,,ii #aaf? ,,congress #a/ ,session ,h4 ,r4 #ahci ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,m>* #bf1 #bjai,receiv$ ,,an ,,act ,to am5d title ,,xix to ext5d protection = ,m$icaid recipi5ts ( home & community-bas$ s]vices aga9/ sp\sal impov]i%m5t1 e/abli% a ,/ate ,m$icaid option to provide coord9at$ c>e to *ildr5 ) complex m$ical conditions ?r\gh heal? homes1 prev5t ! misclassification ( drugs = purposes ( ! ,m$icaid drug rebate program1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,m$icaid ,s]vices ,inve/m5t & ,acc\ntability ,act ( #bjai4 #b4 ,ext5sion ( protection = ,m$icaid recipi5ts ( home & community-bas$ s]vices aga9/ sp\sal impov]i%m5t 7a7 ,9 g5]al ,section #bdjd ( ,public ,law #aaa-adh 7#db ,u4,s4,c4 #acifr-#e note71 z am5d$ by section #c7;a7 ( ! ,m$icaid ,ext5d]s ,act ( #bjai 7,public ,law #aaf-c71 is am5d$ by /rik+ ,m>* #ca1 #bjai & ins]t+ ,septemb] #cj1 #bjai4 7b7 ,rule ( con/ruction 7#a7 ,protect+ ,/ate sp\sal income & asset disreg>d flexibility "u waiv]s & plan am5dm5ts ,no?+ 9 section #bdjd ( ,public ,law #aaa-adh 7#db ,u4,s4,c4 #acifr-#e note7 or section #aibd ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#e7 %all be con/ru$ z prohibit+ a ,/ate f disreg>d+ an individual's sp\sal income & assets "u a ,/ate waiv] or plan am5dm5t describ$ 9 p>agraph 7#b7 = purposes ( mak+ det]m9ations ( eligibility = home & community-bas$ s]vices or home & community-bas$ att5dant s]vices & supports "u su* waiv] or plan am5dm5t4 7#b7 ,/ate waiv] or plan am5dm5t describ$ ,a ,/ate waiv] or plan am5dm5t describ$ 9 ?is p>agraph is any ( ! foll[+3 7,a7 ,a waiv] or plan am5dm5t to provide m$ical assi/ance = home & community-bas$ s]vices "u a waiv] or plan am5dm5t "u subsection 7c71 7d71 or 7i7 ( section #aiae ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifn7 or "u section #aaae ( su* ,act 7#db ,u4,s4,c4 #acae74 7,b7 ,a plan am5dm5t to provide m$ical assi/ance = home & community-bas$ s]vices = individuals by reason ( be+ det]m9$ eligible "u section #aijb7;a77#aj77;,c7 ( su* ,act 7#db ,u4,s4,c4 #acif;a7a77#aj77;,c77 or by reason ( section #aijb7;f7 ( su* ,act 7#db ,u4,s4,c4 #acif;a7f77 or o!rwise on ! basis ( a r$uction ( income bas$ on co/s incurr$ = m$ical or o!r rem$ial c>e "u :i* ! ,/ate disreg>d$ ! income & assets ( ! individual's sp\se 9 det]m9+ ! initial & ongo+ f9ancial eligibility ( an individual = su* s]vices 9 place ( ! sp\sal impov]i%m5t provisions appli$ "u section #aibd ( su* ,act 7#db ,u4,s4,c4 #acifr-#e74 7,c7 ,a plan am5dm5t to provide m$ical assi/ance = home & community-bas$ att5dant s]vices & supports "u section #aiae7k7 ( su* ,act 7#db ,u4,s4,c4 #acifn7k774 #c4 ,/ate option to provide coord9at$ c>e ?r\gh a heal? home = *ildr5 ) m$ically complex conditions ,title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 is am5d$ by ins]t+ aft] section #aide ! foll[+ new section3 #aide;,a4 ,/ate option to provide coord9at$ c>e ?r\gh a heal? home = *ildr5 ) m$ically complex conditions 7a7 ,9 g5]al ,not)/&+ section #aijb7;a77#a7 7relat+ to /atewid5ess7 & section #aijb7;a77#aj77;,b7 7relat+ to comp>ability71 beg9n+ ,octob] #a1 #bjbb1 a ,/ate1 at its option z a ,/ate plan am5dm5t1 may provide = m$ical assi/ance "u ?is title to *ildr5 ) m$ically complex conditions :o *oose to enroll 9 a heal? home "u ?is section by select+ a designat$ provid]1 a team ( heal? c>e pr(essionals op]at+ ) su* a provid]1 or a heal? team z ! *ild's heal? home = purposes ( provid+ ! *ild ) heal? home s]vices4 7b7 ,heal? home qualification /&>ds ,! ,secret>y %all e/abli% /&>ds = qualification z a heal? home = purposes ( ?is section4 ,su* /&>ds %all include requir+ designat$ provid]s1 teams ( heal? c>e pr(essionals op]at+ ) su* provid]s1 & heal? teams to demon/rate to ! ,/ate ! ability to d ! foll[+3 7#a7 ,coord9ate prompt c>e = *ildr5 ) m$ically complex conditions1 includ+ access to p$iatric