,i #aai? ,,congress #a/ ,session ,h4 ,r4 #ebef ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,septemb] #aj1 #bjbe ,mr4 ,c>t] ( ,georgia 7= himself & ,mrs4 ,h>%b>g]7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committee on ,ways & ,means1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to am5d ! ,public ,heal? ,s]vice ,act to re=m ! #cdj;,b drug pric+ program1 & = o!r purposes4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! #cdj;,b ,af=d+ ,c>e = ,communities & ,ensur+ a ,/rong ,safety-net ,act or ! #cdj;,b ,,access ,act4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4 ,sec4 #b4 ,def9itions4 ,sec4 #c4 ,prev5tion ( ,m$icaid duplicate disc\nts2 ov]sight ( cov]$ entities4 ,sec4 #d4 ,hospital *ild site requirem5ts4 ,sec4 #e4 ,contract ph>macies4 ,sec4 #f4 ,ensur+ pati5t af=dability ( drugs pur*as$ "u section #cdj;,b4 ,sec4 #g4 ,requirem5ts = nonhospital cov]$ entities & subgrantees4 ,sec4 #h4 ,claims modifi]s2 cov]$ entity data submission4 ,sec4 #i4 ,cov]$ entity report+ on scope ( grant1 contract1 & project4 ,sec4 #aj4 ,ensur+ cov]$ entity transp>5cy4 ,sec4 #aa4 ,revisions to exi/+ #cdj;,b hospital eligibility requirem5ts4 ,sec4 #ab4 ,additional requirem5ts = #cdj;,b hospitals4 ,sec4 #ac4 #cdj;,b program4 ,sec4 #ad4 ,audits ( private nonhospital contracts ) ,/ate & local gov]nm5ts4 ,sec4 #ae4 ,ensur+ cov]$ entity compliance ) transp>5cy requirem5ts4 ,sec4 #af4 #cdj;,b claims data cle>+h\se4 ,sec4 #ag4 ,limitation on adm9i/rator s]vice fees & contract ph>macy fees4 ,sec4 #ah4 ,cl>ification4 ,sec4 #ai4 ,ensur+ ! equitable treatm5t ( #cdj;,b cov]$ entities & ph>macies p>ticipat+ 9 ! #cdj;,b drug disc\nt program4 ,sec4 #bj4 ,effective date4 #b4 ,def9itions 7a7 ,def9ition ( pati5t ,section #cdj;,b7b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7b77 is am5d$ by add+ at ! end ! foll[+3 7#c7 ,pati5t 7,a7 ,9 g5]al ,9 ?is section1 ! t]m pati5t means1 ) respect to a cov]$ entity describ$ 9 subsection 7a77#d71 an individual :o1 on a prescription-by-prescription or ord]-by-ord] basis-- 7i7 is disp5s$ or adm9i/]$ a cov]$ outpati5t drug t is-- 7,i7 directly relat$ to ! s]vice describ$ 9 clause 7iii72 7,,ii7 ord]$ or prescrib$ by a cov]$ entity provid] describ$ 9 clause 7ii7 z a result ( ! s]vice describ$ 9 clause 7iii72 & 7,,iii7 disp5s$ or adm9i/]$ on site at a cov]$ entity location1 a *ild site 7z def9$ 9 subsection 7a77#e77;,e771 or an entity ph>macy 7z def9$ 9 subsection 7a77#e77;,f77 li/$ 9 ! id5tification sy/em describ$ 9 subsection 7d77#b77;,b77iv71 or on site at a contract ph>macy 9 accordance ) subsection 7a77#e77;,f7 or disp5s$ ?r\gh a mail ord] ph>macy 9 accordance ) subsection 7a77#e77;,f72 7ii7 receives ! heal? c>e s]vice describ$ 9 clause 7iii7 f a cov]$ entity provid]1 mean+ a heal? c>e pr(essional :o ei!r-- 7,i7 is an employee or indep5d5t contractor ( ! cov]$ entity1 su* t ! cov]$ entity bills = s]vices furni%$ by ! heal? c>e pr(essional & is responsible = ! c>e furni%$ by su* pr(essional2 or 7,,ii7 furni%es heal? c>e s]vices "u an ongo+ contractual obligation to ! cov]$ entity su* t responsibility = ! c>e provid$ rema9s ) ! cov]$ entity & meets ! o!r requirem5ts 9 ?is p>agraph1 9 ! ev5t ,/ate law prohibits or o!rwise sub/antially limits ! ability ( ! cov]$ entity to bill = s]vices ( ! heal? c>e pr(essional2 7iii7 receives a cov]$ outpati5t drug 9 connection ) a heal? c>e s]vice furni%$ at ! cov]$ entity 7includ+ a *ild site7 & su* drug & s]vice are paid by ! insur] or ?ird-p>ty payor z outpati5t items & s]vices 7or :]e ?ird-p>ty reimbursem5t is n made1 su* items & s]vices are deem$ outpati5t if less ?an #bd h\rs h elaps$ betwe5 su* individual's hospital regi/ration & dis*>ge72 7iv7 is describ$ 9 a category ( individuals )9 ! scope (1 & receives a heal? c>e s]vice at ! cov]$ entity 7includ+ a *ild site7 t is )9 ! scope (-- 7,i7 ! ,f$]al grant1 project1 or ,f$]al grant-au?oriz+ /atute1 z applicable1 t qualifies su* entity = p>ticipation 9 ! program "u ?is section1 if ! cov]$ entity is describ$ 9 "o ( subp>agraphs 7,a7 ?r\gh 7,k7 ( subsection 7a77#d72 or 7,,ii7 ! contract z requir$ 9 p>agraphs 7#d77,l77i7 & 7#aa7 ( subsection 7a71 if ! cov]$ entity is a private nonpr(it hospital :i* has1 z ! basis = p>ticipat+ 9 ! program "u ?is section1 a contract ) a ,/ate or local gov]nm5t to provide heal? c>e s]vices to specifi$ individuals1 provid$ t clause 7iv7 %all n apply ) respect to a cov]$ entity describ$ 9 subsection 7a77#d77,n7 or a sole community hospital describ$ 9 subsection 7a77#d77,o72 & 7v7 has an ongo+ relation%ip ) ! cov]$ entity su* t ! cov]$ entity creates & ma9ta9s auditable heal? c>e records :i* demon/rate compliance ) ?is p>agraph & t ! cov]$ entity-- 7,i7 has a provid]-to-pati5t relation%ip ) ! individual2 7,,ii7 is responsible = ! individual's heal? c>e s]vice t result$ 9 ! prescription or ord] = ! drug2 & 7,,iii7 7aa7 has provid$ a heal? c>e s]vice to ! individual ?r\gh an 9-p]son visit )9 ! pa/ #ab mon?s1 if ! cov]$ entity is a hospital describ$ 9 subp>agraph 7,l7 or subp>agraph 7,m7 ( subsection 7a77#d7 or is a rural ref]ral c5t] describ$ 9 subp>agraph 7,o7 ( su* subsection2 or 7bb7 has provid$ a heal? c>e s]vice to ! individual ?r\gh an 9-p]son visit )9 ! pa/ #bd mon?s1 if ! cov]$ entity is describ$ 9 "o ( subp>agraphs 7,a7 ?r\gh 7,k7 ( subsection 7a77#d71 subp>agraph 7,n7 ( su* subsection1 or is a sole community hospital describ$ 9 subp>agraph 7,o7 ( su* subsection4 7,b7 ,teleheal? & telem$ic9e 7i7 ,9 g5]al ,a prescription = a cov]$ outpati5t drug result+ f a heal? c>e s]vice furni%$ to an individual ?r\gh teleheal?1 telem$ic9e1 or o!r remote heal? c>e s]vice arrangem5ts %all n qualify = pric+ describ$ 9 subsection 7a77#a7 unless-- 7,i7 ! cov]$ entity 7includ+ *ild site1 z applicable7 at :i* su* s]vice is furni%$ is a cov]$ entity 7or a *ild site ( a cov]$ entity1 z applicable7 describ$ 9 "o ( subp>agraphs 7,a7 ?r\gh 7,k7 ( subsection 7a77#d71 subp>agraph 7,n7 ( su* subsection1 or is a sole community hospital describ$ 9 subp>agraph 7,o7 ( su* subsection2 & 7,,ii7 subject to ! exception 9 clause 7ii71 a cov]$ entity provid] has conduct$ an 9-p]son exam9ation ( ! individual )9 ! #f-mon? "t p]iod imm$iately prec$+ ! heal? c>e s]vice result+ 9 ! prescription or ord] = ! drug4 7ii7 ,exception ,! requirem5t 9 clause 7i77,,ii7 %all n apply ) respect to an individual = :om ! cov]$ entity ma9ta9s auditable records suffici5t to demon/rate t su* entity v]ifi$ su* individual is det]m9$ eligible = b5efits "u ei!r title ,,ii ( ! ,social ,security ,act or title ,,xvi ( su* ,act 9 accordance ) ! provisions ( su* applicable title4 7,c7 ,prescriptions f non-cov]$ entity provid]s ineligible 7i7 ,9 g5]al ,subject to ! exception = c>e coord9ation describ$ 9 clause 7ii71 a cov]$ outpati5t drug prescrib$ or ord]$ = an individual by a heal? c>e pr(essional :o is n a cov]$ entity provid] %all n qualify = pric+ describ$ 9 subsection 7a77#a74 7ii7 ,exception = c>e coord9ation ,9 ! case ( a cov]$ outpati5t drug prescrib$ or ord]$ = an individual result+ f c>e coord9ation provid$ by ! cov]$ entity1 all requirem5ts 9 subp>agraph 7,a7 %all apply1 except = clauses 7i77,i71 7i77,,ii71 7ii71 7iii71 & 7v77,,ii7 ( su* subp>agraph4 ,= purposes ( ?is p>agraph1 c>e coord9ation %all ref] to ! sequ5ce ( occurr5ces describ$ 9 ?is clause = :i* a cov]$ entity ma9ta9s docum5tation suffici5t to demon/rate t-- 7,i7 a cov]$ entity provid] evaluates & recomm5ds to ! individual1 dur+ an enc\nt] at ! cov]$ entity 7includ+ *ild site1 z applicable71 t su* individual receive a specifi$ type ( specialty heal? c>e n available at ! cov]$ entity & su* recomm5dation is contemporane\sly docum5t$1 at ! "t ( su* enc\nt]1 9 ! m$ical record ! cov]$ entity creates & ma9ta9s = su* individual2 7,,ii7 )9 "o ye> ( ! date ( ! enc\nt] & recomm5dation describ$ 9 subclause 7,i71 ! individual receives a heal? c>e s]vice f a m$ical speciali/ ( ! type describ$ 9 su* recomm5dation2 7,,iii7 )9 ! "t p]iod specifi$ 9 subclause 7,,ii71 ! cov]$ entity provid] mak+ ! recomm5dation receives1 directly f ! m$ical speciali/ t furni%es ! heal? c>e s]vice describ$ 9 subclause 7,,ii71 writt5 docum5tation specify+ ! s]vice or s]vices furni%$ to su* individual & ! diagnoses made 9 connection ) su* s]vice or s]vices2 & 7,,iv7 ! cov]$ entity reta9s ov]all responsibility = ! c>e ( ! individual4 7iii7 ,cov]$ entity eligibility = c>e coord9ation ,not)/&+ any o!r provision 9 ?is section1 a cov]$ entity %all n qualify = pric+ describ$ 9 subsection 7a77#a7 ) respect to a prescription or ord] = a cov]$ outpati5t drug result+ f c>e coord9ation provid$ by ! cov]$ entity unless su* cov]$ entity-- 7,i7 is describ$ 9 subp>agraph 7,n7 ( subsection 7a77#d72 7,,ii7 is a sole community hospital describ$ 9 subp>agraph 7,o7 ( su* subsection2 or 7,,iii7 is describ$ 9 "o ( subp>agraphs 7,a7 ?r\gh 7,k7 ( su* subsection1 is n a specifi$ nonhospital cov]$ entity 7z def9$ 9 subsection 7b77#d771 & has a ,f$]al grant t requires su* entity to contract or ref] = ! heal? c>e s]vice or s]vices furni%$ to ! individual by ! m$ical speciali/ describ$ 9 clause 7ii74 7,d7 ,heal? c>e s]vice requir$ ,= purposes ( ?is section1 an individual %all n be consid]$ a pati5t ( ! cov]$ entity describ$ 9 subsection 7a77#d7 if ! individual receives f ! cov]$ entity only ! adm9i/ration or infusion ( a drug or drugs1 or ! disp5s+ ( a drug or drugs = subsequ5t self-adm9i/ration or adm9i/ration 9 ! home sett+1 )\t a cov]$ entity provid]-to-pati5t enc\nt] involv+ ! provision ( a heal? c>e s]vice4 4 7b7 ,def9ition ( specifi$ nonhospital cov]$ entity ,section #cdj;,b7b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7b77 is fur!r am5d$ by add+ at ! end ! foll[+3 7#d7 ,specifi$ nonhospital cov]$ entity ,9 ?is section1 ! t]m specifi$ nonhospital cov]$ entity means a cov]$ entity t-- 7,a7 is describ$ 9 "o ( subp>agraphs 7,b7 ?r\gh 7,k7 ( subsection 7a77#d71 o!r ?an a cov]$ entity describ$ 9 subp>agraph 7,g7 ( su* subsection1 &-- 7i7 has av]age annual op]at+ rev5ues exce$+ #a1jjj1jjj1jjj calculat$ ov] ! mo/ rec5t ?ree-ye> p]iod = :i* data are available1 :i* rev5ue ?re%old %all be adju/$ = inflation annually to reflect rate ( *ange 9 ! ,consum] ,price ,index = ,all ,urban ,consum]s publi%$ by ! ,bureau ( ,labor ,/ati/ics2 or 7ii7 is an affiliate ( a hospital2 or 7,b7 is describ$ 9 subsection 7a77#d77;,a7 & becomes affiliat$ ) a hospital on or aft] ,decemb] #a1 #bjbd4 ,= purposes ( ?is def9ition1 ! t]m affiliate %all mean an entity t1 directly or indirectly1 controls1 is controll$ by1 or is "u common control ) ! ref]5c$ entity1 includ+ ! ref]5c$ entity's p>5t1 & ! t]m control %all mean ! p[] to direct ! managem5t & policies ( an entity1 directly or indirectly1 :e!r ?r\gh ! own]%ip ( vot+ securities1 by contract1 or o!rwise4 4 #c4 ,prev5tion ( ,m$icaid duplicate disc\nts2 ov]sight ( cov]$ entities ,section #cdj;,b7a77#e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77#e77 is am5d$-- 7#a7 9 subp>agraph 7,a7-- 7,a7 9 clause 7ii71 by /rik+ ,! ,secret>y & ins]t+ ,subject to subsection 7d77#b77;,c71 ! ,secret>y2 & 7,b7 by add+ at ! end ! foll[+3 7iii7 ,regulations ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is clause1 ! ,secret>y %all promulgate f9al regulations ?r\gh notice-&-comm5t rulemak+ describ+-- 7,i7 me?odologies ,/ate ,m$icaid programs & all cov]$ entities "u subsection 7a77#d71 & _! contract ph>macies1 %all use to id5tify & bill drugs pur*as$ "u ! #cdj;,b program 9 a mann] t ensures compliance ) applicable prohibitions reg>d+ duplicate disc\nts or rebates1 includ+ ! duplicate disc\nt prohibition "u ?is subp>agraph & ! prohibitions "u sections #aibg7;j77#a7 & #aijc7m77#b77;,a77xiii7 ( ! ,social ,security ,act1 to include ! application ( su* prohibitions to #cdj;,b drugs us$ by ,m$icaid manag$ c>e enrollees2 & 7,,ii7 proc$ures ,/ate ,m$icaid programs %all use to exclude reque/s = ,m$icaid rebates on cov]$ outpati5t drugs pur*as$ "u ! #cdj;,b program t are disp5s$1 adm9i/]$1 or o!rwise furni%$ to a ,m$icaid manag$ c>e enrollee & requirem5ts = ,/ate ,m$icaid programs to promulgate rules to provide affect$ manufactur]s a prompt rem$y ) respect to any incorrectly bill$ rebates = su* drugs4 2 7#b7 9 subp>agraph 7,c7-- 7,a7 by /rik+ ,a cov]$ entity %all p]mit & ins]t+3 7i7 ,duplicate disc\nts & drug resale ,a cov]$ entity %all p]mit 2 7,b7 by /rik+ 7,a7 or 7,b7 & ins]t+ 7,a71 7,b71 7,j71 or 7,k72 & 7,c7 by add+ at ! end ! foll[+3 7ii7 ,use ( m>g9 ,a cov]$ entity %all p]mit ! ,secret>y to audit1 at ! ,secret>y's exp5se1 ! records ( ! entity to det]m9e-- 7,i7 h[ ! m>g9 7z def9$ 9 subp>agraph 7,l77iv77 g5]at$ on cov]$ outpati5t drugs subject to an agreem5t "u ?is section disp5s$ or furni%$ by su* entity 7or a contract ph>macy describ$ 9 subsection 7a77#e77;,f77 is us$ by su* entity2 & 7,,ii7 su* entity's compliance ) subp>agraph 7,l74 7iii7 ,records ret5tion ,cov]$ entities %all reta9 su* records & provide su* records & reports z det]m9$ necess>y by ! ,secret>y = c>ry+ out ?is subp>agraph4 2 & 7#c7 9 subp>agraph 7,d71 by /rik+ 7,a7 or 7,b7 & ins]t+ 7,a71 7,b71 7,j71 or 7,k74 #d4 ,hospital *ild site requirem5ts 7a7 ,hospital *ild site requirem5ts ,section #cdj;,b7a77#e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77#e77 is am5d$ by add+ at ! end ! foll[+3 7,e7 ,hospital *ild site requirem5ts 7i7 ,9 g5]al ,a cov]$ entity describ$ 9 "o ( subp>agraphs 7,l7 ?r\gh 7,o7 ( p>agraph 7#d7 may regi/] an (f-campus outpati5t facility associat$ ) su* cov]$ entity = inclusion 9 ! id5tification sy/em describ$ 9 subsection 7d77#b77;,b77iv7 to p>ticipate 9 ! program "u ?is section z an integral "p ( su* cov]$ entity if su* cov]$ entity demon/rates to ! ,secret>y1 9 a mann] specifi$ by ! ,secret>y1 t su* facility satisfies ea* ( ! requirem5ts 9 ?is subp>agraph4 ,= purposes ( ?is section1 ea* facility regi/]$ to p>ticipate 9 ! program "u ?is section & satisfy+ ! requirem5ts 9 ?is subp>agraph %all be ref]r$ to z a *ild site4 7,i7 ,! facility is li/$ on ! cov]$ entity's mo/ rec5tly fil$ ,m$ic>e co/ report on a l9e t is reimbursable "u ! ,m$ic>e program 7or1 if ! cov]$ entity is a *ildr5's hospital t does n file a ,m$ic>e co/ report1 ! cov]$ entity submits to ! ,secret>y a sign$ /atem5t c]tify+ t ! facility w\ld be correctly includ$ on a reimbursable l9e ( a ,m$ic>e co/ report if ! cov]$ entity fil$ a co/ report74 7,,ii7 ,su* co/ report demon/rates t ! s]vices provid$ at ! facility h associat$ co/s & *>ges = hospital outpati5t dep>tm5t s]vices "u title ,,xviii ( ! ,social ,security ,act 7or1 if ! cov]$ entity is a *ildr5's hospital t does n file a ,m$ic>e co/ report1 ! cov]$ entity submits to ! ,secret>y a sign$ /atem5t c]tify+ t ! s]vices provid$ at ! facility include outpati5t s]vices74 7,,iii7 ,! facility is :olly own$ by ! cov]$ entity4 7,,iv7 ,! ,secret>y has made a det]m9ation1 "u ! process describ$ 9 section #dac4fe7;b7 ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulations71 t ! facility meets ! ,m$ic>e provid]-bas$ /&>ds "u section #dac4fe ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulations7 = an (f-campus outpati5t dep>tm5t ( ! cov]$ entity4 7,v7 ,! facility provides outpati5t heal? c>e s]vices t are n limit$ to only disp5s+1 adm9i/]+1 or o!rwise furni%+ cov]$ outpati5t drugs4 7,,vi7 ,! facility is subject to & adh]es to all *>ity c>e & slid+ fee scale policies ( ! cov]$ entity & makes su* policies publicly available 9 a mann] consi/5t ) requirem5ts e/abli%$ "u section #eja7r7 ( ! ,int]nal ,rev5ue ,code ( #aihf applicable to hospital f9ancial assi/ance policies4 7,,vii7 ,! facility is locat$ 9 an area ) a %ortage ( p]sonal heal? s]vices t is-- 7aa7 initially designat$ by ! ,secret>y pursuant to section #bed;b7b77#c7 ( title #db1 ,unit$ ,/ates ,code1 on or be=e ,decemb] #a1 #bjbd2 or 7bb7 designat$ by ! ,secret>y pursuant to subp>agraphs 7,a7 ?r\gh 7,c7 ( section #bed;b7b77#c7 ( title #db1 ,unit$ ,/ates ,code1 aft] ,decemb] #a1 #bjbd1 us+ ! scor+ me?odology & crit]ia specifi$ by ! ,secret>y z ( ,decemb] #a1 #bjbd4 7,,viii7 ,9 ! case ( a cov]$ entity describ$ 9 "o ( subp>agraphs 7,l7 ?r\gh 7,o7 ( p>agraph 7#d7 t is a private nonpr(it hospital t has1 z ! basis = its p>ticipation 9 ! program "u ?is section1 a contract ) a ,/ate or local gov]nm5t to provide heal? c>e s]vices to l[-income individuals :o are un9sur$1 z describ$ 9 p>agraphs 7#d77,l77i7 & 7#aa71 ! facility indep5d5tly complies ) all requirem5ts applicable to su* cov]$ entity ) respect to su* contract4 7,,ix7 ,= ! mo/ rec5t ye>1 ! facility's total co/ incurr$ = *>ity c>e 7z su* t]m is def9$ 9 l9e #bc ( work%eet ,s-#aj to ! ,m$ic>e co/ report1 or 9 any successor =m7 furni%$ at su* facility dur+ su* ye>1 z a %>e ( ! facility's total pati5t s]vice rev5ue1 is great] ?an or equal to ! am\nt describ$ 9 item 7aa7 or item 7bb71 :i*ev] is great]-- 7aa7 = su* ye>1 ! total co/ incurr$ = *>ity c>e1 z a %>e ( total pati5t s]vice rev5ue1 furni%$ at ! cov]$ entity's on-campus locations 7z campus is def9$ 9 section #dac4fe7;a77#b7 ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulations772 or 7bb7 ! av]age co/ incurr$ = *>ity c>e1 z a %>e ( total pati5t s]vice rev5ue1 calculat$ = ! ye> prior to ! mo/ rec5t ye> = :i* data is available1 across all hospitals 9 ! ,/ate :]e ! facility is locat$ t receive paym5ts = inpati5t hospital s]vices "u ! prospective paym5t sy/em e/abli%$ "u section #ahhf7;d7 ( ! ,social ,security ,act4 7,x7 ,= ! mo/ rec5t ye>1 ! facility's %>e ( total outpati5t s]vices rev5ue d]iv$ f base reimbursem5t to su* entity 7exclud+ supplem5tal & indirect reimbursem5t7 "u title ,,xix ( ! ,social ,security ,act 7includ+ ) respect to individuals also entitl$ to b5efits "u "p ,a ( title ,,xviii ( su* ,act or enroll$ 9 "p ,b ( title ,,xviii ( su* ,act7 & paym5ts "u title ,,xxi ( su* ,act = items & s]vices furni%$ on an outpati5t basis at ! facility 7includ+ any co/ %>+ = su* items & s]vices7 is great] ?an or equal to ! am\nt describ$ 9 item 7aa7 or item 7bb71 :i*ev] is great]-- 7aa7 = su* ye>1 ! %>e ( total outpati5t s]vices rev5ue d]iv$ f base reimbursem5t to su* entity 7exclud+ supplem5tal & indirect reimbursem5t7 "u title ,,xix ( ! ,social ,security ,act 7includ+ ) respect to individuals also entitl$ to b5efits "u "p ,a ( title ,,xviii ( su* ,act or enroll$ 9 "p ,b ( title ,,xviii ( su* ,act7 & paym5ts "u title ,,xxi ( su* ,act = items & s]vices furni%$ on an outpati5t basis at ! on-campus locations ( ! cov]$ entity ) :i* ! facility is associat$ 7includ+ any co/ %>+ = su* items & s]vices7 7campus %all h ! mean+ giv5 su* t]m 9 section #dac4fe7;a77#b7 ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulations772 or 7bb7 ! av]age %>e ( total outpati5t s]vices rev5ue d]iv$ f base reimbursem5t 7exclud+ supplem5tal & indirect reimbursem5t7 "u title ,,xix ( ! ,social ,security ,act 7includ+ ) respect to individuals also entitl$ to b5efits "u "p ,a ( title ,,xviii ( su* ,act or enroll$ 9 "p ,b ( title ,,xviii ( su* ,act7 & paym5ts "u title ,,xxi ( su* ,act = items & s]vices furni%$ on an outpati5t basis 7includ+ any co/ %>+ = su* items & s]vices71 calculat$ = ! ye> prior to ! mo/ rec5t ye> = :i* data is available1 across all hospitals 9 ! /ate :]e ! facility is locat$ t receive paym5ts = outpati5t hospital s]vices "u ! prospective paym5t sy/em = cov]$ outpati5t dep>tm5t s]vices e/abli%$ "u section #ahcc7t7 ( su* ,act4 7,,xi7 ,! cov]$ entity c]tifies1 at ! "t su* facility is initially regi/]$ = inclusion 9 ! id5tification sy/em describ$ 9 subsection 7d77#b77;,b77iv7 to p>ticipate 9 ! drug pric+ program "u ?is section & annually !reaft] z "p ( ! rec]tification process1 t ! facility satisfies all applicable requirem5ts "u ?is subp>agraph4 7ii7 ,limitation ,only an (f-campus outpati5t facility t meets ea* ( ! requirem5ts "u ?is subp>agraph may pur*ase cov]$ outpati5t drugs "u ! #cdj;,b program or use cov]$ outpati5t drugs pur*as$ "u ! #cdj;,b program by ano!r "p ( ! cov]$ entity t is au?oriz$ to p>ticipate 9 su* program4 ,any transf] ( #cdj;,b drugs to ano!r facility or ano!r "p ( a cov]$ entity t is n au?oriz$ to p>ticipate 9 ! #cdj;,b program %all be deem$ a violation ( subp>agraph 7,b74 7iii7 ,d]egi/ration ,if at any "t foll[+ regi/ration a requirem5t describ$ 9 clause 7i7 is no long] fully satisfi$ ) respect to a facility1 ! cov]$ entity describ$ 9 su* clause %all imm$iately notify ! ,secret>y t su* facility no long] fully satisfies ! relevant requirem5t1 d]egi/] ! facility f ! program "u ?is section1 remove ! facility f ! id5tification sy/em describ$ 9 subsection 7d77#b77;,b77iv71 & take all necess>y actions to prohibit su* facility f mak+ any pur*ases "u ! program "u ?is section or repres5t+ to ?ird p>ties t su* facility may pur*ase cov]$ outpati5t drugs "u su* program4 7iv7 ,obligation to self-disclose ,a cov]$ entity describ$ 9 clause 7i7 %all imm$iately disclose to ! ,secret>y & ! manufactur] ( ! affect$ cov]$ outpati5t drug any pur*ase made "u ! program "u ?is section by or on behalf ( ! cov]$ entity ) respect to a facility t1 at ! "t ( ! pur*ase ( su* drug1 did n fully satisfy ! requirem5ts 9 su* clause4 ,any su* pur*ase %all require ! cov]$ entity to promptly conduct an audit sup]vis$ by ! ,secret>y to id5tify ! full scope ( noncompliance ) su* requirem5ts & to provide ! writt5 results ( su* audit to ! ,secret>y & ! manufactur] ( ! affect$ cov]$ outpati5t drug4 ,! cov]$ entity %all be liable to ! manufactur] ( ! cov]$ outpati5t drug t is ! subject ( ! noncompliance 9 an am\nt equal to ! r$uction 9 ! price ( ! drugs provid$ "u p>agraph 7#a71 plus int]e/ on su* am\nt1 :i* %all be comp\nd$ mon?ly & equal to ! curr5t %ort-t]m int]e/ rate z det]m9$ by ! ,f$]al ,res]ve = ! "t p]iod = :i* ! cov]$ entity is liable4 7v7 ,civil monet>y p5alty ,:]e a cov]$ entity kn[+ly & int5tionally violates clause 7ii7 or o!rwise fails to satisfy a requirem5t 9 clause 7iii7 or clause 7iv71 ! cov]$ entity %all be requir$ to pay a civil monet>y p5alty equal to #b1ejj = ea* su* violation1 :i* am\nt %all be adju/$ = inflation annually to reflect ! rate ( *ange 9 ! ,consum] ,price ,index = ,all ,urban ,consum]s publi%$ by ! ,bureau ( ,labor ,/ati/ics4 ,! provisions ( section #aabh;,a ( ! ,social ,security ,act 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$+ "u section #aabh;,a7a74 ,! ,(fice ( ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all c>ry out ! provisions relat$ to ! imposition ( civil monet>y p5alties "u ?is clause4 7vi7 ,secret>ial publication ( reports ,on an annual basis1 ! ,secret>y %all prep>e & make available to ! public 9 an electronic1 ma*9e readable =mat sep>ate reports li/+ facilities t satisfy ! requirem5ts 9 ea* ( subclauses 7,,ix7 & 7,x7 ( clause 7i74 4 7b7 ,effective date ,! provisions 9 section #cdj;,b7a77#e77;,e7 ( ! ,public ,heal? ,s]vice ,act1 z add$ by ?is ,act1 %all become effective #abj days aft] ! date ( enactm5t ( ?is ,act4 7c7 ,implem5tation ( hospital *ild site /&>ds ,n lat] ?an #fj days prior to ! effective date ( section #cdj;,b7a77#e77;,e7 ( ! ,public ,heal? ,s]vice ,act1 z add$ by ?is ,act1 ! ,secret>y %all issue program in/ructions direct+ ea* cov]$ entity describ$ 9 section #cdj;,b7a77#e77;,e77i7 ( ! ,public ,heal? ,s]vice ,act1 z am5d$ by ?is ,act1 to1 be=e ! effective date ( section #cdj;,b7a77#e77;,e7 ( ! ,public ,heal? ,s]vice ,act1 z add$ by ?is ,act1 regi/] 9 ! id5tification sy/em describ$ 9 section #cdj;,b7d77#b77;,b77iv7 ( ! ,public ,heal? ,s]vice ,act1 or update exi/+ regi/rations 9 su* sy/em =1 (f-campus outpati5t facilities associat$ ) su* cov]$ entity t satisfy ! requirem5ts 9 su* section4 ,su* in/ructions %all direct ea* su* cov]$ entity to1 on or be=e ! effective date ( section #cdj;,b7a77#e77;,e7 ( ! ,public ,heal? ,s]vice ,act1 z add$ by ?is ,act1 remove f su* sy/em ! exi/+ regi/ration ( any (f-campus outpati5t facility associat$ ) su* cov]$ entity t does n satisfy ! requirem5ts 9 section #cdj;,b7a77#e77;,e77i7 ( ! ,public ,heal? ,s]vice ,act4 ,clauses 7iii7 ?r\gh 7v7 ( section #cdj;,b7a77#e77;,e7 ( ! ,public ,heal? ,s]vice ,act %all apply ) respect to any cov]$ entity describ$ 9 "o ( subp>agraphs 7,l7 ?r\gh 7,o7 ( section #cdj;,b7a77#d7 ( ! ,public ,heal? ,s]vice ,act t fails to remove a facility describ$ 9 ! imm$iately prec$+ s5t5ce on or be=e ! effective date ( section #cdj;,b7a77#e77;,e7 ( ! ,public ,heal? ,s]vice ,act1 z add$ by ?is ,act4 #e4 ,contract ph>macies ,section #cdj;,b7a77#e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77#e77 is fur!r am5d$ by add+ at ! end ! foll[+3 7,f7 ,contract ph>macies 7i7 ,9 g5]al ,subject to ! conditions set =? 9 ?is subp>agraph1 a cov]$ entity may ent] into writt5 agreem5ts ) contract ph>macies to disp5se to pati5ts ( su* entity cov]$ outpati5t drugs pur*as$ by su* entity "u ! #cdj;,b program4 ,subject to su* conditions1 a manufactur] ( cov]$ outpati5t drugs %all %ip or facilitate %ipm5t ( su* drugs to contract ph>macies at ! reque/ ( su* cov]$ entity4 ,except ) respect to cov]$ outpati5t drugs %ipp$ to & disp5s$ by a contract ph>macy z provid$ 9 ?is subp>agraph1 & not)/&+ any o!r provision 9 ?is section1 a manufactur] ( cov]$ outpati5t drugs %all h no obligation to pay a disc\nt or rebate "u ?is section ) respect to cov]$ outpati5t drugs deliv]$ or o!rwise transf]r$ to any location o!r ?an a regi/]$ address ( ! cov]$ entity 7includ+ an entity ph>macy or *ild site1 z applicable7 li/$ 9 ! id5tification sy/em describ$ 9 subsection 7d77#b77;,b77iv74 7ii7 ,conditions = cov]$ entity use ( contract ph>macies ,9 ord] = a cov]$ entity to ent] into a writt5 agreem5t ) a contract ph>macy to disp5se to pati5ts ( su* entity cov]$ outpati5t drugs pur*as$ by su* entity "u ! program "u ?is section1 ! entity %all-- 7,i7 7aa7 be describ$ 9 "o ( subp>agraphs 7,a7 ?r\gh 7,k7 ( p>agraph 7#d7 & pur*ase cov]$ outpati5t drugs = its pati5ts )9 ! scope ( ! ,f$]al grant1 project1 or ,f$]al grant-au?oriz+ /atute1 z applicable1 t qualifies su* entity = p>ticipation 9 ! program "u ?is section2 or 7bb7 be describ$ 9 "o ( subp>agraphs 7,l7 ?r\gh 7,o7 ( p>agraph 7#d72 7,,ii7 e/abli% & implem5t compliance proc$ures to satisfy ! requirem5ts describ$ 9 subp>agraphs 7,a71 7,b71 7,g7 7z applicable71 7,h7 7z applicable71 7,j71 & 7,k7 ( p>agraph 7#e7 & section #aaic7;d7 ( ! ,social ,security ,act ) respect to cov]$ outpati5t drugs pur*as$ by ! cov]$ entity "u ?is section1 includ+ ) respect to su* drugs disp5s$ by a contract ph>macy1 :i* compliance proc$ures %all be consid]$ records ( ! cov]$ entity subject to audit "u subp>agraph 7,c72 7,,iii7 prior to pur*as+ cov]$ outpati5t drugs subject to an agreem5t "u ?is section to be %ipp$ to or disp5s$ by su* ph>macy1 regi/] su* ph>macy 9 ! id5tification sy/em describ$ 9 subsection 7d77#b77;,b77iv7 z a contract ph>macy1 to include su* ph>macy's national provid] id5tifi]1 & c]tify to ! ,secret>y ^u initial regi/ration ( su* ph>macy 9 su* sy/em & annually !reaft] t su* ph>macy complies ) all requirem5ts "u ?is subp>agraph1 includ+ ! cov]$ entity compliance proc$ures describ$ 9 subclause 7,,ii72 & 7,,iv7 z applicable1 comply ) ! requirem5ts & limitations set =? 9 clauses 7iii7 ?r\gh 7vii7 ( ?is subp>agraph4 7iii7 ,limitation on contract ph>macies = c]ta9 hospital cov]$ entities ,not)/&+ clause 7ii71 a cov]$ entity describ$ 9 p>agraph 7#d77,l71 a free-/&+ canc] hospital describ$ 9 p>agraph 7#d77,m71 & a rural ref]ral c5t] describ$ 9 p>agraph 7#d77,o7 may n ent] into writt5 agreem5ts ) m ?an #e contract ph>macies to disp5se cov]$ outpati5t drugs pur*as$ by ! cov]$ entity "u ?is section to pati5ts ( su* entity "u ?is subp>agraph4 ,= purposes ( ?is clause1 a contract ph>macy %all n include a mail ord] ph>macy4 7iv7 ,s]vice area requirem5t = eligible contract ph>macies ,a contract ph>macy ) :i* a cov]$ entity ent]s into a writt5 agreem5t to disp5se cov]$ outpati5t drugs to pati5ts ( su* entity subject to ! conditions 9 ?is subp>agraph %all be locat$ 9 ! s]vice area ( ! cov]$ entity 7z def9$ 9 clause 7x77,,iv774 ,not)/&+ any o!r provision 9 ?is subp>agraph1 ?is clause 7iv7 %all n apply ) respect to a cov]$ entity describ$ 9 p>agraph 7#d77;,g7 or a contract ph>macy t is a mail ord] ph>macy4 7v7 ,requirem5ts = use ( mail ord] ph>macies 7,i7 ,9 g5]al ,not)/&+ any o!r provision 9 ?is section1 a cov]$ outpati5t drug subject to an agreem5t "u ?is section may be disp5s$ to a pati5t ( a cov]$ entity ?r\gh a mail ord] ph>macy only if-- 7aa7 ! cov]$ entity disp5s+ su* drug 7or on ^: behalf su* drug is disp5s$7 ?r\gh a mail ord] ph>macy to su* a pati5t is describ$ 9 "o ( subp>agraphs 7,a7 ?r\gh 7,k7 ( p>agraph 7#d71 su* entity is n a specifi$ nonhospital cov]$ entity 7z def9$ 9 subsection 7b77#d771 &1 except = a cov]$ entity describ$ 9 subp>agraph 7,g7 ( su* subsection1 ! pati5t disp5s$ su* drug resides )9 ! s]vice area ( ! cov]$ entity 7z def9$ 9 clause 7x77,,iv772 or 7bb7 ! cov]$ entity disp5s+ su* drug 7or on ^: behalf su* drug is disp5s$7 ?r\gh a mail ord] ph>macy to su* a pati5t is describ$ 9 subp>agraph 7,n7 ( p>agraph 7#d7 or is a sole community hospital describ$ 9 subp>agraph 7,o7 ( su* p>agraph1 & ! pati5t disp5s$ su* drug resides 9 a c\nty t is n "p ( a ,metropolitan ,/ati/ical ,area1 z def9$ by ! ,(fice ( ,managem5t & ,budget4 7,,ii7 ,requirem5ts = use ( mail ord] contract ph>macies ,subject to ! conditions set =? 