Increasing Access to Biosimilars Act of 2021

II 117TH CONGRESS 1ST SESSION S. 1427 To establish a demonstration project to increase access to biosimilar biological products under the Medicare program. IN THE SENATE OF THE UNITED STATES APRIL 28, 2021 Mr. CORNYN (for himself and Mr. BENNET) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To establish a demonstration project to increase access to biosimilar biological products under the Medicare program. 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 2021’’. 5 SEC. 2. DEMONSTRATION PROJECT TO INCREASE ACCESS 6 TO BIOSIMILAR BIOLOGICAL PRODUCTS 7 UNDER THE MEDICARE PROGRAM. 8 (a) ESTABLISHMENT.—Beginning not later than 1 9 year after the date of enactment of this Act, the Secretary 10 VerDate Sep 11 2014 03:10 May 22, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1427.IS S1427 kjohnson on DSK79L0C42PROD with BILLS 2 •S 1427 IS shall establish and implement a 5-year nationwide dem- 1 onstration project under part B of title XVIII of the Social 2 Security Act (42 U.S.C. 1395j et seq.) to evaluate the ben- 3 efits of providing a shared savings payment for biosimilar 4 biological products furnished under such part. At the dis- 5 cretion of the Secretary, the demonstration project may 6 be extended for an additional 2 years past the initial 5- 7 year period. 8 (b) PARTICIPATION.— 9 (1) IN GENERAL.—Participation in the dem- 10 onstration project shall be voluntary and a partici- 11 pating provider may terminate participation at any 12 time and the Secretary may terminate the participa- 13 tion of such a provider at any time for failure to 14 comply with the requirements of the demonstration 15 project. 16 (2) APPLICATION AND SELECTION.—To partici- 17 pate in the demonstration project, an eligible pro- 18 vider shall submit to the Secretary an application in 19 such form and manner and containing such informa- 20 tion as specified by the Secretary. Each eligible pro- 21 vider who submits such an application shall be se- 22 lected by the Secretary for participation under the 23 demonstration project. 24 VerDate Sep 11 2014 03:10 May 22, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1427.IS S1427 kjohnson on DSK79L0C42PROD with BILLS 3 •S 1427 IS (3) PARTICIPATION IN INNOVATION CENTER 1 MODELS.—Participation in the demonstration 2 project shall not preclude an eligible provider from 3 also participating in any model authorized under 4 section 1115A of the Social Security Act (42 U.S.C. 5 1315a), including the Oncology Care Model and the 6 Oncology Care First Model, or impact metrics or ex- 7 penditures with respect to an eligible provider under 8 any model authorized under such section. 9 (c) COVERAGE.—Except as otherwise provided in this 10 section, payment may be made under the demonstration 11 project for a biosimilar biological product only if such 12 product is covered under part B of title XVIII of the So- 13 cial Security Act (42 U.S.C. 1395j et seq.) and such pay- 14 ment shall be made in the same manner as payment is 15 provided for such a product under such part. 16 (d) ADDITIONAL PAYMENT.— 17 (1) IN GENERAL.—Subject to paragraphs (2) 18 and (3), in addition to the amount of payment that 19 would otherwise be made under part B of title XVIII 20 of the Social Security Act (42 U.S.C. 1395j et seq.) 21 for a biosimilar biological product furnished or dis- 22 pensed by a participating provider to a Medicare 23 beneficiary under the demonstration project, there 24 shall be made an additional payment, in an amount 25 VerDate Sep 11 2014 03:10 May 22, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1427.IS S1427 kjohnson on DSK79L0C42PROD with BILLS 4 •S 1427 IS determined by the Secretary, that reflects a portion 1 of any difference between such amount of payment 2 under such part, as compared to the amount of pay- 3 ment that would have been made under such part if 4 the reference biological product had been furnished 5 or dispensed to the beneficiary. 6 (2) MEDICARE BENEFICIARY COINSURANCE LI- 7 ABILITY.