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Federal Register / Vol. 86, No. 247 / Wednesday, December 29, 2021 / Rules and Regulations is directly linked to the clinical value they provide patients.3
Comment: Some commenters offered views on potential policies and alternative payment models that HHS
and CMS could consider.
Response: We thank stakeholders for their comments. These topics are outside the scope of this rule, but we may consider the comments in the future.
Final Decision: After considering the comments on our proposal, we are finalizing our proposal as proposed. In this final rule, we rescind the November 2020 MFN Model interim final rule and remove the associated regulatory text at 42 CFR part 513. Thus, as a result of this final rule, the MFN Model is withdrawn, effective on the date specified in the DATES section of this final rule.
III. Collection of Information Requirements As stated in section 1115Ad3 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 MFN
Model interim final rule 85 FR 76221, 76222, and 76244, respectively. We are finalizing the provisions of the August 2021 proposed rule, which proposed to rescind requirements related to the information collection described in the November 2020 MFN Model interim final rule. As such, the estimate of the impact of this final rule in section IV.C.
of this final rule includes the savings from rescinding the information collection requirements in the November 2020 MFN Model interim final rule. Further, the August 2021
proposed rule and this final rule do 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..

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3 https aspe.hhs.gov/sites/default/files/2021-09/
Drug_Pricing_Plan_9-9-2021.pdf.

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We did not receive comments on the discussion of information collection in the proposed rule.
IV. Regulatory Impact Analysis A. Statement of Need The purpose of this final rule is to finalize the rescission of the Most Favored Nation Model 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 these actions will 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 1102b of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 March 22, 1995; Pub. L.
1044, Executive Order 13132 on Federalism August 4, 1999, and the Congressional Review Act 5 U.S.C.
8042.
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 3f 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
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policy issues arising out of legal mandates, the Presidents priorities, or the principles set forth in the Executive Order.
Based on our estimates, OMBs Office of Information and Regulatory Affairs has determined this rulemaking is economically significant as measured by the $100 million threshold, and hence also a major rule under Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 also known as the Congressional Review Act. Accordingly, we have prepared a regulatory impact analysis 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 withdraws the MFN Model, prevents realization of the annualized/monetized estimates of costs and transfers presented in the November 2020 MFN Model interim final rule 85
FR 76235 through 76248. The RIA of the November 2020 MFN Model 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 a financial hardship exemption.
In the November 2020 MFN Model 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 MFN Model 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
MFN Model interim final rule, such effects have not occurred.

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