Sponsors (6)
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Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Introduced May 20, 2025 by Raul Ruiz · Last progress May 20, 2025
Adds new section 139J to Part III of Subchapter B of the Internal Revenue Code to exclude from gross income the value of payments received by individuals for participation in an approved clinical trial (as defined by subsection (d) of section 2709 of the Public Health Service Act), limited to $2,000 per taxable year.
Amends the table of sections for Part III of Subchapter B by inserting a new item for section 139J before the item relating to section 140.
Strikes and replaces section 1128A(i)(6)(F) of the Social Security Act to provide that remuneration offered or transferred to individuals participating in clinical trials for expenses incurred as part of the trial (other than patient cost‑sharing), including travel, transportation, and meal expenses, is covered when made available to all study participants and facilitates inclusion of underrepresented demographic, socioeconomic, and geographic populations (including rural communities); and to allow the free provision of digital health technologies necessary to facilitate participation by underrepresented patient populations.
Amends section 1128B(b)(3) of the Social Security Act by adjusting formatting of existing subparagraphs and inserting new subparagraphs (M) and (N) that exempt remuneration for clinical trial expenses and the free provision of digital health technologies necessary to facilitate participation of underrepresented patient populations.
States that payment of patient cost‑sharing obligations by drug or device manufacturers (or their agents) for clinical trial participants meeting specified requirements shall not be considered a violation of section 1128A of the Social Security Act (42 U.S.C. 1320a–7a).
States that payment of patient cost‑sharing obligations by drug or device manufacturers (or their agents) for clinical trial participants meeting specified requirements shall not be considered a violation of section 1128B of the Social Security Act (42 U.S.C. 1320a–7b).
States that payment of patient cost‑sharing obligations by drug or device manufacturers (or their agents) for clinical trial participants meeting specified requirements shall not be considered a violation of the False Claims Act (31 U.S.C. 3729–3733).
Authorizes federal grants and contracts to boost community outreach, education, and recruitment so more people from underrepresented groups join clinical trials. It permits payments and necessary digital devices for trial participants, allows manufacturers to pay patients’ trial cost‑sharing under conditions, and excludes up to $2,000/year of trial participation payments from taxable income. The bill also adjusts fraud-and-abuse rules so those payments and devices can be provided without automatically triggering certain anti‑kickback and reimbursement penalties, while preserving other fraud and liability protections.