—The additional payment provided under 8 paragraph (1) shall not be taken into account when 9 determining the amount of coinsurance under sec- 10 tion 1833(a)(1)(S) of the Social Security Act (42 11 U.S.C. 1395l(a)(1)(S)) for a biosimilar biological 12 product furnished or dispensed to a Medicare bene- 13 ficiary by a participating provider under the dem- 14 onstration project. The Secretary may use a portion 15 of the difference described in such paragraph to 16 waive or reduce the amount of coinsurance otherwise 17 applicable under such section for such a biosimilar 18 biological. 19 (3) EXCEPTION TO ADDITIONAL PAYMENT.—A 20 participating provider may only receive the addi- 21 tional payment described in paragraph (1) with re- 22 spect to a biosimilar biological product furnished or 23 dispensed by the participating provider to a Medi- 24 care beneficiary under the demonstration project, if 25 VerDate Sep 11 2014 03:10 May 22, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1427.IS S1427 kjohnson on DSK79L0C42PROD with BILLS 5 •S 1427 IS the amount of payment determined under section 1 1847A of the Social Security Act (42 U.S.C. 2 1395w–3a) for the biosimilar biologic product is less 3 than the amount of payment determined under such 4 section for the reference biological product. 5 (e) WAIVER AUTHORITY.—The Secretary may waive 6 such requirements of titles XI and XVIII of the Social 7 Security Act (42 U.S.C. 1301 et seq., 1395 et seq.) as 8 may be necessary to carry out the demonstration project. 9 (f) DATA COLLECTION.— 10 (1) IN GENERAL.—The Secretary shall collect 11 data on the sex, race, ethnicity, and geographic and 12 socioeconomic characteristics of Medicare bene- 13 ficiaries to whom a biosimilar biological product is 14 furnished or dispensed by a participating provider 15 under the demonstration project. 16 (2) CONSIDERATION.—The Secretary shall take 17 into account data collected under paragraph (1) in 18 evaluating the demonstration project in each of the 19 reports submitted under subsection (g). 20 (g) REPORTS.— 21 (1) INTERIM EVALUATION AND REPORT.—Not 22 later than 3 years after the date of enactment of 23 this Act, the Secretary shall submit to Congress a 24 report that contains an analysis of the appropriate- 25 VerDate Sep 11 2014 03:10 May 22, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1427.IS S1427 kjohnson on DSK79L0C42PROD with BILLS 6 •S 1427 IS ness of expanding or extending the demonstration 1 project and, to the extent such analysis determines 2 such an expansion or extension appropriate, rec- 3 ommendations for such expansion or extension, re- 4 spectively. 5 (2) EVALUATION AND REPORT.—Not later than 6 1 year after the date of completion of the dem- 7 onstration project, the Secretary shall submit to 8 Congress a report that contains a final analysis of 9 the project and recommendations described in para- 10 graph (1). 11 (h) DEFINITIONS.—In this section: 12 (1) BIOSIMILAR BIOLOGICAL PRODUCT.—The 13 term ‘‘biosimilar biological product’’ has the mean- 14 ing given that term in section 1847A(c)(6)(H) of the 15 Social Security Act (42 U.S.C. 1395w–3a(c)(6)(H)). 16 (2) DEMONSTRATION PROJECT.—The term 17 ‘‘demonstration project’’ means the demonstration 18 project conducted under this section. 19 (3) ELIGIBLE PROVIDER.—The term ‘‘eligible 20 provider’’ means a provider of services or supplier 21 that is eligible to receive payment under part B of 22 title XVIII of the Social Security Act (42 U.S.C. 23 1395j et seq.) for furnishing or dispensing a bio- 24 similar biological product. 25 VerDate Sep 11 2014 03:10 May 22, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1427.IS S1427 kjohnson on DSK79L0C42PROD with BILLS 7 •S 1427 IS (4) MEDICARE BENEFICIARY.—The term 1 ‘‘Medicare beneficiary’’ means an individual who is 2 enrolled for benefits under such part. 3 (5) PARTICIPATING PROVIDER.—The term 4 ‘‘participating provider’’ means an eligible provider 5 that has been selected for participation under the 6 project under subsection (b)(2) and with respect to 7 whom such participation has not been terminated. 8 (6) REFERENCE BIOLOGICAL PRODUCT.—The 9 term ‘‘reference biological product’’ has the meaning 10 given that term in section 1847A(c)(6)(I) of the So- 11 cial Security Act (42 U.S.C. 1395w–3a(c)(6)(I)). 12 (7) SECRETARY.—The term ‘‘Secretary’’ means 13 the Secretary of Health and Human Services. 14 Æ VerDate Sep 11 2014 03:10 May 22, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\S1427.IS S1427 kjohnson on DSK79L0C42PROD with BILLS