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
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Section 2709 of the Public Health Service Act ( 42 U.S.C. 300gg–8 ) is amended— in subsection (a)(2)— in subparagraph (A), by inserting and subsection (c)(2) after (1)(B) ; and in subparagraph (B), by inserting and subsection (c)(2) after (1)(B) ; by amending subsection
(c)to read as follows: 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). 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— 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 subparagraph (A)). ; 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). The term rare pediatric disease has the meaning given such term in section 529(a)(3) of the Federal Food, Drug, and Cosmetic Act. . 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(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: 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(d)(1)(A)
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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
Cite42 USC 300gg–8
Cite42 USC 300gg–8(a)(2)(A)
Cite42 USC 300gg–8(d)(1)(A)
Cites 4Cited by 0 across 0 sources