II 116th CONGRESS 1st Session S. 1926 IN THE SENATE OF THE UNITED STATES June 20, 2019 Ms. Harris introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL 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 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 2017, there were 38,281 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 2017 approximately 66 percent of new HIV diagnoses were among gay and bisexual men, 43 percent of new HIV diagnoses were among Black people, and 26 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 ) is a daily antiretroviral medication that helps prevent individuals from acquiring HIV. Daily PrEP use reduces the risk of getting HIV from sex by over 90 percent. It reduces the risk of getting HIV from injection drug use by over 70 percent. (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 7 percent, or 78,360 individuals, filled prescriptions for the drug in 2016. (6) PrEP usage is inconsistent across racial and gender lines. In 2016, PrEP users were 68.7 percent White, 11.2 percent Black, and 13.1 percent Latinx. However, individuals eligible for PrEP were 26.3 percent White, 43.7 percent Black, and 24.7 percent Latinx. Additionally, only 2.1 percent of women eligible for PrEP received a prescription in 2016. (7) There is currently only one version of PrEP approved by the Food and Drug Administration, marketed under the brand name of Truvada, which, in 2018, had a list price of over $20,000 a year in the United States. A less expensive, generic version of PrEP is expected to be available in September 2020, and other types of HIV prevention treatments, including oral pills, vaginal rings, and long-acting injectables, are currently in the research pipeline. (8) Section 2713 of the Public Health Service Act ( 42 U.S.C. 300gg–13 ) requires most private health insurance plans to cover preventive services without cost-sharing, including such services with a rating of A or B under recommendations of the United States Preventive Services Task Force. On June 11, 2019, the United States Preventive Services Task Force issued a final recommendation giving an A grade for PrEP for individuals at high risk of HIV; non-grandfathered private health insurance plans will have to cover PrEP for such individuals without cost-sharing by 2021. (9) Despite such recommendation of the United States Preventive Services Task Force, access barriers to PrEP remain. Ancillary services necessary to maintain the PrEP regime, including subsequent provider visits, clinical testing, and other services, can remain a cost-burden on patients. Additionally, the new recommendations are not linked to coverage requirements for individuals with other types of insurance, such as Medicare or Medicaid. (10) Expanding access to cost-free PrEP and ancillary services for all individuals, including individuals who do not have health insurance, is a critical step towards eliminating HIV transmission. 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) ) is amended— (A) in paragraph (2), by striking ; and and inserting a semicolon; (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 ; 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 acquisition, 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.) is amended by adding at the end the following: 2729. 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 pre-authorization requirements with respect to coverage of the services described in section 2713(a)(6). . (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 acquisition, 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 ) is amended— (A) in subsection (a)(4)— (i) by striking and (D) and inserting (D) ; and (ii) by inserting ; and (E) HIV prevention services before the semicolon; and (B) by adding at the end the following new subsection: (ff) HIV prevention services For purposes of subsection (a)(4)(E), the term HIV prevention services means prescription drugs for the prevention of HIV acquisition, 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) No cost sharing Title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq.) is amended— (A) in section 1916, by inserting HIV prevention services described in section 1905(a)(4)(E), after section 1905(a)(4)(C), each place it appears; and (B) in section 1916A(b)(3)(B), by adding at the end the following new clause: (xi) HIV prevention services described in section 1905(a)(4)(E). . (3) Inclusion in benchmark coverage Section 1937(b)(7) of the Social Security Act ( 42 U.S.C. 1396u–7(b)(7) ) is amended— (A) in the paragraph header, by inserting and HIV prevention services after supplies ; and (B) by inserting , and, for any individual described in section 1905(a)(4)(E), medical assistance for HIV prevention services in accordance with such section before the period. (d) CHIP (1) In general Section 2103(c) of the Social Security Act ( 42 U.S.C. 1397cc(c) ), as amended by section 5022 of the SUPPORT for Patients and Communities Act ( Public Law 115–271 ), is amended by adding at the end the following new paragraph: (10) HIV prevention services The child health assistance provided to a targeted low-income child and the pregnancy-related assistance provided to a targeted low-income woman shall include coverage of HIV prevention services (as defined in section 1905(ff)). . (2) No cost sharing Section 2103(e)(2) of the Social Security Act ( 42 U.S.C. 1397cc(e)(2) ) is amended by inserting , for HIV prevention services described in subsection (c)(10), after subsection (c)(1)(D) . (3) Conforming amendment Section 2103(a) of the Social Security Act ( 42 U.S.C. 1397cc(a) ), as amended by section 5022 of the SUPPORT for Patients and Communities Act ( Public Law 115–271 ), is amended in the matter preceding paragraph (1) by striking and (8) and inserting (8), and (10) . (4) Effective date (A) In general Subject to subparagraph (A), the amendments made by subsection (c) and this subsection shall take effect on January 1, 2021. (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) Waiver of cost-Sharing under Medicare (1) Part B (A) Inclusion as a preventive service Section 1861(ddd)(3) of the Social Security Act ( 42 U.S.C. 1395x(ddd)(3) ) is amended by adding at the end the following new subparagraph: (D) Drugs or biologicals approved by the Food and Drug Administration for the prevention of HIV acquisition, 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) Elimination of coinsurance Section 1833(a)(1) of the Social Security Act ( 42 U.S.C. 1395l(a)(1) ) is amended— (i) by striking and (CC) and inserting (CC) ; and (ii) by inserting before the semicolon at the end the following: , and (DD) with respect to preventive services described in subparagraph (D) of section 1861(ddd)(3), 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 treatment 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) ) is amended— (i) in paragraph (9), by striking and at the end; and (ii) in paragraph (10), by striking the period at the end and inserting , and (11) such deductible shall not apply with respect to preventive services described in subparagraph (D) of section 1861(ddd)(3). . (D) Effective date The amendments made by this paragraph shall apply to items and services furnished on or after January 1, 2021. (2) Part D (A) In general Section 1860D–2(b) of the Social Security Act ( 42 U.S.C. 1395w–102(b) ) is amended— (i) in paragraph (1)(A), by striking The coverage and inserting Subject to paragraph (8), the coverage ; (ii) in paragraph (2)(A), by striking and (D) and inserting and (D) and paragraph (8) ; (iii) in paragraph (3)(A), by striking and (4) and inserting (4), and (8) ; (iv) in paragraph (4)(A)(i), by striking The coverage and inserting Subject to paragraph (8), the coverage ; and (v) by adding at the end the following new paragraph: (8) Limitations on cost-sharing for drugs for the prevention of HIV acquisition (A) In general For plan year 2021 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 acquisition. (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) ) is amended— (i) 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 (ii) 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 . (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 acquisition. . (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 acquisition, 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 acquisition, 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 and inserting a semicolon; (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 acquisition, 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 of title 10, United States Code, is amended by inserting after section 1079c the following new section: 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 acquisition, 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 acquisition The Indian Health Care Improvement Act is amended by inserting after section 223 ( 25 U.S.C. 1621v ) the following: 224. Testing, monitoring, and prescription drugs for the prevention of HIV acquisition (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 HIV acquisition, 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) Authorization of appropriations There are authorized to be appropriated to carry out this section such sums as may be necessary. . (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, 2021. 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 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. (2) Life insurance policy 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. (3) Long-term care insurance policy 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). 5. Public education campaign Part P of title III of the Public Health Service Act ( 42 U.S.C. 280g et seq.) is amended by adding at the end the following: 399V–7. Pre-exposure prophylaxis public education campaign (a) In general The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish a public health campaign for the purpose of educating the public on medication for the prevention of HIV acquisition. (b) Requirements In carrying out this section, the Secretary shall ensure cultural competency and efficacy within high-need communities in which PrEP is 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, the recommended clinical practices for providing PrEP-related clinical care, and the local availability of PrEP providers, and to counter stigma associated with the use of PrEP. (c) Evaluation of program The Secretary shall develop measures to evaluate the effectiveness of activities conducted under this section that are aimed at reducing disparities in access to PrEP 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. (d) PrEP In this section, the term PrEP means any drug approved by the Food and Drug Administration for the purpose of pre-exposure prophylaxis with respect to HIV. (e) Authorization of appropriations There are authorized to be appropriated such sums as may be necessary for each of fiscal years 2021 through 2026. . 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 note), as necessary, to ensure that individuals are able to access the benefits described in section 2713(a)(6) under a family plan without any other individual enrolled in such family plan, including a primary subscriber of or policyholder, being informed of such use of such benefits. 7. Pre-exposure prophylaxis funding (a) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (in this Act referred to as the Secretary ) shall establish a program that provides grants to States, territories, and Indian Tribes for the establishment and support of pre-exposure prophylaxis (referred to in this section as PrEP ) programs, or establishes a program for providing Federal funding directly to eligible entities within a State, territory, or Indian Tribal territory, in the case of a State, territory, or Indian Tribe that does not apply for such a grant. (b) Grant program (1) Applications To be eligible to receive a grant under subsection (a), a State, territory, or Indian Tribe shall— (A) submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require, including a description of how any funds awarded will be used and a plan describing how any funds awarded will be used to increase access to PrEP for uninsured individuals and reduce disparities in access to PrEP; and (B) appoint a PrEP grant administrator to manage the program. (2) Use of funds Any State, Territory of the United States, or Indian Tribe that is awarded funds under subsection (a) shall use such funds for eligible PrEP expenses. (c) Federal program (1) In general In the case of a State, territory, or Indian Tribe that does not submit an application under subsection (b), the Secretary shall provide funding to any of the following, within the applicable State, territory, or Indian Tribal territory: (A) Federally qualified health centers (as defined in section 1861(aa)(4) of the Social Security Act ( 42 U.S.C. 1395x(aa)(4) ). (B) Family planning grantees (other than States) funded under section 1001 of the Public Health Service Act ( 42 U.S.C. 300 ). (C) Rural health clinics (as defined in section 1861(aa)(2) of the Social Security Act ( 42 U.S.C. 1395x(aa)(2) ). (D) Health facilities operated by or pursuant to a contract with the Indian Health Service. (E) Community-based organizations, clinics, hospitals, and other health facilities that provide services to individuals at risk for or living with HIV. (F) Nonprofit private entities providing comprehensive primary care to populations at risk of HIV, including faith-based and community-based organizations. (2) Use of funds Any entity receiving funding under paragraph (1) shall use such funds for eligible PrEP expenses. (d) Eligible PrEP expenses (1) In general The Secretary shall publish a list of expenses that qualify as eligible PrEP expenses for purposes of this section. (2) Inclusions Such list shall include— (A) any prescription drug approved by the Food and Drug Administration for the prevention of HIV acquisition, 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, provide education about access to and health care coverage of PrEP, and counter stigma associated with the use of PrEP; and (C) outreach activities directed toward physicians and other providers that provide education about PrEP. (e) Report to Congress The Secretary shall, in each of the first 5 years beginning one year after the date of the enactment of this Act, submit to Congress, and make public on the internet website of Department of Health and Human Services, a report on the impact of any grants provided to States, territories, and Indian Tribes for the establishment and support of pre-exposure prophylaxis programs under this section. (f) Authorization of Appropriations There are authorized to be appropriated to carry out this section $60,000,000 for each of the first 5 fiscal years beginning after the date of the enactment of this section. 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.