,,ii #aai? ,,congress #b;d ,session ,s4 #dbbj ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,m>* #bf1 #bjbf,mr4 ,%eehy 7= himself1 ,mr4 ,gallego1 ,ms4 ,duckwor?1 & ,mr4 ,boozman7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,vet]ans' ,affairs ,a ,,bill ,to am5d title #ch1 ,unit$ ,/ates ,code1 to e/abli% )9 ! ,vet]ans ,heal? ,adm9i/ration an ,(fice ( ,novel ,!rapeutics1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,vet]ans ,heal? ,adm9i/ration ,novel ,!rapeutics ,prep>$ness ,act4 #b4 ,f9d+s ,congress f9ds ! foll[+3 7#a7 ,em]g+ !rapeutic int]v5tions1 includ+ c]ta9 psy*$elic-assi/$ !rapies "u evaluation by ! ,food & ,drug ,adm9i/ration z ( ! date ( ! enactm5t ( ?is ,act1 may significantly alt] ! treatm5t l&scape = po/-traumatic /ress disord]1 depression1 & o!r m5tal heal? conditions affect+ vet]ans4 7#b7 ,! adm9i/ration ( c]ta9 em]g+ !rapies may require int5sive cl9ical engagem5t1 int]discipl9>y teams1 d$icat$ cl9ical space1 /ructur$ prep>ation1 & po/-treatm5t integration t diff] sub/antially f traditional outpati5t m5tal heal? s]vices4 7#c7 ,! ,dep>tm5t ( ,vet]ans ,affairs is uniquely position$ to deliv] integrat$1 vet]an-c5t]$ c>e t comb9es m$ical1 m5tal heal?1 & pe] support s]vices )9 a s+le sy/em ( c>e4 7#d7 ,abs5t c5traliz$ gov]nance & implem5tation plann+1 ! ,dep>tm5t may face delays1 safety risks1 or inconsi/5t access foll[+ regulatory approval ( su* !rapies4 7#e7 ,e/abli%+ a d$icat$ ,(fice ( ,novel ,!rapeutics w ensure t ! ,dep>tm5t is prep>$ to responsibly evaluate1 rese>*1 & implem5t em]g+ treatm5t modalities consi/5t ) pati5t safety & evid5ce-bas$ practice4 #c4 ,e/abli%m5t ( ,(fice ( ,novel ,!rapeutics )9 ,vet]ans ,heal? ,adm9i/ration 7a7 ,e/abli%m5t 7#a7 ,9 g5]al ,*apt] #gc ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by add+ at ! end ! foll[+ new sub*apt]3 ,,vi ,novel ,!rapeutics #gcia4 ,def9itions ,9 ?is sub*apt]3 7#a7 ,c5t] ( excell5ce ,! t]m c5t] ( excell5ce means a m$ical c5t] ( ! ,dep>tm5t designat$ "u section #gcid ( ?is title z a c5t] ( excell5ce = novel !rapeutics to advance rese>*1 tra9+1 & implem5tation ( em]g+ !rapeutic int]v5tions4 7#b7 ,em]g+ !rapeutic int]v5tion ,! t]m em]g+ !rapeutic int]v5tion means a ph>macological1 biological1 or o!r !rapeutic modality "u evaluation or review by ! ,food & ,drug ,adm9i/ration4 #gcib4 ,(fice ( ,novel ,!rapeutics 7a7 ,e/abli%m5t ,!re is e/abli%$ )9 ! ,vet]ans ,heal? ,adm9i/ration1 "u ! ,(fice ( ! ,"u ,secret>y = ,heal?1 an ,(fice ( ,novel ,!rapeutics 79 ?is section ref]r$ to z ! ,(fice74 7b7 ,director ,! head ( ! ,(fice %all be ! ,director ( ! ,(fice ( ,novel ,!rapeutics1 :o %all be appo9t$ by ! ,"u ,secret>y = ,heal? & :o %all-- 7#a7 possess demon/rat$ exp]tise 9 cl9ical rese>* & implem5tation sci5ce2 & 7#b7 report directly to ! ,"u ,secret>y = ,heal?4 7c7 ,coord9at+ au?ority ,! ,(fice %all s]ve z ! prim>y coord9at+ au?ority )9 ! ,vet]ans ,heal? ,adm9i/ration = matt]s relat+ to em]g+ & novel !rapeutic int]v5tions4 7d7 ,duties ,! ,(fice %all-- 7#a7 develop & ov]see national policy1 guidance1 & cl9ical /&>ds = ! evaluation1 rese>*1 & pot5tial implem5tation by ! ,vet]ans ,heal? ,adm9i/ration ( em]g+ & novel !rapeutic int]v5tions = m5tal heal? conditions affect+ vet]ans2 7#b7 develop a national cl9ical model = ! adm9i/ration ( int5sive !rapeutic int]v5tions1 includ+ /ructur$ prep>ation1 monitor$ adm9i/ration1 & po/-adm9i/ration integration2 7#c7 develop guidance reg>d+ pati5t eligibility & c&idacy = em]g+ !rapeutic int]v5tions1 ensur+ t utilization managem5t or /ep !rapy requirem5ts d n unduly re/rict access :]e cl9ically appropriate2 7#d7 develop implem5tation-read9ess plans = !rapies t may receive approval f ! ,food & ,drug ,adm9i/ration1 includ+-- 7,a7 facility infra/ructure requirem5ts2 7,b7 int]discipl9>y team composition /&>ds2 7,c7 allocation ( protect$ cl9ical "t necess>y to safely adm9i/] int5sive !rapeutic int]v5tions1 includ+ full session & integration requirem5ts2 7,d7 pati5t safety & adv]se ev5t monitor+ & response protocols2 & 7,e7 integration ) suicide prev5tion1 po/-traumatic /ress disord]1 & sub/ance use disord] programs2 7#e7 conduct a work=ce-read9ess assessm5t to id5tify cl9icians & pe] support speciali/s ) prior tra9+ or c]tification relevant to em]g+ !rapeutic int]v5tions & gaps 9 tra9+1 sup]vision1 & cl9ical capacity necess>y to support safe & effective implem5tation ( su* int]v5tions2 7#f7 e/abli% national tra9+ & cr$5tial+ /&>ds = cl9icians adm9i/]+ novel !rapeutics2 7#g7 develop a /&>diz$1 compet5cy-bas$ tra9+ framework = cl9icians & pe] support speciali/s p>ticipat+ 9 em]g+ !rapeutic int]v5tions1 includ+ prep>ation1 monitor$ adm9i/ration1 integration1 safety monitor+1 int]discipl9>y collaboration1 & culturally compet5t c>e2 7#h7 di/+ui% betwe5 rese>* protocols & cl9ical implem5tation /&>ds to ensure t pati5t c>e models are n con/ra9$ solely by sponsor-driv5 rese>* design2 7#i7 coord9ate ) ! ,(fice ( ,rese>* & ,developm5t-- 7,a7 to align rese>* priorities ) implem5tation-read9ess ne$s2 7,b7 to recomm5d specializ$ review pa?ways = rese>* involv+ em]g+ !rapeutic int]v5tions2 & 7,c7 to develop /&>ds = allocation ( protect$ rese>* "t = cl9icians p>ticipat+ 9 rese>* involv+ em]g+ !rapeutic int]v5tions1 includ+ cl>ification t pati5ts se5 "u approv$ rese>* protocols %all be c\nt$ t[>d /&>d cl9ical productivity metrics2 7#aj7 develop guidance to ensure cont9uity ( c>e1 includ+-- 7,a7 po/-adm9i/ration integration s]vices2 7,b7 incorporation ( pe] support speciali/s2 & 7,c7 coord9ation ) community-bas$ organizations = aft]c>e support z appropriate2 