VACC Act

II 116TH CONGRESS 2D SESSION S. 4509 To provide for affordable coverage of COVID–19 vaccines under Medicare, Medicaid, and the Children’s Health Insurance Program, and for other purposes. IN THE SENATE OF THE UNITED STATES AUGUST 6, 2020 Mr. WYDEN introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To provide for affordable coverage of COVID–19 vaccines under Medicare, Medicaid, and the Children’s Health Insurance Program, and for other purposes. 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; TABLE OF CONTENTS. 3 (a) SHORT TITLE.—This Act may be cited as the 4 ‘‘Vaccine And Coverage Certainty Act’’ or the ‘‘VACC 5 Act’’. 6 (b) TABLE OF CONTENTS.—The table of contents for 7 this Act is as follows: 8 Sec. 1. Short title; table of contents. VerDate Sep 11 2014 18:19 Aug 27, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6211 E:\BILLS\S4509.IS S4509 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 4509 IS TITLE I—ENSURING COVERAGE OF COVID–19 VACCINES Sec. 101. Ensuring affordability of federally funded COVID–19 vaccines under Medicare. Sec. 102. Mandatory coverage of COVID–19 vaccines under Medicaid and CHIP. Sec. 103. Inclusion of federally funded COVID–19 vaccines under Medicaid drug rebate program; coverage of COVID–19 vaccines under State pediatric vaccine distribution program. Sec. 104. Temporary enhanced Federal match for medical assistance for COVID–19 vaccines. TITLE II—ENSURING COVERAGE UNDER MEDICAID Sec. 201. Increased FMAP for medical assistance to newly eligible individuals. Sec. 202. Medicaid coverage for citizens of Freely Associated States. TITLE III—ENSURING COVERAGE IN THE MARKETPLACE Sec. 301. Disregard of additional unemployment compensation for purposes of premium tax credit and cost-sharing subsidies. TITLE I—ENSURING COVERAGE 1 OF COVID–19 VACCINES 2 SEC. 101. ENSURING AFFORDABILITY OF FEDERALLY 3 FUNDED COVID–19 VACCINES UNDER MEDI- 4 CARE. 5 (a) IN GENERAL.—Section 1833 of the Social Secu- 6 rity Act (42 U.S.C. 1395l) is amended— 7 (1) in subsection (a)(1)(B), by inserting ‘‘sub- 8 ject to subsection (dd)(1) (with respect to payment 9 for federally funded COVID–19 vaccines),’’ after 10 ‘‘1861(s)(10)(A),’’; and 11 (2) by adding at the end the following new sub- 12 section: 13 ‘‘(dd) ENSURING AFFORDABILITY OF FEDERALLY 14 FUNDED COVID–19 VACCINES.— 15 VerDate Sep 11 2014 18:19 Aug 27, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S4509.IS S4509 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 4509 IS ‘‘(1) INITIAL PAYMENT.—For purposes of sub- 1 section (a)(1)(B), the amount of charges that are 2 considered reasonable with respect to an applicable 3 COVID–19 vaccine during the first year that such 4 vaccine is administered under this part (referred to 5 in this subsection as the ‘initial payment year’) shall 6 not exceed the amount described in paragraph (3). 7 ‘‘(2) APPLICABLE COVID–19 VACCINE.— 8 ‘‘(A) IN GENERAL.—In this subsection, the 9 term ‘applicable COVID–19 vaccine’ means a 10 vaccine— 11 ‘‘(i) approved by the Food and Drug 12 Administration under section 351 of the 13 Public Health Service Act or authorized 14 for emergency use under section 564 of the 15 Federal Food, Drug, and Cosmetic Act for 16 immunization against COVID–19; and 17 ‘‘(ii) whose manufacturer was pro- 18 vided funding for research or development 19 of such vaccine or for the manufacture of 20 such vaccine under a contract with the 21 Federal Government (including the Bio- 22 defense Advanced Research and Develop- 23 ment Authority of the Department of 24 Health and Human Services) or under a 25 VerDate Sep 11 2014 18:19 Aug 27, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S4509.IS S4509 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 4509 IS Federal grant program using funds made 1 available under the Coronavirus Aid, Re- 2 lief, and Economic Security Act (Public 3 Law 116–136), or subsequently enacted 4 legislation. 