        DEPARTMENT OF HEALTH AND HUMAN SERVICES
        Centers for Medicare & Medicaid Services
        42 CFR Part 513
        [CMS-5528-P]
        RIN 0938-AT91
        Most Favored Nation (MFN) Model

          AGENCY:
          Centers for Medicare & Medicaid Services (CMS), HHS.

          ACTION:
          Proposed rule.

          SUMMARY:

          This proposed rule proposes to rescind the Most Favored Nation Model interim final rule with comment period that appeared in the November 27, 2020, Federal Register.

          DATES:
          To be assured consideration, comments must be received at one of the addresses provided below, by October 12, 2021.

          ADDRESSES:
          In commenting, please refer to file code CMS-5528-P.

          Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):
          1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions.
          2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-5528-P, P.O. Box 8013, Baltimore, MD 21244-8013.
          Please allow sufficient time for mailed comments to be received before the close of the comment period.
          3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-5528-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

          For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

          FOR FURTHER INFORMATION CONTACT:
          Lara Strawbridge, (410) 786-7400 or MFN@cms.hhs.gov.

        SUPPLEMENTARY INFORMATION:

          Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to view public comments. CMS will not post on Regulations.gov public comments that make threats to individuals or institutions or suggest that the individual will take actions to harm any individual. CMS continues to encourage individuals not to submit duplicative comments. We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments.
        I. Background
        Increases in Part B prescription drug spending significantly outpace the growth in spending on other Medicare Part B services,1

           and prices in the United States (U.S.) for most Medicare Part B drugs with the highest Medicare spending far exceed prices in other countries.2 3
           Specifically, drugs have consistently been a major contributor to the overall Medicare Part B spending trend. Medicare Part B fee-for-service (FFS) spending for separately payable physician-administered drugs and drugs furnished in a hospital outpatient department represented about 11 percent of Medicare Part B FFS benefit spending in 2015, but accounted for about 37 percent of the change in Medicare Part B FFS benefit spending from 2015 to 2020.4
           In addition to the continued growth in spending, Medicare pays substantially more than other countries for many of the highest-cost Medicare Part B drugs that beneficiaries receive in an outpatient setting for which Medicare Part B allows separate payment.5
           In many instances, Medicare pays more than twice as much for certain drugs as other countries do.6

            1 Nguyen X. Nguyen and Steve Sheingold. Medicare Part B Drugs: Trends in Spending and Utilization, 2006-2017. Washington, DC: Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services. November 20, 2020 (https://aspe.hhs.gov/pdf-report/medicare-part-b-drugs-spending-and-utilization).

            2  “Comparison of U.S. and International Prices for Top Medicare Part B Drugs by Total Expenditures” accessed via https://aspe.hhs.gov/pdf-report/comparison-us-and-international-prices-top-medicare-part-b-drugs-total-expenditures; El-Kilani Z, Finegold K, Mulcahy A, and Bosworth A. Medicare FFS Part B and International Drug Prices: A Comparison of the Top 50 Drugs. Washington, DC: Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services. November 20, 2020 (https://aspe.hhs.gov/pdf-report/medicare-ffs-part-b-and-international-drug-prices).

            3 Individual countries differ in the regulatory processes and standards governing approval of drugs and biologicals. Use of international drug prices in the MFN Model should not be interpreted to connote FDA approval or to otherwise describe any scientific or regulatory relationship between U.S.-approved and non-U.S.-approved products.

            4 2020 Annual Report of the Boards of Trustees of the Federal Hospital Insurance and Federal Supplementary Medical Insurance Trust Funds. Accessed via: https://www.cms.gov/files/document/2020-medicare-trustees-report.pdf.

            5  “Comparison of U.S. and International Prices for Top Medicare Part B Drugs by Total Expenditures” accessed via https://aspe.hhs.gov/pdf-report/comparison-us-and-international-prices-top-medicare-part-b-drugs-total-expenditures; El-Kilani Z, Finegold K, Mulcahy A, and Bosworth A. Medicare FFS Part B and International Drug Prices: A Comparison of the Top 50 Drugs. Washington, DC: Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services. November 20, 2020 (https://aspe.hhs.gov/pdf-report/medicare-ffs-part-b-and-international-drug-prices).

