codes are used to bill for services that are similar to services that are already included in the list of primary care codes at § 425.400(c). We also expect that primary care physicians, nurse practitioners, physician assistants, and clinical nurse specialists frequently furnish these services as part of their overall management of a patient. As a result, we believe that including these codes would increase the accuracy of the assignment process by helping to ensure that beneficiaries are assigned to the ACO or other entity that is actually managing the beneficiary's care.
The following provides additional information about the HCPCS and CPT codes that we proposed to add to the definition of primary care services:
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In the CY 2019 PFS proposed rule (see 83 FR 35841 through 35844), we proposed to create three new HCPCS G-codes as part of a broader proposal to simplify the documentation requirements and to more accurately pay for services represented by CPT codes 99201 through 99215 (codes for office or other outpatient visit for the evaluation and management of a patient). All three of these codes are “add-on codes” that describe additional resource components of a broader service furnished to the patient that are not accounted for in the valuation of the base codes.
HCPCS code GPC1X is intended to capture the additional resource costs, beyond those involved in the base evaluation and management codes, of providing face-to-face primary care services for established patients. HCPCS code GPC1X would be billed in addition to the base evaluation and management code for an established patient when the visit includes primary care services. In contrast, new HCPCS code GCG0X is an add-on code intended to reflect the complexity inherent to evaluation and management services associated with endocrinology, rheumatology, hematology/oncology, urology, neurology, obstetrics/gynecology, allergy/immunology, otolaryngology, cardiology, and interventional pain management-centered care. As we stated in the August 2018 proposed rule (83 FR 41899), we believe it would be appropriate to include both proposed new HCPCS codes GCG0X and GPC1X in our definition of primary care services because they represent services that are currently included in CPT codes 99201 through 99215, which are already included in the list of primary care codes in § 425.400(c).
Finally, proposed new HCPCS code GPRO1 (prolonged evaluation and management or psychotherapy services beyond the typical service time of the primary procedure, in the office or other outpatient setting requiring direct patient contact beyond the usual service; 30 minutes) is modeled on CPT code 99354, a prolonged services code discussed earlier in this section which we proposed to add to our list of primary care services. HCPCS code GPRO1 is intended to reflect prolonged evaluation and management or psychotherapy service(s) of 30 minutes duration beyond the typical service time of the primary or base service, whereas existing CPT code 99354 reflects prolonged services of 60 minutes duration. As is the case for code 99354, code GPRO1 would be billed separately in addition to the base office or other outpatient evaluation and management or psychotherapy service. We stated that we believe it would be appropriate to include proposed HCPCS code GPRO1 on our list of primary care services for the same reasons we proposed to add CPT code 99354 to our list of primary care services. Because the proposed definition of HCPCS code GPRO1 also includes prolonged services for certain psychotherapy services, which are not currently included on our list of primary care services, we proposed to include the allowed charges for HCPCS code GPRO1, for purposes of assigning beneficiaries to ACOs, only when the base code is also on the list of primary care services.
We proposed to include these codes in the definition of primary care services when performing beneficiary assignment under § 425.402, for performance years starting on January 1, 2019, and subsequent years. However, we noted that our proposal to include the three proposed new “add-on codes”, GPC1X, GCG0X, and GPRO1, was contingent on CMS finalizing its proposal to create these new codes for use starting in 2019.
As discussed in section V.B.2.c.(1) of this final rule, ACOs and other commenters have expressed concerns regarding our current policy of identifying services billed under CPT codes 99304 through 99318 furnished in a SNF by using the POS modifier 31. We continue to believe it is appropriate to exclude from assignment services billed under CPT codes 99304 through 99318 when such services are furnished in a SNF. However, as we explained in the August 2018 proposed rule (83 FR 41899), we agree with commenters that it might increase the accuracy of beneficiary assignment for these vulnerable and generally high cost beneficiaries if we were to revise our method for determining whether services identified by CPT codes 99304 through 99318 were furnished in a SNF to focus on whether the beneficiary also received SNF facility services on the same day. We believe it would be feasible for us to directly and more precisely determine whether services identified by CPT codes 99304 through
Under our current process, if CMS' HCPCS committee or the American Medical Association's CPT Editorial Panel modifies or replaces any of the codes that we designate as primary care service codes in § 425.400(c), we must revise the primary care service codes listed in § 425.400(c) as appropriate through further rulemaking before the revised codes can be used for purposes of assignment. As noted previously, effective for CY 2018, the HCPCS codes for behavioral health integration G0502, G0503, G0504 and G0507 have been replaced by CPT codes 99492, 99493, 99494 and 99484. Therefore, consistent with our current process, we proposed to revise the primary care service codes in § 425.400(c)(1)(iv) to replace HCPCS codes G0502, G0503, G0504 and G0507 with CPT codes 99492, 99493, 99494 and 99484 for performance years starting on January 1, 2019, and subsequent performance years.
We also noted that the regulations text at § 425.400(c)(1)(iv) includes brief descriptions for the HCPCS codes that we have designated as primary care service codes, but does not include such descriptions for the CPT codes that we have designated as primary care service codes. For consistency, we proposed a technical change to the regulations at § 425.400(c)(1)(iv)(A) to also include descriptions for the CPT codes. We also noted that one of the Chronic Care Management (CCM) codes, CPT code 99490, is inadvertently listed in the regulations text at § 425.400(c)(1)(iv)(A)(
We welcomed comments on the new codes we proposed to add to the definition of primary care services used for purposes of assigning beneficiaries to Shared Savings Program ACOs. In addition, we sought comment on our proposal to revise our method for excluding services identified by CPT codes 99304 through 99318 when furnished in a SNF. We also sought comment on the other proposed technical changes to § 425.400(c)(1)(iv). We also welcomed comments on any additional existing HCPCS/CPT codes that we should consider adding to the definition of primary care services in future rulemaking.
As discussed earlier in this final rule, the proposal to create three new HCPCS G-codes as part of a broader proposal to simplify the documentation requirements and to more accurately pay for the office or other outpatient evaluation and management services represented by CPT codes 99201 through 99215 is not being finalized. Therefore, the proposal to include HCPCS “add-on codes”, GPC1X, GCG0X, and GPRO1 in the definition of “primary care services” will not be finalized at this time. We will revisit this proposal in future rulemaking and continue to monitor the annual rulemaking for the PFS to determine if we should propose any changes to the definition of primary care services for the Shared Savings Program to reflect proposed HCPCS/CPT coding changes.
We received no comments on the proposed technical changes to § 425.400(c)(1)(iv). After considering the comments received, we are finalizing our proposed revisions to the definition of primary care services, with the exception of the proposal to include the three add-on HCPCS codes GPC1X, GCG0X, and GPRO1. Specifically, we are revising the definition of primary care services in § 425.400(c) to add CPT codes 99497, 99498, 96160, 96161, 99354, and 99355, and HCPCS codes G0444, G0442, and G0443. Additionally, we are finalizing, as proposed, the revisions to our method for excluding services identified by CPT codes 99304 through 99318 when furnished in a SNF and the proposed technical changes to § 425.400(c)(1)(iv).
Consistent with the approach we have taken in the past when implementing changes to the assignment methodology, we will adjust ACOs' historical benchmarks for the performance year starting on January 1, 2019, to account for the changes to the assignment methodology that we are finalizing in this final rule.
Following the 2017 California wildfires and Hurricanes Harvey, Irma, Maria, and Nate, stakeholders expressed concerns that the effects of these types of disasters on ACO participants, ACO providers/suppliers, and the assigned beneficiary population could undermine an ACO's ability to successfully meet the quality performance standards, and adversely affect financial performance, including, in the case of ACOs under performance-based risk, increasing shared losses. To address these concerns, we published an interim final rule with comment period titled Medicare Program; Medicare Shared Savings Program: Extreme and Uncontrollable Circumstances Policies for Performance Year 2017 (hereinafter referred to as the Shared Savings Program IFC) that appeared in the December 26, 2017
The extreme and uncontrollable circumstances policies established in the Shared Savings Program for performance year 2017 align with the policies established under the Quality Payment Program for the 2017 MIPS performance period and subsequent MIPS performance periods (see CY 2018 Quality Payment Program final rule with comment, 82 FR 53780 through 53783 and Quality Payment Program IFC, 82 FR 53895 through 53900). In particular, in the Shared Savings Program IFC (82 FR 60914), we indicated that we would determine whether an ACO had been affected by an extreme and uncontrollable circumstance by determining whether 20 percent or more of the ACO's assigned beneficiaries resided in counties designated as an emergency declared area in performance year 2017 as determined under the Quality Payment Program or the ACO's legal entity was located in such an area. In the Quality Payment Program IFC (82 FR 53897), we explained that we anticipated that the types of events that could trigger the extreme and uncontrollable circumstances policies would be events designated a Federal Emergency Management Agency (FEMA) major disaster or a public health emergency declared by the Secretary, although we indicated that we would review each situation on a case-by-case basis.
Because ACOs may face extreme and uncontrollable circumstances in 2018 and subsequent years, we proposed to extend the policies adopted in the Shared Savings Program IFC for addressing ACO quality performance scoring and the determination of the shared losses owed for ACOs affected by extreme or uncontrollable circumstances to performance year 2018 and subsequent performance years. In addition, in the Shared Savings Program IFC, we indicated that we planned to observe the impact of the 2017 hurricanes and wildfires on ACOs' expenditures for their assigned beneficiaries during performance year 2017, and might revisit the need to make adjustments to the methodology for calculating the benchmark in future rulemaking. We considered this issue further in the August 2018 proposed rule (see 83 FR 41904 through 41906).
The financial and quality performance of ACOs located in areas subject to extreme and uncontrollable circumstances could be significantly and adversely affected. Disasters may have several possible effects on ACO quality and financial performance. For instance, displacement of beneficiaries may make it difficult for ACOs to access medical record data required for quality
As we stated in the August 2018 proposed rule (83 FR 41900), because widespread disruptions could occur during 2018 or subsequent performance years, we believe it is appropriate to have policies in place to change the way in which we assess the quality and financial performance of Shared Savings Program ACOs in any affected areas. Accordingly, we proposed to extend the automatic extreme and uncontrollable circumstances policies under the Shared Savings Program that were established for performance year 2017 to performance year 2018 and subsequent performance years. Specifically, we proposed that the Shared Savings Program extreme and uncontrollable circumstances policies for performance year 2018 and subsequent performance years would apply when we determine that an event qualifies as an automatic triggering event under the Quality Payment Program. As we discussed in the Shared Savings Program IFC (82 FR 60914), we believe it is also appropriate to extend these policies to encompass the quality reporting period, unless the reporting period is extended, because if an ACO is unable to submit its quality data as a result of a disaster occurring during the quality data submission window, we would not have the quality data necessary to measure the ACO's quality performance for the performance year. For example, if an extreme and uncontrollable event were to occur in February 2019, which we anticipate would be during the quality data reporting period for performance year 2018, then the extreme and uncontrollable circumstances policies would apply for quality data reporting and quality performance scoring for performance year 2018, if the reporting period is not extended. We explained that we do not believe it is appropriate to extend this policy to encompass the quality data reporting period if the reporting period is extended because affected ACOs would have an additional opportunity to submit their quality data, enabling us to measure their quality performance in the applicable performance year. Accordingly, we also proposed that the policies regarding quality reporting would apply with respect to the determination of the ACO's quality performance in the event that an extreme and uncontrollable event occurs during the applicable quality data reporting period for a performance year and the reporting period is not extended. However, we noted that, because a disaster that occurs after the end of the performance year would have no impact on the determination of an ACO's financial performance for that performance year, it would not be appropriate to make an adjustment to shared losses in the event an extreme or uncontrollable event occurs during the quality data reporting period.
As we explained in the Shared Savings Program IFC (82 FR 60914 through 60916), ACOs and their ACO participants and ACO providers/suppliers are frequently located across several different geographic regions or localities, serving a mix of beneficiaries who may be differentially impacted by hurricanes, wildfires, or other triggering events. Therefore, for 2017, we established a policy for determining when an ACO, which may have ACO participants and ACO providers/suppliers located in multiple geographic areas, would qualify for the automatic extreme and uncontrollable circumstance policies for the determination of quality performance. Specifically, we adopted a policy for performance year 2017 of determining whether an ACO had been affected by extreme and uncontrollable circumstances by determining whether 20 percent or more of the ACO's assigned beneficiaries resided in counties designated as an emergency declared area in the performance year, as determined under the Quality Payment Program as discussed in the Quality Payment Program IFC (82 FR 53898) or the ACO's legal entity was located in such an area. For 2017, we adopted a policy under which the location of an ACO's legal entity was determined based on the address on file for the ACO in CMS' ACO application and management system. We used 20 percent of the ACO's assigned beneficiary population as the minimum threshold to establish an ACO's eligibility for the policies regarding quality reporting and quality
The 20 percent threshold was selected to account for the effect of an extreme or uncontrollable circumstance on an ACO that has the minimum number of assigned beneficiaries to be eligible for the program (5,000 beneficiaries), and in consideration of the average total number of unique beneficiaries for whom quality information is required to be reported in the combined CAHPS survey sample (860 beneficiaries) and the CMS Web Interface sample (approximately 3,500 beneficiaries). (There may be some overlap between the CAHPS sample and the CMS Web Interface sample.) Therefore, we estimated that an ACO with an assigned population of 5,000 beneficiaries typically would be required to report quality information on a total of 4,000 beneficiaries. Thus, we indicated that we believe the 20 percent threshold ensures that an ACO with the minimum number of assigned beneficiaries would have an adequate number of beneficiaries across the CAHPS and CMS Web Interface samples in order to fully report on these measures. However, we also noted that it is possible that some ACOs that have fewer than 20 percent of their assigned beneficiaries residing in affected areas may have a legal entity that is located in an emergency declared area. Consequently, their ability to quality report may be equally impacted because the ACO legal entity may be unable to collect the necessary information from their ACO participants or may experience infrastructure issues related to capturing, organizing, and reporting the data to CMS. We stated that if less than 20 percent of the ACO's assigned beneficiaries reside in an affected area and the ACO's legal entity is not located in a county designated as an affected area, then we believe that there is unlikely to be a significant impact upon the ACO's ability to report or on the representativeness of the quality performance score that is determined for the ACO. For performance year 2017, we determined what percentage of the ACO's performance year assigned population was affected by a disaster based on the final list of beneficiaries assigned to the ACO for the performance year. Although beneficiaries are assigned to ACOs under Track 1 and Track 2 based on preliminary prospective assignment with retrospective reconciliation after the end of the performance year, these ACOs were able to use their quarterly assignment lists, which include beneficiaries' counties of residence, for early insight into whether they were likely to meet the 20 percent threshold.
In the Shared Savings Program IFC, we modified the quality performance standard specified under § 425.502 by adding a new paragraph (f) to address potential adjustments to the quality performance scores for performance year 2017 of ACOs determined to be affected by extreme and uncontrollable circumstances. We also modified § 425.502(e)(4) to specify that an ACO receiving the mean Shared Savings Program ACO quality score for performance year 2017 based on the extreme and uncontrollable circumstances policies would not be eligible for bonus points awarded based on quality improvement in that year because quality data would not be available to determine if there was improvement from year to year.
In the Shared Savings Program IFC, we established policies with respect to quality reporting and quality performance scoring for the 2017 performance year. In anticipation of any future extreme and uncontrollable events, in the August 2018 proposed rule (83 FR 41901) we proposed to extend these policies, with minor modifications, to subsequent performance years as well. In order to avoid confusion and reduce unnecessary burdens on affected ACOs, we proposed to align our policies for 2018 and subsequent years with policies established for the Quality Payment Program in the final rule with comment period, entitled CY 2018 Updates to the Quality Payment Program (82 FR 53568). Specifically, we proposed to apply determinations made under the Quality Payment Program with respect to whether an extreme and uncontrollable circumstance has occurred and the identification of the affected geographic areas and the applicable time periods. Generally, in line with the approach taken for 2017 in the Quality Payment Program IFC (82 FR 53897), we anticipated that the types of events that would be considered an automatic triggering event would be events designated as a Federal Emergency Management Agency (FEMA) major disaster or a public health emergency declared by the Secretary, but indicated that CMS would review each situation on a case-by-case basis. We also proposed that CMS would have sole discretion to determine the time period during which an extreme and uncontrollable circumstance occurred, the percentage of the ACO's assigned beneficiaries residing in the affected areas, and the location of the ACO legal entity. Additionally, we proposed to determine an ACO's legal entity location based on the address on file for the ACO in CMS' ACO application and management system.
In the Shared Savings Program IFC, we established a policy for performance year 2017 under which we determined the percentage of the ACO's assigned population that was affected by a disaster based on the final list of beneficiaries assigned to the ACO for the performance year. We begin producing the final list of assigned beneficiaries after allowing for 3 months of claims run out following the end of a performance year. However, the quality reporting period ends before the 3-month claims run out period ends. Therefore, in the August 2018 proposed rule we expressed concern that if, for future performance years, we continue to calculate the percentage of affected beneficiaries based on the ACO's final list of assigned beneficiaries, it would not be operationally feasible for us to notify an ACO as to whether it meets the 20 percent threshold prior to the end of the quality reporting period because the final list of assigned beneficiaries is not available until after the close of the quality reporting period. We explained that we now believe it would be appropriate to base this calculation on the list of assigned beneficiaries used to generate the Web Interface quality reporting sample, which would be available with the quarter three program reports, generally in November of the applicable performance year. We also indicated this report would be available to ACOs participating in the proposed 6-month performance year from January 1, 2019 through June 30, 2019. By basing the calculation on the list of assigned beneficiaries used to generate the Web Interface quality reporting sample, we would be able to notify ACOs earlier as to whether they exceed the 20 percent threshold, and ACOs could then use this information to decide whether to report quality data for the performance year. Therefore, for performance year 2018 and subsequent performance years, we proposed to determine the percentage of an ACO's assigned beneficiaries that reside in an area affected by an extreme and uncontrollable circumstance using the list of assigned beneficiaries used to generate the Web Interface quality reporting sample. We indicated that we
In the Shared Savings Program IFC (82 FR 60916), we described the policies under the MIPS APM scoring standard that would apply for performance year 2017 for MIPS eligible clinicians in an ACO that did not completely report quality. The existing tracks of the Shared Savings Program (Track 1, Track 2 and Track 3), and the Track 1+ Model are all MIPS APMs under the APM scoring standard.
We proposed to revise § 425.502(f) to extend the policies established for performance year 2017 to performance year 2018 and subsequent performance years. Specifically, we proposed that for performance year 2018 and subsequent performance years, including the applicable quality data reporting period for the performance year if the reporting period is not extended, in the event that we determine that 20 percent or more of an ACO's assigned beneficiaries, as determined using the list of beneficiaries used to generate the Web Interface quality reporting sample, reside in an area that is affected by an extreme and uncontrollable circumstance, as determined under the Quality Payment Program, or that the ACO's legal entity is located in such an area, we would use the following approach to calculate the ACO's quality performance score as specified in proposed revisions to paragraphs (e) and (f) of § 425.502.
• The ACO's minimum quality score would be set to equal the mean quality performance score for all Shared Savings Program ACOs for the applicable performance year.
• If the ACO is able to completely and accurately report all quality measures, we would use the higher of the ACO's quality performance score or the mean quality performance score for all Shared Savings Program ACOs. If the ACO's quality performance score is used, the ACO would also be eligible for quality improvement points.
• If the ACO receives the mean Shared Savings Program quality performance score, the ACO would not be eligible for bonus points awarded based on quality improvement during the applicable performance year.
• If an ACO receives the mean Shared Savings Program ACO quality performance score for a performance year, in the next performance year for which the ACO reports quality data and receives a quality performance score based on its own performance, we would measure quality improvement based on a comparison between the ACO's performance in that year and in the most recently available prior performance year in which the ACO reported quality. Under this approach, the comparison would continue to be between consecutive years of quality reporting, but these years may not be consecutive calendar years.
Additionally, we proposed to address the possibility that ACOs that have a 6-month performance year (or performance period) during 2019 may be affected by extreme and uncontrollable circumstances. In this final rule, we are addressing the proposals specific to the 6-month performance year from January 1, 2019 through June 30, 2019. In a forthcoming final rule, we anticipate discussing comments received on the proposals related to policies for the 6-month performance year from July 1, 2019 through December 31, 2019, and the performance period from January 1, 2019 through June 30, 2019, for ACOs that terminate their agreement effective June 30, 2019, and enter a new agreement period starting on July 1, 2019. We anticipate this discussion will include a description of the applicability of policies for addressing extreme and uncontrollable circumstances.
As described in section II.A.7 of the August 2018 proposed rule, we proposed to use 12 months of data, based on the calendar year, to determine quality performance for the 6-month performance year from January 2019 through June 2019 (83 FR 41856 through 41858). We explained our belief that it is necessary to account for disasters occurring in any month(s) of CY 2019 for ACOs participating in a 6-month performance year during 2019 regardless of whether the ACO is actively participating in the Shared Savings Program at the time of the disaster. Therefore, for ACOs with a 6-month performance year from January 1, 2019 through June 30, 2019, affected by a disaster in any month of 2019, we would use the alternative scoring methodology specified in § 425.502(f) to determine the quality performance score for the 2019 quality reporting period, if the reporting period is not extended. For example, assume that an ACO participates in the Shared Savings Program for a 6-month performance year from January 1, 2019 through June 30, 2019, and does not continue its participation in the program for a new agreement period beginning July 1, 2019 (as proposed). Further assume that we determine that 20 percent or more of the ACO's assigned beneficiaries, as determined using the list of beneficiaries used to generate the Web Interface quality reporting sample, reside in an area that is affected by an extreme and uncontrollable circumstance, as determined under the
We proposed to specify the applicability of the alternative scoring methodology in § 425.502(f) for the 6-month performance year from January 1, 2019 through June 30, 2019, in the proposed new section of the regulations at § 425.609(d).
We solicited comments on the proposed policies for assessing the quality performance of ACOs affected by an extreme or uncontrollable circumstance during performance year 2018 and subsequent years, including the applicable quality data reporting period for the performance year, unless the reporting period is extended.
Commenters offered various suggestions on how to implement a policy that considers an ACO's historic quality performance. A few commenters recommended that CMS use the highest of the ACO's quality score for the affected performance year, the ACO's quality score for the prior performance year (if available), or the national mean quality score. One commenter recommended following this approach for each individual quality measure. Suggestions from other commenters included: Using the higher of the ACO's average quality score for the prior two years and the national mean for ACOs in their third or subsequent year in the program and using the national average score for ACOs in their first or second year in the program; Using the higher of the affected year quality score and the prior year quality score, if one is available, and otherwise using the higher of the affected year score and the national mean score; Using the ACO's historical quality performance instead of the mean when an ACO is in its third or subsequent performance year in the program.
Several commenters also recommended that the proposed policies in this section be extended to include all ACOs affected by a natural disaster, not just those that cannot report quality data. A few commenters provided suggestive evidence that quality outcome measures such as readmission measures may be subject to immediate and significant impacts in the event of a natural disaster, which could have an adverse impact on an ACO's quality score, particularly given the non-linear nature of the program's quality scoring methodology under which an ACO receives zero points on a measure if it falls below the 30th percentile. Several commenters requested that that those ACOs whose scores on readmissions measures (ACO-8, all-cause readmissions and ACO-35, SNF readmissions) fall below the 30th percentile should be eligible to have their quality score adjusted to account for the natural disaster.
For these reasons, we are declining at this time to adopt commenters' recommendations that we consider prior year quality scores as part of determining the quality performance scores of ACOs affected by extreme and uncontrollable circumstances and are finalizing the proposed policy. We are also declining to adopt the commenter's recommendation to give special consideration to ACOs based on their performance on the ACO-8 and ACO-35 readmissions measures. We would also like to clarify that both the policy that we finalized for performance year 2017 in the Shared Savings Program IFC and the policy we are finalizing in this rule for performance year 2018 and subsequent performance years would apply to all ACOs deemed to be affected by an extreme and uncontrollable circumstance (20 percent or more of assigned beneficiaries residing in an
After considering the comments received, we are finalizing our proposals to extend the policies for determining the quality scores for ACOs affected by extreme and uncontrollable circumstances established for performance year 2017 to performance year 2018 and subsequent performance years. Specifically, we are revising §§ 425.502(e) and 425.502(f) to state that for performance year 2018 and subsequent performance years, including the applicable quality data reporting period for the performance year, if the reporting period is not extended, in the event that we determine that 20 percent or more of an ACO's assigned beneficiaries, as determined using the list of assigned beneficiaries used to generate the Web Interface quality reporting sample, reside in an area that is affected by an extreme and uncontrollable circumstance, as determined under the Quality Payment Program, or that the ACO's legal entity is located in such an area, we will use the following approach to calculate the ACO's quality performance score:
• The ACO's minimum quality score will be set to equal the mean quality performance score for all Shared Savings Program ACOs for the applicable performance year.
• If the ACO is able to completely and accurately report all quality measures, we will use the higher of the ACO's quality performance score or the mean quality performance score for all Shared Savings Program ACOs. If the ACO's quality performance score is used, the ACO will also be eligible for quality improvement points.
• If the ACO receives the mean Shared Savings Program quality performance score, the ACO will not be eligible for bonus points awarded based on quality improvement during the applicable performance year.
• If an ACO receives the mean Shared Savings Program ACO quality performance score for a performance year, in the next performance year for which the ACO reports quality data and receives a quality performance score based on its own performance, we will measure quality improvement based on a comparison between the ACO's performance in that year and in the most recently available prior performance year in which the ACO reported quality.
We clarify that if an ACO reports quality data in a year in which it is affected by an extreme and uncontrollable circumstance, but receives the national mean quality score, we will use the ACO's own quality performance score to determine quality improvement bonus points in the following year. For example, if an ACO reported quality data in years 1, 2, and 3 of an agreement period, but received the national mean quality score in year 2 as the result of an extreme or uncontrollable circumstance, we would determine quality improvement bonus points for year 3 by comparing the ACO's year 3 quality score with its year 2 score. If the ACO received the mean score in year 2 because it did not report quality, we would compare year 3 with year 1 to determine the bonus points for year 3.
We also want to clarify one point regarding the interaction between this alternative quality scoring methodology and MIPS. As we noted above, the MIPS quality performance category is reweighted to zero if a disaster-affected ACO receives the mean quality score under the Shared Savings Program's extreme and uncontrollable circumstance policy, because it did not or could not report quality data at the ACO (APM Entity) level, regardless of whether or not any of the ACOs participant TINs reported quality outside the ACO. This reweighting under MIPS results in MIPS performance category weighting of 75 percent for the PI performance category and 25 percent for IA performance category. If, for any reason, the PI performance category also is reweighted to zero, which could be more likely when there is a disaster, there would be only one performance category triggering the policy under which the ACO in question would receive a neutral (threshold) MIPS score, as per § 414.1380(c) (see discussion at 83 FR 53778). If any of the ACO's participant TINs do report PI, then the TIN or TINs' PI performance category scores will be used to score the ACO under the MIPS scoring standard, the PI performance category will not be reweighted, and the policy to assign a neutral (threshold) MIPS score will not be triggered.
In the Shared Savings Program IFC (82 FR 60916) we modified the payment methodology for performance year 2017 for performance-based risk tracks established under the authority of section 1899(i) of the Act, to mitigate shared losses owed by ACOs affected by extreme and uncontrollable circumstances during 2017. Under this approach, we reduced the ACO's shared losses, if any, determined to be owed for performance year 2017 under the existing methodology for calculating shared losses in the Shared Savings Program regulations at 42 CFR part 425 subpart G by an amount determined by multiplying the shared losses by two factors: (1) The percentage of the total months in the performance year affected by an extreme and uncontrollable circumstance; and (2) the percentage of the ACO's assigned beneficiaries who resided in an area affected by an extreme and uncontrollable circumstance. For performance year 2017, we determined the percentage of the ACO's performance year assigned beneficiary population that was affected by the disaster based on the final list of beneficiaries assigned to the ACO for the performance year. For example, assume that an ACO was determined to owe shared losses of $100,000 for performance year 2017, a disaster was declared for October through December during the performance year, and 25 percent of the ACO's assigned beneficiaries resided in the disaster area. In this scenario, we would have adjusted the ACO's shared losses in the following manner: $100,000−($100,000 × 0.25 × 0.25) = $100,000−$6,250 = $93,750. The policies for performance year 2017 are specified in paragraph (i) in § 425.606 for ACOs under Track 2 and § 425.610 for ACOs under Track 3.
In the August 2018 proposed rule (83 FR 41903), we stated our belief that it would be appropriate to continue to apply these policies in performance year 2018 and subsequent years to address stakeholders' concerns that ACOs participating under a performance-based risk track could be held responsible for sharing losses with the Medicare program resulting from catastrophic events outside the ACO's control given
Additionally, we proposed to also address the possibility that ACOs that have a 6-month performance year during 2019 may be affected by extreme and uncontrollable circumstances. In this final rule, we are addressing the proposals specific to the 6-month performance year from January 1, 2019 through June 30, 2019. In a forthcoming final rule, we anticipate discussing comments received on the proposals related to policies for the 6-month performance year from July 1, 2019 through December 31, 2019, and the performance period from January 1, 2019 through June 30, 2019 for ACOs that terminate their agreement effective June 30, 2019, and enter a new agreement period starting on July 1, 2019. We anticipate this discussion will include a description of the applicability of policies for determining shared losses for ACOs affected by extreme and uncontrollable circumstances.
As described in section II.A.7. of the August 2018 proposed rule (83 FR 41849 through 41853) and the proposed provision at § 425.609, we proposed to use 12 months of expenditure data, based on the calendar year, to perform financial reconciliation for the 6-month performance year from January 1, 2019 through June 30, 2019. Accordingly, for ACOs participating in a 6-month performance year during the first half of 2019, we believed it would be necessary to account for disasters occurring in any month(s) of CY 2019, regardless of whether the ACO is actively participating in the Shared Savings Program at the time of the disaster.
For ACOs with a 6-month performance year that are affected by an extreme or uncontrollable circumstance during CY 2019, we proposed to first determine shared losses for the ACO over the full calendar year, adjust the shared losses for extreme and uncontrollable circumstances, and then determine the portion of shared losses for the 6-month performance year according to the methodology proposed under § 425.609. For example, assume that: A disaster was declared for October 2019 through December 2019; an ACO is being reconciled for its participation during the performance year from January 1, 2019 through June 30, 2019; the ACO is determined to have shared losses of $100,000 for CY 2019; and 25 percent of the ACO's assigned beneficiaries reside in the disaster area. In this scenario, we would adjust the ACO's losses in the following manner: $100,000−($100,000 × 0.25 × 0.25) = $100,000−$6,250 = $93,750, then we would multiply these losses by the portion of the year the ACO participated = $93,750 × 0.5 = $46,875.
Therefore, we proposed to amend §§ 425.606(i) and 425.610(i) to extend the policies regarding extreme and uncontrollable circumstances that were established for performance year 2017 to performance year 2018 and subsequent years. In addition, we proposed to include a provision at § 425.609(d) to provide that the policies on extreme and uncontrollable circumstances would apply to the determination of shared losses for ACOs participating in a 6-month performance year during 2019.
In the August 2018 proposed rule (83 FR 41904), we noted that to the extent that our proposal to extend the policies adopted in the Shared Savings Program IFC to 2018 and subsequent performance years constitutes a proposal to change the payment methodology for 2018 after the start of the performance year, we believe that consistent with section 1871(e)(1)(A)(ii) of the Act, and for the reasons discussed in section II.E.4 of the August 2018 proposed rule (83 FR 41899 through 41906), it would be contrary to the public interest not to propose to establish a policy under which we would have the authority to adjust the shared losses calculated for ACOs in Track 2 and Track 3 for performance year 2018 to reflect the impact of any extreme or uncontrollable circumstances that may occur during the year.
We also explained that these proposed policies would not change the status of those payment models that meet the criteria to be Advanced APMs under the Quality Payment Program (see § 414.1415). Our proposed policies would reduce the amount of shared losses owed by ACOs affected by a disaster, but the overall financial risk under the payment model would not change and participating ACOs would still remain at risk for an amount of shared losses in excess of the Advanced APM generally applicable nominal amount standard. Additionally, these policies would not prevent an eligible clinician from satisfying the requirements to become a QP for purposes of the APM Incentive Payment (available for payment years through 2024) or higher physician fee schedule updates (for payment years beginning in 2026) under the Quality Payment Program.
We also emphasized that all ACOs would continue to be entitled to share in any savings they may achieve for a performance year. ACOs in all tracks of the program will continue to receive shared savings payments, if any, as determined under subpart G of the regulations. The calculation of savings and the determination of shared savings payment amounts for a performance year would not be affected by the proposed policies to address extreme and uncontrollable circumstances, except that the quality performance score for an affected ACO may be adjusted as described in section II.E.4 of the proposed rule.
We solicited comments on the proposed policies for assessing the financial performance of ACOs affected by an extreme or uncontrollable circumstance during performance year 2018 and subsequent years.
Several commenters shared the opinion that the proposed policy of adjusting shared losses adequately addresses the situation of ACOs that would have had shared losses in the absence of a natural disaster, but had higher shared losses as the result of the disaster. However, they expressed concern that the policy does not provide relief to ACOs that receive a smaller shared savings payment as a result of the disaster or ACOs for which an expenditure increase resulting from a disaster causes the ACO to fall short of its MSR (and thus miss out on shared savings entirely) or to exceed its MLR (and thus owe shared losses when it otherwise would not have had shared losses).
A few commenters recommended addressing this issue by modifying the update that is applied to an ACO's benchmark for a performance year that is affected by an extreme and uncontrollable circumstance. For example, these commenters recommended that CMS apply a growth rate that is the higher of the national growth rate for assignable beneficiaries or the regional growth rate for assignable beneficiaries (excluding an ACO's own assigned beneficiaries). They suggested that their recommendation should be used instead of the “current policy” for accounting for the impact of disasters on performance year expenditures, which they believed relies on the use of natural disaster payment modifiers. A few other commenters recommended that CMS use a blend of national and regional expenditure growth rates to update the benchmark as proposed in the August 2018 rule in “normal times” but use a purely regional growth rate in the event of an extreme and uncontrollable circumstance. The same commenters also suggested that CMS remove claims associated with disaster-affected beneficiaries during the relevant time periods or claims with a natural disaster payment modifier code, pending changes to improve these codes, when calculating performance or benchmark year expenditures. It was unclear, however, whether they meant for these claims adjustments to be made instead of or in addition to their recommended changes to the update factors applied to the historical benchmark.
Several commenters raised concerns about the existing natural disaster modifier codes and whether, in their current form, they could be used to try to capture the negative impact on an ACO's performance. They noted that some health care providers may not be aware of the existence of such codes and that the codes may not be used properly due to lack of training and competing priorities during an emergency event. They also noted that the existing codes do not capture instances of “unsafe place of discharge”, which they believe is a common reason for lengths of stay to be increased during a disaster and recommended that CMS expand existing modifier codes or add a new code to cover this circumstance. A few commenters recommended providing proper education on the use of such codes, which would allow these codes to serve as a more accurate means for identifying the impacts of natural disasters. Another commenter recommended that CMS allow an additional 6 to 12 months for providers to submit such codes to be considered in expenditure calculations.
Furthermore, we note that although we considered the use of natural disaster payment modifiers in developing the original extreme and uncontrollable circumstances policy for performance year 2017, we did not adopt a policy that used such codes in the Shared Savings Program IFC, nor did we propose in the August 2018 proposed rule to use such codes to adjust benchmark or performance year expenditure calculations for performance year 2018 or subsequent years. We have examined the existing natural disaster payment modifiers (specifically the “DR” condition code used on institutional claims and the “CR” modifier code used on Part B institutional and non-institutional claims) in 2017 claims for ACO assigned beneficiaries. We found that these codes were not widely or consistently used and that there appears to be variation in their use among ACOs. For example, among 69 ACOs with 90 percent or more of assigned beneficiaries residing in a disaster affected area, we found that only 0.01 percent of institutional claims and only 0.0006 percent of non-institutional claims included such a code. Among this same group of ACOs, the total number of claims (institutional or non-institutional) containing one of these codes ranged from 0 to 155 with a mean of 14 and a median of 8. In a separate analysis, we found that claims completion rates were comparable in disaster-affected and non-affected years which suggests that the low levels of modifier usage are not necessarily due to delayed claim submission. Based on these analyses, as well as the comments offered in response to the August 2018 proposed rule, we also have concerns that these codes would not serve as a useful means for comprehensively identifying relevant claims.
As we described in the August 2018 proposed rule, and have recounted in this final rule, we have some concerns about removing claims for affected beneficiaries and time periods from benchmark year expenditure calculations. As we develop additional experience, we may revisit this policy and, if warranted, propose modifications to performance or benchmark year expenditure calculations for ACOs affected by extreme and uncontrollable circumstances through further notice and comment rulemaking.
We also note that, although the policies regarding extreme and uncontrollable circumstances we are finalizing in this final rule do not include an explicit adjustment to the shared savings payment of a disaster-affected ACO, our alternative methodology for quality scoring can indirectly increase an ACO's shared savings payment. In performance year 2017, 62 of 117 disaster-affected ACOs received the national mean quality score, as it was higher than the score the
After considering the comments received, we are finalizing our proposal to extend the policy for mitigating shared losses owed by ACOs affected by extreme and uncontrollable circumstances established for performance year 2017 to performance year 2018 and subsequent performance years. We are revising §§ 425.606(i) and 425.610(i) to indicate that we will reduce the amount of shared losses calculated for the performance year by an amount determined by multiplying (1) the percentage of the total months in the performance year affected by an extreme and uncontrollable circumstance; and (2) the percentage of the ACO's assigned beneficiaries who reside in an area affected by an extreme and uncontrollable circumstance. We are also finalizing our proposal, through a new provision at § 425.609(d), to adjust shared losses for ACOs with a 6-month performance year from January 1, 2019 through June 30, 2019. For ACOs in a 6-month performance year we will first determine shared losses for the ACO over the full calendar year, reduce the ACO's shared losses for the calendar year for extreme and uncontrollable circumstances, and then determine the portion of shared losses for the 6-month performance year.
In the Shared Savings Program IFC, we sought comment on how to address the impact of extreme and uncontrollable circumstances on the expenditures for an ACO's assigned beneficiary population for purposes of determining the benchmark (82 FR 60917). As we explained in the Shared Savings Program IFC (82 FR 60913), the impact of disasters on an ACO's financial performance could be unpredictable as a result of changes in utilization and cost of services furnished to the Medicare beneficiaries it serves. In some cases, ACO participants might be unable to coordinate care because of migration of patient populations leaving the impacted areas. On the other hand, patient populations remaining in impacted areas might receive fewer services and have lower overall costs to the extent that healthcare providers are unable to reopen their offices because they lack power and water or have limited access to fuel for operating alternate power generators. Significant changes in costs incurred, whether increased or decreased, as a result of an extreme or uncontrollable circumstance may impact the benchmark determined for the ACO's subsequent agreement period in the Shared Savings Program, as performance years of the current agreement period become the historical benchmark years for the subsequent agreement period. An increase in expenditures for a particular calendar year would result in a higher benchmark value when the same calendar year is used to determine the ACO's historical benchmark, and in calculating adjustments to the rebased benchmark based on regional FFS expenditures. Likewise, a decrease in expenditures for a particular calendar year would result in a lower benchmark value when the same calendar year is used to determine the ACO's historical benchmark.
While considering options for adjusting ACOs' historical benchmarks to account for disasters occurring during a benchmark year, we considered the effect that the proposed regional factors, that are discussed in section II.D.3. of the August 2018 proposed rule (83 FR 41886 through 41891), might have on the historical benchmarks for ACOs located in a disaster area. After review, we explained that we believe that when regional factors are applied to an ACO's historical benchmark, the regional factors would inherently adjust for variations in expenditures from year to year, and thus would also adjust for regional variations in expenditures related to extreme and uncontrollable circumstances. For example, assume that an ACO experienced a reduction in beneficiary expenditures in performance year 2017 because a portion of its assigned beneficiaries resided in counties that were impacted by a disaster. Then, also assume expenditures returned to their previously higher level in 2018 and this ACO subsequently renewed its ACO participation agreement in 2020. In 2020, when the ACO's historical benchmark would be reset (rebased), the expenditures for 2017 (now a historical benchmark year) would be subject to a higher regional trend factor because expenditures increased back to the expected level in 2018, which would increase the 2017 benchmark year expenditures. Additionally, this ACO could also have its historical benchmark increased even further as a result of its performance compared to others in its region, as reflected in the regional adjustment to the ACO's historical benchmark. In contrast, consider an ACO that experienced an increase in beneficiary expenditures in performance year 2017 because a portion of its assigned beneficiaries resided in counties that were impacted by a disaster. Then, assume expenditures returned to their previously lower level in 2018 and this ACO renewed its ACO participation agreement in 2020. In 2020, when the ACO's historical benchmark would be reset, the expenditures for 2017 would be subject to a lower regional trend factor because expenditures decreased back to the expected level in 2018, which would decrease the 2017 benchmark year expenditures. Additionally, this ACO could also have its historical benchmark decreased further as a result of its performance compared to others in its region, as reflected in the regional adjustment to the ACO's historical benchmark.
Our expectation that the proposed regional factors that would be used to establish an ACO's historical benchmark would also adjust for variations in expenditures related to extreme and uncontrollable circumstances was supported by a preliminary analysis of data for areas that were affected by the disasters that occurred in performance year 2017. Our analysis of the data showed that, as a result of the disasters in these areas, expenditure trends for the performance year appeared below projections. For these areas, the expenditures began to increase after the disaster incident period ended, but expenditures were still below expectations for the year. Based on the expenditure trends beginning to return to expected levels after the disaster period, it would be reasonable to expect that expenditures would continue to increase to expected levels in 2018. This difference between the lower than expected levels of expenditures in 2017 and a return to expected expenditures in 2018, would result in a higher regional trend factor being applied to 2017 expenditures when they are used to determine an ACO's historical benchmark. Although our analysis for the proposed rule was performed using the proposed regional factors, we expect that our existing benchmarking methodology at § 425.603, which also incorporates regional factors in the determination of an ACO's historical benchmark for its second or subsequent agreement period beginning in 2017 or later years, would have a similar result.
In the August 2018 proposed rule (83 FR 41905), in considering whether it might be necessary to make an additional adjustment to ACOs' historical benchmarks to account for expenditure variations related to extreme and uncontrollable circumstances, we considered an approach where we would adjust the historical benchmark by reducing the weight of expenditures for beneficiaries who resided in a disaster area during a
We noted that if we were to implement such an adjustment to the historical benchmark, we believed it would be appropriate to avoid making minor historical benchmark adjustments for an ACO that was not significantly affected by a disaster by establishing a minimum threshold for the percentage of an ACO's beneficiaries located in a disaster area. Based on data from 2017, quarter 3, over 80 percent of ACOs had less than 50 percent of their assigned beneficiaries residing in disaster counties, with over 75 percent having less than 10 percent of their assigned beneficiaries residing in disaster counties. Based on this data, we noted our belief that a minimum threshold of 50 percent of assigned beneficiaries residing in disaster counties could be an appropriate threshold for the adjustment to historical benchmarks because historical benchmarks are calculated based on the ACO's entire assigned beneficiary population in each benchmark year, rather than a sample as is used for quality reporting.
However, we were concerned that this methodology for calculating an adjustment might not be as accurate as the inherent adjustment that would result from applying regional factors when resetting the benchmark and may impact other expected expenditure variations occurring in the impacted areas. For example, if an additional disaster adjustment were to be applied, it might have unintended impacts when expenditure truncation is applied, it might inappropriately weight and not account for expected variations in expenditures between areas that were and were not impacted by the disaster, and it might compound effects that have already been offset by the regional adjustment. In addition, the expenditures, as adjusted, may not be representative of the ACO's actual performance and aggregate assigned beneficiary population during the benchmark period.
In summary, we noted our belief that the regional factors that we had proposed to apply as part of the methodology for determining an ACO's historical benchmark would reduce the expenditures in a historical benchmark year when they are greater than expected (relative to other historical benchmark years) as a result of a disaster and conversely increase expenditures in a historical benchmark year when they are below the expected amount. For these reasons, we believed that the proposal in section II.D.3. of the August 2018 proposed rule (83 FR 41887 through 41888) to apply regional factors when determining ACOs' historical benchmarks, starting with an ACO's first agreement period for agreement periods starting on July 1, 2019, and in subsequent years, would be sufficient to address any changes in expenditures during an ACO's historical benchmark years as a result of extreme and uncontrollable circumstances, and an additional adjustment, such as the method discussed previously in this section would not appear to be necessary. However, we noted that we would continue to evaluate the impact of the 2017 disasters on ACOs' assigned beneficiary expenditures, and that we intended to continue to consider whether it might be appropriate to make an additional adjustment to the historical benchmark to account for expenditures that may have increased or decreased in a historical benchmark year as a result of an extreme or uncontrollable circumstance.
We solicited comments on these issues, including whether it is necessary to adjust ACOs' historical benchmarks to account for extreme and uncontrollable circumstances that might occur during a benchmark year, and appropriate methods for making such benchmark adjustments. We also noted that the proposal in section II.D.3. of the August 2018 proposed rule to apply regional factors to determine ACOs' historical benchmarks would apply starting with an ACO's first agreement period for agreement periods starting on July 1, 2019, and in subsequent years and would therefore have no effect on benchmarks for ACOs in a first agreement period starting before July 1, 2019 (see 83 FR 41887). Accordingly, we solicited comments on whether and how an adjustment should be made for ACOs whose benchmarks do not reflect regional factors. We also invited comments on any additional areas where relief may be helpful or other ways to mitigate unexpected issues that may arise in the event of an extreme and uncontrollable circumstance.
As described in the prior section V.B.2.d.(2) of this final rule, we have concerns about commenters' recommendation to exclude claims with a natural disaster modifier code, or claims associated with disaster affected beneficiaries and time periods from benchmark or performance year expenditures. As we develop additional experience, we may revisit this policy and, if warranted, propose modifications to our methodology for calculating performance year or benchmark year expenditures through further notice and comment rulemaking.
After considering comments we received on the determination of historical benchmarks for ACOs in areas affected by extreme and uncontrollable circumstances, we are not making any changes to the benchmarking methodology to address such events at this time. We will continue to monitor the impact of extreme and uncontrollable circumstances on benchmark expenditures and, if applicable, the extent to which any impact is mitigated by the use of regional factors in establishing and updating the benchmark. If warranted, we will propose additional modifications to our benchmarking methodology to address the effects of extreme and uncontrollable circumstances through future notice and comment rulemaking.
In section II.E.5. of the August 2018 proposed rule (41906 through 41908), we solicited comments on possible changes to the quality measure set and modifications to program data shared with ACOs to support CMS' Meaningful Measures initiative and respond to the nation's opioid misuse epidemic. As part of the Meaningful Measures initiative, the agency's efforts are focused on updating quality measures, reducing regulatory burden, and promoting innovation (see CMS Press Release, CMS Administrator Verma Announces New Meaningful Measures Initiative and Addresses Regulatory Reform; Promotes Innovation at LAN Summit, October 30, 2017, available at
Since the Shared Savings Program was first established in 2012, we have not only updated the quality measure set to reduce reporting burden, but also to focus on more meaningful outcome-based measures. The most recent updates to the Shared Savings Program quality measure set were made in the CY 2017 PFS Final Rule (81 FR 80484 through 80489) to adopt the ACO measure recommendations made by the Core Quality Measures Collaborative, a multi-stakeholder group with the goal of aligning quality measures for reporting across public and private stakeholders in order to reduce provider reporting burden. Currently, more than half of the 31 Shared Savings Program quality measures are outcome-based, including—
• Patient-reported outcome measures collected through the CAHPS for ACOs Survey that strengthen patient and caregiver experience;
• Outcome measures supporting care coordination and effective communication, such as unplanned admission and readmission measures; and
• Intermediate outcome measures that address the effective treatment of chronic disease, such as hemoglobin A1c control for patients with diabetes and control of high blood pressure.
As we explained in the August 2018 proposed rule (83 FR 41906), it is important that the quality reporting requirements under the Shared Savings Program align with the reporting requirements under other Medicare initiatives and those used by other payers in order to minimize the need for Shared Savings Program participants to devote excessive resources to understanding differences in measure specifications or engaging in duplicative reporting. We sought comment, including recommendations and input on meaningful measures, on how we may be able to further advance the quality measure set for ACO reporting, consistent with the requirement under section 1899(b)(3)(C) of the Act that the Secretary seek to improve the quality of care furnished by ACOs by specifying higher standards, new measures, or both.
One particular area of focus by the Department of Health and Human Services is the opioid misuse epidemic. The Centers for Disease Control and Prevention (CDC) reports that the number of people experiencing chronic pain lasting more than 3 months is estimated to include 11 percent of the adult population. According to a 2016 CDC publication, 2 million Americans had opioid use disorder (OUD) associated with prescription opioids in 2014 (
As part of a multifaceted response to address the growing problem of overuse and abuse of opioids in the Part D program, CMS adopted a policy in 2013 requiring Medicare Part D plan sponsors to implement enhanced drug utilization review. Between 2011 through 2014, there was a 26 percent decrease or 7,500 fewer Medicare Part D beneficiaries identified as potential opioid over-utilizers which may be due, at least in part, to these new policies. On January 5, 2017, CMS released its Opioid Misuse Strategy. This document outlines CMS' strategy and the array of actions underway to address the national opioid misuse epidemic and is available at
We aim to align our policies under the Shared Savings Program with the priorities identified in the Opioid Misuse Strategy and the Department of Health and Human Services Strategy to Combat Opioid Abuse, Misuse, and Overdose
First, we are considering what information, including what aggregated Medicare Part D data, could be useful to ACOs to combat opioid misuse in their assigned beneficiary population. We recognize the importance of available and emerging resources regarding the opioid epidemic at the federal, state, and local level, and intend to work with our federal partners to make relevant resources available in a timely manner to support ACOs' goals and activities. We will also continue to share information with ACOs highlighting Federal opioid initiatives, such as the CDC Guideline for Prescribing Opioids for Chronic Pain (
Although we recognize that not all beneficiaries assigned to Shared Savings Program ACOs have Part D coverage, we believe a sufficient number do have Part D coverage to make aggregate Part D data regarding opioid use helpful for the ACOs. As an example, we have found the following information for performance year 2016:
• Approximately 70 percent of beneficiaries assigned to ACOs participating in the Shared Savings Program had continuous Part D coverage.
• For assigned beneficiaries with continuous Part D enrollment, almost 37 percent had at least one opioid prescription. This percentage ranged from 10.6 percent to 58.3 percent across ACOs.
• The mean number of opioid medications filled per assigned beneficiary (with continuous Part D coverage) varied across ACOs, ranging from 0.3 to 4.5 prescriptions filled, with an average of 2.1 prescriptions filled.
• The number of opioid prescriptions filled for each assigned beneficiary with at least one opioid prescription filled varied across ACOs and ranged from 2.6 to 8.4 prescriptions, with an average of 5.5 opioid prescriptions filled.
ACOs currently receive, as part of the monthly claims and claims line feed data, Part D prescription drug event (PDE) data on prescribed opioids for their assigned beneficiaries who have not opted out of data sharing. We encourage ACOs to use this beneficiary-level data in their care delivery practices.
In the August 2018 proposed rule (83 FR 41907), we sought suggestions for other types of aggregate data related to opioid use that could be added for informational purposes to the aggregate quarterly and annual reports CMS provides to ACOs. The aim would be for ACOs to utilize this additional information to improve population health management for assigned beneficiaries, including prevention, identifying anomalies, and coordinating care. The type of aggregate data should be highly relevant for a population-based program at the national level and have demonstrated value in quality improvement initiatives. We noted that we are particularly interested in high impact aggregate data that would reflect gaps in quality of care, patient safety, multiple aspects of care, and drivers of cost. We aim to provide aggregate data that have validity for longitudinal analysis to enable both ACOs and the Shared Savings Program to trend performance across time and monitor for changes. Aggregate data on both processes and outcomes are appropriate, provided that the data are readily available. Types of aggregate data that we have begun to consider, based on the information available from prescription drug event records for assigned beneficiaries enrolled in Medicare Part D, include filled prescriptions for opioids (percentage of the ACO's assigned beneficiaries with any opioid prescription, number of opioid prescriptions per opioid user), number of beneficiaries with a concurrent prescription of opioids and benzodiazepines; and number of beneficiaries with opioid prescriptions above a certain daily Morphine Equivalent Dosage threshold. We also sought comments on measures that could be added to the quality measure set for the purpose of addressing the opioid epidemic and addiction, more generally. We sought comment on measures related to various aspects of opioid use, such as prevention, pain management, or opioid use disorder treatment, and on measures related to addiction. In particular, we noted that we were considering the following relevant NQF-endorsed measures, with emphasis on Medicare beneficiaries with Part D coverage who are 18 years or older without cancer or enrolled in hospice:
• NQF #2940 Use of Opioids at High Dosage in Persons Without Cancer: Analyzes the proportion (XX out of 1,000) of Medicare Part D beneficiaries
• NQF #2950 Use of Opioids from Multiple Providers in Persons Without Cancer: Analyzes the proportion (XX out of 1,000) of Medicare Part D beneficiaries 18 years or older without cancer or enrolled in hospice receiving prescriptions for opioids from four (4) or more prescribers AND four (4) or more pharmacies.
• NQF #2951 Use of Opioids from Multiple Providers and at High Dosage in Persons Without Cancer: Analyzes the proportion (XX out of 1,000) of Medicare Part D beneficiaries 18 years or older without cancer or enrolled in hospice with a daily dosage of morphine milligram equivalent (MME) greater than 120 mg for 90 consecutive days or longer, AND who received opioid prescriptions from four (4) or more prescribers AND four (4) or more pharmacies.
In addition, we sought input on potential measures for which data are readily available, such as measures that might be appropriately calculated using Part D data, and that capture performance on outcomes of appropriate opioid management. We requested that comments on measures that are not already NQF endorsed include descriptions of reliability, validity, benchmarking, the population in which the measure was tested, along with the data source that was used, and information on whether the measure is endorsed and by what organization. We recognized that measures of the various aspects of opioid use may involve concepts related to integrated, coordinated, and collaborative care, including as applicable for co-occurring and/or chronic conditions, as well as measures that reflect the impact of interventions on patient outcomes, including direct and indirect patient outcome measures. We also sought comment on opioid-related measures that would support effective measurement alignment of substance use disorders across programs, settings, and varying interventions.
Several commenters supported the agency's Meaningful Measures Initiative stating that CMS should not only consider whether a measure is a process measure, but also whether the measure is considered a low-value process measure, before removing it from the Shared Savings Program quality measure set. In addition, these commenters supported CMS' move toward the use of outcome measures, as the emphasis on improved health outcomes is an appropriate focus and goal.
Several commenters suggested future potential refinements to the Shared Savings Program measure set. One commenter urged CMS to better align the Shared Savings Program with Medicare Advantage, suggesting that there should be fewer measures that are included in a roadmap for implementation in both programs, because the different measures and the differing standards for compliance that are currently used cause confusion and require the use of limited provider and staff resources. In addition, this commenter stated that with a roadmap of measures, organizations would be able to focus their energies on achieving these metrics in a systematic and deliberate fashion.
Another commenter expressed concern with the timing and burden of quality measurement and payment, suggesting that we streamline quality efforts to include ten specific outcome measures that have a social and public health impact and offering a financial incentive in connection with each measure to encourage physicians to drive, fund, and sustain continued quality efforts.
A few commenters suggested that CMS should focus on the prevention, treatment, and management of behavioral health. They stated that in the absence of effective behavioral health assessment tools, the vast majority of people with mental health conditions go unidentified in primary care settings, which in most cases leads to non-adherent patients and higher total medical costs. In addition, they stated that behavioral health is central to the prevention, treatment, and management of the preventable manifestations of diseases and health conditions. They suggested that CMS consider including broader measures that would encourage behavioral health and medical providers to work collaboratively to provide coordinated care.
Several commenters suggested that CMS consider developing a quality measure set that would evaluate the breadth of chronic conditions common in the patient population assigned to Shared Savings Program ACOs and use appropriate outcome measures to ensure assigned beneficiaries are receiving the necessary care. They noted that the proposed Shared Savings Program quality measure set discussed in section III.F.1.c. of the CY 2019 PFS proposed rule (83 FR 35876 through 35878) does not include measures related to respiratory conditions, like chronic obstructive pulmonary disease or asthma, diabetes, or additional conditions like heart failure. They encouraged CMS to include measures that evaluate the quality of care for these conditions, such as, measures focused on the delivery of comprehensive lower extremity exams for diabetic patients, and rates of complications such as amputation. They stated that greater emphasis on management of chronic conditions is necessary to promote quality and improve patient outcomes. Another commenter suggested CMS should increase the number of claims-based measures in the Shared Savings Program measure set and provide ACOs with user-friendly, actionable reports that detail the ACO-specific data used to calculate specific measure performance. One commenter suggested that CMS consider quality measures that reinforce shared decision making, as part of treatment plans that align with the individual's goals as this is a foundational component of high-quality patient-centered care.
Several commenters supported CMS' efforts to consider the possible addition of opioid use measures to the Shared Savings Program quality measure set in future program years, but some commenters recommended that CMS work with the measure developer and NQF to reduce the dosage threshold of two of the measures discussed in the August 2018 proposed rule to 90 MME per day to align with the CDC guidelines for Prescribing Opioids for Chronic Pain. Another commenter agreed that promoting the measurement of opioid use and overuse, monitoring, and education through quality reporting is an important step in understanding and addressing the opioid crisis. A few commenters recommended that CMS utilize the Prescription Drug Monitoring Program (PDMP) Query measure, as most states have implemented PDMPs, and the PDMP Query measure is a reasonable step to improve and measure quality in opioid prescribing.
Another commenter stated that in general they support CMS' considering the addition of opioid use measures to the Shared Savings Program measure set; however, they expressed their belief that opioid dosage measures are of low-value to the program because, “. . . since the issuance of Centers for Disease Control (CDC) and Prevention guidelines, there have been many reports of patients who have been successfully managed on opioid analgesics for long periods of time.” This commenter noted that implementing a quality measure that could force a health provider to abruptly reduce or discontinue this medication regimen could have extreme adverse outcomes such as depression, loss of function, or even suicide. The commenter suggested CMS consider quality measures other than dosage measures when determining the most appropriate metrics to help address and respond to the opioid crisis.
One commenter expressed concern with the specific opioid related measures on which CMS sought comment for potential inclusion in the Shared Savings Program quality measure set. The commenter stated that quality measurement needs to focus on utilization of preventive strategies, such as screening and treatment for substance abuse, as well as pain management. This commenter disagreed with the potential inclusion of
Another commenter noted that the three opioid measures CMS suggested for inclusion in the Shared Savings Program measure set are appropriately focused on the right patient population and address the major risks associated with opioid misuse—high dosages and multiple prescriptions. However, the commenter urged CMS to conduct testing to ensure the measures provide accurate, reliable data at the ACO level, as they are currently endorsed at the health plan level not the ACO level. The commenter suggested that the measures should be reported on a voluntary or pay-for-reporting basis rather than as pay-for-performance measures for the first few years after they are added to the measure set.
