Sec. 2. Amendments relating to coverage in individual and group market and under Medicare program for qualified individuals participating in approved clinical trials
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Section 2709 of the Public Health Service Act ( 42 U.S.C. 300gg–8 ) is amended— in subsection (a)(1)— in subparagraph (B)— by striking subject to subsection (c), ; and by striking and at the end; by redesignating subparagraph
(C)as subparagraph (D); and by inserting after subparagraph
(B)the following new subparagraph: 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— 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 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 ; by striking subsection (c); by redesignating subsections
(d)through
(h)as subsections
(c)through (g), respectively; and by adding at the end the following new subsection: 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). . Section 2709(a)(2)(A) of the Public Health Service Act ( 42 U.S.C. 300gg–8(a)(2)(A) ) is amended— by striking include all items and services and inserting include— all items and services ; and by striking the period at the end and inserting ; and consultation and referral services relating to approved clinical trials furnished to qualified individuals. . 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: The Patient-Centered Outcomes Research Institute. . Section 2709 of the Public Health Service Act ( 42 U.S.C. 300gg–8 ), as amended by the preceding paragraphs, is further amended— in subsection (a)— in paragraph (1)(A), by inserting before clinical trial referred to in subsection (b)(2) the following: approved ; in paragraph (2)(A), by striking a clinical trial and inserting an approved clinical trial ; in paragraph (3)— by striking and inserting in-network providers ; and participating providers by striking a clinical trial and inserting an approved clinical trial ; and in paragraph (4), by striking and inserting out-of-network ; nonparticipating providers in subsection (b)(2)(A), by striking participating health care provider and inserting participating provider ; and in subsection (d)(1)(A)(v), by striking cooperative group and inserting A cooperative group . The amendments made by this subsection shall apply with respect to plan years beginning on or after January 1, 2024. Section 1862(m) of the Social Security Act ( 42 U.S.C. 1395y(m) ) is amended— in paragraph (1), by inserting before as defined by the Secretary the following: subject to paragraph (3), ; and by adding at the end the following new paragraph: 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. . 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) . The amendments made by this subsection shall apply with respect to items and services furnished on or after January 1, 2024.
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- 42 USC 300gg–8
- 42 USC 300gg–8(a)(2)(A)
- 42 USC 300gg–8(c)(1)(A)
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Sec. 2
Amendments relating to coverage in individual and group market and under Medicare program for qualified individuals participating in approved clinical trials
Cite42 USC 300gg–8
Cite42 USC 300gg–8(a)(2)(A)
Cite42 USC 300gg–8(c)(1)(A)
Cites 4Cited by 0 across 0 sources