Clinical Trial Modernization Act

This bill seeks to modernize clinical trials and remove barriers to participation, with a particular focus on increasing enrollment from underrepresented populations . It authorizes the Secretary to issue grants and contracts to support community education, outreach, and recruitment activities for clinical trials involving devices and drugs, including vaccines. These activities include working with community health centers, training healthcare personnel, engaging community stakeholders, and fostering partnerships with community-based organizations, prioritizing entities that develop multilingual materials or conduct outreach in traditionally underserved areas like tribal communities. To encourage broader participation, the legislation amends the Social Security Act to allow for remuneration to individuals for expenses incurred during clinical trials, such as travel, transportation, and meals. It also permits the free provision of digital health technologies , provided these are made available to all study participants and facilitate the inclusion of diverse demographic and socioeconomic populations. These amendments clarify that such provisions do not violate anti-kickback statutes when intended to facilitate participation, especially for underrepresented patient populations. The bill further stipulates that the payment of patient cost-sharing obligations by drug or device manufacturers for clinical trial participants will not be considered a violation of anti-kickback or False Claims Act provisions, subject to several strict requirements. These conditions include ensuring consistency with federal healthcare program rules, serving as a reasonable means to facilitate enrollment or reduce attrition, and not being contingent on the future use or purchase of any product. Additionally, the bill establishes an exclusion from gross income for up to $2,000 in remuneration received by individuals participating in approved clinical trials, effective for taxable years beginning after the date of enactment.