th st congress session h. r. 3815 · 2020. 3. 26. · 3 •hr 3815 ih 1 (5) many individuals at...

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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. BARRAGÁN, 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 jurisdic-tion of the committee concerned

A BILL To increase access to pre-exposure prophylaxis to reduce

the transmission of HIV.

Be it enacted by the Senate and House of Representa-1

tives of the United States of America in Congress assembled, 2

SECTION 1. SHORT TITLE. 3

This Act may be cited as the ‘‘PrEP Access and Cov-4

erage Act’’. 5

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SEC. 2. FINDINGS. 1

Congress finds as follows: 2

(1) The Centers for Disease Control and Pre-3

vention estimates that approximately 1,100,000 peo-4

ple in the United States are living with HIV. 5

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

of HIV in the United States. 7

(3) HIV disproportionately impacts gay and bi-8

sexual men, transgender women, and, in particular, 9

people of color. For example, in 2017 approximately 10

66 percent of new HIV diagnoses were among gay 11

and bisexual men, 43 percent of new HIV diagnoses 12

were among Black people, and 26 percent of new 13

HIV diagnoses were among Latinx people. Recent 14

studies suggest that transgender women are up to 15

49 times more likely to be diagnosed with HIV than 16

the general population. Members of communities at 17

the intersections of these groups are most heavily 18

impacted. 19

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

section as ‘‘PrEP’’) is a daily antiretroviral medica-21

tion that helps prevent individuals from acquiring 22

HIV. Daily PrEP use reduces the risk of getting 23

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

of getting HIV from injection drug use by over 70 25

percent. 26


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

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

people in the United States who could benefit from 3

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

prescriptions for the drug in 2016. 5

(6) PrEP usage is inconsistent across racial 6

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

percent White, 11.2 percent Black, and 13.1 percent 8

Latinx. However, individuals eligible for PrEP were 9

26.3 percent White, 43.7 percent Black, and 24.7 10

percent Latinx. Additionally, only 2.1 percent of 11

women eligible for PrEP received a prescription in 12

2016. 13

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

approved by the Food and Drug Administration, 15

marketed under the brand name of Truvada, which, 16

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

the United States. A less expensive, generic version 18

of PrEP is expected to be available in September 19

2020, and other types of HIV prevention treat-20

ments, including oral pills, vaginal rings, and long- 21

acting injectables, are currently in the research pipe-22

line. 23

(8) Section 2713 of the Public Health Service 24

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


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health insurance plans to cover preventive services 1

without cost sharing, including such services with a 2

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

United States Preventive Services Task Force. On 4

June 11, 2019, the United States Preventive Serv-5

ices Task Force issued a final recommendation giv-6

ing an ‘‘A’’ grade for PrEP for individuals at high 7

risk of HIV; non-grandfathered private health insur-8

ance plans will have to cover PrEP for such individ-9

uals without cost sharing by 2021. 10

(9) Despite such recommendation of the United 11

States Preventive Services Task Force, access bar-12

riers to PrEP remain. Ancillary services necessary to 13

maintain the PrEP regime, including subsequent 14

provider visits, clinical testing, and other services, 15

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

the new recommendations are not linked to coverage 17

requirements for individuals with other types of in-18

surance, such as Medicare or Medicaid. 19

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

ancillary services for all individuals, including indi-21

viduals who do not have health insurance, is a crit-22

ical step towards eliminating HIV transmission. 23


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SEC. 3. COVERAGE OF HIV TESTING AND PREVENTION 1

SERVICES. 2

(a) PRIVATE INSURANCE.— 3

(1) IN GENERAL.—Section 2713(a) of the Pub-4

lic Health Service Act (42 U.S.C. 300gg–13(a)) is 5

amended— 6

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

and inserting a semicolon; 8

(B) in paragraph (3), by striking the pe-9

riod and inserting a semicolon; 10

(C) in paragraph (4), by striking the pe-11

riod and inserting a semicolon; 12

(D) in paragraph (5), by striking the pe-13

riod and inserting ‘‘; and’’; and 14

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

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

Food and Drug Administration for the prevention of 17

HIV acquisition, laboratory and other diagnostic 18

procedures associated with the use of such drugs, 19

and clinical follow up and monitoring, including any 20

related services recommended in current United 21

States Public Health Service clinical practice guide-22

lines, without limitation.’’. 23

(2) PROHIBITION ON PREAUTHORIZATION RE-24

QUIREMENTS.—Subpart II of part A of title XXVII 25

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


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11 et seq.) is amended by adding at the end the fol-1

