,,ii #aafth ,,congress #b;d ,session ,s4 #dacd ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #a1 #bjbj,mr4 ,cornyn 7for himself and ,mr4 ,bennet7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to establish a demonstration project to increase access to biosimilar biological products under the ,medicare program4 #a4 ,short title ,this ,act may be cited as the ,increasing ,access to ,biosimilars ,act of #bjbj4 #b4 ,demonstration project to increase access to biosimilar biological products under the ,medicare program 7a7 ,establishment ,beginning not later than #a year after the date of enactment of this ,act1 the ,secretary shall establish and implement a #e-year nationwide demonstration project under part ,b of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;j et seq47 to evaluate the benefits of providing a shared savings payment for biosimilar biological products furnished under such part4 ,at the discretion of the ,secretary1 the demonstration project may be extended for an additional #b years past the initial #e-year period4 7b7 ,participation 7#a7 ,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 project4 7#b7 ,application and selection ,to participate in the demonstration project1 an eligible provider shall submit to the ,secretary an application in such form and manner and containing such information as specified by the ,secretary4 ,each eligible provider who submits such an application shall be selected by the ,secretary for participation under the demonstration project4 7#c7 ,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 #aaae;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #acae;a71 including the ,oncology ,care ,model and the ,oncology ,care ,first ,model1 or impact metrics or expenditures with respect to an eligible provider under any model authorized under such section4 7c7 ,coverage ,except as otherwise provided in this section1 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 7#db ,u4,s4,c4 #acie;j et seq47 and such payment shall be made in the same manner as payment is provided for such a product under such part4 7d7 ,additional payment 7#a7 ,in general ,subject to paragraphs 7#b7 and 7#c71 in addition to the amount of payment that would otherwise be made under part ,b of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;j et seq47 for a biosimilar biological product furnished or dispensed by a participating provider to a ,medicare beneficiary under the demonstration project1 there shall be made an additional payment1 in an amount determined by the ,secretary1 that reflects a portion of any difference between such amount of payment under such part1 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 beneficiary4 7#b7 ,medicare ,beneficiary ,coinsurance ,liability ,the additional payment provided under paragraph 7#a7 shall not be taken into account when determining the amount of coinsurance under section #ahcc7;a77#a77,s7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77#a77,s77 for a biosimilar biological product furnished or dispensed to a ,medicare beneficiary by a participating provider under the demonstration project4 ,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 biological4 7#c7 ,exception to ,additional ,payment ,a participating provider may only receive the additional payment described in paragraph 7#a7 with respect to a biosimilar biological product furnished or dispensed by the participating provider to a ,medicare beneficiary under the demonstration project1 if the amount of payment determined under section #ahdg;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7 for the biosimilar biologic product is less than the amount of payment determined under such section for the reference biological product4 7e7 ,waiver authority ,the ,secretary may waive such requirements of titles ,,xi and ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acja et seq41 #acie et seq47 as may be necessary to carry out the demonstration project4 7f7 ,data collection 7#a7 ,in general ,the ,secretary shall collect data on the sex1 race1 ethnicity1 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 project4 7#b7 ,consideration ,the ,secretary shall take into account data collected under paragraph 7#a7 in evaluating the demonstration project in each of the reports submitted under subsection 7g74 7g7 ,reports 7#a7 ,interim evaluation and report ,not later than #c years after the date of enactment of this ,act1 the ,secretary shall submit to ,congress a report that contains an analysis of the appropriateness of expanding or extending the demonstration project and1 to the extent such analysis determines such an expansion or extension appropriate1 recommendations for such expansion or extension1 respectively4 7#b7 ,evaluation and report ,not later than #a year after the date of completion of the demonstration project1 the ,secretary shall submit to ,congress a report that contains a final analysis of the project and recommendations described in paragraph 7#a74 7h7 ,definitions ,in this section3 7#a7 ,biosimilar biological product ,the term biosimilar biological product has the meaning given that term in section #ahdg;,a7c77#f77;,h7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,h774 7#b7 ,demonstration project ,the term demonstration project means the demonstration project conducted under this section4 7#c7 ,eligible provider ,the term eligible provider means a provider of services or supplier that is eligible to receive payment under part ,b of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;j et seq47 for furnishing or dispensing a biosimilar biological product4 7#d7 ,medicare beneficiary ,the term ,medicare beneficiary means an individual who is enrolled for benefits under such part4 7#e7 ,participating provider ,the term participating provider means an eligible provider that has been selected for participation under the project under subsection 7b77#b7 and with respect to whom such participation has not been terminated4 7#f7 ,reference biological product ,the term reference biological product has the meaning given that term in section #ahdg;,a7c77#f77;,i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,i774 7#g7 ,secretary ,the term ,secretary means the ,secretary of ,health and ,human ,services4