Title: PrEP Access and Coverage Act
Policy area: Health

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

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3815 Introduced in House (IH)]

<DOC>






116th CONGRESS
  1st Session
                                H. R. 3815

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 17, 2019

 Mr. Schiff (for himself, Mrs. Watson Coleman, Ms. Lee of California, 
Mr. Khanna, Ms. Mucarsel-Powell, Mr. Rush, Mr. Crist, Ms. Barragan, Ms. 
Haaland, Mr. Pappas, Mr. Moulton, Mr. Cox of California, Mr. Cohen, and 
Ms. Pressley) introduced the following bill; which was referred to the 
Committee on Energy and Commerce, and in addition to the Committees on 
   Oversight and Reform, Veterans' Affairs, Ways and Means, Natural 
 Resources, Armed Services, and Financial Services, 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''.

SEC. 2. FINDINGS.

    Congress finds as follows:
            (1) The Centers for Disease Control and Prevention 
        estimates that approximately 1,100,000 people in the United 
        States are living with HIV.
            (2) In 2017, there were 38,281 new diagnoses of HIV in the 
        United States.
            (3) HIV disproportionately impacts gay and bisexual men, 
        transgender women, and, in particular, people of color. For 
        example, in 2017 approximately 66 percent of new HIV diagnoses 
        were among gay and bisexual men, 43 percent of new HIV 
        diagnoses were among Black people, and 26 percent of new HIV 
        diagnoses were among Latinx people. Recent studies suggest that 
        transgender women are up to 49 times more likely to be 
        diagnosed with HIV than the general population. Members of 
        communities at the intersections of these groups are most 
        heavily impacted.
            (4) Pre-exposure prophylaxis (referred to in this section 
        as ``PrEP'') is a daily antiretroviral medication that helps 
        prevent individuals from acquiring HIV. Daily PrEP use reduces 
        the risk of getting HIV from sex by over 90 percent. It reduces 
        the risk of getting HIV from injection drug use by over 70 
        percent.
            (5) Many individuals at risk of exposure to HIV do not use 
        PrEP. Of the approximately 1,100,000 people in the United 
        States who could benefit from PrEP, only 7 percent, or 78,360 
        individuals, filled prescriptions for the drug in 2016.
            (6) PrEP usage is inconsistent across racial and gender 
        lines. In 2016, PrEP users were 68.7 percent White, 11.2 
        percent Black, and 13.1 percent Latinx. However, individuals 
        eligible for PrEP were 26.3 percent White, 43.7 percent Black, 
        and 24.7 percent Latinx. Additionally, only 2.1 percent of 
        women eligible for PrEP received a prescription in 2016.
            (7) There is currently only one version of PrEP approved by 
        the Food and Drug Administration, marketed under the brand name 
        of Truvada, which, in 2018, had a list price of over $20,000 a 
        year in the United States. A less expensive, generic version of 
        PrEP is expected to be available in September 2020, and other 
        types of HIV prevention treatments, including oral pills, 
        vaginal rings, and long-acting injectables, are currently in 
        the research pipeline.
            (8) Section 2713 of the Public Health Service Act (42 
        U.S.C. 300gg-13) requires most private health insurance plans 
        to cover preventive services without cost sharing, including 
        such services with a rating of ``A'' or ``B'' under 
        recommendations of the United States Preventive Services Task 
        Force. On June 11, 2019, the United States Preventive Services 
        Task Force issued a final recommendation giving an ``A'' grade 
        for PrEP for individuals at high risk of HIV; non-grandfathered 
        private health insurance plans will have to cover PrEP for such 
        individuals without cost sharing by 2021.
            (9) Despite such recommendation of the United States 
        Preventive Services Task Force, access barriers to PrEP remain. 
        Ancillary services necessary to maintain the PrEP regime, 
        including subsequent provider visits, clinical testing, and 
        other services, can remain a cost-burden on patients. 
        Additionally, the new recommendations are not linked to 
        coverage requirements for individuals with other types of 
        insurance, such as Medicare or Medicaid.
            (10) Expanding access to cost-free PrEP and ancillary 
        services for all individuals, including individuals who do not 
        have health insurance, is a critical step towards eliminating 
        HIV transmission.

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 acquisition, 
        laboratory and other diagnostic procedures associated with the 
        use of such drugs, and clinical follow up and monitoring, 
        including any related services recommended in current United 
        States Public Health Service clinical practice guidelines, 
        without limitation.''.
            (2) Prohibition on preauthorization requirements.--Subpart 
        II of part A of title XXVII of the Public Health Service Act 
        (42 U.S.C. 300gg-11 et seq.) is amended by adding at the end 
        the following:

``SEC. 2729. PROHIBITION ON PREAUTHORIZATION REQUIREMENTS WITH RESPECT 
              TO CERTAIN SERVICES.

    ``A group health plan or a health insurance issuer offering group 
or individual health insurance coverage shall not impose any pre-
authorization requirements with respect to coverage of the services 
described in section 2713(a)(6).''.
    (b) Coverage Under Federal Employees Health Benefits Program.--
Section 8904 of title 5, United States Code, is amended by adding at 
the end the following:
    ``(c) Any health benefits plan offered under this chapter shall 
include benefits for, and may not impose any cost sharing requirements 
for, any prescription drug approved by the Food and Drug Administration 
for the prevention of HIV acquisition, laboratory and other diagnostic 
procedures associated with the use of such drugs, and clinical follow 
up and monitoring, including any related services recommended in 
current United States Public Health Service clinical practice 
guidelines, without limitation.''.
    (c) Medicaid.--
            (1) In general.--Section 1905 of the Social Security Act 
        (42 U.S.C. 1396d) is amended--
                    (A) in subsection (a)(4)--
                            (i) by striking ``and (D)'' and inserting 
                        ``(D)''; and
                            (ii) by inserting ``; and (E) HIV 
                        prevention services'' before the semicolon; and
                    (B) by adding at the end the following new 
                subsection:
    ``(ff) HIV Prevention Services.--For purposes of subsection 
(a)(4)(E), the term `HIV prevention services' means prescription drugs 
for the prevention of HIV acquisition, laboratory and other diagnostic 
procedures associated with the use of such drugs, and clinical follow 
up and monitoring, including any related services recommended in 
current United States Public Health Service clinical practice 
guidelines, without limitation.''.
            (2) No cost sharing.--Title XIX of the Social Security Act 
        (42 U.S.C. 1396 et seq.) is amended--
                    (A) in section 1916, by inserting ``HIV prevention 
                services described in section 1905(a)(4)(E),'' after 
                ``section 1905(a)(4)(C),'' each place it appears; and
                    (B) in section 1916A(b)(3)(B), by adding at the end 
                the following new clause:
                            ``(xi) HIV prevention services described in 
                        section 1905(a)(4)(E).''.
            (3) Inclusion in benchmark coverage.--Section 1937(b)(7) of 
        the Social Security Act (42 U.S.C. 1396u-7(b)(7)) is amended--
                    (A) in the paragraph header, by inserting ``and hiv 
                prevention services'' after ``supplies''; and
                    (B) by inserting ``, and, for any individual 
                described in section 1905(a)(4)(E), medical assistance 
                for HIV prevention services in accordance with such 
                section'' before the period.
    (d) CHIP.--
            (1) In general.--Section 2103(c) of the Social Security Act 
        (42 U.S.C. 1397cc(c)), as amended by section 5022 of the 
        SUPPORT for Patients and Communities Act (Public Law 115-271), 
        is amended by adding at the end the following new paragraph:
            ``(10) HIV prevention services.--The child health 
        assistance provided to a targeted low-income child and the 
        pregnancy-related assistance provided to a targeted low-income 
        woman shall include coverage of HIV prevention services (as 
        defined in section 1905(ff)).''.
            (2) No cost sharing.--Section 2103(e)(2) of the Social 
        Security Act (42 U.S.C. 1397cc(e)(2)) is amended by inserting 
        ``, for HIV prevention services described in subsection 
        (c)(10),'' after ``subsection (c)(1)(D)''.
            (3) Conforming amendment.--Section 2103(a) of the Social 
        Security Act (42 U.S.C. 1397cc(a)), as amended by section 5022 
        of the SUPPORT for Patients and Communities Act (Public Law 
        115-271), is amended in the matter preceding paragraph (1) by 
        striking ``and (8)'' and inserting ``(8), and (10)''.
            (4) Effective date.--
                    (A) In general.--Subject to subparagraph (A), the 
                amendments made by subsection (c) and this subsection 
                shall take effect on January 1, 2021.
                    (B) Delay permitted if state legislation 
                required.--In the case of a State plan approved under 
                title XIX of the Social Security Act which the 
                Secretary of Health and Human Services determines 
                requires State legislation (other than legislation 
                appropriating funds) in order for the plan to meet the 
                additional requirements imposed by this section, the 
                State plan shall not be regarded as failing to comply 
                with the requirements of such title solely on the basis 
                of the failure of the plan to meet such additional 
