PAYMENT FOR BIOSIMILAR BIOLOGICAL PRODUCTS.

SEC. 3139. PAYMENT FOR BIOSIMILAR BIOLOGICAL PRODUCTS. (a) In General.—Section 1847A of the Social Security Act (42 U.S.C. 1395w–3a) is amended— (1) in subsection (b)— (A) in paragraph (1)— (i) in subparagraph (A), by striking “or” at the end; (ii) in subparagraph (B), by striking the period at the end and inserting “; or”; and (iii) by adding at the end the following new subparagraph: “(C) in the case of a biosimilar biological product (as defined in subsection (c)(6)(H)), the amount determined under paragraph (8).” ; and (B) by adding at the end the following new paragraph: “(8) Biosimilar biological product.—The amount specified in this paragraph for a biosimilar biological product described in paragraph (1)(C) is the sum of— “(A) the average sales price as determined using the methodology described under paragraph (6) applied to a biosimilar biological product for all National Drug Codes assigned to such product in the same manner as such paragraph is applied to drugs described in such paragraph; and “(B) 6 percent of the amount determined under paragraph (4) for the reference biological product (as defined in subsection (c)(6)(I)).” ; and (2) in subsection (c)(6), by adding at the end the following new subparagraph: “(H) 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. “(I) Reference Biological product.—The term ‘reference biological product’ means the biological product licensed under such section 351 that is referred to in the application described in subparagraph (H) of the biosimilar biological product.” . (b) [42 U.S.C. 1395w–3a note] Effective Date.—The amendments made by subsection (a) shall apply to payments for biosimilar biological products beginning with the first day of the second calendar quarter after enactment of legislation providing for a biosimilar pathway (as determined by the Secretary).