I 
118TH CONGRESS 
1ST SESSION H. R. 1352 
To require the Secretary of Health and Human Services to establish a 
demonstration project to increase access to biosimilar biological products 
under the Medicare program. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 3, 2023 
Mr. HUDSON introduced the following bill; which was referred to the Com-
mittee 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 require the Secretary of Health and Human Services 
to establish a demonstration project to increase access 
to biosimilar biological products under the Medicare pro-
gram. 
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 ‘‘Increasing Access to 
Biosimilars Act of 2023’’. 
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SEC. 2. DEMONSTRATION PROJECT TO INCREASE ACCESS 
TO 
BIOSIMILAR 
BIOLOGICAL 
PRODUCTS 
UNDER THE MEDICARE PROGRAM. 
(a) ESTABLISHMENT.—Beginning not later than 1 
year after the date of the enactment of this Act, the Sec-
retary of Health and Human Services shall establish and 
implement a 3-year nationwide demonstration project 
under part B of title XVIII of the Social Security Act to 
evaluate the benefits of providing a shared savings pay-
ment for biosimilar biological products furnished under 
such part. 
(b) PARTICIPATION.— 
(1) IN
GENERAL.—Participation under the 
demonstration project shall be voluntary, and a par-
ticipating provider may terminate participation at 
any time and the Secretary may terminate the par-
ticipation of such a provider at any time. 
(2) APPLICATION AND SELECTION.—To partici-
pate under the demonstration project, an eligible 
provider shall submit to the Secretary an application 
in such form and manner and containing such infor-
mation as specified by the Secretary. Each eligible 
provider who submits such an application shall be 
selected by the Secretary for participation under the 
demonstration project. 
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(3) CLARIFICATION.—Participation under the 
demonstration project shall not preclude eligible pro-
viders from also participating in any model author-
ized under section 1115A of the Social Security Act 
(42 U.S.C. 1315a), including the Oncology Care 
Model and Oncology Care First Model, or impact eli-
gible providers metrics or expenditures within other 
models authorized under such section. 
(c) COVERAGE.—Except as otherwise provided in this 
section, payment may be made under the demonstration 
project for a biosimlar biological product only if such prod-
uct is covered under part B of title XVIII of the Social 
Security Act and such payment shall be made in the same 
manner as payment is provided for such a product under 
such part. 
(d) ADDITIONAL PAYMENT.— 
(1) IN
GENERAL.—Under the demonstration 
project, subject to paragraph (3), in addition to the 
payment that would otherwise be made under part 
B of title XVIII of the Social Security Act for a bio-
similar biological product furnished or dispensed by 
a participating provider to a Medicare beneficiary, 
there shall be made an additional payment, in an 
amount determined by the Secretary, that is based 
on the difference, if any, (or portion of such dif-
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ference) between the costs to the provider in fur-
nishing the biosimilar biological product and the 
costs to the provider if the provider had furnished 
the reference biological product. 
(2) NO
INCREASE
TO
MEDICARE
COINSUR-
ANCE.—The additional payment described under 
paragraph (1) shall not increase a Medicare bene-
ficiary’s cost-sharing liability, as described in section 
1833 of the Social Security Act (42 U.S.C. 1395l). 
(3) EXCEPTION.—An eligible provider may only 
receive the additional payment described in para-
graph (1), with respect to a biosimilar biological 
product, if the payment amount under section 
1847A of the Social Security Act (42 U.S.C. 
1395w–3a) for such product is less than the pay-
ment amount under part B of title XVIII of such 
Act for the reference biological product. 
(e) WAIVER AUTHORITY.—The Secretary may waive 
such requirements of title XVIII of the Social Security Act 
as may be necessary to carry out the demonstration 
project, except the Secretary may not increase the cost- 
sharing that would otherwise, without application of this 
section, be applied to an individual under section 1833 of 
the Social Security Act (42 U.S.C. 1395l). 
(f) REPORTS.— 
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