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Federal Register / Vol. 86, No. 151 / Tuesday, August 10, 2021 / Proposed Rules 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 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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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.

policy issues arising out of legal mandates, the Presidents 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, OMBs 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
TABLE 1ACCOUNTING STATEMENT: ESTIMATED IMPACTS FROM CY 2021 TO CY 2028 AS A RESULT OF PROVISIONS OF
THIS PROPOSED RULE BASED ON THE OACT ESTIMATE
Units Category
Estimates
jbell on DSKJLSW7X2PROD with PROPOSALS

Year dollar Costs:
Annualized Monetized $million/year
To Whom

29.4
27.1

Discount rate %

Period covered
2018
2018

7
3

January 2021December 2028.
January 2021December 2028.

2018
2018

7
3

January 2021December 2027.
January 2021December 2027.

Hospital/physicians.

Annualized Monetized $million/year

0.4
0.4

Transfers:

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