I 

117TH CONGRESS 

1ST SESSION H. R. 6117 

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

of HIV. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 1, 2021 

Mr. SCHIFF (for himself, Mr. NADLER, Ms. TITUS, Mr. COHEN, Ms. LEE of 

California, Ms. PORTER, Ms. SPEIER, Mr. POCAN, Mrs. WATSON COLEMAN, Mr. WELCH, Mr. TONKO, Mr. CASTEN, Mr. TAKANO, Mr. RUSH, 

Ms. SEWELL, Mr. KHANNA, Ms. PRESSLEY, Mr. QUIGLEY, Mr. 

MOULTON, Mr. SOTO, Ms. MANNING, Ms. PINGREE, Mr. PAYNE, Ms. 

JACKSON LEE, Mr. LYNCH, Mr. CICILLINE, Mr. TORRES of New York, 

Ms. VELA ́ZQUEZ, Mr. JONES, Ms. TLAIB, Mr. SWALWELL, Ms. NORTON, 

and Mr. BLUMENAUER) introduced the following bill; which was referred 

to the Committee on Energy and Commerce, and in addition to the Committees on Oversight and Reform, Ways and Means, Veterans’ Affairs, 

Armed Services, Natural Resources, 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, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘PrEP Access and Cov3 erage Act’’. 

4 SEC. 2. FINDINGS; SENSE OF CONGRESS. 

5 (a) FINDINGS.—Congress finds as follows: 

6 (1) The Centers for Disease Control and Pre7 vention estimates that approximately 1,100,000 peo8 ple in the United States are living with HIV. 

9 (2) In 2019, there were 36,398 new diagnoses 

10 of HIV in the United States. 

11 (3) HIV disproportionately impacts gay and bi12 sexual men, transgender women, and, in particular, 

13 people of color. For example, in 2019, approximately 

14 66 percent of new HIV diagnoses were among gay 

15 and bisexual men, 42 percent of new HIV diagnoses 

16 were among Black people, and 22 percent of new 

17 HIV diagnoses were among Latinx people. Recent 

18 studies suggest that transgender women are up to 

19 49 times more likely to be diagnosed with HIV than 

20 the general population. Members of communities at 

21 the intersections of these groups are most heavily 

22 impacted. 

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

24 section as ‘‘PrEP’’) is a daily antiretroviral medica25 tion that helps prevent individuals from acquiring 

26 HIV. Daily PrEP use reduces the risk of getting 


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1 HIV from sex by about 99 percent. It reduces the 

2 risk of getting HIV from injection drug use by at 

3 least 74 percent. 

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

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

6 people in the United States who could benefit from 

7 PrEP, only 23 percent, or nearly 285,000 individ8 uals, filled prescriptions for the drug in 2019. 

9 (6) PrEP usage is inconsistent across racial 

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

11 African American and 14 percent of Hispanic/Latinx 

12 persons who were eligible for PrEP were prescribed 

13 it, compared to 63 percent of White persons. Addi14 tionally, slightly less than 10 percent of women eligi15 ble for PrEP received a prescription in 2019. 

16 (7) There are currently 2 brand name drugs 

17 and 1 generic drug approved by the Food and Drug 

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

19 Other types of HIV prevention treatments, including 

20 a long-acting injectable, which is currently under 

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

22 and vaginal rings are in the research pipeline. These 

23 new innovations can increase widespread use of 

24 PrEP along with adherence, which can speed the 


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

2 health care. 

3 (8) Section 2713 of the Public Health Service 

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

5 health insurance plans to cover preventive services 

6 without cost-sharing, including such services with a 

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

8 United States Preventive Services Task Force. On 

9 June 11, 2019, the United States Preventive Serv10 ices Task Force issued a final recommendation giv11 ing an ‘‘A’’ grade for PrEP for individuals at high 

12 risk of HIV; non-grandfathered private health insur13 ance plans have to cover PrEP for such individuals 

14 without cost-sharing effective January 2021. 