5 ‘‘(B) NONAPPLICATION TO VACCINES PUR- 6 CHASED FOR FEDERAL DISTRIBUTION.—Such 7 term shall not include any doses of such vaccine 8 that are purchased under a Federal contract or 9 grant agreement described in paragraph (2)(B) 10 for Federal distribution. 11 ‘‘(3) AMOUNT DESCRIBED.—The amount de- 12 scribed in this paragraph, with respect to an applica- 13 ble COVID–19 vaccine, is the Federal procurement 14 cost per dose accounting for Federal costs under all 15 Federal contracts or grant agreements described in 16 paragraph (2)(B) for the initial supply order with 17 respect to such vaccine, not including the cost of any 18 option to buy future doses of such vaccine under 19 such contracts or agreements. 20 ‘‘(4) PAYMENT IN SUBSEQUENT YEARS.—For 21 provisions relating to payment for an applicable 22 COVID–19 vaccine in years after the initial payment 23 year, see section 1842(o)(1)(A)(iv) (relating to pay- 24 VerDate Sep 11 2014 18:19 Aug 27, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S4509.IS S4509 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 4509 IS ment amount equal to 95 percent of the average 1 wholesale price). 2 ‘‘(5) REBATE IF PRICE INCREASES FASTER 3 THAN INFLATION.— 4 ‘‘(A) IN GENERAL.—Subject to subpara- 5 graph (B), the Secretary shall establish a proc- 6 ess under which, with respect to an applicable 7 COVID–19 vaccine of a manufacturer, effective 8 beginning with the first year after the initial 9 payment year, if the amount of payment for the 10 vaccine under this part increases faster than in- 11 flation with respect to a rebate period specified 12 by the Secretary, the manufacturer of such vac- 13 cine shall, not later than 30 days after receipt 14 from the Secretary of the rebate amount for 15 such rebate period, provide a rebate to the Sec- 16 retary that is equal to the amount specified in 17 subparagraph (C) for such vaccine and rebate 18 period. 19 ‘‘(B) EXCEPTIONS.—The process estab- 20 lished under this paragraph shall provide for 21 the following exceptions with respect to an ap- 22 plicable COVID–19 vaccine of a manufacturer: 23 ‘‘(i) If the Secretary determines that 24 there are exceptional circumstances, such 25 VerDate Sep 11 2014 18:19 Aug 27, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S4509.IS S4509 pamtmann on DSKBC07HB2PROD with BILLS 6 •S 4509 IS as a substantial increase in development or 1 manufacturing costs due to circumstances 2 outside the control of the manufacturer. 3 ‘‘(ii) The manufacturer demonstrates, 4 to the satisfaction of the Secretary, that it 5 has significantly improved the clinical effi- 6 cacy or safety of such vaccine relative to 7 its clinical efficacy or safety when it was 8 first procured or contracted for by the 9 Federal Government. For purposes of the 10 preceding sentence, a manufacturer may 11 demonstrate the improved clinical efficacy 12 or safety of a particular COVID–19 vac- 13 cine according to a process established by 14 the Advisory Committee on Immunization 15 Practices at the Centers for Disease Con- 16 trol in coordination with the Food and 17 Drug Administration. The results of any 18 assessment under this clause with respect 19 to an applicable COVID–19 vaccine shall 20 be made public. 21 ‘‘(C) REBATE AMOUNT.