Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Federal Anti-Kickback Statute and Beneficiary Inducements CMP
Published Date: 1/29/2026
Proposed Rule
Summary
The government wants your thoughts on updating rules that stop sneaky deals and freebies in Medicare and state health programs, especially for new drug sales like those on TrumpRx. This could change how drug companies sell directly to patients, making meds fairer and cheaper for Americans. Speak up by March 30, 2026, to help shape these important changes that could save money and protect patients.
Analyzed Economic Effects
4 provisions identified: 3 benefits, 0 costs, 1 mixed.
TrumpRx: Direct-to-Consumer Drug Platform
HHS is establishing TrumpRx, a platform to let American patients buy prescription drugs directly from manufacturers at a “Most‑Favored‑Nation” price, bypassing middlemen. HHS says removing government obstacles to ensure access to affordable prescription drugs through TrumpRx is a key priority and is seeking public input through this request for information.
Potential Changes to Anti‑Kickback Safe Harbors
The OIG is asking whether to modify or add safe harbors to the Federal anti‑kickback statute (42 CFR 1001.952) and exceptions to the Beneficiary Inducements CMP (42 CFR 1003.110) to support direct‑to‑consumer manufacturer drug sales while protecting against fraud and abuse. The agency requests public comment by March 30, 2026.
Safe Harbor for Personal Services/Management Contracts
The RFI notes that existing safe harbors relevant to direct‑to‑consumer programs may include the personal services and management contracts safe harbor (42 CFR 1001.952(d)) and asks for input on conditions that should be included in any new or modified safe harbor.
Guidance vs Regulation for DTC Sales
OIG is asking whether clarifying guidance (for example, an amended Special Advisory Bulletin, FAQs, or other guidance) might be sufficient instead of new regulations to address direct‑to‑consumer sales to people covered by Federal health care programs. The RFI seeks examples and feedback and sets a comment deadline of March 30, 2026.
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Key Dates
Department and Agencies
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