Clinical Trial Modernization Act
Sponsored By: Senator Scott, Tim [R-SC]
Introduced
Summary
This bill would expand clinical trial participation among underrepresented populations by funding community outreach and training, allowing participant payments and free digital tools, and adding limited tax and legal rules to ease participation.
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- Communities and sites: It would authorize appropriations for 2027 and 2028 to fund grants and contracts for community education, multilingual outreach, recruitment, and partnerships with community health centers, rural sites, academic centers, and tribal areas.
- Participants and families: It would let studies remunerate participants for expenses and provide digital health technologies free when needed to join trials. Payments to participants would be excluded from gross income up to $2,000 per taxable year.
- Sponsors and providers: It would amend the Anti-Kickback rules to recognize such remuneration and tech support as permissible under safeguards. It would also create a non-penalizing framework for sponsor payments of patient cost-sharing when those payments meet conditions like consistency with federal coverage rules, ongoing availability, non-contingency on purchases, and protections against misuse.
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Bill Overview
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Tax break for clinical trial pay
If enacted, you would be able to exclude up to $2,000 a year of payments you receive for participating in an approved clinical trial from your gross income. The exclusion would apply only to payments from approved clinical trials. It would take effect for taxable years beginning after the date of enactment.
Legal safe harbors for trial payments
If enacted, the bill would create legal exceptions and a statutory safe harbor so sponsors can pay participant expenses and provide digital health tools for trials without violating the Anti-Kickback Statute, Civil Monetary Penalties Law, or False Claims Act when specific requirements are met. Sponsors could pay patient cost-sharing for Federal health program beneficiaries only if the payments are consistent with Federal coverage rules (including CMS trial rules), reasonably facilitate enrollment of underrepresented subjects or reduce attrition, are available throughout the trial, are not contingent on future product use, do not exceed the patient's cost-sharing, and cease on disenrollment or trial end. The bill would also except payments for travel, transportation, and meals and the free provision of digital health technologies necessary for participation when they are available to all study participants and intended to increase inclusion. The bill would also clarify that these new rules do not narrow other existing liability protections under Social Security or False Claims laws.
Grants for underrepresented outreach
If enacted, the Secretary would award grants and enter contracts in fiscal years 2027 and 2028, funded at "such sums as may be necessary," to support community education, outreach, recruitment, and training to boost clinical trial participation among underrepresented groups. The program would prioritize entities that produce multilingual materials and do outreach in tribal and other traditionally underrepresented communities. The bill would define "underrepresented population" using the NIH toolkit published April 1, 2024 and populations recognized by the FDA.
Sponsors & CoSponsors
Sponsor
Scott, Tim [R-SC]
SC • R
Cosponsors
Sen. Warner, Mark R. [D-VA]
VA • D
Sponsored 4/29/2026
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov