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; Additional Delayed Effective Date
other · US Department of Health and Human Services · Rule · Published 2021-03-22 · Effective 2023-01-01 · 86 FR 15132
Document
Document number
2021-05903
Federal Register citation
86 FR 15132
CFR reference
42 CFR 1001
Type
Rule
Action
Final rule; notification of court-ordered delay of effective date.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
2021-03-22
Effective date
2023-01-01
Abstract
As required by an order issued by the U.S. District Court for the District of Columbia, this action provides notice of the delay of the effective date of 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 on November 30, 2020. The new effective date for these certain amendments is January 1, 2023.