,i #aaf? ,,congress #b;d ,session ,h4 ,r4 #ijjf ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,decemb] #ag1 #bjbj ,mr4 ,g>ca ( ,ill9ois introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d title ,,xix ( ! ,social ,security ,act to provide = cov]age "u ! ,m$icaid program "u su* title ( r\t9e pati5t co/s associat$ ) p>ticipation 9 c]ta9 cl9ical trials1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,inclusive ,cl9ical ,trials ,act4 #b4 ,p>ticipation by ,m$icaid b5efici>ies 9 approv$ cl9ical trials 7a7 ,9 g5]al ,title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 is am5d$ by add+ at ! end ! foll[+ new section3 #aidg4 ,p>ticipation 9 an approv$ cl9ical trial 7a7 ,cov]age ( r\t9e pati5t co/s associat$ ) approv$ cl9ical trials 7#a7 ,inclusion ,subject to p>agraph 7#b71 r\t9e pati5t co/s %all include all items & s]vices consi/5t ) ! m$ical assi/ance provid$ "u ! ,/ate plan t w\ld o!rwise be provid$ to ! individual "u su* ,/ate plan if su* individual 0 n enroll$ 9 an approv$ cl9ical trial1 includ+ any items or s]vices relat$ to ! prev5tion1 detection1 & treatm5t ( any m$ical complications t arise z a result ( p>ticipation 9 ! approv$ cl9ical trial4 7#b7 ,exclusion ,= purposes ( p>agraph 7#a71 r\t9e pati5t co/s does n include-- 7,a7 ! inve/igational item1 device1 or s]vice itself2 7,b7 items & s]vices t are provid$ solely to satisfy data collection & analysis ne$s & t are n us$ 9 ! direct cl9ical managem5t ( ! pati5t2 or 7,c7 a s]vice t is cle>ly inconsi/5t ) widely accept$ & e/abli%$ /&>ds ( c>e = a p>ticul> diagnosis4 7#c7 ,in=mation conc]n+ cl9ical trials 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 ! ,secret>y1 9 consultation ) relevant /akehold]s1 %all develop a s+le /&>diz$ electronic =m = use by ! individual or ! ref]r+ heal? c>e provid] to submit to ! ,/ate ag5cy adm9i/]+ ! ,/ate plan 9 ord] to v]ify t ! cl9ical trial meets ! conditions e/abli%$ = an approv$ cl9ical trial 7z def9$ 9 subsection 7c774 7,b7 ,exclud$ in=mation ,= purposes ( subp>agraph 7,a7 or any su* reque/ by ! ,/ate ag5cy = in=mation reg>d+ a cl9ical trial1 an individual or ref]r+ heal? c>e provid] %all n be requir$ to submit-- 7i7 ! cl9ical protocol docum5t = ! cl9ical trial2 or 7ii7 subject to subp>agraph 7,c71 any additional in=mation o!r ?an su* in=mation z is requir$ pursuant to ! =m describ$ 9 subp>agraph 7,a74 7,c7 ,optional in=mation ,= purposes ( subp>agraphs 7,a7 & 7,b77ii71 ! =m may include a requirem5t t ! ref]r+ heal? c>e provid] atte/ t ! individual is eligible to p>ticipate 9 ! cl9ical trial pursuant to ! trial protocol & t individual p>ticipation 9 su* trial w\ld be appropriate4 7,d7 ,review ( in=mation 7i7 ,9 g5]al ,a ,/ate plan "u ?is title %all e/abli% a process = timely review by ! ,/ate ag5cy ( ! =m & in=mation submitt$ pursuant to subp>agraph 7,a7 &1 n lat] ?an #dh h\rs aft] receipt ( su* =m1 confirmation t ! in=mation provid$ 9 su* =m satisfies ! requirem5ts e/abli%$ "u su* subp>agraph1 ) su* process to include e/abli%m5t & op]ation ( a #bd-;h\r1 toll-free telephone numb] & email address to