PrEP Access and Coverage Act
This bill requires private health insurance plans to cover prescription drugs that prevent HIV, including related screenings, diagnostic procedures, administrative fees, and 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 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 an individual 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 and underinsured 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 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6117 Introduced in House (IH)]
<DOC>
117th CONGRESS
1st Session
H. R. 6117
To increase access to pre-exposure prophylaxis to reduce the
transmission of HIV.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 1, 2021
Mr. Schiff (for himself, Mr. Nadler, Ms. Titus, Mr. Cohen, Ms. Lee of
California, Ms. Porter, Ms. Speier, Mr. Pocan, Mrs. Watson Coleman, Mr.
Welch, Mr. Tonko, Mr. Casten, Mr. Takano, Mr. Rush, Ms. Sewell, Mr.
Khanna, Ms. Pressley, Mr. Quigley, Mr. Moulton, Mr. Soto, Ms. Manning,
Ms. Pingree, Mr. Payne, Ms. Jackson Lee, Mr. Lynch, Mr. Cicilline, Mr.
Torres of New York, Ms. Velazquez, Mr. Jones, Ms. Tlaib, Mr. Swalwell,
Ms. Norton, and Mr. Blumenauer) introduced the following bill; which
was referred to the Committee on Energy and Commerce, and in addition
to the Committees on Oversight and Reform, Ways and Means, Veterans'
Affairs, Armed Services, Natural Resources, 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; 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
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>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Oversight and Reform, Ways and Means, Veterans' Affairs, Armed Services, Natural Resources, 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.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Oversight and Reform, Ways and Means, Veterans' Affairs, Armed Services, Natural Resources, 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.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Oversight and Reform, Ways and Means, Veterans' Affairs, Armed Services, Natural Resources, 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.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Oversight and Reform, Ways and Means, Veterans' Affairs, Armed Services, Natural Resources, 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.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Oversight and Reform, Ways and Means, Veterans' Affairs, Armed Services, Natural Resources, 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.
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Referred to the Committee on Energy and Commerce, and in addition to the Committees on Oversight and Reform, Ways and Means, Veterans' Affairs, Armed Services, Natural Resources, 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.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Oversight and Reform, Ways and Means, Veterans' Affairs, Armed Services, Natural Resources, 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.
Referred to the Subcommittee on Health.
Referred to the Subcommittee for Indigenous Peoples of the United States.
Referred to the Subcommittee on Health.