[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4392 Introduced in House (IH)]

<DOC>






118th CONGRESS
  1st Session
                                H. R. 4392

     To increase access to pre-exposure prophylaxis to reduce the 
                          transmission of HIV.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 27, 2023

Mr. Schiff (for himself, Mr. Bera, Mr. Beyer, Mr. Bowman, Ms. Bush, Mr. 
Carbajal, Mr. Carson, Mr. Casten, Ms. Chu, Mr. Cohen, Mr. Connolly, Ms. 
Davids of Kansas, Ms. Dean of Pennsylvania, Mr. Doggett, Mr. Espaillat, 
Mr. Evans, Ms. Garcia of Texas, Mr. Garcia of Illinois, Mr. Gomez, Mr. 
  Gottheimer, Mr. Grijalva, Mr. Huffman, Ms. Jacobs, Ms. Jayapal, Mr. 
Johnson of Georgia, Ms. Lee of California, Mr. Lynch, Ms. McCollum, Mr. 
McGovern, Ms. Moore of Wisconsin, Mr. Moulton, Mr. Neguse, Ms. Norton, 
  Mr. Panetta, Mr. Pascrell, Ms. Pingree, Mr. Pocan, Ms. Porter, Mr. 
    Quigley, Ms. Scanlon, Ms. Sewell, Mr. Stanton, Ms. Stevens, Ms. 
Strickland, Mr. Takano, Ms. Titus, Mr. Torres of New York, Mrs. Torres 
 of California, Mr. Trone, Ms. Underwood, Ms. Velazquez, Ms. Wasserman 
 Schultz, Mrs. Watson Coleman, and Ms. Wild) introduced the following 
 bill; which was referred to the Committee on Energy and Commerce, and 
in addition to the Committees on Oversight and Accountability, Ways and 
Means, Veterans' Affairs, Armed Services, Natural Resources, Financial 
     Services, and Education and the Workforce, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
  of such provisions as fall within the jurisdiction of the committee 
                               concerned

_______________________________________________________________________

                                 A BILL


 
     To increase access to pre-exposure prophylaxis to reduce the 
                          transmission of HIV.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``PrEP Access and Coverage Act of 
2023''.

SEC. 2. FINDINGS; SENSE OF CONGRESS.

    (a) Findings.--Congress finds the following:
            (1) The Centers for Disease Control and Prevention 
        estimates that approximately 1,200,000 individuals in the 
        United States are living with HIV.
            (2) In 2021, there were 36,136 new diagnoses of HIV in the 
        United States.
            (3) HIV disproportionately impacts gay and bisexual men, 
        transgender women, and, in particular, people of color. In 
        2021, approximately 71 percent of new HIV diagnoses were 
        estimated to be among gay and bisexual men, 40 percent of new 
        HIV diagnoses were among Black people, and 29 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 more than 99 percent. It 
        reduces the risk of getting HIV from injection drug use by at 
        least 74 percent.
            (5) Many individuals at risk of exposure to HIV do not use 
        PrEP. Of the approximately 1,200,000 individuals in the United 
        States who could benefit from PrEP, only 31 percent, or 382,364 
        individuals, filled prescriptions for the drug in 2022.
            (6) PrEP usage is inconsistent across racial and gender 
        lines. In 2022, only 11 percent of Black/African American and 
        21 percent of Hispanic/Latinx individuals who were eligible for 
        PrEP were prescribed it, compared to 82 percent of eligible 
        White individuals. PrEP usage is low among women, in particular 
        among heterosexual women of color, slightly less than 12 
        percent of women eligible for PrEP received a prescription in 
        2022.
            (7) PrEP use helps strengthen families by allowing couples 
        with partners of different HIV statuses to prevent the 
        transmission of HIV.
            (8) 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. A long-acting injectable PrEP drug 
        has also been approved by the Food and Drug Administration. 
        Other types of HIV prevention treatments, including other long-
        acting injectables, long-acting oral pills, implants, and 
        vaginal rings are in the research pipeline. These 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.
            (9) Section 2713 of the Public Health Service Act (42 
        U.S.C. 300gg-13) requires non-grandfathered 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 have to 
        cover PrEP for such individuals without cost-sharing effective 
        January 2021. Updated United States Preventive Service Task 
        Force guidance incorporating the new long-acting injectable 
        PrEP drug is pending.
            (10) 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.
            (11) 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.
            (12) Post-exposure prophylaxis (referred to in this section 
        as ``PEP'') is a daily antiretroviral treatment which, when 
        initiated promptly after a sexual or other exposure to blood or 
        body fluids that are associated with a high risk of HIV 
        transmission, is highly effective at preventing HIV 
        transmission.
            (13) 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 not later than 72 hours 
        after exposure, and continues the treatment for 28 days.
            (14) Despite PEP's proven effectiveness in preventing HIV 
        transmission after high-risk sexual exposures, including sexual 
        assault, 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 individuals, and women of all gender identities.
            (15) 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.
            (16) 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.
            (17) Insurance deductibles and co-payments for PEP 
        medications create significant barriers to PEP utilization by 
        many individuals who have experienced high-risk incidents.
            (18) The Federal Government has a compelling interest in 
        preventing new cases of HIV. Lowering the prevalence of HIV 
        protects public health and saves on the cost of HIV treatment.
    (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).