lowing: 2

‘‘SEC. 2729. PROHIBITION ON PREAUTHORIZATION RE-3

QUIREMENTS WITH RESPECT TO CERTAIN 4

SERVICES. 5

‘‘A group health plan or a health insurance issuer of-6

fering group or individual health insurance coverage shall 7

not impose any pre-authorization requirements with re-8

spect to coverage of the services described in section 9

2713(a)(6).’’. 10

(b) COVERAGE UNDER FEDERAL EMPLOYEES 11

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

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

following: 14

‘‘(c) Any health benefits plan offered under this chap-15

ter shall include benefits for, and may not impose any cost 16

sharing requirements for, any prescription drug approved 17

by the Food and Drug Administration for the prevention 18

of HIV acquisition, laboratory and other diagnostic proce-19

dures associated with the use of such drugs, and clinical 20

follow up and monitoring, including any related services 21

recommended in current United States Public Health 22

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

(c) MEDICAID.— 24


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

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

(A) in subsection (a)(4)— 3

(i) by striking ‘‘and (D)’’ and insert-4

ing ‘‘(D)’’; and 5

(ii) by inserting ‘‘; and (E) HIV pre-6

vention services’’ before the semicolon; and 7

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

subsection: 9

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

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

means prescription drugs for the prevention of HIV acqui-12

sition, laboratory and other diagnostic procedures associ-13

ated with the use of such drugs, and clinical follow up 14

and monitoring, including any related services rec-15

ommended in current United States Public Health Service 16

clinical practice guidelines, without limitation.’’. 17

(2) NO COST SHARING.—Title XIX of the So-18

cial Security Act (42 U.S.C. 1396 et seq.) is amend-19

ed— 20

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

prevention services described in section 22

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

each place it appears; and 24


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

at the end the following new clause: 2

‘‘(xi) HIV prevention services de-3

scribed in section 1905(a)(4)(E).’’. 4

(3) INCLUSION IN BENCHMARK COVERAGE.— 5

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

U.S.C. 1396u–7(b)(7)) is amended— 7

(A) in the paragraph header, by inserting 8

‘‘AND HIV PREVENTION SERVICES’’ after ‘‘SUP-9

PLIES’’; and 10

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

described in section 1905(a)(4)(E), medical as-12

sistance for HIV prevention services in accord-13

ance with such section’’ before the period. 14

(d) CHIP.— 15

(1) IN GENERAL.—Section 2103(c) of the So-16

cial Security Act (42 U.S.C. 1397cc(c)), as amended 17

by section 5022 of the SUPPORT for Patients and 18

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

by adding at the end the following new paragraph: 20

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

health assistance provided to a targeted low-income 22

child and the pregnancy-related assistance provided 23

to a targeted low-income woman shall include cov-24


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erage of HIV prevention services (as defined in sec-1

tion 1905(ff)).’’. 2

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

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

amended by inserting ‘‘, for HIV prevention services 5

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

(c)(1)(D)’’. 7

(3) CONFORMING AMENDMENT.—Section 8

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

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

SUPPORT for Patients and Communities Act (Pub-11

lic Law 115–271), is amended in the matter pre-12

ceding paragraph (1) by striking ‘‘and (8)’’ and in-13

serting ‘‘(8), and (10)’’. 14

(4) EFFECTIVE DATE.— 15

(A) IN GENERAL.—Subject to subpara-16

graph (A), the amendments made by subsection 17

(c) and this subsection shall take effect on Jan-18

uary 1, 2021. 19

(B) DELAY PERMITTED IF STATE LEGISLA-20

TION REQUIRED.—In the case of a State plan 21

approved under title XIX of the Social Security 22

Act which the Secretary of Health and Human 23

Services determines requires State legislation 24

(other than legislation appropriating funds) in 25


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order for the plan to meet the additional re-1

