,,ii #aaf? ,,congress #a/ ,session ,s4 #bhig ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,novemb] #ai1 #bjai,mr4 ,w>n] 7= himself1 ,mr4 ,cassidy1 ,mr4 ,van ,holl51 & ,mrs4 ,capito7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,f9ance ,a ,,bill ,to am5d title ,,xi ( ! ,social ,security ,act to reau?orize ! ,pati5t-,c5t]$ ,outcomes ,rese>* ,in/itute1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,pati5t-,c5t]$ ,outcomes ,rese>* ,in/itute ,reau?orization ,act4 #b4 ,reau?orization ( ,pati5t-,c5t]$ ,outcomes ,rese>* ,in/itute 7a7 ,ext5sion ( fund+ 7#a7 ,m&atory appropriations ,section #ieaa ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$-- 7,a7 9 subsection 7b77#a77;,e71 by /rik+ #bjad & all t foll[s ?r\gh #bjai & ins]t+ #bjad ?r\gh #bjbi2 7,b7 9 subsection 7d77#b77;,a71 by /rik+ #bjai & ins]t+ #bjbi2 & 7,c7 9 subsection 7f71 by /rik+ #bjai & ins]t+ #bjbi4 7#b7 ,ext5sion ( ,m$ic>e transf]s ,section #aahc7;a77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;e-#b7;a77#b77 is am5d$ by /rik+ #bjad & all t foll[s ?r\gh #bjai & ins]t+ #bjad ?r\gh #bjbi4 7#c7 ,ext5sion ( c]ta9 heal? insurance fees 7,a7 ,heal? insurance policies ,section #dcge7;e7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ #bjai & ins]t+ #bjbi4 7,b7 ,self-insur$ heal? plans ,section #dcgf7;e7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ #bjai & ins]t+ #bjbi4 7b7 ,bo>d composition ,subsection 7f7 ( section #aaha ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;e7 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,c7-- 7i7 9 ! matt] prec$+ clause 7i7-- 7,i7 by /rik+ ,sev5te5 & ins]t+ ,tw5ty-?ree2 & 7,,ii7 by /rik+ 1 n lat] ?an #f mon?s aft] ! date ( enactm5t ( ?is section12 & 7ii7 9 clause 7iii71 by /rik+ #c & ins]t+ #g2 & 7#b7 9 p>agraph 7#c7-- 7,a7 9 ! fir/ s5t5ce-- 7i7 by /rik+ ! ! memb]s & ins]t+ memb]s2 & 7ii7 by ins]t+ ! foll[+ be=e ! p]iod at ! end3 to ! ext5t necess>y to pres]ve ! ev5ly /agg]$ t]ms ( ! ,bo>d42 & 7,b7 by ins]t+ ! foll[+ aft] ! fir/ s5t5ce3 ,any memb] appo9t$ to fill a vacancy occurr+ be=e ! expiration ( ! t]m = :i* ! memb]'s pr$ecessor 0 appo9t$ %all be appo9t$ = ! rema9d] ( t t]m & !reaft] may be eligible = reappo9tm5t to a full t]m4 ,a memb] may s]ve aft] ! expiration ( t memb]'s t]m until a successor has be5 appo9t$44 7c7 ,consid]ation ( full range ( outcomes data ,subsection 7d77#b7 ( su* section #aaha is am5d$ by add+ at ! end ! foll[+ subp>agraph3 7,f7 ,consid]ation ( full range ( outcomes data ,rese>* %all be design$1 z appropriate1 to take into acc\nt & capture ! full range ( cl9ical & pati5t-c5t]$ outcomes relevant to1 & t meet ! ne$s (1 pati5ts1 cl9icians1 pur*as]s1 & policy mak]s 9 mak+ in=m$ heal? decisions4 ,9 addition to ! relative heal? outcomes & cl9ical effectiv5ess1 cl9ical & pati5t-c5t]$ outcomes %all include ! pot5tial burd5s & economic impacts ( ! utilization ( m$ical treatm5ts1 items1 & s]vices on diff]5t /akehold]s & decision mak]s respectively4 ,^! pot5tial burd5s & economic impacts include m$ical out-(-pocket co/s1 includ+ heal? plan b5efit & =mul>y design1 non-m$ical co/s to ! pati5t & family1 includ+ c>egiv+1 effects on future co/s ( c>e1 workplace productivity & abs5teeism1 & heal?c>e utilization4 4 7d7 ,e/abli%m5t ( exp]t advisory panel ,subsection 7d77#d77;,a7 ( su* section #aaha is am5d$ by add+ at ! end ! foll[+ new clause3 7iv7 ,exp]t advisory panel = high-impact rese>* ,! ,in/itute %all appo9t an exp]t advisory panel = purposes ( assi/+ & advis+ ! ,in/itute on ways to take into acc\nt & t>get diseases1 conditions1 & c>e int]v5tions t h a high-impact on national heal? exp5ditures & advance ! incorporation ( practical evid5ce into heal? c>e deliv]y 9 ! national priorities = rese>* & ! rese>* project ag5da "u p>agraph 7#a74 ,su* panel %all include memb]s repres5t+ private & public pay]s 9 addition to ! composition requirem5ts describ$ 9 subp>agraph 7,b74 4 7e7 ,ensur+ cov]age = cl9ical trials "u exi/+ /&>d ( c>e 7#a7 ,revision to def9ition ( approv$ cl9ical trial 9 individual & gr\p m>ket 7,a7 ,9 g5]al ,subsection 7d77#a7 ( ! fir/ section #bgji ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#h7 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,d7 ,! /udy or inve/igation is approv$ or fund$ 7:i* may include fund+ ?r\gh 9-k9d contributions7 by ! ,pati5t-,c5t]$ ,outcomes ,rese>* ,in/itute e/abli%$ "u section #aaha ( ! ,social ,security ,act4 4 7,b7 ,applicability date ,! am5dm5t made by ?is p>agraph %all apply ) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbj4 7#b7 ,m$ic>e cov]age ( r\t9e co/s associat$ ) c]ta9 cl9ical trials 7,a7 ,9 g5]al ,section #ahfb7m77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciey7m77#b77 is am5d$1 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ 7includ+ a trial fund$ by ! ,pati5t-,c5t]$ ,outcomes ,rese>* ,in/itute e/abli%$ "u section #aaha7 aft] means a trial4 7,b7 ,effective date ,! am5dm5t made by ?is subp>agraph %all apply ) respect to items & s]vices furni%$ on or aft] ! date ( ! enactm5t ( ?is ,act4 7f7 ,additions to annual reports by ! ,in/itute ,subsection 7d77#aj77;,a7 ( su* section #aaha is am5d$-- 7#a7 by ins]t+ 1 includ+ n>rative /atem5ts ( fund+ ann\ncem5ts ( ! ,in/itute1 aft] p>agraph 7#a77;,a72 & 7#b7 by ins]t+ ! foll[+ be=e ! semicolon3 z well z any b>ri]s t rese>*]s fund$ by ! ,in/itute h enc\nt]$ 9 conduct+ /udies or cl9ical trials1 includ+ *all5ges cov]+ ! co/ ( any m$ical treatm5ts1 s]vices1 & items describ$ 9 subsection 7a77#b77;,b7 = purposes ( ! rese>* /udy4 7g7 ,,gao ov]sight ,subsection 7g77#b77;,a7 ( su* section #aaha is am5d$ by add+ at ! end ! foll[+ new clause3 7vi7 ,n less frequ5tly ?an e #e ye>s1 any b>ri]s t rese>*]s fund$ by ! ,in/itute h enc\nt]$ 9 conduct+ /udies or cl9ical trials1 includ+ *all5ges cov]+ ! co/ ( any m$ical treatm5ts1 s]vices1 & items describ$ 9 subsection 7a77#b77;,b7 = purposes ( ! rese>* /udy4 4 7h7 ,ag5cy = ,heal?c>e ,rese>* & ,quality activities 7#a7 ,implem5tation ( rese>* f9d+s ,section #icg7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bii;b-#cg7;b77 is am5d$ to read z foll[s3 7b7 ,implem5tation ,! ,ag5cy = ,heal?c>e ,rese>* & ,quality1 9 consultation ) relevant m$ical & cl9ical associations1 %all c>ry out activities to promote ! timely implem5tation ( rese>* f9d+s dissem9at$ "u subsection 7a7 into cl9ical practices1 includ+ by assi/+ us]s ( heal? in=mation te*nology focus$ on cl9ical decision support 9 su* implem5tation1 9 ord] to improve quality ( c>e1 heal? outcomes1 & population heal? & to promote ! ease ( use ( su* implem5tation4 4 7#b7 ,pap]work ,r$uction ,act ,section #icg ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bii;b-#cg7 is am5d$ by add+ at ! end ! foll[+3 7h7 ,adm9i/ration ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to any activity c>ri$ out "u ?is section4 4 7#c7 ,(fice ( ,communication & ,k ,transf] 7,a7 ,9 g5]al ,section #icg ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bii;b-#cg71 z am5d$ by p>agraph 7#a71 is fur!r am5d$-- 7i7 9 subsection 7a77#a71 by /rik+ ,! ,(fice ( ,communication & ,k ,transf] & all t foll[s ?r\gh ,heal?c>e ,rese>* & ,quality7 & ins]t+ ,! ,ag5cy = ,heal?c>e ,rese>* & ,quality2 & 7ii7 by /rik+ ,(fice ea* place x appe>s & ins]t+ ,ag5cy = ,heal?c>e ,rese>* & ,quality4 7,b7 ,pati5t-,c5t]$ ,outcomes ,rese>* ,tru/ ,fund ,section #ieaa7;d77#b77;,c77i7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by /rik+ ! ,(fice ( ,communication & ,k ,transf] & all t foll[s ?r\gh ,heal?c>e ,rese>* & ,quality7 & ins]t+ ! ,ag5cy = ,heal?c>e ,rese>* & ,quality4 7i7 ,promotion ( timely implem5tation ( rese>* f9d+s ,subsection 7c7 ( su* section #aaha is am5d$ by ins]t+ & promotion ( ! timely implem5tation aft] dissem9ation4 7j7 ,id5tification ( rese>* priorities ,subsection 7d77#a77;,a7 ( su* section #aaha is am5d$ by add+ at ! end ! foll[+ new s5t5ce3 ,su* priorities %\ld reflect a balance betwe5 long-t]m priorities & %ort-t]m priorities1 & be responsive to *ang+ m$ical evid5ce & heal? c>e treatm5ts44 7k7 ,effective date ,except z o!rwise provid$ 9 ?is section1 ! provisions (1 & ! am5dm5ts made by1 ?is section %all take effect on ! date ( ! enactm5t ( ?is ,act4