9 ?is subp>agraph1 a cov]$ entity describ$ 9 item 7aa7 or 7bb7 ( subclause 7,i7 may ent] into writt5 agreem5ts ) contract ph>macies t are mail ord] ph>macies to disp5se to pati5ts describ$ 9 su* relevant clause cov]$ outpati5t drugs pur*as$ by su* entity "u ! #cdj;,b program4 7vi7 ,requirem5ts = cov]$ entity compliance proc$ures & writt5 agreem5ts ,n lat] ?an #ahj days foll[+ ! date ( enactm5t ( ! #cdj;,b ,,access ,act1 ! ,secret>y %all issue guidance to cov]$ entities specify+ requirem5ts =-- 7,i7 cov]$ entity compliance proc$ures describ$ 9 clause 7ii77,,ii7 t ! ,secret>y det]m9es are suffici5t to ensure t cov]$ outpati5t drugs are n subject to duplicate disc\nts 9 violation ( subsection 7a77#e77;,a7 7includ+ ) respect to su* drugs us$ by ,m$icaid manag$ c>e enrollees71 t su* drugs _c be resold or o!rwise transf]r$ to p]sons :o d n meet ! def9ition ( a pati5t ( ! cov]$ entity 9 violation ( subp>agraph 7,b71 t ! pati5t af=dability requirem5ts specifi$ 9 subp>agraphs 7,g7 & 7,h71 z applicable1 are appropriately appli$ at ! po9t ( drug disp5se or adm9i/ration1 t data & o!r in=mation is submitt$ 9 accordance ) subp>agraphs 7,j7 & 7,k71 & t ! nonduplication requirem5t 9 section #aaic7;d7 ( ! ,social ,security ,act is satisfi$2 & 7,,ii7 writt5 agreem5ts betwe5 cov]$ entities & contract ph>macies describ$ 9 clause 7vii74 7vii7 ,writt5 agreem5t requir$ ,! writt5 agreem5t betwe5 a cov]$ entity & a contract ph>macy describ$ 9 ?is subp>agraph %all include b9d+ & en=ceable obligations on ! contract ph>macy to comply ) ! cov]$ entity's compliance proc$ures describ$ 9 clause 7ii77,,ii7 ) respect to cov]$ outpati5t drugs disp5s$ to pati5ts ( su* entity 9 accordance ) ?is subp>agraph4 ,)9 #cj days ( ! applicable effective date ( su* writt5 agreem5t1 includ+ any am5dm5t or add5dum !reto1 ! cov]$ entity %all submit a copy ( ! agreem5t1 toge!r ) any am5dm5ts or add5da1 to ! ,secret>y 9 a =m & mann] specifi$ by ! ,secret>y4 ,! ,secret>y %all review all su* agreem5ts1 includ+ am5dm5ts & add5da1 = compliance ) ! requirem5ts set =? 9 ?is subp>agraph & may require a cov]$ entity & contract ph>macy to modify an agreem5t to con=m to ! requirem5ts ( ?is subp>agraph4 ,su* agreem5ts1 includ+ am5dm5ts & add5da1 %all be consid]$ records ( ! cov]$ entity subject to audit "u subp>agraph 7,c74 7viii7 ,cl>ification = cov]$ outpati5t drugs subject to re/rict$ di/ribution ,not)/&+ any o!r provision 9 ?is section1 a manufactur] ( a cov]$ outpati5t drug requir+ exclusive use ( a specialty ph>macy or a re/rict$ di/ribution network %all be deem$ to h satisfi$ its obligations "u ?is subp>agraph ) respect to a contract ph>macy if su* manufactur] (f]s ea* cov]$ entity su* drug = pur*ase at or bel[ ! applicable ceil+ price describ$ 9 p>agraph 7#a7 ?r\gh a :olesal]1 di/ributor1 or ph>macy includ$ 9 ! re/rict$ di/ribution network = su* drug4 7ix7 ,p5alties = contract ph>macy compliance violations 7,i7 ,9 g5]al ,a contract ph>macy t is f\nd to h violat$ ! cov]$ entity compliance proc$ures describ$ 9 clause 7ii77,,ii71 violat$ subp>agraph 7,a71 or violat$ subp>agraph 7,b7 %all-- 7aa7 9 ! fir/ in/ance ( su* violation1 be liable to a manufactur] ( a cov]$ outpati5t drug t is ! subject ( su* violation 9 an am\nt equal to ! r$uction 9 ! price ( su* drug 7z describ$ 9 subsection 7a77#a771 plus int]e/ on su* am\nt1 :i* %all be comp\nd$ mon?ly & equal to ! curr5t %ort-t]m int]e/ rate z det]m9$ by ! ,f$]al ,res]ve = ! "t p]iod = :i* ! cov]$ entity is liable2 7bb7 9 ! second in/ance ( su* violation-- 7,,aa7 be liable to a manufactur] ( a cov]$ outpati5t drug t is ! subject ( su* violation 9 an am\nt equal to ! r$uction 9 ! price ( ! drug 7z describ$ 9 p>agraph 7#a771 plus int]e/ on su* am\nt1 :i* %all be calculat$ 9 ! mann] specifi$ 9 item 7aa72 & 7,,bb7 be requir$ to pay a civil monet>y p5alty equal to #c1jjj = ea* claim = a cov]$ outpati5t drug t is subject to ! violation1 :i* am\nt %all be adju/$ = inflation annually to reflect ! rate ( *ange 9 ! ,consum] ,price ,index = ,all ,urban ,consum]s publi%$ by ! ,bureau ( ,labor ,/ati/ics2 & 7cc7 9 ! ?ird in/ance ( su* violation-- 7,,aa7 be liable to a manufactur] ( a cov]$ outpati5t drug t is ! subject ( su* violation 9 an am\nt equal to ! r$uction 9 ! price ( ! drug 7z describ$ 9 p>agraph 7#a771 plus int]e/ on su* am\nt1 :i* %all be calculat$ 9 ! mann] specifi$ 9 item 7aa72 7,,bb7 be requir$ to pay a civil monet>y p5alty equal to #c1jjj = ea* claim = a cov]$ outpati5t drug t is subject to ! violation1 :i* am\nt %all be adju/$ = inflation annually to reflect ! rate ( *ange 9 ! ,consum] ,price ,index = ,all ,urban ,consum]s publi%$ by ! ,bureau ( ,labor ,/ati/ics2 & 7,,cc7 be remov$ f ! program "u ?is section & disqualifi$ f re5try into su* program = a p]iod ( n less ?an two ye>s1 or su* long] p]iod z ! ,secret>y may det]m9e bas$ on ! sev]ity ( ! violation 7or violations7 & ! risk su* ph>macy pres5ts to ! integrity ( ! program1 ) no ability to re5t] ! program unless & until ! ,secret>y det]m9es su* ph>macy has resolv$ ! violation 7or violations7 & tak5 reasonable /eps to prev5t simil> future violations4 7,,ii7 ,corrective action plan ,9 ! fir/ in/ance ( a violation describ$ 9 subclause 7,i77aa71 9 ! second in/ance ( a violation describ$ 9 subclause 7,i77bb71 & prior to re5try into ! program foll[+ a violation describ$ 9 subclause 7,i77cc7-- 7aa7 ! ph>macy %all conduct an int]nal review to id5tify ! cause ( ! violation 7or violations7 t is inclusive ( all cal5d> qu>t]s )9 ! p]iod 9 :i* su* violation 7or violations7 occurr$ & all cov]$ outpati5t drugs subject to an agreem5t "u ?is section disp5s$ dur+ su* p]iod2 7bb7 ! ph>macy %all prep>e a writt5 corrective action plan1 9 a =m specifi$ by ! ,secret>y1 :i* %all include1 at a m9imum1 ! results ( su* int]nal review1 ! ph>macy's me?odology = id5tify+ ! full scope ( su* violation 7or violations71 & ! ph>macy's propos$ corrective actions1 & submit su* plan to ! ,secret>y 9 a =m & mann] specifi$ by ! ,secret>y2 & 7cc7 ! ,secret>y %all review su* plan1 notify ! ph>macy ( any revisions to su* plan1 includ+ additional corrective actions1 necess>y = ! ,secret>y to approve su* plan1 & publi% ! approv$ plan on a public website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices 7) r$actions ( any confid5tial or propriet>y in=mation74 7,,iii7 ,civil monet>y p5alty = violations by remov$ ph>macy ,a contract ph>macy remov$ f ! program "u ?is section pursuant to subclause 7,i77cc7 t disp5ses a cov]$ outpati5t drug subject to an agreem5t "u ?is section dur+ a "t p]iod t su* ph>macy is remov$ f ! program & is n approv$ = re5try %all be requir$ to pay a civil monet>y p5alty equal to #c1jjj = ea* claim = ea* su* drug disp5s$ dur+ su* p]iod1 :i* am\nt %all be adju/$ = inflation annually to reflect ! rate ( *ange 9 ! ,consum] ,price ,index = ,all ,urban ,consum]s publi%$ by ! ,bureau ( ,labor ,/ati/ics4 7,,iv7 ,proc$ures & delegation ,! provisions ( section #aabh;,a ( ! ,social ,security ,act 7o!r ?an subsections 7a7 & 7b77 %all apply = purposes ( any paym5t1 civil monet>y p5alty1 or removal describ$ 9 ?is clause 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 ,! ,(fice ( ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all c>ry out ! provisions ( ?is clause4 7x7 ,def9itions ,9 ?is subp>agraph3 7,i7 ,contract ph>macy ,! t]m contract ph>macy means1 ) respect to a cov]$ entity describ$ 9 clause 7ii71 any individual ph>macy 7z det]m9$ by a national provid] id5tifi] unique to ! ph>macy address7 t is-- 7aa7 lic5s$ z a ph>macy by ! relevant ,/ate 7or ,/ates72 7bb7 au?oriz$ to disp5se cov]$ outpati5t drugs subject to an agreem5t "u ?is section to pati5ts ( su* entity 7z def9$ 9 subsection 7b77#c77 pursuant to a valid writt5 agreem5t ) su* entity 7z describ$ 9 ?is subp>agraph72 & 7cc7 n an entity ph>macy4 7,,ii7 ,entity ph>macy ,! t]m entity ph>macy means any individual ph>macy 7z det]m9$ by a national provid] id5tifi] unique to ! ph>macy address7 t is-- 7aa7 7,,aa7 lic5s$ z a ph>macy by ! relevant ,/ate 7or ,/ates72 & 7,,bb7 ! same legal entity z ! cov]$ entity & locat$ )9 ! cov]$ entity's s]vice area1 if ! cov]$ entity is describ$ 9 "o ( subp>agraphs 7,a7 ?r\gh 7,k7 ( p>agraph 7#d7 & is n a specifi$ nonhospital cov]$ entity 7z def9$ 9 subsection 7b77#d772 or 7bb7 ! same legal entity z ! cov]$ entity & locat$ )9 ! cov]$ entity's f\r walls1 if ! cov]$ entity is describ$ 9 "o ( subp>agraphs 7,l7 ?r\gh 7,o7 ( p>agraph 7#d7 or is a specifi$ nonhospital cov]$ entity 7z def9$ 9 subsection 7b77#d774 7,,iii7 ,mail ord] ph>macy ,! t]m mail ord] ph>macy is a ph>macy t is lic5s$ z a ph>macy by ! ,/ate 7or ,/ates7 & t disp5ses prescription m$ications to individuals prim>ily ?r\gh ! mail1 z det]m9$ 9 accordance ) guidance issu$ by ! ,secret>y 9 connection ) "p #ddg1 subp>t ,i ( title #db ( ! ,code ( ,f$]al ,regulations 7or any successor regulations74 7,,iv7 ,s]vice area ,! t]m s]vice area means1 ) respect to a cov]$ entity describ$ 9 p>agraph 7#d71 o!r ?an a cov]$ entity describ$ 9 subp>agraph 7,g7 ( su* p>agraph1 ! ,public ,use ,microdata ,area 7z def9$ by ! ,unit$ ,/ates ,c5sus ,bureau7 9 :i* su* entity is locat$ & all ,public ,use ,microdata ,areas t are contigu\s ) ! ,public ,use ,microdata ,area 9 :i* su* entity is locat$1 ea* ( :i* %all be li/$ 9 ! id5tification sy/em describ$ 9 subsection 7d77#b77;,b77iv74 7xi7 ,rules ( con/ruction 7,i7 ,location ,= purposes ( ?is subp>agraph1 ! location ( a cov]$ entity %all be det]m9$ bas$ on ! physical address ( ! entity li/$ 9 ! id5tification sy/em describ$ 9 subsection 7d77#b77;,b77iv7 )\t reg>d to any (f-campus outpati5t facilities4 7,,ii7 ,same legal entity ,= purposes ( ?is subp>agraph1 a ph>macy is ! same legal entity z ! cov]$ entity if ! "n1 own]%ip1 & employ] id5tification numb] ( ! ph>macy is id5tical to ! "n1 own]%ip1 & employ] id5tification numb] ( ! cov]$ entity4 4 #f4 ,ensur+ pati5t af=dability ( drugs pur*as$ "u section #cdj;,b 7a7 ,9 g5]al ,section #cdj;,b7a77#e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77#e77 is fur!r am5d$ by add+ at ! end ! foll[+3 7,g7 ,pati5t af=dability requirem5ts = hospital cov]$ entities 7i7 ,9 g5]al ,not)/&+ any o!r provision ( law1 a cov]$ entity describ$ 9 "o ( subp>agraphs 7,l7 ?r\gh 7,o7 ( p>agraph 7#d7 %all e/abli% a slid+ fee scale t results 9 ! cov]$ entity provid+1 on behalf ( an eligible pati5t 7z def9$ 9 clause 7iv771 a disc\nt t results 9 su* pati5t pay+ no m ?an ! maximum out-(-pocket obligation 7z def9$ 9 clause 7ii771 ) respect to ea* cov]$ outpati5t drug subject to an agreem5t "u ?is section disp5s$1 furni%$1 or adm9i/]$ to su* pati5t at su* cov]$ entity1 any *ild site1 or any entity ph>macy4 ,! slid+ fee scale & relat$ policies %all be writt5 & po/$ prom95tly at ea* su* cov]$ entity location1 includ+ any *ild site & entity ph>macy1 & %all be includ$ 9 any bill+-relat$ communications s5t by su* cov]$ entity to any pati5t disp5s$1 furni%$1 or adm9i/]$ a cov]$ outpati5t drug at su* cov]$ entity location1 includ+ any *ild site or entity ph>macy4 ,eligibility = a r$uc$ out-(-pocket obligation pursuant to ?is clause %all be bas$ on insurance & income in=mation provid$ by ! eligible pati5t4 ,) respect to cov]$ outpati5t drugs t are self-adm9i/]$ by an eligible pati5t1 ! out-(-pocket r$uctions describ$ 9 ?is clause %all apply at ! po9t ( sale4 7ii7 ,maximum out-(-pocket obligation ,= ea* disp5se or adm9i/ration ( a cov]$ outpati5t drug1 ! maximum out-(-pocket obligation = an eligible pati5t ) family income-- 7,i7 bel[ ! ,f$]al pov]ty guidel9es is #j2 7,,ii7 at or above ! ,f$]al pov]ty guidel9es b bel[ #bjj p]c5t ( ! ,f$]al pov]ty guidel9es is ! less] ( #bj p]c5t ( ! o!rwise applicable out-(-pocket obligation or #ce1 :i* %all be adju/$ = inflation annually to reflect rate ( ! *ange 9 ! ,consum] ,price ,index = ,all ,urban ,consum]s publi%$ by ! ,bureau ( ,labor ,/ati/ics2 & 7,,iii7 at or above #bjj p]c5t ( ! ,f$]al pov]ty guidel9es is ! less] ( #cj p]c5t ( ! o!rwise applicable out-(-pocket obligation or #ej1 :i* %all be adju/$ = inflation annually to reflect rate ( ! *ange 9 ! ,consum] ,price ,index = ,all ,urban ,consum]s publi%$ by ! ,bureau ( ,labor ,/ati/ics4 7iii7 ,applicability to contract ph>macies ,) respect to an eligible pati5t ( a cov]$ entity describ$ 9 clause 7i7 disp5s$ a cov]$ outpati5t drug subject to an agreem5t "u ?is section on behalf ( su* cov]$ entity at a contract ph>macy pursuant to subp>agraph 7,f71 su* cov]$ entity %all require su* contract ph>macy to provide disc\nts to eligible pati5ts on behalf ( su* cov]$ entity & comply ) all o!r requirem5ts describ$ 9 clauses 7i7 & 7ii7 z if su* contract ph>macy 7 a cov]$ entity describ$ 9 clause 7i74 7iv7 ,def9itions ,9 ?is subp>agraph3 7,i7 ,*ild site ,! t]m *ild site %all h ! mean+ giv5 su* t]m 9 subp>agraph 7,e74 7,,ii7 ,contract ph>macy ,! t]m contract ph>macy %all h ! mean+ giv5 su* t]m 9 subp>agraph 7,f74 7,,iii7 ,eligible pati5t ,! t]m eligible pati5t means a pati5t1 z def9$ 9 subsection 7b77#c71 :o is n cov]$ "u m9imum ess5tial cov]age z def9$ "u section #ejjj;,a7f7 ( ! ,int]nal ,rev5ue ,code ( #aihf or has family income bel[ #bjj p]c5t ( ! ,f$]al pov]ty guidel9es & is cov]$ "u a gr\p heal? plan1 heal? insurance cov]age 9 ! individual m>ket or gr\p m>ket 7z su* t]ms are def9$ 9 section #bgia ( ! ,public ,heal? ,s]vice ,act7 or cov]age describ$ 9 section #aef4fjb7;a71 title #de1 ,code ( ,f$]al ,regulations or successor regulation4 7,,iv7 ,entity ph>macy ,! t]m entity ph>macy %all h ! mean+ giv5 su* t]m 9 subp>agraph 7,f74 7,v7 ,f$]al pov]ty guidel9es ,! t]m ,f$]al pov]ty guidel9es means ! pov]ty guidel9es updat$ p]iodically 9 ! ,f$]al ,regi/] by ! ,dep>tm5t ( ,heal? & ,human ,s]vices pursuant to section #iijb7b7 ( title #db1 ,unit$ ,/ates ,code4 7,,vi7 ,out-(-pocket obligation ,! t]m out-(-pocket obligation means any copaym5t1 co9surance1 d$uctible1 or o!r co/ %>+ am\nt or paym5t requir$ f an eligible pati5t 9 connection ) su* pati5t's receipt ( a specific heal? c>e item or s]vice1 includ+ a cov]$ outpati5t drug4 7v7 ,civil monet>y p5alty ,a cov]$ entity or contract ph>macy t violates a requirem5t ( ?is subp>agraph %all be subject to a civil monet>y p5alty ( #b1ejj = ea* su* violation1 :i* am\nt %all be adju/$ = inflation annually to reflect ! rate ( *ange 9 ! ,consum] ,price ,index = ,all ,urban ,consum]s publi%$ by ! ,bureau ( ,labor ,/ati/ics4 ,! provisions ( section #aabh;,a ( ! ,social ,security ,act 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$+ "u section #aabh;,a7a74 ,! ,(fice ( ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all c>ry out ! provisions ( ?is clause4 7vi7 ,regulations ,! ,secret>y %all promulgate regulations ?r\gh notice & comm5t rulemak+ to implem5t ! requirem5ts describ$ 9 ?is subp>agraph & %all issue f9al regulations n lat] ?an #ij days aft] ! date ( enactm5t ( ?is subp>agraph4 ,! au?ority to promulgate regulations "u ?is clause is limit$ to specify+ ! obligations ( cov]$ entities & contract ph>macies "u ?is subp>agraph & o!r details necess>y to c>ry out ! requirem5ts ( ?is subp>agraph effici5tly1 effectively1 & 9 con=mity ) ?is subp>agraph4 7vii7 ,,oig /udies ,! ,(fice ( ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all conduct & publi% annual /udies ( cov]$ entity 7includ+ *ild site & entity ph>macy7 & contract ph>macy practices ) respect to ! requirem5ts "u ?is subp>agraph & evaluate :e!r eligible pati5ts are receiv+ assi/ance to r$uce _! out-(-pocket obligations 9 accordance ) ?is subp>agraph4 7,h7 ,pati5t af=dability requirem5ts = c]ta9 nonhospital cov]$ entities 7i7 ,9 g5]al ,not)/&+ any o!r provision ( law1 a cov]$ entity describ$ 9 "o ( subp>agraphs 7,a7 ?r\gh 7,k7 ( p>agraph 7#d7 t is requir$ by ! ,f$]al /atute au?oriz+ ! grant1 project1 or contract t is ! basis = su* entity's p>ticipation 9 ! program "u ?is section to provide af=dability assi/ance to eligible individuals receiv+ heal? c>e items or s]vices f su* entity %all1 ) respect to an eligible pati5t 7z def9$ 9 clause 7iii77 disp5s$ or adm9i/]$ a cov]$ outpati5t drug subject to an agreem5t "u ?is section at a cov]$ entity site1 includ+ an entity ph>macy1 e/abli% a policy t provides a disc\nt to r$uce ! out-(-pocket obligation ( an eligible pati5t ) respect to su* drug to an am\nt suffici5t to ensure su* pati5t is n d5i$ access to su* drug bas$ on su* pati5t's ability to pay = su* drug4 7ii7 ,applicability to contract ph>macies ,) respect to an eligible pati5t ( a cov]$ entity describ$ 9 clause 7i7 disp5s$ a cov]$ outpati5t drug subject to an agreem5t "u ?is section on behalf ( su* cov]$ entity at a contract ph>macy pursuant to subp>agraph 7,f71 su* cov]$ entity %all require su* contract ph>macy to provide disc\nts to eligible pati5ts on behalf ( su* cov]$ entity 9 accordance ) ! cov]$ entity's policy describ$ 9 clause 7i74 7iii7 ,def9itions ,9 ?is subp>agraph3 7,i7 ,contract ph>macy ,! t]m contract ph>macy %all h ! mean+ giv5 su* t]m 9 subp>agraph 7,f74 7,,ii7 ,eligible pati5t ,! t]m eligible pati5t means a pati5t1 z def9$ 9 subsection 7b77#c71 :o is n cov]$ "u m9imum ess5tial cov]age z def9$ "u section #ejjj;,a7f7 ( ! ,int]nal ,rev5ue ,code ( #aihf or has family income bel[ #bjj p]c5t ( ! ,f$]al pov]ty guidel9es & is cov]$ "u a gr\p heal? plan1 heal? insurance cov]age 9 ! individual m>ket or gr\p m>ket 7z su* t]ms are def9$ 9 section #bgia ( ! ,public ,heal? ,s]vice ,act7 or cov]age describ$ 9 section #aef4fjb7;a71 title #de1 ,code ( ,f$]al ,regulations or successor regulation4 7,,iii7 ,entity ph>macy ,! t]m entity ph>macy %all h ! mean+ giv5 su* t]m 9 subp>agraph 7,f74 7,,iv7 ,f$]al pov]ty guidel9es ,! t]m ,f$]al pov]ty guidel9es means ! pov]ty guidel9es updat$ p]iodically 9 ! ,f$]al ,regi/] by ! ,dep>tm5t ( ,heal? & ,human ,s]vices pursuant to section #iijb7b7 ( title #db1 ,unit$ ,/ates ,code4 7,v7 ,out-(-pocket obligation ,! t]m out-(-pocket obligation means any copaym5t1 co9surance1 d$uctible1 or o!r co/ %>+ am\nt or paym5t requir$ f an eligible pati5t 9 connection ) su* pati5t's receipt ( a specific heal? c>e item or s]vice1 includ+ a cov]$ outpati5t drug4 4 #g4 ,requirem5ts = nonhospital cov]$ entities & subgrantees ,section #cdj;,b7a77#e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77#e77 is fur!r am5d$ by add+ at ! end ! foll[+3 7,i7 ,additional requirem5ts = nonhospital cov]$ entities2 requirem5ts = subgrantees 7i7 ,additional requirem5ts = nonhospital cov]$ entities ,a cov]$ entity describ$ 9 "o ( subp>agraphs 7,a7 ?r\gh 7,k7 ( p>agraph 7#d7 %all1 z a condition ( p>ticipation 9 ! program "u ?is section-- 7,i7 be a nonpr(it or public entity 7z det]m9$ by ! ,secret>y72 7,,ii7 be eligible to pur*ase a cov]$ outpati5t drug subject to an agreem5t "u ?is section only ) respect to a pati5t receiv+ a heal? c>e s]vice at a regi/]$ cov]$ entity site1 & su* s]vice & su* drug are )9 ! scope & "t p]iod ( ! ,f$]al grant1 project1 or ,f$]al grant-au?oriz+ /atute1 z applicable1 t qualifies su* cov]$ entity = p>ticipation 9 ! program "u ?is section2 7,,iii7 ov]see ! p>ticipation 9 ! program "u ?is section ( any subgrantee ) :i* su* cov]$ entity ent]s into an en=ceable writt5 agreem5t 9 accordance ) subclause 7,,iv7 & be directly liable = noncompliance by any su* subgrantee ) any requirem5t "u ?is section2 7,,iv7 h an en=ceable writt5 agreem5t ) any subgrantee1 :i* %all apply to all regi/]$ sites ( su* subgrantee1 & require su* subgrantee to comply ) all requirem5ts "u ?is section o!rwise applicable to ! cov]$ entity & to ma9ta9 writt5 records1 :i* %all be made available to ! ,secret>y ^u reque/1 suffici5t to demon/rate su* subgrantee's receipt ( eligible ,f$]al funds or an 9-k9d contribution pur*as$ ) su* funds1 z describ$ 9 clause 7iii71 & ! grant "u :i* su* subgrantee receives su* funds or contribution2 & 7,v7 ma9ta9 writt5 records suffici5t to demon/rate su* entity au?oriz$ su* subgrantee to1 prior to pur*as+ cov]$ outpati5t drugs subject to an agreem5t "u ?is section1 regi/] ea* subgrantee site 9 ! cov]$ entity id5tification sy/em e/abli%$ "u subsection 7d77#b77;,b77iv7 to p>ticipate 9 ! program "u ?is section z a subgrantee ( su* entity & provide ! ,secret>y ) su* regi/ration in=mation z reque/$ to demon/rate su* subgrantee's receipt ( eligible ,f$]al funds or an 9-k9d contribution pur*as$ ) su* funds1 z describ$ 9 clause 7iii71 & ! grant "u :i* ! subgrantee receives su* funds or contribution4 7ii7 ,requirem5ts = subgrantees ,not)/&+ any o!r provision 9 ?is section1 a subrecipi5t ( a ,f$]al grant %all be eligible to p>ticipate 9 ! program "u ?is section only if su* subrecipi5t is a subgrantee 7z def9$ 9 clause 7iii77 & su* subgrantee-- 7,i7 is a nonpr(it or public entity 7z det]m9$ by ! ,secret>y72 7,,ii7 prior to pur*as+ cov]$ outpati5t drugs subject to an agreem5t "u ?is section-- 7aa7 ent]s into an en=ceable writt5 agreem5t ) ! cov]$ entity provid+ eligible ,f$]al funds or an 9-k9d contribution1 pursuant to clause 7i77,,iv72 7bb7 ma9ta9s writt5 records1 :i* %all be made available to ! ,secret>y ^u reque/1 suffici5t to demon/rate su* subgrantee's receipt ( eligible ,f$]al funds or an 9-k9d contribution pur*as$ ) su* funds1 z describ$ 9 clause 7iii71 & ! grant "u :i* su* subgrantee receives su* funds or contribution2 & 7cc7 regi/]s ea* subgrantee site to p>ticipate 9 ! program "u ?is section 9 ! cov]$ entity id5tification sy/em e/abli%$ "u subsection 7d77#b77;,b77iv72 7,,iii7 pur*ases cov]$ outpati5t drugs subject to an agreem5t "u ?is section only ) respect to a pati5t receiv+ a heal? c>e s]vice at a regi/]$ subgrantee site1 & su* s]vice & su* drug are )9 ! scope & "t p]iod ( ! ,f$]al grant1 project1 or grant-au?oriz+ /atute1 z applicable1 t qualifies su* subgrantee = p>ticipation 9 ! program "u ?is section2 7,,iv7 9 ! case ( a subgrantee t receives an 9-k9d contribution f a cov]$ entity describ$ 9 p>agraph 7#d77,k71 demon/rates to su* cov]$ entity & to ! ,secret>y1 ^u initial regi/ration to p>ticipate 9 ! program "u ?is section & on an annual basis !reaft]1 t ! numb] ( individuals ag$ #ai to #fd ye>s receiv+ a heal? c>e s]vice at ! regi/]$ subgrantee site dur+ ! mo/ rec5t cal5d> ye> :o are enroll$ "u a ,/ate plan "u title ,,xix ( ! ,social ,security ,act 7or a waiv] ( su* plan71 z a %>e ( all individuals ag$ #ai to #fd ye>s receiv+ a heal? c>e s]vice at ! regi/]$ subgrantee site dur+ su* cal5d> ye>1 exce$s ! numb] ( individuals ag$ #ai to #fd ye>s :o reside 9 ! ,/ate :]e su* subgrantee site is locat$ & are enroll$ "u a ,/ate plan "u title ,,xix ( su* ,act 7or a waiv] ( su* plan71 z a %>e ( all individuals ag$ #ai to #fd :o reside 9 su* ,/ate1 ea* z measur$ by data available f ! ,am]ican ,community ,survey ( ! ,bureau ( ! ,c5sus = ! cal5d> ye> prec$+ ! mo/ rec5t cal5d> ye>2 7,v7 9 ! case ( a subgrantee t receives an 9-k9d contribution f a cov]$ entity describ$ 9 p>agraph 7#d77,k71 submits to su* cov]$ entity & to ! ,secret>y1 ^u receipt ( ea* 9-k9d contribution describ$ 9 clause 7iii7-- 7aa7 a writt5 plan 9 a =m specifi$ by ! ,secret>y describ+ h[ su* contribution w be us$ to fur!r ! goals ( ! relevant ,f$]al grant1 h[ su* subgrantee w ensure t pur*ases ( cov]$ outpati5t drugs "u ! program "u ?is section are consi/5t ) ! goals ( su* grant1 & h[ su* subgrantee w ensure compliance ) ! requirem5ts "u subp>agraph 7,a7 & 7,b72 & 7bb7 a writt5 plan 9 a =m specifi$ by ! ,secret>y & us+ crit]ia e/abli%$ by ! ,secret>y to det]m9e ! date ^u :i* its eligibility to p>ticipate 9 ! program "u ?is section1 z a result ( su* contribution1 %all t]m9ate 7abs5t su* subgrantee's receipt ( additional funds or contributions describ$ 9 clause 7iii772 7,,vi7 subject to subclause 7,,vii71 imm$iately notifies ! ,secret>y1 dis5rolls f ! program "u ?is section1 & discont9ues mak+ pur*ases "u su* program & repres5t+ to ?ird p>ties t x may pur*ase "u su* program z ( ! date describ$ 9 subclause 7,v77bb7 or if1 at any "t dur+ its p>ticipation 9 ! program "u ?is section1 x no long] meets "o or m applicable requirem5ts "u ?is section2 & 7,,vii7 n lat] ?an #cj days foll[+ ! date on :i* ! cov]$ entity ) :i* su* subgrantee has an agreem5t pursuant to clause 7i7 ceases p>ticipation 9 ! program "u ?is section1 su* subgrantee ei!r-- 7aa7 dis5rolls f ! program "u ?is section & discont9ues mak+ pur*ases "u su* program & repres5t+ to ?ird p>ties t su* subgrantee may pur*ase "u su* program2 or 7bb7 ent]s into an en=ceable writt5 agreem5t ) a diff]5t cov]$ entity describ$ 9 "o ( subp>agraphs 7,a7 ?r\gh 7,k7 ( p>agraph 7#d7 t is p>ticipat+ 9 ! program "u ?is section1 & satisfies all applicable requirem5ts "u ?is section ) respect to su* diff]5t cov]$ entity4 7iii7 ,subgrantee def9$ 7,i7 ,9 g5]al ,9 ?is subp>agraph1 ! t]m subgrantee means a subrecipi5t ( a ,f$]al grant t-- 7aa7 receives eligible ,f$]al funds f a cov]$ entity describ$ 9 "o ( subp>agraphs 7,a7 ?r\gh 7,k7 ( p>agraph 7#d7 9 ! =m ( nonnom9al & ongo+ paym5ts by su* cov]$ entity directly to su* subrecipi5t to directly support ! provision ( heal? c>e s]vices by su* subrecipi5t to individuals )9 ! scope & "t p]iod ( ! ,f$]al grant1 project1 or ,f$]al grant-au?oriz+ /atute1 z applicable1 t qualifies su* cov]$ entity = p>ticipation 9 ! program "u ?is section2 or 7bb7 receives 9-k9d contributions f a cov]$ entity describ$ 9 p>agraph 7#d77,k7 & su* contributions-- 7,,aa7 are ongo+ & are 9 ! =m ( real prop]ty1 equipm5t1 supplies1 or s]vices2 7,,bb7 subject to subclause 7,,ii71 h a value exce$+ #be1jjj p] ye>1 :i* %all be adju/$ = inflation annually to reflect ! rate ( *ange 9 ! ,consum] ,price ,index = ,all ,urban ,consum]s publi%$ by ! ,bureau ( ,labor ,/ati/ics & det]m9$ by ! subrecipi5t & approv$ by ! cov]$ entity provid+ su* contribution 9 a mann] specifi$ by ! ,secret>y2 7,,cc7 are specifically id5tifiable & provid$ by su* cov]$ entity directly to su* subrecipi5t2 & 7,,dd7 directly support ! provision ( heal? c>e items & s]vices by su* subrecipi5t solely to individuals )9 ! scope & "t p]iod ( ! ,f$]al grant t qualifies su* cov]$ entity = p>ticipation 9 ! program "u ?is section4 7,,ii7 ,exclusion ,! requirem5t specifi$ 9 subclause 7,i77bb77,,bb7 %all n apply ) respect to a subrecipi5t ( a ,f$]al grant t receives 9-k9d contributions f a cov]$ entity describ$ 9 p>agraph 7#d77,k7 if-- 7aa7 z ( ,janu>y #a1 #bjbe1 su* subrecipi5t is p>ticipat+ 9 ! program "u ?is section z su* a subrecipi5t & is 9 compliance ) all requirem5ts "u ?is section o!rwise applicable to su* subrecipi5t2 & 7bb7 ) respect to any 9-k9d contribution su* subrecipi5t receives aft] ,janu>y #a1 #bjbe1 su* subrecipi5t has cont9u\sly p>ticipat$ 9 ! program "u ?is section z su* a subrecipi5t 9 compliance ) all requirem5ts "u ?is section = ! p]iod beg9n+ on ,janu>y #a1 #bjbe1 & cont9u+ ?r\gh ! date on :i* program p>ticipation ends z det]m9$ 9 ! plan submitt$ to ! ,secret>y pursuant to clause 7ii77,v77bb7 or any su* e>li] date on :i* program p>ticipation ends4 7iv7 ,rule ( con/ruction ,= purposes ( ?is section1 any subgrantee t is n itself a cov]$ entity describ$ 9 "o ( subp>agraphs 7,a7 ?r\gh 7,k7 ( p>agraph 7#d7 %all be subject to ! obligations "u ?is section applicable to ! cov]$ entity ) :i* su* subgrantee has an en=ceable writt5 agreem5t pursuant to clause 7i74 ,fur!r1 = purposes ( ?is section1 ea* regi/]$ site ( su* subgrantee %all be subject to ! requirem5ts set =? 