,i #aai? ,,congress #b;d ,session ,h4 ,r4 #ieii ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,july #f1 #bjbf,mr4 ,pet]s 7= himself1 ,mr4 ,joyce ( ,p5nsylvania1 ,mr4 ,au*9closs1 ,mr4 ,cr5%aw1 & ,ms4 ,b>ragn7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committees on ,ways & ,means1 & ,education & ,work=ce1 = 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 /r5g!n ! #cdj;,b drug disc\nt program4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,/r5g!n+ ! ,ex]cise ( ,controls & ,upgrad+ ,requirem5ts = ,effici5cy 9 #cdj;,b ,act or ! ,,secure #cdj;,b ,act4 7b7 ,table ( cont5ts ,! table ( cont5ts ( ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4 ,sec4 #b4 ,e/abli%+ a cle> pati5t def9ition4 ,sec4 #c4 ,all[able use & robu/ ov]sight ( contract ph>macies4 ,sec4 #d4 ,eligibility = *ild sites4 ,sec4 #e4 ,improv+ pati5t af=dability & protections4 ,sec4 #f4 ,data report+ = transp>5cy4 ,sec4 #g4 ,enhanc+ program integrity4 ,sec4 #h4 ,facilitat+ data ex*ange to improve program integrity4 ,sec4 #i4 ,prohibition on discrim9atory practices & contract+4 ,sec4 #aj4 ,ensur+ ,,hrsa has adequate res\rces to ov]see ! program4 ,sec4 #aa4 ,/udies & reports4 ,sec4 #ab4 ,mean+s4 ,sec4 #ac4 ,requirem5ts = nonhospital cov]$ entities & subgrantees4 ,sec4 #ad4 ,effective date4 #b4 ,e/abli%+ a cle> pati5t def9ition 7a7 ,9 g5]al ,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 ,pati5t def9$ 7,a7 ,9 g5]al ,9 ?is section1 ! t]m pati5t means an individual :o-- 7i7 has receiv$ an outpati5t heal? c>e s]vice f a prescrib+ provid] at a cov]$ entity )9 ! prec$+ #bd mon?s1 & su* heal? c>e s]vice-- 7,i7 is a s]vice t 0 reimbursable "u title ,,xviii ( ! ,social ,security ,act :5 furni%$ by a prescrib+ provid] or1 9 ! case ( an individual :o is n eligible = b5efits "u su* title1 w\ld h be5 s reimbursable _h ! individual be5 s eligible2 a s]vice %all be consid]$ reimbursable if x is ( a type eligible = reimbursem5t "u title ,,xviii2 & 7,,ii7 9 ! case ( a cov]$ entity describ$ 9 subp>agraphs 7,a7 ?r\gh 7,k7 ( subsection 7a77#d71 is a s]vice t is )9 ! scope ( ! grant or designation describ$ 9 su* subp>agraph4 7ii7 receiv$ ! prescription or ord] = ! cov]$ outpati5t drug relat$ to ! s]vice describ$ 9 clause 7i72 & 7iii7 has a relation%ip ) ! cov]$ entity su* t ! cov]$ entity creates & ma9ta9s auditable heal? c>e records :i* demon/rate t-- 7,i7 ! cov]$ entity ma9ta9s a provid]-to-pati5t relation%ip ) ! individual = ! heal?c>e s]vice relat$ to ! cov]$ outpati5t prescription or ord]2 7,,ii7 ! prescrib+ provid] has cl9ical responsibility & ov]sight = ! individual's heal? c>e s]vice relat$ to ! prescription or ord] = ! cov]$ outpati5t drug ) ! cov]$ entity2 & 7,,iii7 any o!r in=mation specifi$ by ! ,secret>y ?r\gh notice & comm5t rulemak+4 7,b7 ,application ,= ea* prescription or ord] = a cov]$ outpati5t drug1 an individual %all qualify z a pati5t "u subp>agraph 7,a7 only if ! requirem5ts ( su* subp>agraph are indep5d5tly satisfi$ ) respect to t prescription or ord]4 7,c7 ,record ret5tion & audit+ ,a cov]$ entity %all-- 7i7 reta9 auditable heal? c>e records 9 a =m & mann] specifi$ by ! ,secret>y ?r\gh notice & comm5t rulemak+ :i* demon/rate ! exi/5ce ( a pati5t relation%ip 9 accordance ) ?is p>agraph = ea* prescription or ord] = a cov]$ outpati5t drug = a p]iod ( ! great] ( #e ye>s or su* p]iod z requir$ "u applicable ,/ate & ,f$]al laws gov]n+ m$ical or ph>macy records2 & 7ii7 no m ?an "o "t annually1 9 accordance ) subsection 7a77#e77;,c71 p]mit ! ,secret>y & ! manufactur] ( a cov]$ outpati5t drug t is subject to an agreem5t "u ?is subsection1 to audit1 at ! ,secret>y's or ! manufactur]'s exp5se1 ! records ( ! entity :i* demon/rate ! exi/5ce ( a pati5t relation%ip 9 accordance ) ?is p>agraph & :i* directly p]ta9 to ! entity's compliance ) ! requirem5ts ( subsection 7a77#e77;,b74 4 7b7 ,additional am5dm5ts ,section #cdj;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7 is am5d$-- 7#a7 9 subsection 7a71 by add+ at ! end ! foll[+3 7#ab7 ,prescrib+ provid] ,9 ?is section1 ! t]m prescrib+ provid] means a heal? c>e provid] :o1 at ! "t ! heal? c>e provid] ord]s or prescribes a cov]$ outpati5t drug-- 7,a7 7i7 is an employee or indep5d5t contractor ( ! cov]$ entity su* t ! cov]$ entity bills = s]vices furni%$ by ! heal? c>e provid] & is responsible = ! c>e furni%$ by su* provid]2 or 7ii7 is an employee or indep5d5t contractor ( a physician organization affiliate ( ! cov]$ entity1 has assign$ _! "r to bill & collect = pr(essional s]vices to su* physician organization affiliate1 & furni%es outpati5t heal? c>e s]vices to pati5ts ( ! cov]$ entity4 7,b7 has cl9ical responsibility ov] ! c>e relat$ to ! ord] or prescription = ! cov]$ outpati5t drug1 z demon/rat$ by ! provid]'s signature on ! relevant ord] or prescription = ! cov]$ outpati5t drug2 7,c7 is enroll$ z a provid] 9 ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act1 or ! ,m$icaid program "u title ,,xix ( ! ,social ,security ,act2 & 7,d7 is n exclud$ by ! ,secret>y f p>ticipation 9 ,m$ic>e & ,/ate heal? c>e programs pursuant to section #aabh ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g74 2 & 7#b7 9 subsection 7b71 by add+ at ! end ! foll[+3 7#c7 ,physician organization affiliate def9$ ,= purposes ( subp>agraph 7,a77ii71 ! t]m physician organization affiliate means an entity t-- 7,a7 is lawfully organiz$ = ! purpose ( employ+ or contract+ ) lic5s$ pr(essionals to furni% cl9ical s]vices2 7,b7 has an ongo+1 legally b9d+ agreem5t ) ! cov]$ entity to provide heal? c>e s]vices to pati5ts ( ! cov]$ entity at ! cov]$ entity's locations2 & 7,c7 ! outpati5t heal?c>e s]vices are provid$ su* t responsibility = ! c>e provid$ rema9s ) ! cov]$ entity & meets ! o!r requirem5ts 9 ?is p>agraph4 4 7c7 ,ref]ral requirem5ts ,section #cdj;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b71 z am5d$1 is am5d$ by add+ at ! end ! foll[+ new subsection3 7f7 ,ref]ral qualifications 7#a7 ,9 g5]al ,subject to ! requirem5ts ( ?is subsection1 9 ! case ( a pati5t ( an eligible cov]$ entity :o is ref]r$ by su* cov]$ entity to a provid] outside su* cov]$ entity1 & su* non-cov]$ entity provid] prescribes a cov]$ outpati5t drug )9 #bd mon?s ( ! date ( su* ref]ral1 ! eligible cov]$ entity may provide su* drug to su* pati5t z a cov]$ outpati5t drug pursuant to ! drug disc\nt program "u ?is section1 9 ! same mann] & "u ! same conditions z ! cov]$ entity w\ld provide su* drug _h su* drug be5 prescrib$ by a prescrib+ provid] ( su* cov]$ entity4 7#b7 ,cov]$ entity eligibility ,= purposes ( ?is subsection ! cov]$ entity t disp5ses or adm9i/]s ! cov]$ outpati5t drug mu/ be-- 7,a7 a f$]ally qualifi$ heal? c5t]1 z describ$ 9 subsection 7a77#d77;,a71 t is also a compreh5sive prim>y c>e m$ical home1 c]tifi$ z a ,pati5t-,c5t]$ ,m$ical ,home by a national accr$it+ organization2 7,b7 a critical access hospital1 z describ$ 9 subsection 7a77#d77,n72 or 7,c7 a sole community hospital1 z describ$ 9 subsection 7a77#d77,o74 7#c7 ,pati5t eligibility ,= purposes ( ?is subsection-- 7,a7 ! individual to :om a cov]$ outpati5t drug is disp5s$ or adm9i/]$ mu/ be a pati5t ( ! cov]$ entity meet+ ! requirem5ts "u 7a77#aa72 7,b7 ! individual mu/ h receiv$ direct c>e f ! cov]$ entity )9 #bd mon?s prior to ! date on :i* ! individual 0 ref]r$ to receive c>e by ! prescrib+ entity2 7,c7 ! c>e furni%$ to ! individual by ! cov]$ entity t result$ 9 ! ref]ral mu/ be-- 7i7 9 ! case ( a f$]ally qualifi$ heal? c5t] describ$ 9 p>agraph 7#b77;,a71 )9 ! scope ( ! grant application made to ! ,secret>y "u section #ccj7k77#a72 7ii7 9 ! case ( a critical access hospital describ$ 9 p>agraph 7#b77;,b71 )9 ! scope ( ! agreem5t ) ! ,/ate "u section #ahbj7;c77#b7 ( ! ,social ,security ,act2 & 7iii7 9 ! case ( a sole community hospital describ$ 9 p>agraph 7#b77;,c71 )9 ! scope ( ! reque/ made to ! ,secret>y = su* classification "u section #ahhf7;d77#e77;,c77iii7 ( ! ,social ,security ,act2 7,d7 ! cov]$ entity mu/ h-- 7i7 ,ref]r$ ! individual to ! prescrib+ entity2 7ii7 ,consult$ ) a cl9ician at ! prescrib+ entity reg>d+ ! individual's c>e2 & 7iii7 ,provid$ c>e to ! individual aft] disp5s+ or adm9i/]+ ! prescription1 z appropriate2 & 7,e7 9 ! case ( a f$]ally qualifi$ heal? c5t] describ$ 9 p>agraph 7#b77;,a71 a prescription g5]at$ z a direct result ( an em]g5cy dep>tm5t visit or hospital dis*>ge4 7#d7 ,exclusions ,! foll[+ categories ( drugs %all n be eligible = disc\nts "u ?is subsection-- 7,a7 orphan-designat$ drugs2 or 7,b7 9 ! case ( a prescription writt5 by a f$]ally qualifi$ heal? c5t] describ$ 9 p>agraph 7#b77;,a71 a drug t is infus$ or t requires a cl9ician to adm9i/]1 except = ^? entities provid+ infusions z ( ! date ( enactm5t ( ?is ,act & subject to ! limitation describ$ 9 p>agraph 7#e74 7#e7 ,docum5tation requirem5ts 7,a7 ,9 g5]al ,9 association ) any cov]$ outpati5t drug receiv+ a disc\nt "u ?is subsection1 ! individual's m$ical record mu/ include docum5tation to demon/rate compliance ) ! requirem5ts ( p>agraph 7#c71 includ+-- 7i7 docum5tation ( ! direct c>e provid$ to ! individual by ! cov]$ entity prior to ! ref]ral to ! prescrib+ entity2 7ii7 docum5tation ( ! ref]ral f ! cov]$ entity to ! prescrib+ entity2 7iii7 docum5tation ( direct c>e receiv$ by ! individual f ! cov]$ entity t result$ 9 ! ref]ral & t occurr$ )9 #bd mon?s prior to ! initial ref]ral2 7iv7 docum5tation ( c>e receiv$ by ! individual f ! prescrib+ entity )9 #bd mon?s ( ! cov]$ entity ref]ral1 :i* may take ! =m ( receipt ( consult notes or docum5tation ( a discussion betwe5 ! cov]$ entity & prescrib+ entity reg>d+ ! c>e furni%$ by ! prescrib+ entity2 7v7 docum5tation ( ongo+ consultation betwe5 ! cov]$ entity & ! prescrib+ entity z appropriate = ! cov]$ entity's ongo+ responsibility ( ! individual's c>e1 consi/5t ) ! scope ( c>e describ$ 9 p>agraph 7#c77;,c72 & 7vi7 docum5tation ( ! prescrib+ entity's prescription to be disp5s$ or adm9i/]$ by ! cov]$ entity & updat$ ?r\gh ! qualifi$ entity's m$ication li/ = ! pati5t4 7,b7 ,docum5t ret5tion ,all docum5tation describ$ "u ?is p>agraph %all be ma9ta9$ = a p]iod ( ! great] ( #e ye>s or su* p]iod z requir$ "u applicable ,/ate & ,f$]al laws gov]n+ m$ical or ph>macy records z auditable records t demon/rate compliance ) ! requirem5ts ( ?is subsection4 7#f7 ,ref]ral audits bas$ on volume 7,a7 ,9 g5]al ,! ,secret>y %all conduct audits ( any eligible cov]$ entity t meets ! foll[+ conditions 9 a giv5 ye>-- 7i7 ref]ral prescriptions describ$ 9 p>agraph 7#a7 exce$ #be p]c5t ( ! total numb] ( cov]$ outpati5t drugs pur*as$ & disp5s$ by ! cov]$ entity = ! ye>2 7ii7 ref]ral prescriptions describ$ 9 p>agraph 7#a7 are 9 ! #ge? p]c5tile ( all report+ cov]$ entities by cov]$ entity classification2 or 7iii7 ref]ral prescriptions exce$+ ! av]age annual p]c5tage = t cov]$ entity classification ov] ! mo/ rec5t #c-ye> p]iod1 ( ! total numb] ( cov]$ outpati5t drugs pur*as$ & disp5s$ by ! qualifi$ ref]ral cov]$ entity4 7,b7 ,transp>5cy ( in=mation ,! ,secret>y %all make public aggregate in=mation on eligible cov]$ entities audit$ "u subp>agraph 7,a7 available on a website ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration1 9 su* =m & mann] t ! ,secret>y det]m9es appropriate4 7#g7 ,additional audits 7,a7 ,9 addition to audits conduct$ "u p>agraph 7#f71 ! ,secret>y %all audit any cov]$ entity receiv+ disc\nts "u ?is subsection = compliance ) requirem5ts ( ?is subsection e f\r ye>s &1 9 ! case ( cov]$ entities receiv+ abnormal volumes ( disc\nts z comp>$ to su* cov]$ entity's disc\nts ov] ! previ\s ?ree ye> p]iod1 m frequ5tly 7b no m ?an "o "t annually74 7,b7 ,! ,secret>y %all ?r\gh notice & comm5t rulemak+ e/abli% a process = manufactur]s to reque/ audits ( disc\nts provid$ "u ?is subsection at any "t ! manufactur] provides docum5tation to ! ,secret>y ( suspect$ non-compliance ) ! requirem5ts ( ?is subsection1 ) in=mation receiv$ by ! manufactur] f ! cle>+h\se e/abli%$ "u section #aaej;,d ( ! ,social ,security ,act t provides cr$ible evid5ce ( non-compliance s]v+ z acceptable docum5tation = ?is purpose4 7#h7 ,en=cem5t 7,a7 ,loss ( ref]ral au?orization 7i7 ,a cov]$ entity = :i* ! ,secret>y det]m9es ?r\gh an audit conduct$ pursuant to or o!rwise au?oriz$ "u ?is section t ! %>e ( ref]ral prescriptions dur+ ! previ\s cal5d> ye> exce$s #ce p]c5t ( ! cov]$ entity's total numb] ( cov]$ outpati5t drugs pur*as$ & disp5s$ by ! cov]$ entity 9 ! applicable ye>1 may be subject to a ,corrective ,action ,plan 9 accordance ) ! corrective action plan process e/abli%$ "u subsection 7d77#b77;,b77vii74 7ii7 ,a cov]$ entity t fails to implem5t a ,corrective ,action ,plan requir$ "u clause 7i7 & comply ) ! timel9e = correction set =? 