II 

116TH CONGRESS 

1ST SESSION S. 1926 

To increase access to pre-exposure prophylaxis to reduce the transmission 

of HIV. 

IN THE SENATE OF THE UNITED STATES 

JUNE 20, 2019 

Ms. HARRIS 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 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘PrEP Access and Cov5 erage Act’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds as follows: 

8 (1) The Centers for Disease Control and Pre9 vention estimates that approximately 1,100,000 peo10 ple in the United States are living with HIV. 


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1 (2) In 2017, there were 38,281 new diagnoses 

2 of HIV in the United States. 

3 (3) HIV disproportionately impacts gay and bi4 sexual men, transgender women, and, in particular, 

5 people of color. For example, in 2017 approximately 

6 66 percent of new HIV diagnoses were among gay 

7 and bisexual men, 43 percent of new HIV diagnoses 

8 were among Black people, and 26 percent of new 

9 HIV diagnoses were among Latinx people. Recent 

10 studies suggest that transgender women are up to 

11 49 times more likely to be diagnosed with HIV than 

12 the general population. Members of communities at 

13 the intersections of these groups are most heavily 

14 impacted. 

15 (4) Pre-exposure prophylaxis (referred to in this 

16 section as ‘‘PrEP’’) is a daily antiretroviral medica17 tion that helps prevent individuals from acquiring 

18 HIV. Daily PrEP use reduces the risk of getting 

19 HIV from sex by over 90 percent. It reduces the risk 

20 of getting HIV from injection drug use by over 70 

21 percent. 

22 (5) Many individuals at risk of exposure to HIV 

23 do not use PrEP. Of the approximately 1,100,000 

24 people in the United States who could benefit from 


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1 PrEP, only 7 percent, or 78,360 individuals, filled 

2 prescriptions for the drug in 2016. 

3 (6) PrEP usage is inconsistent across racial 

4 and gender lines. In 2016, PrEP users were 68.7 

5 percent White, 11.2 percent Black, and 13.1 percent 

6 Latinx. However, individuals eligible for PrEP were 

7 26.3 percent White, 43.7 percent Black, and 24.7 

8 percent Latinx. Additionally, only 2.1 percent of 

9 women eligible for PrEP received a prescription in 

10 2016. 

11 (7) There is currently only one version of PrEP 

12 approved by the Food and Drug Administration, 

13 marketed under the brand name of Truvada, which, 

14 in 2018, had a list price of over $20,000 a year in 

15 the United States. A less expensive, generic version 

16 of PrEP is expected to be available in September 

17 2020, and other types of HIV prevention treat18 ments, including oral pills, vaginal rings, and long19 acting injectables, are currently in the research pipe20 line. 

21 (8) Section 2713 of the Public Health Service 

22 Act (42 U.S.C. 300gg–13) requires most private 

23 health insurance plans to cover preventive services 

24 without cost-sharing, including such services with a 

25 rating of ‘‘A’’ or ‘‘B’’ under recommendations of the 


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1 United States Preventive Services Task Force. On 

2 June 11, 2019, the United States Preventive Serv3 ices Task Force issued a final recommendation giv4 ing an ‘‘A’’ grade for PrEP for individuals at high 

5 risk of HIV; non-grandfathered private health insur6 ance plans will have to cover PrEP for such individ7 uals without cost-sharing by 2021. 

8 (9) Despite such recommendation of the United 

9 States Preventive Services Task Force, access bar10 riers to PrEP remain. Ancillary services necessary to 

11 maintain the PrEP regime, including subsequent 

12 provider visits, clinical testing, and other services, 

13 can remain a cost-burden on patients. Additionally, 

14 the new recommendations are not linked to coverage 

15 requirements for individuals with other types of in16 surance, such as Medicare or Medicaid. 

17 (10) Expanding access to cost-free PrEP and 

18 ancillary services for all individuals, including indi19 viduals who do not have health insurance, is a crit20 ical step towards eliminating HIV transmission. 