Another commenter expressed concern that including measures that are so specific will distract ACOs from focusing on what works for them and their assigned beneficiary population. As an alternative, the commenter suggested CMS provide webinars, education, tools, and data for ACOs to incorporate into their current structure for care management and patient engagement. Several commenters recommended that CMS provide aggregated data to ACOs on opioid use, but they also urged CMS to go further and provide aggregated beneficiary data on the use of all prescribed medications and their related diagnoses. Similarly, another commenter encouraged CMS to continue to add more real-time data to the quarterly quality reports so providers can leverage this data to improve patient care, address social inequities in health, correct inefficiencies to drive down costs, and help to address the nation's opioid epidemic and other pressing health crises.
Consistent with the call in the 21st Century Cures Act for interoperable access, exchange, and use of health information, the final rule entitled, 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications (2015 Edition final rule) (80 FR 62601) under 45 CFR part 170
Under the Shared Savings Program, section 1899(b)(2)(G) of the Act requires participating ACOs to define processes to report on quality measures and coordinate care, such as through the use of telehealth, remote patient monitoring, and other such enabling technologies. Consistent with the statute, ACOs participating in the Shared Savings Program are required to coordinate care across and among primary care physicians, specialists, and acute and post-acute providers and suppliers and to have a written plan to encourage and promote the use of enabling technologies for improving care coordination, including the use of electronic health records and electronic exchange of health information (§ 425.112(b)(4)). Additionally, since the inception of the program in 2012, CMS has assessed the level of CEHRT use by certain clinicians in the ACO using a double-weighted quality measure (Use of Certified EHR Technology, ACO-11) as part of the quality reporting requirements for each performance year. Based on previously-finalized policies, for the 2018 performance year, we will use data derived from the Quality
In the August 2018 proposed rule (83 FR 41908), we noted that some alternative payment models tested by the Innovation Center, require all participants to use CEHRT even though certain tracks within those Models do not meet the financial risk standard for designation as Advanced APMs. The primary rationale for this requirement is to promote CEHRT use by eligible clinicians and organizations participating in APMs by requiring them to demonstrate a strong commitment to the exchange of health information, regardless of whether they are participating in an APM that meets the criteria to be designated as an Advanced APM. Under the Quality Payment Program, an incentive payment will be made to certain Qualifying APM Participants (QPs) participating in Advanced APMs. Beginning in 2017, an eligible clinician can become a QP for the year by participating sufficiently in an Advanced APM during the QP performance period. Eligible clinicians who are QPs for a year receive a lump sum APM incentive payment for payment years from 2019 through 2024, and are excluded from the MIPS reporting requirements for the performance year and the MIPS payment adjustment for the payment year. In the CY 2017 Quality Payment Program final rule (81 FR 77408), 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. An Advanced APM is an APM that, among other criteria, requires its participants to use CEHRT. In the CY 2017 Quality Payment Program final rule, we established that Advanced APMs meet this requirement if the APM either—(1) requires at least 50 percent of eligible clinicians in each participating APM Entity, or for APMs in which hospitals are the APM Entities, each hospital, to use CEHRT to document and communicate clinical care to their patients or other health care providers; or (2) for the Shared Savings Program, applies a penalty or reward to an APM Entity based on the degree of the use of CEHRT of the eligible clinicians in the APM Entity (§ 414.1415(a)(1)(i) and (ii)). In the CY 2017 PFS final rule, we updated the title and specifications of the EHR quality measure (ACO-11) to align with the Quality Payment Program criterion on CEHRT use in order to ensure that certain tracks under the Shared Savings Program could meet the criteria to be Advanced APMs. Specifically, we revised the ACO-11 measure to assess ACOs on the degree of CEHRT use by all eligible clinicians participating in the ACO. Performance on the measure is determined by calculating the percentage of eligible clinicians participating in the ACO who successfully meet the Promoting Interoperability Performance Category Base Score.
In light of our additional experience with the Shared Savings Program, our desire to continue to promote and encourage CEHRT use by ACOs and their ACO participants and ACO providers/suppliers, and our desire to better align with the goals of the Quality Payment Program and the criteria for participation in certain alternative payment models tested by the Innovation Center, in the August 2018 proposed rule, we indicated that we believe it would be appropriate to amend our regulations related to CEHRT use and the eligibility requirements for ACOs to participate in the Shared Savings Program. Specifically, we proposed to add a requirement that all ACOs demonstrate a specified level of CEHRT use in order to be eligible to participate in the Shared Savings Program. Additionally, we proposed that, as a condition of participation in a track, or a payment model within a track, that meets the financial risk standard to be an Advanced APM, ACOs must certify that the percentage of eligible clinicians participating in the ACO who use CEHRT to document and communicate clinical care to their patients or other health care providers meets or exceeds the threshold required for Advanced APMs as defined under the Quality Payment Program (§ 414.1415(a)(1)(i)). In conjunction with this proposed new eligibility requirement, we proposed to retire the EHR quality measure (ACO-11) related to CEHRT use, thereby reducing reporting burden, effective for quality reporting for performance years starting on January 1, 2019, and subsequent performance years. In addition, consistent with our proposal to align with the Advanced APM criterion on use of CEHRT, we proposed to apply the definition of CEHRT under the Quality Payment Program (§ 414.1305), including any subsequent updates to this definition, for purposes of the Shared Savings Program by adding a definition of “CEHRT” to § 425.20.
First, we proposed that for performance years starting on January 1, 2019, and subsequent performance years, ACOs in a track or a payment model within a track that does not meet the financial risk standard to be an Advanced APM would have to attest and certify upon application to participate in the Shared Savings Program, and subsequently, as part of the annual certification process, that at least 50 percent of the eligible clinicians participating in the ACO use CEHRT to document and communicate clinical care to their patients or other health care providers. ACOs would be required to submit this certification in the form and manner specified by CMS.
We stated that our proposed requirement aligned with the requirements regarding CEHRT use in many alternative payment models being tested by the Innovation Center. Additionally, we noted that at the time of application, ACOs must have a written plan to use enabling technologies, such as electronic health records and other health IT tools, to coordinate care (§ 425.112(b)(4)(i)(C)). Over the years, successful ACOs have impressed upon us the importance of “hitting the ground running” on the first day of their participation in the Shared Savings Program, rather than spending the first year or two developing their care processes. We stated our belief that requiring ACOs that are entering a track or a payment model within a track that does not meet the financial risk standard to be an Advanced APM to certify that at least 50 percent of the eligible clinicians participating in the ACO use CEHRT would align with existing requirements under the Shared Saving Program and many Innovation Center alternative payment models and encourage participation by organizations that are more likely to meet the program goals. In addition, we stated that such a requirement would also promote greater emphasis on the importance of CEHRT use for care coordination. Finally, we noted that in the CY 2019 PFS proposed rule, we had proposed to increase the threshold of
We proposed changes to the regulations at § 425.204(c) (to establish the new application requirement) and § 425.302(a)(3)(iii) (to establish the new annual certification requirement). We also proposed to add a new provision at § 425.506(f)(1) to indicate that for performance years starting on January 1, 2019, and subsequent performance years, all ACOs in a track or a payment model within a track that does not meet the financial risk standard to be an Advanced APM must certify that at least 50 percent of their eligible clinicians use CEHRT to document and communicate clinical care to their patients or other health care providers. We noted that this proposal, if finalized, would not affect the previously-finalized requirements for MIPS eligible clinicians reporting on the Promoting Interoperability (PI) performance category under MIPS. In other words, MIPS eligible clinicians who are participating in ACOs would continue to report as usual on the Promoting Interoperability performance category. We welcomed comment on these proposed changes. We also sought comment on whether the percentage of CEHRT use should be set at a level higher than 50 percent for ACOs in a track or a payment model within a track that does not meet the financial risk standard to be an Advanced APM given that average ACO performance on the Use of Certified EHR Technology measure (ACO-11) has substantially exceeded 50 percent, with ACOs reporting that on average roughly 80 percent of primary care physicians in their ACOs meet meaningful use requirements,
Further, for ACOs in tracks or models that meet the financial risk standard to be Advanced APMs under the Quality Payment Program, we proposed to align the proposed CEHRT use threshold with the criterion on use of CEHRT established for Advanced APMs under the Quality Payment Program. We noted that, although it would be ideal for all ACOs to meet the same CEHRT thresholds to be eligible for participation in the Shared Savings Program, there may be reasons why it may be desirable for ACOs in tracks or payment models within a track that do not meet the financial risk standard for Advanced APMs to have a different threshold requirement for CEHRT use than more sophisticated ACOs that are participating in tracks or payment models that qualify as Advanced APMs under the Quality Payment Program. For example, we noted that in order for an APM to meet the criteria to be an Advanced APM under the Quality Payment Program, it must currently require at least 50 percent of eligible clinicians in each participating APM entity to use CEHRT to document and communicate clinical care to their patients or other health care providers (in addition to certain other criteria). However, as previously noted, in the CY 2019 PFS proposed rule, we proposed to increase this threshold level under the Quality Payment Program to 75 percent of eligible clinicians in each participating Advanced APM entity. Therefore, for performance years starting on January 1, 2019, and subsequent performance years for Shared Savings Program tracks (or payment models within tracks) that meet the financial risk standard to be an Advanced APM, we proposed to align the CEHRT requirement with the Quality Payment Program Advanced APM CEHRT use criterion at § 414.1415(a)(1)(i). Specifically, we proposed that such ACOs would be required to certify that they meet the higher of the 50 percent threshold proposed for ACOs in a track (or a payment model within a track) that does not meet the financial risk standard to be an Advanced APM or the CEHRT use criterion for Advanced APMs under the Quality Payment Program at § 414.1415(a)(1)(i). We stated that requiring these ACOs to meet the higher of the 50 percent threshold proposed for ACOs in a track (or a payment model within a track) that does not meet the financial risk standard to be an Advanced APM or the CEHRT use criterion for Advanced APMs would ensure alignment of eligibility requirements across all Shared Savings Program ACOs, while also ensuring that if the CEHRT use criterion for Advanced APMs were higher than 50 percent, those Shared Savings Program tracks (or payment models within a track) that meet the financial risk standard to be an Advanced APM would also meet the CEHRT threshold established under the Quality Payment Program. We anticipated that for performance years starting on January 1, 2019, the tracks (or payment models within tracks) that would be required to meet the CEHRT threshold designated at § 414.1415(a)(1)(i) would include Track 2, Track 3, and the Track 1+ Model, and for performance years starting on July 1, 2019, would include the proposed BASIC track, Level E, and the proposed ENHANCED track. ACOs in these tracks (or a payment model within such a track) would be required to attest and certify that the percentage of the eligible clinicians in the ACO that use CEHRT to document and communicate clinical care to their patients or other health care providers meets or exceeds the level of CEHRT use specified under the Quality Payment Program regulation at § 414.1415(a)(1)(i). We noted that although this proposal might cause Shared Savings Program ACOs in different tracks (or different payment models within the same track) to be held to different requirements regarding CEHRT use, we believed it would be appropriate to ensure not only that ACOs that are still new to participation in the Shared Savings Program would not be excluded from the program due to a requirement that a high percentage of eligible clinicians participating in the ACO use CEHRT, but also that eligible clinicians in ACOs further along the risk continuum would have the opportunity to participate in an Advanced APM for purposes of the Quality Payment Program.
We proposed to add a new provision to the regulations at § 425.506(f)(2) to
We stated that, as a part of these proposals to require ACOs to certify that a specified percentage of their eligible clinicians use CEHRT, CMS would reserve the right to monitor, assess, and/or audit an ACO's compliance with respect to its certification of CEHRT use among its participating eligible clinicians, consistent with §§ 425.314 and 425.316, and to take compliance actions (including warning letters, corrective action plans, and termination) as set forth at §§ 425.216 and 425.218 when ACOs fail to meet or exceed the required CEHRT use thresholds. Additionally, we proposed to adopt for purposes of the Shared Savings Program the same definition of “CEHRT” as is used under the Quality Payment Program. We proposed to amend § 425.20 to incorporate a definition of CEHRT consistent with the definition at § 414.1305, including any subsequent updates or revisions to that definition. Consistent with this proposal and to ensure alignment with the requirements regarding CEHRT use under the Quality Payment Program, we also proposed to amend § 425.20 to incorporate the definition of “eligible clinician” at § 414.1305 that applies under the Quality Payment Program.
Additionally, we stated that if the proposal to introduce a specified threshold of CEHRT use as an eligibility requirement for participation in the Shared Savings Program is finalized, we believed this new requirement should replace the current ACO quality measure that assesses the Use of Certified EHR Technology (ACO-11). We explained that the proposed new eligibility requirement, which would be assessed through the application process and annual certification, would help to meet the goals of the program and align with the approach used in other MIPS APMs. Moreover, the proposed new requirement would render reporting on the Use of Certified EHR Technology quality measure unnecessary in order for otherwise eligible tracks (and payment models within tracks) to meet the Advanced APM criterion regarding required use of CEHRT under § 414.1415(a)(1)(i). As a result, continuing to require ACOs to report on this measure would impose undue reporting burden on eligible clinicians that meet the QP threshold and would otherwise not be required to report the Promoting Interoperability performance category for purposes of the Quality Payment Program. Therefore, we proposed to remove the Use of Certified EHR Technology measure (ACO-11) from the Shared Savings Program quality measure set, effective with quality reporting for performance years starting on January 1, 2019, and subsequent performance years. We proposed corresponding changes to the regulation at § 425.506. We also reiterated that the removal of the Use of Certified EHR Technology measure (ACO-11) from the quality measure set used under the Shared Savings Program, if finalized, would not affect policies under MIPS for reporting on the Promoting Interoperability performance category and scoring under the APM Scoring Standard for MIPS eligible clinicians in MIPS APMs. In other words, eligible clinicians subject to MIPS (such as eligible clinicians in the proposed BASIC track, Levels A through D, Track 1, and other MIPS eligible clinicians who are required to report on the Promoting Interoperability performance category for purposes of the Quality Payment Program) would continue to report as usual on the Promoting Interoperability performance category. However, data reported for purposes of the Promoting Interoperability performance category under MIPS would not be used to assess the ACO's quality performance under the Shared Savings Program. We welcomed public comment on the proposal to remove the quality measure on Use of Certified EHR Technology (ACO-11) from the Medicare Shared Savings Program measure set, effective for quality reporting for performance years starting on January 1, 2019, and subsequent performance years.
Finally, as discussed previously in this section, in the CY 2017 Quality Payment Program final rule, CMS finalized a separate Advanced APM CEHRT use criterion that applies for the Shared Savings Program at § 414.1415(a)(1)(ii). To meet the Advanced APM CEHRT use criterion under the Shared Savings Program, a penalty or reward must be applied to an APM Entity based upon the degree of CEHRT use among its eligible clinicians. We believed that this alternative criterion was appropriate to assess the Advanced APM CEHRT use requirement under the Shared Savings Program because, at the time, a specific level of CEHRT use was not required for participation in the program (81 FR 77412).
As we explained in the August 2018 proposed rule (83 FR 41911), our proposal to impose specific CEHRT use requirements on ACOs participating in the Shared Savings Program would eliminate the need for the separate CEHRT use criterion applicable to the Shared Savings Program APMs found at § 414.1415(a)(1)(ii). We noted that if the proposal to incorporate specific requirements regarding the use of CEHRT by Shared Savings Program ACOs were finalized, ACOs seeking to participate in a Shared Savings Program track (or payment model within a track) that meets the financial risk standard to be an Advanced APM would be required to demonstrate that the percentage of eligible clinicians in the ACO using CEHRT to document and communicate clinical care to their patients or other health care providers meets or exceeds the higher of 50 percent or the percentage specified in the CEHRT use criterion for Advanced APMs at § 414.1415(a)(1)(i). As a result, a separate CEHRT use criterion for APMs under the Shared Savings Program would no longer be necessary.
Therefore, we proposed to revise the separate Shared Savings Program CEHRT use criterion at § 414.1415(a)(1)(ii) so that it would apply only for QP Performance Periods under the Quality Payment Program prior to 2019. We sought comment on this proposal.
Based on the comments received in response to the proposals in the August 2018 proposed rule and our desire to align with the Quality Payment Program, under which eligible clinicians must certify regarding their CEHRT use by the last day of the reporting period, we are not finalizing our proposal to require ACOs to certify at the time of application that they meet the applicable CEHRT requirements. However, we are finalizing our proposal to require ACOs to certify annually that the percentage of eligible clinicians participating in the ACO that use CEHRT to document and communicate clinical care to their patients or other health care providers meets or exceeds the applicable percentage during the current performance year. ACOs will be required to submit this certification in the form and manner specified by CMS for performance years starting on January 1, 2019, and all subsequent performance years. For performance years starting on January 1, 2019, the annual certification will occur in the spring of 2019 for ACOs extending their participation agreement for 6 months, and in the fall of 2019 for ACOs that have a 12-month performance year during 2019. We believe this final policy is not only responsive to commenters' concerns regarding the timing of the certification but also enables timely implementation of the requirement starting in 2019. As noted above, a majority of commenters supported our proposal to replace ACO-11—Use of Certified EHR Technology with a requirement that ACOs certify regarding the percentage of eligible clinicians participating in the ACO that use CEHRT to document and communicate clinical care to their patients or other health care providers starting January 1, 2019. We also note that this new requirement aligns more closely with the requirements regarding CEHRT use imposed under the Next Generation ACO Model, which requires that participating ACOs certify compliance with the CEHRT use requirement in the fall of each performance year. As stated in the August 2018 proposed rule, we currently require that ACOs must have in place at the time of application a written plan to use enabling technologies, such as electronic health records and other health IT tools, to coordinate care (§ 425.112(b)(4)(i)(C)). Because this policy is already in place, we believe that our decision not to finalize the proposal to require ACOs to certify with respect to their use of CEHRT at time of application to the Shared Savings Program will not undermine the policies under the program designated to promote and encourage the use of CEHRT.
Although the comments requesting clarification of our CEHRT proposals were not specific regarding the Shared Savings Program track for which they were seeking clarification, in this final rule we are clarifying the CEHRT threshold requirement for ACOs participating in an Advanced APM. Our intent at the time we proposed this policy was to preserve a minimum threshold of 50 percent CEHRT use for all ACOs in the Shared Savings Program, even if the requirement at § 414.1415(a)(1)(i) were revised through future rulemaking to be below 50 percent. However, we now recognize that this proposed “higher of” policy generated undue complexity. In the unlikely event that the requirement for CEHRT use at § 414.1415(a)(1)(i) were to be reduced to below 50 percent in the future, we would have the opportunity
We received no comments on our proposals to change the regulation at § 425.204(c) to establish the new application requirement and the regulation at § 425.302(a)(3)(iii) to establish the new annual certification requirement. We also received no comments on our proposal to amend § 425.20 to incorporate a definition of “CEHRT” consistent with the definition at § 414.1305, including any subsequent updates or revisions to that definition, and to incorporate the definition of “eligible clinician” at § 414.1305 that applies under the Quality Payment Program. In addition, we received no comments on our proposal to amend the separate Shared Savings Program CEHRT use criterion at § 414.1415(a)(1)(ii) so that it applies only for QP Performance Periods under the Quality Payment Program prior to 2019. Furthermore, we received no comments on our proposal to add a new provision to the regulation at § 425.506 to establish the CEHRT requirement for performance years starting on January 1, 2019, and subsequent performance years for ACOs in a track or payment model within a track that does not meet the financial risk standard to be an Advanced APM and ACOs in a track or payment model within a track that meets the financial risk standard to be an Advanced APM.
After considering the comments received, we are finalizing with modification our proposal that for performance years starting on January 1, 2019, and subsequent performance years, ACOs in a track that does not meet the financial risk standard to be an Advanced APM must certify that at least 50 percent of the eligible clinicians participating in the ACO use CEHRT to document and communicate clinical care to their patients or other health care providers. Specifically, we are finalizing
Similarly, after considering the comments received, we are also finalizing with modification our proposal with respect to ACOs in Shared Savings Program tracks that meet the financial risk standard to be an Advanced APM. We proposed that these ACOs would be required to certify at the time of application and annually thereafter that they meet the higher of the 50 percent threshold proposed for ACOs in a track that does not meet the financial risk to be an advanced APM or the CEHRT use criterion for Advanced APMs under the Quality Payment Program at § 414.1415(a)(1)(i).
For the reasons discussed previously, we not finalizing the requirement that ACOs certify that they meet the higher of the 50 percent threshold or the applicable threshold under the Quality Payment Program. Rather, ACOs will be required to certify only that they meet the applicable threshold established under the Quality Payment Program. In addition, as also discussed, we are not finalizing our proposal that ACOs certify that they meet the CEHRT requirement at the time of application. Accordingly, for performance years starting on January 1, 2019, and subsequent years, ACOs in a track that meets the financial risk standard to be an Advanced APM must certify annually that the percentage of eligible clinicians participating in the ACO that use CEHRT to document and communicate clinical care to their patients or other health care providers meets or exceeds the threshold established under the Quality Payment Program at § 414.1415(a)(1)(i).
We are finalizing the proposed new provision at § 425.506(f) with conforming modifications to reflect the policies we are finalizing in this final rule. As part of these modifications, we are omitting the reference to “a payment model within a track” because we are not addressing the proposal to create the BASIC track, with separate payment models at Levels A through E, at this time. We anticipate summarizing and responding to comments received on this proposal and other proposals related to the participation options under the Shared Savings Program in a forthcoming final rule. For the reasons discussed previously in this section, we are not finalizing the proposed changes to the regulation at § 425.204(c) to establish the new application requirement; but, we are finalizing the proposed changes to the regulation at § 425.302(a)(3)(iii) to establish the new annual certification requirement. In addition, we are finalizing our proposed amendments to § 425.20 to incorporate a definition of “CEHRT” consistent with the definition at § 414.1305, including any subsequent updates or revisions to that definition, and to incorporate the definition of “eligible clinician” at § 414.1305 that applies under the Quality Payment Program. We are also finalizing our proposal to amend the separate Shared Savings Program CEHRT use criterion at § 414.1415(a)(1)(ii) so that it applies only for QP Performance Periods under the Quality Payment Program prior to 2019.
As noted in the August 2018 proposed rule (83 FR 41910), CMS reserves the right to monitor, assess, and/or audit an ACO's compliance with respect to its certification of CEHRT use among its participating eligible clinicians, consistent with §§ 425.314 and 425.316, and to take compliance actions (including warning letters, corrective action plans, and termination) as set forth at §§ 425.216 and 425.218 when ACOs fail to meet or exceed the required CEHRT use thresholds.
Finally, after considering the comments received in response to the proposal to remove ACO-11: Use of Certified EHR Technology measure from the Shared Savings Program quality measure set, we are finalizing our proposal effective with quality reporting for performance years starting on January 1, 2019, and subsequent performance years. We are also finalizing the corresponding revisions to the regulation at § 425.506 to reflect this change.
In the August 2018 proposed rule (83 FR 41912), we discussed the applicability of proposed policies to Track 1+ Model ACOs. We explained that the Track 1+ Model was established under the Innovation Center's authority at section 1115A of the Act, to test innovative payment and service delivery models to reduce program expenditures while preserving or enhancing the quality of care for Medicare, Medicaid, and Children's Health Insurance Program beneficiaries. We noted that 55 Shared Savings Program Track 1 ACOs entered into the Track 1+ Model beginning on January 1, 2018. This includes 35 ACOs that entered the model within their current agreement period (to complete the remainder of their agreement period under the model) and 20 ACOs that entered into a new 3-year agreement period under the model.
To enter the Track 1+ Model, ACOs must be approved to participate in the model and are required to agree to the terms and conditions of the model by executing a Track 1+ Model Participation Agreement available at
We explained that, unless stated otherwise in the Track 1+ Model Participation Agreement, the requirements of the Shared Savings Program under 42 CFR part 425 continue to apply. Consistent with § 425.212, Track 1+ Model ACOs are subject to all applicable regulatory changes, including but not limited to changes to the regulatory provisions referenced within the Track 1+ Model Participation Agreement, that become effective during the term of the ACO's Shared Savings Program Participation Agreement and Track 1+ Model
In the August 2018 proposed rule (83 FR 41912 through 41913), we discussed the unavailability of application cycles for entry into the Track 1+ Model in 2019 and 2020. We explained that an ACO's opportunity to join the Track 1+ Model aligns with the Shared Savings Program's application cycle. The original design of the Track 1+ Model included 3 application cycles for ACOs to apply to enter or, if eligible and if applicable, to renew their participation in the Track 1+ Model for an agreement period start date of 2018, 2019, or 2020. The 2018 application cycle is closed, and as discussed elsewhere in the August 2018 proposed rule, 55 ACOs began participating in the Track 1+ Model on January 1, 2018. As discussed in section II.A.7 of the August 2018 proposed rule (83 FR 41847) and section V.B.1.a of this final rule, we are not offering an application cycle for a January 1, 2019 start date for new agreement periods under the Shared Savings Program. Therefore, we similarly are not offering a start date of January 1, 2019, for participation in the Track 1+ Model.
We explained that existing Track 1+ Model ACOs would be able to complete the remainder of their current agreement period in the model. Additionally, as discussed in section II.A.7.c.(1) of the August 2018 proposed rule (83 FR 41854 through 41855) and section V.B.1.c.(1) of this final rule, ACOs currently participating in the Track 1+ Model will not have the opportunity to apply to use a SNF 3-day rule waiver starting on January 1, 2019, under our decision to forgo an annual application cycle for a January 1, 2019 start date in the Shared Savings Program. We proposed that, if finalized, the next available application cycle for a SNF 3-day rule waiver would occur in advance of a July 1, 2019 start date. We will address proposals related to future application cycles in subsequent rulemaking.
In section II.F of the August 2018 proposed rule (83 FR 41913 through 41914), we provided a comprehensive discussion of the applicability of the proposed policies to Track 1+ Model ACOs to allow these ACOs to better prepare for their future years of participation in the program and the Track 1+ Model. We explained that there are two ways in which the proposed policies would become applicable to Track 1+ Model ACOs: (1) Through revisions to existing regulations that currently apply to Track 1+ Model ACOs; and (2) through revisions to the ACO's Track 1+ Model Participation Agreement.
We sought comment on these considerations, and any other issues that we may not have discussed related to the effect of the proposed policies on ACOs that entered the Track 1+ Model beginning in 2018. We note that these ACOs will complete their participation in the Track 1+ Model by no later than December 31, 2020 (for ACOs that entered the model at the start of a 3-year agreement period), or sooner in the case of ACOs that entered the model at the start of their second or third performance year within their current 3-year agreement period.
Generally, comments regarding the application of specific proposals to Track 1+ Model ACOs have been addressed as part of the discussion of comments in the relevant section of this final rule. Accordingly, in this section of this final rule, we are not repeating comments related to the applicability of the proposed policies to ACOs participating in the Track 1+ Model.
Therefore, unless specified otherwise, the changes to the program's regulations finalized in this final rule that are applicable to Shared Savings Program ACOs within a current agreement period will apply to ACOs in the Track 1+ Model in the same way that they apply to ACOs in Track 1, so long as the applicable regulation has not been waived under the Track 1+ Model. Similarly, to the extent that certain requirements of the regulations that apply to ACOs under Track 2 or Track 3 have been incorporated for ACOs in the Track 1+ Model under the terms of the Track 1+ Model Participation Agreement, changes to the regulations as finalized in this final rule will also apply to ACOs in the Track 1+ Model in the same way that they apply to ACOs in Track 2 or Track 3. For example, the following policies apply to Track 1+ Model ACOs:
• Revisions to voluntary alignment policies (section V.B.2.b. of this final rule), applicable for the performance year beginning on January 1, 2019, and subsequent performance years.
• Revisions to the definition of primary care services used in beneficiary assignment (section V.B.2.c. of this final rule), applicable for the performance year beginning on January 1, 2019, and subsequent performance years.
• Discontinuation of quality measure ACO-11; requirement to attest as part of the annual certification that a specified percentage of the ACO's eligible clinicians use CEHRT (section V.B.2.f. of this final rule), applicable for the performance year beginning on January 1, 2019, and subsequent performance years.
We will also apply the following policies finalized in this final rule to Track 1+ Model ACOs through an amendment to the Track 1+ Model Participation Agreement executed by CMS and the ACO:
• Annual certification that the percentage of eligible clinicians participating in the ACO that use CEHRT to document and communicate clinical care to their patients or other health care providers meets or exceeds the threshold established under § 414.1415(a)(1)(i) (section V.B.2.f. of this final rule). This certification is required to ensure the Track 1+ Model continues to meet the CEHRT criterion to qualify as an Advanced APM for purposes of the Quality Payment Program.
• For ACOs that started a first or second Shared Savings Program participation agreement on January 1, 2016, and entered the Track 1+ Model on January 1, 2018, and that elect to extend their Shared Savings Program participation agreement for the 6-month performance year from January 1, 2019 through June 30, 2019 (as described in section V.B.1 of this final rule):
++ As described in section V.B.1.c.(3) of this final rule, the ACO should extend its repayment mechanism so that it remains in effect for 24 months after the end of the agreement period (June 30, 2021).
++ As described in section V.B.1.c.(10) of this final rule, the ACO is eligible for shared savings if the following conditions are met: The ACO completed the 6-month performance year starting on January 1, 2019; the ACO has completed all close-out procedures specified in § 425.221(a) by the deadline specified by CMS (if applicable); and the ACO has satisfied
++ We will determine performance for the 6-month performance year from January 1, 2019 through June 30, 2019, according to the approach specified in a new section of the regulations at § 425.609(b), applying the financial methodology for calculating shared losses specified in the ACO's Track 1+ Model Participation Agreement.
++ We will continue to share aggregate report data with the ACO for the entire CY 2019, consistent with the approach described in section V.B.1.c.(8) of this final rule, and the terms of the ACO's Track 1+ Model Participation Agreement.
• Extreme and uncontrollable circumstances policies for determining shared losses for performance years 2018 and subsequent years, consistent with the policies specified in § 425.610(i) (section V.B.2.d. of this final rule) and, for ACOs that elect to extend their Shared Savings Program participation agreement for the 6-month performance year from January 1, 2019 through June 30, 2019, in § 425.609(d) (section V.B.1.c.(5) of this final rule).
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. chapter 35), we are required to publish a 30-day notice in the
We solicited comments in the notice of proposed rulemaking that published in the July 27, 2018
To derive average costs, we used data from the U.S. Bureau of Labor Statistics' May 2017 National Occupational Employment and Wage Estimates for all salary estimates (
As indicated, we adjusted 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, we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method.
Section 1834A of the Act, as established by section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA), required significant changes to how Medicare pays for clinical diagnostic laboratory test (CDLTs) under the CLFS. The CLFS final rule, titled “Medicare Clinical Diagnostic Laboratory Tests Payment System Final Rule” (CLFS final rule), was published in the
An applicable laboratory is defined at § 414.502, in part, as an entity that is a laboratory (as defined under the Clinical Laboratory Improvement Amendments (CLIA) definition at § 493.2) that bills Medicare Part B under its own National Provider Identifier (NPI). In addition, an applicable laboratory is an entity that receives more than 50 percent of its Medicare revenues during a data collection period from the CLFS and/or the PFS. We refer to this component of the applicable laboratory definition as the “majority of Medicare revenues threshold.” The definition of applicable laboratory also includes a “low expenditure threshold” component, which requires an entity to receive at least $12,500 of its Medicare revenues
In determining payment rates under the private payor rate-based CLFS, one of our goals is to obtain as much applicable information as possible from the broadest possible representation of the national laboratory market on which to base CLFS payment amounts, for example, from independent laboratories, hospital outreach laboratories, and physician office laboratories, without imposing undue burden on those entities. We believe it is important to achieve a balance between collecting sufficient data to calculate a weighted median that appropriately reflects the private market rate for a CDLT, and minimizing the reporting burden for entities. In response to stakeholder feedback in the proposed rule (see section III.A.3 of this final rule for a discussion of this feedback) and in the interest of facilitating our goal, we are finalizing the revision to the majority of Medicare revenues threshold component of the definition of applicable laboratory at § 414.502(3) to exclude Medicare Advantage (MA) payments under Medicare Part C from the definition of total Medicare revenues (that is, the denominator of the majority of Medicare threshold equation). Specifically, this revision could allow additional laboratories of all types serving a significant population of beneficiaries enrolled in Medicare Part C to meet the majority of Medicare revenues threshold and potentially qualify as applicable laboratories (provided they meet all other requirements for applicable laboratory status) and report data to us.
In addition, in response to stakeholder feedback (see section III.A.4 of this final rule for a discussion of this feedback) in response to the comment solicitation in the proposed rule and in the interest of obtaining as much applicable information as possible, we are finalizing a revision to the definition of applicable laboratory at § 414.502 to include a hospital that bills Medicare on the Form CMS-1450 14x Type of Bill (OMB control number: 0938-0997) and its electronic equivalent.
As such, we believe the finalized changes may result in more applicable information being reported, which we will use to set CLFS payment rates. However, with regard to the CLFS-related requirements and burden, as we noted in the proposed rule, section 1834A(h)(2) of the Act provides that the Paperwork Reduction Act in chapter 35 of title 44 of the U.S.C. shall
For a complete discussion of our finalized revisions to the definition of applicable laboratory in § 414.502 related to the majority of Medicare revenues threshold and use of the Form CMS-1450 14X TOB, we refer readers to sections III.A.4.a of this final rule.
General practitioners make up a large group of practitioners who order applicable imaging services and will be required to consult AUC under this program so we use “family and general practitioner” from the list of BLS occupation titles (see Table 60) to calculate the following cost estimates. While we proposed to modify the consultation requirement to allow auxiliary personnel, working under the direction of the ordering professional, to interact with the CDSM for AUC consultation, in this final rule we changed this estimate from using the “registered nurse” occupation to using the “medical assistant” occupation to calculate our revised cost estimates for our final policy to allow clinical staff acting under the direction of the ordering professional to perform the AUC consultation.
To derive the burden associated with the requirements under § 414.94(j), we estimate it will take 2 minutes (0.033 hr) at $70.72/hr for auxiliary personnel in the form of a registered nurse to consult with a qualified CDSM. The Medicare Benefit Policy Manual (Pub. 100-02), Chapter 15, Section 60.2 IOM 100-02, requires that an incidental service performed by the nonphysician practitioner must have followed from a direct, personal, professional service furnished by the physician. Therefore, to estimate the percentage of consultations available to be performed incident to, we analyzed 2014 Medicare Part B claims comparing evaluation and management visits for new (CPT codes 99201, 99202, 99203, 99204, and 99205) relative to established (CPT codes 99211, 99212, 99213, 99214, 99215) patients with place of service codes 11 (physician's office). We found that approximately 10 percent of all claims incurred were for new patients. Therefore, we also estimate that 90 percent or 38,863,636 of the total consultations (43,181,818 total consultations × 0.90) will be performed by such auxiliary personnel, with the remaining 10 percent (43,181,818 × 0.10) performed by the ordering professional. In this final rule and after review of public comments (see below), we revised § 414.94(j) to allow ordering professionals to delegate the AUC consultation to clinical staff acting under the direction of the ordering professional. To reflect this change, we updated our burden estimates to reflect the final policy and revised our estimates to replace a registered nurse with medical assistant to perform the AUC consultation. In aggregate, we estimate an annual burden of 1,282,500 hours (38,863,636.2 consultations × 0.033 hr/consultation) at a cost of $41,424,750 (1,282,500 hr × $32.30/hr) or $1.07 per consultation performed by clinical staff under the direction of the ordering professional. We will continue to monitor our burden estimates and, if necessary, adjust them for more precision once the program begins.
Additionally, the CY 2018 Physician Fee Schedule final rule (82 FR 52976) explicitly discussed and provided a voluntary period for ordering professionals to begin to familiarize themselves with qualified CDSMs. During the current 18-month voluntary participation period, we estimate there may be 10,230,000 consultations based on market research from current applicants for the qualification of their CDSMs for advanced diagnostic imaging services. Based on feedback from CDSMs with experience in AUC consultation, as well as standards recommended by the Office of the National Coordinator (ONC)
Beginning January 1, 2020, we anticipate 43,181,818 responses in the form of consultations based on the aforementioned market research, as well as Medicare claims data for advanced diagnostic imaging services. As noted earlier, we estimate it will take 2 minutes (0.033 hr) at $200.54/hr for a family and general practitioner or 2 minutes at $32.30/hr for a medical assistant to use a qualified CDSM to consult specified applicable AUC. In aggregate, we estimate an annual burden of 1,425,000 hours (43,181,818 consultations × 0.033 hr/consultation) at a cost of $70,001,700 ([0.1 × 1,425,000 hr × $200.54/hr] + [0.9 × 1,425,000 hr × $32.30/hr]).
The following is a summary of the comments we received regarding these burden estimates.
After considering the comments, we are updating the proposed impact estimate of consultations by ordering professionals. First, we modified our calculation of the effort by a registered nurse to the effort of a 2-minute consultation with a qualified CDSM by a medical assistant (occupation code 31-9092) with mean hourly wage of $16.15 and 100 percent fringe benefits for 90 percent of consultations (1,282,500 hours) to be $41,424,750 (1,282,500 hours × $32.30/hour). Consequently, we have updated our estimated total burden during the voluntary period to 337,590 hours (10,230,000 consultations × 0.033 hr) at a cost of $16,583,771.16 ([337,590 hr × 0.10 × $200.54/hr] + [337,590 hr × 0.90 × $32.30/hr]). Annually, this estimate represents 112,530 hours (337,590 hr/3 yr) at a cost of $5,527,923.72 ($16,583,771.16/3 yr). Additionally, we update our aggregate estimate of annual burden beginning January 1, 2020 of 1,425,000 hours (43,181,818 consultations × 0.033 hr/consultation) at a cost of $70,001,700 ([0.1 × 1,425,000 hr × $200.54/hr] + [0.9 × 1,425,000 hr × $32.30/hr]).
Section 1899(e) of the Act provides that chapter 35 of title 44 of the U.S. Code, which includes such provisions as the PRA, shall not apply to the Shared Savings Program.
Section 1877 of the Act, also known as the physician self-referral law: (1) Prohibits a physician from making referrals for certain designated health services (DHS) payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship (ownership or compensation), unless an exception applies; and (2) prohibits the entity from filing claims with Medicare (or billing another individual, entity, or third party payer) for those referred services. The statute establishes a number of specific exceptions, and grants the Secretary the authority to create regulatory exceptions for financial relationships that pose no risk of program or patient abuse. Additionally, the statute mandates refunding any amount collected under a bill for an item or service furnished under a prohibited referral. Finally, the statute imposes reporting requirements and provides for sanctions, including civil monetary penalty provisions.
As discussed in section III.G. of this rule, we are finalizing regulatory updates to implement section 50404 of the Bipartisan Budget Act of 2018 (Pub. L. 115-123, enacted February 9, 2018), which added provisions to section 1877(h)(1) of the Act pertaining to the writing and signature requirements in certain compensation arrangement exceptions to the physician self-referral law's referral and billing prohibitions. Although we believe that the newly enacted provisions in section 1877(h)(1) of the Act are principally intended merely to codify in statute existing CMS policy and regulations with respect to compliance with the writing and signature requirements, we are finalizing revisions to our regulations at 42 CFR 411.354(e) and 411.353(g) to address any actual or perceived difference between the statutory and regulatory language, to codify in regulation our longstanding policy regarding satisfaction of the writing requirement found in many of the exceptions to the physician self-referral law, and to make the Bipartisan Budget Act of 2018 policies applicable to compensation arrangement exceptions issued using the Secretary's authority in section 1877(b)(4) of the Act. The burden associated with the writing and signature requirements is the time and effort necessary to prepare written documents and obtain signatures of the parties.
Although the writing and signature requirements are subject to the PRA, we believe the associated burden is exempt under 5 CFR 1320.3(b)(2). We believe that the time, effort, and financial resources necessary to comply with the writing and signature requirements will be incurred by persons during the normal course of their activities and in the absence of federal regulation. Specifically, we believe that, for normal business operations purposes, health care providers and suppliers document their financial arrangements with physicians and others in order to identify and be able to enforce the legal obligations of the parties. Therefore, we believe that the writing and signature requirements should be considered usual and customary business practices.
We did not receive any public comments regarding our position that the burden associated with these requirements is a usual and customary business practice that is exempt from the PRA.
The following ICRs reflect this final rule's policies, as well as policies in the CY 2017 (81 FR 77008) and CY 2018 (82 FR 53568) Quality Payment Program final rules. In discussing each ICR, we reference the specific policies and whether they are finalized in this final rule or finalized in the CY 2017 or CY 2018 Quality Payment Program final rules. As described in this section in more detail, three ICRs (Quality: CMS Web Interface, Promoting Interoperability Performance Category: Data Submission, and Voluntary Participants Election to Opt-Out of Performance Data Display on Physician Compare) show a reduction in burden due to changes in policies that we are finalizing in this final rule. Most of the burden estimates discussed in this section are reductions in burden compared to currently approved estimates and reflect adjustments due to the use of data from the 2017 MIPS performance period or revised per-respondent burden assumptions. Finally, we added one ICR to incorporate a collection previously mentioned in the CY 2018 Quality
The revised requirements and burden estimates for all Quality Payment Program ICRs (except for CAHPS for MIPS and virtual groups election) will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). The revised CAHPS for MIPS ICRs will be submitted to OMB for approval under control number 0938-1222 (CMS-10450). The Virtual Groups Election is approved under OMB control number 0938-1343 (CMS-10652).
With regard to Quality Payment Program respondents, we selected BLS occupations Billing and Postal Clerks, Computer Systems Analysts, Physicians, Practice Administrator, and Licensed Practical Nurse (see Wage Estimates in section V.A. of this final rule) based on a study (Casalino et al., 2016) that collected data on the staff in physician's practices involved in the quality data submission process.
Respondent estimates for the quality, Promoting Interoperability, and improvement activities performance categories are modeled using data from the 2017 MIPS performance period with the sole exception of 286 CMS Web Interface respondents, which is based on the number of groups who registered for using the CMS Web Interface during the 2018 MIPS performance period.
As discussed in section III.I.3.a. of this final rule, we are finalizing with modification our proposal to expand MIPS to additional clinician types starting with the 2019 MIPS performance period/2021 MIPS payment year; these new clinician types include physical therapists, occupational therapists, qualified speech-language pathologists, qualified audiologists, clinical psychologists, and registered dieticians or nutrition professionals. In addition, in section III.I.3.c. of this final rule, we are finalizing the low-volume threshold in the following manner: If a MIPS eligible clinician meets or exceeds one, but not all, of the low-volume threshold criterion, including as defined by dollar amount ($90,000), beneficiary count (200), or covered professional services to Part-B enrolled individuals (minimum threshold of 200) then the clinician may elect to submit data and opt-in to MIPS. If a MIPS eligible clinician does not meet at least one of these low-volume determinations or meets at least one, but not all, of these low-volume determinations and elects not to opt-in, the clinician is not eligible and is excluded from MIPS. If the clinician is excluded and submits data, the clinician will be a voluntary reporter. These policies will expand the number of potential MIPS eligible clinicians, but we do not anticipate an incremental increase in the burden because the affected clinicians were assumed to be voluntary reporters in prior rules. In the CY 2018 Quality Payment Program final rule, clinicians who participated in 2016 PQRS, and who were not determined to be QPs based on their participation in Advanced APMs during CY 2017 and were not MIPS eligible, were assumed to be voluntary reporters in MIPS (82 FR 53908) with their burden accounted for within our estimates. Therefore, the finalized expansion in MIPS eligibility does not change the total number of respondents, but instead shifts a certain number of assumed voluntary reporters to MIPS eligible clinicians. Additionally, clinicians or groups agreeing to opt-in or voluntarily report will simply select the option of opt-in participation or to remain excluded and voluntarily report prior to submitting data; therefore, we do not believe a commensurate revision to the burden hours is necessary for any of our burden estimates. We realize that clinicians or groups in small practices who submit quality data via Medicare Part B claims do not have to log in the Quality Payment Program portal to submit data; however, we assume the clinicians or groups electing to opt-in would also submit data for the improvement activities performance category as well. Therefore, the effort to elect to opt-in is included in the burden estimate for the improvement activities performance category. We also note that third party intermediaries can be authorized to communicate this opt-in on behalf of clinicians.
Our participation estimates are reflected in Tables 64, 65, and 66 for the quality performance category, Table 77 for the Promoting Interoperability performance category, and Table 79 for the improvement activities performance category.
Due to data limitations, our burden estimates may overstate the total burden for data submission under the quality, Promoting Interoperability, and improvement activities performance categories. This is due to two primary reasons. First, we anticipate the number of QPs to increase because of total expected growth in Advanced APM participation. The additional QPs will be excluded from MIPS and likely not report. Second, it is difficult to predict what eligible clinicians who may report voluntarily will do in the 2019 MIPS performance period compared to the 2017 MIPS performance period and, therefore, the actual number of participants and how they elect to submit data may be different than our estimates. However, we believe our estimates are the most appropriate given the available data.
The following is a summary of general public comments received regarding our request for comment on our information collections and our responses. We received several general comments regarding the burden of data collection associated with the Quality Payment Program.
After consideration of the public comments, we are not making any changes to our burden estimate methodology, but have updated the burden estimates to reflect the availability of participation data from the 2017 MIPS performance period.
For MIPS eligible clinicians participating in MIPS APMs, the organizations submitting data on behalf of MIPS eligible clinicians will vary between performance categories and, in some instances, between MIPS APMs. For the 2019 MIPS performance period, the quality data submitted by Shared Savings Program ACOs, Next Generation ACOs, and other APM Entities on behalf of their participant MIPS eligible clinicians will fulfill any MIPS submission requirements for the quality performance category.
For the Promoting Interoperability performance category, group TINs may submit data on behalf of eligible clinicians in MIPS APMs, or eligible clinicians in MIPS APMs may submit data individually. 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 that for MIPS APMs, 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). Although the policy allows for the submission of additional improvement activities if a MIPS APM receives less than the maximum improvement activities performance category score, to date all MIPS APM have qualified for the maximum improvement activities score. Therefore, we assume that no additional submission will be needed.
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 the CY 2018 Quality Payment Program final rule (82 FR 53841 through 53844), but other than the election to participate in MIPS, we do not have data to estimate that burden.
The policies finalized in the CY 2017 and the CY 2018 Quality Payment Program final rules and this final rule create some additional data collection requirements not listed in Table 61. These additional data collections, some of which were previously approved by OMB under the control numbers 0938-1314 (Quality Payment Program) and 0938-1222 (CAHPS for MIPS), are as follows:
• Self-nomination of new and returning QCDRs (81 FR 77507 through 77508 and 82 FR 53906 through 53908) (OMB 0938-1314).
• Self-nomination of new and returning registries (81 FR 77507 through 77508 and 82 FR 53906 through 53908) (OMB 0938-1314).
• Approval process for new and returning CAHPS for MIPS survey vendors (82 FR 53908) (OMB 0938-1222).
• CAHPS for MIPS survey completion by beneficiaries (81 FR 77509 and 82 FR 53916 through 53917) (OMB 0938-1222).
• Quality Payment Program Identity Management Application Process (82 FR 53914).
• Reweighting Applications for Promoting Interoperability and other performance categories (82 FR 53918) (OMB 0938-1314).
• Nomination of improvement activities (82 FR 53922) (OMB 0938-1314).
• Call for new Promoting Interoperability measures (OMB 0938-1314).
• Call for new quality measures (OMB 0938-1314).
• Opt out of performance data display on Physician Compare for voluntary reporters under MIPS (82 FR 53924 through 53925) (OMB 0938-1314).
• Partial QP Election (81 FR 77512 through 77513 and 82 FR 53922 through 53923) (OMB 0938-1314).
• Other Payer Advanced APM determinations: Payer Initiated Process (82 FR 53923 through 53924) (OMB 0938-1314).
• Other Payer Advanced APM determinations: Eligible Clinician Initiated Process (82 FR 53924) (OMB 0938-1314).
• Submission of Data for All-Payer QP Determinations (New data collection for the 2019 performance period) (OMB 0938-1314).
This final rule does not include any new or revised reporting, recordkeeping, or third-party disclosure requirements related to the virtual group election. The virtual group election requirements and burden are currently approved by OMB under control number 0938-1343 (CMS-10652). Consequently, we have not made any virtual group election changes under that control number.
Under MIPS, the quality, Promoting Interoperability, and improvement activities performance category data may be submitted via relevant third-party intermediaries, such as qualified registries, QCDRs, and health IT vendors. Data on the CAHPS for MIPS survey, which counts as one quality performance category measure, or can be used for completion of an improvement activity, can be submitted via CMS-approved survey vendors. In the CY 2018 Quality Payment Program final rule, we combined the burden for self-nomination of qualified registries and QCDRs (82 FR 53906). For this final rule, we determined that requirements for self-nomination for qualified registries were sufficiently different from QCDRs that it is necessary to estimate the two independently. The change will align the burden more closely to the requirements for QCDRs and qualified registries to self-nominate, not because of any change in policy in this final rule, but because of changes in our initial assumptions. Specifically, while the processes for self-nomination are similar, QCDRs have the option to submit QCDR measures for the quality performance category. Therefore, differences between QCDRs and registries self-nomination are associated with the preparation of QCDR measures for approval. The burden associated with qualified registry self-nomination, QCDR self-nomination, and the CAHPS for MIPS survey vendor applications follow:
Qualified registries interested in submitting MIPS data to us on their participants' behalf need to complete a self-nomination process to be considered qualified to submit on behalf of MIPS eligible clinicians or groups (82 FR 53815).
In the CY 2018 Quality Payment Program final rule, previously approved 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 (82 FR 53815). In the same rule, 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 (82 FR 53815). This simplified self-nomination process will begin for the 2019 MIPS performance period.
The CY 2017 Quality Payment Program final rule provided the definition of a qualified registry to be a medical registry, a maintenance of certification program operated by a specialty body of the American Board of Medical Specialties or other data intermediary that, with respect to a particular performance period, has self-nominated and successfully completed a vetting process (as specified by CMS) to demonstrate its compliance with the MIPS qualification criteria specified by CMS for that performance period (81 FR 77382).
For this final rule, we have adjusted the number of respondents (from 120 to 150) based on more recent data and a revised definition of “respondent” to account for self-nomination applications received but not approved. We have also adjusted our per respondent time estimate (from 10 hours to 3 hours) based on our review of the current burden estimates against the existing policy. Finally, we have provided a range of time estimates (from 10 hours to 0.5 hours) which reflect the availability of a simplified self-nomination process for previously approved qualified registries.
For the 2017 MIPS performance period, we received 138 applications for nomination to be a qualified registry and 145 applications for the 2018 MIPS performance period. In continuance of this trend for the 2019 MIPS performance period, we estimate 150 nomination applications will be received from qualified registries desiring approval to report MIPS data, an increase of 30 respondents from our currently approved estimate.
For this final rule, the burden associated with qualified registry self-nomination will vary depending on the number of existing qualified registries that will elect to use the simplified self-nomination process in lieu of the full self-nomination process as described in the CY 2018 Quality Payment Program final rule (82 FR 53815). The self-nomination form is submitted electronically using the web-based tool JIRA. For the 2018 MIPS performance period, 141 qualified registries were approved to submit MIPS data.
In section III.I.3.k.(3)(a) of this final rule, we have finalized our proposal to modify the definition of a QCDR to be an entity with clinical expertise in medicine and in quality measurement development that collects medical or clinical data on behalf of a MIPS eligible clinician for the purpose of patient and disease tracking to foster improvement in the quality of care provided to patients. This revised definition of a QCDR may result in previously approved QCDRs who no longer meet the new definition to decide to instead seek approval as qualified registries. However, we have not received any notifications of intent and do not have data to support changing our estimate of 150 qualified registries who will submit applications during the self-nomination period for the CY 2020 performance period.
In the CY 2018 Quality Payment Program final rule, we estimated the burden associated with self-nomination of a qualified registry to be 10 hours, similar to PQRS (82 FR 53907). For this final rule, we reduced our estimate to 3 hours because registries no longer provide an XML submission, calculated measure, or measure flow as part of the
For the simplified self-nomination process, we have estimated 0.5 hours per qualified registry to submit a nomination, a reduction of 9.5 hours from currently approved estimates.
As shown in Table 62, we estimate that the staff involved in the qualified registry self-nomination process will be mainly computer systems analysts or their equivalent, who have an adjusted labor cost of $89.18/hour. Assuming that the time associated with the self-nomination process ranges from a minimum of 0.5 hours (for the simplified self-nomination process) to 3 hours (for the full self-nomination process) per qualified registry, we estimate that the annual burden will range from 97.5 hours ([141 qualified registries × 0.5 hr] + [9 qualified registries × 3 hr]) to 450 hours (150 qualified registries × 3 hr) at a cost ranging from $8,695 (97.5 hr × $89.18/hr) to $40,131 (450 hr × $89.18/hr), respectively (see Table 62).
Independent of the change to our per response time estimate, the increase in the number of respondents results in an adjustment of 300 hours and $26,754 (30 registries × 10 hr × $89.18/hr). Accounting for the change in the number of qualified registries, the change in time per qualified registry to self-nominate results in an adjustment of between −1,402.5 hours and −125,075 ([(141 registries × −9.5 hr)] + [(9 registries × −7 hr)] at $89.18/hr) and −1,050 hours and −$93,639 (150 registries × −7 hr × $89.18/hr). When these two adjustments are combined, the net impact ranges between −1,102.5 (−1,402.5 + 300) and −750 (−1,050 + 300) hours and −$98,321 (−$125,075 + $26,754) and −$66,885 (−$93,639 + $26,754).
Qualified registries must comply with requirements on the submission of MIPS data to CMS. The burden associated with the qualified registry submission requirements will be the time and effort associated with calculating quality measure results from the data submitted to the qualified registry by its participants and submitting these results, the numerator and denominator data on quality measures, the Promoting Interoperability performance category, and improvement activities data to us on behalf of their participants. These requirements are currently approved by OMB under control number 0938-1314 (CMS-10621).
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 and the number of applicable measures. However, we believe that qualified registries already perform many of these activities for their participants. We believe the estimates discussed earlier and shown in Table 62 represents the upper bound of registry burden, with the potential for less additional MIPS burden if the registry already provides similar data submission services.
Based on the assumptions previously discussed, we provide an estimate of the total annual burden associated with a qualified registry self-nominating to be considered “qualified” to submit quality measures results and numerator and denominator data on MIPS eligible clinicians.
Both the minimum and maximum burden shown in Table 62 will be submitted for approval to OMB under control number 0938-1314 (CMS-10621) and reflect adjustments due to review of self-nomination process and the number of respondents. For purposes of calculating total burden associated with the final rule as shown in Table 89, only the maximum burden is used.
We received no public comments related to the burden estimates for qualified registry self-nomination. The burden estimates have not been updated from the CY 2019 PFS proposed rule (83 FR 36016 through 36018).
QCDRs interested in submitting quality, Promoting Interoperability, and improvement activities performance category data to us on their participants' behalf will need to complete a self-nomination process to be considered qualified to submit on behalf of MIPS eligible clinicians or groups.
In the CY 2018 Quality Payment Program final rule, previously approved QCDRs 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 (82 FR 53808). Existing QCDRs in good standing that would like to make minimal changes to their previously approved self-nomination application
For this final rule, the burden associated with QCDR self-nomination will vary depending on the number of existing QCDRs that will elect to use the simplified self-nomination process in lieu of the full self-nomination process as described in the CY 2018 Quality Payment Program final rule (82 FR 53808 through 53813). The self-nomination form is submitted electronically using the web-based tool JIRA. For the 2018 MIPS performance period, 150 QCDRs were approved to submit MIPS data.
For this CY 2019 Quality Payment Program final rule, we have adjusted the number of respondents (from 113 to 200) based on more recent data and a revised definition of “respondent” to account for self-nomination applications received but not approved. We have also adjusted the time burden estimates per respondent based on our review of the current burden estimates against the existing policy as well as provided a range of time burden estimates which reflect the availability of a simplified self-nomination process for previously approved QCDRs.
For the 2017 MIPS performance period, we received 138 self-nomination applications from QCDRs and for the 2018 MIPS performance period, we received 176 self-nomination applications. In continuance of this trend for the 2019 MIPS performance period, we estimate 200 self-nomination applications will be received from QCDRs desiring approval to report MIPS data, an increase of 87 respondents.
In section III.I.3.k.(3)(a) of this final rule, we have finalized our proposal to modify the definition of a QCDR to be an entity with clinical expertise in medicine and in quality measurement development that collects medical or clinical data on behalf of a MIPS eligible clinician for the purpose of patient and disease tracking to foster improvement in the quality of care provided to patients. This revised definition of a QCDR may result in previously approved QCDRs who no longer meet the new definition to decide to instead seek approval as qualified registries or collaborate with another previously approved QCDR to meet the requirements of the new definition. However, we have not received any notifications of intent and do not have data to support changing our estimate of 200 QCDRs who will submit applications during the self-nomination period for the CY 2020 performance period. In addition, we have not accounted for any costs associated with QCDRs collaborating to meet the requirements of the new definition as electing to do so would be a business decision made by individual entities which is not required or endorsed by CMS and considering the alternate path of seeking to be a qualified registry would be available for entities seeking to continue participating in MIPS.
We estimate that the self-nomination process for QCDRs to submit on behalf of MIPS eligible clinicians or groups for MIPS will involve approximately 3 hours per QCDR to submit information required at the time of self-nomination as described in the CY 2017 Quality Payment Program final rule including basic information about the QCDR, describing the process it will use for completion of a randomized audit of a subset of data prior to submission, providing a data validation plan, and providing results of the executed data validation plan by May 31 of the year following the performance period (81 FR 77383 through 77384). However, for the simplified self-nomination process, we estimate 0.5 hours per QCDR to submit this information. The aforementioned modification to the definition of a QCDR is not expected to affect the estimated time for submitting the full or simplified self-nomination. The self-nomination form is submitted electronically using the web-based tool JIRA.
In addition, QCDRs calculate their measure results. QCDRs must possess benchmarking capabilities (for QCDR measures) that compare 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, 2017 data for the 2019 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 website 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 QCDR will spend an additional 1 hour performing these activities per measure and assume that each QCDR will submit information for 9 QCDR measures, for a total burden of 9 hours per QCDR (1 hr per measure × 9 measures). The estimated average of 9 measures per QCDR is based on the number of QCDR measure submissions received in the 2017 and 2018 MIPS performance periods and is the same for each QCDR regardless of whether they elect to use the simplified or full self-nomination process.
In the 2017 MIPS performance period, we received over 1,000 QCDR measure submissions. In the 2018 MIPS performance period, we received over 1,400 QCDR measure submissions. For the 2019 MIPS performance period, we anticipate this trend will continue, and therefore, estimate we will receive a total of approximately 1,800 QCDR measure submissions, resulting in an average of 9 measure submissions per QCDR (1,800 measure submissions/200 QCDRs).
In the CY 2018 Quality Payment Program final rule, the burden associated with self-nomination of a QCDR was estimated to be 10 hours (82 FR 53907). For this final rule, we are increasing the burden associated with self-nomination to 12 hours. Because QCDRs are no longer required to provide an XML submission and are not subject to a mandatory interview; both of which were completed as part of the PQRS QCDR self-nomination process upon which the previous assumption of 10 hours was based, we are eliminating 1 hour from our previous burden assumption. Simultaneously, we are increasing our burden assumption by 3 hours to account for an increase in the number of QCDR measure submissions being submitted. These two adjustments result in a net increase of 2 hours per respondent from our previously approved burden estimates.
