,,ii ,cal5d> ,no4 #dhe #aae? ,,congress #b;d ,session ,h4 ,r4 #f ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,june #be1 #bjah,receiv$2 read ! fir/ "t ,june #bf1 #bjah,read ! second "t & plac$ on ! cal5d> ,,an ,,act ,to provide = opioid use disord] prev5tion1 recov]y1 & treatm5t1 & = o!r purposes4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,sub/ance ,use-,disord] ,prev5tion t ,promotes ,opioid ,recov]y & ,treatm5t = ,pati5ts & ,communities ,act or ! ,,support = ,pati5ts & ,communities ,act4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4 ,title ,i--,m$icaid ,provisions to ,address ! ,opioid ,crisis ,sec4 #ajja4 ,at-risk y\? ,m$icaid protection4 ,sec4 #ajjb4 ,heal? ,insurance = ,=m] ,fo/] ,y\?4 ,sec4 #ajjc4 ,demon/ration project to increase sub/ance use provid] capacity "u ! ,m$icaid program4 ,sec4 #ajjd4 ,drug managem5t program = at-risk b5efici>ies4 ,sec4 #ajje4 ,m$icaid drug review & utilization4 ,sec4 #ajjf4 ,guidance to improve c>e = infants ) neonatal ab/95ce syndrome & _! mo!rs2 ,,gao /udy on gaps 9 ,m$icaid cov]age = pregnant & po/p>tum wom5 ) sub/ance use disord]4 ,sec4 #ajjg4 ,m$icaid heal? homes = opioid-use-disord] ,m$icaid enrollees4 ,title ,,ii--,m$ic>e ,provisions to ,address ! ,opioid ,crisis ,sec4 #bjja4 ,au?ority n to apply c]ta9 ,m$ic>e teleheal? requirem5ts 9 ! case ( c]ta9 treatm5t ( a sub/ance use disord] or co-occurr+ m5tal heal? disord]4 ,sec4 #bjjb4 ,enc\rag+ ! use ( non-opioid analgesics = ! managem5t ( po/-surgical pa94 ,sec4 #bjjc4 ,requir+ a review ( curr5t opioid prescriptions = *ronic pa9 & scre5+ = opioid use disord] to be includ$ 9 ! ,welcome to ,m$ic>e initial prev5tive physical exam9ation4 ,sec4 #bjjd4 ,modification ( paym5t = c]ta9 outpati5t surgical s]vices4 ,sec4 #bjje4 ,requir+ e-prescrib+ = cov]age ( cov]$ "p ,d controll$ sub/ances4 ,sec4 #bjjf4 ,requir+ prescription drug plan sponsors "u ,m$ic>e to e/abli% drug managem5t programs = at-risk b5efici>ies4 ,sec4 #bjjg4 ,m$ic>e cov]age ( c]ta9 s]vices furni%$ by opioid treatm5t programs4 ,title ,,iii--,o!r ,heal? ,provisions to ,address ! ,opioid ,crisis ,sec4 #cjja4 ,cl>ify+ ,,fda regulation ( non-addictive pa9 & addiction !rapies4 ,sec4 #cjjb4 ,surveillance & ,te/+ ( ,opioids to ,prev5t ,f5tanyl ,dea?s4 ,sec4 #cjjc4 ,all[+ = m flexibility ) respect to m$ication-assi/$ treatm5t = opioid use disord]s4 ,sec4 #cjjd4 ,high-quality1 evid5ce-bas$ opioid analgesic prescrib+ guidel9es & report4 ,sec4 #cjje4 ,report on opioids prescrib+ practices = pregnant wom54 ,sec4 #cjjf4 ,guidel9es = prescrib+ naloxone4 ,sec4 #cjjg4 ,requir+ a survey ( sub/ance use disord] treatm5t provid]s receiv+ ,f$]al fund+4 ,title ,,iv--,(fsets ,sec4 #djja4 ,promot+ value 9 ,m$icaid manag$ c>e4 ,sec4 #djjb4 ,ext5d+ p]iod ( application ( ,m$ic>e second>y pay] rules = individuals ) end /age r5al disease4 ,sec4 #djjc4 ,requir+ report+ by gr\p heal? plans ( prescription drug cov]age in=mation = purposes ( id5tify+ prim>y pay] situations "u ! ,m$ic>e program4 ,title ,v--,o!r ,m$icaid ,provisions ,subtitle ,a--,m&atory report+ ) respect to adult behavioral heal? measures ,sec4 #ejja4 ,m&atory report+ ) respect to adult behavioral heal? measures4 ,subtitle ,b--,m$icaid ,,imd ,additional ,info ,sec4 #ejaa4 ,%ort title4 ,sec4 #ejab4 ,,macpac exploratory /udy & report on in/itutions = m5tal diseases requirem5ts & practices "u ,m$icaid4 ,subtitle ,c--,,*ip ,m5tal ,heal? ,p>ity ,sec4 #ejba4 ,%ort title4 ,sec4 #ejbb4 ,ensur+ access to m5tal heal? & sub/ance use disord] s]vices = *ildr5 & pregnant wom5 "u ! ,*ildr5's ,heal? ,insurance ,program4 ,subtitle ,d--,m$icaid ,re5try ,sec4 #ejca4 ,%ort title4 ,sec4 #ejcb4 ,promot+ ,/ate innovations to ease transitions integration to ! community = c]ta9 individuals4 ,subtitle ,e--,m$icaid ,p>tn]%ip ,sec4 #ejda4 ,%ort title4 ,sec4 #ejdb4 ,m$icaid provid]s are requir$ to note exp]i5ces 9 record sy/ems to help 9-ne$ pati5ts4 ,title ,,vi--,o!r ,m$ic>e ,provisions ,subtitle ,a--,te/+ ( inc5tive paym5ts = behavioral heal? provid]s = adoption & use ( c]tifi$ electronic heal? record te*nology ,sec4 #fjja4 ,te/+ ( inc5tive paym5ts = behavioral heal? provid]s = adoption & use ( c]tifi$ electronic heal? record te*nology4 ,subtitle ,b--,abuse ,det]r5t ,access ,sec4 #fjaa4 ,%ort title4 ,sec4 #fjab4 ,/udy on abuse-det]r5t opioid =mulations access b>ri]s "u ,m$ic>e4 ,subtitle ,c--,m$ic>e ,opioid ,safety ,education ,sec4 #fjba4 ,%ort title4 ,sec4 #fjbb4 ,provision ( in=mation reg>d+ opioid use & pa9 managem5t z "p ( ,m$ic>e ,y h&book4 ,subtitle ,d--,opioid ,addiction ,action ,plan ,sec4 #fjca4 ,%ort title4 ,sec4 #fjcb4 ,action plan on recomm5dations = *anges "u ,m$ic>e & ,m$icaid to prev5t opioids addictions & enhance access to m$ication-assi/$ treatm5t4 ,subtitle ,e--,advanc+ ,high ,quality ,treatm5t = ,opioid ,use ,disord]s 9 ,m$ic>e ,sec4 #fjda4 ,%ort title4 ,sec4 #fjdb4 ,opioid use disord] treatm5t demon/ration program4 ,subtitle ,f--,responsible ,education ,a*ieves ,c>e & ,heal?y ,outcomes = ,us]s' ,treatm5t ,sec4 #fjea4 ,%ort title4 ,sec4 #fjeb4 ,grants to provide te*nical assi/ance to outli] prescrib]s ( opioids4 ,subtitle ,g--,prev5t+ ,addiction = ,susceptible ,s5iors ,sec4 #fjfa4 ,%ort title4 ,sec4 #fjfb4 ,electronic prior au?orization = cov]$ "p ,d drugs4 ,sec4 #fjfc4 ,program integrity transp>5cy measures "u ,m$ic>e p>ts ,c & ,d4 ,sec4 #fjfd4 ,exp&+ eligibility = m$ication !rapy managem5t programs "u "p ,d4 ,sec4 #fjfe4 ,m$ic>e notifications to outli] prescrib]s ( opioids4 ,sec4 #fjff4 ,no additional funds au?oriz$4 ,subtitle ,h--,exp&+ ,ov]sight ( ,opioid ,prescrib+ & ,paym5t ,sec4 #fjga4 ,%ort title4 ,sec4 #fjgb4 ,m$ic>e ,paym5t ,advisory ,commission report on opioid paym5t1 adv]se inc5tives1 & data "u ! ,m$ic>e program4 ,sec4 #fjgc4 ,no additional funds au?oriz$4 ,subtitle ,i--,dr4 ,todd ,graham ,pa9 ,managem5t1 ,treatm5t1 & ,recov]y ,sec4 #fjha4 ,%ort title4 ,sec4 #fjhb4 ,review & adju/m5t ( paym5ts "u ! ,m$ic>e outpati5t prospective paym5t sy/em to avoid f9ancial inc5tives to use opioids in/ead ( non-opioid alt]native treatm5ts4 ,sec4 #fjhc4 ,exp&+ access "u ! ,m$ic>e program to addiction treatm5t 9 ,f$]ally qualifi$ heal? c5t]s & rural heal? cl9ics4 ,sec4 #fjhd4 ,/udy+ ! availability ( supplem5tal b5efits design$ to treat or prev5t sub/ance use disord]s "u ,m$ic>e ,advantage plans4 ,sec4 #fjhe4 ,cl9ical psy*ologi/ s]vices models "u ! ,c5t] = ,m$ic>e & ,m$icaid ,innovation2 ,,gao /udy & report4 ,sec4 #fjhf4 ,pa9 managem5t /udy4 ,subtitle ,j--,combat+ ,opioid ,abuse = ,c>e 9 ,hospitals ,sec4 #fjia4 ,%ort title4 ,sec4 #fjib4 ,develop+ guidance on pa9 managem5t & opioid use disord] prev5tion = hospitals receiv+ paym5t "u "p ,a ( ! ,m$ic>e program4 ,sec4 #fjic4 ,requir+ ! review ( quality measures relat+ to opioids & opioid use disord] treatm5ts furni%$ "u ! m$ic>e program & o!r f$]al heal? c>e programs4 ,sec4 #fjid4 ,te*nical exp]t panel on r$uc+ surgical sett+ opioid use2 ,data collection on p]iop]ative opioid use4 ,sec4 #fjie4 ,requir+ ! po/+ & p]iodic update ( opioid prescrib+ guidance = ,m$ic>e b5efici>ies4 ,subtitle ,k--,/op ,excessive ,n>cotics 9 our ,retirem5t ,communities ,protection ,sec4 #faja4 ,%ort title4 ,sec4 #fajb4 ,susp5sion ( paym5ts by ,m$ic>e prescription drug plans & ,,ma-,,pd plans p5d+ inve/igations ( cr$ible allegations ( fraud by ph>macies4 ,subtitle ,l--,provid+ ,reliable ,options = ,pati5ts & ,educational ,res\rces ,sec4 #faaa4 ,%ort title4 ,sec4 #faab4 ,requir+ ,m$ic>e ,advantage plans & "p ,d prescription drug plans to include in=mation on risks associat$ ) opioids & cov]age ( nonph>macological !rapies & nonopioid m$ications or devices us$ to treat pa94 ,sec4 #faac4 ,requir+ ,m$ic>e ,advantage plans & prescription drug plans to provide in=mation on ! safe disposal ( prescription drugs4 ,sec4 #faad4 ,revis+ measures us$ "u ! ,hospital ,consum] ,assessm5t ( ,heal?c>e ,provid]s & ,sy/ems survey relat+ to pa9 managem5t4 ,title ,,vii--,o!r ,heal? ,provisions ,subtitle ,a--,syn!tic ,drug ,aw>5ess ,sec4 #gjja4 ,%ort title4 ,sec4 #gjjb4 ,report on effects on public heal? ( syn!tic drug use4 ,subtitle ,b--,emp[]+ ,ph>maci/s 9 ! ,fight ,aga9/ ,opioid ,abuse ,sec4 #gjaa4 ,%ort title4 ,sec4 #gjab4 ,programs & mat]ials = tra9+ on c]ta9 circum/ances "u :i* a ph>maci/ may decl9e to fill a prescription4 ,subtitle ,c--,index+ ,n>cotics1 ,f5tanyl1 & ,opioids ,sec4 #gjba4 ,%ort title4 ,sec4 #gjbb4 ,e/abli%m5t ( sub/ance use disord] in=mation da%bo>d4 ,sec4 #gjbc4 ,int]ag5cy ,sub/ance ,use ,disord] ,coord9at+ ,committee4 ,subtitle ,d--,ensur+ ,access to ,quality ,sob] ,liv+ ,sec4 #gjca4 ,%ort title4 ,sec4 #gjcb4 ,national recov]y h\s+ be/ practices4 ,subtitle ,e--,advanc+ ,cutt+ ,edge ,rese>* ,sec4 #gjda4 ,%ort title4 ,sec4 #gjdb4 ,unique rese>* initiatives4 ,subtitle ,f--,jessie's ,law ,sec4 #gjea4 ,%ort title4 ,sec4 #gjeb4 ,inclusion ( opioid addiction hi/ory 9 pati5t records4 ,sec4 #gjec4 ,communication ) families dur+ em]g5cies4 ,subtitle ,g--,safe ,disposal ( ,unus$ ,m$ication ,sec4 #gjfa4 ,%ort title4 ,sec4 #gjfb4 ,disposal ( controll$ sub/ances ( a deceas$ hospice pati5t by employees ( a qualifi$ hospice program4 ,subtitle ,h--,sub/ance ,use ,disord] ,work=ce ,loan ,repaym5t ,sec4 #gjga4 ,%ort title4 ,sec4 #gjgb4 ,loan repaym5t program = sub/ance use disord] treatm5t employees4 ,subtitle ,i--,prev5t+ ,ov]doses ,:ile 9 ,em]g5cy ,rooms ,sec4 #gjha4 ,%ort title4 ,sec4 #gjhb4 ,program to support em]g5cy room dis*>ge & c>e coord9ation = drug ov]dose pati5ts4 ,subtitle ,j--,alt]natives to ,opioids 9 ! ,em]g5cy ,dep>tm5t ,sec4 #gjia4 ,%ort title4 ,sec4 #gjib4 ,em]g5cy dep>tm5t alt]natives to opioids demon/ration program4 ,subtitle ,k--,/op ,c\nt]feit ,drugs by ,regulat+ & ,enhanc+ ,en=cem5t ,n[ ,sec4 #gaja4 ,%ort title4 ,sec4 #gajb4 ,det5tion1 refusal1 & de/ruction ( drugs (f]$ = importation4 ,sec4 #gajc4 ,notification1 nondi/ribution1 & recall ( adult]at$ or misbr&$ drug products4 ,sec4 #gajd4 ,s+le s\rce patt]n ( %ipm5ts ( adult]at$ or misbr&$ drugs4 ,sec4 #gaje4 ,fund to /r5g!n ef=ts ( ,,fda to combat ! opioid & sub/ance use epidemic4 ,sec4 #gajf4 ,consid]ation ( pot5tial = misuse & abuse requir$ = drug approval4 ,subtitle ,l--,treatm5t1 ,education1 & ,community ,help to ,combat ,addiction ,sec4 #gaaa4 ,%ort title4 ,sec4 #gaab4 ,e/abli%m5t ( ,regional ,c5t]s ( ,excell5ce 9 ,sub/ance ,use ,disord] ,education4 ,subtitle ,m--,guidance f ,national ,m5tal ,heal? & ,sub/ance ,use ,policy ,laboratory ,sec4 #gaba4 ,guidance f ,national ,m5tal ,heal? & ,sub/ance ,use ,policy ,laboratory4 ,subtitle ,n--,compreh5sive ,opioid ,recov]y ,c5t]s ,sec4 #gaca4 ,%ort title4 ,sec4 #gacb4 ,compreh5sive opioid recov]y c5t]s4 ,subtitle ,o--,poison ,c5t] ,network ,enhancem5t ,sec4 #gada4 ,%ort title4 ,sec4 #gadb4 ,reau?orization ( poison control c5t]s national toll-free numb]4 ,sec4 #gadc4 ,reau?orization ( nationwide public aw>5ess campaign to promote poison control c5t] utilization4 ,sec4 #gadd4 ,reau?orization ( ! poison control c5t] grant program4 ,subtitle ,p--,elim9at+ ,opioid ,relat$ ,infecti\s ,diseases ,sec4 #gaea4 ,%ort title4 ,sec4 #gaeb4 ,reau?orization & expansion ( program ( surveillance & education reg>d+ infections associat$ ) illicit drug use & o!r risk factors4 ,subtitle ,q--,bett] ,pa9 ,managem5t ,?r\gh ,bett] ,data ,sec4 #gafa4 ,%ort title4 ,sec4 #gafb4 ,guidance address+ alt]native approa*es to data collection & label+ claims = opioid sp>+4 ,subtitle ,r--,special ,regi/ration = ,telem$ic9e ,cl>ification ,sec4 #gaga4 ,%ort title4 ,sec4 #gagb4 ,deadl9e = int]im f9al regulations = a special regi/ration ,to engage 9 ! practice ( telem$ic9e4 ,subtitle ,s--,pe] ,support ,communities ( ,recov]y ,sec4 #gaha4 ,%ort title4 ,sec4 #gahb4 ,build+ communities ( recov]y4 ,subtitle ,t--,/op ,illicit ,drug ,importation ,sec4 #gaia4 ,%ort title4 ,sec4 #gaib4 ,det5tion1 refusal1 & de/ruction ( drugs (f]$ = importation4 ,sec4 #gaic4 ,seizure4 ,sec4 #gaid4 ,deb>r+ violative individuals or companies4 ,subtitle ,u--,creat+ ,opportunities t ,necessitate ,new & ,enhanc$ ,connections ,t ,improve ,opioid ,navigation ,/rategies ,sec4 #gbja4 ,%ort title4 ,sec4 #gbjb4 ,prev5t+ ov]doses ( controll$ sub/ances4 ,sec4 #gbjc4 ,prescription drug monitor+ program4 ,subtitle ,v--,secur+ ,opioids & ,unus$ ,n>cotics ) ,delib]ate ,disposal & ,packag+ ,sec4 #gbaa4 ,%ort title4 ,sec4 #gbab4 ,improv$ te*nologies1 controls1 or measures ) respect to ! packag+ or disposal ( c]ta9 drugs4 ,subtitle ,w--,po/approval /udy requirem5ts ,sec4 #gbba4 ,po/approval /udy requirem5ts4 ,title ,,viii--,miscellane\s ,subtitle ,a--,syn!tics ,traffick+ & ,ov]dose ,prev5tion ,sec4 #hjja4 ,%ort title2 table ( cont5ts4 ,sec4 #hjjb4 ,cu/oms fees4 ,sec4 #hjjc4 ,m&atory advance electronic in=mation = po/al %ipm5ts4 ,sec4 #hjjd4 ,int]national po/al agreem5ts4 ,sec4 #hjje4 ,co/ rec\pm5t4 ,sec4 #hjjf4 ,developm5t ( te*nology to detect illicit n>cotics4 ,sec4 #hjjg4 ,civil p5alties = po/al %ipm5ts4 ,sec4 #hjjh4 ,report on violations ( arrival1 report+1 entry1 & cle>ance requirem5ts & falsity or lack ( manife/4 ,sec4 #hjji4 ,effective date2 regulations4 ,subtitle ,b--,recogniz+ ,e>ly ,*ildhood ,trauma ,relat$ to ,sub/ance ,abuse ,sec4 #hjaa4 ,%ort title4 ,sec4 #hjab4 ,recogniz+ ,e>ly ,*ildhood ,trauma ,relat$ to ,sub/ance ,abuse4 ,subtitle ,c--,assi/+ ,/ates' ,implem5tation ( ,plans ( ,safe ,c>e ,sec4 #hjba4 ,%ort title4 ,sec4 #hjbb4 ,assi/+ ,/ates ) implem5tation ( plans ( safe c>e4 ,subtitle ,d--,improv+ ! ,f$]al ,response to ,families ,impact$ by ,sub/ance ,use ,disord] ,sec4 #hjca4 ,%ort title4 ,sec4 #hjcb4 ,int]ag5cy ,task ,=ce to ,improve ! ,f$]al ,response to ,families ,impact$ by ,sub/ance ,use ,disord]s4 ,subtitle ,e--,e/abli%m5t ( an ,advisory ,committee on ,opioids & ! ,workplace ,sec4 #hjda4 ,e/abli%m5t ( an ,advisory ,committee on ,opioids & ! ,workplace4 ,subtitle ,f--,vet]ans ,treatm5t ,c\rt ,improvem5t ,sec4 #hjea4 ,%ort title4 ,sec4 #hjeb4 ,hir+ by ,dep>tm5t ( ,vet]ans ,affairs ( additional ,vet]ans ,ju/ice ,outrea* ,speciali/s4 ,subtitle ,g--,pe] support c\nsel+ program = wom5 vet]ans ,sec4 #hjfa4 ,pe] support c\nsel+ program = wom5 vet]ans4 ,subtitle ,h--,treat+ ,b>ri]s to ,prosp]ity ,sec4 #hjga4 ,%ort title4 ,sec4 #hjgb4 ,drug abuse mitigation initiative4 ,subtitle ,i--,support+ ,gr&p>5ts ,rais+ ,gr&*ildr5 ,sec4 #hjha4 ,%ort title4 ,sec4 #hjhb4 ,f9d+s4 ,sec4 #hjhc4 ,advisory ,c\ncil ,to ,support ,gr&p>5ts ,rais+ ,gr&*ildr54 ,sec4 #hjhd4 ,def9itions4 ,subtitle ,j--,reau?oriz+ & ,ext5d+ ,grants = ,recov]y f ,opioid ,use ,programs ,sec4 #hjia4 ,%ort title4 ,sec4 #hjib4 ,reau?orization ( ! compreh5sive opioid abuse grant program4 ,title ,,ix--,,sitsa ,act ,sec4 #ijja4 ,%ort title4 ,sec4 #ijjb4 ,e/abli%m5t ( s*$ule ,a4 ,sec4 #ijjc4 ,tempor>y & p]man5t s*$ul+ ( s*$ule ,a sub/ances4 ,sec4 #ijjd4 ,p5alties4 ,sec4 #ijje4 ,false label+ ( s*$ule ,a controll$ sub/ances4 ,sec4 #ijjf4 ,regi/ration requirem5ts = h&l]s ( s*$ule ,a sub/ances4 ,sec4 #ijjg4 ,additional con=m+ am5dm5ts4 ,sec4 #ijjh4 ,controll$ sub/ance analogues4 ,sec4 #ijji4 ,rules ( con/ruction4 ,sec4 #ijaj4 ,/udy by ,comptroll] ,g5]al4 ,sec4 #ijaa4 ,report on controll$ sub/ance analogues sold by means ( ! ,int]net4 ,sec4 #ijab4 ,controll$ sub/ance analogues4 ,title ,x--,,?rive ,act ,sec4 #ajjja4 ,%ort title4 ,sec4 #ajjjb4 ,demon/ration program to /udy ! impact ( us+ r5tal v\*]s = supportive h\s+ = individuals recov]+ f opioid use disord]s or o!r sub/ance use disord]s4 ,sec4 #ajjjc4 ,repeal ( ,r5tal ,v\*] ,demon/ration ,program4 ,sec4 #ajjjd4 ,demon/ration ,close-,out4 ,sec4 #ajjje4 ,no additional funds au?oriz$4 ,title ,,xi--,,imd ,,c>e ,act ,sec4 #aajja4 ,%ort title4 ,sec4 #aajjb4 ,m$icaid ,/ate plan option to provide s]vices = c]ta9 individuals ) t>get$ ,s,u,ds 9 in/itutions = m5tal diseases4 ,sec4 #aajjc4 ,promot+ value 9 ,m$icaid manag$ c>e4 ,i ,m$icaid ,provisions to ,address ! ,opioid ,crisis #ajja4 ,at-risk y\? ,m$icaid protection 7a7 ,9 g5]al ,section #aijb ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 by /rik+ & at ! end ( p>agraph 7#hb72 7,b7 by /rik+ ! p]iod at ! end ( p>agraph 7#hc7 & ins]t+ 2 &2 & 7,c7 by ins]t+ aft] p>agraph 7#hc7 ! foll[+ new p>agraph3 7#hd7 provide t-- 7,a7 ! ,/ate %all n t]m9ate eligibility = m$ical assi/ance "u ! ,/ate plan = an individual :o is an eligible juv5ile 7z def9$ 9 subsection 7nn77#b77 because ! juv5ile is an inmate ( a public in/itution 7z def9$ 9 subsection 7nn77#c771 b may susp5d cov]age dur+ ! p]iod ! juv5ile is su* an inmate2 7,b7 9 ! case ( an individual :o is an eligible juv5ile describ$ 9 p>agraph 7#b77;,a7 ( subsection 7nn71 ! ,/ate %all1 prior to ! individual's release f su* a public in/itution1 conduct a r$et]m9ation ( eligibility = su* individual ) respect to su* m$ical assi/ance 7)\t requir+ a new application f ! individual7 &1 if ! ,/ate det]m9es pursuant to su* r$et]m9ation t ! individual cont9ues to meet ! eligibility requirem5ts = su* m$ical assi/ance1 ! ,/ate %all re/ore cov]age = su* m$ical assi/ance to su* an individual ^u ! individual's release f su* public in/itution2 & 7,c7 9 ! case ( an individual :o is an eligible juv5ile describ$ 9 p>agraph 7#b77;,b7 ( subsection 7nn71 ! ,/ate %all process any application = m$ical assi/ance submitt$ by1 or on behalf (1 su* individual su* t ! ,/ate makes a det]m9ation ( eligibility = su* individual ) respect to su* m$ical assi/ance ^u release ( su* individual f su* public in/itution4 2 & 7#b7 by add+ at ! end ! foll[+ new subsection3 7nn7 ,juv5ile2 eligible juv5ile2 public in/itution ,= purposes ( subsection 7a77#hd7 & ?is subsection3 7#a7 ,juv5ile ,! t]m juv5ile means an individual :o is-- 7,a7 "u #ba ye>s ( age2 or 7,b7 describ$ 9 subsection 7a77#aj77;,a77i77,,ix74 7#b7 ,eligible juv5ile ,! t]m eligible juv5ile means a juv5ile :o is an inmate ( a public in/itution & :o-- 7,a7 0 det]m9$ eligible = m$ical assi/ance "u ! ,/ate plan imm$iately be=e becom+ an inmate ( su* a public in/itution2 or 7,b7 is det]m9$ eligible = su* m$ical assi/ance :ile an inmate ( a public in/itution4 7#c7 ,inmate ( a public in/itution ,! t]m inmate ( a public in/itution has ! mean+ giv5 su* t]m = purposes ( apply+ ! subdivision 7,a7 foll[+ p>agraph 7#bi7 ( section #aije7;a71 tak+ into acc\nt ! exception 9 su* subdivision = a pati5t ( a m$ical in/itution4 4 7b7 ,no *ange 9 exclusion f m$ical assi/ance = inmates ( public in/itutions ,no?+ 9 ?is section %all be con/ru$ z *ang+ ! exclusion f m$ical assi/ance "u ! subdivision 7,a7 foll[+ p>agraph 7#bi7 ( section #aije7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7a771 includ+ any applicable re/rictions on a ,/ate submitt+ claims = ,f$]al f9ancial p>ticipation "u title ,,xix ( su* ,act = su* assi/ance4 7c7 ,no *ange 9 cont9uity ( eligibility be=e adjudication or s5t5c+ ,no?+ 9 ?is section %all be con/ru$ to m&ate1 enc\rage1 or sugge/ t a ,/ate susp5d or t]m9ate cov]age = individuals be=e !y h be5 adjudicat$ or s5t5c$4 7d7 ,effective date 7#a7 ,9 g5]al ,except z provid$ 9 p>agraph 7#b71 ! am5dm5ts made by subsection 7a7 %all apply to eligibility ( juv5iles :o become inmates ( public in/itutions on or aft] ! date t is #a ye> aft] ! date ( ! enactm5t ( ?is ,act4 7#b7 ,rule = *anges requir+ /ate legislation ,9 ! case ( a ,/ate plan = m$ical assi/ance "u title ,,xix ( ! ,social ,security ,act :i* ! ,secret>y ( ,heal? & ,human ,s]vices det]m9es requires ,/ate legislation 7o!r ?an legislation appropriat+ funds7 9 ord] = ! plan to meet ! additional requirem5ts impos$ by ! am5dm5ts made by subsection 7a71 ! ,/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 #ajjb4 ,heal? ,insurance = ,=m] ,fo/] ,y\? 7a7 ,cov]age cont9uity = =m] fo/] c>e *ildr5 up to age #bf 7#a7 ,9 g5]al ,section #aijb7;a77#aj77;,a77i77,,ix7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#aj77;,a77i77,,ix77 is am5d$-- 7,a7 9 item 7bb71 by /rik+ are n describ$ 9 or enroll$ "u & ins]t+ are n describ$ 9 & are n enroll$ "u2 7,b7 9 item 7cc71 by /rik+ responsibility ( ! ,/ate & ins]t+ responsibility ( a ,/ate2 & 7,c7 9 item 7dd71 by /rik+ ! ,/ate plan "u ?is title or "u a waiv] ( ! & ins]t+ a ,/ate plan "u ?is title or "u a waiv] ( su* a4 7#b7 ,effective date ,! am5dm5ts made by ?is subsection %all take effect ) respect to fo/] y\? :o atta9 #ah ye>s ( age on or aft] ,janu>y #a1 #bjbc4 7b7 ,guidance ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue guidance to ,/ates1 ) respect to ! ,/ate ,m$icaid programs ( su* ,/ates-- 7#a7 on be/ practices =-- 7,a7 remov+ b>ri]s & ensur+ /reaml9$1 timely access to ,m$icaid cov]age = =m] fo/] y\? up to age #bf2 & 7,b7 conduct+ outrea* & rais+ aw>5ess among su* y\? reg>d+ ,m$icaid cov]age options = su* y\?2 & 7#b7 :i* %all include examples ( ,/ates t h successfully ext5d$ ,m$icaid cov]age to =m] fo/] y\? up to age #bf4 #ajjc4 ,demon/ration project to increase sub/ance use provid] capacity "u ! ,m$icaid program ,section #aijc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7aa7 ,demon/ration project to increase sub/ance use provid] capacity 7#a7 ,9 g5]al ,n lat] ?an ! date t is #ahj days aft] ! date ( ! enactm5t ( ?is section1 ! ,secret>y %all1 9 consultation1 z appropriate1 ) ! ,director ( ! ,ag5cy = ,heal?c>e ,rese>* & ,quality & ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use1 conduct a #ed-mon? demon/ration project = ! purpose describ$ 9 p>agraph 7#b7 "u :i* ! ,secret>y %all-- 7,a7 = ! fir/ #ah-mon? p]iod ( su* project1 aw>d plann+ grants describ$ 9 p>agraph 7#c72 & 7,b7 = ! rema9+ #cf-mon? p]iod ( su* project1 provide to ea* ,/ate select$ "u p>agraph 7#d7 paym5ts 9 accordance ) p>agraph 7#e74 7#b7 ,purpose ,! purpose describ$ 9 ?is p>agraph is = ea* ,/ate select$ "u p>agraph 7#d7 to increase ! treatm5t capacity ( provid]s p>ticipat+ "u ! ,/ate plan 7or a waiv] ( su* plan7 to provide sub/ance use disord] treatm5t or recov]y s]vices "u su* plan 7or waiv]7 ?r\gh ! foll[+ activities3 7,a7 ,= ! purpose describ$ 9 p>agraph 7#c77;,c77i71 activities t support an ongo+ assessm5t ( ! behavioral heal? treatm5t ne$s ( ! ,/ate1 tak+ into acc\nt ! matt]s describ$ 9 subclauses 7,i7 ?r\gh 7,,iv7 ( su* p>agraph4 7,b7 ,activities t1 tak+ into acc\nt ! results ( ! assessm5t describ$ 9 subp>agraph 7,a71 support ! recruitm5t1 tra9+1 & provision ( te*nical assi/ance = provid]s p>ticipat+ "u ! ,/ate plan 7or a waiv] ( su* plan7 t (f] sub/ance use disord] treatm5t or recov]y s]vices4 7,c7 ,improv$ reimbursem5t = & expansion (1 ?r\gh ! provision ( education1 tra9+1 & te*nical assi/ance1 ! numb] or treatm5t capacity ( provid]s p>ticipat+ "u ! ,/ate plan 7or waiv]7 t-- 7i7 are au?oriz$ to disp5se drugs approv$ by ! ,food & ,drug ,adm9i/ration = individuals ) a sub/ance use disord] :o ne$ )drawal managem5t or ma9t5ance treatm5t = su* disord]2 7ii7 h 9 effect a regi/ration or waiv] "u section #cjc7;g7 ( ! ,controll$ ,sub/ances ,act = purposes ( disp5s+ n>cotic drugs to individuals = ma9t5ance treatm5t or detoxification treatm5t & are 9 compliance ) any regulation promulgat$ by ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use = purposes ( c>ry+ out ! requirem5ts ( su* section #cjc7;g72 & 7iii7 are qualifi$ "u applicable ,/ate law to provide sub/ance use disord] treatm5t or recov]y s]vices4 7,d7 ,improv$ reimbursem5t = & expansion (1 ?r\gh ! provision ( education1 tra9+1 & te*nical assi/ance1 ! numb] or treatm5t capacity ( provid]s p>ticipat+ "u ! ,/ate plan 7or waiv]7 t h ! qualifications to address ! treatm5t or recov]y ne$s (-- 7i7 individuals enroll$ "u ! ,/ate plan 7or a waiv] ( su* plan7 :o h neonatal ab/95ce syndrome1 9 accordance ) guidel9es issu$ by ! ,am]ican ,academy ( ,p$iatrics & ,am]ican ,college ( ,ob/etricians & ,gynecologi/s relat+ to mat]nal c>e & infant c>e ) respect to neonatal ab/95ce syndrome2 7ii7 pregnant wom51 po/p>tum wom51 & infants1 p>ticul>ly ! concurr5t treatm5t1 z appropriate1 & compreh5sive case managem5t ( pregnant wom51 po/p>tum wom5 & infants1 enroll$ "u ! ,/ate plan 7or a waiv] ( su* plan72 7iii7 adolesc5ts & "y adults betwe5 ! ages ( #ab & #ba enroll$ "u ! ,/ate plan 7or a waiv] ( su* plan72 or 7iv7 ,am]ican ,indian & ,alaska ,native individuals enroll$ "u ! ,/ate plan 7or a waiv] ( su* plan74 7#c7 ,plann+ grants 7,a7 ,9 g5]al ,! ,secret>y %all1 ) respect to ! fir/ #ah-mon? p]iod ( ! demon/ration project conduct$ "u p>agraph 7#a71 aw>d plann+ grants to at lea/ #aj ,/ates select$ 9 accordance ) subp>agraph 7,b7 = purposes ( prep>+ an application describ$ 9 p>agraph 7#d77;,c7 & c>ry+ out ! activities describ$ 9 subp>agraph 7,c74 7,b7 ,selection ,9 select+ ,/ates = purposes ( ?is p>agraph1 ! ,secret>y %all-- 7i7 select ,/ates t h a ,/ate plan 7or waiv] ( ! ,/ate plan7 approv$ "u ?is title2 7ii7 select ,/ates 9 a mann] t ensures geographic div]sity2 & 7iii7 give pref]5ce to ,/ates ) a preval5ce ( sub/ance use disord]s 79 p>ticul> opioid use disord]s7 t is comp>able to or high] ?an ! national av]age preval5ce1 z measur$ by aggregate p] capita drug ov]doses1 or any o!r measure t ! ,secret>y deems appropriate4 7,c7 ,activities describ$ ,activities describ$ 9 ?is subp>agraph are1 ) respect to a ,/ate1 ea* ( ! foll[+3 7i7 ,activities t support ! developm5t ( an initial assessm5t ( ! behavioral heal? treatm5t ne$s ( ! ,/ate to det]m9e ! ext5t to :i* provid]s are ne$$ 7includ+ ! types ( su* provid]s & geographic area ( ne$7 to improve ! network ( provid]s t treat sub/ance use disord]s "u ! ,/ate plan 7or waiv]71 includ+ ! foll[+3 7,i7 ,an e/imate ( ! numb] ( individuals enroll$ "u ! ,/ate plan 7or a waiv] ( su* plan7 :o h a sub/ance use disord]4 7,,ii7 ,in=mation on ! capacity ( provid]s to provide sub/ance use disord] treatm5t or recov]y s]vices to individuals enroll$ "u ! ,/ate plan 7or waiv]71 includ+ in=mation on provid]s :o provide su* s]vices & _! p>ticipation "u ! ,/ate plan 7or waiv]74 7,,iii7 ,in=mation on ! gap 9 sub/ance use disord] treatm5t or recov]y s]vices "u ! ,/ate plan 7or waiv]7 bas$ on ! in=mation describ$ 9 subclauses 7,i7 & 7,,ii74 7,,iv7 ,projections reg>d+ ! ext5t to :i* ! ,/ate p>ticipat+ "u ! demon/ration project w\ld increase ! numb] ( provid]s (f]+ sub/ance use disord] treatm5t or recov]y s]vices "u ! ,/ate plan 7or waiv]7 dur+ ! p]iod ( ! demon/ration project4 7ii7 ,activities t1 tak+ into acc\nt ! results ( ! assessm5t describ$ 9 clause 7i71 support ! developm5t ( ,/ate infra/ructure to1 ) respect to ! provision ( sub/ance use disord] treatm5t or recov]y s]vices "u ! ,/ate plan 7or a waiv] ( su* plan71 recruit prospective provid]s & provide tra9+ & te*nical assi/ance to su* provid]s4 7,d7 ,fund+ ,= purposes ( subp>agraph 7,a71 !re is appropriat$1 out ( any funds 9 ! ,treasury n o!rwise appropriat$1 #ej1jjj1jjj1 to rema9 available until exp5d$4 7#d7 ,po/-plann+ ,/ates 7,a7 ,9 g5]al ,! ,secret>y %all1 ) respect to ! rema9+ #cf-mon? p]iod ( ! demon/ration project conduct$ "u p>agraph 7#a71 select n m ?an #e ,/ates 9 accordance ) subp>agraph 7,b7 = purposes ( c>ry+ out ! activities describ$ 9 p>agraph 7#b7 & receiv+ paym5ts 9 accordance ) p>agraph 7#e74 7,b7 ,selection ,9 select+ ,/ates = purposes ( ?is p>agraph1 ! ,secret>y %all-- 7i7 select ,/ates t receiv$ a plann+ grant "u p>agraph 7#c72 7ii7 select ,/ates t submit to ! ,secret>y an application 9 accordance ) ! requirem5ts 9 subp>agraph 7,c71 tak+ into consid]ation ! quality ( ea* su* application2 7iii7 select ,/ates 9 a mann] t ensures geographic div]sity2 & 7iv7 give pref]5ce to ,/ates ) a preval5ce ( sub/ance use disord]s 79 p>ticul> opioid use disord]s7 t is comp>able to or high] ?an ! national av]age preval5ce1 z measur$ by aggregate p] capita drug ov]doses1 or any o!r measure t ! ,secret>y deems appropriate4 7,c7 ,applications 7i7 ,9 g5]al ,a ,/ate seek+ to be select$ = purposes ( ?is p>agraph %all submit to ! ,secret>y1 at su* "t & 9 su* =m & mann] z ! ,secret>y requires1 an application t includes su* in=mation1 provisions1 & assurances1 z ! ,secret>y may require1 9 addition to ! foll[+3 7,i7 ,a propos$ process = c>ry+ out ! ongo+ assessm5t describ$ 9 p>agraph 7#b77;,a71 tak+ into acc\nt ! results ( ! initial assessm5t describ$ 9 p>agraph 7#c77;,c77i74 7,,ii7 ,a review ( reimbursem5t me?odologies & o!r policies relat$ to sub/ance use disord] treatm5t or recov]y s]vices "u ! ,/ate plan 7or waiv]7 t may create b>ri]s to increas+ ! numb] ( provid]s deliv]+ su* s]vices4 7,,iii7 ,! developm5t ( a plan1 tak+ into acc\nt activities c>ri$ out "u p>agraph 7#c77;,c77ii71 t w result 9 long-t]m & su/a9able provid] networks "u ! ,/ate plan 7or waiv]7 t w (f] a cont9uum ( c>e = sub/ance use disord]s4 ,su* plan %all include ! foll[+3 7aa7 ,specific activities to increase ! numb] ( provid]s 7includ+ provid]s t specialize 9 provid+ sub/ance use disord] treatm5t or recov]y s]vices1 hospitals1 heal? c>e sy/ems1 ,f$]ally qualifi$ heal? c5t]s1 &1 z applicable1 c]tifi$ community behavioral heal? cl9ics7 t (f] sub/ance use disord] treatm5t1 recov]y1 or support s]vices1 includ+ %ort-t]m detoxification s]vices1 outpati5t sub/ance use disord] s]vices1 & evid5ce-bas$ pe] recov]y s]vices4 7bb7 ,/rategies t w inc5tivize provid]s describ$ 9 subp>agraphs 7,c7 & 7,d7 ( p>agraph 7#b7 to obta9 ! necess>y tra9+1 education1 & support to deliv] sub/ance use disord] treatm5t or recov]y s]vices 9 ! ,/ate4 7cc7 ,mile/ones & timel9ess = implem5t+ activities set =? 9 ! plan4 7dd7 ,specific measurable t>gets = increas+ ! sub/ance use disord] treatm5t & recov]y provid] network "u ! ,/ate plan 7or a waiv] ( su* plan74 7,,iv7 ,a propos$ process = report+ ! in=mation requir$ "u p>agraph 7#f77;,a71 includ+ in=mation to assess ! effectiv5ess ( ! ef=ts ( ! ,/ate to exp& ! capacity ( provid]s to deliv] sub/ance use disord] treatm5t or recov]y s]vices dur+ ! p]iod ( ! demon/ration project "u ?is subsection4 7,v7 ,! expect$ f9ancial impact ( ! demon/ration project "u ?is subsection on ! ,/ate4 7,,vi7 ,a description ( all fund+ s\rces available to ! ,/ate to provide sub/ance use disord] treatm5t or recov]y s]vices 9 ! ,/ate4 7,,vii7 ,a prelim9>y plan = h[ ! ,/ate w su/a9 any increase 9 ! capacity ( provid]s to deliv] sub/ance use disord] treatm5t or recov]y s]vices result+ f ! demon/ration project "u ?is subsection aft] ! t]m9ation ( su* demon/ration project4 7,,viii7 ,a description ( h[ ! ,/ate w coord9ate ! goals ( ! demon/ration project ) any waiv] grant$ 7or submitt$ by ! ,/ate & p5d+7 pursuant to section #aaae = ! deliv]y ( sub/ance use s]vices "u ! ,/ate plan1 z applicable4 7ii7 ,consultation ,9 complet+ an application "u clause 7i71 a ,/ate %all consult ) relevant /akehold]s1 includ+ ,m$icaid manag$ c>e plans1 heal? c>e provid]s1 & ,m$icaid b5efici>y advocates1 & include 9 su* application a description ( su* consultation4 7#e7 ,paym5t 7,a7 ,9 g5]al ,= ea* qu>t] occurr+ dur+ ! p]iod = :i* ! demon/ration project is conduct$ 7aft] ! fir/ #ah mon?s ( su* p]iod71 ! ,secret>y %all pay "u ?is subsection1 subject to subp>agraph 7,c71 to ea* ,/ate select$ "u p>agraph 7#d7 an am\nt equal to #hj p]c5t ( s mu* ( ! qualifi$ sums exp5d$ dur+ su* qu>t]4 7,b7 ,qualifi$ sums def9$ ,= purposes ( subp>agraph 7,a71 ! t]m qualifi$ sums means1 ) respect to a ,/ate & a qu>t]1 ! am\nt equal to ! am\nt 7if any7 by :i* ! sums exp5d$ by ! ,/ate dur+ su* qu>t] attributable to sub/ance use treatm5t or recov]y s]vices furni%$ by provid]s p>ticipat+ "u ! ,/ate plan 7or a waiv] ( su* plan7 exce$s #a_/d ( su* sums exp5d$ by ! ,/ate dur+ fiscal ye> #bjah attributable to sub/ance use treatm5t or recov]y s]vices4 7,c7 ,non-duplication ( paym5t ,9 ! case t paym5t is made "u subp>agraph 7,a7 ) respect to exp5ditures = sub/ance use treatm5t or recov]y s]vices furni%$ by provid]s p>ticipat+ "u ! ,/ate plan 7or a waiv] ( su* plan71 paym5t may n also be made "u subsection 7a7 ) respect to exp5ditures = ! same s]vices s furni%$4 7#f7 ,reports 7,a7 ,/ate reports ,a ,/ate receiv+ paym5ts "u p>agraph 7#e7 %all1 = ! p]iod ( ! demon/ration project "u ?is subsection1 submit to ! ,secret>y a qu>t]ly report1 ) respect to exp5ditures = sub/ance use treatm5t or recov]y s]vices = :i* paym5t is made to ! ,/ate "u ?is subsection1 on ! foll[+3 7i7 ,! specific activities ) respect to :i* paym5t "u ?is subsection 0 provid$4 7ii7 ,! numb] ( provid]s t deliv]$ sub/ance use disord] treatm5t or recov]y s]vices 9 ! ,/ate "u ! demon/ration project comp>$ to ! e/imat$ numb] ( provid]s t w\ld h o!rwise deliv]$ su* s]vices 9 ! abs5ce ( su* demon/ration project4 7iii7 ,! numb] ( individuals enroll$ "u ! ,/ate plan 7or a waiv] ( su* plan7 :o receiv$ sub/ance use disord] treatm5t or recov]y s]vices "u ! demon/ration project comp>$ to ! e/imat$ numb] ( su* individuals :o w\ld h o!rwise receiv$ su* s]vices 9 ! abs5ce ( su* demon/ration project4 7iv7 ,o!r matt]s z det]m9$ by ! ,secret>y4 7,b7 ,,cms reports 7i7 ,initial report ,n lat] ?an ,octob] #a1 #bjbj1 ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices %all1 9 consultation ) ! ,director ( ! ,ag5cy = ,heal?c>e ,rese>* & ,quality & ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use1 submit to ,congress an initial report on-- 7,i7 ! ,/ates aw>d$ plann+ grants "u p>agraph 7#c72 7,,ii7 ! crit]ia us$ 9 su* selection2 & 7,,iii7 ! activities c>ri$ out by su* ,/ates "u su* plann+ grants4 7ii7 ,int]im report ,n lat] ?an ,octob] #a1 #bjbb1 ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices %all1 9 consultation ) ! ,director ( ! ,ag5cy = ,heal?c>e ,rese>* & ,quality & ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use1 submit to ,congress an int]im report-- 7,i7 on activities c>ri$ out "u ! demon/ration project "u ?is subsection2 7,,ii7 on ! ext5t to :i* ,/ates select$ "u p>agraph 7#d7 h a*iev$ ! /at$ goals submitt$ 9 _! applications "u subp>agraph 7,c7 ( su* p>agraph2 7,,iii7 ) a description ( ! /r5g?s & limitations ( su* demon/ration project2 & 7,,iv7 ) a plan = ! su/a9ability ( su* project4 7iii7 ,f9al report ,n lat] ?an ,octob] #a1 #bjbd1 ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices %all1 9 consultation ) ! ,director ( ! ,ag5cy = ,heal?c>e ,rese>* & ,quality & ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use1 submit to ,congress a f9al report-- 7,i7 provid+ updates on ! matt]s report$ 9 ! int]im report "u clause 7ii72 7,,ii7 includ+ a description ( any *anges made ) respect to ! demon/ration project "u ?is subsection aft] ! submission ( su* int]im report2 & 7,,iii7 evaluat+ su* demon/ration project4 7,c7 ,,ahrq report ,n lat] ?an #c ye>s aft] ! date ( ! enactm5t ( ?is subsection1 ! ,director ( ! ,ag5cy = ,heal?c>e ,rese>* & ,quality1 on consultation ) ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 %all submit to ,congress a summ>y on ! exp]i5ces ( ,/ates aw>d$ plann+ grants "u p>agraph 7#c7 & ,/ates select$ "u p>agraph 7#d74 7#g7 ,data %>+ & be/ practices ,dur+ ! p]iod ( ! demon/ration project "u ?is subsection1 ! ,secret>y %all1 9 collaboration ) ,/ates select$ "u p>agraph 7#d71 facilitate data %>+ & ! developm5t ( be/ practices betwe5 su* ,/ates & ,/ates t 7 n s select$4 7#h7 ,,cms fund+ ,!re is appropriat$1 out ( any funds 9 ! ,treasury n o!rwise appropriat$1 #e1jjj1jjj to ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices = purposes ( implem5t+ ?is subsection4 ,su* am\nt %all rema9 available until exp5d$4 4 #ajjd4 ,drug managem5t program = at-risk b5efici>ies 7a7 ,9 g5]al ,title ,,xix ( ! ,social ,security ,act is am5d$ by ins]t+ aft] section #aibg 7#db ,u4,s4,c4 #acifr-#h7 ! foll[+ new section3 #aibg;,a4 ,drug managem5t program = at-risk b5efici>ies 7a7 ,9 g5]al ,beg9n+ ,janu>y #a1 #bjbj1 a ,/ate %all op]ate a qualifi$ drug managem5t program "u :i* a ,/ate may enroll c]ta9 at-risk b5efici>ies id5tifi$ by ! ,/ate "u ! program4 7b7 ,qualifi$ drug managem5t program ,= purposes ( ?is section1 ! t]m qualifi$ drug managem5t program means1 ) respect to a ,/ate1 a program c>ri$ out by ! ,/ate 7includ+ ?r\gh a contract ) a ph>macy b5efit manag]7 t provides at lea/ = ! foll[+3 7#a7 ,id5tification ( at-risk individuals ,"u ! program1 ! ,/ate id5tifies1 9 accordance ) subsection 7c71 individuals enroll$ "u ! ,/ate plan 7or waiv] ( ! ,/ate plan7 :o are at-risk b5efici>ies4 7#b7 ,elem5ts ( program 7,a7 ,9 g5]al ,"u ! program1 ! ,/ate1 ) respect to ea* individual id5tifi$ "u p>agraph 7#a7 & enroll$ "u ! program "u p>agraph 7#e7-- 7i7 subject to subp>agraphs 7,b7 & 7,c71 selects at lea/ "o1 b n m ?an ?ree1 heal? c>e provid]s & at lea/ "o1 b n m ?an ?ree1 ph>macies = ea* su* individual = purposes ( clause 7ii71 9 accordance ) a selection process t takes into acc\nt reasonable factors su* z ! individual's previ\s utilization ( items & s]vices f heal? c>e provid]s & ph>macies1 geographic proximity ( ! individual to su* heal? c>e provid]s & ph>macies1 access ( ! individual to heal? c>e1 reasonable travel "t1 in=mation reg>d+ h\s+ /atus1 & any kn[n pref]5ce ( ! individual = a c]ta9 heal? c>e provid] or ph>macy2 & 7ii7 requires t any controll$ sub/ance furni%$ to su* individual dur+ ! p]iod = :i* su* individual is enroll$ "u ! program be prescrib$ by a heal? c>e provid] select$ "u clause 7i7 = su* individual & disp5s$ by a ph>macy select$ "u clause 7i7 = su* individual 9 ord] = su* controll$ sub/ance to be cov]$ "u ! ,/ate plan 7or waiv]74 7,b7 ,b5efici>y pref]5ce ,9 ! case ( an individual receiv+ a notice "u p>agraph 7#c77;,a7 ( be+ id5tifi$ z pot5tially be+ an at-risk b5efici>y describ$ 9 su* p>agraph1 su* individual may submit1 dur+ ! #cj-;day p]iod foll[+ receipt ( su* notice1 pref]5ces = :i* heal? c>e provid]s & ph>macies ! individual w\ld pref] ! ,/ate to select "u subp>agraph 7,a74 ,! ,/ate %all select or *ange ! selection ( heal? c>e provid]s & ph>macies "u subp>agraph 7,a7 = ! individuals bas$ on su* pref]5ces1 except t 9 ! case t ,/ate det]m9es t su* selection 7or *ange ( selection7 ( a heal? c>e provid] or ph>macy "u subp>agraph 7,a7 is contribut+ or w\ld contribute to prescription drug abuse or drug div]sion by ! individual1 ! ,/ate may select or *ange ! selection ( heal? c>e provid] or ph>macy = ! individual )\t reg>d to ! pref]5ces ( ! individual describ$ 9 ?is subp>agraph4 ,if ! ,/ate selects or *anges ! selection pursuant to ! prec$+ s5t5ce )\t reg>d to ! pref]5ces ( ! individual1 ! ,/ate %all provide ! individual ) at lea/ #cj days writt5 notice ( ! selection or *ange ( selection & a rationale = ! selection or *ange4 7,c7 ,treatm5t ( ph>macy ) multiple locations ,= purposes ( subp>agraph 7,a77i71 9 ! case ( a ph>macy t has multiple locations t %>e real-"t electronic prescription data1 all su* locations ( ! ph>macy %all collectively be treat$ z "o ph>macy4 7,d7 ,treatm5t ( exi/+ ,,ffs drug managem5t programs ,9 ! case ( a pati5t review & re/riction program 7z id5tifi$ 9 ! annual report submitt$ to ! ,secret>y "u section #aibg7;g77#c77;,d77 op]at$ by a ,/ate pursuant to section #aiae7;a77#b7 be=e ! date ( ! enactm5t ( ?is section1 su* program %all be treat$ z a qualifi$ drug managem5t program4 7,e7 ,reasonable access ,! program %all ensure1 includ+ ?r\gh waiv] ( elem5ts ( ! program 7includ+ "u subp>agraph 7,a77ii771 reasonable access to heal? c>e 7includ+ access to heal? c>e provid]s & ph>macies ) respect to prescription drugs describ$ 9 subp>agraph 7,a77 9 ! case ( individuals ) multiple resid5ces1 9 ! case ( natural disa/]s & simil> situations1 & 9 ! case ( ! provision ( em]g5cy s]vices 7z def9$ = purposes ( section #ahfj;,d-#d7;c77#e77;,d77ii77,,ii774 7#c7 ,notification to id5tifi$ individuals ,"u ! program1 ! ,/ate provides ea* individual :o is id5tifi$ "u p>agraph 7#a71 prior to enroll+ su* individual "u ! program1 at lea/ "o notification ( ea* ( ! foll[+3 7,a7 ,notice t ! ,/ate has id5tifi$ ! individual z pot5tially be+ an at-risk b5efici>y = abuse or misuse ( a controll$ sub/ance4 7,b7 ,! "n1 address1 & contact in=mation ( ea* heal? c>e provid] & ph>macy t may be select$ = ! individual "u p>agraph 7#b77;,a74 7,c7 ,in=mation describ+ all ,/ate & ,f$]al public heal? res\rces t are design$ to address su* abuse or misuse to :i* ! individual has access1 includ+ m5tal heal? s]vices1 sub/ance use disord] & recov]y s]vices1 & o!r c\nsel+ s]vices4 7,d7 ,notice (1 & in=mation ab\t1 ! "r ( ! individual to-- 7i7 submit pref]5ces ( ! individual = heal? c>e provid]s & ph>macies to be select$ "u p>agraph 7#b77;,a71 includ+ z describ$ 9 p>agraph 7#b77;,b72 7ii7 appeal "u p>agraph 7#d7-- 7,i7 su* id5tification describ$ 9 subp>agraph 7,a72 & 7,,ii7 ! selection ( heal? c>e provid]s & ph>macies "u p>agraph 7#b77;,a74 7,e7 ,an explanation ( ! mean+ & consequ5ces ( ! id5tification ( ! individual z pot5tially be+ an at-risk b5efici>y = abuse or misuse ( a controll$ sub/ance1 includ+ an explanation ( ! program4 7,f7 ,in=mation1 includ+ a contact li/ & cle> in/ructions1 t expla9 h[ ! individual c contact ! appropriate entities adm9i/]+ ! program 9 ord] to submit pref]5ces describ$ 9 p>agraph 7#b77;,b7 & any o!r communications relat+ to ! program4 7#d7 ,appeals process ,"u ! program1 ! ,/ate provides = an appeals process "u :i*1 ) respect to an individual id5tifi$ "u p>agraph 7#a7-- 7,a7 su* individual may appeal-- 7i7 su* id5tification2 & 7ii7 ! selection ( a heal? c>e provid] or ph>macy "u p>agraph 7#b77;,a72 7,b7 9 ! case ( an appeal describ$ 9 subp>agraph 7,a77ii71 ! ,/ate %all accommodate ! heal? c>e provid] or ph>macy pref]r$ by ! individual = selection = purposes ( p>agraph 7#b77;,a71 unless ! ,/ate det]m9es t a *ange to ! selection ( heal? c>e provid] or ph>macy "u su* p>agraph is contribut+ or w\ld contribute to prescription drug abuse or drug div]sion by ! individual2 7,c7 su* individual is provid$ a p]iod ( n less ?an #cj days foll[+ ! date ( receipt ( ! notice describ$ 9 p>agraph 7#c7 to submit su* appeal2 & 7,d7 ! ,/ate mu/ make a det]m9ation ) respect to an appeal describ$ 9 subp>agraph 7,a71 & notify ! individual ( su* det]m9ation1 prior to enrollm5t ( su* individual 9 ! program4 7#e7 ,enrollm5t ,"u ! program1 ! ,/ate initially enrolls individuals :o are id5tifi$ "u p>agraph 7#a7 9 ! program = a #ab-mon? p]iod-- 7,a7 9 ! case ( su* an individual :o does n submit an appeal "u p>agraph 7#d7 )9 ! p]iod appli$ by ! ,/ate pursuant to subp>agraph 7,c7 ( su* p>agraph1 beg9n+ on ! day aft] ! la/ day ( su* p]iod2 & 7,b7 9 ! case ( su* an individual :o does submit an appeal "u p>agraph 7#d7 )9 ! p]iod appli$ by ! ,/ate pursuant to subp>agraph 7,c7 ( su* p>agraph b su* appeal is d5i$1 beg9n+ n lat] ?an #cj days aft] ! date ( su* d5ial4 7#f7 ,notification ( heal? c>e provid]s & ph>macies ,"u ! program1 ! ,/ate provides to ea* heal? c>e provid] & ph>macy select$ = an individual "u p>agraph 7#b7-- 7,a7 notification t ! individual is an at-risk b5efici>y enroll$ "u ! program & t ! provid] or ph>macy has be5 select$ = ! individual "u p>agraph 7#b72 7,b7 in=mation on su* program & ! role ( be+ s select$2 & 7,c7 a process ?r\gh :i* ! provid] or ph>macy c submit a conc]n or compla9t ) respect to be+ s select$4 7#g7 ,cont9uation ( enrollm5t ,"u ! program1 ! ,/ate1 ) respect to an individual enroll$ "u ! program1 provides = a process to-- 7,a7 n lat] ?an #cj days be=e ! end ( ! #ab-mon? p]iod = :i* ! individual is s enroll$ pursuant to p>agraph 7#e7-- 7i7 assess1 9 accordance ) publicly available evid5ce-bas$ guidel9es1 :e!r or n su* individual %\ld cont9ue to be enroll$ "u ! program2 & 7ii7 notify su* individual ( ! results ( ! assessm5t "u clause 7i72 7,b7 cont9ue1 subject to subp>agraph 7,c71 enrollm5t ( su* individual if su* assessm5t recomm5ds su* cont9uation2 & 7,c7 appeal ! cont9uation ( enrollm5t 9 accordance ) ! appeals process describ$ 9 p>agraph 7#d74 7c7 ,at-,risk b5efici>y 7#a7 ,id5tification ,= purposes ( ?is section1 a ,/ate %all id5tify an individual enroll$ "u ! ,/ate plan 7or waiv] ( ! ,/ate plan7 z an at-risk b5efici>y if ! individual is n an exempt$ individual describ$ 9 p>agraph 7#b7 &-- 7,a7 is id5tifi$ z su* an at-risk b5efici>y ?r\gh ! use ( publicly available evid5ce-bas$ guidel9es t indicate misuse or abuse ( a controll$ sub/ance2 or 7,b7 ! ,/ate receiv$ notification f a ,,pdp sponsor or ,m$ic>e ,advantage organization t su* individual 0 id5tifi$ z be+ an at-risk b5efici>y = prescription drug abuse = enrollm5t 9 a drug managem5t program e/abli%$ by ! sponsor or organization pursuant to section #ahfj;,d-#d7;c77#e7 & su* id5tification has n be5 t]m9at$ "u subp>agraph 7,f7 ( su* section4 7#b7 ,exempt$ individual describ$ ,= purposes ( p>agraph 7#a71 an exempt$ individual describ$ 9 ?is p>agraph is an individual :o-- 7,a7 is receiv+-- 7i7 hospice or palliative c>e2 or 7ii7 treatm5t = canc]2 7,b7 is a resid5t ( a long-t]m c>e facility1 ( a facility describ$ 9 section #aije7;d71 or ( ano!r facility = :i* frequ5tly abus$ drugs are disp5s$ = resid5ts ?r\gh a contract ) a s+le ph>macy2 or 7,c7 ! ,/ate elects to treat z an exempt$ individual = purposes ( p>agraph 7#a74 7d7 ,application ( privacy rules cl>ification ,! ,secret>y %all cl>ify privacy requirem5ts1 includ+ requirem5ts "u ! regulations promulgat$ pursuant to section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7#db ,u4,s4,c4 #acbj;d-#b note71 relat$ to ! %>+ ( data "u subsection 7b77#f7 9 ! same mann] z ! ,secret>y is requir$ "u subp>agraph 7,j7 ( section #ahfj;,d-#d7;c77#e7 to cl>ify privacy requirem5ts relat$ to ! %>+ ( data describ$ 9 su* subp>agraph4 7e7 ,reports 7#a7 ,annual reports ,a ,/ate op]at+ a qualifi$ drug managem5t program %all include 9 ! annual report submitt$ to ! ,secret>y "u section #aibg7;g77#c77;,d71 beg9n+ ) su* reports submitt$ = #bjba1 ! foll[+ in=mation3 7,a7 ,! numb] ( individuals enroll$ "u ! ,/ate plan 7or waiv] ( ! ,/ate plan7 :o are enroll$ "u ! program & ! p]c5tage ( individuals enroll$ "u ! ,/ate plan 7or waiv]7 :o are enroll$ "u su* program4 7,b7 ,! numb] ( prescriptions = controll$ sub/ances t 7 disp5s$ p] mon? dur+ ea* su* ye> p] individual enroll$ "u ! program1 includ+ ! daily morph9e milligram equival5ts & ! quantity prescrib$ = ea* su* prescription4 7,c7 ,! numb] ( ph>macies fill+ prescriptions = controll$ sub/ances = individuals enroll$ "u su* program4 7,d7 ,! numb] ( heal? c>e provid]s writ+ prescriptions = controll$ sub/ances 7o!r ?an prescriptions = a refill7 = individuals enroll$ "u su* program4 7,e7 ,any o!r data t ! ,secret>y may require4 7,f7 ,any report submitt$ by a manag$ c>e entity "u subsection 7f77#a77;,b7 ) respect to ! ye> involv$4 ,= ea* su* report = a ye> aft] #bjba1 ! in=mation describ$ 9 ?is p>agraph %all be provid$ 9 a mann] t comp>es su* in=mation ) respect to ! prior cal5d> ye> to su* in=mation ) respect to ! second prior cal5d> ye>4 7#b7 ,,macpac reports & review ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is section1 ! ,m$icaid & ,,*ip ,paym5t & ,access ,commission 79 ?is section ref]r$ to z ,,macpac71 9 consultation ) ! ,national ,association ( ,m$icaid ,directors1 ph>macy b5efit manag]s1 manag$ c>e organizations1 heal? c>e provid]s 7includ+ ph>maci/s71 b5efici>y advocates1 & o!r /akehold]s1 %all publi% a report t includes-- 7,a7 be/ practices = op]at+ drug managem5t programs1 bas$ on a review ( a repres5tative sample ( ,/ates adm9i/]+ su* a program2 7,b7 a summ>y ( ! exp]i5ce ( ! appeals process "u drug managem5t programs op]at$ by sev]al ,/ates1 su* z ! frequ5cy at :i* individuals appeal$ ! id5tification ( be+ an at-risk individual1 ! frequ5cy at :i* individuals appeal$ ! selection ( a heal? c>e provid] or ph>macy "u su* a program1 ! timeframes = su* appeals1 a summ>y ( ! reasons = su* appeals1 & ! design ( su* appeals processes2 7,c7 a summ>y ( tr5ds & ! effectiv5ess ( qualifi$ drug managem5t programs op]at$ "u ?is section2 & 7,d7 recomm5dations to ,/ates on h[ improvem5ts c be made ) respect to ! op]ation ( su* programs4 ,9 report+ on ,/ate practices1 ! ,,macpac %all consid] h[ su* programs h be5 implem5t$ 9 rural areas1 "u fee-=-s]vice z well z manag$ c>e arrangem5ts1 & ! ext5t to :i* su* programs h result$ 9 increas$ effici5cies to su* ,/ates or to ! ,f$]al ,gov]nm5t "u ?is title4 7#c7 ,report on plan = coord9at$ c>e ,n lat] ?an ,janu>y #a1 #bjba1 ea* ,/ate op]at+ a qualifi$ drug managem5t program %all submit to ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices a report on h[ su* ,/ate plans to provide coord9at$ c>e = individuals enroll$ "u ! ,/ate plan 7or waiv] ( ! ,/ate plan7 &-- 7,a7 :o are enroll$ "u ! program2 or 7,b7 :o are enroll$ ) a manag$ c>e entity & enroll$ "u su* a qualifi$ drug managem5t program op]at$ by su* entity4 7f7 ,applicability to manag$ c>e entities 7#a7 ,9 g5]al ,) respect to any contract t a ,/ate ent]s into on or aft] ,janu>y #a1 #bjbj1 ) a manag$ c>e entity 7z def9$ 9 section #aicb7;a77#a77;,b77 pursuant to section #aijc7m71 ! ,/ate %all1 z a condition ( ! contract1 require ! manag$ c>e entity-- 7,a7 to op]ate a qualifi$ drug managem5t program 7z def9$ 9 subsection 7b77 = at-risk b5efici>ies :o are enroll$ ) su* entity & id5tifi$ by ! manag$ c>e entity by means ( application ( p>agraph 7#b72 7,b7 to submit to ! ,/ate an annual report on ! matt]s describ$ 9 subp>agraphs 7,a7 ?r\gh 7,e7 ( subsection 7e77#a72 & 7,c7 to submit to ! ,/ate a li/ 7& z necess>y update su* li/7 ( individuals enroll$ ) su* entity "u ! qualifi$ drug managem5t program op]at$ by su* entity "u subp>agraph 7,a7 = purposes ( all[+ ,/ate plans = :i* m$ical assi/ance is paid on a fee-=-s]vice basis to h access to su* in=mation4 7#b7 ,application ,= purposes ( apply+1 ) respect to a manag$ c>e entity-- 7,a7 "u p>agraph 7#a77;,a7-- 7i7 ! def9ition ( ! t]m qualifi$ drug managem5t program "u subsection 7b71 o!r ?an p>agraph 7#b77;,d7 ( su* subsection2 & 7ii7 ! provisions ( p>agraphs 7#a7 & 7#b7 ( subsection 7c72 & 7,b7 "u p>agraph 7#a77;,b71 ! report requirem5ts describ$ 9 subp>agraphs 7,a7 ?r\gh 7,e7 ( subsection 7e77#a72 ea* ref]5ce 9 su* subsection 7b7 & p>agraphs ( subsection 7c7 to a ,/ate or ! ,/ate 7o!r ?an to a ,/ate plan or ! ,/ate plan7 %all be deem$ a ref]5ce to ! manag$ c>e entity1 ea* ref]5ce "u su* subsection1 p>agraphs1 or subp>agraphs to individuals enroll$ "u ! ,/ate plan 7or waiv] ( ! ,/ate plan7 %all be deem$ a ref]5ce to individuals enroll$ ) su* entity1 & ea* ref]5ce "u su* subsection1 p>agraphs1 or subp>agraphs to individuals enroll$ "u ! qualifi$ drug managem5t program op]at$ by ! ,/ate %all be deem$ a ref]5ce to individuals enroll$ "u ! qualifi$ drug managem5t program op]at$ by ! manag$ c>e entity4 7g7 ,controll$ sub/ance def9$ ,= purposes ( ?is section1 ! t]m controll$ sub/ance means a drug t is includ$ 9 s*$ule ,,ii1 ,,iii1 or ,,iv ( section #bjb7;c7 ( ! ,controll$ ,sub/ances ,act1 or any comb9ation !re(1 z specifi$ by ! ,/ate4 4 7b7 ,guidance on at-,risk population transition+ betwe5 ,m$icaid ,,ffs & manag$ c>e ,n lat] ?an ,octob] #a1 #bjai1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue guidance = ,/ate ,m$icaid programs1 ) respect to individuals :o are enroll$ "u a ,/ate plan 7or waiv] ( su* plan7 "u title ,,xix ( ! ,social ,security ,act & "u a drug managem5t program1 = purposes ( provid+ be/ practices-- 7#a7 = transition+1 z applicable1 su* individuals f fee-=-s]vice ,m$icaid 7& su* a program op]at$ by ! ,/ate7 to receiv+ m$ical assi/ance "u su* title ?r\gh a manag$ c>e entity 7z def9$ 9 section #aicb7;a77#a77;,b7 ( ! ,social ,security ,act7 ) a contract t ) ! ,/ate pursuant to section #aijc7m7 ( su* ,act 7& su* a program op]at$ by su* entity72 & 7#b7 = transition+1 z applicable1 su* individuals f receiv+ m$ical assi/ance "u su* title ?r\gh a manag$ c>e entity 7z def9$ 9 section #aicb7;a77#a77;,b7 ( ! ,social ,security ,act7 ) a contract t ) ! ,/ate pursuant to section #aijc7m7 ( su* ,act 7& su* a program op]at$ by su* entity7 to fee-=-s]vice ,m$icaid 7& su* a program op]at$ by ! ,/ate74 7c7 ,guidance on at-,risk population transition+ to ,m$ic>e 7#a7 ,9 g5]al ,n lat] ?an ,janu>y #a1 #bjbj1 ! ,secret>y ( ,heal? & ,human ,s]vices1 aft] consultation ) ! ,f$]al ,coord9at$ ,heal? ,c>e ,(fice e/abli%$ "u section #bfjb ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #acae;b71 %all issue guidance = ,/ate ,m$icaid programs1 ) respect to transition+ individuals1 provid+ =-- 7,a7 notification to be submitt$ by ! ,/ate to ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices & su* individuals ( ! /atus ( su* individuals z transition+ individuals2 7,b7 notification to su* individuals ab\t enrollm5t "u a prescription drug plan "u "p ,d ( su* title or "u a ,,ma-,,pd plan "u "p ,c ( su* title2 7,c7 be/ practices = transition+ su* individuals to su* a plan2 & 7,d7 be/ practices = coord9ation betwe5 ! qualifi$ drug managem5t program 7z describ$ 9 section #aibg;,a7b7 ( ! ,social ,security ,act1 z add$ by subsection 7a77 c>ri$ out by ! ,/ate & a drug managem5t program c>ri$ out "u su* a plan pursuant to section #ahfj;,d-#d7;c77#e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aj7;c77#e774 7#b7 ,transition+ individuals ,= purposes ( p>agraph 7#a71 a transition+ individual is an individual :o1 ) respect to a mon?