,,ii #aahth ,,congress #b;d ,session ,s4 #cicd ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #ad1 #bjbd,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 require the ,secretary of ,health and ,human ,services 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 #bjbc4 #b4 ,demonstration project to increase access to biosimilar biological products under the ,medicare program 7a7 ,establishment ,subject to subsection 7f71 beginning not later than #a year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall establish and implement a #c-year nationwide demonstration project under part ,b of title ,,xviii of the ,social ,security ,act to evaluate the benefits of providing a shared savings payment for biosimilar biological products furnished under such part4 7b7 ,participation 7#a7 ,in general ,participation under the demonstration project shall be voluntary1 and a participating provider may terminate participation at any time and the ,secretary may terminate the participation of such a provider at any time4 7#b7 ,application and selection ,to participate under 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 ,clarification ,participation under the demonstration project shall not preclude eligible providers 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 ,oncology ,care ,first ,model1 or impact eligible providers metrics or expenditures within other models 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 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 ,under the demonstration project1 subject to paragraph 7#c71 in addition to the payment that would otherwise be made under part ,b of title ,,xviii of the ,social ,security ,act for a biosimilar biological product furnished or dispensed by a participating provider to a ,medicare beneficiary1 there shall be made an additional payment1 in an amount determined by the ,secretary1 that is based on the difference1 if any1 7or portion of such difference7 between the costs to the provider in furnishing the biosimilar biological product and the costs to the provider if the provider had furnished the reference biological product4 7#b7 ,no increase to ,medicare coinsurance ,the additional payment described under paragraph 7#a7 shall not increase a ,medicare beneficiary's cost-sharing liability1 as described in section #ahcc of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel74 7#c7 ,exception ,an eligible provider may only receive the additional payment described in paragraph 7#a71 with respect to a biosimilar biological product1 if the payment amount under section #ahdg;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7 for such product is less than the payment amount under part ,b of title ,,xviii of such ,act for the reference biological product4 7e7 ,waiver authority ,the ,secretary may waive such requirements of title ,,xviii of the ,social ,security ,act as may be necessary to carry out the demonstration project1 except the ,secretary may not increase the cost-sharing that would otherwise1 without application of this section1 be applied to an individual under section #ahcc of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel74 7f7 ,ensuring no increase in ,medicare expenditures ,the ,secretary may not implement the demonstration project described in subsection 7a7 unless the ,chief ,actuary of the ,centers for ,medicare ,medicaid ,services certifies that implementation of such model will not result in an increase in expenditures under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq474 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 ,final evaluation and report ,not later than one 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 ,demonstration project ,the term demonstration project means the demonstration project conducted under this ,act4 7#b7 ,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 #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 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 for furnishing or dispensing biosimilar biological products4 7#d7 ,medicare beneficiary ,the term ,medicare beneficiary means an individual who is enrolled for benefits under part ,b of title ,,xviii of the ,social ,security ,act4 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 means the biological product licensed under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 that is referred to in the application described in paragraph 7#b7 of the biosimilar biological product4 #c4 ,extending eligibility for certain payment increases for biosimilar biological products under the ,medicare program ,section #ahdg;,a7b77#h77;,b77ii77,,ii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7b77#h77;,b77ii77,,ii77 is amended by striking #bjbg and inserting #bjcb4