[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1352 Introduced in House (IH)]
<DOC>
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
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 require the Secretary of Health and Human Services to establish a
demonstration project to increase access to biosimilar biological
products under the Medicare program.
Be it enacted by the Senate and House of Representatives 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''.
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 Secretary 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
payment for biosimilar biological products furnished under such part.
(b) Participation.--
(1) In general.--Participation under the demonstration
project shall be voluntary, and a participating provider may
terminate participation at any time and the Secretary may
terminate the participation of such a provider at any time.
(2) Application and selection.--To participate under the
demonstration project, an eligible provider shall submit to the
Secretary an application in such form and manner and containing
such information 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.
(3) Clarification.--Participation under the demonstration
project shall not preclude eligible providers from also
participating in any model authorized 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
eligible 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 product 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 biosimilar 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 difference) between the
costs to the provider in furnishing the biosimilar biological
product and the costs to the provider if the provider had
furnished the reference biological product.
(2) No increase to medicare coinsurance.--The additional
payment described under paragraph (1) shall not increase a
Medicare beneficiary'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 paragraph (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 payment 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.--
(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
appropriateness of expanding or extending the demonstration
project and, to the extent such analysis determines such an
expansion or extension appropriate, recommendations for such
expansion or extension, respectively.
(2) Final evaluation and report.--Not later than one year
after the date of completion of the demonstration project, the
Secretary shall submit to Congress a report that contains a
final analysis 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 biological product approved under
an abbreviated application for a license of a biological
product that relies in part on data or information in an
application for 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 biological 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.
<all>