This bill aims to increase participation in clinical trials among underrepresented populations by removing financial and logistical barriers. The legislation authorizes grants to support community outreach, education, and recruitment efforts, particularly through community health centers and rural facilities, with priority given to organizations working in tribal areas and developing multilingual materials. The bill allows drug and device manufacturers to pay clinical trial participants' expenses such as travel, meals, and transportation, as well as provide free digital health technologies needed for trial participation, without violating federal anti-kickback laws. Additionally, manufacturers may cover patient cost-sharing obligations associated with clinical trials under certain conditions, including that payments be available to all participants and not contingent on future product purchases. The legislation also provides a tax exclusion allowing clinical trial participants to exclude up to $2,000 annually in remuneration from their gross income. Funding is authorized as necessary for fiscal years 2024 and 2025, with the tax and anti-kickback provisions taking effect upon enactment.
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