Feds Ask if Paying Trial Participants Counts as Kickback
Published Date: 6/24/2026
Proposed Rule
Summary
The government wants your thoughts on whether rules about paying people to join clinical trials need updating. This affects anyone involved in Medicare and state health programs, especially those running or joining clinical trials. Comments are open until August 24, 2026, so speak up if you think changes could help or hurt trial participation or fairness.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 0 costs, 1 mixed.
Possible Safe Harbor Changes for Trial Payments
The HHS Office of Inspector General is asking whether it should modify or add safe harbors at 42 CFR 1001.952 or exceptions at 42 CFR 1003.110 to protect payments (like waiving cost-sharing or other remuneration) given to people who join clinical trials. The request for information runs through August 24, 2026, and could lead OIG to propose regulatory changes affecting Medicare and State health care program beneficiaries and clinical trial sponsors or sites.
Existing Advisory Opinions Cover Cost-Sharing
OIG has published 10 favorable advisory opinions over the last two decades that permit waiver or subsidization of certain Federal health care program cost-sharing obligations for clinical trial participants by entities like manufacturers, trial sites, and non-profits. OIG has not issued advisory opinions or guidance about other payments to participants such as transportation, childcare, or stipends.
Guidance (Not Just Regulation) Is Under Consideration
OIG explicitly asks whether it should publish or amend guidance (for example, a Special Advisory Bulletin or FAQ) instead of or in addition to changing regulations to clarify protections for remuneration to clinical trial participants. Respondents are invited to comment and provide data by August 24, 2026.
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Key Dates
Department and Agencies
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