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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. |
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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 |
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Timetable:
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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 |