9 su* ,corrective ,action ,plan %all imm$iately lose eligibility "u ?is subsection = a p]iod det]m9$ by ! ,secret>y ?r\gh notice & comm5t rulemak+1 b no m ?an #a ye>4 7iii7 ,! ,secret>y & ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration %all develop a process ?r\gh notice & comm5t rulemak+ = cov]$ entities t lose eligibility = disc\nts "u ?is section pursuant to clause 7ii7 to complete ! ,corrective ,action ,plan & resume ref]rals "u ! program4 7,b7 ,monet>y p5alties ,! ,secret>y may impose civil monet>y p5alties on cov]$ entities = any disc\nts "u ?is section lat] deem$ ineligible on ! gr\nds ! cov]$ entity is f\nd to be noncompliant ) ! requirem5ts ( ?is subsection ) respect to ! relevant prescription4 ,! am\nt ( su* civil monet>y p5alties %all be paid to ! affect$ manufactur]4 4 #c4 ,all[able use & robu/ ov]sight ( contract ph>macies 7a7 ,use ( contract ph>macies ,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#ac7 ,contract ph>macies 7,a7 ,9 g5]al ,9 ! case ( a cov]$ entity t elects to contract ) a ph>macy or ph>macies to disp5se cov]$ outpati5t drugs pur*as$ by a cov]$ entity at or bel[ ! applicable ceil+ price describ$ 9 p>agraph 7#a7 to pati5ts ( ! cov]$ entity1 a manufactur] ( a cov]$ outpati5t drug t is subject to an agreem5t ) ! ,secret>y "u p>agraph 7#a7 %all-- 7i7 (f] ea* cov]$ entity cov]$ outpati5t drugs = pur*ase at or bel[ ! applicable ceil+ price describ$ 9 p>agraph 7#a7 reg>dless ( :e!r ! drug is disp5s$ directly by ! cov]$ entity or via a contract ph>macy arrangem5t2 7ii7 deliv] or all[ ! deliv]y ( cov]$ outpati5t drugs pur*as$ by cov]$ entity sites to ph>macy locations z reque/$ by a cov]$ entity1 9 accordance ) ! cov]$ entity's contract ph>macy agreem5ts2 7iii7 n place any ( ! foll[+ conditions on ! ability ( a cov]$ entity to pur*ase a cov]$ outpati5t drug at or bel[ ! applicable ceil+ price describ$ 9 p>agraph 7#a7 = disp5s+ accord+ to its writt5 contract ph>macy arrangem5ts3 7,i7 ,re/rict+ di/ribution options only ) respect to cov]$ outpati5t drugs1 cov]$ entities1 or contract ph>macies4 7,,ii7 ,requir+ ! submission ( claims data directly to ! manufactur] out ( submissions to ! entity receiv+ ! contract to ma9ta9 ! cle>+h\se "u section #aaej;,d ( ! ,social ,security ,act4 7,,iii7 ,condition+1 re/rict+1 or refus+ p>ticipation 9 su* an arrangem5t solely on ! basis t ! cov]$ entity elect$ to use a contract ph>macy4 7,,iv7 ,any su* o!r conditions specifi$ by ! ,secret>y ?r\gh notice & comm5t rulemak+4 7,b7 ,regi/ration ( contract ,ea* cov]$ entity %all regi/] ) ! ,secret>y any contract describ$ 9 subp>agraph 7,a71 9 accordance ) su* regi/ration requirem5ts e/abli%$ by ! ,secret>y ?r\gh notice & comm5t rulemak+4 ,su* regi/ration requirem5ts %all include requir+ cov]$ entities to-- 7i7 submit all contract ph>macy agreem5ts to ! ,secret>y 9 a timely mann]2 7ii7 regi/] ea* contract ph>macy arrangem5t ) ! ,secret>y1 z applicable1 prior to implem5t+ ! contract ph>macy agreem5t2 & 7iii7 atte/ to _! compliance ) ! requirem5ts "u ?is subsection at ! "t ( contract ph>macy regi/ration & annually !reaft]4 7,c7 ,contract review process ,! ,secret>y %all e/abli% ?r\gh notice & comm5t rulemak+ a process to review all writt5 agreem5ts betwe5 a cov]$ entity & ea* ( its contract ph>macies1 z describ$ 9 subp>agraph 7,a71 to ensure compliance ) ! requirem5ts "u ?is subsection4 ,9 connection ) su* review process1 !re %all be no limitation on ! numb] ( contract ph>macies a cov]$ entity may contract ) nor any geographic limitation on ! location ( su* contract ph>macies4 7,d7 ,transp>5cy ,! ,secret>y %all make ! foll[+ in=mation ab\t contract ph>macy arrangem5ts t h be5 approv$ "u subp>agraphs 7,a7 & 7,b7 available on ! public int]net website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices3 7i7 ,"n7s7 ( ea* cov]$ entity1 includ+ ! "n ( its *ild site7s7 t uses contract ph>macy7ies74 7ii7 ,"n7s7 & address7es7 ( ea* contract ph>macy location to :i* ! contract ph>macy arrangem5t applies4 7iii7 ,effective date7s7 ( ! contract ph>macy arrangem5t7s74 7iv7 ,! la/ ye> a drug 0 disp5s$ "u ! contract ph>macy arrangem5t7s7 f ea* location4 7v7 ,! volume ( disp5s$ drugs "u ?is section p] report+ p]iod4 7vi7 ,! geographic di/ance betwe5 ! cov]$ entity report$ "u 7i7 & ea* contract ph>macy report$ "u 7ii74 7vii7 ,in=mation on ! contract ph>macy's /atus z a mail-ord] or specialty ph>macy4 7viii7 ,details on ! location ( ! contract ph>macy1 includ+ :e!r ! contract ph>macy is locat$ 9-- 7,i7 an urban area 7"u ,c5sus def9ition72 7,,ii7 a rural area 7"u ,c5sus def9ition72 7,,iii7 a fronti] c\nty or fronti] ,/ate 7z def9$ 9 ,section #ahhf7;d77#c77;,e77iii77,,ii7 ( ! ,social ,security ,act72 7,,iv7 a m$ically und]s]v$ area 7,,mua7 z def9$ 9 section #biep7#f72 7,v7 a ,heal?c>e ,provid] ,%ortage ,area 7,,hpsa7 z def9$ 9 section #bed;e2 or 7,,vi7 an area classifi$ z "o = a m$ically und]s]v$ population 7,,mup7 z def9$ 9 section #bed;b7b77#c74 7,e7 ,improvem5ts 9 contract ph>macy arrangem5t integrity ,to ensure ! integrity ( contract ph>macy arrangem5ts describ$ 9 subp>agraph 7,a71 includ+ to prev5t div]sion & duplicate disc\nts describ$ 9 p>agraph 7#e77;,a71 ! ,secret>y %all promulgate rules to c>ry out ! foll[+3 7i7 ,require a writt5 agreem5t betwe5 a cov]$ entity & any ph>macy ) :i* ! cov]$ entity has a contract ph>macy arrangem5t4 ,ea* su* agreem5t %all-- 7,i7 li/ ! address ( ea* contract ph>macy location t w disp5se drugs on behalf ( ! cov]$ entity1 includ+ all cov]$ entity sites t plan to use ! contract ph>macy2 7,,ii7 be sign$ & 9 effect n lat] ?an ! day be=e ! contract ph>macy beg9s disp5s+ cov]$ outpati5t drugs pur*as$ "u ?is section on behalf ( ! cov]$ entity2 & 7,,iii7 include ! /&>d contract provisions e/abli%$ "u clause 7ii74 7ii7 ,develop /&>d contract provisions t are requir$ to be includ$ 9 ea* writt5 agreem5t describ$ 9 clause 7i71 includ+ provisions provid+ t-- 7,i7 ! cov]$ entity w pur*ase ! drug & ma9ta9 title to ! drug pursuant to ! t]ms ( ! aw>d or designation f ! ,dep>tm5t ( ,heal? & ,human ,s]vices t qualifies su* entity z a cov]$ entity & any applicable ,f$]al1 ,/ate1 or local law2 7,,ii7 ! contract ph>macy is responsible = provid+ ph>macy s]vices & provid+ data to cov]$ entities to support _! submission ( cov]$ outpati5t drug data to a cle>+h\se contract$ entity describ$ 9 section #aaej;,d ( ! ,social ,security ,act2 7,,iii7 ! cov]$ entity w n int]f]e ) pati5t *oice ( _! ph>macy provid] nor require pati5ts to use a c]ta9 ph>macy1 includ+ to obta9 a prescription f ! cov]$ entity & obta9 ! drug f ! ph>macy provid] ( 8 or h] *oice2 7,,iv7 ! contract ph>macy may provide o!r s]vices to ! cov]$ entity or its pati5ts at ! option ( ! cov]$ entity1 su* z home c>e1 deliv]y1 & reimbursem5t s]vices2 7,v7 reg>dless ( ! s]vices provid$ by ! contract ph>macy1 access to cov]$ outpati5t drugs pur*as$ "u ?is section w be re/rict$ to pati5ts ( ! cov]$ entity2 7,,vi7 ! cov]$ entity & ! contract ph>macy w adh]e to all ,f$]al1 ,/ate1 & local laws & requirem5ts2 7,,vii7 ! contract ph>macy w provide ! cov]$ entity ) any in=mation reque/$ consi/5t ) cu/om>y bus9ess practices1 su* z qu>t]ly bill+ /atem5ts1 /atus reports ( collections1 receiv+ & disp5s+ records1 & in=mation requir$ = audits "u subsection 7a77#e77;,c72 7,,viii7 ! cov]$ entity & ! contract ph>macy w utilize ! cle>+h\se to v]ify pati5t eligibility1 z def9$ by ! ,secret>y1 & w e/abli% & ma9ta9 safegu>ds to prev5t div]sion ( cov]$ outpati5t drugs pur*as$ "u ?is section2 7,,ix7 ! contract ph>macy may n use cov]$ outpati5t drugs pur*as$ "u ?is section to disp5se prescriptions t are reimburs$ "u ! ,m$icaid program "u title ,,xix ( ! ,social ,security ,act1 unless ! cov]$ entity1 ! contract ph>macy1 & ! ,/ate ,m$icaid ag5cy h e/abli%$1 9 writ+ & made available to ph>maceutical manufactur]s ^u reque/1 an arrangem5t to prev5t duplicate disc\nts1 consi/5t ) p>agraph 7#e77;,a72 7,x7 bo? ! cov]$ entity & ! contract ph>macy %all be subject to audits1 by ! ,secret>y & drug manufactur]s1 ( records t p]ta9 to ! cov]$ entity's compliance ) p>agraph 7#e71 to prev5t div]sion & violations ( ! duplicate disc\nt prohibition2 & 7,,xi7 ! contract ph>macy is requir$ to submit to ! cov]$ entity all data elem5ts ! cov]$ entity is requir$ to report to ! cle>+h\se pursuant to section #aaej;,d ( ! ,social ,security ,act4 7iii7 ,review writt5 agreem5ts1 at ! "t ( regi/ration or rec]tification1 or m frequ5tly if ! ,secret>y det]m9es necess>y1 betwe5 cov]$ entities & contract ph>macies to ensure compliance ) ! requirem5ts "u ?is section1 to analyze program op]ations1 & to provide program ov]sight4 7iv7 ,provide specific guidance to cov]$ entities reg>d+ ! ne$$ practices & proc$ures = contract ph>macy ov]sight1 includ+ ! scope & frequ5cy ( su* ov]sight4 7v7 ,e/abli% a ret5tion p]iod ( ! great] ( #e ye>s or su* p]iod z requir$ "u applicable ,/ate & ,f$]al laws gov]n+ m$ical or ph>macy records dur+ :i* cov]$ entities & contract ph>macies are requir$ to ma9ta9 all relevant auditable records 9 relation to contract ph>macy arrangem5ts1 includ+ records relat+ to transactions ( drugs pur*as$ pursuant to an agreem5t "u p>agraph 7#a71 suffici5t to demon/rate compliance ) ! requirem5ts to prev5t div]sion & violations ( ! duplicate disc\nt prohibition4 4 7b7 ,program integrity ,section #cdj;,b7d77#a77;,b77vi77,,iii7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7d77#a77;,b77vi77,,iii77 is am5d$-- 7#a7 by /rik+ int5tionally *>ges a & ins]t+ ! foll[+3 int5tionally-- 7aa7 *>ges a cov]$ entity a price = pur*ase ( a cov]$ outpati5t drug t exce$s ! maximum applicable price "u subsection 7a77#a72 2 7#b7 by /rik+ ! p]iod & ins]t+ a semicolon2 & 7#c7 by add+ at ! end ! foll[+3 7bb7 refuses to (f] a cov]$ outpati5t drug = pur*ase at or bel[ ! maximum applicable price "u subsection 7a77#a7 or deliv] or all[ to be deliv]$ a cov]$ outpati5t drug pur*as$ by a cov]$ entity at or bel[ su* maximum applicable price2 & 7cc7 places conditions on ! ability ( a cov]$ entity to pur*ase a cov]$ outpati5t drug at or bel[ ! maximum applicable price "u subsection 7a77#a74 4 #d4 ,eligibility = *ild sites ,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#ad7 ,*ild sites 7,a7 ,9 g5]al ,a cov]$ entity describ$ 9 subp>agraph 7,l71 7,m71 7,n71 or 7,o7 ( p>agraph 7#d7 t owns & op]ates a *ild site t p>ticipates 9 ! drug disc\nt program "u ?is section %all ma9ta9 docum5tation (1 & annually c]tify to ! ,secret>y ?r\gh su* c]tification processes e/abli%$ "u ! ,m$ic>e enrollm5t & co/ report+ rules1 t ea* su* *ild site is :olly own$ by ! entity & cl9ically & f9ancially integrat$ ) ! cov]$ entity & provid+ c>e consi/5t ) ! policies ( ! cov]$ entity1 includ+ by-- 7i7 regi/]+ ea* *ild site ) ! ,secret>y2 7ii7 apply+ ! same f9ancial assi/ance policy & pati5t assi/ance policy z apply ) respect to o!r sites op]at$ by ! cov]$ entity2 & 7iii7 ensur+ t ea* *ild site complies ) ! ,m$ic>e provid]-bas$ rules "u section #dac4fe ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulations7 or meets ! requirem5ts ( subp>agraph 7,b77i74 7,b7 ,eligibility = *ild sites 7i7 ,9 g5]al ,a *ild site is eligible = p>ticipation 9 ! drug disc\nt program "u ?is section1 ?r\gh ! eligibility ( ! cov]$ entity t owns & op]ates su* *ild site1 only if ! cov]$ entity demon/rates t ! *ild site meets ! foll[+ requirem5ts3 7,i7 ,! *ild site applies ! same pati5t f9ancial assi/ance policy z ! cov]$ entity4 7,,ii7 ,! *ild site p>ticipates z a provid] or suppli] 9 bo? ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act1 & ! ,m$icaid program "u title ,,xix ( su* ,act ( ! ,/ate 9 :i* ! *ild site is locat$1 )\t discrim9ation aga9/ pati5ts ( su* programs at su* locations4 7,,iii7 ,! *ild site ensures t ! provid]s :o ord] or disp5se cov]$ outpati5t drugs pur*as$ "u ?is section at ! *ild site h cl9ical responsibility = heal? c>e s]vices t are relat$ to ! use ( ! cov]$ outpati5t drug pur*as$ "u ?is section t is disp5s$4 7,,iv7 ,! *ild site provides a cl9ically mean+ful range ( s]vices )9 ! scope ( ! s]vices t prescrib+ provid]s employ$ by or contract$ ) ! *ild site1 cov]$ entity1 or a physician organization affiliate ( ! cov]$ entity are qualifi$ to deliv]4 7,v7 ,if ! *ild site is own$ by a cov]$ entity describ$ 9 p>agraph 7#d77,l71 ! *ild site %all ensure t ! provid] :o prescribes a cov]$ outpati5t drug pur*as$ "u ?is section meets ! requirem5ts 9 p>agraph 7#ab74 7,,vi7 ,! *ild site & ! cov]$ entity are op]at$ "u ! same lic5se1 except 9 areas :]e ! ,/ate requires a sep>ate lic5se = ! *ild site1 or 9 ,/ates :]e ,/ate law does n p]mit lic5sure ( ! *ild site & ! cov]$ entity "u a s+le lic5se4 ,if a ,/ate heal? facilities co/ review commission or o!r ag5cy t has au?ority to regulate ! rates *>g$ by provid]s 9 a ,/ate f9ds t a *ild site is n "p ( ! cov]$ entity1 ! *ild site %all n be eligible = ! drug disc\nt program "u ?is section4 7,,vii7 ,! cl9ical s]vices ( ! *ild site & ! cov]$ entity are integrat$ z evid5c$ by ! foll[+3 7aa7 ,pr(essional /aff ( ! *ild site h cl9ical privileges at ! cov]$ entity4 7bb7 ,! cov]$ entity ma9ta9s ! same monitor+ & ov]sight ( ! *ild site z = any o!r own$ entity or subsidi>y ( ! cov]$ entity4 7cc7 ,! m$ical director ( ! *ild site ma9ta9s a report+ relation%ip ) ! *ief m$ical (fic] or o!r simil> (ficial ( ! cov]$ entity t has ! same frequ5cy1 int5sity1 & level ( acc\ntability t exi/s 9 ! relation%ip betwe5 ! m$ical director ( a dep>tm5t ( ! cov]$ entity & ! *ief m$ical (fic] or o!r simil> (ficial ( ! cov]$ entity1 & is "u ! same type ( sup]vision & acc\ntability z any o!r director1 m$ical or o!rwise1 ( ! cov]$ entity4 7dd7 ,m$ical /aff committees or o!r pr(essional committees at ! cov]$ entity are responsible = m$ical activities 9 ! *ild site1 includ+ quality assurance1 utilization review1 & ! coord9ation & integration ( s]vices1 to ! ext5t practicable1 betwe5 ! *ild site & cov]$ entity4 7ee7 ,m$ical records = pati5ts treat$ 9 ! *ild site are integrat$ into a unifi$ retrieval sy/em1 or h ! ability to be readily access$ by ! cov]$ entity4 7ff7 ,inpati5t & outpati5t s]vices ( ! *ild site & ! cov]$ entity are integrat$1 & pati5ts treat$ at ! *ild site :o require fur!r c>e h full access to all s]vices ( ! cov]$ entity & are ref]r$ :]e appropriate to ! correspond+ inpati5t or outpati5t dep>tm5t or s]vice ( ! cov]$ entity4 7,,viii7 ,! f9ancial op]ations ( ! *ild site are fully integrat$ )9 ! f9ancial sy/em ( ! cov]$ entity1 z evid5c$ by %>$ income & exp5ses betwe5 ! cov]$ entity & ! *ild site4 ,= purposes ( ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act1 ! co/s ( a *ild site are report$ 9 ! appropriate co/ c5t] or co/ c5t]s ( ! cov]$ entity1 & ! f9ancial /atus ( any *ild site is incorporat$ & readily id5tifi$ 9 ! cov]$ entity's trial balance4 7,,ix7 ,! *ild site is held out to ! public z "p ( ! cov]$ entity4 ,:5 pati5ts ent] ! *ild site1 !y are aw>e t !y are ent]+ ! cov]$ entity4 7,x7 ,! *ild site is op]at$ "u ! own]%ip & control ( ! cov]$ entity1 z evid5c$ by ! foll[+3 7aa7 ,! bus9ess ent]prise t con/itutes ! *ild site is #ajj p]c5t own$ by ! cov]$ entity2 except t a *ild site may be jo9tly own$ if3 7,,aa7 ! cov]$ entity holds a majority own]%ip int]e/ ( n less ?an #ea p]c5t2 7,,bb7 ea* co-own] is ei!r3 7i7 an organization describ$ 9 section #eja7;c77#c7 ( ! ,int]nal ,rev5ue ,code ( #aihf & exempt f tax "u section #eja7;a7 ( su* ,code1 or 7ii7 a ,/ate or local gov]nm5tal entity1 includ+ a public univ]sity or academic m$ical c5t]2 7,,cc7 ea* co-own] t is n a cov]$ entity has1 indep5d5t ( ! jo9t v5ture1 a bona fide *>itable1 public heal?1 or gov]nm5tal mission t includes ! direct provision ( heal? c>e s]vices to l[-income1 un9sur$1 or m$ically und]s]v$ individuals2 7,,dd7 no co-own] is a =-pr(it entity2 7,,ee7 no co-own] t is n a cov]$ entity 0 =m$1 reorganiz$1 conv]t$1 or mat]ially re/ructur$ = ! purpose ( qualify+ z an eligible co-own] "u ?is subp>agraph2 & 7,,ff7 ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration has n det]m9$1 aft] notice & an opportunity to respond1 t ! jo9t v5ture /ructure 0 con/itut$ = ! purpose ( obta9+ eligibility "u ! drug disc\nt program "u ?is section or exp&+ claims = disc\nts "u su* program1 r ?an to fur!r ! heal? c>e mission ( ! cov]$ entity & ! heal? c>e ne$s ( ! pati5t population s]v$ by ! *ild site4 7bb7 ,! cov]$ entity & ! *ild site h ! same gov]n+ body4 7cc7 ,! *ild site is op]at$ "u ! same organizational docum5ts z ! cov]$ entity1 & is subject to common bylaws & op]at+ decisions ( ! gov]n+ body ( ! cov]$ entity4 7dd7 ,! cov]$ entity has f9al responsibility = adm9i/rative decisions1 f9al approval = contracts ) outside p>ties1 f9al approval = p]sonnel actions1 f9al responsibility = p]sonnel policies 7su* z fr+e b5efits or code ( conduct71 & f9al approval = m$ical /aff appo9tm5ts at ! *ild site4 7,,xi7 ,! report+ relation%ip betwe5 ! *ild site & ! cov]$ entity h ! same frequ5cy1 int5sity1 & level ( acc\ntability t exi/s 9 ! relation%ip betwe5 ! cov]$ entity & its o!r dep>tm5ts1 z evid5c$ by compliance ) all ( ! foll[+ requirem5ts3 7aa7 ,! *ild site is "u ! direct sup]vision ( ! cov]$ entity4 7bb7 ,! *ild site is op]at$ "u ! same monitor+ & ov]sight by ! cov]$ entity z any o!r dep>tm5t ( ! cov]$ entity1 & is op]at$ z any o!r dep>tm5t ( ! cov]$ entity ) reg>d to sup]vision & acc\ntability4 ,! director or individual responsible = daily op]ations at ! *ild site-- 7,,aa7 ma9ta9s a report+ relation%ip ) a manag] at ! cov]$ entity t has ! same frequ5cy1 int5sity1 & level ( acc\ntability t exi/s 9 ! relation%ip betwe5 ! cov]$ entity & its exi/+ dep>tm5ts2 & 7,,bb7 is acc\ntable to ! gov]n+ body ( ! cov]$ entity1 9 ! same mann] z any dep>tm5t head ( ! cov]$ entity4 7,,xii7 ,! foll[+ adm9i/rative functions ( ! *ild site are integrat$ ) ! functions ( ! cov]$ entity3 bill+ s]vices1 records1 human res\rces1 payroll1 employee b5efit package1 sal>y /ructure1 & pur*as+ s]vices4 ,ei!r ! same employees or gr\p ( employees h&le su* adm9i/rative functions = ! *ild site & ! cov]$ entity1 or ! adm9i/rative functions = bo? ! *ild site & ! cov]$ entity are-- 7aa7 contract$ out "u ! same contract agreem5t2 or 7bb7 h&l$ "u diff]5t contract agreem5ts1 ) ! contract ( ! *ild site be+ manag$ by ! cov]$ entity4 7,,xiii7 ,! *ild site 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 ! site w\ld be correctly includ$ on a reimbursable l9e ( a ,m$ic>e co/ report if ! cov]$ entity fil$ a co/ report74 ,su* co/ report demon/rates t ! s]vices provid$ at ! *ild site h associat$ co/s & *>ges = cov]$ entity 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 ! *ild site include or consi/ solely ( outpati5t s]vices74 7ii7 ,,hrsa deem+ 7,i7 ,9 g5]al ,if ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices has det]m9$ a site to be qualifi$ z a provid]-bas$ entity & 9 compliance ) ! provid]-bas$ requirem5ts "u section #dac4fe ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulations71 ! ,secret>y %all deem ! site to h met ! requirem5ts describ$ 9 clause 7i74 7,,ii7 ,rule ( con/ruction ,?is clause %all au?orize ! ,secret>y to e/abli% a process ?r\gh notice & comm5t rulemak+ to det]m9e :e!r a *ild site1 z det]m9$ by ! ,adm9i/rator ( ! ,c5t] = ,m$ic>e ,m$icaid ,s]vices1 complies ) ! ,m$ic>e provid]-bas$ rules4 7iii7 ,*ild site regi/ration3 community ne$ /&>d 7,i7 ,def9itions ,= purposes ( ?is subsection3 7aa7 ,! t]m *ild site has ! def9ition set =? 9 ,section #cdj;,b7b77#d74 7bb7 ,! t]m ,community ,vuln]ability ,score means ! p]c5tile rank+ assign$ to a ,,zip ,code ,tabulation ,area "u ! ,social ,vuln]ability ,index ma9ta9$ by ! ,c5t]s = ,disease ,control & ,prev5tion & ! ,ag5cy = ,toxic ,sub/ances & ,disease ,regi/ry 7,,cdc_/,,atsdr ,,svi71 or su* successor or supplem5t>y validat$ index z ! ,secret>y may designate by regulation1 on a scale ( #j to #a 9 :i* a score ( #a repres5ts maximum social vuln]ability4 ,! ,secret>y %all1 ?r\gh notice & comm5t rulemak+1 e/abli% a me?od = mapp+ or aggregat+ ! und]ly+ index to ! ,,zip ,code ,tabulation ,area level4 ,:]e ! ,secret>y designates a supplem5t>y or successor index1 ! ,secret>y %all ensure t su* index is bas$ on publicly available ,,zip ,code ,tabulation ,area-level or equival5t data1 updat$ at lea/ bi5nially1 & validat$ = use 9 id5tify+ m$ically und]s]v$ or socially vuln]able communities4 7cc7 ,! t]m p>5t entity means ! cov]$ entity ^: eligibility /atus "u subsection 7a77#d7 =ms ! basis = a *ild site's regi/ration4 7dd7 ,! t]m qualify+ ,,zip ,code means a ,,zip ,code ,tabulation ,area ) a ,community ,vuln]ability ,score at or above ! #ej? p]c5tile ?re%old :5 rank$ nationally--mean+ ! ,,zip ,code ,tabulation ,area falls )9 ! m vuln]able half ( all ,,zip ,code ,tabulation ,areas 9 ! ,unit$ ,/ates--or at or above ! #dj? p]c5tile ?re%old :5 rank$ aga9/ all ,,zip ,code ,tabulation ,areas )9 ! same ,/ate1 :i*ev] ?re%old ! cov]$ entity elects to apply4 ,if ! ,,zip ,code ,tabulation ,area 9 :i* a *ild site's /reet address is locat$ has n be5 assign$ a ,community ,vuln]ability ,score1 includ+ because ! area is unpopulat$1 non-resid5tial1 or o!rwise lacks ! und]ly+ data necess>y to compute su* a score1 ! qualify+ /atus ( su* area %all be det]m9$ bas$ on ! ,community ,vuln]ability ,score ( ! c5sus tract 9 :i* ! /reet address is locat$1 or if no su* score is available = t c5sus tract1 ! c\nty 9 :i* ! /reet address is locat$1 apply+ ! same national & ,/ate-relative p]c5tile ?re%olds describ$ 9 ?is subp>agraph4 ,! ,secret>y %all1 ?r\gh notice & comm5t rulemak+1 def9e ! circum/ances "u :i* a ,,zip ,code ,tabulation ,area is treat$ z unscor$ & e/abli% ano!r me?od = assign+ a ,community ,vuln]ability ,score4 7ee7 ,! t]m ,,zip ,code ,tabulation ,area means ! geographic unit designat$ by ! ,unit$ ,/ates ,c5sus ,bureau correspond+ to a #e-;digit ,,zip code1 consi/5t ) ! geographic units us$ by ! ,secret>y "u ?is subsection4 ,= purposes ( ?is subsection1 a *ild site's ,,zip ,code ,tabulation ,area %all be det]m9$ bas$ on ! fir/ five digits ( ! *ild site's /reet address ,,zip code z regi/]$ ) ! ,secret>y4 7,,ii7 ,community ne$ /&>d = *ild sites 7aa7 ,g5]al requirem5t ,a *ild site %all meet ! community ne$ /&>d e/abli%$ "u ?is p>agraph z a condition ( initial regi/ration & cont9u$ p>ticipation "u ?is section4 ,a *ild site meets su* /&>d if ! cov]$ entity demon/rates t ! *ild site is physically locat$ 9 a qualify+ ,,zip ,code ,tabulation ,area1 z det]m9$ us+ ! /reet address ( ! *ild site 9 a mann] specifi$ by ! ,secret>y ?r\gh notice & comm5t rulemak+4 7bb7 ,application to new *ild sites ,= a *ild site seek+ regi/ration on or aft] ! date ( enactm5t ( ?is subsection1 compliance ) item 7aa7 %all be det]m9$ by ! ,secret>y at ! "t ( initial regi/ration bas$ on ! ,,zip ,code ,tabulation ,area 9 :i* ! *ild site's /reet address is situat$1 z submitt$ by ! cov]$ entity4 7cc7 ,application to exi/+ *ild sites ,= a *ild site regi/]$ z ( ! date ( enactm5t ( ?is subsection1 compliance ) item 7aa7 %all be evaluat$ at ! "t ( ! next applicable rec]tification ( ! cov]$ entity4 ,= ! purposes ( apply+ ! community ne$ /&>d to a *ild site regi/]$ z ( ! date ( enactm5t ( ?is subsection1 ! ,secret>y %all det]m9e eligibility bas$ on ! ,,zip ,code ,tabulation ,area 9 :i* ! *ild site's /reet address is situat$ at ! "t ( su* rec]tification4 7dd7 ,ongo+ validation ,compliance ) ! community ne$ /&>d "u item 7aa7 %all be v]ifi$ = all *ild sites on an ongo+ basis ?r\gh ! annual rec]tification process1 or su* o!r p]iodic review z ! ,secret>y may e/abli%4 7ee7 ,failure to meet /&>d ,a *ild site t does n satisfy ! community ne$ /&>d "u item 7aa71 z det]m9$ by ! ,secret>y1 %all be subject to removal f ! cov]$ entity's regi/ration 9 accordance ) proc$ures e/abli%$ by ! ,secret>y1 includ+ notice & an opportunity to respond4 ,removal ( a *ild site f regi/ration "u ?is p>agraph %all n affect ! cont9u$ eligibility ( ! p>5t entity or any o!r *ild site ( ! p>5t entity t satisfies ! applicable /&>d4 7ff7 ,payor-mix exception ,not)/&+ item 7aa71 a *ild site t does n indep5d5tly meet ! community ne$ /&>d describ$ 9 item 7aa7 %all none!less be deem$ to meet su* /&>d if ! cov]$ entity demon/rates1 to ! satisfaction ( ! ,secret>y1 t n less ?an #dj p]c5t ( pati5ts s]v$ by ! *ild site are enroll$ 9 ,m$icaid1 are un9sur$1 or h incomes at or bel[ #bjj p]c5t ( ! ,f$]al pov]ty level1 z det]m9$ us+ pati5t data = ! mo/ rec5t #ab-mon? p]iod4 7gg7 ,safety-net exception ,! ,secret>y may grant a tempor>y exception f ! community ne$ /&>d "u item 7aa7 = a *ild site t does n o!rwise qualify "u item 7aa7 or 7ff71 if ! cov]$ entity demon/rates t-- 7,,aa7 ! *ild site provides prim>y c>e1 behavioral heal?1 sub/ance use treatm5t s]vices or o!r s]vices specifically direct$ at individuals :o are l[ income1 un9sur$1 or o!rwise m$ically und]s]v$ & = :i* !re is no adequate alt]native provid] )9 a reasonable geographic proximity--to a pati5t population t includes a significant proportion ( l[-income1 un9sur$1 or o!rwise m$ically und]s]v$ individuals2 & 7,,bb7 removal ( ! *ild site f regi/ration "u ?is section w\ld mat]ially r$uce access to su* s]vices = su* pati5t population4 ,any exception grant$ "u ?is subp>agraph %all be = a p]iod n to exce$ #b ye>s1 subject to r5ewal ^u re-demon/ration4 ,! ,secret>y %all promulgate regulations specify+ ! crit]ia & application process = exceptions "u ?is subp>agraph4 7hh7 ,rule ( con/ruction ,a *ild site %all n fail to satisfy ! community ne$ /&>d solely because ! p>5t entity is locat$ 9 a diff]5t ,,zip ,code ,tabulation ,area1 provid$ ! *ild site indep5d5tly satisfies ! requirem5ts ( ?is p>agraph4 7,,iii7 ,rulemak+ ,n lat] ?an #f mon?s aft] ! date ( enactm5t ( ?is subsection1 ! ,secret>y %all promulgate regulations to implem5t ?is subsection1 includ+ ! me?od = det]m9+ ! ,,zip ,code ,tabulation ,area 9 :i* a *ild site is locat$ "u item 7aa7 &1 :]e su* area is unscor$1 ! me?od = assign+ a ,community ,vuln]ability ,score4 ,9 promulgat+ su* regulations1 ! ,secret>y %all acc\nt = geographic disp>ities 9 national ,,svi rank+s by provid+ = a ,/ate-relative eligibility det]m9ation1 consi/5t ) ! ,/ate-relative ?re%old e/abli%$ 9 subp>agraph 7,i77dd71 ensur+ t *ild sites s]v+ communities ) relatively high social vuln]ability )9 _! ,/ate are n disadvantag$ solely by l[] absolute national p]c5tile rank+s4 7iv7 ,limitation ,only a *ild site 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 ( p>agraph 7#e77;,b74 4 #e4 ,improv+ pati5t af=dability & protections ,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 ,pati5t assi/ance programs 7,a7 ,9 g5]al ,cov]$ entities %all ma9ta9 & ext5d _! pati5t f9ancial assi/ance policy to pati5ts s]v$ by _! *ild sites & contract ph>macies4 ,! cov]$ entity %all ensure t its f9ancial assi/ance policy is transp>5t to pati5ts at po9t ( c>e1 satisfies ! notice requirem5ts 9 p>agraph 7,c71 & publicly report$4 ,! ,secret>y %all e/abli% a process1 ?r\gh notice & comm5t rulemak+1 to require cov]$ entities to ma9ta9 auditable records relat$ to ! implem5tation & en=cem5t ( ?is p>agraph4 ,no?+ 9 ?is section %all be con/ru$ to require a cov]$ entity to waive or elim9ate all pati5t co/-%>+ or o!r out-(-pocket obligations1 or to provide cov]$ outpati5t drugs or relat$ s]vices at no co/1 except to ! ext5t requir$ "u ! cov]$ entity's g5]ally applicable f9ancial assi/ance policy4 7,b7 ,f9ancial assi/ance policy def9$ ,9 ?is p>agraph1 a f9ancial assi/ance policy means a writt5 f9ancial assi/ance policy describ$ 9 section #eja7r77#d77;,a7 ( ! ,int]nal ,rev5ue ,code ( #aihf1 provid$ to pati5ts-- 7i7 up to at lea/ #djj p]c5t ( ! ,f$]al pov]ty level1 = cov]$ entities describ$ "u subp>agraph 7,l71 7,m71 7,n71 & 7,o7 ( subsection 7a77#d72 7ii7 up to at lea/ #bjj p]c5t ( ! ,f$]al pov]ty level1 = all cov]$ entities n describ$ 9 p>agraph #ad7;b77i7 t are n o!rwise subject to slid+ fee s*$ule or grant requirem5ts by law2 & 7iii7 a slid+ fee scale = cov]$ outpati5t drugs disp5s$ to pati5ts "u ! drug disc\nt program "u ?is section1 z applicable1 provid$ t-- 7,i7 = cov]$ entities describ$ "u subp>agraph 7,l71 7,m71 7,n71 & 7,o7 ( subsection 7a77#d7-- 7aa7 su* slid+ fee s*$ule mu/ be made available = all pati5ts up to at lea/ #djj p]c5t ( ! ,f$]al pov]ty level2 & 7bb7 copaym5t requirem5ts "u su* slid+ fee s*$ule mu/ be nom9al 9 am\nt2 or 7,,ii7 su* o!r alt]native policy z ! ,secret>y may det]m9e ?r\gh notice & comm5t rulemak+ ) respect to a specific cov]$ entity4 7,c7 ,notice 7i7 ,cov]$ entities %all provide adequate notice & application ( any f9ancial assi/ance policy describ$ 9 subp>agraph 7,a74 7ii7 ,9 ord] to ensure mean+ful und]/&+ ( eligibility ( a pati5t = a f9ancial assi/ance policy1 any notice describ$ 9 clause 7i7 mu/ be made available to pati5ts ( ! cov]$ entity-- 7,i7 9 a pla9-language summ>y 7z def9$ 9 #db ,u4,s4 ,code #ahjca7;e77#c77;,b77 9 ,engli%2 & 7,,ii7 if ,engli% is n ! prim>y language 9 ! community s]v$ by ! cov]$ entity1 9 ! prim>y language s]v$ by su* community4 7,d7 ,implem5tation = contract ph>macies ,! f9ancial assi/ance policies "u ?is section %all apply to contract ph>macies by ! foll[+ timel9e3 7i7 prospectively to all newly regi/]$ contract ph>macy locations aft] ! enactm5t ( ?is clause2 or 7ii7 n lat] ?an #c ye>s aft] ! date ( enactm5t ( ?is clause = all o!r contract ph>macy locations4 7,e7 ,ov]sight ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy & report to ,congress on ! impact ( requirem5ts ( ?is p>agraph on pati5t access to cov]$ outpati5t drugs pur*as$ "u ?is section4 7,f7 ,rule ( con/ruction ,compliance ) ?is p>agraph %all n be consid]$ a prohibit$ act "u section #aabh;,a1 #aabh;,b7b71 or #ahgg ( ! ,social ,security ,act4 7#af7 ,m$ical debt 7,a7 ,prohibitions 7i7 ,9 g5]al ,cov]$ entities describ$ "u subp>agraph 7,l71 7,m71 7,n71 & 7,o7 ( subsection 7a77#d7 %all n-- 7,i7 sell a pati5t's debt to ano!r p>ty2 7,,ii7 report adv]se in=mation ab\t an individual to consum] cr$it report+ ag5cies or cr$it bureaus2 & 7,,iii7 def] or d5y1 or require a paym5t be=e provid+1 m$ically necess>y c>e1 because ( an individual's non-paym5t ( "o or m bills4 7ii7 ,exception ,a cov]$ entity describ$ "u subp>agraph 7,l71 7,m71 7,n71 & 7,o7 ( subsection 7a77#d7 may sell an individual's debt to ano!r p>ty if ! p>ty's sole purpose is to pay = ! individual's debt 9 full4 7,b7 ,debt collection 7i7 ,9 g5]al ,except z provid$ 9 clause 7ii71 cov]$ entities describ$ "u subp>agraph 7,l71 7,m71 7,n71 & 7,o7 ( subsection 7a77#d7 %all n take any legal action to collect debt f a pati5t at su* cov]$ entity4 7ii7 ,exception ,a cov]$ entity describ$ "u subp>agraph 7,l71 7,m71 7,n71 & 7,o7 ( subsection 7a77#d7 may collect debt only f pati5ts ) a cle> ability to pay1 z demon/rat$ by ! great] (-- 7,i7 income at or above #fjj p]c5t ( ! ,f$]al pov]ty level2 or 7,,ii7 assets valu$ at m ?an #djj p]c5t ( ! pati5t's out/&+ balance ( debt ow$ to ! cov]$ entity4 7iii7 ,int]e/ ,a cov]$ entity describ$ "u subp>agraph 7,l71 7,m71 7,n71 & 7,o7 ( subsection 7a77#d7 %all be prohibit$ f *>g+ int]e/ on any out/&+ balance ( debt ow$ by a pati5t to su* cov]$ entity t is m ?an ! all[able p]c5tage specifi$ 9 ! applicable usury laws or regulations ( ! ,/ate 9 :i* ! cov]$ entity is locat$4 7,c7 ,monitor+ compliance 7i7 ,9 g5]al ,! ,secret>y %all conduct an annual review1 9 a =m & mann] e/abli%$ 9 regulations to be promulgat$ by ! ,secret>y n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is subp>agraph1 to monitor cov]$ entity compliance ) ! requirem5ts ( ?is p>agraph4 7ii7 ,en=cem5t ,if ! ,secret>y f9ds t1 z a result ( a review describ$ 9 clause 7i71 a cov]$ entity is n 9 compliance ) ! requirem5ts ( ?is p>agraph1 ! ,secret>y %all-- 7,i7 impose civil monet>y p5alties1 :i*-- 7aa7 %all be assess$ accord+ to /&>ds e/abli%$ 9 regulations to be promulgat$ by ! ,secret>y n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is subclause2 & 7bb7 %all n exce$ #e1jjj = ea* in/ance ( noncompliance t may h occurr$2 7,,ii7 :]e ! ,secret>y det]m9es t a violation ( ?is p>agraph 0 sy/ematic & egregi\s z well z kn[+ & int5tional1 ref] matt]s to appropriate au?orities )9 ! ,(fice ( ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices2 & 7,,iii7 :]e ! ,secret>y det]m9es t a cov]$ entity may n be 9 compliance ) ! requirem5ts ( section #eja7r7 ( ! ,int]nal ,rev5ue ,code ( #aihf1 ref] matt]s to appropriate au?orities )9 ! ,int]nal ,rev5ue ,s]vice4 7,d7 ,,gao report ,n lat] ?an #b ye>s aft] ! enactm5t ( ?is subp>agraph1 & e #b ye>s !reaft]1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,secret>y & to ! appropriate committees ( ,congress a report t-- 7i7 analyzes cov]$ entity compliance ) ! requirem5ts describ$ 9 ?is p>agraph2 & 7ii7 makes recomm5dations ) respect to policies int5d$ to improve compliance ) ! requirem5ts describ$ 9 ?is p>agraph4 7,e7 ,inspector g5]al report ,! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all conduct an annual risk-bas$ assessm5t ( cov]$ entity compliance ) ! requirem5ts ( ?is p>agraph4 4 #f4 ,data report+ = transp>5cy ,section #cdj;,b7d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7d77 is am5d$ by add+ at ! end ! foll[+3 7#e7 ,report+ ( program sav+s 7,a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is p>agraph1 & annually !reaft]1 ea* cov]$ entity %all report to ! ,secret>y1 z an add5dum to ! ,m$ic>e co/ report mo/ rec5tly submitt$ by su* entity1 or 9 ! case ( a cov]$ entity t does n submit a ,m$ic>e co/ report1 by direct report to ! ,secret>y1 ! foll[+ in=mation ) respect to ! entity1 includ+ all sites & contract ph>macy arrangem5ts ( ! entity1 = ! prec$+ ye>3 7i7 ,! total numb] ( individuals :o 7 disp5s$ or adm9i/]$ cov]$ outpati5t drugs pur*as$ "u ?is section dur+ su* prec$+ ye> t 7 subject to an agreem5t "u subsection 7a77#a74 7ii7 ,! total numb] ( prescriptions fill$ ) cov]$ outpati5t drugs pur*as$ "u ?is section & bill$ to insurance1 organiz$ by type ( heal? insurance cov]age 7z specifi$ by ! ,secret>y ?r\gh notice & comm5t rulemak+1 includ+ by ! ,m$ic>e program "u title ,,xviii ( ! ,social ,security ,act1 ! ,m$icaid program "u title ,,xix ( su* ,act1 ! ,*ildr5's ,heal? ,insurance ,program "u title ,,xxi ( su* ,act1 heal? insurance cov]age (f]$ 9 ! individual or gr\p m>ket or a gr\p heal? plan 7z su* t]ms are def9$ 9 section #bgia71 & un9sur$74 7iii7 7,i7 ,! co/ incurr$ at ea* site = *>ity c>e1 bas$ on ! *>ity c>e level ( ! cov]$ entity1 def9$ z a fraction1 ! num]ator ( :i* is ! am\nt ( *>ity c>e report$ on work%eet ,s-#aj ( ! ,m$ic>e co/ report 7or any successor71 & ! d5om9ator ( :i* is ! total op]at+ co/ ( ! hospital1 z report$ = ! mo/ rec5t co/ report+ p]iod2 or 7,,ii7 9 ! case ( a cov]$ entity t is n requir$ to submit a ,m$ic>e co/ report t indicates *>ity c>e levels1 a qualitative description ( ! *>ity c>e provid$ by su* entity1 9 ! aggregate1 9 su* mann] t is n ov]ly burd5some to cov]$ entities1 z ! ,secret>y may require ?r\gh notice & comm5t rulemak+4 7iv7 ,a description ( ! cov]$ entity's use ( ! sav+s receiv$ ?r\gh p>ticipation 9 ! drug disc\nt program "u ?is section1 includ+ a description ( heal? c>e s]vices or heal?-relat$ b5efits us$ to b5efit ! pati5ts & communities s]v$ by ! cov]$ entity1 del9eat$ by categories ( s]vices & b5efits & populations s]v$1 includ+ su* s]vices & b5efits provid$ to und]s]v$ & un9sur$ pati5ts & communities4 7v7 ,! f9ancial demographics ( pati5ts ( ! cov]$ entity1 includ+-- 7,i7 ! p]c5tage ( pati5ts eligible = f9ancial assi/ance programs & slid+ scale fees2 7,,ii7 ! p]c5tage ( pati5ts :o reside 9 a heal? pr(essional %ortage area 7z def9$ 9 section #ccb7 or a m$ically und]s]v$ community 7z def9$ 9 section #gii;,b71 or :o are "p ( a m$ically und]s]v$ population 7z def9$ 9 section #ccj7;b77#c771 & ! p]c5tage ( un9sur$ pati5ts2 7,,iii7 ! p]c5tage pati5ts :o are ,m$icaid b5efici>ies2 7,,iv7 ! p]c5tage ( pati5ts :o are ,*ildr5's ,heal? ,insurance ,program b5efici>ies2 7,v7 to ! ext5t data are available1 ! p]c5tage ( pati5ts e>n+ bel[ ea* ( ea* ( ! foll[+ levels ( ! ,f$]al ,pov]ty ,level3 #ajj p]c5t1 #bjj p]c5t1 #cjj p]c5t1 & #djj p]c5t2 & 7,,vi7 ! numb] ( pati5ts :o receive assi/ance f ano!r p>ty 9 pay+ = a prescription drug & ! mean am\nt ( disc\nt or b5efit receiv$4 7vi7 ,policies ( ! cov]$ entity to-- 7,i7 promote access & adh]5ce to prescrib$ m$ications2 & 7,,ii7 promote access to prescription m$ic9es = pati5ts e>n+ "u #bjj p]c5t ( ! ,f$]al ,pov]ty ,level4 7vii7 ,9 ! case ( a nongov]nm5tal hospital1 any contracts betwe5 su* hospital & a ,/ate or local gov]nm5tal entity1 & any modifications to any su* contract4 7viii7 ,any ?ird-p>ty adm9i/rators 9 contract ) ! cov]$ entity = ! adm9i/ration ( ! drug disc\nt program4 7ix7 ,! fund+ %ortfall = ! cov]$ entity attributable to s]vices provid$ to ,m$ic>e & ,m$icaid b5efici>ies1 z report$ on ! ,int]nal ,rev5ue ,s]vice ,=m #iij4 7x7 ,! numb] ( pati5ts us+ ! outpati5t s]vices ( ! cov]$ entity4 7xi7 ,op]ation co/s to ! cov]$ entity relat$ to ! drug disc\nt program "u ?is section4 7xii7 ,! names & addresses ( all contract ph>macy locations4 7xii7 ,utilization rates ( outpati5t hospital s]vices furni%$ to pati5ts e>n+ bel[ ea* ( ! foll[+ level ( ! ,f$]al ,pov]ty ,level3 #ajj p]c5t1 #bjj p]c5t1 #cjj p]c5t1 & #djj p]c5t4 7,b7 ,records ret5tion ,cov]$ entities %all reta9 su* records = a p]iod ( at lea/ #c ye>s & provide su* records & reports pursuant to /&>ds e/abli%$ by ! ,secret>y ?r\gh notice & comm5t rulemak+ = purposes ( c>ry+ out ?is p>agraph4 7,c7 ,availability ( in=mation 7i7 ,9 g5]al ,n lat] ?an #cj days aft] receiv+ ! in=mation report$ by cov]$ entities "u subp>agraph 7,a71 ! ,secret>y %all publi% su* in=mation on ! public website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 :i* may include ! website ( ! #cdj;,b ,(fice ( ,ph>macy ,affairs ,in=mation ,sy/em 7or a successor to su* sy/em74 7ii7 ,=mat ,data publi%$ "u clause 7i7 %all be publi%$ 9 an electronic & se>*able =mat t %[s ea* category ( data report$ bo? 9 ! aggregate & id5tifi$ by individual cov]$ entity7ies7 describ$ 9 subsection 7a77#d74 ,9 c>ry+ out ?is p>agraph1 ) respect to data report$ pursuant to subp>agraph 7,a71 ! ,secret>y %all ensure t any propriet>y in=mation be r$act$ f contracts submitt$ pursuant to p>agraph 7#e77;,a77vii7 be=e po/+ su* contracts4 7,d7 ,reports to congress ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is subp>agraph1 & annually !reaft]1 ! ,secret>y %all submit a report to ,congress on ! in=mation collect$ "u subp>agraph 7,a74 7,e7 ,regulations ,! ,secret>y %all promulgate regulations to c>ry out ?is p>agraph4 4 #g4 ,enhanc+ program integrity 7a7 ,audits 7#a7 ,9 g5]al ,section #cdj;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7 is fur!r am5d$ by add+ at ! end ! foll[+ new subsection3 7g7 ,audits by ! secret>y 7#a7 ,9 g5]al ,9 addition to ! audits o!rwise au?oriz$ "u ?is section1 ! ,secret>y may audit cov]$ entities1 includ+ ! contract ph>macies & *ild sites ( su* entities1 & manufactur]s to assess compliance ) requirem5ts "u ?is section1 includ+ id5tify+ any /atutory violations relat$ to3 improp]ly claim+ eligibility = ! program "u ?is section1 drug div]sion1 duplicate disc\nts1 use ( contract ph>macies1 claim+ ( a disc\nt "u ?is section on a drug t is n a cov]$ outpati5t drug pur*as$ "u ?is section1 or fail+ to provide an accurate ceil+ price4 7#b7 ,/&>ds ,! ,secret>y %all conduct audits describ$ 9 ?is section 9 accordance ) g5]ally accept$ /&>ds1 z may be prescrib$ by ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates1 & %all make ! protocol = su* audits publicly available4 7#c7 ,requirem5ts ,! ,secret>y may n close an audit describ$ 9 p>agraph 7#a7 be=e a corrective action plan requir$ by ! ,secret>y has be5 fully implem5t$1 z applicable4 7#d7 #cdj;b v5dor in=mation ,to meet ! requirem5ts = submission ( in=mation = audits "u ?is clause1 cov]$ entities %all contract only ) v5dors agree+ to-- 7,a7 submit data to ! ,secret>y & indep5d5t auditors contract+ ) cov]$ entities necess>y to det]m9e ! cov]$ entity's compliance ) /atutory & regulatory requirem5ts "u ?is program1 prohibitions on drug div]sion & duplicate disc\nts1 use ( contract ph>macies1 & claims = disc\nts on cov]$ outpati5t drugs pur*as$ pursuant to agreem5ts "u subsection 7a77#a72 & 7,b7 respond to reque/s f auditors 9 a timely mann]4 7#e7 ,consequ5ces ( audit ,! ,secret>y %all ensure t1 9 ! case ( an audit f9d+ t an entity did n meet "o or m ( ! eligibility crit]ia = be+ a cov]$ entity1 z def9$ 9 subsection 7a77#d71 ! full p]iod "u review 9 an audit1 ! audit results 9 consequ5ces t are consi/5t & appropriate ) ! violation1 :i* may include dis5rollm5t1 & t d n treat ! failure to meet eligibility crit]ia z an issue t c be correct$ retroactively4 ,no?