,,ii #aai? ,,congress #b;d ,session ,s4 #ebdd ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,augu/ #e1 #bjbf,mr4 ,moran 7= himself1 ,ms4 ,baldw91 ,mrs4 ,capito1 ,mr4 ,ka9e1 ,mr4 ,boozman1 & ,mr4 ,hick5loop]7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to am5d ! ,public ,heal? ,s]vice ,act ) respect to ! drug disc\nt program1 & = o!r purposes4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,support+ ,und]s]v$ & ,/r5g!n+ ,transp>5cy1 ,acc\ntability1 & ,integrity ,n[ & = ! ,future ( #cdj;,b ,act or ! ,,su/a9 #cdj;,b ,act4 7b7 ,table ( cont5ts ,! table ( cont5ts = ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4,sec4 #b4 ,s5se ( ,congress4,sec4 #c4 ,contract ph>macy4,sec4 #d4 ,pati5t def9ition4,sec4 #e4 #cdj;,b ,rebate ,model ,pilot ,program sunset4,sec4 #f4 ,*ild sites4,sec4 #g4 ,transp>5cy4,sec4 #h4 ,enhanc+ program integrity4,sec4 #i4 ,prev5t+ duplicate disc\nts4,sec4 #aj4 ,pati5t f9ancial assi/ance4,sec4 #aa4 ,ensur+ ! equitable treatm5t ( cov]$ entities & ph>macies p>ticipat+ 9 ! #cdj;,b drug disc\nt program4,sec4 #ab4 ,us] fee program4,sec4 #ac4 ,/udies & reports4,sec4 #ad4 ,additional res\rces4,sec4 #ae4 ,def9itions4,sec4 #af4 ,effective date4 #b4 ,s5se ( ,congress ,x is ! s5se ( ,congress t ! purpose ( ! drug disc\nt program "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7 is to /ret* sc>ce ,f$]al res\rces & help safety net provid]s ma9ta91 improve1 & exp& pati5t access to heal? c>e s]vices by requir+ drug manufactur]s1 z a condition ( p>ticipation 9 ! ,m$icaid program "u title ,,xix ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq47 & ! ,m$ic>e program "u "p ,b ( title ,,xviii ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acie;j et seq471 to provide disc\nts at ! po9t ( pur*ase to cov]$ entities t s]ve a disproportionate %>e ( l[-income & und]s]v$ pati5ts or m$ically vuln]able pati5ts4 #c4 ,contract ph>macy 7a7 ,use ( contract ph>macies ,section #cdj;,b7a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77 is am5d$ by add+ at ! end ! foll[+3 7#aa7 ,contract ph>macies 7,a7 ,9 g5]al ,a cov]$ entity may elect to use "o or m :olly-own$ ph>macies1 9 addition to "o or m contract ph>macies1 to acquire & disp5se to pati5ts ( ! cov]$ entity cov]$ outpati5t drugs pur*as$ by ! cov]$ entity pursuant to an agreem5t describ$ 9 p>agraph 7#a74 7,b7 ,limits on c]ta9 contract ph>macies 7i7 ,9 g5]al ,subject to clause 7ii71 ea* cov]$ entity t elects to use "o or m contract ph>macies to disp5se cov]$ outpati5t drugs pur*as$ by ! cov]$ entity pursuant to an agreem5t describ$ 9 p>agraph 7#a7 to pati5ts ( ! cov]$ entity %all cancel ! contract ) any su* ph>macy t has n disp5s$ any cov]$ outpati5t drugs to su* pati5ts 9 ! mo/ rec5t #ab-mon? p]iod4 7ii7 ,exceptions ,a cov]$ entity is n requir$ to cancel ! contract ( a ph>macy t has n disp5s$ cov]$ outpati5t drugs 9 ! mo/ rec5t #ab-mon? p]iod1 z describ$ 9 clause 7i71 if-- 7,i7 !re is a *ange ( own]%ip ( ! cov]$ entity or ph>macy requir+ a new contract to cont9ue an e/abli%$ arrangem5t2 7,,ii7 !re is a *ange to ! cov]$ entity's s]vice area2 7,,iii7 ! contract ph>macy is necess>y = ! cov]$ entity to pres]ve access = em]g5cy or cont+5cy use2 or 7,,iv7 o!r circum/ances exi/1 z ! ,secret>y may det]m9e appropriate4 7iii7 ,?re%old = high numb] ( contract ph>macies ,! ,secret>y may develop a process t is n ov]ly burd5some to ! cov]$ entities to increase audits on cov]$ entities t use a high numb] ( contract ph>macies1 z det]m9$ by ! ,secret>y4 7,c7 ,regi/ration ( contract ,a cov]$ entity %all regi/] ) ! ,secret>y1 & annually rec]tify1 any contract = a contract ph>macy arrangem5t1 9 accordance ) su* regi/ration requirem5ts z ! ,secret>y may e/abli% ?r\gh regulations4 ,su* regi/ration requirem5ts %all include requir+ ! cov]$ entity to d ea* ( ! foll[+3 7i7 ,submit all contract ph>macy agreem5ts to ! ,secret>y 9 a timely mann]1 prior to implem5t+ ! contract ph>macy agreem5t4 7ii7 ,regi/] ea* contract ph>macy arrangem5t ) ! ,secret>y prior to implem5t+ ! contract ph>macy agreem5t4 7iii7 ,atte/ to ! cov]$ entity's compliance ) ! requirem5ts "u ?is section4 7,d7 ,contract review process ,! ,secret>y %all e/abli% a process to review writt5 agreem5ts betwe5 a cov]$ entity & ea* ( its contract ph>macies describ$ 9 subp>agraph 7,e77i71 to ensure compliance ) ! requirem5ts "u ?is subsection4 7,e7 ,improvem5ts 9 contract ph>macy arrangem5t integrity ,to ensure ! integrity ( contract ph>macy arrangem5ts describ$ 9 ?is p>agraph1 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 & "o or m contract ph>macies ( ! cov]$ entity4 ,ea* su* agreem5t %all-- 7,i7 li/ ! address ( ea* contract ph>macy location t w disp5se drugs on behalf ( ! cov]$ entity or ref]5ce ! li/ ( su* cov]$ entity sites t are active sites 9 ! #cdj;,b ,(fice ( ,ph>macy ,affairs ,in=mation ,sy/em 7or a successor to su* sy/em72 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 ! contract ph>macy is requir$ to provide ph>macy s]vices2 7,,ii7 ! contract ph>macy is requir$ to provide data to ! cov]$ entity to support ! submission by ! cov]$ entity ( cov]$ outpati5t data to a cle>+h\se contract$ entity describ$ 9 section #aaej;,d7a7 ( ! ,social ,security ,act2 7,,iii7 nei!r ! contract ph>macy nor ! cov]$ entity w require a pati5t to use a c]ta9 ph>macy or to obta9 a prescription f ! cov]$ entity1 or o!rwise int]f]e ) pati5t *oice ( a ph>macy provid]1 except 9 ! case ( a cov]$ entity p>ticipat+ 9 ! program "u section #bfaf2 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 or 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 ! 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 or receiv+ & disp5s+ records2 7,,vii7 ! cov]$ entity & ! contract ph>macy w develop & implem5t a sy/em to v]ify eligibility ( pati5ts1 9 accordance ) subsection 7b77#c71 & w e/abli% & ma9ta9 safegu>ds to prev5t div]sion ( cov]$ outpati5t drugs2 7,,viii7 ! 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$icaid ag5cy h e/abli%$ an arrangem5t to prev5t duplicate disc\nts1 consi/5t ) p>agraph 7#e77;,a71 & su* arrangem5t is report$ to ! ,secret>y2 7,,ix7 ! contract ph>macy agrees to be subject to annual indep5d5t audits commission$ by ! cov]$ entity2 & 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 prohibition4 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+ ! practices & proc$ures = contract ph>macy ov]sight1 includ+ ! scope & frequ5cy ( su* ov]sight4 7v7 ,e/abli% a ret5tion p]iod ( at lea/ #c ye>s dur+ :i* cov]$ 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 describ$ 9 p>agraph 7#e74 4 7b7 ,manufactur] requirem5ts ,section #cdj;,b7a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a771 z am5d$ by subsection 7a71 is fur!r am5d$ by add+ at ! end ! foll[+3 7#ab7 ,manufactur] requirem5ts ,a manufactur] ( a cov]$ outpati5t drug t is subject to an agreem5t ) ! ,secret>y "u p>agraph 7#a7 %all1 z a condition ( su* agreem5t1 comply ) ! foll[+ requirem5ts3 7,a7 ,(f] ! 