,,ii #aai? ,,congress #a/ ,session ,s4 #hia ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,m>* #f1 #bjbe,mr4 ,wyd5 7= himself & ,mr4 ,s&]s7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,f9ance ,a ,,bill ,to ext5d expir+ heal? provisions & improve heal? c>e deliv]y4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,bip>tisan ,heal? ,c>e ,act4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4,,title ,i--,medicaid,sec4 #aja4 ,/reaml9$ enrollm5t process = eligible out-(-/ate provid]s "u ,m$icaid & ,,*ip4,sec4 #ajb4 ,mak+ c]ta9 adju/m5ts to cov]age ( home or community-bas$ s]vices "u ,m$icaid4,sec4 #ajc4 ,remov+ c]ta9 age re/rictions on ,m$icaid eligibility = work+ adults ) disabilities4,sec4 #ajd4 ,m$icaid ,/ate plan requirem5t = det]m9+ resid5cy & cov]age = milit>y families4,sec4 #aje4 ,ensur+ ! reliability ( address in=mation provid$ "u ! ,m$icaid program4,sec4 #ajf4 ,codify+ c]ta9 ,m$icaid provid] scre5+ requirem5ts relat$ to deceas$ provid]s4,sec4 #ajg4 ,modify+ c]ta9 ,/ate requirem5ts = ensur+ deceas$ individuals d n rema9 enroll$4,sec4 #ajh4 ,"o-ye> delay ( ,m$icaid & ,,*ip requirem5ts = heal? scre5+s1 ref]rals1 & case managem5t s]vices = eligible juv5iles 9 public in/itutions2 ,/ate int]im "w plans4,sec4 #aji4 ,/ate /udies & ,,hhs report on co/s ( provid+ mat]nity1 labor1 & deliv]y s]vices4,sec4 #aaj4 ,modify+ c]ta9 disproportionate %>e hospital allotm5ts4,sec4 #aaa4 ,modify+ c]ta9 limitations on disproportionate %>e hospital paym5t adju/m5ts "u ! ,m$icaid program4,sec4 #aab4 ,ensur+ accurate paym5ts to ph>macies "u ,m$icaid4,sec4 #aac4 ,prev5t+ ! use ( abusive spread pric+ 9 ,m$icaid4,,title ,,ii--,medicare,sec4 #bja4 ,ext5sion ( increas$ inpati5t hospital paym5t adju/m5t = c]ta9 l[-volume hospitals4,sec4 #bjb4 ,ext5sion ( ! ,m$ic>e-dep5d5t hospital 7,,mdh7 program4,sec4 #bjc4 ,ext5sion ( add-on paym5ts = ambulance s]vices4,sec4 #bjd4 ,ext5d+ inc5tive paym5ts = p>ticipation 9 eligible alt]native paym5t models4,sec4 #bje4 ,tempor>y paym5t increase "u ! ,m$ic>e physician fee s*$ule to acc\nt = exceptional circum/ances4,sec4 #bjf4 ,ext5sion ( fund+ = quality measure endorsem5t1 input1 & selection4,sec4 #bjg4 ,ext5sion ( fund+ outrea* & assi/ance = l[-income programs4,sec4 #bjh4 ,ext5sion ( ! "w geographic index floor4,sec4 #bji4 ,ext5sion ( c]ta9 teleheal? flexibilities4,sec4 #baj4 ,requir+ modifi] = use ( teleheal? to conduct face-to-face enc\nt] prior to rec]tification ( eligibility = hospice c>e4,sec4 #baa4 ,ext5d+ acute hospital c>e at home waiv] flexibilities4,sec4 #bab4 ,enhanc+ c]ta9 program integrity requirem5ts = ,,dme "u ,m$ic>e4,sec4 #bac4 ,guidance on furni%+ s]vices via teleheal? to individuals ) limit$ ,engli% pr(ici5cy4,sec4 #bad4 ,9-home c>diopulmon>y rehabilitation flexibilities4,sec4 #bae4 ,inclusion ( virtual diabetes prev5tion program suppli]s 9 ,,mdpp ,exp&$ ,model4,sec4 #baf4 ,m$ication-induc$ movem5t disord] outrea* & education4,sec4 #bag4 ,report on we>able m$ical devices4,sec4 #bah4 ,ext5sion ( tempor>y inclusion ( au?oriz$ oral antiviral drugs z cov]$ "p ,d drugs4,sec4 #bai4 ,ext5sion ( adju/m5t to calculation ( hospice cap am\nt4,sec4 #bbj4 ,multiye> contract+ au?ority = ,med,p,a,c & ,,macpac4,sec4 #bba4 ,contract+ p>ity = ,med,p,a,c & ,,macpac4,sec4 #bbb4 ,adju/m5ts to ,m$ic>e "p ,d co/-%>+ r$uctions = l[-income individuals4,sec4 #bbc4 ,requir+ ,enhanc$ & ,accurate ,li/s ( 7,,real7 ,heal? ,provid]s ,act4,sec4 #bbd4 ,m$ic>e cov]age ( multi-canc] e>ly detection scre5+ te/s4,sec4 #bbe4 ,m$ic>e cov]age ( ext]nal infusion pumps & non-self-adm9i/rable home infusion drugs4,sec4 #bbf4 ,assur+ ph>macy access & *oice = ,m$ic>e b5efici>ies4,sec4 #bbg4 ,mod]niz+ & ,ensur+ ,,pbm ,acc\ntability4,sec4 #bbh4 ,requir+ a sep>ate id5tification numb] & an atte/ation = ea* (f-campus outpati5t dep>tm5t ( a provid]4,sec4 #bbi4 ,m$ic>e seque/ration4,sec4 #bcj4 ,m$ic>e improvem5t fund4,,title ,,iii--,human ,services,sec4 #cja4 ,sexual risk avoidance education ext5sion4,sec4 #cjb4 ,p]sonal responsibility education ext5sion4,sec4 #cjc4 ,ext5sion ( fund+ = family-to-family heal? in=mation c5t]s4,,title ,,iv--,public heal? extenders,subtitle ,a--,extensions,sec4 #dja4 ,ext5sion = community heal? c5t]s1 ,national ,heal? ,s]vice ,corps1 & tea*+ heal? c5t]s t op]ate ,,gme programs4,sec4 #djb4 ,ext5sion ( special diabetes programs4,subtitle ,b--,_w ,trade ,c5t] ,heal? ,program,sec4 #daa4 #i_/aa respond] & survivor heal? fund+ corrections4,,title ,v--,,support ,act ,reauthorization,sec4 #eja4 ,%ort title4,subtitle ,a--,prevention,sec4 #eaa4 ,pr5atal & po/natal heal?4,sec4 #eab4 ,monitor+ & education reg>d+ infections associat$ ) illicit drug use & o!r risk factors4,sec4 #eac4 ,prev5t+ ov]doses ( controll$ sub/ances4,sec4 #ead4 ,support = individuals & families impact$ by fetal alcohol spectrum disord]4,sec4 #eae4 ,promot+ ,/ate *oice 9 ,,pdmp sy/ems4,sec4 #eaf4 ,fir/ respond] tra9+ program4,sec4 #eag4 ,donald ,j4 ,coh5 ,national ,*ild ,traumatic ,/ress ,initiative4,sec4 #eah4 ,protect+ suicide prev5tion lifel9e f cyb]security incid5ts4,sec4 #eai4 ,bruce's law4,sec4 #ebj4 ,guidance on at-home drug disposal sy/ems4,sec4 #eba4 ,assessm5t ( opioid drugs & actions4,sec4 #ebb4 ,grant program = ,/ate & ,tribal response to opioid use disord]s4,subtitle ,b--,treatment,sec4 #eca4 ,resid5tial treatm5t program = pregnant & po/p>tum wom54,sec4 #ecb4 ,improv+ access to addiction m$ic9e provid]s4,sec4 #ecc4 ,m5tal & behavioral heal? education & tra9+ grants4,sec4 #ecd4 ,loan repaym5t program = sub/ance use disord] treatm5t work=ce4,sec4 #ece4 ,developm5t & dissem9ation ( model tra9+ programs = sub/ance use disord] pati5t records4,sec4 #ecf4 ,task =ce on be/ practices = trauma-in=m$ id5tification1 ref]ral1 & support4,sec4 #ecg4 ,grants to enhance access to sub/ance use disord] treatm5t4,sec4 #ech4 ,/ate guidance relat$ to individuals ) s]i\s m5tal illness & *ildr5 ) s]i\s emotional di/urbance4,sec4 #eci4 ,review+ ! s*$ul+ ( approv$ products conta9+ a comb9ation ( bupr5orph9e & naloxone4,subtitle ,c--,recovery,sec4 #eda4 ,build+ communities ( recov]y4,sec4 #edb4 ,pe] support te*nical assi/ance c5t]4,sec4 #edc4 ,compreh5sive opioid recov]y c5t]s4,sec4 #edd4 ,y\? prev5tion & recov]y4,sec4 #ede4 ,,c>e] ,act4,sec4 #edf4 ,address+ economic & work=ce impacts ( ! opioid crisis4,subtitle ,d--,miscellane\s matters,sec4 #eea4 ,deliv]y ( a controll$ sub/ance by a ph>macy to a prescrib+ practition]4,sec4 #eeb4 ,te*nical correction on controll$ sub/ances disp5s+4,sec4 #eec4 ,requir$ tra9+ = prescrib]s ( controll$ sub/ances4,sec4 #eed4 ,ext5sion ( tempor>y ord] = f5tanyl-relat$ sub/ances4,,title ,,vi--,p&emic & ,all-,haz>ds ,prep>$ness & ,response,sec4 #fja4 ,%ort title4,subtitle ,a--,/ate & local read9ess & response,sec4 #faa4 ,tempor>y reassignm5t ( ,/ate & local p]sonnel dur+ a public heal? em]g5cy4,sec4 #fab4 ,public ,heal? ,em]g5cy ,prep>$ness program4,sec4 #fac4 ,hospital ,prep>$ness ,program4,sec4 #fad4 ,facilities & capacities ( ! ,c5t]s = ,disease ,control & ,prev5tion to combat public heal? security ?reats4,sec4 #fae4 ,pilot program to support ,/ate m$ical /ockpiles4,sec4 #faf4 ,enhanc+ dome/ic wa/ewat] surveillance = pa?og5 detection4,sec4 #fag4 ,reau?orization ( ,mosquito ,abatem5t = ,safety & ,heal? program4,subtitle ,b--,f$]al plann+ & coordination,sec4 #fba4 ,all-,haz>ds ,em]g5cy ,prep>$ness & ,response4,sec4 #fbb4 ,national ,heal? ,security ,/rategy4,sec4 #fbc4 ,improv+ developm5t & di/ribution ( diagno/ic te/s4,sec4 #fbd4 ,combat+ antimicrobial resi/ance4,sec4 #fbe4 ,/rategic ,national ,/ockpile & mat]ial ?reats4,sec4 #fbf4 ,m$ical c\nt]measures = viral ?reats ) p&emic pot5tial4,sec4 #fbg4 ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measures ,ent]prise4,sec4 #fbh4 ,fell[%ip & tra9+ programs4,sec4 #fbi4 ,regional bioconta9m5t rese>* laboratories4,sec4 #fbi;,a4 ,limitation relat$ to c\ntries ( conc]n conduct+ c]ta9 rese>*4,subtitle ,c--,address+ ! ne$s ( all individuals,sec4 #fca4 ,improv+ access to c]ta9 programs4,sec4 #fcb4 ,support+ at-risk individuals dur+ em]g5cy responses4,sec4 #fcc4 ,national advisory committees4,sec4 #fcd4 ,national ,academies /udy on prizes4,subtitle ,d--,additional reauthorizations,sec4 #fda4 ,m$ical c\nt]measure priority review v\*]4,sec4 #fdb4 ,epidemic ,intellig5ce ,s]vice4,sec4 #fdc4 ,monitor+ & di/ribution ( c]ta9 m$ical c\nt]measures4,sec4 #fdd4 ,regional heal? c>e em]g5cy prep>$ness & response sy/ems4,sec4 #fde4 ,em]g5cy sy/em = advance regi/ration ( volunte] heal? pr(essionals4,sec4 #fdf4 ,ensur+ collaboration & coord9ation 9 m$ical c\nt]measure developm5t4,sec4 #fdg4 ,milit>y & civilian p>tn]%ip = trauma read9ess4,sec4 #fdh4 ,national ,disa/] ,m$ical ,sy/em4,sec4 #fdi4 ,volunte] ,m$ical ,res]ve ,corps4,sec4 #fdi;,a4 ,epidemiology-laboratory capacity4,,title ,,vii--,public ,heal? ,programs,sec4 #gja4 ,action = d5tal heal?4,sec4 #gjb4 ,,preemie4,sec4 #gjc4 ,prev5t+ mat]nal dea?s4,sec4 #gjd4 ,sickle cell disease prev5tion & treatm5t4,sec4 #gje4 ,traumatic bra9 injuries4,sec4 #gjf4 ,lifespan respite c>e4,sec4 #gjg4 ,dr4 ,lorna ,bre5 heal? c>e provid] protection4,sec4 #gjh4 ,,scre5s = ,canc]4,sec4 #gji4 ,de,ondra ,dixon ,,include ,project4,sec4 #gaj4 ,,improve ,initiative4,sec4 #gaa4 ,organ ,procurem5t & ,transplantation ,network4,sec4 #gab4 ,honor ,our ,liv+ ,donors4,sec4 #gac4 ,program = p$iatric /udies ( drugs4,,title ,,viii--,food & ,drug ,administration,subtitle ,a--,give ,kids a ,*ance ,sec4 #hja4 ,rese>* into p$iatric uses ( drugs2 additional au?orities ( ,food & ,drug ,adm9i/ration reg>d+ molecul>ly t>get$ canc] drugs4,sec4 #hjb4 ,ensur+ completion ( p$iatric /udy requirem5ts4,sec4 #hjc4 ,,fda report on ,,prea en=cem5t4,sec4 #hjd4 ,ext5sion ( au?ority to issue priority review v\*]s to enc\rage treatm5ts = r>e p$iatric diseases4,sec4 #hje4 ,limitations on exclusive approval or lic5sure ( orphan drugs4,subtitle ,b--,unit$ ,/ates-,abraham ,accords ,coop]ation & ,security,sec4 #haa4 ,e/abli%m5t ( ,abraham ,accords ,(fice )9 ,food & ,drug ,adm9i/ration4,,title ,,ix--,l[]+ prescription drug costs,sec4 #ija4 ,ov]sight ( ph>macy b5efit managem5t s]vices4,sec4 #ijb4 ,full rebate pass ?r\gh to plan2 exception = innoc5t plan fiduci>ies4,sec4 #ijc4 ,increas+ transp>5cy 9 g5]ic drug applications4,sec4 #ijd4 ,title #ce am5dm5ts4,,title ,x--,miscellaneous,sec4 #ajja4 ,ext5sion ( safe h>bor = abs5ce ( d$uctible = teleheal?4 ,i ,m$icaid #aja4 ,/reaml9$ enrollm5t process = eligible out-(-/ate provid]s "u ,m$icaid & ,,*ip 7a7 ,9 g5]al ,section #aijb7kk7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7kk77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#aj7 ,/reaml9$ enrollm5t process = eligible out-(-/ate provid]s 7,a7 ,9 g5]al ,! ,/ate-- 7i7 adopts & implem5ts a process to all[ an eligible out-(-,/ate provid] to enroll "u ! ,/ate plan 7or a waiv] ( su* plan7 to furni% items & s]vices to1 or ord]1 prescribe1 ref]1 or c]tify eligibility = items & s]vices =1 qualify+ individuals )\t ! imposition ( scre5+ or enrollm5t requirem5ts by su* ,/ate t exce$ ! m9imum necess>y = su* ,/ate to provide paym5t to an eligible out-(-,/ate provid] "u su* ,/ate plan 7or a waiv] ( su* plan71 su* z ! provid]'s "n & ,national ,provid] ,id5tifi] 7& su* o!r in=mation specifi$ by ! ,secret>y72 & 7ii7 provides t an eligible out-(-,/ate provid] t enrolls z a p>ticipat+ provid] 9 ! ,/ate plan 7or a waiv] ( su* plan7 ?r\gh su* process %all be s enroll$ = a #e-ye> p]iod1 unless ! provid] is t]m9at$ or exclud$ f p>ticipation dur+ su* p]iod4 7,b7 ,def9itions ,9 ?is p>agraph3 7i7 ,eligible out-(-/ate provid] ,! t]m eligible out-(-,/ate provid] means1 ) respect to a ,/ate1 a provid]-- 7,i7 t is locat$ 9 any o!r ,/ate2 7,,ii7 t-- 7aa7 0 det]m9$ by ! ,secret>y to h a limit$ risk ( fraud1 wa/e1 & abuse = purposes ( det]m9+ ! level ( scre5+ to be conduct$ "u section #ahff7;j77#b71 has be5 s scre5$ "u su* section #ahff7;j77#b71 & is enroll$ 9 ! ,m$ic>e program "u title ,,xviii2 or 7bb7 0 det]m9$ by ! ,/ate ag5cy adm9i/]+ or sup]vis+ ! adm9i/ration ( ! ,/ate plan 7or a waiv] ( su* plan7 ( su* o!r ,/ate to h a limit$ risk ( fraud1 wa/e1 & abuse = purposes ( det]m9+ ! level ( scre5+ to be conduct$ "u p>agraph 7#a7 ( ?is subsection1 has be5 s scre5$ "u su* p>agraph 7#a71 & is enroll$ "u su* ,/ate plan 7or a waiv] ( su* plan72 & 7,,iii7 t has n be5-- 7aa7 exclud$ f p>ticipation 9 any ,f$]al heal? c>e program pursuant to section #aabh or #aabh;,a2 7bb7 exclud$ f p>ticipation 9 ! ,/ate plan 7or a waiv] ( su* plan7 pursuant to "p #ajjb ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation71 or ,/ate law2 or 7cc7 t]m9at$ f p>ticipat+ 9 a ,f$]al heal? c>e program or ! ,/ate plan 7or a waiv] ( su* plan7 = a reason describ$ 9 p>agraph 7#h77;,a74 7ii7 ,qualify+ individual ,! t]m qualify+ individual means an individual "u #ba ye>s ( age :o is enroll$ "u ! ,/ate plan 7or waiv] ( su* plan74 7iii7 ,/ate ,! t]m ,/ate means #a ( ! #ej ,/ates or ! ,di/rict ( ,columbia4 4 7b7 ,con=m+ am5dm5ts 7#a7 ,section #aijb7;a77#gg7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#gg77 is am5d$ by ins]t+ enrollm5t1 aft] scre5+14 7#b7 ,! subsection head+ = section #aijb7kk7 ( su* ,act 7#db ,u4,s4,c4 #acif;a7kk77 is am5d$ by ins]t+ enrollm5t1 aft] scre5+14 7#c7 ,section #bajg7;e77#a77;,g7 ( su* ,act 7#db ,u4,s4,c4 #acig;gg7e77#a77;,g77 is am5d$ by ins]t+ enrollm5t1 aft] scre5+14 7c7 ,effective date ,! am5dm5ts made by ?is section %all take effect on ! date t is #c ye>s aft] ! date ( enactm5t ( ?is ,act4 #ajb4 ,mak+ c]ta9 adju/m5ts to cov]age ( home or community-bas$ s]vices "u ,m$icaid 7a7 ,increas+ transp>5cy ( ,,hcbs cov]age "u ,m$icaid 7#a7 ,9 g5]al ,section #aiae7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifn7c77 is am5d$-- 7,a7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,e7-- 7,i7 by ins]t+ 1 n less frequ5tly ?an be=e annually2 & 7,,ii7 by ins]t+ 7includ+1 ) respect to su* in=mation provid$ on or aft] ,july #i1 #bjbg1 ! in=mation specifi$ 9 p>agraph 7#aa77 be=e ! p]iod at ! end2 & 7ii7 by add+ at ! end ! foll[+ flu% s5t5ce3 ,! ,secret>y %all make all in=mation provid$ "u subp>agraph 7,e7 on or aft] ! date ( ! enactm5t ( ?is s5t5ce publicly available on ! website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 2 & 7,b7 by add+ at ! end ! foll[+ new p>agraph3 7#aa7 ,= purposes ( p>agraph 7#b77;,e71 ! in=mation specifi$ 9 ?is p>agraph is ! foll[+3 7,a7 ,9 ! case ( a ,/ate t limits ! numb] ( individuals :o may be provid$ home or community-bas$ s]vices "u a waiv] grant$ "u ?is subsection & ma9ta9s a li/ ( individuals wait+ to enroll 9 su* waiv]1 a description ( h[ ! ,/ate ma9ta9s su* li/1 includ+-- 7i7 in=mation on :e!r ! ,/ate scre5s individuals on su* li/ to det]m9e :e!r su* individuals are eligible to receive su* s]vices "u su* waiv]2 7ii7 in=mation on :e!r 7&1 if applicable1 h[ (t57 ! ,/ate p]iodically re-scre5s individuals on su* li/ = eligibility2 7iii7 ! numb] ( p on su* li/ ( individuals wait+ to enroll 9 su* waiv]2 & 7iv7 ! av]age am\nt ( "t t individuals newly enroll$ 9 su* waiv] )9 ! pa/ #ab mon?s 7 on su* li/ ( individuals wait+ to enroll 9 su* waiv]4 7,b7 ,) respect to homemak] s]vices1 home heal? aide s]vices1 p]sonal c>e s]vices1 & habilitation s]vices furni%$ "u waiv]s "u ?is subsection1 by ea* su* s]vice type-- 7i7 = individuals newly receiv+ su* s]vices )9 ! pa/ #ab mon?s1 ! av]age am\nt ( "t 7:i* may be det]m9$ us+ /ati/ically valid r&om sampl+ ( su* individuals7 f :5 su* s]vices are initially approv$ = su* an individual to :5 su* individual beg9s receiv+ su* s]vices2 & 7ii7 ! p]c5tage ( au?oriz$ h\rs 7:i* may be det]m9$ us+ /ati/ically valid r&om sampl+ ( individuals au?oriz$ to receive su* s]vices7 t are provid$ )9 ! pa/ #ab mon?s4 4 7#b7 ,con=m+ am5dm5ts ,section #aiae ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifn7 is am5d$-- 7,a7 9 subsection 7i7 by add+ at ! end ! foll[+ new p>agraph3 7#h7 ,report+ requirem5t ,) respect to homemak] s]vices1 home heal? aide s]vices1 p]sonal c>e s]vices1 & habilitation s]vices provid$ "u ?is subsection on or aft] ,july #i1 #bjbg1 ! ,/ate1 n less frequ5tly ?an annually1 %all provide to ! ,secret>y ! same in=mation reg>d+ su* s]vices z ! ,/ate is requir$ to provide "u subsection 7c77#aa77;,b74 2 7,b7 9 subsection 7j77#b77;,e71 by ins]t+ aft] ! second s5t5ce ! foll[+3 ,) respect to any homemak] s]vices1 home heal? aide s]vices1 p]sonal c>e s]vices1 & habilitation s]vices provid$ "u ?is subsection on or aft] ,july #i1 #bjbg1 ! ,/ate1 n less frequ5tly ?an annually1 %all provide to ! ,secret>y ! same in=mation reg>d+ su* s]vices z ! ,/ate is requir$ to provide "u subsection 7c77#aa77;,b742 & 7,c7 9 subsection 7k77#c77;,e7-- 7i7 by /rik+ & aft] ! co/ ( su* s]vices & supports12 & 7ii7 by ins]t+ be=e ! p]iod1 ! foll[+3 1 & ) respect to homemak] s]vices1 home heal? aide s]vices1 p]sonal c>e s]vices1 & habilitation s]vices provid$ "u ?is subsection on or aft] ,july #i1 #bjbg1 n less frequ5tly ?an annually1 ! same in=mation reg>d+ su* s]vices z ! ,/ate is requir$ to provide "u subsection 7c77#aa77;,b74 7b7 ,demon/ration program ,to exp& ,,hcbs cov]age "u section #aiae7;c7 waiv]s ,section #aiae7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifn7c771 z am5d$ by subsection 7a71 is fur!r am5d$-- 7#a7 9 p>agraph 7#b77;,e71 by ins]t+ 1 & ! in=mation specifi$ 9 p>agraph 7#ab77;,c77v71 :5 applicable aft] p>agraph 7#aa72 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#ab7 ,demon/ration program to exp& cov]age = home or community-bas$ s]vices 7,a7 ,9 g5]al 7i7 ,approval ,n lat] ?an #bd mon?s aft] ! date on :i* ! plann+ grants "u subp>agraph 7,b7 are aw>d$1 not)/&+ p>agraph 7#a71 ! ,secret>y may approve a waiv] t is /&alone f any o!r waiv] approv$ "u ?is subsection = n m ?an #e ,/ates1 select$ 9 accordance ) clause 7ii71 to include z m$ical assi/ance "u ! ,/ate plan ( su* ,/ate1 = ! #c-ye> p]iod beg9n+ on ! date ( su* approval1 paym5t = "p or all ( ! co/ ( home or community-bas$ s]vices 7o!r ?an room & bo>d 7z describ$ 9 p>agraph 7#a777 approv$ by ! ,secret>y :i* are provid$ pursuant to a writt5 plan ( c>e to individuals describ$ 9 subp>agraph 7,c77iii74 7ii7 ,selection crit]ia ,9 select+ ,/ates = purposes ( clause 7i71 ! ,secret>y %all-- 7,i7 only select ,/ates t receiv$ a plann+ grant "u subp>agraph 7,b72 7,,ii7 only select ,/ates t meet ! requirem5ts specifi$ 9 subp>agraph 7,c7 & su* o!r requirem5ts z ! ,secret>y may det]m9e appropriate2 7,,iii7 select ,/ates 9 a mann] t ensures geographic div]sity2 7,,iv7 give pref]5ce to ,/ates ) a high] p]c5tage 7relative to o!r ,/ates t apply to be select$ = purposes ( clause 7i77 ( ! total ,/ate population resid+ 9 rural areas 7z det]m9$ by ! ,secret>y72 7,v7 give pref]5ce to ,/ates t h demon/rat$ m progress 9 rebalanc+ long-t]m s]vices & supports sy/ems "u ?is title1 z det]m9$ bas$ on ! relative %>e ( individuals :o use home or community-bas$ s]vices 7z def9$ by ! ,secret>y7 "u ?is title z a p]c5tage ( total individuals :o use long-t]m s]vices & supports 7z def9$ by ! ,secret>y7 "u ?is title 79 ! mo/ rec5t ye> = :i* su* data is available72 & 7,,vi7 give pref]5ce to ,/ates t pursue a waiv] "u ?is p>agraph t incorporates ! provision ( m5tal heal? s]vices = adults ) s]i\s m5tal illness1 *ildr5 ) s]i\s emotional di/urbances1 or individuals ) sub/ance use disord]4 7,b7 ,plann+ grants 7i7 ,9 g5]al 7,i7 ,approval ,n lat] ?an #ah mon?s aft] ! date ( ! enactm5t ( ?is p>agraph1 ! ,secret>y %all aw>d plann+ grants ( n m ?an #e1jjj1jjj ea* to n m ?an #aj ,/ates = purposes ( prep>+ to submit a reque/ = a waiv] "u ?is subsection 7includ+ = co/s to implem5t ! waiv] or o!r activities to exp& ! provision ( home or community-bas$ s]vices "u ?is section7 to provide home or community-bas$ s]vices to individuals describ$ 9 subp>agraph 7,c77iii74 7,,ii7 ,selection crit]ia ,9 aw>d+ plann+ grants "u subclause 7,i71 ! ,secret>y %all use ! selection crit]ia specifi$ 9 subclauses 7,,iii7 ?r\gh 7,,vi7 ( subp>agraph 7,a77ii74 7ii7 ,consultation ,a ,/ate t is aw>d$ a plann+ grant "u clause 7i7 %all1 9 prep>+ to submit a reque/ = a waiv] describ$ 9 su* clause1 consult )-- 7,i7 individuals 9 ne$ ( 7& n receiv+7 home or community-bas$ s]vices1 individuals receiv+ home or community-bas$ s]vices1 & ! c>egiv]s ( su* individuals2 7,,ii7 provid]s furni%+ home or community-bas$ s]vices2 & 7,,iii7 su* o!r /akehold]s1 z ! ,secret>y may specify4 7,c7 ,/ate requirem5ts ,9 addition to ! requirem5ts specifi$ "u ?is subsection 7except = ! requirem5ts describ$ 9 subp>agraphs 7,c7 & 7,d7 ( p>agraph 7#b7 & any o!r requirem5t ! ,secret>y det]m9es to be inapplicable 9 ! context ( a waiv] relation to individuals :o d n require ! level ( c>e describ$ 9 p>agraph 7#a771 ! requirem5ts specifi$ 9 ?is p>agraph are1 ) respect to a ,/ate1 ! foll[+3 7i7 ,z ( ! date t su* ,/ate reque/s a waiv] "u ?is subsection to provide home or community-bas$ s]vices to individuals describ$ 9 clause 7iii71 all o!r waiv]s 7if any7 grant$ "u ?is subsection to su* ,/ate meet ! requirem5ts ( ?is subsection4 7ii7 ,! ,/ate demon/rates to ! ,secret>y t approval ( a waiv] "u ?is subsection ) respect to individuals describ$ 9 clause 7iii7 w n result 9 a mat]ial increase ( ! av]age am\nt ( "t t individuals ) respect to :om a det]m9ation describ$ 9 p>agraph 7#a7 has be5 made w ne$ to wait to receive home or community-bas$ s]vices "u any waiv] grant$ "u ?is subsection1 z det]m9$ by ! ,secret>y4 7iii7 ,! ,/ate e/abli%es ne$s-bas$ crit]ia1 subject to ! approval ( ! ,secret>y1 to id5tify individuals = :om a det]m9ation describ$ 9 p>agraph 7#a7 is n applicable1 :o w be eligible = home or community-bas$ s]vices "u a waiv] approv$ "u ?is p>agraph1 & specifies ! home or community-bas$ s]vices su* individuals s eligible w receive4 7iv7 ,! ,/ate e/abli%$ ne$s-bas$ crit]ia = det]m9+ :e!r an individual describ$ 9 clause 7iii7 requires ! level ( c>e provid$ 9 a hospital1 nurs+ facility1 or an int]m$iate c>e facility = individuals ) developm5tal disabilities "u ! ,/ate plan or "u any waiv] ( su* plan t are m /r+5t ?an ! ne$s-bas$ crit]ia e/abli%$ "u clause 7iii7 = det]m9+ eligibility = home or community-bas$ s]vices4 7v7 ,! ,/ate atte/s t ! ,/ate's av]age p] capita exp5diture = m$ical assi/ance "u ! ,/ate plan 7or waiv] ( su* plan7 provid$ ) respect to su* individuals enroll$ 9 a waiv] "u ?is p>agraph w n exce$ ! ,/ate's av]age p] capita exp5ditures = m$ical assi/ance = individuals receiv+ in/itutional c>e "u ! ,/ate plan 7or waiv] ( su* plan7 = ! duration t ! waiv] "u ?is p>agraph is 9 effect4 7vi7 ,! ,/ate provides to ! ,secret>y data 79 su* =m & mann] z ! ,secret>y may specify7 reg>d+ ! numb] ( individuals describ$ 9 clause 7i7 ) respect to a ,/ate seek+ approval ( a waiv] "u ?is subsection1 to :om ! ,/ate w make su* s]vices available "u su* waiv]4 7vii7 ,! ,/ate agrees to provide to ! ,secret>y1 n less frequ5tly ?an annually1 data = purposes ( p>agraph 7#b77;,e7 79 su* =m & mann] z ! ,secret>y may specify7 reg>d+1 ) respect to ea* prec$+ ye> 9 :i* a waiv] "u ?is subsection to provide home & community-bas$ s]vices to individuals describ$ 9 clause 7iii7 0 9 effect-- 7,i7 ! co/ 7z su* t]m is def9$ by ! ,secret>y7 ( su* s]vices furni%$ to individuals describ$ 9 clause 7iii71 brok5 d[n by type ( s]vice2 7,,ii7 ) respect to ea* type ( home & community-bas$ s]vice provid$ "u ! waiv]1 ! l5g? ( "t t su* individuals h receiv$ su* s]vice2 7,,iii7 a comp>ison betwe5 ! data describ$ 9 subclause 7,i7 & any comp>able data available ) respect to individuals ) respect to :om a det]m9ation describ$ 9 p>agraph 7#a7 has be5 made & ) respect to individuals receiv+ in/itutional c>e "u ?is title2 & 7,,iv7 ! numb] ( individuals :o h receiv$ home & community-bas$ s]vices "u ! waiv] dur+ ! prec$+ ye>4 4 7c7 ,non-,application ( ! ,pap]work ,r$uction ,act ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code 7commonly ref]r$ to z ! 8,pap]work ,r$uction ,act ( #aiie071 %all n apply to ! implem5tation ( ! am5dm5ts made by subsections 7a7 & 7b74 7d7 ,,cms guidance to ,/ates on int]im cov]age "u section #aiae home & community-,bas$ s]vices au?orities ,n lat] ?an ,janu>y #a1 #bjbg1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue guidance to ! ,/ates to cl>ify h[ a ,/ate may provide1 ) respect to an individual :o is eligible = home & community-bas$ s]vices "u section #aiae ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifn71 cov]age ( su* s]vices pursuant to a provisional writt5 plan ( c>e1 p5d+ f9alization1 ) respect to su* individual4 7e7 ,fund+ 7#a7 ,9 g5]al ,!re are appropriat$1 out ( any funds 9 ! ,treasury n o!rwise obligat$1 #ga1jjj1jjj = fiscal ye> #bjbe1 to rema9 available until exp5d$1 to ! ,secret>y ( ,heal? & ,human ,s]vices = purposes ( c>ry+ out subsection 7d7 & ! am5dm5ts made by subsection 7b74 7#b7 ,res]vation = plann+ grants ,( ! am\nt appropriat$ "u p>agraph 7#a71 ! ,secret>y ( ,heal? & ,human ,s]vices %all res]ve #ej1jjj1jjj ( su* am\nt to aw>d plann+ grants "u ! demon/ration program e/abli%$ by ! am5dm5ts made by subsection 7b74 #ajc4 ,remov+ c]ta9 age re/rictions on ,m$icaid eligibility = work+ adults ) disabilities 7a7 ,modification ( optional buy-,9 gr\ps 7#a7 ,9 g5]al ,section #aijb7;a77#aj77;,a77ii77,,xv7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#aj77;,a77ii77,,xv77 is am5d$ by /rik+ b less ?an #fe14 7#b7 ,def9ition modification ,section #aije7v77#a77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7v77#a77;,a77 is am5d$ by /rik+ 1 b less ?an #fe14 7b7 ,application to c]ta9 ,/ates ,a ,/ate t1 z ( ! date ( enactm5t ( ?is ,act1 provides = mak+ m$ical assi/ance available to individuals describ$ 9 subclause 7,,xv7 or 7,,xvi7 ( section #aijb7;a77#aj77;,a77ii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#aj77;,a77ii77 %all n be reg>d$ z fail+ to comply ) ! requirem5ts ( ei!r su* subclause 7z am5d$ by subsection 7a77#a77 or ) section #aije7v77#a77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7v77#a77;,a77 7z am5d$ by subsection 7a77#b77 be=e ,janu>y #a1 #bjbg4 #ajd4 ,m$icaid ,/ate plan requirem5t = det]m9+ resid5cy & cov]age = milit>y families 7a7 ,9 g5]al ,section #aijb ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#hf71 by /rik+ & at ! end2 7,b7 9 p>agraph 7#hg71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,c7 by ins]t+ aft] p>agraph 7#hg71 ! foll[+ new p>agraph3 7#hh7 beg9n+ ,janu>y #a1 #bjbh1 provide1 ) respect to an active duty relocat$ individual 7z def9$ 9 subsection 7uu77#a77-- 7,a7 t1 = purposes ( det]m9+ eligibility = m$ical assi/ance "u ! ,/ate plan 7or waiv] ( su* plan71 su* active duty relocat$ individual is treat$ z a resid5t ( ! ,/ate unless su* individual volunt>ily elects n to be s treat$ = su* purposes2 7,b7 t if1 at ! "t ( relocation 7z describ$ 9 subsection 7uu77#a771 su* active duty relocat$ individual is on a home & community-bas$ s]vices wait+ li/ 7z def9$ 9 subsection 7uu77#b771 su* individual rema9s on su* li/ until-- 7i7 ! ,/ate completes an assessm5t & r5d]s a decision ) respect to ! eligibility ( su* individual to receive ! relevant home & community-bas$ s]vices at ! "t a slot = su* s]vices becomes available &1 9 ! case su* decision is a d5ial ( su* eligibility1 su* individual has exhau/$ ! individual's opportunity = a fair he>+2 or 7ii7 su* individual elects to be remov$ f su* li/2 & 7,c7 paym5t = m$ical assi/ance furni%$ "u ! ,/ate plan 7or a waiv] ( ! plan7 on behalf ( su* active duty relocat$ individual 9 ! milit>y s]vice relocation ,/ate 7z ref]r$ to 9 subsection 7uu77#a77;,b77i771 to ! ext5t t su* assi/ance is available 9 su* milit>y s]vice relocation ,/ate 9 accordance ) su* guidance z ! ,secret>y may issue to ensure access to su* assi/ance4 2 & 7#b7 by add+ at ! end ! foll[+ new subsection3 7uu7 ,active duty relocat$ individual2 home & community-,bas$ s]vices wait+ li/ ,= purposes ( subsection 7a77#hh7 & ?is subsection3 7#a7 ,active duty relocat$ individual ,! t]m active duty relocat$ individual means an individual-- 7,a7 :o-- 7i7 is enroll$ "u ! ,/ate plan 7or waiv] ( su* plan72 or 7ii7 ) respect to an individual describ$ 9 subp>agraph 7,c77ii71 w\ld be s enroll$ pursuant to subsection 7a77#aj77;,a77ii77,,vi7 if su* individual began receiv+ home & community-bas$ s]vices2 7,b7 :o-- 7i7 is a memb] ( ! ,arm$ ,=ces engag$ 9 active duty s]vice & is relocat$ to ano!r ,/ate 79 ?is subsection ref]r$ to z ! milit>y s]vice relocation ,/ate7 by reason ( su* s]vice2 7ii7 w\ld be describ$ 9 clause 7i7 except t ! individual /opp$ be+ engag$ 9 active duty s]vice 7includ+ by reason ( retirem5t f su* s]vice7 & ! la/ day on :i* ! individual 0 engag$ 9 active duty s]vice occurr$ n m ?an #ab mon?s ago2 or 7iii7 is a dep5d5t 7z def9$ by ! ,secret>y7 ( a memb] describ$ 9 clause 7i7 or 7ii7 :o relocates to ! milit>y s]vice relocation ,/ate ) su* memb]2 & 7,c7 :o-- 7i7 0 receiv+ home & community-bas$ s]vices 7z def9$ 9 section #ihag7;a77#b77;,b7 ( ! ,am]ican ,rescue ,plan ,act ( #bjba7 at ! "t ( su* relocation2 or 7ii7 if ! ,/ate ma9ta9s a home & community-bas$ s]vices wait+ li/1 0 on su* home & community-bas$ s]vices wait+ li/ at ! "t ( su* relocation4 7#b7 ,home & community-bas$ s]vices wait+ li/ ,! t]m home & community-bas$ s]vices wait+ li/ means1 9 ! case ( a ,/ate t has a limit on ! numb] ( individuals :o may receive home & community-bas$ s]vices "u section #aaae7;a71 section #aiae7;c71 or section #aiae7;j71 a li/ ma9ta9$ by su* ,/ate ( individuals :o are reque/+ to receive su* s]vices "u #a or m su* sections b = :om ! ,/ate has n yet complet$ an assessm5t & r5d]$ a decision ) respect to ! eligibility ( su* individuals to receive ! relevant home & community-bas$ s]vices at ! "t a slot = su* s]vices becomes available due to su* limit4 4 7b7 ,implem5tation fund+ ,!re are appropriat$1 out ( any funds 9 ! ,treasury n o!rwise obligat$1 #a1jjj1jjj = ea* ( fiscal ye>s #bjbe ?r\gh #bjbi1 to rema9 available until exp5d$1 to ! ,secret>y ( ,heal? & ,human ,s]vices = purposes ( implem5t+ ! am5dm5ts made by subsection 7a74 #aje4 ,ensur+ ! reliability ( address in=mation provid$ "u ! ,m$icaid program 7a7 ,9 g5]al ,section #aijb7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a771 z previ\sly am5d$ by ?is title1 is am5d$-- 7#a7 9 p>agraph 7#hg71 by /rik+ & at ! end2 7#b7 9 p>agraph 7#hh71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7#c7 by ins]t+ aft] p>agraph 7#hh7 ! foll[+ new p>agraph3 7#hi7 beg9n+ ,janu>y #a1 #bjbf1 provide = a process to regul>ly obta9 address in=mation = individuals enroll$ "u su* plan 7or a waiv] ( su* plan7 f reliable data s\rces 7z describ$ 9 section #dce4iai7;f77#a77;iii7 ( title #db1 ,code ( ,f$]al ,regulations 7or a successor regulation77 & act on any *anges to su* an address bas$ on su* in=mation 9 accordance ) su* section 7or successor regulation71 except t ?is p>agraph %all only apply 9 ! case ( ! #ej ,/ates & ! ,di/rict ( ,columbia4 4 7b7 ,application to ,,*ip ,section #bajg7;e77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acig;gg7e77#a77 is am5d$-- 7#a7 by r$esignat+ subp>agraphs 7,h7 ?r\gh 7,u7 z subp>agraphs 7,i7 ?r\gh 7,v71 respectively2 & 7#b7 by ins]t+ aft] subp>agraph 7,g7 ! foll[+ new subp>agraph3 7,h7 ,section #aijb7;a77#hi7 7relat+ to regul>ly obta9+ address in=mation = enrollees74 4 7c7 ,ensur+ transmission ( address in=mation f manag$ c>e organizations ,section #aicb ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#b7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7j7 ,transmission ( address in=mation ,beg9n+ ,janu>y #a1 #bjbf1 ea* contract "u a ,/ate plan ) a manag$ c>e entity "u section #aijc7m7 %all provide t ! entity transmits to ! ,/ate any address in=mation = an individual enroll$ ) ! entity t is provid$ to su* entity directly f1 or v]ifi$ by su* entity directly )1 su* individual4 4 #ajf4 ,codify+ c]ta9 ,m$icaid provid] scre5+ requirem5ts relat$ to deceas$ provid]s ,section #aijb7kk77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7kk77#a77 is am5d$-- 7#a7 by /rik+ ,! ,/ate & ins]t+3 7,a7 ,9 g5]al ,! ,/ate 2 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,b7 ,additional provid] scre5+ ,beg9n+ ,janu>y #a1 #bjbg1 z "p ( ! enrollm5t 7or re5rollm5t or revalidation ( enrollm5t7 ( a provid] or suppli] "u ?is title1 & n less frequ5tly ?an qu>t]ly dur+ ! p]iod t su* provid] or suppli] is s enroll$1 ! ,/ate conducts a *eck ( ! ,dea? ,ma/] ,file 7z su* t]m is def9$ 9 section #bjc7;d7 ( ! ,bip>tisan ,budget ,act ( #bjac7 to det]m9e :e!r su* provid] or suppli] is deceas$4 4 #ajg4 ,modify+ c]ta9 ,/ate requirem5ts = ensur+ deceas$ individuals d n rema9 enroll$ ,section #aijb ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a71 z previ\sly am5d$ by ?is title1 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#hh71 by /rik+ 2 & & ins]t+ a semicolon2 7,b7 9 p>agraph 7#hi71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,c7 by ins]t+ aft] p>agraph 7#hi7 ! foll[+ new p>agraph3 7#ij7 provide t ! ,/ate %all comply ) ! eligibility v]ification requirem5ts "u subsection 7vv71 except t ?is p>agraph %all apply only 9 ! case ( ! #ej ,/ates & ! ,di/rict ( ,columbia4 2 & 7#b7 by add+ at ! end ! foll[+ new subsection3 7vv7 ,v]ification ( c]ta9 eligibility crit]ia 7#a7 ,9 g5]al ,= purposes ( subsection 7a77#ij71 ! eligibility v]ification requirem5ts1 beg9n+ ,janu>y #a1 #bjbf1 are z foll[s3 7,a7 ,qu>t]ly scre5+ to v]ify enrollee /atus ,! ,/ate %all1 n less frequ5tly ?an qu>t]ly1 review ! ,dea? ,ma/] ,file 7z su* t]m is def9$ 9 section #bjc7;d7 ( ! ,bip>tisan ,budget ,act ( #bjac7 to det]m9e :e!r any individuals enroll$ = m$ical assi/ance "u ! ,/ate plan 7or waiv] ( su* plan7 are deceas$4 7,b7 ,dis5rollm5t "u ,/ate plan ,if ! ,/ate det]m9es1 bas$ on in=mation obta9$ f ! ,dea? ,ma/] ,file1 t an individual enroll$ = m$ical assi/ance "u ! ,/ate plan 7or waiv] ( su* plan7 is deceas$1 ! ,/ate %all-- 7i7 treat su* in=mation z factual in=mation confirm+ ! dea? ( a b5efici>y = purposes ( section #dca4bac7;a7 ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation72 7ii7 dis5roll su* individual f ! ,/ate plan 7or waiv] ( su* plan72 & 7iii7 discont9ue any paym5ts = m$ical assi/ance "u ?is title made on behalf ( su* individual 7o!r ?an paym5ts = any items or s]vices furni%$ to su* individual prior to ! dea? ( su* individual74 7,c7 ,re9/atem5t ( cov]age 9 ! ev5t ( error ,if a ,/ate det]m9es t an individual 0 misid5tifi$ z deceas$ bas$ on in=mation obta9$ f ! ,dea? ,ma/] ,file1 & 0 errone\sly dis5roll$ f m$ical assi/ance "u ! ,/ate plan 7or waiv] ( su* plan7 bas$ on su* misid5tification1 ! ,/ate %all imm$iately re5roll su* individual "u ! ,/ate plan 7or waiv] ( su* plan71 retroactive to ! date ( su* dis5rollm5t4 7#b7 ,rule ( con/ruction ,no?+ "u ?is subsection %all be con/ru$ to preclude ! ability ( a ,/ate to use o!r electronic data s\rces to timely id5tify pot5tially deceas$ b5efici>ies1 s long z ! ,/ate is also 9 compliance ) ! requirem5ts ( ?is subsection 7& all o!r requirem5ts "u ?is title relat+ to ,m$icaid eligibility det]m9ation & r$et]m9ation74 4 #ajh4 ,"o-ye> delay ( ,m$icaid & ,,*ip requirem5ts = heal? scre5+s1 ref]rals1 & case managem5t s]vices = eligible juv5iles 9 public in/itutions2 ,/ate int]im "w plans 7a7 ,9 g5]al ,section #eaba7;d7 ( subtitle ,c ( title ,v ( division ,,ff ( ! ,consolidat$ ,appropriations ,act1 #bjbc 7,public ,law #aag-cbh7 is am5d$-- 7#a7 by /rik+ ,! am5dm5ts made by ?is section & ins]t+ ! foll[+3 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 ! am5dm5ts made by ?is section 2 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#b7 ,delay ( date by :i* ,/ates mu/ comply ) c]ta9 juv5ile ju/ice-relat$ requirem5ts ,a ,/ate %all n be reg>d$ z fail+ to comply ) ! requirem5ts ( section #aijb7;a77#hd77;,d7 or #bajb7;d77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#hd77;,d71 #acig;bb7d77#b77 be=e ,janu>y #a1 #bjbf4 4 7b7 ,cl>ify+ nonapplication ( requirem5ts to individuals 9 ,f$]al cu/ody 7#a7 ,m$icaid 7,a7 ,subp>agraph 7,d7 ( section #aijb7;a77#hd7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#hd771 z add$ by section #eaba ( subtitle ,c ( title ,v ( division ,,ff ( ! ,consolidat$ ,appropriations ,act1 #bjbc 7,public ,law #aag-cbh71 is am5d$ by /rik+ an individual :o is an eligible juv5ile & ins]t+ an individual 7o!r ?an an individual :o is 9 ,f$]al cu/ody1 includ+ z an inmate 9 a ,f$]al prison7 :o is an eligible juv5ile4 7,b7 ,section #eabb7;a7 ( subtitle ,c ( title ,v ( division ,,ff ( ! ,consolidat$ ,appropriations ,act1 #bjbc 7,public ,law #aag-cbh7 is am5d$-- 7i7 by /rik+ p>agraph 7#ca7 ea* place x appe>s & ins]t+ ! la/ numb]$ p>agraph2 & 7ii7 9 p>agraph 7#a71 by /rik+ an individual :o is an eligible juv5ile & ins]t+ an individual 7o!r ?an an individual :o is 9 ,f$]al cu/ody1 includ+ z an inmate 9 a ,f$]al prison7 :o is an eligible juv5ile4 7#b7 ,,*ip 7,a7 ,subsection 7d77#b7 ( section #bajb ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acig;bb71 z add$ by section #eaba ( subtitle ,c ( title ,v ( division ,,ff ( ! ,consolidat$ ,appropriations ,act1 #bjbc 7,public ,law #aag-cbh71 is am5d$ by /rik+ a t>get$ l[-income *ild :o & ins]t+ a t>get$ l[ income *ild 7o!r ?an a *ild :o is 9 ,f$]al cu/ody1 includ+ z an inmate 9 a ,f$]al prison7 :o4 7,b7 ,section #eabb7;b77#b7 ( subtitle ,c ( title ,v ( division ,,ff ( ! ,consolidat$ ,appropriations ,act1 #bjbc 7,public ,law #aag-cbh7 is am5d$ by /rik+ a *ild :o is & ins]t+ a *ild 7o!r ?an a *ild :o is 9 ,f$]al cu/ody1 includ+ z an inmate 9 a ,f$]al prison7 :o is4 7#c7 ,effective date ,! am5dm5ts made by ?is subsection %all take effect z if enact$ on ,decemb] #bi1 #bjbb4 7c7 ,int]im "w plan ,n lat] ?an ,june #cj1 #bjbe1 ea* ,/ate 7z su* t]m is def9$ 9 section #aaja7;a77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acja7;a77#a77 = purposes ( titles ,,xix & ,,xxi ( su* ,act7 %all submit to ! ,secret>y ( ,heal? & ,human ,s]vices an int]im "w plan1 9 su* =m & conta9+ su* in=mation z ! ,secret>y may specify1 describ+ ! ,/ate's progress t[>ds implem5t+1 & its plans to come into compliance )1 ! requirem5ts impos$ by ! am5dm5ts made by section #eaba ( subtitle ,c ( title ,v ( division ,,ff ( ! ,consolidat$ ,appropriations ,act1 #bjbc 7,public ,law #aag-cbh71 consi/5t ) ! guidance issu$ by ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices 9 ,/ate ,heal? ,(ficial ,lett] #bd-jjd on ,july #bc1 #bjbd4 #aji4 ,/ate /udies & ,,hhs report on co/s ( provid+ mat]nity1 labor1 & deliv]y s]vices 7a7 ,/ate /udy 7#a7 ,9 g5]al ,n lat] ?an #bd mon?s aft] ! date ( enactm5t ( ?is ,act1 & e #e ye>s !reaft]1 ea* ,/ate 7z su* t]m is def9$ 9 section #aaja7;a77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acja7;a77#a77 = purposes ( titles ,,xix & ,,xxi ( su* ,act7 %all conduct a /udy on ! co/s ( provid+ mat]nity1 labor1 & deliv]y s]vices 9 applicable hospitals 7z def9$ 9 p>agraph 7#c77 & submit ! results ( su* /udy to ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y74 7#b7 ,cont5t ( /udy ,a ,/ate /udy requir$ "u p>agraph 7#a7 %all include ! foll[+ in=mation 7to ! ext5t practicable7 ) respect to mat]nity1 labor1 & deliv]y s]vices furni%$ by applicable hospitals locat$ 9 ! ,/ate3 7,a7 ,an e/imate ( ! co/ ( provid+ mat]nity1 labor1 & deliv]y s]vices at applicable hospitals1 bas$ on ! exp5ditures a repres5tative sample ( su* hospitals incurr$ = provid+ su* s]vices dur+ ! #b mo/ rec5t ye>s = :i* data is available4 7,b7 ,an e/imate ( ! co/ ( provid+ mat]nity1 labor1 & deliv]y s]vices at applicable hospitals t ceas$ provid+ labor & deliv]y s]vices )9 ! pa/ #e ye>s1 bas$ on ! exp5ditures a repres5tative sample ( su* hospitals incurr$ = provid+ su* s]vices dur+ ! #b mo/ rec5t ye>s = :i* data is available4 7,c7 ,to ! ext5t data all[s1 an analysis ( ! ext5t to :i* geographic location1 community demographics1 & local economic factors 7z def9$ by ! ,secret>y7 affect ! co/ ( provid+ mat]nity1 labor1 & deliv]y s]vices at applicable hospitals1 includ+ ! co/ ( s]vices t support ! provision ( mat]nity1 labor1 & deliv]y s]vices4 7,d7 ,! am\nts applicable hospitals are paid = mat]nity1 labor1 & deliv]y s]vices1 by geographic location & hospital size1 "u-- 7i7 ,m$ic>e2 7ii7 ! ,/ate ,m$icaid program1 includ+ paym5t am\nts = su* s]vices "u fee-=-s]vice paym5t arrangem5ts & "u manag$ c>e 7z applicable72 7iii7 ! ,/ate ,,*ip plan1 includ+ paym5t am\nts = su* s]vices "u fee-=-s]vice paym5t arrangem5ts & "u manag$ c>e 7z applicable72 & 7iv7 private heal? insurance4 7,e7 ,a comp>ative paym5t rate analysis-- 7i7 comp>+ paym5t rates = mat]nity1 labor1 & deliv]y s]vices 7inclusive ( all paym5ts receiv$ by applicable hospitals = furni%+ mat]nity1 labor1 & deliv]y s]vices7 "u ! ,/ate ,m$icaid fee-=-s]vice program to su* paym5t rates = su* s]vices "u ,m$ic>e 7z describ$ 9 section #ddg4bjc7;b77#c7 ( title #db1 ,code ( ,f$]al ,regulations71 o!r ,f$]ally-fund$ or ,/ate-fund$ programs 7includ+1 to ! ext5t data is available1 ,m$icaid manag$ c>e rates71 & to ! paym5t rates = su* s]vices1 to ! ext5t data is available1 ( private heal? insur]s )9 geographic areas ( ! ,/ate2 & 7ii7 analyz+ diff]5t paym5t me?ods = su* s]vices1 su* z ! use ( bundl$ paym5ts1 quality inc5tives1 & l[-volume adju/m5ts4 7,f7 ,an evaluation1 us+ su* me?odology & p>amet]s e/abli%$ by ! ,secret>y1 ( :e!r ea* hospital locat$ 9 ! ,/ate t furni%es mat]nity1 labor1 & deliv]y s]vices is expect$ to exp]i5ce 9 ! next #c ye>s significant *anges 9 p>ticul> exp5ditures or types ( reimbursem5t = mat]nity1 labor1 & deliv]y s]vices4 7#c7 ,applicable hospital def9$ ,= purposes ( ?is subsection1 ! t]m applicable hospital means any hospital locat$ 9 a ,/ate t meets ei!r ( ! foll[+ crit]ia3 7,a7 ,! hospital provides labor & deliv]y s]vices & m ?an #ej p]c5t ( ! hospital's bir?s 79 ! mo/ rec5t ye> = :i* su* data is available7 are f9anc$ by ! ,m$icaid program or ,,*ip4 7,b7 ,! hospital-- 7i7 is locat$ 9 a rural area 7z def9$ by ! ,f$]al ,(fice ( ,rural ,heal? ,policy = ! purpose ( rural heal? grant programs adm9i/]$ by su* ,(fice72 7ii7 bas$ on ! mo/ rec5t #b ye>s ( data available 7z det]m9$ by ! ,secret>y71 furni%$ s]vices = less ?an an av]age ( #cjj bir?s p] ye>2 & 7iii7 provides labor & deliv]y s]vices4 7#d7 ,assi/ance to small hospitals 9 compil+ co/ in=mation ,!re are appropriat$ to ! ,secret>y = fiscal ye> #bjbe1 #aj1jjj1jjj = ! purpose ( provid+ grants & te*nical assi/ance to a hospital describ$ 9 p>agraph 7#c77;,b7 to enable su* hospital to compile detail$ in=mation = use 9 ! ,/ate /udies requir$ "u p>agraph 7#a71 to rema9 available until exp5d$4 7#e7 ,,hhs report on ,/ate /udies ,= ea* ye> 9 :i* a ,/ate is requir$ to conduct a /udy "u p>agraph 7#a71 ! ,secret>y %all issue1 n lat] ?an #ab mon?s aft] ! date on :i* ! ,/ate submits to ! ,secret>y ! data describ$ 9 su* p>agraph1 a publicly available report t compiles & details ! results ( su* /udy & includes ! in=mation describ$ 9 p>agraph 7#b74 7b7 ,,hhs report on national data collection f9d+s ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all submit to ,congress1 & make publicly available1 a report analyz+ ! fir/ /udies conduct$ by ,/ates "u subsection 7a77#a71 includ+ recomm5dations = improv+ data collection on ! co/ ( provid+ mat]nity1 labor1 & deliv]y s]vices4 7c7 ,implem5tation fund+ ,9 addition to ! am\nt appropriat$ "u subsection 7a77#d71 !re are appropriat$1 out ( any funds 9 ! ,treasury n o!rwise obligat$1 #c1jjj1jjj = fiscal ye> #bjbe1 to rema9 available until exp5d$1 to ! ,secret>y ( ,heal? & ,human ,s]vices = purposes ( implem5t+ ?is section4 #aaj4 ,modify+ c]ta9 disproportionate %>e hospital allotm5ts 7a7 ,ext5d+ ,t5nessee ,,d% allotm5ts ,section #aibc7;f77#f77;,a77vi7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#d7;f77#f77;,a77vi77 is am5d$-- 7#a7 9 ! head+1 by /rik+ #bjbe & ins]t+ #bjbf & = ! #a/ qu>t] ( fiscal ye> #bjbg2 7#b7 by /rik+ fiscal ye> #bjbe & ins]t+ fiscal ye> #bjbf2 & 7#c7 by ins]t+ 1 & ! ,,d% allotm5t = ,t5nessee = ! #a/ qu>t] ( fiscal ye> #bjbg1 %all be #ac1bge1jjj be=e ! p]iod4 7b7 ,elim9at+ & delay+ ,,d% allotm5t r$uctions ,section #aibc7;f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#d7;f77 is am5d$-- 7#a7 9 p>agraph 7#g77;,a7-- 7,a7 9 clause 7i71 9 ! matt] prec$+ subclause 7,i71 by /rik+ ,april #a1 #bjbe1 & all t foll[s ?r\gh #bjbg & ins]t+ ,janu>y #a1 #bjbg1 & end+ ,septemb] #cj1 #bjbg1 & = fiscal ye> #bjbh2 & 7,b7 9 clause 7ii71 by /rik+ ,april #a1 #bjbe1 & all t foll[s ?r\gh #bjbg & ins]t+ ,janu>y #a1 #bjbg1 & end+ ,septemb] #cj1 #bjbg1 & = fiscal ye> #bjbh2 & 7#b7 9 p>agraph 7#h71 by /rik+ #bjbg & ins]t+ #bjbh4 #aaa4 ,modify+ c]ta9 limitations on disproportionate %>e hospital paym5t adju/m5ts "u ! ,m$icaid program 7a7 ,9 g5]al ,section #aibc7;g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#d7;g77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 ! matt] prec$+ clause 7i71 by /rik+ 7o!r ?an a hospital describ$ 9 p>agraph 7#b77;,b772 7ii7 9 clause 7i71 by ins]t+ ) respect to su* hospital & ye> aft] describ$ 9 subp>agraph 7,b72 & 7iii7 9 clause 7ii7-- 7,i7 9 subclause 7,i71 by /rik+ & at ! end2 7,,ii7 9 subclause 7,,ii71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,,iii7 by add+ at ! end ! foll[+ new subclause3 7,,iii7 paym5ts made "u title ,,xviii or by an applicable plan 7z def9$ 9 section #ahfb7;b77#h77;,f77 = su* s]vices4 2 & 7,b7 9 subp>agraph 7,b7-- 7i7 9 ! matt] prec$+ clause 7i71 by /rik+ 9 ?is clause are & ins]t+ 9 ?is subp>agraph are1 ) respect to a hospital & a ye>12 & 7ii7 by add+ at ! end ! foll[+ new clause3 7iii7 ,individuals :o are eligible = m$ical assi/ance "u ! ,/ate plan or "u a waiv] ( su* plan & = :om ! ,/ate plan or waiv] is a payor = su* s]vices aft] application ( b5efits "u title ,,xviii or "u an applicable plan 7z def9$ 9 section #ahfb7;b77#h77;,f771 b only if ! hospital has 9 ! aggregate incurr$ co/s exce$+ paym5ts "u su* ,/ate plan1 waiv]1 title ,,xviii1 or applicable plan = su* s]vices furni%$ to su* individuals dur+ su* ye>4 2 7#b7 by /rik+ p>agraph 7#b72 7#c7 by r$esignat+ p>agraph 7#c7 z p>agraph 7#b72 & 7#d7 9 p>agraph 7#b71 z s r$esignat$1 by /rik+ ,not)/&+ p>agraph 7#b7 ( ?is subsection 7z 9 effect on ,octob] #a1 #bjba71 p>agraph 7#b7 & ins]t+ ,p>agraph 7#b74 7b7 ,effective date 7#a7 ,9 g5]al ,except z provid$ 9 p>agraph 7#b71 ! am5dm5ts made by ?is section %all apply to paym5t adju/m5ts made "u section #aibc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#d7 = ,m$icaid ,/ate plan rate ye>s beg9n+ on or aft] ! date ( enactm5t ( ?is ,act4 7#b7 ,/ate option to di/ribute unsp5t ,,d% allotm5ts f prior ye>s up to modifi$ cap 7,a7 ,9 g5]al ,if1 = any ,m$icaid ,/ate plan rate ye> t beg9s on or aft] ,octob] #a1 #bjba1 & be=e ! date ( enactm5t ( ?is ,act1 a ,/ate did n sp5d ! full am\nt ( its ,f$]al fiscal ye> allotm5t "u section #aibc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#d7 applicable to t ,/ate plan rate ye>1 ! ,/ate may use ! unsp5t portion ( su* allotm5t to increase ! am\nt ( any paym5t adju/m5t made to a hospital = su* rate ye>1 provid$ t-- 7i7 su* paym5t adju/m5t 7z s increas$7 is consi/5t ) subsection 7g7 ( su* section 7z am5d$ by ?is section72 & 7ii7 ! total am\nt ( all paym5t adju/m5ts = ! ,/ate plan rate ye> 7z s increas$7 does n exce$ ! disproportionate %>e hospital allotm5t = ! ,/ate & applicable ,f$]al fiscal ye> "u subsection 7f7 ( su* section4 7,b7 ,no rec\pm5t ( paym5ts already made to hospitals ,a ,/ate %all n rec\p any paym5t adju/m5t made by ! ,/ate to a hospital = a ,m$icaid ,/ate plan rate ye> describ$ 9 subp>agraph 7,a7 if su* paym5t adju/m5t is consi/5t ) section #aibc7;g7 ( su* ,act 7#db ,u4,s4,c4 #acifr-#d7;g77 z 9 effect on ,octob] #a1 #bjba4 7,c7 ,au?ority to p]mit retroactive modification ( ,/ate plan am5dm5ts to all[ = increases 7i7 ,9 g5]al ,subject to p>agraph 7#b71 solely = ! purpose ( all[+ a ,/ate to increase ! am\nt ( a paym5t adju/m5t to a hospital = a ,m$icaid ,/ate plan rate ye> describ$ 9 subp>agraph 7,a7 pursuant to ?is p>agraph1 a ,/ate may retroactively modify a provision ( ! ,m$icaid ,/ate plan1 a waiv] ( su* plan1 or a ,/ate plan am5dm5t t relates to su* rate ye> & ! ,secret>y may approve su* modification4 7ii7 ,deadl9e ,a ,/ate may n submit a reque/ = approval ( a retroactive modification to a provision ( ! ,m$icaid ,/ate plan1 a waiv] ( su* plan1 or a ,/ate plan am5dm5t = a ,m$icaid ,/ate plan rate ye> aft] ! date by :i* ! ,/ate is requir$ to submit ! indep5d5t c]tifi$ audit = t ,/ate plan rate ye> z requir$ "u section #aibc7;j77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#d7;j77#b774 7,d7 ,report+ ,if a ,/ate increases a paym5t adju/m5t made to a hospital = a ,m$icaid ,/ate plan rate ye> pursuant to ?is p>agraph1 ! ,/ate %all include in=mation on su* increas$ paym5t adju/m5t z "p ( ! next annual report submitt$ by ! ,/ate "u section #aibc7;j77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#d7;j77#a774 #aab4 ,ensur+ accurate paym5ts to ph>macies "u ,m$icaid 7a7 ,9 g5]al ,section #aibg7;f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;f77 is am5d$-- 7#a7 9 p>agraph 7#a77;,a7-- 7,a7 by r$esignat+ clause 7ii7 z clause 7iii72 & 7,b7 by /rik+ & aft] ! semicolon at ! end ( clause 7i7 & all t prec$es x ?r\gh 7#a7 & ins]t+ ! foll[+3 7#a7 ,det]m9+ ph>macy actual acquisition co/s ,! ,secret>y %all conduct a survey ( retail community ph>macy drug prices & applicable non-retail ph>macy drug prices to det]m9e national av]age drug acquisition co/ b5*m>ks 7z su* t]m is def9$ by ! ,secret>y7 z foll[s3 7,a7 ,use ( v5dor ,! ,secret>y may contract s]vices =-- 7i7 ) respect to retail community ph>macies1 ! det]m9ation ( retail survey prices ( ! national av]age drug acquisition co/ = cov]$ outpati5t drugs t repres5t a nationwide av]age ( consum] pur*ase prices = su* drugs1 net ( all disc\nts1 rebates1 & o!r price concessions 7to ! ext5t any in=mation ) respect to su* disc\nts1 rebates1 & o!r price concessions is available7 bas$ on a mon?ly survey ( su* ph>macies2 7ii7 ) respect to applicable non-retail ph>macies-- 7,i7 ! det]m9ation ( survey prices1 sep>ate f ! survey prices describ$ 9 clause 7i71 ( ! non-retail national av]age drug acquisition co/ = cov]$ outpati5t drugs t repres5t a nationwide av]age ( consum] pur*ase prices = su* drugs1 net ( all disc\nts1 rebates1 & o!r price concessions 7to ! ext5t any in=mation ) respect to su* disc\nts1 rebates1 & o!r price concessions is available7 bas$ on a mon?ly survey ( su* ph>macies2 & 7,,ii7 at ! discretion ( ! ,secret>y1 = ea* type ( applicable non-retail ph>macy1 ! det]m9ation ( survey prices1 sep>ate f ! survey prices describ$ 9 clause 7i7 or subclause 7,i7 ( ?is clause1 ( ! national av]age drug acquisition co/ = su* type ( ph>macy = cov]$ outpati5t drugs t repres5t a nationwide av]age ( consum] pur*ase prices = su* drugs1 net ( all disc\nts1 rebates1 & o!r price concessions 7to ! ext5t any in=mation ) respect to su* disc\nts1 rebates1 & o!r price concessions is available7 bas$ on a mon?ly survey ( su* ph>macies2 & 2 7#b7 9 subp>agraph 7,b7 ( p>agraph 7#a71 by /rik+ subp>agraph 7,a77ii7 & ins]t+ subp>agraph 7,a77iii72 7#c7 9 subp>agraph 7,d7 ( p>agraph 7#a71 by /rik+ clauses 7ii7 & 7iii7 & ins]t+ ! foll[+3 7ii7 ,! v5dor mu/ update ! ,secret>y no less (t5 ?an mon?ly on ! survey prices = cov]$ outpati5t drugs4 7iii7 ,! v5dor mu/ diff]5tiate1 9 collect+ & report+ survey data1 = all co/ in=mation collect$1 :e!r a ph>macy is a retail community ph>macy or an applicable non-retail ph>macy1 includ+ :e!r su* ph>macy is an affiliate 7z def9$ 9 subsection 7k77#ad771 &1 9 ! case ( an applicable non-retail ph>macy1 :i* type ( applicable non-retail ph>macy x is us+ ! relevant ph>macy type indicators includ$ 9 ! guidance requir$ by subsection 7d77#b7 ( section #aab ( ! ,bip>tisan ,heal? ,c>e ,act4 2 7#d7 by add+ at ! end ( p>agraph 7#a7 ! foll[+3 7,f7 ,survey report+ ,9 ord] to meet ! requirem5t ( section #aijb7;a77#ed71 a ,/ate %all require t any retail community ph>macy or applicable non-retail ph>macy 9 ! ,/ate t receives any paym5t1 reimbursem5t1 adm9i/rative fee1 disc\nt1 rebate1 or o!r price concession relat$ to ! disp5s+ ( cov]$ outpati5t drugs to individuals receiv+ b5efits "u ?is title1 reg>dless ( :e!r su* paym5t1 reimbursem5t1 adm9i/rative fee1 disc\nt1 rebate1 or o!r price concession is receiv$ f ! ,/ate or a manag$ c>e entity or o!r specifi$ entity 7z su* t]ms are def9$ 9 section #aijc7m77#i77;,d77 directly or f a ph>macy b5efit manag] or ano!r entity t has a contract ) ! ,/ate or a manag$ c>e entity or o!r specifi$ entity 7z s def9$71 %all respond to surveys conduct$ "u ?is p>agraph4 7,g7 ,survey in=mation ,in=mation on national drug acquisition prices obta9$ "u ?is p>agraph %all be made publicly available 9 a =m & mann] to be det]m9$ by ! ,secret>y & %all include at lea/ ! foll[+3 7i7 ,! mon?ly response rate to ! survey includ+ a li/ ( ph>macies n 9 compliance ) subp>agraph 7,f74 7ii7 ,! sampl+ me?odology & numb] ( ph>macies sampl$ mon?ly4 7iii7 ,in=mation on price concessions to ph>macies1 includ+ disc\nts1 rebates1 & o!r price concessions1 to ! ext5t t su* in=mation may be publicly releas$ & has be5 collect$ by ! ,secret>y z "p ( ! survey4 7,h7 ,p5alties 7i7 ,9 g5]al ,subject to clauses 7ii71 7iii71 & 7iv71 ! ,secret>y %all en=ce ! provisions ( ?is p>agraph ) respect to a ph>macy ?r\gh ! e/abli%m5t ( civil money p5alties applicable to a retail community ph>macy or an applicable non-retail ph>macy4 7ii7 ,basis = p5alties ,! ,secret>y %all impose a civil money p5alty e/abli%$ "u ?is subp>agraph on a retail community ph>macy or applicable non-retail ph>macy if-- 7,i7 ! retail ph>macy or applicable non-retail ph>macy refuses or o!rwise fails to respond to a reque/ = in=mation ab\t prices 9 connection ) a survey "u ?is subsection2 7,,ii7 kn[+ly provides false in=mation 9 response to su* a survey2 or 7,,iii7 o!rwise fails to comply ) ! requirem5ts e/abli%$ "u ?is p>agraph4 7iii7 ,p>amet]s = p5alties 7,i7 ,9 g5]al ,a civil money p5alty e/abli%$ "u ?is subp>agraph may be assess$ ) respect to ea* violation1 & ) respect to ea* non-compliant retail community ph>macy 7includ+ a ph>macy t is "p ( a *a97 or non-compliant applicable non-retail ph>macy 7includ+ a ph>macy t is "p ( a *a971 9 an am\nt n to exce$ #ajj1jjj = ea* su* violation4 7,,ii7 ,consid]ations ,9 det]m9+ ! am\nt ( a civil money p5alty impos$ "u ?is subp>agraph1 ! ,secret>y may consid] ! size1 bus9ess /ructure1 & type ( ph>macy involv$1 z well z ! type ( violation & o!r relevant factors1 z det]m9$ appropriate by ! ,secret>y4 7iv7 ,rule ( application ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil money p5alty "u ?is subp>agraph 9 ! same mann] z su* provisions apply to a civil money p5alty or proce$+ "u section #aabh;,a7a74 7,i7 ,limitation on use ( applicable non-retail ph>macy pric+ in=mation ,no ,/ate %all use pric+ in=mation report$ by applicable non-retail ph>macies "u subp>agraph 7,a77ii7 to develop or in=m paym5t me?odologies = retail community ph>macies4 2 7#e7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a71 by ins]t+ 1 includ+ paym5t rates & me?odologies = det]m9+ +r$i5t co/ reimbursem5t "u manag$ c>e entities or o!r specifi$ entities 7z su* t]ms are def9$ 9 section #aijc7m77#i77;,d771 aft] "u ?is title2 & 7,b7 9 subp>agraph 7,b71 by ins]t+ & ! basis = su* disp5s+ fees be=e ! semicolon2 7#f7 by r$esignat+ p>agraph 7#d7 z p>agraph 7#e72 7#g7 by ins]t+ aft] p>agraph 7#c7 ! foll[+ new p>agraph3 7#d7 ,ov]sight 7,a7 ,9 g5]al ,! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all conduct p]iodic /udies ( ! survey data report$ "u ?is subsection1 z appropriate1 includ+ ) respect to sub/antial v>iations 9 acquisition co/s or o!r applicable co/s1 z well z ) respect to h[ int]nal transf] prices & relat$ p>ty transactions may influ5ce ! co/s report$ by ph>macies t are affiliates 7z def9$ 9 subsection 7k77#ad77 or are own$ by1 controll$ by1 or relat$ "u a common own]%ip /ructure ) a :olesal]1 di/ributor1 or o!r entity t acquires cov]$ outpati5t drugs relative to co/s report$ by ph>macies n affiliat$ ) su* entities4 ,! ,inspector ,g5]al %all provide p]iodic updates to ,congress on ! results ( su* /udies1 z appropriate1 9 a mann] t does n disclose trade secrets or o!r propriet>y in=mation4 7,b7 ,appropriation ,!re is appropriat$ to ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 out ( any money 9 ! ,treasury n o!rwise appropriat$1 #e1jjj1jjj = fiscal ye> #bjbe1 to rema9 available until exp5d$1 to c>ry out ?is p>agraph4 2 & 7#h7 9 p>agraph 7#e71 z s r$esignat$-- 7,a7 by ins]t+ 1 & #i1jjj1jjj = fiscal ye> #bjbe & ea* fiscal ye> !reaft]1 aft] #bjaj2 & 7,b7 by ins]t+ ,funds appropriat$ "u ?is p>agraph = fiscal ye> #bjbe & any subsequ5t fiscal ye> %all rema9 available until exp5d$4 aft] ! p]iod4 7b7 ,def9itions ,section #aibg7k7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77 is am5d$-- 7#a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ ,9 ! section & ins]t+ ,9 ?is section2 & 7#b7 by add+ at ! end ! foll[+ new p>agraphs3 7#ab7 ,applicable non-retail ph>macy ,! t]m applicable non-retail ph>macy means a ph>macy t is lic5s$ z a ph>macy by ! ,/ate & t is n a retail community ph>macy1 includ+ a ph>macy t disp5ses prescription m$ications to pati5ts prim>ily ?r\gh mail & specialty ph>macies4 ,su* t]m does n include nurs+ home ph>macies1 long-t]m c>e facility ph>macies1 hospital ph>macies1 cl9ics1 *>itable or n-=-pr(it ph>macies1 gov]nm5t ph>macies1 or l[ disp5s+ ph>macies 7z def9$ by ! ,secret>y74 7#ac7 ,affiliate ,! t]m affiliate means any entity t is own$ by1 controll$ by1 or relat$ "u a common own]%ip /ructure ) a ph>macy b5efit manag] or a manag$ c>e entity or o!r specifi$ entity 7z su* t]ms are def9$ 9 section #aijc7m77#i77;,d774 4 7c7 ,effective date 7#a7 ,9 g5]al ,subject to p>agraph 7#b71 ! am5dm5ts made by ?is section %all take effect on ! fir/ day ( ! fir/ qu>t] t beg9s on or aft] ! date t is #f mon?s aft] ! date ( enactm5t ( ?is ,act4 7#b7 ,delay$ application to applicable non-retail ph>macies ,! ph>macy survey requirem5ts e/abli%$ by ! am5dm5ts to section #aibg7;f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;f77 made by ?is section %all apply to retail community ph>macies beg9n+ on ! effective date describ$ 9 p>agraph 7#a71 b %all n apply to applicable non-retail ph>macies until ! fir/ day ( ! fir/ qu>t] t beg9s on or aft] ! date t is #ah mon?s aft] ! date ( enactm5t ( ?is ,act4 7d7 ,id5tification ( applicable non-,retail ph>macies 7#a7 ,9 g5]al ,n lat] ?an ,janu>y #a1 #bjbf1 ! ,secret>y ( ,heal? & ,human ,s]vices %all1 9 consultation ) /akehold]s z appropriate1 publi% guidance specify+ ph>macies t meet ! def9ition ( applicable non-retail ph>macies 7z su* t]m is def9$ 9 subsection 7k77#ab7 ( section #aibg ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h71 z add$ by subsection 7b771 & t w be subject to ! survey requirem5ts "u subsection 7f77#a7 ( su* section1 z am5d$ by subsection 7a74 7#b7 ,inclusion ( ph>macy type indicators ,! guidance publi%$ "u p>agraph 7#a7 %all include ph>macy type indicators to di/+ui% betwe5 diff]5t types ( applicable non-retail ph>macies1 su* z ph>macies t disp5se prescriptions prim>ily ?r\gh ! mail & ph>macies t disp5se prescriptions t require special h&l+ or di/ribution4 ,an applicable non-retail ph>macy may be id5tifi$ ?r\gh multiple ph>macy type indicators4 7e7 ,implem5tation 7#a7 ,9 g5]al ,not)/&+ any o!r provision ( law1 ! ,secret>y ( ,heal? & ,human ,s]vices may implem5t ! am5dm5ts made by ?is section by program in/ruction or o!rwise4 7#b7 ,nonapplication ( ,adm9i/rative ,proc$ure ,act ,implem5tation ( ! am5dm5ts made by ?is section %all be exempt f ! requirem5ts ( section #eec ( title #e1 ,unit$ ,/ates ,code4 7f7 ,nonapplication ( pap]work r$uction act ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to any data collection und]tak5 by ! ,secret>y ( ,heal? & ,human ,s]vices "u section #aibg7;f7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;f771 z am5d$ by ?is section4 #aac4 ,prev5t+ ! use ( abusive spread pric+ 9 ,m$icaid 7a7 ,9 g5]al ,section #aibg ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7 is am5d$-- 7#a7 9 subsection 7e71 by add+ at ! end ! foll[+ new p>agraph3 7#f7 ,transp>5t prescription drug pass-?r\gh pric+ requir$ 7,a7 ,9 g5]al ,a contract betwe5 ! ,/ate & a ph>macy b5efit manag] 7ref]r$ to 9 ?is p>agraph z a ,,pbm71 or a contract betwe5 ! ,/ate & a manag$ c>e entity or o!r specifi$ entity 7z su* t]ms are def9$ 9 section #aijc7m77#i77;,d7 & collectively ref]r$ to 9 ?is p>agraph z ! entity7 t includes provisions mak+ ! entity responsible = cov]age ( cov]$ outpati5t drugs disp5s$ to individuals enroll$ ) ! entity1 %all require t paym5t = su* drugs & relat$ adm9i/rative s]vices 7z applicable71 includ+ paym5ts made by a ,,pbm on behalf ( ! ,/ate or entity1 is bas$ on a transp>5t prescription drug pass-?r\gh pric+ model "u :i*-- 7i7 any paym5t made by ! entity or ! ,,pbm 7z applicable7 = su* a drug-- 7,i7 is limit$ to-- 7aa7 +r$i5t co/2 & 7bb7 a pr(essional disp5s+ fee t is n less ?an ! pr(essional disp5s+ fee t ! ,/ate w\ld pay if ! ,/ate 7 mak+ ! paym5t directly 9 accordance ) ! ,/ate plan2 7,,ii7 is pass$ ?r\gh 9 its entirety 7except z r$uc$ "u ,f$]al or ,/ate laws & regulations 9 response to in/ances ( wa/e1 fraud1 or abuse7 by ! entity or ,,pbm to ! ph>macy or provid] t disp5ses ! drug2 & 7,,iii7 is made 9 a mann] t is consi/5t ) sections #ddg4ejb1 #ddg4eab1 #ddg4ead1 & #ddg4eah ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation7 z if su* requirem5ts appli$ directly to ! entity or ! ,,pbm1 except t any paym5t by ! entity or ! ,,pbm = ! +r$i5t co/ ( su* drug pur*as$ by a cov]$ entity 7z def9$ 9 subsection 7a77#e77;,b77 may exce$ ! actual acquisition co/ 7z def9$ 9 #ddg4ejb ( title #db1 ,code ( ,f$]al ,regulations1 or any successor regulation7 = su* drug if-- 7aa7 su* drug 0 subject to an agreem5t "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act2 7bb7 su* paym5t = ! +r$i5t co/ ( su* drug does n exce$ ! maximum paym5t t w\ld h be5 made by ! entity or ! ,,pbm = ! +r$i5t co/ ( su* drug if su* drug _h n be5 pur*as$ by su* cov]$ entity2 & 7cc7 su* cov]$ entity reports to ! ,secret>y 79 a =m & mann] specifi$ by ! ,secret>y71 on an annual basis & ) respect to paym5ts = ! +r$i5t co/s ( su* drugs s pur*as$ by su* cov]$ entity t are 9 excess ( ! actual acquisition co/s = su* drugs1 ! aggregate am\nt ( su* excess2 7ii7 paym5t to ! entity or ! ,,pbm 7z applicable7 = adm9i/rative s]vices p]=m$ by ! entity or ,,pbm is limit$ to an adm9i/rative fee t reflects ! fair m>ket value 7z def9$ by ! ,secret>y7 ( su* s]vices2 7iii7 ! entity or ! ,,pbm 7z applicable7 makes available to ! ,/ate1 & ! ,secret>y ^u reque/ 9 a =m & mann] specifi$ by ! ,secret>y1 all co/s & paym5ts relat$ to cov]$ outpati5t drugs & accompany+ adm9i/rative s]vices 7z describ$ 9 clause 7ii77 incurr$1 receiv$1 or made by ! entity or ! ,,pbm1 brok5 d[n 7z specifi$ by ! ,secret>y71 to ! ext5t su* co/s & paym5ts are attributable to an individual cov]$ outpati5t drug1 by ea* su* drug1 includ+ any +r$i5t co/s1 pr(essional disp5s+ fees1 adm9i/rative fees 7z describ$ 9 clause 7ii771 po/-sale & po/-invoice fees1 disc\nts1 or relat$ adju/m5ts su* z direct & indirect remun]ation fees1 & any & all o!r remun]ation1 z def9$ by ! ,secret>y2 & 7iv7 any =m ( spread pric+ :]eby any am\nt *>g$ or claim$ by ! entity or ! ,,pbm 7z applicable7 t exce$s ! am\nt paid to ! ph>macies or provid]s on behalf ( ! ,/ate or entity1 includ+ any po/-sale or po/-invoice fees1 disc\nts1 or relat$ adju/m5ts su* z direct & indirect remun]ation fees or assessm5ts1 z def9$ by ! ,secret>y1 7aft] all[+ = an adm9i/rative fee z describ$ 9 clause 7ii77 is n all[able = purposes ( claim+ ,f$]al mat*+ paym5ts "u ?is title4 7,b7 ,publication ( in=mation ,! ,secret>y %all publi%1 n less frequ5tly ?an on an annual basis & 9 a mann] t does n disclose ! id5tity ( a p>ticul> cov]$ entity or organization1 in=mation receiv$ by ! ,secret>y pursuant to subp>agraph 7,a77iii77,,iii7 t is brok5 out by ,/ate & by ea* ( ! foll[+ categories ( cov]$ entity )9 ea* su* ,/ate3 7i7 ,cov]$ entities describ$ 9 subp>agraph 7,a7 ( section #cdj;,b7a77#d7 ( ! ,public ,heal? ,s]vice ,act4 7ii7 ,cov]$ entities describ$ 9 subp>agraphs 7,b7 ?r\gh 7,k7 ( su* section4 7iii7 ,cov]$ entities describ$ 9 subp>agraph 7,l7 ( su* section4 7iv7 ,cov]$ entities describ$ 9 subp>agraph 7,m7 ( su* section4 7v7 ,cov]$ entities describ$ 9 subp>agraph 7,n7 ( su* section4 7vi7 ,cov]$ entities describ$ 9 subp>agraph 7,o7 ( su* section4 2 & 7#b7 9 subsection 7k71 z previ\sly am5d$ by ?is title1 by add+ at ! end ! foll[+ new p>agraph3 7#ad7 ,ph>macy b5efit manag] ,! t]m ph>macy b5efit manag] means any p]son or entity t1 ei!r directly or ?r\gh an int]m$i>y1 acts z a price negotiator or gr\p pur*as] on behalf ( a ,/ate1 manag$ c>e entity 7z def9$ 9 section #aijc7m77#i77;,d771 or o!r specifi$ entity 7z s def9$71 or manages ! prescription drug b5efits provid$ by a ,/ate1 manag$ c>e entity1 or o!r specifi$ entity1 includ+ ! process+ & paym5t ( claims = prescription drugs1 ! p]=mance ( drug utilization review1 ! process+ ( drug prior au?orization reque/s1 ! manag+ ( appeals or grievances relat$ to ! prescription drug b5efits1 contract+ ) ph>macies1 controll+ ! co/ ( cov]$ outpati5t drugs1 or ! provision ( s]vices relat$ !reto4 ,su* t]m includes any p]son or entity t acts z a price negotiator 7) reg>d to paym5t am\nts to ph>macies & provid]s = a cov]$ outpati5t drug or ! net co/ ( ! drug7 or gr\p pur*as] on behalf ( a ,/ate1 manag$ c>e entity1 or o!r specifi$ entity or t c>ries out #a or m ( ! o!r activities describ$ 9 ! prec$+ s5t5ce1 irrespective ( :e!r su* p]son or entity calls itself a ph>macy b5efit manag]4 4 7b7 ,con=m+ am5dm5ts ,section #aijc7m7 ( su* ,act 7#db ,u4,s4,c4 #acif;b7m77 is am5d$-- 7#a7 9 p>agraph 7#b77;,a77xiii7-- 7,a7 by /rik+ & 7,,iii7 & ins]t+ 7,,iii72 7,b7 by ins]t+ be=e ! p]iod at ! end ! foll[+3 1 & 7,,iv7 if ! contract includes provisions mak+ ! entity responsible = cov]age ( cov]$ outpati5t drugs1 ! entity %all comply ) ! requirem5ts ( section #aibg7;e77#f72 & 7,c7 by mov+ ! m>g9 #b ems to ! left2 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#aj7 ,no paym5t %all be made "u ?is title to a ,/ate ) respect to exp5ditures incurr$ by ! ,/ate = paym5t = s]vices provid$ by an o!r specifi$ entity 7z def9$ 9 p>agraph 7#i77;,d77iii77 unless su* s]vices are provid$ 9 accordance ) a contract betwe5 ! ,/ate & su* entity :i* satisfies ! requirem5ts ( p>agraph 7#b77;,a77xiii74 4 7c7 ,effective date ,! am5dm5ts made by ?is section %all apply to contracts betwe5 ,/ates & manag$ c>e entities1 o!r specifi$ entities1 or ph>macy b5efit manag]s t h an effective date beg9n+ on or aft] ! date t is #ah mon?s aft] ! date ( enactm5t ( ?is ,act4 7d7 ,implem5tation 7#a7 ,9 g5]al ,not)/&+ any o!r provision ( law1 ! ,secret>y ( ,heal? & ,human ,s]vices may implem5t ! am5dm5ts made by ?is section by program in/ruction or o!rwise4 7#b7 ,nonapplication ( adm9i/rative proc$ure act ,implem5tation ( ! am5dm5ts made by ?is section %all be exempt f ! requirem5ts ( section #eec ( title #e1 ,unit$ ,/ates ,code4 7e7 ,nonapplication ( pap]work r$uction act ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to any data collection und]tak5 by ! ,secret>y ( ,heal? & ,human ,s]vices "u section #aibg7;e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;e771 z am5d$ by ?is section4 ,,ii ,m$ic>e #bja4 ,ext5sion ( increas$ inpati5t hospital paym5t adju/m5t = c]ta9 l[-volume hospitals 7a7 ,9 g5]al ,section #ahhf7;d77#ab7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#ab77 is am5d$-- 7#a7 9 subp>agraph 7,b71 9 ! matt] prec$+ clause 7i71 by /rik+ fiscal ye> #bjbe beg9n+ on ,april #a1 #bjbe1 & end+ on ,septemb] #cj1 #bjbe1 & 9 fiscal ye> #bjbf & ins]t+ fiscal ye> #bjbf beg9n+ on ,janu>y #a1 #bjbf1 & end+ on ,septemb] #cj1 #bjbf1 & 9 fiscal ye> #bjbg2 7#b7 9 subp>agraph 7,c77i7-- 7,a7 9 ! matt] prec$+ subclause 7,i71 by /rik+ ?r\gh #bjbd & ! portion ( fiscal ye> #bjbe beg9n+ on ,octob] #a1 #bjbd1 & end+ on ,m>* #ca1 #bjbe & ins]t+ ?r\gh #bjbe & ! portion ( fiscal ye> #bjbf beg9n+ on ,octob] #a1 #bjbe1 & end+ on ,decemb] #ca1 #bjbe2 7,b7 9 subclause 7,,iii71 by /rik+ ?r\gh #bjbd & ! portion ( fiscal ye> #bjbe beg9n+ on ,octob] #a1 #bjbd1 & end+ on ,m>* #ca1 #bjbe & ins]t+ ?r\gh #bjbe & ! portion ( fiscal ye> #bjbf beg9n+ on ,octob] #a1 #bjbe1 & end+ on ,decemb] #ca1 #bjbe2 & 7,c7 9 subclause 7,,iv71 by /rik+ fiscal ye> #bjbe beg9n+ on ,april #a1 #bjbe1 & end+ on ,septemb] #cj1 #bjbe1 & fiscal ye> #bjbf & ins]t+ fiscal ye> #bjbf beg9n+ on ,janu>y #a1 #bjbf1 & end+ on ,septemb] #cj1 #bjbf1 & fiscal ye> #bjbg2 & 7#c7 9 subp>agraph 7,d7-- 7,a7 9 ! matt] prec$+ clause 7i71 by /rik+ ?r\gh #bjbd or dur+ ! portion ( fiscal ye> #bjbe beg9n+ on ,octob] #a1 #bjbd1 & end+ on ,m>* #ca1 #bjbe & ins]t+ ?r\gh #bjbe or dur+ ! portion ( fiscal ye> #bjbf beg9n+ on ,octob] #a1 #bjbe1 & end+ on ,decemb] #ca1 #bjbe2 & 7,b7 9 clause 7ii71 by /rik+ ?r\gh #bjbd & ! portion ( fiscal ye> #bjbe beg9n+ on ,octob] #a1 #bjbd1 & end+ on ,m>* #ca1 #bjbe & ins]t+ ?r\gh #bjbe & ! portion ( fiscal ye> #bjbf beg9n+ on ,octob] #a1 #bjbe1 & end+ on ,decemb] #ca1 #bjbe4 7b7 ,implem5tation ,not)/&+ any o!r provision ( law1 ! ,secret>y ( ,heal? & ,human ,s]vices may implem5t ! am5dm5ts made by ?is section by program in/ruction or o!rwise4 #bjb4 ,ext5sion ( ! ,m$ic>e-dep5d5t hospital 7,,mdh7 program 7a7 ,9 g5]al ,section #ahhf7;d77#e77;,g7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e77;,g77 is am5d$-- 7#a7 9 clause 7i71 by /rik+ ,april #a1 #bjbe & ins]t+ ,janu>y #a1 #bjbf2 & 7#b7 9 clause 7ii77,,ii71 by /rik+ ,april #a1 #bjbe & ins]t+ ,janu>y #a1 #bjbf4 7b7 ,con=m+ am5dm5ts 7#a7 ,9 g5]al ,section #ahhf7;b77#c77;,d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieww7b77#c77;,d77 is am5d$-- 7,a7 9 ! matt] prec$+ clause 7i71 by /rik+ ,april #a1 #bjbe & ins]t+ ,janu>y #a1 #bjbf2 & 7,b7 9 clause 7iv71 by /rik+ ?r\gh fiscal ye> #bjbd & ! portion ( fiscal ye> #bjbe beg9n+ on ,octob] #a1 #bjbd1 & end+ on ,m>* #ca1 #bjbe & ins]t+ ?r\gh fiscal ye> #bjbe & ! portion ( fiscal ye> #bjbf beg9n+ on ,octob] #a1 #bjbe1 & end+ on ,decemb] #ca1 #bjbe4 7#b7 ,p]mitt+ hospitals to decl9e reclassification ,section #aceja7;e77#b7 ( ! ,omnibus ,budget ,reconciliation ,act ( #aiic 7#db ,u4,s4,c4 #acieww note7 is am5d$ by /rik+ ?r\gh fiscal ye> #bjbd1 or ! portion ( fiscal ye> #bjbe beg9n+ on ,octob] #a1 #bjbd1 & end+ on ,m>* #ca1 #bjbe & ins]t+ ?r\gh fiscal ye> #bjbe1 or ! portion ( fiscal ye> #bjbf beg9n+ on ,octob] #a1 #bjbe1 & end+ on ,decemb] #ca1 #bjbe4 #bjc4 ,ext5sion ( add-on paym5ts = ambulance s]vices ,section #ahcd7l7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7l77 is am5d$-- 7#a7 9 p>agraph 7#ab77;,a71 by /rik+ ,april #a1 #bjbe & ins]t+ ,janu>y #a1 #bjbg2 & 7#b7 9 p>agraph 7#ac71 by /rik+ ,april #a1 #bjbe ea* place x appe>s & ins]t+ ,janu>y #a1 #bjbg 9 ea* su* place4 #bjd4 ,ext5d+ inc5tive paym5ts = p>ticipation 9 eligible alt]native paym5t models 7a7 ,9 g5]al ,section #ahcc7z7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7z77 is am5d$-- 7#a7 9 p>agraph 7#a77;,a7-- 7,a7 by /rik+ ) #bjbf & ins]t+ ) #bjbg2 & 7,b7 by ins]t+ 1 or1 ) respect to #bjbg1 #c4ec p]c5t aft] #a4hh p]c5t2 7#b7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,b7-- 7i7 9 ! head+1 by /rik+ #bjbf & ins]t+ #bjbg2 & 7ii7 9 ! matt] prec$+ clause 7i71 by /rik+ #bjbf & ins]t+ #bjbg2 7,b7 9 subp>agraph 7,c7-- 7i7 9 ! head+1 by /rik+ #bjbg & ins]t+ #bjbh2 & 7ii7 9 ! matt] prec$+ clause 7i71 by /rik+ #bjbg & ins]t+ #bjbh2 & 7,c7 9 subp>agraph 7,d71 by /rik+ & #bjbf & ins]t+ #bjbf1 & #bjbg2 & 7#c7 9 p>agraph 7#d77;,b71 by ins]t+ or1 ) respect to #bjbg1 #c4ec p]c5t aft] #a4hh p]c5t4 7b7 ,con=m+ am5dm5ts ,section #ahdh7q77#a77;,c77iii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7q77#a77;,c77iii77 is am5d$-- 7#a7 9 subclause 7,,ii71 by /rik+ #bjbf & ins]t+ #bjbg2 & 7#b7 9 subclause 7,,iii71 by /rik+ #bjbg & ins]t+ #bjbh4 #bje4 ,tempor>y paym5t increase "u ! ,m$ic>e physician fee s*$ule to acc\nt = exceptional circum/ances 7a7 ,9 g5]al ,section #ahdh7t77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7t77#a77 is am5d$-- 7#a7 9 subp>agraph 7,d71 by /rik+ & at ! end2 7#b7 9 subp>agraph 7,e71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+ new subp>agraph3 7,f7 su* s]vices furni%$ on or aft] ,m>* #ae1 #bjbe1 & be=e ,janu>y #a1 #bjbf1 by #c4ecge p]c5t4 4 7b7 ,con=m+ am5dm5t ,section #ahdh7;c77#b77;,b77iv77,v7 is am5d$ by /rik+ or #bjbd & ins]t+ #bjbd1 or #bjbe4 #bjf4 ,ext5sion ( fund+ = quality measure endorsem5t1 input1 & selection ,section #ahij7;d77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;aaa7d77#b77 is am5d$-- 7#a7 9 ! fir/ s5t5ce-- 7,a7 by /rik+ #aa1jcj1jjj & ins]t+ #ad1jjj1jjj2 & 7,b7 by /rik+ ,m>* #ca1 #bjbe & ins]t+ ,decemb] #ca1 #bjbe2 & 7#b7 9 ! ?ird s5t5ce1 by /rik+ ,m>* #ca1 #bjbe & ins]t+ ,decemb] #ca1 #bjbe4 #bjg4 ,ext5sion ( fund+ outrea* & assi/ance = l[-income programs 7a7 ,/ate heal? insurance assi/ance programs ,subsection 7a77#a77;,b7 ( section #aai ( ! ,m$ic>e ,improvem5ts = ,pati5ts & ,provid]s ,act ( #bjjh 7#db ,u4,s4,c4 #acie;b-#c note7 is am5d$-- 7#a7 9 clause 7xiii71 by /rik+ & at ! end2 7#b7 9 clause 7xiv71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7#c7 by ins]t+ aft] clause 7xiv7 ! foll[+ new clause3 7xv7 = ! p]iod beg9n+ on ,april #a1 #bjbe1 & end+ on ,decemb] #ca1 #bjbf1 #bf1bej1jjj4 4 7b7 ,area ag5cies on ag+ ,subsection 7b77#a77;,b7 ( su* section #aai is am5d$-- 7#a7 9 clause 7xiii71 by /rik+ & at ! end2 7#b7 9 clause 7xiv71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7#c7 by ins]t+ aft] clause 7xiv7 ! foll[+ new clause3 7xv7 = ! p]iod beg9n+ on ,april #a1 #bjbe1 & end+ on ,decemb] #ca1 #bjbf1 #bf1bej1jjj4 4 7c7 ,ag+ & disability res\rce c5t]s ,subsection 7c77#a77;,b7 ( su* section #aai is am5d$-- 7#a7 9 clause 7xiii71 by /rik+ & at ! end2 7#b7 9 clause 7xiv71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7#c7 by ins]t+ aft] clause 7xiv7 ! foll[+ new clause3 7xv7 = ! p]iod beg9n+ on ,april #a1 #bjbe1 & end+ on ,decemb] #ca1 #bjbf1 #g1gej1jjj4 4 7d7 ,coord9ation ( ef=ts ,to in=m old] ,am]icans ab\t b5efits available "u ,f$]al & ,/ate programs ,subsection 7d77#b7 ( su* section #aai is am5d$-- 7#a7 9 clause 7xiii71 by /rik+ & at ! end2 7#b7 9 clause 7xiv71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7#c7 by ins]t+ aft] clause 7xiv7 ! foll[+ new clause3 7xv7 = ! p]iod beg9n+ on ,april #a1 #bjbe1 & end+ on ,decemb] #ca1 #bjbf1 #bf1bej1jjj4 4 #bjh4 ,ext5sion ( ! "w geographic index floor ,section #ahdh7;e77#a77;,e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;e77#a77;,e77 is am5d$ by /rik+ ,april #a1 #bjbe & ins]t+ ,janu>y #a1 #bjbf4 #bji4 ,ext5sion ( c]ta9 teleheal? flexibilities 7a7 ,remov+ geographic requirem5ts & exp&+ orig9at+ sites = teleheal? s]vices ,section #ahcd7m7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77 is am5d$-- 7#a7 9 p>agraph 7#b77;,b77iii71 by /rik+ end+ ,m>* #ca1 #bjbe & ins]t+ end+ ,decemb] #ca1 #bjbf2 & 7#b7 9 p>agraph 7#d77;,c77iii71 by /rik+ end+ on ,m>* #ca1 #bjbe & ins]t+ end+ on ,decemb] #ca1 #bjbf4 7b7 ,exp&+ practition]s eligible ,to furni% teleheal? s]vices ,section #ahcd7m77#d77;,e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#d77;,e77 is am5d$ by /rik+ end+ on ,m>* #ca1 #bjbe & ins]t+ end+ on ,decemb] #ca1 #bjbf4 7c7 ,ext5d+ teleheal? s]vices = f$]ally qualifi$ heal? c5t]s & rural heal? cl9ics ,section #ahcd7m77#h7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#h77 is am5d$-- 7#a7 9 subp>agraph 7,a71 by /rik+ end+ on ,m>* #ca1 #bjbe & ins]t+ end+ on ,decemb] #ca1 #bjbf2 7#b7 9 subp>agraph 7,b7-- 7,a7 9 ! subp>agraph head+1 by ins]t+ be=e ,april #a1 #bjbe aft] rule2 7,b7 9 clause 7i71 by /rik+ dur+ ! p]iods = :i* subp>agraph 7,a7 applies & ins]t+ be=e ,april #a1 #bjbe2 & 7,c7 9 clause 7ii71 by ins]t+ furni%$ to an eligible teleheal? individual be=e ,april #a1 #bjbe aft] teleheal? s]vices2 & 7#c7 by add+ at ! end ! foll[+ new subp>agraph3 7,c7 ,paym5t rule = portion ( #bjbe & #bjbf 7i7 ,9 g5]al ,a teleheal? s]vice furni%$ to an eligible teleheal? individual by a ,f$]ally qualifi$ heal? c5t] or rural heal? cl9ic on or aft] ,april #a1 #bjbe1 & be=e ,janu>y #a1 #bjbg1 %all be paid z a ,f$]ally qualifi$ heal? c5t] s]vice or rural heal? cl9ic s]vice 7z applicable7 "u ! prospective paym5t sy/em e/abli%$ "u section #ahcd7o7 or ! me?odology = all-inclusive rates e/abli%$ "u section #ahcc7;a77#c71 respectively4 7ii7 ,treatm5t ( co/s ,co/s associat$ ) ! furni%+ ( teleheal? s]vices by a ,f$]ally qualifi$ heal? c5t] or rural heal? cl9ic on or aft] ,april #a1 #bjbe1 & be=e ,janu>y #a1 #bjbg1 %all be consid]$ all[able co/s = purposes ( ! prospective paym5t sy/em e/abli%$ "u section #ahcd7o7 & ! me?odology = all-inclusive rates e/abli%$ "u section #ahcc7;a77#c71 z applicable4 7iii7 ,requir+ modifi]s ,n lat] ?an ,july #a1 #bjbe1 ! ,secret>y %all e/abli% requirem5ts to include #a or m codes or modifi]s1 z det]m9$ appropriate by ! ,secret>y1 9 ! case ( claims = teleheal? s]vices furni%$ to an eligible teleheal? individual by a ,f$]ally qualifi$ heal? c5t] or rural heal? cl9ic4 4 7d7 ,delay+ ! 9-,p]son requirem5ts "u ,m$ic>e = m5tal heal? s]vices furni%$ ?r\gh teleheal? & telecommunications te*nology 7#a7 ,delay 9 requirem5ts = m5tal heal? s]vices furni%$ ?r\gh teleheal? ,section #ahcd7m77#g77;,b77i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#g77;,b77i77 is am5d$1 9 ! matt] prec$+ subclause 7,i71 by /rik+ ,april #a1 #bjbe & ins]t+ ,janu>y #a1 #bjbg4 7#b7 ,m5tal heal? visits furni%$ by rural heal? cl9ics ,section #ahcd7y77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7y77#b77 is am5d$ by /rik+ ,april #a1 #bjbe & ins]t+ ,janu>y #a1 #bjbg4 7#c7 ,m5tal heal? visits furni%$ by ,f$]ally qualifi$ heal? c5t]s ,section #ahcd7o77#d77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7o77#d77;,b77 is am5d$ by /rik+ ,april #a1 #bjbe & ins]t+ ,janu>y #a1 #bjbg4 7e7 ,all[+ = ! furni%+ ( audio-,only teleheal? s]vices ,section #ahcd7m77#i7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#i77 is am5d$ by /rik+ end+ on ,m>* #ca1 #bjbe & ins]t+ end+ on ,decemb] #ca1 #bjbf4 7f7 ,ext5d+ use ( teleheal? ,to conduct face-to-,face enc\nt] prior to rec]tification ( eligibility = hospice c>e ,section #ahad7;a77#g77;,d77i77,,ii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;f7a77#g77;,d77i77,,ii77 is am5d$-- 7#a7 by /rik+ end+ on ,m>* #ca1 #bjbe & ins]t+ end+ on ,decemb] #ca1 #bjbf2 & 7#b7 by ins]t+ 1 except t ?is subclause %all n apply 9 ! case ( su* an enc\nt] ) an individual occurr+ on or aft] ,april #a1 #bjbe1 if su* individual is locat$ 9 an area t is subject to a moratorium on ! enrollm5t ( hospice programs "u ?is title pursuant to section #ahff7;j77#g71 if su* individual is receiv+ hospice c>e f a provid] t is subject to enhanc$ ov]sight "u ?is title pursuant to section #ahff7;j77#c71 or if su* enc\nt] is p]=m$ by a hospice physician or nurse practition] :o is n enroll$ "u section #ahff7;j7 & is n an opt-out physician or practition] 7z def9$ 9 section #ahjb7;b77#f77;,d77 be=e ! semicolon4 7g7 ,requir+ modifi]s = teleheal? s]vices 9 c]ta9 in/ances ,section #ahcd7m7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#aj7 ,requir$ use ( modifi]s 9 c]ta9 in/ances ,n lat] ?an ,janu>y #a1 #bjbf1 ! ,secret>y %all e/abli% requirem5ts to include #a or m codes or modifi]s1 z det]m9$ appropriate by ! ,secret>y1 9 ! case (-- 7,a7 claims = teleheal? s]vices "u ?is subsection t are furni%$ ?r\gh a teleheal? virtual plat=m-- 7i7 by a physician or practition] t contracts ) an entity t owns su* virtual plat=m2 or 7ii7 = :i* a physician or practition] has a paym5t arrangem5t ) an entity = use ( su* virtual plat=m2 & 7,b7 claims = teleheal? s]vices "u ?is subsection t are furni%$ incid5t to a physician's or practition]'s pr(essional s]vice4 4 7h7 ,program in/ruction au?ority ,! ,secret>y ( ,heal? & ,human ,s]vices may implem5t ! am5dm5ts made by ?is section ?r\gh program in/ruction or o!rwise4 #baj4 ,requir+ modifi] = use ( teleheal? to conduct face-to-face enc\nt] prior to rec]tification ( eligibility = hospice c>e ,section #ahad7;a77#g77;,d77i77,,ii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;f7a77#g77;,d77i77,,ii771 z am5d$ by section #bji7;f71 is fur!r am5d$ by ins]t+ 1 b only if1 9 ! case ( su* an enc\nt] occurr+ on or aft] ,janu>y #a1 #bjbf1 any hospice claim includes #a or m modifi]s or codes 7z specifi$ by ! ,secret>y7 to indicate t su* enc\nt] 0 conduct$ via teleheal? aft] z det]m9$ appropriate by ! ,secret>y4 #baa4 ,ext5d+ acute hospital c>e at home waiv] flexibilities ,section #ahff;,g ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;cc-#g7 is am5d$-- 7#a7 9 ! section head+1 by ins]t+ ! ,?omas ,r4 ,c>p]1 ,tim ,scott1 ,brad ,r4 ,w5/rup1 ,d4,p4,m41 & ,e>l ,blum5au] aft] ,ext5sion (2 7#b7 9 subsection 7a7-- 7,a7 9 p>agraph 7#a7-- 7i7 by /rik+ ,m>* #ca1 #bjbe & ins]t+ ,decemb] #ca1 #bjbi2 & 7ii7 by /rik+ 9 ! ,acute ,hospital ,c>e at ,home initiative ( ! ,secret>y & ins]t+ 9 ! ,?omas ,r4 ,c>p]1 ,tim ,scott1 ,brad ,r4 ,w5/rup1 ,d4,p4,m41 & ,e>l ,blum5au] ,acute ,hospital ,c>e at ,home initiative ( ! ,secret>y 79 ?is section ref]r$ to z ! ,acute ,hospital ,c>e at ,home initiative72 7,b7 9 p>agraph 7#b71 by /rik+ ( ! ,secret>y2 & 7,c7 9 p>agraph 7#c77;,e71 by add+ at ! end ! foll[+ new flu% s5t5ce3 ,! ,secret>y may require t su* data & in=mation be submitt$ ?r\gh a hospital's co/ report1 ?r\gh su* survey in/rum5ts z ! ,secret>y may develop1 ?r\gh m$ical record in=mation1 or ?r\gh su* o!r means z ! ,secret>y det]m9es appropriate4 2 7#c7 9 subsection 7b7-- 7,a7 9 ! subsection head+1 by /rik+ ,/udy & ins]t+ ,initial /udy2 7,b7 9 p>agraph 7#a77;,a71 by /rik+ ( ! ,secret>y2 & 7,c7 9 p>agraph 7#c71 by ins]t+ or subsection 7c7 be=e ! p]iod at ! end2 7#d7 by r$esignat+ subsections 7c7 & 7d7 z subsections 7d7 & 7e71 respectively2 & 7#e7 by ins]t+ aft] subsection 7b7 ! foll[+ new subsection3 7c7 ,subsequ5t /udy & report 7#a7 ,9 g5]al ,n lat] ?an ,septemb] #cj1 #bjbh1 ! ,secret>y %all conduct a /udy to-- 7,a7 analyze1 to ! ext5t practicable1 ! crit]ia e/abli%$ by hospitals "u ! ,acute ,hospital ,c>e at ,home initiative to det]m9e :i* individuals may be furni%$ s]vices "u su* initiative2 & 7,b7 analyze & comp>e 7bo? )9 & betwe5 hospitals p>ticipat+ 9 ! initiative1 & relative to comp>able hospitals t d n p>ticipate 9 ! initiative1 = relevant p>amet]s su* z diagnosis-relat$ gr\ps7-- 7i7 quality ( c>e furni%$ to individuals ) simil> conditions & *>act]i/ics 9 ! inpati5t sett+ & ?r\gh ! ,acute ,hospital ,c>e at ,home initiative1 includ+ heal? outcomes1 hospital readmission rates 7includ+ readmissions bo? )9 & beyond #cj days po/-dis*>ge71 hospital mortality rates1 l5g? ( /ay1 infection rates1 composition ( c>e team 7includ+ ! types ( labor us$1 su* z contract$ labor71 ! ratio ( nurs+ /aff1 transf]s f ! hospital to ! home1 transf]s f ! home to ! hospital 7includ+ ! tim+1 frequ5cy1 & causes ( su* transf]s71 transf]s & dis*>ges to po/-acute c>e sett+s 7includ+ ! tim+1 frequ5cy1 & causes ( su* transf]s & dis*>ges71 & pati5t & c>egiv] exp]i5ce ( c>e2 7ii7 cl9ical conditions treat$ & diagnosis-relat$ gr\ps ( dis*>ges f inpati5t sett+s relative to dis*>ges f ! ,acute ,hospital ,c>e at ,home initiative2 7iii7 co/s incurr$ by ! hospital = furni%+ c>e 9 inpati5t sett+s relative to co/s incurr$ by ! hospital = furni%+ c>e ?r\gh ! ,acute ,hospital ,c>e at ,home initiative1 includ+ co/s relat+ to /aff+1 equipm5t1 food1 prescriptions1 & o!r s]vices1 z det]m9$ by ! ,secret>y2 7iv7 ! quantity1 mix1 & int5sity ( s]vices 7su* z 9-p]son visits & virtual contacts ) pati5ts & ! int5sity ( su* s]vices7 furni%$ 9 inpati5t sett+s relative to ! ,acute ,hospital ,c>e at ,home initiative1 &1 to ! ext5t practicable1 ! nature & ext5t ( family or c>egiv] involvem5t2 7v7 socioeconomic in=mation on individuals treat$ 9 comp>able inpati5t sett+s relative to ! initiative1 includ+ racial & e?nic data1 income1 h\s+1 geographic proximity to ! brick-&-mort> facility & :e!r su* individuals are dually eligible = b5efits "u ?is title & title ,,xix2 & 7vi7 ! quality ( c>e1 outcomes1 co/s1 quantity & int5sity ( s]vices1 & o!r relevant metrics betwe5 individuals :o ent]$ into ! ,acute ,hospital ,c>e at ,home initiative directly f an em]g5cy dep>tm5t comp>$ ) individuals :o ent]$ into ! ,acute ,hospital ,c>e at ,home initiative directly f an exi/+ inpati5t /ay 9 a hospital4 7#b7 ,selection bias ,9 conduct+ ! /udy "u p>agraph 7#a71 ! ,secret>y %all1 to ! ext5t practicable1 analyze & comp>e individuals :o p>ticipate & d n p>ticipate 9 ! initiative controll+ = selection bias or o!r factors t may impact ! reliability ( data4 7#c7 ,report ,n lat] ?an ,septemb] #cj1 #bjbh1 ! ,secret>y ( ,heal? & ,human ,s]vices %all po/ on a website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices a report on ! /udy conduct$ "u p>agraph 7#a74 7#d7 ,fund+ ,9 addition to am\nts o!rwise available1 !re is appropriat$ to ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices ,program ,managem5t ,acc\nt = fiscal ye> #bjbf1 out ( any am\nts 9 ! ,treasury n o!rwise appropriat$1 #f1jjj1jjj1 respectively1 to rema9 available until exp5d$1 = purposes ( c>ry+ out ?is section4 4 #bab4 ,enhanc+ c]ta9 program integrity requirem5ts = ,,dme "u ,m$ic>e 7a7 ,durable m$ical equipm5t 7#a7 ,9 g5]al ,section #ahcd7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7a77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#bc7 ,ma/] ,li/ inclusion & claim review = c]ta9 items 7,a7 ,ma/] ,li/ inclusion ,beg9n+ ,janu>y #a1 #bjbh1 = purposes ( ! ,ma/] ,li/ describ$ 9 section #dad4bcd7;b7 ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulation71 an item = :i* paym5t may be made "u ?is subsection %all be treat$ z hav+ ab]rant bill+ patt]ns 7z su* t]m is us$ = purposes ( su* section7 if ! ,secret>y det]m9es t1 )\t explanatory contribut+ factors 7su* z furni%+ em]g5t c>e s]vices71 a sub/antial numb] ( claims = su* items "u ?is subsection are = su* items ord]$ by a physician or practition] :o has n previ\sly 7dur+ a p]iod ( n less ?an #bd mon?s1 z e/abli%$ by ! ,secret>y7 furni%$ to ! individual involv$ any item or s]vice = :i* paym5t may be made "u ?is title4 7,b7 ,claim review ,) respect to items furni%$ on or aft] ,janu>y #a1 #bjbh1 t are includ$ on ! ,ma/] ,li/ pursuant to subp>agraph 7,a71 if su* an item is n subject to a det]m9ation ( cov]age 9 advance pursuant to p>agraph 7#ae77;,c71 ! ,secret>y may conduct prepaym5t review ( claims = paym5t = su* item4 4 7#b7 ,con=m+ am5dm5t = pro/hetic devices1 or?otics1 & pro/hetics ,section #ahcd7;h77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h77#c77 is am5d$ by ins]t+ 1 & p>agraph 7#bc7 ( subsection 7a7 %all apply to pro/hetic devices1 or?otics1 & pro/hetics 9 ! same mann] z su* provision applies to items = :i* paym5t may be made "u su* subsection be=e ! p]iod at ! end4 7b7 ,report on id5tify+ cl9ical diagno/ic laboratory te/s at high risk = fraud & effective mitigation measures ,n lat] ?an ,janu>y #a1 #bjbf1 ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all submit to ,congress a report assess+ fraud risks relat+ to claims = cl9ical diagno/ic laboratory te/s = :i* paym5t may be made "u section #ahcd;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem-#a7 & effective tools = r$uc+ su* fraudul5t claims4 ,! report may include in=mation reg>d+-- 7#a7 :i*1 if any1 cl9ical diagno/ic laboratory te/s are id5tifi$ z be+ at high risk ( fraudul5t claims1 & an analysis ( ! factors t contribute to su* risk2 7#b7 ) respect to a cl9ical diagno/ic laboratory te/ id5tifi$ "u p>agraph 7#a7 z be+ at high risk ( fraudul5t claims-- 7,a7 ! am\nt payable "u su* section #ahcd;,a ) respect to su* te/2 7,b7 ! numb] ( su* te/s furni%$ to individuals enroll$ "u "p ,b ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;j et seq472 7,c7 :e!r an ord] = su* a te/ 0 m likely to come f a provid] ) :om ! individual involv$ did n h a prior relation%ip1 z det]m9$ on ! basis ( prior paym5t exp]i5ce2 & 7,d7 ! frequ5cy ) :i* a claim = paym5t "u su* section #ahcd;,a includ$ ! paym5t modifi] id5tifi$ by code #ei or #ia2 & 7#c7 sugge/$ /rategies = r$uc+ ! numb] ( fraudul5t claims made ) respect to te/s s id5tifi$ z be+ at high risk1 includ+-- 7,a7 an analysis ( :e!r ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices c detect ab]rant bill+ patt]ns ) respect to su* te/s 9 a timely mann]2 7,b7 any /rategies = id5tify+ & monitor+ ! provid]s :o are outli]s ) respect to ! numb] ( su* te/s t su* provid]s ord]2 & 7,c7 t>get$ education ef=ts to mitigate improp] bill+ = su* te/s2 & 7#d7 su* o!r in=mation z ! ,inspector ,g5]al det]m9es appropriate4 #bac4 ,guidance on furni%+ s]vices via teleheal? to individuals ) limit$ ,engli% pr(ici5cy 7a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is section1 ! ,secret>y ( ,heal? & ,human ,s]vices1 9 consultation ) #a or m entities f ea* ( ! categories describ$ 9 p>agraphs 7#a7 ?r\gh 7#g7 ( subsection 7b71 %all issue & dissem9ate1 or update & revise z applicable1 guidance = ! entities describ$ 9 su* subsection on ! foll[+3 7#a7 ,be/ practices on facilitat+ & integrat+ use ( int]pret]s dur+ a telem$ic9e appo9tm5t4 7#b7 ,be/ practices on provid+ accessible in/ructions on h[ to access telecommunications sy/ems 7z su* t]m is us$ = purposes ( section #ahcd7m7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77 = individuals ) limit$ ,engli% pr(ici5cy4 7#c7 ,be/ practices on improv+ access to digital pati5t portals = individuals ) limit$ ,engli% pr(ici5cy4 7#d7 ,be/ practices on integrat+ ! use ( video plat=ms t enable multi-p]son video calls furni%$ via a telecommunications sy/em = purposes ( provid+ int]pretation dur+ a telem$ic9e appo9tm5t = an individual ) limit$ ,engli% pr(ici5cy4 7#e7 ,be/ practices = provid+ pati5t mat]ials1 communications1 & in/ructions 9 multiple languages1 includ+ text message appo9tm5t rem9d]s & prescription in=mation4 7b7 ,entities describ$ ,= purposes ( subsection 7a71 an entity describ$ 9 ?is subsection is an entity 9 #a or m ( ! foll[+ categories3 7#a7 ,heal? in=mation te*nology s]vice provid]s1 includ+-- 7,a7 electronic m$ical record companies2 7,b7 remote pati5t monitor+ companies2 & 7,c7 teleheal? or mobile heal? v5dors & companies4 7#b7 ,heal? c>e provid]s1 includ+-- 7,a7 physicians2 & 7,b7 hospitals4 7#c7 ,heal? insur]s4 7#d7 ,language s]vice companies4 7#e7 ,int]pret] or translator pr(essional associations4 7#f7 ,heal? & language s]vices quality c]tification organizations4 7#g7 ,pati5t & consum] advocates1 includ+ su* advocates t "w ) individuals ) limit$ ,engli% pr(ici5cy4 #bad4 ,9-home c>diopulmon>y rehabilitation flexibilities 7a7 ,9 g5]al ,section #ahfa7;eee77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7eee77#b77 is am5d$-- 7#a7 9 subp>agraph 7,a77ii71 by ins]t+ 7includ+1 ) respect to items & s]vices furni%$ ?r\gh audio & video real-"t communications te*nology 7exclud+ audio-only7 on or aft] ,april #a1 #bjbe1 & be=e ,janu>y #a1 #bjbg1 9 ! home ( an individual :o is an outpati5t ( ! hospital7 aft] outpati5t basis2 & 7#b7 9 subp>agraph 7,b71 by ins]t+ 7includ+1 ) respect to items & s]vices furni%$ ?r\gh audio & video real-"t communications te*nology on or aft] ,april #a1 #bjbe1 & be=e ,janu>y #a1 #bjbg1 ! virtual pres5ce ( su* physician1 physician assi/ant1 nurse practition]1 or cl9ical nurse speciali/7 aft] "u ! program4 7b7 ,program in/ruction au?ority ,not)/&+ any o!r provision ( law1 ! ,secret>y ( ,heal? & ,human ,s]vices may implem5t ! am5dm5ts made by ?is section by program in/ruction or o!rwise4 #bae4 ,inclusion ( virtual diabetes prev5tion program suppli]s 9 ,,mdpp ,exp&$ ,model 7a7 ,9 g5]al ,n lat] ?an ,janu>y #a1 #bjbf1 ! ,secret>y %all revise ! regulations "u p>ts #daj & #dbd ( title #db1 ,code ( ,f$]al ,regulations1 to provide t1 = ! p]iod beg9n+ ,janu>y #a1 #bjbf1 & end+ ,decemb] #ca1 #bjcj-- 7#a7 an entity may p>ticipate 9 ! ,,mdpp by (f]+ only onl9e ,,mdpp s]vices via syn*ron\s or asyn*ron\s te*nology or telecommunications if su* entity meets ! conditions = enrollm5t z an ,,mdpp suppli] 7z specifi$ 9 section #dbd4bje7;b7 ( title #db1 ,code ( ,f$]al ,regulations 7or a successor regulation772 7#b7 if an entity p>ticipates 9 ! ,,mdpp 9 ! mann] describ$ 9 p>agraph 7#a7-- 7,a7 ! adm9i/rative location ( su* entity %all be ! address ( ! entity on file "u ! ,diabetes ,prev5tion ,recognition ,program2 & 7,b7 9 ! case ( onl9e ,,mdpp s]vices furni%$ by su* entity to an ,,mdpp b5efici>y :o 0 n locat$ 9 ! same ,/ate z ! entity at ! "t su* s]vices 7 furni%$1 ! entity %all n be prohibit$ f submitt+ a claim = paym5t = su* s]vices solely by reason ( ! location ( su* b5efici>y at su* "t2 & 7#c7 no limit is appli$ on ! numb] ( times an individual may enroll 9 ! ,,mdpp4 7b7 ,def9itions ,9 ?is section3 7#a7 ,,mdpp ,! t]m ,,mdpp means ! ,m$ic>e ,diabetes ,prev5tion ,program conduct$ "u section #aaae;,a ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acae;a71 z describ$ 9 ! f9al rule publi%$ 9 ! ,f$]al ,regi/] entitl$ ,m$ic>e & ,m$icaid ,programs2 ,,cy #bjbd ,paym5t ,policies ,"u ! ,physician ,fee ,s*$ule & ,o!r ,*anges to ,"p ,b ,paym5t & ,cov]age ,policies2 ,m$ic>e ,%>$ ,sav+s ,program ,requirem5ts2 ,m$ic>e ,advantage2 ,m$ic>e & ,m$icaid ,provid] & ,suppli] ,enrollm5t ,policies2 & ,basic ,heal? ,program 7#hh ,f$4 ,reg4 #ghhah 7,novemb] #af1 #bjbc77 7or a successor regulation74 7#b7 ,regulatory t]ms ,! t]ms ,diabetes ,prev5tion ,recognition ,program1 full ,,cdc ,,dprp recognition1 ,,mdpp b5efici>y1 ,,mdpp s]vices1 & ,,mdpp suppli] h ! mean+s giv5 ea* su* t]m 9 section #daj4gi7;b7 ( title #db1 ,code ( ,f$]al ,regulations4 7#c7 ,secret>y ,! t]m ,secret>y means ! ,secret>y ( ,heal? & ,human ,s]vices4 #baf4 ,m$ication-induc$ movem5t disord] outrea* & education ,n lat] ?an ,janu>y #a1 #bjbf1 ! ,secret>y %all use exi/+ communications me*anisms to provide education & outrea* to physicians & appropriate non-physician practition]s p>ticipat+ "u ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 ) respect to p]iodic scre5+ = m$ication-induc$ movem5t disord]s t are associat$ ) ! treatm5t ( m5tal heal? disord]s 9 at-risk pati5ts1 z well z res\rces relat$ to cl9ical guidel9es & be/ practices = furni%+ su* scre5+ s]vices ?r\gh teleheal?4 ,su* education & outrea* %all include in=mation on h[ to acc\nt = su* scre5+ s]vices 9 evaluation & managem5t code selection4 ,! ,secret>y %all1 to ! ext5t practicable1 seek input f relevant /akehold]s to in=m su* education & outrea*4 ,su* education & outrea* may also address o!r relevant scre5+ s]vices furni%$ ?r\gh teleheal?1 z ! ,secret>y det]m9es appropriate4 #bag4 ,report on we>able m$ical devices ,n lat] ?an #ah mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a te*nology assessm5t (1 & submit to ,congress a report on1 ! capabilities & limitations ( we>able m$ical devices us$ to support cl9ical decision-mak+4 ,su* report %all include a description (-- 7#a7 ! pot5tial = su* devices to accurately prescribe treatm5ts2 7#b7 an exam9ation ( ! b5efits & *all5ges ( artificial intellig5ce to augm5t su* capabilities2 & 7#c7 policy options to enhance ! b5efits & mitigate pot5tial *all5ges ( develop+ or us+ su* devices4 #bah4 ,ext5sion ( tempor>y inclusion ( au?oriz$ oral antiviral drugs z cov]$ "p ,d drugs ,section #ahfj;,d-#b7;e77#a77;,c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;e77#a77;,c77 is am5d$ by /rik+ ,m>* #ca1 #bjbe & ins]t+ ,decemb] #ca1 #bjbe4 #bai4 ,ext5sion ( adju/m5t to calculation ( hospice cap am\nt ,section #ahad7;i77#b77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;f7i77#b77;,b77 is am5d$-- 7#a7 9 clause 7ii71 by /rik+ #bjcc & ins]t+ #bjcd2 & 7#b7 9 clause 7iii71 by /rik+ #bjcc & ins]t+ #bjcd4 #bbj4 ,multiye> contract+ au?ority = ,med,p,a,c & ,,macpac ,section #cijd ( title #da1 ,unit$ ,/ates ,code1 is am5d$ by add+ at ! end ! foll[+ new subsections3 7i7 ,! ,m$ic>e ,paym5t ,advisory ,commission ,! ,m$ic>e ,paym5t ,advisory ,commission may use available funds to ent] into contracts = ! procurem5t ( sev]able s]vices = a p]iod t beg9s 9 "o fiscal ye> & ends 9 ! next fiscal ye> & may ent] into multiye> contracts = ! acquisition ( prop]ty & s]vices to ! same ext5t z executive ag5cies "u ! au?ority ( sections #cijb & #cijc ( ?is title4 7j7 ,! ,m$icaid & ,,*ip ,paym5t & ,access ,commission ,! ,m$icaid & ,,*ip ,paym5t & ,access ,commission may use available funds to ent] into contracts = ! procurem5t ( sev]able s]vices = a p]iod t beg9s 9 "o fiscal ye> & ends 9 ! next fiscal ye> & may ent] into multiye> contracts = ! acquisition ( prop]ty & s]vices to ! same ext5t z executive ag5cies "u ! au?ority ( sections #cijb & #cijc ( ?is title4 4 #bba4 ,contract+ p>ity = ,med,p,a,c & ,,macpac ,9 fiscal ye> #bjbe & !reaft]1 = all contracts = goods & s]vices to :i* ! ,m$ic>e & ,paym5t ,advisory ,commission or ! ,m$icaid & ,,*ip ,paym5t & ,access ,commission is a p>ty1 ! foll[+ ,f$]al ,acquisition ,regulation 7,,f>7 clauses w apply3 ,,f> #eb4bcb-ci & ,,f> #eb4bcc-d 7or a successor clause74 #bbb4 ,adju/m5ts to ,m$ic>e "p ,d co/-%>+ r$uctions = l[-income individuals ,section #ahfj;,d-#ad7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77 is am5d$-- 7#a7 9 p>agraph 7#a77;,d77ii71 by /rik+ t does n exce$ #a = & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ t does n exce$-- 7,i7 = a plan ye> be=e #bjbg-- 7aa7 = a g5]ic drug or a pref]r$ drug t is a multiple s\rce drug 7z def9$ 9 section #aibg7k77#g77;,a77i771 #a or1 if less1 ! copaym5t am\nt applicable to an individual "u clause 7iii72 & 7bb7 = any o!r drug1 #c or1 if less1 ! copaym5t am\nt applicable to an individual "u clause 7iii72 & 7,,ii7 = plan ye> #bjbg & ea* subsequ5t plan ye>-- 7aa7 = a g5]ic drug1 #j2 7bb7 = a pref]r$ drug t is a multiple s\rce drug 7z def9$ 9 section #aibg7k77#g77;,a77i771 ! doll> am\nt appli$ "u ?is clause = su* a drug = ! prec$+ plan ye>1 increas$ by ! annual p]c5tage increase 9 ! consum] price index 7all items2 ,u4,s4 city av]age7 z ( ,septemb] ( su* prec$+ ye>1 or1 if less1 ! copaym5t am\nt applicable to an individual "u clause 7iii72 & 7cc7 = a drug n describ$ 9 ei!r item 7aa7 or 7bb71 ! doll> am\nt appli$ "u ?is clause = su* a drug = ! prec$+ plan ye>1 increas$ 9 ! mann] specifi$ 9 item 7bb71 or1 if less1 ! copaym5t am\nt applicable to an individual "u clause 7iii74 ,any am\nt e/abli%$ "u item 7bb7 or 7cc7 ( subclause 7,,ii71 t is bas$ on an increase ( #a or #c1 t is n a multiple ( #e c5ts or #aj c5ts1 respectively1 %all be r\nd$ to ! ne>e/ multiple ( #e c5ts or #aj c5ts1 respectively4 2 & 7#b7 9 p>agraph 7#d77;,a77ii71 by ins]t+ 7be=e #bjbg7 aft] a subsequ5t ye>4 #bbc4 ,requir+ ,enhanc$ & ,accurate ,li/s ( 7,,real7 ,heal? ,provid]s ,act 7a7 ,9 g5]al ,section #aheb7;c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bb7;c77 is am5d$-- 7#a7 9 p>agraph 7#a77;,c7-- 7,a7 by /rik+ plan1 & any & ins]t+ plan1 any2 & 7,b7 by ins]t+ ! foll[+ be=e ! p]iod at ! end3 1 &1 9 ! case ( a specifi$ ,,ma plan 7z def9$ 9 p>agraph 7#c77;,c771 = plan ye> #bjbg & subsequ5t plan ye>s1 ! in=mation describ$ 9 p>agraph 7#c77;,b72 & 7#b7 by add+ at ! end ! foll[+ new p>agraph3 7#c7 ,provid] directory accuracy 7,a7 ,9 g5]al ,= plan ye> #bjbg & subsequ5t plan ye>s1 ea* ,,ma organization (f]+ a specifi$ ,,ma plan 7z def9$ 9 subp>agraph 7,c77 %all1 = ea* su* plan (f]$ by ! organization-- 7i7 ma9ta91 on a publicly available int]net website1 an accurate provid] directory t includes ! in=mation describ$ 9 subp>agraph 7,b72 7ii7 n less frequ5tly ?an once e #ij days 7or1 9 ! case ( a hospital or any o!r facility det]m9$ appropriate by ! ,secret>y1 at a less] frequ5cy specifi$ by ! ,secret>y b 9 no case less frequ5tly ?an once e #ab mon?s71 v]ify ! provid] directory in=mation ( ea* provid] li/$ 9 su* directory &1 if applicable1 update su* provid] directory in=mation2 7iii7 if ! organization is unable to v]ify su* in=mation ) respect to a provid]1 include 9 su* directory an indication t ! in=mation ( su* provid] may n be up-to-date2 & 7iv7 remove a provid] f su* directory )9 #e bus9ess days if ! organization det]m9es t ! provid] is no long] a provid] p>ticipat+ 9 ! network ( su* plan4 7,b7 ,provid] directory in=mation ,! in=mation describ$ 9 ?is subp>agraph is in=mation enrollees may ne$ to access cov]$ b5efits f a provid] ) :i* su* organization (f]+ su* plan has an agreem5t = furni%+ items & s]vices cov]$ "u su* plan su* z "n1 specialty1 contact in=mation1 prim>y (fice or facility address1 :e!r ! provid] is accept+ new pati5ts1 accommodations = p ) disabilities1 cultural & l+ui/ic capabilities1 & teleheal? capabilities4 7,c7 ,specifi$ ,,ma plan ,9 ?is p>agraph1 ! t]m specifi$ ,,ma plan means-- 7i7 a network-bas$ plan 7z def9$ 9 subsection 7d77#e77;,c772 or 7ii7 a ,m$ic>e ,advantage private fee-=-s]vice plan 7z def9$ 9 section #ahei7;b77#b77 t meets ! access /&>ds "u subsection 7d77#d71 9 :ole or 9 "p1 ?r\gh ent]+ into contracts or agreem5ts z provid$ = "u subp>agraph 7,b7 ( su* subsection4 4 7b7 ,acc\ntability = provid] directory accuracy 7#a7 ,co/ ,%>+ = ,s]vices ,furni%$ ,bas$ on ,reliance on ,incorrect ,provid] directory ,in=mation ,section #aheb7;d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bb7;d77 is am5d$-- 7,a7 9 p>agraph 7#a77;,c7-- 7i7 9 clause 7ii71 by /rik+ or at ! end2 7ii7 9 clause 7iii71 by /rik+ ! semicolon at ! end & ins]t+ 1 or2 & 7iii7 by add+ at ! end ! foll[+ new clause3 7iv7 ! s]vices are furni%$ by a provid] t is n p>ticipat+ 9 ! network ( a specifi$ ,,ma plan 7z def9$ 9 subsection 7c77#c77;,c77 b is li/$ 9 ! provid] directory ( su* plan on ! date on :i* ! appo9tm5t is made1 z describ$ 9 p>agraph 7#g77;,a72 2 & 7,b7 by add+ at ! end ! foll[+ new p>agraph3 7#g7 ,co/ %>+ = s]vices furni%$ bas$ on reliance on incorrect provid] directory in=mation 7,a7 ,9 g5]al ,= plan ye> #bjbg & subsequ5t plan ye>s1 if an enrollee is furni%$ an item or s]vice by a provid] t is n p>ticipat+ 9 ! network ( a specifi$ ,,ma plan 7z def9$ 9 subsection 7c77#c77;,c77 b is li/$ 9 ! provid] directory ( su* plan 7z requir$ to be provid$ to an enrollee pursuant to subsection 7c77#a77;,c77 on ! date on :i* ! appo9tm5t is made1 & if su* item or s]vice w\ld o!rwise be cov]$ "u su* plan if furni%$ by a provid] t is p>ticipat+ 9 ! network ( su* plan1 ! ,,ma organization (f]+ su* plan %all ensure t ! enrollee is only responsible = ! less] (-- 7i7 ! am\nt ( co/ %>+ t w\ld apply if su* provid] _h be5 p>ticipat+ 9 ! network ( su* plan2 or 7ii7 ! am\nt ( co/ %>+ t w\ld o!rwise apply 7)\t reg>d to ?is subp>agraph74 7,b7 ,notification requirem5t ,= plan ye> #bjbg & subsequ5t plan ye>s1 ea* ,,ma organization t (f]s a specifi$ ,,ma plan %all-- 7i7 notify enrollees ( _! co/-%>+ protections "u ?is p>agraph & make su* notifications1 to ! ext5t practicable1 by n lat] ?an ! fir/ day ( an annual1 coord9at$ election p]iod "u section #ahea7;e77#c7 ) respect to a ye>2 7ii7 include in=mation reg>d+ su* co/-%>+ protections 9 ! provid] directory ( ea* specifi$ ,,ma plan (f]$ by ! ,,ma organization42 & 7iii7 notify enrollees ( _! co/-%>+ protections "u ?is p>agraph 9 an explanation ( b5efits4 4 7#b7 ,requir$ provid] directory accuracy analysis & reports 7,a7 ,9 g5]al ,section #aheg7;e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;e77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#f7 ,provid] directory accuracy analysis & reports 7,a7 ,9 g5]al ,beg9n+ ) plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbg1 subject to subp>agraph 7,c71 a contract "u ?is section ) an ,,ma organization %all require ! organization1 = ea* specifi$ ,,ma plan 7z def9$ 9 section #aheb7;c77#c77;,c77 (f]$ by ! organization to annually d ! foll[+3 7i7 ,conduct an analysis e/imat+ ! accuracy ( ! provid] directory in=mation ( su* plan us+ a r&om sample ( provid]s includ$ 9 su* provid] directory z foll[s3 7,i7 ,su* a r&om sample %all include a r&om sample ( ea* specialty ( provid]s ) a high inaccuracy rate ( provid] directory in=mation relative to o!r specialties ( provid]s1 z det]m9$ by ! ,secret>y4 7,,ii7 ,= purposes ( subclause 7,i71 "o type ( specialty may be provid]s specializ+ 9 m5tal heal? or sub/ance use disord] treatm5t4 7ii7 ,submit to ! ,secret>y a report conta9+ ! results ( ! analysis conduct$ "u clause 7i71 includ+ an accuracy score = su* provid] directory in=mation 7z det]m9$ us+ a plan v]ification me?od specifi$ by ! ,secret>y "u subp>agraph 7,b77i774 7,b7 ,det]m9ation ( accuracy score 7i7 ,9 g5]al ,! ,secret>y %all specify plan v]ification me?ods1 su* z us+ telephonic v]ification or o!r approa*es us+ data s\rces ma9ta9$ by an ,,ma organization or us+ publicly available data sets1 t ,,ma organizations may use = e/imat+ accuracy scores ( ! provid] directory in=mation ( specifi$ ,,ma plans (f]$ by su* organizations4 7ii7 ,accuracy score me?odology ,) respect to ea* su* me?od specifi$ by ! ,secret>y z describ$ 9 clause 7i71 ! ,secret>y %all specify a me?odology = ,,ma organizations to use 9 e/imat+ su* accuracy scores4 ,ea* su* me?odology %all take into acc\nt ! adm9i/rative burd5 on plans & provid]s & ! relative importance ( c]ta9 provid] directory in=mation on enrollee ability to access c>e4 7,c7 ,exception ,! ,secret>y may waive ! requirem5ts ( ?is p>agraph 9 ! case ( a specifi$ ,,ma plan ) l[ enrollm5t 7z def9$ by ! ,secret>y74 7,d7 ,transp>5cy ,beg9n+ ) plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbh1 ! ,secret>y %all po/ accuracy scores 7z report$ "u subp>agraph 7,a77ii771 9 a ma*9e readable file1 on ! int]net website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices4 4 7,b7 ,provision ( in=mation to b5efici>ies ,section #ahea7;d77#d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ba7;d77#d77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,f7 ,provid] ,directory ,beg9n+ ) plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbh1 ! accuracy score ( ! plan's provid] directory 7z report$ "u section #aheg7;e77#f77;,a77ii77 li/$ prom95tly on ! plan's provid] directory4 4 7,c7 ,fund+ ,9 addition to am\nts o!rwise available1 !re is appropriat$ to ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices ,program ,managem5t ,acc\nt1 out ( any money 9 ! ,treasury n o!rwise appropriat$1 #d1jjj1jjj = fiscal ye> #bjbe1 to rema9 available until exp5d$1 to c>ry out ! am5dm5ts made by ?is p>agraph4 7#c7 ,,gao /udy & report 7,a7 ,analysis ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 79 ?is p>agraph ref]r$ to z ! ,comptroll] ,g5]al7 %all conduct a /udy ( ! implem5tation ( ! am5dm5ts made by p>agraphs 7#a7 & 7#b74 ,to ! ext5t data are available & reliable1 su* /udy %all include an analysis (-- 7i7 ! use ( co/-%>+ protections requir$ "u section #aheb7;d77#g77;,a7 ( ! ,social ,security ,act1 z add$ by p>agraph 7#a72 7ii7 ! tr5ds 9 provid] directory in=mation accuracy scores "u section #aheg7;e77#f77;,a77ii7 ( ! ,social ,security ,act 7z add$ by p>agraph 7#b77;,a771 bo? ov]all & among provid]s specializ+ 9 m5tal heal? or sub/ance use disord] treatm5t2 7iii7 provid] response rates by plan v]ification me?ods2 7iv7 adm9i/rative co/s to provid]s & ,m$ic>e ,advantage organizations2 & 7v7 o!r items det]m9$ appropriate by ! ,comptroll] ,g5]al4 7,b7 ,report ,n lat] ?an ,janu>y #ae1 #bjcb1 ! ,comptroll] ,g5]al %all submit to ,congress a report conta9+ ! results ( ! /udy conduct$ "u subp>agraph 7,a71 toge!r ) recomm5dations = su* legislation & adm9i/rative action z ! ,comptroll] ,g5]al det]m9es appropriate4 7c7 ,guidance on ma9ta9+ accurate provid] directories 7#a7 ,/akehold] meet+ 7,a7 ,9 g5]al ,n lat] ?an #c mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is subsection z ! ,secret>y7 %all hold a public meet+ to receive input on approa*es = ma9ta9+ accurate provid] directories = ,m$ic>e ,advantage plans "u "p ,c ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ba et seq471 includ+ input on approa*es = r$uc+ adm9i/rative burd51 su* z data /&>dization1 & be/ practices to ma9ta9 accurate provid] directory in=mation4 7,b7 ,p>ticipants ,p>ticipants ( ! meet+ "u subp>agraph 7,a7 %all include repres5tatives f ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices & ! ,assi/ant ,secret>y = ,te*nology ,policy & ,(fice ( ! ,national ,coord9ator = ,heal? ,in=mation ,te*nology4 ,su* meet+ %all be op5 to ! public4 ,to ! ext5t practicable1 ! ,secret>y %all include heal? c>e provid]s1 companies t specialize 9 relevant te*nologies1 heal? insur]s1 & pati5t advocates4 7#b7 ,guidance to ,m$ic>e ,advantage organizations ,n lat] ?an #ab mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all issue guidance to ,m$ic>e ,advantage organizations (f]+ ,m$ic>e ,advantage plans "u "p ,c ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ba et seq47 on ma9ta9+ accurate provid] directories = su* plans1 tak+ into consid]ation input receiv$ dur+ ! /akehold] meet+ "u p>agraph 7#a74 ,su* guidance may include ! foll[+1 z det]m9$ appropriate by ! ,secret>y3 7,a7 ,be/ practices = ,m$ic>e ,advantage organizations on h[ to "w ) provid]s to ma9ta9 ! accuracy ( provid] directories & r$uce provid] & ,m$ic>e ,advantage organization burd5 ) respect to ma9ta9+ ! accuracy ( provid] directories4 7,b7 ,in=mation on data sets & data s\rces ) in=mation t c\ld be us$ by ,m$ic>e ,advantage organizations to ma9ta9 accurate provid] directories4 7,c7 ,approa*es = utiliz+ data s\rces ma9ta9$ by ,m$ic>e ,advantage organizations & publicly available data sets to ma9ta9 accurate provid] directories4 7,d7 ,in=mation to be includ$ 9 provid] directories t may be useful = ,m$ic>e b5efici>ies to assess plan networks :5 select+ a plan & access+ provid]s p>ticipat+ 9 plan networks dur+ ! plan ye>4 7#c7 ,guidance to "p ,b provid]s ,n lat] ?an #ab mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all issue guidance to provid]s ( s]vices & suppli]s :o furni% items or s]vices = :i* b5efits are available "u "p ,b ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;j et seq47 on :5 to update ! ,national ,plan & ,provid] ,enum]ation ,sy/em = in=mation *anges4 #bbd4 ,m$ic>e cov]age ( multi-canc] e>ly detection scre5+ te/s 7a7 ,cov]age ,section #ahfa ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7 is am5d$-- 7#a7 9 subsection 7s77#b7-- 7,a7 by /rik+ ! semicolon at ! end ( subp>agraph 7,,jj7 & ins]t+ 2 &2 & 7,b7 by add+ at ! end ! foll[+ new subp>agraph3 7,,kk7 multi-canc] e>ly detection scre5+ te/s 7z def9$ 9 subsection 7nnn772 2 & 7#b7 by add+ at ! end ! foll[+ new subsection3 7nnn7 ,multi-,canc] e>ly detection scre5+ te/s 7#a7 ,9 g5]al ,! t]m multi-canc] e>ly detection scre5+ te/ means a te/ furni%$ to an individual = ! concurr5t detection ( multiple canc] types across multiple organ sites on or aft] ,janu>y #a1 #bjbi1 t-- 7,a7 is cle>$ "u section #eaj7k71 classifi$ "u section #eac7;f77#b71 or approv$ "u section #eae ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 7,b7 is-- 7i7 a g5omic sequ5c+ blood or blood product te/ t includes ! analysis ( cell-free nucleic acids2 or 7ii7 a te/ bas$ on samples ( biological mat]ial t provide results comp>able to ^? obta9$ ) a te/ describ$ 9 clause 7i71 z det]m9$ by ! ,secret>y2 & 7,c7 ! ,secret>y det]m9es is-- 7i7 reasonable & necess>y = ! prev5tion or e>ly detection ( an illness or disability2 & 7ii7 appropriate = individuals entitl$ to b5efits "u "p ,a or enroll$ "u "p ,b4 7#b7 ,,ncd process ,9 mak+ det]m9ations "u p>agraph 7#a77;,c7 reg>d+ ! cov]age ( a new te/1 ! ,secret>y %all use ! process = mak+ national cov]age det]m9ations 7z def9$ 9 section #ahfi7;f77#a77;,b77 "u ?is title4 4 7b7 ,paym5t & /&>ds = multi-,canc] e>ly detection scre5+ te/s 7#a7 ,9 g5]al ,section #ahcd ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7aa7 ,paym5t & /&>ds = multi-,canc] e>ly detection scre5+ te/s 7#a7 ,paym5t am\nt ,! paym5t am\nt = a multi-canc] e>ly detection scre5+ te/ 7z def9$ 9 section #ahfa7nnn77 is-- 7,a7 ) respect to su* a te/ furni%$ be=e ,janu>y #a1 #bjca1 equal to ! paym5t am\nt 9 effect on ! date ( ! enactm5t ( ?is subsection = a multi-t>get /ool scre5+ ,,dna te/ cov]$ pursuant to section #ahfa7pp77#a77;,d72 & 7,b7 ) respect to su* a te/ furni%$ on or aft] ,janu>y #a1 #bjca1 equal to ! less] (-- 7i7 ! am\nt describ$ 9 subp>agraph 7,a72 or 7ii7 ! paym5t am\nt det]m9$ = su* te/ "u section #ahcd;,a4 7#b7 ,limitations 7,a7 ,9 g5]al ,no paym5t may be made "u ?is "p = a multi-canc] e>ly detection scre5+ te/ furni%$ dur+ a ye> to an individual if-- 7i7 su* individual-- 7,i7 is "u #ej ye>s ( age2 or 7,,ii7 z ( ,janu>y #a ( su* ye>1 has atta9$ ! age specifi$ 9 subp>agraph 7,b7 = su* ye>2 or 7ii7 su* a te/ 0 furni%$ to ! individual dur+ ! previ\s #aa mon?s4 7,b7 ,age specifi$ ,= purposes ( subp>agraph 7,a77i77,,ii71 ! age specifi$ 9 ?is subp>agraph is-- 7i7 = #bjbi1 #fe ye>s ( age2 & 7ii7 = a succe$+ ye>1 ! age specifi$ 9 ?is subp>agraph = ! prec$+ ye>1 increas$ by #a ye>4 7,c7 ,/&>ds foll[+ ,,usp/f rat+ ( ,a or ,b ,9 ! case ( a multi-canc] e>ly detection scre5+ te/ t is recomm5d$ ) a grade ( ,a or ,b by ! ,unit$ ,/ates ,prev5tive ,s]vices ,task ,=ce1 beg9n+ on ! date on :i* cov]age = su* te/ is provid$ pursuant to section #ahfa7;ddd77#a71 ! prec$+ provisions ( ?is p>agraph %all n apply4 4 7#b7 ,con=m+ am5dm5ts 7,a7 ,section #ahcc ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7 is am5d$-- 7i7 9 subsection 7a7-- 7,i7 9 p>agraph 7#a77;,d77i77,i71 by /rik+ section #ahcd7;d77#a7 & ins]t+ subsection 7d77#a7 or 7aa7 ( section #ahcd2 & 7,,ii7 9 p>agraph 7#b77;,d77i77,i71 by /rik+ section #ahcd7;d77#a7 & ins]t+ subsection 7d77#a7 or 7aa7 ( section #ahcd2 & 7ii7 9 subsection 7h77#a77;,a71 by /rik+ section #ahcd7;d77#a7 & ins]t+ subsections 7d77#a7 & 7aa7 ( section #ahcd4 7,b7 ,section #ahfb7;a77#a77;,a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciey7a77#a77;,a77 is am5d$-- 7i7 by /rik+ or additional prev5tive s]vices & ins]t+ 1 additional prev5tive s]vices2 & 7ii7 by ins]t+ 1 or multi-canc] e>ly detection scre5+ te/s 7z def9$ 9 section #ahfa7nnn77 aft] 7z describ$ 9 section #ahfa7;ddd77#a774 7c7 ,rule ( con/ruction relat+ to o!r canc] scre5+ te/s ,no?+ 9 ?is section1 includ+ ! am5dm5ts made by ?is section1 %all be con/ru$-- 7#a7 9 ! case ( an individual :o und]goes a multi-canc] e>ly detection scre5+ te/1 to affect cov]age "u "p ,b ( title ,,xviii ( ! ,social ,security ,act = o!r canc] scre5+ te/s cov]$ "u su* title1 su* z scre5+ te/s = brea/1 c]vical1 colorectal1 lung1 or pro/ate canc]2 or 7#b7 9 ! case ( an individual :o und]goes ano!r canc] scre5+ te/1 to affect cov]age "u su* "p = a multi-canc] e>ly detection scre5+ te/ or ! use ( su* a te/ z a diagno/ic or confirmatory te/ = a result ( ! o!r canc] scre5+ te/4 #bbe4 ,m$ic>e cov]age ( ext]nal infusion pumps & non-self-adm9i/rable home infusion drugs 7a7 ,9 g5]al ,section #ahfa7n7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7n77 is am5d$ by add+ at ! end ! foll[+ new s5t5ce3 ,beg9n+ ) ! fir/ cal5d> qu>t] beg9n+ on or aft] ! date t is #a ye> aft] ! date ( ! enactm5t ( ?is s5t5ce1 an ext]nal infusion pump & associat$ home infusion drug 7z def9$ 9 subsection 7iii77#c77;,c77 or o!r associat$ supplies t d n meet ! appropriate = use 9 ! home requirem5t appli$ to ! def9ition ( durable m$ical equipm5t "u section #dad4bjb ( title #db1 ,code ( ,f$]al ,regulations 7or any successor to su* regulation7 %all be treat$ z meet+ su* requirem5t if ea* ( ! foll[+ crit]ia is satisfi$3 7#a7 ,! prescrib+ in=mation approv$ by ! ,food & ,drug ,adm9i/ration = ! home infusion drug associat$ ) ! pump in/ructs t ! drug %\ld be adm9i/]$ by or "u ! sup]vision ( a heal? c>e pr(essional4 7#b7 ,a qualifi$ home infusion !rapy suppli] 7z def9$ 9 subsection 7iii77#c77;,d77 adm9i/]s or sup]vises ! adm9i/ration ( ! drug or biological 9 a safe & effective mann] 9 ! pati5t's home 7z def9$ 9 subsection 7iii77#c77;,b774 7#c7 ,! prescrib+ in=mation describ$ 9 p>agraph 7#a7 in/ructs t ! drug %\ld be infus$ at lea/ #ab times p] ye>-- 7,a7 intrav5\sly or subcutane\sly2 or 7,b7 at infusion rates t ! ,secret>y det]m9es w\ld require ! use ( an ext]nal infusion pump4 4 7b7 ,co/ %>+ notification ,! ,secret>y ( ,heal? & ,human ,s]vices %all ensure t pati5ts are notifi$ ( ! co/ %>+ = elect+ home infusion !rapy comp>$ to o!r applicable sett+s ( c>e = ! furni%+ ( infusion drugs "u ! ,m$ic>e program4 #bbf4 ,assur+ ph>macy access & *oice = ,m$ic>e b5efici>ies 7a7 ,9 g5]al ,section #ahfj;,d-#d7;b77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;b77#a77 is am5d$ by /rik+ subp>agraph 7,a7 & ins]t+ ! foll[+3 7,a7 ,9 g5]al 7i7 ,p>ticipation ( any will+ ph>macy ,a ,,pdp sponsor (f]+ a prescription drug plan %all p]mit any ph>macy t meets ! /&>d contract t]ms & conditions "u su* plan to p>ticipate z a network ph>macy ( su* plan4 7ii7 ,contract t]ms & conditions 7,i7 ,9 g5]al ,not)/&+ any o!r provision ( law1 = plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbh1 9 accordance ) clause 7i71 contract t]ms & conditions (f]$ by su* ,,pdp sponsor %all be reasonable & relevant accord+ to /&>ds e/abli%$ by ! ,secret>y "u subclause 7,,ii74 7,,ii7 ,/&>ds ,n lat] ?an ! fir/ ,monday 9 ,april ( #bjbg1 ! ,secret>y %all e/abli% /&>ds = reasonable & relevant contract t]ms & conditions = purposes ( ?is clause4 7,,iii7 ,reque/ = in=mation ,n lat] ?an ,april #a1 #bjbf1 = purposes ( e/abli%+ ! /&>ds "u subclause 7,,ii71 ! ,secret>y %all issue a reque/ = in=mation to seek input on tr5ds 9 prescription drug plan & network ph>macy contract t]ms & conditions1 curr5t prescription drug plan & network ph>macy contract+ practices1 :e!r ph>macy reimbursem5t & disp5s+ fees paid by ,,pdp sponsors to network ph>macies suffici5tly cov] ! +r$i5t & op]ational co/s ( su* ph>macies1 ! use & application ( ph>macy quality measures by ,,pdp sponsors = network ph>macies1 ,,pdp sponsor re/rictions or limitations on ! disp5s+ ( cov]$ "p ,d drugs by network ph>macies 7or any subsets ( su* ph>macies71 ,,pdp sponsor audit+ practices = network ph>macies1 areas 9 curr5t regulations or program guidance relat$ to contract+ betwe5 prescription drug plans & network ph>macies requir+ cl>ification or additional specificity1 factors = consid]ation 9 det]m9+ ! reasonabl5ess & relevance ( contract t]ms & conditions betwe5 prescription drug plans & network ph>macies1 & o!r issues z det]m9$ appropriate by ! ,secret>y4 4 7b7 ,ess5tial retail ph>macies ,section #ahfj;,d-#db ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aeb7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7e7 ,ess5tial retail ph>macies 7#a7 ,9 g5]al ,) respect to plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbh1 ! ,secret>y %all publi% reports1 at lea/ once e #b ye>s until #bjcd1 & p]iodically !reaft]1 t provide in=mation1 to ! ext5t feasible1 on-- 7,a7 tr5ds 9 +r$i5t co/ reimbursem5t1 disp5s+ fees1 inc5tive paym5ts & o!r fees paid by ,,pdp sponsors (f]+ prescription drug plans & ,,ma organizations (f]+ ,,ma-,,pd plans "u ?is "p to ess5tial retail ph>macies 7z def9$ 9 p>agraph 7#b77 ) respect to ! disp5s+ ( cov]$ "p ,d drugs1 includ+ a comp>ison ( su* tr5ds betwe5 ess5tial retail ph>macies & ph>macies t are n ess5tial retail ph>macies2 7,b7 tr5ds 9 am\nts paid to ,,pdp sponsors (f]+ prescription drug plans & ,,ma organizations (f]+ ,,ma-,,pd plans "u ?is "p by ess5tial retail ph>macies ) respect to ! disp5s+ ( cov]$ "p ,d drugs1 includ+ a comp>ison ( su* tr5ds betwe5 ess5tial retail ph>macies & ph>macies t are n ess5tial retail ph>macies2 7,c7 tr5ds 9 ess5tial retail ph>macy p>ticipation 9 ph>macy networks & pref]r$ ph>macy networks = prescription drug plans (f]$ by ,,pdp sponsors & ,,ma-,,pd plans (f]$ by ,,ma organizations "u ?is "p1 includ+ a comp>ison ( su* tr5ds betwe5 ess5tial retail ph>macies & ph>macies t are n ess5tial retail ph>macies2 7,d7 tr5ds 9 ! numb] ( ess5tial retail ph>macies1 includ+ v>iation 9 su* tr5ds by geographic region or o!r factors2 7,e7 a comp>ison ( co/-%>+ = cov]$ "p ,d drugs disp5s$ by ess5tial retail ph>macies t are network ph>macies = prescription drug plans (f]$ by ,,pdp sponsors & ,,ma-,,pd plans (f]$ by ,,ma organizations "u ?is "p & co/-%>+ = cov]$ "p ,d drugs disp5s$ by o!r network ph>macies = su* plans locat$ 9 simil> geographic areas t are n ess5tial retail ph>macies2 7,f7 a comp>ison ( ! volume ( cov]$ "p ,d drugs disp5s$ by ess5tial retail ph>macies t are network ph>macies = prescription drug plans (f]$ by ,,pdp sponsors & ,,ma-,,pd plans (f]$ by ,,ma organizations "u ?is "p & su* volume ( disp5s+ by network ph>macies = su* plans locat$ 9 simil> geographic areas t are n ess5tial retail ph>macies1 includ+ in=mation on any patt]ns or tr5ds 9 su* comp>ison specific to c]ta9 types ( cov]$ "p ,d drugs1 su* z g5]ic drugs or drugs specifi$ z specialty drugs by a ,,pdp sponsor "u a prescription drug plan or an ,,ma organization "u an ,,ma-,,pd plan2 & 7,g7 a comp>ison ( ! in=mation describ$ 9 subp>agraphs 7,a7 ?r\gh 7,f7 betwe5 ess5tial retail ph>macies t are network ph>macies = prescription drug plans (f]$ by ,,pdp sponsors "u ?is "p & ess5tial retail ph>macies t are network ph>macies = ,,ma-,,pd plans (f]$ by ,,ma organizations "u ?is "p4 7#b7 ,def9ition ( ess5tial retail ph>macy ,9 ?is subsection1 ! t]m ess5tial retail ph>macy means1 ) respect to a plan ye>1 a retail ph>macy t-- 7,a7 is n a ph>macy t is an affiliate z def9$ 9 p>agraph 7#d72 & 7,b7 is locat$ 9-- 7i7 a m$ically und]s]v$ area 7z designat$ pursuant to section #ccj7;b77#c77;,a7 ( ! ,public ,heal? ,s]vice ,act72 7ii7 a rural area 9 :i* !re is no o!r retail ph>macy )9 #aj miles1 z det]m9$ by ! ,secret>y2 7iii7 a suburban area 9 :i* !re is no o!r retail ph>macy )9 #b miles1 z det]m9$ by ! ,secret>y2 or 7iv7 an urban area 9 :i* !re is no o!r retail ph>macy )9 #a mile1 z det]m9$ by ! ,secret>y4 7#c7 ,li/ ( ess5tial retail ph>macies 7,a7 ,publication ( li/ ( ess5tial retail ph>macies ,= ea* plan ye> 7beg9n+ ) plan ye> #bjbh71 ! ,secret>y %all publi%1 on a publicly available int]net website ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 a li/ ( ph>macies t meet ! crit]ia describ$ 9 subp>agraphs 7,a7 & 7,b7 ( p>agraph 7#b7 to be consid]$ an ess5tial retail ph>macy4 7,b7 ,requir$ submissions f pdp sponsors ,= ea* plan ye> 7beg9n+ ) plan ye> #bjbh71 ea* ,,pdp sponsor (f]+ a prescription drug plan & ea* ,,ma organization (f]+ an ,,ma-,,pd plan %all submit to ! ,secret>y1 = ! purposes ( det]m9+ retail ph>macies t meet ! crit]ion specifi$ 9 subp>agraph 7,a7 ( p>agraph 7#b71 a li/ ( retail ph>macies t are affiliates ( su* sponsor or organization1 or are affiliates ( a ph>macy b5efit manag] act+ on behalf ( su* sponsor or organization1 at a "t1 & 9 a =m & mann]1 specifi$ by ! ,secret>y4 7,c7 ,report+ by pdp sponsors & ma organizations ,= ea* plan ye> beg9n+ ) plan ye> #bjbg1 ea* ,,pdp sponsor (f]+ a prescription drug plan & ea* ,,ma organization (f]+ an ,,ma-,,pd plan "u ?is "p %all submit to ! ,secret>y in=mation on inc5tive paym5ts & o!r fees paid by su* sponsor or organization to ph>macies1 ins(> z any su* paym5ts or fees are n o!rwise report$1 at a "t1 & 9 a =m & mann]1 specifi$ by ! ,secret>y4 7,d7 ,implem5tation ,not)/&+ any o!r provision ( law1 ! ,secret>y may implem5t ?is p>agraph by program in/ruction or o!rwise4 7,e7 ,nonapplication ( pap]work r$uction act ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to ! implem5tation ( ?is p>agraph4 7#d7 ,def9ition ( affiliate2 ph>macy b5efit manag] ,9 ?is subsection1 ! t]ms affiliate & ph>macy b5efit manag] h ! mean+ giv5 ^? t]ms 9 section #ahfj;,d-#ab7;h77#g74 4 7c7 ,en=cem5t 7#a7 ,9 g5]al ,section #ahfj;,d-#d7;b77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;b77#a77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,f7 ,en=cem5t ( /&>ds = reasonable & relevant contract t]ms & conditions 7i7 ,allegation submission process 7,i7 ,9 g5]al ,n lat] ?an ,janu>y #a1 #bjbh1 ! ,secret>y %all e/abli% a process ?r\gh :i* a ph>macy may submit to ! ,secret>y an allegation ( a violation by a ,,pdp sponsor (f]+ a prescription drug plan ( ! /&>ds = reasonable & relevant contract t]ms & conditions "u subp>agraph 7,a77ii71 or ( subclause 7,,viii7 ( ?is clause4 7,,ii7 ,frequ5cy ( submission 7aa7 ,9 g5]al ,except z provid$ 9 item 7bb71 ! allegation submission process "u ?is clause %all all[ ph>macies to submit any allegations ( violations describ$ 9 subclause 7,i7 n m frequ5tly ?an once p] plan ye> p] contract betwe5 a ph>macy & a ,,pdp sponsor4 7bb7 ,allegations relat+ to contract modifications ,9 ! case :]e a contract betwe5 a ph>macy & a ,,pdp sponsor is modifi$ foll[+ ! submission ( allegations by a ph>macy ) respect to su* contract & plan ye>1 ! allegation submission process "u ?is clause %all all[ su* ph>macy to submit an additional allegation relat$ to ^? modifications ) respect to su* contract & plan ye>4 7,,iii7 ,access to relevant docum5ts & mat]ials ,a ,,pdp sponsor subject to an allegation "u ?is clause-- 7aa7 %all provide docum5ts or mat]ials1 z specifi$ by ! ,secret>y1 includ+ contract (f]s made by su* sponsor to su* ph>macy or correspond5ce relat$ to su* (f]s1 to ! ,secret>y at a "t1 & 9 a =m & mann]1 specifi$ by ! ,secret>y2 & 7bb7 %all n prohibit or o!rwise limit ! ability ( a ph>macy to submit su* docum5ts or mat]ials to ! ,secret>y = ! purpose ( submitt+ an allegation or provid+ evid5ce = su* an allegation "u ?is clause4 7,,iv7 ,/&>diz$ template ,! ,secret>y %all e/abli% a /&>diz$ template = ph>macies to use = ! submission ( allegations describ$ 9 subclause 7,i74 ,su* template %all require t ! submission include a c]tification by ! ph>macy t ! in=mation includ$ is accurate1 complete1 & true to ! be/ ( ! k1 in=mation1 & belief ( su* ph>macy4 7,v7 ,prev5t+ frivol\s allegations ,9 ! case :]e ! ,secret>y det]m9es t a ph>macy has submitt$ frivol\s allegations "u ?is clause on a r\t9e basis1 ! ,secret>y may tempor>ily prohibit su* ph>macy f us+ ! allegation submission process "u ?is clause1 z det]m9$ appropriate by ! ,secret>y4 7,,vi7 ,exemption f fre$om ( in=mation act ,allegations submitt$ "u ?is clause %all be exempt f disclosure "u section #eeb ( title #e1 ,unit$ ,/ates ,code4 7,,vii7 ,rule ( con/ruction ,no?+ 9 ?is clause %all be con/ru$ z limit+ ! ability ( a ph>macy to pursue o!r legal actions or rem$ies1 consi/5t ) applicable ,f$]al or ,/ate law1 ) respect to a pot5tial violation ( a requirem5t describ$ 9 ?is subp>agraph4 7,,viii7 ,anti-retaliation & anti-co]cion ,consi/5t ) applicable ,f$]al or ,/ate law1 a ,,pdp sponsor %all n-- 7aa7 retaliate aga9/ a ph>macy = submitt+ any allegations "u ?is clause2 or 7bb7 co]ce1 intimidate1 ?reat51 or int]f]e ) ! ability ( a ph>macy to submit any su* allegations4 7ii7 ,inve/igation ,! ,secret>y %all inve/igate1 z det]m9$ appropriate by ! ,secret>y1 allegations submitt$ pursuant to clause 7i74 7iii7 ,en=cem5t 7,i7 ,9 g5]al ,9 ! case :]e ! ,secret>y det]m9es t a ,,pdp sponsor (f]+ a prescription drug plan has violat$ ! /&>ds = reasonable & relevant contract t]ms & conditions "u subp>agraph 7,a77ii71 ! ,secret>y may use au?orities "u sections #aheg7;g7 & #ahfj;,d-#ab7;b77#c77;,e7 to impose civil monet>y p5alties or o!r int]m$iate sanctions4 7,,ii7 ,application ( civil monet>y p5alties ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil monet>y p5alty "u ?is clause 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 4 7#b7 ,con=m+ am5dm5t ,section #aheg7;g77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;g77#a77 is am5d$-- 7,a7 9 subp>agraph 7,j71 by /rik+ or aft] ! semicolon2 7,b7 by r$esignat+ subp>agraph 7,k7 z subp>agraph 7,l72 7,c7 by ins]t+ aft] subp>agraph 7,j71 ! foll[+ new subp>agraph3 7,k7 fails to comply ) ! /&>ds = reasonable & relevant contract t]ms & conditions "u subp>agraph 7,a77ii7 ( section #ahfj;,d-#d7;b77#a72 or 2 7,d7 9 subp>agraph 7,l71 z r$esignat$ by subp>agraph 7,b71 by /rik+ ?r\gh 7,j7 & ins]t+ ?r\gh 7,k72 & 7,e7 9 ! flu% matt] foll[+ subp>agraph 7,l71 z s r$esignat$1 by /rik+ subp>agraphs 7,a7 ?r\gh 7,k7 & ins]t+ subp>agraphs 7,a7 ?r\gh 7,l74 7d7 ,acc\ntability ( ph>macy b5efit manag]s = violations ( reasonable & relevant contract t]ms & conditions 7#a7 ,9 g5]al ,section #ahfj;,d-#ab7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#i7 ,acc\ntability ( ph>macy b5efit manag]s = violations ( reasonable & relevant contract t]ms & conditions ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbh1 ea* contract ent]$ into ) a ,,pdp sponsor "u ?is "p ) respect to a prescription drug plan (f]$ by su* sponsor %all provide t any ph>macy b5efit manag] act+ on behalf ( su* sponsor has a writt5 agreem5t ) ! ,,pdp sponsor "u :i* ! ph>macy b5efit manag] agrees to reimburse ! ,,pdp sponsor = any am\nts paid by su* sponsor "u section #ahfj;,d-#d7;b77#a77;,f77iii77,i7 to ! ,secret>y z a result ( a violation describ$ 9 su* section if su* violation is relat$ to a responsibility delegat$ to ! ph>macy b5efit manag] by su* ,,pdp sponsor4 4 7#b7 ,,ma-,,pd plans ,section #aheg7;f77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;f77#c77 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,f7 ,acc\ntability ( ph>macy b5efit manag]s = violations ( reasonable & relevant contract t]ms ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbh1 section #ahfj;,d-#ab7;b77#i74 4 7e7 ,bi5nial report on en=cem5t & ov]sight ( ph>macy access requirem5ts ,section #ahfj;,d-#db ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aeb71 z am5d$ by subsection 7b71 is am5d$ by add+ at ! end ! foll[+ new subsection3 7f7 ,bi5nial report on en=cem5t & ov]sight ( ph>macy access requirem5ts 7#a7 ,9 g5]al ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is subsection1 & at lea/ once e #b ye>s !reaft]1 ! ,secret>y %all publi% a report on en=cem5t & ov]sight actions & activities und]tak5 by ! ,secret>y ) respect to ! requirem5ts "u section #ahfj;,d-#d7;b77#a74 7#b7 ,limitation ,a report "u p>agraph 7#a7 %all n disclose-- 7,a7 id5tifiable in=mation ab\t individuals or entities unless su* in=mation is o!rwise publicly available2 or 7,b7 trade secrets ) respect to any entities4 4 7f7 ,fund+ ,9 addition to am\nts o!rwise available1 !re is appropriat$ to ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices ,program ,managem5t ,acc\nt1 out ( any money 9 ! ,treasury n o!rwise appropriat$1 #ahh1jjj1jjj = fiscal ye> #bjbe1 to rema9 available until exp5d$1 to c>ry out ?is section4 #bbg4 ,mod]niz+ & ,ensur+ ,,pbm ,acc\ntability 7a7 ,9 g5]al 7#a7 ,prescription drug plans ,section #ahfj;,d-#ab ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7h7 ,requirem5ts relat+ to ph>macy b5efit manag]s ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbh3 7#a7 ,agreem5ts ) ph>macy b5efit manag]s ,ea* contract ent]$ into ) a ,,pdp sponsor "u ?is "p ) respect to a prescription drug plan (f]$ by su* sponsor %all provide t any ph>macy b5efit manag] act+ on behalf ( su* sponsor has a writt5 agreem5t ) ! ,,pdp sponsor "u :i* ! ph>macy b5efit manag]1 & any affiliates ( su* ph>macy b5efit manag]1 z applicable1 agree to meet ! foll[+ requirem5ts3 7,a7 ,no income o!r ?an bona fide s]vice fees 7i7 ,9 g5]al ,! ph>macy b5efit manag] & any affiliate ( su* ph>macy b5efit manag] %all n d]ive any remun]ation ) respect to any s]vices provid$ on behalf ( any entity or individual1 9 connection ) ! utilization ( cov]$ "p ,d drugs1 f any su* entity or individual o!r ?an bona fide s]vice fees1 subject to clauses 7ii7 & 7iii74 7ii7 ,inc5tive paym5ts ,= ! purposes ( ?is subsection1 an inc5tive paym5t 7z det]m9$ by ! ,secret>y7 paid by a ,,pdp sponsor to a ph>macy b5efit manag] t is p]=m+ s]vices on behalf ( su* sponsor %all be deem$ a bona fide s]vice fee 7ev5 if su* paym5t does n o!rwise meet ! def9ition ( su* t]m "u p>agraph 7#g77;,b77 if su* paym5t is a flat doll> am\nt1 is consi/5t ) fair m>ket value 7z specifi$ by ! ,secret>y71 is relat$ to s]vices actually p]=m$ by ! ph>macy b5efit manag] or affiliate ( su* ph>macy b5efit manag]1 on behalf ( ! ,,pdp sponsor mak+ su* paym5t1 9 connection ) ! utilization ( cov]$ "p ,d drugs1 & meets additional requirem5ts1 if any1 z det]m9$ appropriate by ! ,secret>y4 7iii7 ,cl>ification on rebates & disc\nts us$ to l[] co/s = cov]$ "p d drugs ,rebates1 disc\nts1 & o!r price concessions receiv$ by a ph>macy b5efit manag] or an affiliate ( a ph>macy b5efit manag] f manufactur]s1 ev5 if su* price concessions are calculat$ z a p]c5tage ( a drug's price1 %all n be consid]$ a violation ( ! requirem5ts ( clause 7i7 if !y are fully pass$ ?r\gh to a ,,pdp sponsor & are compliant ) all regulatory & subregulatory requirem5ts relat$ to direct & indirect remun]ation = manufactur] rebates "u ?is "p1 includ+ 9 cases :]e a ,,pdp sponsor is act+ z a ph>macy b5efit manag] on behalf ( a prescription drug plan (f]$ by su* ,,pdp sponsor4 7iv7 ,evaluation ( remun]ation arrangem5ts ,compon5ts ( subsets ( remun]ation arrangem5ts 7su* z fees or o!r =ms ( comp5sation paid to or reta9$ by ! ph>macy b5efit manag] or affiliate ( su* ph>macy b5efit manag]71 z det]m9$ appropriate by ! ,secret>y1 betwe5 ph>macy b5efit manag]s or affiliates ( su* ph>macy b5efit manag]s1 z applicable1 & o!r entities involv$ 9 ! disp5s+ or utilization ( cov]$ "p ,d drugs 7includ+ ,,pdp sponsors1 manufactur]s1 ph>macies1 & o!r entities z det]m9$ appropriate by ! ,secret>y7 %all be subject to review by ! ,secret>y1 9 consultation ) ! ,(fice ( ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 z det]m9$ appropriate by ! ,secret>y4 ,! ,secret>y1 9 consultation ) ! ,(fice ( ! ,inspector ,g5]al1 %all review :e!r remun]ation "u su* arrangem5ts is consi/5t ) fair m>ket value 7z specifi$ by ! ,secret>y7 ?r\gh reviews & assessm5ts ( su* remun]ation1 z det]m9$ appropriate4 7v7 ,disgorgem5t ,! ph>macy b5efit manag] %all disgorge any remun]ation paid to su* ph>macy b5efit manag] or an affiliate ( su* ph>macy b5efit manag] 9 violation ( ?is subp>agraph to ! ,,pdp sponsor4 7vi7 ,additional requirem5ts ,! ph>macy b5efit manag] %all-- 7,i7 ent] into a writt5 agreem5t ) any affiliate ( su* ph>macy b5efit manag]1 "u :i* ! affiliate %all id5tify & disgorge any remun]ation describ$ 9 clause 7v7 to ! ph>macy b5efit manag]2 & 7,,ii7 atte/1 subject to any requirem5ts det]m9$ appropriate by ! ,secret>y1 t ! ph>macy b5efit manag] has ent]$ into a writt5 agreem5t describ$ 9 subclause 7,i7 ) any relevant affiliate ( ! ph>macy b5efit manag]4 7,b7 ,transp>5cy reg>d+ gu>antees & co/ p]=mance evaluations ,! ph>macy b5efit manag] %all-- 7i7 def9e1 int]pret1 & apply1 9 a fully transp>5t & consi/5t mann] = purposes ( calculat+ or o!rwise evaluat+ ph>macy b5efit manag] p]=mance aga9/ pric+ gu>antees or simil> co/ p]=mance measurem5ts relat$ to rebates1 disc\nts1 price concessions1 or net co/s1 t]ms su* z-- 7,i7 g5]ic drug1 9 a mann] consi/5t ) ! def9ition ( ! t]m "u section #dbc4d ( title #db1 ,code ( ,f$]al ,regulations1 or a successor regulation2 7,,ii7 br& "n drug1 9 a mann] consi/5t ) ! def9ition ( ! t]m "u section #dbc4d ( title #db1 ,code ( ,f$]al ,regulations1 or a successor regulation2 7,,iii7 specialty drug2 7,,iv7 rebate2 & 7,v7 disc\nt2 7ii7 id5tify any drugs1 claims1 or price concessions exclud$ f any pric+ gu>antee or o!r co/ p]=mance measure 9 a cle> & consi/5t mann]2 & 7iii7 :]e a pric+ gu>antee or o!r co/ p]=mance measure is bas$ on a pric+ b5*m>k o!r ?an ! :olesale acquisition co/ 7z def9$ 9 section #ahdg;,a7c77#f77;,b77 ( a drug1 calculate & provide a :olesale acquisition co/-bas$ equival5t to ! pric+ gu>antee or o!r co/ p]=mance measure4 7,c7 ,provision ( in=mation 7i7 ,9 g5]al ,n lat] ?an ,july #a ( ea* ye>1 beg9n+ 9 #bjbh1 ! ph>macy b5efit manag] %all submit to ! ,,pdp sponsor1 & to ! ,secret>y1 a report1 9 accordance ) ?is subp>agraph1 & %all make su* report available to su* sponsor at no co/ to su* sponsor 9 a =mat specifi$ by ! ,secret>y "u p>agraph 7#e74 ,ea* su* report %all include1 ) respect to su* ,,pdp sponsor & ea* plan (f]$ by su* sponsor1 ! foll[+ in=mation ) respect to ! previ\s plan ye>3 7,i7 ,a li/ ( all drugs cov]$ by ! plan t 7 disp5s$ includ+1 ) respect to ea* su* drug-- 7aa7 ! br& "n1 g5]ic or non-propriet>y "n1 & ,national ,drug ,code2 7bb7 ! numb] ( plan enrollees = :om ! drug 0 disp5s$1 ! total numb] ( prescription claims = ! drug 7includ+ orig9al prescriptions & refills1 c\nt$ z sep>ate claims71 & ! total numb] ( dosage units ( ! drug disp5s$2 7cc7 ! numb] ( prescription claims describ$ 9 item 7bb7 by ea* type ( disp5s+ *annel ?r\gh :i* ! drug 0 disp5s$1 includ+ retail1 mail ord]1 specialty ph>macy1 long t]m c>e ph>macy1 home infusion ph>macy1 or o!r types ( ph>macies or provid]s2 7dd7 ! av]age :olesale acquisition co/1 li/$ z co/ p] day's supply1 co/ p] dosage unit1 & co/ p] typical c\rse ( treatm5t 7z applicable72 7ee7 ! av]age :olesale price = ! drug1 li/$ z price p] day's supply1 price p] dosage unit1 & price p] typical c\rse ( treatm5t 7z applicable72 7ff7 ! total out-(-pocket sp5d+ by plan enrollees on su* drug aft] application ( any b5efits "u ! plan1 includ+ plan enrollee sp5d+ ?r\gh copaym5ts1 co9surance1 & d$uctibles2 7gg7 total rebates paid by ! manufactur] on ! drug z report$ "u ! ,detail$ ,,dir ,report 7or any successor report7 submitt$ by su* sponsor to ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices2 7hh7 all o!r direct or indirect remun]ation on ! drug z report$ "u ! ,detail$ ,,dir ,report 7or any successor report7 submitt$ by su* sponsor to ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices2 7ii7 ! av]age ph>macy reimbursem5t am\nt paid by ! plan = ! drug 9 ! aggregate & disaggregat$ by disp5s+ *annel id5tifi$ 9 item 7cc72 7jj7 ! av]age ,national ,av]age ,drug ,acquisition ,co/ 7,,nadac72 & 7kk7 total manufactur]-d]iv$ rev5ue1 inclusive ( bona fide s]vice fees1 attributable to ! drug & reta9$ by ! ph>macy b5efit manag] & any affiliate ( su* ph>macy b5efit manag]4 7,,ii7 ,9 ! case ( a ph>macy b5efit manag] t has an affiliate t is a retail1 mail ord]1 or specialty ph>macy1 ) respect to drugs cov]$ by su* plan t 7 disp5s$1 ! foll[+ in=mation3 7aa7 ,! p]c5tage ( total prescriptions t 7 disp5s$ by ph>macies t are an affiliate ( ! ph>macy b5efit manag] = ea* drug4 7bb7 ,! int]qu>tile range ( ! total comb9$ co/s paid by ! plan & plan enrollees1 p] dosage unit1 p] c\rse ( treatm5t1 p] #cj-;day supply1 & p] #ij-;day supply = ea* drug disp5s$ by ph>macies t are n an affiliate ( ! ph>macy b5efit manag] & t are includ$ 9 ! ph>macy network ( su* plan4 7cc7 ,! int]qu>tile range ( ! total comb9$ co/s paid by ! plan & plan enrollees1 p] dosage unit1 p] c\rse ( treatm5t1 p] #cj-;day supply1 & p] #ij-;day supply = ea* drug disp5s$ by ph>macies t are an affiliate ( ! ph>macy b5efit manag] & t are includ$ 9 ! ph>macy network ( su* plan4 7dd7 ,! l[e/ total comb9$ co/ paid by ! plan & plan enrollees1 p] dosage unit1 p] c\rse ( treatm5t1 p] #cj-;day supply1 & p] #ij-;day supply1 = ea* drug t is available f any ph>macy includ$ 9 ! ph>macy network ( su* plan4 7ee7 ,! diff]5ce betwe5 ! av]age acquisition co/ ( ! affiliate1 su* z a ph>macy or o!r entity t acquires prescription drugs1 t initially acquires ! drug & ! am\nt report$ "u subclause 7,i77jj7 = ea* drug4 7ff7 ,a li/ inclusive ( ! br& "n1 g5]ic or non-propriet>y "n1 & ,national ,drug ,code ( cov]$ "p ,d drugs subject to an agreem5t ) a cov]$ entity "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act = :i* ! ph>macy b5efit manag] or an affiliate ( ! ph>macy b5efit manag] _h a contract or o!r arrangem5t ) su* a cov]$ entity 9 ! s]vice area ( su* plan4 7,,iii7 ,:]e a drug approv$ "u section #eje7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7ref]r$ to 9 ?is subclause z ! li/$ drug7 is cov]$ by ! plan1 ! foll[+ in=mation3 7aa7 ,a li/ ( curr5tly m>ket$ g5]ic drugs approv$ "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act pursuant to an application t ref]5ces su* li/$ drug t are n cov]$ by ! plan1 are cov]$ on ! same =mul>y ti] or a =mul>y ti] typically associat$ ) high] co/-%>+ ?an ! li/$ drug1 or are subject to utilization managem5t t ! li/$ drug is n subject to4 7bb7 ,! e/imat$ av]age b5efici>y co/-%>+ "u ! plan = a #cj-;day supply ( ! li/$ drug4 7cc7 ,:]e a g5]ic drug li/$ "u item 7aa7 is on a =mul>y ti] typically associat$ ) high] co/-%>+ ?an ! li/$ drug1 ! e/imat$ av]age co/-%>+ t a b5efici>y w\ld h paid = a #cj-;day supply ( ea* ( ! g5]ic drugs describ$ 9 item 7aa71 _h ! plan provid$ cov]age = su* drugs on ! same =mul>y ti] z ! li/$ drug4 7dd7 ,a writt5 ju/ification = provid+ m favorable cov]age ( ! li/$ drug ?an ! g5]ic drugs describ$ 9 item 7aa74 7ee7 ,! numb] ( curr5tly m>ket$ g5]ic drugs approv$ "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act pursuant to an application t ref]5ces su* li/$ drug4 7,,iv7 ,:]e a ref]5ce product 7z def9$ 9 section #cea7;i7 ( ! ,public ,heal? ,s]vice ,act7 is cov]$ by ! plan1 ! foll[+ in=mation3 7aa7 ,a li/ ( curr5tly m>ket$ biosimil> biological products lic5s$ "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act pursuant to an application t ref]s to su* ref]5ce product t are n cov]$ by ! plan1 are cov]$ on ! same =mul>y ti] or a =mul>y ti] typically associat$ ) high] co/-%>+ ?an ! ref]5ce product1 or are subject to utilization managem5t t ! ref]5ce product is n subject to4 7bb7 ,! e/imat$ av]age b5efici>y co/-%>+ "u ! plan = a #cj-;day supply ( ! ref]5ce product4 7cc7 ,:]e a biosimil> biological product li/$ "u item 7aa7 is on a =mul>y ti] typically associat$ ) high] co/-%>+ ?an ! ref]5ce product1 ! e/imat$ av]age co/-%>+ t a b5efici>y w\ld h paid = a #cj-;day supply ( ea* ( ! biosimil> biological products describ$ 9 item 7aa71 _h ! plan provid$ cov]age = su* products on ! same =mul>y ti] z ! ref]5ce product4 7dd7 ,a writt5 ju/ification = provid+ m favorable cov]age ( ! ref]5ce product ?an ! biosimil> biological product describ$ 9 item 7aa74 7ee7 ,! numb] ( curr5tly m>ket$ biosimil> biological products lic5s$ "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act1 pursuant to an application t ref]s to su* ref]5ce product4 7,v7 ,total gross sp5d+ on cov]$ "p ,d drugs by ! plan1 n net ( rebates1 fees1 disc\nts1 or o!r direct or indirect remun]ation4 7,,vi7 ,! total am\nt reta9$ by ! ph>macy b5efit manag] or an affiliate ( su* ph>macy b5efit manag] 9 rev5ue relat$ to utilization ( cov]$ "p ,d drugs "u t plan1 inclusive ( bona fide s]vice fees4 7,,vii7 ,! total sp5d+ on cov]$ "p ,d drugs net ( rebates1 fees1 disc\nts1 or o!r direct & indirect remun]ation by ! plan4 7,,viii7 ,an explanation ( any b5efit design p>amet]s "u su* plan t enc\rage plan enrollees to fill prescriptions at ph>macies t are an affiliate ( su* ph>macy b5efit manag]1 su* z mail & specialty home deliv]y programs1 & retail & mail auto-refill programs4 7,,ix7 ,! foll[+ in=mation3 7aa7 ,a li/ ( all brok]s1 consultants1 advisors1 & auditors t receive comp5sation f ! ph>macy b5efit manag] or an affiliate ( su* ph>macy b5efit manag] = ref]rals1 consult+1 audit+1 or o!r s]vices (f]$ to ,,pdp sponsors relat$ to ph>macy b5efit managem5t s]vices4 7bb7 ,! am\nt ( comp5sation provid$ by su* ph>macy b5efit manag] or affiliate to ea* su* brok]1 consultant1 advisor1 & auditor4 7cc7 ,! me?odology = calculat+ ! am\nt ( comp5sation provid$ by su* ph>macy b5efit manag] or affiliate1 = ea* su* brok]1 consultant1 advisor1 & auditor4 7,x7 ,a li/ ( all affiliates ( ! ph>macy b5efit manag]4 7,,xi7 ,a summ>y docum5t submitt$ 9 a /&>diz$ template develop$ by ! ,secret>y t includes su* in=mation describ$ 9 subclauses 7,i7 ?r\gh 7,x74 7ii7 ,writt5 explanation ( contracts or agreem5ts ) drug manufactur]s 7,i7 ,9 g5]al ,! ph>macy b5efit manag] %all1 n lat] ?an #cj days aft] ! f9alization ( any contract or agreem5t betwe5 su* ph>macy b5efit manag] or an affiliate ( su* ph>macy b5efit manag] & a drug manufactur] 7or subsidi>y1 ag5t1 or entity affiliat$ ) su* drug manufactur]7 t makes rebates1 disc\nts1 paym5ts1 or o!r f9ancial inc5tives relat$ to "o or m cov]$ "p ,d drugs or o!r prescription drugs1 z applicable1 ( ! manufactur] directly or indirectly cont+5t ^u cov]age1 =mul>y placem5t1 or utilization managem5t conditions on any o!r cov]$ "p ,d drugs or o!r prescription drugs1 z applicable1 submit to ! ,,pdp sponsor a writt5 explanation ( su* contract or agreem5t4 7,,ii7 ,requirem5ts ,a writt5 explanation "u subclause 7,i7 %all-- 7aa7 include ! manufactur] subject to ! contract or agreem5t1 all cov]$ "p ,d drugs & o!r prescription drugs1 z applicable1 subject to ! contract or agreem5t & ! manufactur]s ( su* drugs1 & a high-level description ( ! t]ms ( su* contract or agreem5t & h[ su* t]ms apply to su* drugs2 & 7bb7 be c]tifi$ by ! ,*ief ,executive ,(fic]1 ,*ief ,f9ancial ,(fic]1 or ,g5]al ,c\nsel ( su* ph>macy b5efit manag]1 or affiliate ( su* ph>macy b5efit manag]1 z applicable1 or an individual delegat$ ) ! au?ority to sign on behalf ( "o ( ^! (fic]s1 :o reports directly to ! (fic]4 7,,iii7 ,def9ition ( o!r prescription drugs ,= purposes ( ?is clause1 ! t]m o!r prescription drugs means prescription drugs cov]$ z supplem5tal b5efits "u ?is "p or prescription drugs paid outside ( ?is "p4 7,d7 ,audit rights 7i7 ,9 g5]al ,n less ?an once a ye>1 at ! reque/ ( ! ,,pdp sponsor1 ! ph>macy b5efit manag] %all all[ = an audit ( ! ph>macy b5efit manag] to ensure compliance ) all t]ms & conditions "u ! writt5 agreem5t describ$ 9 ?is p>agraph & ! accuracy ( in=mation report$ "u subp>agraph 7,c74 7ii7 ,auditor ,! ,,pdp sponsor %all h ! "r to select an auditor4 ,! ph>macy b5efit manag] %all n impose any limitations on ! selection ( su* auditor4 7iii7 ,provision ( in=mation ,! ph>macy b5efit manag] %all make available to su* auditor all records1 data1 contracts1 & o!r in=mation necess>y to confirm ! accuracy ( in=mation provid$ "u subp>agraph 7,c71 subject to reasonable re/rictions on h[ su* in=mation mu/ be report$ to prev5t r$isclosure ( su* in=mation4 7iv7 ,tim+ ,! ph>macy b5efit manag] mu/ provide in=mation "u clause 7iii7 & o!r in=mation1 data1 & records relevant to ! audit to su* auditor )9 #f mon?s ( ! initiation ( ! audit & respond to reque/s = additional in=mation f su* auditor )9 #cj days aft] ! reque/ = additional in=mation4 7v7 ,in=mation f affiliates ,! ph>macy b5efit manag] %all be responsible = provid+ to su* auditor in=mation requir$ to be report$ "u subp>agraph 7,c7 or "u clause 7iii7 ( ?is subp>agraph t is own$ or held by an affiliate ( su* ph>macy b5efit manag]4 7#b7 ,en=cem5t 7,a7 ,9 g5]al ,ea* ,,pdp sponsor %all-- 7i7 disgorge to ! ,secret>y any am\nts disgorg$ to ! ,,pdp sponsor by a ph>macy b5efit manag] "u p>agraph 7#a77;,a77v72 7ii7 require1 9 a writt5 agreem5t ) any ph>macy b5efit manag] act+ on behalf ( su* sponsor or affiliate ( su* ph>macy b5efit manag]1 t su* ph>macy b5efit manag] or affiliate reimburse ! ,,pdp sponsor = any civil money p5alty impos$ on ! ,,pdp sponsor z a result ( ! failure ( ! ph>macy b5efit manag] or affiliate to meet ! requirem5ts ( p>agraph 7#a7 t are applicable to ! ph>macy b5efit manag] or affiliate "u ! agreem5t2 & 7iii7 require1 9 a writt5 agreem5t ) any su* ph>macy b5efit manag] act+ on behalf ( su* sponsor or affiliate ( su* ph>macy b5efit manag]1 t su* ph>macy b5efit manag] or affiliate be subject to punitive rem$ies = brea* ( contract = failure to comply ) ! requirem5ts applicable "u p>agraph 7#a74 7,b7 ,report+ ( alleg$ violations ,! ,secret>y %all make available & ma9ta9 a me*anism = manufactur]s1 ,,pdp sponsors1 ph>macies1 & o!r entities t h contractual relation%ips ) ph>macy b5efit manag]s or affiliates ( su* ph>macy b5efit manag]s to report1 on a confid5tial basis1 alleg$ violations ( p>agraph 7#a77;,a7 or subp>agraph 7,c74 7,c7 ,anti-retaliation & anti-co]cion ,consi/5t ) applicable ,f$]al or ,/ate law1 a ,,pdp sponsor %all n-- 7i7 retaliate aga9/ an individual or entity = report+ an alleg$ violation "u subp>agraph 7,b72 or 7ii7 co]ce1 intimidate1 ?reat51 or int]f]e ) ! ability ( an individual or entity to report any su* alleg$ violations4 7#c7 ,c]tification ( compliance 7,a7 ,9 g5]al ,ea* ,,pdp sponsor %all furni% to ! ,secret>y 7at a "t & 9 a mann] specifi$ by ! ,secret>y7 an annual c]tification ( compliance ) ?is subsection1 z well z su* in=mation z ! ,secret>y det]m9es necess>y to c>ry out ?is subsection4 7,b7 ,implem5tation ,not)/&+ any o!r provision ( law1 ! ,secret>y may implem5t ?is p>agraph by program in/ruction or o!rwise4 7#d7 ,rule ( con/ruction ,no?