                requirements before the 1st day of the 1st calendar 
                quarter beginning after the close of the 1st regular 
                session of the State legislature that ends after the 1-
                year period beginning with the date of the enactment of 
                this section. For purposes of the preceding sentence, 
                in the case of a State that has a 2-year legislative 
                session, each year of the session is deemed to be a 
                separate regular session of the State legislature.
    (e) Waiver of Cost Sharing Under Medicare.--
            (1) Part b.--
                    (A) Inclusion as a preventive service.--Section 
                1861(ddd)(3) of the Social Security Act (42 U.S.C. 
                1395x(ddd)(3)) is amended by adding at the end the 
                following new subparagraph:
                    ``(D) Drugs or biologicals approved by the Food and 
                Drug Administration for the prevention of HIV 
                acquisition, laboratory and other diagnostic procedures 
                associated with the use of such drugs, and clinical 
                follow up and monitoring, including any related 
                services recommended in current United States Public 
                Health Service clinical practice guidelines, without 
                limitation.''.
                    (B) Elimination of coinsurance.--Section 1833(a)(1) 
                of the Social Security Act (42 U.S.C. 1395l(a)(1)) is 
                amended--
                            (i) by striking ``and (CC)'' and inserting 
                        ``(CC)''; and
                            (ii) by inserting before the semicolon at 
                        the end the following:`` , and (DD) with 
                        respect to preventive services described in 
                        subparagraph (D) of section 1861(ddd)(3), the 
                        amount paid shall be 100 percent of (i) except 
                        as provided in clause (ii), the lesser of the 
                        actual charge for the service or the amount 
                        determined under the fee schedule that applies 
                        to such treatment under this part, and (ii) in 
                        the case of such services that are covered OPD 
                        services (as defined in subsection (t)(1)(B)), 
                        the amount determined under subsection (t)''.
                    (C) Exemption from part b deductible.--Section 
                1833(b) of the Social Security Act (42 U.S.C. 1395l(b)) 
                is amended--
                            (i) in paragraph (9), by striking ``and'' 
                        at the end; and
                            (ii) in paragraph (10), by striking the 
                        period at the end and inserting ``, and (11) 
                        such deductible shall not apply with respect to 
                        preventive services described in subparagraph 
                        (D) of section 1861(ddd)(3).''.
                    (D) Effective date.--The amendments made by this 
                paragraph shall apply to items and services furnished 
                on or after January 1, 2021.
            (2) Part d.--
                    (A) In general.--Section 1860D-2(b) of the Social 
                Security Act (42 U.S.C. 1395w-102(b)) is amended--
                            (i) in paragraph (1)(A), by striking ``The 
                        coverage'' and inserting ``Subject to paragraph 
                        (8), the coverage'';
                            (ii) in paragraph (2)(A), by striking ``and 
                        (D)'' and inserting ``and (D) and paragraph 
                        (8)'';
                            (iii) in paragraph (3)(A), by striking 
                        ``and (4)'' and inserting ``(4), and (8)'';
                            (iv) in paragraph (4)(A)(i), by striking 
                        ``The coverage'' and inserting ``Subject to 
                        paragraph (8), the coverage''; and
                            (v) by adding at the end the following new 
                        paragraph:
            ``(8) Limitations on cost-sharing for drugs for the 
        prevention of hiv acquisition.--
                    ``(A) In general.--For plan year 2021 and each 
                subsequent plan year, there shall be no cost-sharing 
                under this part (including under section 1814D-14) for 
                covered part D drugs that are for the prevention of HIV 
                acquisition.
                    ``(B) Cost-sharing.--For purposes of subparagraph 
                (A), the elimination of cost-sharing shall include the 
                following:
                            ``(i) No application of deductible.--The 
                        waiver of the deductible under paragraph (1).
                            ``(ii) No application of coinsurance.--
