[Federal Register Volume 88, Number 249 (Friday, December 29, 2023)]
[Rules and Regulations]
[Pages 90125-90126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-28775]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of Inspector General

42 CFR Part 1001

RIN 0936-AA14


Action to Delay Effective Date Consistent With Congressionally 
Enacted Moratorium

AGENCY: Office of Inspector General (OIG), Department of Health and 
Human Services (HHS).

ACTION: Final rule.

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SUMMARY: This action stays certain amendments to the safe harbors to 
the Federal anti-kickback statute that were promulgated in a final rule 
(``Fraud And Abuse; Removal of Safe Harbor Protection for Rebates 
Involving Prescription Pharmaceuticals and Creation of New Safe Harbor 
Protection for Certain Point-of-Sale Reductions in Price on 
Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager 
Service Fees'') published in the Federal Register on November 30, 2020 
(the 2020 Final Rule). In response to a moratorium enacted by Congress 
on implementation of the 2020 Final Rule, most recently in section 
11301 of the Inflation Reduction Act of 2022, which extended previous 
moratoria on implementation, administration, or enforcement of the 2020 
Final Rule until January 1, 2032, the new effective date for the 
amendments set forth in the 2020 Final Rule is January 1, 2032.

DATES: As of December 29, 2023, 42 CFR 1001.952(h)(5)(viii), 42 CFR 
1001.952(h)(6) through (9), 42 CFR 1001.952(cc), and 42 CFR 
1001.952(dd) are stayed until January 1, 2032.

FOR FURTHER INFORMATION CONTACT: Aaron Zajic, (202) 619-0335.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register published on November 30, 2020, the 
Department issued the 2020 Final Rule establishing four changes to the 
regulatory safe harbors to the Federal anti-kickback statute (section 
1128B(b) of the Social Security Act).\1\ Specifically, the 2020 Final 
Rule: (i) amended 42 CFR 1001.952(h)(5) to remove safe harbor 
protection for reductions in price for prescription pharmaceutical 
products provided to plan sponsors under Part D by making punctuation 
changes to subparagraphs (5)(vi) and (vii) and adding new subparagraph 
paragraph (h)(5)(viii), (ii) added new paragraphs (6)-(9) to 42 CFR 
1001.952(h), (iii) created a new safe harbor at 42 CFR 1001.952(cc) for 
certain point-of-sale reductions in price offered by manufacturers on 
prescription pharmaceutical products that are payable under Medicare 
Part D or by Medicaid managed care organizations that meet certain 
criteria, and (iv) created a new safe harbor at 42 CFR 1001.952(dd) for 
fixed fees that manufacturers pay to pharmacy benefit managers for 
services rendered to the manufacturers that meet specified criteria. 
The 2020 Final Rule was published with an effective date of January 29, 
2021, except for the amendments to 42 CFR 1001.952(h)(5), which were to 
be effective on January 1, 2022.
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    \1\ 85 FR 76666 (Nov. 30, 2020).
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    On January 12, 2021, a lawsuit challenging the final rule was filed 
in the U.S. District Court for the District of Columbia.\2\ Because of 
orders in this lawsuit and in response to a Government memorandum 
regarding postponing effective dates of rules that had not yet taken 
effect, the effective dates of various sections of these amendments to 
the safe harbors were extended multiple times between January and March 
of 2021, and, ultimately, the effective date of the regulatory 
revisions established by the

[[Page 90126]]

2020 Final Rule was extended to January 1, 2023.\3\
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    \2\ Pharmaceutical Care Management Association v. United States 
Department of Health & Human Services et al., No. 1:21-cv-00095 (D. 
DC. filed Jan. 12, 2021).
    \3\ See Pharmaceutical Care Management Association v. United 
States Department of Health & Human Services et al., No. 1:21-cv-
00095 (D. D.C. Jan. 30, 2021) (order granting joint stipulation and 
postponing effective date), Doc. No. 19; see also 86 FR 7815 (Feb. 
2, 2021), 86 FR 10181 (Feb. 19, 2021), and 86 FR 15132 (Mar. 22, 
2021).
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    Subsequently, Congress extended this effective date three times: 
(i) section 90006 of the Infrastructure Investment and Jobs Act, Public 
Law 117-58, prohibited implementation, administration, or enforcement 
of the regulatory revisions established by the 2020 Final Rule prior to 
January 1, 2026; (ii) section 13101 of the Bipartisan Safe Communities 
Act, Public Law 117-159, extended the moratorium on implementation, 
administration, or enforcement until January 1, 2027; and (iii) section 
11301 of the Inflation Reduction Act of 2022, Public Law 117-169, 
further extended the moratorium on implementation, administration, or 
enforcement of the 2020 Final Rule until January 1, 2032.