As shown in Table 63, we estimate that the staff involved in the QCDR self-nomination process will continue to be computer systems analysts or their equivalent, who have an average labor cost of $89.18/hr. Assuming that the hours per QCDR associated with the self-nomination process ranges from a minimum of 9.5 hours (for the simplified self-nomination process) to 12 hours (for the full self-nomination process), we estimate that the annual burden will range from 2,025 hours ([150 QCDRs × 9.5 hr] + [50 QCDRs × 12 hr]) to 2,400 hours (200 QCDRs × 12 hr) at a cost ranging between $180,590 (2,025 hr × $89.18/hr) and $214,032 (2,400 hr × $89.18/hr), respectively (see Table 63).
Independent of the change to our per response time estimate, the increase in the number of respondents results in an
QCDRs must comply with requirements on the submission of MIPS data to CMS. The burden associated with the QCDR submission requirements will be the time and effort associated with calculating quality measure results from the data submitted to the QCDR by its participants and submitting these results, the numerator and denominator data on quality measures, the Promoting Interoperability performance category, and improvement activities data to us on behalf of their participants. These requirements are currently approved by OMB under control number 0938-1314 (CMS-10621). We expect that the time needed for a QCDR to accomplish these tasks will vary along with the number of MIPS eligible clinicians submitting data to the QCDR and the number of applicable measures. However, we believe that 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.
We finalized in the CY 2018 Quality Payment Program final rule that QCDR vendors may seek permission from another QCDR to use an existing measure that is owned by the other QCDR (82 FR 53813). However, some QCDR measure stewards charge a fee for the use of their QCDR measures. We have not accounted for QCDR measure licensing costs as part of our burden estimate due to the election to license a QCDR measure being a business decision made by individual QCDRs which is not required or endorsed by CMS for participation in MIPS.
Based on the assumptions previously discussed, we provide an estimate of the total annual burden associated with a QCDR self-nominating to be considered “qualified” to submit quality measures results and numerator and denominator data on MIPS eligible clinicians.
Both the minimum and maximum burden shown in Table 63 will be submitted for approval to OMB under control number 0938-1314 (CMS-10621) and reflect adjustments due to the review of self-nomination process and the number of respondents. For purposes of calculating total burden associated with the final rule as shown in Table 89, only the maximum burden will be used.
We received no public comments related to the burden estimates for QCDR self-nomination. The burden estimates have not been updated from the CY 2019 PFS proposed rule (83 FR 36018 through 36019), however we have provided additional elaboration on the updated requirements for QCDRs electing to self-nominate and our rationale for why the burden estimates do not require additional revision.
Under our current policies, 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. Although the finalized expansion of the definition of a MIPS eligible clinician to new clinician types and the opt-in process for MIPS participation discussed in sections III.I.3.a and III.I.3.c.(6) of this final rule could affect respondent counts, all of the new potential respondents had the opportunity to participate in PQRS and as a voluntary reporter in MIPS. Therefore, consistent with our assumptions in the CY 2017 and CY 2018 Quality Payment Program final rules that PQRS participants that are not QPs will have participated in MIPS as voluntary respondents (81 FR 77501 and 82 FR 53908, respectively), we anticipate that this rule's finalized expansion of the definition of a MIPS eligible clinician will not have any incremental effect on any of our currently approved burden estimates. For the purpose of the following analyses, we assume that clinicians who participated in MIPS and who are not QPs in Advanced APMs in the 2017 MIPS performance period will continue to submit quality data in the 2019 MIPS performance period. We assume that 100 percent of APM Entities in MIPS APMs will submit quality data to CMS as required under their models. We estimate a total of 964,246 clinicians participated as individuals or groups in the 2017 MIPS performance period; this number differs from the currently approved estimate (OMB 0938-1314, CMS-10621) of 758,267 due to the availability of updated data.
As discussed in section III.I.3.h.(1)(b) of this final rule, we are replacing the term “submission mechanism” with the terms “collection type” and “submission type.” “Submission mechanism” is presently used to refer not only to the mechanism by which data is submitted, but also to certain types of measures and activities on which data are submitted to the entities submitting such data in the Quality Payment Program.
We assume that clinicians and groups will continue to submit quality data for the same collection types they used during the CY 2017 performance period. In addition, we assume that the 80 TINs that elect to form 16 virtual groups will continue to collect and submit MIPS data using the same collection and submission types as they did during the 2017 MIPS performance period, 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 submit to fulfill the requirements of their models. The burden is excluded as sections 1899(e) and 1115A(d)(3) of the Act (42 U.S.C. 1395jjj(e) and 1315a(d)(3), respectively) state the Shared Savings Program and the testing, evaluation, and expansion of Innovation Center models tested under section 1115A of the Act (or section 3021 of the Affordable Care Act) are not subject to the PRA.
Table 64 provides our estimated counts of clinicians that will submit quality performance category data as MIPS individual clinicians or groups in the 2019 MIPS performance period based on data from the 2017 MIPS performance period.
For the 2019 MIPS performance period, respondents will have the option to submit quality performance category data via Medicare Part B claims, direct, and log in and upload submission types, and CMS Web Interface. At the time of the CY 2019 PFS proposed rule, participation data by submission type and user research data to inform burden assumptions was not available to estimate burden by submission type. As a result, we estimate the burden for collecting data via collection type: Claims, QCDR and MIPS CQMs, eCQMs, and the CMS Web Interface. While we have more information about MIPS submissions, for this final rule, we believe it is important to continue to estimate burden by collection type because the public was able to comment on our assumptions using this framework. As we gain more experience with the program, we may revise this approach through future rulemaking.
For the Medicare Part B claims collection type, in section III.I.3.h.(1)(b) of this rule, we finalized limiting the Medicare Part B claims collection type to small practices beginning with the 2021 MIPS payment year and allowing clinicians in small practices to report Medicare Part B claims as a group or as individuals. We assumed in our currently approved burden analysis that any clinician that submits quality data codes to us for the Medicare Part B claims collection type is intending to do so for the Quality Payment Program. We made this assumption originally in the CY 2017 Quality Payment Program final rule to ensure that we fully accounted for any burden that may have resulted from our policies (81 FR 77501 through 77504). In some cases, however, clinicians may be submitting quality data codes not only for the Medicare Part B claims collection type, but also for MIPS CQM and QCDR collection types. Some registries and QCDRs utilize data from claims to populate their datasets when submitting on behalf of clinicians. We are not able to separate out when a clinician submits a quality data code solely for the Medicare Part B claim collection type or when a clinician is also submitting these codes for MIPS CQM or QCDR collection types. In addition, we see a large number of voluntary reporters for the Medicare Part B claims collection type. Approximately 70 percent of the 257,260 clinicians we estimate will submit quality data via Medicare Part B claims (see Table 64) are MIPS eligible clinicians while the other 30 percent are voluntary reporters which means our burden include estimates for a large number of voluntary reporters. Of these clinicians who are not scored as part of an APM, approximately 55 percent are in practices with more than 15 clinicians; however, over 91 percent of the number in practices larger than 15 clinicians are either voluntary reporters, group reporters, or are also reporting quality data through another collection type. Approximately 10,700 individual clinicians in non-small practices are both MIPS eligible and scored based only on Medicare Part B claims data and of these, 52 percent also qualify for facility-based reporting, and therefore, will not be required to submit quality data in order to receive facility-based quality and cost scores. It is unclear why many clinicians are submitting quality data via an alternate collection type, and we currently lack data to accurately estimate both the number of clinicians who will be impacted by these finalized policies and the potential behavioral response of those clinicians who will be required to switch to another collection type. As a result, we will continue using the assumption that all clinicians (except QPs) who submitted data via the Medicare Part B claims collection type in the 2017 MIPS performance period will continue to do so for MIPS in order to avoid overstating the impact of the change. We intend to update this burden estimate with additional data as it becomes available. We solicited comment on potential other assumptions for capturing the Medicare Part B claims burden, but no comments were received.
Using our revised terminology, clinicians who used a QCDR or Registry will now collect measures via QCDR or MIPS CQM collection type; clinicians who used the EHR submission type will elect the eCQM collection type, and groups that elected the CMS Web Interface for MIPS will continue to elect the CMS Web Interface for MIPS.
Table 64 shows that in the 2019 MIPS performance period, an estimated 257,260 clinicians will submit data as individuals for the Medicare Part B claims collection type; 324,693 clinicians will submit data as individuals or as part of groups for the MIPS CQM or QCDR collection types; 243,062 clinicians will submit data as individuals or as part of groups via eCQM collection types; and 139,231 clinicians will submit as part of groups via the CMS Web Interface.
Table 64 provides estimates of the number of clinicians to collect quality measures data via each collection type, regardless of whether they decide to submit as individual clinicians or as part of groups. Because our burden estimates for quality data submission assume that burden is reduced when clinicians elect to submit as part of a group, we also separately estimate the expected number of clinicians to submit as individuals or part of groups.
In the CY 2018 Quality Payment Program final rule (82 FR 53625 through 53626), beginning with the 2019 MIPS performance period, we allowed MIPS eligible clinicians to submit data for multiple collection types for a single performance category. Therefore, we captured the burden of any eligible clinician that may have historically collected via multiple collection types, as we assume they will continue to collect via multiple collection types and that our MIPS scoring methodology will take the highest score where the same measure is submitted via multiple collection types. Hence, the estimated numbers of individual clinicians and groups to collect via the various collection types are not mutually exclusive and reflect the occurrence of individual clinicians or groups that collected data via multiple collection types during the MIPS 2017 performance period.
Table 65 uses methods similar to those described for Table 64 to estimate the number of clinicians that will submit data as individual clinicians via each collection type in the 2019 MIPS performance period. We estimate that approximately 257,260 clinicians will submit data as individuals using the Medicare Part B claims collection type; approximately 71,439 clinicians will submit data as individuals using MIPS CQMs or QCDR collection types; and approximately 47,557 clinicians will submit data as individuals using eCQMs collection type.
To be consistent with the policy in the CY 2018 Quality Payment Program final rule that for MIPS eligible clinicians who collect measures via Medicare Part B claims, MIPS CQM, eCQM, or QCDR collection types and submit more than the required number of measures (82 FR 53735 through 54736), we will score the clinician on the required measures with the highest assigned measure achievement points. Therefore, our columns in Table 65 are not mutually exclusive.
Table 66 provides our estimated counts of groups or virtual groups that will submit quality data on behalf of clinicians for each collection type in the 2019 MIPS performance period and reflects our assumption that the formation of virtual groups will reduce burden. We assume that groups that submitted quality data as groups in the 2017 MIPS performance period will continue to submit quality data either as groups or virtual groups for the same collection types as they did as a group or TIN within a virtual group for the 2019 MIPS performance period. First, we estimated the number of groups or virtual groups that will collect data via each collection type during the 2019 MIPS performance period using data from the 2017 MIPS performance period. The second and third steps in Table 66 reflect our currently approved assumption that virtual groups will reduce the burden for quality data submission by reducing the number of organizations that will submit quality data on behalf of clinicians. We assume that 40 groups that previously collected on behalf of clinicians via QCDR or MIPS CQM collection types will elect to form 8 virtual groups that will collect via QCDR and MIPS CQM collection types. We assume that another 40 groups that previously collected on behalf of clinicians via eCQM collection types will elect to form another 8 virtual groups that will collect via eCQM collection types. Hence, the second step in Table 66 is to subtract out the estimated number of groups under each collection type that will elect to form virtual groups, and the third step in Table 66 is to add in the estimated number of virtual groups that will submit on behalf of clinicians for each collection type.
Specifically, we assume that 10,542 groups and virtual groups will submit data for the QCDR or MIPS CQM collection types on behalf of 253,254 clinicians; 4,304 groups and virtual groups will submit for eCQM collection types on behalf of 195,505 eligible clinicians; and 286 groups will submit data via the CMS Web Interface on behalf of 139,231 clinicians. Because we are using 2017 MIPS performance period participation data to estimate participation for the 2019 MIPS performance period, our estimates do not account for the finalized policy to allow only groups that meet the definition of a small practice to submit quality data via the Medicare Part B claims collection type. Due to a lack of
The burden estimates associated with submission of quality performance category data 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 measures into the practice workflows is expected to vary along with the number of measures that are potentially applicable to a given clinician's practice and by the collection type. For example, clinicians submitting data via the Medicare Part B claims collection type need to integrate the capture of quality data codes for each encounter whereas clinicians submitting via the eCQM collection types may have quality measures automated as part of their EHR implementation.
We believe the burden associated with submitting quality measures data will vary depending on the collection type selected by the clinician, group, or third-party. As such, we separately estimated the burden for clinicians, groups, and third parties to submit quality measures data by the collection type used. For the purposes of our burden estimates for the Medicare Part B claims, MIPS CQM and QCDR, and eCQM collection types, we also assume that, on average, each clinician or group will submit 6 quality measures. In terms of the quality measures available for clinicians and groups to report for the 2019 MIPS performance period, the total number of quality measures will be 257. These measures are stratified by collection type in Table 67, as well as counts of new, removed, and substantively changed measures.
For the 2019 MIPS performance period, there is a net reduction of 18 quality measures across all collection types. We do not anticipate that removing these measures will increase or decrease the reporting burden on clinicians and groups.
In the CY 2018 Quality Payment Program final rule, the time associated with the Identity Management Application Process was described as “Obtain Account in CMS-Specified Identity Management System” and included in the ICR for Quality Data Submission by Clinicians and Groups: EHR Submission for a total burden of 54,218 hours (1 hr × 54,218 respondents) (82 FR 53914). After our review of the quality data submission process, we determined the burden associated with the application process (3,741 hours) should be accounted for in a separate ICR. Our per respondent burden estimate remains unchanged at 1 hour per response.
For an individual, group, or third-party to submit MIPS quality, improvement activities, or Promoting Interoperability performance category data using either the log in and upload or the log in and attest submission type or to access feedback reports, the submitter must have a CMS Enterprise Portal user account. Once the user account is created, registration is not required again for future years.
Based on the number of new TINs registered in the 2017 MIPS performance period, we estimate 3,741 eligible clinicians, groups, or third-parties will register for new accounts for the 2019 MIPS performance period. As shown in Table 68, it will take 1 hour at $89.18/hr for a computer systems analyst (or their equivalent) to obtain an account for the CMS Enterprise Portal. In aggregate, we estimate an annual burden of 3,741 hours (3,741 registrations × 1 hr/registration) at a cost of $333,622 (3,741 hr × $89.18/hr) or $89.18 per registration.
We received no public comments related to the burden estimates for the Identity Management Application Process. The burden estimates have not been updated from the CY 2019 PFS proposed rule (83 FR 36022 through 36023).
As noted in Table 64, based on 2017 MIPS performance period data, we assume that 257,260 individual clinicians will collect and submit quality data via the Medicare Part B claims collection type. We continue to anticipate that the Medicare Part B claims submission process for MIPS is 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 QDCs, and include the appropriate QDCs on the Medicare Part B 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. This final rule's provisions do not necessitate the revision of either form.
In this final rule, we have adjusted the number of respondents based on more recent data and adjusted our per respondent time estimates so that they correctly align with the number of required measures for which MIPS data must be submitted (6 measures) in comparison to the number of measures previously required under PQRS (9 measures).
The total estimated burden of Medicare Part B claims-based submission will vary along with the volume of Medicare Part B claims on which the submission is based. Based on our experience with PQRS, we estimate that the burden for submission of MIPS quality data will range from 0.15 to 7.2 hours per clinician, a reduction from the range of 0.22 to 10.8 hours as set out in the CY 2018 Quality Payment Program final rule (82 FR 53912). In the same rule, the 33 percent reduction in the number of measures (from 9 to 6) was erroneously omitted from our burden calculations; it is reflected in this final rule's burden estimates. The wide range of estimates for the time required for a clinician to submit quality measures via Medicare Part B claims reflects the wide variation in complexity of submission across different clinician quality measures. As shown in Table 69, we estimate that the cost of quality data submission using Medicare Part B claims will range from $13.38 (0.15 hr × $89.18/hr) to $642.10 (7.2 hr × $89.18/hr). The burden will involve becoming familiar with MIPS data submission requirements. We believe that the start-up cost for a clinician's practice to review measure specifications is 7 hours, consisting of 3 hours at $107.38/hr for a practice administrator, 1 hour at $206.44/hr for a clinician, 1 hour at $43.96/hr for an LPN/medical assistant, 1 hour at $89.18/hr for a computer systems analyst, and 1 hour at $36.98/hr for a billing clerk.
The estimate for reviewing and incorporating measure specifications for the claims collection type is higher than that of QCDRs/Registries or eCQM collection types due to the more manual, and therefore, more burdensome nature of claims measures.
Considering both data submission and start-up requirements, the estimated time (per clinician) ranges from a minimum of 7.15 hours (0.15 hr + 7 hr) to a maximum of 14.2 hours (7.2 hr + 7 hr). In this regard the total annual burden ranges from 1,819,082 hours (7.15 hr × 254,417 clinicians) to 3,612,721 hours (14.2 hr × 254,417 clinicians). The estimated annual cost (per clinician) ranges from $712.08 ($13.38 + $322.14 + $89.18 + $43.96 + $36.98 + $206.44) to a maximum of $1,340.80 ($642.10 + $322.14 + $89.18 + $43.96 + $36.98 + $206.44). The total annual burden ranges from a minimum
Table 69 summarizes the range of total annual burden associated with clinicians submitting quality data via Medicare Part B claims.
Independent of the change in the number of respondents, the change in estimated time per clinician results in a burden adjustment of between −19,463 hours at −$1,860,081 (278,039 clinicians × −0.07 hr × $89.18/hr) and −1,000,941 hours at −$89,261,641 (278,039 clinicians × −3.6 hr × $89.18/hr). Accounting for the change in the time burden per respondent, the decrease in number of respondents results in a total adjustment of between −148,713 hours at −$14,810,552 (−20,799 respondents × $712.08/respondent) and −295,346 hours at −$27,887,299 (−20,779 respondents × $1,340.80/respondent). When these two adjustments are combined, the net adjustment ranges between −168,176 (−19,463 −148,713) hours at −$16,670,633 (−$1,860,081 −$14,810,552) and −1,296,287 (−1,000,941 −295,346) hours at −$117,148,940 (−$89,261,641 −$27,887,299).
We received no public comments related to the burden estimates for quality performance category: Clinicians using the Medicare Part B claims collection type. However, the burden estimates have been updated from the CY 2019 PFS proposed rule to reflect availability of data from the 2017 MIPS performance period (83 FR 36023 through 36024).
As noted in Tables 64, 65, and 66, and based on 2017 MIPS performance period data, we assume that 324,693 clinicians will submit quality data as individuals or groups using MIPS CQM or QCDR collection types. Of these, we expect 71,439 clinicians, as shown in Table 65, will submit as individuals and 10,542 groups, as shown in Table 66, are expected to submit on behalf of the remaining 253,254 clinicians. Given that the number of measures required is the same for clinicians and groups, we expect the burden to be the same for each respondent collecting data via MIPS CQM or QCDR, whether the clinician is participating in MIPS as an individual or group.
Under the MIPS CQM and QCDR collection types, the individual clinician or group may either submit the quality measures data directly to us, log in and upload a file, or utilize a third-party intermediary to submit the data to us on the clinician's or group's behalf.
We estimate that the burden associated with the QCDR collection type is similar to the burden associated with the MIPS CQM collection type; therefore, we discuss the burden for both together below. For MIPS CQM and QCDR collection types, we estimate an additional time for respondents (individual clinicians and groups) to become familiar with MIPS submission requirements and, in some cases, specialty measure sets and QCDR measures. Therefore, we believe that the burden for an individual clinician or group to review measure specifications and submit quality data total 9.083 hours at $858.86. This consists of 3 hours at $89.18/hr for a computer systems analyst (or their equivalent) to submit quality data along with 2 hours at $107.38/hr for a practice administrator, 1 hour at $89.18/hr for a computer systems analyst, 1 hour at $43.96/hr for a LPN/medical assistant, 1 hour at $36.98/hr for a billing clerk, and 1 hour at $206.44/hr for a clinician to review measure specifications. Additionally, clinicians and groups will need to authorize or instruct the qualified registry or QCDR to submit quality measures' results and numerator and denominator data on quality measures to us on their behalf. We
In aggregate, we estimate an annual burden of 744,633 hours (9.083 hr/response × 81,981 groups plus clinicians submitting as individuals) at a cost of $71,016,861 (81,981 responses × $866.26/response). The decrease in number of respondents results in a total adjustment of −229,219 hours at −$21,860,937 (−25,236 respondents × $866.26/respondent). Based on these assumptions, we have estimated in Table 70 the burden for these submissions.
We received no public comments related to the burden estimates for quality performance category: Clinicians using the MIPS CQM/QCDR collection type. However, the burden estimates have been updated from the CY 2019 PFS proposed rule to reflect availability of data from the 2017 MIPS performance period (83 FR 36024 through 36025).
As noted in Tables 64, 65, and 66, based on 2017 MIPS performance period data, we assume that 243,062 clinicians will elect to use the eCQM collection type; 47,557 clinicians are expected to submit eCQMs as individuals; and 4,304 groups are expected to submit eCQMs on behalf of the remaining 195,505 clinicians. We expect the burden to be the same for each respondent using the eCQM collection type, whether the clinician is participating in MIPS as an individual or group.
In the CY 2018 Quality Payment Program final rule, the time required for users to obtain an account for the CMS Enterprise Portal was included in this Quality Data Submission by Clinicians and Groups: eCQM Collection Type ICR (82 FR 53914). However, in this final rule, we are finalizing a separate ICR for this activity (now described as the Quality Payment Program Identity Management Application Process; see Table 68) and therefore, reduce (by 1 hour) our per respondent burden estimate for this ICR commensurately. We have also adjusted the number of respondents based on more recent data.
Under the eCQM collection type, the individual clinician or group may either submit the quality measures data directly to us from their eCQM, log in and upload a file, or utilize a health IT vendor to submit the data to us on the clinician's or group's behalf.
To prepare for the eCQM collection type, the clinician or group must review the quality measures on which we will be accepting MIPS data extracted from eCQMs, select the appropriate quality measures, extract the necessary clinical data from their CEHRT, 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 collecting quality measures data via eCQM is similar for clinicians and groups who submit their data directly to us from their CEHRT and clinicians and groups who use a health IT vendor to submit the data on their behalf. This includes extracting the necessary clinical data from their CEHRT and submitting the necessary data to the CMS-designated clinical data warehouse.
We continue to estimate that it will take no more than 2 hours at $89.18/hr for a computer systems analyst to submit the actual data file. The burden
In aggregate we estimate an annual burden of 414,888 hours (8 hr × 51,861 groups and clinicians submitting as individuals) at a cost of $39,916,374 (51,861 responses × $769.68/response) (see Table 71).
Independent of the change in the number of respondents, removing the time burden associated with completing the Quality Payment Program Identity Management Application Process results in an adjustment to the total burden of −54,218 hours and −$4,835,161 (54,218 respondents × −1 hr × $89.18/hr). Accounting for the change in the per respondent time estimate, the decrease in number of respondents results in a total adjustment of −18,856 hours at −$1,814,136 (−2,357 respondents × $769.68/respondent). When these two adjustments are combined, the net adjustment is −73,074 (−54,218-18,856) hours at −$6,649,297 (−$4,835,161-$1,814,136).
We received no public comments related to the burden estimates for quality performance category: Clinicians using the eCQM collection type. However, the burden estimates have been updated from the CY 2019 PFS proposed rule to reflect availability of data from the 2017 MIPS performance period (83 FR 36025 through 36026).
As discussed in section III.I.3.h.(2)(a)(iii)(A)(bb) of this rule, we are finalizing a 33 percent reduction in the number of measures (from 15 to 10 measures) for which clinicians are required to submit quality data via the CMS Web Interface. To account for the decrease in measures, we are also finalizing a decrease to our per respondent time estimate.
We assume that 286 groups will submit quality data via the CMS Web Interface based on the number of groups who registered for using the CMS Web Interface during the 2018 MIPS performance period. This is a decrease of 10 groups from the currently approved number provided in the CY 2018 Quality Payment Program final rule (82 FR 53915) due to receipt of more current data. We estimate that approximately 91,757 clinicians will submit via this method.
The burden associated with the group submission requirements 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. In the CY 2018 Quality Payment Program final rule, we estimated that it would take, on average, 74 hours for each group to submit quality measures data via the CMS Web Interface (82 FR 53915). Of those hours, approximately half (or 37 hr) are unaffected by the number of required measures while the other half (37 hr) are affected proportionately by the number of required measures (37 hr × 33 percent reduction = 24.67 hr). Accounting for the finalized reduction in required measures, our revised estimate for the time to submit data via the CMS Web Interface for the 2019 MIPS performance period is 61.67 hours (37 hr + 24.67 hr), a reduction of 12.33 hours or approximately 18 percent of the currently approved 74 hour time estimate. Considering only the time which varies based on the number of required measures, the process of entering or uploading data requires approximately 2.74 hours of a computer systems analyst's time per measure (24.67 hr/9 measures). Our estimate 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 submit the data (we will partially pre-populate the CMS Web Interface with claims data
Independent of the change in the number of respondents, the decrease in total burden resulting from the decrease in required measures is −3,650 hours at −$325,566 (296 groups × −12.33 hr × $89.18/hr). Accounting for the decrease in total time, the decrease in number of respondents results in a total adjustment of −616.7 hours at −$54,994 (−10 respondents × 61.67 hr × $89.18/hr). When these adjustments are combined, the net adjustment is −4,267 (−3,650-617) hours at −$380,560 (−$325,566-$54,994).
Based on the assumptions discussed in this section, Table 72 summarizes the burden for groups submitting to MIPS via the CMS Web Interface.
We received no public comments related to the burden estimates for quality data submission via the CMS Web Interface. However, the burden estimates have been updated from the CY 2019 PFS proposed rule to reflect the change in the number of required measures from 9 in the proposed rule to 10 in the final rule (83 FR 36026 through 36027).
In this final rule, we have adjusted the number of groups electing to report on the CAHPS for MIPS survey as well as the average number of beneficiaries per group based on more recent data.
Under MIPS, groups of 25 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 explained in section V.A. of this final rule, BLS data sets out an average hourly wage for civilians in all occupations at $24.34/hr. 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 our cost estimate for the beneficiaries' time.
For the 2019 MIPS performance period, we assume that 143 groups will elect to report on the CAHPS for MIPS survey, which is equal to the number of groups that have registered and have a sufficient beneficiary sample size to conduct the CAHPS for MIPS survey in the 2018 MIPS performance period; a decrease of 318 from the 461 groups currently approved by OMB. Table 73 shows the estimated annual burden for beneficiaries to participate in the CAHPS for MIPS Survey. Based on the number of complete and partially complete surveys for groups participating in CAHPS for MIPS survey administration for the 2018 MIPS performance period, we assume that an average of 273 beneficiaries will respond per group for the 2019 MIPS performance period. Therefore, the CAHPS for MIPS survey will be administered to approximately 39,039 beneficiaries per year (143 groups × an average of 273 beneficiaries per group responding). This is a decrease of 93,268 from our currently approved 132,307 beneficiary estimate.
The CAHPS for MIPS survey that will be administered in the 2019 MIPS performance period is unchanged from the survey administered in the 2018 MIPS performance period. In that regard, we continue to estimate an average administration time of 12.9 minutes (or 0.215 hr) at a pace of 4.5 items per minute for the English version of the survey. For the Spanish version, we estimate an average administration time of 15.5 minutes (assuming 20 percent more words in the Spanish translation). However, since less than 1 percent of surveys were administered in Spanish for reporting year 2016, our burden estimate reflects the time for administering the English version of the survey.
Given that we expect approximately 39,039 respondents, we estimate an annual burden of 8,393 hours (39,039 respondents × 0.215 hr/respondent) at a cost of $204,286 (8,393 hr × $24.34/hr).
The decrease in the number of beneficiaries responding to the CAHPS for MIPS survey results in an adjustment to the total time burden of −20,715 hours and −$503,556 (−93,268 beneficiaries × 0.215 hr × $24.34/hr).
We received no public comments related to the burden estimates for beneficiary participation in CAHPS for MIPS survey. However, the burden estimates have been updated from the CY 2019 PFS proposed rule to reflect availability of data from the 2018 MIPS performance period (83 FR 36027).
In this final rule, we have adjusted the number of respondents based on more recent data and adjusted our per response time estimate based on our review of the currently approved estimates against the existing registration process.
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 74, we estimate that the registration process for groups under MIPS involves approximately 0.25 hours at $89.18/hr for a computer systems analyst (or their equivalent) to register the group. Although the registration process remains unchanged from the CY 2018 Quality Payment Program final rule, a review of the steps required for registration warranted a reduction of 0.75 hours in estimated burden per group (82 FR 53917).
We assume that approximately 67 groups will elect to use the CMS Web Interface for the first time during the 2019 MIPS performance period based on the number of new registrations received during the CY 2018 registration period; an increase of 57 compared to the number of groups currently approved by OMB under control number 0938-1314 (CMS-10621). In aggregate, we estimate a burden of 16.75 hours (67 new registrations × 0.25 hr/registration) at a cost of $1,494 (16.75 hr × $89.18/hr).
Independent of the decrease in time burden per group, the increase in the number of groups registering to submit MIPS data via the CMS Web Interface results in an adjustment to the total time burden of 57 hours at $5,083 (57 groups × 1 hr × $89.18/hr). Accounting for the increase in the number of groups, the decrease in time burden per group to register results in an adjustment to the total burden of −50.25 hours at −$4,481 (67 groups × −0.75 hrs × $89.18/hr). When these adjustments are combined, the net adjustment is 6.75 hours (57−50.25) at $602 ($5,083−$4,481).
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 2019 PFS proposed rule (83 FR 36027 through 36028).
In this final rule, we have adjusted our currently approved number of respondents based on more recent data and adjusted our per respondent time estimate based on our review of the current burden estimates against the existing registration process.
Under MIPS, the CAHPS for MIPS survey counts for 1 measure toward the MIPS quality performance category and, as a patient experience measure, it 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
As shown in Table 75, 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 $89.18/hr. We assume the CAHPS for MIPS Survey registration burden consists of 0.25 hours to register for the survey as well as 0.5 hours to select the CAHPS for MIPS Survey vendor that will be used and electronically notifying CMS of this selection. In this regard, the total time for CAHPS for MIPS registration is 0.75 hours. Although the registration process remains unchanged from the CY 2018 Quality Payment Program final rule, after we reviewed the steps required for registration more thoroughly, we believe that the burden was less than we had originally estimated. Therefore, we have adjusted the estimated burden from 1.5 hours to 0.75 hours per respondent.
In aggregate, we estimate an annual burden of 211.50 hours (282 groups × 0.75 hr per group) at a cost of $18,862 (211.50 hr × $89.18/hr).
Independent of the change in time per group, the decrease in the number of groups registering results is an adjustment to the total burden of −268.5 hours at −$23,945 (−179 groups × 1.5 hrs × $89.18/hr). Accounting for the decrease in the number of groups registering, the decrease in time per group to register results in an adjustment to the total burden of −211.5 hours at −$18,862 (282 groups × −0.75 hr × $89.18/hr). When these adjustments are combined, the net adjustment is −480 hours (−268.5−211.5) at −$42,807 (−$23,945−$18,862).
We received no public comments related to the burden estimates for group registration for the CAHPS for MIPS survey. However, the burden estimates have been updated from the CY 2019 PFS proposed rule to reflect availability of data from the 2018 MIPS performance period (83 FR 36028 through 36029).
This rule does not include any new or revised reporting, recordkeeping, or third-party disclosure requirements related to the nomination of quality measures. However, we have adjusted our currently approved burden estimates based on more recent data. We have also accounted for burden associated with policies that have been finalized but whose burden were erroneously excluded from our estimates. The new and adjusted burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).
As discussed in section III.I.3.h.(2)(b)(i) of this final rule, quality measures are selected annually through a call for quality measures under consideration, with a final list of quality measures being published in the
As we described 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
To identify and submit a quality measure, eligible clinician organizations and other relevant stakeholders use a one-page online form that requests information on background, a gap analysis which includes evidence for the measure, reliability, validity, endorsement and a summary which includes how the proposed measure relates to the Quality Payment Program and the rationale for the measure. In addition, proposed measures must be accompanied by a completed Peer Review Journal Article form.
As shown in Table 76, we estimate that approximately 140 organizations, including clinicians, CEHRT developers, and vendors, will submit measures for the Call for Quality Measures process; an increase of 100 compared to the number of organizations currently approved by OMB. In keeping with the focus on clinicians as the primary source for recommending new quality measures, we are using practice administrators and clinician time for our burden estimates. We also estimate it will take 0.5 hours per organization to submit an activity to us, consisting of 0.3 hours at $107.38/hr for a practice administrator to make a strategic decision to nominate and submit a measure and 0.2 hours at $206.44/hr for clinician review time.
The 0.5 hour estimate assumes that submitters will have the necessary information to complete the nomination form readily available, which we believe is a reasonable assumption. Additionally, some submitters familiar
Consistent with the CY 2017 Quality Payment Program final rule, we also estimate it will take 4 hours at $206.44/hr for a clinician (or equivalent) to complete the Peer Review Journal Article Form (81 FR 77153 through 77155). This assumes that measure information is available and testing is complete in order to have the necessary information to complete the form, which we believe is a reasonable assumption. Although the requirement for completing the Peer Review Journal Article was previously included in the CY 2017 Quality Payment Program final rule, the time required for completing the form was erroneously excluded from our burden estimates.
As shown in Table 76, in aggregate we estimate an annual burden of 630 hours (140 organizations × 4.5 hr/response) at a cost of $125,896 (140 × [(0.3 hr × $107.38/hr) + (4.2 hr × $206.44/hr)].
Independent of the change in time per organization, the change in the number of organizations nominating new quality measures results in an adjustment of 50 hours at $7,350 (100 organizations × [(0.3 hr × $107.38/hr) + (0.2 hr x $206.44/hr)]). When accounting for the change in respondents, the change in burden to nominate a quality measure results in an adjustment of 560 hours at $115,606 (140 organizations × 4 hr × $206.44/hr). When these adjustments are combined, the total adjustment is 610 hours (560 + 50) at $122,956 ($7,350 + $115,606).
We received no public comments related to the burden estimates for the Call for Quality Measures. The burden estimates have not been updated from the CY 2019 PFS proposed rule (83 FR 36029 through 36030).
The finalized requirements and burden discussed under this section will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).
For the 2019 MIPS performance period, clinicians and groups can submit Promoting Interoperability data through direct, log in and upload, or log in and attest submission types. We have worked to further align the Promoting Interoperability performance category with other MIPS performance categories. With the exception of submitters who elect to use the log in and attest submission type for the Promoting Interoperability performance category which is not available for the quality performance category, we anticipate that most organizations will use the same data submission type for the both of these performance categories and that the clinicians, practice managers, and computer systems analysts involved in supporting the quality data submission will also support the Promoting Interoperability data submission process. Hence, the following burden estimates show only incremental hours required above and beyond the time already accounted for in the quality data submission process. Although this analysis assesses burden by performance category and submission type, we emphasize that MIPS is a consolidated program and submission analysis and decisions are expected to be made for the program as a whole.
Table 77 summarizes the burden for clinicians to apply for reweighting the
The total of 6,041 respondents represents a decrease of 34,604 from the number of respondents currently approved by OMB. The application to request a reweighting to zero percent only for the Promoting Interoperability performance category is a short online form that requires identifying the type of hardship experienced or whether decertification of an EHR has occurred and a description of how the circumstances impair the clinician or group's ability to submit Promoting Interoperability data, as well as some proof of circumstances beyond the clinician's control. The application for reweighting of the quality, cost, Promoting Interoperability, and/or improvement activities performance categories due to extreme and uncontrollable circumstances requires the same information with the exception of there being only one option for the type of hardship experienced. We estimate it will take 0.25 hours at $89.18/hr for a computer system analyst to submit the application. This is a reduction from the 0.5 hours estimated in the CY 2018 Quality Payment Program final rule due to a revised assessment of the application process (82 FR 53918). As shown in Table 77, in aggregate, we estimate an annual burden of 1,510.25 hours (6,041 applications × 0.25 hr/application) at a cost of $134,684 (1,510.25 hr × $89.18/hr).
Independent of the change to the number of respondents, the decrease in the amount of time to submit a reweighting application results in an adjustment of −10,161.25 hours at −$906,180 (40,645 respondents × −0.25 hr × $89.18/hr). Accounting for the decrease in time per respondent, the decrease in the number of respondents submitting reweighting applications results in an adjustment of −8,651 hours at −$771,496 (−34,604 respondents × 0.25 hr × $89.18hr). When these adjustments are combined, the total adjustment is −18,812.25 hours (−10,161.25−8,651) at $1,677,676 (−$906,180−$771,496).
The following is a summary of the public comments received on the Quality Payment Program ICRs regarding reweighting applications for Promoting Interoperability and other performance categories:
After consideration of public comments, we are making no changes to our estimates as a result of public comments received. However, the burden estimates have been updated from the CY 2019 PFS proposed rule to reflect availability of data from the 2017 MIPS performance period (83 FR 36030 through 36031).
A variety of organizations will submit Promoting Interoperability data on behalf of clinicians. Clinicians not participating in a MIPS APM may submit data as individuals or as part of a group. In the CY 2017 Quality Payment Program final rule (81 FR 77258 through 77260, 77262 through 77264), we established that eligible clinicians in MIPS APMS other than the Shared Savings Program may submit data for the Promoting Interoperability performance category as individuals or as part of a group, whereas eligible clinicians participating in the Shared Savings Program are limited to submitting data through the ACO participant TIN. In section III.I.3.h.(6)(d)(ii) of this final rule, we are finalizing our proposal to extend this flexibility to allow for both individual and group reporting by eligible clinicians participating in the Shared Savings Program.
As shown in Table 78, based on data from the 2017 MIPS performance period, we estimate that a total of 93,933 respondents consisting of 81,456 individual MIPS eligible clinicians and 12,413 groups will submit Promoting Interoperability data. Similar to the process shown in Table 66 for groups reporting via QCDR/MIPS CQM and eCQM collection types, we have adjusted the group reporting data from the 2017 MIPS performance period to account for virtual groups, as the option to submit data as a virtual group was not available until the 2018 MIPS performance period. These estimates reflect that under the policies in the CY 2017 Quality Payment Program final rule and in the CY 2018 Quality Payment Program final rule, certain MIPS eligible clinicians will be eligible for automatic reweighting of the Promoting Interoperability performance category to zero percent, including MIPS eligible clinicians that are hospital-based, ambulatory surgical center-based, non-patient facing clinicians, physician assistants, nurse practitioners, clinician nurse specialists, and certified registered nurse anesthetists (81 FR 77238 through 77245 and 82 FR 53680 through 53687). As discussed in section III.I.3.h.(5)(h)(ii) of this final rule, starting with the 2021 MIPS payment year, we are finalizing a policy to automatically reweight the Promoting Interoperability performance category for clinician types new to MIPS: Physical therapists; occupational therapists; qualified speech-language pathologists or qualified audiologist; clinical psychologists; and registered dieticians or nutrition professionals. These estimates also account for the reweighting policies finalized in the CY 2017 and CY 2018 Quality Payment Program final rules, including exceptions for MIPS eligible clinicians who have experienced a significant hardship (including clinicians who are in small practices), as well as exceptions due to decertification of an EHR.
Further, we assume that Shared Savings Program Track 1 ACOs will submit data at the ACO participant TIN-level, APM Entities electing the one-sided track in the CEC model will submit data at the group TIN-level, and APM Entities in the OCM (one-sided risk arrangement) will submit data at APM Entity level; these entities are included in our estimate of the number of groups submitting data. Our respondent estimate is based on existing data and does not consider policies finalized in section V of this final rule, as well as additional policies that were proposed in the August 2018 proposed rule and may be finalized in a future rule, which may change the number of Shared Saving Program ACOs that are required to submit Promoting Interoperability data for future years.
In the CY 2018 Quality Payment Program final rule, we estimated it takes 3 hours for a computer system analyst to collect and submit Promoting Interoperability performance category data (82 FR 53920). For this final rule, we estimate the time required to submit such data should be reduced by 20 minutes to 2.67 hours due to the reduction in the number of measures for which clinicians are required to submit data, which we are finalizing as discussed in section III.I.3.h.(5)(f) of this final rule. As shown in Table 78, the total time for an organization to submit data on the specified Promoting Interoperability objectives and measures is estimated to be 250,317 hours (93,869 respondents × 2.67 incremental hours for a computer analyst's time above and beyond the clinician, practice manager, and computer system's analyst time required to submit quality data) at a cost of $22,323,300 (250,317 hr × $89.18/hr).
Independent of the change in the number of respondents, the reduction in estimated time to submit Promoting Interoperability data results in a decrease in burden of −72,738.33 hours at −$6,486,805 (218,215 respondents × −0.33 hr × $89.18/hr). Accounting for the decreased per respondent time, the decrease in the number of respondents
The following is a summary of the public comments received on the Quality Payment Program ICRs regarding Promoting Interoperability Data:
After consideration of public comments, we are making no changes to our estimates as a result of public comments received. However, the burden estimates have been updated from the CY 2019 PFS proposed rule to reflect availability of data from the 2017 MIPS performance period (83 FR 36031 through 36032).
This rule does not include any new or revised reporting, recordkeeping, or third-party disclosure requirements related to the nomination of Promoting Interoperability measures. However, we have adjusted our currently approved burden estimates based data from the 2017 MIPS performance period. The adjusted burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).
Consistent with our requests for stakeholder input on quality measures and improvement activities, we also request potential measures for the Promoting Interoperability performance category that measure patient outcomes, emphasize patient safety, support improvement activities and the quality performance category, and build on the advanced use of CEHRT using 2015 Edition standards and certification criteria. Promoting Interoperability measures may be submitted via a designated submission form that includes the measure description, measure type (if applicable), reporting requirement, and CEHRT functionality used (if applicable).
We estimate 47 organizations will submit Promoting Interoperability measures, based on the number of organizations submitting measures during the CY 2017 nomination period. This is an increase of 7 from the estimate currently approved by OMB under the aforementioned control number. We estimate it will take 0.5 hours per organization to submit an activity to us, consisting of 0.3 hours at $107.38/hr for a practice administrator to make a strategic decision to nominate that activity and submit an activity to us via email and 0.2 hours at $206.44/hr for a clinician to review the nomination. As shown in Table 80, in aggregate, we estimate an annual burden of 235 hours (47 organizations × 0.5 hr/response) at a cost of $3,455 (47 × [(0.3 h × $107.38/hr) + (0.2 hr × $206.44/hr)]. The increase in the number of respondents results in an adjustment of 3.5 hours and $514.50 (7 respondents × 0.5 hrs × $73.50 per respondent).
We received no public comments related to the burden estimates for the Call for Promoting Interoperability Measures. The burden estimates have not been updated from the CY 2019 PFS proposed rule (83 FR 36032 through 36033).
This rule does not include any new or revised reporting, recordkeeping, or third-party disclosure requirements related to the submission of Improvement Activities data. However, we have adjusted our currently approved burden estimates based on more recent data. The adjusted burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).
We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77511 through 77512) and the CY 2018 Quality Payment Program final rule (82 FR 53920 through 53922) for our previous burden estimates for improvement activities under the Quality Payment Program.
The CY 2018 Quality Payment Program final rule provides: (1) 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 (82 FR 53651); (2) that the term “recognized” is 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 (82 FR 53649); and (3) 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 (82 FR 53655).
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 (81 FR 77817 through 77831). 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, although, as we noted, we anticipate that MIPS APMs in the 2019 MIPS performance period will not need to submit additional improvement activities as the models will already meet the maximum improvement activities performance category score (81 FR 77185).
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 through direct, log in and upload submission types, and CMS Web Interface will also submit improvement activities data. As finalized in the CY 2017 Quality Payment Program final rule (81 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 assumed that all APM Entities will receive the maximum CMS-assigned improvement activities score (82 FR 53921 through 53922).
As represented in Table 81, based on 2017 MIPS performance period data, we estimate that 125,713 clinicians will submit improvement activities as individuals during the 2019 MIPS performance period and 16,478 groups will submit improvement activities on behalf of clinicians. Similar to the process shown in Table 77 for groups submitting Promoting Interoperability data, we have adjusted the group reporting data from the 2017 MIPS performance period to account for virtual groups, as the option to submit data as a virtual group was not available until the 2018 MIPS performance period.
Our 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 also assume that the MIPS APM models for the 2019 MIPS performance period will qualify for the maximum improvement activities performance category score and the APM Entities will not need to submit any additional improvement activities.
As described in section III.I.3.h.(4)(b) of this final rule, for purposes of the 2021 MIPS payment year, we have finalized § 414.1360(a)(1) to more accurately reflect the data submission process for the improvement activities performance category. In particular, instead of “via qualified registries; EHR submission mechanisms; QCDR, CMS Web Interface; or attestation,” as currently stated, we have revised the first sentence to state that data will be submitted “via direct, log in and upload, and log in and attest.” The revision will more closely align with the actual submission experience users have.
In the CY 2018 Quality Payment Program final rule, we estimated it would take 1 hour for a computer system analyst to submit data on the specified improvement activities (82 FR 53922). We are finalizing to decrease this burden estimate since the actual submission experience of the user is such that improvement activities data is submitted as part of the process for submitting quality and Promoting Interoperability data, resulting in less additional required time to submit improvement activities data. As a result, we estimate that the per response time required per individual or group is 5 minutes at $89.18/hr for a computer system analyst to submit by logging in and manually attesting that certain activities were performed in the form and manner specified by CMS with a set of authenticated credentials. Additionally, as stated in the CY 2018 Quality Payment Program final rule, the same improvement activity may be reported across multiple performance periods so many MIPS eligible clinicians will not have any additional information to submit for the 2019 MIPS performance period (82 FR 53921).
As discussed in section III.I.3.h.(4)(d)(ii) of this final rule, we are also finalizing for CY 2019 and future years to: Add 6 new improvement activities; modify 5 existing improvement activities; and remove 1 existing improvement activity. Because MIPS eligible clinicians are still required to submit the same number of activities, we do not expect these provisions to affect our collection of information burden estimates. In addition, in order for an eligible clinician or group to receive credit for being a patient-centered medical home or comparable specialty practice, the eligible clinician or group must attest in the same manner as any other improvement activity.
As shown in Table 82, we estimate an annual burden of 11,333.7 hours (136,004 responses × 5 minutes/60) at a cost of $1,010,736 (11,333.7 hr × $89.18/hr).
Independent of the change to our per response time estimate, the decrease in the number of respondents results in an adjustment of −303,782 hours at −$27,091,279 (−303,782 respondents × 1 hr × $89.18/hr). Accounting for the change in number of respondents, the decrease in the time to submit improvement activities data results in an adjustment of −124,670.33 hours at −$11,118,100.33 (136,004 respondents × 55 minutes/60 × $89.18/hr). When these adjustments are combined, the total adjustment is −428,452.33 hours (−303,782−124,670.33) hours at −$38,209,379.33 (−$27,091,279−$11,118,100.33).
The following is a summary of the public comments received on the Quality Payment Program ICRs regarding Improvement Activities Submission:
After consideration of public comments, we are making no changes to our estimates as a result of public comments received. However, the burden estimates have been updated from the CY 2019 PFS proposed rule to reflect availability of data from the 2017 MIPS performance period (83 FR 36033 through 36034).
The finalized requirements and burden discussed under this section will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). We refer readers to the CY 2018 Quality Payment Program final rule for our previous burden estimates for nomination of improvement activities under the Quality Payment Program (82 FR 53922). In this final rule, we have adjusted the number of respondents based on more recent data and adjusted our per response time estimate based on our review of our currently approved burden estimates against the existing process for nomination of improvement activities. As discussed in section III.I.3.h.(4)(d)(i)(A) of this final rule, we are also finalizing to adopt one new criteria and remove one existing criteria for nominating new improvement activities beginning with the CY 2019 performance period and future years. Furthermore, we have made clarifications to: (1) Considerations for selecting improvement activities for the CY 2019 performance period and future years; and (2) the weighting of improvement activities. We believe these policy changes will not affect our currently approved burden estimates since they do not substantively impact the level of effort previously estimated to nominate an Improvement Activity.
As discussed in section III.I.3.h.(4)(d)(i)(D) of this final rule, we are finalizing changing the performance year for which the nominations will apply, such that improvement activities nominations received in a particular year will be vetted and considered for the next year's rulemaking cycle for possible implementation in the following year. Also, as discussed in section III.I.3.h.(4)(d)(i)(D) of this final rule, we are finalizing changing the submission timeframe for the Call for Activities from February 1st through March 1st to February 1st through June 30th, providing approximately four additional months for stakeholders to submit nominations. We believe these policy changes will not affect our currently approved burden estimates since we believe that the number of nominations is unlikely to change, but the quality of the nominations is likely to increase given the additional time provided.
For the 2018 MIPS performance period, we provided opportunity for stakeholders to propose new activities formally via the Annual Call for Activities nomination form that was posted on the CMS website (82 FR 53657). The 2018 Annual Call for Activities lasted from March 2, 2017 through March 1, 2018, for which we received 72 nominations consisting of a total of 125 activities which were evaluated for the Improvement Activities Under Consideration (IAUC) list for possible inclusion in the CY 2019 Improvement Activities Inventory. Based on the number of activities being evaluated during the 2018 Annual Call for Activities (125 activities), we estimate that the total number of nominations we will receive for the 2019 Annual Call for Activities will continue to be 125, unchanged from the number of activities evaluated in CY 2018, which is a decrease from the 150 nominations currently approved by OMB.
In the CY 2018 Quality Payment Program final rule, we estimated that it takes 0.5 hours to nominate an improvement activity (82 FR 53922). As shown in Table 83, due to a review of the nomination process including the criteria required to nominate an improvement activity, we now estimate it will take 2 hours (per organization) to submit an activity to us. Of those hours, we estimate it will take 1.2 hours at $107.38/hr for a practice administrator or equivalent to make a strategic decision to nominate and submit that activity and 0.8 hours at $206.44/hr for a clinician's review. In aggregate, we estimate an annual burden of 250 hours (125 nominations × 2 hr/nomination) at a cost of $36,751 (125 × [(1.2 hr × $107.38/hr) + (0.8 hr × $206.44/hr)]).
The percentage of practice administrator and clinician labor in relation to the total is unchanged from the CY 2018 Quality Payment Program final rule (82 FR 53922).
Independent of the change to our per response time estimate, the decrease in the number of nominations results in an adjustment of −12.5 hours and −$1,837 (−25 activities × [(0.3 hr × $107.38/hr) + (0.2 hr × $206.44/hr)]). Accounting for the decrease in the number of nominated improvement activities, the increase in time per nominated improvement activity results in an adjustment of 187.5 hours and $27,563 (125 activities × [(0.9 hr × $107.38/hr) + (0.6 hr × $206.44/hr)]). When these adjustments are combined, the total adjustment is 175 hours (187.5−12.5) and $25,726 ($27,563−$1,837).
The following is a summary of the public comments received on the Quality Payment Program ICRs regarding Improvement Activities Submission:
After consideration of public comments, we are making no changes to our estimates as a result of public comments received. The burden estimates have not been updated from the CY 2019 PFS proposed rule (83 FR 36034 through 36035).
During each performance year, eligible clinicians are recruited to participate in the CMS study on the burden associated with reporting quality measures. Eligible clinicians who are interested in participating can sign up whereby an adequate sample size is then selected by CMS from this group of potential participants. This study is ongoing, and participants are recruited on a yearly basis. Current participants can sign up when the study year ends.
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. Consequently, we are not setting out such burden since the study shall inform us (and our contractors) on the root causes of clinicians' performance measure data collection and data submission burdens and challenges that hinders accurate and timely quality measurement activities. We refer readers to the discussion of this policy in section VII.F.7 of this final rule.
The cost performance category relies on administrative claims data. The Medicare Parts A and B claims submission process (OMB control number 0938-1197) is used to collect data on cost measures from MIPS eligible clinicians. MIPS eligible clinicians are not required to provide any documentation by CD or hardcopy. Moreover, the provisions of this final rule do not result in the need to add or revise or delete any claims data fields. Therefore, we do not anticipate any new or additional submission requirements and/or burden for MIPS eligible clinicians resulting from the cost performance category.
We received no public comments related to burden for the cost performance category.
This rule does not include any new or revised reporting, recordkeeping, or third-party disclosure requirements related to QP elections. However, we have adjusted our currently approved burden estimates based on more recent data. The adjusted burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).
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 as soon as possible after each QP determination. Where Partial QP status is earned at the APM Entity level, the burden of Partial QP election will be incurred by a representative of the participating APM Entity. Where Partial QP status is earned at the eligible clinician level, the burden of Partial QP election will be incurred by the eligible clinician. For the purposes of this burden estimate, we assume that all MIPS eligible clinicians determined to be Partial QPs will participate in MIPS.
Based on our predictive QP analysis for the 2019 QP performance period, we estimate that 6 APM Entities and 75 eligible clinicians will make the election to participate as a Partial QP in MIPS (see Table 84), an increase of 64 from the 17 elections currently approved by OMB under the aforementioned control number. We estimate it will take the APM Entity representative or eligible clinician 15 minutes (0.25 hr) to make this election. In aggregate, we estimate
We received no public comments related to the burden estimates for Partial QP Election. The burden estimates have not been updated from the CY 2019 PFS proposed rule (83 FR 36036).
As indicated below, the finalized requirements and burden discussed under this section will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).
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 advance notice prior to the start of a given performance period, and to allow other payers to be involved prospectively in the process, the 2018 CY Quality Payment Program final rule established a payer-initiated process for identifying payment arrangements that qualify as Other Payer Advanced APMs (82 FR 53844). The payer-initiated process for Other Payer Advanced APM determinations began in CY 2018 for Medicaid, Medicare Health Plans, and payers participating in CMS multi-payer models. Payers seeking to submit payment arrangement information for Other Payer Advanced APM determination through the payer-initiated process are required to complete a Payer Initiated Submission Form, instructions for which is available at
Also in the CY 2018 Quality Payment Program final rule we established our intent to finalize that the remaining other payers, including commercial and other private payers, may request that we determine whether other payer arrangements are Other Payer Advanced APMs starting prior to the 2020 QP performance period and each performance period thereafter (82 FR 53867). As a result, in this final rule, we finalized our proposal to eliminate the Payer Initiated Process that is specifically for CMS Multi-Payer Models. We believe that payers aligned with CMS Multi-Payer Models can submit their arrangements through the Payer Initiated Process for Remaining Other Payers in section III.I.4.e.(4)(c) of this final rule, or through the Medicaid or Medicare Health Plan payment arrangement submission processes.
As shown in Table 85, we estimate that in 2019 for the 2020 QP performance period 215 payer-initiated requests for Other Payer Advanced APM determinations will be submitted (15 Medicaid payers, 100 Medicare Advantage Organizations, and 100 remaining other payers), a decrease of 85 from the 300 total requests currently approved by OMB under the aforementioned control number. We estimate it will take 10 hours at $89.18/hr for a computer system analyst per arrangement submission. In aggregate, we estimate an annual burden of 2,150 hours (215 submissions × 10 hr/submission) at a cost of $191,737 (2,150 hr × $89.18/hr). The decrease in the number of payer-initiated requests results in an adjustment of −850 hours and −$75,803 (−85 requests × 10 hr × $89.18/hr).
We received no public comments related to the burden estimates for Other Payer Advanced APM Identification Determinations: Payer-Initiated Process. The burden estimates have been updated from the CY 2019 PFS proposed rule to reflect updated respondent estimates (83 FR 36036 through 36037).
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 a given performance period, and to allow other payers to be involved prospectively in the process, the CY 2018 Quality Payment Program final rule provided a payer-initiated identification process for identifying payment arrangements that qualify as Other Payer Advanced APMs (82 FR 53854). In the same rule, under the Eligible Clinician Initiated Process, APM Entities and eligible clinicians participating in other payer arrangements will have an opportunity to request that we determine for the year whether those other payer arrangements are Other Payer Advanced APMs (82 FR 53857—53858). However, to appropriately implement the statutory requirement to exclude from the All Payer Combination Option QP threshold calculations certain Title XIX payments and patients, we determined it will be problematic to allow APM Entities and eligible clinicians to request determinations for Title XIX payment arrangements after the conclusion of the QP performance period because any late-identified 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). Thus, the CY 2018 Quality Payment Program final rule provided 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 a given QP performance period (82 FR 53858). This will 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 will 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 for Other Payer Advanced APMs also began in CY 2018, and determinations made in 2018 are applicable for the Quality Payment Program Year 3. Eligible clinicians or APM Entities seeking to submit payment arrangement information for Other Payer Advanced APM determination through the Eligible Clinician-Initiated process are required to complete an Eligible Clinician Initiated Submission Form, instructions for which is available at
As shown in Table 86, we estimate that 150 other payer arrangements will be submitted by APM Entities and eligible Other Payer Advanced APM determinations, an increase of 75 from the 75 total requests currently approved by OMB under the aforementioned control number.
We estimate it will take 10 hours at $89.18/hr for a computer system analyst per arrangement submission to submit this data. In aggregate, we estimate an annual burden of 1,500 hours (150 submissions × 10 hr/submission) at a cost of $133,770 (1,500 hr × $89.18/hr). The increase in the number of clinician-initiated requests results in an adjustment of 750 hours and $66,885 (75 requests × 10 hr × $89.18/hr).
We received no public comments related to the burden estimates for Other Payer Advanced APM Identification Determinations: Eligible Clinician Initiated Process. The burden estimates have not been updated from the CY
The CY 2017 Quality Payment Program final rule provided 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 of patients furnished any service through the arrangement (81 FR 77480). The rule also specified that if we do not receive sufficient information to complete our evaluation of another payer arrangement and to make QP determinations for an eligible clinician using the All-Payer Combination Option, we will not assess the eligible clinicians under the All-Payer Combination Option (81 FR 77480).
In the CY 2018 Quality Payment Program final 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 will need to receive all of the payment amount and patient count information: (1) Attributable to the eligible clinician or APM Entity 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 (82 FR 53885). We also finalized that eligible clinicians and APM Entities will not need to submit Medicare payment or patient information for QP determinations under the All-Payer Combination Option (82 FR 53885).
The CY 2018 Quality Payment Program final rule noted that we will need this payment amount and patient count information for the periods January 1 through March 31, January 1 through June 30, and January 1 through August 31 (82 FR 53885). We noted that the timing may be challenging for APM Entities or eligible clinicians to submit information for the August 31 snapshot date. If we receive information for either the March 31 or June 30 snapshots, but not the August 31 snapshot, we will use that information to make QP determinations under the All-Payer Combination Option. This payment amount and patient count information is to be submitted in a way that allows us to distinguish information from January 1 through March 31, January 1 through June 30, and January 1 through August 31 so that we can make QP determinations based on the two finalized snapshot dates (82 FR 30203 through 30204).
The CY 2018 Quality Payment Program final rule specified 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 53886).
