Increasing Access to Biosimilars Act of 2021

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 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 (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 (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 (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 (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) (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 (e) Waiver authority The Secretary may waive such requirements of titles XI and XVIII of the Social Security Act ( 42 U.S.C. 1301 (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 (2) Demonstration project The term demonstration project (3) Eligible provider The term eligible provider 42 U.S.C. 1395j (4) Medicare beneficiary The term Medicare beneficiary (5) Participating provider The term participating provider (6) Reference biological product The term reference biological product (7) Secretary The term Secretary

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.