Clinical Trial Modernization Act
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Progress
Where this bill stands in the legislative process.
- Introduced
- Passed Senate
- Passed House
- 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 support outreach and recruitment efforts, and it modifies existing laws to allow for payments to clinical trial participants for expenses and digital health technologies, as well as to exempt up to $2,000 in remuneration from income tax. The bill also addresses patient cost-sharing obligations, ensuring they don't create barriers to participation and are aligned with existing healthcare coverage rules.
Key provisions
- Creates a grant program to fund community outreach and recruitment for clinical trials, focusing on underrepresented populations.
- Modifies the Social Security Act to allow for payments to clinical trial participants for expenses (travel, meals, etc.) and the provision of digital health technologies.
- Exempts up to $2,000 in remuneration received by participants from income tax.
- Provides a framework for covering patient cost-sharing obligations in clinical trials without violating anti-kickback laws.
- Defines ‘underrepresented population’ for the purposes of the bill.
- Requires grant and contract awards to prioritize entities offering materials in multiple languages and focusing on traditionally underrepresented communities.
- Amends the Internal Revenue Code to exclude remuneration received from clinical trial participants from gross income.
- Establishes rules to protect against improper increased costs or inappropriate utilization of items and services reimbursed under federal healthcare programs.
Bill text
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Sponsors
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2 on record
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