Rule2023-28775
Action to Delay Effective Date Consistent With Congressionally Enacted Moratorium
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 29, 2023
Issuing agencies
Health and Human Services DepartmentInspector General Office, Health and Human Services Department
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 249 (Friday, December 29, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
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</html>Indexed from Federal Register on December 29, 2023.
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