15 (9) Joint guidance issued by the Department of 

16 Labor, the Department of Health and Human Serv17 ices, and the Department of the Treasury on July 

18 19, 2021, clarifies that ancillary services necessary 

19 to maintain the PrEP regime, including subsequent 

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

21 required to be covered by health insurers without 

22 cost-sharing. 

23 (10) Permanently expanding access to cost-free 

24 PrEP and ancillary services for all individuals, in25 cluding individuals who do not have health insurVerDate Sep 11 2014 23:23 Dec 10, 2021 Jkt 029200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H6117.IH H6117

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1 ance, through legislation, is a critical step towards 

2 eliminating HIV transmission. 

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

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

5 treatment which, when initiated promptly after a 

6 sexual or other exposure to blood or body fluids that 

7 is associated with a high risk of HIV transmission, 

8 is highly effective at preventing HIV infection. 

9 (12) The Centers for Disease Control and Pre10 vention recommends PEP for an individual who has 

11 experienced a high-risk exposure incident, provided 

12 that the individual tests HIV-negative, initiates such 

13 treatment no later than 72 hours after exposure, 

14 and continues the treatment for 28 days. 

15 (13) Despite PEP’s proven effectiveness in pre16 venting HIV infection after high-risk sexual expo17 sures, awareness of PEP is low among individuals 

18 who would benefit from the treatment. Studies sug19 gest that awareness of PEP and of the importance 

20 of its prompt initiation is particularly low among 

21 young gay and bisexual men of color, transgender 

22 persons, and women of all gender identities. 

23 (14) Adequate knowledge of guidelines issued 

24 by the Centers for Disease Control and Prevention 

25 for assessing indications for PEP and for initiating 


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1 and sustaining PEP are low among health care pro2 viders and staff. Because PEP is an emergency 

3 intervention, insufficient knowledge among providers 

4 and staff in hospital emergency rooms, urgent care 

5 centers, community health centers, and primary care 

6 physicians is of particular concern. 

7 (15) Private and public health insurance plans 

8 and programs frequently impose requirements for 

9 coverage of PEP, including pre-authorization re10 quirements and requirements to obtain the medica11 tions through designated specialty pharmacies and 

12 mail-order programs that pose significant obstacles 

13 to timely initiation of treatment. 

14 (16) Insurance deductibles and co-payments for 

15 PEP medications create significant barriers to PEP 

16 utilization by many individuals who have experienced 

17 high-risk incidents. 

18 (b) SENSE OF CONGRESS.—It is the sense of Con19 gress that the Department of Labor, the Department of 

20 Health and Human Services, and the Department of the 

21 Treasury should ensure compliance with the requirements 

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

23 SEC. 3. COVERAGE OF HIV TESTING AND PREVENTION 

24 SERVICES. 

25 (a) PRIVATE INSURANCE.— 


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

2 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 (other than a drug subject to preauthorization 

16 requirements consistent with section 2729A), admin17 istrative fees for such drugs, laboratory and other 

18 diagnostic procedures associated with the use of 

19 such drugs, and clinical follow up and monitoring, 

20 including any related services recommended in cur21 rent United States Public Health Service clinical 

22 practice guidelines, without limitation.’’. 

23 (2) PROHIBITION ON PREAUTHORIZATION RE24 QUIREMENTS.—Subpart II of part A of title XXVII 

25 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. 2729A. 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 preauthorization requirements with re9 spect to coverage of the services described in section 

10 2713(a)(6), except that a plan or issuer may impose 

11 preauthorization requirements with respect to coverage of 

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

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

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

15 any preauthorization requirements for a drug that is ther16 apeutically equivalent.’’. 

17 (b) COVERAGE UNDER FEDERAL EMPLOYEES

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

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

20 following: 

21 ‘‘(c) Any health benefits plan offered under this chap22 ter shall include benefits for, and may not impose any cost 

23 sharing requirements for, any prescription drug approved 

24 by the Food and Drug Administration for the prevention 

25 of HIV, administrative fees for such drugs, laboratory and 


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1 other diagnostic procedures associated with the use of 

2 such drugs, and clinical follow up and monitoring, includ3 ing any related services recommended in current United 

4 States Public Health Service clinical practice guidelines, 

5 without limitation.’’. 

