Increasing Access to Biosimilars Act of 2021
Bill: S.1427 | Sponsor: Sen. Cornyn, John (R-TX)
Policy area: Health

Summary:
Increasing Access to Biosimilars Act of 2021
This bill requires the Centers for Medicare & Medicaid Services to establish a demonstration project to evaluate the benefits of providing additional payments to providers of biosimilars under Medicare. Specifically, under the demonstration project, participating providers receive an additional payment based on the difference between the costs to the provider of furnishing the biosimilar and the cost if the provider had furnished the underlying reference biological product instead.

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 2021''.

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 enactment of this Act, the Secretary shall establish and implement a 
5-year nationwide demonstration project under part B of title XVIII of 
the Social Security Act (42 U.S.C. 1395j et seq.) to evaluate the 
benefits of providing a shared savings payment for biosimilar 
biological products furnished under such part. At the discretion of the 
Secretary, the demonstration project may be extended for an additional 
2 years past the initial 5-year period.
    (b) Participation.--
            (1) In general.--Participation in 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 for failure to 
        comply with the requirements of the demonstration project.
            (2) Application and selection.--To participate in 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) Participation in innovation center models.--
        Participation in the demonstration project shall not preclude 
        an eligible provider 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 the 
        Oncology Care First Model, or impact metrics or expenditures 
        with respect to an eligible provider under any model authorized 
        under such section.
    (c) Coverage.--Except as otherwise provided in this section, 
payment may be made under the demonstration project for a biosimilar 
biological product only if such product is covered under part B of 
title XVIII of the Social Security Act (42 U.S.C. 1395j et seq.) 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.--Subject to paragraphs (2) and (3), in 
        addition to the amount of payment that would otherwise be made 
        under part B of title XVIII of the Social Security Act (42 
        U.S.C. 1395j et seq.) for a biosimilar biological product 
        furnished or dispensed by a participating provider to a 
        Medicare beneficiary under the demonstration project, there 
        shall be made an additional payment, in an amount determined by 
        the Secretary, that reflects a portion of any difference 
        between such amount of payment under such part, as compared to 
        the amount of payment that would have been made under such part 
        if the reference biological product had been furnished or 
        dispensed to the beneficiary.
            (2) Medicare beneficiary coinsurance liability.--The 
        additional payment provided under paragraph (1) shall not be 
        taken into account when determining the amount of coinsurance 
        under section 1833(a)(1)(S) of the Social Security Act (42 
        U.S.C. 1395l(a)(1)(S)) for a biosimilar biological product 
        furnished or dispensed to a Medicare beneficiary by a 
        participating provider under the demonstration project. The 
        Secretary may use a portion of the difference described in such 
        paragraph to waive or reduce the amount of coinsurance 
        otherwise applicable under such section for such a biosimilar 
        biological.
            (3) Exception to additional payment.--A participating 
        provider may only receive the additional payment described in 
        paragraph (1) with respect to a biosimilar biological product 
        furnished or dispensed by the participating provider to a 
        Medicare beneficiary under the demonstration project, if the 
        amount of payment determined under section 1847A of the Social 
        Security Act (42 U.S.C. 1395w-3a) for the biosimilar biologic 
        product is less than the amount of payment determined under 
        such section for the reference biological product.
    (e) Waiver Authority.--The Secretary may waive such requirements of 
titles XI and XVIII of the Social Security Act (42 U.S.C. 1301 et seq., 
1395 et seq.) as may be necessary to carry out the demonstration 
project.
    (f) Data Collection.--
            (1) In general.--The Secretary shall collect data on the 
        sex, race, ethnicity, and geographic and socioeconomic 
        characteristics of Medicare beneficiaries to whom a biosimilar 
        biological product is furnished or dispensed by a participating 
        provider under the demonstration project.
            (2) Consideration.--The Secretary shall take into account 
        data collected under paragraph (1) in evaluating the 
        demonstration project in each of the reports submitted under 
        subsection (g).
    (g) 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) Evaluation and report.--Not later than 1 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).
    (h) Definitions.--In this section:
            (1) Biosimilar biological product.--The term ``biosimilar 
        biological product'' has the meaning given that term in section 
        1847A(c)(6)(H) of the Social Security Act (42 U.S.C. 1395w-
        3a(c)(6)(H)).
            (2) Demonstration project.--The term ``demonstration 
        project'' means the demonstration project conducted under this 
        section.
            (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 (42 U.S.C. 1395j et seq.) for furnishing or 
        dispensing a biosimilar biological product.
            (4) Medicare beneficiary.--The term ``Medicare 
        beneficiary'' means an individual who is enrolled for benefits 
        under such part.
            (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'' has the meaning given that term in section 
        1847A(c)(6)(I) of the Social Security Act (42 U.S.C. 1395w-
        3a(c)(6)(I)).
            (7) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
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