II 

117TH CONGRESS 

1ST SESSION S. 3295 

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

of HIV. 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 1, 2021 

Ms. SMITH (for herself and Ms. KLOBUCHAR) 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; SENSE OF CONGRESS. 

7 (a) FINDINGS.—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 2019, there were 36,398 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 2019, approximately 

6 66 percent of new HIV diagnoses were among gay 

7 and bisexual men, 42 percent of new HIV diagnoses 

8 were among Black people, and 22 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 about 99 percent. It reduces the 

20 risk of getting HIV from injection drug use by at 

21 least 74 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 23 percent, or nearly 285,000 individ2 uals, filled prescriptions for the drug in 2019. 

3 (6) PrEP usage is inconsistent across racial 

4 and gender lines. In 2019, only 8 percent of Black/ 

5 African American and 14 percent of Hispanic/Latinx 

6 persons who were eligible for PrEP were prescribed 

7 it, compared to 63 percent of white persons. Addi8 tionally, slightly less than 10 percent of women eligi9 ble for PrEP received a prescription in 2019. 

10 (7) There are currently 2 brand name drugs 

11 and 1 generic drug approved by the Food and Drug 

12 Administration for the use of PrEP on a daily basis. 

13 Other types of HIV prevention treatments, including 

14 a long-acting injectable, which is currently under 

15 FDA review, and long-acting oral pills, implants, 

16 and vaginal rings are in the research pipeline. These 

17 new innovations can increase widespread use of 

18 PrEP along with adherence, which can speed the 

19 Nation’s goal to end HIV and address inequities in 

20 health care. 

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 have to cover PrEP for such individuals 

7 without cost-sharing effective January 2021. 

8 (9) Joint guidance issued by the Department of 

9 Labor, the Department of Health and Human Serv10 ices, and the Department of the Treasury on July 

11 19, 2021, clarifies that ancillary services necessary 

12 to maintain the PrEP regime, including subsequent 

13 provider visits, clinical testing, and other services, is 

14 required to be covered by health insurers without 

15 cost-sharing. 

16 (10) Permanently expanding access to cost-free 

17 PrEP and ancillary services for all individuals, in18 cluding individuals who do not have health insur19 ance, through legislation, is a critical step towards 

20 eliminating HIV transmission. 

21 (11) Post-exposure prophylaxis (referred to in 

22 this section as ‘‘PEP’’) is a daily antiretroviral 

23 treatment which, when initiated promptly after a 

24 sexual or other exposure to blood or body fluids that 


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1 is associated with a high risk of HIV transmission, 

2 is highly effective at preventing HIV infection. 

3 (12) The Centers for Disease Control and Pre4 vention recommends PEP for an individual who has 

5 experienced a high-risk exposure incident, provided 

6 that the individual tests HIV-negative, initiates such 

7 treatment no later than 72 hours after exposure, 

8 and continues the treatment for 28 days. 

9 (13) Despite PEP’s proven effectiveness in pre10 venting HIV infection after high-risk sexual expo11 sures, awareness of PEP is low among individuals 

12 who would benefit from the treatment. Studies sug13 gest that awareness of PEP and of the importance 

14 of its prompt initiation is particularly low among 

15 young gay and bisexual men of color, transgender 

16 persons, and women of all gender identities. 

17 (14) Adequate knowledge of guidelines issued 

18 by the Centers for Disease Control and Prevention 

19 for assessing indications for PEP and for initiating 

20 and sustaining PEP are low among health care pro21 viders and staff. Because PEP is an emergency 

22 intervention, insufficient knowledge among providers 

23 and staff in hospital emergency rooms, urgent care 

24 centers, community health centers, and primary care 

25 physicians is of particular concern. 


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1 (15) Private and public health insurance plans 

2 and programs frequently impose requirements for 

3 coverage of PEP, including pre-authorization re4 quirements and requirements to obtain the medica5 tions through designated specialty pharmacies and 

6 mail-order programs that pose significant obstacles 

7 to timely initiation of treatment. 

8 (16) Insurance deductibles and co-payments for 

9 PEP medications create significant barriers to PEP 

10 utilization by many individuals who have experienced 

11 high-risk incidents. 

