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II
116TH CONGRESS
2D SESSION
S. 3466
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 during the first 5 years such products are marketed.
IN THE SENATE OF THE UNITED STATES
MARCH 12, 2020
Ms. MCSALLY (for herself and Mr. JONES) introduced the following bill; which
was read twice and referred to the Committee on Finance
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 during the first
5 years such products are marketed.
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘Acting to Cancel
4
Copays and Ensure Substantial Savings for Biosimilars
5
Act of 2020’’ or the ‘‘ACCESS for Biosimilars Act of
6
2020’’.
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•S 3466 IS
SEC. 2. ELIMINATING COST SHARING FOR BIOSIMILAR BIO-
1
LOGICAL
PRODUCTS
FURNISHED
UNDER
2
PART B OF THE MEDICARE PROGRAM.
3
Section 1833 of the Social Security Act (42 U.S.C.
4
1395l) is amended—
5
(1) in subsection (a)(1)(S), by inserting ‘‘(or, in
6
the case of such a biological that is a specified bio-
7
similar biological product (as defined in subsection
8
(cc)) furnished during a year (beginning with 2021)
9
to an individual who is a cost-sharing reduction eli-
10
gible individual (as defined in such subsection) with
11
respect to such year, 100 percent)’’ after ‘‘80 per-
12
cent’’; and
13
(2) by adding at the end the following new sub-
14
section:
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‘‘(cc) SPECIFIED BIOSIMILAR BIOLOGICAL PRODUCT
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REDUCED COST-SHARING PROVISIONS.—
17
‘‘(1) DEFINITIONS.—
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‘‘(A) COST-SHARING REDUCTION ELIGIBLE
19
INDIVIDUAL DEFINED.—For purposes of sub-
20
section (a)(1)(S) and with respect to a year, the
21
term ‘cost-sharing reduction eligible individual’
22
means an individual who, as of January 1 of
23
such year—
24
‘‘(i) is enrolled under this part; and
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‘‘(ii) does not have qualifying coverage
1
(as defined in subparagraph (B)).
2
‘‘(B) QUALIFYING COVERAGE.—
3
‘‘(i) IN
GENERAL.—For purposes of
4
subparagraph (A), the term ‘qualifying
5
coverage’ means, with respect to an indi-
6
vidual, coverage—
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‘‘(I) under—
8
‘‘(aa) a group health plan or
9
health insurance coverage (as
10
such terms are defined in section
11
2791 of the Public Health Serv-
12
ice Act);
13
‘‘(bb) a Federal health care
14
program (as defined in section
15
1128B(f)), other than the pro-
16
gram established under this title;
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‘‘(cc) the health insurance
18
program under chapter 89 of
19
title 5, United States Code;
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‘‘(dd) a medicare supple-
21
mental policy under section 1882;
22
or
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‘‘(ee) an MA or MA–PD
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plan; and
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‘‘(II) that meets—
1
‘‘(aa) in the case of coverage
2
described in any of items (aa)
3
through (dd) of subclause (I), the
4
condition described in clause (ii);
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and
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‘‘(bb) in the case of coverage
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described in item (ee) of sub-
8
clause (I), the condition described
9
in clause (iii).
10
‘‘(ii)
CONDITION
FOR
COVERAGE
11
OTHER
THAN
PART
C
COVERAGE.—For
12
purposes of clause (i)(II)(aa), the condition
13
described in this clause, with respect to an
14
individual enrolled in coverage described in
15
any of items (aa) through (dd) of clause
16
(i)(I) during a year, is that such coverage
17
provides for the payment of all cost shar-
18
ing owed by such individual under this
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part (or, if applicable, under an MA or
20
MA–PD plan) with respect to a specified
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biosimilar biological product (as defined in
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subparagraph (C)) furnished under this
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part (or, if applicable, under an MA or
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MA–PD plan) during such year, not taking
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into account the application of any deduct-
1
ible under such coverage.
2
‘‘(iii) CONDITION
FOR
PART
C
COV-
3
ERAGE.—For
purposes
of
clause
4
(i)(II)(bb), the condition described in this
5
clause, with respect to an individual en-
6
rolled in an MA or MA–PD plan during a
7
year, is that such plan provides for no cost
8
sharing for such individual with respect to
9
a specified biological biosimilar product (as
10
defined in subparagraph (C)) furnished
11
under such plan during such year.
12
‘‘(C) SPECIFIED
BIOSIMILAR
BIOLOGICAL
13
PRODUCT.—For
purposes
of
subsection
14
(a)(1)(S), the term ‘specified biosimilar biologi-
15
cal product’ means a biosimilar biological prod-
16
uct (as defined in subsection (c)(6) of section
17
1847A)—
18
‘‘(i) for which the payment amount
19
determined under subsection (b)(8) of such
20
section for such product is less than the
21
payment amount determined under sub-
22
section (b)(4) of such section for the ref-
23
erence biological product (as defined in
24
subsection (c)(6) of such section); and
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‘‘(ii) that is furnished during the 5-
1
year period beginning on the later of—
2
‘‘(I) January 1, 2021; or
3
‘‘(II) the date on which the bio-
4
similar biological product is first mar-
5
keted.
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‘‘(2) DETERMINATIONS.—The Secretary shall
7
establish a process—
8
‘‘(A) for determining whether an individual
9
is a cost-sharing reduction eligible individual for
10
a year; and
11
‘‘(B) for notifying MA organizations of
12
such a determination made with respect to an
13
individual enrolled under an MA plan or MA–
14
PD plan offered by such organization during
15
such year.’’.
16
Æ
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