[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 3295 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  1st Session
                                S. 3295

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            December 1, 2021

  Ms. Smith (for herself and Ms. Klobuchar) 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.

    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''.

SEC. 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'') is a daily antiretroviral medication that helps 
        prevent individuals from acquiring HIV. Daily PrEP use reduces 
        the risk of getting HIV from sex by about 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 1,100,000 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) 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 have to cover PrEP for such 
        individuals without cost-sharing effective January 2021.
            (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'') is a daily antiretroviral treatment which, when 
        initiated promptly after a sexual or other exposure to blood or 
        body fluids that is associated with a high risk of HIV 
        transmission, is highly effective at preventing HIV infection.
            (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).

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:
                            ``(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)) 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) is amended--
                    (A) in subsection (a), by striking ``and (8)'' and 
                inserting ``(8), (10), (11), and (12)''; and
                    (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)) is amended by inserting 
        ``HIV prevention services described in subsection (c)(12),'' 
        before ``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)) is 
                        amended--
                                    (I) in subparagraph (GG), by 
                                striking ``and'' at the end;
                                    (II) in subparagraph (HH), by 
                                striking the period at the end and 
                                inserting ``; and''; 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) is 
                        amended by adding at the end the following new 
                        subsection:
    ``(lll) 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 (DD)'' and inserting 
                        ``(DD)''; and
                            (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)) 
                is amended--
                            (i) in paragraph (11), by striking ``and'' 
                        at the end; 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)) 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) 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)) 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.''.
            (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 1079c the following 
        new section:
``Sec. 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) the 
following:

``SEC. 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'), 
administrative fees for such a drug, laboratory and other diagnostic 
procedures associated with the use of such a drug, 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 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.

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 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).

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-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' means any drug or combination of drugs 
        approved by the Food and Drug Administration for preventing HIV 
        infection 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 2023 through 2028.''.

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-8. 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 (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, 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 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 2023 through 2028.''.

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.
                                 <all>