-- 7,a7 is enroll$ "u ! ,/ate plan 7or waiv] ( ! ,/ate plan7 & "u ! qualifi$ drug managem5t program 7z describ$ 9 section #aibg;,a7b7 ( ! ,social ,security ,act1 z add$ by subsection 7a77 c>ri$ out by ! ,/ate2 & 7,b7 is expect$ to become eligible = ! ,m$ic>e program "u title ,,xviii ( su* ,act dur+ ! subsequ5t #ab-mon? p]iod4 #ajje4 ,m$icaid drug review & utilization 7a7 ,m$icaid drug utilization review 7#a7 ,/ate plan requirem5t ,section #aijb7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a771 z am5d$ by section #aja1 is fur!r am5d$-- 7,a7 9 p>agraph 7#hc71 at ! end1 by /rik+ &2 7,b7 9 p>agraph 7#hd71 at ! end1 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,c7 by ins]t+ aft] p>agraph 7#hd7 ! foll[+ new p>agraph3 7#he7 provide t ! ,/ate is 9 compliance ) ! drug review & utilization requirem5ts "u subsection 7oo77#a74 4 7#b7 ,drug review & utilization requirem5ts ,section #aijb ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a71 z am5d$ by section #aja1 is fur!r am5d$ by add+ at ! end ! foll[+ new subsection3 7oo7 ,drug review & utilization requirem5ts 7#a7 ,9 g5]al ,= purposes ( subsection 7a77#he71 ! drug review & utilization requirem5ts "u ?is subsection are1 subject to p>agraph 7#c7 & beg9n+ ,octob] #a1 #bjai1 ! foll[+3 7,a7 ,claims review limitations 7i7 ,9 g5]al ,! ,/ate has 9 place-- 7,i7 safety edits 7z specifi$ by ! ,/ate7 = subsequ5t fills = opioids & a claims review automat$ process 7z design$ & implem5t$ by ! ,/ate7 t indicates :5 an individual enroll$ "u ! ,/ate plan 7or "u a waiv] ( ! ,/ate plan7 is prescrib$ a subsequ5t fill ( opioids 9 excess ( any limitation t may be id5tifi$ by ! ,/ate2 7,,ii7 safety edits 7z specifi$ by ! ,/ate7 on ! maximum daily morph9e equival5t t c be prescrib$ to an individual enroll$ "u ! ,/ate plan 7or "u a waiv] ( ! ,/ate plan7 = treatm5t ( *ronic pa9 & a claims review automat$ process 7z design$ & implem5t$ by ! ,/ate7 t indicates :5 an individual enroll$ "u ! plan 7or waiv]7 is prescrib$ ! morph9e equival5t = su* treatm5t 9 excess ( any limitation t may be id5tifi$ by ! ,/ate2 & 7,,iii7 a claims review automat$ process 7z design$ & implem5t$ by ! ,/ate7 t monitors :5 an individual enroll$ "u ! ,/ate plan 7or "u a waiv] ( ! ,/ate plan7 is concurr5tly prescrib$ opioids &-- 7aa7 b5zodiazep9es2 or 7bb7 antipsy*otics4 7ii7 ,manag$ c>e entities ,! ,/ate requires ea* manag$ c>e entity 7z def9$ 9 section #aicb7;a77#a77;,b77 ) respect to :i* ! ,/ate has a contract "u section #aijc7m7 or "u section #aije7t77#c7 to h 9 place1 subject to p>agraph 7#c71 ) respect to individuals :o are eligible = m$ical assi/ance "u ! ,/ate plan 7or "u a waiv] ( ! ,/ate plan7 & :o are enroll$ ) ! entity1 ! limitations describ$ 9 subclauses 7,i7 & 7,,ii7 ( clause 7i7 & a claims review automat$ process describ$ 9 subclause 7,,iii7 ( su* clause4 7iii7 ,rules ( con/ruction ,no?+ 9 ?is subp>agraph may be con/ru$ z prohibit+ a ,/ate or manag$ c>e entity f design+ & implem5t+ a claims review automat$ process "u ?is subp>agraph t provides = prospective or retrospective reviews ( claims4 ,no?+ 9 ?is subp>agraph %all be und]/ood z prohibit+ ! ex]cise ( cl9ical judgm5t f a provid] enroll$ z a p>ticipat+ provid] 9 a ,/ate plan 7or waiv] ( ! ,/ate plan7 or contract+ ) a manag$ c>e entity reg>d+ ! be/ items & s]vices = an individual enroll$ "u su* ,/ate plan 7or waiv]74 7,b7 ,program to monitor antipsy*otic m$ications by *ildr5 ,! ,/ate has 9 place a program 7z design$ & implem5t$ by ! ,/ate7 to monitor & manage ! appropriate use ( antipsy*otic m$ications by *ildr5 enroll$ "u ! ,/ate plan 7or "u a waiv] ( ! ,/ate plan7 & submits annually to ! ,secret>y su* in=mation z ! ,secret>y may require on activities c>ri$ out "u su* program = individuals n m ?an ! age ( #ah ye>s g5]ally & *ildr5 9 fo/] c>e specifically4 7,c7 ,fraud & abuse id5tification ,! ,/ate has 9 place a process 7z design$ & implem5t$ by ! ,/ate7 t id5tifies pot5tial fraud or abuse ( controll$ sub/ances by individuals enroll$ "u ! ,/ate plan 7or "u a waiv] ( ! ,/ate plan71 heal? c>e provid]s prescrib+ drugs to individuals s enroll$1 & ph>macies disp5s+ drugs to individuals s enroll$4 7,d7 ,reports ,! ,/ate %all include 9 ! annual report submitt$ to ! ,secret>y "u section #aibg7;g77#c77;,d7 in=mation on ! limitations1 requirem5t1 program1 & processes appli$ by ! ,/ate "u subp>agraphs 7,a7 ?r\gh 7,c7 9 accordance ) su* mann] & "t z specifi$ by ! ,secret>y4 7,e7 ,cl>ification ,no?+ %all prev5t a ,/ate f satisfy+ ! requirem5t-- 7i7 describ$ 9 subp>agraph 7,a7 by hav+ safety edits or a claims review automat$ process describ$ 9 su* subp>agraph t 0 9 place be=e ,octob] #a1 #bjai2 7ii7 describ$ 9 subp>agraph 7,b7 by hav+ a program describ$ 9 su* subp>agraph t 0 9 place be=e su* date2 or 7iii7 describ$ 9 subp>agraph 7,c7 by hav+ a process describ$ 9 su* subp>agraph t 0 9 place be=e su* date4 7#b7 ,annual report by ,secret>y ,= ea* fiscal ye> beg9n+ ) fiscal ye> #bjbj1 ! ,secret>y %all submit to ,congress a report on ! mo/ rec5t in=mation submitt$ by ,/ates "u p>agraph 7#a77;,d74 7#c7 ,exceptions 7,a7 ,c]ta9 individuals exempt$ ,! drug review & utilization requirem5ts "u ?is subsection %all n apply ) respect to an individual :o-- 7i7 is receiv+-- 7,i7 hospice or palliative c>e2 or 7,,ii7 treatm5t = canc]2 7ii7 is a resid5t ( a long-t]m c>e facility1 ( a facility describ$ 9 section #aije7;d71 or ( ano!r facility = :i* frequ5tly abus$ drugs are disp5s$ = resid5ts ?r\gh a contract ) a s+le ph>macy2 or 7iii7 ! ,/ate elects to treat z exempt$ f su* requirem5ts4 7,b7 ,exception relat+ to ensur+ access ,9 ord] to ensure reasonable access to heal? c>e1 ! ,secret>y %all waive ! drug review & utilization requirem5ts "u ?is subsection1 ) respect to a ,/ate1 9 ! case ( natural disa/]s & simil> situations1 & 9 ! case ( ! provision ( em]g5cy s]vices 7z def9$ = purposes ( section #ahfj;,d-#d7;c77#e77;,d77ii77,,ii774 4 7#c7 ,manag$ c>e entities ,section #aicb ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#b7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7i7 ,drug utilization review activities & requirem5ts ,beg9n+ n lat] ?an ,octob] #a1 #bjai1 ea* contract "u a ,/ate plan ) a manag$ c>e entity 7o!r ?an a prim>y c>e case manag]7 "u section #aijc7m7 %all provide t ! entity is 9 compliance ) ! applicable provisions ( section #dch4c7s77#b7 ( title #db ( ! ,code ( ,f$]al ,regulations1 section #dhc4c7s77#d77 ( su* title1 & section #dhc4c7s77#e7 ( su* title1 z su* provisions 7 9 effect on ,m>* #ca1 #bjah4 4 7b7 ,id5tify+ & address+ inappropriate prescrib+ & bill+ practices "u ,m$icaid 7#a7 ,9 g5]al ,section #aibg7;g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;g77 is am5d$-- 7,a7 9 p>agraph 7#a77;,a7-- 7i7 by /rik+ ( section #aijc7;i77#aj77;,b7 & ins]t+ ( section #aijb7;a77#ed72 7ii7 by /rik+ 1 by n lat] ?an ,janu>y #a1 #aiic12 7iii7 by ins]t+ aft] gross ov]use1 ! foll[+3 excessive utilization12 & 7iv7 by /rik+ or inappropriate or m$ically unnecess>y c>e & ins]t+ inappropriate or m$ically unnecess>y c>e1 or prescrib+ or bill+ practices t indicate abuse or excessive utilization2 & 7,b7 9 p>agraph 7#b77;,b7-- 7i7 by ins]t+ aft] gross ov]use1 ! foll[+3 excessive utilization12 & 7ii7 by /rik+ or inappropriate or m$ically unnecess>y c>e & ins]t+ inappropriate or m$ically unnecess>y c>e1 or prescrib+ or bill+ practices t indicate abuse or excessive utilization4 7#b7 ,effective date ,! am5dm5ts made by p>agraph 7#a7 %all take effect ) respect to retrospective drug use reviews conduct$ on or aft] ,octob] #a1 #bjbj4 #ajjf4 ,guidance to improve c>e = infants ) neonatal ab/95ce syndrome & _! mo!rs2 ,,gao /udy on gaps 9 ,m$icaid cov]age = pregnant & po/p>tum wom5 ) sub/ance use disord] 7a7 ,guidance ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue guidance to improve c>e = infants ) neonatal ab/95ce syndrome & _! families4 ,su* guidance %all include-- 7#a7 ! types ( s]vices1 includ+ po/-dis*>ge s]vices & p>5t+ supports1 = families ( babies ) neonatal ab/95ce syndrome t ,/ates may cov] "u ! ,m$icaid program "u title ,,xix ( ! ,social ,security ,act2 7#b7 be/ practices f ,/ates ) respect to innovative or evid5c$-bas$ paym5t models t focus on prev5tion1 scre5+1 treatm5t1 plans ( safe c>e1 & po/-dis*>ge s]vices = mo!rs & fa!rs ) sub/ance use disord]s & babies ) neonatal ab/95ce syndrome t improve c>e & cl9ical outcomes2 7#c7 recomm5dations = ,/ates on available f9anc+ options "u ! ,m$icaid program "u title ,,xix ( su* ,act & "u ! ,*ildr5's ,heal? ,insurance ,program "u title ,,xxi ( su* ,act = ,*ildr5's ,heal? ,insurance ,program ,heal? ,s]vices ,initiative funds = p>5ts ) sub/ance use disord]s1 infants ) neonatal ab/95ce syndrome1 & home visit+ s]vices2 & 7#d7 guidance & te*nical assi/ance to ,/ate ,m$icaid ag5cies reg>d+ additional flexibilities & inc5tives relat$ to scre5+1 prev5tion1 & po/-dis*>ge s]vices1 includ+ p>5t+ supports4 7b7 ,,gao /udy ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy1 & submit to ,congress a report1 address+ gaps 9 cov]age = pregnant wom5 ) sub/ance use disord] "u ! ,m$icaid program "u title ,,xix ( ! ,social ,security ,act1 & gaps 9 cov]age = po/p>tum wom5 ) sub/ance use disord] :o _h cov]age dur+ _! pregnancy "u ! ,m$icaid program "u su* title4 #ajjg4 ,m$icaid heal? homes = opioid-use-disord] ,m$icaid enrollees 7a7 ,ext5sion ( enhanc$ ,,fmap = c]ta9 heal? homes = individuals ) sub/ance use disord]s ,section #aide ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifw-#d7 is am5d$-- 7#a7 9 subsection 7c7-- 7,a7 9 p>agraph 7#a71 by ins]t+ subject to p>agraph 7#d71 aft] except t12 & 7,b7 by add+ at ! end ! foll[+ new p>agraph3 7#d7 ,special rule relat+ to sub/ance use disord] heal? homes 7,a7 ,9 g5]al ,9 ! case ( a ,/ate ) an ,,sud-focus$ ,/ate plan am5dm5t approv$ by ! ,secret>y on or aft] ,octob] #a1 #bjah1 ! ,secret>y may1 at ! reque/ ( ! ,/ate1 ext5d ! application ( ! ,f$]al m$ical assi/ance p]c5tage describ$ 9 p>agraph 7#a7 to paym5ts = ! provision ( heal? home s]vices to ,,sud-eligible individuals "u su* ,/ate plan am5dm5t1 9 addition to ! fir/ #h fiscal ye> qu>t]s ! ,/ate plan am5dm5t is 9 effect1 = ! subsequ5t #b fiscal ye> qu>t]s t ! ,/ate plan am5dm5t is 9 effect4 ,no?+ 9 ?is section %all be con/ru$ z prohibit+ a ,/ate ) a ,/ate plan am5dm5t t is approv$ "u ?is section & t is n an ,,sud-focus$ ,/ate plan am5dm5t f additionally hav+ approv$ on or aft] su* date an ,,sud-focus$ ,/ate plan am5dm5t "u ?is section1 includ+ = purposes ( application ( ?is p>agraph4 7,b7 ,report requirem5ts ,9 ! case ( a ,/ate ) an ,,sud-focus$ ,/ate plan am5dm5t = :i* ! application ( ! ,f$]al m$ical assi/ance p]c5tage has be5 ext5d$ "u subp>agraph 7,a71 su* ,/ate %all1 at ! end ( ! p]iod ( su* ,/ate plan am5dm5t1 submit to ! ,secret>y a report on ! foll[+1 ) respect to ,,sud-eligible individuals provid$ heal? home s]vices "u su* ,/ate plan am5dm5t3 7i7 ,! quality ( heal? c>e provid$ to su* individuals1 ) a focus on outcomes relevant to ! recov]y ( ea* su* individual4 7ii7 ,! access ( su* individuals to heal? c>e4 7iii7 ,! total exp5ditures ( su* individuals = heal? c>e4 ,= purposes ( ?is subp>agraph1 ! ,secret>y %all specify all applicable measures = det]m9+ quality1 access1 & exp5ditures4 7,c7 ,be/ practices ,n lat] ?an ,octob] #a1 #bjbj1 ! ,secret>y %all make publicly available on ! ,int]net website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices be/ practices = design+ & implem5t+ an ,,sud-focus$ ,/ate plan am5dm5t1 bas$ on ! exp]i5ces ( ,/ates t h ,/ate plan am5dm5ts approv$ "u ?is section t include ,,sud-eligible individuals4 7,d7 ,def9itions ,= purposes ( ?is p>agraph3 7i7 ,,sud-eligible individuals ,! t]m ,,sud-eligible individual means1 ) respect to a ,/ate1 an individual :o satisfies all ( ! foll[+3 7,i7 ,! individual is an eligible individual ) *ronic conditions4 7,,ii7 ,! individual is an individual ) a sub/ance use disord]4 7,,iii7 ,! individual has n previ\sly receiv$ heal? home s]vices "u any o!r ,/ate plan am5dm5t approv$ = ! ,/ate "u ?is section by ! ,secret>y4 7ii7 ,,sud-focus$ ,/ate plan am5dm5t ,! t]m ,,sud-focus$ ,/ate plan am5dm5t means a ,/ate plan am5dm5t "u ?is section t is design$ to provide heal? home s]vices prim>ily to ,,sud-eligible individuals4 4 7b7 ,requirem5t = ,/ate ,m$icaid plans to provide cov]age = m$ication-assi/$ treatm5t 7#a7 ,requirem5t = ,/ate ,m$icaid plans to provide cov]age = m$ication-assi/$ treatm5t ,section #aijb7;a77#aj77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#aj77;,a77 is am5d$1 9 ! matt] prec$+ clause 7i71 by /rik+ & 7#bh7 & ins]t+ 7#bh71 & 7#bi74 7#b7 ,inclusion ( m$ication-assi/$ treatm5t z m$ical assi/ance ,section #aije7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7a77 is am5d$-- 7,a7 9 p>agraph 7#bh71 by /rik+ & at ! end2 7,b7 by r$esignat+ p>agraph 7#bi7 z p>agraph 7#cj72 & 7,c7 by ins]t+ aft] p>agraph 7#bh7 ! foll[+ new p>agraph3 7#bi7 subject to p>agraph 7#b7 ( subsection 7ee71 = ! p]iod beg9n+ ,octob] #a1 #bjbj1 & end+ ,septemb] #cj1 #bjbe1 m$ication-assi/$ treatm5t 7z def9$ 9 p>agraph 7#a7 ( su* subsection72 & 4 7#c7 ,m$ication-assi/$ treatm5t def9$2 ,waiv]s ,section #aije ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7ee7 ,m$ication-assi/$ treatm5t 7#a7 ,def9ition ,= purposes ( subsection 7a77#bi71 ! t]m m$ication-assi/$ treatm5t-- 7,a7 means all drugs approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 includ+ me?adone1 & all biological products lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 to treat opioid use disord]s2 & 7,b7 includes1 ) respect to ! provision ( su* drugs & biological products1 c\nsel+ s]vices & behavioral !rapy4 7#b7 ,exception ,! provisions ( p>agraph 7#bi7 ( subsection 7a7 %all n apply ) respect to a ,/ate = ! p]iod specifi$ 9 su* p>agraph1 if be=e ! beg9n+ ( su* p]iod ! ,/ate c]tifies to ! satisfaction ( ! ,secret>y t implem5t+ su* provisions /atewide = all individuals eligible to enroll 9 ! ,/ate plan 7or waiv] ( ! ,/ate plan7 w\ld n be feasible by reason ( a %ortage ( qualifi$ provid]s ( m$ication-assi/$ treatm5t1 or facilities provid+ su* treatm5t1 t w contract ) ! ,/ate or a manag$ c>e entity ) :i* ! ,/ate has a contract "u section #aijc7m7 or "u section #aije7t77#c74 4 7#d7 ,effective date 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 ! am5dm5ts made by ?is subsection %all apply ) respect to m$ical assi/ance provid$ on or aft] ,octob] #a1 #bjbj1 & be=e ,octob] #a1 #bjbe4 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 subsection1 ! 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 ,,ii ,m$ic>e ,provisions to ,address ! ,opioid ,crisis #bjja4 ,au?ority n to apply c]ta9 ,m$ic>e teleheal? requirem5ts 9 ! case ( c]ta9 treatm5t ( a sub/ance use disord] or co-occurr+ m5tal heal? disord] ,section #ahcd7m7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77 is am5d$-- 7#a7 9 p>agraph 7#b77;,b77i71 by ins]t+ & p>agraph 7#g77;,e7 aft] ,subject to clause 7ii72 & 7#b7 by add+ at ! end ! foll[+ new p>agraphs3 7#g7 ,au?ority n to apply c]ta9 requirem5ts 9 ! case ( c]ta9 treatm5t ( sub/ance use disord] or co-occurr+ m5tal heal? disord] 7,a7 ,9 g5]al ,= purposes ( paym5t "u ?is subsection1 9 ! case ( teleheal? s]vices describ$ 9 subp>agraph 7,c7 furni%$ on or aft] ,janu>y #a1 #bjbj1 to an eligible b5efici>y 7z def9$ 9 subp>agraph 7,f77 = ! treatm5t ( a sub/ance use disord] or a m5tal heal? disord] t is co-occurr+ ) a sub/ance use disord]1 ! ,secret>y is au?oriz$ to1 ?r\gh rulemak+1 n apply any ( ! requirem5ts describ$ 9 subp>agraph 7,b74 7,b7 ,requirem5ts describ$ ,= purposes ( ?is p>agraph1 ! requirem5ts describ$ 9 ?is subp>agraph are any ( ! foll[+3 7i7 ,qualifications = an orig9at+ site "u p>agraph 7#d77;,c77ii74 7ii7 ,geographic limitations "u p>agraph 7#d77;,c77i74 7,c7 ,teleheal? s]vices describ$ ,= purposes ( ?is p>agraph1 ! teleheal? s]vices describ$ 9 ?is subp>agraph are s]vices t are bo? teleheal? s]vices 7z describ$ 9 p>agraph 7#d77;,f77 & id5tifi$ by ! ,secret>y1 ?r\gh rulemak+1 z s]vices t are ! mo/ commonly furni%$ 7z def9$ by ! ,secret>y7 "u ?is "p to individuals diagnos$ ) a sub/ance use disord] or a m5tal heal? disord] t is co-occurr+ ) a sub/ance use disord]4 7,d7 ,cl>ification ,no?+ 9 ?is p>agraph %all be con/ru$ z limit+ or o!rwise affect+ ! au?ority ( ! ,secret>y to limit or elim9ate ! non-application pursuant to ?is p>agraph ( any ( ! requirem5ts "u subp>agraph 7,b74 7,e7 ,treatm5t ( orig9at+ site facility fee ,no facility fee %all be paid "u p>agraph 7#b77;,b7 to an orig9at+ site ) respect to a teleheal? s]vice describ$ 9 subp>agraph 7,b7 = :i* paym5t is made "u ?is subsection by reason ( ! non-application ( a requirem5t describ$ 9 subp>agraph 7,b7 pursuant to ?is p>agraph if paym5t = su* s]vice w\ld n o!rwise be p]mitt$ "u ?is subsection if su* requirem5t 7 appli$4 7,f7 ,eligible b5efici>y def9$ ,= purposes ( ?is p>agraph1 ! t]m eligible b5efici>y means an individual :o-- 7i7 is entitl$ to1 or enroll$ =1 b5efits "u "p ,a & enroll$ = b5efits "u ?is "p2 7ii7 has a diagnosis = a sub/ance use disord]2 & 7iii7 meets su* o!r crit]ia z ! ,secret>y det]m9es appropriate4 7,g7 ,report ,n lat] ?an #e ye>s aft] ! date ( ! enactm5t ( ?is p>agraph1 ! ,secret>y %all submit to ,congress a report on ! impact ( any non-application "u ?is p>agraph ( any ( ! requirem5ts describ$ 9 subp>agraph 7,b7 on 7i7 ! utilization ( heal? c>e s]vices relat$ to sub/ance use disord]1 su* z behavioral heal? s]vices & em]g5cy dep>tm5t visits2 & 7ii7 heal? outcomes relat$ to sub/ance use disord]1 su* z sub/ance use ov]dose dea?s4 7,h7 ,fund+ ,= purposes ( c>ry+ out ?is p>agraph1 9 addition to funds o!rwise available1 ! ,secret>y %all provide = ! transf]1 f ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund "u section #ahda1 ( #c1jjj1jjj to ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices ,program ,managem5t ,acc\nt to rema9 available until exp5d$4 7#h7 ,rule ( con/ruction ,no?+ 9 ?is subsection may be con/ru$ z waiv+ requirem5ts "u ?is title to comply ) applicable ,/ate law1 includ+ ,/ate lic5sure requirem5ts4 4 #bjjb4 ,enc\rag+ ! use ( non-opioid analgesics = ! managem5t ( po/-surgical pa9 ,section #ahcc7t77#f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#f77 is am5d$-- 7#a7 9 subp>agraph 7,c77i71 by ins]t+ or1 9 ! case ( an eligible non-opioid analgesic 7z def9$ 9 subp>agraph 7,j771 dur+ a p]iod ( #e ye>s1 aft] #c ye>s12 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,j7 ,eligible non-opioid analgesic def9$ ,9 ?is p>agraph1 ! t]m eligible non-opioid analgesic means a drug or biological-- 7i7 t is an analgesic t is n an opioid2 7ii7 t demon/rat$ sub/antial cl9ical improvem5t1 z det]m9$ by ! ,secret>y2 & 7iii7 = :i* paym5t-- 7,i7 z an outpati5t hospital s]vice "u ?is "p 0 n be+ made z ( ! date ( ! enactm5t ( ?is subp>agraph2 or 7,,ii7 0 be+ made "u ?is p>agraph z ( su* date4 4 #bjjc4 ,requir+ a review ( curr5t opioid prescriptions = *ronic pa9 & scre5+ = opioid use disord] to be includ$ 9 ! ,welcome to ,m$ic>e initial prev5tive physical exam9ation 7a7 ,9 g5]al ,section #ahfa7ww7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7ww77 is am5d$-- 7#a7 9 p>agraph 7#a71 by ins]t+ & a review ( curr5t opioid prescriptions & scre5+ = opioid use disord] 7z def9$ 9 p>agraph 7#d771 be=e b does n include2 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#d7 7,a7 ,= purposes ( p>agraph 7#a71 ! t]m a review ( curr5t opioid prescriptions & scre5+ = opioid use disord] means1 ) respect to an individual-- 7i7 a review by a physician or qualifi$ non-physician practition] ( all curr5t prescriptions ( ! individual2 & 7ii7 9 ! case ( an individual det]m9$ by ! review ( a physician or qualifi$ non-physician practition] "u subp>agraph 7,a7 to h a curr5t prescription = opioids = *ronic pa9 t has be5 prescrib$ = a m9imum p]iod ( "t 7z specifi$ by ! ,secret>y7-- 7,i7 a review by ! physician or practition] ( ! pot5tial risk factors to ! individual = opioid use disord]2 7,,ii7 an evaluation by ! physician or practition] ( pa9 ( ! individual2 7,,iii7 ! provision ( in=mation reg>d+ non-opioid treatm5t options = ! treatm5t & managem5t ( any *ronic pa9 ( ! individual2 & 7,,iv7 if det]m9$ necess>y by ! physician or practition] bas$ on ! results ( ! review & evaluation conduct$ z describ$ 9 ?is p>agraph1 an appropriate ref]ral by ! physician or practition] = additional treatm5t4 7,b7 ,= purposes ( ?is p>agraph1 ! t]m qualifi$ non-physician practition] means a physician assi/ant1 nurse practition]1 or cl9ical nurse speciali/4 4 7b7 ,cl>ification ,no?+ 9 ! am5dm5ts made by subsection 7a7 %all be con/ru$ to prohibit sep>ate paym5t = /ructur$ assessm5t & int]v5tion s]vices = sub/ance abuse furni%$ to an individual on ! same day z an initial prev5tive physical exam9ation4 7c7 ,effective date ,! am5dm5ts made by subsection 7a7 %all apply ) respect to initial prev5tive physical exam9ations furni%$ on or aft] ,janu>y #a1 #bjbj4 #bjjd4 ,modification ( paym5t = c]ta9 outpati5t surgical s]vices 7a7 ,freeze ( paym5t = c]ta9 s]vices furni%$ 9 ambulatory surgical c5t]s ,section #ahcc7;i77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7i77#b77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,f7 7i7 ,) respect to a t>get$ proc$ure 7z def9$ 9 clause 7ii77 furni%$ dur+ #bjbj or a subsequ5t ye> 7be=e #bjbd7 to an individual 9 an ambulatory surgical c5t]1 ! paym5t am\nt = su* proc$ure t w\ld o!rwise be det]m9$ "u ! revis$ paym5t sy/em "u subp>agraph 7,d71 )\t application ( ?is subp>agraph1 %all be equal to ! paym5t am\nt = su* proc$ure furni%$ 9 #bjaf4 7ii7 ,= purposes ( clause 7i71 ! t]m t>get$ proc$ure means a proc$ure to :i* ,heal?c>e ,common ,proc$ure ,cod+ ,sy/em code #fbcaj 7or1 = ye>s beg9n+ aft] #bjaf1 #fbcba71 #fbcaa 7or1 = ye>s beg9n+ aft] #bjaf1 #fbcbc71 #fbbfd1 #fddij1 #fddic1 or ,g#jbfj1 or any successor code1 apply4 7iii7 ,?is subp>agraph %all n be appli$ 9 a budget-neutral mann]4 4 7b7 ,data collection 7#a7 ,9 g5]al ,! ,comptroll] ,g5]al %all collect data relat+ to ! co/ diff]5tial betwe5 t>get$ proc$ures 7z def9$ 9 section #ahcc7;i77#b77;,f77ii7 ( ! ,social ,security ,act1 z add$ by subsection 7a77 t are p]=m$ 9 a hospital op]at+ room & su* proc$ures t are p]=m$ 9 an (fice sett+ )9 a hospital 9 ord] to det]m9e :e!r su* proc$ures are be+ prop]ly cod$ = claims1 bas$ on sett+1 = paym5t "u section #ahcc7;i77#b77;,d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7i77#b77;,d77 & to det]m9e if fur!r *anges are ne$$ 9 ! classification sy/em = cov]$ outpati5t dep>tm5t s]vices 7z describ$ 9 section #ahcc7t77#b77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#b77;,a774 7#b7 ,report ,n lat] ?an #d ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al %all submit a report to ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,ways & ,means ( ! ,h\se ( ,repres5tatives & ! ,committee on ,f9ance ( ! ,s5ate conta9+-- 7,a7 a det]m9ation ( :e!r proc$ures describ$ 9 p>agraph 7#a7 are be+ prop]ly cod$ = claims1 bas$ on sett+1 = paym5t "u section #ahcc7;i77#b77;,d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7i77#b77;,d772 & 7,b7 recomm5dations on any *anges ! ,comptroll] ,g5]al det]m9es are ne$$ 9 ! classification sy/em = cov]$ outpati5t dep>tm5t s]vices 7z describ$ 9 section #ahcc7t77#b77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#b77;,a774 7c7 ,/udy ,n lat] ?an #c ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all conduct a /udy & submit to ,congress a report on ! ext5t to :i* proc$ures describ$ 9 section #ahcc7;i77#b77;,f77ii7 ( ! ,social ,security ,act1 z add$ by subsection 7a71 are effective at prev5t+ ! ne$ = opioids = individuals furni%$ su* proc$ures4 #bjje4 ,requir+ e-prescrib+ = cov]age ( cov]$ "p ,d controll$ sub/ances 7a7 ,9 g5]al ,section #ahfj;,d-#d7;e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;e77 is am5d$ by add+ at ! end ! foll[+3 7#g7 ,requirem5t ( e-prescrib+ = controll$ sub/ances 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 a prescription = a cov]$ "p ,d drug "u a prescription drug plan 7or "u an ,,ma-,,pd plan7 = a s*$ule ,,ii1 ,,iii1 ,,iv1 or ,v controll$ sub/ance %all be transmitt$ by a heal? c>e practition] electronically 9 accordance ) an electronic prescription drug program t meets ! requirem5ts ( p>agraph 7#b74 7,b7 ,exception = c]ta9 circum/ances ,! ,secret>y %all1 pursuant to rulemak+1 specify circum/ances ) respect to :i* ! ,secret>y may waive ! requirem5t "u subp>agraph 7,a71 ) respect to a cov]$ "p ,d drug1 includ+ 9 ! case (-- 7i7 a prescription issu$ :5 ! practition] & disp5s] are ! same entity2 7ii7 a prescription issu$ t _c be transmitt$ electronically "u ! mo/ rec5tly implem5t$ v]sion ( ! ,national ,c\ncil = ,prescription ,drug ,programs ,,script ,/&>d2 7iii7 a prescription issu$ by a practition] :o has receiv$ a waiv] or a r5ewal !re( = a specifi$ p]iod det]m9$ by ! ,secret>y1 n to exce$ #a ye>1 f ! requirem5t to use electronic prescrib+1 pursuant to a process e/abli%$ by regulation by ! ,secret>y1 due to demon/rat$ economic h>d%ip1 te*nological limitations t are n reasonably )9 ! control ( ! practition]1 or o!r exceptional circum/ance demon/rat$ by ! practition]2 7iv7 a prescription issu$ by a practition] "u circum/ances 9 :i*1 not)/&+ ! practition]'s ability to submit a prescription electronically z requir$ by ?is subsection1 su* practition] reasonably det]m9es t x w\ld be impractical = ! individual involv$ to obta9 sub/ances prescrib$ by electronic prescription 9 a timely mann]1 & su* delay w\ld adv]sely impact ! individual's m$ical condition involv$2 7v7 a prescription issu$ by a practition] all[+ = ! disp5s+ ( a non-pati5t specific prescription pursuant to a /&+ ord]1 approv$ protocol = drug !rapy1 collaborative drug managem5t1 or compreh5sive m$ication managem5t1 9 response to a public heal? em]g5cy1 or o!r circum/ances :]e ! practition] may issue a non-pati5t specific prescription2 7vi7 a prescription issu$ by a practition] prescrib+ a drug "u a rese>* protocol2 7vii7 a prescription issu$ by a practition] = a drug = :i* ! ,food & ,drug ,adm9i/ration requires a prescription to conta9 elem5ts t are n able to be includ$ 9 electronic prescrib+1 su* z a drug ) risk evaluation & mitigation /rategies t include elem5ts to assure safe use2 & 7viii7 a prescription issu$ by a practition] = an individual :o-- 7,i7 receives hospice c>e "u ?is title2 or 7,,ii7 is a resid5t ( a skill$ nurs+ facility 7z def9$ 9 section #ahai7;a771 or a m$ical in/itution or nurs+ facility = :i* paym5t is made = an in/itutionaliz$ individual "u section #aijb7q77#a77;,b71 = :i* frequ5tly abus$ drugs are disp5s$ = resid5ts ?r\gh a contract ) a s+le ph>macy1 z det]m9$ by ! ,secret>y 9 accordance ) ?is p>agraph4 7,c7 ,disp5s+ ,no?+ 9 ?is p>agraph %all be con/ru$ z requir+ a sponsor ( a prescription drug plan "u ?is "p1 ,,ma organization (f]+ an ,,ma-,,pd plan "u "p ,c1 or a ph>maci/ to v]ify t a practition]1 ) respect to a prescription = a cov]$ "p ,d drug1 has a waiv] 7or is o!rwise exempt7 "u subp>agraph 7,b7 f ! requirem5t "u subp>agraph 7,a74 ,no?+ 9 ?is p>agraph %all be con/ru$ z affect+ ! ability ( ! plan to cov] or ! ph>maci/s' ability to cont9ue to disp5se cov]$ "p ,d drugs f o!rwise valid writt51 oral or fax prescriptions t are consi/5t ) laws & regulations4 ,no?+ 9 ?is p>agraph %all be con/ru$ z affect+ ! ability ( ! b5efici>y involv$ to designate a p>ticul> ph>macy to disp5se a prescrib$ drug to ! ext5t consi/5t ) ! requirem5ts "u subsection 7b77#a7 & "u ?is p>agraph4 7,d7 ,en=cem5t ,! ,secret>y %all1 pursuant to rulemak+1 h au?ority to en=ce & specify appropriate p5alties = non-compliance ) ! requirem5t "u subp>agraph 7,a74 4 7b7 ,effective date ,! am5dm5t made by subsection 7a7 %all apply to cov]age ( drugs prescrib$ on or aft] ,janu>y #a1 #bjba4 #bjjf4 ,requir+ prescription drug plan sponsors "u ,m$ic>e to e/abli% drug managem5t programs = at-risk b5efici>ies ,section #ahfj;,d-#d7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c77 is am5d$-- 7#a7 9 p>agraph 7#a71 by ins]t+ aft] subp>agraph 7,e7 ! foll[+ new subp>agraph3 7,f7 ,) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjba1 a drug managem5t program = at-risk b5efici>ies describ$ 9 p>agraph 7#e74 2 & 7#b7 9 p>agraph 7#e77;,a71 by ins]t+ 7& = plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjba1 a ,,pdp sponsor %all7 aft] ,a ,,pdp sponsor may4 #bjjg4 ,m$ic>e cov]age ( c]ta9 s]vices furni%$ by opioid treatm5t programs 7a7 ,cov]age ,section #ahfa7s77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#b77 is am5d$-- 7#a7 9 subp>agraph 7,,ff71 by /rik+ at ! end &2 7#b7 9 subp>agraph 7,,gg71 by ins]t+ at ! end 2 &2 & 7#c7 by add+ at ! end ! foll[+ new subp>agraph3 7,,hh7 opioid use disord] treatm5t s]vices 7z def9$ 9 subsection 7jjj774 4 7b7 ,opioid use disord] treatm5t s]vices & opioid treatm5t program def9$ ,section #ahfa ( ! ,social ,security ,act is am5d$ by add+ at ! end ! foll[+ new subsection3 7jjj7 ,opioid use disord] treatm5t s]vices2 opioid treatm5t program 7#a7 ,opioid use disord] treatm5t s]vices ,! t]m opioid use disord] treatm5t s]vices means items & s]vices t are furni%$ by an opioid treatm5t program = ! treatm5t ( opioid use disord]1 includ+-- 7,a7 opioid agoni/ & antagoni/ treatm5t m$ications 7includ+ oral1 inject$1 or implant$ v]sions7 t are approv$ by ! ,food & ,drug ,adm9i/ration "u section #eje ( ! ,f$]al ,food1 ,drug & ,cosmetic ,act = use 9 ! treatm5t ( opioid use disord]2 7,b7 disp5s+ & adm9i/ration ( su* m$ications1 if applicable2 7,c7 sub/ance use c\nsel+ by a pr(essional to ! ext5t au?oriz$ "u ,/ate law to furni% su* s]vices2 7,d7 individual & gr\p !rapy ) a physician or psy*ologi/ 7or o!r m5tal heal? pr(essional to ! ext5t au?oriz$ "u ,/ate law72 7,e7 toxicology te/+1 & 7,f7 o!r items & s]vices t ! ,secret>y det]m9es are appropriate 7b 9 no ev5t to include meals or transportation74 7#b7 ,opioid treatm5t program ,! t]m opioid treatm5t program means an entity t is opioid treatm5t program 7z def9$ 9 section #h4b ( title #db ( ! ,code ( ,f$]al ,regulations1 or any successor regulation7 t-- 7,a7 is enroll$ "u section #ahff7;j72 7,b7 has 9 effect a c]tification by ! ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration = su* a program2 7,c7 is accr$it$ by an accr$it+ body approv$ by ! ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration2 & 7,d7 meets su* additional conditions z ! ,secret>y may f9d necess>y to ensure-- 7i7 ! heal? & safety ( individuals be+ furni%$ s]vices "u su* program2 & 7ii7 ! effective & effici5t furni%+ ( su* s]vices4 4 7c7 ,paym5t 7#a7 ,9 g5]al ,section #ahcc7;a77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77#a77 is am5d$-- 7,a7 by /rik+ & 7,,bb7 & ins]t+ 7,,bb72 & 7,b7 by ins]t+ be=e ! semicolon at ! end ! foll[+ 1 & 7,,cc7 ) respect to opioid use disord] treatm5t s]vices furni%$ dur+ an episode ( c>e1 ! am\nt paid %all be equal to ! am\nt payable "u section #ahcd7w7 less any copaym5t requir$ z specifi$ by ! ,secret>y4 7#b7 ,paym5t det]m9ation ,section #ahcd ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7w7 ,opioid use disord] treatm5t s]vices 7#a7 ,9 g5]al ,! ,secret>y %all pay to an opioid treatm5t program 7z def9$ 9 p>agraph 7#b7 ( section #ahfa7;jjj77 an am\nt t is equal to #ajj p]c5t ( a bundl$ paym5t "u ?is "p = opioid use disord] treatm5t s]vices 7z def9$ 9 p>agraph 7#a7 ( su* section7 t are furni%$ by su* program to an individual dur+ an episode ( c>e 7z def9$ by ! ,secret>y7 beg9n+ on or aft] ,janu>y #a1 #bjbj4 ,! ,secret>y %all ensure1 z det]m9$ appropriate by ! ,secret>y1 t no duplicative paym5ts are made "u ?is "p or "p ,d = items & s]vices furni%$ by an opioid treatm5t program4 7#b7 ,consid]ations ,! ,secret>y may implem5t ?is subsection ?r\gh "o or m bundles bas$ on ! type ( m$ication provid$ 7su* z bupr5orph9e1 me?adone1 naltrexone1 or a new innovative drug71 ! frequ5cy ( s]vices1 ! scope ( s]vices furni%$1 *>act]i/ics ( ! individuals furni%$ su* s]vices1 or o!r factors z ! ,secret>y det]m9e appropriate4 ,9 develop+ su* bundles1 ! ,secret>y may consid] paym5t rates paid to opioid treatm5t programs = comp>able s]vices "u ,/ate plans "u title ,,xix or "u ! ,,tric>e program "u *apt] #ee ( title #aj ( ! ,unit$ ,/ates ,code4 7#c7 ,annual updates ,! ,secret>y %all provide an update ea* ye> to ! bundl$ paym5t am\nts "u ?is subsection4 4 7d7 ,includ+ opioid treatm5t programs z ,m$ic>e provid]s ,section #ahff7;e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;cc7e77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ at ! end &2 7#b7 9 p>agraph 7#b71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+ new p>agraph3 7#c7 opioid treatm5t programs 7z def9$ 9 p>agraph 7#b7 ( section #ahfa7;jjj771 b only ) respect to ! furni%+ ( opioid use disord] treatm5t s]vices 7z def9$ 9 p>agraph 7#a7 ( su* section74 4 ,,iii ,o!r ,heal? ,provisions to ,address ! ,opioid ,crisis #cjja4 ,cl>ify+ ,,fda regulation ( non-addictive pa9 & addiction !rapies 7a7 ,public meet+s ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all hold n less ?an "o public meet+ to address ! *all5ges & b>ri]s ( develop+ non-addictive m$ical products int5d$ to treat pa9 or addiction1 :i* may include-- 7#a7 ! application ( novel cl9ical trial designs 7consi/5t ) section #cjba ( ! #ba/ ,c5tury ,cures ,act 7,public ,law #aad-bee771 use ( real _w evid5ce 7consi/5t ) section #eje;,f ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;g771 & use ( pati5t exp]i5ce data 7consi/5t ) section #efi;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;c77 = ! developm5t ( non-addictive m$ical products int5d$ to treat pa9 or addiction2 & 7#b7 ! application ( eligibility crit]ia "u sections #ejf & #eae;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef1 #cfj;e-#c7 = non-addictive m$ical products int5d$ to treat pa9 or addiction4 7b7 ,guidance ,n lat] ?an #a ye> aft] ! public meet+s are conduct$ "u subsection 7a7 ! ,secret>y %all issue "o or m f9al guidance docum5ts1 or update exi/+ guidance docum5ts1 to help address *all5ges to develop+ non-addictive m$ical products to treat pa9 or addiction4 ,su* guidance docum5ts %all include in=mation reg>d+-- 7#a7 h[ ! ,food & ,drug ,adm9i/ration may apply sections #ejf & #eae;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef1 #cfj;e-#c7 to non-addictive m$ical products int5d$ to treat pa9 or addiction1 includ+ ! circum/ances "u :i* ! ,secret>y-- 7,a7 may apply ! eligibility crit]ia "u su* sections #ejf & #eae;,b to non-opioid or non-addictive m$ical products int5d$ to treat pa9 or addiction2 7,b7 consid]s ! risk ( addiction ( controll$ sub/ances approv$ to treat pa9 :5 e/abli%+ unmet m$ical ne$2 & 7,c7 consid]s pa91 pa9 control1 or pa9 managem5t 9 assess+ :e!r a disease or condition is a s]i\s or life-?reat5+ disease or condition2 & 7#b7 ! me?ods by :i* sponsors may evaluate acute & *ronic pa91 endpo9ts = non-addictive m$ical products int5d$ to treat pa91 ! mann] 9 :i* endpo9ts & evaluations ( efficacy w be appli$ across & )9 review divisions1 tak+ into consid]ation ! etiology ( ! und]ly+ disease1 & ! mann] 9 :i* sponsors may use surrogate endpo9ts1 int]m$iate endpo9ts1 & real _w evid5ce4 7c7 ,m$ical product def9$ ,9 ?is section1 ! t]m m$ical product means a drug 7z def9$ 9 section #bja7;g77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g77#a7771 biological product 7z def9$ 9 section #cea7;i7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;i7771 or device 7z def9$ 9 section #bja7;h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;h7774 #cjjb4 ,surveillance & ,te/+ ( ,opioids to ,prev5t ,f5tanyl ,dea?s 7a7 ,public heal? laboratories to detect f5tanyl ,"p ,f ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb et seq47 is am5d$-- 7#a7 9 ! head+ ( "p ,f1 by /rik+ & cl9ical laboratories & ins]t+ 1 cl9ical laboratories1 & public heal? laboratories2 & 7#b7 by add+ at ! end ! foll[+ new subp>t3 #d ,public ,heal? ,laboratories #cee4 ,public heal? laboratories to detect f5tanyl 7a7 ,9 g5]al ,! ,secret>y %all e/abli% a program to aw>d grants to ,f$]al1 ,/ate1 & local ag5cies to support ! e/abli%m5t or op]ation ( public heal? laboratories to detect f5tanyl1 its analogues1 & o!r syn!tic opioids1 z describ$ 9 subsection 7b74 7b7 ,/&>ds ,! ,secret>y1 9 consultation ) ! ,director ( ! ,national ,in/itute ( ,/&>ds & ,te*nology1 %all-- 7#a7 develop /&>ds = safely & effectively h&l+ & te/+ f5tanyl1 its analogues1 & o!r syn!tic opioids2 7#b7 develop f5tanyl & f5tanyl analog ref]5ce mat]ials & quality control /&>ds & protocols to calibrate in/rum5tation = cl9ical diagno/ics & po/mortem surveillance2 & 7#c7 include 9 ! /&>ds develop$ pursuant to p>agraph 7#a7 proc$ures = enc\nt]+ new & em]g+ syn!tic opioid =mulations & report+ ^? f9d+s to o!r ,f$]al1 ,/ate1 & local public heal? laboratories4 7c7 ,laboratories ,! ,secret>y %all require grantees "u subsection 7a7 to-- 7#a7 foll[ ! /&>ds e/abli%$ "u subsection 7b7 & be capable ( provid+ sy/ematic & r\t9e laboratory te/+ ( drugs = ! purposes ( obta9+ & dissem9at+ public heal? in=mation to ,f$]al1 ,/ate1 & local public heal? (ficials1 laboratories1 & o!r entities ! ,secret>y deems appropriate2 7#b7 "w ) law en=cem5t ag5cies & public heal? au?orities1 z feasible1 to develop real-"t in=mation on ! purity & movem5t ( f5tanyl1 its analogues1 & o!r syn!tic opioids2 7#c7 assi/ ,/ate & local law en=cem5t ag5cies 9 te/+ seiz$ drugs :5 ,/ate & local =5sic laboratories reque/ additional assi/ance2 7#d7 provide e>ly w>n+ in=mation & advice to ,f$]al1 ,/ate1 & local law en=cem5t ag5cies & public heal? au?orities reg>d+ pot5tial significant *anges 9 ! supply ( f5tanyl1 its analogues1 & o!r syn!tic opioids2 7#e7 provide biosurveillance = non-fatal exposures2 & 7#f7 provide diagno/ic te/+ = non-fatal exposures ( em]g5cy p]sonnel4 7d7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re is au?oriz$ to be appropriat$ #ae1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc4 4 7b7 ,enhanc$ f5tanyl surveillance ,title ,,iii ( ! ,public ,heal? ,s]vice ,act is am5d$ by ins]t+ aft] section #cag,t ( su* ,act 7#db ,u4,s4,c4 #bdg;b-#bb7 ! foll[+ new section3 #cag,u4 ,enhanc$ f5tanyl surveillance 7a7 ,9 g5]al ,! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion %all enhance its drug surveillance program by-- 7#a7 exp&+ its surveillance program to include all #ej ,/ates & ! t]ritories ( ! ,unit$ ,/ates2 7#b7 increas+ & accel]at+ ! collection ( data on f5tanyl1 its analogues1 & o!r syn!tic opioids & new em]g+ drugs ( abuse1 includ+ relat$ ov]dose data f m$ical exam9]s & drug treatm5t admissions2 & 7#c7 utiliz+ available & em]g+ in=mation on f5tanyl1 its analogues1 & o!r syn!tic opioids & new em]g+ drugs ( abuse1 includ+ in=mation f-- 7,a7 ! ,national ,drug ,e>ly ,w>n+ ,sy/em2 7,b7 ,/ate & local public heal? au?orities2 & 7,c7 ,f$]al1 ,/ate1 & local public heal? laboratories4 7b7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re is au?oriz$ to be appropriat$ #aj1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc4 4 7c7 ,pilot program = po9t-(-,use te/+ ( illicit drugs = dang]\s contam9ants ,"p ,p ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is am5d$ by add+ at ! end ! foll[+ new section3 #cii,v-#g4 ,pilot program = po9t-(-,use te/+ ( illicit drugs = dang]\s contam9ants 7a7 ,9 g5]al ,! ,secret>y %all-- 7#a7 e/abli% a pilot program ?r\gh :i* #e ,/ate or local ag5cies conduct1 9 #e ,/ates1 po9t-(-use te/+ ( illicit drugs = dang]\s contam9ants2 7#b7 e/abli% metrics to evaluate ! success ( ! pilot program 9 r$uc+ drug ov]dose rates2 & 7#c7 bas$ on su* metrics1 conduct an annual evaluation ( ! pilot program & submit an annual report to ! ,congress conta9+ ! results ( su* evaluation4 7b7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re is au?oriz$ to be appropriat$ #e1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc4 4 #cjjc4 ,all[+ = m flexibility ) respect to m$ication-assi/$ treatm5t = opioid use disord]s 7a7 ,con=m+ applicable numb] ,subclause 7,,ii7 ( section #cjc7;g77#b77;,b77iii7 ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbc7;g77#b77;,b77iii77 is am5d$ to read z foll[s3 7,,ii7 ,! applicable numb] is-- 7aa7 #ajj if1 n soon] ?an #a ye> aft] ! date on :i* ! practition] submitt$ ! initial notification1 ! practition] submits a second notification to ! ,secret>y ( ! ne$ & int5t ( ! practition] to treat up to #ajj pati5ts2 7bb7 #ajj if ! practition] holds additional cr$5tial+1 z def9$ 9 section #h4b ( title #db1 ,code ( ,f$]al ,regulations 7or successor regulations72 or 7cc7 #ajj if ! practition] provides m$ication-assi/$ treatm5t 7,,mat7 us+ cov]$ m$ications 7z su* t]ms are def9$ 9 section #h4b ( title #db1 ,code ( ,f$]al ,regulations 7or successor regulations77 9 a qualifi$ practice sett+ 7z describ$ 9 section #h4fae ( title #db1 ,code ( ,f$]al ,regulations 7or successor regulations774 4 7b7 ,elim9at+ any "t limitation = nurse practition]s & physician assi/ants ,to become qualify+ practition]s ,clause 7iii7 ( section #cjc7;g77#b77;,g7 ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbc7;g77#b77;,g77 is am5d$-- 7#a7 9 subclause 7,i71 by /rik+ or at ! end2 & 7#b7 by am5d+ subclause 7,,ii7 to read z foll[s3 7,,ii7 a qualify+ o!r practition]1 z def9$ 9 clause 7iv71 :o is a nurse practition] or physician assi/ant2 or 4 7c7 ,impos+ a "t limitation = cl9ical nurse speciali/s1 c]tifi$ regi/]$ nurse ane/heti/s1 & c]tifi$ nurse midwifes ,to become qualify+ practition]s ,clause 7iii7 ( section #cjc7;g77#b77;,g7 ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbc7;g77#b77;,g771 z am5d$ by subsection 7b71 is fur!r am5d$ by add+ at ! end ! foll[+3 7,,iii7 = ! p]iod beg9n+ on ,octob] #a1 #bjah1 & end+ on ,octob] #a1 #bjbc1 a qualify+ o!r practition]1 z def9$ 9 clause 7iv71 :o is a cl9ical nurse speciali/1 c]tifi$ regi/]$ nurse ane/heti/1 or c]tifi$ nurse midwife4 4 7d7 ,def9ition ( qualify+ o!r practition] ,section #cjc7;g77#b77;,g77iv7 ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbc7;g77#b77;,g77iv77 is am5d$ by /rik+ nurse practition] or physician assi/ant ea* place x appe>s & ins]t+ nurse practition]1 cl9ical nurse speciali/1 c]tifi$ regi/]$ nurse ane/heti/1 c]tifi$ nurse midwife1 or physician assi/ant4 7e7 ,report by ,secret>y ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 9 consultation ) ! ,drug ,en=cem5t ,adm9i/ration1 %all submit to ,congress a report t assesses ! c>e provid$ by qualify+ practition]s 7z def9$ 9 section #cjc7;g77#b77;,g77iii7 ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbc7;g77#b77;,g77iii777 :o are treat+1 9 ! case ( physicians1 m ?an #ajj pati5ts1 & 9 ! case ( qualify+ practition]s :o are n physicians1 m ?an #cj pati5ts4 ,su* report %all include recomm5dations on future applicable pati5t numb] levels & limits4 ,9 prep>+ su* report1 ! ,secret>y %all /udy1 ) respect to opioid use disord] treatm5t-- 7#a7 ! av]age frequ5cy ) :i* qualify+ practition]s see _! pati5ts2 7#b7 ! av]age frequ5cy ) :i* pati5ts receive c\nsel+1 includ+ ! rates by :i* su* c\nsel+ is provid$ by su* a qualify+ practition] directly1 or by ref]ral2 7#c7 ! frequ5cy ( toxicology te/+1 includ+ ! av]age frequ5cy ) :i* r&om toxicology te/+ is adm9i/]$2 7#d7 ! av]age mon?ly pati5t caseload = ea* type ( qualify+ practition]2 7#e7 ! treatm5t ret5tion rates = pati5ts2 7#f7 ov]dose & mortality rates2 & 7#g7 any available in=mation reg>d+ ! div]sion ( drugs by pati5ts receiv+ su* treatm5t f su* a qualify+ practition]4 #cjjd4 ,high-quality1 evid5ce-bas$ opioid analgesic prescrib+ guidel9es & report 7a7 ,guidel9es ,! ,commission] ( ,food & ,drugs %all develop high-quality1 evid5ce-bas$ opioid analgesic prescrib+ guidel9es = ! indication-specific treatm5t ( acute pa9 9 ! relevant !rapeutic areas :]e su* guidel9es d n exi/4 7b7 ,public input ,9 develop+ ! guidel9es "u subsection 7a71 ! ,commission] ( ,food & ,drugs %all-- 7#a7 conduct a public work%op1 op5 to repres5tatives ( ,/ate m$ical societies & m$ical bo>ds1 v>i\s m$ical specialties includ+ pa9 m$ic9e specialty societies1 pati5t gr\ps1 ph>maci/s1 univ]sities1 & o!rs2 & 7#b7 provide a p]iod = ! submission ( comm5ts by ! public4 7c7 ,report ,n lat] ?an ! date t is #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,commission] ( ,food & ,drugs %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate1 & po/ on ! public website ( ! ,food & ,drug ,adm9i/ration1 a report on h[ ! guidel9es "u subsection 7a7 w be utiliz$ to protect ! public heal?4 7d7 ,updates ,! ,commission] ( ,food & ,drugs %all p]iodically-- 7#a7 update ! guidel9es "u subsection 7a71 in=m$ by public input describ$ 9 subsection 7b72 & 7#b7 submit to ! committees specifi$ 9 subsection 7c7 & po/ on ! public website ( ! ,food & ,drug ,adm9i/ration an updat$ report "u subsection 7c74 7e7 ,/atem5t ,to accompany guidel9es & recomm5dations ,! ,commission] ( ,food & ,drugs %all ensure t any opioid analgesic prescrib+ guidel9es & o!r recomm5dations develop$ "u ?is section are accompani$ by a cle> /atem5t t su* guidel9es or recomm5dations1 z applicable-- 7#a7 are int5d$ to help in=m cl9ical decisionmak+ by prescrib]s & pati5ts2 & 7#b7 %\ld n be us$ by o!r p>ties1 includ+ ph>macy b5efit managem5t companies1 retail or community ph>macies1 or public & private payors1 = ! purposes ( re/rict+1 limit+1 delay+1 or d5y+ cov]age = or access to a prescription issu$ = a legitimate m$ical purpose by an individual practition] act+ 9 ! usual c\rse ( pr(essional practice4 7f7 ,def9ition ,9 ?is section1 ! t]m evid5ce-bas$ means in=m$ by a robu/ & sy/emic review ( treatm5t efficacy & cl9ical evid5ce4 #cjje4 ,report on opioids prescrib+ practices = pregnant wom5 7a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 9 coord9ation ) ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,national ,in/itutes ( ,heal?1 & ! ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration %all develop & submit to ! ,congress a report-- 7#a7 on opioids prescrib+ practices = pregnant wom5 & recomm5dations = su* practices2 7#b7 t provides recomm5dations = id5tify+ & r$uc+ opioids misuse dur+ pregnancy2 7#c7 on prescription opioid misuse dur+ pregnancy 9 urban & rural areas2 7#d7 on prescription opioid use dur+ pregnancy = ! purpose ( m$ication-assi/$ treatm5t 9 urban & rural areas2 7#e7 evaluat+ curr5t utilization ( non-opiate pa9 managem5t practices 9 place ( prescription opioids dur+ pregnancy2 7#f7 provid+ guidel9es enc\rag+ ! use ( non-opioid pa9 managem5t practices dur+ pregnancy :5 safe & effective2 & 7#g7 t provides recomm5dations = increas+ public aw>5ess & education ( opioid use disord] 9 pregnancy1 includ+ available treatm5t res\rces 9 urban & rural areas4 7b7 ,no additional funds ,no additional funds are au?oriz$ to be appropriat$ = purposes ( c>ry+ out subsection 7a74 #cjjf4 ,guidel9es = prescrib+ naloxone 7a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue guidel9es = prescrib+ an opioid ov]dose rev]sal drug4 7b7 ,cont5ts ,9 issu+ guidel9es "u subsection 7a71 ! ,secret>y %all address ! foll[+3 7#a7 ,co-prescrib+ an opioid ov]dose rev]sal drug 9 conjunction ) any prescrib$ opioid4 7#b7 ,dosage safety4 7#c7 ,prescrib+ an opioid ov]dose rev]sal drug to an individual o!r ?an a pati5t4 7#d7 ,/&+ ord]s4 7#e7 ,o!r di/ribution1 education1 & safety measures z det]m9$ necess>y4 #cjjg4 ,requir+ a survey ( sub/ance use disord] treatm5t provid]s receiv+ ,f$]al fund+ 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 %all conduct a survey ( all entities t receive ,f$]al fund+ = ! purpose ( provid+ sub/ance use disord] treatm5t s]vices4 ,! survey %all direct su* entities to provide ! foll[+ in=mation3 7#a7 ,! l5g? ( "t ! entity has provid$ sub/ance use disord] treatm5t s]vices4 7#b7 ,a detail$ description ( ! pati5t population s]v$ by ! entity1 includ+ b n limit$ to ! numb] ( pati5ts1 type ( addictions1 geographic area s]v$1 z well z g5d]1 racial1 e?nic & socioeconomic demographics ( su* pati5ts4 7#c7 ,a detail$ description ( ! types ( addiction = :i* ! entity has ! exp]i5ce1 capability1 & capacity to provide su* s]vices4 7#d7 ,an explanation ( h[ ! entity h&les pati5ts requir+ treatm5t = a sub/ance use disord] t ! organization is n able to treat4 7#e7 ,a description ( :at is ne$$1 9 ! op9ion ( ! entity1 9 ord] to improve ! entity's ability to meet ! addiction treatm5t ne$s ( ! communities s]v$ by t entity4 7#f7 ,bas$ on ! id5tifi$ ne$s ( ! communities s]v$1 a description ( unmet ne$s & inadequate s]vices & h[ su* ne$s & s]vices c\ld be bett] address$ ?r\gh additional ,f$]al1 ,/ate1 or local gov]nm5t res\rces or fund+ to treat addiction to me?amphetam9e1 crack coca9e1 o!r types ( coca9e1 h]o91 opioids1 & o!r commonly abus$ drugs4 7b7 ,report ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y %all develop & submit to ,congress a plan to direct appropriate res\rces to entities t provide sub/ance use disord] treatm5t s]vices 9 ord] to address inadequacies 9 s]vices or fund+ id5tifi$ ?r\gh ! survey describ$ 9 subsection 7a74 ,,iv ,(fsets #djja4 ,promot+ value 9 ,m$icaid manag$ c>e ,section #aijc7m7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7m77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#g7 7,a7 ,) respect to exp5ditures describ$ 9 subp>agraph 7,b7 t are incurr$ by a ,/ate = any fiscal ye> aft] fiscal ye> #bjbj 7& be=e fiscal ye> #bjbd71 9 det]m9+ ! pro rata %>e to :i* ! ,unit$ ,/ates is equitably entitl$ "u subsection 7d77#c71 ! ,secret>y %all sub/itute ! ,f$]al m$ical assi/ance p]c5tage t applies = su* fiscal ye> to ! ,/ate "u section #aije7;b7 7)\t reg>d to any adju/m5ts to su* p]c5tage applicable "u su* section or any o!r provision ( law7 = ! p]c5tage t applies to su* exp5ditures "u section #aije7y74 7,b7 ,exp5ditures describ$ 9 ?is subp>agraph1 ) respect to a fiscal ye> to :i* subp>agraph 7,a7 applies1 are exp5ditures incurr$ by a ,/ate = paym5t = m$ical assi/ance provid$ to individuals describ$ 9 subclause 7,,viii7 ( section #aijb7;a77#aj77;,a77i7 by a manag$ c>e entity1 or o!r specifi$ entity 7z def9$ 9 subp>agraph 7,d77iii771 t are treat$ z remittances because ! ,/ate-- 7i7 has satisfi$ ! requirem5t ( section #dch4h ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation71 by elect+-- 7,i7 9 ! case ( a ,/ate describ$ 9 subp>agraph 7,c71 to apply a m9imum m$ical loss ratio 7z def9$ 9 subp>agraph 7,d77ii77 t is at lea/ #he p]c5t b n great] ?an ! m9imum m$ical loss ratio 7z s def9$7 t su* ,/ate appli$ z ( ,may #ca1 #bjah2 or 7,,ii7 9 ! case ( a ,/ate n describ$ 9 subp>agraph 7,c71 to apply a m9imum m$ical loss ratio t is equal to #he p]c5t2 & 7ii7 recov]$ all or a portion ( ! exp5ditures z a result ( ! entity's failure to meet su* ratio4 7,c7 ,= purposes ( subp>agraph 7,b71 a ,/ate describ$ 9 ?is subp>agraph is a ,/ate t z ( ,may #ca1 #bjah1 appli$ a m9imum m$ical loss ratio 7z calculat$ "u subsection 7d7 ( section #dch4h ( title #db1 ,code ( ,f$]al ,regulations 7z 9 effect on ,june #a1 #bjah77 = paym5t = s]vices provid$ by entities describ$ 9 su* subp>agraph "u ! ,/ate plan "u ?is title 7or a waiv] ( ! plan7 t is equal to or great] ?an #he p]c5t4 7,d7 ,= purposes ( ?is p>agraph3 7i7 ,! t]m manag$ c>e entity means a m$icaid manag$ c>e organization describ$ 9 section #aicb7;a77#a77;,b77i74 7ii7 ,! t]m m9imum m$ical loss ratio means1 ) respect to a ,/ate1 a m9imum m$ical loss ratio 7z calculat$ "u subsection 7d7 ( section #dch4h ( title #db1 ,code ( ,f$]al ,regulations 7z 9 effect on ,june #a1 #bjah77 = paym5t = s]vices provid$ by entities describ$ 9 subp>agraph 7,b7 "u ! ,/ate plan "u ?is title 7or a waiv] ( ! plan74 7iii7 ,! t]m o!r specifi$ entity means-- 7,i7 a prepaid inpati5t heal? plan1 z def9$ 9 section #dch4b ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation72 & 7,,ii7 a prepaid ambulatory heal? plan1 z def9$ 9 su* section 7or any successor regulation74 4 #djjb4 ,ext5d+ p]iod ( application ( ,m$ic>e second>y pay] rules = individuals ) end /age r5al disease ,section #ahfb7;b77#a77;,c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciey7b77#a77;,c77 is am5d$-- 7#a7 9 ! la/ s5t5ce1 by ins]t+ & be=e ,janu>y #a1 #bjbj aft] date ( enactm5t ( ! ,balanc$ ,budget ,act ( #aiig2 & 7#b7 by add+ at ! end ! foll[+ new s5t5ce3 ,effective = items & s]vices furni%$ on or aft] ,janu>y #a1 #bjbj 7) respect to p]iods beg9n+ on or aft] ,july #a1 #bjah71 clauses 7i7 & 7ii7 %all be appli$ by sub/itut+ #cc-mon? = #ab-mon? ea* place x appe>s44 #djjc4 ,requir+ report+ by gr\p heal? plans ( prescription drug cov]age in=mation = purposes ( id5tify+ prim>y pay] situations "u ! ,m$ic>e program ,clause 7i7 ( section #ahfb7;b77#g77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciey7b77#g77;,a77 is am5d$ to read z foll[s3 7i7 secure f ! plan sponsor & plan p>ticipants su* in=mation z ! ,secret>y %all specify = ! purpose ( id5tify+ situations :]e ! gr\p heal? plan is or has be5-- 7,i7 a prim>y plan to ! program "u ?is title2 or 7,,ii7 = cal5d> qu>t]s beg9n+ on or aft] ,janu>y #a1 #bjbj1 a prim>y pay] ) respect to b5efits relat+ to prescription drug cov]age "u "p ,d2 & 4 ,v ,o!r ,m$icaid ,provisions ,a ,m&atory report+ ) respect to adult behavioral heal? measures #ejja4 ,m&atory report+ ) respect to adult behavioral heal? measures ,section #aaci;,b ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#i;b7 is am5d$-- 7#a7 9 subsection 7b7-- 7,a7 9 p>agraph 7#c7-- 7i7 by /rik+ ,n lat] ?an ,janu>y #a1 #bjac & ins]t+ ! foll[+3 7,a7 ,volunt>y report+ ,n lat] ?an ,janu>y #a1 #bjac 2 & 7ii7 by add+ at ! end ! foll[+3 7,b7 ,m&atory report+ ) respect to behavioral heal? measures ,beg9n+ ) ! ,/ate report requir$ "u subsection 7d77#a7 = #bjbd1 ! ,secret>y %all require ,/ates to use all behavioral heal? measures includ$ 9 ! core set ( adult heal? quality measures & any updates or *anges to su* measures to report in=mation1 us+ ! /&>diz$ =mat = report+ in=mation & proc$ures develop$ "u subp>agraph 7,a71 reg>d+ ! quality ( behavioral heal? c>e = ,m$icaid eligible adults4 2 & 7,b7 9 p>agraph 7#e71 by add+ at ! end ! foll[+ new subp>agraph3 7,c7 ,behavioral heal? measures ,beg9n+ ) respect to ,/ate reports requir$ "u subsection 7d77#a7 = #bjbd1 ! core set ( adult heal? quality measures ma9ta9$ "u ?is p>agraph 7& any updates or *anges to su* measures7 %all include behavioral heal? measures4 2 & 7#b7 9 subsection 7d77#a77;,a7-- 7,a7 by /rik+ ! su* plan & ins]t+ su* plan2 & 7,b7 by /rik+ subsection 7a77#e7 & ins]t+ subsection 7b77#e7 &1 beg9n+ ) ! report = #bjbd1 all behavioral heal? measures includ$ 9 ! core set ( adult heal? quality measures ma9ta9$ "u su* subsection 7b77#e7 & any updates or *anges to su* measures 7z requir$ "u subsection 7b77#c774 ,b ,m$icaid ,,imd ,additional ,info #ejaa4 ,%ort title ,?is subtitle may be cit$ z ! ,m$icaid ,in/itutes = ,m5tal ,disease ,are ,decisive 9 ,deliv]+ ,inpati5t ,treatm5t = ,individuals b ,opportunities = ,ne$$ ,access are ,limit$ )\t ,in=mation ,ne$$ ab\t ,facility ,obligations ,act or ! ,m$icaid ,,imd ,,additional ,,info ,act4 #ejab4 ,,macpac exploratory /udy & report on in/itutions = m5tal diseases requirem5ts & practices "u ,m$icaid 7a7 ,9 g5]al ,n lat] ?an ,janu>y #a1 #bjbj1 ! ,m$icaid & ,,*ip ,paym5t & ,access ,commission e/abli%$ "u section #aijj ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif7 %all conduct an exploratory /udy1 us+ data f a repres5tative sample ( ,/ates1 & submit to ,congress a report on at lea/ ! foll[+ in=mation1 ) respect to s]vices furni%$ to individuals enroll$ "u ,/ate plans "u ! ,m$icaid program "u title ,,xix ( su* ,act 7#db ,u4,s4,c4 #acif et seq47 7or waiv]s ( su* plans7 :o are pati5ts 9 in/itutions = m5tal diseases & = :i* paym5t is made ?r\gh fee-=-s]vice or manag$ c>e arrangem5ts "u su* ,/ate plans 7or waiv]s73 7#a7 ,a description ( su* in/itutions = m5tal diseases 9 ea* su* ,/ate1 includ+ at a m9imum-- 7,a7 ! numb] ( su* in/itutions 9 ! ,/ate2 7,b7 ! facility type ( su* in/itutions 9 ! ,/ate2 & 7,c7 any cov]age limitations "u ea* su* ,/ate plan 7or waiv]7 on scope1 duration1 or frequ5cy ( su* s]vices4 7#b7 ,) respect to ea* su* in/itution = m5tal diseases 9 ea* su* ,/ate1 a description (-- 7,a7 su* s]vices provid$ at su* in/itution2 7,b7 ! process1 includ+ any timeframe1 us$ by su* in/itution to cl9ically assess & reassess su* individuals2 & 7,c7 ! dis*>ge process us$ by su* in/itution1 includ+ any c>e cont9uum ( relevant s]vices or facilities provid$ or us$ 9 su* process4 7#c7 ,a description (-- 7,a7 any ,f$]al waiv] t ea* su* ,/ate has = su* in/itutions & ! ,f$]al /atutory au?ority = su* waiv]2 & 7,b7 any o!r ,m$icaid fund+ s\rces us$ by ea* su* ,/ate = fund+ su* in/itutions1 su* z supplem5tal paym5ts4 7#d7 ,a summ>y ( ,/ate requirem5ts 7su* z c]tification1 lic5sure1 & accr$itation7 appli$ by ea* su* ,/ate to su* in/itutions 9 ord] = su* in/itutions to receive paym5t "u ! ,/ate plan 7or waiv]7 & h[ ea* su* ,/ate det]m9es if su* requirem5ts h be5 met4 7#e7 ,a summ>y ( ,/ate /&>ds 7su* z quality /&>ds1 cl9ical /&>ds1 & facility /&>ds7 t su* in/itutions mu/ meet to receive paym5t "u su* ,/ate plans 7or waiv]s7 & h[ ea* su* ,/ate det]m9es if su* /&>ds h be5 met4 7#f7 ,recomm5dations = actions by ,congress & ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 su* z h[ ,/ate ,m$icaid programs may improve c>e & improve /&>ds & includ+ a recomm5dation = h[ ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices c improve data collection f su* programs to address any gaps 9 in=mation4 7b7 ,/akehold] input ,9 c>ry+ out subsection 7a71 ! ,m$icaid & ,,*ip ,paym5t & ,access ,commission %all seek input f ,/ate ,m$icaid directors & /akehold]s1 includ+ at a m9imum ! ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration1 ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 ,/ate ,m$icaid (ficials1 ,/ate m5tal heal? au?orities1 ,m$icaid b5efici>y advocates1 heal? c>e provid]s1 & ,m$icaid manag$ c>e organizations4 7c7 ,def9itions ,9 ?is section3 7#a7 ,repres5tative sample ( ,/ates ,! t]m repres5tative sample ( ,/ates means a non-probability sample 9 :i* at lea/ two ,/ates are select$ bas$ on ! k & pr(essional judgm5t ( ! selector4 7#b7 ,/ate ,! t]m ,/ate means ea* ( ! #ej ,/ates1 ! ,di/rict ( ,columbia1 & any commonweal? or t]ritory ( ! ,unit$ ,/ates4 7#c7 ,in/itution = m5tal diseases ,! t]m in/itution = m5tal diseases has ! mean+ giv5 su* t]m 9 section #dce4ajji ( title #db1 ,code ( ,f$]al ,regulations1 or any successor regulation4 ,c ,,*ip ,m5tal ,heal? ,p>ity #ejba4 ,%ort title ,?is subtitle may be cit$ z ! ,,*ip ,m5tal ,heal? ,p>ity ,act4 #ejbb4 ,ensur+ access to m5tal heal? & sub/ance use disord] s]vices = *ildr5 & pregnant wom5 "u ! ,*ildr5's ,heal? ,insurance ,program 7a7 ,9 g5]al ,section #bajc7;c77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acig;cc7c77#a77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ,m5tal heal? & sub/ance use disord] s]vices 7z def9$ 9 p>agraph 7#e774 4 7b7 ,m5tal heal? & sub/ance use disord] s]vices 7#a7 ,9 g5]al ,section #bajc7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acig;cc7c77 is am5d$-- 7,a7 by r$esignat+ p>agraphs 7#e71 7#f71 7#g71 & 7#h7 z p>agraphs 7#f71 7#g71 7#h71 & 7#i71 respectively2 & 7,b7 by ins]t+ aft] p>agraph 7#d7 ! foll[+ new p>agraph3 7#e7 ,m5tal heal? & sub/ance use disord] s]vices ,reg>dless ( ! type ( cov]age elect$ by a ,/ate "u subsection 7a71 *ild heal? assi/ance provid$ "u su* cov]age = t>get$ l[-income *ildr5 &1 9 ! case t ! ,/ate elects to provide pregnancy-relat$ assi/ance "u su* cov]age pursuant to section #baab1 su* pregnancy-relat$ assi/ance = t>get$ l[-income wom5 7z def9$ 9 section #baab7;d77 %all-- 7,a7 include cov]age ( m5tal heal? s]vices 7includ+ behavioral heal? treatm5t7 necess>y to prev5t1 diagnose1 & treat a broad range ( m5tal heal? symptoms & disord]s1 includ+ sub/ance use disord]s2 & 7,b7 be deliv]$ 9 a culturally & l+ui/ically appropriate mann]4 4 7#b7 ,con=m+ am5dm5ts 7,a7 ,section #bajc7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acig;cc7a77 is am5d$1 9 ! matt] be=e p>agraph 7#a71 by /rik+ p>agraphs 7#e71 7#f71 & 7#g7 & ins]t+ p>agraphs 7#e71 7#f71 7#g71 & 7#h74 7,b7 ,section #baaj7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acig;jj7a77 is am5d$-- 7i7 9 p>agraph 7#ah71 by /rik+ sub/ance abuse ea* place x appe>s & ins]t+ sub/ance use2 & 7ii7 9 p>agraph 7#ai71 by /rik+ sub/ance abuse & ins]t+ sub/ance use4 7,c7 ,section #baaj7;b77#e77;,a77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acig;jj7b77#e77;,a77i77 is am5d$ by /rik+ subsection 7c77#e7 & ins]t+ subsection 7c77#f74 7c7 ,assur+ access to c>e ,section #bajb7;a77#g77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acig;bb7c77#b77 is am5d$ by /rik+ section #bajc7;c77#e7 & ins]t+ p>agraphs 7#e7 & 7#f7 ( section #bajc7;c74 7d7 ,m5tal heal? s]vices p>ity ,subp>agraph 7,a7 ( p>agraph 7#g7 ( section #bajc7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acig;cc7c77 7z r$esignat$ by subsection 7b77#a77 is am5d$ to read z foll[s3 7,a7 ,9 g5]al ,a ,/ate *ild heal? plan %all ensure t ! f9ancial requirem5ts & treatm5t limitations applicable to m5tal heal? & sub/ance use disord] s]vices 7z describ$ 9 p>agraph 7#e77 provid$ "u su* plan comply ) ! requirem5ts ( section #bgbf7;a7 ( ! ,public ,heal? ,s]vice ,act 9 ! same mann] z su* requirem5ts or limitations apply to a gr\p heal? plan "u su* section4 4 7e7 ,effective date 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 ! am5dm5ts made by ?is section %all take effect ) respect to *ild heal? assi/ance provid$ on or aft] ! date t is #a ye> aft] ! date ( ! enactm5t ( ?is ,act4 7#b7 ,exception = ,/ate legislation ,9 ! case ( a ,/ate *ild heal? plan "u title ,,xxi ( ! ,social ,security ,act 7or a waiv] ( su* plan71 :i* ! ,secret>y ( ,heal? & ,human ,s]vices det]m9es requires ,/ate legislation 9 ord] = ! respective plan 7or waiv]7 to meet any requirem5t impos$ by ! am5dm5ts made by ?is section1 ! respective plan 7or waiv]7 %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 section4 ,= 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 ,d ,m$icaid ,re5try #ejca4 ,%ort title ,?is subtitle may be cit$ z ! ,m$icaid ,re5try ,act4 #ejcb4 ,promot+ ,/ate innovations to ease transitions integration to ! community = c]ta9 individuals 7a7 ,/akehold] gr\p developm5t ( be/ practices2 ,/ate ,m$icaid program innovation 7#a7 ,/akehold] gr\p be/ practices ,n lat] ?an #f mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all conv5e a /akehold] gr\p ( repres5tatives ( manag$ c>e organizations1 ,m$icaid b5efici>ies1 heal? c>e provid]s1 ! ,national ,association ( ,m$icaid ,directors1 & o!r relevant repres5tatives f local1 ,/ate1 & ,f$]al jail & prison sy/ems to develop be/ practices 7& submit to ! ,secret>y & ,congress a report on su* be/ practices7 = ,/ates-- 7,a7 to ease ! heal? c>e-relat$ transition ( an individual :o is an inmate ( a public in/itution f ! public in/itution to ! community1 includ+ be/ practices = ensur+ cont9uity ( heal? insurance cov]age or cov]age "u ! ,/ate ,m$icaid plan "u title ,,xix ( ! ,social ,security ,act1 z applicable1 & relevant social s]vices2 & 7,b7 to c>ry out1 ) respect to su* an individual1 su* heal? c>e-relat$ transition n lat] ?an #cj days aft] su* individual is releas$ f ! public in/itution4 7#b7 ,/ate ,m$icaid program innovation ,! ,secret>y ( ,heal? & ,human ,s]vices %all "w ) ,/ates on innovative /rategies to help individuals :o are inmates ( public in/itutions & o!rwise eligible = m$ical assi/ance "u ! ,m$icaid program "u title ,,xix ( ! ,social ,security ,act transition1 ) respect to enrollm5t = m$ical assi/ance "u su* program1 seamlessly to ! community4 7b7 ,guidance on innovative s]vice deliv]y sy/ems demon/ration project opportunities ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 ?r\gh ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 %all issue a ,/ate ,m$icaid ,director lett]1 bas$ on be/ practices develop$ "u subsection 7a77#a71 reg>d+ opportunities to design demon/ration projects "u section #aaae ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acae7 to improve c>e transitions = c]ta9 individuals :o are soon-to-be =m] inmates ( a public in/itution & :o are o!rwise eligible to receive m$ical assi/ance "u title ,,xix ( su* ,act1 includ+ sy/ems =1 ) respect to a p]iod 7n to exce$ #cj days7 imm$iately prior to ! day on :i* su* individuals are expect$ to be releas$ f su* in/itution-- 7#a7 provid+ assi/ance & education = enrollm5t "u a ,/ate plan "u ! ,m$icaid program "u title ,,xix ( su* ,act = su* individuals dur+ su* p]iod2 & 7#b7 provid+ heal? c>e s]vices = su* individuals dur+ su* p]iod4 7c7 ,rule ( con/ruction ,no?+ "u title ,,xix ( ! ,social ,security ,act or any o!r provision ( law precludes a ,/ate f reclassify+ or susp5d+ 7r ?an t]m9at+7 eligibility ( an individual = m$ical assi/ance "u title ,,xix ( ! ,social ,security ,act :ile su* individual is an inmate ( a public in/itution4 ,e ,m$icaid ,p>tn]%ip #ejda4 ,%ort title ,?is subtitle may be cit$ z ! ,m$icaid ,provid]s ,are ,requir$ ,to ,note ,exp]i5ces 9 ,record ,sy/ems to ,help ,9-ne$ ,pati5ts ,act or ! ,m$icaid ,,p>tn]%ip ,act4 #ejdb4 ,m$icaid provid]s are requir$ to note exp]i5ces 9 record sy/ems to help 9-ne$ pati5ts 7a7 ,requirem5ts "u ! ,m$icaid program relat+ to qualifi$ prescription drug monitor+ programs & prescrib+ c]ta9 controll$ sub/ances ,title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 is am5d$ by ins]t+ aft] section #aidc ! foll[+ new section3 #aidd4 ,requirem5ts relat+ to qualifi$ prescription drug monitor+ programs & prescrib+ c]ta9 controll$ sub/ances 7a7 ,9 g5]al ,beg9n+ ,octob] #a1 #bjba1 a ,/ate %all1 subject to subsection 7d71 require ea* cov]$ provid] to *eck1 9 accordance ) su* tim+1 mann]1 & =m z specifi$ by ! ,/ate1 ! prescription drug hi/ory ( a cov]$ individual be+ treat$ by ! cov]$ provid] ?r\gh a qualifi$ prescription drug monitor+ program describ$ 9 subsection 7b7 be=e prescrib+ to su* individual a controll$ sub/ance4 7b7 ,qualifi$ prescription drug monitor+ program describ$ ,a qualifi$ prescription drug monitor+ program describ$ 9 ?is subsection is1 ) respect to a ,/ate1 a prescription drug monitor+ program adm9i/]$ by ! ,/ate t1 at a m9imum1 satisfies ea* ( ! foll[+ crit]ia3 7#a7 ,! program facilitates access by a cov]$ provid] to1 at a m9imum1 ! foll[+ in=mation ) respect to a cov]$ individual1 9 z close to real-"t z possible3 7,a7 ,in=mation reg>d+ ! prescription drug hi/ory ( a cov]$ individual ) respect to controll$ sub/ances4 7,b7 ,! numb] & type ( controll$ sub/ances prescrib$ to & fill$ = ! cov]$ individual dur+ at lea/ ! mo/ rec5t #ab-mon? p]iod4 7,c7 ,! "n1 location1 & contact in=mation 7or o!r id5tify+ numb] select$ by ! ,/ate1 su* z a national provid] id5tifi] issu$ by ! ,national ,plan & ,provid] ,enum]ation ,sy/em ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices7 ( ea* cov]$ provid] :o prescrib$ a controll$ sub/ance to ! cov]$ individual dur+ at lea/ ! mo/ rec5t #ab-mon? p]iod4 7#b7 ,! program facilitates ! integration ( in=mation describ$ 9 p>agraph 7#a7 into ! workfl[ ( a cov]$ provid]1 :i* may include ! electronic sy/em ! cov]$ provid] uses to prescribe controll$ sub/ances4 ,a qualifi$ prescription drug monitor+ program describ$ 9 ?is subsection1 ) respect to a ,/ate1 may h 9 place1 9 accordance ) applicable ,/ate & ,f$]al law1 a data %>+ agreem5t ) ! ,/ate ,m$icaid program t all[s ! m$ical director & ph>macy director ( su* program 7& any designee ( su* a director :o reports directly to su* director7 to access ! in=mation describ$ 9 p>agraph 7#a7 9 an electronic =mat4 ,! ,/ate ,m$icaid program "u ?is title may facilitate reasonable & limit$ access1 z det]m9$ by ! ,/ate & ensur+ docum5t$ b5efici>y protections reg>d+ ! use ( su* data1 to su* qualifi$ prescription drug monitor+ program = ! m$ical director or ph>macy director ( any manag$ c>e entity 7z def9$ "u section #aicb7;a77#a77;,b77 t has a contract ) ! ,/ate "u section #aijc7m7 or "u section #aije7t77#c71 or ! m$ical director or ph>macy director ( any entity has a contract to manage ! ph>maceutical b5efit ) respect to individuals enroll$ 9 ! ,/ate plan 7or waiv] ( ! ,/ate plan74 ,all applicable ,/ate & ,f$]al security & privacy laws %all apply to ! directors or designees ( su* directors ( any ,/ate ,m$icaid program or entity access+ a qualifi$ prescription drug monitor+ program "u ?is section4 7c7 ,application ( privacy rules cl>ification ,! ,secret>y %all cl>ify privacy requirem5ts1 includ+ requirem5ts "u ! regulations promulgat$ pursuant to section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7#db ,u4,s4,c4 #acbj;d-#b note71 relat$ to ! %>+ ( data "u subsection 7b7 9 ! same mann] z ! ,secret>y is requir$ "u subp>agraph 7,j7 ( section #ahfj;,d-#d7;c77#e7 to cl>ify privacy requirem5ts relat$ to ! %>+ ( data describ$ 9 su* subp>agraph4 7d7 ,ensur+ access ,9 ord] to ensure reasonable access to heal? c>e1 ! ,secret>y %all waive ! application ( ! requirem5t "u subsection 7a71 ) respect to a ,/ate1 9 ! case ( natural disa/]s & simil> situations1 & 9 ! case ( ! provision ( em]g5cy s]vices 7z def9$ = purposes ( section #ahfj;,d-#d7;c77#e77;,d77ii77,,ii774 7e7 ,reports 7#a7 ,/ate reports ,ea* ,/ate %all include 9 ! annual report submitt$ to ! ,secret>y "u section #aibg7;g77#c77;,d71 beg9n+ ) su* reports submitt$ = #bjbc1 in=mation includ+1 at a m9imum1 ! foll[+ in=mation = ! mo/ rec5t #ab-mon? p]iod3 7,a7 ,! p]c5tage ( cov]$ provid]s 7z det]m9$ pursuant to a process e/abli%$ by ! ,/ate7 :o *eck$ ! prescription drug hi/ory ( a cov]$ individual ?r\gh a qualifi$ prescription drug monitor+ program describ$ 9 subsection 7b7 be=e prescrib+ to su* individual a controll$ sub/ance4 7,b7 ,aggregate tr5ds ) respect to prescrib+ controll$ sub/ances su* z-- 7i7 ! quantity ( daily morph9e milligram equival5ts prescrib$ = controll$ sub/ances2 7ii7 ! numb] & quantity ( daily morph9e milligram equival5ts prescrib$ = controll$ sub/ances p] cov]$ individual2 & 7iii7 ! types ( controll$ sub/ances prescrib$1 includ+ ! dates ( su* prescriptions1 ! supplies au?oriz$ 7includ+ ! duration ( su* supplies71 & ! p]iod ( validity ( su* prescriptions1 9 diff]5t populations 7su* z individuals :o are eld]ly1 individuals ) disabilities1 & individuals :o are enroll$ "u bo? ?is title & title ,,xviii74 7,c7 ,:e!r or n ! ,/ate requires 7& a detail$ explanation z to :y ! ,/ate does or does n require7 ph>maci/s to *eck ! prescription drug hi/ory ( a cov]$ individual ?r\gh a qualifi$ drug managem5t program be=e disp5s+ a controll$ sub/ance to su* individual4 7#b7 ,report by ,,cms ,n lat] ?an ,octob] #a1 #bjbc1 ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices %all publi% on ! publicly available website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices a report includ+ ! foll[+ in=mation3 7,a7 ,guidance = ,/ates on h[ ,/ates c increase ! p]c5tage ( cov]$ provid]s :o use qualifi$ prescription drug monitor+ programs describ$ 9 subsection 7b74 7,b7 ,be/ practices = h[ ,/ates & cov]$ provid]s %\ld use su* qualifi$ prescription drug monitor+ programs to r$uce ! occurr5ce ( abuse ( controll$ sub/ances4 7f7 ,increase to ,f$]al mat*+ rate = c]ta9 exp5ditures relat+ to qualifi$ prescription drug managem5t programs ,! ,secret>y %all increase ! ,f$]al m$ical assi/ance p]c5tage or ,f$]al mat*+ rate t w\ld o!rwise apply to a ,/ate "u section #aijc7;a7 = a cal5d> qu>t] occurr+ dur+ ! p]iod beg9n+ ,octob] #a1 #bjah1 & end+ ,septemb] #cj1 #bjba1 = exp5ditures by ! ,/ate = activities "u ! ,/ate plan 7or waiv] ( ! ,/ate plan7 to implem5t a prescription drug managem5t program t satisfies ! crit]ia describ$ 9 p>agraphs 7#a7 & 7#b7 ( subsection 7b7 if ! ,/ate 79 ?is subsection ref]r$ to z ! adm9i/]+ ,/ate7 has 9 place agreem5ts ) all ,/ates t are contigu\s to su* adm9i/]+ ,/ate t1 :5 comb9$1 enable cov]$ provid]s 9 all su* contigu\s ,/ates to access1 ?r\gh ! prescription drug managem5t program1 ! in=mation t is describ$ 9 subsection 7b77#a7 ( cov]$ individuals ( su* adm9i/]+ ,/ate & t cov]$ provid]s 9 su* adm9i/]+ ,/ate are able to access ?r\gh su* program4 ,9 no case %all an increase "u ?is subsection result 9 a ,f$]al m$ical assi/ance p]c5tage or ,f$]al mat*+ rate t exce$s #ajj p]c5t4 7g7 ,rule ( con/ruction ,no?+ 9 ?is section prev5ts a ,/ate f requir+ ph>maci/s to *eck ! prescription drug hi/ory ( cov]$ individuals ?r\gh a qualifi$ drug managem5t program be=e disp5s+ controll$ sub/ances to su* individuals4 7h7 ,def9itions ,9 ?is section3 7#a7 ,controll$ sub/ance ,! t]m controll$ sub/ance means a drug t is includ$ 9 s*$ule ,,ii ( section #bjb7;c7 ( ! ,controll$ ,sub/ances ,act &1 at ! option ( ! ,/ate involv$1 a drug includ$ 9 s*$ule ,,iii or ,,iv ( su* section4 7#b7 ,cov]$ individual ,! t]m cov]$ individual means1 ) respect to a ,/ate1 an individual :o is enroll$ 9 ! ,/ate plan 7or "u a waiv] ( su* plan74 ,su* t]m does n include an individual :o-- 7,a7 is receiv+-- 7i7 hospice or palliative c>e2 or 7ii7 treatm5t = canc]2 7,b7 is a resid5t ( a long-t]m c>e facility1 ( a facility describ$ 9 section #aije7;d71 or ( ano!r facility = :i* frequ5tly abus$ drugs are disp5s$ = resid5ts ?r\gh a contract ) a s+le ph>macy2 or 7,c7 ! ,/ate elects to treat z exempt$ f su* t]m4 7#c7 ,cov]$ provid] 7,a7 ,9 g5]al ,! t]m cov]$ provid] means1 subject to subp>agraph 7,b71 ) respect to a ,/ate1 a heal? c>e provid] :o is p>ticipat+ "u ! ,/ate plan 7or waiv] ( ! ,/ate plan7 & lic5s$1 regi/]$1 or o!rwise p]mitt$ by ! ,/ate to prescribe a controll$ sub/ance 7or ! designee ( su* provid]74 7,b7 ,exceptions 7i7 ,9 g5]al ,beg9n+ ,octob] #a1 #bjba1 = purposes ( ?is section1 su* t]m does n include a heal? c>e provid] includ$ 9 any type ( heal? c>e provid] det]m9$ by ! ,secret>y to be exempt f application ( ?is section "u clause 7ii74 7ii7 ,exceptions process ,n lat] ?an ,octob] #a1 #bjbj1 ! ,secret>y1 aft] consultation ) ! ,national ,association ( ,m$icaid ,directors1 national heal? c>e provid] associations1 ,m$icaid b5efici>y advocates1 & advocates = individuals ) r>e diseases1 %all det]m9e1 bas$ on su* consultations1 ! types ( heal? c>e provid]s 7if any7 t %\ld be exempt$ f ! def9ition ( ! t]m cov]$ provid] = purposes ( ?is section4 4 7b7 ,guidance ,n lat] ?an ,octob] #a1 #bjai1 ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 9 consultation ) ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all issue guidance on be/ practices on ! uses ( prescription drug monitor+ programs requir$ ( prescrib]s & on protect+ ! privacy ( ,m$icaid b5efici>y in=mation ma9ta9$ 9 & access$ ?r\gh prescription drug monitor+ programs4 7c7 ,developm5t ( model ,/ate practices 7#a7 ,9 g5]al ,n lat] ?an ,octob] #a1 #bjbj1 ! ,secret>y ( ,heal? & ,human ,s]vices %all develop & publi% model practices to assi/ ,/ate ,m$icaid program op]ations 9 id5tify+ & implem5t+ /rategies to utilize data %>+ agreem5ts describ$ 9 ! matt] foll[+ p>agraph 7#b7 ( section #aidd7;b7 ( ! ,social ,security ,act1 z add$ by subsection 7a71 = ! foll[+ purposes3 7,a7 ,monitor+ & prev5t+ fraud1 wa/e1 & abuse4 7,b7 ,improv+ heal? c>e = individuals enroll$ 9 a ,/ate plan "u title ,,xix ( su* ,act 7or waiv] ( su* plan7 :o-- 7i7 transition 9 & out ( cov]age "u su* title2 7ii7 may h s\rces ( heal? c>e cov]age 9 addition to cov]age "u su* title2 or 7iii7 pay = prescription drugs ) ca%4 7,c7 ,any o!r purposes specifi$ by ! ,secret>y4 7#b7 ,elem5ts ( model practices ,! model practices describ$ 9 p>agraph 7#a7-- 7,a7 %all include /rategies = assi/+ ,/ates 9 all[+ ! m$ical director or ph>macy director 7or designees ( su* a director7 ( manag$ c>e organizations or ph>maceutical b5efit manag]s to access in=mation ) respect to all cov]$ individuals s]v$ by su* manag$ c>e organizations or ph>maceutical b5efit manag]s to access z a s+le data set1 9 an electronic =mat2 & 7,b7 %all include any appropriate b5efici>y protections & privacy guidel9es4 7#c7 ,consultation ,9 develop+ model practices "u ?is subsection1 ! ,secret>y %all consult ) ! ,national ,association ( ,m$icaid ,directors1 manag$ c>e entities 7z def9$ 9 section #aicb7;a77#a77;,b7 ( ! ,social ,security ,act7 ) contracts ) ,/ates pursuant to section #aijc7m7 ( su* ,act1 ph>maceutical b5efit manag]s1 physicians & o!r heal? c>e provid]s1 b5efici>y advocates1 & individuals ) exp]tise 9 heal? c>e te*nology relat$ to prescription drug monitor+ programs & electronic heal? records4 7d7 ,report by ,comptroll] ,g5]al ,n lat] ?an ,octob] #a1 #bjbj1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all issue a report exam9+ ! op]ation ( prescription drug monitor+ programs adm9i/]$ by ,/ates1 includ+ data security & access /&>ds us$ by su* programs4 ,,vi ,o!r ,m$ic>e ,provisions ,a ,te/+ ( inc5tive paym5ts = behavioral heal? provid]s = adoption & use ( c]tifi$ electronic heal? record te*nology #fjja4 ,te/+ ( inc5tive paym5ts = behavioral heal? provid]s = adoption & use ( c]tifi$ electronic heal? record te*nology ,section #aaae;,a7b77#b77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acae;a7b77#b77;,b77 is am5d$ by add+ at ! end ! foll[+ new clause3 7xxv7 ,provid+1 = ! adoption & use ( c]tifi$ ,,ehr te*nology 7z def9$ 9 section #ahdh7o77#d77 to improve ! quality & coord9ation ( c>e ?r\gh ! electronic docum5tation & ex*ange ( heal? in=mation1 inc5tive paym5ts to behavioral heal? provid]s 7su* z psy*iatric hospitals 7z def9$ 9 section #ahfa7;f771 community m5tal heal? c5t]s 7z def9$ 9 section #ahfa7;ff77#c77;,b771 hospitals t p>ticipate 9 a ,/ate plan "u title ,,xix or a waiv] ( su* plan1 treatm5t facilities t p>ticipate 9 su* a ,/ate plan or su* a waiv]1 m5tal heal? or sub/ance use disord] provid]s t p>ticipate 9 su* a ,/ate plan or su* a waiv]1 cl9ical psy*ologi/s 7z def9$ 9 section #ahfa7;ii771 nurse practition]s 7z def9$ 9 section #ahfa7;aa77#e77 ) respect to ! provision ( psy*iatric s]vices1 & cl9ical social work]s 7z def9$ 9 section #ahfa7;hh77#a7774 4 ,b ,abuse ,det]r5t ,access #fjaa4 ,%ort title ,?is subtitle may be cit$ at ! ,abuse ,det]r5t ,access ,act ( #bjah4 #fjab4 ,/udy on abuse-det]r5t opioid =mulations access b>ri]s "u ,m$ic>e 7a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all conduct a /udy & submit to ,congress a report on ! adequacy ( access to abuse-det]r5t opioid =mulations = individuals ) *ronic pa9 enroll$ 9 an ,,ma-,,pd plan "u "p ,c ( title ,,xviii ( ! ,social ,security ,act or a prescription drug plan "u "p ,d ( su* title ( su* ,act1 tak+ into acc\nt any b>ri]s prev5t+ su* individuals f access+ su* =mulations "u su* ,,ma-,,pd or "p ,d plans1 su* z co/-%>+ ti]s1 fail-fir/ requirem5ts1 ! price ( su* =mulations1 & prior au?orization requirem5ts4 7b7 ,def9ition ( abuse-det]r5t opioid =mulation ,9 ?is section1 ! t]m abuse-det]r5t opioid =mulation means an opioid t is a prodrug or t has c]ta9 abuse-det]r5t prop]ties1 su* z physical or *emical b>ri]s1 agoni/ or antagoni/ comb9ations1 av]sion prop]ties1 deliv]y sy/em me*anisms1 or o!r features design$ to prev5t abuse ( su* opioid4 ,c ,m$ic>e ,opioid ,safety ,education #fjba4 ,%ort title ,?is subtitle may be cit$ z ! ,m$ic>e ,opioid ,safety ,education ,act ( #bjah4 #fjbb4 ,provision ( in=mation reg>d+ opioid use & pa9 managem5t z "p ( ,m$ic>e ,y h&book 7a7 ,9 g5]al ,section #ahjd ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;b-#b7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7d7 ,! notice provid$ "u subsection 7a7 %all include-- 7#a7 educational res\rces1 compil$ by ! ,secret>y1 reg>d+ opioid use & pa9 managem5t2 & 7#b7 a description ( alt]native1 non-opioid pa9 managem5t treatm5ts cov]$ "u ?is title4 4 7b7 ,effective date ,! am5dm5t made by subsection 7a7 %all apply to notices di/ribut$ prior to ea* ,m$ic>e op5 enrollm5t p]iod beg9n+ aft] ,janu>y #a1 #bjai4 ,d ,opioid ,addiction ,action ,plan #fjca4 ,%ort title ,?is subtitle may be cit$ z ! ,opioid ,addiction ,action ,plan ,act4 #fjcb4 ,action plan on recomm5dations = *anges "u ,m$ic>e & ,m$icaid to prev5t opioids addictions & enhance access to m$ication-assi/$ treatm5t 7a7 ,9 g5]al ,n lat] ?an ,janu>y #a1 #bjai1 ! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y71 9 collaboration ) ! ,pa9 ,managem5t ,be/ ,practices ,int]-,ag5cy ,task ,=ce conv5$ "u section #aja7;b7 ( ! ,compreh5sive ,addiction & ,recov]y ,act ( #bjaf 7,public ,law #aad-aih71 %all develop an action plan t provides recomm5dations describ$ 9 subsection 7b74 7b7 ,action plan compon5ts ,recomm5dations describ$ 9 ?is subsection are1 bas$ on an exam9ation by ! ,secret>y ( pot5tial ob/acles to an effective response to ! opioid crisis1 recomm5dations1 z det]m9$ appropriate by ! ,secret>y1 on ! foll[+3 7#a7 ,recomm5dations on *anges to ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act & ! ,m$icaid program "u title ,,xix ( su* ,act t w\ld enhance cov]age & paym5t "u su* programs ( all m$ication-assi/$ treatm5t approv$ by ! ,food & ,drug ,adm9i/ration = ! treatm5t ( opioid addiction & o!r !rapies t manage *ronic & acute pa9 & treat & m9imize risk ( opioid addiction1 includ+ recomm5dations on *anges to ! ,m$ic>e prospective paym5t sy/em = hospital inpati5t dep>tm5t s]vices "u section #ahhf7;d7 ( su* ,act 7#db ,u4,s4,c4 #acieww7d77 & ! ,m$ic>e prospective paym5t sy/em = hospital outpati5t dep>tm5t s]vices "u section #ahcc7t7 ( su* ,act 7#db ,u4,s4,c4 #aciel7t77 t w\ld all[ = sep>ate paym5t = su* !rapies1 if m$ically appropriate & if necess>y to enc\rage developm5t & adoption ( su* !rapies4 7#b7 ,recomm5dations = paym5t & s]vice deliv]y models to be te/$ by ! ,c5t] = ,m$ic>e & ,m$icaid ,innovation & o!r f$]ally au?oriz$ demon/ration projects1 includ+ value-bas$ models1 t may enc\rage ! use ( appropriate m$ication-assi/$ treatm5t approv$ by ! ,food & ,drug ,adm9i/ration = ! treatm5t ( opioid addiction & o!r !rapies t manage *ronic & acute pa9 & treat & m9imize risk ( opioid addiction4 7#c7 ,recomm5dations = data collection t c\ld facilitate rese>* & policy mak+ reg>d+ prev5tion ( opioid addiction & cov]age & paym5t "u ! ,m$ic>e & ,m$icaid programs ( appropriate opioid addiction treatm5ts4 7#d7 ,recomm5dations = policies "u ! ,m$ic>e program & "u ! ,m$icaid program t c exp& access = rural1 or m$ically und]s]v$ communities to ! full range ( m$ication-assi/$ treatm5t approv$ by ! ,food & ,drug ,adm9i/ration = ! treatm5t ( opioid addiction & o!r !rapies t manage *ronic & acute pa9 & treatm5t & m9imize risk ( opioid addiction4 7#e7 ,recomm5dations on *anges to ! ,m$ic>e program & ! ,m$icaid program to address cov]age or paym5t b>ri]s to pati5t access to m$ical devices t are non-opioid bas$ treatm5ts approv$ by ! ,food & ,drug ,adm9i/ration = ! managem5t ( acute pa9 & *ronic pa91 = monitor+ sub/ance use )drawal & prev5t+ ov]doses ( controll$ sub/ances1 & = treat+ sub/ance use disord]4 7c7 ,/akehold] meet+s 7#a7 ,9 g5]al ,beg9n+ n lat] ?an #c mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y %all conv5e a public /akehold] meet+ to solicit public comm5t on ! compon5ts ( ! action plan recomm5dations describ$ 9 subsection 7b74 7#b7 ,p>ticipants ,p>ticipants ( meet+s describ$ 9 p>agraph 7#a7 %all include repres5tatives f ! ,food & ,drug ,adm9i/ration & ,national ,in/itutes ( ,heal?1 bioph>maceutical indu/ry memb]s1 m$ical rese>*]s1 heal? c>e provid]s1 ! m$ical device indu/ry1 ! ,m$ic>e program1 ! ,m$icaid program1 & pati5t advocates4 7d7 ,reque/ = in=mation ,n lat] ?an #c mon?s aft] ! date ( ! enactm5t ( ?is section1 ! ,secret>y %all issue a reque/ = in=mation seek+ public fe$back reg>d+ ways 9 :i* ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices c help address ! opioid crisis ?r\gh ! developm5t ( & application ( ! action plan4 7e7 ,report to ,congress ,n lat] ?an ,june #a1 #bjai1 ! ,secret>y %all submit to ,congress1 & make public1 a report t includes-- 7#a7 a summ>y ( recomm5dations t h em]g$ "u ! action plan2 7#b7 ! ,secret>y's plann$ next /eps ) respect to ! action plan2 & 7#c7 an evaluation ( price tr5ds = drugs us$ to rev]se opioid ov]doses 7su* z naloxone71 includ+ recomm5dations on ways to l[] su* prices = consum]s4 7f7 ,def9ition ( ,m$ication-,assi/$ treatm5t ,9 ?is section1 ! t]m m$ication-assi/$ treatm5t includes opioid treatm5t programs1 behavioral !rapy1 & m$ications to treat sub/ance abuse disord]4 ,e ,advanc+ ,high ,quality ,treatm5t = ,opioid ,use ,disord]s 9 ,m$ic>e #fjda4 ,%ort title ,?is subtitle may be cit$ z ! ,advanc+ ,high ,quality ,treatm5t = ,opioid ,use ,disord]s 9 ,m$ic>e ,act4 #fjdb4 ,opioid use disord] treatm5t demon/ration program ,title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 is am5d$ by ins]t+ aft] section #ahff;,e 7#db ,u4,s4,c4 #acie;cc-#e7 ! foll[+ new section3 #ahff;,f4 ,opioid use disord] treatm5t demon/ration program 7a7 ,implem5tation ( #d-ye> demon/ration program 7#a7 ,9 g5]al ,n lat] ?an ,janu>y #a1 #bjba1 ! ,secret>y %all implem5t a #d-ye> demon/ration program "u ?is title 79 ?is section ref]r$ to z ! ,program7 to increase access ( applicable b5efici>ies to opioid use disord] treatm5t s]vices1 improve physical & m5tal heal? outcomes = su* b5efici>ies1 & to ! ext5t possible1 r$uce exp5ditures "u ?is title4 ,"u ! ,program1 ! ,secret>y %all make paym5ts "u subsection 7e7 to p>ticipants 7z def9$ 9 subsection 7c77#a77;,a77 = furni%+ opioid use disord] treatm5t s]vices deliv]$ ?r\gh opioid use disord] c>e teams1 or arrang+ = su* s]vices to be furni%$1 to applicable b5efici>ies p>ticipat+ 9 ! ,program4 7#b7 ,opioid use disord] treatm5t s]vices ,= purposes ( ?is section1 ! t]m opioid use disord] treatm5t s]vices-- 7,a7 means1 ) respect to an applicable b5efici>y1 s]vices t are furni%$ = ! treatm5t ( opioid use disord]s & t utilize drugs approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act = ! treatm5t ( opioid use disord]s 9 an outpati5t sett+2 & 7,b7 includes-- 7i7 m$ication assi/$ treatm5t2 7ii7 treatm5t plann+2 7iii7 psy*iatric1 psy*ological1 or c\nsel+ s]vices 7or any comb9ation ( su* s]vices71 z appropriate2 7iv7 social support s]vices1 z appropriate2 & 7v7 c>e managem5t & c>e coord9ation s]vices1 includ+ coord9ation ) o!r provid]s ( s]vices & suppli]s n on an opioid use disord] c>e team4 7b7 ,program design 7#a7 ,9 g5]al ,! ,secret>y %all design ! ,program 9 su* a mann] to all[ = ! evaluation ( ! ext5t to :i* ! ,program accompli%es ! foll[+ purposes3 7,a7 ,r$uces hospitalizations & em]g5cy dep>tm5t visits4 7,b7 ,increases use ( m$ication-assi/$ treatm5t = opioid use disord]s4 7,c7 ,improves heal? outcomes ( individuals ) opioid use disord]s1 includ+ by r$uc+ ! incid5ce ( infecti\s diseases 7su* z hepatitis ,c & ,,hiv74 7,d7 ,does n increase ! total sp5d+ on items & s]vices "u ?is title4 7,e7 ,r$uces dea?s f opioid ov]dose4 7,f7 ,r$uces ! utilization ( inpati5t resid5tial treatm5t4 7#b7 ,consultation ,9 design+ ! ,program1 includ+ ! crit]ia "u subsection 7e77#b77;,a71 ! ,secret>y %all1 n lat] ?an #c mon?s aft] ! date ( ! enactm5t ( ?is section1 consult ) speciali/s 9 ! field ( addiction1 cl9icians 9 ! prim>y c>e community1 & b5efici>y gr\ps4 7c7 ,p>ticipants2 opioid use disord] c>e teams 7#a7 ,p>ticipants 7,a7 ,def9ition ,9 ?is section1 ! t]m p>ticipant means an entity or individual-- 7i7 t is o!rwise enroll$ "u ?is title & t is-- 7,i7 a physician 7z def9$ 9 section #ahfa7r77#a772 7,,ii7 a gr\p practice compris$ ( at lea/ "o physician describ$ 9 subclause 7,i72 7,,iii7 a hospital outpati5t dep>tm5t2 7,,iv7 a f$]ally qualifi$ heal? c5t] 7z def9$ 9 section #ahfa7;aa77#d772 7,v7 a rural heal? cl9ic 7z def9$ 9 section #ahfa7;aa77#b772 7,,vi7 a community m5tal heal? c5t] 7z def9$ 9 section #ahfa7;ff77#c77;,b772 7,,vii7 a cl9ic c]tifi$ z a c]tifi$ community behavioral heal? cl9ic pursuant to section #bbc ( ! ,protect+ ,access to ,m$ic>e ,act ( #bjad2 or 7,,viii7 any o!r individual or entity specifi$ by ! ,secret>y2 7ii7 t appli$ = & 0 select$ to p>ticipate 9 ! ,program pursuant to an application & selection process e/abli%$ by ! ,secret>y2 & 7iii7 t e/abli%es an opioid use disord] c>e team 7z def9$ 9 p>agraph 7#b77 ?r\gh employ+ or contract+ ) heal? c>e practition]s describ$ 9 p>agraph 7#b77;,a71 & uses su* team to furni% or arrange = opioid use disord] treatm5t s]vices 9 ! outpati5t sett+ "u ! ,program4 7,b7 ,pref]5ce ,9 select+ p>ticipants = ! ,program1 ! ,secret>y %all give pref]5ce to individuals & entities t are locat$ 9 areas ) a preval5ce ( opioid use disord]s t is high] ?an ! national av]age preval5ce4 7#b7 ,opioid use disord] c>e teams 7,a7 ,9 g5]al ,= purposes ( ?is section1 ! t]m opioid use disord] c>e team means a team ( heal? c>e practition]s e/abli%$ by a p>ticipant describ$ 9 p>agraph 7#a77;,a7 t-- 7i7 %all include-- 7,i7 at lea/ "o physician 7z def9$ 9 section #ahfa7r77#a77 furni%+ prim>y c>e s]vices or addiction treatm5t s]vices to an applicable b5efici>y2 & 7,,ii7 at lea/ "o eligible practition] 7z def9$ 9 p>agraph 7#c77;,a771 :o may be a physician :o meets ! crit]ion 9 subclause 7,i72 & 7ii7 may include o!r practition]s lic5s$ "u ,/ate law to furni% psy*iatric1 psy*ological1 c\nsel+1 & social s]vices to applicable b5efici>ies4 7,b7 ,requirem5ts = receipt ( paym5t "u ,program ,9 ord] to receive paym5ts "u subsection 7e71 ea* p>ticipant 9 ! ,program %all-- 7i7 furni% opioid use disord] treatm5t s]vices ?r\gh opioid use disord] c>e teams to applicable b5efici>ies :o agree to receive ! s]vices2 7ii7 meet m9imum crit]ia1 z e/abli%$ by ! ,secret>y2 & 7iii7 submit to ! ,secret>y1 9 su* =m1 mann]1 & frequ5cy z specifi$ by ! ,secret>y1 ) respect to ea* applicable b5efici>y = :om opioid use disord] treatm5t s]vices are furni%$ by ! opioid use disord] c>e team1 data & su* o!r in=mation z ! ,secret>y det]m9es appropriate to-- 7,i7 monitor & evaluate ! ,program2 7,,ii7 det]m9e if m9imum crit]ia are met "u clause 7ii72 & 7,,iii7 det]m9e ! inc5tive paym5t "u subsection 7e74 7#c7 ,eligible practition]s2 ,o!r provid]-relat$ def9itions & application provisions 7,a7 ,eligible practition]s ,= purposes ( ?is section1 ! t]m eligible practition] means a physician or o!r heal? c>e practition]1 su* z a nurse practition]1 t-- 7i7 is enroll$ "u section #ahff7;j77#a72 7ii7 is au?oriz$ to prescribe or disp5se n>cotic drugs to individuals = ma9t5ance treatm5t or detoxification treatm5t2 & 7iii7 has 9 effect a waiv] 9 accordance ) section #cjc7;g7 ( ! ,controll$ ,sub/ances ,act = su* purpose & is o!rwise 9 compliance ) regulations promulgat$ by ! ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration to c>ry out su* section4 7,b7 ,addiction speciali/s ,= purposes ( subsection 7e77#a77;,b77iv71 ! t]m addiction speciali/ means a physician t possesses exp]t k & skills 9 addiction m$ic9e1 z evid5c$ by appropriate c]tification f a specialty body1 a c]tificate ( advanc$ qualification 9 addiction m$ic9e1 or completion ( an accr$it$ resid5cy or fell[%ip 9 addiction m$ic9e or addiction psy*iatry1 z det]m9$ by ! ,secret>y4 7d7 ,p>ticipation ( applicable b5efici>ies 7#a7 ,applicable b5efici>y def9$ ,9 ?is section1 ! t]m applicable b5efici>y means an individual :o-- 7,a7 is entitl$ to1 or enroll$ =1 b5efits "u "p ,a & enroll$ = b5efits "u "p ,b2 7,b7 is n enroll$ 9 a ,m$ic>e ,advantage plan "u "p ,c2 7,c7 has a curr5t diagnosis = an opioid use disord]2 & 7,d7 meets su* o!r crit]ia z ! ,secret>y det]m9es appropriate4 ,su* t]m %all include an individual :o is dually eligible = b5efits "u ?is title & title ,,xix if su* individual satisfies ! crit]ia describ$ 9 subp>agraphs 7,a7 ?r\gh 7,d74 7#b7 ,volunt>y b5efici>y p>ticipation2 limitation on numb] ( b5efici>ies ,an applicable b5efici>y may p>ticipate 9 ! ,program on a volunt>y basis & may t]m9ate p>ticipation 9 ! ,program at any "t4 ,n m ?an #bj1jjj applicable b5efici>ies may p>ticipate 9 ! ,program at any "t4 7#c7 ,s]vices ,9 ord] to p>ticipate 9 ! ,program1 an applicable b5efici>y %all agree to receive opioid use disord] treatm5t s]vices f a p>ticipant4 ,p>ticipation "u ! ,program %all n affect cov]age ( or paym5t = any o!r item or s]vice "u ?is title = ! applicable b5efici>y4 7#d7 ,b5efici>y access to s]vices ,no?+ 9 ?is section %all be con/ru$ z enc\rag+ provid]s to limit applicable b5efici>y access to s]vices cov]$ "u ?is title & applicable b5efici>ies %all n be requir$ to rel9qui% access to any b5efit "u ?is title z a condition ( receiv+ s]vices f a p>ticipant 9 ! ,program4 7e7 ,paym5ts 7#a7 ,p] applicable b5efici>y p] mon? c>e managem5t fee 7,a7 ,9 g5]al ,! ,secret>y %all e/abli% a s*$ule ( p] applicable b5efici>y p] mon? c>e managem5t fees4 ,su* a p] applicable b5efici>y p] mon? c>e managem5t fee %all be paid to a p>ticipant 9 addition to any o!r am\nt o!rwise payable "u ?is title to ! heal? c>e practition]s 9 ! p>ticipant's opioid use disord] c>e team or1 if applicable1 to ! p>ticipant4 ,a p>ticipant may use su* p] applicable b5efici>y p] mon? c>e managem5t fee to deliv] additional s]vices to applicable b5efici>ies1 includ+ s]vices n o!rwise eligible = paym5t "u ?is title4 7,b7 ,paym5t am\nts ,9 c>ry+ out subp>agraph 7,a71 ! ,secret>y %all-- 7i7 consid] paym5ts o!rwise payable "u ?is title = opioid use disord] treatm5t s]vices & ! ne$s ( applicable b5efici>ies2 7ii7 pay a high] p] applicable b5efici>y p] mon? c>e managem5t fee = an applicable b5efici>y :o receives m int5sive treatm5t s]vices f a p>ticipant & = :om ^? s]vices are appropriate bas$ on cl9ical guidel9es = opioid use disord] c>e2 7iii7 pay a high] p] applicable b5efici>y p] mon? c>e managem5t fee = ! mon? 9 :i* ! applicable b5efici>y beg9s treatm5t ) a p>ticipant ?an 9 subsequ5t mon?s1 to reflect ! great] "t & co/s requir$ = ! plann+ & initiation ( treatm5t1 z comp>$ to ma9t5ance ( treatm5t2 7iv7 pay high] p] applicable b5efici>y p] mon? c>e managem5t fees = p>ticipants t h e/abli%$ opioid use disord] c>e teams t include an addiction speciali/ 7z def9$ 9 subsection 7c77#c77;,b772 & 7v7 take into acc\nt :e!r a p>ticipant's opioid use disord] c>e team ref]s applicable b5efici>ies to o!r suppli]s or provid]s = any opioid use disord] treatm5t s]vices4 7,c7 ,no duplicate paym5t ,! ,secret>y %all make paym5ts "u ?is p>agraph to only "o p>ticipant = s]vices furni%$ to an applicable b5efici>y dur+ a cal5d> mon?4 7#b7 ,inc5tive paym5ts 7,a7 ,9 g5]al ,"u ! ,program1 ! ,secret>y %all e/abli% a p]=mance-bas$ inc5tive paym5t1 :i* %all be paid 7us+ a me?odology e/abli%$ & at a "t det]m9$ appropriate by ! ,secret>y7 to p>ticipants bas$ on ! p]=mance ( p>ticipants ) respect to crit]ia1 z det]m9$ appropriate by ! ,secret>y1 9 accordance ) subp>agraph 7,b74 7,b7 ,crit]ia 7i7 ,9 g5]al ,crit]ia describ$ 9 subp>agraph 7,a7 may include consid]ation ( ! foll[+3 7,i7 ,pati5t engagem5t & ret5tion 9 treatm5t4 7,,ii7 ,evid5ce-bas$ m$ication-assi/$ treatm5t4 7,,iii7 ,o!r crit]ia e/abli%$ by ! ,secret>y4 7ii7 ,requir$ consultation & consid]ation ,9 det]m9+ crit]ia describ$ 9 subp>agraph 7,a71 ! ,secret>y %all-- 7,i7 consult ) /akehold]s1 includ+ cl9icians 9 ! prim>y c>e community & 9 ! field ( addiction m$ic9e2 & 7,,ii7 consid] exi/+ cl9ical guidel9es = ! treatm5t ( opioid use disord]s4 7,c7 ,no duplicate paym5t ,! ,secret>y %all ensure t no duplicate paym5ts "u ?is p>agraph are made ) respect to an applicable b5efici>y4 7f7 ,multipay] /rategy ,9 c>ry+ out ! ,program1 ! ,secret>y %all enc\rage o!r pay]s to provide simil> paym5ts & to use simil> crit]ia z appli$ "u ! ,program "u subsection 7e77#b77;,c74 ,! ,secret>y may ent] into a memor&um ( und]/&+ ) o!r pay]s to align ! me?odology = paym5t provid$ by su* a pay] relat$ to opioid use disord] treatm5t s]vices ) su* me?odology = paym5t "u ! ,program4 7g7 ,evaluation 7#a7 ,9 g5]al ,! ,secret>y %all conduct an int]m$iate & f9al evaluation ( ! program4 ,ea* su* evaluation %all det]m9e ! ext5t to :i* ea* ( ! purposes describ$ 9 subsection 7b7 h be5 accompli%$ "u ! ,program4 7#b7 ,reports ,! ,secret>y %all submit to ! ,secret>y & ,congress-- 7,a7 a report ) respect to ! int]m$iate evaluation "u p>agraph 7#a7 n lat] ?an #c ye>s aft] ! date ( ! implem5tation ( ! ,program2 & 7,b7 a report ) respect to ! f9al evaluation "u p>agraph 7#a7 n lat] ?an #f ye>s aft] su* date4 7h7 ,fund+ 7#a7 ,adm9i/rative fund+ ,= ! purposes ( implem5t+1 adm9i/]+1 & c>ry+ out ! ,program 7o!r ?an = purposes describ$ 9 p>agraph 7#b771 #e1jjj1jjj %all be available f ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund "u section #ahda4 7#b7 ,c>e managem5t fees & inc5tives ,= ! purposes ( mak+ paym5ts "u subsection 7e71 #aj1jjj1jjj %all be available f ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund "u section #ahda = ea* ( fiscal ye>s #bjba ?r\gh #bjbd4 7#c7 ,availability ,am\nts transf]r$ "u ?is subsection = a fiscal ye> %all be available until exp5d$4 7i7 ,waiv]s ,! ,secret>y may waive any provision ( ?is title z may be necess>y to c>ry out ! ,program "u ?is section4 4 ,f ,responsible ,education ,a*ieves ,c>e & ,heal?y ,outcomes = ,us]s' ,treatm5t #fjea4 ,%ort title ,?is subtitle may be cit$ z ! ,responsible ,education ,a*ieves ,c>e & ,heal?y ,outcomes = ,us]s' ,treatm5t ,act ( #bjah or ! ,,rea* ,,out ,act ( #bjah4 #fjeb4 ,grants to provide te*nical assi/ance to outli] prescrib]s ( opioids 7a7 ,grants au?oriz$ ,! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 %all1 ?r\gh ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 aw>d grants1 contracts1 or coop]ative agreem5ts to eligible entities = ! purposes describ$ 9 subsection 7b74 7b7 ,use ( funds ,grants1 contracts1 & coop]ative agreem5ts aw>d$ "u subsection 7a7 %all be us$ to support eligible entities ?r\gh te*nical assi/ance-- 7#a7 to educate & provide outrea* to outli] prescrib]s ( opioids ab\t be/ practices = prescrib+ opioids2 7#b7 to educate & provide outrea* to outli] prescrib]s ( opioids ab\t non-opioid pa9 managem5t !rapies2 & 7#c7 to r$uce ! am\nt ( opioid prescriptions prescrib$ by outli] prescrib]s ( opioids4 7c7 ,application ,ea* eligible entity seek+ to receive a grant1 contract1 or coop]ative agreem5t "u subsection 7a7 %all submit to ! ,secret>y an application1 at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y may require4 7d7 ,geographic di/ribution ,9 aw>d+ grants1 contracts1 & coop]ative agreem5ts "u ?is section1 ! ,secret>y %all prioritize e/abli%+ te*nical assi/ance res\rces 9 ea* ,/ate4 7e7 ,def9itions ,9 ?is section3 7#a7 ,eligible entity ,! t]m eligible entity means-- 7,a7 an organization-- 7i7 t has demon/rat$ exp]i5ce provid+ te*nical assi/ance to heal? c>e pr(essionals on a ,/ate or regional basis2 & 7ii7 t has at lea/-- 7,i7 "o individual :o is a repres5tative ( consum]s on its gov]n+ body2 & 7,,ii7 "o individual :o is a repres5tative ( heal? c>e provid]s on its gov]n+ body2 or 7,b7 an entity t is a quality improvem5t entity ) a contract "u "p ,b ( title ,,xi ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;c et seq474 7#b7 ,outli] prescrib] ( opioids ,! t]m outli] prescrib] ( opioids means a prescrib]1 id5tifi$ by ! ,secret>y ( ,heal? & ,human ,s]vices 7?r\gh use ( prescrib] in=mation provid$ by prescrib] ,national ,provid] ,id5tifi]s includ$ pursuant to section #ahfj;,d-#d7;c77#d77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c77#d77;,a77 on claims = cov]$ "p ,d drugs = "p ,d eligible individuals enroll$ 9 prescription drug plans "u "p ,d ( title ,,xviii ( su* ,act 7#db ,u4,s4,c4 #aciew-#aja et seq47 & ,,ma-,,pd plans "u "p ,c ( su* title 7#db ,u4,s4,c4 #aciew-#ba et seq477 z prescrib+1 z comp>$ to o!r prescrib]s 9 ! specialty ( ! prescrib] & geographic area1 am\nts ( opioids 9 excess ( a ?re%old 7& o!r crit]ia7 specifi$ by ! ,secret>y1 aft] consultation ) /akehold]s4 7#c7 ,prescrib]s ,! t]m prescrib] means any heal? c>e pr(essional1 includ+ a nurse practition] or physician assi/ant1 :o is lic5s$ to prescribe opioids by ! ,/ate or t]ritory 9 :i* su* pr(essional practices4 7f7 ,fund+ ,= purposes ( implem5t+ ?is section1 #ge1jjj1jjj %all be available f ! ,f$]al ,supplem5t>y ,m$ical ,insurance ,tru/ ,fund "u section #ahda ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciet71 to rema9 available until exp5d$4 ,g ,prev5t+ ,addiction = ,susceptible ,s5iors #fjfa4 ,%ort title ,?is subtitle may be cit$ z ! ,prev5t+ ,addiction = ,susceptible ,s5iors ,act ( #bjah or ! ,,pass ,act ( #bjah 4 #fjfb4 ,electronic prior au?orization = cov]$ "p ,d drugs 7a7 ,inclusion 9 electronic prescription program ,section #ahfj;,d-#d7;e77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;e77#b77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ,electronic prior au?orization 7i7 ,9 g5]al ,n lat] ?an ,janu>y #a1 #bjba1 ! program %all provide = ! secure electronic transmission (-- 7,i7 a prior au?orization reque/ f ! prescrib+ heal? c>e pr(essional = cov]age ( a cov]$ "p ,d drug = a "p ,d eligible individual enroll$ 9 a "p ,d plan 7z def9$ 9 section #ahfj;,d-#bc7;a77#e77 to ! ,,pdp sponsor or ,m$ic>e ,advantage organization (f]+ su* plan2 & 7,,ii7 a response1 9 accordance ) ?is subp>agraph1 f su* ,,pdp sponsor or ,m$ic>e ,advantage organization1 respectively1 to su* pr(essional4 7ii7 ,electronic transmission 7,i7 ,exclusions ,= purposes ( ?is subp>agraph1 a facsimile1 a propriet>y pay] portal t does n meet /&>ds specifi$ by ! ,secret>y1 or an electronic =m %all n be treat$ z an electronic transmission describ$ 9 clause 7i74 7,,ii7 ,/&>ds ,9 ord] to be treat$1 = purposes ( ?is subp>agraph1 z an electronic transmission describ$ 9 clause 7i71 su* transmission %all comply ) te*nical /&>ds adopt$ by ! ,secret>y 9 consultation ) ! ,national ,c\ncil = ,prescription ,drug ,programs1 o!r /&>d sett+ organizations det]m9$ appropriate by ! ,secret>y1 & /akehold]s includ+ ,,pdp sponsors1 ,m$ic>e ,advantage organizations1 heal? c>e pr(essionals1 & heal? in=mation te*nology s(tw>e v5dors4 7,,iii7 ,application ,not)/&+ any o!r provision ( law1 = purposes ( ?is subp>agraph1 ! ,secret>y may require ! use ( su* /&>ds adopt$ "u subclause 7,,ii7 9 lieu ( any o!r applicable /&>ds = an electronic transmission describ$ 9 clause 7i7 = a cov]$ "p ,d drug = a "p ,d eligible individual4 4 7b7 ,s5se ( ,congress reg>d+ electronic prior au?orization ,x is ! s5se ( ! ,congress t-- 7#a7 !re %\ld be increas$ use ( electronic prior au?orizations = cov]age ( cov]$ "p ,d drugs = "p ,d eligible individuals enroll$ 9 prescription drug plans "u "p ,d ( title ,,xviii ( ! ,social ,security ,act & ,,ma-,,pd plans "u "p ,c ( su* title to r$uce access delays by resolv+ cov]age issues be=e prescriptions = su* drugs are transmitt$2 & 7#b7 great] priority %\ld be plac$ on increas+ ! adoption ( use ( su* electronic prior au?orizations among prescrib]s ( su* drugs1 ph>macies1 ,,pdp sponsors1 & ,m$ic>e ,advantage organizations4 #fjfc4 ,program integrity transp>5cy measures "u ,m$ic>e p>ts ,c & ,d 7a7 ,9 g5]al ,section #ahei ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bh7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7i7 ,program integrity transp>5cy measures 7#a7 ,program integrity portal 7,a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is subsection1 ! ,secret>y %all1 aft] consultation ) /akehold]s1 e/abli% a secure ,int]net website portal 7or o!r successor te*nology7 t w\ld all[ a secure pa? = communication betwe5 ! ,secret>y1 ,,ma plans "u ?is "p1 prescription drug plans "u "p ,d1 & an eligible entity ) a contract "u section #ahic 7su* z a ,m$ic>e drug integrity contractor or an entity responsible = c>ry+ out program integrity activities "u ?is "p & "p ,d7 = ! purpose ( enabl+ ?r\gh su* portal 7or o!r successor te*nology7-- 7i7 ! ref]ral by su* plans ( sub/antiat$ fraud1 wa/e1 & abuse = initiat+ or assi/+ inve/igations conduct$ by ! eligible entity2 & 7ii7 data %>+ among su* ,,ma plans1 prescription drug plans1 & ! ,secret>y4 7,b7 ,requir$ uses ( portal ,! ,secret>y %all dissem9ate ! foll[+ in=mation to ,,ma plans "u ?is "p & prescription drug plans "u "p ,d ?r\gh ! secure ,int]net website portal 7or o!r successor te*nology7 e/abli%$ "u subp>agraph 7,a73 7i7 ,provid]s ( s]vices & suppli]s t h be5 ref]r$ pursuant to subp>agraph 7,a77i7 dur+ ! previ\s #ab-mon? p]iod4 7ii7 ,provid]s ( s]vices & suppli]s :o are ! subject ( an active exclusion "u section #aabh or :o are subject to a susp5sion ( paym5t "u ?is title pursuant to section #ahfb7o7 or o!rwise4 7iii7 ,provid]s ( s]vices & suppli]s :o are ! subject ( an active revocation ( p>ticipation "u ?is title1 includ+ = n satisfy+ conditions ( p>ticipation4 7iv7 ,9 ! case ( su* a plan t makes a ref]ral "u subp>agraph 7,a77i7 ?r\gh ! portal 7or o!r successor te*nology7 ) respect to activities ( sub/antiat$ fraud1 wa/e1 or abuse ( a provid] ( s]vices or suppli]1 if su* provid] or suppli] has be5 ! subject ( an adm9i/rative action "u ?is title or title ,,xi ) respect to simil> activities1 a notification to su* plan ( su* action s tak54 7,c7 ,rulemak+ ,= purposes ( ?is p>agraph1 ! ,secret>y %all1 ?r\gh rulemak+1 specify :at con/itutes sub/antiat$ fraud1 wa/e1 & abuse1 us+ guidance su* z :at is provid$ 9 ! ,m$ic>e ,program ,integrity ,manual #d4g4a4 ,9 c>ry+ out ?is subsection1 a fraud hotl9e tip 7z def9$ by ! ,secret>y7 )\t fur!r evid5ce %all n be treat$ z suffici5t evid5ce = sub/antiat$ fraud1 wa/e1 or abuse4 7,d7 ,,hipaa compliant in=mation only ,= purposes ( ?is subsection1 communications may only occur if ! communications are p]mitt$ "u ! ,f$]al regulations 7conc]n+ ! privacy ( individually id5tifiable heal? in=mation7 promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif4 7#b7 ,qu>t]ly reports ,beg9n+ #b ye>s aft] ! date ( enactm5t ( ?is subsection1 ! ,secret>y %all make available to ,,ma plans "u ?is "p & prescription drug plans "u "p ,d 9 a timely mann] 7b no less frequ5tly ?an qu>t]ly7 & us+ in=mation submitt$ to an entity describ$ 9 p>agraph 7#a7 ?r\gh ! portal 7or o!r successor te*nology7 describ$ 9 su* p>agraph or pursuant to section #ahic1 in=mation on fraud1 wa/e1 & abuse s*emes & tr5ds 9 id5tify+ suspici\s activity4 ,in=mation includ$ 9 ea* su* report %all-- 7,a7 include adm9i/rative actions1 p]t95t in=mation relat$ to opioid ov]prescrib+1 & o!r data det]m9$ appropriate by ! ,secret>y 9 consultation ) /akehold]s2 & 7,b7 be anonymiz$ in=mation submitt$ by plans )\t id5tify+ ! s\rce ( su* in=mation4 7#c7 ,cl>ification ,no?