12 (b) SENSE OF CONGRESS.—It is the sense of Con13 gress that the Department of Labor, the Department of 

14 Health and Human Services, and the Department of the 

15 Treasury should ensure compliance with the requirements 

16 described in paragraphs (8) and (9) of subsection (a). 

17 SEC. 3. COVERAGE OF HIV TESTING AND PREVENTION 

18 SERVICES. 

19 (a) PRIVATE INSURANCE.— 

20 (1) IN GENERAL.—Section 2713(a)of the Public 

21 Health Service Act (42 U.S.C. 300gg–13(a)) is 

22 amended— 

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

24 and inserting a semicolon; 


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1 (B) in paragraph (3), by striking the pe2 riod and inserting a semicolon; 

3 (C) in paragraph (4), by striking the pe4 riod and inserting a semicolon; 

5 (D) in paragraph (5), by striking the pe6 riod and inserting ‘‘; and’’; and 

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

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

9 Food and Drug Administration for the prevention of 

10 HIV (other than a drug subject to preauthorization 

11 requirements consistent with section 2729A), admin12 istrative fees for such drugs, laboratory and other 

13 diagnostic procedures associated with the use of 

14 such drugs, and clinical follow up and monitoring, 

15 including any related services recommended in cur16 rent United States Public Health Service clinical 

17 practice guidelines, without limitation.’’. 

18 (2) PROHIBITION ON PREAUTHORIZATION RE19 QUIREMENTS.—Subpart II of part A of title XXVII 

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

21 11 et seq.) is amended by adding at the end the fol22 lowing: 


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1 ‘‘SEC. 2729A. 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 preauthorization requirements with re7 spect to coverage of the services described in section 

8 2713(a)(6), except that a plan or issuer may impose 

9 preauthorization requirements with respect to coverage of 

10 a particular drug approved under section 505(c) of the 

11 Federal Food, Drug, and Cosmetic Act or section 351(a) 

12 of this Act if such plan or issuer provides coverage without 

13 any preauthorization requirements for a drug that is ther14 apeutically equivalent.’’. 

15 (b) COVERAGE UNDER FEDERAL EMPLOYEES

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

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

18 following: 

19 ‘‘(c) Any health benefits plan offered under this chap20 ter shall include benefits for, and may not impose any 

21 cost-sharing requirements for, any prescription drug ap22 proved by the Food and Drug Administration for the pre23 vention of HIV, administrative fees for such drugs, labora24 tory and other diagnostic procedures associated with the 

25 use of such drugs, and clinical follow up and monitoring, 

26 including any related services recommended in current 


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1 United States Public Health Service clinical practice 

2 guidelines, without limitation.’’. 

3 (c) MEDICAID.— 

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

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

6 (A) in subsection (a)(4)— 

7 (i) by striking ‘‘; and (D)’’ and insert8 ing ‘‘; (D)’’; 

9 (ii) by striking ‘‘; and (E)’’ and in10 serting ‘‘; (E)’’; 

11 (iii) by striking ‘‘; and (F)’’ and in12 serting ‘‘; (F)’’; and 

13 (iv) by striking the semicolon at the 

14 end and inserting ‘‘; and (G) HIV preven15 tion services;’’; and 

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

17 subsection: 

18 ‘‘(jj) HIV PREVENTION SERVICES.—For purposes of 

19 subsection (a)(4)(G), the term ‘HIV prevention services’ 

20 means prescription drugs for the prevention of HIV acqui21 sition, administrative fees for such drugs, laboratory and 

22 other diagnostic procedures associated with the use of 

23 such drugs, and clinical follow up and monitoring, includ24 ing any related services recommended in current United 


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1 States Public Health Service clinical practice guidelines, 

2 without limitation.’’. 

3 (2) NO COST-SHARING.—Title XIX of the So4 cial Security Act (42 U.S.C. 1396 et seq.) is amend5 ed— 

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

7 prevention services described in section 

8 1905(a)(4)(G),’’ after ‘‘section 1905(a)(4)(C),’’ 

9 each place it appears; and 

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

11 at the end the following new clause: 

12 ‘‘(xii) HIV prevention services de13 scribed in section 1905(a)(4)(G).’’. 