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 ?r\gh a contract ph>macy ( ! cov]$ entity4 7,b7 ,deliv] or all[ ! deliv]y ( cov]$ outpati5t drugs pur*as$ by a cov]$ entity at or bel[ ! applicable ceil+ price describ$ 9 p>agraph 7#a7 to locations1 includ+ ph>macy locations z reque/$ by a cov]$ entity1 9 accordance ) ! cov]$ entity's contract ph>macy agreem5ts4 7,c7 ,n1 directly or indirectly1 place any ( ! foll[+ conditions on ! (f]s made to 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 ! applicable writt5 contract ph>macy arrangem5ts3 7i7 ,re/rict+ di/ribution options only ) respect to cov]$ outpati5t drugs1 cov]$ entities1 or contract ph>macies4 7ii7 ,requir+ ! submission ( claims data to ! manufactur]1 except = submissions to ! entity receiv+ ! contract to ma9ta9 ! cle>+h\se "u section #aaej;,d ( ! ,social ,security ,act4 7iii7 ,su* o!r conditions z ! ,secret>y may prohibit ?r\gh notice & comm5t rulemak+4 4 7c7 ,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$-- 7#a7 by /rik+ int5tionally *>ges & ins]t+ ! foll[+3 8int5tionally-- 7aa7 *>ges 2 7#b7 by /rik+ ! p]iod & ins]t+ a semicolon2 & 7#c7 by add+ at ! end ! foll[+3 7bb7 refuses to (f] a cov]$ outpati5t drug = pur*ase at or bel[ ! ceil+ price2 7cc7 refuses to deliv] a cov]$ outpati5t drug pur*as$ by a cov]$ entity at or bel[ ! ceil+ price2 or 7dd7 places conditions on ! ability ( a cov]$ entity to pur*ase a cov]$ outpati5t drug at or bel[ ! ceil+ price4 4 7d7 ,transp>5cy ,p>agraph 7#aa7 ( section #cdj;,b7a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a771 z add$ by subsection 7a71 is am5d$ by add+ at ! end ! foll[+3 7,f7 ,transp>5cy ,ea* cov]$ entity t uses "o or m contract ph>macies z describ$ 9 ?is p>agraph %all make ! foll[+ in=mation ab\t ea* contract ph>macy arrangem5t pursuant to ?is p>agraph & regi/]$ "u subp>agraph 7,c7 available to ! ,secret>y = publication on ! website ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices3 7i7 ,! "n ( ! cov]$ entity1 includ+ ea* *ild site1 t uses a contract ph>macy4 7ii7 ,! "n & address ( ea* contract ph>macy location to :i* ! contract ph>macy arrangem5t applies4 7iii7 ,! effective date ( ! contract ph>macy arrangem5t4 7iv7 ,! la/ ye> a cov]$ outpati5t drug 0 disp5s$ "u ! contract ph>macy arrangem5t f ea* location4 7v7 ,! numb] ( cov]$ outpati5t drugs disp5s$ annually f ea* location "u ?is section4 7vi7 ,:e!r ! contract ph>macy is a mail-ord] or pay]-m&at$ ph>macy4 4 7e7 ,audit+ ,section #cdj;,b7a77#e77;,c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77#e77;,c77 is am5d$-- 7#a7 by /rik+ ,a cov]$ entity & ins]t+ ! foll[+3 7i7 ,9 g5]al ,a cov]$ entity 2 & 7#b7 by add+ at ! end ! foll[+3 7ii7 ,contract ph>macy audits 7,i7 ,9 g5]al ,a cov]$ entity t uses "o or m contract ph>macies %all p]mit ! ,secret>y or ! manufactur] ( a cov]$ outpati5t drug t ! cov]$ entity or ph>macy pur*as$ "u ?is section to audit at ! ,secret>y's or ! manufactur]'s exp5se ! records ( ! cov]$ entity & contract ph>macy to assess compliance ) ! contract ph>macy requirem5ts "u p>agraph 7#aa7 ) respect to drugs ( ! manufactur]4 7,,ii7 ,process ,9 ord] to initiate an audit "u subclause 7,i71 a manufactur] %all-- 7aa7 demon/rate cr$ible allegations to ! ,secret>y ab\t noncompliance "u subp>agraph 7,b7 or 7,c7 ( p>agraph 7#aa7 & evid5ce ( good fai? outrea* to det]m9e compliance1 includ+ ?r\gh-- 7,,aa7 notification to ! cov]$ entity 9 writ+ :5 ! manufactur] det]m9$ t ! cov]$ entity may h violat$ ! requirem5ts "u subp>agraph 7,b7 or 7,c7 ( p>agraph 7#aa72 & 7,,bb7 provid+ ! cov]$ entity a #cj-;day p]iod1 beg9n+ on ! date ( notification "u subitem 7,,aa71 to resolve ! matt]2 & 7bb7 submit to ! ,secret>y evid5ce ( ! cr$ible allegations describ$ 9 item 7aa7 to reque/ au?orization to proce$ ) an audit ( ! cov]$ entity4 7,,iii7 ,corporate (fic]s ,a corporate (fic] ( ! cov]$ entity %all be responsible = corrections ( noncompliance id5tifi$ 9 an audit conduct$ "u ?is clause4 7,,iv7 ,au?ority to e/abli% audit process ,! ,secret>y %all e/abli%1 ?r\gh notice & comm5t rulemak+1 a process = mak+ a det]m9ation ( a cr$ible allegation "u ?is clause1 a timel9e = mak+ su* a det]m9ation1 & ! audit process relat+ to ! numb]1 scope1 & duration ( audits au?oriz$ "u ?is clause4 4 #d4 ,pati5t def9ition 7a7 ,pati5t def9ition 7#a7 ,9 g5]al ,section #cdj;,b7b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7b77 is am5d$ to add at ! end ( ! foll[+3 7#c7 ,pati5t 7,a7 ,9 g5]al ,9 ?is section1 ! t]m pati5t1 ) respect to a cov]$ entity1 means an individual :o-- 7i7 has receiv$ an outpati5t heal? c>e s]vice f ! cov]$ entity at any po9t )9 ! prec$+ #b ye>s2 7ii7 has a relation%ip ) ! cov]$ entity su* t ! cov]$ entity creates & ma9ta9s an auditable m$ical record 9 a =m & mann] consi/5t ) ,/ate & ,f$]al law1 t demon/rates ! exi/5ce ( a pati5t relation%ip 9 accordance ) ?is p>agraph = ea* prescription or ord] = a cov]$ outpati5t drug1 & ma9ta9s su* record = a p]iod ( at lea/ #c ye>s1 or long] if requir$ by ,/ate or ,f$]al law2 & 7iii7 receiv$ a prescription or ord] = a cov]$ outpati5t drug-- 7,i7 f a practition] z a result ( an outpati5t heal? c>e s]vice describ$ 9 clause 7i72 or 7,,ii7 z a result ( a ref]ral describ$ 9 subsection 7a77#ac74 7,b7 ,,aids drug pur*as+ assi/ance program pati5ts ,an individual regi/]$ 9 ! program ( a cov]$ entity describ$ 9 subsection 7a77#d77;,e7 is a pati5t ( ! cov]$ entity = purposes ( ?is p>agraph4 7,c7 ,/ate or political subdivision ( a ,/ate receiv+ fund+ "u section #cah ,an individual :o receives a drug pur*as$ by a ,/ate or political subdivision ( a ,/ate1 = ! treatm5t ( a disease or condition = :i* ! ,/ate or political subdivision ( a ,/ate has receiv$ su* aw>d "u section #cah1 is a pati5t exclusively ( ! ,/ate or political subdivision ( ! ,/ate = ! purpose ( qualify+ t prescription = #cdj;,b pric+ "u ?is section4 7,d7 ,exclusions ,= purposes ( ?is section1 an individual %all n be consid]$ a pati5t ( a cov]$ entity if ! outpati5t heal? c>e s]vices receiv$ by ! individual consi/ only (-- 7i7 ! adm9i/ration ( a drug1 or ! disp5s+ ( a drug = subsequ5t self-adm9i/ration or adm9i/ration 9 ! home sett+2 or 7ii7 an infusion ( a drug4 7,e7 ,exception = dis*>ge prescriptions ,9 ! case ( a pati5t dis*>g$ f an em]g5cy dep>tm5t or inpati5t hospital /ay f a cov]$ entity describ$ 9 any ( subp>agraph 7,a7 ?r\gh 7,o7 ( subsection 7a77#d7 t results 9 an outpati5t prescription1 a cov]$ entity may provide su* drug to ! individual z a cov]$ outpati5t drug pursuant to ! program "u ?is section1 & %all be deem$ to meet ! requirem5ts = e/abli%m5t ( a pati5t "u subp>agraph 7,a7 9 ! same mann] & "u ! same conditions z ! cov]$ entity w\ld provide su* drug to su* pati5t _h ! cov]$ entity prescrib$ ! drug4 7#d7 ,outpati5t heal? c>e s]vice ,! t]m outpati5t heal? c>e s]vice means an outpati5t heal? c>e s]vice-- 7,a7 t 0 furni%$ pursuant to a valid1 writt5 ord] t is docum5t$ or a ref]ral t is docum5t$ 9 ! m$ical record = ! pati5t t is ma9ta9$ by ! cov]$ entity2 & 7,b7 7i7 = :i* reimbursem5t "u title ,,xviii or ,,xix ( ! ,social ,security ,act w\ld be available :5 ! s]vices 7 furni%$2 7ii7 t c be id5tifi$ by a ,,cpt e/abli%$ by ! ,am]ican ,m$ical ,association or ,,hcpcs code e/abli%$ by ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices z ( ! date ! s]vices 7 furni%$2 or 7iii7 9 ! case ( cov]$ entity describ$ 9 any ( subp>agraphs 7,a7 ?r\gh 7,k7 ( subsection 7a77#d71 t is a s]vice t is consi/5t ) ! scope ( ! grant or designation describ$ 9 ! applicable su* subp>agraph4 7#e7 ,practition] ,! t]m practition] means a heal? c>e practition] :o-- 7,a7 7i7 is an employee or indep5d5t contractor ( a cov]$ entity1 & ! cov]$ entity bills = su* s]vices & is responsible = ! c>e furni%$ by su* practition]2 or 7ii7 furni%es heal? c>e s]vices "u an ongo+ contractual obligation to a cov]$ entity1 coop]ative arrangem5t pursuant to section #ccj ) a cov]$ entity describ$ 9 subsection 7a77#d77;,a71 or1 only 9 ! case ( a cov]$ entity t is prohibit$ to ent] into contractual obligations1 pursuant to m$ical /aff memb]%ip ) a cov]$ entity1 su* t ! cov]$ entity ma9ta9s cl9ical responsibility = ! heal? c>e s]vices t result$ 9 ! pati5t receiv+ a prescription or ord] = ! cov]$ outpati5t drug2 & 7,b7 is n exclud$1 pursuant to section #aabh ( ! ,social ,security ,act1 f p>ticipation 9 ! ,m$ic>e program or a ,/ate heal? c>e program 7z def9$ 9 section #aabh7;h7 ( ! ,social ,security ,act74 4 7#b7 ,audits ,section #cdj;,b7a77#e77;,c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77#e77;,c771 z am5d$ by section #c7;e71 is fur!r am5d$ by add+ at ! end ! foll[+3 7iii7 ,audits relat+ to pati5t /atus 7,i7 ,9 g5]al ,a cov]$ entity provid+ cov]$ outpati5t drugs pursuant to an agreem5t "u p>agraph 7#a7 %all p]mit ! ,secret>y & ! manufactur] to audit1 at ! ,secret>y's or manufactur]'s exp5se1 ! records ( ! entity ) respect to drugs ( ! manufactur] t directly p]ta9 to ! entity's compliance )-- 7aa7 treat+ individuals z pati5ts ( ! entity only z describ$ 9 subsection 7b77#c72 & 7bb7 ! requirem5ts = provid+ su* drugs to ref]r$ pati5ts pursuant to p>agraph 7#ac74 7,,ii7 ,audit+ ,! ,secret>y %all audit ! records ( cov]$ entities ) respect to records describ$ 9 ?is clause n less frequ5tly ?an e #c ye>s1 & %all audit high-risk & high-volume1 z def9$ by ! ,secret>y1 cov]$ entities m frequ5tly1 9 a mann] t is n ov]ly burd5some to ! cov]$ entity4 ,! ,secret>y %all e/abli% a me*anism = manufactur]s to reque/ & au?orize audits specific to ref]ral prescription eligibility "u p>agraph 7#ac7 ^u demon/ration ( a cr$ible allegation ( non-compliance4 7,,iii7 ,au?ority to e/abli% process ,! ,secret>y %all e/abli%1 ?r\gh notice & comm5t rulemak+1 a process = manufactur]s & cov]$ entities to make a good fai? attempt to resolve any conc]ns id5tifi$ by a manufactur] prior to ! initiation ( an audit "u ?is clause4 ,a manufactur] %all provide to ! cov]$ entity ! same mat]ials t ! manufactur] provid$ to ! ,secret>y to support a cr$ible allegation "u ?is clause1 z det]m9$ by ! ,secret>y4 4 7#c7 ,en=cem5t ,section #cdj;,b7a77#e77;,d7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77#e77;,d77 is am5d$-- 7,a7 by /rik+ subp>agraphs 7,a7 & ins]t+ subp>agraph 7,a72 7,b7 by /rik+ ,if ! ,secret>y & ins]t+ ! foll[+3 7i7 ,9 g5]al ,if ! ,secret>y 2 & 7,c7 by add+ at ! end ! foll[+3 7ii7 ,sanctions = noncompliance ) pati5t /atus requirem5ts ,if ! ,secret>y det]m9es1 aft] an audit describ$ 9 subp>agraph 7,c77iii71 a cov]$ entity to n be 9 compliance ) ! requirem5ts ( treat+ an individual z a pati5t ( ! cov]$ entity z describ$ 9 subsection 7b77#c7 or ! requirem5ts ( p>agraph 7#ac7-- 7,i7 ! cov]$ entity %all develop a corrective action plan1 :i* %all be subject to approval & monitor+ by ! ,secret>y2 & 7,,ii7 if ! ,secret>y det]m9es t ! cov]$ entity has n adequately correct$ its noncompliance 9 accordance ) su* plan-- 7aa7 ! cov]$ entity %all be ineligible to p>ticipate 9 ! drug disc\nt program "u ?is section = a p]iod det]m9$ by ! ,secret>y1 n to exce$ #c ye>s2 & 7bb7 ! ,secret>y may ord] ! cov]$ entity to pay civil monet>y p5alties1 pursuant to subp>t ,o ( "p #ajjc ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulations71 ) respect to any cov]$ outpati5t drugs pur*as$ by ! cov]$ entity dur+ ! p]iod 9 :i* ! cov]$ entity 0 f\nd to be n 9 compliance ) ! requirem5ts ( treat+ an individual z a pati5t ( ! entity z describ$ 9 subsection 7b77#c7 or ! requirem5ts ( p>agraph 7#ac74 4 7b7 ,cov]$ entity regi/ration ,section #cdj;,b7a77#e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77#e77 is am5d$ by add+ at ! end ! foll[+3 7,e7 ,cov]$ entity regi/ration ,z a condition = p>ticipation 9 ! drug disc\nt program "u ?is section1 a cov]$ entity %all regi/] ) ! ,secret>y & be li/$ on ! #cdj;,b ,(fice ( ,ph>macy ,affairs ,in=mation ,sy/em 7or a successor to su* sy/em74 4 7c7 ,treatm5t ( c]ta9 prescriptions = pati5ts ref]r$ to non-#cdj;,b provid]s ,section #cdj;,b7a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a771 z am5d$ by section #c7;b71 is fur!r am5d$ by add+ at ! end ! foll[+3 7#ac7 ,ref]ral prescriptions 7,a7 ,9 g5]al ,9 ! case ( a pati5t ( an eligible cov]$ entity :o is ref]r$ by su* cov]$ entity to a prescrib+ provid] :o is n provid+ c>e on behalf ( a cov]$ entity1 & su* prescrib+ provid] prescribes a drug )9 #ab mon?s ( ! pati5t receiv+ su* ref]ral1 ! eligible cov]$ entity may provide su* drug to su* pati5t z a cov]$ outpati5t drug pursuant to ! program "u ?is section1 9 ! same mann] & "u ! same conditions z ! cov]$ entity w\ld provide su* drug to su* pati5t _h ! cov]$ entity prescrib$ ! drug1 9 accordance ) ! requirem5ts "u subp>agraph 7,c74 7,b7 ,eligible cov]$ entity ,= purposes ( ?is p>agraph1 a cov]$ entity is an eligible cov]$ entity if su* entity is-- 7i7 an entity describ$ 9 any ( subp>agraphs 7,a7 ?r\gh 7,k7 or 7,n7 ( p>agraph 7#d72 or 7ii7 a sole community hospital describ$ 9 p>agraph 7#d77,o74 7,c7 ,requirem5ts 7i7 ,9 g5]al ,an eligible cov]$ entity may provide a drug to a pati5t z describ$ 9 subp>agraph 7,a7 only if-- 7,i7 ! cov]$ entity has a docum5t$ relation%ip ) ! pati5t1 z describ$ 9 subsection 7b77#c71 & has docum5tation ( ! provision ( c>e provid$ by ! cov]$ entity & ! prescrib+ provid] & consultation ) ! prescrib+ provid] reg>d+ su* pati5t1 includ+ docum5tation ( ! ref]ral & ! prescription2 7,,ii7 ! pati5t 0 ref]r$ to ! prescrib+ provid] :o prescrib$ ! drug by ! cov]$ entity2 7,,iii7 ! prescription is fill$ at ! cov]$ entity's :olly-own$ ph>macy or contract ph>macy2 7,,iv7 ! cov]$ entity ma9ta9s1 = a p]iod ( at lea/ #c ye>s1 docum5tation ( compliance ) ?is p>agraph1 includ+ all docum5ts subject to audit "u p>agraph 7#e77;,c72 7,v7 ! cov]$ entity does n %>e ! sav+s receiv$ f pur*as+ ! cov]$ outpati5t drug ) ! prescrib+ provid]2 & 7,,vi7 ! cov]$ entity meets su* o!r requirem5ts z ! ,secret>y may e/abli% ?r\gh notice & comm5t rulemak+4 7ii7 ,except$ drugs 7,i7 ,9 g5]al ,except z provid$ 9 subclause 7,,ii71 a cov]$ entity may n provide a pati5t a cov]$ outpati5t drug pursuant to subp>agraph 7,a7 if su* drug-- 7aa7 is an infus$ drug2 7bb7 is a cl9ician-adm9i/]$ drug2 or 7cc7 o!rwise requires adm9i/ration by a cl9ician4 7,,ii7 ,exceptions ,a cov]$ entity may provide a pati5t a cov]$ outpati5t drug describ$ 9 subclause 7,i7 pursuant to subp>agraph 7,a7 if-- 7aa7 ! eligible cov]$ entity is a cov]$ entity describ$ 9 p>agraph 7#d77;,a7 & 0 provid+ infusion s]vices necess>y to deliv] a requir$ prim>y heal? s]vice or an additional heal? s]vice 7z def9$ 9 section #ccj7;b77#a77 pursuant to fund+ receiv$ "u section #ccj1 z ( ! date ( enactm5t ( ! ,,su/a9 #cdj;,b ,act2 or 7bb7 ! ,secret>y det]m9es1 ?r\gh notice & comm5t rulemak+1 t l[-income1 m$ically und]s]v$ resid5ts ( ! s]vice area ( ! eligible cov]$ entity lack access to infusion s]vices )9 a reasonable di/ance & bas$ on ?is det]m9ation1 ! eligible cov]$ entity receives approval f ! ,secret>y to provide ^! s]vices pursuant to fund+ provid$ "u section #ccj1 subject to all ! requirem5ts ( t section4 7,d7 ,rule ( con/ruction ,no?+ 9 ?is p>agraph %all be con/ru$ to affect ! application ( subsection 7e74 7,e7 ,address+ significant volume ( drugs provid$ to ref]r$ pati5ts 7i7 ,9 g5]al ,! ,secret>y %all audit any eligible cov]$ entity t1 9 any ye>1 provides cov]$ outpati5t drugs to pati5ts :o receiv$ a prescription = su* drug f a provid] :o is n a cov]$ entity 9 a volume t exce$s ! less] (-- 7,i7 #bj p]c5t ( ! total numb] ( cov]$ outpati5t drugs pur*as$ by ! cov]$ entity at or bel[ ! applicable ceil+ price & disp5s$ by ! cov]$ entity = ! ye>2 or 7,,ii7 ! av]age annual p]c5tage ov] ! mo/ rec5t #c-ye> p]iod1 ( ! total numb] ( cov]$ outpati5t drugs pur*as$ by ! cov]$ entity at or bel[ ! applicable ceil+ price = ! ye> & disp5s$ by ! cov]$ entity to pati5ts1 t 7 disp5s$ to pati5ts :o receiv$ a prescription = su* drug f a provid] :o is n a cov]$ entity4 7ii7 ,h>d%ip exceptions ,! ,secret>y %all develop specific crit]ia = a h>d%ip exceptions process1 t is n ov]ly burd5some to a cov]$ entity1 "u :i* an eligible cov]$ entity may exce$ ! ?re%old e/abli%$ "u clause 7i7 )\t requir+ an audit describ$ 9 su* clause only if ! eligible cov]$ entity provides requir$ in=mation to ! ,secret>y to demon/rate su* h>d%ip1 su* z a m$ical ne$ or work=ce %ortage1 9 accordance ) ! crit]ia e/abli%$ by ! ,secret>y4 7iii7 ,report+ ,a cov]$ entity %all report annually to ! ,secret>y-- 7,i7 ! p]c5tage ( ! cov]$ entity's rev5ue "u ! drug disc\nt program d]iv$ f drugs prescrib$ by a prescrib+ provid] pursuant to ?is subsection2 & 7,,ii7 ! p]c5tage ( ! total numb] ( cov]$ outpati5t drugs pur*as$ by ! cov]$ entity t 7 prescrib$ by a prescrib+ provid] pursuant to ?is subsection4 7iv7 ,public availability ( in=mation ,! ,secret>y %all make aggregate in=mation on eligible cov]$ entities id5tifi$ "u clause 7i7 available on ! website ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration1 9 su* =m & mann] t ! ,secret>y det]m9es appropriate1 & %all n id5tify any specific cov]$ entity4 7,f7 ,en=cem5t 7i7 ,corrective action plan ,9 ! case t ! ,secret>y f9ds t a cov]$ entity has fail$ to comply ) any requirem5t "u ?is p>agraph1 su* cov]$ entity %all be requir$ to submit a corrective action plan to ! ,secret>y1 :i* %all be subject to approval & monitor+ by ! ,secret>y4 7ii7 ,loss ( ref]ral au?orization ,a cov]$ entity t fails to comply ) a corrective action plan )9 #ahj days ( approval ( su* plan by ! ,secret>y "u clause 7i7 %all become ineligible to provide cov]$ outpati5t drugs to ref]r$ pati5ts "u subp>agraph 7,a7 = su* p]iod ( "t det]m9$ by ! ,secret>y "u ! corrective action plan1 n to exce$ #c ye>s4 7iii7 ,monet>y p5alties ,! ,secret>y may impose civil monet>y p5alties1 pursuant to subp>t ,o ( "p #ajjc ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulations71 on a cov]$ entity = any disc\nts receiv$ by su* entity on cov]$ outpati5t drugs provid$ to ref]r$ pati5ts "u ?is p>agraph1 if ! cov]$ entity is f\nd to be noncompliant ) ! requirem5ts ( ?is p>agraph ) respect to ! relevant drug4 7,g7 ,def9itions ,= ! purposes ( ?is p>agraph-- 7i7 ! t]m prescrib+ provid] means a lic5s$ heal? c>e provid] :o prescribes a drug to a pati5t ( a cov]$ entity bas$ on ! ref]ral ( ! pati5t by ! cov]$ entity to ! provid]2 & 7ii7 ! t]m ref]ral means a writt51 electronic1 or o!rwise docum5t$ ord] by a lic5s$ heal? c>e provid] ord]+1 or ! rec]tify+ ( ! ne$ =1 a heal? s]vice4 4 7d7 ,,oig report on ref]ral prescriptions ,! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all-- 7#a7 dur+ ! #ab-ye> p]iod beg9n+ on ! date ( enactm5t ( ?is ,act1 conduct an annual /udy on cov]$ outpati5t drugs provid$ pursuant to prescriptions = ref]r$ pati5ts "u p>agraph 7#ac7 ( section #cdj;,b7a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a771 z add$ by subsection 7c72 & 7#b7 n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 & = ea* ( ! next #aj ye>s1 submit to ,congress a report on ! /udy "u p>agraph 7#a74 #e4 #cdj;,b ,rebate ,model ,pilot ,program sunset ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices 7ref]r$ to 9 ?is section z ! ,secret>y7 %all conclude ! #cdj;,b ,rebate ,model ,pilot ,program1 or a sub/antially simil> program e/abli%$ by ! ,dep>tm5t ( ,heal? & ,human ,s]vices4 ,! #cdj;,b ,rebate ,model ,pilot ,program1 or a sub/antially simil> program1 %all n be exp&$4 ,"o ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all discont9ue ! #cdj;,b ,rebate ,model ,pilot ,program1 or a sub/antially simil> program1 & transition to ! #cdj;,b ,drug ,disc\nt ,program ,data ,cle>+h\se e/abli%$ "u section #aaej;,d ( ! ,social ,security ,act1 z add$ by section #i7;a74 #f4 ,*ild sites 7a7 ,9 g5]al ,section #cdj;,b7a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a771 z am5d$ by section #d7;c71 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 rec]tify to ! ,secret>y ?r\gh su* c]tification processes e/abli%$ "u title ,,xviii ( ! ,social ,security ,act1 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>y1 :i*1 9 ! case ( a *ild site t is eligible = p>ticipation z describ$ 9 subp>agraph 7,b77ii71 %all include submission ( ! atte/ation 7abs5t bill+ requirem5ts7 t ! *ild site meets ! ,m$ic>e provid]-bas$ rules "u section #dac4fe ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulations72 7ii7 apply+ ! same f9ancial assi/ance policy = pati5ts z applies ) respect to o!r sites op]at$ by ! cov]$ entity2 & 7iii7 ensur+ t ea* *ild site complies ) ! ,m$ic>e provid]-bas$ rules "u section #dac4fe ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulations71 or meets ! requirem5ts ( subp>agraph 7,b77i74 7,b7 ,eligibility = *ild sites 7i7 ,9 g5]al ,a *ild site is eligible = p>ticipation 9 ! drug disc\nt program "u ?is section1 ?r\gh ! eligibility ( ! cov]$ 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 f9ancial assi/ance policy = pati5ts z ! cov]$ entity4 7,,ii7 ,! *ild site ensures t ! provid]s :o ord] or disp5se cov]$ outpati5t drugs pur*as$ "u ?is section at ! *ild site or a contract ph>macy ( ! cov]$ entity h cl9ical responsibility = heal? c>e s]vices t result 9 ! receipt ( a prescription or ord] ( ! cov]$ outpati5t drug pur*as$ "u ?is section t is disp5s$4 7,,iii7 ,! *ild site provides a cl9ically mean+ful range ( s]vices1 z det]m9$ by ! s]vices t provid]s or suppli]s employ$ by1 contract$ )1 or au?oriz$ to provide s]vices at1 ! *ild site are qualifi$ to deliv]4 7,,iv7 ,! *ild site is op]at$ "u ! same lic5se z ! cov]$ entity1 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,v7 ,! 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,,vi7 ,! 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,,vii7 ,! *ild site is held out to ! public z "p ( ! cov]$ entity1 su* t1 :5 pati5ts ent] ! *ild site1 !y are aw>e t !y are ent]+ ! cov]$ entity4 7,,viii7 ,! *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]$ entity4 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$ical /aff appo9tm5ts at ! *ild site4 7,,ix7 ,! report+ relation%ip betwe5 ! *ild site & ! cov]$ 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 ) ! 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,x7 ,! 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,,xi7 7aa7 ,! *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 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 7bb7 ,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 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 to det]m9e :e!r a *ild site1 z det]m9$ by ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices1 complies ) ! ,m$ic>e provid]-bas$ rules "u section #dac4fe ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7iii7 ,process = regi/ration ,! ,secret>y %all develop a process = ! regi/ration ( *ild sites t are eligible = p>ticipation "u clause 7i7 or 7ii74 7iv7 ,eligibility delay = c]ta9 *ild sites 7,i7 ,newly acquir$ sites 7aa7 ,9 g5]al ,except z provid$ 9 item 7bb71 a *ild site acquir$ by a cov]$ entity aft] ! date ( enactm5t ( ! ,,su/a9 #cdj;,b ,act t 0 n eligible to p>ticipate 9 ! drug disc\nt program prior to su* date %all n be eligible to p>ticipate 9 ! drug disc\nt program "u ?is section until ! date t is #c ye>s aft] ! date ( su* acquisition4 7bb7 ,h>d%ip exemption ,! ,secret>y may1 on a case-by-case basis1 det]m9e t a newly acquir$ *ild site w be eligible to p>ticipate 9 ! drug disc\nt program "u ?is section on a specifi$ date )9 #ahj days aft] ! date ( acquisition by ! cov]$ entity4 7,,ii7 ,newly con/ruct$ sites ,a newly con/ruct$ *ild site t began op]ations aft] ! date ( enactm5t ( ! ,,su/a9 #cdj;,b ,act %all n be eligible to p>ticipate 9 ! drug disc\nt program z describ$ 9 clause 7i7 unless su* site meets all ( ! requirem5ts "u ?is subp>agraph4 7,c7 ,inappropriate treatm5t ( a provid] z a *ild site ,n lat] ?an #ahj days aft] ! fir/ rec]tification ( ! cov]$ entity t occurs aft] ! date ( enactm5t ( ! ,,su/a9 #cdj;,b ,act1 ! ,secret>y %all e/abli% a process ?r\gh notice & comm5t rulemak+ = det]m9+ ! /atus ( a *ild site t1 prior to su* date ( enactm5t1 0 deem$ qualifi$ z a *ild site b t does n meet ! crit]ia set =? 9 ?is subsection4 7,d7 ,reports 7i7 ,,gao report on program integrity ,n lat] ?an #c ye>s aft] ! date ( enactm5t ( ! ,,su/a9 #cdj;,b ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! appropriate committees ( ,congress a report t analyzes relevant data1 includ+ data made available pursuant to subsection 7d77#e71 & makes recomm5dations ) respect to any policies ne$$ to address program integrity issues associat$ ) *ild sites 9 ! drug disc\nt program "u ?is section4 7ii7 ,,hhs reports to ,congress ,n lat] ?an #b ye>s aft] ! date ( enactm5t ( ! ,,su/a9 #cdj;,b ,act1 & e #b ye>s !reaft]1 ! ,secret>y %all submit to ! appropriate committees ( ,congress a report t analyzes ! use ( *ild sites 9 ! drug disc\nt program "u ?is section1 & t-- 7,i7 *>act]izes ! scope & nature ( *ild sites 9 ! drug disc\nt program "u ?is section1 includ+-- 7aa7 ! numb] ( newly acquir$ *ild sites2 7bb7 ! numb] ( newly con/ruct$ *ild sites2 7cc7 ! conc5tration ( ! *ild sites across geographic areas2 & 7dd7 ! pay]-mix ( ! *ild sites2 7,,ii7 assesses ! effect ( eligibility delays describ$ 9 subp>agraph 7,b77iv72 & 7,,iii7 makes recomm5dations ) respect to policies ne$$ to address any issues id5tifi$ 9 su* report4 7iii7 ,,gao report on be/ practices ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,,su/a9 #cdj;,b ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit a report to ! appropriate committees ( ,congress t-- 7,i7 analyzes input solicit$ f relevant /akehold]s1 includ+ cov]$ entities & manufactur]s1 reg>d+ pot5tial be/ practices = ensur+ sav+s receiv$ by *ild sites ?r\gh p>ticipation 9 ! drug disc\nt program "u ?is section are us$ to mean+fully improve access to c>e1 includ+ by exp&+ access to heal? c>e s]vices or heal?