—The amount of a 22 rebate under this subparagraph, with respect to 23 an applicable COVID–19 vaccine of a manufac- 24 turer, is the product of— 25 VerDate Sep 11 2014 18:19 Aug 27, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S4509.IS S4509 pamtmann on DSKBC07HB2PROD with BILLS 7 •S 4509 IS ‘‘(i) the total number of doses of such 1 vaccine administered during the rebate pe- 2 riod; and 3 ‘‘(ii) the amount (if any) by which— 4 ‘‘(I) the amount of payment for 5 the vaccine under this part during the 6 rebate period; exceeds 7 ‘‘(II) the inflation-adjusted pay- 8 ment amount determined under sub- 9 paragraph (D) of this paragraph for 10 such vaccine during the rebate period. 11 ‘‘(D) DETERMINATION OF INFLATION-AD- 12 JUSTED PAYMENT AMOUNT.—The inflation-ad- 13 justed payment amount determined under this 14 subparagraph for an applicable COVID–19 vac- 15 cine for a rebate period is— 16 ‘‘(i) the amount of payment for the 17 vaccine under this part during the initial 18 payment year as described in paragraph 19 (1); increased by 20 ‘‘(ii) the percentage by which the re- 21 bate period CPI–U (as defined in subpara- 22 graph (F)) for the rebate period exceeds 23 the benchmark period CPI–U (as defined 24 in subparagraph (E)). 25 VerDate Sep 11 2014 18:19 Aug 27, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S4509.IS S4509 pamtmann on DSKBC07HB2PROD with BILLS 8 •S 4509 IS ‘‘(E) BENCHMARK PERIOD CPI–U.—The 1 term ‘benchmark period CPI–U’ means the con- 2 sumer price index for all urban consumers 3 (United States city average) for the first cal- 4 endar quarter in the initial payment year. 5 ‘‘(F) REBATE PERIOD CPI–U.—The term 6 ‘rebate period CPI–U’ means, with respect to a 7 rebate period, the consumer price index for all 8 urban consumers (United States city average) 9 for the last month of the calendar quarter that 10 is two calendar quarters prior to the rebate pe- 11 riod. 12 ‘‘(G) PROVISION OF INFORMATION.—A 13 manufacturer of an applicable COVID–19 vac- 14 cine shall provide to the Secretary such infor- 15 mation, at such time and in such manner as the 16 Secretary specifies, as is needed to carry out 17 this paragraph. 18 ‘‘(H) REBATE DEPOSITS.—Amounts paid 19 as rebates under this paragraph shall be depos- 20 ited into the Federal Supplementary Medical 21 Insurance Trust Fund established under section 22 1841. 23 ‘‘(I) ENFORCEMENT.— 24 ‘‘(i) CIVIL MONEY PENALTY.— 25 VerDate Sep 11 2014 18:19 Aug 27, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S4509.IS S4509 pamtmann on DSKBC07HB2PROD with BILLS 9 •S 4509 IS ‘‘(I) IN GENERAL.—The Sec- 1 retary shall impose a civil money pen- 2 alty on a manufacturer that fails to 3 comply with the requirements under 4 this paragraph with respect to pro- 5 viding a rebate for an applicable 6 COVID–19 vaccine for a rebate period 7 for each such failure in an amount 8 equal to the sum of— 9 ‘‘(aa) the rebate amount 10 specified pursuant to subpara- 11 graph (C) for such vaccine for 12 such rebate period; and 13 ‘‘(bb) 25 percent of such 14 amount. 15 ‘‘(II) APPLICATION.—The provi- 16 sions of section 1128A (other than 17 subsections (a) (with respect to 18 amounts of penalties or additional as- 19 sessments) and (b)) shall apply to a 20 civil money penalty under this clause 21 in the same manner as such provi- 22 sions apply to a penalty or proceeding 23 under section 1128A(a). 24 VerDate Sep 11 2014 18:19 Aug 27, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S4509.IS S4509 pamtmann on DSKBC07HB2PROD with BILLS 10 •S 4509 IS ‘‘(ii) NO PAYMENT FOR MANUFACTUR- 1 ERS WHO FAIL TO PAY PENALTY.