14 (3) INCLUSION IN BENCHMARK COVERAGE.— 

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

16 U.S.C. 1396u–7(b)(7)) is amended— 

17 (A) in the paragraph header, by inserting 

18 ‘‘AND HIV PREVENTION SERVICES’’ after ‘‘SUP19 PLIES’’; and 

20 (B) by striking ‘‘includes for any individual 

21 described in section 1905(a)(4)(C), medical as22 sistance for family planning services and sup23 plies in accordance with such section’’ and in24 serting ‘‘includes medical assistance for HIV 

25 prevention services described in section 


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1 1905(a)(4)(G), and includes, for any individual 

2 described in section 1905(a)(4)(C), medical as3 sistance for family planning services and sup4 plies in accordance with such section’’. 

5 (d) CHIP.— 

6 (1) IN GENERAL.—Section 2103 of the Social 

7 Security Act (42 U.S.C. 1397cc) is amended— 

8 (A) in subsection (a), by striking ‘‘and 

9 (8)’’ and inserting ‘‘(8), (10), (11), and (12)’’; 

10 and 

11 (B) in subsection (c), by adding at the end 

12 the following new paragraph: 

13 ‘‘(12) HIV PREVENTION SERVICES.—Regard14 less of the type of coverage elected by a State under 

15 subsection (a), the child health assistance provided 

16 for a targeted low-income child, and, in the case of 

17 a State that elects to provide pregnancy-related as18 sistance pursuant to section 2112, the pregnancy-re19 lated assistance provided for a targeted low-income 

20 pregnant woman (as such terms are defined for pur21 poses of such section), shall include coverage of HIV 

22 prevention services (as defined in section 1905(jj)).’’. 

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

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

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1 scribed in subsection (c)(12),’’ before ‘‘or for preg2 nancy-related assistance’’. 

3 (3) EFFECTIVE DATE.— 

4 (A) IN GENERAL.—Subject to subpara5 graph (A), the amendments made by subsection 

6 (c) and this subsection shall take effect on Jan7 uary 1, 2023. 

8 (B) DELAY PERMITTED IF STATE LEGISLA9 TION REQUIRED.—In the case of a State plan 

10 approved under title XIX of the Social Security 

11 Act which the Secretary of Health and Human 

12 Services determines requires State legislation 

13 (other than legislation appropriating funds) in 

14 order for the plan to meet the additional re15 quirements imposed by this section, the State 

16 plan shall not be regarded as failing to comply 

17 with the requirements of such title solely on the 

18 basis of the failure of the plan to meet such ad19 ditional requirements before the 1st day of the 

20 1st calendar quarter beginning after the close 

21 of the 1st regular session of the State legisla22 ture that ends after the 1-year period beginning 

23 with the date of the enactment of this section. 

24 For purposes of the preceding sentence, in the 

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1 sion, each year of the session is deemed to be 

2 a separate regular session of the State legisla3 ture. 

4 (e) COVERAGE AND ELIMINATION OF COST-SHARING

5 UNDER MEDICARE.— 

6 (1) COVERAGE OF HIV PREVENTION SERVICES

7 UNDER PART B.— 

8 (A) COVERAGE.— 

9 (i) IN GENERAL.—Section 1861(s)(2) 

10 of the Social Security Act (42 U.S.C. 

11 1395x(s)(2)) is amended— 

12 (I) in subparagraph (GG), by 

13 striking ‘‘and’’ at the end; 

14 (II) in subparagraph (HH), by 

15 striking the period at the end and in16 serting ‘‘; and’’; and 

17 (III) by adding at the end the 

18 following new subparagraph: 

19 ‘‘(II) HIV prevention services (as defined in 

20 subsection (lll));’’. 

21 (ii) DEFINITION.—Section 1861 of 

22 the Social Security Act (42 U.S.C. 1395x) 

23 is amended by adding at the end the fol24 lowing new subsection: 


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1 ‘‘(lll) HIV PREVENTION SERVICES.—The term ‘HIV 

2 prevention services’ means— 

3 ‘‘(1) drugs or biologicals approved by the Food 

4 and Drug Administration for the prevention of HIV; 

5 ‘‘(2) administrative fees for such drugs; 

6 ‘‘(3) laboratory and other diagnostic procedures 

7 associated with the use of such drugs; and 

8 ‘‘(4) clinical follow up and monitoring, including 

9 any related services recommended in current United 

10 States Public Health Service clinical practice guide11 lines, without limitation.’’. 

12 (B) ELIMINATION OF COINSURANCE.—Sec13 tion 1833(a)(1) of the Social Security Act (42 

14 U.S.C. 1395l(a)(1)) is amended— 

15 (i) by striking ‘‘and (DD)’’ and in16 serting ‘‘(DD)’’; and 

17 (ii) by inserting before the semicolon 

18 at the end the following: ‘‘and (EE) with 

19 respect to HIV prevention services (as de20 fined in section 1861(lll)), the amount paid 

21 shall be 100 percent of (i) except as pro22 vided in clause (ii), the lesser of the actual 

23 charge for the service or the amount deter24 mined under the fee schedule that applies 

25 to such services under this part, and (ii) in 


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1 the case of such services that are covered 

2 OPD services (as defined in subsection 

3 (t)(1)(B)), the amount determined under 

4 subsection (t)’’. 

5 (C) EXEMPTION FROM PART B DEDUCT6 IBLE.—Section 1833(b) of the Social Security 

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

8 (i) in paragraph (11), by striking 

9 ‘‘and’’ at the end; and 

10 (ii) in paragraph (12), by striking the 

11 period at the end and inserting ‘‘, and (13) 

12 such deductible shall not apply with re13 spect to HIV prevention services (as de14 fined in section 1861(lll)).’’. 

15 (D) EFFECTIVE DATE.—The amendments 

16 made by this paragraph shall apply to items 

17 and services furnished on or after January 1, 

18 2023. 

19 (2) ELIMINATION OF COST-SHARING FOR

20 DRUGS FOR THE PREVENTION OF HIV UNDER PART

21 D.— 

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

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

24 102(b)) is amended— 


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

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

3 paragraph (8), the coverage’’; 

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

5 ‘‘and (D)’’ and inserting ‘‘and (D) and 

6 paragraph (8)’’; 

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

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

9 (iv) in paragraph (4)(A)(i), by strik10 ing ‘‘The coverage’’ and inserting ‘‘Subject 

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

12 (v) by adding at the end the following 

13 new paragraph: 

14 ‘‘(8) ELIMINATION OF COST-SHARING FOR

15 DRUGS FOR THE PREVENTION OF HIV.— 

16 ‘‘(A) IN GENERAL.—For plan year 2023 

17 and each subsequent plan year, there shall be 

18 no cost-sharing under this part (including 

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

20 drugs that are for the prevention of HIV. 

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

22 subparagraph (A), the elimination of cost-shar23 ing shall include the following: 


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1 ‘‘(i) NO APPLICATION OF DEDUCT2 IBLE.—The waiver of the deductible under 

3 paragraph (1). 

4 ‘‘(ii) NO APPLICATION OF COINSUR5 ANCE.—The waiver of coinsurance under 

6 paragraph (2). 

7 ‘‘(iii) NO APPLICATION OF INITIAL

8 COVERAGE LIMIT.—The initial coverage 

9 limit under paragraph (3) shall not apply. 

10 ‘‘(iv) NO COST-SHARING ABOVE AN11 NUAL OUT-OF-POCKET THRESHOLD.—The 

12 waiver of cost-sharing under paragraph 

13 (4).’’. 

14 (B) CONFORMING AMENDMENTS TO COST15 SHARING FOR LOW-INCOME INDIVIDUALS.—Sec16 tion 1860D–14(a) of the Social Security Act 

17 (42 U.S.C. 1395w–114(a)) is amended— 

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

19 preceding subparagraph (A), by striking 

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

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

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

23 preceding subparagraph (A), by striking 

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

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


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1 (f) COVERAGE OF HIV PREVENTION TREATMENT BY

2 DEPARTMENT OF VETERANS AFFAIRS.— 

3 (1) ELIMINATION OF MEDICATION COPAY4 MENTS.—Section 1722A(a) of title 38, United 

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

6 following new paragraph: 

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

8 for the prevention of HIV.’’. 

9 (2) ELIMINATION OF HOSPITAL CARE AND MED10 ICAL SERVICES COPAYMENTS.—Section 1710 of such 

11 title is amended— 

12 (A) in subsection (f)— 

13 (i) by redesignating paragraph (5) as 

14 paragraph (6); and 

15 (ii) by inserting after paragraph (4) 

16 the following new paragraph (5): 

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

18 under this subsection for any amounts for laboratory and 

19 other diagnostic procedures associated with the use of any 

20 prescription drug approved by the Food and Drug Admin21 istration for the prevention of HIV, administrative fees for 

22 such drugs, or for laboratory or other diagnostic proce23 dures associated with the use of such drugs, or clinical 

24 follow up and monitoring, including any related services 

25 recommended in current United States Public Health 


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1 Service clinical practice guidelines, without limitation.’’; 

2 and 

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

4 end the following new subparagraph: 

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

6 Food and Drug Administration for the prevention of 

7 HIV, administrative fees for such drugs, laboratory 

8 and other diagnostic procedures associated with the 

9 use of such drugs, and clinical follow up and moni10 toring, including any related services recommended 

11 in current United States Public Health Service clin12 ical practice guidelines, without limitation.’’. 

13 (3) INCLUSION AS PREVENTIVE HEALTH SERV14 ICE.—Section 1701(9) of such title is amended— 

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

16 and’’ and inserting a semicolon; 

17 (B) by redesignating subparagraph (L) as 

18 subparagraph (M); and 

19 (C) by inserting after subparagraph (K) 

20 the following new subparagraph (L): 

21 ‘‘(L) any prescription drug approved by 

22 the Food and Drug Administration for the pre23 vention of HIV, administrative fees for such 

24 drugs, laboratory and other diagnostic proce25 dures associated with the use of such drugs, 


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1 and clinical follow up and monitoring, including 

2 any related services recommended in current 

3 United States Public Health Service clinical 

4 practice guidelines, without limitation; and’’. 

5 (g) COVERAGE OF HIV PREVENTION TREATMENT BY

6 DEPARTMENT OF DEFENSE.— 

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

8 United States Code, is amended by inserting after 

9 section 1079c the following new section: 

10 ‘‘§ 1079d. Coverage of HIV prevention treatment 

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

12 ensure coverage under the TRICARE program of HIV 

13 prevention treatment described in subsection (b) for any 

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

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

16 HIV prevention treatment described in this subsection in17 cludes any prescription drug approved by the Food and 

18 Drug Administration for the prevention of HIV, adminis19 trative fees for such drugs, laboratory and other diagnostic 

20 procedures associated with the use of such drugs, and clin21 ical follow up and monitoring, including any related serv22 ices recommended in current United States Public Health 

23 Service clinical practice guidelines, without limitation. 

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

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1 vision of law, there is no cost-sharing requirement for HIV 

2 prevention treatment covered under this section.’’. 

3 (2) CLERICAL AMENDMENT.—The table of sec4 tions at the beginning of such chapter is amended 

5 by inserting after the item relating to section 1079c 

6 the following new item: 

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

7 (h) INDIAN HEALTH SERVICE TESTING, MONI8 TORING, AND PRESCRIPTION DRUGS FOR THE PREVEN9 TION OF HIV.—The Indian Health Care Improvement Act 

10 is amended by inserting after section 223 (25 U.S.C. 

11 1621v) the following: 

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

13 DRUGS FOR THE PREVENTION OF HIV. 

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

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

16 provide funding for any prescription drug approved by the 

17 Food and Drug Administration for the prevention of 

18 human immunodeficiency virus (commonly known as 

19 ‘HIV’), administrative fees for such a drug, laboratory and 

20 other diagnostic procedures associated with the use of 

21 such a drug, and clinical follow up and monitoring, includ22 ing any related services recommended in current United 

23 States Public Health Service clinical practice guidelines, 

24 without limitation. 


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

2 are authorized to be appropriated such sums as may be 

3 necessary to carry out this section.’’. 

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

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

6 with respect to plan years beginning on or after January 

7 1, 2023. 

8 SEC. 4. PROHIBITION ON DENIAL OF COVERAGE OR IN9 CREASE IN PREMIUMS OF LIFE, DISABILITY, 

10 OR LONG-TERM CARE INSURANCE FOR INDI11 VIDUALS TAKING MEDICATION FOR THE PRE12 VENTION OF HIV ACQUISITION. 

13 (a) PROHIBITION.—Notwithstanding any other provi14 sion of law, it shall be unlawful to— 

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

16 any life insurance policy, disability insurance policy, 

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

18 individual taking medication for the purpose of pre19 venting the acquisition of HIV; 

20 (2) preclude an individual from taking medica21 tion for the purpose of preventing the acquisition of 

22 HIV as a condition of receiving a life insurance pol23 icy, disability insurance policy, or long-term care in24 surance policy; 


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1 (3) consider whether an individual is taking 

2 medication for the purpose of preventing the acquisi3 tion of HIV in determining the premium rate for 

4 coverage of such individual under a life insurance 

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

6 insurance policy; or 

7 (4) otherwise discriminate in the offering, 

8 issuance, cancellation, amount of such coverage, 

9 price, or any other condition of a life insurance pol10 icy, disability insurance policy, or long-term care in11 surance policy for an individual, based solely and 

12 without any additional actuarial risks upon whether 

13 the individual is taking medication for the purpose 

14 of preventing the acquisition of HIV. 

15 (b) ENFORCEMENT.—A State insurance regulator 

16 may take such actions to enforce subsection (a) as are spe17 cifically authorized under the laws of such State. 

18 (c) DEFINITIONS.—In this section: 

19 (1) DISABILITY INSURANCE POLICY.—The term 

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

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

22 money in the event that an illness or injury resulting 

23 in a disability prevents such person from working. 

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

25 insurance policy’’ means a contract under which an 


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1 entity promises to pay a designated beneficiary a 

2 sum of money upon the death of the insured. 

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

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

5 a contract for which the only insurance protection 

6 provided under the contract is coverage of qualified 

7 long-term care services (as defined in section 

8 7702B(c) of the Internal Revenue Code of 1986). 

9 SEC. 5. PUBLIC EDUCATION CAMPAIGN. 

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

11 (42 U.S.C. 280g et seq.) is amended by adding at the end 

12 the following: 

13 ‘‘SEC. 399V–7. PRE-EXPOSURE PROPHYLAXIS AND POST-EX14 POSURE PROPHYLAXIS EDUCATION CAM15 PAIGNS. 

16 ‘‘(a) PUBLIC EDUCATION CAMPAIGN.— 

17 ‘‘(1) IN GENERAL.—The Secretary, acting 

18 through the Director of the Centers for Disease 

19 Control and Prevention, in consultation with the Di20 rector of the Office of Infectious Disease and HIV/ 

21 AIDS Policy, shall establish a public health cam22 paign for the purpose of educating the public on 

23 medication for the prevention of HIV acquisition. 

24 ‘‘(2) REQUIREMENTS.—In carrying out this 

25 subsection, the Secretary shall ensure cultural comVerDate Sep 11 2014 00:58 Dec 09, 2021 Jkt 029200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6201 E:\BILLS\S3295.IS S3295

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1 petency and efficacy within high-need communities 

2 in which PrEP or PEP are underutilized by devel3 oping the campaign in collaboration with organiza4 tions that are indigenous to communities that are 

5 overrepresented in the domestic HIV epidemic, in6 cluding communities of color and the lesbian, gay, 

7 bisexual, transgender, and queer community. The 

8 Secretary shall ensure that the campaign is designed 

9 to increase awareness of the safety and effectiveness 

10 of PrEP and PEP, the recommended clinical prac11 tices for providing PrEP-related and PEP-related 

12 clinical care, and the local availability of PrEP and 

13 PEP providers, and to counter stigma associated 

14 with the use of PrEP and PEP. 

15 ‘‘(3) EVALUATION OF PROGRAM.—The Sec16 retary shall develop measures to evaluate the effec17 tiveness of activities conducted under this subsection 

18 that are aimed at reducing disparities in access to 

19 PrEP and PEP and supporting the local commu20 nity. Such measures shall evaluate community out21 reach activities, language services, workforce cultural 

22 competence, and other areas as determined by the 

23 Secretary. 

24 ‘‘(b) PROVIDER EDUCATION CAMPAIGN.— 


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1 ‘‘(1) IN GENERAL.—The Secretary, acting 

2 through the Director of the Centers for Disease 

3 Control and Prevention and the Administration of 

4 the Health Resources Services Administration and 

5 the Office of Infectious Disease and HIV/AIDS Pol6 icy, shall establish a provider campaign for the pur7 pose of educating prescribers and other associated 

8 health professionals on medication for the prevention 

9 of HIV acquisition. 

10 ‘‘(2) REQUIREMENTS.—In carrying out this 

11 subsection, the Secretary shall increase awareness 

12 and readiness among health care providers to offer 

13 PrEP or PEP, as appropriate, with a focus on areas 

14 of high-need communities in which PrEP or PEP is 

15 underutilized by developing an educational campaign 

16 with input from health care providers and organiza17 tions that are indigenous to communities that are 

18 overrepresented in the domestic HIV epidemic, in19 cluding communities of color and the lesbian, gay, 

20 bisexual, transgender, and queer community. The 

21 Secretary shall ensure that the campaign is designed 

22 to increase awareness of the safety and effectiveness 

23 of PrEP and PEP, the recommended clinical prac24 tices for providing PrEP-related and PEP-related 

25 clinical care, cultural competency among PrEP and 


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1 PEP prescribers, and to counter stigma associated 

2 with the use of PrEP and PEP. 

3 ‘‘(3) EVALUATION OF PROGRAM.—The Sec4 retary shall develop measures to evaluate the effec5 tiveness of activities conducted under this subsection 

6 that are aimed at increasing the number of health 

7 care professionals offering PrEP and PEP and re8 ducing disparities in access to PrEP and PEP. Such 

9 measures shall evaluate availability of PrEP and 

10 PEP services, education and outreach activities, lan11 guage services, workforce cultural competence, and 

12 other areas as determined by the Secretary. 

13 ‘‘(c) DEFINITIONS.—In this section and section 

14 399V–8— 

15 ‘‘(1) the term ‘PEP’ means any drug or com16 bination of drugs approved by the Food and Drug 

17 Administration for preventing HIV infection after a 

18 sexual or other exposure associated with a high risk 

19 of HIV transmission; and 

20 ‘‘(2) the term ‘PrEP’ means any drug approved 

21 by the Food and Drug Administration for the pur22 pose of pre-exposure prophylaxis with respect to 

23 HIV. 

24 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—To 

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1 priated such sums as may be necessary for each of fiscal 

2 years 2023 through 2028.’’. 

3 SEC. 6. PATIENT CONFIDENTIALITY. 

4 The Secretary of Health and Human Services shall 

5 amend the regulations promulgated under section 264(c) 

6 of the Health Insurance Portability and Accountability 

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

8 ensure that individuals are able to access the benefits de9 scribed in section 2713(a)(6) under a family plan without 

10 any other individual enrolled in such family plan, including 

11 a primary subscriber of or policyholder, being informed of 

12 such use of such benefits. 

13 SEC. 7. PRE-EXPOSURE PROPHYLAXIS AND POST-EXPO14 SURE PROPHYLAXIS FUNDING. 

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

16 (42 U.S.C. 280g et seq.), as amended by section 5, is fur17 ther amended by adding at the end the following: 

18 ‘‘SEC. 399V–8. PRE-EXPOSURE PROPHYLAXIS AND POST-EX19 POSURE PROPHYLAXIS FUNDING. 

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

21 date of the enactment of the PrEP Access and Coverage 

22 Act, the Secretary shall establish a program that awards 

23 grants to States, territories, Indian Tribes, and directly 

24 eligible entities for the establishment and support of pre25 exposure prophylaxis (referred to in this section as 


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1 ‘PrEP’) and post-exposure prophylaxis (referred to in this 

2 section as ‘PEP’) programs. 