6 (c) MEDICAID.— 

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

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

9 (A) in subsection (a)(4)— 

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

12 (ii) by striking ‘‘; and (E)’’ and in13 serting ‘‘; (E)’’; 

14 (iii) by striking ‘‘; and (F)’’ and in15 serting ‘‘; (F)’’; and 

16 (iv) by striking the semicolon at the 

17 end and inserting ‘‘; and (G) HIV preven18 tion services;’’; and 

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

20 subsection: 

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

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

23 means prescription drugs for the prevention of HIV acqui24 sition, administrative fees for such drugs, laboratory and 

25 other diagnostic procedures associated with the use of 


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1 such drugs, and clinical follow up and monitoring, includ2 ing any related services recommended in current United 

3 States Public Health Service clinical practice guidelines, 

4 without limitation.’’. 

5 (2) NO COST-SHARING.—Title XIX of the So6 cial Security Act (42 U.S.C. 1396 et seq.) is amend7 ed— 

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

9 prevention services described in section 

10 1905(a)(4)(G),’’ after ‘‘section 1905(a)(4)(C),’’ 

11 each place it appears; and 

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

13 at the end the following new clause: 

14 ‘‘(xii) HIV prevention services de15 scribed in section 1905(a)(4)(G).’’. 

16 (3) INCLUSION IN BENCHMARK COVERAGE.— 

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

18 U.S.C. 1396u–7(b)(7)) is amended— 

19 (A) in the paragraph header, by inserting 

20 ‘‘AND HIV PREVENTION SERVICES’’ after ‘‘SUP21 PLIES’’; and 

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

23 described in section 1905(a)(4)(C), medical as24 sistance for family planning services and sup25 plies in accordance with such section’’ and inVerDate Sep 11 2014 23:23 Dec 10, 2021 Jkt 029200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H6117.IH H6117

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1 serting ‘‘includes medical assistance for HIV 

2 prevention services described in section 

3 1905(a)(4)(G), and includes, for any individual 

4 described in section 1905(a)(4)(C), medical as5 sistance for family planning services and sup6 plies in accordance with such section’’. 

7 (d) CHIP.— 

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

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

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

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

12 and 

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

14 the following new paragraph: 

15 ‘‘(12) HIV PREVENTION SERVICES.—Regard16 less of the type of coverage elected by a State under 

17 subsection (a), the child health assistance provided 

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

19 a State that elects to provide pregnancy-related as20 sistance pursuant to section 2112, the pregnancy-re21 lated assistance provided for a targeted low-income 

22 pregnant woman (as such terms are defined for pur23 poses of such section), shall include coverage of HIV 

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


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

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

3 amended by inserting ‘‘HIV prevention services de4 scribed in subsection (c)(12),’’ before ‘‘or for preg5 nancy-related assistance’’. 

6 (3) EFFECTIVE DATE.— 

7 (A) IN GENERAL.—Subject to subpara8 graph (A), the amendments made by subsection 

9 (c) and this subsection shall take effect on Jan10 uary 1, 2023. 

11 (B) DELAY PERMITTED IF STATE LEGISLA12 TION REQUIRED.—In the case of a State plan 

13 approved under title XIX of the Social Security 

14 Act which the Secretary of Health and Human 

15 Services determines requires State legislation 

16 (other than legislation appropriating funds) in 

17 order for the plan to meet the additional re18 quirements imposed by this section, the State 

19 plan shall not be regarded as failing to comply 

20 with the requirements of such title solely on the 

21 basis of the failure of the plan to meet such ad22 ditional requirements before the 1st day of the 

23 1st calendar quarter beginning after the close 

24 of the 1st regular session of the State legisla25 ture that ends after the 1-year period beginning 


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1 with the date of the enactment of this section. 

2 For purposes of the preceding sentence, in the 

3 case of a State that has a 2-year legislative ses4 sion, each year of the session is deemed to be 

5 a separate regular session of the State legisla6 ture. 

