Clinical Trial Modernization Act
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Progress
Where this bill stands in the legislative process.
- Introduced
- Passed House
- Passed Senate
- To President
- Became Law
Overview
The Clinical Trial Modernization Act aims to increase participation in clinical trials, particularly among underrepresented populations. It establishes a grant program to fund outreach and recruitment efforts, including community partnerships and digital health technologies. The bill also modifies existing laws to allow for payments to clinical trial participants for expenses and to exempt these payments from certain tax regulations, while establishing safeguards to prevent fraud and ensure appropriate oversight.
Key provisions
- Creates a grant program to support clinical trial recruitment and education in underserved communities.
- Exempts remuneration for clinical trial expenses (travel, meals, etc.) and digital health technology provision from anti-kickback laws.
- Exempts up to $2,000 in remuneration received for participating in a clinical trial from income tax.
- Modifies the Social Security Act to allow for payment of patient cost-sharing obligations in clinical trials, subject to specific requirements.
- Includes provisions to ensure equitable access and prevent inappropriate utilization of healthcare services.
- Provides an exclusion from gross income for payments received by clinical trial participants.
- Defines ‘underrepresented population’ for the purpose of the bill.
- Prioritizes grant and contract awards to entities using multiple languages or focusing on traditionally underrepresented communities.
Who is affected
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Sponsors
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