I 

116TH CONGRESS 

1ST SESSION H. R. 3815 

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

of HIV. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 17, 2019 

Mr. SCHIFF (for himself, Mrs. WATSON COLEMAN, Ms. LEE of California, Mr. 

KHANNA, Ms. MUCARSEL-POWELL, Mr. RUSH, Mr. CRIST, Ms. 

BARRAGA ́N, Ms. HAALAND, Mr. PAPPAS, Mr. MOULTON, Mr. COX of 

California, Mr. COHEN, and Ms. PRESSLEY) introduced the following bill; 

which was referred to the Committee on Energy and Commerce, and in 

addition to the Committees on Oversight and Reform, Veterans’ Affairs, 

Ways and Means, Natural Resources, Armed Services, 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. 

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’’. 


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1 SEC. 2. FINDINGS. 

2 Congress finds as follows: 

3 (1) The Centers for Disease Control and Pre4 vention estimates that approximately 1,100,000 peo5 ple in the United States are living with HIV. 

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

7 of HIV in the United States. 

8 (3) HIV disproportionately impacts gay and bi9 sexual men, transgender women, and, in particular, 

10 people of color. For example, in 2017 approximately 

11 66 percent of new HIV diagnoses were among gay 

12 and bisexual men, 43 percent of new HIV diagnoses 

13 were among Black people, and 26 percent of new 

14 HIV diagnoses were among Latinx people. Recent 

15 studies suggest that transgender women are up to 

16 49 times more likely to be diagnosed with HIV than 

17 the general population. Members of communities at 

18 the intersections of these groups are most heavily 

19 impacted. 

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

21 section as ‘‘PrEP’’) is a daily antiretroviral medica22 tion that helps prevent individuals from acquiring 

23 HIV. Daily PrEP use reduces the risk of getting 

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

25 of getting HIV from injection drug use by over 70 

26 percent. 


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

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

3 people in the United States who could benefit from 

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

5 prescriptions for the drug in 2016. 

6 (6) PrEP usage is inconsistent across racial 

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

8 percent White, 11.2 percent Black, and 13.1 percent 

9 Latinx. However, individuals eligible for PrEP were 

10 26.3 percent White, 43.7 percent Black, and 24.7 

11 percent Latinx. Additionally, only 2.1 percent of 

12 women eligible for PrEP received a prescription in 

13 2016. 

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

15 approved by the Food and Drug Administration, 

16 marketed under the brand name of Truvada, which, 

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

18 the United States. A less expensive, generic version 

19 of PrEP is expected to be available in September 

20 2020, and other types of HIV prevention treat21 ments, including oral pills, vaginal rings, and long22 acting injectables, are currently in the research pipe23 line. 

24 (8) Section 2713 of the Public Health Service 

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


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1 health insurance plans to cover preventive services 

2 without cost sharing, including such services with a 

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

4 United States Preventive Services Task Force. On 

5 June 11, 2019, the United States Preventive Serv6 ices Task Force issued a final recommendation giv7 ing an ‘‘A’’ grade for PrEP for individuals at high 

8 risk of HIV; non-grandfathered private health insur9 ance plans will have to cover PrEP for such individ10 uals without cost sharing by 2021. 

11 (9) Despite such recommendation of the United 

12 States Preventive Services Task Force, access bar13 riers to PrEP remain. Ancillary services necessary to 

14 maintain the PrEP regime, including subsequent 

15 provider visits, clinical testing, and other services, 

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

17 the new recommendations are not linked to coverage 

18 requirements for individuals with other types of in19 surance, such as Medicare or Medicaid. 

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

21 ancillary services for all individuals, including indi22 viduals who do not have health insurance, is a crit23 ical step towards eliminating HIV transmission. 


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1 SEC. 3. COVERAGE OF HIV TESTING AND PREVENTION 

2 SERVICES. 

3 (a) PRIVATE INSURANCE.— 

4 (1) IN GENERAL.—Section 2713(a) of the Pub5 lic Health Service Act (42 U.S.C. 300gg–13(a)) is 

6 amended— 

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

8 and inserting a semicolon; 

9 (B) in paragraph (3), by striking the pe10 riod and inserting a semicolon; 

11 (C) in paragraph (4), by striking the pe12 riod and inserting a semicolon; 