7 (e) COVERAGE AND ELIMINATION OF COST-SHARING

8 UNDER MEDICARE.— 

9 (1) COVERAGE OF HIV PREVENTION SERVICES

10 UNDER PART B.— 

11 (A) COVERAGE.— 

12 (i) IN GENERAL.—Section 1861(s)(2) 

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

14 1395x(s)(2)) is amended— 

15 (I) in subparagraph (GG), by 

16 striking ‘‘and’’ at the end; 

17 (II) in subparagraph (HH), by 

18 striking the period at the end and in19 serting ‘‘; and’’; and 

20 (III) by adding at the end the 

21 following new subparagraph: 

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

23 subsection (lll));’’. 

24 (ii) DEFINITION.—Section 1861 of 

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


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1 is amended by adding at the end the fol2 lowing new subsection: 

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

4 prevention services’ means— 

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

6 and Drug Administration for the prevention of HIV; 

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

8 ‘‘(3) laboratory and other diagnostic procedures 

9 associated with the use of such drugs; and 

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

11 any related services recommended in current United 

12 States Public Health Service clinical practice guide13 lines, without limitation.’’. 

14 (B) ELIMINATION OF COINSURANCE.—Sec15 tion 1833(a)(1) of the Social Security Act (42 

16 U.S.C. 1395l(a)(1)) is amended— 

17 (i) by striking ‘‘and (DD)’’ and in18 serting ‘‘(DD)’’; and 

19 (ii) by inserting before the semicolon 

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

21 respect to HIV prevention services (as de22 fined in section 1861(lll)), the amount paid 

23 shall be 100 percent of (i) except as pro24 vided in clause (ii), the lesser of the actual 

25 charge for the service or the amount deterVerDate Sep 11 2014 23:23 Dec 10, 2021 Jkt 029200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\H6117.IH H6117

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1 mined under the fee schedule that applies 

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

3 the case of such services that are covered 

4 OPD services (as defined in subsection 

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

6 subsection (t)’’. 

7 (C) EXEMPTION FROM PART B DEDUCT8 IBLE.—Section 1833(b) of the Social Security 

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

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

11 ‘‘and’’ at the end; and 

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

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

14 such deductible shall not apply with re15 spect to HIV prevention services (as de16 fined in section 1861(lll).’’. 

17 (D) EFFECTIVE DATE.—The amendments 

18 made by this paragraph shall apply to items 

19 and services furnished on or after January 1, 

20 2023. 

21 (2) ELIMINATION OF COST-SHARING FOR

22 DRUGS FOR THE PREVENTION OF HIV UNDER PART

23 D.— 


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

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

3 102(b)) is amended— 

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

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

6 paragraph (8), the coverage’’; 

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

8 ‘‘and (D)’’ and inserting ‘‘and (D) and 

9 paragraph (8)’’; 

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

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

12 (iv) in paragraph (4)(A)(i), by strik13 ing ‘‘The coverage’’ and inserting ‘‘Subject 

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

15 (v) by adding at the end the following 

16 new paragraph: 

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

18 DRUGS FOR THE PREVENTION OF HIV.— 

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

20 and each subsequent plan year, there shall be 

21 no cost-sharing under this part (including 

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

23 drugs that are for the prevention of HIV. 


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

2 subparagraph (A), the elimination of cost-shar3 ing shall include the following: 

4 ‘‘(i) NO APPLICATION OF DEDUCT5 IBLE.—The waiver of the deductible under 

6 paragraph (1). 

7 ‘‘(ii) NO APPLICATION OF COINSUR8 ANCE.—The waiver of coinsurance under 

9 paragraph (2). 

10 ‘‘(iii) NO APPLICATION OF INITIAL

11 COVERAGE LIMIT.—The initial coverage 

12 limit under paragraph (3) shall not apply. 

13 ‘‘(iv) NO COST SHARING ABOVE AN14 NUAL OUT-OF-POCKET THRESHOLD.—The 

15 waiver of cost sharing under paragraph 

16 (4).’’. 