quirements imposed by this section, the State 2

plan shall not be regarded as failing to comply 3

with the requirements of such title solely on the 4

basis of the failure of the plan to meet such ad-5

ditional requirements before the 1st day of the 6

1st calendar quarter beginning after the close 7

of the 1st regular session of the State legisla-8

ture that ends after the 1-year period beginning 9

with the date of the enactment of this section. 10

For purposes of the preceding sentence, in the 11

case of a State that has a 2-year legislative ses-12

sion, each year of the session is deemed to be 13

a separate regular session of the State legisla-14

ture. 15

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

(1) PART B.— 17

(A) INCLUSION AS A PREVENTIVE SERV-18

ICE.—Section 1861(ddd)(3) of the Social Secu-19

rity Act (42 U.S.C. 1395x(ddd)(3)) is amended 20

by adding at the end the following new sub-21

paragraph: 22

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

Food and Drug Administration for the preven-24

tion of HIV acquisition, laboratory and other 25


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diagnostic procedures associated with the use of 1

such drugs, and clinical follow up and moni-2

toring, including any related services rec-3

ommended in current United States Public 4

Health Service clinical practice guidelines, with-5

out limitation.’’. 6

(B) ELIMINATION OF COINSURANCE.—Sec-7

tion 1833(a)(1) of the Social Security Act (42 8

U.S.C. 1395l(a)(1)) is amended— 9

(i) by striking ‘‘and (CC)’’ and insert-10

ing ‘‘(CC)’’; and 11

(ii) by inserting before the semicolon 12

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

respect to preventive services described in 14

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

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

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

of the actual charge for the service or the 18

amount determined under the fee schedule 19

that applies to such treatment under this 20

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

that are covered OPD services (as defined 22

in subsection (t)(1)(B)), the amount deter-23

mined under subsection (t)’’. 24


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(C) EXEMPTION FROM PART B DEDUCT-1

IBLE.—Section 1833(b) of the Social Security 2

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

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

‘‘and’’ at the end; and 5

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

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

such deductible shall not apply with re-8

spect to preventive services described in 9

subparagraph (D) of section 10

1861(ddd)(3).’’. 11

(D) EFFECTIVE DATE.—The amendments 12

made by this paragraph shall apply to items 13

and services furnished on or after January 1, 14

2021. 15

(2) PART D.— 16

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

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

102(b)) is amended— 19

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

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

paragraph (8), the coverage’’; 22

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

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

paragraph (8)’’; 25


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

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

(iv) in paragraph (4)(A)(i), by strik-3

ing ‘‘The coverage’’ and inserting ‘‘Subject 4

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

(v) by adding at the end the following 6

new paragraph: 7

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

DRUGS FOR THE PREVENTION OF HIV ACQUISI-9

TION.— 10

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

and each subsequent plan year, there shall be 12

no cost-sharing under this part (including 13

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

drugs that are for the prevention of HIV acqui-15

sition. 16

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

subparagraph (A), the elimination of cost-shar-18

ing shall include the following: 19

‘‘(i) NO APPLICATION OF DEDUCT-20

IBLE.—The waiver of the deductible under 21

paragraph (1). 22

‘‘(ii) NO APPLICATION OF COINSUR-23

ANCE.—There waiver of coinsurance under 24

paragraph (2). 25


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‘‘(iii) NO APPLICATION OF INITIAL 1