In section III.I.4.e.(5)(b) of this final rule, we are finalizing the addition of a third alternative to allow QP determinations at the TIN level in instances where all clinicians who have reassigned billing rights to the TIN participate in a single (the same) APM Entity. This option will therefore be available to all TINs participating in Full TIN APMs, such as the Medicare Shared Savings Program. It will also be available to any other TIN for which all clinicians who have reassigned billing rights to the TIN participating in a single APM Entity. To make QP determinations under the All-Payer Combination Option at the TIN level as finalized using either the payment amount or patient count method, we will need to receive, by December 1 of the calendar year that is 2 years to prior to the payment year, all of the payment amount and patient count information: (1) Attributable to the eligible clinician, TIN, or APM Entity 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(s) during the QP performance period for the periods January 1 through March 31, January 1 through June 30, and January 1 through August 31.
As shown in Table 87, we assume that 4 APM Entities, 225 TINs, and 80 eligible clinicians will submit data for QP determinations under the All-Payer Combination Option in 2019. We estimate it will take the APM Entity representative, TIN representative, or eligible clinician 5 hours at $107.38/hr for a practice administrator to complete this submission. In aggregate, we estimate an annual burden of 1,545 hours (309 respondents × 5 hr) at a cost of $165,902 (1,545 hr × $107.38/hr).
We received no public comments related to the burden estimates for the Submission of Data for All-Payer QP Determinations. The burden estimates have been updated from the CY 2019 PFS proposed rule to reflect updated respondent estimates (83 FR 36038 through 36039).
This rule does not include any new or revised reporting, recordkeeping, or third-party disclosure requirements related to the election by voluntary participants to opt-out of public reporting on Physician Compare. However, we have adjusted our currently approved burden estimates based on more recent data. The adjusted burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).
We estimate that 10 percent of the total clinicians and groups who will voluntarily participate in MIPS will also elect not to participate in public reporting. This results in a total of 11,617 (10 percent × 116,174 voluntary MIPS participants), a decrease of 10,783 from the total respondents currently approved by OMB under the aforementioned control number due to the reduction in voluntary participation in MIPS overall. As we discussed earlier in this section of the final rule, voluntary respondents are clinicians that are not QPs and are expected to be excluded from MIPS after applying the eligibility requirements discussed in section III.I.3.a. of this final rule, but have elected to submit data to MIPS. In implementing the finalized opt-in policy, we estimate that 33 percent of clinicians that exceed 1 of the low-volume criteria, but not all 3, will elect to opt-in to MIPS, become MIPS eligible, and no longer be considered a voluntary reporter. This logic was also applied in the regulatory impact analysis of this rule. Table 88 shows that for these voluntary participants, we estimate it will take 0.25 hours at $89.18/hr for a computer system analyst to submit a request to opt-out. In aggregate, we estimate an annual burden of 2,904.25 hours (11,617 requests × 0.25 hr/request) at a cost of $259,001 (2,904.25 hr × $89.18/hr).
The decrease in the number of respondents due to policies finalized in this rule results in a decrease of −2,695.75 hours (−10,783 respondents × 0.25 hr) and −$240,407 (−2,695.75 hours × $89.18/hr).
We received no public comments related to the burden estimates for voluntary participants to elect to opt out of performance data display on Physician Compare. However, the burden estimates have not been updated from the CY 2019 PFS proposed rule to reflect availability of data from the 2017 MIPS performance period (83 FR 36039).
Table 89 summarizes this final rule's burden estimates for the Quality Payment Program. 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 2018 Quality Payment Program final rule into the 2019 MIPS performance period. Our baseline burden estimates reflect the recent availability of data sources to more accurately reflect the number of the respondents for the quality, Promoting Interoperability, and improvement activities performance categories and the number of organizations exempt from the Promoting Interoperability performance category.
Table 90 provides the reasons for changes in the estimated burden for information collections in this final rule. We have divided the reasons for
This final rule makes payment and policy changes under the Medicare PFS and implements required statutory changes under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), the Achieving a Better Life Experience Act (ABLE), the Protecting Access to Medicare Act of 2014 (PAMA), section 603 of the Bipartisan Budget Act of 2015, the Consolidated Appropriations Act of 2016, the Bipartisan Budget Act of 2018, and section 2001(a) of the SUPPORT for Patients and Communities Act of 2018. This final rule also makes changes to payment policy and other related policies for Medicare Part B.
This final rule is necessary to make policy changes under Medicare fee-for-service. Therefore, we included a detailed regulatory impact analysis (RIA) to assess all costs and benefits of available regulatory alternatives and explained the selection of these regulatory approaches that we believe adhere to section 1834(q) of the Act and, to the extent feasible, maximize net benefits.
This final rule also makes payment and policy changes under the Medicare PFS and makes required statutory changes under the MACRA, as amended by section 51003 of the Bipartisan Budget Act of 2018.
The new policies for CY 2019 are detailed throughout this final rule. For example, the policies associated with modernizing Medicare physician payment by recognizing communication technology-based services are described in section II.D. of this final rule, while the policies associated with E/M visits are described in section II.I. of this final rule. Several policies addressing the use of innovative technology that enables remote services will expand access to care and create more opportunities for patients to access more personalized care management, as well as connect with their physicians more quickly. These policies support access to care using telecommunications technology by paying clinicians for virtual check-ins (brief, non-face-to-face appointments via communications technology), paying clinicians for evaluation of patient-submitted photos or videos, and
Several policies in the final rule will also give physicians more time to spend with their patients, especially those with complex needs, rather than on paperwork. Specifically, there are provisions that simplify certain documentation requirements for E/M visits, which make up about 40 percent of allowed charges under the PFS and consume much of clinicians' time; reduce supervision requirements for radiologist assistants during diagnostic test services; and remove burdensome and overly complex functional reporting requirements for outpatient therapy. In addition, section VII.H. of this final rule, the RIA, details the economic effect of these policies on Medicare providers and beneficiaries.
We examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (February 2, 2013), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). An RIA must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). We estimated, as discussed in this section, that the PFS policies included in this final rule would redistribute more than $100 million in 1 year. Therefore, we estimate that this rulemaking is “economically significant” as measured by the $100 million threshold, and hence also a major rule under the Congressional Review Act. Accordingly, we prepared an RIA that, to the best of our ability, presents the costs and benefits of the rulemaking. The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals, practitioners and most other providers and suppliers are small entities, either by nonprofit status or by having annual revenues that qualify for small business status under the Small Business Administration standards. (For details see the SBA's website at
The RFA requires that we analyze regulatory options for small businesses and other entities. We prepare a regulatory flexibility analysis unless we certify that a rule would not have a significant economic impact on a substantial number of small entities. The analysis must include a justification concerning the reason action is being taken, the kinds and number of small entities the rule affects, and an explanation of any meaningful options that achieve the objectives with less significant adverse economic impact on the small entities.
Approximately 95 percent of practitioners, other providers, and suppliers are considered to be small entities, based upon the SBA standards. There are over 1 million physicians, other practitioners, and medical suppliers that receive Medicare payment under the PFS. Because many of the affected entities are small entities, the analysis and discussion provided in this section, as well as elsewhere in this final rule is intended to comply with the RFA requirements regarding significant impact on a substantial number of small entities.
For example, the effects of changes to payment rates for practitioners, other providers, and suppliers are discussed in VII.C. of this final rule. Alternative options considered to the payment rates are discussed generally in section VII.F. of this final rule.
In addition, section 1102(b) of the Act requires us to prepare an RIA if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. The PFS does not reimburse for services provided by rural hospitals; the PFS pays for physicians' services, which can be furnished by physicians and non-physician practitioners in a variety of settings, including rural hospitals. We did not prepare an analysis for section 1102(b) of the Act because we determined, and the Secretary certified, that this final rule would not have a significant impact on the operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits on state, local, or tribal governments or on the private sector before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2018, that threshold is approximately $150 million. This final rule will impose no mandates on state, local, or tribal governments or on the private sector.
Executive Order 13132 establishes certain requirements that an agency must meet when it issues a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. Since this regulation does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable.
Executive Order 13771, entitled Reducing Regulation and Controlling Regulatory Costs (82 FR 9339), was issued on January 30, 2017. This final rule is considered an E.O. 13771 deregulatory action because it is expected to result in regulatory cost savings. The estimated impact would be $71 million in cost savings in 2019, $3.986 billion in costs in 2020, $387 million in cost savings in 2021, $450 million cost savings in 2022, and $557 million in cost savings in 2023 and thereafter. Annualizing these costs and cost savings in perpetuity and discounting at 7 percent back to 2016, we estimated that this rule would generate $190 million in annualized net cost savings for E.O. 13771 accounting purposes. Details on the estimated cost savings of this rule can be found in the following analyses.
We prepared the following analysis, which together with the information provided in the rest of this preamble, meets all assessment requirements. The analysis explains the rationale for and purposes of this final rule; details the costs and benefits of the rule; analyzes alternatives; and presents the measures we would use to minimize the burden on small entities. As indicated elsewhere in this final rule, we are implementing a variety of changes to our regulations, payments, or payment policies to ensure that our payment
Section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or decreases in RVUs may not cause the amount of expenditures for the year to differ by more than $20 million from what expenditures would have been in the absence of these changes. If this threshold is exceeded, we make adjustments to preserve budget neutrality.
Our estimates of changes in Medicare expenditures for PFS services compared payment rates for CY 2018 with payment rates for CY 2019 using CY 2017 Medicare utilization. The payment impacts in this final rule reflect averages by specialty based on Medicare utilization. The payment impact for an individual practitioner could vary from the average and would depend on the mix of services he or she furnishes. The average percentage change in total revenues will be less than the impact displayed here because practitioners and other entities generally furnish services to both Medicare and non-Medicare patients. In addition, practitioners and other entities may receive substantial Medicare revenues for services under other Medicare payment systems. For instance, independent laboratories receive approximately 83 percent of their Medicare revenues from clinical laboratory services that are paid under the Clinical Laboratory Fee Schedule (CLFS).
The annual update to the PFS conversion factor (CF) was previously calculated based on a statutory formula; for details about this formula, we refer readers to the CY 2015 PFS final rule with comment period (79 FR 67741 through 67742). Section 101(a) of the MACRA repealed the previous statutory update formula and amended section 1848(d) of the Act to specify the update adjustment factors for CY 2015 and beyond. The update adjustment factor for CY 2019, as required by section 53106 of the Bipartisan Budget Act of 2018, is 0.25 percent before applying other adjustments.
To calculate the CF for this year, we multiplied the product of the current year CF and the update adjustment factor by the budget neutrality adjustment described in the preceding paragraphs. We estimated the CY 2019 PFS CF to be 36.0391 which reflects the budget neutrality adjustment under section 1848(c)(2)(B)(ii)(II) and the 0.25 percent update adjustment factor specified under section 1848(d)(18) of the Act. We estimate the CY 2019 anesthesia CF to be 22.2730, which reflects the same overall PFS adjustments with the addition of anesthesia-specific PE and MP adjustments.
Table 94 shows the payment impact on PFS services of the policies contained in this final rule. To the extent that there are year-to-year changes in the volume and mix of services provided by practitioners, the actual impact on total Medicare revenues would be different from those shown in Table 94 (CY 2019 PFS Estimated Impact on Total Allowed Charges by Specialty). The following is an explanation of the information represented in Table 94.
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The most widespread specialty impacts of the RVU changes are generally related to the changes to RVUs for specific services resulting from the misvalued code initiative, including RVUs for new and revised codes. The estimated impacts for some specialties, including clinical psychologists, vascular surgery, interventional radiology, and podiatry, reflect increases relative to other physician specialties. These increases can largely be attributed to finalized increases in
The estimated impacts for several specialties, including diagnostic testing facilities, independent labs, pathology, and ophthalmology, reflect decreases in payments relative to payment to other physician specialties. These decreases can largely be attributed to revaluation of individual procedures reviewed by the AMA's committee and CMS, decreased payments as a result of finalized updates to supply and equipment pricing, and continued implementation of previously finalized code-level reductions that are being phased-in over several years. We note that the estimated impacts for many specialties differ significantly relative to the estimates included in the proposed rule. These changes reflect changes between the proposed and final policies based on our consideration of public comments. We note that the most significant of these changes relates to the various elements of the proposed changes in coding and payment for office/outpatient E/M visits, none of which are being finalized for CY 2019. For independent laboratories, it is important to note that these entities receive approximately 83 percent of their Medicare revenues from services that are paid under the CLFS. As a result, the estimated 2 percent reduction for CY 2019 is only applicable to approximately 17 percent of the Medicare payment to these entities.
We often receive comments regarding the changes in RVUs displayed on the specialty impact table (Table 94), including comments received in response to the proposed rates. We remind stakeholders that although the estimated impacts are displayed at the specialty level, typically the changes are driven by the valuation of a relatively small number of new and/or potentially misvalued codes. The percentages in Table 94 are based upon aggregate estimated PFS allowed charges summed across all services furnished by physicians, practitioners, and suppliers within a specialty to arrive at the total allowed charges for the specialty, and compared to the same summed total from the previous calendar year. Therefore, they are averages, and may not necessarily be representative of what is happening to the particular services furnished by a single practitioner within any given specialty.
Column F of Table 94 displays the estimated CY 2019 impact on total allowed charges, by specialty, of all the RVU changes. A table showing the estimated impact of all of the changes on total payments for selected high volume procedures is available under “downloads” on the CY 2019 PFS final rule website at
Although we are not finalizing changes to E/M coding and payment for CY 2019, we are finalizing certain changes for CY 2021. We provide the following impact estimate only for illustrative purposes. Table 95 illustrates the estimated specialty level impacts associated with implementing our finalized policies for E/M coding and payment in CY 2019, rather than delaying until CY 2021. Table 24C shows the estimated impacts of adopting single payment rates for new and established patient E/M visit levels 2-4 (with the rates determined using input values that reflect the weighted average of 2018 inputs for codes describing those visit levels), keeping separate rates for new and established patient E/M visit level 5 (with the rates determined using the 2018 input values for level 5 visits), and adopting add-on codes with equal rates to adjust for the inherent visit complexity of primary care and non-procedural specialty care (with the rates determined using the input values from the proposed rule for the non-procedural specialty care complexity code).
Under our finalized policies, specialties that disproportionately report lower level visits, such as podiatry, and specialties that report office/outpatient visits in conjunction with minor procedures, such as dermatology, would see significant increases. Specialties that predominantly furnish higher level visits would have their negative redistribution significantly mitigated by the maintenance of the level 5 visit and the add-on codes for inherent visit complexity for primary and non-procedural specialty care.
We note that our original proposal was developed more generally to maintain overall RVUs within the codes describing office/outpatient visits, but, after consideration of public comments, we are not finalizing several elements of those proposals, including and especially the multiple procedure payment reduction. As a result, implementation with the values and policies as altered, would require off-setting reductions in overall PFS payments. Following our current methodology, these reductions, required by statute, would be applied through a budget neutrality adjustment in the PFS CF, consistent with our established methodology. As a result of such an adjustment, specialties that do not furnish office/outpatient visits generally would see overall reductions in payment of approximately 2.0 percent, as generally reflected in the Table 95. Given that overall payment for the office/outpatient E/M codes would increase, and because these services are reported by most specialities, the overall changes for most specialties are generally offsetting. However, for physician specialties and suppliers that do not report office/outpatient E/M services, the reduction would be approximately −2.0 percent.
As discussed in section II.H., of this final rule, based on the statements by commenters that the medical community, through the CPT process, has committed itself to considering revisions to the office/outpatient visit codes and given the history of collaboration between CMS and the medical community, we expect to consider any possible changes in CPT coding, as well as recommendations regarding valuation for services, from the RUC and other stakeholders, through our annual rulemaking process, between now and implementation for
With regard to the documentation policies we are finalizing for CY 2021, our intent is to allow clinicians a choice in how levels 2 through 5 visits are documented—using current framework, MDM or time. Assuming the current code set for E/M office/outpatient visits is maintained for CY 2021, when a level 2 through 4 visit (which comprises the majority of visits currently furnished) is documented using the current framework or MDM, documentation will be simplified by applying a minimum level 2 documentation standard to level 2 through 4 visits. When a level 2 through 4 visit is documented using time, practitioners should report the appropriate code based on the time defined as typical under the CPT code descriptors for office/outpatient E/M visits. Practitioners will be required to document that the visit was medically necessary and the billing practitioner spent at least the amount of time included in the CPT as typical face-to-face with the patient. The extended visit code can be reported with a level 2 through 4 visit when the time of the overall visit is between 34 and 69 minutes (for established patients) and between 38 and 89 minutes (for new patients) of face-to-face time with the billing practitioner. (See section II.I. of this final rule. For example, a level 2 through 4 extended visit will require the billing practitioner to spend and document that he or she spent at least 35 minutes face-to-face with the patient. We are also finalizing a policy to require minimal documentation to support reporting of the add-on codes that we are finalizing for use with the level 2 through 4 visit codes. These add-on codes are to reflect the inherent complexity in E/M services for primary care, and for other non-procedural specialty care, and for extended visits).
For level 5 E/M visits, again assuming the current code set remains in place for CY 2021, we will allow the visit to be documented using the current framework, MDM or time. When documenting using MDM, the current definition of level 5 MDM will apply. When documenting a level 5 visit using time, we will require the billing practitioner to document that they spent at least the typical time for the reported level 5 CPT code, face-to-face with the patient (currently 40 minutes for an established patient and 60 minutes for a new patient). The add-on codes that we are finalizing for use with the level 2 through 4 visits (the inherent complexity add-on codes for primary care and other non-procedural specialty care and extended visits) will not be reportable with level 5 visits. We note that the current coding for prolonged visits would continue to be reportable with level 5 visits.
As discussed elsewhere in this section of the final rule, we estimate this approach would lead to significant burden reduction for practitioners, while allowing preparatory time and time for potential refinement over the next few years as we take into account any feedback from stakeholders on these changes, as well as any potential revisions to the E/M code set.
As discussed in section II.D. of this final rule, we are adding two new codes, HCPCS codes G0513 and G0514, to the list of Medicare telehealth services. Although we expect these changes to have the potential to increase access to care in rural areas, based on recent telehealth utilization of services already on the list, including services similar to the proposed additions, we estimate there will only be a negligible impact on PFS expenditures from these additions. For example, for services already on the list, they are furnished via telehealth, on average, less than 0.1 percent of the time they are reported overall. This addition was responsive to longstanding stakeholder interest in expanding Medicare payment for telehealth services. The restrictions placed on Medicare telehealth by the statute limit the magnitude of utilization; however, we believe there is value in allowing physicians and patients the greatest flexibility when appropriate.
As discussed in section II.G. of this final rule, we are finalizing a PFS Relativity Adjuster of 40 percent for CY 2019, meaning that nonexcepted items and services furnished by nonexcepted off-campus PBDs will be paid under the PFS at a rate that is 40 percent of the OPPS rate. In finalizing our policy to maintain the PFS Relativity Adjuster at 40 percent, we updated our analysis to include a full year of claims data. We estimated site-specific PFS rates for the technical component of a service for the entire range of HCPCS codes furnished in nonexcepted off campus PBDs. Next we compared the sum of the site-specific payment rates under the PFS, weighted by OPPS claims volume, to the sum of payment rates under the OPPS, also weighted by OPPS claims volume. This calculation resulted in a relative rate of approximately 40 percent, supporting our policy to maintain the PFS Relativity Adjuster at 40 percent. We are finalizing the PFS Relativity Adjuster of 40 percent, as proposed. There will be no additional savings for CY 2019 relative to CY 2018 because we are maintaining the current PFS Relativity Adjuster of 40 percent, which was finalized for CY 2018.
In section II.M. of this final rule, we finalized the following policy: Effective January 1, 2019, Wholesale Acquisition Cost (WAC)-based payments for Part B drugs made under section 1847A(c)(4) of the Act will utilize a 3 percent add-on in place of the 6 percent add-on that is currently being used. We also will permit Medicare Administrative Contractors (MACs) to use an add-on percentage of up to 3 percent for WAC-based payments for new drugs.
We anticipate that the reduction to the add-on payment made for a subset of Part B drugs will result in savings to the Medicare program. The 3 percent add-on is consistent with MedPAC's analysis and recommendations, as well as discounts observed by MedPAC in their June 2017 Report to the Congress. We have also considered how CMS' experience with WAC-based pricing for recently marketed new drugs and biologicals compares to MedPAC's findings. Although the number of new drugs that are priced using WAC is very limited, the average difference between WAC and Average Sales Price (ASP)-based payment limits for a group of 3 recently approved drugs and biologicals that appeared on the ASP Drug Pricing Files (including one biosimilar biological product) was 9.0 percent. Excluding the biosimilar biological product results in a difference of 3.5 percent. The difference was determined by comparing a partial quarter WAC-based payment amount determined
Although we are able to provide examples of the relative differences between ASP and WAC based payment limits, and we anticipate some savings from the change in policy, we cannot estimate the magnitude of savings over time because we cannot determine how many new drugs and biologicals subject to partial quarter pricing will appear on the ASP Drug Pricing files in the future or how many Part B claims for these products will be paid. This limitation also applies to contractor-priced drugs and biologicals that have HCPCS codes and are in their first quarter of sales. Finally, the claims volume for contractor-priced drugs and biologicals that are billed using miscellaneous or Not Otherwise Classified codes, such as J3490 and J3590, cannot be quantified. We would like to note that for the three drugs discussed in the preceding paragraph, Medicare Part B payments for individual doses of each drug range from approximately $3,000 to $10,000. The payment changes finalized in this rule would result in a little less than $100 to $300 savings in Medicare allowed charges for each dose.
Although we cannot estimate the overall savings to the Medicare Program or to beneficiaries, we would like to note that this change in policy is likely to decrease copayments for individual beneficiaries who are prescribed new drugs. Given that launch prices for single doses for some new drugs may range from tens to hundreds of thousands of dollars, a 3 percentage point reduction in the total payment allowance will reduce a patient's 20 percent Medicare Part B copayment. This reduction can result in savings to an individual beneficiary and can help Medicare beneficiaries particularly those without supplementary insurance, afford to pay for new drugs by reducing out of pocket expenses.
The 3 percent add-on is expected to reduce the difference between acquisition cost and certain WAC-based Part B drug payments. Based on MedPAC's June 2017 Report to Congress, and for reasons discussed in section II.M. of this rule, we do not anticipate that this change will result in payments amounts that are below acquisition cost or that the new policy will impair providers or patients' access to Part B drugs.
As discussed in section III B.2. of this final rule, section 50203(a) of the Bipartisan Budget Act of 2018 amended section 1834(l)(12)(A) and (l)(13)(A) of the Act to extend the payment add-ons set forth in those subsections through December 31, 2022. The ambulance extender provisions are enacted through legislation that is self-implementing. A plain reading of the statute requires only a ministerial application of the mandated rate increase and does not require any substantive exercise of discretion on the part of the Secretary. As a result, there were no policy proposals associated with these legislative provisions or associated impact in this rule. We are finalizing our proposal without modification to revise the dates in § 414.610(c)(1)(ii) and (c)(5)(ii) to conform the regulations to these self-implementing statutory requirements.
In addition, as discussed in section III.B.3. of this final rule, section 53108 of the BBA amended section 1834(l)(15) of the Act to increase the payment reduction from 10 percent to 23 percent effective for ambulance services furnished on or after October 1, 2018 consisting of non-emergency basic life support services involving transports of an individual with end stage renal disease for renal dialysis services furnished other than on an emergency basis by a provider of services or a renal dialysis facility. The 10 percent reduction applies for such ambulance services furnished during the period beginning on October 1, 2013 and ending on September 30, 2018.
This statutory requirement is self-implementing. A plain reading of the statute requires only a ministerial application of the mandated rate decrease and does not require any substantive exercise of discretion on the part of the Secretary. As a result, there were no policy proposals associated with these legislative provisions or associated impact in this rule. We are finalizing our proposal without modification to revise § 414.610(c)(8) to conform the regulations to this self-implementing statutory requirement.
As discussed in section III. A. of this final rule, section 1834A of the Act, as established by section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA), required significant changes to how Medicare pays for Clinical Diagnostic Laboratory Tests (CDLTs) under the Clinical Laboratory Fee Schedule (CLFS). The CLFS final rule titled, Medicare Clinical Diagnostic Laboratory Tests Payment System final rule, published in the
An applicable laboratory is defined at § 414.502, in part, as an entity that is a laboratory (as defined under the Clinical Laboratory Improvement Amendments (CLIA) definition at § 493.2) that bills Medicare Part B under its own National Provider Identifier (NPI). In addition, an applicable laboratory is an entity that receives more than 50 percent of its Medicare revenues during a data collection period from the CLFS and/or the PFS. We refer to this component of the applicable laboratory definition as the “majority of Medicare revenues threshold.” The definition of applicable laboratory also includes a “low expenditure threshold” component which requires an entity to receive at least $12,500 of its Medicare revenues from the CLFS during a data collection period, for its CDLTs that are not advanced diagnostic laboratory tests (ADLTs).
In determining payment rates under the private payor rate-based CLFS, one of our objectives is to obtain as much applicable information as possible from the broadest possible representation of the national laboratory market on which to base CLFS payment amounts, for example, from independent laboratories, hospital outreach laboratories, and physician office laboratories, without imposing undue burden on those entities. We believe it is important to achieve a balance between collecting sufficient data to calculate a weighted median that appropriately reflects the private market rate for a CDLT, and minimizing the reporting burden for entities. In response to stakeholder feedback and in the interest of facilitating this objective, we are finalizing the revision to the majority of
Therefore, in response to stakeholder feedback and in the interest of obtaining as much applicable information as possible, we are finalizing the revision of the definition of applicable laboratory at § 414.502 to include a hospital laboratory that bills Medicare on the Form CMS-1450 14x bill type and its electronic equivalent. For a complete discussion of this revision to the definition of applicable laboratory under the Medicare CLFS, we refer readers to section III.A. of this final rule.
To estimate the potential impact of excluding MA plan payments from total Medicare revenues (that is, the denominator of the low expenditure threshold) on the number of laboratories meeting the majority of Medicare revenues threshold, using CY 2017 Medicare claims data, we compared the number of billing NPIs that would have met the majority of Medicare revenues threshold with MA plan revenues included in total Medicare revenues (which is the current requirement) versus the number of billing NPIs that would meet the majority of Medicare revenues threshold had MA plan payments been
Our summary analysis of data reporting from the initial data reporting period under the Medicare CLFS private payor rate-based payment system, indicates that we received applicable information from 1,942 applicable laboratories and they reported over 4.9 million records. Applying the projected 49 percent increase to the number of applicable laboratories from the first data reporting period (1,942 × 1.49) yields an estimated 2,893 laboratories that would meet the majority of Medicare revenues threshold, which reflects an additional 951 laboratories. Provided all other requirements for applicable laboratory status are met (including the low expenditure threshold of receiving at least $12,500 in CLFS revenues during a data collection period) a laboratory would report applicable information for the next data reporting period.
To determine the estimated reporting burden for an applicable laboratory, we looked at the distribution of reported records that occurred for the first data reporting period. The average number of records reported for an applicable laboratory for the first data reporting period was 2,573. The largest amount of records reported for an applicable laboratory was 457,585 while the smallest amount reported was 1 record. A summary of the distribution of reported records from the first data collection period is illustrated in the Table 96.
Presuming that all of the additional laboratories that are projected to meet the majority of Medicare revenues threshold, that is approximately 951, also meet all of the criteria necessary to receive applicable laboratory status, as defined at § 414.502, they would be an applicable laboratory and report applicable information for the next data reporting period, January 1, 2020 through March 31, 2020. Using the mid-point of the percentile distribution of reported records from the initial data reporting period, that is approximately 300 records reported per applicable laboratory (50th percentile for the first data reporting period was 294), we estimate an additional 285,300 records would be reported for the next data reporting period (951 laboratories × 300 records per laboratory = 285,300). This represents an increase in data reporting of about 5 percent over the number of records reported for the initial data reporting period (285,300 additional records/4,995,877 = 0.05). In other words, using the approximate mid-point of reported records for the first data reporting period, we estimate that our proposed change to the majority of Medicare revenues threshold would increase the total amount of records reported by approximately 5 percent. As illustrated in Table 96, the number of records reported varies greatly, depending on the volume of services performed by a given laboratory. Laboratories with larger test volumes, for instance at the 90th percentile, should expect to report more records as compared to the midpoint used for this analysis. Laboratories with smaller test volume, for instance at the 10th percentile, should expect to report fewer records as compared to the midpoint.
We estimate that the inclusion of 14X type of bills would yield an increase of 39 percent in the total number of laboratories meeting the majority of Medicare revenues threshold. Applying the projected 39 percent increase to the number of applicable laboratories from the first data reporting period (1,942 × 1.39) yielded an estimated 2,699 laboratories that would meet the majority of Medicare revenues threshold, which reflects approximately
We note that there would only be an associated Medicare cost or savings to the extent that the additional applicable laboratories are paid at a higher or lower private payor rate, as compared to other laboratories that reported previously, and only to the extent that the volume of services performed by these “additional” applicable laboratories is significant enough to make an impact on the weighted median of private payor rates. We have no reason to believe that increasing the level of participation, either by excluding MA plan payments from total Medicare revenues or including laboratories that bill Medicare Part B on the Form CMS-1450 14x bill type would result in a measurable cost difference under the CLFS. Given that the largest laboratories with the highest test volumes, by definition, dominate the weighted median of private payor rates, and that the largest laboratories reported data for the determination of CY 2018 CLFS rates and are expected to report again, we do not expect the additional reported data resulting from our proposed change to the majority of Medicare revenues threshold to have a predictable, direct impact on CLFS rates because of the reasons stated above. However, we believe that this proposal responds directly to stakeholder concerns regarding the number of applicable laboratories reporting applicable information for the initial data reporting period. Therefore, in an effort to increase the number of laboratories qualifying for applicable laboratory status, we are finalizing a change to the majority of Medicare revenues threshold so that laboratories furnishing tests to a significant level of Medicare Part C enrollees may qualify as applicable laboratories and report data to us. In addition, as part of the same effort to increase the number of laboratories qualifying for applicable laboratory status, we are finalizing a change in the definition of applicable laboratory to include an entity that bills Medicare Part B on the Form CMS-1450 14x bill type. We note that other laboratory types, such as independent laboratories and physician office laboratories, are required under the current definition of an applicable laboratory to determine applicable laboratory status and must report applicable information. The use of Form CMS-1450 14x TOB to define an applicable laboratory would assist hospital outreach laboratories to comply with their obligation to assess applicable laboratory status for any outreach laboratories and report applicable information if they meet the requirements to be an applicable laboratory. As such, the hospital could use the revenues from the CLFS and PFS as the numerator compared to the total revenues for the 14X TOB to determine applicable laboratory status. Alternatively, a hospital could get an NPI for its outreach laboratory.
Section 1834(q)(2) of the Act, as added by section 218(b) of the PAMA, established a program to promote the use of AUC for applicable imaging services furnished in an applicable setting. The CY 2016 PFS final rule with comment period established an evidence-based process and transparency requirements for the development of AUC and stated that the AUC development process requirements, as well as the application process that organizations must comply with to become qualified provider-led entities (PLEs) did not impact CY 2016 physician payments under the PFS (80 FR 71362). The CY 2017 PFS final rule identified the requirements clinical decision support mechanisms (CDSMs) must meet for qualification and stated that the CDSM requirements, as well as the application process that CDSM developers must comply with for their mechanisms to be specified as qualified under this program, did not impact CY 2017 physician payments under the PFS (81 FR 80546). The CY 2018 PFS final rule established the effective date of January 1, 2020, on which the AUC consulting and reporting requirements will begin, and extended the voluntary consulting and reporting period to 18 months. Therefore, we stated these proposals did not impact CY 2018 physician payments under the PFS (82 FR 53349) and noted we would provide an impact statement when applicable in future rulemaking.
This final rule modifies the Medicare AUC Program and addresses the impacts related to the actions taken by ordering professionals who order advanced diagnostic imaging services and those who furnish the advanced diagnostic imaging services, including the professional and technical portions of the services. We finalized a modification to the AUC consultation requirement for ordering professionals
This final rule includes a discussion of the proposed options along with the final policy to report the required claims-based AUC consultation information in the form of G-codes and HCPCS modifiers. We estimated the impact to use existing coding methods (G-codes and HCPCS modifiers) to report that information. Finally, we measured the estimated impact on furnishing professionals and facilities of the finalized proposal to include independent diagnostic testing facilities (IDTFs) as an applicable setting in § 414.94(b). While the AUC consultation and reporting requirements of this program are effective beginning January 1, 2020 with an educational and operations testing period, we attempt in this analysis to identify areas of potential qualitative benefits to both Medicare beneficiaries and the Medicare program.
In this final rule, we modified the AUC program largely in response to public comments and recommendations as we believe these modifications are also important in minimizing burden of the AUC program on ordering professionals, furnishing professionals, and facilities. Specifically, we included a proposal regarding who, other than the ordering professional, may conduct the AUC consultation through a qualified CDSM and still meet the requirements of our regulations. In the CY 2018 PFS final rule (82 FR 53349), we based our estimate for the AUC consultation requirement on the 2 minute effort of a family and general practitioner resulting in an annual burden of 1,425,000 hours (43,181,818 consultations (Part B analytics 2014 claims data) × 0.033 hr/consultation) at a cost of $275,139,000.
An important difference from last year's analysis is that this year's analysis includes estimates for non-physician practitioners that order advanced diagnostic imaging services. For the purposes of this analysis, we assumed that orders for advanced diagnostic imaging services will be placed by ordering professionals that are non-physician practitioners in the same percent as the numbers of non-physician practitioners are relative to the total number of non-institutional providers. Therefore, this analysis assumed that 40 percent of all advanced diagnostic imaging services will be ordered by non-physician practitioners. While non-physician practitioners may not order advanced diagnostic imaging services in the same proportion as their numbers, we did not have other data to use for this estimate. We specifically solicited comment and data on alternative assumptions about the number of non-physician practitioners who order advanced imaging services. We did not receive comments on this aspect of our estimate.
In addition, we had proposed, but did not finalize, that auxiliary personnel may perform the AUC consultation when under the direction of, and incident to, the ordering professional's services. We finalized that the AUC consultation task may be delegated by the ordering professional to clinical staff under the direction of the ordering professional. The final estimate below, after taking into account public comments, is applicable given the change in policy from proposed rule to final rule. In the CY 2019 PFS proposed rule, we estimated that the majority, or as many as 90 percent, of practices will employ the use of auxiliary personnel, working under the direction of the ordering professional, to interact with the CDSM for AUC consultation for advanced diagnostic imaging orders. We also considered leaving the policy unchanged, and smaller modifications to that could expand who performs the consultation to a single type of non-physician practitioner. We originally proposed this modification because we believed it maximized burden reduction effort as illustrated in the following updated estimate of consultation burden.
To estimate the burden of this proposed policy, we calculated the effort of a 2-minute consultation with a qualified CDSM by a registered nurse (occupation code 29-1141) with mean hourly wage of $35.36 and 100 percent fringe benefits to be $2.33/consultation ($35.36/hour × 2 × 0.033 hour). If 90 percent of AUC consultations (1,282,500 hours) are performed by auxiliary personnel as proposed then annually the burden estimate would be $90,698,400 (1,282,500 hours × $70.72/hour) to consult. We acknowledged that some AUC consultations will be performed by the ordering professional, therefore the remaining total annual burden we estimated was $28,576,950 for the consultation requirement as it was proposed. As a result of these assumptions and calculations, we estimated a reduction in the burden of the statutorily required AUC consultation burden from $275,139,000 (as fully discussed in the CY 2018 PFS final rule) to $122,508,675, which resulted in a net burden reduction of $152,630,325.
The following is a summary of the comments we received on the proposed estimated impact of consultations by ordering professionals.
After considering the comments, we are updating the proposed impact estimate of consultations by ordering professionals. First, we modified our calculation of the effort by a registered nurse to the effort of a 2-minute consultation with a qualified CDSM by a medical assistant (occupation code 31-9092) with mean hourly wage of $16.15 and 100 percent fringe benefits
In section VII.G. of this RIA, Alternatives Considered, we provide a detailed estimate of the burden of an ordering professional voluntarily choosing to consult a second, free CDSM for 300,717 services annually. If 90 percent of those consultations (300,717 services × 90 percent × 0.033 hr/service) for 8,931.285 total hours were performed by a medical assistant at a rate of $32.30/hour for a total of $288,480.50 (8,931.285 × $32.30/hour) and 10 percent of consultations (300,717 services × 10 percent × 0.033 hr/service) for 992.376 total hours were performed by the ordering professional at a rate of $200.54/hour for a total of $199,011.08 then annually the burden estimate would be 9,923.661 total hours (8,931.285 hours + 992.376 hours) and $487,491.58 ($288,480.50 + $199,011.08) to perform the second consultation.
We also estimated the burden of this one-time effort to undertake educational training activities related to the impact of consultations by ordering professionals. As a result we have included the time and effort of a general practitioner (occupation code 29-1062) with mean hourly wage of $100.27 plus 100-percent to account for fringe benefits to attend a one-time, 1.0 hour training. Based on our proposed estimate in section VII.F.4.b. of this RIA, if 579,687 ordering professionals are subject to this program, and all attend training for the same amount of time, then we estimate the total one-time burden of education and training to be $116,250,431 ($200.54/hr × 1.0 hour × 579,687). Since not all physicians would undertake educational training activities, this estimate should be considered an upper bound.
We previously identified significant hardship exceptions to the requirement that ordering professionals consult specified applicable AUC when ordering applicable imaging services (81 FR 80170). Our original intention was to design the AUC hardship exception process in alignment with the EHR Incentive Program and then the MIPS ACI performance category (now Promoting Interoperability). However, in this final rule, we modified the significant hardship exception criteria under § 414.94(i)(3) to be specific to the Medicare AUC program and independent of other Medicare programs both in policy and process. Specifically, we finalized the policy that all ordering professionals self-attest if they are experiencing a significant hardship at the time of placing an advanced diagnostic imaging order. Since the Medicare EHR Incentive Program has ended and we are unable to continue referring to a regulation that is no longer in effect, we did not consider leaving this policy unchanged. We also considered using a significant hardship application submission process. However, we believe that the self-attestation process maximizes burden reduction effort as illustrated in the following updated estimate of ordering professionals subject to an AUC consultation burden.
To estimate the impact of our modification and create a hardship exception specific to this program we attempted to identify how many ordering professionals would be subject to this program.
Medicare non-institutional Part B claims for the first 6 months of 2014 shows that for claims for an advanced diagnostic imaging service that listed an NPI for the ordering/referring provider, up to 90-percent of claims include only 18 different provider specialties. These specialties include: Emergency Medicine; Internal Medicine; Family Practice; Cardiology; Hematology/Oncology; Orthopedic Surgery; Neurology; Urology; Physician Assistant; Nurse Practitioner; Pulmonary Disease; General Surgery; Neurosurgery; Medical Oncology; Gastroenterology; Radiation Oncology; Otolaryngology; and Diagnostic Radiology. We then used CMS data that served to create Table II.8 of the 2014 Medicare Statistics Book and were able to identify how many practitioners in each of those specialties were participating in Medicare program. Table II.8 of the 2014 Medicare Statistics Book combines many of these specialties into higher level groupings and displays the total number of practitioners participating in the Medicare program. However, we used more granular information that identifies the number of practitioners participating in the Medicare program by an individual specialty rather than higher level groupings (table available at
Using this more specific data for the 18 specialties, we estimate the count of practitioners that will be ordering professionals under the AUC program to be 586,386. There are limitations as we do not have data on the actual number of practitioners who order advanced diagnostic imaging services because information about the ordering professional is not currently required to be included on the Medicare claim form for advanced diagnostic imaging services.
In the absence of data on the breadth of professionals who would be required to consult AUC, we assumed that all professionals in the specialties listed earlier could potentially be subject to these requirements because some professionals within a specialty may order these imaging services. We specifically requested comments and data on the numbers of professionals in the specialties that actually order advanced imaging services. We did not receive comments on this estimate.
With respect to the significant hardship exceptions, based on 2016 data from the Medicare EHR Incentive Program and the 2019 payment year MIPS eligibility and special status file, we estimated that 6,699 respondents in the form of 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. For the purposes of this analysis, we cautiously estimated that each of the 6,699 respondents represents a unique ordering professional and that all respondents who experience extreme and uncontrollable circumstances or have an EHR that is decertified are ordering professionals who would self-attest to a significant hardship exception under the AUC program. Nevertheless, we have used this information to update our estimate that there are 579,687 ordering professionals subject to this program.
We believe that the proposed significant hardship exception at
Third, any application or case-by-case determination would necessitate immediate infrastructure development by CMS directly or through one or more MACs, which adds burden and impact to this program. Finally, the proposed self-attestation process requires no verification on the part of the furnishing professional or facility required to report AUC consultation information on the Medicare claim, thus minimizing burden for both ordering professionals, furnishing professionals and facilities. While some of the efficiencies gained from a self-attestation process are qualitative in nature and difficult to measure, such as the streamlined reporting, we believe that relative to other regulatory approaches this proposal uses a least burdensome approach.
We recognize that ordering professionals would store documentation supporting the self-attestation of a significant hardship. Storage of this information could involve the use of automated, electronic, or other forms of information technology at the discretion of the ordering professional. We estimated that the average time for office clerical activities associated with this task to be 10 minutes. To estimate the burden of this storage, we expected that a Bureau of Labor Statistics (BLS) occupation title 43-6013 Medical Secretary with a mean hourly rate of $17.25 and 100-percent fringe benefits would result in a calculated effort of 10 minutes of clerical work to be $5.76 ($17.25/hour × 2 × 0.167 hour). If 6,699 separate ordering professionals require that a Medical Secretary perform the same clerical activity on an annual basis, then this equates to a cost of approximately $38,596 per year. We solicited comment to inform these burden estimates. We did not receive comments on these burden estimates and have finalized these estimates as proposed.
Although we have already discussed the time and effort to consult specified applicable AUC through a qualified CDSM here and in previous rulemaking (81 FR 80170), we believe the impact of this program is extensive as it will apply to every advanced diagnostic imaging service (for example, magnetic resonance imaging (MRI), computed tomography (CT) or positron emission tomography (PET)). Therefore, we also have described in this detailed analysis the estimated impacts of AUC consultation beyond the act of consulting specified applicable AUC which would be an upper bound.
The first additional impact we identified is upstream in the workflow of the AUC consultation and represents the acquisition cost, training, and maintenance of a qualified CDSM. These tools may be modules within or available through certified EHR technology (as defined in section 1848(o)(4)) of the Act or private sector mechanisms independent from certified EHR technology or established by the Secretary. Currently, none are established by the Secretary. Additionally, for the purposes of this program, as required by statute, one or more of such mechanisms is available free of charge. For this impact analysis we will illustrate three potential scenarios as low, medium, and higher burden assessments of this consultation requirement. First, we assume that some number of ordering professionals consults a qualified CDSM available free of charge. Second, we assume that some number purchase a qualified CDSM to integrate within an existing EHR system. Third, we assume that some do not currently have an EHR system and, as a result of the statutory requirement to consult with AUC, would purchase an EHR system with an integrated qualified CDSM to consult specified applicable AUC for the purposes of this program.
In the lowest estimate of burden, every AUC consultation would take place using a qualified CDSM available free of charge integrated into an EHR system and add no additional cost to the requirement in § 414.94(j) of this final rule. While we did not base this estimate on absolute behaviors by all those who have ordered advanced diagnostic imaging services, we believe it is reasonable to estimate that as many as 75 percent of an assumed annual 40,000,000 orders for advanced diagnostic imaging services could occur at no additional cost beyond the time and effort to perform the consultation. This may be an underestimate of orders that occur at no additional cost beyond time and effort because multiple free qualified CDSMs are available.
In contrast, some ordering professionals may voluntarily choose to purchase a qualified CDSM that is integrated within their EHR. To estimate how many ordering professionals may choose to purchase an integrated qualified CDSM, we consulted the 2015 National Electronic Health Records Survey
Again, as stated above, we do not have data on the number of clinicians who order advanced diagnostic imaging services, and we have made overarching assumptions to look at particular specialty areas that in our claims analysis order these advanced diagnostic imaging services. We assumed all individual clinicians in these specialty areas could potentially be subject to these requirements. Adding the number of clinicians in each of the specialty areas results in 586,386 ordering professionals. We also did not make a distinction between individual
To calculate the impact of a single purchase, we believe based on market research that ordering professionals, either in groups or individually, would spend an estimated $15,000 for a one-time purchase of an integrated qualified CDSM, including installation and training. We assume that all of these costs are based on market research and incurred over the course of 5 years. We also assume that the $15,000 purchase would be made by each ordering professional and did not take into account the potential that a group practice might incur a discounted price per user based on the number of ordering professionals in the practice. These assumptions could significantly alter the impact estimate and we sought comment on such assumptions. Given the difficult nature of deriving these illustrative estimates based on limited data, we solicited comment and information on the preference that physicians and practitioners might have for using an integrated qualified CDSM—a free CDSM or a CDSM that is not free but integrated within an existing EHR system. Also, if purchased, whether this would be purchased at the group practice level to be made available to all clinicians in the practice for the same cost that would be incurred by a single practitioner purchasing the same qualified CDSM, and whether the cost of purchasing a CDSM would be incurred in a single year or over multiple years.
For the purposes of estimating the transfer of costs from ordering professionals to qualified CDSM developers, of the estimated 579,687 practitioners that are likely subject to this program, we excluded 181,653 ordering professionals with specialties whose practitioners order on average fewer than 20 advanced diagnostic imaging services per year (physician assistant, nurse practitioner, and diagnostic radiology). The assumption is that lower volume ordering professionals would select a qualified CDSM that is free of charge. This updates the estimate to consider 398,034 ordering professionals who may purchase an integrated qualified CDSM. To this end, if we assume 346,290 (398,034 ordering professionals × 87 percent) ordering professionals already have an EHR system and 30 percent of these ordering professionals (346,290 × 30 percent, or 103,887) make this purchase for $15,000 and spend $1,000 annually to maintain their system for 5 years (initial acquisition cost in year 1 and maintenance costs in years 2-5), then the total annual cost is estimated to be $394,770,600 ((103,887 × $19,000)/5 years)).
It is also reasonable to assume that some ordering professionals may not need additional training in using a qualified CDSM because the EHR Incentive Program required CDS as a core measure. In addition, the EHR Incentive Program incentivized use of computerized provider order entry (CPOE)—an electronic submission of pharmacy, laboratory, or radiology orders. To determine readiness among Medicare practitioners for these and other measures, the 2011 Meaningful Use Census
Additionally, some ordering professionals may voluntarily choose to purchase a certified EHR system to use a qualified CDSM already integrated within the EHR. The first estimate of capital costs for certified EHR system was identified in the first year of the EHR incentive program as an estimated cost of approximately $54,000 (75 FR 44518), which adjusted for inflation using the Consumer Price Index for All Urban Consumers (CPI-U) U.S. city average series for all items, not seasonally adjusted, represents $62,050.40 in 2018. If we assume that 346,290 ordering professionals subject to this program have adopted EHR, then we will also assume that 51,744 ordering professionals (398,034 ordering professionals × 13 percent) have not adopted an EHR system.
Most physicians who have not yet invested in the hardware, software, testing, and training to implement EHRs may continue to work outside the EHR for a number of reasons—lack of standards, lack of interoperability, limited physician acceptance among their peers, maintenance costs, and lack of capital. Adoption of EHR technology necessitates major changes in business processes and practices throughout a provider's office or facility. Business process reengineering on such a scale is not undertaken lightly. Therefore, while we cannot estimate the business decisions of all ordering professionals, we assume for the purposes of this analysis that as a result of this program some ordering professionals will purchase an EHR system in order to access a qualified CDSM that is integrated into that EHR system for the purposes of acquiring long-term process efficiencies in consulting specified applicable AUC.
We do not have data on the characteristics of physicians who have not purchased an EHR system. However, for the purpose of estimating the transfer of costs from ordering professionals to EHR systems, we will assume based on research from business advisors
We recognize that due to the limited data available to make these assumptions our estimates are likely high and we sought comment and information about these assumptions. These estimates might be viewed as an upper bound of the impact of this program beyond consultation with a free tool and note that at the time of publication there were three free tools available as indicated on the CMS website at
Additionally, we believe that the additional 2-minute consultation will impact the Medicare beneficiary when their advanced diagnostic imaging service is ordered by the ordering professional by introducing additional time to their office visit. To estimate this annual cost, we multiplied the annual burden of 1,425,000 hours by the BLS occupation code that represents all occupations in the BLS (00-0000) as mean hourly wage plus 100 percent fringe ($47.72/hr) for a total estimate of $68,001,000 per year. Over time, there may be process efficiencies implemented in one or more practices similar to the benefits of deploying CDS
The following is a summary of the comments we received on the proposed estimated impact of consultations beyond ordering professionals.
After reviewing all comments, for purposes of this RIA we are finalizing our proposed estimate representing the acquisition cost, and maintenance of a qualified CDSM. However, we note that these estimates are based on multiple assumptions, which could change the estimate in significant ways, and as such may be an overestimate of burden as a free qualified CDSM is required by law.
In the CY 2018 PFS proposed rule (82 FR 34094), we discussed using a combination of G-codes and modifiers to report the AUC consultation information on the Medicare claim. We received numerous public comments objecting to this potential solution. In the 2018 PFS final rule, we agreed with many of the commenters that additional approaches to reporting AUC consultation information on Medicare claims should be considered, and in the opinion of some commenters, reporting unique consultation identifiers (UCIs) would be a less burdensome and preferred approach. We had the opportunity to engage some stakeholders and we understand that some commenters from the previous rule continue to be in favor of a UCI. Practically examining the workflow of an order for an advanced diagnostic imaging service before and after implementation of the Medicare AUC program, we see that in general the process remains largely unchanged. Before and after the implementation of this program, an ordering professional could employ support staff to transmit an order for an advanced diagnostic imaging service from his or her office to an imaging facility, physician office, or hospital that furnishes advanced diagnostic imaging services. After implementation of this program, the ordering professionals, furnishing professionals and facilities must adapt this existing workflow to accommodate new information not previously required on orders for advanced diagnostic imaging services.
We considered leaving the policy unchanged, and we also considered writing new regulations requiring larger modifications to the form and manner by which AUC consultation information is communicated from the ordering professional to the furnishing professional or facility. However, we believe this final rule minimizes burden and maximizes efficiency by reporting through established coding methods, to include G-codes and modifiers, to report the required AUC information on Medicare claims.
We estimate that including AUC consultation information on the order to the furnishing professional or facility is estimated as the additional 5 minutes spent by a medical secretary (BLS #43-6013) at a mean hourly rate of $17.25 plus 100 percent fringe to transmit the order for the advanced diagnostic
While we did not finalize use of a UCI to report AUC consultation information, the following section remains important to understanding the impact of standardizing the UCI should we move forward with such additional modifications in the future.
We believe that in considering a distinct UCI we also considered updating the requirements of a qualified CDSM in § 414.94(g)(1)(vi)(B). This would incur additional costs for the developers of these mechanisms to accommodate formatting changes if instructed by CMS. We continue to believe that participation by CDSM developers in this program is voluntary, that any considerations of proposed changes to this policy maximize benefits and minimize burden to ordering professionals and furnishing professionals and facilities. Internally, CMS has explored the possibility of using a UCI to determine feasibility, and provide a detailed estimate of costs to develop, test, and implement an update in the form and manner of the UCI generated by the CDSM.
To estimate the costs to develop, test, and implement this update, we will provide a relevant case study. In 1998, the Year 2000 Information and Readiness Disclosure Act (Pub. L. 105-271, enacted October 19, 1998) was passed to ensure continuity of operations in the year 2000. At the time of passage, millions of information technology computer systems, software programs, and semiconductors were not capable of recognizing certain dates after December 31, 1999, and without modification would read dates in the year 2000 and thereafter as if those dates represented the year 1900 or thereafter, or would have failed to process those dates entirely. The federal government had budgeted $8,300,000,000 to continue processing dates in 2000 and beyond (Department of Commerce, 1999). Additional estimates to repair the date in a form and manner accommodating the year 2000 varied, but one estimate
The following is a summary of the comments we received on the proposed estimated impact of claims-based reporting.
After reviewing the comments, we are finalizing the proposed estimate of impact of claims based reporting. We note that before and after the implementation of this program, an ordering professional could employ support staff to transmit an order for an advanced diagnostic imaging service
We expect that an AUC consultation must take place for every applicable imaging service furnished in an applicable setting and paid for under an applicable payment system. In the CY 2017 PFS final rule (81 FR 80170), we codified the definition of applicable setting in § 414.94(b) to include a physician's office, a hospital outpatient department (including an emergency department), an ambulatory surgical center, and any other provider-led outpatient setting determined appropriate by the Secretary. In this final rule, we finalize as proposed adding IDTFs to the definition of applicable settings under this program. This was based on the following factors from 2016 CMS Statistics: (1) An IDTF is independent both of an attending or consulting physician's office and of a hospital; (2) diagnostic procedures when performed by an IDTF are paid under the PFS; (3) independent facilities have increased 5,120 percent from 4,828 in 1990 to 252,044 in 2015; (4) Of those facilities, 1,125 received total payments in excess of $100,000 in 2015; (5) there were 37,038 radiology non-institutional providers utilized by fee-for-service Medicare beneficiaries for all Part B non-institutional provider services in 2015, of which 14,341 received total payments in excess of $100,000 in 2015. Taken together, we believe this will result in a more even application of the Medicare AUC program.
To estimate this impact, we assume based on data derived from the CCW's 2014 Part B non-institutional claim line file, which includes services covered by the Part B benefit that were furnished during CY 2014, that approximately 40,000,000 advanced diagnostic imaging services are furnished annually, but questioned whether for the purposes of this estimate we should attribute equal weight for these services furnished by each of the following places: (1) A physician's office; (2) a hospital outpatient department; (3) an ambulatory surgical center; and (4) an IDTF. Therefore, we sought to determine the frequency of advanced diagnostic imaging services furnished by each setting.
For this estimation, we analyzed 2014 Medicare Part B claims data to weight the various applicable settings subject to this program. For this estimate, we analyzed a count of total services furnished for the following 7 Current Procedural Terminology (CPT) codes for advanced diagnostic imaging studies: 70450—computed tomography, head or brain, without contrast material; 74177—computed tomography, abdomen and pelvis, without contrast material; 70553—magnetic resonance (
In this sample, we found the following total services and percent of total services for each of the following settings: (1) Physician's office, 2,997,460 total services, 28.5 percent; (2) hospital outpatient department, 7,465,279 total services, 70.9 percent; (3) ambulatory surgical center, 1,062 total services, 0.01 percent; (4) IDTF, 58,900 total services, 0.6 percent. We also examined whether the total services furnished in 2015 for each setting increased more than 10 percent from 2014. We found the following total services and percent change from 2014 for each of the following settings: (1) Physician's office, 2,944,144 total services, 2 percent decrease; (2) hospital outpatient department, 7,854,997 total services, 5 percent increase; (3) ambulatory surgical center, 2,900 total services, 173 percent increase; (4) IDTF, 65,479 total services, 11 percent increase. Taken together, we believe these estimates that attribute 70 percent of all advanced diagnostic imaging services to outpatient, 28 percent to physician's office, and 1 percent each to ambulatory surgical centers and independent diagnostic testing facilities, respectively is generalizable to the total number of visits by Medicare beneficiaries to each of those applicable settings, respectively.
We do not expect that for the purposes of this program furnishing professionals and facilities will need to create new billing practices; however, we assume that the majority of furnishing professionals and facilities will work to alter billing practices through automation processes that accommodate AUC consultation information when furnishing advanced diagnostic imaging services to Medicare beneficiaries. Therefore, we believe a transfer of costs and benefits will be made from furnishing professionals and facilities to medical billing companies to create, test, and implement changes in billing practice for all affected furnishing professionals and facilities.
As mentioned earlier, the 2016 CMS Statistics identified 37,038 radiology non-institutional providers (Table II.8), and 5,470 ambulatory surgical centers (Table II.5) as of December 31, 2015. Because the classification of independent facilities includes both diagnostic radiology and diagnostic laboratory tests, we will assume that 50 percent of the 252,044 facilities existing in 2015 according to 2016 CMS Statistics (126,022 facilities) furnish advanced diagnostic imaging services. The American Hospital Association (AHA) Hospital Statistics published in 2018 by Health Forum, an affiliate of the AHA, identifies the total number of all U.S. registered hospitals to be 5,534. Taken together, we have identified an estimated 174,064 furnishing professionals (37,038 radiologists + 5,470 ASCs + 126,022 independent diagnostic testing facilities + 5,534 hospitals). We will assume for the purposes of this calculation that every identified furnishing professional and facility will choose to update their processes for the purposes of this program in the same way by purchasing an automated solution to reporting AUC consultation information.
The effective date of January 1, 2020 provides some but not extensive time to prepare to update billing processes to accept and report AUC consultation information. Requirements at § 414.94(k) include the following additional information that must be reported: (1) The qualified CDSM consulted by the ordering professional; (2) information indicating whether the service ordered would or would not
The Congressional Budget Office estimates that section 218 of the PAMA would save approximately $200,000,000 in benefit dollars over 10 years from FY 2014 through 2024, which could be the result of identification of outlier ordering professionals and also includes section 218(a) of the PAMA—a payment deduction for computed tomography equipment that is not up to a current technology standard. Because we have not yet proposed a mechanism or calculation for outlier ordering professional identification and prior authorization, we are unable to quantify the impact of prior authorization at this time.
The following is a summary of the comments we received on the proposed estimated impact on furnishing professionals and facilities.
After reviewing all comments, we are finalizing our proposed estimate without modification. However, we note that these estimates are based on multiple assumptions and as such may be an overestimate of burden.
We believe that the first 5 years of this program will be dedicated to implementation activities, from installation of the technology to training to operational and behavioral changes. Information on the benefits of adopting qualified CDSMs or automating billing practices specifically meeting the requirements in this final rule does not yet exist—and information on benefits overall is limited. Nonetheless, we believe there are benefits that can be obtained by ordering professionals, furnishing professionals and facilities, beneficiaries and technology infrastructure developers including qualified CDSM developers, EHR systems developers, and medical billing practices. We describe these estimated benefits in more detail in the following sections.
It has been suggested that one-third of imaging procedures are inappropriate, costing the United States between $3 billion and $10 billion annually
It seems reasonable from this and other studies
Although qualified CDSMs are not required to demonstrate that their tools provide measurable benefits, we believe that as a result of installation and use, some ordering professionals may find benefits to the patients they serve. For example, if a qualified CDSM creates a flag or alert to obsolete tests, then the patient will benefit from avoiding unnecessary testing. The same outcome would be likely if a qualified CDSM implemented algorithms that recognize advanced diagnostic imaging services that may produce inaccurate results because of medications being taken by the patient. In addition, if the CDSM provides standardized processes for advanced diagnostic imaging orders or clarification for confusing test names, then the patient benefits from a potential decrease in medical errors and less exposure. Finally, we believe it is reasonable to assume that some improvements in shared decision making could result from use of a qualified CDSM, because some CDSMs could provide cost information associated with advanced diagnostic imaging services and/or identify situations of repeated testing.
The following is a summary of the comments we received on the proposed estimated benefits that can be obtained by ordering professionals, furnishing professionals and facilities, beneficiaries and technology infrastructure developers including qualified CDSM developers, EHR systems developers, and medical billing practices.
In the Medicaid Promoting Interoperability Program, to keep electronic clinical quality measure (eCQM) specifications current and minimize complexity, we proposed to align the eCQMs available for Medicaid EPs in 2019 with those available for MIPS eligible clinicians for the CY 2019 performance period. We explained that we anticipated that this proposal would reduce burden for Medicaid EPs by aligning the requirements for multiple reporting programs, and that the system changes required for EPs to implement this change would not be significant, as many EPs are expected to report eCQMs to meet the quality performance category of MIPS and therefore should be prepared to report on those eCQMs for 2019. We explained that we expected that this proposal would have only a minimal impact on states, by requiring minor adjustments to state systems for 2019 to maintain current eCQM lists and specifications. State expenditures to make any systems changes required as a result of this proposal would be eligible for ninety percent enhanced Federal financial participation. After careful consideration of the comments received on this proposal, we are finalizing it without change. See discussion of comments in section III.E. of this final rule.
For 2019, we proposed that Medicaid EPs would report on any six eCQMs that are relevant to the EP's scope of practice, including at least one outcome measure, or if no applicable outcome measure is available or relevant, at least one high priority measure, regardless of whether they report via attestation or electronically. This policy would generally align with the MIPS data submission requirement for eligible clinicians using the eCQM collection type for the quality performance category, which is established in § 414.1335(a)(1). After careful consideration of the comments received on this proposal, we are finalizing it without change, and also explain that if no outcome or high priority measure is relevant to a Medicaid EP's scope of practice, he or she may report on any six eCQMs that are relevant. We also proposed that the eCQM reporting period for EPs in the Medicaid Promoting Interoperability Program would be a full CY in 2019 for EPs who have demonstrated meaningful use in a prior year, in order to align with the corresponding performance period for the quality performance category in MIPS. This proposal is also finalized without change, after careful consideration of comments received. (See discussion of comments in section III.E. of this final rule.) We continue to align Medicaid Promoting Interoperability Program requirements with requirements for other CMS quality programs, such as MIPS, to the extent practicable, to reduce the burden of reporting different data for separate programs.
In order to help states to make incentive payments to Medicaid EPs by December 31, 2021, consistent with section 1903(t)(4)(A)(iii) of the Act, we proposed to amend § 495.4 to provide that the EHR reporting period in 2021 for all EPs in the Medicaid Promoting Interoperability Program would be a minimum of any continuous 90-day period within CY 2021, provided that the end date for this period falls before October 31, 2021, to help ensure that the state can issue all Medicaid Promoting Interoperability Program payments on or before December 31, 2021. Similarly, we proposed to change the eCQM reporting period in 2021 for EPs in the Medicaid Promoting Interoperability Program to a minimum of any continuous 90-day period within CY 2021, provided that the end date for this period falls before October 31, 2021, to help ensure that the state can issue all Medicaid Promoting Interoperability Program payments on or before December 31, 2021.
We proposed to allow states the flexibility to set alternative, earlier final deadlines for EHR or eCQM reporting periods for Medicaid EPs in CY 2021, with prior approval from CMS, through their State Medicaid HIT Plans (SMHP). Providing states with the flexibility to set an alternative, earlier last possible date for the EHR or eCQM reporting period for Medicaid EPs in 2021 would make it easier for states to ensure that all payments are made by the December 31, 2021 deadline, especially for states whose prepayment process may take longer than the 61 days provided for by an October 31, 2021 deadline. We explained that we expect that this proposal would have only a minimal impact on states, by requiring minor adjustments to state systems to meet specifications for the proposed reporting periods, especially because we are also proposed to permit states to set a different end date for all EHR and eCQM reporting periods for Medicaid EPs in 2021. As previously noted, state expenditures for any systems changes required as a result of this proposal would be eligible for 90 percent enhanced Federal financial participation. After careful consideration of the comments received on this proposal, as discussed above in section III.E. of this final rule, we are finalizing it without change. However, in light of comments received from EPs, we are also considering whether to propose in future rulemaking that no state may set a reporting period deadline for CY 2021 that is earlier than June 30, 2021, or an attestation deadline for CY 2021 that is earlier than July 1, 2021.
Finally, we proposed changes to the EP Meaningful Use Objective 6, (Coordination of care through patient engagement) Measure 1 (View, Download, or Transmit) and Measure 2 (Secure Electronic Messaging), and to EP Meaningful Use Objective 8, Measure 2 (Syndromic surveillance reporting). We proposed to amend these measures in response to feedback about the burdens they create for EPs seeking to demonstrate meaningful use, and about how they may not be fully aligned with how states and public health agencies collect syndromic surveillance data. These proposed amendments were expected to reduce EP burden. Again, we expected that any changes these proposals might require to state systems would be minimal and that state expenditures to make any such changes would also be eligible for 90 percent enhanced federal financial participation. After careful consideration of the comments received on these proposals, as discussed in section III.E. of this final rule, we are finalizing them without change.
In section III.F.1.b. of this final rule, we summarize the proposed certain modifications to the quality measure set used to assess the quality of performance of ACOs participating in the Shared Savings Program. Specifically we proposed: (1) The addition of two Patient Experience of Care Survey measures, and (2) the removal of four claims-based outcome measures. After consideration of the comments received, we are finalizing these proposed modifications to the quality measure set for the Shared Savings Program in sections III.F. of this final rule.
The modifications to the Shared Savings Program quality measure set reduce the number of measures in the Shared Savings Program quality measure set from 31 to 23 measures, making the quality measure set more outcome oriented. This reduction in the number of measure is expected to reduce ACO reporting burden and
The physician self-referral law provisions are discussed in section III.G. of this final rule. We are finalizing regulatory updates to implement the provisions of section 50404 of the Bipartisan Budget Act of 2018 pertaining to the writing and signature requirements in certain compensation arrangement exceptions to the statute's referral and billing prohibitions. The regulatory language for the writing requirement reflects current policy, so we do not anticipate that it will have an impact. We expect that the update regarding temporary non-compliance with signature arrangements will reduce burden by giving parties additional time to obtain all required signatures.
In section III.I. of this final rule, we included our finalized policies for the Quality Payment Program. In this section of the final rule, we present the overall and incremental impacts to the number of expected QPs and associated APM incentive payments. In MIPS, we analyze the total impact and incremental impact of statutory changes to eligibility from the Bipartisan Budget Act of 2018, as well as final policies to expand MIPS eligibility by expanding the MIPS eligible clinician definition and adding a third criterion for the low-volume threshold and an opt-in policy option for any clinician that exceeds at least one, but not all, of the low-volume threshold criteria. Finally, we estimate the payment impacts by practice size based on various final policies to modify the MIPS final score, such as the new Promoting Interoperability performance category policies, for the performance threshold and additional performance threshold, and as required by the Bipartisan Budget Act of 2018, the impact of applying the MIPS payment adjustments to covered professional services (services for which payment is made under, or is based on, the PFS and that are furnished by an eligible clinician) rather than items and services covered under Part B.
The submission period for the first MIPS performance period ended in early 2018; however, the final data sets were not available in time to incorporate into the CY 2019 PFS proposed rule analysis (83 FR 36057). We stated in the proposed rule that if technically feasible, we intended to use data from the CY 2017 MIPS performance period for the final rule. In this analysis, we have updated our analyses from the proposed rule to consider data submitted for the 2017 MIPS performance period (which we refer to in this section as Quality Payment Program Year 1 data). In section VII.F.8.b. of this final rule, we summarize the high level findings of updating our model with Quality Payment Program Year 1 data.
From 2019 through 2024, through the Medicare Option, 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, for the applicable performance period, will 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. In addition, beginning in payment year 2021, in addition to the Medicare Option, eligible clinicians may become QPs through the All-Payer Combination Option. The All-Payer Combination Option will allow eligible clinicians to become QPs by meeting the QP thresholds through a pair of calculations that assess a combination of both Medicare Part B covered professional services furnished through Advanced APMs and services furnished through Other Payer Advanced APMs.
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 PFS 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, if they elect to report, would then be scored under MIPS and receive a MIPS payment adjustment, but will not receive the APM Incentive Payment. For the 2019 Medicare QP Performance Period, we define Partial QPs to be eligible clinicians in Advanced APMs who collectively have at least 40 percent, but less than 50 percent, of their payments for Part B covered professional services through an APM Entity, or collectively furnish Part B covered professional services to at least 20 percent, but less than 35 percent, of their Medicare beneficiaries through an 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, negative or neutral. If an eligible clinician does not meet either the QP or Partial QP standards, and does not meet any another exemption category, the eligible clinician would be subject to MIPS, would report to MIPS, and would receive the corresponding MIPS payment adjustment.
Beginning in payment year 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 receive positive, neutral, or negative MIPS payment adjustments to payment for their Part B PFS services in a payment year based on performance during a prior performance period. Although MACRA amendments established overall payment rate and procedure parameters until 2026 and beyond, this impact analysis covers only the third payment year (2021 MIPS payment year) of the Quality Payment Program in detail.
In section III.I.4.g.(4)(b) of this final rule, we summarized our finalized policy to add a third alternative to allow requests for QP determinations at the TIN level in instances where all clinicians who have reassigned billing rights under the TIN participate in a single APM Entity. This option will therefore be available to all TINs participating in Full TIN APMs, such as the Medicare Shared Savings Program. It will also be available to any other TIN for whom all clinicians who have reassigned billing rights to the TIN are participating in a single APM Entity. We also finalized that this third alternative will only be available to eligible clinicians who meet the Medicare threshold at the APM Entity level; it will not be available for eligible clinicians who meet the Medicare threshold individually.
In section III.I.4.g.(4)(c)(ii) of this final rule, we also discussed our finalized policy to extend the same weighting methodology to TIN level Medicare Threshold Scores in situations where a TIN is assessed under the Medicare Option as part of an APM Entity group, and receives a Medicare Threshold Score at the APM Entity group level. In this scenario, we believe that the Medicare portion of the TIN's All-Payer Combination Option Threshold Score should not be lower than the Medicare Threshold Score that they received by
These finalized policies affect the estimated number of QPs for the 2021 payment year. We estimate that approximately 8,100 eligible clinicians in 8 APM Entities representing approximately 225 TINs will become QPs due to these finalized policies representing TIN level QP determinations under the All-Payer Combination Option. Therefore, they will be excluded from MIPS, and qualify for the lump sum incentive payment based on 5 percent of their Part B allowable charges for covered professional services, which are estimated to be approximately $545 million in the 2019 performance year. We also estimated the corresponding increase of the APM incentive payment of 5 percent of Part B allowed charges for these QPs will be approximately $27 million for the 2021 payment year. However, we note that the majority, if not all, of the 8,100 eligible clinicians that would become QPs if these policies are finalized, had already attained QP status in the 2018 QP performance period. Therefore, the associated APM incentive payments for these 8,100 would not be additional impacts in comparison to previous performance years, only additional impacts in the absence of finalizing these proposed policies.
Overall, we estimated that between 165,000 and 220,000 eligible clinicians will become QPs, therefore be excluded from MIPS, and qualify for the lump sum incentive payment based on 5 percent of their Part B allowable charges for covered professional services in the preceding year, which are estimated to be between approximately $12,000 million and $16,000 million in total for the 2019 performance year. We estimated that the aggregate total of the APM incentive payment of 5 percent of Part B allowed charges for QPs will be between approximately $600 and $800 million for the 2021 payment year. The estimated number of QPs in this final rule is slightly higher than the estimates of 160,000 and 215,000 clinicians included in the proposed rule due to more updated information being available for the final rule. The proposed rule used the APM Participation Lists on the most recent MDM provider extract for the Predictive QP determination file for 2018, whereas this final rule uses the APM Participation Lists on the most recent MDM provider extract for the Second QP determination file for the 2018 performance period. This more updated information did not significantly change the estimated amount of total Part B allowed charges and the amount of total APM incentive payments.
We projected the number of eligible clinicians that will be QPs, and thus excluded from MIPS, using several sources of information. First, the projections are anchored in the most recently available public information on Advanced APMs. The projections reflect Advanced APMs that will be operating during the 2019 QP performance period, as well as Advanced APMs anticipated to be operational during the 2019 QP performance period. The projections also reflect an estimated number of eligible clinicians that would attain QP status through the All-Payer Combination Option. The following APMs are expected to be Advanced APMs in performance year 2019: Next Generation ACO Model, Comprehensive Primary Care Plus (CPC+) Model, Comprehensive ESRD Care (CEC) Model (Two-Sided Risk Arrangement), Vermont All-Payer ACO Model (Vermont Medicare ACO Initiative),
In the CY 2019 PFS proposed rule (83 FR 36058 through 36068), the RIA modeled MIPS eligibility and performance using data from the Physician Quality Reporting System (PQRS), the Value Modifier, and the Medicare/Medicaid EHR Incentive programs to account for the absence of MIPS performance data. We indicated, that if feasible, we would integrate performance data from the CY 2017 MIPS performance period (which we refer to in this section of the final rule as Quality Payment Program Year 1 data). The model in the 2019 PFS proposed rule had several assumptions to proxy MIPS performance and we noted the limitations of the model (83 FR 36067).
In this final rule, we integrated Quality Payment Program Year 1 data into our model estimates and we chose to summarize in this section important differences or findings that are needed for context when interpreting the RIA in this final rule. It should be noted that although we are using Quality Payment Program Year 1 data, the estimates described in this RIA reflect the impact of the finalized policies in this final rule and do not reflect actual CY 2017 MIPS performance period/2019 MIPS payment year results.
First, the Quality Payment Program Year 1 data had more complete group and individual participation and performance data. In the CY 2019 PFS proposed rule (83 FR 36053 through 36061), we estimated group reporting solely based on the submission of quality data as a group to 2016 PQRS. For this final rule, we were able to identify group reporting through submissions to quality, improvement activities or Promoting Interoperability performance categories. As a result, we observed higher group reporting than was previously estimated using PQRS performance data. This finding led to a 42 percent increase (from approximately 390,000 in the CY 2019 PFS proposed
Second, we observed an increase in participation among small practices than previously estimated in the CY 2019 PFS proposed rule. The number of clinicians in small practices (who we believe are estimated to be in MIPS year 3) estimated to submit data increased from 79.7 percent to 89.9 percent. We believe this is related to our policies for the 2017 MIPS performance period which was designed to encourage participation, engage clinicians and help them transition smoothly into MIPS. (See section VII.F.8.d.(3) for more details.)
Third, the Quality Payment Program Year 1 data allowed for the direct observation of performance for the MIPS performance categories. With the availability of actual advancing care information and improvement activities performance category data from the Quality Payment Program Year 1, we improved our estimates for the Promoting Interoperability and improvement activities performance category scores at the individual and group level for the 2019 MIPS performance period/2021 MIPS payment year. This led to more variation in performance at the individual and group level for these performance categories compared to the model in the 2019 PFS proposed rule and to the ability to accurately assess which clinicians are measured on Promoting Interoperability or are reweighted (see section III.I.3.h.(5) of this final rule for more details).
Finally, the Quality Payment Program Year 1 data improved our ability to estimate who is excluded from MIPS, such as newly enrolled clinicians. We found that the previous proxy for the CY 2019 PFS proposed rule overestimated the number of newly enrolled clinicians than the observed with the Quality Payment Program Year 1 data. As a result, fewer clinicians were excluded from MIPS compared to the CY 2019 PFS proposed rule. (See section VII.F.8.c.(2) of this final rule for more details.)
In summary, the estimates presented in the RIA of this final rule differ from the CY 2019 PFS proposed rule due to our ability to improve our estimates of eligibility and performance in MIPS. As a result of data source and methodology changes for the final policies of this final rule, we observe a slight decrease in final scores. For example, the mean and median final scores in the CY 2019 PFS proposed rule analysis were 73.41 and 82.41 respectively,
In section III.I.3 of this final rule, we finalized three sets of policy changes that would impact the number of MIPS eligible clinicians starting with CY 2019 MIPS performance period and the associated CY 2021 MIPS payment year. Two of the changes were finalized as proposed and affect the low-volume threshold. The third policy affects the definition of a MIPS eligible clinician and was finalized with modifications.
In section III.I.3.c.(2) of this final rule, we finalized as proposed changes to our policy to comply with the Bipartisan Budget Act of 2018. Specifically, we updated the low-volume threshold starting with the 2020 MIPS payment year to be based on covered professional services (services for which payment is made under, or is based on the PFS and that are furnished by an eligible clinician) rather than items and services covered under Part B, as provided in section 1848(q)(1)(B) as amended by section 51003(a)(1)(A)(i) of the Bipartisan Budget Act of 2018. This finalized policy may affect the previously finalized calculation for the low-volume threshold for certain clinicians because payment for items, such as Part B drugs, which were previously considered in the low-volume determination, are now excluded. In addition, section 51003(a)(1)(E) of the Bipartisan Budget Act of 2018 revised section 1848(q)(6)(E) to apply the MIPS payment adjustments to covered professional services rather than to items and services covered under Part B. This change is effective with the 2019 MIPS payment year. Its effect on the amount of payment adjustments under MIPS is included in this analysis.
Second, in section III.I.3.a. of this final rule, beginning with the 2021 MIPS payment year, we finalized with modification the expansion of the definition of MIPS eligible clinicians to include physical therapists, occupational therapists, speech-language pathologists, audiologists, clinical psychologists, and registered dietitians or nutrition professionals. This finalized list differs from the proposed list of physical therapists, occupational therapists, clinical social workers, and clinical psychologists (83 FR 36058). Specifically, we finalized the definition of MIPS eligible clinician, as identified by a unique billing TIN and NPI combination used to assess performance, as any of the following: 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), physical therapist, occupational therapist, speech-language pathologist, audiologist, clinical psychologist, and registered dietitian or nutrition professional; and a group that includes such clinicians.
Third, as discussed in sections III.I.3.c.(4) and III.I.3.c.(5) of this final rule, in addition to the amendments to comply with Bipartisan Budget Act of 2018, we finalized as proposed our definition of the low-volume threshold by adding a third criterion (for “covered
We discuss how the three finalized policy changes impact MIPS eligibility and payments, later in this section.
To estimate the number of MIPS eligible clinicians for the CY 2019 performance period in this final rule, our scoring model used the first determination period from CY 2020 MIPS payment year eligibility file as described in the CY 2018 Quality Payment Program Final Rule (82 FR 53587 through 53592). The first determination period from the CY 2020 MIPS payment year eligibility file was selected to maximize the overlap with the performance period data used in the model. In addition, the low-volume threshold for with the 2020 MIPS payment year was originally finalized in the CY 2018 Quality Payment Program final rule (82 FR 53587 through 53592) as using Part B items and services, but was later finalized in section III.I.3.c of this final rule to be based on covered professional services (services for which payment is made under, or is based on the PFS and that are furnished by an eligible clinician). Therefore, this data file provided the information to calculate a baseline as well as understand the incremental impact of basing the low-volume threshold on covered professional services rather than all items and services under Part B. We included 1.5 million clinicians (see Table 97) who had PFS claims from September 1, 2016 to August 31, 2017 and included a 30-day claim run-out.We excluded individual clinicians who were affected by the automatic extreme and uncontrollable policy finalized for the 2017 MIPS performance period/2019 MIPS payment year in section III.I.3.i.(2)(b)(ii)(B) of this final rule as we are unable to predict how these clinicians would perform in a year where there was no extreme and uncontrollable event.
Clinicians are ineligible for MIPS (and are excluded from MIPS payment adjustment) if they are newly enrolled to Medicare; are QPs; are partial QPs who elect to not participate in MIPS; are not one of the clinician types included in the definition for MIPS eligible clinician; or do not exceed the low-volume threshold. Therefore, we excluded these clinicians when calculating those clinicians eligible for MIPS.
For our baseline population, we restricted to clinicians who are 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). For the estimated MIPS eligible population for the CY 2021 MIPS payment year, we added in clinicians who are physical therapists, occupational therapists, speech-language pathologist, audiologist, clinical psychologist, and registered dietitian or nutrition professional.
As noted previously, we excluded QPs from our scoring model, since these clinicians are not eligible for MIPS. To determine which QPs should be excluded, we used the QP List for the first snapshot date of the 2018 QP performance period because these data were available by TIN and NPI and could be merged into our model. This data also included participants in APMs, such as the Medicare ACO Track 1+ Model, which were not available models in the 2017 QP performance period. From this data, we calculated the QP determinations as described in the Qualifying APM Participant definition at § 414.1305 for the 2019 QP performance period. We assumed that all partial QPs would participate in MIPS and included them in our scoring model and eligibility counts. The estimated number of QPs excluded from our model is lower than the projected number of QPs (165,000 to 220,000) for the 2019 QP performance period due to the expected growth in APM participation. Due to data limitations, we could not identify specific clinicians who may become QPs in the 2019 Medicare QP Performance Period; hence, our model may overestimate the fraction of clinicians and allowed charges for covered professional services that will remain subject to MIPS after the exclusions.
We also excluded newly enrolled Medicare clinicians from our model. To identify newly enrolled Medicare clinicians, we used the indicator that was used for the 2017 MIPS performance period/2019 MIPS payment year. The number of newly enrolled clinicians identified using this approach and data source was approximately one third the estimated number of newly enrolled clinicians estimated in the proposed rule which indicates we overestimated the number of newly enrolled clinicians in the CY 2019 PFS proposed rule impact analysis and that more clinicians are eligible for MIPS.
In section III.I.3.j.(4)(c) of this final rule, we finalized that beginning with the 2019 MIPS payment year the MIPS payment adjustment factors would not apply to certain model-specific payments for the duration of a section 1115A model's testing. Due to the aggregated data in our analysis, we were not able to incorporate this policy into our estimate.
In section III.I.3.j.(4)(d) of the final rule, we finalized the proposal to waive the payment consequences (positive, negative or neutral adjustments) of MIPS and to waive the associated MIPS reporting requirements adopted to implement the payment consequences for certain participating clinicians in the MAQI Demonstration subject to conditions outlined in the Demonstration, starting with the 2020 MIPS payment period. Removing eligible clinicians from MIPS may affect the payment adjustments for other MIPS eligible clinicians in each year the waiver is offered. At this time we are unable to identify specific clinicians that would be affected by this proposal (that is, removed from the MIPS payment adjustments), but estimate the first year number of clinicians to be less than 0.1 percent of all MIPS eligible clinicians. We plan to monitor the impact of the MAQI Demonstration on payments received by MIPS eligible
The low-volume threshold policy may be applied at the individual (that is, TIN/NPI) or group (that is, TIN or APM entity) levels based on how data are submitted. If no data are submitted, then the low-volume threshold is applied at the TIN/NPI level. A clinician or group that exceeds at least one but not all three low-volume threshold criteria may become MIPS eligible by electing to opt-in and subsequently submitting data to MIPS, thereby getting measured on performance and receiving a MIPS payment adjustment.
Table 97 compares the MIPS eligibility status and the associated PFS allowed charges from the CY 2019 PFS proposed rule (83 FR 36060) with the estimates of MIPS eligibility and the associated PFS allowed charges after using Quality Payment Program Year 1 data and applying the finalized policies for the CY 2019 MIPS performance period.
For the purposes of modeling, we made assumptions on group reporting to apply the low-volume threshold. One extreme and unlikely assumption is that no practices elect group reporting and the low-volume threshold would always be applied at the individual level. Although we believe a scenario in which only these clinicians would participate as individuals is unlikely, this assumption is important because it quantifies the minimum number of MIPS eligible clinicians. For final rule model, we estimate there are approximately 217,000 clinicians
Based on CY 2017 Quality Payment Program Year 1 data, we anticipate that group and APM Entities that submitted to MIPS as a group and APM Entity will continue to do so for the CY 2019 MIPS performance period. Therefore, if we revise our model's group reporting assumption such that all clinicians that were participating in ACOs in 2017 (including ACOs participating under the Shared Savings Program or Next Generation ACO Model) or who reported to the Quality Payment Program Year 1 as a group would continue to do so in MIPS, then the MIPS eligible clinician population would be approximately 770,000 clinicians if we only include the 218,000 required clinicians and the 553,000 clinicians who are only eligible because of group reporting. In Table 97, we identify these clinicians who do not meet the low-volume threshold individually but are anticipated to submit to MIPS as a group based on Quality Payment Program Year 1 data as having “group eligibility.” Updating the data source for identifying group reporting led to a 42 percent increase (from approximately 390,000 in the proposed rule to 553,000 in this final rule) in clinicians in the “group eligibility” category. We also observed a 33 percent increase in the PFS allowed charges in MIPS from $10,262 million in the proposed rule to $13,662 million in this final rule for the clinicians in the “group eligibility” category. The previous estimate presented in the proposed rule likely underestimated the number of clinicians using group reporting since previously group reporting could only be identified through the submission of quality data to PQRS. With the availability of CY 2017 Quality Payment Program Year 1 data, we can identify group reporting through the submission of improvement activities, Promoting Interoperability, or quality performance category data.To model the proposed opt-in policy, we assumed that 33 percent of the clinicians who exceed at least one low-volume threshold and submitted data to CY 2017 MIPS performance period would elect to opt-in to MIPS. We selected a random sample of 33 percent of clinicians without accounting for performance. We believe this assumption of 33 percent is reasonable because some clinicians may choose not to submit data due to performance, practice size, or resources or alternatively, some may submit data, but elect to be a voluntary reporter and not be subject to a MIPS payment adjustment based on their performance. Similar to the proposed rule (83 FR 36060), we applied a 33 percent opt-in assumption to estimate opt-in eligibility in this final rule. We sought comment on these assumptions in the proposed rule, including whether modeling eligibility only among clinicians or groups who submitted at least 6 quality measures to PQRS would be more appropriate. As we describe in more detail below, we also explored an alternate opt-in assumption where only high-performers would opt-in to MIPS. In the alternate model, we saw a difference in the maximum payment adjustment of approximately one-tenth of a percent. Given the minimal differences between the two alternatives, we elected to continue the assumption from the CY 2019 PFS proposed rule and present results with the 33 percent random opt-in for this impact analysis. This 33 percent participation assumption is identified in Table 97 as “Opt-In eligibility”. In the final rule analysis, we estimate an additional 28,000 clinicians would be eligible through this policy for a total MIPS eligible population of approximately 798,000. The leads to an associated $66.6 billion allowed PFS charges estimated to be included in the 2019 MIPS performance period.
We observed a decrease of approximately 14,000 clinicians compared to the proposed rule in the “opt-in eligibility” category after updating the data source and applying the finalized policies. This observed decrease in the number of clinicians that would elect to opt-in to MIPS is because there were fewer clinicians from which to randomly select for opt-in eligibility due to the increase in group reporting.
There are approximately 390,000 clinicians who are not MIPS eligible, but could be if their practice decides to participate. We describe this group as “Potentially MIPS eligible.” This is the unlikely scenario in which all group practices elect to submit data as a group and all clinicians that could elect to opt-into MIPS do elect to opt-in. This assumption is important because it quantifies the maximum number of MIPS eligible clinicians. When this unlikely scenario is modeled, we estimate that the MIPS eligible clinician population could be as high as 1.2 million clinicians. We observed a decrease of approximately 92,000 clinicians compared to the model in the proposed rule after updating the data source and applying the finalized policies. This observed decrease is due to the increase in group reporting.
Finally, there are some clinicians who would not be MIPS eligible either because they are below the low-volume threshold on all three criteria (approximately 78,000) or because they are excluded for other reasons (approximately 209,000). We observed a decrease of approximately 93,000 clinicians after updating the data source and applying the finalized policies. This observed decrease is due to much lower estimated number of newly enrolled clinicians but slightly higher number of QPs in the 2017 Quality Payment Program Year 1 data.
Since eligibility among some clinicians is contingent on submission to MIPS as a group or election to opt-in, we will not know the exact number of MIPS eligible clinicians until the submission period for the CY 2019 MIPS performance period is closed. For this impact analysis, we are using the estimated population of 797,990 MIPS eligible clinicians described above.
We received the following comments on our methodology:
For this final rule, we randomly selected 33 percent of clinicians that met at least one but not all the low-volume criteria and submitted to CY 2017 MIPS performance period. This led to an estimated 27,903 number of clinicians that will opt-in to MIPS. We also estimated the impact if we had assumed only those who expect to perform well would elect to opt-in. In the alternate model assumption where only high performers would opt-in to MIPS, we assumed 100 percent of clinicians with final scores above the additional performance threshold would opt-in and 50 percent of clinicians above the performance threshold but below the additional performance threshold would opt-in. We observed a decrease in the budget neutral pool from $310 million to $296 comparing the model with the 33 percent random opt-in to the model where only high-performers opt-in. We observed a minimal impact to the maximum payment adjustment compared to the model with 33 percent random opt-in (4.7 percent versus 4.6 percent). We refer readers to section III.I.3.c.(5) of this final rule for additional results on that analysis. Because we did not see much difference in results, we present the model with the 33 percent random opt-in this impact analysis.
After consideration of the public comments, we have updated our methodology to estimate the number of MIPS eligible clinicians for the 2019 MIPS performance period/2021 MIPS payment year to account for the Quality Payment Program Year 1 data and the policies finalized in this final rule.
We illustrate in Table 98
First, as shown in Table 98, the first row shows the effect of changing the application of the MIPS payment adjustments, as required by section 51003(a)(1)(E) of the Bipartisan Budget Act of 2018 to apply them to covered professional services (services for which payment is made under, or is based on, the Medicare PFS and are furnished by an eligible clinician) rather than to items and services covered under Part B. As shown, the baseline allowed charges for Part B is $79.4 billion, compared with $64.4 billion in covered professional services, which is a difference of almost $15 billion. Beginning in the 2019 MIPS payment year, payment adjustments will only be applied to the total paid amount for covered professional services.
In Table 98, under the first policy change, basing the low-volume threshold on covered professional services (services provided under the PFS rather than items and services covered under Part B) has minimal impact in terms of clinicians (less than half of one percent decrease).
When the second policy change, to expand the definition of MIPS eligible clinician types, was added to the first policy change, the total effect is small. The change in the potential MIPS eligible clinician population increased by less than 3 percent and the allowed charges in the PFS increased by 1.3 percent.
When the third policy change, which implements the opt-in policy, is added to the other two policies, the estimated number of MIPS eligible clinicians increases by 6.2 percent. The estimated increase in the allowed charges in the PFS is 3.5 percent.
In sections III.I.3.h., III.I.3.i. and III.I.3.j. of this final rule, we finalized several proposals which impact the measures and activities that impact the performance category scores, final score calculation, and the MIPS payment adjustment. We discuss these changes in more detail in section VII.F.8.d.(2) of this RIA as we describe our methodology to estimate MIPS payments for the 2021 MIPS payment year. We note that many of the MIPS policies from the CY 2018 Quality Payment Program final rule were only defined for the 2018 MIPS performance period and 2020 MIPS payment year (including the performance threshold, the additional performance threshold, the policy for redistributing the weights of the performance categories, and many scoring policies for the quality performance category) which precludes us from developing a baseline for the 2019 MIPS performance period and 2021 MIPS payment year if there was no new regulatory action. Therefore, our impact analysis looks at the total effect of the finalized MIPS policy changes on the MIPS final score and payment adjustment for CY 2019 MIPS performance period/CY 2021 MIPS payment year.
The payment impact for a MIPS eligible clinician is based on the clinician's final score, which is a value determined by their performance in the four MIPS performance categories: Quality, cost, improvement activities, and Promoting Interoperability. As described in the CY 2019 PFS proposed rule (83 FR 36061), the performance and participation data submitted for the 2017 MIPS performance period were not available to estimate the final score and the projected payment adjustments for MIPS eligible clinicians. This analysis has been updated with the Quality Payment Program Year 1 data and those results are presented in this final rule. We refer readers to CY 2019 PFS proposed rule (83 FR 36061 through 36066) for additional details on how we estimated the final scores and payment adjustments in the proposed rule.
The estimated payment impacts presented in this final rule reflect averages by practice size based on Medicare utilization. The payment impact for a MIPS eligible clinician could vary from the average and would depend on the combination 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; this program does not impact payment from 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 participation in MIPS for the CY 2019 Quality Payment Program for this final rule, we used CY 2017 Quality Payment Program Year 1 performance period data. Our scoring model includes the 797,990 estimated number of MIPS eligible clinicians as described in section VII.F.8.c of this RIA.
To estimate the impact of MIPS on eligible clinicians, we used the Quality Payment Program Year 1 submission data, including data submitted for the quality, improvement activities, and advancing care information performance categories, CAHPS for MIPS and CAHPS for ACOs, the total per capita cost measure, Medicare Spending Per Beneficiary (MSPB) measures and other data sets.
Starting in CY 2018 MIPS performance period, solo practitioner or a group of 10 or fewer eligible clinicians may elect to participate in MIPS as a virtual group (82 FR 53604). We had two virtual groups register for the 2018 performance period, of which one had all its participants participating in a MIPS APM for the 2018 performance period. While we anticipate an increase in the number of virtual groups for the 2019 MIPS performance period, we did not attempt to model virtual groups in this model as the participants in one virtual group who are in a MIPS APM would receive the MIPS APM score which left just one virtual group to measure.
We estimated the quality performance category score using measures submitted to MIPS for the 2017 performance period. For the quality measures, we started with the assigned measure achievement points assigned for the 2017 MIPS performance period. As finalized as proposed in III.I.3.i.(1)(b)(iii)(A) of this final rule, we applied a 3-point floor for measures that cannot be reliably scored against a baseline benchmark in the 2019 MIPS performance period. As described in section III.I.3.h.(2)(b)(iii) of this final rule, we finalized the proposal to remove many measures that were previously able to be reported in PQRS and in previous MIPS performance periods. For our estimates, we assumed that clinicians who reported Medicare Part B claims, eCQM, MIPS CQM and QCDR measures that are removed would find alternate measures; therefore, we assigned points to these measures and included them in our scoring model. For CY 2019, we maintained the policies for
As stated in section III.I.3.h.(2)(a)(iii)(A)(bb) of this final rule, we finalized the proposal to remove several Web Interface measures. For that collection type, which has a standard set of measures, we estimated performance on the measures that we propose to continue.
As finalized in sections III.I.3.i.(1)(b)(ix) and (x) of this final rule, we maintained the cap on bonus points for high-priority measures and end-to-end electronic bonus points at 10 percent of the denominator and, beginning with the 2019 MIPS performance period, discontinue high priority bonus points for CMS Web Interface Reporters. Because we are able to use MIPS performance data in our models, we assigned 1 point for each measure that was submitted with end-to-end electronic reporting with a cap of 10 percent of the total possible measure achievement points. To be consistent with our small practice bonus finalized policy in section III.I.3.i.(1)(b)(viii) of this final rule, we added 6 measure achievement points to the quality performance category score for small practices that had a quality performance category score greater than 0 points.
As finalized in the CY 2018 Quality Payment Program final rule (82 FR 53625 through 52626) and further discussed in III.I.3.h.(2)(a)(iii) of this final rule, we are allowing MIPS eligible clinicians and groups to submit data collected via multiple collection types within a performance category beginning with the 2019 performance period. The requirements for the performance categories remain the same regardless of the number of collection types used. We do not apply the validation process that is discussed in section III.I.3.i.(1)(b)(vii) of this final rule.
To estimate the impact of improvement for the quality performance category, we estimated a quality performance category percent score using 2019 MIPS data, 2015 and 2018 CAHPS for ACOs and MIPS data, and 2016 PQRS VM data. For MIPS eligible clinicians with an estimated quality performance category score less than or equal to a 30 percent score in the previous year, we compared 2019 performance to an assumed 2018 quality score of 30 percent for their improvement score as described in III.I.3.i.(1)(b)(xiii) of this final rule.
Due to data limitations, we are unable to model all the finalized policies in this rule. We are not able to incorporate the policy to reduce the denominator for the quality performance category score by 10 points for groups that registered for CAHPS for MIPS but were unable to report due to insufficient sample size as discussed in section III.I.3.i.(1)(b)(iii)(B) of this final rule. We also did not apply the finalized scoring policy for measures that are significantly impacted by clinical guideline or other changes discussed in section III.I.3.i.(1)(b)(vi) of this final rule.
Our model applied the MIPS APM scoring standards finalized in section III.I.3.h.(6) of this final rule to quality data from MIPS eligible clinicians that participated in the Shared Savings Program, and the Next Generation ACO Model in 2017.
In section III.I.3.h.(3)(b)(ii) of this final rule, we finalized the proposal to add 8 episode-based measures to the cost performance category beginning with the 2019 performance period. For the episode-based measures, we used the episode specifications proposed in the CY 2019 PFS proposed rule (83 FR 35902 through 35903) and claims data from June 2016 through May 2017. As discussed in section III.I.3.h.(3)(b)(ii) of this final rule, we made updates to the specifications for three episode measures. Due to timing constraints we were not able to incorporate the updated specifications into this impact analysis; however, we anticipate that the updates will only have a marginal effect on the cost measure scores.
We estimated the cost performance category score using the total per capita cost measure and Medicare Spending Per Beneficiary (MSPB) measures from the CY 2017 Quality Payment Period Year 1 data that was presented in the MIPS feedback reports. Cost measure scores were used only when the associated case size met or exceeded the previously finalized or newly finalized case minimum: 20 for the total per capita cost measure, 35 for MSPB, 10 for procedural episodes, and 20 for acute medical inpatient medical condition episodes. The cost measures are computed for both the TIN/NPI and the TIN. For clinicians participating as individuals, the TIN/NPI level score was used if available and if the minimum case size was met. For clinicians participating as groups, the TIN level score was used, if available, and if the minimum case size was met. For clinicians with no measures meeting the minimum case requirement, 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 category. The raw cost measure scores were mapped to scores on the scale of 1-10, using benchmarks based on all measures that met the case minimum during the relevant performance period. For the episode-based cost measures, separate benchmarks were developed for TIN/NPI level scores and TIN level scores. For each clinician, a cost performance category score was computed as the average of the measure scores available for the clinician.
As discussed in section III.I.3.i.(1)(d) of this final rule, we are implementing facility-based measurement for the 2019 MIPS performance period. In facility-based measurement, we determine the eligible clinician's MIPS score based on Hospital VBP Total Performance Score for eligible clinicians or groups who meet the eligibility criteria, which we designed to identify those who primarily furnish services within a hospital. Given that we are not requiring eligible clinicians to opt-in to facility-based measurement, it is possible that a MIPS eligible clinician or a group is automatically eligible for facility-based measurement but they participate in MIPS as an individual or a group. In these cases, we use the higher combined quality and cost performance category score from facility-based scoring compared to the combined quality and cost performance category score from MIPS submission based scoring.
Data was not available to attribute specific Hospital VBP Total Performance Score to MIPS eligible clinicians, hence we made the following assumptions. For MIPS eligible clinicians and groups who are eligible for facility-based measurement and who submitted quality data to the Quality Payment Program for the 2017 MIPS performance period, we did not estimate a facility-based score. We instead calculated a MIPS quality and cost score based on the available quality measures and cost data. Some clinicians who submitted Quality Payment Program quality data may receive a higher combined quality and cost score through facility-based measurement, but we are unable to identify those clinicians due to data limitations and therefore believe the score based on
For MIPS eligible clinicians that did not submit data to the Quality Payment Program for the 2017 MIPS performance period and were eligible for facility-based measurement, we estimated a facility-based score by taking the median MIPS quality and cost performance score. We believe it is important to develop an estimate for this cohort because we would have otherwise assigned this group a quality performance category percent score of zero percent which we believe would underestimate their MIPS final score. Given the data limitations in assigning a specific hospital score to a clinician, we selected the median MIPS quality and cost performance scores as that represents the quality and cost performance category scores that a clinician working in a hospital with median performance would receive.
As discussed in section III.I.3.h.(5)(d)(ii) of this final rule, we finalized the proposal to modify the measures and scoring for the Promoting Interoperability performance category score. We simplified scoring by eliminating the concept of base and performance scores and focusing on a smaller set of measures which are scored on performance. We estimated Promoting Interoperability performance category scores using the advancing care information performance category data from the CY 2017 Quality Payment Period Year 1 data. The Promoting Interoperability performance category scores were based on the individual level for individual submissions and on the group level for clinicians that were part of a group submission or part of an APM entity.
For the e-Prescribing objective, we only estimated the e-Prescribing measure and did not assume any bonus points for the Query of Prescription Drug Monitoring Program (PDMP) or the Verify Opioid Treatment Agreement measures. To estimate the e-Prescribing measure, we used the reported numerator and denominator values for the e-Prescribing measure for the advancing care information performance category, unless a measure exclusion applied.
For the Health Information Exchange objective, we used the required measures in the Health Information Exchange objective from the advancing care information performance category to proxy performance for the two finalized measures in the Promoting Interoperability objective. We used the Send Summary of Care measure and the Health Information Exchange transition measure for the Support Electronic Referral Loops by Sending Health Information measure. For MIPS eligible clinicians that reported data using 2015 CEHRT, we used the Request/Accept Summary of Care measure for the Support Electronic Referral Loops by Receiving and Incorporating Health Information. If this information was not available, then we used just the Send Summary of Care measure. If there was an exclusion for the Send Summary of Care measure or the Health Information Exchange transition measure, then for purpose of this model, we reweighted the measure to the Patient Electronic Access objective.
For the Provider to Patient Exchange objective, we used the Provide Patient Access measure to estimate performance for the finalized Provide Patients Electronic Access to Their Health Information measure.
For the Public Health and Clinical Data Exchange objective, we estimated the score by using the reported responses for the following advancing care information measures: Immunization Registry Reporting, Syndromic Surveillance Reporting, Electronic Case Reporting, Public Health Registry Reporting, Clinical Data Registry Reporting and Specialized Registry Reporting.
To calculate the Promoting Interoperability performance category, we summed the performance category measure scores and divided the total sum by the total number of possible points (100), as described in section III.I.3.i.(1)(d) of this final rule. As discussed in section III.I.3.i.(1)(d) of this final rule, a TIN/NPI must report on all required measures in the Promoting Interoperability performance category and complete all actions included in the Security Risk Analysis measure during the year to receive a non-zero performance category score. For APM Entities, we aggregated the scores of the participants consistent with the requirements for the 2017 MIPS performance period.
For eligible clinicians who did not submit a required Promoting Interoperability measure and did not complete all actions included in the Security Risk Analysis measure, we evaluated whether the MIPS eligible clinician could have their Promoting Interoperability performance category reweighted and applied the reweighting policies described in section III.I.3.h.(5)(d) of this final rule. For the Registry Reporting measures, which did not have an exclusion defined for the 2017 MIPS performance period, we assumed that failure to submit data or submissions with all “No” answers implied a request for exclusion. A group was only reweighted for the Promoting Interoperability performance category if all the TIN/NPIs were eligible for reweighting, thereby reweighting only applying to 24 percent of MIPS eligible clinicians as opposed to 62 percent of MIPS eligible clinicians scores in the CY 2019 PFS proposed rule (83 FR 36063) in which Promoting Interoperability was always assessed at the individual level.
As finalized in the CY 2017 (81 FR 77069 through 77070) and CY 2018 (82 FR 53625 through 52626) Quality Payment Program final rules, the Promoting Interoperability performance category weight is set equal to 0 percent, and the weight is redistributed to the quality or improvement activities performance category for non-patient facing MIPS eligible clinicians, hospital-based MIPS eligible clinicians, ASC-based MIPS eligible clinicians, or those who request and are approved for a significant hardship or other type of exception, including a significant hardship exception for small practices, or clinicians who are granted an exception based on decertified EHR technology (82 FR 53780 through 53786). We also finalized in section III.I.3.h.(5)(h) of this final rule to continue automatic reweighting for NPs, PAs, CNSs and CRNAs and to add an automatic reweighting policy for physical therapists, occupational therapist, speech-language pathologists, audiologists, clinical psychologists, and registered dietitians or nutrition professionals, which we have incorporated into our model. We used the non-patient facing and hospital-based indicators and specialty and small practice indicators as calculated in the initial MIPS eligibility run for the 2017 MIPS performance period (81 FR 77069 through 77070). For significant hardship exceptions, we used the approved significant hardship file for the 2017 MIPS performance period.
If a TIN/NPI did not report on all required measures and did not qualify for reweighting for a required measure, then their Promoting Interoperability performance category score was set to zero percent.
We modeled the improvement activities performance category score based on CY 2017 Quality Payment Period Year 1 data and APMs participation in the 2017 MIPS performance period. We did not make
Clinicians and groups not participating in a MIPS APM were assigned their CY 2017 Quality Payment Period Year 1 improvement activities performance category score.
In sections III.I.3.i.(2)(a)(ii) of this final rule, we finalized the proposed policy to continue the complex patient bonus. 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 the 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 2016 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 percent of dual eligible patients multiplied by 5, with a 5-point cap.
As finalized in sections III.I.3.h.(2)(a)(ii), III.I.3.h.(3)(a), III.I.3.h.(4)(a), III.I.3.h.(5)(d)(i) and summarized in section III.I.3.i.(2)(b) of this final rule, 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, multiplying the sum by 100 points, and adding the complex patient bonus. After adding any applicable bonus for complex patients, we reset any final scores that exceeded 100 points equal to 100 points. For MIPS eligible clinicians who were assigned a weight of zero percent for the Promoting Interoperability due to a significant hardship or other type of exception, the weight for the Promoting Interoperability performance category was redistributed to the quality performance category. For MIPS eligible clinicians who did not have a cost performance category score, the weight for the cost performance category was redistributed to the quality performance category. In our scoring model, we did not address scenarios where a zero percent weight would be assigned to the quality performance category or the improvement activities performance category.
As described in the CY 2018 Quality Payment Program final rule (82 FR 53785 through 53787), we applied a hierarchy to determine which final score should be used for the payment adjustment for each MIPS eligible clinician when more than one final score is available (for example if a clinician qualifies for a score for an APM entity and a group score, we select the APM entity score).
We then calculated the parameters of an exchange function in accordance with the statutory requirements related to the linear sliding scale, budget neutrality, minimum and maximum adjustment percentages and additional payment adjustment for exceptional performance (as finalized under § 414.1405), using a performance threshold of 30 points and the additional performance threshold of 75 points (as finalized in sections III.I.3.j.(2) and III.I.3.j.(3) of this final rule). We used these resulting parameters to estimate the positive or negative MIPS payment adjustment based on the estimated final score and the PFS paid amount. We considered other performance thresholds which are discussed in section VII.G. of this RIA.
Using the assumptions provided above, our model estimates that $310 million would be redistributed through budget neutrality and that the maximum positive payment adjustments are 4.7 percent after considering the MIPS payment adjustment and the additional MIPS payment adjustment for exceptional performance. The observed decrease in the funds available for redistribution and the maximum positive payment adjustment from the proposed rule to the final rule is due to the change in the data sources used to estimate final scores for MIPS eligible clinicians and the decrease in the additional performance threshold.
The use of 2017 Quality Payment Program Year 1 data to estimate the impact of the 2019 Quality Payment Program Year 3 finalized policies led to lower average final scores compared to the proposed rule. The main contributors to the lower estimated final scores were the changes in the estimated quality and Promoting Interoperability performance categories scores. The average quality scores were lower because some of the group reporters did not have quality data. As described in section VII.F.8.c.(2) of this final rule, we previously identified group reporters based on the submission of quality data submitted to PQRS; therefore, all group reporters submitted quality data and had a quality score. As a result of the 2017 Quality Payment Program Year 1 data, we can identify group reporters through submissions for the improvement activities or the Promoting Interoperability performance category who may not have submitted quality data. Therefore, these new groups in the estimated MIPS population received a zero (or close to zero) quality performance category score for not submitting quality data.
Table 99 shows the impact of the payments by practice size and whether clinicians are expected to submit data to MIPS.
The following is a summary of the public comments received regarding the estimated impact on payments for MIPS eligible clinicians:
After consideration of public comments, we have updated our analyses to incorporate the Quality Payment Program Year 1 data and the final policies.
In section III.I.3.h.(5)(c) of this final rule, we discussed the requirement to use EHR technology certified to the 2015 Edition beginning with the 2019 MIPS performance period for the Promoting Interoperability performance category. As discussed in section V.B.3 of this final rule, we assumed a slight decrease in overall information collection burden costs for the Promoting Interoperability performance category related to having fewer measures to submit.
With respect to any costs unrelated to data submission, although this final rule would require some investment in systems updates, our policy prior to this regulation as reflected in § 414.1305, is that 2015 Edition CEHRT will be required beginning with the 2019 MIPS
The following is a summary of the public comments received regarding these assumptions:
After consideration of public comments, we are not making any modifications on our potential cost for compliance with Promoting Interoperability performance category.
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 previously finalized 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.
We believe that because we finalized an opt-in policy (as described in section II.C.2.c of this final rule), we would add approximately 28,000 additional clinicians to the MIPS eligible clinicians. In section V.B.4 of this final rule, we assumed that those who have elected to opt-in have already been voluntary reporters in MIPS and would not have additional compliance costs as a result of this regulation. Thus, we believe the overall potential cost of compliance would not increase because of this final rule.
Further, we anticipate that the vast majority of clinicians submitting improvement activities data to comply with existing MIPS policies could continue to submit the same activities under the policies established in this final rule. Previously finalized improvement activities continue to apply for the current and future years unless otherwise modified per rule-making (82 FR 54175). We refer readers to Table H in the Appendix of the CY 2017 Quality Payment Program final rule (81 FR 77177 through 77199) and Tables F and G in the Appendix of the CY 2018 Quality Payment Program final rule (82 FR 54175 through 54229) for our previously finalized 112 improvement activities established in the Improvement Activities Inventory. In section III.I.3.h.(4)(d)(ii) of this final rule, we finalized 6 new improvement activities, 5 modifications, and 1 removal of an existing activity.
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 final rule. We requested comments that provide additional information that would enable us to quantify the costs, costs savings, and benefits associated with implementation of improvement activities in the inventory, but did not receive comments with information that would enable us to quantify the costs, costs savings, and benefits associated with the implementation and compliance with the requirements of the improvement activities performance category: In section III.I.3.h.(4)(e) of this final rule, we discuss how eligible clinicians can participate in the CMS study on burdens associated with reporting quality measures for each MIPS performance period. Eligible clinicians who are interested in participating can sign up and an adequate sample size is then selected by CMS from these potential participants. In the CY 2018 Quality Payment Program final rule, the sample size for the CY 2018 performance period was set at a minimum of 102 MIPS eligible clinicians (81 FR 77196). Each study participant is required to complete a survey prior to submitting MIPS data and another survey after submitting MIPS data. In section III.I.3.h.(4)(e) of this final rule, for the CY 2019 performance period, we finalized the increase to the sample size to a minimum of 200 MIPS eligible clinicians.
However, we made the focus group a requirement only for a selected subset of the study participants, using purposive sampling and random sampling methods, beginning with the CY 2019 performance period and future years. Completing each survey is estimated to require approximately 15 minutes; therefore, the annual hourly burden per participant is approximately 30 minutes. The annual hourly burden associated with the increase in sample size by 98 clinicians (from 102 clinicians to 200) is estimated to be 49 hours (98 clinicians × 0.5 hours). Using the hourly rate for physicians in section V.A of this final rule, the total estimated annual cost burden is estimated to be $10,116 ($206.44/hour × 49 hours). While the sample size of the study is increasing, we did not make a change to the sample size of MIPS eligible clinicians participating in the focus group, so no burden is estimated for participating in that activity. We did
We note several limitations to our estimates of MIPS eligible clinicians' eligibility and participation, negative MIPS payment adjustments, and positive payment adjustments for the 2021 MIPS payment year. We based our analyses on the data prepared to support the 2018 performance period initial determination of clinician and special status eligibility (available via the NPI lookup on
In our MIPS eligible clinician assumptions, we assumed that 33 percent of the opt-in eligible clinicians that participated in the CY 2017 Quality Payment Program Year 1 would elect to opt-in to the MIPS program. It is difficult to predict whether clinicians will elect to opt-in to participate in MIPS with the finalized policy.
There are additional limitations to our estimates: (1) We only estimated the potential impact of facility-based scoring for MIPS eligible clinicians that are eligible for facility-based measurement and would have a quality performance category score of zero from failure to submit quality data; (2) because we used historic data, we assumed participation in the three performance categories in MIPS Year 1 would be similar to MIPS Year 3 performance; and (3) 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 Table 99. Due to the limitations described, there is considerable uncertainty around our estimates that is difficult to quantify in detail.
This final rule includes certain provisions originally proposed for the Medicare Shared Savings Program (Shared Savings Program) in a proposed rule titled “Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations—Pathways to Success” (hereinafter referred to as the “August 2018 proposed rule”) that appeared in the
The most consequential of the changes to the Medicare Shared Savings Program being finalized in this final rule is the option for existing ACOs whose agreement periods expire on December 31, 2018, to elect an extension to their current agreement period for a fourth performance year, defined as the period from January 1, 2019, through June 30, 2019. Absent the voluntary 6-month extension as finalized in this rule, approximately 203 ACOs would be required to leave the program at least temporarily until the availability of an opportunity to enter a new agreement period for program participation. We estimate that up to 200 ACOs would elect the extension for the first 6 months of 2019, and therefore, would continue to improve care coordination and efficiency, and have the opportunity to receive shared savings for such period estimated to total approximately $170 million. As noted in the August 2018 proposed rule (83 FR 41922), we assumed that ACOs dropping out of the program may continue to produce residual savings in certain years following their exit from the program because of efficient practices put in place that may continue even after participation in the program ends. Therefore, while we estimate that ACOs electing the extension would produce additional savings on claims exceeding the cost of the anticipated $170 million in shared savings payments for the extension period, we note that lesser residual claims savings would also be expected for the baseline where such ACOs are not allowed to extend their participation in the program in the first 6 months of 2019 and therefore would not earn shared savings payments for that period. However, when considering the residual difference in savings on claims attributable to the 6-month extension period over the 12 months following the end of the extension we estimate that the $170 million in shared savings payments for the extension period would be fully offset by the effect of the extension on preserving a higher savings trajectory than the up to 200 ACOs that are expected to elect the extension would have exhibited absent the extension.
Lastly, we note that the modifications to the Shared Savings Program finalized in this rule that rely on the authority of section 1899(i)(3) of the Act, including most notably the methodology for determining the financial performance for the 6-month performance year from January 1, 2019, through June 30, 2019, for ACOs that voluntarily elect the extension, based on the entire 12-month CY 2019 and pro-rating the amount of any shared savings or shared losses to reflect the ACO's participation during a 6-month period, comply with requirements of section 1899(i)(3)(B). The considerations we described in the August 2018 proposed rule (83 FR 41851) (as well as those considerations discussed in section V.B.1. of this final rule) were relevant in making this determination. Specifically, we do not believe that the methodology for determining the financial performance of ACOs in a 6-month performance year from January 1, 2019, through June 30, 2019, would result in an increase in spending beyond the expenditures that would otherwise occur under the statutory payment methodology prescribed in section 1899(d) of the Act.
Finalizing the voluntary 6-month extension for ACOs whose agreement periods expire on December 31, 2018, supports continued participation by these ACOs, and therefore also allows
The anticipated forthcoming final rule will provide a detailed estimate of the impact of all other changes that may be finalized from the August 2018 proposed rule.
This final rule contains a range of policies, including some provisions related to specific statutory provisions. The preceding preamble provides descriptions of the statutory provisions that are addressed, identifies those policies when discretion has been exercised, presents rationale for our proposed policies and, where relevant, alternatives that were considered. For purposes of the payment impact on PFS services of the policies contained in this final rule, we presented the estimated impact on total allowed charges by specialty. The alternatives we considered, as discussed in the preceding preamble sections, would result in different payment rates, and therefore, result in different estimates than those shown in Table 94 (CY 2019 PFS Estimated Impact on Total Allowed Charges by Specialty).
For the CY 2019 PFS proposed rule, we considered a number of other options for simplifying coding and payment for E/M services to align with the proposed reduction in documentation requirements and better account for the resources associated with inherent complexity, visit complexity, and visits furnished on the same day as a 0-day global procedure. For example, as we noted in the proposed rule, we considered establishing single payment rates for new and established patients for combined E/M visit levels 2 through 4, as opposed to combined E/M visit levels 2 through 5, as we proposed. We considered the potential impacts of making this change in isolation.
Table 100 shows the specialties that would experience the greatest increase or decrease by establishing single payment rates for E/M visit levels 2 through 4, while maintaining the value of the level 1 and the level 5 E/M visits. We note that this alternative is similar to the policy we are finalizing for CY 2021. However, we are also finalizing the inherent visit complexity add-on codes that will likely result in mitigating some of the more significant estimated specialty-level impacts of establishing a single rate for the level 2-4 visits.
While considering whether to finalize a single payment rate for new and established office/outpatient E/M visit levels 2-5, we explored a number of alternative scenarios based on commenters' varied responses to aspects of our proposal. For example, we considered the potential impacts on finalizing all elements of the proposal except for the MPPR and the single PE/hr value across the office/outpatient E/M code set.
We also explored an alternative of finalizing all elements of the proposal except for separate coding for podiatric E/M visits and the application of a single PE/hr across the office/outpatient E/M codes.
We considered alternatives that included finalizing all elements of the proposal, except for the PE/hr change and separate coding for podiatric E/M visits and establishing a single payment rate for office/outpatient new and established E/M visit levels 2 through 4, rather than a single payment rate for office/outpatient E/M levels 2 through 5 as proposed. Table 103 illustrates the specialty level impacts of this alternative.
In this scenario, specialties that furnish a large volume of standalone office/outpatient E/M visits in conjunction with minor procedures see decreases in overall impacts, while specialties who tend to only bill E/M office/outpatient visits see minor increases and in many instances, the application of the MPPR adjustment is
We also modeled the specialty level impacts associated with finalizing all elements of the proposal with the exception of the PE/hr adjustment and the MPPR, but establishing a single payment rate for office/outpatient new and established E/M visit levels 2-4, rather than a single payment rate for office/outpatient E/M levels 2-5 as proposed. Table 104 illustrates the specialty level impacts for this alternative.
We considered several alternatives to our final policies on documentation of E/M office/outpatient visits. Under all of these alternatives, we would finalize the documentation proposals that are not associated with coding and payment changes (the documentation proposals for home visits and avoiding redundant data recording that we are finalizing for January 1, 2019 as proposed).
Regarding the rest of the documentation policies, one alternative we considered was to maintain all five current E/M office/outpatient visit levels and eliminate additional documentation requirements. Under this option, there would be no minimum documentation standard because payment rates for multiple code levels would not be combined, but we could still have allowed choice in documentation methodology (current framework, MDM or time). Overall payments would likely change due to increased ability to use different key components to reach different code levels relative to the status quo. There would be no new add-on codes for primary care, other non-procedural specialty care or prolonged services, since the current code set would continue to differentiate levels of complexity. We estimate that this alternative would have reduced the documentation burden for office/outpatient visits by approximately 5 percent or 0.32 minutes per impacted visit. However, this alternative could result in significant and unpredictable redistributive effects as there would be a financial incentive to code to the highest possible visit level. Given that possibility, we chose not to finalize this alternative.
Another alternative was our proposed policies, which in the proposed rule we estimated would have reduced administrative burden by approximately 1.6 minutes per impacted visit. A large part of this time savings was attributed to the associated application of the minimum level 2 visit documentation standard to most visits (levels 2 through 5). We did not finalize this proposal because we were persuaded by public comments (detailed elsewhere in this final rule), indicating that Medicare should continue to recognize distinctions in visit complexity among the current level 2 through 5 visits.
We considered not finalizing our proposal in the CY 2019 PFS proposed rule to recognize a discrete set of services that are defined by and inherently involve the use of communication technology. If we had not finalized making separate coding and payment for HCPCS codes G2010 ((Remote evaluation of recorded video and/or images submitted by an established patient (
For the purposes of estimating potential alternatives to the proposals in the CY 2019 PFS proposed rule for the AUC program, we considered the alternative scenarios below.