            6 “Comparison of U.S. and International Prices for Top Medicare Part B Drugs by Total Expenditures” accessed via https://aspe.hhs.gov/pdf-report/comparison-us-and-international-prices-top-medicare-part-b-drugs-total-expenditures; El-Kilani Z, Finegold K, Mulcahy A, Bosworth A. Medicare FFS Part B and International Drug Prices: A Comparison of the Top 50 Drugs. Washington, DC: Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services. November 20, 2020 (https://aspe.hhs.gov/pdf-report/medicare-ffs-part-b-and-international-drug-prices).

        This imbalance in payment arises because Medicare generally establishes the payment for separately payable Medicare Part B drugs using the methodology in section 1847A of the Social Security Act (the Act). In most cases, this means payment is based on the average sales price (ASP) plus a statutorily mandated 6 percent add-on. Under this methodology, the Medicare program does not get the benefit of the substantial discounts provided in other countries, because ASP is calculated using only the prices that manufacturers charge to certain U.S.-based purchasers. ASP-based payments may also encourage the use of more expensive drugs because the dollar amount of the 6 percent add-on portion is larger for drugs with higher ASPs.7

            7 MedPAC, June 2017, “Medicare Part B Drug Payment Policy Issues,” accessed via http://medpac.gov/docs/default-source/reports/jun17_ch2.pdf

        The Most Favored Nation (MFN) Model interim final rule with comment period (85 FR 76180) 8

           (hereafter, referred to as “the November 2020 interim final rule”) was published in the Federal Register on November 27, 2020, and was effective the same day, with a 60-day comment period. The 60-day comment period on the November 2020 interim final rule closed on January 26, 2021. The November 2020 interim final rule established a 7-year nationwide, mandatory MFN Model, under section 1115A of the Act, with the model performance period beginning on January 1, 2021. The MFN Model would test an alternative way for Medicare to pay for certain Medicare Part B single source drugs and biologicals (including biosimilar biologicals). For additional information on the MFN Model, see the November 2020 interim final rule and the MFN Model website.9

            8 Available at https://www.govinfo.gov/content/pkg/FR-2020-11-27/pdf/2020-26037.pdf.

            9 Available at https://innovation.cms.gov/innovation-models/most-favored-nation-model.

        In the November 2020 interim final rule, Waiver of Proposed Rulemaking and Delay in Effective Date, we stated that we found that there was good cause to waive the notice and comment requirements under sections 553(b)(B) of the Administrative Procedure Act and section 1871(b)(2)(C) of the Act because of the particularly acute need for affordable Medicare Part B drugs in the midst of the COVID-19 pandemic (85 FR 76249).

        In December 2020, while the comment period was open, four lawsuits were filed related to CMS's waivers of proposed rulemaking and delay in effective date as well as other aspects of the MFN Model and the November 2020 interim final rule: Association of Community Cancer Centers v. Azar, No. 8:20-cv-03531 (D. Md.); California Life Sciences Ass'n v. CMS, No. 3:20-cv-08603 (N.D. Ca); Regeneron Pharmaceuticals v. HHS, No. 7:20-cv-10488 (S.D.N.Y.); and Community Oncology Alliance, Inc. v. HHS, No.1:20-cv-03604 (D.D.C.). On December 28, 2020, the U.S. District Court for the Northern District of California issued a nationwide preliminary injunction in California Life Sciences, which preliminarily enjoined HHS from implementing the MFN Model and the November 2020 interim final rule. The lawsuits in the U.S. District Court for the District of Maryland and the U.S. District Court for the District of Columbia were stayed based on the nationwide preliminary injunction. On December 30, 2020, the U.S. District Court for the Southern District of New York issued a preliminary injunction in Regeneron Pharmaceuticals v. HHS, which preliminarily enjoined HHS from applying the November 2020 interim final rule to Regeneron's drug EYLEA® (aflibercept).

