Title: Inclusive Clinical Trials Act
Policy area: Health

Summary:
Inclusive Clinical Trials Act
This bill provides for Medicaid coverage of routine patient costs that are associated with participation in certain clinical trials; coverage includes items and services that would otherwise be covered under Medicaid absent the patient's participation in the clinical trial, including with respect to trial complications.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9006 Introduced in House (IH)]

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116th CONGRESS
  2d Session
                                H. R. 9006

 To amend title XIX of the Social Security Act to provide for coverage 
 under the Medicaid program under such title of routine patient costs 
associated with participation in certain clinical trials, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           December 17, 2020

    Mr. Garcia of Illinois introduced the following bill; which was 
            referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend title XIX of the Social Security Act to provide for coverage 
 under the Medicaid program under such title of routine patient costs 
associated with participation in certain 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 ``Inclusive Clinical Trials Act''.

SEC. 2. PARTICIPATION BY MEDICAID BENEFICIARIES IN APPROVED CLINICAL 
              TRIALS.

    (a) In General.--Title XIX of the Social Security Act (42 U.S.C. 
1396 et seq.) is amended by adding at the end the following new 
section:

``SEC. 1947. PARTICIPATION IN AN APPROVED CLINICAL TRIAL.

    ``(a) Coverage of Routine Patient Costs Associated With Approved 
Clinical Trials.--
            ``(1) Inclusion.--Subject to paragraph (2), routine patient 
        costs shall include all items and services consistent with the 
        medical assistance provided under the State plan that would 
        otherwise be provided to the individual under such State plan 
        if such individual was not enrolled in an approved clinical 
        trial, including any items or services related to the 
        prevention, detection, and treatment of any medical 
        complications that arise as a result of participation in the 
        approved clinical trial.
            ``(2) Exclusion.--For purposes of paragraph (1), routine 
        patient costs does not include--
                    ``(A) the investigational item, device, or service 
                itself;
                    ``(B) items and services that are provided solely 
                to satisfy data collection and analysis needs and that 
                are not used in the direct clinical management of the 
                patient; or
                    ``(C) a service that is clearly inconsistent with 
                widely accepted and established standards of care for a 
                particular diagnosis.
            ``(3) Information concerning clinical trials.--
                    ``(A) In general.--Subject to subparagraph (B), the 
                Secretary, in consultation with relevant stakeholders, 
                shall develop a single standardized electronic form for 
                use by the individual or the referring health care 
                provider to submit to the State agency administering 
                the State plan in order to verify that the clinical 
                trial meets the conditions established for an approved 
                clinical trial (as defined in subsection (c)).
                    ``(B) Excluded information.--For purposes of 
                subparagraph (A) or any such request by the State 
                agency for information regarding a clinical trial, an 
                individual or referring health care provider shall not 
                be required to submit--
                            ``(i) the clinical protocol document for 
                        the clinical trial; or
                            ``(ii) subject to subparagraph (C), any 
                        additional information other than such 
                        information as is required pursuant to the form 
                        described in subparagraph (A).
                    ``(C) Optional information.--For purposes of 
                subparagraphs (A) and (B)(ii), the form may include a 
                requirement that the referring health care provider 
                attest that the individual is eligible to participate 
                in the clinical trial pursuant to the trial protocol 
                and that individual participation in such trial would 
                be appropriate.
                    ``(D) Review of information.--
                            ``(i) In general.--A State plan under this 
                        title shall establish a process for timely 
                        review by the State agency of the form and 
                        information submitted pursuant to subparagraph 
                        (A) and, not later than 48 hours after receipt 
                        of such form, confirmation that the information 
                        provided in such form satisfies the 
                        requirements established under such 
                        subparagraph, with such process to include 
                        establishment and operation of a 24-hour, toll-
                        free telephone number and email address to 
                        provide for expedited communication.
                            ``(ii) Failure to respond.--If an 
                        individual or the referring health care 
                        provider does not receive a response or request 
                        for additional information from the State 
                        agency following the 48-hour period described 
                        in clause (i), the information provided in the 
                        form may be presumed to satisfy the 
                        requirements established under this paragraph.
    ``(b) Encouragement of Participation in Approved Clinical Trials.--
            ``(1) Reasonably accessible provider.--For purposes of 
        participation in an approved clinical trial by an individual 
        eligible for medical assistance under this title, the State 
        agency administering the State plan shall make reasonable 
        efforts to ensure that the individual is provided with access 
        to a provider who is--
                    ``(A) participating in the approved clinical trial;
                    ``(B) located not more than 25 miles from the 
                residence of the individual (or, if no such provider is 
                available, as close as possible to the residence of the 
                individual); and
                    ``(C) a participating provider under the State plan 
                or has been deemed to be a participating provider under 
                the State plan for purposes of providing medical 
                assistance to the individual during their participation 
                in the approved clinical trial.
            ``(2) Informational materials.--The State agency 
        administering the plan approved under this title shall develop 
        informational materials and programs to encourage participating 
        providers to make appropriate referrals to physicians and other 
        appropriate health care professionals who can provide 
        individuals with access to approved clinical trials.
    ``(c) Definition of Approved Clinical Trial.--The term `approved 
clinical trial' has the same meaning as provided under subsection (d) 
of section 2709 of the Public Health Service Act that relates to 
coverage for individuals participating in approved clinical trials.''.
    (b) Conforming Amendment.--Section 1902(a) of the Social Security 
Act (42 U.S.C. 1396a(a)) is amended--
            (1) by striking ``and'' at the end of paragraph (84);
            (2) by striking the period at the end of paragraph (85) and 
        inserting ``; and''; and
            (3) by inserting after paragraph (85) the following new 
        paragraph:
            ``(86) provide that participation in an approved clinical 
        trial and coverage of routine patient costs associated with 
        such trial for an individual eligible for medical assistance 
        under this title is conducted in accordance with the 
        requirements under section 1947.''.
    (c) Effective Date.--
            (1) In general.--Except as provided in paragraph (2), the 
        amendments made by this section shall apply to calendar 
        quarters beginning on or after October 1, 2020.
            (2) Delay permitted for state plan amendment.--In the case 
        of a State plan for medical assistance under title XIX of the 
        Social Security Act (42 U.S.C. 1396 et seq.) which the 
        Secretary of Health and Human Services determines requires 
        State legislation (other than legislation appropriating funds) 
        in order for the plan to meet the additional requirements 
        imposed by the amendments made by this section, the State plan 
        shall not be regarded as failing to comply with the 
        requirements of such title solely on the basis of its failure 
        to meet these additional requirements before the first day of 
        the first calendar quarter beginning after the close of the 
        first regular session of the State legislature that begins 
        after the date of enactment of this Act. For purposes of the 
        previous sentence, in the case of a State that has a 2-year 
        legislative session, each year of such session shall be deemed 
        to be a separate regular session of the State legislature.
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