Federal Anti-Kickback Statute Safe Harbors

Current understanding

The Federal Anti-Kickback Statute (AKS) and Beneficiary Inducements Civil Monetary Penalty (CMP) law prohibit remuneration intended to induce referrals or purchases reimbursed by federal health care programs, subject to regulatory safe harbors defined by HHS-OIG. Modifications to these safe harbors change what payments, discounts, or patient inducements providers, manufacturers, and researchers can offer without triggering fraud-and-abuse liability. HHS is currently soliciting public input on whether safe harbors should be updated to better accommodate remuneration provided to clinical trial participants.

Evidence log

• 2026-04-29 — Clinical Trial Modernization Act: Clinical Trial Modernization Act (introduced) would statutorily exempt participant expense reimbursements and digital health tools provided in clinical trials from anti-kickback liability, rather than relying solely on HHS-OIG safe harbor rulemaking. (novelty: 3)
• 2025-05-20 — Clinical Trial Modernization Act: Clinical Trial Modernization Act (introduced) would carve out an anti-kickback exemption for clinical trial participation expenses, complementing HHS’s ongoing solicitation on safe harbor updates for trial participant remuneration. (novelty: 3)

Open questions

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