        On January 8, 2021, the Solicitor General determined not to appeal the preliminary injunction issued in California Life Sciences. On January 19, 2021, at the parties' request, the U.S. Northern District of California stayed the case until at least April 23, 2021. Subsequently, on April 26, 2021, another stay was granted until July 26, 2021. On July 29, 2021, another stay was granted until September 27, 2021.
        In Regeneron Pharmaceuticals, on February 2, 2021, the plaintiff filed a letter seeking leave to file a motion for summary judgment, and HHS filed a letter seeking leave to file a motion for a stay. On February 10, 2021, the U.S. District Court for the Southern District of New York granted HHS's request and stayed the case for 90 days (that is, through May 11, 2021). On May 10, 2021, the stay in this case was extended for an additional 90 days, until August 9, 2021, to give HHS time to consider how to proceed with the rule in light of the “unanimous” court decisions to date. In its order, the court noted that HHS should “not assume that another stay will be granted,” as the stays gave HHS “a half-year to reach a conclusion regarding how to proceed[.]”
        As a result of the nationwide preliminary injunction, the MFN Model was not implemented on January 1, 2021, as contemplated in the November 2020 interim final rule. While the nationwide preliminary injunction has been in place, CMS considered how to proceed given stakeholders' concerns about potential impacts of the MFN Model.
        II. Provisions of the Proposed Regulations
        We received approximately 1,166 timely pieces of correspondence in response to the November 2020 interim final rule. We appreciate the comments that we received. We note that many commenters agreed with HHS about the urgency of addressing high prescription drug prices, but nearly all of the commenters expressed concern about beginning the model on January 1, 2021, including starting the model during the COVID-19 pandemic. Given that the nationwide preliminary injunction precluded implementation of the MFN Model on January 1, 2021, as contemplated, that multiple courts found procedural issues with the November 2020 interim final rule, and that stakeholders expressed concern about the model start date,10
           we are proposing to rescind regulations added by the November 2020 interim final rule and remove the associated regulatory text at 42 CFR part 513. We believe this proposed rule communicates how we wish to proceed with the November 2020 interim final rule to the courts and the public. Since the preliminary injunctions prevented the November 2020 interim final rule from taking effect, we do not believe there would be any disruption to reliance interests or Medicare program administration if this proposed rule were to take effect. If finalized, our proposal would allow us to take time to further consider the issues identified by commenters and would address the November 2020 interim final rule's procedural deficiencies by rescinding it. We note that this proposed rule (that is, our proposal to effectively withdraw an interim final rule with comment period) is limited to the codification of the November 2020 interim final rule, and does not reflect any judgment by HHS regarding future policy.

            10 For example, commenters stated that the MFN Model should not start during the COVID-19 pandemic, and in addition that the model should not begin on January 1, 2021, while the public comment period for the November 2020 interim final rule was ongoing (until January 26, 2021). Further, commenters stated that CMS failed to allow MFN participants sufficient time to prepare for model start and to develop and deploy new systems with distributors and customers to exclude model sales from ASP reporting.

        On July 9, 2021, President Biden signed an Executive Order on Promoting Competition in the American Economy that, in part, directs the Secretary of HHS to take steps to lower the prices of and improve access to prescription drugs and biologicals. HHS is exploring opportunities to promote value-based care for our beneficiaries; to address the high cost of Medicare Part B drugs, manufacturers' pricing, and the resulting growth in Medicare Part B drug spending; and to modernize the Medicare program to improve the quality and cost of care for beneficiaries. We will continue to carefully consider the comments we received on the November 2020 interim final rule as we explore all options to incorporate value into payments for Medicare Part B drugs and improve beneficiaries' access to evidence-based care.
        We invite comments on our proposal to rescind and remove the regulations at 42 CFR part 513, which also would withdraw the MFN Model.
        III. Collection of Information Requirements

        As stated in section 1115A(d)(3) of the Act, Chapter 35 of title 44, United States Code, shall not apply to the testing and evaluation of CMS Innovation Center Models. However, costs incurred through information collections were described in sections III.H., III.I.b., and VI.C.5. of the November 2020 interim final rule (85 FR 76221, 76222, and 76244, respectively) . If this proposed rule is finalized, requirements related to the information collection described in the November 2020 interim final rule would not continue. As such, resulting savings are included in the estimate of the impact of our proposal to withdraw the MFN Model in section V.C. of this proposed rule. Further, this proposed rule does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
        IV. Response to Comments

        Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.
        V. Regulatory Impact Analysis
        A. Statement of Need

