Increasing Access to Biosimilars Act of 2021

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. 1. Short title This Act may be cited as the Increasing Access to Biosimilars Act of 2021 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 (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 (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 (2) Biosimilar biological product The term biosimilar biological product 42 U.S.C. 262 (3) Eligible provider The term eligible provider (4) Medicare beneficiary The term Medicare beneficiary (5) Participating provider The term participating provider (6) Reference biological product The term reference biological product 42 U.S.C. 262

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.