,i #aag? ,,congress #b;d ,session ,h4 ,r4 #gchi ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,april #d1 #bjbb,mr4 ,s*rad] 7= himself1 ,mr4 ,gu?rie1 & ,mr4 ,mull97 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,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$icaid ,v,b,ps = ,pati5ts ,act or ! ,,mvp ,act4 #b4 ,f9d+s ,! ,congress f9ds ! foll[+3 7#a7 ,value-bas$ paym5t 7,,vbp7 arrangem5ts are a critical compon5t ( a mod]niz$ reimbursem5t sy/em4 ,by codify+ elem5ts ( ! rec5tly f9aliz$ 8multiple be/ price0 policies ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 ,congress is en%r9+ a su/a9able & flexible paym5t approa* = innovative treatm5ts & cures4 7#b7 ,_m ( ^! treatm5ts1 includ+ g5e !rapies1 are diff]5t f traditional ph>maceutical & biologic products 9 t !y c (f] long-la/+--sometimes lifelong--b5efits = pati5ts & long-t]m value = ! heal? c>e sy/em alike4 7#c7 ,!re are hundr$s ( innovative1 curative1 & life-*ang+ treatm5ts curr5tly 9 developm5t 9 ! ,unit$ ,/ates4 ,h[ev]1 ! curr5t reimbursem5t /ructure 0 n design$ ) ^! !rapies 9 m9d1 & all[+ = innovative paym5t arrangem5ts w spur great] developm5t & access to future cures & treatm5ts4 7#d7 ,m$icaid is curr5tly los+ out on innovative ways to ensure pati5ts h access to ^! treatm5ts1 :ile private payors cont9ue to see ! value provid$ ?r\gh flexible paym5t arrangem5ts4 7#e7 ,,vbp arrangem5ts include ! ability to pay bas$ on evid5ce-bas$ outcomes &1 ov] "t1 spread+ ! risk across all entities involv$ 9 ! contract & ensur+ t ^! (t5 co/ly treatm5ts are accessible4 7#f7 ,evid5ce-bas$ outcomes c demon/rate decreas$ co/ to ! heal? sy/em & to pati5ts1 includ+ r$uc$ hospitalizations & l[] utilization ( o!r heal? c>e exp5ditures1 includ+ lab "w1 o!r m$ications1 & (fice visits4 7#g7 ,by all[+ ,v,b,ps 9 ,m$icaid1 ! heal? c>e sy/em w cont9ue to move t[>ds quality ov] quantity1 hold+ manufactur]s & provid]s acc\ntable = ! be/ treatm5t = e pati5t4 #c4 ,codify+ value-bas$ pur*as+ arrangem5ts "u ,m$icaid & re=ms relat$ to price report+ "u su* arrangem5ts 7a7 ,codify+ ! ,,vbp rule ,! revision to section #ddg4eje7;a7 ( title #db1 ,code ( ,f$]al ,regulations relat$ to ! inclusion ( v>y+ be/ price po9ts available "u a value-bas$ pur*as+ arrangem5t 7z def9$ 9 section #aibg7k77#ab7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#ab71 z add$ by subsection 7d7 ( ?is section7 = a s+le dosage =m & /r5g? ( a cov]$ outpati5t drug if a manufactur] (f]s su* pric+ /ructure to all ,/ates1 z publi%$ by ! ,secret>y ( ,heal? & ,human ,s]vices on ,decemb] #ca1 #bjbj 7#he ,f$]al ,regi/] #hgjjj71 %all h ! =ce & effect ( law4 7b7 ,qu>t]ly report+ obligation 7#a7 ,9 g5]al ,section #aibg7;b77#c77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,a77 is am5d$-- 7,a7 9 clause 7iv71 by /rik+ at ! end &2 7,b7 9 clause 7v71 by /rik+ at ! end ! p]iod & ins]t+ 2 &2 7,c7 by ins]t+ aft] clause 7v7 ! foll[+ new clause3 7vi7 = cal5d> qu>t]s beg9n+ on or aft] ,july #a1 #bjbb1 9 conjunction ) report+ requir$ "u clause 7i71 9 ! case ( a cov]$ outpati5t drug t is sold "u a value-bas$ pur*as+ arrangem5t 7z def9$ 9 subsection 7k77#ab77 made available by ! manufactur] to a ,/ate plan-- 7,i7 ! pric+ /ructure = su* drug bas$ on pre-def9$ outcomes or measures specifi$ 9 su* value-bas$ pur*as+ arrangem5t2 & 7,,ii7 ! be/ price = su* cov]$ outpati5t drug outside ( a value-bas$ pur*as+ arrangem5t1 :i* 9 ! ev5t su* drug is sold exclusively ?r\gh su* an arrangem5t1 means ! l[e/ price available net ( any disc\nts or (fsets t are unrelat$ to a refund1 rebate1 reimbursem5t1 free item1 )hold+1 or repaym5t made "u a value-bas$ pur*as+ arrangem5t = su* drug4 2 & 7,d7 by add+ at ! end ( ! flu% left matt] at ! end ! foll[+ new s5t5ce3 ,in=mation report$ ) respect to a rebate p]iod "u clause 7i77,i7 relat+ to av]age manufactur] price & clause 7i77,,ii7 relat+ to be/ price %all be updat$ = su* rebate p]iod if1 subsequ5t to ! date su* in=mation 0 report$1 cumulative disc\nts1 rebates1 or o!r arrangem5ts adju/ su* av]age price actually realiz$ or be/ price available to ! ext5t t su* cumulative disc\nts1 rebates1 or o!r arrangem5ts are n exclud$ "u ?is section f ! det]m9ation ( av]age manufactur] price or be/ price4 7#b7 ,rules ( con/ruction ,no?