Sec. 7220. PrEP access and coverage

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A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

r EP access and coverage 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), administrative fees for such drugs, laboratory and other diagnostic procedures associated with the use of such drugs, 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. ), as amended by section 7602(d), 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)(1)(E), 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. .

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, administrative fees for such drugs, laboratory and other diagnostic procedures associated with the use of such drugs, and clinical follow-up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines, without limitation. .

Section 1905 of the Social Security Act ( 42 U.S.C. 1396d ), as previously amended by this Act, 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 for the prevention of HIV acquisition, administrative fees for such drugs, laboratory and other diagnostic procedures associated with the use of such drugs, 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 after and HIV prevention services ; and supplies 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 2007(d)(5), is amended— in subsection (a), by striking and

(12)and inserting (12), 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(jj)). . 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 clause (ii), the amendments made by paragraph

(3)and this paragraph shall take effect on January 1, 2023. 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 subsection, 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 Act. 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 1861(s)(2) of the Social Security Act ( 42 U.S.C. 1395x(s)(2) ), as amended by section 4251(c)(1) and 6011(a)(1), is amended— in subparagraph (II), by striking and at the end; in subparagraph (JJ), by striking the period at the end and inserting ; and ; and by adding at the end the following new subparagraph: HIV prevention services (as defined in subsection (ppp)); . Section 1861 of the Social Security Act ( 42 U.S.C. 1395x ), as amended by sections 2007(b), 4221(a), 4251(c)(2), and 6011(a)(2), 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; administrative fees for such drugs; laboratory and other diagnostic procedures associated with the use of such drugs; 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) ), as amended by sections 4251(c)(3) and 6011(a)(4), is amended— by striking and and before

(FF); and by inserting before the semicolon at the end the following: and

(GG)with respect to HIV prevention services (as defined in section 1861(ppp)), 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). Section 1833(b) of the Social Security Act ( 42 U.S.C. 1395l(b) ) is amended— in paragraph (11), by striking and at the end; and in paragraph (12), by striking the period at the end and inserting , and

(13)such deductible shall not apply with respect to HIV prevention services (as defined in section 1861(lll). . The amendments made by this subparagraph shall apply to items and services furnished on or after January 1, 2023. Section 1860D–2(b) of the Social Security Act ( 42 U.S.C. 1395w–102(b) ) is amended— in paragraph (1)(A), in the matter preceding clause (i), by striking The coverage and inserting Subject to paragraph (8), the coverage ; in paragraph (2)— in subparagraph (A), in the matter preceding clause (i), by striking and

(D)and inserting and

(D)and paragraph

(8); in subparagraph (C)(i), in the matter preceding subclause (I), by striking paragraph

(4)and inserting paragraphs

(4)and

(8); and in subparagraph (D)(i), in the matter preceding subclause (I), by striking paragraph

(4)and inserting paragraphs

(4)and

(8); in paragraph (3)(A), in the matter preceding clause (i), by striking and

(4)and inserting (4), and

(8); in paragraph (4)(A)(i), in the matter preceding subclause (I), by striking The coverage and inserting Subject to paragraph (8), the coverage ; and by adding at the end the following new paragraph: For plan year 2023 and each subsequent plan year, there shall be no cost-sharing under this part (including under section 1814D–14) for covered part D drugs that are for the prevention of HIV. For purposes of subparagraph (A), the elimination of cost-sharing shall include the following: The waiver of the deductible under paragraph (1). The waiver of coinsurance under paragraph (2). The initial coverage limit under paragraph

(3)shall not apply. The waiver of cost-sharing under paragraph (4). . Section 1860D–14(a) of the Social Security Act ( 42 U.S.C. 1395w–114(a) ) is amended— in paragraph (1), in the matter preceding subparagraph (A), by striking In the case and inserting Subject to section 1860D–2(b)(8), in the case ; and in paragraph (2), in the matter preceding subparagraph (A), by striking In the case and inserting Subject to section 1860D–2(b)(8), in the case . Section 1722A(a) of title 38, United States Code, is amended by adding at the end the following new paragraph: Paragraph

(1)does not apply to a medication for the prevention of HIV. . Section 1710 of such title is amended— in subsection (f)— by redesignating paragraph

(5)as paragraph (6); and by inserting after paragraph

(4)the following new paragraph (5): A veteran shall not be liable to the United States under this subsection for any amounts for laboratory and other diagnostic procedures associated with the use of any prescription drug approved by the Food and Drug Administration for the prevention of HIV, administrative fees for such drugs, or for laboratory or other diagnostic procedures associated with the use of such drugs, or clinical follow-up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines, without limitation. ; and in subsection (g)(3), by adding at the end the following new subparagraph: Any prescription drug approved by the Food and Drug Administration for the prevention of HIV, administrative fees for such drugs, laboratory and other diagnostic procedures associated with the use of such drugs, and clinical follow-up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines, without limitation. . Section 1701(9) of such title is amended— in subparagraph (K), by striking ; and and inserting a semicolon; by redesignating subparagraph

(L)as subparagraph (M); and by inserting after subparagraph

(K)the following new subparagraph (L): any prescription drug approved by the Food and Drug Administration for the prevention of HIV, administrative fees for such drugs, laboratory and other diagnostic procedures associated with the use of such drugs, and clinical follow-up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines, without limitation; and . Chapter 55 of title 10, United States Code, is amended by inserting after section 1079c the following new section: The Secretary of Defense shall ensure coverage under the TRICARE program of HIV prevention treatment described in subsection

(b)for any beneficiary under section 1074(a) of this title. HIV prevention treatment described in this subsection includes any prescription drug approved by the Food and Drug Administration for the prevention of HIV, administrative fees for such drugs, laboratory and other diagnostic procedures associated with the use of such drugs, and clinical follow-up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines, without limitation. Notwithstanding section 1075, 1075a, or 1074g(a)(6) of this title or any other provision of law, there is no cost-sharing requirement for HIV prevention treatment covered under this section. . The table of sections at the beginning of such chapter is amended by inserting after the item relating to section 1079c the following new item: 1079d. Coverage of HIV prevention treatment. . Title II of the Indian Health Care Improvement Act is amended by inserting after section 223 ( 25 U.S.C. 1621v ) the following: The Secretary, acting through the Service, Indian tribes, and tribal organizations, shall provide, without limitation, funding for any prescription drug approved by the Food and Drug Administration for the prevention of human immunodeficiency virus (commonly known as HIV ), administrative fees for that drug, laboratory and other diagnostic procedures associated with the use of that drug, and clinical follow-up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines. There are authorized to be appropriated such sums as may be necessary to carry out this section. . The amendments made by paragraphs (1), (2), (5), (6), (7), and

(8)shall take effect with respect to plan years beginning on or after January 1, 2023. Notwithstanding any other provision of law, it shall be unlawful to— decline or limit coverage of a person under any life insurance policy, disability insurance policy, or long-term care insurance policy, on account of the individual taking medication for the purpose of preventing the acquisition of HIV; preclude an individual from taking medication for the purpose of preventing the acquisition of HIV as a condition of receiving a life insurance policy, disability insurance policy, or long-term care insurance policy; consider whether an individual is taking medication for the purpose of preventing the acquisition of HIV in determining the premium rate for coverage of such individual under a life insurance policy, disability insurance policy, or long-term care insurance policy; or otherwise discriminate in the offering, issuance, cancellation, amount of such coverage, price, or any other condition of a life insurance policy, disability insurance policy, or long-term care insurance policy for an individual, based solely and without any additional actuarial risks upon whether the individual is taking medication for the purpose of preventing the acquisition of HIV. A State insurance regulator may take such actions to enforce paragraph

(1)as are specifically authorized under the laws of such State. In this subsection: The term disability insurance policy means a contract under which an entity promises to pay a person a sum of money in the event that an illness or injury resulting in a disability prevents such person from working. The term life insurance policy means a contract under which an entity promises to pay a designated beneficiary a sum of money upon the death of the insured. The term long-term care insurance policy means a contract for which the only insurance protection provided under the contract is coverage of qualified long-term care services (as defined in section 7702B(c) of the Internal Revenue Code of 1986). The Secretary of Health and Human Services shall amend the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 ( 42 U.S.C. 1320d–2 note), as necessary, to ensure that individuals are able to access the benefits described in section 2713(a)(1)(E) of the Public Health Service Act (as amended by section 7602(d)) under a family plan without any other individual enrolled in such family plan, including a primary subscriber or policyholder of such plan, being informed of such use of such benefits. Part P of title III of the Public Health Service Act ( 42 U.S.C. 280g et seq. ), as amended by section 7153, is further amended by adding at the end the following: Not later than 1 year after the date of enactment of this section, the Secretary shall establish a program that awards grants to States, territories, Indian Tribes, and directly eligible entities for the establishment and support of pre-exposure prophylaxis (referred to in this section as PrEP ) and post-exposure prophylaxis (referred to in this section as PEP ) HIV programs. To be eligible to receive a grant under subsection (a), a State, territory, Indian Tribe, or directly eligible entity shall— submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require, including a plan describing how any funds awarded will be used to increase access to PrEP for uninsured and underinsured individuals and reduce disparities in access to PrEP and PEP for uninsured and underinsured individuals and reduce disparities in access to PrEP and PEP; and appoint a PrEP and PEP grant administrator to manage the program. For purposes of this section, the term directly eligible entity — means a Federally qualified health center or other nonprofit entity engaged in providing PrEP and PEP information and services; and may include— a Federally qualified health center (as defined in section 1861(aa)(4) of the Social Security Act ( 42 U.S.C. 1395x(aa)(4) )); a family planning grantee (other than States) funded under section 1001 of the Public Health Service Act ( 42 U.S.C. 300 ); a rural health clinic (as defined in section 1861(aa)(2) of the Social Security Act ( 42 U.S.C. 1395x(aa)(2) )); a health facility operated by or pursuant to a contract with the Indian Health Service; a community-based organization, clinic, hospital, or other health facility that provides services to individuals at risk for or living with HIV; and a nonprofit private entity providing comprehensive primary care to populations at risk of HIV, including faith-based and community-based organizations. In determining whether to award a grant, and the grant amount for each grant awarded, the Secretary shall consider the grant application and the need for PrEP and PEP services in the area, the number of uninsured and underinsured individuals in the area, and how the State, territory, or Indian Tribe coordinates PrEP and PEP activities with the directly funded entity, if the State, territory, or Indian Tribe applies for the funds. Any State, territory, Indian Tribe, or directly eligible entity that is awarded funds under subsection

(a)shall use such funds for eligible PrEP and PEP expenses. The Secretary shall publish a list of expenses that qualify as eligible PrEP and PEP expenses for purposes of this section, which shall include— any prescription drug approved by the Food and Drug Administration for the prevention of HIV, administrative fees for such drugs, laboratory and other diagnostic procedures associated with the use of such drugs, and clinical follow-up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines, without limitation; outreach and public education activities directed toward populations overrepresented in the domestic HIV epidemic that increase awareness about the existence of PrEP and PEP, provide education about access to and health care coverage of PrEP and PEP, PrEP and PEP adherence programs, and counter stigma associated with the use of PrEP and PEP; and outreach activities directed toward physicians and other providers that provide education about PrEP and PEP. The Secretary shall, in each of the first 5 years beginning one year after the date of the enactment of this section, submit to Congress, and make public on the internet website of the Department of Health and Human Services, a report on the impact of any grants provided to States, territories, and Indian Tribes and directly eligible entities for the establishment and support of pre-exposure prophylaxis programs under this section. To carry out this section, there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2023 through 2028. . This section, including the amendments made by this section, shall apply notwithstanding any other provision of law, including Public Law 103–141 . Any person aggrieved by a violation of this section, including the amendments made by this section, may commence a civil action in an appropriate United States District Court or other court of competent jurisdiction to obtain relief as allowed by law as either an individual or member of a class. If the plaintiff is the prevailing party in such an action, the court shall order the defendant to pay the costs and reasonable attorney fees of the plaintiff.

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