17 (B) CONFORMING AMENDMENTS TO COST18 SHARING FOR LOW-INCOME INDIVIDUALS.—Sec19 tion 1860D–14(a) of the Social Security Act 

20 (42 U.S.C. 1395w–114(a)) is amended— 

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

22 preceding subparagraph (A), by striking 

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

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


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

2 preceding subparagraph (A), by striking 

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

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

5 (f) COVERAGE OF HIV PREVENTION TREATMENT BY

6 DEPARTMENT OF VETERANS AFFAIRS.— 

7 (1) ELIMINATION OF MEDICATION COPAY8 MENTS.—Section 1722A(a) of title 38, United 

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

10 following new paragraph: 

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

12 for the prevention of HIV.’’. 

13 (2) ELIMINATION OF HOSPITAL CARE AND MED14 ICAL SERVICES COPAYMENTS.—Section 1710 of such 

15 title is amended— 

16 (A) in subsection (f)— 

17 (i) by redesignating paragraph (5) as 

18 paragraph (6); and 

19 (ii) by inserting after paragraph (4) 

20 the following new paragraph (5): 

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

22 under this subsection for any amounts for laboratory and 

23 other diagnostic procedures associated with the use of any 

24 prescription drug approved by the Food and Drug Admin25 istration for the prevention of HIV, administrative fees for 


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1 such drugs, or for laboratory or other diagnostic proce2 dures associated with the use of such drugs, or clinical 

3 follow up and monitoring, including any related services 

4 recommended in current United States Public Health 

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

6 and 

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

8 end the following new subparagraph: 

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

10 Food and Drug Administration for the prevention of 

11 HIV, administrative fees for such drugs, laboratory 

12 and other diagnostic procedures associated with the 

13 use of such drugs, and clinical follow up and moni14 toring, including any related services recommended 

15 in current United States Public Health Service clin16 ical practice guidelines, without limitation.’’. 

17 (3) INCLUSION AS PREVENTIVE HEALTH SERV18 ICE.—Section 1701(9) of such title is amended— 

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

20 and’’ and inserting a semicolon; 

21 (B) by redesignating subparagraph (L) as 

22 subparagraph (M); and 

23 (C) by inserting after subparagraph (K) 

24 the following new subparagraph (L): 


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1 ‘‘(L) any prescription drug approved by 

2 the Food and Drug Administration for the pre3 vention of HIV, administrative fees for such 

4 drugs, laboratory and other diagnostic proce5 dures associated with the use of such drugs, 

6 and clinical follow up and monitoring, including 

7 any related services recommended in current 

8 United States Public Health Service clinical 

9 practice guidelines, without limitation; and’’. 

10 (g) COVERAGE OF HIV PREVENTION TREATMENT BY

11 DEPARTMENT OF DEFENSE.— 

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

13 United States Code, is amended by inserting after 

14 section 1079c the following new section: 

15 ‘‘§ 1079d. Coverage of HIV prevention treatment 

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

17 ensure coverage under the TRICARE program of HIV 

18 prevention treatment described in subsection (b) for any 

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

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

21 HIV prevention treatment described in this subsection in22 cludes any prescription drug approved by the Food and 

23 Drug Administration for the prevention of HIV, adminis24 trative fees for such drugs, laboratory and other diagnostic 

25 procedures associated with the use of such drugs, and clinVerDate Sep 11 2014 23:23 Dec 10, 2021 Jkt 029200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\H6117.IH H6117

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1 ical follow up and monitoring, including any related serv2 ices recommended in current United States Public Health 

3 Service clinical practice guidelines, without limitation. 

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

5 1075, 1075a, or 1074g(a)(6) of this title or any other pro6 vision of law, there is no cost-sharing requirement for HIV 

7 prevention treatment covered under this section.’’. 

