Title: CLINICAL TREATMENT Act
Policy area: Health

Summary:
Covering Life-saving Investigations Needed in Cancer and Other Life-threatening Conditions through Timely use of Resources for Easy and Affordable Treatment from Medicaid for Enrollees in Need Today Act or the CLINICAL TREATMENT Act
This bill requires state Medicaid programs to cover routine patient costs for items and services that are provided in connection with a qualifying clinical trial regarding serious or other life-threatening conditions.
The bill defines routine patient costs to include items and services that would otherwise be covered under Medicaid absent the patient's participation in the clinical trial; the term includes items and services relating to trial complications, but excludes those items and services that are the subject of the trial or that are provided solely in relation to data analysis and are not otherwise covered.
Additionally, a qualifying clinical trial means, among other things, a clinical trial that is approved or funded by specified entities (e.g., the National Institutes of Health) or is an authorized new drug trial.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 4742 Introduced in Senate (IS)]

<DOC>






116th CONGRESS
  2d Session
                                S. 4742

  To amend title XIX of the Social Security Act to promote access to 
 life-saving therapies for Medicaid enrollees by ensuring coverage of 
 routine patient costs for items and services furnished in connection 
    with participation in qualifying clinical trials, and for other 
                               purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           September 29, 2020

 Mr. Burr (for himself and Mr. Cardin) introduced the following bill; 
     which was read twice and referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL


 
  To amend title XIX of the Social Security Act to promote access to 
 life-saving therapies for Medicaid enrollees by ensuring coverage of 
 routine patient costs for items and services furnished in connection 
    with participation in qualifying 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 ``Covering Life-saving Investigations 
Needed In Cancer And other Life-threatening conditions through Timely 
use of Resources for Easy and Affordable Treatment from Medicaid for 
Enrollees in Need Today Act'' or the ``CLINICAL TREATMENT Act''.

SEC. 2. PROMOTING ACCESS TO LIFE-SAVING THERAPIES FOR MEDICAID 
              ENROLLEES BY ENSURING COVERAGE OF ROUTINE PATIENT COSTS 
              FOR ITEMS AND SERVICES FURNISHED IN CONNECTION WITH 
              PARTICIPATION IN QUALIFYING CLINICAL TRIALS.

