,i #aai? ,,congress #b;d ,session ,h4 ,r4 #ghga ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,m>* #i1 #bjbf,mr4 ,gu?rie 7= himself1 ,mr4 ,au*9closs1 ,mrs4 ,mill]-,meeks1 ,mr4 ,joyce ( ,p5nsylvania1 ,mr4 ,pet]s1 & ,mr4 ,davis ( ,nor? ,c>ol9a7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committee on ,ways & ,means1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to am5d title ,,xix ( ! ,social ,security ,act to codify value-bas$ pur*as+ arrangem5ts "u ! ,m$icaid program & re=ms relat$ to price report+ "u su* arrangem5ts1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,m$icaid ,v,b,ps = ,pati5ts ,act or ! ,,mvp ,act4 #b4 ,codify+ value-bas$ pur*as+ arrangem5ts "u ,m$icaid & re=ms relat$ to price report+ "u su* arrangem5ts 7a7 ,codify+ multiple be/ price po9ts 7#a7 ,9 g5]al ,section #aibg7;c77#a77;,c77ii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#a77;,c77ii77 is am5d$-- 7,a7 9 subclause 7,,iii71 by add+ a semicolon at ! end2 7,b7 9 subclause 7,,iv71 by /rik+ & at ! end2 7,c7 9 subclause 7,v71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,d7 by add+ at ! end ! foll[+ new subclause3 7,,vi7 may include multiple be/ price po9ts = a s+le dosage =m & /r5g? ( a drug ( a manufactur] subject to a value-bas$ pur*as+ arrangem5t 7z def9$ 9 subsection 7k77#ab771 b only if su* manufactur] (f]s su* arrangem5t to all ,/ates4 4 7#b7 ,rule ( con/ruction ,no?+ 9 ! am5dm5ts made by ?is subsection may be con/ru$ to prohibit a manufactur] f treat+ a value-bas$ pur*as+ arrangem5t z a bundl$ sale4 7b7 ,def9ition ( av]age manufactur] price 7#a7 ,9 g5]al ,section #aibg7k77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#a77 is am5d$-- 7,a7 9 subp>agraph 7,b77i7-- 7i7 9 subclause 7,,iv71 by add+ a semicolon at ! end2 7ii7 9 subclause 7,,vii71 by /rik+ at ! end &2 7iii7 9 subclause 7,,viii71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7iv7 by add+ at ! end ! foll[+ new subclause3 7,,ix7 ) respect to a cov]$ outpati5t drug t is sold "u a value-bas$ pur*as+ arrangem5t 7z def9$ 9 p>agraph 7#ab77 dur+ ! rebate p]iod1 includ+ su* a drug t is an inhalation1 infusion1 in/ill$1 implant$1 or injectable drug t is n g5]ally disp5s$ ?r\gh a retail community ph>macy-- 7aa7 a refund1 rebate1 reimbursem5t1 or free goods f ! manufactur] or ?ird p>ty on behalf ( ! manufactur]2 or 7bb7 ! )hold+ or r$uction ( a paym5t to ! manufactur] or ?ird p>ty on behalf ( ! manufactur]2 t is trigg]$ by a pati5t :o fails to a*ieve outcomes or measures def9$ "u ! t]ms ( su* value-bas$ pur*as+ arrangem5t dur+ ! p]iod = :i* su* arrangem5t is effective4 2 & 7,b7 by add+ at ! end ! foll[+ new subp>agraph3 7,d7 ,special rule = c]ta9 value-bas$ pur*as+ arrangem5ts ,= purposes ( subp>agraph 7,a71 9 det]m9+ ! av]age price paid to a manufactur] = a cov]$ outpati5t drug t is sold "u a value-bas$ pur*as+ arrangem5t 7z def9$ 9 p>agraph 7#ab77 t provides t paym5t = su* drug is made 9 in/allm5ts ov] ! c\rse ( su* arrangem5t1 su* price %all be det]m9$ z if ! aggregate price p] ! t]ms ( ! arrangem5t 7 paid 9 full 9 ! fir/ in/allm5t dur+ ! rebate p]iod4 4 7#b7 ,rulemak+ ,n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all implem5t ! am5dm5ts made by ?is subsection ?r\gh rulemak+4 7c7 ,def9ition ( value-,bas$ pur*as+ arrangem5t ,section #aibg7k7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77 is am5d$ by add+ at ! end ! foll[+ p>agraph3 7#ab7 ,value-,bas$ ,pur*as+ ,arrangem5t ,! t]m value-bas$ pur*as+ arrangem5t has ! mean+ giv5 su* t]m 9 section #ddg4ejb ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation74 4 #c4 ,calculation ( av]age sales price "u ,m$ic>e ,section #ahdg;,a7c77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#c77 is am5d$-- 7#a7 by /rik+ ,9 calculat+ & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 9 calculat+ 2 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,b7 ,c]ta9 remun]ation "u value-bas$ pur*as+ arrangem5ts exclud$ ,9 calculat+ ! manufactur]'s av]age sales price "u ?is subsection = a drug or biological t is sold "u a value-bas$ pur*as+ arrangem5t 7z def9$ 9 section #aibg7k77#ab77 & ) respect to :i* ! manufactur] ( su* drug or biological has elect$ to include multiple be/ price po9ts 7z describ$ 9 section #aibg7;c77#a77;,c77ii77,,vi77 9 report+ ! be/ price ( su* drug "u section #aibg7;b71 su* manufactur]'s av]age sales price %all n include any am\nt t is exclud$ f ! calculation ( ! av]age manufactur] price ( su* drug or biological "u section #aibg7k77#a77;,b77i77,,ix74 4 #d4 ,guidance on value-bas$ pur*as+ arrangem5ts = inpati5t drugs "u ,m$icaid ,n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue guidance to ,/ate ,m$icaid ag5cies on ! option ( ent]+ into a value-bas$ pur*as+ arrangem5t 7z def9$ 9 section #aibg7k77#ab7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#ab777 ) manufactur]s = drugs or biological products provid$ z "p (1 or z incid5t to & 9 ! same sett+ z1 inpati5t hospital s]vices furni%$ "u a ,/ate plan "u title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq471 or "u a waiv] ( su* plan1 :]e su* drugs or biological products are reimburs$ directly & n paid = z "p ( paym5t = su* inpati5t hospital s]vices1 includ+ guidance on h[ multiple ,/ates may ent] into agreem5ts ) "o ano!r & ) manufactur]s :i* p]mit ! transf] ( funds betwe5 ! p>ticipat+ ,/ates s t individuals :o reside 9 a ,/ate diff]5t f ! ,/ate 9 :i* !y receive a drug subject to a value-bas$ pur*as+ arrangem5t z an inpati5t may be treat$ z if !y receiv$ su* drug 9 ! ,/ate 9 :i* !y reside4 #e4 ,exception "u ! antikickback /atute 7a7 ,9 g5]al ,section #aabh;,b7b77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;b7b77#c77 is am5d$-- 7#a7 9 subp>agraph 7,j71 by mov+ ! left m>g9 ( su* subp>agraph #b ems to ! left2 7#b7 9 subp>agraph 7,k7-- 7,a7 by mov+ ! left m>g9 ( su* subp>agraph #b ems to ! left2 & 7,b7 by /rik+ & at ! end2 7#c7 9 subp>agraph 7,l77iii71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7#d7 by add+ at ! end ! foll[+ new subp>agraph3 7,m7 any remun]ation provid$ by a manufactur] or ?ird p>ty on behalf ( a manufactur] to a ,/ate "u a value-bas$ pur*as+ arrangem5t 7z def9$ 9 section #aibg7k77#ab77 "u a ,/ate plan "u title ,,xix 7or waiv] ( su* plan7 9 ! case a pati5t fails to a*ieve outcomes or measures def9$ 9 su* arrangem5t foll[+ ! adm9i/ration ( a cov]$ outpati5t drug 7z def9$ 9 section #aibg7k77#b774 4 7b7 ,rulemak+ ,n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all ?r\gh rulemak+ implem5t ! am5dm5ts made by ?is section4 #f4 ,,gao /udy & report on use ( value-bas$ pur*as+ arrangem5ts 7a7 ,/udy ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy on ! ext5t to :i* value-bas$ pur*as+ arrangem5ts 7z def9$ 9 section #aibg7k77#ab7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#ab777 facilitate pati5t access to cov]$ outpati5t drugs1 improve pati5t outcomes1 l[] ov]all heal? sy/em co/s1 & l[] co/s = pati5ts 9 ,f$]al heal? c>e programs4 ,9 conduct+ su* /udy1 ! ,comptroll] ,g5]al %all-- 7#a7 /udy ! impact ( ?is ,act on-- 7,a7 access to trans=mative !rapies1 includ+ r>e disease g5e !rapies1 g5]ally2 7,b7 mitigat+ socioeconomic disp>ities 9 access+ cov]$ outpati5t drugs sold "u value-bas$ pur*as+ arrangem5ts ?r\gh its requirem5t t ,/ate ,m$icaid programs h access to ! same value-bas$ pur*as+ arrangem5t pric+ /ructure t are available 9 ! comm]cial m>ket = su* drugs2 7,c7 ! ,m$icaid drug rebate program "u section #aibg ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h71 ! #cdj;,b drug pric+ program "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b71 & "p ,b ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;j et seq471 includ+ compliance ) su* programs2 7,d7 exp5ditures "u ,/ate ,m$icaid programs2 & 7,e7 prices = su* drugs "u ! ,m$icaid program 9 ,/ates t d n ent] into su* arrangem5ts2 7#b7 analyze all ! types ( value-bas$ pur*as+ arrangem5t pric+ /ructures1 :i* /ructures are work+ well 7z measur$ by price & ease ( implem5t+71 & :i* ne$ improvem5t2 & 7#c7 /udy ! pot5tial long-t]m sav+s = ,/ates t ent] into su* arrangem5ts "u ,/ate ,m$icaid programs4 7b7 ,report ,n lat] ?an ,june #cj1 #bjbi1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report conta9+ ! results ( ! /udy conduct$ "u subsection 7a74