Bipartisan Bill on Clinical Trial Participation

Representatives Raul Ruiz (D-CA) and Larry Bucshon (R-IN) have introduced bipartisan legislation, Clinical Trial Modernization Act, to improve participation in clinical trials by underrepresented populations. The bill would address economic barriers that can prevent participation in clinical trials, and permit HHS to issue grants or enter into contractual arrangements to support education, outreach, and recruitment for clinical trials for diseases that have a disproportionate impact on underrepresented populations. It would address economic barriers by:

• Exempting from the Anti-Kickback statute free digital health technology that enables trial participation;
• Allowing patient cost-sharing by a drug or device manufacturer in a clinical trial when specific criteria are met;
• Excluding remuneration for participation in clinical trials from taxable income.