    (a) In General.--Section 1905 of the Social Security Act (42 U.S.C. 
1396d) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (29), by striking ``and'' at the 
                end;
                    (B) by redesignating paragraph (30) as paragraph 
                (31); and
                    (C) by inserting after paragraph (29) the following 
                new paragraph:
            ``(30) subject to subsection (gg), routine patient costs 
        for items and services furnished in connection with 
        participation in a qualifying clinical trial (as defined in 
        such subsection); and''; and
            (2) by adding at the end the following new subsection:
    ``(gg)(1) Routine Patient Costs.--For purposes of subsection 
(a)(30), with respect to a State and an individual enrolled under the 
State plan (or a waiver of such plan) who participates in a qualifying 
clinical trial, routine patient costs--
            ``(A) include any item or service provided to the 
        individual under the qualifying clinical trial, including any 
        item or service provided to prevent, diagnose, or treat 
        complications resulting from such participation, to the extent 
        that the provision of such an item or service to the individual 
        outside the course of such participation would otherwise be 
        covered under the State plan or waiver; and
            ``(B) does not include--
                    ``(i) the investigational item or service that is 
                the subject of the qualifying clinical trial; or
                    ``(ii) an item or service that is--
                            ``(I) provided to the individual solely to 
                        satisfy data collection and analysis needs for 
                        the qualifying clinical trial and is not used 
                        in the direct clinical management of the 
                        individual; and
                            ``(II) not otherwise covered under the 
                        State plan or waiver.
    ``(2) Qualifying Clinical Trial Defined.--
            ``(A) In general.--For purposes of this subsection and 
        subsection (a)(30), the term `qualifying clinical trial' means 
        a clinical trial (in any clinical phase of development) that is 
        conducted in relation to the prevention, detection, or 
        treatment of any serious or life-threatening disease or 
        condition and is described in any of the following clauses:
                    ``(i) The study or investigation is approved or 
                funded (which may include funding through in-kind 
                contributions) by one or more of the following:
                            ``(I) The National Institutes of Health.
                            ``(II) The Centers for Disease Control and 
                        Prevention.
                            ``(III) The Agency for Healthcare Research 
                        and Quality.
                            ``(IV) The Centers for Medicare & Medicaid 
                        Services.
                            ``(V) A cooperative group or center of any 
                        of the entities described in subclauses (I) 
                        through (IV) or the Department of Defense or 
                        the Department of Veterans Affairs.
                            ``(VI) A qualified non-governmental 
                        research entity identified in the guidelines 
                        issued by the National Institutes of Health for 
                        center support grants.
                            ``(VII) Any of the following if the 
                        conditions described in subparagraph (B) are 
                        met:
                                    ``(aa) The Department of Veterans 
                                Affairs.
                                    ``(bb) The Department of Defense.
                                    ``(cc) The Department of Energy.
                    ``(ii) The clinical trial is conducted pursuant to 
                an investigational new drug exemption under section 
                505(i) of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 355(i)) or an exemption for a biological product 
                undergoing investigation under section 351(a)(3) of the 
                Public Health Service Act (42 U.S.C. 262(a)(3)).
                    ``(iii) The clinical trial is a drug trial that is 
                exempt from having such an investigational new drug 
                application.
            ``(B) Conditions.--For purposes of subparagraph 
        (A)(i)(VII), the conditions described in this subparagraph, 
        with respect to a clinical trial approved or funded by an 
        entity described in such subparagraph (A)(i)(VII), are that the 
        clinical trial has been reviewed and approved through a system 
        of peer review that the Secretary determines--
                    ``(i) to be comparable to the system of peer review 
                of studies and investigations used by the National 
                Institutes of Health; and
                    ``(ii) assures unbiased review of the highest 
                scientific standards by qualified individuals with no 
                interest in the outcome of the review.
    ``(3) Coverage Determination Requirements.--A determination with 
respect to coverage under subsection (a)(30) for an individual 
participating in a qualifying clinical trial--
            ``(A) shall be expedited and completed within 24 hours;
            ``(B) shall be made without limitation on the geographic 
        location or network affiliation of the health care provider 
        treating such individual or the principal investigator of the 
        qualifying clinical trial;
            ``(C) shall be based on attestation regarding the 
        appropriateness of the qualifying clinical trial by the health 
        care provider and principal investigator described in 
        subparagraph (B), which shall be made using a streamlined, 
        uniform form developed for national use by the Secretary and 
        that includes the option to reference information regarding the 
        qualifying clinical trial that is publicly available on a 
        website maintained by the Secretary, such as clinicaltrials.gov 
        (or a successor website); and
            ``(D) shall not require submission of the protocols of the 
        qualifying clinical trial, or any other documentation that may 
        be proprietary or determined by the Secretary to be burdensome 
        to provide.''.
    (b) Requiring Mandatory Coverage Under State Plan.--Section 
1902(a)(10)(A) of such Act is amended, in the matter preceding clause 
(i), by striking ``and (29)'' and inserting ``(29), and (30)''.
    (c) Inclusion in Benchmark Coverage.--Section 1937(b)(5) of such 
Act is amended by inserting before the period at the end the following: 
``, and beginning January 1, 2020, coverage of routine patient costs 
for items and services furnished in connection with participation in a 
qualifying clinical trial (as defined in section 1905(gg))''.
    (d) Effective Date.--
            (1) In general.--The amendments made by this section shall 
        apply with respect to items and services furnished on or after 
        the date of the enactment of this Act.
            (2) Exception for state legislation.--In the case of a 
        State plan under title XIX of the Social Security Act (42 
        U.S.C. 1396 et seq.) that the Secretary of Health and Human 
        Services determines requires State legislation in order for the 
        respective plan to meet any requirement imposed by amendments 
        made by this section, the respective plan shall not be regarded 
        as failing to comply with the requirements of such title solely 
        on the basis of its failure to meet such an additional 
        requirement 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 the 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 
        the session shall be considered to be a separate regular 
        session of the State legislature.
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