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HHS/OIG RIN: 0936-AA15 Publication ID: 2026 
Title: ●Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Federal Anti-Kickback Statute and Beneficiary Inducements CMP 
Abstract:

This request for information seeks input from the public on whether any additions or modifications are needed to the safe harbor regulations at 42 CFR 1001.952 under the Federal anti-kickback statute or the exceptions to the civil monetary penalty provision prohibiting inducements to beneficiaries (the Beneficiary Inducements CMP”) at 42 CFR 1003.110 for emerging direct-to-consumer (DTC”) sales programs established by pharmaceutical manufacturers, including those that will be available through TrumpRx.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Prerule Stage 
Major: No  Unfunded Mandates: No 
EO 14192 Designation: Other 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: Not Yet Determined   
Legal Deadline:  None
Timetable:
Action Date FR Cite
ANPRM  07/00/2026 
Regulatory Flexibility Analysis Required: Undetermined  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:
Susan Edwards
Department of Health and Human Services
Office of the Inspector General
200 Independence Avenue SW,
Washington, DC 20201
Phone:202 708-9845