+ 9 ?is subsection %all be con/ru$ z-- 7,a7 prohibit+ flat disp5s+ fees or reimbursem5t or paym5t = +r$i5t co/s 7includ+ cu/om>y1 indu/ry-/&>d disc\nts directly relat$ to drug acquisition t are reta9$ by ph>macies or :olesal]s7 to entities t acquire or disp5se prescription drugs2 or 7,b7 modify+ regulatory requirem5ts or sub-regulatory program in/ruction or guidance relat$ to ph>macy paym5t1 reimbursem5t1 or disp5s+ fees4 7#e7 ,/&>d =mats 7,a7 ,9 g5]al ,n lat] ?an ,june #a1 #bjbg1 ! ,secret>y %all specify /&>d1 ma*9e-readable =mats = ph>macy b5efit manag]s to submit annual reports requir$ "u p>agraph 7#a77;,c77i74 7,b7 ,implem5tation ,not)/&+ any o!r provision ( law1 ! ,secret>y may implem5t ?is p>agraph by program in/ruction or o!rwise4 7#f7 ,confid5tiality 7,a7 ,9 g5]al ,in=mation disclos$ by a ph>macy b5efit manag]1 an affiliate ( a ph>macy b5efit manag]1 a ,,pdp sponsor1 or a ph>macy "u ?is subsection t is n o!rwise publicly available or available = pur*ase %all n be disclos$ by ! ,secret>y or a ,,pdp sponsor receiv+ ! in=mation1 except t ! ,secret>y may disclose ! in=mation = ! foll[+ purposes3 7i7 ,z ! ,secret>y det]m9es necess>y to c>ry out ?is "p4 7ii7 ,to p]mit ! ,comptroll] ,g5]al to review ! in=mation provid$4 7iii7 ,to p]mit ! ,director ( ! ,congressional ,budget ,(fice to review ! in=mation provid$4 7iv7 ,to p]mit ! ,executive ,director ( ! ,m$ic>e ,paym5t ,advisory ,commission to review ! in=mation provid$4 7v7 ,to ! ,attorney ,g5]al = ! purposes ( conduct+ ov]sight & en=cem5t "u ?is title4 7vi7 ,to ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices 9 accordance ) its au?orities "u ! ,inspector ,g5]al ,act ( #aigh 7section #djf ( title #e1 ,unit$ ,/ates ,code71 & o!r applicable /atutes4 7,b7 ,re/riction on use ( in=mation ,! ,secret>y1 ! ,comptroll] ,g5]al1 ! ,director ( ! ,congressional ,budget ,(fice1 & ! ,executive ,director ( ! ,m$ic>e ,paym5t ,advisory ,commission %all n report on or disclose in=mation disclos$ pursuant to subp>agraph 7,a7 to ! public 9 a mann] t w\ld id5tify-- 7i7 a specific ph>macy b5efit manag]1 affiliate1 ph>macy1 manufactur]1 :olesal]1 ,,pdp sponsor1 or plan2 or 7ii7 contract prices1 rebates1 disc\nts1 or o!r remun]ation = specific drugs 9 a mann] t may all[ ! id5tification ( specific contract+ p>ties or ( su* specific drugs4 7#g7 ,def9itions ,= purposes ( ?is subsection3 7,a7 ,affiliate ,! t]m affiliate means1 ) respect to any ph>macy b5efit manag] or ,,pdp sponsor1 any entity t1 directly or indirectly-- 7i7 owns or is own$ by1 controls or is controll$ by1 or is o!rwise relat$ 9 any own]%ip /ructure to su* ph>macy b5efit manag] or ,,pdp sponsor2 or 7ii7 acts z a contractor1 pr9cipal1 or ag5t to su* ph>macy b5efit manag] or ,,pdp sponsor1 ins(> z su* contractor1 pr9cipal1 or ag5t p]=ms any ( ! functions describ$ "u subp>agraph 7,c74 7,b7 ,bona fide s]vice fee ,! t]m bona fide s]vice fee means a fee t is reflective ( ! fair m>ket value 7z specifi$ by ! ,secret>y1 ?r\gh notice & comm5t rulemak+7 = a bona fide1 itemiz$ s]vice actually p]=m$ on behalf ( an entity1 t ! entity w\ld o!rwise p]=m 7or contract =7 9 ! abs5ce ( ! s]vice arrangem5t & t is n pass$ on 9 :ole or 9 "p to a cli5t or cu/om]1 :e!r or n ! entity takes title to ! drug4 ,su* fee mu/ be a flat doll> am\nt & %all n be directly or indirectly bas$ on1 or cont+5t ^u-- 7i7 drug price1 su* z :olesale acquisition co/ or drug b5*m>k price 7su* z av]age :olesale price72 7ii7 ! am\nt ( disc\nts1 rebates1 fees1 or o!r direct or indirect remun]ation ) respect to cov]$ "p ,d drugs disp5s$ to enrollees 9 a prescription drug plan1 except z p]mitt$ pursuant to p>agraph 7#a77;,a77ii72 7iii7 cov]age or =mul>y placem5t decisions or ! volume or value ( any ref]rals or bus9ess g5]at$ betwe5 ! p>ties to ! arrangem5t2 or 7iv7 any o!r am\nts or me?odologies prohibit$ by ! ,secret>y4 7,c7 ,ph>macy b5efit manag] ,! t]m ph>macy b5efit manag] means any p]son or entity t1 ei!r directly or ?r\gh an int]m$i>y1 acts z a price negotiator or gr\p pur*as] on behalf ( a ,,pdp sponsor or prescription drug plan1 or manages ! prescription drug b5efits provid$ by su* sponsor or plan1 includ+ ! process+ & paym5t ( claims = prescription drugs1 ! p]=mance ( drug utilization review1 ! process+ ( drug prior au?orization reque/s1 ! adjudication ( appeals or grievances relat$ to ! prescription drug b5efit1 contract+ ) network ph>macies1 controll+ ! co/ ( cov]$ "p ,d drugs1 or ! provision ( relat$ s]vices4 ,su* t]m includes any p]son or entity t c>ries out "o or m ( ! activities describ$ 9 ! prec$+ s5t5ce1 irrespective ( :e!r su* p]son or entity calls itself a ph>macy b5efit manag]4 4 7#b7 ,,ma-,,pd plans ,section #aheg7;f77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;f77#c771 z am5d$ by section #bbf7;d77#b71 is am5d$ by add+ at ! end ! foll[+ new subp>agraph3 7,g7 ,requirem5ts relat+ to ph>macy b5efit manag]s ,= plan ye>s beg9n+ on or aft] ,janu>y #a1 #bjbh1 section #ahfj;,d-#ab7;h74 4 7#c7 ,nonapplication ( ,pap]work ,r$uction ,act ,*apt] #ce ( title #dd1 ,unit$ ,/ates ,code1 %all n apply to ! implem5tation ( ?is subsection4 7#d7 ,fund+ 7,a7 ,secret>y ,9 addition to am\nts o!rwise available1 !re is appropriat$ to ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices ,program ,managem5t ,acc\nt1 out ( any money 9 ! ,treasury n o!rwise appropriat$1 #aac1jjj1jjj = fiscal ye> #bjbe1 to rema9 available until exp5d$1 to c>ry out ?is subsection4 7,b7 ,,oig ,9 addition to am\nts o!rwise available1 !re is appropriat$ to ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 out ( any money 9 ! ,treasury n o!rwise appropriat$1 #bj1jjj1jjj = fiscal ye> #bjbe1 to rema9 available until exp5d$1 to c>ry out ?is subsection4 7b7 ,,gao ,/udy & ,report on ,price-,relat$ ,comp5sation ,across ! ,supply ,*a9 7#a7 ,/udy ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 79 ?is subsection ref]r$ to z ! ,comptroll] ,g5]al7 %all conduct a /udy describ+ ! use ( comp5sation & paym5t /ructures relat$ to a prescription drug's price )9 ! retail prescription drug supply *a9 9 "p ,d ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja et seq474 ,su* /udy %all summ>ize in=mation f ,f$]al ag5cies & indu/ry exp]ts1 to ! ext5t available1 ) respect to ! foll[+3 7,a7 ,! type1 magnitude1 o!r features 7su* z ! pric+ b5*m>ks us$71 & preval5ce ( comp5sation & paym5t /ructures relat$ to a prescription drug's price1 su* z calculat+ fee am\nts z a p]c5tage ( a prescription drug's price1 betwe5 int]m$i>ies 9 ! prescription drug supply *a91 includ+-- 7i7 ph>macy b5efit manag]s2 7ii7 ,,pdp sponsors (f]+ prescription drug plans & ,m$ic>e ,advantage organizations (f]+ ,,ma-,,pd plans2 7iii7 drug :olesal]s2 7iv7 ph>macies2 7v7 manufactur]s2 7vi7 ph>macy s]vices adm9i/rative organizations2 7vii7 brok]s1 auditors1 consultants1 & o!r entities t-- 7,i7 advise ,,pdp sponsors (f]+ prescription drug plans & ,m$ic>e ,advantage organizations (f]+ ,,ma-,,pd plans reg>d+ ph>macy b5efits2 or 7,,ii7 review ,,pdp sponsor & ,m$ic>e ,advantage organization contracts ) ph>macy b5efit manag]s2 & 7viii7 o!r s]vice provid]s t contract ) any ( ! entities describ$ 9 clauses 7i7 ?r\gh 7vii7 t may use price-relat$ comp5sation & paym5t /ructures1 su* z rebate aggregators 7or o!r entities t negotiate or process price concessions on behalf ( ph>macy b5efit manag]s1 plan sponsors1 or ph>macies74 7,b7 ,! prim>y bus9ess models & comp5sation /ructures = ea* category ( int]m$i>y describ$ 9 subp>agraph 7,a74 7,c7 ,v>iation 9 price-relat$ comp5sation /ructures betwe5 affiliat$ entities 7su* z entities ) common own]%ip1 ei!r full or p>tial1 & subsidi>y relation%ips7 & unaffiliat$ entities4 7,d7 ,pot5tial conflicts ( int]e/ among contract+ entities relat$ to ! use ( prescription drug price-relat$ comp5sation /ructures1 su* z ! pot5tial = fees or o!r paym5ts set z a p]c5tage ( a prescription drug's price to advantage =mul>y selection1 di/ribution1 or pur*as+ ( prescription drugs ) high] prices4 7,e7 ,notable diff]5ces1 if any1 9 ! use & level ( price-bas$ comp5sation /ructures ov] "t & betwe5 diff]5t m>ket segm5ts1 su* z "u "p ,d ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja et seq47 & ! ,m$icaid program "u title ,,xix ( su* ,act 7#db ,u4,s4,c4 #acif et seq474 7,f7 ,! effects ( drug price-relat$ comp5sation /ructures & alt]native comp5sation /ructures on ,f$]al heal? c>e programs & program b5efici>ies1 includ+ ) respect to co/-%>+1 premiums1 ,f$]al outlays1 biosimil> & g5]ic drug adoption & utilization1 drug %ortage risks1 & ! pot5tial = fees set z a p]c5tage ( a drug's price to advantage ! =mul>y selection1 di/ribution1 or pur*as+ ( drugs ) high] prices4 7,g7 ,o!r issues det]m9$ to be relevant & appropriate by ! ,comptroll] ,g5]al4 7#b7 ,report ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is section1 ! ,comptroll] ,g5]al %all submit to ,congress a report conta9+ ! results ( ! /udy conduct$ "u p>agraph 7#a71 toge!r ) recomm5dations = su* legislation & adm9i/rative action z ! ,comptroll] ,g5]al det]m9es appropriate4 7c7 ,med,p,a,c reports on agreem5ts ) ph>macy b5efit manag]s ) respect to prescription drug plans & ,,ma-,,pd plans 7#a7 ,9 g5]al ,! ,m$ic>e ,paym5t ,advisory ,commission %all submit to ,congress ! foll[+ reports3 7,a7 ,initial report ,n lat] ?an ! fir/ ,m>* #ae occurr+ aft] ! date t is #b ye>s aft] ! date on :i* ! ,secret>y makes ! data available to ! ,commission1 a report reg>d+ agreem5ts ) ph>macy b5efit manag]s ) respect to prescription drug plans & ,,ma-,,pd plans4 ,su* report %all include1 to ! ext5t practicable-- 7i7 a description ( tr5ds & patt]ns1 includ+ relevant av]ages1 totals1 & o!r figures = ! types ( in=mation submitt$2 7ii7 an analysis ( any diff]5ces 9 agreem5ts & _! effects on plan enrollee out-(-pocket sp5d+ & av]age ph>macy reimbursem5t1 & o!r impacts2 & 7iii7 any recomm5dations ! ,commission det]m9es appropriate4 7,b7 ,f9al report ,n lat] ?an #b ye>s aft] ! date on :i* ! ,commission submits ! initial report "u subp>agraph 7,a71 a report describ+ any *anges ) respect to ! in=mation describ$ 9 subp>agraph 7,a7 ov] "t1 toge!r ) any recomm5dations ! ,commission det]m9es appropriate4 7#b7 ,fund+ ,9 addition to am\nts o!rwise available1 !re is appropriat$ to ! ,m$ic>e ,paym5t ,advisory ,commission1 out ( any money 9 ! ,treasury n o!rwise appropriat$1 #a1jjj1jjj = fiscal ye> #bjbe1 to rema9 available until exp5d$1 to c>ry out ?is subsection4 #bbh4 ,requir+ a sep>ate id5tification numb] & an atte/ation = ea* (f-campus outpati5t dep>tm5t ( a provid] 7a7 ,9 g5]al ,section #ahcc7t7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#bc7 ,use ( unique heal? id5tifi]s2 atte/ation 7,a7 ,9 g5]al ,no paym5t may be made "u ?is subsection 7or "u an applicable paym5t sy/em pursuant to p>agraph 7#ba77 = items & s]vices furni%$ on or aft] ,janu>y #a1 #bjbf1 by an (f-campus outpati5t dep>tm5t ( a provid] 7z def9$ 9 subp>agraph 7,c77 unless-- 7i7 su* dep>tm5t has obta9$1 & su* items & s]vices are bill$ "u1 a /&>d unique heal? id5tifi] = heal? c>e provid]s 7z describ$ 9 section #aagc7;b77 t is sep>ate f su* id5tifi] = su* provid]2 7ii7 su* provid] has submitt$ to ! ,secret>y1 dur+ ! #b-ye> p]iod end+ on ! date su* items & s]vices are s furni%$1 an initial provid]-bas$ /atus atte/ation t su* dep>tm5t is compliant ) ! requirem5ts describ$ 9 section #dac4fe ( title #db1 ,code ( ,f$]al ,regulations 7or a successor regulation72 & 7iii7 aft] su* provid] has submitt$ an atte/ation "u clause 7ii71 su* provid] has submitt$ a subsequ5t atte/ation )9 ! timeframe specifi$ by ! ,secret>y4 7,b7 ,process = submission & review ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is p>agraph1 ! ,secret>y %all1 ?r\gh notice & comm5t rulemak+1 e/abli% a process = ea* provid] ) an (f-campus outpati5t dep>tm5t ( a provid] to submit an initial & subsequ5t atte/ation pursuant to clauses 7ii7 & 7iii71 respectively1 ( subp>agraph 7,a71 & = ! ,secret>y to review ea* su* atte/ation & det]m9e1 ?r\gh site visits1 remote audits1 or o!r means 7z det]m9$ appropriate by ! ,secret>y71 :e!r su* dep>tm5t is compliant ) ! requirem5ts describ$ 9 su* subp>agraph4 7,c7 ,(f-campus outpati5t dep>tm5t ( a provid] def9$ ,= purposes ( ?is p>agraph1 ! t]m (f-campus outpati5t dep>tm5t ( a provid] means a dep>tm5t ( a provid] 7z def9$ 9 section #dac4fe ( title #db1 ,code ( ,f$]al ,regulations1 or any successor regulation7 t is n locat$-- 7i7 on ! campus 7z def9$ 9 su* section7 ( su* provid]2 or 7ii7 )9 ! di/ance 7describ$ 9 su* def9ition ( campus7 f a remote location ( a hospital facility 7z def9$ 9 su* section74 4 7b7 ,,hhs ,,oig analysis ,n lat] ?an ,janu>y #a1 #bjcj1 ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all submit to ,congress-- 7#a7 an analysis ( ! process e/abli%$ by ! ,secret>y ( ,heal? & ,human ,s]vices to conduct ! reviews & det]m9ations describ$ 9 section #ahcc7t77#bc77;,b7 ( ! ,social ,security ,act1 z add$ by subsection 7a7 ( ?is section2 & 7#b7 recomm5dations bas$ on su* analysis1 z ! ,inspector ,g5]al det]m9es appropriate4 #bbi4 ,m$ic>e seque/ration ,section #bea;,a7#f7 ( ! ,balanc$ ,budget & ,em]g5cy ,deficit ,control ,act ( #aihe 7#b ,u4,s4,c4 #ija;a7#f77 is am5d$-- 7#a7 9 subp>agraph 7,d71 by /rik+ su* t1 & all t foll[s & ins]t+ su* t ! paym5t r$uction %all be #b4j p]c5t42 & 7#b7 by add+ at ! end ! foll[+3 7,f7 ,on ! date on :i* ! ,presid5t submits ! budget "u section #aaje ( title #ca1 ,unit$ ,/ates ,code1 = fiscal ye> #bjcc1 ! ,presid5t %all ord] a seque/ration ( paym5ts = ! ,m$ic>e programs specifi$ 9 section #bef7;d71 effective ^u issuance1 su* t1 not)/&+ ! #b p]c5t limit specifi$ 9 subp>agraph 7,a7 = su* paym5ts-- 7i7 ) respect to ! fir/ #b mon?s 9 :i* su* ord] is effective = su* fiscal ye>1 ! paym5t r$uction %all be #b4j p]c5t2 & 7ii7 ) respect to ! la/ #aj mon?s 9 :i* su* ord] is effective = su* fiscal ye>1 ! paym5t r$uction %all be #j p]c5t4 4 #bcj4 ,m$ic>e improvem5t fund ,section #ahih7;b77#a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;iii7b77#a77 is am5d$ by /rik+ #a1bea1jjj1jjj & ins]t+ #a1ich1jjj1jjj4 ,,iii ,human ,s]vices #cja4 ,sexual risk avoidance education ext5sion ,section #eaj ( ! ,social ,security ,act 7#db ,u4,s4,c4 #gaj7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#a7-- 7i7 by /rik+ & = ! p]iod & ins]t+ = ! p]iod2 7ii7 by ins]t+ = ! p]iod beg9n+ on ,april #a1 #bjbe1 & end+ on ,septemb] #cj1 #bjbe1 & = ! p]iod beg9n+ on ,octob] #a1 #bjbe1 & end+ on ,decemb] #ca1 #bjbe1 be=e allot to ea* ,/ate2 & 7iii7 by /rik+ = fiscal ye> #bjbd or #bjbe & ins]t+ = fiscal ye> #bjbd1 #bjbe1 or #bjbf2 & 7,b7 9 p>agraph 7#b71 by /rik+ or #bjbe ea* place x appe>s & ins]t+ 1 #bjbe1 or #bjbf2 & 7#b7 9 subsection 7f77#a71 by /rik+ & = ! p]iod beg9n+ on ,octob] #a1 #bjbd1 & end+ on ,m>* #ca1 #bjbe1 an am\nt equal to ! pro rata portion ( ! am\nt appropriat$ = ! correspond+ p]iod = fiscal ye> #bjbd & ins]t+ = ! p]iod beg9n+ on ,octob] #a1 #bjbd1 & end+ on ,m>* #ca1 #bjbe1 & = ! p]iod beg9n+ on ,april #a1 #bjbe1 & end+ on ,septemb] #cj1 #bjbe1 an am\nt equal to ! pro rata portion ( ! am\nt appropriat$ = ! correspond+ p]iod = fiscal ye> #bjbd1 & = ! p]iod beg9n+ on ,octob] #a1 #bjbe1 & end+ on ,decemb] #ca1 #bjbe1 an am\nt equal to ! pro rata portion ( ! am\nt appropriat$ = ! correspond+ p]iod = fiscal ye> #bjbe #cjb4 ,p]sonal responsibility education ext5sion ,section #eac ( ! ,social ,security ,act 7#db ,u4,s4,c4 #gac7 is am5d$-- 7#a7 9 subsection 7a77#a7-- 7,a7 9 subp>agraph 7,a71 9 ! matt] prec$+ clause 7i7-- 7i7 by /rik+ & = ! p]iod & ins]t+ = ! p]iod2 & 7ii7 by ins]t+ = ! p]iod beg9n+ on ,april #a1 #bjbe1 & end+ on ,septemb] #cj1 #bjbe1 & = ! p]iod beg9n+ on ,octob] #a1 #bjbe1 & end+ on ,decemb] #ca1 #bjbe1 be=e ! ,secret>y %all allot2 & 7,b7 9 subp>agraph 7,b77i7-- 7i7 by /rik+ & = ! p]iod & ins]t+ = ! p]iod2 & 7ii7 by ins]t+ 1 = ! p]iod beg9n+ on ,april #a1 #bjbe1 & end+ on ,septemb] #cj1 #bjbe1 & = ! p]iod beg9n+ on ,octob] #a1 #bjbe1 & end+ on ,decemb] #ca1 #bjbe be=e ! p]iod2 7#b7 9 subsection 7c77#c71 by /rik+ fiscal ye> #bjbd or #bjbe & ins]t+ fiscal ye> #bjbd1 #bjbe1 or #bjbf2 & 7#c7 9 subsection 7f71 by /rik+ & = ! p]iod beg9n+ on ,octob] #a1 #bjbd1 & end+ on ,m>* #ca1 #bjbe1 an am\nt equal to ! pro rata portion ( ! am\nt appropriat$ = ! correspond+ p]iod = fiscal ye> #bjbd & ins]t+ = ! p]iod beg9n+ on ,octob] #a1 #bjbd1 & end+ on ,m>* #ca1 #bjbe1 & = ! p]iod beg9n+ on ,april #a1 #bjbe1 & end+ on ,septemb] #cj1 #bjbe1 an am\nt equal to ! pro rata portion ( ! am\nt appropriat$ = ! correspond+ p]iod = fiscal ye> #bjbd1 & = ! p]iod beg9n+ on ,octob] #a1 #bjbe1 & end+ on ,decemb] #ca1 #bjbe1 an am\nt equal to ! pro rata portion ( ! am\nt appropriat$ = ! correspond+ p]iod = fiscal ye> #bjbe4 #cjc4 ,ext5sion ( fund+ = family-to-family heal? in=mation c5t]s ,section #eja7;c77#a77;,a77viii7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #gja7;c77#a77;,a77viii77 is am5d$-- 7#a7 by /rik+ #c1jjj1jjj & ins]t+ #g1ejj1jjj2 & 7#b7 by /rik+ = ! portion ( fiscal ye> #bjbe be=e ,april #a1 #bjbe & ins]t+ = ! p]iod beg9n+ on ,octob] #a1 #bjbd1 & end+ on ,decemb] #ca1 #bjbe4 ,,iv ,public heal? ext5d]s ,a ,ext5sions #dja4 ,ext5sion = community heal? c5t]s1 ,national ,heal? ,s]vice ,corps1 & tea*+ heal? c5t]s t op]ate ,,gme programs 7a7 ,ext5sion = community heal? c5t]s ,section #ajejc7;b77#a7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #bed;b-#b7;b77#a77 is am5d$-- 7#a7 9 subp>agraph 7,h71 by /rik+ & at ! end2 7#b7 9 subp>agraph 7,i71 by /rik+ ! p]iod & ins]t+ 1 & #b1cae1cdb1dff = ! p]iod beg9n+ on ,april #a1 #bjbe1 & end+ on ,septemb] #cj1 #bjbe2 &2 & 7#c7 by add+ at ! end ! foll[+3 7,j7 #d1fjj1jjj1jjj = fiscal ye> #bjbf2 & 4 7b7 ,ext5sion = ! ,national ,heal? ,s]vice ,corps ,section #ajejc7;b77#b7 ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #bed;b-#b7;b77#b77 is am5d$-- 7#a7 9 subp>agraph 7,i71 by /rik+ & at ! end2 7#b7 9 subp>agraph 7,j71 by /rik+ ! p]iod & ins]t+ 1 & #agf1gab1cbi = ! p]iod beg9n+ on ,april #a1 #bjbe1 & end+ on ,septemb] #cj1 #bjbe2 &2 & 7#c7 by add+ at ! end ! foll[+3 7,j7 #cej1jjj1jjj = fiscal ye> #bjbf4 4 7c7 ,tea*+ heal? c5t]s t op]ate graduate m$ical education programs ,section #cdj;,h7g77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;h7g77#a77 is am5d$-- 7#a7 9 subp>agraph 7,d71 by /rik+ 2 & & ins]t+ a semicolon2 7#b7 9 subp>agraph 7,e71 by /rik+ ! p]iod & ins]t+ a semicolon2 & 7#c7 by add+ at ! end ! foll[+3 7,f7 #aab1hdi1cae = ! p]iod beg9n+ on ,janu>y #a1 #bjbe1 & end+ on ,septemb] #cj1 #bjbe2 7,g7 #bbe1jjj1jjj = fiscal ye> #bjbf2 7,h7 #bej1jjj1jjj = fiscal ye> #bjbg2 7,i7 #bge1jjj1jjj = fiscal ye> #bjbh2 & 7,j7 #cjj1jjj1jjj = fiscal ye> #bjbi4 4 7d7 ,application ( provisions ,am\nts appropriat$ pursuant to ! am5dm5ts made by ?is section %all be subject to ! requirem5ts conta9$ 9 ,public ,law #aah-dg = funds = programs au?oriz$ "u sections #ccj ?r\gh #cdj ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bed;b et seq474 7e7 ,con=m+ am5dm5ts ,section #cjad7;h77#d7 ( title #ah1 ,unit$ ,/ates ,code1 is am5d$ by /rik+ & section #caja7;d7 ( ! ,heal? ,ext5sions & ,o!r ,matt]s ,act1 #bjbe & ins]t+ section #caja7;d7 ( ! ,heal? ,ext5sions & ,o!r ,matt]s ,act1 #bjbe1 & section #dja7;d7 ( ! ,bip>tisan ,heal? ,c>e ,act4 #djb4 ,ext5sion ( special diabetes programs 7a7 ,ext5sion ( special diabetes programs = type ,i diabetes ,section #ccj;,b7b77#b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bed;c-#b7;b77#b77 is am5d$-- 7#a7 9 subp>agraph 7,e71 by /rik+ & at ! end2 7#b7 9 subp>agraph 7,f71 by /rik+ ! p]iod at ! end & ins]t+ 1 & #aaj1cbg1bif = ! p]iod beg9n+ on ,april #a1 #bjbe1 & end+ on ,septemb] #cj1 #bjbe2 &2 & 7#c7 by add+ at ! end ! foll[+3 7,g7 #bjj1jjj1jjj = fiscal ye> #bjbf1 to rema9 available until exp5d$4 4 7b7 ,ext5d+ fund+ = special diabetes programs = ,indians ,section #ccj;,c7c77#b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bed;c-#c7;c77#b77 is am5d$-- 7#a7 9 subp>agraph 7,e71 by /rik+ & at ! end2 7#b7 9 subp>agraph 7,f71 by /rik+ ! p]iod at ! end & ins]t+ 1 & #aaj1cbg1bif = ! p]iod beg9n+ on ,april #a1 #bjbe1 & end+ on ,septemb] #cj1 #bjbe2 &2 & 7#c7 by add+ at ! end ! foll[+3 7,g7 #bjj1jjj1jjj = fiscal ye> #bjbf1 to rema9 available until exp5d$4 4 ,b ,_w ,trade ,c5t] ,heal? ,program #daa4 #i_/aa respond] & survivor heal? fund+ corrections 7a7 ,9 g5]al ,section #ccea7;a77#b77;,a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjmm-#fa7;a77#b77;,a77 is am5d$-- 7#a7 9 clause 7x71 by /rik+ 2 & & ins]t+ a semicolon2 7#b7 by r$esignat+ clause 7xi7 z clause 7xii72 & 7#c7 by ins]t+ aft] clause 7x71 ! foll[+3 7xi7 = ea* ( fiscal ye>s #bjbf ?r\gh #bjdj-- 7,i7 ! am\nt det]m9$ "u ?is subp>agraph = ! previ\s fiscal ye> multipli$ by #a4je2 multipli$ by 7,,ii7 ! ratio (-- 7aa7 ! total numb] ( individuals enroll$ 9 ! ,,wtc ,program on ,july #a ( su* previ\s fiscal ye>2 to 7bb7 ! total numb] ( individuals s enroll$ on ,july #a ( ! fiscal ye> prior to su* previ\s fiscal ye>2 & 4 7b7 ,report to ,congress 7#a7 ,9 g5]al ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is subsection z ! ,secret>y7 %all conduct an assessm5t ( anticipat$ budget au?ority & outlays ( ! ,_w ,trade ,c5t] ,heal? ,program 7ref]r$ to 9 ?is subsection z ! ,program7 ?r\gh ! duration ( ! ,program & submit a report summ>iz+ su* assessm5t to-- 7,a7 ! ,speak] & m9ority lead] ( ! ,h\se ( ,repres5tatives2 7,b7 ! majority & m9ority lead]s ( ! ,s5ate2 7,c7 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ! ,budget ( ! ,s5ate2 & 7,d7 ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ! ,budget ( ! ,h\se ( ,repres5tatives4 7#b7 ,inclusions ,! report requir$ "u p>agraph 7#a7 %all include-- 7,a7 a projection ( ,program budget>y ne$s on a p]-fiscal ye> basis ?r\gh fiscal ye> #bjij2 7,b7 a review ( ,program model+ = ea* ( fiscal ye>s #bjag ?r\gh ! fiscal ye> prior to ! fiscal ye> 9 :i* ! report is issu$ to assess h[ anticipat$ budget>y ne$s comp>$ to actual exp5ditures2 7,c7 an assessm5t ( ! project$ budget au?ority & exp5ditures ( ! ,program ?r\gh fiscal ye> #bjij by comp>+-- 7i7 su* project$ au?ority & exp5ditures result+ f application ( section #ccea7;a77#b77;,a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjmm-#fa7;a77#b77;,a771 z am5d$ by subsection 7a72 & 7ii7 su* project$ au?ority & exp5ditures t w\ld result if su* section 7 am5d$ s t ! =mula "u clause 7xi7 ( su* section1 z am5d$ by subsection 7a71 7 to be ext5d$ ?r\gh fiscal ye> #bjij2 & 7,d7 any recomm5dations ( ! ,secret>y to make *anges to ! =mula "u su* section #ccea7;a77#b77;,a71 z s am5d$1 to fully (fset anticipat$ ,program exp5ditures ?r\gh fiscal ye> #bjij4 7c7 ,te*nical am5dm5ts ,title ,,xxxiii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjmm et seq47 is am5d$-- 7#a7 9 section #cceb7;d7 7#db ,u4,s4,c4 #cjjmm-#fb7;d771 by /rik+ ,any am\nts & ins]t+ ,any unobligat$ am\nts2 7#b7 9 section #ccec7;d7 7#db ,u4,s4,c4 #cjjmm-#fc7;d771 by /rik+ ,any am\nts & ins]t+ ,any unobligat$ am\nts2 & 7#c7 9 section #cced7;d7 7#db ,u4,s4,c4 #cjjmm-#fd7;d771 by /rik+ ,any am\nts & ins]t+ ,any unobligat$ am\nts4 ,v ,,support ,act ,reau?orization #eja4 ,%ort title ,?is title may be cit$ z ! ,,support = ,pati5ts & ,communities ,reau?orization ,act ( #bjbe4 ,a ,prev5tion #eaa4 ,pr5atal & po/natal heal? ,section #cag,l7d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;b-#ac7;d77 is am5d$ by /rik+ su* sums z may be necess>y = ea* ( ! fiscal ye>s #bjai ?r\gh #bjbc & ins]t+ #d1bej1jjj = ea* ( fiscal ye>s #bjbe ?r\gh #bjbi4 #eab4 ,monitor+ & education reg>d+ infections associat$ ) illicit drug use & o!r risk factors ,section #cag,n7d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;b-#ae7;d77 is am5d$ by /rik+ fiscal ye>s #bjai ?r\gh #bjbc & ins]t+ fiscal ye>s #bjbe ?r\gh #bjbi4 #eac4 ,prev5t+ ov]doses ( controll$ sub/ances 7a7 ,9 g5]al ,section #cib;,a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;b-#a7 is am5d$-- 7#a7 9 subsection 7a77#b7-- 7,a7 9 subp>agraph 7,c71 by ins]t+ & associat$ risks be=e ! p]iod at ! end2 & 7,b7 9 subp>agraph 7,d71 by /rik+ opioids & ins]t+ sub/ances caus+ ov]dose2 & 7#b7 9 subsection 7b77#b7-- 7,a7 9 subp>agraph 7,b71 by ins]t+ 1 & associat$ risk factors1 aft] su* ov]doses2 7,b7 9 subp>agraph 7,c71 by /rik+ cod+ & ins]t+ monitor+ & id5tify+2 7,c7 9 subp>agraph 7,e7-- 7i7 by ins]t+ a comma aft] public heal? laboratories2 & 7ii7 by ins]t+ & o!r em]g+ sub/ances relat$ aft] analogues2 & 7,d7 9 subp>agraph 7,f71 by ins]t+ & associat$ risk factors aft] ov]doses4 7b7 ,additional grants ,section #cib;,a7a77#c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;b-#a7;a77#c77 is am5d$-- 7#a7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ & ,indian ,tribes-- & ins]t+ & ,indian ,tribes = ! foll[+ purposes32 7#b7 by am5d+ subp>agraph 7,a7 to read z foll[s3 7,a7 ,to c>ry out innovative projects = grantees to detect1 id5tify1 & rapidly respond to controll$ sub/ance misuse1 abuse1 & ov]doses1 & associat$ risk factors1 includ+ *anges 9 patt]ns ( su* controll$ sub/ance use4 ,su* projects may include ! use ( innovative1 evid5ce-bas$ /rategies = detect+ su* patt]ns1 su* z wa/ewat] surveillance1 if prov5 to support actionable prev5tion /rategies1 9 a mann] consi/5t ) applicable ,f$]al & ,/ate privacy laws4 2 & 7#c7 9 subp>agraph 7,b71 by /rik+ = any & ins]t+ ,= any4 7c7 ,au?orization ( appropriations ,section #cib;,a7e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;b-#a7;e77 is am5d$ by /rik+ #dif1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc & ins]t+ #eje1egi1jjj = ea* ( fiscal ye>s #bjbe ?r\gh #bjbi4 #ead4 ,support = individuals & families impact$ by fetal alcohol spectrum disord] 7a7 ,9 g5]al ,"p ,o ( title ,,iii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;f et seq47 is am5d$ to read z foll[s3 ,o ,fetal alcohol syndrome prev5tion & s]vices program #cii;,h4 ,fetal alcohol spectrum disord]s prev5tion1 int]v5tion1 & s]vices deliv]y program 7a7 ,9 g5]al ,! ,secret>y %all e/abli% or cont9ue activities to support a compreh5sive fetal alcohol spectrum disord]s 7ref]r$ to 9 ?is section z ,,fasd7 education1 prev5tion1 id5tification1 int]v5tion1 & s]vices deliv]y program1 :i* may include-- 7#a7 an education & public aw>5ess program to support1 conduct1 & evaluate ! effectiv5ess (-- 7,a7 educational programs t>get+ heal? pr(essions s*ools1 social & o!r supportive s]vices1 educators & c\nselors & o!r s]vice provid]s 9 all phases ( *ildhood developm5t1 & o!r relevant s]vice provid]s1 conc]n+ ! prev5tion1 id5tification1 & provision ( s]vices = infants1 *ildr51 adolesc5ts & adults ) ,,fasd2 7,b7 /rategies to educate s*ool-age *ildr51 includ+ pregnant & high-risk y\?1 conc]n+ ,,fasd2 7,c7 public & community aw>5ess programs conc]n+ ,,fasd2 & 7,d7 /rategies to coord9ate in=mation & s]vices across affect$ community ag5cies1 includ+ ag5cies provid+ social s]vices su* z fo/] c>e1 adoption1 & social "w1 ag5cies provid+ heal? s]vices1 & ag5cies involv$ 9 education1 vocational tra9+ & civil & crim9al ju/ice2 7#b7 support+ & conduct+ rese>* on ,,fasd1 z appropriate1 includ+ to-- 7,a7 develop appropriate m$ical diagno/ic me?ods = id5tify+ ,,fasd2 & 7,b7 develop effective culturally & l+ui/ically appropriate evid5ce-bas$ or evid5ce-in=m$ int]v5tions & appropriate supports = prev5t+ pr5atal alcohol exposure1 :i* may co-occur ) exposure to o!r sub/ances2 7#c7 build+ ,/ate & ,tribal capacity = ! id5tification1 treatm5t1 & support ( individuals ) ,,fasd & _! families1 :i* may include-- 7,a7 utiliz+ & adapt+ exi/+ ,f$]al1 ,/ate1 or ,tribal programs to include ,,fasd id5tification & ,,fasd-in=m$ support2 7,b7 develop+ & exp&+ scre5+ & diagno/ic capacity = ,,fasd2 7,c7 develop+1 implem5t+1 & evaluat+ t>get$ ,,fasd-in=m$ int]v5tion programs = ,,fasd2 7,d7 provid+ tra9+ ) respect to ,,fasd = pr(essionals across relevant sectors2 & 7,e7 dissem9at+ in=mation ab\t ,,fasd & support s]vices to affect$ individuals & _! families2 & 7#d7 an appli$ rese>* program conc]n+ int]v5tion & prev5tion to support & conduct s]vice demon/ration projects1 cl9ical /udies & o!r rese>* models provid+ advocacy1 educational & vocational tra9+1 c\nsel+1 m$ical & m5tal heal?1 & o!r supportive s]vices1 z well z models t integrate & coord9ate su* s]vices1 t are aim$ at ! unique *all5ges fac+ individuals ) ,fetal ,alcohol ,syndrome or ,fetal ,alcohol ,effect & _! families4 7b7 ,grants & ,te*nical ,assi/ance 7#a7 ,9 g5]al ,! ,secret>y may aw>d grants1 coop]ative agreem5ts & contracts & provide te*nical assi/ance to eligible entities to c>ry out subsection 7a74 7#b7 ,eligible entities ,to be eligible to receive a grant1 or ent] into a coop]ative agreem5t or contract1 "u ?is section1 an entity %all-- 7,a7 be a ,/ate1 ,indian ,tribe or ,tribal organization1 local gov]nm5t1 sci5tific or academic in/itution1 or nonpr(it organization2 & 7,b7 prep>e & submit to ! ,secret>y an application at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y may require1 includ+ a description ( ! activities t ! entity int5ds to c>ry out us+ am\nts receiv$ "u ?is section4 7#c7 ,additional application cont5ts ,! ,secret>y may require t an eligible entity include 9 ! application submitt$ "u p>agraph 7#b77;,b7-- 7,a7 a designation ( an individual to s]ve z a ,,fasd ,/ate or ,tribal coord9ator ( activities su* eligible entity proposes to c>ry out ?r\gh a grant1 coop]ative agreem5t1 or contract "u ?is section2 & 7,b7 a description ( an advisory committee ! entity w e/abli% to provide guidance = ! entity on develop+ & implem5t+ a /atewide or ,tribal /rategic plan to prev5t ,,fasd & provide = ! id5tification1 treatm5t1 & support ( individuals ) ,,fasd & _! families4 7c7 ,def9ition ( ,,fasd-,in=m$ ,= purposes ( ?is section1 ! t]m ,,fasd-in=m$1 ) respect to support or an int]v5tion program1 means t su* support or int]v5tion program uses culturally & l+ui/ically in=m$ evid5ce-bas$ or practice-bas$ int]v5tions & appropriate res\rces to support an improv$ quality ( life = an individual ) ,,fasd & ! family ( su* individual4 #cii;,i4 ,/r5g!n+ capacity & education = fetal alcohol spectrum disord]s 7a7 ,9 g5]al ,! ,secret>y %all aw>d grants1 contracts1 or coop]ative agreem5ts1 z ! ,secret>y det]m9es appropriate1 to public or nonpr(it private entities ) demon/rat$ exp]tise 9 ! field ( fetal alcohol spectrum disord]s 7ref]r$ to 9 ?is section z ,,fasd74 ,su* aw>ds %all be = ! purposes ( build+ local1 ,tribal1 ,/ate1 & nationwide capacities to prev5t ! occurr5ce ( ,,fasd by c>ry+ out ! programs describ$ 9 subsection 7b74 7b7 ,programs ,an entity receiv+ an aw>d "u subsection 7a7 may use su* aw>d = ! foll[+ purposes3 7#a7 ,develop+ & support+ public education & outrea* activities to raise public aw>5ess ( ! risks associat$ ) alcohol consumption dur+ pregnancy4 7#b7 ,act+ z a cle>+h\se = evid5ce-bas$ res\rces on ,,fasd prev5tion1 id5tification1 & culturally & l+ui/ically appropriate be/ practices to help in=m sy/ems ( c>e = individuals ) ,,fasd across _! lifespan4 7#c7 ,increas+ aw>5ess & und]/&+ ( efficaci\s1 evid5ce-bas$ scre5+ tools & culturally & l+ui/ically appropriate evid5ce-bas$ int]v5tion s]vices & be/ practices1 :i* may include improv+ ! capacity = ,/ate1 ,tribal1 & local affiliates4 7#d7 ,provid+ te*nical assi/ance to recipi5ts ( grants1 coop]ative agreem5ts1 or contracts "u section #cii;,h1 z appropriate4 7c7 ,application ,to be eligible = a grant1 contract1 or coop]ative agreem5t "u ?is section1 an entity %all submit to ! ,secret>y an application at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y may require4 7d7 ,subcontract+ ,a public or private nonpr(it entity may c>ry out ! foll[+ activities requir$ "u ?is section ?r\gh contracts or coop]ative agreem5ts ) o!r public & private nonpr(it entities ) demon/rat$ exp]tise 9 ,,fasd3 7#a7 ,res\rce developm5t & dissem9ation4 7#b7 ,int]v5tion s]vices4 7#c7 ,tra9+ & te*nical assi/ance4 #cii;,j4 ,au?orization ( appropriations ,!re are au?oriz$ to be appropriat$ to c>ry out ?is "p #ab1ejj1jjj = ea* ( fiscal ye>s #bjbe ?r\gh #bjbi4 4 7b7 ,report ,n lat] ?an #d ye>s aft] ! date ( enactm5t ( ?is ,act1 & e ye> !reaft]1 ! ,secret>y ( ,heal? & ,human ,s]vices %all prep>e & submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report conta9+-- 7#a7 a review ( ! activities c>ri$ out pursuant to sections #cii;,h & #cii;,i ( ! ,public ,heal? ,s]vice ,act1 z am5d$1 to advance public education & aw>5ess ( fetal alcohol spectrum disord]s 7ref]r$ to 9 ?is section z ,,fasd72 7#b7 a description (-- 7,a7 ! activities c>ri$ out pursuant to su* sections #cii;,h & #cii;,i to id5tify1 prev5t1 & treat ,,fasd2 & 7,b7 me?ods us$ to evaluate ! outcomes ( su* activities2 & 7#c7 an assessm5t ( activities c>ri$ out pursuant to su* sections #cii;,h & #cii;,i to support individuals ) ,,fasd4 #eae4 ,promot+ ,/ate *oice 9 ,,pdmp sy/ems ,section #cii,o7h7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;g-#c7;h77 is am5d$ by add+ at ! end ! foll[+3 7#e7 ,promot+ ,/ate *oice ,no?+ 9 ?is section %all be con/ru$ to au?orize ! ,secret>y to require ,/ates to use a specific v5dor or a specific int]op]ability connection o!r ?an to align ) nationally recogniz$1 cons5sus-bas$ op5 /&>ds1 su* z 9 accordance ) sections #cjja & #cjjd4 4 #eaf4 ,fir/ respond] tra9+ program ,section #edf ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;ee-#a7 is am5d$-- 7#a7 9 subsection 7a71 by /rik+ tribes & tribal & ins]t+ ,tribes & ,tribal2 7#b7 9 subsections 7a71 7c71 & 7d7-- 7,a7 by /rik+ approv$ or cle>$ ea* place x appe>s & ins]t+ approv$1 cle>$1 or o!rwise legally m>ket$2 & 7,b7 by /rik+ opioid ea* place x appe>s2 7#c7 9 subsection 7f7-- 7,a7 by /rik+ approv$ or cle>$ ea* place x appe>s & ins]t+ approv$1 cle>$1 or o!rwise legally m>ket$2 7,b7 9 p>agraph 7#a71 by /rik+ opioid2 7,c7 9 p>agraph 7#b7-- 7i7 by /rik+ opioid & h]o9 & ins]t+ opioid1 h]o91 & o!r drug2 & 7ii7 by /rik+ opioid ov]dose & ins]t+ ov]dose2 & 7,d7 9 p>agraph 7#c71 by /rik+ opioid & h]o92 & 7#d7 9 subsection 7h71 by /rik+ #cf1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc & ins]t+ #ef1jjj1jjj = ea* ( fiscal ye>s #bjbe ?r\gh #bjbi4 #eag4 ,donald ,j4 ,coh5 ,national ,*ild ,traumatic ,/ress ,initiative 7a7 ,te*nical am5dm5t ,! second "p ,g ( title ,v ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bijkk et seq471 z add$ by section #add ( ! ,community ,r5ewal ,tax ,relief ,act 7,public ,law #ajf-eed71 is am5d$-- 7#a7 by r$esignat+ su* "p z "p ,j2 & 7#b7 by r$esignat+ sections #eha ?r\gh #ehd z sections #eif ?r\gh #eif;,c1 respectively4 7b7 ,9 g5]al ,section #ehb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;hh-#a7 is am5d$-- 7#a7 9 ! section head+1 by /rik+ ,,viol5ce ,,relat$ ,,/ress & ins]t+ ,,traumatic ,,ev5ts2 7#b7 9 subsection 7a7-- 7,a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ tribes & tribal & ins]t+ ,tribes & ,tribal2 & 7,b7 9 p>agraph 7#b71 by ins]t+ & dissem9ation aft] ! developm5t2 7#c7 9 subsection 7b71 by ins]t+ & dissem9ation aft] ! developm5t2 7#d7 9 subsection 7d7-- 7,a7 by /rik+ ,! ,,nctsi & ins]t+ ! foll[+3 7#a7 ,coord9at+ c5t] ,! ,,nctsi 2 & 7,b7 by add+ at ! end ! foll[+3 7#b7 ,nctsi grantees ,9 c>ry+ out subsection 7a77#b71 ,,nctsi grantees %all develop tra9+s & o!r res\rces1 z applicable & appropriate1 to support implem5tation ( ! evid5ce-bas$ practices develop$ & dissem9at$ "u su* subsection4 2 7#e7 9 subsection 7e7-- 7,a7 by r$esignat+ p>agraphs 7#a7 & 7#b7 z subp>agraphs 7,a7 & 7,b71 respectively1 & adju/+ ! m>g9s accord+ly2 7,b7 9 subp>agraph 7,a71 z s r$esignat$1 by ins]t+ & implem5tation aft] ! dissem9ation2 7,c7 by /rik+ ,! ,,nctsi & ins]t+ ! foll[+3 7#a7 ,coord9at+ c5t] ,! ,,nctsi 2 & 7,d7 by add+ at ! end ! foll[+3 7#b7 ,nctsi grantees ,,nctsi grantees %all1 z appropriate1 collaborate ) o!r su* grantees1 ! ,,nctsi coord9at+ c5t]1 & ! ,secret>y 9 c>ry+ out subsections 7a77#b7 & 7d77#b74 2 7#f7 by am5d+ subsection 7h7 to read z foll[s3 7h7 ,application & evaluation ,to be eligible to receive a grant1 contract1 or coop]ative agreem5t "u subsection 7a71 a public or nonpr(it private entity or an ,indian ,tribe or ,tribal organization %all submit to ! ,secret>y an application at su* "t1 9 su* mann]1 & conta9+ su* in=mation & assurances z ! ,secret>y may require1 includ+-- 7#a7 a plan = ! evaluation ( ! activities fund$ "u ! grant1 contract1 or agreem5t1 includ+ bo? process & outcomes evaluation1 & ! submission ( an evaluation at ! end ( ! project p]iod2 & 7#b7 a description ( h[ su* entity1 ,indian ,tribe1 or ,tribal organization w support ef=ts l$ by ! ,secret>y or ! ,,nctsi coord9at+ c5t]1 z applicable1 to evaluate activities c>ri$ out "u ?is section4 2 & 7#g7 by am5d+ subsection 7j7 to read z foll[s3 7j7 ,au?orization ( appropriations ,!re is au?oriz$ to be appropriat$ to c>ry out ?is section-- 7#a7 #ic1hhg1jjj = fiscal ye> #bjbe2 7#b7 #ie1jjj1jjj = fiscal ye> #bjbf2 7#c7 #ig1jjj1jjj = fiscal ye> #bjbg2 7#d7 #ajj1jjj1jjj = fiscal ye> #bjbh2 & 7#e7 #ajj1jjj1jjj = fiscal ye> #bjbi4 4 #eah4 ,protect+ suicide prev5tion lifel9e f cyb]security incid5ts 7a7 ,national suicide prev5tion lifel9e program ,section #ebj;,e-#c7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;bb-#cf;c7b77 is am5d$-- 7#a7 9 p>agraph 7#d71 by /rik+ & at ! end2 7#b7 9 p>agraph 7#e71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7#f7 tak+ su* /eps z may be necess>y to ensure ! suicide prev5tion hotl9e is protect$ f cyb]security incid5ts & elim9ates kn[n cyb]security vuln]abilities4 4 7b7 ,report+ ,section #ebj;,e-#c ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;bb-#cf;c7 is am5d$-- 7#a7 by r$esignat+ subsection 7f7 z subsection 7g72 & 7#b7 by ins]t+ aft] subsection 7e7 ! foll[+3 7f7 ,cyb]security report+ 7#a7 ,notification 7,a7 ,9 g5]al ,! program's network adm9i/rator receiv+ ,f$]al fund+ pursuant to subsection 7a7 %all report to ! ,assi/ant ,secret>y1 9 a mann] t protects p]sonal privacy1 consi/5t ) applicable ,f$]al & ,/ate privacy laws-- 7i7 any id5tifi$ cyb]security vuln]abilities to ! program )9 a reasonable am\nt ( "t aft] id5tification ( su* a vuln]ability2 & 7ii7 any id5tifi$ cyb]security incid5ts to ! program )9 a reasonable am\nt ( "t aft] id5tification ( su* incid5t4 7,b7 ,local & regional crisis c5t]s ,local & regional crisis c5t]s p>ticipat+ 9 ! program %all report to ! program's network adm9i/rator id5tifi$ "u subp>agraph 7,a71 9 a mann] t protects p]sonal privacy1 consi/5t ) applicable ,f$]al & ,/ate privacy laws-- 7i7 any id5tifi$ cyb]security vuln]abilities to ! program )9 a reasonable am\nt ( "t aft] id5tification ( su* vuln]ability2 & 7ii7 any id5tifi$ cyb]security incid5ts to ! program )9 a reasonable am\nt ( "t aft] id5tification ( su* incid5t4 7#b7 ,notification ,if ! program's network adm9i/rator receiv+ fund+ pursuant to subsection 7a7 discov]s1 or is in=m$ by a local or regional crisis c5t] pursuant to p>agraph 7#a77;,b7 (1 a cyb]security vuln]ability or incid5t1 )9 a reasonable am\nt ( "t aft] su* discov]y or receipt ( in=mation1 su* entity %all report ! vuln]ability or incid5t to ! ,assi/ant ,secret>y4 7#c7 ,cl>ification 7,a7 ,ov]sight 7i7 ,local & regional crisis c5t]s ,except z provid$ 9 clause 7ii71 local & regional crisis c5t]s p>ticipat+ 9 ! program %all ov]see all te*nology ea* c5t] employs 9 ! provision ( s]vices z a p>ticipant 9 ! program4 7ii7 ,network adm9i/rator ,! program's network adm9i/rator receiv+ ,f$]al fund+ pursuant to subsection 7a7 %all ov]see ! te*nology ea* crisis c5t] employs 9 ! provision ( s]vices z a p>ticipant 9 ! program if su* ov]sight responsibilities are e/abli%$ 9 ! applicable network p>ticipation agreem5t4 7,b7 ,supplem5t1 n supplant ,! cyb]security incid5t report+ requirem5ts "u ?is subsection %all supplem5t1 & n supplant1 cyb]security incid5t report+ requirem5ts "u o!r provisions ( applicable ,f$]al law t are 9 effect on ! date ( ! enactm5t ( ! ,,support = ,pati5ts & ,communities ,reau?orization ,act ( #bjbe4 4 7c7 ,/udy ,n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all-- 7#a7 conduct & complete a /udy t evaluates cyb]security risks & vuln]abilities associat$ ) ! #i-h-h ,national ,suicide ,prev5tion ,lifel9e2 & 7#b7 submit a report on ! f9d+s ( su* /udy to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 #eai4 ,bruce's law 7a7 ,y\? prev5tion & recov]y ,section #gajb7;c7 ( ! ,,support = ,pati5ts & ,communities ,act 7#db ,u4,s4,c4 #bij;bb-#g;a7c77 is am5d$-- 7#a7 9 p>agraph 7#c77;,a77i71 by ins]t+ 1 :i* may include /rategies to increase education & aw>5ess ( ! pot5cy & dang]s ( syn!tic opioids 7includ+ drugs contam9at$ ) f5tanyl7 &1 z appropriate1 o!r em]g+ drug use or misuse issues be=e ! semicolon2 & 7#b7 9 p>agraph 7#d77;,a71 by ins]t+ & /rategies to increase education & aw>5ess ( ! pot5cy & dang]s ( syn!tic opioids 7includ+ drugs contam9at$ ) f5tanyl7 &1 z appropriate1 em]g+ drug use or misuse issues be=e ! semicolon4 7b7 ,int]dep>tm5tal sub/ance use disord]s coord9at+ committee ,section #gjbb ( ! ,,support = ,pati5ts & ,communities ,act 7#db ,u4,s4,c4 #bij;aa note7 is am5d$-- 7#a7 by /rik+ subsection 7g7 & ins]t+ ! foll[+3 7g7 ,work+ gr\ps 7#a7 ,9 g5]al ,! ,committee may e/abli% work+ gr\ps = purposes ( c>ry+ out ! duties describ$ 9 subsection 7e74 ,any su* work+ gr\p %all be compos$ ( memb]s ( ! ,committee 7or ! designees ( su* memb]s7 & may hold su* meet+s z are necess>y to c>ry out ! duties delegat$ to ! work+ gr\p4 7#b7 ,additional f$]al int]ag5cy "w gr\p on f5tanyl contam9ation ( illegal drugs 7,a7 ,e/abli%m5t ,! ,secret>y1 act+ ?r\gh ! ,committee1 %all e/abli% a ,f$]al ,int]ag5cy ,"w ,gr\p on ,f5tanyl ,contam9ation ( ,illegal ,drugs 7ref]r$ to 9 ?is p>agraph z ! ,"w ,gr\p7 consi/+ ( repres5tatives f relevant ,f$]al dep>tm5ts & ag5cies on ! ,committee4 7,b7 ,consultation ,! ,"w ,gr\p %all consult ) relevant /akehold]s & subject matt] exp]ts1 includ+-- 7i7 ,/ate1 ,tribal1 & local subject matt] exp]ts 9 r$uc+1 prev5t+1 & respond+ to drug ov]dose caus$ by f5tanyl-contam9ation ( illicit drugs2 & 7ii7 family memb]s ( bo? adults & y\? :o h ov]dos$ by f5tanyl-contam9at$ illicit drugs4 7,c7 ,duties ,! ,"w ,gr\p %all-- 7i7 exam9e ,f$]al ef=ts to r$uce & prev5t drug ov]dose by f5tanyl-contam9at$ illicit drugs2 7ii7 id5tify /rategies to improve ,/ate1 ,tribal1 & local responses to ov]dose by f5tanyl-contam9at$ illicit drugs2 7iii7 coord9ate ) ! ,secret>y1 z appropriate1 9 c>ry+ out activities to raise public aw>5ess ( syn!tic opioids & o!r em]g+ drug use & misuse issues2 7iv7 make recomm5dations to ,congress = improv+ ,f$]al programs1 includ+ ) respect to ! coord9ation ( ef=ts across su* programs2 & 7v7 make recomm5dations = educat+ y\? on ! pot5cy & dang]s ( drugs contam9at$ by f5tanyl4 7,d7 ,annual report to secret>y ,! ,"w ,gr\p %all annually prep>e & submit to ! ,secret>y1 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate1 & ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,education & ! ,work=ce ( ! ,h\se ( ,repres5tatives1 a report on ! activities c>ri$ out by ! ,"w ,gr\p "u subp>agraph 7,c71 includ+ recomm5dations to r$uce & prev5t drug ov]dose by f5tanyl contam9ation ( illegal drugs1 9 all populations1 & specifically among y\? at risk = sub/ance misuse4 2 & 7#b7 by /rik+ subsection 7i7 & ins]t+ ! foll[+3 7i7 ,sunset ,! ,committee %all t]m9ate on ,septemb] #cj1 #bjbi4 4 #ebj4 ,guidance on at-home drug disposal sy/ems 7a7 ,9 g5]al ,n lat] ?an "o ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 9 consultation ) ! ,adm9i/rator ( ! ,drug ,en=cem5t ,adm9i/ration1 %all publi% guidance to facilitate ! use ( at-home safe disposal sy/ems = applicable drugs4 7b7 ,cont5ts ,! guidance "u subsection 7a7 %all include-- 7#a7 recomm5d$ /&>ds = effective at-home drug disposal sy/ems to meet applicable requirem5ts en=c$ by ! ,food & ,drug ,adm9i/ration2 7#b7 recomm5d$ in=mation to include z in/ructions = use to dissem9ate ) at-home drug disposal sy/ems2 7#c7 be/ practices & educational tools to support ! use ( an at-home drug disposal sy/em1 z appropriate2 & 7#d7 recomm5d$ use ( lic5s$ heal? provid]s = ! dissem9ation ( education1 in/ruction1 & at-home drug disposal sy/ems1 z appropriate4 #eba4 ,assessm5t ( opioid drugs & actions 7a7 ,9 g5]al ,n lat] ?an "o ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all publi% on ! website ( ! ,food & ,drug ,adm9i/ration 7ref]r$ to 9 ?is section z ! ,,fda7 a report t outl9es a plan = assess+ opioid analgesic drugs t are approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 t addresses ! public heal? effects ( su* opioid analgesic drugs z "p ( ! b5efit-risk assessm5t & ! activities ( ! ,,fda t relate to facilitat+ ! developm5t ( nonaddictive m$ical products int5d$ to treat pa9 or addiction4 ,su* report %all include-- 7#a7 an update on ! actions tak5 by ! ,,fda to consid] ! effectiv5ess1 safety1 b5efit-risk pr(ile1 & use ( approv$ opioid analgesic drugs2 7#b7 a timel9e = an assessm5t ( ! pot5tial ne$1 z appropriate1 = label+ *anges1 revis$ or additional po/m>ket+ requirem5ts1 en=cem5t actions1 or )drawals = opioid analgesic drugs2 7#c7 an ov]view ( ! /eps t ! ,,fda has tak5 to support ! developm5t & approval ( nonaddictive m$ical products int5d$ to treat pa9 or addiction1 & actions plann$ to fur!r support ! developm5t & approval ( su* products2 & 7#d7 an ov]view ( ! consid]ation by ! ,,fda ( cl9ical trial me?odologies = analgesic drugs1 includ+ ! enri*$ enrollm5t r&omiz$ )drawal me?odology1 & ! b5efits & drawbacks associat$ ) diff]5t trial me?odologies = su* drugs1 incorporat+ any public input receiv$ "u subsection 7b74 7b7 ,public input ,9 c>ry+ out subsection 7a71 ! ,secret>y %all provide an opportunity = public input conc]n+ ! regulation by ! ,,fda ( opioid analgesic drugs1 includ+ sci5tific evid5ce t relates to conditions ( use1 safety1 or b5efit-risk assessm5t 7includ+ consid]ation ( ! public heal? effects7 ( su* opioid analgesic drugs4 #ebb4 ,grant program = ,/ate & ,tribal response to opioid use disord]s ,! activities c>ri$ out pursuant to section #ajjc7;b77#d77;,a7 ( ! #ba/ ,c5tury ,cures ,act 7#db ,u4,s4,c4 #bij;ee-#c;a7b77#d77;,a77 may include facilitat+ access to products us$ to prev5t ov]dose dea?s by detect+ ! pres5ce ( "o or m sub/ances1 su* z f5tanyl & xylaz9e te/ /rips1 to ! ext5t ! pur*ase & possession ( su* products is consi/5t ) ,f$]al & ,/ate law4 ,b ,treatm5t #eca4 ,resid5tial treatm5t program = pregnant & po/p>tum wom5 ,section #ejh ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;bb-#a7 is am5d$-- 7#a7 9 subsection 7d77#aa77;,c71 by /rik+ provid+ heal? s]vices & ins]t+ provid+ heal? c>e s]vices2 7#b7 9 subsection 7g7-- 7,a7 by ins]t+ a plan describ+ aft] w provide2 & 7,b7 by add+ at ! end ! foll[+3 ,su* plan may include a description ( h[ su* applicant w t>get outrea* to wom5 disproportionately impact$ by mat]nal sub/ance use disord]42 & 7#c7 9 subsection 7s71 by /rik+ #bi1ica1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc & ins]t+ #ch1ica1jjj = ea* ( fiscal ye>s #bjbe ?r\gh #bjbi4 #ecb4 ,improv+ access to addiction m$ic9e provid]s ,section #eig ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bijll7 is am5d$-- 7#a7 9 subsection 7a77#a71 by ins]t+ diagnosis1 aft] relat$ to2 & 7#b7 9 subsection 7b71 by ins]t+ addiction m$ic9e1 aft] psy*iatry14 #ecc4 ,m5tal & behavioral heal? education & tra9+ grants ,section #gef7;f7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bid;e-#a7;f77 is am5d$ by /rik+ fiscal ye>s #bjbc ?r\gh #bjbg & ins]t+ fiscal ye>s #bjbe ?r\gh #bjbi4 #ecd4 ,loan repaym5t program = sub/ance use disord] treatm5t work=ce ,section #gha7;j7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bie;h7j77 is am5d$ by /rik+ #be1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc & ins]t+ #dj1jjj1jjj = ea* ( fiscal ye>s #bjbe ?r\gh #bjbi4 #ece4 ,developm5t & dissem9ation ( model tra9+ programs = sub/ance use disord] pati5t records ,section #gjec ( ! ,,support = ,pati5ts & ,communities ,act 7#db ,u4,s4,c4 #bij;dd-#b note7 is am5d$ by /rik+ subsection 7e74 #ecf4 ,task =ce on be/ practices = trauma-in=m$ id5tification1 ref]ral1 & support ,section #gacb ( ! ,,support = ,pati5ts & ,communities ,act 7,public ,law #aae-bga2 #acb ,/at4 #djdf7 is am5d$-- 7#a7 9 subsection 7b77#a7-- 7,a7 by r$esignat+ subp>agraph 7,,cc7 z subp>agraph 7,,dd72 & 7,b7 by ins]t+ aft] subp>agraph 7,,bb7 ! foll[+3 7,,cc7 ,! ,adm9i/ration = ,community ,liv+4 2 7#b7 9 subsection 7d77#a71 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ 1 developm5tal disability s]vice provid]s be=e 1 individuals :o are2 & 7#c7 9 subsection 7i71 by /rik+ #bjbc & ins]t+ #bjbi4 #ecg4 ,grants to enhance access to sub/ance use disord] treatm5t ,section #cbjc ( ! ,,support = ,pati5ts & ,communities ,act 7#ba ,u4,s4,c4 #hbc note7 is am5d$-- 7#a7 by /rik+ subsection 7b72 & 7#b7 by /rik+ 7a7 ,9 g5]al4--,! ,secret>y & ins]t+ ! foll[+3 ,! ,secret>y4 #ech4 ,/ate guidance relat$ to individuals ) s]i\s m5tal illness & *ildr5 ) s]i\s emotional di/urbance 7a7 ,review ( use ( c]ta9 fund+ ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y71 act+ ?r\gh ! ,assi/ant ,secret>y = ,m5tal ,heal? & ,sub/ance ,use1 %all conduct a review ( ,/ate use ( funds made available "u ! ,community ,m5tal ,heal? ,s]vices ,block ,grant program "u subp>t ,i ( "p ,b ( title ,,xix ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjx et seq47 7ref]r$ to 9 ?is section z ! block grant program7 = fir/ episode psy*osis activities4 ,su* review %all consid] ! foll[+3 7#a7 ,h[ ,/ates use funds = evid5ce-bas$ treatm5ts & s]vices accord+ to ! /&>d ( c>e = individuals ) e>ly s]i\s m5tal illness & *ildr5 ) a s]i\s emotional di/urbance4 7#b7 ,! p]c5tages ( ! ,/ate fund+ "u ! block grant program exp5d$ on e>ly s]i\s m5tal illness & fir/ episode psy*osis1 & ! numb] ( individuals s]v$ "u su* funds4 7b7 ,report & guidance 7#a7 ,report ,n lat] ?an #ahj days aft] ! completion ( ! review "u subsection 7a71 ! ,secret>y %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives a report describ+-- 7,a7 ! f9d+s ( ! review "u subsection 7a72 & 7,b7 any recomm5dations = *anges to ! block grant program t w\ld facilitate improv$ outcomes = individuals ) s]i\s m5tal illness & *ildr5 ) s]i\s emotional di/urbance4 7#b7 ,guidance ,n lat] ?an #a ye> aft] ! date on :i* ! report is submitt$ "u p>agraph 7#a71 ! ,secret>y %all update ! guidance provid$ to ,/ates "u ! block grant program on coord9at$ specialty c>e & o!r evid5ce-bas$ m5tal heal? c>e s]vices = individuals ) s]i\s m5tal illness & *ildr5 ) a s]i\s emotional di/urbance1 bas$ on ! f9d+s & recomm5dations ( su* report4 #eci4 ,review+ ! s*$ul+ ( approv$ products conta9+ a comb9ation ( bupr5orph9e & naloxone 7a7 ,secret>y ( ,,hhs ,! ,secret>y ( ,heal? & ,human ,s]vices %all1 consi/5t ) ! requirem5ts & proc$ures set =? 9 sections #bja & #bjb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #haa1 #hab7-- 7#a7 review ! relevant data p]ta9+ to ! s*$ul+ ( products conta9+ a comb9ation ( bupr5orph9e & naloxone t h be5 approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee72 & 7#b7 if appropriate1 reque/ t ! ,attorney ,g5]al initiate rulemak+ proce$+s to revise ! s*$ules accord+ly ) respect to su* products4 7b7 ,attorney g5]al ,! ,attorney ,g5]al %all review any reque/ made by ! ,secret>y ( ,heal? & ,human ,s]vices "u subsection 7a77#b7 & det]m9e :e!r to initiate proce$+s to revise ! s*$ules 9 accordance ) ! crit]ia set =? 