COVERAGE LIMIT.—The initial coverage 2

limit under paragraph (3) shall not apply. 3

‘‘(iv) NO COST SHARING ABOVE AN-4

NUAL OUT-OF-POCKET THRESHOLD.—The 5

waiver of cost sharing under paragraph 6

(4).’’. 7

(B) CONFORMING AMENDMENTS TO COST 8

SHARING FOR LOW-INCOME INDIVIDUALS.—Sec-9

tion 1860D–14(a) of the Social Security Act 10

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

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

preceding subparagraph (A), by striking 13

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

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

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

preceding subparagraph (A), by striking 17

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

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

(f) COVERAGE OF HIV PREVENTION TREATMENT BY 20

DEPARTMENT OF VETERANS AFFAIRS.— 21

(1) ELIMINATION OF MEDICATION COPAY-22

MENTS.—Section 1722A(a) of title 38, United 23

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

following new paragraph: 25


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

for the prevention of HIV acquisition.’’. 2

(2) ELIMINATION OF HOSPITAL CARE AND MED-3

ICAL SERVICES COPAYMENTS.—Section 1710 of such 4

title is amended— 5

(A) in subsection (f)— 6

(i) by redesignating paragraph (5) as 7

paragraph (6); and 8

(ii) by inserting after paragraph (4) 9

the following new paragraph (5): 10

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

under this subsection for any amounts for laboratory and 12

other diagnostic procedures associated with the use of any 13

prescription drug approved by the Food and Drug Admin-14

istration for the prevention of HIV acquisition, or for lab-15

oratory or other diagnostic procedures associated with the 16

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

including any related services recommended in current 18

United States Public Health Service clinical practice 19

guidelines, without limitation.’’; and 20

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

end the following new subparagraph: 22

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

Food and Drug Administration for the prevention of 24

HIV acquisition, laboratory and other diagnostic 25


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procedures associated with the use of such drugs, 1

and clinical follow up and monitoring, including any 2

related services recommended in current United 3

States Public Health Service clinical practice guide-4

lines, without limitation.’’. 5

(3) INCLUSION AS PREVENTIVE HEALTH SERV-6

ICE.—Section 1701(9) of such title is amended— 7

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

and’’ and inserting a semicolon; 9

(B) by redesignating subparagraph (L) as 10

subparagraph (M); and 11

(C) by inserting after subparagraph (K) 12

the following new subparagraph (L): 13

‘‘(L) any prescription drug approved by 14

the Food and Drug Administration for the pre-15

vention of HIV acquisition, laboratory and 16

other diagnostic procedures associated with the 17

use of such drugs, and clinical follow up and 18

monitoring, including any related services rec-19



out limitation; and’’. 22

(g) COVERAGE OF HIV PREVENTION TREATMENT BY 23

DEPARTMENT OF DEFENSE.— 24


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

United States Code, is amended by inserting after 2

section 1079c the following new section: 3

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

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

ensure coverage under the TRICARE program of HIV 6

prevention treatment described in subsection (b) for any 7

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

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

HIV prevention treatment described in this subsection in-10

cludes any prescription drug approved by the Food and 11

Drug Administration for the prevention of HIV acquisi-12

tion, laboratory and other diagnostic procedures associ-13

ated with the use of such drugs, and clinical follow up 14

and monitoring, including any related services rec-15


clinical practice guidelines, without limitation. 17

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

1075, 1075a, or 1074g(a)(6) of this title or any other pro-19

vision of law, there is no cost-sharing requirement for HIV 20

prevention treatment covered under this section.’’. 21

(2) CLERICAL AMENDMENT.—The table of sec-22

tions at the beginning of such chapter is amended 23

by inserting after the item relating to section 1079c 24

the following new item: 25

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


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(h) INDIAN HEALTH SERVICE TESTING, MONI-1

