LUGPA Policy Brief: H.R. 3521 – Clinical Trial Modernization Act

June 2025

On May 20, 2025, Representatives Raul Ruiz (D-CA) and August Pfluger (R-TX) introduced H.R. 3521, the Clinical Trial Modernization Act, a bipartisan proposal aimed at expanding access to clinical trials, especially for communities historically underrepresented in medical research.

The legislation addresses several barriers to trial participation and seeks to:

• Reduce financial and logistical obstacles for patients
• Increase patient diversity across trials
• Promote equitable access to new therapies and innovations

To achieve these goals, the bill proposes targeted reforms to the Social Security Act and the Internal Revenue Code.

Key Provisions

Grants for Community Outreach

The bill authorizes federal grants to support clinical trial education, outreach, and recruitment, prioritizing efforts in underserved and underrepresented areas, including rural and tribal communities.

Eligible uses for grant funding include:

• Training healthcare providers
• Collaborating with community-based organizations
• Creating culturally and linguistically appropriate materials

Coverage of Trial-Related Expenses

H.R. 3521 would allow Medicare to reimburse non-medical costs that often pose barriers to participation, such as:

• Travel and lodging
• Meals
• Digital tools for remote monitoring or communication

These supports must be offered equitably to all trial participants, ensuring fairness across sites.

Patient Cost-Sharing Support

The bill establishes a framework allowing manufacturers of drugs, biologics, or devices to cover participants' cost-sharing responsibilities without violating anti-kickback or civil monetary penalty laws, provided appropriate safeguards are in place to prevent abuse.

Tax Relief for Participants
The legislation excludes up to $2,000 per year of clinical trial compensation from a participant’s taxable income. This provision is designed to reduce financial disincentives, particularly for lower-income individuals who may otherwise decline to participate due to tax implications.

Preservation of Legal Protections
H.R. 3521 clarifies that none of its provisions limit or alter existing legal protections for clinical trial participants.

Implications for LUGPA Members

H.R. 3521 could benefit urology practices engaged in clinical research by making it easier to recruit and support a broader range of participants. The bill:

• Lowers common barriers to participation, improving recruitment and retention
• Clarifies rules for supporting patients financially, reducing compliance risk
• Enables partnerships with community organizations through new outreach grants

These reforms may help independent practices engage more fully in the clinical research ecosystem and expand patient access to innovative treatments for urologic conditions.