We considered an alternative scenario that would result in ordering professionals or auxiliary staff consulting more than one qualified CDSM prior to ordering advanced diagnostic imaging. In this scenario, we assumed a goal of decreasing the frequency that a “not applicable” consultation result would be reported on Medicare claims. One outcome of reducing “not applicable” responses is the potential to improve the quality and quantity of claims-based data available for calculating outlier ordering professionals. In future rulemaking the agency will establish the methodology to identifying outlier ordering professionals. Reducing “not applicable” responses will increase responses for adherence or non-adherence thereby increasing the total number of responses that can be used to calculate outlier ordering professionals. Additionally, according to the Medicare Imaging Demonstration Evaluation Report,
In this assumption, the ordering professional or auxiliary personnel would consult their primary, qualified CDSM to find that such AUC were not available. For example, a consultation using CDSM 1 for a patient with unspecified abdominal pain results in no specified applicable AUC being available, and therefore, provides a “not applicable” result. In this clinical scenario, we know that specified applicable AUC are available (
Based on these assumptions, we identified examples of the advanced diagnostic imaging services that are outside the priority clinical areas yet have AUC available for a specific clinical scenario in a qualified, free CDSM. We focused our analysis on abdominal pain (any locations and flank pain). In addition, we identified the top five advanced diagnostic imaging services from data derived from the CCW's 2014 Part B non-institutional claim line file, which includes services covered by the Part B benefit that were furnished during calendar year 2014. These data are available at
We estimated the burden of consulting a second, free CDSM to reduce the frequency of “not applicable” responses, which we did not propose. We did this by calculating the number of advanced diagnostic imaging services for unspecified abdominal pain based on 2014 claims data (Computed tomography of abdomen & pelvis with contrast—CPT 74177—299,644 services; Computed tomography of abdomen & pelvis with and without contrast—CPT 74176—233,088 services; Computed tomography of abdomen and pelvis; without contrast material in one or both body regions, followed by contrast material(s) and further sections in one or both body regions—CPT 74178—36,992 services; Diagnostic nuclear medicine procedures on the gastrointestinal system with pharmacologic intervention—CPT 78227—20,997 services; Diagnostic nuclear medicine procedures on the gastrointestinal system—CPT 78226-10,713 services). According to the Medicare Imaging Demonstration Evaluation Report,
If we assume that 50 percent of these 601,434 total services required a second consultation because the specified applicable AUC were available in CDSM 1 then this estimate would be the time and effort for a 2-minute repeat consultation with another qualified CDSM available free of charge for 300,717 services annually (601,434 services × 50 percent). If 90 percent of those consultations (300,717 services × 90 percent × 0.033 hr/service) for 8,931.285 total hours were performed by a medical assistant (occupation code 31-9092) at a rate of $32.30/hour for a total of $288,480.50 and 10 percent of consultations (300,717 services × 10 percent × 0.033 hr/service) for 992.376 total hours were performed by the ordering professional at a rate of $200.54/hour for a total of $199,011.08 then annually the burden estimate would be 9,923.661 total hours (8,931.285 hours + 992.376 hours) and $487,491.58 ($288,480.50 + $199,011.08) to perform the second consultations. This analysis was limited to abdominal pain because that is one example of a clinical scenario that falls outside of the priority clinical areas. In the proposed rule we did not propose tighter requirements on the frequency to which ordering professionals or applicable staff would be required to consult at this time this was due to the agency's efforts to minimize burden whereas a second consultation would result in added time and cost to the ordering professional.
To illustrate the consideration that a self-attestation of a significant hardship exception is a less burdensome approach, we compared this to the alternative consideration of requiring a significant hardship exception application process to review and approve applicants in near real-time. We recognize that there are some benefits to a significant hardship exception application that could not be directly quantified. For instance, some ordering professionals may gain confidence knowing that they have documentation confirming that a significant hardship exception application was submitted and/or received by CMS. Those same ordering professionals and others may appreciate a process that includes receipt of a determination from CMS as to the acceptance of their application for significant hardship exception. Finally some furnishing professionals and facilities that provide advanced diagnostic imaging services as a result of orders placed by ordering professionals could have reassurance knowing that such ordering professionals have a significant hardship exception granted by CMS and confirmed for 1 year.
As a basis for comparison of the significant hardship exception application to self-attestation, we estimate that such an application would be similar to the existing application (CMS-10621, OCN 0938-1314) to request a reweighting to zero for the advancing care information performance category (renamed the promoting interoperability performance category) due to significant hardship. This is a short online form that requires identifying which type of hardship applies, and a description of how the circumstances impair the ability to submit advancing care information data, as well as some proof of circumstances. The estimate for the $44.59 mean hourly wage and 100-percent fringe benefits of a computer system analyst (BLS #15-1121) to submit this application is 0.5 hours. Given that we would expect 6,699 AUC hardship applications per year, the annual total burden hours are estimated to be 3349.50 hours (6,699 respondents × 0.5 burden hours per respondent). The estimated total annual burden is $298,708.41 (3349.50 hours × $89.18 per hour). Based in part on the cost and burden estimates, we did not propose the use of a significant hardship exception application.
For purposes of the payment impact on the Quality Payment Program, we view the performance threshold and the additional performance threshold, as the critical factors affecting the distribution of payment adjustments. We ran two separate models with performance thresholds of 25 and 35 respectively (as an alternative to the finalized performance threshold of 30) to estimate the impact of a moderate and aggressive increase in the performance threshold. A lower performance threshold would be a more gradual transition and could potentially allow more clinicians to meet or exceed the performance threshold. The lower performance threshold would lower the amount of budget neutral dollars to redistribute and increase the number of clinicians with a positive payment adjustment but the scaling factor would be lower. In contrast, a more aggressive increase would likely lead to higher positive payment adjustments for clinicians that exceed the performance threshold because the budget neutral pool would be redistributed among fewer clinicians. We ran each of these models using the finalized additional performance threshold of 75. In the model with a performance threshold of 25, we estimate that $271 million would be redistributed through budget neutrality. There would be a maximum payment adjustment of 4.5 percent after considering the MIPS payment adjustment and the additional MIPS payment adjustment for exceptional performance. In addition, 7.2 percent of MIPS eligible clinicians would receive a negative payment adjustment among those that submit data. In the model with a performance threshold of 35, we estimate that $349 million would be redistributed through budget neutrality, and that there would be a maximum payment adjustment of 4.9 percent after considering the MIPS payment adjustment and the additional MIPS payment adjustment for exceptional performance. In addition, 10.5 percent of MIPS eligible clinicians would receive a negative payment adjustment among those that submit data. We finalized a performance threshold of 30 because we believe increasing the performance threshold to 30 points was not unreasonable or too steep, but rather a moderate step that encourages clinicians to gain experience with all MIPS performance categories. We refer readers to section III.I.3.j.(2) of this final rule for additional rationale on the selection of performance threshold.
To evaluate the impact of modifying the additional performance threshold, we ran two models with additional performance thresholds of 70 and 80 as an alternative to the finalized 75 points. We ran each of these models using a performance threshold of 30. The benefit of the model with the additional performance threshold of 70 would maintain the additional performance threshold that was in years 2 and 3. In the model with the additional performance threshold of 70, we estimate that $310 million would be redistributed through budget neutrality, and there would be a maximum payment adjustment of 3.9 percent after considering the MIPS payment adjustment and the additional MIPS payment adjustment for exceptional performance. In addition, 8.8 percent of MIPS eligible clinicians would receive a negative payment adjustment among those that submit data. In the model with an additional performance threshold of 80, for which the benefit was to assess the impact of the proposed additional performance threshold in the 2019 PFS proposed rule, we estimate that $310 million would be redistributed through budget neutrality, and that there would be a maximum payment adjustment of 6.1 percent after considering the MIPS payment adjustment and the additional MIPS payment adjustment for exceptional performance among those that submit data. Also, that 8.8 percent of MIPS eligible clinicians will receive a negative payment adjustment. We finalized the additional performance threshold at 75 points, which is halfway between our proposal of 80 and the CY 2018 MIPS performance period additional performance threshold at 70 because we believe raising the additional performance threshold, but for less than the original amount proposed, would incentivize continued improved performance while accounting for policy changes in the third year of the program. We refer readers to section III.I.3.j.(3) of this final rule for additional rationale on the selection of additional performance threshold.
To examine the impact of changes to the low-volume threshold on the number of MIPS eligible clinicians, we ran estimates for three different low-volume threshold criteria. As we discuss in section III.I.3.c of this final rule, we analyzed the impact of alternate low-volume thresholds because the low-volume threshold can affect the number of MIPS eligible clinicians and some public commenters were concerned about the associated impacts of the exclusions on the MIPS payment adjustments. When we set the third low volume threshold at 100 as an alternative to 200 covered professional services, we estimate that 32,828 clinicians would elect to opt-in for a total population of 802,915. When we apply the opt-in policy without adding the third finalized low-volume criterion at 200 covered professional services, we estimate that 12,242 clinicians would elect to opt-in for a total population of 782,329. When we lower the low-volume threshold criteria to $30,000 or fewer allowed charges for covered professional services; 100 or fewer Part B-enrolled individuals; and 100 or fewer furnished covered professional services to Medicare Part B-enrolled beneficiaries, we estimate a total of 871,238 MIPS eligible clinicians. To assess the impact of the number of MIPS eligible clinicians on payment adjustments, we ran a model with the lowest low-volume threshold and, therefore, highest number of MIPS eligible clinicians (871,238). We estimate that $440 million would be redistributed through budget neutrality. There would be a maximum payment adjustment of 5.0 percent after considering the MIPS payment adjustment and the additional MIPS payment adjustment for exceptional performance. In addition, 9.7 percent of MIPS eligible clinicians would receive a negative payment adjustment among those that submit data. These alternative low-volume thresholds were not selected because we did not observe a meaningful difference on the maximum payment adjustment from the finalized low-volume threshold in this final rule. As we stated in section III.I.3.c.(4) of this final rule, we will continue to strike a balance between ensuring sufficient participation in MIPS while also addressing the needs of small practices that may find it difficult to meet the program requirements. We refer readers to section III.I.3.c.(4) of this final rule for additional rationale on the selection of the low-volume threshold.
There are a number of changes in this final rule that will have an effect on beneficiaries. In general, we believe that many of these changes, including those intended to improve accuracy in payment through regular updates to the inputs used to calculate payments under the PFS, will have a positive impact and improve the quality and value of care provided to Medicare providers and beneficiaries.
All health care practitioners, as part of their routine record keeping activities, create and maintain documentation in the patient medical record for clinical and payment purposes. It is standard industry practice that when healthcare practitioners bill insurers, payers and health plans, such as Medicare, state plans under Title XIX, and commercial or other third party payers, for office and outpatient E/M services, that health care practitioners report the services using the common coding framework and definitions developed and maintained by the AMA CPT Editorial Panel. The 1995/1997 E/M services documentation guidelines provide guidance to medical practitioners regarding medical record documentation of E/M services based on the AMA CPT coding framework and definitions. In response to comments received from RFIs released to the public under our Patients Over Paperwork Initiative, we proposed to address medical documentation by simplifying the payment framework for E/M services and allowing greater flexibility on the components practitioners could choose to document when billing Medicare for E/M visits.
We estimate that the E/M visit documentation changes finalized in section II.I. of this final rule may significantly reduce the amount of time practitioners spend documenting office/outpatient E/M visits. Although little research is available on exactly how much time physicians and non-physician practitioners (NPPs) spend specifically documenting E/M visits, according to one recent estimate, primary care physicians spend on average, 84 minutes or 1.4 hours per day (24 percent of the time that they spend working within an EHR) documenting progress notes.
We stated our belief that our proposals to reduce redundancy in visit documentation, to allow auxiliary staff and the beneficiary to enter certain information in the medical record that would be verified but not required to be re-documented by the billing practitioner, to allow the choice of visit level and documentation based on MDM or time as alternatives to the current framework, and to require only minimum documentation (the amount required for a level 2 visit) for all visits except level 1 visits may reduce the documentation time by one quarter of the current time for the average office/outpatient visit. Under this assumption, we estimated these proposals would save clinicians approximately 1.6 minutes of time per office/outpatient E/M visit billed to Medicare. For a full-time practitioner whose panel of patients is 40 percent Medicare (60 percent other payers), this would translate to approximately 51 hours saved per year.
We noted that stakeholders had emphasized to us in public comments that whatever reductions may be made to the E/M documentation guidelines for purposes of Medicare payment, physicians and non-physician practitioners will still need to document substantial information in their progress notes for clinical, legal, operational, quality reporting and other purposes, as well as potentially for other payers. Furthermore, we recognized that there may be a ramp-up period for physicians and non-physician practitioners to implement the proposed documentation changes in their clinical workflow and EHR such that the effects of mitigating documentation burden may not be immediately realized. Accordingly, we believed the total amount of time practitioners spend on E/M visit documentation may remain high, despite the time savings that we estimated in our proposed rule could result from our E/M documentation proposals. These and all other improvements to payment accuracy that we proposed for CY 2019 were described in greater detail in section II.I. of the proposed rule. We welcomed public comments on our assumptions for the estimated reduction in documentation burden related to our E/M visit proposals.
Many commenters stated there would be significant burden and cost to update EHRs and educate and train coders, staff and auditors. Also, they noted that without appropriate medical documentation for each visit, the proposals might result in insufficient documentation by one member of the care team that another member might have to make up for, and that fractured care from incomplete or insufficient documentation might inadvertently create additional burdens, as well as impact quality of care. While many commenters supported allowing a choice in documentation methodology (current framework, medical decision-making, or time), other commenters noted such a policy would increase burden due to increased variation in how visits would be documented, and the need to restructure EHR templates to accommodate different options and decide which method was best for a given patient or practice. Most of the commenters noted our proposals regarding billing eligibility and supporting documentation for the proposed add-on codes for primary care, other specialty care, prolonged services, and documenting using time were unclear and might create new burdens that would equal or exceed the current
Other commenters were concerned about impacts on MA plan payments, plan quality, and provider access. Some commenters were concerned that paying for visits based on a single rate would not allow an understanding of the complexity of care being delivered and might lead to abuse. Another commenter noted that the proposed add-on codes to account for care complexity would increase complexity and result in a need for perpetual fixes from unanticipated consequences. Similar to other commenters, this commenter was concerned that a single payment rate would redistribute payments without reducing the burden associated with determining the right codes, because the coding structure would remain the same. The commenter also expressed concern that practitioners would be less willing to see complex patients, and that the proposal would incentivize gaming by certain specialties to make up for lost revenue. The commenter's preferred approach was to simplify the current guidelines and rather than implement a single payment rate, CMS should wait for the AMA/CPT's E/M workgroup results. Finally, the commenter recommended that if CMS finalized as proposed, CMS should phase implementation and create a monitoring process.
We note that we believe that time physicians spend fulfilling current documentation requirements on evenings and weekends are burdensome, and that even if that additional time would not necessarily be spent seeing additional patients, that time is a quantifiable resource cost to physicians and other practitioners.
After considering the comments, we adjusted our proposed burden reduction estimate, including our estimates on the documentation of an average outpatient/office E/M. We are still assuming an average of 20 patient visits per day, one E/M visit per patient, but instead are using the more conservative figure of 1.4 hours per day spent documenting E/M visits that we identified in our review of available research. As a result, we estimate that documentation of an average outpatient/office E/M visit takes 4.2 minutes versus our initial estimate of 6.3 minutes. The final rule estimated time savings is monetized into practitioner wages and summarized as follows.
We calculated the time savings associated with documentation changes annually, and converted this time to practitioner wages using 2016 hourly wage data from the Bureau of Labor Statistics (BLS)
The estimated savings for 2019 and 2020 are for the initial changes to documentation in these years (those not impacted by coding and payment changes, including provisions to no longer require documentation of the medical necessity of a home visit in lieu of an office visit and to expand current policy reducing the need to re-document prior data in the medical record). These savings would impact levels 2 through 5 visits, and are estimated to save 0.11 minutes
Additional savings are estimated annually starting in 2021 for the finalized payment and coding-related changes. These savings would impact levels 3 and 4 visits, and are estimated to save 0.63 minutes
As noted in section II.D. of this final rule, for CY 2019, we aimed to increase access for Medicare beneficiaries to physicians' services that are routinely furnished via communication technology by clearly recognizing a discrete set of services that are defined by and inherently involve the use of communication technology. Accordingly, we made several proposals for modernizing Medicare physician payment for communication technology-based services.
The use of communication technology-based services will provide new options for physicians to treat patients. These services could help to avoid unnecessary office visits, could consist of services that are already occurring but are not being separately paid, or could constitute new services. Medicare would pay $14 per visit in the first year for these communication technology-based services, compared with $92 per visit for the corresponding established patient visits.
Practitioners have a choice of when to use the communication technology-based services. Because of the low payment rate relative to that for an office visit, we are assuming that usage of these services will be relatively low. In addition, we expect that the number of new or newly billable visits and subsequent treatments will outweigh the number of times that communication technology-based services will be used instead of more costly services. As a result, we expect that the financial impact of paying for the communication technology-based services will be an increase in Medicare costs. We estimate that usage of these services will result in fewer than 1 million visits in the first year but will eventually result in more than 19 million visits per year, ultimately increasing payments under the PFS by about 0.2 percent. In order to maintain budget neutrality in setting proposed rates for CY 2019, we assumed the number of services that would result in a 0.2 percent reduction in the CF.
As with all estimates, and particularly those for new separately billable services, this outcome is highly uncertain. Because recognition of communication technology-based services is a new area for healthcare coverage, the available information on which to base estimates is limited and is usually not directly applicable, particularly to a new Medicare payment. The cost and utilization estimates are based on Medicare claims data together with a study published in
We proposed to make separate payment for these services when furnished by RHCs and FQHCs. A potential estimate of utilization and overall cost of these services by RHCs and FQHCs could be derived by comparing their use of chronic care management and other care management services to the same services furnished by practitioners paid under the PFS, since these care management services are also separately billable and do not take place in-person. Based on this comparison, and without considering potential variables and issues specific to these services, the impact the finalized policy would be less than $1 million in additional Medicare spending in the first year and could eventually result in up to $20 million in spending per year in future years. These estimates are uncertain and could change after further consideration of the potential variables and issues specific to these services.
As noted in section II.M. of this final rule, we are finalizing our proposal to end functional reporting for outpatient therapy services as part of our burden reduction efforts in response to the RFI on CMS Flexibilities and Efficiencies that was issued in the CY 2018 PFS proposed rule (82 FR 34172 through 34173). Under our functional reporting system therapy practitioners and providers are required to report, whenever functional reporting is required, non-payable HCPCS G-codes and modifiers—typically in pairs—to convey information about the beneficiary's functional limitation category and functional status throughout the PT, OT, or SLP episode of care. In addition, each time functional reporting is required on the claim, the therapy provider must also document the functional reporting G-codes and their modifiers in the medical record. In this final rule, we are finalizing our proposal to eliminate this requirement that therapy practitioners and providers report HCPCS G-codes and modifiers or document in the medical record to convey functional reporting status for PT, OT or SLP episode of care.
To quantify the amount of burden reduction, we estimated the total amount of time that therapy practitioners spend doing functional reporting. To do this, we first looked at our data for CY 2017 for professional claims by the type of plan of care reported primarily by therapists in private practice (TPPs), including physical therapists, occupational therapists, and speech-language pathologists. We found that the overall utilization of the 42 functional reporting HCPCS G-codes totaled 15,456,421 single units, or 7,728,211 pairs.
We then considered the time, on average, it might take to report on the claim and document in the medical record each pair of HCPCS G-codes. We noted this includes the time it takes to make the initial determination of the HCPCS G-code functional limitation category, as well as the time needed to make each initial and/or subsequent assignments for the applicable severity modifiers in order to define the patient's functional status. We then made the assumption that it would take between 1 minute and 1.5 minutes, on average, to report the HCPCS G-code and modifier pair each time functional reporting is required. Using the total utilization of G-code pairs and the range of 1 minute to 1.5 minutes, we
Because therapy services are also furnished by providers of outpatient therapy services such as hospitals, SNFs and rehabilitation agencies that submit institutional claims, typically representing a greater amount of expenditures than practitioners submitting professional claims, we calculated additional savings for these providers using the same time assumptions of 1 to 1.5 minutes to report the HCPCS G-code and modifier pair each time functional reporting is required. Our 2017 data showed a total utilization of the functional reporting HCPCS G-codes is 29,053,921 single units, or 14,526,961 pairs, indicating that therapy providers would collectively save between 242,116 to 363,174 hours (or 14,526,961 to 21,790,442 minutes) for CY 2017 if the functional reporting requirements had not been effective during that year.
As discussed in section II.M. of this final rule, we received many comments on our burden reduction proposal to eliminate our functional reporting requirements, and nearly all comments were supportive. We believe it is reasonable to estimate that in CY 2019 TPPs and other practitioners submitting professional claims and therapists working for providers submitting institutional claims will collectively save, at a minimum, the same number of collective hours we calculated they would save for CY 2017, as specified previously in this RIA, with dates of service on and after January 1, 2019.
We believe that the changes to the physician supervision requirements for RAs furnishing diagnostic imaging procedures as described in section II.F. of this final rule will significantly reduce burden for physicians. While approximately 215,000 diagnostic imaging services per year are currently performed that require personal supervision, we are not able to determine the number of these services that are performed by an RA due to limitations in the claims data. As a result, we are not able to quantify the amount of time potentially saved by physicians and practitioners under the policy we are finalizing to require direct supervision of diagnostic imaging procedures done by RAs in cases where personal supervision would ordinarily be required. That said, stakeholders representing the practitioner community have indicated that changing the required supervision level for RAs will result in a redistribution of workload from radiologists to RAs, potentially resulting in improved practice efficiency and patient satisfaction. Stakeholders have stated that practitioners that utilize RAs have experienced improvements in practice efficiency, as use of RAs allows radiologists more time for professional services such as interpretation of images, and these practitioners cite greater flexibility that results in reduced wait times. Furthermore, stakeholders contend that the Medicare supervision requirements currently create disincentives to use RAs, as practitioners cannot make full use of them for Medicare patients, and the change to the supervision requirement would allow RAs to be more fully utilized. For these reasons, we believe the change in supervision requirements we are finalizing for RAs will contribute to burden reduction for physicians and practitioners providing diagnostic imaging procedures for Medicare beneficiaries.
Many proposed policy changes could result in a change in beneficiary liability as it relates to coinsurance (which is 20 percent of the fee schedule amount, if applicable for the particular provision after the beneficiary has met the deductible). To illustrate this point, as shown in our public use file Impact on Payment for Selected Procedures available on the CMS website at
There are several changes in this rule that would have an effect on beneficiaries. In general, we believe that many of these changes, including those intended to improve accuracy in payment through regular updates to the inputs used to calculate payments under the PFS, would have a positive impact and improve the quality and value of care provided to Medicare beneficiaries. For example, several of the new proposed measures include patient-reported outcomes, which may be used to help patients make more informed decisions about treatment options. Patient-reported outcome measures provide information on a patient's health status from the patient's point of view and may also provide valuable insights on factors such as quality of life, functional status, and overall disease experience, which may not otherwise be available through routine clinical data collection. Patient-reported outcomes are factors frequently of interest to patients when making decisions about treatment.
We estimate that CY 2019 Quality Payment Program 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.
If regulations impose administrative costs on private entities, such as the time needed to read and interpret this rule, we should estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that will review the rule, we assume that the total number of unique commenters on last year's rule will be the number of reviewers of this rule. We acknowledge that this assumption may understate or overstate the costs of reviewing this rule. It is possible that not all commenters reviewed last year's rule in detail, and it is also possible that some reviewers chose not to comment on the rule. For these reasons we thought that the number of past commenters would be a fair estimate of the number of reviewers of this rule. We welcomed any comments on the approach in estimating the number of entities which will review this rule.
We also recognize that different types of entities are in many cases affected by mutually exclusive sections of this rule, and therefore for the purposes of our estimate we assume that each reviewer reads approximately 50 percent of the rule. We sought comments on this assumption.
Using the wage information from the BLS for medical and health service managers (Code 11-9111), we estimate that the cost of reviewing this rule is $107.38 per hour, including overhead and fringe benefits
As required by OMB Circular A-4 (available at
The analysis in the previous sections, together with the remainder of this preamble, provided an initial Regulatory Flexibility Analysis. The previous analysis, together with the preceding portion of this preamble, provides an RIA. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.
Administrative practice and procedure, Diseases, Health facilities, Health professions, Medical devices, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays.
Health facilities, Health professions, Kidney diseases, Laboratories, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays.
Diseases, Medicare, Reporting and recordkeeping requirements.
Administrative practice and procedure, Biologics, Drugs, Health facilities, Health professions, Kidney diseases, Medicare, Reporting and recordkeeping requirements.
Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.
Administrative practice and procedure, Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.
Administrative practice and procedure, Health facilities, Health maintenance organizations (HMO), Health professions, Health records, Medicaid, Medicare, Penalties, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR chapter IV as set forth below:
42 U.S.C. 405(a), 1302, 1320b-12, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k)) and 42 U.S.C. 263a.
The revisions read as follows:
(b) * * *
(g) To receive payment, the RHC or FQHC must do all of the following:
The revisions and additions read as follows:
(a) * * *
(1) Except as specified in paragraphs (d) and (e) of this section, an RHC that is authorized to bill under the reasonable cost system is paid an all-inclusive rate that is determined by the MAC at the beginning of the cost reporting period.
(b)
(c)
(d)
(e)
42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd.
(b) * * *
(4)
(c)
The additions and revision read as follows:
(b) * * *
(3) * * *
(ix) A renal dialysis facility (only for purposes of the home dialysis monthly ESRD-related clinical assessment in section 1881(b)(3)(B) of the Act);
(x) The home of an individual (only for purposes of the home dialysis ESRD-related clinical assessment in section 1881(b)(3)(B) of the Act).
(xi) A mobile stroke unit (only for purposes of diagnosis, evaluation, or treatment of symptoms of an acute stroke provided in accordance with section 1834(m)(6) of the Act).
(xii) The home of an individual (only for purposes of treatment of a substance use disorder or a co-occurring mental health disorder, furnished on or after July 1, 2019, to an individual with a substance use disorder diagnosis.
(4) Except as provided in paragraph (b)(4)(iv) of this section, originating sites must be:
(iv) The geographic requirements specified in paragraph (b)(4) of this section do not apply to the following telehealth services:
(A) Home dialysis monthly ESRD-related clinical assessment services furnished on or after January 1, 2019, at an originating site described in paragraphs (b)(3)(vi), (ix) or (x) of this section, in accordance with section 1881(b)(3)(B) of the Act; and
(B) Services furnished on or after January 1, 2019, for purposes of diagnosis, evaluation, or treatment of symptoms of an acute stroke.
(C) Services furnished on or after July 1, 2019 to an individual with a substance use disorder diagnosis, for purposes of treatment of a substance use disorder or a co-occurring mental health disorder.
42 U.S.C. 1302, 1395w-101 through 1395w-152, 1395hh, and 1395nn.
The revision reads as follows:
(g) * * *
(1) An entity may submit a claim or bill and payment may be made to an entity that submits a claim or bill for a designated health service if—
(i) The compensation arrangement between the entity and the referring physician fully complies with an applicable exception in this subpart except with respect to the signature requirement of the exception; and
(ii) The parties obtain the required signature(s) within 90 consecutive calendar days immediately following the date on which the compensation arrangement became noncompliant and the compensation arrangement otherwise complies with all criteria of the applicable exception.
(2) [Reserved]
(e)
(2)
42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).
The revision and addition reads as follows:
(a)
(b) * * *
(3) No originating site facility fee payment is made to an originating site described in § 410.78(b)(3)(x), (xi), or (xii); or to an originating site for services furnished under the exception at § 410.78(b)(4)(iv)(A) or (B) of this chapter.
The revisions read as follows:
(b) * * *
(i) * * *
(3) Significant hardships for ordering professionals who experience any of the following:
(i) Insufficient internet access.
(ii) EHR or CDSM vendor issues.
(iii) Extreme and uncontrollable circumstances.
(j)
(2) Ordering professionals may delegate the consultation with specified applicable AUC required under paragraph (j)(1) of this section to clinical staff acting under the direction of the ordering professional.
(k)
(2) * * *
(i) For hospital outreach laboratories—bills Medicare Part B on the CMS 1450 under bill type 14x;
(ii) [Reserved]
(3) In a data collection period, receives more than 50 percent of its Medicare revenues, which includes fee-for-service payments under Medicare Parts A and B, prescription drug payments under Medicare Part D, and any associated Medicare beneficiary deductible or coinsurance for services furnished during the data collection period from one or a combination of the following sources:
The revision reads as follows:
(c) * * *
(8)
The revisions and additions read as follows:
(1) For the 2019 and 2020 MIPS payment years, 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 ambulatory surgical center setting based on claims for a period prior to the performance period as specified by CMS; and
(2) Beginning with the 2021 MIPS payment year, 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 ambulatory surgical center setting based on claims for the MIPS determination period.
(1) For the 2019 and 2020 MIPS payment years, an outcome (including intermediate-outcome and patient-reported outcome), appropriate use, patient safety, efficiency, patient experience, or care coordination quality measure.
(2) Beginning with the 2021 MIPS payment year, an outcome (including intermediate-outcome and patient-reported outcome), appropriate use, patient safety, efficiency, patient experience, care coordination, or opioid-related quality measure.
(1) For the 2019 and 2020 MIPS payment years, 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, on-campus outpatient hospital, off campus-outpatient hospital, or emergency room setting based on claims for a period prior to the performance period as specified by CMS; and
(2) Beginning with the 2021 MIPS payment year, 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, off campus outpatient hospital, or emergency room setting based on claims for the MIPS determination period.
(1) For the 2019 MIPS payment year, the low-volume threshold that applies to an individual eligible clinician, group, or APM Entity group that, during the low-volume threshold determination period described in paragraph (4) of this definition, has Medicare Part B allowed charges less than or equal to $30,000 or provides care for 100 or fewer Medicare Part B-enrolled individuals.
(2) For the 2020 MIPS payment year, the low-volume threshold that applies to an individual eligible clinician, group, or APM Entity group that, during the low-volume threshold determination period described in paragraph (4) of this definition, has allowed charges for covered professional services less than or equal to $90,000 or furnishes covered professional services to 200 or fewer Medicare Part B-enrolled individuals.
(3) Beginning with the 2021 MIPS payment year, the low-volume threshold that applies to an individual eligible clinician, group, or APM Entity group that, during the MIPS determination period, has allowed charges for covered professional services less than or equal to $90,000, furnishes covered professional services to 200 or fewer Medicare Part B-enrolled individuals, or furnishes 200 or fewer covered professional services to Medicare Part B-enrolled individuals.
(4) For the 2019 and 2020 MIPS payment years, 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 to 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, group, or APM Entity 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, each segment of the low-volume threshold determination period includes a 30-day claims run out.
(1) Beginning with the 2021 MIPS payment year, a 24-month assessment period consisting of:
(i) An initial 12-month segment beginning on October 1 of the calendar year 2 years prior to the applicable performance period and ending on September 30 of the calendar year preceding the applicable performance period, and that includes a 30-day claims run out; and
(ii) A second 12-month segment beginning on October 1 of the calendar year preceding the applicable performance period and ending on September 30 of the calendar year in which the applicable performance period occurs.
(2) Subject to § 414.1310(b)(1)(iii), an individual eligible clinician, group, or APM Entity group that is identified as not exceeding the low-volume threshold
(1) For the 2019 and 2020 MIPS payment years:
(i) A physician (as defined in section 1861(r) of the Act);
(ii) A physician assistant, a nurse practitioner, and clinical nurse specialist (as such terms are defined in section 1861(aa)(5) of the Act);
(iii) A certified registered nurse anesthetist (as defined in section 1861(bb)(2) of the Act); and
(iv) A group that includes such clinicians.
(2) For the 2021 MIPS payment year and future years:
(i) A clinician described in paragraph (1) of this definition;
(ii) A physical therapist or occupational therapist;
(iii) A qualified speech-language pathologist;
(iv) A qualified audiologist (as defined in section 1861(ll)(3)(B) of the Act);
(v) A clinical psychologist (as defined by the Secretary for purposes of section 1861(ii) of the Act);
(vi) A registered dietician or nutrition professional; and
(vii) A group that includes such clinicians.
(1) For the 2019 and 2020 MIPS payment year, 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 paragraph (3) of this definition, during the non-patient facing determination period described in paragraph (4) of this definition, and a group or virtual group provided that more than 75 percent of the NPIs billing under the group's TIN or virtual group's TINs, as applicable, meet the definition of a non-patient facing individual MIPS eligible clinician.
(2) Beginning with the 2021 MIPS payment year, 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 paragraph (3) of this definition, during the MIPS determination period, and a group or virtual group provided that more than 75 percent of the NPIs billing under the group's TIN or virtual group's TINs, as applicable, meet the definition of a non-patient facing individual MIPS eligible clinician.
(3) 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.
(4) For the 2019 and 2020 MIPS payment year, 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.
(1) For the 2019, 2020 and 2021 MIPS payment year, a CMS-approved entity that has self-nominated and successfully completed a qualification process to determine whether the entity may collect medical or clinical data for the purpose of patient and disease tracking to foster improvement in the quality of care provided to patients.
(2) Beginning with the 2022 MIPS payment year, an entity that demonstrates clinical expertise in medicine and quality measurement development experience and collects medical or clinical data on behalf of a MIPS eligible clinician for the purpose of patient and disease tracking to foster improvement in the quality of care provided to patients.
(1) For the 2019 MIPS payment year, a TIN consisting of 15 or fewer eligible clinicians.
(2) For the 2020 MIPS payment year, a TIN consisting of 15 or fewer eligible clinicians during a 12-month assessment period 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 includes a 30-day claims run out.
(3) Beginning with the 2021 MIPS payment year, a TIN consisting of 15 or fewer eligible clinicians during the MIPS determination period.
(a)
(b) * * *
(1) * * *
(ii) Is a Partial Qualifying APM Participant and does not elect to participate in MIPS as a MIPS eligible clinician; or
(iii) Does not exceed the low-volume threshold. Beginning with the 2021 MIPS payment year, if an individual eligible clinician, group, or APM Entity group in a MIPS APM exceeds at least one, but not all, of the low-volume threshold criteria and elects to participate in MIPS as a MIPS eligible clinician, the individual eligible clinician, group, or APM Entity group is treated as a MIPS eligible clinician for the applicable MIPS payment year. For such solo practitioners and groups that elect to participate in MIPS as a virtual group (except for APM Entity groups in MIPS APMs), the virtual group election under § 414.1315 constitutes an election under this paragraph and results in the solo practitioners and groups being treated as MIPS eligible clinicians for the applicable MIPS payment year. For such APM Entity groups in MIPS APMs, only the APM Entity group election can result in the APM Entity group being treated as MIPS eligible clinicians for the applicable MIPS payment year.
(d)
(e) * * *
(1) Except as provided under § 414.1370(f)(2), each MIPS eligible clinician in the group will receive a MIPS payment adjustment factor (or additional MIPS payment adjustment factor) based on the group's combined performance assessment.
(2) For individual MIPS eligible clinicians to participate in MIPS as a group, all of the following requirements must be met:
(i) Groups must meet the definition of a group at all times during the applicable performance period.
(ii) Individual eligible clinicians that elect to participate in MIPS as a group must aggregate their performance data across the group's TIN.
(iii) Individual eligible clinicians that elect to participate in MIPS as a group will have their performance assessed at the group level across all four MIPS performance categories.
(iv) Groups must adhere to an election process established by CMS, as applicable.
(a)
(2) Except as provided under § 414.1370(f)(2), each MIPS eligible clinician in the virtual group receives a MIPS payment adjustment factor and, if applicable, an additional MIPS payment adjustment factor based on the virtual group's combined performance assessment.
(b)
(c)
(1)
(ii) Beginning with the 2021 MIPS payment year, the virtual group eligibility determination period is the first segment of the MIPS determination period.
(2)
(ii) A designated virtual group representative must submit an election, on behalf of the solo practitioners and groups that compose a virtual group, to participate in MIPS as a virtual group for a performance period in a form and manner specified by CMS by the election deadline specified in paragraph (b) of this section. The virtual group election must include each TIN and NPI associated with the virtual group and contact information for the virtual group representative.
(iii) After 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 data submission.
(3)
(i) Identifies each party by name, TIN, and each NPI under the TIN, and includes as parties only the solo practitioners and groups that compose the virtual group.
(ii) Is for a term of at least one performance period.
(iii) Requires each party to notify each NPI under the party's TIN regarding their participation in the MIPS as a virtual group.
(iv) Sets forth each NPI's rights and obligations in, and representation by, the virtual group, including, but not limited to, the reporting requirements and how participation in the MIPS as a virtual group affects the NPI's ability to participate in the MIPS outside of the virtual group.
(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.
(vi) Requires each party to update its Medicare enrollment information, including the addition or removal of NPIs billing under its TIN, on a timely basis in accordance with Medicare program requirements and to notify the other parties of any such changes within 30 days of the change.
(vii) Requires completion of a close-out process upon termination or expiration of the agreement that requires each party to furnish all data necessary for the parties to aggregate their data across the virtual group's TINs.
(viii) Expressly requires each party to participate in the MIPS as a virtual group and comply with the requirements of the MIPS and all other applicable laws (including, but not limited to, Federal criminal law, the Federal False Claims Act, the Federal
(ix) Is executed on behalf of each party by an individual who is authorized to bind the party.
(d)
(1) Virtual groups must meet the definition of a virtual group at all times during the applicable performance period.
(2) Solo practitioners and groups of 10 or fewer eligible clinicians that elect to participate in MIPS as a virtual group must aggregate their performance data across the virtual group's TINs.
(3) Solo practitioners and groups of 10 or fewer eligible clinicians that elect to participate in MIPS as a virtual group will have their performance assessed at the virtual group level across all four MIPS performance categories.
(4) Virtual groups must adhere to the election process described in paragraph (c) of this section.
(b) * * *
(2) Promoting Interoperability and improvement activities performance categories is a minimum of a continuous 90-day period within CY 2018, up to and including the full CY 2018 (January 1, 2018 through December 31, 2018).
(c) * * *
(2) Promoting Interoperability 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).
(d) Beginning with the 2022 MIPS payment year, the performance period for:
(1) The quality and cost performance categories is the full calendar year (January 1 through December 31) that occurs 2 years prior to the applicable MIPS payment year.
(2) The improvement activities performance categories is a minimum of a continuous 90-day period within the calendar year that occurs 2 years prior to the applicable MIPS payment year, up to and including the full calendar year.
(e) For purposes of the 2022 MIPS payment year, the performance period for:
(1) The Promoting Interoperability performance category is a minimum of a continuous 90-day period within the calendar year that occurs 2 years prior to the applicable MIPS payment year, up to and including the full calendar year.
(2) [Reserved]
(a)
(2) There are no data submission requirements for:
(i) The cost performance category or administrative claims-based quality measures. Performance in the cost performance category and on such measures is calculated by CMS using administrative claims data, which includes claims submitted with dates of service during the applicable performance period that are processed no later than 60 days following the close of the applicable performance period.
(ii) The quality and cost performance categories, as applicable, for MIPS eligible clinicians and groups that are scored under the facility-based measurement scoring methodology described in § 414.1380(e).
(b)
(1) For the quality performance category, the direct, login and upload, and Medicare Part B claims (beginning with the 2021 MIPS payment year for small practices only) submission types.
(2) For the improvement activities or Promoting Interoperability performance categories, the direct, login and upload, or login and attest submission types.
(c)
(1) For the quality performance category, the direct, login and upload, Medicare Part B claims (beginning with the 2021 MIPS payment year, for small practices only), and CMS Web Interface (for groups consisting of 25 or more eligible clinicians or a third party intermediary submitting on behalf of a group) submission types.
(2) For the improvement activities or Promoting Interoperability performance categories, the direct, login and upload, or login and attest submission types.
(d)
(e)
(1) For the direct, login and upload, login and attest, and CMS Web Interface submission types, March 31 following the close of the applicable performance period or a later date as specified by CMS.
(2) For the Medicare Part B claims submission type, data must be submitted on claims with dates of service during the applicable performance period that must be processed no later than 60 days following the close of the applicable performance period.
(a) For a MIPS payment year, CMS uses the following quality measures, as applicable, to assess performance in the quality performance category:
(1) Measures included in the MIPS final list of quality measures established by CMS through rulemaking;
(2) QCDR measures approved by CMS under § 414.1400;
(3) Facility-based measures described in § 414.1380; and
(4) MIPS APM measures described in § 414.1370.
(b) Unless a different scoring weight is assigned by CMS, performance in the quality performance category comprises:
(1) 60 percent of a MIPS eligible clinician's final score for MIPS payment year 2019.
(2) 50 percent of a MIPS eligible clinician's final score for MIPS payment year 2020.
(3) 45 percent of a MIPS eligible clinician's final score for MIPS payment year 2021.
(a) * * *
(1)
(ii) MIPS eligible clinicians and groups that report on a specialty or subspecialty measure set, as designated in the MIPS final list of quality measures established by CMS through rulemaking, must submit data on at least six measures within that set, including at least one outcome measure. If an applicable outcome measure is not available, report one other high priority measure. If the set contains fewer than six measures or if fewer than six measures within the set apply to the MIPS eligible clinician or group, report on each measure that is applicable.
(2)
(ii) [Reserved]
(3)
(ii) [Reserved]
(a) MIPS eligible clinicians and groups submitting quality measures data on QCDR measures, MIPS CQMs, or eCQMs must submit data on:
(b) MIPS eligible clinicians and groups submitting quality measure data on Medicare Part B claims measures must submit data on:
(c) Groups submitting quality measures data on CMS Web Interface measures or the CAHPS for MIPS survey must submit data on the sample of the Medicare Part B patients CMS provides, as applicable.
(1)
(ii) [Reserved]
(2) [Reserved]
(a)
(b)
(2) For the total per capita cost measure, beneficiaries are attributed using a method generally consistent with the method of assignment of beneficiaries under § 425.402 of this chapter.
(3) For the Medicare Spending per Beneficiary (MSPB) measure, an episode is attributed to the MIPS eligible clinician who submitted the plurality of claims (as measured by allowed charges) for Medicare Part B services rendered during an inpatient hospitalization that is an index admission for the MSPB measure during the applicable performance period.
(4) For the acute condition episode-based measures specified for the 2017 performance period, an episode is attributed to each MIPS eligible clinician who bills at least 30 percent of inpatient evaluation and management (E&M) visits during the trigger event for the episode.
(5) For the procedural episode-based measures specified for the 2017 performance period, an episode is attributed to each MIPS eligible clinician who bills a Medicare Part B claim with a trigger code during the trigger event for the episode.
(6) For the acute inpatient medical condition episode-based measures specified beginning with the 2019 performance period, an episode is attributed to each MIPS eligible clinician who bills inpatient E&M claim lines during a trigger inpatient hospitalization under a TIN that renders at least 30 percent of the inpatient E&M claim lines in that hospitalization.
(7) For the procedural episode-based measures specified beginning with the 2019 performance period, an episode is attributed to each MIPS eligible clinician who renders a trigger service as identified by HCPCS/CPT procedure codes.
(c)
(2) For the Medicare spending per beneficiary measure, the case minimum is 35.
(3) For the episode-based measures specified for the 2017 performance period, the case minimum is 20.
(4) For the procedural episode-based measures specified beginning with the 2019 performance period, the case minimum is 10.
(5) For the acute inpatient medical condition episode-based measures specified beginning with the 2019 performance period, the case minimum is 20.
(d)
(1) Zero percent of a MIPS eligible clinician's final score for MIPS payment year 2019.
(2) 10 percent of a MIPS eligible clinician's final score for MIPS payment year 2020.
(3) 15 percent of a MIPS eligible clinician's final score for MIPS payment year 2021.
(a) For a MIPS payment year, CMS uses improvement activities included in the MIPS final inventory of improvement activities established by CMS through rulemaking to assess performance in the improvement activities performance category.
(b) Unless a different scoring weight is assigned by CMS under section 1848(q)(5)(F) of the Act, performance in the improvement activities performance category comprises:
(c) The following are the list of subcategories, of which, with the exception of Participation in an APM, include activities for selection by a MIPS eligible clinician or group:
(1) Expanded practice access, such as same day appointments for urgent needs and after-hours access to clinician advice.
(2) Population management, such as monitoring health conditions of
(3) Care coordination, such as timely communication of test results, timely exchange of clinical information to patients or other clinicians, and use of remote monitoring or telehealth.
(4) Beneficiary engagement, such as the establishment of care plans for individuals with complex care needs, beneficiary self-management assessment and training, and using shared decision making mechanisms.
(5) Patient safety and practice assessment, such as through the use of clinical or surgical checklists and practice assessments related to maintaining certification.
(6) Participation in an APM.
(7) Achieving health equity, such as for MIPS eligible clinicians that achieve high quality for underserved populations, including persons with behavioral health conditions, racial and ethnic minorities, sexual and gender minorities, people with disabilities, people living in rural areas, and people in geographic HPSAs.
(8) Emergency preparedness and response, such as measuring MIPS eligible clinician participation in the Medical Reserve Corps, measuring registration in the Emergency System for Advance Registration of Volunteer Health Professionals, measuring relevant reserve and active duty uniformed services MIPS eligible clinician activities, and measuring MIPS eligible clinician volunteer participation in domestic or international humanitarian medical relief work.
(9) Integrated behavioral and mental health, such as measuring or evaluating such practices as: Co-location of behavioral health and primary care services; shared/integrated behavioral health and primary care records; cross training of MIPS eligible clinicians, and integrating behavioral health with primary care to address substance use disorders or other behavioral health conditions, as well as integrating mental health with primary care.
(a) * * *
(1)
The revisions read as follows:
(b) * * *
(3) The APM bases payment on quality measures and cost/utilization; and
(f) * * *
(2) MIPS eligible clinicians who participate in a group or 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 group or 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; if the APM Entity group is exempt from MIPS all eligible clinicians within that APM Entity group are also exempt from MIPS.
(g) * * *
(4)
(ii) For the 2019 and 2020 MIPS payment years, 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 Promoting Interoperability performance category. Beginning with the 2021 MIPS payment year, for APM Entities in MIPS APMs including 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 Promoting Interoperability performance category. The score for each MIPS eligible clinician is the higher of either:
(A) A group score based on the measure data for the Promoting Interoperability performance category reported by a TIN for the MIPS eligible clinician according to MIPS submission and reporting requirements for groups; or
(B) An individual score based on the measure data for the Promoting Interoperability performance category reported by the MIPS eligible clinician according to MIPS submission and reporting requirements for individuals.
(iii) In the event that a MIPS eligible clinician participating in a MIPS APM receives an exception from the Promoting Interoperability performance category reporting requirements, such eligible clinician will be assigned a null score when CMS calculates the APM Entity's Promoting Interoperability performance category score under the APM scoring standard.
(A) If all MIPS eligible clinicians in an APM Entity have been excepted from reporting the Promoting Interoperability performance category, the performance category weight will be reweighted to zero for the APM Entity for that MIPS performance period.
(B) [Reserved]
(h) * * *
(4)
(5) * * *
(i) * * *
(A) In 2017, the improvement activities performance category is reweighted to 25 percent and the Promoting Interoperability performance category is reweighted to 75 percent; and
(B) Beginning in 2018, the Promoting Interoperability performance category is reweighted to 75 percent and the improvement activities performance category is reweighted to 25 percent.
(ii) If CMS reweights the Promoting Interoperability performance category to zero percent:
(a)
(b)
(2)
(i) For the 2019 and 2020 MIPS payment years: For each base score measure, as applicable, report the numerator (of at least one) and denominator, or yes/no statement, or claim an exclusion for each measure that includes an option for an exclusion; and
(ii) For the 2021 and 2022 MIPS payment years:
(A) Report that the MIPS eligible clinician completed the actions included in the Security Risk Analysis measure during the year in which the performance period occurs; and
(B) For each required measure, as applicable, report the numerator (of at least one) and denominator, or yes/no statement, or 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 2024 MIPS payment year, improvement scoring is available in the cost performance category.
(iii) For the improvement activities performance category, each improvement activity is assigned a certain number of points. The points for all submitted activities are summed and scored against a total potential performance category score of 40 points.
(iv) For the Promoting Interoperability performance category, each measure is scored against a maximum number of points. The points for all submitted measures are summed and scored against a total potential performance category score of 100 points.
(2) [Reserved]
(b)
(1)
(A)
(
(
(
(B)
(
(
(
(
(ii)
(A) Each benchmark must have a minimum of 20 individual clinicians or groups who reported the measure meeting the case minimum requirement at paragraph (b)(1)(iii) of this section and the data completeness requirement at § 414.1340 and having a performance rate that is greater than zero.
(B) CMS Web Interface collection type uses benchmarks from the corresponding reporting year of the Shared Savings Program.
(iii)
(iv)
(A) For the 2020 MIPS payment year, each topped out measure specified by CMS through rulemaking receives no more than 7 measure achievement points, provided that the benchmark for the applicable collection type is identified as topped out in the benchmarks published for the 2018 MIPS performance period.
(B) Beginning with the 2021 MIPS payment year, each measure (except for measures in the CMS Web Interface) for which the benchmark for the applicable collection type is identified as topped out for 2 or more consecutive years receives no more than 7 measure achievement points in the second consecutive year it is identified as topped out, and beyond.
(v)
(A)
(
(
(
(B)
(
(
(C)
(vi)
(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)(vii) 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)(vii) of this section.
(F) For the purpose of improvement scoring methodology, the term “fully participate” means the MIPS eligible
(vii)
(A) Beginning with the 2021 MIPS payment year, for each measure that a MIPS eligible clinician submits that is significantly impacted by clinical guideline changes or other changes that CMS believes may result in patient harm or misleading results, the total available measure achievement points are reduced by 10 points.
(B) Beginning with the 2021 MIPS payment year, for groups that submit 5 or fewer measures and register for the CAHPS for MIPS survey but do not meet the minimum beneficiary sampling requirements, the total available measure achievement points are reduced by 10 points.
(viii)
(2)
(i) Cost measure benchmarks are determined by CMS based on cost measure performance during the performance period. At least 20 MIPS eligible clinicians or groups must meet the minimum case volume specified under § 414.1350(c) for a cost measure in order for a benchmark to be determined for the measure. If a benchmark is not determined for a cost measure, the measure will not be scored.
(ii) A MIPS eligible clinician must meet the minimum case volume specified under § 414.1350(c) to be scored on a cost measure.
(iii) The 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) The cost improvement score is determined for a MIPS eligible clinician that demonstrates 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 2 consecutive performance periods. The resulting fraction is then multiplied by the maximum cost improvement score.
(D) The cost improvement score cannot be lower than zero percentage points.
(E) The maximum cost improvement score for the 2020, 2021, 2022, and 2023 MIPS payment years is zero percentage points.
(v) A cost performance category percent score is not calculated if a MIPS eligible clinician or group is not attributed any cost measures for the performance period because the clinician or group has not met the minimum case volume specified by CMS 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) For MIPS eligible clinicians participating in APMs, the improvement activities performance category score is at least 50 percent.
(ii) For MIPS eligible clinicians in a practice that is certified or recognized as a patient-centered medical home or comparable specialty practice, as determined by the Secretary, the improvement activities performance category score is 100 percent. For the 2019 MIPS payment year, at least one practice site within a group's TIN must be certified or recognized as a patient-centered medical home or comparable specialty practice. For the 2020 MIPS payment year and future years, at least 50 percent of the practice sites within a group's TIN must be recognized as a patient-centered medical home or comparable specialty practice. MIPS eligible clinicians that wish to claim this status for purposes of receiving full credit in the improvement activities performance category must attest to their status as a patient-centered medical home or comparable specialty practice in order to receive this credit. A practice is certified or recognized as
(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 practices, and require practices to include the following:
(
(
(
(
(
(4)
(A) A MIPS eligible clinician earns a base score by reporting for each base score measure, as applicable: The numerator (of at least one) and denominator, or a yes/no statement, or an exclusion.
(B) A MIPS eligible clinician earns a performance score by reporting on the performance score measures specified by CMS. A MIPS eligible clinician may earn up to 10 or 20 percentage points as specified by CMS for each performance score measure reported.
(C) A MIPS eligible clinician may earn the following bonus scores:
(
(
(
(ii) For the 2021 and 2022 MIPS payment years, a MIPS eligible clinician's Promoting Interoperability performance category score equals the sum of the scores for each of the six required measures and any applicable bonus scores, not to exceed 100 points.
(A) A MIPS eligible clinician earns a score for each measure by reporting, as applicable: the numerator (of at least one) and denominator, or a yes/no statement. If an exclusion is reported for a measure, the points available for that measure are redistributed to another measure(s).
(B) Each required measure is worth 10, 20, or 40 points, as specified by CMS.
(C) Each optional measure is worth five bonus points.
(c)
(1)
(i) Quality performance category weight is defined under § 414.1330(b).
(ii) Cost performance category weight is defined under § 414.1350(d).
(iii) Improvement activities performance category weight is defined under § 414.1355(b).
(iv) Promoting Interoperability performance category weight is defined under § 414.1375(a).
(2)
(A) CMS determines based on the following circumstances that there are not sufficient measures and activities applicable and available under section 1848(q)(5)(F) of the Act.
(
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(B) Under section 1848(q)(5)(E)(ii) of the Act, CMS estimates that the proportion of MIPS eligible clinicians who are physicians as defined in section 1861(r) of the Act and earn a Promoting Interoperability performance category score of at least 75 percent is 75 percent or greater. The estimation is based on data from the performance period that occurs four years before the MIPS payment year and does not include physicians for whom the Promoting Interoperability performance category is weighted at zero percent.
(C) Under section 1848(o)(2)(D) of the Act, a significant hardship exception or other type of exception is granted to a MIPS eligible clinician based on the following circumstances for the Promoting Interoperability performance category. In the event that a MIPS eligible clinician submits data for the Promoting Interoperability performance category, the scoring weight specified in paragraph (c)(1) of this section will be applied and its weight will not be redistributed.
(
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(ii) A scoring weight different from the weights specified in paragraph (c)(1) of this section will be assigned to a performance category, and its weight as specified in paragraph (c)(1) of this section will be redistributed to another performance category or categories, as follows:
(A) For the 2019 MIPS payment year:
(B) For the 2020 MIPS payment year:
(C) For the 2021 MIPS payment year:
(iii) For MIPS eligible clinicians submitting data as a group or virtual group, in order for the Promoting Interoperability performance category to be reweighted in accordance with paragraph (c)(2)(ii) of this section, all of the MIPS eligible clinicians in the group must qualify for reweighting based on the circumstances described in paragraph (c)(2)(i) of this section.
(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)
(i) The measures used for facility-based measurement are the measure set finalized for the fiscal year value-based purchasing program for which payment begins during the applicable MIPS performance period.
(ii) Beginning with the 2021 MIPS payment year, the scoring methodology applicable for MIPS eligible clinicians scored with facility-based measurement is the Total Performance Score methodology adopted for the Hospital VBP Program, for the fiscal year for which payment begins during the applicable MIPS performance period.
(2)
(i)
(A) Furnishes 75 percent or more of his or her covered professional services in sites of service identified by the place of service codes used in the HIPAA standard transaction as an inpatient hospital, on-campus outpatient hospital, or emergency room setting based on claims for a 12-month segment beginning on October 1 of the calendar year 2 years prior to the applicable performance period and ending on September 30 of the calendar year preceding the performance period with a 30-day claims run out.
(B) Furnishes at least 1 covered professional service in sites of service identified by the place of service codes used in the HIPAA standard transaction as an inpatient hospital, or emergency room setting.
(C) Can be attributed, under the methodology specified in paragraph (e)(5) of this section, to a facility with a value-based purchasing score for the applicable period.
(ii)
(3) [Reserved]
(4)
(5)
(ii) A facility-based group is scored with facility-based measurement using the score derived from the value-based purchasing score for the facility at which the plurality of clinicians identified as facility-based would have had their score determined under paragraph (e)(5)(i) of this section.
(6)
(ii)
(iii)
(iv)
(v)
(A)
(B) [Reserved]
(vi)
(b)
(c)
(a)
(i) A QCDR;
(ii) A qualified registry;
(iii) A health IT vendor; or
(iv) A CMS-approved survey vendor.
(2) QCDRs, qualified registries, and health IT vendors may submit MIPS data for any of the following MIPS performance categories:
(i) Quality, except for data on the CAHPS for MIPS survey;
(ii) Improvement activities; or
(iii) Promoting Interoperability, if the MIPS eligible clinician, group, or virtual group is using CEHRT.
(3) CMS-approved survey vendors may submit data on the CAHPS for MIPS survey for the MIPS quality performance category.
(4) To be approved as a third party intermediary, an entity must agree to meet the applicable requirements of this section, including, but not limited to, the following:
(i) A third party intermediary's principle place of business and retention of any data must be based in the U.S.
(ii) If the data is derived from CEHRT, a QCDR, qualified registry, or health IT vendor must be able to indicate its data source.
(iii) All data must be submitted in the form and manner specified by CMS.
(iv) If the clinician chooses to opt-in in accordance with § 414.1310, the third party intermediary must be able to transmit that decision to CMS.
(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 as true, accurate, and complete to the best of its knowledge. Such certification must be made in a form and manner and at such time as specified by CMS.
(b)
(2)
(ii) If the entity uses an external organization for purposes of data collection, calculation, or transmission, it must have a signed, written agreement with the external organization that specifically details the responsibilities of the entity and the external organization. The written agreement must be effective as of September 1 of the year preceding the applicable performance period.
(3)
(A) Measures that are not included in the MIPS final list of quality measures described in § 414.1330(a)(1) for the applicable MIPS payment year; and
(B) Measures that are included in the MIPS final list of quality measures described in § 414.1330(a)(1) for the applicable MIPS payment year, but have undergone substantive changes, as determined by CMS.
(ii) For the 2020 MIPS payment year and future years, an entity seeking to become a QCDR must submit specifications for each measure, activity, and objective that the entity intends to submit to for MIPS (including the information described in paragraphs (b)(3)(ii)(A) and (B) of this section) at the time of self-nomination. In addition, no later than 15 calendar days following CMS approval of any QCDR measure specifications, the entity must publicly post the measure specifications for each QCDR measure (including the CMS-assigned QCDR measure ID) and provide CMS with a link to where this information is posted.
(A) For QCDR measures, the entity must submit the measure specifications for each QCDR measure, including: 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.
(B) For MIPS quality measures, the entity must submit the MIPS measure IDs and specialty-specific measure sets, as applicable.
(iii) A QCDR must include the CMS-assigned QCDR measure ID when submitting data on any QCDR measure to CMS.