+ 9 ?is subsection %all be con/ru$ z preclud+ or o!rwise affect+ ref]rals describ$ 9 subp>agraph 7,a7 t may o!rwise be made to law en=cem5t entities or to ! ,secret>y4 4 7b7 ,contract requirem5t to communicate plan corrective actions aga9/ opioid ov]-prescrib]s ,section #aheg7;e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;e77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#e7 ,communicat+ plan corrective actions aga9/ opioids ov]-prescrib]s 7,a7 ,9 g5]al ,beg9n+ ) plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjba1 a contract "u ?is section ) an ,,ma organization %all require ! organization to submit to ! ,secret>y1 ?r\gh ! process e/abli%$ "u subp>agraph 7,b71 in=mation on ! inve/igations & o!r actions tak5 by su* plans relat$ to provid]s ( s]vices :o prescribe a high volume ( opioids4 7,b7 ,process ,n lat] ?an ,janu>y #a1 #bjba1 ! ,secret>y %all1 9 consultation ) /akehold]s1 e/abli% a process "u :i* ,,ma plans & prescription drug plans %all submit to ! ,secret>y in=mation describ$ 9 subp>agraph 7,a74 7,c7 ,regulations ,= purposes ( ?is p>agraph1 includ+ z appli$ "u section #ahfj;,d-#ab7;b77#c77;,d71 ! ,secret>y %all1 pursuant to rulemak+-- 7i7 specify a def9ition = ! t]m high volume ( opioids & a me?od = det]m9+ if a provid] ( s]vices prescribes su* a high volume2 & 7ii7 e/abli% ! process describ$ 9 subp>agraph 7,b7 & ! types ( in=mation t %all be submitt$ ?r\gh su* process4 4 7c7 ,ref]5ce "u "p ,d to program integrity transp>5cy measures ,section #ahfj;,d-#d ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7m7 ,program integrity transp>5cy measures ,= program integrity transp>5cy measures appli$ ) respect to prescription drug plan & ,,ma plans1 see section #ahei7;i74 4 #fjfd4 ,exp&+ eligibility = m$ication !rapy managem5t programs "u "p ,d ,section #ahfj;,d-#d7;c77#b77;,a77ii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c77#b77;,a77ii77 is am5d$-- 7#a7 by r$esignat+ subclauses 7,i7 ?r\gh 7,,iii7 z items 7aa7 ?r\gh 7cc71 respectively1 & adju/+ ! m>g9s accord+ly2 7#b7 by /rik+ are "p ,d eligible individuals :o-- & ins]t+ are ! foll[+3 7,i7 ,"p ,d eligible individuals :o-- 2 & 7#c7 by add+ at ! end ! foll[+ new subclause3 7,,ii7 ,beg9n+ ,janu>y #a1 #bjba1 at-risk b5efici>ies = prescription drug abuse 7z def9$ 9 p>agraph 7#e77;,c774 4 #fjfe4 ,m$ic>e notifications to outli] prescrib]s ( opioids ,section #ahfj;,d-#d7;c77#d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c77#d77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,d7 ,outli] prescrib] notification 7i7 ,notification ,beg9n+ n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is subp>agraph1 ! ,secret>y %all1 9 ! case ( a prescrib] id5tifi$ by ! ,secret>y "u clause 7ii7 to be an outli] prescrib] ( opioids1 provide1 subject to clause 7iv71 an annual notification to su* prescrib] t su* prescrib] has be5 s id5tifi$ & t includes res\rces on prop] prescrib+ me?ods & o!r in=mation specifi$ 9 accordance ) clause 7iii74 7ii7 ,id5tification ( outli] prescrib]s ( opioids 7,i7 ,9 g5]al ,! ,secret>y %all1 subject to subclause 7,,iii71 us+ ! valid prescrib] ,national ,provid] ,id5tifi]s includ$ pursuant to subp>agraph 7,a7 on claims = cov]$ "p ,d drugs = "p ,d eligible individuals enroll$ 9 prescription drug plans "u ?is "p or ,,ma-,,pd plans "u "p ,c & bas$ on ! ?re%old e/abli%$ "u subclause 7,,ii71 conduct an analysis to id5tify prescrib]s t are outli] opioid prescrib]s = a p]iod specifi$ by ! ,secret>y4 7,,ii7 ,e/abli%m5t ( ?re%old ,= purposes ( subclause 7,i7 & subject to subclause 7,,iii71 ! ,secret>y %all1 aft] consultation ) /akehold]s1 e/abli% a ?re%old1 bas$ on prescrib] specialty & geographic area1 = id5tify+ :e!r a prescrib] 9 a specialty & geographic area is an outli] prescrib] ( opioids z comp>$ to o!r prescrib]s ( opioids )9 su* specialty & area4 7,,iii7 ,exclusions ,! ,secret>y may exclude ! foll[+ individuals & prescrib]s f ! analysis "u ?is clause3 7aa7 ,individuals receiv+ hospice s]vices4 7bb7 ,individuals ) a canc] diagnosis4 7cc7 ,prescrib]s :o are ! subject ( an inve/igation by ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices or ! ,(fice ( ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7iii7 ,cont5ts ( notification ,! ,secret>y %all1 bas$ on input f /akehold]s1 specify ! res\rces & o!r in=mation to be includ$ 9 notifications provid$ "u clause 7i74 7iv7 ,modifications & expansions 7,i7 ,frequ5cy ,beg9n+ #e ye>s aft] ! date ( ! enactm5t ( ?is subp>agraph1 ! ,secret>y may *ange ! frequ5cy ( ! notifications describ$ 9 clause 7i7 bas$ on /akehold] input4 7,,ii7 ,expansion to o!r prescriptions ,! ,secret>y may exp& notifications "u ?is subp>agraph to include id5tifications & notifications ) respect to concurr5t prescriptions ( cov]$ ,"p ,d drugs us$ 9 comb9ation ) opioids t are consid]$ to h adv]se side effects :5 s us$ 9 su* comb9ation1 z det]m9$ by ! ,secret>y4 7v7 ,opioids def9$ ,= purposes ( ?is subp>agraph1 ! t]m opioids has su* mean+ z specifi$ by ! ,secret>y ?r\gh program in/ruction or o!rwise4 4 #fjff4 ,no additional funds au?oriz$ ,no additional funds are au?oriz$ to be appropriat$ to c>ry out ! requirem5ts ( ?is subtitle & ! am5dm5ts made by ?is subtitle4 ,su* requirem5ts %all be c>ri$ out us+ am\nts o!rwise au?oriz$ to be appropriat$4 ,h ,exp&+ ,ov]sight ( ,opioid ,prescrib+ & ,paym5t #fjga4 ,%ort title ,?is subtitle may be cit$ z ! ,exp&+ ,ov]sight ( ,opioid ,prescrib+ & ,paym5t ,act ( #bjah4 #fjgb4 ,m$ic>e ,paym5t ,advisory ,commission report on opioid paym5t1 adv]se inc5tives1 & data "u ! ,m$ic>e program ,n lat] ?an ,m>* #ae1 #bjai1 ! ,m$ic>e ,paym5t ,advisory ,commission %all submit to ,congress a report on1 ) respect to ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act1 ! foll[+3 7#a7 ,a description ( h[ ! ,m$ic>e program pays = pa9 managem5t treatm5ts 7bo? opioid & non-opioid pa9 managem5t alt]natives7 9 bo? inpati5t & outpati5t hospital sett+s4 7#b7 ,! id5tification ( inc5tives "u ! hospital inpati5t prospective paym5t sy/em "u section #ahhf ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7 & inc5tives "u ! hospital outpati5t prospective paym5t sy/em "u section #ahcc7t7 ( su* ,act 7#db ,u4,s4,c4 #aciel7t77 = prescrib+ opioids & inc5tives "u ea* su* sy/em = prescrib+ non-opioid treatm5ts1 & recomm5dations z ! ,commission deems appropriate = address+ any ( su* inc5tives t are adv]se inc5tives4 7#c7 ,a description ( h[ opioid use is track$ & monitor$ ?r\gh ,m$ic>e claims data & o!r me*anisms & ! id5tification ( any areas 9 :i* fur!r data & me?ods are ne$$ = improv+ data & und]/&+ ( opioid use4 #fjgc4 ,no additional funds au?oriz$ ,no additional funds are au?oriz$ to be appropriat$ to c>ry out ! requirem5ts ( ?is subtitle4 ,su* requirem5ts %all be c>ri$ out us+ am\nts o!rwise au?oriz$ to be appropriat$4 ,i ,dr4 ,todd ,graham ,pa9 ,managem5t1 ,treatm5t1 & ,recov]y #fjha4 ,%ort title ,?is subtitle may be cit$ z ! ,dr4 ,todd ,graham ,pa9 ,managem5t1 ,treatm5t1 & ,recov]y ,act ( #bjah4 #fjhb4 ,review & adju/m5t ( paym5ts "u ! ,m$ic>e outpati5t prospective paym5t sy/em to avoid f9ancial inc5tives to use opioids in/ead ( non-opioid alt]native treatm5ts 7a7 ,outpati5t prospective paym5t sy/em ,section #ahcc7t7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#bb7 ,review & revisions ( paym5ts = non-opioid alt]native treatm5ts 7,a7 ,9 g5]al ,) respect to paym5ts made "u ?is subsection = cov]$ ,,opd s]vices 7or gr\ps ( s]vices71 includ+ cov]$ ,,opd s]vices assign$ to a compreh5sive ambulatory paym5t classification1 ! ,secret>y-- 7i7 %all1 z soon z practicable1 conduct a review 7"p ( :i* may include a reque/ = in=mation7 ( paym5ts = opioids & evid5ce-bas$ non-opioid alt]natives = pa9 managem5t 7includ+ drugs & devices1 n]ve blocks1 surgical injections1 & neuromodulation7 ) a goal ( ensur+ t !re are n f9ancial inc5tives to use opioids in/ead ( non-opioid alt]natives2 7ii7 may1 z ! ,secret>y det]m9es appropriate1 conduct subsequ5t reviews ( su* paym5ts2 & 7iii7 %all consid] ! ext5t to :i* revisions "u ?is subsection to su* paym5ts 7su* z ! creation ( additional gr\ps ( cov]$ ,,opd s]vices to classify sep>ately ^? proc$ures t utilize opioids & non-opioid alt]natives = pa9 managem5t7 w\ld r$uce paym5t inc5tives to use opioids in/ead ( non-opioid alt]natives = pa9 managem5t4 7,b7 ,priority ,9 conduct+ ! review "u clause 7i7 ( subp>agraph 7,a7 & consid]+ revisions "u clause 7iii7 ( su* subp>agraph1 ! ,secret>y %all focus on cov]$ ,,opd s]vices 7or gr\ps ( s]vices7 assign$ to a compreh5sive ambulatory paym5t classification1 ambulatory paym5t classifications t prim>ily include surgical s]vices1 & o!r s]vices det]m9$ by ! ,secret>y :i* g5]ally involve treatm5t = pa9 managem5t4 7,c7 ,revisions ,if ! ,secret>y id5tifies revisions to paym5ts pursuant to subp>agraph 7,a77iii71 ! ,secret>y %all1 z det]m9$ appropriate1 beg9 mak+ su* revisions = s]vices furni%$ on or aft] ,janu>y #a1 #bjbj4 ,revisions "u ! previ\s s5t5ce %all be treat$ z adju/m5ts = purposes ( application ( p>agraph 7#i77;,b74 7,d7 ,rules ( con/ruction ,no?+ 9 ?is p>agraph %all be con/ru$ to preclude ! ,secret>y-- 7i7 f conduct+ a demon/ration be=e mak+ ! revisions describ$ 9 subp>agraph 7,c72 or 7ii7 prior to implem5tation ( ?is p>agraph1 f *ang+ paym5ts "u ?is subsection = cov]$ ,,opd s]vices 7or gr\ps ( s]vices7 :i* include opioids or non-opioid alt]natives = pa9 managem5t4 4 7b7 ,ambulatory surgical c5t]s ,section #ahcc7;i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7i77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#h7 ,! ,secret>y %all conduct a simil> type ( review z requir$ "u p>agraph 7#bb7 ( section #ahcc7t771 includ+ ! second s5t5ce ( subp>agraph 7,c7 ( su* p>agraph1 to paym5t = s]vices "u ?is subsection1 & make su* revisions "u ?is p>agraph1 9 an appropriate mann] 7z det]m9$ by ! ,secret>y74 4 #fjhc4 ,exp&+ access "u ! ,m$ic>e program to addiction treatm5t 9 ,f$]ally qualifi$ heal? c5t]s & rural heal? cl9ics 7a7 ,f$]ally qualifi$ heal? c5t]s ,section #ahcd7o7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7o77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#c7 ,additional paym5ts = c]ta9 ,f,q,h,cs ) physicians or o!r practition]s receiv+ ,,data #bjjj waiv]s 7,a7 ,9 g5]al ,9 ! case ( a ,f$]ally qualifi$ heal? c5t] ) respect to :i*1 beg9n+ on or aft] ,janu>y #a1 #bjai1 ,f$]ally-qualifi$ heal? c5t] s]vices 7z def9$ 9 section #ahfa7;aa77#c77 are furni%$ = ! treatm5t ( opioid use disord] by a physician or practition] :o meets ! requirem5ts describ$ 9 subp>agraph 7,c7 ! ,secret>y %all1 subject to availability ( funds "u subp>agraph 7,d71 make a paym5t 7at su* "t & 9 su* mann] z specifi$ by ! ,secret>y7 to su* ,f$]ally qualifi$ heal? c5t] aft] receiv+ & approv+ an application submitt$ by su* ,f$]ally qualifi$ heal? c5t] "u subp>agraph 7,b74 ,su* a paym5t %all be 9 an am\nt det]m9$ by ! ,secret>y1 bas$ on an e/imate ( ! av]age co/s ( tra9+ = purposes ( receiv+ a waiv] describ$ 9 subp>agraph 7,c77ii74 ,su* a paym5t may be made only "o "t ) respect to ea* su* physician or practition]4 7,b7 ,application ,9 ord] to receive a paym5t describ$ 9 subp>agraph 7,a71 a ,f$]ally-qualifi$ heal? c5t] %all submit to ! ,secret>y an application = su* a paym5t at su* "t1 9 su* mann]1 & conta9+ su* in=mation z specifi$ by ! ,secret>y4 ,a ,f$]ally-qualifi$ heal? c5t] may apply = su* a paym5t = ea* physician or practition] describ$ 9 subp>agraph 7,a7 furni%+ s]vices describ$ 9 su* subp>agraph at su* c5t]4 7,c7 ,requirem5ts ,= purposes ( subp>agraph 7,a71 ! requirem5ts describ$ 9 ?is subp>agraph1 ) respect to a physician or practition]1 are ! foll[+3 7i7 ,! physician or practition] is employ$ by or work+ "u contract ) a ,f$]ally qualifi$ heal? c5t] describ$ 9 subp>agraph 7,a7 t submits an application "u subp>agraph 7,b74 7ii7 ,! physician or practition] fir/ receives a waiv] "u section #cjc7;g7 ( ! ,controll$ ,sub/ances ,acton or aft] ,janu>y #a1 #bjai4 7,d7 ,fund+ ,= purposes ( mak+ paym5ts "u ?is p>agraph1 !re are appropriat$1 out ( am\nts 9 ! ,treasury n o!rwise appropriat$1 #f1jjj1jjj1 :i* %all rema9 available until exp5d$4 4 7b7 ,rural heal? cl9ic ,section #ahcc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7 is am5d$-- 7#a7 by r$esignat+ ! subsection 7z7 relat+ to m$ical review ( sp9al subluxation s]vices z subsection 7aa72 & 7#b7 by add+ at ! end ! foll[+ new subsection3 7bb7 ,additional paym5ts = c]ta9 rural heal? cl9ics ) physicians or practition]s receiv+ ,,data #bjjj waiv]s 7#a7 ,9 g5]al ,9 ! case ( a rural heal? cl9ic ) respect to :i*1 beg9n+ on or aft] ,janu>y #a1 #bjai1 rural heal? cl9ic s]vices 7z def9$ 9 section #ahfa7;aa77#a77 are furni%$ = ! treatm5t ( opioid use disord] by a physician or practition] :o meets ! requirem5ts describ$ 9 p>agraph 7#c71 ! ,secret>y %all1 subject to availability ( funds "u p>agraph 7#d71 make a paym5t 7at su* "t & 9 su* mann] z specifi$ by ! ,secret>y7 to su* rural heal? cl9ic aft] receiv+ & approv+ an application describ$ 9 p>agraph 7#b74 ,su* paym5t %all be 9 an am\nt det]m9$ by ! ,secret>y1 bas$ on an e/imate ( ! av]age co/s ( tra9+ = purposes ( receiv+ a waiv] describ$ 9 p>agraph 7#c77;,b74 ,su* paym5t may be made only "o "t ) respect to ea* su* physician or practition]4 7#b7 ,application ,9 ord] to receive a paym5t describ$ 9 p>agraph 7#a71 a rural heal? cl9ic %all submit to ! ,secret>y an application = su* a paym5t at su* "t1 9 su* mann]1 & conta9+ su* in=mation z specifi$ by ! ,secret>y4 ,a rural heal? cl9ic may apply = su* a paym5t = ea* physician or practition] describ$ 9 p>agraph 7#a7 furni%+ s]vices describ$ 9 su* p>agraph at su* cl9ic4 7#c7 ,requirem5ts ,= purposes ( p>agraph 7#a71 ! requirem5ts describ$ 9 ?is p>agraph1 ) respect to a physician or practition]1 are ! foll[+3 7,a7 ,! physician or practition] is employ$ by or work+ "u contract ) a rural heal? cl9ic describ$ 9 p>agraph 7#a7 t submits an application "u p>agraph 7#b74 7,b7 ,! physician or practition] fir/ receives a waiv] "u section #cjc7;g7 ( ! ,controll$ ,sub/ances ,acton or aft] ,janu>y #a1 #bjai4 7#d7 ,fund+ ,= purposes ( mak+ paym5ts "u ?is subsection1 !re are appropriat$1 out ( am\nts 9 ! ,treasury n o!rwise appropriat$1 #b1jjj1jjj1 :i* %all rema9 available until exp5d$4 4 #fjhd4 ,/udy+ ! availability ( supplem5tal b5efits design$ to treat or prev5t sub/ance use disord]s "u ,m$ic>e ,advantage plans 7a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 %all submit to ,congress a report on ! availability ( supplem5tal heal? c>e b5efits 7z describ$ 9 section #aheb7;a77#c77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bb7;a77#c77;,a777 design$ to treat or prev5t sub/ance use disord]s "u ,m$ic>e ,advantage plans (f]$ "u "p ,c ( title ,,xviii ( su* ,act4 ,su* report %all include ! analysis describ$ 9 subsection 7c7 & any diff]5ces 9 ! availability ( su* b5efits "u specializ$ ,,ma plans = special ne$s individuals 7z def9$ 9 section #ahei7;b77#f7 ( su* ,act 7#db ,u4,s4,c4 #aciew-#bh7;b77#f777 (f]$ to individuals entitl$ to m$ical assi/ance "u title ,,xix ( su* ,act & o!r su* ,m$ic>e ,advantage plans4 7b7 ,consultation ,! ,secret>y %all develop ! report describ$ 9 subsection 7a7 9 consultation ) relevant /akehold]s1 includ+-- 7#a7 individuals entitl$ to b5efits "u "p ,a or enroll$ "u "p ,b ( title ,,xviii ( ! ,social ,security ,act2 7#b7 entities :o advocate on behalf ( su* individuals2 7#c7 ,m$ic>e ,advantage organizations2 7#d7 ph>macy b5efit manag]s2 & 7#e7 provid]s ( s]vices & suppli]s 7z su* t]ms are def9$ 9 section #ahfa ( su* ,act 7#db ,u4,s4,c4 #aciex774 7c7 ,cont5ts ,! report describ$ 9 subsection 7a7 %all include an analysis on ! foll[+3 7#a7 ,! ext5t to :i* plans describ$ 9 su* subsection (f] supplem5tal heal? c>e b5efits relat+ to cov]age (-- 7,a7 m$ication-assi/$ treatm5ts = opioid use1 sub/ance use disord] c\nsel+1 pe] recov]y support s]vices1 or o!r =ms ( sub/ance use disord] treatm5ts 7:e!r furni%$ 9 an inpati5t or outpati5t sett+72 & 7,b7 non-opioid alt]natives = ! treatm5t ( pa94 7#b7 ,*all5ges associat$ ) su* plans (f]+ supplem5tal heal? c>e b5efits relat+ to cov]age ( items & s]vices describ$ 9 subp>agraph 7,a7 or 7,b7 ( p>agraph 7#a74 7#c7 ,! impact1 if any1 ( increas+ ! applicable rebate p]c5tage det]m9$ "u section #ahed7;b77#a77;,c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bd7;b77#a77;,c77 = plans (f]+ su* b5efits relat+ to su* cov]age w\ld h on ! availability ( su* b5efits relat+ to su* cov]age (f]$ "u ,m$ic>e ,advantage plans4 7#d7 ,pot5tial ways to improve ^u su* cov]age or to inc5tivize su* plans to (f] additional supplem5tal heal? c>e b5efits relat+ to su* cov]age4 #fjhe4 ,cl9ical psy*ologi/ s]vices models "u ! ,c5t] = ,m$ic>e & ,m$icaid ,innovation2 ,,gao /udy & report 7a7 ,,cmi models ,section #aaae;,a7b77#b77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acae;a7b77#b77;,b7 is am5d$ by add+ at ! end ! foll[+ new clauses3 7xxv7 ,support+ ways to famili>ize individuals ) ! availability ( cov]age "u "p ,b ( title ,,xviii = qualifi$ psy*ologi/ s]vices 7z def9$ 9 section #ahfa7;ii774 7xxvi7 ,explor+ ways to avoid unnecess>y hospitalizations or em]g5cy dep>tm5t visits = m5tal & behavioral heal? s]vices 7su* z = treat+ depression7 ?r\gh use ( a #bd-;h\r1 #g-;day a week help l9e t may in=m individuals ab\t ! availability ( treatm5t options1 includ+ ! availability ( qualifi$ psy*ologi/ s]vices 7z def9$ 9 section #ahfa7;ii774 4 7b7 ,,gao /udy & report ,n lat] ?an #ah mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy1 & submit to ,congress a report1 on m5tal & behavioral heal? s]vices "u ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act1 includ+ an exam9ation ( ! foll[+3 7#a7 ,in=mation ab\t s]vices furni%$ by psy*iatri/s1 cl9ical psy*ologi/s1 & o!r pr(essionals4 7#b7 ,in=mation ab\t ways t ,m$ic>e b5efici>ies famili>ize !mselves ab\t ! availability ( ,m$ic>e paym5t = qualifi$ psy*ologi/ s]vices 7z def9$ 9 section #ahfa7;ii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7ii77 & ways t ! provision ( su* in=mation c\ld be improv$4 #fjhf4 ,pa9 managem5t /udy 7a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! 8,secret>y07 %all conduct a /udy analyz+ be/ practices z well z paym5t & cov]age = pa9 managem5t s]vices "u title ,,xviii ( ! ,social ,security ,act & submit to ! ,committee on ,ways & ,means & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,f9ance ( ! ,s5ate a report conta9+ options = revis+ paym5t to provid]s & suppli]s ( s]vices & cov]age relat$ to ! use ( multi-discipl9>y1 evid5ce-bas$1 non-opioid treatm5ts = acute & *ronic pa9 managem5t = individuals entitl$ to b5efits "u "p ,a or enroll$ "u "p ,b ( title ,,xviii ( ! ,social ,security ,act4 ,! ,secret>y %all make su* report available on ! public website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 7b7 ,consultation ,9 develop+ ! report describ$ 9 subsection 7a71 ! ,secret>y %all consult )-- 7#a7 relevant ag5cies )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices2 7#b7 lic5s$ & practic+ o/eopa?ic & allopa?ic physicians1 behavioral heal? practition]s1 physician assi/ants1 nurse practition]s1 d5ti/s1 ph>maci/s1 & o!r provid]s ( heal? s]vices2 7#c7 provid]s & suppli]s ( s]vices 7z su* t]ms are def9$ 9 section #ahfa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex772 7#d7 sub/ance abuse & m5tal heal? pr(essional organizations2 7#e7 pa9 managem5t pr(essional organizations & advocacy entities1 includ+ individuals :o p]sonally suff] *ronic pa92 7#f7 m$ical pr(essional organizations & m$ical specialty organizations2 7#g7 lic5s$ heal? c>e provid]s :o furni% alt]native pa9 managem5t s]vices2 7#h7 organizations ) exp]tise 9 ! developm5t ( innovative m$ical te*nologies = pa9 managem5t2 7#i7 b5efici>y advocacy organizations2 & 7#aj7 o!r organizations ) exp]tise 9 ! assessm5t1 diagnosis1 treatm5t1 & managem5t ( pa91 z det]m9$ appropriate by ! ,secret>y4 7c7 ,cont5ts ,! report describ$ 9 subsection 7a7 %all include ! foll[+3 7#a7 ,an analysis ( paym5t & cov]age "u title ,,xviii ( ! ,social ,security ,act ) respect to ! foll[+3 7,a7 ,evid5ce-bas$ treatm5ts & te*nologies = *ronic or acute pa91 includ+ su* treatm5ts t are cov]$1 n cov]$1 or h limit$ cov]age "u su* title4 7,b7 ,evid5ce-bas$ treatm5ts & te*nologies t monitor sub/ance use )drawal & prev5t ov]doses ( opioids4 7,c7 ,evid5ce-bas$ treatm5ts & te*nologies t treat sub/ance use disord]s4 7,d7 ,items & s]vices furni%$ by practition]s ?r\gh a multi-discipl9>y treatm5t model = pa9 managem5t1 includ+ ! pati5t-c5t]$ m$ical home4 7,e7 ,m$ical devices1 non-opioid bas$ drugs1 & o!r !rapies 7includ+ int]v5tional & integrative pa9 !rapies7 approv$ or cle>$ by ! ,food & ,drug ,adm9i/ration = ! treatm5t ( pa94 7,f7 ,items & s]vices furni%$ to b5efici>ies ) psy*iatric disord]s1 sub/ance use disord]s1 or :o are at risk ( suicide1 or h comorbidities & require consultation or managem5t ( pa9 ) "o or m speciali/s 9 pa9 managem5t1 m5tal heal?1 or addiction treatm5t4 7#b7 ,an evaluation ( ! foll[+3 7,a7 ,b>ri]s inhibit+ individuals entitl$ to b5efits "u "p ,a or enroll$ "u "p ,b ( su* title f access+ treatm5ts & te*nologies describ$ 9 subp>agraphs 7,a7 ?r\gh 7,f7 ( p>agraph 7#a74 7,b7 ,co/s & b5efits associat$ ) pot5tial expansion ( cov]age "u su* title to include items & s]vices n cov]$ "u su* title t may be us$ = ! treatm5t ( pa91 su* z acupuncture1 !rapeutic massage1 & items & s]vices furni%$ by integrat$ pa9 managem5t programs4 7,c7 ,pa9 managem5t guidance publi%$ by ! ,f$]al ,gov]nm5t t may be relevant to cov]age det]m9ations or o!r cov]age requirem5ts "u title ,,xviii ( ! ,social ,security ,act4 7#c7 ,an assessm5t ( all guidance publi%$ by ! ,dep>tm5t ( ,heal? & ,human ,s]vices on or aft] ,janu>y #a1 #bjaf1 relat+ to ! prescrib+ ( opioids4 ,su* assessm5t %all consid] incorporat+ into su* guidance relevant elem5ts ( ! ,va_/,do,d ,cl9ical ,practice ,guidel9e = ,opioid ,!rapy = ,*ronic ,pa9 publi%$ 9 ,febru>y #bjag by ! ,dep>tm5t ( ,vet]ans ,affairs & ,dep>tm5t ( ,def5se1 includ+ adoption ( elem5ts ( ! ,dep>tm5t ( ,def5se & ,dep>tm5t ( ,vet]ans ,affairs pa9 rat+ scale4 7#d7 ,! options describ$ 9 subsection 7d74 7#e7 ,! impact analysis describ$ 9 subsection 7e74 7d7 ,options ,! options describ$ 9 ?is subsection are1 ) respect to individuals entitl$ to b5efits "u "p ,a or enroll$ "u "p ,b ( title ,,xviii ( ! ,social ,security ,act1 legislative & adm9i/rative options = accompli%+ ! foll[+3 7#a7 ,improv+ cov]age ( & paym5t = pa9 managem5t !rapies )\t ! use ( opioids1 includ+ int]v5tional pa9 !rapies1 & options to augm5t opioid !rapy ) o!r cl9ical & complem5t>y1 integrative heal? s]vices to m9imize ! risk ( sub/ance use disord]1 includ+ 9 a hospital sett+4 7#b7 ,improv+ cov]age ( & paym5t = m$ical devices & non-opioid bas$ ph>macological & non-ph>macological !rapies approv$ or cle>$ by ! ,food & ,drug ,adm9i/ration = ! treatm5t ( pa9 z an alt]native or augm5t to opioid !rapy4 7#c7 ,improv+ & dissem9at+ treatm5t /rategies = b5efici>ies ) psy*iatric disord]s1 sub/ance use disord]s1 or :o are at risk ( suicide1 & treatm5t /rategies to address heal? disp>ities relat$ to opioid use & opioid abuse treatm5t4 7#d7 ,improv+ & dissem9at+ treatm5t /rategies = b5efici>ies ) comorbidities :o require a consultation or comanagem5t ( pa9 ) "o or m speciali/s 9 pa9 managem5t1 m5tal heal?1 or addiction treatm5t1 includ+ 9 a hospital sett+4 7#e7 ,educat+ provid]s on risks ( coadm9i/ration ( opioids & o!r drugs1 p>ticul>ly b5zodiazep9es4 7#f7 ,ensur+ appropriate case managem5t = b5efici>ies :o transition betwe5 inpati5t & outpati5t hospital sett+s1 or betwe5 opioid !rapy to non-opioid !rapy1 :i* may include ! use ( c>e transition plans4 7#g7 ,exp&+ outrea* activities design$ to educate provid]s ( s]vices & suppli]s "u ! ,m$ic>e program & individuals entitl$ to b5efits "u "p ,a or "u "p ,b ( su* title on alt]native1 non-opioid !rapies to manage & treat acute & *ronic pa94 7#h7 ,creat+ a b5efici>y education tool on alt]natives to opioids = *ronic pa9 managem5t4 7e7 ,impact analysis ,! impact analysis describ$ 9 ?is subsection consi/s ( an analysis ( any pot5tial effects implem5t+ ! options describ$ 9 subsection 7d7 w\ld h-- 7#a7 on exp5ditures "u ! ,m$ic>e program2 & 7#b7 on prev5t+ or r$uc+ opioid addiction = individuals receiv+ b5efits "u ! ,m$ic>e program4 ,j ,combat+ ,opioid ,abuse = ,c>e 9 ,hospitals #fjia4 ,%ort title ,?is subtitle may be cit$ z ! ,combat+ ,opioid ,abuse = ,c>e 9 ,hospitals ,act ( #bjah or ! ,,coa* ,act ( #bjah4 #fjib4 ,develop+ guidance on pa9 managem5t & opioid use disord] prev5tion = hospitals receiv+ paym5t "u "p ,a ( ! ,m$ic>e program 7a7 ,9 g5]al ,n lat] ?an ,janu>y #a1 #bjai1 ! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 %all develop & publi% on ! public website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices guidance = hospitals receiv+ paym5t "u "p ,a ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;c et seq47 on pa9 managem5t /rategies & opioid use disord] prev5tion /rategies ) respect to individuals entitl$ to b5efits "u su* "p4 7b7 ,consultation ,9 develop+ ! guidance describ$ 9 subsection 7a71 ! ,secret>y %all consult ) relevant /akehold]s1 includ+-- 7#a7 m$ical pr(essional organizations2 7#b7 provid]s & suppli]s ( s]vices 7z su* t]ms are def9$ 9 section #ahfa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex772 7#c7 heal? c>e consum]s or gr\ps repres5t+ su* consum]s2 & 7#d7 o!r entities det]m9$ appropriate by ! ,secret>y4 7c7 ,cont5ts ,! guidance describ$ 9 subsection 7a7 %all include1 ) respect to hospitals & individuals describ$ 9 su* subsection1 ! foll[+3 7#a7 ,be/ practices reg>d+ evid5ce-bas$ scre5+ & practition] education initiatives relat+ to scre5+ & treatm5t protocols = opioid use disord]1 includ+-- 7,a7 me?ods to id5tify su* individuals at-risk ( opioid use disord]1 includ+ risk /ratification2 7,b7 ways to prev5t1 recognize1 & treat opioid ov]doses2 & 7,c7 res\rces available to su* individuals1 su* z opioid treatm5t programs1 pe] support gr\ps1 & o!r recov]y programs4 7#b7 ,be/ practices = su* hospitals to educate practition]s furni%+ items & s]vices at su* hospital ) respect to pa9 managem5t & sub/ance use disord]s1 includ+ education on-- 7,a7 ! adv]se effects ( prolong$ opioid use2 7,b7 non-opioid1 evid5ce-bas$1 non-ph>macological pa9 managem5t treatm5ts2 7,c7 monitor+ programs = individuals :o h be5 prescrib$ opioids2 & 7,d7 ! prescrib+ ( naloxone along ) an initial opioid prescription4 7#c7 ,be/ practices = su* hospitals to make su* individuals aw>e ( ! risks associat$ ) opioid use 7:i* may include use ( ! notification template describ$ 9 p>agraph 7#d774 7#d7 ,a notification template develop$ by ! ,secret>y1 = use z appropriate1 = su* individuals :o are prescrib$ an opioid t-- 7,a7 expla9s ! risks & side effects associat$ ) opioid use 7includ+ ! risks ( addiction & ov]dose7 & ! importance ( adh]+ to ! prescrib$ treatm5t regim51 avoid+ m$ications t may h an adv]se int]action ) su* opioid1 & /or+ su* opioid safely & securely2 7,b7 highlights multimodal & evid5ce-bas$ non-opioid alt]natives = pa9 managem5t2 7,c7 enc\rages su* individuals to talk to _! heal? c>e provid]s ab\t su* alt]natives2 7,d7 provides = a me?od 7?r\gh signature or o!rwise7 = su* an individual1 or p]son act+ on su* individual's behalf1 to ackn[l$ge receipt ( su* notification template2 7,e7 is word$ 9 an easily und]/&able mann] & made available 9 multiple languages det]m9$ appropriate by ! ,secret>y2 & 7,f7 includes any o!r in=mation det]m9$ appropriate by ! ,secret>y4 7#e7 ,be/ practices = su* hospital to track opioid prescrib+ tr5ds by practition]s furni%+ items & s]vices at su* hospital1 includ+-- 7,a7 ways = su* hospital to e/abli% t>get levels1 tak+ into acc\nt ! specialties ( su* practition]s & ! geographic area 9 :i* su* hospital is locat$1 ) respect to opioids prescrib$ by su* practition]s2 7,b7 guidance on *eck+ ! m$ical records ( su* individuals aga9/ in=mation includ$ 9 prescription drug monitor+ programs2 7,c7 /rategies to r$uce long-t]m opioid prescriptions2 & 7,d7 me?ods to id5tify su* practition]s :o may be ov]-prescrib+ opioids4 7#f7 ,o!r in=mation ! ,secret>y det]m9es appropriate1 includ+ any su* in=mation f ! ,opioid ,safety ,initiative e/abli%$ by ! ,dep>tm5t ( ,vet]ans ,affairs or ! ,opioid ,ov]dose ,prev5tion ,toolkit publi%$ by ! ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration4 #fjic4 ,requir+ ! review ( quality measures relat+ to opioids & opioid use disord] treatm5ts furni%$ "u ! m$ic>e program & o!r f$]al heal? c>e programs 7a7 ,9 g5]al ,section #ahij;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;aaa-#a7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7g7 ,te*nical exp]t panel review ( opioid & opioid use disord] quality measures 7#a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is subsection1 ! ,secret>y %all e/abli% a te*nical exp]t panel = purposes ( review+ quality measures relat+ to opioids & opioid use disord]s1 includ+ c>e1 prev5tion1 diagnosis1 heal? outcomes1 & treatm5t furni%$ to individuals ) opioid use disord]s4 ,! ,secret>y may use ! entity ) a contract "u section #ahij7;a7 & am5d su* contract z necess>y to provide = ! e/abli%m5t ( su* te*nical exp]t panel4 7#b7 ,review & assessm5t ,n lat] ?an #a ye> aft] ! date ! te*nical exp]t panel describ$ 9 p>agraph 7#a7 is e/abli%$ 7& p]iodically !reaft] z ! ,secret>y det]m9es appropriate71 ! te*nical exp]t panel %all-- 7,a7 review quality measures t relate to opioids & opioid use disord]s1 includ+ exi/+ measures & ^? "u developm5t2 7,b7 id5tify gaps 9 areas ( quality measurem5t t relate to opioids & opioid use disord]s1 & id5tify measure developm5t priorities = su* measure gaps2 & 7,c7 make recomm5dations to ! ,secret>y on quality measures ) respect to opioids & opioid use disord]s = purposes ( improv+ c>e1 prev5tion1 diagnosis1 heal? outcomes1 & treatm5t1 includ+ recomm5dations = revisions ( su* measures1 ne$ = developm5t ( new measures1 & recomm5dations = includ+ su* measures 9 ! ,m]it-,bas$ ,inc5tive ,paym5t ,sy/em "u section #ahdh7q71 ! alt]native paym5t models "u section #ahcc7z77#c77;,c71 ! %>$ sav+s program "u section #ahii1 ! quality report+ requirem5ts = inpati5t hospitals "u section #ahhf7;b77#c77;,b77viii71 & ! hospital value-bas$ pur*as+ program "u section #ahhf7o74 7#c7 ,consid]ation ( measures by secret>y ,! ,secret>y %all consid]-- 7,a7 us+ opioid & opioid use disord] measures 7includ+ measures us$ "u ! ,m]it-,bas$ ,inc5tive ,paym5t ,sy/em "u section #ahdh7q71 measures recomm5d$ "u p>agraph 7#b77;,c71 & o!r su* measures id5tifi$ by ! ,secret>y7 9 alt]native paym5t models "u section #ahcc7z77#c77;,c7 & 9 ! %>$ sav+s program "u section #ahii2 & 7,b7 us+ opioid measures describ$ 9 subp>agraph 7,a71 z applicable1 9 ! quality report+ requirem5ts = inpati5t hospitals "u section #ahhf7;b77#c77;,b77viii71& 9 ! hospital value-bas$ pur*as+ program "u section #ahhf7o74 7#d7 ,prioritization ( measure developm5t ,! ,secret>y %all prioritize = measure developm5t ! gaps 9 quality measures id5tifi$ "u p>agraph 7#b77;,b74 4 7b7 ,exp$it$ endorsem5t process = opioid measures ,section #ahij7;b77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;aaa7b77#b77 is am5d$ by add+ at ! end ! foll[+ new flu% s5t5ce3 ,su* endorsem5t process %all1 z det]m9$ practicable by ! entity1 provide = an exp$it$ process ) respect to ! endorsem5t ( su* measures relat+ to opioids & opioid use disord]s4 4 #fjid4 ,te*nical exp]t panel on r$uc+ surgical sett+ opioid use2 ,data collection on p]iop]ative opioid use 7a7 ,te*nical exp]t panel on r$uc+ surgical sett+ opioid use 7#a7 ,9 g5]al ,n lat] ?an #f mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all conv5e a te*nical exp]t panel1 includ+ m$ical & surgical specialty societies & hospital organizations1 to provide recomm5dations on r$uc+ opioid use 9 ! inpati5t & outpati5t surgical sett+s & on be/ practices = pa9 managem5t1 includ+ ) respect to ! foll[+3 7,a7 ,approa*es t limit pati5t exposure to opioids dur+ ! p]iop]ative p]iod1 includ+ pre-surgical & po/-surgical injections1 & t id5tify su* pati5ts at risk ( opioid use disord] pre-op]ation4 7,b7 ,%>$ decision mak+ ) pati5ts & families on pa9 managem5t1 includ+ recomm5dations = ! developm5t ( an evaluation & managem5t code = purposes ( paym5t "u ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act t w\ld acc\nt = "t sp5t on %>$ decision mak+4 7,c7 ,education on ! safe use1 /orage1 & disposal ( opioids4 7,d7 ,prev5tion ( opioid misuse & abuse aft] dis*>ge4 7,e7 ,developm5t ( a cl9ical algori?m to id5tify & treat at-risk1 opiate-tol]ant pati5ts & r$uce reliance on opioids = acute pa9 dur+ ! p]iop]ative p]iod4 7#b7 ,report ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y %all submit to ,congress & make public a report conta9+ ! recomm5dations develop$ "u p>agraph 7#a7 & an action plan = broad] implem5tation ( pa9 managem5t protocols t limit ! use ( opioids 9 ! p]iop]ative sett+ & ^u dis*>ge f su* sett+4 7b7 ,data collection on p]iop]ative opioid use ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ,congress a report t conta9s ! foll[+3 7#a7 ,! diagnosis-relat$ gr\p codes id5tifi$ by ! ,secret>y z hav+ ! highe/ volume ( surg]ies4 7#b7 ,) respect to ea* ( su* diagnosis-relat$ gr\p codes s id5tifi$1 a det]m9ation by ! ,secret>y ( ! data t is bo? available & report$ on opioid use foll[+ su* surg]ies1 su* z ) respect to-- 7,a7 surgical volumes1 practices1 & opioid prescrib+ patt]ns2 7,b7 opioid consumption1 includ+-- 7i7 p]iop]ative days ( !rapy2 7ii7 av]age daily dose at ! hospital1 includ+ dosage great] ?an #ij milligram morph9e equival5t2 7iii7 po/-dis*>ge prescriptions & o!r comb9ation drugs t are us$ be=e int]v5tion & aft] int]v5tion2 7iv7 quantity & duration ( opioid prescription at dis*>ge2 & 7v7 quantity consum$ & numb] ( refills2 7,c7 regional ane/hesia & analgesia practices1 includ+ pre-surgical & po/-surgical injections2 7,d7 naloxone rev]sal2 7,e7 po/-op]ative respiratory failure2 7,f7 in=mation ab\t /orage & disposal2 & 7,g7 su* o!r in=mation z ! ,secret>y may specify4 7#c7 ,recomm5dations = improv+ data collection on p]iop]ative opioid use1 includ+ an analysis to id5tify & r$uce b>ri]s to collect+1 report+1 & analyz+ ! data describ$ 9 p>agraph 7#b71 includ+ b>ri]s relat$ to te*nological availability4 #fjie4 ,requir+ ! po/+ & p]iodic update ( opioid prescrib+ guidance = ,m$ic>e b5efici>ies 7a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 %all po/ on ! public website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices all guidance publi%$ by ! ,dep>tm5t ( ,heal? & ,human ,s]vices on or aft] ,janu>y #a1 #bjaf1 relat+ to ! prescrib+ ( opioids & applicable to opioid prescriptions = individuals entitl$ to b5efits "u "p ,a ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;c et seq47 or enroll$ "u "p ,b ( su* title ( su* ,act 7#db ,u4,s4,c4 #acie;j et seq474 7b7 ,update ( guidance 7#a7 ,p]iodic update ,! ,secret>y %all1 9 consultation ) ! entities specifi$ 9 p>agraph 7#b71 p]iodically 7z det]m9$ appropriate by ! ,secret>y7 update guidance describ$ 9 subsection 7a7 & revise ! po/+ ( su* guidance on ! website describ$ 9 su* subsection4 7#b7 ,consultation ,! entities specifi$ 9 ?is p>agraph are ! foll[+3 7,a7 ,m$ical pr(essional organizations4 7,b7 ,provid]s & suppli]s ( s]vices 7z su* t]ms are def9$ 9 section #ahfa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex774 7,c7 ,heal? c>e consum]s or gr\ps repres5t+ su* consum]s4 7,d7 ,o!r entities det]m9$ appropriate by ! ,secret>y4 ,k ,/op ,excessive ,n>cotics 9 our ,retirem5t ,communities ,protection #faja4 ,%ort title ,?is subtitle may be cit$ z ! ,/op ,excessive ,n>cotics 9 our ,retirem5t ,communities ,protection ,act ( #bjah or ! ,,s5ior ,communities ,protection ,act ( #bjah4 #fajb4 ,susp5sion ( paym5ts by ,m$ic>e prescription drug plans & ,,ma-,,pd plans p5d+ inve/igations ( cr$ible allegations ( fraud by ph>macies 7a7 ,9 g5]al ,section #ahfj;,d-#ab7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#g7 ,susp5sion ( paym5ts p5d+ inve/igation ( cr$ible allegations ( fraud by ph>macies 7,a7 ,9 g5]al ,! provisions ( section #ahfb7o7 %all apply ) respect to a ,,pdp sponsor ) a contract "u ?is "p1 a ph>macy1 & paym5ts to su* ph>macy "u ?is "p 9 ! same mann] z su* provisions apply ) respect to ! ,secret>y1 a provid] ( s]vices or suppli]1 & paym5ts to su* provid] ( s]vices or suppli] "u ?is title4 7,b7 ,rule ( con/ruction ,no?+ 9 ?is p>agraph %all be con/ru$ z limit+ ! au?ority ( a ,,pdp sponsor to conduct po/paym5t review4 4 7b7 ,application to ,,ma-,,pd plans ,section #aheg7;f77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;f77#c77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,d7 ,susp5sion ( paym5ts p5d+ inve/igation ( cr$ible allegations ( fraud by ph>macies ,section #ahfj;,d-#ab7;b77#g74 4 7c7 ,con=m+ am5dm5t ,section #ahfb7o77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciey7o77#c77 is am5d$ by ins]t+ 1 section #ahfj;,d-#ab7;b77#g7 7includ+ z appli$ pursuant to section #aheg7;f77#c77;,d771 aft] ?is subsection4 7d7 ,cl>ification relat+ to cr$ible allegation ( fraud ,section #ahfb7o7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciey7o77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#d7 ,cr$ible allegation ( fraud ,9 c>ry+ out ?is subsection1 section #ahfj;,d-#ab7;b77#g7 7includ+ z appli$ pursuant to section #aheg7;f77#c77;,d771 & section #aijc7;i77#b77;,c71 a fraud hotl9e tip 7z def9$ by ! ,secret>y7 )\t fur!r evid5ce %all n be treat$ z suffici5t evid5ce = a cr$ible allegation ( fraud4 4 7e7 ,effective date ,! am5dm5ts made by ?is section %all apply ) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbj4 ,l ,provid+ ,reliable ,options = ,pati5ts & ,educational ,res\rces #faaa4 ,%ort title ,?is subtitle may be cit$ z ! ,provid+ ,reliable ,options = ,pati5ts & ,educational ,res\rces ,act ( #bjah or ! ,,prop] ,act ( #bjah4 #faab4 ,requir+ ,m$ic>e ,advantage plans & "p ,d prescription drug plans to include in=mation on risks associat$ ) opioids & cov]age ( nonph>macological !rapies & nonopioid m$ications or devices us$ to treat pa9 ,section #ahfj;,d-#d7;a77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;a77#a77 is am5d$-- 7#a7 9 subp>agraph 7,a71 by ins]t+ 1 subject to subp>agraph 7,c71 be=e includ+2 7#b7 9 subp>agraph 7,b71 by add+ at ! end ! foll[+ new clause3 7vi7 ,= plan ye> #bjba & ea* subsequ5t plan ye>1 subject to subp>agraph 7,c71 ) respect to ! treatm5t ( pa9-- 7,i7 ! risks associat$ ) prolong$ opioid use2 & 7,,ii7 cov]age ( nonph>macological !rapies1 devices1 & nonopioid m$ications-- 7aa7 9 ! case ( an ,,ma-,,pd plan "u "p ,c1 "u su* plan2 & 7bb7 9 ! case ( a prescription drug plan1 "u su* plan & "u p>ts ,a & ,b4 2 & 7#c7 by add+ at ! end ! foll[+ new subp>agraph3 7,c7 ,t>get$ provision ( in=mation ,a ,,pdp sponsor ( a prescription drug plan may1 9 lieu ( disclos+ ! in=mation describ$ 9 subp>agraph 7,b77vi7 to ea* enrollee "u ! plan1 disclose su* in=mation ?r\gh mail or electronic communications to a subset ( enrollees "u ! plan1 su* z enrollees :o h be5 prescrib$ an opioid 9 ! previ\s #b-ye> p]iod4 4 #faac4 ,requir+ ,m$ic>e ,advantage plans & prescription drug plans to provide in=mation on ! safe disposal ( prescription drugs 7a7 ,m$ic>e ,advantage ,section #aheb ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bb7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7n7 ,provision ( in=mation relat+ to ! safe disposal ( c]ta9 prescription drugs 7#a7 ,9 g5]al ,9 ! case ( an individual enroll$ "u an ,,ma or ,,ma-,,pd plan :o is furni%$ an 9-home heal? risk assessm5t on or aft] ,janu>y #a1 #bjba1 su* plan %all ensure t su* assessm5t includes in=mation on ! safe disposal ( prescription drugs t are controll$ sub/ances t meets ! crit]ia e/abli%$ "u p>agraph 7#b74 ,su* in=mation %all include in=mation on drug takeback programs t meet su* requirem5ts det]m9$ appropriate by ! ,secret>y & in=mation on 9-home disposal4 7#b7 ,crit]ia ,! ,secret>y %all1 ?r\gh rulemak+1 e/abli% crit]ia ! ,secret>y det]m9es appropriate ) respect to in=mation provid$ to an individual to ensure t su* in=mation suffici5tly educates su* individual on ! safe disposal ( prescription drugs t are controll$ sub/ances4 4 7b7 ,prescription drug plans ,section #ahfj;,d-#d7;c77#b77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c77#b77;,b77 is am5d$-- 7#a7 by /rik+ may include elem5ts t promote2 7#b7 by r$esignat+ clauses 7i7 ?r\gh 7iii7 z subclauses 7,i7 ?r\gh 7,,iii7 & adju/+ ! m>g9s accord+ly2 7#c7 by ins]t+ be=e subclause 7,i71 z s r$esignat$1 ! foll[+ new clause3 7i7 may include elem5ts t promote-- 2 7#d7 9 subclause 7,,iii71 z s r$esignat$1 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7#e7 by add+ at ! end ! foll[+ new clause3 7ii7 ) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjba1 %all provide =-- 7,i7 ! provision ( in=mation to ! enrollee on ! safe disposal ( prescription drugs t are controll$ sub/ances t meets ! crit]ia e/abli%$ "u section #aheb7n77#b71 includ+ in=mation on drug takeback programs t meet su* requirem5ts det]m9$ appropriate by ! ,secret>y & in=mation on 9-home disposal2 & 7,,ii7 co/-effective means by :i* an enrollee may s safely dispose ( su* drugs4 4 #faad4 ,revis+ measures us$ "u ! ,hospital ,consum] ,assessm5t ( ,heal?c>e ,provid]s & ,sy/ems survey relat+ to pa9 managem5t 7a7 ,re/riction on ! use ( pa9 que/ions 9 ,,hcahps ,section #ahhf7;b77#c77;,b77viii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7b77#c77;,b77viii77 is am5d$ by add+ at ! end ! foll[+ new subclause3 7,,xii7 7aa7 ,) respect to a ,hospital ,consum] ,assessm5t ( ,heal?c>e ,provid]s & ,sy/ems survey 7or a successor survey7 conduct$ on or aft] ,janu>y #a1 #bjai1 su* survey may n include que/ions ab\t communication by hospital /aff ) an individual ab\t su* individual's pa9 unless su* que/ions take into acc\nt1 z applicable1 :e!r an individual exp]i5c+ pa9 0 in=m$ ab\t risks associat$ ) ! use ( opioids & ab\t non-opioid alt]natives = ! treatm5t ( pa94 7bb7 ,! ,secret>y %all n include on ! ,hospital ,comp>e ,int]net website any measures bas$ on ! que/ions appe>+ on ! ,hospital ,consum] ,assessm5t ( ,heal?c>e ,provid]s & ,sy/ems survey 9 #bjah ab\t communication by hospital /aff ) an individual ab\t su* individual's pa94 4 7b7 ,re/riction on use ( #bjah pa9 que/ions 9 ! hospital value-bas$ pur*as+ program ,section #ahhf7o77#b77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7o77#b77;,b77 is am5d$ by add+ at ! end ! foll[+ new clause3 7iii7 ,,hcahps pa9 que/ions ,! ,secret>y may n include "u subp>agraph 7,a7 a measure t is bas$ on ! que/ions appe>+ on ! ,hospital ,consum] ,assessm5t ( ,heal?c>e ,provid]s & ,sy/ems survey 9 #bjah ab\t communication by hospital /aff ) an individual ab\t ! individual's pa94 4 ,,vii ,o!r ,heal? ,provisions ,a ,syn!tic ,drug ,aw>5ess #gjja4 ,%ort title ,?is subtitle may be cit$ z ! ,syn!tic ,drug ,aw>5ess ,act ( #bjah4 #gjjb4 ,report on effects on public heal? ( syn!tic drug use 7a7 ,9 g5]al ,n lat] ?an #c ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,surgeon ,g5]al ( ! ,public ,heal? ,s]vice %all submit to ,congress a report on ! heal? effects ( new psy*oactive sub/ances 7includ+ syn!tic drugs7 us$ s9ce ,janu>y #bjaj by p]sons :o are at lea/ #ab ye>s ( age b no m ?an #ah ye>s ( age4 7b7 ,new psy*oactive sub/ance def9$ ,= purposes ( subsection 7a71 ! t]m new psy*oactive sub/ance means a controll$ sub/ance analogue 7z def9$ 9 section #ajb7cb7 ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hjb7cb774 ,b ,emp[]+ ,ph>maci/s 9 ! ,fight ,aga9/ ,opioid ,abuse #gjaa4 ,%ort title ,?is subtitle may be cit$ z ! ,emp[]+ ,ph>maci/s 9 ! ,fight ,aga9/ ,opioid ,abuse ,act4 #gjab4 ,programs & mat]ials = tra9+ on c]ta9 circum/ances "u :i* a ph>maci/ may decl9e to fill a prescription 7a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 9 consultation ) ! ,adm9i/rator ( ! ,drug ,en=cem5t ,adm9i/ration1 ! ,commission] ( ,food & ,drugs1 ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 & ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use1 %all develop & dissem9ate programs & mat]ials = tra9+ ph>maci/s1 heal? c>e provid]s1 & pati5ts on-- 7#a7 circum/ances "u :i* a ph>maci/ may1 consi/5t ) section #bja ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #haa7 & regulations !reund]1 includ+ section #acjf4jd ( title #ba1 ,code ( ,f$]al ,regulations1 decl9e to fill a prescription = a controll$ sub/ance because ! ph>maci/ suspects ! prescription is fraudul5t1 =g$1 or o!rwise indicative ( abuse or div]sion2 & 7#b7 any ,f$]al requirem5ts p]ta9+ to decl9+ to fill a prescription "u su* circum/ances4 7b7 ,mat]ials includ$ ,9 develop+ mat]ials "u subsection 7a71 ! ,secret>y ( ,heal? & ,human ,s]vices %all include in=mation educat+-- 7#a7 ph>maci/s on h[ to decl9e to fill a prescription & actions to take aft] decl9+ to fill a prescription2 & 7#b7 o!r heal? c>e practition]s & ! public on a ph>maci/'s responsibility to decl9e to fill prescriptions 9 c]ta9 circum/ances4 7c7 ,/akehold] input ,9 develop+ ! programs & mat]ials requir$ "u subsection 7a71 ! ,secret>y ( ,heal? & ,human ,s]vices %all seek input f relevant national1 ,/ate1 & local associations1 bo>ds ( ph>macy1 m$ical societies1 lic5s+ bo>ds1 heal? c>e practition]s1 & pati5ts4 ,c ,index+ ,n>cotics1 ,f5tanyl1 & ,opioids #gjba4 ,%ort title ,?is subtitle may be cit$ z ! ,index+ ,n>cotics1 ,f5tanyl1 & ,opioids ,act ( #bjah or ! ,,info ,act4 #gjbb4 ,e/abli%m5t ( sub/ance use disord] in=mation da%bo>d ,title ,,xvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjju et seq47 is am5d$ by add+ at ! end ! foll[+ new section3 #agaa4 ,e/abli%m5t ( sub/ance use disord] in=mation da%bo>d 7a7 ,9 g5]al ,n lat] ?an #f mon?s aft] ! date ( ! enactm5t ( ?is section1 ! ,secret>y ( ,heal? & ,human ,s]vices %all1 9 consultation ) ! ,director ( ,national ,drug ,control ,policy1 e/abli% & p]iodically update a public in=mation da%bo>d t-- 7#a7 coord9ates in=mation on programs )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices relat$ to ! r$uction ( opioid abuse & o!r sub/ance use disord]s2 7#b7 provides access to publicly available data f o!r ,f$]al ag5cies2 ,/ate1 local1 & ,tribal gov]nm5ts2 nonpr(it organizations2 law en=cem5t2 m$ical exp]ts2 public heal? educators2 & rese>* in/itutions reg>d+ prev5tion1 treatm5t1 recov]y1 & o!r s]vices = opioid use disord] & o!r sub/ance use disord]s2 7#c7 provides comp>able data on sub/ance use disord] prev5tion & treatm5t /rategies 9 diff]5t regions & population ( ! ,unit$ ,/ates2 7#d7 provides recomm5dations = heal? c>e provid]s on alt]natives to controll$ sub/ances = pa9 managem5t1 includ+ approa*es /udi$ by ! ,national ,in/itutes ( ,heal? ,pa9 ,consortium & ! ,national ,c5t] = ,complim5t>y & ,integrative ,heal?2 & 7#e7 provides guidel9es & be/ practices = heal? c>e provid]s reg>d+ treatm5t ( sub/ance use disord]s4 7b7 ,controll$ sub/ance def9$ ,9 ?is section1 ! t]m controll$ sub/ance has ! mean+ giv5 t t]m 9 section #ajb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hjb74 4 #gjbc4 ,int]ag5cy ,sub/ance ,use ,disord] ,coord9at+ ,committee 7a7 ,e/abli%m5t ,n lat] ?an #c mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 %all1 9 consultation ) ! ,director ( ,national ,drug ,control ,policy1 e/abli% a committee1 to be kn[n z ! ,int]ag5cy ,sub/ance ,use ,disord] ,coord9at+ ,committee 79 ?is section ref]r$ to z ! ,committee 71 to coord9ate all ef=ts )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices conc]n+ sub/ance use disord]4 7b7 ,memb]%ip 7#a7 ,f$]al memb]s ,! foll[+ individuals %all be ! ,f$]al memb]s ( ! ,committee3 7,a7 ,! ,secret>y1 :o %all s]vice z ! ,*air ( ! ,committee4 7,b7 ,! ,attorney ,g5]al ( ! ,unit$ ,/ates4 7,c7 ,! ,secret>y ( ,labor4 7,d7 ,! ,secret>y ( ,h\s+ & ,urban ,developm5t4 7,e7 ,! ,secret>y ( ,education4 7,f7 ,! ,secret>y ( ,vet]ans ,affairs4 7,g7 ,! ,commission] ( ,social ,security4 7,h7 ,! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use4 7,i7 ,! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion4 7,j7 ,! ,director ( ! ,national ,in/itutes ( ,heal? & ! ,directors ( su* national rese>* in/itutes ( ! ,national ,in/itutes ( ,heal? z ! ,secret>y det]m9es appropriate4 7,k7 ,! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 7,l7 ,! ,director ( ,national ,drug ,control ,policy4 7,m7 ,repres5tatives ( o!r ,f$]al ag5cies t s]ve individuals ) sub/ance use disord]4 7#b7 ,non-,f$]al memb]s ,! ,committee %all include a m9imum ( #ag non-,f$]al memb]s appo9t$ by ! ,secret>y1 ( :i*-- 7,a7 at lea/ two su* memb]s %all be an individual :o has receiv$ treatm5t = a diagnosis ( an opioid use disord]2 7,b7 at lea/ two su* memb]s %all be an individual :o has receiv$ treatm5t = a diagnosis ( a sub/ance use disord] o!r ?an an opioid use disord]2 7,c7 at lea/ two su* memb]s %all be a ,/ate ,alcohol & ,sub/ance ,abuse ,director2 7,d7 at lea/ two su* memb]s %all be a repres5tative ( a lead+ rese>*1 advocacy1 or s]vice organization = adults ) sub/ance use disord]2 7,e7 at lea/ two su* memb]s %all-- 7i7 be a physician1 lic5s$ m5tal heal? pr(essional1 advance practice regi/]$ nurse1 or physician assi/ant2 & 7ii7 h exp]i5ce 9 treat+ individuals ) opioid use disord] or o!r sub/ance use disord]s2 7,f7 at lea/ "o su* memb] %all be a sub/ance use disord] treatm5t pr(essional :o is employ$ ) an opioid treatm5t program2 7,g7 at lea/ "o su* memb] %all be a sub/ance use disord] treatm5t pr(essional :o has rese>* or cl9ical exp]i5ce 9 work+ ) racial & e?nic m9ority populations2 7,h7 at lea/ "o su* memb] %all be a sub/ance use disord] treatm5t pr(essional :o has rese>* or cl9ical m5tal heal? exp]i5ce 9 work+ ) m$ically und]s]v$ populations2 7,i7 at lea/ "o su* memb] %all be a ,/ate-c]tifi$ sub/ance use disord] pe] support speciali/2 7,j7 at lea/ "o su* memb] %all be a drug c\rt judge or a judge ) exp]i5ce 9 adjudicat+ cases relat$ to sub/ance use disord]2 7,k7 at lea/ "o su* memb] %all be a law en=cem5t (fic] or correctional (fic] ) ext5sive exp]i5ce 9 int]act+ ) adults ) a sub/ance use disord]2 & 7,l7 at lea/ "o su* memb] %all be an individual ) exp]i5ce provid+ s]vices = homeless individuals & work+ ) adults ) a sub/ance use disord]4 7c7 ,t]ms 7#a7 ,9 g5]al ,a memb] ( ! ,committee appo9t$ "u subsection 7b77#b7 %all be appo9t$ = a t]m ( #c ye>s & may be reappo9t$ = "o or m #c-ye> t]ms4 7#b7 ,vacancies ,a vacancy on ! ,committee %all be fill$ 9 ! same mann] 9 :i* ! orig9al appo9tm5t 0 made4 ,any individual appo9t$ to fill a vacancy = an unexpir$ t]m %all be appo9t$ = ! rema9d] ( su* t]m & may s]ve aft] ! expiration ( su* t]m until a successor has be5 appo9t$4 7d7 ,meet+s ,! ,committee %all meet n few] ?an two times ea* ye>4 7e7 ,duties ,! ,committee %all-- 7#a7 monitor opioid use disord] & o!r sub/ance use disord] rese>*1 s]vices1 & support & prev5tion activities across all relevant ,f$]al ag5cies1 includ+ coord9ation ( ,f$]al activities ) respect to opioid use disord] & o!r sub/ance use disord]s2 7#b7 id5tify & provide to ! ,secret>y recomm5dations = improv+ ,f$]al grants & programs = ! prev5tion & treatm5t (1 & recov]y f1 opioid use disord] & o!r sub/ance use disord]s2 7#c7 review sub/ance use disord] prev5tion & treatm5t /rategies 9 diff]5t regions & populations 9 ! ,unit$ ,/ates & evaluate ! ext5t to :i* ,f$]al sub/ance use disord] prev5tion & treatm5t /rategies are align$ ) ,/ate & local sub/ance use disord] prev5tion & treatm5t /rategies2 7#d7 make recomm5dations to ! ,secret>y reg>d+ any appropriate *anges ) respect to ! activities & /rategies describ$ 9 p>agraphs 7#a7 ?r\gh 7#c72 7#e7 make recomm5dations to ! ,secret>y reg>d+ public p>ticipation 9 decisions relat+ to opioid use disord] & o!r sub/ance use disord]s & ! process by :i* public fe$back c be bett] integrat$ into su* decisions2 & 7#f7 make recomm5dations to ensure t opioid use disord] & o!r sub/ance use disord] rese>*1 s]vices1 & support & prev5tion activities ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices & o!r ,f$]al ag5cies are n unnecess>ily duplicative4 7f7 ,annual report 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 & annually !reaft] = ! life ( ! ,committee1 ! ,committee %all publi% on ! public in=mation da%bo>d e/abli%$ "u section #gjbb7;a7 a report summ>iz+ ! activities c>ri$ out by ! ,committee pursuant to subsection 7e71 includ+ any f9d+s result+ f su* activities4 7#b7 ,recomm5dation = ,committee ext5sion ,aft] ! publication ( ! second report ( ! ,committee "u p>agraph 7#a71 ! ,secret>y %all submit to ,congress a recomm5dation on :e!r or n ! op]ations ( ! ,committee %\ld cont9ue aft] ! t]m9ation date describ$ 9 subsection 7i74 7g7 ,work+ gr\ps ,! ,committee may e/abli% work+ gr\ps = purposes ( c>ry+ out ! duties describ$ 9 subsection 7e74 ,any su* work+ gr\p %all be compos$ ( memb]s ( ! ,committee 7or ! designees ( su* memb]s7 & may hold su* meet+s z are necess>y to enable ! work+ gr\p to c>ry out ! duties delegat$ to ! work+ gr\p4 7h7 ,f$]al ,advisory ,committee ,act ,! ,f$]al ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app47 %all apply to ! ,committee only to ! ext5t t ! provisions ( su* ,act d n conflict ) ! requirem5ts ( ?is section4 7i7 ,sunset ,! ,committee %all t]m9ate on ! date t is #f ye>s aft] ! date on :i* ! ,committee is e/abli%$ "u subsection 7a74 ,d ,ensur+ ,access to ,quality ,sob] ,liv+ #gjca4 ,%ort title ,?is subtitle may be cit$ z ! ,ensur+ ,access to ,quality ,sob] ,liv+ ,act ( #bjah4 #gjcb4 ,national recov]y h\s+ be/ practices ,"p ,p ( title ,,iii ( ! ,public ,heal? ,s]vice ,act is am5d$ by add+ at ! end ! foll[+ new section3 #cii,v-#g4 ,national recov]y h\s+ be/ practices 7a7 ,be/ practices ,! ,secret>y ( ,heal? & ,human ,s]vices1 9 consultation ) ! ,secret>y = ,h\s+ & ,urban ,developm5t1 pati5ts ) a hi/ory ( opioid use disord]1 & o!r /akehold]s1 :i* may include ,/ate accr$it+ entities & reputable provid]s1 analy/s1 & /akehold]s ( recov]y h\s+ s]vices1 su* z ! ,national ,alliance = ,recov]y ,resid5ces1 %all id5tify or facilitate ! developm5t ( be/ practices1 :i* may include model laws = implem5t+ sugge/$ m9imum /&>ds1 = op]at+ recov]y h\s+4 7b7 ,dissem9ation ,! ,secret>y %all dissem9ate ! be/ practices id5tifi$ or develop$ "u subsection 7a7 to-- 7#a7 ,/ate ag5cies1 :i* may include ! provision ( te*nical assi/ance to ,/ate ag5cies seek+ to adopt or implem5t su* be/ practices2 7#b7 recov]y h\s+ entities2 & 7#c7 ! public1 z appropriate4 7c7 ,def9itions ,9 ?is section3 7#a7 ,! t]m recov]y h\s+ means a %>$ liv+ environm5t free f alcohol & illicit drug use & c5t]$ on pe] support & connection to s]vices1 includ+ m$ication-assi/$ treatm5t s]vices1 t promote su/a9$ recov]y f sub/ance use disord]s4 7#b7 ,! t]m ,/ate includes any ( ! sev]al ,/ates1 ! ,di/rict ( ,columbia1 ea* ,indian tribe or tribal organization 7z ^? t]ms are def9$ 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act71 & any t]ritory or possession ( ! ,unit$ ,/ates4 7d7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re is au?oriz$ to be appropriat$ #c1jjj1jjj = ! p]iod ( fiscal ye>s #bjai ?r\gh #bjba4 4 ,e ,advanc+ ,cutt+ ,edge ,rese>* #gjda4 ,%ort title ,?is subtitle may be cit$ z ! ,advanc+ ,cutt+ ,edge ,rese>* ,act or ! ,,ace ,rese>* ,act4 #gjdb4 ,unique rese>* initiatives ,section #djb7n77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhb7n77#a77 is am5d$-- 7#a7 9 subp>agraph 7,a71 by /rik+ or2 7#b7 9 subp>agraph 7,b71 by /rik+ ! p]iod & ins]t+ 2 or2 & 7#c7 by add+ at ! end ! foll[+3 7,c7 high impact cutt+-edge rese>* t fo/]s sci5tific creativity & increases fundam5tal biological und]/&+ lead+ to ! prev5tion1 diagnosis1 or treatm5t ( diseases & disord]s1 or rese>* urg5tly requir$ to respond to a public heal? ?reat4 4 ,f ,jessie's ,law #gjea4 ,%ort title ,?is subtitle may be cit$ z ,jessie's ,law4 #gjeb4 ,inclusion ( opioid addiction hi/ory 9 pati5t records 7a7 ,be/ practices 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 9 consultation ) appropriate /akehold]s1 includ+ a pati5t ) a hi/ory ( opioid use disord]1 an exp]t 9 electronic heal? records1 an exp]t 9 ! confid5tiality ( pati5t heal? in=mation & records1 & a heal? c>e provid]1 %all id5tify or facilitate ! developm5t ( be/ practices reg>d+-- 7,a7 ! circum/ances "u :i* in=mation t a pati5t has provid$ to a heal? c>e provid] reg>d+ su* pati5t's hi/ory ( opioid use disord] %\ld1 only at ! pati5t's reque/1 be prom95tly display$ 9 ! m$ical records 7includ+ electronic heal? records7 ( su* pati5t2 7,b7 :at con/itutes ! pati5t's reque/ = ! purpose describ$ 9 subp>agraph 7,a72 & 7,c7 ! process & me?ods by :i* ! in=mation %\ld be s display$4 7#b7 ,dissem9ation ,! ,secret>y %all dissem9ate ! be/ practices develop$ "u p>agraph 7#a7 to heal? c>e provid]s & ,/ate ag5cies4 7b7 ,requirem5ts ,9 id5tify+ or facilitat+ ! developm5t ( be/ practices "u subsection 7a71 z applicable1 ! ,secret>y1 9 consultation ) appropriate /akehold]s1 %all consid] ! foll[+3 7#a7 ,! pot5tial = addiction relapse or ov]dose1 includ+ ov]dose dea?1 :5 opioid m$ications are prescrib$ to a pati5t recov]+ f opioid use disord]4 7#b7 ,! b5efits ( display+ in=mation ab\t a pati5t's opioid use disord] hi/ory 9 a mann] simil> to o!r pot5tially le?al m$ical conc]ns1 includ+ drug all]gies & contra9dications4 7#c7 ,! importance ( prom95tly display+ in=mation ab\t a pati5t's opioid use disord] :5 a physician or m$ical pr(essional is prescrib+ m$ication1 includ+ me?ods = avoid+ al]t fatigue 9 provid]s4 7#d7 ,! importance ( a v>iety ( appropriate m$ical pr(essionals1 includ+ physicians1 nurses1 & ph>maci/s1 to h access to in=mation describ$ 9 ?is section :5 prescrib+ or disp5s+ opioid m$ication1 consi/5t ) ,f$]al & ,/ate laws & regulations4 7#e7 ,! importance ( protect+ pati5t privacy1 includ+ ! requirem5ts relat$ to cons5t = disclosure ( sub/ance use disord] in=mation "u all applicable laws & regulations4 7#f7 ,all applicable ,f$]al & ,/ate laws & regulations4 #gjec4 ,communication ) families dur+ em]g5cies 7a7 ,promot+ aw>5ess ( au?oriz$ disclosures dur+ em]g5cies ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices & ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration1 %all annually develop & dissem9ate writt5 mat]ials 7electronically or by o!r means7 to heal? c>e provid]s reg>d+ p]mitt$ disclosures "u ,f$]al heal? c>e privacy law dur+ em]g5cies1 includ+ ov]doses1 ( c]ta9 heal? in=mation to families1 c>egiv]s1 & heal? c>e provid]s4 7b7 ,use ( mat]ial ,= ! purposes ( c>ry+ out subsection 7a71 ! ,secret>y ( ,heal? & ,human ,s]vices may use mat]ial produc$ "u section #aajjd ( ! #ba/ ,c5tury ,cures ,act 7#db ,u4,s4,c4 #acbj;d-#b note74 ,g ,safe ,disposal ( ,unus$ ,m$ication #gjfa4 ,%ort title ,?is subtitle may be cit$ z ! ,safe ,disposal ( ,unus$ ,m$ication ,act4 #gjfb4 ,disposal ( controll$ sub/ances ( a deceas$ hospice pati5t by employees ( a qualifi$ hospice program ,subsection 7g7 ( section #cjb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbb7 is am5d$ by add+ at ! end ! foll[+3 7#e7 7,a7 ,9 ! case ( a p]son receiv+ hospice c>e1 an employee ( a qualifi$ hospice program1 act+ )9 ! scope ( employm5t1 may h&le1 )\t be+ regi/]$ "u ?is section1 any controll$ sub/ance t 0 lawfully disp5s$ to ! p]son receiv+ hospice c>e1 = ! purpose ( disposal ( ! controll$ sub/ance aft] ! dea? ( su* p]son1 s long z su* disposal occurs onsite 9 accordance ) all applicable ,f$]al1 ,/ate1 ,tribal1 & local law4 7,b7 ,= ! purposes ( ?is p>agraph3 7i7 ,! t]ms hospice c>e & hospice program h ! mean+s giv5 to ^? t]ms 9 section #ahfa7;dd7 ( ! ,social ,security ,act4 7ii7 ,! t]m employee ( a qualifi$ hospice program means a physician1 nurse1 or o!r p]son :o-- 7,i7 is employ$ by1 or pursuant to arrangem5ts made by1 a qualifi$ hospice program2 7,,ii7 7aa7 is lic5s$ to p]=m m$ical or nurs+ s]vices by ! jurisdiction 9 :i* ! p]son receiv+ hospice c>e 0 locat$2 & 7bb7 is act+ )9 ! scope ( su* employm5t 9 accordance ) applicable ,/ate law2 & 7,,iii7 has complet$ tra9+ ?r\gh ! qualifi$ hospice program reg>d+ ! disposal ( controll$ sub/ances 9 a secure & responsible mann] s z to disc\rage abuse1 misuse1 or div]sion4 7iii7 ,! t]m qualifi$ hospice program means a hospice program t-- 7,i7 has writt5 policies & proc$ures = assi/+ 9 ! disposal ( ! controll$ sub/ances ( a p]son receiv+ hospice c>e aft] ! p]son's dea?2 7,,ii7 at ! "t :5 ! controll$ sub/ances are fir/ ord]$-- 7aa7 provides a copy ( ! writt5 policies & proc$ures to ! pati5t or pati5t repres5tative & family2 7bb7 discusses ! policies & proc$ures ) ! pati5t or repres5tative & ! family 9 a language & mann] t !y und]/& to ensure t ^! p>ties are educat$ reg>d+ ! safe disposal ( controll$ sub/ances2 & 7cc7 docum5ts 9 ! pati5t's cl9ical record t ! writt5 policies & proc$ures 7 provid$ & discuss$2 & 7,,iii7 at ! "t foll[+ ! disposal ( ! controll$ sub/ances-- 7aa7 docum5ts 9 ! pati5t's cl9ical record ! type ( controll$ sub/ance1 dosage1 r\te ( adm9i/ration1 & quantity s dispos$2 & 7bb7 ! "t1 date1 & mann] 9 :i* t disposal occurr$4 4 ,h ,sub/ance ,use ,disord] ,work=ce ,loan ,repaym5t #gjga4 ,%ort title ,?is subtitle may be cit$ z ! ,sub/ance ,use ,disord] ,work=ce ,loan ,repaym5t ,act ( #bjah4 #gjgb4 ,loan repaym5t program = sub/ance use disord] treatm5t employees ,title ,,vii ( ! ,public ,heal? ,s]vice ,act is am5d$-- 7#a7 by r$esignat+ "p ,f z "p ,g2 & 7#b7 by ins]t+ aft] "p ,e 7#db ,u4,s4,c4 #bidn et seq47 ! foll[+3 ,f ,sub/ance use disord] treatm5t employees #gha4 ,loan repaym5t program = sub/ance use disord] treatm5t employees 7a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration1 %all c>ry out a program "u :i*-- 7#a7 ! ,secret>y ent]s into agreem5ts ) individuals to make paym5ts 9 accordance ) subsection 7b7 on ! pr9cipal ( & int]e/ on any eligible loan2 & 7#b7 ! individuals ea* agree to complete a p]iod ( s]vice 9 a sub/ance use disord] treatm5t job1 z describ$ 9 subsection 7d74 7b7 ,paym5ts ,= ea* ye> ( obligat$ s]vice by an individual pursuant to an agreem5t "u subsection 7a71 ! ,secret>y %all make a paym5t to su* individual z foll[s3 7#a7 ,s]vice 9 a %ortage area ,! ,secret>y %all pay-- 7,a7 = ea* ye> ( obligat$ s]vice by an individual pursuant to an agreem5t "u subsection 7a71 #a_/f ( ! pr9cipal ( & int]e/ on ea* eligible loan ( ! individual :i* is out/&+ on ! date ! individual began s]vice pursuant to ! agreem5t2 & 7,b7 = completion ( ! six? & f9al ye> ( su* s]vice1 ! rema9d] ( su* pr9cipal & int]e/4 7#b7 ,maximum am\nt ,! total am\nt ( paym5ts "u ?is section to any individual %all n exce$ #bej1jjj4 7c7 ,eligible loans ,! loans eligible = repaym5t "u ?is section are ea* ( ! foll[+3 7#a7 ,any loan = education or tra9+ = a sub/ance use disord] treatm5t job4 7#b7 ,any loan "u "p ,e ( title ,,viii 7relat+ to nurs+ /ud5t loans74 7#c7 ,any ,f$]al ,direct ,/af=d ,loan1 ,f$]al ,direct ,,plus ,loan1 or ,f$]al ,direct ,unsubsidiz$ ,/af=d ,loan1 or ,f$]al ,direct ,consolidation ,loan 7z su* t]ms are us$ 9 section #dee ( ! ,high] ,education ,act ( #aife74 7#d7 ,any ,f$]al ,p]k9s ,loan "u "p ,e ( title ,i ( ! ,high] ,education ,act ( #aife4 7#e7 ,any o!r ,f$]al loan z det]m9$ appropriate by ! ,secret>y4 7d7 ,p]iod ( s]vice ,! p]iod ( s]vice requir$ by an agreem5t "u subsection 7a7 %all consi/ ( up to #f ye>s ( full-"t employm5t1 ) no m ?an #a ye> pass+ betwe5 any #b ye>s ( cov]$ employm5t1 9 a sub/ance use disord] treatm5t job 9 ! ,unit$ ,/ates 9-- 7#a7 a ,m5tal ,heal? ,pr(essional ,%ortage ,area1 z designat$ "u section #ccb2 or 7#b7 a c\nty 7or a municipality1 if n conta9$ )9 any c\nty7 :]e ! mean drug ov]dose dea? rate p] #ajj1jjj p ov] ! pa/ #c ye>s = :i* (ficial data is available f ! ,/ate1 is high] ?an ! mo/ rec5t available national av]age ov]dose dea? rate p] #ajj1jjj p1 z report$ by ! ,c5t]s = ,disease ,control & ,prev5tion4 7e7 ,ineligibility = d\ble b5efits ,no borr[] may1 = ! same s]vice1 receive a r$uction ( loan obligations or a loan repaym5t "u bo?-- 7#a7 ?is subsection2 & 7#b7 any ,f$]ally support$ loan =giv5ess program1 includ+ "u section #cch;,b1 #cch;,i1 or #hdf ( ?is ,act1 or section #dbh;,j1 #dbh,l1 #dee7m71 or #dfj ( ! ,high] ,education ,act ( #aife4 7f7 ,brea* 7#a7 ,liquidat$ damages =mula ,! ,secret>y may e/abli% a liquidat$ damages =mula to be us$ 9 ! ev5t ( a brea* ( an agreem5t ent]$ into "u subsection 7a74 7#b7 ,limitation ,! failure by an individual to complete ! full p]iod ( s]vice obligat$ pursuant to su* an agreem5t1 tak5 alone1 %all n con/itute a brea* ( ! agreem5t1 s long z ! individual complet$ 9 good fai? ! ye>s ( s]vice = :i* paym5ts 7 made to ! individual "u ?is section4 7g7 ,additional crit]ia ,! ,secret>y-- 7#a7 may e/abli% su* crit]ia & rules to c>ry out ?is section z ! ,secret>y det]m9es are ne$$ & 9 addition to ! crit]ia & rules specifi$ 9 ?is section2 & 7#b7 %all give notice to ! committees specifi$ 9 subsection 7h7 ( any crit]ia & rules s e/abli%$4 7h7 ,report to ,congress ,n lat] ?an #e ye>s aft] ! date ( enactm5t ( ! ,sub/ance ,use ,disord] ,work=ce ,loan ,repaym5t ,act ( #bjah1 & e o!r ye> !reaft]1 ! ,secret>y %all prep>e & submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report on-- 7#a7 ! numb] & location ( borr[]s :o h qualifi$ = loan repaym5ts "u ?is section2 & 7#b7 ! impact ( ?is section on ! availability ( sub/ance use disord] treatm5t employees nationally & 9 %ortage areas & c\nties describ$ 9 subsection 7d74 7i7 ,def9ition ,9 ?is section3 7#a7 ,! t]m municipality means a city1 t[n1 or o!r public body creat$ by or pursuant to ,/ate law1 or an ,indian ,tribe4 7#b7 ,! t]m sub/ance use disord] treatm5t job means a full-"t job 7includ+ a fell[%ip7-- 7,a7 :]e ! prim>y int5t & function ( ! job is ! direct treatm5t or recov]y support ( pati5ts ) or 9 recov]y f a sub/ance use disord]1 su* z a physician1 physician assi/ant1 regi/]$ nurse1 nurse practition]1 advanc$ practice regi/]$ nurse1 social work]1 recov]y coa*1 m5tal heal? c\nselor1 addictions c\nselor1 psy*ologi/ or o!r behavioral heal? pr(essional1 or any o!r relevant pr(essional z det]m9e by ! ,secret>y2 & 7,b7 :i* is locat$ at a sub/ance use disord] treatm5t program1 private physician practice1 hospital or heal? sy/em-affiliat$ inpati5t treatm5t c5t] or outpati5t cl9ic 7includ+ an academic m$ical c5t]-affiliat$ treatm5t program71 correctional facility or program1 y\? det5tion c5t] or program1 inpati5t psy*iatric facility1 crisis /abilization unit1 community heal? c5t]1 community m5tal heal? or o!r specialty community behavioral heal? c5t]1 recov]y c5t]1 s*ool1 community-bas$ organization1 teleheal? plat=m1 migrant heal? c5t]1 heal? program or facility op]at$ by a tribe or tribal organization1 ,f$]al m$ical facility1 or any o!r facility z det]m9$ appropriate = purposes ( ?is section by ! ,secret>y4 7j7 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ to c>ry out ?is section #be1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbh4 4 ,i ,prev5t+ ,ov]doses ,:ile 9 ,em]g5cy ,rooms #gjha4 ,%ort title ,?is subtitle may be cit$ z ! ,prev5t+ ,ov]doses ,:ile 9 ,em]g5cy ,rooms ,act ( #bjah4 #gjhb4 ,program to support em]g5cy room dis*>ge & c>e coord9ation = drug ov]dose pati5ts 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices %all e/abli% a program 79 ?is subtitle ref]r$ to z ! ,program7 to develop protocols = dis*>g+ pati5ts :o h pres5t$ ) a drug ov]dose & enhance ! integration & coord9ation ( c>e & treatm5t options = individuals ) sub/ance use disord] aft] dis*>ge4 7b7 ,grant e/abli%m5t & p>ticipation 7#a7 ,9 g5]al ,9 c>ry+ out ! ,program1 ! ,secret>y %all aw>d grants on a competitive basis to n m ?an #bj eligible entities describ$ 9 p>agraph 7#b74 7#b7 ,eligibility 7,a7 ,9 g5]al ,to be eligible = a grant "u ?is subsection1 an entity %all be-- 7i7 a heal? c>e site describ$ 9 subp>agraph 7,b72 or 7ii7 a heal? c>e site coord9ator describ$ 9 subp>agraph 7,c74 7,b7 ,heal? c>e sites ,to be eligible = a grant "u ?is section1 a heal? c>e site %all-- 7i7 submit an application to ! ,secret>y at su* "t1 9 su* mann]1 & conta9+ su* in=mation z specifi$ by ! ,secret>y2 7ii7 h an em]g5cy dep>tm5t2 7iii7 7,i7 h a lic5s$ heal? c>e pr(essional onsite :o has a waiv] "u section #cjc7;g7 ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbc7;g77 to disp5se or prescribe cov]$ drugs2 or 7,,ii7 h a demon/rable plan to hire a suffici5t numb] ( full-"t lic5s$ heal? c>e pr(essionals :o h waiv]s describ$ 9 subclause 7,i7 to adm9i/] su* treatm5t onsite2 7iv7 h 9 place an agreem5t ) a suffici5t numb] & range ( entities c]tifi$ "u applicable ,/ate & ,f$]al law1 su* z pursuant to regi/ration or a waiv] "u section #cjc7;g7 ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbc7;g77 or c]tification z describ$ 9 section #h4b ( title #db ( ! ,code ( ,f$]al ,regulations1 to provide treatm5t = sub/ance use disord] su* t ! entity or ! result+ network ( entities ) an agreem5t ) ! hospital cumulatively are capable ( provid+ all evid5ce-bas$ s]vices = ! treatm5t ( sub/ance use disord]1 z m$ically appropriate = ! individual involv$1 includ+-- 7,i7 m$ication-assi/$ treatm5t2 7,,ii7 )drawal & detoxification s]vices t include pati5t evaluation1 /abilization1 & read9ess = & entry into treatm5t2 & 7,,iii7 c\nsel+2 7v7 deploy onsite pe] recov]y speciali/s to help connect pati5ts ) treatm5t & recov]y support s]vices2 & 7vi7 include ! provision ( ov]dose rev]sal m$ication 9 dis*>ge protocols = opioid ov]dose pati5ts4 7,c7 ,heal? c>e site coord9ators ,to be eligible = a grant "u ?is section1 a heal? c>e site coord9ator %all-- 7i7 be an organization describ$ 9 section #eja7;c77#c7 ( ! ,int]nal ,rev5ue ,code ( #aihf 7& exempt f tax "u section #eja7;a7 ( su* ,code7 or a ,/ate1 local1 or ,tribal gov]nm5t2 7ii7 submit an application to ! ,secret>y at su* "t1 9 su* mann]1 & conta9+ su* in=mation z specifi$ by ! ,secret>y2 & 7iii7 h an agreem5t ) multiple eligible heal? c>e sites describ$ 9 subp>agraph 7,b74 7#c7 ,pref]5ce ,9 aw>d+ grants "u ?is section1 ! ,secret>y may give pref]5ce to eligible entities describ$ 9 p>agraph 7#b7 t meet ei!r or bo? ( ! foll[+ crit]ia3 7,a7 ,! eligible heal? c>e site is1 or ! eligible heal? c>e site coord9ator has an agreem5t describ$ 9 p>agraph 7#b77;,c77iii7 ) a site t is1 a critical access hospital 7z def9$ 9 section #ahfa7mm77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7mm77#a7771 a l[-volume hospital 7z def9$ 9 section #ahhf7;d77#ab77;,c77i7 ( su* ,act 7#db ,u4,s4,c4 #acieww7d77#ab77;,c77i7771 or a sole community hospital 7z def9$ 9 section #ahhf7;d77#e77;,d77iii7 ( su* ,act 7#db ,u4,s4,c4 #acieww7d77#e77;,d77iii7774 7,b7 ,! eligible heal? c>e site or ! eligible heal? c>e site coord9ator is locat$ 9 a geographic area ) a drug ov]dose rate t is high] ?an ! national rate1 or 9 a geographic area ) a rate ( em]g5cy dep>tm5t visits = ov]doses t is high] ?an ! national rate1 z det]m9$ by ! ,secret>y bas$ on ! mo/ rec5t data f ! ,c5t]s = ,disease ,control & ,prev5tion4 7#d7 ,m$ication-assi/$ treatm5t def9$ ,= purposes ( ?is section1 ! t]m m$ication-assi/$ treatm5t means ! use ( a drug approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or a biological product lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb71 9 comb9ation ) behavioral heal? s]vices1 to provide an individualiz$ approa* to ! treatm5t ( sub/ance use disord]s1 includ+ opioid use disord]s4 7c7 ,p]iod ( grant ,a grant aw>d$ to an eligible entity "u ?is section %all be = a p]iod ( at lea/ #b ye>s4 7d7 ,grant uses 7#a7 ,requir$ uses ,a grant aw>d$ "u ?is section to an eligible entity %all be us$ = bo? ( ! foll[+ purposes3 7,a7 ,to e/abli% policies & proc$ures t address ! provision ( ov]dose rev]sal m$ication1 prescription & disp5s+ ( m$ication-assi/$ treatm5t to an em]g5cy dep>tm5t pati5t :o has _h a non-fatal ov]dose or :o is at risk ( a drug ov]dose1 & ! subsequ5t ref]ral to evid5ce-bas$ treatm5t ^u dis*>ge = pati5ts :o h exp]i5c$ a non-fatal drug ov]dose or :o are at risk ( a drug ov]dose4 7,b7 ,to develop be/ practices = treat+ non-fatal drug ov]doses1 includ+ ) respect to c>e coord9ation & integrat$ c>e models = long t]m treatm5t & recov]y options = individuals :o h exp]i5c$ a non-fatal drug ov]dose4 7#b7 ,additional p]missible uses ,a grant aw>d$ "u ?is section to an eligible entity may be us$ = any ( ! foll[+ purposes3 7,a7 ,to hire em]g5cy dep>tm5t pe] recov]y speciali/s2 c\nselors2 !rapi/s2 social work]s2 or o!r lic5s$ m$ical pr(essionals specializ+ 9 ! treatm5t ( sub/ance use disord]4 7,b7 ,to e/abli% integrat$ models ( c>e = individuals :o h exp]i5c$ a non-fatal drug ov]dose :i* may include pati5t assessm5t1 foll[ up1 & transportation to treatm5t facilities4 7,c7 ,to provide = options = increas+ ! availability & access ( m$ication-assi/$ treatm5t & o!r evid5ce-bas$ treatm5t = individuals ) sub/ance use disord]s4 7,d7 ,to (f] consultation ) & ref]ral to o!r supportive s]vices t help 9 treatm5t & recov]y4 7e7 ,report+ requirem5ts 7#a7 ,reports by grantees ,ea* eligible entity aw>d$ a grant "u ?is section %all submit to ! ,secret>y an annual report = ea* ye> = :i* ! entity has receiv$ su* grant t includes in=mation on-- 7,a7 ! numb] ( individuals treat$ at ! site 7or1 9 ! case ( an eligible heal? c>e site coord9ator1 at sites cov]$ by ! agreem5t ref]r$ to 9 subsection 7b77#b77;,c77iii77 = non-fatal ov]doses 9 ! em]g5cy dep>tm5t2 7,b7 ! numb] ( individuals adm9i/]$ ea* m$ication-assi/$ treatm5t at su* site or sites 9 ! em]g5cy dep>tm5t2 7,c7 ! numb] ( individuals ref]r$ by su* site or sites to o!r treatm5t facilities aft] a non-fatal ov]dose1 ! types ( su* o!r facilities1 & ! numb] ( su* individuals admitt$ to su* o!r facilities pursuant to su* ref]rals2 7,d7 ! frequ5cy & numb] ( pati5t readmissions = non-fatal ov]doses & sub/ance use disord]2 7,e7 = :at ! grant fund+ 0 us$2 & 7,f7 ! effectiv5ess (1 & any o!r relevant additional data reg>d+1 hav+ an onsite heal? c>e pr(essional to adm9i/] & beg9 m$ication-assi/$ treatm5t = sub/ance use disord]s4 7#b7 ,report by ,secret>y ,n less ?an #a ye> aft] ! conclusion ( ! ,program1 ! ,secret>y %all submit to ,congress a report t includes-- 7,a7 f9d+s ( ! ,program2 7,b7 ov]all pati5t outcomes "u ! ,program1 su* z ) respect to hospital readmission2 7,c7 :at p]c5tage ( pati5ts treat$ by a site fund$ ?r\gh a grant "u ?is section 7 readmitt$ to a hospital = non-fatal or fatal ov]dose2 7,d7 an evaluation det]m9+ ! effectiv5ess ( hav+ a practition] onsite to adm9i/] & beg9 m$ication-assi/$ treatm5t = sub/ance use disord]2 & 7,e7 a compilation ( volunt>y guidel9es & be/ practices f ! reports submitt$ "u p>agraph 7#a74 7f7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ to c>ry out ?is subtitle #ej1jjj1jjj = ! p]iod ( fiscal ye>s #bjai ?r\gh #bjbc4 ,j ,alt]natives to ,opioids 9 ! ,em]g5cy ,dep>tm5t #gjia4 ,%ort title ,?is subtitle may be cit$ z ! ,alt]natives to ,opioids 9 ! ,em]g5cy ,dep>tm5t ,act or ! ,,alto ,act4 #gjib4 ,em]g5cy dep>tm5t alt]natives to opioids demon/ration program 7a7 ,demon/ration program grants ,! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is section ref]r$ to z ! ,secret>y7 %all c>ry out a demon/ration program "u :i* ! ,secret>y %all aw>d grants to hospitals & em]g5cy dep>tm5ts1 includ+ free/&+ em]g5cy dep>tm5ts1 to develop1 implem5t1 enhance1 or /udy alt]native pa9 managem5t protocols & treatm5ts t limit ! use & prescription ( opioids 9 em]g5cy dep>tm5ts4 7b7 ,eligibility ,to be eligible to receive a grant "u subsection 7a71 a hospital or em]g5cy dep>tm5t %all submit an application to ! ,secret>y at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y may require4 7c7 ,geographic div]sity ,9 aw>d+ grants "u ?is section1 ! ,secret>y %all seek to ensure geographical div]sity among grant recipi5ts4 7d7 ,use ( funds ,grants "u subsection 7a7 %all be us$ to-- 7#a7 t>get common pa9ful conditions1 su* z r5al colic1 sciatica1 heada*es1 musculoskeletal pa91 & extremity fractures2 7#b7 tra9 provid]s & o!r hospital p]sonnel on protocols & ! use ( treatm5ts t limit ! use & prescription ( opioids 9 ! em]g5cy dep>tm5t2 & 7#c7 provide alt]natives to opioids to pati5ts ) pa9ful conditions1 n includ+ pati5ts :o pres5t ) pa9 relat$ to canc]1 end-(-life symptom palliation1 or complex multisy/em trauma4 7e7 ,consultation ,! ,secret>y %all implem5t a process = recipi5ts ( grants "u subsection 7a7 to consult 79 a mann] t all[s = %>+ ( evid5ce-bas$ be/ practices7 ) ea* o!r & ) p]sons hav+ robu/ k1 includ+ em]g5cy dep>tm5ts & physicians t h successfully deploy$ alt]native pa9 managem5t protocols1 su* z non-drug approa*es /udi$ ?r\gh ! ,national ,c5t] = ,complim5t>y & ,integrative ,heal? includ+ acupuncture t limit ! use ( opioids4 ,! ,secret>y %all (f] to ea* recipi5t ( a grant "u subsection 7a7 te*nical support z necess>y4 7f7 ,report to ! ,secret>y ,ea* recipi5t ( a grant "u ?is section %all submit to ! ,secret>y 7dur+ ! p]iod ( su* grant7 annual reports on ! progress ( ! program fund$ ?r\gh ! grant4 ,^! reports %all include1 9 accordance ) ,/ate & ,f$]al /atutes & regulations reg>d+ disclosure ( pati5t in=mation-- 7#a7 a description ( & specific in=mation ab\t ! alt]native pa9 managem5t protocols employ$2 7#b7 data on ! alt]native pa9 managem5t protocols & treatm5ts employ$1 includ+-- 7,a7 dur+ a basel9e p]iod be=e ! program began1 z def9$ by ! ,secret>y2 7,b7 at v>i\s /ages ( ! program1 z det]m9$ by ! ,secret>y2 & 7,c7 ! conditions = :i* ! alt]native pa9 managem5t protocols & treatm5ts 7 employ$2 7#c7 ! success ( ea* specific alt]native pa9 managem5t protocol2 7#d7 data on ! opioid prescriptions writt51 includ+-- 7,a7 dur+ a basel9e p]iod be=e ! program began1 z def9$ by ! ,secret>y2 7,b7 at v>i\s /ages ( ! program1 z det]m9$ by ! ,secret>y2 & 7,c7 ! conditions = :i* ! opioids 7 prescrib$2 7#e7 ! demographic *>act]i/ics ( pati5ts :o 7 treat$ ) an alt]native pa9 managem5t protocol1 includ+ age1 sex1 race1 e?nicity1 & insurance /atus & type2 7#f7 data on pati5ts :o 7 ev5tually prescrib$ opioids aft] alt]native pa9 managem5t protocols & treatm5ts 7 employ$2 & 7#g7 any o!r in=mation ! ,secret>y deems necess>y4 7g7 ,report to ,congress ,n lat] ?an #a ye> aft] completion ( ! demon/ration program "u ?is section1 ! ,secret>y %all submit a report to ! ,congress on ! results ( ! demon/ration program & include 9 ! report-- 7#a7 ! numb] ( applications receiv$ & ! numb] fund$2 7#b7 a summ>y ( ! reports describ$ 9 subsection 7f71 includ+ /&>diz$ data2 & 7#c7 recomm5dations = broad] implem5tation ( pa9 managem5t protocols t limit ! use & prescription ( opioids 9 em]g5cy dep>tm5ts or o!r areas ( ! heal? c>e deliv]y sy/em4 7h7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re is au?oriz$ to be appropriat$ #aj1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjba4 ,k ,/op ,c\nt]feit ,drugs by ,regulat+ & ,enhanc+ ,en=cem5t ,n[ #gaja4 ,%ort title ,?is subtitle may be cit$ z ! ,/op ,c\nt]feit ,drugs by ,regulat+ & ,enhanc+ ,en=cem5t ,n[ ,act or ! ,,scre5 ,act4 #gajb4 ,det5tion1 refusal1 & de/ruction ( drugs (f]$ = importation 7a7 ,increas+ ! maximum doll> am\nt ( drugs subject to de/ruction ,! six? s5t5ce 9 section #hja7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a77 is am5d$ by /rik+ except t ! ,secret>y & all t foll[s ?r\gh ! two p]iods at ! end & ins]t+ except t ! ,secret>y ( ,heal? & ,human ,s]vices may de/roy1 )\t ! opportunity = export1 any drug refus$ admission "u ?is section1 if su* drug is decl>$ to be valu$ at an am\nt t is #b1ejj or less 7or su* high] am\nt z ! ,secret>y ( ! ,treasury may set by regulation pursuant to section #dih7;a77#a7 ( ! ,t>iff ,act ( #aicj or su* high] am\nt z ! ,commission] ( ,food & ,drugs may set bas$ on a f9d+ by ! ,commission] t ! high] am\nt is 9 ! int]e/ ( public heal?71 or if su* drug is ent]+ ! ,unit$ ,/ates by mail1 & 0 n br\ght into compliance z describ$ "u subsection 7b744 7b7 ,de/ruction ( articles ( conc]n ,! six? s5t5ce ( section #hja7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a771 z am5d$ by subsection 7a71 is fur!r am5d$ by ins]t+ be=e ! p]iod at ! end ! foll[+3 2 & ! ,secret>y ( ,heal? & ,human ,s]vices may de/roy1 )\t ! opportunity = export1 any article refus$ admission "u clause 7#f7 ( ! ?ird s5t5ce ( ?is subsection4 7c7 ,te*nical am5dm5ts ,! sev5?1 eigh?1 & n9? s5t5ces ( section #hja7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a77 are am5d$-- 7#a7 by /rik+ a drug ea* place x appe>s & ins]t+ an article2 & 7#b7 by /rik+ ! drug ea* place x appe>s & ins]t+ ! article4 7d7 ,rule ( con/ruction ,! la/ s5t5ce 9 section #hja7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a77 is am5d$ to read z foll[s3 ,clauses 7#b71 7#e71 & 7#f7 ( ! ?ird s5t5ce ( ?is subsection %all n be con/ru$ to prohibit ! admission ( n>cotic or nonn>cotic drugs or o!r sub/ances1 ! importation ( :i* is p]mitt$ "u ! ,controll$ ,sub/ances ,import & ,export ,act44 #gajc4 ,notification1 nondi/ribution1 & recall ( adult]at$ or misbr&$ drug products 7a7 ,prohibit$ ,acts ,section #cja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is am5d$ by add+ at ! end ! foll[+3 7eee7 ,! failure to comply ) any ord] issu$ "u section #efi;,d4 4 7b7 ,notification1 nondi/ribution1 & recall ( adult]at$ or misbr&$ drugs ,sub*apt] ,e ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb et seq47 is am5d$ by add+ at ! end ! foll[+3 #efi;,d4 ,notification1 ,nondi/ribution1 ,& ,recall ,( ,adult]at$ ,or ,misbr&$ ,drugs 7a7 ,ord] ,to cease di/ribution & recall 7#a7 ,9 g5]al ,^u a det]m9ation t ! use or consumption (1 or exposure to1 a drug may pres5t an imm95t or sub/antial haz>d to ! public heal?1 ! ,secret>y %all issue an ord] requir+ any p]son :o di/ributes ! drug to imm$iately cease di/ribution ( ! drug4 7#b7 ,he>+ ,an ord] "u p>agraph 7#a7 %all provide ! p]son subject to ! ord] ) an opportunity = an in=mal he>+1 to be held n lat] ?an #aj days aft] ! date ( issuance ( ! ord]1 on-- 7,a7 ! actions requir$ by ! ord]2 & 7,b7 :e!r ! ord] %\ld be am5d$ to require a recall ( ! drug4 7#c7 ,inadequate gr\nds ,if1 aft] provid+ an opportunity = a he>+ "u p>agraph 7#b71 ! ,secret>y det]m9es t inadequate gr\nds exi/ to support ! actions requir$ by ! ord]1 ! ,secret>y %all vacate ! ord]4 7#d7 ,am5dm5t to ord] to require recall ,if1 aft] provid+ an opportunity = an in=mal he>+ "u p>agraph 7#b71 ! ,secret>y det]m9es t ! ord] %\ld be am5d$ to include a recall ( ! drug ) respect to :i* ! ord] 0 issu$1 ! ,secret>y %all-- 7,a7 am5d ! ord] to require a recall2 & 7,b7 aft] consultation ) ! drug sponsor1 specify a timetable 9 :i* ! recall w occur4 7#e7 ,notice to p]sons affect$ ,an ord] "u ?is subsection %all require any p]son :o di/ributes ! drug to provide = notice1 includ+ to individuals z appropriate1 to p]sons :o may be affect$ by ! ord] to cease di/ribution ( or recall ! drug1 z applicable4 7#f7 ,action foll[+ ord] ,any p]son :o is subject to an ord] "u p>agraph 7#a7 or 7#d7 %all imm$iately cease di/ribution ( or recall1 z applicable1 ! drug & provide notification z requir$ by su* ord]4 7b7 ,notice to consum]s & heal? (ficials ,! ,secret>y %all1 z ! ,secret>y det]m9es to be necess>y1 provide notice ( a recall ord] "u ?is section to-- 7#a7 consum]s to :om ! drug 01 or may h be51 di/ribut$2 & 7#b7 appropriate ,/ate & local heal? (ficials4 7c7 ,ord] ,to recall 7#a7 ,cont5ts ,an ord] to recall a drug "u subsection 7a7 %all-- 7,a7 require p]iodic reports to ! ,secret>y describ+ ! progress ( ! recall2 & 7,b7 provide = notice1 includ+ to individuals z appropriate1 to p]sons :o may be affect$ by ! recall4 7#b7 ,assi/ance all[$ ,9 provid+ = notice "u p>agraph 7#a77;,b71 ! ,secret>y may all[ = ! assi/ance ( heal? pr(essionals1 ,/ate or local (ficials1 or o!r individuals designat$ by ! ,secret>y4 7#c7 ,nondelegation ,an ord] "u ?is section %all be ord]$ by ! ,secret>y or an (ficial designat$ by ! ,secret>y4 ,an (ficial may n be s designat$ "u ?is section unless ! (ficial is ! ,director ( ! ,c5t] = ,drug ,evaluation & ,rese>*1 is an (ficial s5ior to su* ,director1 or is s designat$ by su* ,director4 7d7 ,sav+s clause ,no?+ conta9$ 9 ?is section %all be con/ru$ z limit+-- 7#a7 ! au?ority ( ! ,secret>y to issue an ord] to cease di/ribution (1 or to recall1 an drug "u any o!r provision ( ?is ,act or ! ,public ,heal? ,s]vice ,act2 or 7#b7 ! ability ( ! ,secret>y to reque/ any p]son to p]=m a volunt>y activity relat$ to any drug subject to ?is ,act or ! ,public ,heal? ,s]vice ,act4 4 7c7 ,drugs subject to refusal ,! ?ird s5t5ce ( subsection 7a7 ( section #hja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7 is am5d$ by ins]t+ or 7#e7 9 ! case ( a drug1 su* drug is subject to an ord] "u section #efh to cease di/ribution ( or recall ! drug1 be=e !n su* article %all be refus$ admission4 7d7 ,application ,sections #cja7;eee7 & #efi;,d ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsections 7a7 & 7b71 %all apply ) respect to a drug z ( su* date1 n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 z ! ,secret>y ( ,heal? & ,human ,s]vices %all specify4 #gajd4 ,s+le s\rce patt]n ( %ipm5ts ( adult]at$ or misbr&$ drugs ,section #hja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$ by add+ at ! end ! foll[+3 7t7 ,s+le s\rce patt]n ( %ipm5ts ( adult]at$ or misbr&$ drugs ,if ! ,secret>y id5tifies a patt]n ( adult]at$ or misbr&$ drugs be+ (f]$ = import f ! same manufactur]1 di/ributor1 or import]1 ! ,secret>y may by ord] *oose to treat all drugs be+ (f]$ = import f su* manufactur]1 di/ributor1 or import] z adult]at$ or misbr&$ unless o!rwise demon/rat$4 4 #gaje4 ,fund to /r5g!n ef=ts ( ,,fda to combat ! opioid & sub/ance use epidemic ,*apt] ,x ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cia et seq47 is am5d$ by add+ at ! end ! foll[+3 #ajae4 ,fund to /r5g!n ef=ts ( ,,fda to combat ! opioid & sub/ance use epidemic 7a7 ,9 g5]al ,! ,commission] ( ,food & ,drugs %all use any funds appropriat$ pursuant to ! au?orization ( appropriations "u subsection 7c7 to c>ry out ! programs & activities describ$ 9 subsection 7d7 to /r5g!n & facilitate ! ,food & ,drug ,adm9i/ration's ef=ts to address ! opioid & sub/ance use epidemic4 ,su* funds %all be 9 addition to any funds :i* are o!rwise available to c>ry out su* programs & activities4 7b7 ,,fda ,opioid & ,sub/ance ,use ,epidemic ,response ,fund 7#a7 ,e/abli%m5t ( fund ,!re is e/abli%$ 9 ! ,treasury a fund1 to be kn[n z ! ,,fda ,opioid & ,sub/ance ,use ,epidemic ,response ,fund 7ref]r$ to 9 ?is subsection z ! ,fund71 = purposes ( fund+ ! programs & activities describ$ 9 subsection 7d74 7#b7 ,transf] ,= ! p]iod ( fiscal ye>s #bjai ?r\gh #bjbc1 #aaj1jjj1jjj %all be transf]r$ to ! ,fund f ! g5]al fund ( ! ,treasury4 7#c7 ,am\nts deposit$ ,any am\nts transf]r$ "u p>agraph 7#b7 %all rema9 unavailable 9 ! ,fund until su* am\nts are appropriat$ pursuant to subsection 7c74 7c7 ,appropriations 7#a7 ,au?orization ( appropriations ,= ! p]iod ( fiscal ye>s #bjai ?r\gh #bjbc1 !re is au?oriz$ to be appropriat$ f ! ,fund to ! ,food & ,drug ,adm9i/ration1 = ! purpose ( c>ry+ out ! programs & activities describ$ 9 subsection 7d71 an am\nt n to exce$ ! total am\nt transf]r$ to ! ,fund "u subsection 7b77#b74 ,not)/&+ subsection 7g71 su* funds %all rema9 available until exp5d$4 7#b7 ,(fsett+ future appropriations ,= any ( fiscal ye>s #bjai ?r\gh #bjbc1 = any discretion>y appropriation out ( ! ,fund to ! ,food & ,drug ,adm9i/ration pursuant to ! au?orization ( appropriations "u p>agraph 7#a7 = ! purpose ( c>ry+ out ! programs & activities describ$ 9 subsection 7d71 ! total am\nt ( su* appropriations = ! applicable fiscal ye> 7n to exce$ ! total am\nt rema9+ 9 ! ,fund7 %all be subtract$ f ! e/imate ( discretion>y budget au?ority & ! result+ outlays = any e/imate "u ! ,congressional ,budget & ,imp\ndm5t ,control ,act ( #aigd or ! ,balanc$ ,budget & ,em]g5cy ,deficit ,control ,act ( #aihe1 & ! am\nt transf]r$ to ! ,fund %all be r$uc$ by ! same am\nt4 7d7 ,food & ,drug ,adm9i/ration ,! entirety ( ! funds made available pursuant to subsection 7c77#a7 %all be = ! ,commission] ( ,food & ,drugs1 pursuant to applicable au?orities 9 ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bja et seq47 or ?is ,act & o!r applicable ,f$]al law1 to support widespread innovation 9 non-opioid & non-addictive m$ical products = pa9 treatm5t1 access to opioid addiction treatm5ts1 appropriate use ( approv$ opioids1 & ef=ts to r$uce illicit importation ( opioids4 ,su* support may include ! foll[+ programs & activities3 7#a7 ,obligat+ contract funds beg9n+ 9 fiscal ye> #bjai = an educational campaign t w-- 7,a7 educate pati5ts & _! families to diff]5tiate opioid m$ications2 7,b7 raise aw>5ess ab\t pref]r$ /orage & disposal me?ods2 & 7,c7 in=m pati5ts1 families1 & communities ab\t m$ication-assi/$ treatm5t options4 7#b7 ,build+ ! ,food & ,drug ,adm9i/ration's pres5ce 9 int]national mail facilities1 includ+ ?r\gh-- 7,a7 improvem5ts 9 equipm5t & in=mation te*nology enhancem5ts to id5tify unapprov$1 c\nt]feit1 or o!r unlawful ph>maceuticals = de/ruction2 7,b7 increas$ & improv$ surveillance2 7,c7 r5ovations at int]national mail facility locations2 & 7,d7 ! pur*ase ( laboratory equipm5t4 7#c7 ,enhanc+ ! id5tification & t>get+ ( entities (f]+ products & products be+ (f]$ by su* entities = import into ! ,unit$ ,/ates ?r\gh review & analysis ( ,int]net websites1 import data1 & o!r s\rces ( intellig5ce = purposes ( mak+ ! be/ use ( ! ,food & ,drug ,adm9i/ration's inspection & analytical res\rces4 7#d7 ,increas+ ! numb] ( /aff ( ! ,food & ,drug ,adm9i/ration to increase ! numb] ( packages be+ exam9$1 ensur+ ! safety ( ! /aff und]tak+ su* exam9ations1 & ensur+ t packages id5tifi$ z illegal1 c\nt]feit1 misbr&$1 or adult]at$ are remov$ f comm]ce ?r\gh available au?orities1 includ+ adm9i/rative de/ruction4 7#e7 ,enhanc+ ! ,food & ,drug ,adm9i/ration's crim9al inve/igations res\rces 7includ+ full-"t equival5t employees & equipm5t71 imports surveillance1 & int]national "w4 7#f7 ,obta9+ = ! ,food & ,drug ,adm9i/ration equipm5t & full-"t equival5t employees ne$$ to effici5tly scre5 & analyze products (f]$ = import1 includ+ by build+ data libr>ies ( new sub/ances & analogues to facilitate id5tification & evaluation ( ph>maceutical-bas$ ag5ts & by pur*as+ scre5+ te*nologies = use at int]national mail facilities4 7#g7 ,op]at+ ! ,food & ,drug ,adm9i/ration's =5sic laboratory facility to ensure adequate laboratory space & functionality = additional "w & full-"t equival5t employees4 7e7 ,acc\ntability & ov]sight 7#a7 ,"w plan 7,a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,commission] ( ,food & ,drugs %all submit to ! ,committee on ,heal?1 ,education1 ,labor & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 a "w plan includ+ ! propos$ allocation ( funds appropriat$ pursuant to ! au?orization ( appropriations "u subsection 7c7 = ea* ( fiscal ye>s #bjai ?r\gh #bjbc & ! cont5ts describ$ 9 subp>agraph 7,b74 7,b7 ,cont5ts ,! "w plan submitt$ "u subp>agraph 7,a7 %all include-- 7i7 ! am\nt ( money to be obligat$ or exp5d$ out ( ! ,fund 9 ea* fiscal ye> = ea* program & activity describ$ 9 subsection 7d72 & 7ii7 a description & ju/ification ( ea* su* program & activity4 7#b7 ,reports 7,a7 ,annual reports ,n lat] ?an ,octob] #a ( ea* ( fiscal ye>s #bjbj ?r\gh #bjbd1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ! ,committee on ,heal?1 ,education1 ,labor & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report t includes-- 7i7 ! am\nt ( money obligat$ or exp5d$ out ( ! ,fund 9 ! prior fiscal ye> = ea* program & activity describ$ 9 subsection 7d72 7ii7 a description ( all programs & activities us+ funds provid$ pursuant to ! au?orization ( appropriations "u subsection 7c72 & 7iii7 h[ ! programs & activities are advanc+ public heal?4 7,b7 ,additional reports ,at ! reque/ ( ! ,committee on ,heal?1 ,education1 ,labor & ,p5sions ( ! ,s5ate or ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 ! ,commission] %all provide an update 9 ! =m ( te/imony & any additional reports to ! respective congressional committee reg>d+ ! allocation ( fund+ "u ?is section or ! description ( ! programs & activities und]tak5 ) su* fund+4 7f7 ,limitations ,not)/&+ any transf] au?ority au?oriz$ by ?is section or any appropriations ,act1 any funds made available pursuant to ! au?orization ( appropriations "u subsection 7c7 may n be us$ = any purpose o!r ?an ! programs & activities describ$ 9 subsection 7d7 to /r5g!n & facilitate ! ,food & ,drug ,adm9i/ration's ef=ts to address ! opioid & sub/ance use epidemic4 7g7 ,sunset ,?is section %all expire on ,septemb] #cj1 #bjbb1 except t-- 7#a7 ?is subsection does n apply to report+ "u subsection 7e77#b72 & 7#b7 ?is section %all rema9 9 effect until su* "t1 & to su* ext5t1 z may be necess>y = ! funds transf]r$ by subsection 7b77#b7 to be fully exp5d$4 4 #gajf4 ,consid]ation ( pot5tial = misuse & abuse requir$ = drug approval 7a7 ,9 g5]al ,section #eje7;d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;d77 is am5d$-- 7#a7 9 ! fir/ s5t5ce-- 7,a7 by /rik+ or 7#g7 & ins]t+ 7#g72 & 7,b7 by ins]t+ or 7#h7 if ! drug is or conta9s a controll$ sub/ance = :i* a li/+ 9 any s*$ule is 9 effect "u ! ,controll$ ,sub/ances ,act or t is p]man5tly s*$ul$ pursuant to section #bja ( su* ,act1 on ! basis ( in=mation submitt$ to him z "p ( ! application1 or ^u ! basis ( any o!r in=mation be=e him ) respect to su* drug1 ! drug is unsafe = use due to ! risks ( abuse or misuse or !re is insuffici5t in=mation to %[ t ! drug is safe = use consid]+ su* risks2 be=e he %all issue an ord] refus+ to approve ! application2 & 7#b7 9 ! second s5t5ce1 by /rik+ 7#f7 & ins]t+ 7#h74 7b7 ,)drawal au?ority ,section #eje7;e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;e77 is am5d$ 9 ! fir/ s5t5ce-- 7#a7 by /rik+ or 7#e7 & ins]t+ 7#e72 & 7#b7 by ins]t+ ! foll[+3 2 or 7#f7 t1 9 ! case ( a drug t is or conta9s a controll$ sub/ance = :i* a li/+ 9 any s*$ule is 9 effect "u ! ,controll$ ,sub/ances ,act or t is p]man5tly s*$ul$ pursuant to section #bja ( su* ,act1 on ! basis ( new in=mation be=e him ) respect to su* drug1 evaluat$ toge!r ) ! in=mation available to him :5 ! application 0 approv$1 t ! drug is unsafe = use due to ! risks ( abuse or misuse aft] ( a mat]ial fact4 7c7 ,rule ( con/ruction ,no?+ 9 ! am5dm5ts made by ?is section %all be con/ru$ to limit or n>r[1 9 any mann]1 ! mean+ or application ( ! provisions ( p>agraphs 7#a71 7#b71 7#c71 7#d71 7#e71 & 7#g7 ( section #eje7;d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;d77 or p>agraphs 7#a7 & 7#b7 ( section #eje7;e7 ( su* ,act 7#ba ,u4,s4,c4 #cee7;e774 ,l ,treatm5t1 ,education1 & ,community ,help to ,combat ,addiction #gaaa4 ,%ort title ,?is subtitle may be cit$ z ! ,treatm5t1 ,education1 & ,community ,help to ,combat ,addiction ,act ( #bjah or ! ,,tea* to ,combat ,addiction ,act ( #bjah4 #gaab4 ,e/abli%m5t ( ,regional ,c5t]s ( ,excell5ce 9 ,sub/ance ,use ,disord] ,education ,"p ,d ( title ,v ( ! ,public ,heal? ,s]vice ,act is am5d$ by ins]t+ aft] section #edi 7#db ,u4,s4,c4 #bij;ee-#d7 ! foll[+ new section3 #eej4 ,regional ,c5t]s ( ,excell5ce 9 ,sub/ance ,use ,disord] ,education 7a7 ,9 g5]al ,! ,secret>y1 9 consultation ) su* o!r ag5cies z are appropriate1 %all1 subject to ! availability ( appropriations1 e/abli% a solicitation process & aw>d coop]ative agreem5ts to eligible entities = ! designation ( su* entities z ,regional ,c5t]s ( ,excell5ce 9 ,sub/ance ,use ,disord] ,education & support ( su* regional c5t]s ( excell5ce to enhance & improve h[ heal? pr(essionals are educat$ 9 sub/ance use disord] prev5tion1 treatm5t1 & recov]y ?r\gh developm5t1 evaluation1 & di/ribution ( evid5ce-bas$ curricula = heal? pr(ession s*ools4 ,an eligible entity designat$ by ! ,secret>y z a ,regional ,c5t] ( ,excell5ce 9 ,sub/ance ,use ,disord] ,education %all c>ry out ! activities describ$ 9 subsection 7b74 7b7 ,selection ( c5t]s ( excell5ce 7#a7 ,eligible entities ,to be eligible to receive a coop]ative agreem5t "u subsection 7a71 an entity %all-- 7,a7 be an entity specifi$ by ! ,secret>y t (f]s education to /ud5ts 9 v>i\s heal? pr(essions1 :i* may include-- 7i7 a heal? sy/em2 7ii7 a tea*+ hospital2 7iii7 a m$ical s*ool2 7iv7 a c]tifi$ behavioral heal? cl9ic2 or 7v7 any o!r heal? pr(ession s*ool1 s*ool ( public heal?1 or ,coop]ative ,ext5sion ,program at in/itutions ( high] education engag$ 9 an aspect ( ! prev5tion1 treatm5t1 or recov]y ( sub/ance use disord]s2 7,b7 be accr$it$ by ! appropriate educational accr$itation body2 7,c7 demon/rate an exi/+ /rategy1 & h 9 place a plan = cont9u+ su* /rategy1 or a propos$ /rategy to implem5t a curriculum bas$ on be/ practices = sub/ance use disord] prev5tion1 treatm5t1 & recov]y2 7,d7 demon/rate community engagem5t & p>ticipation ?r\gh community p>tn]s1 includ+ o!r heal? pr(ession s*ools1 m5tal heal? c\nselors1 social work]s1 pe] recov]y speciali/s1 sub/ance use treatm5t programs1 community heal? c5t]s1 physicians' (fices1 c]tifi$ behavioral heal? cl9ics1 law en=cem5t1 & ! bus9ess community2 & 7,e7 provide to ! ,secret>y su* in=mation1 at su* "t1 & 9 su* mann]1 z ! ,secret>y may require4 7#b7 ,div]sity ,9 aw>d+ coop]ative agreem5ts "u subsection 7a71 ! ,secret>y %all take into acc\nt regional diff]5ces among eligible entities & %all make an ef=t to ensure geographic div]sity4 7c7 ,dissem9ation ( in=mation 7#a7 ,public po/+ ,! ,secret>y %all make in=mation provid$ to ! ,secret>y "u subsection 7b77#a77;,e7 publically available on ! ,int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7#b7 ,evaluation ,! ,secret>y %all evaluate ea* project c>ri$ out by a ,regional ,c5t] ( ,excell5ce 9 ,sub/ance ,use ,disord] ,education "u ?is section & %all dissem9ate ! f9d+s ) respect to ea* su* evaluation to appropriate public & private entities4 7d7 ,fund+ ,!re is au?oriz$ to be appropriat$ to c>ry out ?is section1 #d1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc4 4 ,m ,guidance f ,national ,m5tal ,heal? & ,sub/ance ,use ,policy ,laboratory #gaba4 ,guidance f ,national ,m5tal ,heal? & ,sub/ance ,use ,policy ,laboratory ,section #eja;,a7b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;aa-#j7;b77 is am5d$-- 7#a7 9 p>agraph 7#e71 by /rik+ & at ! end2 7#b7 9 p>agraph 7#f71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7#g7 issue & p]iodically update guidance = entities apply+ = grants f ! ,sub/ance ,abuse & ,m5tal ,heal? ,s]vices ,adm9i/ration 9 ord] to-- 7,a7 enc\rage ! fund+ ( evid5ce-bas$ practices2 7,b7 enc\rage ! replication ( promis+ or effective practices2 & 7,c7 in=m applicants on h[ to be/ articulate ! rationale = ! fund+ ( a program or activity4 4 ,n ,compreh5sive ,opioid ,recov]y ,c5t]s #gaca4 ,%ort title ,?is subtitle may be cit$ z ! ,compreh5sive ,opioid ,recov]y ,c5t]s ,act ( #bjah4 #gacb4 ,compreh5sive opioid recov]y c5t]s 7a7 ,9 g5]al ,"p ,d ( title ,v ( ! ,public ,heal? ,s]vice ,act is am5d$ by add+ at ! end ! foll[+ new section3 #eej4 ,compreh5sive opioid recov]y c5t]s 7a7 ,9 g5]al ,! ,secret>y %all aw>d grants on a competitive basis to eligible entities to e/abli% or op]ate a compreh5sive opioid recov]y c5t] 7ref]r$ to 9 ?is section z a ,c5t]74 7b7 ,grant p]iod 7#a7 ,9 g5]al ,a grant aw>d$ "u subsection 7a7 %all be = a p]iod n less ?an #c ye>s & n m ?an #e ye>s4 7#b7 ,r5ewal ,a grant aw>d$ "u subsection 7a7 may be r5ew$1 on a competitive basis1 = additional p]iods ( "t1 z det]m9$ by ! ,secret>y4 ,9 det]m9+ :e!r to r5ew a grant "u ?is p>agraph1 ! ,secret>y %all consid] ! data submitt$ "u subsection 7h74 7c7 ,m9imum numb] ( ,c5t]s ,! ,secret>y %all allocate ! am\nts made available "u subsection 7i7 9 su* am\nts t n few] ?an #aj ,c5t]s w be e/abli%$ across ! ,unit$ ,/ates4 7d7 ,application ,9 ord] to be eligible = a grant "u subsection 7a71 an entity %all submit an application to ! ,secret>y at su* "t & 9 su* mann] z ! ,secret>y may require4 ,su* application %all include-- 7#a7 evid5ce t su* entity c>ries out1 or is capable ( coord9at+ ) o!r entities to c>ry out1 ! activities describ$ 9 subsection 7g72 & 7#b7 su* o!r in=mation z ! ,secret>y may require4 7e7 ,priority ,9 aw>d+ grants "u subsection 7a71 ! ,secret>y %all give priority to eligible entities locat$ 9 a ,/ate or ,indian c\ntry 7z def9$ 9 section #aaea ( title #ah1 ,unit$ ,/ates ,code7-- 7#a7 ) a high p] capita drug ov]dose mortality rate1 z det]m9$ by ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion2 or 7#b7 bas$ on any o!r crit]ia or ne$1 z det]m9$ by ! ,secret>y4 7f7 ,use ( grant funds ,an eligible entity aw>d$ a grant "u subsection 7a7 %all use ! grant funds to e/abli% or op]ate a ,c5t] to c>ry out ! activities describ$ 9 subsection 7g74 7g7 ,c5t] activities & s]vices ,ea* ,c5t] %all1 at a m9imum1 c>ry out ! activities describ$ 9 ?is subsection4 ,9 ! case ( a ,c5t] t det]m9es t a s]vice describ$ 9 p>agraph 7#b7 _c reasonably be c>ri$ out by ! ,c5t]1 su* ,c5t] %all contract ) su* o!r entities z may be necess>y to ensure t pati5ts h access to ! full range ( s]vices describ$ 9 su* p>agraph4 7#a7 ,community outrea* ,ea* ,c5t] %all c>ry out ! foll[+ outrea* activities3 7,a7 ,tra9 & sup]vise outrea* /aff to "w ) s*ools1 workplaces1 fai?