21 SEC. 3. COVERAGE OF HIV TESTING AND PREVENTION 

22 SERVICES. 

23 (a) PRIVATE INSURANCE.— 


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1 (1) IN GENERAL.—Section 2713(a) of the Pub2 lic Health Service Act (42 U.S.C. 300gg–13(a)) is 

3 amended— 

4 (A) in paragraph (2), by striking ‘‘; and’’ 

5 and inserting a semicolon; 

6 (B) in paragraph (3), by striking the pe7 riod and inserting a semicolon; 

8 (C) in paragraph (4), by striking the pe9 riod and inserting a semicolon; 

10 (D) in paragraph (5), by striking the pe11 riod and inserting ‘‘; and’’; and 

12 (E) by adding at the end the following: 

13 ‘‘(6) any prescription drug approved by the 

14 Food and Drug Administration for the prevention of 

15 HIV acquisition, laboratory and other diagnostic 

16 procedures associated with the use of such drugs, 

17 and clinical follow up and monitoring, including any 

18 related services recommended in current United 

19 States Public Health Service clinical practice guide20 lines, without limitation.’’. 

21 (2) PROHIBITION ON PREAUTHORIZATION RE22 QUIREMENTS.—Subpart II of part A of title XXVII 

23 of the Public Health Service Act (42 U.S.C. 300gg– 

24 11 et seq.) is amended by adding at the end the fol25 lowing: 


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1 ‘‘SEC. 2729. PROHIBITION ON PREAUTHORIZATION RE2 QUIREMENTS WITH RESPECT TO CERTAIN 

3 SERVICES. 

4 ‘‘A group health plan or a health insurance issuer of5 fering group or individual health insurance coverage shall 

6 not impose any pre-authorization requirements with re7 spect to coverage of the services described in section 

8 2713(a)(6).’’. 

9 (b) COVERAGE UNDER FEDERAL EMPLOYEES

10 HEALTH BENEFITS PROGRAM.—Section 8904 of title 5, 

11 United States Code, is amended by adding at the end the 

12 following: 

13 ‘‘(c) Any health benefits plan offered under this chap14 ter shall include benefits for, and may not impose any cost 

15 sharing requirements for, any prescription drug approved 

16 by the Food and Drug Administration for the prevention 

17 of HIV acquisition, laboratory and other diagnostic proce18 dures associated with the use of such drugs, and clinical 

19 follow up and monitoring, including any related services 

20 recommended in current United States Public Health 

21 Service clinical practice guidelines, without limitation.’’. 

22 (c) MEDICAID.— 

23 (1) IN GENERAL.—Section 1905 of the Social 

24 Security Act (42 U.S.C. 1396d) is amended— 

25 (A) in subsection (a)(4)— 


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1 (i) by striking ‘‘and (D)’’ and insert2 ing ‘‘(D)’’; and 

3 (ii) by inserting ‘‘; and (E) HIV pre4 vention services’’ before the semicolon; and 

5 (B) by adding at the end the following new 

6 subsection: 

7 ‘‘(ff) HIV PREVENTION SERVICES.—For purposes of 

8 subsection (a)(4)(E), the term ‘HIV prevention services’ 

9 means prescription drugs for the prevention of HIV acqui10 sition, laboratory and other diagnostic procedures associ11 ated with the use of such drugs, and clinical follow up 

12 and monitoring, including any related services rec13 ommended in current United States Public Health Service 

14 clinical practice guidelines, without limitation.’’. 

15 (2) NO COST SHARING.—Title XIX of the So16 cial Security Act (42 U.S.C. 1396 et seq.) is amend17 ed— 

18 (A) in section 1916, by inserting ‘‘HIV 

19 prevention services described in section 

20 1905(a)(4)(E),’’ after ‘‘section 1905(a)(4)(C),’’ 

21 each place it appears; and 

22 (B) in section 1916A(b)(3)(B), by adding 

23 at the end the following new clause: 

24 ‘‘(xi) HIV prevention services de25 scribed in section 1905(a)(4)(E).’’. 


