I 

116TH CONGRESS 

1ST SESSION H. R. 4455 

To amend title XVIII of the Social Security Act to provide for a temporary 

payment increase under the Medicare program for certain biosimilar 

biological products to encourage the development and use of such products. 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 20, 2019 

Mr. SCHRADER (for himself and Mr. GIANFORTE) 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 amend title XVIII of the Social Security Act to provide 

for a temporary payment increase under the Medicare 

program for certain biosimilar biological products to encourage the development and use of such products. 

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 ‘‘Bolstering Innovative 

5 Options to Save Immediately on Medicines Act’’ or the 

6 ‘‘BIOSIM Act’’. 


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1 SEC. 2. TEMPORARY INCREASE IN MEDICARE PART B PAY2 MENT FOR CERTAIN BIOSIMILAR BIOLOGI3 CAL PRODUCTS. 

4 Section 1847A(b)(8) of the Social Security Act (42 

5 U.S.C. 1395w–3a(b)(8)) is amended— 

6 (1) by redesignating subparagraphs (A) and 

7 (B) as clauses (i) and (ii), respectively, and moving 

8 the margin of each such redesignated clause 2 ems 

9 to the right; 

10 (2) by striking ‘‘PRODUCT.—The amount’’ and 

11 inserting the following: ‘‘PRODUCT.— 

12 ‘‘(A) IN GENERAL.—Subject to subpara13 graph (B), the amount’’; and 

14 (3) by adding at the end the following new sub15 paragraph: 

16 ‘‘(B) TEMPORARY PAYMENT INCREASE.— 

17 ‘‘(i) IN GENERAL.—In the case of a 

18 qualifying biosimilar biological product 

19 that is furnished during the applicable 5- 

20 year period for such product, the amount 

21 specified in this paragraph for such prod22 uct with respect to such period is the sum 

23 determined under subparagraph (A), ex24 cept that clause (ii) of such subparagraph 

25 shall be applied by substituting ‘8 percent’ 

26 for ‘6 percent’. 


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1 ‘‘(ii) APPLICABLE 5-YEAR PERIOD.— 

2 For purposes of clause (i), the applicable 

3 5-year period for a biosimilar biological 

4 product is— 

5 ‘‘(I) in the case of such a product 

6 for which payment was made under 

7 this paragraph as of December 31, 

8 2019, the 5-year period beginning on 

9 January 1, 2020; and 

10 ‘‘(II) in the case of such a prod11 uct for which payment is first made 

12 under this paragraph during a cal13 endar quarter during the period be14 ginning January 1, 2020, and ending 

15 December 31, 2024, the 5-year period 

16 beginning on the first day of such cal17 endar quarter during which such pay18 ment is first made. 

19 ‘‘(iii) QUALIFYING BIOSIMILAR BIO20 LOGICAL PRODUCT DEFINED.—For pur21 poses of this subparagraph, the term 

22 ‘qualifying biosimilar biological product’ 

23 means a biosimilar biological product de24 scribed in paragraph (1)(C) with respect to 

25 which— 


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1 ‘‘(I) in the case of a product de2 scribed in clause (ii)(I), the average 

3 sales price is not more than the aver4 age sales price for the reference bio5 logical product; and 

6 ‘‘(II) in the case of a product de7 scribed in clause (ii)(II), the wholesale 

8 acquisition cost is not more than the 

9 wholesale acquisition cost for the ref10 erence biological product’’. 

Æ 


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