HR5127-119

1. Short title This Act may be cited as the PrEP and PEP are Prevention Act.

2. No-cost coverage of HIV prevention services Section 2713(a) of the Public Health Service Act (42 U.S.C. 300gg–13(a)) is amended— in paragraph (2), by striking ; and and inserting a semicolon; in paragraph (3), by striking the period and inserting a semicolon; in paragraph (4), by striking the period and inserting a semicolon; in paragraph (5), by striking the period and inserting ; and; and by adding at the end the following: any prescription drug approved by the Food and Drug Administration for the prevention of HIV (other than a drug subject to preauthorization requirements consistent with section 2729A), including any such drug approved for use as pre-exposure prophylaxis (commonly referred to as PrEP) or as post-exposure prophylaxis (commonly referred to as PEP), administrative fees for such drugs, laboratory and other diagnostic procedures associated with the use of such drugs, counseling with respect to HIV prevention (including HIV risk assessment, HIV risk reduction, and medication adherence), and clinical follow up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines, without limitation. Subpart II of part A of title XXVII of the Public Health Service Act (42 U.S.C. 300gg–11 et seq.) is amended by adding at the end the following: A group health plan or a health insurance issuer offering group or individual health insurance coverage shall not impose any preauthorization requirements with respect to coverage of the services described in section 2713(a)(6), except that a plan or issuer may impose preauthorization requirements with respect to coverage of a particular drug approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act or section 351(a) of this Act if such plan or issuer provides coverage without any preauthorization requirements for a drug that is therapeutically equivalent. The amendments made by this subsection shall apply beginning with respect to the first plan year beginning after the date of enactment of this section. Section 1861(s)(2) of the Social Security Act (42 U.S.C. 1395x(s)(2)) is amended— in subparagraph (JJ), by inserting and at the end; and by adding at the end the following new subparagraph: HIV prevention services (as defined in subsection (nnn)); Section 1861 of the Social Security Act (42 U.S.C. 1395x) is amended by adding at the end the following new subsection: The term HIV prevention services means— drugs or biologicals approved by the Food and Drug Administration for the prevention of HIV, including any such drug or biological approved for use as pre-exposure prophylaxis (commonly referred to as PrEP) or as post-exposure prophylaxis (commonly referred to as PEP); administrative fees for such drugs and biologicals; laboratory and other diagnostic procedures associated with the use of such drugs and biologicals; counseling with respect to HIV prevention, including HIV risk assessment, HIV risk reduction, and medication adherence; and clinical follow up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines, without limitation. Section 1833(a)(1) of the Social Security Act (42 U.S.C. 1395l(a)(1)) is amended— by striking and (HH) and inserting (HH); and by inserting before the semicolon at the end the following: , and (II) with respect to HIV prevention services (as defined in section 1861(nnn)), the amount paid shall be 100 percent of (i) except as provided in clause (ii), the lesser of the actual charge for the service or the amount determined under the fee schedule that applies to such services under this part, and (ii) in the case of such services that are covered OPD services (as defined in subsection (t)(1)(B)), the amount determined under subsection (t). The first sentence of section 1833(b) of the Social Security Act (42 U.S.C. 1395l(b)) is amended— by striking , and (13) and inserting (13); and by striking 1861(n).. and inserting 1861(n), and (14) such deductible shall not apply with respect to HIV prevention services (as defined in section 1861(nnn)(1)).. The amendments made by this paragraph shall apply to items and services furnished on or after January 1 of the first calendar year beginning after the date of enactment of this section. Section 1860D–2 of the Social Security Act (42 U.S.C. 1395w–102(b)) is amended— in subsection (b)— in paragraph (1)(A), by striking and (9) and inserting , (9), and (10); in paragraph (2)— in subparagraph (A), by striking and (9) and inserting , (9), and (10); in subparagraph (C)(i), in the matter preceding subclause (I), by striking and (9) and inserting (9), and (10); and in subparagraph (D)(i), in the matter preceding subclause (I), by striking and (9) and inserting (9), and (10); in paragraph (3)(A), in the matter preceding clause (i), by striking and (9) and inserting (9), and (10); in paragraph (4)(A)(i), by striking and (9) and inserting , (9), and (10); and by adding at the end the following new paragraph: With respect to a covered part D drug that is for the prevention of HIV— the deductible under paragraph (1) shall not apply; and there shall be no coinsurance or other cost-sharing under this part with respect to such drug. in subsection (c), by adding at the end the following new paragraph: The coverage is provided in accordance with subsection (b)(10). Section 1860D–14(a) of the Social Security Act (42 U.S.C. 1395w–114(a)) is amended— in paragraph (1)(D), in each of clauses (ii) and (iii), by striking paragraph (6) and inserting paragraphs (6) and (7); in paragraph (2)— in subparagraph (B), by striking and (9) and inserting , (9), and (10); in subparagraph (D), by striking paragraph (6) and inserting paragraphs (6) and (7); and in subparagraph (E), by striking paragraph (6) and inserting paragraphs (6) and (7); and by adding at the end the following new paragraph: With respect to a covered part D drug that is for the prevention of HIV— the deductible under section 1860D–2(b)(1) shall not apply; and there shall be no cost-sharing under this section with respect to such drug. The amendments made by this paragraph shall apply beginning with respect to the first plan year beginning after the date of enactment of this section. Section 1905 of the Social Security Act (42 U.S.C. 1396d) is amended— in subsection (a)(4)— by striking ; and (D) and inserting ; (D); by striking ; and (E) and inserting ; (E); by striking ; and (F) and inserting ; (F); and by striking the semicolon at the end and inserting ; and (G) HIV prevention services;; and by adding at the end the following new subsection: For purposes of subsection (a)(4)(G), the term HIV prevention services means prescription drugs approved by the Food and Drug Administration for the prevention of HIV, including any such drug approved for use as pre-exposure prophylaxis (commonly referred to as PrEP) or as post-exposure prophylaxis (commonly referred to as PEP), administrative fees for such drugs, laboratory and other diagnostic procedures associated with the use of such drugs, counseling with respect to HIV prevention (including HIV risk assessment, HIV risk reduction, and medication adherence), and clinical follow up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines, without limitation. Title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) is amended— in section 1916, by inserting HIV prevention services described in section 1905(a)(4)(G), after section 1905(a)(4)(C), each place it appears; and in section 1916A(b)(3)(B), by adding at the end the following new clause: HIV prevention services described in section 1905(a)(4)(G). Section 1937(b)(7) of the Social Security Act (42 U.S.C. 1396u–7(b)(7)) is amended— in the paragraph header, by inserting and HIV prevention services after supplies; and by striking includes for any individual described in section 1905(a)(4)(C), medical assistance for family planning services and supplies in accordance with such section and inserting includes medical assistance for HIV prevention services described in section 1905(a)(4)(G), and includes, for any individual described in section 1905(a)(4)(C), medical assistance for family planning services and supplies in accordance with such section. Section 2103 of the Social Security Act (42 U.S.C. 1397cc), as amended by section 11405(b)(1) of Public Law 117–169, is amended— in subsection (a), by striking and (8) and inserting (8), and (13); and in subsection (c), by adding at the end the following new paragraph: Regardless of the type of coverage elected by a State under subsection (a), the child health assistance provided for a targeted low-income child, and, in the case of a State that elects to provide pregnancy-related assistance pursuant to section 2112, the pregnancy-related assistance provided for a targeted low-income pregnant woman (as such terms are defined for purposes of such section), shall include coverage of HIV prevention services (as defined in section 1905(ll)). Section 2103(e)(2) of the Social Security Act (42 U.S.C. 1397cc(e)(2)) is amended by inserting HIV prevention services described in subsection (c)(13), before or for pregnancy-related assistance. Subject to subparagraph (B), the amendments made by this subsection shall take effect on January 1 of the first calendar year beginning after the date of enactment of this section. In the case of a State plan approved under title XIX or XXI of the Social Security Act which the Secretary of Health and Human Services determines requires State legislation (other than legislation appropriating funds) in order for the plan to meet the additional requirements imposed by this section, the State plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of the failure of the plan to meet such additional requirements before the 1st day of the 1st calendar quarter beginning after the close of the 1st regular session of the State legislature that ends after the 1-year period beginning with the date of the enactment of this section. For purposes of the preceding sentence, in the case of a State that has a 2-year legislative session, each year of the session is deemed to be a separate regular session of the State legislature. Section 8904 of title 5, United States Code, is amended by adding at the end the following: Any health benefits plan offered under this chapter shall include benefits for, and may not impose any cost-sharing requirements for, any prescription drug approved by the Food and Drug Administration for the prevention of HIV, including any such drug approved for use as pre-exposure prophylaxis (commonly referred to as PrEP) or as post-exposure prophylaxis (commonly referred to as PEP), administrative fees for such drugs, laboratory and other diagnostic procedures associated with the use of such drugs, counseling with respect to HIV prevention (including HIV risk assessment, HIV risk reduction, and medication adherence), and clinical follow up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines, without limitation. The amendments made by this subsection shall apply beginning with respect to the first plan year beginning after the date of enactment of this section. (6)any prescription drug approved by the Food and Drug Administration for the prevention of HIV (other than a drug subject to preauthorization requirements consistent with section 2729A), including any such drug approved for use as pre-exposure prophylaxis (commonly referred to as PrEP) or as post-exposure prophylaxis (commonly referred to as PEP), administrative fees for such drugs, laboratory and other diagnostic procedures associated with the use of such drugs, counseling with respect to HIV prevention (including HIV risk assessment, HIV risk reduction, and medication adherence), and clinical follow up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines, without limitation. . 2729A.Prohibition on preauthorization requirements with respect to certain servicesA group health plan or a health insurance issuer offering group or individual health insurance coverage shall not impose any preauthorization requirements with respect to coverage of the services described in section 2713(a)(6), except that a plan or issuer may impose preauthorization requirements with respect to coverage of a particular drug approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act or section 351(a) of this Act if such plan or issuer provides coverage without any preauthorization requirements for a drug that is therapeutically equivalent.. (KK)HIV prevention services (as defined in subsection (nnn));. (nnn)HIV prevention servicesThe term HIV prevention services means— (1)drugs or biologicals approved by the Food and Drug Administration for the prevention of HIV, including any such drug or biological approved for use as pre-exposure prophylaxis (commonly referred to as PrEP) or as post-exposure prophylaxis (commonly referred to as PEP); (2)administrative fees for such drugs and biologicals; (3)laboratory and other diagnostic procedures associated with the use of such drugs and biologicals; (4)counseling with respect to HIV prevention, including HIV risk assessment, HIV risk reduction, and medication adherence; and (5)clinical follow up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines, without limitation.. (10)Elimination of cost-sharing for drugs for the prevention of HIVWith respect to a covered part D drug that is for the prevention of HIV— (A)the deductible under paragraph (1) shall not apply; and (B)there shall be no coinsurance or other cost-sharing under this part with respect to such drug.; and (7)Treatment of cost-sharing for drugs for the prevention of HIVThe coverage is provided in accordance with subsection (b)(10).. (7)No application of cost-sharing or deductible for drugs for the prevention of HIVWith respect to a covered part D drug that is for the prevention of HIV— (A)the deductible under section 1860D–2(b)(1) shall not apply; and (B)there shall be no cost-sharing under this section with respect to such drug.. (ll)HIV prevention servicesFor purposes of subsection (a)(4)(G), the term HIV prevention services means prescription drugs approved by the Food and Drug Administration for the prevention of HIV, including any such drug approved for use as pre-exposure prophylaxis (commonly referred to as PrEP) or as post-exposure prophylaxis (commonly referred to as PEP), administrative fees for such drugs, laboratory and other diagnostic procedures associated with the use of such drugs, counseling with respect to HIV prevention (including HIV risk assessment, HIV risk reduction, and medication adherence), and clinical follow up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines, without limitation.. (xv)HIV prevention services described in section 1905(a)(4)(G).. (13)HIV prevention servicesRegardless of the type of coverage elected by a State under subsection (a), the child health assistance provided for a targeted low-income child, and, in the case of a State that elects to provide pregnancy-related assistance pursuant to section 2112, the pregnancy-related assistance provided for a targeted low-income pregnant woman (as such terms are defined for purposes of such section), shall include coverage of HIV prevention services (as defined in section 1905(ll)).. (c)Any health benefits plan offered under this chapter shall include benefits for, and may not impose any cost-sharing requirements for, any prescription drug approved by the Food and Drug Administration for the prevention of HIV, including any such drug approved for use as pre-exposure prophylaxis (commonly referred to as PrEP) or as post-exposure prophylaxis (commonly referred to as PEP), administrative fees for such drugs, laboratory and other diagnostic procedures associated with the use of such drugs, counseling with respect to HIV prevention (including HIV risk assessment, HIV risk reduction, and medication adherence), and clinical follow up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines, without limitation..

2729A. Prohibition on preauthorization requirements with respect to certain services A group health plan or a health insurance issuer offering group or individual health insurance coverage shall not impose any preauthorization requirements with respect to coverage of the services described in section 2713(a)(6), except that a plan or issuer may impose preauthorization requirements with respect to coverage of a particular drug approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act or section 351(a) of this Act if such plan or issuer provides coverage without any preauthorization requirements for a drug that is therapeutically equivalent.