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1 (3) INCLUSION IN BENCHMARK COVERAGE.— 

2 Section 1937(b)(7) of the Social Security Act (42 

3 U.S.C. 1396u–7(b)(7)) is amended— 

4 (A) in the paragraph header, by inserting 

5 ‘‘AND HIV PREVENTION SERVICES’’ after ‘‘SUP6 PLIES’’; and 

7 (B) by inserting ‘‘, and, for any individual 

8 described in section 1905(a)(4)(E), medical as9 sistance for HIV prevention services in accord10 ance with such section’’ before the period. 

11 (d) CHIP.— 

12 (1) IN GENERAL.—Section 2103(c) of the So13 cial Security Act (42 U.S.C. 1397cc(c)), as amended 

14 by section 5022 of the SUPPORT for Patients and 

15 Communities Act (Public Law 115–271), is amended 

16 by adding at the end the following new paragraph: 

17 ‘‘(10) HIV PREVENTION SERVICES.—The child 

18 health assistance provided to a targeted low-income 

19 child and the pregnancy-related assistance provided 

20 to a targeted low-income woman shall include cov21 erage of HIV prevention services (as defined in sec22 tion 1905(ff)).’’. 

23 (2) NO COST SHARING.—Section 2103(e)(2) of 

24 the Social Security Act (42 U.S.C. 1397cc(e)(2)) is 

25 amended by inserting ‘‘, for HIV prevention services 


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1 described in subsection (c)(10),’’ after ‘‘subsection 

2 (c)(1)(D)’’. 

3 (3) CONFORMING AMENDMENT.—Section 

4 2103(a) of the Social Security Act (42 U.S.C. 

5 1397cc(a)), as amended by section 5022 of the 

6 SUPPORT for Patients and Communities Act (Pub7 lic Law 115–271), is amended in the matter pre8 ceding paragraph (1) by striking ‘‘and (8)’’ and in9 serting ‘‘(8), and (10)’’. 

10 (4) EFFECTIVE DATE.— 

11 (A) IN GENERAL.—Subject to subpara12 graph (A), the amendments made by subsection 

13 (c) and this subsection shall take effect on Jan14 uary 1, 2021. 

15 (B) DELAY PERMITTED IF STATE LEGISLA16 TION REQUIRED.—In the case of a State plan 

17 approved under title XIX of the Social Security 

18 Act which the Secretary of Health and Human 

19 Services determines requires State legislation 

20 (other than legislation appropriating funds) in 

21 order for the plan to meet the additional re22 quirements imposed by this section, the State 

23 plan shall not be regarded as failing to comply 

24 with the requirements of such title solely on the 

25 basis of the failure of the plan to meet such adVerDate Sep 11 2014 00:36 Jun 22, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1926.IS S1926

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1 ditional requirements before the 1st day of the 

2 1st calendar quarter beginning after the close 

3 of the 1st regular session of the State legisla4 ture that ends after the 1-year period beginning 

5 with the date of the enactment of this section. 

6 For purposes of the preceding sentence, in the 

7 case of a State that has a 2-year legislative ses8 sion, each year of the session is deemed to be 

9 a separate regular session of the State legisla10 ture. 

11 (e) WAIVER OF COST-SHARING UNDER MEDICARE.— 

12 (1) PART B.— 

13 (A) INCLUSION AS A PREVENTIVE SERV14 ICE.—Section 1861(ddd)(3) of the Social Secu15 rity Act (42 U.S.C. 1395x(ddd)(3)) is amended 

16 by adding at the end the following new sub17 paragraph: 

18 ‘‘(D) Drugs or biologicals approved by the 

19 Food and Drug Administration for the preven20 tion of HIV acquisition, laboratory and other 

21 diagnostic procedures associated with the use of 

22 such drugs, and clinical follow up and moni23 toring, including any related services rec24 ommended in current United States Public 


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1 Health Service clinical practice guidelines, with2 out limitation.’’. 