-relat$ b5efits = pati5ts & communities s]v$ by ! cov]$ entity1 includ+ *ild sites ( ! cov]$ entity2 & 7,,ii7 makes recomm5dations to ! ,secret>y & appropriate committees ( ,congress ) respect to implem5tation ( be/ practices id5tifi$ & analyz$ pursuant to subclause 7,i74 4 7b7 ,recordkeep+ ,section #cdj;,b7a77#e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77#e771 z am5d$ by section #d7;b71 is fur!r am5d$ by add+ at ! end ! foll[+3 7,f7 ,*ild site recordkeep+ ,9 ! case ( a cov]$ entity t has regi/]$ a *ild site pursuant to p>agraph 7#ad71 ! cov]$ entity %all ma9ta9 auditable records = a p]iod ( at lea/ #c ye>s & be subject to audits by ! ,secret>y ( records t p]ta9 to ! compliance ( ! cov]$ entity & *ild site ) ! provisions ( p>agraph 7#ad74 4 #g4 ,transp>5cy 7a7 ,9 g5]al ,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 ( ! ,,su/a9 #cdj;,b ,act1 & annually !reaft]1 ea* cov]$ entity %all report to ! ,secret>y ! foll[+ in=mation ) respect to ! cov]$ entity1 includ+ ) respect to all *ild sites & contract ph>macy arrangem5ts1 = ! prec$+ ye>3 7i7 ,! total numb] ( individuals :o 7 disp5s$ or adm9i/]$ cov]$ outpati5t drugs dur+ su* prec$+ ye> t 7 subject to an agreem5t "u subsection 7a77#a74 7ii7 ,! total numb] ( prescriptions disp5s$ or adm9i/]$ ) cov]$ outpati5t drugs pur*as$ "u ?is section & bill$ to insurance1 organiz$ by type ( heal? insurance cov]age 7z specifi$ by ! ,secret>y1 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* cov]$ entity = *>ity c>e1 report$ z a fraction1 :]e ! num]ator is ! am\nt ( *>ity c>e report$ on work%eet ,s-#aj ( ! ,m$ic>e co/ report 7or any successor71 & ! d5om9ator is ! total op]at+ co/ ( ! cov]$ entity1 z report$ = ! mo/ rec5t co/ report+ p]iod2 or 7,,ii7 9 ! case ( a cov]$ entity t is n requir$ to submit a ,m$ic>e co/ report1 a qualitative description ( ! *>ity c>e provid$ by ! cov]$ entity1 to ! ext5t applicable "u ! scope ( ! grant = a cov]$ entity describ$ 9 any ( subp>agraphs 7,a7 ?r\gh 7,o7 ( subsection 7a77#d71 9 su* mann] t is n ov]ly burd5some to cov]$ entities1 z ! ,secret>y may require4 7iv7 ,at ! option ( ! cov]$ entity1 in=mation p]ta9+ to "u-reimburs$ c>e provid$ by ! cov]$ entity4 7v7 7,i7 ,a description1 submitt$ 9 a /&>diz$ =m & mann] prescrib$ by ! ,secret>y1 ( ! 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$1 un9sur$1 or m$ically vuln]able pati5ts & communities2 & 7,,ii7 an atte/ation by ! *ief executive (fic]1 *ief executive f9ancial (fic]1 or *ief op]at+ (fic] c]tify+ t su* sav+s h be5 us$ to b5efit ! pati5ts & communities s]v$ by ! cov]$ entity4 7vi7 ,! 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;,b72 7,,iii7 ! p]c5tage ( pati5ts :o reside 9 or are "p ( a m$ically und]s]v$ population 7z def9$ 9 section #ccj7;b77#c772 7,,iv7 ! p]c5tage ( un9sur$ pati5ts2 7,v7 ! p]c5tage ( pati5ts :o are ,m$icaid b5efici>ies2 & 7,,vi7 ! p]c5tage ( pati5ts :o are ,*ildr5's ,heal? ,insurance ,program b5efici>ies4 7vii7 ,policies ( ! cov]$ entity to promote access & adh]5ce to prescrib$ m$ication4 7viii7 ,9 ! case ( a nongov]nm5tal hospital1 any contracts betwe5 su* hospital & a ,/ate or local gov]nm5tal entity1 & any modifications to any su* contract4 7ix7 ,any ?ird-p>ty adm9i/rators 9 contract ) ! cov]$ entity = ! adm9i/ration ( ! drug disc\nt program4 7x7 ,! 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 7xi7 ,! numb] ( pati5ts us+ ! outpati5t s]vices ( ! cov]$ entity4 7xii7 ,op]ation co/s to ! cov]$ entity relat$ to ! drug disc\nt program "u ?is section4 7,b7 ,records ret5tion ,a cov]$ entity %all reta9 records describ$ 9 subp>agraph 7,a7 = a p]iod ( at lea/ #c ye>s & provide su* records & reports z ! ,secret>y det]m9es necess>y = purposes ( c>ry+ out ?is p>agraph4 7,c7 ,availability ( in=mation 7i7 ,9 g5]al ,n lat] ?an #ij days aft] receiv+ ! in=mation report$ by cov]$ entities "u p>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 ea* type ( cov]$ entity describ$ 9 subsection 7a77#d74 ,9 c>ry+ out ?is p>agraph1 ) respect to data report$ pursuant to p>agraph 7#a71 ! ,secret>y %all ensure t any propriet>y in=mation be r$act$ f contracts submitt$ pursuant to subp>agraph 7,a77viii7 be=e po/+ su* contracts4 7,d7 ,submission process ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,,su/a9 #cdj;,b ,act1 ! ,secret>y %all e/abli% a process by :i* ! in=mation requir$ to be submitt$ "u subp>agraph 7,a7 may be submitt$ directly to ! #cdj;,b ,(fice ( ,ph>macy ,affairs ,in=mation ,sy/em 7or a successor to su* sy/em74 7,e7 ,reports to ,congress ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ! ,,su/a9 #cdj;,b ,act1 & annually !reaft]1 ! ,secret>y %all submit a report to ! appropriate committees ( ,congress on ! in=mation collect$ "u subp>agraph 7,a74 7,f7 ,regulations ,! ,secret>y may promulgate regulations to c>ry out ?is p>agraph4 4 7b7 ,audit+ ,section #cdj;,b7a77#e77;,c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77#e77;,c771 z am5d$ by section #d7;a77#b71 is fur!r am5d$ by add+ at ! end ! foll[+3 7iv7 ,audits ( program sav+s records ,a cov]$ entity %all p]mit ! ,secret>y to audit1 at ! ,secret>y's exp5se1 ! records ( ! cov]$ entity us$ = purposes ( report+ "u subsection 7d77#e77;,a71 includ+ h[ ! disc\nt f drugs subject to an agreem5t "u p>agraph 7#a7 is us$ by ! cov]$ entity4 4 #h4 ,enhanc+ program integrity 7a7 ,audits 7#a7 ,9 g5]al ,section #cdj;,b7a77#e77;,c7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77#e77;,c771 z am5d$ by section #g7;b71 is fur!r am5d$ by add+ at ! end ! foll[+3 7v7 ,additional audits 7,i7 ,9 g5]al ,9 addition to ! audits o!rwise au?oriz$ "u ?is subp>agraph1 ! ,secret>y may audit1 to assess compliance ) requirem5ts "u ?is section-- 7aa7 cov]$ entities1 includ+ ! *ild sites ( a cov]$ entity & contract ph>macies1 to id5tify any violations "u ?is section1 includ+ violations relat$ to improp]ly claim+ eligibility = ! program "u ?is section1 drug div]sion1 duplicate disc\nts1 use ( contract ph>macies1 or claim+ a disc\nt "u ?is section on a drug t is n a cov]$ outpati5t drug pur*as$ pursuant to an agreem5t "u p>agraph 7#a72 & 7bb7 manufactur]s1 includ+ to id5tify any failure to provide an accurate ceil+ price4 7,,ii7 ,/&>ds ,! ,secret>y %all conduct audits describ$ 9 ?is clause 9 accordance ) g5]ally accept$ /&>ds t ! ,secret>y det]m9es appropriate & %all make ! protocol = su* audits publicly available4 7,,iii7 ,requirem5ts ,! ,secret>y may n close an audit describ$ 9 subclause 7,i7 be=e a corrective action plan requir$ by ! ,secret>y has be5 fully implem5t$1 z applicable4 7,,iv7 #cdj;,b v5dor in=mation ,to meet ! requirem5ts = submission ( in=mation = audits "u ?is clause1 ) respect to c>ry+ out ! program "u ?is section1 a cov]$ entity %all contract only ) v5dors agree+ to-- 7aa7 submit data to ! ,secret>y & indep5d5t outside auditors contract+ ) ! cov]$ entity z 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 p>agraph 7#a72 & 7bb7 respond to reque/s f auditors 9 a timely mann]1 z det]m9$ by ! ,secret>y4 7,v7 ,consequ5ces ( audit ,! ,secret>y %all ensure t1 9 ! case ( an audit f9d+ t-- 7aa7 a cov]$ entity did n meet "o or m ( ! eligibility crit]ia = be+ a cov]$ entity1 z def9$ 9 p>agraph 7#d71 dur+ ! full p]iod "u review 9 an audit1 ! audit results 9 consequ5ces t are consi/5t & appropriate ) ! violation & t d n treat ! failure to meet eligibility crit]ia z an issue t c be correct$ retroactively2 or 7bb7 a manufactur] did n meet its requirem5ts pursuant to an agreem5t "u p>agraph 7#a7 dur+ ! full p]iod "u review 9 an audit1 ! audit results 9 consequ5ces t are consi/5t & appropriate ) ! violation & t d n treat ! failure to meet ! crit]ia z an issue t c be correct$ retroactively4 7,,vi7 ,regulations ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,,su/a9 #cdj;,b ,act1 ! ,secret>y %all e/abli%1 ?r\gh notice & comm5t rulemak+1 ! audit & report+ proc$ures requir$ by ?is clause4 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 kn[+ly & int5tionally fails to implem5t a corrective action plan relat+ to a violation involv+ improp]ly claim+ eligibility = ! program "u ?is section1 drug div]sion1 duplicate disc\nts1 compliance ) contract ph>macy requirem5ts1 or claim+ a disc\nt on a drug t is n a cov]$ outpati5t drug 7or claim+ a rebate on a drug 9 ! case ( an ,,aids drug pur*as+ assi/ance program1 z det]m9$ by ! ,secret>y71 )9 #ahj days ( ! ,secret>y notify+ ! entity ( ! requirem5t = su* plan1 unless ! ,secret>y det]m9es x is appropriate to all[ additional "t = compliance1 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 t relate to eligibility1 drug div]sion1 duplicate disc\nts1 compliance ) contract ph>macy requirem5ts1 or claim+ a disc\nt on a drug t is n a cov]$ outpati5t drug 7or claim+ a rebate on a drug 9 ! case ( an ,,aids drug pur*as+ assi/ance program describ$ 9 subsection 7a77#d77;,e71 z det]m9$ by ! ,secret>y71 & assign+ responsibility = mak+ corrections relat+ to su* a violation to a corporate (fic] ( ! cov]$ entity4 7vii7 7,i7 ,e/abli%+ a process = a cov]$ entity to develop & implem5t a corrective action plan1 & a process by :i* ! ,secret>y provides = prop] & timely notification ( a pot5tial violation by a cov]$ entity4 7,,ii7 ,dis5roll+ f ! program a cov]$ entity t fails to implem5t a corrective action plan )9 #ahj days ( issuance ( a f9al audit report relat$ to a /atutory violation involv+ improp]ly claim+ eligibility = ! program "u ?is section1 drug div]sion1 duplicate disc\nts1 compliance ) contract ph>macy requirem5ts1 claim+ a disc\nt on a drug t is n a cov]$ outpati5t drug 7or claim+ a rebate on a drug 9 ! case ( an ,,aids drug pur*as+ assi/ance program describ$ 9 subsection 7a77#d77;,e71 z det]m9$ by ! ,secret>y71 or fail+ to comply ) report+ ( program sav+s & use ( program sav+s z requir$4 4 7b7 ,v]ification ( private non-,pr(it hospital contracts ) ,/ate or local gov]nm5ts ,section #cdj;,b7a77#e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77#e771 z am5d$ by section #f7;b71 is fur!r am5d$ by add+ at ! end ! foll[+3 7,g7 ,v]ification ( private non-pr(it hospital contracts ) ,/ate or local gov]nm5ts 7i7 ,9 g5]al ,9 ! case ( 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 :e!r ! hospital is 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 ( p>agraph 7#d71 ! ,secret>y %all take all ( ! foll[+ /eps1 ea* ( :i* %all be docum5t$3 7,i7 ,prior to regi/]+ or approv+ annual rec]tification ( su* a hospital 7or :ile c>ry+ out any program audit ( su* a hospital71 ! ,secret>y %all obta9 & review ! hospital's contract ) a ,/ate or local gov]nm5t & %all v]ify & docum5t t-- 7aa7 ! docum5t provid$ 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 7bb7 ! 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 7cc7 ! contract specifies an effective date2 7dd7 ! 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 & 7ee7 ! 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 7,,ii7 ,! ,secret>y %all v]ify ! contracts meet+ ! requirem5ts ( clause 7i7 = all cov]$ entities describ$ 9 ?is subp>agraph & regi/]$ z ( ! date ( enactm5t ( ! ,,su/a9 #cdj;,b ,act by no lat] ?an #a ye> aft] ! date ( enactm5t ( ! ,,su/a9 #cdj;,b ,act4 7,,iii7 ,! ,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 items 7aa7 ?r\gh 7ee7 ( subclause 7,i74 7ii7 ,process ,! ,secret>y %all develop a process to v]ify ! contracts meet+ ! requirem5t ( clause 7i77,i71 includ+ specify+ a timel9e4 4 7c7 ,v]ification ( c]ta9 cov]$ entities ,section #cdj;,b7a77#d77,l77i7 ( ! ,public ,heal? ,s]vices ,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 #i4 ,prev5t+ duplicate disc\nts 7a7 #cdj;,b drug disc\nt program data cle>+h\se ,"p ,a ( title ,,xi ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acja et seq47 is am5d$ by add+ ! foll[+ ! foll[+ new section3 #aaej;,d4 #cdj;,b drug disc\nt program data cle>+h\se 7a7 ,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 entity 7:o %all be free ( conflicts ( int]e/ ) cov]$ entities1 manufactur]s1 heal? plans1 ?ird-p>ty adm9i/rators ( heal? plans1 entities provid+ ph>macy b5efit managem5t s]vices to heal? plans1 & ( o!r conflicts ( int]e/ z specifi$ by ! ,secret>y7 = purposes ( c>ry+ out ! cle>+h\se duties "u subsection 7b7 ) respect to ! #cdj;,b drug disc\nt program to prev5t duplicate disc\nts & ensure prop] acc\nt+4 ,su* contract %all provide t ! ?ird-p>ty entity %all p]=m ! duties describ$ 9 subsection 7b7 & %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 7b7 ,duties ,) respect to #cdj;,b drugs t are disp5s$ to individuals :o are entitl$ to or eligible = b5efits "u ! ,m$ic>e program "u title ,,xviii1 ! ,m$icaid program "u title ,,xix 7includ+ b5efits provid$ "u ! ,m$icaid program ?r\gh a manag$ c>e arrangem5t71 ! ,*ildr5's ,heal? ,insurance ,program "u title ,,xxi 7includ+ b5efits provid$ "u ! ,*ildr5's ,heal? ,insurance ,program ?r\gh a manag$ c>e arrangem5t71 or a heal? plan1 a ?ird-p>ty entity ) a contract 9 effect "u subsection 7a7 %all-- 7#a7 reque/ & receive1 9 ! mo/ effici5t & lea/ burd5some mann] practicable-- 7,a7 claims-level rebate file data "u section #aibg1 f ,/ate ,m$icaid ag5cies2 7,b7 claims-level data f cov]$ entities2 & 7,c7 any o!r data specifi$ by ! ,secret>y z necess>y = ! entity to c>ry out ?is section2 7#b7 reque/1 receive1 & ma9ta9 data describ$ 9 p>agraph 7#a7 9 a confid5tial mann]2 7#c7 ensure t claims-level data submissions by cov]$ entities are complete & accurate1 & if n1 obta9 complete & accurate data f ! cov]$ entity2 7#d7 notify ! cov]$ entity1 ! ,secret>y1 ! ,/ate ,m$icaid ag5cy1 & ! manufactur] ( any violation describ$ 9 subsection 7c7 to all[ = rem$iation2 7#e7 provide ! manufactur] ( a #cdj;,b drug ) claims-level data submitt$ 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#f7 :]e feasible1 %>e ) a cov]$ entity1 ! ,secret>y1 a ,m$icaid ,/ate ag5cy1 or a manufactur]1 data ! ?ird-p>ty entity id5tifies 9 a timely mann] ) ! purpose ( prev5t+ any ( ! violations describ$ 9 section #bgbi;,a7b77#b7 ( ! ,public ,heal? ,s]vice ,act2 7#g7 det]m9e total sales ( #cdj;,b drugs to su* individuals = purposes ( be+ us$ z ! basis = det]m9+ us] fees "u section #cdj;,b7a77#ae7 ( su* ,act2 & 7#h7 all[ cov]$ entities describ$ 9 subp>agraphs 7,a7 ?r\gh 7,k7 ( section #cdj;,b7a77#d7 ( ! ,public ,heal? ,s]vice ,act1 :i* h ! l[e/ decile ( pati5t volume1 z calculat$ by ! ,secret>y1 to make submissions requir$ "u ?is section 9 an aggregat$ retrospective basis4 7c7 ,h>d%ip exemption ,! ,secret>y may1 on a case-by-case basis1 det]m9e t a cov]$ entity may submit aggregate data if ! ,secret>y det]m9es t x is n feasible = ! entity to submit claims-level data1 z requir$ "u ?is section4 7d7 ,re/rictions on contract+ entity ,! entity receiv+ a contract "u subsection 7a7 %all-- 7#a7 ensure t x has no conflicts ( int]e/1 includ+ no direct contractual involvem5t ) any cov]$ entity1 pay]1 or manufactur] p>ticipat+ 9 ! drug disc\nt program "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act2 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 7b77#a72 & 7#d7 n collect pric+ in=mation reg>d+ drugs t are n #cdj;,b drugs f cov]$ entities4 7e7 ,duties ( cov]$ entity ,cov]$ entities %all facilitate & p>ticipate 9 data transmission ) ! ?ird-p>ty entity ) a contract 9 effect "u subsection 7a71 includ+ ) respect to report+ on data available ?r\gh contract ph>macies4 7f7 ,re/rictions on manufactur] & ,,pbm use ( data 7#a7 ,9 g5]al ,a manufactur] :o receives data "u subsection 7b77#e7 may use su* data only = ! purpose ( prev5t+ duplicate disc\nts & div]sion "u ?is section4 7#b7 ,re/rictions on plans1 issu]s1 & ,p,b,ms ,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 7b77#e7 = 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 pursuant to subp>t ,o ( "p #ajjc ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulations71 subject to ! discretion ( ! ,secret>y4 7g7 ,privacy requirem5ts ,! in=mation ex*ange requir$ by subsection 7b7 %all occur 9 a mann] consi/5t ) ! privacy1 security1 & brea* notification regulations promulgat$ "u section #bfd7;c7 ( ! ,heal? ,insurance ,portability & ,acc\ntability ,act ( #aiif4 7h7 ,repaym5t to manufactur]s ,! ,secret>y %all require a cov]$ entity to "w ) affect$ manufactur]s reg>d+ id5tifi$ duplicate disc\nts = #cdj;,b drugs1 reg>dless ( ! me?od