Affordable Insulin for All Act

I 116TH CONGRESS 2D SESSION H. R. 5749 To amend title XI of the Social Security Act to establish the American Insulin Program to provide for lower prices for insulin drugs, to maintain effort throughout the insulin supply chain, and for other purposes. IN THE HOUSE OF REPRESENTATIVES FEBRUARY 4, 2020 Mr. CRIST introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the juris- diction of the committee concerned A BILL To amend title XI of the Social Security Act to establish the American Insulin Program to provide for lower prices for insulin drugs, to maintain effort throughout the insu- lin supply chain, 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. 3 This Act may be cited as the ‘‘Affordable Insulin for 4 All Act’’. 5 VerDate Sep 11 2014 03:14 Feb 05, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H5749.IH H5749 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 5749 IH SEC. 2. PROVIDING FOR LOWER PRICES FOR INSULIN 1 DRUGS. 2 Part A of title XI of the Social Security Act (42 3 U.S.C. 1301) is amended by adding at the end the fol- 4 lowing new section: 5 ‘‘SEC. 1150C. ESTABLISHMENT OF PROGRAM. 6 ‘‘(a) IN GENERAL.—The Secretary shall establish an 7 American Insulin Program (in this section referred to as 8 the ‘program’) by not later than 30 days after the date 9 of the enactment of this section. Under the program, the 10 Secretary shall enter into agreements described in sub- 11 section (b) with manufacturers and provide for the per- 12 formance of duties described in subsection (c). The Sec- 13 retary shall establish a model agreement for use under the 14 program by not later than 20 days after the date of the 15 enactment of this section, in consultation with manufac- 16 turers, and allow for comment on such model agreement. 17 ‘‘(b) TERMS OF AGREEMENT.— 18 ‘‘(1) IN GENERAL.— 19 ‘‘(A) AGREEMENT.—An agreement under 20 this section shall require the manufacturer to 21 provide applicable individuals access to Med- 22 icaid prices for insulin drugs of the manufac- 23 turer. 24 ‘‘(B) PROVISION OF DISCOUNTED PRICES 25 AS THE POINT-OF-SALE.— 26 VerDate Sep 11 2014 03:14 Feb 05, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5749.IH H5749 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 5749 IH ‘‘(i) IN GENERAL.—Subject to clause 1 (ii), such Medicaid prices shall be provided 2 to the applicable beneficiary at the phar- 3 macy or by the mail order service at the 4 point-of-sale of an insulin drug. 5 ‘‘(ii) CERTIFICATION OF 6 UNSUSTAINABLE REVENUES.— 7 ‘‘(I) IN GENERAL.—In the case 8 the Secretary submits to Congress a 9 certification that net revenues from 10 the sale of insulin drugs by manufac- 11 turers with an agreement under this 12 section is unsustainable because such 13 manufactures will be unable to meet 14 the demand for insulin drugs in the 15 United States, subject to subclause 16 (II), the Secretary may increase the 17 Medicaid price by 5 percent. 18 ‘‘(II) LIMITATION.—The Sec- 19 retary may not increase the Medicaid 20 price in accordance with subclause (I) 21 more than 3 times. 22 ‘‘(III) APPLICABILITY OF PRICE 23 INCREASE.—An increase to the Med- 24 icaid price of insulin drugs described 25 VerDate Sep 11 2014 03:14 Feb 05, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5749.IH H5749 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 5749 IH in subclause (I) shall apply to the sale 1 of insulin drugs 90 days after the 2 date of a certification described in 3 such subclause. 4 ‘‘(C) TIMING OF AGREEMENT.— 5 ‘‘(i) SPECIAL RULE FOR 2021.—In 6 order for an agreement with a manufac- 7 turer to be in effect under this section with 8 respect to the period beginning on January 9 1, 2021, and ending on December 31, 10 2021, the manufacturer shall enter into 11 such agreement not later than 30 days 12 after the date of the establishment of a 13 model agreement under subsection (a). 14 ‘‘(ii) 2022 AND SUBSEQUENT 15 YEARS.—In order for an agreement with a 16 manufacturer to be in effect under this 17 section with respect to plan year 2022 or 18 a subsequent plan year, the manufacturer 19 shall enter into such agreement (or such 20 agreement shall be renewed under para- 21 graph (4)(A)) not later than January 30 of 22 the preceding year. 23 ‘‘(2) PROVISION OF APPROPRIATE DATA.—Each 24 manufacturer with an agreement in effect under this 25 VerDate Sep 11 2014 03:14 Feb 05, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H5749.IH H5749 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 5749 IH section shall collect and have available appropriate 1 data, as determined by the Secretary, to ensure that 2 it can demonstrate to the Secretary compliance with 3 the requirements under the program. 4 ‘‘(3) COMPLIANCE WITH REQUIREMENTS FOR 5 ADMINISTRATION OF PROGRAM.