[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8412 Introduced in House (IH)]

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118th CONGRESS
  2d Session
                                H. R. 8412

 To modernize clinical trials and remove barriers for participation in 
                clinical trials, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 15, 2024

 Mr. Ruiz (for himself and Mr. Bucshon) introduced the following bill; 
  which was 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

_______________________________________________________________________

                                 A BILL


 
 To modernize clinical trials and remove barriers for participation in 
                clinical trials, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Clinical Trial Modernization Act''.

SEC. 2. DEFINITION.

    For purposes of this Act, the term ``underrepresented population'' 
has the meaning given such term by the National Institutes of Health 
for purposes of the Toolkit for Patient-Focused Therapy Development (as 
published on April 1, 2024), in addition to such populations recognized 
by the Food and Drug Administration.

SEC. 3. GRANTS TO ENCOURAGE CLINICAL TRIAL ENROLLMENT BY 
              UNDERREPRESENTED POPULATIONS.

    (a) In General.--The Secretary may issue grants to and enter into 
contracts with entities to support community education, outreach, and 
recruitment activities for clinical trials with respect to devices and 
drugs, including vaccines, for diseases or conditions that have a 
disproportionate impact on underrepresented populations. Such 
activities may include--
            (1) working with community clinical trial sites, including 
        community health centers, academic health centers, sites in 
        rural communities, and other facilities;
            (2) training health care personnel, including potential 
        clinical trial investigators, with a focus on significantly 
        increasing the number of underrepresented populations of health 
        care personnel who are clinical trial investigators at the 
        community sites for ongoing clinical trials;
            (3) engaging community stakeholders to encourage 
        participation in clinical trials, especially in 
        underrepresented populations; and
            (4) fostering partnerships with community-based 
        organizations serving underrepresented populations, including 
        employee unions and frontline health care workers.
    (b) Priority for Grant and Contract Awards.--In awarding grants and 
contracts under this section, the Secretary shall prioritize entities 
that--
            (1) develop educational, recruitment, and training 
        materials in multiple languages; or
            (2) undertake clinical trial outreach efforts in 
        communities that are traditionally underrepresented in clinical 
        trials, such as tribal areas.
    (c) Authorization of Appropriations.--There is authorized to be 
appropriated for fiscal years 2024 and 2025 such sums as may be 
necessary to carry out this section.

SEC. 4. 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.

SEC. 5. ENCOURAGEMENT OF CLINICAL TRIAL ACCESSIBILITY THROUGH SUPPORT 
              OF CLINICAL TRIAL COST-SHARING.

    The payment of patient cost-sharing obligations associated with 
participation in a clinical trial (as defined in subsection (d) of the 
first section 2709 of the Public Health Service Act) or for which a 
diversity action plan is required pursuant to sections 505(z) or 
520(g)(9) of the Federal Food, Drug, and Cosmetic Act by drug or device 
manufacturers or their agents for their clinical trial participants 
shall not be considered a violation of section 1128A of the Social 
Security Act (42 U.S.C. 1320a-7a) (commonly known as the ``Civil 
Monetary Penalties Law''), section 1128B of the Social Security Act (42 
U.S.C. 1320a-7b), or sections 3729 through 3733 of title 31, United 
States Code (commonly known as the ``False Claims Act''), provided that 
the following requirements are met:
            (1) The trial and any coverage of items or services 
        provided in the trial is consistent with all applicable 
        coverage rules by any Federal health care programs providing 
        coverage and reimbursement for beneficiaries participating in 
        the trial as study subjects, including but not limited to, any 
        existing trial qualification requirements imposed by the 
        Centers for Medicare & Medicaid Services for Medicare coverage 
        of the trial.
            (2) The proposed arrangement for the payment of patient 
        cost-sharing obligations is a reasonable means of facilitating 
        enrollment of an underrepresented set of subjects or reducing 
        the likelihood of attrition in the trial by removing a 
        potential financial barrier to participation in the trial.
            (3) Any sponsor payments of participating patient cost-
        sharing obligations must be available throughout the entirety 
        of the clinical trial.
            (4) Any sponsor payments of participating patient cost-
        sharing obligations are not contingent on the future use or 
        purchase of any product or service.
            (5) Any sponsor payments of participating patient cost-
        sharing obligations will not be provided in excess of the 
        patient's cost-sharing obligations under relevant Federal 
        health care programs.
            (6) A participating patient receiving cost-sharing 
        assistance from a sponsor will be required to agree not to 
        accept other financial assistance to cover the patient's cost-
        sharing obligations.
            (7) Any sponsor payments of participating patient cost-
        sharing obligations will cease upon the patient's disenrollment 
        from the clinical trial or the conclusion of the clinical 
        trial, whichever is first.
            (8) The proposed arrangement for the payment of patient 
        cost-sharing obligations includes the following elements to 
        protect against improper increased costs or inappropriate 
        utilization of items and services reimbursed in whole or in 
        part under Federal health care programs:
                    (A) The availability of cost-sharing subsidies will 
                not be advertised, but may be disclosed as required or 
                permitted by law in the informed consent forms, 
                protocol, or other documentation associated with the 
                study.
                    (B) Participating Federal health care program 
                beneficiaries must satisfy formal, objective, and 
                predetermined enrollment criteria and execute an 
                informed consent document.
                    (C) The sponsor must enter into a written agreement 
                with investigators that requires the investigators to 
                comply with the written protocol for the study and to 
                be subject to oversight and monitoring by an 
                institutional review board or other similar body 
                providing independent oversight for the trial.
                    (D) Total enrollment for the trial is capped.

SEC. 6. EXCLUSION FROM GROSS INCOME FOR REMUNERATION PROVIDED BY 
              SPONSORS OF APPROVED CLINICAL TRIALS TO PARTICIPANTS.

    (a) In General.--Part III of subchapter B of chapter 1 of the 
Internal Revenue Code of 1986 is amended by inserting before section 
140 the following new section:

``SEC. 139J. REMUNERATION PROVIDED BY SPONSORS OF APPROVED CLINICAL 
              TRIALS TO PARTICIPANTS.

    ``(a) In General.--Gross income shall not include the value of any 
payment received by an individual from participation in an approved 
clinical trial (as defined in subsection (d) of the first section 2709 
of the Public Health Service Act).
    ``(b) Limitation.--The amount excluded from gross income under 
subsection (a) for any taxable year shall not exceed $2,000.''.
    (b) Clerical Amendment.--The table of sections for part III of 
subchapter B of chapter 1 of the Internal Revenue Code of 1986 is 
amended by inserting before the item relating to section 140 the 
following new item:

``Sec. 139J. Remuneration provided by sponsors of approved clinical 
                            trials to participants.''.
    (c) Effective Date.--The amendments made by this section shall 
apply to taxable years beginning after the date of enactment of this 
Act.
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