PrEP Access and Coverage Act

I 116TH CONGRESS 1ST SESSION H. R. 3815 To increase access to pre-exposure prophylaxis to reduce the transmission of HIV. IN THE HOUSE OF REPRESENTATIVES JULY 17, 2019 Mr. SCHIFF (for himself, Mrs. WATSON COLEMAN, Ms. LEE of California, Mr. KHANNA, Ms. MUCARSEL-POWELL, Mr. RUSH, Mr. CRIST, Ms. BARRAGA´N, Ms. HAALAND, Mr. PAPPAS, Mr. MOULTON, Mr. COX of California, Mr. COHEN, and Ms. PRESSLEY) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on Oversight and Reform, Veterans’ Affairs, Ways and Means, Natural Resources, Armed Services, and Financial Services, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the 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 VerDate Sep 11 2014 04:29 Aug 01, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3815.IH H3815 kjohnson on DSK79L0C42 with BILLS 2 •HR 3815 IH 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 VerDate Sep 11 2014 04:29 Aug 01, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3815.IH H3815 kjohnson on DSK79L0C42 with BILLS 3 •HR 3815 IH (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 VerDate Sep 11 2014 04:29 Aug 01, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3815.IH H3815 kjohnson on DSK79L0C42 with BILLS 4 •HR 3815 IH 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 VerDate Sep 11 2014 04:29 Aug 01, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3815.IH H3815 kjohnson on DSK79L0C42 with BILLS 5 •HR 3815 IH 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 VerDate Sep 11 2014 04:29 Aug 01, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3815.IH H3815 kjohnson on DSK79L0C42 with BILLS 6 •HR 3815 IH 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 VerDate Sep 11 2014 04:29 Aug 01, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H3815.IH H3815 kjohnson on DSK79L0C42 with BILLS 7 •HR 3815 IH (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 VerDate Sep 11 2014 04:29 Aug 01, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H3815.IH H3815 kjohnson on DSK79L0C42 with BILLS 8 •HR 3815 IH (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 VerDate Sep 11 2014 04:29 Aug 01, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H3815.IH H3815 kjohnson on DSK79L0C42 with BILLS 9 •HR 3815 IH 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 VerDate Sep 11 2014 04:29 Aug 01, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H3815.IH H3815 kjohnson on DSK79L0C42 with BILLS 10 •HR 3815 IH 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 VerDate Sep 11 2014 04:29 Aug 01, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H3815.IH H3815 kjohnson on DSK79L0C42 with BILLS 11 •HR 3815 IH 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 VerDate Sep 11 2014 04:29 Aug 01, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H3815.IH H3815 kjohnson on DSK79L0C42 with BILLS 12 •HR 3815 IH (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 A [Text truncated for display. 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