                        There waiver of coinsurance under paragraph 
                        (2).
                            ``(iii) No application of initial coverage 
                        limit.--The initial coverage limit under 
                        paragraph (3) shall not apply.
                            ``(iv) No cost sharing above annual out-of-
                        pocket threshold.--The waiver of cost sharing 
                        under paragraph (4).''.
                    (B) Conforming amendments to cost sharing for low-
                income individuals.--Section 1860D-14(a) of the Social 
                Security Act (42 U.S.C. 1395w-114(a)) is amended--
                            (i) in paragraph (1), in the matter 
                        preceding subparagraph (A), by striking ``In 
                        the case'' and inserting ``Subject to section 
                        1860D-2(b)(8), in the case''; and
                            (ii) in paragraph (2), in the matter 
                        preceding subparagraph (A), by striking ``In 
                        the case'' and inserting ``Subject to section 
                        1860D-2(b)(8), in the case''.
    (f) Coverage of HIV Prevention Treatment by Department of Veterans 
Affairs.--
            (1) Elimination of medication copayments.--Section 1722A(a) 
        of title 38, United States Code, is amended by adding at the 
        end the following new paragraph:
    ``(5) Paragraph (1) does not apply to a medication for the 
prevention of HIV acquisition.''.
            (2) Elimination of hospital care and medical services 
        copayments.--Section 1710 of such title is amended--
                    (A) in subsection (f)--
                            (i) by redesignating paragraph (5) as 
                        paragraph (6); and
                            (ii) by inserting after paragraph (4) the 
                        following new paragraph (5):
    ``(5) A veteran shall not be liable to the United States under this 
subsection for any amounts for laboratory and other diagnostic 
procedures associated with the use of any prescription drug approved by 
the Food and Drug Administration for the prevention of HIV acquisition, 
or for laboratory or other diagnostic procedures associated with the 
use of such drugs, or clinical follow up and monitoring, including any 
related services recommended in current United States Public Health 
Service clinical practice guidelines, without limitation.''; and
                    (B) in subsection (g)(3), by adding at the end the 
                following new subparagraph:
            ``(C) Any prescription drug approved by the Food and Drug 
        Administration for the prevention of HIV acquisition, 
        laboratory and other diagnostic procedures associated with the 
        use of such drugs, and clinical follow up and monitoring, 
        including any related services recommended in current United 
        States Public Health Service clinical practice guidelines, 
        without limitation.''.
            (3) Inclusion as preventive health service.--Section 
        1701(9) of such title is amended--
                    (A) in subparagraph (K), by striking ``; and'' and 
                inserting a semicolon;
                    (B) by redesignating subparagraph (L) as 
                subparagraph (M); and
                    (C) by inserting after subparagraph (K) the 
                following new subparagraph (L):
                    ``(L) any prescription drug approved by the Food 
                and Drug Administration for the prevention of HIV 
                acquisition, laboratory and other diagnostic procedures 
                associated with the use of such drugs, and clinical 
                follow up and monitoring, including any related 
                services recommended in current United States Public 
                Health Service clinical practice guidelines, without 
                limitation; and''.
    (g) Coverage of HIV Prevention Treatment by Department of 
Defense.--
            (1) In general.--Chapter 55 of title 10, United States 
        Code, is amended by inserting after section 1079c the following 
        new section:
``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 acquisition, 
laboratory and other diagnostic procedures associated with the use of 
such drugs, and clinical follow up and monitoring, including any 
related services recommended in current United States Public Health 
Service clinical practice guidelines, without limitation.
    ``(c) No Cost-Sharing.--Notwithstanding section 1075, 1075a, or 
1074g(a)(6) of this title or any other provision of law, there is no 
cost-sharing requirement for HIV prevention treatment covered under 
this section.''.
            (2) Clerical amendment.--The table of sections at the 
        beginning of such chapter is amended by inserting after the 
        item relating to section 1079c the following new item:

``1079d. Coverage of HIV prevention treatment.''.
    (h) Indian Health Service Testing, Monitoring, and Prescription 
Drugs for the Prevention of HIV Acquisition.--The Indian Health Care 
Improvement Act is amended by inserting after section 223 (25 U.S.C. 
1621v) the following:

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

    ``(a) In General.--The Secretary, acting through the Service, 
Indian tribes, and tribal organizations, shall provide funding for any 
prescription drug approved by the Food and Drug Administration for the 
prevention of HIV acquisition, laboratory and other diagnostic 
procedures associated with the use of such drugs, and clinical follow 
up and monitoring, including any related services recommended in 
current United States Public Health Service clinical practice 
guidelines, without limitation.
    ``(b) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section such sums as may be 
necessary.''.
    (i) Effective Date.--The amendments made by subsections (a), (b), 
(e), (f), (g), and (h) shall take effect with respect to plan years 
beginning on or after January 1, 2021.

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 PUBLIC EDUCATION CAMPAIGN.

    ``(a) In General.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention, shall establish a 
public health campaign for the purpose of educating the public on 
medication for the prevention of HIV acquisition.
    ``(b) Requirements.--In carrying out this section, the Secretary 
shall ensure cultural competency and efficacy within high-need 
communities in which PrEP is underutilized by developing the campaign 
in collaboration with organizations that are indigenous to communities 
that are overrepresented in the domestic HIV epidemic, including 
communities of color and the lesbian, gay, bisexual, transgender, and 
queer community. The Secretary shall ensure that the campaign is 
designed to increase awareness of the safety and effectiveness of PrEP, 
the recommended clinical practices for providing PrEP-related clinical 
care, and the local availability of PrEP providers, and to counter 
stigma associated with the use of PrEP.
    ``(c) Evaluation of Program.--The Secretary shall develop measures 
to evaluate the effectiveness of activities conducted under this 
section that are aimed at reducing disparities in access to PrEP and 
supporting the local community. Such measures shall evaluate community 
outreach activities, language services, workforce cultural competence, 
and other areas as determined by the Secretary.
    ``(d) PrEP.--In this section, the term `PrEP' means any drug 
approved by the Food and Drug Administration for the purpose of pre-
exposure prophylaxis with respect to HIV.
    ``(e) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary for each of fiscal years 
2021 through 2026.''.

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 FUNDING.

    (a) In General.--Not later than 1 year after the date of enactment 
of this Act, the Secretary of Health and Human Services (in this Act 
referred to as the ``Secretary'') shall establish a program that 
provides grants to States, territories, and Indian Tribes for the 
establishment and support of pre-exposure prophylaxis (referred to in 
this section as ``PrEP'') programs, or establishes a program for 
providing Federal funding directly to eligible entities within a State, 
territory, or Indian Tribal territory, in the case of a State, 
territory, or Indian Tribe that does not apply for such a grant.
    (b) Grant Program.--
            (1) Applications.--To be eligible to receive a grant under 
        subsection (a), a State, territory, or Indian Tribe shall--
                    (A) submit an application to the Secretary at such 
                time, in such manner, and containing such information 
                as the Secretary may require, including a description 
                of how any funds awarded will be used and a plan 
                describing how any funds awarded will be used to 
                increase access to PrEP for uninsured individuals and 
                reduce disparities in access to PrEP; and
                    (B) appoint a PrEP grant administrator to manage 
                the program.
            (2) Use of funds.--Any State, Territory of the United 
        States, or Indian tribe that is awarded funds under subsection 
        (a) shall use such funds for eligible PrEP expenses.
    (c) Federal Program.--
            (1) In general.--In the case of a State, territory, or 
        Indian Tribe that does not submit an application under 
        subsection (b), the Secretary shall provide funding to any of 
        the following, within the applicable State, territory, or 
        Indian Tribal territory:
                    (A) Federally qualified health centers (as defined 
                in section 1861(aa)(4) of the Social Security Act (42 
                U.S.C. 1395x(aa)(4))).
                    (B) Family planning grantees (other than States) 
                funded under section 1001 of the Public Health Service 
                Act (42 U.S.C. 300).
                    (C) Rural health clinics (as defined in section 
                1861(aa)(2) of the Social Security Act (42 U.S.C. 
                1395x(aa)(2))).
                    (D) Health facilities operated by or pursuant to a 
                contract with the Indian Health Service.
                    (E) Community-based organizations, clinics, 
                hospitals, and other health facilities that provide 
                services to individuals at risk for or living with HIV.
                    (F) Nonprofit private entities providing 
                comprehensive primary care to populations at risk of 
                HIV, including faith-based and community-based 
                organizations.
            (2) Use of funds.--Any entity receiving funding under 
        paragraph (1) shall use such funds for eligible PrEP expenses.
    (d) Eligible PrEP Expenses.--
            (1) In general.--The Secretary shall publish a list of 
        expenses that qualify as eligible PrEP expenses for purposes of 
        this section.
            (2) Inclusions.--Such list shall include--
                    (A) any prescription drug approved by the Food and 
                Drug Administration for the prevention of HIV 
                acquisition, laboratory and other diagnostic procedures 
                associated with the use of such drugs, and clinical 
                follow up and monitoring, including any related 
                services recommended in current United States Public 
                Health Service clinical practice guidelines, without 
                limitation;
                    (B) outreach and public education activities 
                directed toward populations overrepresented in the 
                domestic HIV epidemic that increase awareness about the 
                existence of PrEP, provide education about access to 
                and health care coverage of PrEP, and counter stigma 
                associated with the use of PrEP; and
                    (C) outreach activities directed toward physicians 
                and other providers that provide education about PrEP.
    (e) Report to Congress.--The Secretary shall, in each of the first 
5 years beginning one year after the date of the enactment of this Act, 
submit to Congress, and make public on the internet website of 
Department of Health and Human Services, a report on the impact of any 
grants provided to States, territories, and Indian Tribes for the 
establishment and support of pre-exposure prophylaxis programs under 
this section.
    (f) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $60,000,000 for each of the 
first 5 fiscal years beginning after the date of the enactment of this 
section.

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.
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