9 sections #bja & #bjb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #haa1 #hab74 ,c ,recov]y #eda4 ,build+ communities ( recov]y ,section #edg7;f7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;ee-#b7;f77 is am5d$ by /rik+ #e1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc & ins]t+ #af1jjj1jjj = ea* ( fiscal ye>s #bjbe ?r\gh #bjbi4 #edb4 ,pe] support te*nical assi/ance c5t] ,section #edg;,a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;ee-#b;a7 is am5d$-- 7#a7 9 subsection 7b77#d71 by /rik+ build+2 & & ins]t+ ! foll[+3 build+1 su* z-- 7,a7 pr(essional developm5t ( pe] support speciali/s2 & 7,b7 mak+ recov]y support s]vices available 9 noncl9ical sett+s2 & 2 7#b7 by r$esignat+ subsections 7d7 & 7e7 z subsections 7e7 & 7f71 respectively2 7#c7 by ins]t+ aft] subsection 7c7 ! foll[+3 7d7 ,regional c5t]s 7#a7 ,9 g5]al ,! ,secret>y may e/abli% "o regional te*nical assi/ance c5t] 7ref]r$ to 9 ?is subsection z ! ,regional ,c5t]71 ) exi/+ res\rces1 to assi/ ! ,c5t] 9 c>ry+ out activities describ$ 9 subsection 7b7 )9 ! geographic region ( su* ,regional ,c5t] 9 a mann] t is tailor$ to ! ne$s ( su* region4 7#b7 ,evaluation ,n lat] ?an #d ye>s aft] ! date ( enactm5t ( ! ,,support = ,pati5ts & ,communities ,reau?orization ,act ( #bjbe1 ! ,secret>y %all evaluate ! activities ( ! ,regional ,c5t] & submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report on ! f9d+s ( su* evaluation1 includ+-- 7,a7 a description ( ! di/9ct roles & responsibilities ( ! ,regional ,c5t] & ! ,c5t]2 7,b7 available in=mation relat+ to ! outcomes ( ! ,regional ,c5t] "u ?is subsection1 su* z any impact on ! op]ations & effici5cy ( ! ,c5t] relat+ to reque/s = te*nical assi/ance & support )9 ! region ( su* ,regional ,c5t]2 7,c7 a description ( any gaps or areas ( duplication relat+ to ! activities ( ! ,regional ,c5t] & ! ,c5t] )9 su* region2 & 7,d7 recomm5dations relat+ to ! modification1 expansion1 or t]m9ation ( ! ,regional ,c5t] "u ?is subsection4 7#c7 ,t]m9ation ,?is subsection %all t]m9ate on ,septemb] #cj1 #bjbi4 2 & 7#d7 9 subsection 7f71 z s r$esignat$1 by /rik+ #a1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc & ins]t+ #b1jjj1jjj = ea* ( fiscal ye>s #bjbe ?r\gh #bjbi4 #edc4 ,compreh5sive opioid recov]y c5t]s ,section #eeb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bij;ee-#g7 is am5d$-- 7#a7 9 subsection 7d77#b7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ & 9 su* mann] & ins]t+ 1 9 su* mann]1 & conta9+ su* in=mation & assurances1 includ+ relevant docum5tation12 & 7,b7 9 subp>agraph 7,a71 by /rik+ is capable ( coord9at+ ) o!r entities to c>ry out & ins]t+ has ! demon/rat$ capability to c>ry out1 ?r\gh ref]ral or contractual arrangem5ts2 7#b7 9 subsection 7h7-- 7,a7 by r$esignat+ p>agraphs 7#a7 ?r\gh 7#d7 z subp>agraphs 7,a7 ?r\gh 7,d71 respectively1 & adju/+ ! m>g9s accord+ly2 7,b7 by /rik+ ,) respect to & ins]t+ ! foll[+3 7#a7 ,9 g5]al ,) respect to 2 & 7,c7 by add+ at ! end ! foll[+3 7#b7 ,additional report+ = c]ta9 eligible entities ,an entity c>ry+ out activities describ$ 9 subsection 7g7 ?r\gh ref]ral or contractual arrangem5ts %all include 9 ! submissions requir$ "u p>agraph 7#a7 in=mation relat$ to ! /atus ( su* ref]rals or contractual arrangem5ts1 includ+ an assessm5t ( :e!r su* ref]rals or contractual arrangem5ts are support+ ! ability ( su* entity to c>ry out su* activities4 2 & 7#c7 9 subsection 7j71 by /rik+ #bjai ?r\gh #bjbc & ins]t+ #bjbe ?r\gh #bjbi4 #edd4 ,y\? prev5tion & recov]y ,section #gajb7;c7 ( ! ,,support = ,pati5ts & ,communities ,act 7#db ,u4,s4,c4 #bij;bb-#g;a7c77 7z am5d$ by section #aaj7;a77 is am5d$-- 7#a7 9 p>agraph 7#b7-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 clause 7i7-- 7,i7 by ins]t+ 1 or a consortium ( local educational ag5cies1 aft] a local educational ag5cy2 & 7,,ii7 by /rik+ high s*ools & ins]t+ second>y s*ools2 & 7ii7 9 clause 7vi71 by /rik+ tribe1 or tribal & ins]t+ ,tribe1 or ,tribal2 7,b7 by am5d+ subp>agraph 7,e7 to read z foll[s3 7,e7 ,indian tribe2 tribal organization ,! t]ms ,indian ,tribe & ,tribal organization h ! mean+s giv5 su* t]ms 9 section #d ( ! ,indian ,self-,det]m9ation & ,education ,assi/ance ,act 7#be ,u4,s4,c4 #ecjd74 2 7,c7 by r$esignat+ subp>agraph 7,k7 z subp>agraph 7,l72 & 7,d7 by ins]t+ aft] subp>agraph 7,j7 ! foll[+3 7,k7 ,second>y s*ool ,! t]m second>y s*ool has ! mean+ giv5 su* t]m 9 section #haja ( ! ,elem5t>y & ,second>y ,education ,act ( #aife 7#bj ,u4,s4,c4 #ghja74 2 7#b7 9 p>agraph 7#c77;,a71 9 ! matt] prec$+ clause 7i7-- 7,a7 by /rik+ & abuse2 & 7,b7 by ins]t+ at increas$ risk = sub/ance misuse aft] specific populations2 7#c7 9 p>agraph 7#d7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ ,indian tribes & ins]t+ ,indian ,tribes2 7,b7 9 subp>agraph 7,a71 by /rik+ & abuse2 & 7,c7 9 subp>agraph 7,b71 by /rik+ pe] m5tor+ & ins]t+ pe]-to-pe] support2 7#d7 9 p>agraph 7#e71 by /rik+ tribal & ins]t+ ,tribal2 7#e7 9 p>agraph 7#f77;,a7-- 7,a7 9 clause 7iv71 by /rik+ 2 & & ins]t+ a semicolon2 & 7,b7 by add+ at ! end ! foll[+3 7vi7 a plan to su/a9 ! activities c>ri$ out "u ! grant program1 aft] ! grant program has end$2 & 2 7#f7 9 p>agraph 7#h71 by /rik+ #bjbb & ins]t+ #bjbg2 & 7#g7 by am5d+ p>agraph 7#i7 to read z foll[s3 7#i7 ,au?orization ( appropriations ,to c>ry out ?is subsection1 !re are au?oriz$ to be appropriat$-- 7,a7 #aj1jjj1jjj = fiscal ye> #bjbe2 7,b7 #ab1jjj1jjj = fiscal ye> #bjbf2 7,c7 #ac1jjj1jjj = fiscal ye> #bjbg2 7,d7 #ad1jjj1jjj = fiscal ye> #bjbh2 & 7,e7 #ae1jjj1jjj = fiscal ye> #bjbi4 4 #ede4 ,,c>e] ,act 7a7 ,9 g5]al ,section #gahc ( ! ,,support = ,pati5ts & ,communities ,act 7#db ,u4,s4,c4 #bij;ee-#h7 is am5d$-- 7#a7 9 ! section head+1 by ins]t+ 2 ,,treatm5t1 ,,recov]y1 ,,& ,,work=ce ,,support ,,grants aft] ,,c>e] ,,act2 7#b7 9 subsection 7b71 by ins]t+ ea* be=e = a p]iod2 7#c7 9 subsection 7c7-- 7,a7 9 p>agraph 7#a71 by /rik+ ! rates describ$ 9 p>agraph 7#b7 & ins]t+ ! av]age rates = cal5d> ye>s #bjah ?r\gh #bjbb describ$ 9 p>agraph 7#b72 & 7,b7 by am5d+ p>agraph 7#b7 to read z foll[s3 7#b7 ,rates ,! rates describ$ 9 ?is p>agraph are ! foll[+3 7,a7 ,! highe/ age-adju/$ av]age rates ( drug ov]dose dea?s = cal5d> ye>s #bjah ?r\gh #bjbb bas$ on data f ! ,c5t]s = ,disease ,control & ,prev5tion1 includ+1 if necess>y1 provisional data = cal5d> ye> #bjbb4 7,b7 ,! highe/ av]age rates ( unemploym5t = cal5d> ye>s #bjah ?r\gh #bjbb bas$ on data provid$ by ! ,bureau ( ,labor ,/ati/ics4 7,c7 ,! l[e/ av]age labor =ce p>ticipation rates = cal5d> ye>s #bjah ?r\gh #bjbb bas$ on data provid$ by ! ,bureau ( ,labor ,/ati/ics4 2 7#d7 9 subsection 7g7-- 7,a7 9 ea* ( p>agraphs 7#a7 & 7#c71 by r$esignat+ subp>agraphs 7,a7 & 7,b7 z clauses 7i7 & 7ii71 respectively1 & adju/+ ! m>g9s accord+ly2 7,b7 by r$esignat+ p>agraphs 7#a7 ?r\gh 7#c7 z subp>agraphs 7,a7 ?r\gh 7,c71 respectively1 & adju/+ ! m>g9s accord+ly2 7,c7 9 ! matt] prec$+ subp>agraph 7,a7 7z s r$esignat$71 by /rik+ ,an entity & ins]t+ ! foll[+3 7#a7 ,9 g5]al ,an entity 2 & 7,d7 by add+ at ! end ! foll[+3 7#b7 ,transportation s]vices ,an entity receiv+ a grant "u ?is section may use n m ?an #e p]c5t ( ! funds = provid+ transportation = individuals to p>ticipate 9 an activity support$ by a grant "u ?is section1 :i* transportation %all be to or f a place ( "w or a place :]e ! individual is receiv+ vocational education or job tra9+ s]vices or receiv+ s]vices directly l9k$ to treatm5t ( or recov]y f a sub/ance use disord]4 7#c7 ,limitation ,! ,secret>y may n require an entity to1 or give priority to an entity t plans to1 use ! funds ( a grant "u ?is section = activities t are n specifi$ 9 ?is subsection4 2 7#e7 9 subsection 7i77#b71 by ins]t+ 1 :i* %all include employm5t & e>n+s outcomes describ$ 9 subclauses 7,i7 & 7,,iii7 ( section #aaf7;b77#b77;,a77i7 ( ! ,work=ce ,innovation & ,opportunity ,act 7#bi ,u4,s4,c4 #cada7;b77#b77;,a77i77 ) respect to ! p>ticipation ( su* individuals ) a sub/ance use disord] 9 programs & activities fund$ by ! grant "u ?is section aft] subsection 7g72 7#f7 9 subsection 7j7-- 7,a7 9 p>agraph 7#a71 by ins]t+ = grants aw>d$ prior to ! date ( enactm5t ( ! ,,support = ,pati5ts & ,communities ,reau?orization ,act ( #bjbe aft] grant p]iod "u ?is section2 & 7,b7 9 p>agraph 7#b7-- 7i7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ #b ye>s aft] submitt+ ! prelim9>y report requir$ "u p>agraph 7#a7 & ins]t+ ,septemb] #cj1 #bjbi2 & 7ii7 9 subp>agraph 7,a71 by /rik+ 7g77#c7 & ins]t+ 7g77#a77;,c72 & 7#g7 9 subsection 7k71 by /rik+ #e1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc & ins]t+ #ab1jjj1jjj = ea* ( fiscal ye>s #bjbe ?r\gh #bjbi4 7b7 ,reau?orization ( ! ,,c>e] ,act2 ,recov]y ,h\s+ ,pilot ,program 7#a7 ,9 g5]al ,section #hjga ( ! ,,support = ,pati5ts & ,communities ,act 7#db ,u4,s4,c4 #ecja note2 ,public ,law #aae-bga7 is am5d$-- 7,a7 by /rik+ ! section head+ & ins]t+ ,,c>e] ,act2 ,recov]y ,h\s+ ,pilot ,program2 7,b7 9 subsection 7a71 by /rik+ ?r\gh #bjbc & ins]t+ ?r\gh #bjbi2 7,c7 9 subsection 7b7-- 7i7 9 p>agraph 7#a71 by /rik+ n lat] ?an #fj days aft] ! date ( enactm5t ( ?is ,act & ins]t+ n lat] ?an #fj days aft] ! date ( enactm5t ( ! ,,support = ,pati5ts & ,communities ,reau?orization ,act ( #bjbe2 & 7ii7 9 p>agraph 7#b77;,b77i7-- 7,i7 9 subclause 7,i7-- 7aa7 by /rik+ = cal5d> ye>s #bjac ?r\gh #bjag2 & 7bb7 by ins]t+ = cal5d> ye>s #bjah ?r\gh #bjbb aft] rates ( unemploym5t2 7,,ii7 9 subclause 7,,ii7-- 7aa7 by /rik+ = cal5d> ye>s #bjac ?r\gh #bjag2 & 7bb7 by ins]t+ = cal5d> ye>s #bjah ?r\gh #bjbb aft] p>ticipation rates2 & 7,,iii7 by /rik+ subclause 7,,iii7 & ins]t+ ! foll[+3 7,,iii7 ,! highe/ age-adju/$ av]age rates ( drug ov]dose dea?s = cal5d> ye>s #bjah ?r\gh #bjbb bas$ on data f ! ,c5t]s = ,disease ,control & ,prev5tion1 includ+1 if necess>y1 provisional data = cal5d> ye> #bjbb4 2 & 7,d7 9 subsection 7f71 by /rik+ ,= ! #b-ye> p]iod foll[+ ! date ( enactm5t ( ?is ,act1 ! & ins]t+ ,!4 7#b7 ,con=m+ am5dm5t ,subtitle ,f ( title ,,viii ( ! ,,support = ,pati5ts & ,communities ,act 7,public ,law #aae-bga2 #acb ,/at4 #djie7 is am5d$ by /rik+ ! subtitle head+ & ins]t+ ! foll[+3 ,subtitle ,f--,,c>e] ,act2 ,recov]y ,h\s+ ,pilot ,program4 7c7 ,cl]ical am5dm5ts ,! table ( cont5ts 9 section #a7;b7 ( ! ,,support = ,pati5ts & ,communities ,act 7,public ,law #aae-bga2 #acb ,/at4 #chid7 is am5d$-- 7#a7 by /rik+ ! item relat+ to section #gahc & ins]t+ ! foll[+3 ,sec4 #gahc4 ,,c>e] ,act2 treatm5t1 recov]y1 & work=ce support grants4 2 7#b7 by /rik+ ! item relat+ to subtitle ,f ( title ,,viii & ins]t+ ! foll[+3 ,subtitle ,f--,,c>e] ,act2 ,recov]y ,h\s+ ,pilot ,program 2 & 7#c7 by /rik+ ! item relat+ to section #hjga & ins]t+ ! foll[+3 ,sec4 #hjga4 ,,c>e] ,act2 ,recov]y ,h\s+ ,pilot ,program4 4 #edf4 ,address+ economic & work=ce impacts ( ! opioid crisis ,section #hjda7;g77#a7 ( ! ,,support = ,pati5ts & ,communities ,act 7#bi ,u4,s4,c4 #cbbe;a7g77#a77 is am5d$ by /rik+ #bjbc & ins]t+ #bjbi4 ,d ,miscellane\s matt]s #eea4 ,deliv]y ( a controll$ sub/ance by a ph>macy to a prescrib+ practition] ,section #cji;,a7a7 ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbi;a7a77 is am5d$ by /rik+ p>agraph 7#b7 & ins]t+ ! foll[+3 7#b7 ! controll$ sub/ance is a drug 9 s*$ule ,,iii1 ,,iv1 or ,v to be adm9i/]$-- 7,a7 by injection or implantation = ! purpose ( ma9t5ance or detoxification treatm5t2 or 7,b7 subject to a risk evaluation & mitigation /rategy pursuant to section #eje-a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7 t includes elem5ts to assure safe use ( ! drug describ$ 9 subsection 7f77#c77;,e7 ( su* section1 includ+ a requirem5t = po/-adm9i/ration monitor+ by a heal? c>e provid]4 4 #eeb4 ,te*nical correction on controll$ sub/ances disp5s+ ,effective z if includ$ 9 ! enactm5t ( ,public ,law #aag-cbh-- 7#a7 section #abeb7;a7 ( division ,,ff ( ,public ,law #aag-cbh 7#acf ,/at4 #efha7 is am5d$1 9 ! matt] be+ ins]t$ into section #cjb7;e7 ( ! ,controll$ ,sub/ances ,act1 by /rik+ #cjc7;g7 & ins]t+ #cjc7;h72 7#b7 section #abfb ( division ,,ff ( ,public ,law #aag-cbh 7#acf ,/at4 #efha7 is am5d$-- 7,a7 9 subsection 7a7-- 7i7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ #cjc7;g7 & ins]t+ #cjc7;h72 7ii7 9 ! matt] be+ /rick5 by subsection 7a77#b71 by /rik+ 7g77#a7 & ins]t+ 7h77#a72 & 7iii7 9 ! matt] be+ ins]t$ by subsection 7a77#b71 by /rik+ 7g7 ,practition]s & ins]t+ 7h7 ,practition]s2 & 7,b7 9 subsection 7b7-- 7i7 9 ! matt] be+ /rick5 by p>agraph 7#a71 by /rik+ #cjc7;g77#a7 & ins]t+ #cjc7;h77#a72 7ii7 9 ! matt] be+ ins]t$ by p>agraph 7#a71 by /rik+ #cjc7;g7 & ins]t+ #cjc7;h72 7iii7 9 ! matt] be+ /rick5 by p>agraph 7#b77;,a71 by /rik+ #cjc7;g77#b7 & ins]t+ #cjc7;h77#b72 7iv7 9 ! matt] be+ /rick5 by p>agraph 7#c71 by /rik+ #cjc7;g77#b77;,b7 & ins]t+ #cjc7;h77#b77;,b72 7v7 9 ! matt] be+ /rick5 by p>agraph 7#e71 by /rik+ #cjc7;g7 & ins]t+ #cjc7;h72 & 7vi7 9 ! matt] be+ /rick5 by p>agraph 7#f71 by /rik+ #cjc7;g7 & ins]t+ #cjc7;h72 & 7#c7 section #abfc7;b7 ( division ,,ff ( ,public ,law #aag-cbh 7#acf ,/at4 #efhe7 is am5d$-- 7,a7 by /rik+ #cjc7;g77#b7 & ins]t+ #cjc7;h77#b72 & 7,b7 by /rik+ 7#ba ,u4,s4,c4 #hbc7;g77#b77 & ins]t+ 7#ba ,u4,s4,c4 #hbc7;h77#b774 #eec4 ,requir$ tra9+ = prescrib]s ( controll$ sub/ances 7a7 ,9 g5]al ,section #cjc ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbc7 is am5d$-- 7#a7 by r$esignat+ ! second subsection designat$ z subsection 7l7 z subsection 7m72 & 7#b7 9 subsection 7m77#a71 z s r$esignat$-- 7,a7 9 subp>agraph 7,a7-- 7i7 9 clause 7iv7-- 7,i7 9 subclause 7,i7-- 7aa7 by ins]t+ ! ,am]ican ,academy ( ,family ,physicians1 ! ,am]ican ,podiatric ,m$ical ,association1 ! ,academy ( ,g5]al ,d5ti/ry1 ! ,am]ican ,optometric ,association1 be=e or any o!r organization2 7bb7 by /rik+ or ! ,commission & ins]t+ ! ,commission2 & 7cc7 by ins]t+ 1 or ! ,c\ncil on ,podiatric ,m$ical ,education be=e ! semicolon at ! end2 & 7,,ii7 9 subclause 7,,iii71 by ins]t+ or ! ,am]ican ,academy ( ,family ,physicians aft] ,association2 & 7ii7 9 clause 7v71 9 ! matt] prec$+ subclause 7,i7-- 7,i7 by /rik+ o/eopa?ic m$ic9e1 d5tal surg]y & ins]t+ o/eopa?ic m$ic9e1 podiatric m$ic9e1 d5tal surg]y2 & 7,,ii7 by /rik+ or d5tal m$ic9e curriculum & ins]t+ or d5tal or podiatric m$ic9e curriculum2 & 7,b7 9 subp>agraph 7,b7-- 7i7 9 clause 7i7-- 7,i7 by ins]t+ ! ,am]ican ,ph>maci/s ,association1 ! ,accr$itation ,c\ncil on ,ph>macy ,education1 ! ,am]ican ,psy*iatric ,nurses ,association1 ! ,am]ican ,academy ( ,nurs+1 ! ,am]ican ,academy ( ,family ,physicians1 be=e or any o!r organization2 & 7,,ii7 by ins]t+ 1 ! ,am]ican ,academy ( ,family ,physicians1 be=e or ! ,accr$itation ,c\ncil2 & 7ii7 9 clause 7ii7-- 7,i7 by /rik+ or accr$it$ s*ool & ins]t+ 1 an accr$it$ s*ool2 & 7,,ii7 by ins]t+ 1 or an accr$it$ s*ool ( ph>macy be=e 9 ! ,unit$ ,/ates4 7b7 ,effective date ,! am5dm5t made by subsection 7a7 %all take effect z if enact$ on ,decemb] #bi1 #bjbb4 #eed4 ,ext5sion ( tempor>y ord] = f5tanyl-relat$ sub/ances ,effective z if includ$ 9 ! enactm5t ( ! ,tempor>y ,reau?orization & ,/udy ( ! ,em]g5cy ,s*$ul+ ( ,f5tanyl ,analogues ,act 7,public ,law #aaf-aad71 section #b ( su* ,act is am5d$ by /rik+ ,m>* #ca1 #bjbe & ins]t+ ,septemb] #cj1 #bjbf4 ,,vi ,p&emic & ,all-,haz>ds ,prep>$ness & ,response #fja4 ,%ort title ,?is title may be cit$ z ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,response ,act4 ,a ,/ate & local read9ess & response #faa4 ,tempor>y reassignm5t ( ,/ate & local p]sonnel dur+ a public heal? em]g5cy ,section #cai7;e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d7e77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ tribal organization or su* ,gov]nor or tribal organization's designee & ins]t+ ,tribal organization or ! designee ( ! ,gov]nor or ,tribal organization1 or ! ,/ate or ,tribal heal? (ficial2 7#b7 9 p>agraph 7#b77;,b7-- 7,a7 9 ! matt] prec$+ clause 7i71 by /rik+ tribal organization & ins]t+ ,tribal organization1 or ! ,/ate or ,tribal heal? (ficial2 & 7,b7 9 clause 7v71 by /rik+ tribal organization & ins]t+ ,tribal organization or ,/ate or ,tribal heal? (ficial2 7#c7 9 p>agraph 7#f7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a7-- 7i7 by /rik+ ,reau?orization ,act ( #bjac & ins]t+ & ,response ,act2 & 7ii7 by /rik+ appropriate committees ( ! ,congress & ins]t+ ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives2 & 7,b7 9 subp>agraph 7,a71 by ins]t+ 1 includ+ reque/s f ,/ate or ,tribal heal? (ficials be=e ! semicolon2 7#d7 9 p>agraph 7#g77;,a71 by /rik+ tribal organization & ins]t+ ,tribal organization2 & 7#e7 9 p>agraph 7#h71 by /rik+ ,m>* #ca1 #bjbe & ins]t+ ,decemb] #ca1 #bjbf4 #fab4 ,public ,heal? ,em]g5cy ,prep>$ness program ,section #cai;,c-#a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#c;a7 is am5d$-- 7#a7 9 subsection 7b77#b7-- 7,a7 9 subp>agraph 7,a77ii71 by /rik+ influ5za & ins]t+ response plann+2 & 7,b7 9 subp>agraph 7,h71 by ins]t+ 1 su* z community-bas$ organizations1 includ+ fai?-bas$ organizations1 & o!r public & private entities aft] /akehold]s2 7#b7 9 subsection 7g7-- 7,a7 9 p>agraph 7#a71 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ & ! ability ( ea* entity receiv+ an aw>d "u subsection 7a7 to respond to all-haz>ds ?reats be=e ! p]iod at ! end ( ! fir/ s5t5ce2 7,b7 9 p>agraph 7#b7-- 7i7 9 ! p>agraph head+1 by /rik+ influ5za & ins]t+ response2 & 7ii7 9 subp>agraph 7,a7-- 7,i7 by /rik+ to p&emic influ5za & ins]t+ to a pa?og5 caus+ a p&emic1 includ+ p&emic influ5za2 & 7,,ii7 by /rik+ su* p&emic influ5za & ins]t+ su* p&emic response2 7,c7 9 p>agraph 7#e7-- 7i7 9 ! p>agraph head+1 by /rik+ influ5za & ins]t+ p&emic response2 7ii7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ #bjai & ins]t+ #bjbf2 7iii7 9 subp>agraph 7,a71 by /rik+ #bjah & ins]t+ #bjbe2 & 7iv7 9 subp>agraph 7,b71 by /rik+ p&emic influ5za & ins]t+ a pa?og5 caus+ a p&emic2 & 7,d7 9 p>agraph 7#f7-- 7i7 9 subp>agraph 7,a71 9 ! matt] prec$+ clause 7i71 by /rik+ ,! am\nts describ$ 9 ?is p>agraph are ! foll[+ am\nts t are payable to an entity = activities describ$ 9 ?is section or section #cai;,c-#b & ins]t+ ,! ,secret>y %all )hold f an entity pursuant to p>agraph 7#e7 = noncompliance ) ! requirem5ts ( ?is section or section #cai;,c-#b z foll[s2 & 7ii7 9 subp>agraph 7,b71 by ins]t+ ) respect to ! requirem5ts ( ?is section or section #cai;,c-#b aft] p>agraph 7#e72 & 7#c7 9 subsection 7h77#a77;,a71 by /rik+ #fhe1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc & ins]t+ #gce1jjj1jjj = ea* ( fiscal ye>s #bjbe & #bjbf1 to rema9 available ?r\gh ,decemb] #ca1 #bjbf4 #fac4 ,hospital ,prep>$ness ,program 7a7 ,increas+ p>ticipation by ,,ems 9 ! hospital prep>$ness program 7#a7 ,9 g5]al ,section #cai;,c-#b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#c;b7 is am5d$-- 7,a7 9 subsection 7b77#a77;,a7-- 7i7 9 clause 7iii77,,iii71 by /rik+ 2 & & ins]t+ a semicolon2 & 7ii7 by /rik+ clause 7iv7 & ins]t+ ! foll[+3 7iv7 "o or m em]g5cy m$ical s]vice organizations2 & 7v7 to ! ext5t practicable1 "o or m em]g5cy managem5t organizations2 & 2 & 7,b7 9 subsection 7g77#a7-- 7i7 by /rik+ 7#a7 ,local response capabilities & ins]t+3 7#a7 ,local response capabilities 7,a7 ,program coord9ation 2 7ii7 by /rik+ ext5t practicable1 ensure & ins]t+ ! foll[+3 8ext5t practicable-- 7i7 ensure 2 7iii7 by /rik+ ! p]iod & ins]t+ 2 &2 & 7iv7 by add+ at ! end ! foll[+3 7ii7 seek to increase p>ticipation ( eligible entities describ$ 9 subsection 7b77#a77;,a7 ) l[] p>ticipation rates relative to o!r eligible entities1 su* z em]g5cy m$ical s]vices organizations & heal? c>e facilities 9 und]s]v$ areas4 4 7#b7 ,pref]5ces ,section #cai;,c-#b7;d77#a77;,a77iii7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#c;b7d77#a77;,a77iii77 is am5d$ by /rik+ subsection 7b77#a77;,a77ii7 & ins]t+ clauses 7ii7 & 7iv7 ( subsection 7b77#a77;,a74 7b7 ,improv+ m$ical read9ess & response capabilities ,section #cai;,c-#b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#c;b7 is am5d$-- 7#a7 9 subsection 7b77#b7-- 7,a7 9 subp>agraph 7,a71 by /rik+ & at ! end2 7,b7 9 subp>agraph 7,b71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,c7 by ins]t+ at ! end ! foll[+3 7,c7 designate a lead entity to adm9i/] su* aw>d & support coord9ation betwe5 entities describ$ 9 ?is subsection4 2 7#b7 9 subsection 7g77#a71 z am5d$ by subsection 7a77#a77;,b71 by add+ at ! end ! foll[+3 7,b7 ,regional op]ations ,an eligible entity %all e/abli% & ma9ta91 or lev]age an exi/+1 capability to enable coord9ation ( regional m$ical op]ations1 :i* may include sy/ems to facilitate in=mation %>+ & coord9ation1 )9 a coalition describ$ "u subsection 7b77#a77;,a7 &1 z appropriate1 among multiple coalitions t are 9 close geographic proximity to ea* o!r4 2 & 7#c7 9 subsection 7j77#a7-- 7,a7 9 subp>agraph 7,a71 by /rik+ = ea* ( fiscal ye>s #bjai ?r\gh #bjbc & ins]t+ = ea* ( fiscal ye>s #bjbe & #bjbf1 to rema9 available ?r\gh ,decemb] #ca1 #bjbf2 & 7,b7 9 subp>agraph 7,b77iii71 by /rik+ ,septemb] #cj1 #bjbc & ins]t+ ,decemb] #ca1 #bjbf4 #fad4 ,facilities & capacities ( ! ,c5t]s = ,disease ,control & ,prev5tion to combat public heal? security ?reats ,section #cai;,d7h7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#d7;h77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ #be1jjj1jjj = ea* ( fiscal ye>s #bjbb & #bjbc & ins]t+ #dj1jjj1jjj = ea* ( fiscal ye>s #bjbe & #bjbf1 to rema9 available ?r\gh ,decemb] #ca1 #bjbf2 & 7#b7 9 p>agraph 7#b71 by /rik+ #bjbb & #bjbc & ins]t+ #bjbe & #bjbf1 to rema9 available ?r\gh ,decemb] #ca1 #bjbf4 #fae4 ,pilot program to support ,/ate m$ical /ockpiles 7a7 ,9 g5]al ,section #cai;,f-#b7;i7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7i77 is am5d$-- 7#a7 9 p>agraph 7#b77;,b77i7-- 7,a7 9 subclause 7,i71 by /rik+ & #bjbd & ins]t+ ?r\gh #bjbe2 & 7,b7 9 subclause 7,,ii71 by /rik+ #bjbe & ins]t+ #bjbf2 7#b7 9 p>agraph 7#d7-- 7,a7 9 subp>agraph 7,g71 by /rik+ 2 & at ! end & ins]t+ a semicolon2 7,b7 by r$esignat+ subp>agraph 7,h7 z subp>agraph 7,i72 7,c7 by ins]t+ aft] subp>agraph 7,g7 ! foll[+3 7,h7 facilitate ! %>+ ( be/ practices among ,/ates )9 a consortia ( ,/ates 9 receipt ( fund+ relat$ to e/abli%+ & ma9ta9+ a /ockpile ( m$ical products2 & 2 & 7,d7 9 subp>agraph 7,i71 z s r$esignat$1 by /rik+ ,/ate ef=ts & ins]t+ ,/ate or regional ef=ts2 7#c7 by r$esignat+ p>agraphs 7#e7 ?r\gh 7#i7 z p>agraphs 7#f7 ?r\gh 7#aj71 respectively2 7#d7 by ins]t+ aft] p>agraph 7#d7 ! foll[+3 7#e7 ,coord9ation ,an entity 9 receipt ( an aw>d "u p>agraph 7#a71 9 c>ry+ out ! activities "u ?is subsection1 %all coord9ate ) appropriate heal? c>e entities1 heal? (ficials1 & em]g5cy managem5t (ficials )9 ! jurisdiction ( su* ,/ate or ,/ates4 2 & 7#e7 9 p>agraph 7#aj71 z s r$esignat$1 by /rik+ #c1ejj1jjj1jjj = ea* ( fiscal ye>s #bjbc & #bjbd & ins]t+ #c1cfe1jjj1jjj = fiscal ye> #bjbe1 & #c1bfe1jjj1jjj = fiscal ye> #bjbf4 7b7 ,,gao report ,section #bdji7;b7 ( ! ,,prev5t ,p&emics ,act 7,public ,law #aag-cbh7 is am5d$-- 7#a7 9 p>agraph 7#b71 by /rik+ 2 & & ins]t+ a semicolon2 7#b7 9 p>agraph 7#c71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7#c7 by add+ at ! end ! foll[+3 7#d7 ! impact ( any regional /ockpil+ approa*es c>ri$ out "u subsection 7i77#a7 ( section #cai;,f-#b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b74 4 #faf4 ,enhanc+ dome/ic wa/ewat] surveillance = pa?og5 detection 7a7 ,9 g5]al ,title ,,iii ( ! ,public ,heal? ,s]vice ,act is am5d$ by ins]t+ aft] section #cag,v 7#db ,u4,s4,c4 #bdg;b-#bd7 ! foll[+3 #cag,w4 ,wa/ewat] surveillance = pa?og5 detection 7a7 ,wa/ewat] surveillance sy/em ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion & 9 coord9ation ) o!r ,f$]al dep>tm5ts & ag5cies1 %all aw>d grants1 contracts1 or coop]ative agreem5ts to eligible entities to e/abli%1 ma9ta91 or improve activities relat$ to ! detection & monitor+ ( infecti\s diseases ?r\gh wa/ewat] = public heal? em]g5cy prep>$ness & response purposes4 7b7 ,eligible entities ,to be eligible to receive an aw>d "u ?is section1 an entity %all-- 7#a7 be a ,/ate1 ,tribal1 or local heal? dep>tm5t1 or a p>tn]%ip betwe5 su* a heal? dep>tm5t & o!r public & private entities2 & 7#b7 submit to ! ,secret>y an application at su* "t1 9 su* mann]1 & conta9+ su* in=mation z ! ,secret>y may reasonably require1 :i* %all include-- 7,a7 a description ( activities propos$ to be c>ri$ out pursuant to an aw>d "u subsection 7a72 7,b7 factors su* entity proposes to use to select wa/ewat] sampl+ sites2 7,c7 factors su* entity proposes to use to det]m9e :e!r a response to f9d+s f su* wa/ewat] sampl+ may be w>rant$1 & a plan = respond+1 z appropriate1 consi/5t ) applicable plans develop$ by su* entity pursuant to section #cai;,c-#a2 7,d7 a plan to su/a9 su* wa/ewat] surveillance activities describ$ 9 su* application foll[+ ! conclusion ( ! aw>d p]iod2 & 7,e7 any additional in=mation ! ,secret>y may require4 7c7 ,consid]ation ,9 mak+ aw>ds "u subsection 7a71 ! ,secret>y may give priority to eligible entities t h submitt$ an application t-- 7#a7 details plans to provide public access to deid5tifi$ data g5]at$ ?r\gh su* wa/ewat] surveillance activities 9 a mann] t all[s = comp>ison to su* data g5]at$ by o!r recipi5ts ( an aw>d "u subsection 7a72 & 7#b7 provides an assessm5t ( community ne$s relat$ to ongo+ infecti\s disease monitor+1 includ+ e/imates ( ! incid5ce & preval5ce ( infecti\s diseases t c be detect$ 9 wa/ewat] & availability1 at ! "t ( ! application1 ( o!r =ms ( infecti\s disease detection 9 ! jurisdiction4 7d7 ,use ( funds ,an eligible entity %all1 z appropriate1 use am\nts aw>d$ "u ?is section to-- 7#a7 e/abli% or enhance exi/+ capacity & capabilities to conduct wa/ewat] sampl+1 te/+1 & relat$ analysis2 7#b7 conduct wa/ewat] surveillance1 z appropriate1 9 areas or facilities ) increas$ risk ( infecti\s disease outbreaks & limit$ ability to utilize o!r =ms ( infecti\s disease detection1 su* z at individual facilities1 in/itutions1 & locations 9 rural areas or areas 9 :i* wa/ewat] is n treat$ ?r\gh ! relevant local utility ( ! jurisdiction2 & 7#c7 implem5t projects t use evid5ce-bas$ or innovative practices to conduct wa/ewat] surveillance activities4 7e7 ,p>tn]%ips ,9 c>ry+ out activities "u ?is section1 eligible entities %all id5tify opportunities to p>tn] ) o!r public or private entities to lev]age relevant capabilities ma9ta9$ by su* entities1 z appropriate & consi/5t ) ?is section4 7f7 ,te*nical assi/ance ,! ,secret>y1 9 consultation ) ! heads ( o!r applicable ,f$]al ag5cies & dep>tm5ts1 z appropriate1 %all provide te*nical assi/ance to recipi5ts ( aw>ds "u ?is section to facilitate ! plann+1 developm5t1 & implem5tation ( activities describ$ 9 subsection 7d74 7g7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re is au?oriz$ to be appropriat$ #bj1jjj1jjj = ea* ( fiscal ye>s #bjbe & #bjbf1 to rema9 available ?r\gh ,decemb] #ca1 #bjbf4 4 7b7 ,wa/ewat] surveillance rese>* 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 79 ?is subsection ref]r$ to z ! ,secret>y7 %all cont9ue to conduct or support rese>* on ! use ( wa/ewat] surveillance to detect & monitor em]g+ infecti\s diseases1 :i* may include-- 7,a7 rese>* to improve ! effici5cy & effectiv5ess ( wa/ewat] sample collection & analysis & increase ! s5sitivity & specificity ( wa/ewat] te/+ me?ods2 & 7,b7 implem5tation & developm5t ( evid5ce-bas$ practices to facilitate ! e/imation ( ! incid5ce & preval5ce ( infecti\s disease )9 a community4 7#b7 ,non-duplication ( ef=t ,! ,secret>y %all ensure t activities c>ri$ out "u ?is subsection d n unnecess>ily duplicate ef=ts ( o!r ag5cies & (fices )9 ! ,dep>tm5t ( ,heal? & ,human ,s]vices relat$ to wa/ewat] surveillance4 #fag4 ,reau?orization ( ,mosquito ,abatem5t = ,safety & ,heal? program ,section #cag,s ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;b-#ba7 is am5d$-- 7#a7 9 subsection 7a77#c77;,a71 by /rik+ subsection 7b77#c7 & ins]t+ subsection 7b77#d72 7#b7 9 subsection 7b7-- 7,a7 by r$esignat+ p>agraphs 7#c7 ?r\gh 7#f7 z p>agraphs 7#d7 ?r\gh 7#g71 respectively2 & 7,b7 by ins]t+ aft] p>agraph 7#b7 ! foll[+3 7#c7 ,consid]ations ,! ,secret>y may consid] ! use ( innovative & novel te*nology = mosquito prev5tion & control 9 mak+ grants "u p>agraph 7#a74 2 7#c7 by am5d+ subsection 7d7 to read z foll[s3 7d7 ,uses ( funds ,am\nts appropriat$ "u subsection 7f7 may be us$ by ! ,secret>y to provide tra9+ & te*nical assi/ance ) respect to ! plann+1 developm5t1 & op]ation ( assessm5ts & plans "u subsection 7a7 & control programs "u subsection 7b74 ,! ,secret>y may provide su* tra9+ & te*nical assi/ance directly or ?r\gh aw>ds ( grants or contracts to public & private entities4 2 & 7#d7 9 subsection 7f77#a71 by /rik+ #bjai ?r\gh #bjbc & ins]t+ #bjbe & #bjbf1 to rema9 available ?r\gh ,decemb] #ca1 #bjbf4 ,b ,f$]al plann+ & coord9ation #fba4 ,all-,haz>ds ,em]g5cy ,prep>$ness & ,response ,section #bhaa ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#aj7 is am5d$-- 7#a7 9 subsection 7b7-- 7,a7 9 p>agraph 7#c7-- 7i7 by /rik+ ,ov]see advanc$ rese>*1 developm5t1 & procurem5t & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,ov]see advanc$ rese>*1 developm5t1 procurem5t1 & repl5i%m5t 2 & 7ii7 by add+ at ! end ! foll[+3 7,b7 ,developm5t ( requirem5ts ,lead ! developm5t & approval1 &1 on a r\t9e basis1 ! review & update1 ( requirem5ts = su* c\nt]measures & products1 includ+ relat$ capabilities1 to in=m ! advanc$ rese>*1 developm5t1 procurem5t1 & repl5i%m5t decisions ( ! ,secret>y4 2 7,b7 9 p>agraph 7#d7-- 7i7 9 subp>agraph 7,f7-- 7,i7 9 ! matt] prec$+ clause 7i71 by /rik+ & 9 consultation ) ! ,secret>y ( ,homel& ,security12 & 7,,ii7 9 clause 7i71 by ins]t+ enhance aft] capabilities &2 7ii7 9 subp>agraph 7,g7-- 7,i7 9 ! matt] prec$+ clause 7i71 by ins]t+ ! ,(fice ( ,p&emic ,prep>$ness & ,response ,policy1 aft] ,vet]ans ,affairs12 7,,ii7 9 clause 7i71 by /rik+ bas$ on & ins]t+ bas$ on--2 7,,iii7 9 clause 7ii71 by /rik+ 2 & at ! end & ins]t+ a semicolon2 7,,iv7 9 clause 7iii71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,v7 by add+ at ! end ! foll[+3 7iv7 t include1 z appropriate1 p>ticipation by relevant indu/ry1 academia1 pr(essional societies1 & o!r /akehold]s4 2 7iii7 9 subp>agraph 7,h7-- 7,i7 by ins]t+ & ! ,director ( ! ,(fice ( ,p&emic ,prep>$ness & ,response ,policy aft] ,security ,affairs2 & 7,,ii7 by ins]t+ & m$ical product & supply capacity plann+ pursuant to subp>agraph 7,j71 includ+ discussion ( any relevant id5tifi$ supply *a9 vuln]abilities be=e ! p]iod at ! end2 7iv7 9 subp>agraph 7,i71 by ins]t+ ! ,director ( ! ,(fice ( ,p&emic ,prep>$ness & ,response ,policy1 aft] ,security ,affairs12 & 7v7 9 subp>agraph 7,j77i71 9 ! matt] prec$+ subclause 7,i71 by ins]t+ 7includ+ ancill>y m$ical supplies & compon5ts ( m$ical products1 su* z active ph>maceutical +r$i5ts1 key />t+ mat]ials1 m$ical device compon5ts1 te/+ kits1 reag5ts1 & o!r te/+ supplies7 aft] supply ne$s2 & 7,c7 9 p>agraph 7#g7-- 7i7 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ & ! requirem5ts develop$ pursuant to p>agraph 7#c77;,b7 aft] subsection 7d72 7ii7 by r$esignat+ subp>agraphs 7,e7 & 7,f7 z subp>agraphs 7,f7 & 7,g71 respectively2 & 7iii7 by ins]t+ aft] subp>agraph 7,d7 ! foll[+3 7,e7 include a pr(essional judgm5t ( anticipat$ budget ne$s = ea* future fiscal ye> acc\nt$ = 9 su* plan to acc\nt = ! full range ( anticipat$ m$ical c\nt]measure ne$s & life-cycle co/s to address su* priorities & requirem5ts2 2 7#b7 9 subsection 7d7-- 7,a7 by am5d+ p>agraph 7#a7 to read z foll[s3 7#a7 ,9 g5]al ,n lat] ?an ,m>* #ae1 #bjbj1 & bi5nially !reaft]1 ! ,assi/ant ,secret>y = ,prep>$ness & ,response %all develop & submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a coord9at$ /rategy = m$ical c\nt]measures to address *emical1 biological1 radiological1 & nucle> ?reats1 in=m$ by ! requirem5ts develop$ pursuant to subsection 7b77#c77;,b74 ,n lat] ?an #ahj days aft] ! submission ( su* /rategy to su* committees1 ! ,assi/ant ,secret>y = ,prep>$ness & ,response %all submit an accompany+ implem5tation plan to su* committees4 ,9 develop+ su* a /rategy & plan1 ! ,assi/ant ,secret>y = ,prep>$ness & ,response %all consult ) ! ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measures ,ent]prise e/abli%$ "u section #bhaa-a4 ,su* /rategy & plan %all be kn[n z ! ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measures ,ent]prise ,/rategy & ,implem5tation ,plan4 2 & 7,b7 9 p>agraph 7#b71 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ /rategy & be=e plan2 & 7#c7 9 subsection 7f7-- 7,a7 9 p>agraph 7#a71 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ 1 includ+ su* ag5ts t are an em]g+ infecti\s disease aft] become a p&emic2 & 7,b7 9 p>agraph 7#b77;,a71 by /rik+ #bej1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc & ins]t+ #cce1jjj1jjj = ea* ( fiscal ye>s #bjbe & #bjbf1 to rema9 available ?r\gh ,decemb] #ca1 #bjbf4 #fbb4 ,national ,heal? ,security ,/rategy ,section #bhjb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#a7 is am5d$-- 7#a7 9 subsection 7a77#c7-- 7,a7 by /rik+ ,9 #bjbb1 ! & ins]t+ ,!2 & 7,b7 by ins]t+ 1 ma9ta9+1 & su/a9+ aft] e/abli%+2 & 7#b7 9 subsection 7b7-- 7,a7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,a71 by ins]t+ t support int]ag5cy coord9ation & availability ( in=mation1 z appropriate be=e ! p]iod2 7ii7 9 subp>agraph 7,b71 by ins]t+ rapid te/+1 aft] & supplies12 7,b7 9 p>agraph 7#c7-- 7i7 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ & blood banks aft] d5tal heal? facilities2 7ii7 9 subp>agraph 7,c71 by ins]t+ & curr5t capacity ( facilities )9 su* sy/ems1 z applicable be=e ! p]iod2 & 7iii7 9 subp>agraph 7,d71 by ins]t+ & o!r m$ical products & m$ical supplies consi/5t ) ! activities c>ri$ out "u section #bhaa7;b77#d77;,j7 be=e ! p]iod2 7,c7 9 p>agraph 7#e71 by ins]t+ applicable f$]ally fund$ activities & aft] 7includ+2 7,d7 9 p>agraph 7#h7-- 7i7 9 subp>agraph 7,a71 by ins]t+ public heal? & m$ical be=e activities2 & 7ii7 9 subp>agraph 7,b71 by /rik+ famili>ity ) & ins]t+ und]/&+ (1 & coord9ation betwe512 7,e7 by r$esignat+ p>agraphs 7#i7 & 7#aj7 z p>agraphs 7#aj7 & 7#ab71 respectively2 7,f7 by ins]t+ aft] p>agraph 7#h7 ! foll[+3 7#i7 ,o!r sett+s ,support+ ,f$]al1 ,/ate1 local1 & ,tribal coord9ation & plann+ ) respect to facilities 9 :i* !re is an increas$ risk ( infecti\s disease outbreaks1 includ+ su* facilities t address ! ne$s ( at-risk individuals1 9 ! ev5t ( a public heal? em]g5cy decl>$ "u section #cai4 2 7,g7 by ins]t+ aft] subp>agraph 7#aj71 z s r$esignat$1 ! foll[+3 7#aa7 ,o!r haz>ds ,assess+ curr5t & pot5tial heal? security ?reats f natural disa/]s ) respect to public heal? & m$ical prep>$ness & response4 2 7,h7 by ins]t+ aft] p>agraph 7#ab71 z s r$esignat$1 ! foll[+3 7#ac7 ,cyb]security resili5cy ( heal? c>e sy/ems ,consi/5t ) ! requirem5ts ( section #bbah ( ! ,homel& ,security ,act ( #bjjb1 /r5g!n+ ! ability ( ,/ates1 local communities1 & ,tribal communities to prep>e =1 respond to1 & be resili5t aga9/ cyb]security vuln]abilities or cyb]security attacks t affect public heal? & heal? in=mation te*nology1 & enc\rag+ heal? c>e facilities to use recogniz$ security practices meet+ or exce$+ ! approa*es e/abli%$ "u section #dje7;d7 ( ! ,cyb]security ,act ( #bjae4 2 & 7,i7 by /rik+ tribal ea* place x appe>s & ins]t+ ,tribal4 #fbc4 ,improv+ developm5t & di/ribution ( diagno/ic te/s ,section #cai;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#b7 is am5d$ to read z foll[s3 #cai;,b4 ,improv+ developm5t & di/ribution ( diagno/ic te/s 7a7 ,diagno/ic te/+ prep>$ness plan ,! ,secret>y %all develop1 make publicly available1 n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,response ,act1 & update n less frequ5tly ?an e #c ye>s !reaft]1 a plan = ! rapid developm5t1 validation1 au?orization1 manufacture1 procurem5t1 & di/ribution ( diagno/ic te/s1 & = rapid scal+ ( te/+ capacity1 9 response to *emical1 biological1 radiological1 or nucle> ?reats1 includ+ em]g+ infecti\s diseases1 = :i* a public heal? em]g5cy is decl>$ "u section #cai1 or t has significant pot5tial to cause su* a public heal? em]g5cy4 7b7 ,purposes ,! purpose ( ! plan "u subsection 7a7 %all be to-- 7#a7 facilitate ! developm5t & utilization ( diagno/ic te/s2 7#b7 describe ! processes = ! rapid developm5t1 validation1 au?orization1 manufacture1 procurem5t1 & di/ribution ( diagno/ic te/s1 & = rapid scal+ ( te/+ capacity2 & 7#c7 facilitate coord9ation & collaboration among public & private entities to improve ! rapid developm5t & utilization ( diagno/ic te/+ dur+ a public heal? em]g5cy4 7c7 ,consid]ations ,! plan "u subsection 7a7 %all take into consid]ation-- 7#a7 dome/ic capacity1 includ+ any su* capacity e/abli%$ ?r\gh p>tn]%ips ) public & private entities pursuant to subsection 7e71 to support ! developm5t1 validation1 manufacture1 procurem5t1 & di/ribution ( te/s1 & ! rapid scal+ ( te/+ capacity2 7#b7 novel te*nologies & plat=ms t-- 7,a7 may be us$ to improve te/+ capabilities1 includ+-- 7i7 high-?r\ghput laboratory diagno/ics2 7ii7 po9t-(-c>e diagno/ics2 & 7iii7 rapid at-home diagno/ics2 7,b7 improve ! accessibility ( diagno/ic te/s2 & 7,c7 facilitate ! developm5t & manufacture ( diagno/ic te/s2 7#c7 m$ical supply ne$s relat$ to te/+1 includ+ diagno/ic te/+1 equipm5t1 supplies1 & compon5t p>ts1 & any pot5tial vuln]abilities relat$ to ! availability ( su* m$ical supplies & relat$ plann+ ne$s1 consi/5t ) section #bhaa7;b77#d77;,j72 7#d7 /rategies = ! rapid & effici5t di/ribution ( te/s locally1 regionally1 or nationwide & appropriate scal+ ( laboratory te/+ capacity2 & 7#e7 assessm5t ( su* /rategies ?r\gh drills & op]ational ex]cises c>ri$ out "u section #bhaa7;b77#d77;,g71 z appropriate4 7d7 ,coord9ation ,to in=m ! developm5t & update ( ! plan "u subsection 7a71 & 9 c>ry+ out activities to implem5t su* plan1 ! ,secret>y %all coord9ate ) indu/ry1 su* z device manufactur]s1 cl9ical & ref]5ce laboratories1 & m$ical product di/ributors1 ,/ates1 local gov]nm5tal entities1 ,indian ,tribes & ,tribal organizations1 & o!r relevant public & private entities4 7e7 ,capacity build+ ,! ,secret>y may contract ) public & private entities1 z appropriate1 to increase dome/ic capacity 9 ! rapid developm5t1 validation1 au?orization1 manufacture1 procurem5t1 & di/ribution ( diagno/ic te/s1 z appropriate1 to ,/ate1 local1 & ,tribal heal? dep>tm5ts & o!r appropriate entities = imm$iate public heal? response activities to address an infecti\s disease ) respect to :i* a public heal? em]g5cy is decl>$ "u section #cai1 or t has significant pot5tial to cause su* a public heal? em]g5cy4 4 #fbd4 ,combat+ antimicrobial resi/ance 7a7 ,9 g5]al ,section #cai;,e ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#e7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#a71 by ins]t+ & activities aft] ,f$]al programs2 7,b7 9 p>agraph 7#b7-- 7i7 by /rik+ public heal? con/itu5cies1 manufactur]s1 vet]9>y & m$ical pr(essional societies & o!rs & ins]t+ ! ,advisory ,c\ncil describ$ 9 subsection 7b7 & relevant public & private entities2 & 7ii7 by ins]t+ 1 pursuant to p>agraph 7#d71 aft] compreh5sive plan2 7,c7 by am5d+ p>agraph 7#c7 to read z foll[s3 7#c7 ,ag5da ,! task =ce describ$ 9 p>agraph 7#a7 %all consid] factors ! ,secret>y consid]s appropriate1 includ+ factors to-- 7,a7 sl[ ! em]g5ce ( resi/ant bact]ia & fungi & prev5t ! spread ( resi/ant infections2 7,b7 /r5g!n activities to combat resi/ance ) respect to zoonotic diseases2 7,c7 advance developm5t & use ( rapid & innovative capabilities1 includ+ diagno/ic te/s1 = id5tification & *>act]ization ( resi/ant bact]ia & fungi2 7,d7 accel]ate basic & appli$ rese>* & developm5t = new antibiotics1 antifungals1 & o!r relat$ !rapeutics & vacc9es2 & 7,e7 support int]national collaboration & capacities = antimicrobial-resi/ance prev5tion1 detection1 & control4 2 7,d7 by r$esignat+ p>agraph 7#d7 z p>agraph 7#e72 7,e7 by ins]t+ aft] p>agraph 7#c7 ! foll[+3 7#d7 ,action plan ,n lat] ?an ,octob] #a1 #bjbf1 & e #e ye>s !reaft]1 ! task =ce describ$ 9 p>agraph 7#a7 %all develop & submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives a plan reg>d+ ,f$]al programs & activities to combat antimicrobial resi/ance1 includ+ measurable outcomes1 z appropriate1 in=m$ by-- 7,a7 ! ag5da describ$ 9 p>agraph 7#c72 7,b7 input provid$ by ! ,advisory ,c\ncil describ$ 9 subsection 7b72 & 7,c7 input f o!r relevant /akehold]s provid$ pursuant to p>agraph 7#b74 2 7#b7 by r$esignat+ subsections 7b7 ?r\gh 7o7 z subsections 7c7 ?r\gh 7p71 respectively2 7#c7 by ins]t+ aft] subsection 7a7 ! foll[+3 7b7 ,advisory c\ncil 7#a7 ,9 g5]al ,! ,secret>y may cont9ue ! ,presid5tial ,advisory ,c\ncil on ,combat+ ,antibiotic-,resi/ant ,bact]ia1 ref]r$ to 9 ?is subsection z ! ,advisory ,c\ncil4 7#b7 ,duties ,! ,advisory ,c\ncil %all advise & provide in=mation & recomm5dations to ! ,secret>y1 act+ ?r\gh ! ,task ,=ce e/abli%$ "u subsection 7a71 reg>d+ ,f$]al programs & activities int5d$ to r$uce or combat antimicrobial-resi/ant bact]ia or fungi t may pres5t a public heal? ?reat & improve capabilities to prev5t1 diagnose1 mitigate1 or treat su* resi/ance4 ,su* advice1 in=mation1 & recomm5dations may be relat$ to improv+ ,f$]al ef=ts relat$ to factors describ$ 9 subsection 7a77#c7 & o!r topics relat$ to antimicrobial resi/ance1 z appropriate4 7#c7 ,meet+s & coord9ation 7,a7 ,meet+s ,! ,advisory ,c\ncil %all meet n less frequ5tly ?an biannually &1 to ! ext5t practicable1 9 coord9ation ) meet+s ( ! task =ce e/abli%$ "u subsection 7a74 7,b7 ,coord9ation ,! ,advisory ,c\ncil %all1 to ! greate/ ext5t practicable1 coord9ate activities c>ri$ out by ! ,c\ncil ) ! task =ce e/abli%$ "u subsection 7a74 7#d7 ,,faca ,*apt] #aj ( title #e1 ,unit$ ,/ates ,code1 %all apply to ! activities & duties ( ! ,advisory ,c\ncil4 7#e7 ,sunset 7,a7 ,9 g5]al ,! ,advisory ,c\ncil "u ?is subsection %all t]m9ate on ,decemb] #ca1 #bjbf4 7,b7 ,ext5sion ( ,advisory ,c\ncil ,n lat] ?an ,octob] #a1 #bjbf1 ! ,secret>y %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report t includes a recomm5dation on :e!r ! ,advisory ,c\ncil %\ld be ext5d$1 & id5tify+ :e!r !re are o!r committees1 c\ncils1 or task =ces t h ov]lapp+ or simil> duties to t ( ! ,advisory ,c\ncil1 & :e!r su* committees1 c\ncils1 or task =ces %\ld be comb9$1 re/ructur$1 or elim9at$1 includ+ ) respect to ! task =ce e/abli%$ "u subsection 7a74 2 & 7#d7 9 subsection 7n71 z s r$esignat$1 by /rik+ 7f7 ?r\gh 7j7 & ins]t+ 7g7 ?r\gh 7k74 7b7 ,con=m+ am5dm5t ,section #eje ( ! ,p&emic & ,all-,haz>ds ,prep>$ness & ,advanc+ ,innovation ,act ( #bjai 7#db ,u4,s4,c4 #bdg;d-#e note2 ,public ,law #aaf-bb7 is am5d$ by /rik+ subsection 7a7 & all t foll[s ?r\gh ,n lat] 9 subsection 7e7 & ins]t+ ! foll[+3 ,n lat] 4 #fbe4 ,/rategic ,national ,/ockpile & mat]ial ?reats ,section #cai;,f-#b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#b7-- 7i7 9 subp>agraph 7,a71 by ins]t+ ,su* review %all include a description ( h[ ! ,secret>y manages & mitigates risks associat$ ) gaps betwe5 curr5t inv5tory levels & /ockpil+ goals1 prioritizes su* risks1 & tracks progress t[>d mitigation ( su* risks4 aft] ! fir/ s5t5ce2 & 7ii7 9 subp>agraph 7,b77i71 by am5d+ subclause 7,,iv7 to read z foll[s3 7,,iv7 ! em]g5cy heal? security ?reat or ?reats su* c\nt]measure procurem5t is int5d$ to address1 includ+-- 7aa7 :e!r su* procurem5t is consi/5t ) meet+ em]g5cy heal? security ne$s associat$ ) su* ?reat or ?reats2 & 7bb7 9 ! case ( a c\nt]measure t addresses a biological ag5t1 :e!r su* ag5t has an increas$ likelihood to become resi/ant to1 m resi/ant to1 or evade1 su* c\nt]measure relative to o!r available m$ical c\nt]measures2 2 7,b7 9 p>agraph 7#c7-- 7i7 9 subp>agraph 7,b71 by /rik+ are foll[$1 regul>ly review$1 & updat$ ) respect to su* /ockpile & ins]t+ ) respect to su* /ockpile are foll[$1 regul>ly review$1 & updat$ to reflect be/ practices2 7ii7 9 subp>agraph 7,i71 by ins]t+ 1 ?r\gh a /&>d op]at+ proc$ure1 aft] ensure2 7iii7 by r$esignat+ subp>agraphs 7,h7 ?r\gh 7,k7 z subp>agraphs 7,i7 ?r\gh 7,l71 respectively2 7iv7 by ins]t+ aft] subp>agraph 7,g7 ! foll[+3 7,h7 utilize tools to enable ! timely & accurate track+ ( ! cont5ts ( ! /ockpile ?r\gh\t ! deploym5t ( su* cont5ts1 includ+ track+ ( ! location & geographic di/ribution & utilization ( su* cont5ts2 2 7v7 9 subp>agraph 7,k71 z s r$esignat$1 by /rik+ 2 & at ! end & ins]t+ a semicolon2 7vi7 9 subp>agraph 7,l71 z s r$esignat$1 by /rik+ ! p]iod & ins]t+ 2 &2 & 7vii7 by add+ at ! end ! foll[+3 7,m7 communicate to relevant v5dors reg>d+ modifications1 r5ewals1 ext5sions1 or t]m9ations ( contracts1 or ! int5t to ex]cise options = su* contracts1 )9 #cj days1 z practicable1 ( su* det]m9ation1 includ+ ?r\gh ! developm5t ( a contract notification process4 2 7,c7 9 p>agraph 7#e77;,b71 9 ! matt] prec$+ clause 7i71 by ins]t+ 1 :i* may accompany ! review requir$ "u p>agraph 7#b71 aft] ,repres5tatives a report2 & 7,d7 9 p>agraph 7#f77;,a7-- 7i7 by r$esignat+ clauses 7viii7 ?r\gh 7x7 z clauses 7ix7 ?r\gh 7xi71 respectively2 & 7ii7 by ins]t+ aft] clause 7vii7 ! foll[+3 7viii7 ) respect to any *ange 9 ! ,f$]al organizational managem5t ( ! /ockpile1 an assessm5t & comp>ison ( any diff]5ces 9 ! processes & op]ations result+ f su* *ange1 includ+-- 7,i7 plann+ = pot5tial c\nt]measure deploym5t1 di/ribution1 or disp5s+ capabilities2 7,,ii7 organizational /ructure2 7,,iii7 communication ) relevant /akehold]s relat$ to procurem5t decisions2 7,,iv7 processes relat$ to procurem5t1 deploym5t1 & use ( /ockpil$ c\nt]measures2 7,v7 communication & coord9ation ) ! ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measures ,ent]prise & o!r relat$ ,f$]al entities2 7,,vi7 inv5tory managem5t2 & 7,,vii7 availability & use ( res\rces = su* activities2 2 & 7#b7 9 subsection 7c77#b77;,c71 by /rik+ promptly & ins]t+ 1 n lat] ?an #fj days aft] ea* su* det]m9ation12 7#c7 9 subsection 7f77#a71 by /rik+ #faj1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjba1 & #gej1jjj1jjj = ea* ( fiscal ye>s #bjbb & #bjbc & ins]t+ #a1ajj1jjj1jjj = fiscal ye> #bjbe1 & #a1baj1jjj1jjj = fiscal ye> #bjbf2 & 7#d7 9 subsection 7g77#a71 by /rik+ #bjai ?r\gh #bjbh & ins]t+ #bjbe ?r\gh #bjcd4 #fbf4 ,m$ical c\nt]measures = viral ?reats ) p&emic pot5tial ,section #cai,l ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7 is am5d$-- 7#a7 9 subsection 7c7-- 7,a7 9 p>agraph 7#d7-- 7i7 9 subp>agraph 7,d7-- 7,i7 9 clause 7ii71 by /rik+ 2 & & ins]t+ a semicolon2 & 7,,ii7 by r$esignat+ clause 7iii7 z clause 7iv72 & 7,,iii7 by ins]t+ aft] clause 7ii7 ! foll[+3 7iii7 rese>* & developm5t ( m$ical c\nt]measures = priority virus families t h significant pot5tial to cause a p&emic1 includ+ su* c\nt]measures t take ei!r pa?og5-specific or pa?og5-agno/ic approa*es1 & plat=m te*nologies to improve ! developm5t & manufacture ( su* m$ical c\nt]measures2 & 2 & 7ii7 9 subp>agraph 7,f77ii71 by ins]t+ or priority virus families & o!r viral pa?og5s t pose a ?reat due to _! significant pot5tial to cause a p&emic1 aft] p&emic influ5za12 & 7,b7 9 p>agraph 7#e71 by add+ at ! end ! foll[+3 7,i7 ,notification ,9 aw>d+ contracts1 grants1 coop]ative agreem5ts1 or o!r transactions "u ?is section1 ! ,secret>y %all communicate to relevant v5dors reg>d+ modifications1 r5ewals1 ext5sions1 or t]m9ations ( contracts1 includ+ ?r\gh ! developm5t ( a contract notification process1 )9 #cj days ( su* det]m9ation1 z practicable4 2 7#b7 9 subsection 7d77#b71 by /rik+ #faa1gjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc & ins]t+ #iej1jjj1jjj = ea* ( fiscal ye>s #bjbe & #bjbf2 & 7#c7 9 subsection 7e77#a71 by am5d+ subp>agraph 7,d7 to read z foll[s3 7,d7 ,sunset ,?is p>agraph %all cease to h =ce or effect aft] ,decemb] #ca1 #bjbf4 4 #fbg4 ,public ,heal? ,em]g5cy ,m$ical ,c\nt]measures ,ent]prise ,section #bhaa-a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;a7 is am5d$-- 7#a7 9 subsection 7b7-- 7,a7 by r$esignat+ p>agraph 7#aa7 z p>agraph 7#ac72 7,b7 by ins]t+ aft] p>agraph 7#aj7 ! foll[+3 7#aa7 ,! ,director ( ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority4 7#ab7 ,! ,director ( ! ,/rategic ,national ,/ockpile4 2 & 7,c7 9 p>agraph 7#ac71 z s r$esignat$1 by /rik+ ! ,director ( ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority1 ! ,director ( ! ,/rategic ,national ,/ockpile1 ! ,director ( ! ,national ,in/itute ( ,all]gy & ,infecti\s ,diseases1 & ins]t+ ! ,director ( ! ,national ,in/itute ( ,all]gy & ,infecti\s ,diseases2 & 7#b7 9 subsection 7c7-- 7,a7 9 p>agraph 7#a7-- 7i7 by r$esignat+ subp>agraph 7,d7 z subp>agraph 7,e72 & 7ii7 by ins]t+ aft] subp>agraph 7,c7 ! foll[+3 7,d7 ,assi/ ! ,secret>y 9 develop+ /rategies = appropriate & evid5ce-bas$ allocation & di/ribution ( c\nt]measures to jurisdictions1 9 a mann] t supports ! availability & use ( su* c\nt]measures1 = public heal? & m$ical prep>$ness & response ne$s4 2 7,b7 9 p>agraph 7#b71 by ins]t+ relevant /akehold]s1 includ+ indu/ry1 aft] consid] input f2 & 7,c7 by add+ at ! end ! foll[+3 7#c7 ,in=mation %>+ ,! ,secret>y %all1 z appropriate & 9 a mann] t does n compromise national security1 communicate & %>e in=mation relat$ to recomm5dations made & /rategies develop$ "u p>agraph 7#a7 ) relevant /akehold]s1 includ+ indu/ry & ,/ate1 local1 & ,tribal public heal? dep>tm5ts4 4 #fbh4 ,fell[%ip & tra9+ programs ,section #cag;,g ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;b-#h7 is am5d$-- 7#a7 by /rik+ ,! ,secret>y1 & ins]t+ ! foll[+3 7a7 ,9 g5]al ,! ,secret>y1 2 & 7#b7 by add+ at ! end ! foll[+3 7b7 ,noncompetitive conv]sion 7#a7 ,9 g5]al ,! ,secret>y may noncompetitively conv]t an individual :o has complet$ an epidemiology1 surveillance1 or laboratory fell[%ip or tra9+ program "u subsection 7a7 to a c>e]-conditional appo9tm5t )\t reg>d to ! provisions ( sub*apt] ,i ( *apt] #cc ( title #e1 ,unit$ ,/ates ,code1 provid$ t su* individual meets qualification requirem5ts = ! appo9tm5t4 4 #fbi4 ,regional bioconta9m5t rese>* laboratories 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all make aw>ds to e/abli% or ma9ta91 z applicable1 n few] ?an #ab regional bioconta9m5t laboratories1 = purposes (-- 7#a7 conduct+ biom$ical rese>* to support public heal? & m$ical prep>$ness =1 & rapid response to1 biological ag5ts1 includ+ em]g+ infecti\s diseases2 7#b7 ensur+ ! availability ( surge capacity = purposes ( respond+ to su* biological ag5ts2 7#c7 support+ in=mation %>+ betwe51 & ! dissem9ation ( f9d+s to1 rese>*]s & o!r relevant individuals to facilitate collaboration betwe5 indu/ry & academia2 & 7#d7 provid+1 z appropriate & applicable1 te*nical assi/ance & tra9+ to rese>*]s & o!r relevant individuals to support ! biom$ical rese>* work=ce 9 improv+ ! managem5t & mitigation ( safety & security risks 9 ! conduct ( rese>* involv+ su* biological ag5ts4 7b7 ,requirem5ts ,z a condition ( receiv+ a grant "u ?is section1 a regional bioconta9m5t laboratory %all agree to su* ov]sight activities z ! ,secret>y det]m9es appropriate1 includ+ p]iodic meet+s ) relevant (ficials ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 facility inspections1 & o!r activities z necess>y & appropriate to ensure compliance ) ! t]ms & conditions ( su* aw>d4 7c7 ,work+ gr\p ,! ,secret>y %all e/abli% a ,work+ ,gr\p1 consi/+ ( a repres5tative f ea* entity 9 receipt ( an aw>d "u subsection 7a74 ,! ,work+ ,gr\p %all make recomm5dations to ! ,secret>y 9 adm9i/]+ aw>ds "u ?is section1 = purposes (-- 7#a7 improv+ ! quality & consi/5cy ( applicable proc$ures & practices )9 laboratories fund$ pursuant to subsection 7a72 & 7#b7 ensur+ coord9ation1 z appropriate1 ( f$]ally fund$ activities c>ri$ out at su* laboratories4 7d7 ,def9ition ,9 ?is section1 ! t]m regional bioconta9m5t laboratory means a ,biosafety or ,animal ,biosafety ,level-#c & ,level-#b facility locat$ at an in/itution 9 ! ,unit$ ,/ates t is designat$ by ! ,secret>y to c>ry out ! activities describ$ 9 subsection 7a74 7e7 ,au?orization ( appropriations ,to c>ry out ?is section1 !re are au?oriz$ to be appropriat$ #eb1jjj1jjj = ea* ( fiscal ye>s #bjbe & #bjbf1 to rema9 available ?r\gh ,decemb] #ca1 #bjbf4 7f7 ,adm9i/rative exp5ses ,( ! am\nt available to c>ry out ?is section = a fiscal ye>1 ! ,secret>y may use n m ?an #e p]c5t = ! adm9i/rative exp5ses ( c>ry+ out ?is section1 includ+ exp5ses relat$ to c>ry+ out subsection 7c74 7g7 ,report to ,congress ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 & biannually !reaft]1 ! ,secret>y1 9 consultation ) ! heads ( applicable ,f$]al dep>tm5ts & ag5cies %all report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives on-- 7#a7 ! activities & accompli%m5ts ( ! regional bioconta9m5t laboratories2 7#b7 any publi%$ or dissem9at$ rese>* f9d+s bas$ on rese>* conduct$ 9 su* laboratories 9 ! applicable ye>2 7#c7 ov]sight activities c>ri$ out by ! ,secret>y pursuant to subsection 7b72 7#d7 activities und]tak5 by ! ,secret>y to take into consid]ation ! capacity & capabilities ( ! network ( regional bioconta9m5t laboratories 9 activities to prep>e = & respond to biological ag5ts1 :i* may include lev]ag+ su* capacity & capabilities to support ! ,laboratory ,response ,network1 z applicable & appropriate2 7#e7 plans = ! ma9t5ance & su/a9m5t ( f$]ally fund$ activities conduct$ at ! regional bioconta9m5t laboratories1 consi/5t ) ! /rategy requir$ "u section #bcab ( ! ,,prev5t ,p&emics ,act 7,public ,law #aag-cbh72 & 7#f7 activities und]tak5 by ! ,secret>y to coord9ate ) ! heads ( o!r relevant ,f$]al dep>tm5ts & ag5cies to ensure t "w c>ri$ out by ea* su* facility on behalf ( ! ,secret>y & su* o!r relevant heads is prioritiz$1 is complem5t>y to ! "w c>ri$ out by o!r su* facilities & o!r relevant f$]ally fund$ activities1 & avoids unnecess>y duplication4 #fbi;,a4 ,limitation relat$ to c\ntries ( conc]n conduct+ c]ta9 rese>* ,section #bcae7;c7 ( ! ,,prev5t ,p&emics ,act 7#db ,u4,s4,c4 #ffbg7 is am5d$ to read z foll[s3 7c7 ,limitations on c\ntries ( conc]n conduct+ c]ta9 rese>* 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is subsection z ! ,secret>y7 %all n fund rese>* t may reasonably be anticipat$ to involve ! creation1 transf]1 & use ( enhanc$ pa?og5s ( p&emic pot5tial or biological ag5ts or tox9s li/$ pursuant to section #cea;,a7a77#a7 ( ! ,public ,heal? ,s]vice ,act if su* rese>* is conduct$ by a =eign entity at a facility locat$ 9 a c\ntry t is det]m9$ to be a c\ntry ( conc]n z def9$ 9 p>agraph 7#b74 7#b7 ,c\ntries ( conc]n 7,a7 ,def9ition ,= purposes ( ?is subsection1 a c\ntry ( conc]n means ! ,p's ,republic ( ,*9a1 ! ,democratic ,p's ,republic ( ,korea1 ! ,russian ,f$]ation1 ! ,islamic ,republic ( ,iran1 & any o!r c\ntry z det]m9$ pursuant to subp>agraph 7,b74 7,b7 ,additional c\ntries ,! ,director ( ,national ,intellig5ce 7ref]r$ to 9 ?is subsection z ! ,director7 %all1 9 consultation ) ! ,secret>y1 add additional c\ntries ( conc]n = purposes ( p>agraph 7#a71 only if-- 7i7 ! ,director det]m9es t evid5ce exi/s t a c\ntry has malici\s int5t relat$ to ! creation1 enhancem5t1 transf]1 or use ( pa?og5s ( p&emic pot5tial or biological ag5ts or tox9s li/$ pursuant to su* section #cea;,a7a77#a72 & 7ii7 9 a mann] t does n compromise national security1 ! ,director provides su* evid5ce 9 a report submitt$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 7,c7 ,limitation ,p>agraph 7#a7 %all n take effect ) respect to a c\ntry ( conc]n id5tifi$ "u subp>agraph 7,b7 until ! date t is #ae days aft] ! date on :i* ! ,director submits ! report describ$ 9 subp>agraph 7,b77ii74 7#c7 ,cl>ification 7,a7 ,9 g5]al ,! requirem5t ( p>agraph 7#a7 may be waiv$ by ! ,presid5t = ! duration ( ! initial response to an outbreak ( a novel em]g+ infecti\s disease if ! ,presid5t det]m9es t su* requirem5t imp$es ! ability ( ! ,f$]al ,gov]nm5t to imm$iately respond to su* outbreak4 7,b7 ,notification ,! ,presid5t %all notify su* committees ( ,congress n lat] ?an #dh h\rs aft] ex]cis+ ! waiv] "u subp>agraph 7,a71 & %all provide updates to su* committees relat$ to ! use ( su* waiv] e #ae days !reaft]4 7#d7 ,sunset ,! limitation "u ?is subsection %all expire on ,decemb] #ca1 #bjbf4 4 ,c ,address+ ! ne$s ( all individuals #fca4 ,improv+ access to c]ta9 programs 7a7 ,proc$ures relat$ to ! transition ( c]ta9 claims 7#a7 ,proc$ures = correct+ submissions 7,a7 ,reque/s initially submitt$ "u section #cai;,f-#d 7i7 ,9 g5]al ,9 ! case ( a reque/ = comp5sation submitt$ "u section #cai;,f-#d ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;e7 = an injury or dea? relat$ to a m$ical product = active immunization to prev5t coronavirus disease #bjai t ! ,secret>y det]m9es to be ineligible pursuant to subsection 7b77#d77;,b7 ( su* section #cai;,f-#d1 ! ,secret>y %all1 n lat] ?an #cj days aft] su* det]m9ation1 notify ! individual submitt+ ! reque/ ( su* det]m9ation4 7ii7 ,submission ( petition ,an individual :o receives a notification describ$ 9 clause 7i7 %all be eligible to submit a petition to ! ,unit$ ,/ates ,c\rt ( ,f$]al ,claims "u section #baaa ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;aa-#aa7 ) respect to ! same m$ical product adm9i/ration claim$ 9 ! reque/ submitt$ "u section #cai;,f-#d ( su* ,act 7#db ,u4,s4,c4 #bdg;d-#f;e71 provid$ su* petition is submitt$ n lat] ?an ! lat] (-- 7,i7 #a ye> aft] receiv+ su* notification "u clause 7i72 or 7,,ii7 ! la/ date on :i* ! individual o!rwise w\ld be eligible to submit a petition relat+ to su* injury1 z specifi$ 9 section #baaf ( su* ,act 7#db ,u4,s4,c4 #cjj;aa-#af74 7iii7 ,eligibility ,to be eligible to submit a petition 9 accordance ) clause 7ii71 ! petition] %all h submitt$ ! reque/ t 0 det]m9$ to be ineligible z describ$ 9 clause 7i7 n lat] ?an ! applicable deadl9e = fil+ a petition "u su* section #baaf4 7,b7 ,reque/s initially submitt$ "u section #baaa 7i7 ,9 g5]al ,if a special ma/] det]m9es t-- 7,i7 a petition submitt$ "u section #baaa ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;aa-#aa7 relat$ to a m$ical product = active immunization to prev5t coronavirus disease #bjai t is ineligible = ! program "u subtitle #b ( title ,,xxi ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;aa-#aj et seq47 because x relates to a m$ical product adm9i/]$ at a "t :5 ! m$ical product 0 n includ$ 9 ! table "u section #baad ( su* ,act 7#db ,u4,s4,c4 #cjj;aa-#ad72 & 7,,ii7 ! m$ical product 0 adm9i/]$ :5 x 0 a cov]$ c\nt]measure subject to a decl>ation "u section #cai;,f-#c7;b7 ( su* ,act 7#db ,u4,s4,c4 #bdg;d-#f;d7b771 ! special ma/] %all1 n lat] ?an #cj days aft] su* det]m9ation1 notify ! petition] ( su* det]m9ation4 7ii7 ,submission ( reque/ ,an individual :o receives a notification describ$ 9 clause 7i7 %all be eligible to submit a reque/ = comp5sation "u section #cai;,f-#d7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;e7b77 ) respect to ! same m$ical product adm9i/ration claim$ 9 ! petition submitt$ "u section #baaa ( su* ,act 7#db ,u4,s4,c4 #cjj;aa-#aa7-- 7,i7 n lat] ?an #a ye> aft] receiv+ su* notification2 or 7,,ii7 9 ! case t ! notification is issu$ aft] judicial review ( ! petition "u subsection 7e7 or 7f7 ( section #baab ( su* ,act 7#db ,u4,s4,c4 #cjj;aa-#ab71 n lat] ?an #a ye> aft] ! judgm5t ( ! ,unit$ ,/ates ,c\rt ( ,f$]al ,claims or ! m&ate is issu$ by ! ,unit$ ,/ates ,c\rt ( ,appeals = ! ,f$]al ,circuit pursuant to su* subsection 7e7 or 7f74 7iii7 ,eligibility ,to be eligible to submit a reque/ = comp5sation 9 accordance ) clause 7ii71 ! individual submitt+ ! reque/ %all h submitt$ ! petition "u section #baaa ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;aa-#aa7 t 0 det]m9$ to be ineligible n lat] ?an #a ye> aft] ! date ( adm9i/ration ( ! m$ical product4 7#b7 ,*anges to c]ta9 programs 7,a7 ,section #cai;,f-#d ,section #cai;,f-#d ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;e7 is am5d$-- 7i7 9 subsection 7b77#d7-- 7,i7 by /rik+ ,except z provid$ & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,except z provid$ 2 & 7,,ii7 by add+ at ! end ! foll[+3 7,b7 ,exclusion ( injuries eligible = petition "u title ,,xxi ,not)/&+ any o!r provision ( ?is section1 no individual may be eligible = comp5sation "u ?is section ) respect to a vacc9e t1 at ! "t x 0 adm9i/]$1 0 includ$ 9 ! ,vacc9e ,injury ,table "u section #baad4 2 & 7ii7 9 subsection 7d77#c7-- 7,i7 by /rik+ ,?is section & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,?is section 2 & 7,,ii7 by add+ at ! end ! foll[+3 7,b7 ,exhau/ion ( rem$ies ,a cov]$ individual %all n be consid]$ to h exhau/$ rem$ies z describ$ 9 p>agraph 7#a71 nor be eligible to seek rem$y "u section #cai;,f-#c7;d71 unless su* individual has provid$ to ! ,secret>y all support+ docum5tation necess>y to facilitate ! det]m9ations requir$ "u subsection 7b77#d74 4 7,b7 ,title ,,xxi ,title ,,xxi ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;aa-#a et seq47 is am5d$-- 7i7 9 section #baaa7;a77#b77;,a7 7#db ,u4,s4,c4 #cjj;aa-#aa7;a77#b77;,a771 9 ! matt] prec$+ clause 7i71 by ins]t+ conta9+ ! in=mation requir$ "u subsection 7c7 aft] unless a petition2 7ii7 9 section #baab7;d7 7#db ,u4,s4,c4 #cjj;aa-#ab7;d77-- 7,i7 by add+ at ! end ( p>agraph 7#a7 ! foll[+3 ,su* designation %all n occur until ! petition] has fil$ all mat]ials requir$ "u section #baaa7;c742 & 7,,ii7 9 p>agraph 7#c77;,a77ii71 by /rik+ ! petition 0 fil$ & ins]t+ on :i* ! *ief special ma/] makes ! designation pursuant to p>agraph 7#a72 7iii7 9 section #baad7;e7 7#db ,u4,s4,c4 #cjj;aa-#ad7;e771 by add+ at ! end ! foll[+3 7#d7 ,lic5sure requirem5t ,not)/&+ p>agraphs 7#b7 & 7#c71 ! ,secret>y may n revise ! ,vacc9e ,injury ,table to include a vacc9e = :i* ! ,c5t]s = ,disease ,control & ,prev5tion has issu$ a recomm5dation = r\t9e use 9 *ildr5 or pregnant wom5 until at lea/ "o application = su* vacc9e has be5 approv$ "u section #cea4 ,^u su* revision ( ! ,vacc9e ,injury ,table1 all vacc9es 9 a vacc9e category on ! ,vacc9e ,injury ,table1 includ+ vacc9es au?oriz$ "u em]g5cy use pursuant to section #efd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 %all be consid]$ includ$ 9 ! ,vacc9e ,injury ,table4 2 & 7iv7 9 section #baaf 7#db ,u4,s4,c4 #cjj;aa-#af71 by add+ at ! end ! foll[+3 7d7 ,cl>ification ,not)/&+ subsections 7a7 & 7b71 an injury or dea? relat$ to a vacc9e adm9i/]$ at a "t :5 ! vacc9e 0 a cov]$ c\nt]measure subject to a decl>ation "u section #cai;,f-#c7;b7 %all n be eligible = comp5sation "u ! ,program4 4 7b7 ,accel]at+ injury comp5sation program adm9i/ration & ensur+ program integrity 7#a7 ,petitions = comp5sation ,section #baaa7;a77#b77;,a77i7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;aa-#aa7;a77#b77;,a77i77 is am5d$-- 7,a7 9 subclause 7,i71 by /rik+ 1 & & ins]t+ a semicolon2 7,b7 9 subclause 7,,ii7-- 7i7 by mov+ ! m>g9 #b ems to ! "r2 & 7ii7 by /rik+ 1 or & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+3 7,,iii7 ! judgm5t describ$ 9 subclause 7,i7 does n result f a petition]'s motion to dismiss ! case2 or 4 7#b7 ,det]m9ation ( good fai? ,section #baae7;e77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;aa-#ae7;e77#a77 is am5d$ by add+ at ! end ! foll[+3 ,:5 mak+ a det]m9ation ( good fai? "u ?is p>agraph1 ! special ma/] or c\rt may consid] :e!r ! petition] demon/rat$ an int5tion to obta9 comp5sation on su* petition & 0 n m]ely seek+ to satisfy ! exhau/ion requirem5t "u section #baba7;b744 7c7 ,ext5sion ( deadl9es ,to submit reque/s = comp5sation = c]ta9 injuries 7#a7 ,9 g5]al ,) respect to claims fil$ "u section #cai;,f-#d ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;e7 alleg+ a cov]$ injury caus$ by ! adm9i/ration or use ( a cov]$ c\nt]measure pursuant to a decl>ation "u section #cai;,f-#c7;b7 ( su* ,act 7#db ,u4,s4,c4 #bdg;d-#f;d7b77 relat+ to coronavirus disease #bjai1 ! foll[+ %all apply3 7,a7 ,not)/&+ ! fil+ deadl9e applicable "u su* section #cai;,f-#d1 ! claim %all be fil$ )9 #c ye>s ( ! adm9i/ration or use ( ! cov]$ c\nt]measure1 or #a ye> aft] ! date ( enactm5t ( ?is ,act1 :i*ev] is lat]1 &1 if a claim fil$ "u su* section #cai;,f-#d ) respect to su* adm9i/ration or use 0 fil$ be=e ! date ( enactm5t ( ?is ,act & d5i$ on ! basis ( hav+ n be5 fil$ )9 ! "t p]iod requir$ "u subsection 7b77#d7 ( su* section #cai;,f-#d1 su* claim may be refil$ pursuant to ?is subp>agraph4 7,b7 ,) respect to a claim relat+ to ! adm9i/ration ( a m$ical product = active immunization to prev5t coronavirus disease #bjai su* a claim may be fil$ "u ! su* section #cai;,f-#d only if ! adm9i/ration ( su* vacc9e occurr$ prior to ! addition ( ! vacc9e to ! ,vacc9e ,injury ,table "u section #baad ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;aa-#ad74 #fcb4 ,support+ at-risk individuals dur+ em]g5cy responses 7a7 ,te*nical assi/ance = at-,risk individuals & disa/]s 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 may provide appropriate te*nical assi/ance to ,/ates1 localities1 ,tribes1 & o!r applicable entities relat$ to address+ ! unique ne$s & consid]ations ( at-risk individuals1 z def9$ 9 section #bhjb7;b77#d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#a7;b77#d771 9 ! ev5t ( a public heal? em]g5cy decl>$ by ! ,secret>y pursuant to section #cai ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d74 7#b7 ,te*nical assi/ance ,! te*nical assi/ance describ$ 9 p>agraph 7#a7 %all include-- 7,a7 develop+1 id5tify+1 evaluat+1 & dissem9at+ evid5ce-bas$ or evid5ce-in=m$ /rategies to improve heal? & address o!r ne>-t]m or long-t]m outcomes = at-risk individuals relat$ to public heal? em]g5cies1 includ+ by address+ su* unique ne$s & consid]ations 9 c>ry+ out public heal? & m$ical activities to prep>e =1 respond to1 & recov] f1 su* public heal? em]g5cies2 & 7,b7 assi/+ applicable entities1 ?r\gh contracts or coop]ative agreem5ts1 z appropriate1 9 ! implem5tation ( su* evid5ce-bas$ /rategies4 7#c7 ,consultation ,9 c>ry+ out activities "u p>agraph 7#b71 ! ,secret>y %all take into consid]ation relevant f9d+s & recomm5dations (1 &1 z appropriate1 consult )1 ! ,national ,advisory ,committee on ,individuals ) ,disabilities & ,disa/]s e/abli%$ "u section #bhaa;,c ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;d71 ! ,national ,advisory ,committee on ,*ildr5 & ,disa/]s "u section #bhaa;,a ( su* ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;b71 & ! ,national ,advisory ,committee on ,s5iors & ,disa/]s "u section #bhaa;,b ( su* ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;c74 7b7 ,crisis /&>ds ( c>e ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y1 act+ ?r\gh ! ,director ( ! ,(fice = ,civil ,rights ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 %all issue guidance to ,/ates & localities on ! developm5t or modification ( ,/ate & local crisis /&>ds ( c>e = use dur+ ! response to a public heal? em]g5cy decl>$ by ! ,gov]nor ( a ,/ate or by ! ,secret>y "u section #cai ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d71 or a major disa/] or em]g5cy decl>$ by ! ,presid5t "u section #dja or #eja1 respectively1 ( ! ,rob]t ,t4 ,/af=d ,disa/] ,relief & ,em]g5cy ,assi/ance ,act 7#db ,u4,s4,c4 #eagj1 #eaia7 to ensure t su* /&>ds ( c>e are consi/5t ) ! nondiscrim9ation requirem5ts ( section #ejd ( ! ,rehabilitation ,act ( #aigc 7#bi ,u4,s4,c4 #gid71 title ,,ii ( ! ,am]icans ) ,disabilities ,act ( #aiij 7#db ,u4,s4,c4 #abaca et seq471 & ! ,age ,discrim9ation ,act ( #aige 7#db ,u4,s4,c4 #faja et seq474 #fcc4 ,national advisory committees 7a7 ,national ,advisory ,committee on ,*ildr5 & ,disa/]s ,subsection 7g7 ( section #bhaa;,a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;b7 is am5d$ to read z foll[s3 7g7 ,sunset 7#a7 ,9 g5]al ,! ,advisory ,committee %all t]m9ate on ,decemb] #ca1 #bjbf4 7#b7 ,ext5sion ( ,advisory ,committee ,n lat] ?an ,octob] #a1 #bjbe1 ! ,secret>y %all submit to ,congress a recomm5dation on :e!r ! ,advisory ,committee %\ld be ext5d$ beyond ! date describ$ 9 p>agraph 7#a74 4 7b7 ,national advisory committee on s5iors & disa/]s ,section #bhaa;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;c7 is am5d$-- 7#a7 9 subsection 7d7-- 7,a7 9 p>agraph 7#a7-- 7i7 by ins]t+ & dep>tm5ts aft] ag5cies2 & 7ii7 by /rik+ #ag memb]s & ins]t+ #be memb]s2 & 7,b7 9 p>agraph 7#b7-- 7i7 by /rik+ subp>agraphs 7,j7 & 7,k72 7ii7 by r$esignat+ subp>agraphs 7,a7 ?r\gh 7,i7 & 7,l7 z clauses 7i7 ?r\gh 7x71 respectively1 & adju/+ ! m>g9s accord+ly2 7iii7 by ins]t+ be=e clause 7i71 z s r$esignat$1 ! foll[+3 7,b7 ,f$]al memb]s ,! ,f$]al memb]s %all include ! foll[+3 2 & 7iv7 by ins]t+ be=e subp>agraph 7,b71 z s designat$1 ! foll[+3 7,a7 ,non-,f$]al memb]s ,! ,secret>y 9 consultation ) su* o!r heads ( ag5cies & dep>tm5ts z may be appropriate1 %all appo9t to ! ,advisory ,committee "u p>agraph 7#a7 at lea/ #ac individuals1 includ+ ! foll[+3 7i7 ,at lea/ #c non-,f$]al heal? c>e provid]s ) exp]tise 9 g]iatric m$ical disa/] plann+1 prep>$ness1 response1 or recov]y4 7ii7 ,at lea/ #c repres5tatives ( ,/ate1 local1 t]ritorial1 or ,tribal ag5cies ) exp]tise 9 g]iatric disa/] plann+1 prep>$ness1 response1 or recov]y4 7iii7 ,at lea/ #b non-,f$]al pr(essionals ) tra9+ 9 g]ontology1 su* z social work]s1 sci5ti/s1 human s]vices speciali/s1 or o!r non-m$ical pr(essionals1 ) exp]i5ce 9 disa/] plann+1 prep>$ness1 response1 or recov]y among o!r adults4 2 & 7#b7 by am5d+ subsection 7g7 to read z foll[s3 7g7 ,sunset ,! ,advisory ,committee %all t]m9ate on ,decemb] #ca1 #bjbf4 4 7c7 ,national advisory committee on individuals ) disabilities & disa/]s ,section #bhaa;,c ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;d7 is am5d$-- 7#a7 by r$esignat+ subsections 7c7 ?r\gh 7g7 z subsections 7d7 ?r\gh 7h71 respectively2 7#b7 by ins]t+ aft] subsection 7b7 ! foll[+3 7c7 ,additional duties ,! ,advisory ,committee may provide advice & recomm5dations to ! ,secret>y ) respect to individuals ) disabilities & ! m$ical & public heal? grants & coop]ative agreem5ts z applicable to prep>$ness & response activities "u ?is title & title ,,iii4 2 7#c7 9 subsection 7d71 z s r$esignat$-- 7,a7 9 p>agraph 7#a71 by /rik+ #ag memb]s & ins]t+ #be memb]s2 7,b7 9 p>agraph 7#b7-- 7i7 by /rik+ subp>agraphs 7,k7 ?r\gh 7,m72 7ii7 by r$esignat+ subp>agraphs 7,a7 ?r\gh 7,j7 z clauses 7i7 ?r\gh 7x71 respectively1 & adju/+ ! m>g9s accord+ly2 7iii7 by ins]t+ be=e clause 7i71 z s r$esignat$1 ! foll[+3 7,b7 ,f$]al memb]s ,! ,f$]al memb]s %all include ! foll[+3 2 7iv7 by add+ at ! end ( subp>agraph 7,b71 z s designat$1 ! foll[+3 7xi7 ,repres5tatives ( su* o!r ,f$]al ag5cies z ! ,secret>y det]m9es necess>y to fulfill ! duties ( ! ,advisory ,committee4 2 & 7v7 by ins]t+ be=e subp>agraph 7,b71 z s designat$1 ! foll[+3 7,a7 ,non-,f$]al memb]s ,! ,secret>y 9 consultation ) su* o!r heads ( ag5cies & dep>tm5ts z may be appropriate1 %all appo9t to ! ,advisory ,committee "u p>agraph 7#a7 at lea/ #ac individuals1 includ+ ! foll[+3 7i7 ,at lea/ #d non-,f$]al heal? c>e pr(essionals ) exp]tise 9 disability accessibility be=e1 dur+1 & aft] disa/]s1 m$ical & mass c>e disa/] plann+1 prep>$ness1 response1 or recov]y4 7ii7 ,at lea/ #c repres5tatives ( ,/ate1 local1 ,tribal1 or t]ritorial ag5cies ) exp]tise 9 disa/] plann+1 prep>$ness1 response1 or recov]y = individuals ) disabilities4 7iii7 ,at lea/ #d individuals ) a disability ) exp]tise 9 disa/] plann+1 prep>$ness1 response1 or recov]y = individuals ) disabilities4 7iv7 ,o!r memb]s z ! ,secret>y det]m9es appropriate1 ( :om-- 7,i7 at lea/ "o su* memb] %all repres5t a local1 ,/ate1 or national organization ) exp]tise 9 individuals ) disabilities2 7,,ii7 at lea/ "o su* memb] %all be an individual ) a disability2 & 7,,iii7 at lea/ "o su* memb] %all be an individual ) exp]tise 9 ! ne$s ( h\s+ s]vices1 includ+ dur+ ! response to1 & recov]y f1 disa/]s4 2 & 7,c7 by add+ at ! end ! foll[+3 7#c7 ,consid]ation ,9 appo9t+ memb]s1 includ+ ! ,*air1 to ! ,committee "u ?is subsection1 ! ,secret>y may give consid]ation to disability /atus4 2 & 7#d7 by am5d+ subsection 7h71 z s r$esignat$1 to read z foll[s3 7h7 ,sunset ,! ,advisory ,committee %all t]m9ate on ,decemb] #ca1 #bjbf4 4 #fcd4 ,national ,academies /udy on prizes 7a7 ,9 g5]al ,n lat] ?an #ij days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all seek to ent] into an agreem5t ) ! ,national ,academies ( ,sci5ces1 ,eng9e]+1 & ,m$ic9e 7ref]r$ to 9 ?is section z ! ,national ,academies7 to conduct a /udy to exam9e-- 7#a7 alt]native models = directly fund+1 or /imulat+ inve/m5t 91 biom$ical rese>* & developm5t t del9k rese>* & developm5t co/s f ! prices ( drugs1 includ+ ! progressive replacem5t ( pat5ts & regulatory exclusivities on new drugs ) a comb9ation ( exp&$ support = rese>* & innovation prizes to rew>d ! successful developm5t ( drugs or a*ievem5t ( relat$ mile/ones2 7#b7 ! doll> am\nt ( innovation prizes = diff]5t /ages ( rese>* & developm5t ( diff]5t classes or types ( drugs1 & total annual fund+1 t w\ld be necess>y to /imulate inve/m5t suffici5t to a*ieve su* successful drug developm5t & relat$ mile/ones2 7#c7 ! relative effectiv5ess & effici5cy ( su* alt]native models 9 /imulat+ innovation1 comp>$ to ! /atus quo t includes pat5ts & regulatory exclusivities2 7#d7 /rategies to implem5t su* alt]native models describ$ 9 p>agraph 7#a71 includ+ a phas$ transition2 & 7#e7 ! anticipat$ economic & societal impacts ( su* alt]native models1 includ+ an assessm5t ( impact on-- 7,a7 ! numb] & v>iety ( new drugs t w\ld be develop$1 approv$1 & m>ket$ 9 ! ,unit$ ,/ates1 includ+ su* new drugs int5d$ to prev5t1 diagnose1 or treat a r>e disease or condition2 7,b7 ! rate at :i* new drugs w\ld be develop$1 approv$1 & m>ket$ 9 ! ,unit$ ,/ates2 7,c7 access to m$ication2 7,d7 heal? outcomes2 7,e7 av]age lifespan & disease burd5 9 ! ,unit$ ,/ates2 7,f7 ! numb] ( manufactur]s t w\ld be seek+ approval = a drug or br++ a drug to m>ket = ! fir/ "t2 7,g7 ,f$]al discretion>y & m&atory sp5d+2 & 7,h7 public & private insurance m>kets4 7b7 ,requirem5ts ,9 conduct+ ! /udy pursuant to subsection 7a71 ! ,national ,academies %all hold n few] ?an #b public li/5+ sessions to solicit fe$back f int]e/$ p>ties1 includ+ repres5tatives ( academia1 pr(essional societies1 pati5t advocates1 public heal? organizations1 relevant ,f$]al dep>tm5ts & ag5cies1 drug develop]s1 repres5tatives ( o!r relevant indu/ries1 & subject matt] exp]ts4 7c7 ,report ,n lat] ?an #b ye>s aft] ! agreem5t "u subsection 7a71 ! ,national ,academies %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,appropriations ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives a report on ! /udy conduct$ pursuant to subsection 7a74 ,d ,additional reau?orizations #fda4 ,m$ical c\nt]measure priority review v\*] ,section #efe;,a7g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d;a7 is am5d$ by /rik+ ,octob] #a1 #bjbc & ins]t+ ,decemb] #ca1 #bjbf4 #fdb4 ,epidemic ,intellig5ce ,s]vice ,section #cag;,f7c77#b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;b-#g7;c77#b77 is am5d$ by /rik+ #bjai ?r\gh #bjbc & ins]t+ #bjbe & #bjbf1 to rema9 available ?r\gh ,decemb] #ca1 #bjbf4 #fdc4 ,monitor+ & di/ribution ( c]ta9 m$ical c\nt]measures ,section #cai;,a7e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#a7;e77 is am5d$ by /rik+ #bjai ?r\gh #bjbc & ins]t+ #bjbe & #bjbf1 to rema9 available ?r\gh ,decemb] #ca1 #bjbf4 #fdd4 ,regional heal? c>e em]g5cy prep>$ness & response sy/ems ,section #cai;,c-#c ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#c;c7 is am5d$-- 7#a7 9 subsection 7b77#c71 by /rik+ "u ! & all t foll[s ?r\gh su* ,act7 & ins]t+ "u law2 & 7#b7 9 subsection 7e77#b71 by /rik+ ,septemb] #cj1 #bjbc & ins]t+ ,decemb] #ca1 #bjbf4 #fde4 ,em]g5cy sy/em = advance regi/ration ( volunte] heal? pr(essionals 7#a7 ,9 g5]al ,section #cai;,i ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#g;b7 is am5d$-- 7,a7 9 subsection 7a71 by /rik+ ,n lat] ?an #ab mon?s aft] ! date ( enactm5t ( ! ,p&emic & ,all-,haz>ds ,prep>$ness ,act1 ! ,secret>y %all l9k exi/+ ,/ate v]ification sy/ems to ma9ta9 a s+le national int]op]able network ( sy/ems1 & ins]t+ ,! ,secret>y %all cont9ue to ma9ta9 a s+le national int]op]able network ( v]ification sy/ems1 & 7,b7 9 subsection 7k71 by /rik+ #bjai ?r\gh #bjbc & ins]t+ #bjbe & #bjbf1 to rema9 available ?r\gh ,decemb] #ca1 #bjbf4 #fdf4 ,ensur+ collaboration & coord9ation 9 m$ical c\nt]measure developm5t ,section #cai,l-#a7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#g;f7b77 is am5d$ by /rik+ ,m>* #ca1 #bjbe & ins]t+ ,decemb] #ca1 #bjbf4 #fdg4 ,milit>y & civilian p>tn]%ip = trauma read9ess ,section #abia7;g7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;d-#ia7;g77 is am5d$ by /rik+ #bjai ?r\gh #bjbc & ins]t+ #bjbe & #bjbf1 to rema9 available ?r\gh ,decemb] #ca1 #bjbf4 #fdh4 ,national ,disa/] ,m$ical ,sy/em ,section #bhab ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#aa7 is am5d$-- 7#a7 9 subsection 7c77#d77;,b71 by /rik+ ,m>* #ca1 #bjbe & ins]t+ ,decemb] #ca1 #bjbf2 & 7#b7 9 subsection 7g71 by /rik+ #eg1djj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc & ins]t+ #fe1ijj1jjj = ea* ( fiscal ye>s #bjbe & #bjbf1 to rema9 available ?r\gh ,decemb] #ca1 #bjbf4 #fdi4 ,volunte] ,m$ical ,res]ve ,corps ,section #bhac7;i7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#ae7;i77 is am5d$ by /rik+ #bjai ?r\gh #bjbc & ins]t+ #bjbe ?r\gh #bjbf1 to rema9 available ?r\gh ,decemb] #ca1 #bjbf4 #fdi;,a4 ,epidemiology-laboratory capacity ,section #bhba7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;hh-#ca7;b77 is am5d$1 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ #bjai ?r\gh #bjbc & ins]t+ #bjbe & #bjbf1 to rema9 available ?r\gh ,decemb] #ca1 #bjbf4 ,,vii ,public ,heal? ,programs #gja4 ,action = d5tal heal? ,section #cdj;,g7f7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;g7f77 is am5d$ by /rik+ #ac1ijc1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc & ins]t+ #ae1jjj1jjj = ea* ( fiscal ye>s #bjbe ?r\gh #bjbi1 to rema9 available until exp5d$4 #gjb4 ,,preemie 7a7 ,rese>* relat+ to pret]m labor & deliv]y & ! c>e1 treatm5t1 & outcomes ( pret]m & l[ bir?weight infants 7#a7 ,9 g5]al ,section #c7;e7 ( ! ,prematurity ,rese>* ,expansion & ,education = ,mo!rs :o deliv] ,infants ,e>ly ,act 7#db ,u4,s4,c4 #bdg;b-#d;f7e77 is am5d$ by /rik+ fiscal ye>s #bjai ?r\gh #bjbc & ins]t+ fiscal ye>s #bjbe ?r\gh #bjbi4 7#b7 ,te*nical correction ,effective z if includ$ 9 ! enactm5t ( ! ,,preemie ,reau?orization ,act ( #bjah 7,public ,law #aae-cbh71 section #b ( su* ,act is am5d$1 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ ,section #b & ins]t+ ,section #c4 7b7 ,int]ag5cy work+ gr\p ,section #e7;a7 ( ! ,,preemie ,reau?orization ,act ( #bjah 7,public ,law #aae-cbh7 is am5d$ by /rik+ ,! ,secret>y ( ,heal? & ,human ,s]vices1 9 collaboration ) o!r dep>tm5ts1 z appropriate1 may e/abli% & ins]t+ ,n lat] ?an #ah mon?s aft] ! date ( ! enactm5t ( ! ,bip>tisan ,heal? ,c>e ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 9 collaboration ) o!r dep>tm5ts1 z appropriate1 %all e/abli%4 7c7 ,/udy on pret]m bir?s 7#a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices %all ent] into appropriate arrangem5ts ) ! ,national ,academies ( ,sci5ces1 ,eng9e]+1 & ,m$ic9e "u :i* ! ,national ,academies %all-- 7,a7 n lat] ?an #cj days aft] ! date ( enactm5t ( ?is ,act1 conv5e a committee ( exp]ts 9 mat]nal heal? to /udy premature bir?s 9 ! ,unit$ ,/ates2 & 7,b7 ^u completion ( ! /udy "u subp>agraph 7,a7-- 7i7 approve by cons5sus a report on ! results ( su* /udy2 7ii7 include 9 su* report-- 7,i7 an assessm5t ( ea* ( ! topics li/$ 9 p>agraph 7#b72 7,,ii7 ! analysis requir$ by p>agraph 7#c72 & 7,,iii7 ! raw data us$ to develop su* report2 & 7iii7 n lat] ?an #bd mon?s aft] ! date ( enactm5t ( ?is ,act1 transmit su* report to-- 7,i7 ! ,secret>y ( ,heal? & ,human ,s]vices2 7,,ii7 ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives2 & 7,,iii7 ! ,committee on ,f9ance & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate4 7#b7 ,assessm5t topics ,! topics li/$ 9 ?is subsection are ea* ( ! foll[+3 7,a7 ,! f9ancial co/s ( premature bir? to society1 includ+-- 7i7 an analysis ( /ays 9 neonatal int5sive c>e units & ! co/ ( su* /ays2 7ii7 long-t]m co/s ( /ays 9 su* units to society & ! family involv$ po/-dis*>ge2 & 7iii7 heal? c>e co/s = families po/-dis*>ge f su* units 7su* z m$ications1 !rapeutic s]vices1 co-paym5ts = visits1 & specialty equipm5t74 7,b7 ,! factors t impact pret]m bir? rates4 7,c7 ,opportunities = e>li] detection ( premature bir? risk factors1 includ+-- 7i7 opportunities to improve mat]nal & infant heal?2 & 7ii7 opportunities = public heal? programs to provide support & res\rces = p>5ts 9-hospital1 9 non-hospital sett+s1 & po/-dis*>ge4 7#c7 ,analysis ,! analysis requir$ by ?is subsection is an analysis (-- 7,a7 t>get$ rese>* /rategies to develop effective drugs1 treatm5ts1 or int]v5tions to br+ at-risk pregnancies to t]m2 7,b7 ,/ate & o!r programs' be/ practices ) respect to r$uc+ premature bir? rates2 & 7,c7 precision m$ic9e & prev5tative c>e approa*es />t+ e>ly 9 ! life c\rse 7includ+ dur+ pregnancy7 ) a focus on behavioral & biological influ5ces on premature bir?1 *ild heal?1 & ! trajectory ( su* approa*es into adul?ood4 #gjc4 ,prev5t+ mat]nal dea?s 7a7 ,mat]nal mortality review committee ,section #cag,k7d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;b-#ab7;d77 is am5d$-- 7#a7 9 p>agraph 7#a77;,a71 by ins]t+ 7includ+ ob/etricians & gynecologi/s7 aft] cl9ical specialties2 & 7#b7 9 p>agraph 7#c77;,a77i7-- 7,a7 9 subclause 7,i71 by /rik+ z applicable & ins]t+ if available2 & 7,b7 9 subclause 7,,iii71 by /rik+ 1 z appropriate & ins]t+ & coord9at+ ) dea? c]tifi]s to improve ! collection ( dea? record reports & ! quality ( dea? records1 includ+ by am5d+ cause ( dea? in=mation on a dea? c]tificate1 z appropriate4 7b7 ,be/ practices relat+ to ! prev5tion ( mat]nal mortality ,section #cag,k ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;b-#ab7 is am5d$-- 7#a7 by r$esignat+ subsections 7e7 & 7f7 z subsections 7f7 & 7g71 respectively2 & 7#b7 by ins]t+ aft] subsection 7d7 ! foll[+3 7e7 ,be/ practices relat+ to ! prev5tion ( mat]nal mortality 7#a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all1 9 consultation ) ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration1 dissem9ate to hospitals1 ,/ate pr(essional society gr\ps1 & p]9atal quality collaboratives1 be/ practices on h[ to prev5t mat]nal mortality & morbidity t consid] & reflect be/ practices id5tifi$ ?r\gh o!r relevant ,f$]al mat]nal heal? programs4 7#b7 ,frequ5cy ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all dissem9ate ! be/ practices ref]r$ to 9 p>agraph 7#a7 n less ?an once p] fiscal ye>4 4 7c7 ,ext5sion ,subsection 7g7 ( section #cag,k ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;b-#ab71 z r$esignat$ by subsection 7b71 is am5d$ by /rik+ #eh1jjj1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc & ins]t+ #ajj1jjj1jjj = ea* ( fiscal ye>s #bjbe ?r\gh #bjbi4 #gjd4 ,sickle cell disease prev5tion & treatm5t 7a7 ,9 g5]al ,section #aajf7;b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;b-#e7;b77 is am5d$-- 7#a7 9 p>agraph 7#a77;,a77iii71 by /rik+ prev5tion & treatm5t ( sickle cell disease & ins]t+ treatm5t ( sickle cell disease & ! prev5tion & treatm5t ( complications ( sickle cell disease2 7#b7 9 p>agraph 7#b77;,d71 by /rik+ prev5tion & treatm5t ( sickle cell disease & ins]t+ treatm5t ( sickle cell disease & ! prev5tion & treatm5t ( complications ( sickle cell disease2 7#c7 9 p>agraph 7#c7-- 7,a7 9 subp>agraph 7,a71 by /rik+ ent] into a contract ) & ins]t+ make a grant to1 or ent] into a contract or coop]ative agreem5t )12 & 7,b7 9 subp>agraph 7,b71 9 ea* ( clauses 7ii7 & 7iii71 by /rik+ prev5tion & treatm5t ( sickle cell disease & ins]t+ treatm5t ( sickle cell disease & ! prev5tion & treatm5t ( complications ( sickle cell disease2 & 7#d7 9 p>agraph 7#f71 by /rik+ #d1dee1jjj = ea* ( fiscal ye>s #bjai ?r\gh #bjbc & ins]t+ #h1bje1jjj = ea* ( fiscal ye>s #bjbe ?r\gh #bjbi4 7b7 ,s5se ( ,congress ,x is ! s5se ( ,congress t fur!r rese>* %\ld be und]tak5 to exp& ! und]/&+ ( ! causes (1 & to f9d cures =1 h]itable blood disord]s1 includ+ sickle cell disease4 #gje4 ,traumatic bra9 injuries 7a7 ,! ,bill ,pascrell1 ,jr41 national program = traumatic bra9 injury surveillance & regi/ries 7#a7 ,prev5tion ( traumatic bra9 injury ,section #cic;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;b-#a;c7 is am5d$-- 7,a7 9 subsection 7a71 by ins]t+ & preval5ce aft] incid5ce2 7,b7 9 subsection 7b7-- 7i7 9 p>agraph 7#a71 by ins]t+ & r$uction ( associat$ injuries & fatalities be=e ! semicolon2 7ii7 9 p>agraph 7#b71 by ins]t+ & relat$ risk factors be=e ! semicolon2 & 7iii7 9 p>agraph 7#c7-- 7,i7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ #bjbj ea* place x appe>s & ins]t+ #bjcj2 & 7,,ii7 9 subp>agraph 7,a7-- 7aa7 9 clause 7i71 by /rik+ 2 & & ins]t+ a semicolon2 7bb7 by r$esignat+ clause 7ii7 z clause 7iv72 7cc7 by ins]t+ aft] clause 7i7 ! foll[+3 7ii7 populations at high] risk ( traumatic bra9 injury1 includ+ populations ^: increas$ risk is due to occupational or circum/antial factors2 7iii7 causes (1 & risk factors =1 traumatic bra9 injury2 & 2 & 7dd7 9 clause 7iv71 z s r$esignat$1 by /rik+ aris+ f traumatic bra9 injury & ins]t+ 1 :i* may include relat$ m5tal heal? & o!r conditions1 aris+ f traumatic bra9 injury1 includ+2 & 7,c7 9 subsection 7c71 by ins]t+ 1 & o!r relevant ,f$]al dep>tm5ts & ag5cies be=e ! p]iod at ! end4 7#b7 ,national program = traumatic bra9 injury surveillance & regi/ries ,section #cic;,c ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;b-#a;d7 is am5d$-- 7,a7 by am5d+ ! section head+ to read z foll[s3 ,! ,bill ,pascrell1 ,jr41 national program = traumatic bra9 injury surveillance & regi/ries2 7,b7 9 subsection 7a7-- 7i7 9 ! matt] prec$+ p>agraph 7#a71 by ins]t+ to id5tify populations t may be at high] risk = traumatic bra9 injuries1 to collect data on ! causes (1 & risk factors =1 traumatic bra9 injuries1 aft] relat$ disability12 7ii7 9 p>agraph 7#a71 by ins]t+ 1 includ+ ! occupation ( ! individual1 :5 relevant to ! circum/ances surr\nd+ ! injury be=e ! semicolon2 & 7iii7 9 p>agraph 7#d71 by ins]t+ %ort- & long-t]m be=e outcomes2 7,c7 by /rik+ subsection 7b72 7,d7 by r$esignat+ subsection 7c7 z subsection 7b72 7,e7 9 subsection 7b71 z s r$esignat$1 by ins]t+ & evid5ce-bas$ practices to id5tify & address concussion be=e ! p]iod at ! end2 & 7,f7 by add+ at ! end ! foll[+3 7c7 ,availability ( in=mation ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,c5t]s = ,disease ,control & ,prev5tion1 %all make publicly available aggregat$ in=mation on traumatic bra9 injury & concussion describ$ 9 ?is section1 includ+ on ! website ( ! ,c5t]s = ,disease ,control & ,prev5tion4 ,su* website1 to ! ext5t feasible1 %all include aggregat$ in=mation on populations t may be at high] risk = traumatic bra9 injuries & /rategies = prev5t+ or r$uc+ risk ( traumatic bra9 injury t are tailor$ to su* populations4 4 7#c7 ,au?orization ( appropriations ,section #cid;,a ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhj;b-#c7 is am5d$-- 7,a7 9 subsection 7a71 by /rik+ #aiid1 & & ins]t+ #aiid12 & 7,b7 9 subsection 7b71 by /rik+ #bjbj ?r\gh #bjbd & ins]t+ #bjbe ?r\gh #bjbi4 7b7 ,/ate grant programs 7#a7 ,/ate grants = projects reg>d+ traumatic bra9 injury ,section #abeb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;d-#eb7 is am5d$-- 7,a7 9 subsection 7b77#b7-- 7i7 by ins]t+ 1 tak+ into consid]ation populations t may be at high] risk = traumatic bra9 injuries aft] outrea* programs2 & 7ii7 by ins]t+ ,tribal1 aft] ,/ate12 7,b7 9 subsection 7c71 by add+ at ! end ! foll[+3 7#c7 ,ma9t5ance ( ef=t ,) respect to activities = :i* a grant aw>d$ "u subsection 7a7 is to be exp5d$1 a ,/ate or ,am]ican ,indian consortium %all agree to ma9ta9 exp5ditures ( non-,f$]al am\nts = su* activities at a level t is n less ?an ! level ( su* exp5ditures ma9ta9$ by ! ,/ate or ,am]ican ,indian consortium = ! fiscal ye> prec$+ ! fiscal ye> = :i* ! ,/ate or ,am]ican ,indian consortium receives su* a grant4 7#d7 ,waiv] ,! ,secret>y may1 ^u ! reque/ ( a ,/ate or ,am]ican ,indian consortium1 waive n m ?an #ej p]c5t ( ! mat*+ fund am\nt "u p>agraph 7#a71 if ! ,secret>y det]m9es t su* mat*+ fund am\nt w\ld result 9 an inability ( ! ,/ate or ,am]ican ,indian consortium to c>ry out ! purposes "u subsection 7a74 ,a waiv] provid$ by ! ,secret>y "u ?is p>agraph %all apply only to ! fiscal ye> involv$4 2 7,c7 9 subsection 7e77#c77;,b7-- 7i7 by /rik+ 7su* z ?ird p>ty pay]s1 ,/ate ag5cies1 community-bas$ provid]s1 s*ools1 & educators72 & 7ii7 by ins]t+ 7su* z ?ird p>ty pay]s1 ,/ate ag5cies1 community-bas$ provid]s1 s*ools1 & educators7 aft] pr(essionals2 7,d7 9 subsection 7h71 by /rik+ p>agraphs 7#a7 & 7#b7 & ins]t+ ! foll[+3 7#a7 ,am]ican ,indian consortium2 ,/ate ,! t]ms ,am]ican ,indian consortium & ,/ate h ! mean+s giv5 su* t]ms 9 section #abec4 7#b7 ,traumatic bra9 injury 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 ! t]m traumatic bra9 injury-- 7i7 means an acquir$ injury to ! bra92 7ii7 may include-- 7,i7 bra9 injuries caus$ by anoxia due to trauma2 & 7,,ii7 damage to ! bra9 f an int]nal or ext]nal s\rce t results 9 infection1 toxicity1 surg]y1 or vascul> disord]s n associat$ ) ag+2 & 7iii7 does n include bra9 dysfunction caus$ by cong5ital or deg5]ative disord]s1 or bir? trauma4 7,b7 ,revisions to def9ition ,! ,secret>y may revise ! def9ition ( ! t]m traumatic bra9 injury "u ?is p>agraph1 z ! ,secret>y det]m9es necess>y1 aft] consultation ) ,/ates & o!r appropriate public or nonpr(it private entities4 2 & 7,e7 9 subsection 7i71 by /rik+ #bjbj ?r\gh #bjbd & ins]t+ #bjbe ?r\gh #bjbi4 7#b7 ,/ate grants = protection & advocacy s]vices ,section #abec7l7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;d-#ec7l77 is am5d$ by /rik+ #bjbj ?r\gh #bjbd & ins]t+ #bjbe ?r\gh #bjbi4 7c7 ,report to ,congress ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is ,act z ! ,secret>y7 %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report t conta9s-- 7#a7 an ov]view ( populations :o may be at high] risk = traumatic bra9 injury1 su* z individuals affect$ by dome/ic viol5ce or sexual assault & public safety (fic]s z def9$ 9 section #abjd ( ! ,omnibus ,crime ,control & ,safe ,/reets ,act ( #aifh 7#cd ,u4,s4,c4 #ajbhd72 7#b7 an outl9e ( exi/+ surveys & activities ( ! ,c5t]s = ,disease ,control & ,prev5tion on traumatic bra9 injuries & any /eps ! ag5cy has tak5 to address gaps 9 data collection relat$ to su* high] risk populations1 :i* may include lev]ag+ surveys su* z ! ,national ,intimate ,p>tn] & ,sexual ,viol5ce ,survey to collect data on traumatic bra9 injuries2 7#c7 an ov]view ( any outrea* or education ef=ts to rea* su* high] risk populations2 & 7#d7 any *all5ges associat$ ) rea*+ su* high] risk populations4 7d7 ,/udy on long-,t]m symptoms or conditions relat$ to traumatic bra9 injury 7#a7 ,9 g5]al ,! ,secret>y1 9 consultation ) /akehold]s & ! heads ( o!r relevant ,f$]al dep>tm5ts & ag5cies1 z appropriate1 %all conduct1 ei!r directly or ?r\gh a contract ) a nonpr(it private entity1 a /udy to-- 7,a7 exam9e ! incid5ce & preval5ce ( long-t]m or *ronic symptoms or conditions 9 individuals :o h exp]i5c$ a traumatic bra9 injury2 7,b7 exam9e ! evid5ce base ( rese>* relat$ to ! *ronic effects ( traumatic bra9 injury across ! lifespan2 7,c7 exam9e any correlations betwe5 traumatic bra9 injury & increas$ risk ( o!r conditions1 su* z dem5tia & m5tal heal? conditions2 7,d7 assess exi/+ s]vices available = individuals ) su* long-t]m or *ronic symptoms or conditions2 & 7,e7 id5tify any gaps 9 rese>* relat$ to su* long-t]m or *ronic symptoms or conditions ( individuals :o h exp]i5c$ a traumatic bra9 injury4 7#b7 ,public report ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all-- 7,a7 submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report detail+ ! f9d+s1 conclusions1 & recomm5dations ( ! /udy describ$ 9 p>agraph 7#a72 & 7,b7 9 ! case t su* /udy is conduct$ directly by ! ,secret>y1 make ! report describ$ 9 subp>agraph 7,a7 publicly available on ! website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 #gjf4 ,lifespan respite c>e 7a7 ,def9ition ( family c>egiv] ,section #bija7e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;ii7#e77 is am5d$ by /rik+ unpaid adult & ins]t+ unpaid individual4 7b7 ,fund+ ,section #bije ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;ii-#d7 is am5d$ by /rik+ fiscal ye>s #bjbj ?r\gh fiscal ye> #bjbd & ins]t+ fiscal ye>s #bjbe ?r\gh #bjbi4 #gjg4 ,dr4 ,lorna ,bre5 heal? c>e provid] protection 7a7 ,dissem9ation ( be/ practices ,section #b ( ! ,dr4 ,lorna ,bre5 ,heal? ,c>e ,provid] ,protection ,act 7,public ,law #aag-aje7 is am5d$ by /rik+ #b ye>s & ins]t+ #e ye>s4 7b7 ,education & aw>5ess initiative enc\rag+ use ( m5tal heal? & sub/ance use disord] s]vices by heal? c>e pr(essionals ,section #c ( ! ,dr4 ,lorna ,bre5 ,heal? ,c>e ,provid] ,protection ,act 7,public ,law #aag-aje7 is am5d$-- 7#a7 9 subsection 7b71 by ins]t+ & annually !reaft]1 aft] ( ?is ,act12 & 7#b7 9 subsection 7c71 by /rik+ #bjbb ?r\gh #bjbd & ins]t+ #bjbe ?r\gh #bjbi4 7c7 ,programs ,to promote m5tal heal? among ! heal? pr(essional work=ce ,! second section #gfd ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bidt71 z add$ by section #d ( ! ,dr4 ,lorna ,bre5 ,heal? ,c>e ,provid] ,protection ,act 7,public ,law #aag-aje71 is am5d$-- 7#a7 by r$esignat+ su* section #gfd z section #gfd;,a2 7#b7 9 subsection 7a77#c7-- 7,a7 by /rik+ to eligible entities 9 & ins]t+ 8to eligible entities t-- 7,a7 are 9 2 7,b7 by /rik+ ! p]iod & ins]t+ 2 or2 & 7,c7 by add+ at ! end ! foll[+3 7,b7 h a focus on ! r$uction ( adm9i/rative burd5 on heal? c>e work]s4 2 7#c7 9 subsection 7c71 by ins]t+ n less ?an aft] p]iod (2 & 7#d7 9 subsection 7f71 by /rik+ #bjbb ?r\gh #bjbd & ins]t+ #bjbe ?r\gh #bjbi4 #gjh4 ,,scre5s = ,canc] 7a7 ,national ,brea/ & ,c]vical ,canc] ,e>ly ,detection ,program ,title ,,xv ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjjk et seq47 is am5d$-- 7#a7 9 section #aeja 7#db ,u4,s4,c4 #cjjk7-- 7,a7 9 subsection 7a7-- 7i7 9 p>agraph 7#b71 by /rik+ ! provision ( appropriate foll[-up s]vices & support s]vices su* z case managem5t & ins]t+ t appropriate foll[-up s]vices are provid$2 7ii7 9 p>agraph 7#c71 by /rik+ programs = ! detection & control & ins]t+ = ! prev5tion1 detection1 & control2 7iii7 9 p>agraph 7#d71 by /rik+ ! detection & control & ins]t+ ! prev5tion1 detection1 & control2 7iv7 9 p>agraph 7#e7-- 7,i7 by /rik+ monitor & ins]t+ ensure2 & 7,,ii7 by /rik+ 2 & & ins]t+ a semicolon2 7v7 by r$esignat+ p>agraph 7#f7 z p>agraph 7#i72 7vi7 by ins]t+ aft] p>agraph 7#e7 ! foll[+3 7#f7 to enhance appropriate support activities to increase brea/ & c]vical canc] scre5+s1 su* z navigation ( heal? c>e s]vices1 implem5tation ( evid5ce-bas$ or evid5ce-in=m$ /rategies to increase brea/ & c]vical canc] scre5+ 9 heal? c>e sett+s1 & facilitation ( access to heal? c>e sett+s2 7#g7 to r$uce disp>ities 9 brea/ & c]vical canc] incid5ce1 morbidity1 & mortality1 includ+ 9 populations ) high] ?an av]age rates2 7#h7 to improve access to brea/ & c]vical canc] scre5+ & diagno/ic s]vices & r$uce relat$ b>ri]s1 includ+ factors t relate to negative heal? outcomes2 & 2 & 7vii7 9 p>agraph 7#i71 z s r$esignat$1 by /rik+ ?r\gh 7#e7 & ins]t+ ?r\gh 7#h72 & 7,b7 by /rik+ subsection 7d72 7#b7 9 section #aejc 7#db ,u4,s4,c4 #cjjm7-- 7,a7 9 subsection 7a7-- 7i7 9 p>agraph 7#a71 by /rik+ t1 initially & all t foll[s ?r\gh ! semicolon & ins]t+ t appropriate brea/ & c]vical canc] scre5+ & diagno/ic s]vices are provid$ consi/5t ) relevant evid5ce-bas$ recomm5dations2 &2 7ii7 by /rik+ p>agraphs 7#b7 & 7#d72 7iii7 by r$esignat+ p>agraph 7#c7 z p>agraph 7#b72 & 7iv7 9 p>agraph 7#b71 z s r$esignat$1 by /rik+ 2 & & ins]t+ a p]iod2 & 7,b7 by /rik+ subsection 7d72 7#c7 9 section #aejh7;b7 7#db ,u4,s4,c4 #cjjn-#d7;b77-- 7,a7 by /rik+ #a ye> aft] ! date ( ! enactm5t ( ! ,national ,brea/ & ,c]vical ,canc] ,e>ly ,detection ,program ,reau?orization ( #bjjg1 & annually !reaft]1 & ins]t+ #b ye>s aft] ! date ( enactm5t ( ! ,bip>tisan ,heal? ,c>e ,act1 & e #e ye>s !reaft]12 7,b7 by /rik+ ,labor & ,human ,res\rces & ins]t+ ,heal?1 ,education1 ,labor1 & ,p5sions2 & 7,c7 by /rik+ prec$+ fiscal ye> & ins]t+ prec$+ #b fiscal ye>s 9 ! case ( ! fir/ report aft] ! date ( enactm5t ( ! ,bip>tisan ,heal? ,c>e ,act & prec$+ #e fiscal ye>s = ea* report !reaft]2 & 7#d7 9 section #aeaj7;a7 7#db ,u4,s4,c4 #cjjn-#e7;a77-- 7,a7 by /rik+ #bjaa1 & & ins]t+ #bjaa12 & 7,b7 by ins]t+ 1 & #bce1ejj1jjj = ea* ( fiscal ye>s #bjbe ?r\gh #bjbi be=e ! p]iod at ! end be=e ! p]iod at ! end4 7b7 ,,gao /udy ,n lat] ?an ,septemb] #cj1 #bjbg1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all report to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives on ! "w ( ! ,national ,brea/ & ,c]vical ,canc] ,e>ly ,detection ,program1 includ+-- 7#a7 an e/imate ( ! numb] ( individuals eligible = s]vices provid$ "u su* program2 7#b7 a summ>y ( tr5ds 9 ! numb] ( individuals s]v$ ?r\gh su* program2 & 7#c7 an assessm5t ( any factors t may be driv+ ! tr5ds id5tifi$ "u p>agraph 7#b71 includ+ any b>ri]s to access+ brea/ & c]vical canc] scre5+s provid$ by su* program4 #gji4 ,de,ondra ,dixon ,,include ,project ,"p ,b ( title ,,iv ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhd et seq47 is am5d$ by add+ at ! end ! foll[+3 #dji,k4 ,d[n syndrome rese>* 7a7 ,9 g5]al ,! ,director ( ,,nih %all c>ry out a program ( rese>*1 tra9+1 & inve/igation relat$ to ,d[n syndrome to be kn[n z ! ,i,nvestigation ( ,co-occurr+ conditions across ! ,lifespan to ,und]/& ,d[n syndrom,e ,project or ! ,,include ,project4 7b7 ,program elem5ts ,! program "u subsection 7a7 %all include-- 7#a7 high-risk1 high rew>d rese>* on ! effects ( trisomy #ba on human developm5t & heal?2 7#b7 promot+ rese>* = p>ticipants ) ,d[n syndrome across ! lifespan1 includ+ cohort /udies to facilitate improv$ und]/&+ ( ,d[n syndrome & co-occurr+ conditions & developm5t ( new int]v5tions2 7#c7 exp&+ ! numb] ( cl9ical trials t are inclusive (1 or expressly =1 p>ticipants ) ,d[n syndrome1 includ+ novel biom$ical & ph>macological int]v5tions & o!r !rapies design$ to promote or enhance activities ( daily liv+2 7#d7 rese>* on ! biological me*anisms 9 individuals ) ,d[n syndrome p]ta9+ to /ructural1 functional1 & behavioral anomalies & dysfunction z well z /unt$ gr[?2 7#e7 support+ rese>* to improve diagnosis & treatm5t ( conditions co-occurr+ ) ,d[n syndrome1 includ+ ! id5tification ( biom>k]s relat$ to risk factors1 diagnosis1 & cl9ical rese>* & !rapeutics2 7#f7 rese>* on ! causes ( increas$ preval5ce1 & concurr5t treatm5t1 ( co-occurr+ conditions1 su* z ,alzheim]'s disease & relat$ dem5tias & autoimmunity1 9 individuals ) ,d[n syndrome2 & 7#g7 rese>*1 tra9+1 & inve/igation on improv+ ! quality ( life ( individuals ) ,d[n syndrome & _! families4 7c7 ,coord9ation2 ,prioritiz+ nonduplicative rese>* ,! ,director ( ,,nih %all ensure t-- 7#a7 ! programs & activities ( ! in/itutes & c5t]s ( ! ,national ,in/itutes ( ,heal? relat+ to ,d[n syndrome & co-occurr+ conditions are coord9at$1 includ+ ?r\gh ! ,(fice ( ! ,director ( ,,nih & priority-sett+ reviews conduct$ pursuant to section #djb7;b77#c72 & 7#b7 su* in/itutes & c5t]s1 prioritize1 z appropriate1 ,d[n syndrome rese>* t does n duplicate exi/+ rese>* activities ( ! ,national ,in/itutes ( ,heal?4 7d7 ,consultation ) /akehold]s ,9 c>ry+ out activities "u ?is section1 ! ,director ( ,,nih %all1 z appropriate & to ! maximum ext5t feasible1 consult ) relevant /akehold]s1 includ+ pati5t advocates1 to ensure t su* activities take into consid]ation ! ne$s ( individuals ) ,d[n syndrome4 7e7 ,bi5nial reports to ,congress 7#a7 ,9 g5]al ,! ,director ( ,,nih %all submit1 on a bi5nial basis1 to ! ,committee on ,en]gy & ,comm]ce & ! ,subcommittee on ,labor1 ,heal? & ,human ,s]vices1 ,education1 & ,relat$ ,ag5cies ( ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,subcommittee on ,labor1 ,heal? & ,human ,s]vices1 ,education1 & ,relat$ ,ag5cies ( ! ,committee on ,appropriations ( ! ,s5ate1 a report t catalogs ! rese>* conduct$ or support$ "u ?is section4 7#b7 ,cont5ts ,ea* report "u p>agraph 7#a7 %all include-- 7,a7 id5tification ( ! in/itute or c5t] involv$2 7,b7 a /atem5t ( :e!r ! rese>* is or 0 be+ c>ri$ out directly by su* in/itute or c5t] or by multiple in/itutes & c5t]s2 & 7,c7 id5tification ( any result+ real-_w evid5ce t is or may be us$ = cl9ical rese>* & m$ical c>e = pati5ts ) ,d[n syndrome4 4 #gaj4 ,,improve ,initiative ,"p ,b ( title ,,iv ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhd et seq471 z am5d$ by section #gaj1 is fur!r am5d$ by add+ at ! end ! foll[+3 #dji,l4 ,,improve initiative 7a7 ,9 g5]al ,! ,director ( ! ,national ,in/itutes ( ,heal? %all c>ry out a program ( rese>* to improve heal? outcomes to be kn[n z ! ,implem5t+ a ,mat]nal heal? & ,p,regnancy ,outcomes ,vision = ,ev]yone ,initiative 7ref]r$ to 9 ?is section z ! ,initiative74 7b7 ,objectives ,! ,initiative %all-- 7#a7 advance rese>* to-- 7,a7 r$uce prev5table causes ( mat]nal mortality & sev]e mat]nal morbidity2 7,b7 r$uce heal? disp>ities relat$ to mat]nal heal? outcomes1 includ+ su* disp>ities associat$ ) m$ically und]s]v$ populations2 & 7,c7 improve heal? = pregnant & po/p>tum wom5 be=e1 dur+1 & aft] pregnancy2 7#b7 use an integrat$ approa* to und]/& ! factors1 includ+ biological1 behavioral1 & o!r factors1 t affect mat]nal mortality & sev]e mat]nal morbidity by build+ an evid5ce base = improv$ outcomes 9 specific regions ( ! ,unit$ ,/ates2 & 7#c7 t>get heal? disp>ities associat$ ) mat]nal mortality & sev]e mat]nal morbidity by-- 7,a7 implem5t+ & evaluat+ community-bas$ int]v5tions = disproportionately affect$ wom52 & 7,b7 id5tify+ risk factors & ! und]ly+ biological me*anisms associat$ ) lead+ causes ( mat]nal mortality & sev]e mat]nal morbidity 9 ! ,unit$ ,/ates4 7c7 ,sunset ,! au?ority "u ?is section %all expire on ,septemb] #cj1 #bjbi4 4 #gaa4 ,organ ,procurem5t & ,transplantation ,network ,section #cgb ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bgd7 is am5d$-- 7#a7 9 subsection 7b77#b7-- 7,a7 by mov+ ! m>g9s ( subp>agraphs 7,m7 ?r\gh 7,o7 #b ems to ! left2 7,b7 9 subp>agraph 7,a7-- 7i7 9 clause 7i71 by /rik+ 1 & & ins]t+ 2 &2 & 7ii7 9 clause 7ii71 by /rik+ ! comma at ! end & ins]t+ a semicolon2 7,c7 9 subp>agraph 7,c71 by /rik+ tw5ty-f\r-h\r telephone s]vice & ins]t+ #bd-;h\r telephone or in=mation te*nology s]vice2 7,d7 9 ea* ( subp>agraphs 7,b7 ?r\gh 7,m71 by /rik+ ! comma at ! end & ins]t+ a semicolon2 7,e7 9 subp>agraph 7,n71 by /rik+ transportation1 & & ins]t+ transportation22 7,f7 9 subp>agraph 7,o71 by /rik+ ! p]iod & ins]t+ a semicolon2 & 7,g7 by add+ at ! end ! foll[+3 7,p7 enc\rage ! integration ( electronic heal? records sy/ems ?r\gh application programm+ int]faces 7or successor te*nologies7 among hospitals1 organ procurem5t organizations1 & transplant c5t]s1 includ+ ! use ( automat$ electronic hospital ref]rals & ! grant ( remote1 electronic access to hospital electronic heal? records ( pot5tial donors by organ procurem5t organizations1 9 a mann] t complies ) ! privacy regulations promulgat$ "u ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif1 at "p #afj ( title #de1 ,code ( ,f$]al ,regulations1 & subp>ts ,a1 ,c1 & ,e ( "p #afd ( su* title 7or any successor regulations72 & 7,q7 consid] e/abli%+ a da%bo>d to display ! numb] ( transplants p]=m$1 ! types ( transplants p]=m$1 ! numb] & types ( organs t ent]$ ! ,organ ,procurem5t & ,transplantation ,network sy/em & fail$ to be transplant$1 & o!r appropriate /ati/ics1 :i* %\ld be updat$ m frequ5tly ?an annually4 2 & 7#b7 by add+ at ! end ! foll[+3 7d7 ,regi/ration fees 7#a7 ,9 g5]al ,! ,secret>y may collect regi/ration fees f any memb] ( ! ,organ ,procurem5t & ,transplantation ,network = ea* transplant c&idate su* memb] places on ! li/ describ$ 9 subsection 7b77#b77;,a77i74 ,su* regi/ration fees %all be collect$ & di/ribut$ only to support ! op]ation ( ! ,organ ,procurem5t & ,transplantation ,network4 ,su* regi/ration fees are au?oriz$ to rema9 available until exp5d$4 7#b7 ,collection ,! ,secret>y may collect ! regi/ration fees "u p>agraph 7#a7 directly or ?r\gh aw>ds made "u subsection 7b77#a77;,a74 7#c7 ,di/ribution ,any am\nts collect$ "u ?is subsection %all-- 7,a7 be cr$it$ to ! curr5tly applicable appropriation1 acc\nt1 or fund ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices z discretion>y (fsett+ collections2 & 7,b7 be available1 only to ! ext5t & 9 ! am\nts provid$ 9 advance 9 appropriations ,acts1 to di/ribute su* fees among aw>dees describ$ 9 subsection 7b77#a77;,a74 7#d7 ,transp>5cy ,! ,secret>y %all-- 7,a7 promptly po/ on ! website ( ! ,organ ,procurem5t & ,transplantation ,network-- 7i7 ! am\nt ( regi/ration fees collect$ "u ?is subsection f ea* memb] ( ! ,organ ,procurem5t & ,transplantation ,network2 & 7ii7 a li/ ( activities su* fees are us$ to support2 & 7,b7 update ! in=mation po/$ pursuant to subp>agraph 7,a71 z applicable = ea* cal5d> qu>t] = :i* fees are collect$ "u p>agraph 7#a74 7#e7 ,,gao review ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is subsection1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all1 to ! ext5t data are available-- 7,a7 conduct a review conc]n+ ! activities "u ?is subsection2 & 7,b7 submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions & ! ,committee on ,f9ance ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives1 a report on su* review1 includ+ relat$ recomm5dations1 z applicable4 7#f7 ,sunset ,! au?ority to collect regi/ration fees "u p>agraph 7#a7 %all expire on ! date t is #c ye>s aft] ! date ( enactm5t ( ! ,bip>tisan ,heal? ,c>e ,act4 4 #gab4 ,honor ,our ,liv+ ,donors 7a7 ,no consid]ation ( income ( organ recipi5t ,section #cgg ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bgd;f7 is am5d$-- 7#a7 by r$esignat+ subsections 7c7 ?r\gh 7f7 z subsections 7d7 ?r\gh 7g71 respectively2 7#b7 by ins]t+ aft] subsection 7b7 ! foll[+3 7c7 ,no consid]ation ( income ( organ recipi5t ,! recipi5t ( a grant "u ?is section1 9 provid+ reimbursem5t to a donat+ individual ?r\gh su* grant1 %all n give any consid]ation to ! income ( ! organ recipi5t4 2 & 7#c7 9 subsection 7f71 z s r$esignat$-- 7,a7 9 p>agraph 7#a71 by /rik+ subsection 7c77#a7 & ins]t+ subsection 7d77#a72 & 7,b7 9 p>agraph 7#b71 by /rik+ subsection 7c77#b7 & ins]t+ subsection 7d77#b74 7b7 ,removal ( expectation ( paym5ts by organ recipi5ts ,section #cgg7;e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bgd;f7e771 z r$esignat$ by subsection 7a77#a71 is am5d$-- 7#a7 9 p>agraph 7#a71 by add+ or at ! end2 7#b7 9 p>agraph 7#b71 by /rik+ 2 or & ins]t+ a p]iod2 & 7#c7 by /rik+ p>agraph 7#c74 7c7 ,annual report ,section #cgg ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bgd;f71 z am5d$ by subsections 7a7 & 7b71 is am5d$ by add+ at ! end ! foll[+3 7h7 ,annual report ,n lat] ?an ,decemb] #ca ( ea* ye>1 beg9n+ 9 fiscal ye> #bjbf1 ! ,secret>y %all-- 7#a7 prep>e1 submit to ! ,congress1 & make public a report on :e!r grants "u ?is section provid$ adequate fund+ dur+ ! prec$+ fiscal ye> to reimburse all donat+ individuals p>ticipat+ 9 ! grant program "u ?is section = all qualify+ exp5ses2 & 7#b7 include 9 ea* su* report-- 7,a7 ! e/imat$ numb] ( all donat+ individuals p>ticipat+ 9 ! grant program "u ?is section :o did n receive reimbursem5t = all qualify+ exp5ses dur+ ! prec$+ fiscal ye>2 & 7,b7 ! total am\nt ( fund+ t is e/imat$ to be necess>y to fully reimburse all donat+ individuals p>ticipat+ 9 ! grant program "u ?is section = all qualify+ exp5ses4 4 #gac4 ,program = p$iatric /udies ( drugs ,section #dji;,i7d77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bhdm7d77#a77 is am5d$ by /rik+ section1 & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ section1 #be1jjj1jjj = ea* ( fiscal ye>s #bjbe ?r\gh #bjbg44 ,,viii ,food & ,drug ,adm9i/ration ,a ,give ,kids a ,*ance #hja4 ,rese>* into p$iatric uses ( drugs2 additional au?orities ( ,food & ,drug ,adm9i/ration reg>d+ molecul>ly t>get$ canc] drugs 7a7 ,9 g5]al 7#a7 ,additional active +r$i5t = application drug2 limitation reg>d+ novel-comb9ation application drug ,section #eje;,b7a77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77#c77 is am5d$-- 7,a7 by r$esignat+ subp>agraphs 7,b7 & 7,c7 z subp>agraphs 7,c7 & 7,d71 respectively2 & 7,b7 by /rik+ subp>agraph 7,a7 & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,= purposes ( p>agraph 7#a77;,b71 ! inve/igation describ$ 9 ?is p>agraph is a molecul>ly t>get$ p$iatric canc] inve/igation (-- 7i7 ! drug or biological product = :i* ! application ref]r$ to 9 su* p>agraph is submitt$2 or 7ii7 su* drug or biological product us$ 9 comb9ation )-- 7,i7 an active +r$i5t ( a drug or biological product-- 7aa7 = :i* an approv$ application "u section #eje7;j7 "u ?is ,act or "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act is 9 effect2 & 7bb7 t is det]m9$ by ! ,secret>y1 aft] consultation ) ! applicant1 to be "p ( ! /&>d ( c>e = treat+ a p$iatric canc]2 or 7,,ii7 an active +r$i5t ( a drug or biological product-- 7aa7 = :i* an approv$ application "u section #eje7;b7 ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act to treat an adult canc] is 9 effect & is held by ! same p]son submitt+ ! application "u p>agraph 7#a77;,b72 & 7bb7 t is direct$ at a molecul> t>get t ! ,secret>y det]m9es to be sub/antially relevant to ! gr[? or progression ( a p$iatric canc]4 7,b7 ,additional requirem5ts 7i7 ,design ( inve/igation ,a molecul>ly t>get$ p$iatric canc] inve/igation ref]r$ to 9 subp>agraph 7,a7 %all be design$ to yield cl9ically mean+ful p$iatric /udy data t is ga!r$ us+ appropriate =mulations = ea* age gr\p = :i* ! /udy is requir$1 reg>d+ dos+1 safety1 & prelim9>y efficacy to in=m pot5tial p$iatric label+4 7ii7 ,limitation ,an inve/igation describ$ 9 subp>agraph 7,a77ii7 may be requir$ only if ! drug or biological product = :i* ! application ref]r$ to 9 p>agraph 7#a77;,b7 conta9s ei!r-- 7,i7 a s+le new active +r$i5t2 or 7,,ii7 m ?an "o active +r$i5t1 if an application = ! comb9ation ( active +r$i5ts has n previ\sly be5 approv$ b ea* active +r$i5t is 9 a drug product t has be5 previ\sly approv$ to treat an adult canc]4 7iii7 ,results ( already-complet$ precl9ical /udies ( application drug ,) respect to an inve/igation requir$ pursuant to p>agraph 7#a77;,b71 ! ,secret>y may require ! results ( any complet$ precl9ical /udies relevant to ! initial p$iatric /udy plan be submitt$ to ! ,secret>y at ! same "t t ! initial p$iatric /udy plan requir$ "u subsection 7e77#a7 is submitt$4 7iv7 ,rule ( con/ruction reg>d+ inactive +r$i5ts ,) respect to a comb9ation ( active +r$i5ts ref]r$ to 9 subp>agraph 7,a77ii71 su* subp>agraph %all n be con/ru$ z address+ ! use ( inactive +r$i5ts ) su* comb9ation4 4 7#b7 ,det]m9ation ( applicable requirem5ts ,section #eje;,b7e77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7e77#a77 is am5d$ by add+ at ! end ! foll[+3 ,! ,secret>y %all det]m9e :e!r subp>agraph 7,a7 or 7,b7 ( subsection 7a77#a7 applies ) respect to an application be=e ! date on :i* ! applicant is requir$ to submit ! initial p$iatric /udy plan "u p>agraph 7#b77;,a744 7#c7 ,cl>ify+ applicability ,section #eje;,b7a77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77#a77 is am5d$ by add+ at ! end ! foll[+3 7,c7 ,rule ( con/ruction ,no application t is subject to ! requirem5ts ( subp>agraph 7,b7 %all be subject to ! requirem5ts ( subp>agraph 7,a71 & no application 7or supplem5t to an application7 t is subject to ! requirem5ts ( subp>agraph 7,a7 %all be subject to ! requirem5ts ( subp>agraph 7,b74 4 7#d7 ,con=m+ am5dm5ts ,section #eje;,b7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77 is am5d$-- 7,a7 9 p>agraph 7#c77;,c71 z r$esignat$ by p>agraph 7#a77;,a7 ( ?is subsection1 by /rik+ inve/igations describ$ 9 ?is p>agraph & ins]t+ inve/igations ref]r$ to 9 subp>agraph 7,a72 & 7,b7 9 p>agraph 7#c77;,d71 z r$esignat$ by p>agraph 7#a77;,a7 ( ?is subsection1 by /rik+ ! assessm5ts "u p>agraph 7#b77;,b7 & ins]t+ ! assessm5ts requir$ "u p>agraph 7#a77;,a74 7b7 ,guidance ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all-- 7#a7 n lat] ?an #ab mon?s aft] ! date ( enactm5t ( ?is ,act1 issue draft guidance on ! implem5tation ( ! am5dm5ts made by subsection 7a72 & 7#b7 n lat] ?an #ab mon?s aft] clos+ ! comm5t p]iod on su* draft guidance1 f9alize su* guidance4 7c7 ,applicability ,! am5dm5ts made by ?is section apply ) respect to any application "u section #eje7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 & any application "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a771 t is submitt$ on or aft] ! date t is #c ye>s aft] ! date ( enactm5t ( ?is ,act4 7d7 ,reports to ,congress 7#a7 ,secret>y ( ,heal? & ,human ,s]vices ,n lat] ?an #f ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report on ! ,secret>y's ef=ts1 9 coord9ation ) indu/ry1 to ensure implem5tation ( ! am5dm5ts made by subsection 7a74 7#b7 ,,gao /udy & report 7,a7 ,/udy ,n lat] ?an #h ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy ( ! effectiv5ess ( requir+ assessm5ts & inve/igations describ$ 9 section #eje;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4#cee;c71 z am5d$ by subsection 7a71 9 ! developm5t ( drugs & biological products = p$iatric canc] indications1 includ+ consid]ation ( any b5efits to1 or burd5s on1 p$iatric canc] drug developm5t4 7,b7 ,f9d+s ,n lat] ?an #aj ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report conta9+ ! f9d+s ( ! /udy conduct$ "u subp>agraph 7,a74 #hjb4 ,ensur+ completion ( p$iatric /udy requirem5ts 7a7 ,equal acc\ntability = p$iatric /udy requirem5ts ,section #eje;,b7d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7d77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ ,beg9n+ #bgj & ins]t+ ,noncompliance lett]4--,beg9n+ #bgj2 7#b7 9 p>agraph 7#b7-- 7,a7 by /rik+ ,! drug or & ins]t+ ,effect ( noncompliance4--,! drug or2 & 7,b7 by /rik+ 7except t ! drug or biological product %all n be subject to action "u section #cjc7 & ins]t+ 7except t ! drug or biological product %all be subject to action "u section #cjc only if su* p]son demon/rat$ a lack ( due dilig5ce 9 satisfy+ ! applicable requirem5t72 & 7#c7 by add+ at ! end ! foll[+3 7#c7 ,limitation ,! ,secret>y %all n issue en=cem5t actions "u section #cjc = failures "u ?is subsection 9 ! case ( a drug or biological product t is no long] m>ket$4 4 7b7 ,due dilig5ce ,section #eje;,b7d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7d771 z am5d$ by subsection 7a71 is fur!r am5d$ by add+ at ! end ! foll[+3 7#d7 ,due dilig5ce ,be=e ! ,secret>y may conclude t a p]son fail$ to submit or o!rwise meet a requirem5t z describ$ 9 ! matt] prec$+ p>agraph 7#a71 ! ,secret>y %all-- 7,a7 issue a noncompliance lett] pursuant to p>agraph 7#a72 7,b7 provide su* p]son ) a #de-;day p]iod beg9n+ on ! date ( receipt ( su* noncompliance lett] to respond 9 writ+ z set =? 