[Federal Register Volume 86, Number 32 (Friday, February 19, 2021)]
[Rules and Regulations]
[Page 10181]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03167]



[[Page 10181]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of Inspector General

42 CFR Part 1001

RIN 0936-AA08


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; Delayed Effective Date

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

ACTION: Final rule; notification of court-ordered delay of effective 
date.

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SUMMARY: As required by an order issued by the U.S. District Court for 
the District of Columbia, this action provides notice of the delay of 
the effective date of 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 on November 30, 2020. The new effective date 
for these certain amendments is January 1, 2023.

DATES: As of February 19, 2021, this action delays the published 
effective date of the amendments to 42 CFR 1001.952(h)(5) published 
November 30, 2020, at 85 FR 76666, and corrected at 86 FR 7815, 
February 2, 2021, until January 1, 2023.

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

SUPPLEMENTARY INFORMATION: In the Federal Register of November 30, 
2020, the Department issued a final rule establishing four changes to 
the regulatory safe harbors to the Federal anti-kickback statute 
(Social Security Act Section 1128B(b)). Specifically, the final rule 
(1) 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; (2) created a new safe harbor at Sec.  
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; (3) created a new safe harbor at Sec.  
1001.952(dd) for fixed fees that manufacturers pay to pharmacy benefit 
managers (PBMs) for services rendered to the manufacturers that meet 
specified criteria; and (4) added new paragraphs (6)-(9) to 42 CFR 
1001.952(h), defining certain terms. The 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.\1\
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    \1\ The effective date of the amendments to 42 CFR 1001.952 
(h)(6) through (9), (cc), and (dd) published at 85 FR 76666, 
November 30, 2020, was subsequently delayed until March 22, 2021. 86 
FR 7815 (Feb. 2, 2021).
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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\ On January 
30, 2021, the Court issued an order postponing until January 1, 2023 
the effective date of all provisions of the final rule that were 
scheduled to take effect on January 1, 2022.\3\ Consistent with that 
order, the Department is taking this action to notify the public that 
the effective date of the amendments to paragraph 42 CFR 1001.952 
(h)(5) in the final rule is now January 1, 2023. Pursuant to the court 
order, any obligation to comply with a deadline tied to the effective 
date of these amendments is similarly postponed, and those obligations 
and deadlines are now tied to the postponed effective date.
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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\ Pharmaceutical Care Management Association v. United States 
Department of Health & Human Services et al., No. 1:21-cv-00095 (D. 
DC Jan. 30, 2021)) (order granting joint stipulation and postponing 
effective date), Doc. No. 19.
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    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 one-year postponement of the effective date, until 
January 1, 2023, is required by court order in accordance with the 
court's authority to postpone a rule's effective date pending judicial 
review (5 U.S.C. 705). 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.

Norris Cochran,
Acting Secretary.
[FR Doc. 2021-03167 Filed 2-18-21; 8:45 am]
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