SEC. 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 (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.) is amended by adding at the end 
        the following:

``SEC. 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) is amended--
                    (A) in subsection (a)(4)--
                            (i) by striking ``; and (D)'' and inserting 
                        ``; (D)'';
                            (ii) by striking ``; and (E)'' and 
                        inserting ``; (E)'';
                            (iii) by striking ``; and (F)'' and 
                        inserting ``; (F)''; and
                            (iv) by striking the semicolon at the end 
                        and inserting ``; and (G) HIV prevention 
                        services;''; and
                    (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' 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.''.
            (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)(G),'' 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:
                            ``(xv) 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)) is amended--
                    (A) in the paragraph header, by inserting ``and hiv 
                prevention services'' after ``supplies''; and
                    (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'' 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''.
    (d) CHIP.--
            (1) In general.--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--
                    (A) in subsection (a), by striking ``and (8)'' and 
                inserting ``(8), (10), (11), and (13)''; and
                    (B) in subsection (c), by adding at the end the 
                following new paragraph:
            ``(13) 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)) is amended by inserting 
        ``HIV prevention services described in subsection (c)(13),'' 
        before ``or for pregnancy-related assistance''.
            (3) Effective date.--
                    (A) In general.--Subject to subparagraph (B), the 
                amendments made by subsection (c) and this subsection 
                shall take effect on January 1, 2025.
                    (B) Delay permitted if state legislation 
                required.--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.
    (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)) is 
                        amended--
                                    (I) in subparagraph (II), by 
                                striking ``and'' at the end;
                                    (II) in subparagraph (JJ), by 
                                inserting ``and'' at the end; and
                                    (III) by adding at the end the 
                                following new subparagraph:
                    ``(KK) HIV prevention services (as defined in 
                subsection (nnn));''.
                            (ii) Definition.--Section 1861 of the 
                        Social Security Act (42 U.S.C. 1395x) is 
                        amended by adding at the end the following new 
                        subsection:
    ``(nnn) HIV Prevention Services.--The term `HIV prevention 
services' means--
            ``(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)) is 
                amended--
                            (i) by striking ``and (HH)'' and inserting 
                        ``(HH)''; and
                            (ii) 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)''.
                    (C) Exemption from part b deductible.--The first 
                sentence of section 1833(b) of the Social Security Act 
                (42 U.S.C. 1395l(b)) is amended--
                            (i) by striking ``, and (13)'' and 
                        inserting ``(13)''; and
                            (ii) 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)).''.
                    (D) Effective date.--The amendments made by this 
                paragraph shall apply to items and services furnished 
                on or after January 1, 2025.
            (2) Elimination of cost-sharing for drugs for the 
        prevention of hiv under part d.--
                    (A) In general.--Section 1860D-2 of the Social 
                Security Act (42 U.S.C. 1395w-102(b)) is amended--
                            (i) in subsection (b)--
                                    (I) in paragraph (1)(A), by 
                                striking ``and (9)'' and inserting ``, 
                                (9), and (10)'';
                                    (II) in paragraph (2)--
                                            (aa) in subparagraph (A), 
                                        by striking ``and (9)'' and 
                                        inserting ``, (9), and (10)'';
                                            (bb) in subparagraph 
                                        (C)(i), in the matter preceding 
                                        subclause (I), by striking 