8 (2) CLERICAL AMENDMENT.—The table of sec9 tions at the beginning of such chapter is amended 

10 by inserting after the item relating to section 1079c 

11 the following new item: 

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

12 (h) INDIAN HEALTH SERVICE TESTING, MONI13 TORING, AND PRESCRIPTION DRUGS FOR THE PREVEN14 TION OF HIV.—The Indian Health Care Improvement Act 

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

16 1621v) the following: 

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

18 DRUGS FOR THE PREVENTION OF HIV. 

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

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

21 provide funding for any prescription drug approved by the 

22 Food and Drug Administration for the prevention of 

23 human immunodeficiency virus (commonly known as 

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

25 other diagnostic procedures associated with the use of 


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1 such a drug, and clinical follow up and monitoring, includ2 ing any related services recommended in current United 

3 States Public Health Service clinical practice guidelines, 

4 without limitation. 

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

6 are authorized to be appropriated such sums as may be 

7 necessary to carry out this section.’’. 

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

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

10 with respect to plan years beginning on or after January 

11 1, 2023. 

12 SEC. 4. PROHIBITION ON DENIAL OF COVERAGE OR IN13 CREASE IN PREMIUMS OF LIFE, DISABILITY, 

14 OR LONG-TERM CARE INSURANCE FOR INDI15 VIDUALS TAKING MEDICATION FOR THE PRE16 VENTION OF HIV ACQUISITION. 

17 (a) PROHIBITION.—Notwithstanding any other provi18 sion of law, it shall be unlawful to— 

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

20 any life insurance policy, disability insurance policy, 

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

22 individual taking medication for the purpose of pre23 venting the acquisition of HIV; 

24 (2) preclude an individual from taking medica25 tion for the purpose of preventing the acquisition of 


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1 HIV as a condition of receiving a life insurance pol2 icy, disability insurance policy, or long-term care in3 surance policy; 

4 (3) consider whether an individual is taking 

5 medication for the purpose of preventing the acquisi6 tion of HIV in determining the premium rate for 

7 coverage of such individual under a life insurance 

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

9 insurance policy; or 

10 (4) otherwise discriminate in the offering, 

11 issuance, cancellation, amount of such coverage, 

12 price, or any other condition of a life insurance pol13 icy, disability insurance policy, or long-term care in14 surance policy for an individual, based solely and 

15 without any additional actuarial risks upon whether 

16 the individual is taking medication for the purpose 

17 of preventing the acquisition of HIV. 

18 (b) ENFORCEMENT.—A State insurance regulator 

19 may take such actions to enforce subsection (a) as are spe20 cifically authorized under the laws of such State. 

21 (c) DEFINITIONS.—In this section: 

22 (1) DISABILITY INSURANCE POLICY.—The term 

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

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


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1 money in the event that an illness or injury resulting 

2 in a disability prevents such person from working. 

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

4 insurance policy’’ means a contract under which an 

5 entity promises to pay a designated beneficiary a 

6 sum of money upon the death of the insured. 

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

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

9 a contract for which the only insurance protection 

10 provided under the contract is coverage of qualified 

11 long-term care services (as defined in section 

12 7702B(c) of the Internal Revenue Code of 1986). 

13 SEC. 5. PUBLIC EDUCATION CAMPAIGN. 

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

15 (42 U.S.C. 280g et seq.) is amended by adding at the end 

16 the following: 

17 ‘‘SEC. 399V–7. PRE-EXPOSURE PROPHYLAXIS AND POST-EX18 POSURE PROPHYLAXIS EDUCATION CAM19 PAIGNS. 

20 ‘‘(a) PUBLIC EDUCATION CAMPAIGN.— 

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

22 through the Director of the Centers for Disease 

23 Control and Prevention, in consultation with the Di24 rector of the Office of Infectious Disease and HIV/ 

25 AIDS Policy, shall establish a public health camVerDate Sep 11 2014 23:23 Dec 10, 2021 Jkt 029200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6201 E:\BILLS\H6117.IH H6117

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1 paign for the purpose of educating the public on 

2 medication for the prevention of HIV acquisition. 

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

4 subsection, the Secretary shall ensure cultural com5 petency and efficacy within high-need communities 

6 in which PrEP or PEP are underutilized by devel7 oping the campaign in collaboration with organiza8 tions that are indigenous to communities that are 

9 overrepresented in the domestic HIV epidemic, in10 cluding communities of color and the lesbian, gay, 

11 bisexual, transgender, and queer community. The 

12 Secretary shall ensure that the campaign is designed 

13 to increase awareness of the safety and effectiveness 

14 of PrEP and PEP, the recommended clinical prac15 tices for providing PrEP-related and PEP-related 

16 clinical care, and the local availability of PrEP and 

17 PEP providers, and to counter stigma associated 

18 with the use of PrEP and PEP. 