(c)
(2)
(d)
(e)
(1) The entity must have sufficient experience, capability, and capacity to accurately report CAHPS data, including:
(i) At least 3 years of experience administering mixed-mode surveys (that is, surveys that employ multiple modes to collect date), including mail survey administration followed by survey administration via Computer Assisted Telephone Interview (CATI);
(ii) At least 3 years of experience administering surveys to a Medicare population;
(iii) At least 3 years of experience administering CAHPS surveys within the past 5 years;
(iv) Experience administering surveys in English and at least one other language for which a translation of the CAHPS for MIPS survey is available;
(v) Use equipment, software, computer programs, systems, and facilities that can verify addresses and phone numbers of sampled beneficiaries, monitor interviewers, collect data via CATI, electronically administer the survey and schedule call-backs to beneficiaries at varying times of the day and week, track fielded surveys, assign final disposition codes to reflect the outcome of data collection of each sampled case, and track cases from mail surveys through telephone follow-up activities; and
(vi) Employment of a program manager, information systems specialist, call center supervisor and mail center supervisor to administer the survey.
(2) The entity has certified that it has the ability to maintain and transmit quality data in a manner that preserves the security and integrity of the data.
(3) The entity has successfully completed, and has required its subcontractors to successfully complete, vendor training(s) administered by CMS or its contractors.
(4) The entity has submitted a quality assurance plan and other materials relevant to survey administration, as determined by CMS, including cover letters, questionnaires and telephone scripts.
(5) The entity has agreed to participate and cooperate, and has required its subcontractors to participate and cooperate, in all oversight activities related to survey administration conducted by CMS or its contractors.
(6) The entity has sent an interim survey data file to CMS that establishes the entity's ability to accurately report CAHPS data.
(f)
(i) Require the third party intermediary to submit a corrective action plan (CAP) to CMS to address the identified deficiencies or data issue, including the actions it will take to prevent the deficiencies or data issues from recurring. The CAP must be submitted to CMS by a date specified by CMS.
(ii) Publicly disclose the entity's data error rate on the CMS website until the data error rate falls below 3 percent.
(2) CMS may immediately or with advance notice terminate the ability of a third party intermediary to submit MIPS data on behalf of a MIPS eligible clinician, group, or virtual group for one or more of the following reasons:
(i) CMS has grounds to impose remedial action;
(ii) CMS has not received a CAP within the specified time period or the CAP is not accepted by CMS; or
(iii) The third party intermediary fails to correct the deficiencies or data errors by the date specified by CMS.
(3) For purposes of paragraph (f) of this section, CMS may determine that submitted data is inaccurate, unusable, or otherwise compromised if the submitted data:
(i) Includes, without limitation, TIN/NPI mismatches, formatting issues, calculation errors, or data audit discrepancies; and
(ii) Affects more than 3 percent of the total number of MIPS eligible clinicians or group for which data was submitted by the third party intermediary.
(g)
(1) The entity must make available to CMS the contact information of each MIPS eligible clinician or group on behalf of whom it submits data. The contact information must include, at a minimum, the MIPS eligible clinician or group's practice phone number, address, and, if available, email.
(2) The entity must retain all data submitted to CMS for 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.
The additions and revision read as follows:
(b) * * *
(6) The performance threshold for the 2021 MIPS payment year is 30 points.
(d) * * *
(5) The additional performance threshold for the 2021 MIPS payment year is 75 points.
(e)
(f)
(1) Are made only to participants in a model tested under section 1115A of the Act;
(2) Would otherwise be subject to the requirement to apply the MIPS payment adjustment factors if the payment is made with respect to a MIPS eligible clinician participating in a section 1115A model; and
(3) Either have a specified payment amount or are paid according to a methodology for calculating a model-specific payment that is applied in a consistent manner to all model participants, such that application of the MIPS payment adjustment factors would potentially interfere with CMS's ability to effectively evaluate the impact of the APM.
(a) * * *
(1) * * *
(i) Require at least 50 percent, or for QP Performance Periods beginning in 2019, 75 percent of eligible clinicians in each participating APM Entity group, or for APMs in which hospitals are the APM Entities, each hospital, to use CEHRT to document and communicate clinical care to their patients or health care providers; or
(ii) For QP Performance Periods prior to 2019, for the Shared Savings Program, apply a penalty or reward to an APM Entity based on the degree of the use of CEHRT of the eligible clinicians in the APM Entity.
(b) * * *
(1) To be an Advanced APM, an APM must include quality measure performance as a factor when determining payment to participants for covered professional services under the terms of the APM.
(c)
(3) * * *
(i) * * *
(A) For QP Performance Periods beginning in 2017, through 2024, 8 percent of the average estimated total Medicare Parts A and B revenue of all providers and suppliers in participating APM Entities; or
(6)
(b) * * *
(2) At least one of the quality measures used in the payment arrangement as specified in paragraph (b)(1) of this section must:
(i) For QP Performance Periods before January 1, 2020, have an evidence-based focus, be reliable and valid, and meet at least one of the following criteria:
(A) Used in the MIPS quality performance category, as described in § 414.1330;
(B) Endorsed by a consensus-based entity;
(C) Developed under section 1848(s) of the Act;
(D) Submitted in response to the MIPS Call for Quality Measures under section 1848(q)(2)(D)(ii) of the Act; or
(E) Any other quality measures that CMS determines to have an evidence-based focus and to be reliable and valid; and
(ii) For QP Performance Periods beginning on or after January1, 2020, be:
(A) Finalized on the MIPS final list of measures, as described in § 414.1330;
(B) Endorsed by a consensus-based entity; or
(C) Determined by CMS to be evidenced-based, reliable, and valid.
(3) In addition to the quality measure described under paragraph (b)(2) of this section, the quality measures upon which an Advanced APM bases the payment in paragraph (b)(1) of this section must include at least one additional measure that is an outcome measure unless CMS determines that there are no available or applicable outcome measures included in the MIPS final quality measures list for the Advanced APM's first QP Performance Period. Beginning January 1, 2020, the included outcome measure must satisfy the criteria in paragraph (b)(2) of this section.
(d)
(3) * * *
(i) For QP Performance Periods 2019 through 2024, 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, 3 percent of the expected expenditures for which an APM Entity is responsible under the payment arrangement.
(7)
(b)
(c) * * *
(2) At least one of the quality measures used in the payment arrangement as specified in paragraph (c)(1) of this section must:
(i) For QP Performance Period before January 1, 2020, have an evidence-based focus, be reliable and valid, and meet at least one of the following criteria:
(A) Used in the MIPS quality performance category, as described in § 414.1330;
(B) Endorsed by a consensus-based entity;
(C) Developed under section 1848(s) of the Act;
(D) Submitted in response to the MIPS Call for Quality Measures under section 1848(q)(2)(D)(ii) of the Act; or
(E) Any other quality measures that CMS determines to have an evidence-based focus and to be reliable and valid; and
(ii) For QP Performance Periods beginning on or after January 1, 2020, be:
(A) Finalized on the MIPS final list of measures, as described in § 414.1330;
(B) Endorsed by a consensus-based entity; or
(C) Determined by CMS to be evidenced-based, reliable, and valid.
(3) To meet the quality measure use criterion under paragraph (c)(1) of this section, a payment arrangement must:
(i) For QP Performance Periods before January 1, 2020, use an outcome measure if there is an applicable outcome measure on the MIPS quality measure list. This criterion also applies for payment arrangements determined to be Other Payer Advanced APMs on or before January 1, 2020, but only for the Other Payer Advanced APM determination made with respect to the arrangement for the CY 2020 QP Performance Period (regardless of whether that determination is a single- or multi-year determination).
(ii) For QP Performance Periods on or after January 1, 2020, in addition to the quality measure described under paragraph (c)(2) of this section, use at least one additional measure that is an outcome measure and meets the criteria in paragraph (c)(2)(ii) of this section if there is such an applicable outcome measure on the MIPS quality measure list.
(d) * * *
(1) CMS performs QP determinations following the QP Performance Period using payment amount and/or patient count information submitted from January 1 through each of the respective QP determination dates: March 31, June 30, and August 31. CMS will use data for the same time periods for the Medicare and other payer portions of Threshold Score calculations under the All-Payer Combination Option. CMS will use the payment amount or patient count method, applying the more advantageous of the two for both the Medicare and other payer portions of the Threshold score calculation, regardless of the method used for the Medicare Threshold Score calculation.
(2) An APM Entity may request that CMS make QP determinations at the APM Entity level, an eligible clinician may request that CMS make QP determinations at the eligible clinician level, and an eligible clinician or an APM Entity may request that CMS makes QP determinations at the TIN-level in instances where all clinicians who reassigned billing rights to the TIN are participating in a single APM Entity. CMS makes QP determinations at either the APM Entity, eligible clinician, or TIN 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. Eligible Clinicians may meet the Medicare and the All-Payer Combination Option thresholds using the payment amount method for both thresholds, the patient account method for both thresholds, or the payment amount method for one threshold and the patient account method for the other threshold.
(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 or, at the TIN level when all clinicians who have reassigned billing rights to the TIN are included in a single APM Entity; and if the Medicare Threshold score for the APM Entity group is higher than when calculated for the eligible clinician or TIN, CMS makes QP determinations using a weighted Medicare Threshold Score that is factored into an All-Payer Combination Option Threshold Score.
(b) * * *
(1)
(c) * * *
(2) * * *
(i) Based on the submission by an eligible clinician or payer of evidence that CMS determines sufficiently demonstrates that CEHRT is used as specified in § 414.1420(b) by participants in the payment arrangement, CMS will consider the CEHRT criterion in § 414.1420(b) is satisfied for that payment arrangement.
(ii) [Reserved]
42 U.S.C. 1302 and 1395hh.
(b)
The addition reads as follows:
(a) * * *
(6) The medical records must document the extent of the teaching physician's participation in the review and direction of services furnished to each beneficiary. The extent of the teaching physician's participation may be demonstrated by the notes in the medical records made by a physician, resident, or nurse.
42 U.S.C. 1302, 1306, 1395hh, and 1395jjj.
The revisions and additions read as follows:
The revisions and additions read as follows:
(a)
(b)
(2)
(ii) The term of the participation agreement is 3 years unless all of the following conditions are met to extend the participation agreement by 6 months:
(A) The ACO entered an agreement period starting on January 1, 2016.
(B) The ACO elects to extend its agreement period until June 30, 2019.
(
(
(3)
(c)
(1) For an ACO with a start date of April 1, 2012, or July 1, 2012, the ACO's first performance year is defined as 21 months or 18 months, respectively.
(2) For an ACO that entered a first or second agreement period with a start date of January 1, 2016, and that elects to extend its agreement period by a 6-month period under paragraph (b)(2)(ii)(B) of this section, the ACO's fourth performance year is the 6-month period between January 1, 2019, and June 30, 2019.
(d)
The addition reads as follows:
(a) * * *
(3) * * *
(iii) That the percentage of eligible clinicians participating in the ACO that use CEHRT to document and communicate clinical care to their patients or other health care providers meets or exceeds the applicable percentage specified by CMS at § 425.506(f).
The revisions and additions read as follows:
(a)(1) * * *
(ii) CMS applies a step-wise process based on the beneficiary's utilization of primary care services provided under Title XVIII by a physician who is an ACO professional during each performance year for which shared savings are to be determined and, with respect to ACOs participating in a 6-month performance year during CY 2019, during the entirety of CY 2019 as specified in § 425.609.
(c) * * *
(1) * * *
(iv) For performance years starting on January 1, 2019, and subsequent performance years as follows:
(A) CPT codes:
(
(
(
(
(
(
(
(
(
(
(B) HCPCS codes:
(
(
(
(b) A beneficiary is excluded from the prospective assignment list of an ACO that is participating under prospective assignment under § 425.400(a)(3) at the end of a performance or benchmark year and quarterly during each performance year consistent with § 425.400(a)(3)(ii), or at the end of CY 2019 as specified in § 425.609(b)(1)(ii), if the beneficiary meets any of the following criteria during the performance or benchmark year:
(e) * * *
(2) Beneficiaries are added to the ACO's list of assigned beneficiaries if all of the following conditions are satisfied:
(i) For performance year 2018:
(A) The beneficiary must have had at least one primary care service during the assignment window as defined under § 425.20 with a physician who is an ACO professional in the ACO who is a primary care physician as defined under § 425.20 or who has one of the primary specialty designations included in paragraph (c) of this section.
(B) The beneficiary meets the eligibility criteria established at § 425.401(a) and must not be excluded by the criteria at § 425.401(b). The exclusion criteria at § 425.401(b) apply for purposes of determining beneficiary eligibility for alignment to ACOs under all tracks based on the beneficiary's designation of an ACO professional as responsible for coordinating their overall care under paragraph (e) of this section.
(C) The beneficiary must have designated an ACO professional who is a primary care physician as defined at § 425.20, a physician with a specialty designation included at paragraph (c) of this section, or a nurse practitioner, physician assistant, or clinical nurse specialist as responsible for coordinating their overall care.
(D) If a beneficiary has designated a provider or supplier outside the ACO who is a primary care physician as defined at § 425.20, a physician with a specialty designation included at paragraph (c) of this section, or a nurse practitioner, physician assistant, or clinical nurse specialist, as responsible for coordinating their overall care, the beneficiary is not added to the ACO's list of assigned beneficiaries under the assignment methodology in paragraph (b) of this section.
(ii) For performance years starting on January 1, 2019, and subsequent performance years:
(A) The beneficiary meets the eligibility criteria established at § 425.401(a) and must not be excluded by the criteria at § 425.401(b). The exclusion criteria at § 425.401(b) apply for purposes of determining beneficiary eligibility for alignment to an ACO based on the beneficiary's designation of an ACO professional as responsible for coordinating their overall care under paragraph (e) of this section, regardless of the ACO's assignment methodology selection under § 425.400(a)(4)(ii).
(B) The beneficiary must have designated an ACO professional as responsible for coordinating their overall care.
(C) If a beneficiary has designated a provider or supplier outside the ACO as responsible for coordinating their overall care, the beneficiary is not added under the assignment methodology in paragraph (b) of this section to the ACO's list of assigned beneficiaries for a 12-month performance year or the ACO's list of assigned beneficiaries for a 6-month performance year, which is based on the entire CY 2019 as provided in § 425.609.
(D) The beneficiary is not assigned to an entity participating in a model tested or expanded under section 1115A of the Act under which claims-based assignment is based solely on claims for services other than primary care services and for which there has been a determination by the Secretary that waiver of the requirement in section 1899(c)(2)(B) of the Act is necessary solely for purposes of testing the model.
The revisions and additions read as follows:
(e) * * *
(4) * * *
(vii) For performance year 2017 and subsequent performance years, if an ACO receives the mean Shared Savings Program ACO quality score under paragraph (f) of this section, in the next performance year for which the ACO receives a quality performance score based on its own quality reporting, quality improvement is measured based on a comparison between the performance in that year and the most recently available prior performance year in which the ACO reported quality.
(f)
(1) CMS determines the ACO was affected by an extreme and uncontrollable circumstance based on either of the following:
(i) Twenty percent or more of the ACO's assigned beneficiaries reside in an area identified under the Quality Payment Program as being affected by an extreme and uncontrollable circumstance.
(A) Assignment is determined under subpart E of this part.
(B) In making this determination for performance year 2017, CMS uses the final list of beneficiaries assigned to the ACO for the performance year. For performance year 2018 and subsequent performance years, CMS uses the list of assigned beneficiaries used to generate the Web Interface quality reporting sample.
(ii) The ACO's legal entity is located in an area identified under the Quality Payment Program as being affected by an extreme and uncontrollable circumstance. An ACO's legal entity location is based on the address on file for the ACO in CMS' ACO application and management system.
(2) If CMS determines the ACO meets the requirements of paragraph (f)(1) of this section, CMS calculates the ACO's quality score as follows:
The addition reads as follows:
(f) For performance years starting on January 1, 2019, and subsequent performance years, ACOs in a track that—
(1) Does not meet the financial risk standard to be an Advanced APM must certify annually that the percentage of eligible clinicians participating in the ACO that use CEHRT to document and communicate clinical care to their patients or other health care providers meets or exceeds 50 percent; or
(2) Meets the financial risk standard to be an Advanced APM must certify annually that the percentage of eligible clinicians participating in the ACO that use CEHRT to document and communicate clinical care to their patients or other health care providers meets or exceeds the threshold established under § 414.1415(a)(1)(i) of this chapter.
(c)
(1) When adjusting the benchmark using the methodology set forth in paragraph (a)(9) of this section and § 425.609(b), CMS adjusts for severity and case mix between BY3 and CY 2019.
(2) When updating the benchmark using the methodology set forth in paragraph (b) of this section and § 425.609(b), CMS updates the benchmark based on growth between BY3 and CY 2019.
(g) In determining performance for the January 1, 2019 through June 30, 2019 performance year described in § 425.609(b) CMS does all of the following:
(1) When adjusting the benchmark using the methodology set forth in paragraph (c)(10) of this section and § 425.609(b), CMS adjusts for severity and case mix between BY3 and CY 2019.
(2) When updating the benchmark using the methodology set forth in paragraph (d) of this section and § 425.609(b), CMS updates the benchmark based on growth between BY3 and CY 2019.
(g)
The addition reads as follows:
(j)
(a)
(b)
(1) Uses the ACO participant list in effect for the performance year beginning January 1, 2019, to determine beneficiary assignment, using claims for the entire calendar year, as specified in §§ 425.402 and 425.404, and according to the ACO's track as specified in § 425.400.
(i) For ACOs under preliminary prospective assignment with retrospective reconciliation the assignment window is CY 2019.
(ii) For ACOs under prospective assignment—
(A) Medicare fee-for-service beneficiaries are prospectively assigned to the ACO based on the beneficiary's use of primary care services in the most recent 12 months for which data are available; and
(B) Beneficiaries remain prospectively assigned to the ACO at the end of CY 2019 if they do not meet any of the exclusion criteria under § 425.401(b) during the calendar year.
(2) Uses the ACO's quality performance for the 2019 reporting period to determine the ACO's quality performance score as specified in § 425.502. The ACO's latest certified ACO participant list is used to determine the quality reporting samples for the 2019 reporting year for an ACO that extends its participation agreement for the 6-month performance year from January 1, 2019, through June 30, 2019, under § 425.200(b)(2)(ii)(B).
(3) Uses the methodology for calculating shared savings or shared losses applicable to the ACO under the terms of the participation agreement that was in effect on January 1, 2019.
(i) The ACO's historical benchmark is determined according to either § 425.602 (first agreement period) or § 425.603 (second agreement period) except as follows:
(A) The benchmark is adjusted for changes in severity and case mix between BY3 and CY 2019 using the methodology that accounts separately for newly and continuously assigned beneficiaries using prospective HCC risk scores and demographic factors as described under §§ 425.604(a)(1) through (3), 425.606(a)(1) through (3), and 425.610(a)(1) through (3).
(B) The benchmark is updated to CY 2019 according to the methodology described under § 425.602(b), § 425.603(b), or § 425.603(d), based on whether the ACO is in its first or second agreement period, and for an ACO in a second agreement period, the date on which that agreement period began.
(ii) The ACO's financial performance is determined based on the track the ACO is participating under during the performance year starting on January 1, 2019 (§ 425.604, § 425.606 or § 425.610), unless otherwise specified. In determining ACO financial performance, CMS does all of the following:
(A) Average per capita Medicare Parts A and B fee-for-service expenditures for CY 2019 are calculated for the ACO's performance year assigned beneficiary population identified in paragraph (b)(1) of this section.
(B) Expenditures calculated in paragraph (b)(3)(ii)(A) of this section are compared to the ACO's updated benchmark determined according to paragraph (b)(3)(i) of this section.
(C)(
(
(
(
(
(
(D) For an ACO that meets all the requirements to receive a shared savings payment under paragraph (b)(3)(ii)(C)(
(
(
(E) For an ACO responsible for shared losses under paragraph (b)(3)(ii)(C)(
(
(
(c) [Reserved]
(d)
(1) In calculating the amount of shared losses owed, CMS makes adjustments to the amount determined in paragraph (b)(3)(ii)(E)(
(2) In determining the ACO's quality performance score for the 2019 quality reporting period, CMS uses the alternative scoring methodology specified in § 425.502(f).
(e)
(1) CMS notifies an ACO in writing regarding whether the ACO qualifies for a shared savings payment, and if so, the amount of the payment due.
(2) CMS provides written notification to an ACO of the amount of shared losses, if any, that it must repay to the program.
(3) If an ACO has shared losses, the ACO must make payment in full to CMS within 90 days of receipt of notification.
The addition reads as follows:
(j)
(d) For an ACO eligible to be reconciled under § 425.609(b), CMS shares with the ACO quarterly aggregate reports as provided in paragraphs (b) and (c)(1)(ii) of this section for CY 2019.
42 U.S.C. 1302 and 1395hh.
(1) * * *
(v) Under the Medicaid Promoting Interoperability Program, for the CY 2021 payment year:
(A) For the EP first demonstrating he or she is a meaningful EHR user, any continuous 90-day period within CY 2021 that ends before October 31, 2021, or that ends before an earlier date in CY 2021 that is specified by the state and approved by CMS in the State Medicaid HIT plan described at § 495.332.
(B) For the EP who has successfully demonstrated he or she is a meaningful EHR user in any prior year, any continuous 90-day period within CY 2021 that ends before October 31, 2021, or that ends before an earlier date in CY 2021 that is specified by the state and approved by CMS in the State Medicaid HIT plan described at § 495.332.
(d) * * *
(6) * * *
(i) * * *
(B)
(
(
(
(
(
(
(8) * * *
(i) * * *
(B) * * *
(
(f) * * *
(3) An alternative date within CY 2021 by which all “EHR reporting periods” (as defined under § 495.4) for the CY 2021 payment year for Medicaid EPs demonstrating they are meaningful EHR users must end. The alternative date selected by the state must be earlier than October 31, 2021, and must not be any earlier than the day prior to the attestation deadline for Medicaid EPs attesting to that state.
(4) An alternative date within CY 2021 by which all clinical quality measure reporting periods for the CY 2021 payment year for Medicaid EPs demonstrating they are meaningful EHR users must end. The alternative date selected by the state must be earlier than October 31, 2021, and must not be any earlier than the day prior to the attestation deadline for Medicaid EPs attesting to that state.
(5) For the CY 2019 payment year and beyond, a state-specific listing of which clinical quality measures selected by CMS are considered to be high priority measures for purposes of Medicaid EP clinical quality measure reporting.
Except as otherwise finalized in this final rule, previously finalized measures and specialty measure sets will continue to apply for the 2021 MIPS payment year and future years.
Notice is hereby given pursuant to the Antitrust Procedures and Penalties Act, 15 U.S.C. § 16(b)-(h), that proposed Final Judgments, Stipulations, and a Competitive Impact Statement have been filed with the United States District Court for the Southern District of Ohio in
Copies of the Complaint, proposed Final Judgments, and Competitive Impact Statement are available for inspection on the Antitrust Division's website at
Public comment is invited within 60 days of the date of this notice. Such comments, including the name of the submitter, and responses thereto, will be posted on the Antitrust Division's website, filed with the Court, and, under certain circumstances, published in the
The United States of America, acting under the direction of the Acting Attorney General of the United States, brings this civil antitrust action to obtain equitable monetary relief and recover damages from GS Caltex Corporation, Hanjin Transportation Co., Ltd., and SK Energy Co., Ltd., for conspiring to rig bids and fix prices, in violation of Section 1 of the Sherman Act, 15 U.S.C. § 1, on the supply of fuel to the U.S. military for its operations in South Korea.
1. Since the end of the Korean War, the U.S. armed forces have maintained a significant presence in South Korea, protecting American interests in the region and safeguarding peace for the Korean people. To perform this important mission, American service members depend on fuel to power their bases and military vehicles. The U.S. military procures this fuel from oil refiners located in South Korea through a competitive bidding process.
2. For at least a decade, rather than engage in fair and honest competition, Defendants and their co-conspirators defrauded the U.S. military by fixing prices and rigging bids for the contracts to supply this fuel. Defendants met and communicated in secret with other large South Korean oil refiners and logistics companies, and pre-determined which conspirator would win each contract. Defendants and their co-conspirators then fraudulently submitted collusive bids to the U.S. military. Through this scheme, Defendants reaped vastly higher profit margins on the fuel they supplied to the U.S. military than on the fuel they sold to the South Korean military and to private parties.
3. As a result of this conduct, Defendants and their co-conspirators illegally overcharged American taxpayers by well over $100 million. This conspiracy unreasonably restrained trade and commerce, in violation of Section 1 of the Sherman Act, 15 U.S.C. § 1. Defendants have agreed to plead guilty to an information charging a criminal violation of Section 1 of the Sherman Act for this unlawful conduct, and in this civil action, the United States seeks compensation for the injuries it incurred as a result of this conspiracy.
4. GS Caltex Corporation (“GS Caltex”) is an oil company headquartered in Seoul, South Korea. GS Caltex is a joint venture between GS Energy, a South Korean corporation, and Chevron Corp., a Delaware corporation; each owns a 50 percent interest in GS Caltex. GS Caltex refines and supplies gasoline, diesel, kerosene, and other petroleum products for sale internationally. During the conspiracy, GS Caltex supplied fuel to U.S. military installations in South Korea.
5. Hanjin Transportation Co., Ltd. (“Hanjin”) is a global transportation and logistics company based in Seoul, South Korea. Hanjin is a member of Hanjin Group, a South Korean conglomerate with U.S. subsidiaries, including Hanjin International America. Beginning in 2009, Hanjin partnered with oil companies, including a co-conspirator oil company (“Company A”), to supply fuel to U.S. military installations in South Korea.
6. SK Energy Co., Ltd. (“SK Energy”) is an oil company headquartered in Seoul, South Korea. SK Energy is a wholly-owned subsidiary of SK Innovation Co., Ltd., a South Korean company with U.S. subsidiaries, including SK Energy Americas Inc. SK Energy refines and supplies gasoline, diesel, kerosene, and other petroleum products for sale internationally. During the conspiracy, SK Energy supplied fuel to U.S. military installations in South Korea.
7. Other persons, not named as defendants in this action, participated as co-conspirators in the offense alleged in this Complaint and performed acts and made statements in furtherance thereof. These co-conspirators include, among others, a logistics firm (“Company B”) and an oil company (“Company C”) that jointly supplied fuel to the U.S. military.
8. Whenever this Complaint refers to any act, deed, or transaction of any
9. The United States brings this action under Section 4 of the Sherman Act, 15 U.S.C. § 4, and Section 4A of the Clayton Act, 15 U.S.C. § 15a, seeking equitable relief, including equitable monetary remedies, and damages from Defendants' violation of Section 1 of the Sherman Act, 15 U.S.C. § 1.
10. This Court has subject matter jurisdiction over this action under 15 U.S.C. §§ 4 and 15a and 28 U.S.C. §§ 1331 and 1337.
11. Defendants have consented to venue and personal jurisdiction in this district for the purpose of this Complaint.
12. Defendants entered into contracts with the U.S. military to supply and deliver fuel to U.S. military installations in South Korea. Under the terms of these contracts, Defendants agreed that the laws of the United States would govern all contractual disputes and that U.S. administrative bodies and courts would have exclusive jurisdiction to resolve all such disputes. To be eligible to enter into these contracts, Defendants registered in databases located in the United States. For certain contracts, Defendants submitted bids to U.S. Department of Defense offices in the United States. After being awarded these contracts, Defendants submitted invoices to and received payments from U.S. Department of Defense offices in Columbus, Ohio, which included use of wires and mails located in the United States.
13. Through its contracts with the U.S. military, Defendants' activities had a direct, substantial, and reasonably foreseeable effect on interstate commerce, import trade or commerce, and commerce with foreign nations. Defendants' conspiracy had a substantial and intended effect in the United States. Defendants caused U.S. Department of Defense agencies to pay non-competitive prices for the supply of fuel to U.S. military installations. Defendants also caused a U.S. Department of Defense agency located in the Southern District of Ohio to transfer U.S. dollars to their foreign bank accounts.
14. From at least March 2005 and continuing until at least October 2016 (“the Relevant Period”), the U.S. military procured fuel for its installations in South Korea through competitive solicitation processes. Oil companies, either independently or in conjunction with a logistics company, submitted bids in response to these solicitations.
15. The conduct at issue relates to two types of contracts to supply fuel to the U.S. military for use in South Korea: Post, Camps, and Stations (“PC&S”) contracts and Army and Air Force Exchange Services (“AAFES”) contracts.
16. PC&S contracts are issued and administered by the Defense Logistics Agency (“DLA”), a combat support agency in the U.S. Department of Defense. DLA, formerly known as the Defense Energy Support Center, is headquartered in Fort Belvoir, Virginia. The fuel procured under PC&S contracts is used for military vehicles and to heat U.S. military buildings. During the Relevant Period, PC&S contracts ran for a term of three or four years. DLA issued PC&S solicitations listing the fuel requirements for installations across South Korea, with each delivery location identified by a separate line item. Bidders offered a price for each line item on which they chose to bid. DLA awarded contracts to the bidders offering the lowest price for each line item. The Defense Finance and Accounting Service (“DFAS”), a finance and accounting agency of the U.S. Department of Defense, wired payments to the PC&S contract awardees from its office in Columbus, Ohio.
17. AAFES is an agency of the Department of Defense headquartered in Dallas, Texas. AAFES operates official retail stores (known as “exchanges”) on U.S. Army and Air Force installations worldwide, which U.S. military personnel and their families use to purchase everyday goods and services, including gasoline for use in their personal vehicles. AAFES procures fuel for these stores via contracts awarded through a competitive solicitation process. The term of AAFES contracts is typically two years, but may be extended for additional years. In 2008, AAFES issued a solicitation that listed the fuel requirements for installations in South Korea. Unlike DLA, AAFES awarded the entire 2008 contract to the bidder offering the lowest price across all the listed locations.
18. From at least March 2005 and continuing until at least October 2016, Defendants and their co-conspirators engaged in a series of meetings, telephone conversations, e-mails, and other communications to rig bids and fix prices for the supply of fuel to U.S. military installations in South Korea.
19. GS Caltex, SK Energy, and Companies B and C conspired to rig bids and fix prices on the 2006 PC&S contracts, which were issued in response to solicitation SP0600-05-R-0063, supplemental solicitation SP0600-05-0063-0001, and their amendments. The term of the 2006 PC&S contracts covered the supply of fuel from February 2006 through July 2009.
20. Between early 2005 and mid-2006, GS Caltex, SK Energy, and other conspirators met multiple times and exchanged phone calls and e-mails to allocate the line items in the solicitations for the 2006 PC&S contracts. For each line item allocated to a different co-conspirator, the other conspirators agreed not to bid or to bid high enough to ensure that they would not win that item. Through these communications, these conspirators agreed to inflate their bids to produce higher profit margins. DLA awarded the 2006 PC&S line items according to the allocations made by the conspiracy.
21. As part of their discussions related to the 2006 PC&S contracts, GS Caltex and other conspirators agreed not to compete with SK Energy in bidding for the 2008 AAFES contract. In 2008, GS Caltex and other conspirators honored their agreement: GS Caltex bid significantly above the bid submitted by SK Energy for the AAFES contract, while Companies B and C declined to bid even after AAFES explicitly requested their participation in the bidding. The initial term of the 2008 AAFES contract ran from July 2008 to July 2010; the contract was later extended through July 2013. As envisioned by the conspiracy, AAFES awarded the 2008 contract to SK Energy.
22. Continuing their conspiracy, Defendants and other co-conspirators conspired to rig bids and fix prices for the 2009 PC&S contracts, which were issued in response to solicitation SP0600-08-R-0233. Hanjin and Company A joined the conspiracy for the purpose of bidding on the solicitation for the 2009 PC&S contracts. Hanjin and Company A partnered to bid jointly on the 2009 PC&S contracts, with Company A providing the fuel and Hanjin providing transportation and logistics. The term of the 2009 PC&S contracts covered the supply of fuel from October 2009 through August 2013.
23. Between late 2008 and mid-2009, Defendants and other co-conspirators met multiple times and exchanged phone calls and e-mails to allocate the line items in the solicitation for the 2009 PC&S contracts. As in 2006, these conspirators agreed to bid high so as to not win line items allocated to other co-conspirators. The original conspirators agreed to allocate to Hanjin and Company A certain line items that had previously been allocated to the original conspirators.
24. With one exception, DLA awarded the 2009 PC&S contracts in line with the allocations made by the Defendants and other co-conspirators. Companies B and C accidentally won one line item that the conspiracy had allocated to GS Caltex. To remedy this misallocation, Company B and GS Caltex agreed that GS Caltex, rather than Company C, would supply Company B with the fuel procured under this line item.
25. Similar to 2006 and 2009, Defendants and other co-conspirators conspired to rig bids and fix prices for the 2013 PC&S contracts, which were issued in response to solicitation SP0600-12-R-0332. The term of the 2013 PC&S Contract covered the supply of fuel from August 2013 through July 2016.
26. Defendants and other co-conspirators communicated via phone calls and e-mails to allocate and set the price for each line item in the solicitation for the 2013 PC&S contracts. Defendants and other co-conspirators believed that they had an agreement as to their bidding strategy and pricing for the 2013 PC&S contracts. As a result of this agreement, they bid higher prices than they would have in a competitive process.
27. However, Hanjin and Company A submitted bids for the 2013 PC&S contracts below the prices set by the other co-conspirators. Although lower than the pricing agreed upon by the conspirators, Hanjin and Company A still submitted bids above a competitive, non-collusive price, knowing that they would likely win the contracts because the other conspirators would bid even higher prices.
28. As a result of their bidding strategy, Hanjin and Company A jointly won nearly all the line items in the 2013 PC&S contracts. As in 2009, Company A was to provide the fuel for these line items, and Hanjin was to provide transportation and logistics. GS Caltex and other co-conspirators won a few, small line items; SK Energy won none. DLA made inflated payments under the 2013 PC&S contracts through October 2016.
29. After the award of the 2013 PC&S contracts, Hanjin, Company A, and GS Caltex reached an understanding that GS Caltex, rather than Company A, would supply Hanjin with fuel for certain line items. Under this side agreement, Hanjin paid a much lower price to GS Caltex for fuel than the price it previously had agreed to pay Company A to acquire fuel for those line items. However, the price that Hanjin paid to GS Caltex exceeded a competitive price for fuel.
30. The United States incorporates by reference the allegations in paragraphs 1 through 29.
31. The conduct of Defendants and their co-conspirators unreasonably restrained trade and harmed competition for the supply of fuel to the U.S. military in South Korea in violation of Section 1 of the Sherman Act, 15 U.S.C. § 1.
32. The United States was injured as a result of the unlawful conduct because it paid more for the supply of fuel than it would have had the Defendants and their co-conspirators engaged in fair competition.
33. The United States requests that this Court:
(a) adjudge that Defendants' and their co-conspirators' conduct constitutes an unreasonable restraint of interstate commerce, import trade or commerce, and commerce with foreign nations in violation of Section 1 of the Sherman Act, 15 U.S.C. § 1;
(b) award the United States damages to which it is entitled for the losses incurred as the result of Defendants' and their co-conspirators' conduct;
(c) award the United States equitable disgorgement of the ill-gotten gains obtained by Defendants;
(d) award the United States its costs of this action; and
(e) award the United States other relief that the Court deems just and proper.
WHEREAS Plaintiff, United States of America, filed its Complaint on November 14, 2018, the United States and Defendant GS Caltex Corporation (“GS Caltex”), by their respective attorneys, have consented to the entry of this Final Judgment without trial or adjudication of any issue of fact or law;
WHEREAS, on such date as may be determined by the Court, GS Caltex will plead guilty pursuant to Fed. R. Crim. P. 11(c)(1)(C) (the “Plea Agreement”) to an Information to be filed in
WHEREAS, this Final Judgment does not constitute any evidence against or admission by any party regarding any issue of fact or law;
NOW, THEREFORE, before the taking of any testimony and without trial or final adjudication of any issue of fact or law herein, and upon consent of the parties hereto, it is hereby ORDERED, ADJUDGED, AND DECREED:
This Court has jurisdiction of the subject matter of this action and each of the parties consenting hereto. The Complaint states a claim upon which relief may be granted to the United States against GS Caltex under Section 1 of the Sherman Act, 15 U.S.C. § 1.
This Final Judgment applies to GS Caltex, as defined above, and all other persons in active concert or participation with any of them who receive actual notice of this Final Judgment by personal service or otherwise.
GS Caltex shall pay to the United States within ten (10) business days of the entry of this Final Judgment the amount of fifty-seven million, five hundred thousand dollars ($57,500,000), less the amount paid (excluding any interest) pursuant to the settlement agreement attached hereto as Attachment 1, to satisfy all civil antitrust claims alleged against GS Caltex by the United States in the Complaint. Payment of the amount ordered hereby shall be made by wire transfer of funds or cashier's check. If the payment is made by wire transfer, GS Caltex shall contact Janie Ingalls of the Antitrust Division's Antitrust Documents Group at (202) 514-2481 for instructions before making the transfer. If the payment is made by cashier's check, the check shall be made payable to the United States Department of Justice and delivered to: Janie Ingalls, United States Department of Justice Antitrust Division, Antitrust Documents Group, 450 5th Street, NW, Suite 1024, Washington, D.C. 20530. In the event of a default in payment, interest at the rate of eighteen (18) percent per annum shall accrue thereon from the date of default to the date of payment.
GS Caltex shall cooperate fully with the United States regarding any matter about which GS Caltex has knowledge or information relating to any ongoing civil investigation, litigation, or other proceeding arising out of any ongoing federal investigation of the subject matter discussed in the Complaint (hereinafter, any such investigation, litigation, or proceeding shall be referred to as a “Civil Federal Proceeding”).
The United States agrees that any cooperation provided in connection with the Plea Agreement and/or pursuant to the settlement agreement attached hereto as Attachment 1 will be considered cooperation for purposes of this Final Judgment, and the United States will use its reasonable best efforts, where appropriate, to coordinate any requests for cooperation in connection with the Civil Federal Proceeding with requests for cooperation in connection with the Plea Agreement and the settlement agreement attached hereto as Attachment 1, so as to avoid unnecessary duplication and expense.
GS Caltex's cooperation shall include, but not be limited to, the following:
(a) Upon request, completely and truthfully disclosing and producing, to the offices of the United States and at no expense to the United States, copies of all non-privileged information, documents, materials, and records in its possession (and for any foreign-language information, documents, materials, or records, copies must be produced with an English translation), regardless of their geographic location, about which the United States may inquire in connection with any Civil Federal Proceeding, including but not limited to all information about activities of GS Caltex and present and former officers, directors, employees, and agents of GS Caltex;
(b) Making available in the United States, at no expense to the United States, its present officers, directors, employees, and agents to provide information and/or testimony as requested by the United States in connection with any Civil Federal Proceeding, including the provision of testimony in trial and other judicial proceedings, as well as interviews with law enforcement authorities, consistent with the rights and privileges of those individuals;
(c) Using its best efforts to make available in the United States, at no expense to the United States, its former officers, directors, employees, and agents to provide information and/or testimony as requested by the United States in connection with any Civil
(d) Providing testimony or information necessary to identify or establish the original location, authenticity, or other basis for admission into evidence of documents or physical evidence produced by GS Caltex in any Civil Federal Proceeding as requested by the United States; and
(e) Completely and truthfully responding to all other inquiries of the United States in connection with any Civil Federal Proceeding.
However, notwithstanding any provision of this Final Judgment, GS Caltex is not required to: (1) Request of its current or former officers, directors, employees, or agents that they forgo seeking the advice of an attorney nor that they act contrary to that advice; (2) take any action against its officers, directors, employees, or agents for following their attorney's advice; or (3) waive any claim of privilege or work product protection.
The obligations of GS Caltex to cooperate fully with the United States as described in this Section shall cease upon the conclusion of all Civil Federal Proceedings (which may include Civil Federal Proceedings related to the conduct of third parties), including exhaustion of all appeals or expiration of time for all appeals of any Court ruling in each such Civil Federal Proceeding, at which point the United States will provide written notice to GS Caltex that its obligations under this Section have expired.
A. Within thirty (30) days after entry of this Final Judgment, GS Caltex shall appoint an Antitrust Compliance Officer and identify to the United States his or her name, business address, telephone number, and email address. Within forty-five (45) days of a vacancy in the Antitrust Compliance Officer position, GS Caltex shall appoint a replacement, and shall identify to the United States the Antitrust Compliance Officer's name, business address, telephone number, and email address. GS Caltex's initial or replacement appointment of an Antitrust Compliance Officer is subject to the approval of the United States, in its sole discretion.
B. The Antitrust Compliance Officer shall institute an antitrust compliance program for the company's employees and directors with responsibility for bidding for any contract with the United States. The antitrust compliance program shall provide at least two hours of training annually on the antitrust laws of the United States, such training to be delivered by an attorney with
C. Each Antitrust Compliance Officer shall obtain, within six months after entry of this Final Judgment, and on an annual basis thereafter, on or before each anniversary of the entry of this Final Judgment, from each person subject to Paragraph V.B of this Final Judgment, and thereafter maintaining, a certification that each such person has received the required two hours of annual antitrust training.
D. Each Antitrust Compliance Officer shall communicate annually to all employees that they may disclose to the Antitrust Compliance Officer, without reprisal, information concerning any potential violation of the United States antitrust laws.
E. Each Antitrust Compliance Offer shall provide to the United States within six months after entry of this Final Judgment, and on an annual basis thereafter, on or before each anniversary of the entry of this Final Judgment, a written statement as to the fact and manner of GS Caltex's compliance with Section V of this Final Judgment.
This Court retains jurisdiction to enable any of the parties to this Final Judgment to apply to this Court at any time for further orders and directions as may be necessary or appropriate to carry out or construe this Final Judgment, to modify or terminate any of its provisions, to enforce compliance, and to punish violations of its provisions.
A. The United States retains and reserves all rights to enforce the provisions of this Final Judgment, including the right to seek an order of contempt from the Court. GS Caltex agrees that in any civil contempt action, any motion to show cause, or any similar action brought by the United States regarding an alleged violation of this Final Judgment, the United States may establish a violation of the decree and the appropriateness of any remedy therefor by a preponderance of the evidence, and GS Caltex waives any argument that a different standard of proof should apply.
B. The Final Judgment should be interpreted to give full effect to the procompetitive purposes of the antitrust laws and to restore all competition the United States alleged was harmed by the challenged conduct. GS Caltex agrees that they may be held in contempt of, and that the Court may enforce, any provision of this Final Judgment that, as interpreted by the Court in light of these procompetitive principles and applying ordinary tools of interpretation, is stated specifically and in reasonable detail, whether or not it is clear and unambiguous on its face. In any such interpretation, the terms of this Final Judgment should not be construed against either party as the drafter.
C. In any enforcement proceeding in which the Court finds that GS Caltex has violated this Final Judgment, the United States may apply to the Court for a one-time extension of this Final Judgment, together with such other relief as may be appropriate. In connection with any successful effort by the United States to enforce this Final Judgment against GS Caltex, whether litigated or resolved prior to litigation, GS Caltex agrees to reimburse the United States for the fees and expenses of its attorneys, as well as any other costs including experts' fees, incurred in connection with that enforcement effort, including in the investigation of the potential violation.
Unless this Court grants an extension, this Final Judgment shall expire seven (7) years from the date of its entry, except that after five (5) years from the date of its entry, this Final Judgment may be terminated upon notice by the United States to the Court and GS Caltex that the continuation of the Final Judgment no longer is necessary or in the public interest.
Entry of this Final Judgment is in the public interest. The parties have complied with the requirements of the Antitrust Procedures and Penalties Act, 15 U.S.C. § 16, including making copies available to the public of this Final Judgment, the Competitive Impact Statement, and any comments thereon and the United States' responses to comments. Based upon the record before the Court, which includes the Competitive Impact Statement and any comments and response to comments filed with the Court, entry of this Final Judgment is in the public interest.
This Settlement Agreement (Agreement) is entered into among the United States of America, acting through the Civil Division of the United States Department of Justice and the United States Attorney's Office for the Southern District of Ohio, on behalf of the Defense Logistics Agency (DLA) and the Army and Air Force Exchange Service (AAFES) (collectively the “United States”), GS Caltex Corporation (GS Caltex), and Relator [REDACTED] (hereafter collectively referred to as “the Parties”), through their authorized representatives.
A. GS Caltex is a South Korea-based energy company that produces various petroleum products that it sells to South Korean and international customers, including the United States Department of Defense (DoD).
B. On February 28, 2018, Relator, a resident and citizen of South Korea, filed a
C. On such date as may be determined by the Court, GS Caltex will plead guilty pursuant to Fed. R. Crim. P. 11(c)(1)(C) (the “Plea Agreement”) to an Information to be filed in
D. GS Caltex will execute a Stipulation with the Antitrust Division of the United States Department of Justice in which GS Caltex will consent to the entry of a Final Judgment to be filed in
E. The United States contends that it has certain civil claims against GS Caltex arising from a conspiracy with other South Korean entities to rig bids on DoD contracts to supply fuel to U.S. military bases throughout South Korea executed between 2005 and 2013, including DLA PC&S contracts and AAFES contracts, as well as the conduct described in the Plea Agreement in the Criminal Action. The conduct referenced in this Paragraph, as well as the conduct, actions, and claims alleged by Relator in the Civil FCA Action is referred to below as the Covered Conduct.
F. With the exception of any admissions that are made by GS Caltex in connection with the Plea Agreement in the Criminal Action, this Settlement Agreement is neither an admission of liability by GS Caltex nor a concession by the United States or Relator that their claims are not well founded.
G. Relator claims entitlement under 31 U.S.C. § 3730(d) to a share of the proceeds of this Settlement Agreement and to Relator's reasonable expenses, attorneys' fees and costs.
To avoid the delay, uncertainty, inconvenience, and expense of protracted litigation of the above claims, and in consideration of the mutual promises and obligations of this Settlement Agreement, the Parties agree and covenant as follows:
1.a. GS Caltex shall pay to the United States $42,621,000 (FCA Settlement Amount), of which $28,414,474 is restitution. Relator's right pursuant to 31 U.S.C. § 3730(d) to reasonable expenses, attorneys' fees and costs will be addressed separately by Relator, Relator's counsel and GS Caltex.
1.b. Interest at an annual rate of three (3) percent shall accrue on the FCA Settlement Amount beginning on the Effective Date of this Agreement and continuing until the date that both of the following events have occurred: (i) the Plea Agreement is accepted by the Court in the Criminal Action; and (ii) the proposed Final Judgment is entered by the Court in the Civil Antitrust Action (Accrued Interest).
1.c. The total FCA payment due from GS Caltex shall be the FCA Settlement Amount plus any Accrued Interest (Total FCA Settlement Amount). GS Caltex shall pay the Total FCA Settlement Amount by electronic funds transfer no later than seven (7) business days after both events identified above in Paragraph 1.b. have occurred (Payment Due Date). The Civil Division of the United States Department of Justice shall provide to counsel for GS Caltex written payment instructions and confirmation of the Total FCA Settlement Amount no later than five (5) business days before the Payment Due Date. If GS Caltex does not pay the Total FCA Settlement Amount on or before the Payment Due Date, interest at an annual rate of nine (9) percent shall accrue on the Total FCA Settlement Amount beginning on the first calendar day after the Payment Due Date and shall continue to accrue until paid.
1.d. If GS Caltex's Plea Agreement in the Criminal Action is not accepted by the Court or the Court does not enter the Final Judgment in the Civil Antitrust Action, this Agreement shall be null and void at the option of either the United States or GS Caltex. If either the United States or GS Caltex exercises this option, which option shall be exercised by notifying all Parties, through counsel, in writing within five (5) business days of the Court's decision, the Parties will not object and this Agreement will be rescinded. If this Agreement is rescinded, GS Caltex will not plead, argue or otherwise raise any defenses under the theories of statute of limitations, laches, estoppel or similar theories, to any civil or administrative claims, actions or proceedings arising from the Covered Conduct that are brought by the United States within ninety (90) calendar days of rescission, except to the extent such defenses were available on the day on which Relator's
2. Subject to the exceptions in Paragraph 3 (concerning excluded claims) below, and conditioned upon GS Caltex's full payment of the Total FCA Settlement Amount, the United States releases GS Caltex together with its current and former parent corporations; direct and indirect subsidiaries; brother or sister corporations; divisions; current or former corporate owners; and the corporate successors and assigns of any of them from any civil or administrative monetary claim the United States has for the Covered Conduct under the False Claims Act, 31 U.S.C. §§ 3729-3733; the Program Fraud Civil Remedies Act, 31 U.S.C. §§ 3801-3812; Contract Disputes Act, 41 U.S.C. §§ 7101-7109; or the common law theories of breach of contract, payment by mistake, unjust enrichment, and fraud, or under any statute creating causes of action for civil damages or civil penalties which the Civil Division of the United States Department of Justice has authority to assert and compromise pursuant to 28 C.F.R. Part O, Subpart I, § 0.45(d).
3. Notwithstanding the release given in paragraph 2 of this Agreement, or any other term of this Agreement, the following claims of the United States are specifically reserved and are not released:
a. Any liability arising under Title 26, U.S. Code (Internal Revenue Code);
b. Any criminal liability, except to the extent detailed in the Plea Agreement;
c. Except as explicitly stated in this Agreement, any administrative liability, including the suspension and debarment rights of any federal agency;
d. Any liability to the United States (or its agencies) for any conduct other than the Covered Conduct;
e. Any liability based upon obligations created by this Agreement;
f. Any liability of individuals;
g. Any liability for express or implied warranty claims or other claims for defective or deficient products or services, including quality of goods and services;
h. Any liability for failure to deliver goods or services due; and
i. Any liability for personal injury or property damage or for other consequential damages arising from the Covered Conduct.
4. Relator and his heirs, successors, attorneys, agents, and assigns shall not object to this Agreement but agree and confirm that this Agreement is fair, adequate, and reasonable under all the circumstances, pursuant to 31 U.S.C. § 3730(c)(2)(B). The determination of Relator's share, if any, of the FCA Settlement Amount pursuant to 31 U.S.C. § 3730(d) is a matter that shall be handled separately by and between the Relator and the United States, without any direct involvement or input from GS Caltex. In connection with this Agreement and this Civil FCA Action, Relator, on behalf of himself and his heirs, successors, attorneys, agents, and assigns agrees that neither this Agreement, nor any intervention by the United States in the Civil FCA Action in order to dismiss the Civil FCA Action, nor any dismissal of the Civil FCA Action, shall waive or otherwise affect the ability of the United States to contend that provisions in the False Claims Act, including 31 U.S.C. § 3730(d)(3), bar Relator from sharing in the proceeds of this Agreement, except that the United States will not contend that Relator is barred from sharing in the proceeds of this Agreement pursuant to
5. Relator, for himself, and for his heirs, successors, attorneys, agents, and assigns, releases GS Caltex, together with its predecessors, successors, assigns, shareholders, subsidiaries, businesses, affiliates, divisions, sister companies, owners, directors, officers, agents, employees, and counsel, from any action, in law or in equity, suits, debts, liens, contracts, agreements, covenants, promises, liability, obligations, claims, demands, rights of subrogation, contribution and indemnity, damages, loss, cost or expenses, direct or indirect, of any kind or nature whatsoever (including without limitation any civil monetary claim Relator has on behalf of the United States for the Covered Conduct under the False Claims Act. 31 U.S.C. §§ 3729-3733), known or unknown, fixed or contingent, foreign (including Korean), state or federal, under common law, statute or regulation, liquidated or unliquidated, claimed or concealed, and without regard to the date of occurrence, which Relator ever had, now has, may assert, or may in the future claim to have, against GS Caltex by reason of any act, cause, matter, or thing whatsoever from the beginning of time to the date hereof. Relator represents and warrants that he and his counsel are the exclusive owner of the rights, claims, and causes of action herein released and none of them have previously assigned, reassigned, or transferred or purported to assign, reassign or transfer, through bankruptcy or by any other means, any or any portion of any claim, demand, action, cause of action, or other right released or discharged under this Agreement except between themselves and their counsel. Notwithstanding the foregoing, or any other terms of this Agreement, this Agreement does not resolve or release Relator's right pursuant to 31 U.S.C. § 3730(d) to reasonable expenses necessarily incurred, plus reasonable attorneys' fees and costs relating to the Covered Conduct, the amount of which will be addressed separately by Relator, Relator's counsel, and GS Caltex.
6. GS Caltex waives and shall not assert any defenses GS Caltex may have to any criminal prosecution or administrative action relating to the Covered Conduct that may be based in whole or in part on a contention that, under the Double Jeopardy Clause in the Fifth Amendment of the Constitution, or under the Excessive Fines Clause in the Eighth Amendment of the Constitution, this Agreement bars a remedy sought in such criminal prosecution or administrative action.
7. GS Caltex fully and finally releases the United States, its agencies, officers, agents, employees, and servants, from any claims (including attorney's fees, costs, and expenses of every kind and however denominated) that GS Caltex has asserted, could have asserted, or may assert in the future against the United States, its agencies, officers, agents, employees, and servants, related to the Covered Conduct and the United States' investigation and prosecution thereof.
8. GS Caltex, for itself and on behalf of its predecessors, successors, assigns, shareholders, subsidiaries, businesses, affiliates, divisions, sister companies, owners, directors, officers, agents, employees, and counsel, releases Relator, together with his heirs, successors, attorneys, agents, and assigns from any action, in law or in equity, suits, debts, liens, contracts, agreements, covenants, promises, liability, obligations, claims, demands, rights of subrogation, contribution and indemnity, damages, loss, cost or expenses, direct or indirect, of any kind or nature whatsoever, known or unknown, fixed or contingent, foreign (including Korean), state or federal, under common law, statute or regulation, liquidated or unliquidated, claimed or concealed, and without regard to the date of occurrence, which GS Caltex ever had, now has, may assert, or may in the future claim to have, against Relator by reason of any act, cause, matter, or thing whatsoever from the beginning of time to the date hereof. GS Caltex represents and warrants that it and its counsel are the exclusive owner of the rights, claims, and causes of action herein released and none of them have previously assigned, reassigned, or transferred or purported to assign, reassign or transfer, through bankruptcy or by any other means, any or any portion of any claim, demand, action, cause of action, or other right released or discharged under this Agreement except between themselves and their counsel. Notwithstanding the foregoing, or any other terms of this Agreement, this Agreement does not resolve or release GS Caltex's right pursuant to 31 U.S.C. § 3730(d) to assert defenses to Relator's claimed attorneys' fees, expenses, and costs relating to the Covered Conduct, the amount of which will be addressed separately by Relator, Relator's counsel, and GS Caltex.
9. a. Unallowable Costs Defined: All costs (as defined in the Federal Acquisition Regulation, 48 C.F.R. § 31.205-47) incurred by or on behalf of GS Caltex, and its present or former officers, directors, employees, shareholders, and agents in connection with:
(1) the matters covered by this Agreement, any related plea agreement, and any related civil antitrust agreement;
(2) the United States' audit(s) and civil and any criminal investigation(s) of the matters covered by this Agreement;
(3) GS Caltex's investigation, defense, and corrective actions undertaken in response to the United States' audit(s) and civil and any criminal investigation(s) in connection with the matters covered by this Agreement (including attorney's fees);
(4) the negotiation and performance of this Agreement, any related plea agreement, and any related civil antitrust agreement;
(5) the payment GS Caltex makes to the United States pursuant to this Agreement and any payments that GS Caltex may make to Relator, including costs and attorneys' fees, are unallowable costs for government contracting purposes (hereinafter referred to as Unallowable Costs).
b. Future Treatment of Unallowable Costs: Unallowable Costs will be separately determined and accounted for by GS Caltex, and GS Caltex shall not charge such Unallowable Costs directly or indirectly to any contract with the United States.
c. Treatment of Unallowable Costs Previously Submitted for Payment: Within 90 days of the Effective Date of this Agreement, GS Caltex shall identify and repay by adjustment to future claims for payment or otherwise any Unallowable Costs included in payments previously sought by GS Caltex or any of its subsidiaries or affiliates from the United States. GS Caltex agrees that the United States, at a minimum, shall be entitled to recoup from GS Caltex any overpayment plus applicable interest and penalties as a result of the inclusion of such Unallowable Costs on previously-submitted requests for payment. The United States, including the Department of Justice and/or the affected agencies, reserves its rights to audit, examine, or re-examine GS Caltex's books and records and to disagree with any calculations submitted by GS Caltex or any of its subsidiaries or affiliates regarding any Unallowable Costs included in payments previously sought
10. GS Caltex agrees to cooperate fully and truthfully with the United States in connection with the Civil FCA Action. The Civil Division of the United States Department of Justice will use reasonable best efforts, where appropriate, to coordinate any requests for cooperation in connection with the Civil FCA Action with requests for cooperation in connection with the Plea Agreement in the Criminal Action and the Civil Antitrust Action, so as to avoid unnecessary duplication and expense. GS Caltex's ongoing, full, and truthful cooperation shall include, but not be limited to:
a. upon request by the United States with reasonable notice, producing at the offices of counsel for the United States in Washington, D.C. and not at the expense of the United States, complete and un-redacted copies of all non-privileged documents related to the Covered Conduct wherever located in GS Caltex's possession, custody, or control;
b. upon request by the United States with reasonable notice, making current GS Caltex directors, officers, and employees available for interviews, consistent with the rights and privileges of such individuals, by counsel for the United States and/or their investigative agents, not at the expense of the United States, in the United States or Hong Kong unless another place is mutually agreed upon;
c. upon request by the United States with reasonable notice, (i) using best efforts to assist in locating former GS Caltex directors, officers, and employees identified by attorneys and/or investigative agents of the United States, and (ii) using best efforts to make any such former GS Caltex directors, officers, and employees available for interviews, consistent with the rights and privileges of such individuals, by counsel for the United States and/or their investigative agents, not at the expense of the United States, in the United States or Hong Kong unless another place is mutually agreed upon; and
d. upon request by the United States with reasonable notice, making current GS Caltex directors, officers, and employees available, and using best efforts to make former GS Caltex directors, officers, employees available, to testify, consistent with the rights and privileges of such individuals, fully, truthfully, and under oath, without falsely implicating any person or withholding any information, (i) at depositions in the United States, Hong Kong, or any other mutually agreed upon place, (ii) at trial in the United States, and (iii) at any other judicial proceedings wherever located related to the Civil FCA Action.
11. This Agreement is intended to be for the benefit of the Parties only.
12. Upon receipt of the payment of the Total FCA Settlement Amount described in Paragraph 1.a-c., above, or receipt of the Total FCA Settlement Amount and any additional interest that accrues if GS Caltex does not pay on or before the Payment Due Date, the United States and Relator shall promptly sign and file a Joint Stipulation of Dismissal, with prejudice, of the claims filed against GS Caltex in the Civil FCA Action, pursuant to Rule 41(a)(1), which dismissal shall be conditioned on the Court retaining jurisdiction over Relator's claims to a relator's share and recovery of attorneys' fees and costs pursuant to 31 U.S.C. § 3730(d).
13. Except as provided herein, each Party shall bear its own legal and other costs incurred in connection with this matter. The Parties agree that Relator and GS Caltex will not seek to recover from the United States any costs or fees related to the preparation and performance of this Agreement.
14. Each party and signatory to this Agreement represents that it freely and voluntarily enters into this Agreement without any degree of duress or compulsion.
15. This Agreement is governed by the laws of the United States. The exclusive jurisdiction and venue for any dispute relating to this Agreement is the United States District Court for the Southern District of Ohio. GS Caltex agrees that the United States District Court for the Southern District of Ohio has jurisdiction over it for purposes of the Civil FCA Action. For purposes of construing this Agreement, this Agreement shall be deemed to have been drafted by all Parties to this Agreement and shall not, therefore, be construed against any Party for that reason in any subsequent dispute.
