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HHS/OIG RIN: 0936-AA08 Publication ID: Spring 2019 
Title: Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection 

The Final Rule would revise the discount safe harbor related to rebates to plans or pharmacy benefit managers involving pharmaceuticals. In addition, this Final Rule proposes 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: Final Rule Stage 
Major: Yes  Unfunded Mandates: No 
EO 13771 Designation: Regulatory 
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
Action Date FR Cite
Final Action  11/00/2019 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Undetermined 
Small Entities Affected: No  Federalism: No 
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