19 ‘‘(3) EVALUATION OF PROGRAM.—The Sec20 retary shall develop measures to evaluate the effec21 tiveness of activities conducted under this subsection 

22 that are aimed at reducing disparities in access to 

23 PrEP and PEP and supporting the local commu24 nity. Such measures shall evaluate community out25 reach activities, language services, workforce cultural 


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1 competence, and other areas as determined by the 

2 Secretary. 

3 ‘‘(b) PROVIDER EDUCATION CAMPAIGN.— 

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

5 through the Director of the Centers for Disease 

6 Control and Prevention and the Administration of 

7 the Health Resources Services Administration and 

8 the Office of Infectious Disease and HIV/AIDS Pol9 icy, shall establish a provider campaign for the pur10 pose of educating prescribers and other associated 

11 health professionals on medication for the prevention 

12 of HIV acquisition. 

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

14 subsection, the Secretary shall increase awareness 

15 and readiness among health care providers to offer 

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

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

18 underutilized by developing an educational campaign 

19 with input from health care providers and organiza20 tions that are indigenous to communities that are 

21 overrepresented in the domestic HIV epidemic, in22 cluding communities of color and the lesbian, gay, 

23 bisexual, transgender, and queer community. The 

24 Secretary shall ensure that the campaign is designed 

25 to increase awareness of the safety and effectiveness 


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1 of PrEP and PEP, the recommended clinical prac2 tices for providing PrEP-related and PEP-related 

3 clinical care, cultural competency among PrEP and 

4 PEP prescribers, and to counter stigma associated 

5 with the use of PrEP and PEP. 

6 ‘‘(3) EVALUATION OF PROGRAM.—The Sec7 retary shall develop measures to evaluate the effec8 tiveness of activities conducted under this subsection 

9 that are aimed at increasing the number of health 

10 care professionals offering PrEP and PEP and re11 ducing disparities in access to PrEP and PEP. Such 

12 measures shall evaluate availability of PrEP and 

13 PEP services, education and outreach activities, lan14 guage services, workforce cultural competence, and 

15 other areas as determined by the Secretary. 

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

17 399V–8— 

18 ‘‘(1) the term ‘PEP’ means any drug or com19 bination of drugs approved by the Food and Drug 

20 Administration for preventing HIV infection after a 

21 sexual or other exposure associated with a high risk 

22 of HIV transmission; and 

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

24 by the Food and Drug Administration for the purVerDate Sep 11 2014 23:23 Dec 10, 2021 Jkt 029200 PO 00000 Frm 00027 Fmt 6652 Sfmt 6201 E:\BILLS\H6117.IH H6117

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1 pose of pre-exposure prophylaxis with respect to 

2 HIV. 

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

4 carry out this section, there are authorized to be appro5 priated such sums as may be necessary for each of fiscal 

6 years 2023 through 2028.’’. 

7 SEC. 6. PATIENT CONFIDENTIALITY. 

8 The Secretary of Health and Human Services shall 

9 amend the regulations promulgated under section 264(c) 

10 of the Health Insurance Portability and Accountability 

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

12 ensure that individuals are able to access the benefits de13 scribed in section 2713(a)(6) under a family plan without 

14 any other individual enrolled in such family plan, including 

15 a primary subscriber of or policyholder, being informed of 

16 such use of such benefits. 

17 SEC. 7. PRE-EXPOSURE PROPHYLAXIS AND POST-EXPO18 SURE PROPHYLAXIS FUNDING. 

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

20 (42 U.S.C. 280g et seq.), as amended by section 5, is fur21 ther amended by adding at the end the following: 

22 ‘‘SEC. 399V–8. PRE-EXPOSURE PROPHYLAXIS AND POST-EX23 POSURE PROPHYLAXIS FUNDING. 