                                        ``and (9)'' and inserting 
                                        ``(9), and (10)''; and
                                            (cc) in subparagraph 
                                        (D)(i), in the matter preceding 
                                        subclause (I), by striking 
                                        ``and (9)'' and inserting 
                                        ``(9), and (10)'';
                                    (III) in paragraph (3)(A), in the 
                                matter preceding clause (i), by 
                                striking ``and (9)'' and inserting 
                                ``(9), and (10)'';
                                    (IV) in paragraph (4)(A)(i), by 
                                striking ``and (9)'' and inserting ``, 
                                (9), and (10)''; and
                                    (V) by adding at the end the 
                                following new paragraph:
            ``(10) Elimination of cost-sharing for drugs for the 
        prevention of hiv.--For plan years beginning on or after 
        January 1, 2025, with 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
                            (ii) in subsection (c), by adding at the 
                        end the following new paragraph:
            ``(7) Treatment of cost-sharing for drugs for the 
        prevention of hiv.--The coverage is provided in accordance with 
        subsection (b)(10).''.
                    (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)(D), in each of clauses 
                        (ii) and (iii), by striking ``paragraph (6)'' 
                        and inserting ``paragraphs (6) and (7)'';
                            (ii) in paragraph (2)--
                                    (I) in subparagraph (B), by 
                                striking ``and (9)'' and inserting ``, 
                                (9), and (10)'';
                                    (II) in subparagraph (D), by 
                                striking ``paragraph (6)'' and 
                                inserting ``paragraphs (6) and (7)''; 
                                and
                                    (III) in subparagraph (E), by 
                                striking ``paragraph (6)'' and 
                                inserting ``paragraphs (6) and (7)''; 
                                and
                            (iii) by adding at the end the following 
                        new paragraph:
            ``(7) No application of cost-sharing or deductible for 
        drugs for the prevention of hiv.--For plan years beginning on 
        or after January 1, 2025, with 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.''.
    (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'' 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, 
                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 of title 10, United States 
        Code, is amended by inserting after section 1074o the following 
        new section:
``Sec. 1074p. 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 1074o the following new item:

``1074p. Coverage of HIV prevention treatment.''.
    (h) Indian Health Service Testing, Monitoring, and Prescription 
Drugs for the Prevention of HIV.--Title II of the Indian Health Care 
Improvement Act is amended by inserting after section 223 (25 U.S.C. 
1621v) the following:

``SEC. 224. TESTING, MONITORING, AND PRESCRIPTION DRUGS FOR THE 
              PREVENTION OF HIV.

    ``(a) In General.--The Secretary, acting through the Director of 
HIV/AIDS Prevention and Treatment under section 832, 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.
    ``(b) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as are 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, 2025.

SEC. 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 an individual 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).

SEC. 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:

``SEC. 399V-8. 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, the 
        Administrator 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-9--
            ``(1) the term `PEP' means any drug or combination of drugs 
        approved by the Food and Drug Administration for preventing HIV 
        transmission after a sexual or other exposure associated with a 
        high risk of HIV transmission; and
            ``(2) the term `PrEP' means any drug approved by the Food 
        and Drug Administration for the purpose of pre-exposure 
        prophylaxis with respect to HIV.
    ``(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 2024 through 2029.''.

SEC. 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.

SEC. 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.), as amended by section 5, is further amended by adding at 
the end the following:

``SEC. 399V-9. PRE-EXPOSURE PROPHYLAXIS AND POST-EXPOSURE PROPHYLAXIS 
              FUNDING.