em]g5cy s]vices at all times4 7#b7 ,develop an individualiz$ compreh5sive p$iatric family-c5t]$ c>e plan = *ildr5 ) m$ically complex conditions t accommodates pati5t pref]5ces4 7#c7 ,"w 9 a culturally & l+ui/ically appropriate mann] ) ! family ( a *ild ) m$ically complex conditions to develop & incorporate into su* *ild's c>e plan1 9 a mann] consi/5t ) ! ne$s ( ! *ild & ! *oices ( ! *ild's family1 ongo+ home c>e1 community-bas$ p$iatric prim>y c>e1 p$iatric inpati5t c>e1 social support s]vices1 & local hospital p$iatric em]g5cy c>e4 7#d7 ,coord9ate access to-- 7,a7 subspecializ$ p$iatric s]vices & programs = *ildr5 ) m$ically complex conditions1 includ+ ! mo/ int5sive diagno/ic1 treatm5t1 & critical c>e levels z m$ically necess>y2 & 7,b7 palliative s]vices if ! ,/ate provides su* s]vices "u ! ,/ate plan 7or a waiv] ( su* plan74 7#e7 ,coord9ate c>e = *ildr5 ) m$ically complex conditions ) out-(-,/ate provid]s furni%+ c>e to su* *ildr5 to ! maximum ext5t practicable = ! families ( su* *ildr5 & :]e m$ically necess>y1 9 accordance ) guidance issu$ "u subsection 7e77#a7 & section #dca4eb ( title #db1 ,code ( ,f$]al ,regulations4 7#f7 ,collect & report in=mation "u subsection 7g77#a74 7c7 ,paym5ts 7#a7 ,9 g5]al ,a ,/ate %all provide a designat$ provid]1 a team ( heal? c>e pr(essionals op]at+ ) su* a provid]1 or a heal? team ) paym5ts = ! provision ( heal? home s]vices to ea* *ild ) m$ically complex conditions t selects su* provid]1 team ( heal? c>e pr(essionals1 or heal? team z ! *ild's heal? home4 ,paym5ts made to a designat$ provid]1 a team ( heal? c>e pr(essionals op]at+ ) su* a provid]1 or a heal? team = su* s]vices %all be treat$ z m$ical assi/ance = purposes ( section #aijc7;a71 except t1 dur+ ! fir/ #b fiscal ye> qu>t]s t ! ,/ate plan am5dm5t is 9 effect1 ! ,f$]al m$ical assi/ance p]c5tage applicable to su* paym5ts %all be increas$ by #ae p]c5tage po9ts1 b 9 no case may exce$ #ij p]c5t4 7#b7 ,me?odology 7,a7 ,9 g5]al ,! ,/ate %all specify 9 ! ,/ate plan am5dm5t ! me?odology ! ,/ate w use = det]m9+ paym5t = ! provision ( heal? home s]vices4 ,su* me?odology = det]m9+ paym5t-- 7i7 may be ti]$ to reflect1 ) respect to ea* *ild ) m$ically complex conditions provid$ su* s]vices by a designat$ provid]1 a team ( heal? c>e pr(essionals op]at+ ) su* a provid]1 or a heal? team1 ! sev]ity or numb] ( ea* su* *ild's *ronic conditions1 life-?reat5+ illnesses1 disabilities1 or r>e diseases1 or ! specific capabilities ( ! provid]1 team ( heal? c>e pr(essionals1 or heal? team2 & 7ii7 %all be e/abli%$ consi/5t ) section #aijb7;a77#cj77;,a74 7,b7 ,alt]nate models ( paym5t ,! me?odology = det]m9+ paym5t = provision ( heal? home s]vices "u ?is section %all n be limit$ to a p]-memb] p]-mon? basis & may provide 7z propos$ by ! ,/ate & subject to approval by ! ,secret>y7 = alt]nate models ( paym5t4 7#c7 ,plann+ grants 7,a7 ,9 g5]al ,beg9n+ ,octob] #a1 #bjbb1 ! ,secret>y may aw>d plann+ grants to ,/ates = purposes ( develop+ a ,/ate plan am5dm5t "u ?is section4 ,a plann+ grant aw>d$ to a ,/ate "u ?is p>agraph %all rema9 available until exp5d$4 7,b7 ,/ate contribution ,a ,/ate aw>d$ a plann+ grant %all contribute an am\nt equal to ! ,/ate p]c5tage det]m9$ "u section #aije7;b7 7)\t reg>d to section #ejja ( ,public ,law #aaa-e7 = ea* fiscal ye> = :i* ! grant is aw>d$4 7,c7 ,limitation ,! total am\nt ( paym5ts made to ,/ates "u ?is p>agraph %all n exce$ #e1jjj1jjj4 7d7 ,coord9at+ c>e 7#a7 ,hospital notification ,a ,/ate ) a ,/ate plan am5dm5t approv$ "u ?is section %all require ea* hospital t is a p>ticipat+ provid] "u ! ,/ate plan 7or a waiv] ( su* plan7 to e/abli% proc$ures =1 9 ! case ( a *ild ) m$ically complex conditions :o is enroll$ 9 a heal? home pursuant to ?is section & seeks treatm5t 9 ! em]g5cy dep>tm5t ( su* hospital1 notify+ ! heal? home ( su* *ild ( su* treatm5t4 7#b7 ,education ) respect to availability ( heal? home s]vices ,9 ord] = a ,/ate plan am5dm5t to be approv$ "u ?is section1 a ,/ate %all include 9 ! ,/ate plan am5dm5t a description ( ! ,/ate's process = educat+ provid]s p>ticipat+ 9 ! ,/ate plan 7or a waiv] ( su* plan7 on ! availability ( heal? home s]vices = *ildr5 ) m$ically complex conditions1 includ+ ! process by :i* su* provid]s c ref] su* *ildr5 to a designat$ provid]1 team ( heal? c>e pr(essionals op]at+ su* a provid]1 or heal? team = ! purpose ( e/abli%+ a heal? home ?r\gh :i* su* *ildr5 may receive su* s]vices4 7#c7 ,family education ,9 ord] = a ,/ate plan am5dm5t to be approv$ "u ?is section1 a ,/ate %all include 9 ! ,/ate plan am5dm5t a description ( ! ,/ate's process = educat+ families ) *ildr5 eligible to receive heal? home s]vices pursuant to ?is section ( ! availability ( su* s]vices4 ,su* process %all include ! p>ticipation ( family-to-family entities or o!r public or private organizations or entities :o provide outrea* & in=mation on ! availability ( heal? c>e items & s]vices to families ( individuals eligible to receive m$ical assi/ance "u ! ,/ate plan 7or a waiv] ( su* plan74 7#d7 ,m5tal heal? coord9ation ,a ,/ate ) a ,/ate plan am5dm5t approv$ "u ?is section %all consult & coord9ate1 z appropriate1 ) ! ,secret>y 9 address+ issues reg>d+ ! prev5tion & treatm5t ( m5tal illness & sub/ance use among *ildr5 ) m$ically complex conditions receiv+ heal? home s]vices "u ?is section4 7e7 ,guidance on coord9at+ c>e f out-(-,/ate provid]s 7#a7 ,9 g5]al ,n lat] ?an ,octob] #a1 #bjbj1 ! ,secret>y %all issue 7& update z ! ,secret>y det]m9es necess>y7 guidance to ,/ate ,m$icaid directors on-- 7,a7 be/ practices = us+ out-(-,/ate provid]s to provide c>e to *ildr5 ) m$ically complex conditions2 7,b7 coord9at+ c>e = su* *ildr5 provid$ by su* out-(-,/ate provid]s 7includ+ :5 provid$ 9 em]g5cy & non-em]g5cy situations72 7,c7 r$uc+ b>ri]s = su* *ildr5 receiv+ c>e f su* provid]s 9 a timely fa%ion2 & 7,d7 processes = scre5+ & enroll+ su* provid]s 9 ! respective ,/ate plan 7or a waiv] ( su* plan71 includ+ ef=ts to /reaml9e su* processes or r$uce ! burd5 ( su* processes on su* provid]s4 7#b7 ,/akehold] input ,9 c>ry+ out p>agraph 7#a71 ! ,secret>y %all issue a reque/ = in=mation to seek input f *ildr5 ) m$ically complex conditions & _! families1 ,/ates1 provid]s 7includ+ *ildr5's hospitals1 hospitals1 p$iatricians1 & o!r provid]s71 manag$ c>e plans1 *ildr5's heal? gr\ps1 family & b5efici>y advocates1 & o!r /akehold]s ) respect to coord9at+ ! c>e = su* *ildr5 provid$ by out-(-,/ate provid]s4 7f7 ,monitor+ ,a ,/ate %all include 9 ! ,/ate plan am5dm5t-- 7#a7 a me?odology = track+ r$uctions 9 inpati5t days & r$uctions 9 ! total co/ ( c>e result+ f improv$ c>e coord9ation & managem5t "u ?is section2 7#b7 a proposal = use ( heal? in=mation te*nology 9 provid+ heal? home s]vices "u ?is section & improv+ s]vice deliv]y & coord9ation across ! c>e cont9uum 7includ+ ! use ( wireless pati5t te*nology to improve coord9ation & managem5t ( c>e & pati5t adh]5ce to recomm5dations made by _! provid]72 & 7#c7 a me?odology = track+ prompt & timely access to m$ically necess>y c>e = *ildr5 ) m$ically complex conditions f out-(-,/ate provid]s4 7g7 ,data collection 7#a7 ,provid] report+ requirem5ts ,9 ord] to receive paym5ts f a ,/ate "u subsection 7c71 a designat$ provid]1 a team ( heal? c>e pr(essionals op]at+ ) su* a provid]1 or a heal? team %all report to ! ,/ate1 at su* "t & 9 su* =m & mann] z may be requir$ by ! ,/ate1 ! foll[+ in=mation3 7,a7 ,) respect to ea* su* provid]1 team ( heal? c>e pr(essionals1 or heal? team1 ! "n1 ,national ,provid] ,id5tification numb]1 address1 & specific heal? c>e s]vices (f]$ to be provid$ to *ildr5 ) m$ically complex conditions :o h select$ su* provid]1 team ( heal? c>e pr(essionals1 or heal? team z ! heal? home ( su* *ildr54 7,b7 ,in=mation on all applicable measures = det]m9+ ! quality ( heal? home s]vices provid$ by su* provid]1 team ( heal? c>e pr(essionals1 or heal? team1 includ+1 to ! ext5t applicable1 *ild heal? quality measures & measures = c5t]s ( excell5ce = *ildr5 ) complex ne$s develop$ "u ?is title1 title ,,xxi1 & section #aaci;,a4 7,c7 ,su* o!r in=mation z ! ,secret>y %all specify 9 guidance4 ,:5 appropriate & feasible1 su* provid]1 team ( heal? c>e pr(essionals1 or heal? team1 z ! case may be1 %all use heal? in=mation te*nology 9 provid+ ! ,/ate ) su* in=mation4 7#b7 ,/ate report+ requirem5ts 7,a7 ,compreh5sive report ,a ,/ate ) a ,/ate plan am5dm5t approv$ "u ?is section %all report to ! ,secret>y 7&1 ^u reque/1 to ! ,m$icaid & ,,*ip ,paym5t & ,access ,commission71 at su* "t & 9 su* =m & mann] det]m9$ by ! ,secret>y to be reasonable & m9imally burd5some1 ! foll[+ in=mation3 7i7 ,in=mation report$ "u p>agraph 7#a74 7ii7 ,! numb] ( *ildr5 ) m$ically complex conditions :o h select$ a heal? home pursuant to ?is section4 7iii7 ,! nature1 numb]1 & preval5ce ( *ronic conditions1 life-?reat5+ illnesses1 disabilities1 or r>e diseases t su* *ildr5 h4 7iv7 ,! type ( deliv]y sy/ems & paym5t models us$ to provide s]vices to su* *ildr5 "u ?is section4 7v7 ,! numb] & *>act]i/ics ( designat$ provid]s1 teams ( heal? c>e pr(essionals op]at+ ) su* provid]s1 & heal? teams select$ z heal? homes pursuant to ?is section1 includ+ ! numb] & *>act]i/ics ( out-(-,/ate provid]s1 teams ( heal? c>e pr(essionals op]at+ ) su* provid]s1 & heal? teams :o h provid$ heal? c>e items & s]vices to su* *ildr54 7vi7 ,! ext5t to :i* su* *ildr5 receive heal? c>e items & s]vices "u ! ,/ate plan4 7vii7 ,quality measures develop$ specifically ) respect to heal? c>e items & s]vices provid$ to *ildr5 ) m$ically complex conditions4 7,b7 ,report on be/ practices ,n lat] ?an #ij days aft] a ,/ate has a ,/ate plan am5dm5t approv$ "u ?is section1 su* ,/ate %all submit to ! ,secret>y1 & make publicly available on ! appropriate ,/ate website1 a report on h[ ! ,/ate is implem5t+ guidance issu$ "u subsection 7e77#a71 includ+ ?r\gh any be/ practices adopt$ by ! ,/ate4 7h7 ,rule ( con/ruction ,no?+ 9 ?is section may be con/ru$-- 7#a7 to require a *ild ) m$ically complex conditions to enroll 9 a heal? home "u ?is section2 7#b7 to limit ! *oice ( a *ild ) m$ically complex conditions 9 select+ a designat$ provid]1 team ( heal? c>e pr(essionals op]at+ ) su* a provid]1 or heal? team t meets ! heal? home qualification /&>ds e/abli%$ "u subsection 7b7 z ! *ild's heal? home2 or 7#c7 to r$uce or o!rwise modify-- 7,a7 ! entitlem5t ( *ildr5 ) m$ically complex conditions to e>ly & p]iodic scre5+1 diagno/ic1 & treatm5t s]vices 7z def9$ 9 section #aije7r772 or 7,b7 ! in=m+1 provid+1 arrang+1 & report+ requirem5ts ( a ,/ate "u section #aijb7;a77#dc74 7i7 ,def9itions ,9 ?is section3 7#a7 ,*ild ) m$ically complex conditions 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 ! t]m *ild ) m$ically complex conditions means an individual "u #ba ye>s ( age :o-- 7i7 is eligible = m$ical assi/ance "u ! ,/ate plan 7or "u a waiv] ( su* plan72 & 7ii7 has at lea/-- 7,i7 "o or m *ronic conditions t cumulatively affect ?ree or m organ sy/ems & sev]ely r$uces cognitive or physical function+ 7su* z ! ability to eat1 dr9k1 or brea! indep5d5tly7 & t also requires ! use ( m$ication1 durable m$ical equipm5t1 !rapy1 surg]y1 or o!r treatm5ts2 or 7,,ii7 "o life-limit+ illness or r>e p$iatric disease 7z def9$ 9 section #ebi7;a77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7a77#c7774 7,b7 ,rule ( con/ruction ,no?