9 subp>agraph 7,f7 z if su* site 7 ! cov]$ entity ) :i* su* subgrantee has an en=ceable writt5 agreem5t pursuant to clause 7i74 4 #h4 ,claims modifi]s2 cov]$ entity data submission ,section #cdj;,b7a77#e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77#e77 is fur!r am5d$ by add+ at ! end ! foll[+3 7,j7 ,claims modifi] & cov]$ entity data submission 7i7 ,claims modifi] ,all claims submitt$ to a payor1 includ+1 )\t limitation1 ,m$ic>e & ,m$icaid1 by a cov]$ entity or a contract ph>macy "u a contract ) a cov]$ entity 9 compliance ) subp>agraph 7,f7 = reimbursem5t ( a unit ( a cov]$ outpati5t drug pur*as$ "u ! program "u ?is section %all include ! relevant #cdj;,b modifi] e/abli%$ by ! ,secret>y "u ,m$ic>e ,"p ,b 7t is ,,jg1 ,,tb1 or any successor modifi]7 or ! ,submission ,cl>ification ,code ( #bj or any successor modifi] develop$ by ! ,national ,c\ncil = ,prescription ,drug ,programs 7,,ncpdp7 to id5tify claims = cov]$ outpati5t drugs pur*as$ "u su* program4 ,all claims submitt$ by a cov]$ entity or a contract ph>macy describ$ 9 ?is clause to a payor1 includ+1 )\t limitation1 ,m$ic>e & ,m$icaid1 = reimbursem5t ( a unit ( a cov]$ outpati5t drug n pur*as$ "u su* program %all also include a relevant non-#cdj;,b modifi]1 :i* %all be e/abli%$ by ! ,secret>y1 or a non-#cdj;,b modifi] develop$ by ! ,,ncpcp to id5tify su* claims4 7ii7 ,cov]$ entity data submission ,a cov]$ entity describ$ 9 p>agraph 7#d7 %all 7& %all cause any entity act+ on its behalf to7 furni% to ! cle>+h\se describ$ 9 subsection 7d77#b77;,c7 ! data describ$ 9 clause 7iii71 9 a ma*9e-readable =mat1 ) respect to ea* cov]$ outpati5t drug disp5s$1 furni%$1 or adm9i/]$ by ! cov]$ entity 7includ+ su* drugs disp5s$ by a contract ph>macy "u contract ) su* cov]$ entity 9 compliance ) subp>agraph 7,f771 = :i* su* cov]$ entity seeks or has receiv$ disc\nt$ pric+ "u ?is section4 ,su* cov]$ entity %all provide1 or cause to be provid$1 su* data to ! cle>+h\se )9 #de days aft] ! date on :i* ! cov]$ outpati5t drug 0 disp5s$1 furni%$1 or adm9i/]$ 7or su* %ort] "t p]iod z may be specifi$ by ! ,secret>y ?r\gh notice-&-comm5t rulemak+7 9 an electronic =mat specifi$ by ! ,secret>y4 ,! cov]$ entity %all require 7& %all cause any entity act+ on its behalf to require7 t data on ph>macy-disp5s$ drugs describ$ 9 ?is subp>agraph be submitt$ to ! cle>+h\se directly by ! ph>macy disp5s+ su* drug4 7iii7 ,claim level data elem5ts ,! data describ$ 9 ?is clause %all include ! foll[+1 z applicable3 7,i7 ,self-adm9i/]$ drugs ,) respect to a self-adm9i/]$ drug disp5s$ at a ph>macy1 by a mail ord] s]vice1 or by ano!r disp5s]-- 7aa7 prescription numb]2 7bb7 prescrib$ date2 7cc7 prescription fill date2 7dd7 national drug code 7,,ndc7 ( ! drug2 7ee7 quantity disp5s$2 7ff7 bank id5tification numb]1 processor control numb]1 & gr\p numb] ( ! plan receiv+ ! claim 7z applicable72 7gg7 national provid] id5tifi] 7,,npi7 ( ! prescrib]2 7hh7 ,,npi ( ! disp5s+ ph>macy2 7ii7 "n & #cdj;,b id5tifi] ( ! cov]$ entity disp5s+ ! drug1 or on ^: behalf ! drug is disp5s$2 7jj7 #cdj;,b_/non-#cdj;,b claim modifi]2 7kk7 :olesal] invoice numb]2 & 7ll7 an indicator1 :i* %all be specifi$ by ! cle>+h\se or ! ,secret>y1 d5ot+ t ! drug 0 or 0 n disp5s$ z a result ( c>e coord9ation describ$ 9 subsection 7b77#c74 7,,ii7 ,provid]-adm9i/]$ drugs ,) respect to a drug furni%$ or adm9i/]$ by a physician or o!r provid] ( s]vices or a suppli]-- 7aa7 drug bill+ & paym5t code_/,,hcpcs code2 7bb7 ,,ndc ( ! drug2 7cc7 claim numb]2 7dd7 ,m$ic>e provid] numb] ( prescrib] 7z applicable72 7ee7 ,,npi ( ! prescrib]2 7ff7 "n & #cdj;,b id5tifi] ( ! cov]$ entity furni%+ or adm9i/]+ ! drug2 7gg7 date drug furni%$ or adm9i/]$2 7hh7 claim adjudication date2 7ii7 quantity furni%$ or adm9i/]$2 7jj7 #cdj;,b_/non-#cdj;,b claim modifi]2 & 7kk7 an indicator1 :i* %all be specifi$ by ! cle>+h\se or ! ,secret>y1 d5ot+ t ! drug 0 or 0 n furni%$ or adm9i/]$ z a result ( c>e coord9ation describ$ 9 subsection 7b77#c74 7iv7 ,in=mation privacy & security ,a cov]$ entity describ$ 9 p>agraph 7#d7 %all provide ! data specifi$ 9 clause 7iii7 to ! cle>+h\se 9 a secure mann]1 consi/5t ) su* entity's obligations "u ! ,security ,/&>ds = ! ,protection ( ,electronic ,protect$ ,heal? ,in=mation describ$ 9 "p #afd ( subp>t ,c ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulations74 ,a cov]$ entity %all n be requir$ to obta9 an individual au?orization "u "p #afd ( subp>t ,e ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulations7 = its report+ ( su* data to ! cle>+h\se4 7v7 ,/&>dization ( report$ data elem5ts2 prohibition on modifications ,a cov]$ entity describ$ 9 p>agraph 7#d7 %all take reasonable /eps to ensure ! data specifi$ 9 clause 7iii7 submitt$ to ! cle>+h\se fully complies ) ! data submission /&>ds 7includ+ field descriptors & def9itions7 specifi$ by ! cle>+h\se or ! ,secret>y foll[+ consultation ) relevant /akehold]s1 includ+ manufactur]s ( cov]$ outpati5t drugs4 ,a cov]$ entity describ$ 9 p>agraph 7#d7 is prohibit$1 & %all prohibit any entity act+ on its behalf 7includ+ any affiliate ( su* entity71 f tak+ or refra9+ f tak+ any action t w\ld cause su* in=mation to no long] comply ) ! /&>ds describ$ 9 ?is clause4 ,9 specify+ ! data submission /&>ds describ$ 9 ?is clause1 ! cle>+h\se & ! ,secret>y1 z applicable1 %all seek to m9imize adm9i/rative burd5 on cov]$ entities :ile ensur+ su* data satisfies ! int5t ( ?is subp>agraph4 7vi7 ,cov]$ entities t fail to report ,a cov]$ entity t fails to furni% ! in=mation z requir$ "u ?is subp>agraph %all be subject to a civil monet>y p5alty 9 ! am\nt ( #b1ejj = ea* day ( su* violation1 :i* am\nt %all be adju/$ = inflation annually to reflect ! rate ( *ange 9 ! ,consum] ,price ,index = ,all ,urban ,consum]s publi%$ by ! ,bureau ( ,labor ,/ati/ics4 ,! provisions ( section #aabh;,a ( ! ,social ,security ,act 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$+ "u section #aabh;,a7a74 ,! ,(fice ( ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all c>ry out ! provisions ( ?is clause4 4 #i4 ,cov]$ entity report+ on scope ( grant1 contract1 & project ,section #cdj;,b7a77#e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77#e77 is fur!r am5d$ by add+ at ! end ! foll[+3 7,k7 ,report+ on scope ( grant1 contract1 & project ,a cov]$ entity describ$ 9 "o ( subp>agraphs 7,a7 ?r\gh 7,k7 ( p>agraph 7#d7 %all submit in=mation specifi$ by ! ,secret>y to ! id5tification sy/em describ$ 9 subsection 7d77#b77;,b77iv7 at lea/ annually1 9 a =m & mann] specifi$ by ! ,secret>y1 describ+ ! scope ( its ,f$]al grant or project1 or ! ,f$]al grant-au?oriz+ /atute1 z applicable1 t is ! basis = su* entity's eligibility = ! program "u ?is section4 ,su* in=mation %all include copies ( agreem5ts betwe5 su* entity & any subgrantee1 z describ$ 9 subp>agraph 7,i74 ,access to in=mation describ$ 9 ?is subp>agraph %all be made available to a manufactur] ( a cov]$ outpati5t drug1 ^u reque/1 9 a mann] specifi$ by ! ,secret>y4 4 #aj4 ,ensur+ cov]$ entity transp>5cy 7a7 ,9 g5]al ,section #cdj;,b7a77#e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77#e77 is fur!r am5d$ by add+ at ! end ! foll[+3 7,l7 ,report+ 7i7 ,9 g5]al ,dur+ ! fir/ ye> beg9n+ on or aft] ! date t is #ad mon?s aft] ! date ( enactm5t ( ?is subp>agraph & dur+ ea* subsequ5t ye>1 ea* cov]$ entity describ$ 9 subp>agraph 7,l7 ( p>agraph 7#d7 7& any o!r cov]$ entity specifi$ by ! ,secret>y7 %all report to ! ,secret>y 7at a "t & 9 a =m & mann] specifi$ by ! ,secret>y7 ! foll[+ in=mation ) respect to ! prec$+ ye>3 7,i7 ,) respect to su* cov]$ entity & ea* *ild site1 z applicable1 ( su* entity-- 7aa7 ! total numb] ( individuals :o 7 disp5s$ or adm9i/]$ cov]$ outpati5t drugs dur+ su* prec$+ ye> t 7 subject to an agreem5t "u ?is section2 & 7bb7 ! numb] ( su* individuals describ$ 9 a category specifi$ 9 clause 7iii71 brok5 d[n by ea* su* category4 7,,ii7 ,) respect to su* cov]$ entity & ea* *ild site1 z applicable1 ( su* entity-- 7aa7 ! p]c5tage ( ! total numb] ( individuals furni%$ items & s]vices dur+ su* prec$+ ye> :o 7 disp5s$ or adm9i/]$ cov]$ outpati5t drugs dur+ su* prec$+ ye> t 7 subject to an agreem5t "u ?is section2 & 7bb7 = ea* category specifi$ 9 clause 7iii71 ! p]c5tage ( ! total numb] ( individuals describ$ 9 su* category furni%$ items & s]vices dur+ su* prec$+ ye> :o 7 disp5s$ or adm9i/]$ cov]$ outpati5t drugs dur+ su* prec$+ ye> t 7 subject to an agreem5t "u ?is section4 7,,iii7 ,) respect to su* cov]$ entity & ea* *ild site1 z applicable1 ( su* entity1 ! total co/s incurr$ dur+ ! ye> at ea* su* site & ! co/ incurr$ at ea* su* site = *>ity c>e 7z def9$ 9 l9e #bc ( work%eet ,s-#aj to ! ,m$ic>e co/ report1 or 9 any successor =m74 7,,iv7 ,) respect to su* cov]$ entity & ea* *ild site1 z applicable1 ( su* entity1 ! co/s incurr$ dur+ ! ye> ( furni%+ items & s]vices at ea* su* entity or site to pati5ts ( su* entity :o 7 entitl$ to b5efits "u "p ,a ( title ,,xviii ( ! ,social ,security ,act or enroll$ "u "p ,b ( su* title1 enroll$ 9 a ,/ate plan "u title ,,xix ( su* ,act 7or a waiv] ( su* plan71 or :o 7 un9sur$ = s]vices1 m9us ! sum (-- 7aa7 paym5ts "u title ,,xviii ( su* ,act = su* items & s]vices 7includ+ any co/ %>+ = su* items & s]vices72 7bb7 paym5ts "u title ,,xix ( su* ,act = su* items & s]vices 7includ+ any co/ %>+ = su* items & s]vices72 & 7cc7 paym5ts by un9sur$ pati5ts = su* items & s]vices4 7,v7 ,) respect to su* cov]$ entity & ea* *ild site1 z applicable1 ( su* entity1 ! m>g9 7z def9$ 9 clause 7iv77 g5]at$ on cov]$ outpati5t drugs subject to an agreem5t "u ?is section disp5s$ or furni%$ by su* entity or site 7& any entity ph>macy or contract ph>macy disp5s+ su* drugs on behalf ( su* entity 9 accordance ) subp>agraph 7,f771 ) ea* compon5t ( ! m>g9 calculation describ$ 9 item 7aa7 ?r\gh 7cc7 ( su* clause li/$ z a sep>ate l9e item4 7,,vi7 ,to ! ext5t ! ,secret>y requires cov]$ entities describ$ 9 "o ( subp>agraphs 7,a7 ?r\gh 7,k7 ( p>agraph 7#d7 to report in=mation pursuant to ?is subp>agraph1 ) respect to ea* su* cov]$ entity1 use ( m>g9 7z def9$ 9 clause 7iv77 g5]at$ on cov]$ outpati5t drugs subject to an agreem5t "u ?is section 9 ! foll[+ categories ( exp5ditures1 if applicable1 :i* ! ,secret>y %all def9e 9 int]im f9al regulations 9 a mann] consi/5t ) report+ "u ! ,heal? ,res\rces & ,s]vices ,adm9i/ration ,uni=m ,data ,sy/em 7,,uds7-- 7aa7 m$ical c>e2 7bb7 d5tal c>e2 7cc7 m5tal heal?2 7dd7 ph>maceuticals1 :i* %all include m>g9 us$ to provide free & disc\nt$ cov]$ outpati5t drugs subject to an agreem5t "u ?is section disp5s$ or furni%$ to eligible pati5ts 7z def9$ 9 subp>agraph 7,h771 not)/&+ any ,,uds report+ requirem5t t may limit or int]f]e ) ! inclusion ( m>g9 us$ = su* purpose2 7ee7 slid+ fee disc\nts2 7ff7 case managem5t2 7gg7 transportation2 7hh7 pati5t & community education2 7ii7 community heal? work]s2 7jj7 outrea*2 7kk7 eligibility assi/ance2 & 7ll7 nutritional assessm5t & ref]ral4 7ii7 ,publication ,! ,secret>y %all publi% data report$ "u clause 7i7 ) respect to a ye> annually on ! public website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices 9 an electronic & se>*able =mat1 :i* may include ! #cdj;,b ,(fice ( ,ph>macy ,affairs ,in=mation ,sy/em 7or a successor to su* sy/em71 9 a mann] t %[s ea* category ( data report$ 9 ! aggregate & id5tifi$ by ! specific cov]$ entity submitt+ su* data4 ,! ,secret>y %all include 9 su* publication ! disproportionate pati5t p]c5tage 7z def9$ 9 section #ahhf7;d77#e77;,f77vi7 ( ! ,social ,security ,act7 ( ea* su* cov]$ entity 7if applicable7 = ea* co/ report+ p]iod occurr+ dur+ su* ye>4 7iii7 ,categories specifi$ ,= purposes ( clause 7i71 ! categories specifi$ 9 ?is clause are ! foll[+3 7,i7 ,individuals cov]$ "u a gr\p heal? plan or gr\p or individual heal? insurance cov]age 7z su* t]ms are def9$ 9 section #bgia74 7,,ii7 ,individuals entitl$ to b5efits "u "p ,a or enroll$ "u "p ,b ( title ,,xviii ( ! ,social ,security ,act4 7,,iii7 ,individuals enroll$ "u a ,/ate plan "u title ,,xix ( su* ,act 7or a waiv] ( su* plan74 7,,iv7 ,individuals enroll$ "u a ,/ate *ild heal? plan "u title ,,xxi ( su* ,act 7or a waiv] ( su* plan74 7,v7 ,individuals n describ$ 9 any prec$+ subclause & n cov]$ "u any ,f$]al heal? c>e program 7z def9$ 9 section #aabh;,b ( su* ,act b includ+ ! program e/abli%$ "u *apt] #hi ( title #e1 ,unit$ ,/ates ,code74 7iv7 ,def9itions ,9 ?is subp>agraph3 7,i7 ,*ild site ,! t]m *ild site %all h ! mean+ giv5 su* t]m 9 subp>agraph 7,e74 7,,ii7 ,entity ph>macy ,! t]m entity ph>macy %all h ! mean+ giv5 su* t]m 9 subp>agraph 7,f74 7,,iii7 ,m>g9 ,! t]m m>g9 means1 ) respect to cov]$ outpati5t drugs pur*as$ by a cov]$ entity "u an agreem5t "u ?is section1 ! foll[+ am\nt = su* drugs disp5s$1 furni%$1 or adm9i/]$ to an individual by su* entity or a *ild site ( su* entity 7& any entity ph>macy or contract ph>macy disp5s+ su* drugs on behalf ( su* entity 9 accordance ) subp>agraph 7,f77-- 7aa7 aggregate paym5ts receiv$ by ! cov]$ entity = su* drugs f individuals 7includ+ co/-%>+ am\nts7 & ?ird p>ties1 includ+ gov]nm5t & private payors2 7bb7 aggregate co/s to acquire su* drugs at ei!r ! ceil+ price describ$ 9 p>agraph 7#a7 or any volunt>y subceil+ price at :i* ! cov]$ entity pur*as$ su* drug or drugs1 z applicable2 m9us 7cc7 aggregate co/s incurr$ by ! cov]$ entity t are necess>y = su* entity to p>ticipate 9 ! program "u ?is section & to comply ) su* program's requirem5ts1 includ+ program-relat$ compliance1 legal1 educational1 & adm9i/rative co/s 7su* co/s %all be det]m9$ 9 accordance ) ,g5]ally ,accept$ ,acc\nt+ ,pr9ciples71 & comp5sation paid to ?ird-p>ty adm9i/rators or contract ph>macies to c>ry out program-relat$ functions4 4 7b7 ,rulemak+ ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all issue an int]im f9al rule to c>ry out section #cdj;,b7a77#e77,l7 ( ! ,public ,heal? ,s]vice ,act1 z add$ by subsection 7a74 #aa4 ,revisions to exi/+ #cdj;,b hospital eligibility requirem5ts ,section #cdj;,b7a77#d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77#d77 is am5d$-- 7#a7 9 subp>agraph 7,l77i7-- 7,a7 by ins]t+ & t 0 regi/]$ ) ! #cdj;,b program 9 ! cov]$ entity id5tification sy/em e/abli%$ "u subsection 7d77#b77;,b77iv7 z su* a hospital on or be=e ,decemb] #a1 #bjbd aft] =mally grant$ gov]nm5tal p[]s by a unit ( /ate or local gov]nm5t2 & 7,b7 by /rik+ n entitl$ to b5efits "u title ,,xviii ( ! ,social ,security ,act & all t foll[s up to ! semicolon at ! end & ins]t+ un9sur$1 z su* t]ms are def9$ 9 subsection 7a77#aa72 7#b7 by am5d+ subp>agraph 7,n7 to read z foll[s3 7,n7 ,an entity t is a critical access hospital 7z det]m9$ "u section #ahbj7;c77#b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;i-#d7;c77#b777 or a rural em]g5cy hospital 7z det]m9$ "u ! requirem5ts 9 section #ahfa7kkk7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciex7kkk7 & 9 implem5t+ regulations set =? 