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HHS/OIG RIN: 0936-AA08 Publication ID: Spring 2021 
Title: Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection 
Abstract:

The Final Rule  revises the discount safe harbor to remove from the definition of discount” reductions in price or other remuneration from a manufacturer of prescription pharmaceutical products to plan sponsors under Part D or pharmacy benefit managers under contract with them. In addition, this Final Rule would create two new safe harbors.

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: Yes  Unfunded Mandates: State, local, or tribal governments 
CFR Citation: 42 CFR 1001.952(h) (to be modified)    42 CFR 1001.952(cc) (to be added)    42 CFR 1001.952(dd) (to be added)   
Legal Authority: sec. 1128D of the Social Security Act   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Final Rule  11/30/2020  85 FR 76666   
Final Rule Effective except for the amendments to 42 CFR 1001.952(h)(5)  01/29/2021 
Final Rule Effective for the amendments to 42 CFR 1001.952(h)(5)  01/01/2022 
Final Rule; Delay of Effective Date; Correction  02/02/2021  86 FR 7815   
Final Rule; Notification of Court-Ordered Delay of Effective Date  02/19/2021  86 FR 10181   
Final Rule; Notification of Court-Ordered Delay of Effective Date  03/22/2021  86 FR 15132   
Final Rule Effective  01/01/2023 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Local, State 
Small Entities Affected: No  Federalism: Yes 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Aaron Zajic
Department of Health and Human Services
Office of the Inspector General
Washington, DC 20201
Phone:202 619-0335