3 (B) ELIMINATION OF COINSURANCE.—Sec4 tion 1833(a)(1) of the Social Security Act (42 

5 U.S.C. 1395l(a)(1)) is amended— 

6 (i) by striking ‘‘and (CC)’’ and insert7 ing ‘‘(CC)’’; and 

8 (ii) by inserting before the semicolon 

9 at the end the following: ‘‘, and (DD) with 

10 respect to preventive services described in 

11 subparagraph (D) of section 1861(ddd)(3), 

12 the amount paid shall be 100 percent of (i) 

13 except as provided in clause (ii), the lesser 

14 of the actual charge for the service or the 

15 amount determined under the fee schedule 

16 that applies to such treatment under this 

17 part, and (ii) in the case of such services 

18 that are covered OPD services (as defined 

19 in subsection (t)(1)(B)), the amount deter20 mined under subsection (t)’’. 

21 (C) EXEMPTION FROM PART B DEDUCT22 IBLE.—Section 1833(b) of the Social Security 

23 Act (42 U.S.C. 1395l(b)) is amended— 

24 (i) in paragraph (9), by striking 

25 ‘‘and’’ at the end; and 


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1 (ii) in paragraph (10), by striking the 

2 period at the end and inserting ‘‘, and (11) 

3 such deductible shall not apply with re4 spect to preventive services described in 

5 subparagraph (D) of section 

6 1861(ddd)(3).’’. 

7 (D) EFFECTIVE DATE.—The amendments 

8 made by this paragraph shall apply to items 

9 and services furnished on or after January 1, 

10 2021. 

11 (2) PART D.— 

12 (A) IN GENERAL.—Section 1860D–2(b) of 

13 the Social Security Act (42 U.S.C. 1395w– 

14 102(b)) is amended— 

15 (i) in paragraph (1)(A), by striking 

16 ‘‘The coverage’’ and inserting ‘‘Subject to 

17 paragraph (8), the coverage’’; 

18 (ii) in paragraph (2)(A), by striking 

19 ‘‘and (D)’’ and inserting ‘‘and (D) and 

20 paragraph (8)’’; 

21 (iii) in paragraph (3)(A), by striking 

22 ‘‘and (4)’’ and inserting ‘‘(4), and (8)’’; 

23 (iv) in paragraph (4)(A)(i), by strik24 ing ‘‘The coverage’’ and inserting ‘‘Subject 

25 to paragraph (8), the coverage’’; and 


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1 (v) by adding at the end the following 

2 new paragraph: 

3 ‘‘(8) LIMITATIONS ON COST-SHARING FOR

4 DRUGS FOR THE PREVENTION OF HIV ACQUISI5 TION.— 

6 ‘‘(A) IN GENERAL.—For plan year 2021 

7 and each subsequent plan year, there shall be 

8 no cost-sharing under this part (including 

9 under section 1814D–14) for covered part D 

10 drugs that are for the prevention of HIV acqui11 sition. 

12 ‘‘(B) COST-SHARING.—For purposes of 

13 subparagraph (A), the elimination of cost-shar14 ing shall include the following: 

15 ‘‘(i) NO APPLICATION OF DEDUCT16 IBLE.—The waiver of the deductible under 

17 paragraph (1). 

18 ‘‘(ii) NO APPLICATION OF COINSUR19 ANCE.—The waiver of coinsurance under 

20 paragraph (2). 

21 ‘‘(iii) NO APPLICATION OF INITIAL

22 COVERAGE LIMIT.—The initial coverage 

23 limit under paragraph (3) shall not apply. 

24 ‘‘(iv) NO COST SHARING ABOVE AN25 NUAL OUT-OF-POCKET THRESHOLD.—The 


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1 waiver of cost sharing under paragraph 

2 (4).’’. 

3 (B) CONFORMING AMENDMENTS TO COST

4 SHARING FOR LOW-INCOME INDIVIDUALS.—Sec5 tion 1860D–14(a) of the Social Security Act 

6 (42 U.S.C. 1395w–114(a)) is amended— 

7 (i) in paragraph (1), in the matter 

8 preceding subparagraph (A), by striking 

9 ‘‘In the case’’ and inserting ‘‘Subject to 

10 section 1860D–2(b)(8), in the case’’; and 

11 (ii) in paragraph (2), in the matter 

12 preceding subparagraph (A), by striking 

13 ‘‘In the case’’ and inserting ‘‘Subject to 

14 section 1860D–2(b)(8), in the case’’. 

