PrEP Access and Coverage Act

To increase access to pre-exposure prophylaxis to reduce the transmission of HIV. 1. Short title This Act may be cited as the PrEP Access and Coverage Act 2. Findings; sense of Congress (a) Findings Congress finds as follows: (1) The Centers for Disease Control and Prevention estimates that approximately 1,100,000 people in the United States are living with HIV. (2) In 2019, there were 36,398 new diagnoses of HIV in the United States. (3) HIV disproportionately impacts gay and bisexual men, transgender women, and, in particular, people of color. For example, in 2019, approximately 66 percent of new HIV diagnoses were among gay and bisexual men, 42 percent of new HIV diagnoses were among Black people, and 22 percent of new HIV diagnoses were among Latinx people. Recent studies suggest that transgender women are up to 49 times more likely to be diagnosed with HIV than the general population. Members of communities at the intersections of these groups are most heavily impacted. (4) Pre-exposure prophylaxis (referred to in this section as PrEP (5) Many individuals at risk of exposure to HIV do not use PrEP. Of the approximately 1,100,000 people in the United States who could benefit from PrEP, only 23 percent, or nearly 285,000 individuals, filled prescriptions for the drug in 2019. (6) PrEP usage is inconsistent across racial and gender lines. In 2019, only 8 percent of Black/African American and 14 percent of Hispanic/Latinx persons who were eligible for PrEP were prescribed it, compared to 63 percent of White persons. Additionally, slightly less than 10 percent of women eligible for PrEP received a prescription in 2019. (7) There are currently 2 brand name drugs and 1 generic drug approved by the Food and Drug Administration for the use of PrEP on a daily basis. Other types of HIV prevention treatments, including a long-acting injectable, which is currently under FDA review, and long-acting oral pills, implants, and vaginal rings are in the research pipeline. These new innovations can increase widespread use of PrEP along with adherence, which can speed the Nation’s goal to end HIV and address inequities in health care. (8) Section 2713 of the Public Health Service Act ( 42 U.S.C. 300gg–13 A B A (9) Joint guidance issued by the Department of Labor, the Department of Health and Human Services, and the Department of the Treasury on July 19, 2021, clarifies that ancillary services necessary to maintain the PrEP regime, including subsequent provider visits, clinical testing, and other services, is required to be covered by health insurers without cost-sharing. (10) Permanently expanding access to cost-free PrEP and ancillary services for all individuals, including individuals who do not have health insurance, through legislation, is a critical step towards eliminating HIV transmission. (11) Post-exposure prophylaxis (referred to in this section as PEP (12) The Centers for Disease Control and Prevention recommends PEP for an individual who has experienced a high-risk exposure incident, provided that the individual tests HIV-negative, initiates such treatment no later than 72 hours after exposure, and continues the treatment for 28 days. (13) Despite PEP’s proven effectiveness in preventing HIV infection after high-risk sexual exposures, awareness of PEP is low among individuals who would benefit from the treatment. Studies suggest that awareness of PEP and of the importance of its prompt initiation is particularly low among young gay and bisexual men of color, transgender persons, and women of all gender identities. (14) Adequate knowledge of guidelines issued by the Centers for Disease Control and Prevention for assessing indications for PEP and for initiating and sustaining PEP are low among health care providers and staff. Because PEP is an emergency intervention, insufficient knowledge among providers and staff in hospital emergency rooms, urgent care centers, community health centers, and primary care physicians is of particular concern. (15) Private and public health insurance plans and programs frequently impose requirements for coverage of PEP, including pre-authorization requirements and requirements to obtain the medications through designated specialty pharmacies and mail-order programs that pose significant obstacles to timely initiation of treatment. (16) Insurance deductibles and co-payments for PEP medications create significant barriers to PEP utilization by many individuals who have experienced high-risk incidents. (b) Sense of Congress It is the sense of Congress that the Department of Labor, the Department of Health and Human Services, and the Department of the Treasury should ensure compliance with the requirements described in paragraphs (8) and (9) of subsection (a). 3. Coverage of HIV testing and prevention services (a) Private insurance (1) In general Section 2713(a)of the Public Health Service Act ( 42 U.S.C. 300gg–13(a) (A) in paragraph (2), by striking ; and (B) in paragraph (3), by striking the period and inserting a semicolon; (C) in paragraph (4), by striking the period and inserting a semicolon; (D) in paragraph (5), by striking the period and inserting ; and (E) by adding at the end the following: (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), 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. . (2) Prohibition on preauthorization requirements Subpart II of part A of title XXVII of the Public Health Service Act ( 42 U.S.C. 300gg–11 et seq. 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. . (b) Coverage under Federal Employees Health Benefits Program Section 8904 of title 5, United States Code, is amended by adding at the end the following: (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, 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. . (c) Medicaid (1) In general Section 1905 of the Social Security Act ( 42 U.S.C. 1396d (A) in subsection (a)(4)— (i) by striking ; and (D) ; (D) (ii) by striking ; and (E) ; (E) (iii) by striking ; and (F) ; (F) (iv) by striking the semicolon at the end and inserting ; and (G) HIV prevention services; (B) by adding at the end the following new subsection: (jj) HIV prevention services For purposes of subsection (a)(4)(G), the term HIV prevention services . (2) No cost-sharing Title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq. (A) in section 1916, by inserting HIV prevention services described in section 1905(a)(4)(G), section 1905(a)(4)(C), (B) in section 1916A(b)(3)(B), by adding at the end the following new clause: (xii) HIV prevention services described in section 1905(a)(4)(G). . (3) Inclusion in benchmark coverage Section 1937(b)(7) of the Social Security Act ( 42 U.S.C. 1396u–7(b)(7) (A) in the paragraph header, by inserting and HIV prevention services supplies (B) 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 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 (d) CHIP (1) In general Section 2103 of the Social Security Act ( 42 U.S.C. 1397cc (A) in subsection (a), by striking and (8) (8), (10), (11), and (12) (B) in subsection (c), by adding at the end the following new paragraph: (12) HIV prevention services 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)). . (2) No cost-sharing Section 2103(e)(2) of the Social Security Act ( 42 U.S.C. 1397cc(e)(2) HIV prevention services described in subsection (c)(12), or for pregnancy-related assistance (3) Effective date (A) In general Subject to subparagraph (A), the amendments made by subsection (c) and this subsection shall take effect on January 1, 2023. (B) Delay permitted if State legislation required In the case of a State plan approved under title XIX 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. (e) Coverage and elimination of cost-Sharing under Medicare (1) Coverage of HIV prevention services under part B (A) Coverage (i) In general Section 1861(s)(2) of the Social Security Act ( 42 U.S.C. 1395x(s)(2) (I) in subparagraph (GG), by striking and (II) in subparagraph (HH), by striking the period at the end and inserting ; and (III) by adding at the end the following new subparagraph: (II) HIV prevention services (as defined in subsection (lll)); . (ii) Definition Section 1861 of the Social Security Act ( 42 U.S.C. 1395x (lll) HIV prevention services The term HIV prevention services (1) drugs or biologicals approved by the Food and Drug Administration for the prevention of HIV; (2) administrative fees for such drugs; (3) laboratory and other diagnostic procedures associated with the use of such drugs; and (4) clinical follow up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines, without limitation. . (B) Elimination of coinsurance Section 1833(a)(1) of the Social Security Act ( 42 U.S.C. 1395l(a)(1) (i) by striking and (DD) (DD) (ii) by inserting before the semicolon at the end the following: and (EE) with respect to HIV prevention services (as defined in section 1861(lll)), 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) (C) Exemption from part B deductible Section 1833(b) of the Social Security Act ( 42 U.S.C. 1395l(b) (i) in paragraph (11), by striking and (ii) 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). (D) Effective date The amendments made by this paragraph shall apply to items and services furnished on or after January 1, 2023. (2) Elimination of cost-Sharing for drugs for the prevention of HIV under part D (A) In general Section 1860D–2(b) of the Social Security Act ( 42 U.S.C. 1395w–102(b) (i) in paragraph (1)(A), by striking The coverage Subject to paragraph (8), the coverage (ii) in paragraph (2)(A), by striking and (D) and (D) and paragraph (8) (iii) in paragraph (3)(A), by striking and (4) (4), and (8) (iv) in paragraph (4)(A)(i), by striking The coverage Subject to paragraph (8), the coverage (v) by adding at the end the following new paragraph: (8) Elimination of cost-sharing for drugs for the prevention of HIV (A) In general 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. (B) Cost-sharing For purposes of subparagraph (A), the elimination of cost-sharing shall include the following: (i) No application of deductible The waiver of the deductible under paragraph (1). (ii) No application of coinsurance The waiver of coinsurance under paragraph (2). (iii) No application of initial coverage limit The initial coverage limit under paragraph (3) shall not apply. (iv) No cost sharing above annual out-of-pocket threshold The waiver of cost sharing under paragraph (4). . (B) Conforming amendments to cost-sharing for low-income individuals Section 1860D–14(a) of the Social Security Act ( 42 U.S.C. 1395w–114(a) (i) in paragraph (1), in the matter preceding subparagraph (A), by striking In the case Subject to section 1860D–2(b)(8), in the case (ii) in paragraph (2), in the matter preceding subparagraph (A), by striking In the case Subject to section 1860D–2(b)(8), in the case (f) Coverage of HIV prevention treatment by Department of Veterans Affairs (1) Elimination of medication copayments Section 1722A(a) of title 38, United States Code, is amended by adding at the end the following new paragraph: (5) Paragraph (1) does not apply to a medication for the prevention of HIV. . (2) Elimination of hospital care and medical services copayments Section 1710 of such title is amended— (A) in subsection (f)— (i) by redesignating paragraph (5) as paragraph (6); and (ii) by inserting after paragraph (4) the following new paragraph (5): (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 (B) in subsection (g)(3), by adding at the end the following new subparagraph: (C) 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. . (3) Inclusion as preventive health service Section 1701(9) of such title is amended— (A) in subparagraph (K), by striking ; and (B) by redesignating subparagraph (L) as subparagraph (M); and (C) by inserting after subparagraph (K) the following new subparagraph (L): (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 . (g) Coverage of HIV prevention treatment by Department of Defense (1) In general Chapter 55 section 1079c 1079d. Coverage of HIV prevention treatment (a) In general 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. (b) HIV prevention treatment described 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. (c) No cost-Sharing 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. . (2) Clerical amendment 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. . (h) Indian health service testing, monitoring, and prescription drugs for the prevention of HIV The Indian Health Care Improvement Act is amended by inserting after section 223 ( 25 U.S.C. 1621v 224. Testing, monitoring, and prescription drugs for the prevention of HIV (a) In general The Secretary, acting through the Service, Indian tribes, and tribal organizations, shall provide funding for any prescription drug approved by the Food and Drug Administration for the prevention of human immunodeficiency virus (commonly known as HIV (b) Authorization of appropriations There are authorized to be appropriated such sums as may be necessary to carry out this section. . (i) Effective date The amendments made by subsections (a), (b), (e), (f), (g), and (h) shall take effect with respect to plan years beginning on or after January 1, 2023. 4. Prohibition on denial of coverage or increase in premiums of life, disability, or long-term care insurance for individuals taking medication for the prevention of HIV acquisition (a) Prohibition Notwithstanding any other provision of law, it shall be unlawful to— (1) 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; (2) 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; (3) 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 (4) 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. (b) Enforcement A State insurance regulator may take such actions to enforce subsection (a) as are specifically authorized under the laws of such State. (c) Definitions In this section: (1) Disability insurance policy The term disability insurance policy (2) Life insurance policy The term life insurance policy (3) Long-term care insurance policy The term long-term care insurance policy section 7702B(c) 5. Public education campaign Part P of title III of the Public Health Service Act ( 42 U.S.C. 280g et seq. 399V–7. Pre-exposure prophylaxis and post-exposure prophylaxis education campaigns (a) Public education campaign (1) In general The Secretary, acting through the Director of the Centers for Disease Control and Prevention, in consultation with the Director of the Office of Infectious Disease and HIV/AIDS Policy, shall establish a public health campaign for the purpose of educating the public on medication for the prevention of HIV acquisition. (2) Requirements In carrying out this subsection, the Secretary shall ensure cultural competency and efficacy within high-need communities in which PrEP or PEP are underutilized by developing the campaign in collaboration with organizations that are indigenous to communities that are overrepresented in the domestic HIV epidemic, including communities of color and the lesbian, gay, bisexual, transgender, and queer community. The Secretary shall ensure that the campaign is designed to increase awareness of the safety and effectiveness of PrEP and PEP, the recommended clinical practices for providing PrEP-related and PEP-related clinical care, and the local availability of PrEP and PEP providers, and to counter stigma associated with the use of PrEP and PEP. (3) Evaluation of program The Secretary shall develop measures to evaluate the effectiveness of activities conducted under this subsection that are aimed at reducing disparities in access to PrEP and PEP and supporting the local community. Such measures shall evaluate community outreach activities, language services, workforce cultural competence, and other areas as determined by the Secretary. (b) Provider education campaign (1) In general The Secretary, acting through the Director of the Centers for Disease Control and Prevention and the Administration of the Health Resources Services Administration and the Office of Infectious Disease and HIV/AIDS Policy, shall establish a provider campaign for the purpose of educating prescribers and other associated health professionals on medication for the prevention of HIV acquisition. (2) Requirements In carrying out this subsection, the Secretary shall increase awareness and readiness among health care providers to offer PrEP or PEP, as appropriate, with a focus on areas of high-need communities in which PrEP or PEP is underutilized by developing an educational campaign with input from health care providers and organizations that are indigenous to communities that are overrepresented in the domestic HIV epidemic, including communities of color and the lesbian, gay, bisexual, transgender, and queer community. The Secretary shall ensure that the campaign is designed to increase awareness of the safety and effectiveness of PrEP and PEP, the recommended clinical practices for providing PrEP-related and PEP-related clinical care, cultural competency among PrEP and PEP prescribers, and to counter stigma associated with the use of PrEP and PEP. (3) Evaluation of program The Secretary shall develop measures to evaluate the effectiveness of activities conducted under this subsection that are aimed at increasing the number of health care professionals offering PrEP and PEP and reducing disparities in access to PrEP and PEP. Such measures shall evaluate availability of PrEP and PEP services, education and outreach activities, language services, workforce cultural competence, and other areas as determined by the Secretary. (c) Definitions In this section and section 399V–8— (1) the term PEP (2) the term PrEP (d) Authorization of appropriations 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. . 6. Patient confidentiality 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 7. Pre-exposure prophylaxis and post-exposure prophylaxis funding Part P of title III of the Public Health Service Act ( 42 U.S.C. 280g et seq. 399V–8. Pre-exposure prophylaxis and post-exposure prophylaxis funding (a) In general Not later than 1 year after the date of enactment of the PrEP Access and Coverage Act PrEP PEP (b) Applications To be eligible to receive a grant under subsection (a), a State, territory, Indian Tribe, or directly eligible entity shall— (1) 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 (2) appoint a PrEP and PEP grant administrator to manage the program. (c) Directly eligible entity For purposes of this section, the term directly eligible entity (1) means a Federally qualified health center or other nonprofit entity engaged in providing PrEP and PEP information and services; and (2) may include— (A) a Federally qualified health center (as defined in section 1861(aa)(4) of the Social Security Act ( 42 U.S.C. 1395x(aa)(4) (B) a family planning grantee (other than States) funded under section 1001 of the Public Health Service Act ( 42 U.S.C. 300 (C) a rural health clinic (as defined in section 1861(aa)(2) of the Social Security Act ( 42 U.S.C. 1395x(aa)(2) (D) a health facility operated by or pursuant to a contract with the Indian Health Service; (E) a community-based organization, clinic, hospital, or other health facility that provides services to individuals at risk for or living with HIV; and (F) a nonprofit private entity providing comprehensive primary care to populations at risk of HIV, including faith-based and community-based organizations. (d) Awards 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. (e) Use of funds (1) In general 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. (2) Eligible prep 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— (A) 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; (B) 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 (C) outreach activities directed toward physicians and other providers that provide education about PrEP and PEP. (f) Report to Congress The Secretary shall, in each of the first 5 years beginning one year after the date of the enactment of the PrEP Access and Coverage Act (g) Authorization of Appropriations 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. . 8. Clarification This Act, including the amendments made by this Act, shall apply notwithstanding any other provision of law, including Public Law 103–141 9. Private right of action Any person aggrieved by a violation of this Act, including the amendments made by this Act, 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.

Summary: PrEP Access and Coverage Act This bill requires private health insurance plans to cover prescription drugs that prevent HIV, including related screenings, diagnostic procedures, administrative fees, and clinical follow-ups, without any cost-sharing obligation for the plan holder. Further, insurance plans must not impose any preauthorization requirement for this coverage. These coverage requirements also apply to public health insurance programs, including Medicare, Medicaid, and the Children's Health Insurance Program. Additionally, the bill prohibits denying, limiting, or qualifying coverage or increasing premiums for disability insurance, long-term care insurance, or life insurance policies based on an individual taking medication for HIV prevention. The bill further requires the Department of Health and Human Services to award grants to states, or directly to eligible local organizations, to provide uninsured individuals and underinsured individuals access to prescription drugs and related services that prevent HIV. The Centers for Disease Control and Prevention also must develop a public awareness campaign that focuses efforts in communities with a high need for HIV prevention treatment.