What This Bill Does
This bill requires the Secretary of Health and Human Services to create and run a 3-year test program within Medicare Part B (a part of Medicare that covers certain medical services). The test program will pay extra money to doctors and providers who give patients biosimilar biological products (cheaper versions of expensive biological drugs) to see if this increases patient access to these drugs.
Who It Affects
- Doctors and medical providers who participate in the program
- Medicare beneficiaries (people enrolled in Medicare Part B)
- The Secretary of Health and Human Services
Key Provisions
- The Secretary must establish the demonstration project no later than 1 year after the bill becomes law and run it for 3 years nationwide under Medicare Part B (Sec. 2(a))
- Participation is voluntary and providers can quit at any time; the Secretary can also remove providers from the program at any time (Sec. 2(b)(1))
- Any provider who applies gets selected automatically to participate in the program (Sec. 2(b)(2))
- Participating providers receive an additional payment on top of normal Medicare payment based on the cost difference between biosimilar drugs and the original expensive drugs they replace (Sec. 2(d)(1))
- The additional payment cannot increase what Medicare patients have to pay out of pocket (Sec. 2(d)(2))
- The Secretary must report to Congress 3 years after the bill passes with analysis of whether to expand or extend the program (Sec. 2(f)(1))
What Changes
If this becomes law, Medicare will begin offering extra payments to healthcare providers who use cheaper biosimilar biological products instead of original expensive biological products for Medicare patients. This extra payment aims to reward providers for switching patients to these lower-cost alternatives.
Important Definitions
- Biosimilar biological product: A drug approved as a cheaper copy of an expensive biological drug, using some information from the original drug's approval
- Eligible provider: A doctor or medical supplier approved to receive Medicare payment for providing biosimilar biological products
- Medicare beneficiary: A person enrolled in Medicare Part B
- Participating provider: An eligible provider selected for and currently in the program
- Reference biological product: The original expensive biological drug that the biosimilar copies
Effective Date
The demonstration project must begin no later than 1 year after the bill becomes law (Sec. 2(a))
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-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘Increasing Access to
4
Biosimilars Act of 2023’’.
5
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•HR 1352 IH
SEC. 2. DEMONSTRATION PROJECT TO INCREASE ACCESS
1
TO
BIOSIMILAR
BIOLOGICAL
PRODUCTS
2
UNDER THE MEDICARE PROGRAM.
3
(a) ESTABLISHMENT.—Beginning not later than 1
4
year after the date of the enactment of this Act, the Sec-
5
retary of Health and Human Services shall establish and
6
implement a 3-year nationwide demonstration project
7
under part B of title XVIII of the Social Security Act to
8
evaluate the benefits of providing a shared savings pay-
9
ment for biosimilar biological products furnished under
10
such part.
11
(b) PARTICIPATION.—
12
(1) IN
GENERAL.—Participation under the
13
demonstration project shall be voluntary, and a par-
14
ticipating provider may terminate participation at
15
any time and the Secretary may terminate the par-
16
ticipation of such a provider at any time.
17
(2) APPLICATION AND SELECTION.—To partici-
18
pate under the demonstration project, an eligible
19
provider shall submit to the Secretary an application
20
in such form and manner and containing such infor-
21
mation as specified by the Secretary. Each eligible
22
provider who submits such an application shall be
23
selected by the Secretary for participation under the
24
demonstration project.
25
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•HR 1352 IH
(3) CLARIFICATION.—Participation under the
1
demonstration project shall not preclude eligible pro-
2
viders from also participating in any model author-
3
ized under section 1115A of the Social Security Act
4
(42 U.S.C. 1315a), including the Oncology Care
5
Model and Oncology Care First Model, or impact eli-
6
gible providers metrics or expenditures within other
7
models authorized under such section.
8
(c) COVERAGE.—Except as otherwise provided in this
9
section, payment may be made under the demonstration
10
project for a biosimlar biological product only if such prod-
11
uct is covered under part B of title XVIII of the Social
12
Security Act and such payment shall be made in the same
13
manner as payment is provided for such a product under
14
such part.