    ``(a) In General.--Not later than 1 year after the date of the 
enactment of the PrEP Access and Coverage Act, 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') programs.
    ``(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);
                    ``(B) a family planning grantee (other than States) 
                funded under section 1001;
                    ``(C) a rural health clinic (as defined in section 
                1861(aa)(2) of the Social Security Act);
                    ``(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;
                    ``(C) outreach activities directed toward 
                physicians and other providers that provide education 
                about PrEP and PEP; and
                    ``(D) adherence services and counseling, including 
                personnel costs for PrEP navigators to retain patients 
                in care.
    ``(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 of 2023, 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, Indian Tribes, and directly eligible entities for the 
establishment and support of pre-exposure prophylaxis programs under 
this section.
    ``(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 2024 through 2029.''.

SEC. 8. CLARIFICATION.

    This Act, including the amendments made by this Act, shall apply 
notwithstanding any other provision of law, including Public Law 103-
141.

SEC. 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.

SEC. 10. ENFORCEMENT.

    (a) In General.--The Secretary of Health and Human Services, in 
consultation with the Centers for Disease Control and Prevention, 
shall--
            (1) issue guidance regarding the implementation of the 
        coverage requirements established under this Act, including the 
        amendments made by this Act, including with respect to 
        implementation of such coverage requirements;
            (2) develop and disseminate educational materials, 
        including billing and coding documents;
            (3) provide technical assistance to State insurance 
        commissioners;
            (4) provide technical assistance to eligible entities for 
        regarding responding to consumer complaints and assisting in 
        resolving such complaints; and
            (5) work with other Federal agencies to assist in 
        enforcement and compliance.
    (b) Compliance.--
            (1) In general.--The Secretary of Health and Human 
        Services, the Secretary of Labor, and the Secretary of the 
        Treasury, in consultation with the Director of the Centers for 
        Disease Control and Prevention, shall monitor compliance by 
        group health plans and health insurance issuers with coverage 
        requirements established under title XXVII of the Public Health 
        Service Act (42 U.S.C. 300gg et seq.), as amended by section 3) 
        and shall take appropriate enforcement actions under the Public 
        Health Service Act, the Employee Retirement Income Security Act 
        of 1974, and the Internal Revenue Code of 1986.
            (2) Insurer submissions to the secretary.--Beginning not 
        later than 1 year after the date of enactment of this Act, each 
        group health plan and health insurance issuer offering group or 
        individual health insurance coverage shall submit to the 
        Secretary of Health and Human Services, at such time as such 
        secretary, in coordination with the Secretary of Labor and the 
        Secretary of the Treasury, shall require, but not less 
        frequently than annually for the 10-year period beginning on 
        such date of enactment, data demonstrating compliance with the 
        coverage requirements described in paragraph (1), including 
        aggregate data on the number of claims received by such plans 
        and issuers for HIV prevention services and the cost-sharing 
        for enrollees with respect to such claims.
            (3) Reports to congress.--Not later than 2 years after the 
        enactment of this Act and every 2 years thereafter for the 10-
        year period beginning on such date of enactment, the Secretary 
        of Health and Human Services, the Secretary of Labor, and the 
        Secretary of the Treasury (collectively referred to in this 
        section as the ``Secretaries'') shall jointly submit to 
        Congress and make publicly available a report to assess the 
        prevalence of noncompliance with the coverage requirements 
        described in paragraph (1). Each such report shall include--
                    (A) aggregate information about group health plans 
                and health insurance issuers that the Secretaries 
                determine to be out of compliance with such 
                requirements; and
                    (B) steps the Secretaries have taken to address 
                incidences of such noncompliance.
            (4) Definitions.--In this subsection, the terms ``group 
        health plan'', ``health insurance coverage'', and ``health 
        insurance issuer'' have the meanings given such terms in 
        section 2729 of the Public Health Service Act (42 U.S.C. 300gg-
        91).
                                 <all>