This Act may be cited as the “PrEP Access and Coverage Act”.

(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).

(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:

(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:

(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:

(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.

(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).

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:

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.

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:

This Act, including the amendments made by this Act, shall apply notwithstanding any other provision of law, including Public Law 103–141.

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.