9 su* p>agraph2 & 7,c7 aft] review+ su* writt5 response1 det]m9e :e!r ! p]son demon/rat$ a lack ( due dilig5ce 9 satisfy+ su* requirem5t4 4 7c7 ,con=m+ am5dm5ts ,section #cjc7;f77#d77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7;f77#d77;,a77 is am5d$ by /rik+ or #eje-a & ins]t+ #eje-a1 or #eje;,b4 7d7 ,transition rule ,! ,secret>y ( ,heal? & ,human ,s]vices may take en=cem5t action "u section #cjc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 only = failures describ$ 9 section #eje;,b7d7 ( su* ,act 7#ba ,u4,s4,c4 #cee;c7d77 t occur on or aft] ! date t is #ahj days aft] ! date ( enactm5t ( ?is ,act4 #hjc4 ,,fda report on ,,prea en=cem5t ,section #ejh7;b7 ( ! ,food & ,drug ,adm9i/ration ,safety & ,innovation ,act 7#ba ,u4,s4,c4 #cee;c-#a7;b77 is am5d$-- 7#a7 9 p>agraph 7#aa71 by /rik+ ! semicolon at ! end & ins]t+ 1 includ+ an evaluation ( compliance ) deadl9es provid$ = 9 def]rals & def]ral ext5sions22 7#b7 9 p>agraph 7#ae71 by /rik+ & at ! end2 7#c7 9 p>agraph 7#af71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7#d7 by add+ at ! end ! foll[+3 7#ag7 a li/+ ( p5alties1 settlem5ts1 or paym5ts "u section #cjc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7 = failure to comply ) requirem5ts "u su* section #eje;,b1 includ+1 = ea* p5alty1 settlem5t1 or paym5t1 ! "n ( ! drug1 ! sponsor !re(1 & ! am\nt ( ! p5alty1 settlem5t1 or paym5t impos$2 & 4 #hjd4 ,ext5sion ( au?ority to issue priority review v\*]s to enc\rage treatm5ts = r>e p$iatric diseases 7a7 ,ext5sion ,p>agraph 7#e7 ( section #ebi7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7b77 is am5d$ by /rik+ ,decemb] #bj1 #bjbd1 unless & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ ,septemb] #cj1 #bjbi44 7b7 ,us] fee paym5t ,section #ebi7;c77#d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7c77#d77 is am5d$ by /rik+ subp>agraph 7,a7 & ins]t+ ! foll[+3 7,a7 ,9 g5]al ,! priority review us] fee requir$ by ?is subsection %all be due ^u ! submission ( a human drug application "u section #eje7;b77#a7 or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act = :i* ! priority review v\*] is us$4 ,all o!r us] fees associat$ ) ! human drug application %all be due z requir$ by ! ,secret>y or "u applicable law4 4 7c7 ,,gao report on effectiv5ess ( r>e p$iatric disease priority v\*] aw>ds 9 inc5tiviz+ r>e p$iatric disease drug developm5t 7#a7 ,,gao /udy 7,a7 ,/udy ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy ( ! effectiv5ess ( aw>d+ r>e p$iatric disease priority v\*]s "u section #ebi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff71 z am5d$ by subsection 7a71 9 ! developm5t ( human drug products t treat or prev5t r>e p$iatric diseases 7z def9$ 9 su* section #ebi74 7,b7 ,cont5ts ( /udy ,9 conduct+ ! /udy "u subp>agraph 7,a71 ! ,comptroll] ,g5]al %all exam9e ! foll[+3 7i7 ,! indications = ea* drug or biological product t-- 7,i7 is ! subject ( a r>e p$iatric disease product application 7z def9$ 9 section #ebi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff77 = :i* a priority review v\*] 0 aw>d$2 & 7,,ii7 0 approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#db ,u4,s4,c4 #cee7 or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 7ii7 ,:e!r1 & to :at ext5t1 an unmet ne$ relat$ to ! treatm5t or prev5tion ( a r>e p$iatric disease 0 met ?r\gh ! approval or lic5sure ( su* a drug or biological product4 7iii7 ,! size ( ! company to :i* a priority review v\*] 0 aw>d$ "u section #ebi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7 = su* a drug or biological product4 7iv7 ,! value ( su* priority review v\*] if transf]r$4 7v7 ,id5tification ( ea* drug = :i* a priority review v\*] aw>d$ "u su* section #ebi 0 us$4 7vi7 ,! size ( ! company us+ ea* priority review v\*] aw>d$ "u su* section #ebi4 7vii7 ,! l5g? ( ! p]iod ( "t betwe5 ! date on :i* a priority review v\*] 0 aw>d$ "u su* section #ebi & ! date on :i* x 0 us$4 7viii7 ,:e!r1 & to :at ext5t1 an unmet ne$ relat$ to ! treatm5t or prev5tion ( a r>e p$iatric disease 0 met ?r\gh ! approval "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#db ,u4,s4,c4 #cee7 or lic5sure "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 ( a drug = :i* a priority review v\*] 0 us$4 7ix7 ,:e!r1 & to :at ext5t1 companies 7 motivat$ by ! availability ( priority review v\*]s "u section #ebi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7 to attempt to develop a drug = a r>e p$iatric disease4 7x7 ,:e!r1 & to :at ext5t1 p$iatric review v\*]s aw>d$ "u su* section 7 successful 9 /imulat+ developm5t & exp$it$ pati5t access to drug products = treatm5t or prev5tion ( a r>e p$iatric disease t w\ldn't o!rwise take place )\t ! inc5tive provid$ by su* v\*]s4 7xi7 ,! impact ( su* priority review v\*]s on ! workload1 review process1 & public heal? prioritization ef=ts ( ! ,food & ,drug ,adm9i/ration4 7xii7 ,any o!r inc5tives 9 ,f$]al law t exi/ = companies develop+ drugs or biological products describ$ 9 clause 7i74 7#b7 ,report on f9d+s ,n lat] ?an #e ye>s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report conta9+ ! f9d+s ( ! /udy conduct$ "u p>agraph 7#a74 #hje4 ,limitations on exclusive approval or lic5sure ( orphan drugs 7a7 ,9 g5]al ,section #ebg ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7 is am5d$-- 7#a7 9 subsection 7a71 9 ! matt] foll[+ p>agraph 7#b71 by /rik+ same disease or condition & ins]t+ same approv$ use or indication )9 su* r>e disease or condition2 7#b7 9 subsection 7b7-- 7,a7 9 ! matt] prec$+ p>agraph 7#a71 by /rik+ same r>e disease or condition & ins]t+ same approv$ use or indication = :i* su* #g-ye> p]iod applies to su* already approv$ or lic5s$ drug2 & 7,b7 9 p>agraph 7#a71 by ins]t+ 1 relat+ to ! approv$ use or indication1 aft] ! ne$s2 7#c7 9 subsection 7c77#a71 by /rik+ same r>e disease or condition z ! already approv$ drug & ins]t+ same use or indication = :i* ! already approv$ or lic5s$ drug 0 approv$ or lic5s$2 & 7#d7 by add+ at ! end ! foll[+3 7f7 ,approv$ use or indication def9$ ,9 ?is section1 ! t]m approv$ use or indication means ! use or indication approv$ "u section #eje ( ?is ,act or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act = a drug designat$ "u section #ebf = a r>e disease or condition4 4 7b7 ,application ( am5dm5ts ,! am5dm5ts made by subsection 7a7 %all apply ) respect to any drug designat$ "u section #ebf ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb71 reg>dless ( ! date on :i* ! drug 0 s designat$1 & reg>dless ( ! date on :i* ! drug 0 approv$ "u section #eje ( su* ,act 7#ba ,u4,s4,c4 #cee7 or lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 ,b ,unit$ ,/ates-,abraham ,accords ,coop]ation & ,security #haa4 ,e/abli%m5t ( ,abraham ,accords ,(fice )9 ,food & ,drug ,adm9i/ration 7a7 ,9 g5]al ,*apt] ,x ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cia et seq47 is am5d$ by add+ at ! end ! foll[+3 #ajae4 ,abraham ,accords ,(fice 7a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all e/abli% )9 ! ,food & ,drug ,adm9i/ration an (fice1 to be kn[n z ! ,abraham ,accords ,(fice1 to be head$ by a director4 7b7 ,(fice ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all-- 7#a7 9 consultation ) ! gov]nm5ts ( ,abraham ,accords c\ntries1 z well z appropriate ,unit$ ,/ates ,gov]nm5t diplomatic & security p]sonnel-- 7,a7 select ! location ( ! ,abraham ,accords ,(fice 9 an ,abraham ,accords c\ntry2 & 7,b7 e/abli% su* (fice2 & 7#b7 assign to su* (fice su* p]sonnel ( ! ,food & ,drug ,adm9i/ration z ! ,secret>y det]m9es necess>y to c>ry out ! functions ( su* (fice4 7c7 ,duties ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,abraham ,accords ,(fice1 %all-- 7#a7 aft] ! ,abraham ,accords ,(fice is e/abli%$-- 7,a7 z "p ( ! ,food & ,drug ,adm9i/ration's "w to /r5g!n ! int]national ov]sight ( regulat$ commodities1 provide te*nical assi/ance to regulatory p>tn]s 9 ,abraham ,accords c\ntries on /r5g!n+ regulatory ov]sight & conv]g+ regulatory requirem5ts = ! ov]sight ( regulat$ products1 includ+ good manufactur+ practices & o!r issues relevant to manufactur+ m$ical products t are regulat$ by ! ,food & ,drug ,adm9i/ration2 & 7,b7 facilitate int]actions betwe5 ! ,food & ,drug ,adm9i/ration & int]e/$ p>ties 9 ,abraham ,accords c\ntries1 includ+ by %>+ relevant in=mation reg>d+ ,unit$ ,/ates regulatory pa?ways ) su* p>ties1 & facilitate fe$back on ! rese>*1 developm5t1 & manufactur+ ( products regulat$ 9 accordance ) ?is ,act2 & 7#b7 c>ry out o!r functions & activities z ! ,secret>y det]m9es to be necess>y to c>ry out ?is section4 7d7 ,abraham ,accords c\ntry def9$ ,9 ?is section1 ! t]m ,abraham ,accords c\ntry means a c\ntry id5tifi$ by ! ,dep>tm5t ( ,/ate z hav+ sign$ ! ,abraham ,accords ,decl>ation4 7e7 ,national security ,no?+ 9 ?is section %all be con/ru$ to require any action inconsi/5t ) a national security recomm5dation provid$ by ! ,f$]al ,gov]nm5t4 4 7b7 ,report to ,congress 7#a7 ,9 g5]al ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all submit to ! ,congress a report on ! ,abraham ,accords ,(fice1 includ+-- 7,a7 an evaluation ( h[ ! ,(fice has advanc$ progress t[>d con=mance ) ,food & ,drug ,adm9i/ration regulatory requirem5ts by manufactur]s 9 ! ,abraham ,accords c\ntries2 7,b7 a num]ical c\nt ( p>ties t ! ,(fice has help$ facilitate int]actions or fe$back pursuant to section #ajae7;c77#a77;,b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by subsection 7a772 7,c7 a summ>y ( te*nical assi/ance provid$ to regulatory p>tn]s 9 ,abraham ,accords c\ntries pursuant to subp>agraph 7,a7 ( su* section #ajae7;c77#a72 & 7,d7 recomm5dations = increas+ & improv+ coord9ation betwe5 ! ,food & ,drug ,adm9i/ration & entities 9 ,abraham ,accords c\ntries4 7#b7 ,abraham ,accords c\ntry def9$ ,9 ?is subsection1 ! t]m ,abraham ,accords c\ntry has ! mean+ giv5 su* t]m 9 section #ajae7;d7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7z add$ by subsection 7a774 ,,ix ,l[]+ prescription drug co/s #ija4 ,ov]sight ( ph>macy b5efit managem5t s]vices 7a7 ,public ,heal? ,s]vice ,act ,title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg et seq47 is am5d$-- 7#a7 9 "p ,d 7#db ,u4,s4,c4 #cjj;gg-#aaa et seq471 by add+ at ! end ! foll[+ new section3 #bgii;,a-#aa4 ,ov]sight ( entities t provide ph>macy b5efit managem5t s]vices 7a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ! date t is #cj mon?s aft] ! date ( enactm5t ( ?is section 7ref]r$ to 9 ?is subsection & subsection 7b7 z ! effective date71 a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan or issu]1 %all n ent] into a contract1 includ+ an ext5sion or r5ewal ( a contract1 ent]$ into on or aft] ! effective date1 ) an applicable entity unless su* applicable entity agrees to-- 7#a7 n limit or delay ! disclosure ( in=mation to ! gr\p heal? plan 7includ+ su* a plan (f]$ ?r\gh a heal? insurance issu]7 9 su* a mann] t prev5ts an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age f mak+ ! reports describ$ 9 subsection 7b72 & 7#b7 provide ! entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or heal? insurance issu] relevant in=mation necess>y to make ! reports describ$ 9 subsection 7b74 7b7 ,reports 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ! effective date1 9 ! case ( any contract betwe5 a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p heal? insurance cov]age (f]$ 9 connection ) su* a plan & an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* plan or issu]1 includ+ an ext5sion or r5ewal ( su* a contract1 ent]$ into on or aft] ! effective date1 ! entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a gr\p heal? plan or heal? insurance issu]1 n less frequ5tly ?an e #f mon?s 7or1 at ! reque/ ( a gr\p heal? plan1 n less frequ5tly ?an qu>t]ly1 & "u ! same conditions1 t]ms1 & co/ ( ! semiannual report "u ?is subsection71 %all submit to ! gr\p heal? plan a report 9 accordance ) ?is section4 ,ea* su* report %all be made available to su* gr\p heal? plan 9 pla9 language1 9 a ma*9e-readable =mat1 & z ! ,secret>y may det]m9e1 o!r =mats4 ,ea* su* report %all include ! in=mation describ$ 9 p>agraph 7#b74 7#b7 ,in=mation describ$ ,= purposes ( p>agraph 7#a71 ! in=mation describ$ 9 ?is p>agraph is1 ) respect to drugs cov]$ by a gr\p heal? plan or gr\p heal? insurance cov]age (f]$ by a heal? insurance issu] 9 connection ) a gr\p heal? plan dur+ ea* report+ p]iod-- 7,a7 9 ! case ( a gr\p heal? plan t is (f]$ by a specifi$ l>ge employ] or t is a specifi$ l>ge plan1 & is n (f]$ z heal? insurance cov]age1 or 9 ! case ( heal? insurance cov]age = :i* ! election "u p>agraph 7#c7 is made = ! applicable report+ p]iod-- 7i7 a li/ ( drugs = :i* a claim 0 fil$ &1 ) respect to ea* su* drug on su* li/-- 7,i7 ! contract$ comp5sation paid by ! gr\p heal? plan or heal? insurance issu] = ea* cov]$ drug 7id5tifi$ by ! ,national ,drug ,code7 to ! entity provid+ ph>macy b5efit managem5t s]vices or o!r applicable entity on behalf ( ! gr\p heal? plan or heal? insurance issu]2 7,,ii7 ! contract$ comp5sation paid to ! ph>macy1 by any entity provid+ ph>macy b5efit managem5t s]vices or o!r applicable entity on behalf ( ! gr\p heal? plan or heal? insurance issu]1 = ea* cov]$ drug 7id5tifi$ by ! ,national ,drug ,code72 7,,iii7 = ea* su* claim1 ! diff]5ce betwe5 ! am\nt paid "u subclause 7,i7 & ! am\nt paid "u subclause 7,,ii72 7,,iv7 ! propriet>y "n1 e/abli%$ "n or prop] "n1 & ! ,national ,drug ,code2 7,v7 = ea* claim = ! drug 7includ+ orig9al prescriptions & refills7 & = ea* dosage unit ( ! drug = :i* a claim 0 fil$1 ! type ( disp5s+ *annel us$ to furni% ! drug1 includ+ retail1 mail ord]1 or specialty ph>macy2 7,,vi7 ) respect to ea* drug disp5s$1 = ea* type ( disp5s+ *annel 7includ+ retail1 mail ord]1 or specialty ph>macy7-- 7aa7 :e!r su* drug is a br& "n drug or a g5]ic drug1 &-- 7,,aa7 9 ! case ( a br& "n drug1 ! :olesale acquisition co/1 li/$ z co/ p] days supply & co/ p] dosage unit1 on ! date su* drug 0 disp5s$2 & 7,,bb7 9 ! case ( a g5]ic drug1 ! av]age :olesale price1 li/$ z co/ p] days supply & co/ p] dosage unit1 on ! date su* drug 0 disp5s$2 & 7bb7 ! total numb] (-- 7,,aa7 prescription claims 7includ+ orig9al prescriptions & refills72 7,,bb7 p>ticipants & b5efici>ies = :om a claim = su* drug 0 fil$ ?r\gh ! applicable disp5s+ *annel2 7,,cc7 dosage units & dosage units p] fill ( su* drug2 & 7,,dd7 days supply ( su* drug p] fill2 7,,vii7 ! net price p] c\rse ( treatm5t or s+le fill1 su* z a #cj-;day supply or #ij-;day supply to ! plan or cov]age aft] rebates1 fees1 alt]native disc\nts1 or o!r remun]ation receiv$ f applicable entities2 7,,viii7 ! total am\nt ( out-(-pocket sp5d+ by p>ticipants & b5efici>ies on su* drug1 includ+ sp5d+ ?r\gh copaym5ts1 co9surance1 & d$uctibles1 b n includ+ any am\nts sp5t by p>ticipants & b5efici>ies on drugs n cov]$ "u ! plan or cov]age1 or = :i* no claim is submitt$ "u ! plan or cov]age2 7,,ix7 ! total net sp5d+ on ! drug2 7,x7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! plan or issu] f any applicable entity 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation2 7,,xi7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! entity provid+ ph>macy b5efit managem5t s]vices1 f applicable entities1 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation f su* entities-- 7aa7 = claims incurr$ dur+ ! report+ p]iod2 & 7bb7 t is relat$ to utilization ( su* drug or sp5d+ on su* drug2 & 7,,xii7 to ! ext5t feasible1 in=mation on ! total am\nt ( remun]ation = su* drug1 includ+ copaym5t assi/ance doll>s paid1 copaym5t c>ds appli$1 or o!r disc\nts provid$ by ea* drug manufactur] 7or entity adm9i/]+ copaym5t assi/ance on behalf ( su* drug manufactur]71 to ! p>ticipants & b5efici>ies enroll$ 9 su* plan or cov]age2 7ii7 a li/ ( ea* !rapeutic class 7z def9$ by ! ,secret>y7 = :i* a claim 0 fil$ "u ! gr\p heal? plan or heal? insurance cov]age dur+ ! report+ p]iod1 &1 ) respect to ea* su* !rapeutic class-- 7,i7 ! total gross sp5d+ on drugs 9 su* class be=e rebates1 price concessions1 alt]native disc\nts1 or o!r remun]ation f applicable entities2 7,,ii7 ! net sp5d+ 9 su* class aft] su* rebates1 price concessions1 alt]native disc\nts1 or o!r remun]ation f applicable entities2 7,,iii7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! entity provid+ ph>macy b5efit managem5t s]vices1 f applicable entities1 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation f su* entities-- 7aa7 = claims incurr$ dur+ ! report+ p]iod2 & 7bb7 t is relat$ to utilization ( drugs or drug sp5d+2 7,,iv7 ! av]age net sp5d+ p] #cj-;day supply & p] #ij-;day supply by ! plan or by ! issu] ) respect to su* cov]age & its p>ticipants & b5efici>ies1 among all drugs )9 ! !rapeutic class = :i* a claim 0 fil$ dur+ ! report+ p]iod2 7,v7 ! numb] ( p>ticipants & b5efici>ies :o fill$ a prescription = a drug 9 su* class1 includ+ ! ,national ,drug ,code = ea* su* drug2 7,,vi7 if applicable1 a description ( ! =mul>y ti]s & utilization me*anisms 7su* z prior au?orization or /ep !rapy7 employ$ = drugs 9 t class2 & 7,,vii7 ! total out-(-pocket sp5d+ "u ! plan or cov]age by p>ticipants & b5efici>ies1 includ+ sp5d+ ?r\gh copaym5ts1 co9surance1 & d$uctibles1 b n includ+ any am\nts sp5t by p>ticipants & b5efici>ies on drugs n cov]$ "u ! plan or cov]age or = :i* no claim is submitt$ "u ! plan or cov]age2 7iii7 ) respect to any drug = :i* gross sp5d+ "u ! gr\p heal? plan or heal? insurance cov]age exce$$ #aj1jjj dur+ ! report+ p]iod or1 9 ! case t gross sp5d+ "u ! gr\p heal? plan or cov]age exce$$ #aj1jjj dur+ ! report+ p]iod ) respect to few] ?an #ej drugs1 ) respect to ! #ej prescription drugs ) ! highe/ sp5d+ dur+ ! report+ p]iod-- 7,i7 a li/ ( all o!r drugs 9 ! same !rapeutic class z su* drug2 7,,ii7 if applicable1 ! rationale = ! =mul>y placem5t ( su* drug 9 t !rapeutic category or class1 select$ f a li/ ( /&>d rationales e/abli%$ by ! ,secret>y1 9 consultation ) /akehold]s2 & 7,,iii7 any *ange 9 =mul>y placem5t comp>$ to ! prior plan ye>2 & 7iv7 9 ! case t su* plan or issu] 7or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* plan or issu]7 has an affiliat$ ph>macy or ph>macy "u common own]%ip1 includ+ m&atory mail & specialty home deliv]y programs1 retail & mail auto-refill programs1 & co/ %>+ assi/ance inc5tives fund$ by an entity provid+ ph>macy b5efit s]vices-- 7,i7 an explanation ( any b5efit design p>amet]s t enc\rage or require p>ticipants & b5efici>ies 9 ! plan or cov]age to fill prescriptions at mail ord]1 specialty1 or retail ph>macies2 7,,ii7 ! p]c5tage ( total prescriptions disp5s$ by su* ph>macies to p>ticipants or b5efici>ies 9 su* plan or cov]age2 & 7,,iii7 a li/ ( all drugs disp5s$ by su* ph>macies to p>ticipants or b5efici>ies enroll$ 9 su* plan or cov]age1 &1 ) respect to ea* drug disp5s$-- 7aa7 ! am\nt *>g$1 p] dosage unit1 p] #cj-;day supply1 or p] #ij-;day supply 7z applicable7 to ! plan or issu]1 & to p>ticipants & b5efici>ies2 7bb7 ! m$ian am\nt *>g$ to su* plan or issu]1 & ! int]qu>tile range ( ! co/s1 p] dosage unit1 p] #cj-;day supply1 & p] #ij-;day supply1 includ+ am\nts paid by ! p>ticipants & b5efici>ies1 :5 ! same drug is disp5s$ by o!r ph>macies t are n affiliat$ ) or "u common own]%ip ) ! entity & t are includ$ 9 ! ph>macy network ( su* plan or cov]age2 7cc7 ! l[e/ co/ p] dosage unit1 p] #cj-;day supply & p] #ij-;day supply1 = ea* su* drug1 includ+ am\nts *>g$ to ! plan or cov]age & to p>ticipants & b5efici>ies1 t is available f any ph>macy includ$ 9 ! network ( su* plan or cov]age2 & 7dd7 ! net acquisition co/ p] dosage unit1 p] #cj-;day supply1 & p] #ij-;day supply1 if su* drug is subject to a maximum price disc\nt2 & 7,b7 ) respect to any gr\p heal? plan1 includ+ gr\p heal? insurance cov]age (f]$ 9 connection ) su* a plan1 reg>dless ( :e!r ! plan or cov]age is (f]$ by a specifi$ l>ge employ] or :e!r x is a specifi$ l>ge plan-- 7i7 a summ>y docum5t = ! gr\p heal? plan t includes su* in=mation describ$ 9 clauses 7i7 ?r\gh 7iv7 ( subp>agraph 7,a71 z specifi$ by ! ,secret>y ?r\gh guidance1 program in/ruction1 or o!rwise 7) no requirem5t ( notice & comm5t rulemak+71 t ! ,secret>y det]m9es useful to gr\p heal? plans = purposes ( select+ ph>macy b5efit managem5t s]vices1 su* z an e/imat$ net price to gr\p heal? plan & p>ticipant or b5efici>y1 a co/ p] claim1 ! fee /ructure or reimbursem5t model1 & e/imat$ co/ p] p>ticipant or b5efici>y2 7ii7 a summ>y docum5t = plans & issu]s to provide to p>ticipants & b5efici>ies1 :i* %all be made available to p>ticipants or b5efici>ies ^u reque/ to _! gr\p heal? plan 7includ+ 9 ! case ( gr\p heal? insurance cov]age (f]$ 9 connection ) su* a plan71 t-- 7,i7 conta9s su* in=mation describ$ 9 clauses 7iii71 7iv71 7v71 & 7vi71 z applicable1 z specifi$ by ! ,secret>y ?r\gh guidance1 program in/ruction1 or o!rwise 7) no requirem5t ( notice & comm5t rulemak+7 t ! ,secret>y det]m9es useful to p>ticipants or b5efici>ies 9 bett] und]/&+ ! plan or cov]age or b5efits "u su* plan or cov]age2 7,,ii7 conta9s only aggregate in=mation2 & 7,,iii7 /ates t p>ticipants & b5efici>ies may reque/ specific1 claims-level in=mation requir$ to be furni%$ "u subsection 7c7 f ! gr\p heal? plan or heal? insurance issu]2 & 7iii7 ) respect to drugs cov]$ by su* plan or cov]age dur+ su* report+ p]iod-- 7,i7 ! total net sp5d+ by ! plan or cov]age = all su* drugs2 7,,ii7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! plan or issu] f any applicable entity 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation2 & 7,,iii7 to ! ext5t feasible1 in=mation on ! total am\nt ( remun]ation = su* drugs1 includ+ copaym5t assi/ance doll>s paid1 copaym5t c>ds appli$1 or o!r disc\nts provid$ by ea* drug manufactur] 7or entity adm9i/]+ copaym5t assi/ance on behalf ( su* drug manufactur]7 to p>ticipants & b5efici>ies2 7iv7 am\nts paid directly or indirectly 9 rebates1 fees1 or any o!r type ( comp5sation 7z def9$ 9 section #djh7;b77#b77;,b77ii77dd77,,aa7 ( ! ,employee ,retirem5t ,income ,security ,act7 to brok]age firms1 brok]s1 consultants1 advisors1 or any o!r individual or firm1 =-- 7,i7 ! ref]ral ( ! gr\p heal? plan's or heal? insurance issu]'s bus9ess to an entity provid+ ph>macy b5efit managem5t s]vices1 includ+ ! id5tity ( ! recipi5t ( su* am\nts2 7,,ii7 consid]ation ( ! entity provid+ ph>macy b5efit managem5t s]vices by ! gr\p heal? plan or heal? insurance issu]2 or 7,,iii7 ! ret5tion ( ! entity by ! gr\p heal? plan or heal? insurance issu]2 7v7 an explanation ( any b5efit design p>amet]s t enc\rage or require p>ticipants & b5efici>ies 9 su* plan or cov]age to fill prescriptions at mail ord]1 specialty1 or retail ph>macies t are affiliat$ ) or "u common own]%ip ) ! entity provid+ ph>macy b5efit managem5t s]vices "u su* plan or cov]age1 includ+ m&atory mail & specialty home deliv]y programs1 retail & mail auto-refill programs1 & co/-%>+ assi/ance inc5tives directly or indirectly fund$ by su* entity2 & 7vi7 total gross sp5d+ on all drugs "u ! plan or cov]age dur+ ! report+ p]iod4 7#c7 ,opt-9 = gr\p heal? insurance cov]age (f]$ by a specifi$ l>ge employ] or t is a specifi$ l>ge plan ,9 ! case ( gr\p heal? insurance cov]age (f]$ 9 connection ) a gr\p heal? plan t is (f]$ by a specifi$ l>ge employ] or is a specifi$ l>ge plan1 su* gr\p heal? plan may1 on an annual basis1 = plan ye>s beg9n+ on or aft] ! date t is #cj mon?s aft] ! date ( enactm5t ( ?is section1 elect to require an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( ! heal? insurance issu] to submit to su* gr\p heal? plan a report t includes all ( ! in=mation describ$ 9 p>agraph 7#b77;,a71 9 addition to ! in=mation describ$ 9 p>agraph 7#b77;,b74 7#d7 ,privacy requirem5ts 7,a7 ,9 g5]al ,an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all report in=mation "u p>agraph 7#a7 9 a mann] consi/5t ) ! privacy regulations promulgat$ "u section #acdjb7;a7 ( ! ,heal? ,in=mation ,te*nology = ,economic & ,cl9ical ,heal? ,act & consi/5t ) ! privacy regulations promulgat$ "u ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 9 "p #afj & subp>ts ,a & ,e ( "p #afd ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations7 7ref]r$ to 9 ?is p>agraph z ! ,,hipaa privacy regulations7 & %all re/rict ! use & disclosure ( su* in=mation accord+ to su* privacy regulations & su* ,,hipaa privacy regulations4 7,b7 ,additional requirem5ts 7i7 ,9 g5]al ,an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age t submits a report "u p>agraph 7#a7 %all ensure t su* report conta9s only summ>y heal? in=mation1 z def9$ 9 section #afd4ejd7;a7 ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7ii7 ,re/rictions ,9 c>ry+ out ?is subsection1 a gr\p heal? plan %all comply ) section #afd4ejd7;f7 ( title #de1 ,code ( ,f$]al ,regulations 7or a successor regulation71 & a plan sponsor %all act 9 accordance ) ! t]ms ( ! agreem5t describ$ 9 su* section4 7,c7 ,rule ( con/ruction 7i7 ,no?+ 9 ?is section %all be con/ru$ to modify ! requirem5ts = ! creation1 receipt1 ma9t5ance1 or transmission ( protect$ heal? in=mation "u ! ,,hipaa privacy regulations4 7ii7 ,no?+ 9 ?is section %all be con/ru$ to affect ! application ( any ,f$]al or ,/ate privacy or civil rights law1 includ+ ! ,,hipaa privacy regulations1 ! ,g5etic ,in=mation ,nondiscrim9ation ,act ( #bjjh 7,public ,law #aaj-bcc7 7includ+ ! am5dm5ts made by su* ,act71 ! ,am]icans ) ,disabilities ,act ( #aiij 7#db ,u4,s4,c4 #abaja et seq471 section #ejd ( ! ,rehabilitation ,act ( #aigc 7#bi ,u4,s4,c4 #gid71 section #aeeg ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahaaf71 title ,,vi ( ! ,civil ,rights ,act ( #aifd 7#db ,u4,s4,c4 #bjjj;d71 & title ,,vii ( ! ,civil ,rights ,act ( #aifd 7#db ,u4,s4,c4 #bjjj;e74 7,d7 ,writt5 notice ,ea* plan ye>1 gr\p heal? plans1 includ+ ) respect to gr\p heal? insurance cov]age (f]$ 9 connection ) a gr\p heal? plan1 %all provide to ea* p>ticipant or b5efici>y writt5 notice in=m+ ! p>ticipant or b5efici>y ( ! requirem5t = entities provid+ ph>macy b5efit managem5t s]vices on behalf ( ! gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age to submit reports to gr\p heal? plans "u p>agraph 7#a71 z applicable1 :i* may include incorporat+ su* notification 9 plan docum5ts provid$ to ! p>ticipant or b5efici>y1 or provid+ individual notification4 7,e7 ,limitation to bus9ess associates ,a gr\p heal? plan receiv+ a report "u p>agraph 7#a7 may disclose su* in=mation only to ! entity f :i* ! report 0 receiv$ or to t entity's bus9ess associates z def9$ 9 section #afj4ajc ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations7 or z p]mitt$ by ! ,,hipaa privacy regulations4 7,f7 ,cl>ification reg>d+ public disclosure ( in=mation ,no?+ 9 ?is section %all prev5t an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 f plac+ reasonable re/rictions on ! public disclosure ( ! in=mation conta9$ 9 a report describ$ 9 p>agraph 7#a71 except t su* plan1 issu]1 or entity may n-- 7i7 re/rict disclosure ( su* report to ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,dep>tm5t ( ,labor1 or ! ,dep>tm5t ( ! ,treasury2 or 7ii7 prev5t disclosure = ! purposes ( subsection 7c71 or any o!r public disclosure requirem5t "u ?is section4 7,g7 ,limit$ =m ( report ,! ,secret>y %all def9e ?r\gh rulemak+ a limit$ =m ( ! report "u p>agraph 7#a7 requir$ ) respect to any gr\p heal? plan e/abli%$ by a plan sponsor t is1 or is affiliat$ )1 a drug manufactur]1 drug :olesal]1 or o!r direct p>ticipant 9 ! drug supply *a91 9 ord] to prev5t anti-competitive behavior4 7#e7 ,/&>d =mat & regulations 7,a7 ,9 g5]al ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all specify ?r\gh rulemak+ a /&>d =mat = entities provid+ ph>macy b5efit managem5t s]vices on behalf ( gr\p heal? plans & heal? insurance issu]s (f]+ gr\p heal? insurance cov]age1 to submit reports requir$ "u p>agraph 7#a74 7,b7 ,additional regulations ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all1 ?r\gh rulemak+1 promulgate any o!r f9al regulations necess>y to implem5t ! requirem5ts ( ?is section4 ,9 promulgat+ su* regulations1 ! ,secret>y %all1 to ! ext5t practicable1 align ! report+ requirem5ts "u ?is section ) ! report+ requirem5ts "u section #bgii;,a-#aj4 7c7 ,requirem5t ,to provide in=mation to p>ticipants or b5efici>ies ,a gr\p heal? plan1 includ+ ) respect to gr\p heal? insurance cov]age (f]$ 9 connection ) a gr\p heal? plan1 ^u reque/ ( a p>ticipant or b5efici>y1 %all provide to su* p>ticipant or b5efici>y-- 7#a7 ! summ>y docum5t describ$ 9 subsection 7b77#b77;,b77ii72 & 7#b7 ! in=mation describ$ 9 subsection 7b77#b77;,a77i77,,iii7 ) respect to a claim made by or on behalf ( su* p>ticipant or b5efici>y4 7d7 ,en=cem5t 7#a7 ,9 g5]al ,! ,secret>y %all en=ce ?is section4 ,! en=cem5t au?ority "u ?is subsection %all apply only ) respect to gr\p heal? plans 7includ+ gr\p heal? insurance cov]age (f]$ 9 connection ) su* a plan7 to :i* ! requirem5ts ( subp>ts ,i & ,,ii ( "p ,a & "p ,d apply 9 accordance ) section #bgbb1 & ) respect to entities provid+ ph>macy b5efit managem5t s]vices on behalf ( su* plans & applicable entities provid+ s]vices on behalf ( su* plans4 7#b7 ,failure to provide in=mation ,a gr\p heal? plan1 a heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan or issu]1 or an applicable entity provid+ s]vices on behalf ( su* a plan or issu] t violates subsection 7a72 an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan or issu] t fails to provide ! in=mation requir$ "u subsection 7b72 or a gr\p heal? plan t fails to provide ! in=mation requir$ "u subsection 7c71 %all be subject to a civil monet>y p5alty 9 ! am\nt ( #aj1jjj = ea* day dur+ :i* su* violation cont9ues or su* in=mation is n disclos$ or report$4 7#c7 ,false in=mation ,a heal? insurance issu]1 an entity provid+ ph>macy b5efit managem5t s]vices1 or a ?ird p>ty adm9i/rator provid+ s]vices on behalf ( su* issu] (f]$ by a heal? insurance issu] t kn[+ly provides false in=mation "u ?is section %all be subject to a civil monet>y p5alty 9 an am\nt n to exce$ #ajj1jjj = ea* item ( false in=mation4 ,su* civil monet>y p5alty %all be 9 addition to o!r p5alties z may be prescrib$ by law4 7#d7 ,proc$ure ,! provisions ( section #aabh;,a ( ! ,social ,security ,act1 o!r ?an subsections 7a7 & 7b7 & ! fir/ s5t5ce ( subsection 7c77#a7 ( su* section %all apply to civil monet>y p5alties "u ?is subsection 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u su* section4 7#e7 ,waiv]s ,! ,secret>y may waive p5alties "u p>agraph 7#b71 or ext5d ! p]iod ( "t = compliance ) a requirem5t ( ?is section1 = an entity 9 violation ( ?is section t has made a good-fai? ef=t to comply ) ! requirem5ts 9 ?is section4 7e7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to p]mit a heal? insurance issu]1 gr\p heal? plan1 entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or heal? insurance issu]1 or o!r entity to re/rict disclosure to1 or o!rwise limit ! access (1 ! ,secret>y to a report describ$ 9 subsection 7b77#a7 or in=mation relat$ to compliance ) subsections 7a71 7b71 7c71 or 7d7 by su* issu]1 plan1 or entity4 7f7 ,def9itions ,9 ?is section3 7#a7 ,applicable entity ,! t]m applicable entity means-- 7,a7 an applicable gr\p pur*as+ organization1 drug manufactur]1 di/ributor1 :olesal]1 rebate aggregator 7or o!r pur*as+ entity design$ to aggregate rebates71 or associat$ ?ird p>ty2 7,b7 any subsidi>y1 p>5t1 affiliate1 or subcontractor ( a gr\p heal? plan1 heal? insurance issu]1 entity t provides ph>macy b5efit managem5t s]vices on behalf ( su* a plan or issu]1 or any entity describ$ 9 subp>agraph 7,a72 or 7,c7 su* o!r entity z ! ,secret>y may specify ?r\gh rulemak+4 7#b7 ,applicable gr\p pur*as+ organization ,! t]m applicable gr\p pur*as+ organization means a gr\p pur*as+ organization t is affiliat$ ) or "u common own]%ip ) an entity provid+ ph>macy b5efit managem5t s]vices4 7#c7 ,contract$ comp5sation ,! t]m contract$ comp5sation means ! sum ( any +r$i5t co/ & disp5s+ fee = a drug 7inclusive ( ! out-(-pocket co/s to ! p>ticipant or b5efici>y71 or ano!r analog\s comp5sation /ructure t ! ,secret>y may specify ?r\gh regulations4 7#d7 ,gross sp5d+ ,! t]m gross sp5d+1 ) respect to prescription drug b5efits "u a gr\p heal? plan or heal? insurance cov]age1 means ! am\nt sp5t by a gr\p heal? plan or heal? insurance issu] on prescription drug b5efits1 calculat$ be=e ! application ( rebates1 fees1 alt]native disc\nts1 or o!r remun]ation4 7#e7 ,net sp5d+ ,! t]m net sp5d+1 ) respect to prescription drug b5efits "u a gr\p heal? plan or heal? insurance cov]age1 means ! am\nt sp5t by a gr\p heal? plan or heal? insurance issu] on prescription drug b5efits1 calculat$ aft] ! application ( rebates1 fees1 alt]native disc\nts1 or o!r remun]ation4 7#f7 ,plan sponsor ,! t]m plan sponsor has ! mean+ giv5 su* t]m 9 section #c7af77;,b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd4 7#g7 ,remun]ation ,! t]m remun]ation has ! mean+ giv5 su* t]m by ! ,secret>y ?r\gh rulemak+1 :i* %all be reevaluat$ by ! ,secret>y e #e ye>s4 7#h7 ,specifi$ l>ge employ] ,! t]m specifi$ l>ge employ] means1 9 connection ) a gr\p heal? plan 7includ+ gr\p heal? insurance cov]age (f]$ 9 connection ) su* a plan7 e/abli%$ or ma9ta9$ by a s+le employ]1 ) respect to a cal5d> ye> or a plan ye>1 z applicable1 an employ] :o employ$ an av]age ( at lea/ #ajj employees on bus9ess days dur+ ! prec$+ cal5d> ye> or plan ye> & :o employs at lea/ #a employee on ! fir/ day ( ! cal5d> ye> or plan ye>4 7#i7 ,specifi$ l>ge plan ,! t]m specifi$ l>ge plan means a gr\p heal? plan 7includ+ gr\p heal? insurance cov]age (f]$ 9 connection ) su* a plan7 e/abli%$ or ma9ta9$ by a plan sponsor describ$ 9 clause 7ii7 or 7iii7 ( section #c7af77;,b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd t _h an av]age ( at lea/ #ajj p>ticipants on bus9ess days dur+ ! prec$+ cal5d> ye> or plan ye>1 z applicable4 7#aj7 ,:olesale acquisition co/ ,! t]m :olesale acquisition co/ has ! mean+ giv5 su* t]m 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act4 2 & 7#b7 9 section #bgbc 7#db ,u4,s4,c4 #cjj;gg-#bb7-- 7,a7 9 subsection 7a7-- 7i7 9 p>agraph 7#a71 by ins]t+ 7o!r ?an section #bgii;,a-#aa7 aft] "p ,d2 & 7ii7 9 p>agraph 7#b71 by ins]t+ 7o!r ?an section #bgii;,a-#aa7 aft] "p ,d2 & 7,b7 9 subsection 7b7-- 7i7 9 p>agraph 7#a71 by ins]t+ 7o!r ?an section #bgii;,a-#aa7 aft] "p ,d2 7ii7 9 p>agraph 7#b77;,a71 by ins]t+ 7o!r ?an section #bgii;,a-#aa7 aft] "p ,d2 & 7iii7 9 p>agraph 7#b77;,c77ii71 by ins]t+ 7o!r ?an section #bgii;,a-#aa7 aft] "p ,d4 7b7 ,employee ,retirem5t ,income ,security ,act ( #aigd 7#a7 ,9 g5]al ,subtitle ,b ( title ,i ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #ajba et seq47 is am5d$-- 7,a7 9 subp>t ,b ( "p #g 7#bi ,u4,s4,c4 #aahe et seq471 by add+ at ! end ! foll[+3 #gbf4 ,ov]sight ( entities t provide ph>macy b5efit managem5t s]vices 7a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ! date t is #cj mon?s aft] ! date ( enactm5t ( ?is section 7ref]r$ to 9 ?is subsection & subsection 7b7 z ! effective date71 a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan or issu]1 %all n ent] into a contract1 includ+ an ext5sion or r5ewal ( a contract1 ent]$ into on or aft] ! effective date1 ) an applicable entity unless su* applicable entity agrees to-- 7#a7 n limit or delay ! disclosure ( in=mation to ! gr\p heal? plan 7includ+ su* a plan (f]$ ?r\gh a heal? insurance issu]7 9 su* a mann] t prev5ts an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age f mak+ ! reports describ$ 9 subsection 7b72 & 7#b7 provide ! entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or heal? insurance issu] relevant in=mation necess>y to make ! reports describ$ 9 subsection 7b74 7b7 ,reports 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ! effective date1 9 ! case ( any contract betwe5 a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p heal? insurance cov]age (f]$ 9 connection ) su* a plan & an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* plan or issu]1 includ+ an ext5sion or r5ewal ( su* a contract1 ent]$ into on or aft] ! effective date1 ! entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a gr\p heal? plan or heal? insurance issu]1 n less frequ5tly ?an e #f mon?s 7or1 at ! reque/ ( a gr\p heal? plan1 n less frequ5tly ?an qu>t]ly1 & "u ! same conditions1 t]ms1 & co/ ( ! semiannual report "u ?is subsection71 %all submit to ! gr\p heal? plan a report 9 accordance ) ?is section4 ,ea* su* report %all be made available to su* gr\p heal? plan 9 pla9 language1 9 a ma*9e-readable =mat1 & z ! ,secret>y may det]m9e1 o!r =mats4 ,ea* su* report %all include ! in=mation describ$ 9 p>agraph 7#b74 7#b7 ,in=mation describ$ ,= purposes ( p>agraph 7#a71 ! in=mation describ$ 9 ?is p>agraph is1 ) respect to drugs cov]$ by a gr\p heal? plan or gr\p heal? insurance cov]age (f]$ by a heal? insurance issu] 9 connection ) a gr\p heal? plan dur+ ea* report+ p]iod-- 7,a7 9 ! case ( a gr\p heal? plan t is (f]$ by a specifi$ l>ge employ] or t is a specifi$ l>ge plan1 & is n (f]$ z heal? insurance cov]age1 or 9 ! case ( heal? insurance cov]age = :i* ! election "u p>agraph 7#c7 is made = ! applicable report+ p]iod-- 7i7 a li/ ( drugs = :i* a claim 0 fil$ &1 ) respect to ea* su* drug on su* li/-- 7,i7 ! contract$ comp5sation paid by ! gr\p heal? plan or heal? insurance issu] = ea* cov]$ drug 7id5tifi$ by ! ,national ,drug ,code7 to ! entity provid+ ph>macy b5efit managem5t s]vices or o!r applicable entity on behalf ( ! gr\p heal? plan or heal? insurance issu]2 7,,ii7 ! contract$ comp5sation paid to ! ph>macy1 by any entity provid+ ph>macy b5efit managem5t s]vices or o!r applicable entity on behalf ( ! gr\p heal? plan or heal? insurance issu]1 = ea* cov]$ drug 7id5tifi$ by ! ,national ,drug ,code72 7,,iii7 = ea* su* claim1 ! diff]5ce betwe5 ! am\nt paid "u subclause 7,i7 & ! am\nt paid "u subclause 7,,ii72 7,,iv7 ! propriet>y "n1 e/abli%$ "n or prop] "n1 & ! ,national ,drug ,code2 7,v7 = ea* claim = ! drug 7includ+ orig9al prescriptions & refills7 & = ea* dosage unit ( ! drug = :i* a claim 0 fil$1 ! type ( disp5s+ *annel us$ to furni% ! drug1 includ+ retail1 mail ord]1 or specialty ph>macy2 7,,vi7 ) respect to ea* drug disp5s$1 = ea* type ( disp5s+ *annel 7includ+ retail1 mail ord]1 or specialty ph>macy7-- 7aa7 :e!r su* drug is a br& "n drug or a g5]ic drug1 &-- 7,,aa7 9 ! case ( a br& "n drug1 ! :olesale acquisition co/1 li/$ z co/ p] days supply & co/ p] dosage unit1 on ! date su* drug 0 disp5s$2 & 7,,bb7 9 ! case ( a g5]ic drug1 ! av]age :olesale price1 li/$ z co/ p] days supply & co/ p] dosage unit1 on ! date su* drug 0 disp5s$2 & 7bb7 ! total numb] (-- 7,,aa7 prescription claims 7includ+ orig9al prescriptions & refills72 7,,bb7 p>ticipants & b5efici>ies = :om a claim = su* drug 0 fil$ ?r\gh ! applicable disp5s+ *annel2 7,,cc7 dosage units & dosage units p] fill ( su* drug2 & 7,,dd7 days supply ( su* drug p] fill2 7,,vii7 ! net price p] c\rse ( treatm5t or s+le fill1 su* z a #cj-;day supply or #ij-;day supply to ! plan or cov]age aft] rebates1 fees1 alt]native disc\nts1 or o!r remun]ation receiv$ f applicable entities2 7,,viii7 ! total am\nt ( out-(-pocket sp5d+ by p>ticipants & b5efici>ies on su* drug1 includ+ sp5d+ ?r\gh copaym5ts1 co9surance1 & d$uctibles1 b n includ+ any am\nts sp5t by p>ticipants & b5efici>ies on drugs n cov]$ "u ! plan or cov]age1 or = :i* no claim is submitt$ "u ! plan or cov]age2 7,,ix7 ! total net sp5d+ on ! drug2 7,x7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! plan or issu] f any applicable entity 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation2 7,,xi7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! entity provid+ ph>macy b5efit managem5t s]vices1 f applicable entities1 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation f su* entities-- 7aa7 = claims incurr$ dur+ ! report+ p]iod2 & 7bb7 t is relat$ to utilization ( su* drug or sp5d+ on su* drug2 & 7,,xii7 to ! ext5t feasible1 in=mation on ! total am\nt ( remun]ation = su* drug1 includ+ copaym5t assi/ance doll>s paid1 copaym5t c>ds appli$1 or o!r disc\nts provid$ by ea* drug manufactur] 7or entity adm9i/]+ copaym5t assi/ance on behalf ( su* drug manufactur]71 to ! p>ticipants & b5efici>ies enroll$ 9 su* plan or cov]age2 7ii7 a li/ ( ea* !rapeutic class 7z def9$ by ! ,secret>y7 = :i* a claim 0 fil$ "u ! gr\p heal? plan or heal? insurance cov]age dur+ ! report+ p]iod1 &1 ) respect to ea* su* !rapeutic class-- 7,i7 ! total gross sp5d+ on drugs 9 su* class be=e rebates1 price concessions1 alt]native disc\nts1 or o!r remun]ation f applicable entities2 7,,ii7 ! net sp5d+ 9 su* class aft] su* rebates1 price concessions1 alt]native disc\nts1 or o!r remun]ation f applicable entities2 7,,iii7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! entity provid+ ph>macy b5efit managem5t s]vices1 f applicable entities1 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation f su* entities-- 7aa7 = claims incurr$ dur+ ! report+ p]iod2 & 7bb7 t is relat$ to utilization ( drugs or drug sp5d+2 7,,iv7 ! av]age net sp5d+ p] #cj-;day supply & p] #ij-;day supply by ! plan or by ! issu] ) respect to su* cov]age & its p>ticipants & b5efici>ies1 among all drugs )9 ! !rapeutic class = :i* a claim 0 fil$ dur+ ! report+ p]iod2 7,v7 ! numb] ( p>ticipants & b5efici>ies :o fill$ a prescription = a drug 9 su* class1 includ+ ! ,national ,drug ,code = ea* su* drug2 7,,vi7 if applicable1 a description ( ! =mul>y ti]s & utilization me*anisms 7su* z prior au?orization or /ep !rapy7 employ$ = drugs 9 t class2 & 7,,vii7 ! total out-(-pocket sp5d+ "u ! plan or cov]age by p>ticipants & b5efici>ies1 includ+ sp5d+ ?r\gh copaym5ts1 co9surance1 & d$uctibles1 b n includ+ any am\nts sp5t by p>ticipants & b5efici>ies on drugs n cov]$ "u ! plan or cov]age or = :i* no claim is submitt$ "u ! plan or cov]age2 7iii7 ) respect to any drug = :i* gross sp5d+ "u ! gr\p heal? plan or heal? insurance cov]age exce$$ #aj1jjj dur+ ! report+ p]iod or1 9 ! case t gross sp5d+ "u ! gr\p heal? plan or cov]age exce$$ #aj1jjj dur+ ! report+ p]iod ) respect to few] ?an #ej drugs1 ) respect to ! #ej prescription drugs ) ! highe/ sp5d+ dur+ ! report+ p]iod-- 7,i7 a li/ ( all o!r drugs 9 ! same !rapeutic class z su* drug2 7,,ii7 if applicable1 ! rationale = ! =mul>y placem5t ( su* drug 9 t !rapeutic category or class1 select$ f a li/ ( /&>d rationales e/abli%$ by ! ,secret>y1 9 consultation ) /akehold]s2 & 7,,iii7 any *ange 9 =mul>y placem5t comp>$ to ! prior plan ye>2 & 7iv7 9 ! case t su* plan or issu] 7or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* plan or issu]7 has an affiliat$ ph>macy or ph>macy "u common own]%ip1 includ+ m&atory mail & specialty home deliv]y programs1 retail & mail auto-refill programs1 & co/ %>+ assi/ance inc5tives fund$ by an entity provid+ ph>macy b5efit s]vices-- 7,i7 an explanation ( any b5efit design p>amet]s t enc\rage or require p>ticipants & b5efici>ies 9 ! plan or cov]age to fill prescriptions at mail ord]1 specialty1 or retail ph>macies2 7,,ii7 ! p]c5tage ( total prescriptions disp5s$ by su* ph>macies to p>ticipants or b5efici>ies 9 su* plan or cov]age2 & 7,,iii7 a li/ ( all drugs disp5s$ by su* ph>macies to p>ticipants or b5efici>ies enroll$ 9 su* plan or cov]age1 &1 ) respect to ea* drug disp5s$-- 7aa7 ! am\nt *>g$1 p] dosage unit1 p] #cj-;day supply1 or p] #ij-;day supply 7z applicable7 to ! plan or issu]1 & to p>ticipants & b5efici>ies2 7bb7 ! m$ian am\nt *>g$ to su* plan or issu]1 & ! int]qu>tile range ( ! co/s1 p] dosage unit1 p] #cj-;day supply1 & p] #ij-;day supply1 includ+ am\nts paid by ! p>ticipants & b5efici>ies1 :5 ! same drug is disp5s$ by o!r ph>macies t are n affiliat$ ) or "u common own]%ip ) ! entity & t are includ$ 9 ! ph>macy network ( su* plan or cov]age2 7cc7 ! l[e/ co/ p] dosage unit1 p] #cj-;day supply & p] #ij-;day supply1 = ea* su* drug1 includ+ am\nts *>g$ to ! plan or cov]age & to p>ticipants & b5efici>ies1 t is available f any ph>macy includ$ 9 ! network ( su* plan or cov]age2 & 7dd7 ! net acquisition co/ p] dosage unit1 p] #cj-;day supply1 & p] #ij-;day supply1 if su* drug is subject to a maximum price disc\nt2 & 7,b7 ) respect to any gr\p heal? plan1 includ+ gr\p heal? insurance cov]age (f]$ 9 connection ) su* a plan1 reg>dless ( :e!r ! plan or cov]age is (f]$ by a specifi$ l>ge employ] or :e!r x is a specifi$ l>ge plan-- 7i7 a summ>y docum5t = ! gr\p heal? plan t includes su* in=mation describ$ 9 clauses 7i7 ?r\gh 7iv7 ( subp>agraph 7,a71 z specifi$ by ! ,secret>y ?r\gh guidance1 program in/ruction1 or o!rwise 7) no requirem5t ( notice & comm5t rulemak+71 t ! ,secret>y det]m9es useful to gr\p heal? plans = purposes ( select+ ph>macy b5efit managem5t s]vices1 su* z an e/imat$ net price to gr\p heal? plan & p>ticipant or b5efici>y1 a co/ p] claim1 ! fee /ructure or reimbursem5t model1 & e/imat$ co/ p] p>ticipant or b5efici>y2 7ii7 a summ>y docum5t = plans & issu]s to provide to p>ticipants & b5efici>ies1 :i* %all be made available to p>ticipants or b5efici>ies ^u reque/ to _! gr\p heal? plan 7includ+ 9 ! case ( gr\p heal? insurance cov]age (f]$ 9 connection ) su* a plan71 t-- 7,i7 conta9s su* in=mation describ$ 9 clauses 7iii71 7iv71 7v71 & 7vi71 z applicable1 z specifi$ by ! ,secret>y ?r\gh guidance1 program in/ruction1 or o!rwise 7) no requirem5t ( notice & comm5t rulemak+7 t ! ,secret>y det]m9es useful to p>ticipants or b5efici>ies 9 bett] und]/&+ ! plan or cov]age or b5efits "u su* plan or cov]age2 7,,ii7 conta9s only aggregate in=mation2 & 7,,iii7 /ates t p>ticipants & b5efici>ies may reque/ specific1 claims-level in=mation requir$ to be furni%$ "u subsection 7c7 f ! gr\p heal? plan or heal? insurance issu]2 & 7iii7 ) respect to drugs cov]$ by su* plan or cov]age dur+ su* report+ p]iod-- 7,i7 ! total net sp5d+ by ! plan or cov]age = all su* drugs2 7,,ii7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! plan or issu] f any applicable entity 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation2 & 7,,iii7 to ! ext5t feasible1 in=mation on ! total am\nt ( remun]ation = su* drugs1 includ+ copaym5t assi/ance doll>s paid1 copaym5t c>ds appli$1 or o!r disc\nts provid$ by ea* drug manufactur] 7or entity adm9i/]+ copaym5t assi/ance on behalf ( su* drug manufactur]7 to p>ticipants & b5efici>ies2 7iv7 am\nts paid directly or indirectly 9 rebates1 fees1 or any o!r type ( comp5sation 7z def9$ 9 section #djh7;b77#b77;,b77ii77dd77,,aa77 to brok]age firms1 brok]s1 consultants1 advisors1 or any o!r individual or firm1 =-- 7,i7 ! ref]ral ( ! gr\p heal? plan's or heal? insurance issu]'s bus9ess to an entity provid+ ph>macy b5efit managem5t s]vices1 includ+ ! id5tity ( ! recipi5t ( su* am\nts2 7,,ii7 consid]ation ( ! entity provid+ ph>macy b5efit managem5t s]vices by ! gr\p heal? plan or heal? insurance issu]2 or 7,,iii7 ! ret5tion ( ! entity by ! gr\p heal? plan or heal? insurance issu]2 7v7 an explanation ( any b5efit design p>amet]s t enc\rage or require p>ticipants & b5efici>ies 9 su* plan or cov]age to fill prescriptions at mail ord]1 specialty1 or retail ph>macies t are affiliat$ ) or "u common own]%ip ) ! entity provid+ ph>macy b5efit managem5t s]vices "u su* plan or cov]age1 includ+ m&atory mail & specialty home deliv]y programs1 retail & mail auto-refill programs1 & co/-%>+ assi/ance inc5tives directly or indirectly fund$ by su* entity2 & 7vi7 total gross sp5d+ on all drugs "u ! plan or cov]age dur+ ! report+ p]iod4 7#c7 ,opt-9 = gr\p heal? insurance cov]age (f]$ by a specifi$ l>ge employ] or t is a specifi$ l>ge plan ,9 ! case ( gr\p heal? insurance cov]age (f]$ 9 connection ) a gr\p heal? plan t is (f]$ by a specifi$ l>ge employ] or is a specifi$ l>ge plan1 su* gr\p heal? plan may1 on an annual basis1 = plan ye>s beg9n+ on or aft] ! date t is #cj mon?s aft] ! date ( enactm5t ( ?is section1 elect to require an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( ! heal? insurance issu] to submit to su* gr\p heal? plan a report t includes all ( ! in=mation describ$ 9 p>agraph 7#b77;,a71 9 addition to ! in=mation describ$ 9 p>agraph 7#b77;,b74 7#d7 ,privacy requirem5ts 7,a7 ,9 g5]al ,an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or a heal? insurance issu] (f]+ gr\p heal? insurance cov]age %all report in=mation "u p>agraph 7#a7 9 a mann] consi/5t ) ! privacy regulations promulgat$ "u section #acdjb7;a7 ( ! ,heal? ,in=mation ,te*nology = ,economic & ,cl9ical ,heal? ,act 7#db ,u4,s4,c4 #agicb7;a77 & consi/5t ) ! privacy regulations promulgat$ "u ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 9 "p #afj & subp>ts ,a & ,e ( "p #afd ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations7 7ref]r$ to 9 ?is p>agraph z ! ,,hipaa privacy regulations7 & %all re/rict ! use & disclosure ( su* in=mation accord+ to su* privacy regulations & su* ,,hipaa privacy regulations4 7,b7 ,additional requirem5ts 7i7 ,9 g5]al ,an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age t submits a report "u p>agraph 7#a7 %all ensure t su* report conta9s only summ>y heal? in=mation1 z def9$ 9 section #afd4ejd7;a7 ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7ii7 ,re/rictions ,9 c>ry+ out ?is subsection1 a gr\p heal? plan %all comply ) section #afd4ejd7;f7 ( title #de1 ,code ( ,f$]al ,regulations 7or a successor regulation71 & a plan sponsor %all act 9 accordance ) ! t]ms ( ! agreem5t describ$ 9 su* section4 7,c7 ,rule ( con/ruction 7i7 ,no?