Page:United States Statutes at Large Volume 124.djvu/466

124 STAT. 440 PUBLIC LAW 111–148—MAR. 23, 2010 ‘‘(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 speci- fied 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 para- graph (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 ‘bio- similar 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 informa- tion in an application for another biological product licensed under section 351 of the Public Health Service Act. ‘‘(I) REFERENCE BIOLOGICAL PRODUCT.—The term ‘ref- erence 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) EFFECTIVE DATE.—The amendments made by subsection (a) shall apply to payments for biosimilar biological products begin- ning with the first day of the second calendar quarter after enact- ment of legislation providing for a biosimilar pathway (as deter- mined by the Secretary). SEC. 3140. MEDICARE HOSPICE CONCURRENT CARE DEMONSTRATION PROGRAM. (a) ESTABLISHMENT.— (1) IN GENERAL.—The Secretary of Health and Human Services (in this section referred to as the ‘‘Secretary’’) shall establish a Medicare Hospice Concurrent Care demonstration program at participating hospice programs under which Medi- care beneficiaries are furnished, during the same period, hos- pice care and any other items or services covered under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) from funds otherwise paid under such title to such hospice programs. (2) DURATION.—The demonstration program under this sec- tion shall be conducted for a 3-year period. (3) SITES.—The Secretary shall select not more than 15 hospice programs at which the demonstration program under this section shall be conducted. Such hospice programs shall be located in urban and rural areas. (b) INDEPENDENT EVALUATION AND REPORTS.— (1) INDEPENDENT EVALUATION.—The Secretary shall pro- vide for the conduct of an independent evaluation of the dem- onstration program under this section. Such independent evaluation shall determine whether the demonstration program 42 USC 1395d note. Applicability. 42 USC 1395w–3a note.