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HHS/OIG RIN: 0936-AA08 Publication ID: Fall 2018 
Title: ●Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection 
Abstract:

The NPRM would revise the discount safe harbor related to rebates to plans or pharmacy benefit managers involving pharmaceuticals. In addition, this NPRM proposes a new safe harbor.

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
EO 13771 Designation: Regulatory 
CFR Citation: 42 CFR 1001.952(h) (to be modified)    42 CFR 1001.953(cc) (to be added)   
Legal Authority: sec. 14 of the Medicare and Medicaid Patient and Program Protection Act of 1987   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  10/00/2018 
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