,i #aag? ,,congress #b;d ,session ,h4 ,r4 #icba ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,novemb] #af1 #bjbb,ms4 ,spei] 7= h]self1 ,mr4 ,nadl]1 & ,ms4 ,port]7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,public ,heal? ,s]vice ,act to provide = ! developm5t & publication ( indep5d5t value assessm5ts = drugs1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,indep5d5t ,drug ,value ,assessm5t ,act4 #b4 ,indep5d5t value assessm5ts = drugs ,"p ,d ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#ba ,u4,s4,c4 #bed;b et seq47 is am5d$ by add+ at ! end ! foll[+3 ,,xiii ,indep5d5t value assessm5ts = drugs #cdj;,j4 ,indep5d5t value assessm5ts 7a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,assi/ant ,secret>y = ,plann+ & ,evaluation1 %all complete1 by contract "u subsection 7e71 an indep5d5t value assessm5t = any drug-- 7#a7 t is approv$ "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 or lic5s$ "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act1 on or aft] ! day t is #a ye> aft] ! date ( enactm5t ( ?is section2 or 7#b7 = :i* a new indication or use is approv$ or lic5s$ "u su* section #eje7;c7 or #cea7;a7 on or aft] su* day4 7b7 ,timel9e ,! ,secret>y %all ensure t an indep5d5t value assessm5t requir$ by subsection 7a7 is complet$ n lat] ?an #ij days aft] ! effective date ( ! approval or lic5sure involv$4 7c7 ,previ\sly approv$ drugs ,! ,secret>y %all-- 7#a7 n lat] ?an #e ye>s aft] ! date ( enactm5t ( ?is section1 complete1 by contract "u subsection 7e71 an indep5d5t value assessm5t = no few] ?an #be drugs n describ$ 9 subsection 7a72 & 7#b7 9 select+ drugs = assessm5t "u p>agraph 7#a71 prioritize-- 7,a7 drugs 9 ! top #ce p]c5t ( exp5ditures = p>ticul> drugs "u "p ,b or ,d ( title ,,xviii ( ! ,social ,security ,act2 & 7,b7 drugs approv$ z a break?r\gh !rapy pursuant to section #ejf7;a71 z a fa/ track product pursuant to section #ejf7;b71 or pursuant to accel]at$ approval "u section #ejf7;c74 7d7 ,publication ,! ,secret>y %all publi% ea* indep5d5t value assessm5t prep>$ "u subsection 7a7 or 7c7 on ! public website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices )\t modification1 except t ! ,secret>y may r$act any confid5tial or propriet>y in=mation 9 accordance ) applicable law4 7e7 ,contracts 7#a7 ,9 g5]al ,to ! ext5t & 9 ! am\nts made available 9 advance 9 appropriations ,acts1 ! ,secret>y %all ent] into a contract ) an eligible entity to develop an indep5d5t value assessm5t "u ?is section4 7#b7 ,eligible entities ,to be eligible to prep>e an indep5d5t value assessm5t "u ?is section1 an entity-- 7,a7 %all be a nonpr(it organization1 a univ]sity1 a f$]ally fund$ rese>* & developm5t c5t]1 or ano!r type ( organization t is det]m9$ by ! ,secret>y to be capable ( develop+ su* an indep5d5t value assessm5t2 7,b7 %all n be an entity t-- 7i7 is involv$ 9 ! manufactur+1 rese>*1 & developm5t ( drugs2 or 7ii7 op]ates fully insur$ & self-insur$ heal? plans1 ph>maceutical b5efit manag]s1 or o!r entities t pay = drugs2 & 7,c7 %all be1 z det]m9$ by ! ,secret>y1 indep5d5t ( any o!r entity describ$ 9 subp>agraph 7,b74 7#c7 ,in=mation 7,a7 ,in=mation 9 possession ( ,,hhs ,! ,secret>y %all ensure t any organization "u contract to develop an indep5d5t value assessm5t "u ?is section has access to all ( ! in=mation 9 ! possession ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices t is necess>y to complete ! assessm5t4 7,b7 ,in=mation 9 possession ( manufactur] ,! manufactur] ( any drug = :i* an indep5d5t value assessm5t is be+ develop$ "u ?is section %all1 at ! reque/ ( ! ,secret>y or ! entity "u contract to develop ! indep5d5t value assessm5t1 provide to ! ,secret>y or entity1 z applicable1 in=mation 9 ! possession ( ! manufactur] t is necess>y to complete ! assessm5t4 7,c7 ,additional in=mation ,an entity "u contract to develop an indep5d5t value assessm5t "u ?is section = a drug %all (f] manufactur]s1 pati5t advocates1 cl9ical exp]ts1 & memb]s ( ! public an opportunity to submit additional in=mation & analyses = consid]ation be=e ! indep5d5t value assessm5t is complete4 7f7 ,prohibitions ,! ,secret>y %all prohibit ! use 9 any indep5d5t value assessm5t "u ?is section (-- 7#a7 any analysis bas$ on ! quality-adju/$ life ye>2 & 7#b7 any rese>* f9d+s t d n weigh ! value ( ea* ye> ( life ga9$ f treatm5t equally = all pati5ts no matt] _! sev]ity ( illness1 age1 or pre-exi/+ disability4 7g7 ,def9itions ,9 ?is section3 7#a7 ,! t]m indep5d5t value assessm5t means an economic analysis t-- 7,a7 analyzes ! b5efits ( a p>ticul> drug = ! av]age pati5t & = v>i\s subgr\ps ( pati5ts1 z det]m9$ by ! ,secret>y1 & ! b5efits ( ! drug on a /&alone basis & 9 comp>ison ) o!r approv$ treatm5ts1 includ+-- 7i7 an economic analysis ( direct b5efits to ! pati5t1 includ+ to ! quality & duration ( life ( ! pati5t2 & 7ii7 an economic analysis ( indirect b5efits1 includ+-- 7,i7 b5efits to ! e>n+s capacity ( ! pati5t2 7,,ii7 b5efits to family memb]s1 employ]s1 & c>egiv]s ( ! pati5t2 & 7,,iii7 b5efits to ! heal? c>e sy/em1 includ+ sav+s to public- & private-sector pay]s result+ f pot5tial use ( heal? s]vices t is avoid$ due to ! b5efits ( ! p>ticul> drug2 & 7,b7 includes an e/imate ( a price1 price range1 or a propos$ value-bas$ paym5t arrangem5t = ! p>ticul> drug t is comm5surate ) ! economic b5efits ( ! p>ticul> drug1 includ+ a li/ & explanation ( ! factors t support ! e/imat$ price1 price range1 or propos$ value-bas$ paym5t arrangem5t4 7#b7 ,! t]m value-bas$ paym5t arrangem5t-- 7,a7 means a =m ( paym5t = a drug1 o!r ?an a fix$ paym5t p] dose or o!r /&>d adm9i/ration ( ! drug1 t takes into consid]ation ! effectiv5ess ( ! drug2 & 7,b7 may include an ov]all paym5t = a c\rse ( treatm5t ) ! drug1 an ov]all paym5t to cov] all indicat$ uses ( ! drug = a p>ticul> population1 or ano!r approa* to paym5t1 any ( :i* may include a provision to v>y ! am\nt ( ! paym5t bas$ on ! effectiv5ess ( ! drug = an individual or a population1 z ! case may be4 4