I 
117TH CONGRESS 
1ST SESSION H. R. 2869 
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 
APRIL 28, 2021 
Mr. CA´RDENAS (for himself and Ms. CRAIG) 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 subse-
quently 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 2021’’. 
VerDate Sep 11 2014 
19:25 Jun 18, 2021
Jkt 019200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H2869.IH
H2869
pbinns on DSKJLVW7X2PROD with BILLS
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. 
VerDate Sep 11 2014 
19:25 Jun 18, 2021
Jkt 019200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H2869.IH
H2869
pbinns on DSKJLVW7X2PROD with BILLS
(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-
VerDate Sep 11 2014 
19:25 Jun 18, 2021
Jkt 019200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H2869.IH
H2869
pbinns on DSKJLVW7X2PROD with BILLS
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.— 
VerDate Sep 11 2014 
19:25 Jun 18, 2021
Jkt 019200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H2869.IH
H2869
pbinns on DSKJLVW7X2PROD with BILLS
(1) INTERIM EVALUATION AND REPORT.—Not 
later than 3 years after the date of enactment of 
this Act, the Secretary shall submit to Congress a 
report that contains an analysis of the appropriate-
ness of expanding or extending the demonstration 
project and, to the extent such analysis determines 
such an expansion or extension appropriate, rec-
ommendations for such expansion or extension, re-
spectively. 
(2) FINAL
EVALUATION
AND
REPORT.—Not 
later than one year after the date of completion of 
the demonstration project, the Secretary shall sub-
mit to Congress a report that contains a final anal-
ysis of the project and recommendations described in 
paragraph (1). 
(g) DEFINITIONS.—In this section: 
(1) DEMONSTRATION
PROJECT.—The term 
‘‘demonstration project’’ means the demonstration 
project conducted under this Act. 
(2) BIOSIMILAR
BIOLOGICAL
PRODUCT.—The 
term ‘‘biosimilar biological product’’ means a biologi-
cal product approved under an abbreviated applica-
tion for a license of a biological product that relies 
in part on data or information in an application for 
VerDate Sep 11 2014 
19:25 Jun 18, 2021
Jkt 019200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H2869.IH
H2869
pbinns on DSKJLVW7X2PROD with BILLS
another biological product licensed under section 351 
of the Public Health Service Act (42 U.S.C. 262). 
(3) ELIGIBLE PROVIDER.—The term ‘‘eligible 
provider’’ means a provider of services or supplier 
that is eligible to receive payment under part B of 
title XVIII of the Social Security Act for furnishing 
or dispensing biosimilar biological products. 
(4) 
MEDICARE
BENEFICIARY.—The 
term 
‘‘Medicare beneficiary’’ means an individual who is 
enrolled for benefits under part B of title XVIII of 
the Social Security Act. 
(5) 
PARTICIPATING
PROVIDER.—The 
term 
‘‘participating provider’’ means an eligible provider 
that has been selected for participation under the 
project under subsection (b)(2) and with respect to 
whom such participation has not been terminated. 
(6) REFERENCE
BIOLOGICAL
PRODUCT.—The 
term ‘‘reference biological product’’ means the bio-
logical product licensed under section 351 of the 
Public Health Service Act (42 U.S.C. 262) that is 
referred to in the application described in paragraph 
(2) of the biosimilar biological product. 
Æ 
VerDate Sep 11 2014 
19:25 Jun 18, 2021
Jkt 019200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6301
E:\BILLS\H2869.IH
H2869
pbinns on DSKJLVW7X2PROD with BILLS