15 (f) COVERAGE OF HIV PREVENTION TREATMENT BY

16 DEPARTMENT OF VETERANS AFFAIRS.— 

17 (1) ELIMINATION OF MEDICATION COPAY18 MENTS.—Section 1722A(a) of title 38, United 

19 States Code, is amended by adding at the end the 

20 following new paragraph: 

21 ‘‘(5) Paragraph (1) does not apply to a medication 

22 for the prevention of HIV acquisition.’’. 

23 (2) ELIMINATION OF HOSPITAL CARE AND MED24 ICAL SERVICES COPAYMENTS.—Section 1710 of such 

25 title is amended— 


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1 (A) in subsection (f)— 

2 (i) by redesignating paragraph (5) as 

3 paragraph (6); and 

4 (ii) by inserting after paragraph (4) 

5 the following new paragraph (5): 

6 ‘‘(5) A veteran shall not be liable to the United States 

7 under this subsection for any amounts for laboratory and 

8 other diagnostic procedures associated with the use of any 

9 prescription drug approved by the Food and Drug Admin10 istration for the prevention of HIV acquisition, or for lab11 oratory or other diagnostic procedures associated with the 

12 use of such drugs, or clinical follow up and monitoring, 

13 including any related services recommended in current 

14 United States Public Health Service clinical practice 

15 guidelines, without limitation.’’; and 

16 (B) in subsection (g)(3), by adding at the 

17 end the following new subparagraph: 

18 ‘‘(C) Any prescription drug approved by the 

19 Food and Drug Administration for the prevention of 

20 HIV acquisition, laboratory and other diagnostic 

21 procedures associated with the use of such drugs, 

22 and clinical follow up and monitoring, including any 

23 related services recommended in current United 

24 States Public Health Service clinical practice guide25 lines, without limitation.’’. 


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1 (3) INCLUSION AS PREVENTIVE HEALTH SERV2 ICE.—Section 1701(9) of such title is amended— 

3 (A) in subparagraph (K), by striking ‘‘; 

4 and’’ and inserting a semicolon; 

5 (B) by redesignating subparagraph (L) as 

6 subparagraph (M); and 

7 (C) by inserting after subparagraph (K) 

8 the following new subparagraph (L): 

9 ‘‘(L) any prescription drug approved by 

10 the Food and Drug Administration for the pre11 vention of HIV acquisition, laboratory and 

12 other diagnostic procedures associated with the 

13 use of such drugs, and clinical follow up and 

14 monitoring, including any related services rec15 ommended in current United States Public 

16 Health Service clinical practice guidelines, with17 out limitation; and’’. 

18 (g) COVERAGE OF HIV PREVENTION TREATMENT BY

19 DEPARTMENT OF DEFENSE.— 

20 (1) IN GENERAL.—Chapter 55 of title 10, 

21 United States Code, is amended by inserting after 

22 section 1079c the following new section: 

23 ‘‘§ 1079d. Coverage of HIV prevention treatment 

24 ‘‘(a) IN GENERAL.—The Secretary of Defense shall 

25 ensure coverage under the TRICARE program of HIV 


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1 prevention treatment described in subsection (b) for any 

2 beneficiary under section 1074(a) of this title. 

3 ‘‘(b) HIV PREVENTION TREATMENT DESCRIBED.— 

4 HIV prevention treatment described in this subsection in5 cludes any prescription drug approved by the Food and 

6 Drug Administration for the prevention of HIV acquisi7 tion, laboratory and other diagnostic procedures associ8 ated with the use of such drugs, and clinical follow up 

9 and monitoring, including any related services rec10 ommended in current United States Public Health Service 

11 clinical practice guidelines, without limitation. 

12 ‘‘(c) NO COST-SHARING.—Notwithstanding section 

13 1075, 1075a, or 1074g(a)(6) of this title or any other pro14 vision of law, there is no cost-sharing requirement for HIV 

15 prevention treatment covered under this section.’’. 