us$ to disp5se ! #cdj;,b drug1 :i* %all include repaym5t-- 7#a7 by ! cov]$ entity z a result ( ! cov]$ entity's noncompliance ) section #cdj;,b ( ! ,public ,heal? ,s]vice ,act2 7#b7 by a ,/ate ,m$icaid program ( rebates improp]ly reque/$ by ! ,/ate ,m$icaid program2 or 7#c7 by a ,/ate ,m$icaid program :]e ! f9ancial b5efit ( ! duplicate disc\nt accrues to ! ,/ate ,m$icaid program1 reg>dless ( :e!r ! duplicate disc\nt occurr$ "u ! fee-=-s]vice or manag$ c>e paym5t arrangem5t4 7i7 ,def9itions ,9 ?is section3 7#a7 #cdj;,b drug ,! t]m #cdj;,b drug means a drug t is-- 7,a7 a cov]$ outpati5t drug 7z def9$ = purposes ( section #cdj;,b ( ! ,public ,heal? ,s]vice ,act72 & 7,b7 pur*as$ "u an agreem5t 9 effect "u su* section4 7#b7 ,cov]$ entity ,! t]m cov]$ entity means an entity describ$ 9 section #cdj;,b7a77#d7 ( ! ,public ,heal? ,s]vice ,act4 7#c7 ,div]sion ,! t]m div]sion1 ) respect to a cov]$ entity & a #cdj;,b drug1 means ! resale or o!rwise transf]r+ ( ! drug to a p]son :o is n a pati5t1 z def9$ 9 section #cdj;,b7b77#c7 ( ! ,public ,heal? ,s]vice ,act1 ( ! cov]$ entity4 7#d7 ,duplicate disc\nt ,! t]m duplicate disc\nt means a paym5t "u title ,,xix = m$ical assi/ance describ$ 9 section #aije7;a77#ab7 ) respect to a #cdj;,b drug if ! drug is subject to ! paym5t ( a rebate to ! ,/ate "u section #aibg4 7#e7 ,heal? plans ,! t]m heal? plan has ! mean+ giv5 to t t]m 9 section #aabh;,c7c74 7#f7 ,manufactur] ,! t]m manufactur] has ! mean+ giv5 to t t]m 9 section #aibg7k77#e74 4 7b7 ,prohibit$ actions ( gr\p heal? plans & ,p,b,ms 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 #bed;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 p5alties1 pursuant to subp>t ,o ( "p #ajjc ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulations71 on any gr\p heal? plan1 heal? insurance issu]1 or entity provid+ ph>macy b5efit managem5t s]vices t violates p>agraph 7#a74 7c7 ,ov]sight ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,adm9i/rator ( ! ,c5t]s = ,m$ic>e ,m$icaid ,s]vices & ! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration1 %all issue a report to ! appropriate committees ( ,congress detail+ coord9at$ ef=ts1 includ+ ?r\gh ! use ( exi/+ res\rces to address duplicate disc\nts4 7d7 ,regulations ,! ,secret>y ( ,heal? & ,human ,s]vices may promulgate su* rules ?r\gh notice & comm5t rulemak+ z ! ,secret>y det]m9es appropriate to 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 ?r\gh ! cle>+h\se e/abli%$ by ! am5dm5t made by subsection 7a74 7e7 ,def9ition ,9 ?is section1 ! t]m duplicate disc\nt has ! mean+ giv5 su* t]m 9 section #aaej;,d7h7 ( ! ,social ,security ,act1 z add$ by subsection 7a74 #aj4 ,pati5t f9ancial assi/ance ,section #cdj;,b7a77#e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a77#e771 z am5d$ by section #h7;b71 is fur!r am5d$ by add+ at ! end ! foll[+3 7,h7 ,pati5t f9ancial assi/ance 7i7 ,9 g5]al ,ea* cov]$ entity %all-- 7,i7 ensure t its f9ancial assi/ance policy is transp>5t to pati5ts at po9t ( c>e & publicly report$2 7,,ii7 apply su* f9ancial assi/ance policy to pati5ts s]v$ by *ild sites & contract ph>macies2 & 7,,iii7 ^u reque/ ( ! ,secret>y1 submit its f9ancial assi/ance policy to ! ,secret>y4 7ii7 ,records ,! ,secret>y %all require cov]$ entities to ma9ta91 = a p]iod ( at lea/ #c ye>s1 auditable records relat$ to ! implem5tation & en=cem5t ( ?is subp>agraph4 7iii7 ,f9ancial assi/ance policy def9$ ,9 ?is subp>agraph1 a f9ancial assi/ance policy means-- 7,i7 7aa7 a writt5 f9ancial assi/ance policy describ$ 9 section #eja7r77#d77;,a7 ( ! ,int]nal ,rev5ue ,code ( #aihf1 provid$1 at lea/1 to pati5ts at #bjj p]c5t ( ! ,f$]al pov]ty level or less2 & 7bb7 a slid+ fee scale = cov]$ outpati5t drugs disp5s$ to pati5ts "u ! drug disc\nt program "u ?is section1 z applicable2 or 7,,ii7 su* o!r alt]native policy z ! ,secret>y may det]m9e ) respect to a specific cov]$ entity4 7iv7 ,ov]sight ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy & report to ,congress on ! impact ( requirem5ts ( ?is subp>agraph on pati5t access to cov]$ outpati5t drugs pur*as$ "u ?is section4 7v7 ,language requirem5ts ,a cov]$ entity %all make ! f9ancial assi/ance policy describ$ 9 clause 7i7 available to pati5ts1 includ+ pati5ts s]v$ by *ild sites & contract ph>macies 9 pla9 language 7z def9$ 9 section #acaa7;e77#c77;,b7( ! ,pati5t ,protection & ,af=dable ,c>e ,act74 7vi7 ,rule ( con/ruction ,compliance ) ?is subp>agraph %all n be consid]$ a prohibit$ act "u section #aabh;,a1 #aabh;,b7b71 or #ahgg ( ! ,social ,security ,act4 7vii7 ,delay$ effective date = c]ta9 entities ,) respect to a *ild site or contract ph>macy1 ! requirem5ts ( ?is subp>agraph %all apply beg9n+ on ! date t is #c ye>s aft] ! date ( enactm5t ( ! ,,su/a9 #cdj;,b ,act4 4 #aa4 ,ensur+ ! equitable treatm5t ( cov]$ entities & ph>macies p>ticipat+ 9 ! #cdj;,b drug disc\nt program 7a7 ,gr\p heal? plan & heal? insurance issu] requirem5ts ,subp>t ,,ii ( "p ,a ( title ,,xxvii ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq47 is am5d$ by add+ at ! end ! foll[+3 #bgbi;,a4 ,requirem5ts relat+ to ! #cdj;,b drug disc\nt program 7a7 ,9 g5]al ,a gr\p heal? plan1 a heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age1 or an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan or issu] may n discrim9ate aga9/ a cov]$ entity1 a #cdj;,b ph>macy1 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 #cdj;,b ph>macy t diff] f ^? appli$ to entities or ph>macies t are n cov]$ entities or #cdj;,b ph>macies on ! basis t ! entity or ph>macy is a cov]$ entity or #cdj;,b ph>macy or t ! entity or #cdj;,b ph>macy disp5ses #cdj;,b drugs1 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 an entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan or issu] may n discrim9ate aga9/ a cov]$ entity1 a #cdj;,b ph>macy1 or a p>ticipant1 b5efici>y1 or enrollee ( su* plan or cov]age by do+ any ( ! foll[+3 7#a7 ,reimburs+ a cov]$ entity or #cdj;,b ph>macy = a quantity ( a #cdj;,b drug 7z def9$ 9 subsection 7d77 9 an am\nt less ?an su* plan1 issu]1 or entity provid+ ph>macy b5efit managem5t s]vices 7z applicable7 w\ld pay to any o!r simil>ly situat$ 7z specifi$ by ! ,secret>y7 entity or ph>macy t is n a cov]$ entity or a #cdj;,b ph>macy = su* quantity ( su* drug on ! basis t ! entity or ph>macy is a cov]$ entity or #cdj;,b ph>macy or t ! entity or ph>macy disp5ses #cdj;,b drugs4 7#b7 ,impos+ any t]ms or conditions on any cov]$ entity or #cdj;,b ph>macy1 ) respect to any ( ! foll[+ t diff] f su* t]ms or conditions appli$ to o!r simil>ly situat$ 7z specifi$ by ! ,secret>y7 entities or ph>macies t are n cov]$ entities or #cdj;,b ph>macies on ! basis t ! entity or ph>macy is a cov]$ entity or #cdj;,b ph>macy or t ! entity or ph>macy disp5ses #cdj;,b drugs3 7,a7 ,fees1 *>gebacks1 clawbacks1 adju/m5ts1 or o!r assessm5ts4 7,b7 ,pr(essional disp5s+ fees4 7,c7 ,re/rictions or requirem5ts reg>d+ p>ticipation 9 /&>d or pref]r$ ph>macy networks4 7,d7 ,requirem5ts relat+ to ! frequ5cy or scope ( audits or to inv5tory managem5t sy/ems us+ g5]ally accept$ acc\nt+ pr9ciples4 7,e7 ,any o!r re/rictions1 conditions1 practices1 or policies t1 z specifi$ by ! ,secret>y1 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 #cdj;,b drug f a cov]$ entity or #cdj;,b 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 #cdj;,b ph>macy to id5tify1 ei!r directly or ?r\gh a ?ird p>ty1 #cdj;,b drugs4 7#e7 ,refus+ to contract ) a cov]$ entity or #cdj;,b ph>macy = reasons o!r ?an ^? t apply equally to entities or ph>macies t are n cov]$ entities or #cdj;,b ph>macies1 or on ! basis t-- 7,a7 ! entity or ph>macy is a cov]$ entity or a #cdj;,b ph>macy2 or 7,b7 ! entity or ph>macy is describ$ 9 any ( subp>agraphs 7,a7 ?r\gh 7,o7 ( section #cdj;,b7a77#d74 7#f7 ,) respect to a gr\p heal? plan or heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age1 d5y+ cov]age ( a drug on ! basis t su* drug is a #cdj;,b drug4 7#g7 ,requir+ a cov]$ entity to make use ( any #cdj;,b ph>macy 9 a mann] t-- 7,a7 does n meet ! requirem5ts set =? 