Increasing Access to Biosimilars Act of 2020

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.

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.

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.

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.

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.

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.

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.

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).

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.

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).