TORING, AND PRESCRIPTION DRUGS FOR THE PREVEN-2

TION OF HIV ACQUISITION.—The Indian Health Care Im-3

provement Act is amended by inserting after section 223 4

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

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

DRUGS FOR THE PREVENTION OF HIV ACQUI-7

SITION. 8

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

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

provide funding for any prescription drug approved by the 11

Food and Drug Administration for the prevention of HIV 12

acquisition, laboratory and other diagnostic procedures as-13

sociated with the use of such drugs, and clinical follow 14

up and monitoring, including any related services rec-15


clinical practice guidelines, without limitation. 17

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

are authorized to be appropriated to carry out this section 19

such sums as may be necessary.’’. 20

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

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

with respect to plan years beginning on or after January 23

1, 2021. 24


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SEC. 4. PROHIBITION ON DENIAL OF COVERAGE OR IN-1

CREASE IN PREMIUMS OF LIFE, DISABILITY, 2

OR LONG-TERM CARE INSURANCE FOR INDI-3

VIDUALS TAKING MEDICATION FOR THE PRE-4

VENTION OF HIV ACQUISITION. 5

(a) PROHIBITION.—Notwithstanding any other provi-6

sion of law, it shall be unlawful to— 7

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

any life insurance policy, disability insurance policy, 9

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

individual taking medication for the purpose of pre-11

venting the acquisition of HIV; 12

(2) preclude an individual from taking medica-13

tion for the purpose of preventing the acquisition of 14

HIV as a condition of receiving a life insurance pol-15

icy, disability insurance policy, or long-term care in-16

surance policy; 17

(3) consider whether an individual is taking 18

medication for the purpose of preventing the acquisi-19

tion of HIV in determining the premium rate for 20

coverage of such individual under a life insurance 21

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

insurance policy; or 23

(4) otherwise discriminate in the offering, 24

issuance, cancellation, amount of such coverage, 25

price, or any other condition of a life insurance pol-26


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icy, disability insurance policy, or long-term care in-1

surance policy for an individual, based solely and 2

without any additional actuarial risks upon whether 3

the individual is taking medication for the purpose 4

of preventing the acquisition of HIV. 5

(b) ENFORCEMENT.—A State insurance regulator 6

may take such actions to enforce subsection (a) as are spe-7

cifically authorized under the laws of such State. 8

(c) DEFINITIONS.—In this section: 9

(1) DISABILITY INSURANCE POLICY.—The term 10

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

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

money in the event that an illness or injury resulting 13

in a disability prevents such person from working. 14

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

insurance policy’’ means a contract under which an 16

entity promises to pay a designated beneficiary a 17

sum of money upon the death of the insured. 18

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

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

a contract for which the only insurance protection 21

provided under the contract is coverage of qualified 22

long-term care services (as defined in section 23

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


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SEC. 5. PUBLIC EDUCATION CAMPAIGN. 1

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

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

the following: 4

‘‘SEC. 399V–7. PRE-EXPOSURE PROPHYLAXIS PUBLIC EDU-5

CATION CAMPAIGN. 6

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

the Director of the Centers for Disease Control and Pre-8

vention, shall establish a public health campaign for the 9

purpose of educating the public on medication for the pre-10

vention of HIV acquisition. 11

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

the Secretary shall ensure cultural competency and effi-13

cacy within high-need communities in which PrEP is un-14

derutilized by developing the campaign in collaboration 15

with organizations that are indigenous to communities 16

that are overrepresented in the domestic HIV epidemic, 17

including communities of color and the lesbian, gay, bisex-18

ual, transgender, and queer community. The Secretary 19

shall ensure that the campaign is designed to increase 20

awareness of the safety and effectiveness of PrEP, the rec-21

ommended clinical practices for providing PrEP-related 22

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

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

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

shall develop measures to evaluate the effectiveness of ac-26


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tivities conducted under this section that are aimed at re-1

ducing disparities in access to PrEP and supporting the 2

local community. Such measures shall evaluate community 3

outreach activities, language services, workforce cultural 4

competence, and other areas as determined by the Sec-5

retary. 6

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

any drug approved by the Food and Drug Administration 8

for the purpose of pre-exposure prophylaxis with respect 9

to HIV. 10

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

are authorized to be appropriated such sums as may be 12

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

SEC. 6. PATIENT CONFIDENTIALITY. 14

The Secretary of Health and Human Services shall 15

amend the regulations promulgated under section 264(c) 16

of the Health Insurance Portability and Accountability 17

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

ensure that individuals are able to access the benefits de-19

scribed in section 2713(a)(6) under a family plan without 20

any other individual enrolled in such family plan, including 21

a primary subscriber of or policyholder, being informed of 22

such use of such benefits. 23


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•HR 3815 IH

SEC. 7. PRE-EXPOSURE PROPHYLAXIS FUNDING. 1

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

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

Human Services (in this Act referred to as the ‘‘Sec-4

retary’’) shall establish a program that provides grants to 5

States, territories, and Indian Tribes for the establishment 6

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

this section as ‘‘PrEP’’) programs, or establishes a pro-8

gram for providing Federal funding directly to eligible en-9

tities within a State, territory, or Indian Tribal territory, 10

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

not apply for such a grant. 12

(b) GRANT PROGRAM.— 13

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

grant under subsection (a), a State, territory, or In-15

dian Tribe shall— 16

(A) submit an application to the Secretary 17

at such time, in such manner, and containing 18

such information as the Secretary may require, 19

including a description of how any funds award-20

ed will be used and a plan describing how any 21

funds awarded will be used to increase access to 22

PrEP for uninsured individuals and reduce dis-23

parities in access to PrEP; and 24

(B) appoint a PrEP grant administrator to 25

manage the program. 26


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•HR 3815 IH

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

the United States, or Indian tribe that is awarded 2

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

eligible PrEP expenses. 4

(c) FEDERAL PROGRAM.— 5

(1) IN GENERAL.—In the case of a State, terri-6

tory, or Indian Tribe that does not submit an appli-7

cation under subsection (b), the Secretary shall pro-8

vide funding to any of the following, within the ap-9

plicable State, territory, or Indian Tribal territory: 10

(A) Federally qualified health centers (as 11

defined in section 1861(aa)(4) of the Social Se-12

curity Act (42 U.S.C. 1395x(aa)(4))). 13

(B) Family planning grantees (other than 14

States) funded under section 1001 of the Public 15

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

(C) Rural health clinics (as defined in sec-17

tion 1861(aa)(2) of the Social Security Act (42 18

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

(D) Health facilities operated by or pursu-20

ant to a contract with the Indian Health Serv-21

ice. 22

(E) Community-based organizations, clin-23

ics, hospitals, and other health facilities that 24


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provide services to individuals at risk for or liv-1

ing with HIV. 2

(F) Nonprofit private entities providing 3

comprehensive primary care to populations at 4

risk of HIV, including faith-based and commu-5

nity-based organizations. 6

(2) USE OF FUNDS.—Any entity receiving fund-7

ing under paragraph (1) shall use such funds for eli-8

gible PrEP expenses. 9

(d) ELIGIBLE PREP EXPENSES.— 10

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

a list of expenses that qualify as eligible PrEP ex-12

penses for purposes of this section. 13

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

(A) any prescription drug approved by the 15

Food and Drug Administration for the preven-16

tion of HIV acquisition, laboratory and other 17

diagnostic procedures associated with the use of 18

such drugs, and clinical follow up and moni-19

toring, including any related services rec-20



out limitation; 23

(B) outreach and public education activi-24

ties directed toward populations overrepresented 25


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•HR 3815 IH

in the domestic HIV epidemic that increase 1

awareness about the existence of PrEP, provide 2

education about access to and health care cov-3

erage of PrEP, and counter stigma associated 4

with the use of PrEP; and 5

(C) outreach activities directed toward 6

physicians and other providers that provide 7

education about PrEP. 8

(e) 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 this Act, submit to Congress, and 11

make public on the internet website of Department of 12

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

any grants provided to States, territories, and Indian 14

Tribes for the establishment and support of pre-exposure 15

prophylaxis programs under this section. 16

(f) AUTHORIZATION OF APPROPRIATIONS.—There 17

are authorized to be appropriated to carry out this section 18

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

after the date of the enactment of this section. 20

SEC. 8. CLARIFICATION. 21

This Act, including the amendments made by this 22

Act, shall apply notwithstanding any other provision of 23

law, including Public Law 103–141. 24


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SEC. 9. PRIVATE RIGHT OF ACTION. 1

Any person aggrieved by a violation of this Act, in-2

cluding the amendments made by this Act, may commence 3

a civil action in an appropriate United States District 4

Court or other court of competent jurisdiction to obtain 5

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

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

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

costs and reasonable attorney fees of the plaintiff. 9

Æ


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th st congress session h. r. 3815 · 2020. 3. 26. · 3 •hr 3815 ih 1 (5) many individuals at...

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