+ 9 ?is p>agraph %all prev5t ! ,secret>y f e/abli%+ high] levels z to ! numb] or sev]ity ( *ronic1 life ?reat5+ illnesses1 disabilities1 r>e diseases or m5tal heal? conditions = purposes ( det]m9+ eligibility = receipt ( heal? home s]vices "u ?is section4 7#b7 ,*ronic condition ,! t]m *ronic condition means a s]i\s1 long-t]m physical1 m5tal1 or developm5tal disability or disease1 includ+ ! foll[+3 7,a7 ,c]ebral palsy4 7,b7 ,cy/ic fibrosis4 7,c7 ,,hiv_/,,aids4 7,d7 ,blood diseases1 su* z anemia or sickle cell disease4 7,e7 ,muscul> dy/rophy4 7,f7 ,sp9a bifida4 7,g7 ,epilepsy4 7,h7 ,sev]e autism spectrum disord]4 7,i7 ,s]i\s emotional di/urbance or s]i\s m5tal heal? illness4 7#c7 ,heal? home ,! t]m heal? home means a designat$ provid] 7includ+ a provid] t op]ates 9 coord9ation ) a team ( heal? c>e pr(essionals7 or a heal? team select$ by a *ild ) m$ically complex conditions 7or ! family ( su* *ild7 to provide heal? home s]vices4 7#d7 ,heal? home s]vices 7,a7 ,9 g5]al ,! t]m heal? home s]vices means compreh5sive & timely high-quality s]vices describ$ 9 subp>agraph 7,b7 t are provid$ by a designat$ provid]1 a team ( heal? c>e pr(essionals op]at+ ) su* a provid]1 or a heal? team4 7,b7 ,s]vices describ$ ,! s]vices describ$ 9 ?is subp>agraph %all include-- 7i7 compreh5sive c>e managem5t2 7ii7 c>e coord9ation1 heal? promotion1 & provid+ access to ! full range ( p$iatric specialty & subspecialty m$ical s]vices1 includ+ s]vices f out-(-,/ate provid]s1 z m$ically necess>y2 7iii7 compreh5sive transitional c>e1 includ+ appropriate foll[-up1 f inpati5t to o!r sett+s2 7iv7 pati5t & family support 7includ+ au?oriz$ repres5tatives72 7v7 ref]rals to community & social support s]vices1 if relevant2 & 7vi7 use ( heal? in=mation te*nology to l9k s]vices1 z feasible & appropriate4 7#e7 ,designat$ provid] ,! t]m designat$ provid] means a physician 7includ+ a p$iatrician or a p$iatric specialty or subspecialty provid]71 *ildr5's hospital1 cl9ical practice or cl9ical gr\p practice1 prepaid inpati5t heal? plan or prepaid ambulatory heal? plan 7z def9$ by ! ,secret>y71 rural cl9ic1 community heal? c5t]1 community m5tal heal? c5t]1 home heal? ag5cy1 or any o!r entity or provid] t is det]m9$ by ! ,/ate & approv$ by ! ,secret>y to be qualifi$ to be a heal? home = *ildr5 ) m$ically complex conditions on ! basis ( docum5tation evid5c+ t ! entity has ! sy/ems1 exp]tise1 & infra/ructure 9 place to provide heal? home s]vices4 ,su* t]m may include provid]s :o are employ$ by1 or affiliat$ )1 a *ildr5's hospital4 7#f7 ,team ( heal? c>e pr(essionals ,! t]m team ( heal? c>e pr(essionals means a team ( heal? c>e pr(essionals 7z describ$ 9 ! ,/ate plan am5dm5t "u ?is section7 t may-- 7,a7 include-- 7i7 physicians & o!r pr(essionals1 su* z p$iatricians or p$iatric specialty or subspecialty provid]s1 nurse c>e coord9ators1 dietitians1 nutritioni/s1 social work]s1 behavioral heal? pr(essionals1 physical !rapi/s1 occupational !rapi/s1 spee* pa?ologi/s1 nurses1 individuals ) exp]i5ce 9 m$ical supportive te*nologies1 or any pr(essionals det]m9$ to be appropriate by ! ,/ate & approv$ by ! ,secret>y2 7ii7 an entity or individual :o is designat$ to coord9ate su* a team2 & 7iii7 community heal? work]s1 translators1 & o!r individuals ) culturally-appropriate exp]tise2 & 7,b7 be free/&+1 virtual1 or bas$ at a *ildr5's hospital1 hospital1 community heal? c5t]1 community m5tal heal? c5t]1 rural cl9ic1 cl9ical practice or cl9ical gr\p practice1 academic heal? c5t]1 or any entity det]m9$ to be appropriate by ! ,/ate & approv$ by ! ,secret>y4 7#g7 ,heal? team ,! t]m heal? team has ! mean+ giv5 su* t]m = purposes ( section #cejb ( ,public ,law #aaa-adh4 4 #d4 ,ext5sion ( ! community m5tal heal? s]vices demon/ration program ,section #bbc7;d77#c7 ( ! ,protect+ ,access to ,m$ic>e ,act ( #bjad 7#db ,u4,s4,c4 #acif;a note7 is am5d$ by /rik+ = #b-ye> demon/ration programs "u ?is subsection & ins]t+ to conduct demon/ration programs "u ?is subsection = #b ye>s or ?r\gh ,june #cj1 #bjai1 :i*ev] is long]4 #e4 ,additional fund+ = ! ,money ,foll[s ! ,p]son ,rebalanc+ ,demon/ration ,section #fjga7;h77#a77;,f7 ( ! ,deficit ,r$uction ,act ( #bjje 7#db ,u4,s4,c4 #acif;a note7 is am5d$ by /rik+ #aab1jjj1jjj & ins]t+ #acb1jjj1jjj4 #f4 ,prev5t+ ! misclassification ( drugs "u ! ,m$icaid drug rebate program 7a7 ,application ( civil money p5alty = misclassification ( cov]$ outpati5t drugs 7#a7 ,9 g5]al ,section #aibg7;b77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77 is am5d$-- 7,a7 9 ! p>agraph head+1 by ins]t+ & drug product aft] price2 7,b7 9 subp>agraph 7,a7-- 7i7 9 clause 7ii71 by /rik+ 2 & at ! end & ins]t+ a semicolon2 7ii7 9 clause 7iii71 by /rik+ ! p]iod at ! end & ins]t+ a semicolon2 7iii7 9 clause 7iv71 by /rik+ ! semicolon at ! end & ins]t+ 2 &2 & 7iv7 by ins]t+ aft] clause 7iv7 ! foll[+ new clause3 7v7 n lat] ?an #cj days aft] ! la/ day ( ea* mon? ( a rebate p]iod "u ! agreem5t1 su* drug product in=mation z ! ,secret>y %all require = ea* ( ! manufactur]'s cov]$ outpati5t drugs4 2 & 7,c7 9 subp>agraph 7,c7-- 7i7 9 clause 7ii71 by ins]t+ 1 includ+ in=mation relat$ to drug pric+1 drug product in=mation1 & data relat$ to drug pric+ or drug product in=mation1 aft] provides false in=mation2 7ii7 by add+ at ! end ! foll[+ new clauses3 7iii7 ,misclassifi$ drug product or misreport$ in=mation 7,i7 ,9 g5]al ,any manufactur] ) an agreem5t "u ?is section t kn[+ly 7z def9$ 9 section #ajjc4aaj ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation77 misclassifies a cov]$ outpati5t drug1 su* z by kn[+ly submitt+ incorrect drug product in=mation1 is subject to a civil money p5alty = ea* cov]$ outpati5t drug t is misclassifi$ 9 an am\nt n to exce$ #b times ! am\nt ( ! diff]5ce betwe5-- 7aa7 ! total am\nt ( rebates t ! manufactur] paid ) respect to ! drug to all ,/ates = all rebate p]iods dur+ :i* ! drug 0 misclassifi$2 & 7bb7 ! total am\nt ( rebates t ! manufactur] w\ld h be5 requir$ to pay1 z det]m9$ by ! ,secret>y us+ drug product in=mation provid$ by ! manufactur]1 ) respect to ! drug to all ,/ates = all rebate p]iods dur+ :i* ! drug 0 misclassifi$ if ! drug _h be5 correctly classifi$4 7,,ii7 ,o!r p5alties & recov]y ( und]paid rebates ,! civil money p5alties describ$ 9 subclause 7,i7 are 9 addition to o!r p5alties z may be prescrib$ by law & any o!r recov]y ( ! und]ly+ und]paym5t = rebates due "u ?is section or ! t]ms ( ! rebate agreem5t z det]m9$ by ! ,secret>y4 7iv7 ,increas+ ov]sight & en=cem5t ,ea* ye> ! ,secret>y %all reta91 9 addition to any am\nt reta9$ by ! ,secret>y to rec\p inve/igation & litigation co/s relat$ to ! en=cem5t ( ! civil money p5alties "u ?is subp>agraph & subsection 7c77#d77;,b77ii77,,iii71 an am\nt equal to #be p]c5t ( ! total am\nt ( civil money p5alties collect$ "u ?is subp>agraph & subsection 7c77#d77;,b77ii77,,iii7 = ! ye>1 & su* reta9$ am\nt %all be available to ! ,secret>y1 )\t fur!r appropriation & until exp5d$1 = activities relat$ to ! ov]sight & en=cem5t ( ?is section & agreem5ts "u ?is section1 includ+-- 7,i7 improv+ drug data report+ sy/ems2 7,,ii7 evaluat+ & ensur+ manufactur] compliance ) rebate obligations2 & 7,,iii7 ov]sight & en=cem5t relat$ to ensur+ t manufactur]s accurately & fully report drug in=mation1 includ+ data relat$ to drug classification4 2 & 7iii7 9 subp>agraph 7,d7-- 7,i7 9 clause 7iv71 by /rik+ 1 & & ins]t+ a comma2 7,,ii7 9 clause 7v71 by /rik+ ! p]iod & ins]t+ 1 &2 & 7,,iii7 by ins]t+ aft] clause 7v7 ! foll[+ new clause3 7vi7 9 ! case ( categories ( drug product or classification in=mation t 7 n consid]$ confid5tial by ! ,secret>y on ! day be=e ! date ( ! enactm5t ( ?is clause4 4 7#b7 ,te*nical am5dm5ts 7,a7 ,section #aijc7;i77#aj7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7i77#aj77 is am5d$-- 7i7 9 subp>agraph 7,c7-- 7,i7 by adju/+ ! left m>g9 s z to align ) ! left m>g9 ( subp>agraph 7,b72 & 7,,ii7 by /rik+ 1 & & ins]t+ a semicolon2 7ii7 9 subp>agraph 7,d71 by /rik+ 2 or & ins]t+ 2 &2 & 7iii7 by add+ at ! end ! foll[+ new subp>agraph3 7,e7 ) respect to any am\nt exp5d$ = a cov]$ outpati5t drug = :i* a