        The purpose of this proposed rule is to propose the rescission of the Most Favored Nation Model, codified by an interim final rule with comment period that appeared in the November 27, 2020 Federal Register, and remove the associated regulatory text at 42 CFR part 513, which also would withdraw the MFN Model.
        B. Overall Impact
        We have examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)).
        Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule: (1) Having an annual effect on the economy of $100 million or more in any one year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as “economically significant”); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.
        A regulatory impact analysis (RIA) must be prepared for major rules with significant regulatory actions or with economically significant effects ($100 million or more in any 1 year). Based on our estimates, OMB's Office of Information and Regulatory Affairs has determined this rulemaking is “economically significant” as measured by the $100 million threshold. Accordingly, we have prepared an RIA that to the best of our ability presents the costs and benefits of the rulemaking.
        C. Detailed Economic Analysis
        Removing the regulatory text at 42 CFR part 513, which also would withdraw the MFN Model, would mean that the annualized/monetarized estimates of costs and transfers presented in the November 2020 interim final rule (85 FR 76235 through 76248) would not be realized. The regulatory impact analysis of the November 2020 interim final rule estimated that the MFN Model would result in substantial overall savings for the Medicare program, the Medicaid program, and beneficiaries, and that model participants would experience costs associated with complying with the regulations, survey completion, and potential requests for financial hardship exemption.
        In the November 2020 interim final rule, we presented estimates from the CMS Office of the Actuary (OACT) (85 FR 76236) and the HHS Office of the Assistant Secretary for Planning and Evaluation (ASPE) (85 FR 76240). We noted that there is much uncertainty around the assumptions for both the OACT and ASPE estimates, and refer readers to section VI.C. of the November 2020 interim final rule for a more complete discussion of the estimated impacts of the MFN Model. These potential impacts were estimated to occur beginning January 2021 through December 2028, in alignment with a January 1, 2021 model start. However, because the MFN Model was not implemented on January 1, 2021, as contemplated in the November 2020 interim final rule, such effects have not occurred.
        Nevertheless and notwithstanding the nationwide preliminary injunction, this analysis uses a baseline in which the November 2020 interim final rule was implemented on January 1, 2021, to calculate the monetized estimates of the effects of this proposed rule. We maintain the analytical approach described in the regulatory impact analysis of the November 2020 interim final rule, and for the purpose of quantifying the effects of this proposed rule, assume that the regulations added by the November 2020 interim final rule will be in full effect if this proposed rule is not finalized. As a result of the rescission of the regulations added by the November 2020 interim final rule, this proposed rule would, if finalized, prevent the occurrence of the estimated costs and transfers presented in the November 2020 interim final rule. We summarize this result in Tables 1 and 2, which illustrate, inversely, the monetized estimates contained in Table 17 (85 FR 76247) and Table 18 (85 FR 76248) of the November 2020 interim final rule. The period covered shown in Tables 1 and 2 begins January 2021 in alignment with the accounting statements and tables presented in the November 2020 interim final rule. This approach illustrates that this proposed rule, if finalized, would prevent the realization of the annualized/monetarized estimates of costs and transfers that were presented in the November 2020 interim final rule. Because the MFN Model was not implemented, readers should understand that this proposed rule does not affect conditions in the past.

          Table 1—Accounting Statement: Estimated Impacts From CY 2021 to CY 2028 as a Result of Provisions of This Proposed Rule Based on the OACT Estimate

            Category
            Estimates
            Units
            Year dollar
            Discount rate(%)

            Period covered

            Costs:

            Annualized Monetized ($million/year)
            −29.4
            2018
            7
            January 2021—December 2028.

            −27.1
            2018
            3
            January 2021—December 2028.

            To Whom
            Hospital/physicians.

            Annualized Monetized ($million/year)
            −0.4
            2018
            7
            January 2021—December 2027.

            −0.4
            2018
            3
            January 2021—December 2027.

            Transfers:

            Annualized Monetized ($million/year)
            11,502.5
            2018
            7
            January 2021—December 2027.

            11,906.3
            2018
            3
            January 2021—December 2027.

            From Whom to Whom
            Federal Government to hospitals/physicians and MA plans.

            Annualized Monetized ($million/year)
            4,087.2
            2018
            7
            January 2021—December 2027.

            4,228.3
            2018
            3
            January 2021—December 2027.

            From Whom to Whom
            Beneficiaries to hospitals/physicians and MA plans.

            Annualized Monetized ($million/year)
            577.5
            2018
            7
            January 2021—December 2027.