9 p>ts #dai1 #dbd1 #dhe1 #dhh1 & #dhi ( title #db ( ! ,code ( ,f$]al ,regulations 9 effect z ( ,janu>y #a1 #bjbd771 & t meets ! requirem5ts ( subp>agraph 7,l77i74 2 & 7#c7 9 subp>agraph 7,o7 by ins]t+ t demon/rates to ! ,secret>y t at lea/ #fj p]c5t ( annual inpati5t dis*>ges = co/ report+ p]iods beg9n+ aft] ,decemb] #a1 #bjbd1 are = inpati5ts :o reside 9 a c\nty t is n "p ( a ,metropolitan ,/ati/ical ,area1 z def9$ by ! ,director ( ! ,(fice ( ,managem5t & ,budget be=e 1 or a sole community hospital4 #ab4 ,additional requirem5ts = #cdj;,b hospitals ,section #cdj;,b7a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77 is am5d$ by add+ at ! end ! foll[+3 7#aa7 ,cl>ification ( eligibility /&>ds = private nonpr(it hospitals ) a contract ) a ,/ate or local gov]nm5t to provide heal? c>e s]vices 7,a7 ,contract requirem5ts ,= purposes ( p>agraph 7#d77,l77i7 & cross-ref]5ces to subp>agraph 7,l7 or clause 7i7 ( su* p>agraph appe>+ 9 subp>agraph 7,m7 & subp>agraph 7,o7 ( su* p>agraph ) respect to a rural ref]ral c5t]1 a private nonpr(it hospital has a contract ) a ,/ate or local gov]nm5t to provide heal? c>e s]vices to l[-income individuals :o are un9sur$ if-- 7i7 ! hospital submits a copy ( ! contract 7includ+ any app5dices or add5da or subsequ5t am5dm5ts7 to ! ,secret>y = review2 7ii7 ! ,secret>y det]m9es t ! contract creates an en=ceable obligation = ! hospital to provide direct m$ical c>e to l[-income individuals :o are un9sur$ 9 an am\nt t repres5ts at lea/ #aj p]c5t ( ! hospital's total co/s ( c>e2 7iii7 ! ,secret>y fur!r det]m9es1 bas$ on a review ( ! contract 7z describ$ 9 clause 7i77 t ! contract creates an en=ceable obligation = ! hospital to furni% ! individuals describ$ 9 clause 7ii7 ! full range ( s]vices provid$ at ! hospital 7includ+ any *ild sites72 & 7iv7 ! contract 7z describ$ 9 clause 7i77 is available to ! public z "p ( ! in=mation describ+ ! hospital 9 ! cov]$ entity id5tification sy/em e/abli%$ "u subsection 7d77#b77;,b77iv74 7,b7 ,d]egi/ration ,if at any "t a hospital n own$ or op]at$ by a unit ( ,/ate or local gov]nm5t t has be5 p>ticipat+ 9 ! program "u ?is section on ! basis ( hav+ a contract ) a ,/ate or local gov]nm5t to provide heal? c>e s]vices t is subject to subp>agraph 7,a7 no long] satisfies a requirem5t "u su* subp>agraph1 ! hospital %all imm$iately notify ! ,secret>y t ! hospital no long] satisfies ! relevant requirem5t1 d]egi/] ! hospital f ! program "u ?is section & ! id5tification sy/em describ$ 9 subsection 7d77#b77;,b77iv71 & cease mak+ pur*ases "u su* program & repres5t+ to ?ird p>ties t x may pur*ase "u su* program4 7,c7 ,obligation to self-disclose ,a cov]$ entity describ$ 9 subp>agraph 7,b7 %all imm$iately disclose to ! ,secret>y & ! manufactur] ( ! affect$ cov]$ outpati5t drug any pur*ase made "u ! program "u ?is section by su* cov]$ entity t1 at ! "t ( ! pur*ase ( su* drug1 did n fully satisfy ! requirem5ts 9 subp>agraph 7,a74 ,any su* pur*ase %all require ! cov]$ entity to promptly conduct an audit sup]vis$ by ! ,secret>y to id5tify ! full scope ( noncompliance ) su* requirem5ts & to provide ! writt5 results ( su* audit to ! ,secret>y & ! manufactur] ( ! affect$ cov]$ outpati5t drug4 ,! cov]$ entity %all be liable to ! manufactur] ( ! cov]$ outpati5t drug t is ! subject ( ! noncompliance 9 an am\nt equal to ! r$uction 9 ! price ( ! drugs provid$ "u subsection 7a77#a71 plus int]e/ on su* am\nt1 :i* %all be comp\nd$ mon?ly & equal to ! curr5t %ort-t]m int]e/ rate z det]m9$ by ! ,f$]al ,res]ve = ! "t p]iod = :i* ! cov]$ entity is liable4 7,d7 ,civil monet>y p5alty ,:]e a cov]$ entity fails to satisfy a requirem5t 9 subp>agraph 7,b7 or 7,c71 ! cov]$ entity %all be requir$ to pay a civil monet>y p5alty equal to #b1ejj = ea* violation1 :i* am\nt %all be adju/$ = inflation annually to reflect ! rate ( *ange 9 ! ,consum] ,price ,index = ,all ,urban ,consum]s publi%$ by ! ,bureau ( ,labor ,/ati/ics4 ,! provisions ( section #aabh;,a ( ! ,social ,security ,act 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil monet>y p5alty "u ?is subp>agraph 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 ,! ,(fice ( ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all c>ry out ! provisions relat$ to ! imposition ( civil monet>y p5alties "u ?is subp>agraph4 7,e7 ,def9itions ,9 ?is p>agraph3 7i7 ,f$]al pov]ty guidel9es ,! t]m ,f$]al pov]ty guidel9es means ! pov]ty guidel9es updat$ p]iodically 9 ! ,f$]al ,regi/] by ! ,dep>tm5t ( ,heal? & ,human ,s]vices pursuant to section #iijb7b7 ( title #db1 ,unit$ ,/ates ,code4 7ii7 ,l[-income individual ,! t]m l[-income individual means an individual ) family income at or bel[ #bjj p]c5t ( ! ,f$]al pov]ty guidel9es4 7iii7 ,un9sur$ ,! t]m un9sur$ means lack+ m9imum ess5tial cov]age1 z def9$ 9 subsection #ejjj;,a7f7 ( ! ,int]nal ,rev5ue ,code 7#bf ,u4,s4,c4 #ejjj;,a7f77 & implem5t+ regulations4 7#ab7 ,additional requirem5t = private nonpr(it disproportionate %>e hospitals locat$ 9 urban areas 7,a7 ,9 g5]al ,a cov]$ entity describ$ 9 p>agraph 7#d77,l77i7 t is ei!r a private nonpr(it hospital t has z ! basis = its p>ticipation 9 ! program "u ?is section a contract ) a ,/ate or local gov]nm5t z describ$ 9 su* p>agraph & 9 p>agraph 7#aa71 or t is a private nonpr(it corporation :i* is =mally grant$ gov]nm5tal p[]s by a unit ( ,/ate or local gov]nm5t1 & su* entity is locat$ 9 a c\nty t is "p ( a ,metropolitan ,/ati/ical ,area1 z def9$ by ! ,(fice ( ,managem5t & ,budget1 mu/1 = ! prec$+ ye>1 fall )9 ! top #dj p]c5t ( hospitals on ea* ( ! li/s describ$ 9 subp>agraphs 7,b7 & 7,c7 prep>$ by ! ,secret>y ) respect to ! ,/ate 9 :i* ! cov]$ entity is locat$4 ,z describ$ fur!r 9 subp>agraph 7,d71 placem5t 9 ! top #dj p]c5t ( hospitals on bo? ( su* li/s is a condition ( su* cov]$ entity's p>ticipation 9 ! program "u ?is section & failure to meet ?is condition %all require d]egi/ration & self-disclosure us+ ! proc$ures describ$ 9 subp>agraphs 7,b7 & 7,c7 ( p>agraph 7#aa74 ,su* cov]$ entity %all be subject to a civil monet>y p5alty describ$ 9 p>agraph 7#aa77;,d7 = failure to d]egi/] & self-disclose 9 accordance ) ! prec$+ s5t5ce4 7,b7 ,m$icaid & ,,*ip outpati5t rev5ue ,)9 #ij days foll[+ ! conclusion ( a ye>1 ! ,secret>y %all prep>e & make available to ! public 9 an electronic1 ma*9e-readable =mat = ea* ,/ate = ! conclud$ ye>1 a li/ t ranks all acute c>e hospitals 9 su* ,/ate 9 desc5d+ ord] bas$ on ea* hospital's %>e ( total outpati5t s]vices rev5ue d]iv$ f base reimbursem5t to su* hospital 7exclud+ supplem5tal & indirect reimbursem5t7 "u title ,,xix ( ! ,social ,security ,act 7includ+ ) respect to individuals also entitl$ to b5efits "u "p ,a ( title ,,xviii ( su* ,act or enroll$ 9 "p ,b ( title ,,xviii ( su* ,act7 & paym5ts "u title ,,xxi ( su* ,act = items & s]vices furni%$ on an outpati5t basis at ! hospital 7includ+ any co/ %>+ = su* items & s]vices74 ,! ,secret>y %all specify ! ?re%old = ! top #dj p]c5t ( hospitals on ! li/4 7,c7 ,uncomp5sat$ outpati5t c>e ,)9 #ij days foll[+ ! conclusion ( a ye>1 ! ,secret>y %all prep>e & make available to ! public 9 an electronic1 ma*9e-readable =mat = ea* ,/ate = ! conclud$ ye>1 a li/ t ranks all acute c>e hospitals 9 su* ,/ate 9 desc5d+ ord] bas$ on ea* hospital's total co/ ( uncomp5sat$ c>e = items & s]vices furni%$ on an outpati5t basis z a %>e ( ! hospital's total outpati5t s]vices rev5ue4 ,= purposes ( ?is li/1 co/s ( uncomp5sat$ outpati5t c>e %all be det]m9$ 9 a mann] consi/5t ) ! in/ructions on work%eet ,s-#aj to ! ,m$ic>e co/ report 7or any successor =m71 ) adju/m5ts to limit uncomp5sat$ outpati5t c>e co/s to ^? incurr$ 9 provid+ items & s]vices on an outpati5t basis at ! hospital4 ,! ,secret>y %all specify ! ?re%old = ! top #dj p]c5t ( hospitals on ! li/4 7,d7 ,d]egi/ration ,)9 #cj days foll[+ ! ,secret>y's publication ( ! li/s describ$ 9 subp>agraphs 7,b7 & 7,c71 ea* cov]$ entity subject to ?is p>agraph t is n includ$ 9 ! top #dj p]c5t ( hospitals on bo? li/s %all notify ! ,secret>y t ! cov]$ entity does n satisfy "o or m requirem5ts describ$ 9 ?is p>agraph1 d]egi/] ! entity f ! program "u ?is section & ! id5tification sy/em describ$ 9 subsection 7d77#b77;,b77iv71 & cease mak+ pur*ases "u su* program & repres5t+ to ?ird p>ties t x may pur*ase "u su* program4 ,su* an entity may seek to regi/] "u ano!r cov]$ entity category describ$ 9 p>agraph 7#d7 if su* entity meets ! crit]ia = su* a category & applicable requirem5ts "u ?is section4 7,e7 ,obligation to self-disclose ,a cov]$ entity describ$ 9 subp>agraph 7,d7 %all imm$iately disclose to ! ,secret>y & ! manufactur] ( ! affect$ cov]$ outpati5t drug any pur*ase made "u ! program "u ?is section by su* cov]$ entity t1 at ! "t ( ! pur*ase ( su* drug1 did n fully satisfy ! requirem5ts 9 subp>agraphs 7,b7 & 7,c74 ,any su* pur*ase %all require ! cov]$ entity to promptly conduct an audit sup]vis$ by ! ,secret>y to id5tify ! full scope ( noncompliance ) su* requirem5ts & to provide ! writt5 results ( su* audit to ! ,secret>y & ! manufactur] ( ! affect$ cov]$ outpati5t drug4 ,! cov]$ entity %all be liable to ! manufactur] ( ! cov]$ outpati5t drug t is ! subject ( ! noncompliance 9 an am\nt equal to ! r$uction 9 ! price ( ! drugs provid$ "u p>agraph 7#a71 plus int]e/ on su* am\nt1 :i* %all be comp\nd$ mon?ly & equal to ! curr5t %ort-t]m int]e/ rate z det]m9$ by ! ,f$]al ,res]ve = ! "t p]iod = :i* ! cov]$ entity is liable4 7,f7 ,civil monet>y p5alty ,:]e a cov]$ entity fails to satisfy a requirem5t 9 subp>agraph 7,d7 or 7,e71 ! cov]$ entity %all be requir$ to pay a civil monet>y p5alty equal to #b1ejj = ea* violation1 :i* am\nt %all be adju/$ = inflation annually to reflect ! rate ( *ange 9 ! ,consum] ,price ,index = ,all ,urban ,consum]s publi%$ by ! ,bureau ( ,labor ,/ati/ics4 ,! provisions ( section #aabh;,a ( ! ,social ,security ,act 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil monet>y p5alty "u ?is subp>agraph 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 ,! ,(fice ( ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all c>ry out ! provisions relat$ to ! imposition ( civil monet>y p5alties "u ?is subp>agraph4 7#ac7 ,prohibition aga9/ extraord9>y collection actions 7,a7 ,e,c,as prohibit$ ,a cov]$ entity describ$ 9 subp>agraphs 7,l7 ?r\gh 7,o7 ( p>agraph 7#d7 is prohibit$ f engag+ 9 extraord9>y collection actions 7,e,c,as71 z su* t]m is describ$ 9 section #eja7r77#f7 ( ! ,int]nal ,rev5ue ,code & its implem5t+ regulations set =? 9 section #a4eja7r7-#f ( title #bf ( ! ,code ( ,f$]al ,regulations 7or any successor regulations71 ) respect to heal? c>e items & s]vices furni%$ to un9sur$ individuals or l[-income individuals4 7,b7 ,audits ,! ,secret>y %all audit = cov]$ entity compliance ) ?is p>agraph1 e/abli% a process = individuals to report suspect$ violations ( ?is p>agraph to ! ,secret>y1 & promptly & fully inve/igate su* reports ( suspect$ violations4 7,c7 ,civil monet>y p5alty ,:]e a cov]$ entity violates ! prohibition 9 ?is p>agraph1 ! cov]$ entity %all be requir$ to pay a civil monet>y p5alty equal to #b1ejj = ea* extraord9>y collection action tak5 ) respect to an individual describ$ 9 ?is p>agraph1 :i* am\nt %all be adju/$ = inflation annually to reflect ! rate ( *ange 9 ! ,consum] ,price ,index = ,all ,urban ,consum]s publi%$ by ! ,bureau ( ,labor ,/ati/ics4 ,! provisions ( section #aabh;,a ( ! ,social ,security ,act 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil monet>y p5alty "u ?is p>agraph 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 ,! ,(fice ( ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all c>ry out ! provisions relat$ to ! imposition ( civil monet>y p5alties "u ?is p>agraph4 7,d7 ,def9itions ,9 ?is p>agraph1 ! t]ms l[-income individual & un9sur$ h ! mean+s giv5 su* t]ms 9 p>agraph 7#aa74 7#ad7 ,additional requirem5t = c]ta9 hospitals 7,a7 ,9 g5]al ,dur+ ! fir/ cal5d> ye> beg9n+ on or aft] ! date t is #bd mon?s aft] ! date ( enactm5t ( ?is p>agraph & dur+ ea* subsequ5t cal5d> ye>1 a cov]$ entity describ$ 9 p>agraph 7#d77,l7 %all det]m9e by ,octob] #a ( ea* su* ye>1 bas$ on ! mo/ rec5t ye> ( data x has report$ to ! ,secret>y "u p>agraph 7#e77,l7 at t po9t 9 "t1 :e!r ! annual *>ity c>e co/s x incurr$ = ! ye> report$ 7 great] ?an or equal to ! m>g9 x realiz$ "u ! program "u ?is section = t same ye>4 ,z describ$ fur!r 9 subp>agraph 7,d71 = ! p]iod specifi$ 9 ! prec$+ s5t5ce1 hav+ annual *>ity c>e co/s t equal or exce$ ! m>g9 = ! mo/ rec5tly report$ ye> is a condition ( su* cov]$ entity's p>ticipation 9 ! program "u ?is section = ! upcom+ cal5d> ye>1 & failure to meet ?is condition %all require d]egi/ration & self-disclosure us+ ! proc$ures describ$ 9 subp>agraphs 7,d7 & 7,e74 ,su* cov]$ entity %all be subject to a civil monet>y p5alty describ$ 9 subp>agraph 7,f7 = failure to d]egi/] & self-disclose 9 accordance ) ! prec$+ s5t5ce4 7,b7 ,annual *>ity c>e co/s ,! t]m annual *>ity c>e co/s means ! total co/s incurr$ dur+ ! ye> by ! cov]$ entity & its *ild sites 7z def9$ 9 p>agraph 7#e77;,e77i77 = *>ity c>e 7z def9$ 9 l9e #bc ( work%eet ,s-#aj to ! ,m$ic>e co/ report1 or 9 any successor =m74 7,c7 ,m>g9 ,! t]m m>g9 means ! m>g9 report$ by ! cov]$ entity = ! ye> pursuant to p>agraph 7#e77,l77i77,v74 7,d7 ,d]egi/ration & conditions = subsequ5t regi/ration 7i7 ,de-regi/ration ,on ,octob] #a ( ea* ye> beg9n+ on or aft] ! date t is #bd mon?s aft] ! date ( enactm5t ( ?is p>agraph1 ea* cov]$ entity subject to ?is p>agraph t has report$ at lea/ "o ye> ( data to ! ,secret>y "u p>agraph 7#e77,l7 & t does n h1 = ! mo/ rec5tly report$ ye>1 annual *>ity c>e co/s great] ?an or equal to ! m>g91 %all notify ! ,secret>y t x does n meet ! condition ( p>ticipation "u ?is p>agraph = ! upcom+ cal5d> ye>1 d]egi/] ! entity f ! program "u ?is section & ! id5tification sy/em describ$ 9 subsection 7d77#b77;,b77iv7 = ! upcom+ cal5d> ye>1 cease mak+ pur*ases "u su* program z ( ! />t ( ! upcom+ cal5d> ye>1 cease repres5t+ to ?ird p>ties t x may pur*ase "u su* program beyond ! curr5t cal5d> ye>1 & refra9 f pur*as+ cov]$ outpati5t drugs "u ?is section 9 quantities exce$+ su* entity's bona fide ne$s = ! rema9d] ( ! curr5t cal5d> ye>4 7ii7 ,regi/ration foll[+ de-regi/ration 7,i7 ,regi/ration "u ano!r cov]$ entity category ,a cov]$ entity t mu/ d]egi/] "u ?is subp>agraph %all n be prohibit$ f regi/]+ to p>ticipate 9 ! program "u ?is section "u ano!r cov]$ entity category describ$ 9 p>agraph 7#d7 if su* entity meets ! crit]ia = su* a category & applicable requirem5ts "u ?is section4 7,,ii7 ,regi/ration "u p>agraph 7#d77,l7 ,9 ord] to regi/] "u p>agraph 7#d77,l71 a hospital t has be5 