Clinical Trial Coverage Act of 2022

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. 1. Short title This Act may be cited as the Clinical Trial Coverage Act of 2022 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 (A) in subsection (a)(1)— (i) in subparagraph (B)— (I) by striking subject to subsection (c), (II) by striking and (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 recognized amount . (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) (A) by striking include all items and services 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) (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 (A) in subsection (a)— (i) in paragraph (1)(A), by inserting before clinical trial referred to in subsection (b)(2) approved (ii) in paragraph (2)(A), by striking a clinical trial an approved clinical trial (iii) in paragraph (3)— (I) by striking in-network providers participating providers (II) by striking a clinical trial an approved clinical trial (iv) in paragraph (4), by striking out-of-network nonparticipating providers (B) in subsection (b)(2)(A), by striking participating health care provider participating provider (C) in subsection (d)(1)(A)(v), by striking cooperative group 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) (A) in paragraph (1), by inserting before as defined by the Secretary subject to paragraph (3), (B) by adding at the end the following new paragraph: (3) Routine costs of care In defining routine costs of care . (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) means a trial (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. 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 29 U.S.C. 1167(1) (2) Health insurance issuer The term health insurance issuer 42 U.S.C. 300gg–91(b)(1) (3) Participating provider The term participating provider 42 U.S.C. 300gg–111(a)(3)(G)(ii)

Summary: Clinical Trial Coverage Act of 2022 This bill requires health insurance plans (including Medicare) to cover out-of-network routine care for clinical trial participants at the in-network rate when an in-network provider is not available.