13 (D) in paragraph (5), by striking the pe14 riod and inserting ‘‘; and’’; and 

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

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

17 Food and Drug Administration for the prevention of 

18 HIV acquisition, laboratory and other diagnostic 

19 procedures associated with the use of such drugs, 

20 and clinical follow up and monitoring, including any 

21 related services recommended in current United 

22 States Public Health Service clinical practice guide23 lines, without limitation.’’. 

24 (2) PROHIBITION ON PREAUTHORIZATION RE25 QUIREMENTS.—Subpart II of part A of title XXVII 

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


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1 11 et seq.) is amended by adding at the end the fol2 lowing: 

3 ‘‘SEC. 2729. PROHIBITION ON PREAUTHORIZATION RE4 QUIREMENTS WITH RESPECT TO CERTAIN 

5 SERVICES. 

6 ‘‘A group health plan or a health insurance issuer of7 fering group or individual health insurance coverage shall 

8 not impose any pre-authorization requirements with re9 spect to coverage of the services described in section 

10 2713(a)(6).’’. 

11 (b) COVERAGE UNDER FEDERAL EMPLOYEES

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

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

14 following: 

15 ‘‘(c) Any health benefits plan offered under this chap16 ter shall include benefits for, and may not impose any cost 

17 sharing requirements for, any prescription drug approved 

18 by the Food and Drug Administration for the prevention 

19 of HIV acquisition, laboratory and other diagnostic proce20 dures associated with the use of such drugs, and clinical 

21 follow up and monitoring, including any related services 

22 recommended in current United States Public Health 

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

24 (c) MEDICAID.— 


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

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

3 (A) in subsection (a)(4)— 

4 (i) by striking ‘‘and (D)’’ and insert5 ing ‘‘(D)’’; and 

6 (ii) by inserting ‘‘; and (E) HIV pre7 vention services’’ before the semicolon; and 

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

9 subsection: 

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

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

12 means prescription drugs for the prevention of HIV acqui13 sition, laboratory and other diagnostic procedures associ14 ated with the use of such drugs, and clinical follow up 

15 and monitoring, including any related services rec16 ommended in current United States Public Health Service 

17 clinical practice guidelines, without limitation.’’. 

18 (2) NO COST SHARING.—Title XIX of the So19 cial Security Act (42 U.S.C. 1396 et seq.) is amend20 ed— 

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

22 prevention services described in section 

23 1905(a)(4)(E),’’ after ‘‘section 1905(a)(4)(C),’’ 

24 each place it appears; and 


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

2 at the end the following new clause: 

3 ‘‘(xi) HIV prevention services de4 scribed in section 1905(a)(4)(E).’’. 

5 (3) INCLUSION IN BENCHMARK COVERAGE.— 

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

7 U.S.C. 1396u–7(b)(7)) is amended— 

8 (A) in the paragraph header, by inserting 

9 ‘‘AND HIV PREVENTION SERVICES’’ after ‘‘SUP10 PLIES’’; and 

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

12 described in section 1905(a)(4)(E), medical as13 sistance for HIV prevention services in accord14 ance with such section’’ before the period. 

15 (d) CHIP.— 

16 (1) IN GENERAL.—Section 2103(c) of the So17 cial Security Act (42 U.S.C. 1397cc(c)), as amended 

18 by section 5022 of the SUPPORT for Patients and 

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

20 by adding at the end the following new paragraph: 

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

22 health assistance provided to a targeted low-income 

23 child and the pregnancy-related assistance provided 

24 to a targeted low-income woman shall include covVerDate Sep 11 2014 04:29 Aug 01, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H3815.IH H3815

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1 erage of HIV prevention services (as defined in sec2 tion 1905(ff)).’’. 

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

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

5 amended by inserting ‘‘, for HIV prevention services 

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

7 (c)(1)(D)’’. 

8 (3) CONFORMING AMENDMENT.—Section 

9 2103(a) of the Social Security Act (42 U.S.C. 

10 1397cc(a)), as amended by section 5022 of the 

11 SUPPORT for Patients and Communities Act (Pub12 lic Law 115–271), is amended in the matter pre13 ceding paragraph (1) by striking ‘‘and (8)’’ and in14 serting ‘‘(8), and (10)’’. 

15 (4) EFFECTIVE DATE.— 

16 (A) IN GENERAL.—Subject to subpara17 graph (A), the amendments made by subsection 

18 (c) and this subsection shall take effect on Jan19 uary 1, 2021. 

20 (B) DELAY PERMITTED IF STATE LEGISLA21 TION REQUIRED.—In the case of a State plan 

22 approved under title XIX of the Social Security 

23 Act which the Secretary of Health and Human 

24 Services determines requires State legislation 

25 (other than legislation appropriating funds) in 


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1 order for the plan to meet the additional re2 quirements imposed by this section, the State 

3 plan shall not be regarded as failing to comply 

4 with the requirements of such title solely on the 

5 basis of the failure of the plan to meet such ad6 ditional requirements before the 1st day of the 

7 1st calendar quarter beginning after the close 

8 of the 1st regular session of the State legisla9 ture that ends after the 1-year period beginning 

10 with the date of the enactment of this section. 

11 For purposes of the preceding sentence, in the 

12 case of a State that has a 2-year legislative ses13 sion, each year of the session is deemed to be 

14 a separate regular session of the State legisla15 ture. 

16 (e) WAIVER OF COST SHARING UNDER MEDICARE.— 

17 (1) PART B.— 

18 (A) INCLUSION AS A PREVENTIVE SERV19 ICE.—Section 1861(ddd)(3) of the Social Secu20 rity Act (42 U.S.C. 1395x(ddd)(3)) is amended 

21 by adding at the end the following new sub22 paragraph: 

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

24 Food and Drug Administration for the preven25 tion of HIV acquisition, laboratory and other 


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1 diagnostic procedures associated with the use of 

2 such drugs, and clinical follow up and moni3 toring, including any related services rec4 ommended in current United States Public 

5 Health Service clinical practice guidelines, with6 out limitation.’’. 

7 (B) ELIMINATION OF COINSURANCE.—Sec8 tion 1833(a)(1) of the Social Security Act (42 

9 U.S.C. 1395l(a)(1)) is amended— 

10 (i) by striking ‘‘and (CC)’’ and insert11 ing ‘‘(CC)’’; and 

12 (ii) by inserting before the semicolon 

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

14 respect to preventive services described in 

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

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

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

18 of the actual charge for the service or the 

19 amount determined under the fee schedule 

20 that applies to such treatment under this 

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

22 that are covered OPD services (as defined 

23 in subsection (t)(1)(B)), the amount deter24 mined under subsection (t)’’. 


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1 (C) EXEMPTION FROM PART B DEDUCT2 IBLE.—Section 1833(b) of the Social Security 

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

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

5 ‘‘and’’ at the end; and 

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

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

8 such deductible shall not apply with re9 spect to preventive services described in 

10 subparagraph (D) of section 

11 1861(ddd)(3).’’. 

12 (D) EFFECTIVE DATE.—The amendments 

13 made by this paragraph shall apply to items 

14 and services furnished on or after January 1, 

15 2021. 

16 (2) PART D.— 

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

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

19 102(b)) is amended— 

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

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

22 paragraph (8), the coverage’’; 

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

24 ‘‘and (D)’’ and inserting ‘‘and (D) and 

25 paragraph (8)’’; 


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

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

3 (iv) in paragraph (4)(A)(i), by strik4 ing ‘‘The coverage’’ and inserting ‘‘Subject 

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

6 (v) by adding at the end the following 

7 new paragraph: 

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

9 DRUGS FOR THE PREVENTION OF HIV ACQUISI10 TION.— 

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

12 and each subsequent plan year, there shall be 

13 no cost-sharing under this part (including 

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

15 drugs that are for the prevention of HIV acqui16 sition. 

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

18 subparagraph (A), the elimination of cost-shar19 ing shall include the following: 

20 ‘‘(i) NO APPLICATION OF DEDUCT21 IBLE.—The waiver of the deductible under 

22 paragraph (1). 

23 ‘‘(ii) NO APPLICATION OF COINSUR24 ANCE.—There waiver of coinsurance under 

25 paragraph (2). 


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1 ‘‘(iii) NO APPLICATION OF INITIAL

2 COVERAGE LIMIT.—The initial coverage 

3 limit under paragraph (3) shall not apply. 

4 ‘‘(iv) NO COST SHARING ABOVE AN5 NUAL OUT-OF-POCKET THRESHOLD.—The 

6 waiver of cost sharing under paragraph 

7 (4).’’. 

8 (B) CONFORMING AMENDMENTS TO COST

9 SHARING FOR LOW-INCOME INDIVIDUALS.—Sec10 tion 1860D–14(a) of the Social Security Act 

11 (42 U.S.C. 1395w–114(a)) is amended— 

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

13 preceding subparagraph (A), by striking 

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

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

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

17 preceding subparagraph (A), by striking 

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

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

20 (f) COVERAGE OF HIV PREVENTION TREATMENT BY

21 DEPARTMENT OF VETERANS AFFAIRS.— 

22 (1) ELIMINATION OF MEDICATION COPAY23 MENTS.—Section 1722A(a) of title 38, United 

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

25 following new paragraph: 


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

2 for the prevention of HIV acquisition.’’. 

3 (2) ELIMINATION OF HOSPITAL CARE AND MED4 ICAL SERVICES COPAYMENTS.—Section 1710 of such 

5 title is amended— 

6 (A) in subsection (f)— 

7 (i) by redesignating paragraph (5) as 

8 paragraph (6); and 

9 (ii) by inserting after paragraph (4) 

10 the following new paragraph (5): 

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

12 under this subsection for any amounts for laboratory and 

13 other diagnostic procedures associated with the use of any 

14 prescription drug approved by the Food and Drug Admin15 istration for the prevention of HIV acquisition, or for lab16 oratory or other diagnostic procedures associated with the 

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

18 including any related services recommended in current 

19 United States Public Health Service clinical practice 

20 guidelines, without limitation.’’; and 

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

22 end the following new subparagraph: 

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

24 Food and Drug Administration for the prevention of 

25 HIV acquisition, laboratory and other diagnostic 


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1 procedures associated with the use of such drugs, 

2 and clinical follow up and monitoring, including any 

3 related services recommended in current United 

4 States Public Health Service clinical practice guide5 lines, without limitation.’’. 

6 (3) INCLUSION AS PREVENTIVE HEALTH SERV7 ICE.—Section 1701(9) of such title is amended— 

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

9 and’’ and inserting a semicolon; 

10 (B) by redesignating subparagraph (L) as 

11 subparagraph (M); and 

12 (C) by inserting after subparagraph (K) 

13 the following new subparagraph (L): 

14 ‘‘(L) any prescription drug approved by 

15 the Food and Drug Administration for the pre16 vention of HIV acquisition, laboratory and 

17 other diagnostic procedures associated with the 

18 use of such drugs, and clinical follow up and 

19 monitoring, including any related services rec20 ommended in current United States Public 

21 Health Service clinical practice guidelines, with22 out limitation; and’’. 

23 (g) COVERAGE OF HIV PREVENTION TREATMENT BY

24 DEPARTMENT OF DEFENSE.— 


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

2 United States Code, is amended by inserting after 

3 section 1079c the following new section: 

4 ‘‘§ 1079d. Coverage of HIV prevention treatment 

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

6 ensure coverage under the TRICARE program of HIV 

7 prevention treatment described in subsection (b) for any 

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

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

10 HIV prevention treatment described in this subsection in11 cludes any prescription drug approved by the Food and 

12 Drug Administration for the prevention of HIV acquisi13 tion, laboratory and other diagnostic procedures associ14 ated with the use of such drugs, and clinical follow up 

15 and monitoring, including any related services rec16 ommended in current United States Public Health Service 

17 clinical practice guidelines, without limitation. 

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

19 1075, 1075a, or 1074g(a)(6) of this title or any other pro20 vision of law, there is no cost-sharing requirement for HIV 

21 prevention treatment covered under this section.’’. 

22 (2) CLERICAL AMENDMENT.—The table of sec23 tions at the beginning of such chapter is amended 

24 by inserting after the item relating to section 1079c 

25 the following new item: 

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


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1 (h) INDIAN HEALTH SERVICE TESTING, MONI2 TORING, AND PRESCRIPTION DRUGS FOR THE PREVEN3 TION OF HIV ACQUISITION.—The Indian Health Care Im4 provement Act is amended by inserting after section 223 

5 (25 U.S.C. 1621v) the following: 

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

7 DRUGS FOR THE PREVENTION OF HIV ACQUI8 SITION. 

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

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

11 provide funding for any prescription drug approved by the 

12 Food and Drug Administration for the prevention of HIV 

13 acquisition, laboratory and other diagnostic procedures as14 sociated with the use of such drugs, and clinical follow 

15 up and monitoring, including any related services rec16 ommended in current United States Public Health Service 

17 clinical practice guidelines, without limitation. 

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

19 are authorized to be appropriated to carry out this section 

20 such sums as may be necessary.’’. 

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

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

23 with respect to plan years beginning on or after January 

24 1, 2021. 


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1 SEC. 4. PROHIBITION ON DENIAL OF COVERAGE OR IN2 CREASE IN PREMIUMS OF LIFE, DISABILITY, 

3 OR LONG-TERM CARE INSURANCE FOR INDI4 VIDUALS TAKING MEDICATION FOR THE PRE5 VENTION OF HIV ACQUISITION. 

6 (a) PROHIBITION.—Notwithstanding any other provi7 sion of law, it shall be unlawful to— 

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

9 any life insurance policy, disability insurance policy, 

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

11 individual taking medication for the purpose of pre12 venting the acquisition of HIV; 

13 (2) preclude an individual from taking medica14 tion for the purpose of preventing the acquisition of 

15 HIV as a condition of receiving a life insurance pol16 icy, disability insurance policy, or long-term care in17 surance policy; 

18 (3) consider whether an individual is taking 

19 medication for the purpose of preventing the acquisi20 tion of HIV in determining the premium rate for 

21 coverage of such individual under a life insurance 

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

23 insurance policy; or 

24 (4) otherwise discriminate in the offering, 

25 issuance, cancellation, amount of such coverage, 

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1 icy, disability insurance policy, or long-term care in2 surance policy for an individual, based solely and 

3 without any additional actuarial risks upon whether 

4 the individual is taking medication for the purpose 

5 of preventing the acquisition of HIV. 

6 (b) ENFORCEMENT.—A State insurance regulator 

7 may take such actions to enforce subsection (a) as are spe8 cifically authorized under the laws of such State. 

9 (c) DEFINITIONS.—In this section: 

10 (1) DISABILITY INSURANCE POLICY.—The term 

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

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

13 money in the event that an illness or injury resulting 

14 in a disability prevents such person from working. 

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

16 insurance policy’’ means a contract under which an 

17 entity promises to pay a designated beneficiary a 

18 sum of money upon the death of the insured. 

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

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

21 a contract for which the only insurance protection 

22 provided under the contract is coverage of qualified 

23 long-term care services (as defined in section 

24 7702B(c) of the Internal Revenue Code of 1986). 


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1 SEC. 5. PUBLIC EDUCATION CAMPAIGN. 

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

3 (42 U.S.C. 280g et seq.) is amended by adding at the end 

4 the following: 

5 ‘‘SEC. 399V–7. PRE-EXPOSURE PROPHYLAXIS PUBLIC EDU6 CATION CAMPAIGN. 

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

8 the Director of the Centers for Disease Control and Pre9 vention, shall establish a public health campaign for the 

10 purpose of educating the public on medication for the pre11 vention of HIV acquisition. 

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

13 the Secretary shall ensure cultural competency and effi14 cacy within high-need communities in which PrEP is un15 derutilized by developing the campaign in collaboration 

16 with organizations that are indigenous to communities 

17 that are overrepresented in the domestic HIV epidemic, 

18 including communities of color and the lesbian, gay, bisex19 ual, transgender, and queer community. The Secretary 

20 shall ensure that the campaign is designed to increase 

21 awareness of the safety and effectiveness of PrEP, the rec22 ommended clinical practices for providing PrEP-related 

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

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

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

26 shall develop measures to evaluate the effectiveness of acVerDate Sep 11 2014 04:29 Aug 01, 2019 Jkt 089200 PO 00000 Frm 00021 Fmt 6652 Sfmt 6201 E:\BILLS\H3815.IH H3815

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1 tivities conducted under this section that are aimed at re2 ducing disparities in access to PrEP and supporting the 

3 local community. Such measures shall evaluate community 

4 outreach activities, language services, workforce cultural 

5 competence, and other areas as determined by the Sec6 retary. 

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

8 any drug approved by the Food and Drug Administration 

9 for the purpose of pre-exposure prophylaxis with respect 

10 to HIV. 

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

12 are authorized to be appropriated such sums as may be 

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

14 SEC. 6. PATIENT CONFIDENTIALITY. 

15 The Secretary of Health and Human Services shall 

16 amend the regulations promulgated under section 264(c) 

17 of the Health Insurance Portability and Accountability 

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

19 ensure that individuals are able to access the benefits de20 scribed in section 2713(a)(6) under a family plan without 

21 any other individual enrolled in such family plan, including 

22 a primary subscriber of or policyholder, being informed of 

23 such use of such benefits. 


