[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5647 Introduced in House (IH)]

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118th CONGRESS
  1st Session
                                H. R. 5647

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 21, 2023

   Mr. McCaul (for himself, Mr. Bera, and Mr. Kelly of Pennsylvania) 
 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 diagnosed with a rare 
 pediatric disease 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 ``Childhood Cancer Clinical Trials 
Act''.

SEC. 2. AMENDMENTS RELATING TO COVERAGE IN INDIVIDUAL AND GROUP MARKET 
              AND UNDER MEDICARE PROGRAM FOR QUALIFIED INDIVIDUALS 
              DIAGNOSED WITH A RARE PEDIATRIC DISEASE 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)(2)--
                            (i) in subparagraph (A), by inserting ``and 
                        subsection (c)(2)'' after ``(1)(B)''; and
                            (ii) in subparagraph (B), by inserting 
                        ``and subsection (c)(2)'' after ``(1)(B)'';
                    (B) by amending subsection (c) to read as follows:
    ``(c) Treatment of Non-Participating Providers.--
            ``(1) In general.--Subject to paragraph (2), this section 
        shall not be construed to require a group health plan, or a 
        health insurance issuer offering group or individual health 
        insurance coverage, to provide benefits for routine patient 
        care services provided outside of the plan's (or coverage's) 
        health care provider network unless out-of-network benefits are 
        otherwise provided under the plan (or coverage).
            ``(2) Qualified individuals diagnosed with a rare pediatric 
        disease.--In the case of a qualified individual diagnosed with 
        a rare pediatric disease, with respect to routine patient costs 
        for items and services furnished to such individual in 
        connection with participation in an approved clinical trial by 
        a nonparticipating provider, a group health plan or health 
        insurance issuer offering group or individual health insurance 
        coverage that provides coverage to such individual--
                    ``(A) 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
                    ``(B) 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 
                subparagraph (A)).''; and
                    (C) by adding at the end the following new 
                subsection:
    ``(i) Other Definitions.--
            ``(1) Nonparticipating provider; participating provider; 
        recognized amount.--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) Rare pediatric disease.--The term `rare pediatric 
        disease' has the meaning given such term in section 529(a)(3) 
        of the Federal Food, Drug, and Cosmetic Act.''.
            (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(d)(1)(A) of the Public Health Service Act 
        (42 U.S.C. 300gg-8(d)(1)(A)) 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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