—If the 2 manufacturer of an applicable COVID–19 3 vaccine fails to pay a civil money penalty 4 under clause (i) with respect to the failure 5 to provide a rebate for an applicable 6 COVID–19 vaccine for a rebate period by 7 a date specified by the Secretary after the 8 imposition of such penalty, no payment 9 shall be available under this part for such 10 vaccine for calendar quarters beginning on 11 or after such date until the Secretary de- 12 termines the manufacturer has paid the 13 penalty due under such clause. 14 ‘‘(J) IMPLEMENTATION.—There shall be 15 no administrative or judicial review under sec- 16 tion 1869, section 1878, or otherwise, of the de- 17 termination of the rebate amount for an appli- 18 cable COVID–19 vaccine under subparagraph 19 (C), including the determination of— 20 ‘‘(i) the total number of COVID–19 21 vaccines administered during the rebate 22 period under subparagraph (C)(i); and 23 ‘‘(ii) the inflation-adjusted payment 24 amount under subparagraph (D).’’. 25 VerDate Sep 11 2014 18:19 Aug 27, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S4509.IS S4509 pamtmann on DSKBC07HB2PROD with BILLS 11 •S 4509 IS (b) CONFORMING AMENDMENT.—Section 1 1842(o)(1)(A)(iv) of the Social Security Act (42 U.S.C. 2 1395u(o)(1)(A)(iv)) is amended by striking ‘‘A vaccine’’ 3 and inserting ‘‘Subject to section 1833(dd)(1) (relating to 4 payment for an applicable COVID–19 vaccine during ini- 5 tial payment year), a vaccine’’. 6 SEC. 102. MANDATORY COVERAGE OF COVID–19 VACCINES 7 UNDER MEDICAID AND CHIP. 8 (a) MEDICAID.— 9 (1) IN GENERAL.—Section 1905(a)(4) of the 10 Social Security Act (42 U.S.C. 1396d(a)(4)) is 11 amended— 12 (A) by striking ‘‘and (D)’’ and inserting 13 ‘‘(D)’’; and 14 (B) by striking the semicolon at the end 15 and inserting ‘‘; and (E) a COVID–19 vaccine 16 licensed under section 351 of the Public Health 17 Service Act, or approved or authorized under 18 sections 505 or 564 of the Federal Food, Drug, 19 and Cosmetic Act, and administration of the 20 vaccine;’’. 21 (2) PROHIBITION OF COST SHARING.— 22 (A) IN GENERAL.—Subsections (a)(2) and 23 (b)(2) of section 1916 of the Social Security 24 Act (42 U.S.C. 1396o) are each amended— 25 VerDate Sep 11 2014 18:19 Aug 27, 2020 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S4509.IS S4509 pamtmann on DSKBC07HB2PROD with BILLS 12 •S 4509 IS (i) in subparagraph (F), by striking 1 ‘‘or’’ at the end; 2 (ii) in subparagraph (G), by striking 3 ‘‘; and’’ and inserting ‘‘, or’’; and 4 (iii) by adding at the end the fol- 5 lowing subparagraph: 6 ‘‘(H) a COVID–19 vaccine licensed under 7 section 351 of the Public Health Service Act, or 8 approved or authorized under sections 505 or 9 564 of the Federal Food, Drug, and Cosmetic 10 Act, and the administration of such vaccine; 11 and’’. 12 (B) APPLICATION TO ALTERNATIVE COST 13 SHARING.—Section 1916A(b)(3)(B) of the So- 14 cial Security Act (42 U.S.C. 1396o–1(b)(3)(B)) 15 is amended— 16 (i) in clause (xi), by striking ‘‘any 17 visit’’ and inserting ‘‘any service’’; and 18 (ii) by adding at the end the following 19 clause: 20 ‘‘(xii) A COVID–19 vaccine licensed 21 under section 351 of the Public Health 22 Service Act, or approved or authorized 23 under sections 505 or 564 of the Federal 24 VerDate Sep 11 2014 18:19 Aug 27, 2020 Jkt 099200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S4509.IS S4509 pamtmann on DSKBC07HB2PROD with BILLS 13 •S 4509 IS Food, Drug, and Cosmetic Act, and the 1 administration of such vaccine.’’. 2 (C) CLARIFICATION.—The amendments 3 made by this subsection shall apply with respect 4 to a State plan of a territory in the same man- 5 ner as the amendments apply to a State plan 6 of 1 of the 50 St [Text truncated for display. 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