,i #aae? ,,congress #b;d ,session ,h4 ,r4 #f ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,june #ac1 #bjah,mr4 ,wald5 7= himself1 ,mr4 ,pallone1 ,mr4 ,brady ( ,texas1 ,mr4 ,neal1 ,mr4 ,roe ( ,t5nessee1 ,mr4 ,%u/]1 ,ms4 ,foxx1 ,mr4 ,goodlatte1 ,mr4 ,walz1 ,mr4 ,de,fazio1 & ,mr4 ,burgess7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committees on ,ways & ,means1 & ! ,judici>y1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,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 = ! ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4 ,title ,i--,m$icaid ,provisions to ,address ! ,opioid ,crisis ,sec4 #aja4 ,at-risk y\? ,m$icaid protection4 ,sec4 #ajb4 ,heal? ,insurance = ,=m] ,fo/] ,y\?4 ,sec4 #ajc4 ,demon/ration project to increase sub/ance use provid] capacity "u ! ,m$icaid program4 ,sec4 #ajd4 ,drug managem5t program = at-risk b5efici>ies4 ,sec4 #aje4 ,m$icaid drug review & utilization4 ,sec4 #ajf4 ,guidance to improve c>e = infants ) neonatal ab/95ce syndrome & _! mo!rs2 ,,gao /udy on gaps 9 ,m$icaid cov]age = pregnant & po/p>tum wom5 ) sub/ance use disord]4 ,sec4 #ajg4 ,m$icaid heal? homes = opioid-use-disord] ,m$icaid enrollees4 ,title ,,ii--,m$ic>e ,provisions to ,address ! ,opioid ,crisis ,sec4 #bja4 ,au?ority n to apply c]ta9 ,m$ic>e teleheal? requirem5ts 9 ! case ( c]ta9 treatm5t ( a sub/ance use disord] or co-occurr+ m5tal heal? disord]4 ,sec4 #bjb4 ,enc\rag+ ! use ( non-opioid analgesics = ! managem5t ( po/-surgical pa94 ,sec4 #bjc4 ,requir+ a review ( curr5t opioid prescriptions = *ronic pa9 & scre5+ = opioid use disord] to be includ$ 9 ! ,welcome to ,m$ic>e initial prev5tive physical exam9ation4 ,sec4 #bjd4 ,modification ( paym5t = c]ta9 outpati5t surgical s]vices4 ,sec4 #bje4 ,requir+ e-prescrib+ = cov]age ( cov]$ "p ,d controll$ sub/ances4 ,sec4 #bjf4 ,requir+ prescription drug plan sponsors "u ,m$ic>e to e/abli% drug managem5t programs = at-risk b5efici>ies4 ,sec4 #bjg4 ,m$ic>e cov]age ( c]ta9 s]vices furni%$ by opioid treatm5t programs4 ,title ,,iii--,o!r ,heal? ,provisions to ,address ! ,opioid ,crisis ,sec4 #cja4 ,cl>ify+ ,,fda regulation ( non-addictive pa9 & addiction !rapies4 ,sec4 #cjb4 ,surveillance & ,te/+ ( ,opioids to ,prev5t ,f5tanyl ,dea?s4 ,sec4 #cjc4 ,all[+ = m flexibility ) respect to m$ication-assi/$ treatm5t = opioid use disord]s4 ,title ,,iv--,(fsets ,sec4 #dja4 ,promot+ value 9 ,m$icaid manag$ c>e4 ,sec4 #djb4 ,ext5d+ p]iod ( application ( ,m$ic>e second>y pay] rules = individuals ) end /age r5al disease4 ,sec4 #djc4 ,requir+ report+ by gr\p heal? plans ( prescription drug cov]age in=mation = purposes ( id5tify+ prim>y pay] situations "u ! ,m$ic>e program4 ,i ,m$icaid ,provisions to ,address ! ,opioid ,crisis #aja4 ,at-risk y\? ,m$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 #ajb4 ,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 "o 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$icaid cov]age to =m] fo/] y\? up to age #bf4 #ajc4 ,demon/ration project to increase sub/ance use provid] capacity "u ! ,m$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 ?ree 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 #ajd4 ,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 two 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 #aje4 ,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 #ajf4 ,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 "o 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 "o 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 #ajg4 ,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 #bja4 ,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 & 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 #bjb4 ,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 improvem5t2 & 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 #bjc4 ,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 c]tifi$ cl9ical nurse speciali/4 4 7b7 ,effective date ,! am5dm5ts made by subsection 7a7 %all apply ) respect to initial prev5tive physical exam9ations furni%$ on or aft] ,janu>y #a1 #bjbj4 #bjd4 ,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 #fbcaj 7or1 = ye>s beg9n+ aft] #bjaf1 #fbcba71 #fbcaa 7or1 = ye>s beg9n+ aft] #bjaf1 #fbcbc71 #fbbfd1 #fddij1 #fddic1 or ,g#jbfj 7or any successor code7 applies4 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$ures4 #bje4 ,requir+ e-prescrib+ = cov]age ( cov]$ "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$ "o 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 #bjf4 ,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 #bjg4 ,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 #cja4 ,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 "o 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$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;h7774 #cjb4 ,surveillance & ,te/+ ( ,opioids to ,prev5t ,f5tanyl ,dea?s 7a7 ,public heal? laboratories ,to detect f5tanyl ,"p ,f ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb et seq47 is am5d$-- 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 #cjc4 ,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 two 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 #ajj or m pati5ts1 & 9 ! case ( qualify+ practition]s :o are n physicians1 #cj or m 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 ! av]age frequ5cy ) :i* r&om toxicology te/+ is adm9i/]$2 7#d7 ! av]age mon?ly pati5t caseload = ea* type ( qualify+ practition]2 7#e7 ! treatm5t ret5tion rates = pati5ts2 7#f7 ov]dose & mortality rates2 & 7#g7 any available in=mation reg>d+ ! div]sion ( drugs by pati5ts receiv+ su* treatm5t f su* a qualify+ practition]4 ,,iv ,(fsets #dja4 ,promot+ value 9 ,m$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> #bjbe71 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 equal to or great] ?an #he p]c5t2 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 #djb4 ,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 #djc4 ,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