9 section #cdj;,b = ! use ( contract ph>macies2 or 7,b7 is inconsi/5t ) pati5t ne$ & access4 7#h7 ,fail+ to enable ph>macies to di/+ui% at ! po9t-(-sale betwe5 private heal? plans & ,/ate ,m$icaid plans sponsor$ by ! same pay]1 ?r\gh me?ods su* z us+ ! same bank id5tification numb] & processor control numb] to id5tify individual enroll$ 9 bo? types ( plans4 7c7 ,civil monet>y p5alties ,! ,secret>y %all impose monet>y p5alties1 pursuant to subp>t ,o ( "p #ajjc ( title #db1 ,code ( ,f$]al ,regulations 7or any successor regulations71 on any gr\p heal? plan1 heal? insurance issu] (f]+ gr\p or individual heal? insurance cov]age1 or entity provid+ ph>macy b5efit managem5t s]vices on behalf ( su* a plan or issu] t violates ! requirem5ts ( ?is section4 ,su* p5alty %all n exce$ #e1jjj p] violation p] day4 ,! ,secret>y %all issue propos$ regulations to implem5t ?is subsection n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is section & %all f9alize su* regulations n lat] ?an #a ye> aft] su* date ( enactm5t4 ,! p5alties "u ?is subsection may be 9 addition to o!r en=cem5t actions available "u ?is title4 7d7 ,def9itions ,= purposes ( ?is section3 7#a7 ,contract ph>macy ,! t]m contract ph>macy has ! mean+ giv5 su* t]m 9 section #cdj;,b7b74 7#b7 ,cov]$ entity ,! t]m cov]$ entity has ! mean+ giv5 su* t]m 9 section #cdj;,b7a77#d74 7#c7 #cdj;,b drug ,! t]m #cdj;,b drug means a drug t is-- 7,a7 a cov]$ outpati5t drug 7z def9$ = purposes ( section #cdj;,b72 & 7,b7 pur*as$ "u an agreem5t 9 effect "u su* section4 7#d7 #cdj;,b ph>macy ,! t]m #cdj;,b ph>macy means a ph>macy t is :olly-own$ by a cov]$ entity or t is a contract ph>macy4 4 7b7 ,m$ic>e prescription drug plan & ,,ma-,,pd plan requirem5ts ,section #ahfj;,d-#ab ( ! ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7i7 ,nondiscrim9ation 7#a7 ,9 g5]al ,a ,,pdp sponsor (f]+ a prescription drug plan or an ,,ma organization (f]+ an ,,ma-,,pd plan may n require a cov]$ entity to make use ( any #cdj;,b ph>macy 9 a mann] t-- 7,a7 does n meet ! requirem5ts set =? 9 section #cdj;,b ( ! ,public ,heal? ,s]vice ,act = ! use ( #cdj;,b ph>macies2 or 7,b7 is inconsi/5t ) pati5t ne$ & access4 7#b7 ,def9itions ,9 ?is subsection-- 7,a7 ! t]m contract ph>macy has ! mean+ giv5 su* t]m 9 section #cdj;,b7b7 ( ! ,public ,heal? ,s]vice ,act2 7,b7 ! t]m cov]$ entity has ! mean+ giv5 su* t]m 9 section #cdj;,b ( ! ,public ,heal? ,s]vice ,act2 & 7,c7 ! t]m #cdj;,b ph>macy means a ph>macy t is :olly-own$ by a cov]$ entity or t is a contract ph>macy4 4 #ab4 ,us] fee program 7a7 ,9 g5]al ,section #cdj;,b7a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7a771 z am5d$ by section #f7;a71 is fur!r am5d$ by add+ at ! end ! foll[+3 7#ae7 ,us] fee program 7,a7 ,e/abli%m5t ( qu>t]ly fee ,beg9n+ 9 fiscal ye> #bjca1 ! ,secret>y %all 9 accordance ) ?is section assess us] fees on1 & collect su* fees f1 ea* cov]$ entity p>ticipat+ 9 ! program "u ?is section4 ,! fees %all be assess$ = a fiscal ye> & collect$ qu>t]ly dur+ ! la/ #c qu>t]s ( su* fiscal ye> & ! fir/ qu>t] ( ! subsequ5t fiscal ye>1 & ! total am\nt assess$ & collect$ = a fiscal ye> %all be ! am\nt specifi$ 9 subp>agraph 7,b77i7 = su* ye>1 subject to subp>agraph 7,c74 7,b7 ,assessm5t ( us] fees 7i7 ,am\nt ( assessm5t ,! total am\nt ( us] fees au?oriz$ to be assess$ & collect$ "u subsection 7a7 = a fiscal ye> is-- 7,i7 #ej1jjj1jjj = fiscal ye> #bjca2 & 7,,ii7 = fiscal ye> #bjcb & ea* subsequ5t fiscal ye>1 ! am\nt au?oriz$ to be assess$ & collect$ 9 ! previ\s fiscal ye> adju/$ by ! av]age annual p]c5t *ange t occurr$ 9 ! ,consum] ,price ,index = all urban consum]s 7,wa%+ton-,arl+ton-,alex&ria1 ,,dc-,,va-,,md-,,wv2 ,n ,seasonally ,adju/$2 ,all items2 ,annual ,index7 9 ! #ab-mon? p]iod end+ ,june #cj prec$+ ! fiscal ye> = :i* fees are be+ e/abli%$4 7ii7 ,allocations ( assessm5t by cov]$ entity 7,i7 ,9 g5]al ,! total us] fees assess$ & collect$ "u subp>agraph 7,a7 ea* fiscal ye> ) respect to ea* cov]$ entity %all be an am\nt t is equal to ! applicable p]c5tage ( cov]$ outpati5t drugs disp5s$ by su* cov]$ entity = ! fiscal ye> multipli$ by ! am\nt specifi$ 9 clause 7i7 = ! fiscal ye>4 7,,ii7 ,applicable p]c5tage ,= purposes ( subclause 7,i71 ! applicable p]c5tage ( ea* cov]$ entity = a fiscal ye> %all be det]m9$ by-- 7aa7 divid+-- 7,,aa7 ! numb] ( prescriptions = cov]$ outpati5t drugs disp5s$ by ! cov]$ entity 9 ! previ\s fiscal ye>2 by 7,,bb7 ! total numb] ( prescriptions = cov]$ outpati5t drugs disp5s$ by all cov]$ entities 9 su* fiscal ye>2 & 7bb7 multiply+ ! am\nt det]m9$ "u item 7aa7 by #ajj4 7iii7 ,tim+ ( assessm5t ,! ,secret>y %all notify ea* cov]$ entity subject to ?is section ( ! am\nt ( ! annual assessm5t impos$ on su* cov]$ entity "u ?is subsection n lat] ?an ,decemb] #ca ( ! fiscal ye> = :i* su* fees apply4 ,paym5ts ( su* assessm5ts %all be made 9 #d equal in/allm5ts1 :i* %all be made by ! la/ day ( ea* qu>t] ( ! cal5d> ye> imm$iately foll[+ ! notification4 7,c7 ,use ( fees ,any fee collect$ "u ?is p>agraph %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/em72 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 may promulgate rules ?r\gh notice & comm5t rulemak+ z necess>y to c>ry out ! 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#ae7 = ! curr5t ye>1 aft] p>agraph 7#e74 #ac4 ,/udies & reports 7a7 ,,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* section #cdj;,b4 7b7 ,,hhs /udy & report ,= ! purpose ( e/abli%+ reasonable disp5s+ fees = purposes ( ! drug disc\nt program "u section #cdj;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b71 ! ,secret>y ( ,heal? & ,human ,s]vices %all-- 7#a7 conduct a /udy on su* disp5s+ fees2 & 7#b7 n lat] ?an #b ye>s aft] ! date ( enactm5t ( ?is ,act1 submit to ,congress a report on ! /udy "u p>agraph 7#a74 7c7 ,,aspe /udy ,! ,assi/ant ,secret>y = ,plann+ & ,evaluation 7ref]r$ to 9 ?is subsection z ! ,assi/ant ,secret>y7 %all conduct a /udy on ! int]actions ( ! cle>+h\se e/abli%$ "u section #aaej;,d ( ! ,social ,security ,act 7z add$ by section #i7 & any data collection sy/em e/abli%$ by ! ,secret>y to c>ry out section #aaic7;d7 ( ! ,social ,security ,act 7#db ,u4,s4,c4 #acbj;f-#b7;d77 or section #ahfj;,d-#ad;,b7b77#a77;,b7 ( su* ,act 7#db ,u4,s4,c4 #aciew-#aad;b7b77#a77;,b77 to limit duplicative disc\nts = outpati5t prescription drugs4 ,! ,assi/ant ,secret>y %all make recomm5dations to ,congress on ways to /reaml9e & effectively op]ate su* cle>+h\se & data collection sy/ems4 #ad4 ,additional res\rces 7a7 ,fund+ ,section #cdj;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7d77#d77 is am5d$ by add+ at ! end ! foll[+3 7f7 ,au?orization ( 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$1 to ! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 #c1jjj1jjj = ea* ( fiscal ye>s #bjbg ?r\gh #bjca1 = purposes ( conduct+ audits1 inve/igations1 & o!r ov]sight & en=cem5t activities ) respect to ! drug disc\nt program "u ?is section4 7#b7 ,au?orization ( appropriations = g5]al purposes ,9 addition to am\nts made available "u p>agraph 7#a7 & subsection 7d77#d71 !re are au?oriz$ to be appropriat$ #i1jjj1jjj = ea* ( fiscal ye>s #bjbg ?r\gh #bjcj1 = purposes ( implem5t+ ! activities "u ?is section1 z add$ by ! ,,su/a9 #cdj;,b ,act4 4 7b7 ,hir+ au?ority2 regulations ,section #cdj;,b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b71 z am5d$ by subsection 7a71 is fur!r am5d$ by add+ at ! end ! foll[+3 7g7 ,hir+ au?ority ,! ,adm9i/rator ( ! ,heal? ,res\rces & ,s]vices ,adm9i/ration may hire su* additional /aff z may be necess>y = purposes ( c>ry+ out ?is section4 7h7 ,regulations ,! ,secret>y %all promulgate regulations ?r\gh notice & comm5t rulemak+1 z appropriate to implem5t ?is section4 4 #ae4 ,def9itions ,section #cdj;,b7b7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bef;b7b771 z am5d$ by section #d7;a71 is fur!r am5d$ by add+ at ! end ! foll[+3 7#f7 ,*ild site ,9 ?is section1 ! t]m *ild site means a site t is :olly-own$ & op]at$ by a cov]$ entity4 7#g7 ,contract ph>macy ,9 ?is section1 ! t]m contract ph>macy means a ph>macy ) :i* a cov]$ entity has contract$ to disp5se cov]$ outpati5t drugs on behalf ( ! cov]$ entity :e!r di/ribut$ 9 p]son or via mail4 4 #af4 ,effective date ,?is ,act1 includ+ ! am5dm5ts made by ?is ,act1 %all take effect on ! date ( enactm5t ( ?is ,act4