,,ii #aaf? ,,congress #b;d ,session ,s4 #dgdb ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,septemb] #bi1 #bjbj,mr4 ,burr 7= himself & ,mr4 ,c>d97 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,f9ance ,a ,,bill ,to am5d title ,,xix ( ! ,social ,security ,act to promote access to life-sav+ !rapies = ,m$icaid enrollees by ensur+ cov]age ( r\t9e pati5t co/s = items & s]vices furni%$ 9 connection ) p>ticipation 9 qualify+ cl9ical trials1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,cov]+ ,life-sav+ ,inve/igations ,ne$$ ,9 ,canc] ,& o!r ,life-?reat5+ conditions ?r\gh ,timely use ( ,res\rces = ,easy & ,af=dable ,treatm5t f ,m$icaid = ,enrollees 9 ,ne$ ,today ,act or ! ,,cl9ical ,,treatm5t ,act4 #b4 ,promot+ access to life-sav+ !rapies = ,m$icaid enrollees by ensur+ cov]age ( r\t9e pati5t co/s = items & s]vices furni%$ 9 connection ) p>ticipation 9 qualify+ cl9ical trials 7a7 ,9 g5]al ,section #aije ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#bi71 by /rik+ & at ! end2 7,b7 by r$esignat+ p>agraph 7#cj7 z p>agraph 7#ca72 & 7,c7 by ins]t+ aft] p>agraph 7#bi7 ! foll[+ new p>agraph3 7#cj7 subject to subsection 7gg71 r\t9e pati5t co/s = items & s]vices furni%$ 9 connection ) p>ticipation 9 a qualify+ cl9ical trial 7z def9$ 9 su* subsection72 & 2 & 7#b7 by add+ at ! end ! foll[+ new subsection3 7gg7 7#a7 ,r\t9e pati5t co/s ,= purposes ( subsection 7a77#cj71 ) respect to a ,/ate & an individual enroll$ "u ! ,/ate plan 7or a waiv] ( su* plan7 :o p>ticipates 9 a qualify+ cl9ical trial1 r\t9e pati5t co/s-- 7,a7 include any item or s]vice provid$ to ! individual "u ! qualify+ cl9ical trial1 includ+ any item or s]vice provid$ to prev5t1 diagnose1 or treat complications result+ f su* p>ticipation1 to ! ext5t t ! provision ( su* an item or s]vice to ! individual outside ! c\rse ( su* p>ticipation w\ld o!rwise be cov]$ "u ! ,/ate plan or waiv]2 & 7,b7 does n include-- 7i7 ! inve/igational item or s]vice t is ! subject ( ! qualify+ cl9ical trial2 or 7ii7 an item or s]vice t is-- 7,i7 provid$ to ! individual solely to satisfy data collection & analysis ne$s = ! qualify+ cl9ical trial & is n us$ 9 ! direct cl9ical managem5t ( ! individual2 & 7,,ii7 n o!rwise cov]$ "u ! ,/ate plan or waiv]4 7#b7 ,qualify+ cl9ical trial def9$ 7,a7 ,9 g5]al ,= purposes ( ?is subsection & subsection 7a77#cj71 ! t]m qualify+ cl9ical trial means a cl9ical trial 79 any cl9ical phase ( developm5t7 t is conduct$ 9 relation to ! prev5tion1 detection1 or treatm5t ( any s]i\s or life-?reat5+ disease or condition & is describ$ 9 any ( ! foll[+ clauses3 7i7 ,! /udy or inve/igation is approv$ or fund$ 7:i* may include fund+ ?r\gh 9-k9d contributions7 by "o or m ( ! foll[+3 7,i7 ,! ,national ,in/itutes ( ,heal?4 7,,ii7 ,! ,c5t]s = ,disease ,control & ,prev5tion4 7,,iii7 ,! ,ag5cy = ,heal?c>e ,rese>* & ,quality4 7,,iv7 ,! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 7,v7 ,a coop]ative gr\p or c5t] ( any ( ! entities describ$ 9 subclauses 7,i7 ?r\gh 7,,iv7 or ! ,dep>tm5t ( ,def5se or ! ,dep>tm5t ( ,vet]ans ,affairs4 7,,vi7 ,a qualifi$ non-gov]nm5tal rese>* entity id5tifi$ 9 ! guidel9es issu$ by ! ,national ,in/itutes ( ,heal? = c5t] support grants4 7,,vii7 ,any ( ! foll[+ if ! conditions describ$ 9 subp>agraph 7,b7 are met3 7aa7 ,! ,dep>tm5t ( ,vet]ans ,affairs4 7bb7 ,! ,dep>tm5t ( ,def5se4 7cc7 ,! ,dep>tm5t ( ,en]gy4 7ii7 ,! cl9ical trial is conduct$ pursuant to an inve/igational new drug exemption "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i77 or an exemption = a biological product und]go+ inve/igation "u section #cea7;a77#c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a77#c774 7iii7 ,! cl9ical trial is a drug trial t is exempt f hav+ su* an inve/igational new drug application4 7,b7 ,conditions ,= purposes ( subp>agraph 7,a77i77,,vii71 ! conditions describ$ 9 ?is subp>agraph1 ) respect to a cl9ical trial approv$ or fund$ by an entity describ$ 9 su* subp>agraph 7,a77i77,,vii71 are t ! cl9ical trial has be5 review$ & approv$ ?r\gh a sy/em ( pe] review t ! ,secret>y det]m9es-- 7i7 to be comp>able to ! sy/em ( pe] review ( /udies & inve/igations us$ by ! ,national ,in/itutes ( ,heal?2 & 7ii7 assures unbias$ review ( ! highe/ sci5tific /&>ds by qualifi$ individuals ) no int]e/ 9 ! outcome ( ! review4 7#c7 ,cov]age det]m9ation requirem5ts ,a det]m9ation ) respect to cov]age "u subsection 7a77#cj7 = an individual p>ticipat+ 9 a qualify+ cl9ical trial-- 7,a7 %all be exp$it$ & complet$ )9 #bd h\rs2 7,b7 %all be made )\t limitation on ! geographic location or network affiliation ( ! heal? c>e provid] treat+ su* individual or ! pr9cipal inve/igator ( ! qualify+ cl9ical trial2 7,c7 %all be bas$ on atte/ation reg>d+ ! appropriat5ess ( ! qualify+ cl9ical trial by ! heal? c>e provid] & pr9cipal inve/igator describ$ 9 subp>agraph 7,b71 :i* %all be made us+ a /reaml9$1 uni=m =m develop$ = national use by ! ,secret>y & t includes ! option to ref]5ce in=mation reg>d+ ! qualify+ cl9ical trial t is publicly available on a website ma9ta9$ by ! ,secret>y1 su* z cl9icaltrials4gov 7or a successor website72 & 7,d7 %all n require submission ( ! protocols ( ! qualify+ cl9ical trial1 or any o!r docum5tation t may be propriet>y or det]m9$ by ! ,secret>y to be burd5some to provide4 4 7b7 ,requir+ m&atory cov]age "u ,/ate plan ,section #aijb7;a77#aj77;,a7 ( su* ,act is am5d$1 9 ! matt] prec$+ clause 7i71 by /rik+ & 7#bi7 & ins]t+ 7#bi71 & 7#cj74 7c7 ,inclusion 9 b5*m>k cov]age ,section #aicg7;b77#e7 ( su* ,act is am5d$ by ins]t+ be=e ! p]iod at ! end ! foll[+3 1 & beg9n+ ,janu>y #a1 #bjbj1 cov]age ( r\t9e pati5t co/s = items & s]vices furni%$ 9 connection ) p>ticipation 9 a qualify+ cl9ical trial 7z def9$ 9 section #aije7;gg774 7d7 ,effective date 7#a7 ,9 g5]al ,! am5dm5ts made by ?is section %all apply ) respect to items & s]vices furni%$ on or aft] ! date ( ! enactm5t ( ?is ,act4 7#b7 ,exception = ,/ate legislation ,9 ! case ( a ,/ate plan "u title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 t ! ,secret>y ( ,heal? & ,human ,s]vices det]m9es requires ,/ate legislation 9 ord] = ! respective plan to meet any requirem5t impos$ by am5dm5ts made by ?is section1 ! respective plan %all n be reg>d$ z fail+ to comply ) ! requirem5ts ( su* title solely on ! basis ( its failure to meet su* an additional requirem5t 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> ( ! session %all be consid]$ to be a sep>ate regul> session ( ! ,/ate legislature4