I 

118TH CONGRESS 

1ST SESSION H. R. 1352 

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 3, 2023 

Mr. HUDSON 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 jurisdiction 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 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 2023’’. 


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1 SEC. 2. DEMONSTRATION PROJECT TO INCREASE ACCESS 

2 TO BIOSIMILAR BIOLOGICAL PRODUCTS 

3 UNDER THE MEDICARE PROGRAM. 

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

5 year after the date of the enactment of this Act, the Sec6 retary of Health and Human Services shall establish and 

7 implement a 3-year nationwide demonstration project 

8 under part B of title XVIII of the Social Security Act to 

9 evaluate the benefits of providing a shared savings pay10 ment for biosimilar biological products furnished under 

11 such part. 

12 (b) PARTICIPATION.— 

13 (1) IN GENERAL.—Participation under the 

14 demonstration project shall be voluntary, and a par15 ticipating provider may terminate participation at 

16 any time and the Secretary may terminate the par17 ticipation of such a provider at any time. 

18 (2) APPLICATION AND SELECTION.—To partici19 pate under the demonstration project, an eligible 

20 provider shall submit to the Secretary an application 

21 in such form and manner and containing such infor22 mation as specified by the Secretary. Each eligible 

23 provider who submits such an application shall be 

24 selected by the Secretary for participation under the 

25 demonstration project. 


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1 (3) CLARIFICATION.—Participation under the 

2 demonstration project shall not preclude eligible pro3 viders from also participating in any model author4 ized under section 1115A of the Social Security Act 

5 (42 U.S.C. 1315a), including the Oncology Care 

6 Model and Oncology Care First Model, or impact eli7 gible providers metrics or expenditures within other 

8 models 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 biosimlar biological product only if such prod12 uct is covered under part B of title XVIII of the Social 

13 Security Act and such payment shall be made in the same 

14 manner as payment is provided for such a product under 

15 such part. 

16 (d) ADDITIONAL PAYMENT.— 

17 (1) IN GENERAL.—Under the demonstration 

18 project, subject to paragraph (3), in addition to the 

19 payment that would otherwise be made under part 

20 B of title XVIII of the Social Security Act for a bio21 similar biological product furnished or dispensed by 

22 a participating provider to a Medicare beneficiary, 

23 there shall be made an additional payment, in an 

24 amount determined by the Secretary, that is based 

25 on the difference, if any, (or portion of such difVerDate Sep 11 2014 04:55 Mar 17, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1352.IH H1352

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1 ference) between the costs to the provider in fur2 nishing the biosimilar biological product and the 

3 costs to the provider if the provider had furnished 

4 the reference biological product. 

5 (2) NO INCREASE TO MEDICARE COINSUR6 ANCE.—The additional payment described under 

7 paragraph (1) shall not increase a Medicare bene8 ficiary’s cost-sharing liability, as described in section 

9 1833 of the Social Security Act (42 U.S.C. 1395l). 

10 (3) EXCEPTION.—An eligible provider may only 

11 receive the additional payment described in para12 graph (1), with respect to a biosimilar biological 

13 product, if the payment amount under section 

14 1847A of the Social Security Act (42 U.S.C. 

15 1395w–3a) for such product is less than the pay16 ment amount under part B of title XVIII of such 

17 Act for the reference biological product. 

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

19 such requirements of title XVIII of the Social Security Act 

20 as may be necessary to carry out the demonstration 

21 project, except the Secretary may not increase the cost22 sharing that would otherwise, without application of this 

23 section, be applied to an individual under section 1833 of 

24 the Social Security Act (42 U.S.C. 1395l). 

25 (f) REPORTS.— 


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1 (1) INTERIM EVALUATION AND REPORT.—Not 

2 later than 3 years after the date of enactment of 

3 this Act, the Secretary shall submit to Congress a 

4 report that contains an analysis of the appropriate5 ness of expanding or extending the demonstration 

6 project and, to the extent such analysis determines 

7 such an expansion or extension appropriate, rec8 ommendations for such expansion or extension, re9 spectively. 

10 (2) FINAL EVALUATION AND REPORT.—Not 

11 later than one year after the date of completion of 

12 the demonstration project, the Secretary shall sub13 mit to Congress a report that contains a final anal14 ysis of the project and recommendations described in 

15 paragraph (1). 

16 (g) DEFINITIONS.—In this section: 

17 (1) DEMONSTRATION PROJECT.—The term 

18 ‘‘demonstration project’’ means the demonstration 

19 project conducted under this Act. 

20 (2) BIOSIMILAR BIOLOGICAL PRODUCT.—The 

21 term ‘‘biosimilar biological product’’ means a biologi22 cal product approved under an abbreviated applica23 tion for a license of a biological product that relies 

24 in part on data or information in an application for 


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1 another biological product licensed under section 351 

2 of the Public Health Service Act (42 U.S.C. 262). 

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

4 provider’’ means a provider of services or supplier 

5 that is eligible to receive payment under part B of 

6 title XVIII of the Social Security Act for furnishing 

7 or dispensing biosimilar biological products. 

8 (4) MEDICARE BENEFICIARY.—The term 

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

10 enrolled for benefits under part B of title XVIII of 

11 the Social Security Act. 

12 (5) PARTICIPATING PROVIDER.—The term 

13 ‘‘participating provider’’ means an eligible provider 

14 that has been selected for participation under the 

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

16 whom such participation has not been terminated. 

17 (6) REFERENCE BIOLOGICAL PRODUCT.—The 

18 term ‘‘reference biological product’’ means the bio19 logical product licensed under section 351 of the 

20 Public Health Service Act (42 U.S.C. 262) that is 

21 referred to in the application described in paragraph 

22 (2) of the biosimilar biological product. 

Æ 


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