            596.5
            2018
            3
            January 2021—December 2027.

            From Whom to Whom
            States to hospitals/physicians and MA plans.

          Table 2—Accounting Statement: Estimated Impacts From CY 2021 to CY 2028 as a Result of the Provisions of This Proposed Rule Based on the ASPE Estimate

            Category
            Estimates
            Units
            Year dollar
            Discount rate(%)

            Period covered

            Costs:

            Annualized Monetized ($million/year)
            −29.4
            2018
            7
            January 2021—December 2028.

            −27.1
            2018
            3
            January 2021—December 2028.

            To Whom
            Hospital/physicians

            Annualized Monetized ($million/year)
            −0.4
            2018
            7
            January 2021—December 2027.

            −0.4
            2018
            3
            January 2021—December 2027.

            Transfers:

            Annualized Monetized ($million/year)
            7,058.3
            2018
            7
            January 2021—December 2027.

            7,276.5
            2018
            3
            January 2021—December 2027.

            From Whom to Whom
            Federal Government to hospitals/physicians and MA plans

            Annualized Monetized ($million/year)
            4,504.9
            2018
            7
            January 2021—December 2027.

            4,638.6
            2018
            3
            January 2021—December 2027.

            From Whom to Whom
            Beneficiaries to hospitals/physicians and MA plans

            Annualized Monetized ($million/year)
            342.4
            2018
            7
            January 2021—December 2027.

            351.6
            2018
            3
            January 2021—December 2027.

            From Whom to Whom
            States to hospitals/physicians and MA plans

        D. Regulatory Flexibility Act (RFA)

        The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $8 million to $41.5 million in any 1 year. Individuals and states are not included in the definition of a small entity. For details, see the Small Business Administration's “Table of Small Business Size Standards” at https://www.sba.gov/document/support--table-size-standards. The rule of thumb used by HHS for determining whether an impact is “significant” is an adverse effect equal to 3 percent or more of total annual revenues.

        This proposed rule, if finalized, would impact the vast majority of Medicare-participating providers and suppliers that submit claims for separately payable Medicare Part B drugs by preventing the impacts described in the November 2020 interim final rule (85 FR 76246) from being realized. There are over 20,000 small entities that would be included or affected by the MFN Model if the model was implemented. We refer readers to Table 3 and Table 8 in the November 2020 interim final rule (85 FR 76195 and 76219, respectively) to see the number of entities, as well as the types of providers and suppliers, that would be most likely impacted by the MFN Model. This proposed rule proposes to withdraw the MFN Model, and therefore would likely impact these same entities. Accordingly, we have determined that a Regulatory Flexibility Analysis (RFA) is required. As its measure of significant economic impact on a substantial number of small entities, HHS uses a change in revenue of more than 3 to 5 percent. We do believe that this threshold will be reached by the requirements in this proposed rule. Therefore, the Secretary has certified that this proposed will have a significant economic impact on a substantial number of small entities. The RFA presented in the November 2020 interim final rule (85 FR 76245) describes the potential impact of the MFN Model, if it was implemented, on small entities. If finalized, this proposed rule would prevent those impacts from being realized. Specifically, the lower drug payments and alternative add-on payments described in section III.F. of the November 2020 interim final rule would not occur. Instead, payment for submitted claims would be made under the applicable Medicare payment methodology. This RFA, together with the preamble, constitutes the required analysis.
        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 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. Similar to urban entities, we estimate that this proposed rule, if finalized, would have a significant impact on small rural hospitals by preventing the impacts described in the November 2020 interim final rule (85 FR 76246) from being realized. Specifically, if the MFN Model was implemented, these rural entities would experience drug payment reductions and overall payment reductions similar to urban entities. Instead, if this proposed rule is finalized, payment for submitted claims would be made under the applicable Medicare payment methodology.
        We welcome comments on our estimate of significantly affected providers and suppliers and the magnitude of estimated effects for this proposed rule.
        E. Unfunded Mandates Reform Act (UMRA)
        Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2021, that threshold is approximately $158 million. As discussed in section V.C. of this proposed rule, the financial impacts for States (that is, an estimated overall reduction in State spending) presented in the November 2020 interim final rule (85 FR 76235 through 76248) would not be realized. This proposed rule does not mandate any spending by State, local, or tribal governments, or by the private sector, and hence an UMRA analysis is not required.
        F. Federalism
        Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. As discussed in section V.C. of this proposed rule, the financial impacts for States (that is, an estimated overall reduction in State spending) presented in the November 2020 interim final rule (85 FR 76235 through 76248) would not be realized. Since this regulation does not impose any costs on State or local governments, preempt State law, or otherwise have Federalism implications, the requirements of Executive Order 13132 are not applicable.
        In accordance with the provisions of Executive Order 12866, this proposed rule was reviewed by the Office of Management and Budget.
        Chiquita Brooks-LaSure, Administrator of the Centers for Medicare & Medicaid Services, approved this document on July 21, 2021.

