S. 3990

119 S3990 IS: PrEP Access and Coverage Act of 2026
 U.S. Senate
 2026-03-04
 text/xml
 EN
 Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
 II  119th CONGRESS  2d Session  S. 3990  IN THE SENATE OF THE UNITED STATES   March 4, 2026   Ms. Smith  (for herself,  Mr. Schiff ,  Ms. Alsobrooks ,  Ms. Baldwin ,  Mr. Blumenthal ,  Mr. Booker ,  Mr. Coons ,  Ms. Cortez Masto ,  Ms. Duckworth ,  Mr. Kim ,  Ms. Klobuchar ,  Mr. Markey ,  Mr. Merkley ,  Mr. Padilla ,  Mr. Reed ,  Ms. Rosen ,  Mrs. Shaheen ,  Ms. Warren ,  Mr. Wyden , and  Mr. Hickenlooper ) 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.
1.
Short title
This Act may be cited as the   PrEP Access and Coverage Act of 2026  .
2.
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 this Act.
3.
Coverage requirements
(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  ; and ;
(D)
by striking paragraph (5);
(E)
by adding at the end the following:
(5)
any prescription drug approved by the Food and Drug Administration used for the prevention of HIV (other than a drug subject to preauthorization requirements consistent with section 2729A–11), 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, including policy notes updating those guidelines, without limitation.
 ; and
(F)
by adding at the end of the flush text at the end the following:  For the purposes of this Act, and for the purposes of any other provision of law, the current recommendations of the United States Preventive Service Task Force regarding breast cancer screening, mammography, and prevention shall be considered the most current other than those issued in or around November 2009. .
(2)
Grandfathered plans
Section 1251(a)(4) of the Patient Protection and Affordable Care Act ( 42 U.S.C. 18011(a)(4) ) is amended by adding at the end the following:
(v)
Section 2713(a)(5) (relating to coverage without cost-sharing for prescription drugs for the prevention of HIV).
 .
(3)
Prohibition on preauthorization requirements
(A)
PHSA
Part D of title XXVII of the Public Health Service Act ( 42 U.S.C. 300gg–111 et seq. ) is amended by adding at the end the following:
2799A–12.
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)(5), 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)
ERISA
(i)
In general
Subpart B of part 7 of subtitle B of title I of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1185 et seq. ) is amended by adding at the end the following:
727.
Prohibition on preauthorization requirements with respect to certain services
A group health plan or a health insurance issuer offering group health insurance coverage shall not impose any preauthorization requirements with respect to coverage of the services described in section 2713(a)(5) of the Public Health Service Act, 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 the Public Health Service Act if such plan or issuer provides coverage without any preauthorization requirements for a drug that is therapeutically equivalent.
 .
(ii)
Clerical amendment
The table of contents in section 1 of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1001 et seq. ) is amended by inserting after the item relating to section 726 the following new item:
Sec. 727. Prohibition on preauthorization requirements with respect to certain services.
  .
(C)
IRC
(i)
In general
 Chapter 100  of the Internal Revenue Code of 1986 is amended by adding at the end of subchapter B the following:
9827.
Prohibition on preauthorization requirements with respect to certain services
A group health plan shall not impose any preauthorization requirements with respect to coverage of the services described in section 2713(a)(5) of the Public Health Service Act, except that a plan 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 the Public Health Service Act if such plan provides coverage without any preauthorization requirements for a drug that is therapeutically equivalent.
 .
(ii)
Clerical amendment
The table of sections for subchapter B of  chapter 100  of the Internal Revenue Code of 1986 is amended by adding at the end the following new item:
 Sec. 9827. Prohibition on preauthorization requirements with respect to certain services. .
(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 used 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, including policy notes updating those guidelines, without limitation.
 .
(c)
Medicaid
(1)
In general
Section 1905 of the Social Security Act ( 42 U.S.C. 1396d ) is amended by—
(A)
in subsection (a)(4), 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:
(ll)
HIV prevention services
For purposes of subsection (a)(4)(G), the term  HIV prevention services  means all prescription drugs used 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, including policy notes updating those 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 heading, 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), in the matter preceding paragraph (1), by striking  and (8)  and inserting  (8), 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(ll)).
 .
(2)
No cost-sharing
Section 2103(e)(2) of the Social Security Act ( 42 U.S.C. 1397cc(e)(2) ) is amended—
(A)
in the paragraph heading, by inserting
HIV prevention services,   after
treatment,  ; and
(B)
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, 2027.
(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 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 (JJ), by striking  and  at the end;
(II)
in subparagraph (KK), by inserting  and  at the end; and
(III)
by adding at the end the following new subparagraph:
(LL)
HIV prevention services (as defined in subsection (ooo));
  .
(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:
(ooo)
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, including policy notes updating those 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(ooo)), 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(ooo)(1)). .
(D)
Effective date
The amendments made by this paragraph shall apply to items and services furnished on or after January 1, 2027.
(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 ) 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, 2027, 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, 2027, 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 and used for the prevention of HIV, administrative fees for such a drug, or clinical follow-up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines, including policy notes updating those 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 and used for the prevention of 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, including policy notes updating those 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 and used for the prevention of 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, including policy notes updating those 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:
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 and used for the prevention of 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, including policy notes updating those 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:
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, 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 Public Health Service clinical practice guidelines, including policy notes updating those 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, 2027.
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).
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:
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 from communities that are disproportionately affected by 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 2026 through 2030.
 .
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)(5) 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.
7.
PrEP and PEP 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:
399V–9.
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 of 2026 , 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 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 used 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, including policy notes updating those 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 1 year after the date of enactment of the  PrEP Access and Coverage Act of 2026 , submit to Congress, and make public on the 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 2026 through 2030.
 .
8.
Clarification
This Act, including the amendments made by this Act, shall apply notwithstanding any other provision of law, including  Public Law 103–141 .
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.
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 based on stakeholder consensus-driven recommendations, as appropriate;
(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 sections 2799A–11 of the Public Health Service Act, 726 of the Employee Retirement Income Security Act of 1974, and 9826 of the Internal Revenue Code of 1986 (as added by section 3(a)) and shall take appropriate enforcement actions under such Acts and such Code.
(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 date of 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 2791 of the Public Health Service Act ( 42 U.S.C. 300gg–91 ).