requir$ to d]egi/] "u ?is subp>agraph mu/ demon/rate to ! ,secret>y 79 a =m & mann] specifi$ by ! ,secret>y1 & 9 addition to demon/rat+ t x satisfies ! o!r applicable regi/ration crit]ia "u p>agraph 7#d77,l77 t its annual *>ity c>e co/ 7z def9$ 9 subp>agraph 7,b77 = ! mo/ rec5t ye> t ! hospital w\ld h report$ "u p>agraph 7#d77,l7 abs5t ! d]egi/ration exce$$ by at lea/ "o p]c5t po9t ! annual *>ity c>e co/ = ! ye> prec$+ d]egi/ration by ! hospital4 ,if ! hospital is f\nd to meet ?is requirem5t & approv$ by ! ,secret>y = regi/ration "u p>agraph 7#d77,l71 !n ! hospital w be requir$ to resume report+ "u p>agraph 7#e77,l7 & 7once ! entity has report$ at lea/ "o ye> ( data to ! ,secret>y "u p>agraph 7#e77,l77 to meet ! condition ( p>ticipation describ$ 9 ?is p>agraph = ! mo/ rec5tly report$ ye> z ( ,octob] #a ( ea* ye>4 7,e7 ,obligation to self-disclose ,a cov]$ entity describ$ 9 subp>agraph 7,d7 %all imm$iately disclose to ! ,secret>y & ! manufactur] ( ! affect$ cov]$ outpati5t drug any pur*ase x made "u ?is section dur+ a cal5d> ye> 9 :i* x 0 ineligible to p>ticipate 9 ! program "u ?is section4 ,any su* pur*ase %all require ! cov]$ entity promptly to conduct an audit sup]vis$ by ! ,secret>y to id5tify ! full scope ( noncompliance & to provide ! writt5 results ( su* audit to ! ,secret>y & ! manufactur] ( ! affect$ cov]$ outpati5t drug4 ,! cov]$ entity %all be liable to ! manufactur] ( ! cov]$ outpati5t drug t is ! subject ( ! noncompliance 9 an am\nt equal to ! r$uction 9 ! price ( ! drugs provid$ "u p>agraph 7#a71 plus int]e/ on su* am\nt1 :i* %all be comp\nd$ mon?ly & equal to ! curr5t %ort-t]m int]e/ rate z det]m9$ by ! ,f$]al ,res]ve = ! "t p]iod = :i* ! cov]$ entity is liable4 7,f7 ,civil monet>y p5alty ,:]e a cov]$ entity fails to satisfy a requirem5t 9 subp>agraph 7,d7 or 7,e71 ! cov]$ entity %all be requir$ to pay a civil monet>y p5alty equal to #b1ejj = ea* violation1 :i* am\nt %all be adju/$ = inflation annually to reflect ! rate ( *ange 9 ! ,consum] ,price ,index = ,all ,urban ,consum]s publi%$ by ! ,bureau ( ,labor ,/ati/ics4 ,! provisions ( section #aabh;,a ( ! ,social ,security ,act 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil monet>y p5alty "u ?is subp>agraph 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 ,! ,(fice ( ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all c>ry out ! provisions relat$ to ! imposition ( civil monet>y p5alties "u ?is subp>agraph4 4 #ac4 #cdj;,b program ,section #cdj;,b7a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77 is fur!r am5d$ by add+ at ! end ! foll[+3 7#ae7 #cdj;,b program ,! int5t ( ?is section is to provide = manufactur] price r$uctions t enable cov]$ entities1 ^: mission is to s]ve und]s]v$ or o!rwise vuln]able communities1 to increase access to af=dable drugs & heal? s]vices = ^! communities4 4 #ad4 ,audits ( private nonhospital contracts ) ,/ate & local gov]nm5ts ,section #cdj;,b7d77#b77;,b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7d77#b77;,b77 is am5d$ by add+ at ! end ! foll[+3 7vi7 ,! conduct+ ( annual audits by ! ,secret>y ( contracts betwe5 a cov]$ entity describ$ 9 subp>agraph 7,l7 or subp>agraph 7,m7 ( subsection 7a77#d71 or subp>agraph 7,o7 ( su* subsection ) respect to a rural ref]ral c5t]1 t is a private nonpr(it hospital subject to ! requirem5ts 9 subsections 7a77#d77,l77i7 & 7a77#aa7 & a ,/ate or local gov]nm5t = at lea/ #aj p]c5t ( all su* entities p>ticipat+ 9 ! program "u ?is section4 ,! ,secret>y %all develop & publicly disclose /&>ds us$ to det]m9e :e!r su* contracts satisfy ! applicable requirem5ts describ$ 9 subsections 7a77#d77,l77i7 & 7a77#aa7 & publicly disclose ! f9d+s f su* audits4 ,! ,secret>y %all remove f ! program "u ?is section any su* entity t does n h a contract 9 effect ) a ,/ate or local gov]nm5t t satisfies ! applicable requirem5ts set =? 9 subsections 7a77#d77,l77i7 & 7a77#aa71 & su* removal %all require su* cov]$ entity to promptly conduct an audit sup]vis$ by ! ,secret>y to id5tify disc\nts on cov]$ outpati5t drugs pur*as$ at a disc\nt "u ?is section to :i* su* cov]$ entity 0 n eligible & provide ! writt5 results ( su* audit to ! ,secret>y & ! manufactur] ( ! affect$ cov]$ outpati5t drug4 ,su* cov]$ entity %all be liable to ! manufactur] ( su* cov]$ outpati5t drug 9 an am\nt equal to ! r$uction 9 ! price ( ! drugs provid$ "u subsection 7a77#a71 plus int]e/ on su* am\nt1 :i* %all be comp\nd$ mon?ly & equal to ! curr5t %ort-t]m int]e/ rate z det]m9$ by ! ,f$]al ,res]ve = ! "t p]iod = :i* ! cov]$ entity is liable4 ,:]e a cov]$ entity describ$ 9 ?is clause kn[+ly & int5tionally violates a requirem5t 9 subsection 7a77#d77,l77i7 or 7a77#aa71 ! cov]$ entity %all be requir$ to pay a civil monet>y p5alty equal to #a1jjj = ea* claim = a cov]$ outpati5t drug t is subject to ! violation1 :i* am\nt %all be adju/$ = inflation annually to reflect ! rate ( *ange 9 ! ,consum] ,price ,index = ,all ,urban ,consum]s publi%$ by ! ,bureau ( ,labor ,/ati/ics4 ,! provisions ( section #aabh;,a ( ! ,social ,security ,act 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$+ "u section #aabh;,a7a74 ,! ,(fice ( ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all c>ry out ! provisions relat$ to ! imposition ( civil monet>y p5alties "u ?is clause4 4 #ae4 ,ensur+ cov]$ entity compliance ) transp>5cy requirem5ts ,section #cdj;,b7d77#b77;,b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7d77#b77;,b77 is fur!r am5d$ by add+ at ! end ! foll[+3 7vii7 ,! imposition ( civil monet>y p5alties 9 am\nts det]m9$ appropriate by ! ,secret>y 9 ! case t ! ,secret>y det]m9es t a cov]$ entity is n 9 compliance ) subsection 7a77#e77,l74 4 #af4 #cdj;,b claims data cle>+h\se 7a7 #cdj;,b claims data cle>+h\se ,section #cdj;,b7d77#b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7d77#b77 is am5d$ by add+ at ! end ! foll[+3 7,c7 #cdj;,b claims data cle>+h\se 7i7 ,9 g5]al ,! improvem5ts describ$ 9 subp>agraph 7,a7 %all include ! e/abli%m5t ( a claims data cle>+h\se describ$ 9 ?is subp>agraph4 ,n lat] ?an "o ye> aft] ! date ( enactm5t ( ?is subp>agraph1 ! ,secret>y %all ent] into a contract ) a ?ird-p>ty entity t meets ! crit]ia specifi$ 9 clause 7ii7 7su* entity is h]e9aft] ref]r$ to z ! cle>+h\se7 = purposes (-- 7,i7 id5tify+ claims = cov]$ outpati5t drugs pur*as$ "u ! program "u ?is section = :i* reimbursem5t 0 made "u a ,/ate plan 7or waiv] ( su* plan7 & ensur+ su* claims are or 7 n includ$ 9 any ,/ate rebate reque/ "u section #aibg ( ! ,social ,security ,act 9 violation ( sections #aijc7m77#b77;,a77xiii7 or #aibg7;j77#a7 ( su* ,act or section #cdj;,b7a77#e77;,a7 ( ?is ,act2 7,,ii7 id5tify+ claims = cov]$ outpati5t drugs pur*as$ "u ! program "u ?is section t are select$ drugs 7z def9$ 9 section #aaib7;c7 ( ! ,social ,security ,act7 & ensur+ t1 = ea* su* claim1 ! nonduplication requirem5ts ( section #aaic7;d7 ( su* ,act h be5 met2 7,,iii7 id5tify+ claims = cov]$ outpati5t drugs pur*as$ "u ! program "u ?is section t are ei!r ,"p ,b rebatable drugs or ,"p ,d rebatable drugs & provid+ all relevant in=mation reg>d+ su* claims to ! ,secret>y to ensure t claims t are subject to a disc\nt "u ! program "u ?is section are exclud$ f inflation rebate calculations pursuant to section #ahdg;,a7i77#c77;,b77ii77,i7 ( ! ,social ,security ,act 7) respect to ,"p ,b rebatable drugs7 & section #ahfj;,d-#ad;,b7b77#a77;,b7 ( su* ,act 7) respect to ,"p ,d rebatable drugs72 7,,iv7 id5tify+ duplicate claims = a rebate or disc\nt submitt$ by two or m cov]$ entities 7or an entity or entities act+ on _! behalf7 ) respect to ! same unit ( a cov]$ outpati5t drug pur*as$ "u ! program "u ?is section & implem5t+ a process to ensure a manufactur] ( su* a drug does n pay m ?an "o rebate or disc\nt "u ?is section ) respect to su* unit2 & 7,v7 provid+ to manufactur]s ( cov]$ outpati5t drugs1 9 a =m & mann] specifi$ by ! ,secret>y 9 consultation ) manufactur]s1 access to ! data describ$ 9 subsection 7a77#e77;,j7 ) respect to ea* disp5se or adm9i/ration ( a manufactur]'s cov]$ outpati5t drugs = :i* a cov]$ entity receives a disc\nt "u ?is section4 7ii7 ,crit]ia = cle>+h\se ,! crit]ia describ$ 9 ?is clause include ! foll[+3 7,i7 ,! cle>+h\se %all n be own$ by1 ov]se5 by1 or affiliat$ ) a cov]$ entity describ$ 9 subsection 7a77#d7 & %all n curr5tly be a p>ty to a contractual arrangem5t ) ! ,heal? ,res\rces & ,s]vices ,adm9i/ration4 7,,ii7 ,! cle>+h\se %all h demon/rat$ exp]i5ce adjudicat+ claims = heal? c>e items & s]vices 9 real "t = self- & provid]-adm9i/]$ drugs & work+ ) protect$ heal? in=mation & confid5tial pric+ in=mation4 7,,iii7 ,! cle>+h\se %all agree to confid5tiality obligations t prohibit ! cle>+h\se f us+ in=mation x receives "u ?is subp>agraph = any purpose o!r ?an a purpose set =? 9 ?is subp>agraph1 or disclos+ su* in=mation to any individual or entity o!r ?an ! ,secret>y1 provid$ ! ,secret>y %all n use su* in=mation = purposes ( mak+ reimbursem5t or cov]age det]m9ations1 or a manufactur] 9 accordance ) ?is subp>agraph 7& only ) respect to su* manufactur]'s cov]$ outpati5t drugs74 7,,iv7 ,! cle>+h\se %all ma9ta9 ! security ( ! data report$ pursuant to ?is subsection 7a77#e77;,j7 9 a mann] consi/5t ) ! ,,hipaa ,security ,/&>ds set =? 9 sections #afd4cjd-afd4cab & #afd4caf ( title #de1 ,code ( ,f$]al ,regulations 7or any successor regulations71 z if ! cle>+h\se 7 subject to ^? /&>ds z a ,,hipaa cov]$ entity4 7iii7 ,duties ( cle>+h\se ,! cle>+h\se %all-- 7,i7 review claims level data = cov]$ outpati5t drugs describ$ 9 subsection 7a77#e77;,j7 submitt$ by cov]$ entities 9 accordance ) su* subsection2 7,,ii7 review claims level data1 includ+ rebate file data1 submitt$ to ! cle>+h\se by ,/ate ag5cies & ,m$icaid manag$ c>e organizations = cov]$ outpati5t drugs subject to an agreem5t "u ?is section disp5s$ or adm9i/]$ to individuals enroll$ "u a ,/ate plan 7or a waiv] ( su* plan7 & claims level data submitt$ by ,m$ic>e ,adm9i/rative ,contractors1 ,m$ic>e ,advantage organizations 7includ+ ,m$ic>e ,advantage ,organizations (f]+ an ,,ma-,,pd plan71 & ,,pdp sponsors = cov]$ outpati5t drugs subject to an agreem5t "u ?is section disp5s$ or adm9i/]$ to individuals enroll$ "u ,"p ,b1 ,"p ,c1 or ,"p ,d ( title ,,xviii ( ! ,social ,security ,act2 7,,iii7 )9 #e days ( id5tification1 provide writt5 notice ( a duplicate disc\nt or rebate to ! ,/ate ag5cy1 ! ,secret>y1 ! cov]$ entity1 & ! affect$ drug manufactur] itemiz+ any violation describ$ 9 clause 7i77,i72 7,,iv7 )9 #e days ( id5tification1 provide writt5 notice to ! ,secret>y1 ! cov]$ entity 7or entities1 z applicable71 & ! affect$ drug manufactur] itemiz+ any violation describ$ 9 subclauses 7,,ii7 or 7,,iv7 ( clause 7i72 7,v7 h access to ! int]net website describ$ 9 p>agraph 7#a77;,b77iii7 conta9+ applicable ceil+ prices = cov]$ outpati5t drugs = purposes ( id5tify+ violations describ$ 9 clause 7i77,,ii72 7,,vi7 subject to clauses 7i77,v7 & 7ii77,,iii71 make ! data describ$ 9 subclauses 7,i7 & 7,,ii7 available to ! manufactur] 9 electronic =mat n lat] ?an #aj days aft] su* data is provid$ to ! cle>+h\se2 7,,vii7 ^u reque/ by ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 make ! data describ$ 9 subclauses 7,i7 & 7,,ii7 available = purposes ( exclud+ #cdj;,b pur*as$ units ( ,"p ,b rebatable drugs or ,"p ,d rebatable drugs f ,"p ,b or ,"p ,d inflation rebates pursuant to section #ahdg;,a7i77#c77;,b77ii77,i7 or section #ahfj;,d-#ad;,b7b77#a77;,b7 ( ! ,social ,security ,act2 & 7,,viii7 id5tify claims = cov]$ outpati5t drugs subject to an agreem5t "u ?is section t are submitt$ by ph>macies remov$ f ! #cdj;,b program pursuant to subsection 7a77#e77;,f77ix77,,iii7 & notify ! ,secret>y ( ! submission ( any su* claims by any su* ph>macies4 7iv7 ,resolution ( violations 7,i7 ,m$icaid duplicate disc\nts ,! ,secret>y1 9 consultation ) ! ,/ate1 z appropriate1 %all take prompt action to fairly & adequately resolve violations describ$ 9 clause 7i77,i7 report$ by ! cle>+h\se 9 accordance ) clause 7iii77,,iii74 7,,ii7 ,nonduplication ) maximum fair price ,! ,secret>y %all take prompt action to fairly & adequately resolve violations describ$ 9 clause 7i77,,ii7 report$ by ! cle>+h\se 9 accordance ) clause 7iii77,,iv74 7,,iii7 ,duplicate cov]$ entity disc\nts ,! ,secret>y %all develop & implem5t a process to resolve duplicate claims = a rebate or disc\nt "u ?is section describ$ 9 clause 7i77,,iv7 su* t ! manufactur] pays only "o rebate or disc\nt "u ?is section ) respect to ! same unit ( a cov]$ outpati5t drug pur*as$ "u ! program "u ?is section4 ,cov]$ entities 7& any entities act+ on _! behalf7 %all be subject to det]m9ations made by ! ,secret>y to resolve su* duplicate claims 7& ! ,secret>y may contract ?is function to ! cle>+h\se to make su* det]m9ations74 ,9 mak+ su* det]m9ations1 ! ,secret>y %all inve/igate duplicate claims = rebates or disc\nts & require cov]$ entities 7& any entities act+ on _! behalf7 to take action to avoid or pay refunds to rev]se a duplicate claim4 7,,iv7 ,refunds to manufactur]s ,! ,secret>y %all be responsible = promptly refund+ affect$ manufactur]s ( cov]$ outpati5t drugs = violations describ$ 9 subclauses 7,i7 & 7,,ii7 ( clause 7i7 & seek+ subsequ5t repaym5t f cov]$ entities or ,/ates 7) respect to violations describ$ 9 clause 7i77,i771 or provid]s or disp5s]s 7) respect to violations describ$ 9 clause 7i77,,ii774 ,subject to ! det]m9ation by ! ,secret>y or cle>+h\se "u subclause 7,,iii71 ! cov]$ entity 7or entities7 %all be liable to ! manufactur] ( ! cov]$ outpati5t drug t is ! subject ( ! violation describ$ 9 clause 7i77,,iv7 9 an am\nt equal to ! r$uction 9 ! price ( ! drug 7z describ$ 9 subsection 7a77#a77 & %all repay su* am\nt to su* manufactur] )9 #fj days ( receiv+ a notice describ$ 9 clause 7iii77,,iv74 4 7b7 ,provision ( drug claims data by m$icaid2 removal ( duplicate claims 7#a7 ,m$icaid ,section #aijb7;a7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77 is am5d$-- 7,a7 9 p>agraph 7#hf71 by /rik+ & at ! end2 7,b7 9 p>agraph 7#hg77;,d71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,c7 by ins]t+ aft] p>agraph 7#hg7 ! foll[+ new p>agraph3 7#hh7 provide = a me*anism = ! ,/ate ag5cy to furni%1 & = ! ,/ate ag5cy to require ea* ,m$icaid manag$ c>e organization 7z def9$ 9 section #aijc7m77#a77;,a77 to furni%1 to ! cle>+h\se1 9 a ma*9e-readable =mat1 )9 #e days