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

25 date of enactment of the PrEP Access and Coverage Act, 


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1 the Secretary shall establish a program that awards grants 

2 to States, territories, Indian Tribes, and directly eligible 

3 entities for the establishment and support of pre-exposure 

4 prophylaxis (referred to in this section as ‘PrEP’) and 

5 post-exposure prophylaxis (referred to in this section as 

6 ‘PEP’) programs. 

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

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

9 Tribe, or directly eligible entity shall— 

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

11 such time, in such manner, and containing such in12 formation as the Secretary may require, including a 

13 plan describing how any funds awarded will be used 

14 to increase access to PrEP for uninsured and under15 insured individuals and reduce disparities in access 

16 to PrEP and PEP for uninsured and underinsured 

17 individuals and reduce disparities in access to PrEP 

18 and PEP; and 

19 ‘‘(2) appoint a PrEP and PEP grant adminis20 trator to manage the program. 

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

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

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

24 or other nonprofit entity engaged in providing PrEP 

25 and PEP information and services; and 


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1 ‘‘(2) may include— 

2 ‘‘(A) a Federally qualified health center 

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

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

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

6 States) funded under section 1001 of the Public 

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

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

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

10 (42 U.S.C. 1395x(aa)(2)); 

11 ‘‘(D) a health facility operated by or pur12 suant to a contract with the Indian Health 

13 Service; 

14 ‘‘(E) a community-based organization, clin15 ic, hospital, or other health facility that pro16 vides services to individuals at risk for or living 

17 with HIV; and 

18 ‘‘(F) a nonprofit private entity providing 

19 comprehensive primary care to populations at 

20 risk of HIV, including faith-based and commu21 nity-based organizations. 

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

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

24 Secretary shall consider the grant application and the 

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


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1 of uninsured and underinsured individuals in the area, and 

2 how the State, territory, or Indian Tribe coordinates 

3 PrEP and PEP activities with the directly funded entity, 

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

5 funds. 

6 ‘‘(e) USE OF FUNDS.— 

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

8 Tribe, or directly eligible entity that is awarded 

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

10 eligible PrEP and PEP expenses. 

11 ‘‘(2) ELIGIBLE PREP EXPENSES.—The Sec12 retary shall publish a list of expenses that qualify as 

13 eligible PrEP and PEP expenses for purposes of this 

14 section, which shall include— 

15 ‘‘(A) any prescription drug approved by 

16 the Food and Drug Administration for the pre17 vention of HIV, administrative fees for such 

18 drugs, laboratory and other diagnostic proce19 dures associated with the use of such drugs, 

20 and clinical follow up and monitoring, including 

21 any related services recommended in current 

22 United States Public Health Service clinical 

23 practice guidelines, without 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 and 

3 PEP, provide education about access to and 

4 health care coverage of PrEP and PEP, PrEP 

5 and PEP adherence programs, and counter 

6 stigma associated with the use of PrEP and 

7 PEP; and 

8 ‘‘(C) outreach activities directed toward 

9 physicians and other providers that provide 

10 education about PrEP and PEP. 

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

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

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

14 submit to Congress, and make public on the internet 

15 website of Department of Health and Human Services, a 

16 report on the impact of any grants provided to States, ter17 ritories, and Indian Tribes and directly eligible entities for 

18 the establishment and support of pre-exposure prophylaxis 

19 programs under this section. 

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

21 carry out this section, there are authorized to be appro22 priated such sums as may be necessary for each of fiscal 

23 years 2023 through 2028.’’. 


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1 SEC. 8. CLARIFICATION. 

2 This Act, including the amendments made by this 

3 Act, shall apply notwithstanding any other provision of 

4 law, including Public Law 103–141. 

5 SEC. 9. PRIVATE RIGHT OF ACTION. 

6 Any person aggrieved by a violation of this Act, in7 cluding the amendments made by this Act, may commence 

8 a civil action in an appropriate United States District 

9 Court or other court of competent jurisdiction to obtain 

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

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

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

13 costs and reasonable attorney fees of the plaintiff. 

Æ 


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