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Federal Register / Vol. 86, No. 20 / Tuesday, February 2, 2021 / Rules and Regulations DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General 42 CFR Part 1001
RIN 0936AA08

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 Office of Inspector General OIG, Health and Human Services HHS.
ACTION: Final rule; delay of effective date; correction.

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AGENCY:

SUMMARY: In accordance with the memorandum of January 20, 2021, from the Assistant to the President and Chief of Staff, entitled Regulatory Freeze Pending Review, and given the pendency of litigation, Pharmaceutical Care Management Association v. U.S.
Department of Health and Human Services, et al., Civil Action No. 2195
JDB D.D.C., challenging the final rule, this action temporarily delays for 60
days from the date of the memorandum the effective date of certain amendments as promulgated by the final rule titled 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 November 30, 2020, Federal Register.
This document announces that the effective date for the certain provisions of the final rule is delayed until March 22, 2021, the first business day after 60
days from the date of the memorandum.
This document also corrects a technical error in the amendatory instructions.
DATES: As of January 29, 2021, the effective date of the amendments to 42
CFR 1001.952 h6 through 9, cc, and dd published at 85 FR 76666, November 30, 2020, is delayed until March 22, 2021.
This correction is effective as of March 22, 2021. The amendatory instructions in FR 202025841 85 FR
76666, published on November 30, 2020 is corrected.
FOR FURTHER INFORMATION CONTACT:
Aaron Zajic, 202 6190335.
SUPPLEMENTARY INFORMATION: The January 20, 2021 memorandum from the
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15:58 Feb 01, 2021

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Assistant to the President and Chief of Staff, entitled Regulatory Freeze Pending Review, instructed Federal agencies to consider delaying the effective date of rules published in the Federal Register, but which have not yet taken effect, for a period of 60 days from the date of the memorandum to permit review of the rule. This action is consistent with that memorandum insofar as the Department has decided to review the rule at issue, and needs time to determine what additional action, if any, is appropriate.
The Department also has good cause to delay this rules effective date without advance notice and comment under 5 U.S.C. 553bB because of the pendency of litigation challenging the final rule, and the Departments interest in evaluating its position in that litigation. The litigation includes both procedural and substantive challenges to the rule and its effective date. Though the provisions of the rule being delayed by this notice do not fully overlap with the provisions at issue in the pending litigation, the intersections between the rules various provisions and the overall regulatory framework are complex. HHS
intends to evaluate those interactions as part of its regulatory review process, but needs additional time to do so beyond the current effective date of January 29, 2021.
Accordingly, this final rule delays the effective date of certain portions of the safe harbor regulation concerning discounts for prescription pharmaceutical products at 42 CFR
1001.952. The effective date of new paragraphs h6 through 9, cc, and dd of that rule, which would have been January 29, 2021, is now March 22, 2021. The temporary delay in the effective date of this final rule is necessary to give Department officials the opportunity for further review and consideration of the revisions to paragraphs h5vi and viii, as well as the addition of new paragraphs h5iii, 6 through 9, cc, and dd of 42 CFR 1001.952, consistent with the memorandum of January 20, 2021.
Separately, 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 1001.952 into the CFR.
This document also corrects that error.
In FR 202025841 85 FR 76666, published on November 30, 2020, the following corrections are made:

1001.952

AGENCY:

Corrected
1. On page 76730, third column, instruction 2 including a. and b. is corrected to read as follows:

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2. Section 1001.952 is amended by adding paragraphs h6 through 9, cc, and dd to read as follows:

1001.952

Corrected
2. On page 76731, first column, 1001.952 is corrected by removing 5
, and the text of paragraphs vi through viii.

1001.952

Corrected
3. On page 76731, third column, add amendatory instruction 3 to read as follows:
3. Effective January 1, 2022, 1001.952 is amended by revising paragraphs h5vi and vii and adding paragraph h5viii to read as follows:

1001.952

Exceptions.

h
5
vi Services provided in accordance with a personal or management services contract;
vii Other remuneration, in cash or in kind, not explicitly described in this paragraph h5; or viii A reduction in price or other remuneration in connection with the sale or purchase of a prescription pharmaceutical product from a manufacturer to a plan sponsor under Medicare Part D either directly to the plan sponsor under Medicare Part D, or indirectly through a pharmacy benefit manager acting under contract with a plan sponsor under Medicare Part D, unless it is a price reduction or rebate that is required by law.

Norris Cochran, Acting Secretary.
FR Doc. 202102132 Filed 12921; 8:45 am BILLING CODE 415201P

DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration 50 CFR Part 622
Docket No. 160426363727502; RTID
0648XA837

Coastal Migratory Pelagic Resources of the Gulf of Mexico and Atlantic Region; 20202021 Closure of Commercial Run-Around Gillnet for King Mackerel National Marine Fisheries Service NMFS, National Oceanic and Atmospheric Administration NOAA, Commerce.

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