Department of Health and Human Services February 2, 2021 – Federal Register Recent Federal Regulation Documents

In accordance with the memorandum of January 20, 2021 from the Assistant to the President and the Chief of Staff, entitled ``Regulatory Review,'' this action temporarily delays for 60 days the effective date of the December 31, 2020 final rule entitled, ``Medicare Program; Secure Electronic Prior Authorization For Medicare Part D'', which published on December 31, 2020.

The Acting Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer COVID-19 vaccines that are covered countermeasures under section VI of this Declaration.

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.