II 

116TH CONGRESS 

2D SESSION S. 4134 

To establish a demonstration project to increase access to biosimilar biological 

products under the Medicare program. 

IN THE SENATE OF THE UNITED STATES 

JULY 1, 2020 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Increasing Access to 

5 Biosimilars Act of 2020’’. 

6 SEC. 2. DEMONSTRATION PROJECT TO INCREASE ACCESS 

7 TO BIOSIMILAR BIOLOGICAL PRODUCTS 

8 UNDER THE MEDICARE PROGRAM. 

9 (a) ESTABLISHMENT.—Beginning not later than 1 

10 year after the date of enactment of this Act, the Secretary 


pbinns on DSKJLVW7X2PROD with BILLS
2 

•S 4134 IS

1 shall establish and implement a 5-year nationwide dem2 onstration project under part B of title XVIII of the Social 

3 Security Act (42 U.S.C. 1395j et seq.) to evaluate the ben4 efits of providing a shared savings payment for biosimilar 

5 biological products furnished under such part. At the dis6 cretion of the Secretary, the demonstration project may 

7 be extended for an additional 2 years past the initial 5- 

8 year period. 

9 (b) PARTICIPATION.— 

10 (1) IN GENERAL.—Participation in the dem11 onstration project shall be voluntary and a partici12 pating provider may terminate participation at any 

13 time and the Secretary may terminate the participa14 tion of such a provider at any time for failure to 

15 comply with the requirements of the demonstration 

16 project. 

17 (2) APPLICATION AND SELECTION.—To partici18 pate in the demonstration project, an eligible pro19 vider shall submit to the Secretary an application in 

20 such form and manner and containing such informa21 tion as specified by the Secretary. Each eligible pro22 vider who submits such an application shall be se23 lected by the Secretary for participation under the 

24 demonstration project. 


pbinns on DSKJLVW7X2PROD with BILLS
3 

•S 4134 IS

1 (3) PARTICIPATION IN INNOVATION CENTER

2 MODELS.—Participation in the demonstration 

3 project shall not preclude an eligible provider from 

4 also participating in any model authorized under 

5 section 1115A of the Social Security Act (42 U.S.C. 

6 1315a), including the Oncology Care Model and the 

7 Oncology Care First Model, or impact metrics or ex8 penditures with respect to an eligible provider under 

9 any model authorized under such section. 

10 (c) COVERAGE.—Except as otherwise provided in this 

11 section, payment may be made under the demonstration 

12 project for a biosimilar biological product only if such 

13 product is covered under part B of title XVIII of the So14 cial Security Act (42 U.S.C. 1395j et seq.) and such pay15 ment shall be made in the same manner as payment is 

16 provided for such a product under such part. 

17 (d) ADDITIONAL PAYMENT.— 

18 (1) IN GENERAL.—Subject to paragraphs (2) 

19 and (3), in addition to the amount of payment that 

20 would otherwise be made under part B of title XVIII 

21 of the Social Security Act (42 U.S.C. 1395j et seq.) 

22 for a biosimilar biological product furnished or dis23 pensed by a participating provider to a Medicare 

24 beneficiary under the demonstration project, there 

25 shall be made an additional payment, in an amount 


pbinns on DSKJLVW7X2PROD with BILLS
4 

•S 4134 IS

1 determined by the Secretary, that reflects a portion 

2 of any difference between such amount of payment 

3 under such part, as compared to the amount of pay4 ment that would have been made under such part if 

5 the reference biological product had been furnished 

6 or dispensed to the beneficiary. 

7 (2) MEDICARE BENEFICIARY COINSURANCE LI8 ABILITY.—The additional payment provided under 

9 paragraph (1) shall not be taken into account when 

10 determining the amount of coinsurance under sec11 tion 1833(a)(1)(S) of the Social Security Act (42 

12 U.S.C. 1395l(a)(1)(S)) for a biosimilar biological 

13 product furnished or dispensed to a Medicare bene14 ficiary by a participating provider under the dem15 onstration project. The Secretary may use a portion 

16 of the difference described in such paragraph to 

17 waive or reduce the amount of coinsurance otherwise 

18 applicable under such section for such a biosimilar 

19 biological. 

