I 

116TH CONGRESS 

1ST SESSION H. R. 4629 

To amend title XVIII of the Social Security Act to require the Secretary 

of Health and Human Services to add a new set of measures to the 

5-star rating system under the Medicare Advantage program in order 

to encourage increased access to biosimilar biological products. 

IN THE HOUSE OF REPRESENTATIVES 

OCTOBER 8, 2019 

Mr. TONKO (for himself and Mr. GIBBS) 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 require 

the Secretary of Health and Human Services to add 

a new set of measures to the 5-star rating system under 

the Medicare Advantage program in order to encourage 

increased access to biosimilar biological 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 ‘‘Star Rating for 

5 Biosimilars Act’’. 


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1 SEC. 2. ADDITION OF NEW MEASURES BASED ON ACCESS 

2 TO BIOSIMILAR BIOLOGICAL PRODUCTS TO 

3 THE 5-STAR RATING SYSTEM UNDER MEDI4 CARE ADVANTAGE. 

5 (a) IN GENERAL.—Section 1853(o)(4) of the Social 

6 Security Act (42 U.S.C. 1395w–23(o)(4)) is amended by 

7 adding at the end the following new subparagraph: 

8 ‘‘(E) ADDITION OF NEW MEASURES BASED

9 ON ACCESS TO BIOSIMILAR BIOLOGICAL PROD10 UCTS.— 

11 ‘‘(i) IN GENERAL.—For 2021 and 

12 subsequent years, the Secretary shall add a 

13 new set of measures to the 5-star rating 

14 system based on access to biosimilar bio15 logical products covered under part B and, 

16 in the case of MA–PD plans, such prod17 ucts that are covered part D drugs. Such 

18 measures shall assess the impact a plan’s 

19 benefit structure may have on enrollees’ 

20 utilization of or ability to access biosimilar 

21 biological products, including in compari22 son to the reference biological product, and 

23 shall include measures, as applicable, with 

24 respect to the following: 

25 ‘‘(I) COVERAGE.—Assessing 

26 whether a biosimilar biological prodVerDate Sep 11 2014 23:28 Oct 08, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4629.IH H4629

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1 uct is on the plan formulary in lieu of 

2 or in addition to the reference biologi3 cal product. 

4 ‘‘(II) PREFERENCING.—Assess5 ing tier placement or cost sharing for 

6 a biosimilar biological product relative 

7 to the reference biological product. 

8 ‘‘(III) UTILIZATION MANAGE9 MENT TOOLS.—Assessing whether and 

10 how utilization management tools are 

11 used with respect to a biosimilar bio12 logical product relative to the ref13 erence biological product. 

14 ‘‘(IV) UTILIZATION.—Assessing 

15 the percentage of enrollees prescribed 

16 the biosimilar biological product when 

17 the reference biological product is also 

18 available. 

19 ‘‘(ii) DEFINITIONS.—In this subpara20 graph, the terms ‘biosimilar biological 

21 product’ and ‘reference biological product’ 

22 have the meaning given those terms in sec23 tion 1847A(c)(6). 

24 ‘‘(iii) PROTECTING PATIENT INTER25 ESTS.—In developing such measures, the 


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1 Secretary shall ensure that each measure 

2 developed to address coverage, preferenc3 ing, or utilization management is con4 structed such that patients retain equal ac5 cess to appropriate therapeutic options 

6 without undue administrative burden.’’. 

7 (b) CLARIFICATION REGARDING APPLICATION TO

8 PRESCRIPTION DRUG PLANS.—To the extent the Sec9 retary of Health and Human Services applies the 5-star 

10 rating system under section 1853(o)(4) of the Social Secu11 rity Act (42 U.S.C. 1395w–23(o)(4)), or a similar system, 

12 to prescription drug plans under part D of title XVIII of 

13 such Act, the provisions of subparagraph (E) of such sec14 tion, as added by subsection (a) of this section, shall apply 

15 under the system with respect to such plans in the same 

16 manner as such provisions apply to the 5-star rating sys17 tem under such section 1853(o)(4). 

Æ 


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