-bas$ organizations1 ,/ate & local heal? dep>tm5ts1 law en=cem5t1 & fir/ respond]s to ensure t su* in/itutions are aw>e ( ! s]vices ( ! ,c5t]4 7,b7 ,dissem9ate & make available onl9e evid5ce-bas$ res\rces t educate pr(essionals & ! public on opioid use disord] & o!r sub/ance use disord]s4 7#b7 ,treatm5t & recov]y s]vices ,ea* ,c5t] %all provide ! foll[+ treatm5t & recov]y s]vices3 7,a7 ,ensure t intake evaluations meet ! cl9ical ne$s ( pati5ts4 7,b7 ,p]iodically conduct pati5t assessm5ts to ensure cont9u$ & mean+ful recov]y1 z def9$ by ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use4 7,c7 ,provide ! full cont9uum ( treatm5t s]vices1 includ+-- 7i7 all drugs approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act & all biological products lic5s$ "u section #cea ( ?is ,act1 includ+ me?adone1 to treat sub/ance use disord]s1 includ+ opioid use disord] & alcohol use disord]2 7ii7 )drawal managem5t1 :i* %all include m$ically sup]vis$ detoxification t includes pati5t evaluation1 /abilization1 & read9ess = & entry into treatm5t2 7iii7 c\nsel+ & case managem5t1 includ+ c\nsel+ & recov]y s]vices = any possible co-occurr+ m5tal illness2 7iv7 resid5tial rehabilitation2 7v7 recov]y h\s+2 7vi7 community-bas$ & pe] recov]y support s]vices2 7vii7 job tra9+ & placem5t assi/ance to support re9tegration into ! work=ce2 & 7viii7 o!r be/ practices1 z det]m9$ by ! ,secret>y4 7,d7 ,adm9i/] an onsite ph>macy & provide toxicology s]vices4 7,e7 ,e/abli% & op]ate a secure & confid5tial electronic heal? in=mation sy/em4 7,f7 ,(f] family support s]vices su* z *ild c>e1 family c\nsel+1 & p>5t+ int]v5tions to help /abilize families impact$ by sub/ance use disord]4 7h7 ,data report+ & program ov]sight ,) respect to a grant aw>d$ "u subsection 7a7 to an eligible entity = a ,c5t]1 n lat] ?an #ij days aft] ! end ( ! fir/ ye> ( ! grant p]iod1 & annually !reaft] = ! duration ( ! grant p]iod 7includ+ ! duration ( any r5ewal p]iod = su* grant71 ! entity %all submit data1 z appropriate1 to ! ,secret>y reg>d+-- 7#a7 ! programs & activities fund$ by ! grant2 7#b7 heal? outcomes ( individuals ) a sub/ance use disord] :o receiv$ s]vices f ! ,c5t]2 7#c7 ! effectiv5ess ( int]v5tions design$1 te/$1 & evaluat$ by ! ,c5t]2 & 7#d7 any o!r in=mation t ! ,secret>y may require = ! purpose (-- 7,a7 evaluat+ ! effectiv5ess ( ! ,c5t]2 & 7,b7 ensur+ t ! ,c5t] is comply+ ) all ! requirem5ts ( ! grant1 includ+ provid+ ! full cont9uum ( s]vices describ$ 9 subsection 7g77#b77;,c7 & provid+ drugs & devices = ov]dose rev]sal "u su* subsection4 7i7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ #aj1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc = purposes ( c>ry+ out ?is section4 4 7b7 ,reports to ,congress 7#a7 ,prelim9>y report ,n lat] ?an #c ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ,congress a prelim9>y report t analyzes data submitt$ "u section #eej7;h7 ( ! ,public ,heal? ,s]vice ,act1 z add$ by subsection 7a74 7#b7 ,f9al report ,n lat] ?an #a ye> aft] submitt+ ! prelim9>y report requir$ "u p>agraph 7#a71 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ,congress a f9al report t includes-- 7,a7 an evaluation ( ! effectiv5ess ( compreh5sive opioid recov]y c5t]s e/abli%$ or op]at$ pursuant to section #eej ( ! ,public ,heal? ,s]vice ,act1 z add$ by subsection 7a72 7,b7 recomm5dations on :e!r ! grant program e/abli%$ "u su* section #eej %\ld be reau?oriz$ & exp&$2 & 7,c7 /&>ds & be/ practices = ! treatm5t ( sub/ance use disord]s1 z id5tifi$ ?r\gh su* grant program4 ,o ,poison ,c5t] ,network ,enhancem5t #gada4 ,%ort title ,?is subtitle may be cit$ z ! ,poison ,c5t] ,network ,enhancem5t ,act ( #bjah4 #gadb4 ,reau?orization ( poison control c5t]s national toll-free numb] ,section #abga ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;d-#ga7 is am5d$ to read z foll[s3 #abga4 ,e/abli%m5t & ma9t5ance ( ! national toll-free numb] & enhanc$ communications capabilities 7a7 ,9 g5]al ,! ,secret>y %all provide coord9ation & assi/ance to poison control c5t]s =-- 7#a7 ! developm5t1 e/abli%m5t1 implem5tation1 & ma9t5ance ( a nationwide toll-free phone numb]2 & 7#b7 ! enhancem5t ( communications capabilities1 :i* may include text capabilities4 7b7 ,consultation ,! ,secret>y may consult ) nationally recogniz$ pr(essional organizations 9 ! field ( poison control to det]m9e ! be/ & mo/ effective means ( a*iev+ ! goals describ$ 9 p>agraphs 7#a7 & 7#b7 ( subsection 7a74 7c7 ,rule ( con/ruction ,9 assi/+ ) public heal? em]g5cies1 responses1 or prep>$ness1 no?+ 9 ?is section %all be con/ru$ to re/rict ! "w ( poison control c5t]s or ! use ( _! res\rces by ! ,secret>y or o!r gov]nm5tal ag5cies4 7d7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ to c>ry out ?is section #gjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc4 4 #gadc4 ,reau?orization ( nationwide public aw>5ess campaign to promote poison control c5t] utilization ,section #abgb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;d-#gb7 is am5d$ to read z foll[s3 #abgb4 ,nationwide public aw>5ess campaign to promote poison control c5t] utilization & _! public heal? em]g5cy response capabilities 7a7 ,9 g5]al ,! ,secret>y %all-- 7#a7 c>ry out1 & exp& ^u1 a national public aw>5ess campaign to educate ! public & heal? c>e provid]s ab\t-- 7,a7 poison+1 toxic exposure1 & drug misuse prev5tion2 & 7,b7 ! availability ( poison control c5t] res\rces 9 local communities2 & 7#b7 z "p ( su* campaign1 highlight ! nationwide toll-free numb] & enhanc$ communications capabilities support$ "u section #abga4 7b7 ,consultation ,9 c>ry+ out & exp&+ ^u ! national campaign "u subsection 7a71 ! ,secret>y may consult ) nationally recogniz$ pr(essional organizations 9 ! field ( poison control response = ! purpose ( det]m9+ ! be/ & mo/ effective me?ods = a*iev+ public aw>5ess4 7c7 ,contract ) entity ,! ,secret>y may c>ry out subsection 7a7 by ent]+ into contracts ) "o or m public or private entities1 includ+ nationally recogniz$ pr(essional organizations 9 ! field ( poison control & national m$ia firms1 = ! developm5t & implem5tation ( ! aw>5ess campaign "u subsection 7a71 :i* may include-- 7#a7 ! developm5t & di/ribution ( poison+ & toxic exposure prev5tion1 poison control c5t]1 & public heal? em]g5cy aw>5ess & response mat]ials2 7#b7 television1 radio1 int]net1 & newspap] public s]vice ann\ncem5ts2 & 7#c7 o!r means & activities to provide = public & pr(essional aw>5ess & education4 7d7 ,evaluation ,! ,secret>y %all-- 7#a7 e/abli% basel9e measures & b5*m>ks to quantitatively evaluate ! impact ( ! nationwide public aw>5ess campaign c>ri$ out "u ?is section2 & 7#b7 on a bi5nial basis1 prep>e & submit to ! appropriate committees ( ,congress an evaluation ( ! nationwide public aw>5ess campaign4 7e7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ to c>ry out ?is section1 #hjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc4 4 #gadd4 ,reau?orization ( ! poison control c5t] grant program ,section #abgc ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;d-#gc7 is am5d$ to read z foll[s3 #abgc4 ,ma9t5ance ( ! poison control c5t] grant program 7a7 ,au?orization ( program ,! ,secret>y %all aw>d grants to poison control c5t]s accr$it$ "u subsection 7c7 7or grant$ a waiv] "u subsection 7d77 & nationally recogniz$ pr(essional organizations 9 ! field ( poison control = ! purposes (-- 7#a7 prev5t+1 & provid+ treatm5t recomm5dations =1 poison+s & toxic exposures includ+ opioid & drug misuse2 7#b7 assi/+ ) public heal? em]g5cies1 responses1 & prep>$ness2 & 7#c7 comply+ ) ! op]ational requirem5ts ne$$ to su/a9 ! accr$itation ( ! c5t] "u subsection 7c74 7b7 ,additional uses ( funds ,9 addition to ! purposes describ$ 9 subsection 7a71 a poison c5t] or pr(essional organization aw>d$ a grant "u su* subsection may also use am\nts receiv$ "u su* grant-- 7#a7 to rese>*1 e/abli%1 implem5t1 & evaluate be/ practices 9 ! ,unit$ ,/ates = poison+ prev5tion1 poison control c5t] outrea*1 opioid & drug misuse in=mation & response1 & public heal? em]g5cy1 response1 & prep>$ness programs2 7#b7 to rese>*1 develop1 implem5t1 revise1 & communicate /&>d pati5t managem5t guidel9es = commonly enc\nt]$ toxic exposures2 7#c7 to improve national toxic exposure & opioid misuse surveillance by enhanc+ coop]ative activities betwe5 poison control c5t]s 9 ! ,unit$ ,/ates & ! ,c5t]s = ,disease ,control & ,prev5tion & o!r gov]nm5tal ag5cies2 7#d7 to rese>*1 improve1 & enhance ! communications & response capability & capacity ( ! ,nation's network ( poison control c5t]s to facilitate increas$ access to ! c5t]s ?r\gh ! integration & mod]nization ( ! curr5t poison control c5t]s communications & data sy/em1 includ+ enhanc+ ! network's telephony1 int]net1 data1 & social network+ te*nologies2 7#e7 to develop1 support1 & enhance te*nology & capabilities ( nationally recogniz$ pr(essional organizations 9 ! field ( poison control to collect national poison+1 toxic occurr5ce1 & relat$ public heal? data2 7#f7 to develop initiatives to fo/] ! enhanc$ public heal? utilization ( national poison data collect$ by su* organizations2 7#g7 to support & exp& ! toxicologic exp]tise )9 poison control c5t]s2 & 7#h7 to improve ! capacity ( poison control c5t]s to answ] high volumes ( contacts & int]net communications1 & to su/a9 & enhance ! poison control c5t]'s network capability to respond dur+ times ( national crisis or o!r public heal? em]g5cies4 7c7 ,accr$itation ,except z provid$ 9 subsection 7d71 ! ,secret>y may aw>d a grant to a poison control c5t] "u subsection 7a7 only if-- 7#a7 ! c5t] has be5 accr$it$ by a nationally recogniz$ pr(essional organization 9 ! field ( poison control1 & ! ,secret>y has approv$ ! organization z hav+ 9 effect /&>ds = accr$itation t reasonably provide = ! protection ( ! public heal? ) respect to poison+2 or 7#b7 ! c5t] has be5 accr$it$ by a ,/ate gov]nm5t1 & ! ,secret>y has approv$ ! ,/ate gov]nm5t z hav+ 9 effect /&>ds = accr$itation t reasonably provide = ! protection ( ! public heal? ) respect to poison+4 7d7 ,waiv] ( accr$itation requirem5ts 7#a7 ,9 g5]al ,! ,secret>y may grant a waiv] ( ! accr$itation requirem5ts ( subsection 7c7 ) respect to a nonaccr$it$ poison control c5t] t applies = a grant "u ?is section if su* c5t] c reasonably demon/rate t ! c5t] w obta9 su* an accr$itation )9 a reasonable p]iod ( "t z det]m9$ appropriate by ! ,secret>y4 7#b7 ,r5ewal ,! ,secret>y may r5ew a waiv] "u p>agraph 7#a74 7#c7 ,limitation ,! ,secret>y may n1 aft] ! date ( enactm5t ( ! ,poison ,control ,network ,enhancem5t ,act ( #bjah1 grant to a poison control c5t] waiv]s or r5ewals t total m ?an #e ye>s4 7e7 ,supplem5t n supplant ,am\nts made available to a poison control c5t] "u ?is section %all be us$ to supplem5t & n supplant o!r ,f$]al1 ,/ate1 or local funds provid$ = su* c5t]4 7f7 ,ma9t5ance ( ef=t ,a poison control c5t]1 9 utiliz+ ! proce$s ( a grant "u ?is section1 %all ma9ta9 ! annual recurr+ exp5ditures ( ! c5t] = its activities at a level t is n less ?an #hj p]c5t ( ! av]age level ( su* recurr+ exp5ditures ma9ta9$ by ! c5t] = ! prec$+ #c fiscal ye>s = :i* a grant is receiv$4 7g7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ to c>ry out ?is section1 #bh1fjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc4 ,! ,secret>y may utilize an am\nt n to exce$ #f p]c5t ( ! am\nt appropriat$ pursuant to ! prec$+ s5t5ce = ea* fiscal ye> = coord9ation1 dissem9ation1 te*nical assi/ance1 program evaluation1 data activities1 & o!r program adm9i/ration functions1 :i* are det]m9$ by ! ,secret>y to be appropriate = c>ry+ out ! program "u ?is section4 4 ,p ,elim9at+ ,opioid ,relat$ ,infecti\s ,diseases #gaea4 ,%ort title ,?is subtitle may be cit$ z ! ,elim9at+ ,opioid ,relat$ ,infecti\s ,diseases ,act ( #bjah4 #gaeb4 ,reau?orization & expansion ( program ( surveillance & education reg>d+ infections associat$ ) illicit drug use & o!r risk factors ,section #cag,n ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;b-#ae7 is am5d$ to read z foll[s3 #cag,n4 ,surveillance & education reg>d+ infections associat$ ) illicit drug use & o!r risk factors 7a7 ,9 g5]al ,! ,secret>y may 7directly & ?r\gh grants to public & nonpr(it private entities7 provide = programs = ! foll[+3 7#a7 ,to coop]ate ) ! ,/ates & ,indian tribes 9 implem5t+ or ma9ta9+ a surveillance sy/em to det]m9e ! incid5ce ( infections commonly associat$ ) illicit drug use1 includ+ infections commonly associat$ ) injection drug use su* z viral hepatitis1 human immunodefici5cy virus1 & infective endoc>ditis1 & to assi/ ! ,/ates 9 det]m9+ ! preval5ce ( su* infections1 :i* may include ! report+ ( cases ( su* infections4 7#b7 ,to id5tify1 c\nsel1 & (f] te/+ to individuals :o are at risk ( infections z a result ( injection drug use1 receiv+ blood transfusions prior to ,july #aiib1 or o!r risk factors4 7#c7 ,to provide appropriate ref]rals = c\nsel+1 te/+1 & m$ical treatm5t ( individuals id5tifi$ "u p>agraph 7#b7 & to ensure1 to ! ext5t practicable1 ! provision ( appropriate foll[-up s]vices4 7#d7 ,to develop & dissem9ate public in=mation & education programs = ! detection & control ( infections describ$ 9 p>agraph 7#a71 ) priority giv5 to high-risk populations z det]m9$ by ! ,secret>y4 7#e7 ,to improve ! education1 tra9+1 & skills ( heal? pr(essionals 9 ! detection & control ( infections & ! coord9ation ( treatm5t ( addiction & infecti\s diseases describ$ 9 p>agraph 7#a71 ) priority giv5 to sub/ance use disord] treatm5t provid]s1 p$iatricians & o!r prim>y c>e provid]s1 ob/etrician-gynecologi/s1 infecti\s diseases cl9icians1 & ,,hiv cl9icians4 7b7 ,laboratory proc$ures ,! ,secret>y may 7directly or ?r\gh grants to public & nonpr(it private entities7 c>ry out programs to provide = improvem5ts 9 ! quality ( cl9ical-laboratory proc$ures reg>d+ infections describ$ 9 subsection 7a77#a74 7c7 ,def9itions ,9 ?is section3 7#a7 ,! t]m ,indian tribe has ! mean+ giv5 t t]m 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act4 7#b7 ,! t]m injection drug use means-- 7,a7 intrav5\s adm9i/ration ( a sub/ance 9 s*$ule ,i "u section #bjb ( ! ,controll$ ,sub/ances ,act2 7,b7 intrav5\s adm9i/ration ( a sub/ance 9 s*$ule ,,ii1 ,,iii1 ,,iv1 or ,v "u section #bjb ( ! ,controll$ ,sub/ances ,act t has n be5 approv$ = intrav5\s use "u-- 7i7 section #eje ( ! ,f$]al ,food1 ,drug & ,cosmetic ,act2 or 7ii7 section #cea ( ! ,public ,heal? ,s]vice ,act2 or 7,c7 intrav5\s adm9i/ration ( a sub/ance 9 s*$ule ,,ii1 ,,iii1 ,,iv1 or ,v "u section #bjb ( ! ,controll$ ,sub/ances ,act t has n be5 prescrib$ to ! p]son us+ ! sub/ance4 7d7 ,au?orization ( appropriations ,= ! purpose ( c>ry+ out ?is section1 !re are au?oriz$ to be appropriat$ #dj1jjj1jjj = ea* ( ! fiscal ye>s #bjai ?r\gh #bjbc4 4 ,q ,bett] ,pa9 ,managem5t ,?r\gh ,bett] ,data #gafa4 ,%ort title ,?is subtitle may be cit$ z ! ,bett] ,pa9 ,managem5t ,?r\gh ,bett] ,data ,act ( #bjah4 #gafb4 ,guidance address+ alt]native approa*es to data collection & label+ claims = opioid sp>+ 7a7 ,9 g5]al ,= purposes ( assi/+ sponsors 9 collect+ & incorporat+ opioid-sp>+ data 9 product label+1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all conduct a public meet+ & update or issue "o or m guidances 9 accordance ) subsection 7b74 7b7 ,guidance 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all update or issue "o or m guidances address+-- 7,a7 alt]native me?ods = data collection on opioid sp>+2 7,b7 alt]native me?ods = inclusion ( su* data 9 product label+2 & 7,c7 inve/igations o!r ?an cl9ical trials1 includ+ p>tially controll$ /udies & objective trials )\t mat*$ controls su* z hi/orically controll$ analyses1 op5-label /udies1 & meta-analyses1 on opioid sp>+ = inclusion 9 product label+4 7#b7 ,cont5ts ,! guidances "u p>agraph 7#a7 %all address-- 7,a7 innovative cl9ical trial designs = e?ically & effici5tly collect+ data on opioid sp>+ = inclusion 9 product label+2 7,b7 prim>y & second>y endpo9ts = ! r$uction ( opioid use :ile ma9ta9+ adequate pa9 control2 7,c7 use ( real _w evid5ce1 includ+ pati5t regi/ries1 & pati5t report$ outcomes to support inclusion ( opioid-sp>+ data 9 product label+2 & 7,d7 h[ sponsors may obta9 fe$back f ! ,secret>y relat+ to su* issues prior to-- 7i7 comm5cem5t ( su* data collection2 or 7ii7 ! submission ( result+ data to ! ,secret>y4 7#c7 ,public meet+ ,prior to updat+ or issu+ ! guidances requir$ by p>agraph 7#a71 ! ,secret>y %all consult ) /akehold]s1 includ+ repres5tatives ( regulat$ indu/ry1 academia1 pati5ts1 & provid] organizations1 ?r\gh a public meet+ to be held n lat] ?an #ab mon?s aft] ! date ( enactm5t ( ?is ,act4 7#d7 ,tim+ ,! ,secret>y %all-- 7,a7 n lat] ?an #ab mon?s aft] ! date ( ! public meet+ requir$ by p>agraph 7#c71 update or issue ! "o or m draft guidances requir$ by p>agraph 7#a72 & 7,b7 n lat] ?an #ab mon?s aft] ! date on :i* ! public comm5t p]iod = su* draft guidances closes1 f9alize su* guidances4 7c7 ,def9ition ,9 ?is section3 7#a7 ,! t]ms opioid sp>+ & opioid-sp>+ ref] to ! use ( drugs or devices 7z def9$ 9 section #bja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba77 t r$uce pa9 :ile enabl+ ! r$uction1 replacem5t1 or avoidance ( oral opioids4 7#b7 ,! t]m ,secret>y means ! ,secret>y ( ,heal? & ,human ,s]vices4 ,r ,special ,regi/ration = ,telem$ic9e ,cl>ification #gaga4 ,%ort title ,?is subtitle may be cit$ z ! ,special ,regi/ration = ,telem$ic9e ,cl>ification ,act ( #bjah4 #gagb4 ,deadl9e = int]im f9al regulations = a special regi/ration ,to engage 9 ! practice ( telem$ic9e ,section #caa7;h77#b7 ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hca7;h77#b77 is am5d$ by /rik+ ,! ,attorney ,g5]al %all1 ) ! concurr5ce ( ! ,secret>y1 promulgate regulations & ins]t+ ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,special ,regi/ration = ,telem$ic9e ,cl>ification ,act ( #bjah1 ! ,attorney ,g5]al %all1 ) ! concurr5ce ( ! ,secret>y1 promulgate int]im f9al regulations4 ,s ,pe] ,support ,communities ( ,recov]y #gaha4 ,%ort title ,?is subtitle may be cit$ z ! ,pe] ,support ,communities ( ,recov]y ,act4 #gahb4 ,build+ communities ( recov]y ,section #edg ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;ee-#b7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 ! head+1 by /rik+ ,def9ition & ins]t+ ,def9itions2 7,b7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ ,9 ?is section1 ! t]m recov]y community organization means an indep5d5t nonpr(it organization t-- & ins]t+ ,9 ?is section32 7,c7 by r$esignat+ p>agraphs 7#a7 & 7#b7 z subp>agraphs 7,a7 & 7,b71 respectively1 & mov+ su* subp>agraphs 7z s r$esignat$7 #b ems to ! "r2 7,d7 by ins]t+ be=e subp>agraph 7,a7 7z s r$esignat$7 ! foll[+3 7#a7 ,recov]y community organization ,! t]m recov]y community organization means an indep5d5t nonpr(it organization t-- 2 & 7,e7 by add+ at ! end ! foll[+3 7#b7 ,eligible entity ,! t]m eligible entity means-- 7,a7 a national nonpr(it entity focus$ on sub/ance use disord] ) a network ( local affiliates & p>tn]s t are geographically & organizationally div]se2 or 7,b7 a nonpr(it organization-- 7i7 focus$ on sub/ance use disord]2 7ii7 e/abli%$ by individuals 9 p]sonal or family recov]y2 & 7iii7 s]v+ prev5tion1 treatm5t1 recov]y1 payor1 fai?-bas$1 & crim9al ju/ice /akehold]s 9 ! implem5tation ( local addiction & recov]y initiatives4 2 7#b7 9 subsection 7b7-- 7,a7 by /rik+ ,! ,secret>y %all aw>d grants to recov]y community organizations & ins]t+ ,! ,secret>y-- 7#a7 %all aw>d grants to recov]y community organizations 2 7,b7 by /rik+ s]vices4 & ins]t+ s]vices & all[ su* organizations to use su* grant funds to c>ry out ! activities describ$ 9 subp>agraphs 7,a7 ?r\gh 7,c7 ( subsection 7c77#b72 &2 & 7,c7 by add+ at ! end ! foll[+3 7#b7 may aw>d grants to eligible entities = purposes ( e/abli%+ regional te*nical assi/ance c5t]s1 9 accordance ) subsection 7c77#b77;,d74 2 7#c7 by /rik+ subsection 7c72 7#d7 by r$esignat+ subsections 7d7 & 7e7 z subsections 7c7 & 7d71 respectively2 7#e7 9 subsection 7c7 7z s r$esignat$7-- 7,a7 9 p>agraph 7#a71 by /rik+ %all be us$ & ins]t+ to a recov]y community organization %all be us$2 7,b7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,a71 9 ! matt] prec$+ clause 7i71 by ins]t+ be=e build ! foll[+3 9 ! case ( a grant aw>d$ to a recov]y community organization12 7ii7 9 subp>agraph 7,b7-- 7,i7 by ins]t+ be=e r$uce ! foll[+3 9 ! case ( a grant aw>d$ to a recov]y community organization12 & 7,,ii7 by /rik+ & at ! end2 7iii7 9 subp>agraph 7,c7-- 7,i7 by ins]t+ be=e conduct ! foll[+3 9 ! case ( a grant aw>d$ to a recov]y community organization12 & 7,,ii7 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7iv7 by add+ at ! end ! foll[+3 7,d7 9 ! case ( a grant aw>d$ to an eligible entity1 provide = ! e/abli%m5t ( regional te*nical assi/ance c5t]s to provide regional te*nical assi/ance = ! foll[+3 7i7 ,implem5tation ( regionally driv51 pe]-deliv]$ addiction recov]y support s]vices be=e1 dur+1 aft]1 or 9 conjunction ) addiction treatm5t4 7ii7 ,e/abli%m5t ( recov]y community organizations4 7iii7 ,e/abli%m5t ( recov]y community c5t]s4 2 & 7#f7 9 subsection 7d7 7z s r$esignat$71 by ins]t+ be=e ! p]iod ! foll[+3 1 & #ae1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc4 ,t ,/op ,illicit ,drug ,importation #gaia4 ,%ort title ,?is %ort title may be cit$ z ! ,/op ,illicit ,drug ,importation ,act ( #bjah4 #gaib4 ,det5tion1 refusal1 & de/ruction ( drugs (f]$ = importation 7a7 ,articles treat$ z drugs = purposes ( importation ,section #hja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7 is am5d$ by add+ at ! end ! foll[+3 7t7 ,articles treat$ z drugs = purposes ( ?is section 7#a7 ,label$ articles ,an article %all n be treat$ z a drug pursuant to ?is subsection if-- 7,a7 an electronic import entry = su* article is submitt$ us+ an au?oriz$ electronic data int]*ange sy/em2 & 7,b7 su* article is designat$ 9 su* sy/em z a drug1 device1 diet>y supplem5t1 or o!r product t is regulat$ "u ?is ,act4 7#b7 ,articles cov]$ ,subject to p>agraph 7#a71 = purposes ( ?is section1 an article describ$ 9 ?is p>agraph may be treat$ by ! ,secret>y z a drug if x-- 7,a7 is or conta9s an +r$i5t t is an active +r$i5t t is conta9$ )9-- 7i7 a drug t has be5 approv$ "u section #eje ( ?is ,act2 or 7ii7 a biological product t has be5 approv$ "u section #cea ( ! ,public ,heal? ,s]vice ,act2 7,b7 is or conta9s an +r$i5t t is an active +r$i5t 9 a drug or biological product if-- 7i7 an inve/igational use exemption has be5 au?oriz$ = su* drug or biological product "u section #eje7;i7 ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act2 7ii7 sub/antial cl9ical inve/igation has be5 in/itut$ = su* drug or biological product2 & 7iii7 ! exi/5ce ( su* cl9ical inve/igation has be5 made public2 or 7,c7 is or conta9s a sub/ance t has a *emical /ructure t is sub/antially simil> to ! *emical /ructure ( an active +r$i5t 9 a drug or biological product describ$ 9 subp>agraph 7,a7 or 7,b74 7#c7 ,effect ,except to ! ext5t t an article may be treat$ z a drug pursuant to p>agraph 7#b71 ?is subsection %all n be con/ru$ z be>+ on or be+ relevant to ! "q ( :e!r any article is a drug z def9$ 9 section #bja7;g74 4 7b7 ,articles ( conc]n 7#a7 ,deliv]y by ,treasury to ,,hhs ,! fir/ s5t5ce ( section #hja7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a77 is am5d$ by /rik+ & cosmetics & ins]t+ cosmetics1 & pot5tial articles ( conc]n 7z def9$ 9 subsection 7u774 7#b7 ,refus$ admission ,! ?ird s5t5ce ( section #hja7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a77 is am5d$ by /rik+ !n su* article %all be refus$ admission & ins]t+ or 7#e7 su* article is an article ( conc]n 7z def9$ 9 subsection 7u771 or 7#f7 su* article is a drug t is be+ import$ or (f]$ = import 9 violation ( section #cja7;cc71 !n su* article %all be refus$ admission4 7#c7 ,def9ition ( article ( conc]n ,section #hja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha71 z am5d$1 is fur!r am5d$ by add+ at ! end ! foll[+3 7u7 ,article ( conc]n def9$ ,= purposes ( subsection 7a71 ! t]m article ( conc]n means an article t is or conta9s a drug or o!r sub/ance-- 7#a7 = :i*1 dur+ ! #bd-mon? p]iod prior to ! article be+ import$ or (f]$ = import1 ! ,secret>y ( ,heal? & ,human ,s]vices-- 7,a7 has reque/$ t1 bas$ on a det]m9ation t ! drug or o!r sub/ance appe>s to meet ! requirem5ts = tempor>y or p]man5t s*$ul+ pursuant to section #bja ( ! ,controll$ ,sub/ances ,act1 ! ,attorney ,g5]al initiate ! process to control ! drug or o!r sub/ance 9 accordance ) su* ,act2 or 7,b7 has1 foll[+ ! publication by ! ,attorney ,g5]al ( a notice 9 ! ,f$]al ,regi/] ( ! int5tion to issue an ord] tempor>ily s*$ul+ su* drug or sub/ance 9 s*$ule ,i ( section #bjb ( ! ,controll$ ,sub/ances ,act pursuant to section #bja7;h7 ( su* ,act1 made a det]m9ation t su* article pres5ts an imm95t haz>d to public safety2 & 7#b7 ) respect to :i* ! ,attorney ,g5]al has n-- 7,a7 s*$ul$ ! drug or o!r sub/ance "u su* ,act2 or 7,b7 notifi$ ! ,secret>y ( ,heal? & ,human ,s]vices t ! ,attorney ,g5]al has made a det]m9ation n to s*$ule ! drug or o!r sub/ance "u su* ,act4 4 #gaic4 ,seizure ,section #cjd7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ccd7;b77 is am5d$ by /rik+ ! fir/ s5t5ce & ins]t+ ! foll[+3 ,! article1 equipm5t1 or o!r ?+ proce$$ aga9/ %all be liable to seizure by process pursuant to ! libel1 & ! proc$ure 9 cases "u ?is section %all con=m1 z ne>ly z may be1 to ! proc$ure 9 admiralty r ?an ! proc$ure us$ = civil asset =feiture proce$+s set =? 9 section #ihc ( title #ah1 ,unit$ ,/ates ,code4 ,on dem& ( ei!r p>ty any issue ( fact jo9$ 9 any su* a case br\ght "u ?is section %all be tri$ by jury4 ,a seizure br\ght "u ?is section is n gov]n$ by ,rule ,g ( ! ,supplem5tal ,rules ( ,admiralty or ,m>itime ,claims & ,asset ,=feiture ,actions4 ,exig5t circum/ances %all be deem$ to exi/ = all seizures br\ght "u ?is section1 & 9 su* cases1 ! summons & arre/ w>rant %all be issu$ by ! cl]k ( ! c\rt )\t c\rt review4 4 #gaid4 ,deb>r+ violative individuals or companies 7a7 ,prohibit$ act ,section #cja7;cc7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7;cc77 is am5d$-- 7#a7 by ins]t+ aft] an article ( food ! foll[+3 or a drug2 & 7#b7 by ins]t+ aft] a p]son deb>r$ ! foll[+3 f su* activity4 7b7 ,deb>m5t ,section #cjf7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cce;a7b77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ p>agraph 7#b7 & ins]t+ p>agraph 7#b7 or 7#c72 7,b7 9 subp>agraph 7,b71 by /rik+ or at ! end2 7,c7 9 subp>agraph 7,c71 by /rik+ ! p]iod at ! end & ins]t+ 1 or2 & 7,d7 by add+ at ! end ! foll[+3 7,d7 a p]son f import+ or (f]+ to import into ! ,unit$ ,/ates-- 7i7 a controll$ sub/ance z def9$ 9 section #ajb7f7 ( ! ,controll$ ,sub/ances ,act2 or 7ii7 any drug1 if su* drug is decl>$ to be valu$ at an am\nt t is #b1ejj or less 7or su* high] am\nt z ! ,secret>y ( ! ,treasury may set by regulation pursuant to section #dih7;a77#a7 ( ! ,t>iff ,act ( #aicj71 or if su* drug is ent]+ ! ,unit$ ,/ates by mail4 2 & 7#b7 9 p>agraph 7#c7-- 7,a7 9 ! p>agraph head+ aft] food by ins]t+ or drug2 7,b7 by r$esignat+ subp>agraphs 7,a7 & 7,b7 z clauses 7i7 & 7ii71 respectively1 & mov+ ! ind5tation ( ea* su* clause #b ems to ! "r2 7,c7 aft] mak+ ! am5dm5ts requir$ by subp>agraph 7,b71 by /rik+ ,a p]son is subject & ins]t+ ! foll[+3 7,a7 ,food ,a p]son is subject 2 & 7,d7 by add+ at ! end ! foll[+3 7,b7 ,importation ( drugs ,a p]son is subject to deb>m5t "u p>agraph 7#a77;,d7 if-- 7i7 ! p]son has be5 convict$ ( a felony = conduct relat+ to ! importation into ! ,unit$ ,/ates ( any drug or controll$ sub/ance 7z def9$ 9 section #ajb ( ! ,controll$ ,sub/ances ,act72 or 7ii7 ! p]son has engag$ 9 a patt]n ( import+ or (f]+ = import articles ( drug t are-- 7,i7 7aa7 adult]at$1 misbr&$1 or 9 violation ( section #eje2 & 7bb7 pres5t a ?reat ( s]i\s adv]se heal? consequ5ces or dea? to humans or animals2 or 7,,ii7 controll$ sub/ances ^: importation is prohibit$ pursuant to section #dja7m7 ( ! ,t>iff ,act ( #aicj4 7,c7 ,def9ition ,= purposes ( subp>agraph 7,b71 ! t]m patt]n ( import+ or (f]+ = import articles ( drug means import+ or (f]+ = import articles ( drug describ$ 9 subclause 7,i7 or 7,,ii7 ( subp>agraph 7,b77ii7 9 an am\nt1 frequ5cy1 or dosage t is inconsi/5t ) p]sonal or h\sehold use by ! import]4 4 ,u ,creat+ ,opportunities t ,necessitate ,new & ,enhanc$ ,connections ,t ,improve ,opioid ,navigation ,/rategies #gbja4 ,%ort title ,?is subtitle may be cit$ z ! ,creat+ ,opportunities t ,necessitate ,new & ,enhanc$ ,connections ,t ,improve ,opioid ,navigation ,/rategies ,act ( #bjah or ! ,,connections ,act4 #gbjb4 ,prev5t+ ov]doses ( controll$ sub/ances ,"p ,p ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is am5d$ by add+ at ! end ! foll[+ new section3 #cii,v-#g4 ,prev5t+ ov]doses ( controll$ sub/ances 7a7 ,evid5ce-,bas$ prev5tion grants 7#a7 ,9 g5]al ,! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion may-- 7,a7 to ! ext5t practicable1 c>ry out any evid5ce-bas$ prev5tion activity describ$ 9 p>agraph 7#b72 7,b7 provide tra9+ & te*nical assi/ance to ,/ates1 localities1 & ,indian tribes = purposes ( c>ry+ out any su* activity2 & 7,c7 aw>d grants to ,/ates1 localities1 & ,indian tribes = purposes ( c>ry+ out any su* activity4 7#b7 ,evid5ce-bas$ prev5tion activities ,an evid5ce-bas$ prev5tion activity describ$ 9 ?is p>agraph is any ( ! foll[+ activities3 7,a7 ,) respect to a ,/ate1 improv+ ! effici5cy & use ( ! ,/ate prescription drug monitor+ program by-- 7i7 enc\rag+ all au?oriz$ us]s 7z specifi$ by ! ,/ate7 to regi/] ) & use ! program & mak+ ! program easi] to use2 7ii7 enabl+ su* us]s to access any updates to in=mation collect$ by ! program 9 z close to real-"t z possible2 7iii7 provid+ = a me*anism = ! program to automatically flag any pot5tial misuse or abuse ( controll$ sub/ances & any detection ( inappropriate prescrib+ practices relat+ to su* sub/ances2 7iv7 enhanc+ int]op]ability betwe5 ! program & any electronic heal? records sy/em1 includ+ by integrat+ ! use ( electronic heal? records into ! program = purposes ( improv+ cl9ical decisionmak+2 7v7 cont9ually updat+ program capabilities to respond to te*nological innovation = purposes ( appropriately address+ a controll$ sub/ance ov]dose epidemic z su* epidemic may occur & evolve2 7vi7 facilitat+ data %>+ betwe5 ! program & ! prescription drug monitor+ programs ( neighbor+ ,/ates2 & 7vii7 meet+ ! purpose ( ! program e/abli%$ "u section #cii,o1 z describ$ 9 section #cii,o7a74 7,b7 ,a*iev+ community or heal? sy/em int]v5tions ?r\gh activities su* z-- 7i7 e/abli%+ or improv+ controll$ sub/ances prescrib+ int]v5tions = insur]s & heal? sy/ems2 7ii7 enhanc+ ! use ( evid5ce-bas$ controll$ sub/ances prescrib+ guidel9es across sectors & heal? c>e sett+s2 & 7iii7 implem5t+ /rategies to align ! prescription ( controll$ sub/ances ) ! guidel9es describ$ 9 clause 7ii74 7,c7 ,evaluat+ int]v5tions to bett] und]/& :at works to prev5t ov]doses1 includ+ ^? involv+ prescription & illicit controll$ sub/ances4 7,d7 ,implem5t+ projects to advance an innovative prev5tion approa* ) respect to new & em]g+ public heal? crises & opportunities to address su* crises1 su* z enhanc+ public education & aw>5ess on ! risks associat$ ) opioids4 7b7 ,enhanc$ surveillance ( controll$ sub/ance ov]dose grants 7#a7 ,9 g5]al ,! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion may-- 7,a7 to ! ext5t practicable1 c>ry out any controll$ sub/ance ov]dose surveillance activity describ$ 9 p>agraph 7#b72 7,b7 provide tra9+ & te*nical assi/ance to ,/ates = purposes ( c>ry+ out any su* activity2 7,c7 aw>d grants to ,/ates = purposes ( c>ry+ out any su* activity2 & 7,d7 coord9ate ) ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use to collect data pursuant to section #eje7;d77#a77;,a7 7relat+ to ! numb] ( individuals admitt$ to ! em]g5cy rooms ( hospitals z a result ( ! abuse ( alcohol or o!r drugs74 7#b7 ,controll$ sub/ance ov]dose surveillance activities ,a controll$ sub/ance ov]dose surveillance activity describ$ 9 ?is p>agraph is any ( ! foll[+ activities3 7,a7 ,enhanc+ ! timel9ess ( report+ data to ! public1 includ+ data on fatal & nonfatal ov]doses ( controll$ sub/ances4 7,b7 ,enhanc+ compreh5siv5ess ( data on controll$ sub/ances ov]doses by collect+ in=mation on su* ov]doses f appropriate s\rces su* z toxicology reports1 autopsy reports1 dea? sc5e inve/igations1 & o!r risk factors4 7,c7 ,us+ data to help id5tify risk factors associat$ ) controll$ sub/ances ov]doses4 7,d7 ,) respect to a ,/ate1 support+ entities involv$ 9 provid+ in=mation to in=m ef=ts )9 ! ,/ate1 su* z by coron]s & m$ical exam9]s1 to improve accurate te/+ & report+ ( causes & contribut+ factors to controll$ sub/ances ov]doses4 7,e7 ,work+ to enable in=mation %>+ reg>d+ controll$ sub/ances ov]doses among data s\rces4 7c7 ,def9itions ,9 ?is section3 7#a7 ,controll$ sub/ance ,! t]m controll$ sub/ance has ! mean+ giv5 t t]m 9 section #ajb ( ! ,controll$ ,sub/ances ,act4 7#b7 ,indian tribe ,! t]m ,indian tribe has ! mean+ giv5 t t]m 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act4 7d7 ,au?orization ( appropriations ,= purposes ( c>ry+ out ?is section & section #cii,o1 !re is au?oriz$ to be appropriat$ #dhf1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc4 4 #gbjc4 ,prescription drug monitor+ program ,section #cii,o ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;g-#c7 is am5d$ to read z foll[s3 #cii,o4 ,prescription drug monitor+ program 7a7 ,program 7#a7 ,9 g5]al ,ea* fiscal ye>1 ! ,secret>y1 9 consultation ) ! ,director ( ,national ,drug ,control ,policy1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use1 & ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology1 %all support ,/ates = ! purpose ( improv+ ! effici5cy & use ( ,p,d,m,ps1 includ+-- 7,a7 e/abli%m5t & implem5tation ( a ,,pdmp2 7,b7 ma9t5ance ( a ,,pdmp2 7,c7 improvem5ts to a ,,pdmp by-- 7i7 enhanc+ functional compon5ts to "w t[>d-- 7,i7 univ]sal use ( ,p,d,m,ps among provid]s & _! delegates1 to ! ext5t t ,/ate laws all[1 )9 a ,/ate2 7,,ii7 m timely inclusion ( data )9 a ,,pdmp2 7,,iii7 active managem5t ( ! ,,pdmp1 9 "p by s5d+ proactive or unsolicit$ reports to provid]s to in=m prescrib+2 & 7,,iv7 ensur+ ! highe/ level ( ease 9 use & access ( ,p,d,m,ps by provid]s & _! delegates1 to ! ext5t t ,/ate laws all[2 7ii7 improv+ ! intra/ate int]op]ability ( ,p,d,m,ps by-- 7,i7 mak+ ,p,d,m,ps m actionable by integrat+ ,p,d,m,ps )9 electronic heal? records & heal? in=mation te*nology infra/ructure2 & 7,,ii7 l9k+ ,,pdmp data to o!r data sy/ems )9 ! ,/ate1 includ+-- 7aa7 ! data ( ph>macy b5efit manag]s1 m$ical exam9]s & coron]s1 & ! ,/ate's ,m$icaid program2 7bb7 work]'s comp5sation data2 & 7cc7 prescrib+ data ( provid]s ( ! ,dep>tm5t ( ,vet]ans ,affairs & ! ,indian ,heal? ,s]vice )9 ! ,/ate2 7iii7 improv+ ! int]/ate int]op]ability ( ,p,d,m,ps ?r\gh-- 7,i7 %>+ ( disp5s+ data 9 ne>-real "t across ,/ate l9es2 & 7,,ii7 integration ( automat$ qu]ies = multi/ate ,,pdmp data & analytics into cl9ical workfl[ to improve ! use ( su* data & analytics by practition]s & disp5s]s2 or 7iv7 improv+ ! ability to include treatm5t availability res\rces & ref]ral capabilities )9 ! ,,pdmp4 7#b7 ,/ate legislation ,z a condition on ! receipt ( support "u ?is section1 ! ,secret>y %all require a ,/ate to demon/rate t ! ,/ate has enact$ legislation or regulations-- 7,a7 to provide = ! implem5tation ( ! ,,pdmp2 & 7,b7 to p]mit ! imposition ( appropriate p5alties = ! unau?oriz$ use & disclosure ( in=mation ma9ta9$ by ! ,,pdmp4 7b7 ,,pdmp /rategies ,! ,secret>y %all enc\rage a ,/ate1 9 e/abli%+1 improv+1 or ma9ta9+ a ,,pdmp1 to implem5t /rategies t improve-- 7#a7 ! report+ ( disp5s+ 9 ! ,/ate ( a controll$ sub/ance to an ultimate us] s ! report+ occurs n lat] ?an #bd h\rs aft] ! disp5s+ ev5t2 7#b7 ! consultation ( ! ,,pdmp by ea* prescrib+ practition]1 or _! designee1 9 ! ,/ate be=e initiat+ treatm5t ) a controll$ sub/ance1 or any sub/ance z requir$ by ! ,/ate to be report$ to ! ,,pdmp1 & ov] ! c\rse ( ongo+ treatm5t = ea* prescrib+ ev5t2 7#c7 ! consultation ( ! ,,pdmp be=e disp5s+ a controll$ sub/ance1 or any sub/ance z requir$ by ! ,/ate to be report$ to ! ,,pdmp2 7#d7 ! proactive notification to a practition] :5 patt]ns indicative ( controll$ sub/ance misuse by a pati5t1 includ+ opioid misuse1 are detect$2 7#e7 ! availability ( data 9 ! ,,pdmp to o!r ,/ates1 z all[able "u ,/ate law2 & 7#f7 ! availability ( nonid5tifiable in=mation to ! ,c5t]s = ,disease ,control & ,prev5tion = surveillance1 epidemiology1 /ati/ical rese>*1 or educational purposes4 7c7 ,drug misuse & abuse ,9 consultation ) practition]s1 disp5s]s1 & o!r relevant & int]e/$ /akehold]s1 a ,/ate receiv+ support "u ?is section-- 7#a7 %all e/abli% a program to notify practition]s & disp5s]s ( in=mation t w help to id5tify & prev5t ! unlawful div]sion or misuse ( controll$ sub/ances2 & 7#b7 may1 to ! ext5t p]mitt$ "u ,/ate law1 notify ! appropriate au?orities responsible = c>ry+ out drug div]sion inve/igations if ! ,/ate det]m9es t in=mation 9 ! ,,pdmp ma9ta9$ by ! ,/ate indicates an unlawful div]sion or abuse ( a controll$ sub/ance4 7d7 ,evaluation & report+ ,z a condition on receipt ( support "u ?is section1 ! ,/ate %all report on int]op]ability ) ,p,d,m,ps ( o!r ,/ates & ,f$]al ag5cies1 :]e appropriate1 intra/ate int]op]ability ) heal? in=mation te*nology sy/ems su* z electronic heal? records1 heal? in=mation ex*anges1 & e-prescrib+1 :]e appropriate1 & :e!r or n ! ,/ate provides automatic1 up-to-date1 or daily in=mation ab\t a pati5t :5 a practition] 7or ! designee ( a practition]1 :]e p]mitt$7 reque/s in=mation ab\t su* pati5t4 7e7 ,evaluation & report+ ,a ,/ate receiv+ support "u ?is section %all provide ! ,secret>y ) aggregate nonid5tifiable in=mation1 z p]mitt$ by ,/ate law1 to enable ! ,secret>y-- 7#a7 to evaluate ! success ( ! ,/ate's program 9 a*iev+ ! purpose describ$ 9 subsection 7a72 or 7#b7 to prep>e & submit to ! ,congress ! report requir$ by subsection 7i77#b74 7f7 ,education & access to ! monitor+ sy/em ,a ,/ate receiv+ support "u ?is section %all take /eps to-- 7#a7 facilitate prescrib]s & disp5s]s1 & _! delegates1 z p]mitt$ by ,/ate law1 to use ! ,,pdmp1 to ! ext5t practicable2 & 7#b7 educate prescrib]s & disp5s]s1 & _! delegates on ! b5efits ( ! use ( ,p,d,m,ps4 7g7 ,electronic =mat ,! ,secret>y may issue guidel9es specify+ a uni=m electronic =mat = ! report+1 %>+1 & disclosure ( in=mation pursuant to ,p,d,m,ps4 7h7 ,rules ( con/ruction 7#a7 ,functions o!rwise au?oriz$ by law ,no?+ 9 ?is section %all be con/ru$ to re/rict ! ability ( any au?ority1 includ+ any local1 ,/ate1 or ,f$]al law en=cem5t1 n>cotics control1 lic5sure1 discipl9>y1 or program au?ority1 to p]=m functions o!rwise au?oriz$ by law4 7#b7 ,additional privacy protections ,no?+ 9 ?is section %all be con/ru$ z preempt+ any ,/ate f impos+ any additional privacy protections4 7#c7 ,f$]al privacy requirem5ts ,no?+ 9 ?is section %all be con/ru$ to sup]s$e any ,f$]al privacy or confid5tiality requirem5t1 includ+ ! regulations promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 7,public ,law #ajd-aia2 #aaj ,/at4 #bjcc7 & section #edc ( ?is ,act4 7#d7 ,no ,f$]al private cause ( action ,no?+ 9 ?is section %all be con/ru$ to create a ,f$]al private cause ( action4 7i7 ,progress report ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ! ,,connections ,act1 ! ,secret>y %all-- 7#a7 complete a /udy t-- 7,a7 det]m9es ! progress ( ,/ates 9 e/abli%+ & implem5t+ ,p,d,m,ps consi/5t ) ?is section2 7,b7 provides an analysis ( ! ext5t to :i* ! op]ation ( ,p,d,m,ps has-- 7i7 r$uc$ inappropriate use1 abuse1 div]sion (1 & ov]dose )1 controll$ sub/ances2 7ii7 e/abli%$ or /r5g!n$ initiatives to ensure l9kages to sub/ance use disord] treatm5t s]vices2 or 7iii7 affect$ pati5t access to appropriate c>e 9 ,/ates op]at+ ,p,d,m,ps2 7,c7 det]m9e ! progress ( ,/ates 9 a*iev+ int]/ate int]op]ability & intra/ate int]op]ability ( ,p,d,m,ps1 includ+ an assessm5t ( te*nical1 legal1 & f9ancial b>ri]s to su* progress & recomm5dations = address+ ^! b>ri]s2 7,d7 det]m9es ! progress ( ,/ates 9 implem5t+ ne> real-"t electronic ,p,d,m,ps2 7,e7 provides an analysis ( ! privacy protections 9 place = ! in=mation report$ to ! ,,pdmp 9 ea* ,/ate receiv+ support "u ?is section & any recomm5dations ( ! ,secret>y = additional ,f$]al or ,/ate requirem5ts = protection ( ?is in=mation2 7,f7 det]m9es ! progress ( ,/ates 9 implem5t+ te*nological alt]natives to c5traliz$ data /orage1 su* z pe]-to-pe] file %>+ or data po9t] sy/ems1 9 ,p,d,m,ps & ! pot5tial = su* alt]natives to enhance ! privacy & security ( individually id5tifiable data2 & 7,g7 evaluates ! p5alties t ,/ates h enact$ = ! unau?oriz$ use & disclosure ( in=mation ma9ta9$ 9 ,p,d,m,ps1 & ! crit]ia us$ by ! ,secret>y to det]m9e :e!r su* p5alties qualify z appropriate = purposes ( subsection 7a77#b72 & 7#b7 submit a report to ! ,congress on ! results ( ! /udy4 7j7 ,advisory c\ncil 7#a7 ,e/abli%m5t ,a ,/ate may e/abli% an advisory c\ncil to assi/ 9 ! e/abli%m5t1 improvem5t1 or ma9t5ance ( a ,,pdmp consi/5t ) ?is section4 7#b7 ,limitation ,a ,/ate may n use ,f$]al funds = ! op]ations ( an advisory c\ncil to assi/ 9 ! e/abli%m5t1 improvem5t1 or ma9t5ance ( a ,,pdmp4 7#c7 ,s5se ( ,congress ,x is ! s5se ( ! ,congress t1 9 e/abli%+ an advisory c\ncil to assi/ 9 ! e/abli%m5t1 improvem5t1 or ma9t5ance ( a ,,pdmp1 a ,/ate %\ld consult ) appropriate pr(essional bo>ds & o!r int]e/$ p>ties4 7k7 ,def9itions ,= purposes ( ?is section3 7#a7 ,! t]m controll$ sub/ance means a controll$ sub/ance 7z def9$ 9 section #ajb ( ! ,controll$ ,sub/ances ,act7 9 s*$ule ,,ii1 ,,iii1 or ,,iv ( section #bjb ( su* ,act4 7#b7 ,! t]m disp5se means to deliv] a controll$ sub/ance to an ultimate us] by1 or pursuant to ! lawful ord] (1 a practition]1 irrespective ( :e!r ! disp5s] uses ! int]net or o!r means to effect su* deliv]y4 7#c7 ,! t]m disp5s] means a physician1 ph>maci/1 or o!r p]son t disp5ses a controll$ sub/ance to an ultimate us]4 7#d7 ,! t]m int]/ate int]op]ability ) respect to a ,,pdmp means ! ability ( ! ,,pdmp to electronically %>e report$ in=mation ) ano!r ,/ate if ! in=mation conc]ns ei!r ! disp5s+ ( a controll$ sub/ance to an ultimate us] :o resides 9 su* o!r ,/ate1 or ! disp5s+ ( a controll$ sub/ance prescrib$ by a practition] ^: pr9cipal place ( bus9ess is locat$ 9 su* o!r ,/ate4 7#e7 ,! t]m intra/ate int]op]ability ) respect to a ,,pdmp means ! integration ( ,,pdmp data )9 electronic heal? records & heal? in=mation te*nology infra/ructure or l9k+ ( a ,,pdmp to o!r data sy/ems )9 ! ,/ate1 includ+ ! ,/ate's ,m$icaid program1 work]s' comp5sation programs1 & m$ical exam9]s or coron]s4 7#f7 ,! t]m nonid5tifiable in=mation means in=mation t does n id5tify a practition]1 disp5s]1 or an ultimate us] & ) respect to :i* !re is no reasonable basis to believe t ! in=mation c be us$ to id5tify a practition]1 disp5s]1 or an ultimate us]4 7#g7 ,! t]m ,,pdmp means a prescription drug monitor+ program t is ,/ate-controll$4 7#h7 ,! t]m practition] means a physician1 d5ti/1 vet]9>ian1 sci5tific inve/igator1 ph>macy1 hospital1 or o!r p]son lic5s$1 regi/]$1 or o!rwise p]mitt$1 by ! ,unit$ ,/ates or ! jurisdiction 9 :i* ! individual practices or does rese>*1 to di/ribute1 disp5se1 conduct rese>* ) respect to1 adm9i/]1 or use 9 tea*+ or *emical analysis1 a controll$ sub/ance 9 ! c\rse ( pr(essional practice or rese>*4 7#i7 ,! t]m ,/ate means ea* ( ! #ej ,/ates1 ! ,di/rict ( ,columbia1 & any commonweal? or t]ritory ( ! ,unit$ ,/ates4 7#aj7 ,! t]m ultimate us] means a p]son :o has obta9$ f a disp5s]1 & :o possesses1 a controll$ sub/ance = ! p]son's own use1 = ! use ( a memb] ( ! p]son's h\sehold1 or = ! use ( an animal own$ by ! p]son or by a memb] ( ! p]son's h\sehold4 7#aa7 ,! t]m cl9ical workfl[ means ! integration ( automat$ qu]ies = prescription drug monitor+ programs data & analytics into heal? in=mation te*nologies su* z electronic heal? record sy/ems1 heal? in=mation ex*anges1 &_/or ph>macy disp5s+ s(tw>e sy/ems1 ?us /reaml9+ provid] access ?r\gh automat$ qu]ies4 4 ,v ,secur+ ,opioids & ,unus$ ,n>cotics ) ,delib]ate ,disposal & ,packag+ #gbaa4 ,%ort title ,?is subtitle may be cit$ z ! ,secur+ ,opioids & ,unus$ ,n>cotics ) ,delib]ate ,disposal & ,packag+ ,act ( #bjah or ! ,,s\nd ,disposal & ,packag+ ,act4 #gbab4 ,improv$ te*nologies1 controls1 or measures ) respect to ! packag+ or disposal ( c]ta9 drugs 7a7 ,9 g5]al ,*apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act is am5d$ by ins]t+ aft] section #eje-a 7#ba ,u4,s4,c4 #cee-a7 ! foll[+ new section3 #eje-b4 ,safety-enhanc+ packag+ & disposal features 7a7 ,ord]s 7#a7 ,9 g5]al ,! ,secret>y may issue an ord] requir+ ! hold] ( a cov]$ application to implem5t or modify "o or m te*nologies1 controls1 or measures ) respect to ! packag+ or disposal ( "o or m drugs id5tifi$ 9 ! cov]$ application1 if ! ,secret>y det]m9es su* te*nologies1 controls1 or measures to be appropriate to help mitigate ! risk ( abuse or misuse ( su* drug or drugs1 :i* may include by r$uc+ ! availability ( unus$ drugs4 7#b7 ,prior consultation ,! ,secret>y may n issue an ord] "u p>agraph 7#a7 unless ! ,secret>y has consult$ ) relevant /akehold]s1 ?r\gh a public meet+1 work%op1 or o!rwise1 ab\t matt]s t are relevant to ! subject ( ! ord]4 7#c7 ,assur+ access & m9imiz+ burd5 ,te*nologies1 controls1 or measures requir$ "u p>agraph 7#a7 %all-- 7,a7 be comm5surate ) ! specific risk ( abuse or misuse ( ! drug li/$ 9 ! cov]$ application2 7,b7 consid]+ su* risk1 n be unduly burd5some on pati5t access to ! drug1 consid]+ 9 p>ticul> any available evid5ce reg>d+ ! expect$ or demon/rat$ public heal? impact ( su* te*nologies1 controls1 or measures2 & 7,c7 r$uce ! risk ( abuse or misuse ( su* drug4 7#d7 ,ord] cont5ts ,an ord] issu$ "u p>agraph 7#a7 may-- 7,a7 provide = a range ( options = implem5t+ or modify+ ! te*nologies1 controls1 or measures requir$ to be implem5t$ by su* ord]2 & 7,b7 incorporate by ref]5ce /&>ds reg>d+ packag+ or disposal set =? 9 an (ficial comp5dium1 e/abli%$ by a nationally or int]nationally recogniz$ /&>d developm5t organization1 or describ$ on ! public website ( ! ,food & ,drug ,adm9i/ration1 s long z ! ord] includes ! rationale = incorporation ( su* /&>d4 7#e7 ,ord]s applicable to drug class ,:5 a conc]n ab\t ! risk ( abuse or misuse ( a drug relates to a ph>macological class1 ! ,secret>y may1 aft] consultation ) relevant /akehold]s1 issue an ord] "u p>agraph 7#a7 :i* applies to ! ph>macological class4 7b7 ,compliance ,! hold] ( a cov]$ application %all-- 7#a7 submit a supplem5t conta9+ propos$ *anges to ! cov]$ application to comply ) an ord] issu$ "u subsection 7a7 n lat] ?an-- 7,a7 #ahj cal5d> days aft] ! date on :i* ! ord] is issu$2 or 7,b7 7i7 su* long] "t p]iod z specifi$ by ! ,secret>y 9 su* ord]2 or 7ii7 if a reque/ = an alt]native date is submitt$ by ! hold] ( su* application n lat] ?an #fj cal5d> days aft] ! date on :i* su* ord] is issu$-- 7,i7 su* reque/$ alt]native date if agre$ to by ! ,secret>y2 or 7,,ii7 ano!r date z specifi$ by ! ,secret>y2 & 7#b7 implem5t ! *anges approv$ pursuant to su* supplem5t n lat] ?an ! lat] (-- 7,a7 #ij cal5d> days aft] ! date on :i* ! supplem5t is approv$2 or 7,b7 ! end ( su* long] p]iod z is-- 7i7 det]m9$ to be appropriate by ! ,secret>y2 or 7ii7 approv$ by ! ,secret>y pursuant to a reque/ by ! hold] ( ! cov]$ application t expla9s :y su* long] p]iod is ne$$1 includ+ to satisfy any o!r applicable ,f$]al /atutory or regulatory requirem5ts4 7c7 ,alt]native measures ,! hold] ( ! cov]$ application may propose1 & ! ,secret>y %all approve1 te*nologies1 controls1 or measures reg>d+ packag+1 /orage1 or disposal o!r ?an ^? specifi$ 9 ! applicable ord] issu$ "u subsection 7a71 if su* te*nologies1 controls1 or measures are support$ by data & in=mation demon/rat+ t su* alt]native te*nologies1 controls1 or measures c be expect$ to mitigate ! risk ( abuse or misuse ( ! drug or drugs involv$1 includ+ by r$uc+ ! availability ( unus$ drugs1 to at lea/ ! same ext5t z ! te*nologies1 controls1 or measures specifi$ 9 su* ord]4 7d7 ,dispute resolution ,if a dispute arises 9 connection ) a supplem5t submitt$ "u subsection 7b71 ! hold] ( ! cov]$ application may appeal a det]m9ation made ) respect to su* supplem5t us+ applicable dispute resolution proc$ures specifi$ by ! ,secret>y 9 regulations or guidance4 7e7 ,def9itions ,9 ?is section-- 7#a7 ! t]m cov]$ application means an application submitt$ "u subsection 7b7 or 7j7 ( section #eje = approval "u su* section or an application submitt$ "u section #cea ( ,public ,heal? ,s]vice ,act = approval "u su* section1 ) respect to a drug t is or conta9s an opioid = :i* a li/+ 9 s*$ule ,,ii or ,,iii 7on a tempor>y or p]man5t basis7 is 9 effect "u section #bjb ( ! ,controll$ ,sub/ances ,act2 & 7#b7 ! t]m relevant /akehold]s may include sci5tific exp]ts )9 ! drug manufactur+ indu/ry2 br& & g5]ic drug manufactur]s2 /&>d developm5t organizations2 :olesal]s & di/ributors2 pay]s2 heal? c>e provid]s2 ph>maci/s2 ph>macies2 manufactur]s2 poison c5t]s2 & repres5tatives ( ! ,national ,in/itute on ,drug ,abuse1 ! ,national ,in/itutes ( ,heal?1 ! ,c5t]s = ,disease ,control & ,prev5tion1 ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 ! ,drug ,en=cem5t ,ag5cy1 ! ,consum] ,product ,safety ,commission1 individuals :o specialize 9 treat+ addiction1 & pati5t & c>egiv] gr\ps4 4 7b7 ,prohibit$ acts ,section #eja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea7 is am5d$ by ins]t+ aft] p>agraph 7j7 ! foll[+3 7k7 ,if x is a drug approv$ "u a cov]$ application 7z def9$ 9 section #eje-b7;e771 ! hold] ( :i* does n meet ! requirem5ts ( p>agraphs 7#a7 & 7#b7 ( subsection 7b7 ( su* section4 4 7c7 ,requir$ cont5t ( an abbreviat$ new drug application ,section #eje7;j77#b77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#b77;,a77 is am5d$-- 7#a7 9 clause 7vii77,,iv71 by /rik+ & at ! end2 7#b7 9 clause 7viii71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7ix7 if ! drug is or conta9s an opioid = :i* a li/+ 9 s*$ule ,,ii or ,,iii 7on a tempor>y or p]man5t basis7 is 9 effect "u section #bjb ( ! ,controll$ ,sub/ances ,act1 in=mation to %[ t ! applicant has propos$ te*nologies1 controls1 or measures relat$ to ! packag+ or disposal ( ! drug t provide protections comp>able to ^? provid$ by ! te*nologies1 controls1 or measures requir$ = ! applicable li/$ drug "u section #eje-b1 if applicable4 4 7d7 ,gr\nds = refus+ ,to approve an abbreviat$ new drug application ,section #eje7;j77#d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#d771 is am5d$-- 7#a7 9 subp>agraph 7,j71 by /rik+ or at ! end2 7#b7 9 subp>agraph 7,k71 by /rik+ ! p]iod at ! end & ins]t+ 2 or2 & 7#c7 by add+ at ! end ! foll[+3 7,l7 if ! drug is a drug describ$ 9 p>agraph 7#b77;,a77ix7 & ! applicant has n propos$ te*nologies1 controls1 or measures relat$ to ! packag+ or disposal ( su* drug t ! ,secret>y det]m9es provide protections comp>able to ^? provid$ by ! te*nologies1 controls1 or measures requir$ = ! applicable li/$ drug "u section #eje-b4 4 7e7 ,rules ( con/ruction 7#a7 ,any label+ describ+ te*nologies1 controls1 or measures relat$ to packag+ or disposal int5d$ to mitigate ! risk ( abuse or misuse ( a drug product t is subject to an abbreviat$ new drug application1 includ+ label+ describ+ diff]5ces f ! ref]5ce li/$ drug result+ f ! application ( section #eje-b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a71 %all n be con/ru$-- 7,a7 z *anges to label+ n p]missible "u clause 7v7 ( section #eje7;j77#b77;,a7 ( su* ,act 7#ba ,u4,s4,c4 #cee7;j77#b77;,a771 or a *ange 9 ! conditions ( use prescrib$1 recomm5d$1 or sugge/$ 9 ! label+ propos$ = ! new drug "u clause 7i7 ( su* section2 or 7,b7 to preclude approval ( an abbreviat$ new drug application "u subp>agraph 7,b7 or 7,g7 ( section #eje7;j77#d7 ( su* ,act 7#ba ,u4,s4,c4 #cee7;j77#d774 7#b7 ,= a cov]$ application t is an application submitt$ "u subsection 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 subsection 7j77#b77;,a7 ( su* section #eje %all n be con/ru$ to limit ! type ( data or in=mation ! ,secret>y ( ,heal? & ,human ,s]vices may reque/ or consid] 9 connection ) mak+ any det]m9ation "u section #eje-b4 7f7 ,,gao report ,n lat] ?an #ab mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all prep>e & submit to ! ,congress a report conta9+-- 7#a7 a description ( available evid5ce1 if any1 on ! effectiv5ess ( site-(-use1 9-home controll$ sub/ance disposal products & packag+ te*nologies2 7#b7 id5tification ( ways 9 :i* su* disposal products int5d$ = use by pati5ts1 consum]s1 & o!r end us]s t are n regi/rants "u ! ,controll$ ,sub/ances ,act1 are made available to ! public & b>ri]s to ! use ( su* disposal products2 7#c7 id5tification ( ways 9 :i* packag+ te*nologies are made available to ! public & b>ri]s to ! use ( su* te*nologies2 7#d7 a description ( ,f$]al ov]sight1 if any1 ( site-(-use1 9-home controll$ sub/ance disposal products1 includ+-- 7,a7 id5tification ( ! ,f$]al ag5cies t ov]see su* products2 7,b7 id5tification ( ! me?ods ( disposal ( controll$ sub/ances recomm5d$ by ^! ag5cies = site-(-use1 9-home disposal2 & 7,c7 a description ( ! effectiv5ess ( su* recomm5dations at prev5t+ ! div]sion ( legally prescrib$ controll$ sub/ances2 7#e7 a description ( ,f$]al ov]sight1 if any1 ( controll$ sub/ance packag+ te*nologies1 includ+-- 7,a7 id5tification ( ! ,f$]al ag5cies t ov]see su* te*nologies2 7,b7 id5tification ( ! te*nologies recomm5d$ by ^! ag5cies1 includ+ unit dose packag+1 packag+ t provides a set duration1 or o!r packag+ sy/ems t may mitigate abuse or misuse2 & 7,c7 a description ( ! effectiv5ess ( su* recomm5dations at prev5t+ ! div]sion ( legally prescrib$ controll$ sub/ances2 & 7#f7 recomm5dations on-- 7,a7 :e!r site-(-use1 9-home controll$ sub/ance disposal products & packag+ te*nologies require ,f$]al ov]sight &1 if s1 :i* ag5cies %\ld be responsible = su* ov]sight &1 z applicable1 approval ( su* products or te*nologies2 & 7,b7 ! pot5tial role ( ! ,f$]al ,gov]nm5t 9 evaluat+ su* products to ensure product efficacy4 ,w ,po/approval /udy requirem5ts #gbba4 ,po/approval /udy requirem5ts 7a7 ,purposes ( /udy ,section #eje7o77#c77;,b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7o77#c77;,b77 is am5d$ by add+ at ! end ! foll[+3 7iv7 ,to assess a pot5tial r$uction 9 effectiv5ess ( ! drug = ! conditions ( use prescrib$1 recomm5d$1 or sugge/$ 9 ! label+ !re( if-- 7,i7 ! drug involv$-- 7aa7 is or conta9s a sub/ance = :i* a li/+ 9 any s*$ule is 9 effect 7on a tempor>y or p]man5t basis7 "u section #bja ( ! ,controll$ ,sub/ances ,act2 or 7bb7 is a drug t has n be5 approv$ "u ?is section or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act1 = :i* an application = su* approval or lic5sure is p5d+ or anticipat$1 & = :i* ! ,secret>y provides notice to ! sponsor t ! ,secret>y int5ds to issue a sci5tific & m$ical evaluation & recomm5d controls "u ! ,controll$ ,sub/ances ,act2 & 7,,ii7 ! pot5tial r$uction 9 effectiv5ess c\ld result 9 ! b5efits ( ! drug no long] outweigh+ ! risks4 4 7b7 ,e/abli%m5t ( requirem5t ,section #eje7o77#c77;,c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7o77#c77;,c77 is am5d$ by /rik+ su* requirem5t & all t foll[s ?r\gh safety in=mation4 & ins]t+ ! foll[+3 su* requirem5t-- 7i7 9 ! case ( a purpose describ$ 9 clause 7i71 7ii71 or 7iii7 ( subp>agraph 7,b71 only if ! ,secret>y becomes aw>e ( new safety in=mation2 & 7ii7 9 ! case ( a purpose describ$ 9 clause 7iv7 ( su* subp>agraph1 if ! ,secret>y det]m9es t new effectiv5ess in=mation exi/s4 4 7c7 ,applicability ,section #eje7o77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7o77#c77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,g7 ,applicability ,! conduct ( a /udy or cl9ical trial requir$ pursuant to ?is p>agraph = ! purpose specifi$ 9 subp>agraph 7,b77iv7 %all n be consid]$ a new cl9ical inve/igation = ! purpose ( a p]iod ( exclusivity "u clause 7iii7 or 7iv7 ( subsection 7c77#c77;,e7 or clause 7iii7 or 7iv7 ( subsection 7j77#e77;,f74 4 7d7 ,new effectiv5ess in=mation def9$ ,section #eje7o77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7o77#b77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,d7 ,new effectiv5ess in=mation ,! t]m new effectiv5ess in=mation1 ) respect to a drug t is or conta9s a controll$ sub/ance = :i* a li/+ 9 any s*$ule is 9 effect 7on a tempor>y or p]man5t basis7 "u section #bja ( ! ,controll$ ,sub/ances ,act1 means new in=mation ab\t ! effectiv5ess ( ! drug1 includ+ a new analysis ( exi/+ in=mation1 d]iv$ f-- 7i7 a cl9ical trial2 an adv]se ev5t report2 a po/approval /udy or cl9ical trial 7includ+ a /udy or cl9ical trial "u p>agraph 7#c772 7ii7 pe]-review$ biom$ical lit]ature2 7iii7 data d]iv$ f ! po/m>ket risk id5tification & analysis sy/em "u subsection 7k72 or 7iv7 o!r sci5tific data det]m9$ to be appropriate by ! ,secret>y4 4 7e7 ,con=m+ am5dm5ts ) respect to label+ *anges ,section #eje7o77#d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7o77#d77 is am5d$-- 7#a7 9 subp>agraph 7,a7-- 7,a7 9 ! head+1 by ins]t+ or new effectiv5ess aft] safety2 7,b7 by /rik+ safety in=mation & ins]t+ new safety in=mation or new effectiv5ess in=mation su*2 & 7,c7 by /rik+ believes %\ld be & ins]t+ believes *anges %\ld be made to2 7#b7 9 subp>agraph 7,b77i7-- 7,a7 by /rik+ new safety in=mation & by ins]t+ new safety in=mation or new effectiv5ess in=mation2 & 7,b7 by ins]t+ indications1 aft] box$ w>n+s12 7#c7 9 subp>agraph 7,c71 by ins]t+ or new effectiv5ess in=mation aft] safety in=mation2 & 7#d7 9 subp>agraph 7,e71 by ins]t+ or new effectiv5ess in=mation aft] safety in=mation4 7f7 ,rule ( con/ruction ,no?