          List of Subjects for 42 CFR 513
          Administrative practice and procedure, Health facilities, Medicare, Reporting and recordkeeping requirements.

          PART 513—[REMOVED]

        For the reasons set forth in the preamble and under the authority at 5 U.S.C. 301, the Centers for Medicare & Medicaid Services proposes to remove 42 CFR part 513.

          Dated: August 3, 2021.
          Xavier Becerra,
          Secretary, Department of Health and Human Services.

      [FR Doc. 2021-16886 Filed 8-6-21; 4:15 pm]
      BILLING CODE 4120-01-P


        DEPARTMENT OF COMMERCE
        National Oceanic and Atmospheric Administration
        50 CFR Part 660
        RIN 0648-BA01
        Fisheries Off West Coast States; Notice of Availability for Amendments 16-5 and 23 to the Pacific Coast Groundfish Fishery Management Plan

          AGENCY:
           National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

          ACTION:
           Availability of amendments to a fishery management plan; request for comments.

          SUMMARY:
           NMFS announces that the Pacific Fishery Management Council (Council) has submitted Amendments 16-5 and 23 to the Pacific Coast Groundfish Fishery Management Plan (FMP) for Secretarial review. Amendment 16-5 would modify the FMP to implement an overfished species rebuilding plan for petrale sole and revise existing overfished species rebuilding plans. In addition, Amendment 16-5 would modify the default proxy values for FMSY and BMSY as they apply to the flatfish species, including petrale sole; and the harvest control rule policies. Amendment 23 introduces a new framework for fishery specifications and other measures for establishing Annual Catch Limits (ACLs) as required by the recent amendments to the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).

          DATES:
           Comments on Amendments 16-5 and 23 must be received on or before November 30, 2010.

          ADDRESSES:
           You may submit comments, identified by RIN 0648-BA01, by any of the following methods:

          • Electronic Submissions: Submit all electronic public comments via the Federal e-Rulemaking Portal, at http://www.regulations.gov.
          • Fax: 206-526-6736; Attn: Becky Renko.
          • Mail: William Stelle, Regional Administrator, Northwest Region, NMFS, 7600 Sand Point Way NE., Seattle, WA 98115-0070; Attn: Becky Renko

          Instructions: All comments received are a part of the public record and will generally be posted to http://www.regulations.gov without change. All Personal Identifying Information (for example, name, address, etc.) voluntarily submitted by the commenter may be publicly accessible. Do not submit Confidential Business Information or otherwise sensitive or protected information. NMFS will accept anonymous comments (if submitting comments via the Federal e-Rulemaking portal, enter “N/A” in the relevant required fields if you wish to remain anonymous). Attachments to electronic comments will be accepted in Microsoft Word or Excel, WordPerfect, or Adobe PDF file formats only.

          FOR FURTHER INFORMATION CONTACT:

           Becky Renko (Northwest Region, NMFS), phone: 206-526-6110; fax: 206 526 6736; and e mail: becky.renko@noaa.gov.

        SUPPLEMENTARY INFORMATION:
        Electronic Access
        This Federal Register document is also accessible via the internet at the website of the Office of the Federal Register: http://www.access.gpo.gov/su-docs/aces/aces140.html.
        The Magnuson-Stevens Act requires that each regional fishery management council submit any FMP or plan amendment it prepares to NMFS for review and approval, disapproval, or partial approval. The Magnuson-Stevens Act also requires that NMFS, upon receiving an FMP or amendment, immediately publish a notice that the FMP or amendment is available for public review and comment. NMFS will consider the public comments received during the comment period described above in determining whether to approve Amendments 16-5 and 23 to the FMP.
        Petrale sole was declared overfished on February 9, 2010. Amendment 16-5 adds a new rebuilding plan for petrale sole to the FMP and revises the seven existing overfished species rebuilding plans consistent with the Magnuson-Stevens Act. The following groundfish species have been declared as overfished and are currently being managed under rebuilding plans: bocaccio in the Monterey and Conception areas; canary rockfish; cowcod south of Point Conception to the U.S. Mexico boundary; darkblotched rockfish, Pacific Ocean Perch (POP), widow rockfish, and yelloweye rockfish.