16 (2) CLERICAL AMENDMENT.—The table of sec17 tions at the beginning of such chapter is amended 

18 by inserting after the item relating to section 1079c 

19 the following new item: 

‘‘1079d. Coverage of HIV prevention treatment.’’. 

20 (h) INDIAN HEALTH SERVICE TESTING, MONI21 TORING, AND PRESCRIPTION DRUGS FOR THE PREVEN22 TION OF HIV ACQUISITION.—The Indian Health Care Im23 provement Act is amended by inserting after section 223 

24 (25 U.S.C. 1621v) the following: 


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1 ‘‘SEC. 224. TESTING, MONITORING, AND PRESCRIPTION 

2 DRUGS FOR THE PREVENTION OF HIV ACQUI3 SITION. 

4 ‘‘(a) IN GENERAL.—The Secretary, acting through 

5 the Service, Indian tribes, and tribal organizations, shall 

6 provide funding for any prescription drug approved by the 

7 Food and Drug Administration for the prevention of HIV 

8 acquisition, laboratory and other diagnostic procedures as9 sociated with the use of such drugs, and clinical follow 

10 up and monitoring, including any related services rec11 ommended in current United States Public Health Service 

12 clinical practice guidelines, without limitation. 

13 ‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—There 

14 are authorized to be appropriated to carry out this section 

15 such sums as may be necessary.’’. 

16 (i) EFFECTIVE DATE.—The amendments made by 

17 subsections (a), (b), (e), (f), (g), and (h) shall take effect 

18 with respect to plan years beginning on or after January 

19 1, 2021. 

20 SEC. 4. PROHIBITION ON DENIAL OF COVERAGE OR IN21 CREASE IN PREMIUMS OF LIFE, DISABILITY, 

22 OR LONG-TERM CARE INSURANCE FOR INDI23 VIDUALS TAKING MEDICATION FOR THE PRE24 VENTION OF HIV ACQUISITION. 

25 (a) PROHIBITION.—Notwithstanding any other provi26 sion of law, it shall be unlawful to— 


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1 (1) decline or limit coverage of a person under 

2 any life insurance policy, disability insurance policy, 

3 or long-term care insurance policy, on account of the 

4 individual taking medication for the purpose of pre5 venting the acquisition of HIV; 

6 (2) preclude an individual from taking medica7 tion for the purpose of preventing the acquisition of 

8 HIV as a condition of receiving a life insurance pol9 icy, disability insurance policy, or long-term care in10 surance policy; 

11 (3) consider whether an individual is taking 

12 medication for the purpose of preventing the acquisi13 tion of HIV in determining the premium rate for 

14 coverage of such individual under a life insurance 

15 policy, disability insurance policy, or long-term care 

16 insurance policy; or 

17 (4) otherwise discriminate in the offering, 

18 issuance, cancellation, amount of such coverage, 

19 price, or any other condition of a life insurance pol20 icy, disability insurance policy, or long-term care in21 surance policy for an individual, based solely and 

22 without any additional actuarial risks upon whether 

23 the individual is taking medication for the purpose 

24 of preventing the acquisition of HIV. 


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1 (b) ENFORCEMENT.—A State insurance regulator 

2 may take such actions to enforce subsection (a) as are spe3 cifically authorized under the laws of such State. 

4 (c) DEFINITIONS.—In this section: 

5 (1) DISABILITY INSURANCE POLICY.—The term 

6 ‘‘disability insurance policy’’ means a contract under 

7 which an entity promises to pay a person a sum of 

8 money in the event that an illness or injury resulting 

9 in a disability prevents such person from working. 

10 (2) LIFE INSURANCE POLICY.—The term ‘‘life 

11 insurance policy’’ means a contract under which an 

12 entity promises to pay a designated beneficiary a 

13 sum of money upon the death of the insured. 

