Federal Register / Vol. 86, No. 20 / Tuesday, February 2, 2021 / Rules and Regulations 7815 

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 

AGENCY: Office of Inspector General 

(OIG), Health and Human Services 

(HHS). 

ACTION: Final rule; delay of effective 

date; correction. 

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. 21–95 

(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 (h)(6) 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 2020–25841 (85 FR 

76666), published on November 30, 

2020 is corrected. 

FOR FURTHER INFORMATION CONTACT: 

Aaron Zajic, (202) 619–0335. 

SUPPLEMENTARY INFORMATION: The 

January 20, 2021 memorandum from the 

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 rule’s effective date 

without advance notice and comment 

under 5 U.S.C. 553(b)(B) because of the 

pendency of litigation challenging the 

final rule, and the Department’s 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 

rule’s 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 (h)(6) 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 (h)(5)(vi) and (viii), as well 

as the addition of new paragraphs 

(h)(5)(iii), (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 2020–25841 (85 FR 76666), 

published on November 30, 2020, the 

following corrections are made: 

§ 1001.952 [Corrected] 

■ 1. On page 76730, third column, 

instruction 2 (including a. and b.) is 

corrected to read as follows: 

■ 2. Section 1001.952 is amended by 

adding paragraphs (h)(6) 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 (h)(5)(vi) and (vii) and 

adding paragraph (h)(5)(viii) 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 (h)(5); 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. 2021–02132 Filed 1–29–21; 8:45 am] 

BILLING CODE 4152–01–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 622 

[Docket No. 160426363–7275–02; RTID 

0648–XA837] 

Coastal Migratory Pelagic Resources 

of the Gulf of Mexico and Atlantic 

Region; 2020–2021 Closure of 

Commercial Run-Around Gillnet for 

King Mackerel 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 


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