Encourages broader participation in drug and medical-device clinical trials by underrepresented groups, including rural, tribal, and lower-income patients. Trial sponsors could pay for participants' travel, transportation, and meal expenses and provide free digital health technologies without violating federal anti-kickback or False Claims Act rules, as long as the payments are open to all participants. Sponsors could also cover patient cost-sharing for trials that have an FDA-required diversity action plan, subject to eight guardrails including capped enrollment and no advertising. The bill also lets participants exclude up to $2,000 per year in trial payments from federal income tax and authorizes federal grants for community trial outreach in fiscal years 2027 and 2028.
Average Household Impact
- Tax exclusion for clinical trial payments — Up to $2,000 per year
- Coverage of trial travel and cost-sharing for participants — Permitted without anti-kickback liability
Corporate Benefits
- Drug and device sponsors — New safe harbors under anti-kickback and False Claims Act
Congressional Summary
Clinical Trial Modernization ActThis bill authorizes a grant program and provides certain exemptions to support the participation of individuals in clinical trials.Specifically, the bill authorizes a grant program to support outreach, education, and recruitment efforts for clinical trials that may benefit certain underrepresented populations or communities in need, such as rural or tribal areas.The bill also exempts from anti-kickback laws for federal health care programs (1) remuneration that is offered to cover participants' expenses to participate in clinical trials, (2) the provision of free digital health technologies to support participation of underrepresented populations in clinical trials, and (3) payment for participants' cost-sharing obligations in relation to clinical trials.Finally, the bill exempts up to $2,000 in remuneration that is received for participating in a clinical trial from income tax.
Details
- Congress
- 119th
- Chamber
- Senate
- Status
- summarized
- Action
- Introduced in Senate
- Action Date
- 2026-04-29
- Date Added
- 2026-05-22
- Source
- Congress.gov →
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