14 (3) LONG-TERM CARE INSURANCE POLICY.— 

15 The term ‘‘long-term care insurance policy’’ means 

16 a contract for which the only insurance protection 

17 provided under the contract is coverage of qualified 

18 long-term care services (as defined in section 

19 7702B(c) of the Internal Revenue Code of 1986). 

20 SEC. 5. PUBLIC EDUCATION CAMPAIGN. 

21 Part P of title III of the Public Health Service Act 

22 (42 U.S.C. 280g et seq.) is amended by adding at the end 

23 the following: 


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1 ‘‘SEC. 399V–7. PRE-EXPOSURE PROPHYLAXIS PUBLIC EDU2 CATION CAMPAIGN. 

3 ‘‘(a) IN GENERAL.—The Secretary, acting through 

4 the Director of the Centers for Disease Control and Pre5 vention, shall establish a public health campaign for the 

6 purpose of educating the public on medication for the pre7 vention of HIV acquisition. 

8 ‘‘(b) REQUIREMENTS.—In carrying out this section, 

9 the Secretary shall ensure cultural competency and effi10 cacy within high-need communities in which PrEP is un11 derutilized by developing the campaign in collaboration 

12 with organizations that are indigenous to communities 

13 that are overrepresented in the domestic HIV epidemic, 

14 including communities of color and the lesbian, gay, bisex15 ual, transgender, and queer community. The Secretary 

16 shall ensure that the campaign is designed to increase 

17 awareness of the safety and effectiveness of PrEP, the rec18 ommended clinical practices for providing PrEP-related 

19 clinical care, and the local availability of PrEP providers, 

20 and to counter stigma associated with the use of PrEP. 

21 ‘‘(c) EVALUATION OF PROGRAM.—The Secretary 

22 shall develop measures to evaluate the effectiveness of ac23 tivities conducted under this section that are aimed at re24 ducing disparities in access to PrEP and supporting the 

25 local community. Such measures shall evaluate community 

26 outreach activities, language services, workforce cultural 


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1 competence, and other areas as determined by the Sec2 retary. 

3 ‘‘(d) PREP.—In this section, the term ‘PrEP’ means 

4 any drug approved by the Food and Drug Administration 

5 for the purpose of pre-exposure prophylaxis with respect 

6 to HIV. 

7 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

8 are authorized to be appropriated such sums as may be 

9 necessary for each of fiscal years 2021 through 2026.’’. 

10 SEC. 6. PATIENT CONFIDENTIALITY. 

11 The Secretary of Health and Human Services shall 

12 amend the regulations promulgated under section 264(c) 

13 of the Health Insurance Portability and Accountability 

14 Act of 1996 (42 U.S.C. 1320d–2 note), as necessary, to 

15 ensure that individuals are able to access the benefits de16 scribed in section 2713(a)(6) under a family plan without 

17 any other individual enrolled in such family plan, including 

18 a primary subscriber of or policyholder, being informed of 

19 such use of such benefits. 

20 SEC. 7. PRE-EXPOSURE PROPHYLAXIS FUNDING. 

21 (a) IN GENERAL.—Not later than 1 year after the 

22 date of enactment of this Act, the Secretary of Health and 

23 Human Services (in this Act referred to as the ‘‘Sec24 retary’’) shall establish a program that provides grants to 

25 States, territories, and Indian Tribes for the establishment 


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1 and support of pre-exposure prophylaxis (referred to in 

2 this section as ‘‘PrEP’’) programs, or establishes a pro3 gram for providing Federal funding directly to eligible en4 tities within a State, territory, or Indian Tribal territory, 

5 in the case of a State, territory, or Indian Tribe that does 

6 not apply for such a grant. 

7 (b) GRANT PROGRAM.— 

8 (1) APPLICATIONS.—To be eligible to receive a 

9 grant under subsection (a), a State, territory, or In10 dian Tribe shall— 

11 (A) submit an application to the Secretary 

12 at such time, in such manner, and containing 

13 such information as the Secretary may require, 

14 including a description of how any funds award15 ed will be used and a plan describing how any 

16 funds awarded will be used to increase access to 

17 PrEP for uninsured individuals and reduce dis18 parities in access to PrEP; and 

19 (B) appoint a PrEP grant administrator to 

20 manage the program. 