+ 9 ?is subsection %all be con/ru$ to limit ! au?ority ( ! ,secret>y to impose any rem$y or consequ5ce o!rwise available "u ?is ,section4 7#f7 ,regulations ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is p>agraph1 ! ,secret>y %all promulgate regulations to e/abli% ! audit & report+ proc$ures requir$ by ?is subsection4 7h7 ,indep5d5t audits ( cov]$ entities & contract ph>macy locations 7#a7 ,on a bi5nial basis1 ea* cov]$ entity %all engage an indep5d5t auditor to conduct an audit ( ! cov]$ entity's & ea* ( its *ild site's & contract ph>macy location's compliance ) ?is section4 ,! indep5d5t auditor %all n-- 7,a7 h any direct or indirect f9ancial int]e/ 9 ! cov]$ entity or its contract ph>macy2 7,b7 h any decision-mak+ au?ority ) respect to ! cov]$ entity2 or 7,c7 int]v5e ) ! gov]nance ( ! cov]$ entity4 7#b7 ,^u conclusion ( ea* audit1 ea* cov]$ entity %all-- 7,a7 review ! me?odology us$ by ! auditor to id5tify ! full scope ( any noncompliance2 7,b7 id5tify & fully correct all violations t h be5 id5tifi$ 9 su* indep5d5t audit ( ! cov]$ entity2 7,c7 take /eps to prev5t su* violations effectively 9 ! future2 7,d7 specifically disclose to ! ,secret>y-- 7i7 ! me?odology us$ by ! indep5d5t auditor describ$ 9 subp>agraph 7,a72 7ii7 ! nature & ext5t ( any id5tifi$ non-compliance2 & 7iii7 /eps tak5 to prev5t su* violations effectively 9 ! future2 7,e7 assign responsibility to c]tify ! audit results make corrections "u subp>agraph 7,b7 to a corporate (fic] ( ! cov]$ entity2 & 7,f7 )9 a reasonable "t p]iod1 disclose to ! manufactur] ( ! affect$ cov]$ outpati5t drug any pur*ase made "u ! drug disc\nt program "u ?is section t1 at ! "t ( ! pur*ase ( su* drug1 did n fully satisfy ! requirem5ts ( ! program4 ,if ! aggregate am\nt ow$ to a manufactur] z a result ( an audit "u ?is subsection exce$s ! de m9imis ?re%old e/abli%$ by ! ,secret>y ?r\gh notice & comm5t rulemak+1 ! cov]$ entity %all repay ! manufactur] an am\nt equal to ! r$uction 9 ! price ( ! affect$ drugs1 plus int]e/ on su* am\nt calculat$ us+ ! applicable %ort-t]m int]e/ rate det]m9$ by ! ,secret>y ( ! ,treasury "u section #abgd7;d7 ( ! ,int]nal ,rev5ue ,code ( #aihf = ! p]iod = :i* ! cov]$ entity is liable4 ,9 e/abli%+ ! de m9imis ?re%old1 ! ,secret>y %all consid] ! adm9i/rative co/s associat$ ) calculat+1 process+1 & receiv+ repaym5ts4 ,am\nts may n be divid$1 allocat$1 or o!rwise /ructur$ = ! purpose ( avoid+ ! repaym5t requirem5t "u ?is subp>agraph4 7#c7 ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is p>agraph1 ! ,secret>y %all-- 7,a7 promulgate regulations gov]n+ h[ auditors engag$ by cov]$ entities "u ?is subsection %all det]m9e :e!r & to :at ext5t a cov]$ entity is meet+ its requirem5ts "u ?is section1 includ+ requirem5ts reg>d+ nonpr(it /atus & any contract requir$ "u subsection 7a77#d77,l77i71 z applicable2 & 7,b7 promulgate regulations to e/abli% ! audit & report+ proc$ures requir$ by ?is subsection4 4 7#b7 ,additional sanctions au?ority ,section #cdj;,b7d77#b77;,b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7d77#b77;,b77 is am5d$-- 7,a7 9 clause 7v77,,ii71 by ins]t+ or :]e ! cov]$ entity fails to implem5t a corrective action plan relat+ to a violation involv+ improp]ly claim+ eligibility = ! drug disc\nt program "u ?is section1 drug div]sion1 duplicate disc\nts1 compliance ) contract ph>macy requirem5ts1 or claim+ a disc\nt or rebate on a drug t is n a cov]$ outpati5t drug1 )9 #f mon?s ( ! ,secret>y notify+ ! entity ( ! requirem5t = su* plan aft] kn[+ & int5tional12 & 7,b7 by add+ at ! end ! foll[+3 7vi7 ,increas+ ! frequ5cy ( audits conduct$ = entities previ\sly f\nd to be 9 violation ( requirem5ts ( ! drug disc\nt program "u ?is section t relate to eligibility1 drug div]sion1 duplicate disc\nts1 compliance ) contract ph>macy requirem5ts1 or claim+ a disc\nt or rebate on a drug t is n a cov]$ outpati5t drug1 & assign+ responsibility = mak+ corrections relat+ to su* a violation to a corporate (fic] ( ! entity4 7vii7 ,e/abli%+-- 7,i7 a process by :i* ! ,secret>y provides = prop] & timely notification ( a pot5tial violation by a cov]$ entity1 includ+ ! specific basis = ! pot5tial violation & ! in=mation reli$ ^u by ! ,secret>y 9 id5tify+ su* pot5tial violation2 7,,ii7 a process = a cov]$ entity to develop1 submit1 & implem5t a corrective action plan1 subject to approval & monitor+ by ! ,secret>y1 :i* %all-- 7aa7 provide two mon?s to submit a corrective action plan foll[+ notification ( a pot5tial violation "u subclause 7,i72 7bb7 require ! ,secret>y1 n lat] ?an #b mon?s aft] ! date ( submission ( su* plan1 to approve ! plan or reque/ *anges to ! plan2 & 7cc7 require su* plan to id5tify ! specific basis = ! f9d+ ( noncompliance & ! actions ! cov]$ entity w take to correct su* noncompliance1 prev5t recurr5ce1 & demon/rate ongo+ compliance2 7,,iii7 /&>ds = timel9es = correction & demon/ration ( compliance t are reasonable & proportionate to ! nature1 scope1 & sev]ity ( ! violation1 includ+ ! ext5t ( any affect$ claims1 ! risk ( div]sion or duplicate disc\nts1 & :e!r ! violation reflects isolat$ error1 repeat$ conduct1 or willful disreg>d ( applicable requirem5ts2 7,,iv7 circum/ances "u :i*1 dur+ ! p]iod 9 :i* a corrective action plan is 9 effect1 ! ,secret>y may tempor>ily susp5d ! cov]$ entity's eligibility to p>ticipate 9 ! drug disc\nt program "u ?is section1 if ! ,secret>y det]m9es t su* susp5sion is necess>y to protect program integrity1 includ+ cases involv+ willful disreg>d1 repeat$ or egregi\s noncompliance1 failure to respond to a ,secret>y-approv$ audit1 or failure to implem5t a prior corrective action plan2 & 7,v7 a process = ! ,secret>y to publicly report1 9 a de-id5tifi$ mann]1 on ! types & scope ( violations f\nd 9 audits conduct$ "u ?is section4 7viii7 ,dis5roll+ f ! program cov]$ entities t fail to implem5t a corrective action plan & correct violations 9 accordance ) ! "t frame set =? 9 ! ,corrective ,action ,plan pursuant to ! process describ$ 9 subp>agraph 7,b77vii71 relat$ to any /atutory violation ( ?is section4 7ix7 ,! imposition ( civil monet>y p5alties1 :i* %all be assess$ accord+ to /&>ds e/abli%$ 9 regulations to be promulgat$ by ! ,secret>y1 = cov]$ entities t kn[+ly or int5tionally cont9ue to contract ) ?ird-p>ty adm9i/rators or contract ph>macies t are n 9 compliance ) ! requirem5ts ( subsection 7a77#ac74 7x7 ,not)/&+ ! =ego+1 if ! ,secret>y det]m9es t a cov]$ entity has engag$ 9 a patt]n ( noncompliance1 z evid5c$ by3 7#a7 #c or m sep>ate f9al audit reports f9d+ violations ( ! requirem5ts ( ?is section )9 a #b-ye> p]iod1 or 7#b7 #e or m su* reports )9 a #e-ye> p]iod4 ,! ,secret>y may take any "o or m ( ! foll[+ actions ) respect to su* repeat noncompliant entity3 7,a7 require ! entity to implem5t an accel]at$ corrective action plan )9 a timeframe det]m9$ appropriate by ! ,secret>y2 7,b7 impose civil monet>y p5alties )\t provid+ an additional p]iod = corrective action2 or 7,c7 remove ! entity f ! drug disc\nt program "u ?is section & disqualify ! entity f re-entry into su* program = a p]iod ( "t det]m9$ by ! ,secret>y4 4 7b7 ,private non-,pr(it hospital eligibility bas$ on contracts ) /ate or local gov]nm5ts meet+ specifi$ crit]ia ,section #cdj;,b7a77#e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77#e771 z am5d$ by ! prec$+ sections1 is fur!r am5d$ by add+ at ! end ! foll[+3 7,e7 ,private non-pr(it hospital eligibility bas$ on contracts ) /ate or local gov]nm5ts meet+ specifi$ crit]ia ,9 ! case ( a hospital1 :e!r regi/]$ or seek+ to regi/] = ! drug disc\nt program "u ?is section z a cov]$ entity describ$ "u subp>agraph 7,l71 7,m71 7,n71 or 7,o7 ( p>agraph 7#d71 t claims to be eligible = ! program by virtue ( be+ a private non-pr(it hospital t has a contract ) a ,/ate or local gov]nm5t to provide heal? c>e s]vices to l[-income individuals :o are n eligible = ,m$icaid or ,m$ic>e1 ! ,secret>y %all take all ( ! foll[+ /eps1 ea* ( :i* %all be docum5t$3 7i7 ,prior to regi/]+ or approv+ annual rec]tification ( su* a hospital 7or :ile c>ry+ out any program audit ( su* a hospital71 ! ,secret>y %all obta9 & review ! hospital's contract ) a ,/ate or local gov]nm5t & %all v]ify & docum5t t-- 7,i7 ! docum5t provid$ by ! hospital is a contract1 9 t x is a mutually b9d+ agreem5t = ! hospital to provide heal? c>e s]vices or supplies 9 ex*ange = some?+ ( value2 7,,ii7 ! contract cle>ly li/s ! "n ( ! hospital & ! unit ( ,/ate or local gov]nm5t t are p>ties to ! contract & is sign$ & appropriately dat$ by appropriate (ficials ( ! hospital & ! unit ( ,/ate or local gov]nm5t2 7,,iii7 ! contract specifies an effective date2 7,,iv7 ! contract cle>ly is 9 effect & n expir$ at ! "t ( regi/ration 7or at ! "t ( rec]tification1 9 ! case ( annual rec]tification1 or = ! full p]iod exam9$ 9 an audit1 9 ! case ( an audit72 & 7,v7 ! contract explicitly requires t ! hospital provide heal? c>e s]vices1 & t su* s]vices mu/ be provid$ to individuals :o are bo? l[-income & n eligible = ei!r ! ,m$icaid program or ! ,m$ic>e program4 7ii7 ,! ,secret>y %all v]ify ! exi/5ce ( contracts meet+ ! requirem5ts ( clause 7i7 = all cov]$ entities describ$ 9 ?is subp>agraph & regi/]$ z ( ! date ( enactm5t ( ?is clause by no lat] ?an #a ye> aft] ! date ( enactm5t ( ?is clause4 7iii7 ,! ,secret>y %all n regi/] or rec]tify any cov]$ entity describ$ 9 ?is subp>agraph if ! entity's contract ) a ,/ate or local gov]nm5t does n satisfy subclauses 7,i7 ?r\gh 7,v7 ( clause 7i74 4 7c7 ,v]ification ( c]ta9 cov]$ entities ,section #cdj;,b7a77#d77,l77i7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77#d77,l77i77 is am5d$ by ins]t+ 7provid$ t su* a private non-pr(it hospital annually submits to ! ,secret>y v]ification ( su* an active contract ) a ,/ate or local gov]nm5t & v]ification ( its non-pr(it /atus7 be=e ! semicolon4 7d7 ,am5dm5t ,section #cdj;,b7a77#g7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77#g77 is am5d$ by ins]t+ at ! end ! foll[+3 7,f7 ,non-pr(it /atus ,! ,secret>y %all v]ify ! non-pr(it /atus ( any hospital1 :e!r regi/]$ or seek+ to regi/] = ! drug disc\nt program z a cov]$ entity describ$ "u subp>agraph 7,l71 7,m71 7,n71 or 7,o7 ( subsection 7a77#d71 t claims1 9 connection ) drug disc\nt program regi/ration1 annual rec]tification1 or an audit1 to meet drug disc\nt program eligibility crit]ia 9 "p by be+ a private non-pr(it hospital4 ,! ,secret>y %all v]ify ! non-pr(it /atus ( all su* hospitals us+ reliable publicly available in=mation1 su* z by mat*+ data report$ by hospitals aga9/ data f ! ,int]nal ,rev5ue ,s]vice or f ! ,c5t]s = ,m$ic>e & ,m$icaid ,s]vices on ! hospital's ,f$]al tax /atus4 ,! ,secret>y %all v]ify all regi/]$ cov]$ entities describ$ "u ?is section are 9 compliance ) ^! requirem5ts )9 "o ye> ( ! enactm5t ( ?is subp>agraph4 4 #h4 ,facilitat+ data ex*ange to improve program integrity ,"p ,a ( title ,,xi ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acja et seq47 is am5d$ by add+ ! foll[+ new section3 #aaej;,d4 #cdj;,b drug disc\nt program data cle>+h\se 7a7 ,g5]al ,= a p]iod ( f\r 7#d7 ye>s f ! enactm5t ( ?is section1 a manufactur] %all (f] cov]$ outpati5t drugs at ! ceil+ price requir$ "u section #cdj;,b7a77#a7 ( ! ,public ,heal? ,s]vice ,act z a r$uction 9 ! pur*ase price & n ?r\gh retrospective rebates or o!r po/-sale paym5ts4 ,?is obligation %all n apply to rebates = ! ,,aids ,drug ,assi/ance ,programs :o h implem5t$ a rebate model prior to ! effective date ( ?is section4 7b7 ,cle>+h\se p]=mance ,not)/&+ any o!r provision ( ?is section1 ! obligation "u subsection 7a7 %all automatically conclude at ! end ( ! p]iod describ$ 9 su* subsection if ! ,secret>y has n c]tifi$1 9 a public report validat$ by ! ,(fice ( ,inspector ,g5]al1 t ! conditions describ$ 9 p>agraphs 7#a7 ?r\gh 7#d7 h be5 satisfi$4 ,if su* c]tification is n made z ( ! end ( ! p]iod describ$ 9 subsection 7a71 no provision ( ?is subsection %all be con/ru$ to impose any additional or cont9u+ limitation on ! =m1 tim+1 or me*anism by :i* a manufactur] makes available ! ceil+ price requir$ "u section #cdj;,b7a77#a7 ( ! ,public ,heal? ,s]vice ,act-- 7#a7 all claims = #cdj;,b drugs describ$ 9 subsection 7g7 are submitt$ to1 & process$ ?r\gh1 ! cle>+h\se entity ) a contract 9 effect "u subsection 7f72 7#b7 n less ?an #ij p]c5t ( ! value ( su* claims submitt$ dur+ ! mo/ rec5t #ab-mon? p]iod are id5tifi$ by su* cle>+h\se entity z unique transactions t d n result 9 duplicate disc\nts or o!r applicable ov]lapp+ price concessions2 7#c7 n less ?an #ij p]c5t ( ! value ( claims = #cdj;,b drugs z describ$ 9 subsection 7g7 are adjudicat$1 includ+ id5tification ( any duplicate disc\nts1 rebates1 or o!r ov]lapp+ price concessions1 )9 timeframes e/abli%$ by ! ,secret>y ?r\gh notice & comm5t rulemak+2 & 7#d7 n less ?an #ie p]c5t ( ! value ( claims = #cdj;,b drugs z describ$ 9 subsection 7g7 conta9 ! data elem5ts requir$ by ! ,secret>y & are det]m9$ to be complete & accurate at ! "t ( initial submission4 7c7 ,ongo+ validation ( cle>+h\se p]=mance 7#a7 ,p]iodic oig reports ,if ! obligation "u subsection 7a7 rema9s 9 effect aft] ! end ( ! #d-ye> p]iod describ$ 9 subsection 7a71 ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all issue public reports evaluat+ :e!r ! cle>+h\se entity ) a contract 9 effect "u subsection 7f7 cont9ues to satisfy ! p]=mance b5*m>ks describ$ 9 subsection 7b74 ,su* reports %all be issu$-- 7,a7 n lat] ?an #b ye>s aft] ! end ( ! #d-ye> p]iod describ$ 9 subsection 7a72 7,b7 n lat] ?an #e ye>s aft] ! end ( ! #d-ye> p]iod describ$ 9 subsection 7a72 & 7,c7 e #e ye>s !reaft]4 7#b7 ,cont5ts ,ea* report "u p>agraph 7#a7 %all assess1 ) respect to ! mo/ rec5t #ab-mon? p]iod = :i* data are available1 :e!r ! p]=mance b5*m>ks describ$ 9 subsection 7b7 cont9ue to be satisfi$4 7#c7 ,corrective p]iod ,if a report issu$ "u p>agraph 7#a7 det]m9es t "o or m ( ! p]=mance b5*m>ks describ$ 9 subsection 7b7 are n be+ ma9ta9$1 ! cle>+h\se entity %all h #f mon?s f ! date ( issuance ( su* report to cure ! defici5cy4 7#d7 ,foll[-up report ,n lat] ?an #fj days aft] ! end ( ! #f-mon? corrective p]iod describ$ 9 p>agraph 7#c71 ! ,inspector ,g5]al %all issue a foll[-up public report evaluat+ :e!r ! defici5cy has be5 cur$ & :e!r ! applicable p]=mance b5*m>ks are be+ ma9ta9$4 7#e7 ,failure to ma9ta9 p]=mance b5*m>ks ,! obligation "u subsection 7a7 %all cease to apply if ! foll[-up report issu$ "u p>agraph 7#d7 det]m9es t ! defici5cy has n be5 cur$ or t "o or m ( ! applicable p]=mance b5*m>ks are n be+ ma9ta9$4 7d7 ,int]im p]=mance report ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all issue a prelim9>y public report1 validat$ by ! ,(fice ( ,inspector ,g5]al1 detail+ ! progress made t[>ds accompli%+ ! goals & /&>ds 9 subsection 7b74 ,! report %all include ! data1 me?odology1 & assumptions us$ by ! ,secret>y & id5tify any mat]ial op]ational1 data-quality1 or compliance b>ri]s affect+ a*ievem5t ( su* b5*m>ks4 7e7 ,special rule = select$ drugs ,not)/&+ subsection 7b7 & any o!r provision ( ?is section requir+ a cov]$ entity to submit data to ! ?ird-p>ty entity ) a contract 9 effect "u subsection 7f71 ) respect to a drug t is a select$ drug 7z def9$ 9 section #aaib7;c77-- 7#a7 ea* cov]$ entity %all transmit directly to ! manufactur]1 9 a timely mann] & 9 accordance ) /&>ds e/abli%$ by ! ,secret>y ?r\gh notice & comm5t rulemak+1 claims-level data suffici5t to enable ! manufactur] to prev5t duplicate disc\nts1 rebates1 or o!r ov]lapp+ price concessions & to validate compliance ) ! requirem5ts ( ?is section & section #aaia1 et seq42 & 7#b7 a cov]$ entity t fails to comply ) p>agraph 7#a7 %all1 foll[+ writt5 notice f ! ,secret>y id5tify+ ! specific failure & a #cj-;day p]iod to cure su* failure1 be subject to civil monet>y p5alties 9 an am\nt ( #e1jjj p] day dur+ ! p]iod ( su* non-compliance foll[+ ! expiration ( su* cure p]iod4 ,! provisions ( section #aabh;,a 7o!r ?an subsections 7a7 & 7b77 %all apply to a civil monet>y p5alty "u ?is section 9 ! same mann] z su* provisions apply to a p5alty or proce$+ "u section #aabh;,a7a74 7f7 ,cle>+h\se contract+ entity ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is section1 ! ,secret>y %all ent] into a contract ) an indep5d5t1 ?ird-p>ty cle>+h\se entity 7:o %all be free ( conflicts ( int]e/ ) cov]$ entities1 manufactur]s1 heal? plans1 ph>macy b5efit manag]s1 & ( o!r conflicts ( int]e/ z specifi$ by ! ,secret>y7 = purposes ( c>ry+ out ! cle>+h\se duties "u subsection 7g7 ) respect to ! drug disc\nt program "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act to facilitate robu/ & v]ifiable data ex*ange betwe5 relevant p>ties 9 ord] to improve program integrity "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act4 ,su* contract %all provide t ! ?ird-p>ty entity %all p]=m ! duties describ$ 9 subsection 7g7 & %all be = a #d-ye> t]m t may be r5ew$ aft] a subsequ5t bidd+ process or us+ competitive proc$ures1 z def9$ 9 section #acb ( title #da1 ,unit$ ,/ates ,code4 7g7 ,duties ,) respect to any #cdj;,b drug disp5s$ or adm9i/]$ to an individual1 )\t reg>d to ! individual's insurance /atus or ! type or s\rce ( paym5t = ! drug1 a ?ird-p>ty entity ) a contract 9 effect "u subsection 7f7 %all-- 7#a7 e/abli% a proc$ure = collect+ data elem5ts specifi$ 9 subp>agraph 7,a71 includ+ any additional data elem5ts requir$ by ! secret>y pursuant to subp>agraph 7,a77iv7 to improve program integrity ( ! drug disc\nt program "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act1 su* t-- 7,a7 ph>macy b5efit & m$ical b5efit claims-level data elem5ts report$ "u ?is section %all include ! data elem5ts specifi$ 9 clauses 7i7 ?r\gh 7iv7 ( ?is subp>agraph-- 7i7 ) respect to a ph>macy b5efit claim-- 7,i7 ! date ( s]vice2 7,,ii7 ! date on :i* ! drug 0 prescrib$2 7,,iii7 ! prescription numb]2 7,,iv7 ! fill numb]2 7,v7 ! #aa-;digit ,national ,drug ,code = ! drug disp5s$2 7,,vi7 ! quantity disp5s$2 7,,vii7 ! prescrib] id5tifi]2 7,,viii7 ! id5tifi] ( ! disp5s+ ph>macy or o!r s]vice provid]1 includ+ ! ,national ,provid] ,id5tifi]1 z applicable2 7,,ix7 ! #cdj;,b id5tification numb] ( ! cov]$ entity2 7,x7 ! prescription b5efit bank id5tification numb]2 & 7,,xi7 ! prescription b5efit processor control numb]2 7ii7 ) respect to a m$ical b5efit claim-- 7,i7 ! date ( s]vice2 7,,ii7 ! claim numb]2 7,,iii7 ! claim l9e numb]2 7,,iv7 ! quantity ( ! drug furni%$2 7,v7 ! unit ( measure2 7,,vi7 ! physician or o!r furni%+ provid] id5tifi]2 7,,vii7 ! applicable ,heal?c>e ,common ,proc$ure ,cod+ ,sy/em code & any applicable modifi]s2 7,,viii7 ! #aa-;digit ,national ,drug ,code = ! drug furni%$2 7,,ix7 ! ,national ,provid] ,id5tifi] ( ! bill+ provid]2 7,x7 ! #cdj;,b id5tification numb] ( ! cov]$ entity2 7,,xi7 ! heal? plan id5tifi]2 & 7,,xii7 ! "n ( ! heal? plan2 7iii7 ) respect to a ph>macy b5efit claim or m$ical b5efit claim describ$ 9 clause 7i7 or 7ii7-- 7,i7 ! "n ( ! :olesal]2 7,,ii7 ! :olesal] acc\nt numb]2 7,,iii7 ! invoice date2 7,,iv7 ! invoice numb]2 7,v7 ! ,national ,provid] ,id5tifi] ( ! ph>macy or o!r location to :i* ! drug 0 %ipp$2 7,,vi7 ! #aa-;digit ,national ,drug ,code = ! drug pur*as$2 7,,vii7 ! numb] ( package units pur*as$2 & 7,,viii7 ! #cdj;,b id5tification numb] ( ! cov]$ entity2 & 7iv7 su* additional data elem5ts z ! ,secret>y det]m9es necess>y to c>ry out ?is section to improve ! integrity ( ! drug disc\nt program "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act2 7,b7 claims-level data "u ?is section %all be submitt$ & mu/ be adjudicat$ )9 timeframes e/abli%$ by ! ,secret>y ?r\gh notice & comm5t rulemak+1 ) su* timeframes tak+ into acc\nt op]ational capabilities ( cov]$ entities2 & 7,c7 reclassification ( hi/orical claims by cov]$ entities f non-#cdj;,b to #cdj;,b beyond #f mon?s aft] ! drug is furni%$ is prohibit$1 except t ! ,secret>y may p]mit su* reclassification ^u a %[+ ( good cause by ! cov]$ entity2 7#b7 reque/ & receive1 9 ! mo/ effici5t & lea/ burd5some mann] practicable1 ) an e/abli%$ timeframe = su* report+-- 7,a7 claims-level rebate file data "u section #aibg1 f ,/ate ,m$icaid ag5cies2 7,b7 claims-level data f cov]$ entities &1 to ! ext5t necess>y1 contract ph>macies1 heal? plans1 entities provid+ ph>macy b5efit managem5t s]vices to heal? plans2 7,c7 claims-level rebate file data f comm]cially paid claims t are eligible "u ,section #cdj;,b2 & 7,d7 any o!r data specifi$ by ! ,secret>y z necess>y to c>ry out ?is section2 7#c7 reque/1 receive1 & ma9ta9 data describ$ 9 p>agraph 7#a7 9 a confid5tial mann]2 7#d7 ensure t claims-level data submissions by cov]$ entities are complete & accurate1 & if n1 obta9 complete & accurate data f ! cov]$ entity2 7#e7 notify ! cov]$ entity1 ! ,secret>y1 ! ,/ate ,m$icaid ag5cy1 & ! manufactur] ( any violation describ$ 9 section #cdj;,b7a77#e77;,a7 ( ! ,public ,heal? ,s]vice ,act to all[ = rem$iation2 7#f7 provide ! manufactur] ( a #cdj;,b drug ) claims-level data submitt$ by a cov]$ entity1 s t ! manufactur] may id5tify units ( a #cdj;,b drug t may g5]ate a rebate or disc\nt "u a volunt>y rebate or disc\nt arrangem5t1 su* z ^? relat$ to comm]cial plans2 7#g7 :]e feasible1 %>e ) a cov]$ entity1 ! ,secret>y1 a ,/ate ,m$icaid ag5cy1 & a manufactur]1 data ! ?ird-p>ty entity id5tifies 9 a timely mann] ) ! purpose ( prev5t+ any ( ! violations describ$ 9 section #bgbi;,a7b77#b7 ( ! ,public ,heal? ,s]vice ,act or duplicate disc\nts = a select$ drug "u section #ahdg;,a7i71 section #ahfj;,d-#ad;,b1 section #aaib2 7#h7 all[ cov]$ entities except ^? describ$ "u subp>agraph 7,l71 7,m71 7,n71 or 7,o7 ( section #cdj;,b7a77#d7 ( ! ,public ,heal? ,s]vice ,act ! option ( submitt+ claims-level data 9 a bat*$1 retrospective basis t does n require ! application ( modifi]s on individual claims or po9t-(-sale id5tification2 7#i7 det]m9e total sales ( #cdj;,b drugs to su* individuals = purposes ( be+ us$ z ! basis = det]m9+ us] fees "u section #cdj;,b7a77#ag7 ( su* ,act2 7#aj7 id5tify claims & provide manufactur] access to claims data = cov]$ outpati5t drugs pur*as$ "u ! drug disc\nt program "u ,section #cdj;,b ( ! ,public ,heal? ,s]vice ,act t-- 7,a7 are select$ drugs 7z def9$ 9 section #aaib7;c77 to enable manufactur]s to meet ! nonduplication requirem5ts ( section #aaic7;d72 7,b7 are subject to inflation rebates "u section #ahdg;,a7i7 or section #ahfj;,d-#ad;,b2 7,c7 = a rebate or disc\nt submitt$ by two or m cov]$ entities or *ild sites ) respect to ! same unit ( a cov]$ outpati5t drug pur*as$ "u ! drug disc\nt program2 or 7,d7 receiv$ reimbursem5t "u a ,/ate plan 7or waiv] ( su* plan7 & ensur+ su* claims are or 7 n includ$ 9 any ,/ate rebate reque/ "u section #aibg 9 violation ( sections #aijc7m77#b77;,a77xiii7 or #aibg7;j77#a7 or section #cdj;,b7a77#e77;,a7 ( ! ,public ,heal? ,s]vice ,act2 7#aa7 connect claims data & pur*as+ ord] data receiv$ "u ?is section 9 a /reaml9$1 timely1 & effici5t way2 7#ab7 provide access to ,/ate ,m$icaid ag5cies to data t is reasonably necess>y to prev5t duplicate disc\nts prohibit$ by section #cdj;,b7a77#e7 ( ! ,public ,heal? ,s]vice ,act2 7#ac7 e/abli% proc$ures = cov]$ entity report+ t may provide ! same function = ,/ate ,m$icaid ag5cies z cov]$ entity report+ to ,/ate ,m$icaid ag5cies2 7#ad7 respond to reque/s f cov]$ entities or manufactur]s )9 a numb] ( days e/abli%$ by ! ,secret>y ?r\gh notice & comm5t rulemak+2 7#ae7 facilitate manufactur] reasonable good fai? inquiries1 reasonable manufactur] audits1 duplicate-disc\nt reviews1 div]sion reviews1 & o!r program integrity activities "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act by receiv+1 validat+1 mat*+1 analyz+1 & produc+ claims-level data1 validation results1 or o!r outputs necess>y to resolve su* inquiries1 audits1 reviews1 or activities )9 timeframes e/abli%$ by ! ,secret>y ?r\gh notice & comm5t rulemak+1 z well z all /&>ds specifi$ by ! ,secret>y to be promulgat$ pursuant to section #aaej;,d7g77#af72 7#af7 e/abli%1 subject to /&>ds e/abli%$ by ! ,secret>y ?r\gh notice & comm5t rulemak+1 :i* /&>ds %all be consi/5t ) applicable law1 includ+ applicable ,f$]al & ,/ate data privacy & security laws & regulations 7includ+1 )\t limitation1 ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif & its implem5t+ regulations71 uni=m confid5tiality1 access1 use1 ret5tion1 & data-security t]ms applicable to in=mation submitt$ to1 ma9ta9$ by1 or transmitt$ ?r\gh ! cle>+h\se1 includ+ t]ms gov]n+ manufactur] access to & receipt ( claims-level data1 validation results1 or o!r outputs "u ?is section2 7#ag7 ensure t ! t]ms describ$ 9 p>agraph 7#af7 apply uni=mly to cov]$ entities1 manufactur]s1 heal? plans1 ph>macy b5efit manag]s1 & o!r p>ticipat+ entities & are n subject to individualiz$ negotiation z a condition ( submitt+ in=mation to1 receiv+ in=mation f1 or o!rwise p>ticipat+ 9 ! cle>+h\se process2 7#ah7 e/abli% proc$ures to docum5t any failure by a cov]$ entity to timely submit complete & accurate in=mation requir$ "u ?is section & to notify ! ,secret>y & any affect$ manufactur] ( su* failure2 & 7#ai7 ma9ta91 ) appropriate safegu>ds1 submitt$ data elem5ts = a p]iod ( #aj ye>s4 7h7 ,re/rictions on cle>+h\se contract+ entity ,! entity receiv+ a contract "u subsection 7f7 %all-- 7#a7 ensure t x has no conflicts ( int]e/1 includ+ no direct contractual involvem5t ) any cov]$ entity1 or manufactur] p>ticipat+ 9 ! drug disc\nt program "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act or any pay] t makes paym5ts = drugs pur*as$ ?r\gh su* program2 7#b7 n disclose confid5tial in=mation obta9$ ?r\gh c>ry+ out ! cle>+h\se duties "u ?is section o!r ?an z necess>y to c>ry out ! purposes ( ?is section1 includ+ = program integrity functions2 7#c7 n sell or o!rwise g5]ate rev5ue by lic5s+ or mak+ available ! data describ$ 9 subsection 7g77#a72 & 7#d7 n collect pric+ in=mation reg>d+ drugs t are n #cdj;,b drugs f cov]$ entities4 7i7 ,duties ( cov]$ entity 7#a7 ,9 g5]al ,cov]$ entities %all facilitate & p>ticipate 9 data transmission ) ! ?ird-p>ty cle>+h\se entity ) a contract 9 effect "u subsection 7f71 includ+ submission ( data elem5ts e/abli%$ by ! ,secret>y ?r\gh notice & comm5t rulemak+4 ,su* data transmission requirem5ts %all also apply ) respect to data relat+ to #cdj;,b drugs disp5s$ ?r\gh any ext]nal contract ph>macy arrangem5t1 & %all include data ma9ta9$ by or on behalf ( ! cov]$ entity by a contract ph>macy or ?ird-p>ty adm9i/rator4 7#b7 ,timely & complete submission ,a cov]$ entity %all timely submit complete & accurate in=mation requir$ "u ?is section to ! cle>+h\se contract+ entity 9 ! =m1 mann]1 & "t specifi$ by ! ,secret>y ?r\gh notice & comm5t rulemak+4 7#c7 ,failure to timely submit in=mation ,if a cov]$ entity fails to timely submit complete & accurate in=mation requir$ "u ?is section to ! cle>+h\se contract+ entity1 su* failure %all be treat$ z a failure to p>ticipate 9 ! cle>+h\se process & ! affect$ manufactur] %all provide writt5 notice to ! cov]$ entity & ! ,secret>y id5tify+ ! specific defici5cy4 ,if ! cov]$ entity does n cure su* failure )9 #cj days ( receipt ( su* notice1 ! affect$ manufactur] may susp5d ! availability ( disc\nts "u section #cdj;,b7a77#a7 ( ! ,public ,heal? ,s]vice ,act ) respect to su* cov]$ entity1 9 :ole or 9 "p1 until ! cov]$ entity cures su* failure4 7#d7 ,limitation on sep>ate confid5tiality t]ms ,a cov]$ entity may n condition1 delay1 or d5y submission ( in=mation to ! cle>+h\se contract+ entity1 or o!rwise condition1 delay1 or d5y p>ticipation 9 ! cle>+h\se process1 on ! execution or individualiz$ negotiation ( a confid5tiality agreem5t1 data use agreem5t1 or simil> agreem5t t is duplicative (1 inconsi/5t )1 or m re/rictive ?an ! uni=m confid5tiality1 access1 use1 ret5tion1 & data-security t]ms e/abli%$ by ! ,secret>y ?r\gh notice & comm5t rulemak+ "u ?is section4 7j7 ,re/rictions on manufactur] & pbm use ( data 7#a7 ,9 g5]al ,a manufactur] :o receives data "u subsection 7g7 may use su* data only = ! purpose ( prev5t+ duplicate disc\nts & div]sion "u section #cdj;,b7a77#e7 ( ! ,public ,heal? ,s]vice ,act1 prev5t+ duplicate disc\nts 9 connection ) inflation rebates "u section #ahdg7;,a77i7 & #ahfj;,d-#ad;,b z well z = select$ drugs 7z def9$ 9 section #aaib7;c77 to enable a manufactur] to meet ! nonduplication requirem5ts ( section #aaic7;d71 & validat+ compliance ) o!r requirem5ts "u ! drug disc\nt program "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act4 7#b7 ,re/rictions on plans1 issu]s1 & pbms ,a heal? plan1 ?ird p>ty adm9i/rator ( a heal? plan1 or entity provid+ ph>macy b5efit managem5t s]vices may use data receiv$ f ! cle>+h\se only = ! purpose ( prev5t+ duplicate disc\nts & div]sion "u ?is section4 7#c7 ,en=cem5t ,any manufactur] or o!r p]son f\nd by ! ,secret>y to h us$ data receiv$ "u subsection 7g7 = uses o!r ?an ^? describ$ 9 p>agraphs 7#a7 & 7#b71 su* z = pric+ or m>ket+1 %all be subject to civil monet>y p5alties1 e/abli%$ by ! ,secret>y ?r\gh notice & comm5t rulemak+4 7k7 ,privacy1 confid5tiality1 & data security requirem5ts 7#a7 ,9 g5]al ,! in=mation ex*ange requir$ "u ?is section %all occur pursuant to /&>ds e/abli%$ by ! ,secret>y ?r\gh notice & comm5t rulemak+1 includ+ uni=m confid5tiality1 access1 use1 ret5tion1 & data-security t]ms applicable to in=mation submitt$ to1 ma9ta9$ by1 or transmitt$ ?r\gh ! cle>+h\se contract+ entity1 includ+ t]ms gov]n+ manufactur] access to claims-level data1 validation results1 or o!r outputs "u ?is section1 & 9 a mann] consi/5t ) applicable ,f$]al & ,/ate data privacy1 security1 & brea* notification laws4 7#b7 ,purpose ( cle>+h\se ,! use ( ! cle>+h\se contract+ entity "u ?is section is int5d$ to facilitate secure ex*ange ( in=mation = #cdj;,b program integrity activities1 & ! cle>+h\se contract+ entity %all be requir$ to qualify z a cov]$ entity "u ! privacy1 security1 & brea* notification regulations promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif1 provid$1 h[ev]1 t no manufactur] %all be requir$ to qualify z a cov]$ entity or bus9ess associate "u ,,hipaa 9 ord] to obta9 & use data f ! cle>+h\se = only ! purposes id5tifi$ 9 ?is ,act4 7#c7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to-- 7,a7 limit1 n>r[1 or create any new precondition to ! disclosure ( claims-level1 utilization1 or o!r in=mation t may o!rwise be disclos$ "u applicable law = purposes ( #cdj;,b program integrity activities2 or 7,b7 require ! execution or individualiz$ negotiation ( a confid5tiality agreem5t1 data use agreem5t1 or simil> agreem5t n o!rwise requir$ by law z a condition ( disclos+1 submitt+1 receiv+1 ma9ta9+1 or us+ in=mation 9 accordance ) ?is section4 7l7 ,repaym5t to manufactur]s ,! ,secret>y %all1 e/abli% ?r\gh notice & comm5t rulemak+1 e/abli% a process to require cov]$ entities to "w ) affect$ manufactur]s reg>d+ id5tifi$ duplicate disc\nts & div]sion ( #cdj;,b drugs1 reg>dless ( ! me?od us$ to disp5se ! #cdj;,b drug1 :i* %all include repaym5t plus accru$ int]e/-- 7#a7 by ! cov]$ entity z a result ( ! cov]$ entity's noncompliance ) section #cdj;,b ( ! ,public ,heal? ,s]vice ,act2 or 7#b7 by a ,/ate ,m$icaid program ( rebates improp]ly reque/$ by ! ,/ate ,m$icaid program4 7m7 ,prohibit$ actions ( gr\p heal? plans & pbms 7#a7 ,9 g5]al ,a gr\p heal? plan1 a heal? insurance issu] (f]+ gr\p or individual cov]age 7z su* t]ms are def9$ 9 section #bgia ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#ia771 or an entity provid+ ph>macy b5efit managem5t s]vices may n int]f]e ) ! ability ( cov]$ entities1 contract ph>macies 7z su* t]ms are def9$ 9 section #cdj;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b771 or manufactur]s ( drugs to prev5t duplicate disc\nts or to rec\p ! full am\nt ( any id5tifi$ duplicate disc\nts pursuant to ! drug disc\nt program "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bed;b74 7#b7 ,en=cem5t ,! ,secret>y ( ,heal? & ,human ,s]vices %all impose civil monet>y p5alties on any gr\p heal? plan1 heal? insurance issu]1 or entity provid+ ph>macy b5efit managem5t s]vices t violates p>agraph 7#a74 7n7 ,/ate m$icaid ag5cies ,9 accordance ) requirem5ts e/abli%$ by ! ,secret>y ?r\gh notice & comm5t rulemak+1 ea* ,/ate's ag5cy responsible = ! adm9i/ration ( a ,/ate plan "u section #aijb7;a77#e7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#e77 %all e/abli% & publi% writt5 proc$ures t-- 7#a7 specify ! ext5t to :i* a #cdj;,b drug may be disp5s$ to a ,m$icaid b5efici>y1 includ+ b5efici>ies ( manag$ c>e programs2 7#b7 effectively id5tify :5 a #cdj;,b drug is disp5s$ to a ,m$icaid b5efici>y2 & 7#c7 exclude #cdj;,b drugs disp5s$ to ,m$icaid b5efici>ies f reque/s = rebates "u section #aibg4 7o7 ,def9itions ,9 ?is section3 7#a7 ,cov]$ entity ,! t]m cov]$ entity means an entity describ$ 9 section #cdj;,b7a77#d7 ( ! ,public ,heal? ,s]vice ,act4 7#b7 ,f$]al heal? c>e program ,! t]m ,f$]al heal? c>e program has ! mean+ giv5 t t]m 9 section #aabh;,b7f74 7#c7 ,heal? plans ,! t]m heal? plan has ! mean+ giv5 t t]m 9 section #aabh;,c7c74 7#d7 ,manufactur] ,! t]m manufactur] has ! mean+ giv5 t t]m 9 section #aibg7k77#e74 7#e7 #cdj;,b drug ,! t]m #cdj;,b drug means a drug t is-- 7,a7 a cov]$ outpati5t drug 7z def9$ = purposes ( section #cdj;,b ( ! ,public ,heal? ,s]vice ,act72 & 7,b7 pur*as$ "u an agreem5t 9 effect "u su* section4 7p7 ,ov]sight ,n lat] ?an #a ye> aft] implem5tation ( ! cle>+h\se1 ! ,secret>y %all3 7#a7 engage an indep5d5t auditor to conduct an annual audit ( ! cle>+h\se contract+ entity to ensure compliance ) ?is section1 includ+ b n limit$ to timely & accurate adjudication ( claims2 timely & complete transmission ( data to relevant p>ties2 & timely & sub/antive engagem5t ) cov]$ entities & manufactur]s1 :5 reque/$4 ,if ! ,secret>y f9ds ?r\gh ^! audits t ! cle>+h\se contract+ entity is n 9 compliance ) ?is section1 ! ,secret>y %all take appropriate action to ensure compliance1 :i* may include ! imposition ( civil monet>y p5alties aga9/ ! cle>+h\se contract+ entity1 or e>ly t]m9ation ( its contract1 provid$ ano!r compliant solution is available4 7#b7 issue a report to ,congress detail+ coord9at$ ef=ts1 includ+ ?r\gh ! use ( exi/+ res\rces to address reque/s f cov]$ entities 7z def9$ 9 section #cdj;,b7a77#d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77#d777 = paym5t "u title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 = m$ical assi/ance = a drug t is subject to an agreem5t "u section #cdj;,b7a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77 if ! drug is subject to ! paym5t ( a rebate to ! ,/ate "u section #aibg ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h71 z prohibit$ "u section #cdj;,b7a77#e77;,a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77#e77;,a771 & to prev5t ! duplicate disc\nts = cov]$ outpati5t drugs t are--select$ drugs 7z def9$ 9 section #aaib7;c7 ( ! ,social ,security ,act7 to enable manufactur]s to meet ! nonduplication requirem5ts ( section #aaic7;d7 ( su* ,act2 or subject to inflation rebates "u z def9$ by section #ahdg;,a7i7 or section #ahfj;,d-#ad;,b ( ! ,social ,security ,act4 7q7 ,regulations ,! ,secret>y ( ,heal? & ,human ,s]vices1 9 consultation ) ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices & ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration1 %all1 ?r\gh notice & comm5t rulemak+1 promulgate su* regulations z are necess>y to implem5t ! provisions ( ?is section1 advance ! purpose ( ! drug disc\nt program "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7 & prev5t duplicate disc\nts & div]sion ?r\gh ! cle>+h\se e/abli%$ by ! am5dm5t made by ?is section4 4 #i4 ,prohibition on discrim9atory practices & contract+ 7a7 ,9 g5]al ,"p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg et seq47 is am5d$ by ins]t+ aft] section #bgbi 7#db ,u4,s4,c4 #cjj;gg-#ai;b7 ! foll[+3 #bgcj4 ,anti-discrim9ation & p]missible #cdj;b arrangem5ts 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] may n discrim9ate aga9/ a cov]$ entity 7z def9$ 9 section #cdj;,b7a77#d77 or a contract ph>macy 7z def9$ 9 section #cdj;,b7b77#e771 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 cov]$ outpati5t drugs 7z def9$ 9 section #aibg7k7 ( ! ,social ,security ,act71 includ+ 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] may n discrim9ate aga9/ a cov]$ entity1 a contract ph>macy1 or a p>ticipant or b5efici>y 9 a gr\p heal? plan or heal? insurance (f]$ by a heal? insurance issu] (f]+ gr\p or individual heal? insurance by do+ any ( ! foll[+3 7#a7 ,reimburs+ a cov]$ entity or contract ph>macy = a quantity ( a cov]$ outpati5t drug pur*as$ "u section #cdj;,b 9 an am\nt less ?an su* plan1 issu]1 or ph>macy b5efit manag]1 z applicable1 w\ld pay to any o!r simil>ly situat$ 7z specifi$ by ! ,secret>y ?r\gh notice & comm5t rulemak+7 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 cov]$ outpati5t drugs pur*as$ "u section #cdj;,b4 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 cov]$ outpati5t drugs pur*as$ "u ?is section-- 7,a7 fees1 *>gebacks1 clawbacks1 adju/m5ts1 or o!r assessm5ts2 7,b7 pr(essional disp5s+ fees2 7,c7 re/rictions or requirem5ts reg>d+ p>ticipation 9 /&>d or pref]r$ ph>macy networks2 7,d7 requirem5ts relat+ to ! frequ5cy or scope ( audits or to inv5tory managem5t sy/ems us+ g5]ally accept$ acc\nt+ pr9ciples2 or 7,e7 any o!r re/rictions1 conditions1 practices1 or policies t1 z specifi$ by ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration ?r\gh notice & comm5t rulemak+1 int]f]e ) ! ability ( a cov]$ entity to maximize ! value ( disc\nts provid$ "u section #cdj;,b4 7#c7 ,int]f]+ ) an individual's *oice to receive a drug pur*as$ "u ,section #cdj;,b f a cov]$ entity or contract ph>macy1 :e!r 9 p]son or via direct deliv]y1 mail1 or o!r =m ( %ipm5t4 7#d7 ,requir+ a cov]$ entity or specifi$ ph>macy to id5tify1 ei!r directly or ?r\gh a ?ird p>ty1 cov]$ outpati5t drug pur*as$ "u ! #cdj;,b program4 ,o!r ?an ?r\gh ! #cdj;,b ,data ,cle>+h\se e/abli%$ at section #aaej;,d4 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 ! cov]$ entity is describ$ 9 section #cdj;,b7a77#d74 7#f7 ,d5y+ cov]age ( a cov]$ outpati5t drug pur*as$ "u ! #cdj;,b program on ! basis ( its /atus z a #cdj;,b eligible drug if ! gr\p heal? plan or heal? insurance issu] o!rwise cov]s ! id5tical drug n pur*as$ "u #cdj;,b4 7c7 ,prohibition ,a gr\p heal? plan1 a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age1 or a ph>macy b5efit manag] may n ent] into a contract or o!r agreem5t1 or any o!r arrangem5t reg>dless ( :e!r su* arrangem5t is memorializ$ 9 writ+1 ) a cov]$ entity 7z def9$ 9 section #cdj;,b7a77#d77 9 :i* ! cov]$ entity provides a %>e ( any disc\nt or sav+s = a cov]$ outpati5t drug "u section #cdj;,b to ! gr\p heal? plan1 heal? insurance issu]1 or ph>macy b5efit manag]1 & may n condition network p>ticipation1 pref]r$ =mul>y placem5t1 claim r\t+1 or any o!r b5efit on ! cov]$ entity's agreem5t to %>e any su* disc\nt or sav+s4 7d7 ,en=cem5t me*anism ,! ,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 4 7b7 ,,ssa ,section #ahfj;,d7#ab7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7i7 ,nondiscrim9ation ,,pdp sponsors may n include any provision 9 a prescription drug plan t requires cov]$ entities "u ,section #cdj;,b ( ! ,public ,heal? ,s]vice ,act to make use ( contract ph>macy sites t d n meet ! requirem5ts set =? 