Office of Inspector General December 29, 2023 – Federal Register Recent Federal Regulation Documents
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Action to Delay Effective Date Consistent With Congressionally Enacted Moratorium
This action stays 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 in the Federal Register on November 30, 2020 (the 2020 Final Rule). In response to a moratorium enacted by Congress on implementation of the 2020 Final Rule, most recently in section 11301 of the Inflation Reduction Act of 2022, which extended previous moratoria on implementation, administration, or enforcement of the 2020 Final Rule until January 1, 2032, the new effective date for the amendments set forth in the 2020 Final Rule is January 1, 2032.
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