Health and Human Services Department,
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.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Office of Inspector General 42 CFR Part 1001 RIN 0936-AA08 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) …
Citation: 86 FR 7815
