[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1352 Introduced in House (IH)]

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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.
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