16. This Agreement constitutes the complete agreement between the Parties on the subject matters addressed herein. This Agreement may not be amended except by written consent of the Parties.
17. The undersigned counsel represent and warrant that they are fully authorized to execute this Agreement on behalf of the persons and entities indicated below.
18. This Agreement may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same Agreement.
19. This Agreement is binding on GS Caltex's successors, transferees, heirs, and assigns.
20. This Agreement is binding on Relator's successors, transferees, heirs, and assigns.
21. All parties consent to the United States' disclosure of this Agreement, and information about this Agreement, to the public, as permitted by order of the Court. This Agreement shall not be released in un-redacted form until the Court unseals the entire Civil FCA Action.
22. This Agreement is effective on the date of signature of the last signatory to the Agreement (Effective Date of this Agreement). Electronic copies of signatures shall constitute acceptable, binding signatures for purposes of this Agreement
WHEREAS Plaintiff, United States of America, filed its Complaint on November 14, 2018, the United States and Defendant Hanjin Transportation Co., Ltd. (“Hanjin”), by their respective attorneys, have consented to the entry of this Final Judgment without trial or adjudication of any issue of fact or law;
WHEREAS, on such date as may be determined by the Court, Hanjin will plead guilty pursuant to Fed. R. Crim. P. 11(c)(1)(C) (the “Plea Agreement”) to an Information to be filed in United States v. Hanjin Transportation Co., Ltd. [to be assigned] (S.D.Ohio) (the “Criminal Action”) that will allege a violation of Section 1 of the Sherman Act, 15 U.S. C. § 1, relating to the same events giving rise to the allegations described in the Complaint;
WHEREAS, this Final Judgment does not constitute any evidence against or admission by any party regarding any issue of fact or law;
NOW, THEREFORE, before the taking of any testimony and without trial or final adjudication of any issue of fact or law herein, and upon consent of the parties hereto, it is hereby ORDERED, ADJUDGED, AND DECREED:
This Court has jurisdiction of the subject matter of this action and each of the parties consenting hereto. The Complaint states a claim upon which relief may be granted to the United States against Hanjin under Section 1 of the Sherman Act, 15 U.S.C. § 1.
This Final Judgment applies to Hanjin, as defined above, and all other persons in active concert or participation with any of them who receive actual notice of this Final Judgment by personal service or otherwise.
Hanjin shall pay to the United States within ten (10) business days of the entry of this Final Judgment the amount of six million, one hundred eighty-two thousand ($6,182,000), less the amount paid (excluding any interest) pursuant to the settlement agreement attached hereto as Attachment 1, to satisfy all civil antitrust claims alleged against Hanjin by the United States in the Complaint. Payment of the amount ordered hereby shall be made by wire transfer of funds or cashier's check. If the payment is made by wire transfer, Hanjin shall contact Janie Ingalls of the Antitrust Division's Antitrust Documents Group at (202) 514-2481 for instructions before making the transfer. If the payment is made by cashier's check, the check shall be made payable to the United States Department of Justice and delivered to: Janie Ingalls, United States Department of Justice Antitrust Division, Antitrust Documents Group, 450 5th Street, NW, Suite 1024, Washington, D.C. 20530. In the event of a default in payment, interest at the rate of eighteen (18) percent per annum shall accrue thereon from the date of default to the date of payment.
Hanjin shall cooperate fully with the United States regarding any matter about which Hanjin has knowledge or information relating to any ongoing civil investigation, litigation, or other proceeding arising out of any ongoing federal investigation of the subject matter discussed in the Complaint (hereinafter, any such investigation, litigation, or proceeding shall be referred to as a “Civil Federal Proceeding”).
The United States agrees that any cooperation provided in connection with the Plea Agreement and/or pursuant to the settlement agreement attached hereto as Attachment 1 will be considered cooperation for purposes of this Final Judgment, and the United States will use its reasonable best efforts, where appropriate, to coordinate any requests for cooperation in connection with the Civil Federal Proceeding with requests for cooperation in connection with the Plea Agreement and the settlement agreement attached hereto as Attachment 1, so as to avoid unnecessary duplication and expense. Hanjin's cooperation shall include, but not be limited to, the following:
(a) Upon request, completely and truthfully disclosing and producing, to the offices of the United States and at no expense to the United States, copies of all non-privileged information, documents, materials, and records in its possession (and for any foreign-language information, documents, materials, or records, copies must be produced with an English translation), regardless of their geographic location, about which the United States may inquire in connection with any Civil Federal Proceeding, including but not limited to all information about activities of Hanjin and present and former officers, directors, employees, and agents of Hanjin;
(b) Making available in the United States, at no expense to the United States, its present officers, directors, employees, and agents to provide information and/or testimony as requested by the United States in connection with any Civil Federal Proceeding, including the provision of testimony in trial and other judicial proceedings, as well as interviews with law enforcement authorities, consistent with the rights and privileges of those individuals;
(c) Using its best efforts to make available in the United States, at no expense to the United States, its former officers, directors, employees, and agents to provide information and/or testimony as requested by the United States in connection with any Civil Federal Proceeding, including the provision of testimony in trial and other judicial proceedings, as well as interviews with law enforcement authorities, consistent with the rights and privileges of those individuals;
(d) Providing testimony or information necessary to identify or establish the original location, authenticity, or other basis for admission into evidence of documents or physical evidence produced by Hanjin in any Civil Federal Proceeding as requested by the United States; and
(e) Completely and truthfully responding to all other inquiries of the United States in connection with any Civil Federal Proceeding.
However, notwithstanding any provision of this Final Judgment, Hanjin is not required to: (1) request of its current or former officers, directors, employees, or agents that they forgo seeking the advice of an attorney nor that they act contrary to that advice; (2) take any action against its officers, directors, employees, or agents for following their attorney's advice; or (3) waive any claim of privilege or work product protection.
The obligations of Hanjin to cooperate fully with the United States as described in this Section shall cease upon the conclusion of all Civil Federal Proceedings (which may include Civil Federal Proceedings related to the conduct of third parties), including exhaustion of all appeals or expiration of time for all appeals of any Court ruling in each such Civil Federal Proceeding, at which point the United States will provide written notice to Hanjin that its obligations under this Section have expired.
A. Within thirty (30) days after entry of this Final Judgment, Hanjin shall appoint an Antitrust Compliance Officer and identify to the United States his or her name, business address, telephone number, and email address. Within
B. The Antitrust Compliance Officer shall institute an antitrust compliance program for the company's employees and directors with responsibility for bidding for any contract with the United States. The antitrust compliance program shall provide at least two hours of training annually on the antitrust laws of the United States, such training to be delivered by an attorney with relevant experience in the field of United States antitrust law.
C. Each Antitrust Compliance Officer shall obtain, within six months after entry of this Final Judgment, and on an annual basis thereafter, on or before each anniversary of the entry of this Final Judgment, from each person subject to Paragraph V.B of this Final Judgment, and thereafter maintaining, a certification that each such person has received the required two hours of annual antitrust training.
D. Each Antitrust Compliance Officer shall communicate annually to all employees that they may disclose to the Antitrust Compliance Officer, without reprisal, information concerning any potential violation of the United States antitrust laws.
E. Each Antitrust Compliance Offer shall provide to the United States within six months after entry of this Final Judgment, and on an annual basis thereafter, on or before each anniversary of the entry of this Final Judgment, a written statement as to the fact and manner of Hanjin's compliance with Section V of this Final Judgment.
This Court retains jurisdiction to enable any of the parties to this Final Judgment to apply to this Court at any time for further orders and directions as may be necessary or appropriate to carry out or construe this Final Judgment, to modify or terminate any of its provisions, to enforce compliance, and to punish violations of its provisions.
A. The United States retains and reserves all rights to enforce the provisions of this Final Judgment, including the right to seek an order of contempt from the Court. Hanjin agrees that in any civil contempt action, any motion to show cause, or any similar action brought by the United States regarding an alleged violation of this Final Judgment, the United States may establish a violation of the decree and the appropriateness of any remedy therefor by a preponderance of the evidence, and Hanjin waives any argument that a different standard of proof should apply.
B. The Final Judgment should be interpreted to give full effect to the procompetitive purposes of the antitrust laws and to restore all competition the United States alleged was harmed by the challenged conduct. Hanjin agrees that they may be held in contempt of, and that the Court may enforce, any provision of this Final Judgment that, as interpreted by the Court in light of these procompetitive principles and applying ordinary tools of interpretation, is stated specifically and in reasonable detail, whether or not it is clear and unambiguous on its face. In any such interpretation, the terms of this Final Judgment should not be construed against either party as the drafter.
C. In any enforcement proceeding in which the Court finds that Hanjin has violated this Final Judgment, the United States may apply to the Court for a one-time extension of this Final Judgment, together with such other relief as may be appropriate. In connection with any successful effort by the United States to enforce this Final Judgment against Hanjin, whether litigated or resolved prior to litigation, Hanjin agrees to reimburse the United States for the fees and expenses of its attorneys, as well as any other costs including experts' fees, incurred in connection with that enforcement effort, including in the investigation of the potential violation.
Unless this Court grants an extension, this Final Judgment shall expire seven (7) years from the date of its entry, except that after five (5) years from the date of its entry, this Final Judgment may be terminated upon notice by the United States to the Court and Hanjin that the continuation of the Final Judgment no longer is necessary or in the public interest.
Entry of this Final Judgment is in the public interest. The parties have complied with the requirements of the Antitrust Procedures and Penalties Act, 15 U.S.C. § 16, including making copies available to the public of this Final Judgment, the Competitive Impact Statement, and any comments thereon and the United States' responses to comments. Based upon the record before the Court, which includes the Competitive Impact Statement and any comments and response to comments filed with the Court, entry of this Final Judgment is in the public interest.
This Settlement Agreement (Agreement) is entered into among the United States of America, acting through the Civil Division of the United States Department of Justice and the United States Attorney's Office for the Southern District of Ohio, on behalf of the Defense Logistics Agency (DLA) and the Army and Air Force Exchange Service (AAFES) (collectively the “United States”), Hanjin Transportation Co., Ltd. (Hanjin), and Relator [REDACTED] (hereafter collectively referred to as “the Parties”), through their authorized representatives.
A. Hanjin is a South Korea-based logistics company with South Korean and international customers, including the United States Department of Defense (DoD).
B. On February 28, 2018, Relator, a resident and citizen of South Korea, filed a
C. On such date as may be determined by the Court, Hanjin will plead guilty pursuant to Fed. R. Crim. P. 11(c)(1)(C) (the “Plea Agreement”) to an Information to be filed in
D. Hanjin will execute a Stipulation with the Antitrust Division of the United States Department of Justice in which Hanjin will consent to the entry of a Final Judgment to be filed in
E. The United States contends that it has certain civil claims against Hanjin arising from a conspiracy with other South Korean entities to rig bids on DoD contracts to supply fuel to U.S. military bases throughout South Korea beginning in 2008 and continuing to 2016, including DLA Post, Camps, and Stations contracts executed in 2009 and 2013, and AAFES contracts executed in 2008. The conduct described in in this Paragraph, as well as the conduct, actions, and claims alleged by Relator in the Civil FCA Action is referred to below as the Covered Conduct.
F. With the exception of any admissions that are made by Hanjin in connection with the Plea Agreement in the Criminal Action, this Settlement Agreement is neither an admission of liability by Hanjin nor a concession by the United States or Relator that their claims are not well founded.
G. Relator claims entitlement under 31 U.S.C. § 3730(d) to a share of the proceeds of this Settlement Agreement and to Relator's reasonable expenses, attorneys' fees, and costs.
To avoid the delay, uncertainty, inconvenience, and expense of protracted litigation of the above claims, and in consideration of the mutual promises and obligations of this Settlement Agreement, the Parties agree and covenant as follows:
1. Hanjin agrees to pay to the United States $6,182,000 (FCA Settlement Amount) by electronic funds transfer no later than thirteen (13) business days after the Effective Date of this Agreement pursuant to written instructions to be provided by the Civil Division of the United States Department of Justice. Relator claims entitlement under 31 U.S.C. § 3730(d) to Relator's reasonable expenses, attorneys' fees and costs. The FCA Settlement Amount does not include the Relator's fees and costs, and Hanjin acknowledges (without waiving any applicable arguments or defenses) that Relator retains all rights to seek to recover such expenses, attorneys' fees, and costs from Hanjin pursuant to 31 U.S.C. § 3730(d).
2. Subject to the exceptions in Paragraph 4 (concerning excluded claims) below, and conditioned upon Hanjin's full payment of the FCA Settlement Amount, the United States releases Hanjin together with its current and former parent corporations; direct and indirect subsidiaries; brother or sister corporations; divisions; current or former corporate owners; and the corporate successors and assigns of any of them from any civil or administrative monetary claim the United States has for the Covered Conduct under the False Claims Act, 31 U.S.C. §§ 3729-3733; the Program Fraud Civil Remedies Act, 31 U.S.C. §§ 3801-3812; Contract Disputes Act, 41 U.S.C. §§ 7101-7109; or the common law theories of breach of contract, payment by mistake, unjust enrichment, and fraud.
3. Except as set forth in Paragraph 1 (concerning Relator's claims under 31 U.S.C. § 3730(d)), and subject to the exceptions in Paragraph 4 below, and conditioned upon Hanjin's full payment of the FCA Settlement Amount, Relator, on behalf of: (a) his respective heirs, successors, assigns, agents and attorneys; and (b) his companies ([REDACTED], together with their direct and indirect subsidiaries, brother or sister corporations, divisions, current or former corporate owners, and the corporate successors and assigns of any of them); hereby fully and finally releases, waives, and forever discharges Hanjin, together with its direct and indirect subsidiaries, brother or sister corporations, divisions, current or former corporate owners, and the corporate successors and assigns of any of them, from: (i) any civil monetary claim Relator has on behalf of the United States for the Covered Conduct under the False Claims Act, 31 U.S.C. §§ 3729-3733; (ii) any claims or allegations Relator has asserted or could have asserted against Hanjin arising from the Covered Conduct; and (iii) all liability, claims, demands, actions or causes of action whatsoever, whether known or unknown, fixed or contingent, in law or in equity, in contract or in tort, under any federal, Korean, or state statute or regulation or otherwise, or in common law, including claims for attorneys' fees, costs, and expenses of every kind and however denominated, that Relator would have standing to bring or which Relator may now have or claim to have against Hanjin and/or its direct and indirect subsidiaries, brother or sister corporations, divisions, current or former corporate owners, and the corporate successors and assigns of any of them.
4. Notwithstanding the releases given in paragraphs 2 and 3 of this Agreement, or any other term of this Agreement, the following claims of the United States are specifically reserved and are not released:
a. Any liability arising under Title 26, U.S. Code (Internal Revenue Code);
b. Any criminal liability, except to the extent detailed in the Plea Agreement;
c. Except as explicitly stated in this Agreement, any administrative liability, including the suspension and debarment rights of any federal agency;
d. Any liability to the United States (or its agencies) for any conduct other than the Covered Conduct;
e. Any liability based upon obligations created by this Agreement;
f. Any liability of individuals;
g. Any liability for express or implied warranty claims or other claims for defective or deficient products or services, including quality of goods and services;
h. Any liability for failure to deliver goods or services due; and
i. Any liability for personal injury or property damage or for other consequential damages arising from the Covered Conduct.
5. Relator and his heirs, successors, attorneys, agents, and assigns shall not object to this Agreement but agree and confirm that this Agreement is fair, adequate, and reasonable under all the circumstances, pursuant to 31 U.S.C. § 3730(c)(2)(B). In connection with this Agreement and this Civil FCA Action, Relator, on behalf of himself and his heirs, successors, attorneys, agents, and assigns, agrees that neither this Agreement, nor any intervention by the United States in the Civil FCA Action in order to dismiss the Civil FCA Action, nor any dismissal of the Civil FCA Action, shall waive or otherwise affect the ability of the United States to contend that provisions in the False Claims Act, including 31 U.S.C. § 3730(d)(3), bar Relator from sharing in the proceeds of this Agreement, except that the United States will not contend that Relator is barred from sharing in the proceeds of this Agreement pursuant to 31 U.S.C. § 3730(e)(4). Moreover, the United States and Relator, on behalf of
6. Hanjin waives and shall not assert any defenses Hanjin may have to any criminal prosecution or administrative action relating to the Covered Conduct that may be based in whole or in part on a contention that, under the Double Jeopardy Clause in the Fifth Amendment of the Constitution, or under the Excessive Fines Clause in the Eighth Amendment of the Constitution, this Agreement bars a remedy sought in such criminal prosecution or administrative action.
7. Hanjin fully and finally releases the United States, its agencies, officers, agents, employees, and servants, from any claims (including attorney's fees, costs, and expenses of every kind and however denominated) that Hanjin has asserted, could have asserted, or may assert in the future against the United States, its agencies, officers, agents, employees, and servants, related to the Covered Conduct and the United States' investigation and prosecution thereof.
8. Hanjin, together with its direct and indirect subsidiaries, brother or sister corporations, divisions, current or former corporate owners, and the corporate successors and assigns of any of them, hereby fully and finally releases, waives, and forever discharges the Relator, together with his respective heirs, successors, assigns, agents and attorneys, and his companies ([REDACTED]) from any claims or allegations Hanjin has asserted or could have asserted, arising from the Covered Conduct, and from all liability, claims, demands, actions or causes of action whatsoever, whether known or unknown, fixed or contingent, in law or in equity, in contract or in tort, under any federal, Korean, or state statute or regulation or otherwise, or in common law, including claims for attorneys' fees, costs, and expenses of every kind and however denominated, that it would have standing to bring or which Hanjin may now have or claim to have against Relator and his heirs, successors, assigns, agents, and attorneys. Relator hereby represents that neither he nor his companies, [REDACTED], performed business with Hanjin.
9. a. Unallowable Costs Defined: All costs (as defined in the Federal Acquisition Regulation, 48 C.F.R. § 31.205-47) incurred by or on behalf of Hanjin, and its present or former officers, directors, employees, shareholders, and agents in connection with:
(1) the matters covered by this Agreement, any related plea agreement, and any related civil antitrust agreement;
(2) the United States' audit(s) and civil and any criminal investigation(s) of the matters covered by this Agreement;
(3) Hanjin's investigation, defense, and corrective actions undertaken in response to the United States' audit(s) and civil and any criminal investigation(s) in connection with the matters covered by this Agreement (including attorney's fees);
(4) the negotiation and performance of this Agreement, any related plea agreement, and any related civil antitrust agreement;
(5) the payment Hanjin makes to the United States pursuant to this Agreement and any payments that Hanjin may make to Relator, including costs and attorneys' fees,
b. Future Treatment of Unallowable Costs: Unallowable Costs will be separately determined and accounted for by Hanjin, and Hanjin shall not charge such Unallowable Costs directly or indirectly to any contract with the United States.
c. Treatment of Unallowable Costs Previously Submitted for Payment: Within 90 days of the Effective Date of this Agreement, Hanjin shall identify and repay by adjustment to future claims for payment or otherwise any Unallowable Costs included in payments previously sought by Hanjin or any of its subsidiaries or affiliates from the United States. Hanjin agrees that the United States, at a minimum, shall be entitled to recoup from Hanjin any overpayment plus applicable interest and penalties as a result of the inclusion of such Unallowable Costs on previously-submitted requests for payment. The United States, including the Department of Justice and/or the affected agencies, reserves its rights to audit, examine, or re-examine Hanjin's books and records and to disagree with any calculations submitted by Hanjin or any of its subsidiaries or affiliates regarding any Unallowable Costs included in payments previously sought by Hanjin, or the effect of any such Unallowable Costs on the amount of such payments.
10. Hanjin agrees to cooperate fully and truthfully with the United States in connection with the Civil FCA Action. Hanjin's ongoing, full, and truthful cooperation shall include, but not be limited to:
a. upon request by the United States with reasonable notice, producing at the offices of counsel for the United States in Washington, D.C. and not at the expense of the United States, complete and un-redacted copies of all non-privileged documents related to the Covered Conduct wherever located in Hanjin's possession, custody, or control, including but not limited to, reports, memoranda of interviews, and records concerning any investigation of the Covered Conduct that Hanjin has undertaken, or that has been performed by another on Hanjin's behalf;
b. upon request by the United States with reasonable notice, making current Hanjin directors, officers, and employees available for interviews, consistent with the rights and privileges of such individuals, by counsel for the United States and/or their investigative agents, not at the expense of the United States, in the United States or Hong Kong, unless another place is mutually agreed upon;
c. upon request by the United States with reasonable notice, (i) using best efforts to assist in locating former Hanjin directors, officers, and employees identified by attorneys and/or investigative agents of the United States, and (ii) using best efforts to make any such former Hanjin directors, officers, and employees available for interviews, consistent with the rights and privileges of such individuals, by counsel for the United States and/or their investigative agents, not at the expense of the United States, in the United States or Hong Kong, unless another place is mutually agreed upon; and
d. upon request by the United States with reasonable notice, making current Hanjin directors, officers, and employees available, and using best efforts to make former Hanjin directors, officers, employees available, to testify, consistent with the rights and privileges of such individuals, fully, truthfully, and under oath, without falsely implicating any person or withholding any information, (i) at depositions in the United States, Hong Kong, or any other mutually agreed upon place, (ii) at trial in the United States, and (iii) at any other judicial proceedings wherever located related to the Civil FCA Action.
11. This Agreement is intended to be for the benefit of the Parties only.
12. Upon receipt of the payment of the FCA Settlement Amount described in Paragraph 1 above, the United States and Relator shall promptly sign and file a Joint Stipulation of Dismissal, with prejudice, of the claims filed against
13. Except with respect to payment (if any) by Hanjin of Relator's attorneys' fees, expenses, and costs pursuant to 31 U.S.C. § 3730(d), each Party shall bear its own legal and other costs incurred in connection with this matter. The Parties agree that Relator and Hanjin will not seek to recover from the United States any costs or fees related to the preparation and performance of this Agreement.
14. Each party and signatory to this Agreement represents that it freely and voluntarily enters in to this Agreement without any degree of duress or compulsion.
15. This Agreement is governed by the laws of the United States. The exclusive jurisdiction and venue for any dispute relating to this Agreement is the United States District Court for the Southern District of Ohio. Hanjin agrees that the United States District Court for the Southern District of Ohio has jurisdiction over it for purposes of the Civil FCA Action. For purposes of construing this Agreement, this Agreement shall be deemed to have been drafted by all Parties to this Agreement and shall not, therefore, be construed against any Party for that reason in any subsequent dispute.
16. This Agreement constitutes the complete agreement between the Parties on the subject matters addressed herein. This Agreement may not be amended except by written consent of the Parties.
17. The undersigned counsel represent and warrant that they are fully authorized to execute this Agreement on behalf of the persons and entities indicated below.
18. This Agreement may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same Agreement.
19. This Agreement is binding on Hanjin's successors, transferees, heirs, and assigns.
20. This Agreement is binding on Relator's successors, transferees, heirs, and assigns.
21. All parties consent to the United States' disclosure of this Agreement, and information about this Agreement, to the public, as permitted by order of the Court. This Agreement shall not be released in un-redacted form until the Court unseals the entire Civil FCA Action.
22. This Agreement is effective on the date of signature of the last signatory to the Agreement (Effective Date of this Agreement). Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this Agreement.
WHEREAS Plaintiff, United States of America, filed its Complaint on November 14, 2018, the United States and Defendant SK Energy Co., Ltd. (“SK Energy”), by their respective attorneys, have consented to the entry of this Final Judgment without trial or adjudication of any issue of fact or law;
WHEREAS, on such date as may be determined by the Court, SK Energy will plead guilty pursuant to Fed. R. Crim. P. 11(c)(1)(C) (the “Plea Agreement”) to an Information to be filed in
WHEREAS, this Final Judgment does not constitute any evidence against or admission by any party regarding any issue of fact or law;
NOW, THEREFORE, before the taking of any testimony and without trial or final adjudication of any issue of fact or law herein, and upon consent of the parties hereto, it is hereby ORDERED, ADJUDGED, AND DECREED:
This Court has jurisdiction of the subject matter of this action and each of the parties consenting hereto. The Complaint states a claim upon which relief may be granted to the United States against SK Energy under Section 1 of the Sherman Act, 15 U.S.C. § 1.
This Final Judgment applies to SK Energy, as defined above, and all other persons in active concert or participation with any of them who receive actual notice of this Final Judgment by personal service or otherwise.
SK Energy shall pay to the United States within ten (10) business days of the entry of this Final Judgment the amount of ninety million, three hundred eighty-four thousand, eight hundred and seventy-two dollars ($90,384,872), less the amount paid (excluding any interest) pursuant to the settlement agreement attached hereto as Attachment 1, to satisfy all civil antitrust claims alleged against SK Energy by the United States in the Complaint. Payment of the amount ordered hereby shall be made by wire transfer of funds or cashier's check. If the payment is made by wire transfer, SK Energy shall contact Janie Ingalls of the Antitrust Division's Antitrust Documents Group at (202) 514-2481 for instructions before making the transfer. If the payment is made by cashier's check, the check shall be made payable to the United States Department of Justice and delivered to: Janie Ingalls, United States Department of Justice Antitrust Division, Antitrust Documents Group, 450 5th Street, NW, Suite 1024, Washington, D.C. 20530. In the event of a default in payment, interest at the rate of eighteen (18) percent per annum shall accrue thereon from the date of default to the date of payment.
SK Energy shall cooperate fully with the United States regarding any matter about which SK Energy has knowledge or information relating to any ongoing civil investigation, litigation, or other proceeding arising out of any ongoing federal investigation of the subject matter discussed in the Complaint (hereinafter, any such investigation, litigation, or proceeding shall be referred to as a “Civil Federal Proceeding”).
The United States agrees that any cooperation provided in connection with the Plea Agreement and/or pursuant to the settlement agreement attached hereto as Attachment 1 will be considered cooperation for purposes of this Final Judgment, and the United States will use its reasonable best efforts, where appropriate, to coordinate any requests for cooperation in connection with the Civil Federal Proceeding with requests for cooperation in connection with the Plea Agreement and the settlement agreement attached hereto as Attachment 1, so as to avoid unnecessary duplication and expense.
SK Energy's cooperation shall include, but not be limited to, the following:
(a) Upon request, completely and truthfully disclosing and producing, to the offices of the United States and at no expense to the United States, copies of all non-privileged information, documents, materials, and records in its possession (and for any foreign-language information, documents, materials, or records, copies must be produced with an English translation), regardless of their geographic location, about which the United States may inquire in connection with any Civil Federal Proceeding, including but not limited to all information about activities of SK Energy and present and former officers, directors, employees, and agents of SK Energy;
(b) Making available in the United States, at no expense to the United States, its present officers, directors, employees, and agents to provide information and/or testimony as requested by the United States in connection with any Civil Federal Proceeding, including the provision of testimony in trial and other judicial proceedings, as well as interviews with law enforcement authorities, consistent with the rights and privileges of those individuals;
(c) Using its best efforts to make available in the United States, at no expense to the United States, its former officers, directors, employees, and agents to provide information and/or testimony as requested by the United States in connection with any Civil
(d) Providing testimony or information necessary to identify or establish the original location, authenticity, or other basis for admission into evidence of documents or physical evidence produced by SK Energy in any Civil Federal Proceeding as requested by the United States; and
(e) Completely and truthfully responding to all other inquiries of the United States in connection with any Civil Federal Proceeding.
However, notwithstanding any provision of this Final Judgment, SK Energy is not required to: (1) request of its current or former officers, directors, employees, or agents that they forgo seeking the advice of an attorney nor that they act contrary to that advice; (2) take any action against its officers, directors, employees, or agents for following their attorney's advice; or (3) waive any claim of privilege or work product protection.
The obligations of SK Energy to cooperate fully with the United States as described in this Section shall cease upon the conclusion of all Civil Federal Proceedings (which may include Civil Federal Proceedings related to the conduct of third parties), including exhaustion of all appeals or expiration of time for all appeals of any Court ruling in each such Civil Federal Proceeding, at which point the United States will provide written notice to SK Energy that its obligations under this Section have expired.
A. Within thirty (30) days after entry of this Final Judgment, SK Energy shall appoint an Antitrust Compliance Officer and identify to the United States his or her name, business address, telephone number, and email address. Within forty-five (45) days of a vacancy in the Antitrust Compliance Officer position, SK Energy shall appoint a replacement, and shall identify to the United States the Antitrust Compliance Officer's name, business address, telephone number, and email address. SK Energy's initial or replacement appointment of an Antitrust Compliance Officer is subject to the approval of the United States, in its sole discretion.
B. The Antitrust Compliance Officer shall institute an antitrust compliance program for the company's employees and directors with responsibility for bidding for any contract with the United States. The antitrust compliance program shall provide at least two hours of training annually on the antitrust laws of the United States, such training to be delivered by an attorney with relevant experience in the field of United States antitrust law.
C. Each Antitrust Compliance Officer shall obtain, within six months after entry of this Final Judgment, and on an annual basis thereafter, on or before each anniversary of the entry of this Final Judgment, from each person subject to Paragraph V.B of this Final Judgment, and thereafter maintaining, a certification that each such person has received the required two hours of annual antitrust training.
D. Each Antitrust Compliance Officer shall communicate annually to all employees that they may disclose to the Antitrust Compliance Officer, without reprisal, information concerning any potential violation of the United States antitrust laws.
E. Each Antitrust Compliance Offer shall provide to the United States within six months after entry of this Final Judgment, and on an annual basis thereafter, on or before each anniversary of the entry of this Final Judgment, a written statement as to the fact and manner of SK Energy's compliance with Section V of this Final Judgment.
This Court retains jurisdiction to enable any of the parties to this Final Judgment to apply to this Court at any time for further orders and directions as may be necessary or appropriate to carry out or construe this Final Judgment, to modify or terminate any of its provisions, to enforce compliance, and to punish violations of its provisions.
A. The United States retains and reserves all rights to enforce the provisions of this Final Judgment, including the right to seek an order of contempt from the Court. SK Energy agrees that in any civil contempt action, any motion to show cause, or any similar action brought by the United States regarding an alleged violation of this Final Judgment, the United States may establish a violation of the decree and the appropriateness of any remedy therefor by a preponderance of the evidence, and SK Energy waives any argument that a different standard of proof should apply.
B. The Final Judgment should be interpreted to give full effect to the
C. In any enforcement proceeding in which the Court finds that SK Energy has violated this Final Judgment, the United States may apply to the Court for a one-time extension of this Final Judgment, together with such other relief as may be appropriate. In connection with any successful effort by the United States to enforce this Final Judgment against SK Energy, whether litigated or resolved prior to litigation, SK Energy agrees to reimburse the United States for the fees and expenses of its attorneys, as well as any other costs including experts' fees, incurred in connection with that enforcement effort, including in the investigation of the potential violation.
Unless this Court grants an extension, this Final Judgment shall expire seven (7) years from the date of its entry, except that after five (5) years from the date of its entry, this Final Judgment may be terminated upon notice by the United States to the Court and SK Energy that the continuation of the Final Judgment no longer is necessary or in the public interest.
Entry of this Final Judgment is in the public interest. The parties have complied with the requirements of the Antitrust Procedures and Penalties Act, 15 U.S.C. § 16, including making copies available to the public of this Final Judgment, the Competitive Impact Statement, and any comments thereon and the United States' responses to comments. Based upon the record before the Court, which includes the Competitive Impact Statement and any comments and response to comments filed with the Court, entry of this Final Judgment is in the public interest.
This Settlement Agreement (Agreement) is entered into among the United States of America, acting through the Civil Division of the United States Department of Justice and the United States Attorney's Office for the Southern District of Ohio, on behalf of the Defense Logistics Agency (DLA) and the Army and Air Force Exchange Service (AAFES) (collectively the “United States”), SK Energy Co., Ltd. (SK Energy), and Relator [REDACTED] (hereafter collectively referred to as “the Parties”), through their authorized representatives.
A. SK Energy is a South Korea-based energy company that produces various petroleum products that it sells to South Korean and international customers, including the United States Department of Defense (DoD).
B. On February 28, 2018, Relator, a resident and citizen of South Korea, filed a
C. On such date as may be determined by the Court, SK Energy will plead guilty pursuant to Fed. R. Crim. P. 11(c)(1)(C) (the “Plea Agreement”) to an Information to be filed in
D. SK Energy will execute a Stipulation with the Antitrust Division of the United States Department of Justice in which SK Energy will consent to the entry of a Final Judgment to be filed in
E. The United States contends that it has certain civil claims against SK Energy arising from the conduct described in the Plea Agreement in the Criminal Action and in the Stipulation in the Civil Antitrust Action, as well as the conduct, actions, and claims alleged by Relator in the Civil FCA Action. The conduct referenced in this Paragraph is referred to below as the Covered Conduct.
F. With the exception of any admissions that are made by SK Energy in connection with the Plea Agreement in the Criminal Action, this Settlement Agreement is neither an admission of liability by SK Energy nor a concession by the United States that its claims are not well founded.
G. Relator claims entitlement under 31 U.S.C. § 3730(d) to a share of the proceeds of this Settlement Agreement and to Relator's reasonable expenses, attorneys' fees and costs.
To avoid the delay, uncertainty, inconvenience, and expense of protracted litigation of the above claims, and in consideration of the mutual promises and obligations of this Settlement Agreement, the Parties agree and covenant as follows:
1.a. SK Energy agrees to pay to the United States $71,866,000 (FCA Settlement Amount), of which $47,910,887 is restitution, by electronic funds transfer no later than thirteen (13) business days after the Effective Date of this Agreement pursuant to written instructions to be provided by the Civil Division of the Department of Justice. Relator claims entitlement under 31 U.S.C. § 3730(d) to Relator's reasonable expenses, attorneys' fees and costs. The FCA Settlement Amount does not include the Relator's fees and costs, and SK Energy acknowledges that Relator retains all rights to recover such expenses, attorneys' fees, and costs from SK Energy pursuant to 31 U.S.C. § 3730(d).
1.b. If SK Energy's Plea Agreement in the Criminal Action is not accepted by
2. Subject to the exceptions in Paragraph 4 (concerning excluded claims) below, and conditioned upon SK Energy's full payment of the FCA Settlement Amount, the United States releases SK Energy together with its current and former parent corporations; direct and indirect subsidiaries; brother or sister corporations; divisions; current or former corporate owners; and the corporate successors and assigns of any of them (the “SK Energy Released Parties”) from any civil or administrative monetary claim the United States has for the Covered Conduct under the False Claims Act, 31 U.S.C. §§ 3729-3733; the Program Fraud Civil Remedies Act, 31 U.S.C. §§ 3801-3812; Contract Disputes Act, 41 U.S.C. §§ 7101-7109; or the common law theories of breach of contract, payment by mistake, unjust enrichment, and fraud.
3. Except as set forth in Paragraph 1 (concerning Relator's claims under 31 U.S.C. § 3730(d)), and conditioned upon SK Energy's full payment of the FCA Settlement Amount, Relator, for himself and for his heirs, successors, attorneys, agents, and assigns, releases the SK Energy Released Parties from (a) any civil monetary claim the Relator has or may have for the claims set forth in the Civil FCA Action, the Civil Antitrust Action, the Criminal Action, and the Covered Conduct under the False Claims Act, 31 U.S.C. §§ 3729-3733, up until the date of this Agreement; and (b) all liability, claims, demands, actions, or causes of action whatsoever, whether known or unknown, fixed or contingent, in law or in equity, in contract or in tort, under any federal, state, or Korean statute, law, regulation or doctrine, that Relator, his heirs, successors, attorneys, agents, and assigns otherwise has brought or would have standing to bring as of the date of this Agreement, including any liability to Relator arising from or relating to the claims Relator asserted or could have asserted in the Civil FCA Action, up until the date of this Agreement. Relator further represents he does not know of any conduct by the SK Energy Released Parties or any current or former owners, officers, directors, trustees, shareholders, employees, executives, agents, or affiliates of the SK Energy Released Parties that would constitute a violation of the False Claims Act other than the claims set forth in the Civil FCA Action and the Covered Conduct, and Relator acknowledges and agrees that his representations are a material inducement to SK Energy's willingness to enter into this Agreement.
4. Notwithstanding the releases given in paragraphs 2 and 3 of this Agreement, or any other term of this Agreement, the following claims of the United States are specifically reserved and are not released:
a. Any liability arising under Title 26, U.S. Code (Internal Revenue Code);
b. Any criminal liability, except to the extent detailed in the Plea Agreement;
c. Except as explicitly stated in this Agreement, any administrative liability, including the suspension and debarment rights of any federal agency;
d. Any liability to the United States (or its agencies) for any conduct other than the Covered Conduct;
e. Any liability based upon obligations created by this Agreement;
f. Any liability of individuals;
g. Any liability for express or implied warranty claims or other claims for defective or deficient products or services, including quality of goods and services;
h. Any liability for failure to deliver goods or services due; and
i. Any liability for personal injury or property damage or for other consequential damages arising from the Covered Conduct.
5. Relator and his heirs, successors, attorneys, agents, and assigns shall not object to this Agreement but agree and confirm that this Agreement is fair, adequate, and reasonable under all the circumstances, pursuant to 31 U.S.C. § 3730(c)(2)(B). The determination of Relator's share, if any, of the FCA Settlement Amount pursuant to 31 U.S.C. § 3730(d) is a matter that shall be handled separately by and between the Relator and the United States, without any direct involvement or input from SK Energy. In connection with this Agreement and this Civil FCA Action, Relator, on behalf of himself and his heirs, successors, attorneys, agents, and assigns agrees that neither this Agreement, nor any intervention by the United States in the Civil FCA Action in order to dismiss the Civil FCA Action, nor any dismissal of the Civil FCA Action, shall waive or otherwise affect the ability of the United States to contend that provisions in the False Claims Act, including 31 U.S.C. § 3730(d)(3), bar Relator from sharing in the proceeds of this Agreement, except that the United States will not contend that Relator is barred from sharing in the proceeds of this Agreement pursuant to 31 U.S.C. § 3730(e)(4). Moreover, the United States and Relator, on behalf of himself and his heirs, successors, attorneys, agents, and assigns agree that they each retain all of their rights pursuant to the False Claims Act on the issue of the share percentage, if any, that Relator should receive of any proceeds of the settlement of his claims, and that no agreements concerning Relator share have been reached to date.
6. SK Energy waives and shall not assert any defenses SK Energy may have to any criminal prosecution or administrative action relating to the Covered Conduct that may be based in whole or in part on a contention that, under the Double Jeopardy Clause in the Fifth Amendment of the Constitution, or under the Excessive Fines Clause in the Eighth Amendment of the Constitution, this Agreement bars a remedy sought in such criminal prosecution or administrative action.
7. SK Energy fully and finally releases the United States, its agencies, officers, agents, employees, and servants, from any claims (including attorney's fees, costs, and expenses of every kind and however denominated) that SK Energy has asserted, could have asserted, or may assert in the future against the United States, its agencies, officers, agents, employees, and servants, related to the Covered Conduct and the United States' investigation and prosecution thereof.
8. Conditioned upon Relator's agreement herein, the SK Energy Released Parties fully and finally release Relator his heirs, successors, assigns, agents and attorneys (the “Relator Released Parties”), from (a) any civil monetary claim SK Energy has or may have now or in the future against the Relator Released Parties related to the claims set forth in the Civil FCA Action, the Civil Antitrust Action, the Criminal Action, and the Covered Conduct under the False Claims Act, 31 U.S.C. §§ 3729-3733, and the Relator's investigation and prosecution thereof, including
9.a. Unallowable Costs Defined: All costs (as defined in the Federal Acquisition Regulation, 48 C.F.R. § 31.205-47) incurred by or on behalf of SK Energy, and its present or former officers, directors, employees, shareholders, and agents in connection with:
(1) the matters covered by this Agreement, any related plea agreement, and any related civil antitrust agreement;
(2) the United States' audit(s) and civil and any criminal investigation(s) of the matters covered by this Agreement;
(3) SK Energy's investigation, defense, and corrective actions undertaken in response to the United States' audit(s) and civil and any criminal investigation(s) in connection with the matters covered by this Agreement (including attorney's fees);
(4) the negotiation and performance of this Agreement, any related plea agreement, and any related civil antitrust agreement;
(5) the payment SK Energy makes to the United States pursuant to this Agreement and any payments that SK Energy may make to Relator, including costs and attorneys' fees,
b. Future Treatment of Unallowable Costs: Unallowable Costs will be separately determined and accounted for by SK Energy, and SK Energy shall not charge such Unallowable Costs directly or indirectly to any contract with the United States.
c. Treatment of Unallowable Costs Previously Submitted for Payment: Within 90 days of the Effective Date of this Agreement, SK Energy shall identify and repay by adjustment to future claims for payment or otherwise any Unallowable Costs included in payments previously sought by SK Energy or any of its subsidiaries or affiliates from the United States. SK Energy agrees that the United States, at a minimum, shall be entitled to recoup from SK Energy any overpayment plus applicable interest and penalties as a result of the inclusion of such Unallowable Costs on previously-submitted requests for payment. The United States, including the Department of Justice and/or the affected agencies, reserves its rights to audit, examine, or re-examine SK Energy's books and records and to disagree with any calculations submitted by SK Energy or any of its subsidiaries or affiliates regarding any Unallowable Costs included in payments previously sought by SK Energy, or the effect of any such Unallowable Costs on the amount of such payments.
10. SK Energy agrees to cooperate fully and truthfully with the United States in connection with the Civil FCA Action. The Civil Division of the United States Department of Justice will use reasonable best efforts, where appropriate, to coordinate any requests for cooperation in connection with the Civil FCA Action with requests for cooperation in connection with the Plea Agreement in the Criminal Action and the Civil Antitrust Action, so as to avoid unnecessary duplication and expense. SK Energy's ongoing, full, and truthful cooperation shall include, but not be limited to:
a. upon request by the United States with reasonable notice, producing at the offices of counsel for the United States in Washington, D.C. and not at the expense of the United States, complete and un-redacted copies of all non-privileged documents related to the Covered Conduct wherever located in SK Energy's possession, custody, or control, including but not limited to, reports, memoranda of interviews, and records concerning any investigation of the Covered Conduct that SK Energy has undertaken, or that has been performed by another on SK Energy's behalf;
b. upon request by the United States with reasonable notice, making current SK Energy directors, officers, and employees available for interviews, consistent with the rights and privileges of such individuals, by counsel for the United States and/or their investigative agents, not at the expense of the United States, in the United States or Hong Kong, unless another place is mutually agreed upon;
c. upon request by the United States with reasonable notice, (i) using best efforts to assist in locating former SK Energy directors, officers, and employees identified by attorneys and/or investigative agents of the United States, and (ii) using best efforts to make any such former SK Energy directors, officers, and employees available for interviews, consistent with the rights and privileges of such individuals, by counsel for the United States and/or their investigative agents, not at the expense of the United States, in the United States or Hong Kong, unless another place is mutually agreed upon; and
d. upon request by the United States with reasonable notice, making current SK Energy directors, officers, and employees available, and using best efforts to make former SK Energy directors, officers, employees available, to testify, consistent with the rights and privileges of such individuals, fully, truthfully, and under oath, without falsely implicating any person or withholding any information, (i) at depositions in the United States, Hong Kong, or any other mutually agreed upon place, (ii) at trial in the United States, and (iii) at any other judicial proceedings wherever located related to the Civil FCA Action.
11. This Agreement is intended to be for the benefit of the Parties only.
12. Upon receipt of the payment of the FCA Settlement Amount described in Paragraph 1 above, the Court's acceptance of SK Energy's Plea Agreement in the Criminal Action, and the Court's entry of a Final Judgment in the Civil Antitrust Action, the United States and Relator shall promptly sign and file a Joint Stipulation of Dismissal, with prejudice, of the claims filed against SK Energy in the Civil FCA Action, pursuant to Rule 41(a)(1), which dismissal shall be conditioned on the Court retaining jurisdiction over Relator's claims to a relator's share and recovery of attorneys' fees and costs pursuant to 31 U.S.C. § 3730(d).
13. Except with respect to the recovery of Relator's attorneys' fees, expenses, and costs pursuant to 31 U.S.C. § 3730(d), each Party shall bear its own legal and other costs incurred in connection with this matter. The Parties agree that Relator and SK Energy will not seek to recover from the United States any costs or fees related to the preparation and performance of this Agreement.
14. Each party and signatory to this Agreement represents that it freely and voluntarily enters in to this Agreement without any degree of duress or compulsion.
15. This Agreement is governed by the laws of the United States. The exclusive
16. This Agreement constitutes the complete agreement between the Parties on the subject matter addressed herein. This Agreement may not be amended except by written consent of the Parties.
17. The undersigned counsel represent and warrant that they are fully authorized to execute this Agreement on behalf of the persons and entities indicated below.
18. This Agreement may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same Agreement.
19. This Agreement is binding on SK Energy's successors, transferees, heirs, and assigns.
20. This Agreement is binding on Relator's successors, transferees, heirs, and assigns.
21. All parties consent to the United States' disclosure of this Agreement, and information about this Agreement, to the public, as permitted by order of the Court. This Agreement shall not be released in un-redacted form until the Court unseals the entire Civil FCA Action.
22. This Agreement is effective on the date of signature of the last signatory to the Agreement (Effective Date of this Agreement). Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this Agreement.
Plaintiff United States of America, pursuant to Section 2(b) of the Antitrust Procedures and Penalties Act (“APPA” or “Tunney Act”), 15 U.S.C. § 16(b)-(h), files this Competitive Impact Statement relating to the proposed Final Judgments submitted for entry in this civil antitrust proceeding.
On November 14, 2018, the United States filed a civil antitrust complaint against Defendants GS Caltex Corporation (“GS Caltex”), Hanjin Transportation Co., Ltd. (“Hanjin”), and SK Energy Co., Ltd. (“SK Energy”) alleging that Defendants violated Section 1 of the Sherman Act, 15 U.S.C. § 1. From at least March 2005 and continuing until at least October 2016 (“the Relevant Period”), Defendants and their co-conspirators conspired to fix prices and rig bids for the supply of fuel to the U.S. military for its operations in South Korea. As a result of this illegal conduct, Defendants and their co-conspirators overcharged American taxpayers by well over $100 million. Defendants have agreed to plead guilty to an information charging a criminal violation of Section 1 of the Sherman Act for this unlawful conduct; in this parallel civil action, the United States seeks compensation for the injury it incurred as a result of the conspiracy.
At the same time the Complaint was filed, the United States also filed agreed-upon proposed Final Judgments that would remedy the violation by having GS Caltex, Hanjin, and SK Energy pay $57,500,000, $6,182,000, and $90,384,872, respectively, to the United States. These payments resolve all civil claims of the United States related to the conduct described in the Complaint. The United States and Defendants have stipulated that the proposed Final Judgments may be entered after compliance with the APPA. Entry of the proposed Final Judgments would terminate this action, except that the Court would retain jurisdiction to construe, modify, or enforce the provisions of the proposed Final Judgments and to punish violations thereof.
GS Caltex is an oil company headquartered in Seoul, South Korea. GS Caltex is a joint venture between GS Energy, a South Korean corporation, and Chevron Corp., a Delaware corporation, which each own a 50 percent interest in GS Caltex. GS Caltex is engaged in the refining and supply of gasoline, diesel, kerosene, and other petroleum products for sale internationally. During the time of the conspiracy, GS Caltex supplied fuel to U.S. military installations in South Korea.
Hanjin is a global transportation and logistics company based in Seoul, South Korea. Hanjin is a member of Hanjin Group, a South Korean conglomerate with U.S. subsidiaries, including Hanjin International America. Beginning in 2009, Hanjin partnered with oil companies, including a co-conspirator oil company (“Company A”), to supply fuel to U.S. military installations in South Korea.
SK Energy is an oil company headquartered in Seoul, South Korea. SK Energy is engaged in the refining and supply of gasoline, diesel, kerosene, and other petroleum products for sale internationally. During the time of the conspiracy, SK Energy supplied fuel to U.S. military installations in South Korea.
Other persons, not named as defendants in this action, participated as co-conspirators in the violation alleged in the Complaint and performed acts and made statements in furtherance thereof. These co-conspirators included, among others, a logistics firm (“Company B”) and an oil company (“Company C”) that jointly supplied fuel to the U.S. military.
The United States military procures fuel for its installations in South Korea through competitive solicitation processes. Oil companies, either independently or with a transportation company, submitted bids in response to these solicitations.
The conduct at issue in this action relates to two types of contracts to supply fuel to the U.S. military in South Korea: Post, Camps, and Stations (“PC&S”) contracts and Army and Air Force Exchange Services (“AAFES”) contracts.
PC&S contracts are issued and administered by the Defense Logistics Agency (“DLA”), a combat support agency of the U.S. Department of Defense. The fuel procured under PC&S contracts is used to power military vehicles and heat U.S. military buildings. During the Relevant Period, DLA issued PC&S solicitations listing the fuel requirements for installations across South Korea, with each delivery location identified by a separate line item. Bidders submitted initial bids, offering a price for each line item on which they chose to bid. After DLA reviewed the initial bids, bidders were allowed to submit revised final bids. DLA reviewed the bids and awarded contracts to the bidders offering the lowest price for each line item. Payments under the PC&S contracts were wired to the awardees by a finance and accounting agency of the U.S. Department of Defense from its office in Columbus, Ohio.
AAFES is an agency of the Department of Defense headquartered in Dallas, Texas. AAFES operates official retail stores (known as “exchanges”) on U.S. Army and Air Force installations worldwide, which U.S. military personnel and their families use to purchase everyday goods and services, including gasoline for use in their personal vehicles. AAFES procures fuel for these stores via contracts awarded through a competitive solicitation process.
In 2008, AAFES issued a solicitation that listed the fuel requirements for installations in South Korea. Bidders submitted bids offering a price for each line item in the solicitation. Unlike DLA, AAFES awarded the entire 2008 contract to the bidder offering the lowest price across all the listed locations.
The Complaint alleges that Defendants and their co-conspirators engaged in a series of meetings, telephone conversations, e-mails, and other communications to rig bids and fix prices for the supply of fuel to U.S. military installations in South Korea under several PC&S and AAFES contracts.
First, the Complaint alleges that GS Caltex, SK Energy, and Companies B and C conspired to rig bids and fix prices on the contracts issued in response to DLA solicitations SP0600-05-R-0063 and SP0600-05-R-0063-0001 (“2006 PC&S contracts”). The term of the 2006 PC&S contracts covered the supply of fuel from February 2006 through July 2009.
The Complaint alleges that between early 2005 and mid-2006, GS Caltex, SK Energy, and other conspirators met multiple times and exchanged phone calls and e-mails to allocate the line items in the solicitations for the 2006 PC&S contracts. Through such communications, these conspirators agreed to inflate their bids to produce larger profit margins. For each line item allocated to a different co-conspirator, the other conspirators agreed not to bid or to bid high enough to ensure that they would not win that item. DLA awarded the 2006 PC&S line items according to the allocations made by the conspiracy.
Second, the Complaint alleges that, as part of their discussions related to the 2006 PC&S contracts, GS Caltex and other conspirators agreed not to compete with SK Energy in bidding for the June 2008 AAFES solicitation (“2008 AAFES contract”). The initial term of the 2008 AAFES contract ran from July 2008 to July 2010; the contract was later extended through July 2013.
Third, the Complaint alleges that Defendants and other co-conspirators conspired to rig bids and fix prices for the contracts issued in response to DLA solicitation SP0600-08-R-0233 (“2009 PC&S contracts”). Hanjin and Company A joined the conspiracy for the purpose of bidding on SP0600-08-R-0233. The term of the 2009 PC&S contracts covered the supply of fuel from October 2009 through August 2013.
The Complaint explains that between late 2008 and mid-2009, Defendants and other co-conspirators met multiple times and exchanged phone calls and e-mails to allocate the line items in the solicitation for the 2009 PC&S contracts. As in 2006, these conspirators agreed to bid high so as to not win line items allocated to other co-conspirators. The original conspirators agreed to allocate to Hanjin and Company A certain line items that had previously been allocated to the original conspirators.
Finally, the Complaint alleges that Defendants and other co-conspirators once again conspired to rig bids and fix prices for the contracts issued in response to DLA solicitation SP0600-12-R-0332 (“2013 PC&S contracts”). The term of the 2013 PC&S contracts covered the supply of fuel from August 2013 through July 2016.
The Complaint explains that Defendants and other co-conspirators communicated via phone calls and e-mails to allocate and set the price for each line item in the solicitation for the 2013 PC&S contracts. Defendants and other co-conspirators believed that they had an agreement as to their bidding strategy and pricing for the 2013 PC&S contracts. As a result of this agreement, they submitted bids with pricing above what they would have offered absent collusion.
Hanjin and Company A submitted bids for the 2013 PC&S contracts below the prices set by the other co-conspirators, however. Although lower than the pricing agreed upon by the conspirators, Hanjin and Company A still submitted bids above a competitive, non-collusive price, knowing that they would likely win the contracts because the other conspirators would bid even higher prices.
For violations of Section 1 of the Sherman Act, the United States may seek damages, 15 U.S.C. § 15a, and equitable relief, 15 U.S.C. § 4, including equitable monetary remedies.
This action is also related to a
The proposed Final Judgments require GS Caltex, Hanjin, and SK Energy respectively to pay $57,500,000, $6,182,000, and $90,384,872 to the United States within 10 business days of entry of the Final Judgment. These payments will satisfy all civil claims arising from the events described in Section II
As a result of the unlawful agreements in restraint of trade between Defendants and their co-conspirators, the United States paid more for the supply of fuel to U.S. military installations in South Korea than it would have if the companies had engaged in fair and honest competition. Defendants' payments under the proposed Final
Under Section 4A of the Clayton Act, the United States is entitled to treble damages for injuries it has suffered as a result of violations of the Sherman Act. Under the proposed Final Judgments, each Defendant will pay an amount that exceeds the overcharge but that reflects the value of the cooperation commitments the Defendants have made as a condition of settlement and the cost savings realized by avoiding extended litigation.
The proposed Final Judgments also require each Defendant to appoint an Antitrust Compliance Officer and to institute an antitrust compliance program. Under the antitrust compliance program, employees and directors of Defendants with responsibility for bidding on contracts with the United States must undergo training and all employees must be informed that there will no reprisal for disclosing to the Antitrust Compliance Officer any potential violations of the United States antitrust laws. The Antitrust Compliance Officer is required annually to certify that Defendant is in compliance with this requirement.
The proposed Final Judgments contain provisions designed to promote compliance and make the enforcement of Division consent decrees as effective as possible. Paragraph VII(A) provides that the United States retains and reserves all rights to enforce the provisions of the proposed Final Judgments, including its rights to seek an order of contempt from the Court. Defendants have agreed that in any civil contempt action, any motion to show cause, or any similar action brought by the United States regarding an alleged violation of the Final Judgments, the United States may establish the violation and the appropriateness of any remedy by a preponderance of the evidence and that the Defendants have waived any argument that a different standard of proof should apply. This provision aligns the standard for compliance obligations with the standard of proof that applies to the underlying offense that the compliance commitments address.
Paragraph VII(B) provides additional clarification regarding the interpretation of the provisions of the proposed Final Judgments. The proposed Final Judgments were drafted to restore all competition the United States alleged was harmed by the Defendants' challenged conduct. The Defendants agree that they will abide by the proposed Final Judgments, and that they may be held in contempt of this Court for failing to comply with any provision of the proposed Final Judgments that is stated specifically and in reasonable detail, as interpreted in light of this procompetitive purpose.
Paragraph VII(C) further provides that should the Court find in an enforcement proceeding that a Defendant has violated the Final Judgment, the United States may apply to the Court for a one-time extension of the Final Judgment, together with such other relief as may be appropriate. In addition, in order to compensate American taxpayers for any costs associated with the investigation and enforcement of violations of a proposed Final Judgment, Paragraph VII(C) provides that in any successful effort by the United States to enforce a Final Judgment against a Defendant, whether litigated or resolved before litigation, Defendants agree to reimburse the United States for any attorneys' fees, experts' fees, or costs incurred in connection with any enforcement effort, including the investigation of the potential violation.
Finally, Section VIII of the proposed Final Judgments provide that each Final Judgment shall expire seven years from the date of its entry, except that after five years from the date of its entry, a Final Judgment may be terminated upon notice by the United States to the Court and the Defendant that the continuation of that Final Judgment is no longer necessary or in the public interest.
Entry of the proposed Final Judgments will neither impair nor assist the bringing of any private antitrust damages action. Under the provisions of Section 5(a) of the Clayton Act, 15 U.S.C. § 16(a), the proposed Final Judgments have no prima facie effect in any subsequent lawsuit that may be brought against Defendants.
The United States and Defendants have stipulated that the proposed Final Judgments may be entered by the Court after compliance with the provisions of the APPA, provided that the United States has not withdrawn its consent. The APPA conditions entry upon the Court's determination that the proposed Final Judgments are in the public interest.
The APPA provides a period of at least sixty (60) days preceding the effective date of the proposed Final Judgments within which any person may submit to the United States written comments regarding a proposed Final Judgment. Any person who wishes to comment should do so within sixty (60) days of the date of publication of this Competitive Impact Statement in the
Written comments should be submitted by mail to:
The proposed Final Judgments provide that the Court retains jurisdiction over this action, and the parties may apply to the Court for any necessary or appropriate modification, interpretation, or enforcement of a Final Judgment.
The United States considered, as an alternative to the proposed Final Judgments, a full trial on the merits against Defendants. The United States is satisfied, however, that the relief in the proposed Final Judgments remedies the violation of the Sherman Act alleged in the Complaint. The proposed Final
The Clayton Act, as amended by the APPA, requires that proposed consent judgments in antitrust cases brought by the United States be subject to a 60-day comment period, after which the court shall determine whether entry of the proposed Final Judgment “is in the public interest.” 15 U.S.C. § 16(e)(1). In making that determination, the court, in accordance with the statute as amended in 2004, is required to consider:
(A) the competitive impact of such judgment, including termination of alleged violations, provisions for enforcement and modification, duration of relief sought, anticipated effects of alternative remedies actually considered, whether its terms are ambiguous, and any other competitive considerations bearing upon the adequacy of such judgment that the court deems necessary to a determination of whether the consent judgment is in the public interest; and
(B) the impact of entry of such judgment upon competition in the relevant market or markets, upon the public generally and individuals alleging specific injury from the violations set forth in the complaint including consideration of the public benefit, if any, to be derived from a determination of the issues at trial.
Under the APPA a court considers, among other things, the relationship between the remedy secured and the specific allegations in the government's complaint, whether the decree is sufficiently clear, whether its enforcement mechanisms are sufficient, and whether the decree may positively harm third parties.
[t]he balancing of competing social and political interests affected by a proposed antitrust consent decree must be left, in the first instance, to the discretion of the Attorney General. The court's role in protecting the public interest is one of insuring that the government has not breached its duty to the public in consenting to the decree. The court is required to determine not whether a particular decree is the one that will best serve society, but whether the settlement is “
In determining whether a proposed settlement is in the public interest, a district court “must accord deference to the government's predictions about the efficacy of its remedies, and may not require that the remedies perfectly match the alleged violations.”
Moreover, the court's role under the APPA is limited to reviewing the remedy in relationship to the violations that the United States has alleged in its complaint, and does not authorize the court to “construct [its] own hypothetical case and then evaluate the decree against that case.”
In its 2004 amendments,
There are no determinative materials or documents within the meaning of the APPA that were considered by the United States in formulating the proposed Final Judgment.
| 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 |