+ 9 ! am5dm5ts made by ?is section %all be con/ru$ to alt]1 9 any mann]1 ! mean+ or application ( ! provisions ( p>agraph 7#c7 ( section #eje7o7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7o77 ) respect to ! au?ority ( ! ,secret>y ( ,heal? & ,human ,s]vices to require a po/approval /udy or cl9ical trial = a purpose specifi$ 9 clauses 7i7 ?r\gh 7iii7 ( subp>agraph 7,b7 ( su* p>agraph 7#c7 or p>agraph 7#d7 ( su* section #eje7o7 ) respect to ! ,secret>y's au?ority to require safety label+ *anges4 ,,viii ,miscellane\s ,a ,syn!tics ,traffick+ & ,ov]dose ,prev5tion #hjja4 ,%ort title2 table ( cont5ts ,?is subtitle may be cit$ z ! ,syn!tics ,traffick+ & ,ov]dose ,prev5tion ,act ( #bjah or ,,/op ,act ( #bjah4 #hjjb4 ,cu/oms fees 7a7 ,9 g5]al ,section #acjca7;b77#i7 ( ! ,consolidat$ ,omnibus ,budget ,reconciliation ,act ( #aihe 7#ai ,u4,s4,c4 #eh;c7b77#i77 is am5d$ by add+ at ! end ! foll[+3 7,d7 7i7 ,) respect to ! process+ ( items t are s5t to ! ,unit$ ,/ates ?r\gh ! int]national po/al network by ,inb\nd ,express ,mail s]vice or ,inb\nd ,,ems 7z t s]vice is describ$ 9 ! mail classification s*$ule ref]r$ to 9 section #cfca ( title #ci1 ,unit$ ,/ates ,code71 ! foll[+ paym5ts are requir$3 7,i7 #a p] ,inb\nd ,,ems item4 7,,ii7 ,if an ,inb\nd ,,ems item is =mally ent]$1 ! fee provid$ = "u subsection 7a77#i71 if applicable4 7ii7 ,not)/&+ section #dea ( ! ,t>iff ,act ( #aicj 7#ai ,u4,s4,c4 #adea71 ! paym5ts requir$ by clause 7i71 z allocat$ pursuant to clause 7iii77,i71 %all be ! only paym5ts requir$ = reimbursem5t ( ,u4,s4 ,cu/oms & ,bord] ,protection = cu/oms s]vices provid$ 9 connection ) ! process+ ( an ,inb\nd ,,ems item4 7iii7 7,i7 ,! paym5ts requir$ by clause 7i77,i7 %all be allocat$ z foll[s3 7aa7 #ej p]c5t ( ! am\nt ( ! paym5ts %all be paid on a qu>t]ly basis by ! ,unit$ ,/ates ,po/al ,s]vice to ! ,commission] ( ,u4,s4 ,cu/oms & ,bord] ,protection 9 accordance ) regulations prescrib$ by ! ,secret>y ( ! ,treasury to reimburse ,u4,s4 ,cu/oms & ,bord] ,protection = cu/oms s]vices provid$ 9 connection ) ! process+ ( ,inb\nd ,,ems items4 7bb7 #ej p]c5t ( ! am\nt ( ! paym5ts %all be reta9$ by ! ,po/al ,s]vice to reimburse ! ,po/al ,s]vice = s]vices provid$ 9 connection ) ! cu/oms process+ ( ,inb\nd ,,ems items4 7,,ii7 ,paym5ts receiv$ by ,u4,s4 ,cu/oms & ,bord] ,protection "u subclause 7,i77aa7 %all1 9 accordance ) section #ebd ( ! ,t>iff ,act ( #aicj 7#ai ,u4,s4,c4 #aebd71 be deposit$ 9 ! ,cu/oms ,us] ,fee ,acc\nt & us$ to directly reimburse ea* appropriation = ! am\nt paid out ( t appropriation = ! co/s incurr$ 9 provid+ s]vices to int]national mail facilities4 ,am\nts deposit$ 9 accordance ) ! prec$+ s5t5ce %all be available until exp5d$ = ! provision ( su* s]vices4 7,,iii7 ,paym5ts reta9$ by ! ,po/al ,s]vice "u subclause 7,i77bb7 %all be us$ to directly reimburse ! ,po/al ,s]vice = ! co/s incurr$ 9 provid+ s]vices 9 connection ) ! cu/oms process+ ( ,inb\nd ,,ems items4 7iv7 ,beg9n+ 9 fiscal ye> #bjba1 ! ,secret>y1 9 consultation ) ! ,po/ma/] ,g5]al1 may adju/1 n m frequ5tly ?an once ea* fiscal ye>1 ! am\nt describ$ 9 clause 7i77,i7 to an am\nt comm5surate ) ! co/s ( s]vices provid$ 9 connection ) ! cu/oms process+ ( ,inb\nd ,,ems items1 consi/5t ) ! obligations ( ! ,unit$ ,/ates "u int]national agreem5ts4 4 7b7 ,con=m+ am5dm5ts ,section #acjca7;a7 ( ! ,consolidat$ ,omnibus ,budget ,reconciliation ,act ( #aihe 7#ai ,u4,s4,c4 #eh;c7a77 is am5d$-- 7#a7 9 p>agraph 7#f71 by ins]t+ 7o!r ?an an item subject to a fee "u subsection 7b77#i77;,d77 aft] cu/oms (fic]2 & 7#b7 9 p>agraph 7#aj7-- 7,a7 9 subp>agraph 7,c71 9 ! matt] prec$+ clause 7i71 by ins]t+ 7o!r ?an ,inb\nd ,,ems items describ$ 9 subsection 7b77#i77;,d77 aft] release2 & 7,b7 9 ! flu% at ! end1 by ins]t+ or ( ,inb\nd ,,ems items describ$ 9 subsection 7b77#i77;,d71 aft] 7,c714 7c7 ,effective date ,! am5dm5ts made by ?is section %all take effect on ,janu>y #a1 #bjbj4 #hjjc4 ,m&atory advance electronic in=mation = po/al %ipm5ts 7a7 ,m&atory advance electronic in=mation 7#a7 ,9 g5]al ,section #cdc7;a77#c77,k7 ( ! ,trade ,act ( #bjjb 7,public ,law #ajg-baj2 #ai ,u4,s4,c4 #bjga note7 is am5d$ to read z foll[s3 7,k7 7i7 ,! ,secret>y %all prescribe regulations requir+ ! ,unit$ ,/ates ,po/al ,s]vice to transmit ! in=mation describ$ 9 p>agraphs 7#a7 & 7#b7 to ! ,commission] ( ,u4,s4 ,cu/oms & ,bord] ,protection = int]national mail %ipm5ts by ! ,po/al ,s]vice 7includ+ %ipm5ts to ! ,po/al ,s]vice f =eign po/al op]ators t are transport$ by private c>ri]7 consi/5t ) ! requirem5ts ( ?is subp>agraph4 7ii7 ,9 prescrib+ regulations "u clause 7i71 ! ,secret>y %all impose requirem5ts = ! transmission to ! ,commission] ( in=mation describ$ 9 p>agraphs 7#a7 & 7#b7 = mail %ipm5ts describ$ 9 clause 7i7 t are comp>able to ! requirem5ts = ! transmission ( su* in=mation impos$ on simil> non-mail %ipm5ts ( c>go1 tak+ into acc\nt ! p>amet]s set =? 9 subp>agraphs 7,a7 ?r\gh 7,j74 7iii7 ,! regulations prescrib$ "u clause 7i7 %all require ! transmission ( ! in=mation describ$ 9 p>agraphs 7#a7 & 7#b7 ) respect to a %ipm5t z soon z practicable 9 relation to ! transportation ( ! %ipm5t1 consi/5t ) subp>agraph 7,h74 7iv7 ,regulations prescrib$ "u clause 7i7 %all all[ = ! requirem5ts = ! transmission to ! ,commission] ( in=mation describ$ 9 p>agraphs 7#a7 & 7#b7 = mail %ipm5ts describ$ 9 clause 7i7 to be implem5t$ 9 phases1 z appropriate1 by-- 7,i7 sett+ increm5tal t>gets = increas+ ! p]c5tage ( su* %ipm5ts = :i* in=mation is requir$ to be transmitt$ to ! ,commission]2 & 7,,ii7 tak+ into consid]ation-- 7aa7 ! risk pos$ by su* %ipm5ts2 7bb7 ! volume ( mail %ipp$ to ! ,unit$ ,/ates by or ?r\gh a p>ticul> c\ntry2 & 7cc7 ! capacities ( =eign po/al op]ators to provide t in=mation to ! ,po/al ,s]vice4 7v7 7,i7 ,not)/&+ clause 7iv71 ! ,po/al ,s]vice %all1 n lat] ?an ,decemb] #ca1 #bjah1 arrange = ! transmission to ! ,commission] ( ! in=mation describ$ 9 p>agraphs 7#a7 & 7#b7 = n less ?an #gj p]c5t ( ! aggregate numb] ( mail %ipm5ts1 includ+ #ajj p]c5t ( mail %ipm5ts f ! ,p's ,republic ( ,*9a1 describ$ 9 clause 7i74 7,,ii7 ,if ! requirem5ts ( subclause 7,i7 are n met1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! appropriate congressional committees1 n lat] ?an ,june #cj1 #bjai1 a report-- 7aa7 assess+ ! reasons = ! failure to meet ^? requirem5ts2 & 7bb7 id5tify+ recomm5dations to improve ! collection by ! ,po/al ,s]vice ( ! in=mation describ$ 9 p>agraphs 7#a7 & 7#b74 7vi77,i7 ,not)/&+ clause 7iv71 ! ,po/al ,s]vice %all1 n lat] ?an ,decemb] #ca1 #bjbj1 arrange = ! transmission to ! ,commission] ( ! in=mation describ$ 9 p>agraphs 7#a7 & 7#b7 = #ajj p]c5t ( ! aggregate numb] ( mail %ipm5ts describ$ 9 clause 7i74 7,,ii7 ,! ,commission]1 9 consultation ) ! ,po/ma/] ,g5]al1 may det]m9e to exclude a c\ntry f ! requirem5t describ$ 9 subclause 7,i7 to transmit in=mation = mail %ipm5ts describ$ 9 clause 7i7 f ! c\ntry if ! ,commission] det]m9es t ! c\ntry-- 7aa7 does n h ! capacity to collect & transmit su* in=mation2 7bb7 repres5ts a l[ risk = mail %ipm5ts t violate relevant ,unit$ ,/ates laws & regulations2 & 7cc7 acc\nts = l[ volumes ( mail %ipm5ts t c be effectively scre5$ = compliance ) relevant ,unit$ ,/ates laws & regulations ?r\gh an alt]nate means4 7,,iii7 ,! ,commission] %all1 at a m9imum on an annual basis1 re-evaluate any det]m9ation made "u subclause 7,,ii7 to exclude a c\ntry f ! requirem5t describ$ 9 subclause 7,i74 ,if1 at any "t1 ! ,commission] det]m9es t a c\ntry no long] meets ! requirem5ts "u subclause 7,,ii71 ! ,commission] may n fur!r exclude ! c\ntry f ! requirem5t describ$ 9 subclause 7,i74 7,,iv7 ,! ,commission] %all1 on an annual basis1 submit to ! appropriate congressional committees-- 7aa7 a li/ ( c\ntries ) respect to :i* ! ,commission] has made a det]m9ation "u subclause 7,,ii7 to exclude ! c\ntries f ! requirem5t describ$ 9 subclause 7,i72 & 7bb7 in=mation us$ to support su* det]m9ation ) respect to su* c\ntries4 7vii7 7,i7 ,! ,po/ma/] ,g5]al %all1 9 consultation ) ! ,commission]1 refuse any %ipm5ts receiv$ aft] ,decemb] #ca1 #bjbj1 = :i* ! in=mation describ$ 9 p>agraphs 7#a7 & 7#b7 is n transmitt$ z requir$ "u ?is subp>agraph1 except z provid$ 9 subclause 7,,ii74 7,,ii7 ,if rem$ial action is w>rant$ 9 lieu ( refusal ( %ipm5ts pursuant to subclause 7,i71 ! ,po/ma/] ,g5]al & ! ,commission] %all take rem$ial action ) respect to ! %ipm5ts1 includ+ de/ruction1 seizure1 controll$ deliv]y or o!r law en=cem5t initiatives1 or correction ( ! failure to provide ! in=mation describ$ 9 p>agraphs 7#a7 & 7#b7 ) respect to ! %ipm5ts4 7viii7 ,no?+ 9 ?is subp>agraph %all be con/ru$ to limit ! au?ority ( ! ,secret>y to obta9 in=mation relat+ to int]national mail %ipm5ts f private c>ri]s or o!r appropriate p>ties4 7ix7 ,9 ?is subp>agraph1 ! t]m appropriate congressional committees means-- 7,i7 ! ,committee on ,f9ance & ! ,committee on ,homel& ,security & ,gov]nm5tal ,affairs ( ! ,s5ate2 & 7,,ii7 ! ,committee on ,ways & ,means1 ! ,committee on ,ov]sight & ,gov]nm5t ,re=m1 & ! ,committee on ,homel& ,security ( ! ,h\se ( ,repres5tatives4 4 7#b7 ,jo9t /rategic plan on m&atory advance in=mation ,n lat] ?an #fj days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,homel& ,security & ! ,po/ma/] ,g5]al %all develop & submit to ! appropriate congressional committees a jo9t /rategic plan detail+ specific p]=mance measures = a*iev+-- 7,a7 ! transmission ( in=mation z requir$ by section #cdc7;a77#c77,k7 ( ! ,trade ,act ( #bjjb1 z am5d$ by p>agraph 7#a72 & 7,b7 ! pres5tation by ! ,po/al ,s]vice to ,u4,s4 ,cu/oms & ,bord] ,protection ( all mail t>get$ by ,u4,s4 ,cu/oms & ,bord] ,protection = inspection4 7b7 ,capacity build+ 7#a7 ,9 g5]al ,section #cdc7;a7 ( ! ,trade ,act ( #bjjb 7,public ,law #ajg-baj2 #ai ,u4,s4,c4 #bjga note7 is am5d$ by add+ at ! end ! foll[+3 7#e7 ,capacity build+ 7,a7 ,9 g5]al ,! ,secret>y1 ) ! concurr5ce ( ! ,secret>y ( ,/ate1 & 9 coord9ation ) ! ,po/ma/] ,g5]al & ! heads ( o!r ,f$]al ag5cies1 z appropriate1 may provide te*nical assi/ance1 equipm5t1 te*nology1 & tra9+ to enhance ! capacity ( =eign po/al op]ators-- 7i7 to ga!r & provide ! in=mation requir$ by p>agraph 7#c77,k72 & 7ii7 to o!rwise ga!r & provide po/al %ipm5t in=mation relat$ to-- 7,i7 t]rorism2 7,,ii7 items ! importation or introduction ( :i* into ! ,unit$ ,/ates is prohibit$ or re/rict$1 includ+ controll$ sub/ances2 & 7,,iii7 su* o!r conc]ns z ! ,secret>y det]m9es appropriate4 7,b7 ,provision ( equipm5t & te*nology ,) respect to ! provision ( equipm5t & te*nology "u subp>agraph 7,a71 ! ,secret>y may lease1 loan1 provide1 or o!rwise assi/ 9 ! deploym5t ( su* equipm5t & te*nology "u su* t]ms & conditions z ! ,secret>y may prescribe1 includ+ nonreimbursable loans or ! transf] ( own]%ip ( equipm5t & te*nology4 4 7#b7 ,jo9t /rategic plan on capacity build+ ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,homel& ,security & ! ,po/ma/] ,g5]al %all1 9 consultation ) ! ,secret>y ( ,/ate1 jo9tly develop & submit to ! appropriate congressional committees a jo9t /rategic plan-- 7,a7 detail+ ! ext5t to :i* ,u4,s4 ,cu/oms & ,bord] ,protection & ! ,unit$ ,/ates ,po/al ,s]vice are engag$ 9 capacity build+ ef=ts "u section #cdc7;a77#e7 ( ! ,trade ,act ( #bjjb1 z add$ by p>agraph 7#a72 7,b7 describ+ plans = future capacity build+ ef=ts2 & 7,c7 assess+ h[ capacity build+ has increas$ ! ability ( ,u4,s4 ,cu/oms & ,bord] ,protection & ! ,po/al ,s]vice to advance ! goals ( ?is subtitle & ! am5dm5ts made by ?is subtitle4 7c7 ,report & consultations by ,secret>y ( ,homel& ,security & ,po/ma/] ,g5]al 7#a7 ,report ,n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is ,act1 & annually !reaft] until #c ye>s aft] ! ,po/ma/] ,g5]al has met ! requirem5t "u clause 7vi7 ( subp>agraph 7,k7 ( section #cdc7;a77#c7 ( ! ,trade ,act ( #bjjb1 z am5d$ by subsection 7a77#a71 ! ,secret>y ( ,homel& ,security & ! ,po/ma/] ,g5]al %all1 9 consultation ) ! ,secret>y ( ,/ate1 jo9tly submit to ! appropriate congressional committees a report on compliance ) t subp>agraph t includes ! foll[+3 7,a7 ,an assessm5t ( ! /atus ( ! regulations requir$ to be promulgat$ "u t subp>agraph4 7,b7 ,an update reg>d+ new & exi/+ agreem5ts rea*$ ) =eign po/al op]ators = ! transmission ( ! in=mation requir$ by t subp>agraph4 7,c7 ,a summ>y ( delib]ations betwe5 ! ,unit$ ,/ates ,po/al ,s]vice & =eign po/al op]ators ) respect to issues relat+ to ! transmission ( t in=mation4 7,d7 ,a summ>y ( ! progress made 9 a*iev+ ! transmission ( t in=mation = ! p]c5tage ( %ipm5ts requir$ by t subp>agraph4 7,e7 ,an assessm5t ( ! quality ( t in=mation be+ receiv$ by =eign po/al op]ators1 z det]m9$ by ! ,secret>y ( ,homel& ,security1 & actions tak5 to improve ! quality ( t in=mation4 7,f7 ,a summ>y ( policies e/abli%$ by ! ,univ]sal ,po/al ,union t may affect ! ability ( ! ,po/ma/] ,g5]al to obta9 ! transmission ( t in=mation4 7,g7 ,a summ>y ( ! use ( te*nology to detect illicit syn!tic opioids & o!r illegal sub/ances 9 int]national mail p>cels & plann$ acquisitions & advancem5ts 9 su* te*nology4 7,h7 ,su* o!r in=mation z ! ,secret>y ( ,homel& ,security & ! ,po/ma/] ,g5]al consid] appropriate ) respect to obta9+ ! transmission ( in=mation requir$ by t subp>agraph4 7#b7 ,consultations ,n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is ,act1 & e #ahj days !reaft] until ! ,po/ma/] ,g5]al has met ! requirem5t "u clause 7vi7 ( section #cdc7;a77#c77,k7 ( ! ,trade ,act ( #bjjb1 z am5d$ by subsection 7a77#a71 to arrange = ! transmission ( in=mation ) respect to #ajj p]c5t ( ! aggregate numb] ( mail %ipm5ts describ$ 9 clause 7i7 ( t section1 ! ,secret>y ( ,homel& ,security & ! ,po/ma/] ,g5]al %all provide brief+s to ! appropriate congressional committees on ! progress made 9 a*iev+ ! transmission ( t in=mation = t p]c5tage ( %ipm5ts4 7d7 ,gov]nm5t ,acc\ntability ,(fice report ,n lat] ?an ,june #cj1 #bjai1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! appropriate congressional committees a report-- 7#a7 assess+ ! progress ( ! ,unit$ ,/ates ,po/al ,s]vice 9 a*iev+ ! transmission ( ! in=mation requir$ by subp>agraph 7,k7 ( section #cdc7;a77#c7 ( ! ,trade ,act ( #bjjb1 z am5d$ by subsection 7a77#a71 = ! p]c5tage ( %ipm5ts requir$ by t subp>agraph2 7#b7 assess+ ! quality ( ! in=mation receiv$ f =eign po/al op]ators = t>get+ purposes2 7#c7 assess+ ! specific p]c5tage ( t>get$ mail pres5t$ by ! ,po/al ,s]vice to ,u4,s4 ,cu/oms & ,bord] ,protection = inspection2 7#d7 describ+ ! co/s ( collect+ ! in=mation requir$ by su* subp>agraph 7,k7 f =eign po/al op]ators & ! co/s ( implem5t+ ! use ( t in=mation2 7#e7 assess+ ! b5efits ( receiv+ t in=mation ) respect to int]national mail %ipm5ts2 7#f7 assess+ ! feasibility ( assess+ a cu/oms fee "u section #acjca7;b77#i7 ( ! ,consolidat$ ,omnibus ,budget ,reconciliation ,act ( #aihe1 z am5d$ by section #hjjb1 on int]national mail %ipm5ts o!r ?an ,inb\nd ,express ,mail s]vice 9 a mann] consi/5t ) ! obligations ( ! ,unit$ ,/ates "u int]national agreem5ts2 & 7#g7 id5tify+ recomm5dations1 includ+ recomm5dations = legislation1 to improve ! compliance ( ! ,po/al ,s]vice ) su* subp>agraph 7,k71 includ+ an assessm5t ( :e!r ! detection ( illicit syn!tic opioids 9 ! int]national mail w\ld be improv$ by-- 7,a7 requir+ ! ,po/al ,s]vice to s]ve z ! consignee = int]national mail %ipm5ts conta9+ goods2 or 7,b7 designat+ a cu/oms brok] to act z an import] ( record = int]national mail %ipm5ts conta9+ goods4 7e7 ,te*nical correction ,section #cdc ( ! ,trade ,act ( #bjjb 7,public ,law #ajg-baj2 #ai ,u4,s4,c4 #bjga note7 is am5d$ 9 ! section head+ by /rik+ advanc$ & ins]t+ advance4 7f7 ,appropriate congressional committees def9$ ,9 ?is section1 ! t]m appropriate congressional committees means-- 7#a7 ! ,committee on ,f9ance & ! ,committee on ,homel& ,security & ,gov]nm5tal ,affairs ( ! ,s5ate2 & 7#b7 ! ,committee on ,ways & ,means1 ! ,committee on ,ov]sight & ,gov]nm5t ,re=m1 & ! ,committee on ,homel& ,security ( ! ,h\se ( ,repres5tatives4 #hjjd4 ,int]national po/al agreem5ts 7a7 ,exi/+ agreem5ts 7#a7 ,9 g5]al ,9 ! ev5t t any provision ( ?is subtitle1 or any am5dm5t made by ?is ,act1 is det]m9$ to be 9 violation ( obligations ( ! ,unit$ ,/ates "u any po/al treaty1 conv5tion1 or o!r int]national agreem5t relat$ to int]national po/al s]vices1 or any am5dm5t to su* an agreem5t1 ! ,secret>y ( ,/ate %\ld negotiate to am5d ! relevant provisions ( ! agreem5t s t ! ,unit$ ,/ates is no long] 9 violation ( ! agreem5t4 7#b7 ,rule ( con/ruction ,no?+ 9 ?is subsection %all be con/ru$ to p]mit delay 9 ! implem5tation ( ?is subtitle or any am5dm5t made by ?is subtitle4 7b7 ,future agreem5ts 7#a7 ,consultations ,be=e ent]+ into1 on or aft] ! date ( ! enactm5t ( ?is ,act1 any po/al treaty1 conv5tion1 or o!r int]national agreem5t relat$ to int]national po/al s]vices1 or any am5dm5t to su* an agreem5t1 t is relat$ to ! ability ( ! ,unit$ ,/ates to secure ! provision ( advance electronic in=mation by =eign po/al op]ators1 ! ,secret>y ( ,/ate %\ld consult ) ! appropriate congressional committees 7z def9$ 9 section #hjjc7;f774 7#b7 ,exp$it$ negotiation ( new agreem5t ,to ! ext5t t any new po/al treaty1 conv5tion1 or o!r int]national agreem5t relat$ to int]national po/al s]vices w\ld improve ! ability ( ! ,unit$ ,/ates to secure ! provision ( advance electronic in=mation by =eign po/al op]ators z requir$ by regulations prescrib$ "u section #cdc7;a77#c77,k7 ( ! ,trade ,act ( #bjjb1 z am5d$ by section #hjjc7;a77#a71 ! ,secret>y ( ,/ate %\ld exp$iti\sly conclude su* an agreem5t4 #hjje4 ,co/ rec\pm5t 7a7 ,9 g5]al ,! ,unit$ ,/ates ,po/al ,s]vice %all1 to ! ext5t practicable & o!rwise recov]able by law1 ensure t all co/s associat$ ) comply+ ) ?is subtitle & am5dm5ts made by ?is subtitle are *>g$ directly to =eign %ipp]s or =eign po/al op]ators4 7b7 ,co/s n consid]$ rev5ue ,! recov]y ( co/s "u subsection 7a7 %all n be deem$ rev5ue = purposes ( sub*apt] ,i & ,,ii ( *apt] #cf ( title #ci1 ,unit$ ,/ates ,code1 or regulations prescrib$ "u t *apt]4 #hjjf4 ,developm5t ( te*nology to detect illicit n>cotics 7a7 ,9 g5]al ,! ,po/ma/] ,g5]al & ! ,commission] ( ,u4,s4 ,cu/oms & ,bord] ,protection1 9 coord9ation ) ! heads ( o!r ag5cies z appropriate1 %all collaborate to id5tify & develop te*nology = ! detection ( illicit f5tanyl1 o!r syn!tic opioids1 & o!r n>cotics & psy*oactive sub/ances ent]+ ! ,unit$ ,/ates by mail4 7b7 ,outrea* to private sector ,! ,po/ma/] ,g5]al & ! ,commission] %all conduct outrea* to private sector entities to ga!r in=mation reg>d+ ! curr5t /ate ( te*nology to id5tify areas = innovation relat+ to ! detection ( illicit f5tanyl1 o!r syn!tic opioids1 & o!r n>cotics & psy*oactive sub/ances ent]+ ! ,unit$ ,/ates4 #hjjg4 ,civil p5alties = po/al %ipm5ts ,section #dcf ( ! ,t>iff ,act ( #aicj 7#ai ,u4,s4,c4 #adcf7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7e7 ,civil p5alties = po/al %ipm5ts 7#a7 ,civil p5alty ,a civil p5alty %all be impos$ aga9/ ! ,unit$ ,/ates ,po/al ,s]vice if ! ,po/al ,s]vice accepts a %ipm5t 9 violation ( section #cdc7;a77#c77,k77vii77,i7 ( ! ,trade ,act ( #bjjb4 7#b7 ,modification ( civil p5alty 7,a7 ,9 g5]al ,u4,s4 ,cu/oms & ,bord] ,protection %all r$uce or dismiss a civil p5alty impos$ pursuant to p>agraph 7#a7 if ,u4,s4 ,cu/oms & ,bord] ,protection det]m9es t ! ,unit$ ,/ates ,po/al ,s]vice-- 7i7 has a l[ error rate 9 compliance ) section #cdc7;a77#c77,k7 ( ! ,trade ,act ( #bjjb2 7ii7 is coop]at+ ) ,u4,s4 ,cu/oms & ,bord] ,protection ) respect to ! violation ( section #cdc7;a77#c77,k77vii77,i7 ( ! ,trade ,act ( #bjjb2 or 7iii7 has tak5 rem$ial action to prev5t future violations ( section #cdc7;a77#c77,k77vii77,i7 ( ! ,trade ,act ( #bjjb4 7,b7 ,writt5 notification ,u4,s4 ,cu/oms & ,bord] ,protection %all issue a writt5 notification to ! ,po/al ,s]vice ) respect to ea* ex]cise ( ! au?ority ( subp>agraph 7,a7 to r$uce or dismiss a civil p5alty impos$ pursuant to p>agraph 7#a74 7#c7 ,ongo+ lack ( compliance ,if ,u4,s4 ,cu/oms & ,bord] ,protection det]m9es t ! ,unit$ ,/ates ,po/al ,s]vice-- 7,a7 has repeat$ly committ$ violations ( section #cdc7;a77#c77,k77vii77,i7 ( ! ,trade ,act ( #bjjb1 7,b7 has fail$ to coop]ate ) ,u4,s4 ,cu/oms & ,bord] ,protection ) respect to violations ( section #cdc7;a77#c77,k77vii77,i7 ( ! ,trade ,act ( #bjjb1 & 7,c7 has an increas+ error rate 9 compliance ) section #cdc7;a77#c77,k7 ( ! ,trade ,act ( #bjjb1 civil p5alties may be impos$ aga9/ ! ,unit$ ,/ates ,po/al ,s]vice until corrective action1 satisfactory to ,u4,s4 ,cu/oms & ,bord] ,protection1 is tak54 4 #hjjh4 ,report on violations ( arrival1 report+1 entry1 & cle>ance requirem5ts & falsity or lack ( manife/ 7a7 ,9 g5]al ,! ,commission] ( ,u4,s4 ,cu/oms & ,bord] ,protection %all submit to ! appropriate congressional committees an annual report t conta9s ! in=mation describ$ 9 subsection 7b7 ) respect to ea* violation ( section #dcf ( ! ,t>iff ,act ( #aicj 7#ai ,u4,s4,c4 #adcf71 z am5d$ by section #hjjg1 & section #ehd ( su* ,act 7#ai ,u4,s4,c4 #aehd7 t occurr$ dur+ ! previ\s ye>4 7b7 ,in=mation describ$ ,! in=mation describ$ 9 ?is subsection is ! foll[+3 7#a7 ,! "n & address ( ! violator4 7#b7 ,! specific violation t 0 committ$4 7#c7 ,! location or port ( entry ?r\gh :i* ! items 7 transport$4 7#d7 ,an inv5tory ( ! items seiz$1 includ+ a description ( ! items & ! quantity seiz$4 7#e7 ,! location f :i* ! items orig9at$4 7#f7 ,! entity responsible = ! appreh5sion or seizure1 organiz$ by location or port ( entry4 7#g7 ,! am\nt ( p5alties assess$ by ,u4,s4 ,cu/oms & ,bord] ,protection1 organiz$ by "n ( ! violator & location or port ( entry4 7#h7 ,! am\nt ( p5alties t ,u4,s4 ,cu/oms & ,bord] ,protection c\ld h levi$1 organiz$ by "n ( ! violator & location or port ( entry4 7#i7 ,! rationale = negotiat+ l[] p5alties1 organiz$ by "n ( ! violator & location or port ( entry4 7c7 ,appropriate congressional committees def9$ ,9 ?is section1 ! t]m appropriate congressional committees means-- 7#a7 ! ,committee on ,f9ance & ! ,committee on ,homel& ,security & ,gov]nm5tal ,affairs ( ! ,s5ate2 & 7#b7 ! ,committee on ,ways & ,means1 ! ,committee on ,ov]sight & ,gov]nm5t ,re=m1 & ! ,committee on ,homel& ,security ( ! ,h\se ( ,repres5tatives4 #hjji4 ,effective date2 regulations 7a7 ,effective date ,?is subtitle & ! am5dm5ts made by ?is subtitle 7o!r ?an ! am5dm5ts made by section #hjjb7 %all take effect on ! date ( ! enactm5t ( ?is ,act4 7b7 ,regulations ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 su* regulations z are necess>y to c>ry out ?is subtitle & ! am5dm5ts made by ?is subtitle %all be prescrib$4 ,b ,recogniz+ ,e>ly ,*ildhood ,trauma ,relat$ to ,sub/ance ,abuse #hjaa4 ,%ort title ,?is subtitle may be cit$ z ! ,recogniz+ ,e>ly ,*ildhood ,trauma ,relat$ to ,sub/ance ,abuse ,act ( #bjah4 #hjab4 ,recogniz+ ,e>ly ,*ildhood ,trauma ,relat$ to ,sub/ance ,abuse 7a7 ,dissem9ation ( in=mation ,! ,secret>y ( ,heal? & ,human ,s]vices %all dissem9ate in=mation1 res\rces1 &1 if reque/$1 te*nical assi/ance to e>ly *ildhood c>e & education provid]s & pr(essionals work+ ) "y *ildr5 on-- 7#a7 ways to prop]ly recognize *ildr5 :o may be impact$ by trauma relat$ to sub/ance abuse by a family memb] or o!r adult2 & 7#b7 h[ to respond appropriately 9 ord] to provide = ! safety & well-be+ ( "y *ildr5 & _! families4 7b7 ,goals ,! in=mation1 res\rces1 & te*nical assi/ance provid$ "u subsection 7a7 %all-- 7#a7 educate e>ly *ildhood c>e & education provid]s & pr(essionals work+ ) "y *ildr5 on und]/&+ & id5tify+ ! e>ly signs & risk factors ( *ildr5 :o might be impact$ by trauma due to exposure to sub/ance abuse2 7#b7 sugge/ age-appropriate communication tools1 proc$ures1 & practices = trauma-in=m$ c>e1 includ+ ways to prev5t or mitigate ! effects ( trauma2 7#c7 provide options = respond+ to *ildr5 impact$ by trauma due to exposure to sub/ance abuse t consid] ! ne$s ( ! *ild & family1 includ+ recomm5d+ res\rces & ref]rals = evid5ce-bas$ s]vices to support su* family2 & 7#d7 promote :ole-family & multi-g5]ational approa*es to prev5t sep>ation & support re-unification ( families :5ev] possible & 9 ! be/ int]e/ ( ! *ild4 7c7 ,rule ( con/ruction ,su* in=mation1 res\rces1 & if applicable1 te*nical assi/ance1 %all n be con/ru$ to am5d ! requirem5ts "u-- 7#a7 ! ,*ild ,c>e & ,developm5t ,block ,grant ,act ( #aiij 7#db ,u4,s4,c4 #iheh et seq472 7#b7 ! ,head ,/>t ,act 7#db ,u4,s4,c4 #ihca et seq472 or 7#c7 ! ,individuals ) ,disabilities ,education ,act 7#bj ,u4,s4,c4 #adjj et seq474 ,c ,assi/+ ,/ates' ,implem5tation ( ,plans ( ,safe ,c>e #hjba4 ,%ort title ,?is subtitle may be cit$ z ! ,assi/+ ,/ates' ,implem5tation ( ,plans ( ,safe ,c>e ,act4 #hjbb4 ,assi/+ ,/ates ) implem5tation ( plans ( safe c>e 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices %all provide writt5 guidance &1 if appropriate1 te*nical assi/ance to support ,/ates 9 comply+ )1 & implem5t+1 subsections 7b77#b77;,b77iii7 & 7d77#ah7 ( section #ajf ( ! ,*ild ,abuse ,prev5tion & ,treatm5t ,act 7#db ,u4,s4,c4 #eajf;a7 9 ord] to promote bett] protections = "y *ildr5 & family-c5t]$ responses4 7b7 ,requirem5ts ,! guidance & te*nical assi/ance %all-- 7#a7 enhance ,/ates' und]/&+ ( requirem5ts & flexibilities "u ! law1 includ+ cl>ify+ key t]ms2 7#b7 address ,/ate-id5tifi$ *all5ges ) develop+1 implem5t+1 & monitor+ plans ( safe c>e2 7#c7 dissem9ate be/ practices relat$ to develop+ & implem5t+ plans ( safe c>e1 includ+ diff]5tial response1 collaboration & coord9ation1 & id5tification & deliv]y ( s]vices1 :ile recogniz+ ne$s ( diff]5t populations & v>y+ community approa*es across ,/ates2 7#d7 support collaboration betwe5 heal? c>e provid]s1 social s]vice ag5cies1 public heal? ag5cies1 & ! *ild welf>e sy/em1 to promote a family-c5t]$ treatm5t approa*2 7#e7 prev5t sep>ation & support reunification ( families if 9 ! be/ int]e/s ( ! *ild2 7#f7 recomm5d treatm5t approa*es = s]v+ infants1 pregnant wom51 & po/p>tum wom5 ^: infants may be affect$ by sub/ance use t are design$ to keep infants ) _! mo!rs & families :5ev] appropriate1 includ+ recomm5dations to enc\rage pregnant wom5 to receive heal? & o!r support s]vices dur+ pregnancy2 7#g7 support ,/ate ef=ts to develop te*nology sy/ems to manage & monitor implem5tation ( plans ( safe c>e2 & 7#h7 help ,/ates improve ! long-t]m safety & well-be+ ( "y *ildr5 & _! families4 7c7 ,con/ruction ,! guidance & te*nical assi/ance %all n be con/ru$ to am5d ! requirem5ts ( ! ,*ild ,abuse ,prev5tion & ,treatm5t ,act 7#db ,u4,s4,c4 #eaja et seq474 7d7 ,def9ition ,= purposes ( ?is section1 ! t]m ,/ate has ! mean+ giv5 su* t]m 9 section #c ( ! ,*ild ,abuse ,prev5tion & ,treatm5t ,act 7#db ,u4,s4,c4 #eaja note74 ,d ,improv+ ! ,f$]al ,response to ,families ,impact$ by ,sub/ance ,use ,disord] #hjca4 ,%ort title ,?is subtitle may be cit$ z ! ,improv+ ! ,f$]al ,response to ,families ,impact$ by ,sub/ance ,use ,disord] ,act4 #hjcb4 ,int]ag5cy ,task ,=ce to ,improve ! ,f$]al ,response to ,families ,impact$ by ,sub/ance ,use ,disord]s 7a7 ,e/abli%m5t ,!re is e/abli%$ a task =ce1 to be kn[n z ! ,int]ag5cy ,task ,=ce to ,improve ! ,f$]al ,response to ,families ,impact$ by ,sub/ance ,use ,disord]s 79 ?is section ref]r$ to z 8,task ,=ce074 7b7 ,responsibilities ,! ,task ,=ce-- 7#a7 %all id5tify1 evaluate1 & recomm5d ways 9 :i* ,f$]al ag5cies c bett] coord9ate responses to sub/ance use disord]s & ! opioid crisis2 & 7#b7 %all c>ry out ! additional duties describ$ 9 subsection 7d74 7c7 ,memb]%ip 7#a7 ,numb] & appo9tm5t ,! ,task ,=ce %all be compos$ ( #ab ,f$]al (ficials hav+ responsibility =1 or adm9i/]+ programs relat$ to1 ! duties ( ! ,task ,=ce4 ,! ,secret>y ( ,heal? & ,human ,s]vices1 ! ,secret>y ( ,education1 ! ,secret>y ( ,agriculture1 & ! ,secret>y ( ,labor %all ea* appo9t two memb]s to ! ,task ,=ce f among ! ,f$]al (ficials employ$ by ! ,dep>tm5t ( :i* !y are ! head4 ,additional ,f$]al ag5cy (ficials appo9t$ by ! ,secret>y ( ,heal? & ,human ,s]vices %all fill ! rema9+ positions ( ! ,task ,=ce4 7#b7 ,*airp]son ,! ,secret>y ( ,heal? & ,human ,s]vices %all designate a ,f$]al (ficial employ$ by ! ,dep>tm5t ( ,heal? & ,human ,s]vices to s]ve z ! *airp]son ( ! ,task ,=ce4 7#c7 ,deadl9e = appo9tm5t ,ea* memb] %all be appo9t$ to ! ,task ,=ce n lat] ?an #fj days aft] ! date ( ! enactm5t ( ?is ,act4 7#d7 ,additional ag5cy input ,! ,task ,=ce may seek input f o!r ,f$]al ag5cies & (fices ) exp]i5ce1 exp]tise1 or in=mation relevant 9 respond+ to ! opioid crisis4 7#e7 ,vacancies ,a vacancy 9 ! ,task ,=ce %all be fill$ 9 ! mann] 9 :i* ! orig9al appo9tm5t 0 made4 7#f7 ,prohibition ( comp5sation ,memb]s ( ! ,task ,=ce may n receive pay1 all[ances1 or b5efits by reason ( _! s]vice on ! ,task ,=ce4 7d7 ,duties ,! ,task ,=ce %all c>ry out ! foll[+ duties3 7#a7 ,solicit input f /akehold]s1 includ+ frontl9e s]vice provid]s1 m$ical pr(essionals1 educators1 m5tal heal? pr(essionals1 rese>*]s1 exp]ts 9 infant1 *ild1 & y\? trauma1 *ild welf>e pr(essionals1 & ! public1 9 ord] to in=m ! activities ( ! ,task ,=ce4 7#b7 ,develop a /rategy on h[ ! ,task ,=ce & p>ticipat+ ,f$]al ag5cies w collaborate1 prioritize1 & implem5t a coord9at$ ,f$]al approa* ) reg>d to respond+ to sub/ance use disord]s1 includ+ opioid misuse1 t %all include-- 7,a7 id5tify+ options = ! coord9ation ( exi/+ grants t support infants1 *ildr51 & y\?1 & _! families z appropriate1 :o h exp]i5c$1 or are at risk ( exp]i5c+1 exposure to sub/ance abuse disord]s1 includ+ opioid misuse2 & 7,b7 o!r ways to improve coord9ation1 plann+1 & communication )9 & across ,f$]al ag5cies1 (fices1 & programs1 to bett] s]ve *ildr5 & families impact$ by sub/ance use disord]s1 includ+ opioid misuse4 7#c7 ,bas$ (f ! /rategy develop$ "u p>agraph 7#b71 evaluate & recomm5d opportunities = local- & ,/ate-level p>tn]%ips1 pr(essional developm5t1 or be/ practices t-- 7,a7 are design$ to quickly id5tify & ref] *ildr5 & families1 z appropriate1 :o h exp]i5c$ or are at risk ( exp]i5c+ exposure to sub/ance abuse2 7,b7 utilize & develop p>tn]%ips ) e>ly *ildhood education programs1 local social s]vices organizations1 & heal? c>e s]vices aim$ at prev5t+ or mitigat+ ! effects ( exposure to sub/ance use disord]s1 includ+ opioid misuse2 7,c7 (f] community-bas$ prev5tion activities1 includ+ educat+ families & *ildr5 on ! effects ( exposure to sub/ance use disord]s1 includ+ opioid misuse1 & h[ to build resili5ce & cop+ skills to mitigate ^? effects2 7,d7 9 accordance ) ,f$]al privacy protections1 utilize non-p]sonally id5tifiable data f scre5+s1 ref]rals1 or ! provision ( s]vices & supports to evaluate & improve processes address+ exposure to sub/ance use disord]s1 includ+ opioid misuse2 & 7,e7 are design$ to prev5t sep>ation & support reunification ( families if 9 ! be/ int]e/ ( ! *ild4 7#d7 ,9 fulfill+ ! requirem5ts ( p>agraphs 7#b7 & 7#c71 consid] evid5ce-bas$1 evid5ce-in=m$1 & promis+ be/ practices relat$ to id5tify+1 ref]r+1 & support+ *ildr5 & families at risk ( exp]i5c+ exposure to sub/ance abuse or exp]i5c+ sub/ance use disord]1 includ+ opioid misuse1 includ+-- 7,a7 prev5tion /rategies = ^? at risk ( exp]i5c+ or be+ expos$ to sub/ance abuse1 includ+ misuse ( opioids2 7,b7 :ole-family & multi-g5]ational approa*es2 7,c7 community-bas$ initiatives2 7,d7 ref]ral to1 & implem5tation (1 trauma-in=m$ practices & supports2 & 7,e7 multi-g5]ational practices t assi/ p>5ts1 fo/] p>5ts1 & k9%ip & o!r c>egiv]s 7e7 ,,faca ,! ,f$]al ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app4 #b7 %all n apply to ! ,task ,=ce4 7f7 ,action plan2 reports ,! ,task ,=ce-- 7#a7 %all prep>e a detail$ action plan to be implem5t$ by p>ticipat+ ,f$]al ag5cies to create a collaborative1 coord9at$ response to ! opioid crisis1 :i* %all include-- 7,a7 relevant in=mation id5tifi$ & collect$ "u subsection 7d72 7,b7 a propos$ timel9e = implem5t+ recomm5dations & ef=ts id5tifi$ "u subsection 7d72 & 7,c7 a description ( h[ o!r ,f$]al ag5cies & (fices ) exp]i5ce1 exp]tise1 or in=mation relevant 9 respond+ to ! opioid crisis t h provid$ input "u subsection 7c77#d7 w be p>ticipat+ 9 ! coord9at$ approa*2 7#b7 %all submit to ! ,congress a report describ+ ! action plan prep>$ "u p>agraph 7#a71 includ+1 :]e applicable1 id5tification ( any recomm5dations includ$ 9 su* plan t require additional legislative au?ority to implem5t2 & 7#c7 %all submit a report to ! ,gov]nors describ+ ! opportunities = local- & ,/ate-level p>tn]%ips1 pr(essional developm5t1 or be/ practices recomm5d$ "u subsection 7d77#c74 7g7 ,dissem9ation 7#a7 ,9 g5]al ,! action plan & reports requir$ "u subsection 7f7 %all be-- 7,a7 dissem9at$ widely1 includ+ among ! p>ticipat+ ,f$]al ag5cies & ! ,gov]nors2 & 7,b7 be made publicly available onl9e 9 an accessible =mat4 7#b7 ,deadl9e ,! action plan & reports requir$ "u subsection 7f7 may be releas$ on sep>ate dates b %all be releas$ n lat] ?an #i mon?s aft] ! date ( ! enactm5t ( ?is ,act4 7h7 ,t]m9ation ,! ,task ,=ce %all t]m9ate #cj days aft] ! dissem9ation ( ! action plan & reports "u subsection 7g74 7i7 ,fund+ ,! adm9i/rative exp5ses ( ! ,task ,=ce %all be paid out ( exi/+ ,dep>tm5t ( ,heal? & ,human ,s]vices funds or appropriations4 7j7 ,def9itions ,= purposes ( ?is section3 7#a7 ,! t]m ,gov]nor means ! *ief executive (fic] ( a ,/ate4 7#b7 ,! t]m p>ticipat+ ,f$]al ag5cies means all ! ,executive ag5cies 7z def9$ 9 section #aje ( title #e1 ,unit$ ,/ates ,code7 ^: (ficials h be5 appo9t$ to ! ,task ,=ce4 7#c7 ,! t]m ,/ate means ea* ( ! sev]al ,/ates1 ! ,di/rict ( ,columbia1 ! ,commonweal? ( ,pu]to ,rico1 ! ,virg9 ,isl&s1 ,guam1 ,am]ican ,samoa1 & ! ,commonweal? ( ! ,nor!rn ,m>iana ,isl&s4 ,e ,e/abli%m5t ( an ,advisory ,committee on ,opioids & ! ,workplace #hjda4 ,e/abli%m5t ( an ,advisory ,committee on ,opioids & ! ,workplace 7a7 ,e/abli%m5t ,n lat] ?an #ij days aft] enactm5t ( ?is ,act1 ! ,secret>y ( ,labor %all e/abli% an ,advisory ,committee on ,opioids & ! ,workplace 7ref]r$ to 9 ?is subtitle z ! ,advisory ,committee7 to advise ! ,secret>y on actions ! ,dep>tm5t ( ,labor c take to provide in=mational res\rces & be/ practices on h[ to appropriately address ! impact ( opioid abuse on ! workplace & support work]s abus+ opioids4 7b7 ,memb]%ip 7#a7 ,composition ,! ,secret>y ( ,labor %all appo9t z memb]s ( ! ,advisory ,committee #ai individuals ) exp]tise 9 employm5t1 workplace heal? programs1 human res\rces1 sub/ance use disord]1 & o!r relevant fields4 ,! ,advisory ,committee %all be compos$ z foll[s3 7,a7 ,f\r ( ! memb]s %all be individuals repres5tative ( employ]s or o!r organizations repres5t+ employ]s4 7,b7 ,f\r ( ! memb]s %all be individuals repres5tative ( work]s or o!r organizations repres5t+ work]s1 ( :i* at lea/ two mu/ be repres5tatives designat$ by labor organizations4 7,c7 ,?ree ( ! memb]s %all be individuals repres5tative ( heal? b5efit plans1 employee assi/ance plan provid]s1 work]s' comp5sation program adm9i/rators1 & workplace safety & heal? pr(essionals4 7,d7 ,eight ( ! memb]s %all be individuals repres5tative ( sub/ance abuse treatm5t & recov]y exp]ts1 includ+ m$ical doctors1 lic5s$ addiction !rapi/s1 & sci5tific & academic rese>*]s1 ( :i* "o individual may be a repres5tative ( a local or ,/ate gov]nm5t ag5cy t ov]sees or coord9ates programs t address sub/ance use disord]4 7#b7 ,*air ,f ! memb]s appo9t$ "u p>agraph 7#a71 ! ,secret>y ( ,labor %all appo9t a *airp]son4 7#c7 ,t]ms ,ea* memb] ( ! ,advisory ,committee %all s]ve = a t]m ( #c ye>s4 ,a memb] appo9t$ to fill a vacancy %all be appo9t$ only = ! rema9d] ( su* t]m4 7#d7 ,quorum ,a majority ( memb]s ( ! ,advisory ,committee %all con/itute a quorum & action %all be tak5 only by a majority vote ( ! memb]s4 7#e7 ,vot+ ,! ,advisory ,committee %all e/abli% vot+ proc$ures4 7#f7 ,no comp5sation ,memb]s ( ! ,advisory ,committee %all s]ve )\t comp5sation4 7#g7 ,disclosure ,e memb] ( ! ,advisory ,committee mu/ disclose ! entity1 if applicable1 t he or %e is repres5t+4 7c7 ,duties 7#a7 ,advisem5t 7,a7 ,9 g5]al ,! ,advisory ,committee e/abli%$ "u subsection 7a7 %all advise ! ,secret>y ( ,labor on actions ! ,dep>tm5t ( ,labor c take to provide in=mational res\rces & be/ practices on h[ to appropriately address ! impact ( opioid abuse on ! workplace & support work]s abus+ opioids4 7,b7 ,consid]ations ,9 provid+ su* advice1 ! ,advisory ,committee %all take into acc\nt-- 7i7 evid5ce-bas$ & o!r employ] sub/ance abuse policies & be/ practices reg>d+ opioid use or abuse1 includ+ b5efits provid$ by employee assi/ance programs or o!r employ]-provid$ b5efits1 programs1 or res\rces2 7ii7 ! effect ( opioid use or abuse on ! safety ( ! workplace z well z policies & proc$ures address+ workplace safety & heal?2 7iii7 ! impact ( opioid abuse on productivity & abs5teeism1 & assessm5ts ( model human res\rces policies t support work]s abus+ opioids1 su* z policies t facilitate seek+ & receiv+ treatm5t & return+ to "w2 7iv7 ! ext5t to :i* alt]native pa9 managem5t treatm5ts o!r ?an opioids are or %\ld be cov]$ by employ]-sponsor$ heal? plans2 7v7 ! legal requirem5ts protect+ employee privacy & heal? in=mation 9 ! workplace1 z well z ! legal requirem5ts relat$ to nondiscrim9ation2 7vi7 pot5tial int]actions ( opioid abuse ) o!r sub/ance use disord]s2 7vii7 any additional b5efits or res\rces available to an employee abus+ opioids t promote reta9+ employm5t or re5t]+ ! work=ce2 7viii7 evid5ce-bas$ initiatives t engage employ]s1 employees1 & community lead]s to promote e>ly id5tification ( opioid abuse1 int]v5tion1 treatm5t1 & recov]y2 7ix7 workplace policies reg>d+ opioid abuse t r$uce /igmatization among fell[ employees & managem5t2 & 7x7 ! legal requirem5ts ( ! ,m5tal ,heal? ,p>ity & ,addiction ,equity ,act & o!r laws relat$ to heal? cov]age ( sub/ance abuse & m5tal heal? s]vices & m$ications4 7#b7 ,report ,prior to its t]m9ation z provid$ 9 subsection 7j71 ! ,advisory ,committee %all issue a report to ! ,secret>y ( ,labor & to ! ,committee on ,education & ! ,work=ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate1 detail+ successful programs & policies involv+ workplace res\rces & b5efits1 includ+ recomm5dations or examples ( be/ practices = h[ employ]s c support & respond to employees impact$ by opioid abuse4 7d7 ,meet+s ,! ,advisory ,committee %all meet at lea/ twice a ye> at ! call ( ! *airp]son4 7e7 ,/aff support ,! ,secret>y ( ,labor %all make available /aff necess>y = ! ,advisory ,committee to c>ry out its responsibilities4 7f7 ,f$]al ,advisory ,committee ,act ,! ,f$]al ,advisory ,committee ,act %all apply to ! ,advisory ,committee e/abli%$ "u ?is subtitle4 7g7 ,no appropriat$ funds ,no additional funds are au?oriz$ to be appropriat$ to c>ry out ?is subtitle4 ,exp5ses ( ! ,advisory ,committee %all be paid ) funds o!rwise appropriat$ to ,dep>tm5tal ,managem5t )9 ! ,dep>tm5t ( ,labor4 7h7 ,ex (ficio ,?ree nonvot+ repres5tatives f ag5cies )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices ^: responsibilities include opioid prescrib+ guidel9es1 workplace safety1 & monitor+ ( sub/ance abuse & prev5tion programs %all be appo9t$ by ! ,secret>y ( ,labor & designat$ z ex (ficio memb]s4 7i7 ,ag5da ,! ,secret>y ( ,labor or a repres5tative ( ! ,secret>y %all consult ) ! ,*air 9 e/abli%+ ! ag5da = ,committee meet+s4 7j7 ,t]m9ation ,! ,advisory ,committee e/abli%$ "u ?is subtitle %all t]m9ate #c ye>s aft] ! date ( enactm5t ( ?is ,act4 ,f ,vet]ans ,treatm5t ,c\rt ,improvem5t #hjea4 ,%ort title ,?is subtitle may be cit$ z ! ,vet]ans ,treatm5t ,c\rt ,improvem5t ,act ( #bjah4 #hjeb4 ,hir+ by ,dep>tm5t ( ,vet]ans ,affairs ( additional ,vet]ans ,ju/ice ,outrea* ,speciali/s 7a7 ,hir+ ( additional ,vet]ans ,ju/ice ,outrea* ,speciali/s 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,vet]ans ,affairs %all hire n few] ?an #ej ,vet]ans ,ju/ice ,outrea* ,speciali/s & place ea* su* ,vet]ans ,ju/ice ,outrea* ,speciali/ at an eligible ,dep>tm5t ( ,vet]ans ,affairs m$ical c5t] 9 accordance ) ?is section4 7#b7 ,requirem5ts ,! ,secret>y %all ensure t ea* ,vet]ans ,ju/ice ,outrea* ,speciali/ employ$ "u p>agraph 7#a7-- 7,a7 s]ves1 ei!r exclusively or 9 addition to o!r duties1 z "p ( a ju/ice team 9 a vet]ans treatm5t c\rt or o!r vet]an-focus$ c\rt2 & 7,b7 o!rwise meets ,dep>tm5t hir+ guidel9es = ,vet]ans ,ju/ice ,outrea* ,speciali/s4 7b7 ,eligible ,dep>tm5t ( ,vet]ans ,affairs m$ical c5t]s ,= purposes ( ?is section1 an eligible ,dep>tm5t ( ,vet]ans ,affairs m$ical c5t] is any ,dep>tm5t ( ,vet]ans ,affairs m$ical c5t] t-- 7#a7 complies ) all ,dep>tm5t guidel9es & regulations = placem5t ( a ,vet]ans ,ju/ice ,outrea* ,speciali/2 7#b7 works )9 a local crim9al ju/ice sy/em ) ju/ice-involv$ vet]ans2 7#c7 ma9ta9s an affiliation ) "o or m vet]ans treatm5t c\rts or o!r vet]an-focus$ c\rts2 & 7#d7 ei!r-- 7,a7 r\t9ely provides ,vet]ans ,ju/ice ,outrea* ,speciali/s to s]ve z "p ( a ju/ice team 9 a vet]ans treatm5t c\rt or o!r vet]an-focus$ c\rt2 or 7,b7 e/abli%es a plan t is approv$ by ! ,secret>y to provide ,vet]ans ,ju/ice ,outrea* ,speciali/s employ$ "u subsection 7a77#a7 to s]ve z "p ( a ju/ice team 9 a vet]ans treatm5t c\rt or o!r vet]an-focus$ c\rt4 7c7 ,placem5t priority ,! ,secret>y %all prioritize ! placem5t ( ,vet]ans ,ju/ice ,outrea* ,speciali/s employ$ "u subsection 7a77#a7 at eligible ,dep>tm5t ( ,vet]ans ,affairs m$ical c5t]s t h or int5d to e/abli% an affiliation1 = ! purpose ( c>ry+ out ! ,vet]ans ,ju/ice ,outrea* ,program1 ) a vet]ans treatm5t c\rt1 or o!r vet]an-focus$ c\rt1 t-- 7#a7 0 e/abli%$ on or aft] ! date ( ! enactm5t ( ?is ,act2 or 7#b7 7,a7 0 e/abli%$ be=e ! date ( ! enactm5t ( ?is ,act2 & 7,b7 is n fully /aff$ ) ,vet]ans ,ju/ice ,outrea* ,speciali/s4 7d7 ,reports 7#a7 ,report by ,secret>y ( ,vet]ans ,affairs 7,a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,vet]ans ,affairs %all submit to ,congress a report on ! implem5tation ( ?is section & its effect on ! ,vet]ans ,ju/ice ,outrea* ,program4 7,b7 ,cont5ts ,! report submitt$ "u p>agraph 7#a7 %all include ! foll[+3 7i7 ,! /atus ( ! ef=ts ( ! ,secret>y to hire ,vet]ans ,ju/ice ,outrea* ,speciali/s pursuant to subsection 7a77#a71 includ+ ! total numb] ( ,vet]ans ,ju/ice ,outrea* ,speciali/s hir$ by ! ,secret>y pursuant to su* subsection & ! numb] t ! ,secret>y expects to hire pursuant to su* subsection4 7ii7 ,! total numb] ( ,vet]ans ,ju/ice ,outrea* ,speciali/s assign$ to ea* ,dep>tm5t ( ,vet]ans ,affairs m$ical c5t] t p>ticipates 9 ! ,vet]ans ,ju/ice ,outrea* ,program1 includ+ ! numb] ( ,vet]ans ,ju/ice ,outrea* ,speciali/s hir$ "u subsection 7a77#a7 disaggregat$ by ,dep>tm5t ( ,vet]ans ,affairs m$ical c5t]4 7iii7 ,! total numb] ( eligible ,dep>tm5t ( ,vet]ans ,affairs m$ical c5t]s t s\ght placem5t ( a ,vet]ans ,ju/ice ,outrea* ,speciali/ "u subsection 7a77#a71 h[ _m ,vet]ans ,ju/ice ,outrea* ,speciali/s ea* su* c5t] s\ght1 & h[ _m ( su* m$ical c5t]s receiv$ no placem5t ( a ,vet]ans ,ju/ice ,outrea* ,speciali/ "u subsection 7a77#a74 7iv7 ,= ea* eligible ,dep>tm5t ( ,vet]ans ,affairs m$ical c5t]-- 7,i7 ! numb] ( ju/ice-involv$ vet]ans :o 7 s]v$ or are expect$ to be s]v$ by a ,vet]ans ,ju/ice ,outrea* ,speciali/ hir$ "u subsection 7a77#a72 & 7,,ii7 ! numb] ( ju/ice-involv$ vet]ans :o d n h access to a ,vet]ans ,ju/ice ,outrea* ,speciali/4 7#b7 ,report by ,comptroll] ,g5]al ( ! ,unit$ ,/ates 7,a7 ,9 g5]al ,n lat] ?an #c ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report on ! implem5tation ( ?is section & ! effectiv5ess ( ! ,vet]ans ,ju/ice ,outrea* ,program4 7,b7 ,cont5ts ,! report requir$ by subp>agraph 7,a7 %all include ! foll[+3 7i7 ,an assessm5t ( :e!r ! ,secret>y has fulfill$ ! ,secret>y's obligations "u ?is section4 7ii7 ,! numb] ( vet]ans :o are s]v$ by ,vet]ans ,ju/ice ,outrea* ,speciali/s hir$ "u subsection 7a77#a71 disaggregat$ by demographics 7includ+ dis*>ge /atus74 7iii7 ,an id5tification ( any subgr\ps ( vet]ans :o und]utilize s]vices provid$ "u laws adm9i/]$ by ! ,secret>y1 includ+ an assessm5t ( :e!r ^! vet]ans h access to ,vet]ans ,ju/ice ,outrea* ,speciali/s "u ! ,vet]ans ,ju/ice ,outrea* ,program4 7iv7 ,su* recomm5dations z ! ,comptroll] ,g5]al may h = ! ,secret>y to improve ! effectiv5ess ( ! ,vet]ans ,ju/ice ,outrea* ,program4 7e7 ,def9itions ,9 ?is section3 7#a7 ,ju/ice team ,! t]m ju/ice team means ! gr\p ( individuals1 :i* may include a judge1 c\rt coord9ator1 prosecutor1 public def5d]1 treatm5t provid]1 probation or o!r law en=cem5t (fic]1 program m5tor1 & ,vet]ans ,ju/ice ,outrea* ,speciali/1 :o assi/ ju/ice-involv$ vet]ans 9 a vet]ans treatm5t c\rt or o!r vet]an-focus$ c\rt4 7#b7 ,ju/ice-involv$ vet]an ,! t]m ju/ice-involv$ vet]an means a vet]an ) active1 ongo+1 or rec5t contact ) "s compon5t ( a local crim9al ju/ice sy/em4 7#c7 ,local crim9al ju/ice sy/em ,! t]m local crim9al ju/ice sy/em means law en=cem5t1 jails1 prisons1 & ,f$]al1 ,/ate1 & local c\rts4 7#d7 ,vet]ans ,ju/ice ,outrea* ,program ,! t]m ,vet]ans ,ju/ice ,outrea* ,program means ! program ?r\gh :i* ! ,dep>tm5t ( ,vet]ans ,affairs id5tifies ju/ice-involv$ vet]ans & provides su* vet]ans ) access to ,dep>tm5t s]vices4 7#e7 ,vet]ans ,ju/ice ,outrea* ,speciali/ ,! t]m ,vet]ans ,ju/ice ,outrea* ,speciali/ means an employee ( ! ,dep>tm5t ( ,vet]ans ,affairs :o s]ves z a liaison betwe5 ! ,dep>tm5t & ! local crim9al ju/ice sy/em on behalf ( a ju/ice-involv$ vet]an4 7#f7 ,vet]ans treatm5t c\rt ,! t]m vet]ans treatm5t c\rt means a ,/ate or local c\rt t is p>ticipat+ 9 ! vet]ans treatm5t c\rt program 7z def9$ 9 section #biia7;i77#a7 ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#db ,u4,s4,c4 #cgig;aa7i77#a7774 ,g ,pe] support c\nsel+ program = wom5 vet]ans #hjfa4 ,pe] support c\nsel+ program = wom5 vet]ans 7a7 ,9 g5]al ,section #agbj;,f7j7 ( title #ch1 ,unit$ ,/ates ,code1 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#d7 7,a7 ,z "p ( ! c\nsel+ program "u ?is subsection1 ! ,secret>y %all emphasize appo9t+ pe] support c\nselors = wom5 vet]ans4 ,to ! degree practicable1 ! ,secret>y %all seek to recruit wom5 pe] support c\nselors ) exp]tise 9-- 7i7 female g5d]-specific issues & s]vices2 7ii7 ! provision ( in=mation ab\t s]vices & b5efits provid$ "u laws adm9i/]$ by ! ,secret>y2 or 7iii7 employm5t m5tor+4 7,b7 ,to ! degree practicable1 ! ,secret>y %all emphasize facilitat+ pe] support c\nsel+ = wom5 vet]ans :o are eligible = c\nsel+ & s]vices "u section #agbj;,d ( ?is title1 h po/-traumatic /ress disord] or suff] f ano!r m5tal heal? condition1 are homeless or at risk ( becom+ homeless1 or are o!rwise at increas$ risk ( suicide1 z det]m9$ by ! ,secret>y4 7,c7 ,! ,secret>y %all conduct outrea* to in=m wom5 vet]ans ab\t ! program & ! assi/ance available "u ?is p>agraph4 7,d7 ,9 c>ry+ out ?is p>agraph1 ! ,secret>y %all coord9ate ) su* community organizations1 ,/ate & local gov]nm5ts1 in/itutions ( high] education1 *amb]s ( comm]ce1 local bus9ess organizations1 organizations t provide legal assi/ance1 & o!r organizations z ! ,secret>y consid]s appropriate4 7,e7 ,9 c>ry+ out ?is p>agraph1 ! ,secret>y %all provide adequate tra9+ = pe] support c\nselors1 includ+ tra9+ c>ri$ out "u ! national program ( tra9+ requir$ by section #cjd7;c7 ( ! ,c>egiv]s & ,vet]ans ,omnibus ,heal? ,s]vices ,act ( #bjaj 7#ch ,u4,s4,c4 #agab;,a note74 4 7b7 ,fund+ ,! ,secret>y ( ,vet]ans ,affairs %all c>ry out p>agraph 7#d7 ( section #agbj;,f7j7 ( title #ch1 ,unit$ ,/ates ,code1 z add$ by subsection 7a71 us+ funds o!rwise made available to ! ,secret>y4 ,no additional funds are au?oriz$ to be appropriat$ by reason ( su* p>agraph4 7c7 ,report to ,congress ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,vet]ans ,affairs %all submit to ! ,committees on ,vet]ans' ,affairs ( ! ,s5ate & ,h\se ( ,repres5tatives a report on ! pe] support c\nsel+ program "u section #agbj;,f7j7 ( title #ch1 ,unit$ ,/ates ,code1 z am5d$ by ?is section4 ,su* report %all include-- 7#a7 ! numb] ( pe] support c\nselors 9 ! program2 7#b7 an assessm5t ( ! effectiv5ess ( ! program2 & 7#c7 a description ( ! ov]sight ( ! program4 ,h ,treat+ ,b>ri]s to ,prosp]ity #hjga4 ,%ort title ,?is subtitle may be cit$ z ! ,treat+ ,b>ri]s to ,prosp]ity ,act ( #bjah4 #hjgb4 ,drug abuse mitigation initiative 7a7 ,9 g5]al ,*apt] #ade ( title #dj1 ,unit$ ,/ates ,code1 is am5d$ by ins]t+ aft] section #adeji ! foll[+3 #adeaj4 ,drug abuse mitigation initiative 7a7 ,9 g5]al ,! ,appala*ian ,regional ,commission may provide te*nical assi/ance to1 make grants to1 ent] into contracts )1 or o!rwise provide am\nts to individuals or entities 9 ! ,appala*ian region = projects & activities to address drug abuse1 includ+ opioid abuse1 9 ! region1 includ+ projects & activities-- 7#a7 to facilitate ! %>+ ( be/ practices among ,/ates1 c\nties1 & o!r exp]ts 9 ! region ) respect to r$uc+ su* abuse2 7#b7 to initiate or exp& programs design$ to elim9ate or r$uce ! h>m to ! work=ce & economic gr[? ( ! region t results f su* abuse2 7#c7 to attract & reta9 relevant heal? c>e s]vices1 bus9esses1 & work]s2 & 7#d7 to develop relevant infra/ructure1 includ+ broadb& infra/ructure t supports ! use ( telem$ic9e4 7b7 ,limitation on available am\nts ,( ! co/ ( any activity eligible = a grant "u ?is section-- 7#a7 n m ?an #ej p]c5t may be provid$ f am\nts appropriat$ to c>ry out ?is section2 & 7#b7 not)/&+ p>agraph 7#a7-- 7,a7 9 ! case ( a project to be c>ri$ out 9 a c\nty = :i* a di/ress$ c\nty designation is 9 effect "u section #adebf1 n m ?an #hj p]c5t may be provid$ f am\nts appropriat$ to c>ry out ?is section2 & 7,b7 9 ! case ( a project to be c>ri$ out 9 a c\nty = :i* an at-risk designation is 9 effect "u section #adebf1 n m ?an #gj p]c5t may be provid$ f am\nts appropriat$ to c>ry out ?is section4 7c7 ,s\rces ( assi/ance ,subject to subsection 7b71 a grant provid$ "u ?is section may be provid$ f am\nts made available to c>ry out ?is section 9 comb9ation ) am\nts made available-- 7#a7 "u any o!r ,f$]al program 7subject to ! availability ( subsequ5t appropriations72 or 7#b7 f any o!r s\rce4 7d7 ,f$]al %>e ,not)/&+ any provision ( law limit+ ! ,f$]al %>e "u any o!r ,f$]al program1 am\nts made available to c>ry out ?is section may be us$ to increase t ,f$]al %>e1 z ! ,appala*ian ,regional ,commission det]m9es to be appropriate4 4 7b7 ,cl]ical am5dm5t ,! analysis = *apt] #ade ( title #dj1 ,unit$ ,/ates ,code1 is am5d$ by ins]t+ aft] ! item relat+ to section #adeji ! foll[+3 #adeaj4 ,drug abuse mitigation initiative4 4 ,i ,support+ ,gr&p>5ts ,rais+ ,gr&*ildr5 #hjha4 ,%ort title ,?is subtitle may be cit$ z ! ,support+ ,gr&p>5ts ,rais+ ,gr&*ildr5 ,act4 #hjhb4 ,f9d+s ,congress f9ds ! foll[+3 7#a7 ,m ?an #b1ejj1jjj gr&p>5ts 9 ! ,unit$ ,/ates are ! prim>y c>etak] ( _! gr&*ildr51 & exp]ts report t su* numb]s are increas+ z ! opioid epidemic exp&s4 7#b7 ,betwe5 #bjji & #bjaf1 ! incid5ce ( p>5tal alcohol or o!r drug use z a contribut+ factor = *ildr5's out-(-home placem5t rose f #be4d to #cg4d p]c5t4 7#c7 ,:5 *ildr5 _c rema9 safely ) _! p>5ts1 placem5t ) relatives is pref]r$ ov] placem5t 9 fo/] c>e ) nonrelatives because placem5t ) relatives provides /ability = *ildr5 & helps !m ma9ta9 family connections4 7#d7 ,! numb] ( fo/] *ildr5 plac$ ) a gr&p>5t or o!r relative increas$ f #bd p]c5t 9 #bjjf to #cb p]c5t 9 #bjaf1 accord+ to data f ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 7#e7 ,gr&p>5ts' lives are enhanc$ by c>+ = _! gr&*ildr52 ! ov]:elm+ majority ( gr&p>5ts report exp]i5c+ significant b5efits 9 s]v+ z _! gr&*ildr5's prim>y c>egiv]s4 7#f7 ,provid+ full-"t c>e to _! gr&*ildr5 may decrease gr&p>5ts' ability to address _! own physical & m5tal heal? ne$s & p]sonal well-be+4 7#g7 ,gr&p>5ts w\ld b5efit f bett] coord9ation & dissem9ation ( in=mation & res\rces available to support !m 9 _! c>egiv+ responsibilities4 #hjhc4 ,advisory ,c\ncil ,to ,support ,gr&p>5ts ,rais+ ,gr&*ildr5 7a7 ,e/abli%m5t ,!re is e/abli%$ an ,advisory ,c\ncil to ,support ,gr&p>5ts ,rais+ ,gr&*ildr54 7b7 ,memb]%ip 7#a7 ,9 g5]al ,! ,advisory ,c\ncil %all be compos$ ( ! foll[+ memb]s1 or _! designee3 7,a7 ,! ,secret>y ( ,heal? & ,human ,s]vices4 7,b7 ,! ,secret>y ( ,education4 7,c7 ,! ,adm9i/rator ( ! ,adm9i/ration = ,community ,liv+4 7,d7 ,! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion4 7,e7 ,! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use4 7,f7 ,! ,assi/ant ,secret>y = ! ,adm9i/ration = ,*ildr5 & ,families4 7,g7 ,a gr&p>5t rais+ a gr&*ild4 7,h7 ,an old] relative c>egiv] ( *ildr54 7,i7 ,z appropriate1 ! head ( o!r ,f$]al dep>tm5ts1 or ag5cies1 id5tifi$ by ! ,secret>y ( ,heal? & ,human ,s]vices z hav+ responsibilities1 or adm9i/]+ programs1 relat+ to curr5t issues affect+ gr&p>5ts or o!r old] relatives rais+ *ildr54 7#b7 ,lead ag5cy ,! ,dep>tm5t ( ,heal? & ,human ,s]vices %all be ! lead ag5cy = ! ,advisory ,c\ncil4 7c7 ,duties 7#a7 ,9 g5]al 7,a7 ,in=mation ,! ,advisory ,c\ncil %all id5tify1 promote1 coord9ate1 & dissem9ate to ! public in=mation1 res\rces1 & ! be/ practices available to help gr&p>5ts & o!r old] relatives-- 7i7 meet ! heal?1 educational1 nutritional1 & o!r ne$s ( ! *ildr5 9 _! c>e2 & 7ii7 ma9ta9 _! own physical & m5tal heal? & emotional well-be+4 7,b7 ,opioids ,9 c>ry+ out ! duties describ$ 9 subp>agraph 7,a71 ! ,advisory ,c\ncil %all consid] ! ne$s ( ^? affect$ by ! opioid crisis4 7,c7 ,native ,am]icans ,9 c>ry+ out ! duties describ$ 9 subp>agraph 7,a71 ! ,advisory ,c\ncil %all consid] ! ne$s ( memb]s ( ,native ,am]ican tribes4 7#b7 ,report 7,a7 ,9 g5]al ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,advisory ,c\ncil %all submit a report to-- 7i7 ! appropriate committees2 7ii7 ! ,/ate ag5cies t are responsible = c>ry+ out family c>egiv] programs2 & 7iii7 ! public onl9e 9 an accessible =mat4 7,b7 ,report =mat ,! report %all include-- 7i7 be/ practices1 res\rces1 & o!r useful in=mation = gr&p>5ts & o!r old] relatives rais+ *ildr5 id5tifi$ "u p>agraph 7#a77;,a7 includ+1 if applicable1 any in=mation relat$ to ! ne$s ( *ildr5 :o h be5 impact$ by ! opioid epidemic2 7ii7 an id5tification ( any gaps 9 items "u clause 7i72 & 7iii7 :]e applicable1 id5tification ( any additional ,f$]al legislative au?ority necess>y to implem5t ! activities describ$ 9 clause 7i7 & 7ii74 7#c7 ,foll[-up report ,n lat] ?an #b ye>s aft] ! date on :i* ! report requir$ "u p>agraph 7#b77;,a7 is submitt$1 ! ,advisory ,c\ncil %all submit a foll[-up report t includes ! in=mation id5tifi$ 9 p>agraph 7#b77;,b7 to-- 7,a7 ! appropriate committees2 7,b7 ! ,/ate ag5cies t are responsible = c>ry+ out family c>egiv] programs2 & 7,c7 ! public onl9e 9 an accessible =mat4 7#d7 ,public input 7,a7 ,9 g5]al ,! ,advisory ,c\ncil %all e/abli% a process = public input to in=m ! developm5t (1 & provide updates to1 ! be/ practices1 res\rces1 & o!r in=mation describ$ 9 p>agraph 7#a7 t %all include-- 7i7 outrea* to ,/ates1 local entities1 & organizations t provide in=mation to1 or support =1 gr&p>5ts or o!r old] relatives rais+ *ildr52 & 7ii7 outrea* to gr&p>5ts & o!r old] relatives ) exp]i5ce rais+ *ildr54 7,b7 ,nature ( outrea* ,su* outrea* %all ask individuals to provide input on-- 7i7 in=mation1 res\rces1 & be/ practices available1 includ+ id5tification ( any gaps & unmet ne$s2 & 7ii7 recomm5dations t w\ld help gr&p>5ts & o!r old] relatives bett] meet ! heal?1 educational1 nutritional1 & o!r ne$s ( ! *ildr5 9 _! c>e1 z well z ma9ta9 _! own physical & m5tal heal? & emotional well-be+4 7d7 ,,faca ,! ,advisory ,c\ncil %all be exempt f ! requirem5ts ( ! ,f$]al ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app474 7e7 ,fund+ ,no additional funds are au?oriz$ to be appropriat$ to c>ry out ?is subtitle4 7f7 ,sunset ,! ,advisory ,c\ncil %all t]m9ate on ! date t is #c ye>s aft] ! date ( enactm5t ( ?is ,act4 #hjhd4 ,def9itions ,9 ?is subtitle3 7#a7 ,advisory ,c\ncil ,9 ?is subtitle1 ! t]m ,advisory ,c\ncil means ! ,advisory ,c\ncil to ,support ,gr&p>5ts ,rais+ ,gr&*ildr5 t is e/abli%$ "u section #hjhc4 7#b7 ,appropriate committees ,9 ?is subtitle1 ! t]m appropriate committees means ! foll[+3 7,a7 ,! ,special ,committee on ,ag+ ( ! ,s5ate4 7,b7 ,! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate4 7,c7 ,! ,committee on ,education & ! ,work=ce ( ! ,h\se ( ,repres5tatives4 7,d7 ,! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 ,j ,reau?oriz+ & ,ext5d+ ,grants = ,recov]y f ,opioid ,use ,programs #hjia4 ,%ort title ,?is subtitle may be cit$ z ! ,reau?oriz+ & ,ext5d+ ,grants = ,recov]y f ,opioid ,use ,programs ,act ( #bjah or ! ,,regr\p ,act ( #bjah4 #hjib4 ,reau?orization ( ! compreh5sive opioid abuse grant program ,section #ajja7;a77#bg7 ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#cd ,u4,s4,c4 #ajbfa7;a77#bg77 is am5d$ by /rik+ ?r\gh #bjba & ins]t+ & #bjah1 & #ccj1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc4 ,,ix ,,sitsa ,act #ijja4 ,%ort title ,?is title may be cit$ z ! ,/op ! ,importation & ,traffick+ ( ,syn!tic ,analogues ,act ( #bjag or ! ,,sitsa ,act4 #ijjb4 ,e/abli%m5t ( s*$ule ,a ,section #bjb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hab7 is am5d$-- 7#a7 9 subsection 7a71 by /rik+ five s*$ules ( controll$ sub/ances1 to be kn[n z s*$ules ,i1 ,,ii1 ,,iii1 ,,iv1 & ,v & ins]t+ six s*$ules ( controll$ sub/ances1 to be kn[n z s*$ules ,i1 ,,ii1 ,,iii1 ,,iv1 ,v1 & ,a2 7#b7 9 subsection 7b71 by add+ at ! end ! foll[+3 7#f7 ,s*$ule ,a 7,a7 ,9 g5]al ,! drug or sub/ance-- 7i7 has-- 7,i7 a *emical /ructure t is sub/antially simil> to ! *emical /ructure ( a controll$ sub/ance 9 s*$ule ,i1 ,,ii1 ,,iii1 ,,iv1 or ,v2 & 7,,ii7 an actual or pr$ict$ /imulant1 depressant1 or halluc9og5ic effect on ! c5tral n]v\s sy/em t is sub/antially simil> to or great] ?an ! /imulant1 depressant1 or halluc9og5ic effect on ! c5tral n]v\s sy/em ( a controll$ sub/ance 9 s*$ule ,i1 ,,ii1 ,,iii1 ,,iv1 or ,v2 & 7ii7 is n-- 7,i7 li/$ or o!rwise includ$ 9 any o!r s*$ule 9 ?is section or by regulation ( ! ,attorney ,g5]al2 & 7,,ii7 ) respect to a p>ticul> p]son1 subject to an exemption t is 9 effect = inve/igational use1 = t p]son1 "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 to ! ext5t conduct ) respect to su* sub/ance is pursuant to su* exemption4 7,b7 ,pr$ict$ /imulant1 depressant1 or halluc9og5ic effect ,= purpose ( ?is p>agraph1 a pr$ict$ /imulant1 depressant1 or halluc9og5ic effect on ! c5tral n]v\s sy/em may be bas$ on-- 7i7 ! *emical /ructure &-- 7,i7 ! /ructure activity relation%ips2 or 7,,ii7 b9d+ receptor assays & o!r relevant sci5tific in=mation ab\t ! sub/ance2 7ii7 7,i7 ! curr5t or relative pot5tial = abuse ( ! sub/ance2 & 7,,ii7 ! cl&e/9e importation1 manufacture1 or di/ribution1 or div]sion f legitimate *annels1 ( ! sub/ance2 or 7iii7 ! capacity ( ! sub/ance to cause a /ate ( dep5d5ce1 includ+ physical or psy*ological dep5d5ce t is simil> to or great] ?an t ( a controll$ sub/ance 9 s*$ule ,i1 ,,ii1 ,,iii1 ,,iv1 or ,v4 2 & 7#c7 9 subsection 7c71 9 ! matt] prec$+ s*$ule ,i1 by /rik+ ,,iv1 & ,v & ins]t+ ,,iv1 ,v1 & ,a4 #ijjc4 ,tempor>y & p]man5t s*$ul+ ( s*$ule ,a sub/ances ,section #bja ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #haa7 is am5d$ by add+ at ! end ! foll[+3 7k7 ,tempor>y & p]man5t s*$ul+ ( s*$ule ,a sub/ances 7#a7 ,! ,attorney ,g5]al may issue a tempor>y ord] add+ a drug or sub/ance to s*$ule ,a if ! ,attorney ,g5]al f9ds t-- 7,a7 ! drug or o!r sub/ance satisfies ! crit]ia = be+ consid]$ a s*$ule ,a sub/ance2 & 7,b7 add+ su* drug or sub/ance to s*$ule ,a w assi/ 9 prev5t+ abuse ( ! drug or o!r sub/ance4 7#b7 ,a tempor>y s*$ul+ ord] issu$ "u p>agraph 7#a7 %all n take effect until #cj days aft] ! date ( ! publication by ! ,attorney ,g5]al ( a notice 9 ! ,f$]al ,regi/] ( ! int5tion to issue su* ord] & ! gr\nds ^u :i* su* ord] is to be issu$4 ,! tempor>y s*$ul+ ord] %all expire n lat] ?an #e ye>s aft] ! date x becomes effective1 except t ! ,attorney ,g5]al may1 dur+ ! p5d5cy ( proce$+s "u p>agraph 7#e71 ext5d ! tempor>y s*$ul+ ord] = up to #ahj days4 7#c7 ,a tempor>y s*$ul+ ord] issu$ "u p>agraph 7#a7 %all be vacat$ ^u ! issuance ( a p]man5t ord] issu$ "u p>agraph 7#e7 ) reg>d to ! same sub/ance1 or ^u ! subsequ5t issuance ( any s*$ul+ ord] "u ?is section4 7#d7 ,a tempor>y s*$ul+ ord] issu$ "u p>agraph 7#a7 %all n be subject to judicial review4 7#e7 7,a7 ,beg9n+ no e>li] ?an #c ye>s aft] issu+ an ord] tempor>ily s*$ul+ a drug or o!r sub/ance "u ?is subsection1 ! ,attorney ,g5]al may1 by rule1 issue a p]man5t ord] add+ a drug or o!r sub/ance to s*$ule ,a if su* drug or sub/ance satisfies ! crit]ia = be+ consid]$ a controll$ sub/ance 9 s*$ule ,a "u ?is subsection1 except z provid$ 9 subp>agraph 7,b74 7,b7 ,if ! ,secret>y has det]m9$1 bas$ on relevant sci5tific /udies & necess>y data reque/$ by ! ,secret>y & ga!r$ by ! ,attorney ,g5]al1 t a drug or o!r sub/ance t has be5 tempor>ily plac$ 9 s*$ule ,a does n h suffici5t pot5tial = abuse to w>rant control 9 any s*$ule1 & s advises ! ,attorney ,g5]al 9 writ+1 ! ,attorney ,g5]al may n issue a p]man5t s*$ul+ ord] "u subp>agraph 7,a7 & %all1 )9 #cj days ( receiv+ ! ,secret>y's advice issue an ord] imm$iately t]m9at+ ! tempor>y s*$ul+ ord]4 7#f7 ,be=e initiat+ proce$+s "u p>agraph 7#a71 ! ,attorney ,g5]al %all transmit notice ( a tempor>y ord] propos$ to be issu$ to ! ,secret>y ( ,heal? & ,human ,s]vices4 ,9 issu+ an ord] "u p>agraph 7#a71 ! ,attorney ,g5]al %all take into consid]ation any comm5ts submitt$ by ! ,secret>y ( ,heal? & ,human ,s]vices 9 response to a notice transmitt$ pursuant to ?is p>agraph4 7#g7 ,on ! date ( ! publication ( a notice 9 ! ,f$]al ,regi/] pursuant to p>agraph 7#b71 ! ,attorney ,g5]al %all transmit ! same notice to ,congress4 ,! tempor>y s*$ul+ ord] %all take effect accord+ to p>agraph 7#b71 except t ! tempor>y s*$ul+ ord] may be disapprov$ by an ,act ( ,congress )9 #ahj days f ! date ( publication ( ! notice 9 ! ,f$]al ,regi/]4 4 #ijjd4 ,p5alties 7a7 ,controll$ ,sub/ances ,act ,! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hja et seq47 is am5d$-- 7#a7 9 section #dja7;b77#a7 7#ba ,u4,s4,c4 #hda7;b77#a771 by add+ at ! end ! foll[+3 7,f7 7i7 ,9 ! case ( any controll$ sub/ance 9 s*$ule ,a1 su* p]son %all be s5t5c$ to a t]m ( imprisonm5t ( n m ?an #aj ye>s & if dea? or s]i\s bodily injury results f ! use ( su* sub/ance %all be s5t5c$ to a t]m ( imprisonm5t ( n m ?an #ae ye>s1 a f9e n to exce$ ! great] ( t au?oriz$ 9 accordance ) ! provisions ( title #ah1 ,unit$ ,/ates ,code1 or #ejj1jjj if ! def5dant is an individual or #b4e million if ! def5dant is o!r ?an an individual1 or bo?4 7ii7 ,if any p]son commits su* a violation aft] a prior conviction = a felony drug (f5se has become f9al1 su* p]son %all be s5t5c$ to a t]m ( imprisonm5t ( n m ?an #bj ye>s & if dea? or s]i\s bodily injury results f ! use ( su* sub/ance %all be s5t5c$ to a t]m ( imprisonm5t ( n m ?an #cj ye>s1 a f9e n to exce$ ! great] ( twice t au?oriz$ 9 accordance ) ! provisions ( title #ah1 ,unit$ ,/ates ,code1 or #a million if ! def5dant is an individual or #e million if ! def5dant is o!r ?an an individual1 or bo?4 7iii7 ,any s5t5ce impos+ a t]m ( imprisonm5t "u ?is subp>agraph %all1 9 ! abs5ce ( su* a prior conviction1 impose a t]m ( sup]vis$ release ( n less ?an #b ye>s 9 addition to su* t]m ( imprisonm5t & %all1 if !re 0 su* a prior conviction1 impose a t]m ( sup]vis$ release ( n less ?an #d ye>s 9 addition to su* t]m ( imprisonm5t4 2 7#b7 9 section #djc7;a7 7#ba ,u4,s4,c4 #hdc7;a77-- 7,a7 9 p>agraph 7#h71 by /rik+ or at ! end2 7,b7 9 p>agraph 7#i71 by /rik+ ! p]iod at ! end & ins]t+ 2 or2 & 7,c7 by ins]t+ aft] p>agraph 7#i7 ! foll[+3 7#aj7 to export a sub/ance 9 violation ( ! controll$ sub/ance laws ( ! c\ntry to :i* ! sub/ance is export$4 2 & 7#c7 9 section #djd 7#ba ,u4,s4,c4 #hdd71 by ins]t+ aft] subsection 7a7 ! foll[+3 7b7 ,a p]son %all n be subject to a crim9al or civil p5alty "u ?is title or "u any o!r ,f$]al law solely = possession ( a s*$ule ,a controll$ sub/ance4 4 7b7 ,controll$ ,sub/ances ,import & ,export ,act ,section #ajaj7;b7 ( ! ,controll$ ,sub/ances ,import & ,export ,act 7#ba ,u4,s4,c4 #ifj7;b77 is am5d$ by add+ at ! end ! foll[+3 7#h7 ,9 ! case ( a violation "u subsection 7a7 involv+ a controll$ sub/ance 9 s*$ule ,a1 ! p]son committ+ su* violation %all be s5t5c$ to a t]m ( imprisonm5t ( n m ?an #bj ye>s & if dea? or s]i\s bodily injury results f ! use ( su* sub/ance %all be s5t5c$ to a t]m ( imprisonm5t ( n m ?an life1 a f9e n to exce$ ! great] ( t au?oriz$ 9 accordance ) ! provisions ( title #ah1 ,unit$ ,/ates ,code1 or #a million if ! def5dant is an individual or #e million if ! def5dant is o!r ?an an individual1 or bo?4 ,if any p]son commits su* a violation aft] a prior conviction = a felony drug (f5se has become f9al1 su* p]son %all be s5t5c$ to a t]m ( imprisonm5t ( n m ?an #cj ye>s & if dea? or s]i\s bodily injury results f ! use ( su* sub/ance %all be s5t5c$ to n m ?an life imprisonm5t1 a f9e n to exce$ ! great] ( twice t au?oriz$ 9 accordance ) ! provisions ( title #ah1 ,unit$ ,/ates ,code1 or #b million if ! def5dant is an individual or #aj million if ! def5dant is o!r ?an an individual1 or bo?4 ,not)/&+ section #cehc ( title #ah1 ,unit$ ,/ates ,code1 any s5t5ce impos+ a t]m ( imprisonm5t "u ?is p>agraph %all1 9 ! abs5ce ( su* a prior conviction1 impose a t]m ( sup]vis$ release ( n less ?an #c ye>s 9 addition to su* t]m ( imprisonm5t & %all1 if !re 0 su* a prior conviction1 impose a t]m ( sup]vis$ release ( n less ?an #f ye>s 9 addition to su* t]m ( imprisonm5t4 ,not)/&+ ! prior s5t5ce1 & not)/&+ any o!r provision ( law1 ! c\rt %all n place on probation or susp5d ! s5t5ce ( any p]son s5t5c$ "u ! provisions ( ?is p>agraph :i* provide = a m&atory t]m ( imprisonm5t if dea? or s]i\s bodily injury results4 4 #ijje4 ,false label+ ( s*$ule ,a controll$ sub/ances 7a7 ,9 g5]al ,section #cje ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbe7 is am5d$ by add+ at ! end ! foll[+3 7f7 ,false label+ ( s*$ule ,a controll$ sub/ances 7#a7 ,x %all be unlawful to import1 export1 manufacture1 di/ribute1 disp5se1 or possess ) int5t to manufacture1 di/ribute1 or disp5se1 a s*$ule ,a sub/ance or product conta9+ a s*$ule ,a sub/ance1 unless ! sub/ance or product be>s a label cle>ly id5tify+ a s*$ule ,a sub/ance or product conta9+ a s*$ule ,a sub/ance by ! nom5clature us$ by ! ,int]national ,union ( ,pure & ,appli$ ,*emi/ry 7,,iupac74 7#b7 7,a7 ,a product describ$ 9 subp>agraph 7,b7 is exempt f ! ,int]national ,union ( ,pure & ,appli$ ,*emi/ry nom5clature requirem5t ( ?is subsection if su* product is label$ 9 ! mann] requir$ "u ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 7,b7 ,a product is describ$ 9 ?is subp>agraph if ! product-- 7i7 is ! subject ( an approv$ application z describ$ 9 section #eje7;b7 or 7j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 or 7ii7 is exempt f ! provisions ( section #eje ( su* ,act relat+ to new drugs because-- 7,i7 x is int5d$ solely = inve/igational use z describ$ 9 section #eje7;i7 ( su* ,act2 & 7,,ii7 su* product is be+ us$ exclusively = purposes ( a cl9ical trial t is ! subject ( an effective inve/igational new drug application4 4 7b7 ,p5alties ,section #djb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hdb7 is am5d$-- 7#a7 9 subsection 7a77#af71 by ins]t+ or subsection 7f7 aft] subsection 7e72 & 7#b7 9 subsection 7c77#a77;,d71 by ins]t+ or a s*$ule ,a sub/ance aft] anabolic /]oid4 #ijjf4 ,regi/ration requirem5ts = h&l]s ( s*$ule ,a sub/ances 7a7 ,controll$ ,sub/ances ,act ,section #cjc ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbc7 is am5d$ by add+ at ! end ! foll[+3 7k7 7#a7 ,! ,attorney ,g5]al %all regi/] an applicant to manufacture s*$ule ,a sub/ances if-- 7,a7 ! applicant demon/rates t ! s*$ule ,a sub/ances w be us$ = rese>*1 analytical1 or indu/rial purposes approv$ by ! ,attorney ,g5]al2 & 7,b7 ! ,attorney ,g5]al det]m9es t su* regi/ration is consi/5t ) ! public int]e/ & ) ! ,unit$ ,/ates obligations "u int]national treaties1 conv5tions1 or protocols 9 effect on ! date ( enactm5t ( ?is subsection4 7#b7 ,9 det]m9+ ! public int]e/ "u p>agraph 7#a77;,b71 ! ,attorney ,g5]al %all consid]-- 7,a7 ma9t5ance ( effective controls aga9/ div]sion ( p>ticul> controll$ sub/ances & any controll$ sub/ance 9 s*$ule ,a comp\nd$ !refrom into o!r ?an legitimate m$ical1 sci5tific1 rese>*1 or indu/rial *annels1 by limit+ ! importation & bulk manufacture ( su* controll$ sub/ances to a numb] ( e/abli%m5ts :i* c produce an adequate & un9t]rupt$ supply ( ^! sub/ances "u adequately competitive conditions = legitimate m$ical1 sci5tific1 rese>*1 & indu/rial purposes2 7,b7 compliance ) applicable ,/ate & local law2 7,c7 promotion ( te*nical advances 9 ! art ( manufactur+ sub/ances describ$ 9 subp>agraph 7,a7 & ! developm5t ( new sub/ances2 7,d7 prior conviction record ( applicant "u ,f$]al & ,/ate laws relat+ to ! manufacture1 di/ribution1 or disp5s+ ( sub/ances describ$ 9 p>agraph 7,a72 7,e7 pa/ exp]i5ce 9 ! manufacture ( controll$ sub/ances1 & ! exi/5ce 9 ! e/abli%m5t ( effective control aga9/ div]sion2 & 7,f7 su* o!r factors z may be relevant to & consi/5t ) ! public heal? & safety4 7#c7 ,if an applicant is regi/]$ to manufacture controll$ sub/ances 9 s*$ule ,i or ,,ii "u subsection 7a71 ! applicant %all n be requir$ to apply = a sep>ate regi/ration "u ?is subsection4 7l7 7#a7 ,! ,attorney ,g5]al %all regi/] an applicant to di/ribute s*$ule ,a sub/ances-- 7,a7 if ! applicant demon/rates t ! s*$ule ,a sub/ances w be us$ = rese>*1 analytical1 or indu/rial purposes approv$ by ! ,attorney ,g5]al2 & 7,b7 unless ! ,attorney ,g5]al det]m9es t ! issuance ( su* regi/ration is inconsi/5t ) ! public int]e/4 7#b7 ,9 det]m9+ ! public int]e/ "u p>agraph 7#a77;,b71 ! ,attorney ,g5]al %all consid]-- 7,a7 ma9t5ance ( effective control aga9/ div]sion ( p>ticul> controll$ sub/ances into o!r ?an legitimate m$ical1 sci5tific1 & indu/rial *annels2 7,b7 compliance ) applicable ,/ate & local law2 7,c7 prior conviction record ( applicant "u ,f$]al or ,/ate laws relat+ to ! manufacture1 di/ribution1 or disp5s+ ( sub/ances describ$ 9 subp>agraph 7,a72 7,d7 pa/ exp]i5ce 9 ! di/ribution ( controll$ sub/ances2 & 7,e7 su* o!r factors z may be relevant to & consi/5t ) ! public heal? & safety4 7#c7 ,if an applicant is regi/]$ to di/ribute a controll$ sub/ance 9 s*$ule ,i or ,,ii "u subsection 7b71 ! applicant %all n be requir$ to apply = a sep>ate regi/ration "u ?is subsection4 7m7 7#a7 7,a7 ,n lat] ?an #ij days aft] ! date on :i* a sub/ance is plac$ 9 s*$ule ,a1 any practition] :o 0 engag$ 9 rese>* on ! sub/ance be=e ! placem5t ( ! sub/ance 9 s*$ule ,a & any manufactur] or di/ributor :o 0 h&l+ ! sub/ance be=e ! placem5t ( ! sub/ance 9 s*$ule ,a %all regi/] ) ! ,attorney ,g5]al4 7,b7 7i7 ,if an applicant describ$ 9 subp>agraph 7,a7 is regi/]$ pursuant to subsection 7f7 to conduct rese>* ) a controll$ sub/ance 9 s*$ule ,i or ,,ii on ! date on :i* ano!r sub/ance is plac$ 9 s*$ule ,a1 ! applicant may1 subject to clause 7iii71 conduct rese>* ) t o!r controll$ sub/ance 9 s*$ule ,a :ile ! application = regi/ration pursuant to subp>agraph 7,a7 is p5d+4 7ii7 ,if an applicant describ$ 9 subp>agraph 7,a7 is regi/]$ pursuant to subsection 7f7 z describ$ 9 clause 7i7 to conduct rese>* ) a controll$ sub/ance 9 s*$ule ,,iii1 ,,iv1 or ,v on ! date on :i* ano!r sub/ance is plac$ 9 s*$ule ,a1 ! applicant may1 subject to clause 7iii71 conduct rese>* ) t o!r controll$ sub/ance 9 s*$ule ,a :ile ! application = regi/ration pursuant to subp>agraph 7,a7 is p5d+1 provid$ ! sub/ance = :i* ! applicant is regi/]$ to conduct rese>* is 9 ! same s*$ule z1 or a less-re/rict$ s*$ule ?an1 ! controll$ sub/ance ^: simil>ity 9 *emical /ructure & actual or pr$ict$ effect to ! controll$ sub/ance 9 s*$ule ,a =m$ ! basis = placem5t ( ! sub/ance 9 s*$ule ,a1 z set =? 9 ! ord] publi%$ 9 ! ,f$]al ,regi/] plac+ ! sub/ance 9 s*$ule ,a4 7iii7 ,! p]mission to conduct rese>* pursuant to clause 7i7 or clause 7ii7 is conditional on ! applicant's comply+ ) ! regi/ration & o!r requirem5ts = controll$ sub/ances 9 s*$ule ,a4 7iv7 ,?is subp>agraph does n apply to applicants regi/]$ pursuant to subsection 7f7 ^: au?orization to conduct rese>* ) any controll$ sub/ances is limit$ to do+ s z a co9cid5t activity pursuant to applicable regulations ( ! ,attorney ,g5]al4 7#b7 7,a7 ,n lat] ?an #fj days aft] ! date on :i* ! ,attorney ,g5]al receives an application = regi/ration to conduct rese>* on a s*$ule ,a sub/ance1 ! ,attorney ,g5]al %all-- 7i7 grant1 or initiate proce$+s "u section #cjd7;c7 to d5y1 ! application2 or 7ii7 reque/ supplem5tal in=mation f ! applicant4 7,b7 ,n lat] ?an #cj days aft] ! date on :i* ! ,attorney ,g5]al receives supplem5tal in=mation reque/$ "u subp>agraph 7,a77ii7 9 connection ) an application describ$ 9 subp>agraph 7,a71 ! ,attorney ,g5]al %all grant or d5y ! application4 7n7 7#a7 ,! ,attorney ,g5]al %all regi/] a sci5tific inve/igator or a qualifi$ rese>* in/itution to conduct rese>* ) controll$ sub/ances 9 s*$ule ,a 9 accordance ) ?is subsection4 ,9 evaluat+ applications = su* regi/ration1 ! ,attorney ,g5]al %all apply ! crit]ia set =? 9 subsection 7f7 ( ?is section t apply to practition]s seek+ a regi/ration to conduct rese>* ) a s*$ule ,i controll$ sub/ance1 except t ! applicant %all n be requir$ to submit a rese>* protocol4 7#b7 ,if ! applicant is n curr5tly regi/]$ "u subsection 7f7 to conduct rese>* ) a s*$ule ,i controll$ sub/ance1 ! ,attorney ,g5]al %all ref] ! application to ! ,secret>y1 :o %all det]m9e :e!r ! applicant w be engag$ 9 bona fide rese>* & is qualifi$ to conduct su* rese>*4 ,! #fj-;day p]iod "u subsection 7m77#b77;,a7 %all be toll$ dur+ ! p]iod beg9n+ on ! date on :i* ! ,attorney ,g5]al ref]s an application to ! ,secret>y "u ?is p>agraph1 & end+ on ! date on :i* ! ,secret>y submits a det]m9ation relat$ to su* ref]ral to ! ,attorney ,g5]al4 7#c7 ,an applicant :o meets ! crit]ia "u subsection 7m77#a77;,b7 ) respect to a p>ticul> s*$ule ,a controll$ sub/ance %all be consid]$ qualifi$ to conduct rese>* ) t sub/ance4 ,! ,attorney ,g5]al %all modify su* applicant's regi/ration to include su* s*$ule ,a controll$ sub/ance 9 accordance ) ?is p>agraph4 ,! applicant %all notify ! ,attorney ,g5]al ( 8 int5t to conduct rese>* ) a controll$ sub/ance 9 s*$ule ,a4 ,^u receiv+ su* notification1 ! ,attorney ,g5]al %all modify ! practition]'s exi/+ regi/ration to au?orize rese>* ) s*$ule ,a controll$ sub/ances1 unless ! ,attorney ,g5]al det]m9es t ! regi/ration modification w\ld be inconsi/5t ) ! public int]e/ bas$ on ! crit]ia ( subsection 7f74 7#d7 ,regi/rations issu$ "u ?is subsection to a qualifi$ rese>* in/itution w apply to all ag5ts & employees ( t in/itution act+ )9 ! scope ( _! pr(essional practice4 7#e7 ,at lea/ #cj days prior to conduct+ any rese>* ) a controll$ sub/ance 9 s*$ule ,a1 ! regi/rant %all provide ! ,attorney ,g5]al ) writt5 notification ( ! foll[+3 7,a7 ,! "n ( & drug code = ea* sub/ance4 7,b7 ,! "n ( ea* individual ) access to ea* sub/ance4 7,c7 ,! am\nt ( ea* sub/ance4 7,d7 ,o!r simil> in=mation ! ,attorney ,g5]al may require4 7#f7 ,! quantity ( a s*$ule ,a controll$ sub/ance possess$ by a p]son regi/]$ "u ?is subsection %all be appropriate = ! rese>* be+ conduct$1 subject to ! additional limitations set =? 9 ?is p>agraph4 ,to r$uce ! risk ( div]sion1 ! ,attorney ,g5]al may e/abli% limitations on ! quantity ( s*$ule ,a controll$ sub/ances t may be manufactur$ or possess$ = purposes ( rese>* "u ?is subsection & %all publi% su* limitations on ! website ( ! ,drug ,en=cem5t ,adm9i/ration4 ,a p]son regi/]$ "u ?is subsection may1 bas$ on legitimate rese>* ne$s1 apply to ! ,attorney ,g5]al to manufacture or possess an am\nt great] ?an t s specifi$ by ! ,attorney ,g5]al4 ,! ,attorney ,g5]al %all specify ! mann] 9 :i* su* applications %all be submitt$4 ,! ,attorney ,g5]al %all act on an application fil$ "u ?is subp>agraph )9 #cj days ( receipt ( su* application4 ,if ! ,attorney ,g5]al fails to act )9 #cj days1 ! regi/rant %all be all[$ to manufacture & possess up to ! am\nt reque/$4 ,! ,attorney ,g5]al %all h ! au?ority to rev]se ! increase = cause4 7#g7 ,! ,attorney ,g5]al %all by regulation specify ! mann] 9 :i* applications = regi/ration "u ?is subsection %all be submitt$4 7#h7 ,regi/rants au?oriz$ "u ?is subsection may manufacture & possess s*$ule ,a controll$ sub/ances up to ! approv$ am\nts only = use 9 _! own rese>* sett+ or in/itution4 ,manufactur+ = use 9 any o!r sett+ or in/itution %all require a manufactur]'s regi/ration "u section #cjc7;a74 4 7b7 ,controll$ ,sub/ances ,import & ,export ,act ,section #ajjh ( ! ,controll$ ,sub/ances ,import & ,export ,act 7#ba ,u4,s4,c4 #ieh7 is am5d$ by add+ at ! end ! foll[+3 7j7 7#a7 ,! ,attorney ,g5]al %all regi/] an applicant to import or export a s*$ule ,a sub/ance if-- 7,a7 ! applicant demon/rates t ! s*$ule ,a sub/ances w be us$ = rese>*1 analytical1 or indu/rial purposes approv$ by ! ,attorney ,g5]al2 & 7,b7 ! ,attorney ,g5]al det]m9es t su* regi/ration is consi/5t ) ! public int]e/ & ) ! ,unit$ ,/ates obligations "u int]national treaties1 conv5tions1 or protocols 9 effect on ! date ( enactm5t ( ?is subsection4 7#b7 ,9 det]m9+ ! public int]e/ "u p>agraph 7#a77;,b71 ! ,attorney ,g5]al %all consid] ! factors describ$ 9 subp>agraphs 7,a7 ?r\gh 7,f7 ( section #cjc7k77#b74 7#c7 ,if an applicant is regi/]$ to import or export a controll$ sub/ance 9 s*$ule ,i or ,,ii "u subsection 7a71 ! applicant %all n be requir$ to apply = a sep>ate regi/ration "u ?is subsection4 4 #ijjg4 ,additional con=m+ am5dm5ts 7a7 ,controll$ ,sub/ances ,act ,! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hja et seq47 is am5d$-- 7#a7 9 section #cjc7;c7 7#ba ,u4,s4,c4 #hbc7;c77-- 7,a7 by /rik+ subsections 7a7 & 7b7 & ins]t+ subsection 7a71 7b71 7k71 or 7l72 & 7,b7 by /rik+ s*$ule ,i or ,,ii & ins]t+ s*$ule ,i1 ,,ii1 or ,a2 7#b7 9 section #cjf 7#ba ,u4,s4,c4 #hbf7-- 7,a7 9 subsection 7a71 9 ! fir/ s5t5ce1 by /rik+ s*$ules ,i & ,,ii & ins]t+ s*$ules ,i1 ,,ii1 & ,a2 7,b7 9 subsection 7b71 9 ! second s5t5ce1 by /rik+ s*$ule ,i or ,,ii & ins]t+ s*$ule ,i1 ,,ii1 or ,a2 7,c7 9 subsection 7c71 9 ! fir/ s5t5ce1 by /rik+ s*$ules ,i & ,,ii & ins]t+ s*$ules ,i1 ,,ii1 & ,a2 7,d7 9 subsection 7d71 9 ! fir/ s5t5ce1 by /rik+ s*$ule ,i or ,,ii & ins]t+ s*$ule ,i1 ,,ii1 or ,a2 7,e7 9 subsection 7e71 9 ! fir/ s5t5ce1 by /rik+ s*$ule ,i or ,,ii & ins]t+ s*$ule ,i1 ,,ii1 or ,a2 & 7,f7 9 subsection 7f71 9 ! fir/ s5t5ce1 by /rik+ s*$ules ,i & ,,ii & ins]t+ s*$ules ,i1 ,,ii1 & ,a2 7#c7 9 section #cjh7;a7 7#ba ,u4,s4,c4 #hbh7;a771 by /rik+ s*$ule ,i or ,,ii & ins]t+ s*$ule ,i1 ,,ii1 or ,a2 7#d7 9 section #djb7;b7 7#ba ,u4,s4,c4 #hdb7;b771 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ s*$ule ,i or ,,ii & ins]t+ s*$ule ,i1 ,,ii1 or ,a2 7#e7 9 section #djc7;a77#a7 7#ba ,u4,s4,c4 #hdc7;a77#a771 by /rik+ s*$ule ,i or ,,ii & ins]t+ s*$ule ,i1 ,,ii1 or ,a2 & 7#f7 9 section #eaa7;f7 7#ba ,u4,s4,c4 #hha7;f771 by /rik+ s*$ule ,i or ,,ii ea* place x appe>s & ins]t+ s*$ule ,i1 ,,ii1 or ,a4 7b7 ,controll$ ,sub/ances ,import ,export ,act ,! ,controll$ ,sub/ances ,import & ,export ,act 7#ba ,u4,s4,c4 #iea et seq47 is am5d$-- 7#a7 9 section #ajjb7;a7 7#ba ,u4,s4,c4 #ieb7;a77-- 7,a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ s*$ule ,i or ,,ii & ins]t+ s*$ule ,i1 ,,ii1 or ,a2 & 7,b7 9 p>agraph 7#b71 by /rik+ s*$ule ,i or ,,ii & ins]t+ s*$ule ,i1 ,,ii1 or ,a2 7#b7 9 section #ajjc 7#ba ,u4,s4,c4 #iec7-- 7,a7 9 subsection 7c71 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ s*$ule ,i or ,,ii & ins]t+ s*$ule ,i1 ,,ii1 or ,a2 & 7,b7 9 subsection 7d71 by /rik+ s*$ule ,i or ,,ii & ins]t+ s*$ule ,i1 ,,ii1 or ,a2 7#c7 9 section #ajjd7a7 7#ba ,u4,s4,c4 #ied7a771 by /rik+ s*$ule ,i & ins]t+ s*$ule ,i or ,a2 7#d7 9 section #ajje 7#ba ,u4,s4,c4 #iee71 by /rik+ s*$ule ,i or ,,ii & ins]t+ s*$ule ,i1 ,,ii1 or ,a2 & 7#e7 9 section #ajji7;a7 7#ba ,u4,s4,c4 #iei7;a771 by /rik+ s*$ule ,i or ,,ii & ins]t+ s*$ule ,i1 ,,ii1 or ,a4 #ijjh4 ,controll$ sub/ance analogues ,section #ajb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hjb7 is am5d$-- 7#a7 9 p>agraph 7#f71 by /rik+ or ,v & ins]t+ ,v1 or ,a2 7#b7 9 p>agraph 7#ad7-- 7,a7 by /rik+ s*$ule ,i7c7 & & ins]t+ s*$ule ,i7c71 s*$ule ,a1 &2 & 7,b7 by /rik+ s*$ule ,i7c71 & ins]t+ s*$ule ,i7c7 & s*$ule ,a12 & 7#c7 9 p>agraph 7#cb77;,a71 by /rik+ 7#cb77;,a7 & all t foll[s ?r\gh clause 7iii7 & ins]t+ ! foll[+3 7#cb7 7,a7 ,except z provid$ 9 subp>agraph 7,c71 ! t]m controll$ sub/ance analogue means a sub/ance ^: *emical /ructure is sub/antially simil> to ! *emical /ructure ( a controll$ sub/ance 9 s*$ule ,i or ,,ii-- 7i7 :i* has a /imulant1 depressant1 or halluc9og5ic effect on ! c5tral n]v\s sy/em t is sub/antially simil> to or great] ?an ! /imulant1 depressant1 or halluc9og5ic effect on ! c5tral n]v\s sy/em ( a controll$ sub/ance 9 s*$ule ,i or ,,ii2 or 7ii7 ) respect to a p>ticul> p]son1 :i* su* p]son repres5ts or int5ds to h a /imulant1 depressant1 or halluc9og5ic effect on ! c5tral n]v\s sy/em t is sub/antially simil> to or great] ?an ! /imulant1 depressant1 or halluc9og5ic effect on ! c5tral n]v\s sy/em ( a controll$ sub/ance 9 s*$ule ,i or ,,ii4 4 #ijji4 ,rules ( con/ruction ,no?+ 9 ?is title1 or ! am5dm5ts made by ?is title1 may be con/ru$ to limit-- 7#a7 ! prosecution ( (f5ses involv+ controll$ sub/ance analogues "u ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hja et seq472 or 7#b7 ! au?ority ( ! ,attorney ,g5]al to tempor>ily or p]man5tly s*$ule1 res*$ule1 or decontrol controll$ sub/ances "u provisions ( section #bja ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #haa7 t are 9 effect on ! day be=e ! date ( enactm5t ( ?is title4 #ijaj4 ,/udy by ,comptroll] ,g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is title1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all complete a /udy & submit a report to ! ,committees on ! ,judici>y ( ! ,h\se ( ,repres5tatives & ( ! ,s5ate reg>d+ ! co/s associat$ ) ! am5dm5ts made by section #d1 includ+-- 7#a7 ! annual am\nts exp5d$ by ,f$]al ag5cies 9 c>ry+ out ! am5dm5ts2 7#b7 ! co/s associat$ ) arre/s1 trials1 convictions1 imprisonm5t1 or imposition ( o!r sanctions 9 accordance ) ! am5dm5ts2 & 7#c7 ! impact 7includ+ ! fiscal impact7 ( ! am5dm5ts on exi/+ correctional facilities & ! likelihood t ^? am5dm5ts w create a ne$ = additional capacity = h\s+ prison]s4 #ijaa4 ,report on controll$ sub/ance analogues sold by means ( ! ,int]net ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is title1 & annually !reaft]1 ! ,adm9i/rator ( ! ,drug ,en=cem5t ,adm9i/ration %all make publicly available on ! website ( ! ,drug ,en=cem5t ,adm9i/ration a report on1 = ! previ\s ye>1 ! lawful & unlawful sale ( controll$ sub/ance analogues 7z def9$ 9 section #ajb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hjb77 by means ( ! ,int]net1 includ+ ! foll[+ in=mation3 7#a7 ,! types ( controll$ sub/ance analogues t 7 sold1 & ! numb] ( sales = ea* su* sub/ance4 7#b7 ,! "n ( ea* p]son1 entity1 or ,int]net site1 :e!r 9 ! ,unit$ ,/ates or abroad1 t kn[+ly or int5tionally deliv]s1 di/ributes1 or disp5ses1 or (f]s or attempts to deliv]1 di/ribute1 or disp5se1 a controll$ sub/ance analogue by means ( ! ,int]net1 :e!r lawfully or unlawfully4 7#c7 ,an e/imate ( ! total rev5ue = all ( ! v5dors describ$ 9 p>agraph 7#b7 = all ( ! sales describ$ 9 p>agraph 7#a74 #ijab4 ,controll$ sub/ance analogues ,section #bjc ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hac7 is am5d$-- 7#a7 by /rik+ ,a controll$ & ins]t+ 7a7 ,9 g5]al4--,a controll$2 & 7#b7 by add+ at ! end ! foll[+3 7b7 ,det]m9ation ,9 det]m9+ :e!r a controll$ sub/ance analogue 0 int5d$ = human consumption "u subsection 7a71 ! foll[+ factors may be consid]$1 along ) any o!r relevant factors3 7#a7 ,! m>ket+1 adv]tis+1 & label+ ( ! sub/ance4 7#b7 ,! kn[n efficacy or usefulness ( ! sub/ance = ! m>ket$1 adv]tis$ or label$ purpose4 7#c7 ,! diff]5ce betwe5 ! price at :i* ! sub/ance is sold & ! price at :i* ! sub/ance x is purport$ to be or adv]tis$ z is normally sold4 7#d7 ,! div]sion ( ! sub/ance f legitimate *annels & ! cl&e/9e importation1 manufacture1 or di/ribution ( ! sub/ance4 7#e7 ,:e!r ! def5dant knew or %\ld h kn[n ! sub/ance 0 int5d$ to be consum$ by injection1 inhalation1 +e/ion1 or any o!r imm$iate means4 7#f7 ,any controll$ sub/ance analogue t is manufactur$1 =mulat$1 sold1 di/ribut$1 or m>ket$ ) ! int5t to avoid ! provisions ( exi/+ drug laws4 7c7 ,limitation ,= purposes ( ?is section1 evid5ce t a sub/ance 0 n m>ket$1 adv]tis$1 or label$ = human consumption1 by itself1 %all n be suffici5t to e/abli% t ! sub/ance 0 n int5d$ = human consumption4 4 ,x ,,?rive ,act #ajjja4 ,%ort title ,?is title may be cit$ z ! ,transitional ,h\s+ = ,recov]y 9 ,viable ,environm5ts ,demon/ration ,program ,act or ! ,,?rive ,act4 #ajjjb4 ,demon/ration program to /udy ! impact ( us+ r5tal v\*]s = supportive h\s+ = individuals recov]+ f opioid use disord]s or o!r sub/ance use disord]s ,section #h7o7 ( ! ,unit$ ,/ates ,h\s+ ,act ( #aicg 7#db ,u4,s4,c4 #adcg;f7o77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#ba7 ,r5tal ,v\*] ,demon/ration ,program = supportive h\s+ = individuals recov]+ f opioid use disord]s or o!r sub/ance use disord]s 7,a7 ,e/abli%m5t ,! ,secret>y %all e/abli% a demon/ration program "u :i* ! ,secret>y %all set aside1 allocate1 & di/ribute directly to eligible entities1 f am\nts made available = r5tal assi/ance "u ?is subsection1 ! am\nts specifi$ 9 subp>agraph 7,b7 = an eligible entity to provide a v\*] = su* assi/ance to a cov]$ individual ?r\gh a supportive h\s+ program t provides treatm5t = opioid use disord]s or o!r sub/ance use disord]s 7z applicable71 coord9ation ) work=ce developm5t provid]s1 & su* assi/ance1 z det]m9$ by ! entity4 7,b7 ,am\nt ,! am\nt specifi$ 9 ?is subp>agraph is1 = fiscal ye> #bjai1 ! am\nt necess>y to provide ! less] (-- 7i7 #j4e p]c5t ( ! total numb] ( v\*]s r5ew$ "u ?is subsection dur+ ! fiscal ye> end+ imm$iately be=e ! date ( ! enactm5t ( ?is p>agraph2 or 7ii7 #aj1jjj v\*]s4 7,c7 ,crit]ia = eligible entities ,an eligible entity %all-- 7i7 provide an evid5ce-bas$ treatm5t program & demon/rate ! ability to coord9ate ) work=ce developm5t provid]s = individuals recov]+ f an opioid use disord] or o!r sub/ance use disord]1 z applicable1 t meet /&>ds e/abli%$ by ! ,secret>y2 & 7ii7 demon/rate prior exp]i5ce adm9i/]+ r5tal assi/ance v\*]s1 demon/rate prior exp]i5ce adm9i/]+ supportive h\s+ programs "u ! ,mc,kinney-,v5to ,homeless ,act1 or demon/rate a p>tn]%ip ) a public h\s+ ag5cy or a h\s+ program ( a ,/ate1 unit ( local gov]nm5t1 or ,indian tribe 7z su* t]m is def9$ 9 section #d ( ! ,native ,am]ican ,h\s+ & ,self-,det]m9ation ,act ( #aiif 7#be ,u4,s4,c4 #dajc77 t ensures effective adm9i/ration ( r5tal assi/ance v\*]s4 7,d7 ,application ,to receive a r5tal assi/ance v\*] "u ?is p>agraph1 an eligible entity %all submit an application to ! ,secret>y t %all include-- 7i7 a description ( ! t]ms ( treatm5t program1 coord9ation ) work=ce developm5t provid]s1 & r5tal assi/ance to be provid$ to a cov]$ individual1 & assurances t su* description %all be communicat$ to cov]$ individuals t receive v\*]s pursuant to ! demon/ration program e/abli%$ "u ?is p>agraph2 7ii7 a transitional plan t beg9s on ! date on :i* a cov]$ individual completes ! treatm5t program ( ! eligible entity t includes in=mation on additional treatm5t1 coord9ation ) work=ce developm5t opportunities1 & h\s+ res\rces & s]vices available to su* cov]$ individual2 & 7iii7 evid5ce suffici5t to demon/rate t ! local gov]nm5t hav+ jurisdiction ov] ! location ( any supportive h\s+ facility to be us$ by ! eligible entity 9 connection ) ! demon/ration program "u ?is p>agraph p]mits su* facilities 9 su* location4 7,e7 ,selection ,9 select+ eligible entities to receive r5tal assi/ance v\*]s "u ?is p>agraph1 ! ,secret>y %all-- 7i7 ensure t su* eligible entities-- 7,i7 are div]se2 7,,ii7 repres5t an appropriate balance ( eligible entities locat$ 9 urban & rural areas1 includ+ tribal communities2 7,,iii7 h adequate res\rces = treatm5t1 recov]y1 & supportive s]vices2 7,,iv7 fully comply ) ! ,fair ,h\s+ ,act 7#db ,u4,s4,c4 #cfja et seq47 & ! ,civil ,rights ,act ( #aifd 7#db ,u4,s4,c4 #bjjj;a et seq472 7,v7 appropriately reflect ! impact t opioids are hav+ 9 tribal communities2 & 7,,vi7 provide supportive & transitional h\s+ programs 9 div]se geographic regions ) high rates ( mortality due to opioid use disord]s or o!r sub/ance use disord]s1 z applicable1 bas$ on data ( ! ,c5t]s = ,disease ,control & ,prev5tion2 & 7ii7 consid]1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices & ! ,secret>y ( ,labor-- 7,i7 ! success ( ea* recipi5t eligible entity at help+ individuals complete ! treatm5t program ( ! eligible entity & refra9 f illicit opioid or o!r sub/ance usage1 z applicable2 7,,ii7 ! coord9ation ) work=ce developm5t provid]s by ! eligible entity2 7,,iii7 ! p]c5tage ( p>ticipants 9 unsubsidiz$ employm5t dur+ ! second & f\r? cal5d> qu>t] aft] exit f ! program2 & 7,,iv7 ! p]c5tage ( p>ticipants 9 ! treatm5t program ( ! eligible entity t d n relapse into opioid or o!r sub/ance usage1 z applicable4 7,f7 ,reissuance ( v\*] ,^u t]m9ation ( ! provision ( r5tal assi/ance ?r\gh a v\*] to a cov]$ individual1 ! eligible entity t initially (f]$ su* v\*] may use su* v\*] to provide r5tal assi/ance to ano!r cov]$ individual4 7,g7 ,duration ,! ,secret>y %all n make r5tal assi/ance available "u ?is p>agraph aft] ! expiration ( ! #e-ye> p]iod beg9n+ on ! date ( ! enactm5t ( ?is p>agraph4 7,h7 ,waiv]s ,! ,secret>y may1 ?r\gh publication ( a notice 9 ! ,f$]al ,regi/]1 waive or specify alt]native requirem5ts = any provision ( /atue or regulation gov]n+ ! use ( v\*]s "u ?is subsection 7except = requirem5ts relat+ to fair h\s+1 nondiscrim9ation1 labor /&>ds1 or ! environm5t7 ^u a f9d+ by ! ,secret>y t su* waiv] or alt]native requirem5t is necess>y = ! purposes ( ?is p>agraph4 7,i7 ,reports 7i7 ,by ! eligible entity ,an eligible entity t receives a r5tal assi/ance v\*] "u ?is p>agraph %all submit to ! ,secret>y-- 7,i7 annually1 ! transitional plan describ$ 9 subp>agraph 7,d77ii7 & in=mation on ea* cov]$ individual's h\s+ ^u t]m9ation ( ! provision ( r5tal assi/ance ?r\gh a v\*] to su* cov]$ individual 9 a mann] t protects ! privacy ( su* cov]$ individual2 & 7,,ii7 n lat] ?an #d ye>s aft] ! date ( ! enactm5t ( ?is p>agraph1 a plan describ+ ! treatm5t & h\s+ options = any cov]$ individual assi/$ by su* v\*] :o w n h complet$ ! program be=e ! day t is #e ye>s aft] su* date ( enactm5t4 7ii7 ,by ! ,secret>y ,! ,secret>y %all submit to ,congress a report t analyzes ! impact ( r5tal assi/ance provid$ "u ?is p>agraph-- 7,i7 n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is p>agraph2 & 7,,ii7 n lat] ?an #d ye>s aft] ! date ( ! enactm5t ( ?is p>agraph4 7,j7 ,def9itions ,9 ?is p>agraph3 7i7 ,eligible entity ,! t]m eligible entity means a tribally designat$ h\s+ entity 7z su* t]m is def9$ 9 section #d ( ! ,native ,am]ican ,h\s+ & ,self-,det]m9ation ,act ( #aiif 7#bd ,u4,s4,c4 #dajc771 or a nonpr(it organization1 t meets ! crit]ia describ$ "u subp>agraph 7,c74 7ii7 ,cov]$ individual ,! t]m cov]$ individual means an individual recov]+ f an opioid use disord] or o!r sub/ance use disord]4 4 #ajjjc4 ,repeal ( ,r5tal ,v\*] ,demon/ration ,program ,effective ! day t is #e ye>s aft] ! date ( ! enactm5t ( ?is title1 p>agraph 7#ba7 ( section #h7o7 ( ! ,unit$ ,/ates ,h\s+ ,act ( #aicg 7#db ,u4,s4,c4 #adcg;f7o771 z add$ by ?is title1 is repeal$4 #ajjjd4 ,demon/ration ,close-,out ,an eligible entity t provid$ v\*]s = r5tal assi/ance "u p>agraph 7#ba7 ( section #h7o7 ( ! ,unit$ ,/ates ,h\s+ ,act ( #aicg 7#db ,u4,s4,c4 #adcg;f7o771 z add$ by ?is title1 %all return any su* v\*]s to ! ,secret>y ( ,h\s+ & ,urban ,developm5t n lat] ?an ! day t is #e ye>s aft] ! date ( ! enactm5t ( ?is title = use only = r5ewals ( expir+ contracts = su* assi/ance4 #ajjje4 ,no additional funds au?oriz$ ,no additional funds are au?oriz$ to be appropriat$ to c>ry out ! requirem5ts ( ?is title & ! am5dm5ts made by ?is title4 ,su* requirem5ts %all be c>ri$ out us+ am\nts o!rwise au?oriz$ to be appropriat$4 ,,xi ,,imd ,,c>e ,act #aajja4 ,%ort title ,?is title may be cit$ z ! ,individuals 9 ,m$icaid ,des]ve ,c>e t is ,appropriate & ,responsible 9 its ,execution ,act or ! ,,imd ,,c>e ,act4 #aajjb4 ,m$icaid ,/ate plan option to provide s]vices = c]ta9 individuals ) t>get$ ,s,u,ds 9 in/itutions = m5tal diseases ,section #aiae ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifn7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7l7 ,/ate plan option ,to provide s]vices = c]ta9 individuals 9 in/itutions = m5tal diseases 7#a7 ,9 g5]al ,) respect to cal5d> qu>t]s beg9n+ dur+ ! p]iod beg9n+ ,janu>y #a1 #bjai1 & end+ ,decemb] #ca1 #bjbc1 a ,/ate may elect1 ?r\gh a ,/ate plan am5dm5t1 to1 not)/&+ section #aije7;a71 provide m$ical assi/ance = s]vices furni%$ 9 in/itutions = m5tal diseases & = o!r m$ically necess>y s]vices furni%$ to eligible individuals ) t>get$ ,s,u,ds1 9 accordance ) ! requirem5ts ( ?is subsection4 7#b7 ,paym5ts 7,a7 ,9 g5]al ,am\nts exp5d$ "u a ,/ate plan am5dm5t "u p>agraph 7#a7 = s]vices describ$ 9 su* p>agraph furni%$1 ) respect to a #ab-mon? p]iod1 to an eligible individual ) a t>get$ ,,sud :o is a pati5t 9 an in/itution = m5tal diseases %all be treat$ z m$ical assi/ance = :i* paym5t is made "u section #aijc7;a7 b only to ! ext5t t su* s]vices are furni%$ = n m ?an a p]iod ( #cj days 7:e!r or n consecutive7 dur+ su* #ab-mon? p]iod4 7,b7 ,cl>ification ,paym5t made "u ?is p>agraph = exp5ditures "u a ,/ate plan am5dm5t "u ?is subsection ) respect to s]vices describ$ 9 p>agraph 7#a7 furni%$ to an eligible individual ) a t>get$ ,,sud %all n affect paym5t t w\ld o!rwise be made "u section #aijc7;a7 = exp5ditures "u ! ,/ate plan 7or waiv] ( su* plan7 = m$ical assi/ance = su* individual4 7#c7 ,in=mation requir$ 9 ,/ate plan am5dm5t 7,a7 ,9 g5]al ,a ,/ate elect+ to provide m$ical assi/ance pursuant to ?is subsection %all include ) ! submission ( ! ,/ate plan am5dm5t "u p>agraph 7#a7 to ! ,secret>y-- 7i7 a plan on h[ ! ,/ate w improve access to outpati5t c>e dur+ ! p]iod ( ! ,/ate plan am5dm5t1 includ+ a description (-- 7,i7 ! process by :i* eligible individuals ) t>get$ ,s,u,ds w make ! transition f receiv+ inpati5t s]vices 9 an in/itution = m5tal diseases to appropriate outpati5t c>e2 & 7,,ii7 ! process ! ,/ate w und]take to ensure eligible individuals ) t>get$ ,s,u,ds are provid$ c>e 9 ! mo/ integrat$ sett+ appropriate to ! ne$s ( ! individuals2 & 7ii7 a description ( h[ ! ,/ate plan am5dm5t ensures an appropriate cl9ical scre5+ ( eligible individuals ) t>get$ ,s,u,ds1 includ+ assessm5ts to det]m9e level ( c>e & l5g? ( /ay recomm5dations bas$ ^u ! multidim5sional assessm5t crit]ia ( ! ,am]ican ,society ( ,addiction ,m$ic9e & to det]m9e ! appropriate sett+ = su* c>e4 7,b7 ,report ,n lat] ?an ! soon] ( ,decemb] #ca1 #bjbd1 or #a ye> aft] ! date ( ! t]m9ation ( a ,/ate plan am5dm5t "u ?is subsection1 ! ,/ate %all submit to ! ,secret>y a report t includes at lea/-- 7i7 ! numb] ( eligible individuals ) t>get$ ,s,u,ds :o receiv$ s]vices pursuant to su* ,/ate plan am5dm5t2 7ii7 ! l5g? ( ! /ay ( ea* su* individual 9 an in/itution = m5tal diseases2 7iii7 ! type ( outpati5t treatm5t1 includ+ m$ication-assi/$ treatm5t1 ea* su* individual receiv$ aft] be+ dis*>g$ f su* in/itution2 7iv7 ! numb] ( eligible individuals ) any co-occur+ disord]s :o receiv$ s]vices pursuant to su* ,/ate plan am5dm5t & ! co-occur+ disord]s f :i* !y suff]2 & 7v7 in=mation reg>d+ ! effects ( a ,/ate plan am5dm5t on access to community c>e = individuals suff]+ f a m5tal disease o!r ?an sub/ance use disord]4 7#d7 ,def9itions ,9 ?is subsection3 7,a7 ,eligible individual ) a t>get$ ,,sud ,! t]m eligible individual ) a t>get$ ,,sud means an individual :o-- 7i7 ) respect to a ,/ate1 is enroll$ = m$ical assi/ance "u ! ,/ate plan 7or a waiv] ( su* plan72 7ii7 is at lea/ #ba ye>s ( age2 7iii7 has n atta9$ #fe ye>s ( age2 & 7iv7 has be5 diagnos$ ) at lea/ "o t>get$ ,,sud4 7,b7 ,in/itution = m5tal diseases ,! t]m in/itution = m5tal diseases has ! mean+ giv5 su* t]m 9 section #aije7;i74 7,c7 ,opioid prescription pa9 reliev] ,! t]m opioid prescription pa9 reliev] includes hydrocodone products1 oxycodone products1 tramadol products1 code9e products1 morph9e products1 f5tanyl products1 bupr5orph9e products1 oxymorphone products1 mep]id9e products1 hydromorphone products1 me?adone1 & any o!r prescription pa9 reliev] id5tifi$ by ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use4 7,d7 ,o!r m$ically necess>y s]vices ,! t]m o!r m$ically necess>y s]vices means1 ) respect to an eligible individual ) a t>get$ ,,sud :o is a pati5t 9 an in/itution = m5tal diseases1 items & s]vices t are provid$ to su* individual outside ( su* in/itution to ! ext5t t su* items & s]vices w\ld be treat$ z m$ical assi/ance = su* individual if su* individual 7 n a pati5t 9 su* in/itution4 7,e7 ,t>get$ ,,sud 7i7 ,9 g5]al ,! t]m t>get$ ,,sud means an opioid use disord] or a coca9e use disord]4 7ii7 ,coca9e use disord] ,! t]m coca9e use disord] means a disord] t meets ! crit]ia ( ! ,diagno/ic & ,/ati/ical ,manual ( ,m5tal ,disord]s1 #d? ,edition 7or a successor edition71 = ei!r dep5d5ce or abuse = coca9e1 includ+ coca9e base 7commonly ref]r$ to z crack coca9e74 7iii7 ,opioid use disord] ,! t]m opioid use disord] means a disord] t meets ! crit]ia ( ! ,diagno/ic & ,/ati/ical ,manual ( ,m5tal ,disord]s1 #d? ,edition 7or a successor edition71 = h]o9 use disord] or pa9 reliev] use disord] 7includ+ ) respect to opioid prescription pa9 reliev]s74 4 #aajjc4 ,promot+ value 9 ,m$icaid manag$ c>e ,section #aijc7m7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7m77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#g7 7,a7 ,) respect to exp5ditures describ$ 9 subp>agraph 7,b7 t are incurr$ by a ,/ate = any fiscal ye> aft] fiscal ye> #bjbj 7& be=e fiscal ye> #bjbd71 9 det]m9+ ! pro rata %>e to :i* ! ,unit$ ,/ates is equitably entitl$ "u subsection 7d77#c71 ! ,secret>y %all sub/itute ! ,f$]al m$ical assi/ance p]c5tage t applies = su* fiscal ye> to ! ,/ate "u section #aije7;b7 7)\t reg>d to any adju/m5ts to su* p]c5tage applicable "u su* section or any o!r provision ( law7 = ! p]c5tage t applies to su* exp5ditures "u section #aije7y74 7,b7 ,exp5ditures describ$ 9 ?is subp>agraph1 ) respect to a fiscal ye> to :i* subp>agraph 7,a7 applies1 are exp5ditures incurr$ by a ,/ate = paym5t = m$ical assi/ance provid$ to individuals describ$ 9 subclause 7,,viii7 ( section #aijb7;a77#aj77;,a77i7 by a manag$ c>e entity1 or o!r specifi$ entity 7z def9$ 9 subp>agraph 7,d77iii771 t are treat$ z remittances because ! ,/ate-- 7i7 has satisfi$ ! requirem5t ( section #dch4h ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation71 by elect+-- 7,i7 9 ! case ( a ,/ate describ$ 9 subp>agraph 7,c71 to apply a m9imum m$ical loss ratio 7z def9$ 9 subp>agraph 7,d77ii77 t is at lea/ #he p]c5t b n great] ?an ! m9imum m$ical loss ratio 7z s def9$7 t su* ,/ate appli$ z ( ,may #ca1 #bjah2 or 7,,ii7 9 ! case ( a ,/ate n describ$ 9 subp>agraph 7,c71 to apply a m9imum m$ical loss ratio t is equal to #he p]c5t2 & 7ii7 recov]$ all or a portion ( ! exp5ditures z a result ( ! entity's failure to meet su* ratio4 7,c7 ,= purposes ( subp>agraph 7,b71 a ,/ate describ$ 9 ?is subp>agraph is a ,/ate t z ( ,may #ca1 #bjah1 appli$ a m9imum m$ical loss ratio 7z calculat$ "u subsection 7d7 ( section #dch4h ( title #db1 ,code ( ,f$]al ,regulations 7z 9 effect on ,june #a1 #bjah77 = paym5t = s]vices provid$ by entities describ$ 9 su* subp>agraph "u ! ,/ate plan "u ?is title 7or a waiv] ( ! plan7 t is equal to or great] ?an #he p]c5t4 7,d7 ,= purposes ( ?is p>agraph3 7i7 ,! t]m manag$ c>e entity means a m$icaid manag$ c>e organization describ$ 9 section #aicb7;a77#a77;,b77i74 7ii7 ,! t]m m9imum m$ical loss ratio means1 ) respect to a ,/ate1 a m9imum m$ical loss ratio 7z calculat$ "u subsection 7d7 ( section #dch4h ( title #db1 ,code ( ,f$]al ,regulations 7z 9 effect on ,june #a1 #bjah77 = paym5t = s]vices provid$ by entities describ$ 9 subp>agraph 7,b7 "u ! ,/ate plan "u ?is title 7or a waiv] ( ! plan74 7iii7 ,! t]m o!r specifi$ entity means-- 7,i7 a prepaid inpati5t heal? plan1 z def9$ 9 section #dch4b ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation72 & 7,,ii7 a prepaid ambulatory heal? plan1 z def9$ 9 su* section 7or any successor regulation74 4 ,pass$ ! ,h\se ( ,repres5tatives ,june #bb1 #bjah4,k>5 ,l4 ,haas1,cl]k ,june #bf1 #bjah,read ! second "t & plac$ on ! cal5d>