15
(d) ADDITIONAL PAYMENT.—
16
(1) IN
GENERAL.—Under the demonstration
17
project, subject to paragraph (3), in addition to the
18
payment that would otherwise be made under part
19
B of title XVIII of the Social Security Act for a bio-
20
similar biological product furnished or dispensed by
21
a participating provider to a Medicare beneficiary,
22
there shall be made an additional payment, in an
23
amount determined by the Secretary, that is based
24
on the difference, if any, (or portion of such dif-
25
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•HR 1352 IH
ference) between the costs to the provider in fur-
1
nishing the biosimilar biological product and the
2
costs to the provider if the provider had furnished
3
the reference biological product.
4
(2) NO
INCREASE
TO
MEDICARE
COINSUR-
5
ANCE.—The additional payment described under
6
paragraph (1) shall not increase a Medicare bene-
7
ficiary’s cost-sharing liability, as described in section
8
1833 of the Social Security Act (42 U.S.C. 1395l).
9
(3) EXCEPTION.—An eligible provider may only
10
receive the additional payment described in para-
11
graph (1), with respect to a biosimilar biological
12
product, if the payment amount under section
13
1847A of the Social Security Act (42 U.S.C.
14
1395w–3a) for such product is less than the pay-
15
ment amount under part B of title XVIII of such
16
Act for the reference biological product.
17
(e) WAIVER AUTHORITY.—The Secretary may waive
18
such requirements of title XVIII of the Social Security Act
19
as may be necessary to carry out the demonstration
20
project, except the Secretary may not increase the cost-
21
sharing that would otherwise, without application of this
22
section, be applied to an individual under section 1833 of
23
the Social Security Act (42 U.S.C. 1395l).
24
(f) REPORTS.—
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•HR 1352 IH
(1) INTERIM EVALUATION AND REPORT.—Not
1
later than 3 years after the date of enactment of
2
this Act, the Secretary shall submit to Congress a
3
report that contains an analysis of the appropriate-
4
ness of expanding or extending the demonstration
5
project and, to the extent such analysis determines
6
such an expansion or extension appropriate, rec-
7
ommendations for such expansion or extension, re-
8
spectively.
9
(2) FINAL
EVALUATION
AND
REPORT.—Not
10
later than one year after the date of completion of
11
the demonstration project, the Secretary shall sub-
12
mit to Congress a report that contains a final anal-
13
ysis of the project and recommendations described in
14
paragraph (1).
15
(g) DEFINITIONS.—In this section:
16
(1) DEMONSTRATION
PROJECT.—The term
17
‘‘demonstration project’’ means the demonstration
18
project conducted under this Act.
19
(2) BIOSIMILAR
BIOLOGICAL
PRODUCT.—The
20
term ‘‘biosimilar biological product’’ means a biologi-
21
cal product approved under an abbreviated applica-
22
tion for a license of a biological product that relies
23
in part on data or information in an application for
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•HR 1352 IH
another biological product licensed under section 351
1
of the Public Health Service Act (42 U.S.C. 262).
2
(3) ELIGIBLE PROVIDER.—The term ‘‘eligible
3
provider’’ means a provider of services or supplier
4
that is eligible to receive payment under part B of
5
title XVIII of the Social Security Act for furnishing
6
or dispensing biosimilar biological products.
7
(4)
MEDICARE
BENEFICIARY.—The
term
8
‘‘Medicare beneficiary’’ means an individual who is
9
enrolled for benefits under part B of title XVIII of
10
the Social Security Act.
11
(5)
PARTICIPATING
PROVIDER.—The
term
12
‘‘participating provider’’ means an eligible provider
13
that has been selected for participation under the
14
project under subsection (b)(2) and with respect to
15
whom such participation has not been terminated.
16
(6) REFERENCE
BIOLOGICAL
PRODUCT.—The
17
term ‘‘reference biological product’’ means the bio-
18
logical product licensed under section 351 of the
19
Public Health Service Act (42 U.S.C. 262) that is
20
referred to in the application described in paragraph
21
(2) of the biosimilar biological product.
22
Æ
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