        In the FMP, MSY refers to a constant harvest rate (F) control rule that is assumed to produce the maximum average yield over time while protecting the spawning potential of the stock. The constant F control rule is generally the proxy for the MSY control rule. The long-term average biomass associated with fishing at FMSY is BMSY. Fishing rates above FMSY eventually result in biomass smaller than BMSY and produce less harvestable fish on a sustainable basis. The Council uses default FMSY proxies for species groups. If sufficient information becomes available to develop more appropriate values of FMSY, BMSY, and harvest control rules for individual species or species groups the FMP allows those more specific values to be used. Amendment 16-5 revises the proxy FMSY value for all flatfish species from F40% to F30%.
        BMSY (or its proxy) is used as a reference point for rebuilding for overfished stocks, such as petrale sole. Amendment 16-5 revises the proxy BMSY value for all flatfish species from B40% to B25%. A rebuilding analysis is used to project the status of the overfished resource into the future under a variety of alternative harvest strategies to determine the probability of recovering to BMSY within a specified time-frame. The overfished threshold is also being revised. The overfished threshold or minimum stock size threshold (MSST) is the estimated biomass level of the stock relative to its unfished biomass (i.e., depletion level), below which the stock is considered overfished. Amendment 16-5 revises the default proxy MSST for the assessed flatfish species from B25% to B12.5%, which is 50 percent of the BMSY target of B25%.

        Amendment 16-5 adds to the FMP a new harvest control rule referred to as the 25-5 harvest control rule for stocks with a BMSY proxy of 25 percent (B25%). When the estimated biomass has fallen below B25% and when the stock is not managed under an overfished species rebuilding plan, the 25-5 harvest control rule would be applied. Under the 25-5 harvest control rule, a precautionary adjustment is made to the ACL when the stock's depletion drops below B25% and at B5%, the ACL is set to zero. The 25-5 harvest control rule is designed to prevent stocks from becoming overfished.
        On January 16, 2009, NMFS adopted revisions to its guidelines implementing Magnuson-Stevens Act National Standard 1 (74 FR 3178) to prevent and end overfishing and rebuild fisheries. In particular, the revised guidelines provide guidance on implementation of the new statutory requirement for annual catch limits (ACLs). The revised guidelines also include new requirements for accountability measures (AMs) and other provisions regarding preventing and ending overfishing and rebuilding fisheries. To comply with the statute and these new guidelines Amendment 23 to the FMP redefines several existing terms and reference points to make them consistent with the new guidelines; provides a framework for the specification of the overfishing limit (OFL), acceptable biological catch (ABC) and ACLs, including control rules for determining the ABC; describes AMs; addresses the formation of stock complexes; and otherwise ensures that the FMP is consistent with the revised guidelines. Further, Amendment 23 removes dusky and dwarf-red rockfish from the FMP because these stocks are not considered to be in the fishery as there are no historical records of them being landed.
        NMFS welcomes comments on the proposed FMP amendments through the end of the comment period. A proposed rule to implement Amendments 16-5 and 23 has been submitted for Secretarial review and approval. NMFS expects to publish and request public review and comment on proposed regulations to implement Amendments 16-5 and 23, along with the groundfish specifications and management measures for 2011 and 2012, in the near future. Public comments on the proposed rule must be received by the end of the comment period on the amendment to be considered in the approval/disapproval decision on the amendment. All comments received by the end of the comment period for the amendment, whether specifically directed to the amendment or the proposed rule, will be considered in the approval/disapproval decision.

          Authority:
           16 U.S.C. 1801 et seq.

          Dated: September 24, 2010.
          Carrie Selberg,
          Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.

      [FR Doc. 2010-24697 Filed 9-28-10; 4:15 pm]
      BILLING CODE 3510-22-S