foll[+ ! date ( claim paym5t1 claims level data1 includ+ rebate file data1 = cov]$ outpati5t drugs disp5s$1 furni%$1 or adm9i/]$ to individuals enroll$ "u a ,/ate plan 7or a waiv] ( su* plan7 t includes1 ) respect to ea* disp5se1 furni%+1 or adm9i/ration ( su* a drug1 ! data elem5ts describ$ 9 subsection #cdj;,b7a77#e77;,j77iii7 ( ! ,public ,heal? ,s]vice ,act1 & = ! ,/ate ag5cy to remove f any rebate reque/ describ$ 9 section #cdj;,b7d77#b77;,c77i77,i7 ( su* ,act any claim t is ! subject ( a notice submitt$ by su* entity "u section #cdj;,b7d77#b77;,c77iii77,,iii7 ( su* ,act4 4 7c7 ,provision ( drug claims data by ,m$ic>e 7#a7 ,m$ic>e ,"p ,b ,section #ahdb ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acieu7 is am5d$ by add+ at ! end ! foll[+3 7v7 ,provision ( drug claims data2 me*anism ,to refund duplicat$ am\nts ,ea* ,m$ic>e adm9i/rative contractor %all furni% to ! cle>+h\se1 9 a ma*9e-readable =mat1 claims level data = cov]$ outpati5t drugs furni%$ or adm9i/]$ to individuals enroll$ "u ?is "p t includes1 ) respect to ea* furni%+ or adm9i/ration ( su* a drug1 ! data elem5ts describ$ 9 section #cdj;,b7a77#e77;,j77iii7 ( ! ,public ,heal? ,s]vice ,act4 ,ea* ,m$ic>e adm9i/rative contractor %all furni% su* data to ! cle>+h\se )9 #e days foll[+ ! date ! claim = su* drug is paid by ! ,m$ic>e adm9i/rative contractor4 4 7#b7 ,m$ic>e ,advantage organizations ,section #aheg7;e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;e77 is am5d$ by add+ at ! end ! foll[+3 7#f7 ,provision ( drug claims data2 me*anism to refund duplicat$ am\nts ,a contract "u ?is "p %all require a ,m$ic>e,*oice organization to furni% to ! cle>+h\se1 9 a ma*9e-readable =mat1 claims level data = cov]$ outpati5t drugs furni%$ or adm9i/]$ to individuals enroll$ ) ! organization "u ?is "p t includes1 ) respect to ea* furni%+ or adm9i/ration ( su* a drug1 ! data elem5ts describ$ 9 section #cdj;,b7a77#e77;,j77iii7 ( ! ,public ,heal? ,s]vice ,act4 ,su* contract %all require ! ,m$ic>e,*oice organization to furni% su* data to ! cle>+h\se )9 #e days foll[+ ! date ! claim = su* drug is paid by ! ,m$ic>e,*oice organization4 4 7#c7 ,prescription drug plans ,section #ahfj;,d-#ab7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77 is am5d$ by add+ at ! end ! foll[+3 7#i7 ,provision ( drug claims data2 me*anism to refund duplicat$ am\nts ,a contract "u ?is "p %all require a ,,pdp sponsor to furni% to ! cle>+h\se 9 a ma*9e-readable =mat1 claims level data = cov]$ outpati5t drugs disp5s$ to individuals enroll$ 9 a prescription drug plan (f]$ by su* sponsor "u ?is "p t includes1 ) respect to ea* disp5se ( su* drug1 ! data elem5ts describ$ 9 section #cdj;,b7a77#e77;,j77iii7 ( ! ,public ,heal? ,s]vice ,act4 ,su* contract %all require a ,,pdp sponsor to furni% su* data to ! cle>+h\se )9 #e days foll[+ ! date ! claim = su* drug is paid by ! ,,pdp sponsor4 4 7#d7 ,,ma-,p,ds ,section #aheg7;f77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;f77#c77 is am5d$ by add+ at ! end ! foll[+3 7,f7 ,provision ( drug claims data2 me*anism to refund duplicat$ am\nts ,section #ahfj;,d-#ab7;b77#i74 4 #ag4 ,limitation on adm9i/rator s]vice fees & contract ph>macy fees ,section #cdj;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7 is am5d$ by add+ at ! end ! foll[+3 7f7 ,requirem5ts = ,,tpa & contract ph>macy remun]ation 7#a7 ,?ird-p>ty adm9i/rator fees ,a ?ird-p>ty adm9i/rator furni%+ #cdj;,b program-relat$ s]vices on behalf ( a cov]$ entity describ$ 9 subsection 7a77#d71 includ+ review+ or process+ claims or o!r in=mation to id5tify cov]$ outpati5t drugs disp5s$ to individuals :o are pati5ts ( ! cov]$ entity 7z def9$ 9 subsection 7b77#c77 may receive remun]ation f su* cov]$ entity = ! p]=mance ( su* s]vices only if-- 7,a7 su* remun]ation is a flat doll> am\nt n directly or indirectly bas$ on any price (1 or disc\nt or o!r remun]ation provid$ ) respect to1 a cov]$ outpati5t drug1 paid = ea* unit ( s]vice furni%$ to ! cov]$ entity1 reg>dless ( :e!r a prescription 0 disp5s$ to an individual :o is a pati5t ( ! cov]$ entity2 7,b7 ! am\nt ( su* remun]ation is consi/5t ) fair m>ket value 9 an arm's-l5g? transaction = ! bona fide1 itemiz$ #cdj;,b-relat$ s]vices actually p]=m$ on behalf ( ! cov]$ entity2 & 7,c7 su* remun]ation complies ) applicable ,/ate & ,f$]al law1 includ+ section #aabh;,b7b7 ( ! ,social ,security ,act4 7#b7 ,contract ph>macy fees ,a contract ph>macy t has ent]$ into a writt5 agreem5t ) a cov]$ entity pursuant to & satisfies ! applicable requirem5ts 9 subsection 7a77#e77;,f7 may receive remun]ation f su* cov]$ entity = ! p]=mance ( s]vices associat$ ) disp5s+ cov]$ outpati5t drugs subject to an agreem5t "u ?is section to individuals :o are pati5ts ( ! cov]$ entity 7z def9$ 9 subsection 7b77#c77 only if-- 7,a7 su* remun]ation is a flat doll> am\nt n directly or indirectly bas$ on any price (1 or disc\nt or o!r remun]ation provid$ ) respect to1 a cov]$ outpati5t drug1 paid = ea* disp5se ( su* a drug to a pati5t ( ! cov]$ entity2 7,b7 ! am\nt ( remun]ation = ea* disp5se does n exce$ #abe p]c5t ( ! av]age p]-prescription disp5s+ fee paid to su* ph>macy by all ?ird-p>ty payors1 bas$ on data f ! mo/ rec5t full cal5d> ye> = :i* su* data is available2 7,c7 ! am\nt ( su* remun]ation is consi/5t ) fair m>ket value 9 an arm's-l5g? transaction = ! bona fide1 itemiz$ #cdj;,b-relat$ s]vices actually p]=m$ on behalf ( ! cov]$ entity2 & 7,d7 su* remun]ation complies ) applicable ,/ate & ,f$]al law1 includ+ section #aabh;,b7b7 ( ! ,social ,security ,act4 ,= purposes ( subp>agraph 7,b71 if a cov]$ entity has ent]$ into an agreem5t = contract ph>macy s]vices pursuant to subsection 7a77#e77;,f7 t p]mits ! contract ph>macy s]vice provid] to disp5se cov]$ outpati5t drugs on behalf ( ! cov]$ entity at m ?an "o ph>macy location1 ! av]age disp5s+ fee %all be calculat$ across all ph>macy locations subject to su* agreem5t4 7#c7 ,auditable records ,a cov]$ entity %all reta9 copies ( writt5 agreem5ts ) ?ird-p>ty adm9i/rators or contract ph>macies describ$ 9 ?is subsection = a p]iod ( "t specifi$ by ! ,secret>y & %all make copies ( su* agreem5ts available to ! ,secret>y or _! designee ^u reque/4 7#d7 ,civil monet>y p5alty ,a ?ird-p>ty adm9i/rator or contract ph>macy describ$ 9 ?is subsection t fails to comply ) ! applicable requirem5ts specifi$ 9 ?is subsection %all be requir$ to pay a civil monet>y p5alty equal to #aj times ! am\nt su* ?ird-p>ty adm9i/rator or contract ph>macy receiv$ = ! p]=mance ( relevant s]vices describ$ 9 ?is subsection4 ,! provisions ( section #aabh;,a ( ! ,social ,security ,act 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil monet>y p5alty "u ?is p>agraph 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 ,! ,(fice ( ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all c>ry out ! provisions relat$ to ! imposition ( civil monet>y p5alties "u ?is p>agraph4 4 #ah4 ,cl>ification ,section #cdj;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7 is fur!r am5d$ by add+ at ! end ! foll[+3 7g7 ,cl>ification ,! provisions ( ?is section sup]s$e any provision or requirem5t ( ,/ate or local law ins(> z t ,/ate or local law may e/abli%1 implem5t1 or cont9ue 9 effect a /&>d or requirem5t t diff]s f or relates 9 any way to ! provisions ( ?is section or1 except = any ,/ate regulations issu$ to c>ry out subsection 7a77#e77;,a77iii71 relates 9 any way to ! drug disc\nt program "u ?is section or cov]$ outpati5t drugs subject to an agreem5t "u ?is section1 includ+ ! di/ribution ( su* drugs4 ,except = any ,/ate regulations issu$ to c>ry out subsection 7a77#e77;,a77iii71 no provision or requirem5t ( ,/ate or local law %all grant additional rights or impose additional obligations relat$ to ! #cdj;,b program4 4 #ai4 ,ensur+ ! equitable treatm5t ( #cdj;,b cov]$ entities & ph>macies p>ticipat+ 9 ! #cdj;,b drug disc\nt program 7a7 ,gr\p heal? plan & heal? insurance issu] requirem5ts ,subp>t ,,ii ( "p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq47 is am5d$ by add+ at ! end ! foll[+3 #bgcj4 ,requirem5ts relat+ to ! #cdj;,b drug disc\nt program 7a7 ,9 g5]al ,a gr\p heal? plan1 a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age1 or a ph>macy b5efit manag] act+ on behalf ( su* plan or issu]1 may n discrim9ate aga9/ a cov]$ entity 7z def9$ 9 subsection 7e77#a771 a contract ph>macy 7z def9$ 9 subsection 7e77#b771 or a p>ticipant1 b5efici>y1 or enrollee ( su* plan or cov]age by impos+ requirem5ts1 exclusions1 reimbursem5t t]ms1 or o!r conditions on su* entity or ph>macy t diff] f ^? appli$ to entities or ph>macies t are n cov]$ entities or contract ph>macies on ! basis t ! entity or ph>macy is a cov]$ entity or contract ph>macy or t ! entity or ph>macy disp5ses #cdj;,b drugs1 by tak+ any action prohibit$ "u subsection 7b74 7b7 ,specifi$ prohibit$ actions ,a gr\p heal? plan1 a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age1 or a ph>macy b5efit manag] act+ on behalf ( su* plan or issu]1 may n discrim9ate aga9/ a cov]$ entity1 a contract ph>macy1 or a p>ticipant1 b5efici>y1 or enrollee ( su* plan or cov]age by do+ any ( ! foll[+3 7#a7 ,reimburs+ a cov]$ entity or contract ph>macy = a quantity ( a #cdj;,b drug 7z def9$ 9 subsection 7e77 9 an am\nt less ?an su* plan1 issu]1 or ph>macy b5efit manag] 7z applicable7 w\ld pay to any o!r simil>ly situat$ 7z specifi$ by ! ,secret>y7 entity or ph>macy t is n a cov]$ entity or a contract ph>macy = su* quantity ( su* drug on ! basis t ! entity or ph>macy is a cov]$ entity or contract ph>macy or t ! entity or ph>macy disp5ses #cdj;,b drugs4 7#b7 ,impos+ any t]ms or conditions on cov]$ entities or contract ph>macies ) respect to any ( ! foll[+ t diff] f su* t]ms or conditions appli$ to o!r simil>ly situat$ entities or ph>macies t are n cov]$ entities or contract ph>macies on ! basis t ! entity or ph>macy is a cov]$ entity or contract ph>macy or t ! entity or ph>macy disp5ses #cdj;,b drugs3 7,a7 ,fees1 *>gebacks1 clawbacks1 adju/m5ts1 or o!r assessm5ts4 7,b7 ,pr(essional disp5s+ fees4 7,c7 ,re/rictions or requirem5ts reg>d+ p>ticipation 9 /&>d or pref]r$ ph>macy networks4 7,d7 ,requirem5ts relat+ to ! frequ5cy or scope ( audits or to inv5tory managem5t sy/ems us+ g5]ally accept$ acc\nt+ pr9ciples4 7,e7 ,any o!r re/rictions1 conditions1 practices1 or policies t int]f]e ) ! ability ( a cov]$ entity or contract ph>macy to use ! disc\nts provid$ "u section #cdj;,b 9 accordance ) applicable requirem5ts "u su* section4 7#c7 ,int]f]+ ) an individual's *oice to receive a #cdj;,b drug f a cov]$ entity or contract ph>macy1 :e!r 9 p]son or via direct deliv]y1 mail1 or o!r =m ( %ipm5t1 z p]mitt$ "u section #cdj;,b4 7#d7 ,int]f]+ )1 limit+1 or prohibit+ actions by a cov]$ entity or contract ph>macy to id5tify1 ei!r directly or ?r\gh a ?ird p>ty1 claims = #cdj;,b drugs1 includ+ by submission ( claims data or use ( claims modifi]s or indicators4 7#e7 ,refus+ to contract ) a cov]$ entity or contract ph>macy = reasons o!r ?an ^? t apply equally to entities or ph>macies t are n cov]$ entities or contract ph>macies1 or on ! basis t-- 7,a7 ! entity or ph>macy is a cov]$ entity or a contract ph>macy2 or 7,b7 ! entity or ph>macy is describ$ 9 any ( subp>agraphs 7,a7 ?r\gh 7,o7 ( section #cdj;,b7a77#d74 7#f7 ,) respect to a gr\p heal? plan or heal? insurance issu] = heal? insurance cov]age1 d5y+ cov]age ( a drug on ! basis t su* drug is a #cdj;,b drug4 7c7 ,prohibit$ actions 9 d]ogation ( section #cdj;,b af=dability assi/ance provisions ,a gr\p heal? plan1 a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age1 or a ph>macy b5efit manag] act+ on behalf ( su* plan or issu] %all n prohibit or re/rict1 9 contracts ) ph>macies 9 _! network t are contract ph>macies or entity ph>macies1 or 9 any o!r mann]1 any r$uction 9 or subsidy = ! out-(-pocket am\nt = a #cdj;,b drug *>g$ to an individual 7includ+ a p>ticipant1 b5efici>y1 or enrollee ( su* plan or cov]age7 t is requir$ or au?oriz$ by subp>agraphs 7,g7 or 7,h7 ( section #cdj;,b7a77#e74 ,any g5]al prohibition or re/riction on r$uc+ or subsidiz+ ! out-(-pocket am\nt = a drug *>g$ to an individual t lacks an express exemption = any r$uctions 9 or subsidies = ! out-(-pocket am\nt = a #cdj;,b drug t are requir$ or au?oriz$ by subp>agraphs 7,g7 or 7,h7 ( section #cdj;,b7a77#e7 is a violation ( ?is subsection4 ,any contractual provision t violates ?is subsection 9 any mann] %all be void & un5=ceable4 7d7 ,en=cem5t me*anism = ph>macy b5efit manag]s ,! ,secret>y %all impose a civil monet>y p5alty on any ph>macy b5efit manag] t violates ! requirem5ts ( ?is section4 ,su* p5alty %all n exce$ #e1jjj p] violation p] day4 ,! ,secret>y %all issue propos$ regulations to implem5t ?is subsection n lat] ?an #fj days aft] ! date ( ! enactm5t ( ?is subsection & %all f9alize su* regulations n lat] ?an #ahj days aft] su* date ( enactm5t4 7e7 ,def9itions ,= purposes ( ?is section3 7#a7 #cdj;b drug ,! t]m #cdj;,b drug means a drug t is-- 7,a7 a cov]$ outpati5t drug 7z def9$ = purposes ( section #cdj;,b72 & 7,b7 pur*as$ "u an agreem5t 9 effect "u su* section4 7#b7 ,contract ph>macy ,! t]m contract ph>macy has ! mean+ giv5 su* t]m 9 section #cdj;,b7a77#e77;,f74 7#c7 ,cov]$ entity ,! t]m cov]$ entity has ! mean+ giv5 su* t]m 9 section #cdj;,b7a77#d74 7#d7 ,entity ph>macy ,! t]m entity ph>macy has ! mean+ giv5 su* t]m 9 section #cdj;,b7a77#e77;,f74 4 7b7 ,application ( requirem5ts to ,m$ic>e 7#a7 ,"p ,d ,section #ahfj;,d-#ab7;b7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77 is am5d$ by add+ at ! end ! foll[+3 7#aj7 ,application ( requirem5ts relat+ to ! #cdj;,b drug disc\nt program ,ea* contract ent]$ into "u ?is subsection ) a ,,pdp sponsor %all provide t ! requirem5ts ( section #bgcj ( ! ,public ,heal? ,s]vice ,act apply to su* sponsor1 & to any ph>macy b5efit manag] t contracts ) su* sponsor1 9 ! same mann] z su* requirem5ts apply ) respect to a gr\p heal? plan1 a heal? insurance issu]1 or a ph>macy b5efit manag] describ$ 9 su* section4 4 7#b7 ,"p ,c ,section #aheg7;f77#c7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;f77#c77 is am5d$ by add+ at ! end ! foll[+3 7,g7 #cdj;,b drug disc\nt program ,section #ahfj;,d-#ab7;b77#aj74 4 #bj4 ,effective date ,except z o!rwise specifi$1 ! provisions 9 ?is ,act %all become effective on ! date t is "o ye> foll[+ ! date ( enactm5t ( ?is ,act4