II. Final Rule

    This final rule stays the amendments made to the safe harbor 
regulations through the 2020 Final Rule, specifically the new 
paragraphs added at 42 CFR 1001.952(h)(5)(viii), 42 CFR 1001.952(h)(6)-
(9), 42 CFR 1001.952(cc), and 42 CFR 1001.952(dd). Pursuant to the most 
recent congressional mandate in section 11301 of the Inflation 
Reduction Act of 2022, Public Law 117-169, the 2020 Final Rule's 
revisions to the safe harbor regulations will be stayed until January 
1, 2032.

III. Regulatory Impact Statement

    As set forth below, we have examined the impact of this final rule 
as required by the Administrative Procedure Act, Executive Order 12866, 
the Regulatory Flexibility Act of 1980, the Unfunded Mandates Reform 
Act of 1995, and Executive Order 13132.

A. Administrative Procedure Act

    To the extent that 5 U.S.C. 553 applies to this action, 
implementation of this action without opportunity for public comment is 
based on the good cause exception in 5 U.S.C. 553(b)(B). Seeking public 
comment is impracticable, unnecessary, and contrary to the public 
interest. The postponement of the effective date, until January 1, 
2032, is required by law. Seeking prior public comment on this 
postponement would have been impracticable, as well as contrary to the 
public interest in the orderly issue and implementation of regulations.

B. Executive Order 12866 and the Regulatory Flexibility Act

    Because no notice of proposed rulemaking is required for this rule, 
the provisions of the Regulatory Flexibility Act do not apply. 
Furthermore, this document does not meet the criteria for a significant 
regulatory action as specified in Executive Order 12866.

C. Unfunded Mandates Reform Act

    Section 202 of the Unfunded Mandates Reform Act of 1995, Public Law 
104-4, requires that agencies assess anticipated costs and benefits 
before issuing any rule that may result in expenditures in any one year 
by State, local, or Tribal Governments in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation). We believe that this final rule will not impose any 
mandates on State, local, or Tribal Governments or the private sector 
that would result in an expenditure of $100 million or more (adjusted 
for inflation) in any given year, and that a full analysis under the 
Unfunded Mandates Reform Act is not necessary.

D. Executive Order 13132

    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a rule that imposes substantial 
direct requirements or costs on State and local governments, preempts 
State law, or otherwise has federalism implications. In reviewing this 
final rule under the threshold criteria of Executive Order 13132, 
Federalism, we have determined that this final rule would not 
significantly limit the rights, roles, and responsibilities of State or 
local governments. We have determined, therefore, that a full analysis 
under Executive Order 13132 is not necessary.

IV. Paperwork Reduction Act

    In accordance with section 3506(c)(2)(A) of the Paperwork Reduction 
Act of 1995, we are required to solicit public comments, and receive 
final approval from the Office of Management and Budget, on any 
information collection requirements set forth in rulemaking. This final 
rule will not impose any information collection burden or affect 
information currently collected by OIG.

List of Subjects in 42 CFR Part 1001

    Administrative practice and procedure, Fraud, Grant programs--
health, Health facilities, Health professions, Maternal and child 
health, Medicaid, Medicare, Social Security.

    For the reasons set forth above, the following provisions of 42 CFR 
part 1001 are stayed as set forth below:

PART 1001--PROGRAM INTEGRITY--MEDICARE AND STATE HEALTH CARE 
PROGRAMS

0
1. The authority citation for part 1001 continues to read as follows:

    Authority: 42 U.S.C. 1302; 1320a-7; 1320a-7b; 1395u(j); 
1395u(k); 1395w-104(e)(6), 1395y(d); 1395y(e); 1395cc(b)(2)(D), (E), 
and (F); 1395hh; 1842(j)(1)(D)(iv), 1842(k)(1), and sec. 2455, Pub. 
L. 103-355, 108 Stat. 3327 (31 U.S.C. 6101 note).

    2. In Sec.  1001.952, paragraphs (h)(5)(viii), (h)(6) through (9), 
(cc), and (dd) are stayed until January 1, 2032.

    Dated: December 26, 2023.
Xavier Becerra,
Secretary.
[FR Doc. 2023-28775 Filed 12-28-23; 8:45 am]
BILLING CODE 4152-01-P