Encouragement of clinical trial participation by underrepresented populations through payment of study participant clinical trial expenses and provision of digital health technologies

(a) In general Section 1128A(i)(6)(F) of the Social Security Act (42 U.S.C. 1320a–7a(i)(6)(F)) is amended by striking under regulations); and inserting the following: “under regulations, including— (i) remuneration offered or transferred to an individual while participating in a clinical trial, as defined in subsection (d) of the first section 2709 of the Public Health Service Act for expenses incurred as part of the trial, other than patient cost-sharing obligations, including without limitation travel, transportation, and meal expenses, so long as such remuneration is made available to all study participants and facilitates inclusion of patients from all relevant demographic and socioeconomic populations and geographies including rural communities; and (ii) the free provision to an individual of digital health technologies where— (I) the use of the digital health technologies is intended to facilitate the participation of underrepresented patient populations; and (II) the digital health technologies are necessary for participation in such trial;. (b) Conforming amendment to the anti-Kickback statute Section 1128B(b)(3) of the Social Security Act (42 U.S.C. 1320a–7b(b)(3)) is amended— (1) by striking and at the end of subparagraph (K); (2) by striking the period at the end of subparagraph (L) and inserting; and; (3) by aligning the left margin of each of subparagraphs (J) and (K) with the left margin of subparagraph (I); and (4) by inserting after subparagraph (L) the following new subparagraphs: (M) any remuneration offered or transferred to an individual while participating in a clinical trial (as defined in subsection (d) of the first section 2709 of the Public Health Service Act) for expenses incurred as part of the trial, other than patient cost-sharing obligations, including without limitation travel, transportation, and meal expenses, so long as such remuneration is made available to all study participants and facilitates inclusion of patients from all relevant demographic and socioeconomic populations and geographies, including rural communities; and (N) the free provision to an individual of digital health technologies where— (i) the use of the digital health technologies is intended to facilitate in any phase of a clinical trial (as so defined) the participation of underrepresented patient populations; and (ii) the digital health technologies are necessary to such participation.. (c) Effective date The amendments made by this section shall apply to remuneration provided on or after the date of enactment of this Act.