,,ii #aah? ,,congress #b;d ,session ,s4 #cicd ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,m>* #ad1 #bjbd,mr4 ,cornyn 7= himself & ,mr4 ,b5net7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,f9ance ,a ,,bill ,to require ! ,secret>y ( ,heal? & ,human ,s]vices to e/abli% a demon/ration project to increase access to biosimil> biological products "u ! ,m$ic>e program4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,increas+ ,access to ,biosimil>s ,act ( #bjbc4 #b4 ,demon/ration project to increase access to biosimil> biological products "u ! ,m$ic>e program 7a7 ,e/abli%m5t ,subject to subsection 7f71 beg9n+ n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all e/abli% & implem5t a #c-ye> nationwide demon/ration project "u "p ,b ( title ,,xviii ( ! ,social ,security ,act to evaluate ! b5efits ( provid+ a %>$ sav+s paym5t = biosimil> biological products furni%$ "u su* "p4 7b7 ,p>ticipation 7#a7 ,9 g5]al ,p>ticipation "u ! demon/ration project %all be volunt>y1 & a p>ticipat+ provid] may t]m9ate p>ticipation at any "t & ! ,secret>y may t]m9ate ! p>ticipation ( su* a provid] at any "t4 7#b7 ,application & selection ,to p>ticipate "u ! demon/ration project1 an eligible provid] %all submit to ! ,secret>y an application 9 su* =m & mann] & conta9+ su* in=mation z specifi$ by ! ,secret>y4 ,ea* eligible provid] :o submits su* an application %all be select$ by ! ,secret>y = p>ticipation "u ! demon/ration project4 7#c7 ,cl>ification ,p>ticipation "u ! demon/ration project %all n preclude eligible provid]s f also p>ticipat+ 9 any model au?oriz$ "u section #aaae;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acae;a71 includ+ ! ,oncology ,c>e ,model & ,oncology ,c>e ,fir/ ,model1 or impact eligible provid]s metrics or exp5ditures )9 o!r models au?oriz$ "u su* section4 7c7 ,cov]age ,except z o!rwise provid$ 9 ?is section1 paym5t may be made "u ! demon/ration project = a biosimil> biological product only if su* product is cov]$ "u "p ,b ( title ,,xviii ( ! ,social ,security ,act & su* paym5t %all be made 9 ! same mann] z paym5t is provid$ = su* a product "u su* "p4 7d7 ,additional paym5t 7#a7 ,9 g5]al ,"u ! demon/ration project1 subject to p>agraph 7#c71 9 addition to ! paym5t t w\ld o!rwise be made "u "p ,b ( title ,,xviii ( ! ,social ,security ,act = a biosimil> biological product furni%$ or disp5s$ by a p>ticipat+ provid] to a ,m$ic>e b5efici>y1 !re %all be made an additional paym5t1 9 an am\nt det]m9$ by ! ,secret>y1 t is bas$ on ! diff]5ce1 if any1 7or portion ( su* diff]5ce7 betwe5 ! co/s to ! provid] 9 furni%+ ! biosimil> biological product & ! co/s to ! provid] if ! provid] _h furni%$ ! ref]5ce biological product4 7#b7 ,no increase to ,m$ic>e co9surance ,! additional paym5t describ$ "u p>agraph 7#a7 %all n increase a ,m$ic>e b5efici>y's co/-%>+ liability1 z describ$ 9 section #ahcc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel74 7#c7 ,exception ,an eligible provid] may only receive ! additional paym5t describ$ 9 p>agraph 7#a71 ) respect to a biosimil> biological product1 if ! paym5t am\nt "u section #ahdg;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7 = su* product is less ?an ! paym5t am\nt "u "p ,b ( title ,,xviii ( su* ,act = ! ref]5ce biological product4 7e7 ,waiv] au?ority ,! ,secret>y may waive su* requirem5ts ( title ,,xviii ( ! ,social ,security ,act z may be necess>y to c>ry out ! demon/ration project1 except ! ,secret>y may n increase ! co/-%>+ t w\ld o!rwise1 )\t application ( ?is section1 be appli$ to an individual "u section #ahcc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel74 7f7 ,ensur+ no increase 9 ,m$ic>e exp5ditures ,! ,secret>y may n implem5t ! demon/ration project describ$ 9 subsection 7a7 unless ! ,*ief ,actu>y ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices c]tifies t implem5tation ( su* model w n result 9 an increase 9 exp5ditures "u title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq474 7g7 ,reports 7#a7 ,int]im evaluation & report ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all submit to ,congress a report t conta9s an analysis ( ! appropriat5ess ( exp&+ or ext5d+ ! demon/ration project &1 to ! ext5t su* analysis det]m9es su* an expansion or ext5sion appropriate1 recomm5dations = su* expansion or ext5sion1 respectively4 7#b7 ,f9al evaluation & report ,n lat] ?an "o ye> aft] ! date ( completion ( ! demon/ration project1 ! ,secret>y %all submit to ,congress a report t conta9s a f9al analysis ( ! project & recomm5dations describ$ 9 p>agraph 7#a74 7h7 ,def9itions ,9 ?is section3 7#a7 ,demon/ration project ,! t]m demon/ration project means ! demon/ration project conduct$ "u ?is ,act4 7#b7 ,biosimil> biological product ,! t]m biosimil> biological product means a biological product approv$ "u an abbreviat$ application = a lic5se ( a biological product t relies 9 "p on data or in=mation 9 an application = ano!r biological product lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 7#c7 ,eligible provid] ,! t]m eligible provid] means a provid] ( s]vices or suppli] t is eligible to receive paym5t "u "p ,b ( title ,,xviii ( ! ,social ,security ,act = furni%+ or disp5s+ biosimil> biological products4 7#d7 ,m$ic>e b5efici>y ,! t]m ,m$ic>e b5efici>y means an individual :o is enroll$ = b5efits "u "p ,b ( title ,,xviii ( ! ,social ,security ,act4 7#e7 ,p>ticipat+ provid] ,! t]m p>ticipat+ provid] means an eligible provid] t has be5 select$ = p>ticipation "u ! project "u subsection 7b77#b7 & ) respect to :om su* p>ticipation has n be5 t]m9at$4 7#f7 ,ref]5ce biological product ,! t]m ref]5ce biological product means ! biological product lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 t is ref]r$ to 9 ! application describ$ 9 p>agraph 7#b7 ( ! biosimil> biological product4 #c4 ,ext5d+ eligibility = c]ta9 paym5t increases = biosimil> biological products "u ! ,m$ic>e program ,section #ahdg;,a7b77#h77;,b77ii77,,ii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7b77#h77;,b77ii77,,ii77 is am5d$ by /rik+ #bjbg & ins]t+ #bjcb4