Increasing Access to Biosimilars Act of 2020

I 116TH CONGRESS 2D SESSION H. R. 6179 To require the Secretary of Health and Human Services to establish a demonstration project to increase access to biosimilar biological products under the Medicare program. IN THE HOUSE OF REPRESENTATIVES MARCH 10, 2020 Mr. CA´RDENAS (for himself, Mr. HUDSON, Ms. CRAIG, and Mr. FITZPATRICK) introduced the following bill; which was referred to the Committee on En- ergy 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 jurisdic- tion of the committee concerned A BILL To require the Secretary of Health and Human Services to establish a demonstration project to increase access to biosimilar biological products under the Medicare pro- gram. 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 ‘‘Increasing Access to 4 Biosimilars Act of 2020’’. 5 VerDate Sep 11 2014 04:13 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H6179.IH H6179 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 6179 IH SEC. 2. DEMONSTRATION PROJECT TO INCREASE ACCESS 1 TO BIOSIMILAR BIOLOGICAL PRODUCTS 2 UNDER THE MEDICARE PROGRAM. 3 (a) ESTABLISHMENT.—Beginning not later than 1 4 year after the date of the enactment of this Act, the Sec- 5 retary of Health and Human Services shall establish and 6 implement a 3-year nationwide demonstration project 7 under part B of title XVIII of the Social Security Act to 8 evaluate the benefits of providing a shared savings pay- 9 ment for biosimilar biological products furnished under 10 such part. 11 (b) PARTICIPATION.— 12 (1) IN GENERAL.—Participation under the 13 demonstration project shall be voluntary, and a par- 14 ticipating provider may terminate participation at 15 any time and the Secretary may terminate the par- 16 ticipation of such a provider at any time. 17 (2) APPLICATION AND SELECTION.—To partici- 18 pate under the demonstration project, an eligible 19 provider shall submit to the Secretary an application 20 in such form and manner and containing such infor- 21 mation as specified by the Secretary. Each eligible 22 provider who submits such an application shall be 23 selected by the Secretary for participation under the 24 demonstration project. 25 VerDate Sep 11 2014 04:13 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H6179.IH H6179 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 6179 IH (3) CLARIFICATION.—Participation under the 1 demonstration project shall not preclude eligible pro- 2 viders from also participating in any model author- 3 ized under section 1115A of the Social Security Act 4 (42 U.S.C. 1315a), including the Oncology Care 5 Model and Oncology Care First Model, or impact eli- 6 gible providers metrics or expenditures within other 7 models authorized under such section. 8 (c) COVERAGE.—Except as otherwise provided in this 9 section, payment may be made under the demonstration 10 project for a biosimlar biological product only if such prod- 11 uct is covered under part B of title XVIII of the Social 12 Security Act and such payment shall be made in the same 13 manner as payment is provided for such a product under 14 such part. 15 (d) ADDITIONAL PAYMENT.— 16 (1) IN GENERAL.—Under the demonstration 17 project, subject to paragraph (3), in addition to the 18 payment that would otherwise be made under part 19 B of title XVIII of the Social Security Act for a bio- 20 similar biological product furnished or dispensed by 21 a participating provider to a Medicare beneficiary, 22 there shall be made an additional payment, in an 23 amount determined by the Secretary, that is based 24 on the difference, if any, (or portion of such dif- 25 VerDate Sep 11 2014 04:13 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H6179.IH H6179 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 6179 IH ference) between the costs to the provider in fur- 1 nishing the biosimilar biological product and the 2 costs to the provider if the provider had furnished 3 the reference biological product. 4 (2) NO INCREASE TO MEDICARE COINSUR- 5 ANCE.—The additional payment described under 6 paragraph (1) shall not increase a Medicare bene- 7 ficiary’s cost-sharing liability, as described in section 8 1833 of the Social Security Act (42 U.S.C. 1395l). 9 (3) EXCEPTION.—An eligible provider may only 10 receive the additional payment described in para- 11 graph (1), with respect to a biosimilar biological 12 product, if the payment amount under section 13 1847A of the Social Security Act (42 U.S.C. 14 1395w–3a) for such product is less than the pay- 15 ment amount under part B of title XVIII of such 16 Act for the reference biological product. 17 (e) WAIVER AUTHORITY.—The Secretary may waive 18 such requirements of title XVIII of the Social Security Act 19 as may be necessary to carry out the demonstration 20 project, except the Secretary may not increase the cost- 21 sharing that would otherwise, without application of this 22 section, be applied to an individual under section 1833 of 23 the Social Security Act (42 U.S.C. 1395l). 24 (f) REPORTS.— 25 VerDate Sep 11 2014 04:13 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H6179.IH H6179 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 6179 IH (1) INTERIM EVALUATION AND REPORT.—Not 1 later than 3 years after the date of enactment of 2 this Act, the Secretary shall submit to Congress a 3 report that contains an analysis of the appropriate- 4 ness of expanding or extending the demonstration 5 project and, to the extent such analysis determines 6 such an expansion or extension appropriate, rec- 7 ommendations for such expansion or extension, re- 8 spectively. 9 (2) FINAL EVALUATION AND REPORT.—Not 10 later than one year after the date of completion of 11 the demonstration project, the Secretary shall sub- 12 mit to Congress a report that contains a final anal- 13 ysis of the project and recommendations described in 14 paragraph (1). 15 (g) DEFINITIONS.—In this section: 16 (1) DEMONSTRATION PROJECT.—The term 17 ‘‘demonstration project’’ means the demonstration 18 project conducted under this Act. 19 (2) BIOSIMILAR BIOLOGICAL PRODUCT.—The 20 term ‘‘biosimilar biological product’’ means a biologi- 21 cal product approved under an abbreviated applica- 22 tion for a license of a biological product that relies 23 in part on data or information in an application for 24 VerDate Sep 11 2014 04:13 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H6179.IH H6179 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 6179 IH another biological product licensed under section 351 1 of the Public Health Service Act (42 U.S.C. 262) . 2 (3) ELIGIBLE PROVIDER.—The term ‘‘eligible 3 provider’’ means a provider of services or supplier 4 that is eligible to receive payment under part B of 5 title XVIII of the Social Security Act for furnishing 6 or dispensing biosimilar biological products. 7 (4) MEDICARE BENEFICIARY.—The term 8 ‘‘Medicare beneficiary’’ means an individual who is 9 enrolled for benefits under part B of title XVIII of 10 the Social Security Act. 11 (5) PARTICIPATING PROVIDER.—The term 12 ‘‘participating provider’’ means an eligible provider 13 that has been selected for participation under the 14 project under subsection (b)(2) and with respect to 15 whom such participation has not been terminated. 16 (6) REFERENCE BIOLOGICAL PRODUCT.—The 17 term ‘‘reference biological product’’ means the bio- 18 logical product licensed under section 351 of the 19 Public Health Service Act (42 U.S.C. 262) that is 20 referred to in the application described in paragraph 21 (2) of the biosimilar biological product. 22 Æ VerDate Sep 11 2014 04:13 Mar 17, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\H6179.IH H6179 kjohnson on DSK79L0C42PROD with BILLS