3 ‘‘(b) APPLICATIONS.—To be eligible to receive a 

4 grant under subsection (a), a State, territory, Indian 

5 Tribe, or directly eligible entity shall— 

6 ‘‘(1) submit an application to the Secretary at 

7 such time, in such manner, and containing such in8 formation as the Secretary may require, including a 

9 plan describing how any funds awarded will be used 

10 to increase access to PrEP for uninsured and under11 insured individuals and reduce disparities in access 

12 to PrEP and PEP for uninsured and underinsured 

13 individuals and reduce disparities in access to PrEP 

14 and PEP; and 

15 ‘‘(2) appoint a PrEP and PEP grant adminis16 trator to manage the program. 

17 ‘‘(c) DIRECTLY ELIGIBLE ENTITY.—For purposes of 

18 this section, the term ‘directly eligible entity’— 

19 ‘‘(1) means a Federally qualified health center 

20 or other nonprofit entity engaged in providing PrEP 

21 and PEP information and services; and 

22 ‘‘(2) may include— 

23 ‘‘(A) a Federally qualified health center 

24 (as defined in section 1861(aa)(4) of the Social 

25 Security Act (42 U.S.C. 1395x(aa)(4))); 


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1 ‘‘(B) a family planning grantee (other than 

2 States) funded under section 1001 of the Public 

3 Health Service Act (42 U.S.C. 300); 

4 ‘‘(C) a rural health clinic (as defined in 

5 section 1861(aa)(2) of the Social Security Act 

6 (42 U.S.C. 1395x(aa)(2))); 

7 ‘‘(D) a health facility operated by or pur8 suant to a contract with the Indian Health 

9 Service; 

10 ‘‘(E) a community-based organization, clin11 ic, hospital, or other health facility that pro12 vides services to individuals at risk for or living 

13 with HIV; and 

14 ‘‘(F) a nonprofit private entity providing 

15 comprehensive primary care to populations at 

16 risk of HIV, including faith-based and commu17 nity-based organizations. 

18 ‘‘(d) AWARDS.—In determining whether to award a 

19 grant, and the grant amount for each grant awarded, the 

20 Secretary shall consider the grant application and the 

21 need for PrEP and PEP services in the area, the number 

22 of uninsured and underinsured individuals in the area, and 

23 how the State, territory, or Indian Tribe coordinates 

24 PrEP and PEP activities with the directly funded entity, 


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1 if the State, territory, or Indian Tribe applies for the 

2 funds. 

3 ‘‘(e) USE OF FUNDS.— 

4 ‘‘(1) IN GENERAL.—Any State, territory, Indian 

5 Tribe, or directly eligible entity that is awarded 

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

7 eligible PrEP and PEP expenses. 

8 ‘‘(2) ELIGIBLE PREP EXPENSES.—The Sec9 retary shall publish a list of expenses that qualify as 

10 eligible PrEP and PEP expenses for purposes of this 

11 section, which shall include— 

12 ‘‘(A) any prescription drug approved by 

13 the Food and Drug Administration for the pre14 vention of HIV, administrative fees for such 

15 drugs, laboratory and other diagnostic proce16 dures associated with the use of such drugs, 

17 and clinical follow up and monitoring, including 

18 any related services recommended in current 

19 United States Public Health Service clinical 

20 practice guidelines, without limitation; 

21 ‘‘(B) outreach and public education activi22 ties directed toward populations overrepresented 

23 in the domestic HIV epidemic that increase 

24 awareness about the existence of PrEP and 

25 PEP, provide education about access to and 


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1 health care coverage of PrEP and PEP, PrEP 

2 and PEP adherence programs, and counter 

3 stigma associated with the use of PrEP and 

4 PEP; and 

5 ‘‘(C) outreach activities directed toward 

6 physicians and other providers that provide 

7 education about PrEP and PEP. 

8 ‘‘(f) REPORT TO CONGRESS.—The Secretary shall, in 

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

10 of the enactment of the PrEP Access and Coverage Act, 

11 submit to Congress, and make public on the internet 

12 website of Department of Health and Human Services, a 

13 report on the impact of any grants provided to States, ter14 ritories, and Indian Tribes and directly eligible entities for 

15 the establishment and support of pre-exposure prophylaxis 

16 programs under this section. 

17 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To 

18 carry out this section, there are authorized to be appro19 priated such sums as may be necessary for each of fiscal 

20 years 2023 through 2028.’’. 

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 


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