[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8546 Introduced in House (IH)]

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117th CONGRESS
  2d Session
                                H. R. 8546

 To amend title XXVII of the Public Health Service Act to require out-
of-network coverage for qualified individuals participating in approved 
                clinical trials, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 27, 2022

Ms. Speier (for herself and Mr. McCaul) 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 amend title XXVII of the Public Health Service Act to require out-
of-network coverage for qualified individuals participating in approved 
                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 Coverage Act of 
2022''.

SEC. 2. AMENDMENTS RELATING TO COVERAGE IN INDIVIDUAL AND GROUP MARKET 
              AND UNDER MEDICARE PROGRAM FOR QUALIFIED INDIVIDUALS 
              PARTICIPATING IN APPROVED CLINICAL TRIALS.

    (a) Individual and Group Market.--
            (1) Requiring out-of-network coverage of routine patient 
        costs.--Section 2709 of the Public Health Service Act (42 
        U.S.C. 300gg-8) is amended--
                    (A) in subsection (a)(1)--
                            (i) in subparagraph (B)--
                                    (I) by striking ``subject to 
                                subsection (c),''; and
                                    (II) by striking ``and'' at the 
                                end;
                            (ii) by redesignating subparagraph (C) as 
                        subparagraph (D); and
                            (iii) by inserting after subparagraph (B) 
                        the following new subparagraph:
                    ``(C) in the case of routine patient costs for 
                items or services furnished to the individual in 
                connection with participation in the trial by a 
                nonparticipating provider--
                            ``(i) shall impose the same cost-sharing 
                        requirement (expressed as a copayment amount or 
                        coinsurance rate) that would apply if such item 
                        or service was furnished by a participating 
                        provider; and
                            ``(ii) shall pay to such nonparticipating 
                        provider the amount by which the recognized 
                        amount for such item or service exceeds the 
                        cost-sharing amount for such item or service 
                        (as determined in accordance with clause (i)); 
                        and'';
                    (B) by striking subsection (c);
                    (C) by redesignating subsections (d) through (h) as 
                subsections (c) through (g), respectively; and
                    (D) by adding at the end the following new 
                subsection:
    ``(h) Other Definitions.--For purposes of this section, the terms 
`nonparticipating provider', `participating provider', and `recognized 
amount' have the meaning given such terms in section 2799A-1(a)(3).''.
            (2) Amendment relating to definition of routine patient 
        costs.--Section 2709(a)(2)(A) of the Public Health Service Act 
        (42 U.S.C. 300gg-8(a)(2)(A)) is amended--
                    (A) by striking ``include all items and services'' 
                and inserting ``include--
                            ``(i) all items and services''; and
                    (B) by striking the period at the end and inserting 
                ``; and
                            ``(ii) consultation and referral services 
                        relating to approved clinical trials furnished 
                        to qualified individuals.''.
            (3) Amendment relating to definition of approved clinical 
        trial.--Section 2709(c)(1)(A) of the Public Health Service Act 
        (42 U.S.C. 300gg-8(c)(1)(A)), as redesignated by paragraph (1), 
        is amended by adding at the end the following new clause:
                            ``(viii) The Patient-Centered Outcomes 
                        Research Institute.''.
            (4) Technical and conforming amendments.--Section 2709 of 
        the Public Health Service Act (42 U.S.C. 300gg-8), as amended 
        by the preceding paragraphs, is further amended--
                    (A) in subsection (a)--
                            (i) in paragraph (1)(A), by inserting 
                        before ``clinical trial referred to in 
                        subsection (b)(2)'' the following: 
                        ``approved'';
                            (ii) in paragraph (2)(A), by striking ``a 
                        clinical trial'' and inserting ``an approved 
                        clinical trial'';
                            (iii) in paragraph (3)--
                                    (I) by striking ``in-network 
                                providers'' and inserting 
                                ``participating providers''; and
                                    (II) by striking ``a clinical 
                                trial'' and inserting ``an approved 
                                clinical trial''; and
                            (iv) in paragraph (4), by striking ``out-
                        of-network'' and inserting ``nonparticipating 
                        providers'';
                    (B) in subsection (b)(2)(A), by striking 
                ``participating health care provider'' and inserting 
                ``participating provider''; and
                    (C) in subsection (d)(1)(A)(v), by striking 
                ``cooperative group'' and inserting ``A cooperative 
                group''.
            (5) Effective date.--The amendments made by this subsection 
        shall apply with respect to plan years beginning on or after 
        January 1, 2024.
    (b) Medicare.--
            (1) Amendment relating to definition of routine costs of 
        care.--Section 1862(m) of the Social Security Act (42 U.S.C. 
        1395y(m)) is amended--
                    (A) in paragraph (1), by inserting before ``as 
                defined by the Secretary'' the following: ``subject to 
                paragraph (3),''; and
                    (B) by adding at the end the following new 
                paragraph:
            ``(3) Routine costs of care.--In defining `routine costs of 
        care' for purposes of paragraph (1), the Secretary shall define 
        such term in a manner that provides for coverage of 
        consultation and referral services furnished to an individual 
        in the course of participation in a category A clinical 
        trial.''.
            (2) Amendment relating to definition of category a clinical 
        trial.--Section 1862(m)(2) of the Social Security Act (42 
        U.S.C. 1395y(m)(2)) is amended by inserting after ``means a 
        trial'' the following: ``(including a trial funded by the 
        Patient-Centered Outcomes Research Institute)''.
            (3) Effective date.--The amendments made by this subsection 
        shall apply with respect to items and services furnished on or 
        after January 1, 2024.

SEC. 3. VOLUNTARY NETWORK OF PARTICIPATING PROVIDERS.

    (a) In General.--The Secretary of Health and Human Services may 
issue a request for information from group health plans, and health 
insurance issuers offering group or individual health coverage to 
identify an interest in establishing a voluntary network of 
participating providers administered by a third-party administrator (as 
designated by the Secretary) for purposes of complying with coverage 
requirements for clinical trials under section 2709 of the Public 
Health Service Act (42 U.S.C. 300gg-8).
    (b) Definitions.--In this section:
            (1) Group health plan.--The term ``group health plan'' has 
        the meaning given such term in section 607(1) of the Employee 
        Retirement Income Security Act of 1974 (29 U.S.C. 1167(1)).
            (2) Health insurance issuer.--The term ``health insurance 
        issuer'' has the meaning given such term in section 2791(b)(1) 
        of the Public Health Service Act (42 U.S.C. 300gg-91(b)(1)).
            (3) Participating provider.--The term ``participating 
        provider'' has the meaning given such term in section 2799A-
        1(a)(3)(G)(ii) of the Public Health Service Act (42 U.S.C. 
        300gg-111(a)(3)(G)(ii)).
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