21 (2) USE OF FUNDS.—Any State, Territory of 

22 the United States, or Indian Tribe that is awarded 

23 funds under subsection (a) shall use such funds for 

24 eligible PrEP expenses. 

25 (c) FEDERAL PROGRAM.— 


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1 (1) IN GENERAL.—In the case of a State, terri2 tory, or Indian Tribe that does not submit an appli3 cation under subsection (b), the Secretary shall pro4 vide funding to any of the following, within the ap5 plicable State, territory, or Indian Tribal territory: 

6 (A) Federally qualified health centers (as 

7 defined in section 1861(aa)(4) of the Social Se8 curity Act (42 U.S.C. 1395x(aa)(4)). 

9 (B) Family planning grantees (other than 

10 States) funded under section 1001 of the Public 

11 Health Service Act (42 U.S.C. 300). 

12 (C) Rural health clinics (as defined in sec13 tion 1861(aa)(2) of the Social Security Act (42 

14 U.S.C. 1395x(aa)(2)). 

15 (D) Health facilities operated by or pursu16 ant to a contract with the Indian Health Serv17 ice. 

18 (E) Community-based organizations, clin19 ics, hospitals, and other health facilities that 

20 provide services to individuals at risk for or liv21 ing with HIV. 

22 (F) Nonprofit private entities providing 

23 comprehensive primary care to populations at 

24 risk of HIV, including faith-based and commu25 nity-based organizations. 


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1 (2) USE OF FUNDS.—Any entity receiving fund2 ing under paragraph (1) shall use such funds for eli3 gible PrEP expenses. 

4 (d) ELIGIBLE PREP EXPENSES.— 

5 (1) IN GENERAL.—The Secretary shall publish 

6 a list of expenses that qualify as eligible PrEP ex7 penses for purposes of this section. 

8 (2) INCLUSIONS.—Such list shall include— 

9 (A) any prescription drug approved by the 

10 Food and Drug Administration for the preven11 tion of HIV acquisition, laboratory and other 

12 diagnostic procedures associated with the use of 

13 such drugs, and clinical follow up and moni14 toring, including any related services rec15 ommended in current United States Public 

16 Health Service clinical practice guidelines, with17 out limitation; 

18 (B) outreach and public education activi19 ties directed toward populations overrepresented 

20 in the domestic HIV epidemic that increase 

21 awareness about the existence of PrEP, provide 

22 education about access to and health care cov23 erage of PrEP, and counter stigma associated 

24 with the use of PrEP; and 


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1 (C) outreach activities directed toward 

2 physicians and other providers that provide 

3 education about PrEP. 

4 (e) REPORT TO CONGRESS.—The Secretary shall, in 

5 each of the first 5 years beginning one year after the date 

6 of the enactment of this Act, submit to Congress, and 

7 make public on the internet website of Department of 

8 Health and Human Services, a report on the impact of 

9 any grants provided to States, territories, and Indian 

10 Tribes for the establishment and support of pre-exposure 

11 prophylaxis programs under this section. 

12 (f) AUTHORIZATION OF APPROPRIATIONS.—There 

13 are authorized to be appropriated to carry out this section 

14 $60,000,000 for each of the first 5 fiscal years beginning 

15 after the date of the enactment of this section. 

16 SEC. 8. CLARIFICATION. 

17 This Act, including the amendments made by this 

18 Act, shall apply notwithstanding any other provision of 

19 law, including Public Law 103–141. 

20 SEC. 9. PRIVATE RIGHT OF ACTION. 

21 Any person aggrieved by a violation of this Act, in22 cluding the amendments made by this Act, may commence 

23 a civil action in an appropriate United States District 

24 Court or other court of competent jurisdiction to obtain 

25 relief as allowed by law as either an individual or member 


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1 of a class. If the plaintiff is the prevailing party in such 

2 an action, the court shall order the defendant to pay the 

3 costs and reasonable attorney fees of the plaintiff. 

Æ 


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