7#aa7 id5tify n few] ?an "o m$ical c5t] 9 ea* ,vet]ans ,integrat$ ,s]vice ,network to develop infra/ructure & work=ce-read9ess = em]g+ !rapeutic models2 & 7#ab7 e/abli% crit]ia = ! designation ( c5t]s ( excell5ce & ov]see compliance ) national /&>ds4 #gcic4 ,cl9ical ,implem5tation ,program = ,em]g+ ,!rapeutics 7a7 ,e/abli%m5t ,! ,secret>y1 act+ ?r\gh ! ,(fice ( ,novel ,!rapeutics1 %all e/abli% a ,cl9ical ,implem5tation ,program = ,em]g+ ,!rapeutics 79 ?is section ref]r$ to z ! ,program7 to evaluate ! effectiv5ess1 feasibility1 safety1 & scalability ( em]g+ !rapeutic int]v5tions )9 ! ,dep>tm5t4 7b7 ,purpose ,! ,program %all-- 7#a7 utilize effectiv5ess-implem5tation hybrid models to evaluate bo? cl9ical outcomes & real-_w implem5tation factors ) respect to em]g+ !rapeutic int]v5tions2 7#b7 te/ & ref9e c>e deliv]y models1 includ+ pati5t eligibility crit]ia1 safety protocols1 int]discipl9>y team models1 & po/-adm9i/ration integration s]vices2 7#c7 g5]ate real-_w evid5ce to in=m pot5tial sy/emwide adoption2 & 7#d7 assess work=ce1 infra/ructure1 co/1 & op]ational requirem5ts necess>y = broad] implem5tation4 7c7 ,cov]$ conditions ,9 c>ry+ out ! ,program1 ! ,secret>y may prioritize "o or m bra9 or m5tal heal? conditions affect+ vet]ans1 includ+-- 7#a7 po/-traumatic /ress disord]2 7#b7 treatm5t-resi/ant depression2 7#c7 sub/ance use disord]s2 7#d7 suicidality2 7#e7 traumatic bra9 injury2 7#f7 repetitive l[-level bla/ exposure2 7#g7 *ronic pa92 7#h7 co-occurr+ conditions2 & 7#i7 o!r cl9ically appropriate conditions z det]m9$ appropriate by ! ,secret>y4 7d7 ,site selection ,! ,secret>y may conduct ! ,program at-- 7#a7 "o or m c5t]s ( excell5ce2 & 7#b7 su* o!r m$ical c5t]s z ! ,secret>y det]m9es appropriate4 #gcid4 ,c5t]s ( excell5ce = novel !rapeutics 7a7 ,designation ,! ,secret>y may designate "o or m m$ical c5t]s ( ! ,dep>tm5t z c5t]s ( excell5ce = novel !rapeutics4 7b7 ,functions ,ea* c5t] ( excell5ce designat$ "u subsection 7a7 %all-- 7#a7 s]ve z a national lead] 9 rese>*1 cl9ical tra9+1 & implem5tation ( em]g+ !rapeutic int]v5tions2 7#b7 develop & dissem9ate be/ practices & cl9ical /&>ds across ! ,vet]ans ,heal? ,adm9i/ration2 7#c7 provide te*nical assi/ance & tra9+ to o!r m$ical c5t]s ( ! ,dep>tm5t2 7#d7 integrate int]discipl9>y c>e models1 includ+ pe] support & po/-adm9i/ration integration s]vices2 7#e7 incorporate vet]an advisory input into program developm5t2 & 7#f7 coord9ate ) academic affiliates & ext]nal rese>* p>tn]s1 z appropriate4 7c7 ,coord9ation ,c5t]s ( excell5ce designat$ "u subsection 7a7 %all op]ate 9 coord9ation )1 & "u /&>ds e/abli%$ by1 ! ,(fice ( ,novel ,!rapeutics4 #gcie4 ,vet]an ,advisory ,committee on ,novel ,!rapeutics 7a7 ,e/abli%m5t ,! ,secret>y %all e/abli% a ,vet]an ,advisory ,committee on ,novel ,!rapeutics 79 ?is section ref]r$ to z ! ,committee7 to advise ! ,(fice ( ,novel ,!rapeutics4 7b7 ,memb]%ip ,! ,secret>y %all select ! memb]s ( ! ,committee1 :i* %all include ! foll[+3 7#a7 ,vet]ans ) liv$ exp]i5ce ( m5tal heal? treatm5t furni%$ by ! ,dep>tm5t4 7#b7 ,vet]ans :o h p>ticipat$ 9 cl9ical rese>* involv+ em]g+ !rapeutic int]v5tions1 z applicable4 7#c7 ,family memb]s or c>egiv]s ( vet]ans describ$ 9 p>agraph 7#a7 or 7#b74 7#d7 ,repres5tatives f academic in/itutions affiliat$ ) ! ,dep>tm5t ) exp]tise 9 cl9ical rese>*1 behavioral heal?1 or em]g+ !rapeutic int]v5tions4 7#e7 ,subject matt] exp]ts z det]m9$ appropriate by ! ,secret>y4 7c7 ,duties ,) respect to ! use ( novel !rapeutics1 ! ,committee %all provide input on-- 7#a7 pati5t safety consid]ations2 7#b7 in=m$ cons5t practices2 7#c7 implem5tation & access b>ri]s2 & 7#d7 pati5t-c5t]$ c>e design4 #gcif4 ,int]ag5cy coord9ation ,9 c>ry+ out ?is sub*apt]1 ! ,secret>y %all coord9ate ) ! ,secret>y ( ,heal? & ,human ,s]vices1 ! ,commission] ( ,food & ,drugs1 ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 ! ,secret>y ( ,def5se1 & ! ,adm9i/rator ( ! ,drug ,en=cem5t ,adm9i/ration to support-- 7#a7 regulatory read9ess2 7#b7 developm5t ( reimbursem5t & bill+ pa?ways2 7#c7 s*$ul+ & res*$ul+ consid]ations1 z appropriate2 & 7#d7 %>$ data infra/ructure = monitor+ safety1 quality1 & outcomes4 #gcig4 ,annual report ,n less frequ5tly ?an annually1 ! ,secret>y %all submit to ,congress a report describ+-- 7#a7 rese>* activities ( ! ,dep>tm5t relat+ to em]g+ !rapeutic int]v5tions2 7#b7 cl9ical outcomes & pati5t-report$ outcomes "u ! ,cl9ical ,implem5tation ,program = ,em]g+ ,!rapeutics "u section #gcic ( ?is title2 7#c7 safety ev5ts & adv]se outcomes2 7#d7 work=ce read9ess & tra9+ capacity2 7#e7 implem5tation b>ri]s1 includ+ /aff+1 procurem5t1 & infra/ructure ne$s2 & 7#f7 recomm5dations = legislative or adm9i/rative action relat+ to novel !rapeutics4 4 7#b7 ,cl]ical am5dm5t ,! table ( sections at ! beg9n+ ( *apt] #gc ( su* title is am5d$ by add+ at ! end ! foll[+3 ,,sub*apt] ,,vi--,novel ,therapeutics,sec4#gcia4 ,def9itions4#gcib4 ,(fice ( ,novel ,!rapeutics4#gcic4 ,cl9ical ,implem5tation ,program = ,em]g+ ,!rapeutics4#gcid4 ,c5t]s ( excell5ce = novel !rapeutics4#gcie4 ,vet]an ,advisory ,committee on ,novel ,!rapeutics4#gcif4 ,int]ag5cy coord9ation4#gcig4 ,annual report4 4 7b7 ,national prep>$ness & implem5tation /rategy ,n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,vet]ans ,affairs %all submit to ,congress a national prep>$ness & implem5tation /rategy ( ! ,vet]ans ,heal? ,adm9i/ration = em]g+ m5tal heal? !rapeutics1 includ+-- 7#a7 work=ce capacity assessm5ts2 7#b7 facility modification ne$s2 7#c7 project$ timel9es = phas$ implem5tation2 & 7#d7 b>ri]s to implem5tation4