20 (3) EXCEPTION TO ADDITIONAL PAYMENT.—A 

21 participating provider may only receive the addi22 tional payment described in paragraph (1) with re23 spect to a biosimilar biological product furnished or 

24 dispensed by the participating provider to a Medi25 care beneficiary under the demonstration project, if 


pbinns on DSKJLVW7X2PROD with BILLS
5 

•S 4134 IS

1 the amount of payment determined under section 

2 1847A of the Social Security Act (42 U.S.C. 

3 1395w–3a) for the biosimilar biologic product is less 

4 than the amount of payment determined under such 

5 section for the reference biological product. 

6 (e) WAIVER AUTHORITY.—The Secretary may waive 

7 such requirements of titles XI and XVIII of the Social 

8 Security Act (42 U.S.C. 1301 et seq., 1395 et seq.) as 

9 may be necessary to carry out the demonstration project. 

10 (f) DATA COLLECTION.— 

11 (1) IN GENERAL.—The Secretary shall collect 

12 data on the sex, race, ethnicity, and geographic and 

13 socioeconomic characteristics of Medicare bene14 ficiaries to whom a biosimilar biological product is 

15 furnished or dispensed by a participating provider 

16 under the demonstration project. 

17 (2) CONSIDERATION.—The Secretary shall take 

18 into account data collected under paragraph (1) in 

19 evaluating the demonstration project in each of the 

20 reports submitted under subsection (g). 

21 (g) REPORTS.— 

22 (1) INTERIM EVALUATION AND REPORT.—Not 

23 later than 3 years after the date of enactment of 

24 this Act, the Secretary shall submit to Congress a 

25 report that contains an analysis of the appropriateVerDate Sep 11 2014 00:55 Jul 12, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S4134.IS S4134

pbinns on DSKJLVW7X2PROD with BILLS
6 

•S 4134 IS

1 ness of expanding or extending the demonstration 

2 project and, to the extent such analysis determines 

3 such an expansion or extension appropriate, rec4 ommendations for such expansion or extension, re5 spectively. 

6 (2) EVALUATION AND REPORT.—Not later than 

7 1 year after the date of completion of the dem8 onstration project, the Secretary shall submit to 

9 Congress a report that contains a final analysis of 

10 the project and recommendations described in para11 graph (1). 

12 (h) DEFINITIONS.—In this section: 

13 (1) BIOSIMILAR BIOLOGICAL PRODUCT.—The 

14 term ‘‘biosimilar biological product’’ has the mean15 ing given that term in section 1847A(c)(6)(H) of the 

16 Social Security Act (42 U.S.C. 1395w–3a(c)(6)(H)). 

17 (2) DEMONSTRATION PROJECT.—The term 

18 ‘‘demonstration project’’ means the demonstration 

19 project conducted under this section. 

20 (3) ELIGIBLE PROVIDER.—The term ‘‘eligible 

21 provider’’ means a provider of services or supplier 

22 that is eligible to receive payment under part B of 

23 title XVIII of the Social Security Act (42 U.S.C. 

24 1395j et seq.) for furnishing or dispensing a bio25 similar biological product. 


pbinns on DSKJLVW7X2PROD with BILLS
7 

•S 4134 IS

1 (4) MEDICARE BENEFICIARY.—The term 

2 ‘‘Medicare beneficiary’’ means an individual who is 

3 enrolled for benefits under such part. 

4 (5) PARTICIPATING PROVIDER.—The term 

5 ‘‘participating provider’’ means an eligible provider 

6 that has been selected for participation under the 

7 project under subsection (b)(2) and with respect to 

8 whom such participation has not been terminated. 

9 (6) REFERENCE BIOLOGICAL PRODUCT.—The 

10 term ‘‘reference biological product’’ has the meaning 

11 given that term in section 1847A(c)(6)(I) of the So12 cial Security Act (42 U.S.C. 1395w–3a(c)(6)(I)). 

13 (7) SECRETARY.—The term ‘‘Secretary’’ means 

14 the Secretary of Health and Human Services. 

Æ 


pbinns on DSKJLVW7X2PROD with BILLS