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1 SEC. 7. PRE-EXPOSURE PROPHYLAXIS FUNDING. 

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

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

4 Human Services (in this Act referred to as the ‘‘Sec5 retary’’) shall establish a program that provides grants to 

6 States, territories, and Indian Tribes for the establishment 

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

8 this section as ‘‘PrEP’’) programs, or establishes a pro9 gram for providing Federal funding directly to eligible en10 tities within a State, territory, or Indian Tribal territory, 

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

12 not apply for such a grant. 

13 (b) GRANT PROGRAM.— 

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

15 grant under subsection (a), a State, territory, or In16 dian Tribe shall— 

17 (A) submit an application to the Secretary 

18 at such time, in such manner, and containing 

19 such information as the Secretary may require, 

20 including a description of how any funds award21 ed will be used and a plan describing how any 

22 funds awarded will be used to increase access to 

23 PrEP for uninsured individuals and reduce dis24 parities in access to PrEP; and 

25 (B) appoint a PrEP grant administrator to 

26 manage the program. 


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

2 the United States, or Indian tribe that is awarded 

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

4 eligible PrEP expenses. 

5 (c) FEDERAL PROGRAM.— 

6 (1) IN GENERAL.—In the case of a State, terri7 tory, or Indian Tribe that does not submit an appli8 cation under subsection (b), the Secretary shall pro9 vide funding to any of the following, within the ap10 plicable State, territory, or Indian Tribal territory: 

11 (A) Federally qualified health centers (as 

12 defined in section 1861(aa)(4) of the Social Se13 curity Act (42 U.S.C. 1395x(aa)(4))). 

14 (B) Family planning grantees (other than 

15 States) funded under section 1001 of the Public 

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

17 (C) Rural health clinics (as defined in sec18 tion 1861(aa)(2) of the Social Security Act (42 

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

20 (D) Health facilities operated by or pursu21 ant to a contract with the Indian Health Serv22 ice. 

23 (E) Community-based organizations, clin24 ics, hospitals, and other health facilities that 


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1 provide services to individuals at risk for or liv2 ing with HIV. 

3 (F) Nonprofit private entities providing 

4 comprehensive primary care to populations at 

5 risk of HIV, including faith-based and commu6 nity-based organizations. 

7 (2) USE OF FUNDS.—Any entity receiving fund8 ing under paragraph (1) shall use such funds for eli9 gible PrEP expenses. 

10 (d) ELIGIBLE PREP EXPENSES.— 

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

12 a list of expenses that qualify as eligible PrEP ex13 penses for purposes of this section. 

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

15 (A) any prescription drug approved by the 

16 Food and Drug Administration for the preven17 tion of HIV acquisition, laboratory and other 

18 diagnostic procedures associated with the use of 

19 such drugs, and clinical follow up and moni20 toring, including any related services rec21 ommended in current United States Public 

22 Health Service clinical practice guidelines, with23 out limitation; 

24 (B) outreach and public education activi25 ties directed toward populations overrepresented 


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1 in the domestic HIV epidemic that increase 

2 awareness about the existence of PrEP, provide 

3 education about access to and health care cov4 erage of PrEP, and counter stigma associated 

5 with the use of PrEP; and 

6 (C) outreach activities directed toward 

7 physicians and other providers that provide 

8 education about PrEP. 

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

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

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

12 make public on the internet website of Department of 

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

14 any grants provided to States, territories, and Indian 

15 Tribes for the establishment and support of pre-exposure 

16 prophylaxis programs under this section. 

17 (f) AUTHORIZATION OF APPROPRIATIONS.—There 

18 are authorized to be appropriated to carry out this section 

19 $60,000,000 for each of the first 5 fiscal years beginning 

20 after the date of the enactment of this section. 

21 SEC. 8. CLARIFICATION. 

22 This Act, including the amendments made by this 

23 Act, shall apply notwithstanding any other provision of 

24 law, including Public Law 103–141. 


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1 SEC. 9. PRIVATE RIGHT OF ACTION. 

2 Any person aggrieved by a violation of this Act, in3 cluding the amendments made by this Act, may commence 

4 a civil action in an appropriate United States District 

5 Court or other court of competent jurisdiction to obtain 

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

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

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

9 costs and reasonable attorney fees of the plaintiff. 

Æ 


kjohnson on DSK79L0C42 with BILLS