—Each manufac- 6 turer with an agreement in effect under this section 7 shall comply with requirements imposed by the Sec- 8 retary or a third party with a contract under sub- 9 section (d)(3), as applicable, for purposes of admin- 10 istering the program, including any determination 11 under clause (i) of subsection (c)(1)(A) or proce- 12 dures established under such subsection (c)(1)(A). 13 ‘‘(4) LENGTH OF AGREEMENT.— 14 ‘‘(A) IN GENERAL.—An agreement under 15 this section shall be effective for an initial pe- 16 riod of not less than 18 months and shall be 17 automatically renewed for a period of not less 18 than 1 year unless terminated under subpara- 19 graph (B). 20 ‘‘(B) TERMINATION.— 21 ‘‘(i) BY THE SECRETARY.—The Sec- 22 retary may provide for termination of an 23 agreement under this section for a knowing 24 and willful violation of the requirements of 25 VerDate Sep 11 2014 03:14 Feb 05, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H5749.IH H5749 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 5749 IH the agreement or other good cause shown. 1 Such termination shall not be effective ear- 2 lier than 30 days after the date of notice 3 to the manufacturer of such termination. 4 The Secretary shall provide, upon request, 5 a manufacturer with a hearing concerning 6 such a termination, and such hearing shall 7 take place prior to the effective date of the 8 termination with sufficient time for such 9 effective date to be repealed if the Sec- 10 retary determines appropriate. 11 ‘‘(ii) BY A MANUFACTURER.—A man- 12 ufacturer may terminate an agreement 13 under this section for any reason. Any 14 such termination shall be effective, with re- 15 spect to a plan year— 16 ‘‘(I) if the termination occurs be- 17 fore January 30 of a plan year, as of 18 the day after the end of the plan year; 19 and 20 ‘‘(II) if the termination occurs on 21 or after January 30 of a plan year, as 22 of the day after the end of the suc- 23 ceeding plan year. 24 VerDate Sep 11 2014 03:14 Feb 05, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5749.IH H5749 kjohnson on DSK79L0C42PROD with BILLS 7 •HR 5749 IH ‘‘(iii) EFFECTIVENESS OF TERMI- 1 NATION.—Any termination under this sub- 2 paragraph shall not affect discounts for in- 3 sulin drugs of the manufacturer that are 4 due under the agreement before the effec- 5 tive date of its termination. 6 ‘‘(iv) NOTICE TO THIRD PARTY.—The 7 Secretary shall provide notice of such ter- 8 mination to a third party with a contract 9 under subsection (d)(3) within not less 10 than 30 days before the effective date of 11 such termination. 12 ‘‘(c) DUTIES DESCRIBED.—The duties described in 13 this subsection are the following: 14 ‘‘(1) ADMINISTRATION OF PROGRAM.—Admin- 15 istering the program, including— 16 ‘‘(A) the determination of the amount of 17 the Medicaid price of an insulin drug of a man- 18 ufacturer for applicable individuals in each 19 State; 20 ‘‘(B) except as provided in subparagraph 21 (C), the establishment of procedures under 22 which Medicaid prices are provided to applica- 23 ble individuals at pharmacies or by mail order 24 service at the point-of-sale of an insulin drug; 25 VerDate Sep 11 2014 03:14 Feb 05, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H5749.IH H5749 kjohnson on DSK79L0C42PROD with BILLS 8 •HR 5749 IH ‘‘(C) in the case where, during the period 1 beginning on January 1, 2022, and ending on 2 December 31, 2022, it is not practicable to pro- 3 vide such Medicaid prices at the point-of-sale 4 (as described in subparagraph (B)), the estab- 5 lishment of procedures to provide such Medicaid 6 prices as soon as practicable after the point-of- 7 sale; 8 ‘‘(D) the establishment of procedures to 9 ensure that, not later than the applicable num- 10 ber of calendar days after the dispensing of an 11 insulin drug by a pharmacy or mail order serv- 12 ice, the pharmacy or mail order service is reim- 13 bursed for an amount equal to the difference 14 between— 15 ‘‘(i) the negotiated price of the insulin 16 drug; and 17 ‘‘(ii) the Medicaid price of the insulin 18 drug; and 19 ‘‘(E) providing a reasonable dispute resolu- 20 tion mechanism to resolve disagreements be- 21 tween manufacturers, applicable individuals, 22 and the third party with a contract under sub- 23 section (d)(3). 24 ‘‘(2) MONITORING COMPLIANCE.— 25 VerDate Sep 11 2014 03:14 Feb 05, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H5749.IH H5749 kjohnson on DSK79L0C42PROD with BILLS 9 •HR 5749 IH ‘‘(A) IN GENERAL.—The Secretary shall 1 monitor compliance by a manufacturer with the 2 terms of an agreement under this section. 3 ‘‘(B) NOTIFICATION.—If a third party 4 with a contract under subsection (d)(3) deter- 5 mines that the manufacturer is not in compli- 6 ance with such agreement, the third party shall 7 notify the Secretary of such noncompliance for 8 appropriate enforcement under subsection (e). 