I 
117TH CONGRESS 
1ST SESSION H. R. 2855 
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 
APRIL 26, 2021 
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 provi-
sions 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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Star Rating for 
Biosimilars Act’’. 
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SEC. 2. ADDITION OF NEW MEASURES BASED ON ACCESS 
TO BIOSIMILAR BIOLOGICAL PRODUCTS TO 
THE 5-STAR RATING SYSTEM UNDER MEDI-
CARE ADVANTAGE. 
(a) IN GENERAL.—Section 1853(o)(4) of the Social 
Security Act (42 U.S.C. 1395w–23(o)(4)) is amended by 
adding at the end the following new subparagraph: 
‘‘(E) ADDITION OF NEW MEASURES BASED 
ON ACCESS TO BIOSIMILAR BIOLOGICAL PROD-
UCTS.— 
‘‘(i) IN
GENERAL.—For 2022 and 
subsequent years, the Secretary shall add a 
new set of measures to the 5-star rating 
system based on access to biosimilar bio-
logical products covered under part B and, 
in the case of MA–PD plans, such prod-
ucts that are covered part D drugs. Such 
measures shall assess the impact a plan’s 
benefit structure may have on enrollees’ 
utilization of or ability to access biosimilar 
biological products, including in compari-
son to the reference biological product, and 
shall include measures, as applicable, with 
respect to the following: 
‘‘(I) 
COVERAGE.—Assessing 
whether a biosimilar biological prod-
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uct is on the plan formulary in lieu of 
or in addition to the reference biologi-
cal product. 
‘‘(II) 
PREFERENCING.—Assess-
ing tier placement or cost sharing for 
a biosimilar biological product relative 
to the reference biological product. 
‘‘(III) 
UTILIZATION
MANAGE-
MENT TOOLS.—Assessing whether and 
how utilization management tools are 
used with respect to a biosimilar bio-
logical product relative to the ref-
erence biological product. 
‘‘(IV) 
UTILIZATION.—Assessing 
the percentage of enrollees prescribed 
the biosimilar biological product when 
the reference biological product is also 
available. 
‘‘(ii) DEFINITIONS.—In this subpara-
graph, the terms ‘biosimilar biological 
product’ and ‘reference biological product’ 
have the meaning given those terms in sec-
tion 1847A(c)(6). 
‘‘(iii) PROTECTING
PATIENT
INTER-
ESTS.—In developing such measures, the 
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Secretary shall ensure that each measure 
developed to address coverage, preferenc-
ing, or utilization management is con-
structed such that patients retain equal ac-
cess to appropriate therapeutic options 
without undue administrative burden.’’. 
(b) CLARIFICATION REGARDING APPLICATION
TO 
PRESCRIPTION DRUG PLANS.—To the extent the Sec-
retary of Health and Human Services applies the 5-star 
rating system under section 1853(o)(4) of the Social Secu-
rity Act (42 U.S.C. 1395w–23(o)(4)), or a similar system, 
to prescription drug plans under part D of title XVIII of 
such Act, the provisions of subparagraph (E) of such sec-
tion, as added by subsection (a) of this section, shall apply 
under the system with respect to such plans in the same 
manner as such provisions apply to the 5-star rating sys-
tem under such section 1853(o)(4). 
Æ 
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