susp5sion "u section #aibg7;c77#d77;,b77ii77,,ii7 is 9 effect2 or 4 7,b7 ,section #aibg7;b77#c77;,c77ii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,c77ii77 is am5d$ by /rik+ subsections 7a7 & 7b7 & ins]t+ subsections 7a71 7b71 7f77#c71 & 7f77#d74 7b7 ,recov]y ( unpaid rebate am\nts due to misclassification ( cov]$ outpati5t drugs 7#a7 ,9 g5]al ,section #aibg7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#d7 ,recov]y ( unpaid rebate am\nts due to misclassification ( cov]$ outpati5t drugs 7,a7 ,9 g5]al ,if ! ,secret>y det]m9es t a manufactur] ) an agreem5t "u ?is section paid a l[] p]-unit rebate am\nt to a ,/ate = a rebate p]iod z a result ( ! misclassification by ! manufactur] ( a cov]$ outpati5t drug 7)\t reg>d to :e!r ! manufactur] kn[+ly made ! misclassification or %\ld h kn[n t ! misclassification w\ld be made7 ?an ! p]-unit rebate am\nt t ! manufactur] w\ld h paid to ! ,/ate if ! drug _h be5 correctly classifi$1 ! manufactur] %all pay to ! ,/ate an am\nt equal to ! product (-- 7i7 ! diff]5ce betwe5-- 7,i7 ! p]-unit rebate am\nt paid to ! ,/ate = ! p]iod2 & 7,,ii7 ! p]-unit rebate am\nt t ! manufactur] w\ld h paid to ! ,/ate = ! p]iod1 z det]m9$ by ! ,secret>y1 if ! drug _h be5 correctly classifi$2 & 7ii7 ! total units ( ! drug paid = "u ! ,/ate plan 9 ! p]iod4 7,b7 ,au?ority to correct misclassifications 7i7 ,9 g5]al ,if ! ,secret>y det]m9es t a manufactur] ) an agreem5t "u ?is section has misclassifi$ a cov]$ outpati5t drug 7)\t reg>d to :e!r ! manufactur] kn[+ly made ! misclassification or %\ld h kn[n t ! misclassification w\ld be made71 ! ,secret>y %all notify ! manufactur] ( ! misclassification & require ! manufactur] to correct ! misclassification 9 a timely mann]4 7ii7 ,en=cem5t ,if1 aft] receiv+ notice ( a misclassification f ! ,secret>y "u clause 7i71 a manufactur] fails to correct ! misclassification by su* "t z ! ,secret>y %all require1 until ! manufactur] makes su* correction1 ! ,secret>y may d any or all ( ! foll[+3 7,i7 ,correct ! misclassification1 us+ drug product in=mation provid$ by ! manufactur]1 on behalf ( ! manufactur]4 7,,ii7 ,susp5d ! misclassifi$ drug & ! drug's /atus z a cov]$ outpati5t drug "u ! manufactur]'s national rebate agreem5t1 & exclude ! misclassifi$ drug f ,f$]al f9ancial p>ticipation 9 accordance ) section #aijc7;i77#aj77;,e74 7,,iii7 ,impose a civil money p5alty 7:i* %all be 9 addition to any o!r recov]y or p5alty :i* may be available "u ?is section or any o!r provision ( law7 = ea* rebate p]iod dur+ :i* ! drug is misclassifi$ n to exce$ an am\nt equal to ! product (-- 7aa7 ! total numb] ( units ( ea* dosage =m & /r5g? ( su* misclassifi$ drug paid = "u any ,/ate plan dur+ su* a rebate p]iod2 & 7bb7 #bc4a p]c5t ( ! av]age manufactur] price = ! dosage =m & /r5g? ( su* misclassifi$ drug4 7,c7 ,report+ & transp>5cy 7i7 ,9 g5]al ,! ,secret>y %all submit a report to ,congress on at lea/ an annual basis t includes in=mation on ! cov]$ outpati5t drugs t h be5 id5tifi$ z misclassifi$1 any /eps tak5 to reclassify su* drugs1 ! actions ! ,secret>y has tak5 to ensure ! paym5t ( any rebate am\nts :i* 7 unpaid z a result ( su* misclassification1 & a disclosure ( exp5ditures f ! fund creat$ 9 subsection 7b77#c77;,c77iv71 includ+ an acc\nt+ ( h[ su* funds h be5 allocat$ & sp5t 9 accordance ) su* subsection4 7ii7 ,public access ,! ,secret>y %all make ! in=mation conta9$ 9 ! report requir$ "u clause 7i7 available to ! public on a timely basis4 7,d7 ,o!r p5alties & actions ,actions tak5 & p5alties impos$ "u ?is clause %all be 9 addition to o!r rem$ies available to ! ,secret>y includ+ t]m9at+ ! manufactur]'s rebate agreem5t = noncompliance ) ! t]ms ( su* agreem5t & %all n exempt a manufactur] f1 or preclude ! ,secret>y f pursu+1 any civil money p5alty "u ?is title or title ,,xi1 or any o!r p5alty or action z may be prescrib$ by law4 4 7#b7 ,(fset ( recov]$ am\nts aga9/ m$ical assi/ance ,section #aibg7;b77#a77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#a77;,b77 is am5d$ by ins]t+ 1 includ+ am\nts receiv$ by a ,/ate "u subsection 7c77#d71 aft] 9 any qu>t]4 7c7 ,cl>ify+ def9itions ,section #aibg7k7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77 is am5d$-- 7#a7 9 p>agraph 7#b77;,a71 by /rik+ p>agraph 7#e7 & ins]t+ p>agraph 7#d72 & 7#b7 9 p>agraph 7#g77;,a7-- 7,a7 by /rik+ an orig9al new drug application & ins]t+ a new drug application ea* place x appe>s2 7,b7 9 clause 7i71 by /rik+ 7n includ+ any drug describ$ 9 p>agraph 7#e77 & ins]t+ 1 includ+ a drug product approv$ = m>ket+ z a non-prescription drug t is reg>d$ z a cov]$ outpati5t drug "u p>agraph 7#d712 7,c7 9 clause 7ii7-- 7i7 by /rik+ 0 orig9ally m>ket$ & ins]t+ is m>ket$2 & 7ii7 by ins]t+ 1 unless ! ,secret>y det]m9es t a n>r[ exception applies 7z describ$ 9 section #ddg4ejb ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation77 be=e ! p]iod2 & 7,d7 9 clause 7iv7-- 7i7 by ins]t+ 1 includ+ a drug product approv$ = m>ket+ z a non-prescription drug t is reg>d$ z a cov]$ outpati5t drug "u p>agraph 7#d71 aft] cov]$ outpati5t drug2 7ii7 by ins]t+ unless ! ,secret>y det]m9es t a n>r[ exception applies 7z describ$ 9 section #ddg4ejb ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation77 aft] "u ! new drug application2 & 7iii7 by add+ at ! end ! foll[+ new s5t5ce3 ,su* t]m also includes a cov]$ outpati5t drug t is a biological product lic5s$1 produc$1 or di/ribut$ "u a biologics lic5se application approv$ by ! ,food & ,drug ,adm9i/ration44 7d7 ,exclusion ( manufactur]s = kn[+ misclassification ( cov]$ outpati5t drugs ,section #aabh7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g7;b77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#ag7 ,kn[+ly misclassify+ cov]$ outpati5t drugs ,any manufactur] or (fic]1 director1 ag5t1 or manag+ employee ( su* manufactur] t kn[+ly misclassifies a cov]$ outpati5t drug "u an agreem5t "u section #aibg1 kn[+ly fails to correct su* misclassification1 or kn[+ly provides false in=mation relat$ to drug pric+1 drug product in=mation1 or data relat$ to drug pric+ or drug product in=mation4 4 7e7 ,effective date ,! am5dm5ts made by ?is section %all take effect on ! date ( ! enactm5t ( ?is ,act1 & %all apply to cov]$ outpati5t drugs suppli$ by manufactur]s "u agreem5ts "u section #aibg ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7 on or aft] su* date4 #g4 ,ext5sion ( ?ird-p>ty liability p]iod = *ild support s]vices 7a7 ,9 g5]al ,section #bjb7;a77#b7 ( ! ,bip>tisan ,budget ,act ( #bjac 7,public ,law #aac-fg7 is am5d$ by /rik+ #ij days & ins]t+ #ajj days4 7b7 ,effective date ,! am5dm5t made by ?is section %all take effect on ! date ( ! enactm5t ( ?is ,act4 #h4 ,d5ial ( ,,ffp = c]ta9 exp5ditures relat+ to vacuum erection sy/ems & p5ile pro/hetic implants 7a7 ,9 g5]al ,section #aijc7;i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7i77 is am5d$ by ins]t+ aft] p>agraph 7#aa7 ! foll[+3 7#ab7 ) respect to any am\nts exp5d$ =-- 7,a7 a vacuum erection sy/em t is n m$ically necess>y2 or 7,b7 ! ins]tion1 repair1 or removal & replacem5t ( a p5ile pro/hetic implant 7unless su* ins]tion1 repair1 or removal & replacem5t is m$ically necess>y72 or 4 7b7 ,effective date ,! am5dm5t made by subsection 7a7 %all apply ) respect to items & s]vices furni%$ on or aft] ,janu>y #a1 #bjbj4 #i4 ,det]m9ation ( ,budget>y ,effects ,! budget>y effects ( ?is ,act1 = ! purpose ( comply+ ) ! ,/atutory ,pay-,z-,y-,g ,act ( #bjaj1 %all be det]m9$ by ref]5ce to ! late/ /atem5t titl$ ,budget>y ,effects ( ,,paygo ,legislation = ?is ,act1 submitt$ = pr9t+ 9 ! ,congressional ,record by ! ,*airman ( ! ,h\se ,budget ,committee1 provid$ t su* /atem5t has be5 submitt$ prior to ! vote on passage4 ,pass$ ! ,h\se ( ,repres5tatives ,m>* #be1 #bjai4;,*]yl ,l4 ,johnson1,cl]k