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; Additional Delayed Effective Date, 15132-15133 [2021-05903]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• Office of Inspector General

[Federal Register Volume 86, Number 53 (Monday, March 22, 2021)]
[Rules and Regulations]
[Pages 15132-15133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05903]


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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; Additional 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 March 18, 2021, the January 29, 2021 effective date of the 
amendments to 42 CFR 1001.952(h)(6)

[[Page 15133]]

through (9), (cc), and (dd) published at 85 FR 76666, November 30, 
2020, which was delayed to March 22, 2021, pursuant to the rule 
published at 86 FR 7815, February 2, 2021, is further delayed until 
January 1, 2023. In addition, the effective date of the corrections 
published at 86 FR 7815, February 2, 2021, is delayed from March 22, 
2021, to 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 (h)(6) through (9) to 
42 CFR 1001.952, 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.
    On January 12, 2021, a lawsuit challenging the final rule was filed 
in the U.S. District Court for the District of Columbia.\1\ On January 
30, 2021, the Court issued an order postponing until January 1, 2023, 
the effective date of the provisions of the final rule that were 
scheduled to take effect on January 1, 2022.\2\ Consistent with that 
order, the Department notified the public that the effective date of 
the amendments to 42 CFR 1001.952(h)(5) in the final rule is now 
January 1, 2023.\3\
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    \1\ Pharmaceutical Care Management Association v. United States 
Department of Health & Human Services et al., No. 1:21-cv-00095 (D. 
D.C. filed Jan. 12, 2021).
    \2\ 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.
    \3\ 86 FR 10181 (Feb. 19, 2021).
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    In the Federal Register of February 2, 2021, the Department 
announced that it was undertaking a regulatory review of the 
interactions between the final rule's various provisions and the 
overall regulatory framework.\4\ To assure adequate time to determine 
what additional action, if any, would be appropriate, the Department 
delayed until March 22, 2021, 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. In addition, the Department determined that 
the November 2020 final rule contained a technical error in the 
amendatory instructions that would have prevented the Office of the 
Federal Register from properly incorporating the amendments to Sec.  
1001.952 into the CFR. The Department's February 2, 2021, Federal 
Register publication therefore announced a technical correction to 
those instructions that would likewise take effect on March 22, 2021.
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    \4\ 86 FR 7815 (Feb. 2, 2021).
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    On March 15, 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 March 22, 2021.\5\ Consistent 
with that order, the Department is taking this action to notify the 
public that the effective date of the amendments to 42 CFR 
1001.952(h)(6) through (9), (cc), and (dd) in the final rule (inclusive 
of the technical correction) 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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    \5\ Pharmaceutical Care Management Association v. United States 
Department of Health & Human Services et al., No. 1:21-cv-00095 (D. 
D.C .Mar. 15, 2021) (order granting joint stipulation and postponing 
effective date), Doc. No. 27.
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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 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. 2021-05903 Filed 3-18-21; 4:15 pm]
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