9 ,section #cdj;,b = ! use ( contract ph>macies or are o!rwise inconsi/5t ) pati5t ne$ & access4 4 7c7 #cdj;,b ,section #cdj;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b71 z am5d$1 is am5d$ by add+ at ! end ! foll[+ new subsection3 7i7 ,p]mitt$ ?ird p>ty adm9i/rator arrangem5ts 7#a7 ,a cov]$ entity "u ?is section may only contract ) a ?ird-p>ty adm9i/rator = ! purposes ( adm9i/]+ ! disp5s+ ( cov]$ drugs "u ?is section if comp5sation = ! ?ird-p>ty adm9i/rator is 9 ! =m ( bona fide s]vices fees4 7#b7 ,bona fide s]vice fees z describ$ 9 p>agraph 7#a7 may n be det]m9$ z a p]c5tage ( rev5ue to ! cov]$ entity = cov]$ drugs "u ?is section or by any o!r metric ti$ to rev5ue = cov]$ drugs to ! cov]$ entity or volume ( cov]$ drugs disp5s$ by ! cov]$ entity4 7#c7 ,,hrsa may1 pursuant to /&>ds e/abli%$ ?r\gh notice & comm5t rulemak+1 levy ,civil ,monet>y ,p5alties ^u cov]$ entities = kn[+ & int5tional non-compliance ) requirem5ts "u p>agraphs 7#a7 & 7#b74 4 7d7 ,con=m+ am5dm5ts 7#a7 ,employee retirem5t income security act 7erisa7 ,section #gae7;a77#a7 ( ,,erisa 7#bi ,u4,s4,c4 #aahe;d7a77#a77 is am5d$ by ins]t+ & subsequ5t legislation aft] z am5d$ by ! ,pati5t ,protection & ,af=dable ,c>e ,act4 7#b7 ,int]nal rev5ue code ,section #ihae7;a77#a7 ( ! ,int]nal ,rev5ue ,code ( #aihf 7#bf ,u4,s4,c4 #ihae7;a77#a77 is am5d$ by ins]t+ & subsequ5t legislation aft] z am5d$ by ! ,pati5t ,protection & ,af=dable ,c>e ,act4 #aj4 ,ensur+ ,,hrsa has adequate res\rces to ov]see ! program 7a7 ,9 g5]al ,section #cdj;,b7a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a771 z am5d$ by ! prec$+ sections1 is fur!r am5d$ by add+ at ! end ! foll[+3 7#ag7 ,us] fee program 7,a7 ,9 g5]al ,beg9n+ 9 fiscal ye> #bjbg1 ! ,secret>y %all assess & collect fees f cov]$ entities p>ticipat+ 9 ! program "u ?is section1 9 accordance ) ?is p>agraph4 7,b7 ,fee am\nts ,! fees describ$ 9 subp>agraph 7,a7 %all be assess$ & collect$ f ea* cov]$ entity on an annual basis1 9 an am\nt det]m9$ by ! ,secret>y ?r\gh proc$ures e/abli%$ ?r\gh notice & comm5t rulemak+4 ,9 g5]al1 ! fee %all be #j4a p]c5t ( ! doll> am\nt paid by ! cov]$ entity = cov]$ outpati5t drugs "u ?is section 9 ! previ\s ye>4 7,c7 ,use ( fees ,any fees collect$ "u ?is p>agraph f cov]$ entities %all be us$ by ! ,secret>y = purposes ( adm9i/]+ ?is section & enhanc+ program integrity & ov]sight activities "u ?is section1 includ+-- 7i7 ! developm5t ( a multi-functional web-bas$ sy/em to collect fees "u ?is p>agraph2 7ii7 ! e/abli%m5t1 use1 & ma9t5ance ( ! data cle>+h\se "u section #aaej;,d ( ! ,social ,security ,act2 7iii7 ! improvem5t ( ! integrity1 transp>5cy1 security1 se>*ability1 & reliability ( ! #cdj;,b ,(fice ( ,ph>macy ,affairs ,in=mation ,sy/em 7or a successor to su* sy/em71 includ+ to ensure t su* sy/em cont9ues to meet ! ne$s ( ext]nal /akehold]s2 7iv7 improvem5ts to ! compliance tool us$ to integrate all in=mation relat$ to manufactur]s t h ent]$ into agreem5ts ) ! ,secret>y "u p>agraph 7#a7 & cov]$ entities2 7v7 audits "u ?is section ( cov]$ entities & su* manufactur]s2 & 7vi7 any o!r uses = ! purposes ( program integrity1 z ! ,secret>y det]m9es appropriate4 7,d7 ,supplem5t n supplant ,any fees collect$ "u ?is p>agraph %all be us$ to supplem5t & n supplant am\nts o!rwise provid$ 9 appropriations ,acts to c>ry out ?is section4 7,e7 ,regulations ,! ,secret>y %all promulgate regulations z necess>y to implem5t ! us] fee program "u ?is p>agraph1 :i* %all include e/abli%m5t ( a process to provide = exceptions to ! fee am\nt "u subp>agraph 7,b71 includ+ ! circum/ances "u :i* su* exceptions may apply to c]ta9 cov]$ entities4 7,f7 ,ov]sight ( us] fee program ,! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all-- 7i7 conduct an annual review ( ! us] fee program "u ?is p>agraph = ! fir/ #e ye>s ( su* program2 & 7ii7 n lat] ?an ,septemb] #cj ( ea* ye> = :i* a review is requir$ "u clause 7i71 submit to ,congress a report on ! review conduct$ "u clause 7i71 toge!r ) su* recomm5dations z ! ,inspector ,g5]al det]m9es appropriate4 4 7b7 ,con=m+ am5dm5t ,section #cdj;,b7a77#d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77#d77 is am5d$1 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ 1 has submitt$ us] fees to ! ,secret>y 9 ! am\nt assess$ "u p>agraph 7#ag7 = ! curr5t ye>1 aft] p>agraph 7#e74 ,section #cdj;,b7a77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77#a77 is fur!r am5d$ by ins]t+ 1 & has submitt$ us] fees to ! ,secret>y 9 ! am\nt assess$ "u p>agraph 7#ag7 = ! curr5t ye>1 aft] ! fir/ ref]5ce to agreem5t 9 su* p>agraph4 7c7 ,fund+ ,section #cdj;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7j7 ,au?orizations ( appropriations 7#a7 ,au?orization ( appropriations = audits1 inve/igations1 & o!r ov]sight & en=cem5t activities ,9 addition to am\nts made available "u subsection 7d77#d71 !re are au?oriz$ to be appropriat$ #c1jjj1jjj = ea* ( fiscal ye>s #bjbg ?r\gh #bjca1 = purposes ( conduct+ audits1 inve/igations1 & o!r ov]sight & en=cem5t activities ) respect to ! drug disc\nt program "u ?is section1 includ+ audits ( cov]$ entities & manufactur]s4 7#b7 ,au?orization ( appropriation = g5]al purposes ,9 addition to am\nts made available "u p>agraph 7#a7 & subsection 7d77#d71 !re are au?oriz$ to be appropriat$ #i1jjj1jjj = ea* ( fiscal ye>s #bjbh ?r\gh #bjca1 = purposes ( implem5t+ ! activities "u ?is section1 includ+ audits ( cov]$ entities & manufactur]s4 4 7d7 ,direct hire au?ority ,section #cdj;,b7d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7d77 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#f7 ,direct-hire au?ority ,not)/&+ section #ccjd7;a77#c7 ( title #e1 ,unit$ ,/ates ,code1 & sections #ccji ?r\gh #ccah ( su* title1 & section #ccg ( title #e ( ! ,code ( ,f$]al ,regulations 7or any successor regulations71 ! ,secret>y may1 beg9n+ on ! date ( ! enactm5t ( ?is p>agraph1 ex]cise direct-hire au?ority to appo9t a m9imum ( tw5ty qualifi$ c&idates to p]man5t positions )9 ! competitive s]vice 9 ord] to c>ry out managem5t & ov]sight activities "u ?is section1 ) respect to cov]$ entities & manufactur]s p>ticipat+ 9 ! drug disc\nt program "u ?is section4 4 #aa4 ,/udies & reports 7a7 ,co/ ( disp5s+ /udies & report 7#a7 ,/udy ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is section1 ! ,secret>y %all conduct a /udy on disp5s+ fees & reimbursem5ts t heal? plans & ph>macy b5efit manag]s pay to ph>macies1 sep>at$ by ea* category ( pay] 7at a m9imum1 ,m$ic>e1 ,m$icaid1 & comm]cial payors7 & :e!r ! drug is pur*as$ "u section #cdj;,b4 ,! ,secret>y %all repeat ?is /udy n less ?an e #bd mon?s !reaft]4 7#b7 ,report ,n lat] ?an #ij days aft] ! completion ( ea* /udy conduct$ "u p>agraph 7#a71 ! ,secret>y %all submit to ,congress a report conta9+ ! results ( su* /udy1 includ+-- 7,a7 ! am\nt ( disp5s+ fees = cov]$ outpati5t drugs pur*as$ "u section #cdj;,b & cov]$ outpati5t drugs n pur*as$ "u section #cdj;,b2 7,b7 :e!r su* fees are reasonable2 & 7,c7 any recomm5dations = fur!r ,congressional action ) respect to disp5s+ fees & ! e/abli%m5t ( acceptable /&>ds = disp5s+ fees4 7b7 ,comptroll] g5]al /udy & report on #cdj;,b disc\nt 7#a7 ,/udy ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is section1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy ( ! #cdj;,b disc\nt 7! unit rebate am\nt ref]5c$ 9 section #cdj;,b7a77#a7 ( ! ,public ,heal? ,s]vice ,act7 t is reta9$ by-- 7,a7 contract ph>macies2 7,b7 heal? plans2 7,c7 ph>macy b5efit manag]s2 7,d7 ?ird-p>ty v5dors2 7,e7 pati5ts2 & 7,f7 cov]$ entities4 7#b7 ,report ,n lat] ?an #b ye>s aft] enactm5t1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report detail+ ! results ( ?is /udy4 7,a7 ,in=mation %all be aggregat$ = ea* type ( cov]$ entity1 & by arrangem5ts ! cov]$ entity has ) ea* diff]5t entity specifi$ 9 subp>agraphs 7,a7 ?r\gh 7,d7 ( p>agraph 7#a71 describ+ ! am\nt ( ! #cdj;,b disc\nt reta9$ by ! cov]$ entity & ! entities specifi$ 9 subp>agraphs 7,a7 ?r\gh 7,d7 ( p>agraph 7#a74 7,b7 ,! report %all include recomm5dations to ,congress on a /&>diz$ set ( def9itions to collect ?is in=mation & a calculation me?odology4 7c7 ,,gao report ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a report on ! debt collection practices ( hospitals1 includ+ hospitals t p>ticipate 9 ! drug disc\nt program "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7 z cov]$ entities describ$ 9 subp>agraphs 7,l7 ?r\gh 7,o7 ( subsection 7a77#d7( su* section4 7d7 ,reports to congress 7#a7 ,initial report ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is subsection1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit a report to ,congress on ! foll[+3 7,a7 analyz+ su* contracts betwe5 ,/ate & local gov]nm5ts & cov]$ entities describ$ 9 subp>agraph 7,l71 7,m71 7,n71 or 7,o7 ( subsection 7a77#d7 t claim to be eligible = ! drug disc\nt program "u ?is section by virtue ( be+ a private non-pr(it hospital t has a contract ) a ,/ate or local gov]nm5t to provide heal? c>e s]vices to l[-income individuals :o are n eligible = ,m$icaid or ,m$ic>e2 7,b7 assess+ ! am\nt ( c>e ! contracts describ$ 9 subp>agraph 7,a7 obligate ! cov]$ entity to provide to individuals at or bel[ #djj p]c5t ( ! ,f$]al ,pov]ty ,level1 :o are ineligible = ,m$ic>e "u title ,,xviii ( ! ,social ,security ,act & ,m$icaid "u title ,,xix ( su* ,act2 7,c7 assess+ ! am\nt ( *>ity c>e & uncomp5sat$ c>e cov]$ entities report+ "u ?is section provide to individuals e>n+ at or bel[ #djj p]c5t ( ! ,f$]al ,pov]ty ,level2 7,d7 analyz+ ! diff]5ce betwe5 ! aggregate gross reimbursem5t & aggregate acquisition co/s receiv$ by ea* cov]$ entity = cov]$ outpati5t drugs pur*as$ "u ! #cdj;,b program2 7,e7 analyz+ ! degree to :i* ,f$]ally ,qualifi$ ,heal? ,c5t]s1 z su* t]m is def9$ 9 subsection 7a77#d77;,a71 are subject to ! violations "u section #bgcj7;b7 ( ! ,public ,heal? ,s]vice ,act1 & ! effect ( ^! violations on ,f$]ally ,qualifi$ ,heal? ,c5t]s' ability to provide af=dable c>e to und]s]v$ populations2 & 7,f7 analyz+ h[ ! contracts describ$ 9 subp>agraph 7,a7 def9e l[-income individuals & :e!r ! ,secret>y reviews su* det]m9ations4 7#b7 ,subsequ5t report ,n lat] ?an #b ye>s aft] ! date ( ! enactm5t ( ?is subsection1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ,congress a f9al report on ! in=mation collect$ "u p>agraph 7#a7 reg>d+ ! diff]5ce betwe5 ! aggregate paym5t receiv$ by ea* su* cov]$ entity 7includ+ *ild sites ( su* entity & add+ in=mation on all s\rces ( paym5t receiv$ by ! cov]$ entity & its *ild sites7 = drugs pur*as$ "u ?is section & ! aggregate co/s paid by ! cov]$ entity 7includ+ its *ild sites7 to acquire su* drugs4 7#c7 ,cl>ification ,:5 submitt+ ^! reports1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all n provide copies ( unr$act$ contracts or any "w mat]ials to ,congress or any o!r p>ties4 #ab4 ,mean+s ,section #cdj;,b7b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7b771 z am5d$ by ! prec$+ sections1 is fur!r am5d$ by add+ at ! end ! foll[+3 7#d7 ,*ild site ,9 ?is section1 ! t]m *ild site means any outpati5t dep>tm5t1 cl9ic1 or facility t is sep>ately regi/]$ "u ?is section z an outpati5t facility ( a cov]$ entity describ$ 9 subp>agraph 7,l71 7,m71 7,n71 or 7,o7 ( subsection 7a77#d7 & t is n itself ! cov]$ entity's pr9cipal op]at+ location or ! location ?r\gh :i* ! cov]$ entity satisfies ! requirem5ts = eligibility "u subsection 7a77#d74 7#e7 ,contract ph>macy ,9 ?is section1 ! t]m contract ph>macy means a ph>macy t1 pursuant to a contract or o!r arrangem5t ) a cov]$ entity1 disp5se or o!rwise furni%es cov]$ outpati5t drugs to pati5ts on behalf ( ! cov]$ entity1 :e!r 9 p]son1 by mail1 or ?r\gh any o!r deliv]y me?od4 4 #ac4 ,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,f7 ,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 ?r\gh notice & comm5t rulemak+ 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 #ad4 ,effective date 7a7 ,9 g5]al ,except z o!rwise expressly provid$ 9 ?is ,act1 ! am5dm5ts made by ?is ,act %all take effect on ! date ( enactm5t ( ?is ,act4 7b7 ,regulations2 transition p]iod 7#a7 ,regulations ,n lat] ?an #ahj days aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all1 ?r\gh notice & comm5t rulemak+1 promulgate su* f9al regulations z are necess>y to implem5t ?is ,act & ! am5dm5ts made by ?is ,act1 includ+ any su* regulations requir$ else:]e 9 ?is ,act or 9 am5dm5ts made by ?is ,act4 7#b7 ,transition p]iod ,9 promulgat+ ! regulations requir$ "u p>agraph 7#a71 ! ,secret>y %all e/abli% appropriate transition p]iods = cov]$ entities1 manufactur]s1 contract ph>macies1 & o!r affect$ p>ties to come into compliance ) ! requirem5ts impos$ by ?is ,act & ! am5dm5ts made by ?is ,act4 ,su* transition p]iods %all n be less ?an #ahj days f ! date ( enactm5t = any sub/antive new compliance obligation impos$ on a cov]$ entity or manufactur] by ?is ,act1 unless a long] or %ort] transition p]iod is specifically provid$ else:]e 9 ?is ,act4 7c7 ,con/ruction ,any ref]5ce 9 ?is ,act to ! date ( enactm5t ( ?is section %all be con/ru$ z ref]r+ to ! date ( enactm5t ( ?is ,act unless ! context cle>ly requires o!rwise4