[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2188 Introduced in Senate (IS)]
<DOC>
118th CONGRESS
1st Session
S. 2188
To increase access to pre-exposure prophylaxis to reduce the
transmission of HIV.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 22, 2023
Ms. Smith 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 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 (9) and (10) 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 and 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 of 2023, 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
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).
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