provide = exp$it$ communication4 7ii7 ,failure to respond ,if an individual or ! ref]r+ heal? c>e provid] does n receive a response or reque/ = additional in=mation f ! ,/ate ag5cy foll[+ ! #dh-;h\r p]iod describ$ 9 clause 7i71 ! in=mation provid$ 9 ! =m may be presum$ to satisfy ! requirem5ts e/abli%$ "u ?is p>agraph4 7b7 ,enc\ragem5t ( p>ticipation 9 approv$ cl9ical trials 7#a7 ,reasonably accessible provid] ,= purposes ( p>ticipation 9 an approv$ cl9ical trial by an individual eligible = m$ical assi/ance "u ?is title1 ! ,/ate ag5cy adm9i/]+ ! ,/ate plan %all make reasonable ef=ts to ensure t ! individual is provid$ ) access to a provid] :o is-- 7,a7 p>ticipat+ 9 ! approv$ cl9ical trial2 7,b7 locat$ n m ?an #be miles f ! resid5ce ( ! individual 7or1 if no su* provid] is available1 z close z possible to ! resid5ce ( ! individual72 & 7,c7 a p>ticipat+ provid] "u ! ,/ate plan or has be5 deem$ to be a p>ticipat+ provid] "u ! ,/ate plan = purposes ( provid+ m$ical assi/ance to ! individual dur+ _! p>ticipation 9 ! approv$ cl9ical trial4 7#b7 ,in=mational mat]ials ,! ,/ate ag5cy adm9i/]+ ! plan approv$ "u ?is title %all develop in=mational mat]ials & programs to enc\rage p>ticipat+ provid]s to make appropriate ref]rals to physicians & o!r appropriate heal? c>e pr(essionals :o c provide individuals ) access to approv$ cl9ical trials4 7c7 ,def9ition ( approv$ cl9ical trial ,! t]m approv$ cl9ical trial has ! same mean+ z provid$ "u subsection 7d7 ( section #bgji ( ! ,public ,heal? ,s]vice ,act t relates to cov]age = individuals p>ticipat+ 9 approv$ cl9ical trials4 4 7b7 ,con=m+ am5dm5t ,section #aijb7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77 is am5d$-- 7#a7 by /rik+ & at ! end ( p>agraph 7#hd72 7#b7 by /rik+ ! p]iod at ! end ( p>agraph 7#he7 & ins]t+ 2 &2 & 7#c7 by ins]t+ aft] p>agraph 7#he7 ! foll[+ new p>agraph3 7#hf7 provide t p>ticipation 9 an approv$ cl9ical trial & cov]age ( r\t9e pati5t co/s associat$ ) su* trial = an individual eligible = m$ical assi/ance "u ?is title is conduct$ 9 accordance ) ! requirem5ts "u section #aidg4 4 7c7 ,effective date 7#a7 ,9 g5]al ,except z provid$ 9 p>agraph 7#b71 ! am5dm5ts made by ?is section %all apply to cal5d> qu>t]s beg9n+ on or aft] ,octob] #a1 #bjbj4 7#b7 ,delay p]mitt$ = ,/ate plan am5dm5t ,9 ! case ( a ,/ate plan = m$ical assi/ance "u title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 :i* ! ,secret>y ( ,heal? & ,human ,s]vices det]m9es requires ,/ate legislation 7o!r ?an legislation appropriat+ funds7 9 ord] = ! plan to meet ! additional requirem5ts impos$ by ! am5dm5ts made by ?is section1 ! ,/ate plan %all n be reg>d$ z fail+ to comply ) ! requirem5ts ( su* title solely on ! basis ( its failure to meet ^! additional requirem5ts be=e ! fir/ day ( ! fir/ cal5d> qu>t] beg9n+ aft] ! close ( ! fir/ regul> session ( ! ,/ate legislature t beg9s aft] ! date ( enactm5t ( ?is ,act4 ,= purposes ( ! previ\s s5t5ce1 9 ! case ( a ,/ate t has a #b-ye> legislative session1 ea* ye> ( su* session %all be deem$ to be a sep>ate regul> session ( ! ,/ate legislature4