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Clinical Trial Modernization Act

USA119th CongressS-4440| Senate 
| Updated: 4/29/2026
Tim Scott

Tim Scott

Republican Senator

South Carolina

Cosponsors (1)
Mark R. Warner (Democratic)

Finance Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
The Clinical Trial Modernization Act aims to significantly increase participation in clinical trials, particularly among underrepresented populations , by addressing financial and accessibility barriers. It authorizes the Secretary to issue grants and contracts for community education, outreach, and recruitment activities, focusing on diseases disproportionately affecting these populations. These grants prioritize entities that develop multi-language materials and conduct outreach in traditionally underserved communities, such as tribal areas. To encourage participation, the bill amends the Social Security Act and the Anti-Kickback Statute to clarify that certain financial assistance to participants is not considered unlawful. Specifically, it exempts remuneration for clinical trial expenses, such as travel, transportation, and meals, provided it is available to all participants and facilitates inclusion of diverse populations. The free provision of digital health technologies is also exempted if it is intended to facilitate participation by underrepresented patient populations and is necessary for the trial. Furthermore, the legislation allows drug and device manufacturers to cover patient cost-sharing obligations associated with clinical trial participation without violating anti-kickback or false claims laws, provided strict conditions are met. These conditions include ensuring the trial aligns with federal healthcare program coverage rules and that payments are not contingent on future product purchases. Safeguards are also in place, such as not advertising cost-sharing subsidies and capping total trial enrollment, to prevent improper increased costs or inappropriate utilization. Finally, the Act amends the Internal Revenue Code to exclude up to $2,000 of remuneration received by individuals for clinical trial participation from their gross income annually.
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Timeline
May 20, 2025

Latest Companion Bill Action

HR 119-3521
Introduced in House
Apr 29, 2026
Introduced in Senate
Apr 29, 2026
Read twice and referred to the Committee on Finance.
  • May 20, 2025

    Latest Companion Bill Action

    HR 119-3521
    Introduced in House


  • April 29, 2026
    Introduced in Senate


  • April 29, 2026
    Read twice and referred to the Committee on Finance.

Health

Related Bills

  • HR 119-3521: Clinical Trial Modernization Act

Clinical Trial Modernization Act

USA119th CongressS-4440| Senate 
| Updated: 4/29/2026
The Clinical Trial Modernization Act aims to significantly increase participation in clinical trials, particularly among underrepresented populations , by addressing financial and accessibility barriers. It authorizes the Secretary to issue grants and contracts for community education, outreach, and recruitment activities, focusing on diseases disproportionately affecting these populations. These grants prioritize entities that develop multi-language materials and conduct outreach in traditionally underserved communities, such as tribal areas. To encourage participation, the bill amends the Social Security Act and the Anti-Kickback Statute to clarify that certain financial assistance to participants is not considered unlawful. Specifically, it exempts remuneration for clinical trial expenses, such as travel, transportation, and meals, provided it is available to all participants and facilitates inclusion of diverse populations. The free provision of digital health technologies is also exempted if it is intended to facilitate participation by underrepresented patient populations and is necessary for the trial. Furthermore, the legislation allows drug and device manufacturers to cover patient cost-sharing obligations associated with clinical trial participation without violating anti-kickback or false claims laws, provided strict conditions are met. These conditions include ensuring the trial aligns with federal healthcare program coverage rules and that payments are not contingent on future product purchases. Safeguards are also in place, such as not advertising cost-sharing subsidies and capping total trial enrollment, to prevent improper increased costs or inappropriate utilization. Finally, the Act amends the Internal Revenue Code to exclude up to $2,000 of remuneration received by individuals for clinical trial participation from their gross income annually.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
May 20, 2025

Latest Companion Bill Action

HR 119-3521
Introduced in House
Apr 29, 2026
Introduced in Senate
Apr 29, 2026
Read twice and referred to the Committee on Finance.
  • May 20, 2025

    Latest Companion Bill Action

    HR 119-3521
    Introduced in House


  • April 29, 2026
    Introduced in Senate


  • April 29, 2026
    Read twice and referred to the Committee on Finance.
Tim Scott

Tim Scott

Republican Senator

South Carolina

Cosponsors (1)
Mark R. Warner (Democratic)

Finance Committee

Health

Related Bills

  • HR 119-3521: Clinical Trial Modernization Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted