PrEP Access and Coverage Act

II 116TH CONGRESS 1ST SESSION S. 1926 To increase access to pre-exposure prophylaxis to reduce the transmission of HIV. IN THE SENATE OF THE UNITED STATES JUNE 20, 2019 Ms. HARRIS introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To increase access to pre-exposure prophylaxis to reduce the transmission of HIV. 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 SEC. 2. FINDINGS. 6 Congress finds as follows: 7 (1) The Centers for Disease Control and Pre- 8 vention estimates that approximately 1,100,000 peo- 9 ple in the United States are living with HIV. 10 VerDate Sep 11 2014 00:36 Jun 22, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1926.IS S1926 kjohnson on DSK79L0C42 with BILLS 2 •S 1926 IS (2) In 2017, there were 38,281 new diagnoses 1 of HIV in the United States. 2 (3) HIV disproportionately impacts gay and bi- 3 sexual men, transgender women, and, in particular, 4 people of color. For example, in 2017 approximately 5 66 percent of new HIV diagnoses were among gay 6 and bisexual men, 43 percent of new HIV diagnoses 7 were among Black people, and 26 percent of new 8 HIV diagnoses were among Latinx people. Recent 9 studies suggest that transgender women are up to 10 49 times more likely to be diagnosed with HIV than 11 the general population. Members of communities at 12 the intersections of these groups are most heavily 13 impacted. 14 (4) Pre-exposure prophylaxis (referred to in this 15 section as ‘‘PrEP’’) is a daily antiretroviral medica- 16 tion that helps prevent individuals from acquiring 17 HIV. Daily PrEP use reduces the risk of getting 18 HIV from sex by over 90 percent. It reduces the risk 19 of getting HIV from injection drug use by over 70 20 percent. 21 (5) Many individuals at risk of exposure to HIV 22 do not use PrEP. Of the approximately 1,100,000 23 people in the United States who could benefit from 24 VerDate Sep 11 2014 00:36 Jun 22, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1926.IS S1926 kjohnson on DSK79L0C42 with BILLS 3 •S 1926 IS PrEP, only 7 percent, or 78,360 individuals, filled 1 prescriptions for the drug in 2016. 2 (6) PrEP usage is inconsistent across racial 3 and gender lines. In 2016, PrEP users were 68.7 4 percent White, 11.2 percent Black, and 13.1 percent 5 Latinx. However, individuals eligible for PrEP were 6 26.3 percent White, 43.7 percent Black, and 24.7 7 percent Latinx. Additionally, only 2.1 percent of 8 women eligible for PrEP received a prescription in 9 2016. 10 (7) There is currently only one version of PrEP 11 approved by the Food and Drug Administration, 12 marketed under the brand name of Truvada, which, 13 in 2018, had a list price of over $20,000 a year in 14 the United States. A less expensive, generic version 15 of PrEP is expected to be available in September 16 2020, and other types of HIV prevention treat- 17 ments, including oral pills, vaginal rings, and long- 18 acting injectables, are currently in the research pipe- 19 line. 20 (8) Section 2713 of the Public Health Service 21 Act (42 U.S.C. 300gg–13) requires most private 22 health insurance plans to cover preventive services 23 without cost-sharing, including such services with a 24 rating of ‘‘A’’ or ‘‘B’’ under recommendations of the 25 VerDate Sep 11 2014 00:36 Jun 22, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1926.IS S1926 kjohnson on DSK79L0C42 with BILLS 4 •S 1926 IS United States Preventive Services Task Force. On 1 June 11, 2019, the United States Preventive Serv- 2 ices Task Force issued a final recommendation giv- 3 ing an ‘‘A’’ grade for PrEP for individuals at high 4 risk of HIV; non-grandfathered private health insur- 5 ance plans will have to cover PrEP for such individ- 6 uals without cost-sharing by 2021. 7 (9) Despite such recommendation of the United 8 States Preventive Services Task Force, access bar- 9 riers to PrEP remain. Ancillary services necessary to 10 maintain the PrEP regime, including subsequent 11 provider visits, clinical testing, and other services, 12 can remain a cost-burden on patients. Additionally, 13 the new recommendations are not linked to coverage 14 requirements for individuals with other types of in- 15 surance, such as Medicare or Medicaid. 16 (10) Expanding access to cost-free PrEP and 17 ancillary services for all individuals, including indi- 18 viduals who do not have health insurance, is a crit- 19 ical step towards eliminating HIV transmission. 20 SEC. 3. COVERAGE OF HIV TESTING AND PREVENTION 21 SERVICES. 22 (a) PRIVATE INSURANCE.— 23 VerDate Sep 11 2014 00:36 Jun 22, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1926.IS S1926 kjohnson on DSK79L0C42 with BILLS 5 •S 1926 IS (1) IN GENERAL.—Section 2713(a) of the Pub- 1 lic Health Service Act (42 U.S.C. 300gg–13(a)) is 2 amended— 3 (A) in paragraph (2), by striking ‘‘; and’’ 4 and inserting a semicolon; 5 (B) in paragraph (3), by striking the pe- 6 riod and inserting a semicolon; 7 (C) in paragraph (4), by striking the pe- 8 riod and inserting a semicolon; 9 (D) in paragraph (5), by striking the pe- 10 riod and inserting ‘‘; and’’; and 11 (E) by adding at the end the following: 12 ‘‘(6) any prescription drug approved by the 13 Food and Drug Administration for the prevention of 14 HIV acquisition, laboratory and other diagnostic 15 procedures associated with the use of such drugs, 16 and clinical follow up and monitoring, including any 17 related services recommended in current United 18 States Public Health Service clinical practice guide- 19 lines, without limitation.’’. 20 (2) PROHIBITION ON PREAUTHORIZATION RE- 21 QUIREMENTS.—Subpart II of part A of title XXVII 22 of the Public Health Service Act (42 U.S.C. 300gg– 23 11 et seq.) is amended by adding at the end the fol- 24 lowing: 25 VerDate Sep 11 2014 00:36 Jun 22, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1926.IS S1926 kjohnson on DSK79L0C42 with BILLS 6 •S 1926 IS ‘‘SEC. 2729. PROHIBITION ON PREAUTHORIZATION RE- 1 QUIREMENTS WITH RESPECT TO CERTAIN 2 SERVICES. 3 ‘‘A group health plan or a health insurance issuer of- 4 fering group or individual health insurance coverage shall 5 not impose any pre-authorization requirements with re- 6 spect to coverage of the services described in section 7 2713(a)(6).’’. 8 (b) COVERAGE UNDER FEDERAL EMPLOYEES 9 HEALTH BENEFITS PROGRAM.—Section 8904 of title 5, 10 United States Code, is amended by adding at the end the 11 following: 12 ‘‘(c) Any health benefits plan offered under this chap- 13 ter shall include benefits for, and may not impose any cost 14 sharing requirements for, any prescription drug approved 15 by the Food and Drug Administration for the prevention 16 of HIV acquisition, laboratory and other diagnostic proce- 17 dures associated with the use of such drugs, and clinical 18 follow up and monitoring, including any related services 19 recommended in current United States Public Health 20 Service clinical practice guidelines, without limitation.’’. 21 (c) MEDICAID.— 22 (1) IN GENERAL.