+ 9 ! am5dm5ts made by p>agraph 7#a7 %all be con/ru$ z-- 7,a7 requir+-- 7i7 a ,/ate to ent] into a value-bas$ pur*as+ arrangem5t ) a manufactur] = a cov]$ outpati5t drug2 or 7ii7 a manufactur] to ent] into a value-bas$ pur*as+ arrangem5t ) a ,/ate = a cov]$ outpati5t drug2 7,b7 prohibit+ a manufactur] f treat+ a value-bas$ pur*as+ arrangem5t z a bundl$ sale2 or 7,c7 preclud+ ! execution ( a supplem5tal rebate agreem5t1 z provid$ 9 section #aibg7;a77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;a77#a771 = a cov]$ outpati5t drug sold "u a value-bas$ pur*as+ arrangem5t4 7c7 ,def9ition ( av]age manufactur] price ,section #aibg7k77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#a77 is am5d$-- 7#a7 9 subp>agraph 7,b77i7-- 7,a7 9 subclause 7,,iv71 by /rik+ at ! end &2 7,b7 9 subclause 7,v71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+ new subclause3 7,,vi7 9 accordance ) subsection 7b77#c77;,a77vi71 ) respect to su* cov]$ outpati5t drug t is sold "u a value-bas$ pur*as+ arrangem5t 7z def9$ 9 p>agraph 7#ab77 dur+ ! rebate p]iod-- 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* agreem5t 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 ! 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* agreem5t1 su* price %all be det]m9$ z if ! aggregate price p] ! t]ms ( ! agreem5t 0 paid 9 full 9 ! fir/ in/allm5t dur+ ! rebate p]iod4 4 7d7 ,def9ition ( value-,bas$ pur*as+ arrangem5t ,section #aibg7k7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77 %all be am5d$ by add+ at ! end ! foll[+ p>agraph3 7#ab7 ,value-,bas$ ,pur*as+ ,arrangem5t ,! t]m value-bas$ pur*as+ arrangem5t means an arrangem5t or agreem5t int5d$ to align pric+ or paym5ts to an obs]v$ or expect$ !rapeutic or cl9ical value 9 a select population & includes-- 7,a7 evid5ce-bas$ measures1 :i* sub/antially l9k ! co/ ( a cov]$ outpati5t drug to exi/+ evid5ce ( effectiv5ess & pot5tial value = specific uses ( t product2 or 7,b7 outcomes-bas$ measures1 :i* sub/antially l9k paym5t = ! cov]$ outpati5t drug to t ( ! drug's actual p]=mance 9 pati5t or a population1 or a r$uction 9 o!r m$ical exp5ses4 4 7e7 ,effective date ,! am5dm5ts made by ?is section %all apply beg9n+ on ,july #a1 #bjbb4 #d4 ,remun]ation 9 ,f$]al heal? c>e programs 7a7 ,9 g5]al ,section #aabh;,b7b77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;b7b77#c77 is am5d$-- 7#a7 9 subclause 7,j7-- 7,a7 by mov+ ! left m>g9 ( su* subp>agraph #b ems to ! left2 & 7,b7 by /rik+ & aft] ! semicolon at ! end2 7#b7 9 subclause 7,k7-- 7,a7 by mov+ ! left m>g9 ( su* subp>agraph #b ems to ! left2 & 7,b7 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+ new subp>agraph3 7,l7 any remun]ation provid$ by a manufactur] or ?ird p>ty on behalf ( a manufactur] to a plan "u a value-bas$ pur*as+ arrangem5t 7z def9$ 9 section #aibg7k77#ab77 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 ,effective date ,! am5dm5ts made by ?is section %all apply beg9n+ on ,july #a1 #bjbb4 #e4 ,,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#ab77 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$icaid drug rebate program "u section #aibg ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h71 ! #cdj;,b drug pric+ program "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b71 & "p ,b ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;j et seq471 includ+ compliance ) su* programs2 & 7#b7 us+ data submitt$ pursuant to clause 7vi7 ( section #aibg7;b77#c77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,a771 z add$ by section #c ( ?is ,act1 analyze all ! types ( value-bas$ pur*as+ arrangem5t pric+ /ructures1 :i* /ructures are work+ well 7z measur$ by price & ease ( implem5t+71 & :i* ne$ improvem5t4 7b7 ,report ,n lat] ?an ,june #cj1 #bjbg1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report conta9+ ! results ( ! /udy conduct$ "u subsection 7a74