+ 9 ?is section %all be con/ru$ to modify ! requirem5ts = ! creation1 receipt1 ma9t5ance1 or transmission ( protect$ heal? in=mation "u ! ,,hipaa privacy regulations4 7ii7 ,no?+ 9 ?is section %all be con/ru$ to affect ! application ( any ,f$]al or ,/ate privacy or civil rights law1 includ+ ! ,,hipaa privacy regulations1 ! ,g5etic ,in=mation ,nondiscrim9ation ,act ( #bjjh 7,public ,law #aaj-bcc7 7includ+ ! am5dm5ts made by su* ,act71 ! ,am]icans ) ,disabilities ,act ( #aiij 7#db ,u4,s4,c4 #abaja et seq471 section #ejd ( ! ,rehabilitation ,act ( #aigc 7#bi ,u4,s4,c4 #gid71 section #aeeg ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahaaf71 title ,,vi ( ! ,civil ,rights ,act ( #aifd 7#db ,u4,s4,c4 #bjjj;d71 & title ,,vii ( ! ,civil ,rights ,act ( #aifd 7#db ,u4,s4,c4 #bjjj;e74 7,d7 ,writt5 notice ,ea* plan ye>1 gr\p heal? plans1 includ+ ) respect to gr\p heal? insurance cov]age (f]$ 9 connection ) a gr\p heal? plan1 %all provide to ea* p>ticipant or b5efici>y writt5 notice in=m+ ! p>ticipant or b5efici>y ( ! requirem5t = entities provid+ ph>macy b5efit managem5t s]vices on behalf ( ! gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age to submit reports to gr\p heal? plans "u p>agraph 7#a71 z applicable1 :i* may include incorporat+ su* notification 9 plan docum5ts provid$ to ! p>ticipant or b5efici>y1 or provid+ individual notification4 7,e7 ,limitation to bus9ess associates ,a gr\p heal? plan receiv+ a report "u p>agraph 7#a7 may disclose su* in=mation only to ! entity f :i* ! report 0 receiv$ or to t entity's bus9ess associates z def9$ 9 section #afj4ajc ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations7 or z p]mitt$ by ! ,,hipaa privacy regulations4 7,f7 ,cl>ification reg>d+ public disclosure ( in=mation ,no?+ 9 ?is section %all prev5t an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 f plac+ reasonable re/rictions on ! public disclosure ( ! in=mation conta9$ 9 a report describ$ 9 p>agraph 7#a71 except t su* plan1 issu]1 or entity may n-- 7i7 re/rict disclosure ( su* report to ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,dep>tm5t ( ,labor1 or ! ,dep>tm5t ( ! ,treasury2 or 7ii7 prev5t disclosure = ! purposes ( subsection 7c71 or any o!r public disclosure requirem5t "u ?is section4 7,g7 ,limit$ =m ( report ,! ,secret>y %all def9e ?r\gh rulemak+ a limit$ =m ( ! report "u p>agraph 7#a7 requir$ ) respect to any gr\p heal? plan e/abli%$ by a plan sponsor t is1 or is affiliat$ )1 a drug manufactur]1 drug :olesal]1 or o!r direct p>ticipant 9 ! drug supply *a91 9 ord] to prev5t anti-competitive behavior4 7#e7 ,/&>d =mat & regulations 7,a7 ,9 g5]al ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all specify ?r\gh rulemak+ a /&>d =mat = entities provid+ ph>macy b5efit managem5t s]vices on behalf ( gr\p heal? plans & heal? insurance issu]s (f]+ gr\p heal? insurance cov]age1 to submit reports requir$ "u p>agraph 7#a74 7,b7 ,additional regulations ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all1 ?r\gh rulemak+1 promulgate any o!r f9al regulations necess>y to implem5t ! requirem5ts ( ?is section4 ,9 promulgat+ su* regulations1 ! ,secret>y %all1 to ! ext5t practicable1 align ! report+ requirem5ts "u ?is section ) ! report+ requirem5ts "u section #gbe4 7c7 ,requirem5t ,to provide in=mation to p>ticipants or b5efici>ies ,a gr\p heal? plan1 includ+ ) respect to gr\p heal? insurance cov]age (f]$ 9 connection ) a gr\p heal? plan1 ^u reque/ ( a p>ticipant or b5efici>y1 %all provide to su* p>ticipant or b5efici>y-- 7#a7 ! summ>y docum5t describ$ 9 subsection 7b77#b77;,b77ii72 & 7#b7 ! in=mation describ$ 9 subsection 7b77#b77;,a77i77,,iii7 ) respect to a claim made by or on behalf ( su* p>ticipant or b5efici>y4 7d7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to p]mit a heal? insurance issu]1 gr\p heal? plan1 entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or heal? insurance issu]1 or o!r entity to re/rict disclosure to1 or o!rwise limit ! access (1 ! ,secret>y to a report describ$ 9 subsection 7b77#a7 or in=mation relat$ to compliance ) subsections 7a71 7b71 or 7c7 ( ?is section or section #ejb7;c77#ac7 by su* issu]1 plan1 or entity4 7e7 ,def9itions ,9 ?is section3 7#a7 ,applicable entity ,! t]m applicable entity means-- 7,a7 an applicable gr\p pur*as+ organization1 drug manufactur]1 di/ributor1 :olesal]1 rebate aggregator 7or o!r pur*as+ entity design$ to aggregate rebates71 or associat$ ?ird p>ty2 7,b7 any subsidi>y1 p>5t1 affiliate1 or subcontractor ( a gr\p heal? plan1 heal? insurance issu]1 entity t provides ph>macy b5efit managem5t s]vices on behalf ( su* a plan or issu]1 or any entity describ$ 9 subp>agraph 7,a72 or 7,c7 su* o!r entity z ! ,secret>y may specify ?r\gh rulemak+4 7#b7 ,applicable gr\p pur*as+ organization ,! t]m applicable gr\p pur*as+ organization means a gr\p pur*as+ organization t is affiliat$ ) or "u common own]%ip ) an entity provid+ ph>macy b5efit managem5t s]vices4 7#c7 ,contract$ comp5sation ,! t]m contract$ comp5sation means ! sum ( any +r$i5t co/ & disp5s+ fee = a drug 7inclusive ( ! out-(-pocket co/s to ! p>ticipant or b5efici>y71 or ano!r analog\s comp5sation /ructure t ! ,secret>y may specify ?r\gh regulations4 7#d7 ,gross sp5d+ ,! t]m gross sp5d+1 ) respect to prescription drug b5efits "u a gr\p heal? plan or heal? insurance cov]age1 means ! am\nt sp5t by a gr\p heal? plan or heal? insurance issu] on prescription drug b5efits1 calculat$ be=e ! application ( rebates1 fees1 alt]native disc\nts1 or o!r remun]ation4 7#e7 ,net sp5d+ ,! t]m net sp5d+1 ) respect to prescription drug b5efits "u a gr\p heal? plan or heal? insurance cov]age1 means ! am\nt sp5t by a gr\p heal? plan or heal? insurance issu] on prescription drug b5efits1 calculat$ aft] ! application ( rebates1 fees1 alt]native disc\nts1 or o!r remun]ation4 7#f7 ,plan sponsor ,! t]m plan sponsor has ! mean+ giv5 su* t]m 9 section #c7af77;,b74 7#g7 ,remun]ation ,! t]m remun]ation has ! mean+ giv5 su* t]m by ! ,secret>y ?r\gh rulemak+1 :i* %all be reevaluat$ by ! ,secret>y e #e ye>s4 7#h7 ,specifi$ l>ge employ] ,! t]m specifi$ l>ge employ] means1 9 connection ) a gr\p heal? plan 7includ+ gr\p heal? insurance cov]age (f]$ 9 connection ) su* a plan7 e/abli%$ or ma9ta9$ by a s+le employ]1 ) respect to a cal5d> ye> or a plan ye>1 z applicable1 an employ] :o employ$ an av]age ( at lea/ #ajj employees on bus9ess days dur+ ! prec$+ cal5d> ye> or plan ye> & :o employs at lea/ #a employee on ! fir/ day ( ! cal5d> ye> or plan ye>4 7#i7 ,specifi$ l>ge plan ,! t]m specifi$ l>ge plan means a gr\p heal? plan 7includ+ gr\p heal? insurance cov]age (f]$ 9 connection ) su* a plan7 e/abli%$ or ma9ta9$ by a plan sponsor describ$ 9 clause 7ii7 or 7iii7 ( section #c7af77;,b7 t _h an av]age ( at lea/ #ajj p>ticipants on bus9ess days dur+ ! prec$+ cal5d> ye> or plan ye>1 z applicable4 7#aj7 ,:olesale acquisition co/ ,! t]m :olesale acquisition co/ has ! mean+ giv5 su* t]m 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b774 2 7,b7 9 section #ejb 7#bi ,u4,s4,c4 #aacb7-- 7i7 9 subsection 7a77#f71 by /rik+ or 7#i7 & ins]t+ 7#i71 or 7#ac72 7ii7 9 subsection 7b77#c71 by /rik+ "u subsection 7c77#i7 & ins]t+ "u p>agraphs 7#i7 & 7#ac7 ( subsection 7c72 & 7iii7 9 subsection 7c71 by add+ at ! end ! foll[+3 7#ac7 ,secret>ial en=cem5t au?ority relat+ to ov]sight ( ph>macy b5efit managem5t s]vices 7,a7 ,failure to provide in=mation ,! ,secret>y may impose a p5alty aga9/ a plan adm9i/rator ( a gr\p heal? plan1 a heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan or issu]1 or an applicable entity 7z def9$ 9 section #gbf7;f77 t violates section #gbf7;a72 an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan or issu] t fails to provide ! in=mation requir$ "u section #gbf7;b72 or any p]son :o causes a gr\p heal? plan to fail to provide ! in=mation requir$ "u section #gbf7;c71 9 ! am\nt ( #aj1jjj = ea* day dur+ :i* su* violation cont9ues or su* in=mation is n disclos$ or report$4 7,b7 ,false in=mation ,! ,secret>y may impose a p5alty aga9/ a plan adm9i/rator ( a gr\p heal? plan1 a heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 an entity provid+ ph>macy b5efit managem5t s]vices1 or an applicable entity 7z def9$ 9 section #gbf7;f77 t kn[+ly provides false in=mation "u section #gbf1 9 an am\nt n to exce$ #ajj1jjj = ea* item ( false in=mation4 ,su* p5alty %all be 9 addition to o!r p5alties z may be prescrib$ by law4 7,c7 ,waiv]s ,! ,secret>y may waive p5alties "u subp>agraph 7,a71 or ext5d ! p]iod ( "t = compliance ) a requirem5t ( ?is section1 = an entity 9 violation ( section #gbf t has made a good-fai? ef=t to comply ) ! requirem5ts ( section #gbf4 2 & 7,c7 9 section #gcb7;a7 7#bi ,u4,s4,c4 #aaia;a7a771 by /rik+ section #gaa & ins]t+ sections #gaa & #gbf4 7#b7 ,cl]ical am5dm5t ,! table ( cont5ts 9 section #a ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #ajja et seq47 is am5d$ by ins]t+ aft] ! item relat+ to section #gbe ! foll[+ new item3 ,sec4 #gbf4 ,ov]sight ( entities t provide ph>macy b5efit managem5t s]vices4 4 7c7 ,int]nal ,rev5ue ,code ( #aihf 7#a7 ,9 g5]al ,*apt] #ajj ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$-- 7,a7 by add+ at ! end ( sub*apt] ,b ! foll[+3 #ihbf4 ,ov]sight ( entities t provide ph>macy b5efit managem5t s]vices 7a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ! date t is #cj mon?s aft] ! date ( enactm5t ( ?is section 7ref]r$ to 9 ?is subsection & subsection 7b7 z ! effective date71 a gr\p heal? plan1 or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan1 %all n ent] into a contract1 includ+ an ext5sion or r5ewal ( a contract1 ent]$ into on or aft] ! effective date1 ) an applicable entity unless su* applicable entity agrees to-- 7#a7 n limit or delay ! disclosure ( in=mation to ! gr\p heal? plan 9 su* a mann] t prev5ts an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan f mak+ ! reports describ$ 9 subsection 7b72 & 7#b7 provide ! entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan relevant in=mation necess>y to make ! reports describ$ 9 subsection 7b74 7b7 ,reports 7#a7 ,9 g5]al ,= plan ye>s beg9n+ on or aft] ! effective date1 9 ! case ( any contract betwe5 a gr\p heal? plan & an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* plan1 includ+ an ext5sion or r5ewal ( su* a contract1 ent]$ into on or aft] ! effective date1 ! entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a gr\p heal? plan1 n less frequ5tly ?an e #f mon?s 7or1 at ! reque/ ( a gr\p heal? plan1 n less frequ5tly ?an qu>t]ly1 & "u ! same conditions1 t]ms1 & co/ ( ! semiannual report "u ?is subsection71 %all submit to ! gr\p heal? plan a report 9 accordance ) ?is section4 ,ea* su* report %all be made available to su* gr\p heal? plan 9 pla9 language1 9 a ma*9e-readable =mat1 & z ! ,secret>y may det]m9e1 o!r =mats4 ,ea* su* report %all include ! in=mation describ$ 9 p>agraph 7#b74 7#b7 ,in=mation describ$ ,= purposes ( p>agraph 7#a71 ! in=mation describ$ 9 ?is p>agraph is1 ) respect to drugs cov]$ by a gr\p heal? plan dur+ ea* report+ p]iod-- 7,a7 9 ! case ( a gr\p heal? plan t is (f]$ by a specifi$ l>ge employ] or t is a specifi$ l>ge plan1 & is n (f]$ z heal? insurance cov]age1 or 9 ! case ( heal? insurance cov]age = :i* ! election "u p>agraph 7#c7 is made = ! applicable report+ p]iod-- 7i7 a li/ ( drugs = :i* a claim 0 fil$ &1 ) respect to ea* su* drug on su* li/-- 7,i7 ! contract$ comp5sation paid by ! gr\p heal? plan = ea* cov]$ drug 7id5tifi$ by ! ,national ,drug ,code7 to ! entity provid+ ph>macy b5efit managem5t s]vices or o!r applicable entity on behalf ( ! gr\p heal? plan2 7,,ii7 ! contract$ comp5sation paid to ! ph>macy1 by any entity provid+ ph>macy b5efit managem5t s]vices or o!r applicable entity on behalf ( ! gr\p heal? plan1 = ea* cov]$ drug 7id5tifi$ by ! ,national ,drug ,code72 7,,iii7 = ea* su* claim1 ! diff]5ce betwe5 ! am\nt paid "u subclause 7,i7 & ! am\nt paid "u subclause 7,,ii72 7,,iv7 ! propriet>y "n1 e/abli%$ "n or prop] "n1 & ! ,national ,drug ,code2 7,v7 = ea* claim = ! drug 7includ+ orig9al prescriptions & refills7 & = ea* dosage unit ( ! drug = :i* a claim 0 fil$1 ! type ( disp5s+ *annel us$ to furni% ! drug1 includ+ retail1 mail ord]1 or specialty ph>macy2 7,,vi7 ) respect to ea* drug disp5s$1 = ea* type ( disp5s+ *annel 7includ+ retail1 mail ord]1 or specialty ph>macy7-- 7aa7 :e!r su* drug is a br& "n drug or a g5]ic drug1 &-- 7,,aa7 9 ! case ( a br& "n drug1 ! :olesale acquisition co/1 li/$ z co/ p] days supply & co/ p] dosage unit1 on ! date su* drug 0 disp5s$2 & 7,,bb7 9 ! case ( a g5]ic drug1 ! av]age :olesale price1 li/$ z co/ p] days supply & co/ p] dosage unit1 on ! date su* drug 0 disp5s$2 & 7bb7 ! total numb] (-- 7,,aa7 prescription claims 7includ+ orig9al prescriptions & refills72 7,,bb7 p>ticipants & b5efici>ies = :om a claim = su* drug 0 fil$ ?r\gh ! applicable disp5s+ *annel2 7,,cc7 dosage units & dosage units p] fill ( su* drug2 & 7,,dd7 days supply ( su* drug p] fill2 7,,vii7 ! net price p] c\rse ( treatm5t or s+le fill1 su* z a #cj-;day supply or #ij-;day supply to ! plan aft] rebates1 fees1 alt]native disc\nts1 or o!r remun]ation receiv$ f applicable entities2 7,,viii7 ! total am\nt ( out-(-pocket sp5d+ by p>ticipants & b5efici>ies on su* drug1 includ+ sp5d+ ?r\gh copaym5ts1 co9surance1 & d$uctibles1 b n includ+ any am\nts sp5t by p>ticipants & b5efici>ies on drugs n cov]$ "u ! plan1 or = :i* no claim is submitt$ "u ! plan2 7,,ix7 ! total net sp5d+ on ! drug2 7,x7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! plan f any applicable entity 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation2 7,,xi7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! entity provid+ ph>macy b5efit managem5t s]vices1 f applicable entities1 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation f su* entities-- 7aa7 = claims incurr$ dur+ ! report+ p]iod2 & 7bb7 t is relat$ to utilization ( su* drug or sp5d+ on su* drug2 & 7,,xii7 to ! ext5t feasible1 in=mation on ! total am\nt ( remun]ation = su* drug1 includ+ copaym5t assi/ance doll>s paid1 copaym5t c>ds appli$1 or o!r disc\nts provid$ by ea* drug manufactur] 7or entity adm9i/]+ copaym5t assi/ance on behalf ( su* drug manufactur]71 to ! p>ticipants & b5efici>ies enroll$ 9 su* plan2 7ii7 a li/ ( ea* !rapeutic class 7z def9$ by ! ,secret>y7 = :i* a claim 0 fil$ "u ! gr\p heal? plan dur+ ! report+ p]iod1 &1 ) respect to ea* su* !rapeutic class-- 7,i7 ! total gross sp5d+ on drugs 9 su* class be=e rebates1 price concessions1 alt]native disc\nts1 or o!r remun]ation f applicable entities2 7,,ii7 ! net sp5d+ 9 su* class aft] su* rebates1 price concessions1 alt]native disc\nts1 or o!r remun]ation f applicable entities2 7,,iii7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! entity provid+ ph>macy b5efit managem5t s]vices1 f applicable entities1 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation f su* entities-- 7aa7 = claims incurr$ dur+ ! report+ p]iod2 & 7bb7 t is relat$ to utilization ( drugs or drug sp5d+2 7,,iv7 ! av]age net sp5d+ p] #cj-;day supply & p] #ij-;day supply by ! plan & its p>ticipants & b5efici>ies1 among all drugs )9 ! !rapeutic class = :i* a claim 0 fil$ dur+ ! report+ p]iod2 7,v7 ! numb] ( p>ticipants & b5efici>ies :o fill$ a prescription = a drug 9 su* class1 includ+ ! ,national ,drug ,code = ea* su* drug2 7,,vi7 if applicable1 a description ( ! =mul>y ti]s & utilization me*anisms 7su* z prior au?orization or /ep !rapy7 employ$ = drugs 9 t class2 & 7,,vii7 ! total out-(-pocket sp5d+ "u ! plan by p>ticipants & b5efici>ies1 includ+ sp5d+ ?r\gh copaym5ts1 co9surance1 & d$uctibles1 b n includ+ any am\nts sp5t by p>ticipants & b5efici>ies on drugs n cov]$ "u ! plan or = :i* no claim is submitt$ "u ! plan2 7iii7 ) respect to any drug = :i* gross sp5d+ "u ! gr\p heal? plan exce$$ #aj1jjj dur+ ! report+ p]iod or1 9 ! case t gross sp5d+ "u ! gr\p heal? plan exce$$ #aj1jjj dur+ ! report+ p]iod ) respect to few] ?an #ej drugs1 ) respect to ! #ej prescription drugs ) ! highe/ sp5d+ dur+ ! report+ p]iod-- 7,i7 a li/ ( all o!r drugs 9 ! same !rapeutic class z su* drug2 7,,ii7 if applicable1 ! rationale = ! =mul>y placem5t ( su* drug 9 t !rapeutic category or class1 select$ f a li/ ( /&>d rationales e/abli%$ by ! ,secret>y1 9 consultation ) /akehold]s2 & 7,,iii7 any *ange 9 =mul>y placem5t comp>$ to ! prior plan ye>2 & 7iv7 9 ! case t su* plan 7or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* plan7 has an affiliat$ ph>macy or ph>macy "u common own]%ip1 includ+ m&atory mail & specialty home deliv]y programs1 retail & mail auto-refill programs1 & co/ %>+ assi/ance inc5tives fund$ by an entity provid+ ph>macy b5efit s]vices-- 7,i7 an explanation ( any b5efit design p>amet]s t enc\rage or require p>ticipants & b5efici>ies 9 ! plan to fill prescriptions at mail ord]1 specialty1 or retail ph>macies2 7,,ii7 ! p]c5tage ( total prescriptions disp5s$ by su* ph>macies to p>ticipants or b5efici>ies 9 su* plan2 & 7,,iii7 a li/ ( all drugs disp5s$ by su* ph>macies to p>ticipants or b5efici>ies enroll$ 9 su* plan1 &1 ) respect to ea* drug disp5s$-- 7aa7 ! am\nt *>g$1 p] dosage unit1 p] #cj-;day supply1 or p] #ij-;day supply 7z applicable7 to ! plan1 & to p>ticipants & b5efici>ies2 7bb7 ! m$ian am\nt *>g$ to su* plan1 & ! int]qu>tile range ( ! co/s1 p] dosage unit1 p] #cj-;day supply1 & p] #ij-;day supply1 includ+ am\nts paid by ! p>ticipants & b5efici>ies1 :5 ! same drug is disp5s$ by o!r ph>macies t are n affiliat$ ) or "u common own]%ip ) ! entity & t are includ$ 9 ! ph>macy network ( su* plan2 7cc7 ! l[e/ co/ p] dosage unit1 p] #cj-;day supply & p] #ij-;day supply1 = ea* su* drug1 includ+ am\nts *>g$ to ! plan & to p>ticipants & b5efici>ies1 t is available f any ph>macy includ$ 9 ! network ( su* plan2 & 7dd7 ! net acquisition co/ p] dosage unit1 p] #cj-;day supply1 & p] #ij-;day supply1 if su* drug is subject to a maximum price disc\nt2 & 7,b7 ) respect to any gr\p heal? plan1 reg>dless ( :e!r ! plan is (f]$ by a specifi$ l>ge employ] or :e!r x is a specifi$ l>ge plan-- 7i7 a summ>y docum5t = ! gr\p heal? plan t includes su* in=mation describ$ 9 clauses 7i7 ?r\gh 7iv7 ( subp>agraph 7,a71 z specifi$ by ! ,secret>y ?r\gh guidance1 program in/ruction1 or o!rwise 7) no requirem5t ( notice & comm5t rulemak+71 t ! ,secret>y det]m9es useful to gr\p heal? plans = purposes ( select+ ph>macy b5efit managem5t s]vices1 su* z an e/imat$ net price to gr\p heal? plan & p>ticipant or b5efici>y1 a co/ p] claim1 ! fee /ructure or reimbursem5t model1 & e/imat$ co/ p] p>ticipant or b5efici>y2 7ii7 a summ>y docum5t = plans to provide to p>ticipants & b5efici>ies1 :i* %all be made available to p>ticipants or b5efici>ies ^u reque/ to _! gr\p heal? plan1 t-- 7,i7 conta9s su* in=mation describ$ 9 clauses 7iii71 7iv71 7v71 & 7vi71 z applicable1 z specifi$ by ! ,secret>y ?r\gh guidance1 program in/ruction1 or o!rwise 7) no requirem5t ( notice & comm5t rulemak+7 t ! ,secret>y det]m9es useful to p>ticipants or b5efici>ies 9 bett] und]/&+ ! plan or b5efits "u su* plan2 7,,ii7 conta9s only aggregate in=mation2 & 7,,iii7 /ates t p>ticipants & b5efici>ies may reque/ specific1 claims-level in=mation requir$ to be furni%$ "u subsection 7c7 f ! gr\p heal? plan2 & 7iii7 ) respect to drugs cov]$ by su* plan dur+ su* report+ p]iod-- 7,i7 ! total net sp5d+ by ! plan = all su* drugs2 7,,ii7 ! total am\nt receiv$1 or expect$ to be receiv$1 by ! plan f any applicable entity 9 rebates1 fees1 alt]native disc\nts1 or o!r remun]ation2 & 7,,iii7 to ! ext5t feasible1 in=mation on ! total am\nt ( remun]ation = su* drugs1 includ+ copaym5t assi/ance doll>s paid1 copaym5t c>ds appli$1 or o!r disc\nts provid$ by ea* drug manufactur] 7or entity adm9i/]+ copaym5t assi/ance on behalf ( su* drug manufactur]7 to p>ticipants & b5efici>ies2 7iv7 am\nts paid directly or indirectly 9 rebates1 fees1 or any o!r type ( comp5sation 7z def9$ 9 section #djh7;b77#b77;,b77ii77dd77,,aa7 ( ! ,employee ,retirem5t ,income ,security ,act 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77ii77dd77,,aa777 to brok]age firms1 brok]s1 consultants1 advisors1 or any o!r individual or firm1 =-- 7,i7 ! ref]ral ( ! gr\p heal? plan's bus9ess to an entity provid+ ph>macy b5efit managem5t s]vices1 includ+ ! id5tity ( ! recipi5t ( su* am\nts2 7,,ii7 consid]ation ( ! entity provid+ ph>macy b5efit managem5t s]vices by ! gr\p heal? plan2 or 7,,iii7 ! ret5tion ( ! entity by ! gr\p heal? plan2 7v7 an explanation ( any b5efit design p>amet]s t enc\rage or require p>ticipants & b5efici>ies 9 su* plan to fill prescriptions at mail ord]1 specialty1 or retail ph>macies t are affiliat$ ) or "u common own]%ip ) ! entity provid+ ph>macy b5efit managem5t s]vices "u su* plan1 includ+ m&atory mail & specialty home deliv]y programs1 retail & mail auto-refill programs1 & co/-%>+ assi/ance inc5tives directly or indirectly fund$ by su* entity2 & 7vi7 total gross sp5d+ on all drugs "u ! plan dur+ ! report+ p]iod4 7#c7 ,opt-9 = gr\p heal? insurance cov]age (f]$ by a specifi$ l>ge employ] or t is a specifi$ l>ge plan ,9 ! case ( gr\p heal? insurance cov]age (f]$ 9 connection ) a gr\p heal? plan t is (f]$ by a specifi$ l>ge employ] or is a specifi$ l>ge plan1 su* gr\p heal? plan may1 on an annual basis1 = plan ye>s beg9n+ on or aft] ! date t is #cj mon?s aft] ! date ( enactm5t ( ?is section1 elect to require an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( ! heal? insurance issu] to submit to su* gr\p heal? plan a report t includes all ( ! in=mation describ$ 9 p>agraph 7#b77;,a71 9 addition to ! in=mation describ$ 9 p>agraph 7#b77;,b74 7#d7 ,privacy requirem5ts 7,a7 ,9 g5]al ,an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan %all report in=mation "u p>agraph 7#a7 9 a mann] consi/5t ) ! privacy regulations promulgat$ "u section #acdjb7;a7 ( ! ,heal? ,in=mation ,te*nology = ,economic & ,cl9ical ,heal? ,act 7#db ,u4,s4,c4 #agicb7;a77 & consi/5t ) ! privacy regulations promulgat$ "u ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 9 "p #afj & subp>ts ,a & ,e ( "p #afd ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations7 7ref]r$ to 9 ?is p>agraph z ! ,,hipaa privacy regulations7 & %all re/rict ! use & disclosure ( su* in=mation accord+ to su* privacy regulations & su* ,,hipaa privacy regulations4 7,b7 ,additional requirem5ts 7i7 ,9 g5]al ,an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan t submits a report "u p>agraph 7#a7 %all ensure t su* report conta9s only summ>y heal? in=mation1 z def9$ 9 section #afd4ejd7;a7 ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7ii7 ,re/rictions ,9 c>ry+ out ?is subsection1 a gr\p heal? plan %all comply ) section #afd4ejd7;f7 ( title #de1 ,code ( ,f$]al ,regulations 7or a successor regulation71 & a plan sponsor %all act 9 accordance ) ! t]ms ( ! agreem5t describ$ 9 su* section4 7,c7 ,rule ( con/ruction 7i7 ,no?+ 9 ?is section %all be con/ru$ to modify ! requirem5ts = ! creation1 receipt1 ma9t5ance1 or transmission ( protect$ heal? in=mation "u ! ,,hipaa privacy regulations4 7ii7 ,no?+ 9 ?is section %all be con/ru$ to affect ! application ( any ,f$]al or ,/ate privacy or civil rights law1 includ+ ! ,,hipaa privacy regulations1 ! ,g5etic ,in=mation ,nondiscrim9ation ,act ( #bjjh 7,public ,law #aaj-bcc7 7includ+ ! am5dm5ts made by su* ,act71 ! ,am]icans ) ,disabilities ,act ( #aiij 7#db ,u4,s4,c4 #abaja et seq471 section #ejd ( ! ,rehabilitation ,act ( #aigc 7#bi ,u4,s4,c4 #gid71 section #aeeg ( ! ,pati5t ,protection & ,af=dable ,c>e ,act 7#db ,u4,s4,c4 #ahaaf71 title ,,vi ( ! ,civil ,rights ,act ( #aifd 7#db ,u4,s4,c4 #bjjj;d71 & title ,,vii ( ! ,civil ,rights ,act ( #aifd 7#db ,u4,s4,c4 #bjjj;e74 7,d7 ,writt5 notice ,ea* plan ye>1 gr\p heal? plans %all provide to ea* p>ticipant or b5efici>y writt5 notice in=m+ ! p>ticipant or b5efici>y ( ! requirem5t = entities provid+ ph>macy b5efit managem5t s]vices on behalf ( ! gr\p heal? plan to submit reports to gr\p heal? plans "u p>agraph 7#a71 z applicable1 :i* may include incorporat+ su* notification 9 plan docum5ts provid$ to ! p>ticipant or b5efici>y1 or provid+ individual notification4 7,e7 ,limitation to bus9ess associates ,a gr\p heal? plan receiv+ a report "u p>agraph 7#a7 may disclose su* in=mation only to ! entity f :i* ! report 0 receiv$ or to t entity's bus9ess associates z def9$ 9 section #afj4ajc ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations7 or z p]mitt$ by ! ,,hipaa privacy regulations4 7,f7 ,cl>ification reg>d+ public disclosure ( in=mation ,no?+ 9 ?is section %all prev5t an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan1 f plac+ reasonable re/rictions on ! public disclosure ( ! in=mation conta9$ 9 a report describ$ 9 p>agraph 7#a71 except t su* plan or entity may n-- 7i7 re/rict disclosure ( su* report to ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,dep>tm5t ( ,labor1 or ! ,dep>tm5t ( ! ,treasury2 or 7ii7 prev5t disclosure = ! purposes ( subsection 7c71 or any o!r public disclosure requirem5t "u ?is section4 7,g7 ,limit$ =m ( report ,! ,secret>y %all def9e ?r\gh rulemak+ a limit$ =m ( ! report "u p>agraph 7#a7 requir$ ) respect to any gr\p heal? plan e/abli%$ by a plan sponsor t is1 or is affiliat$ )1 a drug manufactur]1 drug :olesal]1 or o!r direct p>ticipant 9 ! drug supply *a91 9 ord] to prev5t anti-competitive behavior4 7#e7 ,/&>d =mat & regulations 7,a7 ,9 g5]al ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all specify ?r\gh rulemak+ a /&>d =mat = entities provid+ ph>macy b5efit managem5t s]vices on behalf ( gr\p heal? plans1 to submit reports requir$ "u p>agraph 7#a74 7,b7 ,additional regulations ,n lat] ?an #ah mon?s aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all1 ?r\gh rulemak+1 promulgate any o!r f9al regulations necess>y to implem5t ! requirem5ts ( ?is section4 ,9 promulgat+ su* regulations1 ! ,secret>y %all1 to ! ext5t practicable1 align ! report+ requirem5ts "u ?is section ) ! report+ requirem5ts "u section #ihbe4 7c7 ,requirem5t ,to provide in=mation to p>ticipants or b5efici>ies ,a gr\p heal? plan1 ^u reque/ ( a p>ticipant or b5efici>y1 %all provide to su* p>ticipant or b5efici>y-- 7#a7 ! summ>y docum5t describ$ 9 subsection 7b77#b77;,b77ii72 & 7#b7 ! in=mation describ$ 9 subsection 7b77#b77;,a77i77,,iii7 ) respect to a claim made by or on behalf ( su* p>ticipant or b5efici>y4 7d7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to p]mit a heal? insurance issu]1 gr\p heal? plan1 entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan or heal? insurance issu]1 or o!r entity to re/rict disclosure to1 or o!rwise limit ! access (1 ! ,secret>y to a report describ$ 9 subsection 7b77#a7 or in=mation relat$ to compliance ) subsections 7a71 7b71 or 7c7 ( ?is section or section #dihj;,d7g7 by su* issu]1 plan1 or entity4 7e7 ,def9itions ,9 ?is section3 7#a7 ,applicable entity ,! t]m applicable entity means-- 7,a7 an applicable gr\p pur*as+ organization1 drug manufactur]1 di/ributor1 :olesal]1 rebate aggregator 7or o!r pur*as+ entity design$ to aggregate rebates71 or associat$ ?ird p>ty2 7,b7 any subsidi>y1 p>5t1 affiliate1 or subcontractor ( a gr\p heal? plan1 heal? insurance issu]1 entity t provides ph>macy b5efit managem5t s]vices on behalf ( su* a plan or issu]1 or any entity describ$ 9 subp>agraph 7,a72 or 7,c7 su* o!r entity z ! ,secret>y may specify ?r\gh rulemak+4 7#b7 ,applicable gr\p pur*as+ organization ,! t]m applicable gr\p pur*as+ organization means a gr\p pur*as+ organization t is affiliat$ ) or "u common own]%ip ) an entity provid+ ph>macy b5efit managem5t s]vices4 7#c7 ,contract$ comp5sation ,! t]m contract$ comp5sation means ! sum ( any +r$i5t co/ & disp5s+ fee = a drug 7inclusive ( ! out-(-pocket co/s to ! p>ticipant or b5efici>y71 or ano!r analog\s comp5sation /ructure t ! ,secret>y may specify ?r\gh regulations4 7#d7 ,gross sp5d+ ,! t]m gross sp5d+1 ) respect to prescription drug b5efits "u a gr\p heal? plan1 means ! am\nt sp5t by a gr\p heal? plan on prescription drug b5efits1 calculat$ be=e ! application ( rebates1 fees1 alt]native disc\nts1 or o!r remun]ation4 7#e7 ,net sp5d+ ,! t]m net sp5d+1 ) respect to prescription drug b5efits "u a gr\p heal? plan1 means ! am\nt sp5t by a gr\p heal? plan on prescription drug b5efits1 calculat$ aft] ! application ( rebates1 fees1 alt]native disc\nts1 or o!r remun]ation4 7#f7 ,plan sponsor ,! t]m plan sponsor has ! mean+ giv5 su* t]m 9 section #c7af77;,b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #ajjb7af77;,b774 7#g7 ,remun]ation ,! t]m remun]ation has ! mean+ giv5 su* t]m by ! ,secret>y1 ?r\gh rulemak+1 :i* %all be reevaluat$ by ! ,secret>y e #e ye>s4 7#h7 ,specifi$ l>ge employ] ,! t]m specifi$ l>ge employ] means1 9 connection ) a gr\p heal? plan e/abli%$ or ma9ta9$ by a s+le employ]1 ) respect to a cal5d> ye> or a plan ye>1 z applicable1 an employ] :o employ$ an av]age ( at lea/ #ajj employees on bus9ess days dur+ ! prec$+ cal5d> ye> or plan ye> & :o employs at lea/ #a employee on ! fir/ day ( ! cal5d> ye> or plan ye>4 7#i7 ,specifi$ l>ge plan ,! t]m specifi$ l>ge plan means a gr\p heal? plan e/abli%$ or ma9ta9$ by a plan sponsor describ$ 9 clause 7ii7 or 7iii7 ( section #c7af77;,b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #ajjb7af77;,b77 t _h an av]age ( at lea/ #ajj p>ticipants on bus9ess days dur+ ! prec$+ cal5d> ye> or plan ye>1 z applicable4 7#aj7 ,:olesale acquisition co/ ,! t]m :olesale acquisition co/ has ! mean+ giv5 su* t]m 9 section #ahdg;,a7c77#f77;,b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b774 2 7#b7 ,exception = c]ta9 gr\p heal? plans ,section #ihca7;a77#b7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by ins]t+ o!r ?an ) respect to section #ihbf1 be=e any gr\p heal? plan4 7#c7 ,en=cem5t ,section #dihj;,d ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new subsection3 7g7 ,application to requirem5ts impos$ on c]ta9 entities provid+ ph>macy b5efit managem5t s]vices ,9 ! case ( any requirem5t "u section #ihbf t applies ) respect to an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( a gr\p heal? plan1 any ref]5ce 9 ?is section to su* gr\p heal? plan 7& ! ref]5ce 9 subsection 7e77#a7 to ! employ]7 %all be treat$ z includ+ a ref]5ce to su* entity4 4 7#d7 ,cl]ical am5dm5t ,! table ( sections = sub*apt] ,b ( *apt] #ajj ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new item3 ,sec4 #ihbf4 ,ov]sight ( entities t provide ph>macy b5efit managem5t s]vices44 #ijb4 ,full rebate pass ?r\gh to plan2 exception = innoc5t plan fiduci>ies 7a7 ,9 g5]al ,section #djh7;b77#b7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77 is am5d$-- 7#a7 9 subp>agraph 7,b77viii7-- 7,a7 by r$esignat+ subclauses 7,,ii7 ?r\gh 7,,iv7 z subclauses 7,,iii7 ?r\gh 7,v71 respectively2 7,b7 9 subclause 7,i7-- 7i7 by /rik+ subclause 7,,ii7 & ins]t+ subclause 7,,iii72 & 7ii7 by /rik+ subclauses 7,,ii7 & 7,,iii7 & ins]t+ subclauses 7,,iii7 & 7,,iv72 & 7,c7 by ins]t+ aft] subclause 7,i7 ! foll[+3 7,,ii7 ,pursuant to subsection 7a71 subp>agraphs 7,c7 & 7,d7 ( section #djf7;a77#a7 %all n apply to a responsible plan fiduci>y1 not)/&+ any failure to remit requir$ am\nts "u subp>agraph 7,c77i71 if ! foll[+ conditions are met3 7aa7 ,! responsible plan fiduci>y did n "k t ! cov]$ s]vice provid] fail$ or w\ld fail to make requir$ remittances & reasonably believ$ t ! cov]$ s]vice provid] remitt$ su* requir$ am\nts4 7bb7 ,! responsible plan fiduci>y1 ^u discov]+ t ! cov]$ s]vice provid] fail$ to remit ! requir$ am\nts1 reque/s 9 writ+ t ! cov]$ s]vice provid] remit su* am\nts4 7cc7 ,if ! cov]$ s]vice provid] fails to comply ) a writt5 reque/ describ$ 9 subclause 7,,iii7 )9 #ij days ( ! reque/1 ! responsible plan fiduci>y notifies ! ,secret>y ( ! cov]$ s]vice provid]'s failure1 9 accordance ) subclauses 7,,iii7 & 7,,iv74 2 & 7#b7 by add+ at ! end ! foll[+3 7,c7 7i7 7,i7 ,= plan ye>s beg9n+ on or aft] ! date t is #cj mon?s aft] ! date ( enactm5t ( ?is subp>agraph 7ref]r$ to 9 ?is clause z ! effective date71 no contract or arrangem5t or r5ewal or ext5sion ( a contract or arrangem5t1 ent]$ into on or aft] ! effective date1 = s]vices betwe5 a cov]$ plan & a cov]$ s]vice provid]1 ?r\gh a heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 a ?ird-p>ty adm9i/rator1 an entity provid+ ph>macy b5efit managem5t s]vices1 or o!r entity1 = ph>macy b5efit managem5t s]vices1 is reasonable )9 ! mean+ ( ?is p>agraph unless su* entity provid+ ph>macy b5efit managem5t s]vices-- 7aa7 remits #ajj p]c5t ( rebates1 fees1 alt]native disc\nts1 & o!r remun]ation receiv$ f any applicable entity t are relat$ to utilization ( drugs or drug sp5d+ "u su* heal? plan or heal? insurance cov]age1 to ! gr\p heal? plan or heal? insurance issu] (f]+ gr\p heal? insurance cov]age2 & 7bb7 does n ent] into any contract = ph>macy b5efit managem5t s]vices on behalf ( su* a plan or cov]age1 ) an applicable entity unless #ajj p]c5t ( rebates1 fees1 alt]native disc\nts1 & o!r remun]ation receiv$ "u su* contract t are relat$ to ! utilization ( drugs or drug sp5d+ "u su* gr\p heal? plan or heal? insurance cov]age are remitt$ to ! gr\p heal? plan or heal? insurance issu] by ! entity provid+ ph>macy b5efit managem5t s]vices4 7,,ii7 ,no?+ 9 subclause 7,i7 %all be con/ru$ to affect ! t]m ( a contract or arrangem5t1 z 9 effect on ! effective date 7z describ$ 9 su* subclause71 except t su* subclause %all apply to any r5ewal or ext5sion ( su* a contract or arrangem5t ent]$ into on or aft] su* effective date1 z s describ$4 7ii7 ,) respect to su* rebates1 fees1 alt]native disc\nts1 & o!r remun]ation-- 7,i7 ! rebates1 fees1 alt]native disc\nts1 & o!r remun]ation "u clause 7i77,i7 %all be-- 7aa7 remitt$-- 7,,aa7 on a qu>t]ly basis1 to ! gr\p heal? plan or ! gr\p heal? insurance issu]1 n lat] ?an #ij days aft] ! end ( ea* qu>t]2 or 7,,bb7 9 ! case ( an und]paym5t 9 a remittance = a prior qu>t]1 z soon z practicable1 b n lat] ?an #ij days aft] notice ( ! und]paym5t is fir/ giv52 7bb7 fully disclos$ & enum]at$ to ! gr\p heal? plan or heal? insurance issu]2 & 7cc7 return$ to ! cov]$ s]vice provid] = ph>macy b5efit managem5t s]vices on behalf ( ! gr\p heal? plan if any audit by a plan sponsor1 issu] or a ?ird p>ty designat$ by a plan sponsor1 indicates t ! am\nts receiv$ are incorrect aft] su* am\nts h be5 paid to ! gr\p heal? plan or heal? insurance issu]2 7,,ii7 ! ,secret>y may e/abli% proc$ures = ! remittance ( rebates fees1 alt]native disc\nts1 & o!r remun]ation "u subclause 7,i77aa7 & ! disclosure ( rebates1 fees1 alt]native disc\nts1 & o!r remun]ation "u subclause 7,i77bb72 & 7,,iii7 ! records ( su* rebates1 fees1 alt]native disc\nts1 & o!r remun]ation %all be available = audit by ! plan sponsor1 issu]1 or a ?ird p>ty designat$ by a plan sponsor1 n less ?an once p] plan ye>4 7iii7 ,to ensure t an entity provid+ ph>macy b5efit managem5t s]vices is able to meet ! requirem5ts ( clause 7ii77,i71 a rebate aggregator 7or o!r pur*as+ entity design$ to aggregate rebates7 & an applicable gr\p pur*as+ organization %all remit su* rebates to ! entity provid+ ph>macy b5efit managem5t s]vices n lat] ?an #de days aft] ! end ( ea* qu>t]4 7iv7 ,a ?ird-p>ty adm9i/rator ( a gr\p heal? plan1 a heal? insurance issu] (f]+ gr\p heal? insurance cov]age1 or a cov]$ s]vice provid] = ph>macy b5efit managem5t s]vices "u su* heal? plan or heal? insurance cov]age %all make rebate contracts ) rebate aggregators or drug manufactur]s available = audit by su* plan sponsor or designat$ ?ird p>ty1 subject to reasonable re/rictions 7z det]m9$ by ! ,secret>y7 on confid5tiality to prev5t re-disclosure ( su* contracts or use ( su* in=mation 9 audits = purposes unrelat$ to ?is section4 7v7 ,audits c>ri$ out "u clauses 7ii77,,iii7 & 7iv7 %all be p]=m$ by an auditor select$ by ! responsible plan fiduci>y4 ,paym5t = su* audits %all n be made1 :e!r directly or indirectly1 by ! entity provid+ ph>macy b5efit managem5t s]vices4 7vi7 ,no?+ 9 ?is subp>agraph %all be con/ru$ to-- 7,i7 prohibit reasonable paym5ts to entities (f]+ ph>macy b5efit managem5t s]vices = bona fide s]vices us+ a fee /ructure n describ$ 9 ?is subp>agraph1 provid$ t su* fees are transp>5t & quantifiable to gr\p heal? plans & heal? insurance issu]s2 7,,ii7 require a ?ird-p>ty adm9i/rator ( a gr\p heal? plan or cov]$ s]vice provid] = ph>macy b5efit managem5t s]vices "u su* heal? plan or heal? insurance cov]age to remit bona fide s]vice fees to ! gr\p heal? plan2 7,,iii7 limit ! ability ( a gr\p heal? plan or heal? insurance issu] to pass ?r\gh rebates1 fees1 alt]native disc\nts1 & o!r remun]ation to ! p>ticipant or b5efici>y2 or 7,,iv7 modify ! requirem5ts = ! creation1 receipt1 ma9t5ance1 or transmission ( protect$ heal? in=mation "u ! privacy regulations promulgat$ "u ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif 9 "p #afj & subp>ts ,a & ,e ( "p #afd ( title #de1 ,code ( ,f$]al ,regulations 7or successor regulations74 7vii7 ,= purposes ( ?is subp>agraph-- 7,i7 ! t]ms applicable entity & applicable gr\p pur*as+ organization h ! mean+s giv5 su* t]ms 9 section #gbf7;e72 7,,ii7 ! t]ms cov]$ plan1 cov]$ s]vice provid]1 & responsible plan fiduci>y h ! mean+s giv5 su* t]ms 9 subp>agraph 7,b72 & 7,,iii7 ! t]ms gr\p heal? insurance cov]age1 heal? insurance cov]age1 & heal? insurance issu] h ! mean+s giv5 su* t]ms 9 section #gcc4 4 7b7 ,rule ( con/ruction ,subclause 7,,ii77aa7 ( section #djh7;b77#b77;,b77viii7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77viii771 z am5d$ by subsection 7a71 %all n be con/ru$ to relieve or limit a responsible plan fiduci>y f ! duty to monitor ! practices ( any cov]$ s]vice provid] t contracts ) ! applicable cov]$ plan1 includ+ = ! purposes ( ensur+ ! reasonabl5ess ( comp5sation4 ,= purposes ( ?is subsection1 ! t]ms cov]$ plan1 cov]$ s]vice provid]1 & responsible plan fiduci>y h ! mean+s giv5 su* t]ms 9 section #djh7;b77#b77;,b77ii7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77ii774 7c7 ,cl>ification ( cov]$ s]vice provid] 7#a7 ,s]vices 7,a7 ,9 g5]al ,section #djh7;b77#b77;,b77ii77,i77bb7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77ii77,i77bb77 is am5d$-- 7i7 9 subitem 7,,aa7 by /rik+ ,brok]age s]vices1 & ins]t+ ,s]vices 7includ+ brok]age s]vices712 & 7ii7 9 subitem 7,,bb7-- 7,i7 by /rik+ ,consult+1 & ins]t+ ,o!r s]vices12 & 7,,ii7 by /rik+ relat$ to ! developm5t or implem5tation ( plan design & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ includ+ any ( ! foll[+3 plan design1 insurance or insurance product selection 7includ+ vision & d5tal71 recordkeep+1 m$ical managem5t1 b5efits adm9i/ration selection 7includ+ vision & d5tal71 /op-loss insurance1 ph>macy b5efit managem5t s]vices1 wellness design & managem5t s]vices1 transp>5cy tools1 gr\p pur*as+ organization agreem5ts & s]vices1 p>ticipation 9 & s]vices f pref]r$ v5dor panels1 disease managem5t1 compliance s]vices1 employee assi/ance programs1 or ?ird-p>ty adm9i/ration s]vices1 or consult+ s]vices relat$ to any su* s]vices44 7,b7 ,s5se ( ,congress ,x is ! s5se ( ,congress t ! am5dm5t made by subp>agraph 7,a7 cl>ifies ! exi/+ requirem5t ( cov]$ s]vice provid]s ) respect to s]vices describ$ 9 section #djh7;b77#b77;,b77ii77,i77bb77,,bb7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77ii77,i77bb77,,bb77 t 7 9 effect s9ce ! application date describ$ 9 section #bjb7;e7 ( ! ,no ,surprises ,act 7,public ,law #aaf-bfj2 #bi ,u4,s4,c4 #aajh note71 & does n impose any additional requirem5t "u section #djh7;b77#b77;,b7 ( su* ,act4 7#b7 ,c]ta9 arrangem5ts = ph>macy b5efit managem5t s]vices consid]$ z indirect 7,a7 ,9 g5]al ,section #djh7;b77#b77;,b77i7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77i77 is am5d$-- 7i7 by /rik+ requirem5ts ( ?is clause & ins]t+ requirem5ts ( ?is subp>agraph2 & 7ii7 by add+ at ! end ! foll[+3 ,= purposes ( apply+ section #djf7;a77#a77;,c7 ) respect to a transaction describ$ "u ?is subp>agraph or subp>agraph 7,c71 a contract or arrangem5t = s]vices betwe5 a cov]$ plan & an entity provid+ s]vices to ! plan1 includ+ a heal? insurance issu] provid+ heal? insurance cov]age 9 connection ) ! cov]$ plan1 9 :i* su* entity contracts1 9 connection ) su* plan1 ) a s]vice provid] = ph>macy b5efit managem5t s]vices1 %all be consid]$ an indirect furni%+ ( goods1 s]vices1 or facilities betwe5 ! cov]$ plan & ! s]vice provid] = ph>macy b5efit managem5t s]vices act+ z ! p>ty 9 int]e/44 7,b7 ,heal? insurance issu] & heal? insurance cov]age def9$ ,section #djh7;b77#b77;,b77ii77,i77aa7 ( su* ,act 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77ii77,i77aa77 is am5d$ by ins]t+ be=e ! p]iod at ! end & ! t]ms heal? insurance cov]age & heal? insurance issu] h ! mean+s giv5 su* t]ms 9 section #gcc7;b74 7,c7 ,te*nical am5dm5t ,section #djh7;b77#b77;,b77ii77,i77aa7 ( ! ,employee ,retirem5t ,income ,security ,act ( #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77ii77,i77aa77 is am5d$ by ins]t+ 9 aft] def9$4 #ijc4 ,increas+ transp>5cy 9 g5]ic drug applications 7a7 ,9 g5]al ,section #eje7;j77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#c77 is am5d$ by add+ at ! end ! foll[+3 7,h7 7i7 ,^u reque/ 79 controll$ correspond5ce or an analog\s process7 by a p]son t has submitt$ or int5ds to submit an abbreviat$ application "u ?is subsection = a drug t is requir$ by regulation to conta9 "o or m ( ! same inactive +r$i5ts 9 ! same conc5trations z ! li/$ drug ref]r$ to1 or = :i* ! ,secret>y det]m9es !re is a sci5tific ju/ification = an approa* t is 9 vitro1 9 :ole or 9 "p1 to be us$ to demon/rate bioequival5ce = a drug if su* a drug conta9s "o or m ( ! same inactive +r$i5ts 9 ! same conc5trations z ! li/$ drug ref]r$ to1 ! ,secret>y %all in=m ! p]son :e!r su* drug is qualitatively & quantitatively ! same z ! li/$ drug4 ,! ,secret>y may also provide su* in=mation to su* a p]son on ! ,secret>y's own initiative dur+ ! review ( an abbreviat$ application "u ?is subsection = su* drug4 7ii7 ,not)/&+ section #cja7;j71 if ! ,secret>y det]m9es t su* drug is n qualitatively or quantitatively ! same z ! li/$ drug1 ! ,secret>y %all id5tify & disclose to ! p]son-- 7,i7 ! +r$i5t or +r$i5ts t cause su* drug n to be qualitatively or quantitatively ! same z ! li/$ drug2 & 7,,ii7 = any +r$i5t = :i* !re is an id5tifi$ quantitative deviation1 ! am\nt ( su* deviation4 7iii7 ,if ! ,secret>y det]m9es t su* drug is qualitatively & quantitatively ! same z ! li/$ drug1 ! ,secret>y %all n *ange or resc9d su* det]m9ation aft] ! submission ( an abbreviat$ application = su* drug "u ?is subsection unless-- 7,i7 ! =mulation ( ! li/$ drug has be5 *ang$ & ! ,secret>y has det]m9$ t ! prior li/$ drug =mulation 0 )drawn = reasons ( safety or effectiv5ess2 or 7,,ii7 ! ,secret>y makes a writt5 det]m9ation t ! prior det]m9ation mu/ be *ang$ because an error has be5 id5tifi$4 7iv7 ,if ! ,secret>y makes a writt5 det]m9ation describ$ 9 clause 7iii77,,ii71 ! ,secret>y %all provide notice & a copy ( ! writt5 det]m9ation to ! p]son mak+ ! reque/ "u clause 7i74 7v7 ,! disclosures au?oriz$ "u clauses 7i7 & 7ii7 are disclosures au?oriz$ by law1 includ+ = purposes ( section #aije ( title #ah1 ,unit$ ,/ates ,code4 ,?is subp>agraph %all n o!rwise be con/ru$ to au?orize ! disclosure ( nonpublic qualitative or quantitative in=mation ab\t ! +r$i5ts 9 a li/$ drug1 or to affect ! /atus1 if any1 ( su* in=mation z trade secret or confid5tial comm]cial in=mation = purposes ( section #cja7;j7 ( ?is ,act1 section #eeb ( title #e1 ,unit$ ,/ates ,code1 or section #aije ( title #ah1 ,unit$ ,/ates ,code4 4 7b7 ,guidance 7#a7 ,9 g5]al ,n lat] ?an "o ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue draft guidance1 or update guidance1 describ+ h[ ! ,secret>y w det]m9e :e!r a drug is qualitatively & quantitatively ! same z ! li/$ drug 7z su* t]ms are us$ 9 section #eje7;j77#c77;,h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a771 includ+ ) respect to assess+ p,h adju/]s4 7#b7 ,process ,9 issu+ guidance "u ?is subsection1 ! ,secret>y ( ,heal? & ,human ,s]vices %all-- 7,a7 publi% draft guidance2 7,b7 provide a p]iod ( at lea/ #fj days = comm5t on ! draft guidance2 & 7,c7 aft] consid]+ any comm5ts receiv$ & n lat] ?an "o ye> aft] ! close ( ! comm5t p]iod on ! draft guidance1 publi% f9al guidance4 7c7 ,applicability ,section #eje7;j77#c77;,h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a71 applies beg9n+ on ! date ( enactm5t ( ?is ,act1 irrespective ( ! date on :i* ! guidance requir$ by subsection 7b7 is f9aliz$4 #ijd4 ,title #ce am5dm5ts 7a7 ,9 g5]al ,section #bga7;e7 ( title #ce1 ,unit$ ,/ates ,code1 is am5d$-- 7#a7 9 p>agraph 7#b77;,c71 9 ! flu% text foll[+ clause 7ii71 by add+ at ! end ! foll[+3 ,) respect to a submission describ$ 9 clause 7ii71 ! act ( infr+em5t %all ext5d to any pat5t t claims ! biological product1 a me?od ( us+ ! biological product1 or a me?od or product us$ to manufacture ! biological product42 & 7#b7 by add+ at ! end ! foll[+3 7#g7 7,a7 ,subject to subp>agraphs 7,c71 7,d71 & 7,e71 if ! sponsor ( an approv$ application = a ref]5ce product1 z def9$ 9 section #cea7;i7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;i77 7ref]r$ to 9 ?is p>agraph z ! ref]5ce product sponsor71 br+s an action = infr+em5t "u ?is section aga9/ an applicant = approval ( a biological product "u section #cea7k7 ( su* ,act t ref]5ces t ref]5ce product 7ref]r$ to 9 ?is p>agraph z ! subsection 7k7 applicant71 ! ref]5ce product sponsor may ass]t 9 ! action a total ( n m ?an #bj pat5ts ( ! type describ$ 9 subp>agraph 7,b71 n m ?an #aj ( :i* %all h issu$ aft] ! date specifi$ 9 section #cea7l77#g77;,a7 ( su* ,act4 7,b7 ,! pat5ts describ$ 9 ?is subp>agraph are pat5ts t satisfy ea* ( ! foll[+ requirem5ts3 7i7 ,pat5ts t claim ! biological product t is ! subject ( an application "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77 7or a use ( t product7 or a me?od or product us$ 9 ! manufacture ( su* biological product4 7ii7 ,pat5ts t are includ$ on ! li/ ( pat5ts describ$ 9 p>agraph 7#c77;,a7 ( section #cea7l7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7l771 includ+ z provid$ "u p>agraph 7#g7 ( su* section #cea7l74 7iii7 ,pat5ts t-- 7,i7 h an actual fil+ date ( m ?an #d ye>s aft] ! date on :i* ! ref]5ce product is approv$2 or 7,,ii7 include a claim to a me?od 9 a manufactur+ process t is n us$ by ! ref]5ce product sponsor4 7,c7 ,! c\rt 9 :i* an action describ$ 9 subp>agraph 7,a7 is br\ght may increase ! numb] ( pat5ts limit$ "u t subp>agraph-- 7i7 if ! reque/ to increase t numb] is made )\t undue delay2 & 7ii7 7,i7 if ! int]e/ ( ju/ice s requires2 or 7,,ii7 = good cause %[n1 :i*-- 7aa7 %all be e/abli%$ if ! subsection 7k7 applicant fails to provide in=mation requir$ section #cea7k77#b77;,a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77#b77;,a77 t w\ld enable ! ref]5ce product sponsor to =m a reasonable belief ) respect to :e!r a claim ( infr+em5t "u ?is section c\ld reasonably be ass]t$2 & 7bb7 may be e/abli%$-- 7,,aa7 if !re is a mat]ial *ange to ! biological product 7or process ) respect to ! biological product7 ( ! subsection 7k7 applicant t is ! subject ( ! application2 7,,bb7 if1 ) respect to a pat5t on ! supplem5tal li/ describ$ 9 section #cea7l77#g77;,a7 ( ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7l77#g77;,a771 ! pat5t w\ld h issu$ be=e ! date specifi$ 9 su* section #cea7l77#g77;,a7 b = ! failure ( ! ,(fice to issue ! pat5t or a delay 9 ! issuance ( ! pat5t1 z describ$ 9 p>agraph 7#a7 ( section #aed7;b7 & subject to ! limitations "u p>agraph 7#b7 ( su* section #aed7;b72 or 7,,cc7 = ano!r reason t %[s good cause1 z det]m9$ appropriate by ! c\rt4 7,d7 ,9 det]m9+ :e!r good cause has be5 %[n = ! purposes ( subp>agraph 7,c77ii77,,ii71 a c\rt may consid] :e!r ! ref]5ce product sponsor has provid$ a reasonable description ( ! id5tity & relevance ( any in=mation beyond ! subsection 7k7 application t ! c\rt believes is necess>y to enable ! c\rt to =m a belief ) respect to :e!r a claim ( infr+em5t "u ?is section c\ld reasonably be ass]t$4 7,e7 ,! limitation impos$ "u subp>agraph 7,a7-- 7i7 %all apply only if ! subsection 7k7 applicant completes all actions requir$ "u p>agraphs 7#b77;,a71 7#c77;,b77ii71 7#e71 7#f77;,c77i71 7#g71 & 7#h77;,a7 ( section #cea7l7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7l772 & 7ii7 %all n apply ) respect to any pat5t t claims1 ) respect to a biological product1 a me?od = us+ t product 9 !rapy1 diagnosis1 or prophylaxis1 su* z an indication or me?od ( treatm5t or o!r condition ( use4 4 7b7 ,applicability ,! am5dm5ts made by subsection 7a7 %all apply ) respect to an application submitt$ "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77 on or aft] ! date ( enactm5t ( ?is ,act4 ,x ,miscellane\s #ajja4 ,ext5sion ( safe h>bor = abs5ce ( d$uctible = teleheal? ,section #bbc7;c77#b77;,e77ii7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ to read z foll[s3 7ii7 ,safe h>bor = abs5ce ( d$uctible = teleheal? 7,i7 ,9 g5]al ,9 ! case ( an eligible mon? or an eligible plan ye>1 a plan %all n fail to be treat$ z a high d$uctible heal? plan by reason ( fail+ to h a d$uctible = teleheal? & o!r remote c>e s]vices4 7,,ii7 ,eligible mon? ,= purposes ( ?is clause1 ! t]m eligible mon? means mon?s beg9n+ aft] ,m>* #ca1 #bjbb1 & be=e ,janu>y #a1 #bjbc1 & mon?s beg9n+ aft] ,m>* #ca1 #bjbe1 & be=e ,janu>y #a1 #bjbf4 7,,iii7 ,eligible plan ye> ,= purposes ( ?is clause1 ! t]m eligible plan ye> means plan ye>s beg9n+-- 7aa7 on or be=e ,decemb] #ca1 #bjba1 7bb7 aft] ,decemb] #ca1 #bjbb1 & be=e ,janu>y #a1 #bjbe1 or 7cc7 aft] ,decemb] #ca1 #bjbd1 & be=e ,janu>y #a1 #bjbg4 4