—Section 1905 of the Social 23 Security Act (42 U.S.C. 1396d) is amended— 24 (A) in subsection (a)(4)— 25 VerDate Sep 11 2014 00:36 Jun 22, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1926.IS S1926 kjohnson on DSK79L0C42 with BILLS 7 •S 1926 IS (i) by striking ‘‘and (D)’’ and insert- 1 ing ‘‘(D)’’; and 2 (ii) by inserting ‘‘; and (E) HIV pre- 3 vention services’’ before the semicolon; and 4 (B) by adding at the end the following new 5 subsection: 6 ‘‘(ff) HIV PREVENTION SERVICES.—For purposes of 7 subsection (a)(4)(E), the term ‘HIV prevention services’ 8 means prescription drugs for the prevention of HIV acqui- 9 sition, laboratory and other diagnostic procedures associ- 10 ated with the use of such drugs, and clinical follow up 11 and monitoring, including any related services rec- 12 ommended in current United States Public Health Service 13 clinical practice guidelines, without limitation.’’. 14 (2) NO COST SHARING.—Title XIX of the So- 15 cial Security Act (42 U.S.C. 1396 et seq.) is amend- 16 ed— 17 (A) in section 1916, by inserting ‘‘HIV 18 prevention services described in section 19 1905(a)(4)(E),’’ after ‘‘section 1905(a)(4)(C),’’ 20 each place it appears; and 21 (B) in section 1916A(b)(3)(B), by adding 22 at the end the following new clause: 23 ‘‘(xi) HIV prevention services de- 24 scribed in section 1905(a)(4)(E).’’. 25 VerDate Sep 11 2014 00:36 Jun 22, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1926.IS S1926 kjohnson on DSK79L0C42 with BILLS 8 •S 1926 IS (3) INCLUSION IN BENCHMARK COVERAGE.— 1 Section 1937(b)(7) of the Social Security Act (42 2 U.S.C. 1396u–7(b)(7)) is amended— 3 (A) in the paragraph header, by inserting 4 ‘‘AND HIV PREVENTION SERVICES’’ after ‘‘SUP- 5 PLIES’’; and 6 (B) by inserting ‘‘, and, for any individual 7 described in section 1905(a)(4)(E), medical as- 8 sistance for HIV prevention services in accord- 9 ance with such section’’ before the period. 10 (d) CHIP.— 11 (1) IN GENERAL.—Section 2103(c) of the So- 12 cial Security Act (42 U.S.C. 1397cc(c)), as amended 13 by section 5022 of the SUPPORT for Patients and 14 Communities Act (Public Law 115–271), is amended 15 by adding at the end the following new paragraph: 16 ‘‘(10) HIV PREVENTION SERVICES.—The child 17 health assistance provided to a targeted low-income 18 child and the pregnancy-related assistance provided 19 to a targeted low-income woman shall include cov- 20 erage of HIV prevention services (as defined in sec- 21 tion 1905(ff)).’’. 22 (2) NO COST SHARING.—Section 2103(e)(2) of 23 the Social Security Act (42 U.S.C. 1397cc(e)(2)) is 24 amended by inserting ‘‘, for HIV prevention services 25 VerDate Sep 11 2014 00:36 Jun 22, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1926.IS S1926 kjohnson on DSK79L0C42 with BILLS 9 •S 1926 IS described in subsection (c)(10),’’ after ‘‘subsection 1 (c)(1)(D)’’. 2 (3) CONFORMING AMENDMENT.—Section 3 2103(a) of the Social Security Act (42 U.S.C. 4 1397cc(a)), as amended by section 5022 of the 5 SUPPORT for Patients and Communities Act (Pub- 6 lic Law 115–271), is amended in the matter pre- 7 ceding paragraph (1) by striking ‘‘and (8)’’ and in- 8 serting ‘‘(8), and (10)’’. 9 (4) EFFECTIVE DATE.— 10 (A) IN GENERAL.—Subject to subpara- 11 graph (A), the amendments made by subsection 12 (c) and this subsection shall take effect on Jan- 13 uary 1, 2021. 14 (B) DELAY PERMITTED IF STATE LEGISLA- 15 TION REQUIRED.