9 ‘‘(3) COLLECTION OF DATA FROM STATE MED- 10 ICAID PROGRAMS.—The Secretary may collect appro- 11 priate data from each State Medicaid program under 12 title XIX in a timeframe that allows for Medicaid 13 prices to be provided for applicable drugs under this 14 section. 15 ‘‘(d) ADMINISTRATION.— 16 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 17 the Secretary shall provide for the implementation of 18 this section, including the performance of the duties 19 described in subsection (c). 20 ‘‘(2) LIMITATION.— 21 ‘‘(A) IN GENERAL.—Subject to subpara- 22 graph (B), in providing for such implementa- 23 tion, the Secretary shall not receive or dis- 24 VerDate Sep 11 2014 03:14 Feb 05, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H5749.IH H5749 kjohnson on DSK79L0C42PROD with BILLS 10 •HR 5749 IH tribute any funds of a manufacturer under the 1 program. 2 ‘‘(B) EXCEPTION.—The limitation under 3 subparagraph (A) shall not apply to the Sec- 4 retary with respect to insulin drugs dispensed 5 during the period beginning on January 1, 6 2022, and ending on December 31, 2022, but 7 only if the Secretary determines that the excep- 8 tion to such limitation under this subparagraph 9 is necessary in order for the Secretary to begin 10 implementation of this section and provide ap- 11 plicable beneficiaries timely access to Medicaid 12 prices during such period. 13 ‘‘(3) CONTRACT WITH THIRD PARTIES.—The 14 Secretary shall enter into a contract with 1 or more 15 third parties to administer the requirements estab- 16 lished by the Secretary in order to carry out this 17 section. At a minimum, the contract with a third 18 party under the preceding sentence shall require 19 that the third party— 20 ‘‘(A) receive and transmit information be- 21 tween the Secretary, manufacturers, and other 22 individuals or entities the Secretary determines 23 appropriate; 24 VerDate Sep 11 2014 03:14 Feb 05, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H5749.IH H5749 kjohnson on DSK79L0C42PROD with BILLS 11 •HR 5749 IH ‘‘(B) receive, distribute, or facilitate the 1 distribution of funds of manufacturers to ap- 2 propriate individuals or entities in order to 3 meet the obligations of manufacturers under 4 agreements under this section; 5 ‘‘(C) provide adequate and timely informa- 6 tion to manufacturers, consistent with the 7 agreement with the manufacturer under this 8 section, as necessary for the manufacturer to 9 fulfill its obligations under this section; and 10 ‘‘(D) permit manufacturers to conduct 11 periodic audits, directly or through contracts, of 12 the data and information used by the third 13 party to determine discounts for insulin drugs 14 of the manufacturer under the program. 15 ‘‘(4) PERFORMANCE REQUIREMENTS.—The 16 Secretary shall establish performance requirements 17 for a third party with a contract under paragraph 18 (3) and safeguards to protect the independence and 19 integrity of the activities carried out by the third 20 party under the program under this section. 21 ‘‘(5) IMPLEMENTATION.—The Secretary may 22 implement the program under this section by pro- 23 gram instruction or otherwise. 24 VerDate Sep 11 2014 03:14 Feb 05, 2020 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H5749.IH H5749 kjohnson on DSK79L0C42PROD with BILLS 12 •HR 5749 IH ‘‘(6) ADMINISTRATION.—Chapter 35 of title 44, 1 United States Code, shall not apply to the program 2 under this section. 3 ‘‘(e) ENFORCEMENT.— 4 ‘‘(1) AUDITS.—Each manufacturer with an 5 agreement in effect under this section shall be sub- 6 ject to periodic audit by the Secretary. 7 ‘‘(2) CIVIL MONETARY PENALTY.— 8 ‘‘(A) IN GENERAL.—The Secretary shall 9 impose a civil money penalty on a manufacturer 10 that fails to provide individuals Medicaid prices 11 for insulin drugs of the manufacturer in accord- 12 ance with such agreement for each such failure 13 in an amount the Secretary determines is com- 14 mensurate with the sum of— 15 ‘‘(i) the amount that the manufac- 16 turer would have paid with respect to such 17 discounts under the agreement, which will 18 then be used to pay the discounts which 19 the manufacturer had failed to provide; 20 and 21 ‘‘(ii) 25 percent of such amount. 22 ‘‘(B) APPLICATION.—The provisions of 23 section 1128A (other than subsections (a) and 24 (b)) shall apply to a civil money penalty under 25 VerDate Sep 11 2014 03:14 Feb 05, 2020 Jkt 099200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H5749.IH H5749 kjohnson on DSK79L0C42PROD with BILLS 13 •HR 5749 IH this paragraph in the same manner as such 1 provisions apply to a penalty or proceeding 2 under section 1128A(a). 3 ‘‘(f) DEFINITI [Text truncated for display. 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