I 
116TH CONGRESS 
1ST SESSION H. R. 4597 
To amend title XVIII of the Social Security Act to eliminate cost sharing 
for biosimilar biological products furnished under part B of the Medicare 
program. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 1, 2019 
Mr. PETERS (for himself, Mr. BRINDISI, and Mr. KING of New York) intro-
duced 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 eliminate 
cost sharing for biosimilar biological products furnished 
under part B of the Medicare program. 
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 ‘‘Acting to Cancel 
Copays and Ensure Substantial Savings for Biosimilars 
Act of 2019’’ or the ‘‘ACCESS for Biosimilars Act of 
2019’’. 
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SEC. 2. ELIMINATING COST SHARING FOR BIOSIMILAR BIO-
LOGICAL 
PRODUCTS 
FURNISHED 
UNDER 
PART B OF THE MEDICARE PROGRAM. 
Section 1833 of the Social Security Act (42 U.S.C. 
1395l) is amended— 
(1) in subsection (a)(1)(S), by inserting ‘‘(or, in 
the case of such a biological that is a specified bio-
similar biological product (as defined in subsection 
(cc)) furnished during a year (beginning with 2020) 
to an individual who is a cost-sharing reduction eli-
gible individual (as defined in such subsection) with 
respect to such year, 100 percent)’’ after ‘‘80 per-
cent’’; and 
(2) by adding at the end the following new sub-
section: 
‘‘(cc) SPECIFIED BIOSIMILAR BIOLOGICAL PRODUCT 
REDUCED COST-SHARING PROVISIONS.— 
‘‘(1) DEFINITIONS.— 
‘‘(A) COST-SHARING REDUCTION ELIGIBLE 
INDIVIDUAL DEFINED.—For purposes of sub-
section (a)(1)(S) and with respect to a year, the 
term ‘cost-sharing reduction eligible individual’ 
means an individual who, as of January 1 of 
such year— 
‘‘(i) is enrolled under this part; and 
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into account the application of any deduct-
ible under such coverage. 
‘‘(iii) CONDITION
FOR
PART
C
COV-
ERAGE.—For 
purposes 
of 
clause 
(i)(II)(bb), the condition described in this 
clause, with respect to an individual en-
rolled in an MA or MA–PD plan during a 
year, is that such plan provides for no cost 
sharing for such individual with respect to 
a specified biological biosimilar product (as 
defined in subparagraph (C)) furnished 
under such plan during such year. 
‘‘(C) SPECIFIED
BIOSIMILAR
BIOLOGICAL 
PRODUCT.—For 
purposes 
of 
subsection 
(a)(1)(S), the term ‘specified biosimilar biologi-
cal product’ means a biosimilar biological prod-
uct (as defined in subsection (c)(6) of section 
1847A) for which the payment amount deter-
mined under subsection (b)(8) of such section 
for such product is less than the payment 
amount determined under subsection (b)(4) of 
such section for the reference biological product 
(as defined in subsection (c)(6) of such section). 
‘‘(2) DETERMINATIONS.—The Secretary shall 
establish a process— 
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‘‘(A) for determining whether an individual 
is a cost-sharing reduction eligible individual for 
a year; and 
‘‘(B) for notifying MA organizations of 
such a determination made with respect to an 
individual enrolled under an MA plan or MA– 
PD plan offered by such organization during 
such year.’’. 
Æ 
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