—In the case of a State plan 16 approved under title XIX of the Social Security 17 Act which the Secretary of Health and Human 18 Services determines requires State legislation 19 (other than legislation appropriating funds) in 20 order for the plan to meet the additional re- 21 quirements imposed by this section, the State 22 plan shall not be regarded as failing to comply 23 with the requirements of such title solely on the 24 basis of the failure of the plan to meet such ad- 25 VerDate Sep 11 2014 00:36 Jun 22, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1926.IS S1926 kjohnson on DSK79L0C42 with BILLS 10 •S 1926 IS ditional requirements before the 1st day of the 1 1st calendar quarter beginning after the close 2 of the 1st regular session of the State legisla- 3 ture that ends after the 1-year period beginning 4 with the date of the enactment of this section. 5 For purposes of the preceding sentence, in the 6 case of a State that has a 2-year legislative ses- 7 sion, each year of the session is deemed to be 8 a separate regular session of the State legisla- 9 ture. 10 (e) WAIVER OF COST-SHARING UNDER MEDICARE.— 11 (1) PART B.— 12 (A) INCLUSION AS A PREVENTIVE SERV- 13 ICE.—Section 1861(ddd)(3) of the Social Secu- 14 rity Act (42 U.S.C. 1395x(ddd)(3)) is amended 15 by adding at the end the following new sub- 16 paragraph: 17 ‘‘(D) Drugs or biologicals approved by the 18 Food and Drug Administration for the preven- 19 tion of HIV acquisition, laboratory and other 20 diagnostic procedures associated with the use of 21 such drugs, and clinical follow up and moni- 22 toring, including any related services rec- 23 ommended in current United States Public 24 VerDate Sep 11 2014 00:36 Jun 22, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S1926.IS S1926 kjohnson on DSK79L0C42 with BILLS 11 •S 1926 IS Health Service clinical practice guidelines, with- 1 out limitation.’’. 2 (B) ELIMINATION OF COINSURANCE.—Sec- 3 tion 1833(a)(1) of the Social Security Act (42 4 U.S.C. 1395l(a)(1)) is amended— 5 (i) by striking ‘‘and (CC)’’ and insert- 6 ing ‘‘(CC)’’; and 7 (ii) by inserting before the semicolon 8 at the end the following: ‘‘, and (DD) with 9 respect to preventive services described in 10 subparagraph (D) of section 1861(ddd)(3), 11 the amount paid shall be 100 percent of (i) 12 except as provided in clause (ii), the lesser 13 of the actual charge for the service or the 14 amount determined under the fee schedule 15 that applies to such treatment under this 16 part, and (ii) in the case of such services 17 that are covered OPD services (as defined 18 in subsection (t)(1)(B)), the amount deter- 19 mined under subsection (t)’’. 20 (C) EXEMPTION FROM PART B DEDUCT- 21 IBLE.—Section 1833(b) of the Social Security 22 Act (42 U.S.C. 1395l(b)) is amended— 23 (i) in paragraph (9), by striking 24 ‘‘and’’ at the end; and 25 VerDate Sep 11 2014 22:57 Jun 25, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S1926.IS S1926 kjohnson on DSK79L0C42 with BILLS 12 •S 1926 IS (ii) in paragraph (10), by striking the 1 period at the end and inserting ‘‘, and (11) 2 such deductible shall not apply with re- 3 spect to preventive services described in 4 subparagraph (D) of section 5 1861(ddd)(3).’’. 6 (D) EFFECTIVE DATE.—The amendments 7 made by this paragraph shall apply to items 8 and services furnished on or after January 1, 9 2021. 10 (2) PART D.— 11 (A) IN GENERAL.—Section 1860D–2(b) of 12 the Social Security Act (42 U.S.C. 1395w– 13 102(b)) is amended— 14 (i) in paragraph (1)(A), by striking 15 ‘‘The coverage’’ and inserting ‘‘Subject to 16 paragraph (8), the coverage’’; 17 (ii) in paragraph (2)(A), by striking 18 ‘‘and (D)’’ and inserting ‘‘and (D) and 19 paragraph (8)’’; 20 (iii) in paragraph (3)(A), by striking 21 ‘‘and (4)’’ and inserting ‘‘(4), and (8)’’; 22 (iv) in paragraph (4)(A)(i), by strik- 23 ing ‘‘The coverage’’ and inserting ‘‘Subject 24 to paragraph (8), the coverage’’; and 25 VerDate Sep 11 2014 00 [Text truncated for display. 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